Methods and apparatus for treating glaucoma

• US 8,267,882 B2
• Filed: 03/05/2009
• Issued: 09/18/2012
• Est. Priority Date: 03/05/2008
• Status: Active Grant

• Current Assignee: Alcon Incorporated
• Original Assignee: Ivantis Inc.
• Inventors: Euteneuer, Charles L., Hektner, Thomas R., Schieber, Andrew T., Wardle, John
• Primary Examiner(s): Zalukaeva, Tatyana
• Assistant Examiner(s): MARCETICH, ADAM M
• Application Number:
  US12/398,847
• Publication Number:
  US 20090227934A1
• Time in Patent Office: 1,293 Days
• Field of Search: 623/4.1, 623/6.64, 604/8, 604/27, 604/28, 604/48, 604/500, 604/540, 606/108
• US Class Current: 604/8
• CPC Class Codes: A61F 2009/00885 for treating a particular disease
• CPC Class Codes: A61F 2009/00891 Glaucoma
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61F 9/007 Methods or devices for eye surgery
• 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: A61K 9/0051 Ocular inserts, ocular implants
• CPC Class Codes: A61M 2210/0612 Eyes
• 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
• CPC Class Codes: Y10S 623/905 Eye
• CPC Class Codes: Y10S 623/906 Corneal

Abstract

An ocular implant for treating glaucoma is provided, which may include any number of features. More particularly, the present invention relates to implants that facilitate the transfer of fluid from within one area of the eye to another area of the eye. One feature of the implant is that it includes a proximal inlet portion and a distal inlet portion adapted to be inserted into the anterior chamber of the eye, and an intermediate portion adapted to be inserted into Schlemm'"'"'s canal. Another feature of the implant is that it can be biased to assume a predetermined shape to aid in placement within the eye.

Claims

1. A method of treating glaucoma in an eye of a patient, comprising:

positioning a first inlet portion of an implant in an anterior chamber of the eye and adjacent to a first opening in a trabecular mesh of the eye;

positioning a second inlet portion and an intermediate portion of the implant in Schlemm'"'"'s canal;

moving a tool inserted into the eye to make a second opening in the trabecular mesh of the eye near the second inlet portion, the second opening spaced apart from the first opening; and

allowing aqueous humor to flow from the anterior chamber into the implant and into Schlemm'"'"'s canal.

2. The method of claim 1 wherein the allowing step further comprises allowing aqueous humor to flow from the anterior chamber into the first and second inlet portions, through the intermediate portion, and into Schlemm'"'"'s canal.

3. The method of claim 1 wherein aqueous humor flows into Schlemm'"'"'s canal through a plurality of openings in the implant.

4. The method of claim 1 wherein the first inlet portion is spaced approximately 60 to 180 degrees from the second inlet portion.

5. The method of claim 1 wherein aqueous humor flows longitudinally along the implant.

6. The method of claim 5 wherein aqueous humor flows laterally across the implant.

7. The method of claim 1 further comprising allowing the second inlet portion to extend through the second opening in the trabecular mesh into the anterior chamber of the eye.

8. The method of claim 1 wherein the allowing step further comprises allowing aqueous humor to flow from the anterior chamber through the first and second inlet portions into Schlemm'"'"'s canal.

9. A method of treating glaucoma in an eye of a patient, comprising:

inserting a cannula into an anterior chamber of the eye so that a distal tip of the cannula is in communication with Schlemm'"'"'s canal;

inserting a distal inlet portion of the implant through the cannula into Schlemm'"'"'s canal;

advancing the implant distally through the cannula and along Schlemm'"'"'s canal until only a proximal inlet portion of the implant remains in the cannula;

removing the cannula from the anterior chamber of the eye leaving the proximal inlet portion of the implant in the anterior chamber of the eye; and

introducing the distal inlet portion of the implant into the anterior chamber of the eye from Schlemm'"'"'s canal.

10. The method of claim 9 wherein the introducing step comprises:

advancing a tissue penetrating guide wire distally from the implant to penetrate into the anterior chamber of the eye from Schlemm'"'"'s canal;

advancing the implant over the guide wire to introduce the distal inlet portion of the implant into the anterior chamber of the eye from Schlemm'"'"'s canal.

11. The method of claim 9 wherein the introducing step comprises:

making an incision from the anterior chamber of the eye into Schlemm'"'"'s canal at a position near the distal inlet portion of the implant;

allowing the distal inlet portion of the implant to assume a predetermined at rest shape which results in the distal inlet portion bending through the incision into the anterior chamber of the eye from Schlemm'"'"'s canal.

12. The method of claim 9 wherein the proximal inlet portion is spaced approximately 60 to 180 degrees from the distal inlet portion.

13. The method of claim 9 further comprising:

inserting a core into a lumen defined by the implant; and

inserting a guide wire into a guide wire lumen defined by the core.

14. The method of claim 13 wherein the core is disposed in the lumen defined by the implant while the implant is advanced distally along Schlemm'"'"'s canal.

15. The method of claim 13 wherein the guide wire is disposed in the guide wire lumen defined by the core while the implant is advanced distally along Schlemm'"'"'s canal.

16. The method of claim 13 wherein the introducing step comprises:

advancing a distal portion of the guide wire distally from the core to penetrate into the anterior chamber of the eye from Schlemm'"'"'s canal; and

advancing the implant off of the core and over the guide wire to introduce the distal inlet portion of the implant into the anterior chamber of the eye from Schlemm'"'"'s canal.

17. The method of claim 16 wherein:

the distal portion of the guide wire is urged to assume a stressed shape when the distal portion of the guide wire is disposed in the guidewire lumen; and

the distal portion of the guide wire is free to assume a predetermined at rest shape when the distal portion of the guide wire is advanced distally from the core.

18. The method of claim 17 wherein the distal portion of the guide wire has a distal radius of curvature when the distal portion of the guide wire is free to assume the predetermined at rest shape.

19. The method of claim 18 wherein:

a proximal portion of the guide wire has a proximal radius of curvature; and

the proximal radius of curvature is generally greater than the distal radius of curvature.

20. The method of claim 18 wherein:

a proximal portion of the guide wire has a proximal radius of curvature different from the distal radius of curvature; and

the proximal radius of curvature approximates the curvature of Schlemm'"'"'s canal.

21. The method of claim 13, wherein the implant comprises a first material and the core comprises a second material different from the first material.

22. The method of claim 21, wherein the first material and the second material comprise materials which provide a relatively low friction interface when placed in sliding contact with one another.

23. The method of claim 22, wherein:

an interface between two samples of the first material has a first coefficient of friction;

an interface between a sample of the first material and a sample of the second material has a second coefficient of friction; and

the first coefficient of friction is greater than the second coefficient of friction.

24. The method of claim 21, wherein the first material and the second material comprise materials which are unlikely to gall when placed in sliding contact with one another.

25. The method of claim 21, wherein the first material comprises a metallic material and the second material comprises a polymeric material.

26. The method of claim 13, wherein the guide wire comprises a first material and the core comprises a second material different from the first material.

27. The method of claim 26, wherein the first material and the second material comprise materials which provide a relatively low friction interface when placed in sliding contact with one another.

28. The method of claim 27, wherein:

an interface between two samples of the first material has a first coefficient of friction;

an interface between a sample of the first material and a sample of the second material has a second coefficient of friction; and

the first coefficient of friction is greater than the second coefficient of friction.

29. The method of claim 26, wherein the first material and the second material comprise materials which are unlikely to gall when placed in sliding contact with one another.

30. The method of claim 26, wherein the first material comprises a metallic material and the second material comprises a polymeric material.

31. The method of claim 9, further comprising flushing the cannula with a fluid.

32. The method of claim 31, wherein the flushing is performed prior inserting a distal end of the cannula into the anterior chamber for preventing the introduction of air bubbles into the anterior chamber of the eye.

33. The method of claim 9, further comprising injecting a bolus of viscoelastic material proximate a target location in the anterior chamber of the eye.

34. The method of claim 33, further comprising piercing a wall of Schlemm'"'"'s canal with a distal end of the cannula at the target location.

35. The method of claim 34, wherein the bolus of viscoelastic material is injected prior to piercing the wall of Schlemm'"'"'s canal for precluding the formation of a pool of blood near the target location.

36. The method of claim 33, further comprising piercing a trebecular mesh of the eye with a distal end of the cannula at the target location.

37. The method of claim 9 wherein the introducing step comprises:

advancing a self-piercing distal inlet in a distal direction to cause the distal inlet to cut through Schlemm'"'"'s canal into the anterior chamber.

38. The method of claim 37 wherein the self-piercing distal inlet is advanced while the distal inlet portion is biased inwards.