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.

What is claimed is: 
     
         1 . A method for manufacturing a bioprosthetic heart valve comprising:
 providing a bioprosthetic heart valve comprising a biological tissue that has been treated with a treatment solution comprising a polyhydric alcohol, the bioprosthetic heart valve having a periphery, an inflow portion and an outflow portion;   coupling an adaptive seal to the bioprosthetic heart valve, the adaptive seal comprising an expandable material that expands after exposure to an initiating condition; and   packaging the bioprosthetic heart valve and the coupled adaptive seal in a package that does not contain a liquid storage solution in contact with the bioprosthetic heart valve and the coupled adaptive seal.   
     
     
         2 . The method of  claim 1 , wherein the polyhydric alcohol is glycerol. 
     
     
         3 . The method of  claim 1 , wherein the biological tissue is at least partially dehydrated following treatment with the treatment solution. 
     
     
         4 . The method of  claim 1 , wherein the adaptive seal is a hydrophilic polymer or a hydrogel-coated wire. 
     
     
         5 . The method of  claim 4 , wherein the hydrophilic polymer or the hydrogel-coated wire comprises a biodegradable cross-linker and wherein expansion of the adaptive seal is delayed for a period of time after exposure to the initiating condition. 
     
     
         6 . The method of  claim 1 , wherein the initiating condition is one or more selected from the group consisting of: a change in temperature, a change in the electrical field, a change in the magnetic field, a change in the chemical environment, a change in pH, and contact with a liquid. 
     
     
         7 . The method of  claim 1 , wherein the expandable material expands longitudinally, radially, or both longitudinally and radially relative to the bioprosthetic heart valve after exposure to the initiating condition. 
     
     
         8 . The method of  claim 1 , wherein the bioprosthetic heart valve comprises a stent and wherein the coupling comprises coating the stent with the adaptive seal or coupling patches within open cells defined by the stent. 
     
     
         9 . A packaged bioprosthetic heart valve comprising:
 a bioprosthetic heart valve comprising a dehydrated biological tissue leaflet structure coupled to a supporting frame, the bioprosthetic heart valve having a periphery, an inflow portion, and an outflow portion;   an adaptive seal coupled to the bioprosthetic heart valve, the adaptive seal comprising an expandable material that expands after exposure to an initiating condition;   a sealed package containing the bioprosthetic heart valve and the adaptive seal, wherein the package does not contain a liquid storage solution in contact with the bioprosthetic heart valve and the adaptive seal.   
     
     
         10 . The packaged bioprosthetic heart valve of  claim 10 , wherein the adaptive seal is a hydrophilic polymer or a hydrogel-coated wire. 
     
     
         11 . The packaged bioprosthetic heart valve of  claim 10 , wherein the adaptive seal is a hydrogel comprising a biodegradable cross-linker and wherein expansion of the adaptive seal is delayed for a period of time after exposure to the initiating condition. 
     
     
         12 . The packaged bioprosthetic heart valve of  claim 11 , wherein the adaptive seal is a hydrogel-coated wire comprising a shape memory metal, the hydrogel-coated wire changing from a first configuration to a second configuration upon reaching or exceeding a transformation temperature. 
     
     
         13 . The packaged bioprosthetic heart valve of  claim 12 , wherein in the first configuration, the hydrogel-coated wire has one of a straight or a coiled configuration and wherein in the second configuration, the hydrogel-coated wire has the other of the straight or coiled configuration. 
     
     
         14 . The packaged bioprosthetic heart valve of  claim 9 , wherein the adaptive seal is coupled to the bioprosthetic heart valve at a spaced distance from both of the inflow and outflow portions. 
     
     
         15 . The packaged bioprosthetic heart valve of  claim 9 , wherein the adaptive seal is provided circumferentially about the bioprosthetic heart valve. 
     
     
         16 . The packaged bioprosthetic heart valve of  claim 15 , wherein the bioprosthetic heart valve further comprises a sewing ring and wherein the adaptive seal is coupled to and exposed from the sewing ring or contained within the sewing ring. 
     
     
         17 . The packaged bioprosthetic heart valve of  claim 9 , wherein the supporting frame is a stent comprising a plurality of struts and open cells. 
     
     
         18 . The packaged bioprosthetic heart valve of  claim 17 , wherein the adaptive seal is coupled to one or more struts of the supporting frame. 
     
     
         19 . The packaged bioprosthetic heart valve of  claim 17 , wherein the adaptive seal forms one of a coating on at least a portion of the stent. 
     
     
         20 . The packaged bioprosthetic heart valve of  claim 17 , wherein the adaptive seal is provided as patches disposed within the open cells defined by the stent.