Adhesive composition with macromolecular polyaldehyde base and m

Details Adhesive composition with macromolecular polyaldehyde base and m Adhesive composition with macromolecular polyaldehyde base and m

1998-06-08

2000-12-26

Azpuru, Carlos A.

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Implant or insert

A61F 202

Patent

active

061654884

DESCRIPTION:

BRIEF SUMMARY
BACKGROUND OF THE INVENTION

(1) Field of the Invention
The present invention lies in the field of biodegradable and nontoxic biological adhesives intended for surgical or therapeutic use.
More precisely, the present invention deals with a biocompatible, bioresorbable and nontoxic adhesive composition based on at least one macromolecular polyaldehyde.
It also relates to such an adhesive composition additionally comprising a collagen-based component.
It also relates to a process for crosslinking solubilized collagen which makes it possible to obtain an adhesive material intended to be applied quickly to tissues and/or a biomaterial.
(2) Description of the Related Art
The crosslinking of collagen can be carried out either by a chemical route, with the aid of tanning agents such as glutaraldehyde or formaldehyde or alternatively diisocyanate or other reactants, or by using physical agents such as gamma, beta or ultraviolet radiations.
However, this last method is cumbersome and sometimes difficult to implement and, besides the crosslinking, it also produces scissions.
Insofar as the chemical route is concerned, treatment with glutaraldehyde (or formaldehyde) is the treatment most frequently employed for crosslinking collagen and consists in immersing powders, films, gels or more or less concentrated solutions of collagen in a solution of glutaraldehyde. It has a certain number of disadvantages, depending on the applications. The introduction of glutaraldehyde into an aqueous collagen-based structure can especially entail a rapid separation of excess glutaraldehyde by diffusion through the gel formed.
In surgery or therapy this gives rise to toxic reactions, resulting in tissue necrosis or less severe reactions, leading to poor or retarded cicatrization. This is the case with the collagen-based adhesive available on the market today.
In this adhesive, called GRF, the crosslinking of gelatin is produced by formaldehyde in the presence of resorcinol, the latter being used essentially to reduce the dissolving of the adhesive mass. This adhesive has been employed between the 1960s and the 1980s, but, in fact, its use in surgery is now restricted to a few rare applications where the benefit exceeds the risks (aortic dissection) because of the possibility of separation of the formaldehyde and because of its toxicity. An excessive quantity of formaldehyde is needed to obtain rapid crosslinking of the collagen-based gel and good adhesion to the surrounding tissues. This excess of formaldehyde is responsible for the poor biocompatibility of the GRF adhesive. It is therefore not possible today to generalize the use of this adhesive to the cicatrization of surgical or chronic wounds, to the protection or the leakproofing of sutures or to the release of medications.
A recent improvement has just been proposed, by increasing the viscosity of the medium which contains the formaldehyde, the glutaraldehyde or other dialdehyde by adding a gelling agent such as agar (G. Izoret patent application, Wo 96/14368). However, this does not eliminate the risk of diffusion of the crosslinking agent, even though the diffusion is slowed down.
Furthermore, the biocompatibility of collagen crosslinked with toxic chemical agents can be improved by reducing the quantity of crosslinking agents employed to a minimum. This is what is done in preformed materials intended to be implanted, where the reaction time can be prolonged as much as necessary by the manufacturer of the material. In this case small quantities of crosslinking agent are employed and the crosslinked material is carefully washed at the end of preparation to remove any excess of reactant.
The final crosslinked material employed by the surgeon is in this case a solid or a suspension of collagen-based fibres, but these materials are devoid of adhesiveness to the surrounding tissues.
The preparation of a biological adhesive often requires the mixing, by the surgeon himself, in contact with the biological tissues to be treated, of two different solutions permitting a rapid crosslinki

REFERENCES:
patent: 3057723 (1962-10-01), Jeffreys et al.
patent: 4970298 (1990-11-01), Silver et al.
"Gelatin-based adhesives for bookbinding", Chemical Abstracts, Abstract No. 85407, vol. 116, No. 10, Mar. 9, 1992.
"Some Aspects of the Crosslinking of Gelatin by Dextran Dialdehydes", Scht, et al. Polymer Gels and Networks, vol. 1, 1993, pp. 213-224.

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