Background technology
In the discussion hereinafter, with reference to some structure and/or method.Yet reference hereinafter should not be construed as admits that these structures and/or method constitute prior art.The applicant clearly keeps the right that demonstration this structure and/or method are not defined as prior art.
The instrument of known many different configurations.For example, the information of environment or unit or (respectively) material in the instrument of some type control experiment or the self-test of collecting.Only as example, this instrument comprises digital multimeter, oscillograph, DNA sequence analyser, pressure transducer, temperature sensor, pH sensor etc.
In the past, the instrument discrete instrument (as centrifugal separator or spectrophotometer) that has been exclusively used in simple function and manually operation from use has been developed to the instrument system of a plurality of processing integrated.This multiprocessing instrument typically need manually be carried out the rapid processing of complexity or multistep to move each instrument by the user.In some cases, make great efforts the discrete instrument system of combination and make it robotization, to reduce cost and throughput rate is provided.The example of the instrument of this combination comprises the integrated of large-scale fluid treatment robotization (robotic) workstation.Fig. 1 shows the calcspar of the example system 100 with complete reusable instrument 110, described instrument 110 comprises all operation parts (for example, user interface, CPU/ control system, detector system, processing controller, fluid treatment, data storage and power module).
In order to reduce sample cross contamination, in many application, adopted as the disposable unit of plastic tube, well dish (wellplate) and centrifuge tube to replace fixed sample processing element as some instruments of pipeline and fluid container.
Many advantages of miniaturization have caused splits the interest that day by day increases of hair in the microsystem of integral instrument parts.Especially, aspect robotization, repeatability, speed, cost and size, can on the instrument of traditional experiment chamber, realize improvement in performance.
Developed microfluid (microfluidic) parts as the effective substitute of the cost of silicon, be used for the simple disposable unit of instrument system based on polymkeric substance.Yet these systems are limited on complicacy and integrated level, because they comprise fluid handling component, sensor and the actuator (actuator) of external drive.United States Patent (USP) 6,900,889,6,810,713 and 6,408,878 and U.S. Patent Application Publication 2004/209354A and 2002/0148992A1 show the embodiment of this system.Fig. 2 shows the calcspar of the example system 200 that comprises reusable instrument 210, but described instrument 210 comprises all operations parts (for example, user interface, CPU/ control system, detector system, processing controller, data storage and power module) the fluid handling component on being positioned at removable consumer device 205.
Equally developed the microfluidic device based on polymkeric substance, it incorporates plate set sensor and the actuator that is connected to external instrument into, as at United States Patent (USP) 6,073, and 482,6,896,778 and 6,103, those described in 033.The limitation of this equipment comprises reliability, relate to the problem that connects with connector and with the long relevant problem (for example, electromagnetic interference (EMI) and magnetic susceptibility, line impedence, encapsulation and equipment size) of mutual connection.
Known smart card polymer devices comprises memory module, and also be included in personal identification in some cases, CPU (central processing unit) (CPU) that security and payment are used in using.The example of this smart card is described in the ISO 7816 and ISO 7501 standards that are used for I.D., be used for from ISO 14443, the ISO 10536 of the rfid card of standardized international organization and ISO 15693 standards and from the GSM 11.11 of the global system that is used for mobile communication standard.Smart card can be classified with the interface type that they are used for communicating by letter with external instrument according to the chip type that they comprised.Usually, there are the three kind dissimilar chips relevant, comprise based on the smart card of storer, hard wired logic and microcontroller only with smart card according to the function grouping that they provided.
Only the smart card of storer comprises the storage card of serial protection.This card provides data storage capacities in the mode that is similar to magnetic stripe card, but has bigger data storage capacity, and can be used for than the jig based on magnetic fetch equipment more cheaply being arranged.Only the storer smart card does not comprise logical OR execution calculating, yet, also use some cards that also have the data protection feature to store data simply.
The hard wired logic smart card comprises the state machine of logic-based, and it provides encryption and authentication visit to card memory and its content.The hard wired logic smart card has supports the static file systems of using more, and it has the optional encrypted access to memory content, but command group relevant with these cards and file structure are only to change by the integrated circuit (IC) on the redesign card.Fig. 3 illustrates the calcspar of the example system 300 that comprises instrument 310, and this instrument 310 is connected with chip card 305, the inclusive disjunction data storage.
The microcontroller smart card that is commonly referred to " smart card " comprises the microcontroller with operating system.Microcontroller according to its operating system actuating logic, calculate and store data, and plate carries storer and can upgrade repeatedly.Fig. 4 shows the calcspar of the example system 400 that comprises instrument 410, and this instrument 410 is connected with smart card 405, comprises CPU and data-carrier store.
The smart card of all these types needs the external instrument interface to operate, and it can contact or contactless interface according to how realizing being electrically connected being categorized as.Smart card can provide two types interface by chip (being sometimes referred to as " hybrid card ") or the double nip chip that uses two kinds to separate.
Known smart card, and the current hull cell that is used for this card of just researching and developing with internal electric source.Described smart card and be used for memory stores, as be used for back-up application with internal electric source.For example, United States Patent (USP) 6,854,657 have described the double cell configuration that is used for field programmable preface smart card that allows to use volatile memory.
Become known for the smart card device of autonomy (autonomous) operation equally.For example, " the supper-intelligent card " of incorporating graphical user interface (GUI) and interactive element into is confirmed, and incorporate microprocessor into usually, storer, battery, LCD (LCD) and film keyboard device.Though these equipment show the function of the growth on standard chips and smart card, all confirm to have sensor or actuator control or have a fluidic component integrated.
Known have the smart card that plate carries biologicall test fingerprint sensor interface and be used for some Secure Application.For example, United States Patent (USP) 6,848,617 have described the fingerprint sensor module that is used to insert smart card, and United States Patent (USP) 6,325,285 has been described the smart card that comprises storer, microprocessor, I/O (I/O) and fingerprint biometric sensor parts.The open WO00161638A1 of international patent application has described the more common smart card that is used for the biologicall test sensing, it is connected with inside that is used for measurement data or external sensor, but because comprising, equipment do not provide actuator operated or sensor control or feedback, so functions of the equipments are confined to basic sensor data acquisition.
United States Patent (USP) 6,454,708 have described another example as the smart card of sensing system part operation.Smart card is connected with patient's cardiogram (ECG) equipment on one's body, makes card is being sent to before external instrument is used for monitoring and handles, and the ECG data are collected and are stored on the card.The limitation of this configuration is: it only is applied to the ECG DATA REASONING, even and some interface electronics can be placed on the card that plate carries, card is storage ECG data of being gathered only also.
In addition, United States Patent (USP) 6,896,778 have described and have used the blank intelligent card chip carrier module with electrode, and this electrode has the semi-permeable diaphragm of direct contact internal fluid channels.Yet this equipment does not provide any sub-device of chip power or integrated circuit that is connected with sensor or actuator component, only allows very limited robotization and integrated with external instrument.U.S. Patent application 2005/0031490 has been described the sensor chip on the smart card electrode module, wherein silicon sensor comprises the Integrated electrode array with multiplexer and amplifier of himself, and sensor chip is packed to have the sensitizing range and the electrical connection relevant with the smart card electrode module that is exposed to fluid.Though, similar United States Patent (USP) 6,896,778, the system of describing in U.S. Patent application 2005/0031490 still is confined to be connected directly to this single architecture of the sensor chip of intelligent card interface.
Low-cost disposable radio-frequency (RF) identification (RFID) label that is called " intelligent label " has been incorporated the sensor circuit that is useful on the supervision purpose into.For example, U.S. Patent Application Publication 2005/0088299 has been described the sensor network based on RFID, its by reader wirelessly the pick-up transducers data and with another instrument communication that is used for deal with data, and U.S. Patent Application Publication 2005/174236 has been described a kind of rfid system, it comprises transceiver, sensing system and interface, with the history run of identification during its life cycle, tracking and collection product.These equipment disposition all are limited to the operation in response to external reader, the inquiry of this external reader and carry power supply can be to the RFID sensing system, and only provide sensor and RFID data to be used for handling by external system.In addition, U.S. Patent Application Publication 2005/0248455 has been described a kind of RFID sensing system, and it is confined to Looking Out Time and temperature to determine the freshness or the shelf-life of perishable article.Though this equipment can periodically activate with the execution monitoring function from low electricity condition again, it still needs and external device communication when inquiry.
Memory member has been incorporated the microfluidic components based on polymkeric substance that is used for instrument system into, is provided by external instrument in this instrument system and controls fully and monitor.Fig. 5 show comprise except that all operations parts of fluid handling component (for example, user interface, CPU/ control system, detector system, processing controller and power module) the calcspar of typical instrument system 500, but this instrument system 500 is positioned on the removable consumer device 505 with data storage capacities.
For example, U.S. Patent Application Publication 2004/0248318 has been described the removable biochip that is positioned on the chip card with readable/writeable memory, but does not provide direct connection between fluid or chip upper sensor or actuator.Thereby storage operation has only been carried out in this configuration, and fluidic component must remove and is used to use external instrument to handle.Similarly, United States Patent (USP) 6,153,085, U.S. Patent Application Publication 2002/155033A1 and 2005/0019213 and the open WO 2003/082730A of international patent application and WO 2004/112946 microfluid system of incorporating memory member into has been described, but these equipment are confined to them only incorporates circuit block based on storer into, but do not comprise from functipnal capability, and on equipment, do not have electronic sensor and fluid system interface.Thereby, these equipment must with external instrument attended operation, thereby the restriction of the interconnection problems of being correlated with.In addition, these equipment can not carry out autonomous or even half autonomous operation, and do not provide sensor and/or actuator supervision, control, feedback or signal to strengthen.
Embodiment
General introduction
Fig. 6 A shows and is used to carry out the exemplary apparatus 600 that partial analysis is at least handled.As using herein, term " partial analysis processing " refers to such an extent that be can be by any suitable function of equipment 600 execution, including, but not limited to data storage, sample storage and test function, handle, monitor and/or analyze as physics, chemistry and/or biological chemistry.
In one embodiment, but equipment 600 can comprise consumer device.As used herein, term " can consume " a kind of equipment of having described, and it uses or definable sequence is used (as for example, the sequence blood glucose measurement) to be consumed afterwards or exhausted at single.Typically, but consumer device will be processed after this being used to complete, and perhaps can store to be used for after a while with reference to (for example, in forensic science).In another embodiment, equipment 600 can comprise microfluidic device.As used herein, term " microfluid " refer to be have that at least one dimension implements in less than about 1 millimeter structure fluid-operated, handle or handle.In another embodiment, microfluidic device comprises the electrode of non intelligent card form form, and also can comprise one or more sensors.
In another embodiment, equipment can be to incorporate electrode into the similar form of smart card electrode.Electrode can be any suitable type, and for example, electrode can meet the size of the electrode chip carrier module of ISO7816-2 standard.Fig. 6 C shows the planimetric map of the smart card module 614 of exemplary six electrodes contact 612, and Fig. 6 D shows the sectional view of the module 614 shown in Fig. 6 C.Typically, electrode 612 can comprise gold-plated conductive layer 615 and 620 on polymer carrier layer 625 either sides, and can be connected by vias630 as shown in Fig. 6 D.One side of module 614 can comprise the silicon integrated circuit 635 of encapsulation, and whole module 614 can use bonding agent 640 to be connected to plastic casing 645.In other embodiments, equipment can be incorporated electrode into the form different with the smart card electrode form.
Equipment 600 can comprise the data processor 610 of the data that are configured to the Treatment Analysis processing.Data processor can be taked any suitable form.In one embodiment, data processor comprises electronic circuit and/or integrated circuit, including, but not limited to analog regulation (conditioning) circuit, digital circuit, storer and CPU.In addition, data processor can be carried out any required data processing function, including, but not limited to monitoring, control, collect, store, handle or the transmission data.As used in this article, term " data " refers to such an extent that be any type of any Useful Information.For example, data can be electromagnetism, visual, simulation, numeral, audio frequency etc.
Alternatively, as shown in Fig. 6 B, equipment 600 can comprise enabler 611, and it can maybe can be not attached to data processor 610.Can think that enabler 611 is parts of analyzing and processing.For example, enabler 611 can comprise sample interactive elements, sample storage medium (for example, for example, absorbing medium, bubble wrap, well (well) etc.) or microfluidic element and other element.
Equipment 600 can also comprise and is configured to allow to the communicator 605 of communicating by letter with equipment 600.Equipment 600 can with any suitable object communication, including, but not limited to user/individual, instrument, another equipment and network.In one embodiment, communicator 605 comprises user interface, it (for example can comprise input, button, voice/sound identification, Vibration identification, reed switch and electric capacity and other input) and output (for example, OLED, LCD, color change or some other visual display mechanism and other outputs).In one embodiment, communicator 605 comprises tool interface system, and it can comprise for example electrode or smart card electrode module and other embodiment.Communicator 605 can be via any suitable device communication, and described device is including, but not limited to electromagnetic wave (no matter whether via physical connection), sound, light, contact (for example, by user's press push button) and pressure.
Equipment 600 can also comprise any other suitable components, as, be used to store and/or handle sample parts, be used for measurement parameter sensor (for example, biometric sensor), actuator (for example, being used to control at least a portion analyzing and processing), controller, feedback path, Signal Regulation element and RFID parts and other.
Equipment 600 can be made by any other suitable material, including, but not limited to polymkeric substance, metal, paper (paper), glass or synthetic material.Synthetic material can for example comprise polymkeric substance, metal, pottery, paper or silicon materials.In one embodiment, equipment 600 consists essentially of non-silicon materials.In another embodiment, equipment 600 comprises polymkeric substance or synthetic material.
The size of equipment 600 can be less than about 100mm * 150mm * 20mm.In another embodiment, the size of equipment 600 can be less than about 70mm * 120mm * 10mm.In another embodiment, the size of equipment 600 can be about 60mm * 90mm * 5mm.In another embodiment, the size of equipment 600 can be the size that is about credit card-sized.
Equipment 600 can use any suitable device and externally fed or self-powered.For example, can use battery, inner primary element, biologicall test, capacitive character, electrical conductance, sport dynamics, piezoelectricity and sun power obtain/memory storage comes to the equipment self-powered.
The detailed description that is used to carry out the equipment that partial analysis at least handles and is used to use the method for this equipment is provided below.Explaining will be only as exemplary embodiment, and the present invention need not be confined to this.
The data processor parts
The equipment 600 that is used to carry out the processing of partial analysis at least can comprise the data processor 610 of the data that are used for the Treatment Analysis processing, as shown in Fig. 6 A.
In one embodiment, data processor 610 comprises electronics and/or integrated circuit component, including, but not limited to using one or more simulations, numeral, power supply, radio frequency (RF) and/or microwave circuit parts discrete and/or that integrated circuit components is realized.For example, simple data processor 610 can comprise the mimic channel that can measure and be operatively connected to the sensor of instrument.In this case, data processor 610 can comprise the phototransistor that is connected to the operation amplification circuit, provides the Signal Regulation terminal to the connector on the equipment 600, is used to be connected to instrument.
In another embodiment, data processor 610 can comprise various computing elements, including, but not limited to comprising the integrated circuit of microprocessor or microcontroller.In this case, integrated circuit can comprise operating system, for example, and each version and the derived version of Linux, Microsoft Windows, PC/SC, OCF and Java.
In another alternate embodiment, data processor 610 comprises electronics and/or integrated circuit, and it can independent operation and/or is connected to external unit, including, but not limited to instrument and another equipment.In this embodiment, data processor 610 can before the use equipment 600, during or afterwards, carry out user or instrument reciprocation.For example, data processor 610 can provide the data of usefulness, including, but not limited to relate to following in one or more data: the function of device history, use, termination (expiry), manufacturing, program safety, handling safety, user's overview, calibration, result, user instruction, instrument instruction or parameter, surveillance equipment use and/or termination, reagent or composition, customer interaction, equipment operation parameter, environmental baseline, positional information and operation of equipment progress.
In another illustrative embodiment, the electronic circuit of data processor 610 and/or integrated circuit can operate to " from (slave) " configuration, and equipment 600 is connected to external instrument or another equipment in this case, and it provides the control to equipment 600.For example, Fig. 3 and 4 shows exemplary chip card and smart card device 305 and 405, and it can be by respectively in response to from the external command of instrument 310 and 410 and with from configuration operation.
In another embodiment, the electronic circuit of data processor 610 and/or integrated circuit can operate to " main (master) " configuration, and equipment 600 can independent operating and/or made decision and/or can control and the communicating by letter of miscellaneous equipment in this case.For example, Figure 11 shows exemplary apparatus 1100, its be can independent operating autonomous device.Fig. 8-10 shows exemplary apparatus 805,910 and 1010, and also can be with main configuration operation.
Data processor is integrated on the equipment can allows local control, supervision, processing and/or data storage, so that simplify the size using, reduce instrument, reduce cost, improve repeatability, reliability, performance, security, safety and quality control.In addition, can reduce the testing cost in many application, this application comprises the test point application, and wherein the cost of current test procedure, size and sophistication may be sizable.
Plate carries data processor can simplify user operation, for example by improved signal response is provided, as provides LED or output to replace chemistry to compare colour response.User operation also can or provide data to instrument by the form with the indication of functions of the equipments by automation mechanized operation partially or completely and be simplified.User's operation also can be simplified by allowing the storage data, and this allows the operation of user profile, improved robotization and simplification.
Plate carries size and the cost that data processor can reduce instrument.For example, the circuit on the use equipment allows function is integrated in the equipment, reduces the instrument demand thus, causes reducing of instrument size, and has eliminated the demand to instrument fully in some cases.In addition, the cost relevant with instrumentation with instrument cost can be reduced by the data processor that use has a function of simplification instruments design and automation mechanized operation.
Plate carries data processor can improve repeatability, for example, and by improving equipment quality control (QC), improve sensor and actuator performance and monitoring test condition and customer interaction.
Plate carries data processor can also improve performance.For example, use LOCAL FEEDBACK, control and Signal Regulation can improve sensor and/or actuator performance, and help to overcome interconnection problems by electromagnetic interference (EMI) and the magnetizability that increases signal response and minimizing parts.Plate carries calibration and proving program also can be realized to improve system responses by characterization sensor performance and/or adjustment sensor result.In addition, plate carries data processor can allow communication between each equipment, and this equipment is used for the data transmission between instrument and/or miscellaneous equipment.The use of the communication protocol between each equipment has improved correct signal transmission, and allows to transmit a plurality of values by single connection.This communication protocol can substitute relying on the needs by the conventional transmission of the independent raw sensor signal that connects, and it need be used for many circuits of a plurality of parameters, and is vulnerable to electromagnetic interference (EMI).The example of communication protocol including, but not limited to, RS232, I
2C, SPI, USB, ISO 14443, Ethernet, TCP/IP, GSM, GPRS and near-field communication.
Plate carries data processor can improve user security, for example under given conditions by the operating parameter of warning or change equipment is provided.This function allows to carry out QC and monitors.This supervision can relate to history or the present situation of equipment, follows the trail of (for example, Fabrication parameter), unit status, environmental aspect, processor use and pot-life including, but not limited to QC.For example, if if equipment no longer is in the operation tolerance limit, contaminated or exceeded operating conditions (for example, if no longer observe test protocol) at duration of test, QC monitors and can be used for the test of stopping using so.In addition, as making data, test condition, result and/or, can simplifying the tracking and the traceability of many application by keep record with equipment about the parameter storage of other related data of equipment.Data processor can be carried out the QC function on equipment and/or external instrument, with the demand of minimizing to external testing, and the reliability of raising equipment and test operation thereof.
Plate carries data processor can improve user security, for example, by restriction to the access of data, guarantee the authentication operation of equipment or external instrument and provide Product Safety to equipment manufacturers.For example, (for example, if correctly do not import data) or during the specific operation period (for example, before the key point in test procedure or during) under given conditions is to the visit of equipment or instrument or use and may be restricted.Can realize other security functions, as warning system, data verification, encryption and dongle protection.International Patent Application PCT/IB2006/003311 has described the exemplary products security functions that can realize.
Plate carries data processor and can allow firmware/software and the automatic slave unit of HardwareUpgring to install, and the equipment that makes is used as the upgrading source of external instrument.This upgrading typically is provided as new software version or the services package on the CD media, but because cost relevant with the frequent distribution of upgrading medium and the problem relevant with user installation do not provide (that is, only being used for main correction/upgrading) relatively continually.In addition, some install upgrading can the long-range execution via WWW, but only is connected to suitable network when instrument.
Thereby, provide device-dependent some or all of upgrade information to handle by automatic updating, eliminate the demand that the software that upgrades is installed from other medium, thereby simplify user's operation and reduce the total cost relevant with distribution with the production of upgrading medium.For example, traditional instrument specific hardware and some aspect of software can directly be incorporated on the equipment.Like this, can provide new equipment simply, it allows the function of upgrading and does not have and manual upgrading or replacement instrument hardware or relevant instrument shut-down, logistics difficulty and the cost of software.
The all purpose instrument method
Described communicator and data processor are incorporated in the complex interaction effect that can allow in the equipment between equipment and the instrument herein.In one embodiment, instrument can comprise that instruction module is to receive and to handle the instruction from the equipment that communicates with.This configuration permission equipment provides information about its function to instrument, for example comprises, and according to U.S. Patent number No.6,495,104 and the information of International Patent Application PCT/IB2006/003311.The application that allows " generally " or " general " instrument about the information of functions of the equipments is provided, and wherein a kind of instrument can be used for many application, and this equipment can provide application specific or indicate which data that will use on the instrument to instrument.
In one embodiment, instrument can comprise program coding carrying out its built-in function (moving as image data, control sensor and actuator, selection acquisition channel, pump, switch valve, design temperature), and program flow and GUI template.This equipment can provide data to allow by being that application-specific configurator stream and GUI template allow instrumentation.This method allows single instrument can carry out the analysis that is used for various application.When this method and careful system integration combination (, by carefully selective system parts between instrument and equipment, to separate (split)), can realize almost general instrument.For example, some or all of sensors, actuator, detection and/or control system can be positioned on the equipment, and electricity/light/physical interface commonly used can be provided on instrument.
In one embodiment, equipment not only comprises sensor, and also comprising provides the corresponding interface of feedback, control, signal Processing and/or calibration information electron device.On equipment, incorporate signal handling capacity into and can allow autonomy or half autonomous operation.This ability may be important for many fields and low-cost application, wherein the cost of traditional instrument and/or size restrictions their use.But described herein low-cost miniature instrument system can be as being connected with user or another instrument autonomous independent instrument of operating.They also can partly operate by communicating by letter with Other Instruments autonomously.Only as example, half autonomous device can deal with data and is operatively connected sensor and/or actuator on equipment, but receives order and the result is sent on the instrument that has connected.
The communicator parts
Be used to carry out the equipment 600 that partial analysis at least handles and preferably include communicator 605, with communicating by letter of convenient and equipment 600, as shown in Fig. 6 A.Communicator 605 can comprise at least one user interface or tool interface system, and communicator 605 can be suitable for following one or more users of being conveyed to: (a) equipment setting or operation information, (b) application message, (c) are about the information of partial analysis processing or (d) instruction.
In one embodiment, communicator 605 comprises user interface, and can with following one or more communication: (a) data processor 610, (b) instrument, (c) sensor or (d) actuator.The communicator 605 of equipment 600 can comprise display element to assist in operation.In this case, can use any suitable display element, for example, LCD, Organic Light Emitting Diode (OLED), LED and electroluminescence, fluorescence and incandescent display.In addition, but display element can comprise observed event, as permanent or impermanent change and electromagnetism, static, color, reflectivity and the fluid volume change etc. of heat.
In another embodiment, communicator 605 comprises tool interface system, is included in any appropriate interface between equipment 600 and the instrument.The example of appropriate interface mechanism comprise electrically contact, acoustics and ultrasonic vibration, machinery, magnetic, radio frequency, microwave and luminous energy.Communication between equipment and instrument or another equipment can comprise contact or contactless interface agency.
In another embodiment, equipment comprises the smart card electrode module, and it can for example communicate via contact or contactless interface.For example, Figure 12 A, 12E, 13A and 13E show exemplary apparatus 1200 and 1300, and it comprises chip card electrode module 1240 and 1350 respectively.
Illustrative embodiments describes in detail
According to optional aspect of the present invention, a kind of equipment that is used to carry out the processing of partial analysis at least comprises that plate carries data processor, comprises at least one integrated circuit components that is connected to one or more sensors or actuator component alternatively.(a) measures alternatively, (b) control at least a portion analyzing and processing, (c) allow to feed back to instrument or (d) comprise the Signal Regulation element by data processor for (respectively) sensor or actuator component.
Another optional aspect according to the present invention, a kind of equipment that is used to carry out the processing of partial analysis at least comprises that plate carries data processor, comprise electronics and/or integrated circuit, its can with from or main configuration operation, and fluid handling structure has usually, and one dimension still can be less than about 1 millimeter less than about 10 millimeters at least.Only as example, this fluid treatment interface can comprise crossing current band, passage, microchannel, pipeline, well, liquid reservoir and absorbing material.
In an illustrative embodiments, equipment according to the present invention comprises that plate carries data processor, and it comprises electronics and/or integrated circuit, is used for sensor and/or actuator are connected to one or more external units.For example, Fig. 7 shows the calcspar of system 700, but it comprises about instrument 710 with the consumer device 705 from configuration operation.But consumer device 705 comprises that plate carries data processing circuit, and it comprises storer 706, logic and numeral and/or mimic channel 707 and 708, and sensor and actuator component, and it is respectively the part of system 708 and 707.But the communicator (not shown) of consumer device 705 provides the interface with instrument 710, and this instrument 710 is carried out calculating, user interface and control and function for monitoring.
But but Figure 12 A-12E shows the composograph of consumer device 1200 of being made and being had the structure of the consumer device 705 that is similar to shown in Fig. 7 by multi-layer part.Figure 12 A shows top figure and interface layer 1205, and Figure 12 B shows electronic shell 1210, and Figure 12 C shows fluid layer 1215, and Figure 12 D shows bottom 1220, and the top view of Figure 12 E when showing all layers 1225 assembling.In this example, simulating signal and operation circuit 1230 are connected directly to sensor and the actuator 1235 on the equipment.Sensor and actuator 1235 are connected to chip card electrode 1240, and this chip card electrode 1240 is connected to instrument successively when communicating by letter with the smart card electrode module, can or can not have integrated circuit on this smart card electrode module.
In another illustrative embodiments, equipment according to the present invention comprises that plate carries data processor, and it comprises sensor and/or actuator are connected to the signal Processing that is connected with one or more external units and the electronics and/or the integrated circuit of control element.For example, Fig. 8-10 shows the calcspar of system 800,900 and 1000, but this system 800,900 and 1000 comprises and comprises the consumer device 805,905 and 1005 that plate carries data processor, except that control system and/or microprocessor 808,908 and 1008, but should consumer device 805,905 and 1005 also comprise detection part 806,906 and 1006 and processing controller 807,907 and 1007.But the communicator (not shown) of consumer device 805,905 and 1005 provides the interface with instrument 810,910 and 1010 respectively.
But but Figure 13 A-13E shows the composograph of consumer device 1300 of being made and being had the structure of the consumer device 805 that is similar to shown in Fig. 8 by multi-layer part.Figure 13 A shows top figure and interface layer 1305, and Figure 13 B shows electronic shell 1310, and Figure 13 C shows fluid layer 1315, and Figure 13 D shows bottom 1320, and the top view of Figure 13 E when showing all layers 1325 assembling.In this example, equipment 1300 is about providing external command (for example to control other electronic unit, logic, processor, controller and sensor or actuator system) external unit with from configuration mode operation, this other electronic unit can be provided on the equipment 1300.As shown in Figure 13 A, equipment 1300 can comprise user interface, and device comprises four buttons 1330.As shown in Figure 13 B, equipment 1300 can also comprise sensor 1335 and the data processor 1345 around fluid port 1340, and this data processor 1345 provides sensor feedback to instrument and chip card electronic module 1350.
In another illustrative embodiments, equipment according to the present invention comprises that plate carries data processor, and it comprises that electronics and/or integrated circuit are used for autonomous operation (that is, equipment is independent of Other Instruments and/or equipment operation).For example, but the consumer device 1100 shown in Figure 11 has plate and carries data processing circuit, it comprises all necessary detection systems 1105, processing controller 1110, data storage 1115, power supply 1120 and control system 1125 and user interface 1120, is used for autonomous operation.
But but Figure 14 A-14E shows the composograph of consumer device 1400 of being made and being had the structure of the consumer device 1100 that is similar to shown in Figure 11 by multi-layer part.Figure 14 A shows the interface layer 1405 of top figure and equipment 1400, and Figure 14 B shows electronic shell 1410, and Figure 14 C shows fluid layer 1415, and Figure 14 D shows bottom 1420, and the top view of Figure 14 E when showing all layers 1425 assembling.In this example, equipment 1400 comprises plate and carries microprocessor 1430, storer 1435, logical one 440, user interface 1445 and be connected to sensor and the simulating signal of actuator 1445 regulates 1450.
Figure 15 A-15E shows the circuit diagram of the equipment 1500 of the structure with the equipment of being similar to 1400.It will be understood by those skilled in the art that only to show specific features and specific features value for purposes of illustration, and can use other parts and/or other component values facilities and equipments 1500.Equipment 1500 may independent operating, and communicates by letter with miscellaneous equipment via communication interface 1510, shown in Figure 15 B.Equipment 1500 comprises that all necessary plates carry data processing circuit and are used for autonomous operation, comprise microprocessor 1530, storer 1535 and logical one 536, as shown in Figure 15 A, and connect 1550 to the Signal Regulation 1538 of sensor and actuator and the display that comprises OLED matrix 1540, shown in Figure 15 E.Equipment 1500 can be battery operation, shown in Figure 15 C, is used for operation or microprocessor 1530 is arranged to Reset and DASD 1535 so that power supply to be provided but external instrument can be connected to equipment 1500.But Figure 16 shows the composograph of the consumer device 1600 of the structure with the equipment of being similar to 1500, except the user interface of equipment 1600 has comprised light-emitting diode display 1605, has replaced OLED matrix 1540.
But Figure 17 shows the exemplary apparatus 1700 of the structure with the consumer device 1100 that is similar to shown in Figure 11.Equipment 1700 can comprise fluid handling component, as cross flow parts 1705 and shell 1710, has plate set sensor 1715 and/or circuit 1720 so that function to be provided.Only as example, can use conductive sensor to introduce in the equipment 1700 and the starting characteristics test timer at sample 1725 places that enter the mouth, and guarantee that sample suitably advances along the length and the width of test strip 1705 at the check point place or afterwards to detect sample.Equipment 1700 can also comprise indicator lamp 1730 or display, so that the information about test validity to be provided to the user, comprises that also communicator is with in miscellaneous equipment and/or instrument communication.Plate carries data processor can store out of Memory, as test result, time and date, identification, manufacturing and patient information, perhaps can limiting access or off-stream unit use preventing.Also can make and use up or other electric transducer carries the part of detection system as plate, with sensitivity and the reliability that increases this equipment.
According to a further aspect of the invention, rfid system can be in any suitable manner be used for various purposes with part of appliance is integrated, comprises the purpose except that identification.Only, can directly or by controller indirectly electrochemical sensor be connected to the RF transponder, be used for for purpose described herein data communication to external instrument or from the external instrument communication data as microprocessor as example.In an illustrative embodiments, the RFID parts can with the characteristic of internal sensor system communication with surveillance equipment or test.For example, but Figure 18 show and have the calcspar that plate carries the consumer device 1800 of data processing circuit, it comprises processor and the control module 1805 that is connected to sensor and/or actuator component 1810.Equipment 1800 has been incorporated RFID antenna 1815 into, and it can be used to communicate by letter and/or the providing of power supply 1820.
According to a further aspect of the invention, the equipment that is used to carry out the processing of partial analysis at least comprises that plate carries data processor, and it comprises that electronics and/or integrated circuit are to carry out various other functions, as agreement robotization, control and supervision; Visit and security control; The data processing of operation information, result, calibration information, manufacturing data, factory's setting, application message, equipment use, user's setting, sample data, time and date information, positional information, environmental surveillance and other quality control and quality assurance information.For example.International Patent Application PCT/IB2006/003311 has described exemplary electronic and/or integrated circuit, its carry out function be used for thus instrument upgrade information, service data or software configuration all or some can be included in equipment.
According to another optional aspect of the present invention, the equipment that is used to carry out the processing of partial analysis at least comprises communicator, and it comprises at least one user interface or tool interface system.
In certain embodiments, the equipment that is used to carry out the processing of partial analysis at least comprises communicator, it comprise remove complicated mutual ((for example as infrared or sound, order via speech recognition)) outside, allow the user interface of any suitable user interactions (pressing and/or reagent adds) as button.In the exemplary embodiment, equipment comprises user interface, and it has the element that can show operation information to the user, and described operation information is as the instruction of the proper operation sequence that is used for button and presses.This equipment can monitor internally that also the process of test is to guarantee validity.For example, equipment can monitoring key be pressed guaranteeing and is pressed the button or test parameters maintains in the specified limit with correct order.
But the consumer device 1300,1400 and 1600 shown in Figure 13 A, 14A and 16 comprises exemplary user interfaces.As described herein, the equipment 1300 of Figure 13 A comprises user interface, it comprises four buttons 1330, and record button is pressed and data are sent to another equipment is used for user's demonstration, and the equipment 1400 of Figure 14 A comprises user interface 1445, it comprises button and OLED graphic alphanumeric display, and the equipment 1600 of Figure 16 comprises user interface 1605, and it comprises that three three-color LED display devices are to instruct user and/or record button to press.Figure 19 A-19D shows the exemplary process stream 1900 of the application layer of the equipment 1400 shown in Figure 14 A-14E.Figure 20 shows the exemplary process stream of subroutine 2000, and its scanning is used for the keyboard of user's input.
In certain embodiments, the equipment that is used to carry out the processing of partial analysis at least comprises communicator, and it comprises the tool interface system that can be connected with instrument, and in some cases, provides instruction to instrument.In the exemplary embodiment, equipment can allow the process of instrument surveillance equipment operation.This feature for example helps to assist the automated system operation, and can for example help robotization user's current agreement and/or provide instruction to the user.
As described herein, can carry out partial analysis at least according to equipment of the present invention and handle,, handle, monitor and/or analyze as physics, chemistry and/or biological chemistry including, but not limited to data storage and test function.Supervision in equipment according to the present invention and system, control, collection, storage, manipulation and/or transmission data can be at duration of test and/or are taken place At All Other Times.
In one embodiment, according to of the present invention be used to carry out equipment that partial analysis at least handles can during the test run and outside monitor and/or control its environment and/or built-in function.Figure 21 shows the exemplary process stream 2100 of the equipment that is used to monitor its environmental baseline.In this example, if environmental baseline exceeds operational factor, can provide alarm so and/or can cause equipment to operate.
In another embodiment, the equipment that is used to carry out the processing of partial analysis at least according to the present invention can be carried out internal soundness control supervision to reduce the demand to external testing.For example, can monitor each equipment internally, and be stored in the result on the equipment and/or be sent to database.This supervision can be any adequate types, for example relates to Fabrication parameter, environmental baseline and the quality control of processor use and time etc. are followed the trail of.Figure 22 shows the exemplary process stream 2200 of equipment, if if be used for formerly using this equipment carried out test or reagent or sensor no longer in the tolerance limit of appointment, then the equipment that prevents is carried out test when starting.
In another embodiment, the equipment that is used to carry out the processing of partial analysis at least according to the present invention can be carried out security application.For example, can realize that electronics and/or integrated circuit are with limiting access or use equipment or relevant instrument under given conditions.In this case, if correctly do not import data, if do not provide correct fetcher code or user ID or during the specific run period (for example, before the key point in test procedure or during), then can limiting access.Equipment can be configured to carry out other security functions, as warning, data verification, data encryption and dongle defencive function etc.
In another embodiment, the equipment that is used to carry out the processing of partial analysis at least according to the present invention can change the operation of data, result, user interface or equipment under given conditions.For example, if the result does not use in the definite term, reads or alternately, can realize that so electronics and/or integrated circuit are to cause the result not readable.Figure 23 shows the exemplary process stream 2300 that is used for equipment, the time limit of surveillance equipment wherein, and when the time limit exceeds the pot-life of appointment off-stream unit.
In another embodiment, the equipment that is used to carry out the processing of partial analysis at least according to the present invention can be carried out telemonitoring and/or control.For example, can use equipment be used for the stage that the environmental surveillance at remote location prolongs.Under this situation, equipment can dispose has dried reagent battery, and it becomes activation when the water-soluble sample of primary element of battery is got in introducing wet, allow conduction and device activation thus.
In another embodiment, the equipment that is used to carry out the processing of partial analysis at least according to the present invention can be stored data on the single or multiple sampling period.This data can comprise test result, manufacturing, test, user and/or other data.For example, except that further feature, this data storage capacities can allow tracing equipment and historical and monitoring the time period that prolongs, and not with data transmission to external instrument.
In another embodiment, the equipment that is used to carry out the processing of partial analysis at least according to the present invention can operating part checking or calibration procedure.Equipment can for example provide calibration information and/or its internal electron, sensor and/or actuator system are carried out internal calibration.In one embodiment, the fixing known value (as ohmic load, voltage and/or current feedback circuit) that the instrument of connection can measuring equipment is as the part calibration procedure.In another embodiment, equipment can with about the data storage of the calibration of its plate set sensor in storer, be used for using by the instrument that connects.Alternatively, the instrument of connection can also be stored calibration information and/or equipment is carried out calibration.
In another embodiment, the network that the equipment formation part that is used to carry out the processing of partial analysis at least according to the present invention is distributed (for example, wired or wireless LAN, WAN, dedicated network, Intranet, the Internet etc.), and can carry out that medical science, industry and consumer's diagnosis, supervision and/or control are used etc.For example, Figure 24 shows the example networks 2400 of the equipment that is used to carry out the processing of partial analysis at least, and wherein equipment is communicated by letter on LAN/WAN.Figure 25 shows the example networks 2500 of the equipment that is used to carry out the processing of partial analysis at least, and wherein equipment is being communicated by letter on the Internet.Equipment can for example be connected to network via instrument in any suitable manner, perhaps is connected directly to network or network access point.In one embodiment, each equipment can independent operating, and mutual communication or communicate by letter with another point on the network.In another embodiment, equipment can move as the distributed instrument part, and wherein slave unit is remotely carried out some or all of controls and/or data processing.The advantage of this structure is the GUI that distributed, low-cost, high-performance sensors equipment can provide high-end data processing and be provided by the instrument of one or more networkings.In one embodiment, equipment comprises the plate set sensor.
In illustrative examples, can use equipment according to the present invention to handle to carry out partial analysis at least.For example, Figure 26 shows the processing stream of illustrative methods 2600, is used for using equipment according to the present invention to carry out partial analysis at least and handles.In step 2605, in sample introducing equipment.For example, sample can comprise that the material (as DNA) or the sample that have the biological content of extracting out from human body can comprise chemistry or biological specimen, are used for environment, industry, agricultural, gardening, food security, legal medical expert, animal doctor, medical science, bio-safety, materia medica, research, identification or other sample analysis and use.In step 2610, equipment operation is to carry out test to sample.For example, equipment can comprise the sensor of measuring the sample one side.In step 2615, the data that the data processor processes of equipment is relevant with test.For example, data processor can be stored or handle and test relevant data.In step 2620, the communicator facility of equipment is about the communication of test.For example, communicator can comprise the user interface with display element (as indicator lamp), and it indicates whether correctly to carry out test.Communicator can be convenient before carrying out test, during or convenient any time afterwards communication about test.
In whole instructions, (comprise claims), unless text needs in addition, speech " comprise (comprise) " and as the variant of " comprising (comprises) " and " comprising (comprising) " will be understood to mean integer (integer) or step or integer or the step group that comprises regulation, still do not get rid of any other integer or step or integer or step group.
The numeral of the quantity of the expression composition that uses in the instructions, composition, reaction conditions etc. will be interpreted as is in all cases modified by term " about ".
Though the wide region at the digital scope of this proposition and parameter, body matter is similar to the described digital value of accurate as far as possible indication.Yet any digital value comprises the certain errors that must obtain from the standard deviation of finding inherently their each measuring techniques.
In instructions, quote any prior art and be not and not will be understood that and be to recognize that or any type of hint prior art forms the part of common practise.
Though described the present invention, one of skill in the art will appreciate that and to carry out not special interpolation, deletion, modification and the replacement of describing, and do not break away from the spirit and scope of the present invention as defining in the claim with reference to its preferred embodiment.It is intended that and comprises all this modification and changes, as long as they fall in claimed the present invention or its equivalent scope.