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 including:
an elongated delivery device;
an implant loaded onto a first portion of the elongated delivery device;
a storage container including a first section and a second section; wherein the implant is positioned within the first section and the first portion of the delivery device is positioned in both the first and second sections;
a first seal positioned to retain sterilization fluid within the first section; and
a second seal positioned between at least a portion of the delivery device and the second section, wherein the first seal is impermeable to liquid and the second seal is gas permeable.
2. The assembly of claim 1 , wherein the first section is filled with sterilization fluid.
3. An assembly including:
an elongated delivery device comprising a first portion;
an implant loaded onto the first portion;
a storage container including a first section and an inlet tube comprising an open end; wherein the implant is positioned within the first section and the first portion of the elongated delivery device is positioned in the first section, through the inlet tube, and through the open end;
sterilization fluid at least partially filling the first section; and
a first seal impermeable to liquid positioned to retain sterilization fluid within the first section, wherein the first seal is placed to seal a space between the first portion of the elongated delivery device and an interior of the inlet tube at an intermediate location of the inlet tube, and an outer segment of the interior of the inlet tube between the open end and the first seal is dry and free from sterilization fluid.
4. The assembly of claim 3 , wherein the first portion of the elongated delivery device comprises a spindle.
5. The assembly of claim 3 , wherein the first section of the storage container comprises a storage area comprising a closed end opposite the open end of the inlet tube.
6. The assembly of claim 3 , wherein the first seal comprises a mechanical seal.
7. The assembly of claim 3 , wherein the storage container comprises a non-porous material.
8. The assembly of claim 7 , wherein the non-porous material comprises film.
9. The assembly of claim 7 , wherein the non-porous material comprises glass.
10. The assembly of claim 3 , wherein the sterilization fluid comprises glutaraldehyde.