Method and apparatus for lowering the intraocular pressure of an eye

• US 6,102,045 A
• Filed: 12/24/1997
• Issued: 08/15/2000
• Est. Priority Date: 07/22/1994
• Status: Expired due to Term

• Current Assignee: Wound Healing of Oklahoma
• Original Assignee: Premier Laser Systems, Inc.
• Inventors: Li, Bing, Nordquist, Robert E.
• Primary Examiner(s): Nguyen, Dinh X.
• Application Number:
  US08/998,875
• Time in Patent Office: 965 Days
• Field of Search: 623/4, 623/4.1, 128/898, 604/8-10, 604/294, 604/296
• US Class Current: 128/898
• CPC Class Codes: A61F 9/00781 Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment drainage implants in general A61M27/002

Abstract

A method and apparatus for lowering the intraocular pressure of an eye are provided. The apparatus is a filtering implant comprising a cellulosic membrane adapted to extend from the anterior chamber of the eye through an opening in the limbus corneae to a drainage area beneath a scleral flap. In its most preferred embodiment, the cellulosic membrane consists essentially of a homopolymer of glucose units connected in a 1,4'"'"'-β linkage. The implant is of a planar, generally rectangular shape. The method involves preparing and implanting the device within the eye such that it extends from the anterior chamber of the eye through an opening in the limbus corneae to a drainage area beneath a scleral flap.

Claims

1. A method for lowering the intraocular pressure of an eye, which comprises positioning an implant within the eye such that said implant extends from the anterior chamber of the eye through an opening in the limbus corneae to a drainage area beneath a scleral flap.

2. The method according to claim 1, wherein said implant is of a planar, generally rectangular shape having a proximal end, a distal end, and outer margins, said margins toward said proximal end forming a foot portion for placement in the anterior chamber and a body portion opposed to said foot portion for burial beneath the scleral flap.

3. The method according to claim 2, wherein said implant has a center cut axially extending from said proximal end toward said distal end such that said foot portion can be folded for easy insertion through the opening in the limbus corneae.

4. The method according to claim 2, wherein said implant is of a thickness of approximately 25-150 microns.

5. The method according to claim 2, wherein the overall length of said implant is approximately 8-10 mm and the overall width is approximately 6 mm.

6. The method of claim 2, wherein two opposing rectangular notches are formed in said margins toward said proximal end so as to form said foot portion.

7. The method according to claim 6, wherein said foot portion has a length of approximately 1 mm and a width of approximately 6 mm, said two opposing rectangular notches measure approximately 1 mm in length and 1.5 mm in width, and said body portion has a length of approximately 8 mm and a width of approximately 6 mm.

8. The method according to claim 2, wherein said foot portion is provided with at least one curved, resilient arm member radially extending therefrom for abutting the inner surface of the limbus corneae after implantation so as to maintain the post-surgical position of said implant.

9. The method according to claim 2, wherein said proximal end has an integrally formed key projecting therefrom for placement through said opening and into said anterior chamber, said key having at least one curved, resilient arm member radially extending therefrom for abutting the inner surface of the limbus corneae after implantation so as to maintain the post-surgical position of said implant.

10. The method according to claim 9, wherein said key is center cut to divide said key into a first piece and a second piece such that said key can be folded for easy insertion through the opening in the limbus corneae.

11. The method according to claim 10, wherein said key has two curved, resilient arm members, a first arm member radially extending from said first piece and a second arm member radially extending from said second piece.

12. The method according to claim 9, wherein said arm member is formed of a bio-compatible material and is fixed to said foot portion with bio-compatible adhesive.

13. The method according to claim 9, wherein said arm member is formed of a bio-compatible material and is formed integrally to said foot portion.

14. The method according to claim 1, wherein said implant has at least a first notch provided therein which defines a foot portion of said implant which is placed through said opening and into the anterior chamber of the eye and wherein said first notch further defines a body portion of said implant which is placed beneath the sclera flap.

15. The method according to claim 14, wherein:

said first notch defines a first shoulder on said foot portion;

said first notch defines a second shoulder on said body portion, said second shoulder being opposed to said first shoulder; and

said first notch has a width such that said first shoulder will remain in abutment with the inner surface of the limbus corneae and said second shoulder will remain in abutment with the outer surface of the limbus corneae.

16. The method according to claim 15, wherein:

said device further includes a second notch opposed to said first notch;

said second notch defines a third shoulder on said foot portion

said second notch defines a fourth shoulder on said body portion, said fourth shoulder being opposed to said third shoulder; and

said second notch having a width such that said third shoulder will remain in abutment with the inner surface of the limbus corneae and said fourth shoulder will remain in abutment with the outer surface of the limbus corneae.

17. The method according to claim 1, wherein said implant comprises:

a foot portion placed in the anterior chamber of the eye;

a body portion placed beneath the scleral flap; and

a neck portion between said foot portion and said body portion.

18. The method according to claim 17, wherein said neck portion acts as a permanent fistula through the limbus corneae.

19. The method according to claim 17, wherein said implant has an exterior surface and said implant produces drainage of aqueous humor primarily through said foot, neck and body portions rather than over said exterior surface.

20. The method according to claim 19, wherein said implant has no tube or other mechanically created flow passage extending therethrough.

21. The method according to claim 17, wherein said implant regulates aqueous humor flow in a manner substantially the same as that of the trabecular meshwork of the eye.

22. The method according to claim 17, wherein said implant has a microstructure which provides regulated drainage of aqueous humor through said foot, body, and neck portions.

23. The method according to claim 17, wherein said implant is a filtering implant.

24. The method according to claim 23, wherein said implant provides drainage of aqueous humor therethrough without permitting any substantial leeching of proteins and particulates from the aqueous humor.

25. The method according to claim 1 wherein said implant comprises a bio-compatible material which is electrically neutral.

26. The method according to claim 1 wherein a portion of said implant is positioned beneath said scleral flap and said portion comprises a material which will promote formation of a fluid-dissipating, fibrovascular network around said portion and wherein said fibrovascular network will not substantially bind to said portion.

27. The method according to claim 26 wherein, after healing occurs, said implant will operate to lower said intraocular pressure substantially without the presence of a filter bleb on said eye.