Ocular implant delivery system and method thereof

• US 7,857,782 B2
• Filed: 02/05/2009
• Issued: 12/28/2010
• Est. Priority Date: 04/07/2001
• Status: Expired due to Term

• Current Assignee: Glaukos Corporation
• Original Assignee: Glaukos Corporation
• Inventors: Tu, Hosheng, Haffner, David, Smedley, Gregory T, Niksch, Barbara A
• Primary Examiner(s): Deak; Leslie R
• Application Number:
  US12/366,585
• Publication Number:
  US 20090138022A1
• Time in Patent Office: 691 Days
• Field of Search: 604/8, 604/9, 604/264, 623/4.1, 623/6.12, 606/108
• US Class Current: 604/8
• 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 27/00 Drainage appliance for wounds or the like , i.e. wound drains, implanted drains negative pressure wound therapy devices A61M1/90; implements for holding wound open A61B17/02 ; middle ear drainage A61F11/202

Abstract

Systems and methods for treating ocular disorders are disclosed. One system has a delivery instrument, with a non-linear axis, configured to be inserted into an anterior chamber of an eye and moved to a location proximate a physiologic outflow pathway of the eye. The delivery instrument carries an implant that has a distal end sized for insertion into tissue such that aqueous humor drains from the anterior chamber to the physiologic outflow pathway. One method involves inserting a non-linear portion of a delivery device into the anterior chamber to position an implant within the eye. Another method involves using a delivery device with a curved distal portion to implant an implant at a location communicating with the physiologic outflow pathway. The delivery can be through a corneal incision and the implant can comprise a drug.

Claims

1. An ocular implant system, comprising:

an ocular implant, the implant comprising an elongated body including a proximal end segment, a distal end segment and an intermediate segment;

the proximal end segment comprising an inlet port arranged on the proximal end segment to communicate with an anterior chamber of an eye;

the intermediate segment extending between the proximal and distal end segments, the intermediate segment having an inner lumen communicating with the inlet port; and

the elongated body including one or more retention features arranged to contact ocular tissue, the elongated body further having one or more outlet ports in communication with the inner lumen and configured to drain aqueous humor to a uveoscleral outflow pathway of the eye; and

a delivery device comprising;

an elongated member carrying the ocular implant and being configured for ab interno insertion of the ocular implant, the elongated member having a distal portion, the distal portion being sufficiently flexible at least when deployed in an eye so as to bend when accessing a target tissue site in an anterior chamber angle within the eye with the elongated member extending through an opening in the cornea or proximate the limbus disposed apart from the target tissue site, the distal portion further being configured to make an opening through ocular tissue at the target tissue site; and

a deployment mechanism acting upon the ocular implant, the deployment mechanism and the elongated member being movable relative to each other so as to deploy the ocular implant from the elongated member and into the ocular tissue through the opening formed by the distal portion of the elongated member.

2. The ocular implant system of claim 1, wherein the proximal segment further comprises a flange configured to abut against ocular tissue when implanted, the flange being sized and shaped to reside in an anterior chamber angle of an eye.

3. The ocular implant system of claim 2, wherein the inlet port is disposed on a proximal side of the flange.

4. The ocular implant system of claim 2, wherein a portion of the intermediate segment which lies next to the flange has a smaller external dimension than an external dimension of the flange.

5. The ocular implant system of claim 1, wherein the delivery device is sufficiently curved so as to extend over a portion of an iris of the eye and into an anterior chamber angle of the eye to access a target tissue site with the elongated member extending through the opening in the cornea or proximate the limbus.

6. The ocular implant system of claim 1, wherein the one or more outlet ports are disposed on the intermediate segment, on the distal end segment, or on both segments.

7. The ocular implant system of claim 1, wherein the one or more retention features are selected from the group consisting of stubs, ribs, pillars, textured surfaces, threads;

flanges, and barbs.

8. The ocular implant system of claim 1, wherein the elongated member of the delivery device comprises a wire.

9. The ocular implant system of claim 1, wherein the ocular implant is formed of polyimide.

10. The ocular implant system of claim 1, wherein the proximal end, intermediate and distal end segments form a generally tubular shape.

11. The ocular implant system of claim 1, wherein the delivery device further comprises a syringe portion configured to make the opening in the cornea or proximate the limbus, the syringe portion having a sufficiently small size such that the opening in the cornea or proximate the limbus is self sealing.

12. The ocular implant system of claim 1, wherein the delivery device further comprises a handpiece connected to the elongated member.

13. The ocular implant system of claim 12, wherein the delivery device further comprises an actuator on the handpiece that is configured to actuate the deployment mechanism.

14. The ocular implant system of claim 1, wherein the distal portion of the elongated member has a deflection range.

15. The ocular implant system of claim 1, wherein at least one retention feature is disposed on the intermediate segment.

16. The ocular implant system of claim 1, wherein the ocular implant is of a sufficient length so that at least a portion of the ocular implant contacts a choroid of the eye when the ocular implant is implanted in the eye.

17. The ocular implant system of claim 16, wherein the portion of the ocular implant that contacts the choroid includes the distal end segment.

18. The ocular implant system of claim 16, wherein at least a portion of the ocular implant contacts ciliary tissue of the eye.

19. A method of treating an ocular condition, the method comprising:

providing an ocular implant comprising an elongated body including a proximal end segment, a distal end segment and an intermediate segment, the proximal end segment comprising an inlet port to communicate with an anterior chamber of the eye, the intermediate segment extending between the proximal and distal end segments, the intermediate segment having an inner lumen communicating with the inlet port, and the elongated body comprising one or more retention features, the elongated body further having one or more outlet ports in communication with the inner lumen and configured to drain aqueous humor to a uveoscleral outflow pathway of the eye; and

forming a first opening to access an anterior chamber of an eye, the first opening being made so as to be self-sealing;

inserting a delivery device carrying the ocular implant through the first opening, wherein the ocular implant is carried by a flexible distal portion of an elongate member of a delivery device;

advancing the ocular implant into the anterior chamber and across an iris to an anterior chamber angle using the delivery device;

forming a second opening in ocular tissue at the anterior chamber angle using the distal portion of the delivery device, wherein the distal portion of the delivery device is sufficiently flexible so as to bend when accessing the ocular tissue at the anterior chamber angle;

implanting the ocular implant into eye tissue in the anterior chamber angle through the second formed opening by moving the elongated member and a deployment mechanism of the delivery device relative to each other so as to advance the ocular implant beyond a distal tip of the elongated member;

contacting ocular tissue with the one or more retention features to inhibit migration of the implant once implanted; and

draining aqueous humor through the ocular implant from the inlet of the ocular implant, which resides in the anterior chamber, through the lumen and out the outlet into a uveoscleral outflow pathway.

20. The method of claim 19 additionally comprising positioning the implant such that a flange on the proximal end segment of the implant resides in the anterior chamber and abuts against eye tissue in the anterior chamber angle to stabilize the implant in the eye.

21. The method of claim 19, wherein advancing the implant into the anterior chamber involves positioning the entire implant in the anterior chamber before inserting the implant into ocular tissue.

22. The method of claim 19, wherein advancing the implant into the anterior chamber involves positioning both the proximal and distal end segments of the implant in the anterior chamber.

23. The method of claim 22, wherein the proximal end of the implant is introduced into the anterior chamber before the distal end segment is inserted into ocular tissue.

24. The method of claim 19, wherein the first opening is made no larger than about 1 mm.

25. The method of claim 19, wherein the implanting the implant comprises positioning at least a portion of the implant so as to be in contact with a choroid of the eye.

26. The method of claim 25, wherein the distal end segment is positioned so as to be in contact with the choroid.

27. The method of claim 25, wherein positioning at least a portion of the implant in contact with the choroid further comprises placing the portion of the implant to contact ciliary tissue of the eye.

28. The method of claim 19, wherein forming the first opening involves using a syringe.