Shunt device and method for treating glaucoma

• US 20050090806A1
• Filed: 11/12/2004
• Published: 04/28/2005
• Est. Priority Date: 04/26/1999
• Status: Active Grant

• Current Assignee: Glaukos Corporation
• Original Assignee: GMP Vision Solutions, Inc.
• Inventors: Brown, Reay H., Lynch, Mary G.
• Granted Patent: US 7,850,637 B2
• Time in Patent Office: Days
• US Class Current: 604/523
• CPC Class Codes: A61F 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2230/0052 T-shaped
• 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
• CPC Class Codes: A61M 2210/0612 Eyes
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable

Abstract

Shunt devices and a method for continuously decompressing elevated intraocular pressure in eyes affected by glaucoma by diverting excess aqueous humor from the anterior chamber of the eye into Schlemm'"'"'s canal where post-operative patency can be maintained with an indwelling shunt device which surgically connects the canal with the anterior chamber. The shunt devices provide uni- or bi-directional flow of aqueous humor into Schlemm'"'"'s canal.

Claims

1-48. -48. (canceled)

49. An ocular device comprising:

a body for implantation into Schlemm'"'"'s canal of a living eye comprising a portion for insertion into the canal, and a portion sized to extend from a position within the canal to a position within an anterior chamber of the eye; and

wherein the body is configured and dimensioned such that implantation of the body in living tissue of the canal permits dynamic flow of aqueous humor toward an episcleral venous system of the eye; and

wherein the device comprises a therapeutic agent.

50. The ocular device of claim 49, wherein the body is configured and dimensioned to permit dynamic flow of aqueous humor at a flow rate below about 2.5 microliters per minute.

51. The ocular device of claim 49, wherein tubular body is configured and dimensioned to permit dynamic flow of aqueous humor at a flow rate sufficient to maintain intraocular pressure above 6.0 mmHg.

52. The ocular device of claim 49, wherein tubular body is configured and dimensioned to permit dynamic flow of aqueous humor at a flow rate that maintains intraocular pressure between 15 mmHg and 21 mmHg.

53. The ocular device of claim 49, wherein a portion of the body for insertion into Schlemm'"'"'s canal is flexible, and the flexible portion is adapted to conform to a radius of curvature of about 6 mm.

54. The ocular device of claim 49, wherein the body comprises a substantially tubular body comprising open ends, and wherein the tubular body defines an aqueous humor directing channel extending between ends of the tubular body that is sized to permit flow of aqueous humor therein.

55. The ocular device of claim 54, wherein the tubular body comprises first and second integrally formed sections disposed transverse to each other.

56. The ocular device of claim 54, wherein the tubular body has an inner diameter of between 0.1 mm and 0.5 mm.

57. The ocular device of claim 54, wherein the tubular body defines an aqueous humor directing channel with a maximum width between 0.2 mm and 0.5 mm.

58. The ocular device of claim 54, wherein the tubular body further comprises an anchor portion for stabilizing the tubular body in Schlemm'"'"'s canal.

59. The ocular device of claim 54, wherein the tubular body comprises an arcuate outer surface.

60. The ocular device of claim 54, wherein the tubular body comprises a cylindrical outer cross-section.

61. The ocular device of claim 54, wherein the tubular body is curved.

62. The ocular device of claim 49, wherein the device further comprises a unidirectional valve.

63. The ocular device of claim 49, wherein at least a portion of the device comprises a solid material.

64. The ocular device of claim 63, wherein a portion of the device for insertion into Schlemm'"'"'s canal comprises a solid material.

65. The ocular device of claim 63, wherein a portion of the device for positioning within the anterior chamber comprises a solid material.

66. The ocular device of claim 63, wherein the solid material is porous.

67. The ocular device of claim 49 or 63, wherein the device comprises a V-shape.

68. The ocular device of claim 67, wherein the aqueous humor is directed in a unidirectional manner within Schlemm'"'"'s canal.

69. The ocular device of claim 67, wherein the portion of the device for insertion into Schlemm'"'"'s canal comprises an opening adjacent to a junction with the portion for positioning within the anterior chamber, to facilitate bi-directional flow of fluid within Schlemm'"'"'s canal.

70. The ocular device of claim 49 or 63, wherein the device comprises a T-shape.

71. The ocular device of claim 70, wherein one portion of the T-shaped device inserts into the anterior chamber of the eye, and two portions of the device insert within Schlemm'"'"'s canal in a substantially bi-directional manner.

72. The ocular device of claim 71, wherein the portion for insertion within Schlemm'"'"'s canal comprises a lumen therethrough that directs the passage of fluid into Schlemm'"'"'s canal.

73. The ocular device of claim 71, wherein the portion for insertion within the anterior chamber has a lumen therethrough that facilitates the passage of fluid into the portion of the device that is inserted within Schlemm'"'"'s canal.

74. The ocular device of claim 71, wherein the portion for insertion within the anterior chamber has two lumens therethrough that facilitate the passage of fluid into the portion of the device that is inserted within Schlemm'"'"'s canal in opposite directions within Schlemm'"'"'s canal.

75. An ocular device for use in a living eye having an anterior chamber and a Schlemm'"'"'s canal for relieving intraocular pressure by facilitating drainage from the anterior chamber of the living eye into Schlemm'"'"'s canal, the implant comprising:

a proximal portion in fluid communication with a distal portion, the proximal portion being sized and shaped to fit at least partially in the anterior chamber of the eye, and the distal portion being sized and shaped to fit at least partially in Schlemm'"'"'s canal of the eye;

wherein the device comprises a therapeutic agent.

76. The ocular device of claim 75, wherein the device further comprises an anchor portion for stabilizing the device within Schlemm'"'"'s canal.

77. The ocular device of claim 75, wherein the distal portion comprises an arcuate outer surface.

78. The ocular device of claim 75, wherein the device comprises a unidirectional valve.

79. The ocular device of claim 75, wherein the distal portion is flexible, and the flexible portion is adapted to conform to a radius of curvature of about 6 mm.

80. The ocular device of claim 75, wherein at least a portion of the device comprises a substantially tubular body comprising an open end.

81. The ocular device of claim 80, wherein the tubular body has an inner diameter of between 0.1 mm and 0.5 mm.

82. The ocular device of claim 80, wherein the tubular body defines an aqueous humor directing channel with a maximum width between 0.2 mm and 0.5 mm.

83. The ocular device of claim 80, wherein the tubular body comprises a cylindrical outer cross-section.

84. The ocular device of claim 80, wherein the tubular body is curved.

85. The ocular device of claim 75, wherein at least a portion of the device comprises a solid material.

86. The ocular device of claim 85, wherein the distal portion of the device comprises a solid material.

87. The ocular device of claim 85, wherein the proximal portion comprises a solid material.

88. The ocular device of claim 85, wherein the solid material is porous.

89. The ocular device of claim 75 or 85, wherein the device comprises a V-shape.

90. The ocular device of claim 89, wherein the device directs aqueous humor in a unidirectional manner within Schlemm'"'"'s canal.

91. The ocular device of claim 89, wherein the distal portion of the device comprises an opening adjacent to a junction with the proximal portion, to facilitate bi-directional flow of fluid within Schlemm'"'"'s canal.

92. The ocular device of claim 75 or 85, wherein the device comprises a T-shape.

93. The ocular device of claim 92, wherein one portion of the T-shaped device inserts into the anterior chamber of the eye, and two portions of the device insert within Schlemm'"'"'s canal in a substantially bi-directional manner.

94. The ocular device of claim 92, wherein the portion for insertion within Schlemm'"'"'s canal comprises a lumen therethrough that directs the passage of fluid into Schlemm'"'"'s canal.

95. The ocular device of claim 92, wherein the portion for insertion within the anterior chamber has a lumen therethrough that facilitates the passage of fluid into the portion of the device that is inserted within Schlemm'"'"'s canal.

96. The ocular device of claim 92, wherein the portion for insertion within the anterior chamber has two lumens therethrough that facilitate the passage of fluid into the portion of the device that is inserted within Schlemm'"'"'s canal in opposite directions within Schlemm'"'"'s canal.