Glaucoma Treatment Device

• US 20070191863A1
• Filed: 12/22/2006
• Published: 08/16/2007
• Est. Priority Date: 01/17/2006
• Status: Active Grant

• Current Assignee: Alcon Incorporated
• Original Assignee: Transcend Medical Incorporated (Alcon Incorporated)
• Inventors: Gifford, Hanson, Boyd, Stephen, Rosenman, Dan, Deem, Mark, De Juan, Eugene
• Granted Patent: US 8,721,656 B2
• Time in Patent Office: Days
• US Class Current: 606/108
• CPC Class Codes: A61B 34/70 Manipulators specially adapted for use in surgery
• CPC Class Codes: A61B 90/00 Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges protective face masks A41D13/11; surgeon's or patient's gowns or dresses A41D13/12; devices for carrying-off, for treatment of, or for carrying-over, body liquids A61M1/00
• CPC Class Codes: A61F 11/00 Methods or devices for treatment of the ears or hearing sense implantable prostheses that substitute or replace internal ear parts, e.g. ear-drums, A61F2/18; methods or devices to cause a change in the state of auditory consciousness A61M21/00; electrotherapy applying electrical stimulation of the auditory system, or circuits therefor A61N1/36; radiotherapy using optical stimulation of the auditory system A61N5/06; electro-acoustic hearing aids H04R25/00; Non-electric hearing aids; Methods or devices for enabling ear patients to achieve auditory perception through physiological senses other than hearing sense; Protective devices for the ears, carried on the body or in the hand headwear, e.g. caps or helmets, with means for protecting the ears A42B1/0188, A42B3/16
• CPC Class Codes: A61F 2/14 Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
• CPC Class Codes: A61F 2/142 Cornea, e.g. artificial corneae, keratoprostheses or corneal implants for repair of defective corneal tissue
• CPC Class Codes: A61F 2250/0001 Means for transferring electromagnetic energy to implants
• CPC Class Codes: A61F 2250/0096 Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
• CPC Class Codes: A61F 2250/0097 Visible markings, e.g. indicia
• CPC Class Codes: A61F 9/0008 Introducing ophthalmic products into the ocular cavity or retaining products therein putting in contact lenses A61F9/0061; introducing or retaining media in cavities of the body in general A61M31/00
• 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 9/00736 Instruments for removal of intra-ocular material or intra-ocular injection, e.g. cataract instruments A61F9/008 takes precedence
• 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: A61F 9/0133 Knives or scalpels specially adapted therefor
• CPC Class Codes: A61K 9/0051 Ocular inserts, ocular implants
• CPC Class Codes: A61M 2202/04 Liquids
• 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

Abstract

Methods and devices are adapted for implanting into the eye. An incision is formed in the cornea of the eye and a shunt is inserted through the incision into the anterior chamber of the eye. The shunt includes a fluid passageway. The shunt is passed along a pathway from the anterior chamber through the scleral spur of the eye into the suprachoroidal space and positioned in a first position such that a first portion of the fluid passageway communicates with the anterior chamber and a second portion of the fluid passageway communicates with the suprachoroidal space to provide a fluid passageway between the suprachoroidal space and the anterior chamber.

Claims

1. A method of implanting an ocular device into the eye, comprising:

forming an incision in the cornea of the eye;

inserting a shunt through the incision into the anterior chamber of the eye wherein the shunt includes a fluid passageway;

passing the shunt along a pathway from the anterior chamber through the scleral spur of the eye into the suprachoroidal space; and

positioning the shunt in a first position such that a first portion of the fluid passageway communicates with the anterior chamber and a second portion of the fluid passageway communicates with the suprachoroidal space to provide a fluid passageway between the suprachoroidal space and the anterior chamber.

2. A method as in claim 1, further comprising mounting the shunt on a delivery device and inserting the shunt through the incision while the shunt is mounted on the delivery device.

3. A method as in claim 2, wherein the shunt is mounted on a needle of the delivery device.

4. A method as in claim 2, further comprising pushing the shunt off the delivery device into the first position.

5. A method as in claim 2, further comprising:

positioning the shunt in the first position while the shunt is mounted on the delivery device; and

withdrawing the delivery device from the shunt while the shunt stays in the first position.

6. A method as in claim 2, wherein a portion of the delivery device forms the incision by puncturing the cornea.

7. A method as in claim 1, wherein a distal end of the shunt forms the incision by puncturing the cornea.

8. A method as in claim 1, further comprising advancing the shunt across the iris prior to passing the shunt through the scleral spur.

9. A method as in claim 1, further comprising using a guidewire to guide the shunt along the pathway.

10. A method as in claim 1, further comprising using a cannula to guide the shunt along the pathway.

11. A method as in claim 1, wherein the shunt has a curvature and further comprising positioning a distal end of the shunt at the scleral spur such that the curvature points toward the suprachoroidal space.

12. A method as in claim 1, wherein when in the first position at least 2 millimeters of the shunt is located in the anterior chamber.

13. A method as in claim 1, further comprising passing the shunt through the ciliary body.

14. A method as in claim 1, further comprising passing the shunt along the pathway through the ciliary body until a decrease in resistance to passage is sensed.

15. A method as in claim 1, wherein a distal end of the shunt has a spade shape, and further comprising creating a dissection plane in the tissue plane between the choroid and the sclera using the distal end of the shunt.

16. A method as in claim 1, further comprising using ultrasonic visualization while passing the shunt along the pathway.

17. A method as in claim 1, wherein the shunt includes a skirt that is located in the anterior chamber when the shunt is in the first position such that the skirt inhibits the shunt from passing further into the suprachoroidal space.

18. A method as in claim 1, further comprising positioning multiple shunts in the eye wherein each of the multiple shunts provide a fluid passageway between the suprachoroidal space and the anterior chamber.

19. A method as in claim 18, wherein the multiple shunts are located end-to-end in the eye such that the multiple shunts collectively provide a single fluid passageway between the suprachoroidal space and the anterior chamber.

20. A method as in claim 18, wherein the multiple shunts are interspersed in the eye such that each of the multiple shunts provides a separate fluid passageway between the suprachoroidal space and the anterior chamber.

21. A method as in claim 1, wherein a distal end of the shunt is passed through the incision followed by a proximal end of the shunt.

22. A method as in claim 1, wherein the incision is formed in the limbus of the cornea.

23. A method as in claim 22, wherein the incision is about 1 mm in size.

24. A method as in claim 22, wherein the incision is no greater than about 2.85 mm in size

25. A method as in claim 22, wherein the incision is no greater than about 2.85 mm and is greater than about 1.5 mm in size.

26. A method as in claim 1, wherein the shunt is in a state of reduced size during passage along the pathway and wherein the shunt transitions to an enlarged size when the shunt is in the first position.

27. A method as in claim 1, wherein the shunt is attached to an endoscope during passage along the pathway.

28. A method as in claim 27, wherein the endoscope is mounted to the side of the shunt.

29. A method as in claim 27, wherein the endoscope is co-axially positioned with the shunt.

30. A method as in claim 1, further comprising using a gonioscopy lens during delivery of the shunt into the eye.

31. A method as in claim 1, wherein the fluid passageway is an internal lumen in the shunt.

32. A method as in claim 1, wherein the fluid passageway is along an external surface of the shunt.

33. A method as in claim 1, wherein fluid flows through the fluid passageway via capillary action.

34. A method as in claim 1, forming a passageway through the eye along the pathway and inserting the shunt into the eye after formation of the passageway.

35. A method as in claim 1, wherein passing the shunt along a pathway from the anterior chamber through the scleral spur of the eye comprises puncturing the scleral spur.

36. A method as in claim 1, wherein the shunt is positioned in the eye approximately 90 degrees from the location of the incision.

37. A method as in claim 1, wherein the shunt is positioned in the eye approximately 90 degrees to approximately 180 degrees from the location of the incision.

38. A method as in claim 1, wherein the shunt includes a marker for placement of the shunt, and further comprising inserting the shunt into the suprachoroidal space until the marker is aligned with a relevant anatomic structure.

39. A method as in claim 38, wherein the anatomic structure is the trabecular meshwork or the scleral spur.

40. A method as in claim 38, wherein the shunt includes an echogenic marker, and further comprising using ultrasound to signal the placement of the echogenic marker within the suprachoroidal space.

41. A method as in claim 1, further comprising using an imaging system while passing the shunt along the pathway to assist in positioning the shunt in the first position.

42. A method as in claim 41, wherein the imaging system comprises at least one of ultrasound, optical coherence tomography, and endoscopic viewing.

43. A method as in claim 1, further comprising mounting the shunt on a delivery device wherein at least a portion of the delivery device transmits energy from the energy source to facilitate entry of the into the suprachoroidal space

44. A method as in claim 43, wherein only a distal tip of the delivery device transmits energy.

45. A method as in claim 43, wherein the energy is RF energy, laser energy, resistive heat energy or ultrasonic energy.

46. A method of implanting an ocular device into the eye, comprising:

forming an incision in the cornea of the eye;

inserting a shunt through the incision into the anterior chamber of the eye wherein at least a portion of the shunt can be opened to permit fluid flow along the shunt;

passing the shunt along a pathway from the anterior chamber through the scleral spur of the eye into the suprachoroidal space; and

positioning the shunt in a first position such that a first portion of the shunt communicates with the anterior chamber and a second portion of the shunt communicates with the suprachoroidal space; and

opening the shunt to permit fluid flow so that the shunt provides a fluid passageway between the suprachoroidal space and the anterior chamber.

47. A method as in claim 46, wherein the shunt is opened by applying at least one of photochemical energy, laser energy, radiofrequency energy, ultrasound, and heat to the shunt.

48. A method as in claim 46, wherein the shunt is opened by uncovering a hole in the shunt.

49. A method as in claim 46, wherein the shunt is opened by inserting a needle through the shunt.

50. A method as in claim 46, wherein the shunt is opened after the shunt is in the first position.

51. A method as in claim 46, further comprising infusing fluid into the eye during delivery of the shunt into the eye.

52. A method as in claim 46, further comprising infusing a dye into the eye to provide visualization of the pathway.

53. A method of implanting an ocular device into the eye, comprising:

forming an incision in the cornea of the eye;

mounting a shunt on a delivery device wherein at least a portion of the shunt or the delivery device has a curvature that matches a curvature of the eye,

inserting the shunt through the incision into the anterior chamber of the eye wherein the shunt includes a fluid passageway;

aiming the shunt relative to the suprachoroidal space such that the curvature of the shunt or the delivery device aligns with the curvature of the eye; and

inserting at least a portion of the shunt into the suprachoroidal space to provide a fluid passageway between the suprachoroidal space and the anterior chamber.

54. A method as in claim 53, further comprising passing the shunt through the scleral spur.

55. A method as in claim 54, wherein passing the shunt through the scleral spur comprises puncturing the scleral spur.

56. A method as in claim 54, wherein passing the shunt through the scleral spur comprises slicing through the scleral spur.

57. A method as in claim 53, wherein the incision is formed in a first location in the eye and wherein the shunt is inserted in the suprachoroidal space 90 degrees away from the first location.

58. A method as in claim 53, further comprising approaching the eye with the delivery device from a lateral side of the eye and inserting the shunt into the suprachoroidal space in a medial side of the eye.

59. A method as in claim 53, wherein the incision is in a first quadrant of the eye and the shunt is inserted into the suprachoroidal space in a different quadrant of the eye.

60. A method of implanting an ocular device into the eye, comprising:

forming an incision in the cornea of the eye;

inserting a shunt through the incision into the anterior chamber of the eye wherein the shunt includes a fluid passageway;

passing the shunt along a pathway from the anterior chamber through the scleral spur of the eye into the suprachoroidal space; and

positioning the shunt in a first position such that a first portion of the fluid passageway communicates with the anterior chamber and a second portion of the fluid passageway communicates with the suprachoroidal space to provide a fluid passageway between the suprachoroidal space and the anterior chamber wherein the shunt is pre-shaped to position the first portion away from the iris.

61. A method as in claim 60, wherein the incision is formed in the limbus of the cornea.

62. A method as in claim 60, wherein the incision is about 1 mm in size.

63. A method as in claim 60, wherein the incision is no greater than about 2.85 mm in size

64. A method as in claim 60, wherein the incision is no greater than about 2.85 mm and is greater than about 1.5 mm in size.

65. A method of implanting an ocular device into the eye, comprising:

forming an incision in the sclera of the eye;

inserting a shunt through the incision into the suprachoroidal space of the eye wherein the shunt includes a fluid passageway;

passing the shunt along a pathway from the suprachoroidal space through the scleral spur of the eye into the anterior chamber; and

positioning the shunt in a first position such that a first portion of the fluid passageway communicates with the anterior chamber and a second portion of the fluid passageway communicates with the suprachoroidal space to provide a fluid passageway between the suprachoroidal space and the anterior chamber.

66. A method as in claim 65, wherein passing the shunt through the scleral spur comprises puncturing the scleral spur.

67. A method as in claim 65, wherein the shunt includes a marker for placement of the shunt, and further comprising inserting the shunt into the suprachoroidal space until the marker is aligned with a relevant anatomic structure.

68. A method as in claim 67, wherein the anatomic structure is the trabecular meshwork or the scleral spur.

69. A method as in claim 65, wherein the shunt includes an echogenic marker, and further comprising using ultrasound to signal the placement of the echogenic marker within the suprachoroidal space.

70. A method as in claim 65, further comprising using an imaging system while passing the shunt along the pathway to assist in positioning the shunt in the first position.

71. A method as in claim 70, wherein the imaging system comprises at least one of ultrasound, optical coherence tomography, and endoscopic viewing.

72. A method as in claim 65, further comprising mounting the shunt on a delivery device wherein at least a portion of the delivery device transmits energy from the energy source to facilitate entry of the into the suprachoroidal space

73. A method as in claim 72, wherein the energy is RF energy, laser energy, resistive heat energy or ultrasonic energy.

74. A glaucoma treatment device, comprising:

an elongate member having a flow pathway, at least one inflow port communicating with the flow pathway, and an outflow port communicating with the flow pathway, wherein the elongate member is adapted to be positioned in the eye such that the inflow port communicates with the anterior chamber, the outflow port communicates with the suprachoroidal space, and at least a portion of the elongate member passes through the scleral spur to provide a fluid pathway between the anterior chamber and the suprachoroidal space when the elongate member is implanted in the eye.

75. A device as in claim 74, wherein the flow pathway is an internal lumen in the elongate member.

76. A device as in claim 75, wherein the elongate member has an inner diameter of about 0.012 inch and an outer diameter of about 0.015 inch.

77. A device as in claim 74, wherein at least a portion of the elongate member has a radius of curvature of at least about 12 mm.

78. A device as in claim 74, wherein the elongate member has a length in the range of about 0.250 inch to about 0.300 inch.

79. A device as in claim 74, further comprising at least one anchor member disposed on the elongate member, the anchor member adapted to anchor into eye tissue.

80. A device as in claim 74, wherein the anchor member comprises at least one of a protrusion, wing, tine, or prong.

81. A device as in claim 74, wherein the anchor member transitions between an retracted state of reduced size and an expanded state of enlarged size.

82. A device as in claim 74, wherein the elongate member is a wick and wherein the flow pathway is a capillary flow pathway.

83. A device as in claim 74, wherein the elongate member is tubular.

84. A device as in claim 74, wherein the elongate member has a tubular portion and a wick portion.

85. A device as in claim 74, further comprising at least one slot in the elongate member.

86. A device as in claim 85, wherein at least one slot is an outflow port or an inflow port.

87. A device as in claim 74, further comprising a sleeve positioned on the elongate member.

88. A device as in claim 87, further comprising at least one slot in the sleeve.

89. A device as in claim 88, wherein the slot extends through the sleeve and through the elongate member.

90. A device as in claim 74, wherein a distal end of the shunt has an atraumatic shape.

91. A device as in claim 74, wherein at least a portion of the shunt is flexible.

92. A device as in claim 74, wherein a distal end of the shunt is sharpened.

93. A device as in claim 74, further comprising a skirt located on the shunt.

94. A device as in claim 93, wherein the skirt has at least one prong adapted to anchor into eye tissue.

95. A device as in claim 93, wherein the flow pathway is on an external surface of the elongate member.

96. A device as in claim 74, wherein the flow pathway is straight.

97. A device as in claim 74, wherein the flow pathway is helical.

98. A device as in claim 74, wherein the elongate member includes a bulbous region.

99. A device as in claim 74, wherein the bulbous region is on a tip of the elongate member.

100. A device as in claim 74 wherein the elongate member includes at least one slice.

101. A device as in claim 100, wherein the slice extends generally along a longitudinal axis of the shunt to define a plurality of longitudinally-extending teeth.

102. A device as in claim 100, wherein the slice is oriented transverse to a longitudinal axis of the shunt.

103. A device as in claim 74, wherein the elongate member include a skirt.

104. A device as in claim 74, wherein the elongate member comprises a stent.

105. A device as in claim 74, wherein the shunt includes a marker for placement of the shunt, the marker being a visual, tomographic, echogenic, or radiopaque marker.

106. A device as in claim 74, wherein the elongate member is coated on an inner or outer surface with at least one material that maintains the patency of a lumen between the suprachoroidal space and the anterior chamber.

107. A device as in claim 74, wherein the elongate member is coated on an inner or outer surface with at least one material that encourages in-growth of tissue to assist with retention of the shunt within the eye.

108. A device as in claim 74, wherein the elongate member is coated on an inner or outer surface with a therapeutic agent.

109. A device as in claim 108, wherein the therapeutic agent is a steroid, an antibiotic, an anti-inflammatory agent, an anticoagulant, an antiglaucomatous, an anti proliferative, or a combination thereof.

110. A device as in claim 74, wherein elongate member is coated with a material that expands outward once the elongate member has been placed in the eye.

111. A device as in claim 74, wherein elongate member is coated with a material that promotes healing of the shunt into surrounding eye tissue.

112. A device as in claim 74, wherein elongate member is coated with a material that facilitates fluid flow.

113. A device as in claim 112, wherein the material is silver.

114. A glaucoma treatment device, comprising:

an elongate member having a flow pathway, at least one inflow port communicating with the flow pathway, and an outflow port communicating with the flow pathway, wherein the elongate member is adapted to be positioned in the eye such that the inflow port communicates with the anterior chamber and the outflow port communicates with the suprachoroidal space, wherein at least a portion of the elongate member includes an enlarged bulbous region adapted to form a space within the suprachoroidal space for accumulation of fluid within the suprachoroidal space.

115. A device as in claim 114, wherein the bulbous region is on a tip of the elongate member.

116. A device as in claim 114, wherein the elongate member has an internal lumen.

117. A device as in claim 115, wherein at least one hole in the bulbous region communicates with the internal lumen.

118. A device as in claim 115, wherein the bulbous region is adapted to transition from a reduced size to an enlarged size.

119. A glaucoma treatment device, comprising:

an elongate member having a flow pathway, at least one inflow port communicating with the flow pathway, and an outflow port communicating with the flow pathway, wherein the elongate member is adapted to be positioned in the eye such that the inflow port communicates with the anterior chamber and the outflow port communicates with the suprachoroidal space, the elongate member having a first region and a second region, wherein the second region is adapted to transition from a first shape to a second shape while the first regions remains unchanged.

120. A device as in claim 119, wherein the second region is a distal region of the elongate member.

121. A device as in claim 119, wherein the second region transitions to a second shape of reduced radial size relative to the first shape.

122. A device as in claim 119, wherein the second region transitions to a second shape having a different radius of curvature relative to a radius of curvature of the first shape.

123. A device as in claim 120, wherein the elongate member is at least partially manufactured of a shape-memory material.

124. A device as in claim 121, wherein at least a portion of the device is manufactured of Nitinol to facilitate the shape change.

125. A device as in claim 121, wherein the second region transitions to a second shape that is tapered relative to the first shape, wherein the tapered shape produces a change in fluid flow characteristics for the elongate body.

126. A glaucoma treatment device, comprising:

a curved member sized to fit within an angle between the cornea and the iris of an eye;

at least two legs extending outwardly from the curved member and shaped to extend into the suprachoroidal space, wherein at least one of the legs provides a fluid flow pathway into the suprachoroidal space.

127. A device as in claim 126, wherein the curved member over a range of up to 180 degrees.

128. A device as in claim 126, wherein the legs have a curvature that conforms to a curvature of the suprachoroidal space.

129. A device as in claim 126, wherein at least one of the leg has an internal lumen that provides a fluid flow passageway between the suprachoroidal space and the anterior chamber of the eye.

130. A glaucoma treatment system, comprising:

an elongate member having a flow pathway, at least one inflow port communicating with the flow pathway, and an outflow port communicating with the flow pathway, wherein the elongate member is adapted to be positioned in the eye such that the inflow port communicates with the anterior chamber and the outflow port communicates with the suprachoroidal space, wherein at least a portion of the elongate member includes an enlarged bulbous region adapted to form a space within the suprachoroidal space for accumulation of fluid within the suprachoroidal space;

a delivery device having an elongate applier that removably attaches to the elongate member, the delivery device including an actuator that removes the elongate member from the applier.

131. A system as in claim 130, wherein the applier has a sharpened distal tip.

132. A system as in claim 130, wherein the applier attaches within an internal lumen of the elongate member.

133. A system as in claim 130, wherein the applier attaches over the elongate member.

134. A system as in claim 130, wherein the applier has a curvature that matches the curvature of the suprachoroidal space.