Diagnostic devices incorporating fluidics and methods of manufacture

• US 7,842,234 B2
• Filed: 06/01/2004
• Issued: 11/30/2010
• Est. Priority Date: 12/02/2002
• Status: Active Grant

• Current Assignee: Siemens Healthcare Diagnostics Incorporated (Siemens AG)
• Original Assignee: Epocal Incorporated (Siemens AG)
• Inventors: Maczuszenko, Andrzej, Lauks, Imants
• Primary Examiner(s): Noguerola; Alex
• Assistant Examiner(s): Dam; Dustin Q
• Application Number:
  US10/856,782
• Publication Number:
  US 20040222091A1
• Time in Patent Office: 2,373 Days
• Field of Search: 204/400, 204/403.01, 204/403.02, 422/50
• US Class Current: 422/50
• 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. 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 chamber defined in the card body outside the sensor region for containing a fluid and including separate fill and vent openings for filling of the chamber with a fluid without pressurization;

a fluid conduit for fluidically connecting the chamber with the sensor region, the chamber being sealed from the fluid conduit;

a valve located within the sealed chamber for opening the sealed chamber to fluidically connect the chamber to the fluid conduit without pressurization of the chamber; and

a delivery structure separate and distinct from and operable independent of the valve for forcing fluid out of the chamber and into the fluid conduit, when the chamber contains fluid and when the chamber is fluidically connected to the fluid conduit by the valve.

2. The diagnostic card of claim 1, wherein the chamber is filled with fluid and the fill and vent openings are sealed to completely seal off the filled chamber.

3. The diagnostic card of claim 2, 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 and the fill and vent openings are sealed by a second heat seal made by melt bonding the plastic coatings of the laminations about the fill and vent openings.

4. 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 chamber defined in the card body outside the sensor region for containing a fluid;

a fluid conduit for fluidically connecting the chamber with the sensor region, the chamber being sealed from the fluid conduit;

a valve located within the sealed chamber for opening the sealed chamber to fluidically connect the chamber to the fluid conduit without pressurization of the chamber; and

a delivery structure separate and distinct from and operable independent of the valve for forcing fluid out of the chamber and into the fluid conduit, when the chamber contains fluid and when the chamber is fluidically connected to the fluid conduit by the valve, wherein the chamber is made of a pair of opposed, plastic coated metal foil laminations defining the chamber wall and bonded about their perimeter by a first heat seal achieved by melt bonding the plastic coatings of the laminations about their perimeter, the card body further including a fill opening in communication with the chamber through one of the laminations for filling of the chamber with a fluid; and

a vent opening remote from the fill opening and in communication with the chamber through one of the laminations for venting of air in the chamber during filling of the chamber with the fluid, the fill and vent openings being sealable for complete sealing of the chamber by a second heat seal melt bonding the plastic coatings about the fill and vent openings.