Prosthetic heart valve packaging and deployment system
First Claim
1. A packaging sleeve formed from a single molded component for securing a prosthetic heart valve within a jar, comprising:
- a generally planar clip having a peripheral edge and an entry slot leading therefrom to a central docking aperture wider than the entry slot, the clip being defined by two substantially similar halves pivotally connected together at a living hinge at the peripheral edge of the clip opposite from the entry slot;
a plurality of lower legs extending downward from the clip that together elevate the clip above and generally parallel to a flat surface on which the sleeve is placed;
a plurality of upstanding posts having longer lengths than the legs and projecting upward from the clip, at least one post being provided on each of the two halves of the clip; and
a plurality of axial ribs extending upward from the clip, at least some of which are distributed around an approximately semi-circular reinforcing wall.
1 Assignment
0 Petitions
Accused Products
Abstract
Packaging for prosthetic heart valves including an assembly for securely retaining a heart valve within a jar and facilitating retrieval therefrom. The assembly includes a packaging sleeve that fits closely within the jar and has a clip structure for securing a valve holder. Contrary to previous designs, in one embodiment the valve holder is directed downward into the jar, and the valve is retained with an inflow end upward. The valve may have flexible leaflets, and a leaflet parting member on the end of the shaft extends through the leaflets and couples with the valve holder. The assembly of the packaging sleeve, valve, and holder can then be removed from the jar and a valve delivery tube connected with the holder, or to the leaflet parting member. The packaging sleeve may be bifurcated into two halves connected at a living hinge to facilitate removal from around the valve/holder subassembly. The packaging system facilitates attachment of the valve delivery tube for use in a quick-connect valve implant procedure.
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Citations
27 Claims
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1. A packaging sleeve formed from a single molded component for securing a prosthetic heart valve within a jar, comprising:
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a generally planar clip having a peripheral edge and an entry slot leading therefrom to a central docking aperture wider than the entry slot, the clip being defined by two substantially similar halves pivotally connected together at a living hinge at the peripheral edge of the clip opposite from the entry slot; a plurality of lower legs extending downward from the clip that together elevate the clip above and generally parallel to a flat surface on which the sleeve is placed; a plurality of upstanding posts having longer lengths than the legs and projecting upward from the clip, at least one post being provided on each of the two halves of the clip; and a plurality of axial ribs extending upward from the clip, at least some of which are distributed around an approximately semi-circular reinforcing wall. - View Dependent Claims (2, 3, 4, 5, 6)
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7. A packaged prosthetic heart valve assembly, comprising:
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a jar having a closed bottom and an open top end closed with a lid, the jar having an axial depth greater than the lid; a prosthetic heart valve having an inflow end and an outflow end; a valve holder that holds the valve during delivery attached to the valve with at least one suture, wherein the valve holder is attached to the prosthetic heart valve with the at least one suture that passes through fabric in the valve and across a cutting guide in the holder to enable the holder to be pulled free from the valve when the suture is severed; and a packaging sleeve sized to fit closely within the jar and rest on the bottom thereof, the sleeve having structure to which the valve holder removably couples such that the holder is located below the prosthetic heart valve when stored within the jar. - View Dependent Claims (8, 9, 10, 11, 12, 13, 14)
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15. A packaged prosthetic heart valve assembly, comprising:
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a jar having a closed bottom and an open top end closed with a lid, the jar having an axial depth greater than the lid; a prosthetic heart valve having an inflow end and an outflow end; a valve holder attached to the valve; and a packaging sleeve formed from a single molded component sized to fit closely within the jar having a generally planar clip with a peripheral edge and an entry slot leading therefrom to a central docking aperture wider than the entry slot, a plurality of lower legs extending downward from the clip that together elevate the clip above and generally parallel to jar bottom, and a plurality of upstanding posts having longer lengths than the legs projecting upward from the clip into proximity with the jar lid, wherein the valve holder couples to the central docking aperture of the clip such that the holder is elevated from the bottom of the jar and located below the prosthetic heart valve when stored within the jar. - View Dependent Claims (16, 17, 18, 19)
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20. A packaged prosthetic heart valve assembly, comprising:
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a jar having a closed bottom and an open top end closed with a lid, the jar having an axial depth greater than the lid; a prosthetic heart valve having an inflow end and an outflow end; a valve holder attached to the valve; and a packaging sleeve having a generally circular periphery as seen from above that fits closely within the jar and an axial dimension that extends substantially the entire axial height of the jar between the bottom and the lid, the packaging sleeve further including a generally planar clip extending radially across the interior of the jar substantially closer to the jar bottom than to the lid, the clip having an entry slot extending from a peripheral edge to a central docking aperture wider than the entry slot, wherein the valve holder couples to the central docking aperture of the clip such that the holder is located below the prosthetic heart valve when stored within the jar. - View Dependent Claims (21, 22, 23, 24)
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25. A packaging sleeve formed from a single molded component for securing a prosthetic heart valve within a jar, comprising:
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a generally planar clip having a peripheral edge and an entry slot leading therefrom to a central docking aperture wider than the entry slot, the clip being defined by two substantially similar halves pivotally connected together at a living hinge at the peripheral edge of the clip opposite from the entry slot; a plurality of lower legs extending downward from the clip that together elevate the clip above and generally parallel to a flat surface on which the sleeve is placed; and a plurality of upstanding posts having longer lengths than the legs and projecting upward from the clip, at least one post being provided on each of the two halves of the clip, wherein each of the upstanding posts extends upward adjacent the peripheral edge of the clip and includes a main wall portion having a slight curvature generally tracking the peripheral edge, and an axial reinforcing rib projecting outward from the main wall portion. - View Dependent Claims (26)
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27. A packaged prosthetic heart valve assembly, comprising:
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a jar having a closed bottom and an open top end closed with a lid, the jar having an axial depth greater than the lid; a prosthetic heart valve having an inflow end and an outflow end; a valve holder that holds the valve during delivery attached to the valve with at least one suture, wherein the holder further includes a central hub having threading that mates with threading on an element of a delivery system; and a packaging sleeve sized to fit closely within the jar and rest on the bottom thereof, the sleeve having structure to which the valve holder removably couples such that the holder is located below the prosthetic heart valve when stored within the jar.
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Specification