FLUID HANDLING APPARATUS AND CONFIGURATIONS

• US 20130078625A1
• Filed: 09/26/2011
• Published: 03/28/2013
• Est. Priority Date: 09/25/2011
• Status: Active Grant

• Current Assignee: Labrador Diagnostics LLC (SoftBank Group Corp.)
• Original Assignee: Theranos Incorporated
• Inventors: Holmes, Elizabeth, Roy, Joy
• Granted Patent: US 9,664,702 B2
• Time in Patent Office: Days
• US Class Current: 435/6.11
• CPC Class Codes: B01L 3/0279 co-operating with positive ejection means
• CPC Class Codes: G01N 2030/8827 involving nucleic acids
• CPC Class Codes: G01N 2035/00326 Analysers with modular structure
• CPC Class Codes: G01N 2035/103 using disposable tips
• CPC Class Codes: G01N 2035/1048 using the transfer device for another function
• CPC Class Codes: G01N 35/0092 Scheduling
• CPC Class Codes: G01N 35/1065 Multiple transfer devices

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 sample processing apparatus for use with a biological sample and/or a reagent, comprising:

a sample preparation station, assay station, and/or detection station;

a control unit having a processor that is programmed to execute computer-readable commands for performing a point-of-service service at a designated location with the aid of at least one of said sample preparation station, assay station and detection station; and

a sample handling system having at least a first pipette and a second pipette each mounted on a common support structure, wherein at least one of the first pipette and the second pipette is independently movable and independently controllable in relation to the other, wherein the sample handling system transfers the biological sample or the reagent from or to one or more of said stations.

2. The apparatus of claim 1, wherein the first pipette and/or second pipette is configured to dispense and/or aspirate a fluid having a volume no more than 100 uL.

3. The apparatus of claim 1, wherein the pipettes each have a pipette nozzle configured to connect with a tip that is removable from the pipette nozzle, and wherein the tip of the first pipette and/or second pipette is configured to hold a sample having a volume no more than 100 uL.

4. The apparatus of claim 1, wherein the processor of the control unit is programmed to perform the point-of-service service at a site selected from the group consisting of a retailer site, the subject'"'"'s home, and a health assessment/treatment location.

23. The apparatus of claim 1, wherein the processor of the control unit is programmed to regulate the independent movement of at least one of said first pipette and said second pipette.

24. The apparatus of claim 1, wherein both the first pipette and the second pipette are independently movable and independently controllable in relation to the other.

25. The apparatus of claim 24, wherein the first and second pipettes include internal actuation mechanisms that are independently movable in relation to one another.

26. The apparatus of claim 25, wherein at least one of said internal actuation mechanisms is within a pipette head of said first pipette or second pipette and is configured to be movable within the pipette head.

30. The apparatus of claim 1 wherein each pipette has a pipette nozzle configured to connect with a tip that is removable from said pipette nozzle, wherein at least one of said first pipette and second pipette is configured to transport a fluid volume no more than 250 uL within or amongst said preparation station, assay station and/or detection station.

31. The apparatus of claim 1 wherein at least one of the pipettes exhibits a coefficient of variation of 5% or less when handling a fluid volume of 5 uL or less.

32. The apparatus of claim 1 wherein the control unit executes computer-executable commands to monitor and evaluate performance of the one or more stations at any given addressable location, and based on said evaluation send instructions to said system to alter or maintain the performance of the one or more stations.

33. The apparatus of claim 32 wherein said evaluation identifies malfunctioning of the one or more stations wherein sending said instructions to said system effects correction of said malfunctioning in real time.

34. The apparatus of claim 1 wherein the apparatus performs said point-of-service service with a coefficient of variation of less than or equal to 15%.

5. An apparatus for receiving, processing and/or analyzing a biological sample, comprising:

a sample preparation station, assay station, and/or detection station, each of which being identified by an individually addressable location within or amongst the stations;

a control unit having a processor that is programmed to execute computer-readable commands for performing a point-of-service service at a designated location with the aid of at least one of said sample preparation station, assay station and detection station; and

a sample handling system having at least a first pipette and a second pipette each mounted on a support structure, bodies of which first pipette and second pipette are independently movable in relation to one another, each of said first pipette and said second pipette having a pipette nozzle configured to connect with a removable tip, wherein one of said first pipette and second pipette is configured to connect with a tip of different size and/or shape than the other of the first pipette and second pipette.

6. The apparatus of claim 5, wherein said apparatus dispenses and/or aspirates fluid with a minimum increment of no more than 1 uL.

7. The apparatus of claim 5 further comprising a plurality of plungers, wherein at least one plunger is within a pipette head of one of said first pipette and second pipette and is configured to be movable within the pipette head, and wherein individual plungers are movable independent of each other.

8. The apparatus of claim 5 wherein said first pipette is configured to dispense and/or aspirate up to 100 uL and said second pipette is configured to dispense and/or aspirate up to 5 mL.

35. The apparatus of claim 5, wherein the processor of the control unit is programmed to regulate the independent movement of at least one of said first pipette and said second pipette.

36. The apparatus of claim 5, wherein said first pipette is of a type and/or size that is different from said second pipette.

37. The apparatus of claim 5, wherein the first and second pipettes include internal actuation mechanisms that are independently movable in relation to one another.

9-14. -14. (canceled)

15. An apparatus for handling a fluid, comprising:

a supporting body, extending therefrom a plurality of pipette heads comprising;

a positive displacement pipette head, comprising a positive displacement pipette nozzle configured to connect with a first removable tip; and

an air displacement pipette head, comprising an air displacement pipette nozzle configured to connect to an air displacement pipette tip,

wherein said positive displacement pipette head and air displacement pipette head are independently movable in relation to one another.

16. The apparatus of claim 15 that is configured to dispense and/or aspirate 1 uL to 5 mL of fluid with a coefficient of variation of 5% or less.

17. The apparatus of claim 15, further comprising at least one pipette having a pipette nozzle configured to connect with a tip that is removable from said pipette nozzle, wherein the pipette has a height, width, and length each of which dimension does not exceed 20 cm.

18. The apparatus of claim 17 wherein the pipette has a height which does not exceed 7 cm.

27. The apparatus of claim 15, wherein the sample handling system further comprises a processor programmed to regulate the independent movement of at least one of said positive displacement pipette head and said air displacement pipette head.

28. The apparatus of claim 15, wherein the positive displacement pipette head and air displacement pipette head include internal actuation mechanisms that are independently movable in relation to one another.

29. The apparatus of claim 28, wherein at least one of said internal actuation mechanisms is within said positive displacement pipette head or air displacement pipette head and is configured to be movable within said positive displacement pipette head or air displacement pipette head.

19-22. -22. (canceled)

38. A sample processing apparatus for use with a biological sample and/or a reagent, comprising:

a sample preparation station, assay station, and/or detection station;

a control unit having a processor that is programmed to execute computer-readable commands for performing a point-of-service service at a designated location with the aid of at least one of said sample preparation station, assay station and detection station; and

a sample handling system comprising at least a first pipette nozzle and a second pipette nozzle each supported by a common support structure, wherein at least one of the first pipette nozzle and the second pipette nozzle is independently movable and independently controllable in relation to the other, wherein the sample handling system transfers the biological sample or the reagent from or to one or more of said stations.

39. The apparatus of claim 38, wherein the first pipette nozzle and/or the second pipette nozzle is configured to dispense and/or aspirate a fluid of no more than 100 μ

l.

40. The apparatus of claim 38, wherein both the first pipette nozzle and the second pipette nozzle are independently movable and independently controllable in relation to the other.