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-11383231-B2
Publication Date
2022-07-12
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 for extracting a portion of a sample for use or testing, particularly after separation via centrifugation. The core design comprises a body defining an internal chamber with an opening, a seal disposed across the opening, and a movably disposed plunger at least partially inside the internal chamber. The plunger is configured to be actuated to open the seal and express a portion of the sample from the container.
Prior methods for preparing microorganism samples require multiple handling steps, separate containers, and precise user technique, leading to inconsistent results and potential contamination or exposure. These processes were also harsh on microorganisms, making it challenging to obtain highly viable microbial cells required for certain downstream tests. The disclosed invention overcomes these limitations by enabling separation and extraction of a concentrated microorganism sample with fewer operations, often just a single centrifugation step, reducing manual handling and improving repeatability and safety.
The separation container may further include innovative elements such as a plunger with a sealing rib or plunger seal, a rheological control member to prevent mixing of the density cushion and sample, and a sample collecting vessel for receiving the expressed pellet. The design supports precise sample recovery for various downstream applications by fluidically isolating the pellet and providing a controlled mechanism for opening the seal and expressing only the concentrated portion needed.
Claims Coverage
The claims of the patent focus on three main inventive features: the configuration of the separation container with a plunger and seal, the method of expressing a portion of a sample using this system, and a means for fluidically separating the expressed portion during operation.
Separation container with plunger and plunger seal configured for fluidic expression
A separation container comprises: - A container body defining an internal chamber configured to receive a sample, with an opening, a collection region having a collection diameter, and a pellet region having a pellet diameter (the collection diameter is greater than the pellet diameter, and the pellet region is between the opening and the collection region). - A seal disposed across the opening, configured to seal it. - A plunger disposed at least partially within the internal chamber to open the seal, the plunger comprising a longitudinal member with a first and 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, with the plunger seal diameter perpendicular to the axis and greater than or equal to the pellet 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, allowing retention of a volume of sample between the wall of the container, distal end, plunger seal, and the longitudinal member portion. - The first distal end of the plunger is configured to open (e.g., pierce) the seal.
Method for expressing a sample portion using a displacement plunger and sealing engagement
A method is provided for expressing a portion of a sample from a separation container comprising: 1. Displacing the plunger along its axis to cause the plunger seal to engage the container body at the pellet region so the plunger seal and container body retain the sample volume between the wall, distal end, plunger seal, and longitudinal member. 2. Further displacing the plunger to open the seal with the first distal end of the plunger. 3. Further displacing the plunger so that the volume of the sample is expressed from the opening via pressure created by the plunger seal.
Means for fluidically separating the expressed portion during operation
The separation container further comprises: - Means for sealing the opening. - Means for opening the seal and expressing a portion of the sample. - Means for fluidically separating the portion of the sample from other fluid in the internal chamber during expression, attached to the means for opening the seal and expressing the sample. This design is configured so that only the portion of the sample is expressed during operation.
In summary, the independent claims provide broad protection for the separation container structure with the integrated plunger and plunger seal, the method of controlled expression of a specific sample volume by progressive actuation of the plunger, and the mechanism for fluidic isolation of the expressed sample segment during operation.
Stated Advantages
Reduces user handling and manual intervention during sample processing, minimizing contamination risk and exposure to dangerous microorganisms.
Enables consistent, repeatable extraction of a concentrated microorganism portion using fewer operational steps and only a single centrifugation step.
Provides a controlled mechanism for expressing only the concentrated portion, improving sample purity and viability for downstream testing.
Allows usage even by untrained users with minimal training, offering greater consistency and ease of use compared to prior techniques.
Documented Applications
Preparation and extraction of microorganisms from clinical and non-clinical samples for downstream use or testing, including blood, serum, plasma, urine, nasal samples, tissue homogenates, foodstuffs, cell cultures, biopharmaceuticals, cosmetics, water, and more.
Producing viable or non-viable pellets suitable for downstream applications such as antibiotic susceptibility testing (AST), phenotypic identification methods, culture steps, or growth-based downstream testing methods.
Preparation of samples suitable for identification by mass spectrometry (e.g., MALDI-TOF) and other analytical techniques described including nucleic acid amplification, spectroscopy (e.g., Raman, FTIR), immunoassay, probe-based assays, and agglutination tests.
Processing of sample types without culturing beforehand, including whole blood, urine, nasal, buccal swabs, and other body fluids.
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