Glaucoma treatment device

• US 8,801,649 B2
• Filed: 10/05/2010
• Issued: 08/12/2014
• 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:
  US12/898,593
• Publication Number:
  US 20110028883A1
• Time in Patent Office: 1,407 Days
• Field of Search: 604/8, 604/9, 604/28, 604/30, 604/264, 604/294, 623/4.1, 606/108, 606/166, 606/167, 606/185
• 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 of implanting an ocular device into an eye, comprising:

inserting a shunt through an incision in a cornea and into an anterior chamber of the eye, the shunt removably attached to a delivery instrument and having a proximal end, a distal end and a fluid passageway extending between the proximal end and the distal end, wherein the shunt has a bend such that the proximal end is oriented along a first axis and the distal end is oriented along a second axis and wherein the first and second axes are non-parallel, the delivery instrument defining a longitudinal axis and comprising;

(a) a hand-held component;

(b) an elongated applier operatively coupled to the hand-held component, the elongated applier comprising a proximal region aligned with the longitudinal axis and a distal region, the distal region being curved away from the longitudinal axis during introduction of the ocular implant into the anterior chamber; and

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

passing the shunt from the anterior chamber past the scleral spur near the ciliary body of the eye towards the supraciliary space; and

positioning the shunt in a first position such that the proximal end of the shunt and a first portion of the fluid passageway is in the anterior chamber, and a second portion of the fluid passageway communicates directly with the supraciliary space to provide a fluid passageway between the supraciliary space and the anterior chamber, and such that the bend is positioned so that the proximal end of the implant orients away from an interior surface of the cornea, wherein positioning the shunt comprises actuating an actuator on the hand-held component of the delivery instrument to move the elongated applier of the delivery instrument in a proximal direction out of the shunt while the shunt remains fixed relative to a portion of the delivery instrument so to release the elongated applier from the shunt, wherein the distal region of the elongated applier withdraws into the deployment structure and conforms to the 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 inserting the shunt through the incision comprises passing the distal end of the shunt through the incision followed by the proximal end of the shunt.

3. The method of claim 1, wherein passing the shunt from the anterior chamber past the scleral spur near the ciliary body of the eye towards the supraciliary space comprises dissecting a portion of the ciliary body away from a portion of scleral tissue.

4. The method of claim 3, wherein the distal end of the shunt has a shape that is sufficiently blunt so as not to penetrate the scleral spur or the portion of scleral tissue.

5. The method of claim 1, wherein passing the shunt from the anterior chamber past the scleral spur near the ciliary body of the eye towards the supraciliary space comprises penetrating the scleral spur.

6. The method of claim 5, wherein the distal end of the shunt has a shape that is sufficiently sharp to penetrate the scleral spur.

7. The method of claim 1, wherein passing the shunt from the anterior chamber past the scleral spur near the ciliary body of the eye towards the supraciliary space comprises creating a puncture in the ciliary body and inserting the shunt through the puncture.

8. The method of claim 7, wherein inserting the shunt through the puncture further comprises passing the shunt through the puncture until a decrease in resistance to passage is sensed.

9. The method of claim 1, wherein positioning the shunt in the first position comprises surrounding the shunt by eye tissue between the anterior chamber and the supraciliary space.

10. The method of claim 1, further comprising mounting the shunt on the elongate applier and inserting the shunt through the incision while the shunt is mounted on the elongate applier.

11. The method of claim 10, wherein a distal tip of the applier has an atraumatic shape.

12. The method of claim 10, further comprising creating a dissection plane between a portion of a choroid and a portion of scleral tissue to expose the suprachoroidal space.

13. The method of claim 12, wherein creating a dissection plane further comprises using a distal end of the shunt to create the dissection plane.

14. The method of claim 12, wherein creating a dissection plane further comprises using a distal tip of the applier to create the dissection plane.

15. The method of claim 10, wherein a distal tip of the applier has a sharpened shape.

16. The method of claim 15, wherein the distal tip of the applier penetrates the scleral spur as the applier approaches the supraciliary space.

17. The method of claim 15, wherein the distal tip of the applier penetrates the ciliary body as the applier approaches the supraciliary space.

18. The method of claim 10, further comprising forming a guide passageway between the anterior chamber and the supraciliary space prior to advancing the applier.

19. The method of claim 18, wherein forming the guide passageway comprises injecting a fluid to hydraulically create a dissection plane into or within the supraciliary space.

20. The method of claim 18, wherein forming the guide passageway comprises injecting a viscoelastic material through the ciliary muscle attachment into the supraciliary space.

21. The method of claim 1, wherein positioning the shunt in a first position comprises positioning a distal end of the shunt between a portion of the ciliary body and a portion of the sclera.

22. The method of claim 1, wherein positioning the shunt in a first position comprises positioning a distal end of the shunt between a portion of the choroid and a portion of the sclera.