Integrated valve assembly and method of delivering and deploying an integrated valve assembly

Abstract

An integrated valve prosthesis includes an anchor stent, a tether component, and a valve component. The anchor stent includes a self-expanding tubular frame member configured to be deployed in the annulus of an aortic valve or the aorta. The valve component includes a valve frame and a prosthetic valve coupled to the valve frame, and is configured to be deployed within the anchor stent. The tether component includes a first end coupled to the anchor stent and a second end coupled to the valve frame. In the delivery configuration, the tether component extends in a first direction from the anchor stent to the valve component, and in the deployed configuration, the tether component extends in a second direction from the anchor stent to the valve component. The second direction is generally opposite the first direction. The tether component may set the location of the valve component relative to the anchor stent.

What is claimed is: 
     
         1 . An integrated valve assembly having a radially compressed delivery configuration and a radially expanded deployed configuration, the valve prosthesis comprising:
 an anchor stent; and   a valve component including a valve frame and a prosthetic valve coupled to the valve frame; and   a tether component having a first end coupled to the anchor stent and a second end coupled to the valve component, wherein in the delivery configuration the tether component extends in a first direction from the anchor stent to the valve component, and in the deployed configuration the tether component extends in a second direction from the anchor stent to the valve component, wherein the second direction is generally opposite the first direction.   
     
     
         2 . The integrated valve assembly of  claim 1 , wherein the anchor stent is configured to be deployed within the annulus of an aortic valve. 
     
     
         3 . The integrated valve assembly of  claim 2 , wherein in the radially expanded deployed configuration, a proximal portion of the valve frame is deployed within the anchor stent. 
     
     
         4 . The integrated valve assembly of  claim 2 , wherein the tether component is configured such that in the deployed configuration the tether component is taut to set the location of the valve component within the anchor stent. 
     
     
         5 . The integrated valve assembly of  claim 2 , wherein the tether component comprises a plurality of tethers, and wherein each tether is an elongate element. 
     
     
         6 . The integrated valve assembly of  claim 5 , further comprising a tubular skirt coupled to an inner surface or outer surface of the tethers. 
     
     
         7 . The integrated valve assembly of  claim 2 , wherein the tether component comprises a tubular skirt. 
     
     
         8 . The integrated valve assembly of  claim 7 , wherein in the deployed configuration, a portion of the tubular skirt is configured to extend proximal of the anchor stent. 
     
     
         9 . The integrated valve assembly of  claim 8 , wherein in the deployed configuration, the portion of the tubular skirt extending proximal of the anchor stent is configured to extend radially outward to seal against tissue of the heart. 
     
     
         10 . The integrated valve assembly of  claim 1 , wherein the anchor stent is configured to be deployed in the aorta, and wherein a proximal portion of the valve frame is configured to be deployed in the annulus of the aortic valve. 
     
     
         11 . The integrated valve assembly of  claim 10 , wherein the tether component is configured such that in the deployed configuration the tether is taut to set the location of the valve component within the annulus of the aortic valve. 
     
     
         12 . The integrated valve assembly of  claim 11 , wherein the tether component comprises a plurality of tethers, further comprising a tubular skirt coupling the tethers to the valve component. 
     
     
         13 . The integrated valve assembly of  claim 12 , wherein in the deployed configuration, the tubular skirt is configured to be disposed between the valve frame and the annulus of the aortic valve. 
     
     
         14 . The integrated valve assembly of  claim 11 , wherein the anchor stent further comprises a proximal arm component, extending from a proximal end of the anchor stent, the proximal arm component configured to be deployed in the sinuses of the aortic valve. 
     
     
         15 . The integrated valve assembly of  claim 14 , wherein the proximal arm component comprises three proximal arms with each proximal arm configured to be deployed in one of the three aortic sinuses. 
     
     
         16 . The integrated valve assembly of  claim 14 , wherein the proximal arm component comprises a plurality of proximal arms and each proximal arm comprises a wire loop with a first end of the wire coupled to the proximal end of the anchor stent, the wire extending proximally from the first end and bending back distally to a second end of the wire coupled to the proximal end of the anchor stent spaced from the first end. 
     
     
         17 . The integrated valve assembly of  claim 16 , wherein the proximal arm component comprises three proximal arms with each proximal arm configured to be deployed in one of the three aortic sinuses. 
     
     
         18 . A method of implanting an integrated valve assembly at a location of a native valve comprising the steps of:
 advancing the integrated valve assembly in a radially compressed delivery configuration to the location of the native valve, wherein the integrated valve assembly comprises an anchor stent, a valve component including a valve frame and a prosthetic valve, and a tether component having a first end coupled to the anchor stent and a second end coupled to the valve component, wherein in the radially compressed delivery configuration the tether component extends in a first direction from the anchor stent to the valve component;   deploying the anchor stent from the radially compressed configuration to a radially expanded configuration at a location within an annulus of the native valve;   advancing the valve component in the delivery configuration in a second direction opposite the first direction through at least a portion of the anchor stent such that the tether component extends in the second direction from the anchor stent to the valve component; and   deploying the valve component such that the valve frame expands from the radially compressed delivery configuration to a radially expanded configuration with a proximal portion of the valve frame engaging an inner surface of the anchor stent.   
     
     
         19 . The method of  claim 18 , wherein the step of advancing the valve component in the delivery configuration through at least a portion of the anchor stent comprises advancing the valve component until the tether component becomes taught such that a length of the tether sets a location for the deployed valve component. 
     
     
         20 . The method of  claim 18 , wherein the tether component comprises a plurality of tethers. 
     
     
         21 . The method of  claim 18 , wherein the tether component comprises a tubular skirt, the tubular skirt being configured such that the step of advancing the valve component disposes the tubular skirt between the anchor stent and the valve frame. 
     
     
         22 . The method of  claim 21 , wherein the step of advancing the valve component causes the tubular skirt to fold such that a portion of the skirt extends proximal of the anchor stent and wherein the step of deploying the valve component causes the portion of the tubular skirt extending proximal of the anchor stent to extend radially outward to seal the skirt against tissue of the heart. 
     
     
         23 . A method of implanting an integrated valve assembly at a location of a native valve comprising the steps of:
 advancing the integrated valve assembly in a radially compressed configuration into the aorta, wherein the integrated valve assembly comprises an anchor stent, a valve component including a valve frame and a prosthetic valve, and a tether component having a first end coupled to the anchor stent and a second end coupled to the valve component, wherein in the delivery configuration the tether component extends in a first direction from the anchor stent to the valve component;   deploying the anchor stent from the radially compressed configuration to a radially expanded configuration at a location within the aorta;   advancing the valve component in the delivery configuration in a second direction opposite the first direction through the anchor stent until the tether component becomes taut;   deploying the valve component such that the valve frame expands from the radially compressed configuration to a radially expanded deployed configuration with a first portion of the valve frame engaging the aortic valve.   
     
     
         24 . The method of  claim 23 , wherein the tether component comprises a plurality of tethers. 
     
     
         25 . The method of  claim 23 , wherein a length of the tether component is configured such that the step advancing the valve component until the tether becomes taut causes at least a portion of the valve component to be disposed within an annulus of the aortic valve. 
     
     
         26 . The method of  claim 24 , wherein the tether component comprises a tubular skirt disposed adjacent the valve component such that the step of advancing the valve component and deploying the anchor component disposes the tubular skirt between the valve component and the annulus of the aortic valve. 
     
     
         27 . The method of  claim 23 , wherein the anchor stent further comprises a proximal arm component extending from a proximal end of the anchor stent, wherein the step of deploying the anchor stent comprises deploying the proximal arm component in a sinus of the aortic valve. 
     
     
         28 . The method of  claim 27 , wherein the proximal arm component comprises a plurality of proximal arms and the step of deploying the anchor stent comprises deploying each proximal arm in one of the three aortic sinuses.