Systems and methods of fluidic sample processing

• US 9,575,058 B2
• Filed: 11/05/2014
• Issued: 02/21/2017
• Est. Priority Date: 08/06/2007
• Status: Active Grant

• Current Assignee: Labrador Diagnostics LLC (SoftBank Group Corp.)
• Original Assignee: Theranos Incorporated
• Inventors: Gibbons, Ian, Roy, Shaunak, Takahashi, Malissa, Ku, Edmond, Dang, Thanh, Burd, Tammy, Vollmer, Adam, Holmes, Elizabeth A.
• Primary Examiner(s): Chin, Chris L
• Application Number:
  US14/534,064
• Publication Number:
  US 20150168384A1
• Time in Patent Office: 839 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: G01N 2201/12746 Calibration values determination
• CPC Class Codes: G01N 27/06 of a liquid involving electrolysis G01N27/26
• CPC Class Codes: G01N 27/07 Construction of measuring vessels; Electrodes therefor
• CPC Class Codes: G01N 2800/52 Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
• CPC Class Codes: G01N 33/49 Blood chemical methods for determining blood cell populations G01N33/5094; chemical analysis of blood groups or blood types G01N33/80
• CPC Class Codes: G01N 33/5302 Apparatus specially adapted for immunological test procedures
• CPC Class Codes: G01N 33/5304 Reaction vessels, e.g. agglutination plates for solid-phase systems G01N33/543
• CPC Class Codes: G01N 33/86 involving blood coagulating time or factors, or their receptors
• CPC Class Codes: G01N 35/1002 Reagent dispensers
• CPC Class Codes: Y10S 435/973 Simultaneous determination of more than one analyte
• CPC Class Codes: Y10S 436/809 Multifield plates or multicontainer arrays
• CPC Class Codes: Y10T 436/106664 Blood serum or blood plasma standard or control

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

1. A device comprising:

at least a first reagent reservoir and a second reagent reservoir, wherein the first reagent reservoir comprises a first upper moveable seal, a first lower septum, and a first liquid reagent and the first liquid reagent is situated in the first reagent reservoir between the first upper moveable seal and first lower septum, and wherein the second reagent reservoir comprises a second upper moveable seal, a second lower septum, and a second liquid reagent, and the second liquid reagent is situated in the second reagent reservoir between the second upper moveable seal and the second lower septum;

a manifold comprising a first needle and a second needle; and

a cartridge comprising an assay assembly, wherein the assay assembly comprises a reaction site, wherein

the first reagent reservoir is positioned adjacent to the first needle of the manifold such that the first lower septum may be completely pierced by the first needle upon forced contact between the first reagent reservoir and the first needle, and wherein upon complete piercing of the first lower septum, the first liquid reagent may enter the first needle of the manifold;

the second reagent reservoir is positioned adjacent to the second needle of the manifold such that the second lower septum may be completely pierced by the second needle upon forced contact between the second reagent reservoir and the second needle, and wherein upon complete piercing of the second lower septum, the second liquid reagent may enter the second needle of the manifold; and

the manifold routes the first liquid reagent and second liquid reagent from the first reagent reservoir and the second reagent reservoir, respectively, to the cartridge, via at least the first needle and the second needle.

2. The device of claim 1, further comprising a sample collection unit.

3. The device of claim 2, wherein the sample collection unit is removable from the device.

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

5. The device of claim 2, wherein the sample collection unit is fluidically connected to the reaction site of the assay assembly.

6. The device of claim 2, wherein the sample collection unit further comprises a filter.

7. The device of claim 4, 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.

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

9. The device of claim 8, wherein the moveable mixing element is a mixing ball.

10. The device 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.

11. The device of claim 1, wherein the first lower septum of the first reagent reservoir is in contact with the first needle of the manifold without the first needle penetrating into the portion of the first reagent reservoir containing the first liquid reagent.

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

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

14. The device of claim 1, wherein the first reagent reservoir comprises collapsible plastic.

15. The device of claim 1, wherein the reaction site of the assay assembly comprises antibodies.

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

17. The device of claim 1, wherein the cartridge is made of a substantially opaque material.

18. The device of claim 1, wherein at least a portion of the cartridge is made of a clear material.

19. The device of claim 2, wherein the sample collection unit comprises a diluent.

20. The device of claim 2, wherein the sample collection unit comprises a blood sample.