In vitro medical diagnostic device and system

• US 9,254,489 B2
• Filed: 12/06/2012
• Issued: 02/09/2016
• Est. Priority Date: 12/06/2011
• Status: Active Grant

• Current Assignee: Edan Diagnostics, Inc.
• Original Assignee: Edan Diagnostics, Inc.
• Inventors: Lin, Chao, Swanson, Paul David, Zhao, Zhixiang Jason
• Primary Examiner(s): NOGUEROLA, ALEXANDER STEPHAN
• Application Number:
  US13/707,510
• Publication Number:
  US 20130140179A1
• Time in Patent Office: 1,160 Days
• US Class Current: 1/1
• CPC Class Codes: B01L 2200/027 for microfluidic devices
• CPC Class Codes: B01L 2200/0673 Handling of plugs of fluid surrounded by immiscible fluid
• CPC Class Codes: B01L 2200/148 Specific details about calibrations
• CPC Class Codes: B01L 2300/0645 Electrodes
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2300/0838 Capillaries
• CPC Class Codes: B01L 2300/0867 Multiple inlets and one sample wells, e.g. mixing, dilution
• CPC Class Codes: B01L 2300/0883 Serpentine channels
• CPC Class Codes: B01L 2300/1805 Conductive heating, heat from thermostatted solids is conducted to receptacles, e.g. heating plates, blocks
• CPC Class Codes: B01L 2400/0487 fluid pressure, pneumatics
• CPC Class Codes: B01L 2400/0655 pinch valves
• CPC Class Codes: B01L 3/502715 characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: B01L 3/502738 characterised by integrated valves microvalves F16K99/0001
• CPC Class Codes: B01L 3/567 Valves, taps or stop-cocks in combination with burettes B01L3/0203; in general F16K
• CPC Class Codes: F16K 2099/0084 Chemistry or biology, e.g. "lab-on-a-chip" technology
• CPC Class Codes: F16K 99/0015 Diaphragm or membrane valves
• CPC Class Codes: F16K 99/0026 Valves using channel deformation
• CPC Class Codes: G01N 27/26 by investigating electrochemical variables; by using electrolysis or electrophoresis
• CPC Class Codes: G01N 27/3273 Devices therefor, e.g. test element readers, circuitry details not specific to biochemical electrodes G01N33/4875
• CPC Class Codes: G01N 27/4163 checking the operation of, or calibrating, the measuring apparatus G01N27/3274, G01N27/4175 and G01N33/0006 take precedence
• CPC Class Codes: G01N 33/492 : Determining multiple analytes

Abstract

The present disclosure relates to an in vitro medical diagnostic device that includes a removable calibration fluid cartridge. The device also includes a removable assay cartridge containing a polymer body with channels for fluid movement.

Claims

1. A diagnostic system, comprising:

a removable assay cartridge comprising fluid paths and a plurality of electrochemical sensors;

a removable calibration fluid cartridge;

a diagnostic device having a housing and processing electronics for conducting the diagnostics within the housing;

wherein the housing further comprises a first opening for receiving at least a portion of the removable assay cartridge and a second opening for receiving at least a portion of the removable calibration fluid cartridge;

wherein the processing electronics of the diagnostic device receive signals from the electrochemical sensors, and the removable assay cartridge and the removable calibration fluid cartridge engage for the communication of fluid so that there is no fluid communication from the removable assay cartridge to any surface of the diagnostic device and no fluid communication from the removable calibration fluid cartridge to any surface of the diagnostic device.

2. The diagnostic system of claim 1 in which the removable assay cartridge includes a gas inlet or outlet;

and

wherein the diagnostic device includes a pumping system having an outlet or inlet for engaging the gas inlet or outlet and for providing or removing gas to and from the removable assay cartridge.

3. The diagnostic system of claim 1, further comprising a valve control mechanism under control of the processing electronics and configured to control the flow of fluid in the removable assay cartridge without touching the fluid in the removable assay cartridge.

4. The diagnostic system of claim 3 in which the second opening comprises a calibration cartridge port, and wherein the diagnostics device further comprises a second valve control mechanism under control of the processing electronics, the valve control mechanism configured to control the flow of fluid in the calibration cartridge when the calibration cartridge is installed in the calibration cartridge port.

5. The diagnostic system of claim 1 in which the removable assay cartridge is at least semi-transparent and wherein the diagnostic device further comprises a light source caused to illuminate the semi-transparent material to indicate testing status.

6. The diagnostic system of claim 4, further comprising a third valve control mechanism in which one or more valves control a heating element configured to heat at least a portion of the removable assay cartridge, and one or more valves control one or more pins configured to retain the removable assay cartridge within the assay port.

7. A diagnostic device, comprising:

a housing having an assay port for receiving a removable assay cartridge;

a circuit receiving data from at least one electrochemical sensor on the removable assay cartridge when the removable assay cartridge is fully installed in the assay port;

processing electronics configured to receive the data from the circuit and to conduct diagnostics using the received data;

a valve control mechanism under control of the processing electronics and configured to control the flow of fluid in the removable assay cartridge without touching the fluid in the removable assay cartridge;

wherein the housing further comprises a calibration cartridge port for receiving a calibration cartridge; and

wherein the diagnostics device further comprises at least a second valve control mechanism under control of the processing electronics, the second valve control mechanism configured to control the flow of fluid in the calibration cartridge when the calibration cartridge is installed in the calibration cartridge port, and wherein the calibration fluid does not touch a surface of the diagnostic device during normal operation.

8. The diagnostic device of claim 7 in which the removable assay cartridge further comprises one or more electrochemical sensors under control of the processing electronics and configured to detect the volume of fluid within the removable assay cartridge and control the flow of fluid in the removable assay cartridge.

9. The diagnostic device of claim 7 in which the removable assay cartridge further comprises one or more overflow sensors under control of the processing electronics and configured to detect an overflow condition within the removable assay cartridge and to stop fluid flow to the removable assay cartridge upon detecting an overflow condition.

10. The diagnostic device of claim 7 in which the processing electronics are further configured to automatically eject the cartridge from a seated position when the diagnostic testing cycle is determined to be completed by the processing electronics.

11. The diagnostic device of claim 7, further comprising heating elements within the housing positioned to heat opposing sides of the removable assay cartridge when the assay cartridge is in a fully seated position, wherein the processing electronics cause the heating elements to heat, causing a substantially constant temperature gradient to exist between the two heating elements, and wherein the electrochemical sensor is positioned between the heating elements when the assay cartridge is in the fully seated position.

12. The diagnostic device of claim 11 in which the heating elements are heating plates biased to provide a level and secure fit between each heating plate and the opposite surfaces of the removable assay cartridge.

13. The diagnostic device of claim 7 in which the removable assay cartridge is at least semi-transparent and wherein the diagnostic device further comprises a light source caused to illuminate the semi-transparent material to indicate testing status.

14. The diagnostic device of claim 7, further comprising at least one position detector and wherein the processing electronics are configured to track a position for the removable assay cartridge using information from the at least one position detector.

15. The diagnostic device of claim 7 in which the valve control mechanism is configured to control a heating element configured to heat at least a portion of the removable assay cartridge, and the valve control mechanism is configured to control one or more pins configured to retain the removable assay cartridge within the assay port.

16. A diagnostic device, comprising:

a housing having an assay port for receiving a removable assay cartridge;

a circuit receiving data from at least one electrochemical sensor on the removable assay cartridge when the removable assay cartridge is fully installed in the assay port;

processing electronics configured to receive the data from the circuit and to conduct diagnostics using the received data, and wherein the processing electronics are further configured to automatically eject the cartridge from a seated position when the diagnostic testing cycle is determined to be completed by the processing electronics; and

a valve control mechanism under control of the processing electronics and configured to control the flow of fluid in the removable assay cartridge without touching the fluid in the removable assay cartridge.