DIAGNOSTIC DEVICES INCORPORATING FLUIDICS AND METHODS OF MANUFACTURE

• US 20180038818A1
• Filed: 06/30/2017
• Published: 02/08/2018
• 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
• Granted Patent: US 10,436,735 B2
• Time in Patent Office: 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 analyses. 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 method of forming a sealed fluid reservoir in a diagnostic card, comprising the steps of obtaining a diagnostic card body with a reservoir recess in a surface of the card body;

lining the recess with a first laminate of a plastic film layer and an aluminum foil layer, the foil layer contacting the card body and the first laminate extending beyond the recess;

placing a second laminate of a plastic film layer and an aluminum foil layer over the first laminate so that the plastic film layers contact one another; and

forming a sealed reservoir by heat bonding the film layers along a periphery of the first and second laminates forming a continuous heat bond line.

2. The method of claim 1, wherein the first laminate is pressure formed into the recess to closely follow a contour of the recess.

3. The method of claim 1, wherein the heat bond line has a minimum transverse width of 3 mm.

4. The method of claim 1, wherein the recess includes a filler passage and a vent passage and the method includes the additional steps of perforating the first laminate over the filler and vent passages to form filler and vent openings therein, filling the sealed reservoir after heat bonding of the film layers by injecting fluid through the filler opening, and sealing the reservoir by forming a second heat bond of the film layers about the filler and vent openings.

5. The method of claim 2, comprising the further step of, prior to placement of the second laminate, placing a rupture plug on the first laminate at a desired location of rupture so that the rupture plug is contained in the reservoir after heat bonding of the film layers.

6. The method of claim 5, wherein the card body includes a plug receiving bore, the first laminate is pressure formed into the recess to closely follow a contour of the recess and the plug receiving bore, the plug is shaped and sized to slidably fit into the plug receiving bore, and the plug is placed at the location of the plug receiving bore prior to placement of the second laminate.

7. A diagnostic card reader for use with a diagnostic card having substantially planar opposite first and second surfaces, a measuring region and an electrode module located in the measuring region and having a conductor layer exposed in the first surface, the conductor layer being divided into a substantially central sensing region, a substantially peripheral contacting region including electrode contact ends, and an intermediate heating region surrounding the sensing region and including a heater contact element, the card reader comprising:

a housing;

a card cavity for receiving at least a portion of the diagnostic card to locate the conductor layer of the electrode module inside the card cavity;

a contacting arrangement for electrically contacting at least one of the electrode contact ends of the electrode module when the card is received in the card cavity; and

a first heater block for heating the sensing region of the electrode module when the card is received in the card cavity, the heater block having a first block portion for physically contacting the heater contact element of the electrode module and heating the heating region by direct thermal conduction, and a second block portion backset from the first portion to be spaced apart parallel to the sensing region of the electrode module when the first block portion is in physical contact with the heater contact element for heating the sensing region by indirect thermal transfer.

8. The card reader of claim 7, wherein the contacting arrangement includes at least one metal contacting element in the form of a formed metal film carried on a flex substrate mounted on a flexible support in the card reader'"'"'s card insertion orifice for resiliently contacting the contact end when the card is received in the card cavity.

9. The card reader as defined in claim 7, further comprising a second heater block for physically contacting the second surface of the card in the measuring region for heating at least the portion of the measuring region which coincides with the sensing region of the card and for heating any liquid within the card in the measuring region.

10. The card reader as defined in claim 9, wherein the heater block extends beyond the measuring region for heating fluid in any conduits in the card leading to and from the measuring region.