Biocompatible and hemocompatible polymer compositions

• US 20060088571A1
• Filed: 10/21/2004
• Published: 04/27/2006
• Est. Priority Date: 10/21/2004
• Status: Abandoned Application

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Udipi, Kishore, Chen, Mingfei, Cheng, Peiwen, Sundar, Ron
• Application Number:
  US10/970,171
• Publication Number:
  US 20060088571A1
• Time in Patent Office: Days
• US Class Current: 424/426
• CPC Class Codes: A61L 2300/252 Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
• 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 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

Biocompatible coatings for medical devices are disclosed. Specifically, polymer coatings designed to control the release of bioactive agents from medical devices in vivo are disclosed. The present application also discloses providing vascular stents with controlled release coatings and related methods for making these coatings. Additional embodiments of the present invention include stents coated with the disclosed copolymer(s) and peptide drugs. Methods for treating or inhibiting post-stent implantation restenosis in patients are also provided.

Claims

1. A medical device for providing the controlled release of an anti-restenotic drug comprising a vascular stent coated with an amphiphilic copolymer and an anti-restenotic drug.

2. An amphiphilic copolymer for providing controlled release coatings on medical devices comprising hydrophilic and hydrophobic polymers of the formula:

3. The amphiphilic copolymer according to claim 2 wherein R₁ comprises a C_1-100alkyl, a C_1-100 alkenyl, or H.

4. The amphiphilic copolymer according to claim 2 wherein R₂ is selected from the group consisting, methyl, ethyl, cyclohexyl, norbornyl, phenyl, benzyl and adamantyl.

5. The amphiphilic copolymer according to claim 2 wherein said substituent groups are selected from the group consisting of halogens, hydroxyl groups, carboxyl groups, alkoxy groups, oxygen, nitrogen, sulfur, phosphorous, gallium, iron, boron and one or more radioisotope of same.

6. A drug-containing controlled releasing coating for a medical device comprising the amphiphilic copolymer of claim 2 and a drug.

7. The drug-releasing coating of claim 6 wherein the amphiphilic copolymer is a poly(ethylene glycol) (PEG)-methacrylate-cyclohexyl methacrylate copolymer.

8. The drug-releasing coating of claim 6 wherein said drug is an anti-restenotic drug.

9. The drug-releasing coating of claim 8 wherein said drug is a peptide.

10. The drug-releasing coating of claim 6 wherein said medical device is a vascular stent.

11. A medical device for providing the controlled release of an anti-restenotic composition comprising:

a stent having a generally cylindrical shape comprising an outer surface, an inner surface, a first open end and a second open end and wherein at least one of said inner or outer surfaces are adapted to deliver an anti-restenotic effective amount of at least one drug to a tissue within a mammal.

12. The medical device according to claim 11 wherein said stent is mechanically expandable.

13. The medical device according to claim 11 wherein said stent is self expandable.

14. The medical device according to claim 11 wherein at least one anti-restenotic drug is present on both said inner surface and said outer surface of said stent.

15. The medical device according to claim 11 wherein at least one of said inner and outer surfaces are coated with an amphiphilic copolymer wherein said amphiphilic copolymer has a least one anti-restenotic drug incorporated therein and said amphiphilic copolymer releases said at least one anti-restenotic drug into said tissue of said mammal.

16. The medical device according to claim 11 wherein said stent is delivered to said tissue using a balloon catheter.

17. The medical device according to claim 11 wherein said tissue is an anatomical lumen.

18. The medical device according to claim 17 wherein said tissue is a blood vessel lumen.

19. A vascular stent coated with an amphiphilic copolymer coating containing an anti-restenotic amount of a anti-restenotic drug.

20. The vascular stent of claim 19 further comprising a parylene primer coat.

21. The vascular stent of claim 19 wherein said amphiphilic copolymer coating comprises a PEG methacrylate-cyclohexyl methacrylate polymer.

22. The vascular stent of claim 19 further comprising a poly(butyl) methacrylate topcoat.

23. The vascular stent of claim 19 wherein said anti-restenotic drug is a peptide.

24. The vascular stent of claim 23 wherein said peptide is in a concentration of between approximately 0.1% to 99% by weight of peptide-to-polymer.

25. The vascular stent according to claim 19 wherein said stent is delivered to a tissue of a mammal'"'"'s anatomical lumen using a balloon catheter.

26. A method of inhibiting restenosis in a mammal comprising the site specific delivery of at least one anti-restenotic drug.

27. The method according to claim 26 wherein said anti-restenotic drug is delivered to a site at risk for restenosis using a vascular stent.

28. The method according to claim 26 wherein said anti-restenotic drug is delivered to a site at risk for restenosis using an injection catheter.

29. A method for inhibiting restenosis comprising providing a vascular stent having a controlled release coating comprising an amphiphilic copolymer and an anti-restenotic effective amount of an anti-restenotic drug