Method of delivering an implantable medical device with a bioabsorbable coating

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 cm 2 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 μg 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 cm 2 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.