Method of sterilizing medical device
Inventors
Assignees
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Publication Number
US-12485218-B2
Publication Date
2025-12-02
Expiration Date
Abstract
A method of sterilizing a cartridge that has a side wall and a medicant in the cartridge. The cartridge is placed within an outer sleeve and the outer sleeve is sealed to the side wall of the cartridge with a wiper seal to form a hermetic microbial barrier. A breathable microbial membrane is provided over one end of the sleeve. The cartridge and the outer sleeve are subjected to gas sterilization in a sterilization chamber. Any sterilizing gas remaining after sterilization is removed.
Core Innovation
The invention relates to a method of sterilizing a cartridge having a side wall and a medicant within the cartridge by placing the cartridge within an outer sleeve of a sterilization arrangement. The outer sleeve is sealed to the side wall with a wiper seal to form a hermetic microbial barrier, and a breathable microbial membrane is provided over one end of the outer sleeve. A gas passageway is provided between the breathable microbial membrane and the wiper seal to permit sterilizing gas to pass through the breathable microbial membrane to the wiper seal.
The disclosed approach subjects the cartridge and the outer sleeve to gas sterilization, and removes any sterilizing gas remaining after the gas sterilization. The structure uses the hermetic microbial barrier formed by the wiper seal in combination with a pierceable breathable microbial membrane to enable sterilizing gas to reach the wiper seal through the gas passageway.
The disclosure also describes a sterilization arrangement that includes a sterilization chamber and a cartridge having a piston at a first end and a septum at a second end, with a medicant within the cartridge and a sleeve extending about the cartridge. The arrangement includes a needle hub with a needle having a first piercing tip located proximate the septum and a second piercing tip located proximate an end of the sleeve, and a wiper seal between the cartridge side wall and the sleeve forming a hermetic seal.
A pierceable breathable microbial membrane extends across the end of the sleeve proximate the second piercing tip, and a gas passageway is provided between the breathable microbial membrane and the wiper seal to permit a sterilizing gas to pass through the breathable microbial membrane to the wiper seal. The arrangement further includes optional covering of the breathable microbial membrane with a cap and a coil spring mounted between the needle hub and the end of the sleeve.
Claims Coverage
The partial content provides two independent claims, a method claim and an apparatus or arrangement claim, with additional dependent claims refining positioning, optional covering, sterilizing gas selection, and mechanical details. Across the independent claims, there are 7 principal inventive aspects.
Hermetic microbial barrier via wiper seal between cartridge side wall and outer sleeve
Sealing the outer sleeve to the side wall of the cartridge with a wiper seal to form a hermetic microbial barrier; the wiper seal forms a hermetic seal between the side wall of the cartridge and the sleeve.
Breathable microbial membrane provided over an end of the outer sleeve
Providing a breathable microbial membrane over one end of the outer sleeve; and a pierceable breathable microbial membrane extending across the end of the sleeve proximate the second piercing tip.
Gas passageway enabling sterilizing gas to reach the wiper seal
Providing a gas passageway between the breathable microbial membrane and the wiper seal to permit sterilizing gas to pass through the breathable microbial membrane to the wiper seal.
Gas sterilization of the cartridge in the sealed sleeve arrangement
Subjecting the cartridge and the outer sleeve to a gas sterilization in the sterilization arrangement.
Removal of sterilizing gas remaining after gas sterilization
Removing any sterilizing gas remaining after the gas sterilization.
Needle with first and second piercing tips positioned proximate septum and sleeve end
Providing a needle hub and a needle having a first piercing tip and a second piercing tip, with the first piercing tip located proximate the septum and the second piercing tip located proximate an end of the sleeve.
Sterilization arrangement with sterilization chamber and cartridge piston/septum/sleeve
A sterilization arrangement comprising a sterilization chamber; a cartridge having a side wall, a piston at a first end and a septum at a second end, a medicant within the cartridge, and a sleeve extending about the cartridge; the needle hub and needle; the hermetic wiper seal; the pierceable breathable microbial membrane; and the gas passageway.
Across the independent claims, the core inventive coverage is directed to combining a wiper seal forming a hermetic microbial barrier with a breathable microbial membrane and a gas passageway so that sterilizing gas can pass through the breathable microbial membrane to the wiper seal in a gas sterilization process, together with a needle having first and second piercing tips positioned proximate the septum and the sleeve end. The method claim further includes removing any sterilizing gas remaining after gas sterilization.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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