Method of using cross-linked fibrin material

Details Method of using cross-linked fibrin material Method of using cross-linked fibrin material

1997-08-28

2000-06-13

Brouillette, D. Gabrielle

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Web, sheet or filament bases; compositions of bandages; or...

424422, 424423, 424424, 424426, A61F 1300

Patent

active

060746637

DESCRIPTION:

BRIEF SUMMARY
This application is a 371 of PCT/EP96/00160, filed Jan. 16, 1996.
The invention relates to a self-supporting sheet-like material of cross-linked fibrin and to processes for making said material. The invention also relates to the use of said material and of fibrin glues/sealants for the treatment of internal traumatic lesions, particularly for the prevention of post-operative adhesion formation.
One of the major problems in intra-abdominal surgery is the avoidance of post-operative adhesions. It is well-known that adhesions contribute to pain, immobility, retarded wound healing, and in particular to intestinal obstruction which even may be life-threatening. In the field of gynecological surgery, post-surgical adhesions involving female reproductive organs may result in infertility.
Each surgical procedure necessarily produces a wound such as in laparoscopy, where the abdominal wall is opened for an inspection of the abdominal cavity. Physiologically, the process of wound closure then starts when bleeding ceases upon formation of a haemostatic clot at the places, where blood vessels are injured. The clot, at first comprising mainly platelets, is solidified by a fibrin network resulting from the activation of an enzyme cascade involving thrombin, factor XIII and calcium. Further steps on the way to the sealing of the wound are retraction of the haemostatic clot, invasion of various cell types including fibroblasts into the wound area and eventually the lysis of the fibrin network. Adhesions are thought to be formed when the fibrin clot covering an injury comes into contact with an adjacent surface and the new connective tissue produced by the fibroblasts "glues" the two surfaces together.
The problems associated with adhesions often require a further operative procedure for removing/lysing the adhesions, called adhesiolysis, which, like the first operation, principally bears the risk that adhesions are caused. Accordingly, the prevention of adhesion formation is mandatory. Among the different approaches for prevention of adhesion formation, one involves the use of materials as a physical or bio-mechanical barrier for the separation or isolation of traumatized tissues during the healing process. Both synthetic materials and natural materials have been used as a barrier to adhesion formation. Permanent, inert implants like Gore-Tex surgical membranes consisting of expanded polytetrafluoroethylene (PTFE) generally require a second operative procedure to remove them, while others such as surgical membranes of oxidized regenerated cellulose are biodegradable, but are thought to elicit an inflammatory response ultimately leading to adhesion formation (A. F. Haney and E. Doty, Fertility and Sterility 60, 550-558, 1993). Other barrier materials that have been proposed for the prevention of adhesions include elastin-derived bioelastic matrixes (D. W. Urry et al., Mat. Res. Soc. Symp. Proc. 292, 1993) and mucopolysaccharide films (T. Matsuda et al., ASAIO Journal 38, M 154-157, 1992). However, complete prevention of adhesion formation using these two latter materials has not been reported so far.
On the other hand, (fluid) fibrin sealants/glues are well-known in the art for use in haemostasis, tissue sealing and wound healing and have been commercially available for more than a decade. Fibrin glues imitate the last step of the coagulation cascade and are usually commercialized as kits comprising two main components. The first component is a solution comprising fibrinogen and factor XIII, while the second component is a thrombin-calcium solution. After mixing of components, the fibrinogen is proteolytically cleaved by thrombin and thus converted into fibrin monomers. In the presence of calcium, Factor XIII is also cleaved by thrombin into its activated form (FXIIIa). FXIIIa cross-links the fibrin monomers to a three-dimensional network commonly called "Fibrin Gel". In order to avoid that a premature coagulation prevents/impairs the application of the fibrin glue, the two components are either mixed by means of special d

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