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

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 inserter to advantageously provide a sterile, easy-to-use package for use by an operator.

1 - 20 . (canceled) 
     
     
         21 . An ocular implant delivery system comprising:
 a generally elongated ergonomic outer housing;   an elongated insertion sleeve partially disposed in the outer housing and having a lumen and a non-linear exposed distal portion extending out of a distal end of the outer housing;   an implant pusher tube partially disposed in and extending outwardly from the distal end of the outer housing, passing through at least a portion of the lumen of the insertion sleeve;   an implant supported within the distal portion of the insertion sleeve and in line with a distal end of the implant pusher tube; and   a trigger mechanically coupled to the outer housing such that actuation of the trigger deploys the implant into an implantation location within an eye.   
     
     
         22 . The delivery system of  claim 21 , wherein the distal portion of the insertion sleeve has a first radius of curvature that provides proper alignment of the implant for suprachoroidal implantation of the implant. 
     
     
         23 . The delivery system of  claim 21 , wherein the distal portion of the insertion sleeve has a radius of curvature that is between 0.4 inches and 2.2 inches. 
     
     
         24 . The delivery system of  claim 21 , wherein the implant is made of a flexible material. 
     
     
         25 . The delivery system of  claim 21 , wherein the implant is curved to have proper curvature and alignment for suprachoroidal implantation. 
     
     
         26 . The delivery system of  claim 21 , wherein the nonlinear exposed distal portion of the insertion sleeve and a nonlinear distal portion of the implant have matching curvatures. 
     
     
         27 . The delivery system of  claim 21 , wherein the implant further comprises a therapeutic agent or drug. 
     
     
         28 . The delivery system of  claim 27 , wherein the therapeutic agent comprises an anti-angiogenesis agent. 
     
     
         29 . The delivery system of  claim 21 , wherein the outer housing further comprises reuse prevention structures designed to limit use of the delivery system to a single use. 
     
     
         30 . The delivery system of  claim 21 , wherein the insertion sleeve further comprises a visual aid for indicating a suitable depth of implant placement during implantation. 
     
     
         31 . The delivery system of  claim 21 , wherein the delivery system is provided in a sterile packaging for single-use operation. 
     
     
         32 . The delivery system of  claim 21 , wherein the implant is prevented from backwards movement by contact between a proximal end of the implant and the distal end of the implant pusher tube. 
     
     
         33 . The delivery system of  claim 21 , further comprising a trigger safety device mechanically engaged with the trigger such that actuation of the trigger cannot occur while the trigger safety device is engaged. 
     
     
         34 . A method of implanting an ocular implant within an eye, the method comprising:
 inserting a distal end of a delivery device loaded with an implant within an insertion sleeve of the delivery device through a pre-formed corneal incision into an anterior chamber of an eye;   advancing a distal end of the delivery device across the anterior chamber to an anterior chamber angle adjacent an implantation site;   advancing the distal end of the delivery device into the implantation site;   actuating a trigger such that the implant reacts against a distal end of an implant pusher tube of the delivery device as the trigger is actuated, thus deploying the implant into the implantation site; and   removing the delivery device from the eye.   
     
     
         35 . The method of  claim 34 , wherein the implantation site is in a suprachoroidal space formed between a choroid and a sclera. 
     
     
         36 . The method of  claim 34 , wherein the implantation site is in a supraciliary space formed between a ciliary body and a choroid. 
     
     
         37 . The method of  claim 34 , wherein the implantation site is in a fibrous attachment zone adjacent a scleral spur. 
     
     
         38 . The method of  claim 34 , further comprising removing a trigger safety device before actuating the trigger. 
     
     
         39 . The method of  claim 34 , further comprising separating iris processes away from a scleral spur with the distal end of the delivery device until the implantation site is formed.