Coated implantable medical device

• US 6,774,278 B1
• Filed: 02/20/1998
• Issued: 08/10/2004
• Est. Priority Date: 06/07/1995
• Status: Expired due to Term

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated), University of Leicester
• 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, Gershlick, Anthony H.
• Primary Examiner(s): Prebilic, Paul B.
• Application Number:
  US09/027,054
• Time in Patent Office: 2,363 Days
• Field of Search: 623/11, 623/1, 623/12, 623/1.44, 623/1.45, 623/1.46, 623/1.42, 623/1.43, 604/265, 604/264, 604/891.1, 604/892.1
• US Class Current: 623/1.1
• 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 and being composed of a base material;

at least one coating layer posited on one surface of the structure; and

at least one layer of a first bioactive material posited over at least a portion of the at least one coating layer;

wherein said at least one coating layer provides for a controlled release of the bioactive material from the at least one coating layer and wherein said first bioactive material comprises an antibody.

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

3. The device of claim 1, wherein the at least one coating layer comprises a non-porous material.

4. The device of claim 1 wherein the at least one coating layer comprises a parylene derivative.

5. The device of claim 4 wherein the at least one coating layer has a thickness in a range from 50,000 to 500,000 Angstroms.

6. The device of claim 4 wherein the at least one coating layer has a thickness in a range from 100,000 to 500,000 Angstroms.

7. The device of claim 4, wherein the at least one coating layer has a thickness of approximately 200,000 Angstroms.

8. The device of claim 1, wherein the at least one coating layer comprises an adsorbent material and has a thickness of approximately 230,000 Angstroms.

9. The device of claim 1, wherein said antibody comprises an antiplatelet GP IIb/IIIa antibody.

10. The device of claim 1, wherein said antibody comprises a chimeric monoclonal antibody.

11. The device of claim 2, wherein the at least one porous layer is one polymerized from a catalyst-free monomer vapor.

12. The device of claim 2, wherein the polymer is selected from the group consisting of a polyamide, polymers of parylene, derivatives of parylene, poly(ethylene oxide), poly(ethylene glycol), poly(propylene oxide), silicone based polymers, polymers of methane, tetrafluoroethylene, tetramethyldisiloxane and a polymer derived from photopolymerizeable monomers.

15. The device of claim 1, wherein the base material of the structure includes at least one material selected from the group consisting of stainless steel, tantalum, titanium, nitinol, gold, platinum, inconel, iridium, silver, tungsten, any biocompatible metal, any alloy of the aforementioned metals, carbon, carbon fiber, cellulose acetate, cellulose nitrate, silicone, polyethylene terephthalate, polyurethane, polyamide, polyester, polyorthoester, polyanhydride, polyether sulfone, polycarbonate, polypropylene, high molecular weight polyethylene, polytetrafluoroethylene, any biocompatible polymeric material, polylactic acid, polyglycolic acid, a polyanhydride, polycaprolactone, polyhydroxy-butyrate valerate any biologic agent, and any combination of these materials.

16. The device of claim 1, wherein said antibody comprises a monoclonal antibody.

17. The device of claim 1, wherein said antibody comprises a glycoprotein IIb/IIIa antibody.

13. An implantable medical device, comprising:

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

at least one layer of a bioactive material posited on the at least one surface of the structure,

at least one porous layer posited over the bioactive material layer, wherein said at least one porous layer includes a polymer and said polymer provides for a controlled release of the bioactive material therethrough; and

at least one coating layer of adsorptive material disposed between the structure and the at least one bioactive material layer;

wherein said bioactive material comprises an antibody.

14. The device of claim 13, wherein the polymer is selected from the group consisting of polyamide, polymers of parylene, derivatives of parylene, a polymer derived from photopolymerizeable monomers of bisphenol A diglycidyl ether and acrylic acid and a polymer derived from photopolymerizeable monomers of bisphenol A diglycidyl ether and methacrylic acid, and wherein the at least one coating layer is about 50,000 to 500,000 Å

thick.

18. The device of claim 13, wherein said antibody comprises an monoclonal antibody.

19. The device of claim 13, wherein said antibody comprises a chimeric monoclonal antibody.

20. The device of claim 13, wherein said antibody comprises a glycoprotein IIb/IIIa antibody.

21. The device of claim 13, wherein said antibody comprises an antiplatelet glycoprotein IIb/IIIa antibody.