Importance

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Abstract

Heart valves or other components for replacement of heart or other bodily organs and tissue prostheses or synthetic prosthetic materials are effectively sterilized by treatment with a carbodiimide coupling agent known to create amide linkages between amines and carboxylic acids. Such treatment has been shown to be bactericidal when carried out using an effective concentration of such a carbodiimide at a temperature of at least about 35.degree. C. for a sufficient period of time, e.g. treatment for about 9 hours at a concentration of at least about 50 mM. The sterilization treatment preferably employs EDC as a water-soluble coupling agent. Such sterilization treatment of biological tissue that has previously been fixed by subjection to stabilizing cross-linking is preferably carried out in a buffered aqueous solution and leaves no residuals other than ones which are nontoxic and biocompatible; moreover, it does not affect the desirable characteristics of resistance to thermal denaturation and to digestion by proteolytic enzymes, which are a product of such prior fixing, and may actually increase the resistance of such fixed biological tissue to degeneration and calcification.

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First Claim