Method of treating a patient with a coated implantable medical device

• US 7,445,628 B2
• Filed: 04/14/2003
• Issued: 11/04/2008
• Est. Priority Date: 06/07/1995
• 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, Osborne, Thomas A.
• Primary Examiner(s): Prebilic; Paul B.
• Application Number:
  US10/414,444
• Publication Number:
  US 20040047909A1
• Time in Patent Office: 2,031 Days
• Field of Search: 623 142- 146, 604/264, 604/265, 604/891.1, 604/892.1, 424/471, 514/449
• 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 2300/256 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

Methods of making coated implantable medical devices are provided. The methods include positioning a first layer comprising a bioactive on at least a portion of a structure, and positioning at least one porous layer over the first layer. The at least one porous layer has a thickness adequate to provide a controlled release of the bioactive.

Claims

1. A method of treating a human or veterinary patient, comprising implanting a vascular stent at a point of treatment within the vascular system of a human or veterinary patient, the vascular stent comprising a surface, a coating layer consisting of a parylene polymer posited on the surface of the vascular stent, a layer comprising an immunosuppressive agent posited on at least a portion of the coating layer, and a porous layer comprising a second polymer overlaying the layer comprising the immunosuppressive agent.

2. The method of claim 1, wherein the surface of the vascular stent comprises stainless steel.

3. The method of claim 1, wherein about 0.01 mg to about 10 mg of the immunosuppressive agent is present per cm² of the gross surface area of the vascular stent.

4. The method of claim 1, wherein about 0.1 mg to about 4 mg of the immunosuppressive agent is present per cm² of the gross surface area of the vascular stent.

9. The method of claim 1, wherein the thickness of the porous layer provides for a controlled release of the immunosuppressive agent through the porous layer.

13. The method of claim 1, wherein the coating layer has a thickness of about 50,000 to 500,000 Angstroms.

14. The method of claim 1, wherein the porous layer has a thickness of about 5,000 to 250,000 Angstroms.

16. The method of claim 1, wherein the coating layer has a thickness of about 50,000 to 500,000 Angstroms;

the layer comprising the immunosuppressive agent contains a total of about 0.1 mg to 4 mg of immunosuppressive agent per cm² of the gross surface area of the vascular stent and the porous layer has a thickness of about 5,000 to 250,000 Angstroms; and

the vascular stent is about 10 mm to about 60 mm in length and is designed to expand to a diameter of about 2 mm to about 6 mm.

5. A method of inhibiting restenosis in a blood vessel, comprising deploying a vascular stent in a blood vessel, the vascular stent comprising a surface, a coating layer consisting of a parylene or a parylene derivative polymer posited on the surface of the vascular stent, a layer comprising an immunosuppressive agent posited on at least a portion of the coating layer, and a porous layer comprising a second polymer overlaying the layer comprising the immunosuppressive agent and having a thickness adequate to provide a controlled release of the immunosuppressive agent.

6. The method of claim 5, wherein the coating layer consists of the parylene derivative polymer.

7. The method of claim 5, wherein about 0.01 mg to about 10 mg of the immunosuppressive agent is present per cm² of the gross surface area of the vascular stent.

8. The method of claim 5, wherein about 0.1 mg to about 4 mg of the immunosuppressive agent is present per cm² of the gross surface area of the vascular stent.

10. A method of treating a human or veterinary patient, comprising implanting a vascular stent at a point of treatment within the vascular system of a human or veterinary patient, the vascular stent comprising a surface, a coating layer consisting of parylene or a parylene derivative polymer posited on the surface of the vascular stent, a layer comprising a second polymer attached to an immunosuppressive agent, and a porous layer comprising a third polymer overlaying the layer comprising the immunosuppressive agent and having a thickness adequate to provide a controlled release of the immunosuppressive agent.

11. The method of claim 10, wherein the coating layer consists of the parylene derivative polymer.

12. The method of claim 10, wherein the porous layer consists of the third polymer.

15. The method of claim 10, wherein 0.1 mg to 4 mg of the immunosuppressive agent is present per cm² of gross surface area of the vascular stent.