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nyse:jnj
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Johnson & Johnson
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Apr 26th, 2022 12:00AM
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Feb 26th, 2020 12:00AM
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https://www.uspto.gov?id=USD0950070-20220426
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Adhesive bandage with decorated pad
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D950070
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We claim the ornamental design for an adhesive bandage with decorated pad, as shown and described.
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1
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FIG. 1 is a top perspective view of of the present invention;
FIG. 2 is a top view of the adhesive bandage with decorated pad depicted in FIG. 1;
FIG. 3 is a left side view of the adhesive bandage with decorated pad depicted in FIG. 1;
FIG. 4 is a bottom view of the adhesive bandage with decorated pad depicted in FIG. 1;
FIG. 5 is a right side view of the adhesive bandage with decorated pad depicted in FIG. 1;
FIG. 6 is a front side view of the adhesive bandage with decorated pad depicted in FIG. 1;
FIG. 7 is a back side view of the adhesive bandage with decorated pad depicted in FIG. 1;
FIG. 8 is a top perspective view of a second embodiment of the present invention;
FIG. 9 is a top view of the adhesive bandage with decorated pad depicted in FIG. 8;
FIG. 10 is a left side view of the adhesive bandage with decorated pad depicted in FIG. 8;
FIG. 11 is a bottom view of the adhesive bandage with decorated pad depicted in FIG. 8;
FIG. 12 is a right side view of the adhesive bandage with decorated pad depicted in FIG. 8;
FIG. 13 is a front side view of the adhesive bandage with decorated pad depicted in FIG. 8;
FIG. 14 is a back side view of the adhesive bandage with decorated pad depicted in FIG. 8;
FIG. 15 is a top perspective view of a third embodiment of the present invention;
FIG. 16 is a top view of the adhesive bandage with decorated pad depicted in FIG. 15;
FIG. 17 is a left side view of the adhesive bandage with decorated pad depicted in FIG. 15;
FIG. 18 is a bottom view of the adhesive bandage with decorated pad depicted in FIG. 15;
FIG. 19 is a right side view of the adhesive bandage with decorated pad depicted in FIG. 15;
FIG. 20 is a front side view of the adhesive bandage with decorated pad depicted in FIG. 15;
FIG. 21 is a back side view of the adhesive bandage with decorated pad depicted in FIG. 15;
FIG. 22 is a top perspective view of a fourth embodiment of the present invention;
FIG. 23 is a top view of the adhesive bandage with decorated pad depicted in FIG. 22;
FIG. 24 is a left side view of the adhesive bandage with decorated pad depicted in FIG. 22;
FIG. 25 is a bottom view of the adhesive bandage with decorated pad depicted in FIG. 22;
FIG. 26 is a right side view of the adhesive bandage with decorated pad depicted in FIG. 22;
FIG. 27 is a front side view of the adhesive bandage with decorated pad depicted in FIG. 22;
FIG. 28 is a back side view of the adhesive bandage with decorated pad depicted in FIG. 22;
FIG. 29 is a top perspective view of a fifth embodiment of the present invention;
FIG. 30 is a top view of the adhesive bandage with decorated pad depicted in FIG. 29;
FIG. 31 is a left side view of the adhesive bandage with decorated pad depicted in FIG. 29;
FIG. 32 is a bottom view of the adhesive bandage with decorated pad depicted in FIG. 29;
FIG. 33 is a right side view of the adhesive bandage with decorated pad depicted in FIG. 29;
FIG. 34 is a front side view of the adhesive bandage with decorated pad depicted in FIG. 29;
FIG. 35 is a back side view of the adhesive bandage with decorated pad depicted in FIG. 29;
FIG. 36 is a top perspective view of a sixth embodiment of the present invention;
FIG. 37 is a top view of the adhesive bandage with decorated pad depicted in FIG. 36;
FIG. 38 is a left side view of the adhesive bandage with decorated pad depicted in FIG. 37;
FIG. 39 is a bottom view of the adhesive bandage with decorated pad depicted in FIG. 38;
FIG. 40 is a right side view of the adhesive bandage with decorated pad depicted in FIG. 39;
FIG. 41 is a front side view of the adhesive bandage with decorated pad depicted in FIG. 40; and,
FIG. 42 is a back side view of the adhesive bandage with decorated pad depicted in FIG. 41.
The ornamental design which is claimed is shown in solid lines in the drawings.
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29725583
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johnson & johnson consumer inc.
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USA
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S1
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Design Patent
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Open
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D24/189
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15
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Apr 27th, 2022 09:14AM
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Apr 27th, 2022 09:14AM
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Johnson & Johnson
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Health Care
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Pharmaceuticals & Biotechnology
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nyse:jnj
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Johnson & Johnson
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Apr 26th, 2022 12:00AM
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Feb 13th, 2020 12:00AM
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https://www.uspto.gov?id=US11311510-20220426
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Esters for treatment of ocular inflammatory conditions
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The present invention relates to ophthalmic compositions and methods for the treatment of dry eye and other inflammatory ocular conditions. In particular, the present invention relates to a composition comprising an esterified anti-inflammatory lipid mediator, which is an ester of an anti-inflammatory lipid mediator that is a reaction product of the anti-inflammatory lipid mediator and a polyol wherein the majority of the anti-inflammatory lipid mediator is present in an ester form. In this way, the compositions are substantially free of an acid form of the anti-inflammatory lipid mediators. Anti-inflammatory lipid mediators can be selected from the group consisting of polyunsaturated fatty acids (e.g., omega-three and omega-six fatty acids), resolvins or a metabolically stable analog, protectins or a metabolically stable analog, lipoxins or a metabolically stable analog, prostaglandins or a metabolically stable analog, retinoic acids, endocannabinoids, metabolites thereof, and mixtures thereof. This composition can be topically delivered to the ocular surface via a preparation, solution, gel, ointment, and/or strip and/or a contact lens.
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11311510
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1. An ophthalmic composition for treatment of ocular conditions, the ophthalmic composition comprising
an ester of an anti-inflammatory lipid mediator comprising eicosapentaenoic acid inositol ester; and an aqueous delivery system;
wherein the ophthalmic composition is suitable for administration to the eye or ocular environment and is substantially free from an acid form of the anti-inflammatory lipid mediator.
2. The composition of claim 1, wherein the ester is present in a therapeutically effective amount.
3. The composition of claim 1, wherein the composition is substantially free of fatty acids.
4. The composition of claim 1, wherein the composition comprises 10% by weight or less of the acid form of the anti-inflammatory lipid mediator.
5. The composition of claim 4, wherein the composition comprises 5% by weight or less of the acid form of the anti-inflammatory lipid mediator.
6. The composition of claim 5, wherein the composition comprises 1% by weight or less of the acid form of the anti-inflammatory lipid mediator.
7. The composition of claim 1, wherein the ester is present in an amount in the range of about 0.01% to 5.0% by weight, based on the total composition.
8. The composition of claim 7, wherein the ester is present in an amount in the range of about 0.025% to 0.5% by weight, based on the total composition.
9. The composition of claim 1, wherein the aqueous delivery system comprises one or more of the following: a surfactant, an emulsifier, a wetting agent, a chelant, and an antioxidant.
10. The composition of claim 1, wherein the aqueous delivery system comprises one or more ingredients selected from the group consisting of polysorbate 80™, Tyloxapol™, methyl gluceth-20, Vitamin E, diethylenetriaminepentaacetic acid, boric acid, sodium borate, and sodium chloride.
11. A sterile preparation, solution, gel, ointment, emulsion or strip for administration to the eye or a contact lens comprising the composition of claim 1.
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11
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RELATED APPLICATIONS
This application is a Continuation application of Ser. No. 14/466,137, filed Aug. 22, 2014, which is a Divisional application of U.S. patent application Ser. No. 13/495,052, filed Jun. 13, 2012, now U.S. Pat. No. 8,865,685 Issued Oct. 21, 2014, which claims priority to U.S. Provisional Patent Application Ser. No. 61/503,158, filed on Jun. 30, 2011.
TECHNICAL FIELD
The present invention relates to ocular products containing esterified anti-inflammatory lipid mediators for relief of dry eye or treatment of inflammatory ocular conditions. Provided is an ophthalmic composition that comprises an esterified anti-inflammatory lipid mediator. Further provided are sterile preparations, solutions, gels, ointments, and/or strips for administration to the eye and/or a contact lens that comprises an esterified anti-inflammatory lipid mediator.
BACKGROUND
It is known that sufficient lubrication is necessary for good eye health. Tears nourish the ocular tissues and protect the surface of the eye from foreign bodies. Changes in the ocular surface due to alterations in the quality or quantity of tears (caused by either decreased tear production or increased tear film evaporation) can lead to dry eye syndrome and other inflammatory ocular conditions. Typical symptoms of dry eye and other inflammatory ocular conditions include dryness, burning, itchiness, scratchiness, stinging, a sandy/gritty sensation, tired eyes, and sensitivity to light. These symptoms typically worsen as the day progresses. Other symptoms include pain, redness, a pulling sensation, pressure behind the eye, and a feeling that there is something in the eye. Because of the range of symptoms, individuals suffering from dry eye and other inflammatory ocular conditions often complain of eye irritation and discomfort.
If dry eye and other inflammatory ocular conditions are left untreated, it can produce complications that can cause eye damage, resulting in impaired vision or (rarely) the loss of vision. When symptoms are severe, they can interfere with the quality of life of an individual suffering from dry eye.
The ocular surface is normally covered by a tear film—the clear liquid that coats the outer tissues of the eye. The tear film is composed of three layers; the most superficial layer of the tear film is the lipid layer, which covers the aqueous layer of the tear film, and then the third layer is a mucinous layer. Any abnormality in any one of the three layers, particularly a disturbance in the lipid layer, produces an unstable tear film, which results in symptoms of dry eye and other inflammatory ocular conditions.
Current methods of alleviating the symptoms of dry eye include administering artificial tears to the ocular surface. These artificial tears, however, must be administered every few hours, and only provide temporary and incomplete relief of the symptoms of dry eye. Thus, there is a need for compositions and methods to treat various eye disorders and conditions, including but not limited to, dry eye syndrome and other inflammatory ocular conditions.
It has been noted that consumption of dark fleshed fish containing dietary omega-three fatty acids is associated with a decreased incidence of dry eye symptoms. Omega-three and omega-six fatty acids are compounds known as “essential” fatty acids because they are essential to human health. These fatty acids, however, are not produced by the human body; instead, the fatty acids can be introduced into the body via dietary intake, either in the form of food or as supplements. Oral consumption of omega-three fatty acids, however, does produce potential side effects such as effects on bleeding time, increasing cholesterol (LDL) level, high caloric intake, a fishy aftertaste, and gastrointestinal disturbances. Because of their potential to improve the symptoms of dry eye and other inflammatory ocular conditions, work on omega-three fatty acids when used in a topical application to the ocular surface has shown promising results. (Rashid, S. et al., “Topical Omega-3 and Omega-6 Fatty Acids for Treatment of Dry Eye,” Arch Opthalmol. 2008; 126(2):219-225). Using topical formulations of fatty acids to treat dry eye would provide more flexibility for treatment, including lessening side-effects that patients can experience from oral intake of fatty acids.
Omega-three fatty acid-containing oils such as botanical oils have been used to form non-irritating ophthalmic compositions (e.g., U.S. Patent Application Pub. 2010/0305045 (Abbott Medical Optics, Inc.)). Hydrogel contact lenses can comprise a polymeric matrix and a hydrophobic comfort agent distributed in the polymeric matrix, where the hydrophobic comfort agent can include a monoglyceride, a diglyceride, a triglyceride, a glycolipid, a glyceroglycolipid, a sphingolipid, a sphingoglycolipid, a phospholipid, a fatty acid, a fatty alcohol, a hydrocarbon having a C12-C28 chain in length, a mineral oil, a silicone oil, or a mixture thereof. (U.S. Patent Application Pub. 2010/0140114 (Ciba Vision Corporation)). Ophthalmic lenses have been provided with anti-toxin agents that are monoesters and/or diesters of a polyhydric aliphatic alcohol and a fatty acid containing from eight to eighteen carbon atoms and wherein said monoester has at least one hydroxyl group associated with its aliphatic alcohol residue (U.S. Pat. No. 5,472,703). Resolvins and protectins have been used to help treat pathologies associated with angiogenesis and ocular neovascularization, particularly associated with retinopathy of prematurity (e.g., U.S. Patent Application Pub. 20100105773 (Children's Medical Center Corp.)). Lipoxins have also been used to treat pathologies associated with ocular neovascularization (e.g., U.S. Patent Application Pub. 20100105772 (Serhan, et. al.)).
Accordingly, there remains a need in the art for improved ocular products that relieve/mediate symptoms of dry eye and other inflammatory ocular conditions.
SUMMARY
In one embodiment, the present invention provides an ophthalmic composition for treatment of ocular conditions, the composition comprising an ester or amide of an anti-inflammatory lipid mediator that is a reaction product of the anti-inflammatory lipid mediator and a polyol having a carbon chain length of four to ten carbons. Generally, the majority of the anti-inflammatory lipid mediator is present in an ester form. This is in contrast to anti-inflammatory lipid mediators being present in an acid form. In one or more embodiments, the composition is substantially free of fatty acids. Such an esterified anti-inflammatory lipid mediator can be dispersible and/or dissolvable or emulsifiable in an aqueous delivery system.
In another embodiment, the present invention provides a sterile preparation, solution, gel, ointment, emulsion or strip for administration to the eye or a contact lens comprising an esterified anti-inflammatory lipid mediator.
In a further embodiment, the present invention provides a method of treating, preventing or mitigating inflammatory ocular conditions and/or dry-eye in an individual in need thereof which comprises delivering to such individual's ocular surface a therapeutically effective amount of a composition comprising an anti-inflammatory lipid mediator.
These and other embodiments of the invention will become apparent from the following description of the presently preferred embodiments. The detailed description is merely illustrative of the invention and does not limit the scope of the invention, which is defined by the claims and equivalents thereof. Variations and modifications of the invention may be effected without departing from the spirit and scope of the novel contents of the disclosure.
DETAILED DESCRIPTION
Provided are processes of making and using ocular products containing esterified anti-inflammatory lipid mediators, wherein the majority of the anti-inflammatory lipid mediator is present in an ester form. It has been discovered that the use of esterified anti-inflammatory lipid mediators, when the majority of the anti-inflammatory lipid mediator is present in the ester form, results in an ocular product that greatly improves initial comfort upon contact with or administration to the ocular surface. Ocular products include, but are not limited to, preparations, solutions, gels, ointments, emulsions, strips, ophthalmic devices, and the like any which can be administered to the ocular surface, including the eye.
With respect to terms used in this disclosure, the following definitions are provided.
Reference to “anti-inflammatory lipid mediator” includes those molecules that play a role (directly or indirectly) in the inhibition of cytokine production by epithelial cells or immune cells, in the inhibition of reactive oxygen species (ROS) production by epithelial cells or immune cells, in the control and/or inhibition of recruitment of white blood cells (reduction in leukocytes infiltration), and/or in the resolution of inflammation (promotion of uptake of dead cells). Suitable anti-inflammatory lipid mediators are generally acid-based entities whose carboxylic groups of the hydrocarbon chain can be esterified. The majority of the anti-inflammatory lipid mediator is present in the ester form. Anti-inflammatory lipid mediators can be reacted with hydroxyl groups of various entities as desired. The hydroxyl groups are delivered by polyols that can provide therapeutic benefits to the eye, including osmoprotection, in conjunction with the esterified anti-inflammatory lipid mediators.
As used herein, the term “about” refers to a range of +/−5% of the number that is being modified. For example, the phrase “about 10” would include both 9.5 and 10.5.
As used herein, the use of “a,” “an,” and “the” includes the singular and plural.
As used herein, the term “ophthalmic composition” refers to a compound or mixture suitable for administration to the eye or ocular surface. Ocular compositions include preparations, solutions, gels, ointments, emulsions, strips and the like.
As used herein the term “sterile preparation” includes any compound or mixture for direct administration to any part of a mammalian body, including implantation, injection, administration as a drop, gel or wash, and the like, wherein the preparation is substantially free from undesired foreign matter just prior to administration. Methods for insuring sterility include aseptic packaging and sterilization by exposure to radiation, heat combinations thereof and the like.
As used herein, the term “individual” includes humans and vertebrates.
As used herein, the term “agent” includes any compound, composition, to be tested for efficacy in the methods disclosed herein.
As used herein the term “ocular surface” includes the wet-surfaced and glandular epithelia of the cornea, conjunctiva, lacrimal gland, accessory lacrimal glands, nasolacrimal duct and meibomian gland, and their apical and basal matrices, puncta and adjacent or related structures, including the eyelids linked as a functional system by both continuity of epithelia, by innervation, and the endocrine and immune systems.
As used herein, the term “contact lens” refers to a structure that can be placed on the cornea of an individual's eye. The contact lens may provide corrective, cosmetic, therapeutic benefit, including wound healing, delivery of drugs or neutraceuticals, diagnostic evaluation or monitoring, or UV blocking and visible light or glare reduction, or a combination thereof. A contact lens can be of any appropriate material known in the art, and can be a soft lens, a hard lens, or a hybrid lens.
As used herein, the term “silicone hydrogel contact lens” refers to a contact lens formed from a polymer comprising silicone containing and hydrophilic repeating units.
As used herein, the term “hydrogel” or “hydrogel material” refers to a hydrated crosslinked polymeric system that contains water in an equilibrium state. Hydrogels generally contain at least about 15 wt % water, and in some embodiments at least about 20 wt % water at equilibrium.
Conventional hydrogels are prepared from monomeric mixtures predominantly containing hydrophilic monomers, such as 2-hydroxyethyl methacrylate (“HEMA”), N-vinyl pyrrolidone (“NVP”), or vinyl acetate. U.S. Pat. Nos. 4,495,313, 4,889,664, and 5,039459 disclose the formation of conventional hydrogels.
As used herein, the term “silicone hydrogel” refers to a hydrogel obtained by copolymerization of at least one silicone-containing monomer, macromer, prepolymer, with at least one hydrophilic component. Examples of silicone hydrogels include balafilcon, acquafilcon, lotrafilcon, comfilcon, galyfilcon, senofilcon, narafilcon, falcon II 3, asmofilcon A, as well as silicone hydrogels as prepared in U.S. Pat. No. 5,998,498, WO 03/22321, U.S. Pat. Nos. 6,087,415, 5,760,100, 5,776,999, 5,789,461, 5,849,811, 5,965,631, 7,553,880, WO 2008/061992, and U.S. 2010/048847. These patents, as well as all other patents disclosed in this paragraph, are hereby incorporated by reference in their entireties.
Hard contact lenses are made from polymers that include but are not limited to polymers of poly(methyl)methacrylate, silicon acrylates, fluoroacrylates, fluoroethers, polyacetylenes, and polyimides, where the preparation of representative examples may be found in JP 200010055, JP 6123860 and U.S. Pat. No. 4,330,383. Intraocular lenses of the invention can be formed using known materials. For example, the lenses may be made from a rigid material including, without limitation, polymethyl methacrylate, polystyrene, polycarbonate, or the like, and combinations thereof. Additionally, flexible materials may be used including, without limitation, hydrogels, silicone materials, acrylic materials, fluorocarbon materials and the like, or combinations thereof. Typical intraocular lenses are described in WO 0026698, WO 0022460, WO 9929750, WO 9927978, WO 0022459, and JP 2000107277. All of the references mentioned in this application are hereby incorporated by reference in their entireties.
A therapeutically effective amount of an anti-inflammatory lipid mediator is an amount effective to produce a clinically recognizable favorable change in the pathology of the disease or condition being treated. A therapeutically effective amount includes those effective to treat, reduce, alleviate, ameliorate, mitigate, eliminate or prevent one or more symptoms of the ocular conditions sought to be treated or the condition sought to be avoided or treated.
One of skill in the art would readily be able to determine what is a therapeutically effective amount or an effective amount.
As used herein, the term “inflammatory ocular condition” includes dry eye syndromes, which is also called keratoconjunctivitissicca (KCS). Dry eye is a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. It is accompanied by increased osmolarity of the tear film and inflammation of the ocular surface. Dry Eye Syndrome (DES) is defined as a disorder of the tear film, resulting from tear deficiency and/or excessive tear evaporation, causing damage to the ocular surface and causing symptoms of ocular discomfort. There are two main forms of dry eye syndrome: tear deficiency forms (including Sjögren's syndrome and non-Sjögren's tear deficient) and evaporative forms. The tear film normally covers the front part of the eye, namely the cornea and the conjunctiva. The tear film is constantly exposed to multiple environmental factors, including variable temperature, airflow, and humidity, which may stimulate or retard its evaporation. In particular, a low humidity setting in the presence of a significant airflow increases the tear evaporation rate, as is frequently reported by subjects in desiccating environments. Indeed, even people with a normal tear secretion rate may experience dry eye symptoms while exposed to dry environments, such as in airplanes and dry workplaces.
Dry eye can also be defined as a condition with a decrease or change in quality of tears irrespective of the presence or absence of corneal and conjunctival lesions. It includes dry eye conditions found in individuals who have hypolacrimation, alacrima, xerophthalmia, and diabetes, HIV/AIDS etc.; post-cataract surgery dry eye; allergic conjunctivitis-associated dry eye; dry-eye associated with prolonged contact lens use; and age-related dry-eye syndrome. Dry eye can also include the conditions found in hypolacrimation individuals induced by long time visual display terminal (VDT) operations, room dryness due to air-conditioning, and the like. An “inflammatory ocular condition” can also refer to, but is not limited to: keratoconjunctivitissicca (KCS), age-related dry eye, Stevens-Johnson syndrome, Sjögren's syndrome, ocular cicatricalpemphigoid, blepharitis, corneal injury, infection, Riley-Day syndrome, congenital alacrima, nutritional disorders or deficiencies (including vitamin), pharmacologic side effects, eye stress, glandular and tissue destruction, environmental exposure (e.g. smog, smoke, excessively dry air, airborne particulates), autoimmune and other immunodeficient disorders, and comatose individuals rendered unable to blink.
As used herein “contact lens related dry eye” (“CLRDE”) is a disorder marked by at least one objective clinical symptom and at least one subjective symptom. Clinical symptoms are selected from (a) a tear film break up time (“TFBUT”) of less than about 10 seconds in at least one eye; (b) a fluorescein staining score ≥3 on a scale of 0-15 in at least one eye; (c) a lissamine green staining score ≥3 on a scale of 0-18 in at least one eye; or (d) a tear meniscus grade of ‘abnormal’ in at least one eye. Subjective symptoms are determined via patient feedback and include (a) ≥about 2-hour difference between average daily contact lens wear time and average daily comfortable contact lens wear time and (b) a rating of frequent or constant feelings of dryness, burning, stinging or discomfort during lens wear. CLRDE sign includes both excessive tear evaporation and Non-Sjogren's aqueous tear deficiency. Excessive tear evaporation is a disorder marked by a TFBUT of about 10 seconds or less in at least one eye or a TFBUT of 10 seconds or less in at least one eye as well as conjunctival or corneal staining of about 3 or greater on the NEI scale. Non-Sjogren's aqueous tear deficiency tear meniscus is a disorder marked by a grade of ‘abnormal’ in at least one eye or a tear meniscus grade of ‘abnormal’ in at least one eye as well as conjunctival or corneal staining of 3 or greater on the NEI scale.
As used herein the term “adnexal inflammation” includes inflammation of any area or part of the eye or ocular system, including but not limited to the eyelids, the lacrimal glands and extraocular muscles.
As used herein, there term “osmoprotection” means to maintain an ophthalmic osmolarity within a normal physiological range (preferably 270-320 mOsm/kg, with an average of about 290 mOsm/kg) and/or protect epithelial tissue against the effects of hypertonic conditions, where the unit “mOsm/kg” is milli-osmole per kilogram. Osmoprotectants, agents that offer osmoprotection, are generally uncharged, can be held within an ocular cell, are of relatively small molecular weight, and are otherwise compatible with cell metabolism. Osmoprotectants protect against hypertonicity below the ocular surface and provide hydration to the epithelial surface. Osmoprotectants include, without limitation, glycerol, inositol, sorbitol, xylitol, and erythritol.
As used herein, the term “unsaturated fatty acid” refers to a fatty acid containing at least one double or triple bond. Fatty acids in this class use the Greek alphabet to identify the location of double bonds. The “alpha” carbon is the carbon closest to the carboxyl group and the “omega” carbon is the last carbon of the chain. For example, linoleic acid, and gamma-linolenic acid (LA and GLA respectively) are omega-six fatty acids, because they have double bonds six carbons away from the omega carbon. Alpha-linolenic acid is an omega-three fatty acid because it has a double bond three carbon atoms from the omega carbon.
As used herein, the term “omega-three fatty acid” refers to fatty acids that have double bonds three carbon atoms from their omega carbon atom. For example, an omega-three fatty acid includes, but is not limited to alpha linolenic acid (ALA). Other omega-three fatty acids include derivatives of ALA. A “derivative” of ALA is a fatty acid that is made by a chemical modification performed upon alpha linolenic acid by, for example, an enzyme or is done by organic synthesis. Examples of omega-three fatty acids that are derivatives of ALA, include but are not limited to, eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), and the like. An “omega-three fatty acid” can comprise one or more omega-three fatty acids.
As used herein, the term “omega-six fatty acid” refers to one or more fatty acids that have a double bond 6 carbon atoms from their omega carbon atoms. For example, an omega-six fatty acid includes, but is not limited to linoleic acid (LA). Other omega-six fatty acids include derivatives of linolenic acid. A “derivative” of linoleic acid is a fatty acid that is made by a chemical modification performed upon linoleic acid. Examples of omega-six fatty acids that are derivatives of linoleic acid include, but are not limited to, gamma linolenic acid (GLA), dihomogammalinolenic acid (DGLA), and the like. In some embodiments, the composition comprises at least one non-inflammatory omega-six fatty acid. A non-inflammatory omega-six fatty acid is an omega-six fatty acid that does not promote or cause inflammation. In some embodiments the inflammation is in the eye or affects the ocular surface. One of skill in the art can determine if a fatty acid causes or promotes inflammation. If the fatty acid causes or promotes inflammation, the fatty acid can be excluded from the composition.
As used herein the term “linoleic acid” refers to 9,12-octadecandienoic acid, which has a short hand designation of 18:2(n-6), which is number of carbons:number double bonds (position). Throughout the specification linoleic acid is referred to as either linoleic acid or “LA”.
As used herein the term “arachidonic acid” refers to 5, 8, 11, 14 eicosatetraenoic acid, which has a short hand designation of 20:4(n-6) and a molecular weight of 304.5. Throughout the specification arachidonic acid is referred to as either arachidonic acid or “AA”. It should be noted that arachidonic acid can yield pro-inflammatory prostaglandins. It also should be noted that arachidonic acid can be involved in enzymatic processes that result in beneficial anti-inflammatory lipid mediators such as lipoxins and an endocannabinoid that is anandamide (arachidonoylethanolamine).
As used herein the term “alpha-linolenic acid” refers to 9, 12, 15 octadecatrienoic acid, which has a short hand designation of 18:3(n-3) and a molecular weight of 278.4. Throughout the specification alpha-linolenic acid is referred to as either alpha-linolenic acid or “ALA”.
As used herein the term “gamma-linolenic acid” refers to 9, 6, 12-octadecatrienoic acid, which has a short hand designation of 18:3(n-6) and a molecular weight of 278.4. Throughout the specification gamma-linolenic acid is referred to as either gamma-linolenic acid or “GLA”.
As used herein the term “dihomogamma-linolenic acid” refers to 8, 11, 14 eicosatrienoic acid, which has a short hand designation of 20:3(n-6) and a molecular weight of 306.5. Throughout the specification eicosatrienoic acid is referred to as either eicosatrienoic acid or “DGLA”.
As used herein the term “eicosapentaenoic acid” refers to 5,8,11,14,17-eicosapentaenoic acid, which has a short hand designation of 20:5(n-3) and a molecular weight of 302.5. Throughout the specification eicosapentaenoic acid is referred to as either eicosapentaenoic acid or “EPA”.
As used herein the term “docosahexaenoic acid” refers to 4,7,10,13,16,19-docosahexaenoic acid, which has a short hand designation of 22:6(n-3) and a molecular weight of 328.6. Throughout the specification docosahexaenoic acid is referred to as either docosahexaenoic acid or “DHA”.
As used herein, the term “ester” refers to any chemical compound derived by reaction of an oxoacid (an organic acid that contains oxygen) with a hydroxyl compound, such as an alcohol. Esters are usually derived from an organic acid in which at least one hydroxyl (—OH) group is replaced by an —O-alkyl (alkoxy) group. Most commonly, esters are formed by condensing a carboxylic acid with an alcohol. In one or more embodiments, the esters of the present invention can be naturally occurring, or can be formed by reaction of a fatty acid with an alcohol.
As used herein, the term “amidoester” refers to any chemical compound derived by reaction of an oxoacid with an amine. One or more embodiments provide that the reaction of a fatty acid with an amine provides an amidoester. Reference to the “ester form” can include the amidoester in addition to the traditional ester. Reference to “reaction product” means a resulting ester or amidoester that is formed by reaction of an acid with an alcohol or amine, regardless of whether the ester or amidoester is naturally-occurring or synthesized. If synthesized, the ester or amidoester can be prepared by various esterification methods known to one skilled in the art.
As used herein, the term “wax ester” refers to an ester of a fatty acid and a long-chain alcohol. Wax esters include, without limitation, beeswax and carnauba wax. Beeswax consists of C40 to C46 molecular species. Carnauba wax constitutes from C16 to C20 fatty acids esterified with C30 to C34 long-chain alcohols to provide a C46 to C54 molecular species.
As used herein, the term “alcohol” refers to any organic compound containing at least one hydroxyl functional group (—OH) bound to a carbon atom, that is usually bound to other carbon and hydrogen atoms; this includes, but is not limited to, acyclic alcohols; cyclic alcohols; primary, secondary, and tertiary alcohols; monohydric alcohols and polyols. The alcohols of the present invention include polyhydric alcohols or polyols, which are alcohols that include at least two hydroxyl functional groups and 4-10 carbon atoms and in some embodiments 4-8 carbon atoms, and in others 5-8 carbon atoms. In other embodiments, alcohols include polyols that provide osmoprotection, including, but not limited to, polyethylene glycol, polyvinyl alcohol, inositol, sorbitol, xylitol, and erythritol.
As used herein, the term “resolvin” is an agent that is generated from the interaction between an omega-three polyunsaturated fatty acid such as eicosapentaenoic acid (EPA) or docosahexaenoic acid (DHA), cyclooxygenase-II (COX-2) and an analgesic, such as aspirin. Resolvins of the E series are derived from EPA, whereas resolvins of the D series are derived from DHA. Exemplary resolvins include resolvin E1 (RvE1), resolvin E2 (RvE2), resolvin D1 (RvD1), resolvin D2 (RvD2), resolvin D3 (RvD3), resolvin D4 (RvD4), and combinations thereof.
As used herein, the term “protectin” or “neuroprotectin” is an agent, more particularly, a docosanoid (which is a signaling molecule made by oxygenation of 22-carbon essential fatty acids, especially DHA), that is derived from the polyunsaturated fatty acid docosahexaenoic acid (DHA). A “protectin” or “neuroprotectin” exerts potent anti-inflammatory and anti-apoptotic bioactivity at nanomolar concentrations in a variety of experimental models of brain and retinal diseases. An exemplary protectin includes protectin D1 (PD1).
As used herein, the term “lipoxin” refers to a series of anti-inflammatory lipid mediators that are synthesized by the 5-lipoxygenase pathway. Lipoxins are short-lived, endogenously produced, non-classic tetraene-containing eicosanoids, whose appearance in inflammation signals the resolution of inflammation. Lipoxins are also derived enzymatically from arachidonic acid, an omega-six fatty acid. Exemplary lipoxins include lipoxin A4 (LXA), lipoxin B4 (LXB4), and combinations thereof.
As used herein, the term “prostaglandin” refers to one of a number of hormone-like substances that participate in a wide range of body functions such as the contraction and relaxation of smooth muscle, the dilation and constriction of blood vessels, control of blood pressure, and modulation of inflammation. Prostaglandins are derived from omega-three and omega-six fatty acids acid. There are three main types of prostaglandins: Prostaglandin E1 (PGE1) and prostaglandin E3 (PGE3), which have anti-inflammatory properties, and prostaglandin E2 (PGE2), which promotes inflammation. PGE1, derived from dihomo-gamma-linolenic acid, is a potent vasodilator agent that increases peripheral blood flow, inhibits platelet aggregation, and has many other biological effects such as bronchodilation, and mediation of inflammation. PGE1 is important for lacrimal and salivary gland secretion and for T cell function. PGE2, derived from arachidonic acid, is released by blood vessel walls in response to infection or inflammation and acts on the brain to induce fever; PGE2 has also been used extensively as an oxytocic agent. PGE3, is formed via the cyclooxygenase (COX) metabolism of eicosapentaenoic acid. It is known that PGE3 lowers intraocular pressure.
As used herein, the term “retinoic acid” refers to a metabolite of Vitamin A (retinol) that mediates the functions of Vitamin A required for growth and development. Retinoic acids have been shown to have strong anti-inflammatory properties, in addition to their function as sebostaticums. (see Plewig, G., et al., Archives of Dermatological Research, Vol. 270, No. 1, 89-94). Retinoic acids can include, without limitation, 13-cis-retinoic acid.
As used herein, the term “endocannabinoid” refers to a class of organic compounds found produced within the body that activate cannabinoid receptors. Endogenous cannabinoids (“endocannabinoids”), when present in tissues at elevated concentrations, provide anti-inflammatory and analgesic effects. Endocannabinoids serve as intercellular lipid messengers, signaling molecules that are released from one cell and activating the cannabinoid receptors present on other nearby cells; they use retrograde signaling. Endocannabinoids are lipophilic molecules that are not very soluble in water. Endocannabinoids can include, without limitation, anandamide (arachidonoylethanolamine) and 2-arachidonoylglycerol.
As used herein, the term “phospholipid” refers to any of various phosphorous-containing lipids that are composed mainly of fatty acids, a phosphate group, and a simple organic molecule such as choline. Preferably, the phospholipids contain residues of one or more fatty acids that are omega-3 fatty acids, along with, as desired, omega-6 fatty acids. Phospholipids are amphipathic in nature; that is, the polar end of a phospholipid is soluble in water (hydrophilic) and aqueous solutions, while, the fatty acid end is soluble in fats (hydrophobic). In an aqueous environment, phospholipids combine to form a two-layer structure (lipid bilayer) with the hydrophobic ends in the middle and the hydrophilic ends exposed to the aqueous environment. Such lipid bilayers are the structural basis of cell membranes.
As used herein, the term “metabolite” refers to a compound that is the product of metabolism. A metabolite is formed as part of the natural biochemical process of degrading and eliminating compounds.
As used herein, the term “metabolically stable analog” refers to a compound that is a structural derivative of a parent compound (sometimes differing from the parent compound by a single element) or is a compound with similar properties to the parent compound. The analog is not easily degraded, and, thus, is metabolically stable.
As used herein the term “CD11b+ infiltration” includes the increase in CD11b+ cells present in the center and periphery of the cornea following dry eye induction.
As used herein the term “IL-1α or TNF-α expression” includes measuring RNA transcripts of IL-1α and TNF-α by quantitative real-time Polymerase Chain Reaction.
As used herein the term “inflammatory cytokines” includes, without limitation, IL-1α and TNF-α.
Turning to the details of the disclosure, provided are processes of making and using ocular products containing esterified anti-inflammatory lipid mediators, wherein the majority of the anti-inflammatory lipid mediator is present in an ester form. One or more embodiments provide that the compositions are substantially free of fatty acids. That is, in such embodiments, the ocular products contain 10% by weight or less (or 8%, or 6%, or 5%, or 4%, or 3%, or 2%, or even 1%) of the acid form of the anti-inflammatory lipid mediator. In a further embodiment, the ocular products contain 1% by weight or less (or 0.8%, or 0.6%, or 0.5%, or 0.4%, or 0.3%, or 0.2%, or even 0.1%, or 0.05%, or 0.025%, or 0.01%) of the acid form of the anti-inflammatory lipid mediator. The esterified anti-inflammatory lipid mediators are esters of an acid anti-inflammatory lipid mediator. The esters may be formed by reacting the anti-inflammatory lipid mediator with at least one polyol having a carbon chain length of four to ten. Desirable anti-inflammatory lipid mediators include omega-three and/or omega-six fatty acids, resolvins or a metabolically stable analog, protectins or a metabolically stable analog, lipoxins or a metabolically stable analog, prostaglandins or a metabolically stable analog, retinoic acids, endocannabinoids, and phospholipids. Inflammation is a component of dry eye. There is a need to deliver active candidates, known to mitigate inflammation, in forms that are not associated with initial discomfort (acute ocular discomfort) upon administration to the eye, while providing long-term benefits to the eye.
One or more embodiments provide that the ester is provided in a therapeutically effective amount. That is, the ester is present in an amount sufficient to provide a beneficial effect to the ocular area, including but not limited to the ocular surface, the back of the eye, tear formation and stability. A therapeutically effective amount of ester can deliver an appropriate amount of anti-inflammatory lipid mediator that imparts a benefit to the ocular environment.
In the free fatty acid formulations (for example, alpha-linolenic acid emulsions) of the prior art (e.g., those compositions disclosed in U.S. Patent Application Pub. 20070265341 (Dana et al.)), discomfort upon instillation to the eye has been found. A change in the concentration of surfactants (mostly Tween-80, from 2.5% to 0.25%) or the use of additional surfactant(s) (such as the amphoteric monateric surfactant) did not result in improved comfort upon instillation. The current invention seeks to avoid or remedy the discomfort issue by making the essential fatty acid non-ionic, i.e., using the esterified counterpart of the molecule.
Anti-inflammatory lipid mediators, such as polyunsaturated fatty acids, resolvins or a metabolically stable analog, protectins or a metabolically stable analog, lipoxins or a metabolically stable analog, prostaglandins or a metabolically stable analog, retinoic acids, endocannabinoids, and phospholipids are desirable ingredients of ocular products for use in treating such ocular conditions as inflammation, dry eye and/or dryness symptoms, and meibomian gland dysfunction. It has been discovered that the use of esterified anti-inflammatory lipid mediators, when the majority of the anti-inflammatory lipid mediator is present in the ester form, results in an ocular product that greatly improves initial comfort upon contact with or administration to the ocular surface. Generally, the esterified anti-inflammatory lipid mediator is a reaction product of an acid anti-inflammatory lipid mediator and an alcohol or an amine.
Such esterified anti-inflammatory lipid mediators may also be useful in a rewetting drop, in some instances unpreserved, or may be associated with a contact lens, such as a silicone hydrogel, whereby the lens may be treated with a mixture of the esterified anti-inflammatory lipid mediators. The esterified anti-inflammatory lipid mediators can be incorporated into the contact lens using various methods, for example, incorporation can occur during the lens extraction or hydration process or a combination thereof.
Such a characteristic is not offered by previous uses of fatty acids and/or fatty acid oils. The esterified anti-inflammatory lipid mediators can be combined with an aqueous delivery system—for desired ophthalmic compositions.
Esterified anti-inflammatory lipid mediators, when the majority of the anti-inflammatory lipid mediator is present in the ester form, have the advantage of targeting the inflammatory component of the dry eye disease (which perpetuates dry eye disease) and are less likely to cause initial discomfort at a wider concentration range. Upon contact with and uptake to the cells of the ocular surface, and without intending to be bound by theory, it is thought that esterified anti-inflammatory lipid mediators, such as esterified polyunsaturated fatty acids, esterified resolvins or a metabolically stable analog, esterified protectins or a metabolically stable analog, esterified lipoxins or a metabolically stable analog, esterified prostaglandins or a metabolically stable analog, esterified retinoic acids, endocannabinoids, and phospholipids, undergo hydrolysis and return to their acidic anti-inflammatory lipid mediator state along with the alcohol that was used in forming the ester.
Turning to the esters of polyunsaturated fatty acids such as omega-three and omega-six fatty acids, the reaction of carboxylic acids and alcohols or acetates will produce esters. In general terms, the following fatty acid derivatives such as esters (Ia) and other functionalities such as amides (Ib) are desirable for their stability and improved initial eye comfort:
CH3—CH2—CH═CH—(CH2—CH═CH)n—(CH2)x—CO—O—R (Ia)
CH3—CH2—CH═CH—(CH2—CH═CH)n—(CH2)x—CO—NH—R (Ib)
Such derivatives are then expected to be converted back to their original fatty acid structure (II):
CH3—CH2—CH═CH—(CH2—CH═CH)n—(CH2)x-acid {—CO—OH} (II)
Once in the ocular environment and/or incorporated into the lipid layer or cell membrane lipid bilayer to carry-on their tear film stabilization effect and/or anti-inflammatory effect.
The ranges of n, x and R can fall within the following ranges: n: 2-5; x: 2-7; R: ophthalmologically compatible leaving group included, but not limited to:
—(CH2)yCH3, where y is 0, 1 or above. In some embodiments y is between 0 and 5, or even 0 and 3, with y=1 being preferred.
Specifically, without limitation, the esterified anti-inflammatory lipid mediator comprises an esterified omega-three fatty acid, wherein the omega-three fatty acid is selected from the group consisting of: alpha-linolenic acid, stearidonic acid, eicosatetraenoic acid, eicosapentaenoic acid, docohexaenoic acid, docosapentaenoic acid (DPA), tetracosapentaenoic acid, and tetracosahexaenoic acid (Nisinic acid), derivatives, metabolites, and mixtures thereof. Upon esterification, the majority of the esterified anti-inflammatory lipid mediator is present in the ester form of the omega-three fatty acid.
Specially, esterified omega-three fatty acids can be selected from the following non-limiting examples: ethyl linolenate (alpha-linolenic acid ethyl ester (ALA-EE); stearidonic acid ethyl ester and stearidonic acid propyl ester; eicosatetraenoic acid ethyl ester and eicosatetraenoic acid propyl ester; eicosapentaenoic acid ethyl ester and eicosapentaenoic acid propyl ester; and docohexaenoic acid ethyl ester and docohexaenoic acid propyl ester.
The anti-inflammatory lipid mediator is reacted with a polyol having a carbon chain length of four to ten carbons to form the desired ester form of the anti-inflammatory lipid mediator.
The inflammatory lipid mediator and polyol are reacted under ester forming conditions. Suitable catalysts are known in the art and include acids, bases, carbodiimide, and the like. The esterification and amidation reactions can take place at room temperature (typically in the range of about 19-25° C.) without much need to go higher and ambient pressure, temperatures can be brought to higher ranges (about 25° C. to 80° C.) in order to accelerate the time to reaction completion.
Alternatively, the fatty acids may be esterified with polyethylene glycol or polyvinyl alcohol to generate omega fatty acid ethoxylates and alkoxylates. Moreover, mixtures of homologous molecules as well as amides and other functional derivatives may be desirable. For example, the esterified anti-inflammatory lipid mediator can be the reaction product of a fatty acid and an amine to form an amidoester.
Omega-three fatty acids may also be reacted with the following molecules/alcohols: inositol, sorbitol, xylitol, and erythritol. The advantage of using such ester forms/conjugated materials is that upon hydrolysis and release of the omega-three fatty acid material, the small solute/alcohol released in the process will provide osmoprotection and thus additional benefit, notably in dry eye subjects and/or contact lens wearers. This is because inositol, sorbitol, xylitol and erythritol are osmoprotecting agents, and are well tolerated in tissues in general.
In the case of polyols, such as inositol, several of the hydroxyl groups may be esterified to the omega-three fatty acid (e.g. alpha linolenic acid) to improve efficiency in terms of the amount of the omega-three fatty acid material that can be delivered to the tissue per each molecule. The number of fatty acid molecules per inositol molecule will affect the solubility of the material or allow adjusting the hydrophobicity of the material for specific applications/control the rate of delivery from the medical device.
It should be noted that an esterified anti-inflammatory lipid mediator does not take the form of naturally occurring oils including sunflower oil, sesame oil, castor oil, linseed oil, and the like. It should be further noted that the esterified anti-inflammatory lipid mediators of the present invention are not wax esters as they are formed from alcohols having short carbon chains (five to 10 carbon atoms, and in some embodiments 5-8 carbon atoms).
Mixtures may include omega-three and omega-six fatty acid esters at desired ratios. In one or more embodiments it is desirable to provide a composition which will, upon hydrolysis of the ester, provide a balance of omega-three fatty acid:omega-six fatty acid in the eye to about 1:1. In other embodiments it is desirable to provide ophthalmic compositions which have ratios of the omega-three fatty acid:omega-six fatty acid upon hydrolysis, in the range of about 10:about 1 to no less than about 1:about 1 and from about 5:1 to about 1:1,from about 4:1 to about 1:1, from about 3:1 to about 1:1,from about 2:1 to about 1:1, about 1:1, about 2:1, about 3:1,about 4:1, about 5:1, about 6:1, about 7:1, about 8:1, about 9:1, or about 10:1. The ratio is based on the total amount of each class of omega fatty acids.
Mixing of the ophthalmic compositions can be done under aseptic conditions, or under ambient conditions and then sterilized. Temperature can range widely, and the reactions may be performed under ambient conditions of temperature and pressure.
In addition to the usefulness of esterified anti-inflammatory lipid mediators as ingredients in ophthalmic compositions, including re-wetting drops, multipurpose solutions, cleaning and storing solutions and in contact lenses themselves, such materials are also candidates for their inclusion in lens packing solution. Lenses may be packaged with esterified anti-inflammatory lipid mediators in formulations and/or emulsions or may be hydrated in such materials as dissolved in appropriate solvent(s), followed by equilibration of the lens in packing solution.
Other ophthalmic compositions include lens care solutions such as multipurpose solutions, preparations, gels, ointments, emulsions, and ophthalmic products such as strips, inserts or punctal plugs or any product coming into contact with the ocular surface.
In one embodiment, the esterified anti-inflammatory lipid mediators are provided in an aqueous delivery system. Aqueous delivery systems are water-based systems, which can be instilled directly in the eye, or may be used to condition, store, or clean ophthalmic devices which are placed in the ocular environment. Examples of aqueous delivery systems can include one or more of the following: packing solutions, storing solutions, cleaning and care solutions, multipurpose solutions, conditioning solution and ophthalmic drops. The aqueous delivery systems may also include known components, such as one or more of emulsifiers, chelant agents, or stabilizers, surfactants, wetting agents, antioxidants, tonicity adjusting agents, preservatives, combinations thereof, and the like.
The packaging solution may be any water-based solution including that which is used for the storage of contact lenses. The esterified anti-inflammatory lipid mediators are dispersed in the packaging solution. Typical solutions include, without limitation, saline solutions, other buffered solutions, and deionized water. The preferred aqueous solution is saline solution containing salts including, without limitation, sodium chloride, sodium borate, sodium phosphate, sodium hydrogenphosphate, sodium dihydrogenphosphate, or the corresponding potassium salts of the same. These ingredients are generally combined to form buffered solutions that include an acid and its conjugate base, so that addition of acids and bases cause only a relatively small change in pH. The buffered solutions may additionally include 2-(N-morpholino)ethanesulfonic acid (MES), sodium hydroxide, 2,2-bis(hydroxymethyl)-2,2′,2″-nitrilotriethanol, n-tris(hydroxymethyl)methyl-2-aminoethanesulfonic acid, citric acid, sodium citrate, sodium carbonate, sodium bicarbonate, acetic acid, sodium acetate, and the like and combinations thereof. Preferably, the solution is a borate buffered or phosphate buffered saline solution.
To form the packaging solution, at least one surfactant or emulsifier along with any additional ingredients are combined with the water-based solution, stirred, and dissolved or dispersed. The pH of the solution preferably is adjusted to about 6.2 to about 7.5. The lens to be stored in the packaging solution of the invention is immersed in the solution and the solution and lens placed in the package in which the lens is to be stored. Alternatively, the solution may be placed into the package and the lens then placed into the solution. Typically, the package is then sealed by any convenient method, such as by heat sealing, and undergoes a suitable sterilization procedure.
The surfactants suitable for use in the invention are of any suitable molecular weight, preferably about 200 to about 1,000,000, more preferably about 1000 to about 18,000. Useful surfactants have a hydrophile-lipophile balance (“HLB”) of about 10 to about 30, preferably about 15 to about 25, more preferably about 15 to about 23.
Any of the known surfactants fitting the aforementioned criteria may be used provided that the surfactant is compatible, in terms of solubility, in the solution with which it is used. Thus, suitable surfactants include, without limitation, cationic, ionic, non-ionic surfactants, and combinations thereof. However, the use of a lens packaging solution containing cationic and ionic surfactants may cause eye irritation. Therefore, preferably the surfactant is a non-ionic surfactant.
Suitable non-ionic surfactants include, without limitation, polyethylene glycol esters of fatty acids, such as polysorbate 20, 60 or 80, all available as TWEEN® surfactants, alkanolamides, amine oxides, ethoxylated alcohols and acids, and surfactants having one or more poly(oxyalkylene) chains, such as poloxamine surfactants (a surface-active agent that removes lipid and environmental debris from the lenses; polyalkoxylated block polymers of ethylene diamine) or poloxamer surfactants (any of a series of nonionic surfactants of the polyoxypropylene-polyoxyethylene copolymer type, used as surfactants, emulsifiers, stabilizers, and food additives), and the like, and combinations thereof. Preferably, the surfactant is a polysorbate or poloxamer surfactant. Poloxamer surfactants are commercially available under the name PLURONIC200 that are polyoxyethylene-polyoxypropylene non-ionic surfactants having polyoxyethyl hydrophilic group ends that make up about 10 to about 80 percent by weight of the molecule. Although any of the PLURONIC® surfactants are preferred, particularly preferred for use in the invention is PLURONIC® 127, which is about 70 percent by weight ethylene oxide and has a molecular weight of about 12,000 to about 15,0000.
The surfactant may be combined with any known active and carrier components useful for lens packaging solution or for a rewetting drop. Suitable active ingredients for lens packaging solutions include, without limitation, antibacterial agents, anti-dryness agents, such as polyvinyl alcohol, polyvinylpyrrolidone, and dextran, tonicity agents, and the like, and combinations thereof
Suitable wetting agents, along with viscosity enhancers include, without limitation:methyl gluceth-20 (sold under the trade name, for example, Glucam E20), carboxymethylcellulose, dextran 70, gelatin, hydroxymethylcellulose, hydroxypropyl methylcellulose, hydroxypropylethylcellulose, hydroxypropyl cellulose, methylcellulose, PEG, propylene glycol, polyvinyl alcohol (PVA), polyvinylpyrrolidone (PVP), Carbomer, polymethylvinylethermaleic anhydride, hyaluronic acid, xanthan gum, and polyacrylicacid.
Suitable antioxidants used in this invention include, without limitation, hindered phenols, catechols, tocopherols, carotenoids, hyaluronic acid, lutein, or any species that can scavenge free radicals. Antioxidants are molecular species that inhibit oxidative damage of other chemicals through redox chemical reactions. These reactions typically transfer electrons for a molecule species to an oxidant molecule. These can include free radicals, which can cause chain reactions. In simplest terms, antioxidants are reducing agents. Examples of antioxidants include, without limitation: Vitamin E, Vitamin C, beta carotene (which is converted to Vitamin A), and peroxidases, and other agents which can inhibit the formation of free radicals, e.g., chelants, EDTA, diethylene triamine pentaacetic acid (DTPA), N, N-bis[carboxymethyl]glycine (NTA), and the like.
In some embodiments, Vitamin E is added to a solution comprising the esterified anti-inflammatory lipid mediator.
In another embodiment the composition of the present invention is incorporated into an ophthalmic device such as a contact lens or, more particularly, a silicone hydrogel contact lens. In this embodiment the esterified anti-inflammatory lipid mediators, wherein the majority of the anti-inflammatory lipid mediator is present in the ester form, may be incorporated into the lens in a number of ways, including but not limited to incorporating into the reaction mixture from which the lens is polymerized, contacting the lens with a solution comprising the esterified anti-inflammatory lipid mediators either before during or after packaging. For example, the esterified anti-inflammatory lipid mediators may be included in the extraction, hydration or storage solution during the manufacture of the lens or may be included in a solution which is contacted with the contact lens by the lens wearer. In one embodiment the solution swells the lens, which allows for enhanced uptake of the esterified anti-inflammatory lipid mediators. In embodiments where the esterified anti-inflammatory lipid mediator is incorporated into the reaction mixture, the esterified anti-inflammatory lipid mediator may be added to the reaction mixture as a separate component, or may be pre-reacted with the alcohol group on at least one of the reactive components.
In some embodiments, the present invention comprises ophthalmic compositions comprising at least one esterified omega-three fatty acid. In some embodiments, the present invention comprises ophthalmic compositions comprising at least one esterified omega-six fatty acid. In some embodiments, the present invention comprises ophthalmic compositions comprising at least one esterified omega-six fatty acid and at least one esterified omega-three fatty acid.
It is a benefit of the present invention that the esterified anti-inflammatory lipid mediators are hydrolytically stable at neutral pH, and do not hydrolyze during storage in the pH neutral ophthalmic composition and sterile preparations of the present invention. This means that the ophthalmic solutions and sterile preparations do not cause stinging when instilled in the eye. Upon contact with the cellular membranes and/or transport into the cells of the ocular surface, and without intending to be bound by theory, it is thought that esterified anti-inflammatory lipid mediators, such as esterified polyunsaturated fatty acids, esterified resolvins or a metabolically stable analog, esterified protectins or a metabolically stable analog, esterified lipoxins or a metabolically stable analog, esterified prostaglandins or a metabolically stable analog, esterified retinoic acids, endocannabinoids, and phospholipids, undergo hydrolysis and return to their acidic anti-inflammatory lipid mediator state along with the alcohol that was used in forming the ester.
The amounts of the esterified anti-inflammatory lipid mediator can be stated as a percentage of the total composition or as a percentage of the solution used in a processing step such as a lens hydration step (part of the lens making process that can result in the incorporation of the material into the device). The percentage of esterified anti-inflammatory lipid mediator can be determined by any method, but can, for example, be determined by dividing the weight of the anti-inflammatory lipid mediator by the total weight of the ophthalmic composition or device. The percentage of any component of the ophthalmic composition can be determined in a similar manner.
The amount of esterified anti-inflammatory lipid mediator which may be present in the ophthalmic compositions or devices of the present invention include from about 0.025 weight % to 5.0 weight % based upon all the components in the ophthalmiccomposition. When the ophthalmic composition is a rewetting drop, the esterified anti-inflammatory lipid mediator is present in an amount from about 0.025 weight % to 0.5 weight % based upon all of the components in the composition, and the acid content can be no more than 0.1 weight % (or 0.075, or 0.05, or 0.025, or even 0.01 weight %). When the ophthalmic composition is incorporated onto a contact lens, the esterified anti-inflammatory lipid mediator is present in an amount from 0.025 weight % to 5.0 weight % based upon all of the components in the composition, and the acid content can be no more than 1 weight % (or 0.75, or 0.5, or 0.25, or even 0.1 weight %).
In some embodiments, the invention is directed to the topical application of a composition comprising an esterified anti-inflammatory lipid mediator (e.g., esterified ALA) as an effective therapeutic strategy to decrease ocular surface inflammation. As discussed herein the inflammation of the ocular surface can be seen in, for example, dry eye syndrome and other inflammatory ocular conditions including, but not limited to, both anterior segment/front of the eye conditions and back of the eye conditions (e.g., meibomian gland dysfunction, blepharitis, atopic keratoconjunctivitis, contact lens related dry eye, Sjögren's syndrome, uveitis, macular degeneration, and a wide range of other conditions).
In another embodiment, the invention is directed to the topical application of a composition comprising an esterified anti-inflammatory lipid mediator (e.g., esterified ALA) as an effective strategy to improve tear film function or tear film stability. Without intending to be bound by theory, it is thought that the esterified anti-inflammatory lipid mediator improves the interaction between the lens and the tear film and/or the lids.
The present invention can also be administered to an individual that has been identified in need thereof of a composition described herein. The individual can be in need thereof, if the individual has been identified as suffering or having the condition of dry eye syndrome or one of the other inflammatory ocular conditions identified above. One in skill in the art would know how to identify the individual in need of a treatment for dry eye syndrome.
The present invention can also be administered to an individual to mitigate at least one sign and/or symptom of dry eye, or to provide osmoprotection to an individual in need thereof.
Without intending to be bound by theory, it is thought that when the anti-inflammatory lipid mediator composition is loaded onto a contact lens for delivery to the eye during contact lens wear, by virtue of its anti-inflammatory properties and the benefit provided to the tear film, the anti-inflammatory lipid mediator can be held on to the eye via the contact lens long enough to be delivered efficiently to the eye in order provide relief to individuals suffering from dry eye or other inflammatory ocular conditions.
Reference throughout this specification to “one embodiment,” “certain embodiments,” “one or more embodiments,” “further embodiment,” or “an embodiment” means that a particular feature, structure, material, or characteristic described in connection with the embodiment is included in at least one embodiment of the invention. Thus, the appearances of the phrases such as “in one or more embodiments,” “in certain embodiments,” “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily referring to the same embodiment of the invention. Furthermore, the particular features, structures, materials, or characteristics may be combined in any suitable manner in one or more embodiments.
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 will be apparent to those skilled in the art that various modifications and variations can be made to the method and apparatus of the present invention without departing from the spirit and scope of the invention. Thus, it is intended that the present invention include modifications and variations that are within the scope of the appended claims and their equivalents.
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16789793
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johnson & johnson vision care, inc.
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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 09:14AM
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Apr 27th, 2022 09:14AM
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Johnson & Johnson
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Health Care
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Pharmaceuticals & Biotechnology
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nyse:jnj
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Johnson & Johnson
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Apr 19th, 2022 12:00AM
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Feb 21st, 2013 12:00AM
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https://www.uspto.gov?id=US11305053-20220419
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Surgical handpiece having directional fluid control capabilities
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A medical system is provided having a system host and a control device connected to the system host. The medical system further includes a handpiece having a sleeve with a port opening configured to enable fluid to pass there through, a fluid channel connected to the port opening, and a fluid flow restrictor configured to restrict fluid flow of the fluid channel through the port opening. The control unit is configured to receive input from a user and control an amount of fluid provided by the fluid flow restrictor based on the input received from the user. In one aspect, the medical system is a phacoemulsification system, the handpiece a phacoemulsification handpiece, and the control device a footpedal.
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11305053
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1. A medical system comprising:
a system host device;
a handpiece connected to the system host device comprising:
a sleeve having a first port opening and a second port opening, wherein the first port opening and the second port opening independently dispense fluid therethrough,
a first fluid channel connected to the first port opening,
a second fluid channel connected to second port opening,
a first fluid flow restrictor that variably restricts irrigation fluid flow through the first fluid channel independent of a pressure of the fluid at the first fluid flow restrictor;
a second fluid flow restrictor that variably restricts irrigation fluid flow through the second fluid channel independent of a pressure of the fluid at the second fluid flow restrictor; and
a controller connected to the system host device;
wherein the system host device comprises instructions that when executed cause the system host to provide signals to the handpiece to electronically and individually control the first fluid flow restrictor and second fluid flow restrictor to control the direction of the fluid flow through the first fluid channel and the second fluid channel based on input received at the controller from a user.
2. The medical system of claim 1, wherein the first fluid flow restrictor comprises a hinged gate type mechanism configured to open and close based on signals received from the system host device.
3. The medical system of claim 1, wherein the controller is a dual axis footpedal.
4. The medical system of claim 1, wherein the controller is a footpedal, and signals received from the footpedal are employed by the system host to cause a bias in the amount of fluid provided by the first fluid channel and the second fluid channel.
5. The medical system of claim 3, wherein one axis of the footpedal is configured to control the first fluid flow restrictor and an alternate control input is configured to control the second fluid flow restrictor.
6. The medical system of claim 1, wherein the medical system is a phacoemulsification system and the handpiece is a phacoemulsification handpiece.
7. A handpiece configured for use in a medical system, comprising:
a sleeve comprising a first port opening and a second port opening, wherein the first pot opening and the second port opening independently dispense fluid therethrough;
a first fluid channel disposed within the handpiece and connected to the first port opening a second fluid channel disposed within the handpiece and connected to the second port opening;
a first fluid flow restrictor disposed within the handpiece that variably restricts irrigation fluid flow through the first fluid channel independent of a pressure of the fluid at the first fluid flow restrictor; and
a second fluid flow restrictor disposed within the handpiece that variably restricts irrigation fluid flow through the second fluid channel independent of a pressure of the fluid at the second fluid flow restrictor;
wherein the handpiece:
receives a signal from a control unit, wherein the signal is based on an input from a user, and electronically and individually controls a degree of opening of the first fluid flow restrictor and the second fluid flow restrictor to control the direction of the irrigation fluid flow through the first fluid channel and the direction of the irrigation fluid flow through the second fluid channel based on the signal.
8. The handpiece of claim 7, wherein the first fluid flow restrictor comprises a hinged gate type mechanism configured to open and close based on signals received from the control unit.
9. The handpiece of claim 7, wherein the control unit comprises a dual axis footpedal.
10. The handpiece of claim 7, wherein the control unit comprises a footpedal, and the handpiece is configured to receive signals from the footpedal and control the first fluid flow restrictor and the second fluid flow restrictor based on the signals received from the footpedal.
11. The handpiece of claim 9, wherein:
the first fluid flow restrictor is controlled based on movement of the footpedal along a first axis; and
the second fluid flow restrictor is controlled based on a state of an alternate input mechanism provided with the footpedal.
12. The handpiece of claim 7, wherein the handpiece is a phacoemulsification handpiece.
13. A medical system comprising a system host and a control device connected to the system host, the medical system further comprising:
a handpiece communicatively connected to the system host, comprising:
a sleeve comprising a first port opening and a second port opening,
wherein the first port opening and the second port opening independently dispense fluid therethrough,
a first fluid channel disposed within the handpiece and connected to the first port opening,
a second fluid channel disposed within the handpiece and connected to the second port opening,
a first fluid flow restrictor disposed within the handpiece that variably restricts irrigation fluid flow through the first fluid channel independent of a pressure of the fluid at the first fluid flow restrictor; and
a second fluid flow restrictor disposed within the handpiece that variably restricts irrigation fluid flow through the second fluid channel independent of a pressure of the fluid at the second fluid flow restrictor;
wherein the control device:
receives input from a user, and
generates a control signal based on the input to control an amount of irrigation fluid and direction of irrigation fluid dispensed by the first port opening and the second port opening based on the input received from the user;
wherein the handpiece:
receives the control signal, and
electronically and individually controls a degree of opening of the first fluid flow restrictor and the second fluid flow restrictor, respectively, to control the amount of irrigation fluid and direction of the irrigation fluid flow through the first fluid channel and the amount of irrigation fluid and direction of the irrigation fluid flow through the second fluid channel based on the control signal.
14. The medical system of claim 13, wherein the first fluid flow restrictor comprises a hinged gate type mechanism configured to open and close based on signals received from the control device.
15. The medical system of claim 13, wherein the control device comprises a footpedal.
16. The medical system of claim 13, wherein the control device comprises a dual axis footpedal, and the handpiece further:
receives signals from the footpedal, and
controls the first-fluid flow restrictor and the second flow restrictor based on the signal from the footpedal.
17. The medical system of claim 15, wherein:
the first fluid flow restrictor is controlled based on movement of the footpedal along a first axis; and
the second fluid flow restrictor is controlled based on a state of an alternate input mechanism provided with the footpedal.
18. The medical system of claim 13, wherein the medical system is a phacoemulsification system and the handpiece is a phacoemulsification handpiece.
19. A medical system comprising:
a system host device;
a handpiece connected to the system host device comprising:
a sleeve having a first port opening and a second port opening wherein the first port opening and the second port opening independently dispense fluid therethrough,
a first fluid channel connected to the first port opening,
a second fluid channel connected to the second port opening,
a first fluid flow restrictor that restricts irrigation fluid flow through the first fluid channel, and
a second fluid flow restrictor that restricts irrigation fluid flow through the second fluid channel; and
a controller communicatively connected to the system host device;
wherein the system host device comprises instructions that when executed cause the system host to provide signals to the handpiece to electronically and independently control the first fluid flow restrictor and the second fluid flow restrictor to control the direction of the fluid flow through the first fluid channel and the direction of the fluid flow through the second fluid channel based on input received at the controller from a user, and wherein the control of the first fluid flow restrictor and second fluid flow restrictor is independent of a pressure of the fluid flow through the first fluid channel and the second fluid channel.
20. The handpiece of claim 7, wherein the handpiece is configured to control a degree of restriction imposed on the irrigation fluid by the first fluid flow restrictor and the second fluid flow restrictor based on the signal.
21. The handpiece of claim 7, wherein the first fluid flow restrictor is configured to change degree of opening through which the irrigation fluid flows based on the signal, and
wherein the second fluid flow restrictor is configured to change degree of opening through which the irrigation fluid flows based on the signal,
wherein the first fluid flow restrictor and the second fluid flow restrictor are independently controlled.
22. The handpiece of claim 21, wherein the degree of opening includes fully closed, fully open, and partially open.
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CROSS-REFERENCE TO RELATED APPLICATIONS
This application claims priority to U.S. provisional application No. 61/651,751, entitled “Surgical Handpiece Having Directional Fluid Control Capabilities”, filed on May 25, 2012, the entire contents of which are hereby incorporated by reference in their entirety for all purposes as if fully set forth herein.
BACKGROUND OF THE INVENTION
I. Field
The present invention generally relates to fluid delivery using handpieces and more specifically to directional handpiece irrigation and/or aspiration control during surgical procedures.
II. Description of the Related Art
Phacoemulsification refers to a method of lens and cataract extraction from an eye. The procedure includes an ultrasonically vibrated needle which is inserted through a very small incision in the cornea in order to provide energy for fragmenting the lens and cataract which then can be aspirated and removed through the incision.
The needle is supported by a handpiece interconnected with a console which provides electrical power to the handpiece as well as a supply of irrigation fluid used to irrigate or provide fluid to the eye and a vacuum source for aspiration or removal of fragmented tissue and liquids.
Certain current handpieces can provide fluid to the eye during the surgical procedure. In general, at least one port is provided in the handpiece, frequently in the sleeve of the handpiece, and two ports are sometimes provided. Flow issues can arise when the surgeon wishes to control the direction of fluid flow, either using irrigation or aspiration.
Surgeons must be careful with fluid flow in that fluid flow directed toward certain parts of the eye chamber, such as the retina or cornea, can potentially harm those regions. Further, some surgeons wish to employ the fluid in conjunction with the needle to more rapidly acquire and/or break apart the unwanted cataract materials. Such surgeons employ fluid flow and ultrasonic power in tandem, and if the surgeon does not know the orientation of fluid flow, he runs the risk of moving the fluid in an undesired direction, for example pushing away material he wishes to work on and break up. Such an occurrence could potentially extend the duration of the surgery, and is undesirable.
In efforts to address these flow issues, surgeons have on occasion moved the handpiece such that the port arrangement provides flow in the desired direction. The result of such movement can be repositioning the needle into an undesirable orientation. Alternately, the surgeon can simply work with the flow provided, potentially causing a random flow of fluid that does not accomplish the desired irrigation task. The result is a partially or even completely obscured field resulting from the swirling of emulsified material, a phenomenon referred to as “milking” or “clouding.” Each of the foregoing situations, wherein constant fluid flow direction is provided, is less than ideal.
One further issue with such devices is controlling the fluid. Fluid control can be difficult in that the surgeon is performing a delicate procedure, and requiring her to engage a button on the handpiece or a button on a console would likely interrupt the procedure and/or require an inordinate amount of control and dexterity. Controlling direction may take more than pushing a single on/off button, but instead may require multiple directional inputs and potentially an input controlling flow rate or volume. As a result, devices to control fluid direction could be highly complicated and could potentially require actions by another person, or inordinately excessive dexterity or manual actions by the surgeon. Again, such situations are unacceptable, particularly in a surgical environment where patient safety and surgeon concentration are paramount considerations.
It would therefore be desirable to provide a phacoemulsification fluid irrigation and aspiration design, including an apparatus to control irrigation and aspiration direction that minimizes the adverse aspects previously known in such devices.
SUMMARY
The following presents a simplified summary in order to provide a basic understanding of some aspects of the claimed subject matter. This summary is not an extensive overview, and is not intended to identify key/critical elements or to delineate the scope of the claimed subject matter. Its sole purpose is to present some concepts in a simplified form as a prelude to the more detailed description that is presented later.
The present invention includes a medical system having a system host and a control device connected to the system host. The medical system further includes a handpiece having a sleeve with a port opening configured to enable fluid to pass therethrough, a fluid channel connected to the port opening, and a fluid flow restrictor configured to restrict fluid flow of the fluid channel through the port opening. The control unit is configured to receive input from a user and control an amount of fluid provided by the fluid flow restrictor based on the input received from the user. In one aspect, the medical system is a phacoemulsification system, the handpiece a phacoemulsification handpiece, and the control device a dual axis footpedal.
To the accomplishment of the foregoing and related ends, certain illustrative aspects are described herein in connection with the following description and the annexed drawings. These aspects are indicative, however, of but a few of the various ways in which the principles of the claimed subject matter may be employed and the claimed subject matter is intended to include all such aspects and their equivalents. Other advantages and novel features may become apparent from the following detailed description when considered in conjunction with the drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a general depiction of a medical system in accordance with an embodiment of the present design;
FIG. 2 illustrates a representative handpiece that may be employed with the present design;
FIG. 3 is an alternate view of a handpiece that may be employed with the present design;
FIG. 4 is a representative view of a handpiece having two fluid flow restrictors in accordance with one embodiment of the present design;
FIG. 5 shows an alternate view of the handpiece similar to that of FIG. 4 with one fluid restrictor open and one fluid flow restrictor closed;
FIG. 6 is a further alternate view of a handpiece similar to that in FIG. 4 with one fluid restrictor fully open and one fluid restrictor partially open; and
FIG. 7 is an expanded view of the right side of the handpiece shown in FIG. 6 with partial flow through one fluid channel; and
FIG. 8 illustrates an example of a dual axis footpedal that may be employed with the present design.
DETAILED DESCRIPTION
In this document, the words “embodiment,” “variant,” and similar expressions are used to refer to particular apparatus, process, or article of manufacture, and not necessarily to the same apparatus, process, or article of manufacture. Thus, “one embodiment” (or a similar expression) used in one place or context can refer to a particular apparatus, process, or article of manufacture; the same or a similar expression in a different place can refer to a different apparatus, process, or article of manufacture. The expression “alternative embodiment” and similar phrases are used to indicate one of a number of different possible embodiments. The number of possible embodiments is not necessarily limited to two or any other quantity.
The word “exemplary” is used herein to mean “serving as an example, instance, or illustration.” Any embodiment or variant described herein as “exemplary” is not necessarily to be construed as preferred or advantageous over other embodiments or variants. All of the embodiments and variants described in this description are exemplary embodiments and variants provided to enable persons skilled in the art to make or use the invention, and not to limit the scope of legal protection afforded the invention, which is defined by the claims and their equivalents.
The present design includes a controllable fluid flow restrictor arrangement in connection with a phacoemulsification handpiece, wherein fluid lines can be selectively blocked by a surgeon or operator to control both the amount of fluid flow and the direction of fluid flow in aspiration and/or irrigation situations. The design includes impeding the fluid path on a selective basis, such as partially or completely closing a fluid path as desired. The present design may be operated using a control device such as a footpedal, in one embodiment a dual axis footpedal, wherein surgeon foot movement in the pitch direction of the dual axis footpedal can, in one example, control fluid flow by opening and closing one flow restrictor and movement in the yaw axis can control fluid flow by opening and closing a second flow restrictor, thus controlling the amount of fluid provided to or from ports provided on the handpiece. Control may alternately be provided by other devices, such as a single axis footpedal, where fluid direction is controlled in the pitch direction as well as side switches, for example. Side switches may be switches engageable by the surgeon's foot provided on the side of the footpedal, where the surgeon taps the side switch to increase flow in increments in a given direction or otherwise control fluid flow.
System Example
While the present design may be used in various environments and applications, it will be discussed herein with a particular emphasis on an environment where a surgeon or health care practitioner performs. For example, one embodiment of the present design is in or with an ocular surgical system that comprises an independent graphical user interface (GUI) host module, an instrument host module, a GUI device, and a controller module, such as a foot pedal, to control the surgical system.
FIG. 1 illustrates an exemplary phacoemulsification/vitrectomy system 100 in a functional block diagram to show the components and interfaces for a safety critical medical instrument system that may be employed in accordance with an aspect of the present invention. A serial communication cable 103 connects GUI host 101 module and instrument host 102 module for the purposes of controlling the surgical instrument host 102 by the GUI host 101. Instrument host 102 may be considered a computational device in the arrangement shown, but other arrangements are possible. An interface communications cable (not shown) may be connected to instrument host 102 module for distributing instrument sensor data, and may include distribution of instrument settings and parameters information, to other systems, subsystems and modules within and external to the instrument host 102 module. An interface communications cable may be connected or realized on any other subsystem (not shown) that could accommodate such an interface device able to distribute required data.
A switch module associated with foot pedal 104 may transmit control signals relating internal physical and virtual switch position information as input to the instrument host 102 over serial communications cable 105. A wireless footpedal may alternately be provided. Instrument host 102 may provide a database file system for storing configuration parameter values, programs, and other data saved in a storage device (not shown). In addition, the database file system may be realized on the GUI host 101 or any other subsystem (not shown) that could accommodate such a file system.
The example system 100 in FIG. 1 has a handpiece 110 that includes a needle and electrical means, typically a piezoelectric crystal, for ultrasonically vibrating the needle. The instrument host 102 supplies power on line 111 to a phacoemulsification/vitrectomy handpiece 110. An irrigation fluid source 112 can be fluidly coupled to handpiece 110 through line 113. The irrigation fluid and ultrasonic power are applied by handpiece 110 to an eye, or affected area or region, indicated diagrammatically by block 114. Alternatively, the irrigation source may be routed to eye 114 through a separate pathway independent of the handpiece. Aspiration is provided to eye 114 by a pump (not shown), such as a peristaltic pump and/or Venturi pump, via the instrument host 102, through lines 115 and 116. A surgeon/operator may select an amplitude of electrical pulses using the handpiece, or via the instrument host and GUI host, or using a footpedal or switch provided on a footpedal.
FIG. 1 represents an example design that may employ the present invention, but other implementations are possible. For example, rather than a phacoemulsification or vitrectomy handpiece, the present design may be provided on a device that simply controls fluid, called an I/A (Irrigation/Aspiration) handpiece. (Irrigation/Aspiration) employed together with a handpiece comprising a needle, where the second handpiece may include fluid irrigation and/or aspiration functionality.
Handpiece Design
FIG. 2 illustrates a representative handpiece 200 having similarity to the handpiece of the present design. From FIG. 2, handpiece 200 includes fluid line 201, base 202, and includes sleeve 203. Sleeve 203 houses the needle 204, partially shown through the port 205 near the tip of sleeve 203. Aspiration line 206 is used to remove fluid from the site.
FIG. 3 illustrates a perspective view of the sleeve 203. The needle 301 can be seen through port 302 in this view. The needle 301 moves through opening 303 and is employed to break up the cataract. Port 302 is located on one side of the sleeve 203, while a second port is not shown but is located on the other side of the sleeve 203. Multiple ports may be provided, including more than two ports, while still within the scope of the present invention.
FIG. 4 is a conceptual representation of the handpiece 400 presented to show, among other attributes, fluid flow in the present design. In FIG. 4, the fluid input is provided via lines 401 and 402. The two lines may be separately fed, or more typically a single fluid line may be provided to handpiece 400 and the handpiece constructed such that the fluid from the single input line is directed to lines 401 and 402. In this arrangement, fluid passes to the two paths and can be impeded by gates 403 and 404. Gates 403 and 404 are pivoted elements constructed of a durable material, that when closed stop the flow of fluid to the associated line. In FIG. 4, both gates 403 and 404 are fully open, allowing fluid to pass through. Two lines 401 and 402 are shown with a single gate associated with each line. An additional fluid opening or additional fluid openings may be provided in the sleeve or elsewhere on the handpiece, for example to provide a baseline flow from one opening (not shown) in addition to a controllable flow provided using gates 403 and 404. Also, more or less than two gates and lines may also be provided in the handpiece, and position of the openings may differ from those illustrated in FIG. 4. More or fewer lines may also be provided in the handpiece. The goal is to provide a level of differentiation in fluid flow by the handpiece that is controllable by the user.
In FIG. 4, with both gates open, irrigation fluid flows through two channels in the sleeve, thus providing side port irrigation. Such an arrangement aids in keeping particles centered near the tip of needle 407. Fluid flows into the handpiece as shown, flowing through lines 401 and 402 with gates 403 and 404 open in the configuration of FIG. 4. Once fluid passes through lines 401 and 402, the fluid flows out of ports 405 and 406 in sleeve 408.
When the user desires to change the flow of the FIG. 4 design, she may provide control input causing at least one of the gates 403 and 404 to at least partially close. Surgeon control methodology is discussed below, with one method for providing control using a dual axis footpedal. The surgeon may engage the device to partially close one gate, decreasing flow through the associated opening, or may elect to completely close one gate, such as gate 403, thus closing the flow of fluid, or may partially close gate 403, decreasing the amount of fluid flow. As may be appreciated, when the gates 403 or 404 are closed, the fluid connection preferably does not allow any fluid to flow, i.e. is preferably sealed or watertight. Various gaskets or other devices known in the art may be employed to keep fluid from flowing when a gate is closed.
Gates may be biased in a closed or open orientation. In the example of FIG. 4, the gates are assumed biased open allowing fluid to flow through. Subsequently engaging gate 403 results in a narrowing of the opening and a relatively small fluid flow coming from opening 405 and a large or unabated fluid flow coming from opening 406. This flow differential enables the user to move unwanted ocular material in a desired direction. Note that both gates 403 and 404 can be partially or completely closed at any time, altering flow as desired.
While FIG. 4 and various other figures in the present design show the use of gates, any type of flow restriction device may be employed that inhibits fluid flow through an available fluid channel. Devices such as pinch valves or other pinch mechanisms configured to compress deformable tubes, or other known mechanisms for inhibiting fluid flow may be employed. Such devices may be referred to generally as fluid flow restrictors, where a gate as shown in FIG. 4 is one example of a fluid flow restrictor.
FIG. 5 illustrates the situation when one gate in the handpiece is closed. From FIG. 5, lines 501 and 502 are provided in handpiece 500, with gates 503 and 504. Gate 504 is closed in FIG. 5, resulting in no flow from opening 506 and flow from opening 505 in sleeve 507. This enables the surgeon to direct irrigation fluid through only one fluid channel in the sleeve, thus providing a bias to the irrigation. FIG. 6 illustrates attenuated dual side port irrigation, where handpiece 600 includes lines 601 and 602. Gate 603 is open in this configuration, with gate 604 partially open. Full irrigation fluid flow emanates from opening 605, while partial fluid flow comes from opening 606 in sleeve 607. The FIG. 6 implementation enables irrigation fluid to be partially or proportionately directed through each available fluid channel in the sleeve 607, thus providing a slight bias to the irrigation. Such an implementation aids in directing particles back toward the center of the ocular chamber without a full bias on one side of handpiece 600.
FIG. 7 illustrates an expanded view of the right side or proximal part of handpiece 600. As shown in FIG. 7, line 601 is open as gate 603 is in an open position. Fluid coming through incoming line 701 is not impeded and flows into line 601. These fluid lines are referred to as fluid channels. Line 602 is partially open as gate 604 is in a partially open/partially closed state. Fluid coming through incoming line 702 is partially impeded by gate 604 and only part of the fluid flows to line 603. As shown, the gate 604 rotates or pivots about the point closest to the tip of handpiece 600, but other orientations may be employed.
The present design may employ any control method that will enable the surgeon to control the fluid flow in a desired manner. While the foregoing illustrations discuss potential partial control, such as partially opening gates, it is to be understood that control in an on/off or open/closed manner. This on/off type operation provides limited control, but may be implemented using a simple control device such as a button or buttons on the handpiece or footpedal (not shown).
One other control implementation is the use of a dual axis footpedal such as one shown in FIG. 8. The dual axis footpedal 800 enables movement in a fore-and-aft (pitch) direction and a side-to-side (yaw) direction. The user can control, for example, flow on one side of the handpiece in one axis and flow on the other side of the handpiece with the other axis, such as pitch direction controlling gate 403 and yaw axis controlling gate 404. In this example, the user having his foot off the footpedal 800 results in both gates being open. Movement in the pitch direction would progressively close gate 403, and movement in either yaw direction, left or right, would progressively close gate 404. Other implementations may be realized, such as where the neutral position results in a full fluid flow, i.e. both gates fully open, and shifting in one direction in yaw results in one gate, such as gate 403, progressively closing and in the other direction causing the other gate to close, such as gate 404. In this example, the pitch axis would provide no control. Such an implementation would require one gate to be fully open throughout the procedure. Other control implementations using footpedal 800, or a different type of footpedal such as a single axis footpedal with or without footpedal switches, may be realized.
Various footpedal devices have been used to control an ophthalmic or phacoemulsification/vitrectomy surgical apparatus. Footpedal systems, such as that described in U.S. Pat. No. 4,983,901 provide for a virtually unlimited number of control variations and modes for operating phacoemulsification apparatuses. Additional single linear and dual linear foot pedal patents include U.S. Pat. Nos. 5,268,624; 5,342,293; 6,260,434; 6,360,630; 6,452,120; 6,452,123; and 6,674,030.
In operation, footpedal 800 is connected to instrument host 102 of phacoemulsification/vitrectomy system 100. Instrument host 102 may include logic or software effectuating fluid flow in handpiece 400 as described herein, namely opening or closing available gates in a manner desired. Instrument host 102 provides a connection to handpiece 400, for example, and gates 403 and 404 such that the gates may be opened and closed based on input from the footpedal 800. The ability to set control parameters may be provided, such as a surgeon desiring a right yaw movement to close gate 404 and a left yaw movement to close gate 403, with varying pitch ranges having different gate movement characteristics. For example, a nonlinear profile may be provided, such as a zero to 25 percent footpedal yaw position being linear from zero to 25 percent gate closure, 25 to 75 percent footpedal yaw position corresponding to 50 percent gate closure, and 75 to 100 percent footpedal yaw position again being linear between 75 and 100 percent. The user may have a profile accessible to or receivable by instrument host 102 such that his desired settings may be employed.
In a case where alternate gate and fluid line embodiments are provided, such as in the case of three or four gates, control using a dual linear footpedal such as shown in FIG. 8 may be altered. Depending on circumstances, in a three gate arrangement, control may be provided in a manner such as the pitch axis controlling one channel from completely open to completely closed, with the yaw axis controlling the other two channels, such as yawing to the left controlling a second channel from full open at the center position to full closed at the far left extreme position, and yawing to the right controlling the third channel from full open at the center position to full closed at the far right extreme position.
Other implementations are possible, and options may be provided to the surgeon for preferred control using the footpedal. One alternate embodiment employs a single axis footpedal having foot switches engageable by the surgeon. Foot switches provide not only on/off functionality, but also may provide for incremental increases and/or decreases for each foot tap by the surgeon. For example, the foot pedal may provide for a flow rate, with the neutral position representing full flow and fully depressed representing minimal or zero fluid flow. One or more footpedal switches may be employed by, for example, tapping on one footpedal switch to close one gate a certain amount thereby biasing flow in one direction, where the other foot pedal may enable the surgeon to decrease the amount of bias in that direction. Alternately, the second switch may bias in a different direction, such as in an opposite direction from the bias provided by the first switch. In such a situation, a reset may be provided, such as via an additional switch, or the switches may be programmed to begin opening a gate after a maximum number of taps has occurred.
When a fourth channel is employed, control may be paired between two channels. One four channel orientation provides two fluid exits on opposite sides of the handpiece with two gates uniformly controlled and two separate fluid exits generally ninety degrees from the first channels. Considering the view of the handpiece looking straight on at the tip, the four fluid exits may be positioned at zero degrees, 90 degrees, 180 degrees, and 270 degrees, with the zero and 180 degree ports or openings having channels attached thereto that are uniformly controlled, such as by using the pitch axis of the footpedal 800, with the 90 and 270 degree ports controlled using the yaw axis of footpedal 800. Other implementations may be employed.
While operation has been described with single gate or fluid flow restrictor operation control using movement along one axis in a footpedal or using one variable in a control device, alternate implementations are possible. As an example, a neutral setting may result in a 50 percent fluid flow rate to or from one port and 50 percent fluid flow to or from another port. When a surgeon yaws the footpedal in one direction, such as left, the flow may increase in one direction with an equal decrease in the other direction, effectively providing 75 percent/25 percent or zero percent/100 percent fluid flow.
While discussed herein primarily with respect to irrigation, the present design may be employed for aspiration in general and differential directional aspiration in particular. In such an arrangement, two handpieces may be provided, wherein one handpiece provides irrigation and ultrasonic power to a needle and the other handpiece is used for aspiration. In the alternative, one handpiece may control the ultrasonic power and aspiration while the other handpiece is used for irrigation. Again, multiple fluid channels may be provided, with fluid flow restrictors employed to partially or completely inhibit aspiration of the fluid from the ocular region through the port and out via the fluid channel. Differential control may be provided using a control device such as a footpedal, but when two handpieces are provided, either multiple input or control devices must be provided or simple control may be provided, such as only one fluid flow restrictor in one handpiece (e.g. one irrigation fluid flow restrictor) being controlled by movement in the pitch direction of the footpedal and the other handpiece having one fluid flow restrictor (e.g. one aspiration fluid flow restrictor) controlled by movement of the footpedal in the yaw axis. More than one fluid flow restrictor may be controlled by the control device, either in concert or separately.
One alternative embodiment comprises providing flow out the distal tip of the handpiece when the handpiece takes the form of the handpiece of FIGS. 2 and 3. In this arrangement, constant flow is provided out a distal channel (not shown) created by the needle 301 and sleeve 203. In this embodiment, a device such as a footpedal may be employed to control fluid flow and/or change direction of flow in a manner similar to the use of gates in lines similar to lines 401 and 402.
Thus the present design may include a system host and a control device connected to the system host. The medical system further includes a handpiece having a sleeve with a port opening configured to enable fluid to pass there through, a fluid channel connected to the port opening, and a fluid flow restrictor configured to restrict fluid flow of the fluid channel through the port opening. The control unit is configured to receive input from a user and control an amount of fluid provided by the fluid flow restrictor based on the input received from the user. In one aspect, the medical system is a phacoemulsification system, the handpiece a phacoemulsification handpiece, and the control device a footpedal.
What has been described above includes examples of one or more embodiments. It is, of course, not possible to describe every conceivable combination of components or methodologies for purposes of describing the aforementioned embodiments, but one of ordinary skill in the art may recognize that many further combinations and permutations of various embodiments are possible. Accordingly, the described embodiments are intended to embrace all such alterations, modifications and variations that fall within the spirit and scope of the appended claims. Furthermore, to the extent that the term “includes” is used in either the detailed description or the claims, such term is intended to be inclusive in a manner similar to the term “comprising” as “comprising” is interpreted when employed as a transitional word in a claim.
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13772803
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johnson & johnson surgical vision, inc.
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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 03:03PM
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Apr 20th, 2022 03:03PM
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Johnson & Johnson
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Health Care
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Pharmaceuticals & Biotechnology
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nyse:jnj
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Johnson & Johnson
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Apr 19th, 2022 12:00AM
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Feb 25th, 2020 12:00AM
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https://www.uspto.gov?id=USD0949348-20220419
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Adhesive bandage with decorated pad
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D949348
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We claim the ornamental design for an adhesive bandage with decorated pad, as shown and described.
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1
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FIG. 1 is a top perspective view of the present invention;
FIG. 2 is a top view of the adhesive bandage with decorated pad depicted in FIG. 1;
FIG. 3 is a left side view of the adhesive bandage with decorated pad depicted in FIG. 1;
FIG. 4 is a bottom view of the adhesive bandage with decorated pad depicted in FIG. 1;
FIG. 5 is a right side view of the adhesive bandage with decorated pad depicted in FIG. 1;
FIG. 6 is a front side view of the adhesive bandage with decorated pad depicted in FIG. 1;
FIG. 7 is a back side view of the adhesive bandage with decorated pad depicted in FIG. 1;
FIG. 8 is a top perspective view of a second embodiment of the present invention;
FIG. 9 is a top view of the adhesive bandage with decorated pad depicted in FIG. 8;
FIG. 10 is a left side view of the adhesive bandage with decorated pad depicted in FIG. 8;
FIG. 11 is a bottom view of the adhesive bandage with decorated pad depicted in FIG. 8;
FIG. 12 is a right side view of the adhesive bandage with decorated pad depicted in FIG. 8;
FIG. 13 is a front side view of the adhesive bandage with decorated pad depicted in FIG. 8;
FIG. 14 is a back side view of the adhesive bandage with decorated pad depicted in FIG. 8;
FIG. 15 is a top perspective view of a third embodiment of the present invention;
FIG. 16 is a top view of the adhesive bandage with decorated pad depicted in FIG. 15;
FIG. 17 is a left side view of the adhesive bandage with decorated pad depicted in FIG. 15;
FIG. 18 is a bottom view of the adhesive bandage with decorated pad depicted in FIG. 15;
FIG. 19 is a right side view of the adhesive bandage with decorated pad depicted in FIG. 15;
FIG. 20 is a front side view of the adhesive bandage with decorated pad depicted in FIG. 15;
FIG. 21 is a back side view of the adhesive bandage with decorated pad depicted in FIG. 15;
FIG. 22 is a top perspective view of a fourth embodiment of the present invention;
FIG. 23 is a top view of the adhesive bandage with decorated pad depicted in FIG. 22;
FIG. 24 is a left side view of the adhesive bandage with decorated pad depicted in FIG. 22;
FIG. 25 is a bottom view of the adhesive bandage with decorated pad depicted in FIG. 22;
FIG. 26 is a right side view of the adhesive bandage with decorated pad depicted in FIG. 22;
FIG. 27 is a front side view of the adhesive bandage with decorated pad depicted in FIG. 22;
FIG. 28 is a back side view of the adhesive bandage with decorated pad depicted in FIG. 22;
FIG. 29 is a top perspective view of a fifth embodiment of the present invention;
FIG. 30 is a top view of the adhesive bandage with decorated pad depicted in FIG. 29;
FIG. 31 is a left side view of the adhesive bandage with decorated pad depicted in FIG. 29;
FIG. 32 is a bottom view of the adhesive bandage with decorated pad depicted in FIG. 29;
FIG. 33 is a right side view of the adhesive bandage with decorated pad depicted in FIG. 29;
FIG. 34 is a front side view of the adhesive bandage with decorated pad depicted in FIG. 29;
FIG. 35 is a back side view of the adhesive bandage with decorated pad depicted in FIG. 29;
FIG. 36 is a top perspective view of a sixth embodiment of the present invention;
FIG. 37 is a top view of the adhesive bandage with decorated pad depicted in FIG. 36;
FIG. 38 is a left side view of the adhesive bandage with decorated pad depicted in FIG. 37;
FIG. 39 is a bottom view of the adhesive bandage with decorated pad depicted in FIG. 38;
FIG. 40 is a right side view of the adhesive bandage with decorated pad depicted in FIG. 39;
FIG. 41 is a front side view of the adhesive bandage with decorated pad depicted in FIG. 40; and,
FIG. 42 is a back side view of the adhesive bandage with decorated pad depicted in FIG. 41.
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29725413
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johnson & johnson consumer inc.
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USA
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S1
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Design Patent
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Open
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D24/189
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15
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Apr 20th, 2022 03:03PM
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Apr 20th, 2022 03:03PM
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Johnson & Johnson
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Health Care
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Pharmaceuticals & Biotechnology
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nyse:jnj
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Johnson & Johnson
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Apr 19th, 2022 12:00AM
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Mar 24th, 2021 12:00AM
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https://www.uspto.gov?id=USD0949330-20220419
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Absorbent article
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D949330
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We claim the ornamental design for an absorbent article, as shown and described.
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1
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FIG. 1 is a perspective view of an absorbent article according to a third embodiment of the present invention;
FIG. 2 is a top plan view of the absorbent article according to the embodiment of FIG. 1;
FIG. 3 is a side view of the absorbent article according to the embodiment of FIG. 1;
FIG. 4 is a bottom plan view of the absorbent article according to the embodiment of FIG. 1;
FIG. 5 is a first end view of the absorbent article according to the embodiment of FIG. 1; and,
FIG. 6 is a second end view of the absorbent article according to the embodiment of FIG. 1.
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29775564
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johnson & johnson consumer inc.
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USA
|
S1
|
Design Patent
|
Open
|
D24/125
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15
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Apr 20th, 2022 03:03PM
|
Apr 20th, 2022 03:03PM
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Johnson & Johnson
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Health Care
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Pharmaceuticals & Biotechnology
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nyse:jnj
|
Johnson & Johnson
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Apr 19th, 2022 12:00AM
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Feb 25th, 2020 12:00AM
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https://www.uspto.gov?id=USD0949347-20220419
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Adhesive bandage with decorated pad
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D949347
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We claim the ornamental design for an adhesive bandage with decorated pad, as shown and described.
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1
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FIG. 1 is a top perspective view of the present invention;
FIG. 2 is a top view of the adhesive bandage with decorated pad depicted in FIG. 1;
FIG. 3 is a left side view of the adhesive bandage with decorated pad depicted in FIG. 1;
FIG. 4 is a bottom view of the adhesive bandage with decorated pad depicted in FIG. 1;
FIG. 5 is a right side view of the adhesive bandage with decorated pad depicted in FIG. 1;
FIG. 6 is a front side view of the adhesive bandage with decorated pad depicted in FIG. 1; and,
FIG. 7 is a back side view of the adhesive bandage with decorated pad depicted in FIG. 1.
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29725409
|
johnson & johnson consumer inc.
|
USA
|
S1
|
Design Patent
|
Open
|
D24/189
|
15
|
Apr 20th, 2022 03:03PM
|
Apr 20th, 2022 03:03PM
|
Johnson & Johnson
|
Health Care
|
Pharmaceuticals & Biotechnology
|
|
nyse:jnj
|
Johnson & Johnson
|
Apr 12th, 2022 12:00AM
|
Feb 28th, 2014 12:00AM
|
https://www.uspto.gov?id=US11298201-20220412
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Sterile drape for a surgical display and method related thereto
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A method of providing a sterile drape for covering a display of a phacoemulsification console may include providing the sterile drape in a sterile package dedicated for a patient, enabling removal of the sterile drape from the package by a sterile user, providing a finger guard pocket in the sterile drape suitable for receiving fingers of the sterile user, and providing a fitted pocket to allow for fitting of the sterile drape over the display.
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11298201
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1. A sterile drape suitable for placement over a phacoemulsification console display, comprising:
a first sheet comprising first opposing surfaces defined between a first top edge and a first bottom edge, a first length defined from the first top edge to the first bottom edge, and a first thickness defined between the first opposing surfaces, wherein the first sheet is clear;
a second sheet comprising second opposing surfaces defined between a second top edge and a second bottom edge, a second length defined from the second top edge to the second bottom edge, and a second thickness defined between the second opposing surfaces;
the first top edge coupled to the second top edge to define a downward-facing first pocket configured to be fittedly mounted to a top of the phacoemulsification console display, wherein the first length is longer than the second length and the first sheet is configured to drape over an interactive portion of the phacoemulsification console display; and
a third sheet comprising third opposing surfaces defined between a third top edge and a third bottom edge, a third length defined from the third top edge to the third bottom edge, and a third thickness defined between the third opposing surfaces, the third length and the second length are substantially the same,
wherein the second bottom edge is coupled to the third bottom edge, thereby defining an upward facing second pocket configured to receive at least a portion of both of a user's hands for positioning the second sheet and the third sheet to cover a back of the phacoemulsification console display with the upward facing second pocket.
2. The sterile drape of claim 1, wherein the first thickness is in a range of 1 to 3 mils.
3. The sterile drape of claim 2, wherein the first thickness is 1.25 mils.
4. The sterile drape of claim 1, wherein the second pocket is sized smaller than the first pocket.
5. The sterile drape of claim 1, wherein the second pocket is divided into multiple pockets by a seam.
6. The sterile drape of claim 1, wherein the second and third sheets are clear.
7. The sterile drape of claim 1, wherein the first, second and third sheets comprise blends of low density polyethylene resins.
8. The sterile drape of claim 1, wherein the first sheet forms an outer most layer of the sterile drape.
9. The sterile drape of claim 1, wherein aspects of the drape not configured to cover the interactive portion of the phacoemulsification console display are tinted or colored.
10. The sterile drape of claim 1, wherein the first top edge and the second top edge are coupled via a fold, wherein the fold has increased thickness relative to the first sheet.
11. A method of providing a sterile drape for covering a phacoemulsification console display, comprising:
providing the sterile drape in a sterile package, the sterile drape including: a first sheet with a first thickness defined between first opposing surfaces, a second sheet with a second thickness defined between second opposing surfaces, and a third sheet with a third thickness defined between third opposing surfaces;
enabling removal of the sterile drape from the package by a sterile user;
providing a downward facing first pocket fitting over the phacoemulsification console display, the first pocket formed by the first sheet being coupled to the second sheet with a first surface area of the first opposing surfaces being greater than a second surface area of the second opposing surfaces such that a first bottom edge of the first sheet extends beyond a second bottom edge of the second sheet; and
providing an upward facing second pocket formed by the second sheet being coupled to the third sheet, the second pocket configured to receive at least a portion of both of the sterile user's hands for positioning the second sheet and the third sheet to cover a back of the phacoemulsification console display with the second pocket, the second sheet has a first length and the third sheet has a second length substantially the same as the first length.
12. The method of claim 11, wherein the first sheet forms an outer most layer of the sterile drape.
13. The method of claim 11, wherein aspects of the drape not covering an interactive portion of the phacoemulsification console display are tinted or colored.
14. The method of claim 11, wherein wherein the first sheet and the second sheet are coupled via a fold, wherein the fold has increased thickness relative to the first sheet.
15. The method of claim 11, wherein the second pocket is divided into multiple pockets by a seam.
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15
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CROSS-REFERENCE TO RELATED CASES
The present application is a non-provisional of and claims priority to U.S. provisional application No. 61/791,603, filed on Mar. 15, 2013, which is hereby incorporated by reference in its entirety.
FIELD OF THE INVENTION
The present invention is generally related to methods, devices, and systems related to a sterile drape for a surgical display, such as a drape particularly for use during ophthalmic surgery.
BACKGROUND OF THE INVENTION
The optical elements of the eye include both a cornea (at the front of the eye) and a lens within the eye. The lens and cornea work together to focus light onto the retina at the back of the eye. The lens also changes in shape, adjusting the focus of the eye to vary between viewing near objects and far objects. The lens is found just behind the pupil, and within a capsular bag. This capsular bag is a thin, relatively delicate structure which separates the eye into anterior and posterior chambers.
With age, clouding of the lens or cataracts are fairly common. Cataracts can be treated by the replacement of the cloudy lens with an artificial lens. Phacoemulsification systems often use ultrasound energy to fragment the lens and aspirate the lens material from within the capsular bag. This may allow the capsular bag to be used for positioning of the artificial lens, and maintains the separation between the anterior portion of the eye and the vitreous humour in the posterior chamber of the eye.
For example, ultrasound from a phacoemulsification system may break up the lens and allow it to be drawn into a treatment probe with an aspiration flow, and a corresponding irrigation flow may be introduced into the eye so that the total volume of fluid in the eye does not change excessively. Conventionally, the phacoemulsification system includes a console and a fluidic cassette mounted on the console. The fluidic cassette is typically changed for each patient and cooperates with the console to provide fluid aspiration.
As such, a phacoemulsification system includes the aforementioned console, which typically provides one or more pumps, such as peristaltic and/or Venturi pumps, for acting on the tubing/fluidics of the cassette in order to provide the referenced irrigation and aspiration. Such a system also generally includes a user interface on the console for controlling and monitoring, among other surgical aspects, the pumps, ultrasound, irrigation and aspiration during surgery. Accordingly, the console generally provides a display, such as an LCD, LED, projection, or similar display, that provides information and status during a surgical procedure. Moreover, the display may serve as the interface mentioned above, at least in so called “touch screen” embodiments. Of course, other interfaces may also be available on the console, such as voice activated control, mechanical knobs and dials, and the like.
It is known that, due to the presence of the aforementioned display in a surgical environment, a sterile cover may be placed at least partially over the display. This cover may eliminate dust, and, in touch screen embodiments, may prevent contamination and/or surgical debris from passing to/from a user onto/from the screen. Such contamination or debris may affect console functionality, and/or may lead to adverse surgical consequences, such as infection.
Such a sterile cover for a phaco console display is disclosed, for example, in U.S. Pat. No. D567,245. However, current sterile drapes for a phaco display are applied as a simple cover, and thus risk breaking the sterile field during application to the phaco display. For example, because of the raised ridge on the display of the console of numerous phaco consoles presently in use, the sterile drape is applied “blindly” and hence subject to the risk of fingers touching the non-sterile top or back of the display ridge. Further, if the sterile field is broken during application of the display drape, the drape must be discarded and replaced, or the risk of contamination is appreciably increased.
Thus, the need exists for a drape for use on a display in a surgical environment that provides improved protection against breakage of the sterile field.
SUMMARY OF THE INVENTION
The present invention is and includes a sterile drape suitable for placement over a display of a phacoemulsification console. The drape includes a first sheet covering a front of the display, a second sheet tied/coupled, at an upper portion thereof, to an upper portion of the first sheet at a first fold at a top of the display, wherein the first fold provides a downward-facing first pocket for fittedly mounting to the top of the display, and a third sheet tied to a lower portion of the second sheet and thereby forming an upward facing second pocket for receiving at least a portion of a user's hand.
The present invention also includes a method of providing a sterile drape for covering a display of a phacoemulsification console. The method may include providing the sterile drape may be provided in a sterile package dedicated for a patient, enabling removal of the sterile drape from the package by a sterile user, providing a finger guard pocket in the sterile drape suitable for receiving fingers of the sterile user, and providing a fitted pocket to allow for fitting of the sterile drape over the display.
Thus, the present invention provides for a drape for use on a display in a surgical environment that provides improved protection against breakage of the sterile field.
BRIEF DESCRIPTION OF THE DRAWINGS
The present invention is best understood with reference to the following detailed description of the invention and the drawings, in which like reference numerals represent like elements, and in which:
FIG. 1 is a block diagram illustrating a patient and a phacoemulsification console;
FIG. 2 illustrates a phacoemulsification console;
FIGS. 3A, 3B, 3C, and 3D illustrate aspects of a surgical drape according to the disclosure; and
FIG. 4 is a flow diagram illustrating a method according to the disclosure.
DETAILED DESCRIPTION OF THE INVENTION
The figures and descriptions provided herein may be simplified to illustrate aspects of the described embodiments that are relevant for a clear understanding of the herein disclosed processes, machines, manufactures, and/or compositions of matter, while eliminating for the purpose of clarity other aspects that may be found in typical optical and surgical devices, systems, and methods. Those of ordinary skill may recognize that other elements and/or steps may be desirable or necessary to implement the devices, systems, and methods described herein. Because such elements and steps are well known in the art, and because they do not facilitate a better understanding of the disclosed embodiments, a discussion of such elements and steps may not be provided herein. However, the present disclosure is deemed to inherently include all such elements, variations, and modifications to the described aspects that would be known to those of ordinary skill in the pertinent art.
Referring to FIG. 1, a phaco system 10 for treating an eye E of a patient P generally includes an eye treatment probe handpiece 12 coupled to a console 14 by a cassette 100 mounted on the console 14. Handpiece 12 may include a handle for manually manipulating and supporting an insertable probe tip. The probe tip has a distal end which is insertable into the eye E, with one or more lumens in the probe tip allowing irrigation fluid to flow from the console 14 and/or cassette 100 into the eye E. Aspiration fluid may also be withdrawn through a lumen of the probe tip, with the console 14 and cassette 100 generally including a vacuum aspiration source, a positive displacement aspiration pump, or both to help withdraw and control a flow of surgical fluids into and out of eye E. As the surgical fluids may include biological materials that should not be transferred between patients, cassette 100 will often comprise a disposable (or alternatively, sterilizable) structure, with the surgical fluids being transmitted through flexible conduits 18 of the cassette that avoid direct contact in between those fluids and the components of console 14.
When a distal end of the probe tip of handpiece 12 is inserted into an eye E, for example, for removal of a lens of a patient with cataracts, an electrical conductor and/or pneumatic line (not shown) may supply energy from console 14 to a transmitter of the handpiece, a cutter mechanism, or the like. So as to balance the volume of material removed by the aspiration flow, an irrigation flow through handpiece 12 (or a separate probe structure) may also be provided, with both the aspiration and irrigations flows being controlled by console 14.
Controller 40 may include an embedded microcontroller and/or many of the components common to a personal computer, such as a processor, data bus, a memory, input and/or output devices. Such input devices may include a touch screen user interface/display 42. Display 42 will also typically display to a user the status of the aforementioned aspects, and/or other information related to the surgical procedure and/or the surgical environment.
Many components of console 14 may be found in or modified from known commercial phacoemulsification systems from Abbott Medical Optics Inc. of Santa Ana, Calif.; Alcon Manufacturing, Ltd. of Ft. Worth, Tex.; Bausch and Lomb of Rochester, N.Y.; and other suppliers. An exemplary console, having display/interface 42, is illustrated in FIG. 2.
The user interface/display 42 may thus allow for the controlling and monitoring of surgical aspects during surgery. The display 42 may be a LCD, LED, projection, or similar display, and may provide visual information during the surgical procedure. Moreover, the user interface/display may serve to receive user input that indicates control signals to controller 40, or that requests surgical information to be provided on the display, for example. Because the user interacts with the display/user interface during the surgical procedure, it is highly desirable that a sterile field be maintained with respect to the display 42.
In order to maintain a sterile field, the present invention provides a sterile drape for placement over the display 42 of console 14. The sterile drape 50 is illustrated in FIGS. 3A, 3B, 3C and 3D. The sterile drape 50 comprises a first sheet comprising first opposing surfaces defined between a first top edge and a first bottom edge, a first length defined from the first top edge to the first bottom edge, and a first thickness defined between the first opposing surfaces. The sterile drape 50 further comprises a second sheet comprising second opposing surfaces defined between a second top edge and a second bottom edge, a second length defined from the second top edge to the second bottom edge, and a second thickness defined between the second opposing surfaces. The sterile drape 50 further comprises a third sheet comprising third opposing surfaces defined between a third top edge and a third bottom edge, a third length defined from the third top edge to the third bottom edge, and a third thickness defined between the third opposing surfaces. As can be seen in FIGS. 3C and 3D, the third length and the second length are substantially the same. As shown, the sterile drape 50 includes a fold 50b, at the portion thereof that abuts the rear of display 42 in-situ, which acts as a finger guard during application of drape 50. That is, contrary to known drapes for phaco surgical console displays 42 that comprise a single fold 50a at the top portion thereof in order to allow securing over the top portion of display 42, the instant invention further includes a second fold 50b at the rear of the drape 50. The typical fold 50a has, as shown, the fold opening facing downward with respect to display 42, while the finger guard fold 50b comprises a fold opening facing upward at the rear of display 42. As such, finger guard fold 50b provides an upward facing “pocket” formed by the distal plane (with respect to display 42) of fold 50b and the proximal plane of fold 50b (which is also the rear plane of fold 50a as related to display 42). In embodiments, the larger opening of the drape may cover the display and or the display ridge on the console 42, and the second fold may create a pocket for receiving the fingers or hands of the sterile applicator, e.g. scrub nurse.
Current drapes provide seams on each side of the drape. The present invention, in order to form finger guard fold 50b, may use existing seaming to provide the finger guard, or may add additional seams. Additional seams might include, for example, stitched seams, adhesive-based seams, or the like. Additional seams can increase rigidity for improved handling and durability.
The foregoing embodiment may provide a single, large finger guard fold 50b for receiving a user's hands/fingers. Of course, one or more additional seams may be provided proximate to the center of finger guard fold 50b, such as to provide a pocket for each of the user's hands, individual pockets sized to accommodate fingers for increased control, pockets for a user's hands and additional pockets for placement of items, such as surgical devices, and the like.
The drape 50 may preferably be clear to allow for a user to see and interact with display 42, although aspects of the drape 50 not covering visual display portions of display 50 may be tinted or colored. The drape may be thin, such as to allow for indications by the user to pass readily through the sterile drape to interface 42. For example, each layer of the drape may have a thickness in the range of about 1 to about 3 mils, and, more particularly, may have a thickness of about 1.25 mils. Of course, aspects of the drape 50 that are not covering the visual display portion of display 42, such as folds 50a and 50b, may be of increased thickness, such as to provide increased strength and durability and to thereby avoid tearing. Further, the drape 50 may be formed of any known material suitable for the uses herein and having sufficient strength so as to provide the folds discussed herein, such as blends of low density polyethylene resins.
FIG. 4 is a flow diagram illustrating a method 400 according to the disclosure. As illustrated, the sterile drape may be provided in a sterile package dedicated for each patient P at step 402. Such a package may also include, for example, the aforementioned cassette for use with a particular patient. The drape may be removed from its packaging by a sterile user, such as a nurse/tech, and may then have folds 50a and 50b opened for use, at step 404. The sterile nurse/tech may then insert his/her fingers into the fold 50b at step 406. The drape 50 may then be placed over the console display at step 408 with no risk to sterile field breach.
It will be appreciated that the disclosed system and method of folding and seaming a sterile drape may be used in environments other than a phacoemulsification surgery. That is, the present invention may be employed anywhere a sterile drape is required or desirable for placement over an object or instrument.
The present invention has provided a sterile display cover, such as a plastic-type sheet that may protect the front surface of a touch screen/display, that may protect the user's palm side hand and the display ridge, and that may protect the sterile user's fingers
Although the invention has been described and illustrated in exemplary forms with a certain degree of particularity, it is noted that the description and illustrations have been made by way of example only. Numerous changes in the details of construction, combination, and arrangement of parts and steps may be made. Accordingly, such changes are intended to be included within the scope of the disclosure, the protected scope of which is defined by the claims.
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14193510
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johnson & johnson surgical vision, inc.
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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 12th, 2022 12:27PM
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Apr 12th, 2022 12:27PM
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Johnson & Johnson
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Health Care
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Pharmaceuticals & Biotechnology
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nyse:jnj
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Johnson & Johnson
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Apr 12th, 2022 12:00AM
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Mar 18th, 2020 12:00AM
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https://www.uspto.gov?id=US11298324-20220412
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Rapidly disintegrating gelatinous coated tablets
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The present invention relates to an improved gelatinous coated dosage form having two end regions coated with gelatinous materials and an exposed circumferential band. Openings are provided in at least the exposed band to reveal the core material. The invention also relates to methods for manufacturing such gelatinous coated dosage forms.
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11298324
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1. A dosage form, comprising:
a core, wherein the core comprises at least one active ingredient;
a subcoating, wherein the subcoating is applied to an exterior surface of the core;
a first gelatinous coating applied to a first end of the core;
a second gelatinous coating applied to a second end of the core;
wherein the first gelatinous coating and the second gelatinous coating are applied to the first end of the core and the second end of the core, respectively, after the subcoating is applied to the exterior surface of the core;
wherein the first gelatinous coating and the second gelatinous coating are separated from one another and form a gap through which the subcoating is exposed, wherein the gap has a width of equal to or greater than 7% to about 25% of an overall length of the core.
2. The dosage form according to claim 1, wherein the subcoating is applied to the entire exterior surface of the core.
3. The dosage form of claim 1, wherein the one or more active ingredients is selected from the group consisting of pseudoephedrine, phenylpropanolamine, chlorpheniramine, dextromethorphan, diphenhydramine, astemizole, terfenadine, fexofenadine, loratadine, desloratadine, cetirizine, mixtures thereof, and pharmaceutically acceptable salts, esters, isomers, and mixtures thereof.
4. The dosage form of claim 3, wherein the one or more active ingredients is selected from fexofenadine and pharmaceutically acceptable salts thereof.
5. A method for producing a dosage form comprising:
a) coating an exterior surface of a compressed tablet having two opposing ends with a subcoating to form a subcoated compressed tablet;
b) providing one end of the subcoated compressed tablet with a gelatinous material; and
c) providing a second end of the subcoated compressed tablet with a gelatinous material;
wherein the gelatinous coatings resulting from steps b) and c) form a gap that exposes an exterior surface of the subcoated compressed tablet from step a), wherein a width of said gap is equal to or greater than 7% to about 25% of an overall length of the core.
6. The method according to claim 5, wherein the subcoating is applied to the entire exterior surface of the compressed tablet.
7. The method of claim 5, wherein the one or more active ingredients is selected from the group consisting of pseudoephedrine, phenylpropanolamine, chlorpheniramine, dextromethorphan, diphenhydramine, astemizole, terfenadine, fexofenadine, loratadine, desloratadine, cetirizine, mixtures thereof, and pharmaceutically acceptable salts, esters, isomers, and mixtures thereof.
8. The method of claim 7, wherein the one or more active ingredients is selected from fexofenadine and pharmaceutically acceptable salts thereof.
9. A dosage form comprising:
a) a core having an exterior surface and first and second ends and comprising one or more active ingredients;
b) a subcoating, wherein the subcoating is applied to the exterior surface of the core to form a subcoated core;
c) a first gelatinous coating over at least part of the subcoated core; and
d) a second gelatinous coating over at least part of the subcoated core;
wherein the first and second gelatinous coatings are provided on said first and second ends of the subcoated core; wherein the total level of said first and second gelatinous coatings is from about 3 to about 10 weight percent based on the weight of the core; wherein said first and second gelatinous coatings form a gap through which the subcoated core is exposed; wherein the width of gap is from more than 7% to about 25% of the overall length of the subcoated core.
10. A method of treatment, comprising administering a dosage form, wherein said dosage form comprises:
a) a core having an exterior surface and first and second ends, wherein the core comprises one or more pharmaceutically active ingredients, cellulose or a derivative of cellulose, pregelatinized starch, and magnesium stearate;
b) a subcoating, wherein the subcoating is applied to the exterior surface of the core to form a subcoated core;
c) a first gelatinous coating over at least part of the subcoated core; and
d) a second gelatinous coating over at least part of the subcoated core;
wherein the first and second gelatinous coatings are provided on the first and second ends of the subcoated core; wherein the first and second gelatinous coatings form a gap through which the subcoated core is exposed, wherein the gap has a width of greater than 7% to about 25% of the length of the subcoated core, wherein the gap does not affect swallowability of the dosage form; and wherein the first and second gelatinous coatings each comprise gelatin.
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10
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RELATED APPLICATIONS
This application, which is a continuation application, claims priority of the benefit of U.S. patent application Ser. No. 16/116,216, filed Aug. 29, 2018; U.S. patent application Ser. No. 14/833,839, filed Aug. 24, 2015 (now U.S. Pat. No. 10,092,521); U.S. patent application Ser. No. 14/335,228, filed Jul. 18, 2014 (now U.S. Pat. No. 9,149,438); U.S. patent application Ser. No. 12/970,079, filed Dec. 16, 2010 (now U.S. Pat. No. 8,815,290); and U.S. patent application Ser. No. 10/756,528, filed Jan. 13, 2004 (now U.S. Pat. No. 7,879,354). The complete disclosures of the aforementioned U.S. patent applications are incorporated by reference in their entirety herein for all purposes.
The present invention relates to a dosage form comprising a tablet core having two ends. The tablet core, preferably in compressed form, is provided with a polymeric subcoating over its exterior surface. Further, the dosage form includes gelatinous coatings over both ends. The gelatinous endcaps are provided on opposing ends of the elongated tablet core or opposing sides of a round tablet core so that they do not meet and form a circumferential gap or band through which the subcoating is visible. Openings are provided in the dosage form that extend through the subcoat to the exterior surface of the elongated tablet or round tablet core. The openings are preferably provided only in the exposed gap of the subcoatings.
BACKGROUND OF THE INVENTION
Capsules have long been recognized as a preferred dosage form for the oral delivery of active ingredients, which may be in the form of powder, liquid or granules of different compositions, for delivery to the gastro-intestinal tract of a human. Advantages of capsules as a dosage form include the variety of shapes and color combinations (including different colored caps and bodies), enhancing their unique identification, their glossy elegant appearance, and their easy swallowability. One type of commonly used capsule is a two-piece hard shell capsule, typically made from gelatin, starch, or cellulose derivatives. The hard shell capsule typically comprises a longer body having an outside diameter, and a relatively shorter cap having an inside diameter that will just fit over the outside diameter of the body. The cap fits snugly over the body, creating an overlapping portion of the capsule.
In view of the tamperability of old-fashioned capsules made with hard shell capsule halves of different diameters which can be taken apart, steps have been taken since the 1980s, to manufacture capsule shells which, once assembled, cannot be disassembled without their destruction. One such example is the Capsugel CONI-SNAP® capsule, which has grooves that lock the cap and body together after the capsule has been filled. Another such example is the Parke-Davis KAPSEAL® capsule, in which the body and cap are sealed together using a band of gelatin. Although the sealing or banding of capsule shell halves has, in a large part, proven effective to at least make tampering evident to the consumer, some companies have preferred to manufacture solid dosage forms having densely compacted cores to further reduce the possibility of tampering.
One of the first types of film-coated elongated compressed tablets was referred to as a “caplet”. The caplet form offered enhanced swallowability over uncoated tablets due to its elongated shape and film-coated surface, similar to that of the capsule. It did not, however, enable the multi-colored glossy surface appearance of a capsule. While caplets are still popular today, the next generation of dosage forms, which offered all of these advantages of the capsule, comprised densely compacted cores that were coated with gelatin or similar glossy materials, typically in two parts having different colors. U.S. Pat. Nos. 5,089,270; 5,213,738; 4,820,524; 4,867,983 and 4,966,771 represent different approaches to providing a capsule-shaped product in the form of an elongated tablet having a coating, which provides the appearance and, therefore, the consumer acceptability of the previously popular capsule.
U.S. Pat. Nos. 5,415,868 and 5,317,849 disclose different manners by which either hard shell capsule halves can be shrink-wrapped onto a tablet (the '868 patent) or a tablet core covered at opposite ends with a soft gelatin capsule shell half and subsequently dried to simulate a capsule-like medicament (the '849 patent). U.S. Pat. No. 5,464,631 suggests that studies have also shown the functional importance to consumers of providing a capsule-appearing solid dosage form, which is multi-colored. The utilization of two colors functionally identifies the type of medication as well as provides a capsule-appearing product with a psychologically perceived medicinal efficacy. Aesthetically, also, consumers apparently prefer the attractive appearance of multi-colored capsules to single colored capsules.
Thus, there has been a rush by the pharmaceutical industry to provide over-the-counter gelatinous coated dosage forms which simulate the appearance of capsules and which have a variety of multiple colors which identify the type of medication provided so that the consumer can readily identify, for example, if the product is a particular type of analgesic or whether it includes antihistamines or other active ingredients in combination with analgesics. Such solid dosage forms have preferably been in the shape of an elongated tablet, and are identified as gelcaps when a solid elongated core is covered with a gelatinous covering or geltabs where the core is in the shape of a round tablet with a gelatinous coating.
The present invention furthers these earlier advances by producing an improved gelcap or geltab having faster disintegration and/or dissolution times relative to the commercially available gelatinous coated products.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is an enlarged isometric view of a compressed core in the form of an elongated tablet having a generally cylindrical shape, called a “gelcap core”.
FIG. 2 is an enlarged isometric view of an intermediate dosage form.
FIG. 3 is a final dosage form of the present invention.
DETAILED DESCRIPTION OF INVENTION
As used herein, the term “dosage form” applies to any solid object, semi-solid, or liquid composition designed to contain a specific pre-determined amount (dose) of a certain ingredient, for example an active ingredient as defined below. Suitable dosage forms may be pharmaceutical drug delivery systems, including those for oral administration, buccal administration, rectal administration, topical or mucosal delivery, or subcutaneous implants, or other implanted drug delivery systems; or compositions for delivering minerals, vitamins and other nutraceuticals, oral care agents, flavorants, and the like. Preferably the dosage forms of the present invention are considered to be solid, however they may contain liquid or semi-solid components. In a particularly preferred embodiment, the dosage form is an orally administered system for delivering a pharmaceutical active ingredient to the gastro-intestinal tract of a human. In another preferred embodiment, the dosage form is an orally administered “placebo” system containing pharmaceutically inactive ingredients, and the dosage form is designed to have the same appearance as a particular pharmaceutically active dosage form, such as may be used for control purposes in clinical studies to test, for example, the safety and efficacy of a particular pharmaceutically active ingredient.
As used herein the term “tablet” refers to a solid form prepared by compaction of powders on a tablet press, as well known in the pharmaceutical arts. Tablets can be made in a variety of shapes, including round, or elongated, such as flattened ovoid or cylindrical shapes. As used herein, a “gelcap core” refers to one type of elongated, generally cylindrical or capsule-shaped tablet having straight or slightly bowed sides, and a generally circular cross-section, and having a length to diameter ratio from about 2 to about 5, e.g. from about 2.5 to about 3.5, say about 3.
A caplet is one type of elongated tablet covered by a film coating. There is shown in FIG. 1 a core 10 in the shape of an elongated tablet having two ends 12 at opposing sides of a longitudinal axis. A bellyband 14 occurs along the
longitudinal circumference where the tablet is in contact with the die walls during compaction.
The core can have any number of pharmaceutically acceptable tablet shapes. Tablet is meant to encompass shaped compacted dosage forms in the broadest sense. An elongated tablet is a type of tablet having an elongated shape. One type of gelcap core shown in FIG. 1 has a generally circular cross section that generally tapers from the mid-section to a tip or end region. For purposes of this application, the longitudinal axis passes through the center of both ends of the gelcap core.
The core (or substrate) may be any solid or semi-solid form. The core may prepared by any suitable method, for example the core be a compressed dosage form, or may be molded. As used herein, “substrate” refers to a surface or underlying support, upon which another substance resides or acts, and “core” refers to a material that is at least partially enveloped or surrounded by another material. For the purposes of the present invention, the terms may be used interchangeably: i.e. the term “core” may also be used to refer to a “substrate.” Preferably, the core comprises a solid, for example, the core may be a compressed or molded tablet, hard or soft capsule, suppository, or a confectionery form such as a lozenge, nougat, caramel, fondant, or fat based composition. In certain other embodiments, the core may be in the form of a semi-solid or a liquid in the finished dosage form.
In one embodiment, the core has one or more major faces. The core may be in a variety of different shapes. For example, in one embodiment the core may be in the shape of a truncated cone. In other embodiments the core may be shaped as a polyhedron, such as a cube, pyramid, prism, or the like; or may have the geometry of a space figure with some non-flat faces, such as a cone, cylinder, sphere, torus, or the like. Exemplary core shapes that may be employed include tablet shapes formed from compression tooling shapes described by “The Elizabeth Companies Tablet Design Training Manual” (Elizabeth Carbide Die Co., Inc., p. 7 (McKeesport, Pa.) (incorporated herein by reference) as follows (the tablet shape corresponds inversely to the shape of the compression tooling):
Shallow Concave.
Standard Concave.
Deep Concave.
Extra Deep Concave.
Modified Ball Concave. Standard
Concave Bisect. Standard
Concave Double Bisect.
Standard Concave European Bisect.
Standard Concave Partial Bisect.
Double Radius.
Bevel & Concave.
Flat Plain.
Flat-Faced-Beveled Edge (F.F.B.E.).
F.F.B.E. Bisect.
F.F.B.E. Double Bisect.
Ring.
Dimple.
Ellipse.
Oval.
Capsule.
Rectangle.
Square.
Triangle.
Hexagon.
Pentagon.
Octagon.
Diamond.
Arrowhead.
Bullet.
Barrel.
HalfMoon.
Shield.
Heart. Almond.
House/Home Plate.
Parallelogram.
Trapezoid.
Figure 8/Bar Bell.
Bow Tie.
Uneven Triangle.
Core 10 is pressed of a blend of suitable active ingredients and excipients which may be either their natural color, including white, or can be conventionally colored as desired to provide a conventional, or elongated-shaped core of any desired color.
The dosage form of the present invention preferably contains one or more active ingredients. Suitable active ingredients broadly include, for example, pharmaceuticals, minerals, vitamins and other nutraceuticals, oral care agents, flavorants and mixtures thereof. Suitable pharmaceuticals include analgesics, anti-inflammatory agents, antiarthritics, anesthetics, antihistamines, antitussives, antibiotics, anti-infective agents, antivirals, anticoagulants, antidepressants, antidiabetic agents, antiemetics, antiflatulents, antifungals, antispasmodics, appetite suppressants, bronchodilators, cardiovascular agents, central nervous system agents, central nervous system stimulants, decongestants, oral contraceptives, diuretics, expectorants, gastrointestinal agents, migraine preparations, motion sickness products, mucolytics, muscle relaxants, osteoporosis preparations, polydimethylsiloxanes, respiratory agents, sleep-aids, urinary tract agents and mixtures thereof.
Suitable flavorants include menthol, peppermint, mint flavors, fruit flavors, chocolate, vanilla, bubblegum flavors, coffee flavors, liqueur flavors and combinations and the like.
Examples of suitable gastrointestinal agents include antacids such as calcium carbonate, magnesium hydroxide, magnesium oxide, magnesium carbonate, aluminum hydroxide, sodium bicarbonate, dihydroxyaluminum sodium carbonate; stimulant laxatives, such as bisacodyl, cascara sagrada, danthron, senna, phenolphthalein, aloe, castor oil, ricinoleic acid, and dehydrocholic acid, and mixtures thereof; H2 receptor antagonists, such as famotadine, ranitidine, cimetadine, nizatidine; proton pump inhibitors such as omeprazole or lansoprazole; gastrointestinal cytoprotectives, such as sucraflate and misoprostol; gastrointestinal prokinetics, such as prucalopride, antibiotics for H. pylori, such as clarithromycin, amoxicillin, tetracycline, and metronidazole; antidiarrheals, such as diphenoxylate and loperamide; glycopyrrolate; antiemetics, such as ondansetron, analgesics, such as mesalamine.
Examples of suitable polydimethylsiloxanes, which include, but are not limited to dimethicone and simethicone, are those disclosed in U.S. Pat. Nos. 4,906,478, 5,275,822, and 6,103,260, the contents of each is expressly incorporated herein by reference. As used herein, the term “simethicone” refers to the broader class of polydimethylsiloxanes, including but not limited to simethicone and dimethicone.
In one embodiment of the invention, at least one active ingredient may be selected from bisacodyl, famotadine, ranitidine, cimetidine, prucalopride, diphenoxylate, loperamide, lactase, mesalamine, bismuth, antacids, and pharmaceutically acceptable salts, esters, isomers, and mixtures thereof.
In another embodiment, at least one active ingredient is selected from analgesics, anti-inflammatories, and antipyretics, e.g. non-steroidal anti-inflammatory drugs (NSAIDs), including a) propionic acid derivatives, e.g. ibuprofen, naproxen, ketoprofen and the like; b) acetic acid derivatives, e.g. indomethacin, diclofenac, sulindac, tolmetin, and the like; c) fenamic acid derivatives, e.g. mefenamic acid, meclofenamic acid, flufenamic acid, and the like; d) biphenylcarbodylic acid derivatives, e.g. diflunisal, flufenisal, and the like; e) oxicams, e.g. piroxicam, sudoxicam, isoxicam, meloxicam, and the like; f) cyclooxygenase-2 (COX-2) selective NSAIDs; and g) pharmaceutically acceptable salts of the foregoing.
In one particular embodiment, at least one active ingredient is selected from propionic acid derivative NSAID, which are pharmaceutically acceptable analgesics/non-steroidal anti-inflammatory drugs having a free —CH(CH3)COOH or —CH2CH2COOH or a pharmaceutically acceptable salt group, such as —CH(CH3)COO—Na+ or CH2CH2COO—Na+, which are typically attached directly or via a carbonyl functionality to a ring system, preferably an aromatic ring system.
Examples of useful propionic acid derivatives include ibuprofen, naproxen, benoxaprofen, naproxen sodium, fenbufen, flurbiprofen, fenoprofen, fenbuprofen, ketoprofen, indoprofen, pirprofen, carpofen, oxaprofen, pranoprofen, microprofen, tioxaprofen, suprofen, alminoprofen, tiaprofenic acid, fluprofen, bucloxic acid, and pharmaceutically acceptable salts, derivatives, and combinations thereof. In one embodiment of the invention, the propionic acid derivative is selected from ibuprofen, ketoprofen, flubiprofen, and pharmaceutically acceptable salts and combinations thereof. In another embodiment, the propionic acid derivative is ibuprofen, 2-(4-isobutylphenyl) propionic acid, or a pharmaceutically acceptable salt thereof, such as the arginine, lysine, or histidine salt of ibuprofen. Other pharmaceutically acceptable salts of ibuprofen are described in U.S. Pat. Nos. 4,279,926, 4,873,231, 5,424,075 and 5,510,385, the contents of which are incorporated by reference.
In another particular embodiment of the invention, at least one active ingredient may be an analgesic selected from acetaminophen, acetyl salicylic acid, ibuprofen, naproxen, ketoprofen, flurbiprofen, diclofenac, cyclobenzaprine, meloxicam, rofecoxib, celecoxib, and pharmaceutically acceptable salts, esters, isomers, and mixtures thereof.
In another particular embodiment of the invention, at least one active ingredient may be selected from pseudoephedrine, phenylpropanolamine, chlorpheniramine, dextromethorphan, diphenhydramine, astemizole, terfenadine, fexofenadine, loratadine, desloratadine, cetirizine, mixtures thereof and pharmaceutically acceptable salts, esters, isomers, and mixtures thereof.
In another particular embodiment, at least one active ingredient is an NSAID and/or acetaminophen, and pharmaceutically acceptable salts thereof.
The active ingredient or ingredients are present in the dosage form in a therapeutically effective amount, which is an amount that produces the desired therapeutic response upon oral administration and can be readily determined by one skilled in the art. Indetermining such amounts, the particular active ingredient being administered, the bioavailability characteristics of the active ingredient, the dosing regimen, the age and weight of the patient, and other factors must be considered, as known in the art. Typically, the dosage form comprises at least about 1 weight percent, preferably, the dosage form comprises at least about 5 weight percent, e.g. about 20 weight percent of a combination of one or more active ingredients. In one preferred embodiment, the core comprises a total of at least about 25 weight percent (based on the weight of the core) of one or more active ingredients.
The active ingredient or ingredients may be present in the dosage form in any form. For example, one or more active ingredients may be dispersed at the molecular level, e.g. melted or dissolved, within the dosage form, or may be in the form of particles, which in turn may be coated or uncoated. If an active ingredient is in form of particles, the particles (whether coated or uncoated) typically have an average particle size of about 1-2000 microns. In one preferred embodiment, such particles are crystals having an average particle size of about 1-300 microns. In another preferred embodiment, the particles are granules or pellets having an average particle size of about 50-2000 microns, preferably about 50-1000 microns, most preferably about 100-800 microns.
In certain embodiments, at least a portion of one or more active ingredients may be optionally coated with a release modifying coating, as known in the art. This advantageously provides an additional tool for modifying the release profile of active ingredient from the dosage form. For example, the core may contain coated particles of one or more active ingredients, in which the particle coating confers a release modifying function, as is well known in the art. Examples of suitable release modifying coatings for particles are described in U.S. Pat. Nos. 4,173,626; 4,863,742; 4,980,170; 4,984,240; 5,86,497; 5,912,013; 6,270,805; and 6,322,819. Commercially available modified release coated active particles may also be employed. Accordingly, all or a portion of one or more active ingredients in the core may be coated with a release-modifying material.
In embodiments in which it is desired for at least one active ingredient to be absorbed into the systemic circulation of an animal, the active ingredient or ingredients are preferably capable of dissolution upon contact with a dissolution medium such as water, gastric fluid, intestinal fluid or the like.
In one embodiment, the dissolution characteristics of at least one active ingredient meets USP specifications for immediate release tablets containing the active ingredient. For example, for acetaminophen tablets, USP 24 specifies that in pH 5.8 phosphate buffer, using USP apparatus 2 (paddles) at 50 rpm, at least 80% of the acetaminophen contained in the dosage form is released therefrom within 30 minutes after dosing, and for ibuprofen tablets, USP 24 specifies that in pH 7.2 phosphate buffer, using USP apparatus 2 (paddles) at 50 rpm, at least 80% of the ibuprofen contained in the dosage form is released therefrom within 60 minutes after dosing. See USP 24, 2000 Version, 19-20 and 856 (1999). In embodiments in which at least one active ingredient is released immediately, the immediately released active ingredient is preferably contained in the shell or on the surface of the shell, e.g. in a further coating surrounding at least a portion of the shell.
In another embodiment, the dissolution characteristics of one or more active ingredients are modified: e.g. controlled, sustained, extended, retarded, prolonged, delayed and the like. In a preferred embodiment in which one or more active ingredients are released in a modified manner, the modified release active or actives are preferably contained in the core. As used herein, the term “modified release” means the release of an active ingredient from a dosage form or a portion thereof in other than an immediate release fashion, i.e., other than immediately upon contact of the dosage form or portion thereof with a liquid medium. As known in the art, types of modified release include delayed or controlled. Types of controlled release include prolonged, sustained, extended, retarded, and the like. Modified release profiles that incorporate a delayed release feature include pulsatile, repeat action, and the like. As is also known in the art, suitable mechanisms for achieving modified release of an active ingredient include diffusion, erosion, surface area control via geometry and/or impermeable or semi-permeable barriers, and other known mechanisms.
In certain preferred embodiments, the core 10 is subsequently covered with a subcoating 12 that can be any number of medicinally acceptable coverings. The use of subcoatings is well known in the art and disclosed in, for example, U.S. Pat. No. 5,234,099, which is incorporated by reference herein. Any composition suitable for film-coating a tablet may be used as a subcoating according to the present invention. Examples of suitable subcoatings are disclosed in U.S. Pat. Nos. 4,683,256, 4,543,370, 4,643,894, 4,828,841,4,725,441,4,802,924, 5,630,871, and 6,274,162, which are all incorporated by reference herein. Suitable compositions for use as subcoatings include those manufactured by Colorcon, a division of Berwind Pharmaceutical Services, Inc., 415 Moyer Blvd., West Point, Pa. 19486 under the tradename “OPADRY®” (a dry concentrate comprising film forming polymer and optionally plasticizer, colorant, and other useful excipients). Additional suitable subcoatings include one or more of the following ingredients: cellulose ethers such as hydroxypropylmethylcellulose, hydroxypropy 1 cellulose, and hydroxyethylcellulose; polycarbohydrates such as xanthan gum, starch, and maltodextrin; plasticizers including for example, glycerin, polyethylene glycol, propylene glycol, dibutyl sebecate, triethyl citrate, vegetable oils such as castor oil, surfactants such as Polysorbate-SO, sodium lauryl sulfate and dioctyl-sodium sulfosuccinate; polycarbohydrates, pigments, and opacifiers.
In one embodiment, the subcoating comprises from about 2 percent to about 8 percent, e.g. from about 4 percent to about 6 percent of a water-soluble cellulose ether and from about 0.1 percent to about 1 percent, castor oil, as disclosed in detail in U.S. Pat. No. 5,658,589, which is incorporated by reference herein. In another embodiment, the subcoating comprises from about 20 percent to about 50 percent, e.g., from about 25 percent to about 40 percent of HPMC; from about 45 percent to about 75 percent, e.g., from about 50 percent to about 70 percent of maltodextrin; and from about 1 percent to about 10 percent, e.g., from about 5 percent to about 10 percent of PEG 400. The dried subcoating typically is present in an amount, based upon the dry weight of the core, from about 0 percent to about 5 percent. The subcoat is typically provided by spraying in a coating pan or fluidized bed to cover the tablet in a conventional manner. The subcoating composition is optionally tinted or colored with colorants such as pigments, dyes and mixtures thereof.
In one embodiment, subcoating 12 is initially applied to the entire exterior surface of core 10. Subcoating 12 can be applied as a clear, transparent coating such that the core can be seen. The choice is dictated by the preference of the manufacturer and the economics of the product. In a preferred embodiment, a commercially available pigment is included the subcoating composition in sufficient amounts to provide an opaque film having a visibly distinguishable color relative to the core.
An unexpected improvement resulting from the modified gel dipping process has been a change in subcoating requirements. The conventional amount of subcoating has been the use of sufficient amounts of subcoating for at least a 3.5%, typically at least a 4% weight gain (i.e. the weight of the coated core is 3.5 to 4% more than the weight of the uncoated core). Conventional gel-dipping processes required a subcoating weight gain of at least 3.5% to prevent unacceptable bubbling of the dip-coating (referred to herein as the gelatinous coating) and other processing problems. It has now been discovered that for dosage forms coated according to the present invention (in which the more than one non-overlapping gelatinous coatings are applied) the amount, as measured by weight gain, of subcoating can be reduced to not more than about 3%, e.g. not more than about 2.75%, or not more than about 2.5%, or not more than about 2.1%, say to about 2% weight gain and still produce acceptable gelatin coated dosage forms. Weight gain calculations are well known to those skilled in the art.
FIG. 2 illustrates an intermediate dosage form 20 having two ends 12 with gelatinous coatings 24 that do not abut or overlap one another. The gelatinous coatings 24 are separated from one another and create a gap 26. Subsequent to applying subcoating 22 onto core 10, both ends 12 of core 10 are covered with gelatinous coatings 24, preferably containing a colorant or coloring agent. The opposing ends 12 of dosage form 20 can be covered with clear gelatinous materials or gelatinous materials having the same color as core 10, the same color as the subcoating 22, a different color from the core 10 and/or subcoating 22, and may be the same or different from one another. Coloring of the gelatinous coating 24 may be the result of incorporating a suitable ink, dye or pigment into the gelatinous materials. In the preferred embodiment, sufficient pigment is employed to create an opaque colored coating.
In certain preferred embodiments of the invention the dosage form further comprises one, or more preferably a plurality of openings provided in the exposed portion of the subcoating. The openings may be of any shape and size, and may optionally be arranged in a pattern. In embodiments in which the openings are made by laser ablation, the width or diameter of the smallest opening is typically at least I-2 times the wavelength of light provided by the laser employed. At least a portion of the openings may be large enough to be seen with the unaided human eye, ranging in width or diameter from about 400 nanometers to as much as any dimension of the exposed subcoating. Typically, such openings will have minimum width or diameter of at least about 500 nanometers, e.g. at least about 700 nanometer, or at least about 70 microns.
Typically visible openings will have a maximum width or diameter of not more than the width of the tablet, or not more than the width of the exposed subcoating band, for example not more than about 6.5 millimeters, or not more than about 3.5 millimeters, say not more than about 2.5 millimeters. Alternatively, some or all of the openings may be microscopic in size, ranging from about 1 to less than about 400 nanometers in width or diameter. In embodiments in which some or all of the openings are invisible to the unaided human eye, a plurality of openings may be arranged in a pattern that creates perforations or weak spots in the film, which facilitate disintegration. While it is not critical to the invention that the initial openings be large enough to allow the influx of water, particularly when water-soluble subcoatings are employed, it should be noted that it has been found that for certain preferred embodiments, an opening size of about 0.030 inches in width or diameter will allow water to pass therethrough.
For purposes of this application, a gelatinous material is defined to be a material that, when applied by dip coating, produces a film coating having a surface gloss comparable to gelatin coatings. “Surface gloss” as used herein, shall refer to amount of light reflectance as measured at a sixty (60) degree incident angle using the method set forth in the examples. Preferably, the gelatinous coating has a surface gloss greater than about 150, more preferably greater than about 200.
Gelatins have traditionally served as a primary dip-coating material. Hence, the phrase “gelatinous” material. Recently, further work has been done to expand the range of materials capable of providing the desired glossy finish that contain substantially no gelatins.
Gelatin is a natural, thermogelling polymer. It is a tasteless and colorless mixture of derived proteins of the albuminous class, which is ordinarily soluble in warm water. Two types of gelatin—Type A and Type B—are commonly used. Type A gelatin is a derivative of acid-treated raw materials. Type B gelatin is a derivative of alkali-treated raw materials. The moisture content of gelatin, as well as its Bloom strength, composition and original gelatin processing conditions, determine its transition temperature between liquid and solid. Bloom is a standard measure of the strength of a gelatin gel, and is roughly correlated with molecular weight. Bloom is defined as the weight in grams required to move a half-inch diameter plastic plunger 4 mm into a 6.67% gelatin gel that has been held at 10° C. for 17 hours.
In certain embodiments of the invention, the level of gelatin is from about 20% to about 50% by weight of the gelatinous material. In one particular such embodiment, the gelatin is a blend of gelatins in which a first portion has a Bloom value of about 275 and a second portion has a Bloom value of about 250 Bloom. In certain embodiment the level of gelatin in the dipping dispersion is from about 25% to about 45%, e.g. about 30 to about 40%, say about 33% by weight of the dipping dispersion. In such embodiments, the level of gelatin is from about 99% to about 99.9% by weight of the finished gelatinous coating.
Suitable water soluble, substantially gelatin-free, film forming compositions for dip coating tablets or manufacturing capsules via a dip molding process are described in copending application, Ser. No. 10/122,999, filed Apr. 12, 2002, published as US 2003-0070584 A I, which is incorporated herein by reference. One such gelatinous composition comprises, consists of, and/or consists essentially of a film former such as a cellulose ether, e.g., hydroxypropylmethylcellulose; and a thickener, such as a hydrocolloid, e.g., xanthan gum or carrageenan. In another embodiment, the gelatinous composition comprises, consists of, and/or consists essentially of a film former such as a modified starch selected from waxy maize starch, tapioca dextrin, and derivatives and mixtures thereof; a thickener selected from sucrose, dextrose, fructose, maltodextrin, polydextrose, and derivatives and mixtures thereof; and a plasticizer, e.g., polyethylene glycol, propylene glycol, vegetable oils such as castor oil, glycerin, and mixtures thereof.
In yet another embodiment, the gelatinous composition comprises, consists of, and/or consists essentially of a film former such as a cellulose ether, e.g., hydroxypropyl methylcellulose; and optionally a plasticizer, such as vegetable oils, e.g., castor oil; and may optionally be substantially free of thickeners such as hydrocolloids, e.g. xanthan gum. In yet another embodiment, the gelatinous composition comprises, consists of, and/or consists essentially of a film former such as a cellulose ether, e.g., hydroxypropylmethylcellulose; an extender, such as polycarbohydrates, e.g. maltodextrin; and optionally a plasticizer, such as glycols, e.g., polyethylene glycol; and may optionally be substantially free of thickeners such as hydrocolloids, e.g. xanthan gum.
An alternative gelatinous material comprises, consists of, and/or consists essentially of: a) carrageenan; and b) sucralose, as described in copending application Ser. No. 10/176,832, filed Jun. 21, 2002, published as US 2003-0108607 A1, which is incorporated herein by reference.
A further alternative gelatinous composition is comprised of, consisting of, and/or consisting essentially of: a) a film former selected from the group consisting of waxy maize starch, tapioca dextrin, derivative of a waxy maize starch, derivative of a tapioca dextrin, and mixtures thereof; b) a thickener selected from the group consisting of sucrose, dextrose, fructose, and mixtures thereof; and c) a plasticizer, wherein the composition possesses a surface gloss of at least 150 when applied via dip coating to a substrate.
Another embodiment is directed to a gelatinous composition comprised of, consisting of, and/or consisting essentially of: a) a hydroxypropyl starch film former; b) a thickener selected from the group consisting of kappa carrageenan, iota carrageenan, maltodextrin, gellan gum, agar, gelling starch, and derivatives and mixtures thereof; and c) a plasticizer, wherein the composition possesses a surface gloss of at least 150 when applied via dip coating to a substrate. Both embodiments are described in copending application Ser. No. 10/122,531, filed Apr. 15, 2002, published as US 2003-0072731 A1, which is incorporated herein by reference.
A further gelatinous composition is comprised of, consisting of, and/or consisting essentially of a film forming composition comprised of, consisting of, and/or consisting essentially of, based upon the total dry solids weight of the composition: a) from about 10 percent to about 70 percent of a film former comprised of a polymer or copolymer of (meth)acrylic acid or a derivative thereof, or a mixture of the polymer or copolymer of (meth)acrylic acid or a derivative thereof; b) from about 2 percent to about 20 percent of a primary plasticizer comprised of a paraben; and c) from about 1 percent to about 50 percent of a secondary plasticizer selected from the group consisting of polyvinylpyrrolidone, polyethylene glycol 300, polyethylene glycol 400, pharmaceutically acceptable salts thereof, and mixtures thereof; wherein the composition possesses a surface gloss of at least 150 gloss units when applied via dip coating to a substrate.
Another embodiment is a gelatinous composition comprised of, consisting of, and/or consisting essentially of, based upon the total dry solids weight of the composition: a) from about 10 percent to about 70 percent of a film former comprised of a polymer or copolymer of (meth)acrylic acid or a derivative thereof, or a mixture of the polymer or copolymer of (meth)acrylic acid or a derivative thereof; and b) from about 3 percent to about 70 percent of a plasticizer selected from the group consisting of triacetin, acetylated monoglyceride, rape oil, olive oil, sesame oil, acetyltributyl citrate, glycerin sorbitol, diethyloxalate, diethylmalate, diethyl fumarate, dibutyl succinate, diethylmalonate, dioctylphthalate, dibutylsuccinate, triethylcitrate, tributylcitrate, glyceroltributyrate, propylene glycol, polyethylene glycols, hydrogenated castor oil, fatty acids, substituted triglycerides and glycerides, methylparaben, ethyl paraben, propylparaben, butyl paraben, polyvinylpyrrolidone, polyethylene glycol 300, polyethylene glycol 400, and pharmaceutically acceptable salts thereof and mixtures thereof, wherein the composition possesses a surface gloss of at least about 150 gloss units when applied via dip coating to a substrate. Each of the foregoing (meth)acrylic (co)polymer compositions is described in copending application Ser. No. 10/211,139, filed Aug. 2, 2002, which is incorporated herein by reference.
As used herein, “substantially gelatin-free” shall mean less than about 1 percent, e.g. less than about 0.5 percent, of gelatin in the composition, and “substantially free of thickeners” shall mean less than about percent, e.g. less than about 0.01 percent, of thickeners in the composition.
One preferred process of manufacturing intermediate dosage form 20 begins by compressing or compacting a tablet core 10 into the desired shape of the medicament. As used herein, “compact, compacting, or compacted” and “compress, compressing, or compressed” may be used interchangeably to describe the commonly used process of compacting powders into tablets via conventional pharmaceutical tableting technology as well known in the art. One typical such process employs a rotary tablet machine, often referred to as a “press” or “compression machine”, to compact the powders into tablets between upper and lower punches in a shaped die. This process produces a core having two opposed faces, formed by contact with an upper and lower punch, and having a bellyband formed by contact with a die wall. Typically such compressed tablets will have at least one dimension of the major faces at least as long as the height of the bellyband area between the major faces. Alternately, processes have been disclosed in the prior art to enable the “longitudinal compression” of tablet cores. When longitudinally compressed tablets are employed, it has been found that an aspect ratio (height between the major faces to width or diameter of the major faces) from about 1.5 to about 3.5, e.g. about 1.9 facilitates handling.
Tablets are typically compacted to a target weight and “hardness”. Hardness is a term used in the art to describe the diametrical breaking strength as measured by conventional pharmaceutical hardness testing equipment, such as a Schleuniger Hardness Tester. In order to compare values across differently sized tablets, the breaking strength is normalized for the area of the break (which may be approximated as tablet diameter times thickness). This normalized value, expressed in kp/cm2, is sometimes referred in the art as “tablet tensile strength.” A general discussion of tablet hardness testing is found in Leiberman et al., Pharmaceutical Dosage Forms—Tablets, Volume 2, 2nd ed., Marcel Dekker Inc., 1990, pp. 213-217, 327-329, which is incorporated by reference herein.
Gelatinous coatings 24 are provided by inserting one end 12 of core 10 into collets, immersing the exposed end 12 into a selected gelatinous material, and repeating the steps with respect to the opposing end 12 of core 10. One method for practicing such a process is described in U.S. Pat. No. 5,234,099, which is incorporated herein by reference. The gelatinous coatings 24 are provided in such a way that gelatinous coatings 24 do not meet, and in fact, form a visually discernible gap or band 26 around the non-longitudinal circumference of core 10. Alternatively, when producing a tablet form, the gap would be provided along and around the bellyband. In the preferred embodiment, subcoating 22 is exposed to the environment due to the gap or band region 26. Generally, the minimum attainable gap width is governed by machine processing tolerances. The current positioning tolerance for conventional gel-dipping equipment is about +/−0.015 inches. Results of sensory evaluation indicate that for the gap width range of 0.088 to 0.135 inches, the slipperiness of the dosage form not effected, and panelists cannot detect a height transition, i.e. “step-up” from the subcoating band to the gel-dipped ends.
An alternative means for applying gelatinous coating 24 is by shrinking wrapping opposing gelatin caps onto the substrate. Shrink wrap process technology is known and described in U.S. Pat. Nos. 6,126,767, 5,415,868, 5,824,338, 5,089,270, 5,213,738, all assigned to Perrigo and incorporated by reference herein and U.S. Pat. Nos. 5,317,849, 5,609,010, 5,460,824, 6,080,426, 6,245,350, 5,464,631, 5,795,588 and 5,511,361.
In certain preferred embodiments, intermediate dosage form 20 produced in any of the methods described above is subsequently subjected to a mechanical or laser drilling process. A transversely excited atmosphere (TEA) laser is a preferred device for this step, particularly when used in conjunction with known tablet conveying devices, such as those commercially available from Hartnett.
In one embodiment, subcoated and short-dipped gelcaps are fed into a primary hopper, from which they flow via a chute into the original hopper of a “Delta” printer, available from R. W. Hartnett Company. From the original hopper, the gelcaps fall in an upright orientation, i.e. the longitudinal axis is oriented vertically, into carrier links, and are conveyed upwards at about a 45-degree angle.
The gelcaps in the carrier links are conveyed between rubber impression rolls, which can be set at an “open” position, or a “printing” position. The gelcaps in the carrier links are then conveyed through a “drilling section”, in which a laser beam is rapidly pulsed, as often as every 10 microseconds, to coincide with the gelcaps passing therethrough.
The source of the laser beam is an “Impact 2015” Transverse Excited Atmosphere C02 laser available from Lumonics Inc. The laser initially emits a 1-inch square beam having 4 Joules of energy towards a turning mirror that redirects the beam 90 degrees (upward) into a series of turning mirrors and a spherical field lens that reduces the beam from 1 inch by 1 inch to about 0.75 inch by 0.75 inch. The focused beam continues towards another turning mirror and then passes through a stainless steel mask with openings that allows only a portion of the beam to continue. The actual configuration of series the lenses and mirrors is not essential to the invention and is dictated primarily by space and cost considerations.
After passing through the mask, the patterned beam is redirected by a series of turning mirrors into a final focusing lens that reduces the size of the patterned beam about 5 times. The reduced, patterned beam ultimately strikes the gelcaps passing through the “drilling section”, causing the subcoating to be ablated and form shaped openings in a pattern determined by the mask. Adjusting the height of the final turning mirror can modify the striking position of the patterned beam. Mirrors and lenses are commercially available from companies, such as LightMachinery, Inc.
FIG. 3 illustrates final dosage form 30 having ends 12 coated with gelatinous coatings 24 that form a gap 26. Openings 32 are provided in gap 26 that exposes an overcoated exterior surface of core 10. In one embodiment, the mechanical drill or laser produces at least one, preferably, a plurality of openings or holes 32 entirely through subcoating 22 to expose core 10. In another embodiment, the mechanical drill or laser produces at least one, preferably a plurality of openings 32 through subcoating 22, one gelatinous coating 24, both gelatinous coatings 24, or combinations thereof. The preferred embodiment provides a plurality of openings 32 only through subcoating 22. In certain optional embodiments, openings 32 are large enough to be visible to the naked human eye. In this case, those skilled in the art can appreciate the advantage of using subcoating 22 and/or gelatinous coating 24 having a color that is different from that of overcoated core 10 in order to highlight the presence of openings 32.
The color difference can result from inclusion of a colorant or coloring agent in subcoating 22 and/or gelatinous coating 24. In an alternative embodiment, the colorant or coloring agent is incorporated into compacted material used to make core 10, while subcoating 22 and/or gelatinous coatings 24 have one or more different colors from core 10.
A still further embodiment is a final dosage form 30 having openings 32 through subcoating 22 and/or one or more gelatinous coatings 24 that are not visually highlighted. Such an embodiment has subcoating 22 and, optionally, one or more gelatinous coatings 24 that are transparent. Alternatively, subcoating 22 and, optionally, one or more gelatinous coatings 24 have the same or similar color as overcoated core 10. An uncolored core 10 has a generally white color, which can be matched by the use of various white pigments, such as titanium dioxide. Alternatively, core 10 can be modified to include a color other than white, which also can be matched by the colorants or coloring agents provided in or over subcoating 22 and/or the gelatinous coatings 24.
An additional embodiment can be a final dosage form 30 that includes printed material meant to appear as holes or openings 32. Such an embodiment would not exhibit all of the advantages of the present invention, though having a visually similar appearance.
Gap or band region 26 can be off-center or centered on final dosage form 30. In one embodiment, as to the elongated tablet shaped core 10, gap 26 has a width of about 80 to 120 mils. Gap 26 can alternatively be expressed in terms of the percentage of the length of the elongated tablet as measured along its longest axis. Gap 26 can be characterized in such a case as being about 5% to about 33%, e.g. about 7% to about 25%, say about 10% to about 15%, the length of the elongated tablet. As the gap becomes too small, the level of improved dissolution diminishes, the area for providing openings to the core is reduced, and the visual effects of the gaps disappear. Additionally, as the gap becomes too large, some of the consumer preferences, such as swallowability, for the gelcap dosage forms may be compromised. The percentage of the surface of the core covered with the gelatinous material would be inverse of the percentage of the gap width for the tablet.
The medicaments manufactured according to the present invention, therefore, provide the desired shape, swallowability and appearance for a solid dosage form that substantially eliminates the tamperability of the medicament. Further, the discontinuous gel coating and modified subcoating provide improved dissolution and disintegration properties, but surprisingly does not compromise swallowability of the dosage form.
A still further embodiment is a final dosage form 30 having a subcoating 22 at a level of not more than about 3.0%, e.g. not more than about 2.5%, or not more than about 2.1%, say about 2% relative to the weight of the uncoated core; and/or one or more gelatinous coatings 24 that form a gap 26, wherein the width of gap 26 is at least about 5% of the overall length of the uncoated core, and wherein gelatinous coatings 24 are substantially free of visible “bubble” defects. A substantial limitation with previous generations of gel-dipped dosage forms having overlapping or abutting gelatinous coatings was the occurrence of bubble defects. Without wishing to be bound by theory, it is believed that air from the compacted core migrated through the subcoating towards the surface of the dipped gelatinous coating, causing a visible defect. Previous attempts to reduce the subcoating level below about 3.5% based on the weight of the uncoated compacted core resulted in unacceptable levels of bubble defects.
It has surprisingly been found that the non-continuous gelatinous coatings of the present invention enable elegant finished dip-coated dosage forms at subcoating levels less than 3.6%, e.g. not more than about 3.0%, or not more than about 2.5%, or not more than about 2.1%, say not more than about 2%, based on the weight of the uncoated core, wherein said dip-coated dosage form is substantially free of visible bubble defects. As used herein, substantially free of bubble defects shall mean not more than 4 tablets per hundred, e.g. not more than 1 tablet per hundred, say not more than one tablet per thousand, have visible defects greater than or equal to 2 mm in diameter, and not more than 13 tablets per hundred, e.g. not more than 3 tablets per hundred, or not more than 1 tablet per hundred, say not more than 2 tablets per thousand have visible defects less than 2 mm in diameter.
It will become apparent to those skilled in the art that various modifications to the preferred embodiments of the invention can be made by those skilled in the art without departing from the spirit or scope of the invention as defined by the appended claims.
EXAMPLES
Example 1 (Comparative) Commercially Available Caplets
Acetaminophen (500 milligrams) film-coated tablets (Extra Strength TYLENOL® Caplets) are obtained from the manufacturer, McNeil Consumer & Specialty Pharmaceuticals division of McNeil-PPC, Inc. for the purpose of comparative dissolution testing (see Example 7).
Example 2 (Comparative) Preparation of Conventional Gelcaps
2A.) Preparation of Uncoated Compacted Cores for Conventional Gelcaps
Compacted cores are prepared in accordance with the procedure set forth in Example 1 of U.S. Pat. No. 5,658,589 (“589 patent”), which is incorporated by reference herein.
2B) Preparation of Subcoating Dispersion for Conventional Gelcaps
An aqueous dispersion containing the ingredients set forth in Table A is prepared by mixing the HPMC and castor oil into half of the water at slow mixer speed and a temperature 80° C. in a stainless steel jacketed vacuum tank under ambient conditions, then continuing to mix at “fast” speed for 15 minutes. The second half of the water is then added to the tank, with continued mixing at “slow” speed. The solution is then deaerated by vacuum, and cooled to a temperature of 35° C., with continued mixing at “slow” speed. Mixing is then discontinued, vacuum released, and the solution is transferred to a pressure pot for spraying onto the tablet cores.
TABLE A
Aqueous Dispersion Subcoating Composition
for Comparison Gelcaps
Ingredient
Parts*
HPMC (2910, 5 mPs) from Dow Chemical Company
61.2
under the tradename, “Methocel E-5”
Castor oil
0.24
Water
620.0
Total Coating Solution
681.44
% solids in coating solution
9%
*expressed in terms of parts by weight unless otherwise noted
2C) Preparation of Subcoated Cores for Conventional Gelcaps
The coating dispersion is then applied onto the compressed tablets via spraying in accordance with the procedure set forth in the examples of the '589 patent. The coating dispersion is applied to the compressed cores in amount sufficient to produce an increased weight of an average of 4.5% relative to the weight of the subcoating-free compressed cores.
2D) Preparation of Colorless Gelatin-Based Dipping Dispersion
The ingredients in the table below are used to prepare a 1200 liter batch of colorless gelatin-based dipping solution. Purified water at a temperature of about 85° C. is added to a jacketed vacuum-equipped mix tank. Sodium lauryl sulfate (SLS) is added to the water, followed by Gelatin 275 Bloom and Gelatin 250 Bloom while mixing. The temperature of the mixture after addition of the gelatin blend is approximately 57° C. The gelatin solution is mixed for 10 minutes, and then deaerated under vacuum for 4 hours.
Percent w/w
Percent w/w
Ingredient
of dispersion
of gelcap
Purified Water USP
67.01
—
Sodium Lauryl Sulfate
0.03
0.006
Gelatin NF (275 Bloom Skin)
10.15
1.8
Gelatin NF (250 Bloom Bone)
22.80
4.2
2E) Preparation of Yellow Gelatin-Based Dipping Solution
96 kg of colorless gelatin-based dipping solution prepared according to example 2D is transferred to a jacketed mix tank. 4.30 kg of Opatint Yellow DD2125 is added. The solution is mixed at low speed for 4 hours (at ambient pressure) to deaerate while the tank is maintained at a solution temperature of about 55° C.
2F) Preparation of Red Gelatin-Based Dipping Solution
96 kg of colorless gelatin-based dipping solution prepared according to example 2D is transferred to a jacketed mix tank. 4.30 kg of Opatint Red DD1761 is added. The solution is mixed at low speed for 4 hours (at ambient pressure) to deaerate while the tank is maintained at a solution temperature of about 55° C.
2G.) Gel Dipping of Subcoated Cores for Conventional Gelcaps
Subcoated cores prepared according to the method of examples 2A-2C, above, are placed (in a plastic tote) at the tablet inlet station of the gel dipping apparatus described in U.S. Pat. No. 5,234,099, which is incorporated herein by reference in its entirety.
Yellow gel-dipping solution prepared according to example 2E herein is transferred to a first gelatin feed tank. Red gel-dipping solution prepared according to example 2F herein is transferred to a second gelatin feed tank. Material from each gelatin feed tank is allowed to flow into a separate dip pan. A first end of each subcoated core is dipped into the yellow gel-dipping solution, and a second end of each subcoated core is dipped into the red gel-dipping solution, according to the method and using the apparatus described in U.S. Pat. No. 5,234,099. The gel-dipping operation is carried out using the following operating limits:
Supply air temperature: 26-32° C.
Supply air dew point: 6-12° C.
Supply air volume: 9450-10550 CFM
Dip area temperature 15-25° C.
Dip area air volume 230-370 CFM
Dip pan Temperatures (red and yellow): 44-46° C.
Yellow gel dipping solution viscosity: 525-675 cps
Red gel dipping solution viscosity: 675-825 cps
Depth of dip to cutline (yellow): 0.406″-0.437″
Depth of dip to cutline (red): 0.375″-0.406″
Moisture content (% loss on drying at 150° C.) of finished gelcaps: 2.0-3.0%
Example 3: Preparation of Subcoated Gelcap Cores at 3.0 and 4.5% Coating Levels
Compressed cores are prepared according to the method set forth in Example 1A herein. 316 kg of the compressed cores are loaded into a 48-inch diameter side vented coating pan (Accela Cota) equipped with 4 suitable [model JAU available from Spraying Systems Inc.] 2-fluid spray guns at a gun to tablet bed distance of approximately 12 inches.
An aqueous subcoating dispersion is prepared according to the method of Example 2B. A 160 kg quantity of subcoating dispersion 2B is metered into a pressurized coating dispersion tank equipped with a mixer and vacuum. 1.17 kg of Opatint Red DD1761 is added with mixing at 700 rpm for 10 minutes. The red subcoating dispersion is deaerated for 10 minutes under vacuum.
The red subcoating dispersion is then sprayed onto the compressed cores in an amount (107.4 kg) sufficient to produce an increased weight of an average of 3.0% relative to the weight of the uncoated compressed cores. A 20 kg sample of the 3.0% subcoated cores is removed. The 3.0% subcoated cores are referred to herein as sample “3A”. The remainder of the panload is then further coated with an additional 53.7 kg of subcoating dispersion, to obtain a total increased weight of an average of 4.5% relative to the weight of the uncoated compressed cores. The 4.5% subcoated cores are referred to herein as sample “3B”.
The red subcoating dispersion is mixed at 300 rpm throughout the spraying process. The coating process is conducted, using the following parameters:
Coating dispersion tank pressure: 74.0-74.5 PSI
Atomizing Air pressure: 71.9-73.9 PSI
Dispersion spray rate: 0.63-0.66 kg/minute
Supply Air Volumetric Flow Rate: 4190-4319 cubic feet per minute
Coating pan pressure: −0.25-0.30 in. We
Supply air temperature: 69.3-80.4° C.
Exhaust air Temperature: 62.3° C.-64.6° C.
Pan speed (first 40 kg of solution): 4.11 rpm
Pan speed (after first 40 kg of solution): 6.92 rpm
Example 4: Preparation of Subcoated Gelcap Cores at 2.0% Coating Level
316 kg of compressed cores prepared according to the method set forth in Example 1A herein are loaded into a 48-inch diameter side vented coating pan (Accela Cota) equipped with 4 suitable [model JAU, available from Spraying Systems Inc.] 2-fluid spray guns at a gun to tablet bed distance of approximately 12 inches.
An aqueous subcoating dispersion is prepared according to the method of Example 2B. A 160 kg quantity of subcoating dispersion 2B is metered into a pressurized coating dispersion tank equipped with a mixer and vacuum. 2.63 kg of Opatint Red DD1761 is added with mixing at 700 rpm for 10 minutes. The red subcoating dispersion is deaerated for 10 minutes under vacuum.
The red subcoating dispersion is then sprayed onto the compressed cores in an amount (72.2 kg) sufficient to produce an increased weight of an average of 2.0% relative to the weight of the uncoated compressed cores. The 2.0% subcoated cores are referred to herein as sample “4”.
The red subcoating dispersion is mixed at 300 rpm throughout the spraying process. The coating process is conducted, using the following parameters:
Coating dispersion tank pressure: 75.0 PSI
Atomizing Air pressure: 70.2-70.6 PSI
Dispersion spray rate: 0.62-0.65 kg/minute
Supply Air Volumetric Flow Rate: 4179-4182 cubic feet per minute
Coating pan pressure: −0.15-0.26 in. We
Supply air temperature: 70.8-81.1° C.
Exhaust air Temperature: 61.5° C.-62.7° C.
Pan speed (first 40 kg of solution): 3.92 rpm
Pan speed (after first 40 kg of solution): 6.82 rpm
Example 5: Gel Dipping of Subcoated Cores to Prepare the Dosage Form of the Invention
SA) 96 kg of colorless gelatin-based dipping solution prepared according to example 2D is transferred to a jacketed mix tank. 4.3 kg of Opatint Blue DD-10516 is added. The solution is mixed at low speed for 4 hours (at ambient pressure) to deaerate while heating the tank to maintain a solution temperature of about 55° C.
Blue gel-dipping solution is transferred to a first gelatin feed tank. Blue gel-dipping solution is transferred to a second gelatin feed tank. Material from each gelatin feed tank is allowed to flow into a separate dip pan.
5B) Subcoated cores prepared according to Example 4 (2.0% subcoating level), are transferred to the hopper of the gel-dipping apparatus described in U.S. Pat. No. 5,234,099.
A first end of each subcoated core is dipped into blue gel-dipping solution, and a second end of each subcoated core is dipped into the second blue gel-dipping solution, according to the method and using the apparatus described in U.S. Pat. No. 5,234,099. The gel-dipping operation is carried out using the following operating limits:
Supply air temperature: 28° C.
Supply air dew point: 9° C.
Supply air volume: 10013 CFM
Dip area temperature 21° C.
Dip area air volume 300 CFM
Dip pan Temperatures (1st and 2nd): 44.6-44.9° C.
Blue (1) gel-dipping solution viscosity: 680 cps
Blue (2) gel-dipping solution viscosity: 793 cps
Depth of dip to cutline (first blue end): 0.320″-0.333″
Depth of dip to cutline (second blue end): 0.320″-0.335″
Moisture content (% loss on drying at 150° C.) of finished gelcaps: 2.0%
Gel-dipped coating level (% by weight of subcoated cores): 5.3%
5C) The “short-dipped” gelcaps are then transferred to the hopper of a Hartnett Delta Printer equipped with a TEA-Laser, as described previously herein. A plurality of openings is ablated into the exposed subcoating portion in a pattern, as shown in FIG. 3.
Example 6: Gel-Dipping of Subcoated Cores from Example 3 (4.5% Subcoating Level)
6A) Subcoated cores prepared according to example 3 are dipped in blue gel-dipping solution according to the method of Examples 5A&B herein, leaving a band of exposed red subcoating.
6B) A plurality of openings is ablated into the exposed subcoating portion in a pattern, according to the method of Example 5C herein.
Example 7
Comparative Dissolution Data for 500 mg Acetaminophen Solid Dosage Forms
Time (minutes):
′3
6
9
12
15
30
Ex. 1 Caplet
82
97
99
100′
100
100
Ex. 2A Uncoated Core
81
99
100
101
101
101
Ex, 2C Subcoated Core (4.5%)
4
84
99
101
101
102
Ex. 2G Gelcap
0
51
94
99
100
100
Ex. 3B Subcoated Core (4.5%)
17
90
98
99
99
100
Ex. 6A Short dipped from ex. 3B
0
47
91
95
97
98
Ex. 6B: 6A with laser openings
63
95
98
99
99
100
Ex. 4 Subcoated Core (2.0%)
77
96
98
99
99
99
Ex. 5B Short dipped from Ex. 4
40
89
96
97
98
99
Ex. 5C: 5B with laser openings
80
95
97
98
98
99
Example 8: Sensory Evaluation of Gap Width
Short-dipped gelcaps prepared according to example 5B, were sorted according to the width of the exposed subcoating band, and grouped into the following categories:
min bandwidth
max bandwidth
Sample
(inches)
(inches)
c
0.08766
0.09766
A
0.09846
0.10051
E
0.1011
0.11535
D
0.11206
0.13454
B
0.14008
0.16916
One sample from each gapwidth category was then evaluated by each of 11 panelists, and rated according to the following criteria:
1=Cannot detect a texture difference between exposed subcoating band and gel-dipped ends
2=some texture difference if scrutinized, but slipperiness of dosage form not effected, and cannot detect a height transition, i.e. “step-up” from the subcoating band to the gel-dipped ends
3=definite perceptible texture transition between gel-dipped ends and exposed subcoating band
4=Can feel a difference in height, i.e. the “step up” from the subcoating band to the gel-dipped ends
Results of the evaluation were as follows:
P1
P2
P3
P4
P5
P6
P7
P8
pg
P10
P11
AvQ
Stdev
c
1
1
1
1
1
1
2
2
2
2
2
1.45
0.52
1
1
1
1
1
1
2
2
2
2
1
1.36
0.50
E
1
1
1
1
1
1
2
2
1
2
2
1.36
0.50
D
1
1
1
1
1
2
2
2
2
1
2
1.45
0.52
B
1
1
1
1
2
2
3
3
2
1
1
1.64
0.81
Results of this evaluation indicate that for the gap width range of 0.088 to 0.135 inches, the slipperiness of the dosage form not effected, and panelists cannot detect a height transition, i.e. “step-up” from the subcoating band to the gel-dipped ends.
Example 9—Surface Gloss Measurement of Coated Tablets
Tablets described below were tested for surface gloss using an instrument available from TriCor Systems Inc. (Elgin, Ill.) under the tradename, “Tri-Cor Model 805A/806H Surface Analysis System” generally in accordance with the procedure described in “TriCor Systems WGLOSS 3.4 Model 805A/806H Surface Analysis System Reference Manual” (1996), which is incorporated by reference herein, except as modified below.
The instrument utilized a CCD camera detector, employed a flat diffuse light source, compared tablet samples to a reference standard, and determined average gloss values at a sixty (60) degree incident angle. During operation, the instrument generated a gray-scale image, wherein the occurrence of brighter pixels indicated the presence of more gloss at that given location. The instrument also incorporated software that utilized a grouping method to quantify gloss, i.e., pixels with similar brightness were grouped together for averaging purposes.
The “percent full scale” or “percent ideal” setting (also referred to as the “percent sample group” setting), was specified by the user to designate the portion of the brightest pixels above the threshold that will be considered as one group and averaged within that group. “Threshold”, as used herein, is defined as the maximum gloss value that will not be included in the average gloss value calculation. Thus, the background, or the non-glossy areas of a sample were excluded from the average gloss value calculations. The method disclosed in K. Fegley and C. Vesey, “The Effect of Tablet Shape on the Perception of High Gloss Film Coating Systems”, which is available at www.colorcon.com as of 18 Mar. 2002 and incorporated by reference herein, was used in order to minimize the effects resulting from different tablet shapes, and thus report a metric that was comparable across the industry. (Selected the 50% sample group setting as the setting which best-approximated analogous data from tablet surface roughness measurements).
After initially calibrating the instrument using a calibration reference plate (190-228; 294 degree standard; no mask, rotation 0, depth 0), a standard surface gloss measurement was then created using gel-coated caplets available from McNeil-PPC, Inc. under the tradename, “Extra Strength Tylenol Gelcaps.” The average gloss value for a sample of 112 of such gel-coated caplets was then determined, while employing the 25 mm full view mask (190-280), and configuring the instrument to the following settings:
Rotation: 0
Depth: 0.25 inches
Gloss Threshold: 95
% Full Scale: 50%
Index of Refraction: 1.57
The average surface gloss value for the reference standard was determined to be 269, using the 50% ideal (50% full scale) setting. Commercially available gel coated tablets were tested in accordance with the above procedure. The results are summarized in table below.
TABLE
Gloss values of commercially available coated tablets
Excedrin **
Excedrin **
Excedrin **
Extra Strength
Extra Strength
Aspirin free
Migraine
Migraine
Tylenol
Tylenol
Caplets
Geltab
Geltab
Geltabs *
Geltabs *
Product
(red)
(green side)
(white side)
(yellow side)
(red side)
Type of coating
Sprayed film
Gelatin enrobed
Gelatin enrobed
Dipped
Dipped
No. of tablets
40
10
10
112
112
tested
Gloss Value(%
119
270
264
268
268
ideal at 50)
* Available from McNeil-PPC, Inc.
** Available from Bristol-Myers, Squibb, Inc.
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16823058
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johnson & johnson consumer inc.
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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.
|
Open
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|
|
Apr 12th, 2022 12:27PM
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Apr 12th, 2022 12:27PM
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Johnson & Johnson
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Health Care
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Pharmaceuticals & Biotechnology
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nyse:jnj
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Johnson & Johnson
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Apr 5th, 2022 12:00AM
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May 11th, 2020 12:00AM
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https://www.uspto.gov?id=US11291538-20220405
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Ophthalmic apparatus with corrective meridians having extended tolerance band
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The embodiments disclosed herein include improved toric lenses and other ophthalmic apparatuses (including, for example, contact lens, intraocular lenses (IOLs), and the like) and associated method for their design and use. In an embodiment, an ophthalmic apparatus (e.g., a toric lens) includes one or more angularly-varying phase members comprising a diffractive or refractive structure, each varying the depths of focus of the apparatus so as to provide an extended tolerance to misalignment of the apparatus when implanted in an eye. That is, the ophthalmic apparatus establishes an extended band of operational meridian over the intended correction meridian.
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11291538
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1. A rotationally-tolerant intraocular lens (IOL), the intraocular lens comprising a multi-zonal optic body comprising one or more angularly-varying phase members that each includes an optimized combination of angularly and zonally diffractive phase structure located across one or more optical zones to apply power at one or more correcting meridian, wherein each of the one or more angularly-varying phase members applies the power at a given correcting meridian and vary an extended depth of focus to a plurality of nearby points of focus to provide an extended tolerance to misalignment of the intraocular lens when implanted in an eye,
the multi-zonal optic body forming a first angularly-varying phase member having a peak cylinder power centered at a first correcting meridian, the first angularly-varying phase member at the peak cylinder power being configured to direct light, at the first correcting meridian, to a first point of focus on the retina, wherein at angular positions nearby to the first correcting meridian, the angularly-varying phase member varies, at each optical zone, and is configured to direct light to points of focus nearby to the first point of focus such that the multi-zonal optic body, when rotational offset from the peak cylinder power, directs light from the nearby points of focus to the first point of focus, thereby establishing an extended band of operational meridians over the first correcting meridian.
2. The intraocular lens of claim 1,
wherein the multi-zonal lens body forms the angularly-varying phase member, wherein a height profile T1(r, θ) for each meridian θ is defined as:
T1(r,θ)=t1(r)|COS2(θ)|+t2(r)|SIN2(θ)|
where t1(r) and t2(r) are the added power for each zone.
3. The intraocular lens of claim 2, wherein the multi-zonal lens body comprises at least four optical zones, the at least four optical zones forming an angularly varying efficiency quadric optics.
4. The intraocular lens of claim 3, wherein the angularly-varying phase members, collectively, form a pattern that is expressed as
r
(
θ
)
=
2
·
n
·
s
(
θ
)
·
λ
A
(
θ
)
,
where r(θ) is the contour radius for the given meridian added power A(θ), wavelength λ, zone number n, and the scaling value s(θ), all at meridian θ.
5. The intraocular lens of claim 1, wherein the angularly-varying phase member spans an optical zone defined by a polynomial-based surface coincident at a plurality of meridians having distinct cylinder powers, wherein each of the plurality of meridians is uniformly arranged on the optical zone for a same given added diopter of power up to 1.0 D.
6. The intraocular lens of claim 5, wherein differences among each continuously uniformly distributed contour line, at a given IOL plane, associated with a given meridian of the plurality of meridians is less than about 0.6 D (diopters).
7. The intraocular lens of claim 5, wherein the polynomial-based surface is characterized by a series of weighted cosine-based functions.
8. The intraocular lens of claim 1, wherein the one or more angularly-varying phase members each spans a first optical zone defined by a freeform-polynomial surface area coincident with one or more distinct cylinder powers, wherein the freeform-polynomial surface area is defined as a mathematical expression comprising a combination of one or more polynomial expressions each having a distinct complex orders.
9. The intraocular lens of claim 8, wherein at least one of the one or more polynomial expressions are selected from the group consisting of a Chebyshev polynomial and a Zernike polynomial.
10. The intraocular lens of claim 8, wherein the freeform-polynomial surface area establishes the extended band of operational meridian across a range selected from the group consisting of about ±4 degrees, about ±5 degrees, about ±6 degrees, about ±7 degrees, about ±8 degrees, about ±9 degrees, about ±10 degrees, about ±11 degrees, about ±12 degrees, about ±13, degrees, about ±14 degrees, and about ±15 degrees.
11. The intraocular lens of claim 8, wherein the freeform-polynomial surface area has a second height profile T(x,y) on a first base height profile, the second height profile being defined as:
T(x,y)=Σ{c(i,j)*cos(i*arccos(t))*cos(j*arccos(t))}
where c(i, j) is a coefficient based on i and j, which are each integers, x and y are spatial locations on the freeform-polynomial surface area, and t is a normalized parameter having values between −1.0 and 1.0.
12. The intraocular lens of claim 11, wherein the coefficients c(i, j) or c2(i2, j2) are a function of local coordinates that puts accumulated high surface amplitude to area of non-functional retinal area.
13. The intraocular lens of claim 11, wherein the coefficients c(i, j) or c2(i2, j2) are a function of local coordinates that accounts for irregular corneal shape.
14. The intraocular lens of claim 8, wherein the one or more optical zones includes the first optical zone and a second optical zone, wherein the second optical zone is defined by a second freeform-polynomial surface region characterized and defined by a second polynomial, wherein the second freeform-polynomial surface area has a third height profile T2(x,y) superimposed on a first height profile (e.g. a base or typical aspheric height profile), the third height profile being defined as:
T2(x,y)=Σ{c2(i2,j2)*cos(i2*arccos(t2))*cos(j2*arccos(t2))}
where c2(i, j) is a coefficient based on i2 and j2, which are each integers, x and y are spatial locations on the second freeform-polynomial surface area and has values between −1.0 and 1.0, and t2 is a normalized parameter having values between −1.0 and 1.0.
15. The intraocular lens of claim 12, wherein the first freeform-polynomial surface area and the second freeform-polynomial surface area each comprises a monofocal lens, a bifocal lens, a multi-focal lens, or an extended range of vision lens.
16. The intraocular lens of claim 1, wherein the angularly-varying phase member is formed of a refractive structure.
17. The intraocular lens of claim 1, wherein the angularly-varying phase member is formed of a diffractive structure.
18. The intraocular lens of claim 1, wherein an offset of each meridian of the plurality of meridians of about 10 degrees causes a MTF (modulation transfer function) measure change of less than 10% at 30 cycles per degree (cpd).
19. The intraocular lens of claim 1, wherein the multi-zonal optic body forms a second angularly-varying phase member having a second peak cylindrical power centered at a second correcting meridian, the second angularly-varying phase member at the second peak cylinder power being configured to direct light to a second point of focus on the retina, wherein at angular positions nearby to the first meridian, wherein the second angularly-varying phase member varies along meridian nearby to the second point of focus such that the multi-zonal optic body, when rotational offset from the second peak cylinder power, directs light from the nearby points of focus to the second point of focus.
20. The intraocular lens of claim 1, wherein the intraocular lens comprises an intraocular toric lens.
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20
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RELATED APPLICATIONS
This application is a divisional of and claims priority to U.S. patent application Ser. No. 15/467,963, filed Mar. 23, 2017, which claims priority to, and the benefit of, U.S. Provisional Appl. No. 62/312,321, filed Mar. 23, 2016; U.S. Provisional Appl. No. 62/312,338, filed Mar. 23, 2016; and 62/363,428, filed Jul. 18, 2016, each of which is incorporated by reference herein in its entirety.
TECHNICAL FIELD
This application is directed to lenses for correcting astigmatism, including providing increased tolerance for lens placement during implantation.
BACKGROUND
Ophthalmic lenses, such as spectacles, contact lenses and intraocular lenses, may be configured to provide both spherical and cylinder power. The cylinder power of a lens is used to correct the rotational asymmetric aberration of astigmatism of the cornea or eye, since astigmatism cannot be corrected by adjusting the spherical power of the lens alone. Lenses that are configured to correct astigmatism are commonly referred to as toric lenses. As used herein, a toric lens is characterized by a base spherical power (which may be positive, negative, or zero) and a cylinder power that is added to the base spherical power of the lens for correcting astigmatism of the eye.
Toric lenses typically have at least one surface that can be described by an asymmetric toric shape having two different curvature values in two orthogonal axes, wherein the tonic lens is characterized by a “low power meridian” with a constant power equal to the base spherical power and an orthogonal “high power meridian” with a constant power equal to the base spherical power plus the cylinder power of the lens. Intraocular lenses, which are used to replace or supplement the natural lens of an eye, may also be configured to have a cylinder power for reducing or correcting astigmatism of the cornea or eye.
Existing toric lenses are designed to correct astigmatic effects by providing maximum cylindrical power that precisely matches the cylinder axis. Haptics are used to anchor an intraocular lens to maintain the lenses at a desired orientation once implanted in the eye. However, existing toric lenses themselves are not designed to account for misalignment of the lens that may occur during the surgical implantation of the lens in the eye or to account for unintended post-surgical movement of the lens in the eye.
Accordingly, it would be desirable to have intraocular lenses that are tolerant to misalignments.
SUMMARY
The embodiments disclosed herein include improved toric lenses and other ophthalmic apparatuses (including, for example, contact lens, intraocular lenses (IOLs), and the like) and associated method for their design and use. In an embodiment, an ophthalmic apparatus (e.g., a toric lens) includes one or more angularly-varying phase members comprising a diffractive or refractive structure, each varying the depths of focus of the apparatus so as to provide an extended tolerance to misalignment of the apparatus when implanted in an eye. That is, the ophthalmic apparatus establishes a band of operational meridian over the intended correction meridian.
Several embodiments of ophthalmic apparatus with extended tolerance astigmatism features are disclosed, each configured to establish the extended band of operational meridian.
In an aspect, an ophthalmic apparatus is disclosed. The ophthalmic apparatus includes an angularly-varying phase member configured to direct light, at a first meridian, to a first point of focus, wherein at angular positions nearby to the first meridian, the angularly-varying phase member is configured to direct light to points of focus nearby to the first point of focus such that rotational offsets of the angularly-varying phase member from the first meridian directs light from the nearby points of focus to the first point of focus, thereby establishing an extended band of operational meridian.
In some embodiments, the ophthalmic apparatus includes a multi-zonal lens body having a plurality of optical zones, wherein the multi-zonal lens body forms the angularly-varying phase member, wherein a height profile T1(r, θ) for each meridian θ is defined as: T1(r, θ)=t1(r)|COS 2(θ)|+t2(r)|SIN 2(θ)|, where t1(r) and t2(r) are the added power for each zone.
In some embodiments, the angularly-varying phase member and other angularly-varying phase members of the apparatus, collectively, forms a butterfly pattern.
In some embodiments, the multi-zonal lens body includes at least four optical zones, the at least four optical zones forming an angularly varying efficiency quadric optics (e.g., wherein the angularly varying efficiency trifocal optics comprises a first angularly varying phase member, e.g., a first refractive angularly varying phase member, at the first meridian; a second angularly varying phase member, e.g., a second refractive angularly varying phase member, at a second meridian; a third angularly varying phase member, e.g., a third refractive angularly varying phase member, at a third meridian; and a fourth refractive angularly varying phase member, e.g., a fourth refractive angularly varying phase member, at a fourth meridian).
In some embodiments, the angularly-varying phase members, collectively, form a butterfly pattern that is expressed as
r
(
θ
)
=
2
·
n
·
s
(
θ
)
·
λ
A
(
θ
)
,
where r(θ) is the contour radius for the given meridian added power A(θ), wavelength λ, zone number n, and the scaling value s(θ), all at meridian θ.
In some embodiments, the angularly phase member spans an optical zone defined by a polynomial-based surface coincident at a plurality of meridians having distinct cylinder powers, wherein each of the plurality of meridians is uniformly arranged on the optical zone for a same given added diopter of power up to 1.0 D.
In some embodiments, differences among each continuously uniformly distributed contour line, at a given IOL plane, associated with a given meridian of the plurality of meridians is less than about 0.6 D (diopters).
In some embodiments, the polynomial-based surface is characterized by a series of weighted cosine-based functions.
In some embodiments, the angularly phase member spans an optical zone defined by a freeform-polynomial surface area (e.g., as area having one or more refractive surfaces) coincident with one or more distinct cylinder powers, wherein the freeform-polynomial surface area is defined as a mathematical expression comprising a combination of one or more polynomial expressions (e.g., Chebyshev-based polynomial expression, Zernike-based polynomial expression, etc.) each having a distinct complex orders.
In some embodiments, at least one of the one or more polynomial expressions are selected from the group consisting of a Chebyshev polynomial and a Zernike polynomial.
In some embodiments, the freeform-polynomial surface area establishes the extended band of operational meridian across a range selected from the group consisting of about ±4 degrees, about ±5 degrees, about ±6 degrees, about ±7 degrees, about ±8 degrees, about ±9 degrees, about ±10 degrees, about ±11 degrees, about ±12 degrees, about ±13, degrees, about ±14 degrees, and about ±15 degrees.
In some embodiments, the freeform-polynomial surface area has a second height profile T(x,y) (e.g., an extra height profile having an associated cylinder power) on a first base height profile (e.g., a base or typical aspheric height profile), the second height profile being defined as:
T(x,y)=Σ{c(i,j)*cos(i*arccos(t))*cos(j*arccos(t))}
where c(i, j) is a coefficient based on i and j, which are each integers (e.g., having a range between 0 and 10), x and y are spatial locations on the freeform-polynomial surface area, and t is a normalized parameter having values between −1.0 and 1.0.
In some embodiments, the optical zone is one of a plurality of optical zones, including a second optical zone, wherein the second optical zone is defined by a second freeform-polynomial surface region characterized and defined by a second polynomial, wherein the second freeform-polynomial surface area has a third height profile T2(x,y) (e.g., an extra height profile associated with cylinder power) superimposed on a first height profile (e.g. a base or typical aspheric height profile), the third height profile being defined as:
T2(x,y)=Σ{c2(i2,j2)*cos(i2*arccos(t2))*cos(j2*arccos(t2))}
where c2(i, j) is a coefficient based on i2 and j2, which are each integers (e.g., ranging between 0 and 10), x and y are spatial locations on the second freeform-polynomial surface area and has values between −1.0 and 1.0, and t2 is a normalized parameter having values between −1.0 and 1.0 (e.g., associated with the intended correction meridian).
In some embodiments, the first freeform-polynomial surface area and the second freeform-polynomial surface area each comprises a monofocal lens, a bifocal lens, a multi-focal lens, or an extended range of vision lens.
In some embodiments, the coefficients c(i, j) or c2 (i2, j2) are a function of local coordinates that puts accumulated high surface amplitude to area of non-functional retinal area.
In some embodiments, the coefficients c(i, j) or c2 (i2, j2) are a function of local coordinates that accounts for irregular corneal shape.
In some embodiments, the angularly-varying phase member is formed of a refractive structure.
In some embodiments, the angularly-varying phase member is formed of a diffractive structure.
In some embodiments, an offset of each meridian of the plurality of meridians of about 10 degrees causes a MTF (modulation transfer function) measure change of less than 10% at 30 cycles per degree (cpd).
In another aspect, an intraocular lens is disclosed, the intraocular lens comprising an angularly-varying phase member configured to direct light, at a first meridian, to a first point of focus, wherein at angular positions nearby to the first meridian, the angularly-varying phase member is configured to direct light to points of focus nearby to the first point of focus such that rotational offsets of the angularly-varying phase member from the first meridian directs light from the nearby points of focus to the first point of focus, thereby establishing an extended band of operational meridian.
In another aspect, an ophthalmic apparatus is disclosed. The ophthalmic apparatus includes a multi-zonal lens body having a plurality of optical zones, wherein the multi-zonal lens body forms an angularly-varying phase member having a center at a first meridian, the angularly-varying phase member, at the center of the first meridian, comprising a refractive structure to direct light to a first point of focus, wherein at angular positions nearby to the first meridian, the refractive structure directs light to points of focus nearby to the first point of focus such that rotational offsets of the multi-zonal lens body from the center of the first meridian directs light from the nearby points of focus to the first point of focus, thereby establishing a band of operational meridian for the apparatus to an intended correction meridian.
In some embodiments, the refractive structure has a height profile at a face of the ophthalmic apparatus that angularly varies along each meridian nearby to the center of the first meridian.
In some embodiments, the height profile of the refractive structure angularly varies in a continuous gradual manner (e.g., in a cosine, sine, or polynomial-based profile).
In some embodiments, the refractive structure angularly varies along each meridian nearby to the center of the first meridian up to a pre-defined angular position of the apparatus.
In some embodiments, pre-defined angular position is at least about 5 degrees from the center of the first meridian.
In some embodiments, the refractive structure varies along each meridian between the first meridian and a third meridian that is about 45 degrees offset to the first meridian and between the first meridian and a fourth meridian that is about −45 degrees offset to the first meridian.
In some embodiments, the multi-zonal lens body comprises at least three optical zones, the at least three optical zones forming an angularly varying efficiency trifocal optics (e.g., wherein the angularly varying efficiency trifocal optics comprises a first angularly varying phase member, e.g., a first refractive angularly varying phase member, at the first meridian; a second angularly varying phase member, e.g., a second refractive angularly varying phase member, at a second meridian; and a third angularly varying phase member, e.g., a third refractive angularly varying phase member, at a third meridian).
In some embodiments, the multi-zonal lens body comprises at least four optical zones, the at least four optical zones forming an angularly varying efficiency quadric optics (e.g., wherein the angularly varying efficiency trifocal optics comprises a first angularly varying phase member, e.g., a first refractive angularly varying phase member, at the first meridian; a second angularly varying phase member, e.g., a second refractive angularly varying phase member, at a second meridian; a third angularly varying phase member, e.g., a third refractive angularly varying phase member, at a third meridian; and a fourth refractive angularly varying phase member, e.g., a fourth refractive angularly varying phase member, at a fourth meridian).
In some embodiments, the multi-zonal lens body forms a second angularly-varying phase member at a second meridian, wherein the second meridian is orthogonal to the first meridian.
In some embodiments, the first angularly-varying phase member and the second angularly-varying phase member, collectively, form an angularly varying efficiency bifocal optics.
In some embodiments, the second angularly-varying phase member has a center at the second meridian, the second angularly-varying phase member varying along each meridian nearby to the center of the second meridian i) between the second meridian and a third meridian that is about 45 degrees offset to the second meridian and ii) between the second meridian and a fourth meridian that is about −45 degrees offset to the second meridian.
In some embodiments, the refractive structure of the first and second angularly-varying phase members each forms a butterfly pattern.
In some embodiments, the refractive structure of the first and second angularly-varying phase members, collectively, forms butterfly pattern that is expressed as
r
(
θ
)
=
2
·
n
·
s
(
θ
)
·
λ
A
(
θ
)
,
where r(θ) is the contour radius for the given meridian added power A(θ), wavelength λ, zone number n, and the scaling value s(θ), all at meridian θ.
In some embodiments, the angularly-varying phase member at the first meridian comprises a monofocal lens.
In some embodiments, the second angularly-varying phase member at the second meridian comprises a second monofocal lens.
In some embodiments, each of i) the third meridian located about 45 degrees from first meridian and ii) the fourth meridian located about −45 degrees from the first meridian, collectively, form a bifocal lens.
In some embodiments, the height profile T1(r, θ) for each meridian θ is defined as:
T1(r,θ)=t1(r)|COS 2(θ)|+t2(r)|SIN 2(θ)|
where t1(r) and t2(r) are the added power for each zone.
In some embodiments, the first angularly-varying phase member establishes the extended band of operational meridian across a range selected from the group consisting of about ±4 degrees, about ±5 degrees, about ±6 degrees, about ±7 degrees, about ±8 degrees, about ±9 degrees, about ±10 degrees, about ±11 degrees, about ±12 degrees, about ±13, degrees, about ±14 degrees, and about ±15 degrees.
In some embodiments, the ophthalmic apparatus includes a plurality of alignment markings, including a first set of alignment markings and a second set of alignment markings, wherein the first set of alignment markings corresponds to the center of the first meridian, and wherein the second set of alignment markings corresponds to the extended band of operational meridian.
In another aspect, a rotationally-tolerant ophthalmic apparatus is disclosed for correcting astigmatism. The ophthalmic apparatus includes a multi-zonal lens body having a plurality of optical zones configured to apply cylinder power at an astigmatism meridian of an eye, the multi-zonal lens body forming an angularly-varying phase member having a peak cylinder power centered at an astigmatism correcting meridian, the angularly-varying phase member, at the astigmatism correcting meridian, having a refractive structure configured to direct light to a first point of focus on the retina, and wherein the refractive structure of the angularly-varying phase member varies, at each optical zone, along meridians nearby to the astigmatism correcting meridian, to direct light to points of focus nearby to the first point of focus such the refractive structure, when rotationally offset from the peak cylinder power, directs light from the nearby points of focus to the first point of focus, thereby establishing a band of operational meridians over the astigmatism meridian.
In another aspect, a rotationally-tolerant ophthalmic apparatus is disclosed for correcting astigmatism. The ophthalmic apparatus includes an astigmatism correcting meridian corresponding to a peak cylinder power associated with a correction of an astigmatism, the ophthalmic apparatus having a plurality of exterior alignment markings, including a first set of alignment markings and a second set of alignment markings, wherein the first set of alignment markings corresponds to the astigmatism correcting meridian, and wherein the second set of alignment markings corresponds to an operational band of the rotationally-tolerant ophthalmic apparatus.
In another aspect, an ophthalmic apparatus is disclosed. The ophthalmic apparatus has regions of one or more base spherical powers and one or more cylinder powers that are added to one or more base spherical power for correcting an astigmatism (e.g., an intended astigmatism), the apparatus comprising one or more optical zones, including an optical zone defined by a polynomial-based surface coincident at a plurality of meridians having distinct cylinder powers, wherein light incident to a given region of a given meridian of each of the plurality of meridians, and respective regions nearby, is directed to a given point of focus such that the regions nearby to the given region direct light to the given point of focus when the given meridian is rotationally offset from the given region, thereby establishing an extended band of operation, and wherein each of the plurality of meridians is uniformly arranged on the optical zone for a same given added diopter of power up to 1.0 D.
In some embodiments, differences among each continuously uniformly distributed contour line, at a given IOL plane, associated with a given meridian of the plurality of meridians is less than about 0.6 D (diopters).
In some embodiments, the same given added diopter is about 0.5 D (diopters).
In some embodiments, the polynomial-based surface establishes the extended band of operation across a range selected from the group consisting of about ±5 degrees, about ±6 degrees, about ±7 degrees, about ±8 degrees, about ±9 degrees, about ±10 degrees, about ±11 degrees, about ±12 degrees, about ±13, degrees, about ±14 degrees, and about ±15 degrees.
In some embodiments, the polynomial-based surface is characterized by a series of weighted cosine-based functions.
In some embodiments, the plurality of meridians include a first meridian, a second meridian, and a third meridian, each having the extended band of operation of at least 10 degrees.
In some embodiments, a first center of the first meridian is angularly spaced about 90 degrees to a second center of the second meridian.
In some embodiments, the optical zone comprises a fourth meridian having an accumulated high surface amplitude such that the first meridian, the second meridian, and the third meridian have the established extended band of operation.
In some embodiments, the fourth meridian is purposely positioned at an angular position that coincides with a diagnosed limited retinal functional area of a patient.
In some embodiments, the polynomial-based surface comprises a refractive surface.
In some embodiments, the polynomial-based surface comprises a diffractive surface.
In some embodiments, an offset of each meridian of the plurality of meridians of about 10 degrees causes a MTF (modulation transfer function) measure change of less than 10% at 30 cycles per degree (cpd).
In some embodiments, the polynomial-bases surface at a first meridian and at a second meridian comprises a bifocal monofocal lens.
In some embodiments, the polynomial-bases surface at a first meridian comprises a monofocal lens.
In some embodiments, the polynomial-bases surface at a first meridian comprises an extended range lens.
In some embodiments, the ophthalmic apparatus includes an accumulated high surface amplitude area disposed at coordinates that coincides with non-functional or limited functional retinal regions of a given patient.
In another aspect, a rotationally-tolerant ophthalmic apparatus is disclosed for correcting astigmatism, the ophthalmic apparatus comprising a multi-zonal lens body having a plurality of optical zones configured to apply cylinder power at an astigmatism meridian of an eye, the multi-zonal lens body forming a angularly-varying phase member having a peak cylinder power centered at an astigmatism correcting meridian, the angularly-varying phase member at the peak cylinder power being configured to direct light to a first point of focus on the retina, and wherein the angularly-varying phase member varies, at each optical zone, along meridians nearby to the astigmatism correcting meridian to direct light to points of focus nearby to the first point of focus such the multi-zonal lens body, when rotational offset from the peak cylinder power, directs light from the nearby points of focus to the first point of focus, thereby establishing a band of operational meridians over the astigmatism meridian, and wherein the angularly-varying phase member has a profile that is uniformly spaced for a same given added diopter of power up to 1.0 D (diopters).
In some embodiments, the band of operation is established across a range selected from the group consisting of about ±5 degrees, about ±6 degrees, about ±7 degrees, about ±8 degrees, about ±9 degrees, about ±10 degrees, about ±11 degrees, about ±12 degrees, about ±13, degrees, about ±14 degrees, and about ±15 degrees.
In some embodiments, the polynomial-based surface is characterized by a series of weighted cosine-based function.
In some embodiments, the angularly-varying phase member has a band of operation of at least 10 degrees.
In some embodiments, the multi-zonal lens body forms a second angularly-varying phase member having a second peak cylinder power centered at a second correcting meridian, the second angularly-varying phase member at the second peak cylinder power being configured to direct light to a second point of focus on the retina, and wherein the second angularly-varying phase member varies, at each optical zone, along meridians nearby to the second correcting meridian to direct light to points of focus nearby to the second point of focus such the multi-zonal lens body, when rotational offset from the second peak cylinder power, directs light from the nearby points of focus to the second point of focus, and wherein the second angularly-varying phase member has the profile that is uniformly spaced for a same given added diopter of power up to 1.0 D (diopters).
In some embodiments, the multi-zonal lens body forms a second angularly-varying phase member having a second peak cylinder power centered at a second correcting meridian, the second angularly-varying phase member at the second peak cylinder power being configured to direct light to a second point of focus on the retina, and wherein the second angularly-varying phase member varies, at each optical zone, along meridians nearby to the second correcting meridian to direct light to points of focus nearby to the second point of focus such the multi-zonal lens body, when rotational offset from the second peak cylinder power, directs light from the nearby points of focus to the second point of focus, and wherein the second angularly-varying phase member has a second profile that is uniformly spaced for a same given added diopter of power up to 1.0 D.
In another aspect, an ophthalmic apparatus is disclosed, the apparatus having regions of one or more base spherical powers and one or more cylinder powers that are added to the one or more base spherical power for correcting an astigmatism (e.g., an intended astigmatism), the apparatus comprising one or more optical zones, including a first optical zone defined by a freeform-polynomial surface area (e.g., as area having one or more refractive surfaces) coincident with one or more distinct cylinder powers, wherein light incident to a first region of the freeform-polynomial surface area, and regions nearby to the first region, is directed to a first point of focus such that the regions nearby to the first region direct light to the first point of focus when the first freeform-polynomial surface area is rotationally offset from the first region, thereby establishing a band of operational meridian for the apparatus to an intended correction meridian, and wherein the freeform-polynomial surface area is defined as a mathematical expression comprising a combination of one or more polynomial expressions (e.g., Chebyshev-based polynomial expression, Zernike-based polynomial expression, etc.) each having a distinct complex orders.
In some embodiments, at least one of the one or more polynomial expression is selected from the group consisting of a Chebyshev polynomial and a Zernike polynomial.
In some embodiments, the freeform-polynomial surface area establishes the band of operational meridian across a range selected from the group consisting of about ±4 degrees, about ±5 degrees, about ±6 degrees, about ±7 degrees, about ±8 degrees, about ±9 degrees, about ±10 degrees, about ±11 degrees, about ±12 degrees, about ±13, degrees, about ±14 degrees, and about ±15 degrees.
In some embodiments, the freeform-polynomial surface area has a height profile T(x,y) (e.g., an extra height profile having an associated cylinder power) on a first base height profile (e.g., a base or typical aspheric height profile), the height profile being defined as:
T(x,y)=Σ{c(i,j)*cos(i*arccos(t))*cos(j*arccos(t))}
where c(i, j) is a coefficient based on i and j, which are each integers (e.g., having a range between 0 and 10), x and y are spatial locations on the freeform-polynomial surface area, and t is a normalized parameter having values between −1.0 and 1.0.
In some embodiments, the freeform-polynomial surface area has the second height profile T(x,y) in which i has an order of 0 to at least 6 and j has an order of 0 to at least 6.
In some embodiments, the freeform-polynomial surface area spans the entire optical face of the apparatus), wherein the ophthalmic apparatus comprises an optical face (e.g., the portion of the face surface of the ophthalmic apparatus that include corrective optical structures) that includes the one or more optical zones, the optical face having a boundary defined by a first axis of the face and a second axis of the face (e.g., wherein the first axis is orthogonal to the second axis), and wherein each of the x-spatial locations at value −1.0 and at value 1.0 coincides with, or near, the boundary, and each of the y-spatial locations at value −1.0 and at value 1.0 coincides with, or near, the boundary.
In some embodiments, the ophthalmic apparatus comprises an optical face (e.g., the portion of the face surface of the ophthalmic apparatus that include corrective optical structures) that includes the one or more optical zones, the optical face having a boundary defined by a first axis of the face and a second axis of the face (e.g., wherein the first axis is orthogonal to the second axis), and wherein each of the x-spatial locations at value −1.0 and at value 1.0 is located at a first radial position along the first axis between a center location of the ophthalmic apparatus and the boundary, and wherein each of the y-spatial locations at value −1.0 and at value 1.0 is located at the first radial position along the second axis between the center location of the ophthalmic apparatus and the boundary.
In some embodiments, the ophthalmic apparatus comprises an optical face (e.g., the portion of the face surface of the ophthalmic apparatus that include corrective optical structures) that includes the one or more optical zones, the optical face having a boundary defined by a first axis of the face and a second axis of the face (e.g., wherein the first axis is orthogonal to the second axis), and wherein each of the x-spatial locations at value −1.0 and at value 1.0 is located at a first radial position along the first axis between a center location of the ophthalmic apparatus and the boundary, and wherein each of the y-spatial locations at value −1.0 and at value 1.0 is located at a second radial position along the second axis between the center location of the ophthalmic apparatus and the boundary, wherein the first radial position and the second radial position are different.
In some embodiments, the freeform-polynomial surface area has for each continuously distributed contour line at the IOL plane a difference of less than about 0.6 Diopters.
In some embodiments, the one or more optical zones includes a second optical zone defined by a second freeform-polynomial surface region, wherein the second freeform-polynomial surface area is characterized and defined by a second polynomial.
In some embodiments, the second freeform polynomial surface area has a second height profile that varies according to a freeform polynomial selected from the group consisting of a Chebyshev polynomial and a Zernike polynomial.
In some embodiments, the one or more optical zones includes a second optical zone defined by a second freeform-polynomial surface region, wherein the second freeform-polynomial surface area is characterized and defined by a second combination of one or more polynomial expressions (e.g., Chebyshev-based polynomial expression, Zernike-based polynomial expression, etc.) each having a distinct complex orders.
In some embodiments, at least one of the one or more polynomial expression is selected from the group consisting of a Chebyshev polynomial and a Zernike polynomial.
In some embodiments, light incident to a second region of the second freeform-polynomial surface area, and regions nearby to the second region, is directed to a second point of focus such that the regions nearby to the second region direct light to the second point of focus when the second freeform-polynomial surface area is rotationally offset from the second region.
In some embodiments, light incident to a second region of the second freeform-polynomial surface area, and regions nearby to the second region, is directed to the first point of focus such that the regions nearby to the second region direct light to the first point of focus when the second freeform-polynomial surface area is rotationally offset from the second region (e.g., over the band of operational meridian).
In some embodiments, the second freeform-polynomial surface area has a third height profile T2(x,y) (e.g., an extra height profile associated with cylinder power) superimposed on a first height profile (e.g. a base or typical aspheric height profile), the third height profile being defined as:
T2(x,y)=Σ{c2(i2,j2)*cos(i2*arccos(t2))*cos(j2*arccos(t2))}
where c2(i, j) is a coefficient based on i2 and j2, which are each integers (e.g., ranging between 0 and 10), x and y are spatial locations on the second freeform-polynomial surface area and has values between −1.0 and 1.0, and t2 is a normalized parameter having values between −1.0 and 1.0 (e.g., associated with the intended correction meridian).
In some embodiments, the first freeform-polynomial surface area comprise a monofocal lens, a bifocal lens, or a multi-focal lens.
In some embodiments, the second freeform-polynomial surface area comprise a monofocal lens, a bifocal lens, or a multi-focal lens.
In some embodiments, the first freeform-polynomial surface area comprise an extended range of vision lens.
In some embodiments, the second freeform-polynomial surface area comprise an extended range of vision lens.
In some embodiments, the first freeform-polynomial surface area comprises refractive surfaces.
In some embodiments, the first freeform-polynomial surface area comprises diffractive surfaces.
In some embodiments, the coefficients c(i, j) are a function of local coordinates that puts accumulated high surface amplitude to area of non-functional retinal area.
In some embodiments, the coefficients c(i, j) are a function of local coordinates that accounts for irregular corneal shape.
In another aspect, a method of designing an ophthalmic apparatus (e.g., the design of FIG. 4) having regions of one or more base spherical powers and one or more cylinder powers that are added to the one or more base spherical power for correcting an astigmatism (e.g., an intended astigmatism), the method comprising: generating, via a processor, one or more optical zones, including a first optical zone defined by a freeform-polynomial surface area (e.g., as area having one or more refractive surfaces) coincident with one or more distinct cylinder powers, wherein light incident to a first region of the freeform-polynomial surface area, and regions nearby to the first region, is directed to a first point of focus such that the regions nearby to the first region direct light to the first point of focus when the first freeform-polynomial surface area is rotationally offset from the first region, thereby establishing a band of operational meridian for the apparatus to an intended correction meridian, and wherein the freeform-polynomial surface area is defined as a mathematical expression comprising a combination of one or more polynomial expressions (e.g., Chebyshev-based polynomial expression, Zernike-based polynomial expression, etc.) each having a distinct complex orders.
It is contemplated that the angularly-varying phase member may be purely refractive or a hybrid of diffractive and refractive. It is also contemplated that angularly-varying phase members may comprise of different materials such as a stacking lens, where each layer is comprised of a different material. It is further contemplated that the angularly-varying phase members may be comprised of a material or materials that have a variation in refractive index, a gradient index, or a programmed index, for example liquid crystal which creates the refractive change.
In some embodiments, the angularly-varying phase member establishes the band of operational meridian across a range selected from the group consisting of about ±4 degrees, about ±5 degrees, about ±6 degrees, about ±7 degrees, about ±8 degrees, about ±9 degrees, about ±10 degrees, about ±11 degrees, about ±12 degrees, about ±13, degrees, about ±14 degrees, and about ±15 degrees.
In another aspect, a rotationally-tolerant ophthalmic apparatus (e.g., toric intraocular lens) having an established band of operation meridians (e.g., at least about ±4 degrees or more) for placement over an intended astigmatism meridian is disclosed. The ophthalmic apparatus includes a multi-zonal lens body having a plurality of optical zones, where the multi-zonal lens body forms the angularly-varying phase member. The angularly-varying phase member has a center at an astigmatism correction meridian that directs light to a first point of focus (e.g., on the retina). At angular positions nearby to the astigmatism correction meridian, the portion of the angularly-varying phase member at such angular positions directs light to points of focus of varying depths and nearby to the first point of focus such that rotational offsets of the multi-zonal lens body from the center of the astigmatism correction meridian directs light from the nearby points of focus to the first point of focus.
In another aspect, a rotationally-tolerant ophthalmic apparatus for correcting astigmatism is disclosed. The ophthalmic apparatus includes an astigmatism correcting meridian that corresponds to a peak cylinder power associated with a correction of an astigmatism. The rotationally-tolerant ophthalmic apparatus may include a plurality of exterior alignment markings, including a first set of alignment markings and a second set of alignment markings. The first set of alignment markings corresponds to the astigmatism correcting meridian, and the second set of alignment markings corresponds to an operation band of the rotationally-tolerant ophthalmic apparatus.
BRIEF DESCRIPTION OF THE DRAWINGS
Embodiments of the present invention may be better understood from the following detailed description when read in conjunction with the accompanying drawings. Such embodiments, which are for illustrative purposes only, depict novel and non-obvious aspects of the invention. The drawings include the following figures:
FIGS. 1A and 1B are diagrams of an exemplary ophthalmic apparatus (e.g., an intraocular toric lens) that includes angularly-varying phase members (reflective, diffractive, or both) that each provides an extended rotational tolerance of the apparatus in accordance with an illustrative embodiment.
FIGS. 2A, 2B, 2C, 2D, 2E, and 2F, each illustrates a plurality of exemplary height profiles of the anterior or posterior face of the ophthalmic apparatus of FIGS. 1A-1B in accordance with an illustrative embodiment.
FIG. 3 is a schematic drawing of a top view of a human eye, in which the natural lens of the eye has been removed and replaced with an ophthalmic apparatus that includes angularly-varying phase members in accordance with an illustrative embodiment.
FIGS. 4A, 4B, 4C, and 4D are schematic diagrams of exemplary ophthalmic apparatuses that include either refractive or diffractive angularly-varying phase members, in accordance with an illustrative embodiment.
FIGS. 5A and 5B are plots illustrating performance of a conventional tonic lens designed to apply maximum cylinder power at a corrective meridian when subjected to rotational misalignment.
FIGS. 6A and 6B show plots of off-axis performances of an exemplary ophthalmic apparatus (diffractive or refractive) that includes angularly-varying phase members in accordance with an illustrative embodiment.
FIGS. 7A and 7B are diagrams of an exemplary ophthalmic apparatus that includes angularly-varying phase members in accordance with another illustrative embodiment.
FIGS. 8 and 9 are diagrams illustrating height profiles of exemplary ophthalmic apparatuses of FIGS. 1A-1B and 7A-7B in accordance with the illustrative embodiments.
FIG. 10 is a diagram of an exemplary multi-focal lens ophthalmic apparatus that includes angularly-varying phase members in accordance with another illustrative embodiment.
FIG. 11 is a diagram illustrating the multi-focal lens ophthalmic apparatus of FIG. 10 configured as a bifocal lens in accordance with another illustrative embodiment.
FIG. 12 is a diagram illustrating the multi-focal lens ophthalmic apparatus of FIG. 10 configured as a tri-focal lens in accordance with another illustrative embodiment.
FIG. 13 is a diagram of an exemplary ophthalmic apparatus that includes angularly-varying phase members (refractive, diffractive, or both) in accordance with another illustrative embodiment.
FIG. 14 is a table of the ophthalmic apparatus of FIG. 13 configured as a tri-focal lens in accordance with another illustrative embodiment.
FIGS. 15A and 15B are diagrams of an exemplary ophthalmic apparatus that includes angularly-varying phase members with asymmetric height profiles in accordance with another illustrative embodiment.
FIGS. 16A, 16B, and 16C, each illustrates a plurality of exemplary height profiles of the ophthalmic apparatus of FIGS. 15A-15B in accordance with an illustrative embodiment.
FIGS. 17A and 17B are diagrams of an exemplary ophthalmic apparatus that includes angularly-varying phase members and a symmetric height profile in accordance with another illustrative embodiment.
FIGS. 18A, 18B, and 18C, each illustrates a plurality of exemplary height profiles of the anterior or posterior face of the ophthalmic apparatus of FIGS. 17A-17B in accordance with an illustrative embodiment.
FIGS. 19A and 19B are diagrams of an exemplary ophthalmic apparatus that includes refractive angularly-varying phase members in accordance with another illustrative embodiment.
FIGS. 20A, 20B, 20C, 20D, and 20E illustrate a plurality of exemplary height profiles of the anterior or posterior face of the ophthalmic apparatus of FIGS. 19A-19B, in accordance with an illustrative embodiment.
FIGS. 21A, 21B, and 21C are diagrams illustrating an exemplary ophthalmic apparatus that includes refractive angularly-varying phase members, in accordance with another illustrative embodiment.
FIGS. 22A and 22B are diagrams illustrating a top and bottom view of an ophthalmic apparatus of FIGS. 15A-15B with extended tolerance band markers in accordance with an illustrative embodiment.
FIG. 23 is diagram of a method to generate, via a processor, the surface with the angularly-varying phase members, in accordance with an illustrative embodiment.
FIG. 24 is a diagram of an example freeform-polynomial surface area that provides extended rotational tolerance, in accordance with an illustrative embodiment.
FIG. 25 illustrates an example operation of the freeform-polynomial surface area of FIG. 24 when subjected to misalignment, in accordance with an illustrative embodiment.
FIG. 26 shows a combined cylinder map generated from the combination of the IOL cylindrical power (provided, in part, via the freeform-polynomial surface) combined with the corneal cylindrical power through meridians.
FIGS. 27A and 27B each shows calculated MTF values as spatial frequencies of an exemplified IOL in a physiological eye model with astigmatic cornea in different cylindrical axis misalignment (CAM) situations between the cornea and the IOL for an iris pupil.
FIG. 28A shows a diagram of a freeform-polynomial surface area (e.g., the second or third height profile) of a second optical zone that symmetrically spans part of the optical face of the apparatus, in accordance with an illustrative embodiment.
FIG. 28B shows a diagram of a freeform-polynomial surface area (e.g., the second or third height profile) of a second optical zone that symmetrically spans part of the optical face of the apparatus, in accordance with an illustrative embodiment.
FIG. 29 is a diagram of cylindrical map of a polynomial surface that is uniformly arranged over a plurality of meridians that provides extended rotational tolerance, in accordance with an illustrative embodiment.
FIG. 30 is a diagram of the ETA polynomial surface of FIG. 29 shown with the plurality of uniformly arranged meridians, in accordance with an illustrative embodiment.
FIG. 31 is a profile of the polynomial surface of FIG. 29 with the plurality of uniformly arranged meridians, in accordance with an illustrative embodiment.
FIG. 32 illustrates an example operation of the polynomial surface of FIG. 29 when subjected to misalignment, in accordance with an illustrative embodiment.
FIG. 33 shows a combined cylinder map generated from the combination of the IOL cylindrical power (provided, in part, via the polynomial surface) combined with the corneal cylindrical power through meridians.
FIG. 34 shows the combined cylinder map of FIG. 33 with the meridians shown in FIG. 30 superimposed thereon.
FIGS. 35A and 35B each shows calculated MTF values as spatial frequencies of an exemplified IOL 100 in a physiological eye model with astigmatic cornea in different cylindrical axis misalignment (CAM) situations between the cornea and the IOL for an iris pupil.
FIG. 36 is a surface SAG map of the polynomial surface 2902 of FIG. 29, in accordance with an illustrative embodiment.
FIG. 37 is a diagram of an example computing device configured to generate the surface with the angularly-varying phase members.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
Each and every feature described herein, and each and every combination of two or more of such features, is included within the scope of the present invention provided that the features included in such a combination are not mutually inconsistent.
Embodiments of the present invention are generally directed to toric lenses or surface shapes, and/or related methods and systems for fabrication and use thereof. Toric lenses according to embodiments of the present disclosure find particular use in or on the eyes of human or animal subjects. Embodiments of the present disclosure are illustrated below with particular reference to intraocular lenses; however, other types of lenses fall within the scope of the present disclosure. Embodiments of the present disclosure provide improved ophthalmic lens (including, for example, contact lenses, and intraocular lenses, corneal lenses and the like) and include monofocal refractive lenses, monofocal diffractive lenses, bifocal refractive lenses, bifocal diffractive lenses, and multifocal refractive lenses, multifocal diffractive lenses.
As used herein, the term “refractive optical power” or “refractive power” means optical power produced by the refraction of light as it interacts with a surface, lens, or optic. As used herein, the term “diffractive optical power” or “diffractive power” means optical power resulting from the diffraction of light as it interacts with a surface, lens, or optic.
As used herein, the term “optical power” means the ability of a lens or optics, or portion thereof, to converge or diverge light to provide a focus (real or virtual), and is commonly specified in units of reciprocal meters (m−1) or Diopters (D). When used in reference to an intraocular lens, the term “optical power” means the optical power of the intraocular lens when disposed within a media having a refractive index of 1.336 (generally considered to be the refractive index of the aqueous and vitreous humors of the human eye), unless otherwise specified. Except where noted otherwise, the optical power of a lens or optic is from a reference plane associated with the lens or optic (e.g., a principal plane of an optic). As used herein, a cylinder power refers to the power required to correct for astigmatism resulting from imperfections of the cornea and/or surgically induced astigmatism.
As used herein, the terms “about” or “approximately”, when used in reference to a Diopter value of an optical power, mean within plus or minus 0.25 Diopter of the referenced optical power(s). As used herein, the terms “about” or “approximately”, when used in reference to a percentage (%), mean within plus or minus one percent (±1%). As used herein, the terms “about” or “approximately”, when used in reference to a linear dimension (e.g., length, width, thickness, distance, etc.) mean within plus or minus one percent (1%) of the value of the referenced linear dimension.
FIGS. 1A and 1B are diagrams of an exemplary ophthalmic apparatus 100 (e.g., an intraocular toric lens) that includes angularly-varying phase members 102 (refractive, diffractive, or both) configured to provide extended rotational tolerance in accordance with an illustrative embodiment.
The angularly-varying phase members have a center structure that applies cylinder power at a corrective meridian (e.g., the high power meridian). In FIGS. 1A and 1B, the corrective meridian is shown at Θ=0° and Θ=180° with the center structure being disposed at such Θ positions. Off-center structures of the angularly-varying phase members extend from the center structure in a gradually varying manner to apply cylinder power to a band of meridians surrounding the corrective meridian enabling the ophthalmic apparatus to operate off-axis (or off-meridian) to the corrective meridian (e.g., the astigmatism meridian). As shown in FIG. 1A, the off-center structures extends, at least, from Θ=0° to Θ=10° and Θ=−10° to facilitate off-axis operation (from Θ=0°) up to ±10°. The off-center structures may extend from Θ=0° to Θ=90° and Θ=−90°. These meridians may be referred to as a dynamic meridian.
Although the operational boundaries of the angularly varying phase members are shown to be at about ±10°, it is contemplated that other angular values may be used, as are discussed herein. In addition, in some embodiments, it is also contemplated that operational boundaries may be symmetrical or asymmetrical. For example, in certain embodiments, the operational boundaries may be skewed to one rotation, e.g., between +9° and −11° or, e.g., between +11° and −9°.
The angularly-varying phase members, in some embodiments, include an optimized combination of angularly and zonally diffractive (or refractive) phase structure located at each meridian to vary the extended depth of focus to a plurality of nearby focus points. Light directed to such nearby focus points are thus directed to the desired focus point when the ophthalmic apparatus is subjected to a rotational offset from a primary intended axis of alignment, thereby extending the rotational tolerance of the apparatus to an extended tolerance band. This may also be referred to as “extended tolerance astigmatism band” or “extended misalignment band.” Remarkably, this extended tolerance astigmatism band delivers cylinder power to correct for the astigmatism for a range of meridians (e.g., up to ±10° or more as shown in FIGS. 1A and 1B), thereby eliminating any need for additional corrective measures (e.g., supplemental corrective devices or another surgical intervention) when the implanted ophthalmic apparatus is not perfectly aligned to the desired astigmatism meridian in the eye.
Put another way, the angularly-varying phase members facilitate an extended band of the corrective meridian that has minimal, and/or clinically acceptable, degradation of the visual acuity and modulation transfer function when the ophthalmic apparatus is subjected to rotational misalignment between the astigmatic axis and a center axis of the corrective meridian.
In some embodiments, an exemplified toric IOL includes dynamic meridian or angularly varying efficiency quadric optics. In another embodiment, an exemplified toric IOL includes dynamic meridian or angularly varying efficiency trifocal optics. In another embodiment, an exemplified toric IOL includes double dynamic meridian or angularly varying efficiency bifocal optics. In another embodiment, the bifocal or trifocal feature may be disposed on one optical surface or on both optical surfaces of a single optical lens or on any surfaces of a multiple optical elements working together as a system.
Referring still to FIGS. 1A and 1B, an embodiment of the angularly-varying phase members 102 is shown. In this embodiment, the angularly-varying phase members 102 are formed in multiple-zones (shown as zones 120a, 120b, 120c), each forming a spatially-varying “butterfly” shaped structure centered around the optical axis 106. The multiple-zone structure (120a, 120b, and 120c), and angularly-varying phase members 102 therein, form a first “high power meridian” (e.g., having a constant power equal to the base spherical power plus a cylinder power of the lens) at a first meridian (e.g., axis 110 shown as Θ=0° and Θ=180°) that corresponds to an axis of the eye to apply a correction. The first corrective meridian 110 focuses light that passes therethrough to a first foci (i.e., point of focus) and is intended to align with the astigmatic axis of the eye. At nearby meridians (e.g., −10°, −9°, −8°, −7°, −6°, −5°, −4°, −3°, −2°, −1°, 1°, 2°, 3°, 4°, 5°, 6°, 7°, 8°, 9°, and 10°), the angularly-varying phase members 102 focus light that passes therethrough to a plurality of foci near the first foci. The angularly-varying phase members 102 vary from between the first meridian (Θ=0°) and another meridian located about 10 degrees from the first meridian (e.g., axis 114 shown as Θ=10°).
FIGS. 1A and 1B illustrate the exemplary ophthalmic apparatus 100 having a diffractive surface 120. A diffractive surface comprises multiple echelette elements. In some embodiments, an intraocular lens, which has a diffractive grating covering its entire surface, has between 15 and 32, or more echelette elements. In some embodiments, the diffractive grating includes more than 32 echelette elements. As shown in FIGS. 1A and 1B, multiple echelette elements cover each region, or if there is one echelette element, or the echelette spans only a portion of the region, then a refractive area will cover the rest of the region. Though shown here as a diffractive surface, the angularly varying phase members are later illustrated as a refractive surface, as later discussed herein.
As shown in FIGS. 1A and 1B, both the heights (i.e., thicknesses) of the lens and the spatial sizes, at each zone, vary among the different axes to form the angularly-varying phase member 102. To illustrate this structure, both a first height profile 116 of the lens along the first corrective meridian (e.g., at Θ=0°) and a second height profile 118 of the lens along a lower power meridian (i.e., at axis 114 shown as Θ=10°) are presented at plots 108a and 108b, respectively, for each of FIGS. 1A and 1B. The height profile of the lens varies at each axis as the first height profile 116 gradually transitions (e.g., as shown by the curved profile 122) into the second height profile 118. The first and second height profiles 116 and 118 are illustrated relative to one another in a simplified format. It should be appreciated that there may be multiple echelette elements (i.e., diffractive structures) in each of the multiple zone structures, surrounded by a refractive region. Alternatively, rather than relying on diffraction, one or more of the multiple zone structures may have only refraction surfaces to vary power.
It should also be appreciated that the height profiles herein are illustrated in a simplified form (e.g., as a straight line). The height profiles for each zone may form other surfaces—such as refractive, diffractive—or have other shapes—such convex, concave, or combinations thereof. The profiles may be added to, or incorporated into, a base lens as, for example, shown in FIGS. 4A, 4B, 4C, and 4D. FIGS. 4A, 4B, 4C, and 4D are schematic diagrams of exemplary ophthalmic apparatuses that include either refractive or diffractive angularly-varying phase members, in accordance with an illustrative embodiment.
Referring still to FIGS. 1A and 1B, the multiple-zone structure (e.g., 104a, 104b, and 104c), and angularly-varying phase members 126 therein, form a second “high power meridian” 112 (i.e., axis 112 shown as Θ=90°) which is orthogonal to the first corrective meridian 110. The second corrective meridian 112 includes a second angularly varying phase structure 126. In some embodiments, the second angularly varying phase structure focuses light to a second set of foci (e.g., as part of a multi-focal lens configuration).
FIGS. 2A, 2B, 2C, 2D, 2E, and 2F, each illustrates a plurality of height profiles of the angularly-varying phase member 102 of FIGS. 1A and 1B between the first high power meridian (at Θ=0°) and the operational edge of the angularly varying phase members in accordance with an illustrative embodiment. In FIG. 2B, representative height profiles (of an echelette element) at Θ=0° (202); Θ=2° (204); Θ=4° (206); Θ=6° (208); Θ=8° (210); and Θ=10° (212) (also shown in FIG. 2A) are provided as cross-sections of the echelette elements at the different meridians shown in FIG. 2A. As shown, the height profiles at axes nearby to the first high power meridian (e.g., between ±10°) have a similar shape, as the first high power meridian. The height profile varies in a continuous gradual manner (e.g., having a sine and cosine relationship) along the radial direction (e.g., at different radial values) and along the angular direction (e.g., at different angular positions). The varying of the angular position and of the radial position, e.g., between Θ=0° and Θ=10° and between Θ=0° and Θ=−10° forms the angularly varying phase member. This can also be observed in FIGS. 2B and 2C. In FIGS. 2B and 2C, the edge of an echelette element of the height profile of the angularly-varying phase member at Θ=2° (204) is shown to vary more abruptly in relation to the center meridian at Θ=0° (202). The abrupt transition in the edge position is shown to transition more slowly at Θ=4° (206), and even more slowly at Θ=6° (208); then Θ=8° (210); and then Θ=10° (212). In contrast, the height profile transitions more slowly near the center meridian at Θ=0° and then more sharply at the edge. This transition may be described as a cosine-based or sine-based function, a polynomial function, or a function derived from a combination thereof.
FIG. 2C illustrates a height profiles (near the optical axis and between the operational boundaries of the angularly varying phase member 102) at Θ=0° (202); Θ=2° and −2° (204); Θ=4° and −4° (206); Θ=6° and −6° (208); Θ=8° and −8° (210); and Θ=10° and −10° (212) superimposed next to one another. This variation of the height profile along the radial axis provides a lens region that focuses light at the desired foci and other foci nearby. To this end, radial offset (i.e., misalignment) of the ophthalmic apparatus from the center axis of a desired corrective meridian results in its nearby regions focusing the light to the desired foci. This effect is further illustrated in FIG. 3.
In FIGS. 2D, 2E, and 2F, example height profiles of the lens surface between Θ=0° and Θ=45° are shown. As shown in FIGS. 2E and 2F, the height profiles of the angularly varying phase member vary as a cosine-based or sine-based function. In some embodiments, the height profiles of the lens surface between Θ=45° and Θ=90° are mirrored at Θ=45° to the lens surface between Θ=0° and Θ=45°.
FIG. 3 is a schematic drawing of a top view of a human eye 302, in which the natural lens of the eye 302 has been removed and replaced with an intraocular lens 100 (shown in simplified form in the upper portion of FIG. 3 and in greater detail in the lower portion of FIG. 3). Light enters from the left of FIG. 3, and passes through the cornea 304, the anterior chamber 306, the iris 308, and enters the capsular bag 310. Prior to surgery, the natural lens occupies essentially the entire interior of the capsular bag 310. After surgery, the capsular bag 310 houses the intraocular lens 100, in addition to a fluid that occupies the remaining volume and equalizes the pressure in the eye.
After passing through the intraocular lens, light exits the posterior wall 312 of the capsular bag 310, passes through the posterior chamber 328, and strikes the retina 330, which detects the light and converts it to a signal transmitted through the optic nerve 332 to the brain. The intraocular lens 100 comprises an optic 324 and may include one or more haptics 326 that are attached to the optic 324 and may serve to center the optic 324 in the eye and/or couple the optic 324 to the capsular bag 310 and/or zonular fibers 320 of the eye.
The optic 324 has an anterior surface 334 and a posterior surface 336, each having a particular shape that contributes to the refractive or diffractive properties of the lens. Either or both of these lens surfaces may optionally have an element made integral with or attached to the surfaces. FIGS. 4A, 4B, 4C, and 4D are schematic diagrams of exemplary ophthalmic apparatuses that include either refractive or diffractive angularly-varying phase members, in accordance with an illustrative embodiment. Specifically, FIGS. 4A and 4B show examples of diffractive lenses, and FIGS. 4C and 4D show examples of refractive lenses. The diffractive lenses or refractive lenses includes the angularly varying phase members as described herein. The refractive and/or diffractive elements on the anterior and/or posterior surfaces, in some embodiments, have anamorphic or toric features that can generate astigmatism to offset the astigmatism from a particular cornea in an eye.
Referring still to FIG. 3, the intraocular lens 100 includes angularly-varying phase members (reflective, diffractive, or both) that focus at a plurality of focus points that are offset radially to one another so as to provide an extended tolerance to misalignments of the lens 100 when implanted into the eye 302. That is, when the center axis of a corrective meridian is exactly matched to the desired astigmatic axis, only a first portion of the cylinder axis is focused at the desired point of focus (338) (e.g., at the retina) while second portions of the cylinder axis focuses at other points (340) nearby that are radially offset to the desired point of focus (338). To this end, when the primary axis of the astigmatism of the intraocular lens is rotationally offset (shown as arrow 342) with the astigmatism of the eye, the second portion of the cylinder axis focuses the light to the desired point of focus.
Artificial lenses (e.g., contact lenses or artificial intraocular lenses) can correct for certain visual impairments such as an inability of the natural lens to focus at near, intermediate or far distances; and/or astigmatism. Intraocular toric lenses have the potential for correcting astigmatism while also correcting for other vision impairments such as cataract, presbyopia, etc. However, in some patients, implanted intraocular toric lenses may not adequately correct astigmatism due to rotational misalignment of the corrective meridian of the lenses with the astigmatic meridian. In some patients following the surgical implant of the toric lenses, the corrective meridian of the implanted toric lenses can be rotationally misaligned to the astigmatic meridian, in some instances, by as much as 10 degrees. However, toric lenses that are designed to provide maximum correction (e.g., 1 D to 9 D) at the astigmatic meridian are subject to significant reduction in effectiveness of the correction due to any misalignment from the corrective meridian. In certain designs, it is observed that if the cylindrical power axis were mismatched by 1 degree, there would be about 3 percent reduction of the effectiveness of the correction. The degradation increases with the degree of misalignment. If there were a 10-degree misalignment, there would be about 35% reduction of the effectiveness of the correction. This effect is illustrated in FIG. 4 discussed below.
FIGS. 5A and 5B include plots that illustrated the above-discussed degraded performance of conventional toric lens when subjected to rotational misalignments. This conventional toric lens is configured to provide 6.00 Diopters cylinder powers at the IOL plane, 4.11 Diopters cylinder power at the corneal plane, and a corneal astigmatism correction range (i.e., preoperative corneal astigmatism to predicted effects) between 4.00 and 4.75 Diopters.
Referring to FIG. 5A, a plot of the undesired meridian power (also referred to as a residual meridian power (“OC”)) (shown along the y-axis) added due to the rotational misalignments (shown along the x-axis) of the toric IOL is shown, including the residual powers for i) a negative 10-degree misalignment (shown as line 502), ii) a 0-degree misalignment (shown as line 504), and iii) a positive 10-degree misalignment (shown as line 506). As shown, the undesired added meridian power varies between a maximum of ±0.75 Diopters at around the 45-degree meridian angle (shown as 508) and at about the 135-degree meridian angle (shown as 510). Notably, this undesired added meridian power is outside the tolerance of a healthy human eye, which can tolerant undesired effects up to about 0.4 Diopters (e.g., at the cornea plane) for normal visual acuity (i.e., “20/20 vision”). Because the undesired effects exceeds the astigmatism tolerance of the human eye, corrective prescription glasses, or further surgical operation to correct the implant misalignment, may be necessary to mitigate the effects of the misalignment of such toric IOLs.
This undesired meridian power may be expressed as Equation 1 below.
O
C
=
2
sin
α
*
C
2
0.7
cos
(
2
(
θ
+
9
0
+
α
2
)
)
(
Equation
1
)
As shown in Equation 1, θ is the correction meridian (also referred to as the cylindrical power axis) (in degrees); C is the astigmatic power (at the IOL plane) to be corrected at meridian θ (in Diopters); and a is the magnitude of rotational misalignment of the cylindrical power axis to the astigmatic axis (in degrees).
FIG. 5B shows a plot illustrating the tolerance of a toric IOL to misalignment (shown in the y-axis) and a corresponding cylindrical power that may be applied (shown in the x-axis) for each misalignment to not exceed the astigmatism tolerance of the human eye (i.e., degrade the overall visual acuity). The tolerance to misalignment may be calculated as
α
≤
sin
-
1
0.4
2
C
0.7
where α is the magnitude of rotational misalignment (in degrees). The calculation may be reduced to
α
≤
sin
-
1
0.29
C
.
As shown, for a misalignment of 5 degrees, which is routinely observed in IOL implantations, the correction effectiveness of such IOL implants can only be maintained for a toric IOL with 3.75 Diopters or less. That is, a toric IOL having cylinder power above 3.75 Diopters would exhibit degraded visual acuity due to the residual power exceeding the astigmatism tolerance of a human eye. This effect is worsen with further degrees of misalignment. For example, at about 10 degrees, the effectiveness of a toric IOL is greatly reduced where only 1.5 Diopters cylinder power or less can be applied so as to not detrimentally effect the visual acuity. Given that cylinder power of convention toric IOLs may range between 1.00 Diopters and 9.00 Diopters, these toric IOLs are reduced in effectiveness post-operation due to the misalignments of cylinder axis.
Each of FIGS. 6A and 6B shows plots illustrating modular transfer functions (MTFs) in white light for two toric IOLs (shown as 602a and 602b) each configured with angularly-varying phased members when subjected to off-axis rotations. FIG. 6A illustrates the performance for a refractive toric IOL, and FIG. 6B illustrates performance for a diffractive toric IOL.
Remarkably, the cylinder power of the lens configured with angularly varying phase members provides an extended tolerance of misalignment up to 10 degrees, and more, of off-axis rotation. As shown in FIGS. 6A and 6B, the modulation transfer function (MTF) is maintained across the extended range of alignment for a lens configured with the angularly varying phase members. In contrast, at certain degrees of misalignment, the MTF of a toric IOL (shown as lines 604a and 604b) without the angularly varying phase member is near zero. For example, as shown in FIG. 6A, the MTF at about 3.5 degrees misalignment for a conventional toric lens is near zero. MTF is a modulation of the amplitude and phase functions of an image formed by the white light on a specified plane, e.g., the retina of the human eye, and characterizes the sensitivity of the lens.
Referring still to FIGS. 6A and 6B, an ophthalmic apparatus that includes angularly varying phase members has a lower maximum cylinder range (as compared to lens without such structure). Rather, the angularly varying phase members apply the cylinder power to a band surrounding the corrective meridian, thereby providing a continuous band that makes the lens may tolerant due to misalignment. As shown, in this embodiment, the sensitivity of the ophthalmic apparatus with the angularly varying phase members is less by 20% as compared to a lens without the angularly varying phase members. And, at 10 degrees of misalignment (or off-axis operation) from the targeted corrective axis, the modulation transfer function (MTF) degradation for the ophthalmic apparatus configured with the angularly varying phase member is still acceptable. In this example, the ophthalmic apparatus configured with the angularly varying phase members is configured as a monofocal toric lens with 4.0 Diopters cylindrical power. Here, the MTF is at 100 lp/-mm and has a spatial frequency equivalent to 30 c/degree for an emmetropia eye with 20/20 visual acuity. The performance of the toric IOL with the angularly varying phase member at 5 degrees off-meridian (e.g., line 602a) has comparable MTF performance to a similar toric IOL without the angularly varying phase structure at 2 degrees of misalignment (e.g., line 604a).
FIGS. 7A and 7B are diagrams of an ophthalmic apparatus 100 (e.g., an intraocular toric lens) that includes angularly-varying phase members 102 (reflective, diffractive, or both) that disperse light therethrough to a plurality of foci that are offset radially to one another so as to provide an extended tolerance to misalignments of the lens 100 when implanted in an eye in accordance with another illustrative embodiment. As shown in FIGS. 7A-7B, the apparatus 100 has an asymmetric height profile 702 in which the maximum height of the face of the apparatus differs between the different zones. To demonstrate the asymmetric height profile 702, representative echelette in zones 120b and 120c of an example refractive surface is shown. In zone 120b, the height of a representative echelette 704 is shown to be greater than the height of a representative echelette 706 in zone 120c.
In some embodiments, the asymmetric height profile 702 may be configured to direct light to a plurality foci. For example, the apparatus 100 with the asymmetric height profile 702 may be used for as a trifocal lens. In other embodiments, the apparatus with the asymmetric height profile 702 is used for a quad-focal lens. In some embodiments, the apparatus 100 with the asymmetric height profile 702 is used for a double bi-focal lens. In some embodiments, the apparatus 100 with the asymmetric height profile 702 is used for a mono-focal lens. In some embodiments, the apparatus 100 with the asymmetric height profile 702 is used for a combined bi-focal and tri-focal lens. In some embodiments, the apparatus 100 with the asymmetric height profile 702 is used for an anterior bifocal and a posterior tri-focal lens. In some embodiments, the apparatus 100 with the asymmetric height profile 702 is used for a posterior bifocal and an anterior tri-focal lens.
FIGS. 8 and 9 illustrate a plurality of height profiles of the angularly-varying phase members 102 of the lens in accordance with various illustrative embodiments. As shown in FIG. 8, the height profile is symmetric at each meridian in that the maximum height (shown as 802, 804, and 806) at the face of the lens are the same. As shown in FIG. 9, the height profile is asymmetric in that the maximum height at the face of the lens are different.
FIG. 10 illustrates an example multi-focal intraocular lens 1000 configured with angularly varying phase members in accordance with an illustrative embodiment. As shown, the lens 1000 provides a mono-focal at corrective meridian Θ=0° and 180°. In addition, the lens 1000 provides a second mono-focal at corrective meridian Θ=90° and −90°. In addition, the lens 1000 provides a first bi-focal at Θ=−45° and 135°. In addition, the lens 1000 provides a second bi-focal at Θ=45° and −135°. In some embodiments, the lens is refractive. In other embodiments, the lens is diffractive.
With the angularly varying phase members, images at all meridians (Θ=0°, Θ=45°, Θ=90°, Θ=135°, Θ=180°, Θ=−135°, Θ=−90°, and 0=)−45° reach a 20/20 “uncorrected distance visual acuity” (UDVA). FIGS. 11 and 12 are diagrams illustrating added cylindrical power, from the angularly varying phase members, in the radial and angular position in accordance with the illustrative embodiments.
FIG. 11 illustrates added cylinder power by the angularly varying phase members for a multi-focal intraocular lens configured as a bifocal. As shown in FIG. 11, for a given cylindrical power (e.g., 6.0 Diopters), the angularly varying phase members add varying magnitudes of cylinder powers between, e.g., 0.125 Diopters and 1.0 Diopter between the peak corrective meridian Θ=0° (e.g., the astigmatic meridian) and the non-peak corrective meridian Θ=45° in which minimum cylinder power is added at Θ=0° (where the meridian is a mono-focal, shown at points 1102), and in which the maximum cylinder power is added at Θ=45° where the meridian is configured as a bi-focal (shown along line 1104). The added power to the non-peak corrective meridian increases the tolerance of the IOL to misalignment from the corrective axis.
FIG. 12 illustrates a trifocal intraocular lens with the angularly varying phase members in accordance with an illustrative embodiment. As shown in FIG. 12, the added varying cylinder power is added between the peak corrective meridian Θ=0° and the non-peak corrective meridian Θ=45°, as shown in FIG. 11. As further shown, a trifocal optics 1202 is added. The trifocal 1202 does not have an angularly varying phase member.
FIG. 13 illustrates an ophthalmic apparatus 1300 having angularly varying phase members to extend tolerance of ocular astigmatism by varying extended depth of focus at each meridian through an optimized combination of angularly and zonally diffractive phase structure on each meridian in accordance with an illustrative embodiment.
As shown in FIG. 13, the ophthalmic apparatus 1300 includes a first corrective meridian 90°*N°±α° (variable 01), where α is the extended tolerance of the first corrective meridian, and N is an integer. For N=0, 1, 2, 3, 4, the meridians includes 0° (1302), ±90° (1304), and 180° (1306). In some embodiments, a is ±3°, ±3.25°, ±3.5°, ±3.75°, ±4°, ±4°, ±4.25°, ±4.5°, ±4.75°, ±5°, ±5.25°, ±5.5°, ±5.75°, ±6°, ±6.25°, ±6.5°, ±6.75°, ±7°, ±7.25°, ±7.5°, ±7.75°, ±8°, ±8.25°, ±8.5°, ±8.75°, ±9°, ±9.25°, ±9.5°, ±9.75°, and ±10°. Where α is ±10°, the IOL would have a dynamic and optimized efficiency for correcting astigmatic effects that can tolerate misalignment of the cylindrical axis up to 10 (variable 08) degrees in either counter clockwise or clockwise rotation. It is contemplated that terms noted as variables may be varied, modified, or adjusted, in some embodiments, to produce desired or intended effects and benefits, as discussed herein.
FIG. 14 illustrates a table for a trifocal IOL configured with the angularly varying phase members. As shown in FIG. 14, the light transmission efficiency at a first corrective foci 1402 (e.g., at the retina) is about 100% while other foci along the same meridian is about 0%. This configuration establishes the first corrective meridian 1402 at Θ=0° and other meridians, e.g., Θ=±90° and, e.g., 180°, as a monofocal with additional chromatic aberration reduction.
In addition, at meridian 45°*N°±α° (1408 and 1410) (variable 02), the light transmission efficiency varies for three point of focus (shown as 1408a, 1408b, and 1408c) (e.g., at the front of the retina, at the retina, and behind the retina) of the optics at this meridian. For N=1, 2, 3, 4, the meridians includes ±45° and ±90°. As shown in FIG. 14, at the first foci (1408a) (e.g., at the front of the retina), the light transmission efficiency is about 25% (variable 03), and the optics includes added power that matches the ocular astigmatic power corresponding to the human astigmatism tolerance level. At the second foci (1408b) (e.g., at the retina), the light transmission efficiency is about 50% (variable 04) efficiency. At the third foci (1408c) (e.g., behind the retina), the light transmission efficiency is about 25% (variable 05), and the optics include added power having the same magnitude as the first foci though with an opposite sign. At other meridians, the focus on the retina has efficiency between 0.5% and 100% (variable 06) and the other focus not on the retina has efficiency between 0% and 25% (variable 07). In some embodiments, the light transmission efficiency are varied via different materials that may be stacked, e.g., as a stacking lens, where each layer is comprised of a different material. In other embodiments, the angularly-varying phase members may be comprised of a material or materials that have a variation in refractive index, a gradient index, or a programmed index, for example liquid crystal which creates transmission efficiency change.
The thickness profile T1(r, θ) for the IOL may be characterized by Equation 2 below.
T1(r,θ)=t1(r)|COS2(θ)|+t2(r)|SIN2(θ)| (Equation 2)
According to Equation 2, t1(r) and t2(r) are step heights for each zone, and they each matches an optical path difference (OPD) from −2λ to 2κ, where λ is the design wavelength at zonal radius r.
Equation 2 may be simplified and represented as Equation 3, where A is adjusts the size of the extended operating band of the angularly varying phase member, and B provides an offset of the center of the angularly varying phase member with respect to a pre-defined reference frame (e.g., Θ=0° or Θ=90°, etc.).
T1(r,θ)=COS[Aθ+B] (Equation 3)
Example: Angularly Varying Phase Members That Varies Along Angular Position
FIGS. 15-18, comprising, FIGS. 15A, 15B, 16A, 16B, 16C, 17A, 17B, 18A, 18B, and 18C, depict the ophthalmic apparatus with angularly varying phase members in accordance with other illustrative embodiments. According to these embodiments, the angularly varying phase members are located with a fixed-size zone and varies only along the angular position. In FIGS. 15A, 15B, 16B, 16C, 17A, 17B, 18B, and 18C, height profiles are illustrated via representative echelette elements for a diffractive surface.
As shown in FIGS. 15A-15B, the ophthalmic apparatus includes a plurality of zones 1502 (shown as 1502a, 1504b, and 1504c). The zones 1502a, 1502b, 1502c defined at a first corrective meridian Θ=0° and 180° (1506) has approximately the same zone length (i.e., cylinder power) as the zones 1502a, 1502b, 1502c defined at a second meridian Θ=45° and 135° (1508). As further shown in FIGS. 16A, 16B, and 16C, the height profile (shown as 1602, 1604, 1606, 1608, 1610, and 1612) of the face of the lens varies along the angular position θ=0°, θ=9°, θ=18°, θ=27°, θ=36°, and θ=45°.
FIGS. 17A and 17B illustrate an ophthalmic apparatus having a height profile across the multiple zones (shown as 1702a, 1702b, and 1702c) in which the height of the face of the lens angularly varies with the meridian axes. As shown in FIGS. 18A, 18B, and 18C, the height profile (shown as 1802, 1804, 1806, 1808, 1810, and 1812) of the face of the lens varies along the angular position θ=0°, θ=9°, θ=18°, θ=27°, θ=36°, and θ=45°.
Referring back to FIG. 13, in another aspect, the ophthalmic apparatus includes a plurality of alignment markings, including a first set of alignment markings 1302 and a second set of alignment markings 1304, that indicate the corrective meridian of the lens. In some embodiments, the first set of alignment markings 1302 is located at the meridian θ=0° and 180°. The second set of alignment markings 1304 may include corresponding sets of markets to define a tolerance band for the lens. In some embodiments, the second set of alignment markings 1304 is located at ±5° radial offset from the first set of alignment markings 1302.
Example: Refractive Lens Surfaces with Angularly Varying Phase Members
FIGS. 19A and 19B are diagrams of an exemplary ophthalmic apparatus 1900 that includes refractive angularly-varying phase members 102 in accordance with another illustrative embodiment. A height profile 1902 (shown as 1902a and 1902b) of the refractive surface 1904 (shown as 1904a and 1904b) is shown at Θ=0° and Θ=45°. As shown in FIG. 19A, the first height profile 1902a of the lens transitions into the second height profile 1904b. Here, the inflection point of the refractive surface is shown to vary spatially (i.e., changing radial values) and angularly (i.e., changing height or thickness values).
FIGS. 20A, 20B, 20C, 20D, and 20E illustrate a plurality of exemplary height profiles of the anterior or posterior face across the angularly phase members of the ophthalmic apparatus of FIGS. 19A-19B, in accordance with an illustrative embodiment. That is, the height profile is shown between the first high power meridian (at Θ=0°) and the operational edge of the angularly varying phase members (e.g., at Θ=±α, e.g., Θ=10° and 0=)−10° in accordance with an illustrative embodiment. In FIG. 20B, representative height profiles at Θ=0° (2002); Θ=2° (2004); Θ=4° (2006); Θ=6° (2008); Θ=8° (2010); and Θ=10° (2012) (also shown in FIG. 20A) are provided as cross-sections of the echelette at the different meridians shown in FIG. 20A. As shown, the height profiles at axes nearby to the first high power meridian (e.g., between ±10°) have a similar shape, as the first high power meridian. The height profile varies in a continuous gradual manner (e.g., having a sine and cosine relationship) along the radial direction. This can be observed in FIGS. 20B and 20C. In FIG. 20B, the overall refractive profile is shown, and in FIG. 20C, an inflection point 2014 (e.g., shown as points 2014a, 2014b, 2014c, 2014d, 2014e, and 2014f) defined at a given zone boundary is shown. This transition of the inflection points 2014 may be described as a cosine-based or sine-based function, or a function derived from a combination thereof.
The thickness profile T1(r, θ) for the refractive design may be characterized by Equation 4 below.
T1(r,θ)=t1(r)|COS2(θ)|+t2(r)|SIN2(θ)| (Equation 4)
According to Equation 4, t1(r) and t2(r) are the add power for each zone, and they each match optical power needs from −200 D to +5.0 D, for a design wavelength at zonal radius r.
FIG. 20C illustrates a first portion of the height profiles (near the optical axis) at Θ=0° (202); Θ=2° (204); Θ=4° (206); Θ=6° (208); Θ=8° (210); and =10° (212) superimposed next to one another. This variation of the height profile along the radial axis provides a lens region that focuses light at the desired foci and other foci nearby. To this end, radial offset (i.e., misalignment) of the ophthalmic apparatus from the center axis of a desired corrective meridian results in its nearby regions focusing the light to the desired foci.
In FIGS. 20D and 20E, example height profiles of the lens surface between Θ=0° and Θ=45° are shown. As shown in FIGS. 20D and 20E, the height profiles of the angularly varying phase member vary as a cosine-based or sine-based function. In some embodiments, the height profiles of the lens surface between Θ=45° and Θ=90° are mirrored at Θ=45° to the lens surface between Θ=0° and Θ=45°.
It is contemplated that refractive angularly varying phase member can vary symmetrically or asymmetrically, for a given zone, as well as between the multiple zones, as described, for example, in relation to FIGS. 8, 9, 16, and 18. That is, inflection points in the refractive surface at a given zone (e.g., a first zone) may vary, in the radial and angular direction, at the same rate with inflection points in the refractive surface at another zone (e.g., a second zone), as described in relation to the diffractive element of FIG. 8. In addition, in some embodiments, inflection points in the refractive surface at a given zone (e.g., a first zone) may vary, in the radial and angular direction, at a different rate with inflection points in the refractive surface at another zone (e.g., a second zone), as described in relation to the diffractive element of FIG. 9. In addition, in some embodiments, inflection points in the refractive surface at a given zone (e.g., a first zone) may vary, only in the angular direction, at a same or different rate with inflection points in the refractive surface at another zone (e.g., a second zone), as described in relation to the diffractive element of FIGS. 16 and 18.
Example: Multi-Focal Refractive Ophthalmic Apparatus with Diffractive or Refractive Angularly Varying Phase Members
FIG. 21, comprising FIGS. 21A, 21B, and 21C, is a diagram illustrating an exemplary ophthalmic apparatus 2100 that includes refractive or diffractive angularly-varying phase members 102, in accordance with another illustrative embodiment.
The angularly-varying phase member 102, in FIG. 21, can be characterized as Equation 5, where r(θ) is the contour radius for the given meridian added power A(θ), wavelength λ, zone number n, and the scaling value s(θ), all at meridian θ.
r
(
θ
)
=
2
·
n
·
s
(
θ
)
·
λ
A
(
θ
)
(
Equation
5
)
In FIG. 21A, the lens 2100 provides a mono-focal at corrective meridian Θ=0° and 180°. In addition, the lens 2100 provides a second mono-focal at corrective meridian Θ=90° and −90°. In some embodiments, the mono-focal corrective meridian Θ=0° and 180° and the mono-focal corrective meridian Θ=90° and −90° have the same focal point. In other embodiments, the mono-focal corrective meridian Θ=0° and 180° and the mono-focal corrective meridian Θ=90° and −90° have different focal points.
Referring still to FIG. 21A, the lens 2100 provides a first bi-focal at Θ=−45° and 135° and, in addition, the lens 2100 provides a second bi-focal at Θ=45° and −135°. In some embodiments, the bi-focal corrective meridian −45° and 135° and the bi-focal corrective meridian Θ=45° and −135° have the same focal point. In other embodiments, the bi-focal corrective meridian −45° and 135° and the bi-focal corrective meridian 45° and −135° have different focal points.
As shown in FIG. 21B, intraocular lens 2100 has a base cylindrical power (e.g., 6.0 Diopters) to which angularly varying phase members having additional cylindrical power are added. The angularly varying phase members adds the cylindrical power having an extended tolerance of operation, for example, up to ±10° (of misalignment) from a given corrective meridian (e.g., an astigmatism meridian). As shown, the additional cylindrical power are added to a surface sag coordinate (shown as “sag(z)”). Specifically, the added cylindrical power (shown as “Value θ” in FIG. 21B), for each given angular position θ (2104), in this exemplary lens design, varies between about −200 Diopters and about −0.01 Diopters (shown as “Value θ” 2104) and between about 0.01 Diopters and about 6.0 Diopters (shown as “Value θ” 2106). The added power is provided over the surface of the intraocular lens having a diameter 2108 of 6.0 mm (millimeters). Radial positions 2114 (shown as 2114a and 2114b) are illustratively shown in FIGS. 21A and 21B. As shown in FIG. 21C, the added cylindrical power, along each radial positions (e.g., at Θ=−180° to Θ=180°), at radial positions 2114a and 2114b are provided.
Referring still to FIG. 21B, the added cylindrical power of 0.01 Diopters and about 6.0 Diopters and of −200 Diopters and about −0.01 Diopters is added via a refractive surface 2110 (e.g., as shown having an “ETA(r, θ) surface profile”). As shown in FIG. 21B, the refractive surface 2110 has a modified thickness value at sag surface value of “0” at the center of the lens. The sag surface value, as shown, decreases to generate the refractive surface profile, as for example, described in relation to FIG. 4D. It should be appreciated that the provided sag surface profile is merely illustrative. It is contemplated that equivalent refractive surfaces may be produced on various lens surface in additive or subtractive manner, as shown, for example, but not limited to, in relation to FIGS. 4A-4D.
Referring still to FIG. 21B, the added cylindrical power profile 2112 may be used to provide distant vision and emmetropia correction for a given patient. Emmetropia generally refers to a state in which the eye is relaxed and focused on an object more than 20 feet away in which light coming from the focus object enters the eye in a substantially parallel, and the rays are focused on the retina without effort. To this end, image at all meridian can reach 20/20 “uncorrected distance visual acuity” (UDVA).
Referring to back to FIG. 21A, the added cylindrical power profile 2112 of FIG. 21B is added at angular position Θ=Θ° (shown as “Θ=Θ° 2116”). To this end, the angularly varying phase members, as described herein, for example, including those described in relation to FIGS. 1-2, 7-9, and 15-20 may be applied at any angular position along the lens surface, to generate a multi-focal lens.
Referring still to FIG. 21A, in some embodiment, a complementary angularly varying phase member may be added in a given quadrant of the lens. For example, an intraocular lens may include a first angularly varying phase member at an angular position between Θ=45° and Θ=90°; the intraocular lens may include a second angularly varying phase member at an angular position between Θ=0° and Θ=45° in which the second angularly varying phase member is mirrored, along the axis Θ=45°, with respect to the first angularly varying phase member.
Example: Alignment Markings for Extended Tolerance Band
FIGS. 22A and 22B depicts an ophthalmic apparatus with an extended tolerance astigmatic band. The ophthalmic apparatus includes the second set of alignment markings 1308 as discussed in relation to FIG. 13.
Example Method of Generating Surfaces with Angularly-Varying Phase Members
FIG. 23 is diagram of a method 2300 to generate, via a processor, the surface with the angularly-varying phase members, in accordance with an illustrative embodiment. As shown in FIG. 23, the method 2300 includes generating (2302), via a processor, an initial design (2304) comprising a base surface (with base cylindrical power) and sectional enhancements (with added cylindrical power) and iteratively generating (2308) and evaluating, a revised design (2310), generated according to an optimization routine (2308) that is performed based on sectional parameters, until pre-defined image quality metric values and boundary parameter are achieved. The sectional enhancements power of the initial design and the iterative design is the surface with the angularly-varying phase members.
Referring still to FIG. 23, the method 2300 includes generating (2302) a first design (2304) via i) initial surface optical parameter, including a) base surface optical parameters 2312 and b) sectional surface optical parameters 2314, and ii) the pre-defined image quality metric values 2316. The base surface optical parameters 2312 include, in some embodiments, parameters associated with a radius of curvature for the toric lens (shown as “Radius of curvature” 2318), parameters associated with conic constant and aspheric coefficients (shown as “Conic constant” 2320), parameters associated with base cylinder power (shown as “Cylinder power” 2322), and parameters associated lens and/or coating material characteristics such as refractive index (shown as “Refractive index” 2324). Other parameters may be used as part of the base surface optical parameters 2312. The section surface optical parameters 2314, in some embodiments, includes parameters associated with sectional added power and meridian characteristics (shown as “Sectional add power” 2328) and parameters associated with high order aberration characteristics, e.g., Zernike aberrations above second-order (shown as “High order aberrations” 2328).
Referring still to FIG. 23, the parameters associated with the sectional added power 2326, in some embodiments, include a cylindrical power, for a given optical zone. In some embodiments, the cylindrical power for the added power are all refractive, all diffractive, or a combination of both. The parameters associated with the high order aberration characteristics 2328, in some embodiments, include polynomial values (e.g., based on Zernike polynomials, Chebyshev polynomials, and combinations thereof) or characteristics such as polynomial orders and types as well as meridian boundaries for the high order aberrations. The high order aberration is constraint, e.g., from minimum to maximum cylindrical power over one or more meridian sections. In some embodiments, the high order aberrations is constraint or designated to a meridian, e.g., that corresponds to a corneal irregular geometry or limited retinal area functions. Such customization has a potential to truly benefit patients having cornea with or without astigmatism, patients with local Keratoconus with or without astigmatism, patients with glaucoma, patients with retinal macular degeneration (AMD), and the like.
Referring still to FIG. 23, the parameters associated with the pre-defined image quality metric value 2316 includes parameters associated with expected image quality metric (shown as “Expected image quality metric values” 2330) and parameters associated with special boundary restrain parameters (shown as “Special boundary restrain parameters” 2332). In some embodiments, image quality metric is based a comparison of a base polychromatic diffraction MTF (modular transfer function) (e.g., tangential and sagittal) to a number of error polychromatic diffraction MTFs values, e.g., where one or more polychromatic diffraction MTFs are determined for one or more misalignments of the generated toric lens from its intended operating meridians, e.g., at 5-degree misalignment and at 10-degree misalignment.
Referring still to FIG. 23, the initial design (2304) is evaluated (2334a) to determine image quality metric values (e.g., the base polychromatic diffraction MTF, e.g., at 0 degree misalignment) and the error polychromatic diffraction MTFs, e.g., at the 5 and 10 degrees misalignment) and boundary parameters. The determined image quality metric values are evaluated (2336) to determine whether the image quality metric values and boundary parameters meet an expected outcome, e.g., a value of 0.2. In some embodiments, the expected outcome is whether there is no cut off through spatial frequency beyond 100 cpd. Upon determining that the condition is met, the method 2300 is stop (2338). It is contemplated that other image quality metrics may be used, e.g., the optical transfer function (OTF), phase transfer function (PhTF), and etc.
Where the condition is not met, the method 2300 adjusts (2308) sectional parameters to be optimized and rerun the optimization to generate the revised design 2310. In some embodiments, the adjusted sectional parameters may include power A(θ), wavelength λ, zone number n, and the scaling value s(θ), as for example, shown in FIGS. 19A-19B, 20A-20E, 21A-21C, which is expressed as
r
(
θ
)
=
2
·
n
·
s
(
θ
)
·
λ
A
(
θ
)
,
where r(θ) is the contour radius for the given meridian added power A(θ), wavelength λ, zone number n, and the scaling value s(θ), all at meridian θ.
Referring back to FIG. 23, the method 2300 then includes evaluating (2334b) the revised design 2310 to determine image quality metric values (e.g., the base polychromatic diffraction MTF, e.g., at 0 degree misalignment) and the error polychromatic diffraction MTFs, e.g., at the 5 and 10 degrees misalignment) and boundary parameters, as discussed in relation to step 2334a, and re-evaluating (2336) whether the revised image quality metric values and boundary parameters meet the expected outcome, as discussed in relation to step 2336.
In some embodiments, the method 2300 is performed in an optical and illumination design tool such as Zemax (Kirkland, Wash.). It is contemplated that the method 2300 can be performed in other simulation and/or design environment.
Ophthalmic Apparatus Having Extended Tolerance Band with Freeform Refractive Surfaces
FIG. 24 is a diagram of an example freeform-polynomial surface area 2402 that provides extended rotational tolerance, in accordance with an illustrative embodiment. The freeform-polynomial surface area 2402 is mapped to a surface of an ophthalmic apparatus 324 (not shown—see FIG. 4) to provide cylinder power to the ophthalmic apparatus, e.g., for the correction an astigmatism, or the like, such that the ophthalmic apparatus can be subjected to a cylindrical axis misalignment (CAM) (shown via arrow 2406) of the meridian 2404 (also referred to as “axis’ 2404) of up to 10 degrees without degradation of the corrective performance (e.g., with regard to visual acuity (VA) or modular transfer function (MTF)), as compared to when there no misalignment.
Notably, the freeform-polynomial surface area 2402 is defined as a mathematical expression that is a combination of one or more polynomial expressions each having a distinct complex orders. Examples of polynomial expressions includes, but are not limited to, Chebyshev-based polynomial expression, Zernike-based polynomial expression. The combination of one or more polynomial expressions may be used to define an angularly-varying phase member that is tolerant of cylindrical axis misalignment (CAM) up to an extended band of operation without degradation of the corrective performance such as visual acuity (VA) or modular transfer function (MTF) as compared to when there no misalignment.
In some embodiments, one or more polynomial expressions are combined with different complex orders and the results are tested to determine that corrective performance (e.g., with regard to visual acuity (VA) or modular transfer function (MTF) are met.
As used herein, a “Chebyshev-based polynomial” refers to a mathematical expression that is expressed as a combination of one or more Chebyshev polynomial components in which the Chebyshev polynomial components is a Chebyshev polynomials of the first kind and/or a Chebyshev polynomials of the second kind. The Chebyshev polynomial can include, as a combination, the Chebyshev polynomial component along with another polynomial expression (e.g., Zernike polynomials, combinations of Zernike polynomials, other polynomials, or combination thereof, and etc.)
As used herein, a “Zernike-based polynomial” refers to a mathematical expression that is expressed as a combination of one or more Zernike polynomial components in which the Zernike polynomial components is a Zernike polynomial. The Zernike polynomial can include, as a combination, a Zernike polynomial component along with another polynomial expression (e.g., Chebyshev polynomials, combinations of Chebyshev polynomials, other polynomials, or combination thereof, and etc.)
Referring back to FIG. 24, the freeform-polynomial surface area 2402 of FIG. 24 is defined as a mathematical expression that is a combination of one or more polynomial expressions each having a distinct complex orders. In some embodiments, the freeform-polynomial surface area 2402 is defined as a second thickness value T(x,y) for a cylinder surface superimposed on a first thickness value (e.g., a base or typical aspheric height profile), in which T(x, y) is defined by Equation 6:
T(x,y)=Σ{c(i,j)*cos(i*arccos(t))*cos(j*arccos(t))} (Equation 6)
where c(i, j) is a coefficient based on i and j, which are each orders of the polynomial and expressed as integers, x and y are spatial locations on the freeform-polynomial surface area, and t is a normalized parameter for angular positions having values between −1.0 and 1.0. The base thickness value can be from a typical aspheric thickness profile. In some embodiments, the coefficient c(i,j) is based on a basis function that adjust the normalized amplitudes of each respective location of the lens as represented by the Chebyshev polynomial. A Chebyshev polynomial (of the first kind), along one dimension, can be expressed as Tk(x)=cos(k*cos−1(x)), where k is an order that is an integer. In two dimension, a Chebyshev polynomial (of the first kind) can be expressed as Tij(x, y)=COS(i*cos−1(x))*COS(j*cos−1(y)), where x and y values have a numerical value between −1.0 and +1.0, and Tij are normalized to a value of −1.0 and +1.0.
Referring still to FIG. 24, the freeform-polynomial surface area 2402 of FIG. 24 is derived from Chebyshev polynomials as shown in Equation 6 having i-order of 0 to 6 and a j-order of 0 to 6. Equation 7 shows the expanded mathematical expression for the second freeform-polynomial surface area 2402 of FIG. 24.
T
(
x
,
y
)
=
c
(
0
,
0
)
*
cos
(
0
*
cos
-
1
(
t
)
)
*
cos
(
0
*
cos
-
1
(
t
)
)
+
c
(
0
,
1
)
*
cos
(
0
*
cos
-
1
(
t
)
)
*
cos
(
1
*
cos
-
1
(
t
)
)
+
c
(
0
,
2
)
*
cos
(
0
*
cos
-
1
(
t
)
)
*
cos
(
2
*
cos
-
1
(
t
)
)
+
c
(
0
,
3
)
*
cos
(
0
*
cos
-
1
(
t
)
)
*
cos
(
3
*
cos
-
1
(
t
)
)
+
c
(
0
,
4
)
*
cos
(
0
*
cos
-
1
(
t
)
)
*
cos
(
4
*
cos
-
1
(
t
)
)
+
c
(
0
,
5
)
*
cos
(
0
*
cos
-
1
(
t
)
)
*
cos
(
5
*
cos
-
1
(
t
)
)
+
c
(
0
,
6
)
*
cos
(
0
*
cos
-
1
(
t
)
)
*
cos
(
6
*
cos
-
1
(
t
)
)
+
c
(
1
,
0
)
*
cos
(
1
*
cos
-
1
(
t
)
)
*
cos
(
0
*
cos
-
1
(
t
)
)
+
c
(
1
,
1
)
*
cos
(
1
*
cos
-
1
(
t
)
)
*
cos
(
1
*
cos
-
1
(
t
)
)
+
c
(
1
,
2
)
*
cos
(
1
*
cos
-
1
(
t
)
)
*
cos
(
2
*
cos
-
1
(
t
)
)
+
c
(
1
,
3
)
*
cos
(
1
*
cos
-
1
(
t
)
)
*
cos
(
3
*
cos
-
1
(
t
)
)
+
c
(
1
,
4
)
*
cos
(
1
*
cos
-
1
(
t
)
)
*
cos
(
4
*
cos
-
1
(
t
)
)
+
c
(
1
,
5
)
*
cos
(
1
*
cos
-
1
(
t
)
)
*
cos
(
5
*
cos
-
1
(
t
)
)
+
c
(
1
,
6
)
*
cos
(
1
*
cos
-
1
(
t
)
)
*
cos
(
6
*
cos
-
1
(
t
)
)
+
…
c
(
6
,
0
)
*
cos
(
6
*
cos
-
1
(
t
)
)
*
cos
(
0
*
cos
-
1
(
t
)
)
+
c
(
6
,
1
)
*
cos
(
6
*
cos
-
1
(
t
)
)
*
cos
(
1
*
cos
-
1
(
t
)
)
+
c
(
6
,
2
)
*
cos
(
6
*
cos
-
1
(
t
)
)
*
cos
(
2
*
cos
-
1
(
t
)
)
+
c
(
6
,
3
)
*
cos
(
6
*
cos
-
1
(
t
)
)
*
cos
(
3
*
cos
-
1
(
t
)
)
+
c
(
6
,
4
)
*
cos
(
6
*
cos
-
1
(
t
)
)
*
cos
(
4
*
cos
-
1
(
t
)
)
+
c
(
6
,
5
)
*
cos
(
6
*
cos
-
1
(
t
)
)
*
cos
(
5
*
cos
-
1
(
t
)
)
+
c
(
6
,
6
)
*
cos
(
6
*
cos
-
1
(
t
)
)
*
cos
(
6
*
cos
-
1
(
t
)
)
=
c
(
0
,
0
)
+
c
(
0
,
1
)
*
cos
(
cos
-
1
(
t
)
)
+
c
(
0
,
2
)
*
cos
(
cos
(
2
*
cos
-
1
(
t
)
)
+
c
(
0
,
3
)
*
cos
(
3
*
cos
-
1
(
t
)
)
+
c
(
0
,
4
)
*
cos
(
4
*
cos
-
1
(
t
)
)
+
c
(
0
,
5
)
*
cos
(
5
*
cos
-
1
(
t
)
)
+
c
(
0
,
6
)
*
cos
(
6
*
cos
-
1
(
t
)
)
+
c
(
1
,
0
)
*
cos
(
cos
-
1
(
t
)
)
+
c
(
1
,
1
)
*
cos
(
cos
-
1
(
t
)
)
*
cos
(
cos
-
1
(
t
)
)
+
c
(
1
,
2
)
*
cos
(
cos
-
1
(
t
)
)
*
cos
(
2
*
cos
-
1
(
t
)
)
+
c
(
1
,
3
)
*
cos
(
cos
-
1
(
t
)
)
*
cos
(
3
*
cos
-
1
(
t
)
)
+
c
(
1
,
4
)
*
cos
(
cos
-
1
(
t
)
)
*
cos
(
4
*
cos
-
1
(
t
)
)
+
c
(
1
,
5
)
*
cos
(
cos
-
1
(
t
)
)
*
cos
(
5
*
cos
-
1
(
t
)
)
+
c
(
1
,
6
)
*
cos
(
cos
-
1
(
t
)
)
*
cos
(
6
*
cos
-
1
(
t
)
)
+
…
c
(
6
,
0
)
*
cos
(
6
*
cos
-
1
(
t
)
)
*
cos
(
0
*
cos
-
1
(
t
)
)
+
c
(
6
,
1
)
*
cos
(
6
*
cos
-
1
(
t
)
)
*
cos
(
1
*
cos
-
1
(
t
)
0
+
c
(
6
,
2
)
*
cos
(
6
*
cos
-
1
(
t
)
)
*
cos
(
2
*
cos
-
1
(
t
)
)
+
c
(
6
,
3
)
*
cos
(
6
*
cos
-
1
(
t
)
)
*
cos
(
3
*
cos
-
1
(
t
)
)
+
c
(
6
,
4
)
*
cos
(
6
*
cos
-
1
(
t
)
)
*
cos
(
2
*
cos
-
1
(
t
)
)
+
c
(
6
,
3
)
*
cos
(
6
*
cos
-
1
(
t
)
)
*
cos
(
3
*
cos
-
1
(
t
)
)
+
c
(
6
,
4
)
*
cos
(
6
*
cos
-
1
(
t
)
)
*
cos
(
4
*
cos
-
1
(
t
)
)
+
c
(
6
,
5
)
*
cos
(
6
*
cos
-
1
(
t
)
)
*
cos
(
5
*
cos
-
1
(
t
)
)
+
c
(
6
,
6
)
*
cos
(
6
*
cos
-
1
(
t
)
)
*
cos
(
6
*
cos
-
1
(
t
)
)
(
Equation
7
)
Referring still to FIG. 24, a power pupil map with uniformly distributed contour lines of the calculated cylindrical power for the freeform-polynomial surface area 2402 is shown. The corrective meridian is located at about Θ=0° (shown as axis 104) with a center portion of the freeform-polynomial surface area 2402 being disposed at this Θ position. Off-center structures of the freeform-polynomial surface area 2402 extend from the center structure in a gradually varying manner (e.g., as defined by the combination of Chebyshev polynomials described in relation to Equation 7) to apply cylinder power to a band of meridians surrounding the corrective meridian enabling the ophthalmic apparatus to operate off-axis (or off-meridian) to the corrective meridian (e.g., the astigmatism meridian). Notably, there are no more than 0.6-Diopter difference between any neighboring uniformly distributed contour lines.
FIG. 25 illustrates an example operation of the freeform-polynomial surface area of FIG. 24 when subjected to misalignment, in accordance with an illustrative embodiment. The freeform-polynomial surface area 2402, as a diffractive or refractive structure, in some embodiments, varies the extended depth of focus to a plurality of nearby focus points. To this end, light directed to such nearby focus points are thus directed to the desired focus point when the ophthalmic apparatus is subjected to a rotational offset from a primary intended axis of alignment, thereby extending the rotational tolerance of the apparatus to an extended tolerance band. In FIG. 25, a portion (2502) of the freeform-polynomial surface area 2402 has a focus point 2504 (e.g., referred to as a “main focus point” 2504, e.g., to correct for an astigmatism) that is generated by a region about the center 2506 of the portion 2502 of the freeform-polynomial surface area 2402. In this example, a nearby region 2508 of that portion 2502 has a focus point 2510 (e.g., referred to as an “auxiliary focus point” 2510) that is offset from the main focus point 2504. When the freeform-polynomial surface area 2402 is rotated about axis 2512, e.g., as misalignment 2402 is introduced to the corrective meridian Θ=0° (2404), the focus point 2510 of region 2508 is moved towards the main focus point 2504, thereby extending the band of operation of the freeform-polynomial surface area 2402. Remarkably, this extended tolerance astigmatism band delivers cylinder power to correct for the astigmatism for a range of meridians (e.g., up to ±10° as shown in FIG. 24, though can be more in other embodiments), thereby eliminating any need for additional corrective measures (e.g., supplemental corrective devices or another surgical intervention) when the implanted ophthalmic apparatus is not perfectly aligned to the desired astigmatism meridian in the eye.
Put another way, the freeform-polynomial surface area 2402 facilitates an extended band of the corrective meridian that has minimal, and/or clinically acceptable, degradation of the visual acuity and modulation transfer function when the ophthalmic apparatus is subjected to rotational misalignment between the astigmatic axis and a center axis of the corrective meridian.
Corneal Irregular Geometry or Limited Retinal Area Functions
In another aspect, the freeform-polynomial surface area 2402 of FIG. 24 is optimized to purposely place accumulated high surface amplitude to non-functional retinal area so that the functional areas can fully benefit the enhanced image quality stability of the freeform-polynomial surface design. Examples of non-functional retinal areas may include, but not limited to, areas of gradual loss of sight (e.g., associated with glaucoma or retinal macular degeneration (e.g., age-related macular degeneration, AMD). The freeform-polynomial surface area 2402 of FIG. 24 can be similarly optimized to emphasize needs for a cornea that irregularly shaped with or without astigmatism and with local Keratoconus with or without astigmatism.
In particular, the freeform-polynomial surface area 2402, in some embodiments, are optimized by further modification of the weights (e.g., c(i,j) as discussed in relation to Equation 6 or Equation 7) in the combined Chebyshev polynomials and the Zernike or extended polynomials used to characterize or design the geometry of the freeform-polynomial surface area 2402. As noted above, the c(i,j) is used to scale the normalized surface generated by the Chebyshev polynomials or the Zernike polynomials. C(i,j) is also used to adjust and/or emphasize cylindrical power for corneal irregular geometry or limited retinal area functions.
As shown in Equations 6 and 7, the freeform-polynomial surface area 2402 is defined by a surface sag (or power) that is a weighted sum of Chebyshev polynomials (Zernike and other polynomials may be used with, or in substitute of, the Chebyshev polynomials) with the coefficient c(i, j) (e.g., shown in Equation 6).
The coefficient c(i, j) are weights that may be modified or set based on specific knowledge of the local coordinates of the special cornea irregularity. To this end, the coefficient c(i, j) allows the specific polynomials to be freely shifted in space (i.e., spatial) domain to match the local coordinates. The coefficient c(i, j) as weights for each polynomial can be a function of local coordinates function and implemented as a filter with low-, medium-, or high-pass transmission operations.
Results of IOL with Exemplified Freeform-Polynomial Surfaces
FIG. 26 shows a combined cylinder map generated from the combination of the IOL cylindrical power (provided, in part, via the freeform-polynomial surface) combined with the corneal cylindrical power through meridians. As discussed above with reference to FIG. 24, and as can be seen from the IOL cylinder map through meridians around the clock, there is remarkably no more than about 0.6 D difference for any continuous uniformly distributed contour lines at the IOL plane. The IOL SE is 20 D at the IOL plane. The IOL cylinder map of FIG. 24 is combined with the IOL SE to provide the overall IOL cylindrical map. This overall IOL cylindrical map is then combined with a test corneal cylindrical power. The resulting combination (shown in FIG. 26) remarkably shows little variation in the cylinder map of the combined IOL cylindrical power the corneal cylindrical power. That is, the astigmatism associated with test corneal cylindrical power has been attenuated and/or corrected for by the IOL cylindrical power provided, in part, by the freeform-polynomial surface.
FIGS. 27A and 27B each shows calculated MTF values as spatial frequencies of an exemplified IOL in a physiological eye model with astigmatic cornea in different cylindrical axis misalignment (CAM) situations between the cornea and the IOL for an iris pupil. Notably, as shown in FIGS. 27A and 27B, the modulation transfer function (MTF) is maintained across the extended range of alignment for a lens configured with the freeform-polynomial surface area 2402 of FIG. 24. Specifically, in FIGS. 27A and 27B, the MTFs for misalignment at 0 degrees, 5 degrees, and 10 degrees are shown (shown as “CAM=0 Deg” 2702, “CAM=5 Deg” 2704, and “CAM=10 Deg” 2706). In FIG. 27A, the iris pupil is about 3.0 mm. In FIG. 27B, the iris pupil is about 5.0 mm.
Notably, as can also be seen from the MTF curves, there are no cut-offs of the spatial frequency beyond 100 cpd (cycles per degree), which for an IOL with SE (Spherical Equivalent) of 20D (Diopters), this spatial frequency is approximately 30 cpd.
Example of Multi-Zonal IOL with the Exemplified Freeform-Polynomial Surfaces
In another aspect, a multi-zonal IOL with freeform-polynomial surfaces is disclosed. In some embodiments, the multiple zonal structure includes one or more zonal surfaces defines by Chebyshev-based polynomials while other zonal surfaces are defined by other polynomials (e.g., Zernike and Chebyshev polynomials).
In some embodiments, the freeform-polynomial surface area (e.g., the second or third height profile) symmetrically spans part of the optical face of the apparatus). FIG. 28A shows a diagram of a freeform-polynomial surface area (e.g., the second or third height profile) of a second optical zone that symmetrically spans part of the optical face of the apparatus, in accordance with an illustrative embodiment.
As shown in FIG. 28A, the ophthalmic apparatus includes an optical face 2802 (e.g., the portion of the face surface of the ophthalmic apparatus that include corrective optical structures) that includes the one or more optical zones 2804 (shown as “optical zone 1” 2804a and “optical zone 2” 2804b). The first zone of the optical face has a boundary defined by a first axis 2806 of the face and a second axis 2808 of the face (e.g., wherein the first axis is orthogonal to the second axis), and each of the x-spatial locations at value −1.0 and at value 1.0 is located at a first radial position along the first axis between a center location 2810 of the ophthalmic apparatus and the boundary, and each of the y-spatial locations at value −1.0 and at value 1.0 is located at the first radial position along the second axis between the center location of the ophthalmic apparatus and the boundary. As shown, the “optical zone 1” 2804a has a first T(x,y) height profile (e.g., as described in relation to Equation 6) that is superimposed over, e.g., the base or typical aspherical height profile. In some embodiments, the “optical zone 1” 2804a has a surfaces defined by other polynomials (e.g., Zernike, or combination of Zernike and Chebyshev polynomials).
In some embodiments, the second “optical zone 2” 2804b is characterized by a third height profile T2(x,y) (e.g., an extra height profile associated with cylinder power) superimposed on a first height profile (e.g. a base or typical aspheric height profile), the third height profile being defined as:
T2(x,y)=Σ{c2(i2,j2)*cos(i2*arccos(t2))*cos(j2*arccos(t2))} (Equation 8)
where c2(i2, j2) is a coefficient based on i2 and j2, which are each integers (e.g., ranging between 0 and 10), x and y are spatial locations on the second freeform-polynomial surface area and has values between −1.0 and 1.0, and t2 is a normalized parameter having values between −1.0 and 1.0 (e.g., associated with the intended correction meridian). In some embodiments, the “optical zone 2” 2804b has a surfaces defined by otherpolynomials (e.g., Zernike, or combination of Zernike and Chebyshev polynomials).
In some embodiments, the freeform-polynomial surface area (e.g., the second or third height profile) asymmetrically spans part of the optical face of the apparatus. That is, the first zone of the optical face has a boundary defined by a first axis of the face and a second axis of the face (e.g., wherein the first axis is orthogonal to the second axis). Each of the x-spatial locations at value −1.0 and at value 1.0 is located at a first radial position along the first axis between a center location of the ophthalmic apparatus and the boundary, and each of the y-spatial locations at value −1.0 and at value 1.0 is located at a second radial position along the second axis between the center location of the ophthalmic apparatus and the boundary, where the first radial position and the second radial position are different.
FIG. 28B shows a diagram of a freeform-polynomial surface area (e.g., the second or third height profile) of a second optical zone that symmetrically spans part of the optical face of the apparatus, in accordance with an illustrative embodiment.
As shown in FIG. 28B, the ophthalmic apparatus includes the optical face 2802 (e.g., the portion of the face surface of the ophthalmic apparatus that include corrective optical structures) that includes the one or more optical zones 28004 (shown as “optical zone 1” 2804a and “optical zone 2” 2804b) that are asymmetric one another. The first zone of the optical face has a boundary defined by a first axis 2806 of the face and a second axis 2808 of the face (e.g., wherein the first axis is orthogonal to the second axis), and each of the x-spatial locations at value −1.0 and at value 1.0 is located at a first radial position along the first axis between a center location 2810 of the ophthalmic apparatus and the boundary, and each of the y-spatial locations at value −1.0 and at value 1.0 is located at the first radial position along the second axis between the center location of the ophthalmic apparatus and the boundary. As shown, the “optical zone 1” 2804a has a first T(x,y) height profile (e.g., as described in relation to Equation 1) that is superimposed over, e.g., the base or typical aspherical height profile. In some embodiments, the “optical zone 1” 2804a has a surfaces defined by other polynomials (e.g., Zernike, or combination of Zernike and Chebyshev polynomials).
In some embodiments, the second “optical zone 2” 2804b is characterized by a third height profile T2(x,y) (e.g., as described in relation to Equation 7) that are each superimposed over, e.g., the base or typical aspherical height profile. In some embodiments, the “optical zone 2” 2804b has a surfaces defined by other polynomials (e.g., Zernike, or combination of Zernike and Chebyshev polynomials).
It is contemplated that other zone shapes may be used for a given zone of the multiple zones. Example of other zone shape include, but not limited to, a rectangle, diamond, and various freeform polygons.
Referring back to FIG. 23, the diagram also shows a method to generate, via a processor, the freeform-polynomial surface area of FIG. 24, in accordance with an illustrative embodiment. As shown in FIG. 23, the method includes generating (2302), via a processor, an initial design (2304) comprising a base surface (with base cylindrical power) and sectional enhancements for freeform-polynomial surface area—with added cylindrical power derived from the Chebyshev-based polynomial expression, Zernike-based polynomial expression—and iteratively generating (2306) and evaluating, a revised design (2310), generated according to an optimization routine (2308) that is performed based on sectional parameters, until pre-defined image quality metric values and boundary parameter are achieved. The sectional enhancements power of the freeform-polynomial surface area initial design and the iterative freeform-polynomial surface area design are the ETA polynomial surface of FIG. 24.
Referring still to FIG. 23, the parameters associated with the sectional added power 2326 for the freeform-polynomial surface area, in some embodiments, include a mathematical expression comprising a combination of one or more polynomial expressions (e.g., Chebyshev-based polynomial expression, Zernike-based polynomial expression, etc.) each having a distinct complex orders. In some embodiments, the cylindrical power for the added power are all refractive. The parameters associated with the high order aberration characteristics 1128, in some embodiments, include polynomial values (e.g., based on Zernike polynomials, Chebyshev polynomials, and combinations thereof) or characteristics such as polynomial orders and types as well as meridian boundaries for the high order aberrations. The high order aberration is constrained, e.g., from minimum to maximum cylindrical power over one or more meridian sections. In some embodiments, the high order aberrations is constrained or designated to a meridian, e.g., that corresponds to a corneal irregular geometry or limited retinal area functions. In other embodiments, the high order aberrations may be introduced as weights a freeform polynomial weights to form the freeform-polynomial surface area. In such embodiments, the high order aberrations and its meridian locations on the lens surface may be optimized prior to the freeform polynomial weights being determined to facilitate a customized design that is tailored for a given patient (i.e., particularly in view of corneal irregular geometry or limited retinal area functions). Such customization has a potential to truly benefit patients having cornea with or without astigmatism, patients with local Keratoconus with or without astigmatism, patients with glaucoma, patients with retinal macular degeneration (AMD), and the like.
The adjusted sectional parameters (e.g., 2308) may include adjusting values for i and j of the Chebyshev or Zernike polynomials, as discussed in reference to Equation 6 or Equation 7. In some embodiments, only one value of i or j of the Chebyshev or Zernike polynomials is adjusted to generate each design variant. In other embodiments, the values of i and j of the Chebyshev or Zernike polynomials are adjusted concurrently.
Ophthalmic Apparatus with Extended Tolerance Band by Modifying Refractive Powers in Uniform Meridian Distribution
FIG. 29 is a diagram of cylindrical map of a polynomial surface 2902 (also referred to as an ETA polynomial surface 2902) that is uniformly arranged over a plurality of meridians that provides extended rotational tolerance, in accordance with an illustrative embodiment. The polynomial surface 2902 is mapped to a surface of an ophthalmic apparatus 324 (not shown—see FIG. 4) to provide cylinder power to the ophthalmic apparatus, e.g., for the correction an astigmatism, or the like, such that the ophthalmic apparatus can be subjected to a cylindrical axis misalignment (CAM) (shown via arrow 2904) of the meridian 2906a of up to 10 degrees without degradation of the corrective performance (e.g., with regard to visual acuity (VA) or modular transfer function (MTF)), as compared to when there no misalignment.
Notably, the polynomial surface 2902 is uniformly arranged, in this embodiment, over a plurality of meridians 2906 for every 0.5 D (diopters). It should be appreciated that other values can be used. In some embodiments, the polynomial surface 2902 is uniformly arranged over a plurality of meridians 2906 for every 0.41 D (diopters). In some embodiments, the polynomial surface 2902 is uniformly arranged over a plurality of meridians 2906 for every 0.42 D (diopters). In some embodiments, the polynomial surface 2902 is uniformly arranged over a plurality of meridians 2906 for every 0.44 D (diopters). In some embodiments, the polynomial surface 2902 is uniformly arranged over a plurality of meridians 2906 for every 0.46 D (diopters). In some embodiments, the polynomial surface 2902 is uniformly arranged over a plurality of meridians 2906 for every 0.45 D (diopters). In some embodiments, the polynomial surface 2902 is uniformly arranged over a plurality of meridians 2906 for every 0.48 D (diopters). In some embodiments, the polynomial surface 2902 is uniformly arranged over a plurality of meridians 2906 for every 0.52 D (diopters). In some embodiments, the polynomial surface 2902 is uniformly arranged over a plurality of meridians 2906 for every 0.54 D (diopters). In some embodiments, the polynomial surface 2902 is uniformly arranged over a plurality of meridians 2906 for every 0.56 D (diopters). In some embodiments, the polynomial surface 2902 is uniformly arranged over a plurality of meridians 2906 for every 0.58 D (diopters). In some embodiments, the polynomial surface 2902 is uniformly arranged over a plurality of meridians 2906 for every 0.60 D (diopters). The number of the added power at which the meridian are uniformly distributed is set at an individual eye's tolerance of meridian power change such as the astigmatic or cylinder power. This value changes individually, up to 1.0 D (diopters), but on average a comfortable tolerance is about 0.5 D at the IOL plane.
FIG. 30 is a diagram of the ETA polynomial surface 2902 of FIG. 29 shown with the plurality of uniformly arranged meridians 206 (shown as 2906a-2906ee), in accordance with an illustrative embodiment. As shown in FIG. 30 (and in FIG. 29), the ETA polynomial surface 2902, in this example, includes three regions 3002, 3004, 3006 (the center shown as 3002a, 3004a, and 3006a) of corrective cylindrical power—the first region 3002 spanning between meridians 2906aa and 2906dd; the second region 3004 spanning between meridians 2906d and 2906g; and the third region 3006 spanning between meridians 2906k and 2906n. As shown, each of the meridians (2906a-2906q and 2906x-2906a) are uniformly arranged (i.e., uniformly spaced at various angular positions—here about 11 degrees apart) for every 0.5 D (diopters).
As shown in FIG. 30, meridian 2906a is located at about 90 degrees; meridian 2906b is located at about 79 degree; meridian 2906c is located at about 67 degree; meridian 2906d is located at about 55 degree; meridian 2906e is located at about 44 degree; meridian 2906f is located at about 33 degree; meridian 2906g is located at about 24 degree; meridian 2906h is located at about 11 degree; meridian 2906i is located at about 0 degree; meridian 2906j is located at about −12 degree; meridian 2906k is located at about −24 degree; meridian 29061 is located at about −36 degree; meridian 2906m is located at about −47 degree; meridian 2906n is located at about −56 degree; meridian 2906o is located at about −67 degree; meridian 2906p is located at about −79 degree; and meridian 2906q is located at about −90 degree; meridian 2906r is located at about −100 degree; meridian 2906s is located at about −112 degree; meridian 2906t is located at about −125 degree; meridian 2906u is located at about −135 degree; meridian 2906v is located at about −145 degree; meridian 2906w is located at about −158 degree; meridian 2906x is located at about −176 degree; meridian 2906y is located at about 168 degree; meridian 2906z is located at about 157 degree; meridian 2906aa is located at about 145 degree; meridian 2906bb is located at about 133 degree; meridian 2906cc is located at about 123 degree; meridian 2906dd is located at about 113 degree; and meridian 2906ee is located at about 101 degree.
It is contemplated that the ETA polynomial surface 102 may include more than three regions of corrective cylindrical power, e.g., a fourth region, a fifth region, and etc. In such embodiments, the regions between the corrective meridians may be uniformly reduced, e.g., to about 10 degrees apart, about 9 apart, about 8 degrees apart, about 7 degrees apart, and etc.
Table 1 illustrates examples of toric IOL designs with meridians uniformly distributed for a same added power, for a 0.25 D same added power, for a 0.5 D same added power, for a same 0.75 D same added power, and for a same 1.0 D same added power.
TABLE 1
Number of
Added Power (in
Max Added
meridians (from
Max number
diopters) between
Power
low to low power
of corrective
each meridian
(diopters)
over ¼ of the lens)
regions
0.25
D
4 D
16
(4/0.25)
6
0.5
D
4 D
8
(4/0.5)
3
0.75
D
4 D
5.3
(4/0.75)
3
1.0
D
4 D
4
(4/1)
3
As shown in Table 1, when the meridians are uniformly arranged for a same added power of 0.5 D, for a 4 D base, there are 8 meridians between the high power meridian and the low power meridian in a quadrant of the polynomial surface between meridian 2906a and 2906i. This allows for up to 3 corrective regions on the polynomial surface, as shown in FIG. 30. In another embodiment, when the meridians are uniformly arranged for a same added power of 0.75 D, for a 4 D base, there are 5.4 meridians between the high power meridian and the lower power. This allows up to 3 corrective regions of the polynomial surface. In another embodiment, when the meridians are uniformly arranged for a same added power of 0.25 D, for a 4 D base, there are 16 meridians between the high power meridian and the lower power. This allows up to 6 corrective regions of the polynomial surface. In another embodiment, when the meridians are uniformly arranged for a same added power of 1.0, for a 4 D base, there are 2 meridians between the high power meridian and the lower power. This allows up to 3 corrective regions of the polynomial surface, which has the high power meridian center located at meridians 2906e, 2906s, and 2906cc.
FIG. 31 is a profile of the polynomial surface of FIG. 29 with the plurality of uniformly arranged meridians, in accordance with an illustrative embodiment. As shown in FIG. 31, each meridian (e.g., 2906b, 2906c, 2906d, 2906e, 2906f) is defined by an angular position that is uniformly arranged, about 11 degrees apart, for every 0.5 D (diopters). In addition, the majority of meridian power change, from one meridian to the next, generates a change of more than 0.6 D power difference (shown as 3104). The result is a profile that is more uniformly sloped that provided extended range of operation beyond about 5 degrees of misalignment (e.g., up to 10 degrees misalignment), as compared to a conventional or macro regular cylindrical surface with power changes according to COS(2*theta) trend, for a given difference between two meridians, shown as profile 3106. As shown in profile 3106, the meridian distribution is not uniform. Specifically, the meridian (in degrees) from the minimum power meridian—namely 0 degrees (3108a)—is located at a 20.7-degree position (3108b), a 30-degree position (3108c), a 37.8-degree position (3108d), a 45.0-degree position (3108e), a 52.2-degree position (3108f), a 60-degree position (3108g), a 69.3-degree position (3108h), a 90.0-degree position (3108i), and etc., in a periodic trend, which provides a non-uniform meridian difference of about 20.7 degrees (between 3108a and 3108b), about 9.3 degrees (between 3108b and 3108c), about 7.8 degrees (between 3108c and 3108d), about 7.2 degrees (between 3108d and 3108e), about 7.2 degrees (between 3108e and 3108f), about 7.8 degree (between 3108f and 3108g), about 9.3 (between 3108g and 3108h), and about 20.7 degree (between 3108h and 3108i).
Referring still to FIG. 31, off-center structures of the polynomial surface 2902 extend from the center structure in a gradually varying manner to apply cylinder power to a band of meridians surrounding the corrective meridian enabling the ophthalmic apparatus to operate off-axis (or off-meridian) to the corrective meridian (e.g., the astigmatism meridian). Notably, there are no more than 0.6-Diopter difference between any neighboring uniformly distributed contour lines.
In some embodiments, the polynomial surface 2902 is defined by a combination of spline or polynomial (e.g., a Zernike polynomial, a Chebyshev polynomial, or a combination of both) that is constrained by the condition of the meridians being uniformly arranged apart for a same given added diopter of power up to 1.0 D (diopters).
FIG. 32 illustrates an example operation of the polynomial surface 2902 of FIG. 29 when subjected to misalignment, in accordance with an illustrative embodiment. The polynomial surface 2902, as a diffractive or refractive structure, in some embodiments, varies the extended depth of focus to a plurality of nearby focus points. To this end, light directed to such nearby focus points are thus directed to the desired focus point when the ophthalmic apparatus is subjected to a rotational offset from a primary intended axis of alignment, thereby extending the rotational tolerance of the apparatus to an extended tolerance band. In FIG. 32, a portion (3202) of the polynomial surface 2902 has a focus point 3204 (e.g., referred to as a “main focus point” 3204, e.g., to correct for an astigmatism) that is generated by a region about the center 3206 of the portion 3202 of the polynomial surface 2902. In this example, a nearby region 3208 of that portion 3202 has a focus point 3210 (e.g., referred to as an “auxiliary focus point” 3210) that is offset from the main focus point 3204. When the polynomial surface 2902 is rotated about axis 2912, e.g., as misalignment 2906 is introduced to the corrective meridian Θ=0° (2904), the focus point 3210 of region 3208 is moved towards the main focus point 3204, thereby extending the band of operation of the polynomial surface 2902. Remarkably, this extended tolerance astigmatism band delivers cylinder power to correct for the astigmatism for a range of meridians (e.g., up to ±10° as shown in FIG. 29, though can be more in other embodiments), thereby eliminating any need for additional corrective measures (e.g., supplemental corrective devices or another surgical intervention) when the implanted ophthalmic apparatus is not perfectly aligned to the desired astigmatism meridian in the eye.
Put another way, the polynomial surface 2902 facilitates an extended band of the corrective meridian that has minimal, and/or clinically acceptable, degradation of the visual acuity and modulation transfer function when the ophthalmic apparatus is subjected to rotational misalignment between the astigmatic axis and a center axis of the corrective meridian.
Results of IOL with Exemplified Freeform-Polynomial Surfaces
FIG. 33 shows a combined cylinder map generated from the combination of the IOL cylindrical power (provided, in part, via the polynomial surface) combined with the corneal cylindrical power through meridians. FIG. 34 shows the combined cylinder map of FIG. 33 with the meridians shown in FIG. 30 superimposed thereon.
As discussed above with reference to FIG. 29, and as can be seen from the IOL cylinder map through meridians around the clock, there is remarkably no more than about 0.6 D difference for any continuous uniformly distributed contour lines at the IOL plane. The IOL SE is 20 D at the IOL plane. The IOL cylinder map of FIG. 29 is combined with the IOL SE to provide the overall IOL cylindrical map. That is, the astigmatism associated with test corneal cylindrical power has been attenuated and/or corrected for by the IOL cylindrical power provided, in part, by the polynomial surface.
FIGS. 35A and 35B each shows calculated MTF values as spatial frequencies of an exemplified IOL 100 in a physiological eye model with astigmatic cornea in different cylindrical axis misalignment (CAM) situations between the cornea and the IOL for an iris pupil. Notably, as shown in FIGS. 35A and 35B, the modulation transfer function (MTF) is maintained across the extended range of alignment for a lens configured with the freeform-polynomial surface area 2902 of FIG. 29. Specifically, in FIGS. 35A and 35B, the MTFs for misalignment at 0 degrees, 5 degrees, and 10 degrees are shown (shown as “CAM=0 Deg” 3502, “CAM=5 Deg” 3504, and “CAM=10 Deg” 3506). In FIG. 35A, the iris pupil is about 3.0 mm. In FIG. 35B, the iris pupil is about 5.0 mm.
Notably, as can also be seen from the MTF curves, there are no cut-offs of the spatial frequency beyond 100 cpd (cycles per degree), which for an IOL with SE (Spherical Equivalent) of 20D (Diopters), this spatial frequency is approximately 30 cpd.
Corneal Irregular Geometry or Limited Retinal Area Functions
In another aspect, the polynomial surface 2902 of FIG. 29 is optimized to purposely place accumulated high surface amplitude (also referred to high order aberration) to non-functional retinal area so that the functional areas can fully benefit the ETA designs, that is, the enhanced image quality stability. Examples of non-functional retinal areas may include, but not limited to, areas of gradual loss of sight (e.g., associated with glaucoma or retinal macular degeneration (AMID).
Referring to FIG. 30, an accumulated high surface amplitude results at area 3008 to provide enhanced image quality stability for the three corrective regions 3002, 3004, 3006 that have uniform distributions discussed herein. In some embodiments, the corrective regions (e.g., 3002, 3004, 3006) effectively span over a region greater than 90 degrees to angular extent. Confined by a finite surface region, it is contemplated that the accumulated (high) surface amplitude area 3008 is purposely positioned (in a manner similar to the positioning of the corrective regions 3002, 3004, 3006) to coincide, e.g., with areas of limited retinal functionality that may be present with a given patient. That is, the accumulated (high) surface area is specifically optimized optically to target the special optical needs of the entire eye on this area.
FIG. 36 is a surface SAG map of the polynomial surface 2902 of FIG. 29, in accordance with an illustrative embodiment.
Referring back to FIG. 23, the diagram also shows a method to generate, via a processor, the polynomial surface of FIG. 29, in accordance with an illustrative embodiment. As shown in FIG. 23, the method includes generating (2302), via a processor, an initial freeform polynomial design (2304) comprising a base surface (with base cylindrical power) and sectional enhancements (with added cylindrical power in which each meridian is uniformly arranged for a same given added power) and iteratively generating (2306) and evaluating, a revised freeform polynomial design (1310), generated according to an optimization routine (2308) that is performed based on sectional parameters, until pre-defined image quality metric values and boundary parameter are achieved. The sectional enhancements power of the initial freeform polynomic design and the iterative freeform polynomic design are the ETA polynomial surface of FIG. 29.
The section surface optical parameters 1314 of the freeform polynomial surface, in some embodiments, includes parameters associated with sectional added power and meridian characteristics (shown as “Sectional add power” 1328) and parameters associated with high order aberration characteristics, e.g., Zernike aberrations above second-order (shown as “High order aberrations” 1328).
Referring still to FIG. 23, the parameters associated with the sectional added power 1326, in some embodiments, include a cylindrical power, for a given optical zone, for a same given added power in which meridians are uniformly arranged. In some embodiments, the cylindrical power for the added power are all refractive. The parameters associated with the high order aberration characteristics 1328, in some embodiments, include polynomial values (e.g., based on Zernike polynomials, Chebyshev polynomials, and combinations thereof) or characteristics such as polynomial orders and types as well as meridian boundaries for the high order aberrations. The high order aberration is constrained, e.g., from minimum to maximum cylindrical power over one or more meridian sections. In some embodiments, the high order aberrations is constrained or designated to a meridian, e.g., that corresponds to a corneal irregular geometry or limited retinal area functions. In such embodiments, the high order aberrations and its meridian locations on the lens surface may be optimized prior to the meridians for the uniform regions are determined to facilitate a customized design that is tailored for a given patient (i.e., particularly in view of corneal irregular geometry or limited retinal area functions). Such customization has a potential to truly benefit patients having cornea with or without astigmatism, patients with local Keratoconus with or without astigmatism, patients with glaucoma, patients with retinal macular degeneration (AMD), and the like.
Referring still to FIG. 23, the parameters associated with the pre-defined image quality metric value 1316 includes parameters associated with expected image quality metric (shown as “Expected image quality metric values” 1330) and parameters associated with special boundary restrain parameters (shown as “Special boundary restrain parameters” 1332). In some embodiments, image quality metric is based a comparison of a base polychromatic diffraction MTF (modular transfer function) (e.g., tangential and sagittal) to a number of error polychromatic diffraction MTFs values, e.g., where one or more polychromatic diffraction MTFs are determined for one or more misalignments of the generated toric lens from its intended operating meridians, e.g., at 5-degree misalignment and at 10-degree misalignment.
Referring still to FIG. 23, the initial design (1304) is evaluated (1334a) to determine image quality metric values (e.g., the base polychromatic diffraction MTF, e.g., at 0 degree misalignment) and the error polychromatic diffraction MTFs, e.g., at the 5 and 10 degrees misalignment) and boundary parameters, e.g., as shown in FIGS. 35A and 35B. The determined image quality metric values are evaluated (1336) to determine whether the image quality metric values and boundary parameters meet an expected outcome, e.g., a value of 0.2. In some embodiments, the expected outcome is whether there is no cut off through spatial frequency beyond 100 cpd. Upon determining that the condition is met, the method 1300 is stop (1338). It is contemplated that other image quality metrics may be used, e.g., the optical transfer function (OTF), phase transfer function (PhTF), and etc.
Where the condition is not met, the method 1300 adjusts (1308) sectional parameters to be optimized and rerun the optimization to generate the revised design 1310. The adjusted sectional parameters may include meridians locations and meridian spacing among neighboring meridians. The optimization may include allowing the uniform contour lines to move from one meridian to a next meridian up based on an upper limit amount and a lower limit amount. As shown in FIG. 30, the uniform contour line 3010 is show transitioning from meridian 2906m to meridian 2906n. The transition is constrained to occur along a specific radial position and without abrupt transition points.
Referring back to FIG. 23, the method 300 then includes evaluating (2334b) the revised design 2310 to determine image quality metric values (e.g., the base polychromatic diffraction MTF, e.g., at 0 degree misalignment) and the error polychromatic diffraction MTFs, e.g., at the 5 and 10 degrees misalignment) and boundary parameters, as discussed in relation to step 2334a, and re-evaluating (2336) whether the revised image quality metric values and boundary parameters meet the expected outcome, as discussed in relation to step 2336.
The present technology may be used, for example, in the Tecnis toric intraocular lens product line as manufactured by Abbott Medical Optics, Inc. (Santa Ana, Calif.).
It is not the intention to limit the disclosure to embodiments disclosed herein. Other embodiments may be used that are within the scope and spirit of the disclosure. In some embodiments, the above disclosed angularly varying phase members may be used for multifocal toric, extended range toric, and other categorized IOLs for extended tolerance of astigmatism caused by factors including the cylindrical axis misalignment. In addition, the above disclosed angularly varying phase members may be applied to spectacle, contact lens, corneal inlay, anterior chamber IOL, or any other visual device or system.
Exemplary Computer System
FIG. 37 is a diagram of an example computing device configured to generate the surface with the angularly-varying phase members. As used herein, “computer” may include a plurality of computers. The computers may include one or more hardware components such as, for example, a processor 3721, a random access memory (RAM) module 3722, a read-only memory (ROM) module 3723, a storage 3724, a database 3725, one or more input/output (I/O) devices 3726, and an interface 3727. Alternatively and/or additionally, controller 3720 may include one or more software components such as, for example, a computer-readable medium including computer executable instructions for performing a method associated with the exemplary embodiments. It is contemplated that one or more of the hardware components listed above may be implemented using software. For example, storage 3724 may include a software partition associated with one or more other hardware components. It is understood that the components listed above are exemplary only and not intended to be limiting.
Processor 3721 may include one or more processors, each configured to execute instructions and process data to perform one or more functions associated with a computer for indexing images. Processor 3721 may be communicatively coupled to RAM 3722, ROM 3723, storage 3724, database 3725, I/O devices 3726, and interface 3727. Processor 3721 may be configured to execute sequences of computer program instructions to perform various processes. The computer program instructions may be loaded into RAM 3722 for execution by processor 3721. As used herein, processor refers to a physical hardware device that executes encoded instructions for performing functions on inputs and creating outputs.
RAM 3722 and ROM 3723 may each include one or more devices for storing information associated with operation of processor 3721. For example, ROM 3723 may include a memory device configured to access and store information associated with controller 3720, including information associated with IOL lenses and their parameters. RAM 3722 may include a memory device for storing data associated with one or more operations of processor 3721. For example, ROM 3723 may load instructions into RAM 3722 for execution by processor 3721.
Storage 3724 may include any type of mass storage device configured to store information that processor 3721 may need to perform processes consistent with the disclosed embodiments. For example, storage 3724 may include one or more magnetic and/or optical disk devices, such as hard drives, CD-ROMs, DVD-ROMs, or any other type of mass media device.
Database 3725 may include one or more software and/or hardware components that cooperate to store, organize, sort, filter, and/or arrange data used by controller 3720 and/or processor 3721. For example, database 3725 may store hardware and/or software configuration data associated with input-output hardware devices and controllers, as described herein. It is contemplated that database 3725 may store additional and/or different information than that listed above.
I/O devices 3726 may include one or more components configured to communicate information with a user associated with controller 3720. For example, I/O devices may include a console with an integrated keyboard and mouse to allow a user to maintain a database of images, update associations, and access digital content. I/O devices 3726 may also include a display including a graphical user interface (GUI) for outputting information on a monitor. I/O devices 3726 may also include peripheral devices such as, for example, a printer for printing information associated with controller 3720, a user-accessible disk drive (e.g., a USB port, a floppy, CD-ROM, or DVD-ROM drive, etc.) to allow a user to input data stored on a portable media device, a microphone, a speaker system, or any other suitable type of interface device.
Interface 3727 may include one or more components configured to transmit and receive data via a communication network, such as the Internet, a local area network, a workstation peer-to-peer network, a direct link network, a wireless network, or any other suitable communication platform. For example, interface 3727 may include one or more modulators, demodulators, multiplexers, demultiplexers, network communication devices, wireless devices, antennas, modems, and any other type of device configured to enable data communication via a communication network.
While the methods and systems have been described in connection with preferred embodiments and specific examples, it is not intended that the scope be limited to the particular embodiments set forth, as the embodiments herein are intended in all respects to be illustrative rather than restrictive.
Unless otherwise expressly stated, it is in no way intended that any method set forth herein be construed as requiring that its steps be performed in a specific order. Accordingly, where a method claim does not actually recite an order to be followed by its steps or it is not otherwise specifically stated in the claims or descriptions that the steps are to be limited to a specific order, it is no way intended that an order be inferred, in any respect. This holds for any possible non-express basis for interpretation, including: matters of logic with respect to arrangement of steps or operational flow; plain meaning derived from grammatical organization or punctuation; the number or type of embodiments described in the specification.
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16871296
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johnson & johnson surgical vision, inc.
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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 5th, 2022 05:11PM
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Apr 5th, 2022 05:11PM
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Johnson & Johnson
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Health Care
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Pharmaceuticals & Biotechnology
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nyse:jnj
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Johnson & Johnson
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Apr 5th, 2022 12:00AM
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Aug 26th, 2020 12:00AM
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https://www.uspto.gov?id=US11292644-20220405
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Dispensing closure
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A closure for a container having an opening for dispensing fluids contained therein. The closure includes a cap and a pivotable top component moveable between a closed and two opened positions. A pair of dispensing openings are in fluid communication with the associated container. A second dispensing opening and its associated channel has a larger cross section, perpendicular to a flow direction, than a first dispensing opening and its associated channel.
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11292644
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1. A closure for a container having an opening for dispensing fluids contained therein comprising:
a) a cap comprising a base plate arranged and configured to seal the opening of the associated fluid container and a pair of apertures, each aperture defined by a cylindrical tube extending from the base plate and in fluid communication with the associated container, and
b) a pivotable top component moveable between a closed and two opened positions, said pivotable top component:
i) mounted on the cap for pivotable motion about a single horizontal hinge axis and
ii) comprising a top plate and pair of dispensing pathways aligned with the cylindrical tubes of the cap; each dispensing pathway comprising a cylindrical plug extending from the top plate being sized to sealingly engage the inner surface of the associated cylindrical tube of the cap, a cylindrical sleeve extending from the top plate being sized to sealingly engage the outer surface of the associated cylindrical tube of the cap, a channel from an annular void between the cylindrical plug and cylindrical sleeve to a dispensing opening, wherein the horizontal hinge axis is disposed between the pair of dispensing pathways, wherein the dispensing opening is in fluid communication with the cylindrical tube and thereby the associated container, wherein a second dispensing opening and associated channel has a larger cross section, perpendicular to a flow direction, than a first dispensing opening and associated channel.
2. The closure of claim 1 wherein the first and second dispensing openings have substantially rectangular openings.
3. The closure of claim 1 wherein the first dispensing opening cross section, perpendicular to a flow direction, has an area of about 40% to about 75% of the second dispensing opening cross section, perpendicular to a flow direction.
4. The closure of claim 3 wherein the first dispensing opening cross section, perpendicular to a flow direction, has an area of about 60% to about 70% of the second dispensing opening cross section, perpendicular to a flow direction.
5. A closure for a container having an opening for dispensing fluids contained therein comprising:
a) a cap comprising an outer surface, an inner surface, a base plate arranged and configured to seal the opening of the associated fluid container, and a centrally disposed aperture defined by a cylindrical tube extending from a top surface of the base plate and in fluid communication with the associated container, and
b) a pivotable top component moveable between a closed and two opened positions, said pivotable top component:
i) mounted on the cap for pivotable motion about a single horizontal hinge axis and
ii) comprising
A) a top plate,
B) a pivotable top component rim,
C) a cylindrical plug extending from the top plate being sized to sealingly engage the inner surface of the cylindrical tube of the cap,
D) a cylindrical sleeve extending from the top plate being sized to sealingly engage the outer surface of the associated cylindrical tube of the cap,
E) a first channel from an annular void between the cylindrical plug and cylindrical sleeve to a first dispensing opening, and
F) a second channel from an annular void between the cylindrical plug and cylindrical sleeve to a second dispensing opening;
wherein the horizontal hinge axis is aligned with the cylindrical plug, wherein the dispensing openings are in fluid communication with the cylindrical tube and thereby the associated container, and the second dispensing opening and associated channel has a larger cross section, perpendicular to a flow direction, than the first dispensing opening and associated channel.
6. The closure of claim 5 wherein the first and second dispensing openings have substantially rectangular openings.
7. The closure of claim 5 wherein the first dispensing opening cross section, perpendicular to a flow direction, has an area of about 40% to about 75% of the second dispensing opening cross section, perpendicular to a flow direction.
8. The closure of claim 7 wherein the first dispensing opening cross section, perpendicular to a flow direction, has an area of about 60% to about 70% of the second dispensing opening cross section, perpendicular to a flow direction.
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8
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CROSS-REFERENCE TO RELATED APPLICATIONS
This application claims the benefit of U.S. provisional application 62/894058 filed on Aug. 30, 2019, the complete disclosure of which is hereby incorporated herein by reference for all purposes.
BACKGROUND OF THE INVENTION
Field of the Invention
The present invention relates to a device for containing and dispensing materials, particularly suited to be used with bottles or containers holding liquids, for instance, cosmetics, liquid soaps, shampoos, sun lotions and the like. More particularly, this invention relates to two-way dispenser closures with openings of different cross-sections for dispensing the container contents at different rates.
Description of Related Art
Closures for dispensing fluids from containers of liquid, such as shampoos, lotions, or sunscreens are available on the market. Types of dispensing closures, that are known include flapper closures, side pour closures, spice closures, sifters, disc top closures, turret closures, Yorker closures, snap top closures, and more. Lotion pumps are also useful for health and beauty applications.
The closure forms a dispenser for liquids which can be easily operated by the user. Many known dispensing closures have a single liquid dispensing pathway that the user opens by lifting or twisting a portion of the closure.
There are also numerous dispensing closures have more than one liquid dispensing pathway. These also are operated by the user at the time of dispensing liquid from the container.
Issues such as leakage and product remaining exposed in closure passages call for closures which are designed to avoid these issues.
BRIEF SUMMARY OF THE INVENTION
One aspect of the invention relates to a closure for a container having an opening for dispensing fluids contained therein. The closure includes a cap and a pivotable top component moveable between a closed and two opened positions. The cap includes a base plate arranged and configured to seal the opening of the associated fluid container and a pair of apertures. Each of the apertures is defined by a cylindrical tube extending from the base plate and in fluid communication with the associated container. The pivotable top component is mounted on the cap for pivotable motion about a horizontal hinge axis. It includes a top plate and pair of dispensing pathways aligned with the cylindrical tubes of the cap. Each dispensing pathway has a cylindrical plug extending from the top plate being sized to sealingly engage the inner surface of the associated cylindrical tube of the cap, a cylindrical sleeve extending from the top plate being sized to sealingly engage the outer surface of the associated cylindrical tube of the cap, a channel from an annular void between the cylindrical plug and cylindrical sleeve to a dispensing opening. Each dispensing opening is in fluid communication with the cylindrical tube and thereby the associated container. A second dispensing opening and associated channel has a larger cross section, perpendicular to a flow direction, than a first dispensing opening and associated channel.
A second aspect of the invention relates to a closure for a container having an opening for dispensing fluids contained therein. The closure includes a cap and a pivotable top component moveable between a closed and two opened positions. The cap has an outer surface, an inner surface, a base plate arranged and configured to seal the opening of the associated fluid container, and a centrally disposed aperture defined by a cylindrical tube extending from a top surface of the base plate and in fluid communication with the associated container. The pivotable top component is mounted on the cap for pivotable motion about a horizontal hinge axis. It has a top plate, a pivotable top component rim, a cylindrical plug extending from the top plate being sized to sealingly engage the inner surface of the cylindrical tube of the cap, a cylindrical sleeve extending from the top plate being sized to sealingly engage the outer surface of the associated cylindrical tube of the cap, a first channel from an annular void between the cylindrical plug and cylindrical sleeve to a first dispensing opening, and a second channel from an annular void between the cylindrical plug and cylindrical sleeve to a second dispensing opening. The dispensing openings are in fluid communication with the cylindrical tube and thereby the associated container, and the second dispensing opening and associated channel has a larger cross section, perpendicular to a flow direction, than the first dispensing opening and associated channel.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
FIG. 1 is a side view of an embodiment of a fluid dispensing bottle of the present invention;
FIG. 2 is an exploded perspective view of a first embodiment of a container closure of the present invention, showing a pivotable top component embodiment, and a cap embodiment;
FIG. 3 is a bottom view of the pivotable top component embodiment of FIG. 2;
FIG. 4 is a section view of the cap embodiment of FIG. 2;
FIG. 5 is a top view of the cap embodiment of FIG. 2;
FIG. 6 is a section view of the assembled first closure embodiment in the closed position;
FIG. 7 is a top view of the assembled first closure embodiment in the closed position;
FIG. 8 is a section view of the assembled first closure embodiment in the first opened position;
FIG. 9 is a section view of the assembled first closure embodiment in the second opened position;
FIG. 10 is a section view of an assembled second closure embodiment in the closed position; and
FIG. 11 is a section view of the assembled second closure embodiment in the first opened position.
DETAILED DESCRIPTION OF THE INVENTION
The present invention relates to relates to two-way dispenser closures with openings of different cross-sections for dispensing the container contents at different rates.
The presently disclosed subject matter will now be described more fully hereinafter with reference to the accompanying drawings and examples, in which representative embodiments are shown. The presently disclosed subject matter can, however, be embodied in different forms and should not be construed as limited to the embodiments set forth herein. The subject matter of our invention should be accorded the widest scope consistent with the features described herein. These embodiments are provided so this disclosure will be thorough and complete, and will fully convey the scope of the embodiments to those skilled in the art. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this presently described subject matter belongs.
As used herein the specification and the claims, the term “container”, also known as bottle, flagon, flask, jug or vial, an object that can be used to hold or transport liquids, solids, or gases. In the present invention, the container and the closure are independent entities.
The container closure described herein has several openings for dispensing fluids from the container at different rates. The closure has two parts, a cap and a pivotable top component. The cap has a base plate configured to seal the opening of the fluid container, and a pair of cylindrical tube apertures extending from the base plate which are in fluid communication with the contents of the container. The pivotable top component, moveable between a closed and two opened positions, is mounted on the cap for pivotable motion about a horizontal hinge axis and has a top plate and pair of dispensing pathways aligned with the cylindrical tubes of the cap. The dispensing pathways has cylindrical plugs (preferably hollow) extending from the top plate which are sized to sealingly engage the inner surface of the associated cylindrical tube of the cap, as well as cylindrical sleeves extending from the top plate being sized to sealingly engage the outer surface of the associated cylindrical tube of the cap. A pair of channels is formed by annular voids between the cylindrical plugs and cylindrical sleeves which lead to a pair of dispensing openings, wherein the dispensing openings are in fluid communication with the cylindrical tube and thereby the associated container. To allow for dispensing the container contents at different rates, the first dispensing opening and associated channel has a smaller cross section, perpendicular to a flow direction, than a second dispensing opening and associated channel
The two-way dispenser closure is designed to be attached to a container which contains a substance, preferably the top of the container. The substance may be a liquid including consumer products such as soaps, shampoos, sunscreens, lotions, cosmetics, and the like.
Referring now to the drawings wherein like reference numerals designate corresponding parts throughout the several views, FIG. 1 illustrates a side view of an embodiment of a fluid dispensing bottle 10 of the present invention. Dispensing bottle 10 includes a container 20 and a closure 30. Container 20 may be made of glass, metal, or plastic, in different shapes, colors, and sizes. Plastics include, but are not limited to, polyethylene terephthalate (PET), High-Density Polyethylene (HDPE), Polyvinyl Chloride (PVC), Low-Density Polyethylene (LDPE), or Polypropylene (PP). Plastics such as HDPE or LDPE are especially useful if dispensing bottle 10 is a squeeze bottle. A squeeze bottle is a type of bottle for dispensing a fluid, that is powered by squeezing the container through pressure exerted, e.g., by the user's hand. Its fundamental characteristic is that manual pressure applied to a resilient container is harnessed to compress fluid within it and thereby expel the fluid from the bottle.
Closure 30 has two parts, a cap 40 and a pivotable top component 60. FIG. 2 is an exploded perspective view of a first embodiment of a container closure 30, showing a pivotable top component embodiment 60, and a cap embodiment 40.
Pivotable top component 60, shown in perspective view in FIG. 2, and in bottom view in FIG. 3, has a top plate 61, a pivotable top component rim 65, a rocker arm 68, a pin 69, a first dispensing opening 86, and a second dispensing opening 96. Top plate 61 has a first surface 62 and a second surface 63. Pivotable top component rim 65 has a first surface 66 and a second surface 67. Protrusions 64 are disposed on second surface 67 of pivotable top component rim 65.
FIG. 3 also shows a first channel 84 and a second channel 94, as well as a horizontal hinge axis 70, cylindrical plugs 72a, 72b and cylindrical sleeves 76a, 76b. Cylindrical plugs 72a, 72b and cylindrical sleeves 76a, 76b extend from second surface 63 of top plate 61. The figure also shows that second dispensing opening 96 and associated second channel 94 have larger cross sections, perpendicular to a flow direction, than first dispensing opening 86 and associated channel first channel 84.
While the first channel 84 and second channel 94 are shown with substantially rectangular cross-sections, other cross-sections are contemplated including other quadrilateral forms (e.g., trapezoidal, square, and the like), triangular, continuous curves (e.g., circular, oval, and the like), and slots (having a width dimension substantially larger than a height dimension and with curved or substantially squared-off ends).
The cross-sectional area can be selected to dispense the contents of the container at a desired rate. For example, first dispensing opening 86 and associated channel first channel 84 may have a cross-sectional area of approximately 40% to 75% of a corresponding cross-sectional area of the second dispensing opening 96 and associated second channel 94. Preferably, the cross-sectional area of the first dispensing opening 86 and associated channel first channel 84 is approximately 60% to 70% of a corresponding cross-sectional area of the second dispensing opening 96 and associated second channel 94.
In one preferred embodiment, first dispensing opening 86 has a rectangular cross-section of 2 mm by 4 mm, and the second dispensing opening 96 has rectangular cross-section of 2 mm by 6 mm. Thus, the cross-sectional area of the first dispensing opening 86 is approximately 67% of a corresponding cross-sectional area of the second dispensing opening 96.
Horizontal hinge axis 70, as will be shown subsequently, provides the pivot axis for pivotable top component 60.
Cap 40, shown in perspective view in FIG. 2, in section view in FIG. 4, and in top view in FIG. 5, has an outer surface 41, an inner surface 42, a base plate 44, a rocker arm stabilizer 47, and a pin receiver 48. Protrusion guides 43 are blind holes disposed on inner surface 42 of cap 40. Rocker arm stabilizer 47, guides and limits the pivot path of the rocker arm 68, acting as a support point in the opening movement that releases first dispensing opening 86 and second dispensing opening 96. Base plate 44 has a top surface 45 and a bottom surface 46, a pair of cylindrical tubes 50a, 50b extending from top surface 45 of base plate 44, a container sealing ring 56, and a snap fit 57. Apertures 53a and 53b are defined by a cylindrical tube 50a and cylindrical tube 50b, respectively.
As seen in FIGS. 2 and 3, pivotable top component 60 includes protrusions 64 disposed next to each dispensing opening (86, 96). Cap 40 includes protrusion guides 43 disposed on cap inner surface 42. In this embodiment, protrusion guides 43 are racetrack shaped, having two lateral sides, and two vertical ends.
When cap 40 and a pivotable top component 60 are coupled together to form the closure 30, protrusions 64 are disposed inside their respective protrusion guides 43. The length of protrusion guides 43 is sufficient to allow the displacement of protrusions 64 during the movement of pivotable top component 60, and functions to provide guidance to the motion of pivotable top component 60. In addition, the end of the protrusion guides 43 are stop blocks when the pivotable top component 60 reaches its open position.
Closure 30 is designed to be attached to the top of container 20. Sealing ring 56 and snap fit 57 extend from bottom surface 46 of base plate 44. Snap fit 57 is the means of attaching closure 30 to container 20, and sealing ring 56 is a means of preventing leakage of the substance (e.g. liquid) disposed in container 20. Although a snap fit is described here as the means of attaching closure 30 to container 20, other means, such as screw threads or adhesives may also be used. The seal between closure 30 and container 20 may, in some embodiments, include a gasket.
Cylindrical tubes 50a, 50b extending from top surface 45 of base plate 44, each have an outer surface 51a and 51b, respectively, and an inner surface 52a and 52b, respectively. Cylindrical tubes 50a, 50b, as mentioned above, define a pair of apertures 53a, 53b through base plate 44. Apertures 53a, 53b are in fluid communication with the contents of container 20.
FIGS. 6 and 7 show views of the first embodiment of assembled closure 30. FIG. 6 is a section view of assembled closure 30, and FIG. 7 is a top view of assembled closure 30 when closure 30 is in the closed position. The figures show cylindrical plugs 72a, 72b which extend from second surface 63 of top plate 61, are sized to sealingly engage inner surfaces 52a and 52b, respectively, of the associated cylindrical tubes 50a, 50b of cap 40. Cylindrical sleeves 76a, 76b, which also extend from second surface 63 of top plate 61, are sized to sealingly engage outer surfaces 51a and 51b, respectively, of the associated cylindrical tubes 50a, 50b of cap 40. The result is that when closure 30 is in the closed position, there is no pathway for the substance disposed in container 20 to be dispensed from fluid dispensing bottle 10.
FIGS. 8 and 9 show section view of the first embodiment assembled closure 30. FIG. 8 is a section view of assembled closure 30 when closure 30 is in a first opened position. FIG. 9 is a section view of assembled closure 30 when closure 30 is in a second opened position. In each opened position, pivotable top component 60 has been pivoted about horizontal hinge axis 70. In the first opened position, the pivot is in the clockwise direction, while in the second opened position, the pivot is in the counterclockwise direction.
In FIG. 8 (the first opened position), cylindrical plug 72a, which is associated with first channel 84 and first dispensing opening 86, has been displaced so that cylindrical plug 72a is no longer sealingly engage with inner surface 52a of cylindrical tube 50a. Cylindrical sleeves 76a, 76b remain sealingly engage with outer surfaces 51a, 51b of cylindrical tubes 50a, 50b, respectively. Also, cylindrical plug 72b associated with second channel 94 and second dispensing opening 96, remains sealingly engage with inner surface 52b of cylindrical tube 50b. First annular void 82 is formed. The result is that when closure 30 is in the first opened position, first dispensing pathway 80 is created, and the substance disposed in container 20 passes through first channel 84 and is dispensed from fluid dispensing bottle 10 through first dispensing opening 86.
In FIG. 9 (the second opened position), cylindrical plug 72b, which is associated with second channel 94 and second dispensing opening 96, has been displaced so that cylindrical plug 72b is no longer sealingly engage with inner surface 52b of cylindrical tube 50b. Cylindrical sleeves 76a, 76b remain sealingly engage with outer surfaces 51a, 51b of cylindrical tubes 50a, 50b, respectively. Also, cylindrical plug 72a associated with first channel 84 and first dispensing opening 86, remains sealingly engage with inner surface 52a of cylindrical tube 50a. Second annular void 92 is formed. The result is that when closure 30 is in the second opened position, second dispensing pathway 90 is created, and the substance disposed in container 20 passes through second channel 94 and is dispensed from fluid dispensing bottle 10 through second dispensing opening 96.
As mentioned earlier second dispensing opening 96 and associated second channel 94 have larger cross sections, perpendicular to a flow direction, than first dispensing opening 86 and associated channel first channel 84. This allows for more substance to be dispensed from fluid dispensing bottle 10 when closure 30 is in the second opened position than when it is in the first opened position. If dispensing bottle 10 is a squeeze bottle, then a similar amount of manual pressure applied to container 20 yields more substance from fluid dispensing bottle 10 when closure 30 is in the second opened position than when it is in the first opened position.
In some embodiments, indicia may be disposed on first surface 62 of top plate 61 of pivotable top component 60 near first dispensing opening 86 and second dispensing opening 96 to indicate that more substance will disperse from fluid dispensing bottle 10 when closure 30 is in the second opened position than when it is in the first opened position.
FIGS. 10 and 11 show views of an assembled second closure embodiment. FIG. 10 is a section view of an assembled closure 130 in the closed position, while FIG. 11 is a section view of assembled closure 130 in a first opened position. As with the first embodiment, closure 130 has a cap 140 and a pivotable top component. Cap 140 has an outer surface 141, an inner surface 142, and a base plate 144.
Base plate 144 has a top surface 145 and a bottom surface 146, a cylindrical tube 150 extending from top surface 145 of base plate 144, protrusions 158a, 158b extending from outer surface 141 of base plate 144, a container sealing ring 156, and a snap fit 157. Aperture 153 is defined by cylindrical tube 150.
Sealing ring 156 and snap fit 157 extend from bottom surface 146 of base plate 144. Snap fit 157 attaches closure 130 to a container, and sealing ring 156 prevents leakage of the substance (e.g. liquid) disposed in the container. Although a snap fit is described here, screw threads or adhesives may also be used to attach closure 130 to a container, and the seal between closure 130 and the container may, in some embodiments, include a gasket.
Cylindrical tube 150, extending from top surface 145 of base plate 144 has an outer surface 151 and an inner surface 152. Cylindrical tube 150, as mentioned above, defines an aperture 153 through base plate 144. Aperture 153 is in fluid communication with the contents of the container.
The pivotable top component portion of cap 140 has a top plate 161, a pivotable top component rim 165, a pin 169, a first dispensing opening 186, a first channel 184 and a second channel 194. The pivotable top component also has a rocker arm and a second dispensing opening (not shown).
Top plate 161 has a first surface 162 and a second surface 163. Cylindrical plug 172 and cylindrical sleeve 176 extend from second surface 163 of top plate 161.
Pivotable top component rim 165 has a pair of notches 167a,b.
Although not shown on the figures, the second dispensing opening and associated second channel 194 have larger cross sections, perpendicular to a flow direction, than first dispensing opening 186 and associated channel first channel 184.
Also not shown in the figures is a horizontal hinge axis which provides the pivot axis for pivotable top component. In each opened position, the pivotable top component is pivoted about the horizontal hinge axis. In the first opened position, the pivot is in the clockwise direction, while in the second opened position, the pivot is in the counterclockwise direction.
FIG. 10 shows a section view of the second embodiment of assembled closure 130 in the closed position. The figure shows cylindrical plug 172, which extends from second surface 163 of top plate 161, are sized to sealingly engage inner surface 152 of cylindrical tube 150 of cap 140. Cylindrical sleeve 176, which also extend from second surface 163 of top plate 161, is sized to sealingly engage outer surface 151 of cylindrical tube 150 of cap 140. The result is that when closure 130 is in the closed position, there is no pathway for the substance disposed in the container to be dispensed from fluid dispensing bottle.
FIG. 11 shows a section view of the second embodiment assembled closure 130 when closure 130 is in a first opened position. In the opened position, to pivotable top component has been pivoted about horizontal hinge axis (not shown in the figure). In the first opened position, the pivot is in the clockwise direction. In a second opened position, the pivot would be in the counterclockwise direction.
In FIG. 11, cylindrical plug 172, which is associated with first channel 184 and first dispensing opening 186, has been displaced so that cylindrical plug 172 is no longer sealingly engage with inner surface 152 of cylindrical tube 150. Cylindrical sleeve 176 remain sealingly engage with outer surface 151 of cylindrical tube 150. First annular void 182 is formed. The result is that when closure 130 is in the first opened position, a first dispensing pathway is created, and the substance disposed in the container passes through first channel 184 and is dispensed from the fluid dispensing bottle through first dispensing opening 186.
Though not shown, second embodiment assembled closure 130 may be pivoted in the counterclockwise direction to a second opened position, forming a second annular void, a second dispensing pathway, and the substance disposed in the container would pass through second channel 194 and be dispensed from the fluid dispensing bottle through a second dispensing opening.
The present invention will be further understood by reference to the following specific Examples which are illustrative of the composition, form and method of producing the present invention. It is to be understood that many variations of composition, form and method of producing this would be apparent to those skilled in the art. The following Examples, wherein parts and percentages are by weight unless otherwise indicated, are only illustrative.
EXAMPLES
Example 1: Formation and Assembly of Fluid Dispensing Bottle
Containers with openings sized to fit closures of the present invention were formed by blow molding. The containers were made of High-Density Polyethylene (HDPE). The capacity of the molded containers was 200 mL.
First embodiment container closures of the present invention were made by injection molding. Caps and pivotable top components were molded separately out of Polypropylene (PP), and then manually assembled to form container closures. The first dispensing openings had rectangular cross-sections which were 2 mm by 4 mm. The second dispensing openings had rectangular cross-sections which were 2 mm by 6 mm. Containers and closures were manually assembled to form fluid dispensing bottles.
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17002840
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johnson & johnson consumer inc.
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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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|
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Apr 5th, 2022 05:11PM
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Apr 5th, 2022 05:11PM
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Johnson & Johnson
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Health Care
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Pharmaceuticals & Biotechnology
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