# US 11,305,273 B2 · Isolation tube with a rheological control member and a plunger > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,305,273 B2 - Document ID: US11305273B2 - Status: Granted - Kind: B2 - Application number: 16/046,270 - Filed: 2018-07-26 - Published: 2019-01-31 - Granted: 2022-04-19 - Earliest claimed: 2017-07-27 - Assignees: Biomerieux; BioFire Defense, LLC - Applicants: bioMerieux, Inc.; BioFire Defense, LLC - Inventors: John D. Walsh; Christopher S. Ronsick; Mark S. Wilson; Kirk Ririe; Ryan T. Hill - Web page: https://patentgrep.com/patent/US11305273B2 ## CPC - B01L 3/50215: {using a float to separate phases} - B01L 3/0296: {from piercable tubing, e.g. in extracorporeal blood sampling} - B01L 3/5021: {Test tubes specially adapted for centrifugation purposes} - B01L 3/5082: {Test tubes per se} - B01L 3/50825: {Closing or opening means, corks, bungs} - B04B 5/0414: {comprising test tubes} - C12M 33/02: {by impregnation, e.g. using swabs or loops (fluid transport using swabs B01L3/5029)} - C12M 33/10: {by centrifugation (centrifuges in general B04B); Cyclones (cyclones in general B04C)} - C12M 45/05: {by centrifugation (centrifuges in general B04B)} - C12Q 1/24: Methods of sampling, or inoculating or spreading a sample; Methods of physically isolating an intact microorganisms - G01N 1/2035: {by deviating part of a fluid stream, e.g. by drawing-off or tapping} - G01N 1/4077: {by other techniques involving separation of suspended solids} - B01L 2200/02: Adapting objects or devices to another - B01L 2200/0652: Sorting or classification of particles or molecules - B01L 2200/0684: Venting, avoiding backpressure, avoid gas bubbles - B01L 2200/0689: Sealing - B01L 2300/042: Caps; Plugs - B01L 2300/044: pierceable, e.g. films, membranes - B01L 2300/0672: Integrated piercing tool - B01L 2300/0681: Filter - B01L 2300/0832: cylindrical, tube shaped - B01L 2300/0848: Specific forms of parts of containers - B01L 2300/123: Flexible; Elastomeric - B01L 2400/0409: centrifugal forces - B01L 2400/0478: pistons - B01L 2400/0633: with moving parts - B01L 2400/0683: mechanically breaking a wall or membrane within a channel or chamber - B04B 2005/0435: {with adapters for centrifuge tubes or bags} - B04B 2011/046: {Loading, unloading, manipulating sample containers} - G01N 2001/4083: {sedimentation} - B01L: CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE - B04B: CENTRIFUGES (high-speed drum mills B02C19/11; domestic spin driers D06F; analysing, measuring or monitoring physical or chemical properties of samples during centrifuging, see the relevant subclasses for these procedures, e.g. G01N) - C12M: APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; {APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS} - C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES - G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q) ## 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. ## Claims ### Claim 1 A separation container for extracting a portion of a sample for use or testing, the separation container comprising: a body defining an internal chamber, wherein the body defines an opening, and wherein the body is configured to receive the sample within the internal chamber; a seal disposed across the opening, such that the seal is configured to seal the opening of the body; a plunger movably disposed at least partially inside the internal chamber, wherein the plunger defines a point at a first distal end of a longitudinal member of the plunger, and wherein the point is configured to pierce the seal to allow fluid communication between the internal chamber and an area outside the body via the opening, and wherein the plunger is configured to be actuated to open the seal and express the portion of the sample; and a rheological control member disposed in the internal chamber, wherein the rheological control member has a bore through which the plunger is disposed, the bore having a diameter greater than an outer diameter of the plunger such that the rheological control member is configured to slide relative to the plunger and the body. ### Claim 2 (depends on 1) The separation container of claim 1, wherein the body defines an axis extending from the opening to a second end of the body, wherein a longitudinal member of the plunger is disposed on the axis, wherein the internal chamber defines a diameter radial to the axis, and wherein the diameter narrows from a collection diameter to a pellet diameter in a direction extending axially from the second end to the opening. ### Claim 3 (depends on 2) The separation container of claim 2, wherein at least a portion of the plunger is configured to sealingly engage the body at a portion of the body corresponding to the pellet diameter. ### Claim 4 (depends on 3) The separation container of claim 3, wherein a longitudinal axis of the longitudinal member of the plunger is coincident with the axis of the body, wherein the at least the portion of the plunger defines a plunger diameter radial to the longitudinal axis of the longitudinal member, and wherein the plunger diameter is greater than or equal to the pellet diameter. ### Claim 5 (depends on 4) The separation container of claim 4, wherein the at least the portion of the plunger comprises a plunger seal disposed circumferentially about the longitudinal member of the plunger, wherein the plunger seal is configured to engage the body at the portion of the body corresponding to the pellet diameter. ### Claim 6 (depends on 1) The separation container of claim 1, wherein the plunger is configured to allow the portion of the sample to pass by the plunger from a second end towards the opening during centrifugation, and wherein the plunger is configured to prevent a remaining part of the sample from exiting the opening in an instance in which the plunger is actuated, such that the plunger is configured to divide the internal chamber into two sub-chambers. ### Claim 7 (depends on 6) The separation container of claim 6, wherein the plunger is buoyant in water or a density cushion material. ### Claim 8 (depends on 1) The separation container of claim 1, further comprising a sample collecting vessel configured to engage the body, wherein the sample collecting vessel is configured to surround the opening, such that the sample collecting vessel is configured to collect the portion of the sample passing through the seal. ### Claim 9 (depends on 1) The separation container of claim 1, wherein the body comprises a wall at least partially bounding the internal chamber, and wherein the rheological control member is annularly disposed between the plunger and the wall. ### Claim 10 (depends on 9) The separation container of claim 9, wherein the wall comprises a first annular shoulder at which a diameter of the internal chamber changes from a first diameter at a first axial position in a static state to a second diameter at a second axial position in the static state, and wherein the first annular shoulder is configured to engage the rheological control member. ### Claim 11 (depends on 9) The separation container of claim 9, wherein the body defines a second end and an axis of the body extending from the opening to the second end, wherein the internal chamber has a variable diameter perpendicular to the axis, wherein the wall is at least partially flexible such that the variable diameter of the internal chamber is a first diameter in a static state and the variable diameter of the internal chamber expands to a second diameter during centrifugation, wherein the rheological control member has an outermost diameter radial to the axis of the body, wherein the outermost diameter of the rheological control member is greater than the first diameter, and wherein the second diameter is greater than the outermost diameter of the rheological control member. ### Claim 12 (depends on 10) The separation container of claim 10, wherein the body comprises a collection region, the collection region having a diameter corresponding to the variable diameter of the internal chamber, wherein the body comprises a widened region having a greater diameter than the diameter of the collection region, and wherein the greater diameter of the widened region is greater than the outermost diameter of the rheological control member. ### Claim 13 (depends on 10) The separation container of claim 10, wherein the rheological control member comprises a second annular shoulder comprising a wide side defining an outermost diameter of the rheological control member and a narrow side defining a narrower diameter of the rheological control member than the outermost diameter of the rheological control member. ### Claim 14 (depends on 1) The separation container of claim 1, further comprising a gasket disposed circumferentially about the plunger, and wherein the gasket is configured to seal a central opening between the bore of the rheological control member and the plunger. ### Claim 15 (depends on 1) The separation container of claim 1, wherein the rheological control member comprises one or more ribs and the one or more ribs are configured to engage a wall of the body. ### Claim 16 A method for preparing samples for downstream use or testing, the method comprising: disposing a sample into a separation container, wherein the separation container comprises: a body defining an internal chamber, wherein the body defines an opening; a seal disposed across the opening, such that the seal is configured to seal the opening of the body; a plunger movably disposed at least partially inside the internal chamber, wherein the plunger defines a point at a first distal end of a longitudinal member of the plunger, wherein the point is configured to pierce the seal to allow fluid communication between the internal chamber and an area outside the body via the opening, and wherein the plunger is configured to be actuated to open the seal; and a rheological control member disposed in the internal chamber, wherein the rheological control member has a bore through which the plunger is disposed, the bore having a diameter greater than an outer diameter of the plunger such that the rheological control member is configured to slide relative to the plunger and the body; centrifuging the separation container to create a pellet from a portion of the sample within the internal chamber; and expressing the pellet from the opening in the body by depressing the plunger. ### Claim 17 (depends on 16) The method for preparing samples of claim 16, wherein centrifuging the separation container to create the pellet comprises allowing the portion of the sample to collect at a first end of the body, wherein the opening is defined at the first end. ### Claim 18 (depends on 16) The method for preparing samples of claim 16, wherein expressing the pellet comprises depressing the plunger into sealing engagement with a portion of the body to create pressure between the plunger and the seal, and expelling the pellet from the opening under the pressure by opening the seal. ### Claim 19 (depends on 16) The method for preparing samples of claim 16, further comprising: creating the sample by lysing a raw sample. ### Claim 20 (depends on 16) The method for preparing samples of claim 16, further comprising: creating the sample by culturing a raw sample. ### Claim 21 (depends on 16) The method for preparing samples of claim 16, further comprising: expressing the pellet into a sample collecting vessel. ### Claim 22 (depends on 21) The method for preparing samples of claim 21, wherein the sample collecting vessel comprises a culture medium configured to culture organisms present in the pellet. ### Claim 23 (depends on 16) The method for preparing samples of claim 16, wherein the pellet comprises viable portions of the sample suitable for antibiotic susceptibility testing (AST). ### Claim 24 (depends on 16) The method for preparing samples of claim 16, wherein the pellet comprises viable portions of the sample suitable for a culture step. ### Claim 25 (depends on 16) The method for preparing samples of claim 16, wherein the pellet comprises viable portions of the sample suitable for phenotypic identification methods and/or other growth-based downstream testing methods. ### Claim 26 (depends on 16) The method for preparing samples of claim 16, wherein the pellet comprises portions of the sample suitable for identification by mass spectrometry. ### Claim 27 (depends on 16) The method for preparing samples of claim 16, further comprising analyzing the pellet using an analytical technique selected from a group consisting of a nucleic acid amplification technique, a spectroscopy technique, an immunoassay technique, a probe-based assay, and an agglutination test. ### Claim 28 A separation container comprising: a body defining an internal chamber, wherein the body defines an opening, and wherein the body is configured to receive a sample within the internal chamber; a plunger movably disposed at least partially inside the internal chamber; a rheological control member disposed in the internal chamber, wherein the rheological control member has a bore through which the plunger is disposed, the bore having a diameter greater than an outer diameter of the plunger such that the rheological control member is configured to slide relative to the plunger and the body, and wherein the rheological control member is interference fit within the body at a fixed position during filling and wherein the body is configured to flex in a radially outward direction during centrifugation to release the interference fit of the rheological control member to float on the sample during centrifugation; means for sealing the opening of the body; and means for opening the means for sealing and expressing a portion of the sample.