MITRAL HEART VALVE HOLDER AND STORAGE SYSTEM
First Claim
1. A storage assembly for a flexible leaflet prosthetic heart valve that helps prevent suture looping, comprising:
- a heart valve having an inflow end and an outflow end and a flow axis therebetween, the valve including a plurality of generally axially-extending flexible commissure posts that end in tips circumferentially-spaced around the outflow end that support occluding flexible leaflets of the valve;
a valve holder that contacts the inflow end of the valve, the valve holder defining a central aperture;
a plurality of attachment sutures each having a first end tied to the valve holder, a middle section that extends from the first end in an outflow direction to one of the commissure post tips, extends to another one of the commissure post tips, and then extends in an inflow direction back to the valve holder, and a second end tied to the valve holder, wherein the middle section crosses the flow axis of the valve between the commissure post tips;
an adapter shaped to conform to an inflow side of the valve holder and attached thereto, the adapter defining a central aperture generally aligned with the valve holder central aperture and having a bridge across the aperture with a threaded nut centered thereon; and
a commissure constriction rod arranged to slide longitudinally through the valve holder aperture and adapter aperture, the rod having a closed bottom end toward the outflow direction and an open top end toward the inflow direction surrounded by a rim larger than the aperture of the valve holder but smaller than the aperture of the adapter, wherein a male threaded member may be screwed through the threaded nut of the adapter until it contacts the closed bottom end of the rod and forces the rod in an outflow direction from an undeployed position into contact with the middle sections of the attachment sutures that cross the flow axis, the rod being movable farther in the outflow direction to a deployed position which places the attachment sutures in tension and accordingly pulls the commissure post tips inward.
1 Assignment
0 Petitions
Accused Products
Abstract
An improved holder and storage system for a tissue-type prosthetic mitral heart valve that constricts the commissure posts of the valve and prevents suture looping. A rod axially movable relative to the holder tensions lengths of attachment sutures that extend between the commissure post tips to create a tent and flex the tips inward, thus helping to prevent looping of any of an array of pre-implanted sutures around the leading tips during delivery of the valve. The holder has a safety mechanism that prevents valve delivery before the rod is deployed. One embodiment automatically deploys the rod upon opening a storage jar. One embodiment permits a delivery handle to directly deploy the rod, while another uses a separate worm screw and coupling. A holder clip that attaches to a packaging sleeve may be formed of flexible members meshed together from which the heart valve and holder are easily pulled free to eliminate a step of decoupling the clip from the sleeve.
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Citations
22 Claims
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1. A storage assembly for a flexible leaflet prosthetic heart valve that helps prevent suture looping, comprising:
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a heart valve having an inflow end and an outflow end and a flow axis therebetween, the valve including a plurality of generally axially-extending flexible commissure posts that end in tips circumferentially-spaced around the outflow end that support occluding flexible leaflets of the valve; a valve holder that contacts the inflow end of the valve, the valve holder defining a central aperture; a plurality of attachment sutures each having a first end tied to the valve holder, a middle section that extends from the first end in an outflow direction to one of the commissure post tips, extends to another one of the commissure post tips, and then extends in an inflow direction back to the valve holder, and a second end tied to the valve holder, wherein the middle section crosses the flow axis of the valve between the commissure post tips; an adapter shaped to conform to an inflow side of the valve holder and attached thereto, the adapter defining a central aperture generally aligned with the valve holder central aperture and having a bridge across the aperture with a threaded nut centered thereon; and a commissure constriction rod arranged to slide longitudinally through the valve holder aperture and adapter aperture, the rod having a closed bottom end toward the outflow direction and an open top end toward the inflow direction surrounded by a rim larger than the aperture of the valve holder but smaller than the aperture of the adapter, wherein a male threaded member may be screwed through the threaded nut of the adapter until it contacts the closed bottom end of the rod and forces the rod in an outflow direction from an undeployed position into contact with the middle sections of the attachment sutures that cross the flow axis, the rod being movable farther in the outflow direction to a deployed position which places the attachment sutures in tension and accordingly pulls the commissure post tips inward. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8)
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9. A storage system for a flexible leaflet prosthetic heart valve that helps prevent suture looping, comprising:
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a storage jar having a bottom portion and a lid; a packaging sleeve that fits closely within the storage jar and defines a hollow inner space; a disc-shaped clip connected to the packaging sleeve; a heart valve having an inflow end and an outflow end and a flow axis therebetween, the valve including a plurality of generally axially-extending flexible commissure posts that end in tips circumferentially-spaced around the outflow end that support occluding flexible leaflets of the valve; a valve holder that contacts the inflow end of the valve and has a central aperture, the valve holder being removably secured to the disc-shaped clip such that the heart valve is suspended within the hollow inner space of the packaging sleeve; a bridge held stationary with respect to the valve holder and having a threaded nut thereon; a plurality of attachment sutures each having first and second ends tied to the valve holder and a middle section that extends along two of the valve commissure posts and crosses the flow axis of the valve between the commissure post tips; and a commissure constriction rod arranged to slide longitudinally through the valve holder aperture, the rod having a closed bottom end toward the outflow direction and an open top end toward the inflow direction, wherein a male threaded member may be screwed through the threaded nut of the bridge until it contacts the closed bottom end of the rod and forces the rod in an outflow direction from an undeployed position until it contacts the middle sections of the attachment sutures on the flow axis connecting the valve holder to the prosthetic heart valve, the rod then being movable farther in the outflow direction to a deployed position which places the attachment sutures in tension and accordingly pulls the commissure post tips inward. - View Dependent Claims (10, 11, 12, 13, 14, 15, 16)
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17. A storage system for a flexible leaflet prosthetic heart valve that automatically actuates a commissure constriction mechanism, comprising:
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a storage jar having a bottom portion and a lid attached thereon; a heart valve having an inflow end and an outflow end and a flow axis therebetween, the valve including a plurality of generally axially-extending flexible commissure posts that end in tips circumferentially-spaced around the outflow end that support occluding flexible leaflets of the valve; a valve holder including a mechanism for pulling the commissure post tips inward; and structure within the storage jar that actuates the mechanism for pulling the commissure post tips inward upon detaching the lid from the bottom portion. - View Dependent Claims (18, 19, 20, 21, 22)
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Specification