Coated implantable medical device

Abstract

Bioactive-coated medical devices are provided, including coated vascular stents. The medical device coating can include a coating layer posited over at least a portion of the medical device surface, and can include a butyl methacrylate polymer or an ethylene-vinyl acetate copolymer in combination with a bioactive material that can function as both an immunosuppressive agent and an antiproliferative agent. Optionally, multilayer coatings can further include an adhesion promoting layer comprising parylene positioned between the coating layer and the medical device surface, a porous layer comprising butyl methacrylate positioned over at least a portion of the coating layer, or both. The coating layer preferably comprises between about 0.5 and 2.0 μg/mm 2 of the bioactive material on the outer surface of the medical device. The bioactive material can be absorbed into the coating layer, which can have a thickness of between about 0.5 μm to about 5 μm.

1 . A coated medical device, comprising: 
 a structure adapted for introduction into a patient, the structure having at least one surface;    a coating layer posited over the at least one surface of the structure, the coating layer comprising an ethylene-vinyl acetate copolymer and a bioactive material, the bioactive material comprising an immunosuppressive agent.    
     
     
         2 . The coated medical device of  claim 1 , wherein the bioactive material is both an immunosuppressive agent and an antiproliferative agent.  
     
     
         3 . The coated medical device of  claim 1 , wherein the coating layer further comprises butyl methacrylate.  
     
     
         4 . The coated medical device of  claim 1 , wherein the coating layer comprises between about 1-5 μg/mm 2  of the bioactive material on the surface.  
     
     
         5 . The coated medical device of  claim 1 , wherein the bioactive material is absorbed into the coating layer.  
     
     
         6 . The coated medical device of  claim 1 , wherein the coating layer has a thickness of between about 0.5 μm to about 5 μm.  
     
     
         7 . The coated medical device of  claim 1 , wherein the structure is a vascular stent comprising a biocompatible metal.  
     
     
         8 . The coated medical device of  claim 1 , wherein the structure is a vascular stent comprising stainless steel and having an outer surface and a lumen surface; wherein the at least one surface contacting the coating layer is the outer surface of the vascular stent; and wherein the coating layer comprises between about 0.5 and 2.0 μg/mm 2  of the bioactive material in the coating layer posited on the outer surface.  
     
     
         9 . The coated medical device of  claim 1 , wherein the coated medical device further comprises an adhesion promoting layer comprising parylene positioned between the coating layer and the at least one surface of the structure.  
     
     
         10 . The coated medical device of  claim 1 , wherein the coated medical device further comprises a porous layer comprising butyl methacrylate positioned over at least a portion of the coating layer.  
     
     
         11 . The coated medical device of  claim 1 , wherein the coated medical device further comprises: 
 an adhesion promoting layer comprising parylene positioned between the coating layer and the at least one surface of the structure; and    a porous layer comprising butyl methacrylate positioned over at least a portion of the coating layer; and    wherein the structure is configured as a vascular stent having a stainless steel outer surface in contact with the adhesion promoting layer, at least a portion of the coating layer is positioned in contact with the adhesion promoting layer and the porous layer, the coating layer comprising an ethylene-vinyl acetate copolymer and a butyl methacrylate polymer in contact with the bioactive agent, and the bioactive agent is both an immunosuppressive agent and an antiproliferative agent.    
     
     
         12 . A coated medical device, comprising: 
 a structure adapted for introduction into a patient, the structure having at least one surface;    a coating layer posited over the at least one surface of the structure, the coating layer comprising a butyl methacrylate polymer and a bioactive material that is both an immunosuppressive agent and an antiproliferative agent.    
     
     
         13 . The coated medical device of  claim 12 , wherein the coating layer further comprises an ethylene-vinyl acetate copolymer.  
     
     
         14 . The coated medical device of  claim 12 , wherein the coating layer comprises between about 0.5 and 2.0 μg/mm 2  of the bioactive material on the at least one surface.  
     
     
         15 . The coated medical device of  claim 12 , wherein the coated medical device further comprises an adhesion promoting layer comprising parylene positioned between the coating layer and the at least one surface of the structure.  
     
     
         16 . The coated medical device of  claim 12 , wherein the coated medical device further comprises a porous layer comprising butyl methacrylate positioned over at least a portion of the coating layer.  
     
     
         17 . A coated vascular stent, comprising: 
 a vascular stent adapted for introduction into a patient, the structure having an outer surface and a lumen surface;    an adhesion promoting layer comprising parylene positioned between the coating layer and the outer surface;    a coating layer posited over at least a portion of the adhesion promoting layer, the coating layer comprising a butyl methacrylate polymer, an ethylene-vinyl acetate copolymer and a bioactive material that is both an immunosuppressive agent and an antiproliferative agent; and    a porous layer comprising butyl methacrylate positioned over at least a portion of the coating layer.    
     
     
         18 . The coated vascular stent of  claim 17 , wherein the coating layer comprises between about 0.5 and 2.0 μg/mm 2  of the bioactive material on the outer surface of the coated vascular stent.  
     
     
         19 . The coated medical device of  claim 17 , wherein the bioactive material is absorbed into the coating layer.  
     
     
         20 . The coated medical device of  claim 17 , wherein the coating layer has a thickness of between about 0.5 μm to about 5 μm.