Systems and methods for delivering an ocular implant to the suprachoroidal space within an eye
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 inserter to advantageously provide a sterile, easy-to-use package for use by an operator.
1. An ocular implant delivery system comprising:
a delivery device comprising:
a generally elongated outer housing that is 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 first radius of curvature;
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 the non-linear distal portion of the obturator has a second radius of curvature that is larger than the first radius of curvature,
wherein, in use, the non-linear distal portion of the obturator is adapted to provide access to a suprachoroidal space of an eye through a ciliary muscle attachment,
wherein the non-linear distal portion of the obturator is flexible; and
a trigger mechanically coupled to the obturator such that movement 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 the 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 release 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 radius of curvature which substantially matches the second radius of curvature of the non-linear distal portion of the obturator.
4. The system of claim 3 , wherein the second radius of curvature of the non-linear distal portion of the obturator and the radius of curvature of the implant are larger than a curvature of the eye.
5. The system of claim 1 , wherein, in use, the trigger is manually controlled and held in a forward position, and retracted in a backward motion to cause release 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 claim 1 , 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 claim 1 , 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 claim 1 , wherein a distal portion of the implant includes a plurality of circumferential retention members.
9. The system of claim 1 , wherein a distal tip of the implant is tapered and wherein a proximal end of the implant includes a flange.
10. The system of claim 1 , 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 the trigger and adapted to melt upon sterilization to lock the trigger against further use.
12. The system of claim 1 , wherein the implant is provided in a kit with the implant preloaded on the obturator.
13. The system of claim 1 , wherein in use, the trigger is manually controlled and held in a forward position during implantation, and then retracted in a backward motion to cause release of the implant once the implant has been advanced to a desired location within the suprachoroidal space.
14. The system of claim 1 , wherein a body of the implant includes a plurality of circumferential retention members.
15. The system of claim 1 , wherein a distal tip of the implant is rounded or beveled and wherein a proximal end of the implant includes a flange.
16. The system of claim 1 , wherein the first radius of curvature of the elongated insertion sleeve is configured to provide proper alignment of the obturator for suprachoroidal implantation of the implant.
17. The system of claim 1 , wherein the second radius of curvature of the non-linear distal portion of the obturator is sized to maintain pressure against a sclera of the eye during insertion into the suprachoroidal space.
18. An ocular implant delivery device, comprising:
a generally elongated outer housing that is contoured;
an elongated insertion sleeve partially disposed in the outer housing and having a non-linear exposed distal portion that has a first radius of curvature;
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;
an 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, wherein the non-linear distal portion of the obturator has a second radius of curvature that is larger than the first radius of curvature; and
a trigger mechanically 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.
19. The system of claim 18 , wherein the implant is an elongate tube, and wherein an outer diameter of the implant is between 300 and 400 microns.
20. The system of claim 18 , wherein a distal portion of the implant includes a plurality of circumferential retention members.
21. The system of claim 18 , wherein a distal tip of the implant is tapered and wherein a proximal end of the implant includes a flange.
22. The system of claim 18 , wherein a distal tip of the implant is rounded or beveled and wherein a proximal end of the implant includes a flange.
23. The system of claim 18 , wherein the implant is provided in a kit with the implant preloaded on the obturator.
24. The system of claim 18 , wherein in use, the trigger is manually controlled and held in a forward position during implantation, and then retracted in a backward motion to cause release of the implant once the implant has been advanced to a desired location within the suprachoroidal space.
25. The system of claim 18 , wherein the curvature of the non-linear distal portion of the obturator is configured to be larger than a curvature of the eye.