Perforated fatty acid films

• US 8,367,099 B2
• Filed: 09/22/2006
• Issued: 02/05/2013
• Est. Priority Date: 09/28/2004
• Status: Active Grant

• Current Assignee: Atrium Medical Corporation (Getinge AB)
• Original Assignee: Atrium Medical Corporation (Getinge AB)
• Inventors: Herweck, Steve A., Swanick, Thomas M., Ferraro, Joseph, Martakos, Paul, Rogers, Lisa, Karwoski, Theodore, Faucher, Keith M., McNamara, Philip, Labrecque, Roger, Conroy, Suzanne, Carlton, Trevor
• Primary Examiner(s): Azpuru, Carlos
• Application Number:
  US11/525,390
• Publication Number:
  US 20070071798A1
• Time in Patent Office: 2,328 Days
• Field of Search: None
• US Class Current: 424/447
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/320044 Blunt dissectors blunt suture needles A61B2017/06085
• CPC Class Codes: A61B 2090/0816 for preventing adhesion
• CPC Class Codes: A61F 2/0059 Cosmetic or alloplastic implants A61F2/10 - A61F2/16, A61F2/28 take precedence
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• CPC Class Codes: A61L 2/07 Steam
• CPC Class Codes: A61L 2/081 Gamma radiation
• CPC Class Codes: A61L 2/087 Particle radiation, e.g. electron-beam, alpha or beta radiation
• CPC Class Codes: A61L 2/14 Plasma, i.e. ionised gases
• CPC Class Codes: A61L 2/186 Peroxide solutions
• CPC Class Codes: A61L 2/206 Ethylene oxide
• CPC Class Codes: A61L 2/208 Hydrogen peroxide
• CPC Class Codes: A61L 2202/24 Medical instruments, e.g. endoscopes, catheters, sharps
• 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 31/145 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: B26F 1/18 Perforating by slitting, i.e. forming cuts closed at their ends without removal of material
• CPC Class Codes: B29C 39/02 for making articles of definite length, i.e. discrete articles
• CPC Class Codes: B65B 31/04 Evacuating, pressurising or gasifying filled containers or wrappers by means of nozzles through which air or other gas, e.g. an inert gas, is withdrawn or supplied
• CPC Class Codes: B65B 55/18 : by liquids or gases B65B55/14 takes precedence
• CPC Class Codes: Y10T 83/0481 : Puncturing

Abstract

A bio-absorbable stand-alone film is derived at least in part from fatty acids. The bio-absorbable stand-alone film can have anti-adhesive, anti-inflammatory, non-inflammatory, and wound healing properties, and can additionally include one or more therapeutic agents incorporated therein. The stand-alone film has one or more perforations or depressions formed therein. Corresponding methods of making the bio-absorbable stand-alone film with one or more perforations or depressions include molding, cutting, carving, puncturing or otherwise suitable methods to create the perforations or depressions in the bio-absorbable stand-alone film. The resulting stand-alone film is bioabsorbable.

Claims

1. A stand-alone film, comprising:

a film structure having a first side and a second side and formed of a non-polymeric cross-linked gel material formed at least in part of a fatty acid compound or derivative or analog thereof, and one or more perforations provided in the film structure;

wherein at least one of the one or more perforations comprises a slit that passes through the film from the first side through to the second side, or vice versa.

2. The stand-alone film of claim 1, wherein the fatty acid compound comprises omega-3 fatty acid, fish oil fatty acid, free fatty acid, triglycerides, esters of fish oil, or a combination thereof.

3. The stand-alone film of claim 2, wherein the fish oil fatty acid comprises one or more of arachidic acid, gadoleic acid, arachidonic acid, eicosapentaenoic acid, docosahexaenoic acid or derivatives, analogs and pharmaceutically acceptable salts thereof.

4. The stand-alone film of claim 2, wherein the free fatty acid comprises one or more of butyric acid, caproic acid, caprylic acid, capric acid, lauric acid, myristic acid, palmitic acid, palmitoleic acid, stearic acid, oleic acid, vaccenic acid, linoleic acid, alpha-linolenic acid, gamma-linolenic acid, behenic acid, erucic acid, lignoceric acid, analogs and pharmaceutically acceptable salts thereof.

5. The stand-alone film of claim 1, further comprising a vitamin E compound forming a portion of the fatty acid compound.

6. The stand-alone film of claim 5, wherein the vitamin E compound comprises one or more of alpha-tocopherol, beta-tocopherol, delta-tocopherol, gamma-tocopherol, alpha-tocotrienol, beta-tocotrienol, delta-tocotrienol, gamma-tocotrienol, alpha-tocopherol acetate, beta-tocopherol acetate, gamma-tocopherol acetate, delta-tocopherol acetate, alpha-tocotrienol acetate, beta-tocotrienol acetate, delta-tocotrienol acetate, gamma-tocotrienol acetate, alpha-tocopherol succinate, beta-tocopherol succinate, gamma-tocopherol succinate, delta-tocopherol succinate, alpha-tocotrienol succinate, beta tocotrienol succinate, delta- tocotrienol succinate, gamma-tocotrienol succinate, mixed tocopherols, vitamin E TPGS, derivatives, analogs and pharmaceutically acceptable salts thereof.

7. The stand-alone film of claim 1, further comprising a therapeutic agent, wherein the therapeutic agent comprises an agent selected from the group consisting of analgesics, antioxidants, anti-inflammatory agents, anti-coagulant agents, drugs to alter lipid metabolism, anti-proliferatives, anti-neoplastics, tissue growth stimulants, functional protein/factor delivery agents, anti-infective agents, imaging agents, anesthetic agents, chemotherapeutic agents, tissue absorption enhancers, anti-adhesion agents, germicides, analgesics, prodrugs, and antiseptics.

8. The stand-alone film of claim 7, wherein the therapeutic agent is combined with the fatty acid compound prior to formation of the film, resulting in the therapeutic agent being interspersed throughout the film.

9. The stand-alone film of claim 7, wherein the therapeutic agent is applied to the film in the form of a coating.

10. The stand-alone film of claim 1, wherein the film is bioabsorbable.

11. The stand-alone film of claim 1, wherein the one or more perforations form a regular pattern.

12. The stand-alone film of claim 1, wherein the one or more perforations have regular shapes.

13. The stand-alone film of claim 1, wherein at least one of the one or more perforations includes a cavity for holding a liquid.

14. The stand-alone film of claim 1, wherein at least one of the one or more perforations creates an opening in the film adapted to allow a body part to pass through the film.

15. The stand-alone film of claim 1, wherein at least one of the one or more perforations creates an opening in the film adapted to allow a surgical instrument to pass through the film without damaging the film.

16. The stand-alone film of claim 1, wherein at least one of the one or more perforations creates an opening in the film adapted to allow a fluid to pass through the film without damaging the film.

17. The stand-alone film of claim 1, wherein at least one of the one or more perforations has a cavity adapted to hold one or more solid particles.

18. The stand-alone film of claim 1, wherein at least one of the one or more perforations is adapted to contain a liquid with a solid particle.

19. The stand-alone film of claim 1, further comprising:

a first coating disposed on the first side of the film.

20. The stand-alone film of claim 19, wherein the first coating penetrates at least one of the one or more perforations.

21. The stand-alone film of claim 19, wherein the first coating covers at least a portion of the first surface.

22. The stand-alone film of claim 19, further comprising:

a second coating disposed on the second side of the film.

23. The stand-alone film of claim 22, wherein the first coating is materially different from the second coating.

24. The stand-alone film of claim 19, further comprising:

a second coating disposed on top of at least a portion of the first coating.

25. The stand-alone film of claim 1, wherein the film is sterilized.

26. The stand-alone film of claim 1, wherein the film is packaged.

27. The stand-alone film of claim 1, wherein the one or more perforations allows the film to conform to a three-dimensional surface of a tissue without tearing the film.

28. A stand-alone film, comprising:

a film structure having a first side and a second side and formed of a non-polymeric cross-linked gel material formed at least in part of a fatty acid compound or derivative or analog thereof; and

one or more depressions molded in the film structure on the first side and/or the second side;

wherein at least one of the one or more depressions comprises a slit that passes through the film from the first side through to the second side, or vice versa.

29. The stand-alone film of claim 28, wherein the film is sterilized.

30. The stand-alone film of claim 28, wherein the film is packaged.

31. The stand-alone film of claim 28, further comprising:

a first coating disposed on at least a portion of the first surface of the film.