Drug Eluting Implantable Medical Device With Hemocompatible And/Or Prohealing Topcoat

Abstract

The present invention relates to implantable medical devices coated with polymer having hemocompatible and/or prohealing moieties appended thereto and to their use in the treatment of vascular diseases.

1 .- 20 . (canceled) 
     
     
         21 . An implantable medical device, comprising:
 a device body;   an optional primer layer disposed over the device body; and   a drug reservoir layer disposed over the device body or the primer layer, if opted, wherein the drug reservoir layer comprises:   i) a high molecular weight copolymer of lactic acid, L-lactide, D,L-lactide, or meso-lactide with ε-caprolactone or trimethylene carbonate, at least a portion of which is substituted with a pendant hemocompatible and/or a prohealing moiety; or   ii) a blend of a high molecular weight copolymer of lactic acid, L-lactide, D,L-lactide, or meso-lactide with ε-caprolactone or trimethylene carbonate and a low molecular weight copolymer of lactic acid, L-lactide, D,L-lactide, or meso-lactide with ε-caprolactone or trimethylene carbonate at least a portion of which is substituted with a pendant hemocompatible and/or prohealing moiety; or   iii) a high molecular weight copolymer of lactic acid, L-lactide, D,L-lactide, or meso-lactide with ε-caprolactone or trimethylene carbonate, and a topcoat layer comprising a low molecular weight copolymer of lactic acid, L-lactide, D,L-lactide, or meso-lactide with ε-caprolactone or trimethylene carbonate at least a portion of which is substituted with a pendant hemocompatible and/or prohealing moiety;   and   one or more therapeutic agent(s);   wherein the hemocompatible and/or prohealing moiety is a polyhydroxyalkyl moiety.   
     
     
         22 . The implantable medical device of  claim 21 , wherein the drug reservoir layer or the topcoat layer comprising a polyhydroxyalkyl moiety has the formula: 
       
         
           
           
               
               
           
         
         wherein: 
         L comprises a Linker; and, 
         m is from about 0.01 to about 0.99; 
         n is from about 0.99 to about 0.01; and 
         n+m=1. 
       
     
     
         23 . The implantable medical device of  claim 22 , wherein the m is from about 0.5 to about 0.8. 
     
     
         24 . The implantable medical device of  claim 22 , wherein the m is from about 0.65 to about 0.75. 
     
     
         25 . The implantable medical device of  claim 21 , wherein the polyhydroxyalkyl is selected from the group consisting of glycerol, sorbitol, mannitol, a glycol, a polyalkylglycol and a polyglycol. 
     
     
         26 . The implantable medical device of  claim 21 , wherein the drug reservoir layer polymer has a molecular weight from about 50,000 to about 500,000 Daltons. 
     
     
         27 . The implantable medical device of  claim 21 , wherein the drug reservoir layer has a coating thickness from about 1 um to about 10 um. 
     
     
         28 . The implantable medical device of  claim 21 , wherein the drug to polymer wt/wt ratio in the drug reservoir layer is from about 1.0:0.5 to about 1.0:10.0. 
     
     
         29 . The implantable medical device of  claim 21 , wherein the drug dose is about 5-200 microgram/cm 2 . 
     
     
         30 . The implantable medical device of  claim 21 , wherein the drug dose is about 20-100 microgram/cm 2 . 
     
     
         31 . The implantable medical device of  claim 21 , wherein the device is a stent.