Coated implantable medical device

• US 20080132992A1
• Filed: 06/05/2007
• Published: 06/05/2008
• Est. Priority Date: 06/07/1995
• Status: Abandoned Application

• Current Assignee: Cook Incorporated (Cook Group Incorporated), MED Institute, Inc. (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated), MED Institute, Inc. (Cook Group Incorporated)
• Inventors: Bates, Brian L., Fearnot, Neal E., Kozma, Thomas G., Ragheb, Anthony O., Voorhees, William D.
• Application Number:
  US11/810,289
• Publication Number:
  US 20080132992A1
• Time in Patent Office: Days
• US Class Current: 623/1.13
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2/02 Prostheses implantable into the body closure means for urethra or rectum or for artificial body openings therefor A61F2/0004
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61K 51/1282 Devices used in vivo and carrying the radioactive therapeutic or diagnostic agent, therapeutic or in vivo diagnostic kits, stents
• CPC Class Codes: A61L 2300/256 Antibodies, e.g. immunoglobulins, vaccines
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 2300/608 having two or more layers
• CPC Class Codes: A61L 2420/08 Coatings comprising two or more layers
• CPC Class Codes: A61L 27/306 Other specific inorganic materials not covered by A61L27/303 - A61L27/32
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61L 29/106 Inorganic materials other than carbon
• CPC Class Codes: A61L 29/16 : Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61L 31/088 : Other specific inorganic materials not covered by A61L31/084 or A61L31/086
• CPC Class Codes: A61L 31/10 : Macromolecular materials
• CPC Class Codes: A61L 31/16 : Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61L 33/022 : Metal or alloys
• CPC Class Codes: A61N 5/1002 : Intraluminal radiation therapy
• CPC Class Codes: A61P 37/06 : Immunosuppressants, e.g. drugs for graft rejection
• CPC Class Codes: C08L 65/04 : Polyxylenes

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.

Claims

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.