Methods and devices for repairing and/or preventing paravalvular leakage post-implantation of a valve prosthesis
First Claim
1. A method of preventing and/or repairing paravalvular leakage, the method comprising the steps of:
- advancing a catheter to a previously implanted valve prosthesis, wherein the catheter is configured to deliver an injectable sealing material;
injecting the sealing material around an outer surface of the implanted valve prosthesis via the catheter by extending a plurality of needles of the catheter through graft material of the implanted valve prosthesis and delivering the sealing material through the plurality of needles; and
allowing the sealing material to expand and solidify in situ to form an annular sealing element that extends between the outer surface of the implanted valve prosthesis and native valve tissue to close and/or prevent gaps between the implanted valve prosthesis and native valve tissue to repair and/or prevent paravalvular leakage.
1 Assignment
0 Petitions
Accused Products
Abstract
Devices and methods for delivering a sealing element post-implantation of valve prosthesis that functions to occlude or fill gaps present between the valve prosthesis and the native valve tissue, thereby reducing, minimizing, or eliminating leaks there through. In a first method, an injectable material is placed within a native valve sinus to form a sealing element that presses native valve leaflets against an outer surface of a heart valve prosthesis. In a second method, an injectable sealing material or a preformed annular sealing component is positioned between the outer surface or perimeter of a heart valve prosthesis and native heart valve tissue. In a third method, a preformed sealing element or component is placed within a heart valve prosthesis to press the prosthesis against native valve tissue.
42 Citations
20 Claims
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1. A method of preventing and/or repairing paravalvular leakage, the method comprising the steps of:
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advancing a catheter to a previously implanted valve prosthesis, wherein the catheter is configured to deliver an injectable sealing material; injecting the sealing material around an outer surface of the implanted valve prosthesis via the catheter by extending a plurality of needles of the catheter through graft material of the implanted valve prosthesis and delivering the sealing material through the plurality of needles; and allowing the sealing material to expand and solidify in situ to form an annular sealing element that extends between the outer surface of the implanted valve prosthesis and native valve tissue to close and/or prevent gaps between the implanted valve prosthesis and native valve tissue to repair and/or prevent paravalvular leakage. - View Dependent Claims (2, 3, 10, 11, 12, 13)
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4. A method of preventing and/or repairing paravalvular leakage, the method comprising the steps of:
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advancing a catheter to a previously implanted valve prosthesis, wherein the catheter is configured to deliver an injectable sealing material; injecting the sealing material around an outer surface of the implanted valve prosthesis via the catheter by positioning an umbrella-like delivery component of the catheter around an end of the implanted valve prosthesis and delivering the sealing material through the umbrella-like delivery component; and allowing the sealing material to expand and solidify in situ to form an annular sealing element that extends between the outer surface of the implanted valve prosthesis and native valve tissue to close and/or prevent gaps between the implanted valve prosthesis and native valve tissue to repair and/or prevent paravalvular leakage. - View Dependent Claims (14, 15)
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5. A method of preventing and/or repairing paravalvular leakage, the method comprising the steps of:
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advancing a catheter to a previously implanted valve prosthesis, wherein the catheter is configured to deliver an injectable sealing material; injecting the sealing material around an outer surface of the implanted valve prosthesis via the catheter; temporarily crimping a first end of the implanted valve prosthesis prior to the step of injecting the sealing material around an outer surface of the implanted valve prosthesis via the catheter; and allowing the sealing material to expand and solidify in situ to form an annular sealing element that extends between the outer surface of the implanted valve prosthesis and native valve tissue to close and/or prevent gaps between the implanted valve prosthesis and native valve tissue to repair and/or prevent paravalvular leakage. - View Dependent Claims (16, 17)
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6. A method of preventing and/or repairing paravalvular leakage, the method comprising the steps of:
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advancing a catheter to a previously implanted valve prosthesis, wherein the catheter includes an annular sealing component mounted thereon; and positioning the annular sealing component onto the implanted valve prosthesis, wherein the annular sealing component is positioned within the implanted valve prosthesis to over-expand and press at least a portion of the implanted valve prosthesis against native valve tissue and wherein the annular sealing component closes and/or prevents gaps between the implanted valve prosthesis and native valve tissue to repair and/or prevent paravalvular leakage. - View Dependent Claims (7, 8, 9, 18, 19, 20)
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Specification