Systems, devices, and methods for bodily fluid sample collection

Patent metadata

Field	Value
Publication number	US-10856791-B2
Application number	US-201615244990-A
Country	US
Kind code	B2
Filing date	Aug 23, 2016
Priority date	Mar 12, 2014
Publication date	Dec 8, 2020
Grant date	Dec 8, 2020

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.

First claim

What is claimed is:

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.

Assignees

• Labrador Diagnostics Llc

Inventors

• Mchale Patricia
• Chen Michael
• Ko Pey-Jiun
• Burd Tammy
• Lath Adrit
• Holmes Elizabeth A
• Roy Joy

Classifications

• A61B10/0045 Primary

  Devices for taking samples of body liquids · CPC title

• A61B5/150389

  Hollow piercing elements, e.g. canulas, needles, for piercing the skin · CPC title

• G01N1/10

  in the liquid or fluent state {(burettes, pipettes B01L3/02; sampling of ground water E02D1/06; metering by volume of fluids or fluent solid material G01F11/00, G01F13/00)} · CPC title

• A61B5/150992

  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 or valves · CPC title

• A61B5/15003

  for venous or arterial blood · CPC title