Shunt device and method for treating glaucoma

• US 6,827,700 B2
• Filed: 05/27/2003
• Issued: 12/07/2004
• 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:
  US10/445,740
• Publication Number:
  US 20030220603A1
• Time in Patent Office: 560 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 bi-directional flow of aqueous humor into Schlemm'"'"'s canal.

Claims

1. An ocular device comprising:

a solid-walled tubular body for implantation into Schlemm'"'"'s canal of a living eye comprising a portion for insertion into said canal, and a portion sized to extend from a position within said canal to a position within an anterior chamber of said eye; and

wherein said tubular body comprises a metal and is configured and dimensioned such that implantation of said tubular body in living tissue of said canal permits dynamic flow of aqueous humor toward an episcleral venous system of said eye.

2. The ocular device of claim 1, wherein said tubular body comprises a proximal end with an opening, said proximal end being oriented between 0°

and 90°

with respect to a line extending between respective ends of said canal.

3. The ocular device of claim 1, wherein said tubular body comprises a proximal end with an opening, said proximal end being oriented between 0°

and 45°

with respect to a line extending between respective ends of said canal.

4. The ocular device of claim 1, wherein said tubular body comprises open ends and is configured and dimensioned to permit communication between said open ends of substantially all aqueous humor entering said tubular body.

5. The ocular device of claim 1, wherein said tubular body defines an aqueous humor directing channel extending between ends of said tubular body that is sized to permit flow of aqueous humor therein.

6. The ocular device of claim 5, wherein said aqueous humor directing channel in said tubular body is sized to wick aqueous humor therein.

7. The ocular device of claim 1, wherein said tubular body further comprises a therapeutic agent.

8. The ocular device of claim 1, wherein said flexible portion of said tubular body is adapted to conform to a radius of curvature of 6 mm.

9. The ocular device of claim 1, wherein said tubular body comprises first and second integrally formed sections disposed transverse to each other.

10. The ocular device of claim 1, wherein said tubular body is configured and dimensioned to permit dynamic flow of aqueous humor at a flow rate below about 2.5 microliters per minute.

11. The ocular device of claim 1, wherein said tubular body is configured and dimensioned to permit dynamic flow of aqueous humor at a flow rate sufficient to maintain eye pressure above 6.0 mmHg.

12. The ocular device of claim 1, wherein said tubular body is configured and dimensioned to permit dynamic flow of aqueous humor at a flow rate that maintains eye pressure between 15 mmHg and 21 mmHg.

13. The ocular device of claim 1, wherein said tubular body has an inner diameter of between 0.1 mm and 0.5 mm.

14. The ocular device of claim 1, wherein said tubular body defines an aqueous humor directing channel with a maximum width between 0.2 mm and 0.5 mm.

15. The ocular device of claim 1, wherein said tubular body further comprises an anchor portion for stabilizing the tubular body in Schlemm'"'"'s canal.

16. The ocular device of claim 1, wherein said tubular body comprises an arcuate outer surface.

17. The ocular device of claim 1, wherein said tubular body comprises a cylindrical outer cross-section.

18. The ocular device of claim 1, wherein said tubular body is curved.

19. An ocular device comprising:

a solid-walled tubular body for implantation into Schlemm'"'"'s canal of a living eye wherein at least a portion of the tubular device comprises a non-linear aqueous humor directing channel; and

wherein said tubular body is configured and dimensioned such that implantation of said tubular body in living tissue of said canal directs dynamic flow of aqueous humor from an anterior chamber of said living eye and through said non-linear aqueous humor directing channel toward episcleral veins.

20. The device of claim 19, wherein a portion of the device inserts into the anterior chamber of the eye.

21. The device of claim 19, wherein the device comprises a metal.

22. The device of claim 19, wherein at least a portion of said tubular body comprises a rigid portion.

23. The device of claim 19, wherein the device comprises a therapeutic agent.

24. The device of claim 19, wherein the device comprises a T-shape.

25. The device of claim 24, wherein one portion of the T-shaped device inserts into the anterior chamber of the eye, and two portions of the device insert within Schlemm'"'"'s canal in a substantially bi-directional manner.

26. The device of claim 19, wherein the device comprises a V-shape.

27. The ocular device of claim 26, wherein at least a portion of said tubular body is shaped as an open trough.

28. The ocular device of claim 26, wherein said tubular body comprises first and second elongate lumens.

29. The ocular device of claim 28, wherein a portion of the first elongate lumen is parallel to a portion of the second elongate lumen.

30. The ocular device of claim 29, wherein the first and second elongate lumens are separated from each other.

31. The ocular device of claim 28, wherein a portion of the first elongate lumen is disposed transverse to a portion of the second elongate lumen.

32. An ocular device comprising:

a solid-walled tubular body adapted to be received in Schlemm'"'"'s canal of a living eye;

wherein the tubular body is dimensioned to allow non-linear fluid communication; and

wherein said tubular body is configured and dimensioned such that implantation of said tubular body in living tissue of said canal directs dynamic flow of aqueous humor toward episcleral veins.

33. The device of claim 32, wherein a portion of the device inserts into the anterior chamber of the eye.

34. The device of claim 32, wherein the device comprises a metal.

35. The device of claim 32, wherein the device comprises a therapeutic agent.

36. The device of claim 32, wherein the device comprises a T-shape.

37. The device of claim 36, wherein one portion of the T-shaped device inserts into the anterior chamber of the eye, and two portions of the device insert within Schlemm'"'"'s canal in a substantially bi-directional manner.

38. The device of claim 32, wherein the device comprises a V-shape.

39. An aqueous humor shunt device for implantation in a living eye having an anterior chamber and a Schlemm'"'"'s canal for diverting aqueous humor 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,

wherein one or both of the proximal portion or the distal portion comprises an aqueous humor directing channel;

wherein the device permits fluid communication from the proximal portion in the anterior chamber to the distal portion in Schlemm'"'"'s canal,

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.

40. The shunt device of claim 39, wherein the proximal portion of the shunt intersects the distal portion at about the midpoint of the length of the distal portion.

41. The shunt device of claim 39, wherein the distal portion comprises a lumen therethrough that directs the passage of fluid into Schlemm'"'"'s canal.

42. The shunt device of claim 39, wherein the distal portion comprises a plurality of fenestrations that allow the passage of fluid into Schlemm'"'"'s canal.

43. The shunt device of claim 39, wherein the proximal portion has a lumen therethrough that facilitates the passage of fluid into the distal portion of the shunt.

44. The shunt device of claim 39, wherein the proximal portion has two lumens therethrough that facilitate the passage of fluid into the distal portion of the shunt in opposite directions.

45. The shunt device of claim 39, wherein the proximal portion has a plurality of fenestrations therein that facilitate the passage of fluid into the distal portion of the shunt.

46. The shunt device of claim 43, wherein the lumen of the proximal portion communicates with one or more fenestrations.

47. An aqueous humor shunt device for use in a living eye having an anterior chamber and a Schlemm'"'"'s canal for relieving intraocular pressure by facilitating drainage from the anterior chamber of the living eye into Schlemm'"'"'s canal, the shunt device comprising:

a body formed of material of a size and shape adapted to facilitate the passage of aqueous humor from the anterior chamber 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;

said body comprising 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;

wherein one or both of the proximal portion or the distal portion comprises an aqueous humor directing channel;

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.