Assemblies and methods of sterilizing a wet stored implant
AssigneeMedtronic Vascular, Inc.
InventorsNiall Duffy, Stephen Montgomery
Life of this patent
Estimating the term…
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.
Claims20
An assembly comprising:
- a sealed pouch;
- a first portion of a delivery device supporting an implant in the sealed pouch;
- a container housing sterilization fluid, the implant and at least part of the first portion of the delivery device;
- wherein the container includes an opening and a first shaft seal positioned in the opening and against the first portion of the delivery device;
- and
- a positioning apparatus;
- wherein the positioning apparatus is configured to move the container along the first portion of the delivery device.
A method of sterilizing components of an assembly, the method comprising the steps of:
- providing an assembly including:
- a sealed pouch;
- a delivery device supporting an implant in the sealed pouch;
- a container in the 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;
- and
- a positioning apparatus, wherein the positioning apparatus is configured to move the container along the first portion of the delivery device from a first position to a second position;
- actuating the positioning apparatus to move the container along the first portion of the delivery device into the 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.