Assemblies and methods of sterilizing a wet stored implant
AssigneeMedtronic Vascular, Inc.
InventorsNiall Duffy, Stephen Montgomery
Life of this patent
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Abstract
Aspects of the disclosure relate to “wet” transcatheter prosthetic heart valve or other implant packaging and assemblies in which a prosthetic heart valve or other implant is loaded into a first portion of a delivery device and positioned within a container in which sterilizing fluid is retained to sterilize inside of the container as well as provide moisture to prevent the implant from drying out. The disclosure also relates to methods of sterilizing the disclosed assemblies. Some disclosed methods include at least two sterilizing steps and adjustment of a shaft seal or formation of multiple seals maintaining sterilizing fluid within the container so that areas underneath the shaft seal(s) can also be sterilized.
Claims18
A method of sterilizing a delivery device and an implant, the method comprising the steps of:
- positioning a container and a delivery device supporting an implant in a sealed pouch, the container housing sterilization fluid, the implant and part of a first portion of the delivery device, wherein the container includes an opening and a first seal positioned in the opening and against the first portion of the delivery device at a first position;
- actuating a positioning apparatus to move the container along the first portion of the delivery device from the first position to a second position;
- and
- conducting a dry sterilization process when the container is either in the first position or the second position.
Dependencies are inferred from the claim text.