Ocular lens

• US 20050125059A1
• Filed: 12/03/2004
• Published: 06/09/2005
• Est. Priority Date: 12/05/2003
• Status: Active Grant

• Current Assignee: Eyedeal Hongkong Limited
• Original Assignee: Innolene LLC
• Inventors: Pinchuk, Leonard, Parel, Jean-Marie
• Granted Patent: US 7,794,498 B2
• Time in Patent Office: Days
• US Class Current: 623/6.560
• CPC Class Codes: A61F 2/1613 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
• CPC Class Codes: A61F 2/1629 for changing longitudinal position, i.e. along the visual axis when implanted
• CPC Class Codes: A61F 2/1648 Multipart lenses
• CPC Class Codes: A61F 2002/169 Surrounding optic
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 2430/16 for reconstruction of eye parts, e.g. intraocular lens, cornea
• CPC Class Codes: A61L 27/16 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: C08L 23/22 Copolymers of isobutene; Butyl rubber ; Homo- or copolymers of other iso-olefins
• CPC Class Codes: C08L 25/08 Copolymers of styrene C08L29/08, C08L35/06, C08L55/02 take precedence
• CPC Class Codes: C08L 53/02 of vinyl-aromatic monomers and conjugated dienes
• CPC Class Codes: G02B 1/041 Lenses

Abstract

An ocular lens 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

1. An ocular lens device comprising:

a refractive optics structure formed from a polyisobutylene-based material with a glassy segment that is non-reactive in an ocular environment, wherein the refractive optics structure is formulated to maintain in vivo transparency for at least two months.

2. An ocular lens device according to claim 1, wherein:

said material 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 α

-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 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 material comprises a triblock polymer backbone comprising polystyrene-polyisobutylene-polystyrene.

12. An ocular lens device according to claim 10, wherein:

said material has a general block structure selected from one of the following;

a) BAB or ABA,

b) B(AB)_n 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 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 material blocks ultra-violet light.

25. An ocular lens device according to claim 1, wherein:

said material 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 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 heating and the rapid cooling defines a heating-cooling cycle that is less than three minutes.

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 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 polyisobutylene-based material with a glassy segment that is non-reactive in an ocular environment, said 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 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 polyisobutylene-based material with a glassy segment that is non-reactive in an ocular environment, wherein said material is 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 polyisobutylene-based material with a glassy segment that is non-reactive in an ocular environment, wherein said material 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 polyisobutylene-based material and a glassy segment that is non-reactive in the intended ocular environment of the device, wherein said refractive optics structure is 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