Drug coating with topcoat

Abstract

A coating and method for a coating an implantable device or prostheses are disclosed. The coating includes an undercoat of polymeric material containing an amount of biologically active material, particularly heparin, dispersed therein. The coating further includes a topcoat which covers less than the entire surface of the undercoat and wherein the topcoat comprises a polymeric material substantially free of pores and porosigens. The polymeric material of the topcoat can be a biostable, biocompatible material which provides long term non-thrombogenicity to the device portion during and after release of the biologically active material.

1 - 50 . (canceled)  
     
     
         51 . A method of making a medical device for delivery of a biologically active material into a blood vessel of a patient comprising: 
 providing a metallic intravascular stent that comprises an open lattice sidewall structure and being designed for permanent implantation into the blood vessel;    applying a first quantity of a first polymer composition to at least a portion of said stent and conforming the first polymer composition to said open lattice sidewall structure so as to preserve the open lattice sidewall structure of said stent, wherein said first polymer composition comprises a first biostable polymer and a biologically active material; and    applying a second quantity of a second polymer composition to at least a portion of said first quantity and conforming the second polymer composition to said stent so as to preserve the open lattice sidewall structure of said stent, wherein said second polymer composition comprises a second biostable polymer that is different from said first biostable polymer, and wherein said second polymer composition is non-thrombogenic and substantially free of the biologically active material or other elutable material,    wherein when in use, the biologically active material is released from the stent to the blood vessel at a first rate that is different from a second rate, wherein the second rate is the rate of release of the same biologically active material from the stent had the second quantity of the second polymer composition not been applied to the first quantity of the first polymer composition.    
     
     
         52 . The method of  claim 51 , wherein the first polymer composition and the second polymer composition are applied by dipping, spraying, or a combination thereof.  
     
     
         53 . The method of  claim 51 , further comprising curing the first polymer composition and/or the second polymer composition.  
     
     
         54 . The method of  claim 53 , further comprising subjecting the cured polymer composition(s) to a postcure process.  
     
     
         55 . The method of  claim 54 , wherein the postcure process comprises inert gas plasma treatment, sterlization, gamma radiation, ETO treatment, electron beam treatment, electron steam treatment, or a combination thereof.  
     
     
         56 . The method of  claim 51 , wherein the metallic intravascular stent is a stainless steel intravascular stent.  
     
     
         57 . The method of  claim 51 , wherein the first quantity of first polymer composition is different from the second quantity of second polymer composition.  
     
     
         58 . The method of  claim 51 , wherein the first biostable polymer comprises a hydrophobic elastomeric material, an ethylene vinyl acetate copolymer material, or a mixture thereof.  
     
     
         59 . The method of  claim 51 , wherein the biologically active material is an antithrobotic agent, anticoagulant, antibiotic, antiplatelet agent, thrombolytic agent, antiproliferative agent, steroidal antiinflammatory agent, nonsteroidal antiinflammatory agent, agent that inhibits hyperplasia, smooth muscle cell inhibitor, growth factor, growth factor inhibitor, cell adhesion inhibitor, cell adhesion promoter, drug that enhances the formation of healthy neointimal tissue, or a mixture thereof.  
     
     
         60 . The method of  claim 51 , wherein the biologically active material is an antibiotic.  
     
     
         61 . The method of  claim 51 , wherein the biologically active material inhibits smooth muscle cell.  
     
     
         62 . The method of  claim 51 , wherein the biologically active material inhibits restenosis.  
     
     
         63 . The method of  claim 51 , wherein the second biostable polymer remains non-thrombogenic during and after release of the biologically active material.  
     
     
         64 . The method of  claim 51 , wherein the stent releases the biologically active material over a period of time.  
     
     
         65 . The method of  claim 51 , wherein the medical device is useful for treating or preventing restenosis.  
     
     
         66 . A method of making a medical device for delivery of a biologically active material into a blood vessel of a patient comprising: 
 providing a metallic intravascular stent that comprises an open lattice sidewall structure and being designed for permanent implantation into the blood vessel;    applying a first quantity of a first polymer composition to at least a portion of said stent and conforming the first polymer composition to said open lattice sidewall structure so as to preserve the open lattice sidewall structure of said stent, wherein said first polymer composition comprises an ethylene vinyl acetate copolymer material and an antibiotic; and    applying a second quantity of a second polymer composition to at least a portion of said first quantity and conforming the second polymer composition to said stent so as to preserve the open lattice sidewall structure of said stent, wherein said second polymer composition comprises a second biostable polymer that is different from the ethylene vinyl acetate copolymer material of said first polymer composition, and wherein said second polymer composition is non-thrombogenic and substantially free of the antibiotic of the first polymer composition or other elutable material,    wherein when in use, the antibiotic is released from the stent to the blood vessel at a first rate that is different from a second rate, wherein the second rate is the rate of release of the same antibiotic from the stent had the second quantity of the second polymer composition not been applied to the first quantity of the first polymer composition.    
     
     
         67 . The method of  claim 66 , wherein the first polymer composition and the second polymer composition are applied by dipping, spraying, or a combination thereof.  
     
     
         68 . The method of  claim 66 , further comprising curing the first polymer composition and/or the second polymer composition.  
     
     
         69 . The method of  claim 68 , further comprising subjecting the cured polymer composition(s) to a postcure process.  
     
     
         70 . The method of  claim 69 , wherein the postcure process comprises inert gas plasma treatment, sterlization, gamma radiation, ETO treatment, electron beam treatment, electron steam treatment, or a combination thereof.  
     
     
         71 . The method of  claim 66 , wherein the metallic intravascular stent is a stainless steel intravascular stent.  
     
     
         72 . The method of  claim 66 , wherein the first quantity of first polymer composition is different from the second quantity of second polymer composition.  
     
     
         73 . The method of  claim 66 , wherein the antibiotic inhibits smooth muscle cell.  
     
     
         74 . The method of  claim 66 , wherein the antibiotic inhibits restenosis.  
     
     
         75 . The method of  claim 66 , wherein the second biostable polymer remains non-thrombogenic during and after release of the antibiotic.  
     
     
         76 . The method of  claim 66 , wherein the stent releases the antibiotic over a period of time.  
     
     
         77 . The method of  claim 66 , wherein the medical device is useful for treating or preventing restenosis.