Coated medical device

Abstract

A coated medical device (10) including a structure (12) adapted for introduction into a passage or vessel of a patient. The structure is formed of preferably a non-porous base material (14) having a bioactive material layer (18) disposed thereon. The medical device is preferably an implantable stent or balloon (26) of which the bioactive material layer is deposited thereon. The stent can be positioned around the balloon and another layer of the bioactive material posited over the entire structure and extending beyond the ends of the positioned stent. The ends of the balloon extend beyond the ends of the stent and include the bioactive material thereon for delivering the bioactive material to the cells of a vessel wall coming in contact therewith. The balloon further includes a layer of hydrophilic material (58) positioned between the base and bioactive material layers of the balloon.

What is claimed is: 
     
         1 . A medical device suitable for introduction in a patient, comprising:
 a vascular stent comprising a biocompatible metal or metal alloy base material;   a coating comprising a bioactive material for preventing restenosis of a blood vessel posited directly on a surface of the metal or metal alloy base material, the surface having a texture sufficient for adhesion of the bioactive material to the surface; and   wherein the bioactive material for preventing restenosis is not contained within or covered by a containment layer.   
     
     
         2 . The medical device of  claim 1 , wherein the bioactive material is an antiproliferative agent. 
     
     
         3 . The medical device of  claim 1 , wherein the coating consists essentially of the bioactive material. 
     
     
         4 . The medical device of  claim 1 , wherein the base material comprises at least one of stainless steel, tantalum, titanium, nitinol, gold, platinum, inconel, iridium, silver, tungsten, or an alloy of any of these. 
     
     
         5 . The medical device of  claim 1 , wherein the base material comprises nitinol. 
     
     
         6 . The medical device of  claim 1 , wherein the base material comprises stainless steel. 
     
     
         7 . The medical device of  claim 1 , wherein the texture of the surface has been provided by treating the surface to reduce its roughness. 
     
     
         8 . The medical device of  claim 1 , wherein the texture of the surface has been provided by treating the surface to increase its roughness. 
     
     
         9 . A medical device suitable for introduction in a patient, comprising:
 a vascular stent comprising a biocompatible metal or metal alloy base material;   a coating comprising pactlitaxel posited on a surface of a base material of the vascular stent, wherein the coating adheres directly to the surface of the base material, and wherein the paclitaxel is not contained within or covered by a containment layer.   
     
     
         10 . The medical device of  claim 9 , wherein the coating consists essentially of the paclitaxel. 
     
     
         11 . The medical device of  claim 9 , wherein the base material comprises at least one of stainless steel, tantalum, titanium, nitinol, gold, platinum, inconel, iridium, silver, tungsten, or an alloy of any of these. 
     
     
         12 . The medical device of  claim 9 , wherein the base material comprises nitinol. 
     
     
         13 . The medical device of  claim 10 , wherein the base material comprises nitinol. 
     
     
         14 . A medical device suitable for introduction into a patient, comprising:
 a vascular stent comprising a biocompatible metal or metal alloy base material; and   only a single coating layer on the vascular stent, the coating layer comprising paclitaxel and being posited on a surface of the base material, wherein the coating layer adheres directly to the surface of the base material, and wherein the coating layer is not a time-release layer.   
     
     
         15 . The medical device of  claim 14 , wherein the coating layer consists essentially of the paclitaxel. 
     
     
         16 . The medical device of  claim 14 , wherein the base material comprises at least one of stainless steel, tantalum, titanium, nitinol, gold, platinum, inconel, iridium, silver, tungsten, or an alloy of any of these. 
     
     
         17 . The medical device of  claim 14 , wherein the base material comprises nitinol. 
     
     
         18 . The medical device of  claim 15 , wherein the base material comprises nitinol. 
     
     
         19 . A method of preparing a medical device suitable for introduction into a patient, comprising:
 providing a vascular stent comprising a base material having a surface;   providing a solution comprising paclitaxel and a solvent;   applying the solution directly to the surface of the base material;   evaporating the solvent to leave a coating comprising paclitaxel on the surface, the surface having a texture sufficient for adhesion of the coating to the surface; and   wherein the method is further characterized in that the paclitaxel is not contained within or covered by a containment layer.   
     
     
         20 . The method of  claim 19 , wherein the base material comprises nitinol. 
     
     
         21 . A method for treating a patient, comprising:
 implanting in a blood vessel of the patient a vascular stent comprising a biocompatible metal or metal alloy base material and only a single coating layer on the vascular stent, the coating layer comprising paclitaxel and being posited directly on a surface of the base material, wherein the surface of the base material has a texture sufficient for adhesion of the coating to the surface, and wherein the coating layer is not a time-release layer.