Coated implantable medical device

• US 7,896,914 B2
• Filed: 10/31/2007
• Issued: 03/01/2011
• Est. Priority Date: 06/07/1995
• Status: Expired due to Fees

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated), MED Institute, Inc. (Cook Group Incorporated)
• Inventors: Kozma, Thomas G., Bates, Brian L., Fearnot, Neal E., Ragheb, Anthony O., Voorhees, William D. III
• Primary Examiner(s): PREBILIC, PAUL B
• Application Number:
  US11/931,694
• Publication Number:
  US 20080215138A1
• Time in Patent Office: 1,217 Days
• Field of Search: 623 142- 146, 604264-265, 604/891.1, 604/892.1
• US Class Current: 623/1.42
• 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 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 2300/416 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 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: 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. A therapeutic agent-releasing implantable medical stent device, comprising:

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

a two-layer coating system on the metal stent structure, the coating system extending from the metal surface to an outermost surface of the medical stent device, and the two-layer coating system consisting of a first layer and a second layer;

wherein the first layer is a coating layer consisting of polymer material deposited directly on the metal surface; and

wherein the second layer comprises an immunosuppressive agent at a level of about 0.1 milligrams per square centimeter of the gross surface area of the metal stent structure, wherein the second layer is deposited on the coating layer so as to provide the outermost surface of the medical stent device, and wherein the second layer is effective to release the immunosuppressive agent at a site of implantation of the stent device.

2. The device of claim 1, wherein the immunosuppressive agent is cyclosporin.

3. The device of claim 1, wherein the coating layer has a thickness in a range from 50,000 to 500,000 Angstroms.

4. The device of claim 1, wherein the second layer further comprises a polymer.

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

6. The device of claim 1, wherein the metal stent structure comprises at least one of stainless steel, tantalum, titanium, nitinol, gold, platinum, inconel, iridium, silver, or tungsten.

9. The device of claim 1, wherein the coating layer comprises an n-butyl-acrylate polymer, an n-butyl-methacrylate polymer, a 2-ethylhexylacrylate polymer, a lauryl-acrylate polymer, or a 2-hydroxy-propylacrylate polymer.

10. The device of claim 9, wherein the coating layer comprises an n-butyl-acrylate polymer or an n-butyl-methacrylate polymer.

11. The device of claim 10, wherein the coating layer comprises an n-butyl-acrylate polymer.

12. The device of claim 10, wherein the coating layer comprises an n-butyl-methacrylate polymer.

13. The device of claim 1, wherein the second layer further comprises a biostable polymer.

14. The device of claim 1, wherein the second layer further comprises a polyvinylidene halide.

15. The device of claim 1, wherein the second layer further comprises a vinyl halide copolymer.

7. A therapeutic agent-releasing medical stent device comprising:

a metal vascular stent adapted for introduction into a patient, the stent having at least one metal surface;

a coating layer comprising a first biostable polymer deposited directly on the metal surface in the absence of any therapeutic agent;

a layer comprising a second polymer and a therapeutic agent deposited directly on the coating layer, wherein the therapeutic agent is an immunosuppressive agent present at a level of about 0.1 milligrams per square centimeter of the gross surface area of the metal vascular stent; and

wherein said layer comprising a second polymer and a therapeutic agent (i) is the outermost layer of the medical device, and (ii) is effective to release the immunosuppressive agent at a site of implantation of the stent device.

16. The device of claim 7, wherein the first biostable polymer is an n-butyl-acrylate polymer, an n-butyl-methacrylate polymer, a 2-ethylhexylacrylate polymer, a lauryl-acrylate polymer, or a 2-hydroxy-propylacrylate polymer.

17. The device of claim 16, wherein the first biostable polymer is an n-butyl-acrylate polymer or an n-butyl methacrylate polymer.

18. The device of claim 17, wherein the first. biostable polymer is an n-butyl-acrylate polymer.

19. The device of claim 17, wherein the first biostable polymer is an n-butyl-methacrylate polymer.

20. The device of claim 7, wherein the second biostable polymer is a polyvinylidene halide polymer.

21. The device of claim 20, wherein the second biostable polymer is a polyvinylidene fluoride polymer.

22. The device of claim 7 wherein the second biostable polymer is a vinyl halide copolymer.

23. The device of claim 7, wherein the first biostable polymer is parylene or a parylene derivative.

8. A therapeutic agent-releasing medical stent device comprising:

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

a coating system consisting of first and second polymer layers on the metal surface;

wherein the first polymer layer is a biostable polymer coating layer on the metal surface, the biostable polymer coating layer provided by applying a first biostable polymer free from any bioactive agent to the metal surface, wherein the first biostable polymer is an n-butyl-acrylate polymer, an n-butyl-methacrylate polymer, a 2-ethylhexylacrylate polymer, a lauryl-acrylate polymer, or a 2-hydroxy-propylacrylate polymer;

wherein the second polymer layer is a polymer layer deposited on the first polymer layer, with the second polymer layer comprising a second polymer and an immunosuppressive agent present at a level of about 0.1 milligrams per square centimeter of the gross surface area of the metal stent, wherein the second polymer layer provides the outermost layer of the medical stent device, and wherein the second polymer layer is effective to release the immunosuppressive agent at a site of implantation of the medical stent device.

24. The device of claim 8, wherein the first biostable polymer is an n-butyl-acrylate polymer or an n-butyl-methacrylate polymer.

25. The device of claim 24, wherein the first biostable polymer is an n-butyl-acrylate polymer.

26. The device of claim 24, wherein the first biostable polymer is an n-butyl-methacrylate polymer.

27. The device of claim 8, wherein, the second biostable polymer is a polyvinylidene halide polymer.

28. The device of claim 27, wherein the second biostable polymer is a polyvinylidene fluoride polymer.

29. The device of claim 8, wherein the second biostable polymer is a vinyl halide copolymer.