Heart valve holder for constricting the valve commissures and methods of use
First Claim
1. A holder for a tissue-type prosthetic mitral heart valve attachable to a surgical delivery handle, the heart valve having an inflow end and an outflow end and a flow axis therebetween, the valve including an annular suture ring at the inflow end and radially flexible commissure posts circumferentially-spaced around the outflow end that support occluding tissue surfaces of the valve, comprising:
- a commissure post constriction mechanism releasably attached to the sewing ring at the inflow end of the valve, the mechanism adapted to constrict the valve commissure posts radially inward from a relaxed position to a constricted position when actuated by the delivery handle, and a retaining mechanism that retains the commissure post constriction mechanism in the constricted position after the delivery handle is removed.
1 Assignment
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Accused Products
Abstract
An improved holder, system and method for implanting a tissue-type prosthetic heart mitral valve that constricts the commissure posts of the valve and allows the user to detach the handle of the holder prior to withdrawing the holder itself. The ability to remove the handle allows a surgeon greater access to suturing the prosthetic valve to the mitral annulus. The holder may include two relatively movable plates, one of which attaches to the valve sewing on the inflow end of the valve ring and the other which attaches via sutures to the valve commissures on the outflow end. Separation of the plates places the sutures in tension and constricts the commissures. An adjusting member or adapter is interposed between the handle and holder to enable separation of the two plates and removal of the handle. The adjusting member or adapter may be packaged with the valve and holder combination, or may be sold as a separate unit, possibly with the handle, so that prior art holders can be retrofit.
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Citations
27 Claims
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1. A holder for a tissue-type prosthetic mitral heart valve attachable to a surgical delivery handle, the heart valve having an inflow end and an outflow end and a flow axis therebetween, the valve including an annular suture ring at the inflow end and radially flexible commissure posts circumferentially-spaced around the outflow end that support occluding tissue surfaces of the valve, comprising:
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a commissure post constriction mechanism releasably attached to the sewing ring at the inflow end of the valve, the mechanism adapted to constrict the valve commissure posts radially inward from a relaxed position to a constricted position when actuated by the delivery handle, and a retaining mechanism that retains the commissure post constriction mechanism in the constricted position after the delivery handle is removed. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
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13. A method for retrofitting a holder for a tissue-type prosthetic mitral heart valve attachable to a surgical delivery handle, the heart valve having an inflow end and an outflow end and a flow axis therebetween, the valve including an annular suture ring at the inflow end and radially flexible commissure posts circumferentially-spaced around the outflow end that support occluding tissue surfaces of the valve, the holder having a commissure post constriction mechanism releasably attached to the sewing ring at the inflow end of the valve, the mechanism adapted to constrict the valve commissure posts radially inward from a relaxed position to a constricted position when actuated by the delivery handle, the method including:
providing a retaining mechanism that retains the commissure post constriction mechanism in the constricted position after the delivery handle is removed. - View Dependent Claims (14, 15, 16, 17)
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18. A kit of storage and handling clips and heart valve holders for different diameter tissue-type prosthetic mitral heart valves, the heart valves each having an inflow end and an outflow end and a flow axis therebetween, each valve including an annular suture ring at the inflow end and radially flexible commissure posts circumferentially-spaced around the outflow end that support occluding tissue surfaces of the valve, the kit comprising:
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a set of holders each adapted to attach to the sewing ring at the inflow end of a valve and having a generally planar portion including a plurality of tangs radiating from a central body to cover a portion of the suture ring, the tangs being radially dimensioned to correspond to the diameter of the sewing ring; and
each holder including a plurality of peripheral notches in the planar portion; and
a plurality of identical storage and handling clips each having a plurality of fingers for engaging the peripheral notches in any one of the holders. - View Dependent Claims (19, 20, 21)
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22. A method for replacing a heart valve, comprising the steps of:
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providing a prosthetic tissue-type heart valve having an inflow end and an outflow end and a flow axis therebetween and including a suture ring affixed to a stent having commissure posts circumferentially-spaced about the flow axis for supporting occluding surfaces of the valve, the commissure posts being cantilevered generally in the outflow direction;
affixing a holder to the inflow end of the valve;
attaching a handle to the holder and simultaneously constricting the commissure posts of the valve;
inserting the valve to the target annulus of the native heart valve using the handle;
removing the handle while maintaining the commissure posts constricted;
securing the valve to the annulus; and
detaching the holder from the valve. - View Dependent Claims (23, 24, 25, 26, 27)
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Specification