WO2012057712A2 - On-chip laboratory for blood analysis - Google Patents

On-chip laboratory for blood analysis Download PDF

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Publication number
WO2012057712A2
WO2012057712A2 PCT/SG2011/000381 SG2011000381W WO2012057712A2 WO 2012057712 A2 WO2012057712 A2 WO 2012057712A2 SG 2011000381 W SG2011000381 W SG 2011000381W WO 2012057712 A2 WO2012057712 A2 WO 2012057712A2
Authority
WO
WIPO (PCT)
Prior art keywords
cartridge
reservoir
chemical reagent
analyte
fluid
Prior art date
Application number
PCT/SG2011/000381
Other languages
French (fr)
Other versions
WO2012057712A3 (en
Inventor
Mehdi Khaled
Original Assignee
E-Vitae Pte. Ltd.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by E-Vitae Pte. Ltd. filed Critical E-Vitae Pte. Ltd.
Publication of WO2012057712A2 publication Critical patent/WO2012057712A2/en
Publication of WO2012057712A3 publication Critical patent/WO2012057712A3/en

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Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5027Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/54Labware with identification means
    • B01L3/545Labware with identification means for laboratory containers
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483Physical analysis of biological material
    • G01N33/487Physical analysis of biological material of liquid biological material
    • G01N33/49Blood
    • G01N33/492Determining multiple analytes
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/40ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/60ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
    • G16H10/65ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records stored on portable record carriers, e.g. on smartcards, RFID tags or CD
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/02Identification, exchange or storage of information
    • B01L2300/024Storing results with means integrated into the container
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/06Auxiliary integrated devices, integrated components
    • B01L2300/0627Sensor or part of a sensor is integrated
    • B01L2300/0645Electrodes
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/08Geometry, shape and general structure
    • B01L2300/0809Geometry, shape and general structure rectangular shaped
    • B01L2300/0816Cards, e.g. flat sample carriers usually with flow in two horizontal directions
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L9/00Supporting devices; Holding devices
    • B01L9/52Supports specially adapted for flat sample carriers, e.g. for plates, slides, chips
    • B01L9/527Supports specially adapted for flat sample carriers, e.g. for plates, slides, chips for microfluidic devices, e.g. used for lab-on-a-chip

Definitions

  • the present application relates to an on-chip laboratory for blood analysis.
  • the present application also relates to a method of using the on-chip laboratory for blood analysis.
  • On-chip laboratories include devices for metering, measuring, and/or mixing liquid samples with chemical reagents, moving the mixtures into an integrated, temperature controlled reac- tion chamber, separating compositions, and/or determining results of the mixtures with an on-board biosensor. Cost associated with development and deployment of the known on-chip laboratories is prohibitive.
  • the present application provides an on-chip laboratory that comprises an analysis cartridge having biosensors, a fluidic actuator coupled to the analysis cartridge for distributing analyte- fluids to biosensors, and an analyzer base connected to the analysis cartridge.
  • the on-chip laboratory further comprises a universal interface for connecting the analysis cartridge to the analyzer base such that the analysis cartridge is interchangeable.
  • the universal interface comprises mechanical features that assemble the analysis cartridge and the analyzer base together.
  • the universal interface further allows the analysis cartridge and the analyzer base to be taken apart so that a new analysis cartridge can be attached to the analyzer base.
  • the analysis cartridge thus becomes detachable to the analyzer base.
  • the universal interface also provides electrical connections between the analysis cartridge and the analyzer base such that the analysis cartridge and the analyzer base can be electrically coupled for performing tests.
  • a used analysis cartridge can be removed from the analyzer base so that on-chip laboratory is replaced with a new analysis cartridge for fresh analyses.
  • the new analysis cartridge shares the same electrical terminals on the analyzer base even if the new analysis cartridge has biosensors that are different from the original analysis cartridge.
  • the universal interface can comprises a common data exchange format or/and common communication protocols so that computing software for acquiring and analyzing becomes more general for the wide variety of sensors and analysis types.
  • the universal interface comprises a socket on the analyzer base and a plug on the analysis cartridge.
  • the universal interface also comprises electrical terminals on the socket and on the plug with predetermined dimensions, locations and electrical ratings.
  • the universal interface can be provided by any part of the on-chip laboratory so that other parts of the on-chip laboratory can be reused for cost-effective analyses.
  • the on-chip laboratory having the universal interface is provided for a wide variety of biosensors because many analysis cartridges with diversified biosensors can share the same universal interface for connecting to the analyze base.
  • the on-chip laboratory can provide a common mechanical, electronic and computing platform for many different analyses and different biosensors. Cost of development and deployment of mechanical, electronic and computing platforms for catering different biosensors is much reduced.
  • the universal interface also provides users with ease of daily operation, instead of keeping upgrading or learning new applications associated with biosensors of new types, from different manufacturers or having improved accuracies. Inventories and logistic effort 1
  • the biosensors can comprise different types.
  • the biosensors include photometric type of biosensors that are optical biosensors based on the phenomenon of surface plasmon resonance using evanescent wave techniques.
  • the biosensors also include electrochemical biosensors that are based on enzymatic catalysis of a reaction for producing or consuming electrons.
  • the enzymes are redox enzymes.
  • the biosensors further include piezoelectric sensors that utilize crystals undergoing an elastic deformation when an electrical potential is applied to them.
  • each one of the different types of biosensors can be used for different purposes of analyses, possibly for the same analyte fluid.
  • the electrochemical type of biosensor can be used for glucose monitoring in diabetes patients; routine analytical measurement of folic acid, biotin, vitamin B12 and pantothenic acid; and detection of pathogens.
  • the same type of biosensors can include different kinds of biosensors.
  • the electrochemical type of biosensor can include ECG biosensor or glucose biosensor.
  • the analysis cartridge can have biosensors of different types for different purposes of analyses.
  • the analysis cartridge provides a common stage that many types, kinds and numbers of biosensor can be integrated for analyzing the analyte fluid at the same time. Savings from time and material can greatly benefit manufacturers, users such as hospitals and doctors, and patients in bring better medical care.
  • the analysis cartridge can comprise a sample reservoir and chemical reagent reservoirs for containing the analyte fluids.
  • the sample reservoir can be in the form of multiple reservoirs that are connected by fluidic channels or disconnect- ed.
  • the chemical reagent reservoirs can be connected or disconnected to each other, or in the form of a single reservoir.
  • the analysis cartridge with the sample reservoir and the chemical reagent reservoirs does not require additional containers for carrying the analyte fluids and can further be discarded once used. Errors and contaminations during analysis can be avoided.
  • the fluid actuator may comprise a sample actuator and a chemical reagent actuator. Separating the fluid actuator into two parts enables the function of having two-stage fluid release.
  • the chemical reagent actuator can be firstly triggered for discharging chemical reagents for biosensor calibration. Subsequently, the sample actuator can be set off for expelling sample fluid. The expelled sample fluid is later mixed with the chemical reagent for analyzing. Measurement accuracy of the on-chip laboratory is improved.
  • the analysis cartridge can further comprise waste reservoirs that are connected to the sample reservoir and the chemical reagent reservoirs via fluidic paths.
  • the waste reservoirs are empty before the activation of the fluid actuator.
  • the biosensors can be provided at the waste reservoirs.
  • the on-chip laboratory does not have to provide bio- sensors at every reservoir so that the complexity and cost of the analysis cartridge is reduced. Separating the biosensors from the sample reservoir and the chemical reagent reservoirs also provide flexibility in designing analysis scheme or flu- idic paths.
  • the analysis cartridge further can comprise a heater for warming up the . analyte fluids.
  • Some analyses of the body fluids are temperature dependent, including blood samples.
  • the heater provides a tool for maintaining analyte fluids temperatures for accurate data acquisition.
  • the analysis cartridge can further comprise temperature sensors for monitoring temperatures of the analyte fluids .
  • the temperature sensors can provide temperature readings for compensating or correcting analyses results.
  • the temperature sensors can further be used for controlling the heater during analyses .
  • the analyzer base comprises a Subscriber Identity Module
  • SIM subscriber Identity
  • the SIM card module enables the on-chip laboratory to check identity information so that only authorized user can access and operate the on-chip laboratory. A manufacturer of the on-chip laboratory can preclude others from using the on-chip laboratory to ensure his financial return based on the device.
  • the SIM card can also prevent unauthorized persons accessing sensitive proprietary data or medical records.
  • the SIM card may further memory for storing data on other personal details, operation manuals, , parameter settings, or doctors information.
  • the application can provide a personal health hub that comprises the on-chip laboratory, a personal computer for con- necting to the on-chip laboratory, and a Personal health card readable by the personal computer for editing analyses results on the Personal health card.
  • the Personal health card is data storage memory card that is readable by computing de- vices.
  • the Personal health card can be a smart card that is accessible by a multi-card reader of a personal computer (PC) .
  • PC personal computer
  • a patient or his family doctor can keep the Personal health card for storing personal medical records.
  • the Personal health card can be updated with new analyses re- suits from the on-chip laboratory.
  • the stored results can further edited, retrieved or shared by other medical professionals for helping a patient with the Personal health card.
  • a method of assembling an on-chip laboratory comprising the steps of providing an analyzer . base, inserting an analysis cartridge onto the analyzer base, dosing analyte fluids onto the analysis cartridge, mounting a fluidic actuator, and replacing the analysis cartridge with a new analysis cartridge for resuming a fresh analysis.
  • a used analysis cartridge is replaced with a new analysis cartridge so that new analyses can be carried out.
  • the analyzer base is preserved for connecting both the used and the new analysis cartridge.
  • Equipment that connects the analyzer base for data acquisition and displaying are not changed when using both the analysis cartridges. Further changes of software are also avoided.
  • the analyzer base becomes universal for analysis cartridges, regardless the number or types of biosensors installed on the analysis cartridge .
  • the membrane seals analyte fluids in the analysis cartridge so that an analyte fluids carrying analysis cartridge can be transported or stored without the risk of con- tamination.
  • the membrane can further be transparent so that visual observation and optical analysis can be performed with the least disturbance to the cartridge.
  • the membrane can be made of low cost plastic materials, such as low-density polyethylene (LDPE) for reducing overall cost of using the on- chip laboratory.
  • LDPE low-density polyethylene
  • a method of using an on-chip laboratory comprising the steps of assembling an on- chip laboratory with an analysis cartridge, initializing the on-chip laboratory, activating the on-chip laboratory, acquiring data of the on-chip laboratory, and replacing the analysis cartridge with a new analysis cartridge for fresh analyses.
  • the initializing step can be starting up a software program on a PC and a firmware on the on-chip laboratory, while the PC is connected to the on-chip laboratory.
  • the activating step can be releasing any one of the analyte fluids for biosensor calibration and other analyses.
  • the activating step comprises inserting plungers into reservoirs of the analyte fluids in order to displace them and forcing them into desired analyzing site known as waste reservoirs.
  • the activating can be performed by turning on and off certain valves for distributing the analyte fluids.
  • the step of acquiring data can involve using electronic hardware, firmware and software.
  • the data of spe- cific interest are generated by biosensors in relation to the analyte fluids.
  • the step of replacing the analysis cartridge avoids changing the whole on-chip laboratory totally. In fact, the number of parts for the replacing can be minimized and only restricted to the parts in physical contact with the analyte fluids. Remaining parts of the on-chip laboratory are preserved so that a fresh analysis cartridge can just be inserted and resume a new of analysis. In this case, substan- tial amount of saving can be realized by reusing the remaining parts.
  • the acquiring data of the on-chip laboratory can comprise acquiring data for analyses of different purposes.
  • analyses for the same analyte fluids, there are many purposes of analyses that can be carried out simultaneously, whether using the same type or kind of biosensors.
  • the same blood sample can be examined for sodium, potassium, blood urea nitrogen, urea, creatinine, glucose, and glycosylated hemoglobin. This method can greatly improve efficiency of the data acquisition.
  • acquired data can be scrutinized for counter-check their values to ensure accuracy and reliability.
  • the present application also provides a method of using a personal health hub that comprises the steps of connecting the personal health hub and replacing the analysis cartridge with a new analysis cartridge.
  • the personal health hub can be portable and connected to any other PC with suitable software. As a result, the personal health hub can either be used in a doctor's office or a patient's home with convenience.
  • the step of replacing the analysis cartridge is specially advantages because there can be no need in having new software, new firmware, new hardware electronics and new training for users just because of having a new analysis cartridge with new biosensors. Substantial amount of saving in manpower and material cost can be achieved.
  • the personal health hub or the on-chip laboratory has the flexibility of accepting new biosensors on the analysis cartridge with the same universal interface.
  • the application provides a medical laboratory.
  • the laboratory comprises a portable casing.
  • the portable casing comprises a tray unit, an actuator unit, an analyzer unit, and a communication unit.
  • the tray unit is used for receiving a cartridge.
  • the cartridge comprises an analyte reservoir for receiving an analyte fluid, one or more chemical reagent reservoirs for storing one or more chemical reagent fluids, and one or more channels connecting the chemical reagent reservoirs with the analyte reservoir.
  • the analyte fluid can include blood, urine, salvia, and feces.
  • the channel comprises a measurement area whilst the measurement area comprises a sensor.
  • the actuator unit is used for reducing the volume of the analyte reservoir to drive the analyte fluid to fill the channels.
  • the actuator unit is also used for reducing the volume of the chemical reagent reservoirs to drive the chemical reagent fluids to fill the channels such that the analyte fluid mixes with the chemical reagent fluids to form one or more mixtures .
  • the analyzer unit is used for measuring a physical value in the measurement area using the sensor to measure the mixture
  • the analyzer unit can have a processor to determine a result of the analyte fluid using the measured values.
  • the communication unit is used for outputting the physical value.
  • the portable casing has an advantage of allowing analysis of the analyte fluid to be done outdoor. This is especially important in remote areas. Furthermore, the actuator unit ena- bles the mixtures to be formed within the portable casing without requiring much user skill.
  • the measurement area can comprise a mixture reservoir. This allows the mixtures of the chemical reagent fluids and the analyte fluid to collect or gather for easier measurement.
  • the actuator unit can comprise an analyte actuator and a chemical reagent actuator. This allows separate volume of the respective fluids, which is needed in certain situations.
  • the actuator unit can comprise a push area, such as a push button> for manual actuation by a user of the laboratory.
  • the manual can allow the laboratory to be simple and of low cost.
  • the tray can be provided as a movable, such as a slidable tray. The moveable tray enables a easy receiving of the cartridge.
  • the cartridge further comprises one or more waste analyte reservoirs and one or more chemical waste reservoir.
  • the waste analyte reservoirs and the chemical reagent waste reservoirs are connected to the analyte reservoir and to the chemical reagent reservoirs via the fluid channels.
  • the waste analyte reservoirs can receive the excess an- alyte fluid whilst the chemical waste reservoir can receive the excess chemical reagent.
  • the cartridge can include a heater for heating the analyte fluid and it can include a temperature sensor for monitoring a temperature of the analyte fluid. For certain analysis, the analyte fluid needs to be heated.
  • the communication unit can include a Subscriber Identity Module (SIM) card interface. This allows the result to be out- putted via a wireless means.
  • SIM Subscriber Identity Module
  • the application provides a personal health hub.
  • the personal health hub includes the above laboratory, a computing device connecting to the laboratory, and a device accessible by the computing device for storing one or more results of the laboratory.
  • the application provides a method of using a portable laboratory.
  • the method comprises a step of a cartridge receiving a analyte fluid.
  • the cartridge is then placed inside a portable casing for analyzing the analyte fluid.
  • the analysis includes a step of an actuator unit of the casing driving the analyte fluid to fill a part of one or more fluid channels and driving one or more chemical reagent fluids to fill a part of one or more fluid channels.
  • the filling is done such that the analyte fluid mixes with the chemical reagent fluids to form one or more mixtures.
  • One or more sensors of the casing later measure one or more values of the mixtures.
  • a processor of the casing afterward determines a result of the analyte fluid using the measured values.
  • a com- munication unit of the casing then outputs the result.
  • the method can include a step of heating any one of the analyte fluid and the chemical reagent fluids.
  • the analysis can include a step of measuring temperature of the analyte fluid. Theses step are required for certain analysis of the analyte fluid.
  • the result also can be outputted to one or more LED lights or to an external computing device for communicating the result to a user.
  • the application provides a cartridge for a portable laborato- ry.
  • the cartridge comprises an analyte reservoir, one or more chemical reagent reservoirs, one or more fluid channels, a first contact area, and a second contact area.
  • the analyte reservoir is used for receiving an analyte fluid.
  • the chemical reagent reservoirs are used for storing the chemical reagent fluids.
  • The. channels are used for connecting the chemical reagent reservoirs with the analyte reservoir.
  • the channels comprise measurement areas.
  • the measurement areas comprise sensors for measuring physical values in the measurement areas and electrical contacts for accessing the sensors.
  • the first contact area is placed in the vicinity of the analyte reservoir.
  • the first contact area is provided for con- tacting with an actuator unit for reducing the volume of the analyte reservoir to drive the analyte fluid to fill the channels.
  • the second contact area is placed in the vicinity of the chemical reagent reservoir.
  • the second contact area is provided for contacting with the actuator unit for reducing the volume of the chemical reagent reservoirs to drive the chemical reagent fluids to fill the channels such that the analyte fluid mixes with the chemical reagent fluids to form one or more mixtures .
  • the measurement area often includes a mixture reservoir. The mixture reservoir allows a gathering of the fluid mixture for easier measurement.
  • the cartridge can comprise one or more waste analyte reservoirs and one or more chemical waste reservoirs.
  • the waste analyte reservoirs and the chemical reagent waste reservoirs are connected to the analyte reservoir and to the chemical reagent reservoirs via the fluid channels.
  • the waste analyte reservoirs and the chemical reagent waste reservoirs can be used to store excess fluids.
  • the cartridge can comprise a heater in the vicinity of the analyte reservoir for heating the analyte fluid. This is required for certain analysis.
  • the cartridge can comprise a temperature sensor in the vicinity of the analyte reservoir for monitoring a temperature of the analyte fluid. This is also required for certain analysis.
  • the combination of heater and temperature sensors can provide a temperature control, which may be used for controlling reaction between the analyte fluid and a chemical reagent.
  • the reaction often follows the Arrhenius law or equation and is directly dependent of temperature.
  • reaction rate For a chemical reaction where substance A and B are reacting to produce C, the reaction rate has the form:
  • [C] is the concentration of substance C in moles per volume of solution assuming the reaction is taking place throughout the volume of the solution (for a reaction taking place at a boundary it would denote something like moles of C per area).
  • the exponents "m” and "n” are called orders and they depend on the reaction mechanism and can be determined experimental- ly.
  • the module of heater and temperature sensors inserted in a sensor cartridge boosts a collection of electrical cur- rent on the electrodes for better response time and precision. This can be achieved for example by increasing the temperature from about 37 to about 50 Celsius. This property also allows use of smaller blood sample size for analysis.
  • the application provides a laboratory with cartridge date.
  • the laboratory comprises a portable casing, a memory device reader, an actuator unit, an analyzer unit, and a communication unit.
  • the portable casing includes a tray unit for receiving a cartridge in which the cartridge comprises a plurality of reservoirs and a memory device.
  • the plurality of reservoirs includes an analyte reservoir, at least one chemical reagent reservoir, and at least one channel.
  • the analyte reservoir is intended for receiving an analyte fluid, such as a blood sample.
  • the chemical reagent reservoir is intended for storing a chemical reagent fluid for mixing with the analyte fluid.
  • the channel connects the chem- ical reagent reservoir with the analyte reservoir to provide a fluidic passage between the chemical reagent reservoir and the analyte reservoir.
  • the channel also comprises a measurement area, wherein the measurement area comprises a sensor.
  • the memory device includes cartridge data that includes sen- sor data.
  • the actuator unit is intended for interacting with the cartridge such that the volume of the analyte reservoir and the volume of the at . least one chemical reagent reservoir is reduced.
  • the analyzer unit is intended for interacting with the cartridge such that a physical value in the measurement area is measured using the sensor in accordance to the cartridge data.
  • the communication unit is intended for out- putting the physical value.
  • the cartridge data allows a user to operate the cartridge in a manner that is intended by its manufacturers.
  • the cartridge data can be encrypted such that only devices with the appropriate decryption key can use the cartridge.
  • the actuator unit can be adapted for interacting with the cartridge such that the volume of the analyte reservoir and the volume of the at least one chemical reagent reservoir are reduced in accordance to the cartridge data.
  • the actuator unit can comprise an analyte actuator for interacting with the cartridge such that the volume of the analyte reservoir is reduced.
  • the actuator unit can also comprise a chemical reagent actuator for interacting with the cartridge such that the volume of the at least one chemical reagent reservoir is reduced.
  • the application provides a laboratory that comprises a porta- ble casing.
  • the portable casing includes a tray unit, an actuator unit, an analyzer unit, and a communication unit.
  • the tray unit it is used for receiving a cartridge, wherein the cartridge comprises a plurality of reser- voirs.
  • the plurality of reservoirs includes an analyte reservoir, a first chemical reagent reservoir together with a second chemical reagent reservoir, a first mixture reservoir, a second chemical reagent reservoir, and a second mixture reservoir.
  • the analyte reservoir is used for receiving an analyte fluid.
  • the first and the second chemical reagent reservoirs are used for storing a first chemical reagent fluid and a second chemical reagent fluid respectively.
  • the first mixture reservoir is used for receiving the analyte fluid from the analyte reservoir with the first chemical reagent fluid from the first chemical reagent reservoir via a first channel network.
  • the second mixture reservoir is used for receiving the analyte fluid with the first chemical reagent fluid from the first mixture reservoir and the second chemical reagent fluid from the second chemical reagent reservoir via a second channel network.
  • the second channel network comprises a measurement area in which the measurement area comprises a sensor.
  • the actuator unit it is used for interacting with the cartridge such that the volume of the analyte reservoir, the volume of the first chemical reagent reservoir with the second chemical reagent reservoir, and the volume of the first mixture reservoir are reduced.
  • the analyzer unit is used for interacting with the cartridge such that a physical value in the measurement area is measured using the sensor.
  • the communication unit is used for outputting the physical value.
  • the first channel network can comprise a measurement area that includes a sensor in which the analyzer unit interacts with the cartridge such that a physical value in the measurement area is measured using the sensor.
  • the portable casing can have a memory device reader for retrieving cartridge data from a memory device of the cartridge.
  • the analyzer unit then interacts with the cartridge such that the physical value in the measurement area is measured using the sensor in accordance to the cartridge data.
  • the actuator unit can be adapted for interacting with the cartridge such that the volume of the analyte reservoir, the volume of the first chemical reagent reservoir and the volume of the second chemical reagent reservoir, and the volume of the first mixture reservoir are reduced in accordance to the cartridge data.
  • the actuator unit comprises an analyte actuator, a chemical reagent actuator, and a mixture reservoir actuator.
  • the analyte actuator is used for interacting with the cartridge such that the volume of the analyte reservoir is reduced.
  • the chemical reagent actuator is used for interacting with the cartridge such that the volume of the first chemical reagent reservoir and the volume of the second chemical reagent reservoir are reduced.
  • the mixture reservoir actuator is used for interacting with the cartridge such that the volume of the first mixture reservoir is reduced.
  • the actuator unit can comprise one or more push areas for manual actuation by a user of the laboratory.
  • the tray can be provided as a movable tray.
  • the communication unit can comprise a Subscriber Identity Module (SIM) card interface for easy implementation.
  • SIM Subscriber Identity Module
  • the application provides a personal health hub.
  • the personal health hub comprises the abovementioned laboratory, a computing device, and a device.
  • the computing device connects to the laboratory for retrieving one or more results of the laboratory.
  • the device is . accessible by the computing device for storing the results of the laboratory.
  • the application provides a method of using a portable laboratory with cartridge data.
  • the method includes a step of storing cartridge data in a memory device of a cartridge. Put differently, the cartridge data is stored in the cartridge.
  • the cartridge is then provided with an analyte fluid.
  • the analyte fluid can be obtained from a patient or a living being. After this, the car- tridge is placed in a portable casing of the portable laboratory for analyzing the analyte fluid.
  • the analysis includes a step of retrieving the cartridge data from the memory device of the cartridge by a memory device reader of the portable casing. This allows the laboratory to use the cartridge data to operate the cartridge.
  • the analyte fluid is later driven using an actuator to fill one or more channels.
  • One or more chemical reagent fluids are also driven to fill the channel.
  • the driving is done such that the analyte fluid mixes with the chemical reagent fluid to form a mixture.
  • One or more values of the mixture are afterward measured in a way that is in accordance to the cartridge data. Following this, a result of the analyte fluid is deter-. mined using the measured values. The result is then output- ted.
  • the analyte fluid can be driven to fill the channel and the chemical reagent fluid is driven to fill the channel in a manner that is in accordance to the cartridge data .
  • the application provides a method of using a portable laboratory.
  • the method allows a test sample to be subjected to a series of test.
  • the method includes a step of providing the cartridge with an analyte fluid, such a blood sample.
  • the blood sample is taken for living being, such as a patient.
  • the cartridge is later placed in a casing of the portable laboratory for analyzing the analyte fluid.
  • the analysis comprises several steps of actuating fluids of the cartridge. These steps include driving the analyte fluid and a first chemical reagent fluid from a first chemical reagent reservoir to fill a first mixture reservoir such that the analyte fluid mixes with the first chemical reagent fluid to form a first mixture.
  • the first mixture and a second chemical reagent fluid are then driven to fill a second mixture reservoir such that the first mixture mixes with the second chemical reagent fluid to form a second mixture.
  • the second chemical reagent fluid is driven from a second chemical reagent reser- voir.
  • one or more values of the second mixture are measured using a sensor.
  • a result of the analyte fluid is afterward determined using the measured values.
  • the sen- sor can provide electrical current readings of a mixture. The readings are then converted to corresponding glucose values to provide, a test result of the mixture. The determination of the result is done, in this case, by the conversion of the electrical current readings.
  • the result is then outputted to a display unit, such as LED lights for displaying an "acceptable” or “unacceptable” result, or to an external . computing device for further processing .
  • a display unit such as LED lights for displaying an "acceptable” or “unacceptable” result, or to an external . computing device for further processing .
  • the step of analysis can comprise a step of measuring one or more values of the first mixture. These values can serve to as immediate verification readings.
  • the result of the analyte fluid can be determined using the measured value of the first mixture together with the measured value of the second mixture .
  • the method can further comprise a step of storing cartridge data in a memory device of a cartridge. The cartridge data is later retrieved from the memory device of the cartridge by a memory device reader of the portable casing. One or more values of the first or of the second mixture are then measured in accordance to the cartridge data.
  • the analyte fluid together with the first chemical reagent fluid can be driven to fill a first mixture reservoir in a manner that is in accordance to the cartridge data.
  • the first mixture together with the second chemical reagent fluid can also be driven to fill the second mixture reservoir in a manner that is in accordance to the cartridge data.
  • the analyte fluid, the first chemical reagent fluid, and the second chemical reagent fluid may be to driven at different time with different durations for different tests.
  • the; relevant data can incorporated in the cartridge data.
  • the result of the analyte fluid can then be determined using the measured value in accordance to the cartridge data.
  • the analysis can include a step of heating the analyte fluid and/or the chemical rea- gent fluid as needed. Temperature of the analyte fluid and/or the chemical reagent fluid can also be measured for temperature control purpose.
  • the result can be outputted in a variety of ways. It be out- putted to at least one LED light or to an external computing device .
  • the application provides a cartridge for a portable laboratory.
  • the cartridge itself provides data for using the cartridge.
  • the cartridge includes several reservoirs or wells with corresponding contact areas and a memory device.
  • the reservoirs include an analyte reservoir, at least one chemical reagent reservoir, and at least one channel.
  • the analyte reservoir is used for receiving an analyte fluid.
  • the chemical reagent reservoir is used for storing a chemical reagent fluid.
  • the channel connects the chemical reagent reservoir with the analyte reservoir, wherein the channel comprises a measurement area.
  • the measurement area comprises a sensor for measuring a physical value in the measurement area and electrical contacts for accessing the sensor.
  • the contact areas include an analyte contact area and at least one chemical reagent contact area.
  • the analyte contact area is positioned in the vicinity of the an- alyte reservoir and it provided for contacting with an actuator unit for reducing the volume of the analyte reservoir.
  • the chemical reagent contact area is positioned in the vicinity of the at least one. chemical reagent reservoir and it is provided for contacting with the actuator unit for reducing the volume of the chemical reagent reservoir.
  • the memory device it has cartridge data, which is used for operating the sensor. Equipped with the sensor data, the cartridge can be used easily. Using the cartridge with the incorrect cartridge data by mistake is also avoided.
  • the cartridge data can also comprise data for actuating the analyte contact area and data for actuating the least one chemical reagent contact area. These areas might be actuated differently for different analyte fluids and for different tests. Again equipping the cartridge with the said information is not only useful but also convenient for the user. For security reasons, the cartridge data can be encrypted. Thus, only devices with the necessary decrypted key may use the cartridge.
  • the application provides a cartridge for a portable laboratory.
  • the cartridge is used for processing a series of tests.
  • the tests can relate a biological organ of a living being.
  • the cartridge includes a plurality of parts for holding a plurality of fluids and a plurality corresponding areas for actuating fluids.
  • an analyte reservoir a first chemical reagent reservoir and a second chemical reagent reservoir, as well as a first mixture reser voir and a second mixture reservoir.
  • the analyte reservoir is used for receiving an analyte fluid.
  • the first chemical reagent reservoir is used for storing a first chemical reagent fluid while the second chemical reagent reservoir is used for storing a second chemical reagent fluid.
  • the first mixture reservoir is used for receiving the analyte fluid from the analyte reservoir via a first channel network.
  • the channel network includes one or more fluid passageways. It is also used for receiving the first chemical reagent fluid from the first chemical reagent reservoir via the first channel network. The analyte fluid and the first chemical reagent reservoir are received such that that they mix to form a first mixture.
  • the second mixture reservoir is used for receiving the first mixture of the analyte fluid with the first chemical reagent fluid from the first mixture reservoir via a second channel network. The second mixture reservoir is also used for receiving the second chemical reagent fluid from the second chemical reagent reservoir via the same second channel network. The first mixture and the chemical reagent fluid are received such that they mix to form a second mixture.
  • the second channel network includes a measurement area that comprises a sensor.
  • the sensor is used for measuring a physical value of the second mixture in the measurement area.
  • the second channel network also includes electrical contacts for accessing the said sensor. Referring to the plurality fluid actuating areas, it includes an analyte reservoir contact area, a first chemical reagent contact area, a second chemical reagent contact area, a first mixture reservoir contact area,
  • the analyte reservoir contact area is located in the vicinity of the analyte reservoir. It is provided for contacting with an analyte actuator for reducing the volume of the analyte reservoir .
  • the first and the second chemical reagent contact areas are located in the vicinity of the first and the second chemical reagent reservoirs respectively.
  • the cartridge is able to support a testing of the analyte fluid with more than one chemical reagent. This is different from other implementations.
  • the cartridge can include a memory device with cartridge data for using the sensor.
  • the data for using the cartridge can be placed in the cartridge that the usage and the cartridge are together. A user does not have to spend time searching for cartridge data before using the cartridge.
  • the cartridge data can also comprise data for actuating fluids within the cartridge.
  • the data includes information for the analyte contact area, the first chemical reagent contact area, the second chemical reagent contact area, and the first mixture reservoir contact area. These areas might need to be actuated in a particular sequence with a certain time period between each actuation.
  • the information can be incorporated in the cartridge data for complete teaching on the use of the cartridge. A laboratory using the cartridge simply needs to read the information when the labora- tory is using the cartridge.
  • the cartridge mentioned above can include a waste analyte reser- voir and one or more chemical waste reservoirs.
  • the waste an- alyte reservoir is connected to the analyte reservoir an ana- lyte channel while the chemical reagent waste reservoir is connected to the chemical reservoir via a chemical reagent waste channel.
  • the measurement area can include a measurement reservoir or well to collect a testing sample for easy testing or measurement .
  • the cartridge mentioned above can have a heater.
  • the heater may be located, for example, in the vicinity of the analyte reservoir.
  • the cartridge often comprises a temperature sensor to control the heater.
  • the application provides a cartridge unit for performing at least one test for a biological organ, such as a liver of human being.
  • the cartridge unit includes the cartridge men- tioned above.
  • the cartridge comprises one or more sensors.
  • the sensor measures one or more physical values of the biological organ.
  • the cartridge unit is used for obtaining results for one or more tests of a biological organ.
  • Figure 1 illustrates a schematic of an embodiment of a portable laboratory unit
  • Figure 2 illustrates a flow chart for the portable laboratory unit of Figure 1
  • FIG 3 illustrates a further flow chart for the portable laboratory unit of Figure 1
  • Figure 4 illustrates an analysis of a kidney using the portable laboratory unit of Figure 1
  • Figure 5 illustrates an analysis of a patient with a cardiac post-operation condition using the portable laboratory unit of Figure 1
  • Figure 6 illustrates a table of values of measurements of the analysis of Figures 4 and 5
  • Figure 7 illustrates a pin connection table for the portable laboratory unit of Figure 1
  • Figure 8 illustrates an exploded schematic view of another embodiment of the portable laboratory
  • Figure 9 illustrates a schematic view of an embodiment of a multi-analysis cartridge for the portable laboratory of Figure 8,
  • Figure 10 illustrates a schematic view of another embodiment of the multi-analysis cartridge for the portable laboratory of Figure 8.
  • Figure 11 illustrates an embodiment of a casing for the portable laboratory of Figure 8.
  • FIG 1 shows a schematic of a portable laboratory unit 450 for receiving an improved cartridge module 454.
  • the cartridge module 454 is also called a sensor cartridge.
  • the senor cartridge is improved to reduce cost and to improve ease of implementation.
  • the portable laboratory unit 450 includes a smart card reader 456.
  • the cartridge module 454 includes at least one monitoring sensor, which is provided as a bio-chemical sensor. Several monitoring sensors can be provided in a sensor array.
  • the cartridge module 454 also includes a smart card 458 that is inserted in a casing of the cartridge module 454.
  • the smart card 458 includes a micro-controller structure that embeds a memory device 459.
  • the memory device 459 comprises a non-volatile semiconductor memory.
  • the micro-controller structure is not shown in Figure 1.
  • the cartridge module 454 is used for receiving a biological fluid, such as whole blood or serum, from a patient.
  • the monitoring sensor relies on amperometric, potentiometric, inpedencometric, or calorimetric techniques to provide meas- urements.
  • the amperometric technique relates to a chemical titration in which the measurement of an electric current flowing under an applied potential difference between two electrodes in a solution is used.
  • the biochemical sensor refers to a chemical sensor that is used in medical diagnosis and in patient monitoring.
  • the biochemical sensor has electrochemical or optical features. It is characterized by a response curve and is operated using a measurement protocol. In one example, the response curve shows an electrical current versus concentration of species of interest relationship.
  • the measurement protocol comprises test conditions with wait times to initiate a chemical reaction for obtaining a sensor reading.
  • the non-volatile memory of the memory device 459 is used to store sensor characteristic data, sensor traceability data, as well as specific sensor measurement protocol data in a form of a software file during production of the cartridge module 454. These stored data are used to configure and to operate the monitoring sensor of the cartridge module 454.
  • the software file is provided in an XML (Extensible Mark-up Language) format for ease of meeting current and forecasted regulations on medical electronic data.
  • the microcontroller structure is used for securing and protecting the stored data of the memory device 459 with an encryption scheme such that the stored data is prevented from being copied for unauthorized use by counterfeit sensors or by sensors produced by unauthorized manufacturers.
  • the portable laboratory unit 450 is used for receiving the cartridge module 454 and for analyzing the biological fluid within the cartridge module 454.
  • the smart card reader 456 is used for reading or obtaining data stored in the memory device 459 such that the laboratory unit 450 can operate the monitoring sensors of the cartridge module 454 to obtain sensor measurements.
  • a method of using the portable laboratory unit 450 with an external computer is shown by a flow chart 465 of Figure 2.
  • the flows chart 465 shows steps of analysis for a patient with an instable coronary condition.
  • the flow chart 465 includes a step 470 of indicating for bio- analysis for a patient with coronary artery disease symptoms by a doctor. After this, the doctor selects an appropriate sensor cartridge 454 with a sensor array in a step 473.
  • the sensor array is used in this case is used for measuring Troponin, CK-MB Myoglobin, BNP/ NT-proBNP, and Prothrombin Time/INR.
  • the sensor cartridge 454 with its smart card 458 is later placed in the smart card reader 465 of the portable laboratory unit 450 in a step 476. This placing also initiates the reading of the smart card 458 by the smart card reader 465, wherein the smart card reader 465 reads instructions from the memory device 459 of the smart card 458. As directed by the read instructions, the smart card reader 465 afterward extracts information from the memory device 459 in a secured manner. The information is then downloaded into a database of a software operating system of the portable blood laboratory unit 450 to activate a sequence of checks and actions.
  • the extract information is later used by the smart card read- er 465 to check reference data for the sensor of the sensor cartridge 454 against another internal database of accepted sensor sources.
  • the reference data include brand data, distributor data, species or set of species measurement parameter data, measurement method data, lot number data, and expi- ration date data.
  • the smart card reader 465 downloads measurement protocol data for the sensor of the sensor cartridge 454 from the smart card memory in a form of instructions sets.
  • a biological fluid which is provided in a form of blood, is then drawn from a living individual for injecting into the sensor cartridge 454 in a step 479.
  • a device lid of the port- able laboratory unit 450 is later closed to initiate actuation of the biological fluid within the sensor cartridge 454 in a step 482.
  • the sensors are activated according to the instruction set downloaded by the smart card reader 465 in a step 485.
  • the instruction set provides a sequence of several measurement phases with steps to activate the sensors as well as da- tasets with relevant limits for checking elementary functionality of the sensors.
  • the sensor readings are then taken according to the above in- struction set in a step 488.
  • the instruction set also has a sequence of several measurement phases with voltage data, frequency data, and electrical current data for applying to the sensors for obtaining sensor measurements.
  • the instruction set may have instructions to repeat the measurement phases for obtaining multiple sensor measurements.
  • the multiple sensor measurements are done especially in a situation where the sensor cartridge 454 comprises a set of sensors measuring different species.
  • the read sensor reading or data are afterward compiled in a step 491.
  • the compilation includes downloading a response curve from the smart card memory for the sensor of the sensor cartridge 454 in a form of a look-up table.
  • the look-up table is later used by the smart card reader 465 to convert its electrical current or voltage measurements to meaningful readings in the form of specie or concentration with the appropriate measurement unit.
  • compiled reading is then transferred via USB protocol to a computer that is connected to the portable laboratory unit 450 in a step 494.
  • Computer software afterward analyses and displays a finding of the sensor readings in tables and/or in graphs in a step 497.
  • the compiled data are then aggregated and are saved locally in the computer in patient records in a step 500.
  • the compiled data can also be printed subsequently.
  • the compiled data can also be prepared for transferring a standard protocol, such as HL7, in a step 506.
  • the prepared data are transferred to an external device in a step 509.
  • the prepared data can be also transferred to a remote repository or to remote patient records in a step 512.
  • the prepared data can also be emailed to the patient or to an appropriate third party.
  • tests for cardiac markers to assess an acute myocardical condition needs to be conducted.
  • the myocardical condition refers to a muscular tissue of the heart.
  • An doctor can have a dedicated cartridge with relevant biosensors to perform these various tests using merely one cartridge, since the same cartridge has sensors to measure serum concentration of Troponin, CK-MB, BNP or NT-proBNP, Prothrombin Time/INR and to deliver the findings at the point of patient care.
  • testing of liver function is conducted using a dedicated cartridge, which has embedded sensors to measure Gamma-GT (Gamma-glutamyl transpeptidase), ASAT (aspartate aminotransferase) , ALAT (Alanine transaminase) , Bili- rubine and to perform a Protein Electrophoresis.
  • the electrophoresis refers to a technique used to separate different elements of a blood sample into individual components.
  • the serum protein electrophoresis (SPEP) is a screening test that measures the major blood proteins by separating them into five distinct fractions: albumin, alphal, alpha2, beta, and gamma proteins.
  • the protein electrophoresis can also be performed on urine.
  • a system of the smart card reader 456 with different cartridge modules 454 is provided below. These cartridge modules 494 are produced by different manufacturers. The cartridge modules 494 have different sensor response curves and are yet work the same smart card reader 456 since these cartridge modules 494 store its own sensor response curves.
  • parameters of the monitoring sensors are coded in a firmware of sensor reader hardware. These parameters comprise species data, responses curve data, and measurement protocol data.
  • the monitoring sensor is adapted to work only with a specific reader that has necessary sensor response curves and necessary sensor protocol for a given and often unique type of sensor unit of the monitoring sensor.
  • the portable laboratory unit 450 can be used in a standalone mode without connecting to a computer.
  • Figure 3 shows an embodiment of the flow chart 465 of Figure 2.
  • Figure 3 depicts a flow chart 520 that includes steps of the flow chart 465, wherein steps of the flow chart 465 that involves the external computer are omitted.
  • the portable laboratory unit 450 can be used to provide several tests for different conditions.
  • Figure 4 shows an example of kidney condition analysis 525 using the portable laboratory unit of Figure 1.
  • the analysis has tests or measurements for creatinine, Ph, hematocrit, glucose, BUN/Urea, chloride, potassium, and sodium. These measurements may be repeated a number of times.
  • Figure 5 shows am example of cardiac post-op condition analysis 530 using the portable laboratory unit of Figure 1.
  • the analysis has tests for B-Type Natriuretic Peptide/ BNP, Cardiac Troponin 1/ cTnl, Kaolin ACT, Prothrombin Time PT/INR, Celite Activated Clottng time, Creatinine, PC02 and, pH.
  • Figure 6 shows a table 535 of possible values for the measurements of Figures 4 and 5.
  • Figure 7 shows a pin connection table 540 for. the portable laboratory unit of Figure 1.
  • the table 540 depicts a contact- pin connection list for a sensor cartridge 454 with 40 pin, wherein
  • pins 1 to 32 are assigned for sensors, four pins being assigned to one sensor,
  • - pins 37 to 40 are assigned for temperature control and sensing.
  • the set of pins 37 to 40 is often important for precise specie analysis due to dependencies of reaction rates with temperature, which is shown by Arrhenius equation.
  • the order of sensor in the table 540 depends on the cartridge manufacturing as well as on specific species of interest. In a case of a quasi-sensor for Ph and for Hematocrit, the first set of sensors is often important for blood related analysis due to the importance of the sensitivity of the reactivity of the species of interest with pH and blood cell count.
  • the embodiment provides a single means to perform various laboratory tests for a specific human organ or a specific human function in a logical and a practical way.
  • the means uses biological fluids, which includes whole blood or serum.
  • a portable laboratory can be provided with more one chemical reagent actuator to provide additional features.
  • Figure 8 shows a portable laboratory 545 with a multi- analysis cartridge 556 for blood analysis.
  • the laboratory 545 comprises one blood sample actuator 548, two independent biosensor chemical actuators 551 and 554, and a portable base analyzer 559.
  • the blood sample actuator 548 is placed next to the biosensor chemical actuators 551 and 554 while the biosensor chemical actuators 551 and 554 are placed next to the multi-analysis cartridge 556.
  • the multi-analysis cartridge 556 is placed next to the portable base analyzer 559.
  • the portable laboratory 545 can include two or more blood sample actuators, instead of one blood sample actuator 548.
  • the portable laboratory 545 can include more than two biosensor chemical actuators and not just two biosensor chemical actuators.
  • the multi-analysis cartridge 556 provides a means to receive a blood sample.
  • the portable laboratory 545 provides a means to analyze this blood sample.
  • the cartridge 556 is used for receiving a blood sample.
  • the blood sample actuator 548 is used for providing a force from a user to the cartridge 556 for dispersing the blood sample into channels and reservoirs within the cartridge 556.
  • the biosensor chemical actuators 551 and 554 are used for transmitting a force from a user to the cartridge 556 for dispersing chemical reagents into channels and reservoirs within the cartridge 556.
  • the chemical actuators 551 and 554 are adapted to move independent of each other.
  • the chemical reagent is intended for mixing with the blood sample to a mixture, wherein the mixture is measured by a sensor.
  • the portable base analyzer 559 is used for obtaining the sensor measurements to provide a finding or a test result of the blood sample.
  • the blood sample actuator 548 and the biosensor chemical actuators 551 and 554 can be forced by an electric motor or by a hydraulic motor instead of being forced manually.
  • Figure 9 shows a first embodiment of the multi-analysis cartridge 556.
  • Figure 9 depicts a multi-analysis cartridge 565.
  • the cartridge 565 comprises a blood sample reservoir 568, a first chemical reagent reservoir 571 and a second chemical reagent reservoir 574, as well as a first waste reservoir 577 and a second waste reservoir 580.
  • the first chemical reagent reservoir 571 is connected to the first waste reservoir 577 by a channel 583 while the first waste reservoir .577 is connected to the second waste reservoir 580 by a channel 586.
  • a channel 589 connects the blood sample reservoir 568 to the channel 583.
  • a sensor 590 is placed at the intersection of the channel 583 and the channel 589.
  • a channel 592 connects the second chemical reagent reservoir 574 to the channel 586.
  • a sensor 594 is placed at the intersection of the channel 586 and the channel 592.
  • the cartridge 556 is adapted to work with the portable laboratory 545 of Figure 8, wherein the blood sample reservoir 568 is intended for actuating by the blood sample actuator 548 of Figure 8.
  • the first chemical reagent reservoir 571 and the second chemical reagent reservoir 574 are intended for actuating by the biosensor chemical actuator 554 of Figure 8.
  • the first waste reservoir 577 is intended for actuating by the biosensor chemical actuator 551 of Figure 8.
  • the blood sample reservoir 568 is used for receiving a blood sample.
  • the blood sample reservoir 568 is also used for dispersing the received blood sample into the first waste reservoir 577 via the channels 583 and 589 when it is actuated.
  • the first chemical reagent reservoir 571 is used for storing a first chemical reagent.
  • the first chemical reagent reser- voir 571 is also adapted for dispersing the first chemical reagent into the first waste reservoir 577 via the channel 583 when it is actuated.
  • the first chemical reagent is used for mixing with the blood sample such that measurements of this mixture are used to provide a finding or a test result of the blood sample.
  • the intersection of the channels 583 and 589 serves as an area where the blood sample mixes and interacts with the first chemical reagent to form a first mixture.
  • the sensor 590 is used for measuring the first mixture. The sensor measurement then acts to provide a finding or a test result of the blood sample.
  • the first waste reservoir 577 is adapted for receiving the first mixture. It is also adapted for dispersing the first mixture into the second waste reservoir 580 via the channel 586 when it is actuated.
  • the second chemical reagent reservoir 574 is used for storing a second chemical reagent. It is also used for dispersing the second chemical reagent into the second waste reservoir 580 via the channels 592 and 586 when it is actuated.
  • the intersection of the channels 586 and 592 serves as an area where the first mixture mixes or interacts with second chemical reagent to form a second mixture.
  • the sensor 594 is used for measuring the second mixture. Sensor measurements of the second mixture are used providing another finding of the blood sample.
  • the cartridge 556 can be adapted such that the blood sample can be mixed with more than two chemical reagents.
  • the portable laboratory working with the cartridge 556 can also include a heater for elevating the first mixture or the second mixture for a period.
  • the portable laboratory can also include processor to measure the first or the second mixture only after a certain period.
  • This cartridge 556 allows the blood sample to be subjected to a string of chemical reagents. In other words, the blood sample can be subjected to a process of chemical testing. This is different from other cartridge that allows a blood sample to be subjected to just. one chemical testing.
  • a method of using the cartridge 556 is provided below. The method includes a step of the blood sample reservoir 568 receiving a blood sample for a patient.
  • the cartridge 556 is then placed inside an open casing of a portable laboratory.
  • the placing initials the sensors 590 and 594 in which electrical current and/or voltage is provided to the sensors 590 and 594.
  • the portable laboratory casing is then closed.
  • the closing actuates the first chemical reagent reservoir 571 such that the first chemical reagent is dispersed into the first waste reservoir 577 via the channel 583.
  • the closing actuates the second chemical reagent reservoir 574 such that the second chemical reagent is dispersed into the second waste reservoir 580 via the channels 592 and 586.
  • a user presses a first push button of the labora- tory casing. This pressing actuates the blood sample reservoir 568 such that the blood sample within the blood sample reservoir 568 is dispersed into the first waste reservoir 577 via the channels 589 and 583.
  • the dispersed blood sample also mixes with the first chemical reagent within the channel 583 and the first waste reservoir 577 to form the first mixture.
  • the sensor 590 measures, the first mixture to provide a finding.
  • the dispersed mixture further mixes with the second chemical agent to form the second mixture.
  • the sensor 594 measures the second mixture to provide another finding.
  • a user uses the findings to treat the patient that provides the blood sample.
  • Figure 10 shows a second embodiment of the multi-analysis cartridge 556 of Figure 9.
  • Figure 10 depicts a multi-analysis cartridge 600 that has all parts of the , multi-analysis cartridge 565 of Figure 9, where- " in the channel 589 of the cartridge 600 is connected directly to the blood sample reservoir 568 and to the first waste reservoir 577.
  • the sensor 590 is placed inside the first waste reservoir 577.
  • the channel 592 is connected directly to the second chemical reagent reservoir 574 and to the second waste reservoir 580.
  • the sensor 594 is placed inside the second waste reservoir 580.
  • Figure 11 shows an embodiment of a casing for the portable laboratory of Figure 8.
  • Figure 11 depicts a portable laboratory casing 610 with a cover 615.
  • the casing 610 has a slidable tray 620.
  • the cover 615 has two push buttons 624 and 627 with two corresponding groups 630 and 633 of LED (Light Emitting Diode) light bulbs.
  • LED Light Emitting Diode
  • the tray 620 is used for receiving a cartridge with a blood sample.
  • the cover 615 is used for actuating chemical reagent reservoirs of the received cartridge to disperse a first chemical reagent and a second chemical reagent.
  • the first group 630 of LED is used for prompting a user to press the push button 624.
  • the pressed push button 624 actuates a blood sample reservoir of the cartridge to disperse blood sample within the blood sample reservoir to mix with the first chemical reagent.
  • the second group 633 of LED is used for prompting the user to press the push button 627.
  • the pressed push but- ton 627 then actuates a reservoir of the cartridge to disperse the mixture of the blood sample and the chemical reagent to mix with the second chemical reagent .
  • a laboratory comprising a portable casing, the portable casing comprising
  • a tray unit for receiving a cartridge, the cartridge comprising .
  • an analyte reservoir for receiving an an- alyte fluid
  • At least one chemical reagent reservoir for storing at least one chemical reagent fluid
  • the channel comprising a measurement area
  • the measurement area comprises a sensor, and a memory device with cartridge data, a memory device reader for retrieving the cartridge data from the cartridge
  • an actuator unit for interacting with the cartridge such that the volume of the analyte reservoir and the volume of the at least one chemical reagent reservoir is reduced
  • an analyzer unit for interacting with the cartridge such that a physical value in the measurement area is measured using the sensor in accordance to the cartridge data
  • a communication unit for outputting the physical value.
  • the actuator unit is adapted for interacting with the cartridge such that the volume of the analyte reservoir and the volume of the at least one chemical reagent reservoir are reduced in accordance to the cartridge data.
  • the actuator unit comprises an analyte actuator for interacting with the . cartridge such that the volume of the analyte reservoir is reduced and a chemical reagent actuator for interacting with the cartridge such that the volume of the at least one chemical reagent reservoir is reduced.
  • a laboratory comprising a portable casing, the portable casing comprising
  • a tray unit for receiving a cartridge, the cartridge comprising an analyte reservoir for receiving an an- alyte fluid,
  • a first chemical reagent reservoir for storing a first chemical reagent fluid
  • a first mixture reservoir for receiving the analyte fluid with the first chemical reagent fluid via a first channel network
  • a second chemical reagent reservoir for storing a second chemical reagent fluid
  • the second channel network comprises a measurement area, the measurement area comprises a sensor
  • an actuator unit for interacting with the cartridge such that the volume of the analyte reservoir, the volume of the first chemical reagent reservoir with the second chemical reagent reservoir, and the volume of the first mixture reservoir are reduced
  • an analyzer unit for interacting with the cartridge such that a physical value in the measurement area is measured using the sensor
  • a communication unit for outputting the physical value .
  • the first channel network comprises a measurement area that comprises a sensor
  • the analyzer unit interacts with the cartridge such that a physical value in the measurement area is measured using the sensor.
  • the portable casing further comprising a memory device reader for retrieving cartridge data from the cartridge
  • the analyzer unit interacts with the cartridge such that the physical value in the measurement area is measured using the sensor in accordance to the cartridge data.
  • an analyte actuator for interacting with the cartridge such that the volume of the analyte reservoir is reduced
  • a chemical reagent actuator for interacting with the cartridge such that the volume of the first chemical reagent reservoir and the volume of the second chemical reagent reservoir are reduced
  • a mixture reservoir actuator for interacting with the cartridge such that the volume of the first mixture reservoir is reduced.
  • the actuator unit comprises at least one push area for manual actuation by a user of the laboratory.
  • the tray is provided as a movable tray.
  • the . communication unit comprises a Subscriber Identity Module (SIM) card interface.
  • SIM Subscriber Identity Module
  • a personal health hub comprising
  • a laboratory of one of the aforementioned items a computing device connecting to the laboratory fo retrieving at least one result of the laboratory, and a device accessible by the computing device for storing the at least one result of the laboratory.
  • a method of using a portable laboratory comprising
  • the analyte fluid is driven to fill at least one channel and the at least one chemical reagent fluid is driven to fill the at least one channel in accordance to the cartridge data.
  • a method of using a portable laboratory comprising
  • the analysis comprising driving the analyte fluid and a first chemical reagent fluid to fill a first mixture reservoir such that the analyte fluid mixes with the first chemical reagent fluid to form a first mixture, driving the first mixture and a second chemical reagent fluid to fill the second mixture reservoir, such that the first mixture mixes with the second chemical reagent fluid to form a second mixture, measuring at least one value of the second mixture,
  • the analysis further comprises measuring at least one value of the first mixture and wherein
  • the analysis is characterized in that the result of the analyte fluid is determined using the at least one measured value of the first mixture and the at least one measured value of the second mixture.
  • the method further comprises
  • a cartridge for a portable laboratory comprising
  • an analyte reservoir for receiving an analyte fl at least one chemical reagent reservoir for storing at least one chemical reagent fluid
  • the channel comprising a measurement area
  • the measurement area comprises a sensor for measuring a physical value in the measurement area and electrical contacts for accessing the sensor
  • an analyte contact area in the vicinity of the analyte reservoir, the analyte area being provided for contacting with an actuator unit for reducing the volume of the analyte reservoir
  • the at least one chemical reagent contact area in the vicinity of the at least one chemical reagent reservoir, the at least one chemical reagent contact area being provided for contacting with the actuator unit for reducing the volume of the at least one chemical reagent reservoir, and
  • the cartridge data further comprises data for actuating the analyte contact area and the least one chemical rea gent contact area.
  • a cartridge for a portable laboratory comprising
  • an analyte reservoir for receiving an analyte fluid
  • a first chemical reagent reservoir for storing a first chemical reagent fluid
  • a first mixture reservoir for receiving the analyte fluid with the first chemical reagent fluid via a first channel network
  • a second chemical reagent reservoir for storing a second chemical reagent fluid
  • the second channel network comprises a measurement area
  • the measurement area comprises a sensor for measuring a physical value in the measurement area and electrical contacts for accessing the sensor
  • an analyte reservoir contact area in the vicinity of the analyte reservoir the analyte reservoir contact area being provided for contacting with an analyte actuator for reducing the volume of the analyte reservoir
  • a first chemical reagent contact area in the vicinity of the first chemical reagent reservoir the first chemical reagent contact area being provided for contacting with a first chemical reagent actuator for reducing the volume of the first chemical reagent reservoir
  • a second chemical reagent contact area in the vicinity of the second chemical reagent reservoir, the second chemical reagent contact area being provided for contacting with a second chemical reagent actuator for reducing the volume of the second chemical reagent reservoir, and
  • first mixture reservoir contact area in the vicinity of the first mixture reservoir, the first mixture reservoir contact area being provided for contacting with a first mixture reservoir actuator for reducing the volume of the first mixture reservoir.
  • the cartridge according to item 27 further comprising a memory device with cartridge data.
  • cartridge data further comprises data for actuating the analyte contact area, the first chemical reagent contact area, the second chemical reagent contact area, and the first mixture reservoir contact area.
  • the measurement area comprises a measurement reservoir.
  • the cartridge according to one of items 24 to 31 further comprises a heater.
  • the cartridge according to one of items 24 to 32 further comprises a temperature sensor.
  • a cartridge unit for performing at least one test for a biological organ comprising
  • a cartridge according to one of items 24 to 33, the cartridge comprising at least one sensor, wherein the sensor measures at least one physical value of the biological organ.

Abstract

The application provides a laboratory. The laboratory comprises a portable casing. The portable casing comprises a tray unit and other parts. Referring to the tray unit, it is used for receiving a cartridge, wherein the cartridge comprises an analyte reservoir, at least one chemical reagent reservoir, at least one channel, and a memory device with cartridge data. The channel connects the chemical reagent reservoir with the analyte reservoir. The channel comprises a measurement area whilst the measurement area comprises a sensor. Referring to the other parts, it includes. an actuator unit, an analyzer unit, a memory device reader, and a communication unit. The memory device reader is used for retrieving the cartridge data from the memory device. The actuator unit is used for reducing the volume of the analyte reservoir and the chemical reagent reservoirs. The analyzer unit is used for measuring a physical value in the measurement area using the sensor in accordance with the cartridge data. The communication unit is used for outputting the physical value.

Description

ON-CHIP LABORATORY FOR BLOOD ANALYSIS
The present application relates to an on-chip laboratory for blood analysis. The present application also relates to a method of using the on-chip laboratory for blood analysis.
On-chip laboratories include devices for metering, measuring, and/or mixing liquid samples with chemical reagents, moving the mixtures into an integrated, temperature controlled reac- tion chamber, separating compositions, and/or determining results of the mixtures with an on-board biosensor. Cost associated with development and deployment of the known on-chip laboratories is prohibitive. The present application provides an on-chip laboratory that comprises an analysis cartridge having biosensors, a fluidic actuator coupled to the analysis cartridge for distributing analyte- fluids to biosensors, and an analyzer base connected to the analysis cartridge. The on-chip laboratory further comprises a universal interface for connecting the analysis cartridge to the analyzer base such that the analysis cartridge is interchangeable.
The universal interface comprises mechanical features that assemble the analysis cartridge and the analyzer base together. The universal interface further allows the analysis cartridge and the analyzer base to be taken apart so that a new analysis cartridge can be attached to the analyzer base. The analysis cartridge thus becomes detachable to the analyzer base. The universal interface also provides electrical connections between the analysis cartridge and the analyzer base such that the analysis cartridge and the analyzer base can be electrically coupled for performing tests. When required, a used analysis cartridge can be removed from the analyzer base so that on-chip laboratory is replaced with a new analysis cartridge for fresh analyses. The new analysis cartridge shares the same electrical terminals on the analyzer base even if the new analysis cartridge has biosensors that are different from the original analysis cartridge. In fact, the universal interface can comprises a common data exchange format or/and common communication protocols so that computing software for acquiring and analyzing becomes more general for the wide variety of sensors and analysis types.
For example, the universal interface comprises a socket on the analyzer base and a plug on the analysis cartridge. The universal interface also comprises electrical terminals on the socket and on the plug with predetermined dimensions, locations and electrical ratings. Alternatively, the universal interface can be provided by any part of the on-chip laboratory so that other parts of the on-chip laboratory can be reused for cost-effective analyses.
The on-chip laboratory having the universal interface is provided for a wide variety of biosensors because many analysis cartridges with diversified biosensors can share the same universal interface for connecting to the analyze base. The on-chip laboratory can provide a common mechanical, electronic and computing platform for many different analyses and different biosensors. Cost of development and deployment of mechanical, electronic and computing platforms for catering different biosensors is much reduced. The universal interface also provides users with ease of daily operation, instead of keeping upgrading or learning new applications associated with biosensors of new types, from different manufacturers or having improved accuracies. Inventories and logistic effort 1
3
of both manufacturers and the users can be reduced. Consequently, pharmaceutical groups can be more focus on their expertise in developing and industrializing sensing chemistry and biosensor design.
The biosensors can comprise different types. The biosensors include photometric type of biosensors that are optical biosensors based on the phenomenon of surface plasmon resonance using evanescent wave techniques. The biosensors also include electrochemical biosensors that are based on enzymatic catalysis of a reaction for producing or consuming electrons. The enzymes are redox enzymes. The biosensors further include piezoelectric sensors that utilize crystals undergoing an elastic deformation when an electrical potential is applied to them.
Each one of the different types of biosensors can be used for different purposes of analyses, possibly for the same analyte fluid. For example, the electrochemical type of biosensor can be used for glucose monitoring in diabetes patients; routine analytical measurement of folic acid, biotin, vitamin B12 and pantothenic acid; and detection of pathogens.
The same type of biosensors can include different kinds of biosensors. For example, the electrochemical type of biosensor can include ECG biosensor or glucose biosensor.
Even the same biosensor can be used for analyses of different purposes .
In short, the analysis cartridge can have biosensors of different types for different purposes of analyses. The analysis cartridge provides a common stage that many types, kinds and numbers of biosensor can be integrated for analyzing the analyte fluid at the same time. Savings from time and material can greatly benefit manufacturers, users such as hospitals and doctors, and patients in bring better medical care.
The analysis cartridge can comprise a sample reservoir and chemical reagent reservoirs for containing the analyte fluids. The sample reservoir can be in the form of multiple reservoirs that are connected by fluidic channels or disconnect- ed. Similarly, the chemical reagent reservoirs can be connected or disconnected to each other, or in the form of a single reservoir. The analysis cartridge with the sample reservoir and the chemical reagent reservoirs does not require additional containers for carrying the analyte fluids and can further be discarded once used. Errors and contaminations during analysis can be avoided.
The fluid actuator may comprise a sample actuator and a chemical reagent actuator. Separating the fluid actuator into two parts enables the function of having two-stage fluid release. In some situations, the chemical reagent actuator can be firstly triggered for discharging chemical reagents for biosensor calibration. Subsequently, the sample actuator can be set off for expelling sample fluid. The expelled sample fluid is later mixed with the chemical reagent for analyzing. Measurement accuracy of the on-chip laboratory is improved.
The analysis cartridge can further comprise waste reservoirs that are connected to the sample reservoir and the chemical reagent reservoirs via fluidic paths. The waste reservoirs are empty before the activation of the fluid actuator. In particular, the biosensors can be provided at the waste reservoirs. The on-chip laboratory does not have to provide bio- sensors at every reservoir so that the complexity and cost of the analysis cartridge is reduced. Separating the biosensors from the sample reservoir and the chemical reagent reservoirs also provide flexibility in designing analysis scheme or flu- idic paths.
The analysis cartridge further can comprise a heater for warming up the . analyte fluids. Some analyses of the body fluids are temperature dependent, including blood samples. The heater provides a tool for maintaining analyte fluids temperatures for accurate data acquisition.
The analysis cartridge can further comprise temperature sensors for monitoring temperatures of the analyte fluids . The temperature sensors can provide temperature readings for compensating or correcting analyses results. The temperature sensors can further be used for controlling the heater during analyses . The analyzer base comprises a Subscriber Identity Module
(SIM) card interface. The SIM card module enables the on-chip laboratory to check identity information so that only authorized user can access and operate the on-chip laboratory. A manufacturer of the on-chip laboratory can preclude others from using the on-chip laboratory to ensure his financial return based on the device. The SIM card can also prevent unauthorized persons accessing sensitive proprietary data or medical records. The SIM card may further memory for storing data on other personal details, operation manuals, , parameter settings, or doctors information.
The application can provide a personal health hub that comprises the on-chip laboratory, a personal computer for con- necting to the on-chip laboratory, and a Personal health card readable by the personal computer for editing analyses results on the Personal health card. The Personal health card is data storage memory card that is readable by computing de- vices. For example, the Personal health card can be a smart card that is accessible by a multi-card reader of a personal computer (PC) . A patient or his family doctor can keep the Personal health card for storing personal medical records. The Personal health card can be updated with new analyses re- suits from the on-chip laboratory. The stored results can further edited, retrieved or shared by other medical professionals for helping a patient with the Personal health card.
According to the application, there is provided a method of assembling an on-chip laboratory comprising the steps of providing an analyzer . base, inserting an analysis cartridge onto the analyzer base, dosing analyte fluids onto the analysis cartridge, mounting a fluidic actuator, and replacing the analysis cartridge with a new analysis cartridge for resuming a fresh analysis. A used analysis cartridge is replaced with a new analysis cartridge so that new analyses can be carried out. In other words, the analyzer base is preserved for connecting both the used and the new analysis cartridge. Equipment that connects the analyzer base for data acquisition and displaying are not changed when using both the analysis cartridges. Further changes of software are also avoided. Consequently, cost of using the on-chip laboratory is much reduced, which includes training of the users, software development, hardware design and manufacturing, etc. The analyzer base becomes universal for analysis cartridges, regardless the number or types of biosensors installed on the analysis cartridge . The can further comprise covering the analyte fluids with a membrane. The membrane seals analyte fluids in the analysis cartridge so that an analyte fluids carrying analysis cartridge can be transported or stored without the risk of con- tamination. The membrane can further be transparent so that visual observation and optical analysis can be performed with the least disturbance to the cartridge. The membrane can be made of low cost plastic materials, such as low-density polyethylene (LDPE) for reducing overall cost of using the on- chip laboratory.
In the application, there is provided a method of using an on-chip laboratory comprising the steps of assembling an on- chip laboratory with an analysis cartridge, initializing the on-chip laboratory, activating the on-chip laboratory, acquiring data of the on-chip laboratory, and replacing the analysis cartridge with a new analysis cartridge for fresh analyses. The initializing step can be starting up a software program on a PC and a firmware on the on-chip laboratory, while the PC is connected to the on-chip laboratory. The activating step can be releasing any one of the analyte fluids for biosensor calibration and other analyses. For example, the activating step comprises inserting plungers into reservoirs of the analyte fluids in order to displace them and forcing them into desired analyzing site known as waste reservoirs. Alternatively, the activating can be performed by turning on and off certain valves for distributing the analyte fluids. The step of acquiring data can involve using electronic hardware, firmware and software. The data of spe- cific interest are generated by biosensors in relation to the analyte fluids. The step of replacing the analysis cartridge avoids changing the whole on-chip laboratory totally. In fact, the number of parts for the replacing can be minimized and only restricted to the parts in physical contact with the analyte fluids. Remaining parts of the on-chip laboratory are preserved so that a fresh analysis cartridge can just be inserted and resume a new of analysis. In this case, substan- tial amount of saving can be realized by reusing the remaining parts. New software program of an on-chip laboratory connected PC, new firmware and new electronic hardware are avoided. The acquiring data of the on-chip laboratory can comprise acquiring data for analyses of different purposes. For the same analyte fluids, there are many purposes of analyses that can be carried out simultaneously, whether using the same type or kind of biosensors. For example, the same blood sample can be examined for sodium, potassium, blood urea nitrogen, urea, creatinine, glucose, and glycosylated hemoglobin. This method can greatly improve efficiency of the data acquisition. When multiple biosensors of the same type or kind are installed in the same on-chip: laboratory, acquired data can be scrutinized for counter-check their values to ensure accuracy and reliability.
The present application. also provides a method of using a personal health hub that comprises the steps of connecting the personal health hub and replacing the analysis cartridge with a new analysis cartridge. The personal health hub can be portable and connected to any other PC with suitable software. As a result, the personal health hub can either be used in a doctor's office or a patient's home with convenience. The step of replacing the analysis cartridge is specially advantages because there can be no need in having new software, new firmware, new hardware electronics and new training for users just because of having a new analysis cartridge with new biosensors. Substantial amount of saving in manpower and material cost can be achieved. In other words, the personal health hub or the on-chip laboratory has the flexibility of accepting new biosensors on the analysis cartridge with the same universal interface.
The application provides a medical laboratory. The laboratory comprises a portable casing. The portable casing comprises a tray unit, an actuator unit, an analyzer unit, and a communication unit.
The tray unit is used for receiving a cartridge. The cartridge comprises an analyte reservoir for receiving an analyte fluid, one or more chemical reagent reservoirs for storing one or more chemical reagent fluids, and one or more channels connecting the chemical reagent reservoirs with the analyte reservoir. The analyte fluid can include blood, urine, salvia, and feces. The channel comprises a measurement area whilst the measurement area comprises a sensor.
The actuator unit is used for reducing the volume of the analyte reservoir to drive the analyte fluid to fill the channels. In addition, the actuator unit is also used for reducing the volume of the chemical reagent reservoirs to drive the chemical reagent fluids to fill the channels such that the analyte fluid mixes with the chemical reagent fluids to form one or more mixtures .
The analyzer unit is used for measuring a physical value in the measurement area using the sensor to measure the mixture The analyzer unit can have a processor to determine a result of the analyte fluid using the measured values. The communication unit is used for outputting the physical value. The portable casing has an advantage of allowing analysis of the analyte fluid to be done outdoor. This is especially important in remote areas. Furthermore, the actuator unit ena- bles the mixtures to be formed within the portable casing without requiring much user skill.
The measurement area can comprise a mixture reservoir. This allows the mixtures of the chemical reagent fluids and the analyte fluid to collect or gather for easier measurement.
The actuator unit can comprise an analyte actuator and a chemical reagent actuator. This allows separate volume of the respective fluids, which is needed in certain situations. In addition, the actuator unit can comprise a push area, such as a push button> for manual actuation by a user of the laboratory. The manual can allow the laboratory to be simple and of low cost. The tray can be provided as a movable, such as a slidable tray. The moveable tray enables a easy receiving of the cartridge.
The cartridge further comprises one or more waste analyte reservoirs and one or more chemical waste reservoir. The waste analyte reservoirs and the chemical reagent waste reservoirs are connected to the analyte reservoir and to the chemical reagent reservoirs via the fluid channels. Functionally, the waste analyte reservoirs can receive the excess an- alyte fluid whilst the chemical waste reservoir can receive the excess chemical reagent. The cartridge can include a heater for heating the analyte fluid and it can include a temperature sensor for monitoring a temperature of the analyte fluid. For certain analysis, the analyte fluid needs to be heated.
The communication unit can include a Subscriber Identity Module (SIM) card interface. This allows the result to be out- putted via a wireless means. The application provides a personal health hub. The personal health hub includes the above laboratory, a computing device connecting to the laboratory, and a device accessible by the computing device for storing one or more results of the laboratory.
The application provides a method of using a portable laboratory. The method comprises a step of a cartridge receiving a analyte fluid. The cartridge is then placed inside a portable casing for analyzing the analyte fluid.
The analysis includes a step of an actuator unit of the casing driving the analyte fluid to fill a part of one or more fluid channels and driving one or more chemical reagent fluids to fill a part of one or more fluid channels. The filling is done such that the analyte fluid mixes with the chemical reagent fluids to form one or more mixtures. One or more sensors of the casing later measure one or more values of the mixtures. A processor of the casing afterward determines a result of the analyte fluid using the measured values. A com- munication unit of the casing then outputs the result.
The method can include a step of heating any one of the analyte fluid and the chemical reagent fluids. The analysis can include a step of measuring temperature of the analyte fluid. Theses step are required for certain analysis of the analyte fluid. The result also can be outputted to one or more LED lights or to an external computing device for communicating the result to a user.
The application provides a cartridge for a portable laborato- ry. The cartridge comprises an analyte reservoir, one or more chemical reagent reservoirs, one or more fluid channels, a first contact area, and a second contact area.
The analyte reservoir is used for receiving an analyte fluid. The chemical reagent reservoirs are used for storing the chemical reagent fluids. The. channels are used for connecting the chemical reagent reservoirs with the analyte reservoir. The channels comprise measurement areas. In particular, the measurement areas comprise sensors for measuring physical values in the measurement areas and electrical contacts for accessing the sensors.
The first contact area is placed in the vicinity of the analyte reservoir. The first contact area is provided for con- tacting with an actuator unit for reducing the volume of the analyte reservoir to drive the analyte fluid to fill the channels. Similarly, the second contact area is placed in the vicinity of the chemical reagent reservoir. The second contact area is provided for contacting with the actuator unit for reducing the volume of the chemical reagent reservoirs to drive the chemical reagent fluids to fill the channels such that the analyte fluid mixes with the chemical reagent fluids to form one or more mixtures . The measurement area often includes a mixture reservoir. The mixture reservoir allows a gathering of the fluid mixture for easier measurement.
The cartridge can comprise one or more waste analyte reservoirs and one or more chemical waste reservoirs. The waste analyte reservoirs and the chemical reagent waste reservoirs are connected to the analyte reservoir and to the chemical reagent reservoirs via the fluid channels. The waste analyte reservoirs and the chemical reagent waste reservoirs can be used to store excess fluids.
The cartridge can comprise a heater in the vicinity of the analyte reservoir for heating the analyte fluid. This is required for certain analysis.
Moreover, the cartridge can comprise a temperature sensor in the vicinity of the analyte reservoir for monitoring a temperature of the analyte fluid. This is also required for certain analysis.
The combination of heater and temperature sensors can provide a temperature control, which may be used for controlling reaction between the analyte fluid and a chemical reagent. The reaction often follows the Arrhenius law or equation and is directly dependent of temperature.
For a chemical reaction where substance A and B are reacting to produce C, the reaction rate has the form:
Reaction: A + B → C d[C]
> = k(T)[AT[B]"
dt wherein k(T) is the reaction rate constant that depends on tempera- ture,
[C] is the concentration of substance C in moles per volume of solution assuming the reaction is taking place throughout the volume of the solution (for a reaction taking place at a boundary it would denote something like moles of C per area). The exponents "m" and "n" are called orders and they depend on the reaction mechanism and can be determined experimental- ly.
Thus, the module of heater and temperature sensors inserted in a sensor cartridge boosts a collection of electrical cur- rent on the electrodes for better response time and precision. This can be achieved for example by increasing the temperature from about 37 to about 50 Celsius. This property also allows use of smaller blood sample size for analysis.
The application provides a laboratory with cartridge date. The laboratory comprises a portable casing, a memory device reader, an actuator unit, an analyzer unit, and a communication unit.
Referring to the portable casing, it includes a tray unit for receiving a cartridge in which the cartridge comprises a plurality of reservoirs and a memory device. The plurality of reservoirs includes an analyte reservoir, at least one chemical reagent reservoir, and at least one channel. In particu- lar, the analyte reservoir is intended for receiving an analyte fluid, such as a blood sample. The chemical reagent reservoir is intended for storing a chemical reagent fluid for mixing with the analyte fluid. The channel connects the chem- ical reagent reservoir with the analyte reservoir to provide a fluidic passage between the chemical reagent reservoir and the analyte reservoir. The channel also comprises a measurement area, wherein the measurement area comprises a sensor. The memory device includes cartridge data that includes sen- sor data.
Referring to the memory device reader, it is intended for retrieving the cartridge data from the memory device of the cartridge. The actuator unit is intended for interacting with the cartridge such that the volume of the analyte reservoir and the volume of the at . least one chemical reagent reservoir is reduced. The analyzer unit is intended for interacting with the cartridge such that a physical value in the measurement area is measured using the sensor in accordance to the cartridge data. The communication unit is intended for out- putting the physical value.
The cartridge data allows a user to operate the cartridge in a manner that is intended by its manufacturers.
For security purpose, the cartridge data can be encrypted such that only devices with the appropriate decryption key can use the cartridge. The actuator unit can be adapted for interacting with the cartridge such that the volume of the analyte reservoir and the volume of the at least one chemical reagent reservoir are reduced in accordance to the cartridge data. The actuator unit can comprise an analyte actuator for interacting with the cartridge such that the volume of the analyte reservoir is reduced. Similarly, the actuator unit can also comprise a chemical reagent actuator for interacting with the cartridge such that the volume of the at least one chemical reagent reservoir is reduced.
The application provides a laboratory that comprises a porta- ble casing. The portable casing includes a tray unit, an actuator unit, an analyzer unit, and a communication unit.
Referring to the tray unit, it is used for receiving a cartridge, wherein the cartridge comprises a plurality of reser- voirs. The plurality of reservoirs includes an analyte reservoir, a first chemical reagent reservoir together with a second chemical reagent reservoir, a first mixture reservoir, a second chemical reagent reservoir, and a second mixture reservoir.
The analyte reservoir is used for receiving an analyte fluid. The first and the second chemical reagent reservoirs are used for storing a first chemical reagent fluid and a second chemical reagent fluid respectively. The first mixture reservoir is used for receiving the analyte fluid from the analyte reservoir with the first chemical reagent fluid from the first chemical reagent reservoir via a first channel network. The second mixture reservoir is used for receiving the analyte fluid with the first chemical reagent fluid from the first mixture reservoir and the second chemical reagent fluid from the second chemical reagent reservoir via a second channel network. Moreover, the second channel network comprises a measurement area in which the measurement area comprises a sensor.
Referring to the actuator unit, it is used for interacting with the cartridge such that the volume of the analyte reservoir, the volume of the first chemical reagent reservoir with the second chemical reagent reservoir, and the volume of the first mixture reservoir are reduced. The analyzer unit is used for interacting with the cartridge such that a physical value in the measurement area is measured using the sensor. The communication unit is used for outputting the physical value.
The first channel network can comprise a measurement area that includes a sensor in which the analyzer unit interacts with the cartridge such that a physical value in the measurement area is measured using the sensor.
In addition, the portable casing can have a memory device reader for retrieving cartridge data from a memory device of the cartridge. The analyzer unit then interacts with the cartridge such that the physical value in the measurement area is measured using the sensor in accordance to the cartridge data.
The actuator unit can be adapted for interacting with the cartridge such that the volume of the analyte reservoir, the volume of the first chemical reagent reservoir and the volume of the second chemical reagent reservoir, and the volume of the first mixture reservoir are reduced in accordance to the cartridge data. In one implementation, the actuator unit comprises an analyte actuator, a chemical reagent actuator, and a mixture reservoir actuator. Specifically, the analyte actuator is used for interacting with the cartridge such that the volume of the analyte reservoir is reduced. The chemical reagent actuator is used for interacting with the cartridge such that the volume of the first chemical reagent reservoir and the volume of the second chemical reagent reservoir are reduced. The mixture reservoir actuator is used for interacting with the cartridge such that the volume of the first mixture reservoir is reduced.
The actuator unit can comprise one or more push areas for manual actuation by a user of the laboratory. The tray can be provided as a movable tray. The communication unit can comprise a Subscriber Identity Module (SIM) card interface for easy implementation.
The application provides a personal health hub. The personal health hub comprises the abovementioned laboratory, a computing device, and a device. The computing device connects to the laboratory for retrieving one or more results of the laboratory. The device is . accessible by the computing device for storing the results of the laboratory.
The application provides a method of using a portable laboratory with cartridge data.
The method includes a step of storing cartridge data in a memory device of a cartridge. Put differently, the cartridge data is stored in the cartridge. The cartridge is then provided with an analyte fluid. The analyte fluid can be obtained from a patient or a living being. After this, the car- tridge is placed in a portable casing of the portable laboratory for analyzing the analyte fluid.
The analysis includes a step of retrieving the cartridge data from the memory device of the cartridge by a memory device reader of the portable casing. This allows the laboratory to use the cartridge data to operate the cartridge. The analyte fluid is later driven using an actuator to fill one or more channels. One or more chemical reagent fluids are also driven to fill the channel. The driving is done such that the analyte fluid mixes with the chemical reagent fluid to form a mixture. One or more values of the mixture are afterward measured in a way that is in accordance to the cartridge data. Following this, a result of the analyte fluid is deter-. mined using the measured values. The result is then output- ted.
In general, the analyte fluid can be driven to fill the channel and the chemical reagent fluid is driven to fill the channel in a manner that is in accordance to the cartridge data .
The application provides a method of using a portable laboratory. The method allows a test sample to be subjected to a series of test.
The method includes a step of providing the cartridge with an analyte fluid, such a blood sample. The blood sample is taken for living being, such as a patient. The cartridge is later placed in a casing of the portable laboratory for analyzing the analyte fluid. The analysis comprises several steps of actuating fluids of the cartridge. These steps include driving the analyte fluid and a first chemical reagent fluid from a first chemical reagent reservoir to fill a first mixture reservoir such that the analyte fluid mixes with the first chemical reagent fluid to form a first mixture. The first mixture and a second chemical reagent fluid are then driven to fill a second mixture reservoir such that the first mixture mixes with the second chemical reagent fluid to form a second mixture. The second chemical reagent fluid is driven from a second chemical reagent reser- voir.
Later, one or more values of the second mixture are measured using a sensor. A result of the analyte fluid is afterward determined using the measured values. As an example, the sen- sor can provide electrical current readings of a mixture. The readings are then converted to corresponding glucose values to provide, a test result of the mixture. The determination of the result is done, in this case, by the conversion of the electrical current readings.
The result is then outputted to a display unit, such as LED lights for displaying an "acceptable" or "unacceptable" result, or to an external . computing device for further processing .
The step of analysis can comprise a step of measuring one or more values of the first mixture. These values can serve to as immediate verification readings. The result of the analyte fluid can be determined using the measured value of the first mixture together with the measured value of the second mixture . To use a cartridge data, the method can further comprise a step of storing cartridge data in a memory device of a cartridge. The cartridge data is later retrieved from the memory device of the cartridge by a memory device reader of the portable casing. One or more values of the first or of the second mixture are then measured in accordance to the cartridge data.
The analyte fluid together with the first chemical reagent fluid can be driven to fill a first mixture reservoir in a manner that is in accordance to the cartridge data. The first mixture together with the second chemical reagent fluid can also be driven to fill the second mixture reservoir in a manner that is in accordance to the cartridge data. The analyte fluid, the first chemical reagent fluid, and the second chemical reagent fluid may be to driven at different time with different durations for different tests. For ease of use, the; relevant data can incorporated in the cartridge data. The result of the analyte fluid can then be determined using the measured value in accordance to the cartridge data.
For better control of the analysis, the analysis can include a step of heating the analyte fluid and/or the chemical rea- gent fluid as needed. Temperature of the analyte fluid and/or the chemical reagent fluid can also be measured for temperature control purpose.
The result can be outputted in a variety of ways. It be out- putted to at least one LED light or to an external computing device . The application provides a cartridge for a portable laboratory. The cartridge itself provides data for using the cartridge. The cartridge includes several reservoirs or wells with corresponding contact areas and a memory device.
Referring to the reservoirs, they include an analyte reservoir, at least one chemical reagent reservoir, and at least one channel. The analyte reservoir is used for receiving an analyte fluid. The chemical reagent reservoir is used for storing a chemical reagent fluid. The channel connects the chemical reagent reservoir with the analyte reservoir, wherein the channel comprises a measurement area. The measurement area comprises a sensor for measuring a physical value in the measurement area and electrical contacts for accessing the sensor.
Referring to the contact areas, they include an analyte contact area and at least one chemical reagent contact area. The analyte contact area is positioned in the vicinity of the an- alyte reservoir and it provided for contacting with an actuator unit for reducing the volume of the analyte reservoir. The chemical reagent contact area is positioned in the vicinity of the at least one. chemical reagent reservoir and it is provided for contacting with the actuator unit for reducing the volume of the chemical reagent reservoir.
Referring to the memory device, it has cartridge data, which is used for operating the sensor. Equipped with the sensor data, the cartridge can be used easily. Using the cartridge with the incorrect cartridge data by mistake is also avoided. The cartridge data can also comprise data for actuating the analyte contact area and data for actuating the least one chemical reagent contact area. These areas might be actuated differently for different analyte fluids and for different tests. Again equipping the cartridge with the said information is not only useful but also convenient for the user. For security reasons, the cartridge data can be encrypted. Thus, only devices with the necessary decrypted key may use the cartridge.
The application provides a cartridge for a portable laboratory. The cartridge is used for processing a series of tests. The tests can relate a biological organ of a living being. The cartridge includes a plurality of parts for holding a plurality of fluids and a plurality corresponding areas for actuating fluids.
Referring to the plurality of parts, it includes an analyte reservoir, a first chemical reagent reservoir and a second chemical reagent reservoir, as well as a first mixture reser voir and a second mixture reservoir.
The analyte reservoir is used for receiving an analyte fluid. The first chemical reagent reservoir is used for storing a first chemical reagent fluid while the second chemical reagent reservoir is used for storing a second chemical reagent fluid.
The first mixture reservoir is used for receiving the analyte fluid from the analyte reservoir via a first channel network. The channel network includes one or more fluid passageways. It is also used for receiving the first chemical reagent fluid from the first chemical reagent reservoir via the first channel network. The analyte fluid and the first chemical reagent reservoir are received such that that they mix to form a first mixture. Similarly, the second mixture reservoir is used for receiving the first mixture of the analyte fluid with the first chemical reagent fluid from the first mixture reservoir via a second channel network. The second mixture reservoir is also used for receiving the second chemical reagent fluid from the second chemical reagent reservoir via the same second channel network. The first mixture and the chemical reagent fluid are received such that they mix to form a second mixture.
The second channel network includes a measurement area that comprises a sensor. The sensor is used for measuring a physical value of the second mixture in the measurement area. The second channel network also includes electrical contacts for accessing the said sensor. Referring to the plurality fluid actuating areas, it includes an analyte reservoir contact area, a first chemical reagent contact area, a second chemical reagent contact area, a first mixture reservoir contact area, The analyte reservoir contact area is located in the vicinity of the analyte reservoir. It is provided for contacting with an analyte actuator for reducing the volume of the analyte reservoir . Similarly, the first and the second chemical reagent contact areas are located in the vicinity of the first and the second chemical reagent reservoirs respectively. They are provided for contacting with a first chemical reagent actuator and a second chemical reagent actuator respectively for reducing the corresponding volumes of the first and the second chemical reagent reservoirs. The first mixture reservoir contact area is located in the vicinity of the first mixture reservoir. It is provided for contacting with a first mixture reservoir actuator for reducing the volume of the first mixture reservoir. The cartridge is able to support a testing of the analyte fluid with more than one chemical reagent. This is different from other implementations.
The cartridge can include a memory device with cartridge data for using the sensor. Put differently, the data for using the cartridge can be placed in the cartridge that the usage and the cartridge are together. A user does not have to spend time searching for cartridge data before using the cartridge. The cartridge data can also comprise data for actuating fluids within the cartridge. In particular, the data includes information for the analyte contact area, the first chemical reagent contact area, the second chemical reagent contact area, and the first mixture reservoir contact area. These areas might need to be actuated in a particular sequence with a certain time period between each actuation. The information can be incorporated in the cartridge data for complete teaching on the use of the cartridge. A laboratory using the cartridge simply needs to read the information when the labora- tory is using the cartridge.
For handling fluid spill when a containing well is full, the cartridge mentioned above can include a waste analyte reser- voir and one or more chemical waste reservoirs. The waste an- alyte reservoir is connected to the analyte reservoir an ana- lyte channel while the chemical reagent waste reservoir is connected to the chemical reservoir via a chemical reagent waste channel.
The measurement area can include a measurement reservoir or well to collect a testing sample for easy testing or measurement .
As most chemical reactions are dependent on temperature, the cartridge mentioned above can have a heater. The heater may be located, for example, in the vicinity of the analyte reservoir. The cartridge often comprises a temperature sensor to control the heater.
The application provides a cartridge unit for performing at least one test for a biological organ, such as a liver of human being. The cartridge unit includes the cartridge men- tioned above. The cartridge comprises one or more sensors. The sensor measures one or more physical values of the biological organ. In other words, the cartridge unit is used for obtaining results for one or more tests of a biological organ.
Figure 1 illustrates a schematic of an embodiment of a portable laboratory unit,
Figure 2 illustrates a flow chart for the portable laboratory unit of Figure 1,
Figure 3 illustrates a further flow chart for the portable laboratory unit of Figure 1,
Figure 4 illustrates an analysis of a kidney using the portable laboratory unit of Figure 1, Figure 5 illustrates an analysis of a patient with a cardiac post-operation condition using the portable laboratory unit of Figure 1,
Figure 6 illustrates a table of values of measurements of the analysis of Figures 4 and 5,
Figure 7 illustrates a pin connection table for the portable laboratory unit of Figure 1,
Figure 8 illustrates an exploded schematic view of another embodiment of the portable laboratory,
Figure 9 illustrates a schematic view of an embodiment of a multi-analysis cartridge for the portable laboratory of Figure 8,
Figure 10 illustrates a schematic view of another embodiment of the multi-analysis cartridge for the portable laboratory of Figure 8, and
Figure 11 illustrates an embodiment of a casing for the portable laboratory of Figure 8.
In the following description, details are provided to de- scribe the embodiments of the application. It shall be apparent to one skilled in the art, however, that the embodiments may be practiced without such details.
Figures described below have similar parts. The similar parts have the same names or similar part numbers. The description of the similar parts is hereby incorporated by reference, where appropriate, thereby reducing repetition of text without limiting the disclosure. For sake of shortness, the embodiments of WO 2010/125518 A9 with its alternatives and implementations are included here as a reference. The embodiments are shown at: - page 17, line 7 to page 28, line 8 together with Figs. 1 to 6 of WO 2010/125518 A9 with its alternatives and implementations relating to an on-chip laboratory for blood analysis,
- page 28, line 10 to page 30, line 20 together with Fig. 7 of WO 2010/125518 A9 with its alternatives and implementations relating to electronic components for a multi-analysis cartridge,
- page 30, line 22 to page 31, line 30 together with Figs. 8 and 9 of WO 2010/125518 A9 with its alternatives and imple- mentations relating to a blood sample temperature sensor for a multi-analysis cartridge,
- page 31, line 1 to page 33, line 12 together with Figs. 10 to 12 of WO 2010/125518 A9 with its alternatives and implementations relating to a biosensor for a multi-analysis car- tridge,
- page 33, line 14 to page 34, line 26 together with Figs. 13 to 15 of WO 2010/125518 A9 with its alternatives and implementations relating to a resistance thermometer for a multi- analysis cartridge,
- page 34, line 28 to page 39, line 9 together with Figs. 16 and 17 of WO 2010/125518 A9 with its alternatives and implementations relating to electronic components of an on-chip laboratory,
- page 39, line 11 to page 43, line 20 together with Fig. 18 of WO 2010/125518 A9 with its alternatives and implementations relating to a personal health hub using an on-chip laboratory,
- page 43, line 22 to page 44, line 32 together with Fig. 19 of WO 2010/125518 A9 with its alternatives and implementa- tions relating to an assembling method of an on-chip laboratory,
- page 45, line 1 to page 45, line 24 together with Fig. 20 of WO 2010/125518 A9 with its alternatives and implementa- tions relating to releasing chemical reagents from chemical reagent reservoirs for biosensor calibration for a multi- analysis cartridge,
- page 45, line 26 to page 46, line 12 together with Fig. 21 of WO 2010/125518 A9 with its alternatives and implementations relating to a method of blood analysis using an on-chip laboratory,
- page 46, line 14 to page 48, line 28 together with Figs. 22 to 26 of WO 2010/125518 A9 with its alternatives and imple- mentations relating to a electrodes of a biosensor,
- page 48, line 30 to page 52, line 31 together with Figs. 27 to 33 of WO 2010/125518 A9 with its alternatives and implementations relating to a glucose biosensor for a multi- analysis cartridge, and
- page 53, line 1 to page 56, line 29 together with Figs. 34 to 41 of WO 2010/125518 A9 with its alternatives and implementations relating to a further portable laboratory unit.
Figure 1 shows a schematic of a portable laboratory unit 450 for receiving an improved cartridge module 454. The cartridge module 454 is also called a sensor cartridge. The senor cartridge is improved to reduce cost and to improve ease of implementation. The portable laboratory unit 450 includes a smart card reader 456. The cartridge module 454 includes at least one monitoring sensor, which is provided as a bio-chemical sensor. Several monitoring sensors can be provided in a sensor array. The cartridge module 454 also includes a smart card 458 that is inserted in a casing of the cartridge module 454. The smart card 458 includes a micro-controller structure that embeds a memory device 459. The memory device 459 comprises a non-volatile semiconductor memory. The micro-controller structure is not shown in Figure 1.
Functionally, the cartridge module 454 is used for receiving a biological fluid, such as whole blood or serum, from a patient.
The monitoring sensor relies on amperometric, potentiometric, inpedencometric, or calorimetric techniques to provide meas- urements. The amperometric technique relates to a chemical titration in which the measurement of an electric current flowing under an applied potential difference between two electrodes in a solution is used. The biochemical sensor refers to a chemical sensor that is used in medical diagnosis and in patient monitoring. The biochemical sensor has electrochemical or optical features. It is characterized by a response curve and is operated using a measurement protocol. In one example, the response curve shows an electrical current versus concentration of species of interest relationship. The measurement protocol comprises test conditions with wait times to initiate a chemical reaction for obtaining a sensor reading. The non-volatile memory of the memory device 459 is used to store sensor characteristic data, sensor traceability data, as well as specific sensor measurement protocol data in a form of a software file during production of the cartridge module 454. These stored data are used to configure and to operate the monitoring sensor of the cartridge module 454. The software file is provided in an XML (Extensible Mark-up Language) format for ease of meeting current and forecasted regulations on medical electronic data. The microcontroller structure is used for securing and protecting the stored data of the memory device 459 with an encryption scheme such that the stored data is prevented from being copied for unauthorized use by counterfeit sensors or by sensors produced by unauthorized manufacturers.
The portable laboratory unit 450 is used for receiving the cartridge module 454 and for analyzing the biological fluid within the cartridge module 454.
The smart card reader 456 is used for reading or obtaining data stored in the memory device 459 such that the laboratory unit 450 can operate the monitoring sensors of the cartridge module 454 to obtain sensor measurements.
A method of using the portable laboratory unit 450 with an external computer is shown by a flow chart 465 of Figure 2. The flows chart 465 shows steps of analysis for a patient with an instable coronary condition.
The flow chart 465 includes a step 470 of indicating for bio- analysis for a patient with coronary artery disease symptoms by a doctor. After this, the doctor selects an appropriate sensor cartridge 454 with a sensor array in a step 473. The sensor array is used in this case is used for measuring Troponin, CK-MB Myoglobin, BNP/ NT-proBNP, and Prothrombin Time/INR. The sensor cartridge 454 with its smart card 458 is later placed in the smart card reader 465 of the portable laboratory unit 450 in a step 476. This placing also initiates the reading of the smart card 458 by the smart card reader 465, wherein the smart card reader 465 reads instructions from the memory device 459 of the smart card 458. As directed by the read instructions, the smart card reader 465 afterward extracts information from the memory device 459 in a secured manner. The information is then downloaded into a database of a software operating system of the portable blood laboratory unit 450 to activate a sequence of checks and actions.
The extract information is later used by the smart card read- er 465 to check reference data for the sensor of the sensor cartridge 454 against another internal database of accepted sensor sources. The reference data include brand data, distributor data, species or set of species measurement parameter data, measurement method data, lot number data, and expi- ration date data. When the smart card reader 465 detects any data anomaly, the use of the sensor cartridge 454 is stopped.
After this, the smart card reader 465 downloads measurement protocol data for the sensor of the sensor cartridge 454 from the smart card memory in a form of instructions sets.
A biological fluid, which is provided in a form of blood, is then drawn from a living individual for injecting into the sensor cartridge 454 in a step 479. A device lid of the port- able laboratory unit 450 is later closed to initiate actuation of the biological fluid within the sensor cartridge 454 in a step 482.
Later, the sensors are activated according to the instruction set downloaded by the smart card reader 465 in a step 485. The instruction set provides a sequence of several measurement phases with steps to activate the sensors as well as da- tasets with relevant limits for checking elementary functionality of the sensors.
The sensor readings are then taken according to the above in- struction set in a step 488. The instruction set also has a sequence of several measurement phases with voltage data, frequency data, and electrical current data for applying to the sensors for obtaining sensor measurements. The instruction set may have instructions to repeat the measurement phases for obtaining multiple sensor measurements. The multiple sensor measurements are done especially in a situation where the sensor cartridge 454 comprises a set of sensors measuring different species. The read sensor reading or data are afterward compiled in a step 491. The compilation includes downloading a response curve from the smart card memory for the sensor of the sensor cartridge 454 in a form of a look-up table. The look-up table is later used by the smart card reader 465 to convert its electrical current or voltage measurements to meaningful readings in the form of specie or concentration with the appropriate measurement unit.
These compiled reading is then transferred via USB protocol to a computer that is connected to the portable laboratory unit 450 in a step 494. Computer software afterward analyses and displays a finding of the sensor readings in tables and/or in graphs in a step 497. The compiled data are then aggregated and are saved locally in the computer in patient records in a step 500. The compiled data can also be printed subsequently. The compiled data can also be prepared for transferring a standard protocol, such as HL7, in a step 506. The prepared data are transferred to an external device in a step 509. The prepared data can be also transferred to a remote repository or to remote patient records in a step 512. The prepared data can also be emailed to the patient or to an appropriate third party.
After this, the casing of the laboratory unit 450 is opened for discarding the sensor cartridge 454 in a step 503. Several examples of this embodiment are possible.
In one example, tests for cardiac markers to assess an acute myocardical condition needs to be conducted. The myocardical condition refers to a muscular tissue of the heart. An doctor can have a dedicated cartridge with relevant biosensors to perform these various tests using merely one cartridge, since the same cartridge has sensors to measure serum concentration of Troponin, CK-MB, BNP or NT-proBNP, Prothrombin Time/INR and to deliver the findings at the point of patient care.
In another example, testing of liver function is conducted using a dedicated cartridge, which has embedded sensors to measure Gamma-GT (Gamma-glutamyl transpeptidase), ASAT (aspartate aminotransferase) , ALAT (Alanine transaminase) , Bili- rubine and to perform a Protein Electrophoresis. The electrophoresis refers to a technique used to separate different elements of a blood sample into individual components. The serum protein electrophoresis (SPEP) is a screening test that measures the major blood proteins by separating them into five distinct fractions: albumin, alphal, alpha2, beta, and gamma proteins. The protein electrophoresis can also be performed on urine. A system of the smart card reader 456 with different cartridge modules 454 is provided below. These cartridge modules 494 are produced by different manufacturers. The cartridge modules 494 have different sensor response curves and are yet work the same smart card reader 456 since these cartridge modules 494 store its own sensor response curves.
This is different from a closed system of monitoring sensors and readers, which can lead to a monopoly that provides a higher cost of blood analysis for the end-patient as well as a higher cost for the supporting medical insurances companies.
In the closed system, parameters of the monitoring sensors are coded in a firmware of sensor reader hardware. These parameters comprise species data, responses curve data, and measurement protocol data. The monitoring sensor is adapted to work only with a specific reader that has necessary sensor response curves and necessary sensor protocol for a given and often unique type of sensor unit of the monitoring sensor.
This would then lead to a high development cost of the sensor readers as well as a captive market for the monitoring sensors that works with the given reader. The portable laboratory unit 450 can be used in a standalone mode without connecting to a computer.
Figure 3 shows an embodiment of the flow chart 465 of Figure 2. Figure 3 depicts a flow chart 520 that includes steps of the flow chart 465, wherein steps of the flow chart 465 that involves the external computer are omitted. The portable laboratory unit 450 can be used to provide several tests for different conditions.
Figure 4 shows an example of kidney condition analysis 525 using the portable laboratory unit of Figure 1. The analysis has tests or measurements for creatinine, Ph, hematocrit, glucose, BUN/Urea, chloride, potassium, and sodium. These measurements may be repeated a number of times. Figure 5 shows am example of cardiac post-op condition analysis 530 using the portable laboratory unit of Figure 1. The analysis has tests for B-Type Natriuretic Peptide/ BNP, Cardiac Troponin 1/ cTnl, Kaolin ACT, Prothrombin Time PT/INR, Celite Activated Clottng time, Creatinine, PC02 and, pH.
Figure 6 shows a table 535 of possible values for the measurements of Figures 4 and 5.
Figure 7 shows a pin connection table 540 for. the portable laboratory unit of Figure 1. The table 540 depicts a contact- pin connection list for a sensor cartridge 454 with 40 pin, wherein
- pins 1 to 32 are assigned for sensors, four pins being assigned to one sensor,
- pins 33 to 36 are assigned for smart card memory, and
- pins 37 to 40 are assigned for temperature control and sensing.
The set of pins 37 to 40 is often important for precise specie analysis due to dependencies of reaction rates with temperature, which is shown by Arrhenius equation. The order of sensor in the table 540 depends on the cartridge manufacturing as well as on specific species of interest. In a case of a quasi-sensor for Ph and for Hematocrit, the first set of sensors is often important for blood related analysis due to the importance of the sensitivity of the reactivity of the species of interest with pH and blood cell count.
The embodiment provides a single means to perform various laboratory tests for a specific human organ or a specific human function in a logical and a practical way. The means uses biological fluids, which includes whole blood or serum.
This means is different from other means of testing an organ function of a living human being, which requires performing various laboratory tests using various techniques, technology platforms, devices, and skills. Moreover, such laboratory tests might be done in different geographical locations. Logistics of these tests would then cumbersome, especially for the prescribing doctor who may have to wait for different findings of a patient to be provided by the laboratory tests before proceeding with medical treatment of the patient.
A portable laboratory can be provided with more one chemical reagent actuator to provide additional features.
Figure 8 shows a portable laboratory 545 with a multi- analysis cartridge 556 for blood analysis. The laboratory 545 comprises one blood sample actuator 548, two independent biosensor chemical actuators 551 and 554, and a portable base analyzer 559. The blood sample actuator 548 is placed next to the biosensor chemical actuators 551 and 554 while the biosensor chemical actuators 551 and 554 are placed next to the multi-analysis cartridge 556. The multi-analysis cartridge 556 is placed next to the portable base analyzer 559.
In a generic sense, the portable laboratory 545 can include two or more blood sample actuators, instead of one blood sample actuator 548. The portable laboratory 545 can include more than two biosensor chemical actuators and not just two biosensor chemical actuators. In use, the multi-analysis cartridge 556 provides a means to receive a blood sample. The portable laboratory 545 provides a means to analyze this blood sample.
In particular, the cartridge 556 is used for receiving a blood sample. The blood sample actuator 548 is used for providing a force from a user to the cartridge 556 for dispersing the blood sample into channels and reservoirs within the cartridge 556. Similarly, the biosensor chemical actuators 551 and 554 are used for transmitting a force from a user to the cartridge 556 for dispersing chemical reagents into channels and reservoirs within the cartridge 556. The chemical actuators 551 and 554 are adapted to move independent of each other.
The chemical reagent is intended for mixing with the blood sample to a mixture, wherein the mixture is measured by a sensor. The portable base analyzer 559 is used for obtaining the sensor measurements to provide a finding or a test result of the blood sample.
In a generic sense, the blood sample actuator 548 and the biosensor chemical actuators 551 and 554 can be forced by an electric motor or by a hydraulic motor instead of being forced manually.
Different embodiments of the multi-analysis cartridge 556 of the portable laboratory 545 of Figure 8 are possible.
Figure 9 shows a first embodiment of the multi-analysis cartridge 556. Figure 9 depicts a multi-analysis cartridge 565. The cartridge 565 comprises a blood sample reservoir 568, a first chemical reagent reservoir 571 and a second chemical reagent reservoir 574, as well as a first waste reservoir 577 and a second waste reservoir 580. The first chemical reagent reservoir 571 is connected to the first waste reservoir 577 by a channel 583 while the first waste reservoir .577 is connected to the second waste reservoir 580 by a channel 586. A channel 589 connects the blood sample reservoir 568 to the channel 583. A sensor 590 is placed at the intersection of the channel 583 and the channel 589. Similarly, a channel 592 connects the second chemical reagent reservoir 574 to the channel 586. A sensor 594 is placed at the intersection of the channel 586 and the channel 592.
In use, the cartridge 556 is adapted to work with the portable laboratory 545 of Figure 8, wherein the blood sample reservoir 568 is intended for actuating by the blood sample actuator 548 of Figure 8. The first chemical reagent reservoir 571 and the second chemical reagent reservoir 574 are intended for actuating by the biosensor chemical actuator 554 of Figure 8. The first waste reservoir 577 is intended for actuating by the biosensor chemical actuator 551 of Figure 8. Specifically, the blood sample reservoir 568 is used for receiving a blood sample. The blood sample reservoir 568 is also used for dispersing the received blood sample into the first waste reservoir 577 via the channels 583 and 589 when it is actuated.
The first chemical reagent reservoir 571 is used for storing a first chemical reagent. The first chemical reagent reser- voir 571 is also adapted for dispersing the first chemical reagent into the first waste reservoir 577 via the channel 583 when it is actuated.
The first chemical reagent is used for mixing with the blood sample such that measurements of this mixture are used to provide a finding or a test result of the blood sample.
The intersection of the channels 583 and 589 serves as an area where the blood sample mixes and interacts with the first chemical reagent to form a first mixture. The sensor 590 is used for measuring the first mixture. The sensor measurement then acts to provide a finding or a test result of the blood sample. In a similar manner, the first waste reservoir 577 is adapted for receiving the first mixture. It is also adapted for dispersing the first mixture into the second waste reservoir 580 via the channel 586 when it is actuated. The second chemical reagent reservoir 574 is used for storing a second chemical reagent. It is also used for dispersing the second chemical reagent into the second waste reservoir 580 via the channels 592 and 586 when it is actuated. The intersection of the channels 586 and 592 serves as an area where the first mixture mixes or interacts with second chemical reagent to form a second mixture. The sensor 594 is used for measuring the second mixture. Sensor measurements of the second mixture are used providing another finding of the blood sample.
In a generic sense, the cartridge 556 can be adapted such that the blood sample can be mixed with more than two chemical reagents.
The portable laboratory working with the cartridge 556 can also include a heater for elevating the first mixture or the second mixture for a period. In addition, the portable laboratory can also include processor to measure the first or the second mixture only after a certain period.
This cartridge 556 allows the blood sample to be subjected to a string of chemical reagents. In other words, the blood sample can be subjected to a process of chemical testing. This is different from other cartridge that allows a blood sample to be subjected to just. one chemical testing. A method of using the cartridge 556 is provided below. The method includes a step of the blood sample reservoir 568 receiving a blood sample for a patient.
The cartridge 556 is then placed inside an open casing of a portable laboratory. The placing initials the sensors 590 and 594 in which electrical current and/or voltage is provided to the sensors 590 and 594. The portable laboratory casing is then closed. The closing actuates the first chemical reagent reservoir 571 such that the first chemical reagent is dispersed into the first waste reservoir 577 via the channel 583. In addition, the closing actuates the second chemical reagent reservoir 574 such that the second chemical reagent is dispersed into the second waste reservoir 580 via the channels 592 and 586.
After this, a user presses a first push button of the labora- tory casing. This pressing actuates the blood sample reservoir 568 such that the blood sample within the blood sample reservoir 568 is dispersed into the first waste reservoir 577 via the channels 589 and 583. The dispersed blood sample also mixes with the first chemical reagent within the channel 583 and the first waste reservoir 577 to form the first mixture. The sensor 590 then measures, the first mixture to provide a finding.
The user later presses a second button of the laboratory cas- ing to disperse the first mixture within the first waste reservoir 577 to the second waste reservoir 580 via the channel 586. The dispersed mixture further mixes with the second chemical agent to form the second mixture. The sensor 594 then measures the second mixture to provide another finding.
A user, such a doctor, then uses the findings to treat the patient that provides the blood sample.
Figure 10 shows a second embodiment of the multi-analysis cartridge 556 of Figure 9.
Figure 10 depicts a multi-analysis cartridge 600 that has all parts of the , multi-analysis cartridge 565 of Figure 9, where-" in the channel 589 of the cartridge 600 is connected directly to the blood sample reservoir 568 and to the first waste reservoir 577. The sensor 590 is placed inside the first waste reservoir 577. The channel 592 is connected directly to the second chemical reagent reservoir 574 and to the second waste reservoir 580. The sensor 594 is placed inside the second waste reservoir 580.
Figure 11 shows an embodiment of a casing for the portable laboratory of Figure 8.
Figure 11 depicts a portable laboratory casing 610 with a cover 615. The casing 610 has a slidable tray 620. The cover 615 has two push buttons 624 and 627 with two corresponding groups 630 and 633 of LED (Light Emitting Diode) light bulbs.
In use, the tray 620 is used for receiving a cartridge with a blood sample. The cover 615 is used for actuating chemical reagent reservoirs of the received cartridge to disperse a first chemical reagent and a second chemical reagent.
The first group 630 of LED is used for prompting a user to press the push button 624. The pressed push button 624 actuates a blood sample reservoir of the cartridge to disperse blood sample within the blood sample reservoir to mix with the first chemical reagent.
Similarly, the second group 633 of LED is used for prompting the user to press the push button 627. The pressed push but- ton 627 then actuates a reservoir of the cartridge to disperse the mixture of the blood sample and the chemical reagent to mix with the second chemical reagent . Although the above description contains much specificity, these should not be construed as limiting the scope of the embodiments but merely providing illustration of the foresee- able embodiments. Especially the above stated advantages of the embodiments should not be construed as limiting the scope of the embodiments but merely to explain possible achievements if the described embodiments are put into practice. Thus, the scope of the embodiments should be determined by the claims and their equivalents, rather than by the examples given.
The embodiments can also be described with the following lists of elements being organized into items. The respective combinations of features which are disclosed in the item list are regarded as independent subject matter, respectively, that can also be combined with other features of the application . 1. A laboratory comprising a portable casing, the portable casing comprising
a tray unit for receiving a cartridge, the cartridge comprising .
an analyte reservoir for receiving an an- alyte fluid,
at least one chemical reagent reservoir for storing at least one chemical reagent fluid,
at least one channel connecting the at least one chemical reagent reservoir with the analyte reservoir, the channel comprising a measurement area, the measurement area comprises a sensor, and a memory device with cartridge data, a memory device reader for retrieving the cartridge data from the cartridge,
an actuator unit for interacting with the cartridge such that the volume of the analyte reservoir and the volume of the at least one chemical reagent reservoir is reduced,
an analyzer unit for interacting with the cartridge such that a physical value in the measurement area is measured using the sensor in accordance to the cartridge data, and
a communication unit for outputting the physical value.
The laboratory according to item 1, wherein
the actuator unit is adapted for interacting with the cartridge such that the volume of the analyte reservoir and the volume of the at least one chemical reagent reservoir are reduced in accordance to the cartridge data.
The laboratory according to item 1 or 2, wherein the actuator unit comprises an analyte actuator for interacting with the. cartridge such that the volume of the analyte reservoir is reduced and a chemical reagent actuator for interacting with the cartridge such that the volume of the at least one chemical reagent reservoir is reduced.
A laboratory comprising a portable casing, the portable casing comprising
a tray unit for receiving a cartridge, the cartridge comprising an analyte reservoir for receiving an an- alyte fluid,
a first chemical reagent reservoir for storing a first chemical reagent fluid, a first mixture reservoir for receiving the analyte fluid with the first chemical reagent fluid via a first channel network,
a second chemical reagent reservoir for storing a second chemical reagent fluid, and
a second mixture reservoir for receiving the analyte fluid with the first chemical reagent fluid from the first mixture reservoir and the second chemical reagent fluid via a second channel network, the second channel network comprises a measurement area, the measurement area comprises a sensor,
an actuator unit for interacting with the cartridge such that the volume of the analyte reservoir, the volume of the first chemical reagent reservoir with the second chemical reagent reservoir, and the volume of the first mixture reservoir are reduced,
an analyzer unit for interacting with the cartridge such that a physical value in the measurement area is measured using the sensor, and
a communication unit for outputting the physical value .
The laboratory according to item 4, wherein
the first channel network comprises a measurement area that comprises a sensor, the analyzer unit interacts with the cartridge such that a physical value in the measurement area is measured using the sensor.
The laboratory according to item 4 or 5, wherein the portable casing further comprising a memory device reader for retrieving cartridge data from the cartridge, the analyzer unit interacts with the cartridge such that the physical value in the measurement area is measured using the sensor in accordance to the cartridge data.
The laboratory according to one of items 4 to 6, wherein the actuator unit is adapted for interacting with the cartridge such that the volume of the analyte reservoir, the volume of the first chemical reagent reservoir and the volume of the second chemical reagent reservoir, and the volume of the first mixture reservoir are reduced in accordance to the cartridge data.
The laboratory according to one of items 4 to 7, wherein the actuator unit comprising
an analyte actuator for interacting with the cartridge such that the volume of the analyte reservoir is reduced,
a chemical reagent actuator for interacting with the cartridge such that the volume of the first chemical reagent reservoir and the volume of the second chemical reagent reservoir are reduced, and
a mixture reservoir actuator for interacting with the cartridge such that the volume of the first mixture reservoir is reduced.
The laboratory according to one of the aforementioned items, wherein the actuator unit comprises at least one push area for manual actuation by a user of the laboratory.
The laboratory according to one of the aforementioned items, wherein
the tray is provided as a movable tray.
The laboratory according to the aforementioned items, wherein
the . communication unit comprises a Subscriber Identity Module (SIM) card interface.
A personal health hub comprising
a laboratory of one of the aforementioned items, a computing device connecting to the laboratory fo retrieving at least one result of the laboratory, and a device accessible by the computing device for storing the at least one result of the laboratory.
A method of using a portable laboratory comprising
storing cartridge data in a cartridge,
providing the cartridge with an analyte fluid, and placing the cartridge in the portable laboratory for analyzing the analyte fluid, the analysis comprisin retrieving the cartridge data from the cartridge,
driving the analyte fluid to fill at least one channel and driving at least one chemical reagent fluid to fill the a least one channel such that the analyte fluid mixes with the at least one chemical reagent fluid to form at least one mixture, measuring at least one value of the at least one mixture in accordance to the cartridge data,
determining a result of the analyte fluid using the at least one measured value, and
outputting the result.
The method according to item 13, wherein
the analyte fluid is driven to fill at least one channel and the at least one chemical reagent fluid is driven to fill the at least one channel in accordance to the cartridge data.
A method of using a portable laboratory comprising
providing the cartridge with an analyte fluid and placing the cartridge in the portable laboratory for analyzing the analyte fluid, the analysis comprising driving the analyte fluid and a first chemical reagent fluid to fill a first mixture reservoir such that the analyte fluid mixes with the first chemical reagent fluid to form a first mixture, driving the first mixture and a second chemical reagent fluid to fill the second mixture reservoir, such that the first mixture mixes with the second chemical reagent fluid to form a second mixture, measuring at least one value of the second mixture,
- determining a result of the analyte fluid using the at least one measured value, and outputting the result.
The method according to item 15, wherein
- the analysis further comprises measuring at least one value of the first mixture and wherein
- the analysis is characterized in that the result of the analyte fluid is determined using the at least one measured value of the first mixture and the at least one measured value of the second mixture.
The method according to item 15 or 16, wherein
the method further comprises
- storing cartridge data in a cartridge,
- retrieving the cartridge data from the cartridge,
- measuring at least one value of the first or the cond mixture in accordance to the cartridge data.
The method according to one of items 15 to 17, wherein the analyte fluid with the first chemical reagent fluid is driven to fill a first mixture reservoir and the first mixture with the second chemical reagent fluid is driven to fill the second mixture reservoir in accordance to the cartridge data.
The method according to one of items 13 to 18, wherein the result of the analyte fluid is determined using the at least one measured value in accordance to the cartridge data.
20. The method according to one of items 13 to 19, wherein the analysis further comprising
heating the analyte fluid. 21. The method according to one of items 13 to 20, wherein the analysis further comprising
measuring temperature of the analyte fluid. 22. The method according to one of items 13 to 21, wherein the result is outputted to at least one light.
The method according to one of items 13 to 22, wherein the result is outputted to an external computing device
A cartridge for a portable laboratory, the cartridge comprising
an analyte reservoir for receiving an analyte fl at least one chemical reagent reservoir for storing at least one chemical reagent fluid,
at least one channel connecting the at least one chemical reagent reservoir with the analyte reservoir, the channel comprising a measurement area, the measurement area comprises a sensor for measuring a physical value in the measurement area and electrical contacts for accessing the sensor,
an analyte contact area in the vicinity of the analyte reservoir, the analyte area being provided for contacting with an actuator unit for reducing the volume of the analyte reservoir,
at least one chemical reagent contact area in the vicinity of the at least one chemical reagent reservoir, the at least one chemical reagent contact area being provided for contacting with the actuator unit for reducing the volume of the at least one chemical reagent reservoir, and
a memory device with cartridge data. The cartridge according to item 24, wherein
the cartridge data further comprises data for actuating the analyte contact area and the least one chemical rea gent contact area. The cartridge according to item 24 or 25, wherein the cartridge data is encrypted.
A cartridge for a portable laboratory, the cartridge comprising
an analyte reservoir for receiving an analyte fluid,
a first chemical reagent reservoir for storing a first chemical reagent fluid,
a first mixture reservoir for receiving the analyte fluid with the first chemical reagent fluid via a first channel network,
a second chemical reagent reservoir for storing a second chemical reagent fluid,
a second mixture reservoir for receiving the analyte fluid with the first chemical reagent fluid and the second chemical reagent fluid via a second channel network, the second channel network comprises a measurement area, the measurement area comprises a sensor for measuring a physical value in the measurement area and electrical contacts for accessing the sensor,
an analyte reservoir contact area in the vicinity of the analyte reservoir, the analyte reservoir contact area being provided for contacting with an analyte actuator for reducing the volume of the analyte reservoir, a first chemical reagent contact area in the vicinity of the first chemical reagent reservoir, the first chemical reagent contact area being provided for contacting with a first chemical reagent actuator for reducing the volume of the first chemical reagent reservoir,
a second chemical reagent contact area in the vicinity of the second chemical reagent reservoir, the second chemical reagent contact area being provided for contacting with a second chemical reagent actuator for reducing the volume of the second chemical reagent reservoir, and
a first mixture reservoir contact area in the vicinity of the first mixture reservoir, the first mixture reservoir contact area being provided for contacting with a first mixture reservoir actuator for reducing the volume of the first mixture reservoir.
The cartridge according to item 27 further comprising a memory device with cartridge data.
The cartridge according to item 27 or 28, wherein the cartridge data further comprises data for actuating the analyte contact area, the first chemical reagent contact area, the second chemical reagent contact area, and the first mixture reservoir contact area.
The cartridge of one of items 24 to 29, wherein the cartridge further comprises a waste analyte reservoir and at least one chemical waste reservoir, the waste analyte reservoir is connected to the analyte reservoir an analyte channel, the chemical reagent waste reservoir is connected to the chemical reservoir via a chemical reagent waste channel. The cartridge according to one of items 24 to 30, wherein
the measurement area comprises a measurement reservoir.
The cartridge according to one of items 24 to 31 further comprises a heater.
The cartridge according to one of items 24 to 32 further comprises a temperature sensor.
A cartridge unit for performing at least one test for a biological organ comprising
a cartridge according to one of items 24 to 33, the cartridge comprising at least one sensor, wherein the sensor measures at least one physical value of the biological organ.
Reference Numbers
450 portable laboratory unit
454 cartridge module
456 smart card reader
458 smart card
459 memory device
465 flow chart
470 step
473 step
476 step
479 step
482 step
485 step
488 step
491 step
494 step
497 step
500 step
503 step
506 step
509 step
512 step
520 flow chart
525 analysis
530 analysis
535 table
540 table
545 portable laboratory
548 blood sample actuator
551 biosensor chemical actuator
554 biosensor chemical actuator
556 multi-analysis cartridge 559 portable base analyzer
565 cartridge
568 blood sample reservoir
571 chemical reagent reservoir
574 chemical reagent reservoir
577 waste reservoir
580 waste reservoir
583 channel
586 channel
589 channel
590 sensor
592 channel
594 sensor
600 cartridge
610 casing
615 cover
620 tray
624 push button
627 push button
630 group of LED light bulbs.
633 group of LED light bulbs.

Claims

Claims
A laboratory comprising a portable casing, the portable casing comprising
a tray unit for receiving a cartridge, the cartridge comprising
an analyte reservoir for receiving an analyte fluid,
at least one chemical reagent reservoir for storing at least one chemical reagent fluid,
at least one channel connecting the at least one chemical reagent reservoir with the analyte reservoir, the channel comprising a measurement area, the measurement area comprises a sensor, and
- a memory device with cartridge data, a memory device reader for retrieving the cartridge data from the cartridge,
an actuator unit for interacting with the cartridge such that the volume of the analyte reservoir and the volume of the at least one chemical reagent reservoir is reduced,
an analyzer unit for interacting with the cartridge such that a physical value in the measurement area is measured using the sensor in accordance to the cartridge data, and
a communication unit for outputting the physical value .
The laboratory according to claim 1, wherein
the actuator unit is adapted for interacting with the cartridge such that the volume of the analyte reservoir and the volume of the at least one chemical reagent reservoir are reduced in accordance to the cartridge data.
The laboratory according to claim 1, wherein
the actuator unit comprises an analyte actuator for interacting with the cartridge such that the volume of the analyte reservoir is reduced and a chemical reagent actuator for interacting with the cartridge, such that the volume of the at least one chemical reagent reservoir is reduced.
A laboratory comprising' a portable casing, the portable casing comprising
a tray unit for receiving a cartridge, the cartridge comprising
an analyte reservoir for receiving an analyte fluid,
• a first chemical reagent reservoir for storing a first chemical reagent fluid, a first mixture reservoir for receiving the analyte fluid with the first chemical reagent fluid via a first channel network,
a second chemical reagent reservoir for storing a second chemical reagent fluid, and
a second mixture reservoir for receiving the analyte fluid with the first chemical reagent fluid from the first mixture reservoir and the second chemical reagent fluid via a second channel network, the second channel network comprises a meas- urement area, the measurement area comprises a sensor,
an actuator unit for interacting with the cartridge such that the volume of the analyte reservoir, the vol- ume of the first chemical reagent reservoir with the second chemical reagent reservoir, and the volume of the first mixture reservoir are reduced,
an analyzer unit for interacting with the cartridge such that a physical value in the measurement area is measured using the sensor, and
a communication unit for outputting the physical value.
The laboratory according to claim 4, wherein
the first channel network comprises a measurement area that comprises a sensor, the analyzer unit interacts with the cartridge such that a physical value in the measurement area is measured using the sensor.
The laboratory according to claim 4, wherein
the portable casing further comprising a memory device reader for retrieving cartridge data from the cartridge, the analyzer unit interacts with the cartridge such that the physical value in the measurement area is measured using the sensor in accordance to the cartridge data.
The laboratory according to claim 4, wherein
the actuator unit is adapted for interacting with the cartridge such that the volume of the analyte reservoir, the volume of the first chemical reagent reservoir and the volume of the second chemical reagent reservoir, and the volume of the first mixture reservoir are reduced in accordance to the cartridge data. The laboratory according to claim 4, wherein
the actuator unit comprising
an analyte actuator for interacting with the cartridge such that the volume of the analyte reservoir is reduced,
a chemical reagent actuator for interacting with the cartridge such that the volume of the first chemical reagent reservoir and the volume of the second chemical reagent reservoir are reduced, and
a mixture reservoir actuator for interacting with the cartridge such that the volume of the first mixture reservoir is reduced.
The laboratory according to claim 1, wherein
the actuator unit comprises at least one push area for manual actuation by a user of the laboratory.
The laboratory according to claim 1, wherein
the tray is provided as a movable tray.
The laboratory according to claim 1, wherein
the communication unit comprises a Subscriber Identity
Module (SIM) card interface.
A personal health hub comprising
a laboratory of claim 1,
a computing device connecting to the laboratory for retrieving at least one result of the laboratory, and a device accessible by the computing device for storing the at least one result of the laboratory.
13. A method of using a portable laboratory comprising storing cartridge data in a cartridge,
providing the cartridge with an analyte fluid, and placing the cartridge in the portable laboratory for analyzing the analyte fluid, the analysis comprising retrieving the cartridge data from the cartridge,
driving the analyte fluid to fill at least one channel and driving at least one chemical reagent fluid to fill the at least one channel such that the analyte fluid mixes with the at least one chemical reagent fluid to form at least one mixture,
measuring at least one value of the at . least one mixture in accordance to the cartridge data,
determining a result of the analyte fluid using the at least one measured value, and
outputting the result.
The method according to claim 13, wherein
the analyte fluid is driven to fill at least one channel and the at least one chemical reagent fluid is driven to fill the at least one channel in accordance to the cartridge data.
15. A method of using a portable laboratory comprising
providing the cartridge with an analyte fluid and placing the cartridge in the portable laboratory for analyzing the analyte fluid, the analysis comprising driving the analyte fluid and a first chemical reagent fluid to fill a first mixture reservoir such that the analyte fluid mixes with the first chemical reagent fluid to form a first mixture, driving the first mixture and a second chemical reagent fluid to fill the second mixture reservoir, such that the first mixture mixes with the second chemical reagent fluid to form a second mixture, measuring at least one value of the second mixture,
determining a result of the analyte fluid using the at least one measured value, and
outputting the result.
The method according to claim 15, wherein
- the analysis further comprises measuring at least one value of the first mixture and wherein
- the analysis is characterized in that the result of the analyte fluid is determined using the at least one measured value of the first mixture and the at least one measured value of the second mixture .
The method according to claim 15, wherein
the method further comprises
- storing cartridge data in a cartridge,
- retrieving the cartridge data from the cartridge, and
- measuring at least one value of the first or the second mixture in accordance to the cartridge data.
The method according to claim 15, wherein
the analyte fluid with the first chemical reagent fluid is driven to fill a first mixture reservoir and the first mixture with the second chemical reagent fluid is driven to fill the second mixture reservoir in accordance to the cartridge data.
The method according to claim 13, wherein
the result of the analyte fluid is determined using the at least one measured value in accordance to the cartridge data.
The method according to claim 13, wherein
the analysis further comprising
heating the analyte fluid.
The method according to claim 13, wherein
the analysis further comprising
measuring temperature of the analyte fluid.
The method according to claim 13, wherein
the result is outputted to at least one light.
The method according to claim 13, wherein
the result is outputted to an external computing device.
A cartridge for a portable laboratory, the cartridge comprising
an analyte reservoir for receiving an analyte fluid,
at least one chemical reagent reservoir for storing at least one chemical reagent fluid,
at least one channel connecting the at least one chemical reagent reservoir with the analyte reservoir, the channel comprising a measurement area, the measurement area comprises a sensor for measuring a physical value in the measurement area and electrical contacts for accessing the sensor,
an analyte contact area in the vicinity of the ana- lyte reservoir, the analyte area being provided for contacting with an actuator unit for reducing the volume of the analyte reservoir,
at least one chemical reagent contact area in the vicinity of the at least one chemical reagent reservoir, the at least one chemical reagent contact area being provided for contacting with the actuator unit for reducing the volume of the at least one chemical reagent reservoir, and
a memory device with cartridge data.
The cartridge according to claim 24, wherein
the cartridge data further comprises data for actuating the analyte contact area and the least one chemical reagent contact area.
The cartridge according to claim 24, wherein
the cartridge data is encrypted.
A cartridge for a portable laboratory, the cartridge comprising
an analyte reservoir for receiving an analyte fluid,
a first chemical reagent reservoir for storing a first chemical reagent fluid,
a first mixture reservoir for receiving the analyte fluid with the first chemical reagent fluid via a first channel network,
a second chemical reagent reservoir for storing a second chemical reagent fluid, a second mixture reservoir for receiving the analyte fluid with the first chemical reagent fluid and the second chemical reagent fluid via a second channel network, the second channel network comprises a measurement area, the measurement area comprises a sensor for measuring a physical value in the measurement area and electrical contacts for accessing the sensor,
an analyte reservoir contact area in the vicinity of the analyte reservoir, the analyte reservoir contact area being provided for contacting with an analyte actuator for reducing the volume of the analyte reservoir, a first chemical reagent contact area in the vicinity of the first chemical reagent reservoir, the first chemical reagent contact area being provided for contacting with a first chemical reagent actuator for reducing the volume of the first chemical reagent reservoir,
a second chemical reagent contact area in the vicinity of the second chemical reagent reservoir, the second chemical reagent contact area being provided for contacting with a second chemical reagent actuator for reducing the volume of the second chemical reagent reservoir, and
a first mixture reservoir contact area in the vicinity of the first mixture reservoir, the first mixture reservoir contact area being provided for contacting with a first mixture reservoir actuator for reducing the volume of the first mixture reservoir.
The cartridge according to claim 27 further comprising a memory device with cartridge data.
The cartridge according to claim 27, wherein the cartridge data further comprises data for actuating the analyte contact area, the first chemical reagent contact area, the second chemical reagent contact area, and the first mixture reservoir contact area.
30. The cartridge claim 24, wherein
the cartridge further comprises a waste analyte reservoir and at least one chemical waste reservoir, the waste analyte reservoir is connected to the analyte res- ervoir an analyte channel, the chemical reagent waste reservoir is connected to the chemical reservoir via a chemical reagent waste channel.
31. The cartridge according to claim 24, wherein
the measurement area comprises a measurement reservoir.
32. The cartridge according to claim 24 further comprising a heater. 33. The cartridge according to claim 24 further comprising a temperature sensor.
34. ' A cartridge unit for performing at least one test for a biological organ comprising
a cartridge according to claim 24, the cartridge comprising at least one sensor, wherein the sensor measures at least one physical value of the biological organ.
PCT/SG2011/000381 2010-10-28 2011-10-28 On-chip laboratory for blood analysis WO2012057712A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IB2010054881 2010-10-28
IBPCT/IB2010/054881 2010-10-28

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Publication number Priority date Publication date Assignee Title
US20020045243A1 (en) * 2000-09-15 2002-04-18 Laska Ronald C. Fluid cartridge and method
US20100029011A1 (en) * 2002-06-28 2010-02-04 Kee Van Sin Analytical test cartridge; and, methods
US20090008253A1 (en) * 2004-06-04 2009-01-08 Crystal Vision Microsystems Llc Device and Process for Continuous On-Chip Flow Injection Analysis
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