CROSS-LINKED FATTY ACID-BASED BIOMATERIALS

• US 20150209482A1
• Filed: 04/06/2015
• Published: 07/30/2015
• Est. Priority Date: 09/28/2004
• Status: Active Grant

• Current Assignee: Atrium Medical Corporation (Getinge AB)
• Original Assignee: Atrium Medical Corporation (Getinge AB)
• Inventors: FAUCHER, Keith M., TANG, Hui, MARTAKOS, Paul, HERWECK, Steve A., KARWOSKI, Theodore, SULLIVAN, Allison, MELVILLE, Greg, CORBEIL, Scott E.
• Granted Patent: US 9,827,352 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61K 31/4353 ortho- or peri-condensed with heterocyclic ring systems
• CPC Class Codes: A61L 2300/404 Biocides, antimicrobial agents, antiseptic agents
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 2420/06 Coatings containing a mixture of two or more compounds
• CPC Class Codes: A61L 2430/00 Materials or treatment for tissue regeneration
• CPC Class Codes: A61L 31/08 Materials for coatings
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• 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 37/00 Drugs for immunological or allergic disorders
• 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

Abstract

Fatty acid-based, pre-cure-derived biomaterials, methods of making the biomaterials, and methods of using them as drug delivery carriers are described. The fatty acid-derived biomaterials can be utilized alone or in combination with a medical device for the release and local delivery of one or more therapeutic agents. Methods of forming and tailoring the properties of said biomaterials and methods of using said biomaterials for treating injury in a mammal are also provided.

Claims

1. A coating for a medical device, comprising:

a cross-linked fatty acid oil, and a therapeutic agent, wherein the fatty acid was partially cross-linked before association with the therapeutic agent.

2. The coating of claim 1, wherein the therapeutic agent is contained within the coating in such a manner that the therapeutic agent has an enhanced release profile.

3. The coating of claim 1, further comprising pre-cured glyceride.

5. The coating of claim 1, wherein the oil comprises 5-25% C₁₄ fatty acids.

6. The coating of claim 1, wherein the oil comprises 5-30% C₁₆ fatty acids.

19. The coating of claim 1, wherein the coating is configured to produce a glyceride upon metabolization in-vivo.

4. A fatty-acid based, pre-cure-derived coating for a medical device, comprising:

a pre-cured, cross-linked fatty acid, comprising approximately 5-50% C₁₆ fatty acids.

7. A fatty-acid based, pre-cure-derived coating for a medical device comprising a non-polymeric, cross-linked fatty acid, comprising approximately 5-25% C₁₄ fatty acids and 5-50% C₁₆ fatty acids.

8. A fatty-acid based, pre-cure-derived coating for a medical device comprising cross-linked fatty acids and glycerides, wherein the fatty acids and glycerides have disordered alkyl groups, which cause the coating to be flexible and hydratable.

9. A fatty-acid based, pre-cure-derived for a medical device comprising a fatty acid-derived biomaterial, wherein the fatty acid-derived biomaterial comprises delta-lactones.

10. A fatty-acid based, pre-cure-derived coating for a medical device, wherein the coating comprises lactone and ester cross links, as indicated by an infrared absorption spectrum having peaks at approximately 1740-1850 cm⁻

1, respectively.

11. A fatty-acid based, pre-cure-derived coating for a medical device, comprising a cross-linked, fatty acid-derived biomaterial, wherein approximately 60-90% of the biomaterial is constituted by fatty acids with molecular weights below 500.

12. A fatty-acid based, pre-cure-derived biomaterial suitable for achieving modulated healing in a tissue region in need thereof, wherein the biomaterial is administered in an amount sufficient to achieve said modulated healing, wherein the modulated healing comprises a modulation of platelet or fibrin deposition in or near said tissue region.

13. The biomaterial of claim 12, wherein the tissue region is the vasculature of a subject.

18. The fatty-acid based, pre-cure-derived biomaterials of claim 12 or 14, wherein the composition is administered to the region in need thereof via a catheter, balloon, stent, surgical mesh, surgical dressing, or graft.

14. A fatty-acid based, pre-cure-derived biomaterial suitable for achieving modulated healing at a site of vascular injury in need thereof, wherein the composition is administered in an amount sufficient to achieve said modulated healing, wherein the modulated healing comprises a modulation of at least one metric of organized tissue repair.

15. The fatty-acid based, pre-cure-derived biomaterial of claim 14, wherein the vascular healing is the inflammatory stage of vascular healing.

16. The fatty-acid based, pre-cure-derived biomaterial of claim 14, wherein the organized tissue repair comprises platelet or fibrin deposition at the site of vascular injury.

17. The fatty-acid based, pre-cure-derived biomaterial of claim 14, wherein the modulation of at least one metric of organized tissue repair is a delay in the healing process at a site of vascular injury.