Systems, devices, and methods for bodily fluid sample collection, transport, and handling

• US 10,248,765 B1
• Filed: 06/11/2015
• 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, Lath, Adrit, Morrison, Zachary, Argyres, Brian, Westrick, William
• Primary Examiner(s): Hindenburg, Max
• Application Number:
  US14/737,412
• Time in Patent Office: 1,391 Days
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150251 Collection chamber divided into at least two compartments, e.g. for division of samples injection syringes having more than one chamber A61M5/19; syringes for injection of two or more media A61M5/2448, A61M5/284; sample preparation for further analysis A61B5/150755
• 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 5/150351 Caps, stoppers or lids for sealing or closing a blood collection vessel or container, e.g. a test-tube or syringe barrel caps for bottles or containers in general B65D41/00
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150503 Single-ended needles 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 5/150992 Blood sampling from a fluid line external to a patient, such as a catheter line, combined with an infusion line; blood sampling from indwelling needle sets, e.g. sealable ports, luer couplings, valves tubing connectors and couplings A61M39/00
• 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 5/15109 Fully automatically triggered, i.e. the triggering does not require a deliberate action by the user, e.g. by contact with the patient's skin
• CPC Class Codes: A61B 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable
• CPC Class Codes: B01L 2200/16 Reagents, handling or storing thereof
• CPC Class Codes: B01L 2200/185 Long distance transport, e.g. mailing
• CPC Class Codes: B01L 2300/022 : Transponder chips
• CPC Class Codes: B01L 2300/024 : Storing results with means integrated into the container
• CPC Class Codes: B01L 2300/185 : using a liquid as fluid
• CPC Class Codes: B01L 2300/1883 : using thermal insulation
• CPC Class Codes: B01L 3/502715 : characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: B01L 7/04 : Heat insulating devices, e.g. jackets for flasks
• CPC Class Codes: B01L 9/06 : Test-tube stands; Test-tube holders
• CPC Class Codes: G06Q 10/0832 : Special goods or special handling procedures, e.g. handling of hazardous or fragile goods
• CPC Class Codes: G16H 10/40 : for data related to laboratory analysis, e.g. patient specimen analysis

Abstract

Bodily fluid sample collection systems, devices, and method are provided. The device may comprise a first portion comprising at least a sample collection channel configured to draw the fluid sample into the sample collection channel via a first type of motive force. The sample collection device may include a second portion comprising a sample vessel for receiving the bodily fluid sample collected in the sample collection channel, the sample vessel operably engagable to be in fluid communication with the collection channel, whereupon when fluid communication is established, the vessel and/or another source provides a second motive force different from the first motive force to move a majority of the bodily fluid sample from the channel into the vessel.

Claims

1. A method for use with a bodily fluid sample from a subject, the method comprising:

shipping a plurality of sample containers from a first location to a second location, wherein each of said sample containers contains a microsample of about 500 uL or less and wherein interior volume of each of the sample containers is about 600 uL or less,

wherein shipping of the plurality of samples containers is accomplished using a first frame sized to fit in a shipping container, said first frame comprises a plurality of openings each sized and shaped to engage at least one of the sample containers and hold the sample containers in a desired orientation;

obtaining data from each of the sample containers;

providing a plurality of processing frames at the second location;

using said data from the sample containers to determine which of said processing frames receive which of said sample containers and provide sorting information for the sample containers; and

moving said sample containers from the shipping frame to the processing frame based on data provided by the sample containers and based on said sorting information; and

handling the processing frame to simultaneously process the sample containers in the processing frame.

2. The method of claim 1 wherein each of the sample containers further comprises at least one sample container information storage unit, wherein obtaining data from the sample containers comprises simultaneously scanning a plurality of sample container information storage units simultaneously.

3. The method of claim 2 wherein said scanning occurs when the containers are in the shipping frame.

4. The method of claim 2 wherein said scanning comprises scanning an underside surface of each of the sample containers.

5. The method of claim 1 further comprising providing at least one database at a server, wherein determining which processing frames receive which of the sample containers comprises referencing the data with said at least one database at said server.

6. The method of claim 1 further comprising providing at least one database of subject identifiers at a server, wherein said data from the sample containers comprise at least one sample container identifier, and wherein said determining comprises matching said at least one sample container identifier with at least one of said subject identifiers.

7. The method of claim 1 further comprising providing a plurality of sample container processing procedures wherein said data from the sample containers comprise at least one sample container identifier, and wherein said determining comprises matching said at least one sample container identifier with one of said sample container processing procedures.

8. The method of claim 1 wherein at least some of the sample containers contain sample having a first anticoagulant and at least some other of the sample containers have a second, different anticoagulant.

9. The method of claim 1 wherein moving said sample containers comprises using a robotic manipulator.

10. A method for use with a bodily fluid sample from a subject, the method comprising:

shipping a plurality of sample containers from a first location to a second location, wherein each of said sample containers contains a microsample of about 500 uL or less and wherein interior volume of each of the sample containers is about 600 uL or less,

wherein shipping of the plurality of samples containers is accomplished using a first frame sized to fit in a shipping container, said first frame comprises a plurality of openings each sized and shaped to engage at least one of the sample containers and hold the sample containers in a desired orientation;

obtaining data from each of the sample containers;

providing a plurality of processing frames at the second location;

using said data from the sample containers to determine which of said processing frames receive which of said sample containers and provide sorting information for the sample containers; and

moving said sample containers from the shipping frame to the processing frame based on data provided by the sample containers and based on said sorting information; and

handling the processing frame to simultaneously process the sample containers in the processing frame,

wherein at least one of said sample containers from the subject contains sample having a first anticoagulant and at least another of the sample containers from the subject has a second, different anticoagulant.

11. The method of claim 10 wherein each of the sample containers further comprises at least one sample container information storage unit, wherein obtaining data from the sample containers comprises simultaneously scanning a plurality of sample container information storage units simultaneously.

12. The method of claim 11 wherein said scanning occurs when the containers are in the shipping frame.

13. The method of claim 11 wherein said scanning comprises scanning an underside surface of each of the sample containers.

14. The method of claim 10 further comprising providing at least one database at a server, wherein determining which processing frames receive which of the sample containers comprises referencing the data with said at least one database at said server.

15. The method of claim 10 wherein moving said sample containers comprises using a robotic manipulator.

16. A method for use with a bodily fluid sample from a subject, the method comprising:

shipping a plurality of sample containers from a first location to a second location, wherein each of said sample containers contains a microsample of about 500 uL or less and wherein interior volume of each of the sample containers is about 600 uL or less,

wherein shipping of the plurality of samples containers is accomplished using a first frame sized to fit in a shipping container, said first frame comprises a plurality of openings each sized and shaped to engage at least one of the sample containers and hold the sample containers in a desired orientation;

obtaining data from each of the sample containers;

providing a plurality of processing frames at the second location;

using said data from the sample containers to determine which of said processing frames receive which of said sample containers and provide sorting information for the sample containers; and

moving said sample containers from the shipping frame to the processing frame based on data provided by the sample containers and based on said sorting information; and

handling the processing frame to simultaneously process the sample containers in the processing frame at a processing frame centrifuge.

17. The method of claim 16 wherein at least some of the sample containers contain sample having a first anticoagulant and at least some other of the sample containers have a second, different anticoagulant.

18. The method of claim 16 wherein at least one of said sample containers from the subject contains sample having a first anticoagulant and at least another of the sample containers from the subject has a second, different anticoagulant.

19. The method of claim 16 wherein moving said sample containers comprises using a robotic manipulator.

20. The method of claim 16 wherein each of the sample containers further comprises at least one sample container information storage unit, wherein obtaining data from the sample containers comprises simultaneously scanning a plurality of sample container information storage units simultaneously.