摘要 |
<p>A treatment for bioprosthetic tissue used in implants or for assembled bi oprosthetic heart valves to reduce in vivo calcification is disclosed. The m ethod includes preconditioning, pre-stressing, or pre-damaging fixed biopros thetic tissue in a manner that mimics the damage associated with post- impla nt use, while, and/or subsequently applying a calcification mitigant such as a capping agent or a linking agent to the damaged tissue. The capping agent suppresses the formation of binding sites in the tissue that are exposed or generated by the damage process (service stress) and otherwise would, upon implant, attract calcium, phosphate, immunogenic factors, or other precursor s to calcification. The linking agent will act as an elastic reinforcement o r shock- absorbing spring element in the tissue structure at the site of dam age from the pre-stressing. In one method, tissue leaflets in assembled biop rosthetic heart valves are preconditioned by simulating actual flow conditio ns for a predetermined number of cycles, during or after which the valve is exposed to the capping agent.</p> |