Percutaneously deliverable heart valve and methods associated therewith

Abstract

A prosthetic heart valve implantable by catheter without surgery includes a substantially “dry” membrane or tissue material. In at least one embodiment, the tissue is folded in a dry state to form a tissue leaflet assembly that is then attached to a frame to form an implantable prosthetic heart valve. Alternatively, one or more tissue leaflets are operatively associated with a frame to form an implantable prosthetic heart valve. The implantable prosthetic heart valve is subsequently pre-mounted on an integrated catheter delivery system. The catheter delivery system that includes the implantable prosthetic heart valve is then packaged and transported while the tissue remains dry. The implantable prosthetic heart valve, while remaining substantially dry, can then be implanted into the receiving patient.

1 .- 38 . (canceled) 
     
     
         39 . An assembly, comprising:
 a prosthetic heart valve including:
 a frame; and 
 a tissue leaflet assembly attached to the frame; and 
   a package containing the prosthetic heart valve and a delivery catheter, the prosthetic heart valve releasably secured to a portion of the delivery catheter.   
     
     
         40 . The assembly of  claim 39 , wherein the portion of the delivery catheter to which the prosthetic heart valve is releasably secured includes an expandable balloon. 
     
     
         41 . The assembly of  claim 39 , wherein the portion of the delivery catheter to which the prosthetic heart valve is releasably secured includes a mandrel. 
     
     
         42 . The assembly of  claim 39 , wherein the frame is self expanding. 
     
     
         43 . The assembly of  claim 39 , wherein tissue forming the tissue leaflet assembly comprises treated pericardium tissue. 
     
     
         44 . The assembly of  claim 43 , wherein the tissue leaflet assembly attached to the frame is at least one of hydrated and not substantially dry. 
     
     
         45 . The assembly of  claim 43 , wherein the tissue leaflet assembly attached to the frame is substantially dry. 
     
     
         46 . The assembly of  claim 45 , wherein the treated pericardium tissue has a moisture content of less than about 60% by weight of the treated pericardium tissue. 
     
     
         47 . The assembly of  claim 39 , wherein the frame comprises a stent. 
     
     
         48 . The assembly of  claim 39 , wherein the prosthetic heart valve resides within a sheath. 
     
     
         49 . An assembly, comprising:
 a prosthetic heart valve including:
 a frame; and 
 a tissue leaflet assembly attached to the frame, the tissue leaflet assembly comprising a substantially dry treated pericardium tissue; and 
   a package containing the prosthetic heart valve and a delivery catheter, the prosthetic heart valve releasably secured in a collapsed configuration to a portion of the delivery catheter, and wherein the prosthetic heart valve is expandable to an expanded configuration.   
     
     
         50 . The assembly of  claim 49 , wherein the portion of the delivery catheter to which the prosthetic heart valve is releasably secured includes an expandable balloon. 
     
     
         51 . The assembly of  claim 49 , wherein the portion of the delivery catheter to which the prosthetic heart valve is releasably secured includes a mandrel. 
     
     
         52 . The assembly of  claim 49 , wherein the frame is self expanding. 
     
     
         53 . The assembly of  claim 49 , wherein the substantially dry treated pericardium tissue has a moisture content of less than about 60% by weight of the substantially dry treated pericardium tissue. 
     
     
         54 . The assembly of  claim 49 , wherein the frame comprises a stent. 
     
     
         55 . The assembly of  claim 49 , wherein the prosthetic heart valve resides within a sheath. 
     
     
         56 . An assembly, comprising:
 a prosthetic heart valve including:
 a frame defining a lumen therein; and 
 a tissue leaflet assembly attached to the frame; and 
   a package containing the prosthetic heart valve and a delivery catheter, wherein a portion of the delivery catheter resides within the lumen of the frame.   
     
     
         57 . The assembly of  claim 56 , wherein the portion of the delivery catheter that resides within the lumen of the frame includes an expandable balloon. 
     
     
         58 . The assembly of  claim 56 , wherein the portion of the delivery catheter that resides within the lumen of the frame includes a mandrel. 
     
     
         59 . The assembly of  claim 56 , wherein the frame is self expanding. 
     
     
         60 . The assembly of  claim 56 , wherein tissue forming the tissue leaflet assembly comprises treated pericardium tissue. 
     
     
         61 . The assembly of  claim 60 , wherein the tissue leaflet assembly attached to the frame is at least one of hydrated and not substantially dry. 
     
     
         62 . The assembly of  claim 60 , wherein the tissue leaflet assembly attached to the frame is substantially dry. 
     
     
         63 . The assembly of  claim 62 , wherein the treated pericardium tissue has a moisture content of less than about 60% by weight of the treated pericardium tissue. 
     
     
         64 . The assembly of  claim 56 , wherein the frame comprises a stent. 
     
     
         65 . The assembly of  claim 56 , wherein the prosthetic heart valve resides within a sheath. 
     
     
         66 . The assembly of  claim 56 , wherein the portion of the delivery catheter that resides within the lumen of the frame is coaxial with the frame.