Background technology
Along with the progress of medical science and the modern lifting day by day for health care idea, fixed point is looked after detection (Point-of-Care; POCT) market universalness also increases.The self-checking product that the detection trend of this class is fast, cheap, volume is little and do not need professional to operate, such as blood glucose meter, style electronic ear temperature gun and electronic sphygmomanometer etc.And in this field, the use of test strip has been a very skillful technology, wherein again to analyze being most widely used of blood sugar.
In known biochemical sensing system, every a collection of test strip has all been set unique Mutation parameter or identification code in process of production.Therefore,, using measuring equipment to need, by cipher card (code card), measuring equipment is carried out to identification or correction before this batch of test strip measured, as United States Patent (USP) the 5th, 366, No. 609 and No. WO00/33072 institute of PCT patent disclose.Yet the burning of cipher card and preparation can increase manpower and manufacturing cost, and often there is user and forget and insert or wrong plug cipher card causes the problems such as mistake on error recovery and data interpretation or cipher card loss.
In order to improve cipher card, use the inconvenience causing, United States Patent (USP) the 6th, has disclosed a kind of bar code (bar code) of utilizing for 814, No. 844 as the test piece of identification mode.United States Patent (USP) the 6th, utilizes for 814, No. 844 the bombardment of high energy pulse laser light to be coated on the surface of the gold target material on substrate, makes golden target material surface flash evapn, and forms bar code graphics.For example, yet the detection system that the identification mode of this bar code is optical profile type, needs to use extra optical element, use CCD or LED to detect, so manufacturing cost is higher.Moreover the repeatability of this kind of identification bar code and accuracy, in target material surface material, not only can cause technologic restriction also may increase manufacturing cost.
In addition, TaiWan, China M304662 new patent has disclosed another kind of biochemical sensing system of exempting from cipher card, it arranges some buttons at pick-up unit, in order to input predetermined English alphabet or numeral, this predetermined English alphabet or figure denote in the packing of test strip (outer box, glue box, instructions ... etc.) upper, and the inner default one group of parameter of corresponding pick-up unit.After input this predetermined English alphabet or numeral, its corresponding parameter will be sent to microprocessor in pick-up unit pick-up unit is set to correction, and reaches the object of accurate test.
No. 97208206 patent application case of TaiWan, China also disclosed a kind of test piece of exempting from cipher card, and its one end in test piece arranges a plurality of composed components, and the composed component of part is punched and forms 0 or 1 electric connection, to be combined into multiple figure code.Yet, this detection system has multiple restriction, as drilling technology needs each sensing terminals of high precision, measuring equipment and the contraposition between each composed component, need high accurancy and precision etc., and because the figure code in test piece is as dentation, when inserting measuring equipment, also have the risk of fracture.
Therefore, be necessary to provide a kind of biochemical sensing system of exempting identification or the correction of cipher card and thering is property easy to detect.
Accompanying drawing explanation
Fig. 1 illustrates the test strip of the embodiment of the present invention;
Fig. 2 illustrates the STRUCTURE DECOMPOSITION figure of the test strip of Fig. 1;
Fig. 3 and Fig. 4 test strip for illustrating according to different embodiments of the invention;
Fig. 5 A and Fig. 5 B illustrate respectively the different embodiment of the test strip with sensing function; And
The block schematic diagram that Fig. 6 is the biochemical sensing system that illustrates according to the embodiment of the present invention.
Description of reference numerals
100 test strips
110 insulated substrates
120 conductive layers
122 electrode groups
123 working electrodes
124 reference electrodes
127 identification units
128 composed component groups
128a, 128b, 128c, 128d, 128e composed component
129 link component groups
129a, 129b link component
130 insulating mats are high-rise
132 reaction zones
132a opening
140 reactions
150 upper covers
153 air holes
300 test strips
310 insulated substrates
323 working electrodes
324 reference electrodes
325 sensing electrodes
326 detecting units
327 identification units
328 composed component groups
328a, 328b, 328c, 328d, 328e composed component
329 link component groups
329a, 329b link component
332 reaction zones
400 test strips
410 insulated substrates
423 working electrodes
424 reference electrodes
426 detecting units
427 identification units
428a, 428b, 428c composed component
429a, 429b link component
432 reaction zones
500a, 500b test strip
524a, 524b reference electrode
527a, 527b identification unit
600 biochemical sensing systems
630 measuring equipments
640 connectors
650 microprocessing units
655 numerical datas
660 displays
670 power supplys
H, h1, h2, h3 through hole
P1, P2 hole
S1, S2 check point
Embodiment
The present invention discloses and does not a kind ofly need to utilize cipher card can carry out biochemical sensing system, measuring equipment and the test strip of identification or correction, its can exempt cipher card technique, easy to operate, prevent the possibility forgetting errors such as inserting cipher card or wrong plug cipher card and can reduce error generation in use procedure.In order to make narration of the present invention more detailed and complete, can and coordinate the accompanying drawing of Fig. 1 to Fig. 6 with reference to following description, wherein similarly component symbol represents similar element.So device, element and the program step described in following examples, only in order to the present invention to be described, is not in order to limit the scope of the invention.
Fig. 1 illustrates thetest strip 100 of the embodiment of the present invention, and Fig. 2 illustrates the STRUCTURE DECOMPOSITION figure oftest strip 100, and with dotted line, shows the corresponding relation of each yuan ofassembly.Test strip 100 of the present invention comprises insulatedsubstrate 110,conductive layer 120, insulating mathigh level 130 and upper cover 150.Conductive layer 120 compriseselectrode group 122 andidentification unit 127, and whereinidentification unit 127 comprises composedcomponent group 128 and link component group 129.In this embodiment, composedcomponent group 128 comprises 5 composedcomponent 128a, 128b, 128c, 128d and 128e, andlink component group 129 comprises twolink component 129a and129b.Link component 129a and each composed component one end be connected,link component 129b is connected with the other end of each composed component, as shown in Figure 2.In this embodiment, the workingelectrode 123 that electrodegroup 122 comprises mutually insulated andreference electrode 124.
The present invention does not limit quantity, the shape of contained composed component inidentification unit 127, andidentification unit 127 can be arranged at arbitrary surface ofinsulated substrate 110, does not limit toelectrode group 122 on same surface.In general, composedcomponent group 128 comprises at least one hole that partially or completely runs through insulated substrate 110 (as the element H in Fig. 2) on composed component wherein, makes to form open-circuit structure between this composed component and link component group 129.Hole H runs through insulatedsubstrate 110 completely in the present embodiment, and it is consisted of the through hole h1 oninsulated substrate 110, through hole h2 inconductive layer 120 and the through hole h3 on insulating mat high level 130.By controlling quantity and the position of hole, can change the electrical property feature (as the resistance value between twolink component 129a and 129b) ofidentification unit 127, and can distinguish accordinglytest strip 100.
Insulated substrate 110 has electrical insulating property, and its material can be including but not limited to: Polyvinylchloride (PVC), glass fibre (FR-4), polyester (polyester), bakelite plate (bakelite), poly terephthalic acid diethylester (PET), polycarbonate (PC), polypropylene (PP), tygon (PE), polystyrene (PS) or pottery etc.
The material of conductive layer 120 can be any conductive materials, such as carbon paste, gold and silver glue, copper glue, carbon silver epoxy glue or its analog and combination etc.In an embodiment, conductive layer 120 is comprised of conductive silver glue-line and the conductive carbon bisque that is placed on conductive silver glue-line, and generally speaking, the impedance of conductive carbon bisque is much larger than conductive silver glue-line or other metal glue-lines.Identification unit 127 can be arranged in pairs or groups by conductive silver glue-line and conductive carbon bisque, and the resistance value being formed to calculate each composed component, as the arrangement design of test strip.Each composed component can have respectively different length or width and have the resistance of different resistances to form, and between each composed component and two link components, optionally forms access structure or pass through hole and form open-circuit structure.In general, when N composed component has different resistance values and arrange in pairs or groups different pore quantities and position separately, capable of being combinedly go out 2nplant resistance value.When test strip 100 is inserted measuring equipment, measuring equipment can be distinguished test strip 100 according to the resistance value between two link components, also can and then adopt corresponding correction parameter or pattern and measures.Should be noted that composed component 128 of the present invention is not limited to resistance.
The present invention does not limit the arrangement of workingelectrode 123,reference electrode 124 andidentification unit 127, does not also limit the quantity of electrode, can be according to required other electrodes that increases of practical application.In general, as long as insulated from each other enough between each electrode and identification unit.
Insulating mathigh level 130 is placed onconductive layer 120, and insulating mathigh level 130 comprises opening 132a, to expose a part for conductive layer 120.Generally speaking, as long as opening 132a can expose the workingelectrode 123 of part and thereference electrode 124 of part is enough, the present invention does not limit the shape of opening 132a.In addition, the design of insulating mathigh level 130 also exposes another part ofconductive layer 120, so thatconductive layer 120 can be electrically connected with measuring equipment (as 630 of Fig. 6).The material of insulating mathigh level 130 can be including but not limited to PVC insulating tape, PET insulating tape, heated drying type insullac or ultraviolet curing type insullac.
Upper cover 150 is placed on insulating mathigh level 130, and covers opening 132a.Part betweeninsulated substrate 110 andupper cover 150 forms the sampler space (being reaction zone 132) of tool capillary force.When the area of the sampler space is fixedly time, its volume can be depending on the thickness of insulating mat high level 130.Generally speaking, the thickness of insulating mathigh level 130 is between approximately 0.005 millimeter to approximately 0.3 millimeter, so not subject to the limits.In addition, in manufacture process, the insulating mathigh level 130 that cuts outopening 132a can be positioned oninsulated substrate 110 andconductive layer 120, the mode that can also print is avoidedopening 132a and the region in order to be electrically connected with measuring equipment, and directly forms insulating mathigh level 130 on theinsulated substrate 110 of part andconductive layer 120.
Test strip 100 of the present invention also comprises the respondinglayer 140 that is placed inopening 132a, it has the ability of selectivity identification biomaterial or signal, wherein the material of respondinglayer 140 is different and different with sample, for example can be oxidoreducing enzyme or electron mediator (as sub-iron type materials), in order to produce chemical reaction with sample.Generally speaking, atleast reference electrode 124 and the workingelectrode 123 of cover part of respondinglayer 140.
Upper cover 150 of the present invention can be transparent or semitransparent material, to facilitate observingresponse district 132 whether to insert sample, detects before avoiding sample not insert, and the result leading to errors.The lower surface that approachesreaction zone 132 ofupper cover 150 can be coated with water wetted material, to strengthen the capillary action ofreaction zone 132 inner walls, in order to more quickly and effectively by Sample introduction reaction zone 132.Upper cover 150 also comprises theair hole 153 corresponding to opening 132a end, and in order to discharge gas inreaction zone 132 to strengthen capillary action, generally speaking,air hole 153 isnear opening 132a end.The present invention does not limit the shape ofair hole 153, and for instance,air hole 153 can be circle, ellipse, rectangle, rhombus etc.
Fig. 3, Fig. 4, Fig. 5 A and Fig. 5 B test strip 300,400,500a and the 500b for illustrating according to different embodiments of the invention, must notice and not illustrate for convenience of description insulating mat high level and upper cover.With reference to figure 3, the working electrode 323 that test strip 300 comprises insulated substrate 310 and mutually insulated, reference electrode 324, sensing electrode 325, two detecting units 326 and identification units 327, wherein identification unit 327 comprises composed component group 328 and link component group 329.In this embodiment, composed component group 328 comprises five composed component 328a, 328b, 328c, 328d and 328e, and link component group 329 comprises link component 329a and 329b, wherein two ends of each composed component are connected with link component 329a and 329b respectively, form in parallel.Test strip 300 has also comprised two hole P1 and P2 is upper in composed component 328a and 328d, makes composed component 328a, 328d form open-circuit structure respectively and between link component group 329.When test strip 300 is electrically connected with measuring equipment (as the measuring equipment 630 that Fig. 6 illustrated), composed component 328b, 328c and 328e can form respectively three electrical loops, composed component 328a, 328d are respectively and open circuit, therefore measuring equipment will see through total electrical property feature (as total equivalent impedance) that link component group 329 measures by composed component 328b, 328c and the formed loop of 328e, and identification test strip 300 thus.
In the embodiment shown in fig. 3,sensing electrode 325 is door type electrode, and itself and workingelectrode 323 andreference electrode 324 are electricallyinsulated.Sensing electrode 325 is arranged between workingelectrode 323 andreference electrode 324, in order to the electric connection betweensensing test strip 300 and measuring equipment (as the measuringequipment 630 that Fig. 6 illustrated).In general,sensing electrode 325 sees through loop and produces electric signal, and reaches the effect of specifying start.For instance, whentest strip 300 is inserted after measuring equipment, sensingelectrode 325 can and measuring equipment between form loop, and start measuring equipment.
The major function of detectingunit 326 is whether confirmatory sample suitably covers reaction zone 332.In general, detectingunit 326 is bottoms of correspondingreaction zone 332 and arranging, and makes, when liquid sample injectsreaction zone 332, will sequentiallytouch reference electrode 324, workingelectrode 323 and detecting unit 326.Once sample arrives two detectingunits 326 of bottom, reaction zone, this sample can be as the electric connection of 326 of these two detecting units, and the resistance value between it is diminished.Detectingunit 326 can by with substrate on other electrodes or electrical structure be coupled, and reach the object that realizes multinomial measuring ability on the substrate of small size.In this embodiment, one end of two detectingunits 326 is connected withreference electrode 324 andlink component 329a respectively.So, measuring equipment can provide voltage betweenreference electrode 324 andlink component 329a, once sample arrives the detectingunit 326 of 332 bottoms, reaction zone, just can make has enough current flowing betweenreference electrode 324 andlink component 329a, and confirmatory sample suitably covers reaction zone 332.In other embodiments, one end of two detectingunits 326 can be connected to respectively other electrodes, for example, be connected to respectively workingelectrode 323 andlink component 329b.
With reference to figure 4, the working electrode 423 that test strip 400 comprises insulated substrate 410 and mutually insulated, reference electrode 424, two detecting units 426 and identification units 427, wherein identification unit 427 comprises composed component 428a, 428b, 428c and link component 429a, 429b, and two ends of each composed component are connected with link component 429a and 429b respectively.One end of two detecting units 426 is connected with reference electrode 424 and link component 429a respectively, in order to confirmatory sample, whether suitably covers reaction zone 432.In other embodiments, one or two in detecting unit 426 can be absolute electrode, and with other electrode mutually insulateds.Test strip 400 has also comprised two hole P1 and P2 is upper in composed component 428a and 428c, makes 429 of composed component 428a and 428c and link components form open-circuit structure.Hole P1 and P2 can be the through hole that runs through insulated substrate 410 and also can be the groove that does not run through insulated substrate 410.In this embodiment, with the conductive carbon powder of different length and shape, form each composed component, to produce the composed component with different resistance values.In general, the resistance value of composed component can utilize the length of conductive carbon powder or width and adjust, and further, other metal glue-lines (as elargol layer) of can arranging in pairs or groups are adjusted.
In Fig. 5 A,test strip 500a has hole P1 on composed component, and in order to destroy the electrical loop between this composed component and Connection Element, its failure mode can be adopted part or complete and run through insulated substrate and reach.In Fig. 5 B,test strip 500b has two hole P1 and P2 on two different composed components.Therefore, theidentification unit 527a oftest strip 500a and theidentification unit 527b oftest strip 500b, by having different electrical property features, can distinguishtest strip 500a and 500b thus.For instance, whentest strip 500a or 500b insert measuring equipment, measuring equipment can see through receive the signal of the electrical property feature ofcorresponding identification unit 527a or 527b, and isdistinguished test strip 500a and 500b, and then adopts corresponding correction parameter or pattern measures.
In other embodiments of the invention, can assigned work electrode or measure the diverse location of electrode and reach and start measuring equipment or other sensing function.For example, with reference to figure 5A and 5B, in the test side ofreference electrode 524a or 524b (by being connected to the end points of measuring equipment), 2 check point S1, S2 are set, wherein check point S2 can be in order to ground connection, when two check point S1, S2 and measuring equipment connect into electrical loop, specify and start measuring equipment.
The present invention does not limit the quantity of composed component, also should be appreciated that, the quantity of composed component, shape and electrically can according to practical application, be set voluntarily by deviser, wherein each composed component optionally destroys the electric connection between itself and link component group with hole, can form thus a plurality of different equivalent impedances.In other words, when thering is N composed component, by capable of being combined, go out 2 at mostnindividual identification code.That is, by optionally destroying each composed component, and coordinate the impedance magnitude of each composed component, can be combined into the identification code of a plurality of uniquenesses.Identification unit can be thus in order to represent the test strip of difference in functionality, or the test strip of different batches.The mode of destroying composed component loop can be the through hole that runs through insulated substrate or the groove that does not run through insulated substrate.The present invention also not the shape of confinement groove or through hole with size.Should be noted, a N of the present invention composed component can be various passive elements, as resistance, inductance or electric capacity etc.
The block schematic diagram that Fig. 6 is thebiochemical sensing system 600 that illustrates according to the embodiment of the present invention, its inclusiontest test piece 300 and measuring equipment 630.Test strip 300 comprises workingelectrode 323,reference electrode 324, sensingelectrode 325, two detectingunits 326,identification unit 327 and two hole P1, P2, whereinidentification unit 327 comprises composedcomponent 328a, 328b, 328c, 328d, 328e andlink component 329a, 329b, and hole P1 and P2 lay respectively at composedcomponent 328a and 328d is upper, as described in Figure 3.The approach that provides each composedcomponent 328a, 328b, 328c, 328d, 328e to be electrically connected to measuringequipment 630 is provided forlink component 329a of the present invention, 329b.
Measuringequipment 630 comprisesconnector 640 and is coupled to themicroprocessing unit 650 ofconnector 640, the built-innumerical data 655 ofmicroprocessing unit 650 wherein, and it can be such as being correction parameter, detecting pattern or other information etc.Connector 640 has the splicing ear of corresponding each electrode andidentification unit 327, wherein workingelectrode 323,reference electrode 324, sensingelectrode 325, detectingunit 326 andidentification unit 327 see through and the splicing ear ofconnector 640 between join and be electrical connected with measuringequipment 630.
Whentest strip 300 is connected withconnector 640, betweensensing electrode 325 andconnector 640, will form loop, and makemicroprocessing unit 650 start measuring equipment 630.In addition, because a plurality of composed components ofidentification unit 327 have respectively different conditions, therefore will there is different forms from the connection of 640 of connectors, produce therefrom the signal of the represented identification code ofcorresponding identification unit 327 to microprocessing unit 650.For instance, whentest strip 300 is electrically connected with measuringequipment 630, composedcomponent 328a and 328d cannot form and be electrically connected withconnector 640, and only composedcomponent 328b, 328c and 328e can formelectrical loop.Connector 640 can see throughlink component 329a and 329b receives the signal of corresponding this electrical property feature, and this signal is sent to microprocessor 650.650 of microprocessing units can will carry out identification according to this signal, and indata 655, select the parameter of corresponding this signal or pattern to carryout.Measuring equipment 630 also comprises to show thedisplay 660 of various measurements, and in order to thepower supply 670 of required power supply to be provided.In another embodiment,display 660 andpower supply 670 can be external device, and are not contained in measuringequipment 630.
In brief, identification unit of the present invention is for identification and specifies in data built-in in measuring equipment, wherein in measuring equipment, has multiple array corresponding to correction parameter, detecting pattern or other information of the represented identification code of identification unit in test piece.Disclosed biochemical sensing system not only reaches object that need not cipher card and reduces cipher card manufacturing cost, improved property easy to detect and can avoid the careless mistake of manual operation.
The foregoing is only the preferred embodiments of the present invention, not in order to limit claim of the present invention; All other do not depart from being equal to change or modifying of completing under disclosed spirit, all should be included in claim.