OCULAR IMPLANT WITH SHAPE CHANGE CAPABILITIES

• US 20100137981A1
• Filed: 06/25/2009
• Published: 06/03/2010
• Est. Priority Date: 06/25/2008
• Status: Active Grant

• Current Assignee: Alcon Incorporated
• Original Assignee: Transcend Medical Incorporated (Alcon Incorporated)
• Inventors: Garcia, Jose, Silvestrini, Thomas A., John, Steven, Lilly, Richard S.
• Granted Patent: US 8,617,139 B2
• Time in Patent Office: Days
• US Class Current: 623/4.100
• 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 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04

Abstract

Disclosed are devices, methods and systems for treatment of eye disease such as glaucoma. Implants are described herein that enhance aqueous flow through the normal outflow system of the eye with minimal to no complications. The implant can be reversibly deformed to a first shape, such as a generally linear shape conducive to insertion. Upon insertion, the implant can deform to a second shape, such as a generally non-linear shape conducive to retention within the eye. The shape also improves fluid flow from the anterior chamber and prevents or reduces clogging.

Claims

1. An ocular implant, comprising:

an elongate member having a flow pathway, at least one inflow port communicating with the flow pathway, and an outflow port communicating with the flow pathway, wherein the elongate member includes a first portion formed of a braided structure and adapted to transition between a first shape when in tension and a second shape upon release of tension, and a second portion formed at least partially of a non-braided structure;

wherein the elongate member is adapted to be positioned in the eye such that the inflow port communicates with the anterior chamber and the outflow port communicates with the suprachoroidal space.

2. An implant as in claim 1, wherein the first portion is adapted to transition from the first shape to the second shape while the second portion remains unchanged in shape.

3. An implant as in claim 1, wherein the second portion is overlayed with a braided structure.

4. An implant as in claim 1, wherein the elongate member includes a third portion formed of a non-braided structure.

5. An implant as in claim 1, wherein the first portion is positioned between the second and third portions.

6. An implant as in claim 1, wherein the first portion transitions to a state of reduced diameter under tension and transitions to a state of enlarged diameter upon removal of tension.

7. An implant as in claim 1, wherein the flow pathway is an internal lumen that extends through at least one of the first and second portions.

8. An ocular implant, comprising:

an elongate member having a flow pathway, at least one inflow port communicating with the flow pathway, and an outflow port communicating with the flow pathway, wherein at least a portion of the elongate member is adapted to reversibly deform between a first shape and a second shape upon release of tension;

wherein the elongate member is adapted to be positioned in the eye such that the inflow port communicates with the anterior chamber and the outflow port communicates with the suprachoroidal space.

9. The implant of claim 8, wherein the first shape is generally linear.

10. The implant of claim 8, wherein the second shape is generally non-linear.

11. The implant of claim 8, wherein at least a portion of the elongate member is adapted to reversibly deform at body temperature.

12. The implant of claim 8, wherein the portion of the elongate member adapted to reversibly deform is comprised of a thermoplastic elastomer material.

13. The implant of claim 8, further comprising a collar near the inflow port of the elongate member.

14. The implant of claim 8, further comprising at least a second outflow port communicating with the flow pathway.

15. A method of implanting an ocular device into the eye, comprising:

forming an incision in the cornea of the eye;

inserting an implant through the incision into the anterior chamber of the eye while the implant is under tension wherein the tension maintains the implant in a first shape and wherein the implant has a fluid passageway;

passing the implant along a pathway from the anterior chamber into the suprachoroidal space;

positioning the implant in a first position such that a first portion of the fluid passageway communicates with the anterior chamber and a second portion of the fluid passageway communicates with the suprachoroidal space to provide a fluid passageway between the suprachoroidal space and the anterior chamber; and

releasing the implant from tension wherein the release of tension permits the implant to transition to a second shape.

16. A method as in claim 15, wherein the implant is at least partially formed of a braided structure.

17. A method as in claim 15, wherein the implant includes a proximal section, a central section, and a distal section, and wherein the proximal section is formed of a solid tube that is overlayed with a braided structure, the central section is formed entirely of a braided structure, and the distal section is formed of a solid tube that is overlayed with a braided structure.

18. A method as in claim 15, further comprising mounting the implant on a delivery wire of a delivery device such that the delivery wire exerts a distal-directed force on a distal section of the implant while a sheath holds a proximal section of the implant to maintain the implant in tension.

19. A method as in claim 15, comprising releasing the implant from tension after positioning the implant in the first position.

20. A method as in claim 15, comprising releasing the implant from tension prior to positioning the implant in the first position.

21. A method as in claim 15, wherein the fluid passageway comprises an internal lumen that extends through the implant.

22. A method as in claim 15, wherein the at least a portion of the implant is larger when the implant is in the second shape than when the implant is in the first shape.

23. A method as in claim 18, wherein a portion of the delivery wire forms the incision by puncturing the cornea.

24. A method as in claim 15, wherein a distal end of the implant forms the incision by puncturing the cornea.

25. A method as in claim 15, further comprising passing the implant along the pathway through the eye until a decrease in resistance to passage is sensed.

26. A method as in claim 15, wherein a distal end of the implant has a spade shape, and further comprising creating a dissection plane in the tissue plane between the choroid and the sclera using the distal end of the implant.

27. A method as in claim 15, wherein passing the implant along a pathway from the anterior chamber into the suprachoroidal space comprises contacting the scleral spur and sliding the implant just below the scleral spur into the suprachoroidal space.

28. A method of implanting an ocular device into the eye, comprising:

forming an incision in the cornea of the eye;

loading on a delivery wire of a delivery device an implant having a fluid passageway, wherein the delivery wire is adapted to impose tension to deform at least a portion of the implant from a first shape conducive to retention within the suprachoroidal space into a second shape conducive to delivery;

inserting the implant loaded on the delivery wire through the incision into the anterior chamber of the eye;

passing the implant along a pathway from the anterior chamber into the suprachoroidal space;

positioning the implant in a first position such that a first portion of the fluid passageway communicates with the anterior chamber and a second portion of the fluid passageway communicates with the suprachoroidal space to provide a fluid passageway between the suprachoroidal space and the anterior chamber; and

releasing the implant from the delivery device wherein the release removes the tension and permits at least a portion of the implant to return to the first shape conducive to retention within the suprachoroidal space.

29. A method as in claim 28, wherein the second shape conducive to delivery comprises a generally linear shape.

30. A method as in claim 28, wherein the first shape conducive to retention is a generally non-linear shape.

31. A method as in claim 28, wherein a portion of the delivery wire forms the incision by puncturing the cornea.

32. A method as in claim 28, wherein a distal end of the implant forms the incision by puncturing the cornea.

33. A method as in claim 28, wherein passing the implant along a pathway from the anterior chamber into the suprachoroidal space comprises contacting the scleral spur and sliding the implant just below the scleral spur into the suprachoroidal space.

34. A system for treating an ocular disorder in a patient, comprising:

an elongate member having a flow pathway, at least one inflow port communicating with the flow pathway, and an outflow port communicating with the flow pathway, wherein the elongate member includes a first portion formed of a braided structure and adapted to transition between a first shape when in tension and a second shape upon release of tension, and a second portion formed at least partially of a non-braided structure, wherein the elongate member is adapted to be positioned in the eye such that the inflow port communicates with the anterior chamber and the outflow port communicates with the suprachoroidal space; and

a delivery device having a delivery component that removably attaches to the elongate member, wherein the delivery component is adapted to maintain the elongate member in tension.

35. A system as in claim 34, wherein the delivery component comprises a delivery wire and a sheath, wherein the delivery wire can exert a distally-directed force against a distal portion of the elongate member while the sheath holds a proximal portion of the elongate member to maintain the elongate member in tension.

36. A system as in claim 34, wherein the delivery wire has a sharpened distal tip.

37. A system as in claim 34, wherein the delivery component has a sharpened distal tip.

38. A system as in claim 34, wherein the delivery component has a blunt distal tip.

39. A system as in claim 34, wherein at least a portion of the delivery component inserts into an internal lumen of the elongate member.

40. A system as in claim 34, wherein at least a portion of the delivery component fits over the elongate member.

41. A system for treating an ocular disorder in a patient, comprising:

an elongate member having a flow pathway, at least one inflow port communicating with the flow pathway, and an outflow port communicating with the flow pathway, wherein at least a portion of the elongate member is adapted to reversibly deform between a first shape and a second shape, wherein the elongate member is adapted to be positioned in the eye such that the inflow port communicates with the anterior chamber and the outflow port communicates with the suprachoroidal space; and

a delivery device having a delivery component that removably couples to the elongate member, wherein the delivery component is adapted to deform at least a portion of the elongate member into the first shape by imposing tension.

42. A system as in claim 41, wherein the delivery component imposes tension on at least a portion of the elongate member by extending through the elongate member.

43. A system as in claim 41, wherein the delivery wire has a sharpened distal tip.

44. A system as in claim 41, wherein the elongate member has a sharpened distal tip.

45. A system as in claim 41, wherein the elongate member has a blunt distal tip.

46. A system as in claim 41, wherein at least a portion of the delivery component inserts into an internal lumen of the elongate member.

47. A system as in claim 41, wherein the first shape is generally linear.

48. A system as in claim 42, wherein removing the delivery component extending through the elongate member releases the tension imposed on at least a portion of the elongate member.

49. A system as in claim 48, wherein the second shape is generally non-linear.