Shunt device and method for treating glaucoma

• US 7,850,637 B2
• Filed: 11/12/2004
• Issued: 12/14/2010
• Est. Priority Date: 04/26/1999
• Status: Expired due to Fees

• Current Assignee: Glaukos Corporation
• Original Assignee: Glaukos Corporation
• Inventors: Brown, Reay H., Lynch, Mary G.
• Primary Examiner(s): Zalukaeva; Tatyana
• Assistant Examiner(s): Chapman; Ginger T
• Application Number:
  US10/987,114
• Publication Number:
  US 20050090806A1
• Time in Patent Office: 2,223 Days
• Field of Search: 604/8, 604/9, 604/10, 604/264, 604/284, 604/523, 604/521, 604/289, 604/107, 604/108, 623/4.1, 623/1.11, 623/1.35
• US Class Current: 604/8
• CPC Class Codes: A61F 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2230/0052 T-shaped
• 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: A61F 9/00781 Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment drainage implants in general A61M27/002
• CPC Class Codes: A61M 2210/0612 Eyes
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable

Abstract

Shunt devices and a method for continuously decompressing elevated intraocular pressure in eyes affected by glaucoma by diverting excess aqueous humor from the anterior chamber of the eye into Schlemm'"'"'s canal where post-operative patency can be maintained with an indwelling shunt device which surgically connects the canal with the anterior chamber. The shunt devices provide uni- or bi-directional flow of aqueous humor into Schlemm'"'"'s canal.

Claims

1. An implant for treating glaucoma, comprising:

a body being biocompatible when implanted, said body comprising;

a flow passage of sufficient length to extend from an anterior chamber of an eye into a physiologic outflow path of the eye;

an inlet section sized and shaped to be disposed in the anterior chamber; and

an outlet section shaped to be disposed in the physiologic outflow path and having a cross-sectional dimension within the range of about 0.1 mm to about 0.5 mm so as to fit within the physiologic outflow path, and having a plurality of outlets to drain into the physiologic outflow path.

2. The implant of claim 1, wherein the body is configured such that, when the implant is positioned within the eye, fluid flows from the anterior chamber through at least one inlet of the inlet section and into the outlets.

3. The implant of claim 1, wherein the body further comprises an anchor portion for stabilizing the body relative to the physiologic outflow path.

4. The implant of claim 3, wherein at least one of the outlets is disposed on the anchor portion.

5. The implant of claim 1, wherein the body further comprises a terminal aspect angulated to extend away from the iris.

6. The implant of claim 1, wherein at least a portion of the implant is comprised of a solid material.

7. The implant of claim 1, wherein at least a portion of the implant comprises a mesh material.

8. The implant of claim 1, wherein at least a portion of the implant is fenestrated.

9. The implant of claim 1, wherein the implant generally has a T-shape.

10. The implant of claim 1, wherein the outlet section is configured to be disposed within Schlemm'"'"'s canal.

11. The implant of claim 1, wherein the length of the portion of the body extending from the anterior chamber to the physiologic outflow path is about 2.0 mm.

12. The implant of claim 1, wherein the body further comprises an intermediate section between the inlet and outlet sections of sufficient length to extend through tissue between the anterior chamber and the physiologic outflow path.

13. The implant of claim 12, wherein the inlet, intermediate and outlet sections comprise a substantially continuous tubular structure.

14. The implant of claim 12, wherein the inlet and intermediate sections have a combined length within the range of about 0.1 mm to about 3 mm.

15. The implant of claim 14, wherein the combined length of the inlet and intermediate sections is about 2 mm.

16. The implant of claim 1, wherein the inlet and outlet sections comprise a substantially continuous tubular structure.

17. The implant of claim 1, wherein the body has a multi-angular configuration.

18. The implant of claim 1, wherein the cross-sectional dimension of the outlet section is about 0.3 mm.

19. The implant of claim 1, wherein the outlet section has a length within the range of about 1 mm to about 40 mm.

20. The implant of claim 19, wherein the length of the outlet section is about 6 mm.

21. The implant of claim 1, wherein the outlet section has a pre-formed curve with a radius of about 6 mm.

22. The implant of claim 1, wherein the flow passage comprises a channel.

23. The implant of claim 22, wherein the channel comprises a lumen.

24. The implant of claim 23, wherein at least a portion of the lumen has a diameter or width within the range of about 0.1 mm to about 0.5 mm.

25. The implant of claim 24, wherein at least a portion of the lumen has a diameter or width of about 0.2 mm.

26. An implant for treating glaucoma, comprising:

a body being biocompatible when implanted, said body comprising;

an inlet section sized and shaped to be disposed in an anterior chamber of an eye, the inlet section having at least one inlet;

an outlet section shaped to be disposed in a physiologic outflow path of the eye and having a cross-sectional dimension within the range of about 0.1 mm to about 0.5 mm so as to fit within the physiologic outflow path, and having a plurality of outlets to be disposed in the physiologic outflow path; and

a flow passage extending through the body from the inlet to the plurality of outlets.

27. The implant of claim 26 , wherein the body further comprises an anchor portion for stabilizing the body relative to the physiologic outflow path.

28. The implant of claim 27, wherein at least one of the outlets is disposed on the anchor portion.

29. The implant of claim 26, wherein the outlet section is configured to be disposed within Schlemm'"'"'s canal.

30. The implant of claim 29, wherein the flow passage diverges into at least two branches within the outlet section.

31. The implant of claim 30, wherein each of the at least two branches within the outlet section extend outward from a section of the flow passage in a direction substantially perpendicular to the section of the flow passage.

32. The implant of claim 31, wherein the at least two branches extend in opposite directions.

33. The implant of claim 26, wherein the body further comprises an intermediate section between the inlet and outlet sections of sufficient length to extend through tissue between the anterior chamber and the physiologic outflow path.

34. The implant of claim 33, wherein the inlet, intermediate and outlet sections comprise a substantially continuous tubular structure.

35. The implant of claim 33, wherein the inlet and intermediate sections have a combined length within the range of about 0.1 mm to about 3 mm.

36. The implant of claim 35, wherein the combined length of the inlet and intermediate sections is about 2 mm.

37. The implant of claim 26, wherein the inlet and outlet sections comprise a substantially continuous tubular structure.

38. The implant of claim 26, wherein the body has a multi-angular configuration.

39. The implant of claim 26, wherein the cross-sectional dimension of the outlet section is about 0.3 mm.

40. The implant of claim 26, wherein the outlet section has a length within the range of about 1 mm to about 40 mm.

41. The implant of claim 40, wherein the length of the outlet section is about 6 mm.

42. The implant of claim 26, wherein the outlet section has a pre-formed curve with a radius of about 6 mm.

43. The implant of claim 26, wherein the flow passage comprises a channel.

44. The implant of claim 43, wherein the channel comprises a lumen.

45. The implant of claim 44, wherein at least a portion of the lumen has a diameter or width within the range of about 0.1 mm to about 0.5 mm.

46. The implant of claim 45, wherein at least a portion of the lumen has a diameter or width of about 0.2 mm.