CA2549191A1 - Improved ocular lens - Google Patents

Improved ocular lens Download PDF

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Publication number
CA2549191A1
CA2549191A1 CA002549191A CA2549191A CA2549191A1 CA 2549191 A1 CA2549191 A1 CA 2549191A1 CA 002549191 A CA002549191 A CA 002549191A CA 2549191 A CA2549191 A CA 2549191A CA 2549191 A1 CA2549191 A1 CA 2549191A1
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CA
Canada
Prior art keywords
lens device
ocular lens
polyisobutylene
ocular
copolymer
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002549191A
Other languages
French (fr)
Other versions
CA2549191C (en
Inventor
Leonard Pinchuk
Jean-Marie Parel
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Innolene LLC
Original Assignee
Innfocus, Llc
Leonard Pinchuk
Jean-Marie Parel
Innolene Llc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Innfocus, Llc, Leonard Pinchuk, Jean-Marie Parel, Innolene Llc filed Critical Innfocus, Llc
Publication of CA2549191A1 publication Critical patent/CA2549191A1/en
Application granted granted Critical
Publication of CA2549191C publication Critical patent/CA2549191C/en
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A61L27/16—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16—Intraocular lenses
    • A61F2/1613—Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16—Intraocular lenses
    • A61F2/1613—Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus
    • A61F2/1624—Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus having adjustable focus; power activated variable focus means, e.g. mechanically or electrically by the ciliary muscle or from the outside
    • A61F2/1629—Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus having adjustable focus; power activated variable focus means, e.g. mechanically or electrically by the ciliary muscle or from the outside for changing longitudinal position, i.e. along the visual axis when implanted
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/54—Biologically active materials, e.g. therapeutic substances
    • G—PHYSICS
    • G02—OPTICS
    • G02B—OPTICAL ELEMENTS, SYSTEMS OR APPARATUS
    • G02B1/00—Optical elements characterised by the material of which they are made; Optical coatings for optical elements
    • G02B1/04—Optical elements characterised by the material of which they are made; Optical coatings for optical elements made of organic materials, e.g. plastics
    • G02B1/041—Lenses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16—Intraocular lenses
    • A61F2/1613—Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus
    • A61F2/1648—Multipart lenses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16—Intraocular lenses
    • A61F2002/1681—Intraocular lenses having supporting structure for lens, e.g. haptics
    • A61F2002/169—Surrounding optic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/0008—Introducing ophthalmic products into the ocular cavity or retaining products therein
    • A61F9/0017—Introducing ophthalmic products into the ocular cavity or retaining products therein implantable in, or in contact with, the eye, e.g. ocular inserts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/416—Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/16—Materials or treatment for tissue regeneration for reconstruction of eye parts, e.g. intraocular lens, cornea

Abstract

An ocular lens (32) has a refractive optics structure formed from a polyisobutylene-based material and a glassy segment that is non-reactive to ocular fluid and that maintains in vivo transparency for a substantial time period. The material has a central elastomeric polyolefinic block and thermoplastic end blocks (such as a triblock polymer backbone comprising polystyrene-polyisobutylene-polystyrene). The material is preferably flexible such that the refractive optics structure can be folded upon itself and introduced through a small scleral incision. The lens device includes an optic portion and preferably either an annular haptic element or one or more haptic elements adapted to rest within a capsular bag formed by a surgical procedure.
A portion of the lens device may be loaded with at least one therapeutic agent that interferes with proliferation of the epithelial cells of the eye to protect against PCO.

Claims (54)

1. An ocular lens device comprising:

a refractive optics structure formed from a copolymer of a non-cross-linked polyisobutylene-based material with a glassy segment, the copolymer being non-reactive in an ocular environment, wherein the copolymer is formulated to maintain in vivo transparency for at least two months.
2. An ocular lens device according to claim 1, wherein:

said copolymer is flexible such that said refractive optics structure can be folded or rolled upon itself.
3. An ocular lens device according to claim 2, wherein:

said ocular lens device is foldable such that it can be introduced through a small scleral incision.
4. An ocular lens device according to claim 3, wherein:

said small sclera incision comprises a slit having a length of 2 mm or less.
5. An ocular lens device according to claim 1, wherein:

said glassy segment does not contain any cleavable group which will release in the presence of ocular fluid.
6. An ocular lens device according to claim 1, wherein:
said glassy segment comprises a vinyl aromatic polymer.
7. An ocular lens device according to claim 5, wherein:
said vinyl aromatic polymer comprises at least one of polystyrene, and .alpha.-methylstyrene.
8. An ocular lens device according to claim 1, wherein:
said glassy segment comprises a methacrylate polymer.
9. An ocular lens device according to claim 8, wherein:
said methactylate polymer comprises at least one of methylmethacrylate, ethylmethacrylate, and hydroxymethalcrylate.
10. An ocular lens device according to claim 1, wherein:
said non-cross-linked polyisobutylene-based material has a general block structure with a central elastomeric polyolefinic block and thermoplastic end blocks.
11. An ocular lens device according to claim 10, wherein:
said non-cross-linked polyisobutylene-based material comprises a triblock polymer backbone comprising polystyrene-polyisobutylene-polystyrene.
12. An ocular lens device according to claim 10, wherein:

said non-cross-linked polyisobutylene-based material has a general block structure selected from one of the following:

a) BAB or ABA, b) B(AB)o or A(BA)n, and c) X-(AB)n or X-(BA)n;

where A is an elastomeric polyolefinic block, B is a thermoplastic block, n is a positive whole number and X is a starting seed molecule.
13. An ocular lens device according to claim 12, wherein:

said non-cross-linked polyisobutylene-based material comprises one of a star-shaped block copolymer (where n=3 or more) and multi-dendrite-shaped block copolymer.
14. An ocular lens device according to claim 1, further comprising:

an optic portion and at least one haptic element that are adapted to rest within a capsular bag formed by a surgical procedure, wherein said at least one haptic element supports said optic portion.
15. An ocular lens device according to claim 14, wherein:

said at least one haptic element comprises a plurality of haptic elements that project radially away from said optic portion.
16. An ocular lens device according to claim 14, wherein:

said at least one haptic element comprises an annular surface that extends radially outward from said optic portion.
17. An ocular lens device according to claim 16, wherein:

said optic region is substantially disposed along a plane that is perpendicular to the optical axis of the eye, and said annular surface projects radially outward from said optic portion at an angle relative to said plane, said angle between 0 and 45 degrees.
18. An ocular lens device according to claim 17, wherein:

said angle is between 10 and 20 degrees.
19. An ocular lens device according to claim 18, wherein:

said angle is 15 degrees.
20. An ocular lens device according to claim 14, wherein:

said optic portion has a front convex surface and a flat back surface.
21. An ocular lens device according to claim 14, wherein:

said optic portion has a stepped wall structure at its periphery.
22. An ocular lens device according to claim 14; wherein:

said optic portion and said at least one haptic element are formed from said material.
23. An ocular lens device according to claim 14, wherein:

said optic portion is formed from said material, and said at least one haptic element is formed from a different material.
24. An ocular lens device according to claim 1, wherein:

said non-cross-linked polyisobutylene-based material blocks ultra-violet light.
25. An ocular lens device according to claim 1, wherein:

said copolymer is loaded with at least one therapeutic agent that interferes with proliferation of the epithelial cells of the eye.
26. An ocular lens device according to claim 25, wherein:

said at least one therapeutic agent is selected from the group of cytostatic agents and anti-migratory agents.
27. An ocular lens device according to claim 25, wherein:

said at least one therapeutic agent comprises paclitaxel or an analog of paclitaxel.
28. An ocular lens device according to claim 1, wherein:

said refractive optics structure is adapted for intraocular disposition in one of the anterior chamber of the eye, the posterior chamber of the eye , and the vitreous chamber of the eye.
29. An ocular lens device according to claim 1, wherein:

said non-cross-linked polyisobutylene-based material is formed by a polyisobutylene-based polymer with substantially all remnant salts washed from the polyisobutylene-based polymer.
30. An ocular lens device according to claim 29, wherein:

the refractive optics structure is formed and molded at temperatures that are significantly less that the melting point of the polyisobutylene-based polymer.
31. An ocular lens device according to claim 29, wherein:

the refractive optics structure is formed by compression molding in conjunction with rapid heating to a temperature at or near the melting point of the polyisobutylene-based polymer and rapid cooling.
32. An ocular lens device according to claim 31, wherein:

time duration encompassing the rapid hearing and the rapid cooling defines a heating-cooling cycle that is less than three minutes.
33 33. An ocular lens device according to claim 32, wherein:

said heat-cooling cycle is less than one minute.
34. An ocular lens device according to claim 30, wherein:

said non-cross-linked polyisobutylene-based material is formed by dissolving said polyisobutylene-based polymer in a solvent to form a solution and casting the solution.
35. An ocular lens device according to claim 34, wherein:

the casting of the solution forms at least one lens preform, and said refractive optics structure is formed by compression molding of said at least one lens preform.
36. An ocular lens device comprising:

a refractive optics structure formed from a copolymer of a non-cross-linked polyisobutylene-based material with a glassy segment, the copolymer being non-reactive in an ocular environment, said non-cross-linked polyisobutylene-based material derived from a polyisobutylene-based polymer that is washed to substantially remove remnant salts from the polyisobutylene-based polymer.
37. An ocular lens device according to claim 36, wherein:

the refractive optics structure is formed and molded at temperatures that are significantly less that the melting point of the polyisobutylene-based polymer.
38. An ocular lens device according to claim 36, wherein:

the refractive optics structure is formed by compression molding in conjunction with rapid heating to a temperature at or near the melting point of the polyisobutylene-based polymer and rapid cooling.
39. An ocular lens device according to claim 38, wherein:

time duration encompassing the rapid heating and the rapid cooling defines a heating-cooling cycle that is less than three minutes.
40. An ocular lens device according to claim 39, wherein:

said heat-cooling cycle is less than one minute.
41. An ocular lens device according to claim 37, wherein:

said non-cross-linked polyisobutylene-based material is formed by dissolving the washed polyisobutylene-based polymer in a solvent to form a solution and casting the solution.
42. An ocular lens device comprising:

a refractive optics structure formed from a copolymer of a non-cross-linked polyisoburylene-based material with a glassy segment, the copolymer being non-reactive in an ocular environment and being flexible such that said refractive optics structure can be folded or rolled upon itself.
43. An ocular lens device according to claim 42, wherein:

said ocular lens device is foldable such that it can be introduced through a small scleral incision.
44. An ocular lens device according to claim 43, wherein:

said small sclera incision comprises a slit having a length of 2 mm or less.
45. An ocular lens device comprising:

a structure formed from a copolymer of a non-cross-linked polyisobutylene-based material with a glassy segment, the copolymer being non-reactive in an ocular environment, wherein said copolymer is loaded with at least one therapeutic agent that interferes with proliferation of the epithelial cells of the eye.
46. An ocular lens device according to claim 45, wherein:

said at least one therapeutic agent is selected from the groups of cytostatic agents and anti-migratory agents.
47. An ocular lens device according to claim 45, wherein:

said at least one therapeutic agent comprises paclitaxel or an analog of paclitaxel.
48. A surgical method comprising:

providing an intraocular lens device including a refractive optics structure formed from a copolymer of a non-cross-linked polyisobutylene-based material and a glassy segment, the copolymer being non-reactive in the intended ocular environment of the device and being-formulated to maintain in vivo transparency for at least two months, and wherein said intraocular lens device is flexible such that it can be folded or rolled upon itself;

folding or rolling said intraocular lens device upon itself and inserting the folded or rolled intraocular lens device through a scleral incision; and unfolding or unrolling said intraocular lens device and positioning said intraocular lens device such that it is supported within a capsulary bag.
49. The surgical method of claim 48, wherein:

the size of the scleral incision is small.
50. The surgical method of claim 49, wherein:

the sclera incision comprises a slit having a length of 2 mm or less.
51. The surgical method of claim 48, further comprising:

forming the scleral incision;

inserting tooling through the scleral incision and manipulating the tooling to tear the anterior capsule wall of the human eye to form a capsulary bag defined by a remaining portion of the anterior capsule wall and the posterior capsule wall of the human eye;
and removing at least a portion of the natural crystalline lens of the human eye through the scleral incision;
52. The surgical method of claim 48, wherein:

a portion of said intraocular lens device is loaded with at least one therapeutic agent that interferes with proliferation of the epithelial cells of the eye.
53. The surgical method of claim 52, wherein:

said at least one therapeutic agent is selected from the groups of cytostatic agents and anti-migratory agents.
54. The surgical method of claim 53, wherein:

said at least one therapeutic agent comprises paclitaxel or an analog of paclitaxel.
CA2549191A 2003-12-05 2004-12-03 Improved ocular lens Expired - Fee Related CA2549191C (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US52696503P 2003-12-05 2003-12-05
US52696603P 2003-12-05 2003-12-05
US60/526,966 2003-12-05
US60/526,965 2003-12-05
PCT/US2004/040447 WO2005057272A2 (en) 2003-12-05 2004-12-03 Improved ocular lens

Publications (2)

Publication Number Publication Date
CA2549191A1 true CA2549191A1 (en) 2005-06-23
CA2549191C CA2549191C (en) 2012-10-23

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
CA2549191A Expired - Fee Related CA2549191C (en) 2003-12-05 2004-12-03 Improved ocular lens

Country Status (6)

Country Link
US (3) US7794498B2 (en)
EP (1) EP1696831B1 (en)
JP (1) JP5009623B2 (en)
AU (1) AU2004297967C1 (en)
CA (1) CA2549191C (en)
WO (1) WO2005057272A2 (en)

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