SYSTEMS AND METHODS FOR DELIVERING AN OCULAR IMPLANT TO THE SUPRACHOROIDAL SPACE WITHIN AN EYE

• US 20150065940A1
• Filed: 03/11/2014
• Published: 03/05/2015
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Glaukos Corporation
• Original Assignee: Glaukos Corporation
• Inventors: Haffner, David S., Rangel-Friedman, Gary
• Granted Patent: US 9,592,151 B2
• Time in Patent Office: Days
• US Class Current: 604/8
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61F 9/00781 Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment drainage implants in general A61M27/002

Abstract

Delivery devices, systems and methods are provided for inserting an implant into an eye. The delivery or inserter devices or systems can be used to dispose or implant an ocular stent or implant, such as a shunt, in communication with the suprachoroidal space, uveal scleral outflow pathway, uveoscleral outflow path or supraciliary space of the eye. The implant can drain fluid from an anterior chamber of the eye to a physiologic outflow path of the eye, such as, the suprachoroidal space, uveal scleral outflow pathway, uveoscleral outflow path or supraciliary space. Alternatively, or in addition, the implant can elute a drug or therapeutic agent. The delivery or inserter devices or systems can be used in conjunction with other ocular surgery, for example, but not limited to, cataract surgery through a preformed corneal incision, or independently with the inserter configured to make a corneal incision. The implant can be preloaded with or within the inserter to advantageously provide a sterile package for use by the surgeon, doctor or operator.

Claims

1. An ocular implant delivery device, comprising:

a generally elongated outer housing and handpiece that is ergonomically contoured;

an elongated insertion sleeve partially disposed in the outer housing and having a non-linear exposed distal portion;

a trocar passing through a lumen of the insertion sleeve and having a non-linear distal portion extending beyond the non-linear portion of the insertion sleeve;

an implant disposed on the non-linear portion of the trocar and being positioned distally of the non-linear portion of the insertion sleeve; and

a trigger operatively coupled to the trocar such that actuation of the trigger retracts the trocar and causes the implant to be located in a suprachoroidal space of an eye.

2. The delivery device of claim 1, wherein the insertion sleeve is configured to extend through a corneal incision and into an anterior chamber of the eye.

3. The delivery device of claim 1 wherein the trocar is configured to have a predetermined flexibility.

4. The delivery device of claim 1, wherein the non-linear portion of the trocar has a predetermined curvature.

5. The delivery device of claim 4, wherein the implant has a predetermined curvature which substantially matches the curvature of the non-linear portion of the trocar.

6. The delivery device of claim 1, wherein the trigger is manually controlled and held in a forward position, and retracted after the implantation of the implant.

7. The delivery device of claim 1, wherein the device is used in conjunction with a cataract surgery procedure.

8. The delivery device of claim 1, wherein the implant is configured to drain fluid from the anterior chamber to the suprachoroidal space.

9. A method of implanting a suprachoroidal implant, comprising:

inserting an insertion sleeve of an implant delivery device into an anterior chamber of an eye through a corneal incision;

advancing an implant disposed on a distal portion of the device across the anterior chamber;

positioning a distal tip of a trocar proximate a suprachoroidal space of the eye, wherein the trocar extends through a lumen of the implant, and wherein the distal tip extends beyond the distal end of the implant;

penetrating ocular tissue with the distal tip of the trocar and positioning the implant in the suprachoroidal space; and

actuating a trigger of the device to retract the trocar from the suprachoroidal space while leaving the implant implanted in the suprachoroidal space.

10. The method of claim 9, wherein the corneal incision is a preformed incision.

11. The method of claim 9 wherein the method is performed in combination with another ocular surgery.

12. The method of claim 11, wherein the other ocular surgery comprises a cataract surgery.

13. The method of claim 9, wherein the method further comprises at least one of draining fluid from the anterior chamber and eluting a therapeutic agent using the implant.

14. The method of claim 9, wherein the implant has a predetermined curvature which substantially conforms to the curvature of a distal portion of the trocar.

15. The method of claim 9, wherein a distal portion of the insertion sleeve proximal to the implant has a non-linear configuration.

16. An ocular implant delivery device, comprising:

a generally elongated outer housing and handpiece that is ergonomically contoured;

an elongated insertion needle partially disposed in the outer housing and having a non-linear exposed distal portion;

an implant pusher tube extending through a lumen of the insertion needle and having a non-linear distal portion;

a trocar passing through a lumen of the pusher tube and having a non-linear distal portion;

an implant disposed on the non-linear portion of the trocar and being positioned within the non-linear portion of the insertion needle; and

a pusher tube trigger operatively coupled to the pusher tube such that actuation of the pusher tube trigger causes the implant to be exposed for implantation in a suprachoroidal space of an eye.

17. The delivery device of claim 16, wherein the insertion needle is configured to create a self-sealing corneal incision having a size of about 1 mm or less.

18. The delivery device of claim 16 wherein the non-linear portions of the insertion needle, pusher tube and trocar have a substantially matching curvature.

19. The delivery device of claim 18, wherein the implant has a curvature that substantially conforms to the curvatures of the insertion needle, pusher tube and trocar.

20. The delivery device of claim 16, wherein the pusher tube trigger is operatively coupled to a trocar trigger.

21. The delivery device of claim 20, wherein the trocar is advancable and retractable by actuation of the trocar trigger.

22. The delivery device of claim 16, wherein, when fully advanced, the pusher tube is locked to prevent further motion.

23. The delivery device of claim 16, wherein the delivery device is configured for single-use operation.

24. A method of implanting a suprachoroidal implant, comprising:

forming a self-sealing corneal incision using an insertion needle of an implant delivery device;

actuating a trigger assembly to advance an implant and a trocar into an anterior chamber of an eye, wherein the implant is located on a distal portion of the trocar, and wherein the implant and the distal portion of the trocar have substantially the same curvature;

positioning a distal tip of the trocar adjacent a suprachoroidal space of the eye;

penetrating ocular tissue using the distal tip of the trocar and locating the implant in the suprachoroidal space; and

retracting the trocar from within the implant by actuating a trocar trigger.

25. The method of claim 24, wherein a pusher tube is used to move the implant from within the insertion needle and expose it for implantation.

26. The method of claim 24 wherein the trigger assembly comprises a pusher tube trigger and the trocar trigger which are operatively coupled.

27. The method of claim 24, wherein the method further comprises at least one of draining fluid from the anterior chamber and eluting a therapeutic agent using the implant.

28. The method of claim 24, wherein the distal portion of the trocar, the implant and a distal portion of the insertion needle all have substantially matching curvatures.

29. The method of claim 28, wherein a distal portion of an implant pusher tube has substantially the same curvature as the distal portions of the trocar and the insertion needle and as the implant.

30. The method of claim 24, wherein the insertion needle comprises a 25±

5 gauge needle.