Ocular insert apparatus and methods

Abstract

A comfortable insert comprises a retention structure sized for placement under the eyelids and along at least a portion of conjunctival sac of the upper and lower lids of the eye. The retention structure resists deflection when placed in the conjunctival sac of the eye and to guide the insert along the sac when the eye moves. The retention structure can be configured in many ways to provide the resistance to deflection and may comprise a hoop strength so as to urge the retention structure outward and inhibit movement of the retention structure toward the cornea. The insert may move rotationally with deflection along the conjunctival sac, and may comprise a retention structure having a cross sectional dimension sized to fit within folds of the conjunctiva. The insert may comprise a release mechanism and therapeutic agent to release therapeutic amounts of the therapeutic agent for an extended time.

What is claimed is: 
     
         1 . A sustained release ocular drug delivery device for use with a human eye, the device comprising:
 a solid polymeric matrix core containing at least one therapeutic agent, the polymeric matrix core forming an annular segment; and   a polymeric coating completely surrounding the annular segment of the polymeric matrix core, wherein the polymeric coating regulates the release of the at least one therapeutic agent from the polymeric matrix core,   wherein the polymeric matrix core and polymeric coating are non-biodegradable in ocular fluids, and   wherein the device forms a compliant ring-like structure that ranges from an arcuate C-shape having a gap distance extending between ends of the device to a full ring having a 360 degree circumference, and   wherein a cross-sectional diameter of the ring-like structure ranges from 0.1 mm to 3.0 mm.   
     
     
         2 . The device according to  claim 1 , wherein an inner diameter of the ring-like structure is at least 8 mm. 
     
     
         3 . The device according to  claim 2 , wherein the inner diameter has a maximum diameter of about 30 mm. 
     
     
         4 . The device according to  claim 1 , wherein the polymeric matrix core comprises a cross-linkable polymer. 
     
     
         5 . The device according to  claim 1 , wherein the polymeric matrix core comprises a polymer selected from the group consisting of silicones, siloxanes, polyethylenes, acrylates, polyurethanes, polyesters, polypropylenes, polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), polyether ether ketone (PEEK), nylon, polyethylene terephthalate, ultra high molecular weight polyethylene, polycarbonates, and polyurethane. 
     
     
         6 . The device according to  claim 1 , wherein the polymeric coating comprises a thermoplastic polymer. 
     
     
         7 . The device according to  claim 1 , wherein the polymeric coating comprises a polymer selected from the group consisting of silicone, polyethylenes, polypropylenes, poly(methyl methacrylate (PMMA), acrylates, polyurethane, polyester, polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), polyether ether ketone (PEEK), nylon, polyethylene terephthalate, ultra high molecular weight polyethylene, polycarbonates, and polyurethanes. 
     
     
         8 . The device according to  claim 1 , wherein the at least one therapeutic agent is selected from the group consisting of antibiotic agents, antiviral agents, prostaglandin analogues, anti-glaucoma agents, antiallergenic agents, anti-inflammatory agents, anti-angiogenesis agents, immune system modifying agents, anti-cancer agents, antisense agents, antifungal agents, miotics and anticholinesterase agents, parasympathomimetic agents, vasoconstrictive agents, vasodilators, decongestants, cell transport/mobility impending agents, polypeptides and protein agents, steroidal agents, and carbonic anhydrase inhibitor agents. 
     
     
         9 . The device according to  claim 1 , wherein the at least one therapeutic agent is selected from the group consisting of latanoprost, travoprost, bimatoprost, timolol, dorzolamide, triamcinolone, dexamethasone, and cyclosporin. 
     
     
         10 . The device according to  claim 1 , wherein the device is configured to undergo deflection during insertion from an insertion configuration to a deployed configuration. 
     
     
         11 . The device according to  claim 10 , wherein the polymeric coating provides a resistance to deflection to the device so as to maintain placement of the device in the eye. 
     
     
         12 . The device according to  claim 11 , wherein a thickness of the polymeric coating is dimensioned so as to provide the resistance to deflection. 
     
     
         13 . The device according to  claim 10 , wherein the arcuate C-shape has a resistance to inward deflection. 
     
     
         14 . The device according to  claim 13 , wherein the resistance to inward deflection improves retention of the device in an eye. 
     
     
         15 . The device according to  claim 1 , wherein the polymeric coating has a higher durometer than a durometer of the solid polymeric matrix core. 
     
     
         16 . The device according to  claim 1 , wherein the polymeric coating comprises a plurality of holes extending through the polymeric coating to regulate release of the at least one therapeutic agent from the polymeric matrix core. 
     
     
         17 . The device according to  claim 16 , wherein the polymeric matrix core comprises inclusions of the at least one therapeutic agent. 
     
     
         18 . The device according to  claim 17 , wherein the inclusions comprise one or more of solid particles, liquid particles, crystals, or droplets of the at least one therapeutic agent. 
     
     
         19 . The device according to  claim 18 , wherein a release rate of the at least one therapeutic agent from the device is substantially zero order when the inclusions remain in the polymeric matrix core and transitions to substantially first order when the inclusions are substantially dissolved. 
     
     
         20 . The device according to  claim 1 , wherein the ring-like structure has a convex cross-sectional shape that is circular or spherical.