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nyse:syk
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Stryker
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Apr 26th, 2022 12:00AM
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Oct 24th, 2018 12:00AM
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https://www.uspto.gov?id=US11311413-20220426
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Thermal system with medication interaction
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A thermal control unit supplies temperature controlled fluid to a patient to control the patient's temperature. The thermal control unit includes a fluid outlet, fluid inlet, heat exchanger, pump, patient temperature probe port, user interface, and controller. The controller receives patient temperature readings from the patient temperature probe port and controls a temperature of the circulating fluid in a first manner when no event data is received regarding treatment of the patient. The controller controls a temperature of the circulating fluid in a second and different manner when event data is received. The event data may relate to medication and/or fluid administered to the patient. The different manners include determining a target fluid temperature in using different inputs and/or alarming in different manners. In some cases, the controller pauses the use of the patient temperature readings while continuing to deliver temperature controlled fluid to the patient.
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11311413
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1. A thermal control unit for controlling a temperature of a patient, the thermal control unit comprising:
a fluid outlet adapted to fluidly couple to a fluid supply line;
a fluid inlet adapted to fluidly couple to a fluid return line;
a circulation channel coupled to the fluid outlet and the fluid inlet;
a pump for circulating fluid through the circulation channel from the fluid inlet to the fluid outlet;
a heat exchanger for controlling a temperature of the circulating fluid in the circulation channel;
a fluid temperature sensor adapted to sense the temperature of the circulating fluid;
a patient temperature probe port adapted to receive patient temperature readings from a patient temperature probe;
a user interface including a pause control and a patient target temperature input; and
a controller in communication with the patient temperature probe port, the fluid temperature sensor, and the user interface, the controller adapted to use the patient temperature readings to control the temperature of the circulating fluid when the pause control is not activated, and to pause using the patient temperature readings to control the temperature of the circulating fluid when the pause control is activated while the controller continues to pump the circulating fluid out of the fluid outlet to the patient.
2. The thermal control unit of claim 1 wherein the controller pauses for a predefined amount of time, and thereafter resumes utilizing the patient temperature readings to control the temperature of the circulating fluid.
3. The thermal control unit of claim 1 wherein the controller sets a target temperature of the circulating fluid to a value that is based on a current patient temperature reading when the pause control is not activated and the controller sets a target temperature of the circulating fluid to a value that is based on a previous patient temperature reading when the pause control is activated.
4. The thermal control unit of claim 1 wherein the controller is adapted to use the patient temperature readings to control the temperature of the circulating fluid when the pause control is not activated and to use assumed patient temperature readings when the pause control is activated.
5. The thermal control unit of claim 1 wherein the controller records a patient temperature reading when pausing the use of patient temperature readings to control the temperature of the circulating fluid, and the controller pauses until a current patient temperature reading returns to within a threshold of the recorded patient temperature reading.
6. The thermal control unit of claim 1 wherein the user interface is adapted to allow a user to input event data regarding a patient treatment event and the pause control is automatically activated when event data is input into the user interface, and wherein the event data includes at least one of the following: a particular medication administered to the patient and fluid administered to the patient at a location adjacent to the patient temperature probe.
7. The thermal control unit of claim 6 wherein the controller pauses using the patient temperature readings for varying amounts of time based on at least one of the particular medication and an amount of the particular medication.
8. A thermal control unit for controlling a temperature of a patient, the thermal control unit comprising:
a fluid outlet adapted to fluidly couple to a fluid supply line;
a fluid inlet adapted to fluidly couple to a fluid return line;
a circulation channel coupled to the fluid outlet and the fluid inlet;
a pump for circulating fluid through the circulation channel from the fluid inlet to the fluid outlet;
a heat exchanger for controlling a temperature of the circulating fluid in the circulation channel;
a fluid temperature sensor adapted to sense the temperature of the circulating fluid;
a patient temperature probe port adapted to receive patient temperature readings from a patient temperature probe;
a user interface adapted to receive a patient target temperature and event data regarding a patient treatment event; and
a controller in communication with the patient temperature probe port, the fluid temperature sensor, and the user interface, the controller adapted to issue an alarm if the patient temperature readings deviate from a predefined criterion when no event data is entered via the user interface, and the controller adapted to not issue the alarm if the patient temperature readings deviate from the predefined criterion when event data is entered via the user interface.
9. The thermal control unit of claim 8 wherein, when event data is entered via the user interface, the controller does not issue the alarm for a predefined time period.
10. The thermal control unit of claim 9 wherein the predefined time period lasts until a current patient temperature reading returns to within a threshold of a previous patient temperature reading recorded prior to the event data being entered.
11. The thermal control unit of claim 9 wherein, after expiration of the predefined time period, the controller issues the alarm if the patient temperature readings deviate from the predefined criterion.
12. The thermal control unit of claim 9 wherein the controller uses the patient temperature readings to control the temperature of the circulating fluid when no event data is received, and to pause using the patient temperature readings to control the temperature of the circulating fluid when event data is received.
13. The thermal control unit of claim 12 wherein the controller is adapted to continue to pump the circulating fluid out of the fluid outlet to the patient while the controller pauses its use of the patient temperature readings to control the temperature of the circulating fluid when event data is received; and the controller is further adapted to pause its use of the patient temperature readings to control the temperature of the circulating fluid for the predefined time period.
14. The thermal control unit of claim 12 wherein the controller sets a target temperature of the circulating fluid to a value that is based on a current patient temperature reading when no event data is received and the controller sets the target temperature of the circulating fluid to a value that is based on a previous patient temperature reading when event data is received.
15. The thermal control unit of claim 14 wherein the controller records a patient temperature reading when pausing the use of the patient temperature readings to control the temperature of the circulating fluid, and the controller pauses until the current patient temperature reading returns to within a threshold of the recorded patient temperature reading.
16. A thermal control unit for controlling a temperature of a patient, the thermal control unit comprising:
a fluid outlet adapted to fluidly couple to a fluid supply line;
a fluid inlet adapted to fluidly couple to a fluid return line;
a circulation channel coupled to the fluid outlet and the fluid inlet;
a pump for circulating fluid through the circulation channel from the fluid inlet to the fluid outlet;
a heat exchanger for controlling a temperature of the circulating fluid in the circulation channel;
a fluid temperature sensor adapted to sense the temperature of the circulting fluid;
a patient temperature probe port adapted to receive patient temperature readings from a patient temperature probe;
a user interface adapted to receive a patient target temperature and event data regarding a patient treatment event; and
a controller in communication with the patient temperature probe port, the fluid temperature sensor, and the user interface, the controller adapted to use the patient temperature reading to control the temperature of the circulating fluid when no event data is received, and to use assumed patient temperature readings when event data is received.
17. The thermal control unit of claim 16 wherein the assumed patient temperature readings are generated by the controller based upon a trend in the patient's temperature readings prior to the event data being received.
18. The thermal control unit of claim 17 wherein the controller uses the assumed patient temperature readings for a predefined time period to determine a target temperature for the circulating fluid, and the controller predicts a patient temperature reading at an expiration of the predefined time period.
19. The thermal control unit of claim 18 wherein the predefined time period is one of a fixed amount of time and a variable amount of time that lasts until a current patient temperature reading falls within a predefined range of the predicted patient temperature, and wherein the event data indicates at least one of administration of a medication to the patient and supplying fluid to the patient at a location adjacent the patient temperature probe.
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CROSS-REFERENCE TO RELATED APPLICATIONS
This application claims priority to commonly assigned U.S. provisional patent application Ser. No. 62/577,772 filed Oct. 27, 2017, by inventors Gregory Taylor et al. and entitled THERMAL SYSTEM WITH MEDICATION INTERACTION, the complete disclosure of which is incorporated herein by reference.
BACKGROUND
The present invention relates to a thermal control system for controlling the temperature of circulating fluid that is delivered to one or more thermal pads positioned in contact with a patient.
Thermal control systems are known in the art for controlling the temperature of a patient by providing a thermal control unit that supplies temperature controlled fluid to one or more thermal pads positioned in contact with a patient and/or to one or more catheters positioned inside the patient. The thermal control unit includes one or more heat exchangers for controlling the temperature of the fluid and a pump that pumps the temperature controlled fluid to the pad(s) and/or catheter(s). After passing through the pad(s) or catheter(s), the fluid is returned to the thermal control unit where any necessary adjustments to the temperature of the returning fluid are made before being pumped back to the pad(s) and/or catheter(s).
In some instances, the temperature of the fluid is controlled to a static target temperature, while in other instances the temperature of the fluid is varied as necessary in order to automatically effectuate a target patient temperature. When the thermal control unit automatically controls the temperature of the circulating fluid in order to effectuate a desired patient temperature, the thermal control unit utilizes patient temperature measurements in a closed-loop feedback manner. The closed loop feedback gives the thermal control unit knowledge of the patient's temperature, which it uses to determine whether to heat or cool the circulating fluid, or to maintain the circulating fluid at its current temperature.
SUMMARY
In some instances, the temperature readings from one or more patient temperature probes provide patient temperature information that is not indicative of the action of the thermal control unit in controlling the patient's temperature. For example, in some instances, the patient undergoing thermal treatment is given one or more medications that are known to raise or lower the patient's temperature. In other instances, the patient is given a medication or fluid at a location adjacent to the patient temperature probe, and the temperature of the medication or fluid changes the temperature measured by the patient temperature probe. According to some embodiments, the present disclosure provides an improved thermal control unit that addresses these and other situations where the patient temperature readings are affected by one or more extraneous events. The present disclosure also provides an improved thermal control unit that allows automatic selecting of patient target temperatures in response to one or more extraneous events, such as, but not limited to, the administration of one or more medications to the patient.
According to one embodiment of the present disclosure, a thermal control unit for controlling the temperature of a patient is provided. The thermal control unit includes a fluid outlet, fluid inlet, heat exchanger, pump, user interface, and controller. The fluid outlet is adapted to fluidly couple to a fluid supply line and the fluid inlet is adapted to fluidly couple to a fluid return line. The pump circulates fluid from the fluid inlet through the heat exchanger and to the fluid outlet. The user interface receives event data regarding a patient treatment event. The controller controls a temperature of the circulating fluid in a first manner if event data is not received and controls a temperature of the circulating fluid in a second manner if event data is received, wherein the first manner is different from the second manner.
According to another aspect of the present disclosure, the event data indicates administration of a medication to the patient. The second manner may include supplying warmer circulating fluid to the patient than the first manner if the medication is one of a paralytic and a sedative.
In some embodiments, the first manner includes controlling the temperature of the circulating fluid using actual patient temperature readings and the second manner includes controlling the temperature of the circulating fluid using assumed patient temperature readings.
The controller may operate in the second manner for a predefined amount of time and thereafter automatically switch back to operating in the first manner.
According to some embodiments, the thermal control unit further comprises a patient temperature probe port adapted to receive patient temperature readings from a patient temperature probe. In such embodiments, the first manner includes using the patient temperature readings to control the temperature of the circulating fluid, and the second manner includes not using the patient temperature readings to control the temperature of the circulating fluid.
According to another aspect of the present disclosure, a thermal control unit is provided for controlling a temperature of a patient. The thermal control unit includes a fluid outlet, fluid inlet, circulation channel, pump, heat exchanger, fluid temperature sensor, patient temperature probe port, user interface, and controller. The fluid outlet is adapted to fluidly couple to a fluid supply line and the fluid inlet is adapted to fluidly couple to a fluid return line. The circulation channel is fluidly coupled to the fluid outlet and the fluid inlet. The pump circulates fluid through the circulation channel from the fluid inlet to the fluid outlet. The heat exchanger controls a temperature of the fluid circulating in the circulation channel. The fluid temperature sensor senses a temperature of the circulating fluid. The patient temperature probe port is adapted to receive patient temperature readings from a patient temperature probe. The user interface includes a pause control and an input for receiving a patient target temperature. The controller uses the patient temperature readings to control a temperature of the circulating fluid when the pause control is not activated and pauses using the patient temperature readings to control the temperature of the circulating fluid when the pause control is activated.
According to other aspects of the present disclosure, the controller pauses for a predefined amount of time, and thereafter resumes utilizing the patient temperature readings to control the temperature of the circulating fluid.
The controller continues to pump the circulating fluid out of the fluid outlet to the patient while the controller pauses its use of the patient temperature readings to control the temperature of the circulating fluid.
In some embodiments, the controller sets a target temperature of the circulating fluid to a value that is based on a current patient temperature reading when the pause control is not activated. When the pause control is activated, the controller sets a target temperature of the circulating fluid to a value that is based on a previous patient temperature reading.
In some embodiments, the controller uses actual patient temperature readings to control a temperature of the circulating fluid when the pause control is not activated and uses assumed patient temperature readings when the pause control is activated. The assumed patient temperature readings may be predicted from past temperature readings, may be inferred from other readings (e.g. an amount of heat transferred to/from the patient), and/or may be generated from a combination of predictions and inferences.
The controller may record a patient temperature reading when pausing the use of patient temperature readings to control the temperature of the circulating fluid. When so recorded, the controller continues to pause until a current patient temperature reading returns to within a threshold of the recorded patient temperature reading.
The user interface, in some embodiments, is adapted to allow a user to indicate a type of event regarding patient treatment. The type of event includes at least one of the following: a particular medication administered to the patient and fluid administered to the patient at a location adjacent to the patient temperature probe (such as fluid used to clean or flush a patient temperature probe, or fluid used for other purposes).
The controller may pause using the patient temperature readings for varying amounts of time based on at least one of the following: the particular medication, the amount of the particular medication, and/or the amount of fluid applied to the patient at the situs of the patient temperature probe.
According to another embodiment of the present disclosure, a thermal control unit for controlling a temperature of a patient is provided. The thermal control unit includes a fluid outlet, fluid inlet, circulation channel, pump, heat exchanger, fluid temperature sensor, patient temperature probe port, user interface, and controller. The fluid outlet is adapted to fluidly couple to a fluid supply line and the fluid inlet is adapted to fluidly couple to a fluid return line. The circulation channel fluidly couples the fluid outlet and the fluid inlet. The pump circulates fluid through the circulation channel from the fluid inlet to the fluid outlet. The heat exchanger controls a temperature of the fluid circulating in the circulation channel. The fluid temperature sensor senses a temperature of the circulating fluid and the patient temperature probe port is adapted to receive patient temperature readings from a patient temperature probe. The user interface is adapted to receive a patient target temperature and event data regarding a patient treatment event. The controller issues an alarm if the patient temperature readings deviate from a predefined criterion when no event data is entered via the user interface. The controller also is adapted to not issue the alarm if the patient temperature readings deviate from the predefined criterion when event data is entered via the user interface.
According to other aspects, when event data is entered via the user interface, the controller does not issue the alarm for a predefined time period, which may be a fixed amount of time or it may be a variable amount of time that lasts until a current patient temperature reading returns to within a threshold of a previous patient temperature reading recorded prior to the event data being entered. However measured, after expiration of the predefined time period, the controller issues the alarm if the patient temperature readings deviate from the predefined criterion.
In some embodiments, the predefined criterion is a maximum rate of change of the patient temperature readings coming from the patient temperature probe.
In some embodiments, the controller uses the patient temperature readings to control a temperature of the circulating fluid when no event data is received, and pauses using the patient temperature readings to control the temperature of the circulating fluid when event data is received. When pausing the use of patient temperature readings to control the temperature of the circulating fluid, the controller continues to pump the circulating fluid out of the fluid outlet to the patient.
Also or additionally, the controller may be configured to set a target temperature of the circulating fluid to a value that is based on a current patient temperature reading when no event data is received, and set a target temperature of the circulating fluid to a value that is based on a previous patient temperature reading when event data is received. The previous patient temperature reading may be used to predict a current patient temperature reading.
According to another embodiment of the present disclosure, a thermal control unit for controlling a temperature of a patient is provided. The thermal control unit includes a fluid outlet, fluid inlet, circulation channel, pump, heat exchanger, fluid temperature sensor, patient temperature probe port, user interface, and controller. The fluid outlet is adapted to fluidly couple to a fluid supply line and the fluid inlet is adapted to fluidly couple to a fluid return line. The circulation channel is coupled to the fluid outlet and the fluid inlet and the pump circulates fluid through the circulation channel from the fluid inlet to the fluid outlet. The heat exchanger controls a temperature of the fluid circulating in the circulation channel. The fluid temperature sensor senses a temperature of the circulating fluid and the patient temperature probe port receives patient temperature readings from a patient temperature probe. The user interface receives a patient target temperature and event data regarding a patient treatment event. The controller uses the patient temperature readings to control a temperature of the circulating fluid when no event data is received, and uses assumed patient temperature readings when event data is received.
According to other aspects, the assumed patient temperature readings are generated by the controller based upon a trend in the patient's temperature readings prior to the event data being received.
The controller, in some embodiments, uses the assumed patient temperature readings to determine a target temperature for the circulating fluid.
In some embodiments, the controller uses assumed patient temperature readings for a predefined time period.
The controller may also or alternatively predict an expected patient temperature reading at an expiration of the predefined time period. The predefined time period is one of a fixed amount of time and a variable amount of time that lasts until a current patient temperature reading falls within a predefined range of the expected patient temperature.
Before the various embodiments disclosed herein are explained in detail, it is to be understood that the claims are not to be limited to the details of operation or to the details of construction, nor to the arrangement of the components set forth in the following description or illustrated in the drawings. The embodiments described herein are capable of being practiced or being carried out in alternative ways not expressly disclosed herein. Also, it is to be understood that the phraseology and terminology used herein are for the purpose of description and should not be regarded as limiting. The use of “including” and “comprising” and variations thereof is meant to encompass the items listed thereafter and equivalents thereof as well as additional items and equivalents thereof. Further, enumeration may be used in the description of various embodiments. Unless otherwise expressly stated, the use of enumeration should not be construed as limiting the claims to any specific order or number of components. Nor should the use of enumeration be construed as excluding from the scope of the claims any additional steps or components that might be combined with or into the enumerated steps or components.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective view of a thermal control system according to one aspect of the present disclosure shown applied to a patient on a patient support apparatus;
FIG. 2 is a perspective view of the thermal control unit of the thermal control system of FIG. 1;
FIG. 3 is a block diagram of a control system for the thermal control unit of FIGS. 1 & 2;
FIG. 4 is an illustrative control loop diagram followed in at least one embodiment of the thermal control unit of FIGS. 1 & 2;
FIG. 5 is a graph of a patient target temperature, patient measured temperature, and fluid temperature illustrating a first manner of response of the thermal control unit to the administration of a fluid or medication to a patient;
FIG. 6 is an enlargement of a portion of the graph of FIG. 5 illustrating inaccurate patient temperature readings and predicted patient temperature readings; and
FIG. 7 is a graph of a patient target temperature, patient measured temperature, and fluid temperature illustrating a second manner of response of the thermal control unit to the administration of a sedative to the patient.
DETAILED DESCRIPTION OF THE EMBODIMENTS
A thermal control system 20 according to one embodiment of the present disclosure is shown in FIG. 1. Thermal control system 20 is adapted to control the temperature of a patient 30, which may involve raising, lowering, or maintaining the patient's temperature, or combinations thereof. Thermal control system 20 includes a thermal control unit 22 coupled to one or more thermal therapy devices 24. The thermal therapy devices 24 are illustrated in FIG. 1 to be thermal pads, but it will be understood that thermal therapy devices 24 may take on other forms, such as, but not limited to, blankets, vests, patches, caps, catheters, or other structures that receive temperature controlled fluid. For purposes of the following written description, thermal therapy devices 24 will be referred to as thermal pads 24, but it will be understood by those skilled in the art that this terminology is used merely for convenience and that the phrase “thermal pad” is intended to cover all of the different variations of thermal therapy devices 24 mentioned above (e.g. blankets, vests, patches, caps, catheters, etc.).
Thermal control unit 22 is coupled to thermal pads 24 via a plurality of hoses 26. Thermal control unit 22 delivers temperature controlled fluid (such as, but not limited to, water or a water mixture) to the thermal pads 24 via the fluid supply hoses 26a. After the temperature controlled fluid has passed through thermal pads 24, thermal control unit 22 receives the temperature controlled fluid back from thermal pads 24 via the return hoses 26b.
In the embodiment of thermal control system 20 shown in FIG. 1, three thermal pads 24 are used in the treatment of patient 30. A first thermal pad 24 is wrapped around a patient's torso, while second and third thermal pads 24 are wrapped, respectively, around the patient's right and left legs. Other configurations can be used and different numbers of thermal pads 24 may be used with thermal control unit 22, depending upon the number of inlet and outlet ports that are included with thermal control unit 22. By controlling the temperature of the fluid delivered to thermal pads 24 via supply hoses 26a, the temperature of the patient 30 can be controlled via the close contact of the pads 24 with the patient 30 and the resultant heat transfer therebetween.
Thermal control unit 22 is adapted to raise or lower the temperature of the fluid supplied to thermal pads 24. As shown in FIG. 3, thermal control unit 22 includes a pump 32 for circulating fluid through a circulation channel 34. Pump 32, when activated, circulates the fluid through circulation channel 34 in the direction of arrows 36 (clockwise in FIG. 3). Starting at pump 32 the circulating fluid first passes through a heat exchanger 38 where it is delivered to an outlet manifold 40 having an outlet temperature sensor 42 and a plurality of outlet ports 44. Temperature sensor 42 is adapted to detect a temperature of the fluid inside of outlet manifold 40 and report it to a controller 46.
Outlet ports 44 are coupled to supply hoses 26a. Supply hoses 26a are coupled, in turn, to thermal pads 24 and deliver temperature controlled fluid to the thermal pads 24. The temperature controlled fluid, after passing through the thermal pads, is returned to thermal control unit 22 via return hoses 26b. Return hoses 26b couple to a plurality of inlet ports 50. Inlet ports 50 are fluidly coupled to an inlet manifold 52 inside of thermal control unit 22.
Control unit 22 also includes a bypass line 54 fluidly coupled to outlet manifold 40 and inlet manifold 52 (FIG. 3). Bypass line 54 allows fluid to circulate through circulation channel 34 even in the absence of any thermal pads 24 or hoses 26a being coupled to any of outlet ports 44. In the illustrated embodiment, bypass line 54 includes an optional filter 56 that is adapted to filter the circulating fluid. If included, filter 56 may be a particle filter adapted to filter out particles within the circulating fluid that exceed a size threshold, or filter 56 may be a biological filter adapted to purify or sanitize the circulating fluid, or it may be a combination of both. In some embodiments, filter 56 is constructed and/or positioned within thermal control unit 22 in any of the manners disclosed in commonly assigned U.S. patent application Ser. No. 62/404,676 filed Oct. 11, 2016, by inventors Marko Kostic et al. and entitled THERMAL CONTROL SYSTEM, the complete disclosure of which is incorporated herein by reference.
The incoming fluid flowing into inlet manifold 52 from inlet ports 50 and bypass line 54 travels back toward the pump 32 into an air separator 58. Air separator 58 includes any structure in which the flow of fluid slows down sufficiently to allow air bubbles contained within the circulating fluid to float upwardly and escape to the ambient surrounding. In some embodiments, air separator 58 is constructed in accordance with any of the configurations disclosed in commonly assigned U.S. patent application Ser. No. 62/361,124 filed Jul. 12, 2016, by inventor Gregory S. Taylor and entitled THERMAL CONTROL SYSTEM, the complete disclosure of which is hereby incorporated herein by reference. After passing through air separator 58, the circulating fluid flows past a valve 60 positioned beneath a fluid reservoir 62. Fluid reservoir 62 supplies fluid to thermal control unit 22 and circulation channel 34 via valve 60, which may be a conventional check valve, or other type of valve, that automatically opens when reservoir 62 is coupled to thermal control unit 22 and that automatically closes when reservoir 62 is decoupled from thermal control unit 22 (see FIG. 2). After passing by valve 60, the circulating fluid travels to pump 32 and the circuit is repeated.
Controller 46 of thermal control unit 22 is contained within a main body of thermal control unit 22 and is in electrical communication with pump 32, heat exchanger 38, outlet temperature sensor 42, and a user interface 64. Controller 46 includes any and all electrical circuitry and components necessary to carry out the functions and algorithms described herein, as would be known to one of ordinary skill in the art. Generally speaking, controller 46 may include one or more microcontrollers, microprocessors, and/or other programmable electronics that are programmed to carry out the functions described herein. It will be understood that controller 46 may also include other electronic components that are programmed to carry out the functions described herein, or that support the microcontrollers, microprocessors, and/or other electronics. The other electronic components include, but are not limited to, one or more field programmable gate arrays, systems on a chip, volatile or nonvolatile memory, discrete circuitry, integrated circuits, application specific integrated circuits (ASICs) and/or other hardware, software, or firmware, as would be known to one of ordinary skill in the art. Such components can be physically configured in any suitable manner, such as by mounting them to one or more circuit boards, or arranging them in other manners, whether combined into a single unit or distributed across multiple units. Such components may be physically distributed in different positions in thermal control unit 22, or they may reside in a common location within thermal control unit 22. When physically distributed, the components may communicate using any suitable serial or parallel communication protocol, such as, but not limited to, CAN, LIN, Firewire, I-squared-C, RS-232, RS-465, universal serial bus (USB), etc.
User interface 64, which may be implemented as a control panel or in other manners, allows a user to operate thermal control unit 22. User interface 64 communicates with controller 46 and includes controls enabling a user to turn control unit 22 on and off, one or more controls enabling the user to select a target temperature for the fluid delivered to thermal pads 24, at least one control 66a allowing a user to set a target patient temperature, a pause/event control 66b, a medication control 66c, an automatic temperature adjustment control 66d, and/or other controls. Pause/event control 66b allows a user to pause the use of patient temperature readings from a patient temperature probe 88 (FIG. 3) during thermal treatment of the patient, as will be explained in greater detail below. In some embodiments, pause/event control 66b may be separated into multiple controls: one for carrying out a pause and another for inputting event data. In still other embodiments, the functions associated with pause/event control 66b may be accessed and/or controlled in other manners, such as through the use of one or more switches, buttons, dials, and/or the like. Medication control 66c and temperature adjustment control 66d are explained in greater detail below and, in some embodiments, may be combined with pause/event control 66b and/or each other. In some embodiments, user interface 64 may be located and/or duplicated at an off-board location, such as on a smart phone, a portable computer, a dedicated remote control for thermal control unit 22, and/or on other devices and/or at other locations.
In some embodiments, user interface 64 also allows a user to select from different modes for controlling the patient's temperature. These include, but are not limited to, a manual mode and an automatic mode, both of which may be used for cooling and heating the patient. In the manual mode, a user selects a target temperature for the fluid that circulates within thermal control unit 22 and that is delivered to thermal pads 24. Control unit 22 then makes adjustments to heat exchanger 38 in order to ensure that the temperature of the fluid exiting supply hoses 26a is at the user-selected temperature.
Another one of the modes is an automatic mode. When the user selects the automatic mode, the user selects a target patient temperature, rather than a target fluid temperature. After selecting the target patient temperature, controller 46 makes automatic adjustments to the temperature of the fluid in order to bring the patient's temperature to the desired patient target temperature. In this mode, the temperature of the circulating fluid may vary as necessary in order to bring about the target patient temperature.
In order to carry out the automatic mode, thermal control unit 22 includes one or more patient temperature probe ports 68 (FIGS. 2 & 3) that are adapted to receive one or more conventional patient temperature probes 88. The patient temperature probes may be any suitable patient temperature probe that is able to sense the temperature of the patient at the location of the probe. In one embodiment, the patient temperature probes are conventional Y.S.I. 400 probes marketed by YSI Incorporated of Yellow Springs, Ohio, or probes that are YSI 400 compliant. In other embodiments, different types of probes may be used with thermal control unit 22. Regardless of the specific type of patient temperature probe used in system 20, each temperature probe is connected to a patient temperature probe port 68 positioned on control unit 22. Patient temperature probe ports 68 are in electrical communication with controller 46 and provide current temperature readings of the patient's temperature.
FIG. 4 illustrates a pair of feedback loops 70a and 70b that are used in at least one embodiment of thermal control unit 22. Feedback loop 70a is used by controller 46 when thermal control unit 22 is operating in the manual mode and feedback loops 70a and 70b are both used by controller 46 when thermal control unit 22 is operating in the automatic mode. Feedback loop 70a uses a measured fluid temperature 72 and a fluid target temperature 74 as inputs. Measured fluid temperature 72 comes from outlet temperature sensor 42. Fluid target temperature 74, when thermal control unit 22 is operating in the manual mode, comes from a user inputting a desired fluid temperature. When thermal control unit 22 is operating in the automatic mode, fluid target temperature 74 comes from the output of control loop 70b, as discussed more below.
Control loop 70a determines the difference between the fluid target temperature 74 and the measured fluid temperature 72 (TFerror) and uses the resulting error value as an input into a conventional Proportional, Integral, Derivative (PID) control loop. That is, controller 46 multiplies the fluid temperature error by a proportional constant (CP) at step 76, determines the derivative of the fluid temperature error over time and multiplies it by a constant (CD), and determines the integral of the fluid temperature error over time and multiplies it by a constant (CI) at step 80. The results of steps 76, 78, and 80 are summed together and converted to a heating/cooling command at step 82. The heating/cooling command is fed to heat exchanger 38 and tells heat exchanger 38 whether to heat and/or cool the circulating fluid and how much heating/cooling power to use.
Control loop 70b which, as noted, is used during the automatic mode, determines the difference between a patient target temperature 84 and a measured patient temperature 86. Patient target temperature 84 is input by a user of thermal control unit 22 using control 66a of user interface 64. Measured patient temperature 86 comes from a patient temperature probe 88 coupled to one of patient temperature probe ports 68. Controller 46 determines the difference between the patient target temperature 84 and the measured patient temperature 86 (TPerror) and uses the resulting patient temperature error value as an input into a conventional PID control loop. As part of the PID loop, controller 46 multiples the patient temperature error by a proportional constant (KP) at step 90, multiplies a derivative of the patient temperature error over time by a derivative constant (KD) at step 92, and multiplies an integral of the patient temperature error over time by an integral constant (KI) at step 94. The results of steps 90, 92, and 94 are summed together and converted to a target fluid temperature value 74. The target fluid temperature value 74 is then fed to control loop 70a, which uses it to compute a fluid temperature error, as discussed above.
It will be understood by those skilled in the art that although FIG. 4 illustrates two PID control loops 70a and 70b, other types of control loops may be used. For example, loops 70a and/or 70b can be replaced by one or more PI loops, PD loops, and/or other types of control equations. Controller 46 implements loops 70a and/or 70b multiple times a second in at least one embodiment, although it will be understood that this rate may be varied widely. After controller 46 has output a heat/cool command at step 82 to heat exchanger 38, controller 46 takes another patient temperature reading 86 and/or another fluid temperature reading 72 and re-performs loops 70a and/or 70b. The specific loop(s) used, as noted previously, depends upon whether thermal control unit 22 is operating in the manual mode or automatic mode.
When thermal control unit 22 is operating in the automatic mode, controller 46 continuously implements control loops 70b and 70a. However, if a user activates pause/event control 66b, controller 46 carries out control loops 70b and 70a in a manner different than it does when pause/event control 66b is not activated. Specifically, when pause/event control 66b is not activated, control loop 70b is executed by controller 46 using measured patient temperatures 86 that come from patient temperature probe 88. However, when pause/event control 66b is activated, controller 46 modifies control loop 70b so that, instead of using measured patient temperature 86 that come from patient temperature probe 88, controller uses one or more assumed patient temperatures. The assumed patient temperatures are used by controller 46 in loop 70b in the same manner as the actual measured patient temperatures 86 are used in loop 70b. That is, controller 46 compares the patient target temperature to the assumed patient temperature and determines the difference, if any. This difference is then forwarded to the proportional, derivative, and integral channels of control loop 70a where it is processed in the manners described above with respect to steps 90, 92, and 94. After steps 90, 92, and 94, the outputs from these steps are summed together to determine a fluid target temperature, and the fluid target temperature is input into control loop 70a.
Controller 46 utilizes one or more assumed patient temperature readings after pause/event control 66b is activated because pause/event control 66b is intended to be activated when a patient is given medication, has fluid applied to the situs of patient temperature probe 88 for cleaning (or other) purposes, or experiences some other type of treatment that affects the temperature readings of patient temperature probe 88. For example, in many cases it is customary to use a patient temperature probe 88 that is positioned in a patient's esophagus. Medication, however, may also be delivered to a patient via his or her esophagus during thermal treatment of the patient, or the esophagus and/or the temperature probe 88 may be rinsed with fluid during thermal treatment of the patient. When such medication and/or other fluids are given to the patient, they are typically not at the same temperature of the patient. In some cases, they may be at room temperature, or they may be refrigerated, or in some cases heated.
As a result, when the fluid or medication is administered to the patient at a location adjacent to the patient temperature probe 88, the patient temperature probe begins reporting patient temperatures that are no longer an accurate reflection of the patient's actual temperature. This is because the administered fluid or medication comes into physical contact with the patient temperature probe 88 and the probe begins reporting temperatures of the fluid and/or medication, or temperatures that are a combination of the patient's temperature mixed with the fluid and/or medication's temperature. In the absence of the activation of pause/event control 66b, these inaccurate patient temperature readings cause controller 46 to change its thermal control of the fluid circulating in circulation channel 34. However, this change in thermal control is based on inaccurate temperature information and can interrupt and/or delay the thermal treatment of the patient.
An example of the possible effects of thermal contact between patient temperature probe 88 and medication or fluid administered to the patient can be seen more clearly in FIG. 5. FIG. 5 shows a graph 96 illustrating fluid temperature 72, patient temperature 86, and a patient target temperature 84 over time. As shown therein, the patient target temperature 84 is a constant value (typically set by a user using user interface 64). When the thermal therapy treatment shown in FIG. 5 begins, the fluid temperature is initially warmer than the patient target temperature 84, but cooler than the patient's measured temperature 86. Once the thermal treatment begins, controller 46 begins cooling the fluid temperature using control loops 70b and 70a. The cooling of the circulating fluid continues until, in the illustrated embodiment, the fluid reaches a predetermined minimum temperature 98 below which thermal control unit 22 does not lower the temperature of the circulating fluid. Minimum temperature 98 is designed as a safety temperature and may vary. In some embodiments, it may be set to about four degrees Celsius, although other temperatures may be selected. In some embodiments, controller 46 may also implement a predetermined maximum temperature 100 above which it does not heat the circulating fluid. The predetermined maximum is also implemented as a safety measure and may be set to about forty degrees Celsius, although other values may be selected.
As seen in FIG. 5, the result of the circulating fluid being cooler than the patient's temperature, as well as the cooling of the fluid's temperature by controller 46, the patient's temperature 86 begins to drop toward target temperature 84. At an arbitrary time TE1 shown therein, a first event takes place. The precise nature of the first event may vary, but it includes the administration of medication and/or fluid to the patient at a location common to the location of patient temperature probe 88. Specifically, in the example shown in FIG. 5, the first event includes the administration of fluid or medication that has a temperature cooler than the patient's temperature. This causes the cooler fluid/medication to come into contact with the probe 88 and, as a result, the patient temperature readings 86 begin to show a sharp drop starting at time TE1. These dropped temperature readings continue until time TE2. TE2 is the time at which the thermal effects of the administered medication and/or fluid have worn off. That is, TE2 reflects the time when patient temperature probe 88 is once again reporting accurate indications of the patient's temperature (as opposed to temperature readings influenced by the temperature of the administered fluid or medication).
If pause/event control 66b is not activated by a user at or near the time of event TE1, FIG. 5 illustrates via a dashed line 102 what would otherwise occur with respect to the fluid temperature 72. Specifically, dashed line 102 shows that controller 46 would warm the circulating fluid in response to the relatively sharp drop in the temperature readings from patient temperature probe 88 caused by the administration of the cooler medication and/or fluid. This is because the sharp drop in reported temperature readings 86 would causes controller 46 to start warming the circulating fluid in anticipation of the patient's temperature reaching target 84. This warming of the fluid temperature would continue until temperature readings reported by patient temperature probe 88 bottomed out at point A. After bottoming out at point A, the increase in the reported patient temperature readings would cause controller 46 to once again start cooling the circulating fluid. However, due to the thermal inertia of the system, the circulating fluid's temperature would likely not immediately decrease, but would instead likely start to decrease only after some time had passed subsequent to the patient's temperature bottoming out.
The result of the delivery of medication and/or fluid to the patient at a temperature different from the patient's temperature therefore causes controller 46, in the absence of the activation of pause/event control 66b, to make adjustments to the fluid temperature that are based on inaccurate readings of the patient's actual temperature. This not only causes thermal control unit 22 to waste energy, but it can slow down the speed at which thermal control unit 22 brings a patient to the target patient temperature 84. In the example of FIG. 5, this delay is caused by the fact that controller 46 has warmed the temperature of the fluid in response to what was perceived as a sharp drop in the patient's actual temperature, but was in fact a sharp drop in temperature due to the coldness of the administered fluid or medication and its cooling effect on patient temperature probe 88. Had the medication and/or fluid not been administered, controller 46 would not have warmed the fluid and the patient would have been cooled toward target temperature 84 more quickly.
The activation of pause/event control 66b allows controller 46 to substantially eliminate the delay caused by inaccurate patient temperature probe readings. When a user activates pause/event control 66b, controller 46 pauses using actual readings from patient temperature probe 88 in control loop 70b and instead uses assumed readings. The assumed readings, in some embodiments, are generated by predicting the patient's temperature. In other embodiments, the assumed readings are inferred from other factors and/or sensor readings that do not measure the patient's core temperature directly (e.g. the amount of heat transferred to/from the patient may be used to infer a patient temperature, either alone or in combination with a weight, a BMI reading, or another measurement of the patient's size). Further, in at least one embodiment where predicted patient temperature readings are used, the predicted patient temperature readings are based on a trend in the past patient temperature readings in the moments prior to the activation of pause/event control 66b. This is more easily understood with respect to FIG. 6.
FIG. 6 shows an enlargement of the patient temperature readings 86 of FIG. 5 around the times between TE1 and TE2. As seen therein, FIG. 6 shows the actual patient temperature readings 86 prior to TE1 as generally decreasing. At the time of TE1, the reported patient temperature readings from patient temperature probe 88 begin to drop due to the administration of cold fluid or medication. As noted, these patient temperature readings are inaccurate because of the cold fluid or medication. These inaccurate patient temperature readings are indicated in FIG. 6 by the dashed line 86a. At the moment of TE1, controller 46 calculates a set of predicted patient temperature values that are indicated in FIG. 6 by dashed line 86b. The predicted patient temperature readings 86b may be predicted in a variety of different ways. In one example, the slope of the actual patient temperature readings 86 in the moments prior to TE1 is determined and a line with the same slope is extended forward from the patient temperature reading at time TE1. In other words, the predicted temperature readings may simply be a linear extension of the rate at which the patient's temperature was dropping in the moments near TE1. Other more sophisticated prediction techniques may be used, including, but not limited to, ones that examine not only the slope of the patient temperature readings 86 in the moments before TE1, but also one or more derivatives of the slope, and/or other factors.
Regardless of the specific method used to predict the patient's temperature values 86b, controller 46 uses the predicted temperature values 86b with control loop 70b in response to the user activating pause/event control 66b. The use of predicted temperature values 86b with control loop 70b continues for a predefined amount of time. This predefined amount of time is intended by controller 46 to be equal to time TE2, which, as noted, is the amount of time it takes until the thermal effects of the contact between the temperature probe 88 and the medication and/or fluid have worn off. Controller 46 determines this predefined amount of time in either of two manners. In a first manner (T′E2), the predefined amount of time lasts until the inaccurate readings 86a from patient temperature probe 88 return to within a threshold range 104 of the predicted patient temperature values 86b. In a second manner (T″E2), the predefined amount of time lasts until a fixed amount of time 106 passes from TE1. Either of these manners, as well as still others, may be used for determining when the predefined time period ends.
Regardless of which specific method is used to determine the end of the predefined time period TE2, controller 46 switches back to using the patient temperature readings 86 from patient temperature probe 88 in control loop 70b when the predefined time period ends. In other words, at time TE2, controller 46 concludes that the readings from patient temperature probe 88 are no longer inaccurate (readings 86a), and therefore starts to use them again as inputs into control loop 70b. Thus, in the example shown in FIG. 6, controller 46 uses readings 86 in control loop 70b until time TE1. After time TE1, controller 46 uses predicted readings 86b in control loop 70b until the predefined time period expires. Depending on how the predefined time period is defined, controller 46 therefore uses predicted readings 86b from TE1 to either T′E2 or T″E2. After that, controller 46 resumes using the readings 86 received from patient temperature probe 88.
The result of using the predicted temperature readings 86b during the predefined time period instead of the actual, but inaccurate, readings 86a is that controller 46 substantially ignores the changes in the temperatures reported from probe 88 that are caused by the different temperature of the administered fluid or medication. Although the predicted temperatures 86b that are used during this predefined time period may not accurately reflect the patient's actual temperature during this time period, they are a better reflection of the patient's actual temperature than the temperature readings reported by probe 88. Consequently, the actions carried out by controller 46 in controlling the temperature of the circulating fluid during this predefined time period are more responsive to the actual patient's temperature, and this more accurate response reduces delays that would otherwise likely occur in bringing the patient to the desired temperature, reduces energy that would otherwise likely be wasted, and/or helps thermal control unit 22 more smoothly maintain a patient's temperature at the desired temperature.
Although FIG. 6 illustrates an example of fluid or medication being administered to a patient that has a colder temperature than the patient's temperature, it will be understood that the same principles can be applied when fluid or medication is administered to the patient that is warmer than the patient's temperature. Further, it will also be understood that the pause/event control 66b is only desirably activated by a user when medication or fluid is administered to a patient at a location where the medication or fluid will affect the temperature readings reported by patient temperature probe 88. Thus, for example, if patient temperature probe 88 is a rectal probe and cold or warm medicine is administered to the patient via the esophagus, there is no need to activate pause/event control 66b in response to this medicine administration because the rectal probe will not come in contact with the administered medicine.
Although pause/event control 66b has been described herein as pausing the use of patient temperature readings 86a during a predefined time period, it will be understood by those skilled in the art that thermal control unit 22 may be modified to allow a user to change the predefined time period. For example, user interface 64 may be modified in some embodiments to allow a user to shorten or lengthen the predefined time period. This user-adjustability may be useful in situations where the user does not immediately activate control 66b after administering the fluid or medication. If the user happens to be delayed for a few minutes after administering fluid or medication to the patient before he or she activates control 66b, the user may wish to shorten the predefined time period to accommodate for the delay in activating control 66b. In some instances, the user is able to specify the new length of the predefined time period, while in other instances, the user is able to input the actual time at which medicine or fluid was administered. In the latter case, controller 46 may be configured to use the actual time entered when generating the predicted patient temperature readings 86b. That is, controller 46 may be configured to use only those readings from probe 88 that occurred before the entered time when predicting temperatures 86b in recognition that the readings from probe 88 that occurred after the entered time are likely inaccurate measurements of the patient's temperature.
FIG. 5 also illustrates the fact that pause/event control 66b can be activated multiple times during the course of a patient's thermal therapy. Specifically, FIG. 5 shows a second event occurring at time TE3. The second event refers to the administering of medication and/or fluid to the patient for a second time. If the user does not activate pause/event control 66b at time or near time TE3, controller 46 will likely control heat exchanger 38 in a manner that causes the fluid temperature to rise in the manner shown by the second dotted line 102. However, if the user does activate pause/event control 66b at or near time TE3, controller 46 will generate a set of predicted patient temperatures 86b and use those predicted patient temperatures in control loop 70b until time TE4 is reached. Time TE4 may be defined in any of the same manners as time TE2. That is, it may be a fixed amount of time 106 after time TE3, it may be a variable amount of time that lasts until the readings from patient temperature probe 88 return to within a threshold range 104 of the predicted readings 86b, or it may be defined in a different manner.
In some embodiments, controller 46 is configured to issue an alarm if the patient's temperature changes by more than a predefined criterion, such as at a rate greater than a predefined limit. The purpose of the alarm is to ensure patient safety and to prompt users of thermal control unit 22 to investigate whether the reported steep change in the patient's temperature is actual, or caused by something other than the patient's actual temperature. In some instances, the rate of temperature change that prompts this alarm is set such that the alarm may be triggered when medication or fluid is administered to the patient at a location adjacent patient temperature probe 88. This is because the different temperature of the fluid or medication causes the temperature readings reported by the probe 88 to shift suddenly.
In order to avoid this alarm, controller 46 is configured in some embodiments to automatically suppress this patient temperature alarm whenever pause/event control 66b is activated. The suppression of this patient temperature alarm continues, in some embodiments, for the same amount of time that controller 46 uses assumed patient temperature readings 86b. That is, in some embodiments, it continues for the time from TE1 to TE2. In other embodiments, the time period of the suppressed patient temperature alarm is different.
Still further, in some embodiments, rather than suppressing completely the alarm indicating an excessive rate of change in the patient's temperature, controller 46 is configured to use a different threshold for alarming during the time period between TE1 and TE2. For example, if controller 46 is configured to issue an alarm if the patient's temperature changes by more than X degrees per minute when control 66b is not activated, controller 46 may be configured to only issue the alarm after control 66b is activated if the patient's temperature (as reported by probe 88) changes by more than Y degrees per minute, where Y is a higher number than X. The switching of the alarm threshold is temporary and, as noted, may continue for the same amount of time as the predefined time period discussed above, or it may continue for a different amount of time.
In other embodiments, a control separate from control 66 may be included on user interface 64 that temporarily suppresses and/or changes the criteria for the patient temperature alarm. In such embodiments, the user is able to utilize the alarm suppression option (or threshold change option) independently from the pause/event control 66b. In other words, pause/event control 66b can be activated by itself, the alarm suppression can be activated by itself, or they can both be activated together. In any embodiment, the alarm suppression may be complete, or it may be partial (e.g. a reduced volume, issued only locally and not remotely, etc.)
FIG. 7 shows another graph 108 illustrating another feature of thermal control unit 22. The graph includes an example of a patient's temperature 86, the fluid temperature 72 of the circulating fluid inside thermal control unit 22, and the target temperature 84 of a patient undergoing thermal treatment when thermal control unit 22 is operating in the automatic mode. Graph 108 differs from graph 96 of FIG. 5 in that FIG. 5 illustrates how thermal control system 20 responds when pause/event control 66b is activated while FIG. 7 illustrates how thermal control system 20 responds when medication control 66c is activated. Medication control 66c is activated after a patient is treated with certain types of medication, as will be explained in more detail below.
Medication control 66c is activated in order to allow thermal control unit 22 to better account for the pharmacological effects of patient medication on the thermal treatment of the patient. This differs from pause/event control 66b, which is activated in order to better account for the physical effects of the medication's temperature (or the fluid's temperature) on patient temperature probe 88. In other words, control 66b addresses how medication at a different temperature than patient temperature probe 88 affects the readings from patient temperature probe 88 when the medication comes into physical contact with patient temperature probe 88, while control 66c addresses how the medication (regardless of its temperature and the physical location at which it is administered) affects the patient's thermal physiology.
It is known that certain types of medication administered to a patient change the patient's responsiveness to thermal therapy. For example, if a patient is being cooled by thermal control unit 22 and is given a sedative, the sedative will typically allow thermal control unit 22 to reduce the patient's temperature more quickly than it otherwise would do so in the absence the sedative. Similarly, if a patient is given a paralytic medication to help prevent or stop patient shivering, the paralytic will typically cause the patient's temperature to drop more quickly than it would in the absence of the paralytic.
Medication control 66c is activated by a user when medicine is given to the patient that will have an effect on the patient's temperature, such as, but not limited to, a sedative or paralytic. When activated, controller 46 is adapted to adjust its control of the temperature of the circulating fluid in a manner that is more responsive to the likely effects of the medication and that helps prevent overshoot of the patient's temperature. Overshoot refers to the excessive warming or cooling of a patient after the patient's target temperature 84 is reached. Thus, for example, if a patient is cooled one degree below the target temperature 84, the cooling overshoot is one degree. To rectify this, thermal control unit 22 thereafter attempts to warm the patient back up the one degree to target temperature 84. However, if the patient warms up past target temperature 84, there is a warming overshoot.
Controller 46 is programmed to respond to the activation of medication control 66c, in some embodiments, in different manners, depending upon the different medication or different types of medications administered to the patient. In such embodiments, user interface 64 may be configured to request that a caregiver enter the name of the medication administered to the patient and/or the type of medication administered. In some such embodiments, user interface 64 may be programmed to also request an amount of the medication administered, and/or other information that affects the likely thermal response of the patient to the medication, such as, but not limited to, the weight of the patient, the body mass index of the patient, and/or other factors. In some embodiments, the thermal control unit 22 includes a bar code scanner, or the like, that automatically reads a bar code or other information from the label of a medication in order to determine the type of medication, amount of medication, and/or other information about the medication. In such latter embodiments, the thermal control unit 22 may be modified such that the reading of information from a medication label via the bar code scanner, or the like, automatically activated medication control 66c, thereby relieving the caregiver of the task of manually activating this control.
Controller 46 is programmed to use the information input by a caregiver when control 66c is activated in order to adjust the cooling or heating of the circulating fluid in a manner that anticipates the likely effect of the administered medication on the patient. One example of this programming is shown in more detail in FIG. 7. At a time TE5, a sedative is administered to a patient undergoing thermal treatment using thermal control unit 22. The sedative is predicted by controller 46 to drop the patient's temperature more precipitously than it would in the absence of the sedative.
In at least one embodiment, in order to better prevent and/or reduce any overshoot in the patient's temperature, controller 46 determines at time TE5 the current difference between the patient's temperature and the target temperature and the rate of change of this difference. Controller 46 uses this difference and its rate of change to determine a likely rate and/or temperature path that the patient will follow in reaching the target temperature 84, in the absence of the sedative, were controller 46 to continue to control heat exchanger 38 using control loops 70a and 70b. This path 86c is illustrated in dashed lines in FIG. 7. Controller 46 thereafter repetitively compares the patient's actual temperature to the predicted temperature and determines if the patient's temperature is dropping at an accelerated rate due to the medication. If it is, controller 46 warms the circulating fluid sooner than it otherwise would. If it is not, controller 46 stops or reduces the warming, such as shown by temperature line 72a in FIG. 7.
In some embodiments, controller 46 calculates a predicted effect of the sedative on the patient's temperature and determines how much earlier the patient will likely reach the target temperature due to the pharmacological effect of the sedative. The predicted pharmacological effect is determined using one or more of the following: previous administrations of the sedative on prior patients who were treated using thermal control unit 22 and whose data is stored in an accessible memory by controller 46, previously gathered data of the effects of the sedative from other thermal control units and/or from published literature, or other techniques. Thereafter, controller 46 adjusts the commands sent to heat exchanger 38 in order to anticipate the earlier arrival of the patient at the target temperature. As shown in FIG. 7, the earlier expected arrival of the patient at the target temperature causes controller 46 to begin warming the circulating fluid sooner than it otherwise would. Specifically, at or shortly after TE5, controller 46 begins warming the circulating fluid, as shown by the upward rise in fluid temperature 72. At an evaluation point TE6, controller 46 evaluates the drop in the patient's temperature. If the drop is consistent with the predicted drop caused by the sedative, controller 46 continues to warm the circulating fluid, as shown by solid line 72. However, if the patient's temperature has dropped less than predicted, controller 46 returns to cooling the patient in a manner indicated by dashed line 72a.
Dashed line 72a may reflect fluid temperatures resulting from controller 46 cooling the circulating fluid as if no sedative had been administered, or it may reflect fluid temperatures resulting from controller 46 cooling the circulating fluid as if the sedative had been administered but with reduced effect. In other words, dashed line 72a may represent controller 46 cooling the circulating fluid using a revised predicted effect of the sedative on the patient's temperature wherein the revised predicted effect is less than the original predicted effect. At a subsequent time, controller 46 may then compare the patient's actual temperature to that predicted using the revised predicted effect, and if the revised predicted effect and actual temperature vary by more than a threshold, make further revisions to revised predicted effect
In another embodiment, controller 46 is programmed to adjust the derivative coefficient KD and/or the error values (TP) used in the derivative step 92 of control loop 70b in response to the administration of a medication, such as a sedative. The adjustments use values that anticipate a greater negative slope in the patient's temperature (i.e. a more precipitous drop in the patient's temperature than would otherwise occur). The result is that controller 46 anticipates the pharmacological effect of the medication on the patient's temperature and makes adjustments to the temperature of the circulating fluid sooner than would otherwise occur. This helps to reduce overshoot in the patient's temperature.
The overall result of the reaction of controller 46 to the administration of a sedative, or other medication, to the patient is such that, when the patient's temperature reaches the target patient temperature at time TE7, the temperature of the fluid 72 is also close to the target temperature, and there is no delay in waiting for heat exchanger 38 to heat up the circulating fluid to a value close to the patient target temperature. By having the circulating fluid temperature 72 near the patient target temperature 84 at or near the moment the patient reaches this target temperature, the probability of overshoot and/or the extent of any overshoot is greatly reduced. Further, because controller 46 has accounted for the increased cooling effect of the medication on the patient's temperature, there is also no delay in reducing the patient's temperature to the target temperature 84. The result therefore achieves reduced overshoot without any slowdown in the rate at which the patient's temperature is brought to the target temperature 84.
It will be understood by those skilled in the art that controller 46, when predicting the effect of a medication on a patient, may use not only the trend of previously measured patient temperatures prior to the administration of the medication, but also multiple additional pieces of information. These multiple additional pieces of information include data from prior clinical studies of specific medications and/or types of medications, published data for particular medications, patient data (e.g. height, weight, BMI, etc.) previously stored patient temperature data gathered by thermal control unit 22 from previous thermal treatments and stored in a memory of thermal control unit 22, and/or other sources.
Thermal control unit 22 may also be configured to implement an automatic temperature adjustment feature that automatically adjusts the patient target temperature based upon an administered medication. Some medications are desirably administered to a patient when the patient, or a portion of the patient's body where the medication is administered, is at a specific temperature. In order to implement this feature, user interface 64 may be modified to include another control 66d that, when activated, informs controller 46 that a medication has been administered to the patient that has a target temperature associated with it. Control 66d includes, in some embodiments, the ability for a user to identify the specific medication administered to the patient. In response to the activation of control 66d, controller 46 accesses a memory on board thermal control unit 22 that stores desired temperatures for particular medications. Controller 46 uses this memory to look up the desired patient temperature corresponding to the particular medication identified by the user as having been administered to the patient. Controller 46 then resets the patient target temperature 84 to the desired temperature corresponding to the administered medication. The new patient target temperature 84 is thereafter used by control loop 70b so that the patient's temperature is adjusted by thermal control unit 22 toward the new patient target temperature.
In some embodiments, controller 46 is programmed to respond to control 66d by changing the patient target temperature for only a predetermined amount of time. The predetermined time may correspond to the amount of time the patient's temperature is held at the new target temperature in order for the medication to be most effective. In other words, if medication A is desirably administered to a patient whose temperature stays at 35 degrees Celsius for four hours, then controller 46 automatically switches the target patient temperature back to its previous value after the passage of four hours. The particular times at which a patient's temperature is held at a new desired target temperature may be stored in the same memory that stores the target temperatures themselves. These values may be taken from published literature and/or from recommendations from the manufacturer of the individual medications. Alternatively, the automatic temperature adjustment feature of control 66d may be configured to allow a user to specify the length of the predetermined amount of time.
In some embodiments, thermal control unit 22 is adapted to deliver fluid at different temperatures to different thermal pads 24. For example, thermal control unit 22 is adapted, in some embodiments, to be able to deliver fluid at temperature X to a first outlet port 44 and fluid at temperature Y to a second (or third) fluid outlet port 44. The different fluid outlet ports 44 are in fluid communication with thermal pads 24 that are positioned at different locations on the patient's body. In some situations, one or two thermal pads 24 are positioned on the patient's legs while another is wrapped around the patient's torso. In such embodiments, thermal control unit 22 is adapted to adjust the patient target temperatures 84 for the different portions of the patient's body independently. That is, the temperature controlled fluid delivered to the patient's legs may have a different temperature than the temperature controlled fluid delivered to the patient's torso. Alternatively, it may be desirable in some situations to deliver fluid of different temperature to the patient's legs. In still other embodiments, the thermal pads 24 may be positioned at other locations on the patient's body, and fluid of different temperature may be delivered to the different body parts.
In at least one embodiment of thermal control unit 22 that is configured to deliver fluid at multiple temperatures, controller 46 is adapted to automatically alter the patient target temperature for a particular portion of the patient's body in response to the activation of control 66d. Thus, for example, if a patient is undergoing thermal treatment with thermal control unit 22 and a medication is applied to a local portion of the patient's body, e.g. to the patient's right leg, controller 46 is programmed—in response to activation of control 66d—to alter the patient target temperature for the patient's right leg while leaving the patient's target temperature for the rest of the patient's body unadjusted. In this manner, thermal control unit 22 automatically adapts to the administration of particular medications to a local area of the patient's body by adjusting the patient's temperature in that particular local area to a target temperature that is desirable for the administered medication. Control 66d can therefore be used to either automatically adjust the target temperature of the patient's entire body, or only a portion of the patient's body, in response to the administration of medication.
It will be understood that although thermal control unit 22 has been described herein as having all four controls 66a, 66b, 66c, and 66d, thermal control unit 22 can be modified to include fewer of these controls. Indeed, thermal control unit 22 can be modified to include control 66a in combination with any one or more of controls 66b, 66c, and/or 66d. In some embodiments, the controls 66a-d are incorporated into thermal control unit 22 in such a way that each control operates separately and independently from the other control. However, in some embodiments, the functions of more than one of the controls may be combined together. For example, in one modified embodiment, if a user activates both pause/event control 66b and medication control 66c, controller 46 is programmed to use predicted values of the patient's temperature 86b in control loop 70b wherein the predicted values take into account the pharmacological effect of the medication administered to the patient (based on experimental data previously gathered and stored in an accessible memory). As a result, controller 46 will use a different set of predicted patient temperature values than it would otherwise use if only control 66b were activated (and not control 66c). Still other types of overlap in functions may be implemented when more than one control 66 is activated.
It will be understood that thermal control unit 22 can be modified from what has been shown and described herein in a variety of other manners. For example, thermal control unit 22 may also be modified to include one or more flow sensors that measure the rate of fluid flow and report this information to controller 46. In such modified embodiments, controller 46 uses the flow rate in determining what heating/cooling commands to send to heat exchanger 38 and/or what flow rate signals to send to pump 32.
The particular order of the components along circulation channel 34 of control unit 22 may also or alternatively be varied from what is shown in FIG. 3. For example, although FIG. 3 depicts pump 32 as being upstream of heat exchanger 38 and air separator 58 as being upstream of pump 32, this order may be changed. Air separator 58, pump 32, heat exchanger 38 and reservoir 62 may be positioned at any suitable location along circulation channel 34. Indeed, in some embodiments, reservoir 62 is moved so as to be in line with and part of circulation channel 34, rather than external to circulation channel 34 as shown in FIG. 3, thereby forcing the circulating fluid to flow through reservoir 62 rather than around reservoir 62.
Further details regarding the construction and operation of one embodiment of thermal control unit 22 that are not described herein are found in commonly assigned U.S. patent application Ser. No. 14/282,383 filed May 20, 2014, by inventors Christopher Hopper et al. and entitled THERMAL CONTROL SYSTEM, the complete disclosure of which is incorporated herein by reference.
User interface 64 of thermal control unit 22 can take on a wide variety of different forms. For example, although pause/event control 66b has been described herein primarily as a dual-function control in which the use of temperature probe readings is paused and event information is entered, it will be understood that these functions can be separated. For example, in at least one embodiment, pause/event control 66b is replaced with an event control 66b that, when activated, allows a caregiver to enter event information (such as the use of cleaning fluid at the site of the temperature probe 88 or the administration of medication at that site, etc.). Further, when this event information is entered, controller 46 automatically activates the pause function. As yet another alternative, controls two or more of controls 66b, 66c, and 66d can be combined into a single control that, when activated, prompts the user to input further information about the event taking place. Controller 46 then either automatically activates the appropriate function associated with one of controls 66b-d based on the entered event data, or presents on a touch screen display an option for the caregiver to activate the desired control. Still other variations may be implemented for activating one or more of the controls 66b-d.
User interface 64 may also be modified to allow a user to enter event data indicating that patient temperature probe 88 is being temporarily removed or readjusted. For example, probe 88 may be removed for cleaning purposes, or it may be removed in order to provide clearance for a medical procedure and/or to administer medication, and/or for other purposes. In such situations, the readings from probe 88 while it is positioned outside the patient's body, or while it is being cleaned, or while it is otherwise being adjusted, will likely not be accurate. User interface 64 may therefore be modified to include an additional control (e.g. 66e, not shown) for such situations, or control 66b can be modified such that, when activated, a user can identify this particular event to controller 46. In such events, controller 46 is programmed to act in the same manner as when control 66b is activated, except instead of acting in this manner for a predefined amount of time, controller 46 acts in this manner until the user indicates via user interface 64 that the probe 88 has been returned to the patient, the cleaning of probe 88 is done, or whatever the event was that led to the inaccurate temperature readings from probe 88 is otherwise completed. Thermal control unit 22 can therefore be modified to both start and stop using assumed temperature readings based on manual inputs from the user (in addition to automatically starting and/or stopping the use of assumed temperatures). Still other modifications are possible.
Various additional alterations and changes beyond those already mentioned herein can be made to the above-described embodiments. This disclosure is presented for illustrative purposes and should not be interpreted as an exhaustive description of all embodiments or to limit the scope of the claims to the specific elements illustrated or described in connection with these embodiments. For example, and without limitation, any individual element(s) of the described embodiments may be replaced by alternative elements that provide substantially similar functionality or otherwise provide adequate operation. This includes, for example, presently known alternative elements, such as those that might be currently known to one skilled in the art, and alternative elements that may be developed in the future, such as those that one skilled in the art might, upon development, recognize as an alternative. Any reference to claim elements in the singular, for example, using the articles “a,” “an,” “the” or “said,” is not to be construed as limiting the element to the singular.
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16169271
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stryker corporation
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USA
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B2
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Utility Patent Grant (with pre-grant publication) issued on or after January 2, 2001.
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Open
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Apr 27th, 2022 09:01AM
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Apr 27th, 2022 09:01AM
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Stryker
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Health Care
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Health Care Equipment & Services
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nyse:syk
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Stryker
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Apr 26th, 2022 12:00AM
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Dec 17th, 2020 12:00AM
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https://www.uspto.gov?id=US11311431-20220426
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Adjuster for use with flexible restraints
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A harness system includes one or more harness assemblies. Each harness assembly includes a flexible restraint formed of a coated fabric. An adjuster is provided to adjust an effective length of the flexible restraint. The adjuster includes a frame, a restraint guide, and a cam.
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11311431
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1. An adjuster for use with a flexible restraint, the adjuster comprising:
a frame defining an opening and having a clamping surface;
a restraint guide comprising a roller arranged for frictional engagement with the flexible restraint, the roller being rotatably supported by a pin coupled to the frame and positioned relative to the opening so that the flexible restraint is capable of being routed over the clamping surface, wrapped about the roller, and passed through the opening; and
a cam rotatably coupled to the frame about a rotational axis and comprising a lever portion arranged to be actuated by a user and a clamping portion arranged to clamp the flexible restraint against the clamping surface, the cam being rotatable to a plurality of clamping positions,
wherein the clamping portion defines a cam profile in cross-section that has a spiral shape, the cam profile having clamping points, each of the clamping points defined as a nearest point on the cam profile to the clamping surface at each of the plurality of clamping positions,
wherein the cam defines a fixed plane passing through the rotational axis normal to the clamping surface, and the cam defines a clamping plane parallel to the clamping surface passing through each of the clamping points, wherein each of the clamping points are offset from the fixed plane by a first distance and the clamping plane is offset from the rotational axis by a second distance, with a ratio of the second distance to the first distance being in a range of from 2.5 to 5.5 for each of the clamping positions.
2. The adjuster of claim 1, wherein the ratio of the second distance to the first distance is in a range of from 3.0 to 4.0 for each of the clamping positions.
3. The adjuster of claim 2, wherein the first distance is from 0.05 inches to 0.1 inches and the second distance is from 0.15 inches to 0.4 inches.
4. The adjuster of claim 1, wherein the clamping portion has teeth extending to tips that define the cam profile and each of the teeth has a generally triangular shape and is symmetrical about a midline disposed normal to the cam profile.
5. The adjuster of claim 1, wherein the roller comprises a plurality of rolling segments each rotatably supported by the pin.
6. The adjuster of claim 1, wherein the frame comprises a brake configured to be spaced from the roller in normal operation and to contact the roller upon bending of the restraint guide to brake rotation of the roller.
7. The adjuster of claim 6, wherein the frame comprises a wall and the brake comprises a flanged portion of the wall.
8. The adjuster of claim 1, comprising a biasing device arranged to act between the frame and the cam to bias the cam toward the plurality of clamping positions.
9. The adjuster of claim 8, comprising a spring-supporting pin coupled to the frame, wherein the biasing device comprises a dual spring having coils disposed about the spring-supporting pin and a U-shaped spring end located to bias against the lever portion of the cam.
10. The adjuster of claim 8, wherein the biasing device comprises a spring having opposing ends and the cam defines a spring through hole to receive the spring such that the ends of the spring extend from the cam on opposing sides of the cam to engage the frame.
11. The adjuster of claim 8, wherein the biasing device comprises a spring and the cam has a first side with a first pocket to receive the spring and the cam has a second side, opposite the first side, the second side having a second pocket.
12. The adjuster of claim 11, comprising a stop coupled to the frame, wherein the stop extends into the second pocket, the cam having an abutment arranged to engage the stop upon rotation of the cam by the user from one of the clamping positions to a releasing position.
13. The adjuster of claim 12, comprising a pin supporting rotation of the cam, wherein the frame comprises a first wall and a side wall extending from the first wall, the stop comprising a collar disposed about the pin and a protrusion extending from the collar, through the side wall, and into the second pocket.
14. The adjuster of claim 13, wherein the pin has a head and a shaft extending from the head and the collar defines an opening for receiving the head, the head and opening shaped to prevent relative rotation between the pin and the collar.
15. An adjuster for use with a flexible restraint, the adjuster comprising:
a frame defining an opening and having a clamping surface;
a cam rotatably coupled to the frame and comprising a lever portion arranged to be actuated by a user and a clamping portion arranged to clamp the flexible restraint against the clamping surface; and
a restraint guide comprising a roller rotatably coupled to the frame and positioned relative to the opening so that the flexible restraint is capable of being routed over the clamping surface, wrapped about the roller, and passed through the opening,
wherein the frame comprises a brake configured to be spaced from the roller in normal operation and to contact the roller upon bending of the restraint guide to brake rotation of the roller.
16. The adjuster of claim 15, wherein the frame comprises a wall and the brake comprises a flanged portion of the wall.
17. An adjuster for use with a flexible restraint, the adjuster comprising:
a frame defining an opening and having a clamping surface;
a restraint guide coupled to the frame and positioned relative to the opening so that the flexible restraint is capable of being routed over the clamping surface, wrapped about the restraint guide, and passed through the opening;
a cam rotatably coupled to the frame and comprising a lever portion arranged to be actuated by a user and a clamping portion arranged to clamp the flexible restraint against the clamping surface, the cam being rotatable to a plurality of clamping positions;
a biasing device arranged to act between the frame and the cam to bias the cam toward the plurality of clamping positions; and
a stop coupled to the frame and arranged to engage the cam upon rotation of the cam by the user from one of the clamping positions to a releasing position.
18. The adjuster of claim 17, comprising a pin supporting rotation of the cam, wherein the frame comprises a first wall and a side wall extending from the first wall, the stop comprising a collar disposed about the pin and a protrusion extending from the collar, through the side wall.
19. The adjuster of claim 18, wherein the pin has a head and a shaft extending from the head and the collar defines an opening for receiving the head, the head and opening shaped to prevent relative rotation between the pin and the collar.
20. The adjuster of claim 18, wherein the cam defines a pocket receiving the stop and an abutment for engaging the stop upon rotation of the cam to the releasing position, the pocket sized to allow the stop to travel in the pocket as the cam moves to the plurality of clamping positions.
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20
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CROSS-REFERENCE TO RELATED APPLICATION
The subject patent application is a Continuation of U.S. patent application Ser. No. 16/281,729, filed on Feb. 21, 2019, the disclosure of which is hereby incorporated by reference in its entirety.
BACKGROUND
Patient transport apparatuses comprise, for example, hospital beds, stretchers, cots, wheelchairs, and chairs. A conventional patient transport apparatus comprises a support structure having a base, a support frame, and a patient support surface upon which the patient is supported.
In some cases, a patient transport apparatus is needed to transport a patient to a hospital or other emergency medical facility in an emergency vehicle. During transport, it is desirable for the patient to be securely restrained to the patient transport apparatus. A harness system may be used to secure the patient to the patient transport apparatus. The harness system typically comprises one or more harness assemblies having flexible restraints. Adjusters are employed to adjust an effective length of the flexible restraints.
SUMMARY
The present disclosure provides an adjuster for use with a flexible restraint. The adjuster includes a frame defining an opening and having a clamping surface. A restraint guide is coupled to the frame and is positioned relative to the opening so that the flexible restraint is capable of being routed over the clamping surface, wrapped about the restraint guide, and passed through the opening. A cam is rotatably coupled to the frame about a rotational axis, has a lever portion arranged to be actuated by a user and a clamping portion arranged to clamp the flexible restraint against the clamping surface, and is rotatable to a plurality of clamping positions. The clamping portion defines a cam profile in cross-section that has a spiral shape. The cam profile has clamping points each defined as a nearest point on the cam profile to the clamping surface at each of the plurality of clamping positions. The cam defines a fixed plane passing through the rotational axis normal to the clamping surface, and defines a clamping plane parallel to the clamping surface passing through each of the clamping points. Each of the clamping points are offset from the fixed plane by a first distance and the clamping plane is offset from the rotational axis by a second distance, with a ratio of the second distance to the first distance being in a range of from 2.5 to 5.5 for each of the clamping positions.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a front view of the patient transport apparatus illustrating a harness system having a plurality of harness assemblies.
FIG. 2A is an illustration of securing a harness assembly to a support frame.
FIG. 2B is an illustration of the harness assembly secured to the support frame.
FIG. 3 is a top perspective view of an adjuster of the harness assembly.
FIG. 4 is a cross-sectional view of the adjuster taken generally along the line 4-4 in FIG. 3.
FIG. 4A is an illustration of bending of a restraint guide of the adjuster.
FIG. 5 is a bottom perspective view of the adjuster.
FIG. 6 is a bottom view of the adjuster.
FIG. 7 is an exploded perspective view of the adjuster.
FIG. 8 is another exploded perspective view of the adjuster.
FIG. 9 is a partial exploded perspective view of the adjuster illustrating a cam and biasing device.
FIG. 10 is a close-up view from FIG. 9 showing a stop for the cam.
FIG. 11 is a left side perspective view of the cam.
FIG. 12 is a right side perspective view of the cam.
FIG. 13 is a rear view of the cam.
FIG. 14 is a close-up view of teeth of the cam and a spiral-shaped cam profile.
FIGS. 15A and 15B are cross-sectional views of the adjuster taken generally along the line 15-15 in FIG. 3 and illustrating movement of the cam to clamp and release, respectively, a flexible restraint.
FIGS. 16A and 16B are cross-sectional views of the adjuster taken generally along the line 16-16 in FIG. 3 and illustrating movement of the cam relative to the stop.
FIG. 17 is an illustration of rotational positions of the cam and clamping points on the cam profile.
FIGS. 18A and 18B illustrate the cam at two different, rotational positions and variables used to evaluate a relationship of the clamping position to clamping force.
FIG. 19 is a table of values for distances (x) and (y) from FIGS. 18A and 18B.
FIG. 20 is a chart illustrating the ratio of y/x relative to delta y.
FIG. 21 is a top perspective view of the adjuster with another biasing device for the cam.
FIG. 22 is a left side view of the biasing device of FIG. 21.
FIG. 23 is a bottom view of the biasing device of FIG. 21.
FIG. 24 is a partial exploded perspective view illustrating another biasing device for the cam.
FIG. 25 is a partial exploded perspective view illustrating a retainer plate for pins of the adjuster.
FIG. 26 is a top perspective view of another adjuster.
FIG. 27 is an exploded perspective view of the adjuster of FIG. 26.
FIG. 28 is a cross-sectional view of the adjuster of FIG. 26 illustrating a knurled bar and roller.
DETAILED DESCRIPTION
Referring to FIGS. 1 and 2A, a patient transport apparatus 30 is shown for supporting a patient. The patient transport apparatus 30 may comprise a hospital bed, stretcher, cot, wheelchair, chair, or similar apparatus utilized in the care of a patient. In the embodiment shown, the patient transport apparatus 30 comprises a cot that is utilized to transport patients in an emergency vehicle (e.g., an ambulance), such as from an emergency site to a hospital or other emergency medical facility. The patient transport apparatus 30 comprises a support structure 32 that provides support for the patient. The support structure 32 comprises a support frame 36. The construction of the support structure 32 may take on any known or conventional design.
A harness system 100 is employed on the patient transport apparatus 30 to secure the patient. The harness system 100 comprises one or more harness assemblies 102-114 that cooperate to secure the patient to the patient transport apparatus 30. For instance, in the embodiment shown in FIG. 1, the harness system 100 comprises shoulder harness assemblies 102, connecting harness assemblies 104, 106 that connect to the shoulder harness assemblies 102 and to each other, thigh harness assemblies 108, 110, and ankle harness assemblies 112, 114.
The harness assemblies 102-114 comprise elongate, flexible restraints 120. In some versions, the flexible restraints 120 comprise coated fabric. The fabric may comprise webbing, such as that formed by woven fabric. The webbing may comprise polyester webbing or other suitable materials. It is also contemplated that the fabric may be formed of nylon webbing, polypropylene webbing, cotton webbing, elastic webbing, and the like. The coated fabric may be like that described in U.S. Pat. No. 10,080,693, entitled, “Harness System for Patient Transport Apparatus,” hereby incorporated herein by reference.
Referring to FIG. 2A, each of the harness assemblies 102-114 is configured to be attached to the support structure 32, but could be attached at any suitable location on the patient transport apparatus 30. In the embodiment shown, each of the harness assemblies 102-114 comprises a connecting loop L that can be utilized to attach the harness assemblies 102-114 to the support structure 32 (only one the harness assemblies 110 is shown in FIG. 2A). For instance, the connecting loop L may be passed through an opening at an anchor location A on the support structure 32 and a remainder of the harness assembly 102-114 can be passed through the connecting loop L to form a secure connection to the patient transport apparatus 30 at the anchor location A.
Referring to FIG. 2B, in some cases, the flexible restraint 120 may comprise two or more layers L1, L2 of fabric attached together to pass through the connecting loop L. The connecting loop L can be a source of a stress riser in the harness assembly 102-114, such as during a crash event, so the additional layer(s) of fabric act to strengthen the flexible restraint 120 at that location. In one version, two layers L1, L2 of coated fabric are adhered together (e.g., via adhesive, heat/RF welding, or ultrasonic welding) to form the connecting loop L. The two layers L1, L2 are connected together along a length of the harness assembly 102-114 so that, when the remainder of the harness assembly 102-114 passes through the connecting loop L, the portion of the harness assembly 102-114 present in the connecting loop L has the at least two layers L1, L2 of coated fabric to distribute loads. In other words, in the version shown, the layers of coated fabric that form the connecting loop L also pass through the connecting loop L when securing the harness assembly 102-114 to the support structure 32.
Adjusters 122 are used to control an effective length of the harness assemblies 102-114. More specifically, each adjuster 122 is arranged to engage the flexible restraint 120 of the harness assemblies 102-114 to adjust an effective length of the flexible restraint 120. The adjuster 122 is configured to control the effective length by being moved by a user relative to the flexible restraint 120 to vary a length of the flexible restraint 120 between the adjuster 122 and an end of the flexible restraint 120 (e.g., by sliding the adjuster 122 along the flexible restraint 120 or by pulling the flexible restraint 120 through the adjuster 122). It should be appreciated that while the harness assemblies 102-114 and adjusters 122 are described herein for use on the patient transport apparatus 30, such harness assemblies 102-114 and adjusters 122 can be used for any other suitable purpose in which a harness assembly and/or adjuster is employed (e.g., backpack harnesses, climbing harnesses, vehicle harnesses, child car seat harnesses, lifting harnesses, load-restraining harnesses, and the like).
In some versions, the adjusters 122 have integrated connectors C1 that comprise male insertion latches (e.g., tongues) configured to be received in connectors C2, such as buckles, for releasably locking to the buckles (similar to seatbelt buckles on vehicles). The connectors C1, C2 may be latches, buckles, catches, carabiners, or other suitable connectors for connecting any two of the harness assemblies 102-114 together. Such connectors are described, for example, in U.S. Pat. No. 10,080,693, entitled, “Harness System for Patient Transport Apparatus,” hereby incorporated herein by reference.
Referring to FIGS. 3-10, each adjuster 122 comprises a frame 124 having a clamping surface 126 and a restraint opening 128 for routing the flexible restraint 120. A cam 130 is spring-biased to rotate relative to the frame 124 to clamp the flexible restraint 120 against the clamping surface 126 when the user has finished adjusting a location of the adjuster 122 relative to the flexible restraint 120. A restraint guide 132 guides the flexible restraint 120 during adjustment.
The frame 124 comprises a bottom wall 134 and a pair of side walls 136, 138 extending perpendicularly from the bottom wall 134 to form a U-shape. The frame 124 may comprise a single piece of material formed into a desired shape, may comprise two or more pieces connected together, or the like. The frame 124 may be formed of metal, composite materials, and/or plastic, combinations thereof, and/or any other suitable materials.
The frame 124 comprises an embossment 140 that extends between the side walls 136, 138. The embossment 140 rises above the bottom wall 134 and provides a flat surface that acts as the clamping surface 126. Owing to its flat configuration, the clamping surface 126 allows for tolerances in the adjuster 122, such as manufacturing variations in the geometry of the cam 130.
The embossment 140 also adds strength to the frame 124. The fabric forming the flexible restraint 120 may be subjected to increased tension loads during a crash event. As the tension loads increase (see arrows in FIG. 4), additional pull on the flexible restraint 120 causes the cam 130 to rotate further (e.g., clockwise in FIG. 4), which further compresses the flexible restraint 120 against the clamping surface 126. The added strength of the embossment 140 reduces deformation of the clamping surface 126 otherwise caused by such clamping forces, thereby helping to avoid uneven loads across the flexible restraint 120, which could result in side tears in the flexible restraint 120.
The restraint guide 132 is provided to guide the flexible restraint 120 relative to the adjuster 122 when adjusting a position of the adjuster 122 relative to the flexible restraint 120. The restraint guide 132 is coupled to the frame 124 and positioned relative to the restraint opening 128 so that the flexible restraint 120 is capable of being routed over the clamping surface 126, wrapped about the restraint guide 132, and passed through the restraint opening 128 (see FIG. 4).
In the version shown, the restraint guide 132 comprises a roller 142 rotatably coupled to the frame 124. The flexible restraint 120 wraps partially around the roller 142 during use, as shown in FIG. 4. Owing to this arrangement, the flexible restraint 120 is capable of transitioning (in direction) at least 180 degrees via the roller 142. The roller 142 rotates about a rotational axis R1 when the user releases the cam 130 from clamping the flexible restraint 120 (see, e.g., FIG. 15B) and moves the adjuster 122/flexible restraint 120 relative to each other during adjustment. In the version shown, the roller 142 is positioned so that a bottom of the roller 142 is at a slightly higher elevation than a bottom surface of the bottom wall 134 such that, under suitable tension, the flexible restraint 120 contacts the bottom surface of the bottom wall 134. Other configurations are also possible.
A pin 144 rotatably couples the roller 142 to the frame 124. The pin 144 comprises a head 146 (see FIG. 3). A shaft 148 extends from the head 146 to support the roller 142. The shaft 148 passes through openings in the side walls 136, 138 (see FIG. 7) and is secured to the frame 124 via a rivet, nut, welding, and/or any other suitable fastener. The pin 144 may be fixed to the frame 124 or may be rotatable relative to the frame 124. In the version shown, the pin 144 acts as an axle about which the roller 142 rotates relative to the frame 124.
The roller 142 may comprise one or more rolling segments 142a, 142b (see FIG. 3). In some cases, the rolling segments 142a, 142b may be capable of rotating relative to each other. The roller 142 and the pin 144 may be formed of metal, composite materials, and/or plastic, combinations thereof, and/or any other suitable materials. In some embodiments, the restraint guide 132 may additionally, or alternatively, comprise a fixed surface, fixed bar, knurled bar, and/or any other suitable guide for guiding the flexible restraint 120 during adjustment.
Referring to FIG. 4A, in addition to the cam 130, a brake 150 may be employed to help arrest movement of the flexible restraint 120 relative to the adjuster 122 during high tension loads (see arrows), such as during a crash event. The brake 150 acts against the roller 142 during such events to prevent rotation of the roller 142 relative to the frame 124, and thus to provide additional friction via sliding of the flexible restraint 120 on the roller 142. In the version shown, the brake 150 forms part of the frame 124, and is defined by a flanged portion 151 of the bottom wall 134. In the version shown, the flanged portion 151 forms an obtuse angle with a main portion of the bottom wall 134. The obtuse angle may be greater than 90 degrees and less than 180 degrees, from 135 degrees to 175 degrees, from 150 degrees to 170 degrees, or any suitable angle.
The brake 150 is spaced from the roller 142 in normal operation, and contacts the roller 142 upon bending of the restraint guide 132 (e.g., bending of the pin 144 and/or rolling segments 142a, 142b) during high tension loads, to brake rotation of the roller 142 (see hidden lines illustrating such bending and showing contact with the roller 142). Thus, the cam 130 of the adjuster 122 acts as a primary locking mechanism that restricts motion of the flexible restraint 120 and absorbs energy and the brake 150 acts as a secondary locking mechanism. The brake 150 further provides additional structure to prevent the pin 144 and/or roller 142 from bending beyond failure in certain situations. For instance, the pin 144 and/or roller 142 are only able to bend slightly before engaging the flanged portion 151 owing to a small gap between an outer surface of the roller 142 and the flanged portion 151. The gap may have a distance (shortest distance from roller 142 to flanged portion 151) of from 0.01 to 0.2 inches, from 0.05 to 0.2 inches, from 0.05 to 0.1 inches, or the like. The flanged portion 151 may have a flat end surface 153 arranged to engage the roller 142 normal to the roller 142. In some cases, a midline axis ML of the flanged portion 151 (see FIG. 4A) passes through the rotational axis R1.
Referring specifically to FIGS. 4 and 11-16B, the cam 130 is rotatably coupled to the frame 124 about a rotational axis R2, which is parallel to rotational axis R1 in some versions. The cam 130 comprises a lever portion 152 arranged to be actuated by the user and a clamping portion 154 opposite the lever portion 152. The lever portion 152 comprises a textured surface for being engaged by a finger of the user to rotate the cam 130 to a releasing position thereby releasing the cam 130 from the flexible restraint 120 for purposes of adjustment (see, e.g., FIG. 15B). The clamping portion 154 is arranged to clamp the flexible restraint 120 against the clamping surface 126 during normal operation (see FIG. 15A). The cam 130 is rotatable from the releasing position to a plurality of clamping positions (see, e.g., FIGS. 4 and 15A). There are various clamping positions owing to the variation in thickness of the flexible restraints 120 that may be used with the adjuster 122 and owing to the amount of tension placed on the harness assembly 102-114, which can increase the clamping force of the cam 130, and thus its rotational position relative to the frame 124.
A pin 155 rotatably couples the cam 130 to the frame 124. The pin 155 comprises a head 157 (see FIG. 3). A shaft 159 extends from the head 157 to support the cam 130 via a through hole 161 in the cam 130. The shaft 159 passes through openings in the side walls 136, 138 (see FIG. 7) and is secured to the frame 124 via a rivet, nut, welding, and/or any other suitable fastener. The pin 155 may be fixed to the frame 124 or may be rotatable relative to the frame 124. In the version shown, the pin 155 acts as an axle about which the cam 130 rotates relative to the frame 124. The cam 130 and the pin 155 may be formed of metal, composite materials, and/or plastic, combinations thereof, and/or any other suitable materials. In some versions, the cam 130 is formed of plastic, such as nylon (e.g., nylon 6, nylon 66), acrylonitrile butadiene styrene (ABS), polycarbonate, polyphenylsulfone (PPSU), ultra high molecular weight (UHMW) polyethylene, or the like.
The clamping portion 154 of the cam 130 comprises teeth 156 shaped to engage and grip the flexible restraint 120 during use to limit slipping of the flexible restraint 120 relative to the adjuster 122. The teeth 156 extend from a body 158 of the cam 130 to tips 160 (see FIG. 14). As will described in greater detail below, the tips 160 of the teeth 156, when viewed in cross-section perpendicular to the rotational axis R2, define a cam profile 162 having a spiral shape (see, e.g., FIG. 14). More specifically, the tips 160 lie along a spiral defined about the rotational axis R2, as shown in FIG. 14. In the version shown, the spiral is an Archimedean spiral or arithmetic spiral defined by the equation (r=a+b*θ), where (r) and (θ) are the polar coordinates of the spiral and parameters (a), (b) define an initial radius of the spiral and the distance between successive turns (if they were present), respectively. In the version shown in FIG. 14, the initial radius (a), which is defined from the rotational axis R2 to the tip 160 of the closest tooth, is about 0.24 inches, and the parameter (b) is about 0.0015. In this version, a final radius (rfinal) from the rotational axis R2 to the tip 160 of the farthest tooth is about 0.37 inches and the angle (θ) between the radiuses (a), (rfinal) is about 84 degrees. So, for example, the equation is satisfied as follows: rfinal=0.37=0.24+(0.0015)*(84). Other versions with different parameters defining the spiral are also contemplated. Each of the teeth 156 has a generally triangular shape in the cross-section and is symmetrical about a midline 164 disposed normal to the cam profile 162.
In the version shown, referring to FIG. 13, chamfers 166 are formed in the clamping portion 154 so that the teeth 156 terminate short of the sides of the cam 130. The chamfers 166 help to prevent the clamping portion 154 of the cam 130 from catching the flexible restraint 120 at radii 168 between the clamping surface 126 of the embossment 140 and inner surfaces of the side walls 136, 138, which could otherwise reduce the clamping force on the flexible restraint 120 allowing the flexible restraint 120 to slip relative to the adjuster 122. In other words, if the cam 130 was otherwise constrained from reaching the clamping surface 126 by virtue of engaging a point along the radii instead, then the cam 130 may not effectively clamp the flexible restraint 120 against the clamping surface 126. The chamfers 166 may be formed at any suitable angle α to provide clearance with the radii 168, such as less than 45 degrees relative to a longitudinal axis LA of the cam 130. The radii 168 may be minimized or reduced to increase contact area with the flexible restraint 120 and mitigate or eliminate edge contact between the teeth 156 of the cam 130 and radii 168. More specifically, by minimizing or reducing the radii 168, the flat area of the clamping surface 126 is increased, thereby providing increased area for clamping.
Referring to FIGS. 8-10, 15A, and 15B, a biasing device 170 acts between the frame 124 and the cam 130 to bias the cam 130 toward the plurality of clamping positions. Thus, the cam 130 is normally biased into a clamping position, as shown in FIG. 15A. The spring-biased nature of the cam 130 allows the flexible restraint 120 to move freely in one direction (e.g., to the right in FIG. 15A when shortening the effective length of the flexible restraint 120), while locking in the other direction (e.g., to the left in FIG. 15A), unless manually released by the user, as shown in FIG. 15B.
The biasing device 170 may comprise a spring 172, such as a torsion spring disposed about the shaft 159 of the pin 155 (see, e.g., FIGS. 8-10). The cam 130 may define a spring pocket 174 on one side to receive the spring 172 (see, e.g., FIGS. 8-10) so that the spring 172 is at least partially hidden from view of the user and inaccessible by the user, without disassembling the adjuster 122. In some versions, the spring 172 may be fully hidden and completely inaccessible by the user. The spring 172 may be present on only one side of the cam 130 in the spring pocket 174, yet a pocket 175 of the same depth may be formed in an opposing side of the cam 130. By employing pockets of the same depth on both sides of the cam 130, loading on the flexible restraint 120 is better balanced. In addition, the spring 172 may be a double offset spring to minimize the likelihood of bending and undesirable jamming of the spring 172. The spring 172 may have opposing tangs 176, 182. The tang 176 is inserted into a tang pocket 180 defined in the cam 130 through the spring pocket 174 (see FIG. 9). The other tang 182 is inserted into an aperture 184 defined through the side wall 138. An end 186 of a fastener (e.g., rivet, nut, etc.) used to secure the shaft 159 to the frame 124 may cover the tang 182 of the spring 172 (see hidden lines in FIG. 9).
Referring to FIGS. 7, 10, 16A and 16B, a stop 190 is coupled to the frame 124 and is arranged to engage the cam 130 upon rotation of the cam 130 by the user from one of the clamping positions to the releasing position. The pocket 175 in the cam 130 is shaped and sized to receive the stop 190. Further, the cam 130 defines an abutment 192 (also referred to as a shoulder) at one end of the pocket 175 arranged to engage the stop 190 upon rotation of the cam 130 by the user to the releasing position. The stop 190 comprises a collar 194 disposed about the pin 155 and a protrusion 196 extending from the collar 194. The protrusion 196 extends through an opening 197 in the side wall 136 (see FIG. 10) and into the pocket 175. The opening in the side wall 136 for the protrusion 196 is sized so that the protrusion 196 is able to fit therethrough, but the protrusion 196 is substantially unable to move in the opening. In other words, the protrusion 196 is effectively fixed to the frame 124.
The collar 194 defines an opening 198 sized to receive the head 157 of the pin 155 and shaped to prevent relative rotation between the pin 155 and the collar 194. In one version, the head 157 and opening 198 having mating double-D shapes to prevent relative rotation between the pin 155 and the collar 194. Other anti-rotation features are also contemplated to prevent relative rotation between the pin 155 and the collar 194.
Operation of the stop 190 is best shown in FIGS. 16A and 16B. In particular, FIG. 16A illustrates the stop 190 being located in the pocket 175 spaced from the abutment 192 when the cam 130 is in one of the clamping positions. The pocket 175 is sized to allow the stop 190 to travel in the pocket 175 as the cam 130 moves to and between the plurality of clamping positions. FIG. 16B illustrates the user releasing the cam 130 by pressing the lever portion 152 and rotating the cam 130 (e.g., counterclockwise in FIG. 16B) until the protrusion 196 of the stop 190 engages and abuts the abutment 192. At this point, the user is unable to further rotate the cam 130 by pressing the lever portion 152. Upon releasing the lever portion 152, the spring-bias applied to the cam 130 returns the cam 130 to the position shown in FIG. 16A. In some cases, the stop 190 is provided to prevent over rotation of the cam 130, which could cause plastic deformation of the spring 172.
FIG. 17 further illustrates the cam profile 162 (in cross-section) at three different clamping positions P1, P2, P3 (e.g., at three different rotational positions of the cam 130). The cam profile 162 comprises a different clamping point 200a, 200b, 200c at each of the different clamping positions P1, P2, P3. Each of the clamping points 200a, 200b, 200c is defined as a nearest point on the cam profile 162 to the clamping surface 126. In the version shown, the clamping points 200a, 200b, 200c are defined as the lowermost points on the cam profile 162, closest to the clamping surface 126. Thus, as the cam 130 rotates to further compress the flexible restraint 120, or to press against a thinner flexible restraint 120, the clamping points 200a, 200b, 200c change by moving closer to the clamping surface 126. At the same time, the clamping points 200a, 200b, 200c change by moving along the cam profile 162 further from a starting point 202 of the cam profile 162 (compare the distance of the clamping points 200a, 200b, 200c from the starting point 202 at each of the clamping positions P1, P2, P3). In the version shown, even though the clamping points 200a, 200b, 200c move further from the starting point 202, all of the clamping points 200a, 200b, 200c substantially lie on a common clamping axis CA normal to the clamping surface 126. It should be appreciated that substantially lying on the clamping axis CA includes clamping points that are slightly off the clamping axis CA, such as clamping points that are within 0.005 inches or less of the clamping axis CA, within 0.002 inches or less of the clamping axis CA, or within 0.001 inches or less of the clamping axis CA. Other configurations of the cam 130 are also contemplated, including, for example, versions in which the clamping points move to the right of the clamping axis CA as the cam 130 rotates.
Referring to FIGS. 18A and 18B, the clamping positions P2 and P3 of the cam 130 are shown along with variables that affect performance of the cam 130 in certain embodiments. Two of these variables include a first distance (x) and a second distance (y). As shown, the cam 130 defines a fixed plane FP passing through the rotational axis R2 and normal to the clamping surface 126. The cam 130 also defines a clamping plane CP parallel to the clamping surface 126 and passing through each of the clamping points 200b, 200c, which may be a tangent plane, defined tangent to the cam profile 162 at the particular clamping point. Each of the clamping points 200b, 200c (and the associated clamping axis CA) are offset from the fixed plane FP by the first distance (x) and the clamping plane CP is offset from the rotational axis R2 by the second distance (y). A ratio of the second distance (y) to the first distance (x) falls within a range of from 2.5 to 5.5, from 2.7 to 4.3, or from 3.0 to 4.0. In some versions, the first distance (x) is from 0.05 inches to 0.1 inches and the second distance (y) is from 0.15 inches to 0.4 inches. In some versions, the first distance (x) at the clamping positions P1, P2, P3 is relatively constant, such as being within a deviation of +/−0.005 inches, +/−0.002 inches, or +/−0.001 inches.
The table shown in FIG. 19 illustrates sample values for the first distance (x) and the second distance (y) at four clamping positions, including the clamping positions P1, P2, P3 (e.g., 15 degrees, 30 degrees, and 45 degrees of rotation). As shown, the first distance (x) is substantially constant between the different clamping positions, the second distance (y) increases with rotation owing to the nature of the cam profile 162 of the cam 130, and the ratio of the second distance to the first distance (y/x) falls within a range of 3.0 to 4.0. Another variable shown in the table is the change in nearest distance (Delta y) from the cam profile 162 to the clamping surface 126 starting from an initial clamping position (0 degrees). Owing to the shape of the cam profile 162, at each increment of rotation (e.g., 15 degrees), the change in distance (Delta y) increases by 0.022 inches. Accordingly, the change in nearest distance (Delta y) from the initial clamping position to: the first clamping position P1 is 0.022 inches; to the second clamping position P2 is 0.022*2 or 0.044 inches; and to the third clamping position P3 is 0.022*3 or 0.066 inches.
As shown in FIG. 20, a chart of the ratio (y/x) relative to the change in nearest distance (Delta y) is substantially linear and nearly constant. It has been found that the clamping force provided by the cam 130 is related to the ratio (y/x). The spiral geometry of the cam profile 162 helps to keep the ratio (y/x) consistent throughout the rotation of the cam 130 and prevent large variations in the clamping force, even with variations in manufacturing tolerance. In some versions, the first distance (x) and the second distance (y) can be measured relative to the tip 160 of the active tooth 156 (e.g., the lowermost tooth that engages the flexible restraint 120) at each of the plurality of clamping positions P1, P2, P3.
FIGS. 21-23 illustrate another example of the biasing device 170 that could be employed to bias the cam 130 toward the plurality of clamping positions. In this example, the biasing device 170 comprises a dual torsion spring 204 having coils 206 disposed about a spring-supporting pin 205. The spring-supporting pin 205 is coupled to the frame 124. The spring-supporting pin 205 may be fixed to the frame 124, such as by rivets, nuts, welding, or the like. When rivets are employed on the spring-supporting pin 205, or any of the other pins described herein, the shaft of the pin may comprise blind holes in both ends that are pop-riveted into place. The rivets thereby provide a cover to both ends of the shaft and provide adequate strength, even with a relatively small diameter. An example of such blind holes are shown in FIGS. 9 and 10 in which the shafts 148, 159 are shown without their associated rivets that would attach to the shafts 148, 159 and secure them to the frame 124.
The dual torsion spring 204 comprises a U-shaped spring end 208 extending from the coils 206. The U-shaped spring end 208 is located beneath the lever portion 152 of the cam 130 to bias upwardly against the lever portion 152 of the cam 130. Sides 210 of the U-shaped spring end 208 run along an inside surface of the side walls 136, 138 of the frame 124, making it less likely for external interference with operation of the dual torsion spring 204. Bent tangs 212 of the dual torsion spring 204 fit into holes 213 formed in the side walls 136, 138 of the frame 124.
FIG. 24 illustrates another example of the biasing device 170 that could be employed to bias the cam 130 toward the plurality of clamping positions. In this example, the biasing device 170 comprises a spring 214 having an arc shape and opposing spring ends 216, 218. In this example, the cam 130 defines a spring through hole 220 to receive the spring 214 such that the ends 216, 218 of the spring 214 extend from the cam 130 on opposing sides of the cam 130 to engage the frame 124. In particular, slots 222 (only one shown) are incorporated into the side walls 136, 138 of the frame 124 to receive the spring ends 216, 218. Thus, the cam 130 substantially encloses the spring 214 to limit the potential for external interference with its function. During normal operation, prior to the lever portion 152 being actuated by the user, a top of the arc of the spring 214 presses against the cam 130 at a top of the spring through hole 220. At the same time, the spring ends 216, 218 press against a bottom surface of the slots 222 to urge the lever portion 152 of the cam 130 upwardly. Thus, the lever portion 152 is biased upwardly and the cam 130 is biased toward the plurality of clamping positions. When the lever portion 152 is actuated by the user, the spring 214 is compressed by virtue of the arc of the spring 214 being pressed downwardly, while the spring ends 216, 218 remain pressed against the bottom surface of the slots 222. When the harness assembly 102-114 is under high tension loads, the lever portion 152 of the cam 130 and the spring 214 rotate upwardly. The slots 222 allow the spring ends 216, 218 to move freely upward if necessary (depending on how far the cam 130 rotates under the high tension loads). Moreover, the angular geometry of the spring through hole 220 (e.g., spaced apart, diverging, flat side surfaces) are such that the spring 214 is able to deform freely in the spring through hole 220 and still allow the cam 130 to rotate. The spring 214 is symmetrical between the spring ends 216, 218 and the spring through hole 220 is uniformly formed through the cam 130 so that the biasing force provided by the spring 214 is applied symmetrically to the cam 130. Furthermore, since the spring through hole 220 is separate from the through hole 161 in the cam 130 that receives the pin 155, the spring through hole 220 does not compromise the balance of loads on the flexible restraint 120. It should be appreciated that the through hole 161 and/or the spring through hole 220 could be formed via injection molding, by machining, or the like.
Referring to FIG. 25, a retainer plate 230 may be used to secure the pins 144, 155 to the frame 124 (see hidden lines showing retainer plate 230 in final position). In this example, each of the pins 144, 155 define keyways 232, 234. The retainer plate 230 is shaped to engage the pins 144, 155 via the keyways 232, 234. In particular, the retainer plate 230 has first keys 236 defining a first slot 238 that extends into a first opening 240 and second keys 242 defining a second slot 244 that extends into a second opening 246. The keys 236, 242 are shaped to fit in the keyways 232, 234 of the pins 144, 155. The retainer plate 230 also has a locking detent 250 to engage the frame 124 via a detent pocket 252 and hold the retainer plate 230 in position relative to the pins 144, 155. During assembly, the pins 144, 155 are placed into their corresponding openings in the side walls 136, 138 such that the distal ends of the pins 144, 155 protrude through one of the side walls 136, 138 exposing the keyways 232, 234 externally. The openings 240, 246 of the retainer plate 230 are then aligned with the pins 144, 155 and fitted over the pins 144, 155 until the keys 236, 242 align with the keyways 232, 234. Once the keys/keyways are aligned, then the retainer plate 230 is moved to place the keys 236, 242 in the keyways 232, 234. Once the keys 236, 242 move far enough into the keyways 232, 234 to suitably secure the pins 144, 155 to the frame 124, the locking detent 250 springs into the detent pocket 252 to hold the retainer plate 230 is position relative to the frame 124. Other locking features may be employed to hold the retainer plate 230 in position relative to the frame 124. In the version shown, the keys 236, 242 and keyways 232, 234 have a mating, double D cross-sectional shape to limit/prevent rotation of the pins 144, 155. Thus, the retainer plate 230 is able to hold multiple pins 144, 155, while also preventing rotation of the pins 144, 155. Other mating configurations (e.g., geometries) to secure the retainer plate 230 onto the pins 144, 155 are also contemplated.
Referring to FIGS. 26-28, another adjuster 300 is shown. In this version of the adjuster, a knurled bar 302 slides relative to a frame 304 during operation. The coating on the coated fabric of the flexible restraint 120 may become tacky when cleaned with certain chemicals. Accordingly, in this version, a roller 306, much like the roller 142, is provided near an edge of an opening 308 in the frame 304. The roller 306 is positioned to reduce or eliminate contact of the flexible restraint 120 with the frame 304, and provide rolling friction, to ease adjustment. The roller 306 can also be positioned to allow contact between the flexible restraint 120 and the frame 304 during adjustment, but while minimizing or reducing the angle of contact between the flexible restraint 120 and the frame 304 to reduce friction.
Several embodiments have been discussed in the foregoing description. However, the embodiments discussed herein are not intended to be exhaustive or limit the invention to any particular form. The terminology which has been used is intended to be in the nature of words of description rather than of limitation. Many modifications and variations are possible in light of the above teachings and the invention may be practiced otherwise than as specifically described.
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17125073
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stryker corporation
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USA
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B2
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Utility Patent Grant (with pre-grant publication) issued on or after January 2, 2001.
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Open
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Apr 27th, 2022 09:01AM
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Apr 27th, 2022 09:01AM
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Stryker
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Health Care
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Health Care Equipment & Services
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nyse:syk
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Stryker
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Apr 26th, 2022 12:00AM
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Jul 9th, 2020 12:00AM
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https://www.uspto.gov?id=US11311385-20220426
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Systems and methods for converting a joint prosthesis from a first type to a second type in-situ
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A joint prosthesis system includes a femoral component that has an articular side, a bone facing side, and medial and lateral condylar portions. The medial and lateral condylar portions at least partially define an intercondylar recess located therebetween and have a first concave surface extending in a mediolateral direction across the medial and lateral condylar portions. A first modular component has a second concave surface and is connectable to the femoral component such that, when the first modular component is connected to the femoral component, the first and second concave surfaces come together to form a transverse opening extending in the mediolateral direction. A first tibial assembly has a baseplate component and a head extending therefrom. The head defines an axle opening that extends therethrough. An axle is configured to be received within the transverse opening and axle opening so as to connect the tibial assembly to the femoral component.
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11311385
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1. A joint prosthesis system for converting a joint prosthesis from a first type to a more constrained second type in situ, comprising:
a femoral component having an articular side, a bone facing side, and medial and lateral condylar portions, the medial and lateral condylar portions at least partially defining an intercondylar recess located therebetween and a transverse opening extending transverse to the articular side and bone facing side, the intercondylar recess intersecting the transverse opening;
a first tibial assembly having a tibial baseplate component and a post extending therefrom;
a first modular component separately formed from the femoral component and being configured to connect thereto, the first modular component having a camming surface configured to articulate with the post of the first tibial assembly;
a second tibial assembly having a tibial baseplate component and a head extending therefrom, the head defining an axle opening extending therethrough; and
an axle configured to be received within the axle opening and transverse opening so as to connect the second tibial assembly to the femoral component.
2. The system of claim 1, further comprising a second modular component having a first member and a second member, the first member having a convex surface corresponding to a concave surface of the transverse opening, and the second member extending from the first member and being configured to engage the first modular component so as to secure the first modular component to the femoral component.
3. The system of claim 2, further comprising a third modular component removably connected to the femoral component and having a concave surface at least partially defining the transverse opening.
4. The system of claim 3, further comprising a fourth modular component having a locking body and a threaded fastener connected to the locking body, the locking body being configured to engage the third modular component when the threaded fastener engages the femoral component.
5. The system of claim 1, further comprising a second modular component removably connected to the femoral component and having a concave surface at least partially defining the transverse opening.
6. The system of claim 1, wherein the femoral component includes a strut extending across the intercondylar recess from the lateral condylar portion to the medial condylar portion, and the first modular component includes a plurality of intersecting walls, wherein a first wall of the plurality of walls includes a mating slot configured to receive the strut of the femoral component when the first modular component is connected thereto.
7. The system of claim 1, wherein the femoral component includes a monolithic body, the transverse opening being a cylindrical opening formed within the monolithic body.
8. The system of claim 7, wherein first modular component defines a groove in communication with the opening thereof.
9. The system of claim 7, further comprising a second modular component having a first member configured to be received within the transverse opening and a second member configured to be received within the opening of the first modular component.
10. The system of claim 1, wherein the first modular component includes a pair of opposing walls and an opening extending through at least one of the walls.
11. The system of claim 1, wherein the tibial baseplate of the first tibial assembly is the same as the tibial baseplate of the second tibial assembly.
12. A joint prosthesis system, comprising:
a femoral component having an articular side, a bone facing side, and medial and lateral condylar portions, the medial and lateral condylar portions at least partially defining an intercondylar recess located therebetween and having a concave surface extending in a mediolateral direction across the medial and lateral condylar portions;
a first tibial assembly having a tibial baseplate component and a post extending therefrom;
a first modular component having a camming surface configured to extend at least partially across the intercondylar recess when the first modular component is connected to the femoral component and to articulate with the post of the first tibial assembly; and
a second modular component having a first member and a second member, the first member having a convex surface corresponding to the concave surface of the femoral component, and the second member extending from the first member and being configured to engage the first modular component so as to secure the first modular component to the femoral component.
13. The system of claim 12, further comprising:
an axle;
a second tibial assembly having a tibial baseplate component and a head extending from the tibial baseplate, the head defining an axle opening extending therethrough; and
a third modular component having a concave surface and being connectable to the femoral component such that, when the third modular component is connected to the femoral component, the concave surfaces of the femoral component and third modular component come together to form a transverse opening extending in the mediolateral direction, the transverse opening being configured to receive the axle therein.
14. The system of claim 12, wherein the second member of the second modular component is a threaded fastener.
15. The system of claim 12, wherein the second member of the second modular component is integral with the first member such that the first and second members form a monolithic body.
16. The system of claim 12, wherein the femoral component includes a monolithic body and the concave surface is a cylindrical surface completely formed by the monolithic body such that the cylindrical surface forms a transverse opening extending through the femoral component.
17. A joint prosthesis system, comprising:
a femoral component having an articular side, a bone facing side, and medial and lateral condylar portions, the medial and lateral condylar portions at least partially defining an intercondylar recess located therebetween and having a first concave surface extending in a mediolateral direction across the medial and lateral condylar portions;
a first modular component having a second concave surface and being connectable to the femoral component such that, when the first modular component is connected to the femoral component, the first and second concave surfaces come together to form a transverse opening extending in the mediolateral direction;
a first tibial assembly having a tibial baseplate component and a head extending therefrom, the head defining an axle opening extending therethrough; and
an axle configured to be received within the transverse opening and axle opening so as to connect the tibial assembly to the femoral component.
18. The system of claim 17, further comprising a second modular component having a locking body and a threaded fastener connected to the locking body, the locking body being configured to engage the first modular component when the threaded fastener engages the femoral component.
19. The system of claim 17, further comprising:
a second tibial assembly having a tibial baseplate component and a post extending therefrom; and
a second modular component having a camming surface configured to extend at least partially across the intercondylar recess when the second modular component is connected to the femoral component and to articulate with the post of the second tibial assembly.
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19
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CROSS-REFERENCE TO RELATED APPLICATIONS
This application claims the benefit of the filing date of U.S. Provisional Patent Application No. 62/873,514, filed Jul. 12, 2019, the disclosure of which is hereby incorporated by reference.
BACKGROUND OF THE INVENTION
The current state of the art in knee replacement surgery offers orthopedic surgeons with a myriad of options to treat their patients, depending on the specific condition to be treated. The vast majority of knee replacement surgery is to treat arthritis of the knee, with trauma and bone cancer being exceptions. Knee replacement surgery to treat arthritis of the knee varies significantly depending on the state of disease progression.
The knee joint consists generally of three distinct regions, the medial tibiofemoral compartment, the lateral tibiofemoral compartment and the patellofemoral compartment. Arthritis of the knee can be limited to one compartment, for example the patellofemoral compartment or the medial tibiofemoral compartment. Conversely, arthritis can be found in two compartments simultaneously, for example the patellofemoral and medial tibiofemoral compartments. Finally arthritis can be found in all three aforementioned compartments.
Knee replacement surgery can be tailored to treat the specific condition diagnosed. For example, for patients with isolated compartmental disease, a partial knee replacement or partial knee arthroplasty (“PKA”) procedure may be performed, such as unicompartmental knee replacement or patellofemoral joint replacement, which are well known and understood in the current state of the art. In patients with arthritis in all three compartments, a total joint knee replacement or total knee arthroplasty (“TKA”) is performed, also well-known and understood in the current state of the art.
Patients who undergo primary knee replacement surgery, whether for a PKA or a TKA, can expect to undergo one or more revision procedures. The causes for revision surgery can vary from mechanical failure of the implant, infection of the joint, aseptic loosening of the implant, or joint instability due to the progression of disease. Continued arthritic changes of the joint over time often results in changes to the quality of the bone as well as deterioration of the strength and efficacy of the ligamentous structures. Deterioration of the ligaments of the knee can be a source of joint instability.
Ligamentous instability often requires implants with increased constraints to be implanted to compensate for the increased deficiency of the ligaments. As an example, a patient who undergoes a primary total knee replacement surgery may receive a cruciate retaining (“CR”) implant, which is indicated when both collateral ligaments as well as the posterior cruciate ligament (“PCL”) are intact and functional. The patient over time may develop mid-flexion instability and may be revised to a posterior stabilized (“PS”) component whereby the function of the deteriorating PCL is substituted by an implant employing a cam and post design, well known and understood in the art. Said patient may also develop varus/valgus instability as a result of weakened or attenuated collateral ligaments and may alternatively be revised with a total stabilized (“TS”) implant whereby a cam and post with increased constraint is used to augment the compromised collateral ligaments. Finally, in severe cases a TS implant may be insufficient to compensate for the total loss of function of the collateral ligaments. In such severe cases, a hinge implant may be indicated. Hinge implants are the most constrained of all knee systems and typically comprise femoral and tibial prostheses that are connected together via an axle which forms a hinge about which the artificial joint flexes and extends.
Amongst the many drawbacks associated with revision knee surgery are the loss of bone associated with the explantation of the prior components as well as the potential risks associated with increased surgical time due to the long and tedious process of implant removal. These drawbacks are most apparent in cases requiring a TS implant to be revised to a hinge implant due to joint instability. In many cases, TS femoral and tibial implants may exhibit solid cement fixation and may also be deemed to be in good anatomic alignment. However, due to collateral ligament instability, all of the TS implant's components may have to be explanted in favor of a hinge implant because none of the design characteristics of such TS components are compatible with the hinge implant. Further complicating the removal of a well fixed (cemented) TS implant is the fact that they are often used with intramedullary stems, both in the tibia and the femur, which are not easy to extract from the bone particularly without compromising the structure of the bone. Thus, further improvements are desirable.
BRIEF SUMMARY OF THE INVENTION
The present disclosure describes implant systems in which a TS implant can be converted to a hinge implant in situ without the TS implant being removed from the bone and at a fraction of the time typically required to revise a TS implant to a hinge implant. Preferably, the modular TS-to-Hinge conversion implant would be factory assembled in a TS configuration in order to make its use in the operating room identical to current TS implants. Meeting this preferred scenario is not without significant challenges. For example, the kinematics, spatial constraints and strength requirements for both TS and hinge applications are sufficiently distinct enough that addressing the design requirements for one often comes at the expense of the other. With respect to the surgeons' expectations and the patients' clinical needs, if a “convertible” TS-to-Hinge implant design were to be available, the performance requirements for each, whether in a TS mode or a Hinge mode should be virtually the same to each respective implant as a stand-alone component. In other words, TS-to-Hinge convertibility should not come at the expense of implant performance and/or durability, regardless of how easy the conversion may be. The devices, systems, and methods described herein address these potential pitfalls.
In one aspect of the present disclosure, a method of converting a joint prosthesis from a first type to a more constrained second type in situ, includes: removing a first modular component from a femoral component that was previously implanted onto a distal femur while the femoral component remains connected to the distal femur, the first modular component having a cam surface configured to articulate with a post of a first tibial assembly; and connecting an axle to the femoral component and to a second tibial assembly while the femoral component remains connected to the distal femur.
In another aspect of the present disclosure, a joint prosthesis system for converting a joint prosthesis from a first type to a more constrained second type in situ, includes a femoral component that has an articular side, a bone facing side, and medial and lateral condylar portions. The medial and lateral condylar portions at least partially define an intercondylar recess located therebetween and a transverse opening extending transverse to the articular side and bone facing side. The intercondylar recess intersects the transverse opening. The system also includes a first tibial assembly that has a tibial baseplate component and a post extending therefrom. Also included in the system is a first modular component separately formed from the femoral component and which is configured to connect thereto. The first modular component has a camming surface configured to articulate with the post of the first tibial assembly. The system further includes a second tibial assembly that has a tibial baseplate component and a head extending therefrom. The head defines an axle opening extending therethrough. An axle is configured to be received within the axle opening and transverse opening so as to connect the second tibial assembly to the femoral component.
In a further aspect of the present disclosure, a joint prosthesis system, includes a femoral component that has an articular side, a bone facing side, and medial and lateral condylar portions. The medial and lateral condylar portions at least partially define an intercondylar recess located therebetween and have a concave surface that extends in a mediolateral direction across the medial and lateral condylar portions. The system also includes a first tibial assembly that has a tibial baseplate component and a post extending therefrom. The system further includes a first modular component that has a camming surface configured to extend at least partially across the intercondylar recess when the first modular component is connected to the femoral component and to articulate with the post of the first tibial assembly. Also included in the system is a second modular component that has a first member and a second member. The first member has a convex surface corresponding to the concave surface of the femoral component. The second member extends from the first member and is configured to engage the first modular component so as to secure the first modular component to the femoral component.
In a yet further aspect of the present disclosure, a joint prosthesis system, includes a femoral component that has an articular side, a bone facing side, and medial and lateral condylar portions. The medial and lateral condylar portions at least partially defining an intercondylar recess located therebetween and having a first concave surface extending in a mediolateral direction across the medial and lateral condylar portions. The system also includes a first modular component that has a second concave surface and is connectable to the femoral component such that, when the first modular component is connected to the femoral component, the first and second concave surfaces come together to form a transverse opening extending in the mediolateral direction. The system further includes a first tibial assembly that has a tibial baseplate component and a head extending therefrom. The head defines an axle opening extending therethrough. An axle is configured to be received within the transverse opening and axle opening so as to connect the tibial assembly to the femoral component.
BRIEF DESCRIPTION OF THE DRAWINGS
The features, aspects, and advantages of the present disclosure will become better understood with regard to the following description, appended claims, and accompanying drawings in which:
FIG. 1A is a side elevational view of a first prior art femoral component.
FIG. 1B is a side elevational view of a second prior art femoral component.
FIG. 2A is a side elevational view of a femoral component according to an embodiment of the present disclosure.
FIG. 2B is a perspective view of the femoral component of FIG. 2A.
FIG. 3A is a perspective view of a box locking housing according to an embodiment of the present disclosure.
FIG. 3B is a perspective view of a modular box member according to an embodiment of the present disclosure.
FIG. 4A is a perspective view of an assembly according to an embodiment of the present disclosure including the femoral component of FIG. 2A, the box locking housing of FIG. 3A, and modular box member of FIG. 3B.
FIG. 4B is a bottom view of the assembly of FIG. 4A.
FIG. 4C is a side cross-sectional view of the assembly if FIG. 4A taken along a midline thereof.
FIG. 4D is a perspective view of a tibial insert according to an embodiment of the present disclosure.
FIG. 4E is a perspective view of a tibial baseplate according to an embodiment of the present disclosure.
FIG. 5A is a perspective view of a hinge housing component according to an embodiment of the present disclosure.
FIG. 5B is a perspective view of a locking wedge according to an embodiment of the present disclosure.
FIG. 6A is a perspective view of an assembly according to another embodiment of the present disclosure including the femoral component of FIG. 2A, the hinge housing component of FIG. 5A, and locking wedge of FIG. 5B.
FIG. 6B is a perspective view of the assembly of FIG. 6A.
FIG. 6C is a side cross-sectional view of the assembly of FIG. 6A taken along a midline thereof.
FIG. 6D is a perspective view of a tibial assembly according to an embodiment of the present disclosure.
FIG. 6E is a perspective view of a partial hinge implant assembly including the femoral component of FIG. 2B and tibial assembly of FIG. 6D.
FIG. 6F is a perspective view of a partial hinge implant assembly including the hinge housing component of FIG. 5A, locking wedge of FIG. 5B, and tibial assembly of FIG. 6D.
FIG. 7A is a perspective view of a cement nozzle according to an embodiment of the present disclosure.
FIG. 7B is perspective cross-sectional view of the cement nozzle of FIG. 7A taken along a midline thereof.
FIG. 7C is a perspective cutaway view of an assembly according to an embodiment of the present disclosure including the assembly of FIG. 6A and cement nozzle of FIG. 7A.
FIGS. 8A-8F depict a method of converting the femoral component of FIG. 2A from a first configuration to a second configuration in situ.
FIG. 9A is a perspective view of a femoral component according to a further embodiment of the present disclosure.
FIG. 9B is an exploded perspective view of an assembly according to a further embodiment of the present disclosure including the femoral component of FIG. 9A.
FIG. 9C is a perspective view of the assembly of FIG. 9B, as assembled.
FIG. 9D is an exploded perspective view an assembly according to a yet further embodiment of the present disclosure including the femoral component of FIG. 9A.
FIG. 9E is a rear perspective view of the assembly of FIG. 9D, as assembled.
FIG. 9F is a front perspective view of the assembly of FIG. 9D, as assembled.
DETAILED DESCRIPTION
When referring to specific directions in the following discussion of certain implantable devices, it should be understood that such directions are described with regard to the implantable device's orientation and position during exemplary application to the human body. Thus, as used herein, the term “proximal” means close to the heart, and the term “distal” means more distant from the heart. The term “inferior” means toward the feet, and the term “superior” means toward the head. The term “anterior means toward the front of the body or the face, and the term “posterior” means toward the back of the body. The term “medial” means toward the midline of the body, and the term “lateral” means away from the midline of the body. Also, as used herein, the terms “about,” “generally” and “substantially” are intended to mean that deviations from absolute are included within the scope of the term so modified.
FIG. 1A depicts a prior art TS femoral component 6 that includes a bone facing side and an articular side. The bone facing side includes a plurality of intersecting bone facing surfaces 1-5. As shown, a typical TS femoral component 6 includes five of such intersecting bone facing surfaces. When femoral component is implanted, these bone facing surfaces 1-5 interface with corresponding resected surfaces of a distal femur. In this regard, distal femurs are commonly resected so as to exhibit five planar intersecting surfaces which are commonly understood as an anterior resection, posterior resection, distal resection, anterior chamfer resection, and posterior chamfer resection.
Since TS femoral component 6 is ordinarily indicated for circumstances where a patient's collateral ligaments exhibit some laxity such that some level of constraint is required to stabilize the artificial joint, TS femoral component 6 includes a cam box 7 and stem boss 8. Cam box 7 extends superiorly from bone contacting surfaces 1-4 and contains a cam surface (not shown) within an interior thereof at the articular side of the femoral component 6. Such cam surface articulates with a post of a tibial insert, such as the tibial insert 200 depicted in FIG. 4D and described further below. This cam-post mechanism provides functionality ordinarily performed by the cruciate ligaments, such as femoral roll-back, which are typically sacrificed in TS procedures, and also helps stabilize the artificial joint in the face of collateral ligament instability. Further support is provided to femoral component by way of stem boss 8 and a stem (not shown) connected to stem boss 8. PS femoral components are similar to TS femoral component 6 except that PS femoral components typically do not include intramedullary stems.
FIG. 1B depicts a prior art hinge femoral component 10 which includes a bone contacting side and an articular side. The bone contacting side includes a plurality of intersecting bone facing surfaces 11-14. However, unlike the TS femoral component 6, hinge femoral component 10 is shown as having four of such surfaces rather than five. This is to help create enough space at a posterior aspect of femoral component 10 to accommodate a transverse opening 16. Transverse opening 16 passes through femoral component 10 in a mediolateral direction between the bone facing and articular sides and is sized to accommodate an axle of a tibial assembly. An exemplary hinge knee assembly and corresponding femoral component, axle, and tibial assembly are disclosed in U.S. Publication No. 2017/0035572 (“the '572 Publication”), the disclosure of which is hereby incorporated by reference herein in its entirety. It is noted that, while hinge femoral component 10 also includes a stem boss 18, femoral component 10 does not include a cam box since the axle that connects to femoral component 10 provides the appropriate constraint, rather than a cam-post mechanism like that of TS femoral component 6.
The prior art femoral components 6 and 10, as described above, include two separate features which are utilized to constrain the artificial joint, the first being cam box 7 for the cam-post mechanism, and the second being the transverse opening 16 and corresponding hinge axle. It is particular noted that a hinge axle undergoes significant stress over the lifetime of use and, therefore, has a large diameter for strength. However, this comes at the cost of space which is not in abundance on a femoral component. Attempts to make the axle smaller in an effort to be more bone preserving have resulted in designs with higher clinical failure rates. Thus, developing a femoral component that can be converted in situ from a TS configuration to a hinge configuration without removal of the same comes with particular challenges. For example, when the axle location (DIM A & B) is superimposed on the TS femoral component 6, a posterior wall 17, such as that shown in FIG. 1B, results but is thinned out relative to that of femoral component 10, thus potentially negatively affecting the strength of the resulting femoral component when loaded posteriorly, such as would occur in deep flexion, for example as in rising from a chair. Moreover, as mentioned above, TS femoral component 6 has more intersecting bone facing surfaces than hinge femoral component and is, therefore, more bone preserving. While such additional bone removal is acceptable in a hinge surgery scenario, such is not typically the case in a TS scenario. Thus, the design challenges involve competing design features. The devices, systems, and methods described below solve these design challenges and more.
FIGS. 2A-7C depict a system for converting a joint prosthesis from a first type to a more constrained second type in situ. The system generally includes a femoral component 20, TS modular components (40, 50), hinge modular components (60, 70), a first tibial assembly (200, 210), and a second tibial assembly 80.
FIGS. 2A-2B depict a base femoral component 20 according to an embodiment of the present disclosure. Femoral component 20 generally includes a bone facing side, an articular side, lateral and medial condylar portions 32a-b, and a strut 36. Lateral and medial condylar portions 32a-b are separated by an intercondylar recess or notch 31. Strut 36 is connected to lateral and medial condylar portions 32a-b and extends across intercondylar recess 31. In the embodiment depicted, strut 36 connects to lateral and medial condylar portions 32a-b at respective ends thereof.
The bone facing side includes a plurality of intersecting inner bone facing surfaces 21-24, a partial hinge housing 37, interlocking features 34a-b, a partial cam box or base 27, and a stem boss 28.
The plurality of intersecting bone facing surfaces 21-24 are generally planar surfaces that correspond to resected surfaces of a distal femur. While such surfaces 21-24 are generally planar, they can include depressions and the like for receipt of bone cement, for example. However, their profiles are each as a planar surface to match a corresponding planar resected surface of a femur. In the embodiment depicted, femoral component 20 includes four bone facing surfaces 21-24 that correspond to four resected surfaces of a femur. Femoral component 20 may, however, have five of such inner surfaces, although femoral component preferably includes four inner bone facing surfaces 21-24 in order to accommodate partial hinge housing 37. In other embodiments, the bone facing side may have only three bone facing surfaces which would also accommodate partial hinge housing 37. However, four inner bone facing surfaces 21-24 is preferred over three because it allows for less bone removal than three inner surfaces while providing for sufficient space for partial hinge housing 37.
While femoral component 20 includes four inner bone facing surfaces 21-24, it should be noted that inner surface 25b (see FIG. 2A), which corresponds to surface 2 of TS femoral component, has been eliminated in order to accommodate partial hinge housing 37 and interlocking features 34a-b. Moreover, inner bone facing surface 25b (see FIG. 2A), which corresponds to first inner surface 1 of femoral component 6, has been replaced by first inner bone facing surface 21. Bone facing surface 21 is shifted parallel and anterior to surface 25a. However, while this results in more bone removed from a distal femur as compared to femoral component 6, such additional bone removed by the substitution of surface 21 for surface 25a is consistent with what would be removed for accommodation of an augment block (not shown) that is commonly used in TS revision procedures to address posterior-condylar bone loss. Thus, the additional bone that would be removed to accommodate femoral component 20 would not go beyond commonly accepted parameters for TS procedures.
Partial hinge housing 37 extends from the bone facing side into femoral component 20 toward the articular side. In particular, hinge housing 37 extends through first inner surface 21, which is a surface that extends in a superior-inferior direction. Hinge housing 37 is defined by a concave surface that 35 extends across lateral and medial condylar portions 32a-b. However, concave surface 35 is interrupted by intercondylar recess 31 such that concave surface 35 forms a lateral concave surface 35a and medial concave surface 35b. Such concave surfaces 35a-b, in the embodiment depicted, are semi-cylindrical, and more particularly hemi-cylindrical. However, in some embodiments concave surfaces 35a-b may form less or more than half of a cylinder.
As shown in FIG. 2A, femoral component 20 maintains the same axle housing size (DIA. C in FIGS. 1B and 2A) and location (DIMs. A and B in FIGS. 1B and 2A) as hinge femoral component 10. However, femoral component 20 does not require as much bone removal as femoral component 10 because the axle housing is composed of two halves, the first half being partial housing 37 which is integral to the femoral component and described above, and the second half, which is not present while in a TS configuration, is comprised of a modular component 60, described below. However, it is noted that a thickness 26 of femoral component between concave surface 35 and the articular side of femoral component is diminished relative to femoral component 10. However, whatever strength is lost due to this reduction in thickness 26 is compensated for by making a modular box component 50 (see FIG. 3B) a stressed member to share the load, as described further below.
Interlocking features 34a-b are located at lateral and medial flanks of partial hinge housing 37 and extend superiorly from femoral component 20. In this regard, interlocking features 34a-b are protrusions that form abutments for modular components disposed within partial hinge housing 37, as described further below.
Partial cam box or base 27 extends superiorly from the bone facing side of femoral component 20. In particular, cam box 27, as shown, interrupts and extends from second and third inner surfaces 22, 23. Partial cam box 27 is located at an anterior extent of intercondylar recess 31 and terminates well before reaching first inner surface 21 such that a rectangular shaped gap extends between first inner surface 21 and partial cam box 27, as best shown in FIG. 2A. Partial cam box 27 includes a plurality of box walls 29 extending posteriorly from a posterior end of partial box 27 (see FIGS. 2A, 2B, 4B, and 4C). In particular, a first, second, and third wall 29a-b intersect each other so as to form a generally rectangular recess therein with third wall 29c forming a ceiling of partial box 27.
Stem boss 28 extends superiorly from partial cam box 27 and includes an opening therein for receipt of a modular stem (not shown). However, in some embodiments, stem boss 28 may instead be an integral full-length stem incorporated into the structure of femoral component 20. The bone facing side may include a porous material, such as titanium foam and the like for promoting bone ingrowth, such as when femoral component 20 is press-fit to a femur. However, the bone facing side may instead include solid surfaces for instances in which femoral component 20 is cemented to a femur.
FIGS. 3A and 3B depict the TS modular components which include a box locking housing 40 and a modular box 50. These modular components are utilized in conjunction with base femoral component 20 to create a TS mode femoral component 20′. Box locking housing 40 has a semi-cylindrical body such that one side thereof has a convex surface 42 and another side thereof has a planar surface 48. Box locking housing 40 is configured to be received by partial hinge housing 37. In this regard, convex surface 40 is curved to correspond with one of concave surfaces 35a-b. In addition, planar surface 48 is configured to be an extension of first inner bone facing surface 21 when box locking housing 40 is engaged to femoral component 20. Thus, planar surface 48 is also a bone facing surface and includes depressions or grooves 47 therein which are configured to receive bone cement.
Box locking housing 40 also has a first end and a second end. The first end includes an interlocking feature 41 which is a section of reduced cross-sectional dimension from the remainder of the box locking housing's body such that this reduced shape/size forms abutment shoulders 49. In this regard, interlocking feature 41 is configured to be received within a space between interlocking feature 34a or 34b and an end of hinge housing 37. The abutment shoulders 49 are configured to abut interlocking feature 34a-b. Thus, it should be noted, that box locking housing 40 is loaded into hinge housing 37 via intercondylar recess 31. As such, box locking housing 40 has a length that is smaller than a mediolateral width of intercondylar recess 31. The second end of box locking housing 40 is generally planar and is configured to abut walls of modular box 50 when assembled with femoral component 20. Box locking housing 40 defines a threaded opening 44 spanning the entire length thereof, and includes a screw 45 with a threaded shaft 43 and a non-threaded post 46 at an end of threaded shaft 43.
Modular box 50 generally includes a plurality of box walls 54 and a cam surface 59. In particular, modular box 50 includes three box walls 54a-c in which first and second box walls 54a-b are opposed to each other, and third box wall 54c extends transverse to first and second walls 54a-b and connects the two to create a rectangular structure with an open inferior end. Cam surface 59, as shown in FIG. 4B, is located within an interior of box 50 and spans between first and second box walls 54a-c. Cam surface 59 is configured to articulate with a post of a tibial assembly. Modular box 50 includes an anterior end and a posterior end. The anterior end includes an abutment face 56 formed by the ends of box walls 54a-c. Abutment face 56 is substantially planar. At the posterior end, first and second box walls 54a-b form convexly curved ends or wings 58 so as to match a curvature of condylar portions 32a-b. First and second box walls 54a-b each include an aperture 52 configured to receive the non-threaded post 46 of screw 45. In addition, first and second box walls 54a-b each include elongate grooves 53 that extend in a superior-inferior direction. Such grooves 53 allow for the interdigitation of bone cement to help secure box 50 to bone. However, the travel of elongate grooves 53 in the superior-inferior direction allows box 50 to be easily removed from femoral component 20, even when cemented, during a transition to a hinge configuration as such grooves 53 extend in the same direction of travel for removal of box component 50. Third wall 54c includes a mating slot 51 that extends in a mediolateral direction and is configured to receive strut 36 of femoral component.
FIGS. 4A-4C depict a TS configured femoral component 20′. TS configured femoral component 20′ includes femoral component 20, modular box 50, and a pair of modular box housings 40. As shown, modular box 50 is positioned within intercondylar recess 31 such that the anterior end of box walls 54a-c abut corresponding partial box walls 29a-c of partial cam box 27. In addition, convexly curved posterior ends 58 of first and second walls 54a-b engage with and curve along with the curvature of lateral and medial condylar portions 32a-b, as best shown in FIG. 4A. Also, strut 36 is positioned within mating slot 51.
First and second modular box housings 40a-b flank partial cam box 50 and are positioned within partial axle housing 37. In this regard, convex surfaces 42 of modular box housings 40a-b correspondingly engage concave surfaces 35a-b of their respective lateral and medial condylar portions 32a-b. Abutment shoulders 49 of box locking housings 40 abut interlocking features 34a-b of femoral component 20 while interlocking features 41 extend between interlocking features 34a-b and concave surfaces 35a-b. Planar surfaces 48 of housings 40a-b also lay flush with first bone facing surface 21 of femoral component so as to extend first bone facing surface 21. A locking screw 45 is positioned within the threaded opening 44 of each box housing 40a-b such that non-threaded post 46 extends from the first end 43 thereof and into an aperture 52 of a respective box wall 54a-b to secure box 50 to femoral component 20.
As mentioned above, thickness 26 of femoral component 20 is lessened compared to that of femoral component 10. To help reduce stress in this region, posterior compressive load experienced in deep flexion is transferred through modular box 50 via strut 36, which is coupled to mating slot 51, and the anterior abutment surface 56 formed by box walls 54a-c being in contact with corresponding walls 29a-c of femoral component 20. In this regard, loads applied to condylar portions 32a-b are at least partially transferred through box locking housing 40, screws 45, apertures 52, and finally through the length of box 50 onto integral base 27. Therefore, modular box 50 contains multiple points of load transfer.
FIGS. 4D and 4E depict a first tibial assembly or TS tibial assembly. TS tibial assembly includes a tibial insert 200 and baseplate component 210. Tibial insert 200 generally includes an articular side that is comprised of lateral and medial condyles 204a-b which are concave surfaces configure to articulate with femoral component 20. In addition, tibial insert 200 includes a post 202 extending therefrom. Post 202 is configured to be received within intercondylar recess 31 of femoral component 20 and to articulate with cam surface 59 in order to help prevent anterior subluxation and to provide functionality lost due to the sacrifice of the cruciate ligaments. Insert 200 is preferably made from a biocompatible polymer material, such as an ultra-high molecular-weight polyethylene (UHMWPE), for example.
Baseplate component 210 includes a baseplate 212, keels 214, and stem portion 216. Keels 214 and stem portion 216 extend inferiorly from baseplate 212. Baseplate 212 includes a superior tray 218 configured to receive tibial insert 200.
FIGS. 5A and 5B depict the hinge modular components which include a hinge housing component 60 and locking wedge or locking block 70. As indicated above, the hinge axle housing comprises two portions, the first portion is the concave surface integral 35 to femoral component 20. The second portion is modular hinge housing component 60. Modular hinge housing component 60 includes an inner concave surface 61 and an outer convex surface 62 concentric to first concave surface 61. Outer convex surface 62 includes a rib 67 extending transverse to a length of component 60. Such rib 67 is configured to be received within a corresponding groove of locking wedge 70, as described in more detail below. Concave surface 61 in the embodiment depicted, is semi-cylindrical, and more particularly hemi-cylindrical. However, in some embodiments concave surface 61 may form less or more than half of a cylinder. Housing component 60 also includes a plurality of apertures 63 and a plurality of grooves 64 each intersecting a corresponding one of such apertures 63. Apertures 63 allow bone cement to be delivered therethrough, as described below, and grooves 64 are interlocking features for the bone cement to secure housing component 60 to bone.
Locking wedge or locking block 70 is used to secure hinge housing component 60 to femoral component 20. Locking wedge 70 includes a body 76 that has a concave surface 71 which matches outer convex surface 62 of housing component 60. In this regard, concave surface 71 has a groove 77 extending along the curvature of surface 71 and is configured to receive rib 67, as best shown in the cross-section of FIG. 6C. Body 76 also includes an abutment surface 74 disposed opposite concave surface 71 for abutting surface of partial box 27. A protrusion 75 extends from abutment surface 74 and has a cross-sectional dimension smaller than that of body 76 such that protrusion 75 can be received within the recess formed by partial box walls 29a-c. In this regard, protrusion 75 centralizes as well as stabilizes locking wedge 70 to allow distal-proximal translation of the locking wedge 70 while preventing medial-lateral shift of said locking wedge 70. Locking wedge 70 further includes a threaded opening 72 extending in a superior-inferior direction entirely through protrusion 75. Threaded hole 72 is configured to receive wedge locking screw 73.
FIGS. 6A-6C depict a hinge configured femoral component 20″. Hinge configured femoral component 20″ includes femoral component 20, modular hinge housing 60, and a locking wedge 70. As shown, hinge housing component 60 is positioned opposite partial hinge housing 37 such that concave surfaces 35 and 61 come together to form a transverse opening 65. Transverse opening 65 is generally cylindrical and is configured to receive an axle and corresponding bushings of a tibial assembly, as described below. In this regard, transverse opening 65 forms a diameter (DIA. C of FIG. 6C) which is identical in size and location to that of FIG. 1B thereby ensuring transverse opening 65 can accommodate a robust axle. Also, as best shown in FIGS. 6A and 6C, locking wedge 70 is positioned within a gap between partial box 27 and hinge housing component 60 such that protrusion 75 is positioned within box walls 29a-c of partial box 27 and concave surface 71 contacts convex surface 62 of housing component 60. In addition, rib 67 of housing 60 is received within groove 77 of wedge 70, as best shown in FIG. 6C, so as to constrain housing 60 from mediolateral movement. Locking screw 73 secures locking wedge to femoral component 20.
FIG. 6D depicts a second tibial assembly or hinge tibial assembly 80. Hinge tibial assembly 80 generally includes a baseplate component 81, tibial insert 86, bearing component 84, axle bushings 102a-b, and a bearing shaft bushing (not shown). Examples of such components can be found in the heretofore referenced '572 Publication. Baseplate component 81 includes a stem portion 88 and baseplate 87. An opening extends through baseplate 87 and into stem portion 88.
Tibial insert 86 includes a concave articular surface 83 and a through-opening. Bearing component 84 includes a bearing plate 89, bearing shaft 88 extending from bearing plate 89, and a head 85 extending superiorly from bearing plate 89. Head 85 includes an axle opening extending therethrough in a mediolateral direction which is configured to receive the axle 100. Bushings 102a-b are made of polymer material and receive the portions of axle 100 not received within head 85, as shown in FIG. 6D. Such bushings 102a-b prevent metal-on-metal rubbing during use. In the embodiment depicted, bearing plate 89 is convexly curved so that it can articulate with concave surface 83 of tibial insert 86. However, in other embodiments, femoral component 20 may directly articulate with tibial insert 86. Thus, in such embodiments bearing component 86 may not include bearing plate 89.
FIGS. 6E and 6F depict hinge tibial assembly 80 assembled with hinge configured femoral component 20″. In this regard, tibial insert 86 is connected to baseplate 81 while bearing shaft 88 extends from bearing plate 89 and through both tibial insert 86 and baseplate 81 and into the opening thereof such that bearing plate 89 rests on tibial insert 86. Head 85 extends through intercondylar recess 31 such that the axle opening aligns with transverse opening 65. Axle 100 is positioned within transverse opening 65 and the axle opening so as to connect femoral component to tibial assembly 80. Moreover, bushings 102a-b are positioned over axle and between femoral component 20 and housing 60 so as to prevent metal-on-metal articulation. Femoral component 20″ and tibial assembly 80 articulate in flexion and extension relative to each other about an axis defined by axle 100.
FIGS. 7A and 7B depict a disposable bone cement nozzle 90 that can be connected to a cement applicator device (not shown), such as a standard bone cement gun. Such nozzle 90 is particularly configured to deliver bone cement around modular axle housing 60 while femoral component 20 remains attached to a femur in order to help secure such element to the bone after conversion from TS configured femoral component 20′ to hinge configured femoral component 20″. In this regard, cement nozzle 90 includes a first member 94 and a second member 92. First member 94 extends along a first longitudinal axis and defines an inlet aperture 98a at a terminal end thereof. As shown, first member 94 has a rectangular profile. However, first member 94 may be cylindrical or the like.
Second member 92 is connected to first member 94 and extends along a second longitudinal axis which is perpendicular to the first longitudinal axis. Second member 92 includes a first cylindrical portion 95a and a second cylindrical portion 95b. First and second cylindrical portions 95a-b have an equal diameter and are concentric with each other. First and second cylindrical portions 95a-b are offset from each other such that they form a circumferential groove 96 therebetween. An outlet aperture 98b intersects groove 96 transverse to the second longitudinal axis. A passageway or channel 97 extends through first member 94 and second member 92 and is in communication with inlet and outlet apertures 98a-b. In this regard, bone cement injected through inlet aperture 98a passes through passageway 97 and out of outlet aperture 98b.
FIG. 7C depicts bone cement applicator 90 coupled to femoral component 20″ as it would be in use. As shown, first member 94 extends through intercondylar recess 31 while second member 92 extends transversely thereto and into transverse opening 65 at one of lateral or medial condylar portions 32a-b. In this regard, outlet aperture 98b is positioned within transverse opening 65 so that circumferential groove 96 is aligned within openings 63 of hinge housing component 60 and first and second cylindrical portions 95a-b are flush against concave surfaces 35 and 61 of femoral component 20 and hinge housing component 60, respectively. This allows bone cement to be directed out of outlet aperture 98b, into groove 96, and then out of apertures 63 under pressure so that cement fills grooves 64 and extends about convex outer surface 62 of modular housing 60.
Another device included in the system is an osteotome or cutting tool 110. Osteotome 110 is used to cut a femur when performing a TS-to-hinge conversion so as to make room for modular hinge housing 60, as described below. Osteotome 110 includes a body 111 with a through-opening 116 extending entirely therethrough. A proximal end of osteotome has an impact surface 112 for being impacted by a mallet or the like. A distal end of osteotome has a cutting member 114 that extends from body 111. Cutting member 114 has a semi-cylindrical shape to match that of modular hinge housing 60.
FIGS. 8A to 8F depict a method of converting a joint prosthesis from a first type to a more constrained second type of prosthesis in situ. In the method, TS configured femoral component 20′ and the first tibial assembly comprising tibial baseplate component 210 and tibial insert 200 had been previously implanted onto a distal femur and proximal tibia, respectively. However, due to collateral ligament laxity and/or some other defect, a revision procedure to a more constrained hinge knee prosthesis is indicated. As such, a subsequent procedure is performed in which the operator gains access to the previously implanted prosthesis and decouples TS configured femoral component 20″ from tibial insert 200. Baseplate component 210 and tibial insert 200 are removed from the proximal tibia. However, femoral component 20 remains connected to the femur so that it can be converted to hinge configured femoral component 20″ without disrupting the underlying bone by removing the entirety of femoral component.
In order to convert TS configured femoral component 20′ to hinge configured femoral component 20″, the TS modular components are disassembled from femoral component 20. This begins by removal of locking screws 45 from the flanking box locking housings 40, as shown in FIG. 8A. As such, non-threaded posts 46 are also backed out of their positions within apertures 52 of modular box member 50 allowing modular box component 50 to be removed from femoral component 20. In this regard, once locking screws 45 are removed, modular box 50 is slid distally out of intercondylar recess 31. Although modular box 50 may have been cemented to the bone, the direction of longitudinal grooves 53 facilitates an easy removal.
Once modular box 50 is removed from femoral component 20, the femur is resected to make space for modular hinge housing component 60. In this regard, a guide rod 115 is threaded to opening 44 of second box housing 40b, as shown in FIG. 8C. Thereafter, osteotome 110 is advanced over guide rod 115 such that guide rod 115 is received within the through-opening 116 of osteotome 110. Impact surface 112 is then impacted to advance cutting member 114 into the bone thereby resecting the bone to form a curved resected surface configured to contact outer convex surface 62 of modular hinge housing 60. This resection procedure is repeated for the opposite side of the bone.
Once the bone is resected to receive modular hinge housing 60, osteotome 110 and guide rod 115 are removed from the locking box housings 40a-b. Locking box housings 40a-b are then removed from femoral component 20 sequentially. In this regard, medial locking box housing 40b is removed by sliding it in a mediolateral direction toward intercondylar recess 31, as shown in FIG. 8E. Once housing 40b is within intercondylar recess 31 it can be removed through recess 31. This is repeated for the lateral housing 40a. It should be understood that lateral housing 40a could be removed first as it does not matter which housing 40a or 40b is removed first.
At this point the TS configured femoral component 20′ has been disassembled down to base femoral component 20. Next, the hinge modular components are assembled to femoral component 20 in order to form hinge configured femoral component 20″. This is achieved by first connecting locking wedge 70 to femoral component 20 by inserting it through intercondylar recess 31, as illustrated by one of the arrows in FIG. 8F, so that protrusion 75 is received within walls 29a-c of partial box 27 thereby constraining wedge 70 from mediolateral movement. Locking screw 73 is engaged to a corresponding aperture within partial cam box 27 of femoral component 20. Thereafter, modular axle housing 60 is slid in a mediolateral direction into the previously prepared opening in the bone, as illustrated by the other arrow in FIG. 8F, so that concave surfaces 35b and 61 of femoral component 20 and modular housing 60, respectively, come together to form transverse opening 65. At this point, locking screw 73 is advanced into femoral component 20 causing concave surface 71 of wedge body 76 to come into contact with convex surface 62 of hinge housing 60 and rib 67 to be received within groove 77. Further tightening of screw 73 causes locking wedge 70 to apply a compressive force on hinge housing 60 to secure it in place within femoral component 20.
Thereafter, bone cement is applied between hinge housing 60 and the underlying bone that was just resected. In this regard, bone cement nozzle 90 is introduced into transverse bore 65 of the axle housing, as shown in FIG. 7C. The diameters of the first and second cylindrical portions 95a-b of the nozzle 90 are substantially equal to the diameter of transverse bore 65 of femoral component 20″ thereby creating a barrier for the egress of the cement. Pressurization of the cement with the cement gun causes the cement to travel through internal passage 97 of nozzle 90, out through the outlet aperture 98b and through apertures 63 of axle housing 60. Bone cement is thereby delivered and pressurized in the space between axle housing 60 and the adjacent bone. Grooves 64 on axle housing 60 provide interlocking features for the bone cement. Upon delivery of the cement, nozzle 90 is removed, placed on the opposite condyle and the process repeated. Second cylindrical portion 95b of nozzle 90 clears or “squeegees” the cement out of the bore upon removal of thereof thus providing an unobstructed bore 65 for the insertion of axle 100 and corresponding axle bushings 102a-b.
Axle bushings 102a-b are then inserted into transverse opening 65. Second tibial assembly 80 is connected to a proximal end of the tibia such that head 85 of assembly 80 extends proximally therefrom. Head 85 is inserted into intercondylar recess 31 such that the axle opening thereof aligns with transverse opening 65 of hinge configured femoral component 20″. Axle 100 is then inserted into transverse opening 65, bushings 102a-b, and the axle opening of head 85 so as to connect second tibial assembly 80 with hinge configured femoral component 20″. In this regard, base femoral component 20 was converted from a TS configuration or mode to a more constrained hinge configuration or mode in situ without removing base femoral component 20 from the distal femur. As such, this procedure is performed more quickly than a typical revision procedure and without disrupting the underlying bone.
It should be understood that TS configured femoral component 20′ can be preassembled by the manufacturer prior to delivery to the operating room or it can be assembled in the operating room by the surgical team. In this regard, TS configured femoral component is assembled in the reverse order from its disassembly. As such, a first box locking housing 40a is passed through intercondylar recess 31 and slid laterally or medially partial housing 37 so that convex 42 surface engages concave surface 34a of housing 37. Box locking housing 40 is slid until it abuts interlocking feature 34a. This is repeated for second box locking housing 40b, as can be visualized by FIG. 8E.
Thereafter, modular cam box 50 is inserted into intercondylar recess 31 between box locking housings 40a-b so that strut 36 is received within slot 51, abutment face abuts 56 partial box walls 29a-b, and apertures 52 align with openings 44 of locking housings 40a-b, as can be visualized by FIG. 8B.
Once modular cam box 50 is in its final seated position, locking screws 45 are threaded into their respective locking housings 50 so that non-threaded posts 46 are received within apertures 52 of modular box 50 to secure it to femoral component 20. Once femoral component 20 is assembled with modular cam box 50 and locking housings 40a-b, TS configured femoral component 20′ is ready to be implanted onto a femur, which is resected so as to have a corresponding number of resected surfaces as that of inner surfaces 21-24 of femoral component 20′. TS femoral component 20′ is then implanted onto the distal femur and connected with first tibial assembly (200, 210) so that post 202 can articulate with cam surface 59.
FIG. 9A depicts a femoral component 120 according to another embodiment of the present disclosure. Femoral component 120 is a monolithic body that generally includes a bone facing side, an articular side, and lateral and medial articular portions 132a-b. Lateral and medial condylar portions 132a-b are separated by an intercondylar recess or notch 131. A transverse opening or transverse through-bore 125 extends through a posterior aspect of the lateral and medial condylar portions 132a-b and intersects intercondylar recess 131 such that transverse opening 125 is split by recess into lateral and medial transverse openings 125a-b. In this regard, openings 125a-b are aligned such that they are concentric with each other and form concavely curved surfaces in the shape of a cylinder that extend across lateral and medial condylar portions 132a-b. In addition, transverse opening 125, unlike in femoral component 20, is completely defined by the structure of the monolithic body of femoral component 120, rather than being at least partially defined by modular components that are connected thereto. Femoral component 120 also includes locking ring grooves 126 that are concentric with opening 125 and positioned at the lateral extent of lateral opening 125a and/or medial extent of medial opening 125b.
The bone facing side includes intersecting inner bone facing surfaces 121, 122, 123, and 124. Typically TKA femoral components include five inner bone facing surfaces each corresponding with one of a posterior, anterior, distal, anterior chamfer, and posterior chamfer resected surfaces of a distal femur. While a femoral component may have five of such inner surfaces, femoral component 120 preferably includes four inner bone facing surfaces 121-124 in order to allow for femoral component 120 to have sufficient thickness at a posterior portion thereof for transverse openings 125a-b to extend therethrough. In this regard, a femur is resected to correspond to such inner surfaces 121-124. However, in some embodiments, the bone facing side may have only three bone facing surfaces which would also provide sufficient space to extend opening 125 through the posterior aspect of femoral component. However, four inner bone facing surfaces is preferred because it allows for less bone removal than three inner surfaces while providing for more space for transverse opening 125 than five or more inner surfaces.
The bone facing side also includes a cam box 127 and a stem boss 128. Cam box 127 extends superiorly from femoral component 120. In particular, cam box 127, as shown, interrupts and extends from bone facing surfaces 121-123. However, cam box 127 may extend from any combination of bone facing surfaces 121-124. Cam box 127 is generally more fully formed in the monolithic structure of base femoral component 120 than partial box 27 of femoral component 20 in so far as cam box 127 extends entirely from surface 121 to surface 123 without the use of modular components. However, similar to femoral component 20, cam box 127 utilizes modular components to provide a cam surface that is configured to articulate with a post of a tibial insert, as described further below. Stem boss 128 extends superiorly from cam box 127 and may include an opening therein for receipt of a modular stem (not shown). However, in some embodiments, stem boss 128 may instead be an integral stem incorporated into the structure of femoral component 120. The bone facing side may include a porous material, such as titanium foam and the like for promoting bone ingrowth, such as when femoral component 120 is press-fit to a femur. However, the bone facing side may instead include solid surfaces for instances in which femoral component 120 is cemented to a femur.
As indicated above, femoral component 120 can be used in various TKA configurations. In particular, femoral component 120 can be converted in situ from a TS configuration to a hinge configuration. This allows femoral component 120 to remain affixed to a distal femur in a revision procedure so that instability issues can be addressed by such conversion without the further complication of having to remove femoral component 120 and to resect or otherwise prepare the distal femur for a separate femoral component. Thus, femoral component 120 helps save time in the operating room as well as helps spare bone and potential complications of removing a well affixed prosthesis from underlying bone.
FIGS. 9B and 9C depict femoral component 120 in a TS configuration or TS mode. In this regard, the additional modular components provided in such configuration allow femoral component to be configured for articulation with a post of a tibial insert, such as post 202 of insert 200. Included in this configuration is a cam member or first modular component 140, a cam locking member/axle or second modular component 150, and a locking ring 160.
Cam member 140 is sized and shaped to fit into recess 161 between lateral and medial condylar portions 132a-b and span across recess 131 so as to engage with lateral and medial condylar portions 132a-b. Cam member 140 is intersected by a cam notch or recess 142 which defines a cam portion 141 and opposing lateral and medial tabs or walls 145a-b. Cam member 140 defines a transverse opening 146 that extends laterally-medially through tabs 145a-b and intersects cam recess 142. A longitudinal groove 144 also extends laterally-medially along a superior side of opening 146 such that groove 144 communicates with opening 146. Such groove 144 is configured to slidingly receive a protrusion 154 of cam locking member 150 therein, as described below. Cam member 140 also defined an inferior surface that is a cam surface configured to articulate with a post of a tibial insert, such as post 202, and a superior surface that abuts a corresponding surface in cam box 127 to complete the box. Tabs 145a-b include a keying feature 148 that is shown as teeth or a series of ledges that extend superiorly from one or more of tabs 145a-b. Keying feature 148 allows cam member 140 to engage a corresponding keying feature (not shown) of femoral component 120 so that cam member 140 can engage femoral component 120 in the desired orientation.
Cam locking member 150 has first and second members 151, 152. First member 151 is shown as a hollow cylinder and is dimensioned to be received in either transverse opening 125a or 125b. Second portion 152 extends from first member 151 along a longitudinal axis of cam locking axle 150 and is integral therewith such that first and second members form a monolithic structure. Second portion 152 has a cylindrical profile similar to that of first member 151. However, second portion 152 is machined so that it has a protrusion or rail 154 extending laterally-medially along a length thereof. Such protrusion 154 is configured to be received within groove 144 of cam member 140. Cam axle 150 is also machined to have a recess or notch 156 that corresponds to the recess/notch 142 of cam member 140 so as to effectively become an extension of cam surface 141 of cam member 140 when cam axle 150 is engaged to cam member 140. Thus, when second portion 152 of locking mechanism 150 is positioned within cam member 140, locking mechanism 150 completes cam surface 141 of cam 140 so that such surface 141 is virtually seamless. Cam locking axle 150 is locked into place by locking ring 160 which is configured to be received within locking ring groove 126.
As assembled in the TS configuration, cam member 140 is positioned within recess 131 such that first tab 145a engages lateral condylar portion 132a and second tab 145b engages medial condylar portion 132b. In this regard, cam surface extends across recess, as best shown in FIG. 9C. Moreover, the keying features engage each other such that camming surface 141 is in the appropriate orientation for articulation. In order to lock cam member 140 to femoral component 120, first portion 152 of cam locking axle 150 is positioned within opening 125a within lateral condylar portion 132a of femoral component 120. However, it should be understood that first member 151 can be received within opening 125b in medial condyle. Locking ring 160 is positioned in locking ring groove 126 adjacent to first member 151 but lateral thereto so as to prevent locking axle 150 from moving laterally out of opening 125a. In this position, second portion 152 is positioned within opening 146 of cam member 140 such that protrusion 154 is slideably disposed within recess 144. In this regard, protrusion 154 prevents locking axle 150 and cam member 140 from rotating relative to each other. Moreover, locking axle 150 prevents cam member 140 from moving relative to femoral component 120, thereby securing it in place.
Femoral component 120 can be converted from the TS configuration to a hinge configuration in situ. However, it so happens that femoral component 120's default configuration is the hinge configuration. In this regard, femoral component 120 as depicted in FIG. 9A is in the hinge mode and no modular components are needed to convert femoral component 120 to the hinge mode once hinge member 140, locking axle 150, and locking ring 160 are removed. Thus, femoral component 120 as shown in FIG. 9A can be connected straight away to a tibial assembly via an axle. Such tibial assembly is shown is depicted in FIG. 9D and may be identical to that of assembly 80. As such, the tibial assembly includes a bearing component 170, axle 110, axle bushings 180, and a bumper 190, as shown, and also a tibial baseplate component and insert, such as baseplate component 81 and insert 86. Bearing component 170 includes an articular surface 174 for articulation with the tibial insert and a bearing shaft 171 that extends into the tibial baseplate component.
FIGS. 9E and 9F depict femoral component 120 in the hinge configuration assembled with a corresponding tibial assembly. In this regard, axle 110 is positioned through an axle opening 178a of bearing member 170 and also through transverse openings 125a-b of femoral component 120. Bushings 180a-b are positioned over axle 110 at respective lateral and medial ends thereof and within transverse openings 125a-b. A post 194 of bumper 190 is located within a post opening 178b within head 176 so as to limit hyperextension of femoral component 120 relative to the tibial assembly.
Currently, if a patient has a TS implant which is unstable due to collateral ligament deficiencies, a conversion to a hinged device may be recommended. However, existing TS femoral and tibial implants must be removed in order to perform this conversion. The convertible prosthesis assembly described above allows the surgeon to leave a well fixed, well aligned femoral component 120 in place and still convert femoral component 120 to the hinged configuration.
In this regard, a method of such conversion is now described. In the method, femoral component 120 is preferably preassembled in the TS configuration prior to implantation of the same. In this regard, cam member 140 is inserted into recess 131 of femoral component 120. Cam locking axle 150 is then inserted into opening 125 of femoral component 120 and also opening 146 of cam member 140 such that protrusion 154 is received by groove 144. Thereafter, locking ring 160 is inserted into locking ring groove 126 within opening 125a. However, this assembly can also be done in the operating room. Femoral component 120 in the TS configuration can then be implanted onto a distal end of a femur. As such, the femur may be resected such that it has four resected surfaces to correspond with inner surfaces 121-124 of femoral component 120. After, this initial procedure, which itself may be a revision procedure, the patient may develop instability requiring a revision procedure or a further revision procedure to convert to a hinge prosthesis.
In the revision procedure, the operator gains access to the previously implanted prosthesis via a standard incision. The tibial insert, such as insert 200, is disconnected from femoral component 120. Thereafter, locking ring 160 is removed to allow cam locking axle 150 to slide out of opening 146 of cam member 140 and opening 125a of femoral component 120. This may require an impaction instrument to assist in the removal of locking axle 150. Once cam locking axle 150 is removed, cam member 140 can be removed from recess 131 of femoral component 120. Femoral component 120 remains in place on the distal femur during while such disassembly is performed.
At this point femoral component 120 is in the hinge mode and is, therefore, ready to be assembled with a tibial assembly. In this regard, axle bushings 180a-b are inserted into respective transverse openings 125a-b of femoral component 120 such that flanges 182 are opposite each other and are disposed on the inside of their respective condylar portion 132a-b such that the flanges are at the opposite ends of openings 125a-b relative to locking ring recess 126. Femoral component 120 is then mounted onto bearing component 170 such that head portion 176 extends into recess 131 adjacent flanges 182. Once second opening 178a of bearing component 170 is aligned with axle openings 125a-b, axle 110 is inserted into openings 178a and 125a-b, thereby coupling femoral component 120 to the tibial assembly.
While the foregoing description describes femoral components 20 and 120, which can be converted in situ from a TS configuration to a hinge configuration, it is also contemplated that a tibial assembly connectable thereto can also be converted from a TS configuration to a hinge configuration in situ. For example, baseplate component 81 of FIG. 6D may be utilized in a TS procedure in lieu of baseplate 210 of FIG. 4E. However, insert 200 could be connected to baseplate 81 to operate with femoral component 20 or 120 in their respective TS configurations. Thus, when converted to a hinge configuration, tibial baseplate 81 need not be removed from the patient's tibia. Instead, insert 200 can be disconnected from baseplate 81 and then bearing component 84 or 170 and insert 86 can be coupled to baseplate component 81. Thus, a first tibial assembly may include baseplate component 81 and insert 200, and a second tibial assembly may include baseplate component 81, bearing component 84 or 170, and insert 86.
In addition, while the tibial assemblies described herein include a bearing component 81, 170 that articulates with a respective tibial insert, such as insert 86, it should be understood that the femoral components described herein can be connected to other tibial assemblies that utilize an axle, such as axles 100 and 110. In this regard, it is contemplated that femoral components 20 and 120 can articulate directly with a tibial insert of a hinge prosthesis while also being connected to an axle. As such, a tibial assembly that connects to the femoral components described herein, while in their respective hinge configurations, may not include a bearing component or at least a bearing component that itself has a portion that articulates with a tibial insert.
Furthermore, while the foregoing description describes a system that can convert from a TS configuration to a hinge configuration, it is also contemplated that the system can convert from a PS configuration to a hinge configuration. In this regard, a PS femoral component would be the same as the TS component with the difference being that the PS femoral component would not include a stem boss or intramedullary stem and would instead include pegs that extend superiorly from a bone facing side thereof as is known. While a PS-to-hinge conversion is contemplated, it is more desirable for a TS-to-hinge conversion so that the intramedullary stem can help support the hinge configuration.
Although the invention herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present invention. It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present invention as defined by the appended claims.
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16924598
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howmedica osteonics corp.
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USA
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B2
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Utility Patent Grant (with pre-grant publication) issued on or after January 2, 2001.
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Open
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Apr 27th, 2022 09:01AM
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Apr 27th, 2022 09:01AM
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Stryker
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Health Care
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Health Care Equipment & Services
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nyse:syk
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Stryker
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Apr 26th, 2022 12:00AM
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Feb 22nd, 2019 12:00AM
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https://www.uspto.gov?id=US11311392-20220426
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Modular femoral trialing system permitting relative movement
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An assembly for attachment to a first implant component has a size and shape of a second implant component to be implanted together with the first implant component. The assembly includes a first body and a second body removably connected to the first body. In a temporary configuration, the first and second bodies are prevented from separating while the first and second bodies permit relative movement therebetween. A modular kit includes a plurality of the first bodies each having a different size or shape, and a plurality of the second bodies each having a different size or shape. A method of assembling the assembly includes removably connecting the first body to the second body, such that the first and second bodies are prevented from separating while permitting relative movement therebetween, and positioning the assembly on the first implant component.
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11311392
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1. An assembly for attachment to a first implant component, the assembly having a size and shape of a second implant component to be implanted together with the first implant component, comprising:
a first body; and
a second body removably connectable to the first body;
the first body defines a recess and the second body includes a protrusion insertable into the recess;
the protrusion includes a terminal end and an external surface defining a non-threaded portion and defining a threaded portion that is located closer to the terminal end of the protrusion than its non-threaded portion is; and
the recess includes a terminal end and an internal surface defining a non-threaded portion and defining a threaded portion that is located closer to the terminal end of the recess than it's non-threaded portion is;
wherein in a temporary configuration, when the second body is removably connected to the first body, the first and second bodies are prevented from separating while the first and second bodies permit relative movement therebetween; and
when the assembly is in the temporary configuration, the entire threaded portion of the protrusion is located within the recess past the threaded portion of the recess.
2. The assembly of claim 1, wherein the first and second bodies are connectable along an axis, and the relative movement is translational along the axis.
3. The assembly of claim 1, wherein the first and second bodies are connectable along an axis, and the relative movement is rotational about the axis.
4. The assembly of claim 1, wherein the first and second bodies are connectable along an axis, and the relative movement is translational along the axis and rotational about the axis.
5. The assembly of claim 1, wherein the threaded portions of the protrusion and the recess engage one another as the protrusion is inserted into the recess.
6. The assembly of claim 1, wherein the protrusion includes an anti-rotation portion at a base end opposite its terminal end that has a non-circular cross section, and the recess includes an anti-rotation portion at its terminal end that has a non-circular cross section.
7. The assembly of claim 1, wherein in a fixed configuration, the first and second bodies are prevented from separating while relative movement is not permitted between the first and second bodies.
8. A system comprising Tthe assembly of claim 7, a first implant component, and a locking screw, wherein in the fixed configuration, the locking screw is secured through the first body and the second body and into a portion of the first implant component.
9. The system of claim 8, wherein the first and second bodies are connectable along an axis and each define lumens aligned with the axis in which the locking screw can be disposed.
10. A method of assembling the assembly of claim 1 for attachment to a first implant component, the method comprising the steps of:
removably connecting the first body of the assembly to the second body of the assembly, such that the first and second bodies are prevented from separating while permitting relative movement therebetween; and
positioning the assembly on the first implant component.
11. An assembly for attachment to a first implant component, the assembly having a size and shape of a second implant component to be implanted together with the first implant component, comprising:
A first body; and
A second body removably connectable to the first body;
The first body defines a recess and the second body includes a protrusion insertable into the recess:
The protrusion includes a terminal end and an external surface defining a non-threaded portion and defining a threaded portion that is located closer to the terminal end of the protrusion than its non-threaded portion is; and
the recess includes a terminal end and in internal surface defining a non-threaded portion and defining a threaded portion that is located closer to the terminal end of the recess than its non-threaded portion is; and
wherein when the assembled together, the first and second bodies correspond to a cone body of a femoral hip assembly as the second implant component.
12. The assembly of claim 11, wherein the first body defines a femoral neck and an upper portion of a trunk of the cone body, and the second body defines a lower portion of the trunk of the cone body.
13. The assembly of claim 12, wherein:
the upper and lower portions of the trunk of the cone body are connectable along a first axis, and the femoral neck of the first body extends along a second axis that is angled with respect to the first axis;
the trunk defines a maximum outer diameter;
the trunk defines a maximum height; and
the femoral neck has a conical proximal surface for connecting with a femoral head, the conical proximal surface defining a center point of the proximal neck, and wherein the first body defines an offset distance measured perpendicularly from the first axis to the center point.
14. A modular femoral trialing kit, comprising:
a plurality of the first bodies according to claim 13, each having a different size or shape; and
a plurality of the second bodies according to claim 13, each having a different size or shape.
15. The kit of claim 14, wherein the maximum outer diameter of the trunk is provided in sizes of 17, 19, 21, 23, 25, 27, 29, and 31 mm.
16. The kit of claim 14, wherein the maximum height of the trunk is provided in sizes of 50, 60, 70, 80, 90, and 100 mm.
17. The kit of claim 14, wherein the offset distance of the femoral neck is provided in sizes of 30, 34, 36, 38, 40, and 44 mm.
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17
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BACKGROUND OF THE INVENTION
The present disclosure relates to trialing systems for prosthetic implants. More particularly, the present disclosure relates to modular trialing systems including components that can be temporarily and fixedly connected during a trialing procedure and methods of conducting a trialing procedure using such systems.
In current femoral revision systems, a proximal body and distal stem are implanted into the patient. In order to properly analyze the fit of the final implant, a trial of the proximal body is attached to the distal stem. The joint is then reduced and evaluated. If another size implant would better fit the anatomy of the patient, the trial of the proximal body is replaced with a differently sized trial, and the process is repeated. Once the proper fit is found, a permanent proximal body is located that corresponds to the proper trial.
Current trials corresponding to the proximal body are one-piece, monolithic structures, such as the proximal body 80 shown in FIG. 1 having a trunk and a femoral neck. The femoral neck has a conical proximal surface at its terminal end for connecting with a trial femoral head. The conical proximal surface defines a center point corresponding to that of an implanted femoral head. Each trial corresponds to just one permanent implant, and vice versa. Thus, a tray of trials equaling the number of unique permanent implants is required to perform each surgical procedure. Trials are typically the most expensive components in the trialing set, accounting for approximately 40% of the total cost of the system. Accordingly, New sizes of implants increase set cost and increase tray size.
As shown in FIG. 1, each proximal body 80 is unique in one or more parameters, including a maximum outer diameter 82 of its trunk, a maximum height 84 of its trunk, and an offset distance 86 measured perpendicularly from the axis of the trunk to the center point of the conical proximal surface of the femoral neck, which coincides with a center point of the corresponding femoral head.
A modular trialing system is needed that improves the efficiency of trialing procedures and reduces the cost and number of components in a trialing set.
BRIEF SUMMARY OF THE INVENTION
A first aspect of the present invention is an assembly for attachment to a first implant component, the assembly having a size and shape of a second implant component to be implanted together with the first implant component, including a first body, and a second body removably connected to the first body, wherein in a temporary configuration, the first and second bodies are prevented from separating while the first and second bodies permit relative movement therebetween.
In accordance with other embodiments of the first aspect, in a fixed configuration, the first and second bodies may be prevented from separating while relative movement is not permitted between the first and second bodies. The assembly may further include a locking screw, and in the fixed configuration, the locking screw may be secured through the first body and the second body and into a portion of the first implant component.
The first and second bodies may be connectable along an axis and may each define lumens aligned with the axis in which the locking screw can be disposed. The first and second bodies may be connectable along an axis, and the relative movement may be translational along and/or rotational about the axis. A modular kit may include a plurality of the first bodies as defined above each having a different size or shape, and a plurality of the second bodies as defined above each having a different size or shape. The kit may further include a permanent implant component having the same dimensions as the assembly.
The first body may define a recess and the second body may include a protrusion insertable into the recess. The protrusion may include a terminal end and an external surface defining a non-threaded portion and defining a threaded portion that is located closer to the terminal end of the protrusion than its non-threaded portion is, and the recess may include a terminal end and an internal surface defining a non-threaded portion and defining a threaded portion that is located closer to the terminal end of the recess than its non-threaded portion is. When the assembly is in the temporary configuration, the entire threaded portion of the protrusion may be located within the recess past the threaded portion of the recess. The threaded portions of the protrusion and the recess may engage one another as the protrusion is inserted into the recess. The protrusion may include an anti-rotation portion at a base end opposite its terminal end that has a non-circular cross section, and the recess may include an anti-rotation portion at its terminal end that has a non-circular cross section. The non-circular cross sections may be square cross sections.
When assembled together, the first and second bodies may correspond to a cone body of a femoral hip assembly as the second implant component. The first body may define a femoral neck and an upper portion of a trunk of the cone body, and the second body may define a lower portion of the trunk of the cone body. The upper and lower portions of the trunk of the cone body may be connectable along a first axis, and the femoral neck of the first body may extend along a second axis that is angled with respect to the axis. The trunk may define a maximum outer diameter, the second body may define a maximum height, and the femoral neck may have a conical proximal surface for connecting with a femoral head, the conical proximal surface defining a center point of the proximal neck, and wherein the first body defines an offset distance measured perpendicularly from the axis to the center point. A modular femoral trialing kit may include a plurality of the first bodies as defined above each having a different size or shape, and a plurality of the second bodies as defined above each having a different size or shape. The maximum outer diameter of the trunk may be provided in sizes of 17, 19, 21, 23, 25, 27, 29, and 31 mm The maximum height of the second body may be provided in sizes of 50, 60, 70, 80, 90, and 100 mm The offset distance of the femoral neck may be provided in sizes of 30, 34, 36, 38, 40, and 44 mm The kit may further include a locking screw for securing the first body to the second body on a portion of an implant.
A second aspect of the present invention is a method of assembling an assembly for attachment to a first implant component, the assembly having a size and shape of a second implant component to be implanted together with the first implant component, including the steps of removably connecting a first body of the assembly to a second body of the assembly, such that the first and second bodies are prevented from separating while permitting relative movement therebetween, and positioning the assembly on the first implant component.
In accordance with other embodiments of the second aspect, the method may further include the step of fixedly connecting the first body to the second body together by securing the assembly to the first implant component to prevent relative movement between the first and second bodies. The step of fixedly connecting may include securing a locking screw through the first body and the second body and into a portion of the first implant component. The method may further include the step of assessing the biomechanics of a joint with the implanted assembly. The step of removably connecting may include permitting relative movement translationally along and/or rotationally about an axis along which the first and second bodies are connectable.
The step of removably connecting may include inserting a protrusion of the second body into a recess defined by the first body. The step of removably connecting may include threading a threaded portion defined by an external surface of the protrusion into engagement with a threaded portion defined by an internal surface of the recess, and further threading the threaded portion of the protrusion until the entire threaded portion of the protrusion is located within the recess past the threaded portion of the recess. The method may further include the step of fixedly connecting the first body to the second body together by securing the assembly to the first implant component to prevent relative movement between the first and second bodies, including preventing rotation of the first body with respect to the second body by engaging an anti-rotation portion at a base end of the protrusion that has a non-circular cross section with an anti-rotation portion at a terminal end of the recess that has a non-circular cross section.
The method may further include the step of selecting the second implant component having the same dimensions as the assembly. The method may further include the steps of selecting the first body from a kit including a plurality of the first bodies each having a different size or shape, and selecting the second body from the kit including a plurality of the second bodies each having a different size or shape.
A third aspect of the present invention is an assembly for attachment to a first implant component, the assembly having a size and shape of a second implant component to be implanted together with the first implant component, including a first body defining a recess, the recess having an internal surface defining an annular groove, a second body including a protrusion insertable into the recess, the protrusion having an external surface defining an annular groove, and a split ring, wherein, when the split ring is disposed at least partially within the annular grooves of the protrusion and the recess, the first and second bodies are removably connected such that the first and second bodies are prevented from separating.
In accordance with other embodiments of the third aspect, the assembly may further include a locking screw configured to be secured through the first body and the second body and into a portion of the first implant component. The first and second bodies may be connectable along an axis and may each define lumens aligned with the axis in which the locking screw can be disposed. Tabs on one of the recess and the protrusion may be disposed within indents on the other of the recess and the protrusion to prevent relative rotation between the first and second bodies. A modular kit may include a plurality of the first bodies as defined above each having a different size or shape, and a plurality of the second bodies as defined above each having a different size or shape. The kit may further include a permanent implant component having the same dimensions as the assembly.
When assembled together, the first and second bodies may correspond to a cone body of a femoral hip assembly as the second implant component. The first body may define a femoral neck and an upper portion of a trunk of the cone body, and the second body may define a lower portion of the trunk of the cone body. The upper and lower portions of the trunk of the cone body may connectable along a first axis, and the femoral neck of the first body may extend along a second axis that is angled with respect to the axis. The trunk may define a maximum outer diameter, the second body may define a maximum height, and the femoral neck may have a conical proximal surface for connecting with a femoral head, the conical proximal surface defining a center point of the proximal neck, and wherein the first body defines an offset distance measured perpendicularly from the axis to the center point. A modular femoral trialing kit may include a plurality of the first bodies as defined above each having a different size or shape, and a plurality of the second bodies as defined above each having a different size or shape. The maximum outer diameter of the trunk may be provided in sizes of 17, 19, 21, 23, 25, 27, 29, and 31 mm The maximum height of the second body may be provided in sizes of 50, 60, 70, 80, 90, and 100 mm The offset distance of the femoral neck may be provided in sizes of 30, 34, 36, 38, 40, and 44 mm The kit may further include a locking screw for securing the first body to the second body on a portion of an implant.
A fourth aspect of the present invention is a method of assembling an assembly for attachment to a first implant component, the assembly having a size and shape of a second implant component to be implanted together with the first implant component, including the steps of removably connecting a protrusion of a second body of the assembly into a recess defined by a first body of the assembly to move a split ring at least partially into an annular groove defined in an external surface of the protrusion and at least partially into an annular groove defined in an internal surface of the recess, such that the first and second bodies are prevented from separating, and positioning the assembly on the first implant component.
In accordance with other embodiments of the fourth aspect, the method may further include the step of fixedly connecting the first body to the second body together by securing a locking screw through the first body and the second body and into a portion of the first implant component. The method may further include the step of assessing the biomechanics of a joint with the implanted assembly. The step of removably connecting may further include inserting tabs on one of the recess and the protrusion within indents on the other of the recess and the protrusion to prevent relative rotation between the first and second bodies. The method may further include the step of selecting the second implant component having the same dimensions as the assembly. The method may further include the steps of selecting the first body from a kit including a plurality of the first bodies each having a different size or shape, and selecting the second body from the kit including a plurality of the second bodies each having a different size or shape.
A first aspect of the present invention is an assembly for attachment to a first implant component, the assembly having a size and shape of a second implant component to be implanted together with the first implant component, including a first body and a second body removably connectable to the first body, wherein in a temporary configuration, when the second body is removably connected to the first body, the first and second bodies are prevented from separating while the first and second bodies permit relative movement therebetween.
In accordance with other embodiments of the first aspect, in a fixed configuration, the first and second bodies may be prevented from separating while relative movement is not permitted between the first and second bodies. The assembly may further include a locking screw, and in the fixed configuration, the locking screw may be secured through the first body and the second body and into a portion of the first implant component. The first and second bodies may be connectable along an axis and each may define lumens aligned with the axis in which the locking screw can be disposed. The first and second bodies may be connectable along an axis, and the relative movement may be translational along the axis and/or rotational about the axis.
The first body may define a recess and the second body may include a protrusion insertable into the recess. The protrusion may include a terminal end and an external surface defining a non-threaded portion and defining a threaded portion that is located closer to the terminal end of the protrusion than its non-threaded portion is, and the recess may include a terminal end and an internal surface defining a non-threaded portion and defining a threaded portion that is located closer to the terminal end of the recess than its non-threaded portion is. When the assembly is in the temporary configuration, the entire threaded portion of the protrusion may be located within the recess past the threaded portion of the recess. The threaded portions of the protrusion and the recess may engage one another as the protrusion is inserted into the recess. The protrusion may include an anti-rotation portion at a base end opposite its terminal end that has a non-circular cross section, and the recess may include an anti-rotation portion at its terminal end that has a non-circular cross section. The non-circular cross sections may be square cross sections.
When assembled together, the first and second bodies may correspond to a cone body of a femoral hip assembly as the second implant component. The first body may define a femoral neck and an upper portion of a trunk of the cone body, and the second body may define a lower portion of the trunk of the cone body. The upper and lower portions of the trunk of the cone body may be connectable along a first axis, and the femoral neck of the first body may extend along a second axis that is angled with respect to the first axis. The trunk may define a maximum outer diameter and a maximum height, and the femoral neck may have a conical proximal surface for connecting with a femoral head, the conical proximal surface defining a center point of the proximal neck, and wherein the first body defines an offset distance measured perpendicularly from the first axis to the center point.
A modular femoral trialing kit may include a plurality of the first bodies according to the above, each having a different size or shape, and a plurality of the second bodies according to the above, each having a different size or shape. The maximum outer diameter of the trunk may be provided in sizes of 17, 19, 21, 23, 25, 27, 29, and 31 mm, or in other sizes. The maximum height of the trunk may be provided in sizes of 50, 60, 70, 80, 90, and 100 mm, or in other sizes. The offset distance of the femoral neck may be provided in sizes of 30, 34, 36, 38, 40, and 44 mm, or in other sizes. The kit may further include a locking screw for securing the first body to the second body on a portion of an implant.
A second aspect of the present invention is a method of assembling an assembly for attachment to a first implant component, the assembly having a size and shape of a second implant component to be implanted together with the first implant component, including the steps of removably connecting a first body of the assembly to a second body of the assembly, such that the first and second bodies are prevented from separating while permitting relative movement therebetween, and positioning the assembly on the first implant component.
In accordance with other embodiments of the second aspect, the method may further include the step of fixedly connecting the first body to the second body together by securing the assembly to the first implant component to prevent relative movement between the first and second bodies. The step of fixedly connecting may include securing a locking screw through the first body and the second body and into a portion of the first implant component. The method may further include the step of assessing the biomechanics of a joint with the implanted assembly.
The step of removably connecting may include permitting relative movement translationally along an axis along which the first and second bodies are connectable. The step of removably connecting may include permitting relative movement rotationally about an axis along which the first and second bodies are connectable. The step of removably connecting may include permitting relative movement translationally along and rotationally about an axis along which the first and second bodies are connectable.
The step of removably connecting may include inserting a protrusion of the second body into a recess defined by the first body. The step of removably connecting may include threading a threaded portion defined by an external surface of the protrusion into engagement with a threaded portion defined by an internal surface of the recess, and further threading the threaded portion of the protrusion until the entire threaded portion of the protrusion is located within the recess past the threaded portion of the recess. The method may further include the step of fixedly connecting the first body to the second body together by securing the assembly to the first implant component to prevent relative movement between the first and second bodies, including preventing rotation of the first body with respect to the second body by engaging an anti-rotation portion at a base end of the protrusion that has a non-circular cross section with an anti-rotation portion at a terminal end of the recess that has a non-circular cross section.
The method may further include the step of selecting a permanent implant component having the same dimensions as the assembly. The method may further include the steps of selecting the first body from a kit including a plurality of the first bodies each having a different size or shape, and selecting the second body from the kit including a plurality of the second bodies each having a different size or shape.
A third aspect of the present invention is an assembly for attachment to a first implant component, the assembly having a size and shape of a second implant component to be implanted together with the first implant component, including a first body defining a recess, the recess having an internal surface defining an annular groove, a second body including a protrusion insertable into the recess, the protrusion having an external surface defining an annular groove, and a split ring, wherein, when the split ring is disposed at least partially within the annular grooves of the protrusion and the recess, the first and second bodies are removably connected such that the first and second bodies are prevented from separating.
In accordance with other embodiments of the third aspect, the assembly may further include a locking screw configured to be secured through the first body and the second body and into a portion of the first implant component. The first and second bodies may be connectable along an axis and each may define lumens aligned with the axis in which the locking screw can be disposed. Tabs on one of the recess and the protrusion may be disposed within indents on the other of the recess and the protrusion to prevent relative rotation between the first and second bodies.
When assembled together, the first and second bodies may correspond to a cone body of a femoral hip assembly as the second implant component. The first body may define a femoral neck and an upper portion of a trunk of the cone body, and the second body may define a lower portion of the trunk of the cone body. The upper and lower portions of the trunk of the cone body may be connectable along a first axis, and the femoral neck of the first body may extend along a second axis that is angled with respect to the first axis. The trunk may define a maximum outer diameter and a maximum height, and the femoral neck may have a conical proximal surface for connecting with a femoral head, the conical proximal surface defining a center point of the proximal neck, and wherein the first body may define an offset distance measured perpendicularly from the first axis to the center point.
A modular femoral trialing kit may include a plurality of the first bodies according to the above, each having a different size or shape, and a plurality of the second bodies according to the above, each having a different size or shape. The maximum outer diameter of the trunk may be provided in sizes of 17, 19, 21, 23, 25, 27, 29, and 31 mm, or in other sizes. The maximum height of the trunk may be provided in sizes of 50, 60, 70, 80, 90, and 100 mm, or in other sizes. The offset distance of the femoral neck may be provided in sizes of 30, 34, 38, 40, and 44 mm, or in other sizes. The kit may further include a locking screw for securing the first body to the second body on a portion of an implant.
A fourth aspect of the present invention is a method of assembling an assembly for attachment to a first implant component, the assembly having a size and shape of a second implant component to be implanted together with the first implant component, including the steps of removably connecting a protrusion of a second body of the assembly into a recess defined by a first body of the assembly to move a split ring at least partially into an annular groove defined in an external surface of the protrusion and at least partially into an annular groove defined in an internal surface of the recess, such that the first and second bodies are prevented from separating, and positioning the assembly on the first implant component.
In accordance with other embodiments of the fourth aspect, the method may further include the step of fixedly connecting the first body to the second body together by securing a locking screw through the first body and the second body and into a portion of the first implant component. The method may further include the steps of assessing the biomechanics of a joint with the implanted assembly. The step of removably connecting may further include inserting tabs on one of the recess and the protrusion within indents on the other of the recess and the protrusion to prevent relative rotation between the first and second bodies. The method may further include the step of selecting a permanent implant component having the same dimensions as the assembly. The method may further include the steps of selecting the first body from a kit including a plurality of the first bodies each having a different size or shape, and selecting the second body from the kit including a plurality of the second bodies each having a different size or shape.
A fifth aspect of the present invention is an assembly for attachment to a first implant component, the assembly having a size and shape of a second implant component to be implanted together with the first implant component, including a first body defining a protrusion, and a second body including a recess into which the protrusion is insertable, wherein, when the protrusion is seated within the recess, the first and second bodies are removably connected such that the first and second bodies are prevented from separating.
In accordance with other embodiments of the fifth aspect, the assembly may further include a locking screw configured to be secured through the first body and the second body and into a portion of the first implant component. The first and second bodies may be connectable along a first axis and each may define lumens aligned with a second axis in which the locking screw can be disposed, the second axis being substantially perpendicular to the first axis. The protrusion may include a spring arm that presses against an internal wall of the recess when the protrusion is seated within the recess to prevent the first and second bodies from separating. The spring arm may include a convexly curved surface and the internal wall may be a concavely curved surface. The protrusion may include two spring arms that press against opposing internal walls, respectively, of the recess when the protrusion is seated within the recess to prevent the first and second bodies from separating. The two spring arms may include opposing convexly curved surfaces and the opposing internal walls may be opposing concavely curved surfaces. The protrusion may include a ledge configured to slide along the second axis into a groove of the recess, the groove having upper and lower surfaces to prevent movement of the ledge with respect to the groove along the first axis.
When assembled together, the first and second bodies may correspond to a cone body of a femoral hip assembly as the second implant component. The first body may define a femoral neck and an upper portion of a trunk of the cone body, and the second body may define a lower portion of the trunk of the cone body. The upper and lower portions of the trunk of the cone body may be connectable along a first axis, and the femoral neck of the first body may extend along a second axis that is angled with respect to the first axis. The trunk may defines a maximum outer diameter and a maximum height, and the femoral neck may have a conical proximal surface for connecting with a femoral head, the conical proximal surface defining a center point of the proximal neck, and wherein the first body may define an offset distance measured perpendicularly from the axis to the center point.
A modular femoral trialing kit may include a plurality of the first bodies according to the above, each having a different size or shape, and a plurality of the second bodies according to the above, each having a different size or shape. The maximum outer diameter of the trunk may be provided in sizes of 17, 19, 21, 23, 25, 27, 29, and 31 mm, or in other sizes. The maximum height of the trunk may be provided in sizes of 50, 60, 70, 80, 90, and 100 mm, or in other sizes. The offset distance of the femoral neck may be provided in sizes of 30, 34, 36, 38, 40, and 44 mm, or in other sizes. The kit may further include a locking screw for securing the first body to the second body on a portion of an implant.
A sixth aspect of the present invention is a method of assembling an assembly for attachment to a first implant component, the assembly having a size and shape of a second implant component to be implanted together with the first implant component, including the steps of removably connecting a protrusion of a first body of the assembly into a recess defined by a second body of the assembly, such that the first and second bodies are prevented from separating, and positioning the assembly on the first implant component.
In accordance with other embodiments of the sixth aspect, the method may further include the step of fixedly connecting the first body to the second body together by securing a locking screw through the first body and the second body and into a portion of the first implant component. The step of removably connecting may include moving the protrusion along a first axis and into the recess, and wherein the step of fixedly connecting may include inserting the locking screw through lumens of the first and second bodies that are aligned with a second axis that is substantially perpendicular to the first axis. The step of removably connecting may include moving a spring arm of the protrusion into contact with an internal wall of the recess so that the spring arm presses against the internal wall. The step of removably connecting may include moving two spring arms of the protrusion into contact with opposing internal walls, respectively, of the recess so that the spring arms presses against the respective internal walls.
The method may further include the steps of assessing the biomechanics of a joint with the implanted assembly. The method may further include the step of selecting a permanent implant component having the same dimensions as the assembly. The method may further include the steps of selecting the first body from a kit including a plurality of the first bodies each having a different size or shape, and selecting the second body from the kit including a plurality of the second bodies each having a different size or shape.
A seventh aspect of the present invention is an assembly for attachment to a first implant component, the assembly having a size and shape of a second implant component to be implanted together with the first implant component, including a first body including a plug having a projection, and a second body including a recess having an internal surface, the internal surface defining at least one indentation, wherein in a temporary configuration, when the plug is disposed within the recess and the projection is disposed at least partially within one of the at least one indentations, the first and second bodies are removably connected such that the first and second bodies are prevented from separating.
In accordance with other embodiments of the seventh aspect, the first and second bodies may be connectable along an axis and the at least one indentation may include two or more indentations, and wherein the first and second bodies may permit translational relative movement therebetween along the axis to locate the projection at least partially within different indentations of the two or more indentations without disconnecting the first body from the second body. In a fixed configuration, the first and second bodies may be prevented from separating while relative movement is not permitted between the first and second bodies. The assembly may further include a locking screw, wherein in the fixed configuration, the locking screw is secured through the first body and the second body and into a portion of the first implant component. The plug of the first body and the recess of the second body may be connectable along the axis and may each define lumens aligned with the axis in which the locking screw can be disposed. The plug may include a lever arm on which the projection is disposed. The locking screw may include a cylindrical head, and wherein, when the first and second bodies are in the fixed configuration, the cylindrical head may prevent the lever arm from moving and maintains the projection within one of the at least one indentations. The locking screw may include a head having a noncircular outer circumference defining a circular portion and a relief, and wherein the head may be placed in a first rotational orientation in which the circular portion is adjacent the lever arm and prevents the lever arm from moving and maintains the projection within one of the at least one indentations, and also in a second rotational orientation in which the relief is adjacent the lever arm and allows the lever arm to move. When the head of the locking screw is in the second rotational orientation, the first body may be moved along the axis with respect to the second body. A kit may include the assembly according to the above, and a tool having a prong, wherein the tool can be used to rotate the locking screw with the prong disposed adjacent to the relief.
Each indentation of the at least one indentation may be an annular groove. An external surface of the second body may include an indentation aligned with each of the at least one indentations. The first body may includes a second projection, and wherein in the temporary configuration, both of the projections may be disposed at least partially within one of the at least one annular grooves. The two or more indentations may be evenly spaced along the axis. When assembled together, the first and second bodies may correspond to a cone body of a femoral hip assembly as the second implant component. The first body may define a femoral neck of the cone body, and the second body may define a trunk of the cone body. The first and second bodies may be connectable along a first axis, and the femoral neck of the first body may extend along a second axis that is angled with respect to the first axis. The trunk may defines a maximum outer diameter, and the femoral neck may have a conical proximal surface for connecting with a femoral head, the conical proximal surface defining a center point of the proximal neck, and wherein the first body may define an offset distance measured perpendicularly from the first axis to the center point.
A modular femoral trialing kit may include a plurality of the first bodies according to the above, each having a different size or shape, and a plurality of the second bodies according to the above, each having a different size or shape. The maximum outer diameter of the trunk may be provided in sizes of 17, 19, 21, 23, 25, 27, 29, and 31 mm, or in other sizes. The offset distance of the femoral neck may be provided in sizes of 30, 34, 36, 38, 40, and 44 mm, or in other sizes. The kit may further include a locking screw for securing the first body to the second body on a portion of an implant.
A eighth aspect of the present invention is a method of assembling an assembly for attachment to a first implant component, the assembly having a size and shape of a second implant component to be implanted together with the first implant component, including the steps of removably connecting a plug of a first body of the assembly into a recess of a second body of the assembly by locating a projection of the plug within an indentation defined in an internal surface of the recess, such that the first and second bodies are prevented from separating, and positioning the assembly on the first implant component.
In accordance with other embodiments of the eighth aspect, the method may further include the step of locating the projection of the plug in another indentation defined in the internal surface of the recess without disconnecting the first body from the second body. The method may further include the step of fixedly connecting the first body to the second body together by securing the assembly to the first implant component to prevent relative movement between the first and second bodies. The step of fixedly connecting may include securing a locking screw through the first body and the second body and into a portion of the first implant component. The locking screw may include a cylindrical head and the plug may include a lever arm on which the projection is disposed, and wherein the step of fixedly connecting may include positioning the cylindrical head to prevent the lever arm from moving to maintain the projection within one of the at least one indentations. The locking screw may include a head having a noncircular outer circumference defining a circular portion and a relief and the plug includes a lever arm on which the projection is disposed, and wherein the step of fixedly connecting may include positioning the circular portion of the head adjacent the lever arm to prevent the lever arm from moving and to maintain the projection within one of the at least one indentations. The method may further include the step of positioning the relief of the head adjacent the lever arm to allow the lever arm to move. The method may further include the step of moving the first body along an axis along which the first and second bodies are connected with respect to the second body when the relief of the head adjacent the lever arm to adjust a height of the first body above a bottom of the second body. The step of positioning the relief of the head adjacent the lever arm may include engaging a prong of a tool adjacent to the relief and rotating the tool to rotate the locking screw. The method may further include the step of assessing the biomechanics of a joint with the implanted assembly.
The step of removably connecting may include permitting relative movement translationally along an axis along which the first and second bodies are connectable. The method may further include the step of selecting a permanent implant component having the same dimensions as the assembly. The method may further include the steps of selecting the first body from a kit including a plurality of the first bodies each having a different size or shape, and selecting the second body from the kit including a plurality of the second bodies each having a different size or shape.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a front perspective view of a monolithic trial implant of the prior art.
FIG. 2 is a front perspective view of a trial assembly in accordance with one embodiment of the present disclosure.
FIG. 3 is a front perspective view of a first body and two second bodies of the trial assembly in accordance with the first embodiment.
FIG. 4 is a front sectional view of the trial assembly shown in FIG. 2.
FIG. 5 is an enlarged front sectional view of a portion of the trial assembly shown in FIG. 4.
FIG. 6 is a front perspective view of two first bodies of a trial assembly in accordance with a second embodiment of the present disclosure.
FIG. 7 is a front perspective view of the trial assembly in accordance with the second embodiment.
FIG. 8 is a front perspective view of a first body and two second bodies of the trial assembly in accordance with the second embodiment.
FIG. 9 is a front sectional view of the trial assembly shown in FIG. 7.
FIG. 10 is an enlarged front sectional view of a portion of the trial assembly shown in FIG. 9.
FIG. 11 is a front plan view of a first body of a trial assembly in accordance with a third embodiment of the present disclosure.
FIG. 12 is a front perspective view of the first body of the trial assembly in accordance with the second embodiment.
FIGS. 13-15 are front perspective views of second bodies of the trial assembly in accordance with the second embodiment.
FIGS. 16-18 are front perspective views of trial assemblies including the respective second bodies of FIGS. 13-15 in accordance with the second embodiment.
FIG. 19 is a front sectional view of the trial assembly shown in FIG. 18.
FIG. 20 is a front perspective view of a first body of a trial assembly in accordance with a fourth embodiment of the present disclosure.
FIG. 21 is top perspective view of the first body shown in FIG. 20.
FIG. 22 is a front perspective view of a second body of the trial assembly in accordance with the fourth embodiment.
FIG. 23 is a front perspective view of the trial assembly in accordance with the fourth embodiment.
FIG. 24 is a front perspective view of the trial assembly in accordance with the fourth embodiment together with a locking screw.
FIG. 25 is a front perspective view of a first body of a trial assembly in accordance with a fifth embodiment of the present disclosure.
FIG. 26 is a front perspective view of a second body of the trial assembly in accordance with the fifth embodiment.
FIG. 27 is a front perspective view of a locking screw of the trial assembly in accordance with the fifth embodiment.
FIGS. 28 and 29 are top views of the trial assembly in accordance with the fifth embodiment in unlocked and locked configurations, respectively.
FIG. 30 is a front perspective view of a tool used with the trial assembly in accordance with the fifth embodiment.
FIG. 31 is a chart showing a matrix of size, length, and offset for various cone bodies in accordance with the third embodiment.
DETAILED DESCRIPTION
As shown in FIGS. 2-5, a first embodiment in accordance with the present invention is an assembly 100 used for trialing in the proximal femur. Assembly 100 includes a first body 110 and a second body 140 that are connectable in a temporary configuration and also in a fixed configuration, and a locking screw 70. Bodies 110, 140 are connectable along a vertical axis 102 shown in FIG. 4. When assembled, first and second bodies 110, 140 correspond to and have a size and shape of a cone body of a femoral hip assembly that can be attached to an implant component, such as a distal femoral stem 60.
First body 110 includes a recess 112 extending up from its bottom end to define a cavity. Recess 112 includes a terminal end 114 at the bottom end of first body 110 and an internal surface 116. Internal surface 116 defines a first non-threaded portion 118 and a second threaded portion 120, the latter of which is near the bottom end of first body 110 such that it is located closer to terminal end 114 of recess 112. Non-threaded portion 118 is disposed further into recess 112 and away from terminal end 114. At a portion adjacent terminal end 114, recess 112 has a non-circular, e.g. square, cross section that cooperates with a similar feature of second body 140 to function as an anti-rotation portion 122. That is, a portion of internal surface 116 extending upward from the bottom end of first body 110 is defined by the non-circular cross section. In other embodiments, the non-circular cross section can take on other shapes, such as triangular, oval, hexagonal, etc.
Opposite terminal end 114 of recess 112, a central portion of recess 112 continues upward to define a lumen 124 extending completely through to a top surface of first body 110. The upper end of lumen 124 defines a wider cavity, such that locking screw 70 can be disposed through lumen 124 with the head of locking screw 70 disposed in the wider cavity at its upper end.
The cone body with which assembly 100 corresponds generally includes a femoral neck and a trunk, with first body 110 corresponding to the femoral neck 126 and an upper portion of the trunk 128, and second body 140 comprising a lower portion of the trunk 128. Femoral neck 126 of first body 110 extends along an axis 104 that forms an angle β with respect to axis 102, as shown in FIG. 4.
Second body 140 includes a protrusion 142 that is insertable into recess 112 of first body 110. Protrusion 142 has an external surface 144 that defines a first non-threaded portion 146 and a second threaded portion 148, which is disposed adjacent a terminal end 150 of protrusion 142 and closer to terminal end 150 than non-threaded portion 146. Opposite terminal end 150 is a base end that has a non-circular, e.g. square, cross section to operate as an anti-rotation portion 152 when mated with anti-rotation portion 122 of first body 110. A lumen 154 extends through second body 140 along axis 102 and opens into a wider cavity at its lower end to accept a distal stem 60.
First and second bodies 110, 140 can be assembled in a temporarily connected configuration in which first and second bodies 110, 140 are prevented from separating, although relative movement is permitted between bodies 110, 140. This is facilitated by the threaded and non-threaded portions 118, 120, 146, 148 of bodies 110, 140 and their orientation and cooperation when bodies 110, 140 are assembled. During assembly, threaded portions 120, 148 of recess 110 and protrusion 140, respectively, engage one another as protrusion 140 is screwed into recess 110. Then, threaded portions 120, 148 disengage from one another such the entire threaded portion 148 of protrusion 140 is located within recess 112 past threaded portion 120.
The heights of the threaded and non-threaded portions 118, 120, 146, 148 along axis 102, as well as the heights of anti-rotation portions 122, 152, allow for first body 110 to move translationally along axis 102 and rotationally about axis 102 with respect to second body 140. That is, protrusion 142 can move up and down translationally along axis between a position where its terminal end 150 contacts the upper end of recess 112 and a position where threaded portions 120 and 148 contact one another. Because there is no threaded connection in this position, protrusion 142 can also move rotationally about axis 102 with respect to recess 112. In this temporarily connected configuration, first and second bodies 110, 140 cannot separate on their own due to the juxtaposition of threaded portions 120, 148. Only when threaded portions 120, 148 are reengaged and threaded past one another can first and second bodies 110, 140 be separated.
From the temporarily connected configuration, assembly can be placed into its fixedly connected configuration upon the insertion of locking screw 70 through lumen 124 of first body 110, lumen 154 of lower body 140, and into a distal stem 60 where it is secured by being threaded into the stem 60. This secures first and second bodies 110, 140 together and against the distal stem 60 from any further relative movement between one another. Locking screw 70 prevents relative translational movement of bodies 110, 140 along axis 102 whereas anti-rotation portions 122, 152 prevent relative rotational movement of bodies 110, 140 about axis 102.
A modular kit for a trialing procedure includes a plurality of first bodies 110 each having a different size or shape and a plurality of second bodies 140 each having a different size or shape. Each one of first bodies 110 is connectable with one or more of second bodies 140 to form different, uniquely configured assembly 100. The variation of first and second bodies 110, 140 allows the assemblies 110 to have different maximum diameters of the trunk 128, different maximum heights of the trunk 128, and different offset distances of the femoral neck 126. Incremental sizes of maximum diameters of the trunk 128 can be 17, 19, 21, 23, 25, 27, 29, and 31 mm, among other sizes. Any other sizes within or outside this range can be used. In some embodiments of the kit, a first body 110 having a specifically sized maximum diameter of the trunk 128 can only be connected with a second body 140 having an identically sized maximum diameter of its trunk 128, though other parameters of the bodies 110, 140 may be different. Incremental sizes of maximum heights of the trunk 128 can be 50, 60, 70, 80, 90, and 100 mm, among other sizes. Any other sizes within or outside this range can be used. Incremental sizes of offset distances of the femoral neck 126 of first body 110 can be 30, 34, 36, 38, 40, and 44 mm, among other sizes. Any other sizes within or outside this range can be used. Thus, the modularity of assembly 100 allows surgeons to build assemblies having a particular diameter, height, and offset for a given application while requiring fewer components to resemble all versions of the permanent implant. That is, the modularity of the system requires fewer components than a traditional trialing system in which one trial is required for each permanent implant. In some embodiments of the kit, a pair of bodies 110, 140 sharing a maximum diameter can be offered in multiple heights, and each of these combinations can be offered in multiple offset distances.
While assembly 100 is configured for use in the proximal femur, other two-piece trial implants are contemplated for use in other joints, such as the hip, knee, shoulder, and elbow, among others. The connectable two-piece trial can be used in any scenario in which multiple aspects of the implant can be varied in size and/or shape so that a combined two-piece trial would allow for a reduction in the number of components needed in the operating room for a trialing procedure. In addition, it is also contemplated that the two-piece construct can be utilized as a final implant in any of these anatomical locations when it can be properly secured and stabilized for long-term fixation.
A method of assembling assembly 100 for attachment to a first implant component, such as a distal femoral stem 60, includes a user first selecting an initial size of first and second bodies 110, 140 based on the results of bone preparation. The user then removably connects first body 110 to second body 140 in the temporarily connected configuration, such that first and second bodies 110, 140 are prevented from separating while permitting relative movement therebetween. This is facilitated by inserting protrusion 142 into recess 112, which involves threading threaded portion 148 of protrusion 142 into engagement with threaded portion 120 of recess 112 until the entire threaded portion 148 of protrusion 142 is located within recess 112 past the threaded portion 120 of recess 112.
The method can be performed in the operating room, where a user selects the first and second bodies 110, 140 each from a kit including a plurality of first bodies 110 of different sizes and/or shapes and a plurality of second bodies 140 of different sizes and/or shapes. With the benefit of a kit of various assembly components, this permits the user to build an assembly 100 that meets the size and shape specifications for a particular surgery. Since assembly 100 is used for a trialing procedure, the components can be mated and put in place for trialing by the user with the foresight that it may indeed be necessary to disassemble the trial and substitute another one or both of first and second bodies 110, 140 to provide a trial assembly 100 that results in an acceptable fit for the patient.
When trialing with an assembly as provided herein, the combination of elements can require additional concentration by the user to maintain the configuration and alignment of the parts, i.e. bodies 110, 140, while the assembly is moved toward and assembled to an implant component or bone on the patient. Assembly 100 allows this task to be done with much greater reliability and less risk of disassembly given that bodies 110, 140 can be mated in the temporarily connected configuration. This can be done by the user at the time of selecting each body 110, 140, and then assembly 100 can be easily moved to the implantation site with assurance on behalf of the user that the assembly 100 will stay assembled during this process. The variability allowed in the translational and rotational movement of the bodies 110, 140 with respect to one another allows the user with the freedom to manipulate the final positioning and orientation of assembly 100 easily.
Once assembly 100 is assembled and moved to the implantation site, assembly 100 is then positioned on distal femoral stem 60. Next, first body 110 is fixedly connected to second body 140 in the fixedly connected configuration by securing assembly 100 to stem 60 to prevent relative movement between first and second bodies 110, 140. This is done by securing locking screw 70 through lumen 124 in first body 110 and through lumen 154 of second body 140 and into a portion of stem 60. The distal end of locking screw 70 is threaded into stem 60, while a head of the screw is recessed to be substantially flush with the top of first body 110. Anti-rotation portions 122 and 152 mate to prevent relative rotation between bodies 110, 140 in this assembled configuration.
With assembly fixedly connected to distal stem 60, the user can then perform a trialing procedure by installing a trial femoral head on femoral neck 126, reducing the femoral joint, and assessing the biomechanics of the joint with the implanted assembly 100. If the user determines that the fit of assembly 100 is not appropriate, assembly can be removed by unscrewing locking screw 70 and disassembling locking screw and assembly 100 from stem 60. Then one or both of first and second bodies 110, 140 can be replaced and a new, uniquely configured assembly 100 can be assembled and trialed per the method above. Once the proper fit is achieved, the user can select and install a permanent implant that corresponds to the dimensions of the properly fitted assembly 100.
The benefits of the construction and use of assembly 100 and its modularity are a reduced SKU count, a reduced tray size for trialing, and a trial implant that it is easy to assemble and disassemble and is cheaper to manufacture than conventional one-to-one trial systems.
FIGS. 6-10 depict a second embodiment in accordance with the present invention, which is an assembly 200 also used for trialing in the proximal femur and connected via a different mechanism. Several aspects of assembly 200 are similar to those of assembly 100, and like numerals are used to reference like components.
Assembly 200 includes locking screw 70 along with a first body 210 and a second body 240 that are connectable in a temporary configuration and in a fixed configuration in a similar manner to assembly 100. First body 210 has a recess 212 extending up from its bottom end to define a cavity. Recess 212 includes an internal surface 216 that defines an annular groove 217 therein. Recess 212 extends upward into a lumen 224 to facilitate passage of locking screw 70. Second body 240 includes a protrusion 242 insertable into recess 212 and having an external surface 244 defining an annular groove 245 therein. A lumen 254 extends through second body 240 along axis 202 and accepts distal stem 60 at a cavity in its lower end. A split ring 230 is initially disposed in one of annular grooves 217 and 245. Split ring 230 is a C-shaped clip that allows for slight expansion and compression of its diameter so that it can be fitted within recess 212 and positioned over protrions 242.
First and second bodies 210, 240 can be assembled by inserting protrusion 242 into recess 212 until annular grooves 217 and 245 are aligned so that split ring 230 is disposed at least partially within both annular grooves 217, 245. This places first and second bodies 210, 240 in their temporarily connected configuration in which they are removably connected and prevented from separating. That is, when protrusion 242 is fit into recess 212 to the point where split ring 230 snaps into annular grooves 217 and 245, first and second bodies 210, 240 are retained together unless a force is provided that overcomes a force needed to flex split ring 230 out of one or both grooves 217, 245. This force is calibrated to be high enough to prevent accidental disengagement of first and second bodies 210, 240, while also allowing first and second bodies 210, 240 to be pulled part by a user using one or two hands.
At the base of protrusion 242 outside its external surface 244 are a series of tabs 247 spaced radially about the circumference of protrusion 242. Tabs 247 are configured to mate within indents 219 at a terminal end 214 of recess 212. This provides non-circular sections of each of protrusion 242 and recess 212 that can be mated to prevent relative rotation between first and second bodies 210, 240 when they are assembled in the temporarily connected configuration. In other embodiments, the tabs 247 and indents 219 can be switched so that they are located on the opposite ones of the protrusion 242 and recess 212.
Because of the way split ring 230 fits into grooves 217, 245 in one position along axis 202, and because this position coincides with tabs 247 being disposed within indents 219, the temporarily connected configuration of assembly 200 does not necessarily permit for first body 210 to move translationally along axis 202 and rotationally about axis 202 with respect to second body 240. Before split ring 230 is fully seated in both grooves 217, 245, relative rotation is permitted and relative translation is also permitted up to the point at which protrusion 242 is fully seated within recess 212. In other embodiments, groove 217 and/or groove 245 can be lengthened into recessed annular areas along axis 202 so that some translational movement is permitted once split ring 230 is seated within both grooves.
After assembly is placed in its temporarily connected configuration, assembly 200 can be placed into its fixedly connected configuration upon the insertion of locking screw 70 through lumen 224 of first body 210, lumen 254 of lower body 240, and into a distal stem 60 to secure first and second bodies 210, 240 from further relative movement.
Of course assembly 200 is provided in the same type of modular kit to provide the same benefits as assembly 100. Assembly 200 can also be provided for use in different bones and joints besides just the femur.
A method of assembling assembly 200 follows the same steps as that for assembly 100, though the assembly of sliding protrusion 242 into recess 212 includes moving split ring 230 at least partially into annular groove 245 of protrusion 242 and at least partially into annular groove 217 of recess 212. This includes aligning tabs 247 to be inserted into indents 219. As recess 212 slides over protrusion 242, split ring 230 retracts due to the internal diameter of recess 212. Once split ring 230 engages with the large internal diameter of annular groove 217 of recess 217, split ring 230 expands, thereby retaining the two pieces together. Other aspects of the assembly method are the same as those described above. The temporarily connected configuration similarly allows the user the ability to mate the bodies 210, 240 of the assembly 200 with assurance that they can be manipulated in a trialing procedure without disassembling.
A third embodiment in accordance with the present invention is shown in FIGS. 11-19. An assembly 300 used for trialing in the proximal femur uses a different means of connection. Several aspects of assembly 300 are similar to those of assemblies 100 and 200, and like numerals are used to reference like components. Assembly 300 includes locking screw 70 with a first body 310 and a second body 340 that are connectable in a temporary configuration and also in a fixed configuration.
As shown in FIGS. 11-13, first body 310 defines a protrusion 311 extending downward from its bottom end that is insertable into a recess 341 located at an upper end of second body 340. From the bottom end of first body 310 extending downward, protrusion 311 includes a neck or groove 315 and a horizontally extending rib or ledge 313 that is wider than neck 315 so that neck 315 creates a somewhat annular, horizontal channel located between rib 313 and the bottom end of first body 310. Rib 313 can slide along a horizontal axis 303 into neck 315 during assembly.
Beneath rib 313, a stop 321 extends downward and two spring arms 323 are anchored to stop 321 so that arms 323 each extend in a horizontal direction that is generally planar to rib 313. Spring arms 323 are contoured to each have a C-shape around a lumen 324 that extends completely through protrusion 311 to a top surface of first body 310. The upper end of lumen 324 defines a wider cavity for the head of locking screw 70. In other embodiments, projection 311 can have only spring arm or can have more than two spring arms.
As shown in FIG. 13, recess 341 extends down from the top end of second body 340 to define a cavity. Recess 341 includes a narrow channel 343 at its terminal end and a wider channel 349 above narrow channel 343. Narrow channel 343 houses stop 321 and spring arms 323 of protrusion 311 when first and second bodies 310, 340 are assembled together. More specifically, narrow channel 343 has two concave surfaces 351 that mate with the convex C-shaped contours of spring arms 323. When first body 310 is assembled to second body 340, protrusion 311 is slid horizontally into recess 341 until spring arms 323 snap into place to press against the internal wall of narrow channel 343 at concave surfaces 351. This snap fit allows second body 340 to be seated within first body 310 and prevents first and second bodies 310 and 340 from separating absent an opposing force applied to purposely separate the bodies.
When first and second bodies 310, 340 are assembled, as depicted in FIG. 16, wider channel 349 accommodates horizontal rib 313 and two ledges 325 extend above rib 313 to seat within neck 315 of first body 310. This further guides the fit between bodies 310, 340 and enhances their connection once assembled by preventing movement of rib 313 with respect to neck 315 along a vertical axis 302. Thus, once protrusion 311 is seated within recess 341, first and second bodies 310, 340 are removably connected such that they are prevented from separating.
FIG. 14 depicts a taller second body 340′ that is otherwise similar in structure to second body 340. FIG. 15 depicts a second body 340″ that is also taller than second body 340, but that includes a hood 353 extending upward from its upper surface that acts as a sort of back stop during assembly of first body 310. Second body 340′ is shown attached to first body 310 in FIG. 17. Second body 340″ is shown in FIG. 18 attached to first body 310, which mates with hood 353.
The cone body with which assembly 300 corresponds generally includes a femoral neck and a trunk, with first body 310 corresponding to a femoral neck 326 and an upper portion of the trunk 328, and second body 340 comprising a lower portion of the trunk 328. Femoral neck 326 extends along an axis 304 that forms an angle θ with respect to horizontal axis 303 along which bodies 310, 340 are connectable, as shown in FIG. 19. A lumen 354 extends through second body 340 along vertical axis 302 and opens into a wider cavity at its lower end to accept a distal stem 60.
First and second bodies 310, 340 can be assembled in a temporarily connected configuration in which first and second bodies 310, 340 are prevented from separating, when spring arms 323 of first body 310 press against the internal wall of narrow channel 343 at concave surfaces 351 of second body 340. From the temporarily connected configuration, assembly can be placed into its fixedly connected configuration upon the insertion of locking screw 70 through a lumen 324 of first body 310, lumen 354 of lower body 340, and into a distal stem 60 where it is secured by being threaded into the stem 60. This secures first and second bodies 310, 340 together and against the distal stem 60 from any further relative movement between one another. Assembly of first and second bodies 310, 340 occurs along horizontal axis 303, while locking screw 70 is disposed through lumens 324, 354 that are aligned with vertical axis 302. Axis 302 is substantially perpendicular to axis 303.
Of course, as described above, modular kits can be provided for trialing procedures including a plurality of differently sized first and second bodies of any of the embodiments described herein. Also, differently sized bodies of more than one of the embodiments described herein can be assembled into a kit. Assembly 300, as well as any embodiment described herein, can be modified geometrically to be used in other joints, such as the hip, knee, shoulder, and elbow, among others. FIG. 31 is a chart showing a matrix of size, length, and offset for various cone bodies in accordance with the third embodiment of assembly 300.
A method of assembling assembly 300 is similar to the methods described above except for the different connection of assembly 300. The method includes removably connecting protrusion 311 of first body 310 into recess 341 of second body 340 in the temporarily connected configuration, such that first and second bodies 310, 340 are prevented from separating. Assembly 300 allows this to be done with great reliability and low risk of disassembly given that bodies 310, 340 can be mated in the temporarily connected configuration. A locking screw 70 can then be secured through lumen 324 in first body 310 and through lumen 354 of second body 340 and into a portion of stem 60. The distal end of locking screw 70 is threaded into stem 60, while a head of the screw is recessed to be substantially flush with the top of first body 310. With assembly 300 fixedly connected to distal stem 60, the user can then perform a trialing procedure by installing a trial femoral head on femoral neck 326, reducing the femoral joint, and assessing the biomechanics of the joint with the implanted assembly 300. Further iterations of the method can be performed as necessary, as facilitated by the trialing kit.
As shown in FIGS. 20-24, a fourth embodiment in accordance with the present invention is an assembly 400 used for trialing in the proximal femur. Assembly 400 is similar to those above, with like elements numbered similarly. Assembly 400 includes a first body 410 and a second body 440 that are connectable in a temporary configuration and also in a fixed configuration, and a locking screw 70. Bodies 410, 440 are connectable along a vertical axis as shown in FIG. 23.
First body 410 has a plug 427 that has on each opposite side a flexible tab or lever arm 429 with a projection or nub 431 at its free end. A lumen 424 extends completely through plug 427 so that lever arm 429 is free to flex in and out of lumen 424. While two lever arms 429 are provided in cutouts in the annular wall of plug 427, one or three or more lever arms 429 can be provided.
Second body 440 includes a recess 441 that forms an upper portion of a lumen within second body 440. Recess 441 has an internal cylindrical surface that defines three annular indentations or grooves 442. In other embodiments, at least one annular indentation is provided, and preferably two or more are provided and are preferably evenly spaced along a vertical axis of recess 441. To mark annular indentations 442 to the user, external markings or indentations 456 are provided on an external surface of second body 440, as shown in FIGS. 22 and 23.
First and second bodies 410, 440 can be assembled in a temporarily connected configuration in which plug 427 is disposed within recess 441 such that projections 431 are disposed at least partially within one of indentations 442. In this configuration, first and second bodies 410, 440 are removably connected and prevented from separating. The force provided by lever arm 429 on projection 431 is such that first and second bodies 410, 440 can be moved or translated relative to one another so that projections 431 can be located within different indentations 442 without disconnecting first body 410 from second body 440, i.e. without removing plug 427 from recess 441. This allows a user to set a particular height of first body 410 with respect to second body 440 during a trialing procedure, such that assembly 400 can be said to be of variable height.
Assembly 400 can be placed into its fixedly connected configuration by inserting a locking screw 470 lumen 424 of first body 410 and threading it into a distal stem through recess 441 of second body 440. Locking screw 470 has an elongated head such that the large diameter of the head extends along a majority of the length of locking screw 470, with a narrower threaded portion at its distal end. When locking screw 470 is disposed within lumen 424 of plug 427, enlarged diameter of locking screw 470 closely matches the inner diameter of plug 427 and of lever arms 429. Thus, the presence of locking screw 470 prevents lever arms 429 from moving inward toward lumen 424, and therefore maintains projections 431 within the indentation 455 they are mated with. This effectively locks assembly 400 to a particular height, and also secures first and second bodies 410, 440 together and against the distal stem 60 from any further relative movement between one another.
A method of assembling assembly 400 for attachment to a first implant component, such as a distal femoral stem 60, includes a user first inserting plug 427 into recess 441 until projections 431 are disposed within an annular indentation 455 corresponding to a desired height. This holds first and second bodies 410, 440 in such position even without the presence of locking screw 470. If a change in height of assembly 400 is desired, plug 427 can simply be moved to located projections 431 in another indentation 455. This is done without disconnecting first body 410 from second body 440. When the proper height is determined, which can be done while assembly 400 is located on a stem attached to the patient's bone, first body 410 is fixedly connected to second body 440 in the fixedly connected configuration by securing assembly 400 to stem 60 by securing locking screw 470 through lumen 424 in first body 410 and through second body 440 and into a portion of stem 60. This locks first and second bodies 410, 440 together and also locks the adjusted height of assembly 400.
With assembly fixedly connected to distal stem 60, the user can then perform a trialing procedure by installing a trial femoral head on the femoral neck of first body 410, reducing the femoral joint, and assessing the biomechanics of the joint with the implanted assembly 400. If the user determines that the fit of assembly 400 is not appropriate, locking screw 470 can be removed so that the height of assembly 400 can again be adjusted as described above, or one or both of first and second bodies 410, 440 can be replaced and a new, uniquely configured assembly 400 can be assembled and trialed per the method above. Once the proper fit is achieved, the user can select and install a permanent implant that corresponds to the dimensions of the properly fitted assembly 400.
A fifth embodiment in accordance with the present invention is an assembly 400 that is very similar to assembly 400, with like elements numbered similarly. Assembly 500 is shown in FIGS. 25-30 and is also used for trialing in the proximal femur. A detailed discussion of assembly 500 is omitted in favor of a description of those features and methods that differ from assembly 400.
Assembly 500 can be placed into its fixedly connected configuration by inserting a locking screw 570 into lumen 524 of first body 510 and threading it into a distal stem through recess 541 of second body 540. Locking screw 570 also includes an elongated head 571 that extends along a majority of the length of locking screw 570. Head 571 has a non-circular outer circumference that includes opposing circular or cylindrical portions 572 and opposing flat or planar portions 573. Planar portions 573 form reliefs within a cylindrical envelope defined a cylinder including the surfaces of cylindrical portions 572. Locking screw 570 has a narrower threaded portion at its distal end.
When locking screw 570 is disposed within lumen 524 of plug 527, head 571 can be rotated or placed in a first rotational orientation shown in FIG. 29 in which circular portion 572 is adjacent lever arm 529 and prevents lever arm 529 from moving. This maintains projections 531 within the selected indentation 555. Circular portions 572 are similar to the enlarged diameter of locking screw 470 in this way, in that they closely match the inner diameter of plug 527 and of lever arms 529.
Head 571 can also be rotated or placed in a second rotational orientation shown in FIG. 28 in which the reliefs at planar portions 573 are adjacent lever arms 529, which allows lever arms 529 and projections 531 to move so that the height of assembly 570 can be adjusted without the need to remove locking screw 570. This allows a user to make adjustments to the modular assembly 500 even after its components are assembled by moving first body 510 along second body 540. Once a desired height is achieved, locking screw 570 can be set to its first rotational orientation to effectively lock assembly 500 to secure first and second bodies 510, 540 together and against the distal stem 60 from any further relative movement between one another.
A tool 590 is shown in FIG. 30 that can be used to rotate locking screw 570. Ordinarily, a hex driver can be used in a hex-shaped recess in the head of each of the locking screws herein, including locking screw 570. However, when it is desired to control locking screw 570 from a greater height, perhaps due to limitations provided by the anatomy during a surgery, tool 590 includes prongs 591 that fit within reliefs adjacent planar portions 573 of head 571. This allows tool 590 to rotate locking screw 570 when tool 590 is controlled from its proximal end. A kit can be provided for a user that includes assembly 500 along with tool 590.
Although the invention herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present invention. It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present invention as defined by the appended claims.
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16282866
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howmedica osteonics corp.
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USA
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B2
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Utility Patent Grant (with pre-grant publication) issued on or after January 2, 2001.
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Open
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Apr 27th, 2022 09:01AM
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Apr 27th, 2022 09:01AM
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Stryker
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Health Care
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Health Care Equipment & Services
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nyse:syk
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Stryker
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Apr 19th, 2022 12:00AM
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Jun 2nd, 2020 12:00AM
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https://www.uspto.gov?id=US11304736-20220419
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Rib plate and rib plate system
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A monolithic rib plate is described. The rib plate comprises multiple first screw orifices located substantially along a first line and connected by first bridges, multiple second screw orifices located laterally on one side of the first line and connected by second bridges, wherein one or more of the second bridges have a smaller cross-section than the first bridges, and third bridges, each connecting one of the second screw orifices with one of the first screw orifices. Also described is a rib plate system comprising the monolithic rib plate and at least one of one or more polyaxial locking screws, a tool for removing the second bridges, a tool for bending the monolithic rib plate, and one or more orifice bridge plates.
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11304736
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1. A monolithic rib plate, comprising:
multiple first screw orifices located substantially along a first line and connected by first bridges;
multiple second screw orifices located laterally on one side of the first line and connected by second bridges, wherein one or more of the second bridges have a smaller cross-section than the first bridges; and
third bridges, each connecting one of the second screw orifices with one of the first screw orifices,
wherein at least one of the second screw orifices is located halfway between its closest two first screw orifices.
2. The monolithic rib plate according to claim 1, wherein the second screw orifices each have a curved cross-section.
3. The monolithic rib plate according to claim 1, wherein the one or more second bridges having the smaller cross-section are more flexible than the first bridges.
4. The monolithic rib plate according to claim 1, wherein one or more of the third bridges are more flexible than the first bridges.
5. The monolithic rib plate according to claim 1, wherein each second screw orifice has a center point and wherein a second line extends through the center points of two neighboring second screw orifices, and wherein the one or more of the second bridges having the smaller cross-section and connecting the two neighboring second screw orifices are offset relative to the second line in a direction away from the first line.
6. The monolithic rib plate according to claim 1, wherein at least the one or more of the second bridges having the smaller cross-section are concavely shaped on their side facing the first line.
7. The monolithic rib plate according to claim 1, wherein at least one of the third bridges is concavely shaped on its side facing away from the first line.
8. The monolithic rib plate according to claim 1, wherein one or more of the first and second screw orifices comprises an engagement portion configured to engage a threaded head of a polyaxial locking screw at a selected angular orientation.
9. The monolithic rib plate according to claim 1, wherein the first screw orifices and the second screw orifices define respective central screw axes which are angled to each other.
10. A monolithic rib plate, comprising:
multiple first screw orifices located substantially along a first line and connected by first bridges;
multiple second screw orifices located laterally on one side of the first line and connected by second bridges, wherein one or more of the second bridges have a smaller cross-section than the first bridges; and
third bridges, each connecting one of the second screw orifices with one of the first screw orifices,
wherein at least one of the second screw orifices is connected to one of the first screw orifices by one of the third bridges and to another of the first screw orifices by another of the third bridges.
11. The monolithic rib plate according to claim 10, wherein a combined cross-section of the two third bridges connecting the second screw orifice to the two first screw orifices is smaller than the cross-section of the first bridge connecting these two first screw orifices.
12. A monolithic rib plate, comprising:
multiple first screw orifices located substantially along a first line and connected by first bridges;
multiple second screw orifices located laterally on one side of the first line and connected by second bridges, wherein one or more of the second bridges have a smaller cross-section than the first bridges; and
third bridges, each connecting one of the second screw orifices with one of the first screw orifices,
wherein a greatest distance between two of the third bridges connecting one of the first screw orifices with its closest two second screw orifices is equal to or less than a shortest distance between the one first screw orifice and the second bridge connecting the closest two second screw orifices.
13. A monolithic rib plate, comprising:
multiple first screw orifices located substantially along a first line and connected by first bridges;
multiple second screw orifices located laterally on one side of the first line and connected by second bridges, wherein one or more of the second bridges have a smaller cross-section than the first bridges; and
third bridges, each connecting one of the second screw orifices with one of the first screw orifices,
wherein a free space at least partially enclosed by one second bridge and two third bridges extends a distance in a direction of the first line equal to or less than a distance in a direction orthogonal to the first line.
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13
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CROSS-REFERENCE TO RELATED APPLICATIONS
This application claims the benefit of the filing date of European Patent Application No. 19177888.5 filed Jun. 3, 2019, the disclosure of which is hereby incorporated herein by reference.
TECHNICAL FIELD
The present disclosure provides a rib plate and a rib plate system for fixing parts of a fractured rib at a desired distance and orientation relative to each other.
BACKGROUND OF THE INVENTION
US 2017/0065317 A1 describes various bone plates. These bone plates comprise screw orifices connected by bridges. Further prior art can be found in DE 10 2006 042 277 A1, US 2010/331844 A1, US 2013/079777 A1, US 2018/344372 A1 and US 2018/368896 A1.
An underlying object is to provide a rib plate and rib plate system that improve versatility, reliability and handling of a surgical procedure in which the rib plate is attached to parts of a fractured rib for fixing them at a desired distance and orientation relative to each other.
BRIEF SUMMARY OF THE INVENTION
According to a first aspect of the present disclosure, a monolithic rib plate comprises multiple first screw orifices located substantially along a first line and connected by first bridges, multiple second screw orifices located laterally on one side of the first line and connected by second bridges, wherein one or more of the second bridges have a smaller cross-section than the first bridges, and third bridges, each connecting one of the second screw orifices with one of the first screw orifices.
The first line may be a straight line or a curved line. A screw orifice is defined as a structure, such as a circular structure, with a hole, such as a circular hole, therethrough.
The first screw orifices, being located substantially along the first line, may be located with their respective center points either on the first line or offset to the first line. Such offset first screw orifices may be alternatingly arranged on the two sides of the first line along the first line. For example, the first screw orifices may be alternatingly arranged at distances, for example at equal distance, from the first line at opposite sides of the first line.
The first bridges may each extend from one first screw orifice to its closest neighboring first screw orifice. So, two closest neighboring first screw orifices may be directly connected by one or more of the first bridges, such as one first bridge. For example, one end of the first bridge connecting two closest neighboring first screw orifices may extend from the one first screw orifice and the opposite end of that first bridge may extend from the other closest neighboring first screw orifice, for example from sides of the respective first screw orifices facing each other.
The second screw orifices, being located laterally on one side of the first line, may be located with their respective center points on one side of the first line, for example each at equal distances from the first line. The second screw orifices and/or the center points of the second screw orifices may be further away from the first line than the first screw orifices and/or the center points of the first screw orifices.
The second bridges may each extend from one second screw orifice to its closest neighboring second screw orifice. So, two closest neighboring second screw orifices may be directly connected by one or more second bridges, such as one second bridge. For example, one end of the second bridge connecting two neighboring second screw orifices may extend from the one second screw orifice and the opposite end of that second bridge may extend from the other closest neighboring second screw orifice, for example from sides of the respective second screw orifices facing each other. The one or more of the second bridges having a smaller cross-section than the first bridges may each have a cross-section which is smaller than the smallest cross-section of the first bridges. As understood herein, the cross-section may be defined by a cross-sectional area.
The third bridges may each extend from one of the second screw orifices to one of its closest neighboring first screw orifices. So, one of the second screw orifices may be directly connected to its closest neighboring first screw orifice by one or more of the third bridges, such as one third bridge. For example, one end of the third bridge connecting two closest neighboring second and first screw orifices extends from the one second screw orifice and the other opposite end of that third bridge may extend from the closest neighboring first screw orifice, for example from sides of the respective second and first screw orifices facing each other.
The second screw orifices may have a curved cross-section, in particular in a plane that extends perpendicular to the first line. An inner radius of the curved second screw orifices may be between 1 mm and 6 mm. The angle of total curvature, for example in a plane of the cross-section of the second screw orifices and orthogonal to the first line, may be between 45° and 100°.
The one or more second bridges having the smaller cross-section may be more flexible than the first bridges. For example, the one or more second bridges having the smaller cross-section may be more flexible in a direction along a straight line parallel to the first line than the first bridges. Alternatively or additionally, the one or more second bridges having the smaller cross-section may be more flexible in a direction along a straight line orthogonal to the first line than the first bridges.
One or more of the third bridges may be more flexible than the first bridges. For example, the one or more third bridges may be more flexible in a direction along a straight line orthogonal to the first line than the first bridges. Alternatively or additionally, one or more of the third bridges may be more flexible in a direction along a straight line parallel to the first line than the first bridges. For example, each third bridge may be more flexible in one direction along a straight line parallel to the first line than in the opposite direction along the straight line parallel to the first line.
Each screw orifice, such as each second screw orifice, may have a center point. A second line may extend through the center points of two neighboring second screw orifices, and the one or more of the second bridges having a smaller cross-section and connecting the two neighboring second screw orifices may be offset relative to the second line in a direction away from the first line. For example, the ends of the second bridge connecting the two neighboring second screw orifices are offset from the second line in a direction away from the first line. Such an approach may result in an off-center connection and force distribution between neighboring second screw orifices. The one or more of the second bridges having a smaller cross-section may extend from the first line as far as or less than the second screw orifices.
At least the one or more of the second bridges having a smaller cross-section may be concavely shaped on their side facing the first line. At least one of the second bridges may be convexly shaped on its side facing away from the first line. For example, at least the one or more of the second bridges having a smaller cross-section may be arc-shaped, such as V-shaped. Two leg portions may extend from a common point of origin at an angle of less than 180° away from each other to connect with the respective second screw orifices. Each leg portion may extend along a line having an extension that intersects a screw hole in the closest neighboring second screw orifice to the respective leg. For example, the line may intersect a center point of the closest neighboring second screw orifice.
At least one of the second screw orifices may be connected to one of the first screw orifices by one of the third bridges and to another of the first screw orifices by another of the third bridges. The combined cross-section of the two third bridges connecting the second screw orifice to the two first screw orifices may be smaller than the cross-section of the first bridge connecting these two first screw orifices. For example, each second screw orifice may have a center point and an intersection line may extend through the center point orthogonal to the first line. The two third bridges may extend from the second screw orifice symmetrically to the intersection line.
At least one of the third bridges may be concavely shaped on its side facing away from the first line. At least one of the third bridges may be convexly shaped on its side facing towards the first line. For example, at least one of the third bridges is arc-shaped, such as V-shaped. Two leg portions may extend from a common point of origin at an angle of less than 180° to connect to the respective first and second orifice. Each leg portion may extend along a line having an extension that intersects a screw hole in the closest neighboring second screw orifice and a screw hole in the closest neighboring first screw orifice to the respective leg. For example, the line may intersect a center point of the respective closest neighboring screw orifice. The leg portions may be open at an angle between 100° and 140°, and may have the same length and/or the same cross-section.
At least one of the second screw orifices may be located halfway between its closest neighboring two first screw orifices. The second screw orifices may be entirely distanced beyond the first screw orifices from the first line. In other words, the end of each of the second screw orifices closest to the first line is still farther away from the first line than the end of each of the first screw orifices farthest away from the first line.
A greatest distance between two of the third bridges connecting one of the first screw orifices with its closest two second screw orifices may be equal to or less than a shortest distance between the one first screw orifice and the second bridge connecting the closest two second screw orifices. A free space at least partially enclosed by one second bridge and two third bridges may extend a distance in a direction of the first line equal to or less than a distance in a direction orthogonal to the first line.
One or more of the first and second screw orifices may comprise an engagement portion configured to engage a threaded head of a polyaxial locking screw at a selected angular orientation. The engagement portion may be realized as a circumferential ring-shaped lip in the screw hole of the respective screw orifice.
The rib plate may comprise between 2 and 30 first screw orifices, such as any number from 5 to 20. The second screw orifices may be as many or less than the number of first screw orifices, such as one less than the number of first screw orifices.
The first screw orifices and the second screw orifices may define respective central screw axes which are angled to each other. For example, the angle is between 30° and 120°, such as between 45° and 90°. As understood herein, central screw axis may be defined by a straight line intersecting the center point of the respective screw orifice or its screw hole while extending orthogonally therethrough. The screw orifices may be symmetrical about their respective central screw axis. The central screw axes may extend orthogonally to a surface of the bone plate.
According to a second aspect of the present disclosure, a rib plate system comprises the monolithic rib plate and at least one of one or more polyaxial locking screws, a tool for removing the second bridges, a tool for bending the monolithic rib plate, and one or more second screw orifice bridge plates. For example, the bridge plates described below. When polyaxial locking screws are provided, they may engage the respective engagement portion at a maximum engagement angle of up to 15°, such as up to 10°. This maximum engagement angle may be uniform about the respective central screw axis.
According to a third aspect of the present disclosure, a rib plate system comprises a monolithic rib plate and one or more orifice bridge plates, wherein the monolithic rib plate comprises multiple screw orifices of which two or more first screw orifices are located substantially along a first line and connected by first bridges. The bridge plate comprises multiple plate screw orifices connected by plate bridges, wherein the arrangement of at least two plate screw orifices of the bridge plate matches the arrangement of at least two screw orifices of the rib plate, and wherein one or more of the plate bridges have a smaller cross-section than the first bridges.
The arrangement of at least two plate screw orifices of the bridge plate may match the arrangement of at least two screw orifices of the rib plate. This may be realized by the provision of the at least two plate screw orifices of the bridge plate being equally distanced and oriented to each other as the at least two matching screw orifices of the rib plate. For example, the bridge plate may have a pattern of at least two plate screw orifices which matches a pattern of screw orifices of the rib plate when the bridge plate is placed on the rib plate. The greatest single bridge cross-section between the at least two plate screw orifices may be less than the bridge cross-section of the at least two matching screw orifices of the rib plate. The bridge plate may be positioned such on the rib plate that the center points of the at least two plate screw orifices of the bridge plate are concentric with the center points of the at least two screw orifices of the rib plate. Such a matching arrangement allows a local adjustment of the flexibility of the rib plate as desired, since the flexibility between the at least two screw orifices of the rib plate can be decreased by the rib plate being additionally mounted thereto.
The rib plate may comprise second screw orifices each extending from and connected to the first screw orifices by third bridges, for example the third bridges described herein in the context of the first aspect. The arrangement of the at least two plate screw orifices of the bridge plate may match the arrangement of at least two of the second screw orifices of the rib plate. The second screw orifices may further have the properties of the second screw orifices described herein in the context of the first aspect. The one or more plate bridges having the smaller cross-section may have the properties described herein with regard to the second bridges in the context of the first aspect.
At least one of the plate screw orifices may be connected to a neighboring plate screw orifice by two of the second bridges. A space between the two plate bridges may be shaped as a rhombus. A greatest distance between the two plate bridges connecting neighboring plate screw orifices may be equal to or greater than a shortest distance between the two plate screw orifices. Each first screw orifice may be connected by one of the first bridges to its neighboring first screw orifice. The combined cross-section of the two plate bridges may be smaller than the cross-section of one of the first bridges. The cross-section of a plate bridge may be between 50% and 100% of the cross-section of the one of the first bridges. The plate screw orifices may have screw holes with a larger diameter than the screw holes of the lateral and/or first screw orifices.
According to a fourth aspect of the present invention, a monolithic rib plate comprises a multiple first screw orifices located substantially along a first line and connected by first bridges, multiple second screw orifices located laterally on one side of the first line and connected by second bridges, and third bridges, each connecting one of the second screw orifices with one of the first screw orifices. Each second screw orifice has a center point and wherein a second line extends through the center points of two neighboring second screw orifices, one or more of the second bridges have a smaller cross-section than the first bridges, and the one or more of the second bridges having a smaller cross-section and connecting the two neighboring second screw orifices are offset relative to the second line in a direction away from the first line.
BRIEF DESCRIPTION OF THE DRAWINGS
The foregoing summary and the following detailed description of the present disclosure will be better understood when read in conjunction with the appended drawings. In the drawings:
FIG. 1A is a front view of a first rib plate according to an embodiment of the present disclosure, with screw orifices connected by bridges;
FIG. 1B is a top view of the rib plate in FIG. 1A;
FIG. 1C is a cross-sectional view S-S through the rib plate in FIG. 1A;
FIG. 2 is a front view of the rib plate in FIG. 1A with two bridges being removed;
FIG. 3 is a front view of the rib plate in FIG. 2 being bent;
FIG. 4 is a front view of the rib plate in FIG. 3 fixing two parts of a fractured rib at a desired distance and orientation by means of screws engaging with the screw orifices;
FIG. 5 is a perspective view of a second rib plate having curved hooks extending from first screw orifices;
FIG. 6 is a perspective view of a modification of the second rib plate in FIG. 5 having a second screw orifice portion in-between the hooks;
FIG. 7 is a perspective view of another modification of the second rib plate in FIG. 5 having another second screw orifice portion in between the hooks;
FIG. 8 is a perspective view of a third rib plate having curved screw orifices with or without a bridge in-between; and
FIG. 9 is a perspective view of a rib plate system with a fourth rib plate having curved screw orifices and a screw orifice bridge plate for further reinforcement in-between neighboring screw orifices.
DETAILED DESCRIPTION
In the drawings, the same reference numerals are used to denote the same or similar features.
FIG. 1A shows a first monolithic rib plate 1 from its front. The monolithic rib plate 1 may be an integral one-piece plate, such as one-piece plate made from a single material (e.g., a metallic material). The rib plate 1 comprises seven planar and circular first screw orifices 3, which each have a circular hole 5 and a center point 7 at their center. The first screw orifices 3 are located along a straight first line A at equal distances and connected by uniform first bridges 9.
The rib plate 1 further has six curved and circular second screw orifices 11, which each have a circular hole 13 and a center point 15 at their center. The second screw orifices 11 are located laterally on one side of the first line A along a straight second line B at equal distances and connected by uniform second bridges 17. The second bridges 17 have a smaller cross-section (i.e., cross-sectional area) than the first bridges 9.
Having a smaller cross-section may in some implementations have the general purpose to improve bending and cutting compared to a greater cross-section. Each reference to a cross-section of a bridge may refer to a cross-section of a portion of the respective bridge. The “smaller” comparison may refer to the smallest cross-section of one bridge being smaller than the smallest cross-section of another bridge.
The rib plate 1 further comprises third bridges 19. Each third bridge 19 connects one of the second screw orifices 11 with one of its closest neighboring first screw orifices 3.
In the embodiment of the first rib plate 1 shown in FIG. 1A, the center points 15 of the second screw orifices 11 are located on a second straight line B parallel to the first straight line A. Here, the second screw orifices 11 are located halfway between their respective closest neighboring two first screw orifices 3. These neighboring two first screw orifices 3 have a distance between their respective center points 7 of 10 mm along the first line A. They are also distanced entirely beyond their closest neighboring two first screw orifices 3 from the first line A.
The third bridges 19 are arc-shaped. Concretely, they substantially have the form of a V. Each of the third bridges 19 has a concave side facing away from the first line A and a convex side facing towards the first line A. The V-shape is constituted by two leg portions 19a, 19b extending from a common point of origin 19c at an angle of 120°. One leg portion 19a extends from the respective second screw orifice 11 orthogonally toward the first line A. In the present embodiment, the leg portions 19a, 19b are equally long and have a uniform cross-section. The second screw orifices 11 are connected to one of the first screw orifices 3 by one of the third bridges 19 and to another of the first screw orifices 3 by another of the third bridges 19. The combined cross-section of the two third bridges 19 connecting the second screw orifice 11 to the two first screw orifices 3 is smaller than the cross-section of the first bridge 9 connecting these two first screw orifices 3. Each second screw orifice 11 has an intersection line I extending through its center point 15 orthogonal to the first line A. The two third bridges 19 extend from the second screw orifice 11 symmetrically to the intersection line I.
The screw orifices 3, 11 comprise an engagement portion 21 in the form of a circumferential ring-shaped lip 21 in their respective hole 5, 13. The engagement portion 21 is configured to engage a threaded head of a polyaxial locking screw at a selected angular orientation as described below with reference to FIG. 1C. The lip 21 has a thickness of approximately 0.15 mm. It extends at an angle of 120° towards the center point 7, 15 of the respective screw orifice 3, 11. The thickness of the rib plate 1 is 1 mm, but could generally range between 0.5 mm and 4 mm.
FIG. 1B shows a planar view of the first rib plate 1 to better illustrate the second bridges 17 connecting the second screw orifices 11. As illustrated in FIG. 1B, the second bridges 11 are arc-shaped (substantially in the form of a V). They have a concave side facing towards the first line A and a convex side facing away from the first line A. The V-shape is constituted by two leg portions 17a, 17b extending from a common point of origin 17c at an angle of 120°. Each leg portion 17a, 17b may extend along a uniform line having an extension that intersects the circular hole 13 and/or the center point 15 of the closest neighboring second screw orifice 11 of the respective leg 17a, 17b. In the present embodiment, the legs are equally long and have a uniform cross-section.
FIG. 1C shows a cross-section S-S indicated in FIG. 1A through the rib plate 1 to better illustrate the curved second screw orifices 11. As shown, the second screw orifices 11 are curved in a plane that extends perpendicular to the first line A. An inner uniform radius R of the curved second screw orifices 11 may be between 1 mm and 6 mm (e.g., between 2 mm and 5 mm, such as between 3 mm and 4 mm). An angle of total curvature a of the second screw orifices 11 in the plane of curvature may be between 45° and 110° (e.g., between 90 and 100°). The first screw orifices 3 and the second screw orifices 11 define respective central screw axes 3a, 11a about which the first screw orifices 3 and the second screw orifices 11 are symmetrical, wherein the central screw axes 3a, 11a extend orthogonally to a surface of the bone plate 1, i.e., along an axis normal to a surface of the bone plate 1. The central screw axes 3a, 11a viewed from the side of the rib plate 1—in the direction of the first line A—are inclined to each other at an inclination angle β of between approximately or exactly 30° and 120°, between 45° and 90°, between 45° and 50°, or here 49°.
A polyaxial screw can be engaged with the engagement portion 21 of the respective first screw orifice 3 and/or the respective second screw orifice 11 at a maximum engagement angle γ of up to approximately or exactly 15°, 12°, or 10° from the respective central screw axes 3a, 11a, resulting in a cone shaped engagement zone with its tip in the center of the respective screw orifices 3, 11 and on their respective central screw axes 3a, 11a. The outer surface of this cone shape shaped engagement zone is defined in FIG. 1C by respectively angled screw axes 3b, 11b which are angled relative to the respective central screw axes 3a, 11a at the maximum angle in opposite directions from the respective central screw axes 3a, 11a. Thus, when viewed form the side of the rib plate 1, the angled screw axes 3b, 11b overlap each other at a maximum angle β1 (β+2×γ) and at a minimum angle β2 (β−2×γ). Thereby, a small angle of deviation from the central screw axes 3a, 11a of 10°, for example, leads to a large angular range, here 40°, between the maximum angle β1, here 69°, and the minimum angle β2, here 29°, for adjusting polyaxial screws to the available rib bone material. Thereby, neighboring screws can be angled not only toward each other but also away from each other in different planes and directions, allowing the surgeon to achieve a stronger, more reliable connection between the rib plate 1 and an underlying rib.
FIG. 2 shows the rib plate 1 in which the outermost second bridges 17 have been removed. This can be done either during or prior to surgery to locally adjust the flexibility of the rib plate 1, i.e., increasing the flexibility by removing bridges in general. The removal of a second bridge 17 can be performed by inserting a tool for removing the second bridges between two neighboring second screw orifices 11. Then the second screw bridge 17 therebetween are cut to disconnect its two legs 17a, 17b, remove the second bridge 17 partially or remove the second bridge 17 entirely—the latter of which is shown here.
A greatest distance X between two of the third bridges 19 connecting one of the first screw orifices 3 with its closest two second screw orifices 11 is less than a shortest distance Y between the one first screw orifice 3 and the second bridge 17 connecting the closest two second screw orifices 11. A free space 23 enclosed by one second bridge 17 and two third bridges 3 extends a distance X in a direction of the first line A equal to or less than a distance Y in a direction orthogonal to the first line A. By removing a second bridge 17 the respective neighboring second screw orifices 11 become more flexible.
FIG. 3 shows the rib plate 1 of FIG. 2, which has been bent such that the first screw orifices 3 are now located along a curved first line A. This can be performed by a bending tool prior to or during surgery to adjust the rib plate 1 to parts of a fractured rib. Such bending into an anatomical curvature is simplified not only by a possible prior removal of second bridges 17 but also by the arrangement of the second bridges 17 that remain on the rib plate 1. The ends of the second bridge 17 connecting two neighboring second screw orifices 11 are offset from the second line B, which here uniformly extends through the center points 15 of the two neighboring second screw orifices 11, in a direction away from the first line A. As shown, the second bridges 17 extend from the first line A as far as the second screw orifices 11.
FIG. 4 shows the rib plate 1 of FIG. 3 fixing two parts 25a, 25b of a fractured rib 25 at a desired distance and orientation relative to each other by means of screws 27 engaging with the respective engagement portion 21 of the holes 5, 13 of respective screw orifices 3, 11. For this purpose polyaxial locking screws 27 with a threaded head (not shown) are used. As illustrated in FIG. 4, only some of the screw orifices 3, 11 may be fixed to the respective fractures rib parts 25a, 25b in order to adjust the flexibility of the rib plate 1 on the fractured rib 25.
FIG. 5 shows a perspective view of a second monolithic rib plate 31 which differs from the first rib plate 1 by lacking second screw orifices, second bridges and third bridges. Instead, the second rib plate 31 has curved hooks 33 extending from the first screw orifices 3 along a plane, which is orthogonal to the first line A and intersects the center points 5 of the respective first screw orifices 3. The angle of total curvature of the hooks 33 corresponds to the angle of total curvature of the second screw orifices 11 of the first rib plate 1.
FIG. 6 shows a modification of the second rib plate 31 of FIG. 5. The modification has additionally to the curved hooks 33 extending from the first screw orifices 3 a uniform single hook portion 35 in-between hooks 33 and located in the center of the rib plate 31. The hook portion 35 is wider than the hooks 33 in the direction of the first line A. The hook portion 35 comprises second screw orifices 11, which are symmetrically arranged with regard to a central plane of the hook portion 35 extending orthogonally to the first line A. The second screw orifices 11 are located along a second line B parallel to the first line A. The portions of the hook portion 35 between two second screw orifices 11 may also be referred to as second bridges 37. Multiple third bridge portions 39 connect the hook portion 35 with multiple first screw orifices 3. The third bridges 39 are as flexible as the first bridges 9 but less flexible than the second bridges 37.
FIG. 7 shows another modification of the second rib plate 31 of FIG. 5. The modification differs from the modification in FIG. 6 by a single hook portion 41 which now comprises cutouts 43 and one second screw orifice 11 on each end of the hook portion 41 along the second line B connected by second bridges 45 to the central hook portion 41. The central hook portion 41 is connected to multiple first screw orifices 3 by third bridges 47. The third bridges 47 are as flexible as the first bridges 9 but less flexible than the second bridges 45.
FIG. 8 shows a third monolithic rib plate 51 comprising the curved second screw orifices 11 of the first plate 1 each connected by one of the third bridges 53 to a respective center of a first bridge 9. Thereby, each of the second screw orifices 11 is connected to its closest neighboring first screw orifices 3 via one of the third bridges 53 and one of the first bridges 9. In the center of the rib plate 51 a single second bridge portion 55 connects the two neighboring central second screw orifices 11 with each other. The second bridge portion 55 also connects these two central screw orifices 11 with two of the first bridges 9 of three first screw orifices 3 located in-between along the first line A. The second bridge portion 55 comprises multiple V-shape portions 57 in its extension between the two neighboring central second screw orifices 11.
FIG. 9 shows a rib plate system 61. The rib plate system 61 comprises a fourth monolithic rib plate 71 and an orifice bridge plate 81. Instead of the fourth monolithic rib plate 71, the system 61 may comprise any of the other aforementioned rib plates 1, 31, 51 as well as their respective modifications.
The fourth rib plate 71 comprises multiple screw orifices 3, 11. More than two of the first screw orifices 3 are located substantially along a first line A and connected by first bridges 9, just like in the first rib plate 1 shown in FIG. 1A. The rib plate 71 further comprises second screw orifices 11 along the second line B. The second screw orifices 11 extend from and are connected to the first screw orifices 3 by single third bridges 53, just like in the third rib plate 51 shown in FIG. 8. Alternatively, the second screw orifices 11 may be connected to the first screw orifices 3 by the third bridges 19 described above in the context of the first rib plate 1. The second screw orifices 11 may further have the properties of the second screw orifices described above in the context of the first rib plate 1. For example, they may be connected by the second bridges 17 of the first plate 1. These second bridges 17 may have the properties described above in the context of the first rib plate 1.
The bridge plate 81 comprises multiple plate screw orifices 83 along a plate line C and connected by plate bridges 85. The arrangement of at least two of the plate screw orifices 83 of the bridge plate 81 matches the arrangement of at least two of the screw orifices 3, 11 of the rib plate 71. Center points 87 of respective circular holes 89 of the at least two of the plate screw orifices 83 of the bridge plate 81 are matching the center points 7, 15 of the at least two screw orifices 3, 11 of the rib plate 71. For example, the matching is realized by the center points 87 of the respective circular holes 89 of the at least two of the plate screw orifices 83 of the bridge plate 81 being concentric with the center points 7, 15 of the at least two screw orifices 3, 11 of the rib plate 71, when the bridge plate 81 is placed on the rib plate 71. The greatest single plate bridge 85 cross-section between the at least two plate screw orifices 83 is less than the smallest first bridge cross-section of the at least two matching screw orifices 3, 11 of the rib plate 71. The arrangement of the at least two plate screw orifices 83 of the bridge plate 81 may match the arrangement of at least two second screw orifices 11 of the rib plate 71. The number of plate screw orifices may be from 2 to 10, such as 3 to 7. Here, the number of plate screw orifices is three, which offers a variety of applications at a minimum size of the bridge plate 81. For example, one plate screw orifice 83 can be removed from the other two, if necessary. Also, screws 27 can be placed in only two or all of the three plate screw orifices 83 for an individual adjustment of the flexibility of the rib plate system 61 in a state attached to parts 25a, 25b of a fractured rib 25.
In this case, a plate screw orifice 83 is connected to a neighboring plate screw orifice 83 by two second bridges 85. A space 91 between the two second bridges 85 is shaped as a rhombus. A greatest distance between the two plate bridges 85 connecting neighboring plate screw orifices 83 is greater than a shortest distance between the two plate screw orifices 83. A first screw orifice 3 is connected by one first bridge 9 to its neighboring first screw orifice 3. The combined cross-section of the two plate bridges 85 is smaller than the cross-section of the first bridges 9. The cross-section of a single plate bridge 85 is between 50% and 100% of the cross-section of the first bridges 9. The plate screw orifices 83 may have holes 89 with a larger diameter than the holes 13, 5 of the second and/or first screw orifices 11, 3.
The disclosure also provides a surgical technique of applying a rib plate 1, 31, 51, 71 to parts 25a, 25b of a fractures rib 25. This technique includes the step of cutting or more second bridges 17 and/or third bridges 19 to adjust the flexibility in a portion of the rib plate 1, 31, 51, 71. The technique also includes bending the rib plate 1, 31, 51, 71 in a lateral direction to adjust the rib plate 1, 31, 51, 71 to the curvature of the fractured rib 25, and attaching the rib plate 1, 31, 51, 71 with screws 27 engaging only some or all of the screw orifices 3, 11.
The technique may include the step of bending the rib plate 1, 31, 51, 71 in at least two planes orthogonal to each other to even better adjust the rib plate 1, 31, 51, 71 to parts 25a, 25b of the fractured rib 25. Also provided may be the step of attaching the rib plate 1, 31, 51, 71 with screws 27 engaging the screw orifices 3, 11 symmetrically to a central cross-sectional plane through the rib plate rib plate 1, 31, 51, 71 orthogonal to the first line A. Further, the step of attaching may be limited to attaching the rib plate 1, 31, 51, 71 with screws 27 engaging only those of the second screw orifices 11 still comprising a second bridge 17 connecting them to a neighboring second screw orifice 11. Optionally, the step of attaching may require that all of the screw orifices 3, 11 can serve for the engagement of a screw but the central one or two screw orifices, which remain screw-free after surgery.
It should be understood that the invention is not limited to the specific embodiments disclosed above and only limited by the scope of the claims that follow.
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16890412
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stryker european operations holdings llc
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USA
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B2
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Utility Patent Grant (with pre-grant publication) issued on or after January 2, 2001.
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Open
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Apr 20th, 2022 02:51PM
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Apr 20th, 2022 02:51PM
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Stryker
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Health Care
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Health Care Equipment & Services
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nyse:syk
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Stryker
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Apr 19th, 2022 12:00AM
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Dec 6th, 2019 12:00AM
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https://www.uspto.gov?id=US11304758-20220419
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System and method for surgical planning
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A memory device stores instructions, which, when executed by a controller, cause the controller to perform tasks. The tasks include obtaining a three-dimensional (3D) model of a patient's pelvis, identifying two landmarks of the 3D model of the patient's pelvis, defining a coronal radiographic plane of the patient, and determining a mediolateral axis of the 3D axis based on the two landmarks. The tasks also include planning the surgical placement of the acetabular cup into the acetabulum by positioning a virtual model of the acetabular cup relative to the 3D model and determining a planned version and a planned inclination based on the virtual model of the acetabular cup, the mediolateral axis and the coronal radiographic plane.
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11304758
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1. A system for facilitating surgical placement of an acetabular cup at an acetabulum of a patient's pelvis, the system comprising:
a memory device storing instructions, which, when executed by a controller, cause the controller to perform tasks comprising:
obtaining a model of the patient's pelvis;
identifying two landmarks of the model of the patient's pelvis;
defining a coronal radiographic plane of the patient;
determining a longitudinal axis based on the two landmarks and the coronal radiographic plane; and
planning the surgical placement of the acetabular cup into the acetabulum by:
positioning a model of the acetabular cup relative to the model of the patient's pelvis, and
determining a planned version and a planned inclination based on a relationship between the model of the acetabular cup, the longitudinal axis, and the coronal radiographic plane.
2. The system of claim 1, wherein identifying the two landmarks comprises defining the two landmarks based on a line drawn relative to the model of the patient's pelvis.
3. The system of claim 1, wherein determining the planned version and the planned inclination comprises receiving user input and determining the planned version and the planned inclination based on the user input.
4. The system of claim 1, wherein positioning the model of the acetabular cup comprises receiving user input and positioning the model of the acetabular cup based on the user input.
5. The system of claim 1, wherein defining the coronal radiographic plane of the patient comprises defining the coronal radiographic plane based on the model of the patient's pelvis.
6. The system of claim 1, comprising a robotic device;
wherein the tasks further comprise controlling the robotic device to facilitate implantation of the acetabular cup in accordance with the planned version and the planned inclination.
7. The system of claim 1, wherein the tasks further comprise:
determining a mediolateral axis within the model of the patient's pelvis based on positions of the two landmarks; and
determining the longitudinal axis within the model of the patient's pelvis based on the mediolateral axis and the coronal radiographic plane.
8. The system of claim 7, wherein determining the longitudinal axis comprises determining the longitudinal axis as a line substantially transverse to the mediolateral axis and substantially parallel with the coronal radiographic plane.
9. A method, comprising:
obtaining a three-dimensional (3D) model of a patient's pelvis;
identifying two landmarks of the 3D model of the patient's pelvis;
defining a coronal radiographic plane of the patient;
determining a longitudinal axis based on the two landmarks and the coronal radiographic plane; and
planning surgical placement of an acetabular cup into an acetabulum by:
positioning a virtual model of the acetabular cup relative to the 3D model, and
determining a planned version and a planned inclination based on a relationship between the virtual model of the acetabular cup, the longitudinal axis, and the coronal radiographic plane.
10. The method of claim 9, wherein identifying the two landmarks comprises defining the two landmarks based on a line drawn relative to the 3D model.
11. The method of claim 9, wherein determining the planned version and the planned inclination comprises receiving user input and determining the planned version and the planned inclination based on the user input.
12. The method of claim 9, wherein positioning the virtual model of the acetabular cup comprises receiving user input and positioning the virtual model of the acetabular cup based on the user input.
13. The method of claim 9, wherein defining the coronal radiographic plane of the patient comprises defining the coronal radiographic plane based on the 3D model of the patient's pelvis.
14. The method of claim 9, further comprising controlling a robotic device to facilitate implantation of the acetabular cup in accordance with the planned version and the planned inclination.
15. The method of claim 9, comprising determining a mediolateral axis within the 3D model based on positions of the two landmarks; and
determining the longitudinal axis within the 3D model based on the mediolateral axis and the coronal radiographic plane.
16. The method of claim 9, wherein determining the longitudinal axis comprises determining the longitudinal axis as a line substantially transverse to the mediolateral axis and substantially parallel with the coronal radiographic plane.
17. A memory device storing instructions, which, when executed by a controller, cause the controller to perform tasks comprising:
obtaining a three-dimensional (3D) model of a patient's pelvis;
identifying two landmarks of the 3D model of the patient's pelvis;
defining a coronal radiographic plane of the patient;
determining a mediolateral axis of the 3D model based on the two landmarks; and
planning surgical placement of an acetabular cup into an acetabulum by:
positioning a virtual model of the acetabular cup relative to the 3D model, and
determining a planned version and a planned inclination based on the virtual model of the acetabular cup, the mediolateral axis and the coronal radiographic plane.
18. The memory device of claim 17, wherein the tasks further include determining a longitudinal axis within the 3D model based on the mediolateral axis and the coronal radiographic plane.
19. The memory device of claim 18, wherein determining the planned version and the planned inclination comprises calculating an angle between the longitudinal axis and a projection of an acetabular axis onto the coronal radiographic plane.
20. The memory device of claim 18, wherein the tasks further comprise controlling a robotic device to facilitate implantation of the acetabular cup in accordance with the planned version and the planned inclination.
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20
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CROSS-REFERENCE TO RELATED PATENT APPLICATIONS
This application is a continuation of U.S. patent application Ser. No. 15/667,306, filed Aug. 2, 2017, which is a continuation of U.S. patent application Ser. No. 13/178,148, filed Jul. 7, 2011, which claims the benefit of and priority to U.S. Provisional Patent Application No. 61/503,606, filed on Jun. 30, 2011, and U.S. Provisional Patent Application No. 61/442,503, filed on Feb. 14, 2011. All of these applications are incorporated by reference herein in their entireties.
TECHNICAL FIELD
The present disclosure relates generally to computer-assisted surgical procedures, and more particularly, to systems and methods for planning an orientation of a prosthetic device.
BACKGROUND
Computer-assisted surgery (CAS) systems may be used for various surgical applications including hip replacement surgery. For instance, a CAS system may be used in determining the appropriate version and inclination angle of a prosthetic acetabular cup to be implanted into a patient during a surgical procedure on a hip joint. Version and inclination of an acetabular cup can be calculated relative to various anatomic planes and axes. Evidence suggests that it may be advantageous to calculate version and inclination relative to a coronal radiographic plane. Existing CAS methods for calculating version and inclination relative to a coronal radiographic plane often involve intraopertative identification of landmarks on the pelvis which increase patient post-surgical discomfort and/or increase the time required to perform the surgical procedure
Accordingly, there is a need for a simplified system and method to plan and perform a surgical procedure to implant an acetabular cup according to a defined version and inclination relative to a coronal radiographic plane. Moreover, there is a need to enable more accurate calculations of version and inclination with minimal intraoperative manipulations to the patient. Furthermore, there is a need to reduce the overall time that is spent on anesthetizing and performing surgical procedures on the patient.
SUMMARY OF THE DISCLOSURE
In one aspect of the present disclosure, a method of planning and performing a surgical procedure is provided. The method may determine a coronal radiographic plane of a patient based on a medical image of the patient's pelvis, identify two landmarks within the medical image, and determine a version and inclination of a virtual model of an acetabular cup based on a relationship between the virtual model of the acetabular cup, the coronal radiographic plane, and the two landmarks.
In another aspect of the disclosure, a method of planning and performing a surgical procedure is provided. The method may receive a medical image of a patient's pelvis, determine a coronal radiographic plane of the patient based on the medical image, identify two landmarks within the medical image, determine a longitudinal axis based on the two landmarks and the coronal radiographic plane, and determine a version and an inclination of a virtual model of an acetabular cup based on a relationship between the virtual model of the acetabular cup, the coronal radiographic plane, and the longitudinal axis.
In yet another aspect of the disclosure, a system for planning and performing a surgical procedure is provided. The system may include an input device, an output device, and a controller in communication with each of the input device and output device. The controller may be configured to access a medical image of a patient's pelvis, determine a coronal radiographic plane of the patient based on the medical image, identify two landmarks within the medical image, and determine a version and inclination of a virtual model of an acetabular cup based on a relationship between the virtual model of the acetabular cup, the coronal radiographic plane, and the two landmarks.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a graphical view of a pelvis;
FIG. 2 is a schematic view of an exemplary computer-assisted system for determining pelvic tilt;
FIG. 3 is a diagrammatic view of an exemplary method for determining pelvic tilt;
FIG. 4 is a graphical view of an exemplary medical imaging device;
FIG. 5 is a diagrammatic view of a preoperative orientation of an acetabulum; and
FIG. 6 is a diagrammatic view of a planned pose of an acetabular cup.
DETAILED DESCRIPTION
Reference will now be made in detail to specific embodiments or features, examples of which are illustrated in the accompanying drawings. Generally, corresponding reference numbers will be used throughout the drawings to refer to the same or corresponding parts. Although the following disclosure may make certain references to orthopedic procedures involving hip joints, it should be understood that the subject matter described herein may be applicable to other joints in the body, such as, for example, shoulders, elbows, wrists, spines, knees, ankles, and the like.
Referring to FIG. 2, one exemplary embodiment of a computer-assisted surgical (CAS) system 100 which may be used to plan a surgical procedure is provided. As shown, the CAS system 100 may be in direct or indirect communication with one or more medical imaging devices 102 and configured to receive one or more medical images of a patient's anatomy that have been captured by the medical imaging devices 102. More specifically, the CAS system 100 may be configured to receive medical images from a medical imaging device 102 over wired and/or wireless connections, over a network, such as a local area network (LAN), a wide area network (WAN), and the like. The CAS system 100 may also be configured to retrieve medical images that have been captured by a medical imaging device 102 and stored within a database that is either locally or remotely stationed relative to the CAS system 100. The medical imaging devices 102 may include any one or more of a computed tomography (CT) device, a magnetic resonance imaging (MRI) device, an X-ray device, a fluoroscopic imaging device, an ultrasound device, any other device commonly used for medical imaging. The medical image may include a three-dimensional image output from a medical imaging device 102 or a three-dimensional model based on an image or series of images output from a medical imaging device 102.
Still referring to FIG. 2, the CAS system 100 may generally include an input device 105, an output device 106, a memory 108 and a controller 110. The input device 105 may include any one or more of a keyboard, a mouse, a trackball, a touch screen, a touch pad, a microphone, a dial, a switch, a button, a camera, and any other device suited to receive information from a user, such as a surgeon, or the like. The output device 106 may include any one or more of a liquid crystal display (LCD), a cathode ray tube (CRT) display, a plasma screen, a touch screen, and any other device suited to output information to the user. For example, using the input device 105, the user may be able to manipulate orientations and/or views of medical images as well as input parameters that may be required by the CAS system 100. Additionally, using the output device 106, the user may be able to access or view the results of the manipulations as well as any calculations that are performed by the CAS system 100. Furthermore, the memory 108 of the CAS system 100 may be used to locally and at least temporarily store one or more medical images as well as any other data that may be relevant to a particular patient and required by the controller 110. The memory 108 may also be configured to store one or more algorithms or software by which the controller 110 may be operated. In turn, the controller 110 may be configured to electrically communicate with each of the input device 105, output device 106 and the memory 108 and execute tasks according to the algorithms provided.
Turning to FIG. 3, one exemplary algorithm or method 200 by which the controller 110 may operate to plan the version and inclination of a prosthetic acetabular cup 22 is provided. Initially, in step 201, the controller 110 of the CAS system 100 may be configured to receive one or more medical images provided by, for instance, a medical imaging device 102. More specifically, the controller 110 may be configured to access or receive, for instance, a medical image of a patient's pelvis 10, captured while the patient is in the supine position.
In step 202, the controller 110 may be configured to define a coronal radiographic plane 18 based on a plane associated with the medical image. As illustrated in FIG. 4, the medical imaging device 102 may be associated with a device coordinate system 101, and the medical image produced by the medical imaging device 102 may include information relating the image of the anatomy to the device coordinate system 101. In certain embodiments, the device coordinate system 101 may relate directly to the coordinate system of the medical image. In the embodiment illustrated in FIG. 4, the x-y plane of the device coordinate system 101 is substantially parallel to a surface plane 103, which is defined by the surface of a table 104, or other patient supporting structure, on which a patient lies in a supine position while the medical imaging device 102 captures the medical image of a portion of the patient's anatomy. More particularly, the x-axis may run substantially along the width of the table 104 and may be similar in orientation to a mediolateral axis 16 of the patient, and the y-axis may run substantially along the length of the table 104 and may be similar in orientation to a longitudinal axis 17 of the patient. Thus, according to the embodiment illustrated in FIG. 4, the controller 110 may be able to identify the surface plane 103 as the x-y plane of the medical image, which relates directly to the x-y plane of the device coordinate system 101. In another embodiment, known information regarding the physical structure of the medical imaging device 102, as it relates to the structure and content of the data in the medical image, may be used to transform a plane represented in the medical image that is not substantially parallel to the surface of the table 104 into a plane that is substantially parallel to the surface of the table 104. In yet another embodiment, the medical images provided to the controller 110 may include information from which the controller 110 can determine the surface plane 103 or other plane substantially parallel with the surface of the table 104, or other patient supporting structure, on which a patient lies in a supine position while the medical imaging device 102 captures the medical image of a portion of the patient's anatomy. Such information could include, for example, image data that is captured in the medical image and is representative of the surface of the table 104. In yet another embodiment, the controller 110 may be configured to manually receive information pertaining to the surface plane 103 from a user through the input device 105, such as, for example, a user manually selecting multiple points representing the surface of the table 104 in the medical image. The controller 110 may then designate the surface plane 103, or a plane parallel thereto, as the coronal radiographic plane 18. Thus, in at least one embodiment, the coronal radiographic plane 18 is defined as the x-y plane of the device coordinate system 101.
In step 203, the controller 110 may be configured to identify a plurality of landmarks within the medical image of the pelvis 10. For instance, the controller 110 may be configured to identify two anterior-superior iliac spines 12 of the pelvis 10, as shown in FIG. 1. The controller 110 may be configured to receive information pertaining to the respective locations of the anterior-superior iliac spines 12 from a user. For example, a user viewing the medical images of the pelvis 10 at the output device 106 may visually locate and manually input the locations of one or both of the anterior-superior iliac spines 12 into the controller 110 via the input device 105. In another embodiment, the controller 110 may be configured to automatically detect and extract information pertaining to the locations of the anterior-superior iliac spines 12 of the pelvis 10 using image detection and/or other related schemes on the medical images. While the embodiments described herein discuss the use of the two iliac spines 12 of the pelvis 10, various pairs of landmarks within the patient's anatomy that are generally known to be substantially symmetrical about a median plane of the patient's anatomy may be alternatively used, such as the two ischial spines of the pelvis 10.
In step 204 of the algorithm 200 of FIG. 3, the controller 110 may be configured to determine a mediolateral axis 16 of the pelvis 10 based on the positions within the medical image of the landmarks determined in step 203. More specifically, the controller 110 may generate a line that intersects each of the landmarks, such as the two anterior-superior iliac spines 12, and designate the resulting line as the mediolateral axis 16, as illustrated in FIG. 1. In one embodiment, the mediolateral axis 16 may be manually identified to the controller 110 by the user. For example, while viewing the medical images of the pelvis at the output device 106, the user may manually identify the line that intersects each of the anterior-superior iliac spines 12 using the input device 105. Once identified, the controller 110 may designate the line as the mediolateral axis 16. In an alternative embodiment, the controller 110 may be configured to automatically detect the mediolateral axis 16 by calculating the line of intersection between each of the identified landmarks of the pelvis 10. In still further alternatives, the controller 110 may be configured to determine at least one vector based on the anterior-superior iliac spines 12 determined in step 203. For instance, once the anterior-superior iliac spines 12 of the pelvis 10 have been identified, the controller 110 may form a three-dimensional vector extending between or intersecting both of the anterior-superior iliac spines 12 to form the mediolateral axis 16.
Once the mediolateral axis 16 has been determined, the controller 110 in step 205 may be configured to determine a longitudinal axis 17 relative to the medical image of the pelvis 10, as illustrated in FIG. 1. The controller 110 may determine the longitudinal axis 17 as a line that is substantially transverse to the mediolateral axis 16 and substantially parallel with, or contained in, the coronal radiographic plane 18. The longitudinal axis 17 may also be constrained to intersect with the mediolateral axis 16 at a midpoint between the two landmarks, for example the two iliac spines 12. In another embodiment, step 205 may include applying a correction to the radiographic coronal plane 18 based on the determined mediolateral axis 16. In particular, with reference to the embodiment in which the coronal radiographic plane is defined as the x-y plane of the device coordinate system 101, as discussed in association with FIG. 4, a unit vector having the orientation of the x-axis in the device coordinate system 101 may be crossed with a unit vector having the same orientation as the mediolateral axis 16 to produce a rotation vector. In this embodiment, the radiographic coronal plane 18 may be rotated about the rotation vector until the x-axis of the coronal radiographic plane is parallel to, or collinear with, the mediolateral axis 16.
In step 206, the controller 110 may be configured to determine a preoperative acetabular version (αpre). The controller 110 may determine a patient's acetabular axis 21 based on the patient's acetabulum 20, as illustrated in FIG. 1, according to various methods that are known in the art. The patient's preoperative version (αpre) may then be determined as the angle between the acetabular axis 21 and the coronal radiographic plane 18, as illustrated in FIG. 5.
In step 207 the controller 110 may be configured to determine a preoperative acetabular inclination (θpre). The preoperative acetabular inclination (θpre) may be determined as the angle between the longitudinal axis 17 and the projection of acetabular axis 21 onto the coronal radiographic plane 18, as illustrated in FIG. 5.
With reference to FIG. 6, in step 208 the controller 110 may be configured to plan a pose to implant the acetabular cup 22 into a patient's pelvis 10. As used herein, “pose” means position and orientation. The acetabular cup 22 may have an acetabular cup axis 23 associated with it. The acetabular cup axis 23 may be pass through the center of the acetabular cup 23, and may be substantially normal to the center of the acetabular cup 23 and/or the rim of the acetabular cup 23. The acetabular cup axis 23 may also be determined based on other methods that may be known in the art. In this step a user may position a virtual model of the acetabular cup 22 relative to the medical image of the patient's pelvis 10 by way of the input device 105. Based on the orientation of the virtual model of the acetabular cup 22, the controller 110 may then determine a planned version (αplan) and inclination (θplan) for the acetabular cup 22, and the planned version (αplan) and inclination (θplan) may be provided to a user by way of the output device 106. As illustrated in FIG. 6, the planned version (αplan) may be determined as the angle between acetabular cup axis 23 and coronal radiographic plan 18. The planned inclination (θplan) may be determined as the angle between longitudinal axis 17 and the projection of the acetabular cup axis 23 onto the coronal radiographic plane 18.
Alternatively, the controller 110 may be configured to receive the planned version (αplan) and inclination (θplan) and constrain the virtual model of the acetabular cup 22 accordingly. According to this alternative embodiment, a user may input a desired planned version (αplan) and inclination (θplan) by way of the input device 105, and the controller 110 would use these values to constrain the orientation of the virtual model of the acetabular cup 22, while allowing the user to adjust the position of the virtual model of the acetabular cup 22 relative to medical image of the pelvis 10.
In step 209, the controller 110 may be configured to guide a reamer to prepare the acetabulum 20 such that the implanted acetabular cup 22 is substantially oriented according to the planned version (αplan) and inclination (θplan) of the acetabular cup 22. This may be accomplished, for example, by providing surgical navigation and haptic feedback to a user manipulating the reamer, as described in U.S. Patent Application Publication US 2011/0082468, which is hereby incorporated by reference.
In step 210, the controller 110 may be configured to guide a user during placement and impaction of the acetabular cup 22 to substantially achieve the planned version (αplan) and inclination (θplan) of the acetabular cup 22. This may be accomplished, for example, by providing surgical navigation and haptic feedback to a user manipulating an impactor tool, as further described in U.S. Patent Application Publication US 2011/0082468.
In step 211, the controller 110 may be configured to determine the pose of the acetabular cup 22 after impaction into the pelvis 10 as described in U.S. Patent Application Publication US 2011/0082468. The controller may then use the post-impaction pose of the acetabular cup 22 relative to the pelvis 10 to determine a post-impaction version (αpost) and inclination (θpost) of the acetabular cup in a manner similar to that discussed in step 208. The post-impaction version (αpost) and inclination (θpost) may then be displayed to a user by way of the output device 106.
While only certain embodiments have been set forth for the purposes of illustration, alternatives and modifications will be apparent from the above description to those skilled in the art. These and other alternatives are considered equivalents and within the scope of this disclosure and the appended claims.
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16705423
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mako surgical corp.
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USA
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B2
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Utility Patent Grant (with pre-grant publication) issued on or after January 2, 2001.
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Open
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Apr 20th, 2022 02:51PM
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Apr 20th, 2022 02:51PM
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Stryker
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Health Care
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Health Care Equipment & Services
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nyse:syk
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Stryker
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Apr 19th, 2022 12:00AM
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Mar 3rd, 2015 12:00AM
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https://www.uspto.gov?id=US11304592-20220419
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Relay lens system for broadband imaging
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An optical system includes a first relay rod of a first material, a second relay rod of a second material, different from the first material, and a lens between the first and second relay rods.
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11304592
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1. An optical system, comprising:
a first relay rod of a first material, the first relay rod having no optical power;
a second relay rod of a second material, different from the first material, the second relay rod having no optical power, wherein the first and second relay rods are geometrically symmetric to one another relative to a pupil or conjugate pupil of the optical system, the first and second relay rods having a same length; and
a lens between the first and second relay rods, wherein the lens includes a first relay objective and a second relay objective that have a same design and material.
2. The optical system as claimed in claim 1, wherein the first and second materials are selected to reduce the wavefront error across the field of view of the optical system as compared with using a same material for both the first and second relay rods.
3. The optical system as claimed in claim 1, wherein a pupil region of the system is in air.
4. The optical system as claimed in claim 1, further comprising:
a third relay rod of a third material;
a fourth relay rod of a fourth material, the fourth material being different from the third material; and
a lens between the third and fourth relay rods.
5. The optical system as claimed in claim 4, wherein the first and third materials are the same and the second and fourth materials are the same.
6. The optical system as claimed in claim 1, further comprising a detector to detect light from 460 nm to 850 nm.
7. An endoscope including the optical system as claimed in claim 1.
8. The optical system as claimed in claim 1, wherein the first and second relay rods and the lens has refractive index symmetry and Abbe number asymmetry about a pupil region.
9. A kit, comprising:
a first relay rod of a first material, the first relay rod having no optical power;
a second relay rod of a second material, different from the first material, the second relay rod having no optical power, wherein the first and second relay rods are geometrically symmetric to one another relative to a pupil or conjugate pupil of the optical system, the first and second relay rods having a same length; and
a lens to be inserted between the first and second relay rods, wherein the lens includes a first relay objective and a second relay objective that have a same design and material.
10. The kit as claimed in claim 9, wherein the lens includes a first relay objective and a second relay objective.
11. The kit as claimed in claim 10, wherein the first and second relay objectives have a same design and material.
12. The kit as claimed in claim 9, wherein the first and second relay rods and the lens has refractive index symmetry and Abbe number asymmetry about a pupil region.
13. A method of compensating for dispersion in a relay lens system, the method comprising:
providing a first relay rod of a first material, the first relay rod having no optical power;
providing a second relay rod of a second material, different from the first material, the second relay rod having no optical power, wherein the first and second relay rods are geometrically symmetric to one another relative to a pupil or conjugate pupil of the optical system, the first and second relay rods having a same length; and
providing a lens between the first and second relay rods, wherein the lens includes a first relay objective and a second relay objective that have a same design and material.
14. The method as claimed in claim 13, wherein the first and second relay rods and the lens has refractive index symmetry and Abbe number asymmetry about a pupil region.
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14
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CROSS-REFERENCE TO RELATED APPLICATION
This application is related to U.S. Provisional Application No. 61/947,776, filed Mar. 4, 2014, and U.S. Provisional Application No. 62/084,292 filed Nov. 25, 2014, the disclosures of which are incorporated herein by reference.
TECHNICAL FIELD
The present disclosure relates generally to the field of optical lens systems. More specifically, the disclosure relates to rod-type relay lens systems for use in broadband imaging.
BACKGROUND
Medical endoscopes are used to view internal body organs and tissue through small openings created in and through the body wall or skin or by way of existing openings or orifices. For example, fluorescence endoscopy is an endoscopic examination method in which fluorescent dye is administered to patients and excited with light having a specific excitation wavelength. The excited fluorescent dye emits light of a specific emission wavelength, which is longer than the excitation wavelength, so that visualization of tissue and/or vessels containing the dye can be enhanced relative to conventional white-light endoscopy.
SUMMARY
One or more embodiments are directed to an optical system, including a first relay rod of a first material, a second relay rod of a second material, different from the first material, and a lens between the first and second relay rods.
The first and second materials may be selected to reduce the wavefront error across the field of view of the optical system as compared with using a same material for both the first and second relay rods.
The first and second relay rods may have no optical power.
The first and second relay rods may have no optically powered surfaces.
The first and second relay rods may be geometrically symmetric to one another relative to a pupil or conjugate pupil of the optical system.
The lens may include a first relay objective and a second relay objective.
The first and second relay objectives may have a same design and material.
A pupil region of the system may be in air.
The optical system may include a third relay rod of a third material, a fourth relay rod of a fourth material, the fourth material being different from the third material; and a lens between the third and fourth relay rods.
The first and third materials are the same and the second and fourth materials may be the same.
The optical system may include a detector to detect light from 460 nm to 850 nm.
The optical system may be in an endoscope.
One or more embodiments are directed to a kit including a first relay rod of a first material, a second relay rod of a second material, different from the first material, and a lens to be inserted between the first and second relay rods.
The lens may include a first relay objective and a second relay objective.
The first and second relay objectives have a same design and material.
One or more embodiments are directed to a method of compensating for dispersion in a relay lens system, the method including providing a first relay rod of a first material, providing a second relay rod of a second material, different from the first material, and providing a lens between the first and second relay rods.
BRIEF DESCRIPTION OF THE DRAWINGS
Features will become apparent to those of skill in the art by describing in detail exemplary embodiments with reference to the attached drawings in which:
FIGS. 1A and 1B illustrate a relay pair according to an embodiment;
FIG. 1C illustrates a plurality of relay pairs;
FIG. 2 illustrates how index and Abbe values interplay through a relay set;
FIG. 3 is a graph of refractive index versus wavelength for exemplary glass types;
FIG. 4 is a graph illustrating partial dispersion versus inverse dispersion for various glass types;
FIG. 5 is graph illustrating refractive index versus Abbe number for exemplary glasses; and
FIGS. 6A to 6C illustrate plots of MTF versus spatial frequency for comparative examples and an example according to an embodiment.
DETAILED DESCRIPTION
Example embodiments will now be described more fully hereinafter with reference to the accompanying drawings; however, they may be embodied in different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey exemplary implementations to those skilled in the art. Generally, corresponding or similar reference numbers will be used, when possible, throughout the drawings to refer to the same or corresponding parts.
Optical design requirements for endoscopes have changed with the introduction of new technologies, such as image sensors and solid state illumination. An endoscope designed for visual use only may be optimized for F,d,C light, which spans the region of 486 nm through to 656 nm. An endoscope designed for machine vision, where a camera will display an image on a monitor, may operate with illumination wavelengths extending further into the blue, for example to 460 nm. Additionally, there is demand to visualize tissue and body structures in other waveband regimes beyond that of visible bands, e.g., near infrared regions (700 nm to 900 nm) where tissue is maximally transparent to light and where dyes such as Indocyanine Green (ICG) fluoresce and are used as markers. Additionally, the resolution required of endoscopes has increased with the introduction of high definition (HD) video image sensors having smaller and more numerous pixels than earlier NTSC or PAL formats. In both diagnostic and therapeutic procedures where endoscopes are used, it is advantageous to provide guiding imagery and fluorescent markers. Accordingly, high resolution imaging is desired in the visible bands as well as in longer wavelength regions beyond that of human vision.
Imaging optical systems, including endoscopes, must be designed with the operational wavelengths in mind. The refractive properties of materials are such that light of different wavelengths will propagate along slightly different paths through an optical system, and arrive at slightly different image planes. In order to ensure that the image planes for different wavelengths are sufficiently close so as not to degrade image quality, the design of the system must take into consideration these refractive properties.
A system designed for use across a broadband of wavelengths, e.g., between 460 nm to 850 nm, may have one or more image sensors. If the system has two sensors, e.g., one for the visible region and one for the near infrared region, then the design of the system may consider separately the problems of image quality for the visible and image quality for the near infrared region, since each region will have its own corresponding sensor. If however, the system operates with a single image sensor, then the system must focus all light throughout its operational waveband onto one image plane. This latter condition is more difficult, but also offers more utility to the remainder of the design, as a single sensor maybe used.
A system designed for broadband use, for example visible and near infrared, and designed for single sensor operation, requires tight control over chromatic aberrations, such as axial color. Light of different wavelengths focus at different distances from the optics. Axial color arises from dispersion, i.e., the variation of refractive index versus wavelength in refractive materials. Sensitivity to dispersion increases as the f/#is faster.
Therefore, one or more embodiments is directed to providing a relay lens system that offsets the effect of dispersion as light propagates through the system, as discussed in detail below.
FIGS. 1A and 1B illustrate an exemplary relay pair 100 for a broadband system using a single detector. FIG. 1A illustrates the on-axis beam and FIG. 1B illustrates the off-axis beam. FIG. 1C illustrates an odd number of relay pairs to produce an upright image at a detector 200. In particular, the image after an objective lens 10 in inverted, so any odd number of relay pairs, e.g., 1, 3, 5, 7, and so forth, will produce an upright image.
The relay pair includes a first relay rod lens assembly 110 and a second relay rod lens assembly 120. Each of the first and second relay rod lens assemblies 110, 120 includes a rod 116, 126, respectively, and a plurality of bonded lenses selected to provide color correction from a lower limit, e.g., 460 nm, to an upper limit, e.g., 850 nm. In particular, the bonded lenses may include a relay field lens 102 and a relay objective 104, here both shown as doublets.
The rods 116, 126 are made of different materials that compensate for residual wavefront error in the relay pair 100 as illustrated in FIG. 2. The diffraction-limited relay pair in FIG. 2 illustrates refractive index symmetry about the pupil region P, and Abbe number asymmetry about the pupil region P.
The relay pair 100 operates with unit magnification. The bonded lenses of the relay rod lens assemblies 110 and 120 are symmetric or mirrored about a pupil (or aperture stop) 130 between the first and second relay rod assemblies 110, 120. In other words, the relay field lenses 102 and the relay objectives 104 are the same, i.e., the same material, the same prescription, and so forth, throughout the relay pair 100.
Although a design is optimized based on wavefront error and MTF performance, and although this process will offset some aberrations through constructive introduction of other aberrations, it may be helpful to explore the problem in traditional terms, such as may be found by considering the system in terms of Seidel errors. While typical, symmetrical design of the relay pair will correct for odd Seidel aberrations, e.g., coma, distortion, lateral chromatic aberration, and so forth, even Seidel aberrations, e.g., spherical, astigmatism, field curvature, axial chromatic, and so forth, are not corrected by such symmetry. Axial chromatic aberration is of particular concern as the wavelength bandwidth increases, while the image plane remains constrained to a single detector. Additional lenses or different lenses on different sides of the relay pupil may be used to correct for the dispersion, but this increases cost and complexity.
However, by using different materials for the relay rod in the first and second relay rod lens assemblies 110, 120 in accordance with an embodiment, the basic form of the relay pair 100 may be maintained. In other words, since the material of the relay rods introduce dispersion themselves, by selecting appropriate materials for the relay rods 116, 126 in the first and second relay rod lens assemblies 110, 120, the dispersion over the relay pair 100 may be compensated, while otherwise using the same elements throughout the relay pair 100. The relay rod carries no optical power, but instead is used to make the space between powered elements appear to have a shorter optical path distance, without using total internal reflection.
Thus, by treating the material of the relay rod as another degree of freedom, dispersion in the relay pair 100 may be altered, i.e., corrected, without modifying the basic form. The relay rod lens assemblies 110 and 120 will have nearly identical focal lengths in order to meet the required unit magnification. The first rod 116 and the second rod 126 are symmetrical to one another relative to the pupil. However, as noted above, the first rod 116 is made of a first glass type and the second rod 126 is made of a second glass type. The second glass type is different from the first glass type. In design, the first glass type and the second glass type are selected to reduce residual wavefront error within the optical system. Otherwise, the pair of relay and rod lens assembly is identically configured, e.g., identical lengths, identical lens elements, identical geometric form, and so forth, while using different rod materials.
Referring to FIG. 3, it can be seen that for any wavelength, different materials have different local tangents (derivatives). Thus, glass materials not only exhibit different aggregate dispersion (different inverse Abbe numbers) but also exhibit different partial dispersion, which is a measure of dispersion over a subset of the bandwidth. FIG. 4 illustrates how partial dispersion (Pg,F) varies with inverse dispersion (Abbe number or Vd) for SCHOTT®'s optical glass assortment.
Relay rod glass material is selected first for its transmission properties; a designer may build a design-specific list of materials ranked according to transmission, then draw upon the top candidates for their remainder attributes (such as index, dispersion, thermal coefficient, etc). In general, optical glasses that are reasonably well suited for use in relay rods tend to occur at abbe numbers between 35 and 65, and indices of refraction between 1.5 and 1.65 (refer to the plot of refractive index versus Abbe number of FIG. 5, in which some suitable glasses made by SCHOTT® with Abbe numbers between 50 and 65 include, e.g., N-PSK3, N-BALF5, N-SK2, N-BAK2, N-K5 and N-KF9). Glasses that will form the outer elements may be then selected based on other design requirements, such as their thermal coefficients relative to their neighbor glass on the other side of a lens bond. Optimization for minimum wavefront error across all field positions will drive the form to be symmetric about the pupil in regard to index of refraction, and asymmetric about the pupil in regard to Abbe number (or inverse dispersion). An example of a diffraction-limited solution is illustrated in FIG. 2. The outer elements, i.e., the relay objectives and field lenses will be the same on both sides of the relay pupil. The focal lengths for each relay rod lens assembly are nearly identical, but the partial dispersions of the relay rod lens assemblies due to the different rod materials have compensatory effects on residual wavefront error.
FIGS. 6A to 6C illustrate dispersion in a comparative example and an example according to an embodiment. FIG. 6A shows a plot of the modulus of the optical transfer function (OTF) (MTF) versus spatial frequency in cycles per mm for an F/4.5 relay in which the same material, here N-PSK3, is used for both relay rods in a relay system for a 30 cm visible-near infrared endoscope having three relay pairs. FIG. 6B shows a plot of MTF versus spatial frequency in which elements of the same relay system as used for FIG. 6A are used, except the same material for the relay rods is N-BALF5. FIG. 6C shows a plot of MTF versus spatial frequency in which elements of the same relay system as used for FIG. 6A are used, except different materials are used for the relay rods on opposite sides of the relay pupil. For example, a first material, here N-PSK3, is used for the first relay rod, and a second material, here N-BALF5, is used for the second material. The comparing FIGS. 6A to 6C, the MTF for the transverse off-axis ray is significantly improved by use two different materials for the relay rods.
By way of summation and review, endoscopes typically include a long, thin, rigid or semi-rigid optical cylinder that is mounted on or to a viewing mechanism or imager. When the endoscope is inserted and positioned for use, an image of the object being viewed is formed by an objective lens at the inserted or distal end of the endoscope. The image passes through a relay lens system, comprising of one or more sets of relay lenses, along the cylinder to a viewer comprising an eyepiece or viewing lens or a video camera or imager at the viewing or proximal end of the endoscope.
A relay lens system will reconstruct the image formed at the objective lens one or more times, depending on the number of relays used. A single relay will form one image. Additional relays may be used to form additional images. The purpose of these elements is not to produce many images, but rather to carry the image field to another position. Endoscopes are narrow in order to reduce the size of an incision. Endoscopes are long because the object under study may be deep within the body. The image formed by the objective lens at the distal end is relayed along the length of the endoscope to the proximal end by the relay lens system.
When used in endoscopes, the relay lenses may be very narrow, e.g., less than 6.5 mm in diameter and approximately 20 mm to 50 mm long. Most endoscopes require three or more sets of relay lenses for proper operation. The number of lenses generally depends on the length and specific requirements of the particular endoscope and/or the application for which it is intended. Because the objective and each relay set is producing an image with unit magnification which is turned upside down, and because a standard endoscope should produce an upright image, usually an odd number of relay lenses are used so that the image produced by the optical system at the ocular or at the detector, is upright.
For good image quality, the optical system of an endoscope should be well corrected for the major lens aberrations. A relay lens typically operates with unit magnification with lenses configured to be symmetric about the relay's internal stop plane, i.e., the pupil within the relay. This set of conditions will result in the odd Seidel aberrations formed by the lenses before the relay's pupil to be cancelled out by the lenses after the relay's pupil. However, the even Seidel aberrations are not corrected. As noted above, these even Seidel aberrations may become more problematic as an operational waveband over which the optical system is to perform increases.
According to an embodiment discussed above, using different materials for relay rods on opposite sides of the relay pupil may allow dispersion to be compensated without changing the basic form of the relay. In other words, by using different rod materials on opposite sides of the relay pupil, other elements, e.g., objectives and field lenses, on opposite sides of the relay pupil may be identical, such that the pair of relay rod lens assemblies are otherwise identically configured, e.g., identical lengths, identical lens elements, identical geometric form, and so forth, while using different rod materials.
Example embodiments have been disclosed herein, and although specific terms are employed, they are used and are to be interpreted in a generic and descriptive sense only and not for purpose of limitation. In some instances, as would be apparent to one of ordinary skill in the art as of the filing of the present application, features, characteristics, and/or elements described in connection with a particular embodiment may be used singly or in combination with features, characteristics, and/or elements described in connection with other embodiments unless otherwise specifically indicated. Accordingly, it will be understood by those of skill in the art that various changes in form and details may be made without departing from the spirit and scope of the present invention as set forth in the following claims. For example, while specific examples have been directed to endoscopes, embodiments may be used with other imaging system with similar waveband and single detector requirements, e.g., borescopes.
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14636448
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stryker european operations limited
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USA
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B2
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Utility Patent Grant (with pre-grant publication) issued on or after January 2, 2001.
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Open
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Apr 20th, 2022 02:51PM
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Apr 20th, 2022 02:51PM
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Stryker
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Health Care
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Health Care Equipment & Services
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nyse:syk
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Stryker
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Apr 19th, 2022 12:00AM
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Sep 4th, 2019 12:00AM
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https://www.uspto.gov?id=US11306758-20220419
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Connecting member and connecting method for redirecting flowable material
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A connecting member includes a fastening portion configured to be fastened to an object by an adhesive. The connecting member includes at least one supply opening for supplying the adhesive and at least one discharge opening for discharging a part of the adhesive, wherein the at least one supply opening and the at least one discharge opening are arranged outside of a fastening portion or at least outside of a fastening area. A channel connecting the at least one supply opening and the at least one discharge opening is configured to direct the flow of adhesive. The channel includes an open channel portion that at least partly extends on a surface of the fastening portion and that comprises at least one redirecting portion configured to redirect the flow of adhesive between the at least one supply opening and the at least one discharge opening.
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11306758
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1. A connecting member, comprising:
a fastening portion configured to be fastened to an object by an adhesive, wherein the fastening portion comprises a fastening area configured to come into contact with the object to be fastened;
at least one supply opening for supplying the adhesive and at least one discharge opening for discharging a part of the adhesive, wherein the at least one supply opening and the at least one discharge opening are arranged outside of the fastening portion or at least outside of the fastening area; and
a channel connecting the at least one supply opening and the at least one discharge opening and configured to direct a flow of the adhesive, wherein the channel comprises at least one open channel portion that at least partly extends on a surface of the fastening portion and that comprises at least one redirecting portion configured to redirect the flow of the adhesive between the at least one supply opening and the at least one discharge opening,
wherein the at least one open channel portion comprises at least one helical portion, wherein a first helical portion of the at least one helical portion is connected to the at least one redirecting portion and wherein a second helical portion of the at least one helical portion is connected to the at least one redirecting portion.
2. The connecting member according to claim 1, wherein the connecting member has an axial extension, and wherein the redirecting portion is axially located on a same side of the at least one supply opening and of the at least one discharge opening with respect to the axial extension of the connecting member.
3. The connecting member according to claim 1, wherein the at least one open channel portion extends on an outer circumferential surface of the fastening portion or on an inner circumferential surface of the fastening portion.
4. The connecting member according to claim 3, wherein the fastening area is formed by the outer circumferential surface or the inner circumferential surface of the fastening portion.
5. The connecting member according to claim 1, wherein the at least one channel includes a first internal channel portion and a second internal channel portion, both extending within the body of the connecting member.
6. The connecting member according to claim 5, wherein the first internal channel portion connects the at least one supply opening to the open channel portion, and wherein the second internal channel portion connects the at least one open channel portion and the at least one discharge opening.
7. The connecting member according to claim 1, wherein the at least one redirecting portion has a U-shape.
8. The connecting member according to claim 1, wherein the at least one supply opening and the at least one discharge opening are included in at least one plane, which extends perpendicular to a longitudinal axis of the fastening portion.
9. The connecting member according to claim 8, wherein the at least one plane is spaced apart from the fastening portion.
10. The connecting member according to claim 1, wherein the at least one supply opening and the at least one discharge opening are separated from the fastening portion by a step-like portion defining an abutment surface for an abutment of the object to be fastened to the fastening portion of the connecting member.
11. The connecting member according to claim 1, wherein the fastening portion has a cylindrical shape and is configured to be connected to the object having a rod, duct or tube shape.
12. The connecting member according to claim 1, wherein the connecting member comprises an attachment portion for attachment of an object to be connected to the other object by means of the connecting member.
13. A connecting member, comprising:
a fastening portion configured to be fastened to an object by an adhesive, wherein the fastening portion comprises a fastening area configured to come into contact with the object to be fastened;
at least one supply opening for supplying the adhesive and at least one discharge opening for discharging a part of the adhesive, wherein the at least one supply opening and the at least one discharge opening are arranged outside of the fastening portion or at least outside of the fastening area; and
a channel connecting the at least one supply opening and the at least one discharge opening and configured to direct a flow of the adhesive, wherein the channel comprises at least one open channel portion that at least partly extends on a surface of the fastening portion and that comprises a redirecting portion configured to redirect the flow of the adhesive coming from the at least one supply opening to the at least one discharge opening,
wherein the at least one open channel portion comprises at least one helical portion, a first helical portion of the at least one helical portion is connected to the at least one redirecting portion and wherein a second helical portion of the at least one helical portion is connected to the at least one redirecting portion.
14. A connecting method for connecting a connecting member with an object by an adhesive, wherein the connecting member comprises:
a fastening portion configured to be fastened to the object by the adhesive, wherein the fastening portion comprises a fastening area configured to come into contact with the object to be fastened;
at least one supply opening for supplying the adhesive and at least one discharge opening for discharging a part of the adhesive, wherein the at least one supply opening and the at least one discharge opening are arranged outside of the fastening portion at least outside of the fastening area; and
a channel connecting the at least one supply opening and the at least one discharge opening and configured to direct a flow of the adhesive, wherein the channel comprises at least one open channel portion that at least partly extends on a surface of the fastening portion and that comprises at least one redirecting portion configured to redirect the flow of the adhesive between the at least one supply opening and the at least one discharge opening, wherein the at least one open channel portion comprises at least one helical portion, a first helical portion of the at least one helical portion is connected to the at least one redirecting portion and wherein a second helical portion of the at least one helical portion is connected to the at least one redirecting portion,
wherein the method comprises the steps of:
arranging the fastening portion of the connecting member at the object such that the at least one open channel portion is covered by a surface of the object to form a closed channel portion;
supplying the adhesive via the at least one supply opening to the channel of the connecting member, wherein the adhesive flows through a first internal channel portion, the closed channel portion and a second internal channel portion to the at least one discharge opening, wherein the adhesive in the closed channel portion comes into contact with both the connecting member and the object, to establish an adhering connection between the connecting member and the object; and
stopping adhesive supply when the adhesive leaks out the at least one discharge opening.
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14
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CROSS-REFERENCE TO RELATED APPLICATIONS
This application claims priority to European Patent Application No. 18192685.8, filed Sep. 5, 2018, which is hereby incorporated by reference in its entirety.
TECHNICAL FIELD
The present disclosure generally relates to a connecting member. In particular, a connecting member for establishing a connection between a first object and at least one second object is presented.
BACKGROUND
A connecting member for establishing a connection between two objects can be fastened to a first one of the objects by means of an adhesive. The connecting member comprises a further portion for attaching a second one of the objects to the connecting member so that a connection is established between the two objects by means of the connecting member. In addition to the fastening the first object to the connecting member by means of the adhesive, the connecting member thus comprises a further connecting structure like a threaded portion to fasten the second object to the connecting member.
Such connecting members are, for example, disclosed in U.S. Pat. No. 8,419,331 B2. U.S. Pat. No. 8,419,331 B2 discloses a composite anchor bolt having a tapered tip for facilitating the introduction of the anchor bolt into a borehole. The anchor bolt has thread turns arranged parallel to each other at the shaft of the anchor bolt. The anchor bolt is screwed into the borehole which is provided with a quantity of glue. The glue becomes distributed between the bolt and a wall of the borehole.
SUMMARY
There is a need for a connecting member that improves the fastening of the connecting member to an object by means of an adhesive.
According to one aspect of the present disclosure, a connecting member is provided. The connecting member comprises a fastening portion configured to be fastened to an object by means of an adhesive. The fastening portion comprises a fastening area configured to come into contact with the object to be fastened. The connecting member further comprises at least one supply opening for supplying the adhesive and at least one discharge opening for discharging a part of the adhesive, wherein the at least one supply opening and the at least one discharge opening are arranged outside of the fastening portion or at least outside of the fastening area. A channel connects the at least one supply opening and the at least one discharge opening and is configured to direct a flow of the adhesive. The channel comprises an open channel portion that at least partly extends on a surface of the fastening portion and that comprises at least one redirecting portion configured to redirect the flow of adhesive between the at least one supply opening and the at least one discharge opening.
The connecting member may have an axial extension. The redirecting portion may be located on the same side (e.g., to the left or to the right) of the at least one supply opening and of the at least one discharge opening with respect to the axial extension of the connecting member.
The redirecting portion may be located at or close to an axial end of the axial extension of the connecting member. The at least one supply opening and the at least one discharge opening may be arranged offset from the axial end of the axial extension of the connecting member, at which the redirecting portion is located. The at least one supply opening and the at least one discharge opening may be displaced relative to the redirecting portion by the same offset. The at least one supply opening and the at least one discharge opening may be arranged at a centrally located portion of the axial extension of the connecting member.
The at least one open channel portion may have at least one portion having a particular geometrical shape configured for leading the adhesive along the outer surface of the fastening portion. Such a portion may have, for example, a meandering or thread-like shape. The at least one open channel portion may have at least one helical portion. A first helical portion may be connected to the at least one redirecting portion. The first helical portion may extend in a direction of the at least one supply opening. The first helical portion may direct the flow of the adhesive coming from the at least one supply opening to the at least one redirecting portion.
Alternatively or in addition to a helical portion, the open channel portion may comprise at least one meandering portion. The meandering portion may include straight sections and curved sections connecting at least two straight sections with each other. The straight sections may extend in a direction of the longitudinal axis of the fastening portion. The straight sections may extend substantially parallel to the longitudinal axis of the fastening portion. The straight sections may extend substantially parallel to each other. Each of the curved sections may be arranged at or close to one of the axial ends of the fastening portion. The curved sections may have a U-shape.
The curved sections may be configured to direct the flow of adhesive coming from one straight section into the next straight section. In other words, the curved sections are arranged and configured to redirect the flow of adhesive. Each of the curved sections forms a redirecting portion. The adhesive coming from the at least one supply opening may, for example, flow through a straight section of the meandering portion and from this straight section into the curved section. The curved section directs the flow of adhesive into the next straight section, which is in turn connected by a curved section to the next straight section. The flow direction of the flow of adhesive in two neighbouring or subsequent straight sections may be opposite.
A second helical portion may be connected to the at least one redirecting portion. The second helical portion may extend in a direction of the at least one discharge opening. The second helical portion may direct a flow of the adhesive coming from the redirecting portion in direction of the at least one discharge opening.
The at least one open channel portion may extend on an outer circumferential surface of the fastening portion. The at least one open channel portion may extend on an inner or an outer circumferential surface of the fastening portion. The circumferential surface may be defined by a cylindrical body or space of any cross-sectional form (e.g., of a circular cross-sectional form).
The connecting member may be fastened to objects having different shapes and/or dimensions. Depending on the shape and/or dimensions of the object, to which the connecting member should be fastened, the at least one open channel portion may be configured to extend on an outer circumferential surface of the fasting portion or an inner circumferential surface of the fastening portion. In case that the open channel portion extends on an outer circumferential surface, the fastening portion may be inserted into the object for fastening the connecting member to the object. On the other hand, in case the open channel portion extends on an inner circumferential surface, a portion of the object, to which the connecting member should be fastened, may be received within the fastening portion of the connecting member.
The at least one channel may include a first internal channel portion and a second internal channel portion. The first internal channel portion and the second internal channel portion may extend within the body of the connecting member. The first internal channel portion may connect the at least one supply opening to the open channel portion. The second internal channel portion may connect the at least one open channel portion and the at least one discharge opening.
The first internal channel portion and the second internal channel portion may each have a section extending substantially radially inwardly starting from the at least one supply opening and the at least one discharge opening, respectively. The first internal channel portion and the second internal channel portion each may have a second section connected to the first section, which second section may extend substantially outwardly in radial direction. The second section may connect the first section of each of the at least one first internal channel portion and the second internal channel portion with the at least one open channel portion.
The at least one redirecting portion may have a shape configured to redirect the flow of the adhesive. In one variant, the redirecting portion may have a V-shape. In another variant, the redirecting portion may have a U-shape.
The at least one supply opening and the at least one discharge opening may be arranged in a direction of a longitudinal of the fasting portion and/or in radial direction outside of the fastening portion. The at least one supply opening and the at least one discharge opening may be included in at least one plane. This plane may extend perpendicular to a longitudinal axis of the fastening portion. The at least one plane may be displaced relative to the redirecting portion. The at least one plane and the redirecting portion may be displaced by a particular distance in a direction of the longitudinal axis of the fastening portion. The at least one plane may be spaced apart from the fastening portion. Thus, the at least one plane may extend in a direction of the longitudinal axis of the fastening portion outside of the fastening portion.
The at least one supply opening and the at least one discharge opening may be separated from the fastening portion by a step-like portion. The step-like portion may define an abutment surface for an abutment of the object to be fastened to the fastening portion of the connecting member. The fastening portion may have a cylindrical shape. The fastening portion may be configured to be connected to an object having a rod-, duct- or a tube-like shape. The fastening portion may have an opening extending in axial direction to the fasting portion. Therefore, the fastening portion may be hollow.
The connecting member may comprise a vent hole. The vent hole may be connected to a vent channel extending at least partly through the fastening portion. The vent hole may be arranged in the step-like portion separating the at least one discharge opening and the at least one supply opening from the fastening portion. The vent hole may have an angular offset to the at least one supply opening and/or the at least one discharge opening, which may be arranged at the step-like portion as well. The vent hole may be connected to an inner space defined by the hollow fastening portion.
The connecting member may comprise an attachment portion for attachment of an object to be connected to the other object by means of the connecting member. The attachment portion may comprise an attachment opening for receiving at least a portion of the other object. The attachment portion may extend in an angled manner with respect to the fastening portion. The attachment portion may be connected to the step-like portion separating the at least one supply opening and the at least one discharge opening from the fastening portion.
The fastening area may be formed by the inner circumferential surface or the outer circumferential surface of the fastening portion. The at least one supply opening and the at least one discharge opening may be formed at an outer circumferential surface of the fastening portion. The at least one supply opening and the at least one discharge opening may be included in one plane or along one straight line. The plane or line may extend perpendicularly to a longitudinal axis of the fastening portion. The at least one supply opening and the at least one discharge opening may be arranged in radial direction of the fastening portion outside of the fastening area.
According to a second aspect of the present disclosure, a method for connecting the connecting member as described above with an object by means of an adhesive is provided. The method comprises the steps of arranging the fastening portion of the connecting member at the object such that the at least open channel portion is covered by a surface by the object to form a closed channel portion, of supplying the adhesive via the at least one supply opening to the at least one channel of the connecting member, wherein the adhesive flows through the first internal channel portion, the closed channel portion and the second internal channel portion to the at least one discharge opening, wherein the adhesive in the open channel portion comes into contact with both, the connecting member and the object, to establish an adhering connecting between the connecting member and the object, and of stopping supply of the adhesive when the adhesive leaks out of the at least one discharge opening.
BRIEF DESCRIPTION OF THE DRAWINGS
Further details, advantages and aspects of the present invention will become apparent from the following embodiments taken in conjunction with the drawings, wherein:
FIG. 1 shows a front view of a connecting member according to a first embodiment;
FIG. 2 shows a back view of the connecting member of FIG. 1;
FIG. 3 shows a cross-sectional view along the cutting line III-III in FIG. 2;
FIG. 4 shows a side view of the connecting member of the FIGS. 1 to 3;
FIG. 5 shows a partially cutted view of a connecting member according to a second embodiment;
FIG. 6 shows a partially cutted view of the connecting member of FIG. 5 fastened to an object;
FIG. 7 shows a schematic perspective view of a connecting member according to a third embodiment; and
FIGS. 8 to 11 show different schematic perspective views of a connecting member according to a fourth embodiment.
DETAILED DESCRIPTION
In the following description, exemplary embodiments of a connecting member and a method for connecting the connecting member to at least one object by means of an adhesive will be explained with reference to the attached drawings. The same or similar reference numerals will be used to denote the same or similar structural features.
FIG. 1 shows a front view of a connecting member 10 according to a first embodiment. The connecting member 10 comprises a fastening portion 12 to be fastened to a first object (not shown) by means of an adhesive. The connecting member 10 further comprises an attachment portion 14 for attachment of a second object (not shown) to be connected to the first object by means of the connecting member 10. The fastening portion 12 and the attachment portion 14 are in the present embodiment interconnected by a step-like portion 16. In other embodiments, the step-like portion 16 may be omitted or replaced by one or more other interconnecting portions.
The fastening portion 12 has a cylindrical shape with an essentially circular cross-section. The fastening portion 12 comprises a fastening area FA, which is configured to come into contact with the object to be fastened. The fastening area FA is formed by the outer circumferential surface 20 of the fastening portion 12. An open channel portion 18 representing a portion of a channel for directing the flow of adhesive extends on the outer circumferential surface 20 of the fastening porting 12. The open channel portion 18 comprises a first helical portion 22 and a second helical portion 24 (similar to a double thread). The first helical portion 22 and the second helical portion 24 are connected by a redirecting portion 26. The redirecting portion has a U-shape. The first helical portion 22 leads the flow of adhesive coming from the step-like portion 16 to the redirecting portion 26. The second helical portion 24 directs the flow of adhesive from the redirecting portion 26 in the direction of the step-like portion 16.
The attachment portion 14 comprises an attachment opening 28. The attachment opening 28 is configured to receive a portion of the second object (not shown) to be connected by the connecting member 10 to the first object (not shown). It will be appreciated that the attachment portion 14 could have any desired configuration for connecting the second object thereto. As an example, the attachment portion 14 could alternatively be configured as a threaded rod or threaded bore to receive a corresponding counter-thread of the second object.
FIG. 2 shows a backside view of the connecting member 10. As explained above, the connecting member 10 comprises the fastening porting 12, the attachment portion 14 and the step-like portion 16 connecting the fastening porting 12 and the attachment portion 14. The step-like portion 16 comprises a vent hole 30 that is connected to the fastening portion 12 in order to allow air to be exhausted from inside the object, to which the fastening portion 12 is fastened, during the fastening process (i.e., during the insertion of the fastening portion 12 into the object).
FIG. 3 shows a sectional view representing a cut along the cutline III-III in FIG. 2. As apparent from FIG. 3, the fastening porting 12 comprises an opening 32 extending in a direction of the longitudinal axis L of the fastening portion 12 into the fastening portion 12. Thus, the fastening portion 12 is hollow. The opening 32 of the fastening portion 12 is connected to a vent channel 34 extending between the vent opening 30 and the opening 32 of the fastening portion 12. The vent channel 34 extends from the vent opening 30 at the step-like portion 16 into a body of the connecting member 10. The vent channel 34 connects the opening 32 of the fastening porting 12 to the vent opening 30 to allow air to be exhausted from the inside of the object when fastening the fastening portion 12 to an object (not shown), in particular when inserting the fastening portion 12 into an object. The step-like portion 16 comprises an abutment surface 36 for an abutment of the object to which the fastening porting 12 is fastened. The abutment surface 36 extends perpendicular to the longitudinal axis of the fastening porting 12.
FIG. 4 shows a side view of the connecting member 10. In FIG. 4, the fastening portion 12, the attachment portion 14 and the step-like portion 16 are again shown.
The fastening portion 12 comprises the open channel portion 18 at its outer circumferential surface. The open channel 18 extends groove- or recess-like at the outer circumferential surface 20 of the fastening portion 12. An adhesive may enter the open channel portion 18 via an exit opening 38 of an internal channel portion (not shown), which extends in the body of the connecting member 10. The open channel portion 18 is formed by a winding recess at the outer circumferential surface 20 of the fastening portion 12, which is defined by wall portions 40, 42. The wall portions 40 and 42 define the course of the windings of the helical portions 22, 24 of the open channel portion 18. Each wall portion 40, 42 comprises a surface section 44 of the outer circumferential surface 20. These surface sections 44 represent the top surface of each wall portion 40, 42. The surface sections 44 and the other remaining portions of the outer circumferential surface 20 are configured to come into contact with the object (not shown) to which the fastening portion 12 is to be fastened.
FIG. 5 shows a partially cuffed front view of a connecting member 10 according to a second embodiment. The attachment portion 14 of the connecting member 10 according to the embodiment shown in FIG. 5 is slightly different from the attachment portion shown in the FIGS. 1 to 4. In more detail, the attachment portion 14 according to the embodiment of FIG. 5 comprises two mounting portions 46 and 48, each comprising a mounting opening 50, 52 for mounting an object to the attachment portion 14. The fastening portion 12 and the step-like portion 16 of the embodiment shown in FIG. 5 are substantially identical to the fastening portion and the step-like portion of the first embodiment shown in the FIGS. 1 to 4. Accordingly, the following explanations made regarding the fastening portion 12 and the step-like portion 16 in connection with the embodiment shown in FIGS. 5 and 6 apply to the first embodiment shown in FIGS. 1 to 4 as well.
The connecting member 10 comprises a supply opening 54 for supplying adhesive and a discharge opening 56 for discharging a part of the adhesive. The redirecting portion 26 redirects the flow of adhesive coming from the supply opening 54 in the direction of the discharge opening 56. The supply opening 54 and the discharge opening 56 are arranged in the step-like portion 16. The supply opening 54 and the discharge opening 56 are connected by a channel 58. The channel 58 comprises the open channel portion 18 that forms a portion of the channel 58. The channel 58 further comprises a first internal channel portion 60 and a second internal channel portion 62. The first internal channel portion 60 connects the supply opening 54 to the open channel portion 18. The second internal channel portion 62 connects the open channel portion 18 to the discharge opening 56. The first internal channel portion 60 comprises an exit opening 38. Adhesive coming from the first internal channel portion 60 arrives via the exit opening 38 at the open channel portion 18. The second internal channel portion 62 comprises an entry opening 64 at which the adhesive enters the second internal channel portion 62 to be partly discharged at the discharge opening 56. The first and the second internal channel portions 60 and 62 extend in the body of the connecting member 10. The first and the second internal channel portions 60, 62 comprise a first internal channel section 66, 68 extending in radial direction into the body B of the fastening portion 12. Each of the first and second internal channel portions 60, 62 further comprises a second internal channel section 70, 72 extending between the first internal channel section 66, 68 and the exit opening 38 or the entry opening 64, respectively.
Adhesive is supplied to the channel 58 via the supply opening 54. The adhesive flows through the first internal channel portion 60 and enters the open channel portion 18 via the exit opening 38 of the first internal channel portion 60. The adhesive flows from the exit opening 38 through the first helical portion 22 of the open channel portion 18 to the redirecting portion 26 (see FIGS. 1 and 4) and from the redirecting portion 26 along the second helical portion 24 to the entry opening 64 of the second internal channel portions 62. The adhesive then flows through the second internal channel portion 62. When the adhesive leaks out from the second internal channel portion 62 (i.e., out from the channel 58) via the discharge opening 68, the supply of adhesive can be stopped, since the channel 58 is sufficiently filled with the adhesive.
The redirecting portion 26 is indicated in FIG. 5 by an arrow denoted by the reference numeral 26. The connecting member 10 has an axial extension. The redirecting portion 26 is located on the same side of the supply opening 54 and the discharge opening 56 with respect to the axial extension of the connecting member 10. The supply opening 54 and the discharge opening 56 are included in a plane P that extends perpendicular to the longitudinal axis L of the fastening portion 12. The supply opening 54 and the discharge opening 56 are arranged at the step-like portion 16, which is separate from the fastening portion 12. The supply opening 54 and the discharge opening 56 are arranged outside of the fastening portion 12. Since the supply opening 54 and the discharge opening 56 are provided in the step-like portion, the plane P is spaced apart from the fastening portion 12. The first internal channel sections 66 and 68 of the first internal channel 60 and the second internal channel 62 extend in the step-like portion 16. The same applies partly for the second internal channel sections 70, 72 extending to the open channel portion 18.
FIG. 6 shows a partially cuffed view of the connecting member 10 fastened with its fastening portion 12 to a tube-like object 74. The fastening portion 12 is inserted into the object 74. The end face 76 of the tube shaped object 74 abuts at the abutment surface 36 of the step-like portion 16. The inner circumferential surface 78 of the tube-shaped object 74 abuts at the outer circumferential surface 20 and the surface sections 44 of the outer circumferential surface 20. The open channel portion 18 is covered by the inner circumferential surface 78 of the object 74 to form a closed channel portion 80. Adhesive flowing through the closed channel portion 80 comes into contact with the connecting member 10 and with the object 74, to establish an adhering connecting between the connecting member 10 and the object 74.
Since the supply opening 54 and the discharge opening 56 are arranged outside of the fastening portion 12 and outside of the fastening area FA, adhesive can be supplied via the supplied opening 54 and discharged via the discharged opening 56 without any interference with the object 74. The adhesive is supplied via the supply opening 54 and flows through the first internal channel portion 60. The adhesive continues to flow through the first helical portion 22 of the open channel portion 18, which is now the closed channel portion 80, to the redirecting portion 26 arranged at the axial end of the fastening portion 12. The U-shaped redirecting portion 26 redirects the flow of adhesive coming from the supply opening 54 and the first helical portion 23 into the second helical portion 24. The adhesive then flows through the second helical portion 24 of the open channel portion 18 (i.e., the closed channel portion 80) to the second internal channel portion 62 and is discharged via the discharge opening 56. When the adhesive arrives at the discharge opening 56 and leaks out at the discharge opening 56, the supply of the adhesive can be stopped.
FIG. 7 shows a schematic perspective view of a connecting member 10 according to a third embodiment. In FIG. 7 only the fastening portion 12 and the step-like portion 16 of the connecting member 10 according to the third embodiment are shown. Not shown in the schematic drawing of FIG. 7 is the attachment portion 14. The attachment portion 14 of the connecting member 10 according to the third embodiment may have the shape of the attachment portion of one of the first or the second embodiment (see FIGS. 1 to 6). The above explanations regarding the attachment portion 14 and regarding further details of the fastening portion 12 and the step-like portion 16 apply for the third embodiment of the connecting member 10 shown in FIG. 7 as well.
The connecting member 10 comprises the supply opening 54 for supplying adhesive and the discharge opening 56 for discharging a part of the adhesive. The supply opening 54 and the discharge opening 56 are arranged in the step-like portion 16. The supply opening 54 and the discharge opening 56 are arranged outside of the fastening portion 12.
The fastening portion 12 has a cylindrical shape with an essentially circular cross-section. The fastening portion 12 comprises a fastening area FA, which is configured to come into contact with the object (not shown) to be fastened. The fastening area FA is formed by the outer circumferential surface 20 of the fastening portion 12. The open channel portion 18 represents a portion of a channel for directing the flow of adhesive and extends on the outer circumferential surface 20 of the fastening porting 12. The supply opening 54 and the discharge opening 56 are connected by the channel 58. The channel 58 comprises the open channel portion 18 as well as a first internal channel portion 60 and a second internal channel portion 62. The first internal channel portion 60 connects the supply opening 54 to the open channel portion 18. The second internal channel portion 62 connects the open channel portion 18 to the discharge opening 56.
The open channel portion 18 comprises a meandering portion 82. The meandering portion 82 includes straight sections 84 which extend substantially parallel to each other and substantially parallel to the longitudinal axis L of the fastening portion 18. The open channel portion 18 further includes curved sections 86 and 88 which connect two subsequent or neighbouring straight sections 84 with each other. Each of the curved sections 86 and 88 forms a redirecting portion. The curved sections 86 are arranged at or close to the axial end of the fastening portion 12 connected to the step-like portion 16. The curved sections 88 are arranged at or close to the other or free axial end of the fastening portion 12. The curved sections 86 and 88 are arranged at opposite axial ends of the fastening portion 12. The straight sections 84 extend between the two axial ends of the fastening portion 12. The curved sections 86 and 88 have a U-shape and direct the flow of adhesive from one straight section 84 into the next straight section 84. The first internal channel portion 60 is connected to a straight section 84. The second internal channel portion 62 is connected to a further and different straight section 84. As indicated by the arrows AS and AD the direction of the flow of adhesive in two neighbouring straight sections 84 is opposite, since the curved sections 86 and 88 redirect the flow of adhesive.
The supply opening 54 and the discharge opening 56 are arranged outside of the fastening portion 12 and outside of the fastening area FA, so that adhesive can be supplied via the supplied opening 54 and discharged via the discharged opening 56 without any interference with the object. The adhesive is supplied via the supply opening 54 and flows through the first internal channel portion 60. The adhesive continues to flow through the meandering portion 82 of the open channel portion 18 with its straight sections 84 and its curved sections 86, 88. The adhesive then flows to the second internal channel portion 62 and is discharged via the discharge opening 56. When the adhesive arrives at the discharge opening 56 and leaks out at discharge opening 56, the supply of the adhesive can be stopped.
FIGS. 8 to 11 show schematic perspective views of a connecting member 10 according to a fourth embodiment. In FIGS. 8 to 11 only the fastening portion 12 of the connecting member 10 according to the fourth embodiment is shown. Not shown in the schematic drawings of FIGS. 8 to 11 is the attachment portion 14. The attachment portion 14 of the connecting member 10 according to the fourth embodiment may have the shape of the attachment portion of one of the first or the second embodiment (see FIGS. 1 to 6). The explanations regarding the attachment portion 14 and regarding further details of the fastening portion 12 as made with respect to the first and the second embodiments apply for the fourth embodiment of the connecting member 10 shown in FIGS. 8 to 11 as well.
The fastening portion 12 shown in FIG. 8 has a tube shape. The tube-shaped fastening portion 12 has an inner circumferential surface 90, an opening 92 for inserting the object (not shown) to be fastened to the fastening portion 12 and an outer circumferential surface 94. The fastening portion 12 comprises a fastening area FA, which is configured to come into contact with the object to be fastened. The fastening area FA is formed by the inner circumferential surface 90 of the fastening portion 12. On the inner circumferential surface 90 of the fastening portion 12 extends the open channel portion 18 representing a portion of a channel 58 for directing the flow of adhesive. The supply opening 54 and the discharge opening 56 are connected by the channel 58. The channel 58 comprises a first internal channel portion 60 and a second internal channel portion 62. The first internal channel portion 60 connects the supply opening 54 to the open channel portion 18. The second internal channel portion 62 connects the open channel portion to the discharge opening 56. The supply opening 54 and the discharge opening 56 are formed on an outer circumferential surface 94 of the fastening portion 12 and, thus, outside of the fastening area FA.
FIG. 9 shows a further schematic perspective view of the fastening portion 12 of the connecting member 10 according to the fourth embodiment. The open channel portion 18 extends on the inner circumferential surface 90 and connects the first internal channel portion 60 and the second internal channel portion 62. The open channel portion 18 comprises a first helical portion 22 and a second helical portion 24. The first helical portion 22 and the second helical portion 24 are connected by a redirecting portion 26. The redirecting portion 26 has a U-shape. The first helical portion 22 leads the flow of adhesive coming from the first internal channel portion 60 to the redirecting portion. The second helical portion 24 directs the flow of adhesive from the redirecting portion 26 in the direction of the second internal channel portion 62.
The open channel portion 18 is formed by a winding recess at the inner circumferential surface 90 of the fastening portion 12. The winding recess is defined by wall portions 40, 42. The wall portions 40 and 42 define the course of the windings of the helical portions 22, 24 of the open channel portion 18 at the inner circumferential surface 90. Each wall portion 40, 42 comprises a surface section 44 of the inner circumferential surface 90. These surface sections 44 represent the top surface of each wall portion 40, 42. The surface sections 44 and the other remaining portions of the inner circumferential surface are configured to come into contact with the object (not shown) to which the fastening portion 12 is to be fastened. The wall portions 40, 42 extend at least partly radially inwardly.
FIG. 10 shows a further schematic perspective view of the fastening portion 12 of the connecting member 10. FIG. 10 illustrates the open channel portion 18 extending on the inner circumferential surface 90 of the tube-shaped fastening portion 12.
FIG. 11 shows a further schematic perspective view of the fastening portion 12, in which the fastening portion 12 is transparent to highlight the course of the channel 58. The channel 58 connects the supply opening 54 and the discharge opening 56. The first internal channel portion 60 and the second internal channel portion 62 have a substantially cylindrical shape and extend substantially in radial direction through the tube-shaped fastening portion 12 to the inner circumferential surface 90. The first internal channel portion 60 and the second internal channel portion 62 are connected by the open channel portion 18. The open channel portion 18 comprises the first helical portion 22 and the second helical portion 24, which are connected by the redirecting portion 26. The redirecting portion 26 has a U-shape for redirecting the flow of adhesive. The windings of the open channel portion 18 are formed by wall portions 40, 42.
An object (not shown) to be fastened to the fastening portion 12 is inserted into the opening 92 of the tube-shaped fastening portion 12. The outer circumferential surface of the object, which may have a rod or tube shape, abuts at the inner circumferential surface 90 and the surface sections 44 of the inner circumferential surface 90. The open channel portion 18 is covered by the outer circumferential surface of the object to form a closed channel portion. Adhesive flowing through the closed channel portion comes into contact with the connecting member 10 and with the object, to establish an adhering connection between the connecting member 10 and the object.
Since the supply opening 54 and the discharge opening 56 are arranged in radial direction outside of the fastening area FA at the outer circumferential surface 94 of the fastening portion 12, the adhesive can be supplied via the supply opening 54 and discharged via the discharge opening 56 without any interference with the object to be fastened. The adhesive is supplied via the supply opening 54 and flows through the first internal channel portion 60. The adhesive continues to flow through the first helical portion 22 of the open channel portion 18, which is now the closed channel portion, to the redirecting portion 26 arranged at the axial end of the fastening portion 12. The U-shaped redirecting portion 26 redirects the flow of adhesive coming from the supply opening 54 and the first helical portion 22 into the second helical portion 24. The adhesive then flows through the second helical portion 24 of the open channel portion 18 to the second internal channel portion 62 and is discharged via the discharge opening 56. When the adhesive arrives the discharge opening 56 and leaks out at the discharge opening 56, the supply of adhesive can be stopped.
The following explanations apply to all embodiments shown in the drawings and described above. Since the discharge opening 56 is arranged outside of the fastening portion 12 and/or outside of the fastening area FA of the fastening portion 12, it can be determined that enough adhesive has been supplied, when adhesive leaks out of the discharge opening 56. The quantity of adhesive is essential to achieve a reliable adhering connection between the fastening portion 12 and the object 74. In other words, when adhesive leaks out of the discharge opening 56, the closed channel portion 80 is sufficiently filled with adhesive to establish a reliable adhering connection between the fastening portion 12 and the object 74. Thus, with the connecting member 10, it can be ensured that enough adhesive has been supplied to securely fasten the fastening portion 12 to the object 74. By means of the open channel portion 18 forming together with the object 74 the closed channel portion 80, the adhesive is directed exactly in the area between the connecting member 10 and the inner circumferential surface 78 of the object 74 or between the connecting member 10 and the outer circumferential surface of the object. By doing so, a high quality of the adhering connection between the object 74 and the connecting member 10 can be ensured. Since the adhesive flows along the outer circumferential surface 20 of the fastening portion 12, the fastening portion 12 of the first to third embodiments can be made hollow. Thus, the connecting member 10 is light.
Moreover, due to the hollow fastening portion 12, the vent opening 30 can be easily be provided by establishing a connection between the opening 32 of the fastening portion 12 and the outside of the connecting member 10. The vent opening 30 allows air to be exhausted from inside the object 74, when the fastening portion 12 is inserted in the object 74, to facilitate the insertion of the fastening portion 12 into the object 74 and the entire connection process between the object 74 and the connecting member 10.
The features described in relation to the exemplary embodiments shown in the drawings can be readily combined to create further embodiments. It is apparent, therefore, that the present disclosure may be varied in many ways. Such variations are not regarded as a departure from the scope of the invention as defined by the claims appended hereto.
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16560533
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stryker european holdings i, llc
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USA
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B2
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Utility Patent Grant (with pre-grant publication) issued on or after January 2, 2001.
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Open
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Apr 20th, 2022 02:51PM
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Apr 20th, 2022 02:51PM
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Stryker
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Health Care
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Health Care Equipment & Services
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nyse:syk
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Stryker
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Apr 19th, 2022 12:00AM
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Jul 31st, 2020 12:00AM
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https://www.uspto.gov?id=US11304861-20220419
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Patient transport apparatus with movable end handle system
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Patient transport apparatus including a patient litter and a litter support apparatus for supporting the patient litter from a ground surface. The litter support apparatus includes a litter support frame including a pair of litter supports spaced a distance apart to define a loading gap for receiving the patient litter therethrough. A handle system is coupled to the pair of litter supports and includes a handle assembly that is positionable between a closed configuration and an open configuration. The handle assembly extends across the loading gap defined between the pair of litter supports in the closed configuration and is positioned away from the loading gap in the open configuration.
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11304861
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1. A patient transport apparatus comprising:
a patient litter to support a patient; and
a litter support apparatus for supporting said patient litter above a ground surface, said litter support apparatus comprising a litter support frame including:
a pair of litter supports including a first litter support spaced a distance from a second litter support to define a loading gap for receiving said patient litter therethrough; and
a handle system coupled to said pair of litter supports, said handle system including:
a locking member coupled to one of said pair of litter supports, and
a handle assembly coupled to the other of said pair of litter supports and being positionable between a closed configuration and an open configuration, said handle assembly positioned away from the loading gap in the open configuration, and extending across the loading gap defined between said pair of litter supports into releasable engagement with said locking member in the closed configuration.
2. The patient transport apparatus of claim 1, wherein said handle system includes a first support member coupled to said first litter support and a second support member coupled to said second litter support, said handle assembly including:
an upper crossbar extending between said first and second support members,
a lower crossbar spaced a vertical distance from said upper crossbar; and
wherein said upper crossbar and said lower crossbar are movable between the closed configuration and the open configuration.
3. The patient transport apparatus of claim 2, wherein said upper crossbar is pivotably coupled to said first support member and rotatable about a first pivot axis.
4. The patient transport apparatus of claim 3, wherein said locking member is further defined as a first locking member and wherein said second support member includes said first locking member, said first locking member being configured to engage said upper crossbar with said upper crossbar in the closed configuration.
5. The patient transport apparatus of claim 4, wherein said lower crossbar is pivotably coupled to said second support member and rotatable about a second pivot axis.
6. The patient transport apparatus of claim 5, wherein said first support member includes a second locking member configured to engage said lower crossbar with said lower crossbar in the closed configuration.
7. The patient transport apparatus of claim 2, wherein said upper crossbar and said lower crossbar are orientated vertically in the open configuration.
8. The patient transport apparatus of claim 1, wherein said handle assembly includes a first collapsible cage assembly coupled to said first litter support and a second collapsible cage assembly coupled to said second litter support.
9. The patient transport apparatus of claim 8, wherein said first collapsible cage assembly contacts said second collapsible cage assembly in the closed configuration; and
wherein said first collapsible cage assembly is spaced apart from said second collapsible cage assembly in the open configuration such that the loading gap is defined therebetween.
10. The patient transport apparatus of claim 8, wherein said first collapsible cage assembly and said second collapsible cage assembly each include a plurality of links pivotably coupled together and configured to form a substantially rectangular shape in the closed configuration and a substantially planar shape in the open configuration.
11. The patient transport apparatus of claim 10, wherein said first collapsible cage assembly is pivotably coupled to said first litter support and rotatable about a first vertical pivot axis; and
wherein said second collapsible cage assembly is pivotably coupled to said second litter support and rotatable about a second vertical pivot axis.
12. The patient transport apparatus of claim 1, wherein said handle assembly includes a wagon handle assembly pivotably coupled to said first litter support and extending between said first litter support and said second litter support in the closed configuration.
13. The patient transport apparatus of claim 12, wherein said handle system includes a first support member coupled to said first litter support and a second support member coupled to said second litter support, and
said wagon handle assembly includes a pivot support coupled to said first support member, said pivot support configured to allow rotation of said wagon handle assembly about a first pivot axis and a second pivot axis.
14. The patient transport apparatus of claim 13, wherein said wagon handle assembly is positionable to a stowed configuration along a side of said litter support apparatus.
15. The patient transport apparatus of claim 13, wherein said wagon handle assembly includes
an upper support bar extending between said first and second support members;
a lower support bar spaced a vertical distance from said upper support bar; and
a secondary handle assembly extending between said upper support bar and said lower support bar.
16. The patient transport apparatus of claim 15, wherein said secondary handle assembly is rotatably coupled to said upper support bar and configured to rotate about said upper support bar.
17. The patient transport apparatus of claim 15, wherein said upper support bar extends between a first end and a second end, the first end being coupled to said pivot support.
18. The patient transport apparatus of claim 17, wherein said wagon handle assembly includes a latch mechanism configured to releasably couple said wagon handle assembly to said second support member with said wagon handle assembly in the closed configuration.
19. The patient transport apparatus of claim 1, wherein said handle assembly includes:
a first upper handle rotatably coupled to said first litter support and configured to rotate about a first rotational axis; and
a second upper handle rotatably coupled to said second litter support and configured to rotate about a second rotational axis parallel to the first rotational axis.
20. The patient transport apparatus of claim 19, wherein said first and second upper handles are configured to be orientated substantially horizontally in the closed configuration; and
wherein said handle assembly includes a first lower handle and a second lower handle.
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20
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CROSS-REFERENCE TO RELATED APPLICATION
The subject patent application claims priority to and all the benefits of U.S. Provisional Patent Application No. 62/882,089 filed on Aug. 2, 2019, the disclosure of which is hereby incorporated by reference in its entirety.
BACKGROUND
Patient transport apparatuses, such as hospital beds, stretchers, cots, tables, wheelchairs, and chairs facilitate care and transportation of patients. Conventional patient transport apparatuses comprise a base, lift device, and a litter comprising a patient support surface upon which the patient is supported. The litter may be removable from the base to facilitate loading a patient onto the litter closer to the ground surface. Once the patient is loaded onto the litter near the ground surface, the litter is raised and disposed on the base to then transport the patient.
Traditionally, a patient transport apparatus includes pushing and/or lifting handles located at a foot end of the patient transport apparatus to enable caregivers to more easily move the patient transport apparatus. However, these pushing and/or lifting handles obstruct the foot end of the patient transport apparatus, which may cause difficulty when removing the litter from the base and/or when placing the litter onto the base.
Therefore, a patient transport apparatus that addresses one or more of the aforementioned challenges is desired.
BRIEF DESCRIPTION OF THE DRAWINGS
Advantages of the present disclosure will be readily appreciated as the same becomes better understood by reference to the following detailed description when considered in connection with the accompanying drawings.
FIG. 1 is a perspective view of a patient transport apparatus including a movable end handle system in a closed configuration.
FIG. 2 is another perspective view of the patient transport apparatus of FIG. 1 with the end handle system in an open configuration.
FIG. 3 is a perspective view of a portion of a patient transport apparatus including an end handle system in a closed configuration.
FIG. 4 is a perspective view of the patient transport apparatus of FIG. 3 with the end handle system in an open configuration.
FIGS. 5A and 5B are perspective views of a patient transport apparatus including different versions of a movable end handle system.
FIG. 6 is a side view of the patient transport apparatus shown in FIG. 5A.
FIGS. 7A-7F are a sequence of images illustrating movement of the end handle system of FIGS. 5A and 6 from the closed configuration to a stowed configuration.
FIG. 8A is a perspective view of a latch mechanism that may be used with the end handle system shown in FIGS. 5A and 5B, with the latch mechanism in a locked position.
FIG. 8B is a perspective view of the latch mechanism in an unlocked position.
FIG. 9 is a partial perspective view of another end handle system.
FIG. 10A is a perspective view of a portion of the end handle system shown in FIG. 9 in the closed configuration.
FIG. 10B is a perspective view of a portion of the end handle system shown in FIG. 9 in the open configuration.
FIG. 11 is a perspective view of a handle that may be used with the end handle system shown in FIG. 9 in the closed configuration.
FIG. 12 is a perspective view of the handle that may be used with the end handle system shown in FIG. 9 in the open configuration.
DETAILED DESCRIPTION
Referring to FIGS. 1-6, a patient transport apparatus 10 is shown for supporting a patient in a health care setting according to embodiments of the present disclosure. As will be appreciated from the subsequent description below, while the illustrated embodiments of the patient transport apparatus 10 described herein are configured as cots for transporting patients, the patient transport apparatus 10 may comprise a hospital bed, a stretcher, a table, a wheelchair, a chair, or a similar apparatus utilized in the care of a patient.
The patient transport apparatus 10 comprises a patient litter 12 and a litter support apparatus 14 for supporting the litter 12 above a ground surface. The litter 12 and the litter support apparatus 14 each have a head end 16 and a foot end 18 corresponding to designated placement of the patient's head and feet on the patient transport apparatus 10. The litter 12 is configured to be removably supported by the litter support apparatus 14 and may be separated from the litter support apparatus 14 to facilitate loading the patient onto the litter 12. For example, in operation, the litter 12 is removed from the litter support apparatus 14 by one or more caregivers and maybe placed on the ground surface next to a patient. The patient is then placed onto the litter 12. The litter 12 with the patient supported thereon are then loaded onto the litter support apparatus 14. The caregiver(s) may then load the litter support apparatus 14 with the patient into an ambulance.
As is described in greater detail below, the litter support apparatus 14 is configured to removably receive and support the litter 12 in certain situations. Put differently, in the illustrated embodiments, the litter 12 is configured for releasable attachment to the litter support apparatus 14. As will be appreciated from the subsequent description below, the litter 12 may be considered to be a patient support apparatus both when it is attached to the litter support apparatus 14 and when it has been removed from the litter support apparatus 14.
The litter 12 may comprise a patient support deck 20 that includes several sections, some of which are capable of being articulated relative to others, such as a fowler section 22, a seat section 24, a foot section 26, or any combination thereof. The fowler section 22 and the foot section 26 may pivot relative to the seat section 24, or may articulate relative to the seat section 24 in any manner. For instance, the fowler section 22 and/or the foot section 26 may both pivot and translate relative to the seat section 24 in some configurations. The seat section 24 and/or foot section 26 may also support legs of the patient. The sections may extend in various lengths and may have various configurations. Deck panels 28 are disposed on each of the sections collectively forming or otherwise defining the patient support surface 26. The deck panels 28 may comprise rigid panels with or without padding or any other suitable materials for supporting the patient. A mattress (or sections thereof) may be disposed on or be integral with the litter 12. In such circumstances, the mattress comprises or otherwise defines a secondary patient support surface upon which the patient is supported.
In some embodiments, the litter 12 is configured to serve as a mobile chair to transport patients up and down stairs. Mobile chairs are used to evacuate patients from buildings where patient accessibility is limited, such as buildings having more than one floor.
In some embodiments, the litter 12 may include one or more support frames 30 that are coupled to the seat section 24 and/or foot section 26. The litter 12 may further include one or more wheels 32 rotatably coupled to the support frame 30 which are configured to be disposed in contact with the ground surface. In the illustrated embodiments, the wheels 32 are freely rotatable. In alternative embodiments, the wheels 32 may be powered drive wheels. The support frame 30 may also comprise tracks, such as powered drive tracks. One example of a litter 12 is shown in U.S. Patent Application Publication No. 2018/0028383, hereby incorporated herein by reference.
The litter support apparatus 14 comprises a base frame 34 and a litter support frame 36. The litter support frame 36 is spaced above the base frame 34. A lift device 38 may be coupled to the base frame 34 and the litter support frame 36 to raise and lower the litter support frame 36 to minimum and maximum heights of the patient transport apparatus 10, and intermediate positions therebetween, when the litter 12 is supported by the litter support apparatus 14. The lift device 38 includes one or more lift arms 40 coupling the litter support frame 36 to the base frame 34. The lift device 38 includes one or more lift actuators 42 that are coupled to at least one of the base frame 34 and the litter support frame 36 to raise and lower the litter support frame 36 and litter 12 relative to the ground surface and the base frame 34. The lift device 38 may be configured to operate in the same manner or a similar manner as the lift mechanisms shown in U.S. Pat. Nos. 7,398,571, 9,486,373, 9,510,981, and/or U.S. Patent Application Publication No. 2018/0028383, hereby incorporated herein by reference.
Wheels 44 are coupled to the base frame 34 to facilitate transport over ground surfaces. The wheels 44 are arranged in each of four quadrants of the litter support apparatus 14 adjacent to corners of the base frame 34. In the illustrated embodiments, the wheels 44 are caster wheels, which are able to rotate and swivel relative to the base frame 34 during transport. Each of the wheels 44 forms part of a caster assembly 46. Each caster assembly 46 is mounted to the base frame 34. It should be understood that various configurations of the caster assemblies 46 are contemplated. In addition, in some configurations, the wheels 44 are not caster wheels and may be non-steerable, steerable, non-powered, powered, or combinations thereof. Additional wheels 44 are also contemplated. For example, the patient transport apparatus 10 may comprise four non-powered, non-steerable wheels, along with one or more powered wheels. In some cases, the patient transport apparatus 10 may not include any wheels. In other configurations, one or more auxiliary wheels (powered or non-powered), which are movable between stowed positions and deployed positions, may be coupled to the base frame 34. A fifth wheel may also be arranged substantially in a center of the base. Other configurations are contemplated.
The litter support frame 36 is coupled to the base frame 34 and configured to support the litter 12 above the base frame 34. The litter 12 is removably coupled to the litter support frame 36. The litter support frame 36 includes a pair of litter supports 48, 50 that extend parallel to a longitudinal axis 52 between the foot end 18 and the head end 16 of the patient transport apparatus 10. The pair of litter supports 48, 50 include a first litter support 48 that is spaced a distance from a second litter support 50 to define a loading gap 54 between the first litter support 48 and the second litter support 50. The loading gap 54 is sized and shaped for receiving the litter 12 through the loading gap 54 to facilitate the litter 12 being loaded onto the litter support frame 36 by a caregiver. The litter support frame 36 may also include loading wheels 56 extending from the pair of litter supports 48, 50 proximate the head end 16 to facilitate loading and unloading of the patient transport apparatus 10 into/from a vehicle. For example, the loading wheels 56 may be positioned and configured to facilitate loading and unloading the patient transport apparatus 10 into/from an ambulance.
The litter support apparatus 14 also includes a handle system 58 positioned at the foot end 18 of the patient transport apparatus 10 to facilitate enabling a caregiver to move the patient transport apparatus 10 along the ground surface. The handle system 58 is coupled to the pair of litter supports 48, 50 at the foot end 18 of the patient transport apparatus 10. The handle system 58 includes a first support member 60 that is coupled to the first litter support 48, a second support member 62 that is coupled to the second litter support 50, and a movable handle assembly 64 that extends between the first and second support members 60, 62 and across the loading gap 54. The handle assembly 64 is positionable between a closed position/configuration 66 (shown in FIGS. 1, 3, 5, 6, 7A, and 10A) and an open position/configuration 68 (shown in FIGS. 2, 4, 7C and 10B). The handle assembly 64 is configured to extend across the loading gap 54 defined between the pair of litter supports 48, 50 in the closed configuration 66, and to be positioned away from the loading gap 54 in the open configuration 68. With the handle assembly 64 in the closed configuration 66, a caregiver may use the handle assembly 64 to facilitate pushing and/or pulling the patient transport apparatus 10 along the ground surface to transport the patient. With the handle assembly 64 in the open configuration 68 (see e.g., FIG. 2), the caregiver may more easily access the litter 12 through the loading gap 54 to remove the litter 12 from the litter support apparatus 14, or to more easily load the litter 12 onto the litter support apparatus 14 by moving the litter 12 through the loading gap 54 and onto the litter support apparatus 14.
Referring to FIGS. 1 and 2, in some embodiments, the handle assembly 64 includes an upper crossbar 70 that extends between the first support member 60 and the second support member 62. The upper crossbar 70 is pivotably coupled to the first support member 60 at one end and is configured to rotate about a first pivot axis 72 (shown in FIG. 2) that is orientated substantially parallel to the longitudinal axis 52. A pivot joint is provided between the upper crossbar 70 and the first support member 60 to facilitate this movement. In this manner, the upper crossbar 70 may be moved to the closed configuration 66 in which the upper crossbar 70 extends between the first support member 60 and the second support member 62 and across the loading gap 54, and may be moved to the open configuration 68 in which the upper crossbar 70 extends substantially upright, such as substantially parallel to a vertical axis 74. The upper crossbar 70 may be moved to any position that opens the loading gap 54. In some versions, the pivot joint between the upper crossbar 70 and the first support member 60 prohibits the upper crossbar 70 from falling under the force of gravity, e.g., the pivot joint provides suitable friction, position holding features, or the like to hold the upper crossbar 70 at the position in which the upper crossbar 70 was placed by the user. In other versions, the upper crossbar 70 is freely pivotable and falls under the force of gravity.
The second support member 62 may also include a first locking member 76 that is configured to engage a free end of the upper crossbar 70 in the closed configuration 66 to facilitate retaining the upper crossbar 70 in the closed configuration 66. The first locking member 76 may comprise a first retainer bracket 77 that is generally C-shaped to define an opening to receive the upper crossbar 70, which may have a generally circular cross-section and be sized to fit into the opening. The retainer bracket 77 may be disposed on the second support member 62 such that the upper crossbar 70 can be vertically lifted without slipping from the opening, e.g., an upper portion of the first retainer bracket 77 may depend downward slightly to retain the upper crossbar 70 in the opening during lifting. Other forms of locking members are also contemplated, e.g., detent locks, latch/catch arrangements, and the like.
The handle assembly 64 may also include a lower crossbar 78 that extends between the first support member 60 and the second support member 62. The lower crossbar 78 is spaced a vertical distance from the upper crossbar 70. The upper crossbar 70 and the lower crossbar 78 are each movable between the closed configuration 66 and the open configuration 68. The lower crossbar 78 is pivotably coupled to the second support member 62 at one end and is configured to rotate about a second pivot axis 80 that is orientated substantially parallel to the longitudinal axis 52. A pivot joint is provided between the lower crossbar 78 and the second support member 62 to facilitate this movement. In the closed configuration 66, the lower crossbar 78 extends between the first support member 60 and the second support member 62 across the loading gap 54. In the open configuration 68, the lower crossbar 78 is rotated to an upright position, such as substantially parallel to the vertical axis 74, or to any other position that opens the loading gap 54. In some versions, the pivot joint between the lower crossbar 78 and the second support member 62 prohibits the lower crossbar 78 from falling under the force of gravity, e.g., the pivot joint provides suitable friction, position holding features, or the like to hold the lower crossbar 78 at the position in which the lower crossbar 78 was placed by the user. In other versions, the lower crossbar 78 is freely pivotable and falls under the force of gravity.
The first support member 60 may include a second locking member 82 that is configured to engage a free end of the lower crossbar 78 with the lower crossbar 78 in the closed configuration 66 to facilitate retaining the lower crossbar 78 in the closed configuration 66. The second locking member 82 may also comprise a second retainer bracket 83 that is generally C-shaped to define an opening to receive the lower crossbar 78, which may have a generally circular cross-section and be sized to fit into the opening. The second retainer bracket 83 may be disposed on the first support member 60 such that the lower crossbar 78 can be vertically lifted without slipping from the opening, e.g., the second retainer bracket 83 is orientated so that the opening is directed vertically downward to retain the lower crossbar 78 in the opening during lifting. Other forms of locking members are also contemplated, e.g., detent locks, latch/catch arrangements, and the like.
Referring to FIGS. 3 and 4, in some embodiments, the handle assembly 64 may include a pair of collapsible cage assemblies 84, 86, that are movable between the open configuration 68 and the closed configuration 66. For example, the handle assembly 64 may include a first collapsible cage assembly 84 that is coupled to the first support member 60 and a second collapsible cage assembly 86 that is coupled to the second support member 62. The first collapsible cage assembly 84 may also be pivotably coupled to the first support member 60 and configured to rotate about a first vertical pivot axis 88 (shown in FIG. 4). The second collapsible cage assembly 86 may also be pivotably coupled to the second support member 62 and configured to rotate about a second vertical pivot axis 90. The first collapsible cage assembly 84 and the second collapsible cage assembly 86 each include a plurality of links 92 that are pivotably coupled together. The plurality of links 92 are configured (e.g., in a 4-bar linkage arrangement) to pivot with respect to one another to form a substantially rectangular shape 94 (shown in FIG. 3) and a substantially planar shape 96 (shown in FIG. 4).
In the closed configuration 66, the first collapsible cage assembly 84 and the second collapsible cage assembly 86 each form the substantially rectangular shape 94 such that each collapsible cage assembly 84, 86 extends across a portion of the loading gap 54. For example, as shown in FIG. 3, in the closed configuration 66, the first collapsible cage assembly 84 contacts the second collapsible cage assembly 86 such that the handle assembly 64 extends across the loading gap 54. A locking mechanism may be used to couple the first collapsible cage assembly 84 to the second collapsible cage assembly 86 in the closed configuration 66 to facilitate retaining the collapsible cage assemblies 84, 86 in the closed configuration 66. Any suitable locking mechanism may be employed, including a lock collar, a clamp, fasteners, or the like.
In the open configuration 68, the first collapsible cage assembly 84 and the second collapsible cage assembly 86 each form the substantially planar shape 96 such that the first collapsible cage assembly 84 is spaced apart from the second collapsible cage assembly 86 to defined the loading gap 54 between the first collapsible cage assembly 84 and the second collapsible cage assembly 86.
Referring to FIGS. 5-7F, in some embodiments, the handle assembly 64 comprises a wagon handle assembly 98 that extends between the first support member 60 and the second support member 62. The wagon handle assembly 98 is pivotably coupled to the first support member 60 and is movable between the closed configuration 66 in which the wagon handle assembly 98 extends across the loading gap 54, and the open configuration 68 in which the wagon handle assembly 98 is moved to a stowed position/configuration 100 (shown in FIG. 7F) adjacent to a side of the patient transport apparatus 10.
The wagon handle assembly 98 includes a pivot support 102 that is pivotally coupled to the first support member 60. The pivot support 102 is configured to facilitate rotation of the wagon handle assembly 98 about a first vertical pivot axis 104 and a second pivot axis 106 that is perpendicularly oriented relative to the first vertical axis 104 to enable the wagon handle assembly 98 to pivot away from the foot end 18 of the patient transport apparatus 10 and move to the stowed configuration 100 along the side of the litter support apparatus 14. The pivot support 102 may comprise a U-joint, spherical joint, gimbaled connection, or the like to enable the wagon handle assembly 98 to move in two or more degrees of freedom. In some embodiments, the pivot support 102 includes a first pivot block 103a with first pivot pin 103b that enables the pivot support 102 to pivot about the first vertical pivot axis 104 relative to the first support member 60. The pivot support 102 may further comprise a second pivot block 105a with second pivot pin 105b that enables the pivot support 102 to pivot about the second pivot axis 106. The second pivot block 105a is pivotally coupled to a front panel 61 of the first support member 60 via the second pivot pin 105b as shown in FIG. 5A. The first pivot block 103a is pivotally coupled to the second pivot block 105a via the first pivot pin 103b. As shown in FIG. 5A, the second pivot pin 105b may be orientated such that the second pivot axis 106 is parallel to the longitudinal axis 52. As shown in FIG. 5B, in another version, the second pivot pin 105b may be orientated such that the second pivot axis 106 is substantially perpendicular to the longitudinal axis 52.
The wagon handle assembly 98 also includes a latch mechanism 108 that is configured to releasably couple the wagon handle assembly 98 to the second support member 62 with the wagon handle assembly 98 in the closed configuration 66. The latch mechanism 108 may comprise any suitable latch/catch arrangement in which the latch on the wagon handle assembly 98 engages a catch on the second support member 62, or vice versa. In some embodiments, the latch mechanism 108 may include a toggle latch assembly 109 (shown in FIGS. 9A and 9B). The toggle latch assembly 109 includes a first latch member 111 that is releasably coupled to a second latch member 113 to position the toggle latch assembly 109 in a locked position (shown in FIG. 8A) to maintain the wagon handle assembly 98 in the closed configuration 66 and an unlocked position (shown in FIG. 8B) to enable the wagon handle assembly 98 to be moved to the open configuration 68. The first latch member 111 is coupled to the wagon handle assembly 98 and the second latch member 113 is coupled to the second support member 62.
In some embodiments, the wagon handle assembly 98 includes an upper support bar 110, a lower support bar 112, and a secondary handle assembly 114 that extends vertically between the upper support bar 110 and the lower support bar 112. The upper support bar 110 extends between the first support member 60 and the second support member 62 in the closed configuration 66. The upper support bar 110 is fixed at one end to the first pivot block 103a and is fixed at the other end to a latch block 115 that supports the first latch member 111. The upper support bar 110 extends between a first end 116 and an opposite second end 118 (see FIG. 6). The first end 116 of the upper support bar 110 is coupled to the pivot support 102. The lower support bar 112 is vertically spaced from the upper support bar 110.
The secondary handle assembly 114 includes a pair of handle support members 120 that extend between the upper support bar 112 and the lower support bar 112, and a cross member 122 that extends between the pair of handle support members 120 and is orientated perpendicular to the pair of handle support members 120. The secondary handle assembly 114 is rotatably coupled to the upper support bar 110 and is configured to rotate about the upper support bar 110 (see FIG. 7B). In some embodiments, as shown in FIG. 5B, the secondary handle assembly 114 may be releasably coupled to the lower support bar 112 (e.g., via hooks at the end of the handle support members 120) such that the secondary handle assembly 114 may rotate away from the lower support bar 112 as a caregiver rotates the secondary handle assembly 114 about the upper support bar 110. Accordingly, the secondary handle assembly 114 acts as a secondary handle for maneuvering the patient transport apparatus 10, such as a secondary wagon-type handle.
FIGS. 7A-7F illustrate movement of one version of the wagon handle assembly 98 from the closed configuration 66 (shown in FIG. 7A) to the open and stowed configurations 68, 100 (shown in FIGS. 7C and 7F). Notably, the version shown in FIGS. 7A-7F is the same as that shown in FIGS. 5A and 6, but slightly different from that shown in FIG. 5B. In the version of FIG. 5B, both the upper support bar 110 and the lower support bar 112 are connected in a fixed manner to the first pivot block 103a and the latch block 115 so that both can be moved to the open and stowed configurations upon operating the latch mechanism 108 to release the wagon handle assembly 98 from the second support member 62 and then by pivoting about axes 104, 106. In some versions, the wagon handle assembly 98 only pivots about axis 104 to move between the open and closed configurations. The version shown in FIGS. 5A, 6, and 7A-7F has the lower support bar 112 being releasably connected at its ends to opposing brackets 123, 125 (see FIG. 7B) via locking/securing mechanisms 127 to thereby require additional action to move to the open and stowed configurations. This also allows the secondary handle assembly 114 to rotate about the upper support bar 110. The locking/securing mechanisms 127 may be collars, clamps, hose clamps, fasteners, fittings, latches, catches, tape, hook and loop couplings, or any other suitable device for locking or securing the lower support bar 112 to the brackets 123, 125. In this version, the brackets 123, 125 are shown in the form of tubing that is fixed to the support members 60, 62 respectively, but may comprise any suitable form of brackets.
Referring to FIGS. 7A-7F, initially, the caregiver releases the lower support bar 112 from the brackets 123, 125 via the locking/securing mechanisms 127 and then grasps the lower support bar 112 and pivots the wagon handle assembly 98 outwardly from the litter support frame 36 and about the upper support bar 110, as shown in FIG. 7B (this action may also be performed to use the wagon handle assembly 98 for maneuvering the patient transport apparatus 10). The caregiver then operates the latch mechanism 108 to release the wagon handle assembly 98 from the second support member 62. The caregiver may then rotate the wagon handle assembly 98 away from the foot end 18 of the litter support frame 36 about the second pivot axis 106 using the pivot support 102, as shown in the sequence from FIGS. 7B to 7C (part of the bracket 123 has been broken away in FIG. 7C to better show the pivot blocks 103a, 105a and the pivot pins 103b, 105b). The user then is able to position the wagon handle assembly 98 into the stowed configuration 100 along the side of the litter support frame 36, as shown in FIGS. 7D-7F, by rotating the wagon handle assembly 98 about the first pivot axis 104. This process may be performed in reverse to move the wagon handle assembly 98 from the stowed configuration 100 to the closed configuration 66.
Referring to FIGS. 9-12, in some embodiments, the handle assembly 64 may include a pair of upper handles 124, 126 that are coupled to the support members 60, 62. For example, the handle assembly 64 includes a first upper handle 124 that is rotatably coupled to the first support member 60, and a second upper handle 126 that is rotatably coupled to the second support member 62. The first upper handle 124 extends outwardly from the first support member 60 parallel to the longitudinal axis 52 and is configured to rotate about a first rotational axis 128 (see FIG. 10B) that is orientated parallel to the longitudinal axis 52. The second upper handle 126 extends outwardly from the second support member 62 parallel to the longitudinal axis 52 and is configured to rotate about a second rotational axis 130 that is orientated parallel to the longitudinal axis 52. In the closed configuration 66, shown in FIG. 10A, the first upper handle 124 and the second upper handle 126 are orientated substantially horizontally and extend inwardly towards each other from the support members 60, 62. In the open configuration 68, shown in FIG. 10B, the first upper handle 124 and the second upper handle 126 are orientated substantially vertically such that the loading gap 54 is defined between the first and second upper handles 124, 126. The first upper handle 124 and the second upper handle 126 may be moved to any position suitable to open the loading gap 54. In some embodiments, the first and second upper handles 124, 126 may be configured as telescoping handles that are extendable/retractable with respect the longitudinal axis 52.
The first and second upper handles 124, 126 may be locked to the support members 60, 62 in the open and/or closed configurations in any suitable manner. For example, locking pins 129 may be employed in which throughholes 131 are located in the support members 60, 62 (which are hollow in the version shown) to receive the locking pins 129 (see FIG. 9) and the first and second upper handles 124, 126 have corresponding throughholes 133, 135 (See FIGS. 9 and 10B) that align with the throughholes 131 in the open and closed configurations, respectively, to receive the locking pins 131 to lock the first and second upper handles 124, 126 in the open and closed configurations.
In some embodiments, the handle assembly 64 may also include a first lower handle 132 and a second lower handle 134 that are each positioned vertically below the upper handles 124, 126. In some versions, such as that shown, the first lower handle 132 and the second lower handle 134 are static handles fixed to the litter support frame 36 for lifting or otherwise maneuvering the patient transport apparatus 10. In some versions, the first lower handle 132 is the same shape and configuration as the first upper handle 124 and is rotatably coupled to the first support member 60 and the second lower handle 134 is the same shape and configuration as the second upper handle 126 and is rotatably coupled to the second support member 62 such that the first and second lower handles 132, 134 are movable between the closed configuration 66 and the open configuration 68.
It will be further appreciated that the terms “include,” “includes,” and “including” have the same meaning as the terms “comprise,” “comprises,” and “comprising.” Moreover, it will be appreciated that terms such as “first,” “second,” “third,” and the like are used herein to differentiate certain structural features and components for the non-limiting, illustrative purposes of clarity and consistency.
Several configurations have been discussed in the foregoing description. However, the configurations discussed herein are not intended to be exhaustive or limit the invention to any particular form. The terminology which has been used is intended to be in the nature of words of description rather than of limitation. Many modifications and variations are possible in light of the above teachings and the invention may be practiced otherwise than as specifically described.
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16944764
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stryker corporation
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USA
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B2
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Utility Patent Grant (with pre-grant publication) issued on or after January 2, 2001.
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Open
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Apr 20th, 2022 02:51PM
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Apr 20th, 2022 02:51PM
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Stryker
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Health Care
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Health Care Equipment & Services
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nyse:syk
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Stryker
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Apr 19th, 2022 12:00AM
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Sep 1st, 2017 12:00AM
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https://www.uspto.gov?id=US11304864-20220419
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Patient support systems with a chair configuration and a stowable foot section
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A patient support system comprises a patient support apparatus for patients. The patient support apparatus comprises a base and a litter supported by the base via a lift system. The litter comprises a seat section and a foot section movable relative to the seat section. The lift system comprises lift members. The lift system moves the litter from a first configuration in which the seat and foot sections are generally horizontal relative to a floor surface to a second configuration where the foot section is below the seat section and between the lift members. The patient support apparatus also comprises a mattress assembly integrated with the foot section to move with the foot section between the first and second configurations.
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11304864
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1. A patient support apparatus for supporting a patient above a floor surface, said patient support apparatus comprising:
a litter having a patient support surface for supporting the patient;
a footboard operatively attached to said litter;
a base supporting said litter; and
a lift system comprising first and second lift members, said first and second lift members extending from said base to said litter, with said first lift member being arranged on a first side of said patient support apparatus and said second lift member being arranged on a second side opposite said first side, and coupling said litter to said base, said lift system being configured to move said litter relative to said base,
said litter comprising a seat section and a foot section extending continuously and longitudinally from said seat section to a foot section end, having no rotationally articulating joints disposed between a top of the foot section adjacent to and directly attached to said seat section and said foot section end, with said footboard operatively attached to said foot section end,
wherein said patient support surface comprises a foot section patient support surface defined by said foot section,
wherein said litter has a first configuration in which said seat and foot sections are aligned generally horizontally above the floor surface such that said foot section patient support surface faces away from said base and a second configuration in which said foot section patient support surface faces toward said base with said foot section extending continuously and longitudinally from said seat section to said footboard, said foot section being configured to articulate between said first and second lift members such that said foot section is stowed in the second configuration beneath said seat section, between said seat section and said base, and between said first and second lift members;
wherein said footboard is movably coupled to said foot section with said foot section disposed longitudinally between said seat section and said footboard;
wherein said footboard is movable relative to said foot section between a deployed position and a collapsed position, with said footboard being biased into said deployed position by a biasing device; and
wherein said base comprises an actuation surface, with said footboard configured to abut said actuation surface when said foot section is moved to said second configuration such that an actuation force is applied by said actuation surface on said footboard against a biasing force from said biasing device to move said footboard from said deployed position to said collapsed position.
2. The patient support apparatus of claim 1, wherein said second configuration comprises a chair configuration, said foot section being movable relative to said seat section when moving from said first configuration to said chair configuration.
3. The patient support apparatus of claim 2, wherein said foot section has a first width and said lift members are spaced apart at a second width greater than said first width so that said foot section is movable between said lift members to be stowed beneath said seat section and between said lift members when moving from said first configuration to said chair configuration.
4. The patient support apparatus of claim 1, wherein said base defines a foot end and a head end and said base comprises two foot end support features disposed at said foot end to support said base on the floor surface.
5. The patient support apparatus of claim 4, wherein said base defines an open space between said foot end support features, said open space configured to be open to the floor surface between said foot end support features to receive feet of the patient between said foot end support features when said sections are in said second configuration.
6. The patient support apparatus of claim 5, wherein said foot end support features are spaced apart by a first width and said foot section has a second width narrower than said first width and said foot section is configured to move at least partially within said open space between said foot end support features when said foot section moves from said first configuration to said second configuration.
7. The patient support apparatus of claim 1, wherein said base defines a receiving space to receive at least one of said footboard and said foot section when said sections are in said second configuration such that at least one of said footboard and said foot section nests with said base.
8. The patient support apparatus of claim 1, wherein said lift system comprises
a first actuator coupled to said lift members and said base to pivot said lift members relative to said base and move said litter relative to said base;
a second actuator coupled to said lift members and said seat section to move said lift members relative to said seat section and tilt said seat section and said litter relative to said base;
a third actuator coupled to said foot section to move said foot section relative to said seat section; and
a fourth actuator, wherein said litter comprises a fowler section and said fourth actuator is coupled to said fowler section to move said fowler section relative to said seat section.
9. The patient support apparatus of claim 1, wherein said footboard defines a barrier with respect to said foot section in said deployed position and said footboard is collapsed with respect to said foot section in said collapsed position.
10. The patient support apparatus of claim 1, wherein said footboard being orthogonal to said foot section in said deployed position and said footboard being configured to rotate relative to said foot section and toward said foot section to move to said collapsed position.
11. The patient support apparatus of claim 1, further comprising a mattress disposed on said foot section, wherein said footboard is movable relative to said foot section between a deployed position and a collapsed position, with said footboard configured to trap bedding disposed on said mattress against said mattress when said footboard is in said collapsed position.
12. The patient support apparatus of claim 1, wherein said footboard is configured to be in said collapsed position when said sections are in said second configuration and said base is configured to receive said footboard when said sections are in said second configuration.
13. A patient support apparatus for supporting a patient above a floor surface, said patient support apparatus comprising:
a litter having a patient support surface for supporting the patient;
a footboard operatively attached to said litter;
a base supporting said litter; and
a lift system comprising first and second lift members, said first and second lift members extending from said base to said litter, with said first lift member being arranged on a first side of said patient support apparatus and said second lift member being arranged on a second side opposite said first side, and coupling said litter to said base, said lift system being configured to move said litter relative to said base,
said litter comprising a seat section and a foot section extending continuously and longitudinally from said seat section to a foot section end, having no rotationally articulating joints disposed between a top of the foot section adjacent to and directly attached to said seat section and said foot section end, with said footboard operatively attached to said foot section end,
wherein said patient support surface comprises a foot section patient support surface defined by said foot section,
wherein said litter has a first configuration in which said seat and foot sections are aligned generally horizontally above the floor surface such that said foot section patient support surface faces away from said base and a second configuration in which said foot section patient support surface faces toward said base with said foot section extending continuously and longitudinally from said seat section to said footboard, said foot section being configured to articulate between said first and second lift members such that said foot section is stowed in the second configuration beneath said seat section, between said seat section and said base, and between said first and second lift members;
wherein said footboard is movably coupled to said foot section with said foot section disposed longitudinally between said seat section and said footboard;
wherein said footboard is movable relative to said foot section between a deployed position and a collapsed position, with said footboard being biased into said deployed position by a biasing device; and
wherein said footboard is configured to abut the floor surface when said foot section is moved to said second configuration such that an actuation force is applied by the floor surface on said footboard against a biasing force from said biasing device to move said footboard from said deployed position to said collapsed position.
14. The patient support apparatus of claim 13, wherein said second configuration comprises a chair configuration, said foot section being movable relative to said seat section when moving from said first configuration to said chair configuration.
15. The patient support apparatus of claim 14, wherein said foot section has a first width and said lift members are spaced apart at a second width greater than said first width so that said foot section is movable between said lift members to be stowed beneath said seat section and between said lift members when moving from said first configuration to said chair configuration.
16. The patient support apparatus of claim 13, wherein said base defines a foot end and a head end and said base comprises two foot end support features disposed at said foot end to support said base on the floor surface.
17. The patient support apparatus of claim 16, wherein said base defines an open space between said foot end support features, said open space configured to be open to the floor surface between said foot end support features to receive feet of the patient between said foot end support features when said sections are in said second configuration.
18. The patient support apparatus of claim 17, wherein said foot end support features are spaced apart by a first width and said foot section has a second width narrower than said first width and said foot section is configured to move at least partially within said open space between said foot end support features when said foot section moves from said first configuration to said second configuration.
19. The patient support apparatus of claim 13, wherein said base defines a receiving space to receive at least one of said footboard and said foot section when said sections are in said second configuration such that at least one of said footboard and said foot section nests with said base.
20. The patient support apparatus of claim 13, wherein said lift system comprises
a first actuator coupled to said lift members and said base to pivot said lift members relative to said base and move said litter relative to said base;
a second actuator coupled to said lift members and said seat section to move said lift members relative to said seat section and tilt said seat section and said litter relative to said base;
a third actuator coupled to said foot section to move said foot section relative to said seat section; and
a fourth actuator, wherein said litter comprises a fowler section and said fourth actuator is coupled to said fowler section to move said fowler section relative to said seat section.
21. The patient support apparatus of claim 13, wherein said defines a barrier with respect to said foot section in said deployed position and said footboard is collapsed with respect to said foot section in said collapsed position.
22. The patient support apparatus of claim 13, wherein said footboard being orthogonal to said foot section in said deployed position and said footboard being configured to rotate relative to said foot section and toward said foot section to move to said collapsed position.
23. The patient support apparatus of claim 13, further comprising a mattress disposed on said foot section, wherein said footboard is movable relative to said foot section between a deployed position and a collapsed position, with said footboard configured to trap bedding disposed on said mattress against said mattress when said footboard is in said collapsed position.
24. The patient support apparatus of claim 13, wherein said footboard is configured to be in said collapsed position when said sections are in said second configuration and said base is configured to receive said footboard when said sections are in said second configuration.
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RELATED APPLICATIONS
This application claims priority to and the benefit of U.S. Provisional Patent Application No. 62/382,871, filed on Sep. 2, 2016, and which is hereby incorporated by reference in its entirety.
BACKGROUND
Patient support systems facilitate care of patients in a health care setting. Patient support systems comprise patient support apparatuses such as, for example, hospital beds, stretchers, cots, and wheelchairs. Conventional patient support apparatuses comprise a base and a litter upon which the patient is supported. Often, patient support apparatuses have a lift system that may be used to raise and lower the litter and thus the patient relative to the base. These litters typically have several sections, including a fowler section, a seat section, and a foot section with the fowler section and the foot section being capable of articulation relative to the seat section via articulation actuators. On some occasions, the lift system in conjunction with the articulation actuators may move the litter relative to the base while articulating one or more of the sections such that the litter is reconfigured from a bed configuration to a chair configuration.
A patient support apparatus being able to move from a bed configuration to a chair configuration helps patients with limited mobility get into a position that will enable them to regain mobility more easily. Typically, when the litter is moved to the chair configuration from the bed configuration, the foot section is lowered to a generally vertical orientation, which limits lowering of the litter. In some instances, the foot section includes a footboard. Typically, to move the litter into the chair configuration, the footboard must be removed from the foot section for the patient to be able to reach a floor surface. The patient support apparatus often includes a mattress disposed on the litter for patient comfort. Typically, when the litter moves from the bed configuration to the chair configuration, the mattress encounters difficulty in folding with the foot section relative to the seat section into the chair configuration. A patient support apparatus designed to overcome one or more of the aforementioned challenges is desired.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective view of a patient support apparatus.
FIG. 2A is an elevational view of a litter in a first configuration.
FIG. 2B is an elevational view illustrating a partial cross-section of FIG. 2A.
FIG. 3A is a perspective view of the litter in a second configuration.
FIG. 3B is an elevational view illustrating a partial cross-section of FIG. 3A.
FIG. 4 is a plan view showing individual sections of the litter and features of a base supporting the litter.
FIG. 5A is an elevational view of the litter in an intermediate configuration.
FIG. 5B is an elevational view illustrating a partial cross-section of FIG. 5A.
FIG. 6A is a perspective view of the litter supported by an alternative embodiment of the base.
FIG. 6B is a perspective view illustrating the litter in another intermediate configuration.
FIG. 7A is an elevational view of the litter in an alternative intermediate configuration.
FIG. 7B is an elevational view illustrating a partial cross-section of FIG. 7A.
FIG. 7C is an elevational cross section view of the patient support apparatus in the second configuration of FIG. 3A.
FIG. 8 is an elevational view illustrating a foot section of the litter being in a fully extended position.
FIG. 9 is an elevational view illustrating the foot section of the litter being in an intermediate position between the fully extended position and a fully retracted position.
FIG. 10 is an elevational view illustrating the foot section of the litter being in a fully retracted position.
FIG. 11 is a schematic view of a control system for the patient support apparatus.
FIG. 12A is a cross-sectional view of one embodiment of a foot mattress segment of a mattress assembly being integrated with the foot section of the litter.
FIG. 12B is a cross-sectional view of another embodiment of the foot mattress segment of the mattress assembly being integrated with the foot section of the litter and having a first tension.
FIG. 12C is a cross-sectional view of another embodiment of the foot mattress segment of the mattress assembly being integrated with the foot section of the litter and having a second tension.
FIG. 13A is an elevational and partially cross-sectional view of one embodiment of the mattress assembly.
FIG. 13B is an elevational and partially cross-sectional view of another embodiment of the mattress assembly with a seat conformable layer and a fowler conformable layer fixed to a seat section and a fowler section, respectively.
FIG. 13C is an elevational and partially cross-sectional view of a further embodiment of the mattress assembly with the seat conformable layer and the fowler conformable layer configured to move relative to the seat section and the fowler section, respectively.
FIG. 13D is an elevational and partially cross-sectional view of a further embodiment of the mattress assembly.
FIG. 14A is an elevational and partially cross-sectional view of another configuration of sections of the litter.
FIG. 14B is an elevational and partially cross-sectional view of a further configuration of the sections of the litter.
FIG. 14C is an elevational and partially cross-sectional view of a further configuration of the sections of the litter.
FIG. 14D is an elevational and partially cross-sectional view of a further configuration of the sections of the litter.
FIG. 14E is an elevational and partially cross-sectional view of a further configuration of the sections of the litter.
DETAILED DESCRIPTION
Referring to FIG. 1, a patient support system comprising a patient support apparatus 20 is shown for supporting a patient in a health care setting. The patient support apparatus 20 illustrated in FIG. 1 comprises a hospital bed. In other embodiments, however, the patient support apparatus 20 may comprise a stretcher, cot, table, wheelchair, or similar apparatus utilized in the care of a patient.
A support structure provides support for the patient. The support structure illustrated in FIG. 1 comprises a base 24 and a litter 26. The litter 26 is spaced above the base 24. The litter 26 comprises several sections, some of which are capable of being articulated relative to each other, such as a fowler section 44, a seat section 40, and a foot section 42. The fowler section 44 and the foot section 42 may pivot relative to the seat section 40, or may articulate relative to the seat section 40 in any manner. For instance, the fowler section 44 and/or the foot section 42 may both pivot and translate relative to the seat section 40. The litter 26 provides a primary patient support surface 27 upon which the patient is supported.
A mattress 29 may be disposed on or integral with the litter 26. The mattress 29 comprises a secondary patient support surface 28 upon which the patient is supported. The base 24, litter 26, and patient support surfaces 27, 28 each have a head end and a foot end corresponding to designated placement of the patient's head and feet on the patient support apparatus 20. The construction of the support structure may take on any known or conventional design, and is not limited to that specifically set forth above. In addition, the mattress 29 may be omitted in certain embodiments, such that the patient rests directly on the patient support surface 27. In many embodiments, the mattress 29 is integrated with at least a portion of the litter 26. Details regarding embodiments where the mattress 29 is integrated with the litter 26 are discussed further below.
Side rails 30, 32, 34, 36 are coupled to the litter 26 and thereby supported by the base 24. A first side rail 30 is positioned at a right head end of the litter 26. A second side rail 32 is positioned at a right foot end of the litter 26. A third side rail 34 is positioned at a left head end of the litter 26. A fourth side rail 36 is positioned at a left foot end of the litter 26. If the patient support apparatus 20 is a stretcher or a cot, there may be fewer side rails. The side rails 30, 32, 34, 36 are movable between a raised position in which they block ingress and egress into and out of the patient support apparatus 20 and a lowered position in which they are not an obstacle to such ingress and egress and/or one or more intermediate positions therebetween. In still other configurations, the patient support apparatus 20 may not include any side rails.
A headboard may be coupled to the litter 26. In other embodiments, the headboard may be coupled to other locations on the patient support apparatus 20, such as the base 24. In still other embodiments, the patient support apparatus 20 does not include the headboard.
Caregiver interfaces 38, such as handles, are shown integrated into side rails 30, 32, 34, 36 to facilitate movement of the patient support apparatus 20 over floor surfaces. Additional caregiver interfaces 38 may be integrated into the headboard and/or other components of the patient support apparatus 20. The caregiver interfaces 38 are graspable by the caregiver to manipulate the patient support apparatus 20 for movement. In other embodiments, the patient support apparatus 20 does not include caregiver interfaces 38.
It should be noted that in many of the figures described herein, certain components of the patient support apparatus 20 have been removed for convenience of description and ease of illustration.
Referring to FIGS. 2A and 2B, the litter 26 comprises the seat section 40 and the foot section 42 coupled to the seat section 40. In many embodiments, the litter 26 further comprises the fowler section 44 coupled to the seat section 40 such that the seat section 40 is between the foot and fowler sections 42, 44. The patient support apparatus 20 comprises a lift system 46 coupled to the litter 26 and the base 24. The lift system 46 comprises a pair of lift members 48 coupling the litter 26 to the base 24. The lift system 46 is configured to move the litter 26 relative to the base 24.
The foot section 42 is configured and arranged to articulate relative to the seat section 40 between a first configuration 50 (shown in FIGS. 2A and 2B) in which the seat, foot, and fowler sections 40, 42, 44 are aligned generally horizontally above a floor surface and a second configuration 52 (shown in FIGS. 3A and 3B) in which the foot section 42 is stowed beneath the seat section 40 between the pair of lift members 48 and the fowler section 44 is raised relative to the seat section 40. The lift members 48 are arranged such that the lift members 48 do not impede movement (e.g. articulation) of the foot section 42 relative to the seat section 40 when the litter 26 is in the first configuration 50, the second configuration 52, and every configuration between the first and second configurations 50, 52. Further, the foot section 42 is configured to move between the lift members 48 when the litter 26 moves from the first configuration 50 to the second configuration 52. It should be appreciated that the patient support apparatus 20 may comprise one or more sections disposed between and configured to articulate relative to the seat section 40 and the foot section 42.
In one embodiment, shown in FIG. 14C and discussed in more detail below, the foot section 42 comprises one or more sections configured and arranged to articulate relative to each other.
The litter 26 has at least one intermediate configuration between the first and second configurations 50, 52. In one embodiment, the intermediate configuration is a bed exit configuration with the seat and foot sections 40, 42 tilted forward such that a patient may exit the bed toward the foot section 42. This position is helpful for patients having limited mobility to regain their lost mobility. Another embodiment of the intermediate configuration is shown in FIGS. 5A and 5B in which the seat section 40 is tilted so that the patient is somewhat limited in being able to easily exit yet still be placed in a seated position.
In one embodiment as shown in FIGS. 3A and 3B, the second configuration 52 is a chair configuration. In another embodiment, the first configuration and the second configuration are any two distinct configurations of the litter 26. The foot section 42 rotates or otherwise articulates relative to the seat section 40 when the litter 26 moves between the first configuration 50 and the second configuration 52.
Referring specifically to FIG. 3B, the seat section 40 and the foot section 42 each define a top surface 54, 56, respectively, and bottom surfaces 58, 60 opposite the top surfaces 54, 56. In the first configuration 50, the top surfaces 54, 56 face away from the base 24. The bottom surface 60 of the foot section 42 faces the bottom surface 58 of the seat section 40 when the litter 26 is in the second configuration 52.
In one embodiment shown in FIG. 4, the foot section 42 comprises a first width 62. The pair of lift members 48 are spaced apart at a second width 64 greater than the first width 62 so that the foot section 42 is movable between the lift members 48. The foot section 42 is configured to be stowed beneath the seat section 40 and between the lift members 48 when moving from the first configuration 50 to the second configuration 52.
In one embodiment, the seat section 40 comprises a third width 66 that is greater than the first width 62. In one embodiment, the first width 62 is less than thirty-five inches. In other embodiments, the first width 62 is greater than or equal to thirty-five inches.
The base 24 comprises a foot end 68 and a head end 70. The base 24 further comprises at least two foot end support features 72 disposed at the foot end 68 to support the base 24 on the floor surface. In one embodiment, the foot end support features 72 comprise a pair of arms extending from the base with a caster wheel coupled to each arm for engagement with the floor surface.
In one embodiment, when the litter 26 is in the second configuration 52, the foot section 42 is beneath the seat section 40 and the foot end support features 72 are arranged with respect to the seat section 40 such that a patient's legs and feet hanging off the edge of the seat section 40 would not contact the foot end support features 72, but instead could reach the floor surface directly between the foot end support features 72. The base 24 defines an open space 74 between the foot end support features 72. The open space 74 is configured to be open to the floor surface between the foot end support features 72 and to receive feet of the patient between the foot end support features 72 when the litter 26 is in the second configuration 52. In other embodiments, not shown, the foot end support features 72 may be located directly beneath the seat section 40 such that the foot end support features 72 are not an obstacle to the patient when attempting to exit.
As shown in FIG. 4, the foot end support features 72 comprise an accommodation width 76. The accommodation width 76 is greater than the first width 62. Said differently, the foot end support features 72 are spaced apart to be wider than the width of the foot section 42 so that the foot section 42 may freely move between the foot end support features 72. The foot section 42 is configured to move at least partially within the open space 74 between the foot end support features 72 when the foot section 42 moves between the first configuration 50 and the second configuration 52.
In one embodiment, referring to FIGS. 6A and 6B, the patient support apparatus 20 further comprises a footboard 78 movably coupled to the foot section 42. The foot section 42 is disposed between the seat section 40 and the footboard 78. The footboard 78 is movable with the foot section 42 between the first configuration 50 and the second configuration 52. The footboard 78 is also movable relative to the foot section 42 between a deployed position 80 in which the footboard 78 defines a barrier with respect to the foot section 42 and a collapsed position 82 in which the footboard 78 is collapsed with respect to the foot section 42. In the deployed position, the barrier serves to prevent the patient from exiting the patient support apparatus 20 from the foot end. The footboard 78 is biased into the deployed position 80 by a biasing device 83. In some embodiments, as shown in FIGS. 14A-14D, the patient support apparatus 20 does not comprise a footboard 78.
In one embodiment, the biasing device 83 may comprise one or more tension springs, or other types of biasing devices (such as compression springs, gas springs, torsion springs, and the like). The footboard 78 is orthogonal to the foot section 42 in the deployed position 80. In alternative embodiments, the footboard 78 is in the deployed position 80 when the footboard 78 is at an angle greater than ninety degrees relative to the foot section 42. In further embodiments, the footboard 78 is in the deployed position 80 when the footboard 78 is at an angle less than ninety degrees relative to the foot section 42. The angle of the footboard 78 relative to the foot section 42 in the collapsed position 82 is less than the angle of the footboard 78 relative to the foot section 42 in the deployed position 80. The footboard 78 comprises a proximal end 84 coupled to the foot section 42 and a distal end 86 opposite the proximal end 84. The footboard 78 is configured to rotate or otherwise articulate relative to the foot section 42 such that the distal end 86 of the footboard 78 rotates toward the foot section 42. The distal end 86 of the footboard 78 is configured to make contact with the foot section 42, or at least a portion of the mattress 29 disposed on the foot section 42, when the footboard 78 is in the collapsed position 82.
The footboard 78 may be configured to rotate or otherwise articulate relative to the foot section 42 in a range of about ninety degrees, greater than ninety degrees, greater than one hundred eighty degrees, and/or greater than two hundred seventy degrees. For instance, the footboard 78 may articulate from its deployed position toward the mattress 29 to achieve between zero and ninety degrees of rotation, but additionally, or alternatively, may be configured to articulate from its deployed position away from the mattress 29. In the latter case, the footboard 78 may articulate until the footboard 78 is parallel with the foot section 42, e.g., it has been rotated about ninety degrees in a direction opposite the mattress 29 to be disposed one hundred eighty degrees from the foot section 42. Moreover, the footboard 78 may be configured to further rotate beyond one hundred eighty degrees and back toward the foot section 42, albeit now toward the bottom surface of the foot section 42.
In some embodiments, the footboard 78 is at an angle less than ninety degrees relative to the foot section 42 when the footboard 78 is in the collapsed position 82 and the distal end 86 of the footboard 78 does not make contact with the foot section 42 or the mattress 29 disposed on the foot section 42. In other words, the collapsed position 82, as shown for instance in FIG. 6B is any position to which the footboard 78 has moved toward the foot section 42 away from the deployed position 80.
In one embodiment, the mattress 29 is configured to move with the foot section 42 between the first and second configurations 50, 52. The footboard 78 is configured to trap bedding disposed on the mattress 29 against the mattress 29 when the footboard 78 is in the collapsed position 82. In some embodiments, the footboard 78 is able to trap bedding disposed on the mattress 29 in a position between the deployed and collapsed position 80, 82. Bedding may include sheets, blankets, comforters, covers, or any other bedding material conventionally used with mattresses.
In one embodiment shown in FIGS. 5A and 5B, the base 24 is configured to receive the footboard 78 when the litter 26 is moved to the second configuration 52. The base 24 may comprise a receiving space 88 to receive at least one of the footboard 78 and the foot section 42 when the sections 40, 42 are in the second configuration 52 such that at least one of the footboard 78 and foot section 42 at least partially nest with the base 24. The base 24 comprises an actuation surface 90 configured to engage the footboard 78 and move the footboard 78 from the deployed position 80 to the collapsed position 82 when the foot section 42 moves to the second configuration 52. In one embodiment, the receiving space 88 is recessed into the base 24. In an alternative embodiment, the receiving space 88 is a cutout in the base 24 that is open to the floor surface.
In other embodiments as shown in FIGS. 6A and 6B, the base 24 comprises an actuation opening 92 that is open to the floor surface. The foot section 42 may freely move within the actuation opening 92 and the floor surface engages the footboard 78 to move the footboard 78 from the deployed position 80 to the collapsed position 82. In many embodiments, the footboard 78 is arranged to be in the collapsed position 82 when the litter 26 is in the second configuration 52. However, the footboard 78 may be arranged in any suitable manner relative to the foot section 42 when the litter 26 is in the second configuration 52. For instance, the footboard 78 may remain in its deployed orientation relative to the foot section 42 (e.g., generally orthogonal to the foot section 42), the footboard 78 may be directed toward a head end of the patient support apparatus 20, the footboard 78 may be directed toward a foot end of the patient support apparatus 20, or the footboard 78 may be oriented in any other suitable orientation when the litter 26 is in the second configuration 52.
The footboard 78 is configured to abut one of the actuation surface 90 and the floor surface when the foot section 42 is moved to the second configuration 52 such that an actuation force is applied by one of the actuation surface 90 and the floor surface on the footboard 78 against a biasing force from the biasing device 83 to move the footboard 78 from the deployed position 80 to the collapsed position 82. In one embodiment, the footboard 78 is configured to abut one of the actuation surface 90 and the floor surface when the foot section 42 is vertically oriented relative to the floor surface to begin moving the footboard 78 from the deployed position 80 to the collapsed position 82. In other embodiments, the footboard 78 is configured to abut one of the actuation surface 90 and the floor surface when the foot section 42 is non-vertically oriented relative to the floor surface to begin moving the footboard 78 from the deployed position 80 to the collapsed position 82.
As shown in FIGS. 7A and 7B, the lift system 46 comprises a first actuator 100 coupled to one of the lift members 48 and the base 24 at an end of the lift member 48 coupled to the base 24. The first actuator 100 pivots the pair of lift members 48 relative to the base 24 and moves the litter 26 relative to the base 24. The first actuator 100 is hereinafter referred to as the lift actuator 100. In some cases a rigid link (e.g., connecting shaft) interconnects the lift members 48 at their ends coupled to the base 24 so that operation of the lift actuator 100 simultaneously moves both of the lift members 48. In other embodiments, separate actuators for each lift member 48 are employed.
In one embodiment, the lift actuator 100 is a rotary actuator as described in one of U.S. Non-Provisional application Ser. No. 15/635,787, entitled PATIENT SUPPORT SYSTEMS WITH ROTARY ACTUATORS, filed on Jun. 28, 2017; U.S. Non-Provisional application Ser. No. 15/635,836, entitled PATIENT SUPPORT SYSTEMS WITH ROTARY ACTUATORS COMPRISING ROTATION LIMITING DEVICES, filed on Jun. 28, 2017; U.S. Non-Provisional application Ser. No. 15/635,802, entitled PATIENT SUPPORT SYSTEMS WITH HOLLOW ROTARY ACTUATORS, filed on Jun. 28, 2017; U.S. Non-Provisional application Ser. No. 15/635,826, entitled PATIENT SUPPORT SYSTEMS WITH ROTARY ACTUATORS HAVING CYCLOIDAL DRIVES, filed on Jun. 28, 2017; and U.S. Non-Provisional application Ser. No. 15/635,817, entitled ROTARY ACTUATOR HAVING CLUTCH ASSEMBLY FOR USE WITH PATIENT SUPPORT APPARATUS, filed on Jun. 28, 2017, each of which is hereby incorporated by reference in its entirety. In this embodiment, the lift members 48 are movable members and the lift actuator 100 drives relative movement between the lift members 48 and the base 24 to articulate (e.g., pivot) the lift members 48 relative to the base 24. In this manner, the litter 26 is raised relative to the base 24. The lift actuator 100 comprises a motor (not shown) to provide power for the lift actuator 100 to drive the lift actuator 100 in a forward driving condition. In other embodiments, the lift actuator 100 is a linear actuator or other actuators are also contemplated.
The lift system 46 further comprises a second actuator 102 coupled to one of the lift members 48 and a seat section support frame 96 of the seat section 40. In particular, the second actuator 102 is coupled to the lift member 48 at an end of the lift member 48 coupled to the seat support frame 96. The second actuator 102 moves the seat section 40 relative to the pair of lift members 48 and tilts the seat section 40 and the litter 26 relative to the base 24. The second actuator 102 is hereinafter referred to as the tilt actuator 102.
Referring to FIG. 7C, the seat section support frame 96 comprises a seat support frame base 96a disposed between two seat support frame plates 96b. The seat support frame plates 96b are coupled to the lift members 48 and the tilt actuator 102. In one embodiment, the seat support frame base 96a and the seat support frame plates 96b are one continuous piece. In other embodiments, the seat support frame base 96a and the seat support frame plates 96b comprise multiple components coupled together.
In one embodiment, the seat support frame plates 96b extend from the seat support frame base 96a toward the floor space to define a seat support frame interior 96c. In one embodiment, the seat support frame interior 96c receives the foot section 42 when the litter 26 is in the second configuration 52. In another embodiment, the foot section 42 is underneath the seat support frame base 96a when the litter 26 is in the second configuration 52.
In one embodiment, the tilt actuator 102 is a rotary actuator as described in one of the above identified U.S. Non-Provisional Applications incorporated by reference. In this embodiment, the seat support frame 96 is a movable member and the tilt actuator 102 drives relative movement between the seat support frame 96 and the lift members 48 to articulate the seat support frame 96 relative to the lift members 48. In this manner, the litter 26 is tilted relative to the base 24. The tilt actuator 102 comprises a motor (not shown) to provide power for the tilt actuator 102 to drive the tilt actuator 102 in a forward driving condition. In other embodiments, the tilt actuator 102 is a linear actuator or other actuators are also contemplated.
In one embodiment, the lift system 46 comprises exactly two lift members 48. The arrangement of two actuators 100, 102 on either end of the lift members 48 eliminates the need for additional support arms or members. Further, with the lift and tilt actuators 100, 102 driving and constraining movement of the lift members 48 relative to the base 24 and the seat support frame 96, respectively, there is no need for timing mechanisms such as four bar mechanisms or other timing mechanisms to stabilize the lift system 46.
In one embodiment, the lift and tilt actuators 100, 102 are not back drivable. Back drive occurs when a load is applied externally to the respective movable members of the lift and tilt actuators 100, 102, which creates torque in opposition to drive torque provided by the motor, that, if not checked, would otherwise rotate (in an opposite direction to the respective forward driving conditions of the lift and tilt actuators 100, 102)
A third actuator 104 is coupled to a foot section support frame 94 of the foot section 42 and the seat section support frame 96. The third actuator 104 is arranged to move (e.g., articulate) the foot section 42 relative to the seat section 40. The third actuator 104 is hereinafter referred to as the foot section actuator 104.
In one embodiment, the foot section actuator 104 is a rotary actuator as described in one of the above identified U.S. Non-Provisional Applications incorporated by reference. In this embodiment, the foot section support frame 94 is a movable member and the foot section actuator 104 drives relative movement between the seat section support frame 96 and the foot section support frame 94 to articulate the foot section support frame 94 relative to the seat section support frame 96. In this manner, the foot section 42 may be moved (e.g. articulated) beneath the seat section 40. In other embodiments, the foot section actuator 104 is a linear actuator or other actuators are also contemplated.
A fourth actuator 106 is coupled to a fowler section support frame 98 of the fowler section 44 and the seat section support frame 96. The fourth actuator 106 is arranged to move (e.g., articulate) the fowler section 44 relative to the seat section 40. The fourth actuator 106 is hereinafter referred to as the fowler section actuator 106.
In one embodiment, the fowler section actuator 106 is a rotary actuator as described in one of the above identified U.S. Non-Provisional Applications incorporated by reference. In this embodiment, the fowler section support frame 98 is a movable member and the fowler section actuator 106 drives relative movement between the fowler section support frame 98 and the seat section support frame 96 to articulate the fowler section support frame 98 relative to the seat section support frame 96. In other embodiments, the fowler section actuator 106 is a linear actuator or other actuators are also contemplated.
In one embodiment, as shown in FIGS. 8-10, the foot section support frame 94 comprises a proximal end 108 coupled to the seat section 40, a distal end 110 coupled to the footboard 78, and a length 112 between the proximal end 108 and the distal end 110. In one embodiment, the foot section support frame 94 is extendable relative to the seat section 40 such that the foot section support frame length 112 may be increased or decreased. FIGS. 8-10 show a progression of the foot section 42 extended and retracted.
In another embodiment, shown in FIG. 14C and described further below, the foot section 42 comprises multiple sections and the multiple sections may be articulated relative to each other such that the foot section 42 may be extended or retracted to adjust a length of the foot section 42.
In the embodiments described in the figures, one actuator is shown for each of the lift, tilt, foot section, and fowler section actuators 100, 102, 104, 106. In alternative embodiments, two or more actuators may be employed for each of the lift, tilt, foot section, and fowler section actuators 100, 102, 104, 106.
A fifth actuator 114 is coupled to the foot section 42 that extends and retracts the foot section support frame 94. The fifth actuator 114 is hereinafter referred to as the extension actuator 114. In the embodiments described in the figures, one actuator is shown for the extension actuator 114. In alternative embodiments, two or more actuators may be employed for the extension actuator 114.
As shown in FIGS. 8-10, the extension actuator is a linear actuator. The foot section support frame 94 comprises a first frame integral with the proximal end 108 and coupled to the seat section 40 and a second frame integral with the distal end 110 and coupled to the footboard 78. The second frame is movable relative to the first frame to extend the foot section support frame length 112. In this embodiment, the second frame is a movable member and the extension actuator 114 drives relative movement between the first and second frames to move the first frame relative to the second frame thus, the footboard 78 relative to the seat section support frame 96. In other embodiments, the extension actuator 114 is a rotary actuator as described in one of the above identified U.S. Non-Provisional Applications or other actuators are also contemplated. In some cases, if a rotary actuator is used in place of a linear actuator, a mechanical apparatus may additionally be employed to translate rotary movement from the rotary actuator to linear movement to move the first and second frames relative to each other to extend and retract the foot section 42 as desired. The mechanical apparatus may have a rack and pinion configuration, a lead screw configuration, or any other mechanical configuration known in the art to translate rotational movement to linear movement.
The foot section actuator 104 and the extension actuator 114 collectively form a foot section actuator system 116, while the foot section actuator system 116 and the fowler section actuator 106 collectively form an articulation system 49.
In another embodiment, instead of a biasing device 83 being used to bias the footboard 78 into the deployed position 80, the articulation system 49 further comprises a footboard actuator 117 (shown schematically in FIG. 11) coupled to the proximal end 84 of the footboard 78 and configured to move the footboard 78 from the deployed position 80 to the collapsed position 82.
In one embodiment, the footboard actuator 117 is a rotary actuator as described in one of the above identified U.S. Non-Provisional Applications incorporated by reference. In this embodiment, the footboard 78 is a movable member and the footboard actuator 117 drives relative movement between the footboard 78 and the foot section support frame 94 to articulate the footboard 78 relative to the foot section support frame 94. In other embodiments, the footboard actuator 117 is a linear actuator or other actuators are also contemplated.
Several embodiments illustrating arrangements of the sections of the litter 26 are shown in FIGS. 14A-14E and described below. Embodiments shown in FIGS. 14A-14D do not include the footboard 78, however, it is appreciated that the footboard 78 could be coupled to the foot section 42 as described in the above embodiments. Lift members 48 are shown in hidden lines for ease of illustrating the sections of the litter 26.
In embodiments shown in FIG. 14A-14C, an additional section, hereinafter referred to as a leg section 160, is disposed between the foot section 42 and the seat section 40. The leg section 160 comprises a leg section support frame 162. A leg section actuator 164, is coupled to the seat support frame 96 and the leg section support frame 162. The leg section actuator 164 is arranged to move (e.g. articulate) the leg section 160 relative to the seat section 40. The foot section actuator 104 is coupled to the leg section support frame 162 and the foot section support frame 94. The foot section actuator 104 is configured to move (e.g. articulate) the foot section 42 relative to the leg section 160.
In one embodiment, the leg section actuator 164 is a rotary actuator as described in one of the above identified U.S. Non-Provisional Applications incorporated by reference. In this embodiment, the leg section support frame 162 is a movable member and the leg section actuator 164 drives relative movement between the seat section support frame 96 and the leg section support frame 162 to articulate the leg section support frame 162 relative to the seat section support frame 96. In this manner, the leg section 160 may be moved (e.g. articulated) beneath the seat section 40. In other embodiments, the leg section actuator 164 is a linear actuator or other actuators are also contemplated.
In the embodiment illustrated in FIG. 14C, the foot section 42 comprises a first foot section 166 and a second foot section 168. The foot section support frame 94 comprises a first foot section support frame 170 corresponding to the first foot section 166 and a second foot section support frame 172 coupled to the first foot section support frame 170 and corresponding to the second foot section 168. Foot section actuator 104 is coupled to the leg section support frame 162 and the first foot section support frame 170. The foot section actuator 104 is arranged to move (e.g. articulate) the first foot section 166 relative to the leg section 160. An intermediate foot section actuator 174 (also referred to as an extension actuator) is coupled to the first foot section support frame 170 and the second foot section support frame 172. The intermediate foot section actuator 174 is arranged to move (e.g. articulate) the second foot section 168 relative to the first foot section 166. In some embodiments, as alluded to above, the intermediate foot section actuator 174 is arranged to move (e.g. articulate) the second foot section 168 relative to the first foot section 166 to effectively extend and retract the foot section 42 to adjust the length of the foot section 42 during use in the first configuration. It should be appreciated that, in some embodiments, the leg section 160 could be considered part of the foot section 42.
In one embodiment, the intermediate foot section actuator 174 is a rotary actuator as described in one of the above identified U.S. Non-Provisional Applications incorporated by reference. In this embodiment, the second foot section support frame 172 is a movable member and the intermediate foot section actuator 174 drives relative movement between the first foot section support frame 170 and the second foot section support frame 172 to articulate the second foot section support frame 172 relative to the first foot section support frame 170. In other embodiments, the intermediate foot section actuator 174 is a linear actuator or other actuators are also contemplated.
As shown in FIG. 11, a control system 118 is provided to control operation of the actuators 100, 102, 104, 106, 114, 117, 164, 174. The control system 118 comprises a controller 120 having one or more microprocessors for processing instructions or for processing an algorithm stored in memory to control operation of the actuators 100, 102, 104, 106, 114, 117, 164, 174. Additionally or alternatively, the controller 120 may comprise one or more microcontrollers, field programmable gate arrays, systems on a chip, discrete circuitry, and/or other suitable hardware, software, or firmware that is capable of carrying out the functions described herein. The controller 120 may be carried on-board the patient support apparatus 20, or may be remotely located. In one embodiment, the controller 120 is mounted to the base 24. The controller 120 may comprise one or more subcontrollers configured to control one or more actuators or one or more subcontrollers for each of the actuators 100, 102, 104, 106, 114, 117, 164, 174. Power to the actuators 100, 102, 104, 106, 114, 117, 164, 174 and/or the controller 120 may be provided by a battery power supply or an external power source 122.
The controller 120 is coupled to the actuators 100, 102, 104, 106, 114, 117, 164, 174 in a manner that allows the controller 120 to control the actuators 100, 102, 104, 106, 114, 117, 164, 174. The controller 120 may communicate with the actuators 100, 102, 104, 106, 114, 117, 164, 174 via wired or wireless connections. The controller 120 generates and transmits control signals to the actuators 100, 102, 104, 106, 114, 117, 164, 174, or otherwise cause the actuators to perform one or more of the desired functions.
The controller 120 controls operation of the actuators 100, 102, 104, 106, 114, 117, 164, 174. More specifically, the controller 120 may monitor a current state of the actuators 100, 102, 104, 106, 114, 117, 164, 174 and determine desired states in which the actuators 100, 102, 104, 106, 114, 117, 164, 174 should be placed, based on one or more input signals that the controller 120 receives from one or more user input devices 124. Alternatively, the controller 120 may monitor a position of the fowler section 44, seat section 40, leg section 160, foot section 42, and/or footboard 78 and determine desired positions of the fowler section 44, seat section 40, leg section 160, foot section 42, and/or footboard 78.
The caregiver, or other user, may actuate one of the user input devices 124, which transmits a corresponding input signal to the controller 120, and the controller 120 controls operation of the corresponding actuator based on the input signal. Operation of the corresponding actuator may continue until the caregiver discontinues actuation of the user input device 124, e.g., until the input signal is terminated. In other words, depending on which user input device 124 is engaged, i.e., what input signal is received by the controller 120, the controller 120 controls operation of one or more of the actuators 100, 102, 104, 106, 114, 117, 164, 174. In certain embodiments, the controller 120 selects or initiates operation of one or more of the actuators 100, 102, 104, 106, 114, 117, 164, 174 based on the input signals received by the controller 120.
The user input devices 124 may comprise devices capable of being actuated by a user, such as the caregiver or the patient. The user input devices 124 may be configured to be actuated in a variety of different ways, including but not limited to, mechanical actuation (hand, foot, finger, etc.), hands-free actuation (voice, foot, etc.), and the like. Each user input device 124 may comprise a button, a gesture sensing device for monitoring motion of hands, feet, or other body parts of the caregiver (such as through a camera), a microphone for receiving voice activation commands, a foot pedal, and a sensor (e.g., infrared sensor such as a light bar or light beam to sense a user's body part, ultrasonic sensor, etc.). Additionally, the buttons/pedals can be physical buttons/pedals or virtually implemented buttons/pedals such as through optical projection or on a touchscreen. It should be appreciated that any combination of user input devices 124 may also be utilized for any of the actuators. The user input devices 124 may be located on one of the side rails 30, 32, 34, 36, the headboard, the footboard 78, or other suitable locations. The user input devices 124 may also be located on a portable electronic device (e.g., iWatch®, iPhone®, iPad®, or similar electronic devices or any other remote device/station in addition to a portable electronic device).
In one embodiment, the patient support apparatus 20 comprises a user control panel that comprises numerous user input devices 124 in the form of buttons. The buttons may be mechanical press buttons, virtual buttons on a touch screen, and the like. Furthermore, as should be appreciated, the patient support apparatus may comprise any number of actuators and the corresponding user input devices 124. Each of the buttons control different predetermined functions of one or more of the actuators.
In order for the caregiver to continue operating one of the actuators 100, 102, 104, 106, 114, 117, 164, 174 to perform the desired function using one of the buttons (or other user input devices 124), the caregiver may be required to continue actuating (e.g., continue depressing or continue touching) the button until the caregiver is satisfied with the adjustment that was made to the actuator. Other user input devices 124 can be continually actuated in other ways, depending on their mode of actuation. For instance, an infrared sensor that generates a light beam can be continually actuated by continually breaking the light beam. Similarly, a gesture sensing device can be continually actuated by continually sensing an actuating gesture.
In some cases, this requirement that the caregiver continually actuate (e.g., continually depress or continually touch) the button (or other user input device 124) to cause energization of the actuator prevents the caregiver from performing other tasks that could be performed instead, such as assisting the patient with other needs. Accordingly, in certain embodiments described herein, the user input devices 124 are configured to also enable continued operation (i.e., energization) of the actuator, even after the caregiver ceases to actuate the user input device 124, e.g., after the caregiver ceases to depress or touch one of the buttons, for a predetermined period of time, or until the desired adjustment is complete.
As previously discussed, the user input devices 124, are capable of generating numerous input signals associated with one or more of the actuators 100, 102, 104, 106, 114, 117, 164, 174. For instance, each of the buttons generate a different first input signal associated with each of the different functions assigned to the buttons. The controller 120 is configured to recognize which input signal is being received so that the controller 120 can operate the actuators 100, 102, 104, 106, 114, 117, 164, 174 appropriately to perform the assigned functions.
In some embodiments, the controller 120 is configured to initiate operation of the lift system 46 in response to receiving the first input signal when the caregiver presses the button to operate the actuator to either lift or lower the litter 26.
In further embodiments, operation of the lift system 46 is dependent on a triggering event that causes the controller 120 to operate the lift system 46 to move the patient from a current patient condition (e.g., a current patient elevation) to a desired patient condition (e.g., a desired patient elevation).
Embodiments for controlling actuators 100, 102, 104, 106, 114, 117, 164, 174 to effect various configurations of the sections of the litter 26 when placing the litter 26 in the second configuration 52 are described below and illustrated in FIGS. 14A-14E. Additional configurations of the sections of the litter 26 are possible. In many embodiments, actuators 100, 102, 104, 106, 114, 117, 164, 174 are configured to articulate sections of the litter 26 in more than one direction relative to each other to effect a number of configurations of the sections of the litter 26.
In one embodiment, as shown in FIG. 14A, the controller 120 is configured to control articulation of the leg section 160 relative to the seat section 40 such that the leg section support frame 162 articulates away from the mattress 29 disposed on the seat section support frame 96. The controller 120 is configured to control articulation of the foot section 42 relative to the leg section 160 such that the foot section support frame 94 articulates away from the mattress 29 disposed on the leg section support frame 162. In a variation of that shown in FIG. 14A, the controller 120 could control the leg section actuator 164 to further rotate the leg section 160 toward the seat section 40, while the foot section 42 remains parallel to the leg section 160 or with the foot section 42 articulated in an opposite direction relative to the leg section 160.
In another embodiment, as shown in FIG. 14B, the controller 120 is configured to control articulation of the foot section 42 relative to the leg section 160 such that the foot section support frame 94 articulates toward the mattress 29 disposed on the leg section support frame 162 (e.g., the foot section 42 is folded toward the leg section 160). In some embodiments, the mattress 29 is configured to deflate or otherwise compress (as shown in FIG. 14B) to permit the foot section support frame 94 to articulate closer to the leg section support frame 162. In a variation of that shown in FIG. 14B, the controller 120 could be configured to operate the foot section actuator 104 to articulate the foot section 42 toward the leg section 160 but in the opposite direction to that shown in FIG. 14B such that the foot section 42 and the leg section 160 are similarly collapsed (e.g., folded) together, but bottom-to-bottom instead of mattress-to-mattress. In this version, the controller 120 would articulate the foot section 42 toward the leg section 160 prior to the leg section 160 being moved by the controller 120 to place the litter 26 in the second configuration 52.
In one embodiment, as shown in FIG. 14C, the controller 120 is configured to control articulation of the second foot section 168 relative to the first foot section 166 such that the second foot section support frame 172 articulates slightly away from the mattress 29 disposed on the first foot section support frame 170. In variations of that shown in FIG. 14C, the controller 120 could be configured to operate the intermediate foot section actuator 174 to fold the first foot section 166 and the second foot section 168 together (in either direction as described above) or to fold all of the first foot section 166, the second foot section 168, and the leg section 160 together in any manner.
In one embodiment, as shown in FIG. 14D, the controller 120 is configured to control articulation of the foot section 42 relative to the seat section 40.
In one embodiment, as shown in FIG. 14E, the controller 120 is configured to control articulation of the sections of the litter 26 to put the litter 26 in a configuration that assists the patient with exiting the patient support apparatus 20, e.g. by placing the litter 26 into a standing or nearly upright configuration in which the sections 40, 42, 44 are parallel and inline. In this embodiment, the lift and tilt actuators 100, 102 may be controlled by the controller 120 to be positioned as shown or to further lower the footboard 78 (and/or the foot section 42) to the floor surface.
In one embodiment, the controller 120 is configured to control articulation and extension of the foot section 42 relative to the seat section 40 to maintain at least one predetermined positional criterion 126. The predetermined positional criterion 126 comprises maintaining a minimum distance between a location on the foot section 42 and the floor surface, maintaining a constant distance between the footboard 78 and the feet of the patient, mitigating shear on legs of the patient, and any combination thereof.
In one embodiment, the patient's legs are disposed on top of the mattress 29 with the mattress 29 being disposed above a joint between the foot section 42 and the seat section 40. A pivot point at the patient's knee and the joint between the foot section 42 and the seat section 40 may not be aligned. In this case, the controller 120 coordinates operation of the extension actuator 114 and the foot section actuator 104 to mitigate shear on the patient's legs resulting from misalignment of the pivot point of the patient's knee with the joint between the foot section 42 and the seat section 40 throughout articulation of the foot section 42 between the first configuration 50 and the second configuration 52. For instance, as the foot section 42 is articulated downwardly, the foot section 42 is simultaneously retracted and as the foot section 42 is articulated upwardly, the foot section 42 is simultaneously extended. The simultaneous extension/retraction can be at a constant rate relative to the articulation rate or at a variable rate relative to the articulation rate.
In one embodiment, the controller 120 is configured to control the foot section actuator system 116 to simultaneously extend or retract the foot section 42 while articulating the foot section 42 relative to the seat section 40 to maintain the minimum distance between the location on the foot section 42 and the floor surface. In another embodiment, the controller 120 is configured to control the foot section actuator system 116 to simultaneously extend or retract the foot section 42 while articulating the foot section 42 relative to the seat section 40 to maintain the constant distance between the footboard 78 and the feet of the patient. In other embodiments, the controller 120 is configured to coordinate operation of the foot section actuator system 116 and other actuators of the lift system 46 and/or articulation system 49 to maintain the at least one predetermined positional criterion 126 that requires sustaining a position of one section of the litter 26 relative to another component of patient support apparatus 20. In still other embodiments, the controller 120 is configured to control operation of the individual actuators independently.
In one embodiment, the controller 120 coordinates operation of the lift actuator 100 and the tilt actuator 102 to move the litter 26 to an elevated position relative to the base 24 while maintaining the orientation of the litter 26 relative to the floor surface.
In one embodiment, when the litter 26 moves from the first configuration 50 to the second configuration 52, the controller 120 coordinates operation of the lift actuator 100, tilt actuator 102, and foot section actuator 104 to move the seat section 40, foot section 42, and footboard 78 through engagement with one of the actuation surface 90 and the floor surface. The controller 120 continues to coordinate operation of the lift, tilt, and foot section actuators 100, 102, 104 so that the footboard 78 is in constant engagement with one of the actuation surface 90 and the floor surface and the foot section 42 moves beneath the seat section 40 and towards the seat section 40 until the litter 26 is in the second configuration 52, or the controller 120 coordinates operation of the lift actuator 100, tilt actuator 102, foot section actuator 104 and footboard actuator 117 to move to the second configuration 52.
In another embodiment, the controller 120 coordinates operation of the fowler section actuator 106 to move the fowler section 44 with movement of the seat and foot sections 40, 42 from the first configuration 50 to the second configuration 52.
In another embodiment, the controller 120 coordinates operation of the extension actuator 114 to extend or retract the foot section 42 with movement of the seat section 40, foot section 42, and/or fowler section 44 from the first configuration 50 to the second configuration 52. Coordinated operation of any of the actuators described herein may be employed to coordinate motion transitioning between configurations.
In one embodiment, the controller 120 coordinates operation of the extension actuator 114 to maintain a predetermined positional criterion 126 as the litter 26 moves from the first configuration 50 to the second configuration 52.
Conventional mattresses encounter difficulty in moving with the foot section 42 as the foot section 42 moves beneath the seat section 40 and into the second configuration 52. In many embodiments, the mattress 29 comprises a mattress assembly 128 to accommodate the change in geometry.
As shown in FIGS. 12A-12C, the mattress assembly 128 comprises a foot mattress segment 130 integral with the foot section 42 and movable with the foot section 42 to the stowed position beneath the seat section 40 with the foot mattress segment 130 retaining its position relative to the foot section 42 during articulation between the first configuration 50 and the second configuration 52. FIG. 12A illustrates a cross-section of a first embodiment of the foot mattress segment 130 and FIGS. 12B and 12C illustrate a cross-section of a second embodiment of the foot mattress segment 130 having a tension adjuster 156. In these embodiments, the foot mattress segment 130 comprises a lower suspension layer 132 carried by the foot section support frame 94 and an upper conformable layer 134 coupled to the suspension layer 132. In other embodiments, the conformable layer 134 is coupled to the foot section support frame 94 and/or the suspension layer 132.
The suspension layer 132 is directly connected to the foot section support frame 94 and forms a mattress base of the foot mattress segment 130 to support weight of the patient on the foot section 42. The patient's weight is supported on the foot mattress segment 130 in a manner that causes the mattress base and the conformable layer 134 to at least partially conform in shape to a portion of the patient as shown in FIG. 12B.
In one embodiment, the foot section support frame 94 comprises a pair of frame members 94a, 94b spaced apart from each other and the suspension layer 132 spans between the frame members 94a, 94b. In one embodiment, the suspension layer 132 comprises a compliant material. In another embodiment, the suspension layer 132 comprises a textile. The textile may comprise fabric. Further, the fabric may be woven. More specifically, the woven fabric may be an elastomeric material. In other embodiments, the woven fabric comprises a polymer such as polyester. In certain embodiments, the suspension layer 132 comprises Dymetrol®. Additional suspension layers 132 may also be provided in some cases. Furthermore, the suspension layer 132 may be a continuous layer formed in one sheet or material, or the suspension layer 132 may comprise several strips of material spanning the frame members 94a, 94b. In this case, the strips may be spaced from each other to define gaps therebetween. In alternative embodiments, the suspension layer 132 comprises multiple layers of compliant material.
In one embodiment, the conformable layer 134 is bonded to the suspension layer 132. The conformable layer 134 may be heat bonded to the suspension layer 132, may be bonded to the suspension layer 132 with an adhesive, and the like. The conformable layer 134 may be connected to the suspension layer 132 using any suitable method for connecting these layers. In alternative embodiments, the conformable layer 134 is coupled to the suspension layer 132 by mechanical fasteners such as hooks, clips, buttons, and the like. In further embodiments, the suspension layer 132 is stitched or interwoven with the conformable layer 134.
In one embodiment, the conformable layer 132 comprises at least one of a foam, a gel, and a pod material. In other embodiments, the conformable layer 132 comprises each of a foam material, a gel material, and a pod material, one or more foam materials, one or more gel materials, one or more pod materials or any combinations thereof.
In one embodiment, the foot mattress segment 130 has a thickness of less than three inches. Conventional mattresses typically have thicknesses around nine inches. Reducing the overall thickness of the foot mattress segment 130 also reduces the overall height of the litter 26 relative to the floor surface when the litter 26 is in the second configuration 52 because the foot section 42 is stowed beneath the seat section 40, which would otherwise require the seat section 40, and thus the litter 26 as a whole, to be raised to accommodate a thicker mattress stowed beneath the seat section 40. In other embodiments, the foot mattress segment 130 has a thickness of three inches or more.
As shown in FIGS. 12B and 12C, the mattress assembly 128 comprises a tension adjuster 156 operatively coupled to the suspension layer 132 to adjust a tension of the suspension layer 132. The tension adjuster 156 may comprise a motor M and a winding element 157 (e.g., a spool). The winding element 157 is configured to receive the suspension layer 132 to wind and unwind the suspension layer 132. In some cases, an opposing end of the suspension layer 132 (opposite the winding element 157) is fixed in position so that tension can be applied to the suspension layer 132 by winding the suspension layer 132 on the winding element 157.
In one embodiment, the controller 120 is in communication with the motor M of the tension adjuster 156 to control the motor M. A sensor 158 (e.g., one or more strain gauges) may be employed to determine a current tension of the suspension layer 132. The controller 120 may be configured to control the motor M and adjust the tension of the suspension layer 132 in response to feedback from the sensor 158 so that the tension is set at a desired tension. In some cases, various tensions may be desired in the suspension layer 132 depending on the configuration in which the litter 26 is placed, or depending on other conditions associated with the patient support apparatus 20 or the patient. For instance, in the chair configuration a higher tension may be desirable so that the suspension layer 132 does not hang, but is instead sufficiently taut. This may also apply when the foot section 42 is raised relative to the seat section 40. In alternative embodiments, tension may be adjusted without the use of a sensor 158. In other embodiments, at least one of the seat section 40 and the fowler section 44 comprise suspension layers 132 and conformable layers 134. Each section 40, 42, 44 of the litter 26 may have one or more tension adjusters and one or more sensors. Tension may be adjusted within each section 40, 42, 44 and separately or independently in each section 40, 42, 44 as desired.
In another embodiment, the controller 120 is configured to determine a weight of at least a portion of the patient based on feedback from the sensor 158.
Various embodiments of the mattress assembly 128 are shown below in FIGS. 13A-13D. In one embodiment shown in FIG. 13A, the mattress assembly 128 comprises a fowler mattress segment 136 integral with the fowler section 44 and a seat mattress segment 138 integral with the seat section 40. The fowler mattress segment 136 and the seat mattress segment 138 are integrated in the sense that they are connected to the fowler section support frame 98 and the seat section support frame 96 to form part of the fowler section 44 and seat section 40, respectively.
In another embodiment shown in FIG. 13B, the mattress assembly 128 comprises a first connecting segment 140 interconnecting the fowler mattress segment 136 and the seat mattress segment 138. A second connecting segment 142 interconnects the seat mattress segment 138 and the foot mattress segment 130. The litter 26 comprises a first joint 144 between the fowler section 44 and the seat section 40 and a second joint 146 between the seat section 40 and the foot section 42. The foot section 42 is configured to move to the stowed position about the second joint 146. The mattress assembly 128 relies on the connecting segments 140, 142 to accommodate articulation about these joints 144, 146. The seat and fowler mattress segments 138, 136 are integral with the seat and fowler sections 40, 44, respectively. In particular, the connecting segments 140, 142 are configured to stretch about the joints 144, 146 such that the mattress segments 130, 136, 138 remain in a constant position relative to their associated support frames as the sections 40, 42, 44 move between the configurations.
In one embodiment shown in FIG. 13C, the seat and fowler mattress segments 138, 136 are not integral with the seat and fowler sections 40, 44, respectively. In contrast to FIG. 13B, the seat and fowler mattress segments 138, 136 are depicted with thinner lines than the foot mattress segment 130 to illustrate that they are not fixed to the seat and fowler sections 40, 44. Instead, the seat mattress segment 136 and the fowler mattress segment 138 are configured to slide against their respective support frames as required to accommodate the foot mattress segment 130 moving with the foot section 42 from the first configuration 50 to the second configuration 52.
In many embodiments, the mattress assembly 128 comprises an elastic covering 148 disposed over the mattress segments 130, 136, 138 and the connecting segments 140,142.
In one embodiment, the fowler mattress segment 136 comprises a fowler conformable layer 150 and the seat mattress segment 138 comprises a seat conformable layer 152. Each of the fowler conformable layer 150 and the seat conformable layer 152 may comprise at least one of foam and gel material. In other embodiments, each of the fowler conformable layer 150 and the seat conformable layer 152 comprises both a foam material and a gel material, one or more foam materials, one or more gel materials, or any combinations thereof.
In another embodiment shown in FIG. 13D, the seat and fowler mattress segments 138, 136 are replaced with one uniform conformable layer 154 that is integral with the conformable layer 134 of the foot mattress segment 130. The uniform conformable layer 154 is configured to move with the foot section 42 from the first configuration 50 to the second configuration 52, and move relative to the seat and fowler sections 40, 44 to accommodate being fixed relative to the foot section 42.
In one embodiment, at least one of the fowler mattress segment 136 and the seat mattress segment 138 comprise fluid bladders configured to provide therapy to the patient. A pump and fluid delivery system (not shown) may be provided to selectively provide fluid to the bladders. The pump and fluid delivery system may be located beneath the seat section 40 or beneath the fowler section 44, or otherwise accommodated on the patient support apparatus 20.
In another embodiment, the fluid bladders are used to provide active pressure distribution across at least one of the fowler mattress segment 136 and the seat mattress segment 138 to better distribute the weight of the patient and reduce pressure points.
In further embodiments, the fluid bladders are used to provide turn assistance to reduce the risk of a patient receiving bed sores from prolonged immobilization.
In one embodiment, the seat mattress segment 138 has a first thickness and the foot mattress segment 130 has a second thickness smaller than the first thickness. The fowler mattress segment 136 may have a similar first thickness as the seat mattress segment 138 such that the foot mattress segment 130 is thinner than both the fowler mattress segment 136 and the seat mattress segment 138.
It is to be appreciated that the terms “include,” “includes,” and “including” have the same meaning as the terms “comprise,” “comprises,” and “comprising.”
Several embodiments have been discussed in the foregoing description. However, the embodiments discussed herein are not intended to be exhaustive or limit the invention to any particular form. The terminology which has been used is intended to be in the nature of words of description rather than of limitation. Many modifications and variations are possible in light of the above teachings and the invention may be practiced otherwise than as specifically described.
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15693714
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stryker corporation
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USA
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B2
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Utility Patent Grant (with pre-grant publication) issued on or after January 2, 2001.
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Open
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Apr 20th, 2022 02:51PM
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Apr 20th, 2022 02:51PM
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Stryker
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Health Care
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Health Care Equipment & Services
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