# US 9,753,003 B2 · Diagnostic devices incorporating fluidics and methods of manufacture > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 9,753,003 B2 - Document ID: US9753003B2 - Status: Granted - Kind: B2 - Application number: 13/923,845 - Filed: 2013-06-21 - Published: 2013-10-24 - Granted: 2017-09-05 - Earliest claimed: 2002-12-02 - Assignees: Epocal Inc. - Applicants: Epocal Inc. - Inventors: Imants Lauks; Andrzej Maczuszenko - Web page: https://patentgrep.com/patent/US9753003B2 ## CPC - G01N 27/26: by investigating electrochemical variables; by using electrolysis or electrophoresis - B01L 3/502707: {characterised by the manufacture of the container or its components} - B01L 3/502715: {characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces} - B01L 3/502723: {characterised by venting arrangements} - B01L 3/50273: {characterised by the means or forces applied to move the fluids} - B01L 3/502738: {characterised by integrated valves (throttle valves in microfluidic sample containers B01L3/502746)} - B32B 37/06: characterised by the heating method - B32B 37/10: characterised by the pressing technique, e.g. using action of vacuum or fluid pressure - B32B 38/04: Punching, slitting or perforating - G01N 27/3272: {Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels (optical biosensors G01N33/52)} - G01N 27/3274: {Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration (coding of calibration information G01N33/48771)} - G01N 27/403: Cells and electrode assemblies - B01L 7/00: Heating or cooling apparatus (autoclaves B01J3/04); Heat insulating devices - B01L 2200/025: Align devices or objects to ensure defined positions relative to each other - B01L 2200/0689: Sealing - B01L 2200/148: Specific details about calibrations - B01L 2200/16: Reagents, handling or storing thereof - B01L 2300/0645: Electrodes - B01L 2300/0816: Cards, e.g. flat sample carriers usually with flow in two horizontal directions - B01L 2300/0887: Laminated structure - B01L 2300/1805: Conductive heating, heat from thermostatted solids is conducted to receptacles, e.g. heating plates, blocks - B01L 2300/1827: using resistive heater - B01L 2400/0481: squeezing of channels or chambers - B01L 2400/0487: fluid pressure, pneumatics - B01L 2400/0683: mechanically breaking a wall or membrane within a channel or chamber - B32B 2038/047: {Perforating} - B32B 2425/00: Cards, e.g. identity cards, credit cards - G01N 2021/0193: {the sample being taken from a stream or flow to the measurement cell} - G01N 2021/7756: {Sensor type} - G01N 2035/00148: {Test cards, e.g. Biomerieux or McDonnel multiwell test cards} - G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q) - B01L: CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE - B32B: LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM ## 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 ### Claim 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. ### Claim 2 (depends on 1) 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. ### Claim 3 (depends on 2) The diagnostic card of claim 2, wherein the heat seal has a width of at least 3 mm. ### Claim 4 (depends on 2) 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. ### Claim 5 (depends on 2) 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. ### Claim 6 (depends on 1) 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. ### Claim 7 (depends on 1) 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. ### Claim 8 (depends on 1) 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. ### Claim 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. ### Claim 10 (depends on 9) 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. ### Claim 11 (depends on 10) 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. ### Claim 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. ### Claim 13 (depends on 12) 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. ### Claim 14 (depends on 13) 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. ### Claim 15 (depends on 14) The diagnostic card of claim 14, wherein the heat seal has a width of at least 3 mm. ### Claim 16 (depends on 13) 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. ### Claim 17 (depends on 13) 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. ### Claim 18 (depends on 17) 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. ### Claim 19 (depends on 18) 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.