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-11850584-B2
Publication Date
2023-12-26
Expiration Date
2038-07-26
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
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 assemblies and methods for extracting a portion of a sample for use or testing. The container consists of a body defining an internal chamber with an opening, a seal across the opening to prevent sample escape, and a plunger movably disposed at least partially inside the chamber. The plunger is actuated to open the seal and express a portion of the sample, which has been separated via centrifugation, for downstream use or testing.
Traditional sample preparation requires multiple steps such as lysing, washing, decanting, and centrifuging, often necessitating various containers and substantial manual handling. These conventional systems are heavily dependent on user training and precision, leading to risks of contamination, sample loss, or exposure when handling dangerous microorganisms. There is also a need to minimize human interaction with pathogenic samples while achieving accurate and reproducible results, especially when microorganism pellet properties vary widely.
The developed separation container addresses these issues by facilitating separation of microorganisms from samples with a single centrifugation step and providing a plunger-based extraction system that allows for safe, consistent, and aseptic sample recovery. The design may include additional features such as a flexible sealing member, rheological control member to prevent mixing of sample and density cushion, and sample collecting vessel for immediate downstream processing. This arrangement streamlines sample preparation, reduces handling, and maintains the integrity and viability of the recovered sample for various types of downstream testing.
Claims Coverage
The independent claim defines one main inventive feature concerning the interaction between a plunger and a retainer within a separation container for precise sample processing.
Rotationally engaged plunger and retainer assembly within a separation container
A centrifugable assembly includes: - A plunger configured to be disposed at least partially within a separation container, defining a longitudinal axis. - A body of the separation container comprising a retainer that engages the plunger by rotation about the longitudinal axis. **Key functionality:** - When the retainer and plunger are engaged, the retainer maintains the plunger at a predetermined position, prohibiting movement of the plunger along the longitudinal axis. - When the retainer and plunger are disengaged (via rotation), the plunger is freely movable along the longitudinal axis, enabling actuation (e.g., opening a seal and expressing the sample). This engagement-disengagement mechanism is achieved by rotational alignment and cooperation between corresponding support/locking members on the plunger and retainer. The retainer can be integrated or separately inserted (including press fit) into the container body.
The claims protect an assembly that utilizes rotational engagement and disengagement between a plunger and an internal retainer within a separation container, ensuring secure retention during centrifugation and controlled axial movement for sample extraction.
Stated Advantages
Allows an untrained user to recover a pellet with minimal training and effort and with greater consistency than prior devices.
Enables separation and testing of the sample without user handling of the microorganism and without destroying microorganism viability, permitting viable downstream testing.
Reduces the number of handling steps, operations, and required equipment for sample preparation compared to traditional methods.
Improves user safety by minimizing the risk of exposure to dangerous microorganisms during recovery and handling.
Provides a repeatable, robust process that can be performed quickly, safely, and in a sterile manner.
Documented Applications
Processing and analyzing clinical specimens (e.g., blood, serum, plasma, platelets, joint fluid, urine, nasal samples, semen, saliva, feces, cerebrospinal fluid, gastric contents, vaginal secretions, tissue homogenates, bone marrow aspirates, bone homogenates, sputum, aspirates, swabs and swab rinsates, other body fluids) for microorganism separation.
Analysis and processing of non-clinical samples including foodstuffs (e.g., milk, meat products, vegetables, fruits, beverages, puddings), cell cultures, biopharmaceuticals, cosmetics, water, and parenteral fluids for microbial contamination.
Preparation of viable pellets suitable for downstream applications such as antibiotic susceptibility testing (AST), culture, phenotypic identification methods, and other growth-based downstream testing methods.
Sample preparation for identification by mass spectrometry (including MALDI-TOF) and techniques such as nucleic acid amplification, spectroscopy (Raman, FTIR), immunoassay techniques, probe-based assays, and agglutination tests.
Processing of yeast samples using lysis, centrifugation, expression, resuspension, and washing for downstream testing (including MALDI-TOF).
Interested in licensing this patent?