Coated implantable medical device

Abstract

A coated implantable medical device includes a structure adapted for introduction into the vascular system, esophagus, trachea, colon, biliary tract, or urinary tract; at least one coating layer posited on one surface of the structure; and at least one layer of a bioactive material posited on at least a portion of the coating layer. Preferably the structure is a stent graft.

1 . A medical device, comprising:
 a structure having at least one surface and being composed of a base material;   at least one coating layer comprising a polymer posited on the at least one surface of the structure; and   at least one layer comprising a first bioactive material posited over at least a portion of the at least one coating layer, wherein the first bioactive material is selected from the group consisting of vasodilators, antimicrobials, antibiotics, antimitotics, antiproliferatives, antisecretory agents, non-steroidal antiinflammatory drugs, immunosuppressive agents, growth factor antagonists, and antioxidants;   wherein said at least one coating layer provides for a controlled release of the first bioactive material.   
     
     
         2 . The medical device of  claim 1 , wherein the polymer is selected from the group consisting of parylene, polyurethanes, silicones and polyesters. 
     
     
         3 . The medical device of  claim 2 , wherein the polymer is a polyurethane. 
     
     
         4 . The medical device of  claim 1 , wherein polymer is selected from the group consisting of polyimide, poly(ethylene oxide), poly(ethylene glycol), poly(propylene oxide), silicone, polytetrafluoroethylene, tetramethyldisiloxane, parylene, parylene derivative, and a polymer of methane. 
     
     
         5 . The medical device of  claim 1 , wherein the polymer is parylene or a parylene derivative. 
     
     
         6 . The medical device of  claim 1 , wherein the structure is a stent. 
     
     
         7 . The medical device of  claim 1 , wherein the at least one layer comprising the first bioactive material is the outermost layer of the medical device. 
     
     
         8 . The medical device of  claim 1 , wherein the at least one layer comprising the first bioactive material further comprises a second bioactive material. 
     
     
         9 . The medical device of  claim 8 , wherein the first bioactive material is paclitaxel or a paclitaxel derivative. 
     
     
         10 . The medical device of  claim 9 , wherein the second bioactive material is an anti-inflammatory agent. 
     
     
         11 . The medical device of  claim 8 , wherein one of the first bioactive material or the second bioactive material is an anti-inflammatory agent. 
     
     
         12 . The medical device of  claim 8 , wherein the first bioactive material and the second bioactive material are co-mixed. 
     
     
         13 . The medical device of  claim 1 , wherein the at least one coating layer comprises a non-porous material. 
     
     
         14 . The medical device of  claim 1  wherein the at least one coating layer has a thickness in a range from 50,000 to 500,000 Angstroms. 
     
     
         15 . The medical device of  claim 1 , wherein the polymer is selected from the group consisting of a polyurethane, silicones, polyesters, polyimide, poly(ethylene oxide), poly(ethylene glycol), poly(propylene oxide), silicone, polytetrafluoroethylene, tetramethyldisiloxane, parylene, and a parylene derivative;
 wherein the medical device is a stent; and   wherein the first bioactive material is paclitaxel or a paclitaxel derivative.   
     
     
         16 . The medical device of  claim 15 , wherein the at least one layer comprising the first bioactive material further comprises a second bioactive material; and wherein the second bioactive material is an anti-inflammatory agent. 
     
     
         17 . The medical device of  claim 16 , wherein the at least one layer of a first bioactive material is the outermost layer of the medical device. 
     
     
         18 . The medical device of  claim 1 , wherein the polymer is selected from the group consisting of polyimide, poly(ethylene oxide), poly(ethylene glycol), poly(propylene oxide), silicone, polytetrafluoroethylene, tetramethyldisiloxane, parylene, and a parylene derivative;
 and   wherein the first bioactive material is paclitaxel or a paclitaxel derivative.   
     
     
         19 . The medical device of  claim 18 , wherein at least one layer comprising the first bioactive material further comprises a second bioactive material; and wherein the second bioactive material is an anti-inflammatory agent.