SYSTEM FOR SHAPING AND IMPLANTING BIOLOGIC INTRAOCULAR STENT FOR INCREASED AQUEOUS OUTFLOW AND LOWERING OF INTRAOCULAR PRESSURE
Systems and methods for preparation of an implant and ab interno insertion of the implant into an eye of a patient including a tissue cartridge configured to receive and hold a patch of a material; a cutting device; and a delivery device. Related devices, systems, and methods are provided.
1 . A system for treatment of a condition of an eye, the system comprising:
a nose cone assembly having a distal end region coupled to a shaft and a proximal end region comprising an attachment mechanism, wherein the shaft comprises an internal lumen and a distal opening from the internal lumen, wherein at least a distal end region of the shaft is sized and shaped for ab interno insertion into an anterior chamber of the eye and for positioning at least in part within Schlemm's Canal through a trabecular meshwork; and
an implant formed from minimally-modified tissue, the implant having an elongate shape and no lumen, wherein the implant is positioned within the internal lumen near the distal end region of the shaft and is deployable from the internal lumen into Schlemm's Canal to structurally reinforce Schlemm's Canal and provide fluid communication between the anterior chamber and Schlemm's Canal.
2 . The system of claim 1 , wherein at least a proximal portion of the shaft extends along a longitudinal axis and the distal end region of the shaft is angled or curved away from the longitudinal axis.
3 . The system of claim 1 , wherein the implant has a first size when positioned within the internal lumen of the shaft and wherein the implant has a second size after deployment from the internal lumen, the second size being larger than the first size.
4 . The system of claim 3 , wherein the second size is configured to structurally reinforce Schlemm's Canal.
5 . The system of claim 4 , wherein the implant creates a gap that allows aqueous to flow longitudinally along sides of the implant within Schlemm's Canal.
6 . The system of claim 5 , wherein the tissue is permeable for further aqueous outflow.
7 . The system of claim 1 , wherein the implant has a length that is 1-10 mm.
8 . The system of claim 1 , wherein the implant has a width that is 0.1-1.5 mm.
9 . The system of claim 1 , wherein the implant has a thickness that is 0.1-0.8 mm.
10 . The system of claim 1 , wherein the implant further comprises one or more therapeutic agents deliverable from the tissue.
11 . The system of claim 1 , wherein the distal end region of the shaft is sized and shaped for ab interno insertion into the anterior chamber through an incision in a cornea of the eye.
12 . The system of claim 11 , wherein the incision is self-sealing.
13 . The system of claim 11 , wherein the incision is less than about 3.5 mm.
14 . The system of claim 1 , wherein an inner diameter of the shaft is about 600 microns to about 800 microns.
15 . The system of claim 1 , wherein the distal end region of the shaft is flexible.
16 . The system of claim 1 , further comprising a proximal handle comprising a distal attachment mechanism, wherein the attachment mechanism of the nose cone assembly is reversibly attachable to the distal attachment mechanism of the proximal handle.
17 . The system of claim 16 , wherein the proximal handle comprises an actuator configured to perform at least a first actuation of the actuator to deploy the implant positioned within the distal end region of the shaft.
18 . The system of claim 17 , wherein the at least a first actuation of the actuator retracts the nose cone assembly proximally relative to an elongate rod configured to remain fixed relative to the nose cone assembly thereby releasing the implant from the internal lumen.
19 . The system of claim 18 , wherein the proximal handle further comprises a reset mechanism to perform at least a second actuation of the actuator.
20 . The system of claim 1 , wherein the tissue is scleral tissue or corneal tissue.