UVEOSCLERAL DRAINAGE DEVICE

• US 20130131577A1
• Filed: 01/11/2013
• Published: 05/23/2013
• Est. Priority Date: 09/21/2009
• Status: Abandoned Application

• Current Assignee: OPKO Instrumentation, LLC (Opko Health, Inc.), Vidus Ocular, Inc. (Opko Health, Inc.), Yale University
• Original Assignee: OPKO Instrumentation, LLC (Opko Health, Inc.)
• Inventors: Bronstein, Ben, Warner, Nicholas Fish, Shields, M. Bruce, Battle, Juan B.
• Application Number:
  US13/739,888
• Publication Number:
  US 20130131577A1
• Time in Patent Office: Days
• US Class Current: 604/9
• CPC Class Codes: A61F 2002/009 for hindering or preventing attachment of biological tissue
• CPC Class Codes: A61F 2230/0002 Two-dimensional shapes, e.g. cross-sections
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61F 9/00781 Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment drainage implants in general A61M27/002

Abstract

An ophthalmic shunt implantable in an eye having an elongate body and a branched conduit for conducting aqueous humor from an anterior chamber of the eye to the suprachoroidal space of the eye and the subconjunctival space, and a plate extending from an upper surface of the elongate body.

Claims

1. An ophthalmic shunt, comprising:

an elongate body having a forward end, a spaced back end, an upper surface, and a lower surface;

an insertion head extending from the forward end of the elongate body and being continuous with the elongate body, the insertion head defining a shearing edge constructed and arranged for cutting eye tissue;

a conduit having a first end defined on the insertion head and a first branch extending through the elongate body from the forward end to the back end of the elongate body and a second branch extending through the elongate body to the upper surface of the elongate body;

a connector extending from the upper surface of the elongate body, the connector encompassing and lengthening the second branch, wherein the second branch forms a lumen within the connector;

a plate having an upper and a lower surface, the lower surface of the plate extending from the connector opposite the elongate body and the connector creating a space between the upper surface of the elongate body and the lower surface of the plate.

2. The shunt of claim 1, wherein the elongate body is configured to position at least a portion of the insertion head and the first end of the conduit through an incision formed by the shearing edge of the insertion head and capable of being in fluid communication with the anterior chamber of the eye.

3. The shunt of claim 1, wherein the elongate body has an arcuate shape along at least a portion of its length that is adapted to extend along the curvature of the sclera.

4. The shunt of claim 1, wherein the elongate body has a substantially fusiform cross-sectional shape.

5. The shunt of claim 1, wherein the plate extends beyond at least one edge of the elongate body.

6. The shunt of claim 1, wherein the plate has a shape selected from the group consisting of polygonal, rounded polygonal, circular, oval, and elliptical.

7. The shunt of claim 1, wherein the plate is contoured to cover at least a portion of the sclera.

8. The shunt of claim 1, wherein at least one axis of the plate has a diameter or width of greater than about 2 mm.

9. The shunt of claim 1, wherein at least one axis of the plate has a diameter or width of from about 3 mm to about 9 mm.

10. The shunt of claim 1, wherein at least one axis of the plate has a diameter or width of about 6 mm.

11. The shunt of claim 1, wherein the upper surface of the plate is convex.

12. The shunt of claim 11, wherein the convex upper surface of the plate has a curvature that is substantially similar to adjacent sclera when the shunt is implanted.

13. The shunt of claim 1, wherein the upper surface of the elongate body and the lower surface of the plate are arranged and spaced to receive a sclera of an eye.

14. The shunt of claim 1, wherein the lower surface of the plate is substantially flat.

15. The shunt of claim 1, wherein the lower surface of the plate is concave.

16. The shunt of claim 15, wherein the concave lower surface of the plate has a curvature that is steeper than adjacent sclera when the shunt is implanted such that a convex space is created between the sclera and the lower surface of the plate when the shunt is implanted.

17. The shunt of claim 1, wherein at least a portion of the lower surface of the plate is textured.

18. The shunt of claim 17, wherein the texture of the textured lower surface is selected from the group consisting of corrugations, fingers, bumps, concentric circles, portions of concentric circles, and combinations thereof.

19. The shunt of claim 1, wherein the upper surface of the plate is substantially co-planar with the lower surface of the elongate body.

20. The shunt of claim 1, wherein the upper surface of the plate is convex and the lower surface of plate is concave.

21. The shunt of claim 20, wherein the curvature of the convex upper surface and the curvature of the concave lower surface is substantially the same.

22. The shunt of claim 1, wherein the connector has a height of from about 0.5 mm to about 0.8 mm from the upper surface of the elongate body to the lower surface of the plate.

23. The shunt of claim 1, wherein the connector has a height of about 0.6 mm from the upper surface of the elongate body to the lower surface of the plate.

24. The shunt of claim 1, wherein a joint between the connector and the plate is at a midpoint of the plate.

25. The shunt of claim 1, wherein a joint between the connector and the plate is offset from a midpoint of the plate.

26. The shunt of claim 25, wherein the joint between the connector and the plate is offset toward an anterior portion of the plate.

27. The shunt of claim 25, wherein the joint between the connector and the plate is positioned such than an outer surface of the connector and an outer edge of the plate are separated by about 2 mm or more.

28. The shunt of claim 27, wherein the outer edge of the plate is defined on an anterior portion of the plate.

29. The shunt of claim 1, wherein the connector is separated from the back end of the elongate body by about 1 mm or more.

30. The shunt of claim 1, wherein at least a portion of the lumen of the connector comprises a flow regulator.

31. The shunt of claim 30, wherein the flow regulator is selected from the group consisting of a valve, a membrane, a porous material, a flap, and combinations thereof.

32. The shunt of claim 30, wherein the flow regulator is comprised of a biodegradable material, a non-biodegradable material, or a combination thereof.

33. The shunt of claim 1, wherein a second end of the second branch is defined on the upper surface of the plate.

34. The shunt of claim 33, wherein the upper surface of the plate further comprises a flow regulator position to regulate the flow of liquid through the second end of the conduit.

35. The shunt of claim 33, wherein the flow regulator is selected from the group consisting of a valve, a membrane, a porous material, a flap, and combinations thereof.

36. The shunt of claim 33, wherein the flow regulator is comprised of a biodegradable material, a non-biodegradable material, or a combination thereof.

37. The shunt of claim 1, wherein a second end of the second branch is defined on a portion of the connector.

38. The shunt of claims 37, wherein the second end of the second branch is positioned below the lower surface of the plate.

39. The shunt of claim 37, wherein the second end of the second branch comprises one or more openings in the connector perpendicular to the lumen.

40. The shunt of claim 37, wherein the upper surface of the plate is continuous such that no opening for the second branch is defined on the upper surface of the plate.

41. The shunt of claim 37, further comprising an aperture to the second branch defined on an upper surface of the plate.

42. The shunt of claim 41, wherein the aperture further comprises a flow regulator positioned to regulate the flow of liquid through the aperture.

43. The shunt of claim 42, wherein the flow regulator is selected from the group consisting of a valve, a membrane, a porous material, a flap, and combinations thereof.

44. The shunt of claim 43, wherein the membrane or the porous material can be at least partially removed by laser.

45. The shunt of claim 1, wherein the shunt is comprised of a material selected from the group consisting of biocompatible metals, gold, platinum, nickel, molybdenum, titanium, biocompatible metal alloys, biocompatible polymers, silicone, and combinations thereof.

46. The shunt of claim 45, wherein the elongate body comprises a material selected from the group consisting of rigid materials and semi-rigid materials.

47. The shunt of claim 1, wherein the plate comprises a flexible material.

48. The shunt of claim 47, wherein the plate is comprised of silicone.

49. The shunt of claim 47, wherein the plate is comprised of a flexible biocompatible polymer.

50. The shunt of claim 1, wherein the connector comprises a material selected from the group consisting of a flexible material, a semi-rigid material, a rigid material, and combinations thereof.

51. The shunt of claim 1, wherein the connector further comprises a suture encircling the connector and positioned and arranged to obstruct flow of fluid through the connector.

52. The shunt of claim 51, wherein the suture is selected from the group consisting of releasable sutures, biodegradable sutures, and combinations thereof.

53. The shunt of claim 1, further comprising one or more therapeutic agent.

54. The shunt of claim 53, where the therapeutic agent is selected from the group consisting of steroids, beta blockers, alpha-2 antagonists, carbonic anhydride inhibitors, prostaglandin analogues, anti-fibrotic agents, anti-inflammatory agents, antimicrobial agents, and combinations thereof.

55. The shunt of claim 53, wherein the one or more therapeutic agents are contained within the conduit, the first branch, the second branch, or combinations thereof.

56. The shunt of claim 53, wherein the one or more therapeutic agents are coated on outer or inner surfaces of the elongate body, coated on outer or inner surfaces of the insertion head, coated on outer or inner surfaces of the connector, coated on outer or inner surfaces of the plate, or combinations thereof.

57. A method for treating glaucoma in an eye comprising:

inserting at least a portion of a first end of a biocompatible ophthalmic shunt through the sclera and suprachoroidal space into the anterior chamber of an eye such that at least a portion of the first end is in fluid communication with the anterior chamber of the eye;

positioning a second portion of the shunt into a suprachoroidal space of the eye such that at least a portion the second portion of the shunt is in fluid communication with the suprachoroidal space; and

positioning a third portion of the shunt into the subconjunctival space of the eye such that at least a portion of the third portion of the shunt is in communication with the subconjunctival space.

58. The method of claim 57, wherein the first end, the second portion, and the third portion are connected by a branched conduit.

59. The method of claim 57, wherein flow of fluid through the third portion of the shunt is at least partially obstructed when the third portion is initially positioned.

60. The method of claim 57, further comprising removing the obstruction when flow of fluid through the second portion becomes blocked.

61. The method of claim 57, further comprising removing the obstruction when pressure within the anterior chamber of the eye is insufficiently reduced to effect treatment.

62. The method of claim 57, further comprising applying a suture to the third portion of the shunt to obstruct flow of fluid through the third portion of the shunt.

63. The method of claim 62, wherein the suture is selected from the group consisting of releasable sutures and biodegradable sutures.

64. The method of claim 62, further comprising releasing the suture when flow of fluid through the second portion becomes blocked.

65. The method of claim 62, further comprising releasing the suture when pressure within the anterior chamber of the eye is insufficiently reduced to effect treatment.

66. The method of claim 57, wherein the shunt comprises a flow regulator selected from the group consisting of a membrane, a porous material, and combinations thereof, and wherein the method further comprises removing at least a portion of the membrane, porous material, or a combination thereof when flow of fluid through the second portion is insufficient to reduce to effect treatment.

67. The method of claim 66, wherein removing at least a portion of the membrane, porous material, or a combination thereof comprises applying a laser to the membrane, porous material or combination thereof.

68. The method of claim 57, wherein the shunt comprises a flow regulator selected from the group consisting of a valve, a flap or a combination thereof, and wherein the method further comprises opening the valve, flap, and combinations thereof when flow of fluid through the second portion is insufficient to effect treatment.