Intraocular implants and methods and kits therefor

• US 8,287,482 B2
• Filed: 01/27/2010
• Issued: 10/16/2012
• Est. Priority Date: 06/26/2006
• Status: Active Grant

• Current Assignee: Sight Sciences, Inc.
• Original Assignee: Sight Sciences, Inc.
• Inventors: Badawi, David Y., Badawi, Paul
• Primary Examiner(s): DEAK, LESLIE R
• Application Number:
  US12/695,053
• Publication Number:
  US 20100191329A1
• Time in Patent Office: 993 Days
• Field of Search: 604/8, 604/9, 604/264, 623/23.64, 623/23.7
• US Class Current: 604/8
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• 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

Devices, methods and kits are described for reducing intraocular pressure. The devices include a support that is implantable within Schlemm'"'"'s canal and maintains the patency of the canal without substantially interfering with transmural fluid flow across the canal. The devices utilize the natural drainage process of the eye and can be implanted with minimal trauma to the eye. Kits include a support and an introducer for implanting the support within Schlemm'"'"'s canal. Methods include implanting a support within Schlemm'"'"'s canal, wherein the support is capable of maintaining the patency of the canal without substantial interference with transmural fluid flow across the canal.

Claims

1. A device comprising:

a support having at least one fenestration that is longitudinally insertable into a lumen of Schlemm'"'"'s canal, the support having a cross-sectional dimension sufficient to at least partially prop open Schlemm'"'"'s canal upon insertion into the canal, and to thereby maintain patency of at least a portion of the canal so that fluid may traverse the canal without substantial interference from the support,

wherein when the support is disposed within a lumen of Schlemm'"'"'s canal, contact between the support and a wall of the canal is discontinuous along a perimeter of the lumen of the canal, and wherein when the support is disposed within a cylindrical section of the lumen of the canal having an internal wall surface area C, the support contacts less than 30% of C.

2. The device of claim 1, wherein the support makes minimal contact with the interior surface of the canal wall when the support is disposed within the lumen of the canal.

3. The device of claim 1, wherein the support makes only tangential contact with the canal wall when the support is disposed within the lumen of the canal.

4. The device of claim 1, wherein the support makes only point contacts with the wall of the canal when the support is disposed within the lumen of the canal.

5. The device of claim 1, wherein the support comprises fluted edges.

6. The device of claim 5, wherein only outer peripheral edges of the support contact the canal wall when the support is disposed within the lumen of the canal.

7. The device of claim 1, wherein the support comprises elements that make periodic contact with the canal wall when the support is disposed within the lumen of the canal.

8. The device of claim 1, wherein the support comprises a biocompatible metal.

9. The device of claim 1, wherein the support comprises a biocompatible polymer.

10. The device of claim 1, wherein the support comprises a shape memory material.

11. The device of claim 10, wherein the support comprises a nickel titanium alloy.

12. The device of claim 10, wherein the support is compressible into a first configuration and expandable into a second configuration.

13. The device of claim 12, wherein the support is adapted to be thermally activated to be expanded into the second configuration.

14. The device of claim 1, wherein the support comprises a metal wire.

15. The device of claim 1, wherein the support has a unitary structure.

16. The device of claim 15, wherein the support has a sinusoidal or zig-zag configuration.

17. The device of claim 1, wherein the support has an open network structure.

18. The device of claim 1, wherein the support comprises multiple connected elements configured to be distributed longitudinally along Schlemm'"'"'s canal when the device is in use, and wherein at least one of the connected elements has a cross-sectional dimension sufficient to at least partially prop open Schlemm'"'"'s canal, and to thereby maintain patency of at least a portion of the canal.

19. The device of claim 18, wherein when the support is disposed within the lumen of Schlemm'"'"'s canal, at least one region of the support that is located between first and second adjacent connected elements does not contact the wall of the canal.

20. The device of claim 18, wherein at least one of the connected elements is ovoid.

21. The device of claim 18, wherein the at least one fenestration is included in at least one of the connected elements.

22. The device of claim 1, wherein the support is configured to be disposed entirely within Schlemm'"'"'s canal.

23. The device of claim 1, wherein at least a portion of the support is porous.

24. The device of claim 1, wherein the support contacts less than 10% of C.

25. The device of claim 1, wherein the support contacts less than 1% of C.

29. The device of claim 1, wherein the support occupies at least a portion of a central core of the canal.

30. The device of claim 1, wherein at least a portion of the support has a polyhedral shape.

31. The device of claim 1, wherein the support is non-tubular.

26. The device of 1, wherein the support comprises an active agent.

27. The device of claim 26, wherein the active agent comprises a prostaglandin.

28. The device of claim 26, wherein the active agent comprises a prostaglandin analog.

32. A device comprising:

a support having at least one fenestration that is longitudinally insertable into a lumen of Schlemm'"'"'s canal, the support comprising an exterior surface and having a cross-sectional dimension sufficient to at least partially prop open Schlemm'"'"'s canal upon insertion into the canal, and to thereby maintain patency of at least a portion of the canal so that fluid may traverse the canal without substantial interference from the support,

wherein when the support is disposed within a lumen of Schlemm'"'"'s canal, only a portion of the exterior surface of the support contacts an inner periphery of the lumen of the canal, and wherein when the support is disposed within a cylindrical section of the lumen of the canal having an internal wall surface area C, the support contacts less than 30% of C.

33. The device of claim 32, wherein the support makes minimal contact with the interior surface of the canal wall when the support is disposed within the lumen of the canal.

34. The device of claim 32, wherein the support makes only tangential contact with a wall of the canal when the support is disposed within the lumen of the canal.

35. The device of claim 32, wherein the support makes only point contacts with a wall of the canal when the support is disposed within the lumen of the canal.

36. The device of claim 32, wherein the support comprises fluted edges.

37. The device of claim 36, wherein only outer peripheral edges of the support contact the wall of the canal when the support is disposed within the lumen of the canal.

38. The device of claim 32, wherein the support comprises elements that make periodic contact with the canal wall when the support is disposed within the lumen of the canal.

39. The device of claim 32, wherein the support comprises a biocompatible metal.

40. The device of claim 32, wherein the support comprises a biocompatible polymer.

41. The device of claim 32, wherein the support comprises a shape memory material.

42. The device of claim 41, wherein the support comprises a nickel titanium alloy.

43. The device of claim 41, wherein the support is compressible into a first configuration and expandable into a second configuration.

44. The device of claim 43, wherein the support is adapted to be thermally activated to be expanded into the second configuration.

45. The device of claim 32, wherein the support comprises a metal wire.

46. The device of claim 32, wherein the support has a unitary structure.

47. The device of claim 46, wherein the support has a sinusoidal or zig-zag configuration.

48. The device of claim 32, wherein the support has an open network structure.

49. The device of claim 32, wherein the support comprises multiple connected elements configured to be distributed longitudinally along Schlemm'"'"'s canal when the device is in use, and wherein at least one of the connected elements has a cross-sectional dimension sufficient to at least partially prop open Schlemm'"'"'s canal, and to thereby maintain patency of at least a portion of the canal.

50. The device of claim 49, wherein when the support is disposed within the lumen of Schlemm'"'"'s canal, at least one region of the support that is located between first and second adjacent connected elements does not contact the wall of the canal.

51. The device of claim 49, wherein at least one of the connected elements is ovoid.

52. The device of claim 49, wherein the at least one fenestration is included in at least one of the connected elements.

53. The device of claim 32, wherein the support is configured to be disposed entirely within Schlemm'"'"'s canal.

54. The device of claim 32, wherein at least a portion of the support is porous.

55. The device of claim 32, wherein the support contacts less than 10% of C.

56. The device of claim 32, wherein the support contacts less than 1% of C.

60. The device of claim 32, wherein the support occupies at least a portion of a central core of the canal.

61. The device of claim 32, wherein at least a portion of the support has a polyhedral shape.

62. The device of claim 32, wherein the support is non-tubular.

57. The device of 32, wherein the support comprises an active agent.

58. The device of claim 57, wherein the active agent comprises a prostaglandin.

59. The device of claim 57, wherein the active agent comprises a prostaglandin analog.

63. A method for reducing intraocular pressure in an eye, the method comprising:

inserting a support having at least one fenestration into a lumen of Schlemm'"'"'s canal to at least partially prop open the canal and thereby maintain patency of at least a portion of the canal,

wherein when the support is disposed within the lumen of Schlemm'"'"'s canal, the support allows fluid to traverse the canal without substantial interference from the support, and wherein contact between the support and a wall of the canal is discontinuous along a perimeter of the lumen of the canal, and wherein when the support is disposed within a cylindrical section of the lumen of the canal having an internal wall surface area C, the support contacts less than 30% of C.

64. The method of claim 63, the method comprising inserting the support into the lumen of Schlemm'"'"'s canal such that the support is disposed entirely within the canal.

65. The method of claim 63, wherein the support makes minimal surface area contact with the canal wall when the support is disposed within the lumen of the canal.

66. The method of claim 63, wherein the support makes only tangential contact with the wall of the canal when the support is disposed within the lumen of the canal.

67. The method of claim 63, wherein the support makes only point contacts with the wall of the canal with the support is disposed within the lumen of the canal.

68. The method of claim 63, wherein the support comprises fluted edges that contact the wall of the canal.

69. The method of claim 63, wherein the support comprises elements that make periodic contact with the canal wall when the support is disposed within the lumen of the canal.

70. The method of claim 63, wherein the support has a unitary structure.

71. The method of claim 70, wherein the support has a sinusoidal or zig-zag structure.

72. The method of claim 63, wherein the support comprises a metal wire.

73. The method of claim 63, wherein the support comprises multiple connected elements distributed longitudinally along Schlemm'"'"'s canal when the support is disposed within the lumen of the canal, and wherein at least one of the elements has a cross-sectional dimension sufficient to at least partially prop open the canal to thereby maintain patency of at least a portion of the canal.

74. The method of claim 63, wherein the support contacts less than 10% of C.

75. The method of claim 63, wherein the support contacts less than 1% of C.

76. The method of claim 63, wherein the support has an open network structure.

77. The method of claim 63, wherein the support comprises a biocompatible metal.

78. The method of claim 63, wherein the support comprises a biocompatible polymer.

79. The method of claim 63, wherein the support comprises a shape memory material.

80. The method of claim 79, wherein the shape memory material comprises a nickel titanium alloy.

81. The method of claim 79, wherein the support is compressible into a first configuration and expandable into a second configuration.

82. The method of claim 79, wherein the support is adapted to be thermally activated to be expanded into the second configuration.

83. The method of claim 63, wherein the support delivers an active agent to the eye.

84. The method of claim 83, wherein the active agent comprises a prostaglandin.

85. The method of claim 83, wherein the active agent comprises a prostaglandin analog.

86. The method of claim 63, wherein the support occupies at least a portion of a central core of the canal.