# US 10,244,973 B2 · Systems, devices, and methods for bodily fluid sample transport > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,244,973 B2 - Document ID: US10244973B2 - Status: Granted - Kind: B2 - Application number: 15/160,196 - Filed: 2016-05-20 - Published: 2017-01-26 - Granted: 2019-04-02 - Earliest claimed: 2012-12-05 - Assignees: Theranos IP Company, LLC - Applicants: Theranos, Inc. - Inventors: Elizabeth A. Holmes; Clarissa Lui; Michael Chen; Daniel Young - Web page: https://patentgrep.com/patent/US10244973B2 ## CPC - A61B 5/150022: {for capillary blood or interstitial fluid} - A61B 5/1422: {provided with indicating means, e.g. for vein entry} - A61B 5/1438: {using pre-evacuated means} - A61B 5/150305: {Packages specially adapted for piercing devices or blood sampling devices} - A61B 5/150343: {Collection vessels for collecting blood samples from the skin surface, e.g. test tubes, cuvettes (sampling from within body cavities A61B5/150015, A61B5/150045)} - A61B 5/150755: {Blood sample preparation for further analysis, e.g. by separating blood components or by mixing} - A61B 5/150786: {Optical identification systems, e.g. bar codes, colour codes} - A61B 5/15105: {Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices} - A61B 5/1545: {comprising means for indicating vein or arterial entry} - B01L 3/5082: {Test tubes per se} - B01L 9/06: Test-tube stands; Test-tube holders - B65D 25/108: {Devices, e.g. plates, presenting apertures through which the articles project} - B65D 43/16: hinged for upward or downward movement - B65D 81/18: providing specific environment for contents, e.g. temperature above or below ambient (with thermal insulation B65D81/38) - A61B 5/15003: {for venous or arterial blood} - A61B 5/150099: {by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes} - A61B 5/150213: {Venting means} - A61B 5/150389: {Hollow piercing elements, e.g. canulas, needles, for piercing the skin} - A61B 5/150473: {Double-ended needles, e.g. used with pre-evacuated sampling tubes (hollow piercing element tip design A61B5/150396)} - A61B 5/150732: {Needle holders, for instance for holding the needle by the hub, used for example with double-ended needle and pre-evacuated tube} - A61B 5/15074: {Needle sets comprising wings, e.g. butterfly type, for ease of handling} - B01L 2200/025: Align devices or objects to ensure defined positions relative to each other - B01L 2200/185: Long distance transport, e.g. mailing - B01L 2300/021: Identification, e.g. bar codes - B01L 2300/12: Specific details about materials - B01L 2300/1822: using Peltier elements - B01L 2300/1855: using phase changes in a medium - B01L 2300/1894: Cooling means; Cryo cooling - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - B01L: CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE - B65D: CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES ## Abstract Bodily fluid sample transport systems, devices, and method are provided. In at least one embodiment described herein, methods are provided for the physical transport of small volumes of bodily fluid in liquid form from one location to another location. By way of nonlimiting example, the samples are collected in liquid form at a collection site, transported in liquid form, and arrive at an analysis site in liquid form. In many embodiments, the liquid form during transport is not held in a porous matrix, wicking material, webbing, or similar material that prevents sample for being extracted in liquid form at the destination site. In one embodiment, small volume of sample in each sample vessel is in the range of about 1 ml to about 1 microliter. ## Claims ### Claim 1 A method comprising: collecting a bodily fluid sample on a surface of a subject, wherein the collected sample is stored in one or more sample vessels each having an information storage unit on a bottom surface of each of the sample vessels; providing a transport container to house at least two or more sample vessels, wherein the vessels are arranged in a two-dimensional array configuration in the transport container and wherein the transport container further comprises a tray sized to fit inside the transport container and hold the sample vessels therein in the two-dimensional array configuration; arranging to have the sample vessels shipped in the transport container from a first location to a second location, wherein each of the sample vessels arrives at the second location holding a majority of its bodily fluid sample in a non-wicked, non-matrixed form that is removable from the sample vessels in liquid form and wherein the amount of sample in each of the sample vessels does not exceed about 2 ml; removing the tray from the transport container; and scanning information storage units on substantially all of the sample vessels, wherein the scanning occurs while the sample vessels remain in the tray in the two-dimensional array configuration at the second location; wherein the sample vessels held in slots in the tray, wherein said slots have open bottoms that allow said information storage units to be scanned from below after the tray is removed from the transport container. ### Claim 2 (depends on 1) The method of claim 1 wherein collecting comprises making at least one puncture on the subject to release the bodily fluid, wherein the puncture is not a venipuncture. ### Claim 3 (depends on 1) The method of claim 1 wherein collecting comprises using at least one lancet to make at least one puncture on the subject. ### Claim 4 (depends on 3) The method of claim 3 wherein the puncture is formed by pricking skin on a forearm of the subject. ### Claim 5 (depends on 1) The method of claim 1 wherein the sample vessel has an interior that is initially at sub-atmospheric pressure prior to drawing sample into the interior of the sample vessel. ### Claim 6 (depends on 5) The method of claim 5 wherein the sub-atmospheric pressure is selected to provide sufficient force to draw a desired volume of sample into the sample vessel. ### Claim 7 (depends on 1) The method of claim 1 wherein the transport container contains at least five or more sample vessels. ### Claim 8 (depends on 1) The method of claim 1 wherein the transport container is used to simultaneously ship bodily fluid samples from a plurality of different subjects. ### Claim 9 (depends on 1) The method of claim 1 wherein information associated with each of the sample vessels determines what tests will be run on the bodily fluid sample therein. ### Claim 10 (depends on 1) The method of claim 1 further comprising using a cooled tray to hold the sample vessels in a temperature controlled storage chamber prior to loading the vessels into the container and the same cooled tray is used to hold the sample vessels in the transport container, wherein the samples are placed into transport container with the cooled tray. ### Claim 11 (depends on 1) The method of claim 1 wherein sample vessels are arranged such that there are at least two vessels in each container with bodily sample fluid from the same subject, wherein at least a first sample includes a first anticoagulant and a second sample includes a second anticoagulant in the matrix. ### Claim 12 (depends on 1) The method of claim 1 the fluid sample comprises capillary blood for use in CLIA compliant laboratory testing. ### Claim 13 (depends on 1) The method of claim 1 further comprising using a housing providing a controlled-thermal-profile and high-heat-of-fusion material providing at least one cooling surface facing the sample vessels. ### Claim 14 (depends on 13) The method of claim 13 wherein the controlled-thermal-profile, high-heat-of-fusion material is embedded in material used to form the container. ### Claim 15 (depends on 1) The method of claim 1 further comprising scanning an information storage unit on each sample at a transport container receiving site and automatically placing the container into a cartridge. ### Claim 16 (depends on 1) The method of claim 1 further comprising using the same tray to hold sample vessels in an array configuration when in a refrigeration device prior to transport and when in the transport container. ### Claim 17 (depends on 16) The method of claim 16 wherein the tray comprises a plurality of slots having a shape to hold sample vessels holders in a preferential orientation, wherein the sample vessels cannot be inserted in a different orientation. ### Claim 18 (depends on 10) The method of claim 10 further comprising using a single step to load a plurality of sample vessels from cooled storage into the transport container while maintaining a desired sample-vessel-to-sample-vessel orientation during the loading step. ### Claim 19 (depends on 1) The method of claim 1 wherein the transport container has a first surface configured to define a preferential thermally-conductive pathway to a controlled-thermal-profile, high-heat-of-fusion material in the transport container.