Medical devices for therapeutic agent delivery with polymeric regions that contain copolymers having both soft segments and uniform length hard segments

Abstract

Implantable or insertable medical devices are described, which include one or more polymeric regions and one or more therapeutic agents. The polymeric regions, which regulate the release of one or more therapeutic agent from the medical device, contain copolymer molecules, each of which includes one or more soft segments and one or more uniform hard segments (e.g., polyamide segments that do not vary in length from molecule to molecule, among others).

1 . An implantable or insertable medical device comprising a substrate, a polymeric region disposed over said substrate, and a therapeutic agent disposed within or beneath said polymeric region, said polymeric region regulating the release of said therapeutic agent from said medical device and comprising copolymer molecules each comprising a soft segment and a uniform hard segment. 
     
     
         2 . The medical device of  claim 1 , wherein said copolymer molecules each comprise a plurality of uniform hard segments. 
     
     
         3 . The medical device of  claim 1 , wherein said copolymer molecules each comprise a plurality of soft segments. 
     
     
         4 . The medical device of  claim 1 , wherein at least 25 wt % of said copolymer molecules have hard segments of uniform length. 
     
     
         5 - 16 . (canceled) 
     
     
         17 . The medical device of  claim 1 , wherein said poly(ether amide) copolymer molecules each comprises a dendrimer segment. 
     
     
         18 . (canceled) 
     
     
         19 . The medical device of  claim 1 , comprising a plurality of different therapeutic agents. 
     
     
         20 . The medical device of  claim 1 , wherein said therapeutic agent is disposed beneath said polymeric region. 
     
     
         21 . The medical device of  claim 1 , wherein said therapeutic agent is disposed within said polymeric region. 
     
     
         22 . The medical device of  claim 1 , wherein said polymeric region comprises said therapeutic agent covalently linked to said copolymer molecules. 
     
     
         23 . The medical device of  claim 22 , wherein said therapeutic agent is covalently linked to said copolymer molecules via a biodegradable linkage. 
     
     
         24 . (canceled) 
     
     
         25 . The medical device of  claim 1 , wherein said polymer region further comprises an additional polymer in addition to said copolymer. 
     
     
         26 . The medical device of  claim 1 , wherein said therapeutic agent is covalently linked to said additional polymer. 
     
     
         27 . The medical device of  claim 26 , wherein said therapeutic agent is covalently linked to said additional polymer via a biodegradable linkage. 
     
     
         28 . (canceled) 
     
     
         29 . The medical device of  claim 25 , wherein said additional polymer comprises a polyamide segment. 
     
     
         30 . The medical device of  claim 25 , wherein said additional polymer comprises a polyamide segment that matches said uniform polyamide segment. 
     
     
         31 . The medical device of  claim 1 , wherein said medical device is selected from a guide wire, a balloon, a vena cava filter, a catheter, a stent, a stent graft, a vascular graft, a cerebral aneurysm filler coil, a myocardial plug, a heart valve, a vascular valve, and a tissue engineering scaffold. 
     
     
         32 . The medical device of  claim 1 , wherein said device comprises a plurality of polymeric regions. 
     
     
         33 - 48 . (canceled) 
     
     
         49 . The medical device of  claim 1 , comprising a hybrid film between said substrate and said polymeric region, said hybrid film comprising a polymeric phase and a ceramic phase.