Coated implantable medical device

Abstract

A coated implantable medical device includes a structure adapted for introduction into the vascular system, esophagus, trachea, colon, biliary tract, or urinary tract; at least one coating layer posited on one surface of the structure; and at least one layer of a bioactive material posited on at least a portion of the coating layer. Preferably, the structure is a stent graft.

1 . A medical device adapted for placement in a body vessel, the medical device comprising: a sleeve having a lumen surface and an outer surface; and an anti-hypertensive bioactive agent adsorbed on or absorbed into the sleeve, the sleeve comprising a base material forming at least a portion of the outer surface. 
   
   
       2 . The medical device of  claim 1 , wherein the anti-hypertensive bioactive agent comprises an angiotensin converting enzyme (ACE) inhibitor. 
   
   
       3 . The medical device of  claim 1 , wherein the anti-hypertensive bioactive agent is selected from the group consisting of: captopril and enalapril. 
   
   
       4 . The medical device of  claim 1 , wherein the anti-hypertensive bioactive agent is absorbed onto the sleeve to form a coating layer configured for a controlled release of the anti-hypertensive bioactive agent. 
   
   
       5 . The medical device of  claim 4 , wherein the coating layer has a thickness of at least about 50 Angstroms posited on the surface of the structure. 
   
   
       6 . The medical device of  claim 4 , wherein the coating layer further comprises a material selected from the group consisting of: silane, polyimide, poly(ethylene oxide), poly(ethylene glycol), poly(propylene oxide), silicone, tetrafluoroethylene, tetramethyldisiloxane, parylene and a polymer of methane and parylene. 
   
   
       7 . The medical device of  claim 1 , wherein the medical device is configured as a vascular graft. 
   
   
       8 . The medical device of  claim 1 , further comprising an expandable stent attached to the sleeve. 
   
   
       9 . The medical device of  claim 8 , wherein the base material comprises tetrafluoroethylene. 
   
   
       10 . The medical device of  claim 8 , wherein the frame is radially self-expanding or balloon expandable within a body vessel. 
   
   
       11 . The medical device of  claim 4 , wherein the coating layer is posited on the base material, and
 wherein the medical device is configured as a vascular graft; and   wherein the coating layer comprises a material selected from the group consisting of: polyimide, silane, poly(ethylene oxide), poly(ethylene glycol), poly(propylene oxide), silicone, tetrafluoroethylene, tetramethyldisiloxane, a polymer of methane and parylene; and   wherein the base material comprises a material selected from the group consisting of: silicone, polyethyleneterephthalate, polyurethane, polyamide, polyester, polyorthoester, polyanhydride, polyether sulfone, polycarbonate, polypropylene, high molecular weight polyethylene, polytetrafluoroethylene, polylactic acid, polyglycolic acid, a polyanhydride, polycaprolactone, polyhydroxy-butyrate valerate or another biodegradable polymer, a protein, an extracellular matrix component, collagen, and fibrin; and   wherein the bioactive further comprises one or more materials selected from the group consisting of: heparin, hirudin, hirulog, argatroban, D-phenylalanyl-L-poly-L-arginyl chloromethyl ketone, urokinase, streptokinase, aspirin, ticlopidine, colchicine, cytochalasin, methotrexate, dexamethasone, cyclosporin, trapidal, angiopeptin, dopamine, bromocriptine mesylate, pergolide mesylate, silver, captopril, enalapril, ascorbic acid, alphatocopherol, superoxide dismutase, deferoxyamine, a 21-aminosteroid (lasaroid), a thrombin inhibitor, an antithrombogenic agent, a tissue plasminogen activator, a thrombolytic agent, a fibrinolytic agent, a vasospasm inhibitor, a calcium channel blocker, a nitrate, a nitric oxide promoter, a vasodilator, an antimicrobial agent, an antibiotic agent, a glycoprotein IIb/IIIa inhibitor, an inhibitor of surface glycoprotein receptors, an antiplatelet agent, an antimitotic agent, a microtubule inhibitor agent, a retinoid, an antisecretory agent, an actin inhibitor, a remodeling inhibitor, a deoxyribonucleic acid, an antisense nucleotide, an antiproliferative agent, an anti-cancer chemotherapeutic agent, an anti-inflammatory steroid, a non-steroidal anti-inflammatory agent, an immunosuppressive agent, a PDGF antagonist agent, a growth hormone antagonist agent, an anti-growth factor antibody, a growth factor, a growth factor antagonist, a dopamine agonist agent, a radiotherapeutic agent, a radiopaque agent, a peptide, a protein, an enzyme, an extracellular matrix component, a second angiotensin converting enzyme (ACE) inhibitor, a free radical scavenger agent, an iron chelator agent, an antioxidant agent, and a radiolabelled agent.   
   
   
       12 . An implantable medical device comprising:
 a sleeve material formed from a base material and having at least one surface;   a coating layer having a thickness of at least about 50 Angstroms posited on the surface of the structure; and   a bioactive material adsorbed into or absorbed into the coating layer.   
   
   
       13 . The implantable medical device of  claim 12 , wherein the base material comprises a material selected from the group consisting of: polytetrafluoroethylene, pyrolyzed carbon, carbon fiber, silicone, silane, fibrin, polyethyleneterephthalate, a polyimide, polyurethane, a polyamide, a polyester, a polyorthoester, a polyanhydride, polyether sulfone, a polycarbonate, polypropylene, fibrinogen, starch, collagen, hyaluronic acid, polyolefins, polyisobutylene, an ethylene-alphaolefin copolymer, acrylic polymers, vinyl halide polymers, polyvinyl chloride, polyvinyl ethers, polyvinyl methyl ether, olyvinylidene halides, polyvinylidene fluoride, polyvinylidene chloride, polyacrylonitrile, polyvinyl ketones, polyvinyl aromatics, polystyrene, polyvinyl esters, polyvinyl acetate, cethylene-methyl methacrylate copolymers, acrylonitrile-styrene copolymers, ABS resin, ethylene-vinyl acetate copolymers, polyamides, Nylon 66, polycaprolactam, alkyd resins, polycarbonates, polyoxymethylenes, polyimides, polyethers, epoxy resins, rayon, and cellulose. 
   
   
       14 . The medical device of  claim 12 , wherein the medical device is configured as a vascular graft. 
   
   
       15 . A method for providing a bioactive material into a body lumen comprising the steps of:
 (a) providing a medical device cylindrical flexible sleeve;   (b) applying to the cylindrical flexible sleeve a solution which includes a first volatile solvent, a first polymer dissolved in the solvent and a bioactive material dispersed in the first solvent;   (c) evaporating the volatile solvent to form a coating layer comprising the bioactive material and the polymer on the cylindrical flexible sleeve; and   (d) applying a porous layer comprising a second polymer on at least a portion of the coating layer by the steps of:
 (1) applying a solution which includes a second volatile solvent and the second polymer dissolved in the second solvent to the cylindrical sleeve; 
 (2) evaporating the second solvent; and 
 (3) repeating application and evaporating steps (1) and (2) to provide a coating layer of a thickness to provide for the controlled release of the bioactive material through the porous layer. 
   
   
   
       16 . The method of  claim 15 , wherein the first solvent and the second solvent comprise ethanol. 
   
   
       17 . The method of  claim 15 , wherein the first polymer and the second polymer are the same and are selected from the group consisting of: polytetrafluoroethylene, pyrolyzed carbon, carbon fiber, silicone, silane, fibrin, polyethyleneterephthalate, a polyimide, polyurethane, a polyamide, a polyester, a polyorthoester, a polyanhydride, polyether sulfone, a polycarbonate, polypropylene, fibrinogen, starch, collagen, hyaluronic acid, polyolefins, polyisobutylene, an ethylene-alphaolefin copolymer, acrylic polymers, vinyl halide polymers, polyvinyl chloride, polyvinyl ethers, polyvinyl methyl ether, olyvinylidene halides, polyvinylidene fluoride, polyvinylidene chloride, polyacrylonitrile, polyvinyl ketones, polyvinyl aromatics, polystyrene, polyvinyl esters, polyvinyl acetate, cethylene-methyl methacrylate copolymers, acrylonitrile-styrene copolymers, ABS resin, ethylene-vinyl acetate copolymers, polyamides, Nylon 66, polycaprolactam, alkyd resins, polycarbonates, polyoxymethylenes, polyimides, polyethers, epoxy resins, rayon, and cellulose. 
   
   
       18 . The method of  claim 15 , further comprising the steps of:
 (e) introducing the medical device within a body vessel using a catheter; and   (f) radially expanding the cylindrical sleeve within the body vessel.   
   
   
       19 . The method of  claim 15 , wherein the medical device is a stent graft further comprising an expandable stent attached to the sleeve. 
   
   
       20 . The medical device of  claim 19 , wherein the frame is radially self-expanding or balloon expandable within a body vessel.