Systems and methods for multi-analysis

• US 9,952,240 B2
• Filed: 10/01/2015
• Issued: 04/24/2018
• Est. Priority Date: 09/25/2011
• Status: Active Grant

• Current Assignee: Labrador Diagnostics LLC (SoftBank Group Corp.)
• Original Assignee: Theranos IP Company, LLC
• Inventors: Holmes, Elizabeth A., Chen, Michael, Ko, Pey-Jiun
• Primary Examiner(s): Ghafoorian, Reza
• Application Number:
  US14/872,995
• Publication Number:
  US 20160069921A1
• Time in Patent Office: 936 Days
• CPC Class Codes: B01L 2300/1827 using resistive heater
• CPC Class Codes: B01L 2300/1855 using phase changes in a medium
• CPC Class Codes: B01L 3/021 Pipettes, i.e. with only one conduit for withdrawing and redistributing liquids
• CPC Class Codes: B01L 3/5027 by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip B01L3/5023 takes precedence; micromixers B01F33/30; microreactors for synthesis B01J19/0093; microcapillary devices in general B81B1/00
• CPC Class Codes: B01L 3/5082 Test tubes per se
• CPC Class Codes: B01L 3/50855 using modular assemblies of strips or of individual wells
• CPC Class Codes: B01L 7/52 with provision for submitting samples to a predetermined sequence of different temperatures, e.g. for treating nucleic acid samples amplification or hybridisation processes per se C12Q1/68; controlling sequential reactions for synthesis B01J19/0046
• CPC Class Codes: B01L 9/06 Test-tube stands; Test-tube holders
• CPC Class Codes: B01L 9/52 Supports specially adapted for flat sample carriers, e.g. for plates, slides, chips
• CPC Class Codes: B01L 9/543 for disposable pipette tips, e.g. racks or cassettes
• CPC Class Codes: C12Q 1/42 involving phosphatase
• CPC Class Codes: C12Q 1/52 involving transaminase
• CPC Class Codes: C12Q 1/6883 for diseases caused by alterations of genetic material
• CPC Class Codes: C12Q 1/70 involving virus or bacteriophage immunoassay for viruses G01N33/56983
• CPC Class Codes: G01N 15/1433 using image recognition
• CPC Class Codes: G01N 2015/012 Red blood cells
• CPC Class Codes: G01N 2015/016 White blood cells
• CPC Class Codes: G01N 2015/1006 for cytology
• CPC Class Codes: G01N 2015/1486 Counting the particles
• CPC Class Codes: G01N 2035/00138 Slides
• CPC Class Codes: G01N 2035/00148 : Test cards, e.g. Biomerieux or McDonnel multiwell test cards
• CPC Class Codes: G01N 2035/00237 : Handling microquantities of analyte, e.g. microvalves, capillary networks
• CPC Class Codes: G01N 2035/00306 : Housings, cabinets, control panels (details)
• CPC Class Codes: G01N 2035/00326 : Analysers with modular structure
• CPC Class Codes: G01N 2035/00356 : Holding samples at elevated temperature (incubation)
• CPC Class Codes: G01N 2035/00366 : Several different temperatures used
• CPC Class Codes: G01N 2035/00425 : Heating or cooling means associated with pipettes or the like, e.g. for supplying sample/reagent at given temperature
• CPC Class Codes: G01N 2035/00435 : Refrigerated reagent storage
• CPC Class Codes: G01N 2035/00495 : Centrifuges
• CPC Class Codes: G01N 2035/00633 : logging process history of individual samples
• CPC Class Codes: G01N 2035/0449 : using centrifugal transport of liquid
• CPC Class Codes: G01N 2035/0474 : Details of actuating means for conveyors or pipettes
• CPC Class Codes: G01N 2035/0486 : Gearing, cams
• CPC Class Codes: G01N 2035/0491 : Position sensing, encoding; closed-loop control
• CPC Class Codes: G01N 2035/0493 : Locating samples; identifying different tube sizes
• CPC Class Codes: G01N 2035/0494 : Detecting or compensating piositioning errors
• CPC Class Codes: G01N 21/25 : Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
• CPC Class Codes: G01N 21/27 : using photo-electric detection G01N21/31 takes precedence; circuits for computing concentration logarithmic circuits G06G7/24; photometric circuits in general G01J
• CPC Class Codes: G01N 2201/024 : Modular construction
• CPC Class Codes: G01N 2201/04 : Batch operation; multisample devices
• CPC Class Codes: G01N 2201/12 : Circuits of general importance; Signal processing
• CPC Class Codes: G01N 33/5005 : involving human or animal cells immunoassay G01N33/56966; immunoassays of protozoa G01N33/56905; protozoa in screening assays C12Q1/025
• CPC Class Codes: G01N 33/54306 : Solid-phase reaction mechanisms
• CPC Class Codes: G01N 33/54313 : the carrier being characterised by its particulate form
• CPC Class Codes: G01N 33/54366 : Apparatus specially adapted for solid-phase testing
• CPC Class Codes: G01N 33/56972 : White blood cells
• CPC Class Codes: G01N 33/56983 : Viruses
• CPC Class Codes: G01N 33/62 : involving urea
• CPC Class Codes: G01N 33/6827 : Total protein determination, e.g. albumin in urine
• CPC Class Codes: G01N 33/80 : involving blood groups or blood types or red blood cells white blood cells G01N33/56972
• CPC Class Codes: G01N 33/92 : involving lipids, e.g. cholesterol , lipoproteins, or their receptors steroid hormones G01N33/743
• CPC Class Codes: G01N 35/00 : Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
• CPC Class Codes: G01N 35/00029 : provided with flat sample substrates, e.g. slides G01N35/028 takes precedence
• CPC Class Codes: G01N 35/00069 : whereby the sample substrate is of the bio-disk type, i.e. having the format of an optical disk
• CPC Class Codes: G01N 35/00623 : of instruments
• CPC Class Codes: G01N 35/00871 : Communications between instruments or with remote terminals
• CPC Class Codes: G01N 35/0092 : Scheduling
• CPC Class Codes: G01N 35/026 : having blocks or racks of reaction cells or cuvettes
• CPC Class Codes: G01N 35/04 : Details of the conveyor system G01N35/021 - G01N35/028 take precedence
• CPC Class Codes: G01N 35/10 : Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices G01N35/0099 takes precedence
• CPC Class Codes: G01N 35/1009 : Characterised by arrangements for controlling the aspiration or dispense of liquids
• CPC Class Codes: G01N 35/1011 : Control of the position or alignment of the transfer device
• CPC Class Codes: G01N 35/1065 : Multiple transfer devices
• CPC Class Codes: G01N 35/1072 : with provision for selective pipetting of individual channels
• CPC Class Codes: Y10T 436/111666 : Utilizing a centrifuge or compartmented rotor
• CPC Class Codes: Y10T 436/113332 : with conveyance of sample along a test line in a container or rack

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

1. A cartridge for use with a sample processing device, said cartridge comprising:

at least one sample collection unit;

at least one tip;

at least one reagent unit;

at least one assay unit;

at least one thermal device; and

a cartridge frame for supporting all of the foregoing and configured to be at least partially inserted into the sample processing device, wherein the at least one thermal device is mounted to the frame to position the at least one thermal device to thermally condition the at least one reagent unit.

2. The cartridge of claim 1, wherein the at least one reagent unit and the at least one assay unit are fluidically isolated and movable.

3. The cartridge of claim 1, wherein the at least one thermal device is capable of heating the cartridge.

4. The cartridge of claim 1, wherein the at least one thermal device is capable of cooling the cartridge.

5. The cartridge of claim 1, wherein the at least one thermal device thermally controls the temperature of a part of the cartridge without thermally affecting other parts of the cartridge.

6. The cartridge of claim 1, wherein the at least one thermal device comprises a chemical reaction pack.

7. The cartridge of claim 6, wherein the chemical reaction pack comprises at least one chemical selected from sodium acetate, calcium chloride, magnesium, iron, and sodium chloride.

8. The cartridge of claim 1, wherein the cartridge comprises at least two thermal devices, wherein the at least two thermal devices comprises a first thermal device and a second thermal device.

9. The cartridge of claim 8, wherein the first thermal device and the second thermal device are placed at different locations of the cartridge.

10. The cartridge of claim 8, wherein the first thermal device and the second thermal device are different sizes.

11. The cartridge of claim 1, further comprising at least one thermally conductive material coupled to predetermined portions of the frame.

12. The cartridge of claim 11, wherein the at least one thermally conductive material comprises at least one metal selected from aluminum, copper, silver, gold, steel, brass, iron, titanium, nickel, or any combination thereof.

13. The cartridge of claim 11, wherein the at least one thermally conductive material and the cartridge are made of different material.

14. The cartridge of claim 11, wherein the at least one thermally conductive material is integrated into a material used to form the cartridge.

15. The cartridge of claim 11, wherein the at least one thermally conductive material is located over the at least one thermal device.

16. The cartridge of claim 11, wherein the at least one thermally conductive material is spaced apart from the at least one thermal device.

17. The cartridge of claim 11, wherein the thermally conductive material is in contact with the at least one sample collection unit, the at least one tip, the at least one reagent unit, and/or the at least one assay unit.

18. The cartridge of claim 11, wherein the cartridge comprises at least two thermally conductive materials.

19. A cartridge for use with a sample processing device, said cartridge comprising:

at least one sample collection unit;

at least one tip;

at least one reagent unit;

at least one assay unit;

at least one thermal device; and

a cartridge frame for supporting all of the foregoing and configured to be at least partially inserted into the sample processing device, wherein the at least one thermal device is mounted to the frame to position the at least one thermal device to thermally condition the at least one reagent unit;

wherein the cartridge comprises all reagents for performing one or more assays on a biological sample obtained from a subject.

20. A cartridge for use with a sample processing device, said cartridge comprising:

at least one sample collection unit;

at least one tip;

at least one reagent unit;

at least one assay unit;

at least one thermal device; and

a cartridge frame for supporting all of the foregoing and configured to be at least partially inserted into the sample processing device, wherein the at least one thermal device is mounted to the frame to position the at least one thermal device to thermally condition the at least one reagent unit;

wherein the at least one sample collection unit is configured to receive a blood sample of no more than about 500 μ

l.