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 balloon catheter medical device that releases a drug by immediate release for the selective therapy of specific diseased tissue or an organ part to which said drug will bind, comprising such a drug which is lipophilic, water-insoluble and immediately releasable, adhered to a smooth surface of the balloon of said catheter that comes into contact with the diseased tissue or organ part, which adhered drug when pressed against said tissue or organ part at least for a short time, is immediately released into said tissue or organ part, wherein the concentration of said drug on said surface is up to 20 μg/mm 2 . 
     
     
         23 . The device according to  claim 22 , wherein said balloon catheter comprises a stent. 
     
     
         24 . The device according to  claim 23 , wherein the balloon further comprising preformed longitudinal folds is coated with the drug, and the inclination of said folds to refold is not lost after inflation. 
     
     
         25 . The device according to  claim 23 , wherein the balloon is coated with said drug and comprises smooth material to which said drug adheres sufficiently well to resist forces required for folding, essentially without damage. 
     
     
         26 . The device according to  claim 23 , wherein only an area covered by folds is coated with the drug that was dried after application. 
     
     
         27 . The device according to  claim 22 , wherein said balloon catheter does not comprise a stent. 
     
     
         28 . The device according to  claim 22 , wherein the lipophilic drug is an inhibitor of cell proliferation or inflammatory processes, or an antioxidant. 
     
     
         29 . The device according to  claim 28 , wherein the drug used is paclitaxel or other taxane, rapamycin, a sex hormone, a statin, or a prostacyclin. 
     
     
         30 . The device according to  claim 28 , wherein the lipophilic drug is present as a dry solid on the smooth surface of the balloon. 
     
     
         31 . The device according to  claim 22 , wherein the lipophilic drug is embedded in a readily water-soluble matrix substance to achieve good adhesion to the smooth surface of the balloon and improve absorption by the tissue. 
     
     
         32 . The device according to  claim 31 , wherein said substance is a low-molecular weight hydrophilic substance with a molecular weight <5000 D. 
     
     
         33 . A medical device of  claim 32  wherein said drug is paclitaxel and said device is an angioplasty balloon catheter having a smooth balloon surface. 
     
     
         34 . The device according to  claim 22 , wherein the lipophilic drug is adsorbed to particles of or applied to the smooth surface of the balloon with, a low-molecular weight matrix. 
     
     
         35 . The device according to  claim 22 , having a surface additionally coated with a substance that influences the gliding quality of the device or that prevents blood coagulation. 
     
     
         36 . A medical device of  claim 22  wherein said drug is paclitaxel and said device is an angioplasty balloon catheter having a smooth balloon surface. 
     
     
         37 . A method for producing the device according to  claim 22 , comprising applying the lipophilic drug in a solution medium using an immersion, spreading, or spraying process to the smooth surface of the balloon to provide a coating and removing excess media and substances that adhere loosely to the surface. 
     
     
         38 . The method according to  claim 37 , wherein the coating process is carried out repeatedly to achieve a reproducible increase of the drug content using a same solution medium and/or excipient. 
     
     
         39 . The method according to  claim 38 , wherein ethanol is used as the solution medium. 
     
     
         40 . The method according to  claim 37 , wherein the folded balloon is used as a drug carrier and is coated prior to or after sterilization with or without a crimped-on stent. 
     
     
         41 . The method according to  claim 40 , wherein the balloon is coated with the lipophilic drug in unfolded condition and then is folded. 
     
     
         42 . The method according to  claim 37 , wherein a stent is attached prior to or after coating of the balloon. 
     
     
         43 . A method of treating a vascular disease or circulation disturbance comprising administering a device of  claim 22  to affected tissue. 
     
     
         44 . A method of opening a passage in the body comprising administering a device of  claim 22 . 
     
     
         45 . A balloon catheter having folds in its balloon, comprising a lipophilic, water-insoluble drug which binds to tissue, said drug being adhered to a smooth balloon surface in a fashion wherein it is immediately released upon coming into contact with said tissue, wherein a balloon area covered with folds is coated with said drug which has been dried after application, and wherein the concentration of said drug on said surface is up to 20 μg/mm 2 . 
     
     
         46 . The balloon catheter according to  claim 45 , further comprising a stent, a needle or a guiding wire. 
     
     
         47 . The balloon catheter according to  claim 45 , comprising a balloon that, in its finally folded state, is coated with a low-viscosity active agent solution of said drug, by immersing or spraying. 
     
     
         48 . The balloon catheter according to  claim 45 , wherein the lipophilic drug is an inhibitor of cell proliferation or an inflammatory process, or an antioxidant. 
     
     
         49 . The balloon catheter according to  claim 48 , wherein the drug is paclitaxel or other taxane, rapamycin, a sex hormone, a statin, or a prostacyclin. 
     
     
         50 . The balloon catheter according to  claim 48 , wherein the lipophilic drug is present as a dry solid on the surface of the balloon. 
     
     
         51 . The balloon catheter according to  claim 45 , wherein said lipophilic drug is embedded in a readily water-soluble matrix substance to achieve good adhesion to the surface of the balloon and improved absorption by the tissue. 
     
     
         52 . The balloon catheter according to  claim 51 , wherein said substance is a low-molecular weight hydrophilic substance with a molecular weight <5000 D. 
     
     
         53 . A balloon catheter of  claim 52  wherein said drug is paclitaxel and said device is an angioplasty balloon catheter having a smooth balloon surface. 
     
     
         54 . The balloon catheter according to  claim 51 , wherein said substance is a contrast agent. 
     
     
         55 . The balloon catheter according to  claim 54 , wherein said substance is an iodinated X-ray contrast agent. 
     
     
         56 . The balloon catheter according to  claim 45 , wherein said lipophilic drug is adsorbed to a particle or applied to the smooth surface of the balloon with a low-molecular weight substance. 
     
     
         57 . The balloon catheter according to  claim 45 , having a surface additionally coated with a substance that influences the glidability of the device or that prevents blood coagulation. 
     
     
         58 . A balloon catheter of  claim 45  wherein said drug is paclitaxel and said device is an angioplasty balloon catheter having a smooth balloon surface. 
     
     
         59 . A method for producing a balloon catheter according to  claim 45 , comprising applying the lipophilic drug in a solution medium using an immersion, spreading, or spraying process to the surface of the folded balloon, and removing excess media and substances that adhere loosely to the surface. 
     
     
         60 . The method according to  claim 59 , wherein the application process is carried out repeatedly to achieve a reproducible increase of the drug content using a same solution medium and/or excipient. 
     
     
         61 . The method according to  claim 60 , wherein ethanol is used as the solution medium. 
     
     
         62 . The method according to  claim 59 , wherein a folded and substantially ready for use balloon is used as a drug carrier coated before or after sterilization with or without a crimped-on stent. 
     
     
         63 . The method according to  claim 59 , wherein a stent is connected to the balloon catheter before or after coating. 
     
     
         64 . A method for the treatment of a vascular disease or a dysfunction of circulation comprising administering a catheter of  claim 45 . 
     
     
         65 . A method for opening a passage in the body comprising administering a catheter of  claim 45 . 
     
     
         66 . A method for tumor treatment comprising administering a catheter of  claim 45 . 
     
     
         67 . A balloon catheter medical device that releases a drug by immediate release for the selective therapy of specific diseased tissue or an organ part to which said drug will bind, comprising such a drug which is lipophilic, water-insoluble and immediately releasable, adhered to a surface of the balloon of said catheter that comes into contact with the diseased tissue or organ part, which adhered drug when pressed against said tissue or organ part at least for a short time, is immediately released into said tissue or organ part, wherein the drug is adhered to said surface in a manner resulting in an amount of drug retained on said device of about 10% or less after a time period in which said balloon surface is in contact with said tissue of up to a few minutes, and wherein the concentration of said drug on said surface is up to 20 μg/mm 2 . 
     
     
         68 . A balloon catheter of  claim 67  wherein said drug is paclitaxel and said device is an angioplasty balloon catheter having a smooth balloon surface. 
     
     
         69 . The device of  claim 22  wherein the lipophilic drug is present as a dry solid on the surface of the device. 
     
     
         70 . The device of  claim 69  wherein the lipophilic drug is paclitaxel. 
     
     
         71 . The device of  claim 69  wherein the dried solid also comprises a contrast agent. 
     
     
         72 . The catheter of  claim 45  wherein the lipophilic drug is present as a dry solid on the surface of the device. 
     
     
         73 . The catheter of  claim 72  wherein the lipophilic drug is paclitaxel. 
     
     
         74 . The catheter of  claim 72  wherein the dried solid also comprises a contrast agent. 
     
     
         75 . The device according to  claim 22 , wherein the concentration of said drug on said surface is up to 5 μg/mm 2 . 
     
     
         76 . The device according to  claim 22 , wherein the concentration of said drug on said surface is between 0.2 and 20 μg/mm 2 . 
     
     
         77 . The device according to  claim 45 , wherein the concentration of said drug on said surface is up to 5 μg/mm 2 . 
     
     
         78 . The device according to  claim 45 , wherein the concentration of said drug on said surface is between 0.2 and 20 μg/mm 2 . 
     
     
         79 . The device according to  claim 67 , wherein the concentration of said drug on said surface is up to 5 μg/mm 2 . 
     
     
         80 . The device according to  claim 67 , wherein the concentration of said drug on said surface is between 0.2 and 20 μg/mm 2 .