Method and apparatus for treatment of glaucoma

• US 20020026200A1
• Filed: 08/21/2001
• Published: 02/28/2002
• Est. Priority Date: 08/22/2000
• Status: Active Grant

• Current Assignee: James A. Savage
• Original Assignee: James A. Savage
• Inventors: Savage, James A.
• Granted Patent: US 6,699,211 B2
• Time in Patent Office: Days
• US Class Current: 606/108
• CPC Class Codes: A61F 9/00781 Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment drainage implants in general A61M27/002

Abstract

A new and improved method and apparatus for treating glaucoma is described herein. A device for directing aqueous humor from an anterior chamber to Schlemm'"'"'s canal comprises a seton, and may further comprise a pump operatively connected to the seton. The seton conducts aqueous directly from the anterior chamber to Schlemm'"'"'s canal so that it can drain directly into the aqueous veins leading to the venous circulation. The seton for lowering intraocular pressure of an associated eye comprises a first tube adapted to be inserted into an associated anterior chamber of the eye; and, two wing tubes extending from the first tube. The two wing tubes are adapted to be inserted into Schlemm'"'"'s canal. The two wing tubes and the first tube form a substantially continuous passageway, such that aqueous humor flows from the anterior chamber into Schlemm'"'"'s canal through the substantially continuous passageway.

Claims

1. A seton for lowering intraocular pressure of an associated eye, the seton comprising:

a first tube adapted to be inserted into an associated anterior chamber of the eye; and

,

at least two wing tubes extending from the first tube, the two wing tubes adapted to be inserted into an associated Schlemm'"'"'s canal, the two wing tubes and the first tube forming a substantially continuous passageway, such that associated aqueous humor flows from the anterior chamber into the Schlemm'"'"'s canal through the substantially continuous passageway.

2. The seton of claim 1, wherein the two wing tubes extend substantially perpendicular from the first tube.

3. The seton of claim 1, wherein the wing tubes have an outer diameter being no more than approximately 200 microns.

4. The seton of claim 1, wherein the two wing tubes are tapered.

5. The seton of claim 1, wherein each of the two wing tubes have an inner diameter ranging from approximately 80 microns to approximately 100 microns.

6. The seton of claim 1, wherein the first tube has an inner diameter ranging from approximately 280 microns to approximately 380 microns.

7. The seton of claim 1, wherein the first tube has an outer diameter ranging from approximately 580 microns to approximately 680 microns.

8. The seton of claim 1, wherein the first tube has a length of approximately 1.5 cm.

9. The seton of claim 1, wherein each of the two wing tubes has a length of approximately 1 cm.

10. The seton of claim 1, wherein the first tube and the two wing tubes are composed of a biologically inert material.

11. The seton of claim 10, wherein the biologically inert material is silicone.

12. The seton of claim 1, further comprising at least one tab attached to one of the wing tubes, the tab having a fixation hole defined therein for securing the seton.

13. The seton of claim 1, wherein the first tube and the two wing tubes form an intersection area, the intersection area having at least one port defined therein.

14. The seton of claim 13, wherein the port is adapted to be used for clearing obstructions in the seton.

15. The seton of claim 13, wherein the port is adapted to be used for measuring intraocular eye pressure.

17. The method of claim 16, wherein the seton further comprises at least one tab attached thereto, the tab having a hole defined therein.

18. The method of claim 17, further comprising the step of:

suturing the seton to an eye wall.

19. The method of claim 16, wherein the first tube and the two wing tubes form an intersection area, the intersection area further comprising a port defined therein.

20. The method of claim 19, further comprising the step of:

clearing obstructions, disposed in the wing tubes, through the port.

21. The method of claim 19, further comprising the step of:

monitoring aqueous outflow.

22. The method of claim 18, further comprising the step of:

measuring intraocular pressure through the port.

24. The device of claim 23, wherein the two wing tubes extend substantially perpendicular from the first tube.

25. The device of claim 23, wherein the wing tubes have an outer diameter being no more than approximately 200 microns.

26. The device of claim 23, wherein the two wing tubes are tapered.

27. The device of claim 23, wherein the two wing tubes have an inner diameter ranging from approximately 80 microns to approximately 100 microns.

28. The device of claim 23, wherein the first tube has an inner diameter ranging from approximately 280 microns to approximately 380 microns.

29. The device of claim 23, wherein the first tube has an outer diameter ranging from approximately 580 microns to approximately 680 microns.

30. The device of claim 23, wherein the first tube has a length of the first tube is approximately 1.5 cm.

31. The device of claim 23, wherein each of the two wing tubes has a length of approximately 1 cm.

32. The device of claim 23, wherein the first tube and the two wing tubes are composed of a biologically inert material.

33. The device of claim 32, wherein the biologically inert material is silicone.

34. The device of claim 23, further comprising at least one tab attached to one of the wing tubes, the tab having securing means for securing the seton to an associated eye wall.

35. The device of claim 23, wherein the first tube and the two wing tubes form an intersection area, the intersection area comprising at least one port defined therein.

36. The device of claim 35, wherein the port is adapted to be used for clearing obstructions in the seton.

37. The device of claim 35, wherein the port is adapted to be used for measuring intraocular eye pressure.

38. The device of claim 23, wherein the pump mechanism is adapted to draw the aqueous humor from the anterior chamber through the first tube and into the Schlemm'"'"'s canal.

39. The device of claim 23, wherein the first tube extends into the pump mechanism and the two wing tubes extend outwardly from the pump mechanism.

40. The device of claim 23, wherein the pump mechanism is implanted within an intrascleral dissection.

41. The device of claim 40, wherein the pump mechanism further comprises a power source operatively connected thereto.

42. The device of claim 41, wherein the power source is positioned in the intrascleral dissection.

43. The device of claim 41, wherein the power source is positioned between associated rectus muscles.

44. The device of claim 40, wherein the pump mechanism has length, width, and thickness dimensions of approximately 2 mm by approximately 2 mm by approximately 500 microns, respectively.

45. The device of claim 23, wherein the pump mechanism is implanted posterior to an associated limbus.

46. The device of claim 45, wherein the pump mechanism is implanted between associated rectus muscles.

47. The device of claim 45, wherein the pump mechanism has length, width, and thickness dimensions of approximately 6 mm, approximately 10 mm, and approximately 3 mm, respectively.

48. The device of claim 23, wherein the pump mechanism is adapted to operate on a demand basis, such that the required flow through the two wing tubes to achieve desired intraocular pressure varies according to diurnal fluctuation in aqueous production.

49. The device of claim 48, further comprising a feedback mechanism for monitoring work performed by the pump mechanism to achieve the desired intraocular pressure.

50. The device of claim 23, wherein the pump mechanism is adapted to be adjusted without having to surgically dissect tissues to expose a large portion of the pumping mechanism.

51. The device of claim 23, further comprising pressure reading means for transmitting intraocular pressure readings to a controller.

52. The device of claim 23, wherein the pump mechanism comprises a wafer.

53. The device of claim 52, wherein the wafer is surrounded by a microchip and an insulating protective layer.

63. The device of claim 23, wherein the pump mechanism is located on the surface of an associated eye.

64. The device of claim 46, wherein the pump mechanism further comprises a posterior surface, the posterior surface being concave.

65. The device of claim 46, wherein the pump mechanism further comprises a power source having a posterior surface, the posterior surface being concave.

16. A method for draining associated aqueous humor from an associated anterior chamber of an associated eye the eye having an associated sclera and an associated Schlemm'"'"'s canal, the method comprising the steps of:

providing a seton having a first tube and at least two wing tubes, the first tube adapted to be inserted into the anterior chamber of the eye, the two wing tubes extending from the first tube, the two wing tubes adapted to be inserted into the Schlemm'"'"'s canal, the two wing tubes and the first tube forming a substantially continuous passageway, wherein aqueous humor flows from the anterior chamber into Schlemm'"'"'s canal through the substantially continuous passageway;

dissecting the sclera to form a scleral flap and an intrascleral space;

cutting the Schlemm'"'"'s canal to provide cut ends;

inserting the first tube into the anterior chamber;

inserting the two wing tubes into the cut ends of the Schlemm'"'"'s canal;

covering the seton; and

,

draining the aqueous humor from the anterior chamber into Schlemm'"'"'s canal.

23. A device for directing associated aqueous humor from an associated anterior chamber to an associated Schlemm'"'"'s canal, the device comprising:

a seton, comprising;

a first tube adapted to be inserted into the anterior chamber; and

,

at least two wing tubes extending from the first tube, the two wing tubes adapted to be inserted into the Schlemm'"'"'s canal, the two wing tubes and the first tube forming a substantially continuous passageway, wherein the aqueous humor flows from the anterior chamber into the Schlemm'"'"'s canal through the substantially continuous passageway; and

,

a pump mechanism operatively connected to the seton.

54. A method of draining associated aqueous humor from an associated anterior chamber of an associated eye having an associated sclera, to an associated Schlemm'"'"'s canal, the method comprising the steps of:

providing a seton and a pumping mechanism operatively connected to the seton, the seton having a first tube and at least two wing tubes, the first tube adapted to be inserted into the associated anterior chamber of the associated eye, the two wing tubes extending from the first tube, the two wing tubes adapted to be inserted into the associated Schlemm'"'"'s canal, the two wing tubes and the first tube forming a substantially continuous passageway, such that the associated aqueous humor flows from the associated anterior chamber into the associated Schlemm'"'"'s canal through the substantially continuous passageway;

dissecting the associated sclera so as to form a scleral flap and an intrascleral space;

cutting the associated Schlemm'"'"'s canal to provide cut ends;

inserting the first tube into the associated anterior chamber;

inserting the two wing tubes into the cut ends of the associated Schlemm'"'"'s canal;

covering the seton;

activating the pumping mechanism; and

,

draining the associated aqueous humor from the associated anterior chamber to the associated Schlemm'"'"'s canal.

55. The method of claim 54, further comprising the step of:

implanting the pumping mechanism within the intrascleral dissection.

56. The method of claim 54, further comprising the step of:

implanting the pumping mechanism posterior to a limbus.

57. The method of claim 54, wherein the pumping mechanism is implanted posterior to a limbus between rectus muscles.

58. The method of claim 54, further comprising the steps of:

varying output from the pumping mechanism; and

obtaining desired intraocular pressure according to diurnal fluctuation in the associated aqueous humor production.

59. The method of claim 54, further comprising the step of:

decreasing output from the pumping mechanism when a predetermined intraocular pressure is reached.

60. The method of claim 54, further comprising the step of:

adjusting the pump output without having to surgically dissect tissues to expose a large portion of the pumping mechanism.

61. The method of claim 54, further comprising the step of:

providing intraocular pressure readings through telemetry.

62. A device for directing associated aqueous humor from an associated anterior chamber to an associated Schlemm'"'"'s canal, the device comprising:

a pump mechanism; and

,

a seton, comprising;

a first tube adapted to be inserted into the anterior chamber; and

,

a second tube extending from the pump mechanism, the second tube adapted to be inserted into the Schlemm'"'"'s canal, the tubes forming a substantially continuous passageway, wherein the aqueous humor flows from the anterior chamber into the Schlemm'"'"'s canal through the substantially continuous passageway, the second tube forming third and fourth tubes at an associated limbus.