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 medical device comprising a balloon having a surface; wherein the balloon surface comprises paclitaxel and a low molecular weight matrix substance; and wherein the low molecular weight matrix substance comprises a hydrophilic material. 
     
     
         23 . The medical device of  claim 22  wherein the balloon surface comprising paclitaxel and a low molecular weight matrix substance is a solution of paclitaxel and the low molecular weight hydrophilic material applied to the balloon and dried. 
     
     
         24 . The medical device of  claim 22 , wherein the hydrophilic material is an iodine-containing radiopaque agent. 
     
     
         25 . The medical device of  claim 22  wherein the hydrophilic material comprises a sugar. 
     
     
         26 . The medical device of  claim 25  wherein the sugar comprises a polysaccharide. 
     
     
         27 . The medical device of  claim 26  wherein the sugar comprises dextran. 
     
     
         28 . The medical device of claim  1  wherein the hydrophilic material comprises an alcohol. 
     
     
         29 . The medical device of  claim 28  wherein the alcohol comprises alpha-tocopherol. 
     
     
         30 . The medical device of  claim 22  wherein the hydrophilic material comprises a sugar derivative. 
     
     
         31 . The medical device of  claim 30  wherein the sugar derivative comprises ascorbic acid. 
     
     
         32 . The medical device of  claim 22  wherein said medical device further comprises a stent. 
     
     
         33 . The medical device of  claim 22  wherein the balloon is a folded balloon. 
     
     
         34 . The medical device of  claim 22  wherein the paclitaxel and matrix substance are present as a dry solid on the balloon surface. 
     
     
         35 . The medical device of  claim 22  wherein the concentration of paclitaxel on said surface is up to 5 μg/mm 2 . 
     
     
         36 . The medical device of  claim 22  wherein the low molecular weight matrix substance has a molecular weight of less than 5000 D. 
     
     
         37 . The medical device of  claim 36  wherein the low molecular weight matrix substance has a molecular weight of less than 2000 D. 
     
     
         38 . A medical device comprising a balloon having a surface; wherein the balloon surface comprises paclitaxel and a low molecular weight matrix substance adhered to the balloon surface; and wherein the low molecular weight matrix substance comprises a sugar, an alcohol, or a biocompatible salt. 
     
     
         39 . The device of  claim 38  wherein the substance comprises or consists essentially of dextran. 
     
     
         40 . The device of  claim 38  wherein the substance comprises or consists essentially of alpha-tocopherol. 
     
     
         41 . The device of  claim 38  wherein the substance comprises or consists essentially of dexamethasone sodium phosphate. 
     
     
         42 . The device of  claim 38  wherein the substance comprises or consists essentially of sodium nitroprusside. 
     
     
         43 . The medical device of  claim 38  wherein said medical device further comprises a stent. 
     
     
         44 . The medical device of  claim 38  wherein the balloon is a folded balloon. 
     
     
         45 . The medical device of  claim 38  wherein the balloon surface consists of a material to which the paclitaxel and matrix substance adhere sufficiently well to resist forces required for folding, essentially without damage. 
     
     
         46 . The medical device of  claim 38  wherein the concentration of paclitaxel on said surface is up to 5 μg/mm 2 . 
     
     
         47 . The medical device of  claim 38  wherein the low molecular weight matrix substance has a molecular weight of less than 5000 D. 
     
     
         48 . The medical device of  claim 47  wherein the low molecular weight matrix substance has a molecular weight of less than 2000 D. 
     
     
         49 . A medical device comprising a balloon having a surface; wherein the balloon surface comprises paclitaxel and a low molecular weight inert matrix substance; and wherein the low molecular weight inert matrix substance comprises a hydrophilic material. 
     
     
         50 . The medical device of  claim 49  wherein the balloon surface comprising paclitaxel and a low molecular weight inert matrix substance is a solution of paclitaxel and the low molecular weight hydrophilic material applied to the balloon and dried. 
     
     
         51 . The medical device of  claim 49  wherein the hydrophilic material comprises a sugar. 
     
     
         52 . The medical device of  claim 51  wherein the sugar comprises a polysaccharide. 
     
     
         53 . The medical device of  claim 52  wherein the sugar comprises dextran. 
     
     
         54 . The medical device of  claim 49  wherein the hydrophilic material comprises an iodine containing radiopaque agent. 
     
     
         55 . The medical device of  claim 49  wherein the hydrophilic material comprises an alcohol. 
     
     
         56 . The medical device of  claim 55  wherein the alcohol comprises alpha-tocopherol. 
     
     
         57 . The medical device of  claim 49  wherein the hydrophilic material comprises a sugar derivative. 
     
     
         58 . The medical device of  claim 57  wherein the sugar derivative comprises ascorbic acid. 
     
     
         59 . The medical device of  claim 49  wherein said medical device further comprises a stent. 
     
     
         60 . The medical device of  claim 49  wherein the balloon is a folded balloon. 
     
     
         61 . The medical device of  claim 49  wherein the paclitaxel and matrix substance are present as a dry solid on the balloon surface. 
     
     
         62 . The medical device of  claim 49  wherein the concentration of paclitaxel on said surface is up to 5 μg/mm 2 . 
     
     
         63 . The medical device of  claim 49  wherein the low molecular weight inert matrix substance has a molecular weight of less than 5000 D. 
     
     
         64 . A medical device comprising a balloon having a surface; wherein the balloon surface comprises paclitaxel and a low molecular weight inert matrix substance adhered to the balloon surface; and wherein the low molecular weight inert matrix substance comprises a sugar, an alcohol, or a biocompatible inorganic salt. 
     
     
         65 . The device of  claim 64  wherein the substance comprises or consists essentially of dextran. 
     
     
         66 . The device of  claim 64  wherein the substance comprises or consists essentially of alpha-tocopherol. 
     
     
         67 . The device of  claim 64  wherein the substance comprises or consists essentially of dexamethasone sodium phosphate. 
     
     
         68 . The device of  claim 64  wherein the substance comprises or consists essentially of sodium nitroprusside. 
     
     
         69 . The medical device of  claim 64  wherein said medical device further comprises a stent. 
     
     
         70 . The medical device of  claim 64  wherein the balloon is a folded balloon. 
     
     
         71 . The medical device of  claim 64  wherein the balloon surface consists of a material to which the paclitaxel and inert matrix substance adhere sufficiently well to resist forces required for folding, essentially without damage. 
     
     
         72 . The medical device of  claim 64  wherein the low molecular weight inert matrix substance has a molecular weight of less than 5000 D. 
     
     
         73 . The medical device of  claim 72  wherein the low molecular weight inert matrix substance has a molecular weight of less than 2000 D. 
     
     
         74 . The medical device of  claim 33 , wherein the balloon has preformed longitudinal folds maintaining an inclination to refold after inflation. 
     
     
         75 . The medical device of  claim 74 , wherein the area covered by folds is covered with the paclitaxel and low molecular weight matrix substance.