Methods and compositions for inhibiting tissue adhesion

• US 5,791,352 A
• Filed: 11/08/1996
• Issued: 08/11/1998
• Est. Priority Date: 06/19/1996
• 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., Wallace, Donald, Dapper, Greg
• Primary Examiner(s): Millin, Vincent
• Assistant Examiner(s): CAMPEN, KELLY SCAGGS
• Application Number:
  US08/758,267
• Time in Patent Office: 641 Days
• Field of Search: 128/898, 606/2-4, 606/7-17, 606/213-215, 623/11, 602/904, 424/484, 424/486, 424/488, 424/426-428, 514/772.1, 514/772.3, 514/728, 514/729
• US Class Current: 128/898
• CPC Class Codes: A61B 2090/0816 for preventing adhesion
• CPC Class Codes: A61L 31/042 Polysaccharides
• CPC Class Codes: A61L 31/043 Proteins; Polypeptides; Degradation products thereof
• 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
• CPC Class Codes: Y10S 602/904 Film-forming bandage material

Abstract

Tissue adhesions are inhibited by applying and immobilizing a solid preformed matrix material over a target region, such as a surgical site, in a first tissue surface. The matrix material may be any continuous solid material, such as a sheet or film. After applying the material to the target region, the material is immobilized by applying energy over at least a portion of the surface of the matrix material which causes the material to fuse to the underlying tissue. The matrix material is preferably bioabsorbable so that it is resorbed by the body over time. Suitable matrix materials include proteins, polysaccharrides, and synthetic polymers.

Claims

1. A method for inhibiting the formation of adhesions between adjacent tissue surfaces, said method comprising:

exposing a target region on at least one of the tissue surfaces;

positioning a preformed, biocompatible, resorbable solid layer of matrix material having a thickness of about 0.01 mm to 2 mm over the target region;

applying about 2 W to 100 W energy to the matrix material over a region for approximately 5 seconds to 120 seconds and in an amount sufficient to immobilize the matrix material layer over the target region; and

permitting the adjacent tissue surface to reassume their natural juxtaposition, wherein the immobilized layer of matrix material inhibits adhesions therebetween.

2. A method as in claim 1, wherein the target region is a surgical site and at least one of the tissue surfaces is retracted to expose the target region.

3. A method as in claim 2, wherein the surgical site 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.

4. A method as in claim 2, wherein the surgical site is open to permit both positioning of the layer of matrix material and applying energy to the matrix material.

5. A method as in claim 1, wherein the target region is accessed by:

forming at least two percutaneous penetrations in close proximity to the target site;

introducing a viewing scope through one of said penetrations;

viewing the surgical site using said viewing scope;

positioning the matrix material through another of the penetrations while viewing; and

applying energy through another of said penetrations while viewing.

6. A method as in claim 1, further comprising a step of shaping the matrix layer to conform to the dimensions of the target region prior to positioning the layer over said target region.

7. A method as in claim 1, wherein the matrix material comprises at least one of a biologic polymer and a synthetic organic polymer.

8. A method as in claim 7, wherein the matrix material comprises a protein selected from the group consisting of collagen, gelatin, fibrin, fibrinogen, elastin, albumins, keratins, laminins, hemoglobins, and combinations thereof.

9. A method as in claim 7, wherein the matrix material comprises a polysaccharide selected from the group consisting of glycosaminoglycans, starch derivatives, cellulose derivatives, agarose, and alginate.

10. A method as in claim 7, wherein the matrix material comprises a non-biologic polymer selected from the group consisting of acrylates, methacrylates polyvinyl resins, polylactate-glycolides, polycaprolactones, and polyoxyethylenes, wherein the non-biological component of the matrix material has a molecular weight below approximately 10 kD.

11. A method as in claim 7, wherein the matrix material may optionally contain a plasticizer.

12. A method as in claim 11, wherein the plasticizer is selected from the group consisting of polyethylene glycol, sorbitol, and glycerine.

13. A method as in claim 12, wherein the matrix material comprises from 70% to 95% by weight collagen and from 5% to 30% by weight PEG with a molecular weight in the range from 200 to 3500.

14. A method as in claim 13, wherein the matrix material further comprises a plasticizer.

15. A method as in claim 12, wherein the matrix material comprises from 70% to 95% by weight gelatin and from 5% to 30% by weight PEG with a molecular weight in the range from 200 to 3500.

16. A method as in claim 15, wherein the matrix material further comprises a plasticizer.

17. A method as in claim 1, wherein the applied energy is selected from the group consisting of radio frequency energy, microwave energy, infrared energy, ultraviolet energy laser energy, and ultrasonic energy.

18. A method as in claim 17, wherein the energy applying step comprises directing energy from a radio frequency inert gas coagulator applicator against the target region.

19. A method as in claim 1, wherein the matrix material comprises collagen or gelatin and the energy is applied at a level from 1 W/cm² to 100 W/cm² for a time sufficient for the material to fuse to the tissue.

20. A method as in claim 1, wherein the energy is applied to selected locations on the solid layer of matrix material only, whereby the material is fused to tissue underlying the target region.

21. A method as in claim 20, wherein the energy is applied at least about the periphery of the solid layer of matrix material.

22. A method as in claim 1, wherein the energy is applied over substantially the entire exposed surface of the matrix material, whereby the material is uniformly fused to tissue underlying the target region.