Shunt device and method for treating glaucoma

• US 6,626,858 B2
• Filed: 09/12/2002
• Issued: 09/30/2003
• Est. Priority Date: 04/26/1999
• Status: Active Grant

• 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:
  US10/242,385
• Publication Number:
  US 20030009124A1
• Time in Patent Office: 383 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 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 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, 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.

2. The shunt device of claim 1, wherein said distal portion of the shunt has an outer diameter of about 0.1 mm to 0.5 mm and a length of about 1 mm to 20 mm, and wherein said proximal portion has a length of about 0.1 to 3 mm.

3. The shunt device of claim 1, wherein said distal portion has a curve having a radius which approximates the radius of Schlemm'"'"'s canal of a human eye, wherein the radius is between about 3 mm and 10 mm.

4. The shunt device of claim 3, wherein said curve has a radius of about 6 mm.

5. The shunt device of claim 1, wherein the shunt is constructed of a flexible material.

6. The shunt device of claim 1, 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 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.

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

9. 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.

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

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

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

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

14. The shunt device of claim 1, wherein the distal portion has one or more fenestrations therein that allow the passage of fluid into Schlemm'"'"'s canal.

15. The shunt device of claim 1, wherein the proximal portion has one or more lumens therethrough that facilitate the passage of fluid into the distal portion of the shunt.

16. The shunt device of claim 15, wherein the proximal portion has two lumens therethrough that facilitate the passage of fluid into the distal portion of the shunt in opposite directions.

17. The shunt device of claim 1, wherein the proximal portion has one or more fenestrations therein that facilitate the passage of fluid into the distal portion of the shunt.

18. The shunt device of claim 17, wherein a 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.

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

20. The shunt device of claim 1, wherein at least a portion of the distal portion is selected from the group consisting of a round tubular channel, an ovoid tubular channel, a semi-tubular channel, and a partially open trough-like channel.

21. 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 one or more collecting channels of the eye.

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

23. 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.

24. 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 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, wherein the shunt device is non-linear prior to insertion.

25. The shunt device of claim 24, wherein said distal portion of the shunt has an outer diameter of about 0.1 mm to 0.5 mm and a length of about 1 mm to 20 mm, and wherein said proximal portion has a length of about 0.1 to 3 mm.

26. The shunt device of claim 24, wherein said distal portion has a curve having a radius which approximates the radius of Schlemm'"'"'s canal of a human eye, wherein the radius is between about 3 mm and 10 mm.

27. The shunt device of claim 26, wherein said curve has a radius of about 6 mm.

28. The shunt device of claim 24, 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.

29. The shunt device of claim 28, wherein the proximal portion of the shunt intersects the distal portion at about the midpoint of the length of the distal portion.

30. The shunt device of claim 24, wherein the distal portion extends in one direction within Schlemm'"'"'s canal.

31. The shunt device of claim 24, wherein the distal portion comprises a lumen that extends in either direction along Schlemm'"'"'s canal.

32. The shunt device of claim 24, wherein the device further comprises one or more unidirectional valves.

33. The shunt device of claim 24, 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.

34. The shunt device of claim 24, wherein said distal portion has an outer diameter of about 0.30 mm.

35. The shunt device of claim 24, wherein said proximal portion is tubular having a lumen with an internal diameter of between about 0.1 mm and 0.5 mm.

36. The shunt device of claim 24, wherein said proximal portion is tubular with a lumen with an internal diameter of about 0.2 mm.

37. The shunt device of claim 24, wherein said proximal portion has a length of about 2 mm.

38. The shunt device of claim 24, wherein said distal portion has a length of about 6 mm.

39. The shunt device of claim 24, wherein the distal portion has a lumen therethrough that allows the passage of fluid into Schlemm'"'"'s canal.

40. The shunt device of claim 24, wherein the distal portion has one or more fenestrations therein that allow the passage of fluid into Schlemm'"'"'s canal.

41. The shunt device of claim 24, wherein the proximal portion has one or more lumens therethrough that facilitate the passage of fluid into the distal portion of the shunt.

42. The shunt device of claim 41, wherein the proximal portion has two lumens therethrough that facilitate the passage of fluid into the distal portion of the shunt in opposite directions.

43. The shunt device of claim 24, wherein the proximal portion has one or more fenestrations therein that facilitate the passage of fluid into the distal portion of the shunt.

44. The shunt device of claim 43, wherein a 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.

45. The shunt device of claim 24, further comprising a plurality of proximal portions intersecting the distal portion.

46. The shunt device of claim 24, 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.

47. The shunt device of claim 24, wherein at least a portion of the distal portion is selected from the group consisting of a round tubular channel, an ovoid tubular channel, a semi-tubular channel, and a partially open trough-like channel.

48. The shunt device of claim 24, wherein at least a portion of the distal portion is a partially open trough-like channel open posteriorly toward one or more collecting channels of the eye.

49. The shunt device of claim 24, wherein at least a portion of the device is constructed from porous material.

50. The shunt device of claim 24, in which the terminal aspect of the proximal portion is angled internally towards the anterior chamber with respect to the proximal portion.

51. 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 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, wherein the shunt device is constructed of a flexible material and permits bi-directional fluid flow within Schlemm'"'"'s canal when inserted.

52. The shunt device of claim 51, wherein said distal portion of the shunt has an outer diameter of about 0.1 mm to 0.5 mm and a length of about 1 mm to 20 mm, and wherein said proximal portion has a length of about 0.1 to 3 mm.

53. The shunt device of claim 51, wherein said distal portion has a curve having a radius which approximates the radius of Schlemm'"'"'s canal of a human eye, wherein the radius is between about 3 mm and 10 mm.

54. The shunt device of claim 53, wherein said curve has a radius of about 6 mm.

55. The shunt device of claim 51, wherein the proximal portion of the shunt intersects the distal portion at about the midpoint of the length of the distal portion.

56. The shunt device of claim 51, 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.

57. The shunt device of claim 51, wherein said distal portion has an outer diameter of about 0.30 mm.

58. The shunt device of claim 51, wherein said proximal portion is tubular having a lumen with an internal diameter of between about 0.1 mm and 0.5 mm.

59. The shunt device of claim 51, wherein said proximal portion is tubular with a lumen with an internal diameter of about 0.2 mm.

60. The shunt device of claim 51, wherein said proximal portion has a length of about 2 mm.

61. The shunt device of claim 51, wherein said distal portion has a length of about 6 mm.

62. The shunt device of claim 51, wherein the distal portion has a lumen therethrough that allows the passage of fluid into Schlemm'"'"'s canal.

63. The shunt device of claim 51, wherein the distal portion has one or more fenestrations therein that allow the passage of fluid into Schlemm'"'"'s canal.

64. The shunt device of claim 51, wherein the proximal portion has one or more lumens therethrough that facilitate the passage of fluid into the distal portion of the shunt.

65. The shunt device of claim 64, wherein the proximal portion has two lumens therethrough that facilitate the passage of fluid into the distal portion of the shunt in opposite directions.

66. The shunt device of claim 51, wherein the proximal portion has one or more fenestrations therein that facilitate the passage of fluid into the distal portion of the shunt.

67. The shunt device of claim 66, wherein a 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.

68. The shunt device of claim 51, further comprising a plurality of proximal portions intersecting the distal portion.

69. The shunt device of claim 51, 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.

70. The shunt device of claim 51, wherein at least a portion of the distal portion is selected from the group consisting of a round tubular channel, an ovoid tubular channel, a semi-tubular channel, and a partially open trough-like channel.

71. The shunt device of claim 51, wherein at least a portion of the distal portion is a partially open trough-like channel open posteriorly toward one or more collecting channels of the eye.

72. The shunt device of claim 51, wherein at least a portion of the device is constructed from porous material.

73. The shunt device of claim 51, in which the terminal aspect of the proximal portion is angled internally towards the anterior chamber with respect to the proximal portion.