DEVICES AND METHODS FOR OPENING FLUID PASSAGEWAYS

• US 20090204053A1
• Filed: 02/11/2008
• Published: 08/13/2009
• Est. Priority Date: 02/11/2008
• Status: Active Grant

• Current Assignee: Alcon Incorporated
• Original Assignee: Optonol, Ltd. (Alcon Incorporated)
• Inventors: Ben-Zvi, Jonathan, Yaron, Ira, Nissan, Oded
• Granted Patent: US 8,109,896 B2
• Time in Patent Office: Days
• US Class Current: 604/8
• CPC Class Codes: A61F 9/00781 Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment drainage implants in general A61M27/002

Abstract

Devices and procedures for assisting drainage of aqueous humor from the eye are provided. In accordance with some embodiments, an implant sized to fit within the Schlemm'"'"'s Canal is provided. The implant has a plurality of penetrating members having an unextended position in which the penetrating members lie generally close to the longitudinal axis of the implant and an extended position in which the penetrating members are extended outward. In use, the implant is advanced around at least a substantial portion of the Schlemm'"'"'s Canal with the penetrating members in the first unextended position. After the implant is positioned within the Schlemm'"'"'s Canal, the penetrating members are caused to move from the first unextended position to the second extended position, wherein the penetrating members penetrate the wall of the Schlemm'"'"'s Canal. This creates fluid passageways in the wall of the Schlemm'"'"'s Canal. The implant can also serve to keep the Schlemm'"'"'s Canal open. A delivery device is also provided for implanting an implant into the Schlemm'"'"'s Canal.

Claims

1. An implant for assisting drainage of aqueous humor from the eye, said implant sized to fit within the Schlemm'"'"'s Canal of the eye, said implant having a longitudinal axis and comprising a plurality of penetrating members, wherein each of said penetrating members has a first unextended position in which said penetrating member lies generally close to said longitudinal axis of the implant and a second extended position in which said penetrating member is extended outward to be farther away from the longitudinal axis of the implant.

2. The implant of claim 1, wherein said implant comprises a longitudinally flexible body.

3. The implant of claim 2, wherein said longitudinally flexible body comprises at least one longitudinally flexible rod.

4. The implant of claim 2, wherein said longitudinally flexible body comprises two longitudinally flexible rods.

5. The implant of claim 1, wherein said penetrating members lie substantially in a single plane when said penetrating members are in said first unextended position.

6. The implant of claim 1, wherein said implant has a rod-like profile when said penetrating members are in said first unextended position.

7. The implant of claim 1, wherein each penetrating member comprises at least one penetrating tip.

8. The implant of claim 1, wherein said implant comprises a longitudinally flexible body, wherein each penetrating member comprises at least one penetrating tip, and wherein each penetrating member further comprises at least one supporting arm connecting the penetrating tip to the longitudinally flexible body at a hinge.

9. The implant of claim 7, wherein each penetrating tip is connected to said longitudinally flexible body by two supporting arms, with each of the two supporting arms extending between the penetrating tip and the longitudinally flexible body and connected to the longitudinally flexible body at a hinge.

10. The implant of claim 1, wherein said penetrating members are configured to self-expand from said first unextended position to said second extended position.

11. The implant of claim 1, wherein the penetrating members comprise a resilient material, wherein in an unconstrained state said penetrating members are in said second extended position, and wherein in a constrained state said penetrating members are held in said first unextended position.

12. The implant of claim 11, further comprising a sheath around the implant wherein said sheath holds the penetrating members in said first unextended position.

13. The implant of claim 1, wherein the penetrating members comprise a shape memory material, wherein the heat from the eye causes the penetrating members to move from the first unextended position to the second extended position.

14. The implant of claim 1, wherein said implant comprises a deployment rod attached to said penetrating members, and wherein actuation of said deployment rod causes the penetrating members to move from the first unextended position to the second extended position.

15. The implant of claim 1, wherein said implant comprises a longitudinally flexible body, wherein each penetrating member comprises at least one penetrating tip, wherein each penetrating member further comprises at least one supporting arm connecting the penetrating tip to the longitudinally flexible body at a hinge, wherein said implant comprises a deployment rod attached to said penetrating members, and wherein actuation of said deployment rod causes the penetrating members to move from the first unextended position to the second extended position.

16. The implant of claim 15, wherein actuation of said deployment rod is performed by moving said deployment rod relative to said longitudinally flexible body.

17. The implant of claim 1, wherein when said penetrating members are in said first unextended position, said penetrating members generally point in a proximal direction along the longitudinal axis of the implant, wherein advancing the implant in a distal direction does not cause said penetrating members to become extended, and wherein retracting the implant in a proximal direction back through the Schlemm'"'"'s Canal causes said penetrating members to move from the first unextended position to the second extended position.

18. The implant of claim 1, wherein said implant is coated with a drug that elutes from the surface of the implant.

19. The implant of claim 1, wherein when the penetrating members are in the first unextended position, the cross-sectional profile of the implant has a height from about 0.05 mm to about 1 mm and a width from about 0.015 mm to about 0.25 mm.

20. The implant of claim 1, wherein when the penetrating members are in the second extended position, the cross-sectional profile of the implant has a width from about 0.03 mm to about 1 mm.

21. The implant of claim 1, wherein the implant has a length of at least 1 mm.

22. The implant of claim 1, further comprising an ultrasonic guide tube around the implant.

23. The implant of claim 1, further comprising a cleaning guide tube around the implant.

24. A delivery device for implanting an implant for assisting drainage of aqueous humor from the eye, said delivery device comprising:

a generally longitudinally extending shaft;

a piercing tip at a distal end of the shaft; and

a lumen passing through said longitudinally extending shaft for accommodating an implant.

25. The delivery device of claim 24, wherein said longitudinally extending shaft further comprises a lumen for viscoelastic injection.

26. The delivery device of claim 24, wherein said longitudinally extending shaft further comprises a lumen for an imaging device.

27. The delivery device of claim 24, wherein said longitudinally extending shaft further comprises a light source.

28. The delivery device of claim 24, wherein said longitudinally extending shaft further comprises a lumen for irrigation.

29. The delivery device of claim 24, housing an implant for assisting drainage of aqueous humor from the eye, said implant sized to fit within the Schlemm'"'"'s Canal of the eye, said implant having a longitudinal axis and comprising a plurality of penetrating members, wherein each of said penetrating members has a first unextended position in which said penetrating member lies generally close to said longitudinal axis of the implant and a second extended position in which said penetrating member is extended outward to be farther away from the longitudinal axis of the implant.

30. A method of implanting an implant for assisting drainage of aqueous humor from the eye, said method comprising:

providing an implant sized to fit within the Schlemm'"'"'s Canal of the eye, said implant having a longitudinal axis and comprising a plurality of penetrating members, wherein each of said penetrating members has a first unextended position in which said penetrating member lies generally close to said longitudinal axis of the implant and a second extended position in which said penetrating member is extended outward to be farther away from the longitudinal axis of the implant;

forming an access opening into the Schlemm'"'"'s Canal;

inserting said implant into the Schlemm'"'"'s Canal through said opening;

advancing said implant around at least a substantial portion of said Schlemm'"'"'s Canal with said penetrating members in said first unextended position; and

causing said penetrating members to move from said first unextended position to said second extended position, wherein said penetrating members penetrate the wall of the Schlemm'"'"'s Canal.

31. The method of claim 30, wherein the step of advancing said implant involves advancing said implant approximately 360 degrees around Schlemm'"'"'s Canal.

32. The method of claim 30, wherein the step of forming an access opening into the Schlemm'"'"'s Canal involves forming an access opening ab externo under a scleral flap.

33. The method of claim 30, wherein the step of forming an access opening into the Schlemm'"'"'s Canal involves forming an access opening ab interno by forming an incision in the cornea and accessing the Schlemm'"'"'s canal from through the anterior chamber of the eye.

34. The method of claim 30, further comprising delivering the implant to the opening in the Schlemm'"'"'s canal by a delivery device comprising a generally longitudinally extending shaft with a piercing tip and a lumen passing through said longitudinally extending shaft for accommodating an implant.

35. The method of claim 30, wherein said penetrating members are configured to self-expand from said first unextended position to said second extended position, and wherein the step of causing said penetrating members to move from said first unextended position to said second extended position involves allowing the penetrating members to self-expand.

36. The method of claim 30, wherein the penetrating members comprise a resilient material, wherein in an unconstrained state said penetrating members are in said second extended position, and wherein in a constrained state said penetrating members are held in said first unextended position.

37. The method of claim 36, further comprising a sheath around the implant wherein said sheath holds the penetrating members in said first unextended position, and wherein the step of causing said penetrating members to move from said first unextended position to said second extended position involves withdrawing the sheath.

38. The method of claim 30, wherein the penetrating members comprise a shape memory material, wherein the heat from the eye causes the penetrating members to move from the first unextended position to the second extended position.

39. The method of claim 30, wherein said implant comprises a deployment rod attached to said penetrating members, and wherein the step of causing said penetrating members to move from said first unextended position to said second extended position involves actuation of said deployment rod.

40. The method of claim 30, wherein said implant comprises a longitudinally flexible body, wherein each penetrating member comprises at least one penetrating tip, wherein each penetrating member further comprises at least one supporting arm connecting the penetrating tip to the longitudinally flexible body at a hinge, wherein said implant comprises a deployment rod attached to said penetrating members, and wherein the step of causing said penetrating members to move from said first unextended position to said second extended position involves actuation of said deployment rod.

41. The method of claim 40, wherein actuation of said deployment rod is performed by moving said deployment rod relative to said longitudinally flexible body.

42. The method of claim 30, wherein when said penetrating members are in said first unextended position, said penetrating members generally point in a proximal direction along the longitudinal axis of the implant, wherein advancing the implant in a distal direction does not cause said penetrating members to become extended, and wherein retracting the implant in a proximal direction back through the Schlemm'"'"'s Canal causes said penetrating members to move from the first unextended position to the second extended position.