Assemblies including a pre-loaded implant and methods of sterilizing assemblies
Aspects of the disclosure relate to storage assemblies including at least part of a delivery device and an implant. The storage assemblies are configured to trap sterilizing ethylene oxide gas using its high water solubility and converting the escaped ethylene oxide to less detrimental ethylene glycol and ethylene chlorohydrin to protect the implant from damage. In one example, the storage assembly includes an inner container housing the implant and sterilizing fluid and an outer container positioned over the inner container, wherein the outer container is at least partially filled with aqueous water. The implant may be a prosthetic heart valve. Aspects of the disclosure also relate to methods of sterilizing the storage assemblies of the disclosure.
1 . A storage assembly comprising:
a delivery device including a shaft having an implant loaded thereto;
an inner container surrounding the implant and sealed to the shaft; wherein the inner container contains sterilizing fluid; and
an outer container surrounding the inner container and sealed to the shaft; wherein the outer container contains aqueous water.
2 . The storage assembly of claim 1 , wherein the outer container contains activated carbon.
3 . The storage assembly of claim 1 , wherein the implant is a prosthetic heart valve.
4 . The storage assembly of claim 1 , wherein the inner container is sealed to the shaft with a first seal; wherein there is a sufficient amount of aqueous water to cover the inner container and the first seal.
5 . The storage assembly of claim 4 , wherein there is a sufficient amount of aqueous water to cover the inner container and the first seal regardless of how the storage assembly is oriented.
6 . The storage assembly of claim 1 , wherein the aqueous water is selected from the group consisting of purified water and distilled water.
7 . The storage assembly of claim 1 , wherein the sterilizing fluid contains glutaraldehyde.
8 . The storage assembly of claim 7 , wherein the sterilizing fluid includes a buffer solution.
9 . A method of sterilizing an assembly, the method comprising;
providing storage assembly including:
a delivery device having:
a shaft having an implant loaded thereto;
an inner container surrounding the implant and fluidly sealed to the shaft; wherein the inner container contains sterilizing fluid; and
an outer container surrounding the inner container and fluidly sealed to the shaft; wherein the outer container contains aqueous water;
sterilizing the storage assembly with ethylene oxide gas; and
converting at least a portion of the ethylene oxide gas into ethylene glycol and ethylene chlorohydrin when the portion of ethylene oxide gas contacts the aqueous water.
10 . The method of claim 9 , wherein the outer container also contains activated carbon and the method further includes the activated carbon absorbing at least a portion of the ethylene glycol and ethylene chlorohydrin.
11 . The method of claim 9 , wherein the inner container is sealed to the shaft with a first seal; wherein there is a sufficient amount of aqueous water to cover the inner container and the first seal.
12 . The method of claim 11 , wherein there is a sufficient amount of aqueous water to cover the inner container and the first seal regardless of how the storage assembly is oriented.
13 . The method of claim 9 , wherein the aqueous water is selected from the group consisting of deionized water and distilled water.
14 . The method of claim 9 , wherein the sterilizing fluid contains glutaraldehyde.
15 . The method of claim 14 , wherein the sterilizing fluid includes a buffer solution.
16 . The method of claim 9 , wherein the implant is a prosthetic heart valve.