APPARATUS, METHODS AND DEVICES FOR TREATMENT OF OCULAR DISORDERS

• US 20100241046A1
• Filed: 09/06/2007
• Published: 09/23/2010
• Est. Priority Date: 09/06/2006
• Status: Abandoned Application

• Current Assignee: Innfocus, LLC
• Original Assignee: Innfocus, LLC
• Inventors: Fantes, Francisco, Parel, Jean-Marie A., Pinchuk, Leonard
• Application Number:
  US12/440,096
• Publication Number:
  US 20100241046A1
• Time in Patent Office: Days
• US Class Current: 604/8
• CPC Class Codes: A61F 2250/0024 made from both porous and non-porous parts, e.g. adjacent parts
• CPC Class Codes: A61F 9/00781 Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment drainage implants in general A61M27/002
• CPC Class Codes: A61L 27/48 with macromolecular fillers
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/129 containing macromolecular fillers
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: C08L 53/02 of vinyl-aromatic monomers and conjugated dienes

Abstract

Apparatus and methods for relieving and treating glaucoma and other ocular disorders are disclosed. The apparatus includes a thin flexible membrane and preferably a tubular member. In another aspect of the invention, a surgical device for repairing ocular tissue includes a flexible membrane of a polymeric material comprising polyisobutylene. In the preferred embodiment, the polymeric material of the membrane is porous.

Claims

1. An apparatus for relieving pressure in an eye, comprising:

a) a tubular member having a first end opposite a second end, the first end operatively inserted into the anterior chamber of the eye, the tubular member defining a lumen providing a flowpath for drainage of aqueous humor from the anterior chamber of the eye; and

b) a flexible polymeric membrane operably disposed adjacent the second end of the tubular member outside the lumen of the tubular member, said membrane having a thickness between 0.04 mm and 0.5 mm and sized to enable growth of tissue around said membrane to form a bleb which acts as a reservoir for drainage of aqueous humor into the ocular environment.

2. The apparatus of claim 1, wherein:

said membrane is porous and allows for aqueous humor to flow therethrough.

3. The apparatus of claim 1, wherein:

said membrane is microporous.

4. The apparatus of claim 1, wherein:

said membrane is non-porous and does not allow for aqueous humor to flow therethrough.

5. The apparatus of claim 1, wherein:

at least one of said membrane and said tubular member includes polyisobutylene.

6. The apparatus of claim 1, wherein:

said membrane has a Shore hardness between 20 A and 90 A.

7. The apparatus of claim 1, wherein:

said tubular member and said membrane are integrated as a unitary piece.

8. The apparatus of claim 7, wherein:

the tubular member and membrane are integrated together by one of insert molding, suturing, melting, and solvent bonding.

9. The apparatus of claim 1, wherein:

at least one of said tubular member and said membrane is loaded with one or more drugs.

10. The apparatus of claim 9, wherein:

said one or more drugs includes one of an antiproliferative, a fibrotic agent, a anticoagulant, and a blocking agent.

12. The apparatus of claim 1, wherein:

said tubular member includes a fixation member.

13. The apparatus of claim 1, wherein:

said membrane includes a stepped interface from a smaller thickness to a larger thickness, and the second end of said tubular member is operably disposed adjacent said stepped interface.

14. The apparatus of claim 13, wherein:

the larger thickness of said stepped interface prevents the membrane from inadvertently folding.

15. The apparatus of claim 1, wherein:

said membrane covers a surface area in a range between 50 mm2 and 150 mm2.

11. (canceled)

16. A method for relieving intraocular pressure in an ocular environment, said method comprising the steps of:

a) providing a tubular member and a flexible polymeric membrane, said tubular member having a first end opposite a second end, and said membrane having a thickness between 0.04 mm and 0.5 mm;

b) inserting the first end of said tubular member into an anterior chamber of the eye, the tubular member defining a lumen providing a flowpath for drainage of aqueous humor from the anterior chamber of the eye; and

c) inserting said membrane into the ocular environment whereby the membrane is positioned adjacent the second end of the tubular member outside the lumen of the tubular member and is sized to enable growth of tissue around said membrane to form a bleb which acts as a reservoir for drainage of aqueous humor into the ocular environment.

17. The method of claim 16, wherein:

said membrane is porous and allows for aqueous humor to flow therethrough.

18. The method of claim 16, wherein:

said flexible membrane is microporous.

19. The method of claim 16, wherein:

said membrane is non-porous and does not allow for aqueous humor to flow therethrough.

20. The method of claim 16, wherein:

at least one of said membrane and said tubular member includes polyisobutylene.

21. The method of claim 16, wherein:

said membrane has a Shore hardness between 20 A and 90 A.

22. The method of claim 16, wherein:

said tubular member and said membrane are integrated together as a unitary piece.

23. The method of claim 22, wherein:

said tubular member and said membrane are integrated together by one of insert molding, suturing, melting, and solvent bonding.

24. The method of claim 16, wherein:

at least one of said tubular member and said membrane is loaded with one or more drugs.

25. The method of claim 24, wherein:

said one or more drugs includes one of an antiproliferative, a fibrotic agent, an anticoagulant, and a blocking agent.

27. The method of claim 16, wherein:

said tubular member includes a fixation member.

28. The method of claim 16, wherein:

said membrane includes a stepped interface from a smaller thickness to a larger thickness, and the second end of said tubular member is operably disposed adjacent said stepped interface.

29. The method of claim 28, wherein:

the larger thickness of said stepped interface prevents the membrane from inadvertently folding.

30. The method of claim 16, wherein:

said membrane covers a surface area in a range between 50 mm2 and 150 mm2.

31. The method of claim 16, wherein:

said membrane is positioned under the conjunctiva of the eye.

32. The method of claim 31, wherein:

said membrane is positioned into a flap in the eye formed between the conjunctiva/Tenon'"'"'s connective tissues and the sclera.

26. (canceled)

33. An apparatus for treating a disorder of the eye, comprising:

a flexible membrane realized from a block copolymer including polyisobutylene, wherein said flexible membrane has a thickness between 0.04 mm and 0.5 mm.

34. The apparatus of claim 33, wherein:

one or more drugs are loaded into said block copolymer.

35. The apparatus of claim 34, wherein:

said one or more drugs treats macular degeneration.

36. The apparatus of claim 34, wherein:

said one or more drugs treats glaucoma.

37. The apparatus of claim 34, wherein:

said one or more drugs includes one of an antiproliferative, a fibrotic agent, an anticoagulant, and a blocking agent.

38. The apparatus of claim 34, wherein:

said flexible membrane has a Shore hardness between 20 A and 90 A.

39. The apparatus of claim 34, wherein:

said flexible membrane is porous.

40. The apparatus of claim 34, wherein:

said flexible membrane is microporous.

41. The apparatus of claim 34, wherein:

said flexible membrane is non-porous.

42. An apparatus for relieving pressure in an eye, comprising:

a) a tubular member having a first end opposite a second end, the first end operatively inserted into the anterior chamber of the eye, the tubular member defining a lumen providing a flowpath for drainage of aqueous humor from the anterior chamber of the eye; and

b) a flexible polymeric membrane operably disposed adjacent the second end of the tubular member outside the lumen of the tubular member and sized to enable growth of tissue around said membrane to form a bleb which acts as a reservoir for drainage of aqueous humor into the ocular environment;

wherein said membrane has a thickness between 0.04 mm and 0.5 mm and has a Shore hardness between 20 A and 90 A, and wherein at least one of said membrane and said tubular member includes polyisobutylene.

43. A surgical device for repairing ocular tissue comprising:

a flexible membrane of a polymeric material comprising polyisobutylene.

44. The surgical device of claim 43, wherein:

said polymeric material is porous.

45. The surgical device of claim 43, wherein:

said flexible membrane has a thickness between 0.04 mm and 0.5 mm.

46. The surgical device of claim 43, wherein:

said flexible membrane has a Shore hardness between 20 A and 90 A.