Compositions and methods for coating medical implants

Abstract

Medical implants are provided which release an anthracycline, fluoropyrimidine, folic acid antagonist, podophylotoxin, camptothecin, hydroxyurea, and/or platinum complex, thereby inhibiting or reducing the incidence of infection associated with the implant.

1 .- 23 . (canceled) 
     
     
         24 . A medical implant which comprises a fluoropyrimidine or a composition that comprises a fluoropyridimine, wherein the fluoropyrimidine is in an amount effective to reduce or inhibit infection associated with the medical implant. 
     
     
         25 . The medical implant according to  claim 24 , wherein said implant is covered or coated in whole or in part with the composition comprising the fluoropyrimidine. 
     
     
         26 . The medical implant according to  claim 24 , wherein the fluoropyrimidine is 5-fluorouracil. 
     
     
         27 . The medical implant according to  claim 24 , wherein the implant comprises 1.0 μg to 250 mg fluoropyrimidine. 
     
     
         28 . The medical implant according to  claim 27 , wherein the implant comprises 10 μg to 25 mg fluoropyrimidine. 
     
     
         29 . The medical implant according to  claim 24 , wherein the implant comprises 0.1 μg to 1 mg fluoropyrimidine per mm 2  of surface area of the portion of the medical implant to which the fluoropyrimidine is applied or incorporated. 
     
     
         30 . The medical implant according to  claim 29 , wherein the implant comprises 1 μg to 50 μg fluoropyrimidine per mm 2  of surface area of the portion of the medical implant to which the fluoropyrimidine is applied or incorporated. 
     
     
         31 . The medical implant according to  claim 24 , wherein the fluoropyrimidine is present in an amount effective to reduce or inhibit bacterial infection associated with the medical implant. 
     
     
         32 . The medical implant according to  claim 31 , wherein the bacterial infection is antibiotic resistant. 
     
     
         33 . The medical implant according to  claim 24 , wherein the fluoropyrimidine is present in an amount effective to reduce or inhibit bacterial colonization of the medical implant. 
     
     
         34 . The medical implant according to  claim 24 , wherein the composition further comprises one or more polymers. 
     
     
         35 . The medical implant according to  claim 34 , wherein said composition comprises a non-biodegradable polymer. 
     
     
         36 . The medical implant according to  claim 35 , wherein the non-biodegradable polymer is selected from polyurethanes, acrylic or methacrylic copolymers, cellulose or cellulose-derived polymers, and blends thereof. 
     
     
         37 . The medical implant according to  claim 36 , wherein the polyurethane is a poly(carbonate urethane), poly(ester urethane) or poly(ether urethane). 
     
     
         38 . The medical implant according to  claim 36 , wherein the cellulose-derived cellulose is selected from nitrocellulose, cellulose acetate butyrate, and cellulose acetate propionate. 
     
     
         39 . The medical implant according to  claim 36 , wherein the implant comprises polyurethane and nitrocellulose. 
     
     
         40 . The medical implant according to  claim 24 , wherein the medical implant is selected from endotracheal tubes, tracheostomy tubes, feeding tubes, central nervous shunts, portosystemic shunts, shunts for ascites, arterial lines, tympanostomy tubes, drainage tubes, biliary tubes, conduits, nasogastric tubes, and percutaneous feeding tubes. 
     
     
         41 . The medical implant of  claim 24 , wherein the medical device is a catheter. 
     
     
         42 . The medical implant of  claim 41 , wherein the catheter is a dialysis catheter. 
     
     
         43 . The medical implant of  claim 42 , wherein the dialysis catheter is a hemodialysis catheter. 
     
     
         44 . The medical implant of  claim 42 , wherein the dialysis catheter is a peritoneal dialysis catheter. 
     
     
         45 . The medical implant of  claim 41 , wherein the catheter is a chronic dwelling gastrointestinal catheter, chronic dwelling genitourinary catheter, or urinary catheter. 
     
     
         46 . The medical implant of  claim 41 , wherein the catheter is composed of polyurethane. 
     
     
         47 . The medical implant of  claim 24 , wherein the medical implant further comprises a second anti-infective agent. 
     
     
         48 . The medical implant of  claim 47 , wherein the second anti-infective agent is an antibiotic. 
     
     
         49 . The medical implant of  claim 47 , wherein the second anti-infective agent is an antifungal agent. 
     
     
         50 . The medical implant of  claim 24 , wherein the medical implant further comprise an antithrombotic agent or an antiplatelet agent. 
     
     
         51 . The medical implant of  claim 50 , wherein the antithrombotic agent or the antiplatelet agent is selected from heparin, dextran sulphate, danaparoid, lepirudin, hirudin, AMP, adenosine, 2-chloroadenosine, aspirin, phenylbutazone, indomethacin, meclofenamate, hydrochloroquine, dipyridamole, iloprost, ticlopidine, clopidogrel, abcixamab, eptifibatide, tirofiban, streptokinase, and/or tissue plasminogen activator. 
     
     
         52 . The medical implant of  claim 46 , wherein the implant is coated with a composition comprising polyurethane, nitrocellulose and 5-fluorouracil in an amount of 0.1 μg to 1 mg per mm 2  of surface area of the portion of the catheter to which 5-fluorouracil is applied or incorporated, wherein the catheter releases 5-fluorouracil in an amount effective to reduce or inhibit infection associated with the catheter. 
     
     
         53 . The medical device of  claim 52 , wherein the coating is on the exterior surface of the catheter or a portion thereof. 
     
     
         54 . A method for making a medical implant, comprising covering, coating, combining, loading, associating, or impregnating a medical implant with a fluoropyrimidine or a composition that comprises a fluoropyrimidine in an amount effective to reduce or inhibit infection associated with the medical implant. 
     
     
         55 . The method according to  claim 54  wherein said medical implant is coated by dipping or by impregnation.