Glaucoma treatment device

• US 8,721,656 B2
• Filed: 12/22/2006
• Issued: 05/13/2014
• Est. Priority Date: 01/17/2006
• Status: Active Grant

• Current Assignee: Alcon Incorporated
• Original Assignee: Transcend Medical Incorporated (Alcon Incorporated)
• Inventors: De Juan, Eugene Jr., Boyd, Stephen, Deem, Mark E., Gifford, Hanson S. III, Rosenman, Dan
• Primary Examiner(s): MARCETICH, ADAM M
• Application Number:
  US11/615,810
• Publication Number:
  US 20070191863A1
• Time in Patent Office: 2,699 Days
• Field of Search: 604/8, 604/93.01, 604/289, 604/540, 604/327, 623/4.1, 606/108
• 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. An ocular implant system, comprising:

(a) an ocular implant, comprising;

a tube having a proximal region, a distal region, and an internal lumen formed by an annular wall,

wherein the tube has at least one ingress to the internal lumen that communicates with the anterior chamber of the eye when the tube is positioned in the eye in a deployed location and at least one egress from the internal lumen that fluidly communicates with the suprachoroidal space when the tube is positioned in the eye in the deployed location, wherein the at least one egress includes at least one opening in the distal region of the tube; and

(b) a delivery instrument defining a longitudinal axis and comprising;

(i) a hand-held component operatively coupled to an elongated member, the handheld component coupled to an actuator that can be actuated to move the elongated member in a proximal direction relative to the ocular implant,

(ii) the elongated member having a diameter and cross-sectional shape configured to be inserted through the internal lumen of the ocular implant such that the ocular implant is removably coupled to the elongated member, the elongated member comprising;

a proximal region aligned along the longitudinal axis of the delivery instrument;

a distal region curved away from the longitudinal axis; and

a distal tip that forms the distal-most portion of the delivery instrument when the ocular implant is removably coupled to the elongated member during delivery through an anterior chamber, wherein the distal tip is configured to bluntly dissect eye tissue; and

(iii) a deployment structure aligned along the longitudinal axis of the delivery instrument between a proximal end and a distal end of the deployment structure, wherein the proximal end is coupled to the hand-held component and the distal end is positioned around the elongated member at a location proximal of the ocular implant when the distal region of the elongated member is inserted through the ocular implant,

wherein the delivery instrument is configured to;

introduce the ocular implant through the cornea of the eye while the delivery instrument and the ocular implant remain fixed relative to one another,

advance the ocular implant through the anterior chamber while the entire delivery instrument and the ocular implant remain fixed relative to one another,

dissect at least a portion of the ciliary body from the sclera at a location proximate a sclera spur using the distal tip of the elongated member to form a dissected tissue plane between the ciliary body and the sclera while the delivery instrument and the ocular implant remain fixed relative to one another,

advance the ocular implant toward the suprachoroidal space through the dissected tissue plane while the entire delivery instrument and the ocular implant remain fixed relative to one another, and

withdraw the elongated member into the distal end of the deployment structure so as to uncouple the ocular implant from the elongated member and into the deployed location as a result of actuation of the actuator causing the elongated member to move in a proximal direction while the ocular implant remains substantially fixed in place relative to eye tissue,

wherein the distal region of the elongated member is flexible relative to the deployment structure such that the distal region conforms to the longitudinal axis of the delivery instrument when withdrawn into the deployment structure.

2. An implant as in claim 1, wherein the at least one opening in the distal region of the tube comprises an opening located at a distal-most end of the tube.

3. An implant as in claim 2, wherein the at least one opening in the distal region of the tube comprises a plurality of side openings interspersed along a side of the tube.

4. An implant as in claim 3, wherein the tube includes a series of annular grooves, wherein all of the side openings are located distal of the series of annular grooves on the tube.

5. An implant as in claim 4 wherein the at least one opening in the distal region of the tube comprises a plurality of side openings interspersed along a side of the tube, wherein all of the side openings are located distal of the series of annular grooves on the tube.

6. An implant as in claim 1, wherein the at least one opening in the distal region of the tube comprises a plurality of side openings interspersed along a side of the tube.

7. An implant as in claim 1, wherein the at least one opening in the distal region of the tube comprises an opening located at a distal-most end of the tube, and wherein the tube includes a series of annular grooves that form alternating raised and lowered surfaces along at least a portion of the length of the tube.

8. An implant as in claim 1, wherein the at least one ingress comprises an opening in the proximal-most end of the tube at least partially surrounded by an annular flange formed by the first region of increased wall thickness, and the at least one opening in the distal region of the tube comprises an opening on a distal-most end of the tube.

9. An implant as in claim 8, wherein the at least one opening in the distal region of the tube further comprises a plurality of side openings interspersed along a side of the tube.

10. An implant as in claim 1, wherein the tube has a circular cross-sectional shape.

11. An implant as in claim 1, wherein the tube has an oval cross-sectional shape.

12. An implant as in claim 1, wherein the at least one opening in the distal region of the tube is positioned in the supraciliary space when the implant is positioned in the eye.

13. An implant as in claim 12, wherein the first region of increased wall thickness comprises an annular flange that is located in the anterior chamber when the implant is positioned in the eye.

14. An implant as in claim 13, wherein 1 mm to 2 mm of a proximal length of the tube is located in the anterior chamber when the implant is positioned in the eye.

15. An implant system as in claim 1, wherein the elongated member is configured to be inserted through the internal lumen of the ocular implant such that a distal end of the elongate member extends beyond a distal end of the ocular implant.

16. An implant system of claim 15, wherein the ocular implant comprises a second shape that is different from a first shape of the elongated member, wherein at least one of the first shape and the second shape changes when the elongated member is inserted through the internal lumen of the ocular implant.

17. An implant system of claim 1, wherein the delivery instrument is configured to position the ocular implant at the deployed location without a sheath surrounding at least a portion of the tube.

18. An implant system of claim 1, wherein only the elongated member retracts to uncouple the ocular implant from the delivery instrument.

19. An implant system of claim 1, wherein the self-sealing corneal incision comprises an opening in the cornea that is no greater than 2.85 mm in size.

20. An implant system of claim 1, wherein the longitudinal axis is straight.

21. An ocular implant system, comprising:

(a) an ocular implant, comprising;

a tube having a proximal region, a distal region, and an internal lumen,

wherein the tube has at least one entrance to the internal lumen that communicates with the anterior chamber of an eye when the tube is positioned in the eye in a deployed location and at least one exit from the internal lumen that fluidly communicates with the suprachoroidal space when the tube is positioned in the eye in the deployed location to permit aqueous to flow through the lumen from the anterior chamber toward the suprachoroidal space;

a flange extending at least partially around a proximal end of the tube, wherein the flange at least partially surrounds the at least one entrance to the internal lumen; and

(b) a delivery instrument defining a longitudinal axis and comprising;

(i) a hand-held component having an actuator;

(ii) an elongated member operatively coupled to the handheld component, the elongated member comprising;

(1) a proximal region aligned along the longitudinal axis of the delivery instrument;

(2) a distal region shaped to curve away from the longitudinal axis; and

(3) a distal tip that forms the distal-most portion of the delivery instrument during introduction of the ocular implant into the anterior chamber, the distal tip configured to bluntly dissect eye tissue; and

(iii) a deployment structure having a proximal end coupled to the hand-held component and a distal end aligned along the longitudinal axis and positioned around the elongated member at a location proximal of the ocular implant when the ocular implant is removably attached to the delivery instrument,

wherein the distal region of the elongated member is flexible relative to the deployment structure and is configured to withdraw in a proximal direction relative to the ocular implant into the distal end of the deployment structure and conform to the longitudinal axis of the delivery instrument to uncouple the ocular implant from the elongated member at the deployed location as a result of actuation of the actuator causing the elongated member to move in a proximal direction while the ocular implant remains substantially fixed in place relative to eye tissue.

22. An implant system as in claim 21, wherein the at least one exit comprises an opening at a distal end of the tube.

23. An implant system as in claim 22, wherein the at least one exit further comprises a plurality of side openings interspersed along the distal region of the tube.

24. An implant system as in claim 21, wherein the at least one exit comprises a plurality of side openings interspersed along the distal region of the tube.

25. An implant system as in claim 21, wherein the annular flange is located in the anterior chamber when the implant is positioned in the eye.

26. An implant system as in claim 25, wherein 1 mm to 2 mm of a proximal length of the tube is located in the anterior chamber when the implant is positioned in the eye.

27. An implant system as in claim 21, wherein the at least one exit from the internal lumen is positioned in the suprachoroidal space when the tube is positioned in the eye.

28. An implant system of claim 21, wherein at least a portion of the elongated member comprises a first shape that is curved.

29. An implant system of claim 28, wherein the first shape matches a curvature of the eye or a curved contour of the dissection tissue plane.

30. An implant system of claim 29, wherein the ocular implant comprises a second shape that is different from the first shape of the elongated member, wherein at least one of the first shape and the second shape changes when the elongated member is inserted through the internal lumen of the ocular implant.

31. An implant system of claim 21, wherein the delivery instrument is configured to position the ocular implant at the deployed location without a sheath surrounding at least a portion of the tube.

32. An implant system of claim 21, wherein the self-sealing corneal incision comprises an opening in the cornea that is no greater than 2.85 mm in size.

33. An implant system of claim 21, wherein the longitudinal axis is straight.