Medical devices to prevent or inhibit restenosis

• US 20050261762A1
• Filed: 05/05/2005
• Published: 11/24/2005
• Est. Priority Date: 05/21/2004
• Status: Abandoned Application

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Hezi-Yamit, Ayala
• Application Number:
  US11/123,266
• Publication Number:
  US 20050261762A1
• Time in Patent Office: Days
• US Class Current: 623/1.420
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/91541 Adjacent bands are arranged out of phase
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• 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 anti-inflammatory agents, are disclosed. The-anti-inflammatory agents are selected from the group consisting of ENMD-0997, gusperimus hydrochloride, BMS-561392, CP-461, RDP-58, CNI-1493, CEP-1347, CMT-3, prinomastat, rebimastat, leflunomide, BX-471, DF-1681, BXT-51072, M-40403, LY-293111 sodium, 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 anti-inflammatory agent with a biocompatible polymer prior to applying the coating. Moreover, medical devices composed entirely of biocompatible polymer-anti-inflammatory agent blends are disclosed. Medical devices having a coating comprising at least one anti-inflammatory agent 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 disclosed.

Claims

1. An implantable medical device for the prevention or inhibition of restenosis coated with an anti-inflammatory agent selected from the group consisting of ENMD-0997, gusperimus hydrochloride, BMS-561392, CP-461, RDP-58, CNI-1493, CEP-1347, CMT-3, prinomastat, rebimastat, leflunomide, BX-471, DF-1681, BXT-51072, M-40403, LY-293111 sodium, 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 the site-specific, controlled-release delivery of a medicament for the prevention or inhibition of restenosis, said stent having a coating comprising a biocompatible polymer and an anti-inflammatory agent selected from the group consisting of ENMD-0997, gusperimus hydrochloride, BMS-561392, CP-461, RDP-58, CNI-1493, CEP-1347, CMT-3, prinomastat, rebimastat, leflunomide, BX-471, DF-1681, BXT-51072, M-40403, LY-293111 sodium, 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 anti-inflammatory agent, and

(b) a biocompatible polymer,

wherein said anti-inflammatory agent 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 preventing or inhibiting restenosis comprising:

providing an intravascular stent having a coating comprising an anti-inflammatory agent selected from the group consisting of ENMD-0997, gusperimus hydrochloride, BMS-561392, CP-461, RDP-58, CNI-1493, CEP-1347, CMT-3, prinomastat, rebimastat, leflunomide, BX-471, DF-1681, BXT-51072, M-40403, LY-293111 sodium, and pharmaceutically acceptable derivatives thereof; and

implanting said intravascular stent into a blood vessel lumen at risk for restenosis wherein said anti-inflammatory agent 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 an anti-inflammatory agent, and

(b) a biocompatible polymer,

wherein said anti-inflammatory agent 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 an anti-inflammatory agent selected from the group consisting of ENMD-0997, gusperimus hydrochloride, BMS-561392, CP-461, RDP-58, CNI-1493, CEP-1347, CMT-3, prinomastat, rebimastat, leflunomide, BX-471, DF-1681, BXT-51072, M-40403, LY-293111 sodium, and pharmaceutically acceptable derivatives thereof, with a carrier compound; and

coating said medical device with said anti-inflammatory agent 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.