Method and apparatus for replacing a prosthetic valve

Abstract

In one aspect, the present disclosure concerns a percutaneously delivered adapter stent that is deployed within a previously implanted prosthetic valve and serves as an anchor or platform for implanting a percutaneously delivered replacement valve within the previously implanted valve. The adapter stent can be delivered to the implantation site via the patient's vasculature and positioned within the previously implanted valve. The stent can then be deployed to cause the stent to expand and become anchored to the inner surface of the previously implanted valve. Subsequently, the replacement valve can be positioned within the adapter stent and deployed to cause the replacement valve to expand and become anchored to the adapter stent. The adapter stent and the replacement valve can be mounted on the same catheter for delivery to the implantation site.

1 . A method of percutaneously implanting a replacement prosthetic valve at a site occupied by a previously implanted prosthetic valve, the method comprising:
 positioning a stent within the previously implanted valve;   deploying the stent to cause the stent to become anchored to the previously implanted valve;   positioning the replacement valve within the deployed stent; and   deploying the replacement valve to cause the replacement valve to become anchored to the stent.   
     
     
         2 . The method of  claim 1  wherein the stent and the replacement valve are mounted on a common delivery catheter, which is used to position stent and the replacement valve at their respective deployment positions. 
     
     
         3 . The method of  claim 2  wherein:
 the stent is mounted on a first balloon of the catheter and the replacement valve is mounted on a second balloon of the catheter;   deploying the stent comprises inflating the first balloon to cause the stent to expand and engage the previously implanted valve; and   deploying the replacement valve comprises inflating the second balloon to cause the replacement valve to engage the stent.   
     
     
         4 . The method of  claim 2 , wherein:
 the stent is self-expandable and is retained in a radially compressed state on the catheter by a sheath; and   deploying the stent comprises withdrawing the sheath from the stent to allow the stent to expand and engage the previously implanted valve.   
     
     
         5 . The method of  claim 4 , wherein:
 the replacement valve is self-expandable and is retained in a radially compressed state on the catheter by the sheath; and   deploying the replacement valve comprises withdrawing the sheath from the replacement valve to allow it to expand and engage the stent.   
     
     
         6 . The method of  claim 1 , wherein:
 the stent has a length that is greater than the length of the previously implanted valve and enlarged opposite end portions that are greater in diameter than an intermediate portion of the stent when the stent is deployed; and   when the stent is deployed, the enlarged opposite end portions of the stent are positioned outside of the previously implanted valve to assist in retaining the deployed stent in place.   
     
     
         7 . The method of  claim 1 , the stent comprises an annular sealing member that creates a seal between the previously implanted valve and the replacement valve once deployed. 
     
     
         8 . The method of  claim 7 , wherein the sealing member comprises an elastomer. 
     
     
         9 . The method of  claim 8 , wherein the sealing member comprises sponge rubber. 
     
     
         10 . The method of  claim 1 , wherein the previously implanted valve is located in the aortic annulus of a patient and the stent and the replacement valve are delivered to the deployment site via the aorta. 
     
     
         11 . The method of  claim 1 , wherein the replacement valve comprises a frame and a valve member secured to the stent. 
     
     
         12 . A method of percutaneously implanting a replacement prosthetic valve in a patient at a site occupied by a previously implanted prosthetic valve, the method comprising:
 advancing a catheter carrying a stent through the patient's vasculature to position the stent within the previously implanted valve, the catheter also carrying the replacement valve;   deploying the stent to cause the stent to become anchored to the previously implanted valve;   re-positioning the catheter to position the replacement valve within the deployed stent; and   deploying the replacement valve to cause the replacement valve to become anchored to the stent.   
     
     
         13 . The method of  claim 12  wherein:
 the stent is mounted on a first balloon of the catheter and the replacement valve is mounted on a second balloon of the catheter;   deploying the stent comprises inflating the first balloon to cause the stent to expand and engage the previously implanted valve; and   deploying the replacement valve comprises inflating the second balloon to cause the replacement valve to engage the stent.   
     
     
         14 . The method of  claim 12 , wherein when the stent is deployed, opposite end portions of the stent extend outside opposite ends of the previously implanted valve and flare radially outwardly with respect to the opposite ends of the previously implanted valve. 
     
     
         15 . An assembly for percutaneous replacement of a previously implanted prosthetic valve without removal of the previously implanted valve, the assembly comprising:
 an adapter stent comprising a frame and an annular sealing member, the adapter stent being adapted to be deployed within the previously implanted valve; and   a percutaneous, replacement prosthetic valve comprising a frame and a flexible valve member, the valve being adapted to be deployed within the deployed stent such that the sealing member provides a seal between the previously implanted valve and the replacement valve.   
     
     
         16 . The assembly of  claim 15  wherein the sealing member comprises an elastomer. 
     
     
         17 . The assembly of  claim 15 , wherein the sealing member extends substantially the entire length of the frame of the adapter stent. 
     
     
         18 . The assembly of  claim 15 , wherein the sealing member is mounted on the outside of the frame of the adapter stent. 
     
     
         19 . The assembly of  claim 15 , wherein the sealing member is mounted on the inside of the frame of the adapter stent. 
     
     
         20 . The assembly of  claim 15 , wherein the frame of the adapter stent has an inlet end portion, an outlet end portion, and an intermediate portion extending between the end portions, the end portions being greater in diameter than the intermediate portion. 
     
     
         21 . The assembly of  claim 15 , wherein the frame of the adapter stent has a length of at least about 10 mm. 
     
     
         22 . The assembly of  claim 15 , wherein the frames of the replacement valve and the adapter stent are self-expandable. 
     
     
         23 . The assembly of  claim 15 , wherein the replacement valve is a prosthetic heart valve. 
     
     
         24 . An assembly for percutaneous replacement of a previously implanted prosthetic valve without removal of the previously implanted valve, comprising;
 a replacement prosthetic valve having a frame and a flexible valve member, the replacement prosthetic valve being radially expandable and collapsible; and   means for anchoring and sealing the replacement valve to the previously implanted valve, said means being separately deployable within the previously implanted valve prior to deploying the replacement valve within said means.   
     
     
         25 . The assembly of  claim 24 , wherein said means comprises an expandable frame and an annular sealing member secured to the frame.