Assemblies and methods of sterilizing a wet stored prosthetic heart valve
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 interior portions 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 mechanical seal member or formation of multiple seals so that areas proximate the seals are also sterilized during the sterilization process.
1. A method of packaging an implant, the method comprising the steps of:
providing an assembly including a storage container in which the implant is positioned along with a sterilizing fluid and a first portion of an elongated delivery device; wherein the implant is loaded onto the first portion of the delivery device;
forming a first seal at a first location to retain the sterilizing fluid within the storage container at a first location along a second portion of the delivery device;
conducting a first sterilization process;
releasing the first seal at the first location;
forming a second seal at a second location to retain the sterilization fluid within the storage container at a second location along the second portion of the delivery device; and
conducting a second sterilization process of the assembly.
2. The method of claim 1 , wherein the first seal is formed by heat shrink material.
3. The method of claim 1 , wherein the first seal is formed by a sealing member; further wherein the step of forming the second seal includes moving a position of the sealing member along a length of the second portion of the delivery device.
4. The method of claim 3 , wherein the sealing member includes a split ring connected to a sterilization container.
5. The method of claim 4 , wherein the sterilization container includes a stopcock.
6. The method of claim 5 , wherein the first sterilization process includes filling and draining the sterilization container with sterilization fluid via the stopcock.
7. The method of claim 4 , wherein the sterilization container includes a sealing piece through which the second portion of the delivery device is positioned.
8. The method of claim 7 , wherein the sealing piece is rotated to form the second seal.
9. The method of claim 4 , wherein the first sterilization process includes filling the storage container and the sterilization container with sterilizing fluid.
10. The method of claim 1 , wherein the step of forming the second seal includes forming the second seal against the second portion of the delivery device distal to where the first seal was formed.
11. The method of claim 1 , wherein the storage container includes a stopcock.
12. The method of claim 1 , wherein at least one of the first and second seals are formed with flashspun high-density polyethylene fiber material.
13. The method of claim 1 , wherein the second location is within the storage container.
14. The method of claim 1 , wherein the first and second locations are proximal with respect to the implant.
15. A method of packaging an implant, the method comprising the steps of:
providing an assembly including a storage container in which the implant is positioned along with a sterilizing fluid and a first portion of an elongated delivery device; wherein the implant is loaded onto the first portion of the delivery device;
forming a first seal with a sealing member to retain the sterilizing fluid within the storage container at a first location along a second portion of the delivery device;
conducting a first sterilization process;
forming a second seal by moving a position of the sealing member along a length of the second portion of the delivery device to a second location along the second portion of the delivery device to retain the sterilization fluid within the storage container; and
conducting a second sterilization process of the assembly.
16. The method of claim 15 , wherein the sealing member is connected to a sterilization container; further wherein the sterilization container includes a stopcock.
17. The method of claim 16 , wherein the first sterilization process includes filling and draining the sterilization container with sterilization fluid via the stopcock.
18. The method of claim 16 , wherein the sterilization container includes a sealing piece through which the second portion of the delivery device is positioned.
19. The method of claim 18 , wherein the sealing piece is rotated to form the second seal.
20. The method of claim 16 , wherein the first sterilization process includes filling the storage container and the sterilization container with sterilizing fluid.