JP2009008574A - Sensor chip, biosensor cartridge, and biosensor device - Google Patents

Abstract

PROBLEM TO BE SOLVED: To eliminate the need for a product code input operation and a circuit chip insertion operation when a sensor chip is used, simplify measurement and improve the reliability of measurement results.
A sensor that provides a reagent that reacts with a specific component in a sample on an insulating substrate, and detects a specific component by detecting electrical characteristics of the reagent with detection electrodes 41 and 43 provided on the insulating substrate. An identification pattern 51 which is a chip 100 and has chip information and can be discriminated by a measuring apparatus is provided on the insulating substrate 47. The identification pattern 51 includes a plurality of conductive marks, and specifies calibration information by a combination according to the presence or absence of conductive marks at a plurality of specific positions set in a predetermined area. The identification pattern 51 is preferably provided on the opposite side of the detection electrodes 41 and 43 with the insulating substrate 47 interposed therebetween. Further, the identification pattern 51 can be provided by printing on a sticker having an adhesive layer and sticking this sticker on the insulating substrate 47.
[Selection] Figure 1

Description

  The present invention relates to a sensor chip, a biosensor cartridge, and a biosensor device that measure the amount of a specific component such as glucose in blood collected by puncturing a fingertip or the like.

  In recent years, in order to detect diabetes early and prevent its deterioration, self blood glucose measurement for monitoring fluctuations in daily blood glucose levels has been recommended. A lancet, a sensor chip, and a measuring device are used for self blood glucose measurement. Since the self blood glucose measurement may be performed a plurality of times a day, it is desirable that the measurement can be easily performed. FIG. 6 is a configuration diagram in which an external perspective view of a sensor integrated with a lancet described in Patent Document 1 is shown in (a), and an exploded perspective view is shown in (b). The lancet-integrated sensor 11 includes a sensor chip (chip body) 13, a lancet 15, and a protective cover 17. The chip body 13 has a cover 19 and a substrate 21 that can be opened and closed. An internal space 23 is formed on the inner surface of the cover 19. The internal space 23 accommodates the lancet 15 so as to be movable.

  A puncture device (needle) 25 provided at the tip of the lancet 15 can be projected and retracted from an opening 27 formed at the front end of the internal space 23 of the tip body 13 as the lancet 15 moves. . The shape of the internal space 23 is curved so that the width of the inner space 23 is slightly narrower than that of the lancet 15 at the end where the protrusion 29 is located, and the lancet 15 is locked to the chip body 13 by mutual pressing force and frictional force. It is like that. The protective cover 17 has a tube portion 31 into which the needle 25 is inserted, and the tube portion 31 can be accommodated inside the chip body 13 as the needle 25 moves. In a state before use, the protective cover 17 is covered with the needle 25 to protect it, so that the user is not accidentally injured. The substrate 21 is provided with a pair of electrode terminals 33, which can be electrically connected to measuring means of a measuring device (not shown).

The lancet-integrated sensor 11 configured as described above removes the protective cover 17 and pushes the lancet 15 to protrude the needle 25 from the tip body 13 when in use. After puncturing the subject in this state, the needle 25 is housed inside the chip body 13 and the opening 27 provided at the front end is brought close to the puncture port of the subject to collect the outflowed blood.
International Publication No. 02/056769 Pamphlet

By the way, the sensor chip may vary among manufacturing lots. Such variations include, for example, variations in electrical resistance of detection electrodes, variations in reagent application, and the like. Such variations in the sensor chip affect, for example, a calibration curve (blood glucose level conversion formula based on a measuring machine detection current value) when measuring a blood glucose level. For this reason, a manufacturing code is specified in a commercially available sensor chip, and it is necessary for the measurer to manually input the manufacturing code when using the sensor chip. For example, in the case where the manufacturing code is displayed on the product case, the variation of the chip characteristic value is calibrated when the user inputs the product code to the measuring device. In addition, there is a product that is calibrated by inserting a circuit chip (recording calibration curve information) bundled with a sensor chip into a measuring device at the start of use.
However, these product code input operations and circuit chip insertion operations are laborious and often forgotten, and as a result, erroneous measurement results may be shown.
The present invention has been made in view of the above circumstances, and provides a sensor chip, a biosensor cartridge, and a biosensor device that do not require a product code input operation and a circuit chip insertion operation and are laborious, thereby simplifying measurement, and The purpose is to improve the reliability of measurement results.

The above object of the present invention is achieved by the following configuration.
(1) An insulating substrate, a detection electrode provided on one surface of the insulating substrate, and a reagent that is provided on the insulating substrate and reacts with a specific component in a sample. A sensor chip for measuring the specific component by detecting electrical characteristics of
A sensor chip in which an identification pattern having chip information corresponding to each chip and made distinguishable by a measuring device is provided on the insulating substrate.

  According to this sensor chip, chip information is detected by discriminating an identification pattern by the measuring device through the detection electrode, and the electrical characteristics of the detected reagent are automatically calibrated based on this chip information, which is conventionally performed. The input operation of the product code and the operation of inserting the circuit chip for calibrating the variation in the electrical resistance of the detection electrode and the variation in the application of the reagent are no longer necessary.

(2) The sensor chip according to (1), wherein the identification pattern includes a plurality of conductive marks, and the chip information is specified by a combination based on presence or absence of the conductive marks at a plurality of specific positions set in a predetermined region.

  According to this sensor chip, the conductive mark can be formed in a simple shape, which can be easily formed by printing, etc., and the discrimination means is simpler than that which optically discriminates the line width (barcode) etc. it can.

(3) The sensor chip according to (1) or (2), wherein the identification pattern is provided on the opposite side of the detection electrode with the insulating substrate interposed therebetween.

  According to this sensor chip, one chip connection connector can be used, and for example, the upper side of the electrical contacts arranged in a pair in the connector can be assigned the upper side as the sensor chip contact and the lower side as the discrimination contact. With a simple modification, an identification pattern discrimination function (auto coding function) can be added.

(4) The sensor chip according to (3), wherein the identification pattern is printed on a seal having an adhesive layer, and the seal is attached to the insulating substrate.

  According to this sensor chip, a plurality of seals of the same conductive mark are printed in a roll for each sensor chip production lot, that is, for each chip information, and this seal roll is made to correspond to the production lot and separated from the seal roll. By sticking the sticker to the sensor chip of the same production lot, mass productivity can be improved.

(5) The sensor chip according to (3), wherein the identification pattern is printed on the insulating substrate.

  According to this sensor chip, an identification pattern having chip information corresponding to each individual manufacturing chip can be directly printed on the insulating substrate, and the chip information can be printed with a fine response taking into account variations within the manufacturing lot and with fewer steps. Can be granted.

(6) any one sensor chip of (1) to (5);
A puncture device having a puncture device protruding at the tip;
A biosensor cartridge comprising: a receiving member that sandwiches the sensor chip with the puncture device.

  According to this biosensor cartridge, the puncture device is integrally provided, and puncture, reaction between the sample and the reagent, and automatic calibration of electrical characteristics based on the reaction can be performed in a series of operations.

(7) The biosensor cartridge of (6) is loaded,
A biosensor device comprising a measuring device connected to the detection electrode of the loaded biosensor cartridge to obtain information on the specific component.

  According to this biosensor device, puncturing, detection of a specific component, and calibration of electrical characteristics can be performed automatically, eliminating the need for product code input operations and circuit chip insertion operations.

  According to the sensor chip of the present invention, a reagent that reacts with a specific component in a sample is provided, and the sensor chip that measures the specific component by detecting the electrical characteristics of the reagent with the detection electrode has the chip information and is measured. Since the identification pattern that can be discriminated by the device is provided, the input operation of the product code and the insertion operation of the circuit chip are not required, so that the measurement is simplified and the reliability of the measurement result is improved. be able to.

  According to the biosensor cartridge of the present invention, the sensor chip is sandwiched between the sensor chip according to any one of claims 1 to 5, a puncture device having a puncture device projecting from the tip, and the puncture device. In addition to the effects produced by the sensor chip, the puncture and the detection of the specific component can be performed simultaneously, and the measurement can be further simplified.

  According to the biosensor device of the present invention, the biosensor cartridge according to claim 6 is loaded, and the measuring device is connected to the detection electrode of the loaded biosensor cartridge to obtain information on the specific component. Detection of specific components and calibration of electrical characteristics can be performed automatically, and highly reliable measurement results can be obtained by simple measurement that eliminates the need for product code input operations and circuit chip insertion operations.

DESCRIPTION OF EMBODIMENTS Hereinafter, preferred embodiments of a sensor chip, a biosensor cartridge, and a biosensor device according to the present invention will be described with reference to the drawings.
FIG. 1 is a schematic view showing a sensor chip according to the present invention in a top view (a), a bottom view (b), a rear front view (c), and a connected side view (d).
In the sensor chip 100 according to this embodiment, a reagent that reacts with a specific component in a sample (for example, blood) is provided, and the electrical characteristics of the reagent are detected by the detection electrodes 41 and 43. A terminal 55 of a measuring device (not shown) is electrically connected to the detection electrodes 41 and 43. The measuring device measures a specific component by inputting the current generated by the reaction between the sample and the reagent to the measuring means.

  The sensor chip 100 is formed by laminating two insulating substrates (hereinafter also simply referred to as “substrates”) 45 and 47 facing each other and a spacer layer 49 sandwiched between the substrates 45 and 47. Detection electrodes 41 and 43 are provided on the surface of at least one substrate 47 of the two substrates 45 and 47 on the side of the spacer layer. Are bent and spaced apart. In the sensor chip 100, a hollow reaction portion (not shown) is formed by the two substrates 45 and 47 and the spacer layer 49 over the portion where the two detection electrodes 41 and 43 are opposed to each other. A sample collection port for introducing blood as a sample collected by puncture is provided at the tip of the hollow reaction part.

  The detection electrodes 41 and 43 are exposed in the hollow reaction part, and, for example, an enzyme and a mediator are immobilized immediately above or in the vicinity of the detection electrodes 41 and 43 in the hollow reaction part to generate a current by reacting with glucose in the blood. Reagents are provided. In other words, the hollow reaction part is a part where a sample such as blood collected from the sample collection port undergoes a biochemical reaction with the reagent.

  As the material of the substrates 45 and 47 and the spacer layer 49, an insulating material film is selected. As the insulating material, ceramics, glass, paper, biodegradable material (for example, polylactic acid microbial production polyester), poly Examples thereof include thermoplastic resins such as vinyl chloride, polypropylene, polystyrene, polycarbonate, acrylic resin, polybutylene terephthalate and polyethylene terephthalate (PET), thermosetting resins such as epoxy resins, and plastic materials such as UV curable resins. A plastic material such as polyethylene terephthalate is preferable because of its mechanical strength, flexibility, and ease of chip fabrication and processing. Typical PET resins include Melinex and Tetron (trade names, manufactured by Teijin DuPont Films, Inc.), Lumirror (trade names, manufactured by Toray Industries, Inc.), and the like.

  Examples of the reagent include glucose oxidase (GOD). In consideration of the blood sampling burden of the specimen, the volume of the hollow reaction part is preferably 1 μL (microliter) or less, particularly preferably 300 nL (nanoliter) or less. With such a small hollow reaction part, it is possible to collect a sufficient blood volume of the specimen even if the diameter of the puncture device is small.

  An identification pattern 51 is provided on the opposite side of the detection electrodes 41 and 43 with the substrate 47 as an insulating substrate interposed therebetween. The identification pattern 51 has chip information unique to the sensor chip to which the identification pattern 51 is attached. This chip information includes at least electrical characteristic calibration information obtained from the detection electrodes 41 and 43. Examples of other chip information include manufacturing lot information (manufacturing date, manufacturing number, etc.), reagent type, electrode material, electrode resistance value, and the like. This chip information can be discriminated by the continuity detector 53 of the measuring device. That is, when the identification pattern 51 is discriminated by the measurement device, for example, a calibration value of electrical characteristics, which is chip information detected via the detection electrodes 41 and 43, is read into the measurement device, and the measurement device uses the electric charge of the reagent. The characteristics are automatically calibrated. As a result, the sensor chip 100 does not require the input operation of the product code and the insertion operation of the circuit chip for calibrating the variation of the electrical resistance of the detection electrodes 41 and 43 and the variation of the reagent application, which are conventionally performed. Yes.

  Further, the sensor chip 100 is provided with an identification pattern 51 on the opposite side of the detection electrodes 41 and 43 with the substrate 47 interposed therebetween, so that a single chip connection connector (not shown) is used and a pair of upper and lower sides are arranged in the connector. For example, the upper side can be assigned to the sensor chip contact (terminal 55) and the lower side can be assigned to the discrimination contacts 57a and 57b, and an identification pattern discrimination function (auto coding function) can be added by a simple modification of the existing structure. can do. In the figure, reference numeral 57 denotes an insulating layer interposed between the discrimination contacts 57a and 57b.

FIG. 2 is an explanatory view showing patterns of conductive marks (a) to (d).
The identification pattern 51 includes, for example, a plurality (five in the illustrated example) of conductive marks 61a, 61b, 61c, 61d, 61e having the same shape, and a plurality of specific positions 65a, 65b, 65c set in the predetermined area 63. , 65d, 65e, the calibration information is specified by the combination of the presence or absence of the conductive marks 61a, 61b, 61c, 61d, 61e. If the pattern of FIG. 2 (a) is expressed in binary, it is 00000, the same (b) is 10101, the same (c) is 00111, the same (d) is 11111, and the code can be divided into 32 ways, which is the fifth power of 2. It becomes. In addition, the identification pattern 51 can be formed by the conductive marks 61a, 61b, 61c, 61d, and 61e having the same shape and a simple shape (square, circle, triangle, etc.), which can be easily formed by printing or the like, and also has a discrimination means. Compared to optically discriminating line width (barcode) etc., it can be made simpler (contact terminal etc.). Of course, the identification patterns 51 may have different shapes.

FIG. 3 is an explanatory view showing a bottom view of a plurality of sensor chips each having an individual seal attached thereto using a seal roll, and (b) showing a bottom view of a sensor chip on which conductive marks are printed. is there.
As shown in FIG. 3A, the identification pattern 51 may be printed on a seal 67 having an adhesive layer, and the seal 67 may be attached to the lower surface of the substrate 47. A plurality of seals 67 of the same conductive mark 61a, 61b, 61c, 61d, 61e are printed in a roll shape for each manufacturing lot of the sensor chip 100, that is, for each calibration information of electrical characteristics, and this seal roll 69 corresponds to the manufacturing lot. Then, by sticking the seal 67 separated from the seal roll 69 to the sensor chip 100 of the same production lot, mass productivity can be improved.

  Further, the identification pattern 51 may be a mark 71 printed directly on the lower surface of the substrate 47 as shown in FIG. Thus, according to the mark 71 printed directly on the substrate 47, the identification pattern 51 having the calibration information corresponding to each individual manufacturing chip can be directly written on the substrate 47, and the calibration information is stored in the manufacturing lot. It can be applied in a small number of steps, with a fine response that takes into account variations. Furthermore, the chip information is magnetically recorded in a recording area formed by applying magnetic paint on paper, and the recording is formed by sticking this paper or directly applying magnetic paint on the surface of PET (polyethylene terephthalate) or the like. The manufacturing cost can also be reduced by magnetically recording the chip information in the region or by magnetically recording the chip information on the magnetized film and attaching this film.

  Therefore, according to this sensor chip 100, a reagent that reacts with a specific component in the sample is provided, and at least the electrical component in the sensor chip 100 that detects the specific component by detecting the electrical characteristics of the reagent with the detection electrodes 41 and 43 is at least electrically Since the identification pattern 51 having the chip information including the calibration information of the characteristics and capable of being discriminated by the measuring apparatus is provided, the input operation of the product code and the insertion operation of the circuit chip are not required, and the measurement is not required. This simplifies and improves the reliability of measurement results.

FIG. 4 is a schematic view showing the biosensor cartridge in a top view (a), a bottom view (b), a rear front view (c), and a connected side view (d).
The sensor chip 100 can constitute the biosensor cartridge 200 by being integrated with the puncture device. The biosensor cartridge 200 includes a puncture device 85 with a puncture device 83 protruding from the tip, a sensor chip 100 attached to the puncture device 85, and a receiving member that holds the sensor chip 100 between the puncture device 83. 87. Examples of the puncture device 83 include a needle, a lancet needle, a cannula, and the like.

  The puncture device 85 is formed by projecting a puncture device 83 in the axial direction at the front end in the axial direction of a substantially semi-cylindrical main body made of a synthetic resin material, for example. The receiving member 87 is made of a synthetic resin material and is formed in a substantially semi-cylindrical shape that forms a substantially cylindrical body with the puncture device 85. The opposing surfaces of both the puncture device 85 and the receiving member 87 are formed as flat surfaces, and the sensor chip 100 is sandwiched between the flat surfaces to form a biosensor cartridge 200 having a substantially cylindrical shape. The biosensor cartridge 200 may have a laminated plate structure in which each of the puncture tool 85, the sensor chip 100, and the receiving member 87 is formed in a plate shape and these are stacked.

  The receiving member 87 can be used as a support that supports the puncture tool 85 and the sensor chip 100. Further, the receiving member 87 may form an attachment portion for an elastic body (not shown) provided at the tip of the biosensor cartridge 200. The elastic body is provided at the tip of the biosensor cartridge 200, and is elastically compressed and deformed at the time of puncturing to relatively project the puncture device 83 inserted therein. Furthermore, the receiving member 87 may form a ventilation path when the biosensor cartridge 200 is used under reduced pressure.

  The identification pattern 51 shown in FIG. 4 is disposed on the rear end surface of the receiving member 87. Since the identification pattern 51 is provided on the rear end surface of the biosensor cartridge 200, the biosensor cartridge 200 is inserted from the rear end, or the electrical contacts of the discrimination contacts 57a and 57b in the biosensor device that pushes out the rear end of the biosensor cartridge 200. The contact property can be improved.

  According to the biosensor cartridge 200, the sensor chip 100, the puncture device 85 having the puncture device 83 projecting from the tip thereof, and the receiving member 87 for holding the sensor chip 100 by the puncture device 85 are provided. In addition to the effect produced by the chip 100, the puncture and the detection of the specific component can be performed at the same time, and the measurement can be simplified.

FIG. 5 is a schematic configuration diagram of the biosensor device.
The biosensor cartridge 200 is loaded into the biosensor device 300 and driven out.
The biosensor device 300 includes a measuring device 91 that obtains information on blood collected by connecting to the detection electrodes 41 and 43 and the identification pattern 51 of the loaded biosensor cartridge 200 and calibration information, and a loaded biosensor cartridge 200. A protective cap 93 is provided for protection.

  The measuring device 91 includes a power source 95, a control device 97, a terminal insertion unit 99, and a display unit 101, which are connected to each other. In the terminal insertion portion 99, the rear end portion of the sensor chip 100 of the biosensor cartridge 200 is inserted to fix and hold the biosensor cartridge 200, and the detection electrodes 41, 43 exposed at the rear end portion of the sensor chip 100, The identification pattern 51 is electrically connected.

  According to this biosensor device 300, the biosensor cartridge 200 is loaded and connected to the detection electrodes 41 and 43 of the loaded biosensor cartridge 200 to obtain information on specific components, and chip information obtained from the identification pattern 51 is obtained. Since the measuring device 91 for calibrating the detected electrical characteristics is provided, puncture, detection of specific components, and calibration of electrical characteristics can be performed automatically, and simple measurement that eliminates the need for product code input operations and circuit chip insertion operations. Thus, a highly reliable measurement result can be obtained.

It is the schematic diagram which represented (a), the bottom view (b), the rear part front view (c), and the connection state side view (d). It is explanatory drawing which represented the pattern example of the conductive mark by (a)-(d). It is explanatory drawing which represented the lower surface view of the several sensor chip on which each piece seal | sticker was stuck using the seal roll to (a), and represented the lower surface view of the sensor chip on which the conductive mark was printed to (b). It is the schematic diagram which represented the top view of the biosensor cartridge in (a), the bottom view (b), the rear front view (c), and the connected side view (d). It is a schematic block diagram of a biosensor apparatus. It is the block diagram which represented the external appearance perspective of the conventional lancet integrated type sensor to (a), and the exploded perspective view to (b).

Explanation of symbols

41, 43 Detecting electrode 47 Insulating substrate 51 Identification pattern 61a, 61b, 61c, 61d, 61e Conductive mark 63 Predetermined area 65a, 65b, 65c, 65d, 65e Specific position 67 Seal 83 Puncture device 85 Puncture tool 87 Receiving member 91 Measuring instrument 100 Sensor chip 200 Biosensor cartridge 300 Biosensor device

Claims (7)

An insulating substrate; a detection electrode provided on one surface of the insulating substrate; and a reagent that is provided on the insulating substrate and reacts with a specific component in a sample. The electrical characteristics of the reagent at the detection electrode A sensor chip for detecting the specific component and measuring the specific component,
A sensor chip in which an identification pattern having chip information corresponding to each chip and made distinguishable by a measuring device is provided on the insulating substrate.   The sensor chip according to claim 1, wherein the identification pattern includes a plurality of conductive marks, and the chip information is specified by a combination according to the presence or absence of the conductive marks at a plurality of specific positions set in a predetermined region.   The sensor chip according to claim 1, wherein the identification pattern is provided on an opposite surface side of the detection electrode with the insulating substrate interposed therebetween.   The sensor chip according to claim 3, wherein the identification pattern is printed on a sticker having an adhesive layer, and the sticker is attached to the insulating substrate.   The sensor chip according to claim 3, wherein the identification pattern is printed on the insulating substrate. The sensor chip according to any one of claims 1 to 5,
A puncture device having a puncture device protruding at the tip;
A biosensor cartridge comprising: a receiving member that sandwiches the sensor chip with the puncture device. A biosensor cartridge according to claim 6 is loaded,
A biosensor device comprising a measuring device connected to the detection electrode of the loaded biosensor cartridge to obtain information on the specific component.

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