CN101057142A - A single use, self-contained assay device for quantitative and qualitative measurements - Google Patents
A single use, self-contained assay device for quantitative and qualitative measurements Download PDFInfo
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- CN101057142A CN101057142A CN 200580038966 CN200580038966A CN101057142A CN 101057142 A CN101057142 A CN 101057142A CN 200580038966 CN200580038966 CN 200580038966 CN 200580038966 A CN200580038966 A CN 200580038966A CN 101057142 A CN101057142 A CN 101057142A
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- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/483—Physical analysis of biological material
- G01N33/487—Physical analysis of biological material of liquid biological material
- G01N33/48785—Electrical and electronic details of measuring devices for physical analysis of liquid biological material not specific to a particular test method, e.g. user interface or power supply
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Abstract
The invention describes a single-use, self-contained measuring device, comprising a data entry- and sampling part (303) including a sensor for measuring of physical or chemical property of a foreign substance and a data acquisition part (301) including electronic processing- and storage means, where the parts are integral parts of a packaging, formed of a sheet-like, printable and foldable material, the packaging being designed to enclose and protect the parts contained therein. The packaging may also include various instruments needed to perform a test.
Description
Technical field
The present invention relates to be used for sample is carried out quantitatively and the disposable self-contained assay device of observational measurement, measurement result is stored in the equipment, and can be collected and be used for long-range further analysis.
Background technology
The recent development of microelectronics and biochemical sensor technology produced considerable electronic equipment be used for keeping healthy autodiagnosis quantitatively and/or observational measurement, patient uses cheap diagnostic device that different body fluid is carried out basic quantitative measurment, thereby can be used for screening some possible diseases.Consider related expense, filtering out in the resident may be that a large amount of individual is normally unpractical for serious situation, also uneconomical.As a very tangible example, the growth of type ii diabetes mainly is in the Western countries, when having a strong impact on patient individual's quality of life, has brought huge burden to health care system.Different researchs think that western countries population on average has the people of a few percent may be in dangerous edge, can develop into the excessive risk of diabetes after having.If the adequate measures of taking, the early detection of diabetes can prevent morbidity or postpone morbidity at least.Yet because this is " a silent disease ", it is too late mostly to judge diabetes.There is not simple measure can make diabetes stop development in this stage.In this stage, oral or hypodermic injection insulin is only treatment, and this treatment is normally lifelong.In addition, in the several years, along with advancing of disease, other disease also can come one after another usually.
For being judged as the type ii diabetes patient who needs insulinize, constantly the monitor glucose level is correct so that guarantee insulin dosage.In hospital environment, glucose level can be very correctly in laboratory inspection by quantitatively.Yet this is unpractical for the daily absorption insulin of being in, because glucose level need be paid close attention to.Now, can see the quantitative measurment that has some instruments to be used for carrying out glucose level on market, these instruments generally include the sensor strip that electronic equipment and some singles use, and sensor strip is processed after use to be fallen.In order to obtain accurate reading, the calibration data of used sensor need be provided and need to carry out suitable temperature correction.Thereby this needs additional training and can introduce error source.
Yet in order to filter out a large amount of individuals effectively in a colony, illustrated method just has some practical problemss above adopting.Blood sample is delivered to centralab's facility needs special-purpose express service, because blood sample is considered to biohazard, therefore can not post usually.In addition, must follow very strict routine, so that the assurance sample is not lost or mixed up.Another possibility is that a large amount of individuals is called concentrated position, yet this also is uneconomic for the screening situation at all.Time also is a key factor, and some checks want seeking time very short from obtaining sample to execution analysis.
Commercially available electronic equipment as mentioned above may be a kind of optional scheme in theory, and still related logistics and capital investment are added and needed training can make this scheme implement little reality.
In addition, usually known to, so-called " fasting glucose check " is the most accurate because this check as morning first task carry out.Yet, in real hospital this to implement also be very unpractiaca.
The diagnosis and monitor other disease and/or medical science imbalance, such as blood cholesterol levels, hemochrome and infectious disease, also demonstrated similar practical problems.Except the blood sampling check, such as saliva, other biological sampling check of urine, ight soil, seminal fluid and sweat and so on all has tangible logistics and practical problems from diagnosis.
Approaching field is the field experiment chamber check in many application, the chemical analysis in factory, goes up earth analysis, the drinking water analysis.All these is at least one given characteristic of wanting analyzing samples, and check is carried out in the laboratory of concentrating usually.
In this screening, under the situation of the application-specific of field monitor and diagnosis, therefore wish to have a kind of use simple, can post to a large amount of individuals and the result can send the disposable self-contained assay device of being analyzed back to.
Disclose a kind of chemical examination and pen recorder in EP 0972196, wherein pen recorder can be pulled down from assay device.This equipment is made with the such durable material of reinforced plastic.Can be by perforated member or the recording-member of pulling down by lock bolt, latch, lock and so on.Assay component has the sample that is connected with pipeline liquid and applies reservoir, and reservoir or pipeline or both are contained the material of sample sampling and the ready indicator of check, thereby the user can determine when sample is suitably chemically examined.Removable parts contain and can carry out data communication and be fit to the storage recording of information equipment relevant with sample with assay component.
Another kind of disposable electric assay device has been described in EP 0722563.This disposable assay device has a card-like shell, has wherein held for the sample receptacle that obtains the signal relevant with the amount of analyte in the sample to become numerical check result's device with sample processing apparatus, with converting electrical signal and present the output unit of assay output.
A problem of prior art relates to the design of equipment, and this equipment produce and market is easily given the user, and the data of record can be collected by central location and further analyze.Allow the security filtering of cost efficiency and data to have very big advantage for application and the various areas that can carry out check.
The collateral security quality, the time of recording events and temperature regime may also be important during device processes.
Summary of the invention
The invention discloses a kind of disposable self-contained assay and diagnostic device; comprise data input and sampling section and part of data acquisition; input of described data and sampling section comprise and are used for measuring the physics of foreign matter or the sensor of chemical attribute; described part of data acquisition comprises electronic processing and memory storage; these two parts are the parts that are integrated into one that can be printed the packing that forms with Foldable material by sheet, the part that described packing is designed to surround and protects wherein to be comprised.Described packing can also be held the required various apparatuses of execution check.
From conveniently, desirable is that sample is packaged into a bag, and the device that all are essential is kept in a whole set of packing together, and described packing serves many purposes.
This equipment can be assembled into even shape, and is folded into an a whole set of packing.This has simplified manufacture process considerably.
After packing can further be designed such that and carry out measure, for the unwanted packaged unit of the data of preserving collection can be processed falls.In addition, because sensor is subjected to the pollution of chemistry and/or biological substance, also wishes this part is pulled down and dispose.By package design one-tenth is had a part of holding data processing and memory storage, the remainder of packing can be torn after measurement is finished and dispose.So can preserve for further analysis with preserving section data.If be equipped with the contactless communication interface, then can with the host computer system automatic exchange message.
Typical biology sensor is electrification (oxidation-reduction type) thermodynamic system that depends on current potential or current-responsive relation or their combination.The sensor response is very relevant with temperature usually.Therefore, one aspect of the present invention provides the temperature sensing device of the temperature deviation of the response that can compensate record.In addition, can the serviceability temperature sensor to User Alarms: temperature is too high or too low and can not carry out accurate measurement.
In addition, owing to freezing and/or fusing may make the result who obtains from biology sensor invalid, the existence of temperature sensor can also be used to guaranteeing that assay device is storing and also do not suffering temperature extremes between the delivery period.
According to the sensor chemistry, may need to add and measure so that monitor humidity, because humidity can influence the reliability of reading.So can add drying agent or humidity sensor so that the change of compensation humidity if perhaps humidity effect is excessive, is notified disarmed state.
Though described embodiment has introduced the diagnostic device of quantitative measurment blood sugar in diabetes are screened, same basic equipment can be used for other diagnostic application.In healthcare applications, sample is often taken from blood, saliva, urine, sweat, mucus, fester, wound liquid, seminal fluid or ight soil, and all these is to make us uncomfortable, from logistics may be harmful to reluctant.Dismountable design has been arranged, and contaminated part can irreversibly partly be pulled down from Data-carrying, thereby has solved this problem.
From audit, had with the incident of all records and data point add timestamp and with the audit check of unique identification pairing, can strengthen the degree of confidence of the data of collecting and finally obtain more reliable result.By using data processing equipment to add digital signature to result, can further strengthen the integrality of data, when data when assay device sends to remote data base, can examine so that guarantee their authenticity digital signature.
In some applications, before the memory check result, may need to collect additional information.By an integrated electronics inquiry table, for example such as at US 6,628, described in 199, can the slave unit user collect subjectivity or out of Memory, and the objective data after conversion is stored in the electrical form.
In addition, in some applications, the problem that also has the legal of sample and/or approve just has notice or the trained talent allows the execution check, perhaps has the worry of check by others' execution outside the individual who is scheduled to.This check can comprise the illegal material that monitors or detect discovery in blood and/or urine check, and these materials can be arcotic or hallucinogen matter.This design with the whole series packing of integrated microprocessor and memory storage also allows an integrated keypad in packing, can realize User Recognition and proof scheme, before carrying out check, notify predetermined individual with password or identification code by another channel outside the used channel of sale equipment itself.By such input is imported as PIN, it can replace signature to use by the people who carries out check.
Yet assay device can be designed to have minimum integration of user interaction functionality usually,, it is contemplated that therefore that some is used except sensor itself at all without any input media so that try one's best the minimizing expense.On the other hand, can increase and user interactions and synchronous one group of attachment device, sound components and additional visual detector that expection is moved.If check is used for non-clinical setting, then can have on some sheets and diagnose, provide signal such as the test findings of " positive " or " feminine gender ".Typical audible indicator is a piezoelectric speaker, and typical visual detector can be light emitting diode (LED) or print electric chromium ink.
Yet, it is apparent that application is not limited to the self diagnosis in the health care facility.By utilizing " sample packages " of the sampling website that can send to hope simply, deconditioned personnel just can carry out biochemical analysis to potable water, production piece, pedotheque, food, beverage etc.When having inspected, the data carrier of tearing is contained in and returns the inspection center in the self-addressed stamped envelope of pre-printed and pre-post-pay paystation and be used for subsequent analysis.
Description of drawings
In the accompanying drawing of this instructions:
Fig. 1 shows an assay device that assembles;
Fig. 2 shows the assay device of having opened;
Fig. 3 shows the data carrier of the pulling down part and the Sensor section of assay device;
Fig. 4 shows the exploded view of packaged unit;
Fig. 5 shows printing and stacked section; And
Fig. 6 shows the section of the electronic module of installation.
Embodiment
Fig. 1 shows the assay device before the delivery.It is a whole set of that equipment and package design thereof become, and all parts are by packaging protecting.Otch (101) allows equipment to be added the demonstration of typical shop with informedness literal (103).Comprise the recess of tearing before use (102).
Fig. 2 shows assay device before use.Equipment and packing thereof are opened by tearing recess (102 among Fig. 1).The user can see one group of inquiry surface plate (201) and sample area (203) of having the button (202) of protrusion.Also comprise and carrying out or other required article of preparation sample,, preferably be bonded at the packing inboard by contact adhesive such as lancet and wiper blade (204).
Fig. 3 shows the situation of assay device after finishing sampling.Part of data acquisition (301) is separated with data input and sampling part (303), data input and sampling part (303) can be disposed with auxiliary article (204) as the normal domestic use waste product.Because sample area by for example blood contamination, therefore can be included in and lose preceding optional feature with data input and sampling part sealing, such as sticking line when having inspected.So recorded data sends back to the center of carrying out data retrieval.Part of data acquisition (301) can send by surface mail, and provides printed in advance address field (302) so that it can be dropped into mailbox.
Fig. 4 shows described assay device with the decomposition view of simplifying.Described equipment comprise by egative film (401) and top flat (409) form laminated.Described equipment comprises two parts (301,303) of being separated by hinged recessed district (414) and cutout regions (413), so that these two parts are easy to separate by tearing.Part of data acquisition (301) comprises the power supply (411) that has electronic chip (404), battery forms and the electronic module (403) of coupling arrangement (412), and described coupling arrangement has corresponding printing tie point on printed sheet (401).Use electroconductive binder electronic installation to be connected to the egative film (401) that has its printed antenna sheet (402).Recording section (409) comprises the button (406) and the sensor (418) of protrusion, and they all use conductive trace (405,417) to be connected to electronic module (403).Button (406) is formed by the printed switches point in the Printing Zone on egative film and the top flat (407), and the mechanical force that is applied on the button (406) is set up electrical connection between pad (407).Sensor (418) is printed with the enzyme material, connects trace (417) and plays the electrode effect.Sensor (418) is exposed to the user by the otch (not shown) on the top layer (409).
Electronic chip can be an ASIC who comprises following function:
The microprocessor that runs application
The non-volatile data memory of canned data
Incident and the data real-time clock that provides objective timestamp to storage
Permission is with the unique identifier of producer's programming of the record linkage in unique equipment and the database
Carry out temperature compensation and store and transmit the built-in temperature sensor of temperature monitoring in data acquisition period
To carry out the device of signal adjustment and analog-to-digital conversion from the sample data of sensor
The radio telemetry communication interface that permission equipment is read by wrappage, preferably can with existing radio-frequency (RF) identification (RFID) operating such such as ISO 15693, or such as at application US6, the cheap substitute of the capacitive system of describing in 615,023
Slave unit being sent and send to the information of equipment can be encrypted and/or with the codon system of password signature.
For the ease of producing, equipment is divided into two parts manufacturing.Just become final products after this two parts assembling.
Part 1 has electronic module (403), and wherein ASIC (404), battery (411) and supporter are assembled on the thin polymer film mylar of etch copper (for example with).Described film has some and is stretched over thin space lead on the large bonding pad (412), and described pad can be received on the substrate with big spacing lead.ASIC is installed on the film with the post raised pad or by traditional being soldered on the metal.
Part 2 is virtual package.The well-known method and apparatus manufacturing of industry of described packing.The cardboard that scribbles polymeric layer is printed on conductive ink traces (417,405), and these traces form " disposable circuit board ", and polymer coating is used for making the humidity effect minimum in the high-sensitivity measurement.As required, have found that carbon-graphite or silver-colored conductive ink can provide good performance.These traces are connected to conductive welding disk matrix (412) so that be connected to electronic module (403) with the pressure-sensitive key (406) of sensor (418) and printing.Then, use overprinting figure (103), cutting, embossing and bending with present process.As at application US 6,628, described in 199,, form the pressure-sensitive key of barrier film (406) by the stacked barrier film of making again by the conductive ink pool being applied on the leading flank of the cardboard that scribbles polymkeric substance.Preferably, contactless communication is used antenna (402,410) also is printed on the polymer coating.As last step, add upper sensor (418) with the thick film screen printing of Sensorised compound, wherein the conductive ink of Miao Shuing (417) also forms sensor electrode.Perhaps, also can be that sensor is added as third party's parts of finishing.Such sensor is normally paid as the bar that has connection electrode.In such arrangement, electroconductive binder is printed onto on the interior conductor wire of packing.
Be applied to the position of printed conductor pad (412) on the paper substrate of part 2 by the part 1 that will have electronic module with electroconductive binder, equipment is assembled.Then, product is folded, use the heat-activated adhesive of printing or injection to be sealed.
Fig. 5 shows the section of conductive trace (405,417).Described equipment comprise by top flat (401) and egative film (409) form laminated, each covers top flat and egative film with moisture resistant polymers layer (502,505).Egative film is printed on the conductive ink (402,405,417) of flat shape.By forming the laminated of completion with heat activated bonding agent double exposure top flat, egative film and conductive trace (401/502 and 409,505,405), heat activated bonding agent forms uniform tack coat (506) after the folded step of heat.
Fig. 6 shows the section that cuts along the line a-a among Fig. 4, and wherein electronic module (403) adheres on the printed sheet (409).Printed sheet is printed on conductive ink (402,405,417).Step in the end, with electroconductive binder (506) double exposure to the top of printed sheet.The electronic module (403) that comprises lithium battery (411) and electronic chip (404) is applied on the fexible film (403), and film (403) is applied on the bottom (401) again.In the folded step of heat subsequently, upper strata (409) and bottom (401) also are used for forming respectively electrically contacting between the conductive trace (405) of electric conductor on the film (601,602) and printing and the antenna sheet (402) with the mechanical bond that is formed by bonding agent (506) the described bonding agent that links together.
Before using, electronic module need be by time and the optionally sensor calibration data initialization from the precise time source.In addition, according to sensor type and chemical attribute, may need a reference voltage calibration steps.For conserve battery power, the power consumption of ASIC is low-down when being not activated.After initialization clock and calibration data, product is just available at any time.Necessary battery capacity should be calculated by the time from being issued to use of expection.On the other hand, this time is subjected to the restriction of the pot-life of Sensorised compound usually.Some sensor even may be when storing to low and/or high environment temperature sensitivity.By using the temperature sensor in the ASIC, just can the watch-keeping environment temperature.If surpass the temperature extremes of sensor, will show that equipment can not provide expected results to User Alarms.Perhaps, if sensor has known temperature and/or aging profile, when changing, situation can carry out suitable adjustment and recalibration.
The equipment operating position can be described below:
1. chemical examination/diagnostic device wraps in and contains the concentrated manufacturing site location assembling of carrying out all required indispensables of desirable check and information.
2. equipment is delivered by the normal mail service and is given patient.Packing is designed to stand change in transportation and possible normal infraction of regulations and the humidity of memory period.In order to cut the waste and material usage as far as possible, packing is made into the integral part of diagnostic device.
3. the user staves by the recessed area (102) with the packages sealed design and opens the packing of sealing.When opening, integrated electronic equipment detects packing and opens, and mode of operation is switched to " effectively ".Timestamp is stored in the storer of electronic module, to keep when tearing the record of packaging seal, when opening the finished product bag, equipment is carried out self check, and it is intact and transporting and the memory period temperature never goes beyond the limit of to examine this bag.
4. the measuring operation in order to wish synchronously clearly, the user is imprinted on start button in the wrappage by belling.When described start button is pressed, timestamp is stored in the storer of electronic module.From practicality, the inside of bag is printed on indication how to carry out check.So, can put at " startup " button place " you read and understood how to carry out the indication of check after, push this key ".
5. alerting signal and/or visual detector prompting user answers the limited several problems (201) relevant with the measurement that will carry out.Go up the execution input at the button (202) of protruding seal, these are answered in timestamp writes down and be stored in the storer of electronic module.
6. different alerting signals and/or visual detector prompting user make blood sample be exposed to sensor (203,418).The obvious change of physical attribute signal when having sample on electronic module watch-keeping sensor and the sensor.With sensor chemistry attribute, electronic module is carried out actual sampling in one period schedule time per sample.The user packs the cleaning that contains sterile lancets and sterilization and wipes away sheet for convenience.
7. when sampling is finished, notify user's measurement to finish.
8., then described information is write writing on the notepaper on the data carrier part if the user of equipment has additional suggestion or informational needs is sent to data carrier analysis place.For fear of all data carriers manually being read or additional optical scanning and when obtain the objective timestamp of writing information, write notepaper and make with pressure sensitive.Do the time spent writing the pressure that notepaper is subjected to pen, this is got off by data processing and memory means record and adds timestamp.
9. then, the user tears or cuts packing along the clear recessed district (413) that marks of packing, thereby the data that have storage and the part of data acquisition of big envelope are separated with the other parts (303) that no longer need to gather with the conversion sample.
10. the equipment user disposes with household waste and comprises using and present part (303) useless of contaminated sensor.The part of property use this time is designed to can be with the lancet of crossing with wipe away sheet and leave in and lose after the inside folds sealing.
11. " data carrier " has paid postmark and be printed on the return address (302) of a side, the user sends centralized data scanning facility with it as surface mail.
12. at centralized data scanning facility place, read " data carrier " partly (301), give centralized data base with result transmission with the RFID scanner.Remote RF ID technology has the anti-collision performance, can high-velocity scanning mass data carrier, even they are to be contained in the mailbag.
13. when data enter centralized data base, data are decrypted and examine digital signature based on the application of server.Then, may need data are carried out other processing, so that be converted to useful consequence.
14. if imported additional information as top illustrated in the step 6, then autoscan detects to write and has information on the notepaper.So having the data carrier of this information need manually read with data and import.
Though above operating position has just been introduced the record and the conversion of single sample, an equipment obviously can be configured to have a plurality of sensor site, so that can carry out check several times in one long period.In addition, according to examination requirements, monitor that simultaneously more than one foreign matter may be useful.In this case, can in the plane of sealing, closely dispose several sensors mutually, make sample be distributed to equably on all each sensors.
Claims (31)
1. disposable a whole set of measuring equipment; described equipment comprises data input and sampling section (303) and part of data acquisition (301); described data input and sampling section comprise the sensor (418) that is used to measure the exotic qualitative attribution; described part of data acquisition comprises that electricity is in handling and memory storage; it is characterized in that; described data input and sampling section and part of data acquisition are the integrated parts of a packing; described packing can be printed with Foldable material by sheet and be formed, the described part that described packing is designed to surround and protects wherein to be comprised
2. according to the described equipment of claim 1, it is characterized in that, described Foldable material comprise one laminated, described laminated egative film (401) and the top flat (409) of comprising, the electronic module (403) that is applied on the fexible film (605) is fixed to egative film (401), and conductive trace is printed on the egative film (401), and described egative film and top flat bond together mutually by conductive adhesive (506).
3. according to claim 1 or 2 described equipment, it is characterized in that described sensor (418) is printed on egative film (401) and upward and with the conductive trace that is connected to electronic module (403) (417) is connected
4. according to claim 1 or 2 described equipment, it is characterized in that described sensor (418) is attached on the egative film (401) by conductive adhesive.
5. according to claim 3 or 4 described equipment, it is characterized in that described equipment comprises a plurality of sensors, gather, perhaps carry out several and measurement single acquisition so that allow in more than one individual event, to carry out several times.
6. according to claim 2,3,4 or 5 described equipment, it is characterized in that described egative film and top flat (401,409) are coated with moisture barrier (502,505).
7. according to claim 1,2,3,4 or 6 described equipment, it is characterized in that described part of data acquisition (301) can be pulled down from data input and sampling section (303).
8. according to the described equipment of claim 7, it is characterized in that each removable lower part can be identified after being removed from the part of distinct device so that allow by uniquely tagged.
9. according to the described equipment of claim 1, it is characterized in that described packing can contain to carry out measures required overage (204).
10. according to the described equipment of above any one claim, it is characterized in that, described part of data acquisition comprises an electronic module (403), described electronic module (403) comprises electronic chip (404), power supply (411) and is used for the data communication equipment (DCE) (402 of swap data, 410), described chip has data collector, data processing equipment, nonvolatile data storage and time holding device, and described time holding device is used for adding timestamp to the data that are stored in the generation in the data storage device.
11. according to the described equipment of claim 10, it is characterized in that, described electronic module (403) comprises the tie point (412) that is connected to corresponding printing coupling arrangement, is used for electronic module is connected with the conductive trace (417) of sensor (418) on being connected to data inputs and sampling section (401).
Near 12., it is characterized in that described electronic chip (404) has temperature measuring equipment according to claim 10 or 11 described equipment, so that the temperature the quantization sensing device (418).
13., it is characterized in that described temperature measuring equipment is provided at the quantitative values of ambient temperature value when gathering according to the described equipment of claim 12, and described temperature value is used as operand in the temperature dependency process of conversion measurement result.
14., it is characterized in that described temperature measuring equipment is used for monitoring from producing to the permissive temperature limit that whether has surpassed equipment in cycle equipment life of finishing the point when gathering according to claim 12 or 13 described equipment.
15. according to the described equipment of claim 10, wherein said time holding device is from centralized time source initialization, and described time holding device is maintained to the point of gathering when finishing by power supply (411), after this is cut off with economize on electricity.
16. according to the described equipment of claim 10, it is characterized in that, but described electronic module comprises with the equipment user and carries out mutual device for tone frequencies or optical visible device.
17. according to the described equipment of claim 16, wherein said optical visible device is to use electric chromium ink to be printed on shape on the backsheet surface.
18., it is characterized in that described equipment comprises the drying agent compartment according to the described equipment of claim 10, be used for eliminating the moisture of the reliability that can influence sensor measurement.
19., it is characterized in that whether depleted described drying agent comprise the device that is monitored and provided the ability of drying agent signal by data processing and memory storage according to the described equipment of claim 18.
20. the described equipment of any one claim according among the claim 10-19 is characterized in that, described data communication equipment (DCE) is used at data processing equipment and receives swap data between the external host of data.
21., it is characterized in that described electronic chip is furnished with unalterable electronic mark according to the described equipment of claim 20, be used for identifying uniquely described equipment.
22. according to the described equipment of claim 21, it is characterized in that, encryption processing apparatus and at least one key are stored in the described data storage device, and described encryption processing apparatus is used for carrying out and encrypting, decipher, produce digital signature and examine in the operation of digital signature at least one being stored in data in the data storage device.
23. according to the described equipment of above any one claim, it is characterized in that, described packing has at least one and goes up the anti-tamper strip of paper used for sealing that extends in zone (102), such as circuitry lines, described strip of paper used for sealing must be isolated inevitably so that use described equipment according to predetermined usage, and isolating by described data processing and memory storage of described strip of paper used for sealing detected.
24., it is characterized in that described packing comprises an extention according to the described equipment of above any one claim, described extention has the inquiry surface plate (201) that allows the equipment user to provide additional annotations.
25., it is characterized in that described inquiry surface plate (201) comprises the protruding seal button (202) of inquiry table easy to use according to the described equipment of claim 24.
26., it is characterized in that described inquiry surface plate comprises input media according to claim 24 or 25 described equipment, whether carried out collection so that examine the predesignated subscriber.
27., it is characterized in that described input media comprises the numeric keypad of accepting personal identification number (PIN) according to claim 24,25 or 26 described equipment.
28. according to claim 25,26 or 27 described equipment, it is characterized in that, described button (202) is formed by a pair of conductive switch point (407) and the zone of the printing conductive on the top flat that is printed on the egative film (401), thereby the mechanical force that is applied on the button is set up electrical connection between switching point (407).
29., it is characterized in that described extention with inquiry surface plate is the part of data input and sampling section according to the described equipment of claim 24.
30. according to the described equipment of above any one claim, it is characterized in that, described part of data acquisition (301) is the card form with pre-printed address field (302), allowing this part after data inputs and sampling section are pulled down, can posted or collect, and do not need equipment user's adjunctive behavior.
31. a manufacturing is according to the method for the described disposable a whole set of measuring equipment of above any one claim, it is characterized in that, to have electronic chip (404), the electronic module (403) of power supply (411) and supporting assembly is installed on the thin polymer film, with conductive ink traces (417,405) and conductive welding disk (412) matrix printing on the packing that comprises the cardboard sheet that scribbles polymkeric substance, the sensor (418) that is applied on the cardboard sheet is connected to printed traces (405), and the antenna (402 that will be used for contactless communication, 410) be printed onto on the cardboard, after this, by using electroconductive binder will comprise that printed conductor pad matrix (412) position that the thin polymer film of electronic module installs on the sheet assembles described equipment, and fold packing of formation, and seal by the heat-activated adhesive that uses printing or spray.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US52252904P | 2004-10-11 | 2004-10-11 | |
| US60/522,529 | 2004-10-11 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN101057142A true CN101057142A (en) | 2007-10-17 |
Family
ID=35744637
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200580038966 Pending CN101057142A (en) | 2004-10-11 | 2005-10-06 | A single use, self-contained assay device for quantitative and qualitative measurements |
Country Status (4)
| Country | Link |
|---|---|
| EP (1) | EP1800121A1 (en) |
| JP (1) | JP5074193B2 (en) |
| CN (1) | CN101057142A (en) |
| WO (1) | WO2006040106A1 (en) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103519827A (en) * | 2012-06-28 | 2014-01-22 | 霍夫曼-拉罗奇有限公司 | Device for monitoring at least one body function of a user and method for manufacturing the same |
| CN104067298A (en) * | 2012-01-30 | 2014-09-24 | 大日本印刷株式会社 | Information gathering device |
| CN113503900A (en) * | 2021-07-14 | 2021-10-15 | 苏州大学 | Method for manufacturing three-dimensional sensor and sensor |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP4519757B2 (en) * | 2005-11-07 | 2010-08-04 | シャープ株式会社 | Analysis board and analyzer |
| KR101407433B1 (en) * | 2006-05-09 | 2014-06-17 | 코닌클리케 필립스 엔.브이. | Assay device |
| CN101466301B (en) * | 2006-06-12 | 2012-02-15 | 皇家飞利浦电子股份有限公司 | Body monitoring device, body data acquiring method and method of determining the presence, location and/or stage of a wound |
| WO2008007280A2 (en) * | 2006-06-28 | 2008-01-17 | Koninklijke Philips Electronics N.V. | Assay system and method |
| CN101479040B (en) * | 2006-06-28 | 2012-06-13 | 皇家飞利浦电子股份有限公司 | Disposable assay device with removable modules and remote data transfer system |
| EP2111209B1 (en) * | 2007-01-22 | 2022-05-04 | OraSure Technologies, Inc. | Container and method for supporting home testing and diagnosis of infectious diseases |
| US20090188811A1 (en) * | 2007-11-28 | 2009-07-30 | Edwards Lifesciences Corporation | Preparation and maintenance of sensors |
| DE102008052693A1 (en) | 2008-10-22 | 2010-04-29 | Sartorius Stedim Biotech Gmbh | Container with computer product |
| US8394246B2 (en) | 2009-02-23 | 2013-03-12 | Roche Diagnostics Operations, Inc. | System and method for the electrochemical measurement of an analyte employing a remote sensor |
| KR20130039717A (en) * | 2010-03-22 | 2013-04-22 | 임팩 헬스, 엘엘씨 | Self contained in-vitro diagnostic device |
| JP5842327B2 (en) * | 2010-12-07 | 2016-01-13 | 大日本印刷株式会社 | Portable information transmitting apparatus and substance information management system including the same |
| JP6079833B2 (en) * | 2015-07-28 | 2017-02-15 | 大日本印刷株式会社 | Portable information transmitting apparatus and substance information management system including the same |
| JP6753058B2 (en) * | 2015-12-21 | 2020-09-09 | 大日本印刷株式会社 | Paper substrate for conductive circuit, paper substrate with conductive circuit, and sheet-shaped information recording device |
| EP3567648A4 (en) | 2017-01-05 | 2020-08-26 | Maxell Holdings, Ltd. | Wearable patch, and sheet-shaped cell |
| JP6681054B2 (en) * | 2017-01-23 | 2020-04-15 | 大日本印刷株式会社 | Information gathering device |
| JP7108968B2 (en) * | 2018-03-13 | 2022-07-29 | 大日本印刷株式会社 | Information gathering device |
| JP7091980B2 (en) * | 2018-09-28 | 2022-06-28 | 大日本印刷株式会社 | Information recording device |
Family Cites Families (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS6361157A (en) * | 1986-09-02 | 1988-03-17 | Tosoh Corp | Chemical sensor card |
| JPH0416239Y2 (en) * | 1987-04-25 | 1992-04-10 | ||
| GB9705667D0 (en) * | 1997-03-19 | 1997-05-07 | Jackson James R | Diagnostic and analytical devices |
| US20020180605A1 (en) * | 1997-11-11 | 2002-12-05 | Ozguz Volkan H. | Wearable biomonitor with flexible thinned integrated circuit |
| US6602469B1 (en) * | 1998-11-09 | 2003-08-05 | Lifestream Technologies, Inc. | Health monitoring and diagnostic device and network-based health assessment and medical records maintenance system |
| GB9825992D0 (en) * | 1998-11-28 | 1999-01-20 | Moorlodge Biotech Ventures Lim | Electrochemical sensor |
-
2005
- 2005-10-06 EP EP05791059A patent/EP1800121A1/en not_active Withdrawn
- 2005-10-06 JP JP2007536060A patent/JP5074193B2/en not_active Expired - Fee Related
- 2005-10-06 WO PCT/EP2005/010879 patent/WO2006040106A1/en active Application Filing
- 2005-10-06 CN CN 200580038966 patent/CN101057142A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104067298A (en) * | 2012-01-30 | 2014-09-24 | 大日本印刷株式会社 | Information gathering device |
| CN104067298B (en) * | 2012-01-30 | 2017-06-13 | 大日本印刷株式会社 | Information collection apparatus |
| CN103519827A (en) * | 2012-06-28 | 2014-01-22 | 霍夫曼-拉罗奇有限公司 | Device for monitoring at least one body function of a user and method for manufacturing the same |
| CN113503900A (en) * | 2021-07-14 | 2021-10-15 | 苏州大学 | Method for manufacturing three-dimensional sensor and sensor |
Also Published As
| Publication number | Publication date |
|---|---|
| JP2008516248A (en) | 2008-05-15 |
| EP1800121A1 (en) | 2007-06-27 |
| JP5074193B2 (en) | 2012-11-14 |
| WO2006040106A1 (en) | 2006-04-20 |
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| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
| WD01 | Invention patent application deemed withdrawn after publication |
Open date: 20071017 |