Coated implantable medical device

• US 6,730,064 B2
• Filed: 05/07/2001
• Issued: 05/04/2004
• Est. Priority Date: 08/20/1998
• Status: Expired due to Term

• Current Assignee: Cook Medical Incorporated (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. III
• Primary Examiner(s): Casler, Brian L.
• Assistant Examiner(s): Sirmons, Kevin C.
• Application Number:
  US09/850,691
• Publication Number:
  US 20020032414A1
• Time in Patent Office: 1,093 Days
• Field of Search: 623/1.46, 623/1.45, 623/1.44, 623/1.43, 623/1.42, 623/1.11, 604/20, 604/96.1, 604/265, 604/266, 604/890.1, 604/892.1, 424/423, 424/1.65, 424/9.36, 424/1.69, 514/449, 514/250, 427/2.25, 427/2.21
• US Class Current: 604/265
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• 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 2300/608 having two or more layers
• CPC Class Codes: A61L 2420/08 Coatings comprising two or more layers
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• 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: C08L 65/04 Polyxylenes
• CPC Class Codes: H01L 2924/00 Indexing scheme for arrangements or methods for connecting or disconnecting semiconductor or solid-state bodies as covered by H01L24/00
• CPC Class Codes: H01L 2924/3025 Electromagnetic shielding

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 is 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 (10), comprising:

a structure (12) adapted for introduction into a patient, the structure (12) having at least one surface and being composed of a base material (14);

at least one coating layer (16) posited on one surface of the structure (12); and

at least one layer (18) of a first bioactive material posited over at least a portion of the at least one coating layer (16), wherein said at least one coating layer (16) provides for a controlled release of the bioactive material from the at least one coating layer (16), and wherein said first bioactive material (18) comprises paclitaxel and inhibits restenosis.

2. The device (10) of claim 1 wherein said coating layer has a surface energy density to increase adhesion of said first bioactive material to said coating layer.

3. The device (10) of claim 1 further comprising at least one porous layer (20) posited over the bioactive material layer (18), wherein said at least one porous layer (20) is composed of a polymer and said polymer provides for a controlled release of the bioactive material through said at least one porous layer.

4. The device (10) of claim 1, wherein the coating layer (16) comprises a non-porous material.

5. The device (10) of claim 4, wherein the non-porous material is at least one of an adsorbent material and an absorbent material.

6. The device (10) of claim 5, wherein the at least one coating layer (16) of the adsorbent material has a thickness of approximately 230,000 Angstroms.

7. The device (10) of claim 1, wherein the at least one coating layer (16) comprises a parylene derivative.

8. The device (10) of claim 7, wherein the at least one coating layer (16) has a thickness in a range from 50,000 to 500,000 Angstroms.

9. The device (10) of claim 7, wherein the at least one coating layer (16) has a thickness in a range from 100,000 to 500,000 Angstroms.

10. The device (10) of claim 7, wherein the at least one coating layer (16) has a thickness of approximately 200,000 Angstroms.

11. The device (10) of claim 1, wherein the bioactive material layer includes a chimeric monoclonal antibody.

12. The device (10) of claim 1, wherein the polymer is selected from the group consisting of a polyamide, polymers of parylene or derivatives thereof, poly(ethylene oxide), poly(ethylene glycol), poly(propylene oxide), silicone based polymers, polymers of methane, tetrafluoroethylene or tetramethyldisiloxane or a polymer derived from photopolymerizeable monomers.

13. The device of claim 1, wherein said paclitaxel is in a concentration of between 0.06 μ

g/mm² and 60 μ

g/mm².

14. The device of claim 1, wherein said paclitaxel is in a concentration of between 1.5 μ

g/mm² and 5 μ

g/mm².

15. The device of claim 1, wherein said paclitaxel is in a concentration of about 1.8 μ

g/mm².

16. The device of claim 1, wherein said paclitaxel is in an amount of at least 35 μ

g.

17. The device of claim 1, wherein said paclitaxel is in an amount of at least 35 μ

g and includes at least up to a total of 400 μ

g of a mixture of paclitaxel and parylene N.

18. An implantable medical device (10), comprising:

a structure (12) adapted for introduction into a patient, the structure (12) having at least one surface and being comprised of a base material (14); and

at least one layer (18) of a bioactive material posited on the at least one surface of the structure (12), wherein said at least one surface has been treated and has a surface energy density to increase adhesion of said bioactive material to said base material, and wherein said bioactive material (18) comprises paclitaxel and inhibits restenosis.

19. The device (10) of claim 18 further comprising at least one porous layer (20) posited over the bioactive material layer (18), wherein said at least one porous layer (20) includes a polymer and said polymer provides for a controlled release of the bioactive material therethrough.

20. The device (10) of claim 19 further comprising at least one coating layer (16) disposed between the structure (12) and the at least one bioactive material layer (18).

21. The device of claim 18, wherein said paclitaxel is in a concentration of between 0.06 μ

g/mm² and 60 μ

g/mm².

22. The device of claim 18, wherein said paclitaxel is in a concentration of between 1.5 μ

g/mm² and 5 μ

g/mm².

23. The device of claim 18, wherein said paclitaxel is in a concentration of about 1.8 μ

g/mm².

24. The device of claim 18, wherein said paclitaxel is in an amount of at least 35 μ

g.

25. The device of claim 18, wherein said paclitaxel is in an amount of at least 35 μ

g and includes at least up to a total of 400 μ

g of a mixture of paclitaxel and parylene N.