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; and
a plurality of upstanding posts having longer lengths than the legs projecting upward from the clip, at least one post being provided on each of the two halves of the clip.
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.
-
Citations
20 Claims
-
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; and a plurality of upstanding posts having longer lengths than the legs projecting upward from the clip, at least one post being provided on each of the two halves of the clip. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8)
-
-
9. A packaged prosthetic heart valve assembly, comprising:
-
a jar having a closed bottom; a prosthetic heart valve having an inflow end and an outflow end; a valve holder attached to the outflow end of the valve; 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 oriented toward the bottom of the jar. - View Dependent Claims (10, 11, 12, 13, 14, 15)
-
-
16. A method of preparing a packaged prosthetic heart valve for implant, comprising:
-
providing a packaged prosthetic heart valve having an inflow end and an outflow end, a valve holder being assembled to the outflow end of the valve and the assembly of the valve and holder being positioned within a jar with the holder oriented toward the bottom of the jar; extending a shaft through the middle of the heart valve from the inflow end to the outflow end and coupling the shaft to the valve holder; and removing the assembly of the valve and holder from the jar using the shaft. - View Dependent Claims (17, 18, 19, 20)
-
Specification