JP2009115516A - Biosensor - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a new method for automatically recognizing biosensor calibration data by a very simple manufacturing process and a method for forming an identification mark therefor.
In a biosensor 100 having a connector mounting portion 150 having an output terminal 112 at one end portion, the connector mounting portion 150 has a number of light low-transmitting regions required in advance by a conductive paste or the like. 162, two kinds of marks 161 constituting an identification mark (bit pattern) are formed by removing unnecessary light low-transmitting areas 162 by a method such as cutting after a trial test performed after manufacturing; The mark 161a and the light low-transmittance mark 161b are formed. When the biosensor 100 is attached to the measuring instrument 1, the bit pattern formed by the mark 161 is detected by optical means including the light emitting element 31 and the light receiving element 32, and necessary calibration data is automatically obtained from its existing position. Selected.
[Selection] Figure 6

Description

  The present invention relates to a biosensor, specifically, a biosensor provided with an automatic recognition mark.

  In recent years, biosensors that enable measurement of in-vivo substances such as blood glucose levels using enzyme reactions and antigen-antibody reactions have been developed. Such biosensors have different sensor sensitivities due to differences in the lots of enzymes used, production lines, detection electrode formation, enzyme application, etc., and the sensor sensitivities are the same among all production lots. Not necessarily. In order to calibrate the difference in sensor sensitivity, for example, the manufacturer adjusts the sensor sensitivity for each production lot and then ships a calibration sensor for adjusting the sensor sensitivity of the measuring instrument for each product package. Or assigning an identification number to each production lot. Then, the user calibrates the measuring instrument using the calibration sensor in advance, or selects the calibration data stored in the measuring instrument in advance by inputting the identification number and calibrates the measuring instrument. It is carried out. However, in any of the methods, the measurer himself has to calibrate, which not only gives the measurer the trouble of calibrating, but also gives rise to the problem that accurate measurement values cannot be obtained if calibration is forgotten. In addition, if the measuring device measures a plurality of target items, there is a problem that the calibration is not correctly performed due to a mistake in the calibration sensor.

  In order to solve such problems, for example, in Japanese Patent Laid-Open No. 2001-311711 (Patent Document 1), a slit for identifying information for calibration is provided in the output electrode of the biosensor, and the installation of this slit is provided. A method for automatically recognizing calibration data based on a pattern is disclosed.

  In Japanese Patent Laid-Open No. 10-332626 (Patent Document 2), a calibration electrode is provided separately from the output electrode on a substrate on which an output electrode constituting a biosensor is formed, and the output electrode and the calibration electrode are provided. Disclosed is a method for automatically recognizing calibration data selected by a closed circuit formation pattern formed between and.

  International Publication WO2003 / 76918 (Patent Document 3) discloses a biosensor in which a protrusion is provided at the tip of a substrate on which an output electrode constituting the biosensor is formed, or a protrusion is provided on the back surface of the substrate. Is disclosed. Here, the formation position of these protrusions and projections is recognized using the capacitance change of the capacitor formed on the connector for mounting the sensor, and calibration data is automatically recognized from this formation position, or the output electrode An electrode different from the output electrode is provided on the substrate on which the electrode is formed, and the formation position of this electrode is automatically recognized by utilizing the capacitance change of the capacitor formed between the electrode and the sensor mounting connector.

  Further, in Patent Document 3, as another method, a through hole is formed at the tip of a substrate on which an output electrode constituting a biosensor is formed, and the position of the through hole is defined as a leaf spring shape passing through the through hole. A method for recognizing using the conduction state of the position detection electrode is disclosed.

JP 2001-311711 A JP-A-10-332626 International Publication No. WO2003 / 76918

  However, in the method of forming a slit in the electrode, a high level of technology is required for forming the slit. In addition, it is conceivable that a slit formation failure or an electrode short-circuit is likely to occur, and a calibration data identification failure is likely to occur. Further, in the method of forming the calibration electrode and the protruding portion or the protruding portion for changing the capacity, it is necessary to form a new electrode or protruding portion after manufacturing, and there is a problem that the manufacturing process of the biosensor becomes complicated. is there. In the method of passing the position detection electrode through the through hole of the biosensor, accuracy is required for positioning of the through hole.

  Further, in the method of forming the calibration electrode, the counter electrode (connector pin) that forms a closed circuit between the output electrode and the calibration electrode is formed in the connector, and the protrusion or the like is formed to change the capacitance. In the method in which the capacitor forming counter electrode corresponding to the calibration electrode is passed through the through hole and the position detecting electrode is passed through, it is necessary to provide the position detecting electrode on each connector. By the way, there are many technical restrictions in providing such a detection means in a connector, and there are restrictions in the number of counter electrodes etc. which can be provided in the connector mounting part of a biosensor. For this reason, it is considered that the number of calibration data to be prepared is limited, and there is a possibility that various biosensors cannot be supported.

  The present invention has been made in view of the above problems of the background art, and an object of the present invention is to provide a new method for automatically recognizing biosensor calibration data by a relatively simple manufacturing process, and more preferably. Is to provide a recognition method capable of handling a large number of calibration data.

  Therefore, in the present invention, an identification mark composed of one or a plurality of marks (excluding through-holes formed outside the connector mounting area) that can be identified by optical means is formed.

  The present invention uses an optical means such as light transmission or light reflection, and provides an identification mark from a mark that can be identified by the difference in transmission or reflection. For this purpose, the identification mark can be provided by a very simple method such as formation of a light-impermeable film or light-reflecting film by coating, or deletion of a light-impermeable film or light-reflecting film formed in advance.

  Hereinafter, the present invention will be described in detail with reference to the accompanying drawings. FIG. 1 is a schematic perspective view of a biosensor according to an embodiment of the present invention, and FIG. 2 is an exploded perspective view of the biosensor. In FIG. 2, the adhesive layer 140 and the like between the substrate 110 and the cover 120 are omitted. However, the embodiment shown below is an exemplification, and the present invention is not limited to the following embodiment, and all the modifications included in the scope of the claims and equivalents thereof are included in the present invention. It is intended to be included.

  As shown in each drawing, the biosensor 100 includes an adhesive layer between the cover 120 and the substrate 110 so as to form a sample space 130 between the cover 120 that is an insulating plate member and the substrate 110 that has optical transparency. 140 is bonded together. The biosensor 100 has a sample introduction port 101 connected to the sample space 130 at the tip thereof. Further, at the rear end of the sample space 130, vent holes 141 connecting the sample space 130 and the outside of the biosensor 100 are extended on both sides thereof. A pair of electrodes 111 is formed on the substrate 110 so as to face the sample space 130. A connector mounting portion 150 where the substrate 110 is exposed is provided at the end of the substrate opposite to the sample introduction port 101, and the connector mounting portion 150 takes out a voltage electrically connected to the electrode 111 and the conductor path 113. The terminal (output electrode) 112 for use is exposed. The electrode 111, the conductor track 113, and the terminal 112 are formed by a method such as sputtering or vapor deposition of conductive metal, screen printing of a conductive paste, or the like. The cover 120 is provided with a reagent layer 121 that faces the sample space 130 and reacts with a sample (specifically, a body fluid such as blood). The pair of electrodes 111 and the reagent layer 121 constitute a measurement unit. An example of such a biosensor 100 is a chip in which a board member and a cover are produced by bending a plate member as described in, for example, International Publication WO2005 / 10591. However, the structure of the biosensor 100 of the present invention may not be the structure shown in Patent Document 2, and the present invention is applicable to any biosensor 100 having a structure in which the connector mounting portion 150 is provided at one end. Can be applied.

  The connector mounting part 150 is provided with a marker forming region 160 between the two terminals 112. In the marker forming region 160, one or more marks 161 that can be detected by optical means, for example, three light-transmitting marks 161a and one light-low-transmitting mark 161b in the figure are formed. . These marks 161 are for automatically recognizing calibration data required for calibration of the measuring instrument 1. An identification mark (bit pattern) in which the positions where these two types of marks 161a and 161b are present, that is, a light-transmitting region and a light-low-transmitting region having low light transmission compared with the region are indicated by binary values. ), And this identification mark determines calibration data used for calibration.

  The presence or absence of each mark 161 may be detected by optical means. Examples of the optical means include not only a means for measuring light transmittance as described above but also a means for measuring light reflectivity. When measuring light transmissivity, (1) a method of determining that “the mark is present” when the transmittance is low, “no mark” when the transmittance is high, and (2) “mark” when the transmittance is high. Any of the methods for determining “Yes” and “No mark” when the transmittance is low may be used. Further, when measuring reflectivity, (3) a method of determining that “there is a mark” when the reflectance is high, and “no mark” when the transmittance is high, and (4) a case where the reflectance is low. Any of the methods of determining that “there is a mark” and “there is no mark” when the reflectance is high may be used. That is, in the present invention, two types of marks 161 having different optical characteristics are used, and the marks 161 that can relatively distinguish the light transmittance and light reflectance of each mark 161 are used.

  The illustrated biosensor 100 uses a substrate 110 having a high light transmission property. For example, a material having a low light transmission property such as an ink, a seal, a conductive film containing gold, copper, carbon, etc. A mark 161b having low light transmittance is formed by application of a transparent substance or the like. That is, the low light-transmitting mark 161b is formed by applying such low-light-transmitting ink or the like, and the light-transmitting mark 161a is formed by not performing such coating or the like. Therefore, if the marker forming region 160 is irradiated with light and the light passes through the substrate 110 and it can be recognized that the low light-transmitting mark 161b does not exist, the light-transmitting mark 161a is formed there. I can judge.

  The identification pattern formed by the two kinds of marks 161 formed in this way, that is, the bit pattern formed by the combination of the light transmissive mark 161a and the light transmissive mark 161b varies depending on the production lot of the biosensor 100, and is manufactured. Determined after later trial test. The maximum number of marks 161 required for the construction of the identification mark (the total of the light transmissive mark 161a and the light transmissive mark 161b) differs depending on the number of calibration data prepared in the measuring instrument 1 in advance. For example, if there are three types of calibration data prepared in the measuring instrument 1, three types of bit patterns are required, so at least two marks 161 are required. Therefore, the required maximum number of marks 161 in this case is 2. If 15 calibration data are prepared, 15 kinds of bit patterns are required, and therefore, four marks 161 are required at a minimum. Therefore, the required maximum number of marks 161 in this case is 4.

  The size of each mark 161 can be appropriately determined depending on the optical device for identifying the presence or absence of the mark 161, that is, the sensitivity of the light receiving element 32 or the light emitting element 31, the light transmittance or light reflectivity of the mark 161. For example, a rectangular mark 161 having a width of 0.1 to 0.5 mm and a length of 0.3 to 0.8 mm is exemplified. The shape is not limited to a rectangular shape, and any shape can be used as long as it can be detected by optical means such as a circle, an ellipse, and a square.

  Of the marks 161, the low-light-transmitting mark 161b is formed by a method such as applying ink at a required position or applying a seal after a trial test performed after manufacturing. Further, the light forming region 162 for forming a mark of the maximum number or more necessary in advance at the time of manufacturing is formed in the marker forming region 160, and the unnecessary light transmitting region 162 is removed after the trial test, A method of forming the light-transmitting mark 161a and using the remaining light-low-transmitting region 162 as the light-low-transmitting mark 161b is preferable. For example, when 10 pieces of calibration data are prepared in the measuring instrument 1, 10 types of bit patterns are required. Therefore, it is sufficient to have a maximum of four light low-transmitting marks 161 b. Therefore, as shown in FIG. 3, at the time of manufacturing the biosensor 100, at least four mark light-transmitting regions 162 for forming a mark are formed in the marker-forming region 160 (FIG. 3A), and the result of the trial test. Then, the light low transmission region 162 at the unnecessary position is removed ((b) in the figure). The low light transmissive region 162 after being removed is recognized as a light transmissive mark 161a (shown as a region surrounded by a broken line in the figure), and the remaining light low transmissive region 162 that has not been removed is light low. It is recognized as a transparent mark 161b (shown as a region surrounded by a solid line in the figure).

  As a method of removing the low light transmission region 162, for example, a method of removing the seal if it is made of a seal, a method of removing the ink by a chemical method or a physical method if it is made of an ink, such as a laser Examples thereof include a method of cutting by machining or the like and a method of punching by punching or the like. Moreover, when it consists of an electroconductive film, the method of removing by physical methods, such as drilling by laser processing, punching, etc. is illustrated. The removal method has the advantage that positioning does not require high accuracy and processing can be performed very easily compared with post-application of ink, post-sealing, and post-formation of electrodes. Then, it may be a relatively rough processing accuracy that can be detected as being light transmissive. The method using a conductive film can use the same material as the terminal 112 and the conductor path 113. Since the conductive film can be formed by printing the conductive paste in the same process as the formation of the terminals 112 and the like, there is also an advantage that the manufacture can be easily performed. Furthermore, since the presence or absence of the mark 161 is detected by optical means, the identification information can be detected in a non-contact state with the biosensor 100. For this reason, the misidentification based on the contact failure by the increase in the frequency | count of a measurement which was pointed out by patent document 3 can be prevented.

  FIG. 4 is a block diagram showing a configuration of the measuring instrument 1 in which the biosensor 100 is used, and FIG. 5 is a schematic configuration diagram in which the measuring instrument 1 in which the biosensor 100 is used is partially broken. The measuring instrument 1 includes a connector 10 into which the connector mounting portion 150 of the biosensor 100 is inserted and takes out the output of the biosensor 100, a storage unit 20 storing calibration data, and the presence / absence of the mark 161 of the biosensor 100 (bit pattern). ), A verification unit 40 for verifying necessary calibration data based on the presence or absence of the detected mark 161, and a test value is calculated from the output of the biosensor 100 using the verified calibration data. And a display unit 60 for displaying the result.

  The detection unit 30 includes detection means for detecting the mark 161 output to the biosensor 100. The detection means in the measuring instrument 1 includes a light emitting element 31 such as a light emitting diode and a light receiving element 32 such as a photodiode. This detection means includes the same number of light-emitting elements 31 as the number of marks 161 that are considered to be the minimum. That is, when the required maximum number of four marks 161 is used, four light emitting elements 31 are provided. Each light emitting element 31 is mounted on the circuit board 3 arranged in the housing 2 of the measuring instrument 1 so as to correspond to the position of each mark 161, and emits light toward the mark 161 from below the biosensor 100. To do. In other words, the light emitting element 31 is mounted so that the light emitting element 31 and the mark 161 have a one-to-one relationship, and each light emitting element 31 irradiates each mark 161 at a corresponding position. The detection unit 30 sequentially causes each light emitting element 31 to emit light at a constant light emission interval Δt.

  One light receiving element 32 is mounted on the circuit board 3 with the light receiving surface facing upward. Above the light emitting element 31, a light receiving portion 33 having a light receiving surface facing downward is disposed. The light receiving unit 33 and the light receiving element 32 are optically connected by a light guide path 34 made of an optical fiber or the like. On the light receiving element 32 side of the light guide path 34, a light leakage prevention cover 35 is press-fitted and fixed to the circuit board 3, and light received by the light receiving portion 33 is reliably received by the light receiving element 32. Therefore, the light emitted from the light emitting element 31 and passing through the light transmissive mark 161a is received by the light receiving element 32 through the light guide path 34 and converted into an electric signal.

  After the biosensor 100 is inserted into the socket 10, the detection unit 30 causes the light emitting elements 31 to emit light sequentially at the light emission interval Δt. When the light receiving element 32 receives the light transmitted through the substrate 110, an electric signal is generated. Therefore, the detection unit 30 detects the electric signal ON on the assumption that the light transmissive mark 161 a is formed. Accordingly, the presence position (bit pattern) of the mark 161 can be detected by making the timing at which each light emitting element 31 emits light correspond to the timing at which the light receiving element 32 receives light.

  FIG. 6 is an explanatory view showing an example of a detection method of the mark 161 in this detection means. This figure shows a case where a maximum of four marks 161 arranged in the insertion direction of the connector 10 are formed. As shown in FIG. 4A, among the four marks 161, light at positions A, B and D is shown. The low-transmitting region 162 is removed, and light-transmitting marks 161a are formed at positions A, B, and D, respectively. In the position C, the light low-transmitting region 162 is not removed, but the light low-transmitting mark 161b is formed. In addition, as shown in FIG. 4B, four light emitting elements A, B, C, and D are mounted corresponding to these four marks 161.

  Here, when the light emitting element A at the position A emits light, the light receiving element 32 receives light, so that the detection unit 30 detects the electrical signal ON. Then, the detection unit 30 recognizes that there is no light low-transmitting mark 161b at the position A and there is a light-transmitting mark 161a. Next, when the light emitting element B at the position B emits light, the light receiving element 32 receives light, so that the detection unit 30 detects the electrical signal ON. Then, the detection unit 30 recognizes that there is no light-transmitting mark 161b at the position B, and there is a light-transmitting mark 161a. Next, when the light emitting element C at the position C emits light, the light impervious mark 161b exists at the position C. Therefore, the detection unit 30 cannot detect the electrical signal ON. Then, the detection unit 30 recognizes that the position C has the low light-transmitting mark 161b and does not have the light-transmitting mark 161a. Finally, when the light emitting element D at the position D emits light, the light receiving element 32 receives light, so that the detection unit 30 detects the electrical signal ON. Then, the detection unit 30 recognizes that there is no light low-transmitting mark 161b at the position D and there is a light-transmitting mark 161a. As a result, the detection unit 30 detects a binary signal corresponding to the bit pattern of ON, ON, OFF, ON at a time interval of Δt, and outputs this binary signal to the verification unit 40. The collation unit 40 retrieves calibration data corresponding to this bit pattern from the storage unit 20 and outputs it to the calculation unit 50. The calculation unit 50 obtains a measurement value from the output voltage output from the biosensor 100 based on the calibration data, and outputs the measurement value to the display unit 60. In this way, the calibration data is automatically recognized, and the display unit 60 displays an accurate measurement value calibrated based on the calibration data.

  Similarly, although not shown, in the biosensor 100 in which the two light transmissive marks 161a are formed at the position B and the position D, the detection unit 30 is OFF, ON, OFF, ON in the same way as described above. The binary data is obtained, and calibration data corresponding to the binary signal is used. Further, the positions of the marks 161 do not need to be in series, and may be formed in a matrix of 2 × 2, for example, as shown in FIG. At this time, the light emitting elements 31 are arranged in a 2 × 2 matrix.

  In the above method, the case where a plurality of light emitting elements 31 and one light receiving element 32 are used is illustrated, but one light receiving element 32 is arranged for each light emitting element 31, or the light receiving elements 32 are arranged in an array. It is also conceivable to use a light receiving array that can detect the positional information of the received light. In this case, it is not necessary for the light emitting elements 31 to emit light sequentially at a constant time interval Δt, and all the light emitting elements 31 can emit light simultaneously. Further, a plurality of light receiving elements 32 may be arranged corresponding to the maximum number of marks 161 required, and a bit pattern may be detected by them and one light emitting element 31. However, when the light-transmitting mark 161a and the low-light-transmitting mark 161b are close to each other, if the light-emitting element 31 is caused to emit light simultaneously, the light-receiving element 32 corresponding to the light-low-transmitting mark 161b will be If the light transmitted through the transparent mark 161a is received, the light transparent mark 161a may be misidentified. Therefore, it is necessary to take preventive measures for avoiding erroneous recognition, such as setting an offset value that is detected when the light receiving element 32 is ON. As this misidentification prevention means, a method of making the light emission wavelength of the light emitting element 31 different from the light reception wavelength of the light receiving element 32 corresponding to the light emitting element 31 at a position where they interfere with each other can be exemplified.

  FIG. 8 is a plan view in which a part of a biosensor 100 according to still another embodiment of the present invention is omitted. This biosensor 100 also uses the light transmittance of the mark 161. However, in this biosensor 100, the entire light-transmitting region 162 is formed by applying a conductive film, ink, sticking a seal, or the like on the entire label forming region 160. It has become. Then, a predetermined position (enclosed frame shown by a solid line) of the light low-transmitting region 162 is removed to form three light transmitting marks 161a, and the region surrounded by the broken-line frame 163 is removed. It remains without being a mark 161b having low light transmittance. In this way, after forming the label formation region 160 so as to have low light transmission, a necessary region may be deleted to form the light transmission mark 161a. At this time, as shown in the drawing, it is preferable to provide a removal line 164 indicating a rough indication of the removal area in the marker formation area 160 formed in advance.

  FIG. 9 is a rear view of a biosensor 100 which is still another embodiment of the present invention. In this biosensor 100, the label formation region 160 is formed in a region other than the connector mounting portion 150 on the back surface of the substrate 110. In this biosensor 100, each mark 161 constituting the identification information (bit pattern) is either a light reflective mark 161c or a light low reflective mark 161d. Mark 161c and one light low-reflectivity mark 161d are formed. In this biosensor 100, the light reflective mark 161c having a high reflectance can be detected as having an identification mark. The light reflective mark 161c is formed, for example, by applying a light reflective substance or applying a seal, and the area without application of the substance or sticker is recognized as having no low light reflective mark 161d. For example, as shown in FIG. 10, the biosensor 100 uses a measuring instrument 1 in which a light emitting element 31 and a light receiving element 32 are mounted on a circuit board 3.

  In many cases, the cover 120 is made of a material having low light transmission, and a conductive path 113 is formed between the cover 120 and the substrate 110, so that high light transmission cannot be desired. Further, the substrate 110 may have low light transmittance. When the light transmittance cannot be desired in this way, the mark 161 can be recognized using the light reflectance. In particular, as shown in FIG. 9, when the mark 161 is formed in an area other than the connector mounting portion 150, a wider area can be used than in the case where the mark 161 is formed in the connector mounting portion 150. As a result, the number of marks 161 formed can be increased, and the number of calibration data required and the amount of information that can be held by the biosensor 100 can be increased. This makes it easier to use finer calibration data and to deal with many types of biosensors. Further, since the light emitting element 31 and the light receiving element 32 can be arranged outside the connector 10, restrictions on the arrangement thereof are reduced. Even in the case of utilizing the light reflectivity, as in FIG. 3, the minimum number of light reflectivity regions required at the time of manufacture or more than that are formed in the marker forming region 160, and unnecessary portions are removed. The light reflective region 161 can be deleted to provide the light reflective mark 161c, or the light low reflective mark 161d can be provided without being deleted. In addition, as shown in FIG. 11, a label formation region 160 that is a light reflective region is formed, an unnecessary region is deleted, a light low reflective mark 161d is formed, and is left without being removed. The region can also be a light reflective mark 161c. Of course, the mark 161 using such light reflectivity may be formed on the connector mounting portion 150.

  Further, light absorptivity can be used to form the mark 161. That is, a light-absorbing substance can be applied to form the light-reflective mark 161d, or the light-absorbing film applied in advance can be removed to form the light-reflective mark 161c. In this way, an identification mark (bit pattern) may be formed from the light reflective mark 161c and the light low reflective mark 161d.

  In the present invention, the number of light low-transmitting regions 162 (light reflecting regions that become light-reflective marks 161c) that will later become light low-transmitting marks 161b is the required maximum number, that is, the required bits. Although the minimum number of marks 161 necessary to form the pattern is necessary, it is also possible to form more light low transmission regions 162 (light low transmission marks 161b). For example, when 15 bit patterns are required, the required number of marks 161 is 4, but a number larger than that in advance, for example, six low light-transmitting marks 161b as shown in FIG. It may be formed. Then, as shown in FIG. 12B, a bit pattern may be configured by using the four low light transmission regions 162 on the right side of the six low light transmission regions 162, or FIG. As shown in FIG. 6, the two light low-transmitting regions 162 at the left end of the six light low-transmitting regions 162 can be deleted, and the remaining four light low-transmitting regions 162 can be used to form a bit pattern. . This is because the low-light-transmissive region 162 and the light-transmissive region that cannot be detected by the measuring instrument 1 do not affect the bit pattern recognition.

  As described above, in the present invention, it is only necessary to form the mark 161 that can be detected using optical means, that is, the mark 161 that can detect the presence or absence of the mark due to a difference in light transmittance or light reflectivity. Therefore, as described above, not only the position and number (bit pattern) of the mark 161 are detected, but also the mark 161 is formed using two kinds of inks and seals having different light transmittance and light reflectivity. The position and number of the marks 161, that is, the presence / absence of the mark 161 can be detected by judging the difference between the light transmittance and the light reflectance.

It is a schematic perspective view of the biosensor which is one Embodiment of this invention. It is a disassembled perspective view of the biosensor of FIG. It is explanatory drawing which shows the formation method of the identification mark in the biosensor of FIG. 1, Comprising: (a) is a figure which shows the state before forming an identification mark, (b) is a figure which shows the state after forming. It is a block diagram which shows the structure of the measuring device in which the biosensor of FIG. 1 is used. It is the schematic block diagram which fractured | ruptured partially the measuring device in which the biosensor of FIG. 1 was used. It is explanatory drawing which shows the detection method of the formation position of an identification mark, Comprising: (a) is a top view which abbreviate | omitted a part of biosensor, (b) is a figure which shows the light emission timing of a light emitting element, and the light reception timing of a light receiving element. is there. It is the top view which abbreviate | omitted a part of biosensor which is another embodiment of this invention. It is the top view which abbreviate | omitted a part of biosensor which is another embodiment of this invention. It is a rear view of the biosensor which is another embodiment of this invention. It is the schematic block diagram which fractured | ruptured partially the measuring device in which the biosensor of FIG. 9 was used. It is a rear view of the biosensor which is another embodiment of this invention. It is explanatory drawing which shows the formation method of the identification label | marker of the biosensor which is further another embodiment of this invention, Comprising: (a) is a figure which shows the light-low-transmission area | region before forming an identification label | marker, (b) ( (c) is a figure which shows an example of the identification mark formed after each trial test.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Measuring instrument 2 Housing | casing 3 Circuit board 10 Connector 30 Detection part 31 Light emitting element 32 Light receiving element 40 Collation part 50 Calculation part 100 Biosensor 110 Board | substrate 112 Terminal 113 Conductor path 120 Cover 150 Connector mounting part 160 Label formation area 161 Identification mark Constructing mark 161a Light-transmitting mark 161b Light-low-transmitting mark 162 Light-low-transmitting area

Claims (10)

A biosensor having a connector mounting region in which an output electrode is formed at one end and an identification mark,
The biomarker is characterized in that the identification mark is composed of one or a plurality of marks (excluding through-holes formed outside the connector mounting area) that can be identified by optical means.   2. The optical means according to claim 1, wherein the optical means comprises means for detecting light transmissivity or light reflectivity, and the presence or absence of an identification mark can be recognized by a difference in light transmissivity or light reflectivity of the mark. Biosensor.   The biosensor according to claim 1, wherein the identification mark is provided in the connector mounting region.   The biosensor according to claim 1 or 2, wherein the identification mark is provided outside the connector mounting region.   The mark may be applied or printed with a low light transmissive material or a light reflective material, a light low light transmissive or light reflective seal may be applied, a coated or printed light low light transmissive material or a light reflective material may be removed, and a connector may be attached. The biosensor according to any one of claims 1 to 4, wherein the biosensor is provided by any one of perforations in a region.   The biosensor according to claim 5, wherein the mark is made of a conductive film that is made of the same material as the output electrode formed in the connector mounting region. A method of forming an identification mark on a biosensor having a connector mounting region in which an output electrode is formed at one end,
Forming a light low transmission region or a light reflection region in a partial region of the exposed surface of the biosensor;
And a step of removing a predetermined region of the light low transmission region or the light reflection region. A method of forming an identification mark on a biosensor having a connector mounting region in which an output electrode is formed at one end,
Forming a light low transmission region or a light reflection region to be the maximum number or more of marks necessary for identification on the exposed surface of the biosensor;
A step of removing an unnecessary low light transmission region or light reflection region from the low light transmission region or light reflection region.   The method for forming an identification mark according to claim 7 or 8, wherein the removing method is a method of cutting or punching.   The method for forming an identification mark according to claim 7, wherein the low light transmission region or the light reflection region is formed in the connector mounting region.

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