CAPPING BIOPROSTHETIC TISSUE TO REDUCE CALCIFICATION

摘要

A treatment for bioprosthetic tissue used in implants or for assembled bioprosthetic heart valves to reduce in vivo calcification. The method includes applying a calcification mitigant such as a capping agent or an antioxidant to the tissue to specifically inhibit oxidation in tissue. Also, the method can be used to inhibit oxidation in dehydrated tissue. The capping agent suppresses the formation of binding sites in the tissue that are exposed or generated by the oxidation and otherwise would, upon implant, attract calcium, phosphate, immunogenic factors, or other precursors to calcification. In one method, tissue leaflets in assembled bioprosthetic heart valves are pretreated with an aldehyde capping agent prior to dehydration and sterilization.

主权项

1. A method for mitigating calcification in a bioprosthetic tissue, the method comprising:
at least partially cross-linking the bioprosthetic tissue; treating the bioprosthetic tissue with a capping agent, wherein the capping agent reacts with functional groups associated with the bioprosthetic tissue; and treating the bioprosthetic tissue with a reducing agent, wherein the reducing agent reduces any Schiff bases created by the reaction of the capping agent and the functional groups associated with the bioprosthetic tissue.