Drug releasing coatings for medical devices

Abstract

Balloon catheters, methods for preparing balloon catheters, and uses of balloon catheters are disclosed. The balloon catheter includes an elongate member, an expandable balloon, and a coating layer overlying an exterior surface of the expandable balloon. The coating layer includes a total drug load of a hydrophobic therapeutic agent and a combination of additives including a first additive and a second additive. The hydrophobic therapeutic agent is paclitaxel, rapamycin, or paclitaxel and rapamycin. The first additive is a surfactant. The second additive is a chemical compound having one or more hydroxyl, amino, carbonyl, carboxyl, acid, amide, or ester groups.

What is claimed is: 
     
         1 . A balloon catheter for delivering a therapeutic agent to target site in a blood vessel, the balloon catheter comprising:
 a coating layer overlying an exterior surface of a balloon, the coating layer comprising a therapeutic agent and at least one first additive, wherein:
 the therapeutic agent is selected from the group consisting of paclitaxel, rapamycin, beta-lapachone, biologically active vitamin D, and combinations thereof; and 
 the at least one first additive comprises a PEG fatty ester selected from the group consisting of PEG laurates, PEG oleates, PEG stearates, PEG glyceryl laurates, PEG glyceryl oleates, PEG glyceryl stearates, PEG sorbitan monolaurates, PEG sorbitan monooleates, PEG sorbitan stearates, PEG sorbitan laurates, PEG sorbitan oleates, PEG sorbitan palmitates, and combinations thereof; and 
   a biocompatible polymer.   
     
     
         2 . The balloon catheter of  claim 1 , wherein the biocompatible polymer is present in an adherent layer. 
     
     
         3 . The balloon catheter of  claim 2 , wherein the adherent layer is positioned between the coating layer and the exterior surface of the balloon. 
     
     
         4 . The balloon catheter of  claim 1 , wherein the biocompatible polymer is selected from the group consisting of polyolefins, polyisobutylene, ethylene-I-olefin copolymers, acrylic polymers, polyvinyl chloride, polyvinyl methyl ether, polyvinylidene fluoride, polyvinylidene chloride, polyacrylonitrile, polyvinyl ketones, polystyrene, polyvinyl acetate, ethylene-methyl methacrylate copolymers, acrylonitrile-styrene copolymers, ABS resins, Nylon 12, polycaprolactone, epoxy resins, polyurethanes, rayon-triacetate, cellulose, cellulose acetate, cellulose butyrate, cellophane, cellulose nitrate, cellulose propionate, cellulose ethers, carboxymethyl cellulose, chitins, polylactic acid, polyglycolic acid, polylactic acid-polyethylene oxide copolymers, silicones, ethylene vinyl acetate copolymers, EPDM rubbers, and mixtures and block copolymers thereof. 
     
     
         5 . The balloon catheter of  claim 2 , wherein the adherent layer does not contain a therapeutic agent. 
     
     
         6 . The balloon catheter of  claim 1 , wherein the at least one first additive is selected from the group consisting of PEG-20 sorbitan monolaurate, PEG-20 sorbitan monopalmitate, PEG-20 sorbitan monostearate, PEG-20 sorbitan monooleate, and combinations thereof. 
     
     
         7 . The balloon catheter of  claim 1 , wherein the at least one first additive is selected from the group consisting of PEG-20 sorbitan monolaurate, PEG-20 sorbitan monooleate, and combinations thereof. 
     
     
         8 . The balloon catheter of  claim 1 , wherein the coating layer further comprises a second additive selected from the group consisting of polyglyceryl-10 oleate, octoxynol-9, p-isononylphenoxypolyglycidol, Tyloxapol, niacinamide, nicotinic acid, thiamine hydrochloride, 2-pyrrolidone-5-carboxylic acid, gluconolactone, sorbitol, meglumine, lactobionic acid, N-octanoyl-N-methylglucamine, lactic acid, gensitic acid, diethanolamine, and combinations thereof. 
     
     
         9 . The balloon catheter of  claim 8 , wherein the second additive is selected from the group consisting of polyglyceryl-10 oleate, p-isononylphenoxypolyglycidol, gluconolactone, sorbitol, lactobionic acid, N-octanoyl-N-methylglucamine, and combinations thereof. 
     
     
         10 . The balloon catheter of  claim 8 , wherein the second additive is selected from the group consisting of gluconolactone, sorbitol, lactobionic acid, N-octanoyl-N-methylglucamine, and combinations thereof. 
     
     
         11 . The balloon catheter of  claim 8 , wherein the second additive is selected from the group consisting of gluconolactone, sorbitol, and combinations thereof. 
     
     
         12 . The balloon catheter of  claim 8 , wherein the at least one first additive is PEG-20 sorbitan monolaurate and the second additive is selected from the group consisting of gluconolactone, sorbitol, lactobionic acid, N-octanoyl-N-methylglucamine, and combinations thereof. 
     
     
         13 . The balloon catheter of  claim 8 , wherein the at least one first additive is PEG-20 sorbitan monolaurate, and the second additive is selected from the group consisting of gluconolactone, sorbitol and combinations thereof. 
     
     
         14 . The balloon catheter of  claim 8 , wherein the therapeutic agent is paclitaxel, the at least one first additive is PEG-20 sorbitan monolaurate, and the second additive is selected from the group consisting of gluconolactone, sorbitol, and combinations thereof. 
     
     
         15 . The balloon catheter of  claim 8 , wherein the therapeutic agent is paclitaxel, the at least one first additive is PEG-20 sorbitan monolaurate, and the second additive is gluconolactone. 
     
     
         16 . The balloon catheter of  claim 8 , wherein the therapeutic agent is paclitaxel, the at least one first additive is PEG-20 sorbitan monolaurate, and the second additive is sorbitol. 
     
     
         17 . The balloon catheter of claim  209 , wherein the coating layer further comprises an antioxidant. 
     
     
         18 . The balloon catheter of claim  209 , wherein the concentration of the therapeutic agent in the coating layer is from 1 to 20 μg/mm2. 
     
     
         19 . The balloon catheter of claim  209 , wherein the ratio by weight of the at least one first additive to the therapeutic agent in the coating layer is from about 0.1 to 5. 
     
     
         20 . The balloon catheter of claim  209 , wherein the at least one first additive is not a therapeutic agent.