Compositions: coating or plastic – Coating or plastic compositions – Proteinaceous material containing
Patent
1997-11-28
1999-12-28
Szekely, Peter A.
Compositions: coating or plastic
Coating or plastic compositions
Proteinaceous material containing
1061401, 1061441, C08L 8900, C08L 108, C08L 511
Patent
active
060076135
DESCRIPTION:
BRIEF SUMMARY
The present invention relates to bioadhesives having a gelatin base and an aldehyde hardener; to a procedure for preparing the bioadhesives and to a device for their application; and also to hardeners for such adhesives.
The use of adhesives having a base of gelatin and resorcinol, hardened by an aldehyde (known generally as "GRA adhesives"), is known in the field of human and animal surgery, and particularly in the field of vascular surgery. More specifically, the use of GRF (gelatin-resorcinol-formol) adhesives has often been described in connection with the gluing of tissues (cf. RBM, Vol. 4, No. 2 (March/April 1982), page 147, and Nouvelle Presse Medicale, Vol. 4, No. 10 (Mar. 8, 1975).
The gelatin was selected primarily because of its innocuousness and because of its hemostatic properties, and also because of its ability to react with certain aldehydes, known as "hardeners". in order to form, by reticulation, an adhesive mass. The resorcinol also makes it possible to strengthen the quality of this type of adhesion.
The use of certain aldehydes (such as 37 percent officinal formol, 25 percent glutaraldehyde, or even a mixture of the latter two aldehydes in 9:1 ratio) is known; however, these aldehydes are utilized only in non-gel solution. These aldehydes have the disadvantage of being toxic at such concentrations (with an LD.sub.50 of 296 mg/kg for the formaldehyde and an LD.sub.50 of 33.7 mg/kg for the glutaraldehyde).
The use of such GRF adhesives requires that the surgeon first spread the gelatin/resorcinol (GR) mixture over the dry surfaces of the organ to be glued; then spray, instill, or deposit by small drops, with the aid of an intradermal syringe, the liquid hardener (i.e., the stabilized aqueous formaldehyde solution) onto the GR mixture; and finally apply the adhesive-coated surfaces to one another (cf. the CNIMH files, Vol. 6 (November-December 1984)). It is known that aqueous solutions of formaldehyde, glutaraldehyde, and glyceraldehyde, or mixtures thereof, can be utilized as liquid hardening agents.
This method requires a high degree of precision on the part of the surgeon, particularly because of the necrotic effect of the formol. In fact, the aspersion of formol onto living tissue not involved in the adhesive procedure causes damage and necroses that are often irreversible. Up till now, the surgical technique has consisted of very carefully protecting the adjacent tissue; however, these precautions often turn out to be insufficient. Furthermore, the risk of the surgeon's pricking himself with a syringe full of formol is always present; and, even at very low doses, an injection of formol causes a shock to the practitioner, who may therefore be required to interrupt the operation.
The present applicants have now developed a bioadhesive that remedies the major disadvantages of the known adhesives as described hereinabove.
Accordingly, the present invention relates to a bioadhesive that includes at least two constituents that are intended to be combined, for simultaneous, separate, or time-shifted use, i.e.:
1) A semi-liquid constituent (A) that includes, at a minimum, gelatin in an aqueous solution; and
2) A constituent (B), in gel or non-gel form, that includes, at a minimum, an aldehyde, with the exception of non-gel solutions consisting of formaldehyde, glutaraldehyde, or glyceraldehyde.
In a preferred embodiment of the invention, the constituent (B) is in gel form, and the disadvantages described hereinabove are avoided, in accordance with the invention, because hardeners in gel form are easier to handle than liquid hardeners, and prevent the risks of inadvertent aspersions and the consequent necroses, and do not require the use of the same syringes. The said adhesives are applied in connection with the gluing of human or animal tissues, and particularly in connection with the gluing of arteries and aortas.
The first constituent (A) is customarily utilized in GRA adhesives. It consists of an aqueous solution of gelatin in semi-liquid form. It may contain from 5 to 20 grams of gelatin
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Fusion Medical Technologies, Inc.
Szekely Peter A.
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