IP Library Granted Patent US 11,112,418
Granted Patent B1
US 11,112,418 · App. 15/664,138 · Granted Sep 7, 2021

Systems and methods for multi-analysis

Inventors: Elizabeth A. Holmes (Palo Alto, CA); Daniel Young (San Francisco, CA); Samartha Anekal (San Jose, CA); Chinmay Pangarkar (Newark, CA)
Assignee: Labrador Diagnostics LLC
G01N35/0099B01L3/5027G01N15/1434G01N21/01G01N35/00584B01L2200/027B01L2200/028B01L2300/0627G01N2015/0065G01N2035/00158G01N2035/00306G01N2035/00465G01N2035/00683G01N2035/00772G01N2201/021
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Quick Facts
Patent No.
US 11,112,418
App. No.
15/664,138
Granted
Sep 7, 2021
Kind
B1
Abstract

Systems and methods are provided for sample processing. A device may be provided, capable of receiving the sample, and performing one or more of a sample preparation, sample assay, and detection step. The device may be capable of performing multiple assays. The device may comprise one or more modules that may be capable of performing one or more of a sample preparation, sample assay, and detection step. The device may be capable of performing the steps using a small volume of sample.

Claims (41)

1. A method of processing a biological sample, comprising:

a) introducing a sample having a volume of 500 microliters or less into a sample processing device comprising:

i) a sample handling system;

ii) at least a first and a second fluidically isolated vessel;

iii) a diluent; and

iv) a centrifuge, wherein the sample comprises bodily fluid at a first concentration;

b) with the aid of the sample handling system, introducing at least a portion of the sample into the centrifuge;

c) centrifuging the sample, to generate a centrifuged sample;

d) with the aid of the sample handling system, removing at least a portion of the centrifuged sample from the centrifuge; and

e) with the aid of the sample handling system, mixing at least a portion of the centrifuged sample with the diluent to generate a diluted sample, wherein the diluted sample comprises bodily fluid at a second concentration, and the second concentration of bodily fluid is one-half or less of the first concentration of bodily fluid;

f) with the aid of the sample handling system, transferring at least a portion of the diluted sample to the first and the second fluidically isolated vessels; and

g) moving at least one of said fluidically isolated vessels to an inspection station in line-of sight between a camera and a light source of the sample processing device;

h) inspecting the sample in one of said fluidically isolated vessels for sample errors, wherein the inspection station comprises a gap defined between the light source opposing the camera, said gap being sized to receive the at least one of said fluidically isolated vessels;

i) moving the sample in one of said fluidically isolated vessels to an optical detector separate from the camera for detecting optical signals from the sample;

wherein the inspection station is a stand-alone device separate from the optical detector, said inspection station comprising a chassis supporting the camera and light source thereon.

2. A method of preparing a biological sample, comprising:

a) introducing a biological sample and at least one isolated vessel into a sample processing device comprising a centrifuge and a sample handling system;

b) with the aid of the sample handling system, introducing at least a portion of the biological sample into the centrifuge, wherein the centrifuge comprises one or more cavities and wherein the one or more cavities are configured to receive a total of no more than 500 microliters between all of the one or more cavities;

c) centrifuging the sample, to generate a centrifuged sample;

d) with the aid of the sample handling system, removing at least a portion of the centrifuged sample from the centrifuge; and

e) with the aid of the sample handling system, transferring centrifuged sample removed from the centrifuge from step d) into the fluidically isolated vessel;

g) moving at least one of said fluidically isolated vessels to be placed in line-of sight between a camera and a light source of the sample processing device;

h) inspecting the sample via a lateral view in one of said fluidically isolated vessels between the camera and the light source for sample errors, wherein a gap is defined between the light source opposing the camera, said gap being sized to receive the at least one of said fluidically isolated vessels;

i) moving the sample in one of said fluidically isolated vessels to an optical detector separate from the camera for detecting optical signals from the sample;

wherein the camera and the light source are mounted to a common chassis, defining an inspection station separate from the optical detector.

3. The method of claim 1 further comprising inserting a cartridge into the sample processing device, said cartridge containing at least one reagent vessel.

4. The method of claim 3 wherein the cartridge further comprises a cytometry slide for performing a cytometry assay.

5. The method of claim 4 wherein the cartridge further comprises a piercing tip having a harpoon-shaped distal end.

6. A method of preparing a biological sample, comprising:

a) introducing a biological sample and at least one isolated vessel into a sample processing device comprising a centrifuge and a sample handling system;

b) with the aid of the sample handling system, introducing at least a portion of the biological sample into the centrifuge, wherein the centrifuge comprises one or more cavities and wherein the one or more cavities are configured to receive a total of no more than 500 microliters between all of the one or more cavities;

c) centrifuging the sample, to generate a centrifuged sample;

d) with the aid of the sample handling system, removing at least a portion of the centrifuged sample from the centrifuge; and

e) with the aid of the sample handling system, transferring centrifuged sample removed from the centrifuge from step d) into the fluidically isolated vessel;

g) moving at least one of said fluidically isolated vessels to be placed in line-of sight between a camera and a light source of the sample processing device;

h) inspecting the sample via a lateral view in one of said fluidically isolated vessels between the camera and the light source for sample errors, wherein a gap is defined between the light source opposing the camera, said gap being sized to receive the at least one of said fluidically isolated vessels;

i) moving the sample in one of said fluidically isolated vessels to an optical detector separate from the camera for detecting optical signals from the sample;

wherein the camera and the light source are mounted to a common chassis, defining an inspection station separate from the optical detector;

further comprising inserting a cartridge into the sample processing device, said cartridge containing at least one reagent vessel.

7. The method of claim 6 wherein the cartridge further comprises a cytometry slide for performing a cytometry assay.

8. The method of claim 7 wherein the cartridge further comprises a piercing tip having a harpoon-shaped distal end.

Assignments (5)
CHANGE OF NAME Recorded Apr 15, 2020
From: THERANOS IP COMPANY, LLC
To: LABRADOR DIAGNOSTICS LLC
Reel/Frame 052410/0432 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 16, 2018
From: THERANOS, INC.
To: THERANOS IP COMPANY, LLC
Reel/Frame 045356/0038 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 16, 2018
From: HOLMES, ELIZABETH A.; YOUNG, DANIEL; PANGARKAR, CHINMAY; ANEKAL, SAMARTHA
To: THERANOS, INC.
Reel/Frame 045356/0072 →
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 →
Continuity (7)
Provisional Application 62534195 · Jul 18, 2017
Provisional Application 62369179 · Jul 31, 2016
Provisional Application 62369133 · Jul 31, 2016
Provisional Application 62369135 · Jul 31, 2016
Provisional Application 62368961 · Jul 29, 2016
Provisional Application 62368995 · Jul 29, 2016
Provisional Application 62369006 · Jul 29, 2016
Cited By (13)
US 12,214,485 US 12,315,696 US 12,339,435 US 12,362,140 US 12,373,374 US 12,377,397 US 12,449,429 US 12,480,876 US 12,493,051 US 12,517,146 US 12,541,025 US 12,673,326 US 12,704,453