Hydrophobic cross-linked gels for bioabsorbable drug carrier coatings

• US 8,124,127 B2
• Filed: 10/16/2006
• Issued: 02/28/2012
• 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): Richter, Johann
• Assistant Examiner(s): KASSA, JESSICA M
• Application Number:
  US11/582,135
• Publication Number:
  US 20070202149A1
• Time in Patent Office: 1,961 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 coating for a medical device, wherein said coating comprises:

a hydrophobic, non-polymeric cross-linked gel, a therapeutic agent, and fatty acids, said gel configured to release said therapeutic agent at a desired release rate in vivo;

wherein said non-polymeric cross-linked gel is formed from one or more of eicosapentaenoic acid (EPA) and docosahexanoic acid (DHA); and

wherein said non-polymeric cross-linked gel comprises two or more of said fatty acids cross-linked directly to each other by one or more of lactone bonds or ester bonds.

2. The coating of claim 1, wherein said coating has an average drug loading of about 500-1500 micrograms per square inch after curing.

3. The coating of claim 2, wherein said coating has an average drug loading of about 1100-1300 micrograms per square inch after curing.

4. The coating of claim 2, wherein said coating releases said drug over a period of at least seven days.

5. The coating of claim 2, wherein said coating releases said drug over a period of at least fifteen days.

6. The coating of claim 2, wherein said coating releases said drug over a period of about 17 to about 20 days.

7. The coating of claim 1, wherein said coating has an average drug loading of about 300-800 micrograms per square inch after curing.

8. The coating of claim 7, wherein said coating has an average drug loading of about 400-500 micrograms per square inch after curing.

9. The coating of claim 7, wherein said coating releases said drug over a period of at least twenty days.

10. The coating of claim 7, wherein said coating releases said drug over a period of about 35 to about 45 days.

11. The coating of claim 1, wherein said coating has an average drug loading of about 150-350 micrograms per square inch after curing.

12. The coating of claim 11, wherein said coating releases said drug over a period of at least seven days.

13. The coating of claim 11, wherein said coating releases said drug over a period of about 10 to about 15 days.

14. The coating of claim 1, wherein said coating has an average drug loading of about 300-700 micrograms per square inch after curing.

15. The coating of claim 14, wherein said coating releases said drug over a period of at least twenty days.

16. The coating of claim 14, wherein said coating releases said drug over a period of about 25 to about 30 days.

17. A hydrophobic, non-polymeric cross-linked gel, wherein said gel comprises a therapeutic agent and fatty acids;

wherein said non-polymeric cross-linked gel comprises two or more of said fatty acids cross-linked to each other by one or more of lactone bonds or ester bonds; and

wherein said non-polymeric cross-linked gel does not require the use of external cross-linking agents.

18. The gel of claim 17 wherein said non-polymeric cross-linked gel is formed from one or more of eicosapentaenoic acid (EPA) and docosahexanoic acid (DHA).

19. A coating for a medical device, wherein said coating comprises a hydrophobic, non-polymeric cross-linked gel, a therapeutic agent and fatty acids;

wherein said non-polymeric cross-linked gel comprises a three-dimensional network of cross-linked fatty acids and glycerides; and

wherein said fatty acids and glycerides are cross-linked directly to each other by one or more of lactone bonds or ester bonds.