Films having improved characteristics and methods for their preparation and use

• US 5,931,165 A
• Filed: 02/06/1997
• Issued: 08/03/1999
• Est. Priority Date: 09/06/1994
• Status: Expired due to Fees

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: Fusion Medical Technologies Inc. (Baxter International Inc.)
• Inventors: Reich, Cary J., Dapper, Greg, Wallace, Donald G.
• Primary Examiner(s): Yu, Mickey
• Assistant Examiner(s): CAMPEN, KELLY SCAGGS
• Application Number:
  US08/795,744
• Time in Patent Office: 908 Days
• Field of Search: 606/229, 606/5, 606/6, 606/213-215, 128/898, 128/DIG. 8, 602/904, 623/11
• US Class Current: 128/898
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/07292 Reinforcements for staple line, e.g. pledgets
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 18/042 using additional gas becoming plasma
• CPC Class Codes: A61B 2017/00504 Tissue welding
• CPC Class Codes: A61B 2090/0816 for preventing adhesion
• CPC Class Codes: A61L 15/32 Proteins, polypeptides; Degradation products or derivatives thereof, e.g. albumin, collagen, fibrin, gelatin A61L15/225 takes precedence
• CPC Class Codes: A61L 15/325 Collagen
• CPC Class Codes: A61L 24/104 Gelatin
• CPC Class Codes: A61L 31/042 Polysaccharides
• CPC Class Codes: A61L 31/043 Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: A61L 31/045 Gelatin
• CPC Class Codes: A61L 31/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/141 Plasticizers
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

Gelatin film compositions are useful for immobilization over tissue, usually by the application of energy to the films. Exemplary films comprise cross-linked and non-cross-linked granular and non-granular gelatin sheets, typically including a plasticizer. The gelatin films are dry, thin, and preferably meet certain pliability, elasticity, melting temperature, and other criteria. Methods are described for producing these films from collagen. Methods are further described for applying these films to tissue.

Claims

1. A gelatin film characterized by:

a film thickness in the range from 0.03 mm to 0.2 mm;

a pliability in the range from 1 mN to 4 mN; and

at least one characteristic selected from the group consisting of;

a moisture content in the range from 11% to 16%;

an elasticity in the range from 30% to 150%;

a tensile strength in the range from 150 N/cm² to 260 N/cm² ;

a melting temperature in the range from 33°

C. to 40°

C.;

a collagenase digestion time in the range from 10 min. to 40 min, and

a degree of swelling (V/V_o) in the range from 4.5 to 6.5.

2. A gelatin film as in claim 1, wherein the gelatin is cross-linked.

3. A gelatin film as in claim 1, wherein the gelatin is granular.

4. A gelatin film as in claim 1, wherein the gelatin is non-granular.

5. A gelatin film as in claim 1, wherein the gelatin film comprises a plasticizer.

6. A gelatin film as in claim 5, wherein the gelatin comprises granular cross-linked gelatin having a plasticizer content in the range from 5% by weight to 40% by weight and a thickness in the range from 0.03 mm to 0.2 mm.

7. A gelatin film as in claim 6, consisting essentially of gelatin which has been produced from collagen and the plasticizer, where residual collagen may be present in the gelatin sheet.

8. A gelatin film as in claim 6, wherein the plasticizer is selected from the group consisting of polyethylene glycol, sorbitol, and glycerine.

9. A gelatin film as in claim 8, wherein the plasticizer is polyethylene glycol 400 at from 5% by weight to 40% by weight.

10. A package comprising:

a sterile sheet of gelatin film according to any one of claims 1 to 9; and

a container enclosing the gelatin sheet, wherein the sterility and moisture content of the gelatin film are preserved within the container.

11. A method for sealing tissue, said method comprising

positioning a film according to any of claims 1 to 9 to a target region in tissue;

and

applying energy to the film over a region and in an amount sufficient to immobilize the film on the tissue.

12. A method as in claim 11, wherein the target region is a surgical site.

13. A method as in claim 12, wherein the target region is in tissue selected from the group consisting of muscle, skin, epithelial tissue, connective or supporting tissue, nerve tissue, ophthalmic and other sense organ tissue, vascular and cardiac tissues, gastrointestinal organs and tissue, pleura and other pulmonary tissue, kidney, endocrine glands, male and female reproductive organs, adipose tissue, liver, pancreas, lymph, cartilage, bone, oral tissue, and mucosal tissue.

14. A method as in claim 12, wherein the surgical site is open to permit both positioning of the film and applying energy to the film.

15. A method as in claim 2, further comprising forming at least two percutaneous penetrations to the target region, introducing a viewing scope through one of said penetrations, viewing the target region using said viewing scope, positioning the film through another of the penetrations while viewing, and applying energy through another of said penetrations while viewing.

16. A method as in claim 11, further comprising a step of shaping the film to conform to the dimensions of the target region prior to positioning the film over said target region.