Replacement heart valves, delivery devices and methods
AssigneeEdwards Lifesciences CardiAQ LLC
InventorsArshad Quadri, J. Brent Ratz
Life of this patent
Estimating the term…
Abstract
A replacement heart valve and method of treating valve insufficiency includes an expandable frame configured to engage a native valve annulus. A valve body is coupled to the frame. The valve body can include a leaflet portion and possibly a skirt portion. A portion of the frame has a foreshortening portion configured to longitudinally expand when urged to a radially compacted state and longitudinally contract when urged to a radially expanded state. In one embodiment the valve skirt is attached to the frame so that it can adapt to changes in the length of the frame. A delivery device in some embodiments can use one or more coverings, such as sheaths, to controllably release the replacement heart valve at a native heart valve.
Claims20
A method of delivering a replacement valve to a native mitral valve or tricuspid valve and securing the replacement valve relative to a native mitral valve annulus or tricuspid valve annulus, the native mitral valve annulus or tricuspid valve annulus supporting native leaflets, the method comprising:
- delivering a replacement valve mounted on a delivery system to the native mitral valve annulus or tricuspid valve annulus while the replacement valve is in a radially compacted state, the replacement valve having an open inflow end and an open outflow end, the replacement valve comprising a radially expandable frame and a plurality of anchors having tips extending from the frame at or generally near the outflow end of the replacement valve, wherein the replacement valve both increases and decreases in diameter between the open outflow end and the open inflow end when in a fully expanded state,
- wherein the delivery system comprises an outer sheath, an outer support tube, an inner tube, and an inner retention ring,
- wherein the inner retention ring is positioned on the inner tube,
- wherein the outer support tube concentrically encircles the inner tube and is sized to be slidable over the inner tube and the inner retention ring,
- wherein the outer sheath is disposed so as to be slidable over the outer support tube,
- wherein the inner retention ring is configured to engage tabs on the open inflow end of the replacement valve, and
- wherein the replacement valve is positioned within the delivery system in an orientation such that the open outflow end is positioned closer to a distal end of the outer sheath so that the open outflow end leads the open inflow end upon delivery;
- positioning the replacement valve so that the tips are on a ventricular side of the native leaflets beyond a location where chordae tendineae connect to free ends of the native leaflets;
- releasing at least a distal portion of the replacement valve comprising the open outflow end from the delivery system by retracting the outer sheath to thereby expand the plurality of anchors radially outwardly while the open inflow end of the replacement valve remains constrained by the outer support tube;
- extending the plurality of anchors between at least some of the chordae tendineae;
- and
- engaging the tips with tissue on the ventricular side of the native mitral valve annulus or tricuspid valve annulus;
- wherein, after engaging the tips, the outer support tube is retracted to deploy the open inflow end and the replacement valve is positioned so that a portion of the radially expandable frame, having a larger diameter than the open inflow end of the replacement valve, is positioned within the native mitral valve annulus or tricuspid valve annulus.
A method of delivering a replacement valve to a native mitral valve and securing the replacement valve relative to a native mitral valve annulus, the native mitral valve annulus supporting native leaflets, the method comprising:
- delivering a replacement valve mounted on a delivery system to the native mitral valve annulus while the replacement valve is in a radially compacted state, the replacement valve having an open inflow end and an open outflow end, the replacement valve comprising a radially expandable frame and a plurality of anchors having tips extending from the frame at or generally near the outflow end of the replacement valve, wherein the replacement valve both increases and decreases in diameter between the open outflow end and the open inflow end and wherein at least a proximal-most portion of the open inflow end is generally cylindrical when the replacement valve is in a fully expanded state;
- positioning the replacement valve so that the tips are on a ventricular side of the native leaflets beyond a location where chordae tendineae connect to free ends of the native leaflets;
- releasing at least a portion of the replacement valve from the delivery system to thereby expand the plurality of anchors radially outwardly;
- extending the plurality of anchors between at least some of the chordae tendineae;
- and
- engaging the tips with tissue on the ventricular side of the native mitral valve annulus;
- wherein, after engaging the tips, the replacement valve is positioned so that a portion of the radially expandable frame, having a larger diameter than the open inflow end of the replacement valve, is positioned within the native mitral valve annulus;
- and
- wherein the frame at or generally near the open outflow end of the replacement valve comprises a plurality of cells.
A method of delivering a replacement valve to a native mitral valve and securing the replacement valve relative to the native mitral valve annulus, the native mitral valve annulus supporting native leaflets, the method comprising:
- delivering a replacement valve mounted on a delivery system to the native mitral valve annulus while the replacement valve is in a radially compacted state, the replacement valve having an open inflow end and an open outflow end, the replacement valve comprising a radially expandable frame and a plurality of anchors having tips extending from the frame at or generally near the outflow end of the replacement valve, wherein the replacement valve both increases and decreases in diameter between the open outflow end and the open inflow end;
- positioning the replacement valve so that the tips are on a ventricular side of the native leaflets beyond a location where chordae tendineae connect to free ends of the native leaflets;
- releasing at least a portion of the replacement valve from the delivery system to thereby expand the plurality of anchors radially outwardly;
- extending the plurality of anchors between at least some of the chordae tendineae;
- and
- engaging the tips with tissue on the ventricular side of the native mitral valve annulus;
- wherein, after engaging the tips, the replacement valve is positioned so that a portion of the radially expandable frame, having a larger diameter than the open inflow end of the replacement valve, is positioned within the native mitral valve annulus;
- wherein after the at least a portion of the replacement valve is released from the delivery system, each of the plurality of anchors initially extends radially inwards and then radially outwards from the frame towards the tips.
Dependencies are inferred from the claim text.