Diagnostic devices incorporating fluidics and methods of manufacture

• US 8,506,778 B2
• Filed: 08/27/2010
• Issued: 08/13/2013
• Est. Priority Date: 12/02/2002
• Status: Active Grant

• Current Assignee: Siemens Healthcare Diagnostics Incorporated (Siemens AG)
• Original Assignee: Epocal Incorporated (Siemens AG)
• Inventors: Lauks, Imants, Maczuszenko, Andrzej
• Primary Examiner(s): Noguerola, Alex
• Application Number:
  US12/870,463
• Publication Number:
  US 20100321004A1
• Time in Patent Office: 1,082 Days
• Field of Search: 20440301-40315, 204409-412, 422502-505, 422 8201- 8203
• US Class Current: 204/412
• CPC Class Codes: B01L 2200/025 Align devices or objects to ensure defined positions relative to each other
• CPC Class Codes: B01L 2200/0689 Sealing
• CPC Class Codes: B01L 2200/148 Specific details about calibrations
• CPC Class Codes: B01L 2200/16 Reagents, handling or storing thereof
• 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 2300/0887 Laminated structure
• 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 2300/1827 using resistive heater
• CPC Class Codes: B01L 2400/0481 squeezing of channels or chambers
• CPC Class Codes: B01L 2400/0487 fluid pressure, pneumatics
• CPC Class Codes: B01L 2400/0683 mechanically breaking a wall or membrane within a channel or chamber
• CPC Class Codes: B01L 3/502707 characterised by the manufacture of the container or its components by shaping or joining plastic parts B29C59/00, B29C65/00; by laminating B32B37/00; manufacture of microstructural devices in general B81C
• CPC Class Codes: B01L 3/502715 characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: B01L 3/502723 characterised by venting arrangements
• CPC Class Codes: B01L 3/50273 characterised by the means or forces applied to move the fluids micropumps F04B19/006, of the membrane type F04B43/043
• CPC Class Codes: B01L 3/502738 characterised by integrated valves microvalves F16K99/0001
• CPC Class Codes: B01L 7/00 Heating or cooling apparatus autoclaves B01J3/04; Heat insulating devices
• CPC Class Codes: B32B 2038/047 Perforating
• CPC Class Codes: B32B 2425/00 Cards, e.g. identity cards, credit cards
• CPC Class Codes: B32B 37/06 : characterised by the heating method
• CPC Class Codes: B32B 37/10 : characterised by the pressing technique, e.g. using action of vacuum or fluid pressure
• CPC Class Codes: B32B 38/04 : Punching, slitting or perforating
• CPC Class Codes: G01N 2021/0193 : the sample being taken from a stream or flow to the measurement cell
• CPC Class Codes: G01N 2021/7756 : Sensor type
• CPC Class Codes: G01N 2035/00148 : Test cards, e.g. Biomerieux or McDonnel multiwell test cards
• CPC Class Codes: G01N 27/26 : by investigating electrochemical variables; by using electrolysis or electrophoresis
• CPC Class Codes: G01N 27/3272 : Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52
• CPC Class Codes: G01N 27/3274 : Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration coding of calibration information G01N33/48771
• CPC Class Codes: G01N 27/403 : Cells and electrode assemblies

Abstract

The present invention relates to diagnostic devices incorporating electrode modules and fluidics for performing chemical analyses. The invented devices consist of a sensor array formed on an electrode module, the sensor array being contained within a fluidic housing. The electrode module is a laminate of a perforated epoxy foil and a photo-formed metal foil with sensor membranes deposited into the perforations. The fluidic housing is an element consisting of a plastic card-like body with fluidic conduits and a sealed fluid reservoir contained in a foil-lined cavity.

Claims

1. An electrode module for use in a diagnostic card for sensing at least one component concentration in a fluid sample, comprising

a substantially planar insulator layer;

and

a substantially planar metal conductor layer laminated to the insulator layer;

the electrode module having a centrally located sensing region, a peripherally located contacting region and an intermediate heating region located between the sensing and contacting regions and surrounding the sensing region,

the insulator layer in the sensing region having a number of throughgoing apertures, a sensor membrane in each aperture for contact with the sample and for electrical contact with the conductor layer,

the conductor layer being divided into a corresponding number of conductor elements and a heater contact element electrically insulated from the conductor elements, each conductor element including a conductor path having a sensor end and an opposite contact pad end, the sensor ends being located in the sensing region of the module and below one of the apertures respectively and the contact pad ends being located in the contact region and the conductor path extending from the sensor end in the sensing region, through the heating region to the contact pad end in the contacting region,

the heater contact element being located in the heating region between the sensing and contacting regions and electrically insulated from the conductor elements, the heater contact element being shaped to surround the sensing region except for a connecting gap extending between the sensing and contact regions, the conductor paths extending through the connecting gap.

2. The electrode module as defined in claim 1, wherein the insulator layer is an epoxy resin foil and the conductor layer is a metal foil.

3. The electrode module as defined in claim 1, wherein the heater contact element includes a pair of connecting gaps located on opposite sides of the heating region and the conductor paths each extend through one of the connecting gaps.

4. The electrode module as defined in claim 1, wherein the heater contact element includes multiple connecting gaps corresponding in number to the conductor elements, each conductor path extending through one connecting gap.

5. The electrode module as defined in claim 2, wherein the module has a rectangular shape and the contacting region extends along a pair of opposite sides of the electrode module, the module including eight apertures and eight conductor elements, the contact pad ends being symmetrically evenly distributed in the contacting region in two rows along the opposite sides and the sensor ends being symmetrically arranged in two parallel rows in the sensing region.

6. An electrode module for use in a diagnostic card for sensing at least one component concentration in a fluid sample, comprising

a substantially planar insulator layer;

and

a substantially planar metal conductor layer laminated to the insulator layer;

the electrode module having a centrally located sensing region, a peripherally located contacting region and an intermediate heating region located between the sensing and contacting regions,

the insulator layer in the sensing region having a number of throughgoing apertures, a sensor membrane in each aperture for contact with the sample and for electrical contact with the conductor layer,

the conductor layer being divided into a corresponding number of conductor elements and a heater contact element electrically insulated from the conductor elements, each conductor element including a conductor path having a sensor end and an opposite contact pad end, the sensor ends being located in the sensing region of the module and below one of the apertures respectively and the contact pad ends being located in the contact region,

the heater contact element being located in the heating region between the sensing and contacting regions and electrically insulated from the conductor elements, the heater contact element being shaped to surround the sensing region except for a connecting gap extending between the sensing and contact regions and the conductor paths extending through the connecting gap,

wherein the conductor paths are tortuously long to reduce thermal conduction along the conductor paths.

7. An electrode module for use in a diagnostic card for sensing at least one component concentration in a fluid sample, comprising:

a substantially planar insulator layer; and

a substantially planar metal conductor layer laminated to the insulator layer;

the electrode module having a centrally located sensing region, a peripherally located contacting region and an intermediate heating region located between the sensing and contacting regions,

the insulator layer in the sensing region having a number of throughgoing apertures, a sensor membrane in each aperture for contact with the sample and for electrical contact with the conductor layer,

the conductor layer being divided into a corresponding number of conductor elements and a heater contact element electrically insulated from the conductor elements, each conductor element including a conductor path having a sensor end and an opposite contact pad end, the sensor ends being located in the sensing region of the module and below one of the apertures respectively and the contact pad ends being located in the contact region,

the heater contact element being located in the heating region between the sensing and contacting regions, shaped to surround the sensing region and electrically insulated from the conductor elements, the heater contact element having a connecting gap extending between the sensing and contact regions and the conductor paths extending through the connecting gap,

wherein the heater contact element includes multiple connecting gaps corresponding in number to the conductor elements, each conductor path extending through one connecting gap, and

wherein the connecting gaps and contact pad ends are positioned about the sensing region in such a way that all conductor paths are of equal length.

8. A diagnostic card for use with a card reader for sensing at least one component concentration of a fluid sample, comprising

a card body having a measurement cell for containing a sample fluid;

a passage for supplying the sample fluid to the measurement cell; and

an electrode module mounted to the card body and including a substantially planar insulator layer and a substantially planar metal conductor layer laminated to the insulator layer;

the electrode module having a centrally located sensing region, a peripherally located contacting region and an intermediate heating region located between the sensing and contacting regions and surrounding the sensing region,

the insulator layer in the sensing region having a number of throughgoing apertures, a sensor membrane in each aperture for contact with the sample fluid and for electrical contact with the conductor layer, the conductor layer being divided into a corresponding number of conductor elements and a heater contact element electrically insulated from the conductor elements, each conductor element including a conductor path having a sensor end and an opposite contact pad end, the sensor ends being located in the sensing region of the module and below one of the apertures respectively and the contact pad ends being located in the contact region and the conductor path extending from the sensor end in the sensing region, through the heating region to the contact pad end in the contacting region,

the heater element being located in the heating region between the sensing and contacting regions, shaped to surround the sensing region and electrically insulated from the conductor elements, the heater element having a connecting gap extending between the sensor and contact regions, the conductor paths extending through the connecting gap;

the electrode module being mounted to the card body for exposure of the sensor membranes to the measurement cell and for external access to the contact pad ends and the heater contact element.

9. The diagnostic card as defined in claim 8, wherein the insulator layer is an epoxy resin foil and the conductor layer is a metal foil.

10. The diagnostic card as defined in claim 8, wherein the insulator layer is adhesively bonded to the card body about the sensing region for preventing leakage of any fluid contained in the measurement cell about an edge of the electrode module to the conductor layer.

11. The diagnostic card as defined in claim 8, wherein the heater element includes a pair of connecting gaps located on opposite sides of the heating region and the conductor paths respectively extend through one of the connecting gaps.

12. The diagnostic card as defined in claim 8, wherein the module has a rectangular shape and the contacting region extends along a pair of opposite sides of the electrode module, the module including eight apertures and eight conductor elements, the contact pad ends being symmetrically evenly distributed in the contacting region along the opposite sides of the electrode module and the sensor ends being symmetrically arranged in two parallel rows in the sensing region.

13. The diagnostic card of claim 8, further including a passage for draining excess fluid away from the measurement cell.

14. A diagnostic card for use with a card reader for sensing at least one component concentration of a fluid sample, comprising

a card body having a measurement cell for containing a sample fluid;

a passage for supplying the sample fluid to the measurement cell; and

an electrode module mounted to the card body and including a substantially planar insulator layer and a substantially planar metal conductor layer laminated to the insulator layer;

the electrode module having a centrally located sensing region, a peripherally located contacting region and an intermediate heating region located between the sensing and contacting regions,

the insulator layer in the sensing region having a number of throughgoing apertures, a sensor membrane in each aperture for contact with the sample fluid and for electrical contact with the conductor layer, the conductor layer being divided into a corresponding number of conductor elements and a heater contact element electrically insulated from the conductor elements, each conductor element including a conductor path having a sensor end and an opposite contact pad end, the sensor ends being located in the sensing region of the module and below one of the apertures respectively and the contact pad ends being located in the contact region,

the heater element being located in the heating region between the sensing and contacting regions, shaped to surround the sensing region and electrically insulated from the conductor elements, the heater element having a connecting gap extending between the sensor and contact regions and the conductor paths extending through the connecting gap;

the electrode module being mounted to the card body for exposure of the sensor membranes to the measurement cell and for external access to the contact pad ends and the heater contact element,

wherein the conductor paths are tortuously long to reduce thermal conduction along the conductor paths.