Isolation tube
Inventors
Ronsick, Christopher S. • Ririe, Kirk • Wilson, Mark S. • Walsh, John D. • Hill, Ryan T.
Assignees
Biomerieux Inc • Biofire Defense LLC
Publication Number
US-12220695-B2
Publication Date
2025-02-11
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 provides separation containers, assemblies, and methods for extracting a portion of a sample, such as microorganisms, for use or testing following centrifugation. The separation container includes a body with an internal chamber and an opening, a seal covering the opening, and a plunger that can be actuated to open the seal and express a portion of the sample. The body is configured to receive a sample, and the seal ensures containment until it is intentionally opened for sample recovery.
This invention addresses limitations in conventional microbial separation methods where multiple handling steps, containers, and user interventions are required for lysing, washing, decanting, and spinning. Previous systems are complex, risk contamination, require significant training, and may damage microorganisms, hindering viability for downstream testing. Furthermore, recovery of consistent pellets is difficult, leading to imprecise sample transfer and increased safety risks for operators.
The separation container of the invention allows simplified, controlled, and repeatable recovery of a concentrated sample, such as a microorganism pellet. The plunger is designed to sealingly engage the body at the pellet region, build pressure during actuation, and open the seal to expel the pellet. Designs include features such as a rheological control member to minimize mixing with a density cushion during loading, a flexible sealing member for actuation, and compatibility with sample collecting vessels to facilitate clean and easy sample transfer for downstream analytical techniques.
Claims Coverage
The independent claims and appended paragraphs of this patent disclose multiple inventive features relating to sample separation containers, retainer-plunger assemblies, and associated methods.
Separation container with actuable plunger and seal
A separation container comprising: - A body defining an internal chamber with an opening for receiving a sample. - A seal disposed across the opening to seal the body. - A plunger movably disposed at least partially inside the internal chamber, configured to be actuated to open the seal and express a portion of the sample. - The plunger may be configured to allow the sample to pass by during centrifugation, but to then seal and divide the chamber upon actuation, enabling extraction of a concentrated pellet.
Rheological control member for sample integrity
A separation container as above further comprising: - A rheological control member disposed in the internal chamber, between the plunger and the wall of the chamber. - The rheological control member may define a bore through which the plunger passes, and may restrict or prevent mixing of the sample and a density cushion during preparation and centrifugation. - The rheological control member may have specified density and buoyancy properties.
Retainer-plunger assembly with rotational locking/unlocking
A retainer-plunger assembly, wherein: - The separation container's body includes a retainer with an annular wall and at least one retaining member. - The plunger has a longitudinal member with at least one locking member. - The retainer is configured to releasably engage the plunger in a rotationally locked state such that the plunger cannot move axially during centrifugation, and the plunger can be unlocked by rotating it in the opposite direction for actuation after centrifugation.
Flexible sealing member facilitating plunger actuation
A separation container further comprising: - A flexible sealing member at least partially covering a second opening of the body, into which the plunger extends. - Compression of the flexible sealing member actuates the plunger to open the seal and extract a portion of the sample, while maintaining a seal at the second opening.
Sample collecting vessel integration
A separation container further comprising: - A sample collecting vessel configured to engage the body and surround the opening, collecting sample portions passing through the opened seal for downstream use or testing.
Specified method for centrifugation and pellet extraction
A method of using a separation container, comprising: 1. Disposing a sample into a separation container with a body, internal chamber, seal, plunger, and optionally, a rheological control member or sample collecting vessel. 2. Centrifuging the separation container to create a pellet from a portion of the sample within the internal chamber. 3. After centrifugation, actuating the plunger to open the seal and express the pellet from the container. - Steps may include producing the sample by lysing or culturing, and expressing the pellet into a sample collecting vessel suitable for downstream testing.
These features collectively cover apparatus, assemblies, and methods for controlled separation, concentration, and extraction of a sample—especially microorganisms—by means of a sealed container with an actuable plunger, optional rheological control, secure mechanical retention during centrifugation, and integration with sample collection tools.
Stated Advantages
Enables rapid, robust, and reliable recovery of microorganism pellets without multiple handling steps or containers.
Minimizes user training and expertise required for consistent sample recovery.
Reduces risk of contamination and exposure by providing contained, sealed extraction and transfer.
Preserves viability of microorganisms for downstream tests such as AST and culturing.
Allows use of whole blood or various specimen types without prior culturing or complex preparation.
Prevents mixing of density cushion and sample during preparation, maintaining separation efficiency.
Facilitates handling of low-volume or high-volume samples for a variety of microorganism types.
Documented Applications
Separation and concentration of microorganisms from clinical and non-clinical samples for downstream testing.
Preparation of samples for antibiotic susceptibility testing (AST).
Sample recovery for culturing microorganisms, including use with whole blood, urine, nasal, buccal, or other body fluid samples.
Preparation of pellets suitable for identification by mass spectrometry (e.g. MALDI-TOF).
Preparation of samples for analysis by nucleic acid amplification techniques, spectroscopy (Raman, FTIR), immunoassay techniques, probe-based assays, and agglutination tests.
Processing of yeast and bacterial samples from blood culture bottles for identification and susceptibility testing.
Use with foodstuffs, cell cultures, biopharmaceuticals, cosmetics, water, and parenterally-administered fluids to test for microorganisms.
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