Ocular Pressure Regulation

• US 20070106236A1
• Filed: 12/22/2006
• Published: 05/10/2007
• Est. Priority Date: 11/14/2003
• Status: Active Grant

• Current Assignee: Alcon Incorporated
• Original Assignee: Transcend Medical Incorporated (Alcon Incorporated)
• Inventors: Coroneo, Minas
• Granted Patent: US 8,128,588 B2
• Time in Patent Office: Days
• US Class Current: 604/294
• CPC Class Codes: A61F 2/148 Implantation instruments specially adapted therefor
• CPC Class Codes: A61F 9/00781 Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment drainage implants in general A61M27/002

Abstract

This invention comprises a flexible ocular device for implantation into the eye formed of a biocompatible elastomeric material, foldable to a diameter of 1.5 mm or less, comprising a fluid drainage tube having at one end a foldable plate adapted to locate the device on the inner surface of the sclera in a suprachoroidal space formed by cyclodialysis, said drainage tube opening onto the disc at one end and opening to the anterior chamber when implanted into the eye at its other end, so as to provide aqueous pressure regulation. Also provided are methods for the treatment of glaucoma utilising the flexible ocular device, and an ocular pressure spike shunt.

Claims

1. An ocular device for implantation into the eye, comprising:

a fluid drainage tube having at a first end an anchor member adapted to be deployed within a suprachoroidal space on an inner surface of the sclera so as to locate the first end of the device on an inner surface of the sclera, wherein the first end of the drainage tube opens into the suprachoroidal space and a second end of the drainage tube opens into the anterior chamber when implanted into the eye, so as to provide aqueous pressure regulation.

2. The device of claim 1, wherein the anchor member is a disc.

3. The device of claim 1, wherein the device is formed of a biocompatible elastomeric material.

4. The device of claim 1, wherein the device is foldable to a diameter of 1.5 mm or less.

5. The device of claim 1, further comprising a valve coupled to the drainage tube.

6. The device of claim 1, wherein the anchor is rectangular.

7. The device of claim 1, wherein the anchor member has a diameter between approximately 0.05 mm to 6 mm.

8. The device of claim 1, wherein the anchor member has a thickness of 12.5 microns to 250 microns.

9. The device of claim 1, wherein the tube has an external diameter of 1 mm or less.

10. The device of claim 1, wherein the anchor member is approximately 3 mm in length when in a deployed state.

11. The device of claim 1, wherein the tube has a length of less than 4 mm.

12. An ocular device for implantation into the eye, comprising:

a fluid drainage tube having at a first end an anchor member adapted to be deployed within a suprachoroidal space on an inner surface of the sclera so as to locate the first end of the device on an inner surface of the sclera, wherein the first end of the drainage tube opens into the suprachoroidal space and a second end of the drainage tube opens into the anterior chamber when implanted into the eye, so as to provide aqueous pressure regulation, said fluid drainage tube being adapted for insertion through a self-sealing incision in the cornea and sized such that it cannot fall through the opening through which it is introduced into the suprachoroidal space.

13. The device of claim 12, wherein the anchor member is a disc.

14. The device of claim 12, wherein the device is formed of a biocompatible elastomeric material.

15. The device of claim 12, wherein the device is foldable to a diameter of 1.5 mm or less.

16. The device of claim 12, further comprising a valve coupled to the drainage tube.

17. The device of claim 12, wherein the anchor is rectangular.

18. The device of claim 12, wherein the anchor member has a diameter between approximately 0.05 mm to 6 mm.

19. The device of claim 12, wherein the anchor member has a thickness of 12.5 microns to 250 microns.

20. The device of claim 12, wherein the tube has an external diameter of 1 mm or less.

21. The device of claim 12, wherein the anchor member is approximately 3 mm in length when in a deployed state.

22. The device of claim 12, wherein the tube has a length of less than 4 mm.

23. The device of claim 12, wherein at least a portion of the device has a curvature that matches the curvature of the eye.

24. The device of claim 23, wherein the anchor member has a curvature that matches the curvature of the eye.

25. An ocular device for implantation into the eye, comprising:

a fluid drainage tube having at a first end an anchor member adapted to be deployed within a suprachoroidal space on an inner surface of the sclera so as to locate the first end of the device on an inner surface of the sclera, wherein the first end of the drainage tube opens into the suprachoroidal space and a second end of the drainage tube opens into the anterior chamber when implanted into the eye, so as to provide aqueous pressure regulation, wherein the anchor member has a curvature that matches the curvature of the eye.

26. The device of claim 25, wherein the anchor member transitions from a folded state to an unfolded state and wherein the curvature of the anchor member matches the curvature of the eye in the unfolded state.

27. The device of claim 25, wherein the anchor member is a disc.

28. The device of claim 25, wherein the device is formed of a biocompatible elastomeric material.

29. The device of claim 25, wherein the device is foldable to a diameter of 1.5 mm or less.

30. The device of claim 25, further comprising a valve coupled to the drainage tube.

31. The device of claim 25, wherein the anchor is rectangular.

32. The device of claim 25, wherein the anchor member has a diameter between approximately 0.05 mm to 6 mm.

33. The device of claim 25, wherein the anchor member has a thickness of 12.5 microns to 250 microns.

34. The device of claim 25, wherein the tube has an external diameter of 1 mm or less.

35. The device of claim 25, wherein the anchor member is approximately 3 mm in length when in a deployed state.

36. The device of claim 25, wherein the tube has a length of less than 4 mm.

37. An ocular device for implantation into the eye, comprising:

a fluid drainage tube having at a first end an anchor member adapted to be deployed within a suprachoroidal space on an inner surface of the sclera so as to locate the first end of the device on an inner surface of the sclera, wherein the first end of the drainage tube opens into the suprachoroidal space and a second end of the drainage tube opens into the anterior chamber when implanted into the eye, so as to provide aqueous pressure regulation, wherein the anchor is adapted to interact with the eye to keep the fluid drainage tube in a position that maintains a fluid passageway between the anterior chamber and the suprachoroidal space.

38. The device of claim 37, wherein the anchor has a curvature that matches the curvature of the eye.

39. The device of claim 37, wherein the device is formed of a biocompatible elastomeric material.

40. The device of claim 37, wherein the device is foldable to a diameter of 1.5 mm or less.

41. The device of claim 37, further comprising a valve coupled to the drainage tube.

42. The device of claim 37, wherein the anchor member has a diameter between approximately 0.05 mm to 6 mm.

43. The device of claim 37, wherein the anchor member has a thickness of 12.5 microns to 250 microns.

44. The device of claim 37, wherein the tube has an external diameter of 1 mm or less.

45. The device of claim 37, wherein the anchor member is approximately 3 mm in length when in a deployed state.

46. The device of claim 37, wherein the tube has a length of less than 4 mm.

47. The device of claim 37, wherein sutures are not required to hold the device in the eye.

48. The device of claim 37, wherein the device is manufactured of a material that is sufficiently soft so as to not erode choroid material when inserted into the eye.

49. An ocular implantation system, comprising:

an ocular instrument having a tip adapted to be placed into an angle between the iris and the cornea to create a space between the ciliary body and the sclera;

a fluid drainage tube adapted to be inserted into the eye via the ocular instrument, the fluid drainage tube adapted to be deployed within the space created by the ocular instrument tip so as to locate the first end of the device on an inner surface of the sclera, wherein a first end of the drainage tube opens into a suprachoroidal space and a second end of the drainage tube opens into the anterior chamber when implanted into the eye, so as to provide aqueous pressure regulation.

50. The device of claim 49, wherein an anchor is located on the first end of the fluid drainage tube, the anchor adapted to be deployed within the suprachoroidal space on the inner surface of the sclera.

51. The device of claim 49, wherein the ocular instrument is adapted to form a self-sealing incision in the cornea of the eye.

52. The device of claim 49, wherein sutures are not required to hold the device in the eye.

53. The device of claim 49, wherein the device is manufactured of a material that is sufficiently soft so as to not erode choroid material when inserted into the eye.

54. The device of claim 49, wherein the device is formed of a biocompatible elastomeric material.

55. The device of claim 49, wherein the device is foldable to a diameter of 1.5 mm or less.

56. The device of claim 50, wherein the anchor member has a diameter between approximately 0.05 mm to 6 mm.

57. The device of claim 50, wherein the anchor member has a thickness of 12.5 microns to 250 microns.

58. The device of claim 49, wherein the tube has an external diameter of 1 mm or less.

59. The device of claim 50, wherein the anchor member is approximately 3 mm in length when in a deployed state.

60. The device of claim 49, wherein the tube has a length of less than 4 mm.

61. The device of claim 49, wherein the ocular instrument is a cannula.