Apparatus and methods for maintaining sterility of a specimen container
Inventors
Bullington, Gregory J. • Gaw, Shan E. • Miazga, Jay M. • Pong, Skooks • Eubanks, Shannon E
Assignees
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Publication Number
US-12083234-B2
Publication Date
2024-09-10
Expiration Date
Abstract
An apparatus includes a fluid reservoir, a sterilization member, and a transfer adapter. The sterilization member operably couples to the fluid reservoir. The sterilization member is configured to be transitioned between a first configuration, in which the sterilization member obstructs an inlet surface of the fluid reservoir and maintains the inlet surface in a substantially sterile environment, and a second configuration, in which the inlet surface is unobstructed. The transfer adapter is configured to be placed in fluid communication with a portion of a patient. The transfer adapter is configured to move relative to the sterilization member from a first position to a second position such that a surface of the transfer adapter contacts the sterilization member to transition the sterilization member to the second configuration. The fluid reservoir is placed in fluid communication with the transfer adapter when the transfer adapter is in the second position.
Core Innovation
The invention relates to an apparatus for parenteral bodily-fluid sampling that maintains sterility of a specimen/container inlet by transitioning a sterilization device member between a first configuration and a second configuration. In the first configuration, the surface of the sterilization device obstructs the inlet surface and maintains the inlet surface in a sterilized environment. In the second configuration, the inlet surface becomes unobstructed by the surface of the sterilization device so that fluid transfer can occur.
A transfer device is moved relative to the sterilization device so that the transfer device receives at least a portion of the sterilization device in the first configuration and then transitions the sterilization device to the second configuration. As the transfer device is moved from a first position to a second position, a surface of the transfer device contacts the sterilization device to transition it. The transfer device defines a flow path that places the inlet of the transfer device in fluid communication with the fluid reservoir when the transfer device is in the second position.
The sterilization device includes a surface that defines at least a portion of a sterilized environment and includes a disinfection agent that is in contact with the inlet surface. The sterilization device is coupled to a portion of the fluid reservoir such that the disinfection agent contacts the inlet surface, supporting maintenance of the inlet surface in the sterilized environment when obstructed. Modular collection device embodiments include a housing defining a sterile environment volume and removable seal/opening mechanisms coordinated with movement between configurations.
Claims Coverage
The partial content provides one independent claim describing the overall apparatus architecture and dependent claims that narrow or refine claim aspects. The independent claim includes multiple inventive features, especially the transition between sterilized and unobstructed configurations coordinated with a moved transfer device and the presence of a disinfection agent contacting the inlet surface.
Sterilization device transitioned between obstructing and unobstructed inlet configurations
A sterilization device coupled to the fluid reservoir is transitioned between a first configuration that obstructs the inlet surface and maintains the inlet surface in a sterilized environment and a second configuration in which the inlet surface is unobstructed by the surface of the sterilization device.
Transfer device movement transitions the sterilization device and establishes a flow path
A transfer device with an inlet and walls defining an inner volume receives at least a portion of the sterilization device in the first configuration in response to the transfer device being moved relative to the sterilization device, contacts the sterilization device as the transfer device is moved to the second position to transition the sterilization device, and defines at least a portion of a flow path that places the inlet of the transfer device in fluid communication with the fluid reservoir when in the second position.
Disinfection agent contacts the reservoir inlet surface within the sterilized environment
The sterilization device member includes a disinfection agent defining at least a portion of the sterilized environment, and the sterilization device is coupled to a portion of the fluid reservoir such that the disinfection agent is in contact with the inlet surface.
Sterilized environment defined by a housing inner volume
A housing with an inner volume forms the sterilized environment when the sterilization device is in the first configuration, and the fluid reservoir is disposed within the inner volume of the housing.
Removably remove sterilization device from housing in second configuration
The sterilization device is at least partially removed from the housing when the sterilization device is in the second configuration.
Sterilization device as a selected sheet, foil, cap, membrane, or diaphragm
The sterilization device is at least one selected from a sheet, a foil, a cap, a membrane, or a diaphragm.
Seal and opening mechanism coordinated with transfer-device movement
The sterilization device includes a disinfection agent and an opening in fluid communication with the disinfection agent that is sealed in the first configuration and becomes unobstructed in the second configuration by the transfer device contacting a seal member.
Removably coupled sterilization device and reservoir volume forming sterilized environment
The sterilization device is removably coupled to a portion of the fluid reservoir such that the sterilization device and fluid reservoir collectively define a volume forming at least part of the sterilized environment, with the inlet surface disposed within that volume in the first configuration and decoupling placed by the transfer device to reach the second configuration.
Overall, the claim coverage centers on an apparatus that transitions a sterilization device between configurations to obstruct and then unobstruct a fluid reservoir inlet, coordinated with movement of a transfer device that both transitions the sterilization device and establishes fluid communication. The claim set further specifies that the sterilization device includes a disinfection agent contacting the inlet surface, and dependent claims refine how the sterilized environment is defined and how removal, structural forms, and seal/opening mechanisms are coordinated with the transition.
Stated Advantages
Reduce external microbial contamination and false diagnostic results.
Documented Applications
Parenteral bodily-fluid sampling in which a specimen/container inlet is maintained in a sterile environment during transfer from a patient to a fluid reservoir.
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