Bodily fluid sample collection and transport

Patent metadata

Field	Value
Publication number	US-10371606-B2
Application number	US-201615290248-A
Country	US
Kind code	B2
Filing date	Oct 11, 2016
Priority date	Jul 21, 2015
Publication date	Aug 6, 2019
Grant date	Aug 6, 2019

Abstract

Bodily fluid sample collection systems, devices, and method are provided. The sample is collected at a first location and subjected to a first sample processing step. The sample may be shipped to a second location and subjected to a second sample processing step that does not introduce contaminants into a plasma portion of the sample formed from the first processing step. The sample may also be mixed with other material(s) in the collection device.

First claim

What is claimed is:

1. A device comprising:
a channel comprising an anticoagulant coating; and
a vessel configured to be in fluid communication with the channel,
wherein the device is configured to:
receive, in the channel, a bodily fluid sample provided by a subject;
mix, in the channel, the bodily fluid sample with the anticoagulant coating to generate a mixed bodily fluid sample based on a fluid flow of at least a portion of the bodily fluid sample across the anticoagulant coating; and
collect, in the vessel, the mixed bodily fluid sample,
wherein the anticoagulant coating comprises EDTA, and wherein the mixed bodily fluid sample comprises a bulk concentration of EDTA no less than about 2.5 milligrams per milliliter and no greater than about 10 milligrams per milliliter; wherein a concentration of the anticoagulant coating varies along a length of the channel according to a gradient.

2. The device of claim 1 , wherein the bulk concentration of EDTA is no less than about 3 milligrams per milliliter and no greater than about 4 milligrams per milliliter.

3. The device of claim 1 , wherein the device is further configured to mix the bodily fluid sample with the anticoagulant without generating a local concentration of EDTA greater than about 20 milligrams per milliliter.

4. The device of claim 1 , wherein the device is further configured to mix the bodily fluid sample with the anticoagulant with a shear rate no greater than about 1,000 reciprocal seconds.

5. The device of claim 1 , wherein the channel comprises a hydraulic diameter no less than about 0.5 millimeters and no greater than about 10 millimeters.

6. The device of claim 1 , wherein the channel comprises a mixing element, and wherein the device is further configured to mix, in the channel, the bodily fluid sample with the anticoagulant coating based on an advection.

7. The device of claim 6 , wherein the mixing element comprises a protrusion on a surface of the channel.

8. The device of claim 6 , wherein the mixing element comprises a staggered herringbone structure on a surface of the channel.

9. The device of claim 1 , wherein a magnitude of the gradient of the anticoagulant concentration decreases as the distance from an open end of the channel increases.

10. A device comprising:
a channel comprising an anticoagulant coating; and
a vessel configured to be in fluid communication with the channel,
wherein the device is configured to:
receive, in the channel, a bodily fluid sample provided by a subject;
mix, In the channel, the bodily fluid sample with the anticoagulant coating to generate a mixed bodily fluid sample based on a fluid flow of at least a portion of the bodily fluid sample across the anticoagulant coating; and
collect, in the vessel, the mixed bodily fluid sample,
wherein the anticoagulant coating comprises EDTA, and wherein the mixed bodily fluid sample comprises a bulk concentration of EDTA no less than about 2.5 milligrams per milliliter and no greater than about 10 milligrams per milliliter, wherein a thickness of the anticoagulant coating varies along a length of the channel according to a gradient.

11. The device of claim 10 , wherein a magnitude of the gradient of the anticoagulant thickness decreases as the distance from an open end of the channel increases.

12. A device comprising:
a channel comprising an anticoagulant coating; and
a vessel configured to be in fluid communication with the channel,
wherein the device is configured to:
receive, in the channel, a bodily fluid sample provided by a subject;
mix, in the channel, the bodily fluid sample with the anticoagulant coating to generate a mixed bodily fluid sample based on a fluid flow of at least a portion of the bodily fluid sample across the anticoagulant coating; and
collect, in the vessel, the mixed bodily fluid sample
wherein the anticoagulant coating comprises heparin, and wherein the mixed bodily fluid sample comprises a bulk concentration of heparin no less than about 20 units per milliliter and no greater than about 150 units per milliliter wherein a thickness of the anticoagulant coating varies along a length of the channel according to a gradient.

13. The device of claim 12 , wherein the device is further configured to mix the bodily fluid sample with the anticoagulant with a shear rate no greater than about 1,000 reciprocal seconds.

14. The device of claim 12 , wherein the channel comprises a hydraulic diameter no less than about 0.5 millimeters and no greater than about 10 millimeters.

15. The device of claim 12 , wherein the channel comprises a mixing element, and wherein the device is further configured to mix, in the channel, the bodily fluid sample with the anticoagulant coating based on an advection.

16. The device of claim 15 , wherein the mixing element comprises a protrusion on a surface of the channel.

17. The device of claim 15 , wherein the mixing element comprises a staggered herringbone structure on a surface of the channel.

18. The device of claim 12 , wherein a magnitude of the gradient of the anticoagulant thickness decreases as the distance from an open end of the channel increases.

Assignees

• Theranos Ip Co Llc
• Theraos Ip Company Llc

Inventors

• Holmes Elizabeth A
• Lui Clarissa
• Chen Michael
• Young Daniel

Classifications

• G01N2035/00326

  Analysers with modular structure · CPC title

• B01L2300/1822

  using Peltier elements · CPC title

• B01L2300/18

  Means for temperature control · CPC title

• B01L2300/0832

  cylindrical, tube shaped · CPC title

• B01L2300/044

  pierceable, e.g. films, membranes · CPC title