Shunt device and method for treating ocular disorders

• US 9,827,143 B2
• Filed: 11/11/2016
• Issued: 11/28/2017
• Est. Priority Date: 04/26/1999
• Status: Expired due to Fees

• Current Assignee: Glaukos Corporation
• Original Assignee: Glaukos Corporation
• Inventors: Lynch, Mary G., Brown, Reay H.
• Primary Examiner(s): DEAK, LESLIE R
• Application Number:
  US15/349,885
• Publication Number:
  US 20170216095A1
• Time in Patent Office: 382 Days
• Field of Search: 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 implant configured to maintain patency of Schlemm'"'"'s canal in a stenting fashion, the ocular implant comprising:

a body of biocompatible material of a size and shape adapted to be at least partially circumferentially retained within a portion of Schlemm'"'"'s canal,

wherein the body is non-tubular,

wherein the body is curved, and

wherein the body comprises at least one opening along its length configured to facilitate passage of aqueous humor.

2. The ocular implant of claim 1, wherein a portion of the body is oriented to be positioned in the anterior chamber after implantation.

3. The ocular implant of claim 1, wherein the body is shaped to facilitate flow of aqueous humor from Schlemm'"'"'s canal into one or more collecting channels.

4. The ocular implant of claim 1, wherein the body is elongate and comprises multiple ovoid openings along its length.

5. An implant designed to relieve excessive intraocular pressure, the implant comprising:

a flexible, elongate body of biocompatible material for implantation in a living human eye comprising a curved channel shaped to be at least partially positioned within a circumferential length of Schlemm'"'"'s canal;

wherein the channel is at least partially open along its length to facilitate flow of aqueous humor from Schlemm'"'"'s canal into one or more collecting channels;

the channel further having one or more portals oriented to allow flow of aqueous humor from an anterior chamber of the eye into Schlemm'"'"'s canal.

6. The implant of claim 5, wherein the channel has a trough-like shape to provide stenting support for the patency of Schlemm'"'"'s canal.

7. The implant of claim 5, wherein the channel includes multiple portals along its length.

8. The implant of claim 7, wherein at least some of the portals are ovoid in shape.

9. The implant of claim 5, wherein a distal portion of the elongate body comprises the curved channel, and wherein the elongate body further comprises a proximal portion that is oriented to be positioned at least partially in the anterior chamber after implantation.

10. The implant of claim 9, wherein the proximal portion is at least partially open to receive aqueous humor from the anterior chamber, and wherein the proximal portion is in fluid communication with the distal portion to facilitate flow of aqueous humor into Schlemm'"'"'s canal.

11. The implant of claim 5, wherein the biocompatible material comprises metal.

12. The implant of claim 5, wherein a distal end of the body is non-tubular.

13. The implant of claim 5, wherein the opening along the length of the channel is oriented toward one or more of the collecting channels when located within Schlemm'"'"'s canal.

14. The implant of claim 5, wherein the opening along the length of the channel extends to a distal end of the body.

15. The implant of claim 5, wherein the channel is open along a length that extends to a distal end of the body.

16. An implant designed to relieve excessive intraocular pressure, the implant comprising:

a body of biocompatible material for implantation in a living human eye, wherein the body has a non-linear shape before insertion into the eye;

the body comprising a channel shaped to be at least partially positioned within a circumferential length of Schlemm'"'"'s canal;

wherein the channel is at least partially open along its length and oriented to facilitate flow of aqueous humor from Schlemm'"'"'s canal into one or more collecting channels.

17. The implant of claim 16, wherein a distal portion of the body comprises the channel, and wherein the body further comprises a proximal portion that is oriented to be positioned at least partially in an anterior chamber of the eye after implantation.

18. The implant of claim 17, wherein the proximal portion comprises an opening to receive aqueous humor from the anterior chamber, and wherein the proximal portion is in fluid communication with the distal portion to facilitate flow of aqueous humor into Schlemm'"'"'s canal.

19. The implant of claim 18, wherein the proximal portion is shorter in length than the distal portion.

20. The implant of claim 16, wherein the biocompatible material comprises metal.

21. The implant of claim 16, wherein a distal end of the body is non-tubular.

22. The implant of claim 16, wherein the opening along the length of the channel extends to a distal end of the body.

23. The implant of claim 16, wherein the channel is open along a length that extends to a distal end of the body.

24. An implant designed to relieve excessive intraocular pressure, the implant comprising:

a biocompatible metal stent shaped to be partially circumferentially positioned within a length of Schlemm'"'"'s canal in a living human eye;

wherein the stent comprises a non-tubular open shape to provide stenting support for the patency of Schlemm'"'"'s canal and to improve flow of aqueous humor into Schlemm'"'"'s canal after implantation of the stent;

wherein at least one cross-section of the stent approximates a partial circumference of a circle having an inner diameter between about 100 micrometers and 500 micrometers.

25. The implant of claim 24, wherein a portion of the stent is oriented to be positioned in an anterior chamber of the eye after implantation.

26. The implant of claim 24, wherein the stent has a non-linear shape before insertion into the eye.

27. The implant of claim 24, wherein the stent is elongate and further includes multiple holes along its length.

28. The implant of claim 27, wherein at least some of the holes are oval-shaped.

29. The implant of claim 24, wherein the non-tubular open shape of the stent is disposed to facilitate flow of aqueous humor into one or more collecting channels in the eye.

30. The implant of claim 24, wherein the at least one cross-section is approximately semi-circular.

31. The implant of claim 24, wherein the stent is oriented so as to open toward one or more of the collecting channels when located within Schlemm'"'"'s canal.

32. A surgical method for relieving excessive intraocular pressure by implanting a medical device in an eye, the method comprising:

inserting a non-luminal open stent into a living human eye, wherein at least one cross-section of the stent approximates a partial circumference of a circle having an inner diameter between about 100 micrometers and 500 micrometers;

creating an incision in a trabecular meshwork of the eye;

positioning the stent through the incision so that the stent is partially located in an anterior chamber of the eye and partially located within a circumferential length of Schlemm'"'"'s canal in the eye;

leaving the stent in the eye as a permanent implant to permit increased flow of aqueous humor from the anterior chamber into Schlemm'"'"'s canal.

33. The method of claim 32, wherein the stent provides stenting support for the patency of Schlemm'"'"'s canal.

34. The method of claim 32, wherein the stent is oriented to open toward one or more collecting channels of the eye to facilitate flow of aqueous humor.

35. The method of claim 34, wherein the portion of the stent positioned in Schlemm'"'"'s canal further includes multiple openings along its length through which aqueous humor is permitted to flow from the anterior chamber into Schlemm'"'"'s canal.

36. The method of claim 32, wherein the stent is flexible and comprises a biocompatible metal.

37. The method of claim 32, wherein the stent has a non-linear shape before insertion into the eye.

38. An implant for relieving excessive intraocular pressure, the implant comprising:

a non-luminal, elongated body of biocompatible material for implantation in a living human eye, the body comprising,

a channel shaped to be at least partially positioned within a circumferential length of Schlemm'"'"'s canal, wherein the channel is at least partially open along a length of the body and is oriented to open toward one or more collecting channels when implanted in the eye; and

a portal that is generally adjacent to an inner wall of Schlemm'"'"'s canal when the body is implanted in the eye, so as to allow flow of aqueous humor from an anterior chamber through trabecular meshwork and into Schlemm'"'"'s canal.

39. The implant of claim 38, wherein the portal in the body is oval-shaped.

40. The implant of claim 39, wherein the body includes multiple oval-shaped portals along the length of the channel.

41. The implant of claim 38, wherein at least one cross-section of the body approximates a partial circumference of a circle having an inner diameter between about 100 micrometers and 500 micrometers.

42. The implant of claim 38, wherein the channel is open along a length that extends to a distal end of the body.