Percutaneously Deliverable Heart Valve and Methods Associated Therewith

Abstract

An assembly configured for replacing an aortic or pulmonary heart valve in a human patient includes a transcatheter, prosthetic aortic or pulmonary heart valve. The transcatheter, prosthetic hear valve includes a frame that is expandable and collapsible, a tissue leaflet assembly sutured directly to the frame. The assembly also includes a percutaneously insertable valve delivery mechanism, wherein the transcatheter, prosthetic heart valve is releasably and coaxially mounted onto a balloon catheter of the percutaneously insertable valve delivery mechanism. The balloon catheter includes a guidewire lumen. The transcatheter, prosthetic heart valve releasably and coaxially mounted onto the balloon catheter are included in a sterile packaging to form the assembly.

What is claimed is: 
     
         1 . An assembly configured for replacing an aortic or pulmonary heart valve in a human patient, comprising:
 a transcatheter, prosthetic aortic or pulmonary heart valve, including:
 a frame that is expandable and collapsible; and 
 a tissue leaflet assembly sutured directly to the frame, wherein the tissue leaflet assembly includes three substantially dry leaflets, wherein a treated mammalian pericardial tissue used to form the three substantially dry leaflets has been treated with glutaraldehyde and glycerol, and wherein the treated mammalian pericardial tissue used to form the three substantially dry leaflets has a thickness of between about 50 to 300 μm; 
   a percutaneously insertable valve delivery mechanism, wherein the transcatheter, prosthetic aortic or pulmonary heart valve is releasably and coaxially mounted onto a balloon catheter of the percutaneously insertable valve delivery mechanism, wherein the balloon catheter has a size of 12 to 14 French, and wherein the balloon catheter includes a guidewire lumen; and   a sterile package containing the transcatheter, prosthetic aortic or pulmonary heart valve that is releasably and coaxially mounted onto the balloon catheter.   
     
     
         2 . The assembly of  claim 1 , wherein the frame comprises a stent. 
     
     
         3 . The assembly of  claim 1 , wherein the treated mammalian pericardial tissue has an ultimate tensile strength of greater than about 12 MegaPascals. 
     
     
         4 . The assembly of  claim 1 , wherein the treated mammalian pericardial tissue does not include a matrix that has been exposed to a polymer infiltrate. 
     
     
         5 . The assembly of  claim 1 , wherein the treated mammalian pericardial tissue has been treated with distilled water. 
     
     
         6 . The assembly of  claim 1 , wherein the treated mammalian pericardial tissue has been treated with isopropyl alcohol.