Isolation tube
Inventors
Ririe, Kirk • Ronsick, Christopher S. • Wilson, Mark S. • Walsh, John D. • Hill, Ryan T.
Assignees
Biomerieux Inc • Biofire Defense LLC
Publication Number
US-11883818-B2
Publication Date
2024-01-30
Expiration Date
2038-07-26
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Abstract
A separation container for extracting a portion of a sample for use or testing and method for preparing samples for downstream use or testing are provided. The separation container may include a body defining an internal chamber. The body may define an opening, and the body may be configured to receive the sample within the internal chamber. The separation container may further include a seal disposed across the opening, such that the seal may be configured to seal the opening of the body, and a plunger movably disposed at least partially inside the internal chamber. The plunger may be configured to be actuated to open the seal and express the portion of the sample.
Core Innovation
The invention concerns a separation container and related systems for extracting a portion of a sample for use or testing, particularly for separating microorganisms from a biological or non-biological sample through centrifugation. The container includes a body defining an internal chamber with an opening, a seal across the opening, and a plunger movably disposed at least partially inside the chamber. The plunger is configured to be actuated to open the seal and express a portion of the sample, such as a separated pellet of microorganisms.
The problem addressed is that prior sample preparation systems for microorganism recovery require multiple separate steps—such as lysing, washing, decanting, and repeated spinning—often involving multiple containers and substantial user handling. These procedures are heavily dependent on user expertise and training, are not easily controlled or repeatable, and expose users to potentially dangerous microorganisms. Furthermore, existing devices may fail to recover microorganism pellets consistently and may damage viable cells needed for downstream testing.
The invention solves these problems by providing a container that enables separation and extraction of a concentrated microorganism pellet in fewer operations. The container is structured so that, after centrifugation, the plunger can be actuated to open the seal and express a consistent volume of the separated sample with minimal user handling. The design supports precise and repeatable recovery of the desired portion, with features such as a narrowing internal diameter to collect the pellet, sealing engagement of the plunger to fluidically isolate the pellet region, and the option for an integrated sample collecting vessel for downstream testing steps.
Claims Coverage
The patent claims cover two main inventive features concerning the construction and operation of a plunger for sample extraction, and a separation container incorporating such a plunger, both with defined geometric and functional relationships.
Plunger with a plunger seal diameter greater than a portion of the plunger diameter
A plunger for expressing a portion of a sample from a container comprises: - A longitudinal member defining a first distal end, a second distal end, and an axis extending between them. - A plunger seal positioned about the longitudinal member at a location between the first and second distal ends, the plunger seal defining a plunger seal diameter perpendicular to the axis. - At least a portion of the longitudinal member between the plunger seal and the first distal end defines a plunger diameter that is less than the plunger seal diameter. - The outer circumferential surface of the plunger seal is configured to engage a wall of the container. Additional features may include: a solid plunger at the plunger seal location, a recess for the plunger seal, sealing rib(s), chamfered edges, the plunger seal being overmolded or integral, a shoulder between the second distal end and the plunger seal (with the shoulder diameter greater than the plunger seal diameter), and a gripping portion at or near the second distal end.
Separation container with collection region, pellet region, and integrated plunger seal
A separation container comprises: - A container body defining an internal chamber configured to receive a sample, with a first distal container end; a collection region (with collection diameter); and a pellet region (with pellet diameter), where the collection diameter is greater than the pellet diameter and the pellet region is defined between the first distal end and the collection region in the internal chamber. - A plunger configured to be disposed at least partially within the internal chamber, comprising a longitudinal member with a plunger seal positioned about the member at a location between the first and second distal ends, the plunger seal defining a plunger seal diameter perpendicular to the axis. - The plunger seal diameter is greater than or equal to the pellet diameter and less than the collection diameter. - At least a portion of the longitudinal member between the plunger seal and the first distal end defines a plunger diameter that is less than the plunger seal diameter. - The outer circumferential surface of the plunger seal is configured to engage a wall of the container body. Additional features may include: a shoulder that impinges the container body to define maximum plunger displacement, specified axial distances between features to ensure the plunger seal is in the correct position, and support members on the plunger for engaging the container body or a retainer.
The inventive features center on the structural and operational relationship of a plunger and seal, as well as their integration within a specifically designed separation container, to ensure controlled sample extraction and isolation.
Stated Advantages
Enables a user to separate a microorganism from a sample in fewer operations using only a single centrifugation step.
Allows separation and testing of the sample without handling the microorganism and without destroying viable cells, so viable samples may be grown and tested downstream.
Provides a controlled, repeatable process and apparatus that allows an operator to easily, safely, sterilely, and quickly prepare a sample for further testing.
Permits an untrained user to recover a pellet with minimal training and effort and with greater consistency than prior devices.
Improves robustness and precision in recovering pellets regardless of pellet consistency.
Minimizes user exposure to dangerous microorganisms by reducing user interaction.
Reduces the need for multiple containers and equipment, consolidating steps into a single device.
Preserves the viability of microorganisms for downstream applications such as AST, culturing, and phenotypic identification.
Documented Applications
Preparation of viable microorganism pellets suitable for downstream culture in clinical and veterinary applications.
Sample preparation for antibiotic susceptibility testing (AST) and phenotypic identification methods.
Sample preparation for mass spectrometry-based identification, such as MALDI-TOF.
Sample preparation for nucleic acid amplification techniques, spectroscopy techniques (Raman, FTIR), immunoassay techniques, probe-based assays, and agglutination tests.
Testing and recovery of microorganisms from a variety of clinical and non-clinical sample types, including whole blood, urine, body fluids, swabs, foodstuff, water, and pharmaceuticals.
Processing of yeast samples for testing, including washing and resuspension steps.
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