Bioresorbable oxidized cellulose composite material for prevention of postsurgical adhesions

• US 6,500,777 B1
• Filed: 06/25/1997
• Issued: 12/31/2002
• Est. Priority Date: 06/28/1996
• Status: Expired due to Term

• Current Assignee: Ethicon Incorporated (Johnson & Johnson)
• Original Assignee: Ethicon Incorporated (Johnson & Johnson)
• Inventors: Saferstein, Lowell, Wolf, Stephen, Wiseman, David M.
• Primary Examiner(s): Gallagher, John J.
• Application Number:
  US08/881,972
• Time in Patent Office: 2,015 Days
• Field of Search: 156/336, 156/281, 442/286, 442/304, 442/394, 442/FOR.12, 424/444, 604/304
• US Class Current: 442/286
• CPC Class Codes: A61K 9/70 Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug hollow drug-filled fibres A61K9/0092
• CPC Class Codes: A61L 15/28 Polysaccharides or their derivatives A61L15/225 takes precedence
• CPC Class Codes: A61L 31/042 Polysaccharides
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: C08L 1/04 Oxycellulose; Hydrocellulose , e.g. microcrystalline cellulose
• CPC Class Codes: Y10T 442/3854 Woven fabric with a preformed polymeric film or sheet
• CPC Class Codes: Y10T 442/40 Knit fabric [i.e., knit strand or strip material]
• CPC Class Codes: Y10T 442/674 Nonwoven fabric with a preformed polymeric film or sheet

Abstract

An improved adhesion-preventative physical barrier, wound dressing and drug delivery system comprising an oxidized cellulose film made up of multiple layers of a cellulose fabric or like material and a cellulose film. A method for forming an improved oxidized cellulose film and for using the same to prevent the formation of postsurgical adhesions and/or to dress a wound and/or to deliver one or more drugs.

Claims

1. A method for forming an oxidized cellulose multi-layered bioresorbable film for use as an adhesion-preventative barrier, comprising the steps of:

spreading a cellulose film onto a surface;

combining at least one layer of a cellulose fabric material with said cellulose film with an adhesive material capable of oxidation to form a bioresorbable material to form a multi-layered film;

oxidizing the multi-layered film; and

sterilizing the multi-layered film.

2. The method of claim 1, wherein the adhesive is selected from the group consisting of starch, guar, dextran, ethylcellulose, cellulose monoacetate, carboxymethylcellulose, hydroxyethylcellulose, hydroxypropylmethylcellulose, hydroxybutylmethylcellulose, hydroxypropylcellulose and microcrystalline cellulose.

3. The method of claim 1, wherein the cellulose film is selected from the group consisting of cellulose films, cellulose acetate films, carboxymethylcellulose films, guar films, konjac films, starch films, dextran films and methylcellulose films.

4. The method of claim 1, wherein oxidizing includes exposing the multi-layered film to nitrogen dioxide.

5. The method of claim 4, wherein the multi-layered film is exposed to nitrogen dioxide for between 4 and 48 hours.

6. The method of claim 4, wherein the multi-layered film is exposed to nitrogen dioxide under a pressure of between 1 and 5 atmospheres.

7. The method of claim 4, wherein the multi-layered film is exposed to nitrogen dioxide in a temperature of between 20°

C. and 35°

C.

8. The method of claim 1, further including the step of washing the multi-layered film after the oxidizing step and before the sterilizing step.

9. The method of claim 8, wherein the multi-layered film is washed with an isopropanol solution.

10. The method of claim 1, wherein sterilizing the multi-layered film employs gamma irradiation.

11. The oxidized cellulose multi-layered film produced by the method of claim 1.

12. The method of claim 1, further including the step of plasticizing the multi-layered film with at least one polyhydroxy alcohol to impart flexibility to the multi-layered film.

13. The method of claim 12, wherein the at least one polyhydroxy alcohol is selected from the group consisting of glycerol and propylene glycol.

14. The method of claim 1, wherein the step of combining at least one layer of a cellulose fabric material with said cellulose film to form a multi-layered film includes the use of a rip stop material.

15. A method for forming an oxidized cellulose multi-layered bioresorbable film for use as an adhesion-preventative barrier, comprising the steps of:

spreading a cellulose film onto a surface;

combining at least one layer of a cellulose fabric material with said cellulose film using an oxidizable carbohydrate adhesive material capable of oxidation to produce a bioresorbable material to form a multi-layered film;

oxidizing the multi-layered film in the presence of nitrogen dioxide for between 4 and 48 hours at a temperature of between 20°

C. and 35°

C. and a pressure of between 1 and 5 atmospheres; and

sterilizing the multi-layered film.

16. The method of claim 15, wherein the cellulose film is selected from the group consisting of cellulose films, cellulose acetate films, starch films, guar films, konjac films, dextran films, carboxymethylcellulose films and methylcellulose films.

17. The method of claim 15, wherein the adhesive is selected from the group consisting of methylcellulose, carboxymethylcellulose, hydroxyethylcellulose, starch, guar, dextran, konjac and microcrystalline cellulose.

18. The method of claim 15, further including the step of washing the multi-layered film with an isopropanol solution after the oxidizing step and before the sterilizing step.

19. The method of claim 15, wherein sterilizing the multi-layered film employs irradiation.

20. The oxidized cellulose multi-layered film produced by the method of claim 15.

21. The method of claim 15, further including the step of plasticizing the multi-layered film with at least one polyhydroxy alcohol to impart flexibility to the multi-layered film.

22. The method of claim 21, wherein the at least one polyhydroxy alcohol is selected from the group consisting of glycerol and propylene glycol.

23. The method of claim 15, wherein the step of combining at least one layer of a cellulose fabric material with said cellulose film to form a multi-layered film includes the use of a rip stop material.