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

• US 20160038338A1
• Filed: 03/12/2014
• Published: 02/11/2016
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Glaukos Corporation
• Original Assignee: Glaukos Corporation
• Inventors: Rangel-Friedman, Gary, Haffner, David S.
• Granted Patent: US 10,285,853 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 a suprachoroidal 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 or other portion of the uveoscleral outflow path. 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 in serter to advantageously provide a sterile, easy-to-use package for use by an operator.

Claims

1. An ocular implant deliver)/system comprising:

a deliver)/device comprising;

a generally elongated outer housing that is ergonomically contoured;

an elongated insertion sleeve partially disposed in the outer housing and having a non-linear exposed distal portion extending out of a distal end of the housing,

wherein the non-linear exposed distal portion has a curvature adapted to conform to an anatomical curvature of the eye;

an obturator passing through a lumen of the insertion sleeve and having a non-linear distal portion extending beyond the non-linear distal portion of the insertion sleeve,

wherein, in use, the non-linear distal portion of the obturator is adapted to provide access to a suprachoroidal space through a ciliary muscle attachment,

wherein the non-linear distal portion of the obturator is flexible and has a curvature adapted to maintain pressure against the sclera during insertion into the suprachoroidal space; and

a trigger operatively coupled to the obturator such that inovement of the trigger towards a proximal end of the housing retracts the obturator within the insertion sleeve; and

an implant. adapted to be disposed on the non-linear portion of the obturator and positioned distally of the non-linear distal portion of the insertion sleeve prior to insertion of the delivery device into an eye,

wherein, in use, a distal end of the insertion sleeve is adapted to react against a proximal end of the implant as the obturator is being retracted to deliver the implant.

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

3. The system of claim 1, wherein the implant has a curvature which substantially matches the curvature of the non-linear portion of the obturator.

4. The system of claim 3, wherein a curvature of the non-linear distal portion of the obturator and a curvature of the implant are larger than a diameter of the eye.

5. The system of any preceding claim, wherein, in use, the trigger is manually controlled and held in a forward position, and retracted in a backward motion to cause delivery of the implant once a distal end of the implant has been advanced to a desired location within the suprachoroidal space, wherein the backward motion of the obturator is adapted to prevent against over-insertion of the implant within the suprachoroidal space.

6. The system of any preceding claim, wherein a distal tip of the obturator is rounded so as not to cause scraping of the sclera while still being adapted to provide access to the suprachoroidal space through the ciliary muscle attachment.

7. The system of any preceding claim, wherein the implant is an elongate tube, and wherein an outer diameter of the implant is between 300 and 400 microns.

8. The system of any preceding claim, wherein a distal portion of the implant includes a plurality of circumferential retention members.

9. The system of any preceding claim, wherein a distal tip of the implant is tapered and wherein a proximal end of the implant includes a flange.

10. The system of any preceding claim, wherein the delivery device further comprises reuse prevention structures adapted to prevent reuse of the delivery device.

11. The system of claim 10, wherein the reuse prevention structures comprise a pair of glue blocks mounted on each side of a trigger of the obturator adapted to melt upon sterilization to lock the trigger against further use.

12. The system of any preceding claim, wherein the implant is provided in a kit with the implant preloaded on the obturator.

13. An ocular implant delivery system comprising:

a generally elongated outer housing 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 elongated insertion needle and having a non-linear distal portion;

an obturator passing through a lumen of the pusher tube and having anon-distal portion;

wherein, in use, the non-linear distal portion of the obturator is adapted to provide access to a suprachoroidal space through a ciliary muscle attachment,

wherein the non-linear distal portion of the obturator is flexible and has a curvature adapted to maintain pressure against the sclera during insertion into the suprachoroidal space; and

a pusher tube trigger operatively coupled to the pusher tube such that movement of the pusher tube trigger towards a proximal end of the housing retracts the obturator toward the housing,

wherein, in use, a distal end of the pusher tube is adapted to react against a proximal end of an implant loaded on to the obturator as the obturator is being retracted within the housing to deliver the implant.

14. The system of claim 13, wherein the insertion needle is a corneal penetration needle adapted to create a self-sealing corneal incision.

15. The system of claim 13 or 14, wherein the non-linear portions of the insertion needle, pusher tube and obturator have a substantially matching curvature.

16. The system of claim 15, further comprising the implant, and wherein the implant has a curvature that substantially conforms to the curvatures of the insertion needle, pusher tube and obturator.

17. The system of any of claims 13-16, wherein the pusher tube trigger is operatively coupled to a trigger of the obturator.

18. The system of claim 17, wherein the obturator is advanceable and retractable by actuation of the trigger of the obturator.

19. The system of any of claims 13-18, wherein, when fully advanced, the pusher tube is locked to prevent further motion.

20. The system of any of claims 13-19, further comprising reuse prevention structures configured to limit use to a single use.

21. The system of claim 20, wherein the reuse prevention structures comprise a pair of glue blocks mounted on each side of the pusher tube trigger adapted to melt upon sterilization to lock the pusher tube trigger against further use.

22. The system of any of claims 13-21, wherein the insertion needle comprises a 25±

5 gauge needle.

23. The system of claim 16, wherein the implant is provided in a kit with the implant preloaded on the obturator.

24. An ocular implant delivery device, comprising:

a generally elongated outer housing that is ergonomically contoured;

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

a tubular support member surrounding a portion of the elongated insertion sleeve, the tubular support member having a proximal end within the outer housing and a distal end extending outside of the outer housing, wherein the tubular support member is configured to facilitate coupling of the elongated insertion sleeve to the outer housing, and wherein the tubular support member surrounds a portion of the elongated insertion sleeve;

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

a trigger operatively coupled to the obturator such that actuation of the trigger retracts the obturator into the insertion sleeve, thereby causing a proximal end of an implant disposed on the non-linear portion of the obturator to react against a distal end of the insertion sleeve so as to facilitate deployment of the implant from the obturator,

wherein the non-linear distal portion of the obturator carrying the implant is configured to be advanced into a suprachoroidal space of an eye,

wherein the non-linear distal portion of the obturator has a curvature configured to be larger than a diameter of the eye.