Methods and apparatuses for deploying minimally-invasive heart valves

Abstract

An assembly includes an expandable prosthetic heart valve, a catheter shaft, and a stabilization device. The expandable prosthetic heart valve has a valve body and a plurality of leaflets coupled to the valve body. The catheter shaft has a proximal end portion and a distal end portion. The prosthetic heart valve is coupled to the distal end portion of the catheter shaft. The stabilization device is coupled to the catheter shaft adjacent the prosthetic heart valve and is movable between a contracted configuration and an expanded configuration. In the expanded configuration, the stabilization device is configured to contact surrounding tissue adjacent a site of implantation to stabilize the catheter shaft relative to the site of implantation while the prosthetic heart valve is radially expanded from a radially-compressed state to a radially-expanded state at the site of implantation.

We claim: 
     
         1 . An assembly, comprising:
 an expandable prosthetic heart valve having a valve body and a plurality of leaflets coupled to the valve body;   a catheter shaft having a proximal end portion and a distal end portion, wherein the prosthetic heart valve is coupled to the distal end portion of the catheter shaft; and   a stabilization device coupled to the catheter shaft adjacent the prosthetic heart valve, wherein the stabilization device is movable between a contracted configuration and an expanded configuration, and wherein in the expanded configuration, the stabilization device is configured to contact surrounding tissue adjacent a site of implantation to stabilize the catheter shaft relative to the site of implantation while the prosthetic heart valve is radially expanded from a radially-compressed state to a radially-expanded state at the site of implantation.   
     
     
         2 . The assembly of  claim 1 , wherein the stabilization device is an inflatable balloon. 
     
     
         3 . The assembly of  claim 1 , wherein the stabilization device is sized to contact a native aorta when the stabilization device is in the expanded configuration. 
     
     
         4 . The assembly of  claim 1 , wherein the stabilization device is shaped to permit blood to flow past the stabilization device when the stabilization device is in the expanded configuration. 
     
     
         5 . The assembly of  claim 4 , wherein the stabilization device is lobed-shaped when the stabilization device is in the expanded configuration. 
     
     
         6 . The assembly of  claim 4 , wherein the stabilization device is star-shaped when the stabilization device is in the expanded configuration. 
     
     
         7 . The assembly of  claim 1 , wherein the stabilization device comprises a mechanically-expanding structure having struts. 
     
     
         8 . The assembly of  claim 1 , wherein the stabilization device comprises a mechanically-expanding structure having a wire matrix. 
     
     
         9 . The assembly of  claim 1 , further comprising a deployment mechanism coupled to the distal end portion of the catheter shaft, wherein the deployment mechanism is coupled to the prosthetic heart valve and configured for regulating expansion of the prosthetic heart valve 
     
     
         10 . The assembly of  claim 9 , wherein the stabilization device is coupled to the catheter shaft proximal to the deployment mechanism. 
     
     
         11 . An assembly, comprising:
 an expandable prosthetic heart valve having a valve body and a plurality of leaflets coupled to the valve body;   a catheter shaft having a proximal end portion and a distal end portion, wherein the prosthetic heart valve is coupled to the distal end portion of the catheter shaft; and   an inflatable balloon coupled to the catheter shaft adjacent the prosthetic heart valve, wherein the balloon is movable between a contracted configuration and an expanded configuration, and wherein in the expanded configuration, the balloon is configured to contact surrounding tissue adjacent a native heart valve to stabilize the catheter shaft relative to the native heart valve while the prosthetic heart valve is radially expanded from a radially-compressed state to a radially-expanded state in the native heart valve.   
     
     
         12 . The assembly of  claim 11 , wherein the native heart valve is a native aortic valve, and wherein the balloon device is sized to contact a native aorta when the balloon is in the expanded configuration. 
     
     
         13 . The assembly of  claim 11 , wherein the native heart valve is a mitral valve, and wherein the balloon device is sized to contact a wall of the heart when the balloon is in the expanded configuration. 
     
     
         14 . The assembly of  claim 11 , wherein the balloon is shaped to permit blood to flow past the balloon when the balloon is in the expanded configuration. 
     
     
         15 . The assembly of  claim 14 , wherein the balloon is lobed-shaped when the balloon in the expanded configuration. 
     
     
         16 . An assembly, comprising:
 an expandable prosthetic heart valve having a valve body and a plurality of leaflets coupled to the valve body;   a catheter shaft having a proximal end portion and a distal end portion, wherein the prosthetic heart valve is coupled to the distal end portion of the catheter shaft; and   a mechanically-expanding structure coupled to the catheter shaft adjacent the prosthetic heart valve, wherein the mechanically-expanding structure has a plurality of struts that are movable between a contracted configuration and an expanded configuration, and wherein in the expanded configuration, the struts are configured to contact surrounding tissue adjacent a native heart valve to stabilize the catheter shaft relative to the native heart valve while the prosthetic heart valve is radially expanded from a radially-compressed state to a radially-expanded state in the native heart valve.   
     
     
         17 . The assembly of  claim 16 , wherein the native heart valve is a native aortic valve, and wherein the struts of the mechanically-expanding structure are sized to contact a native aorta when the struts are in the expanded configuration. 
     
     
         18 . The assembly of  claim 16 , wherein the native heart valve is a mitral valve, and wherein the struts of the mechanically-expanding structure are sized to contact a wall of the heart when the struts are in the expanded configuration. 
     
     
         19 . The assembly of  claim 16 , wherein the struts of the mechanically-expanding structure are shaped to permit blood to flow past the struts when the struts are in the expanded configuration. 
     
     
         20 . The assembly of  claim 16 , further comprising a deployment mechanism coupled to the distal end portion of the catheter shaft, wherein the deployment mechanism is coupled to the prosthetic heart valve and configured for regulating expansion of the prosthetic heart valve, and wherein the mechanically-expanding structure is coupled to the catheter shaft proximal to the deployment mechanism.