Hydrophobic cross-linked gels for bioabsorbable drug carrier coatings

• US 8,501,229 B2
• Filed: 02/24/2012
• Issued: 08/06/2013
• Est. Priority Date: 10/15/2005
• Status: Active Grant

• Current Assignee: Atrium Medical Corporation (Getinge AB)
• Original Assignee: Atrium Medical Corporation (Getinge AB)
• Inventors: Faucher, Keith M., Tang, Hui, Rogers, Lisa, Ferraro, Joseph, Martakos, Paul, Herweck, Steve A., Karwoski, Theodore
• Primary Examiner(s): Alstrum Acevedo, James H
• Assistant Examiner(s): KASSA, JESSICA M
• Application Number:
  US13/404,487
• Publication Number:
  US 20120213839A1
• Time in Patent Office: 529 Days
• Field of Search: None
• US Class Current: 424/484
• CPC Class Codes: A61L 2300/41 Anti-inflammatory agents, e.g. NSAIDs
• 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 2300/802 Additives, excipients, e.g. cyclodextrins, fatty acids, surfactants
• CPC Class Codes: A61L 29/08 Materials for coatings
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61L 31/08 Materials for coatings
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 7/02 Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system
• CPC Class Codes: B05D 3/0254 After-treatment

Abstract

Coatings for medical devices, methods of making the coatings, and methods of using them are described.

Claims

1. A medical device coating material comprising:

two or more fatty acids, wherein the two or more fatty acids are cross-linked to each other by ester bonds, wherein the coating material comprises one or more therapeutic agents, and wherein the coating hydrolyzes in vivo into substantially non-inflammatory compounds.

2. The coating material of claim 1, wherein the two or more fatty acids are omega-3 fatty acids.

3. The coating material of claim 2, wherein the omega-3 fatty acids are selected from the group consisting of eicosapentaenoic acid (EPA), docosahexanoic acid (DHA), alpha-linolenic acid (ALA), and combinations thereof.

4. The coating material of claim 1, further comprising a medical device, wherein the coating material is disposed on the medical device.

5. The coating material of claim 4, wherein the medical device is selected from the group consisting of stents, catheter balloons, surgical meshes and encapsulated surgical meshes.

6. The coating material of claim 1, wherein the substantially non-inflammatory compounds comprise one or more of free fatty acids and glycerols.

7. The coating material of claim 1, wherein upon hydrolysis of the coating in vivo the one or more therapeutic agents are released from the coating.

8. The coating material of claim 7, wherein the one or more therapeutic agents are released from the coating over a period of at least about seven days.

9. The coating material of claim 7, wherein the one or more therapeutic agents are released from the coating over a period of at least about fourteen days.

10. The coating material of claim 7, wherein the one or more therapeutic agents are released from the coating over a period of at least about twenty-one days.

11. The coating material of claim 1, further comprising vitamin E.

12. The coating material of claim 1, further comprising one or more of monoglycerides, diglycerides and triglycerides.

13. The coating material of claim 12, wherein the source of the one or more of monoglycerides, diglycerides and triglycerides is a fish oil.

14. The coating material of claim 1, wherein the source of the fatty acids is a fish oil.

15. The coating material of claim 1, further comprising two or more fatty acids cross-linked to each other by lactone bonds.

16. A method of treating a vascular injury of a subject, wherein the method comprises:

positioning a medical device proximal the vascular injury, the medical device coated with a material comprising two or more fatty acids cross-linked to each other by ester bonds, wherein the coating material comprises one or more therapeutic agents, and wherein the coating hydrolyzes in vivo into substantially non-inflammatory compounds; and

deploying the medical device at the location of the vascular injury of the subject to thereby treat the vascular injury.

17. The method of claim 16, wherein the vascular injury is selected from the group consisting of atherosclerosis, vascular occlusions, restenosis, and combinations thereof.

18. The method of claim 16, wherein the therapeutic agent is selected from the group consisting of an anti-inflammatory agent, an anti-coagulant agent, an anti-proliferative agent, an anti-neoplastic agent and combinations thereof.

19. A medical device coating material comprising two or more fatty acids, wherein the two or more fatty acids are cross-linked to each other by one or more of ester bonds and lactone bonds, and wherein the coating is bio-absorbable.

20. The coating material of claim 19, further comprising one or more therapeutic agents.

21. The coating material of claim 19, wherein the coating hydrolyzes in vivo into substantially non-inflammatory compounds selected from the group consisting of free fatty acids, glycerols, and combinations thereof.

22. The coating material of claim 19, further comprising esters of fatty acids.

23. The coating material of claim 19, wherein the coating is hydrophobic.

24. The coating material of claim 19, further comprising one or more of monoglycerides, diglycerides and triglycerides, wherein the fatty acids and the one or more of monoglycerides, diglycerides and triglycerides are covalently cross-linked in a substantially random configuration.

25. The coating material of claim 24, wherein the source of the fatty acids and the one or more of monoglycerides, diglycerides and triglycerides is an oil containing starting material, and wherein the oil containing starting material is a fish oil.