Method of deploying a percutaneous replacement heart valve

Abstract

A method of making a replacement heart valve device whereby a fragment of biocompatible tissue material is treated and soaked in one or more alcohol solutions and a solution of glutaraldehyde. The dried biocompatible tissue material is folded and rehydrated in such a way that forms a two- or three-leaflet/cusp valve without affixing of separate cusps or leaflets or cutting slits into the biocompatible tissue material to form the cusps or leaflets. After the biocompatible tissue material is folded, it is affixed at one or more points on the outer surface to the inner cavity or a stent.

1 .- 33 . (canceled) 
     
     
         34 . A method of deploying a percutaneous replacement heart valve in a patient where a bioprosthetic heart valve is indicated, comprising:
 providing a replacement heart valve device and a delivery and implantation system:
 the replacement heart valve device including:
 a stent member that is collapsible, expandable and configured for percutaneous delivery; and 
 a valve attached to the stent member, the valve including two to four individual leaflets; 
 
 the delivery and implantation system including:
 a balloon catheter and a moveable sheath, wherein the balloon catheter includes a lumen for receiving a guide wire, wherein the moveable sheath includes a lumen configured for receiving the balloon catheter, and wherein the replacement heart valve device is collapsed onto the balloon catheter to reside in a collapsed configuration on the balloon catheter and is restrained in a collapsed configuration by the moveable sheath; 
 
   after the providing step, guiding the delivery and implantation system over the guide wire within the patient to position the replacement heart valve device for deployment within the patient, wherein the replacement heart valve device remains collapsed onto the balloon catheter and continues to be restrained in the collapsed configuration by the moveable sheath;   after the guiding step, partially deploying a distal portion of the replacement heart valve device within the patient by partially exposing the replacement heart valve device from the moveable sheath;   after the partially deploying step, restraining the replacement heart valve device so that it does not pop out and is held for controlled release, with a potential that the replacement heart valve device can be recovered if there is a problem with positioning; and   after the restraining step, the replacement heart valve device is at the desired position, slightly retracting the moveable sheath to release the replacement heart valve device from the moveable sheath to allow the replacement heart valve device to fully expand.   
     
     
         35 . The method of  claim 34 , wherein partially exposing the replacement heart valve device from the moveable sheath comprises pushing out the balloon catheter from the moveable sheath to expose a portion of the replacement heart valve device from the moveable sheath. 
     
     
         36 . The method of  claim 34 , wherein partially exposing the replacement heart valve device from the moveable sheath comprises pulling back the moveable sheath to expose a portion of the replacement heart valve device from the moveable sheath. 
     
     
         37 . The method of  claim 34 , wherein the guiding step is done transluminally. 
     
     
         38 . The method of  claim 37 , wherein the guiding step is done transluminally over the guide wire. 
     
     
         39 . The method of  claim 34 , further comprising using an introducer for receiving the moveable sheath. 
     
     
         40 . The method of  claim 34 , wherein the stent member is self-expanding. 
     
     
         41 . The method of  claim 40 , wherein the stent member comprises nitinol. 
     
     
         42 . The method of  claim 34 , wherein constant high definition imaging is conducted after the providing step. 
     
     
         43 . The method of  claim 42 , wherein the constant high definition imaging includes using intravascular ultrasound. 
     
     
         44 . The method of  claim 42 , wherein the constant high definition imaging includes using an angioscope. 
     
     
         45 . The method of  claim 34 , wherein after the replacement heart valve device is fully expanded, monitoring of the replacement heart valve device is performed. 
     
     
         46 . The method of  claim 45 , wherein the monitoring comprises echocardiography. 
     
     
         47 . The method of  claim 45 , wherein the monitoring comprises angiography.