Shunt device and method for treating glaucoma

• US 6,450,984 B1
• Filed: 04/26/2000
• Issued: 09/17/2002
• Est. Priority Date: 04/26/1999
• Status: Expired due to Term

• Current Assignee: Glaukos Corporation
• Original Assignee: GMP Vision Solutions, Inc.
• Inventors: Brown, Reay H., Lynch, Mary G.
• Primary Examiner(s): Look, Edward K.
• Assistant Examiner(s): Edgar, Richard A.
• Application Number:
  US09/558,505
• Time in Patent Office: 874 Days
• Field of Search: 604/8, 604/264, 604/284, 604/523, 606/107, 623/4.1, 623/1.1, 623/11.11, 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 bidirectional flow of aqueous humor into Schlemm'"'"'s canal.

Claims

1. An aqueous humor shunt device to divert aqueous humor in an eye from the anterior chamber into Schlemm'"'"'s canal, the shunt device comprising a distal portion having at least one terminal aspect sized and shaped to be received circumferentially within a portion of Schlemm'"'"'s canal and a proximal portion having at least one terminal aspect sized and shaped to be received within the anterior chamber of the eye, wherein device permits fluid communication from the proximal portion in the anterior chamber to the distal portion in Schlemm'"'"'s canal.

2. The shunt device of claim 1, wherein the distal portion of the shunt has a curve having a radius which approximates the radius of Schlemm'"'"'s canal of a human eye.

3. The shunt device of claim 2, wherein said curve has a radius of between about 3 mm and 10 mm.

4. The shunt device of claim 2, wherein said curve has a radius of about 6 mm.

5. The shunt device of claim 1, wherein the proximal portion of the shunt intersects the distal portion and wherein the distal portion branches in two opposite directions from the intersection with the proximal portion permitting fluid communication from the anterior chamber in either direction along Schlemm'"'"'s canal.

6. The shunt device of claim 5, wherein the proximal portion of the shunt intersects the distal portion at about the midpoint of the length of the distal portion.

7. The shunt device of claim 1, wherein the distal portion extends in one direction within Schlemm'"'"'s canal.

8. The shunt device of claim 1, wherein the proximal portion extends from the distal portion at an angle to avoid occlusion from contact with corneal endothelium tissue or iris tissue when the distal portion is located within Schlemm'"'"'s canal.

9. The surgical device of claim 1, wherein said distal portion has an outer diameter of about 0.1 mm to 0.5 mm.

10. The shunt device of claim 1, wherein said distal portion has an outer diameter of about 0.30 mm.

11. The shunt device of claim 1, wherein said proximal portion is tubular having a lumen with an internal diameter of between about 0.1 mm and 0.5 mm.

12. The shunt device of claim 1, wherein said proximal portion is tubular with a lumen with an internal diameter of about 0.2 mm.

13. The shunt device of claim 1, wherein said proximal portion has a length of about 0.1 to 3 mm.

14. The shunt device of claim 1, wherein said proximal portion has a length of about 2 mm.

15. The shunt device of claim 1, wherein said distal portion has a length of about 1 mm to 20 mm.

16. The shunt device of claim 1, wherein said distal portion has a length of about 6 mm.

17. The shunt device of claim 1, where the distal portion has a lumen therethrough that allows the passage of fluid into Schlemm'"'"'s canal.

18. The shunt device of claim 1, where the distal portion has a plurality of fenestrations therein that allow the passage of fluid into Schlemm'"'"'s canal.

19. The shunt device of claim 1, where the proximal portion has a lumen therethrough that facilitates the passage of fluid into the distal portion of the shunt.

20. The shunt device of claim 1, where the proximal portion has two lumens therethrough that facilitates the passage of fluid into the distal portion of the shunt in opposite directions.

21. The shunt device of claim 1, where the proximal portion has a plurality of fenestrations therein that facilitate the passage of fluid into the distal portion of the shunt.

22. The shunt device of claim 21, wherein the lumen of the proximal portion communicates with one or more fenestrations oriented to open towards the inner surface of the cornea and away from the iris.

23. The shunt device of claim 1, further comprising a plurality of proximal portions intersecting the distal portion.

24. The shunt device of claim 1, in which an aqueous humor wicking extension of between about 1.0 mm to 16.0 mm in length extends from said terminal aspect of the distal portion.

25. The shunt device of claim 1, wherein at least a portion of the distal portion is a partially open trough-like channel open posteriorly toward the collecting channels of the eye.

26. The shunt device of claim 1, wherein at least a portion of the device is constructed from porous material.

27. The shunt device of claim 1, in which the terminal aspect of the proximal portion is angled internally towards the anterior chamber with respect to the proximal portion.

28. A method for the surgical treatment of glaucoma, comprising, performing a trabeculotomy through a conjunctival flap made at the limbus;

developing a partial thickness scleral flap;

radially incising the junction between the angle tissue and the sclera, which is surgically extended until Schlemm'"'"'s canal is entered posteriorly, and placing the shunt device of claim 1 between the anterior chamber and Schlemm'"'"'s canal.

29. An aqueous humor shunt device for use in an eye to relieve intraocular pressure by facilitating drainage from the anterior chamber of the eye into Schlemm'"'"'s canal, comprising:

a body of biocompatible material of a size and shape adapted to facilitate the passage of aqueous humor from the anterior chamber of the eye to and within Schlemm'"'"'s canal;

said body having a length and shape adapted to be at least partially circumferentially retained within a portion of Schlemm'"'"'s canal to facilitate the passage of aqueous humor from the anterior chamber to Schlemm'"'"'s canal.

30. The shunt device of claim 29, wherein the body of the shunt has a curve having a radius which approximates the radius of Schlemm'"'"'s canal of a human eye.

31. The shunt device of claim 30, wherein said curve has a radius of between about 3 mm and 10 mm.

32. The shunt device of claim 31, wherein said curve has a radius of about 6 mm.

33. The shunt device of claim 29, wherein the body has a proximal portion having at least one terminal aspect for placement within the anterior chamber and a distal portion having at least one terminal aspect for placement within Schlemm'"'"'s canal.

34. The shunt device of claim 33, wherein the proximal portion intersects the distal portion and wherein the distal portion branches in two opposite directions from the intersection with the proximal portion permitting fluid communication in either direction along Schlemm'"'"'s canal with the anterior chamber.

35. The shunt device of claim 34, wherein the proximal portion intersects the distal portion at or near the midpoint of the length of the distal portion.

36. The shunt device of claim 33, wherein the proximal portion extends from the distal portion at an angle sufficient to avoid occlusion from contact with corneal endothelium tissue or iris tissue when the distal portion is located within Schlemm'"'"'s canal.

37. The shunt device of claim 29, wherein the body defines a tubular channel along at least some of the length of said body.

38. The shunt device of claim 29, wherein said body is tubular and has an outer diameter of about 0.1 mm to 0.5 mm.

39. The shunt device of claim 29, wherein said body is tubular and has an outer diameter of about 0.3 mm.

40. The shunt device of claim 29, wherein said body has a length of about 1 mm to 20 mm.

41. The shunt device of claim 29, wherein said body has a length of about 6 mm.

42. The shunt device of claim 29, in which an aqueous humor wicking extension of between about 1.0 mm to 16.0 mm in length extends from said body.

43. The shunt device of claim 29, wherein the body defines a partially open trough-like channel open toward the collecting channels along at least some of the length of said body.

44. The shunt device of claim 29, wherein the body is fenestrated to provide communication with the lumen along at least some of the length of said body.

45. The shunt device of claim 29, wherein the body provides for drainage in one direction along Schlemm'"'"'s canal.

46. The shunt device of claim 29, wherein the body provides for drainage in both directions along Schlemm'"'"'s canal.

47. A method for the surgical treatment of glaucoma, comprising, performing a trabeculotomy through a conjunctival flap made at the limbus;

developing a partial thickness scleral flap;

radially incising the junction between the angle tissue and the sclera, which is surgically extended until Schlemm'"'"'s canal is entered posteriorly, and placing the shunt device of claim 29 between the anterior chamber and Schlemm'"'"'s canal.