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.

1 .- 21 . (canceled) 
     
     
         22 . A catheter balloon having a surface and composition applied thereto, wherein the composition comprises: at least one lipophilic anti-hyperplastic agent selected from paclitaxel, heparin, prostacyclins, colchicine, and rapamycin; wherein said balloon surface does not contain a pharmacological polymer, and wherein said composition is of a form suitable for administration into a blood vessel section; wherein the composition contains a solubility promoter that does not form micelles. 
     
     
         23 . The catheter balloon according to claim  1 , wherein the solubility promoter is ethanol. 
     
     
         24 . The catheter balloon according to claim  1 , wherein said at least one lipophilic anti-hyperplastic agent is rapamycin. 
     
     
         25 . The catheter balloon according to claim  1 , wherein said at least one lipophilic anti-hyperplastic agent is paclitaxel. 
     
     
         26 . The catheter balloon according to claim  1 , wherein said composition further comprises an iodine-containing X-ray contrast agent. 
     
     
         27 . The catheter balloon according to claim  1 , wherein said composition further comprises a coagulation inhibitor, a platelet aggregation inhibitor, an enzyme inhibitor, and/or a metal chelator. 
     
     
         28 . The catheter balloon according to claim  1 , wherein said at least one lipophilic anti hyperplastic agent irreversibly or reversibly binds to tissue at a minimum percentage of 10%. 
     
     
         29 . A method for restenosis prevention in a patient, comprising administering to said patient a composition from the catheter balloon according to claim  1 . 
     
     
         30 . A catheter balloon having a surface and a coating applied thereto wherein said coating is a dried layer obtained from a solution consisting essentially of: at least one lipophilic anti-hyperplastic agent selected from paclitaxel, heparin, prostacyclins, colchicine, and rapamycin; at least one solvent; optionally at least one iodine-containing X-ray contrast agent; and optionally a coagulation inhibitor, a platelet aggregation inhibitor, an enzyme inhibitor, and/or a calcium chelator; wherein said balloon surface does not contain a pharmacological polymer; and wherein the composition contains a solubility promoter that does not form micelles. 
     
     
         31 . The catheter balloon according to claim  10 , wherein said at least one lipophilic anti-hyperplastic agent is rapamycin. 
     
     
         32 . The catheter balloon according to claim  10 , wherein said at least one lipophilic anti-hyperplastic agent is paclitaxel.