Bioprosthetic tissue with reduced 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 bioprosthetic tissue comprising:
an at least partially cross-linked biological tissue comprising one or more functional groups that have been reacted with an ethanolamine, a hydroxylysine, a taurine, a dextran sulfate, a chondroitin sulfate, a polyvinyl alcohol, a 3-deoxyglucosone, a hydrazine, an adipic hydrazide, and a heparin, wherein the functional groups are selected from the group consisting of an aldehyde and a carboxylic acid.