Medical devices to treat or inhibit restenosis

• US 20070142905A1
• Filed: 12/07/2006
• Published: 06/21/2007
• Est. Priority Date: 12/16/2005
• Status: Abandoned Application

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Wong, Jennifer, Sullivan, Carol, Hezi-Yamit, Ayala
• Application Number:
  US11/567,821
• Publication Number:
  US 20070142905A1
• Time in Patent Office: Days
• US Class Current: 623/1.420
• 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 2300/436 of receptors
• CPC Class Codes: A61L 27/34 Macromolecular materials
• 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 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61L 31/10 Macromolecular materials
• 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 NF-kappaB inhibitors, particularly certain dialkyl fumarates, are disclosed. Dimethyl fumarate is a particularly preferred dialkyl fumarate. 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 dialkyl fumarate with a biocompatible polymer prior to applying the coating. Moreover, medical devices composed entirely of biocompatible polymer-dialkyl fumarate blends are disclosed. Additionally, medical devices having a coating comprising at least one dialkyl fumarate 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 a dialkyl fumarate wherein each alkyl is independently straight or branched chain alkyl of from 1-4 carbon atoms.

2. The medical device according to claim 1 wherein both alkyl groups are identical.

3. The medical device according to claim 2 wherein both alkyl groups are methyl, i.e., dimethyl fumarate.

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

5. The medical device according to claim 4 wherein said stent is an intravascular stent, esophageal stent, urethral stent or biliary stent.

6. The medical device according to claim 5 coated with a biocompatible polymer.

7. 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 a dialkyl fumarate.

8. The intravascular stent according to claim 7 wherein the dialkyl fumarate is dimethyl fumarate.

9. The intravascular stent according to claim 7 wherein said coating comprises:

(a) between about 10 μ

g and 1.0 mg of a dialkyl fumarate, and

(b) a biocompatible polymer,

wherein said dialkyl fumarate and said biocompatible polymer are in a ratio relative to each other of between about 1;

1 to about 1;

10 (w/w).

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

11. The intravascular stent according to claim 7 wherein said coating comprises at least one additional therapeutic agent.

12. A method of treating or inhibiting restenosis comprising:

providing an intravascular stent having a coating comprising a dialkyl fumarate; and

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

13. The method according to claim 12 wherein the dialkyl fumarate is dimethyl fumarate.

14. The method according to claim 12 wherein said coating comprises:

(a) between about 10 μ

g and 1.0 mg of dialkyl fumarate, and

(b) a biocompatible polymer,

wherein said dialkyl fumarate and said biocompatible polymer are in a ratio relative to each other of between about 1;

1 to about 1;

10 (w/w).

15. A method for producing a medical device comprising:

providing medical device to be coated;

compounding dimethyl fumarate with a carrier compound; and

coating said medical device with said dimethyl fumarate compounded with said carrier compound.

16. The method according to claim 15 wherein said medical device is an intravascular stent.

17. The method according to claim 15 wherein said carrier compound is a biocompatible polymer.

18. The method according to claim 15 wherein said coating is performed in multiple steps.