IP Library Granted Patent US 10,856,791
Granted Patent B2
US 10,856,791 · App. 15/244,990 · Granted Dec 8, 2020

Systems, devices, and methods for bodily fluid sample collection

Inventors: Patricia McHale (Palo Alto, CA); Michael Chen (Sunnyvale, CA); Pey-Jiun Ko (Redwood City, CA); Tammy Burd (Palo Alto, CA); Adrit Lath (Palo Alto, CA); Elizabeth A. Holmes (Palo Alto, CA); Joy Roy (Palo Alto, CA)
Assignee: Labrador Diagnostics LLC
A61B5/150946A61B5/15003A61B5/154A61B5/155A61B5/150022A61B5/15074A61B5/150099A61B5/15117A61B5/150213A61B5/150343A61B5/150351A61B5/150389A61B5/150503A61B5/150755A61B5/150763A61B5/150786A61B5/150992A61B10/0045B01L3/50273B01L3/502715G01N1/10G01N1/14A61B2010/008B01L2200/0605B01L2300/041B01L2300/0838B01L2300/0861B01L2300/16B01L2400/0406B01L2400/0487G01N2001/149
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Quick Facts
Patent No.
US 10,856,791
App. No.
15/244,990
Granted
Dec 8, 2020
Kind
B2
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 container for receiving the bodily fluid sample collected in the sample collection channel, the sample container operably engagable to be in fluid communication with the collection channel, whereupon when fluid communication is established, the container 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 container.

Claims (31)

1. A device for collecting a bodily fluid sample, the device comprising:

a first portion comprising a plurality of capillary collection channels;

a second portion comprising a plurality of sample containers for receiving the bodily fluid sample collected in the collection channels, wherein the sample containers each have a gas permeable and penetration re-sealable closure comprising a first layer of re-sealable material that is liquid impermeable and a second layer of gas porous, liquid impermeable layer;

a cap having an upper portion that seals against a portion of the re-sealable material of one of the sample containers and a sidewall portion that defines a vent space next to the gas porous, liquid impermeable layer of said one of the sample containers.

2. The device of claim 1 , wherein an interior of one of the capillary collection channels is coated with a first anticoagulant different from a second anticoagulant coating an interior of another of the capillary collection channels.

3. The device of claim 2 , wherein the first anticoagulant is ethylenediaminetetraacetic acid (EDTA).

4. The device of claim 2 , wherein the first anticoagulant is citrate.

5. The device of claim 2 , wherein the first anticoagulant is heparin.

6. The device of claim 1 , wherein interiors of each of the collection channels are coated with an anti-coagulant.

7. The device of claim 1 , wherein each of the capillary collection channels can hold a volume of no greater than 500 μL.

8. The device of claim 1 , wherein each of the capillary collection channels can hold a volume of no greater than 200 μL.

9. The device of claim 1 , wherein each sample container has an interior volume no greater than twenty times the interior volume of the capillary collection channel with which it is engagable.

10. The device of claim 9 , wherein each sample container has an interior volume no greater than ten times the interior volume of the capillary collection channel with which it is engagable.

11. The device of claim 10 , wherein each sample container has an interior volume no greater than five times the interior volume of the capillary collection channel with which it is engagable.

12. The device of claim 11 , wherein each sample container has an interior volume no greater than two times the interior volume of the capillary collection channel with which it is engagable.

13. The device of claim 1 , wherein establishment of fluidic communication between one of the capillary collection channels and one of the sample containers results in transfer of at least 90% of the bodily fluid sample in the capillary collection channel into the sample container.

14. The device of claim 13 , wherein no more than five μL of bodily fluid sample remain in the capillary collection channel upon establishment of said fluidic communication.

15. A device for collecting a bodily fluid sample, the device comprising:

a first portion comprising a plurality of capillary collection channels;

a second portion comprising a plurality of sample containers for receiving the bodily fluid sample collected in the capillary collection channels, wherein the sample containers each have a gas permeable and penetration re-sealable enclosure comprising a first layer of re-sealable material that is liquid impermeable and a second layer of gas porous, liquid impermeable layer, wherein a flow facilitator provides a favorable pathway from at least one of the capillary collection channels into at least one of the sample containers;

a cap having an upper portion that seals against a portion of the re-sealable material of each closure and a sidewall portion that defines a vent space next to the gas porous, liquid impermeable layer of each closure.

16. The device of claim 15 , wherein an interior of one of the capillary collection channels is coated with a first anticoagulant different from a second anticoagulant coating an interior of another of the capillary collection channels.

17. The device of claim 15 , wherein each of the capillary collection channels can hold a volume of no greater than 200 μL.

18. A device for collecting a bodily fluid sample, the device comprising:

a first portion comprising a plurality of capillary collection channels;

a second portion comprising a plurality of sample containers for receiving the bodily fluid sample collected in the collection channels, wherein the sample containers each have a gas permeable and penetration re-sealable closure comprising a first layer of re-sealable material that is liquid impermeable and a second layer of gas porous, liquid impermeable layer;

a plurality of caps, wherein each of the sample containers has one of said caps and each of said caps having an upper portion that seals against a portion of the re-sealable material on one of the sample containers and a sidewall portion that defines a vent space next to the gas porous, liquid impermeable layer on said one of the sample containers.

19. The device of claim 18 , wherein an interior of one of the capillary collection channels is coated with a first anticoagulant different from a second anticoagulant coating an interior of another of the capillary collection channels.

20. The device of claim 19 , wherein the first anticoagulant is ethylenediaminetetraacetic acid (EDTA).

21. The device of claim 19 , wherein the first anticoagulant is citrate.

22. The device of claim 19 , wherein the first anticoagulant is heparin.

Assignments (5)
CHANGE OF NAME Recorded Apr 15, 2020
From: THERANOS IP COMPANY, LLC
To: LABRADOR DIAGNOSTICS LLC
Reel/Frame 052410/0432 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 31, 2018
From: THERANOS, INC.
To: THERANOS IP COMPANY, LLC
Reel/Frame 045205/0686 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 25, 2018
From: LATH, ADRIT; CHEN, MICHAEL; KO, PEY-JIUN; HOLMES, ELIZABETH; BURD, TAMMY; MCHALE, PATRICIA; ROY, JOY
To: THERANOS, INC.
Reel/Frame 045153/0869 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 12, 2017
From: THERANOS INC.
To: THERANOS IP COMPANY, LLC
Reel/Frame 044838/0909 →
SECURITY INTEREST Recorded Dec 12, 2017
From: THERANOS IP COMPANY, LLC
To: FORTRESS CREDIT CORP.
Reel/Frame 044839/0568 →
Continuity (5)
Continuation PCTUS2015020307 · Mar 12, 2015
Provisional Application 62051906 · Sep 17, 2014
Provisional Application 61952130 · Mar 12, 2014
Provisional Application 61952125 · Mar 12, 2014
Related Publication 20170042460A1 · Feb 16, 2017
Cited By (14)
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