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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 coupling agent known to create amide linkages between amines and carboxylic acids in the presence of a lower alkanol. Such treatment has been shown to be bactericidal when carried out at 40.degree. C. for over 1 hour. The sterilization treatment preferably employs EDC as a water-soluble coupling agent plus an optional coupling enhancer such as sulfo-NHS or NHS, in the presence of isopropanol or an equivalent alkanol. Such sterilization treatment is preferably carried out at a temperature above ambient temperature in a buffered aqueous solution. The treatment leaves no residuals other than ones which are nontoxic and biocompatible, does not affect the resistance of the tissue to thermal denaturation and to digestion by proteolytic enzymes, and surprisingly also increases the resistance of fixed biological tissue to calcification.

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First Claim