Medical devices to treat or inhibit restenosis

• US 20050154452A1
• Filed: 11/23/2004
• Published: 07/14/2005
• Est. Priority Date: 12/23/2003
• Status: Abandoned Application

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Trudel, Julie, Hezi-Yamit, Ayala, Singh, Sabeena
• Application Number:
  US10/997,633
• Publication Number:
  US 20050154452A1
• Time in Patent Office: Days
• US Class Current: 623/1.420
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 2300/216 with other specific functional groups, e.g. aldehydes, ketones, phenols, quaternary phosphonium groups
• 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 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

Implantable medical devices having anti-restenotic coatings are disclosed. Specifically, implantable medical devices having coatings of certain antiproliferative agents, particularly a certain isoflavonoid, are disclosed. The anti-restenotic isoflavonoid is phenoxodiol, 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 isoflavonoid with a biocompatible polymer prior to applying the coating. Moreover, medical devices composed entirely of biocompatible polymer-isoflavonoid blends are disclosed. Additionally, medical devices having a coating comprising at least one isoflavonoid 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 isoflavonoid selected from the group consisting of phenoxodiol, 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 isoflavonoid selected from the group consisting of phenoxodiol 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 isoflavonoid, and

(b) a biocompatible polymer,

wherein said isoflavonoid 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 isoflavonoid selected from the group consisting of phenoxodiol and pharmaceutically acceptable derivatives thereof; and

implanting said intravascular stent into a blood vessel lumen at risk for restenosis wherein said isoflavonoid 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 isoflavonoid, and

(b) a biocompatible polymer,

wherein said isoflavonoid 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 phenoxodiol or a pharmaceutically acceptable derivative thereof with a carrier compound; and

coating said medical device with said phenoxodiol 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.