Medical devices to treat or inhibit restenosis

• US 20050137683A1
• Filed: 11/23/2004
• Published: 06/23/2005
• Est. Priority Date: 12/19/2003
• Status: Abandoned Application

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Singh, Sabeena, Trudel, Julie, Hezi-Yamit, Ayala
• Application Number:
  US10/997,662
• Publication Number:
  US 20050137683A1
• Time in Patent Office: Days
• US Class Current: 623/1.420
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• 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

Abstract

Implantable medical devices having anti-restenotic coatings are disclosed. Specifically, implantable medical devices having coatings of certain antiproliferative agents, particularly a certain endothelin receptor inhibitor, are disclosed. The anti-restenotic endothelin receptor inhibitor is atrasentan, and pharmaceutically acceptable derivatives thereof. The anti-restenotic medical devices include stents, catheters, micro-particles, probes and vascular grafts. Intravascular stents are preferred medical devices. The medical devices can be coated using any method known in the art including compounding the endothelin receptor inhibitor with a biocompatible polymer prior to applying the coating. Moreover, medical devices composed entirely of biocompatible polymer-endothelin receptor inhibitor blends are disclosed. Additionally, medical devices having a coating comprising at least one endothelin receptor inhibitor in combination with at least one additional therapeutic agent are also disclosed. Furthermore, related methods of using and making the anti-restenotic implantable devices are also disclosed.

Claims

1. An implantable medical device for the treatment or inhibition of restenosis coated with an endothelin receptor inhibitor selected from the group consisting of atrasentan, and pharmaceutically acceptable derivatives thereof.

2. The medical device according to claim 1 selected from the group consisting of stents, catheters, micro-particles, probes and vascular grafts.

3. The medical device according to claim 2 wherein said stent is an intravascular stent, esophageal stent, urethral stent or biliary stent.

4. The medical device according to claim 3 coated with a biocompatible polymer.

5. An intravascular stent for site-specific, controlled-release delivery of a medicament for the treatment or inhibition of restenosis, said stent having a coating comprising a biocompatible polymer and an endothelin receptor inhibitor selected from the group consisting of atrasentan and pharmaceutically acceptable derivatives thereof.

6. The intravascular stent according to claim 5 wherein said coating comprises:

(a) between about 10 μ

g and 1.0 mg of an endothelin receptor inhibitor, and

(b) a biocompatible polymer,

wherein said endothelin receptor inhibitor and said biocompatible polymer are in a ratio relative to each other of between about 1;

1 to about 1;

10 (w/w).

7. The intravascular stent according to claim 5 wherein said stent has a metallic body.

8. The intravascular stent according to claim 5 wherein said coating comprises at least one additional therapeutic agent.

9. A method of treating or inhibiting restenosis comprising:

providing an intravascular stent having a coating comprising an endothelin receptor inhibitor selected from the group consisting of atrasentan and pharmaceutically acceptable derivatives thereof; and

implanting said intravascular stent into a blood vessel lumen at risk for restenosis wherein said endothelin receptor inhibitor is released into tissue adjacent said blood vessel lumen in a controlled release manner.

10. The method according to claim 9 wherein said coating comprises:

(a) between about 10 μ

g and 1.0 mg of endothelin receptor inhibitor, and

(b) a biocompatible polymer,

wherein said endothelin receptor inhibitor and said biocompatible polymer are in a ratio relative to each other of between about 1;

1 to about 1;

10 (w/w).

11. A method for producing a medical device comprising:

providing medical device to be coated;

compounding atrasentan or a pharmaceutically acceptable derivative thereof with a carrier compound; and

coating said medical device with said atrasentan or pharmaceutically acceptable derivative thereof compounded with said carrier compound.

12. The method according to claim 11 wherein said medical device is an intravascular stent.

13. The method according to claim 11 wherein said carrier compound is a biocompatible polymer.

14. The method according to claim 11 wherein said coating is performed in multiple steps.