Ocular Implant Delivery System and Method

• US 20090132040A1
• Filed: 11/20/2007
• Published: 05/21/2009
• Est. Priority Date: 11/20/2007
• Status: Active Grant

• Current Assignee: Alcon Incorporated
• Original Assignee: Ivantis Inc.
• Inventors: Feehan, Diane, Schieber, Andrew T., Zenz-Olson, Nathaniel, Euteneuer, Charles L., Matthees, Edward, McCarville, Rebecca, Frion, Duane
• Granted Patent: US 8,512,404 B2
• Time in Patent Office: Days
• US Class Current: 623/6.120
• 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 of inserting an ocular implant into a patient'"'"'s eye, the ocular implant being mounted on a carrier, the method comprising: inserting a cannula into an anterior chamber of the eye; moving a distal exit port of the cannula into communication with Schlemm'"'"'s canal; and advancing the ocular implant and carrier through an exit port of the cannula into Schlemm'"'"'s canal. The invention also provides an ocular implant and delivery system comprising: a cannula comprising a distal exit port adapted to be inserted into a Schlemm'"'"'s canal portion of an eye; an ocular implant; a carrier disposed within the implant and movable with the implant within the cannula; and a proximal control adapted to be operated from exterior to an eye to move at least one of the carrier and the implant when the distal exit port of the cannula is within the eye.

Claims

1. A method of inserting an ocular implant into a patient'"'"'s eye, the ocular implant being mounted on a carrier, the method comprising:

inserting a cannula into an anterior chamber of the eye;

moving a distal exit port of the cannula into communication with Schlemm'"'"'s canal; and

advancing the ocular implant and carrier through an exit port of the cannula into Schlemm'"'"'s canal.

2. The method of claim 1 wherein the ocular implant comprises a plurality of openings, the method further comprising advancing the ocular implant and carrier into Schlemm'"'"'s canal with the carrier blocking the implant openings.

3. The method of claim 1 wherein the inserting step comprises inserting the cannula through a cornea of the eye.

4. The method of claim 1 wherein the passing step comprises advancing the ocular implant with a handheld actuator disposed exterior to the eye.

5. The method of claim 1 wherein the advancing step comprises moving a blunt distal surface into Schlemm'"'"'s canal.

6. The method of claim 1 wherein the advancing step comprises extending the ocular implant 60°

-180°

around Schlemm'"'"'s canal.

7. The method of claim 1 further comprising rotating the implant within Schlemm'"'"'s canal.

8. The method of claim 1 further comprising disengaging the ocular implant from the carrier.

9. The method of claim 8 wherein the disengaging step comprises moving at least one of the carrier and the ocular implant with respect to the other.

10. The method of claim 9 further comprising applying a distally directed force on the implant while applying a proximally directed force on the carrier.

11. The method of claim 10 wherein the step of applying a distally directed force comprises applying a distally directed force on the ocular implant with a pusher disposed in the cannula.

12. The method of claim 8 wherein the carrier comprises a reduced diameter portion, the disengaging step comprising orienting the ocular implant with respect to the reduced diameter portion of the carrier.

13. The method of claim 12 wherein the advancing step comprises advancing the ocular implant with a pusher comprising an implant engagement mechanism, the disengaging step comprising orienting the ocular implant and an implant engagement mechanism of the pusher with respect to the reduced diameter portion of the carrier.

14. The method of claim 1 further comprising removing the carrier from the eye.

15. The method of claim 1 further comprising ceasing advancement of the implant into Schlemm'"'"'s canal when a proximal portion of the implant remains in the anterior chamber and a distal portion of the implant lies in Schlemm'"'"'s canal.

16. The method of claim 1 further comprising delivering material through the carrier into Schlemm'"'"'s canal.

17. An ocular implant and delivery system comprising:

a cannula comprising a distal exit port adapted to be inserted into a Schlemm'"'"'s canal portion of an eye;

an ocular implant;

a carrier disposed within the implant and movable with the implant within the cannula; and

a proximal control adapted to be operated from exterior to an eye to move at least one of the carrier and the implant when the distal exit port of the cannula is within the eye.

18. The system of claim 17 wherein the ocular implant comprises a plurality of openings and the carrier is oriented to block the openings.

19. The system of claim 17 wherein the ocular implant and carrier together comprise a blunt distal end.

20. The system of claim 17 wherein the cannula forms an arc of a circle.

21. The system of claim 20 wherein the cannula has a radius of curvature less than about 0.1 inches.

22. The system of claim 17 wherein the cannula further comprises a distal cutting portion.

23. The system of claim 17 wherein the cannula has a diameter less than about 0.03 inches.

24. The system of claim 17 wherein the carrier has a larger diameter portion and a smaller diameter portion, the ocular implant being engaged with the larger diameter portion of the carrier.

25. The system of claim 24 further comprising a pusher disposed within the cannula and engaged with the ocular implant, the pusher being operably connected to the proximal control.

26. The system of claim 25 wherein the pusher comprises an implant engagement mechanism adapted to hold an ocular implant during advancement out of the exit port of the cannula.

27. The system of claim 26 wherein the ocular implant is engaged with the implant engagement mechanism when the implant is disposed between the larger diameter portion of the carrier and the implant engagement mechanism, and the ocular implant is disengaged with the implant engagement mechanism when the implant is disposed between the smaller diameter portion of the carrier and the implant engagement mechanism.

28. The system of claim 17 wherein the carrier comprises a material delivery lumen in communication with a material inlet in the proximal control.

29. The system of claim 17 wherein the proximal control comprises a distal handle connected to the cannula and a proximal handle comprising a carrier movement actuator, the proximal handle and the distal handle being movable with respect to each other.

30. The system of claim 29 wherein the proximal handle further comprises an implant movement actuator.

31. A method of inserting an ocular implant into a patient'"'"'s eye comprising:

inserting a cannula into an anterior chamber of the eye;

moving a distal cutting portion of the cannula through trabecular meshwork into Schlemm'"'"'s canal until a cannula stop element engages the trabecular meshwork; and

passing the ocular implant through an exit port of the cannula into Schlemm'"'"'s canal after engaging the stop element with the trabecular meshwork.

32. The method of claim 31 wherein the inserting step comprises inserting the cannula through a cornea of the eye.

33. The method of claim 31 wherein the passing step comprises advancing the ocular implant with a handheld actuator disposed exterior to the eye.

34. The method of claim 31 wherein the passing step comprises moving a blunt distal surface into Schlemm'"'"'s canal.

35. The method of claim 31 wherein the passing step comprises extending the ocular implant 60°

-180°

around Schlemm'"'"'s canal.

36. The method of claim 31 further comprising rotating the implant within Schlemm'"'"'s canal.

37. The method of claim 31 further comprising maintaining forward pressure on the cannula and deforming at least a portion of the cannula during the passing step.

38. The method of claim 31 further comprising disengaging the ocular implant from a delivery tool.

39. The method of claim 38 wherein the delivery tool comprises a pusher, the passing step comprising advancing a distal portion of the ocular implant through the exit port of the cannula with the pusher.

40. The method of claim 31 wherein the passing step comprises advancing the implant into Schlemm'"'"'s canal over a carrier.

41. The method of claim 40 further comprising removing the carrier from the eye.

42. The method of claim 41 wherein the removing step comprises disengaging the ocular implant from the carrier.

43. The method of claim 40 further comprising delivering material through the carrier into Schlemm'"'"'s canal.

44. The method of claim 31 further comprising ceasing advancement of the implant into Schlemm'"'"'s canal when a proximal portion of the implant remains in the anterior chamber and a distal portion of the implant lies in Schlemm'"'"'s canal.

45. An ocular implant system comprising:

a cannula comprising;

an implant lumen;

a distal exit port;

a distal cutting portion at least partially defining the exit port; and

a stop element limiting passage of the distal cutting portion into an anatomical lumen at a point in which the exit port is within the lumen; and

a proximal control adapted to be operated from exterior to an eye when the distal exit port of the cannula is within the eye.

46. The system of claim 45 wherein the cannula forms an arc of a circle.

47. The system of claim 46 wherein the cannula has a radius of curvature less than about 0.1 inches.

48. The system of claim 45 wherein the cutting portion comprises a cutting edge angled with respect to a central axis of the cannula.

49. The system of claim 48 wherein the cutting edge is at an angle of between about 10 degrees and about 80 degrees with respect to the central axis.

50. The system of claim 48 wherein the stop element is disposed at a proximal extent of the cutting edge.

51. The system of claim 45 wherein the cannula has a diameter less than about 0.03 inches.

52. The system of claim 45 further comprising a carrier disposed within the cannula and adapted to support an implant and sized to pass through the exit port.

53. The system of claim 52 further comprising an ocular implant engaged with the carrier.

54. The system of claim 53 wherein the carrier has a larger diameter portion and a smaller diameter portion, the ocular implant being engaged with the larger diameter portion of the carrier.

55. The system of claim 52 wherein the carrier comprises a material delivery lumen.

56. The system of claim 45 further comprising a pusher disposed within the cannula and engaged with the ocular implant, the pusher being operably connected to the proximal control.

57. The system of claim 56 wherein the pusher comprises an implant engagement mechanism adapted to hold an ocular implant during advancement out of the exit port of the cannula.

58. The system of claim 45 wherein the proximal control comprises a distal handle connected to the cannula and a proximal handle comprising a carrier movement actuator, the proximal handle and the distal handle being movable with respect to each other.

59. The system of claim 58 wherein the proximal handle further comprises an implant movement actuator.