Calibration fluid cartridge for an in vitro medical diagnostic device

• US 9,901,928 B2
• Filed: 12/06/2012
• Issued: 02/27/2018
• Est. Priority Date: 12/06/2011
• Status: Active Grant

• Current Assignee: Edan Diagnostics, Inc.
• Original Assignee: Edan Diagnostics, Inc.
• Inventors: Lin, Chao, Swanson, Paul, Zhao, Zhixiang Jason
• Primary Examiner(s): White, Dennis M
• Assistant Examiner(s): Kilpatrick, Bryan
• Application Number:
  US13/707,517
• Publication Number:
  US 20130142709A1
• Time in Patent Office: 1,909 Days
• Field of Search: 422 681, 422 81, 422500, 422537, 422538, 422543, 422554, 436 43, 436180, 2044032
• 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 a calibration cartridge for an in vitro medical diagnostic device. The device also includes a removable assay cartridge containing a polymer body with channels for fluid movement.

Claims

1. A calibration fluid cartridge for a diagnostic device, comprising:

a chamber for holding unused calibration fluid;

a flow channel configured to receive calibration fluid from the chamber and to provide calibration fluid to an output;

a pinch valve moveable between an open position and a closed position and configured to control the flow of the calibration fluid through the fluid channel, wherein the pinch valve is configured to be actuated between the open position and the closed position by a pinch valve actuator subject to a spring bias pushing against the pinch valve, and wherein the calibration fluid cartridge does not carry the actuator;

a rod valve moveable between an open position and a closed position, wherein when the rod valve is in the closed position, the rod valve is caused to provide a pressing force against the fluid flow channel, thereby deforming the fluid flow channel wall and sealing the calibration fluid from flowing to a fluid output;

a housing containing the chamber and the flow channel, the housing partially containing the rod valve such that a portion of the rod valve protrudes from the housing; and

a cap coupled to the housing, the cap configured to interface with the portion of the rod valve such that

the rod valve is moved into the closed position when the cap for the calibration fluid cartridge is removed, prior to engagement with the diagnostic device;

wherein the rod valve is biased to the open position when the calibration fluid cartridge is inserted into the diagnostic device; and

wherein the rod valve is returned to the closed position when the calibration fluid cartridge is removed from the diagnostic device.

2. The calibration fluid cartridge of claim 1, further comprising:

a junction for receiving gas in the flow channel; and

a second pinch valve configured to control the flow of gas through the flow channel.

3. The calibration fluid cartridge of claim 2, further comprising:

an ambient air channel that receives ambient air and provides the air to the junction for receiving gas in the flow channel.

4. The calibration fluid cartridge of claim 2 in which the pinch valves control the air flow and calibration fluid flow to the output.

5. The calibration fluid cartridge of claim 1, further comprising:

an output needle and fluid conduit for communicating with a disposable assay cartridge.

6. The calibration fluid cartridge of claim 1 in which the output of the calibration fluid cartridge is located at the bottom of the calibration fluid container.

7. The calibration fluid cartridge of claim 1, further comprising an L shaped connector connected to the flow channel, the L-shaped connector positioned at the bottom of the calibration fluid cartridge and having one or more wings extending from the L-shaped connector and configured to maintain the flow of calibration fluid to the output.

8. A calibration fluid cartridge for a diagnostic device, comprising:

a chamber for holding unused calibration fluid;

a flow channel configured to receive calibration fluid from the chamber and to provide calibration fluid to an output;

a junction for receiving gas in the flow channel;

a system of valves such that gas and calibration fluid can controllably flow to the output;

an ambient air channel that receives ambient air and provides the air to the junction for receiving gas in the flow channel;

a first pinch valve for controlling the air flow to the output;

a second pinch valve for controlling the calibration fluid flow to the output;

a housing containing the chamber and the flow channel; and

a cap coupled to the housing, the cap configured to cause the flow channel to close when the cap is coupled to the housing;

wherein each pinch valve is actuated between an opened position and closed position by a pinch valve actuator pressing against the pinch valve; and

wherein the pinch valve actuator is not carried by the calibration fluid cartridge.

9. The calibration fluid cartridge of claim 8 in which the pinch valves are closed under pressure and open in the absence of pressure, wherein the one or more actuators are controlled by processing electronics.

10. The calibration fluid cartridge of claim 8, further comprising:

a rod valve that seals the calibration fluid from flowing to fluid output when the cap for the calibration fluid cartridge is removed, prior to engagement with the diagnostic device;

wherein the rod valve is released once the calibration fluid cartridge is inserted into the diagnostic device;

wherein the rod valve returns to the closed position again, to keep the remaining fluid inside cartridge, once it is disengaged with diagnostic device.

11. The calibration fluid cartridge of claim 8, further comprising:

an output needle and fluid conduit for communicating with disposable assay cartridge.

12. The calibration fluid cartridge of claim 8 in which the output of the calibration fluid cartridge is located at the bottom of the calibration fluid container.

13. The calibration fluid cartridge of claim 8, further comprising an L shaped connector connected to the flow channel, the L-shaped connector positioned at the bottom of the calibration fluid cartridge and having one or more wings extending from an outlet of the connector and configured to protect the output from being blocked.