IP Library Granted Patent US 10,488,643
Granted Patent B2
US 10,488,643 · App. 15/242,171 · Granted Nov 26, 2019

Systems, devices, and methods for sample integrity verification

Inventors: Zachary Morrison (Palo Alto, CA); Daniel Young (Palo Alto, CA); Sunny Balwani (Palo Alto, CA)
Assignee: Theranos IP Company, LLC
G02B21/367G01N21/03G01N35/00732G01N35/00871G02B7/1821G02B21/0004G02B21/06G02B21/34G02B21/361G02B21/362G02B21/365G01N2035/00891G01N2201/12
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Quick Facts
Patent No.
US 10,488,643
App. No.
15/242,171
Granted
Nov 26, 2019
Kind
B2
Abstract

The devices, systems, and methods disclosed herein provide sample verification capabilities in a single device or system. Devices are disclosed herein. Systems including these devices are also provided. These devices and systems may be configured for verifying sample integrity prior to a subject leaving a sample collection site so that any further samples or other corrective action can occur without having to make a separate visit.

Claims (30)

1. A sample verification device for use with a capped sample container containing at least one sample, the device comprising:

a housing providing a light-controlled imaging location;

at least one image capture device;

a communication module;

at least one illumination source positioned to backlight the sample container when the capped sample container is placed to be visualized by the at least one image capture device;

wherein said at least one image capture device is aligned to visualize a lateral side view of the capped sample container in a non-inverted orientation to collect visual information about a meniscus of the sample and collect information from an identification device on the sample container, whereby at least a portion of the visual information is transmitted by the communication module where said visual information is processed to alert a user if the sample fails to meet one or more sample collection criteria;

wherein the identification device is located on a surface of the sample container different from another surface of the sample container being imaged;

further comprising a mirror positioned below a receiving location where the sample to be imaged is placed and along an optical pathway between the at least one image capture device and the sample container.

2. The sample verification device of claim 1 wherein the at least one image capture device comprises a camera.

3. The sample verification device of claim 1 wherein the identification device comprises a bar code.

4. The sample verification device of claim 1 further comprising a light controlled housing for containing at least a portion of the sample and at least a portion of the at least one image capture device.

5. The sample verification device of claim 4 wherein the light controlled housing comprises a portion movable from a closed position to an open position to allow for loading of the sample container into the sample verification device.

6. The sample verification device of claim 4 wherein a region of interest of the at least one image capture devices comprises portions of at least two sample containers.

7. The sample verification device of claim 4 wherein a region of interest of the at least one image capture devices simultaneously images a portion of the sample and a visual identifier on the sample container.

8. The sample verification device of claim 1 further comprising a pipette and gantry system to transport the sample container to the light-controlled imaging location.

9. A method of performing sample verification comprising:

providing a housing providing a light-controlled imaging location;

providing at least one image capture device;

providing a communication module;

providing at least one illumination source positioned to backlight a sample container when the capped sample container is placed to be visualized by the at least one image capture device;

providing a pipette and gantry system;

using the pipette and gantry system to transport a capped sample container to be imaged by said at least one image capture device;

providing a mirror positioned below a receiving location where the sample to be imaged is placed and along an optical pathway between the at least one image capture device and the sample container;

capturing information using the at least one image capture device about at least one characteristic about a meniscus of the sample in the capped sample container by visualizing a lateral side view of the capped sample container in a non-inverted orientation and capturing information from an identification device on the sample container;

keeping a subject at the sample collection facility until sample verification is completed; and

communicating an alert to a user if the sample fails to meet at least one sample collection criteria, whereby a remedial action is taken before the subject departs from the sample collection facility.

10. The method of claim 9 , comprising placing the sample into a light-controlled imaging location.

11. The method of claim 9 wherein capturing comprises multi-axial imaging.

12. The method of claim 9 wherein capturing comprises multi-angle imaging.

13. The method of claim 9 wherein capturing comprises multi-angle imaging using a single capture device.

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 Aug 19, 2016
From: MORRISON, ZACHARY; BALWANI, SUNNY; YOUNG, DANIEL
To: THERANOS, INC.
Reel/Frame 039763/0637 →
Continuity (3)
Continuation PCTUS2015017581 · Feb 25, 2015
Provisional Application 61944557 · Feb 25, 2014
Related Publication 20170045729A1 · Feb 16, 2017