Perforated bioabsorbable oil film and methods for making the same

• US 8,574,618 B2
• Filed: 11/21/2012
• Issued: 11/05/2013
• 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 A
• Application Number:
  US13/682,991
• Publication Number:
  US 20130074452A1
• Time in Patent Office: 349 Days
• Field of Search: None
• US Class Current: 424/423
• 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 method of making a stand-alone film, said method comprising:

providing a non-porous stand-alone film 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;

forming one or more perforations in the film;

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 method of claim 1, wherein the one or more perforations is formed by cutting.

3. The method of claim 1, wherein the one or more perforations are formed by carving.

4. The method of claim 1, wherein the one or more perforations are formed by puncturing.

5. The method of claim 1, wherein the one or more perforations create a cavity in the film.

6. The method of claim 5, further comprising filling the cavity with a liquid, solid, gas or combination thereof.

7. The method of claim 1, further comprising sterilizing and packaging the film.

8. The method of claim 7, further comprising:

providing a pouch having a non-permeable chamber and a gas-permeable header;

placing the film in the pouch;

sealing the pouch along the gas-permeable header, such that the non-permeable chamber remains accessible through the gas-permeable header;

sterilizing the film with a sterilizing agent provided through the gas-permeable header to the non-permeable chamber;

sealing the film in the non-permeable chamber within the pouch; and

optionally removing the header, leaving the film packaged within the non-permeable chamber and sterilized.

9. The method of claim 8, wherein the sterilizing agent is selected from the group consisting of ethylene oxide (ETO) gas, radiation using gamma or electron-beam radiation, steam, gas plasma and vaporized hydrogen peroxide.

10. The method of claim 8, wherein after the gas permeable header is sealed, the method further comprises the step of purging the pouch with an inert gas prior to sealing the non-permeable chamber and removing the gas permeable header.

11. The method of claim 10, wherein the inert gas comprises argon or nitrogen.

12. The method of claim 8, wherein after the film is placed in the pouch the method further comprises the steps of:

exposing the pouch to vacuum conditions; and

purging the pouch with an inert gas prior to sealing the gas permeable header.

13. The method of claim 12, wherein the inert gas comprises argon or nitrogen.

14. The method of claim 8, wherein after the film is placed in the pouch, the method further comprises the steps of:

purging the pouch with an inert gas; and

exposing the pouch to vacuum conditions prior to sealing the gas permeable header.

15. The method of claim 14, wherein the inert gas comprises argon or nitrogen.

16. The method of claim 8, wherein prior to the sealing the gas permeable header, a desiccant, an oxygen scavenger, an oxygen barrier, or a combination thereof is added to the pouch.

17. The method of claim 16, wherein the desiccant is selected from the group consisting of silica gel, clay, molecular sieves, potassium permanganate, activated carbon, activated alumina, and a water absorbable polymer.