Glaucoma treatment device

• US 8,734,378 B2
• Filed: 09/17/2009
• Issued: 05/27/2014
• 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:
  US12/561,680
• Publication Number:
  US 20100010416A1
• Time in Patent Office: 1,713 Days
• Field of Search: 604/8, 604/9, 606/190, 606/108, 606/166, 606/167, 606/181, 606/172, 606/182, 606/191, 606/192, 606/198, 623/4.1, 623/5.11, 623/6.11, 623/6.64, 623/26, 623/66.1
• US Class Current: 604/8
• 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 for reducing intraocular pressure in an eye, comprising:

(1) introducing through a cornea of an eye into the anterior chamber an ocular implant removably attached to a delivery instrument,

the ocular implant having proximal and distal ends;

the delivery instrument defining a straight longitudinal axis and comprising;

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

(b) an elongated applier operatively coupled to the hand-held component, the elongated applier comprising;

a proximal region aligned along the longitudinal axis of the delivery instrument during introduction of the ocular implant into the anterior chamber;

a distal region curved away from the longitudinal axis during introduction of the ocular implant into the anterior chamber; and

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

(c) a deployment structure having a proximal end coupled to the hand-held component and a distal end positioned around the elongated applier at a location proximal of the ocular implant when the ocular implant is removably attached to the delivery instrument;

(2) bluntly dissecting eye tissue between a portion of a ciliary body and a portion of a sclera from within the anterior chamber using the distal tip of the elongated applier; and

(3) advancing the ocular implant from the anterior chamber toward the supraciliary space through the dissected eye tissue;

(4) using the delivery instrument to position the ocular implant at a target location in the eye while the ocular implant remains in a fixed position relative to the delivery instrument, wherein, when in the target location, the proximal end of the ocular implant is located in the anterior chamber and the distal end of the ocular implant is in communication with the supraciliary space; and

(5) withdrawing the elongated applier in a proximal direction relative to the implant and the deployment structure so as to detach the elongated applier from the implant,

wherein once the implant is detached, aqueous humor is able to flow from the anterior chamber between the proximal and distal ends of the ocular implant toward the supraciliary space, and

wherein the distal region of the elongated applier withdraws into the distal end of the deployment structure and conforms to the straight longitudinal axis of the delivery instrument as the distal region withdraws into the distal end of the deployment structure.

2. The method of claim 1, wherein dissecting eye tissue at a location proximate a scleral spur comprises using the distal end of the ocular implant to dissect eye tissue.

3. The method of claim 1, wherein dissecting eye tissue at a location proximate a scleral spur comprises using a distal end of the delivery instrument to dissect eye tissue.

4. The method of claim 1, wherein dissecting eye tissue comprises bluntly dissecting eye tissue.

5. The method of claim 4, wherein bluntly dissecting eye tissue comprises bluntly dissecting between a portion of a ciliary body and a portion of a sclera.

6. The method of claim 5, wherein bluntly dissecting between a portion of a ciliary body and a portion of a sclera comprises using a distal tip of the delivery instrument to bluntly dissect between the portions, wherein the distal tip of the delivery instrument is sufficiently blunt to avoid penetrating the sclera.

7. The method of claim 1, further comprising delivering fluid into the eye to create a dissection plane hydraulically into a portion of the supraciliary space.

8. The method of claim 7, wherein the fluid is a viscoelastic substance.

9. The method of claim 1, wherein dissecting eye tissue at a location proximate a scleral spur comprises dissecting eye tissue at a location posterior of the scleral spur.

10. The method of claim 1, further comprising advancing the ocular implant from a site of introduction across the anterior chamber to a location proximate the scleral spur of the eye.

11. The method of claim 1, wherein the ocular implant has a distal portion that is rigid in at least an axial direction, and wherein advancing includes moving the distal portion through the dissected eye tissue.

12. The method of claim 1, further comprising regulating flow of aqueous humor through the ocular implant.

13. The method of claim 1, wherein advancing involves locating the distal end of the implant in the supraciliary space.

14. The method of claim 1, wherein advancing involves locating the distal end of the implant in the suprachoroidal space.

15. The method of claim 1, additionally comprising injecting a viscoelastic material through a ciliary muscle attachment of the eye.

16. The method of claim 1, additionally comprising introducing a liquid into the supraciliary space.

17. The method of claim 1, further comprising:

removing a cataract through the incision.

18. The method of claim 17, further comprising implanting a new lens into the eye.

19. The method of claim 1, wherein the ocular implant further comprises a transitional region proximal of the distal end, said transitional region comprising a decreasing radial dimension toward the distal end.

20. The method of claim 19, wherein the ocular implant further comprises one or more outlet ports between the proximal and distal ends.

21. The method of claim 19, wherein the ocular implant further comprises a portion between the proximal and distal ends, said portion having a curvature.

22. The method of claim 1, wherein the ocular implant further comprises one or more outlet ports between the proximal and distal ends.

23. The method of claim 1, wherein the ocular implant further comprises a portion between the proximal and distal ends, said portion having a curvature.

24. The method of claim 1, wherein the delivery instrument is inserted into the anterior chamber through the corneal incision, and further wherein the delivery instrument has a sufficiently small cross-section such that the corneal incision self-seals without suturing upon withdrawal of the delivery instrument from the eye.

25. The method of claim 1, wherein the ocular implant further comprises at least one retention structure for engaging with the dissected eye tissue.

26. The method of claim 1, wherein the at least one retention structure is selected from the group consisting of a protrusion, a wing, a tine, a prong, and a barb.

27. The method of claim 1, wherein the elongated applier is a guidewire.

28. The method of claim 1, wherein the elongated applier is positioned within an internal lumen of the ocular implant.

29. The method of claim 1, the delivery instrument further comprises a deployment structure, and wherein relative movement between the elongated applier and the deployment structure can be used to deploy the ocular implant off of the elongated applier into the eye.

30. The method of claim 1, wherein the ocular implant and the applier are configured such that ocular implant conforms to a shape of the applier when the ocular implant is mounted on the applier.

31. The method of claim 30, wherein the ocular implant transitions to a different shape upon removal of the ocular implant from the applier.

32. The method of claim 31, wherein the ocular implant is configured to prop open a portion of the supraciliary space upon implantation into the eye.

33. The method of claim 31, wherein the ocular implant is configured to prop open a portion of the suprachoroidal space upon implantation into the eye.

34. The method of claim 1, wherein the distal end of the ocular implant resides in and terminates in the supraciliary space when the ocular implant is in the target location.

35. The method of claim 1, wherein the ocular implant remains in a fixed position relative to the entire delivery instrument while the delivery instrument is used to position the ocular implant at the target location in the eye.