Drug Delivery Methods, Structures, and Compositions for Nasolacrimal Systems

Abstract

An implant for insertion into a punctum of a patient comprises a body. The body has a distal end, a proximal end, and an axis therebetween. The distal end of the body is insertable distally through the punctum into the canalicular lumen. The body comprises a therapeutic agent included within an agent matrix drug core. Exposure of the agent matrix to the tear fluid effects an effective therapeutic agent release into the tear fluid over a sustained period. The body has a sheath disposed over the agent matrix to inhibit release of the agent away from the proximal end. The body also has an outer surface configured to engage luminal wall tissues so as to inhibit expulsion when disposed therein. In specific embodiments, the agent matrix comprises a non-bioabsorbable polymer, for example silicone in a non-homogenous mixture with the agent.

1 - 53 . (canceled) 
     
     
         54 . An ocular implant for delivering at least one therapeutics agent to an eye for an extended period of time, comprising:
 a body comprising a support structure;   a therapeutic matrix comprising a therapeutic agent and a polymer, wherein at least a portion of the therapeutic matrix is exposed to tear fluid; and   wherein the body is adapted to release the therapeutic agent at therapeutic levels to the eye for at least one month.   
     
     
         55 . The implant of  claim 54 , wherein the polymer comprises silicone. 
     
     
         56 . The implant of  claim 54 , wherein the therapeutic agent is a prostaglandin analog. 
     
     
         57 . The implant of  claim 54 , wherein the therapeutic agent is latanoprost, bimatoprost, travoprost or Timolol. 
     
     
         58 . The implant of  claim 54 , wherein the body comprises a shape memory polymer. 
     
     
         59 . The implant of  claim 54 , wherein the body comprises acrylates, polyethylenes, polyurethane, polyurethane, hydrogel, polyester, polypropylene, polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), polyether ether ketone (PEEK), nylon, extruded collagen, polymer foam, silicone rubber, polyethylene terephthalate, ultra high molecular weight polyethylene, polycarbonate urethane, polyurethane, polyimides, stainless steel, nickel-titanium alloy, titanium, stainless steel, or cobalt-chrome alloy. 
     
     
         60 . The implant of  claim 57 , wherein an amount of bimatoprost loaded in the implant is approximately 5 to 40 ug. 
     
     
         61 . The implant of  claim 57 , wherein the bimatoprost is formulated for extended release of 3 to 6 months. 
     
     
         62 . The implant of  claim 57 , wherein the bimatoprost is formulated for extended release of 6 to 12 months. 
     
     
         63 . The implant of  claim 54 , wherein the therapeutic matrix further comprises an additive to increase solubility of the therapeutic agent in the matrix. 
     
     
         64 . The implant of  claim 54 , wherein the therapeutic matrix is adapted in response to surfactants in the tear fluid to provide sustained delivery of the therapeutic agent into the tear fluid at therapeutic levels. 
     
     
         65 . A composition comprising a polymer matrix and a prostaglandin analog, wherein the prostaglandin analog is dispersed in the matrix and wherein the composition is adapted to release the prostaglandin analog at therapeutic levels to the eye for at least one month. 
     
     
         66 . The composition of  claim 65 , wherein the composition is configured as a medical device. 
     
     
         67 . The composition of  claim 65 , wherein the composition is configured to be placed in contact with tear fluid. 
     
     
         68 . The composition of  claim 65 , wherein composition is configured to be placed between sclera and conjunctiva of the eye. 
     
     
         69 . The composition of  claim 65 , wherein the prostaglandin analog is latanoprost. 
     
     
         70 . The composition of  claim 65 , wherein the prostaglandin analog is bimatoprost. 
     
     
         71 . The composition of  claim 65 , wherein the polymer matrix comprises silicone. 
     
     
         72 . The composition of  claim 65 , wherein the polymer matrix comprises acrylates, polyethylenes, polyurethane, polyurethane, hydrogel, polyester, polypropylene, polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), polyether ether ketone (PEEK), nylon, extruded collagen, polymer foam, silicone rubber, polyethylene terephthalate, ultra high molecular weight polyethylene, polycarbonate urethane, polyurethane, polyimides, stainless steel, nickel-titanium alloy, titanium, stainless steel, or cobalt-chrome alloy. 
     
     
         73 . The composition of  claim 65 , wherein the polymer matrix comprises hydrogel, polyglycolic acid (PGA), polylactic acid (PLA), poly(L-lactic acid) (PLLA), poly(L-glycolic acid) (PLGA), polyglycolide, poly-L-lactide, poly-D-lactide, poly(amino acids), polydioxanone, polycaprolactone, polygluconate, polylactic acid-polyethylene oxide copolymers, modified cellulose, collagen, polyorthoesters, polyhydroxybutyrate, polyanhydride, polyphosphoester, poly(alpha-hydroxy acid) or combinations thereof.