Importance

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Abstract

Improved, adaptable tissue-type heart valves and methods for their manufacture are disclosed wherein a dimensionally stable, pre-aligned tissue leaflet subassembly is formed and its peripheral edge clamped between and attached to an upper shaped wireform and a lower support stent. A variety of adaptable structural interfaces including suture rings, flanges, and conduits may be attached to the support stent with or without an outlet conduit disposed about the wireform to provide a tissue-type heart valve adaptable for use in either a natural heart or in mechanical pumping devices. The methods include forming individual leaflets with a template and using the template to attach the leaflets together to form a tissue leaflet subassembly. The template and leaflets include a straight edge terminating in oppositely directed tabs, and a curvilinear cusp edge extending opposite the straight edge. The template may include a guide slot in its straight edge and the assembly includes aligning two leaflet tabs with the template and passing sutures through the guide slot and through the leaflet tabs. The leaflet subassembly is mated to a wireform with the tabs extending through commissure posts of the wireform. A support stent having an upper surface matching the lower surface of the wireform sandwiches the edges of the leaflet subassembly therebetween. Separated tabs on the leaflet subassembly are passed through the wireform commissures and attached to adjacent stent commissures so as to induce clamping of the leaflet tabs between the stent commissures and wireform commissures upon a radially inward force being applied to the leaflets.

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First Claim