DRY PROSTHETIC HEART VALVE PACKAGING SYSTEM

摘要

Packaging for prosthetic heart valves including an assembly for stabilizing dry prosthetic tissue implants such as heart valves during storage. The packaging assembly includes a primary sterile barrier that permits gas sterilization of the tissue implant, and a secondary sterile barrier that prevents oxidation of the implant during storage. Tissue heart valves are placed inside an inner tray and sealed with a gas-permeable lid. The inner tray is placed within an outer sterile barrier and the assembly is sterilized. The outer sterile barrier may include a double seal so that a first gas-permeable seal can be closed for sterilization, after which a second gas-impermeable seal is closed to seal out any further oxygen contact with the tissue implant. Alternatively, the inner tray is placed within a sterile pouch and the assembly gas-sterilized, and then the entire assembly is placed within another pouch that provides an impermeable barrier.

主权项

1. A packaging assembly for storing a bioprosthetic heart valve without a liquid preservative solution, the packaging assembly comprising:
a sub-assembly comprising a holder, a clip member and a protective cage,
the holder attached to an inflow end of the bioprosthetic heart valve, the holder comprising a shaft;the clip member comprising a radial slot for receiving the shaft of the holder; andthe protective cage comprising an upper end and enclosing the bioprosthetic heart valve when the upper end is attached to the clip member; and a storage tray comprising a cavity for housing the sub-assembly, the storage tray comprising a stepped ledge to suspend the sub-assembly within the cavity; wherein the packaging assembly does not comprise a liquid preservative.