Diagnostic devices incorporating fluidics and methods of manufacture

• US 9,753,003 B2
• Filed: 06/21/2013
• Issued: 09/05/2017
• 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, ALEXANDER STEPHAN
• Application Number:
  US13/923,845
• Publication Number:
  US 20130277215A1
• Time in Patent Office: 1,537 Days
• 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 analyzes. The invented devices consist of at least one component sensor formed on an electrode module, the sensor 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 a diagnostic card consisting of a plastic card-like body, the at least one component sensor, a sealed chamber defined in the card body for containing a fluid, a fluid conduit for fluidically connecting the chamber with the sensor region, a valve for fluidically connecting the chamber to the fluid conduit, and a delivery structure separate and distinct from the valve for forcing fluid from the chamber and into the fluid conduit.

Claims

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

a card body

at least one component sensor located in a sensor region of the card body;

a sealed chamber defined in the card body outside the sensor region for containing a fluid, the chamber having a chamber wall sealing the chamber;

a fluid conduit for fluidically connecting the chamber with the sensor region, when the chamber is opened;

a valve for fluidically connecting the chamber to the fluid conduit, the valve having a structure for rupturing the chamber wall of the sealed chamber at the connection to the fluid conduit without pressurization of the chamber, thereby opening the chamber; and

a delivery structure for forcing fluid from the chamber and into the fluid conduit, when the chamber contains fluid, the delivery structure being operable independently of the valve and being formed by a flexible portion of the chamber wall which flexible portion is deformable for reduction of the chamber by external application of a deforming force.

2. The diagnostic card of claim 1, wherein the chamber is formed of a laminate of two opposed, plastic coated metal foil laminations bonded about their perimeter by a first heat seal made by melt bonding the plastic coatings of the laminations.

3. The diagnostic card of claim 2, wherein the heat seal has a width of at least 3 mm.

4. The diagnostic card of claim 2, wherein the card body includes molded contours and one of the foil laminations is pressure-formed into the contours of the card body.

5. The diagnostic card of claim 2, wherein the card body includes molded contours and one of the foil laminations is pressure-formed into the contours of the card body.

6. The diagnostic card of claim 1, wherein the card body includes a valve seat and the valve includes a valve body displaceably received in the valve seat, the valve rupturing the portion of the chamber wall upon displacement of the valve body relative to the valve seat.

7. The diagnostic card of claim 1, wherein the chamber has a chamber volume and the flexible portion of the chamber wall is deformable for reduction of the chamber volume.

8. The diagnostic card of claim 1, wherein the chamber has a chamber volume and the flexible portion of the chamber wall is deformable for reduction of the chamber volume.

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

a card body

at least one component sensor located in a sensor region of the card body;

a sealed chamber defined in the card body outside the sensor region for containing a fluid, the chamber having a chamber wall sealing the chamber and being formed of a laminate of two opposed, plastic coated metal foil laminations bonded about their perimeter by a first heat seal made by melt bonding the plastic coatings of the laminations;

a fluid conduit for fluidically connecting the chamber with the sensor region, when the chamber is opened;

a valve seat in the card body and a valve for fluidically connecting the chamber to the fluid conduit, the valve including a valve body displaceably received in the valve seat and sandwiched between the laminations within the chamber, the valve body rupturing one of the laminations upon displacement of the valve body relative to the valve seat for rupturing the chamber wall of the sealed chamber at the connection to the fluid conduit without pressurization of the chamber, thereby opening the chamber; and

a delivery structure for forcing fluid from the chamber and into the fluid conduit, when the chamber contains fluid, the delivery structure being operable independently of the valve and being formed by a flexible portion of the chamber wall which flexible portion is deformable for reduction of the chamber by external application of a deforming force.

10. The diagnostic card of claim 9, wherein the valve body is a rupture plug and the valve seat is a plug receiving bore in the card body.

11. The diagnostic card of claim 10, wherein the plug and plug receiving bore include cooperating edges for rupturing the one of the laminations upon displacement of the plug in the plug receiving bore.

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

a planar card body having a pair of opposite planar external surfaces;

at least one sensor located in a sensor region of the card body;

a sample entry port in one of the external surfaces of the card for receiving a conduit for sample fluid infection;

a sample conduit within the card body for fluidically connecting the sample entry port to the sensor region; and

an adhesive gasket on the one external surface and surrounding the sample entry port for forming a liquid seal about the conduit, when inserted into the sample entry port.

13. The diagnostic card of claim 12, further comprising

a sealed chamber defined in the card body outside the sensor region for containing a fluid, the chamber having a chamber wall sealing the chamber;

and

a fluid conduit for fluidically connecting the chamber with the sensor region, when the chamber is opened;

a valve for fluidically connecting the chamber to the fluid conduit, the valve having a structure for rupturing the chamber wall of the sealed chamber at the connection to the fluid conduit without pressurization of the chamber, thereby opening the chamber; and

a delivery structure for forcing fluid from the chamber and into the fluid conduit, when the chamber contains fluid, the delivery structure being operable independently of the valve and being formed by a flexible portion of the chamber wall which flexible portion is deformable for reduction of the chamber by external application of a deforming force.

14. The diagnostic card of claim 13, wherein the chamber is formed of a laminate of two opposed, plastic coated metal foil laminations bonded about their perimeter by a first heat seal made by melt bonding the plastic coatings of the laminations.

15. The diagnostic card of claim 14, wherein the heat seal has a width of at least 3 mm.

16. The diagnostic card of claim 13, wherein the card body includes a valve seat and the valve includes a valve body displaceably received in the valve seat, the valve rupturing the portion of the chamber wall upon displacement of the valve body relative to the valve seat.

17. The diagnostic card of claim 13, wherein the card body includes a valve seat and the valve includes a valve body displaceably received in the valve seat, the valve body being sandwiched between the laminations within the chamber, the valve rupturing one of the laminations upon displacement of the valve body relative to the valve seat.

18. The diagnostic card of claim 17, wherein the valve body is a rupture plug and the valve seat is a plug receiving bore in the card body.

19. The diagnostic card of claim 18, wherein the plug and plug receiving bore include cooperating edges for rupturing the one of the laminations upon displacement of the plug in the plug receiving bore.