IP Library Granted Patent US 11,754,554
Granted Patent B2
US 11,754,554 · App. 15/403,553 · Granted Sep 12, 2023

Systems and methods of fluidic sample processing

Inventors: Shaunak Roy (San Mateo, CA); Melissa Takahashi (Cambridge, MA); Ian Gibbons (Newark, CA); Edmond Ku (Sunnyvale, CA); Thanh Dang (San Jose, CA); Tammy Burd (San Jose, CA); Adam Vollmer (San Francisco, CA); Elizabeth A. Holmes (Palo Alto, CA)
Assignee: Labrador Diagnostics LLC
G01N33/5304G01N27/07G01N33/49G01N33/5302G01N33/86G01N35/1002G01N27/06G01N2201/12746G01N2800/52Y10S435/973Y10S436/809Y10T436/106664
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Quick Facts
Patent No.
US 11,754,554
App. No.
15/403,553
Granted
Sep 12, 2023
Kind
B2
Abstract

The present invention provides fluidic devices and systems that allow detection of analytes from a biological fluid. The methods and devices are particularly useful for providing point-of-care testing for a variety of medical applications.

Claims (27)

1. A system, comprising:

a sample processing device, comprising:

at least a first reagent reservoir and a second reagent reservoir;

a manifold connecting to the first and second reagent reservoirs; and

a calibration unit;

a cartridge comprising an assay assembly having a reaction site; and

a removable sample collection unit,

wherein the manifold fluidically routes a first reagent and a second reagent from the first reagent reservoir and the second reagent reservoir, respectively, to the cartridge, and

wherein the calibration unit comprises electrodes and is configured to provide a conductivity calibration measurement of a sample such that the calibration measurement is configured to calibrate a detectable signal from the assay assembly.

2. The system of claim 1 , wherein the sample collection unit comprises a sample dilution syringe, the sample dilution syringe comprising a housing.

3. The system of claim 2 , wherein the sample dilution syringe contains a capillary tube, and wherein the capillary tube can be press-fit into the housing of the sample dilution syringe.

4. The system of claim 2 , wherein the sample dilution syringe further contains a moveable mixing element.

5. The system of claim 4 , wherein the moveable mixing element is a mixing ball.

6. The system of claim 1 , wherein the sample collection unit is fluidically connected to the reaction site of the assay assembly.

7. The system of claim 1 , wherein the sample collection unit further comprises a filter.

8. The system of claim 1 , wherein the device further comprises a body, and wherein the body covers the first reagent reservoir, second reagent reservoir, manifold, and cartridge.

9. The system of claim 1 , wherein first lower septum of the first reagent reservoir is held in place by a crimpable metal cap.

10. The system of claim 1 , wherein the first reagent reservoir and second reagent reservoir each contain 100-500 microliters of liquid reagent.

11. The system of claim 1 , wherein the first reagent reservoir comprises collapsible plastic.

12. The system of claim 1 , wherein the reaction site of the assay assembly comprises antibodies.

13. The system of claim 1 , wherein the device further comprises a waste chamber in fluidic communication with the assay assembly.

14. The system of claim 1 , wherein the cartridge comprises an opaque material.

15. The system of claim 1 , wherein the cartridge comprises a clear material.

16. The system of claim 1 , wherein the sample collection unit comprises a diluent.

17. The system of claim 1 , further comprising:

a detector configured to detect an optical signal generated via an interaction between the sample and at least one of the first and second reagents.

18. The system of claim 1 , wherein the sample is a bodily fluid, and wherein the calibration measurement provided by the calibration unit comprises a dilution of the sample.

Assignments (5)
CHANGE OF NAME Recorded Apr 7, 2020
From: THERANOS IP COMPANY LLC
To: LABRADOR DIAGNOSTICS LLC
Reel/Frame 052329/0716 →
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 Jan 11, 2017
From: ROY, SHAUNAK; DANG, THANH; TAKAHASHI, MELISSA; BURD, TAMMY; VOLLMER, ADAM; GIBBONS, IAN; KU, EDMOND; HOLMES, ELIZABETH A.
To: THERANOS, INC.
Reel/Frame 040950/0886 →
Continuity (5)
Continuation 14534064 · Nov 5, 2014
Continuation 13436568 · Mar 30, 2012
Continuation 12221816 · Aug 6, 2008
Provisional Application 60954301 · Aug 6, 2007
Related Publication 20170192022A1 · Jul 6, 2017