Centrifugally separating samples in a container having a seal and containing a plunger for opening the seal
Inventors
Ronsick, Christopher S. • Wilson, Mark S. • Walsh, John D. • Ririe, Kirk • Hill, Ryan T.
Assignees
Biomerieux Inc • Biofire Defense LLC
Publication Number
US-11325117-B2
Publication Date
2022-05-10
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 and associated systems and methods for separating a sample via centrifugation and extracting a portion of the sample for use or testing. The container comprises a body with an internal chamber that receives the sample, a seal disposed across the opening to retain the sample, and a plunger movably disposed inside the chamber. The plunger can be actuated to open the seal and express the portion of the sample. The container may also include a flexible sealing member and cap to facilitate actuation of the plunger while maintaining the system sealed.
The background describes existing problems with sample preparation devices, including the need for multiple lysing, washing, decanting, and spinning steps using separate containers and specialized user handling. These deficiencies make processes dependent on user training, introduce risks of sample contamination and user exposure to dangerous microorganisms, and can damage microorganisms, rendering them unsuitable for certain downstream tests. There is a technical problem of providing a robust, repeatable process and apparatus allowing an operator to easily, safely, sterilely, and quickly prepare a biological sample for further testing.
Embodiments of the present invention provide solutions by enabling the separation of microorganisms from samples with fewer operations, specifically allowing separation and extraction with a single centrifugation step. The separation container allows for the safe recovery of sample pellets without additional washing steps or user exposure, keeping the recovered microorganism viable for downstream testing such as culturing, antibiotic susceptibility testing (AST), and molecular analysis. The container optionally incorporates a rheological control member to prevent mixing of the sample and density cushion prior to centrifugation, and may engage a sample collecting vessel for downstream processing.
Claims Coverage
The patent contains several inventive features as set forth in the independent claims, particularly focusing on the structure and methods relating to the separation container, the plunger and retainer assembly, and the flexible sealing member.
Separation container with body, seal, and plunger actuated via a flexible sealing member
A method of using a separation container comprising: - A body defining an internal chamber with a first opening at a first end and a second opening at a second end. - A seal disposed across the first opening to seal the body. - A plunger movably disposed at least partially inside the internal chamber. - A flexible sealing member at least partially covering the second opening, wherein at least a portion of the plunger extends at least partially into the flexible sealing member. The method includes: 1. Disposing a sample in the internal chamber. 2. Centrifuging the separation container, holding the plunger axially by a retainer during centrifugation. 3. After centrifugation, manipulating the flexible sealing member to unlock the plunger from the retainer and depressing the flexible sealing member to actuate the plunger and open the seal to extract a portion of the sample.
The patent claims protection over a sample separation container system utilizing a body, seal, plunger, a flexible sealing member, and a retainer, allowing actuation of the plunger via manipulation of the flexible sealing member after centrifugation.
Stated Advantages
Enables separation and extraction of microorganisms from a sample in fewer steps, requiring only a single centrifugation step.
Reduces user handling and minimizes exposure to dangerous microorganisms by allowing extraction without opening the container.
Allows recovery of microorganism pellets without contaminating the sample or losing the pellet, improving consistency across users.
Preserves viability of recovered microorganisms for downstream applications such as AST, culturing, or other growth-based testing methods.
The container structure allows an untrained user to recover a pellet with minimal training and effort, improving ease of use.
Prevents mixing of sample and density cushion during loading, maintaining separation efficacy and sample purity.
Documented Applications
Preparation of clinical and non-clinical samples for biological testing, including blood, serum, plasma, joint fluid, urine, nasal samples, cerebrospinal fluid, tissue homogenates, bone marrow, foodstuffs, water, cell cultures, biopharmaceuticals, and cosmetics.
Downstream testing of recovered pellets for viable culture, antibiotic susceptibility testing (AST), phenotypic identification methods, and other growth-based downstream testing methods.
Identification of microorganisms by mass spectrometry techniques such as MALDI-TOF.
Use in analytical techniques including nucleic acid amplification, spectroscopy (Raman, FTIR), immunoassay, probe-based assays, and agglutination tests.
Processing of yeast samples including lysis, centrifugation, washing, and downstream mass spectrometry-based identification.
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