# US 12,766,502 B2 · Device and method for testing serum and plasma separated from blood cells in whole blood samples > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,766,502 B2 - Document ID: US12766502B2 - Status: Granted - Kind: B2 - Application number: 18/786,356 - Filed: 2024-07-26 - Published: 2024-11-21 - Granted: 2026-10-20 - Earliest claimed: 2015-12-11 - Assignees: Babson Diagnostics, Inc. - Applicants: Babson Diagnostics, Inc. - Inventors: Eric Olson - Web page: https://patentgrep.com/patent/US12766502B2 ## CPC - B01L 3/50215: {using a float to separate phases} - B01D 21/26: Separation of sediment aided by centrifugal force {or centripetal force}(centrifuges B04B; cyclones B04C) - B01L 3/5021: {Test tubes specially adapted for centrifugation purposes} - G01N 21/07: Centrifugal type cuvettes (G01N21/09 takes precedence) - A61B 5/15003: {for venous or arterial blood} - A61B 5/154: {Devices} using pre-evacuated means - B01L 2300/042: Caps; Plugs - B01L 2300/044: pierceable, e.g. films, membranes - B01L 2300/047: Additional chamber, reservoir - B01L 2300/0832: cylindrical, tube shaped - B01L: CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE - B01D: SEPARATION (separating solids from solids by wet methods B03B, B03D; by pneumatic jigs or tables B03B; by other dry methods B07; magnetic or electrostatic separation of solid materials from solid materials or fluids, separation by high-voltage electric fields B03C; centrifuges, vortex apparatus B04; presses per se for squeezing-out liquid from liquid-containing material B30B9/02; treatment of water C02F, e.g. softening by ion-exchange C02F1/42; {arrangements of air intake cleaners in gas turbine plants F02C7/05} ; arrangements or mounting of filters in air-conditioning, air-humidification or ventilation F24F13/28) - 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) - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract A device and method for separating serum or plasma from blood cells in a whole blood specimen. The present invention uses a cap with a reservoir, such that blood cells are packed into the cap when the specimen container is centrifuged. When the cap is removed, the blood cells are also removed, and the serum or plasma is left in the specimen tube where it can be readily extracted by a pipette which is able to reach all the way to the bottom of the specimen tube minimizing the dead volume. ## Claims ### Claim 1 A specimen container for containing a whole blood sample, the specimen container including: a specimen tube having a closed end, an open end, and defining an inner volume therebetween, the specimen tube configured to receive the blood sample through the open end of the specimen tube; and a cap defining a reservoir having a maximum cross-sectional area greater than a maximum cross-sectional area of the inner volume of the specimen tube, the cap configured to be rotatably coupled to the specimen tube to enclose the inner volume and place the inner volume in fluid communication with the reservoir, the specimen container configured to be centrifuged with the cap further away from an axis of centrifugation than the closed end of the specimen tube such that blood cells in the blood sample migrate into the reservoir and remain in the reservoir after the specimen container is centrifuged, the cap, with the blood cells disposed within the reservoir, being rotatably removable from the specimen tube to expose the open end of the specimen tube such that serum or plasma from the blood sample can be withdrawn through the open end of the specimen tube. ### Claim 2 (depends on 1) The specimen container of claim 1, wherein the reservoir extends into the specimen tube when the cap is coupled to the specimen tube. ### Claim 3 (depends on 2) The specimen container of claim 2, wherein the specimen tube includes an internal threading, and the cap includes a threaded connection configured to be coupled to the internal threading. ### Claim 4 (depends on 1) The specimen container of claim 1, wherein the specimen tube is configured to receive the blood sample through the open end of the specimen tube when the cap is coupled to the specimen tube. ### Claim 5 (depends on 4) The specimen container of claim 4, wherein the cap has a closed end including a pierceable material, the pierceable material configured such that a cannula can be inserted through the closed end of the cap. ### Claim 6 (depends on 1) The specimen container of claim 1, wherein the inner volume of the specimen tube is about 0.1 mL to about 2.0 mL. ### Claim 7 (depends on 1) The specimen container of claim 1, wherein the closed end of the specimen tube is at least one of round or conical. ### Claim 8 (depends on 1) The specimen container of claim 1, wherein a volume of the reservoir is greater than or equal to the inner volume of the specimen tube. ### Claim 9 (depends on 1) The specimen container of claim 1, further comprising: a separator disposed in at least one of the inner volume or the reservoir, the separator configured to migrate into the reservoir and remain in the reservoir after the specimen container is centrifuged. ### Claim 10 (depends on 9) The specimen container of claim 9, wherein the separator includes at least one of a thixotropic gel, a mechanical separator, or a filter-based separator. ### Claim 11 (depends on 1) The specimen container of claim 1, wherein the specimen tube is cylindrical. ### Claim 12 (depends on 1) The specimen container of claim 1, further comprising: a clot activator including silica disposed within the volume of the specimen tube. ### Claim 13 (depends on 1) The specimen container of claim 1, further comprising: an anticoagulant disposed within the volume of the specimen tube, the anticoagulant including at least one of lithium heparin or ethylenediaminetetraacetic acid (EDTA). ### Claim 14 A specimen container for containing a whole blood sample, the specimen container comprising: a cylindrical specimen tube having a closed end, an open end, and defining an inner volume therebetween, the specimen tube configured to receive the blood sample through the open end of the specimen tube; and a monolithic cap defining a reservoir, the monolithic cap configured to accommodate delivery of the blood sample therethrough when the monolithic cap is coupled to the specimen and then become sealed, the monolithic cap configured to be removably coupled to the specimen tube to place the inner volume in fluid communication with the reservoir, the specimen container configured to be centrifuged with the monolithic cap further away from an axis of centrifugation than the closed end of the specimen tube such that blood cells in the blood sample migrate into the reservoir and remain in the reservoir after the specimen container is centrifuged, the monolithic cap, with the blood cells disposed within the reservoir, being removable from the specimen tube to expose the open end of the specimen tube such that serum or plasma from the blood sample can be withdrawn through the open end of the specimen tube, the monolithic cap further configured to be recoupled to the specimen tube. ### Claim 15 (depends on 14) The specimen container of claim 14, wherein the closed end of the monolithic cap includes a pierceable material configured such that a cannula can be inserted through the closed end of the monolithic cap. ### Claim 16 (depends on 14) The specimen container of claim 14, wherein the inner volume of the specimen tube is about 0.1 mL to about 2.0 mL. ### Claim 17 (depends on 14) The specimen container of claim 14, wherein the closed end of the specimen tube is at least one of round or conical. ### Claim 18 (depends on 14) The specimen container of claim 14, wherein a volume of the reservoir is greater than or equal to the inner volume of the specimen tube. ### Claim 19 (depends on 14) The specimen container of claim 14, wherein the reservoir extends into the specimen tube when the monolithic cap is coupled to the specimen tube. ### Claim 20 (depends on 14) The specimen container of claim 14, wherein the specimen tube is rotatably coupled to the monolithic cap. ### Claim 21 (depends on 14) The specimen container of claim 14, further comprising: a separator disposed within at least one of the inner volume or the reservoir, the separator configured to migrate into the reservoir and remain in the reservoir after the specimen container is centrifuged. ### Claim 22 (depends on 21) The specimen container of claim 21, wherein the separator includes at least one of a thixotropic gel, a mechanical separator, or a filter-based separator. ### Claim 23 A specimen container for containing a whole blood sample, the specimen container including: a cylindrical specimen tube having a closed end, an open end, and defining an inner volume therebetween, the closed end being at least one of round or conical, the open end being the only opening of the specimen container tube, the specimen tube configured to receive the blood sample through the open end of the specimen tube, the specimen tube including a coupling feature disposed on an outside surface of the specimen tube; and a cap defining a reservoir having a maximum cross-sectional area greater than a maximum cross-sectional area of the inner volume of the specimen tube, the cap including a coupling feature disposed on an inside surface of the cap and configured to be rotatably coupled to the coupling feature of the specimen tube to enclose the inner volume and place the inner volume in fluid communication with the reservoir, the cap configured to accommodate delivery or withdrawal of the blood sample therethrough when the cap is coupled to the specimen tube and then become sealed. ### Claim 24 (depends on 23) The specimen container of claim 23 wherein the cap has a closed end including a pierceable material, the pierceable material configured such that a cannula can be inserted through the closed end of the cap. ### Claim 25 (depends on 23) The specimen container of claim 23, wherein the inner volume of the specimen tube is about 0.1 mL to about 2.0 mL. ### Claim 26 (depends on 23) The specimen container of claim 23, wherein a volume of the reservoir is greater than or equal to the inner volume of the specimen tube. ### Claim 27 (depends on 23) The specimen container of claim 23, wherein a portion of the cap circumferentially surrounds a portion of the specimen tube when the cap is coupled to the specimen tube. ### Claim 28 (depends on 23) The specimen container of claim 23, further comprising an anticoagulant disposed within the volume of the specimen tube, the anticoagulant including at least one of lithium heparin or ethylenediaminetetraacetic acid (EDTA).