OPHTHALMIC IMPLANT FOR TREATMENT OF GLAUCOMA

• US 20120010702A1
• Filed: 09/15/2011
• Published: 01/12/2012
• Est. Priority Date: 12/16/2004
• Status: Abandoned Application

• Current Assignee: Nova Eye Incorporated
• Original Assignee: iScience Interventional Corporation
• Inventors: McKENZIE, John, STEGMANN, Robert, CONSTON, Stanley R., KUPIECKI, David J., PINSON, Candice D., YAMAMOTO, Ronald K.
• Application Number:
  US13/233,986
• Publication Number:
  US 20120010702A1
• Time in Patent Office: Days
• US Class Current: 623/4.1
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 9/0008 Introducing ophthalmic products into the ocular cavity or retaining products therein putting in contact lenses A61F9/0061; introducing or retaining media in cavities of the body in general A61M31/00
• 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: A61M 27/002 Implant devices for drainage of body fluids from one part of the body to another intraocular A61F9/00781; middle ear A61F11/202

Abstract

An implant is placed within Schlemm'"'"'s canal of the eye and provides tension to the trabecular meshwork. The tension is continuous and increases the aqueous outflow without the necessity of administering cholinergic drugs to treat glaucoma.

Claims

1. An implant for the treatment of glaucoma comprising an elongated element with distal and proximal ends positionable within Schlemm'"'"'s canal of the eye so as to provide a tensioning force to the inner wall of the canal to thereby increase fluid permeability of the inner wall of the canal.

2. An implant according to claim 1 wherein said tensioning force is provided to said implant through a securing element at said one or both of said ends, said securing element attachable to a tensioning element providing said tensioning force.

3. An implant according to claim 2 wherein said tensioning element comprises a spring.

4. An implant according to claim 2 wherein said tensioning element is accommodated in a protecting housing.

5. An implant according to claim 2 wherein said tensioning element comprises a crimping element for securing said implant in a tensioned position.

6. An implant according to claim 1 wherein said implant is provided with sufficient mechanical stiffness to impart said tensioning force to said inner wall upon placement within said canal.

7. An implant according to claim 1 wherein said elongated element comprises a helical filament.

8. An implant according to claim 1 comprising at least two of said elongated elements twisted together in a helical manner.

9. An implant according to claim 1 comprising at least two of said elongated elements fixed in a parallel manner.

10. An implant according to claim 1 wherein said elongated element comprises a serpentine filament having a circular cross-sectional aspect.

11. An implant according to claim 1 wherein said elongated element comprises a serpentine filament having an ovoid cross-sectional aspect.

12. An implant according to claim 10 or 11 wherein said filament comprises a series of loops.

13. An implant according to claim 1 wherein said elongated element comprises first regions of a first cross-sectional dimension interspaced with second regions of a second cross-sectional dimension wherein said first cross-sectional dimension is larger than said second cross-sectional dimension.

14. An implant according to claim 13 wherein said first regions comprise beads.

15. An implant according to claim 13 wherein said first regions comprise cylindrical segments.

16. An implant according to claim 13 wherein said first regions freely rotate relative to said second regions.

17. An implant according to claim 1 wherein said elongated element comprises filament loops connected to an axial element.

18. An implant according to claim 1 wherein said elongated element comprises filament loops connected at alternating ends.

19. An implant according to claim 1 wherein said elongated element is provided with a shape to promote flow of aqueous humor from the inner wall of said canal to the collector channels on the outer wall of said canal.

20. An implant according to claim 19 wherein said shape comprises multiple angular bends resembling a saw-tooth profile.

21. An implant according to claim 19 wherein said shape comprises repeating semicircular profiles.

22. An implant according to claim 19 wherein said shape comprises a helical filament.

23. An implant according to claim 19 wherein said shape comprises a tube with internal channels.

24. An implant according to claim 2 wherein said securing element comprises a ring.

25. An implant according to claim 2 wherein said tensioning element comprises a spring.

26. An implant according to claim 2 wherein said tensioning element comprises an elastic element providing 4 to 6 grams force per mm change in length.

27. An implant according to claim 2 wherein said securing element comprises a clamp.

28. An implant according to claim 2 wherein said securing element allows adjustment of the length of said implant.

29. An implant according to claim 1 provided with an expanded tip to dilate said canal.

30. An implant according to claim 1 comprising a metal.

31. An implant according to claim 1 comprising a biocompatible polymer.

32. An implant according to claim 1 comprising a biologically active agent.

33. An implant according to claim 32 wherein said biologically active agent is selected from the group consisting of an anti-thrombogenic agent, anti-microbial agent, anti-inflammatory agent, anti-fibrotic agent, anti-cell proliferative agent and anti-adhesion agent.

34. An implant according to claim 33 wherein said biologically active agent is selected from the group consisting of heparin, tissue plasminogen activator, a steroid, an antimicrobial agent, hyaluronic acid, rapamycin, paclitaxol, 5-fluorouracil, mitomycin and methotrexate.

35. An implant according to claim 1 wherein said tensioning force is in the range of about 0.027 to 0.292 grams force per mm arc length of said canal.

36. An implant according to claim 35 wherein said tensioning force is in the range of about 0.159 to 0.265 grams force per mm arc length of said canal.

37. An implant according to claim 1 or 2 wherein said ends are connected with a tensioning force in the range of about 1 to 11 grams.

38. An implant according to claim 37 wherein said ends are connected with a tensioning force in the range of about 6 to 10 grams.

49. An implant according to any one of claims 1 to 11 wherein said tensioning force is axial.

50. An implant according to any one of claims 13 to 36 wherein said tensioning force is axial.

51. An implant according to claim 37 wherein said tensioning force is axial.

52. An implant according to claim 38 wherein said tensioning force is axial.

39. A tool for insertion of an implant into Schlemm'"'"'s canal of the eye comprising an implant comprising an elongated element with distal and proximal ends positionable within said canal so as to provide a tensioning force to the inner wall of said canal to thereby increase fluid permeability of the inner wall of said canal, said implant attached to a flexible cannula.

41. A tool according to claim 39 further comprising a mechanical element on said cannula for attachment of said implant to said cannula.

42. A tool according to claim 41 wherein said mechanical element comprises a hole, slot, or an area of increased diameter at a tip of said cannula.

43. A tool according to claim 39 or 40 further comprising a guidance element for locating said tool during placement and advancement within Schlemm'"'"'s canal.

44. A tool according to claim 43 wherein said guidance element comprises a fiber optic beacon.

45. A tool according to claim 39 further comprising an expandable mechanical element for dilating said canal.

46. A tool according to claim 39 further comprising a lumen for injection of viscous materials.

47. A tool according to claim 39 further comprising a lubricious coating.

48. A tool according to claim 39 wherein said cannula comprises a rounded tip.

53. A tool according to claim 39 or 40 wherein said tensioning force is axial.

40. A tool for insertion of an implant into Schlemm'"'"'s canal of the eye comprising an implant comprising an elongated element with distal and proximal ends positionable within said canal so as to provide a tensioning force to the inner wall of said canal to thereby increase fluid permeability of the inner wall of said canal, said implant attached to a guidewire.