JP5104526B2 - Biosensor measuring instrument and sensor system - Google Patents

Description

  The present invention relates to a biosensor measuring device and a sensor system, and more particularly to a measuring device that automatically identifies a biosensor.

  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. The user then 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 position where this electrode is formed is automatically recognized by using the capacitance change of the capacitor formed between the electrode and the sensor mounting connector. Yes.

  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.

  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. In addition, the method using a counter electrode and the method using a position detection electrode tend to cause a problem in that automatic identification cannot be performed correctly due to poor contact between the electrodes as the number of times the biosensor is used increases.

  In view of these problems, the present inventors have identified biosensors by optical means such as one or more through-holes for the purpose of avoiding technical limitations received from connectors and poor identification based on poor contact. Automatic determination of calibration data by providing an identification mark consisting of possible marks, emitting light from the light emitting element in the biosensor measuring device toward the mark, and determining the identification mark from the position of the received light receiving element. Proposes a method for identifying and has applied for a patent.

  However, when used for a long time, it is expected that the amount of emitted light will decrease or no light will be emitted at all due to a decrease in power supply voltage, failure or lifetime of the light emitting element. Then, even though the mark actually exists, it is mistaken that it does not exist, and correct calibration data is not selected, and as a result, an erroneous measurement value may be displayed.

  The present invention has been made in view of the above-described background art, and the object of the present invention is to make the light emitting element emit light again in the absence of a biosensor after measurement has been completed, thereby reducing the amount of light emitted or no light emission. This is to prevent erroneous display.

The biosensor measuring device of the present invention is a biosensor measuring device that measures using a biosensor with a mark that can be identified by optical means, and has the maximum number of marks required for biosensor identification. 1 to the maximum number of light-receiving elements that receive light from the light-emitting elements, and after the completion of the measurement, after taking out the biosensor, the light from the light-emitting elements is received, and the light reception An abnormality detecting unit for determining whether or not the measured value can be displayed on the extracted biosensor after determining whether the light emission amount of the light emitting element is normal based on the amount and detecting whether the light emission amount is good or bad. It is said.

  According to the present invention, it is possible to prevent an erroneous display due to a decrease in the amount of light emission caused by failure or lifetime of a light emitting element or non-light emission.

  Hereinafter, the present invention will be specifically described with reference to the accompanying drawings. FIG. 1 is a schematic cross-sectional view in which the biosensor measuring instrument 1 of the present invention is partly broken, FIG. 2 is a block diagram showing the configuration of the measuring instrument 1, and FIG. 3 is a flowchart showing a measurement procedure in the measuring instrument 1. . 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.

  The measuring instrument 1 has a circuit board 3 in which a connector 10 for mounting the biosensor 100 and taking out the output of the biosensor 100 is mounted in a housing 2. This measuring instrument 1 is necessary based on identification information composed of a storage unit 20 that stores calibration data, a detection unit 30 that detects an identification mark 160 provided on the biosensor 100, and an identification mark 160. The collation unit 40 that collates the calibration data, the calculation unit 50 that calculates the inspection value from the output of the biosensor 100 using the collated calibration data, and receives the light of the light receiving element 32, and the amount of received light From the above, it is determined whether or not the light emission amount of the light emitting element 31 is normal, and an abnormality detection unit 60 that detects a defect in the light emission amount and a display unit 70 that displays the results of the abnormality detection unit 60 and the calculation unit 50 are provided.

  The detection unit 30 includes detection means for detecting an identification mark 160 provided on the biosensor 100. This detection means comprises optical means, and includes a light emitting element 31 such as a light emitting diode and a light receiving element 32 such as a photodiode that receives light emitted from the light emitting element 31 and passing through or passing through the identification mark 160.

  The abnormality detection unit 60 includes a position storage area 61 for storing the position of the light emitting element 31 corresponding to the identification mark 160 detected by the detection unit 30, and light emission control for sequentially causing each light emitting element 31 to emit light after the biosensor 10 is taken out. The light emission amount of the light emitting element 31 corresponding to the position stored in the position storage area 61 and the light emission amount of each light emitting element 31 emitted by the control of the light emission control unit 62 is compared, and the light emission amount decreases. A light emission amount comparison unit 63 for detecting whether or not the light emission occurs.

  The illustrated measuring instrument 1 has the same number of light emitting elements 31 and 1 as the maximum number of identification marks 160 provided on the biosensor 100, that is, the maximum number of identification marks 160 necessary for identifying the identification information of the biosensor 100. Two light receiving elements 32 are provided. The number of necessary light emitting elements 31 varies depending on the number of calibration data prepared in advance in the measuring instrument 1 and other necessary information such as the measurement target of the biosensor 100. For example, when the identification information of the biosensor 100 is configured by four identification marks 160, four light emitting elements 31 are provided.

  Each light emitting element 31 is mounted on the circuit board 3 disposed in the housing 2 of the measuring instrument 1 corresponding to the position of each identification mark 160, and emits light from below the biosensor 100 toward the identification mark 160. Irradiate. In other words, when the maximum number of identification marks 160 is formed on the biosensor 100, the light emitting elements 31 are mounted so that the light emitting elements 31 and the identification marks 160 have a one-to-one relationship. The detection unit 30 sequentially causes each light emitting element 31 to emit light at a constant light emission interval Δt.

  On the circuit board 3, a light receiving portion 33 is disposed above the light emitting element 31 with the light receiving surface facing downward. Further, one light receiving element 32 is mounted on the circuit board 3 on the same surface as the substrate surface on which the light emitting element 31 is mounted with the light receiving surface facing upward. The biosensor 100 is mounted between the light receiving element 32 and the light receiving unit 33. 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. The light emitted from the light emitting element 31 and passing through the identification mark 160 is received by the light receiving element 32 through the light guide path 34 and converted into an electric signal.

  FIG. 4 is a schematic perspective view showing an example of the biosensor 100 used in the measuring instrument 1, and FIG. 5 is an exploded perspective view of the biosensor 100. In FIG. 5, the adhesive layer 140 is omitted.

  In the biosensor 100, the cover 120 and the substrate 110 are bonded together with an adhesive layer 140 so as to form a sample space 130 between the cover 120 and the substrate 110, which are insulating plate members, as shown in both drawings. Have a structure. 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 voltage extraction terminal (output electrode) 112 electrically connected to the electrode 111 and the conductor path 113 is exposed and formed on the connector mounting portion 150 at the end of the substrate opposite to the sample introduction port 101. ing. 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 reagent layer 121 and the pair of electrodes 111 constitute a sensor. 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 biosensor 100 used in the measuring instrument 1 of the present invention is not limited to the illustrated biosensor 100 having the structure shown in International Publication WO2005 / 10591.

  In an area other than the connector mounting portion 150, for example, in the illustrated case, three identification marks 160 including through holes are provided at positions penetrating the conductor path 113. The maximum number of identification marks 160 of the biosensor 100 is 4, and a circle indicated by a broken line indicates a position where one remaining identification mark 160 is to be formed. The formation position of the identification mark 160 may not be a position that penetrates one conductor path 113 as shown unless it is a position that affects the measurement result, for example, a position that does not penetrate the reagent layer 121 or the sample space 130. It does not matter even if the position crosses the two conductor paths 113. Further, from the viewpoint of the strength of the biosensor 100, a position passing through the three layers of the cover 120, the adhesive layer 140, and the substrate 110 is preferable, but an identification mark 160 is provided on the substrate 110 exposed when inserted into the connector 10. Also good. In order to reduce the influence on the measurement value, it is desirable to provide in a non-conductor path forming region such as between the two conductor paths 113.

The presence or absence of the identification mark 160 constitutes identification information (bit pattern) for automatically recognizing calibration data necessary for calibration. That is, an identification mark (bit pattern) in which the presence or absence of the identification mark 160 is indicated by a binary value is formed, and this identification mark determines calibration data used for calibration. In other words, in the identification mark 160 formed of a through hole, the position where the through hole is formed indicates a bit pattern, and necessary calibration data is determined from the bit pattern. The position and number of the identification marks 160 vary depending on the production lot of the biosensor 100, and the identification marks 160 are formed by stamping or drilling after a trial test after production. The maximum number of identification marks 160 differs depending on the number of calibration data prepared in advance in the measuring instrument 1, and for example, if the calibration data prepared in the measuring instrument 1 is 3 (= 2 ² −1) types. For example, a maximum of two identification marks 160 are formed. If 15 (= 2 ⁴ −1) calibration data are prepared, a maximum of four identification marks 160 are formed. Although the diameter of the through-hole as the identification mark 160 varies depending on the performance of the light receiving element 32 to be used, it may be a size that allows light to pass through. For example, the diameter is about 1 to 3 mm.

  When the biosensor 100 is inserted into the connector 10 of the measuring instrument 1 and preparation for measurement is completed, light is sequentially emitted from the light emitting elements 31 at the light emission interval Δt. When the light receiving element 32 receives light, an electric signal is generated. Therefore, if a through hole (identification mark 160) is formed, it can be detected as an ON signal. Therefore, the formation position of the identification mark 160 can be detected by matching the timing at which each light emitting element 31 emits light with the timing at which the light receiving element 32 receives light.

  FIG. 6 is an explanatory diagram showing an example of a method for detecting identification information in this detecting means. FIG. 6 shows a case where identification information is composed of a maximum of four identification marks 160 arranged in series. In the biosensor 100 shown in the figure, among the four identification marks 160, for example, position A, position B, Identification information is constituted by three identification marks 160 (indicated by solid circles) at the position D. Although the identification mark 160 is not formed at the position C, one remaining identification mark 160 (indicated by a broken line) is formed at this position as necessary. Then, four light emitting elements A, B, C, and D are mounted on the circuit board 3 as shown in FIG. 6B in correspondence with these identification marks 160.

  Now, 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 an ON electrical signal. Then, the detection unit 30 recognizes that the identification mark 160 is formed at the position A. At this time, the detection unit 30 stores the light emitting element A (position A) as position information of the light emitting element 31 in the position storage area 61 in the abnormality detection unit 60. 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 the identification mark 160 is formed at the position B. Next, when the light emitting element C at the position C emits light, since the identification mark 160 is not formed at the position C, the detection unit 30 cannot detect the electrical signal ON. Then, the detection unit 30 recognizes that the identification mark 160 is not formed at the position C. 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 the identification mark 160 is formed at the position D. 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. Then, the calculation unit 50 calculates a measurement value based on the extracted calibration data and the output from the biosensor 100. Note that the positions of the identification marks 160 do not have to be in series, and may be provided in a matrix of 2 × 2, for example. At this time, the light emitting elements 31 are also arranged in a 2 × 2 matrix.

  The abnormality detection unit 60 sequentially emits all the light emitting elements 31 after the biosensor 100 is taken out, and detects whether or not each light emitting element 31 emits light normally. When the light emission control unit 62 detects that the biosensor 100 is taken out from the measuring instrument 1, the light emission control unit 62 sequentially turns each light emitting element 31 again in the above example, for example, light emitting element A → light emitting element B → light emitting element C → light emitting element D. The lights are emitted in the order of. In the above example, since the identification mark 160 is detected at the position A, the light emitting element A (position A) is stored in the position storage area 61 as position information. The light emission amount comparison unit 63 stores the light emission amount of the light emitting element A stored in the position storage area 61, in other words, the light reception amount of the light receiving element 32 corresponding to the light emitting element A and the light emission amount of each light emitting element 31 (each light emitting element 31). And the light receiving amount of each light emitting element 31 is determined to be equal to or larger than the reference light emitting amount. If all the light emitting elements 31 are large, the abnormality detecting unit 63 outputs to the computing unit 50 that all the light emitting elements 31 are normal, and the computing unit 50 is based on the previously obtained calibration data. The measurement value is corrected from the output of the biosensor 100 and the result is output to the display unit 70.

  Here, consider a case where the light emitting element B is abnormal and does not emit light normally. In this case, the detection unit 30 recognizes the bit pattern of ON, OFF, OFF, ON, and as a result, the calibration is different from the calibration data corresponding to the bit pattern of ON, ON, OFF, ON which is correct calibration data. Data is selected incorrectly. Thereafter, when the biosensor 100 is taken out, the light emission amount comparison unit 63 compares the light emission amount of the light emitting element A and the light emission amount of each light emitting element 31 as described above. It is determined that the amount of light emission is smaller. Then, the abnormality detection unit 60 detects that the light emitting element B does not emit light normally, and displays an error on the display unit 70 without correcting the measurement value.

  When there is an abnormality in the light emitting element A, the detection unit 30 recognizes a bit pattern of OFF, ON, OFF, ON. In this case, the light emitting element B (position B) is stored in the position storage area 62 as position information. Then, the light emission amount comparison unit 63 makes a determination based on the light emission amount of the light emitting element B, and detects that the light emitting element A does not emit light normally.

  Next, the measurement procedure in the measuring instrument 1 will be described with reference to the flow chart of FIG. 3. First, when the biosensor 100 is inserted into the connector 10 of the measuring instrument 1 and the preparation for measurement is completed, the attachment confirmation of the biosensor 100 is confirmed. Is performed (S1). When the attachment confirmation is completed, the calibration data used by the automatic recognition of the biosensor 100 is determined by the above method (S2). When the output from the biosensor 100 is measured (S3), a measurement value corrected by the determined calibration data is obtained (S4). Then, the calculation unit 50 prompts the user to take out the biosensor 100 based on the display or sound of the display unit 70 and confirms the removal of the biosensor 100 (S5).

  Next, when it is confirmed that the biosensor 100 is taken out from the measuring instrument 1, the light emission control unit 62 in the abnormality detection unit 60 sequentially causes each light emitting element 31 to emit light, for example, the light emitting element A (S6). In the above example, since the light emitting element A (position A) is stored as position information in the position storage area 61, the light emission amount comparison unit 63 uses the light emission amount of the light emitting element A as the reference light emission amount. The amount of light emission is compared (S7). At this time, since the light emitting element A is normally emitting light, the process returns to step S6, and the light emission control unit 62 next causes the light emitting element B to emit light. Then, the light emission amount comparison unit 63 compares the light emission amount with the reference light emission amount (S7). In this way, when the abnormality detection unit 60 detects that the light emission amounts of all the light emitting elements 31 are larger than the reference light emission amount and all of the light emission elements are normally emitting (S8), the light emitting elements 31 are all normal in the calculation unit 50. And outputs the measurement value to the display unit 70 (S9). In step S7, for example, when there is an abnormality in the light emitting element B and the light emission amount of the light emitting element B does not satisfy the reference light emission amount, an error is displayed on the display unit 70, and the measurement is performed without displaying the measurement value. End.

  Similarly, although not shown, in the biosensor 100 in which the through holes are formed as the identification marks 160 at the positions B and D, the detection unit 30 is OFF, ON, OFF, ON 2 in the same way as described above. A value signal is obtained, and calibration data corresponding to the binary signal is used. In this case, whether or not the other light emitting elements A, C, and D are normally emitting light is detected on the basis of the light emission amount of the light emitting element B corresponding to the position B. When confirmed, the measured value corrected by the calibration data is displayed. On the other hand, when a defect in the light emission amount is detected, an error is displayed without displaying the measured value. Of course, even when the abnormality detection unit 60 detects a defect in the light emission amount, the error display is not immediately performed and the measurement is not finished, but the light emission amounts of all the light emitting elements 31 are compared and all the light emitting elements 31 are compared. After determining the quality, an error display may be performed, and at the same time, the position of the defective light emitting element 31 may be displayed.

  As described above, the measuring instrument 1 can correctly read the identification mark 160 attached to the biosensor 100 by the light emitting element 31 and the light receiving element 32. In addition, the biosensor 100 can be identified in a non-contact state with the biosensor 100, and identification failure due to an increase in the number of uses is prevented.

  Further, the light emitting element 31 and the light receiving element 32 can be provided in a region other than the connector 10. For this reason, the technical restrictions by the connector 10 decrease. Moreover, since the light receiving unit 33 and the light receiving element 32 that receive the light that has passed through the identification mark 160 are optically connected by the light guide path 34, the light emitting element 31 and the light receiving element 32 can be mounted on the same substrate surface, The complication of the manufacturing process is prevented.

  Then, after taking out the biosensor 100, the measuring instrument 1 receives light from the light emitting element 31, determines from the received light amount whether or not the light emitting amount of the light emitting element 31 is normal, and determines the defect of the light emitting element 31. An abnormality detecting unit 60 for detecting is provided. For this reason, erroneous selection of calibration data due to insufficient light emission is prevented, and erroneous measurement values are prevented from being displayed.

  In the present invention, the light emitting element 31 that is stored in the position storage area 62 and serves as a determination reference is selected from the light emitting elements 31 at any position as long as the light from the light emitting element 31 is received by the corresponding identification mark 160. Is done. For example, in the above example, the light emission amount of the light emitting element D corresponding to the position D cannot be used as a reference. Further, in the present invention, the state in which the light emitting element 31 emits normally means that the light emission amount of the light emitting element 31 serving as a reference is larger than the light emission amount of the light emitting element 31 that is determined by comparison with the light emission amount of the light emitting element 31 serving as a reference. This means that the function of the light emitting element 31 may be lower than the initial stage. That is, the abnormality detection unit 60 confirms a light emission amount that can correctly determine whether the identification mark 160 is present.

  However, in the present invention, as an alternative to the position storage area 62 for storing the position information of the light emitting element 31 received by the light receiving element 32, a reference value storage area (not shown) is provided with the reference light emission amount as an absolute value. The reference light emission amount stored in the reference value storage area and the light emission amount of each light emitting element 31 may be compared. In this case, the biosensor 100 having no through hole 160 can be used. That is, the detection unit 30 does not detect the ON signal, but can confirm that all the light emitting elements 31 are normal, and therefore, calibration data corresponding to the OFF, OFF, OFF, OFF bit patterns can be used. In this case, the measured value can be calculated without calibration.

  However, in this method, even if the calibration data is correctly identified, if the light emission amount of the light emitting element 31 is lower than the reference light emission amount, the abnormality detection unit 60 determines that the light emission is not normal, An error will be displayed. However, as described above, if the light emission amount of the light emitting element 31 received by the light receiving element 32 is used as a reference value, the calibration data is correctly selected regardless of whether the light emission amount is reduced or not, and the measured value is correctly calibrated. It can be said that this is a more preferable embodiment.

  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 the individual light receiving elements 32 are arranged in a one-to-one relationship with each light emitting element 31, or an array It is also possible to arrange a light receiving array in which the light receiving elements are arranged and the position information received can be detected. 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. However, in this case, if the light emitting elements 31 are close to each other, the light receiving element 32 corresponding to the position where the identification mark 160 is not formed may receive light and misidentify the identification information. It is advisable to take preventive measures to avoid misrecognition, such as setting an offset that is detected as ON. In addition, the light emission wavelength of the light emitting element 31 and the light receiving wavelength of the light receiving element 32 corresponding to the light emitting element 31 can be made different from each other to prevent misidentification.

  FIG. 7 is a schematic cross-sectional view in which a biosensor measuring instrument 1 which is still another embodiment of the present invention is partially broken. The light emitting element 31 and the light receiving unit 33 of the measuring instrument 1 are provided in the connector 10, and the light receiving unit 33 and the light receiving element 32 on the circuit board 3 are optically connected by a light guide path 34.

  FIG. 8 is a perspective view showing an example of the biosensor 100 used in the measuring instrument 1 shown in FIG. The biosensor 100 includes an identification mark 160 in a marker forming region 151 between two terminals 112 provided in the connector mounting portion 150. The presence or absence of the identification mark 160 is detected by optical means by using two types of identification marks 160 having different optical characteristics. For example, the illustrated biosensor 100 includes two types of identification marks 160, which are a light-transmitting identification mark 160a and a light-low-transmitting identification mark 160b. In this case, (1) when the transmittance is low, “marked” is determined, and when the transmittance is high, “not marked”, or (2) when the transmittance is high, “marked”, the transmittance is It can be judged that there is no mark when it is low, and the two are distinguished by the difference in transparency. The difference in transparency can be distinguished by the electromotive voltage generated by the light receiving element 32.

  In many cases, the biosensor 100 uses a substrate 110 having high light transmittance. For this purpose, for example, an identification mark 160b having a low light transmission property by application of a material having a low light transmission property, such as a conductive film containing ink, a seal, gold, copper, carbon or the like, preferably a light non-transparent material. Is formed. That is, the low-light-transmitting identification mark 160b is formed by applying such low-light-transmitting ink or the like, and the light-transmitting mark 160a is formed by not performing these coatings. Therefore, if it can be recognized that light is transmitted through the substrate 110 and there is no low light-transmitting identification mark 160b, it can be determined that the light-transmitting mark 160a is formed. The identification information is constituted by the two types of identification marks 160 formed in this way, and the detection unit 30 is a bit that is output ON and OFF from the combination of the light transmissive mark 161a and the light transmissive mark 161b. Get a pattern.

  In the illustrated biosensor 100, the light-transmitting identification mark 160 a is formed by removing a necessary region of the low-light-transmitting film 152 formed in the marker forming region 151 by a method such as peeling, punching, or cutting. Is formed. Then, the region where the low-light-transmitting film 152 remains without being removed is recognized as the low-light-transmitting identification mark 160b (indicated by a broken-line square frame in the drawing). In particular, since the terminal 112 is formed on the connector mounting portion 150 of the biosensor 100 by applying a conductive paste or the like, a film 152 having a low light transmittance can be formed simultaneously with the formation of the terminal 112. Further, since the light-transmitting identification mark 160 is provided by removing a predetermined region of the film 152, the process is not complicated, which is very convenient. In addition, since light transmittance is used, the formation accuracy of the film 152 and the removal accuracy of the film 152 may be slightly deteriorated.

  However, the light receiving element 32 may also be provided in the connector 10. As described above, the measuring instrument 1 of the present invention can also include the light emitting element 31 and the light receiving element 32 that detect the presence or absence of the identification mark 160 in the connector 10. Since the measuring device 1 can also recognize the identification information in a non-contact state with the biosensor 100, it is possible to avoid the identification failure accompanying the contact failure.

  FIG. 9 is a schematic cross-sectional view in which a biosensor measuring instrument 1 which is still another embodiment of the present invention is partially broken. The light emitting element 31 and the light receiving element 32 are arranged on the same substrate surface of the circuit board 3. The light emitting element 31 emits light toward the identification mark 160 formed on the back surface of the biosensor 100, and the light receiving element 32 receives the light reflected by the identification mark 160.

  FIG. 10 is a rear view of the biosensor 100 used in the measuring instrument 1. In this biosensor 100, an identification mark 160 is formed in a marker forming region 151 provided on the back surface of the substrate 110. The identification mark 160 includes three light reflective identification marks 160c having high light reflectivity and one low light reflective identification mark 160d having low light reflectivity. The light-reflective identification mark 160c can be formed, for example, by applying a light-reflective substance or sticking a seal. The area where the substance is not applied or the sticker is not applied is recognized as a light low-reflectivity mark 161d (indicated by a broken-line square frame in the figure).

  The light emitted from the light emitting element 31 is reflected by the light reflective identification mark 160c, received by the light receiving element 32, and converted into an electrical signal. In this way, the detection unit 30 recognizes the electrical signal output from the light receiving element 32 as a bit pattern and determines necessary calibration data.

  Also in this measuring instrument 1, the same number of light emitting elements 31 and light receiving elements 32 as the maximum number of identification marks 160 are arranged, and the same number of light emitting elements 31 and one light receiving element 32 as the maximum number of identification marks 160 are arranged. A configuration in which the light emitting elements 31 are caused to emit light sequentially at time intervals is employed. Then, after the biosensor 100 is taken out, the light emitting element 31 can emit light again and an abnormality of the light emitting element 31 can be detected.

  Further, although not shown in the figure, like the biosensor 100 shown in FIG. 8, a label formation region 151 made of a light-reflective film is prepared on the back surface of the biosensor 100, and a predetermined region of the region 151 is deleted. By doing so, the low-light reflective identification mark 150b may be formed.

  As described above, the measuring instrument 1 of the present invention can detect the presence or absence of the identification mark 160 using light reflectivity and identify data necessary for calibration. In particular, the cover 120 region of the biosensor 100 can hardly be expected to be transmissive because the conductor path 113 is present, but is wider than the connector mounting portion 150. Accordingly, identification marks 160 made up of a large number of through-holes and light-reflecting identification marks 160a can be formed in this region, and more calibration data can be handled.

  Moreover, as long as the biosensor measuring device 1 detects the presence / absence of the identification mark 160 using the light emitted from the plurality of light emitting elements 31, the measuring device 1 of any aspect can include the abnormality detecting unit 60, It is possible to prevent erroneous display due to a defect in the light emitting element 31 or a decrease in power supply voltage.

It is the schematic sectional drawing which fractured partially the biosensor measuring device of the present invention. It is a block diagram which shows the structure of the measuring device of FIG. It is a flowchart which shows the measurement procedure in the measuring device 1 of FIG. It is a schematic perspective view which shows an example of the biosensor used for the measuring device of FIG. It is a disassembled perspective view of the biosensor of FIG. It is explanatory drawing which shows the detection method of the identification mark of a biosensor, Comprising: (a) is a figure which shows the position of an identification mark, (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. It is the schematic sectional drawing which fractured | ruptured partially the biosensor measuring device which is another embodiment of this invention. It is a schematic perspective view which shows an example of the biosensor used for the measuring device of FIG. It is the schematic sectional drawing which fractured | ruptured partially the biosensor measuring device which is another embodiment of this invention. It is a rear view which shows an example of the biosensor used for the measuring device same as the above.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Measuring instrument 2 Case 3 Circuit board 10 Connector 30 Detection part 31 Light emitting element 32 Light receiving element 40 Collation part 50 Operation part 60 Abnormality detection part 63 Light emission amount comparison part 100 Biosensor 110 Board | substrate 112 Terminal 113 Conductor path 120 Cover 150 Connector installation Part 160 Identification mark 160a Light transmission identification mark 160b Light low transmission identification mark 160c Light reflection identification mark 160d Light low reflection identification mark

Claims (10)

A biosensor measuring device that measures using a biosensor with a mark that can be identified by optical means.
A maximum number of light-emitting elements of a mark necessary for biosensor identification, and 1 to the maximum number of light-receiving elements that receive light from the light-emitting elements;
After the measurement is completed, after the biosensor is confirmed to be taken out, the light from the light emitting element is received, and it is judged whether the light emission amount of the light emitting element is normal or not based on the amount of received light. After that, a biosensor measuring instrument comprising an abnormality detecting unit that determines whether or not the measured value can be displayed on the extracted biosensor .   The abnormality detection unit compares the amount of light received from each light-emitting element with reference to the amount of light received from the light-emitting element corresponding to the mark that has been detected in the absence of a biosensor. 1. The biosensor measuring instrument according to 1.   The biosensor measuring device according to claim 1 or 2, wherein the light emitting element and the light receiving element are arranged in a one-to-one relationship. A mounting substrate on which the light emitting element and the light receiving element are mounted on the same surface;
A light receiving portion disposed so as to be able to receive light that has passed or passed through the mark;
The biosensor measuring device according to claim 1, further comprising a light guide that guides light received by the light receiving unit to the light receiving element. A single light receiving unit that receives light from the plurality of light emitting elements;
One light receiving element;
The biosensor measuring device according to claim 4, comprising one light guide path.   The biosensor measuring device according to any one of claims 1 to 5, wherein the light emitting wavelengths of the plurality of light emitting elements are different from each other.   The biosensor measuring device according to claim 5, further comprising a control unit that causes the light emitting element to emit light at regular time intervals. A mounting substrate on which the light emitting element and the light receiving element are mounted on the same surface;
A light emitting unit that emits light emitted from the light emitting element toward the mark;
The biosensor measuring device according to any one of claims 1 to 3, further comprising a light guide that guides light emitted from the light emitting element to a light emitting unit.   A light receiving element or a light receiving portion that receives light emitted from the light emitting element and the light emitting element, or a connector forming region in which a light emitting element or light emitting portion that emits light toward the light receiving element and the light receiving element is attached to a biosensor. The biosensor measuring device according to claim 1, wherein the biosensor measuring device is provided in addition to the above. A biosensor with a mark that can be identified by optical means, a maximum number of light-emitting elements required for biosensor identification, and 1 to the maximum number of light-receiving elements that receive light from the light-emitting element A biosensor system that performs measurement using a biosensor measuring device including an element,
After the measurement is completed, after the biosensor is confirmed to be taken out, the light from the light emitting element is received, and it is judged whether the light emission amount of the light emitting element is normal or not based on the amount of received light. Then, a biosensor system comprising an abnormality detection unit that determines whether or not the measured value can be displayed in the extracted biosensor.

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