Systems, devices, and methods for bodily fluid sample transport

• US 10,244,973 B2
• Filed: 05/20/2016
• Issued: 04/02/2019
• Est. Priority Date: 12/05/2012
• Status: Active Grant

• Current Assignee: Labrador Diagnostics LLC (SoftBank Group Corp.)
• Original Assignee: Theranos IP Company, LLC
• Inventors: Holmes, Elizabeth A., Lui, Clarissa, Chen, Michael, Young, Daniel
• Primary Examiner(s): Hindenburg, Max
• Application Number:
  US15/160,196
• Publication Number:
  US 20170020425A1
• Time in Patent Office: 1,047 Days
• CPC Class Codes: A61B 5/1422 provided with indicating means, e.g. for vein entry
• CPC Class Codes: A61B 5/1438 using pre-evacuated means
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150099 by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150305 Packages specially adapted for piercing devices or blood sampling devices kits for diabetes A61M5/003; packaging in general B65D
• CPC Class Codes: 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
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150473 Double-ended needles, e.g. used with pre-evacuated sampling tubes hollow piercing element tip design A61B5/150396; needle sets for catheters A61M25/06; needles for bringing media into the body A61M5/32
• CPC Class Codes: 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,
• CPC Class Codes: A61B 5/15074 Needle sets comprising wings, e.g. butterfly type, for ease of handling
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/150786 Optical identification systems, e.g. bar codes, colour codes
• CPC Class Codes: A61B 5/15105 Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
• CPC Class Codes: A61B 5/1545 comprising means for indicating vein or arterial entry
• CPC Class Codes: B01L 2200/025 Align devices or objects to ensure defined positions relative to each other
• CPC Class Codes: B01L 2200/185 Long distance transport, e.g. mailing
• CPC Class Codes: B01L 2300/021 Identification, e.g. bar codes
• CPC Class Codes: B01L 2300/12 Specific details about materials
• CPC Class Codes: B01L 2300/1822 : using Peltier elements
• CPC Class Codes: B01L 2300/1855 : using phase changes in a medium
• CPC Class Codes: B01L 2300/1894 : Cooling means; Cryo cooling
• CPC Class Codes: B01L 3/5082 : Test tubes per se
• CPC Class Codes: B01L 9/06 : Test-tube stands; Test-tube holders
• CPC Class Codes: B65D 25/108 : Devices, e.g. plates, presenting apertures through which the articles project
• CPC Class Codes: B65D 43/16 : hinged for upward or downward movement cigar or cigarette receptacles A24F15/00; suitcases, ètuis A45C; casings for cosmetic substances with hinged covers A45D40/22; toolboxes B25H3/02; hinges of door or similar type E05D ; boxes for switchboards with hinged covers H02B1/066
• CPC Class Codes: B65D 81/18 : providing specific environment for contents, e.g. temperature above or below ambient with thermal insulation B65D81/38; ice-boxes with cooling means F25D

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

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.

2. 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.

3. The method of claim 1 wherein collecting comprises using at least one lancet to make at least one puncture on the subject.

4. The method of claim 3 wherein the puncture is formed by pricking skin on a forearm of the subject.

5. 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.

6. 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.

7. The method of claim 1 wherein the transport container contains at least five or more sample vessels.

8. The method of claim 1 wherein the transport container is used to simultaneously ship bodily fluid samples from a plurality of different subjects.

9. 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.

10. 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.

11. 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.

12. The method of claim 1 the fluid sample comprises capillary blood for use in CLIA compliant laboratory testing.

13. 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.

14. The method of claim 13 wherein the controlled-thermal-profile, high-heat-of-fusion material is embedded in material used to form the container.

15. 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.

16. 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.

17. 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.

18. 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.

19. 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.