Inverted Heart Valve for Transcatheter Valve Replacement

Abstract

A heart valve assembly for endovascular heart repair, where the valve is in an inverted position relative to the stent to reduce the diameter of the device for delivery and deployment. The heart valve assembly has an expandable stent and a valve. The valve having a proximal end and a distal end, the proximal end of the valve connected to the distal end of the expandable stent, wherein the valve extends distally from the distal end of the expandable stent.

What is claimed is: 
     
         1 . A heart valve assembly for endovascular heart repair, the heart valve assembly having a delivery position, the heart valve assembly comprising:
 an expandable stent having a proximal end and a distal end, the expandable stent having an outer surface and an inner surface defining a stent lumen; and   a valve in an inverted orientation in the delivery position, the valve having a proximal end and a distal end, the proximal end of the valve connected to the distal end of the expandable stent, the valve having an outer surface and an inner surface defining a valve lumen, wherein the valve extends distally from the distal end of the expandable stent.   
     
     
         2 . The heart valve assembly of  claim 1 , further comprising:
 at least one cable wire removably connected to the valve at least substantially near the distal end of the valve.   
     
     
         3 . The heart valve assembly of  claim 2 , wherein, after the expandable stent has been at least partially expanded, the at least one cable wire is pulled in a proximal direction to pull the distal end of the valve through the valve lumen and through at least a portion of the stent lumen to transpose the valve from the inverted orientation in the delivery position to a deployed position. 
     
     
         4 . The heart valve assembly of  claim 3 , further comprising:
 at least one locking feature on the expandable stent.   
     
     
         5 . The heart valve assembly of  claim 4 , wherein the at least one locking feature is substantially near the distal end of the expandable stent. 
     
     
         6 . The heart valve assembly of  claim 4 , wherein when the valve is in the deployed position, the at least one locking feature on the stent is engaged with the valve. 
     
     
         7 . The heart valve assembly of  claim 6 , wherein the at least one locking feature on the stent is engaged with the distal end of the valve. 
     
     
         8 . The heart valve assembly of  claim 6 , wherein when the locking feature on the stent is engaged with the valve, the at least one cable wire is disconnected from the valve. 
     
     
         9 . The heart valve assembly of  claim 1 , wherein the stent is a balloon expandable stent. 
     
     
         10 . The heart valve assembly of  claim 1 , wherein the stent is a self-expanding stent. 
     
     
         11 . The heart valve assembly of  claim 1 , wherein the valve comprises a tissue material. 
     
     
         12 . The heart valve assembly of  claim 1 , wherein the valve comprises a polymer. 
     
     
         13 . A method of endovascularly delivering a heart valve assembly, the method comprising:
 expanding the valve assembly from a delivery position into an expanded position, wherein the valve assembly comprises an expandable stent and an inverted valve having a proximal end connected to a distal end of the expandable stent, wherein the inverted valve extends distally from the distal end the expandable stent; and   pulling a distal end of the inverted valve through the valve lumen and at least a portion of the stent lumen to a deployed position using at least one cable wire connected to the inverted valve.   
     
     
         14 . The method of  claim 13 , further comprising:
 locking the distal end of the inverted valve to the stent.   
     
     
         15 . The method of  claim 14 , further comprising:
 releasing the at least one cable wire from the inverted valve.   
     
     
         16 . The method of  claim 15 , further comprising:
 recapturing the valve assembly through a sheath to reposition the valve assembly.   
     
     
         17 . The method of  claim 16 , further comprising:
 loading the valve into the sheath by pulling the valve proximally within the sheath.