Tissue-separating fatty acid adhesion barrier

• US 9,278,161 B2
• Filed: 10/19/2009
• Issued: 03/08/2016
• Est. Priority Date: 09/28/2005
• Status: Active Grant

• Current Assignee: Atrium Medical Corporation (Getinge AB)
• Original Assignee: Atrium Medical Corporation (Getinge AB)
• Inventors: Swanick, Thomas M., Ferraro, Joseph, Martakos, Paul, Faucher, Keith M., Bienkiewicz, Joe, Dale, Alicia
• Primary Examiner(s): Wax, Robert A
• Assistant Examiner(s): HELM, CARALYNNE E
• Application Number:
  US12/581,582
• Publication Number:
  US 20100183697A1
• Time in Patent Office: 2,332 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61K 9/10 Dispersions; Emulsions A61K9/06 takes precedence; composition of dispersions, emulsions A61K47/00
• CPC Class Codes: A61L 2420/02 Methods for coating medical devices
• CPC Class Codes: A61L 31/00 Materials for other surgical articles , e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices shape or structure of stent-grafts A61F2/07, of stents A61F2/82, of surgical gloves A61B42/00, of surgical drapes A61B46/00, of occluding devices A61B17/12022
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/145 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• 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 41/00 Drugs used in surgical methods, e.g. surgery adjuvants for preventing adhesion or for vitreum substitution
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

Exemplary embodiments of the present invention provide adhesion barriers having anti-adhesion and tissue fixating properties. The adhesion barriers are formed of fatty acid based films. The fatty acid-based films may be formed from fatty acid-derived biomaterials. The films may be coated with, or may include, tissue fixating materials to create the adhesion barrier. The adhesion barriers are well tolerated by the body, have anti-inflammation properties, fixate, well to tissue, and have a residence time sufficient to prevent post-surgical adhesions.

Claims

1. A tissue separating barrier, comprising:

an anti-adhesion material having tissue anti-adhesion characteristics, wherein the anti-adhesion material comprises fatty acids cross-linked directly to each other by an ester bond, wherein the anti-adhesion material is bioabsorbable; and

a tissue fixating material disposed on a surface of the anti-adhesion material;

wherein the fatty acids are fish oil fatty acids;

wherein the anti-adhesion material and the tissue fixating material form the tissue separating barrier in such a way that the tissue separating barrier is non-inflammatory and fixates to tissue, in vivo, for a duration of greater than 10 days; and

wherein the tissue fixating material comprises carboxymethylcellulose (CMC).

2. The tissue separating barrier of claim 1, wherein the fish oil fatty acids of the anti-adhesion material comprises one or more omega-3 fatty acids.

3. The tissue separating barrier of claim 1, wherein the carboxymethylcellulose (CMC) is sodium carboxymethylcellulose (Na-CMC).

4. The tissue separating barrier of claim 1, wherein the anti-adhesion material is a film and the tissue fixating material is disposed on only one side of the film.

5. The tissue separating barrier of claim 1, wherein the anti-adhesion material reduces inflammation otherwise associated with the tissue fixating material.

6. The tissue separating barrier of claim 1, further comprising a plasticizing agent.

7. The tissue separating barrier of claim 6, wherein the plasticizing agent comprises one of a group of glycerin, propylene glycol, poly ethylene glycol, triacetin citrate and triacetin.

8. The tissue separating barrier of claim 1, wherein the anti-adhesion material further comprises a therapeutic agent.

13. The tissue separating barrier of claim 4, wherein the fatty acid-derived biomaterial reduces inflammation otherwise associated with the tissue fixating material in absence of the fatty-acid based film.

9. A tissue separating barrier, comprising:

a film derived from a fatty acid-derived biomaterial comprising a fish oil; and

a tissue fixating material disposed throughout the film;

wherein the film comprises fish oil fatty acids cross-linked directly to each other by an ester bond;

wherein the film and the tissue fixating material form the tissue separating barrier in such a way that the tissue separating barrier is non-inflammatory and fixates to tissue, in vivo, for a duration of greater than 10 days; and

wherein the tissue fixating material comprises carboxymethylcellulose (CMC).

10. The tissue separating barrier of claim 9, wherein the tissue fixating material further comprises a tissue fixating coating surrounding the film.

11. The tissue separating barrier of claim 9, wherein the film is an omega-3 fatty acid based film.

12. The tissue separating barrier of claim 9, wherein the carboxymethylcellulose (CMC) is sodium carboxymethylcellulose (Na-CMC).

14. The tissue separating barrier of claim 9, wherein the tissue separating barrier has a residence time that is sufficient to prevent post-surgical adhesions.

15. The tissue separating barrier of claim 9, further comprising a plasticizing agent.

16. The tissue separating barrier of claim 15, wherein the plasticizing agent is selected from the group consisting of glycerin, propylene glycol, poly ethylene glycol, triacetin citrate and triacetin.

17. A method for preparing a tissue separating barrier formed of a film having tissue anti-adhesion characteristics and a tissue fixating material in such a way that the tissue separating barrier is non-inflammatory and fixates to tissue, in vivo, for a duration of greater than 10 days, the method comprising:

creating the film from fish oil, wherein the film comprises fish oil fatty acids cross-linked directly to each other by an ester bond;

providing the tissue fixating material; and

combining the film with the tissue fixating material to form the tissue separating barrier;

wherein the film is bioabsorbable; and

wherein the tissue fixating material comprises carboxymethylcellulose (CMC).

18. The method of claim 17, wherein the carboxymethylcellulose (CMC) is sodium carboxymethylcellulose (Na-CMC).

19. The method of claim 17, wherein the tissue fixating material is disposed on only one side of the film.

20. The method of claim 17, wherein the tissue fixating material coats the fatty-acid based film on more than one side of the fatty acid-based film.

21. The method of claim 17, wherein the tissue fixating material is disposed throughout the fatty-acid based film.

22. The method of claim 17, wherein the film reduces inflammation otherwise associated with the tissue fixating material.

23. The method of claim 17, further comprising a step of providing a plasticizing agent.

24. The method of claim 23, wherein the plasticizing agent comprises one of a group of glycerin, propylene glycol, poly ethylene glycol, triacetin citrate and triacetin.

25. The method of claim 17, wherein the film further comprises a therapeutic agent.

26. A tissue separating, comprising:

fatty-acid based particles derived from a fatty acid-derived biomaterial comprising fish oil; and

an aqueous base solution comprising a tissue coherent material, wherein the fatty-acid based particles comprise fish oil fatty acids cross-linked directly to each other by an ester bond;

wherein the fatty-acid based particles are mixed with the aqueous base solution to form the tissue separating barrier in such a way that the tissue separating barrier is non-inflammatory and coheres to tissue, in vivo, for a duration of greater than 10 days; and

wherein the tissue coherent material comprises carboxymethylcellulose (CMC).

27. The tissue separating barrier of claim 26, wherein the fatty-acid based particles are soaked in a therapeutic agent before being mixed with the aqueous base solution.

28. The tissue separating barrier of claim 26, wherein a mean particle size of the fatty-acid based particles is between about 1 micron and about 50 microns.

29. The tissue separating barrier of claim 28, wherein the mean particle size of the fatty-acid based particles is between about 1 micron and about 10 microns.

30. The tissue separating barrier of claim 26, wherein the fatty-acid based particles have a distribution of size of about 1-20 μ

m.

31. The tissue separating barrier of claim 26, wherein the fatty-acid based particles have a distribution of size of about 21-40 μ

m.

32. The tissue separating barrier of claim 26, wherein the fatty-acid based particles have a distribution of size of about 41-150 μ

m.

33. The tissue separating barrier of claim 26, wherein the fatty-acid based particles are omega-3 fatty acid based particles.

34. The tissue separating barrier of claim 26, wherein the carboxymethylcellulose (CMC) is sodium carboxymethylcellulose (Na-CMC).

35. A coating on a medical device, comprising:

an anti-adhesion material; and

a tissue fixating material disposed onto or throughout the anti-adhesion material;

wherein the anti-adhesion material comprises fish oil fatty acids cross-linked directly to each other by an ester bond;

wherein the anti-adhesion material is bioabsorbable;

wherein the tissue fixating material comprises carboxymethylcellulose (CMC);

wherein the tissue fixating material is not cross-linked; and

wherein the coating fixates to tissue in vivo for a duration of at least 10 days.

36. The coating of claim 35, wherein the tissue fixating material further comprises a plasticizing agent.

37. The coating of claim 36, wherein the plasticizing agent is selected from the group consisting of glycerin, propylene glycol, poly ethylene glycol, triacetin citrate and triacetin.

38. The coating of claim 35, wherein the coating has anti-adhesion characteristics.

39. The coating of claim 35, wherein the anti-adhesion material comprises one or more omega-3 fatty acids.

40. The coating of claim 39, wherein the one or more omega-3 fatty acids are selected from the group consisting of eicosapentaenoic acid (EPA), docosahexanoic acid (DHA), alpha-linolenic acid (ALA) and combinations thereof.

41. The coating of claim 35, wherein the anti-adhesion material further comprises fatty acids cross-linked to each other by lactone cross-links.

42. The coating of claim 35, wherein the carboxymethylcellulose (CMC) is sodium carboxymethylcellulose (Na-CMC).

43. The coating of claim 42, wherein the fish oil further comprises Vitamin E.

44. The coating of claim 35, wherein upon hydrolysis of the coating substantially non-inflammatory products are produced.

45. The coating of claim 35, wherein the medical device comprises one or more of a surgical mesh, a graft, a catheter balloon, a stand-alone film, or a stent.

46. The coating of claim 35, wherein the medical device comprises a surgical mesh.

47. The tissue separating barrier of claim 35, wherein the anti-adhesion material further comprises a therapeutic agent.

48. A tissue separating barrier, comprising an emulsion base, wherein the emulsion base comprises an aqueous solution, carboxymethylcellulose, fish oil, and particles, wherein the particles are comprised of fish oil fatty acids cross-linked directly to each other by an ester bond, and wherein the tissue separating barrier is non-inflammatory and fixates to tissue, in vivo, for a duration of greater than 10 days.