Method for producing a bioactive surface on an endoprosthesis or on the balloon of a balloon catheter

Abstract

A balloon with a bioactive surface is prepared by softening the surface of the balloon. The surface of the balloon is moistened with a solution of an active ingredient and the solvent is separated from the active ingredient. The solvent can be a water-miscible solvent.

What is claimed is: 
     
         1 . A balloon of a balloon catheter that comprises a bioactive surface, the bioactive surface prepared by:
 softening a surface of the balloon;   wetting the surface of the balloon with a solution of an active ingredient in a solvent;   separating the solvent from the active ingredient;   wherein the surface of the balloon is softened with a water-miscible solvent;   wherein the surface of the balloon is softened with the solution of the active ingredient;   wherein the surface of the balloon comprises a polymer.   
     
     
         2 . The balloon according to  claim 1 , wherein the solvent is dimethyl sulfoxide (DMSO), dioxane, dimethyl formamide (DMF), tetrahydrofuran (THF), methylene chloride or chloroform. 
     
     
         3 . The balloon according to  claim 1 , wherein the balloon consists of a polymer. 
     
     
         4 . The balloon according to  claim 3 , wherein the balloon consists of nylon or of a nylon Pebax mixture. 
     
     
         5 . The balloon according to  claim 1 , wherein the solvent of the solution of the active ingredient is miscible with water, wherein the active ingredient has a solubility of maximally 0.9 mg/ml in distilled water; and wherein the solvent of the solution is separated from the active ingredient in that the wetted endoprosthesis or the wetted balloon is immersed in water, wherein the active ingredient that is insoluble in water precipitates and partially deposits on the surface of the endoprosthesis or the surface of the balloon. 
     
     
         6 . The balloon according to  claim 1 , wherein the surface of the balloon is functionally coated with a polymer layer prior to softening, wetting, and separating. 
     
     
         7 . The balloon according to  claim 1 , wherein the active ingredient is selected from the group consisting of tretinoin, tretinoin derivatives, orphan receptor agonists, elafin derivatives, corticosteroids, steroid hormones, paclitaxel, taxol, taxol derivatives, rapamune, tacrolimus, hydrophobic proteins, and substances that change cell proliferation. 
     
     
         8 . The balloon according to  claim 7 , wherein the steroid hormones are selected from methyl prednisolone, dexamethasone and estradiol. 
     
     
         9 . The balloon according to  claim 7 , wherein a surface area of the balloon is enlarged before softening. 
     
     
         10 . The balloon according to  claim 9 , wherein the surface area is mechanically, thermally, or chemically enlarged. 
     
     
         11 . The balloon according to  claim 1 , wherein the surface area of the balloon is enlarged by structuring or profiling before softening. 
     
     
         12 . The balloon according to  claim 11 , wherein structuring or profiling is carried out by roughening. 
     
     
         13 . The balloon according to  claim 10 , wherein the surface area produced by mechanically, thermally, or chemically enlarging has depressions with a depth of 5-50 μm and a width of 5-50 μm. 
     
     
         14 . A balloon catheter comprising a balloon according to  claim 1 .