Systems, devices, and methods for bodily fluid sample collection

Patent metadata

Field	Value
Publication number	US-9877674-B2
Application number	US-201314020435-A
Country	US
Kind code	B2
Filing date	Sep 6, 2013
Priority date	Sep 6, 2012
Publication date	Jan 30, 2018
Grant date	Jan 30, 2018

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 fluid sample from a subject, comprising:
(a) a body containing at least a portion of at least one collection channel, the collection channel comprising a tube-shaped structure having a first opening a second opening, and a conduit therebetween, and being configured to draw a bodily fluid via capillary action from the first opening towards the second opening;
(b) at least one adaptor channel having a first opening and a second opening, the first opening aligned with the second opening of the collection channel and
(c) at least one sample container movable between a first position on the device and a second position on the device to engage the adaptor channel, wherein the container has a container length less than a length of the collection channel;
wherein the adaptor channel being configured to penetrate a cap of the sample container and has a cross-sectional area less than a cross-sectional area of the collection channel;
wherein the body comprises an optical indicator that provides a visual indication of whether the sample has reached a level;
a slide interface between the base holding the sample containers and the body portion.

2. The device of claim 1 wherein the body comprises at least two collection channels.

3. The device of claim 1 wherein an interior of the collection channel is coated with an anticoagulant.

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

5. The device of claim 4 , wherein the first anticoagulant is ethylenediaminetetraacetic acid (EDTA) and the second anticoagulant is different from EDTA.

6. The device of claim 4 , wherein the first anticoagulant is citrate and the second anticoagulant is different from citrate.

7. The device of claim 4 , wherein the first anticoagulant is heparin and the second anticoagulant is different from heparin.

8. The device of claim 1 , wherein the body is formed from an optically transmissive material.

9. The device of claim 1 wherein the number of sample containers is the same as the number of collection channels.

10. The device of claim 1 further comprising a base coupled to the body.

11. The device of claim 10 , wherein the base is a window that allows a user to see the container in the base.

12. The device of claim 1 , wherein the second opening of the collection channel or the adaptor channel is capped by a sleeve, wherein said sleeve does not prevent movement of bodily fluid via capillary action from the first opening towards the second opening.

13. The device of claim 1 , wherein each collection channel can hold a volume of no greater than 200 uL.

14. The device of claim 1 , wherein each collection channel can hold a volume of no greater than 100 uL.

15. The device of claim 2 , wherein an opening of the first channel is adjacent to an opening of said second channel, and the openings are configured to draw blood simultaneously from the fluid sample.

16. The device of claim 15 , wherein the opening of the first channel and the opening of the second channel have a center-to-center spacing of less than or equal to about 5 mm.

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

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

19. The device of claim 1 , wherein the sample container provides a motive force different from capillary action to move fluid sample into the sample container when the sample container is in fluid communication with the adaptor channel.

20. The device of claim 1 further comprising a fluid flow mechanism that provides a motive force different from capillary action to move fluid sample from the collection channel into the sample container when the sample container is in fluid communication with the adaptor channel.

Assignees

• Theranos Inc
• Theranos Ip Co Llc

Inventors

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

Classifications

• A61B5/15016

  by accessories for bringing the piercing element into the body, e.g. through rotation of the piercing element · CPC title

• A61B2010/008

  Interstitial fluid · CPC title

• A61B5/154

  {Devices} using pre-evacuated means · CPC title

• B01L2400/049

  vacuum · CPC title

• A61B5/150022

  for capillary blood or interstitial fluid · CPC title