Bioprosthetic heart valves having adaptive seals to minimize paravalvular leakage

Abstract

A packaged bioprosthetic heart valve comprising a bioprosthetic heart valve, an adaptive seal and a package. The bioprosthetic heart valve comprises an at least partially dehydrated biological tissue leaflet structure coupled to a supporting frame. The bioprosthetic heart valve has a periphery, an inflow portion, and an outflow portion. The adaptive seal is coupled to the bioprosthetic heart valve around at least a portion of the periphery. The adaptive seal comprises an expandable material that expands after exposure to an initiating condition. The bioprosthetic heart valve and the adaptive seal is stored and contained within the package, which does not contain a liquid storage solution in contact with the bioprosthetic heart valve and the adaptive seal.

Description

CROSS-REFERENCE TO RELATED APPLICATION[0001]This application claims the benefit of U.S. Patent Application No. 61 / 900,827, filed Nov. 6, 2013, the entire disclosure of which is incorporated by reference.FIELD OF THE INVENTION[0002]The invention relates to a heart valve prosthesis and, more particularly, to a heart valve prosthesis having an adaptive seal that minimizes perivalvular leakage following implantation.BACKGROUND[0003]Perivalvular leakage (PVL) is a complication that is related to the replacement of heart valves. It occurs when blood flows through a channel or gap between the structure of an implanted valve and the cardiac or arterial tissue due to a lack of appropriate sealing.[0004]Intimate apposition of replacement heart valves and the surrounding cardiac or arterial walls seals the valve and minimizes PVL. In certain cases, however, a seal cannot be achieved, leaving irregular gaps of different sizes and shapes between the valve and the cardiac or arterial walls. This ...

AI Technical Summary

Benefits of technology

[0007]Significant advantages are provided by the bioprosthetic heart valves disclosed herein, in which the biological tissue is treated so as to permit dry storage of the valves without a liquid storage solution. The adaptive seals can be exposed on the heart valve without requiring encapsulation or a barrier from the environment, as would be required if the valves were to be stored in a liquid preservation solution. To that end, the adaptive seals can simply comprise the expandable material exposed or contained within a permeable or semi-permeable material that permits fluid to come into contact with the expandable material, while supporting or containing the expandable material. In a preferred embodiment, the replacement heart valv

Problems solved by technology

Storage in liquid preservative solutions introduces a host of challenges for valves which include adaptive seals, particularly for those which are activated to expa

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