Systems, devices, and methods for bodily fluid sample collection

Patent metadata

Field	Value
Publication number	US-9636062-B2
Application number	US-201414214774-A
Country	US
Kind code	B2
Filing date	Mar 15, 2014
Priority date	Sep 6, 2012
Publication date	May 2, 2017
Grant date	May 2, 2017

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 from a subject, the device comprising:
a first portion comprising a plurality of sample collection channels, wherein at least two of the channels are configured to draw the fluid sample into each of the at least two sample collection channels via a first type of motive force, wherein the first portion defines a blunt, non-tissue penetrating distal end configured for collecting sample from an outer surface of the subject;
a second portion comprising a plurality of sample containers for receiving the bodily fluid sample collected in the sample collection channels, whereupon when the sample containers are operably engaged from a first condition to a second condition, the containers provide a second motive force different from the first motive force to move bodily fluid sample along at least one fluid pathway from the first portion into the containers of the second portion;
wherein the sample collection channels each have a longitudinal dimension greater than a sample container longitudinal dimension of each of the sample containers, such that each of the sample collection channels holds at least a predetermined amount sample for that channel and substantially all of said predetermined amount is transferred via the second motive force into an associated one of the sample containers;
a body portion coupling the first portion with the second portion,
a base coupled to the body portion, wherein the base comprises an optical indicator that provides a visual indication of whether the sample has reached the sample container in the base; and
a slide interface between the base holding the sample containers and the body portion.

2. The device of claim 1 wherein an interior of each of the collection channels is coated with at least one anticoagulant.

3. 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.

4. The device of claim 3 , wherein the first anticoagulant is ethylenediaminetetraacetic acid (EDTA) and the second anticoagulant is different from EDTA.

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

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

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

8. The device of claim 1 , wherein the base has a window that allows a user to see the container in the base portion.

9. 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.

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

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

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

13. The device of claim 12 , 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.

14. 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.

15. 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 channels into the sample containers.

16. 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 collection channel.

17. 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 collection channel.

Assignees

• Theranos Inc

Inventors

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

Classifications

• A61B5/150351

  Caps, stoppers or lids for sealing or closing a blood collection vessel or container, e.g. a test-tube or syringe barrel · CPC title

• A61B5/15117

  comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap · CPC title

• A61B5/150824

  by visual feedback · CPC title

• B01L2300/0672

  Integrated piercing tool · CPC title

• B01L3/563

  Joints or fittings; Separable fluid transfer means to transfer fluids between at least two containers, e.g. connectors · CPC title