Drug releasing coatings for medical devices

Abstract

Medical device are provided for delivering a therapeutic agent to a tissue. The medical device has a layer overlying the exterior surface of the medical device. The layer contains a therapeutic agent and an additive. In certain embodiments, the additive has a hydrophilic part and a drug affinity part, wherein the drug affinity part is at least one of a hydrophobic part, a part that has an affinity to the therapeutic agent by hydrogen bonding, and a part that has an affinity to the therapeutic agent by van der Waals interactions. In embodiments, the additive is water-soluble. In further embodiments, the additive is at least one of a surfactant and a chemical compound, and the chemical compound has a molecular weight of from 80 to 750 or has more than four hydroxyl groups.

1 - 18 . (canceled) 
     
     
         19 . A medical device for delivering a therapeutic agent to a tissue, the medical device comprising a medical device coating overlying external surfaces of the medical device, wherein:
 the medical device coating comprises:
 a drug coating layer containing a first therapeutic agent dispersed therein, the first therapeutic agent being chosen from paclitaxel, rapamycin, daunorubicin, doxorubicin, lapachone, vitamin D2, vitamin D3, or combinations thereof; and, 
 an adherent layer comprised of a polymer chosen from polyolefins, polyisobutylene, ethylene-α-olefin copolymers, acrylic polymers and copolymers, polyvinyl chloride, polyvinyl methyl ether, polyvinylidene fluoride and polyvinylidene chloride, polyacrylonitrile, polyvinyl ketones, polystyrene, polyvinyl acetate, ethylene-methyl methacrylate copolymers, acrylonitrile-styrene copolymers, ABS resins, Nylon 12 and its block copolymers, polycaprolactone, polyoxymethylenes, polyethers, 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, polyethylene glycol, polypropylene glycol, polyvinyl alcohol, and mixtures and block copolymers thereof. 
   
     
     
         20 . The medical device of  claim 19 , wherein the first therapeutic agent is rapamycin, paclitaxel or a combination thereof. 
     
     
         21 . The medical device of  claim 19 , wherein the polymer is polyvinylidene fluoride. 
     
     
         22 . The medical device of  claim 19 , wherein the drug coating layer further comprises an additive chosen from polyethylene glycol (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, or combinations thereof. 
     
     
         23 . The medical device of  claim 22 , wherein the drug coating layer further comprises a second additive chosen from poly(ethylene glycol) oligomers, poly(propylene glycol) oligomers, or combinations thereof; 
     
     
         24 . The medical device of  claim 23 , wherein the second additive is chosen from PEG-20 sorbitan monolaurate, PEG-20 sorbitan monooleate, or combinations thereof. 
     
     
         25 . The medical device of  claim 24 , wherein the second additive is chosen from a di(ethylene glycol), tri(ethylene glycol), tetra(ethylene glycol), penta(ethylene glycol), di(propylene glycol), tri(propylene glycol), tetra(propylene glycol), and penta(propylene glycol). 
     
     
         26 . The medical device of  claim 19 , further comprising a top layer, wherein the top layer comprises:
 a second therapeutic agent chosen from paclitaxel, rapamycin, daunorubicin, doxorubicin, lapachone, vitamin D2, vitamin D3, or combinations thereof; and   a third additive.   
     
     
         27 . The medical device of  claim 26 , wherein the third additive is chosen from PEG-20 sorbitan monolaurate, PEG-20 sorbitan monopalmitate, PEG-20 monostearate, PEG-20 sorbitan monooleate, polyglyceryl oleate, polyethylene oxide, polyethylene glycol, polyvinyl pyrrolidone, L-ascorbic acid and its salts, D-glucoascorbic acid and its salts, tromethamine, triethanolamine, diethanolamine, meglumine, glucamine, amine alcohols, glucoheptonic acid, gluconic acid, hydroxy ketones, hydroxy lactones, gluconolactone, glucoheptonolactone, glucooctanoic lactone, gulonic acid lactone, mannoic lactone, ribonic acid lactone, lactobionic acid, glucosamine, glutamic acid, benzyl alcohol, benzoic acid, hydroxybenzoic acid, propyl 4-hydroxybenzoate, lysine acetate salt, gentisic acid, lactitol, sinapic acid, vanillic acid, vanillin, methyl paraben, propyl paraben, sorbitol, cyclodextrin, (2-hydroxypropyl)-cyclodextrin, acetaminophen, ibuprofen, retinoic acid, lysine acetate, gentisic acid, catechin, catechin gallate, tiletamine, ketamine, propofol, and combinations thereof. 
     
     
         28 . The medical device of  claim 19 , wherein the medical device coating further comprises sorbitol, xylitol, 2-ethoxyethanol, galactose, glucose, mannose, xylose, sucrose, lactose, maltose, gluconolactone, lactobionic acid, or combinations thereof. 
     
     
         29 . The medical device of  claim 25 , wherein the second additive is chosen from a penta(ethylene glycol), di(propylene glycol), tri(propylene glycol), tetra(propylene glycol), and penta(propylene glycol). 
     
     
         30 . The medical device of  claim 19 , wherein the medical device is a balloon catheter, a perfusion balloon catheter, an infusion catheter such as distal perforated drug infusion tube, a perforated balloon, spaced double balloon, porous balloon, and weeping balloon, a cutting balloon catheter, a scoring balloon catheter, a laser catheter, an atherectomy device, a debulking catheter, a stent, a filter, a stent graft, a covered stent, a patch, a wire, or a valve. 
     
     
         31 . The medical device of  claim 19 , wherein the concentration of the first therapeutic agent is from 1 μg/mm 2  to 20 μg/mm 2 . 
     
     
         32 . The medical device of  claim 19 , wherein the tissue includes tissue of one of coronary vasculature, peripheral vasculature, cerebral vasculature, esophagus, airways, sinus, trachea, colon, biliary tract, urinary tract, prostate, and brain passages.