Coated implantable medical device

• US 20050222677A1
• Filed: 05/25/2005
• Published: 10/06/2005
• Est. Priority Date: 06/07/1995
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Fearnot, Neil E., Bates, Brian L., Kozma, Thomas G., Ragheb, Anthony O., Voorhees, William D. III
• Granted Patent: US 8,556,962 B2
• Time in Patent Office: Days
• US Class Current: 623/1.420
• 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 10 includes a structure 12 adapted for introduction into the vascular system, esophagus, trachea, colon, biliary tract, or urinary tract; at least one coating layer 16 posited on one surface of the structure; and at least one layer 18 of a bioactive material posited on at least a portion of the coating layer 16, wherein the coating layer 16 provides for the controlled release of the bioactive material from the coating layer. In addition, at least one porous layer 20 can be posited over the bioactive material layer 18, wherein the porous layer includes a polymer and provides for the controlled release of the bioactive material therethrough. Preferably, the structure 12 is a coronary stent. The porous layer 20 includes a polymer applied preferably by vapor or plasma deposition and provides for a controlled release of the bioactive material. It is particularly preferred that the polymer is a polyamide, parylene or a parylene derivative, which is deposited without solvents, heat or catalysts, and merely by condensation of a monomer vapor.

Claims

1. An implantable medical device, comprising:

a structure adapted for introduction into a patient, the structure having at least one surface;

a bioactive posited over the at least one surface of the structure; and

at least one porous layer posited over the bioactive.

2. The device of claim 1, wherein the bioactive is selected from the group consisting of:

an immunosuppressive agent, an antiproliferative agent and an antisense nucleotide.

3. The device of claim 1, wherein the bioactive is selected from the group consisting of:

angiopeptin, dexamethasone, estrogen, cyclosporin, and paclitaxel.

4. The device of claim 1, wherein the at least one porous layer comprises a biostable polymer.

5. The device of claim 1, wherein the at least one porous layer comprises a polymer selected from the group consisting of:

polystyrene, isobutylene, a polyalkylmethacrylate, polyethylene, vinyl acetate, cyanoacrylate, polytetrafluoroethylene, and copolymers thereof.

6. The device of claim 1, wherein the at least one porous layer comprises a bioabsorbable polymer.

7. The device of claim 1, wherein the at least one porous layer comprises a polymer selected from the group consisting of:

polylactic acid, polyglycolic acid, polycaprolactone, polyethyleneglycol, polyhydroxybutyrate, a polyorthoester and copolymers thereof.

8. The device of claim 1, further comprising at least one coating layer posited over the at least one surface of the structure;

wherein the bioactive is adsorbed on or absorbed into the at least one coating layer.

9. The device of claim 8, wherein the at least one coating layer has a thickness in a range from 50,000 to 500,000 Angstroms.

10. The device of claim 1, wherein the structure is configured as a vascular stent.

11. The device of claim 1, wherein the structure comprises a base material selected from the group consisting of:

stainless steel, tantalum, titanium, nitinol, gold, platinum, inconel, iridium, silver, tungsten, a biocompatible metal, and any alloy thereof.

12. The device of claim 1, wherein the structure comprises a base material selected from the group consisting of:

carbon, carbon fiber, cellulose acetate, cellulose nitrate, silicone, polyethylene teraphthalate, polyurethane, polyamide, polyester, polyorthoester, polyanhydride, polyether sulfone, polycarbonate, polypropylene, high molecular weight polyethylene, polytetrafluoroethylene, a biocompatible polymeric material, polylactic acid, polyglycolic acid, a polyanhydride, polycaprolactone, polyhydroxybutyrate valerate, a protein, an extracellular matrix component, collagen, fibrin, any biologic agent, and a copolymer or mixture thereof.

13. The device of claim 1, wherein the structure is composed of a base material having at least one aperture in which at least a portion of the bioactive is contained.

14. The device of claim 1, further comprising at least one well formed in the at least one surface of the structure, wherein at least a portion of the bioactive is contained in the at least one well.

15. The device of claim 14, wherein the at least one well is a groove or slot and wherein the bioactive is an immunosuppressive agent.

16. A medical device comprising:

a vascular stent adapted for introduction into a patient, the vascular stent comprising a base material and having at least one surface;

a bioactive posited over the at least one surface of the vascular stent; and

at least one porous layer posited over the bioactive.

17. The implantable medical device of claim 16, wherein the base material comprises stainless steel, the porous layer comprises a copolymer of polystyrene and isobutylene, and the bioactive is paclitaxel.

18. The implantable medical device of claim 16, wherein the base material comprises a biocompatible metal;

the porous layer comprises polylactic acid; and

the bioactive is selected from the group consisting of;

an immunosuppressant and an antiproliferative.

19. The implantable medical device of claim 16, wherein the base material comprises stainless steel;

the medical device further comprising an adhesion promoting layer contacting the surface of the base material, the adhesion promoting layer comprising parylene C;

the porous layer comprising poly-N-butylmethacrylate.

20. The implantable medical device of claim 16, wherein the base material comprises a biocompatible metal;

the porous layer comprises phosphatidylcholine; and

the bioactive is selected from the group consisting of;

angiopeptin, dexamethasone, estrogen, cyclosporin, and paclitaxel.

21. The implantable medical device of claim 16, wherein the porous layer comprises a polyalkylcyanoacrylate and the bioactive comprises an antisense nucleotide.

22. The device of claim 16, further comprising a coating layer posited over the at least one surface of the stent;

wherein the bioactive is an immunosuppressive agent posited over at least a portion of the coating layer, wherein the immunosuppressive agent is adsorbed on or absorbed into the at least one coating layer.

23. The device of claim 16, wherein the vascular stent comprises a base material having at least one hole, wherein at least a portion of the bioactive is contained in the at least one hole.

24. The device of claim 16, further comprising at least one well formed in at least one surface of the stent, wherein at least a portion of the bioactive is contained in the at least one well.

25. The device of claim 24, wherein the at least one well is a groove or slot and wherein the bioactive is an immunosuppressive agent.

26. The device of claim 16, further comprising a coating layer posited over the at least one surface of the stent;

wherein the bioactive is contained within at least a portion of the coating layer.

27. The device of claim 26, wherein the bioactive is an immunosuppressive agent.