Assembly comprising a sample collection vessel and a separation container having seal, plunger with seal-piercing point, retainer, and flexible sealing member
Inventors
Walsh, John D. • Ronsick, Christopher S. • Wilson, Mark S. • Ririe, Kirk • Hill, Ryan T.
Assignees
Biomerieux Inc • Biofire Defense LLC
Publication Number
US-11918998-B2
Publication Date
2024-03-05
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 discloses 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 separation container comprises a body defining an internal chamber with an opening at one end, a seal disposed across the opening, and a plunger movable within the chamber. The plunger is actuated to open the seal and express a portion of the sample, such as a microorganism pellet, for downstream applications.
Conventional sample preparation techniques often require multiple steps and containers, extensive user handling, and are dependent on user expertise. This can make accurate recovery of microorganism pellets challenging, especially when various types of microorganisms yield unpredictable pellet properties, thus increasing the risk of loss, contamination, or exposure to dangerous samples. The present invention addresses these deficiencies by providing an integrated container that enables centrifugation, separation, and extraction in a streamlined, contained process.
The separation container is designed such that the plunger, which may include a seal-piercing point and circumferential sealing ribs, divides the internal chamber into sub-chambers during actuation, ensuring isolated and pressurized expression of the pellet. Additional elements, such as a flexible sealing member, retainer, end cap, and rheological control members, further enhance safe, effective operation by minimizing user contact and maintaining sample purity. The invention also includes methods using this container for preparing samples suitable for downstream analysis, culture, or testing.
Claims Coverage
The patent provides several inventive features related to an integrated separation and extraction assembly using a separation container, plunger, retainer, and associated components. The independent claims collectively cover structural, functional, and operational aspects of the assembly and methods of using it.
Assembly with separation container, actuated plunger, retainer, and flexible sealing member
An assembly for sample preparation comprising: - A separation container with a body defining an internal chamber, a first opening at a first end, and a second opening at a second end. - A seal disposed across the first opening. - A plunger movably disposed at least partially inside the body and configured to be actuated to open the seal and express the portion of the sample. - A retainer attached to the body and securing the plunger in a predetermined vertical position when engaged to prevent the plunger from piercing the seal during centrifugation. - A flexible sealing member disposed at the second end of the body, at least partially covering the second opening, with the plunger configured to extend at least partially into the flexible sealing member, enabling the flexible sealing member to be compressed to actuate the plunger when the retainer is disengaged. - A sample collection vessel configured to removably and sealably engage the separation container near the first end and receive an extracted portion of the sample via the first opening. - The plunger defines a point at a first distal end to pierce the seal, allowing fluid communication between the container and the sample collection vessel for sample extraction.
The inventive features focus on an assembly integrating a separation container with a plunger and retainer system, a flexible sealing member for controlled actuation, and a sample collection vessel, all designed to achieve contained, efficient sample extraction with minimal user exposure.
Stated Advantages
Enables separation and extraction of samples, such as microorganism pellets, in fewer operations with only a single centrifugation step.
Minimizes user handling and the risk of exposure to dangerous microorganisms by integrating containment and extraction functions within a single device.
Reduces dependence on user training and skill for successful pellet recovery, offering robust, repeatable, and consistent results.
Allows for accurate, precise recovery of viable microorganism pellets suitable for downstream testing, including direct culture, AST, and identification.
Maintains sample purity and prevents contamination by fluidically isolating separated samples within the container before extraction.
Documented Applications
Preparation and extraction of microorganism pellets from clinical and non-clinical samples (e.g., blood, urine, saliva, foodstuffs, biopharmaceuticals) for downstream analysis.
Generation of viable or non-viable microbial samples suitable for culture, antibiotic susceptibility testing (AST), phenotypic identification, and other growth-based testing methods.
Preparation of pellets suitable for identification using mass spectrometry techniques such as MALDI-TOF.
Preparation of samples for analytical techniques including nucleic acid amplification, spectroscopy (Raman, FTIR), immunoassays, probe-based assays, and agglutination tests.
Processing of yeast samples and general microbial samples from blood culture bottles through lysis, centrifugation, extraction, and downstream testing.
Interested in licensing this patent?