Method of delivering an implantable medical device with a bioabsorbable coating

• US 8,313,521 B2
• Filed: 11/15/2006
• Issued: 11/20/2012
• Est. Priority Date: 06/07/1995
• Status: Expired due to Term

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Ruane, Patrick H., Perez-Segarra, Waleska, Ragheb, Anthony O., Fearnot, Neal E., Voorhees, William D. III, Bates, Brian L., Osborne, Thomas A.
• Primary Examiner(s): PREBILIC, PAUL B
• Application Number:
  US11/599,859
• Publication Number:
  US 20070150047A1
• Time in Patent Office: 2,197 Days
• Field of Search: 623/1.11, 623 142- 143
• US Class Current: 623/1.11
• 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 2300/602 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 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 31/146 Porous materials, e.g. foams or sponges
• 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

Abstract

Methods of delivering a bioactive material to a body vessel are disclosed. The method steps can include providing an expandable medical device with a coating having a bioactive layer, and providing a second layer of a biodegradable polymer positioned over the bioactive layer. The second layer provides for controlled release of the bioactive material from the bioactive layer. The medical device is inserted into a body vessel using a catheter such that the medical device contacts the body vessel.

Claims

1. A method of delivering a bioactive material to a body vessel comprising the steps of:

providing an expandable medical device sized and shaped for introduction into a vascular system of a patient, the expandable medical device having a vessel surface and a lumen surface and a coating on the vessel surface, the coating comprising a bioactive layer consisting essentially of paclitaxel or a derivative thereof, the bioactive layer being positioned between the vessel surface of the expandable medical device and a second layer, the second layer consisting essentially of a biodegradable polymer, wherein the second layer is free of a biostable polymer, wherein the second layer provides for controlled release of the paclitaxel or a derivative thereof and is free of bioactive material when deposited, the second coating layer positioned over the bioactive layer;

inserting the expandable medical device into a body vessel using a catheter; and

deploying the expandable medical device within the body vessel by placing the expandable medical device in contact with at least a portion of the body vessel, whereby the paclitaxel or derivative thereof is delivered to the body vessel.

2. The method of claim 1, wherein the expandable medical device is deployed in a peripheral arterial body vessel.

3. The method of claim 1, wherein the expandable medical device is deployed in a body vessel selected from the group consisting of:

a renal artery and an iliac artery.

4. The method of claim 1, wherein the biodegradable polymer is selected from the group consisting of:

polylactic acid, polyglycolic acid or copolymers thereof, a polyanhydride, polycaprolactone, and polyhydroxybutyrate valerate.

5. The method of claim 1, wherein the biodegradable polymer is polylactic acid.

6. The method of claim 1, wherein the coating has two layers and consists of the bioactive layer and the second layer.

7. The method of claim 1, wherein the bioactive layer contains about 0.01 to 10.0 mg of the paclitaxel or paclitaxel derivative per cm² of the area of the vessel surface of the vascular stent.

8. The method of claim 1, wherein the medical device is a stent and the vessel surface is a metallic surface and wherein the coating further comprises a coating layer comprising parylene or a parylene derivative positioned directly in contact with the vessel surface and between the vessel surface of the stent and the bioactive layer.

9. The method of claim 8, wherein the coating layer consists of parylene.

10. The method of claim 9, wherein the coating layer has a thickness of about 5,000 to 50,000 Angstroms.

11. The method of claim 1, wherein the medical device is a vascular stent having a length of about 10 to about 60 mm and is designed to expand to a diameter of about 2 to about 6 mm.

12. The method of claim 1, wherein the bioactive layer contains about 100 to 300 μ

g of the paclitaxel or paclitaxel derivative per 0.001-inch of coating thickness.

13. The method of claim 1, wherein

a. the medical device is a vascular stent having a length of about 10 to about 60 mm and is designed to expand to a diameter of about 2 to about 6 mm;

b. the coating is a two-layer coating consisting essentially of;

i. the bioactive layer consisting of 0.01 to 10.0 mg of the paclitaxel or a paclitaxel derivative per cm² of the area of a vessel surface of the vascular stent, and

ii. the second layer consisting essentially of a biodegradable polymer selected from the group consisting of;

polylactic acid, polyglycolic acid, a polyanhydride, polycaprolactone, and polyhydroxybutyrate valerate; and

the second layer having a thickness of about 5,000 to about 250,000 Angstroms

wherein the expandable stent is deployed within a peripheral arterial body vessel by expanding the vascular stent to a diameter of about 2 to about 6 mm to place the vessel surface of the stent in contact with at least a portion of the body vessel.

14. A method of delivering a bioactive material to a body vessel comprising the steps of:

providing an expandable medical device sized and shaped for introduction into a vascular system of a patient, the expandable medical device having a vessel surface and a lumen surface and a coating on the vessel surface, the coating comprising a bioactive layer consisting essentially of the bioactive material, the bioactive layer being positioned between the vessel surface of the expandable medical device and a second layer, the second layer consisting essentially of a biodegradable polymer, wherein the second layer is free of a biostable polymer, wherein the second layer provides for controlled release of the bioactive material and is free of the bioactive material when deposited;

inserting the expandable medical device into a body vessel using a catheter; and

deploying the expandable medical device within the body vessel by placing the expandable medical device in contact with at least a portion of the body vessel, whereby the bioactive material is delivered to the body vessel.

15. A method of delivering a bioactive material to a body vessel comprising the steps of:

providing an expandable vascular stent sized and shaped for introduction into a vascular system of a patient, the expandable medical device having a vessel surface and a lumen surface and a coating on the vessel surface, the coating comprising a bioactive layer consisting essentially of the bioactive material, the bioactive layer being positioned between the vessel surface of the expandable medical device and a second layer, the second layer consisting essentially of a biodegradable polymer, wherein the second layer is free of a biostable polymer, wherein the second layer provides for controlled release of the bioactive material and is free of the bioactive material when deposited;

inserting the expandable medical device into a body vessel using a catheter; and

deploying the expandable medical device within the body vessel by placing the expandable medical device in contact with at least a portion of the body vessel, whereby the bioactive material is delivered to the body vessel.