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-11090646-B2
Publication Date
2021-08-17
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 a separation container assembly, system, and associated method for extracting a portion of a sample for use or testing. The separation container includes a body defining an internal chamber with an opening at one end, a seal across the opening to contain the sample, and a plunger movably disposed at least partially inside the chamber. The plunger is configured to open the seal upon actuation, enabling the expression and extraction of a concentrated portion (pellet) of the sample.
The problem being addressed is that existing sample preparation devices for microorganism separation require multiple complex steps—such as separate lysing, decanting, washing, and spinning—often involving manual transfers between containers and delicate handling, which can be hazardous, imprecise, and dependent on user skill. These conventional processes may not preserve microorganism viability and can risk inconsistent results and increased contamination risk, especially with dangerous samples.
The core innovation described involves a separation container and associated devices that enable a sample to be separated (for example, by centrifugation) and permit extraction of a concentrated portion (such as pelleted microorganisms) with minimal handling and fewer operational steps. Various structural features—such as internal chamber geometry, a seal, a movable plunger with sealing ribs, and optionally a rheological control member—facilitate reliable, repeatable separation and extraction. The device can be preloaded with reagents (e.g., density cushion, lysing solutions), is compatible with downstream testing, and may accommodate a sample collecting vessel for direct transfer, minimizing user exposure and error.
Claims Coverage
The patent contains one independent claim, which introduces a retainer and plunger assembly within a separation container for holding and releasing the plunger at a predetermined position, along with dependent claims specifying the configuration and interaction of the retainer, plunger, and associated members.
Retainer and plunger assembly with releasable engagement
An assembly where a retainer within the body of a separation container has an annular wall defining a central opening. A plunger with a longitudinal member is configured to pass through this opening. The retainer is designed to releasably engage the plunger, holding it at a predetermined position to prohibit movement along the longitudinal axis until release is desired.
Configuration of retaining and locking members for secure and releasable holding
The retainer includes at least one retaining member (such as a support projection, stop wall, or locking tab) while the plunger includes at least one locking member (e.g., C-shaped wall or locking wall). These components are configured so that the retainer releasably engages the plunger by mechanical interaction, including features to increase resistance to rotation and axial movement, enabling the plunger to be locked in place or rotated for disengagement.
Operation during centrifugation and post-centrifugation use
- The retainer is positioned within the internal chamber of the separation container body, holding the plunger in the predetermined position during centrifugation to resist centripetal forces. - After centrifugation, the user can disengage the plunger (typically by rotating it), enabling actuation of the plunger along the longitudinal axis to open the seal and express the sample portion.
Inclusion of flexible sealing member and cap for actuation
A flexible sealing member disposed at a second end of the container body and a cap threaded onto the body, with portions configured so the plunger may extend into the flexible member and be actuated by gripping and rotating the plunger through the flexible member.
The independent claim covers a separation container assembly with a retainer structure that securely holds and releases a plunger in a controlled manner, especially during and after centrifugation, greatly improving sample extraction accuracy, user safety, and operational robustness.
Stated Advantages
Enables separation and extraction of samples in fewer operations with only a single centrifugation step, reducing user handling and complexity.
Reduces risk of contamination and user exposure since the user does not need to handle or transfer microorganisms between containers.
Allows for consistent, reproducible results and reduces dependence on user training or experience for accurate sample recovery.
Preserves viability of separated microorganisms, facilitating downstream applications that require live cells, like antibiotic susceptibility testing or culturing.
Provides a controlled and repeatable process for sample preparation, making the device robust and suitable for use by untrained users.
Improves safety during preparation and recovery of dangerous microorganisms by minimizing human interaction.
Documented Applications
Preparation and extraction of pelleted microorganisms from clinical samples (such as blood, urine, swabs, or other biological fluids) for use in downstream laboratory testing.
Preparation of samples suitable for antibiotic susceptibility testing (AST) and phenotypic identification methods.
Preparation of pellets suitable for identification by mass spectrometry, such as MALDI-TOF.
Preparation of samples for other analytical techniques, including nucleic acid amplification, immunoassays, spectroscopy techniques (e.g., Raman, FTIR), probe-based assays, and agglutination tests.
Processing non-clinical samples (e.g., food products, biopharmaceuticals, water, cosmetics) for microorganism detection and testing.
Facilitates both medical and veterinary sample preparation protocols.
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