Percutaneously implantable replacement heart valve device and method of making same

Abstract

A replacement heart valve device including a stent member that is to be compressible and expandable, and a dry valve directly sutured to the stent member. The dry valve includes two to four leaflets made of a treated pericardium tissue that has been gas sterilized.

What is claimed is: 
     
         1 . A replacement heart valve device, comprising:
 a stent member, the stent member configured to be compressible and expandable; and   a dry valve directly sutured to the stent member, wherein the dry valve includes two to four leaflets made of a treated pericardium tissue, and wherein the treated pericardium tissue has been gas sterilized.   
     
     
         2 . The replacement heart valve device of  claim 1 , wherein the stent member is self-expanding. 
     
     
         3 . The replacement heart valve device of  claim 1 , wherein the stent member is balloon expandable. 
     
     
         4 . The replacement heart valve device of  claim 1 , wherein the stent member is made of nitinol. 
     
     
         5 . The replacement heart valve device of  claim 1 , wherein the stent member is made of stainless steel. 
     
     
         6 . The replacement heart valve device of  claim 1 , wherein the stent member includes a tubular structure that flares at both ends in a trumpet-like configuration. 
     
     
         7 . The replacement heart valve device of  claim 1 , wherein the treated pericardium tissue comprises treated mammalian pericardium tissue. 
     
     
         8 . The replacement heart valve device of  claim 7 , wherein the treated pericardium tissue has been treated with glutaraldehyde. 
     
     
         9 . The replacement heart valve device of  claim 8 , wherein a pericardium tissue forming the dry valve has been subjected to light and mechanical compression to decrease the molecular distance of collagen fibers. 
     
     
         10 . An assembly for percutaneous and transluminal delivery of a medical implant, comprising:
 a delivery and implantation system including a flexible catheter; and   a replacement heart valve device residing within the flexible catheter and configured for delivery by the flexible catheter, the replacement heart valve device including:
 a stent member, the stent member configured to be compressible and expandable; and 
 a dry valve directly sutured to the stent member, wherein the dry valve includes two to four leaflets made of treated pericardium tissue, and wherein the treated pericardium tissue has been gas sterilized. 
   
     
     
         11 . The assembly of  claim 10 , wherein the stent member is self-expanding. 
     
     
         12 . The assembly of  claim 10 , wherein the stent member is balloon expandable. 
     
     
         13 . The assembly of  claim 10 , wherein the stent member is made of nitinol. 
     
     
         14 . The assembly of  claim 10 , wherein the stent member is made of stainless steel. 
     
     
         15 . The assembly of  claim 10 , wherein the stent member includes a tubular structure that flares at both ends in a trumpet-like configuration. 
     
     
         16 . The assembly of  claim 10 , wherein the treated pericardium tissue comprises treated mammalian pericardium tissue. 
     
     
         17 . The assembly of  claim 16 , wherein the treated pericardium tissue has been treated with glutaraldehyde. 
     
     
         18 . The assembly of  claim 17 , wherein a pericardium tissue forming the dry valve has been subjected to light and mechanical compression to decrease the molecular distance of collagen fibers.