IP Library Granted Patent US 10,371,606
Granted Patent B2
US 10,371,606 · App. 15/290,248 · Granted Aug 6, 2019

Bodily fluid sample collection and transport

Inventors: Elizabeth A. Holmes (Palo Alto, CA); Clarissa Lui (Menlo Park, CA); Michael Chen (Sunnyvale, CA); Daniel Young (Palo Alto, CA)
Assignee: Theraos IP Company, LLC
G01N1/20A61B5/151A61B5/150022A61B5/150251A61B5/150343A61B5/150755B01L3/502B01L3/5025B01L3/52B01L3/545G01N1/38G01N1/4077G01N33/491B01L2200/185B01L2300/022B01L2300/044B01L2300/0832B01L2300/0864B01L2300/0877B01L2300/18B01L2300/1822B01L2400/0409G01N2001/005G01N2001/4083G01N2035/00326
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Quick Facts
Patent No.
US 10,371,606
App. No.
15/290,248
Granted
Aug 6, 2019
Kind
B2
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.

Claims (39)

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.

Assignments (5)
CHANGE OF NAME Recorded Apr 3, 2020
From: THERANOS IP COMPANY, LLC
To: LABRADOR DIAGNOSTICS LLC
Reel/Frame 052313/0011 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 16, 2018
From: THERANOS, INC.
To: THERANOS IP COMPANY, LLC
Reel/Frame 045075/0310 →
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 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 24, 2016
From: HOLMES, ELIZABETH A.; LUI, CLARISSA; CHEN, MICHAEL; YOUNG, DANIEL
To: THERANOS, INC.
Reel/Frame 040100/0711 →
Continuity (4)
Continuation In Part 15216658 · Jul 21, 2016
Provisional Application 62239636 · Oct 9, 2015
Provisional Application 62195287 · Jul 21, 2015
Related Publication 20170122846A1 · May 4, 2017
Cited By (2)
US 12,434,889 US 12,588,845