PROSTHETIC HEART VALVE PACKAGING AND DEPLOYMENT METHODS
First Claim
1. 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.
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.
52 Citations
20 Claims
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1. A method of preparing a packaged prosthetic heart valve for implant, comprising:
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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 (2, 3, 4, 5, 6, 7)
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8. A method of preparing a packaged prosthetic heart valve for implant, comprising:
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providing a packaged prosthetic heart valve having flexible leaflets, 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 having a leaflet parting member thereon through the middle of the heart valve from the inflow end to the outflow end past the flexible leaflets and coupling the leaflet parting member to the valve holder; removing the assembly of the valve and holder from the jar using the shaft; attaching a valve delivery tube to the leaflet parting member from the outflow side of the valve; and detaching the shaft from the leaflet parting member. - View Dependent Claims (9, 10, 11, 12, 13)
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14. A method of preparing a packaged prosthetic heart valve for implant, comprising:
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opening a jar containing a packaged prosthetic heart valve having flexible leaflets therein, the 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 in the 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 past the flexible leaflets and coupling the shaft to the valve holder; removing the assembly of the valve and valve holder from the jar using the shaft; securing a valve delivery tube with respect to the valve holder on the outflow side of the valve; and detaching the shaft from the valve holder. - View Dependent Claims (15, 16, 17, 18, 19, 20)
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Specification