Assemblies for 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. An assembly comprising:
a storage container configured to receive a spindle;
a sterilization container removably connected to the storage container, the sterilization container configured to receive the spindle;
a lid removably connected to a proximal end of the sterilization container, wherein the lid includes an opening configured to receive the spindle;
a reservoir defined at least partially by the storage container, the sterilization container, and the lid; and
a first seal configured to circumscribe the spindle to divide the reservoir into a first area defined at least partially by the sterilization container and the lid, and a second area defined at least partially by the storage container, wherein the first seal is configured to seal against the spindle to provide a fluid-tight seal between the first area and the second area, further comprising a sealing piece comprising the first seal, wherein the sealing piece is removably connected to the storage container.
2. The assembly of claim 1 , further comprising the spindle extending through the opening of the lid, through the first area, through the first seal, and into the second area, wherein the first seal is sealed against the spindle to provide a fluid-tight seal between the first area and the second area, and the opening of the lid is provided with a second seal that is sealed against the spindle to provide a fluid-tight seal between the spindle and the opening of the lid.
3. The assembly of claim 2 , further comprising an implant positioned within the second area of the reservoir.
4. The assembly of claim 3 , wherein the implant comprises a stented prosthetic heart valve loaded over the spindle.
5. The assembly of claim 2 , wherein a first quantity of sterilization fluid is contained within the first area of the reservoir, and a second quantity of sterilization fluid is contained within the second area of the reservoir.
6. The assembly of claim 5 , further comprising an implant submerged within the second quantity of sterilization fluid within the second area of the reservoir.
7. The assembly of claim 6 , wherein the implant comprises a stented prosthetic heart valve loaded over the spindle.
8. The assembly of claim 1 , wherein the sealing piece is removably connected to the sterilization container.
9. The assembly of claim 1 , wherein the first seal comprises a plurality of prongs extending from a central axis of the first seal.
10. The assembly of claim 9 , wherein the plurality of prongs are configured to be radially compressed to seal against the spindle.
11. The assembly of claim 1 , wherein the lid is formed from two pieces, wherein each piece defines a portion of the opening of the lid.
12. A method of sterilizing an implant with an assembly comprising:
a storage container configured to receive a spindle;
a sterilization container removably connected to the storage container, the sterilization container configured to receive the spindle;
a lid removably connected to a proximal end of the sterilization container, wherein the lid includes an opening configured to receive the spindle;
a reservoir defined at least partially by the storage container, the sterilization container, and the lid; and
a first seal configured to circumscribe the spindle to divide the reservoir into a first area defined at least partially by the sterilization container and the lid, and a second area defined at least partially by the storage container, wherein the first seal is configured to seal against the spindle to provide a fluid-tight seal between the first area and the second area, the method comprising:
placing the implant loaded on a spindle within the second area;
removably connecting the sterilization container to the storage container with the spindle extending through the first area, wherein the first seal circumscribes the spindle to divide the reservoir into the first area and the second area and seals against the spindle to provide the fluid-tight seal between the first area and the second area;
removably connecting the lid to the proximal end of the sterilization container with the spindle extending through the opening of the lid; and
at least partially filling the first area and the second area with sterilization fluid.
13. The method of claim 12 , further comprising draining the sterilization fluid from the first area.
14. The method of claim 13 , further comprising removing the sterilization container from the storage container.
15. The method of claim 14 , further comprising packing the storage container, first seal, and implant in a sealed pouch, and then performing a dry sterilization process.
16. The method of claim 12 , further comprising draining the sterilization fluid from the second area.
17. The method of claim 16 , further comprising flushing the implant with saline after draining the sterilization fluid from the second area.
18. An assembly comprising:
a storage container configured to receive a spindle;
a sterilization container removably connected to the storage container, the sterilization container configured to receive the spindle;
a lid removably connected to a proximal end of the sterilization container, wherein the lid includes an opening configured to receive the spindle;
a reservoir defined at least partially by the storage container, the sterilization container, and the lid; and
a first seal configured to circumscribe the spindle to divide the reservoir into a first area defined at least partially by the sterilization container and the lid, and a second area defined at least partially by the storage container, wherein the first seal is configured to seal against the spindle to provide a fluid-tight seal between the first area and the second area, wherein the first area is provided with a first valve configured to be moved from a closed orientation to an open orientation to drain fluid from the first area and/or fill the first area with fluid.
19. An assembly comprising:
a storage container configured to receive a spindle;
a sterilization container removably connected to the storage container, the sterilization container configured to receive the spindle;
a lid removably connected to a proximal end of the sterilization container, wherein the lid includes an opening configured to receive the spindle;
a reservoir defined at least partially by the storage container, the sterilization container, and the lid; and
a first seal configured to circumscribe the spindle to divide the reservoir into a first area defined at least partially by the sterilization container and the lid, and a second area defined at least partially by the storage container, wherein the first seal is configured to seal against the spindle to provide a fluid-tight seal between the first area and the second area, wherein the second area is provided with a second valve configured to be moved from a closed orientation to an open orientation to drain fluid from the second area and/or fill the second area with fluid.