Systems and methods for delivering an ocular implant to the suprachoroidal space within an eye

• US 10,188,551 B2
• Filed: 03/13/2017
• Issued: 01/29/2019
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Glaukos Corporation
• Original Assignee: Glaukos Corporation
• Inventors: Rangel-Friedman, Gary, Haffner, David Steven
• Primary Examiner(s): Klein, Benjamin
• Application Number:
  US15/457,824
• Publication Number:
  US 20170312124A1
• Time in Patent Office: 687 Days
• 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 system, comprising:

a generally elongated outer housing;

an elongated insertion needle partially disposed in and extending outwardly from the outer housing, the insertion needle having a lumen;

a pusher tube assembly comprising an implant pusher tube and a pusher tube collar fixedly attached to a proximal portion of the implant pusher tube, a distal portion of the implant pusher tube extending through the lumen of the insertion needle;

a trocar assembly comprising a trocar and a trocar collar fixedly attached to a proximal portion of the trocar, a distal portion of the trocar passing through a lumen of the implant pusher tube;

an implant supported on the distal portion of the trocar, wherein a distal tip of the trocar extends distally beyond a distal-most end of the implant when the implant is supported on the distal portion of the trocar; and

a trocar trigger mechanically coupled to the trocar assembly such that a first actuation of the trocar trigger causes the trocar assembly to move the pusher tube assembly distally relative to the insertion needle to a distal locked position, wherein the implant is exposed from the insertion needle for implantation in a suprachoroidal space of an eye when the pusher tube assembly is at the distal locked position, the trocar trigger being further configured such that a second actuation of the trocar trigger causes the distal tip of the trocar to move proximal to the distal-most end of the implant, thereby releasing the implant from being supported on the distal portion of the trocar.

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

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

4. The delivery system of claim 1, wherein the elongated insertion needle has a non-linear exposed distal portion, wherein the implant pusher tube has a non-linear distal portion, and wherein the trocar has a non-linear distal portion.

6. The delivery system of claim 4, wherein the non-linear exposed distal portion of the insertion needle, the non-linear distal portion of the implant pusher tube, and the non-linear distal portion of the trocar have a substantially matching curvature.

7. The delivery system of claim 6, wherein the implant has a curvature that substantially conforms to the substantially matching curvature of the insertion needle, the implant pusher tube, and the trocar.

5. The delivery system of 4, wherein the non-linear distal portion of the trocar has a predetermined curvature to allow a proper angle of attack to penetrate ocular tissue to provide access for implantation of the implant in the suprachoroidal space.

8. An ocular implant delivery system, comprising:

a generally elongated outer housing;

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

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

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

an implant disposed on the non-linear distal portion of the trocar and being positioned within the non-linear exposed distal portion of the insertion needle, a proximal face of the implant being in contact with a distal face of the implant pusher tube such that the distal face of the implant pusher tube stops the proximal face of the implant from moving proximal of the distal face of the pusher tube; and

a trocar trigger disposed on the outer housing, the trocar trigger being movable between a proximal-most position and a distal-most position, the trocar trigger configured to move the trocar and the implant pusher tube distally relative to the insertion needle when the trocar trigger is moved from the proximal-most position to the distal-most positon, the pusher tube being configured to lock relative to the housing when the trocar trigger reaches the distal-most position, the trocar trigger being further configured to move the trocar distally relative to the implant pusher tube when the trocar trigger moves from the proximal-most position to the distal-most position.

9. The delivery system of claim 8, wherein the implant is configured to drain fluid from an anterior chamber to a suprachoroidal space.

10. The delivery system of claim 8, wherein the insertion needle is configured to create a self-sealing corneal incision having a size of about 1 mm or less.

12. The delivery system of claim 8, wherein the non-linear exposed distal portion of the insertion needle, the non-linear distal portion of the implant pusher tube, and the non-linear distal portion of the trocar have a substantially matching curvature.

13. The delivery system of claim 12, wherein the implant has a curvature that substantially conforms to the substantially matching curvature of the insertion needle, the implant pusher tube, and the trocar.

11. The delivery system of 8, wherein the non-linear distal portion of the trocar has a predetermined curvature to allow a proper angle of attack to penetrate ocular tissue to provide access for implantation of the implant in a suprachoroidal space.

14. An ocular implant delivery system, comprising:

a generally elongated outer housing;

an elongated insertion needle partially disposed in and extending outwardly from the outer housing, the insertion needle having a lumen;

an implant pusher tube fixedly attached to a pusher tube collar, a distal portion of the implant pusher tube extending through the lumen of the insertion needle, the implant pusher tube having a lumen;

a trocar fixedly attached to a trocar collar, a non-linear distal portion of the trocar passing through the lumen of the implant pusher tube, the trocar collar being disposed proximal of the pusher tube collar, the trocar collar being arranged such that moving the trocar collar in a distal direction relative to the outer housing moves the pusher tube collar in the distal direction relative to the outer housing; and

an implant disposed on the non-linear distal portion of the trocar, the implant comprising an implant body and a proximal implant sleeve disposed over the implant body, the implant body comprising distal and proximal stops that hold the sleeve longitudinally in place with respect to the implant body, the proximal stop being sized so that the implant cannot move proximally past the implant pusher tube.

15. The delivery system of claim 14, wherein the elongated insertion needle has a non-linear exposed distal portion and the implant pusher tube has a non-linear distal portion.

16. The delivery system of claim 14, wherein the non-linear distal portion of the trocar has a predetermined curvature to allow a proper angle of attack to penetrate ocular tissue to provide access for implantation of the implant in the suprachoroidal space.

17. The delivery system of claim 15, wherein the non-linear exposed distal portion of the insertion needle, the non-linear distal portion of the implant pusher tube, and the non-linear distal portion of the trocar have a substantially matching curvature.

18. The delivery system of claim 17, wherein the implant has a curvature that substantially conforms to the substantially matching curvature of the insertion needle, the implant pusher tube, and the trocar.

19. The delivery system of claim 14, wherein the implant comprises a therapeutic agent.

20. The delivery system of claim 14, wherein the trocar comprises a distal tip configured to separate an iris process away from a scleral spur.