Methods and Apparatus for Treating Glaucoma

• US 20090227934A1
• Filed: 03/05/2009
• Published: 09/10/2009
• Est. Priority Date: 03/05/2008
• Status: Active Grant

• Current Assignee: Alcon Incorporated
• Original Assignee: Ivantis Inc.
• Inventors: Wardle, John, Schieber, Andrew T., Hektner, Thomas R., Euteneuer, Charles L.
• Granted Patent: US 8,267,882 B2
• Time in Patent Office: Days
• US Class Current: 604/8
• CPC Class Codes: A61F 2009/00885 for treating a particular disease
• CPC Class Codes: A61F 2009/00891 Glaucoma
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61F 9/007 Methods or devices for eye surgery
• CPC Class Codes: A61F 9/00781 Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment drainage implants in general A61M27/002
• CPC Class Codes: A61K 9/0051 Ocular inserts, ocular implants
• CPC Class Codes: A61M 2210/0612 Eyes
• CPC Class Codes: A61M 27/002 Implant devices for drainage of body fluids from one part of the body to another intraocular A61F9/00781; middle ear A61F11/202
• CPC Class Codes: Y10S 623/905 Eye
• CPC Class Codes: Y10S 623/906 Corneal

Abstract

An ocular implant for treating glaucoma is provided, which may include any number of features. More particularly, the present invention relates to implants that facilitate the transfer of fluid from within one area of the eye to another area of the eye. One feature of the implant is that it includes a proximal inlet portion and a distal inlet portion adapted to be inserted into the anterior chamber of the eye, and an intermediate portion adapted to be inserted into Schlemm'"'"'s canal. Another feature of the implant is that it can be biased to assume a predetermined shape to aid in placement within the eye.

Claims

1. A method of treating glaucoma in an eye of a patient, comprising:

positioning a proximal inlet portion of an implant in an anterior chamber of the eye;

positioning an intermediate portion of the implant in Schlemm'"'"'s canal;

positioning a distal inlet portion of the implant in the anterior chamber of the eye;

allowing aqueous humor to flow from the anterior chamber through the implant into Schlemm'"'"'s canal.

2. The method of claim 1 wherein the allowing step further comprises allowing aqueous humor to flow from the anterior chamber into the proximal and distal inlet portions, through the intermediate portion, and into Schlemm'"'"'s canal.

3. The method of claim 1 wherein aqueous humor flows into Schlemm'"'"'s canal through a plurality of openings in the implant.

4. The method of claim 1 wherein the proximal inlet portion is spaced approximately 60 to 180 degrees from the distal inlet portion.

5. The method of claim 1 wherein aqueous humor flows longitudinally along the implant.

6. The method of claim 5 wherein aqueous humor flows laterally across the implant.

7. A method of implanting a dual inlet ocular implant into an eye of a patient, comprising:

inserting a cannula into an anterior chamber of the eye so that a distal tip of the cannula is in communication with Schlemm'"'"'s canal;

inserting a distal inlet portion of the implant through the cannula into Schlemm'"'"'s canal;

advancing the implant distally along Schlemm'"'"'s canal until only a proximal inlet portion of the implant remains in the cannula;

introducing the distal inlet portion of the implant into the anterior chamber of the eye from Schlemm'"'"'s canal.

8. The method of claim 7 further comprising removing the cannula from the anterior chamber of the eye leaving the proximal inlet portion of the implant in the anterior chamber of the eye.

9. The method of claim 7 wherein the introducing step comprises:

advancing a tissue penetrating guide wire distally from the implant to penetrate into the anterior chamber of the eye from Schlemm'"'"'s canal;

advancing the implant over the guide wire to introduce the distal inlet portion of the implant into the anterior chamber of the eye from Schlemm'"'"'s canal.

10. The method of claim 7 wherein the introducing step comprises:

advancing a tissue penetrating guide wire distally from the implant to penetrate into the anterior chamber of the eye from Schlemm'"'"'s canal;

advancing the implant over the guide wire to introduce the distal inlet portion of the implant into the anterior chamber of the eye from Schlemm'"'"'s canal.

11. The method of claim 7 wherein the introducing step comprises:

making an incision from the anterior chamber of the eye into Schlemm'"'"'s canal at a position near the distal inlet portion of the implant;

allowing the distal inlet portion of the implant to assume a predetermined at rest shape which results in the distal inlet portion bending through the incision into the anterior chamber of the eye from Schlemm'"'"'s canal.

12. The method of claim 7 wherein the introducing step comprises:

making an incision from the anterior chamber into Schlemm'"'"'s canal at a position near the distal inlet portion of the implant;

allowing the distal inlet portion of the implant to assume a predetermined at rest shape which results in the distal inlet portion bending through the incision into the anterior chamber of the eye from Schlemm'"'"'s canal.

13. The method of claim 7 wherein the proximal inlet portion is spaced approximately 60 to 180 degrees from the distal inlet portion.

14. The method of claim 7 further comprising:

inserting a core into a lumen defined by the implant; and

inserting a guide wire into a guide wire lumen defined by the core.

15. The method of claim 14 wherein the core is disposed in the lumen defined by the implant while the implant is advanced distally along Schlemm'"'"'s canal.

16. The method of claim 14 wherein the guide wire is disposed in the guide wire lumen defined by the core while the implant is advanced distally along Schlemm'"'"'s canal.

17. The method of claim 14 wherein the introducing step comprises:

advancing a distal portion of the guide wire distally from the core to penetrate into the anterior chamber of the eye from Schlemm'"'"'s canal; and

advancing the implant off of the core and over the guide wire to introduce the distal inlet portion of the implant into the anterior chamber of the eye from Schlemm'"'"'s canal.

18. The method of claim 17 wherein:

the distal portion of the guide wire is urged to assume a stressed shape when the distal portion of the guide wire is disposed in the guidewire lumen; and

the distal portion of the guide wire is free to assume a predetermined at rest shape when the distal portion of the guide wire is advanced distally from the core.

19. The method of claim 18 wherein the distal portion of the guide wire has a distal radius of curvature when the distal portion of the guide wire is free to assume the predetermined at rest shape.

20. The method of claim 19 wherein:

a proximal portion of the guide wire has a proximal radius of curvature; and

the proximal radius of curvature is generally greater than the distal radius of curvature.

21. The method of claim 19 wherein:

a proximal portion of the guide wire has a proximal radius of curvature different from the distal radius of curvature; and

the proximal radius of curvature approximates the curvature of Schlemm'"'"'s canal.

22. The method of claim 14, wherein the implant comprises a first material and the core comprises a second material different from the first material.

23. The method of claim 22, wherein the first material and the second material comprise materials which provide a relatively low friction interface when placed in sliding contact with one another.

24. The method of claim 23, wherein:

an interface between two samples of the first material has a first coefficient of friction;

an interface between a sample of the first material and a sample of the second material has a second coefficient of friction; and

the first coefficient of friction is greater than the second coefficient of friction.

25. The method of claim 22, wherein the first material and the second material comprise materials which are unlikely to gall when placed in sliding contact with one another.

26. The method of claim 22, wherein the first material comprises a metallic material and the second material comprises a polymeric material.

27. The method of claim 14, wherein the guide wire comprises a first material and the core comprises a second material different from the first material.

28. The method of claim 27, wherein the first material and the second material comprise materials which provide a relatively low friction interface when placed in sliding contact with one another.

29. The method of claim 28, wherein:

an interface between two samples of the first material has a first coefficient of friction;

an interface between a sample of the first material and a sample of the second material has a second coefficient of friction; and

the first coefficient of friction is greater than the second coefficient of friction.

30. The method of claim 27, wherein the first material and the second material comprise materials which are unlikely to gall when placed in sliding contact with one another.

31. The method of claim 27, wherein the first material comprises a metallic material and the second material comprises a polymeric material.

32. The method of claim 7, further comprising flushing the cannula with a fluid.

33. The method of claim 32, wherein the flushing is performed prior inserting a distal end of the cannula into the anterior chamber for preventing the introduction of air bubbles into the anterior chamber of the eye.

34. The method of claim 7, further comprising injecting a bolus of viscoelastic material proximate a target location in the anterior chamber of the eye.

35. The method of claim 34, further comprising piercing a wall of Schlemm'"'"'s canal with a distal end of the cannula at the target location.

36. The method of claim 35, wherein the bolus of viscoelastic material is injected prior to piercing the wall of Schlemm'"'"'s canal for precluding the formation of a pool of blood near the target location.

37. The method of claim 34, further comprising piercing a trebecular mesh of the eye with a distal end of the cannula at the target location.

38. The method of claim 7 wherein the introducing step comprises:

advancing a self-piercing distal inlet in a distal direction to cause the distal inlet to cut through Schlemm'"'"'s canal into the anterior chamber.

39. The method of claim 38 wherein the self-piercing distal inlet is advanced while the distal inlet portion is biased inwards.

40. An ocular implant defining a generally cylindrical volume, comprising:

a proximal inlet portion at a proximal end of the implant;

a distal inlet portion at a distal end of the implant, the distal inlet portion being biased to bend at a first radius of curvature;

an intermediate portion positioned between the proximal inlet portion and the distal inlet portion; and

a plurality of openings in the implant to facilitate fluidic flow laterally across the elongate implant.

41. The implant of claim 40 wherein the implant defines a lumen to facilitate fluidic flow longitudinally along the implant.

42. The implant of claim 40 wherein the intermediate portion is biased to bend at a second radius of curvature.

43. The implant of claim 42 wherein the first radius of curvature is smaller than the second radius of curvature.

44. The implant of claim 42 wherein the second radius of curvature approximates the curvature of Schlemm'"'"'s canal.

45. The implant of claim 42 wherein the proximal portion is biased to bend at a third radius of curvature.

46. The implant of claim 45 wherein the third radius of curvature is generally smaller than the second radius of curvature.

47. The implant of claim 45 wherein the third radius of curvature is generally equal to the first radius of curvature.

48. The implant of claim 40 wherein the plurality of openings extend over more than about 50% of an outer surface area of the implant.

49. An ocular implant defining a generally cylindrical volume, comprising:

a proximal inlet portion at a proximal end of the implant, the proximal inlet portion adapted to be positioned in an anterior chamber of the eye;

a distal inlet portion at a distal end of the implant, the distal inlet portion adapted to be positioned in the anterior chamber of the eye;

an intermediate portion positioned between the proximal and distal inlet portions, the intermediate portion adapted to be positioned in Schlemm'"'"'s canal; and

a plurality of openings in the implant to facilitate fluidic flow laterally across the implant.

50. The implant of claim 49 wherein the implant defines a lumen to facilitate fluidic flow longitudinally along the implant.

51. An assembly, comprising:

an ocular implant defining an implant lumen;

a core disposed in the implant lumen;

a guide wire disposed in a guide wire lumen defined by the core;

wherein the guide wire is biased to assume a predetermined at rest shape;

the guide wire having a distal radius of curvature and a proximal radius of curvature when the guide wire is assuming the predetermined at rest shape; and

wherein the proximal radius of curvature is greater than the distal radius of curvature.

52. The assembly of claim 51 wherein the proximal radius of curvature approximates the curvature of Schlemm'"'"'s canal.

53. The assembly of claim 51 wherein an intermediate portion of the ocular implant is biased to bend at a second radius of curvature.

54. The assembly of claim 53 wherein the proximal radius of curvature of the guide wire is generally equal to the second radius of curvature of the ocular implant.

55. The assembly of claim 51 wherein the ocular implant and the core urge the guide wire to assume a stressed shape that is different from the predetermined at rest shape.

56. The assembly of claim 55 wherein the stressed shape is generally straighter than the predetermined at rest shape.

57. The assembly of claim 51, wherein the implant comprises a first material and the core comprises a second material different from the first material.

58. The assembly of claim 57, wherein the first material and the second material comprise materials which provide a relatively low friction interface when placed in sliding contact with one another.

59. The assembly of claim 58, wherein:

an interface between two samples of the first material has a first coefficient of friction;

an interface between a sample of the first material and a sample of the second material has a second coefficient of friction; and

the first coefficient of friction is greater than the second coefficient of friction.

60. The assembly of claim 57, wherein the first material and the second material comprise materials which are unlikely to gall when placed in sliding contact with one another.

61. The assembly of claim 57, wherein the first material comprises a metallic material and the second material comprises a polymeric material.

62. The assembly of claim 51, wherein the guide wire comprises a first material and the core comprises a second material different from the first material.

63. The assembly of claim 62, wherein the first material and the second material comprise materials which provide a relatively low friction interface when placed in sliding contact with one another.

64. The assembly of claim 63, wherein:

an interface between two samples of the first material has a first coefficient of friction;

an interface between a sample of the first material and a sample of the second material has a second coefficient of friction; and

the first coefficient of friction is greater than the second coefficient of friction.

65. The assembly of claim 62, wherein the first material and the second material comprise materials which are unlikely to gall when placed in sliding contact with one another.

66. The assembly of claim 62, wherein the first material comprises a metallic material and the second material comprises a polymeric material.

67. The assembly of claim 51 further comprising a cannula disposed about the ocular implant.

68. The assembly of claim 67 further comprising a luer fitting disposed in fluid communication with a lumen defined by the cannula.

73. The device of claim 67 wherein the hatch assumes the second position when the core is withdrawn from the hatch lumen.

69. A device, comprising:

an ocular implant comprising a body and a hatch;

the body defining a body lumen and a longitudinal axis;

the hatch defining a hatch lumen having a hatch axis;

the hatch comprising an arm hingedly connecting the hatch to the body;

the hatch having a first position in which the hatch is generally coaxial with the body;

the hatch having a second position in which the hatch axis is skewed relative to the longitudinal axis of the body; and

wherein the hatch is biased to assume the second position.

70. The device of claim 69 wherein:

the hatch is disposed in the first position; and

the device further includes a core extending through the body lumen and the hatch lumen.

71. The device of claim 70 wherein at least a portion of the hatch extends around a portion of the core across a radial span of more than 180 degrees.

72. The device of claim 70 wherein the core causes the hatch to remain in the first position.

81. The implant of claim 70 wherein a wall of the implant defines a plurality of openings in the implant to facilitate fluidic flow laterally across the implant.

82. The implant of claim 70 wherein the implant defines a lumen to facilitate fluidic flow longitudinally along the implant.

74. An ocular implant, comprising:

a proximal locking portion at a proximal end of the implant;

a distal locking portion at a distal end of the implant;

an intermediate portion extending between the proximal locking portion and the distal locking portion;

the intermediate portion having a longitudinal axis that follows an arcuate path when the implant is assuming a relaxed shape;

wherein the proximal locking portion is biased to extend in a first radially inward direction relative to the arcuate path of the longitudinal axis of the intermediate portion; and

wherein the distal locking portion is biased to extend in a second radially inward direction relative to the arcuate path of the longitudinal axis of the intermediate portion.

75. The implant of claim 74 wherein the first radially inward direction and the second radially inward direction intersect one another.

76. The implant of claim 74 wherein the first radially inward direction and the second radially both lead out of Schlemm'"'"'s canal of an eye when the intermediate portion of the implant is disposed in Schlemm'"'"'s canal of the eye.

77. The implant of claim 74 wherein the implant is dimensioned so that the proximal locking portion and the distal locking portion will both extend through a wall of Schlemm'"'"'s canal of an eye when the intermediate portion of the implant is disposed in Schlemm'"'"'s canal of the eye.

78. The implant of claim 74 wherein the likelihood that the intermediate portion of the implant will migrate within Schlemm'"'"'s canal of an eye is reduced when the proximal locking portion and the distal locking portion both extend through a wall of Schlemm'"'"'s canal.

79. The implant of claim 74 wherein the first radially inward direction and the second radially both lead out of Schlemm'"'"'s canal of an eye when the longitudinal axis of the intermediate portion is coaxial with a longitudinal axis of Schlemm'"'"'s canal.

80. The implant of claim 74 wherein a radius of curvature of the longitudinal axis of the intermediate portion approximates the curvature of Schlemm'"'"'s canal when the implant is assuming the relaxed shape.

83. An ocular implant defining a generally cylindrical volume, comprising:

a proximal inlet portion at a proximal end of the implant, the proximal inlet portion adapted to be positioned in an anterior chamber of the eye;

a distal inlet portion at a distal end of the implant, the distal inlet portion adapted to be positioned in a suprachoroidal space of the eye;

an intermediate portion positioned between the proximal and distal inlet portions; and

a plurality of openings in the implant to facilitate fluidic flow laterally across the implant.

84. A method of treating glaucoma in an eye of a patient, comprising:

providing an ocular implant comprising a wall defining a lumen;

inserting a core into the lumen of the ocular implant;

advancing a distal end of a cannula through a cornea of the eye so that a distal portion of the cannula is disposed in an anterior chamber of the eye;

advancing the core and the ocular implant through a cannula lumen defined by the cannula; and

advancing a distal end the core and a distal end of the ocular implant between a choriod and a sclera of the eye.

85. The method of claim 84 further comprising piercing one or more ocular tissues with the distal end of the cannula.

86. The method of claim 85 wherein the one or more ocular tissues comprise ciliary body tissue.

87. The method of claim 85 wherein the one or more ocular tissues comprise trebecular meshwork tissue.

88. The method of claim 85 wherein the one or more ocular tissues comprise corneal tissue.

89. The method of claim 84 wherein the wall of the ocular implant defines a plurality of openings fluidly communicating with the lumen of the ocular implant.

90. The method of claim 89 wherein inserting the core into the lumen of the ocular implant substantially blocks the openings defined by the wall of the ocular implant.

91. The method of claim 89 wherein inserting the core into the lumen of the ocular implant substantially fills the lumen of the ocular implant.

92. The method of claim 84 further comprising inserting a guide wire into a guide wire lumen defined by the core.