Transcatheter valve prosthesis and a concurrently delivered sealing component
A method of preventing paravalvular leakage includes concurrent delivery of a heart valve prosthesis and an annular sealing component. During delivery, the sealing component is moved from a first position to a second position of the heart valve prosthesis which is longitudinally spaced apart from the first position of the heart valve prosthesis. The sealing component is secured around the heart valve prosthesis at the second position by a contoured outer surface of the heart valve prosthesis. The sealing component may be a flexible ring or may be a cylindrical flexible sleeve having a plurality of ribs longitudinally extending over the cylindrical sleeve. The ribs operate to deploy the sealing component such that at least a portion of the cylindrical sleeve buckles outwardly away from the outer surface of the heart valve prosthesis.
1 . A method of preventing paravalvular leakage, the method comprising the steps of:
percutaneously advancing a catheter to a target site, wherein the catheter includes a heart valve prosthesis and an annular sealing component, wherein the sealing component is not coupled to the valve prosthesis and is positioned around an outer surface of the heart valve prosthesis at a first position on the heart valve prosthesis;
deploying at least a portion of the heart valve prosthesis against native valve tissue at the target site; and
moving the sealing component over a distal portion of a shaft of the catheter to a second position on the heart valve prosthesis which is longitudinally spaced apart from the first position of the heart valve prosthesis, wherein at least a portion of the heart valve prosthesis is radially compressed within the distal portion of the shaft during the step of moving the sealing component, wherein the sealing component is secured around the heart valve prosthesis at the second position by a contoured outer surface of the heart valve prosthesis and the sealing component prevents gaps between the valve prosthesis and the native valve tissue to prevent paravalvular leakage.
2 . The method of claim 1 , wherein the heart valve prosthesis includes a self-expanding tubular stent component including a first portion and a second portion, a prosthetic valve component disposed within and secured to the stent component, and at least one self-expanding support arm coupled to the first portion of the stent component, wherein a deployed diameter of the first portion is less than a deployed diameter of the second portion.
3 . The method of claim 2 , wherein the first position of the sealing component on the heart valve prosthesis occurs within the second portion of the heart valve prosthesis and the second position of the sealing component on the heart valve prosthesis occurs within the first portion of the heart valve prosthesis, between the second portion of the heart valve prosthesis and the at least one self-expanding support arm.
4 . The method of claim 3 , wherein the step of deploying at least a portion of the heart valve prosthesis includes radially expanding the at least one support arm and the step of moving the sealing component includes pushing the sealing component over the stent component from the first position to the second position until the sealing component abuts against the at least one expanded support arm.
5 . The method of claim 4 , further comprising the step of radially expanding the stent component after the sealing component is positioned against the expanded at least one support arm.
6 . The method of claim 4 , wherein the sealing component is a conformable polymer ring.
7 . The method of claim 1 , wherein the step of deploying at least a portion of the heart valve prosthesis against native valve tissue at the target site includes deploying a first portion of the heart valve prosthesis and at least one self-expanding support arm coupled to the first portion, wherein a deployed diameter of the first portion is less than a deployed diameter of a second portion of the heart valve prosthesis, and
wherein the second portion of the heart valve prosthesis is radially compressed within the distal portion of the shaft during the step of moving the sealing component.
8 . The method of claim 7 , wherein the step of moving the sealing component includes pushing the sealing component over the second portion of the heart valve prosthesis until the sealing component is disposed around the first portion of the heart valve prosthesis and abuts against the at least one self-expanding support arm.
9 . The method of claim 8 , further comprising the step of deploying the second portion of the heart valve prosthesis after the step of moving the sealing component.
10 . A method of preventing paravalvular leakage, the method comprising the steps of:
percutaneously advancing a delivery system to a target site, wherein a distal portion of the delivery system includes a heart valve prosthesis and an annular sealing component;
deploying at least a portion of the heart valve prosthesis against native valve tissue at the target site; and
moving at least a portion of the sealing component over a distal portion of a shaft of the delivery system from a first position relative to the heart valve prosthesis to a second position relative to the heart valve prosthesis to position the sealing component around an end of the heart valve prosthesis, the second position being longitudinally spaced apart from the first position, wherein at least a portion of the heart valve prosthesis is radially compressed within the distal portion of the shaft during the step of moving the sealing component, wherein the sealing component at the second position prevents gaps between the valve prosthesis and the native valve tissue to prevent paravalvular leakage.
11 . The method of claim 10 , wherein the heart valve prosthesis includes a self-expanding tubular stent component including a first portion and a second portion, a prosthetic valve component disposed within and secured to the stent component, and at least one self-expanding support arm coupled to the first portion of the stent component, wherein a deployed diameter of the first portion is less than a deployed diameter of the second portion.
12 . The method of claim 11 , wherein the sealing component is disposed around the second portion of the heart valve prosthesis when in the first position and the sealing component is disposed around the first portion of the heart valve prosthesis when in the second position, adjacent to the at least one self-expanding support arm.
13 . The method of claim 12 , wherein the step of deploying at least a portion of the heart valve prosthesis includes radially expanding the at least one support arm and the step of moving the sealing component includes pushing the sealing component over the stent component from the first position to the second position until the sealing component abuts against the at least one expanded support arm.
14 . The method of claim 13 , further comprising the step of radially expanding the stent component after the sealing component is positioned in the second position.
15 . The method of claim 10 , wherein the sealing component is a conformable polymer ring.
16 . The method of claim 10 , wherein the sealing component is secured around the heart valve prosthesis at the second position by a contoured outer surface of the heart valve prosthesis.
17 . The method of claim 10 , wherein the sealing component is coupled to a distal end of an outer shaft of the delivery system by at least one suture, and the method further includes the step of severing the at least one suture after the step of moving the sealing component.
18 . The method of claim 10 , wherein the step of deploying at least a portion of the heart valve prosthesis against native valve tissue at the target site includes deploying a first portion of the heart valve prosthesis and at least one self-expanding support arm coupled to the first portion, wherein a deployed diameter of the first portion is less than a deployed diameter of a second portion of the heart valve prosthesis, and
wherein the second portion of the heart valve prosthesis is radially compressed within the distal portion of the shaft during the step of moving the sealing component.
19 . The method of claim 18 , wherein the step of moving the sealing component includes pushing the sealing component over the second portion of the heart valve prosthesis until the sealing component is disposed around the first portion of the heart valve prosthesis and abuts against the at least one self-expanding support arm.
20 . The method of claim 19 , further comprising the step of deploying the second portion of the heart valve prosthesis after the step of moving the sealing component.