WO2013073885A1 - Biocapteur ayant des informations d'identification et appareil pour mesurer celles-ci - Google Patents

Biocapteur ayant des informations d'identification et appareil pour mesurer celles-ci Download PDF

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Publication number
WO2013073885A1
WO2013073885A1 PCT/KR2012/009722 KR2012009722W WO2013073885A1 WO 2013073885 A1 WO2013073885 A1 WO 2013073885A1 KR 2012009722 W KR2012009722 W KR 2012009722W WO 2013073885 A1 WO2013073885 A1 WO 2013073885A1
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WO
WIPO (PCT)
Prior art keywords
biosensor
identification
identifier
housing
shape
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Application number
PCT/KR2012/009722
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English (en)
Korean (ko)
Inventor
이진우
최재규
윤영일
Original Assignee
주식회사 세라젬메디시스
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Publication of WO2013073885A1 publication Critical patent/WO2013073885A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
    • G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
    • G01N27/28—Electrolytic cell components
    • G01N27/30—Electrodes, e.g. test electrodes; Half-cells
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/14—Devices for taking samples of blood ; Measuring characteristics of blood in vivo, e.g. gas concentration within the blood, pH-value of blood
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
    • G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
    • G01N27/28—Electrolytic cell components
    • G01N27/30—Electrodes, e.g. test electrodes; Half-cells
    • G01N27/327—Biochemical electrodes, e.g. electrical or mechanical details for in vitro measurements
    • G01N27/3271—Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood
    • G01N27/3273—Devices therefor, e.g. test element readers, circuitry
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483—Physical analysis of biological material
    • G01N33/487—Physical analysis of biological material of liquid biological material
    • G01N33/4875—Details of handling test elements, e.g. dispensing or storage, not specific to a particular test method
    • G01N33/48771—Coding of information, e.g. calibration data, lot number
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/08—Sensors provided with means for identification, e.g. barcodes or memory chips
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1486—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using enzyme electrodes, e.g. with immobilised oxidase
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/20—Measuring for diagnostic purposes; Identification of persons for measuring urological functions restricted to the evaluation of the urinary system
    • A61B5/207—Sensing devices adapted to collect urine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/43—Detecting, measuring or recording for evaluating the reproductive systems
    • A61B5/4306—Detecting, measuring or recording for evaluating the reproductive systems for evaluating the female reproductive systems, e.g. gynaecological evaluations
    • A61B5/4343—Pregnancy and labour monitoring, e.g. for labour onset detection

Definitions

  • the present invention relates to a biosensor, and more particularly, to a biosensor having identification information and a device for measuring the biosensor.
  • Biosensor refers to a means of obtaining information from a substance to be measured by using a biological element or a similar one.
  • Biosensors that use biomaterials such as blood sugar and ketones as detection elements have excellent sensitivity and specificity of reaction, and are used in a wide range of fields such as medical and pharmaceutical fields, process measurement in the bio industry, environmental measurement, and chemical stability evaluation. .
  • biosensors have been used for diagnosis of various self tests and diseases such as blood glucose measurement, pregnancy diagnosis, urine test and the like.
  • biosensors operating by electrochemical measuring methods are mainly used for the measurement of blood glucose.
  • the target substance in the sample reduces oxygen or an electron transfer medium while oxidizing by the catalytic action of the enzyme.
  • the reduced oxygen or electron transfer medium is oxidized by the voltage of the electrode to induce a change in the electron depending on the concentration of the sample, and to quantify the change in the induced electron to determine the amount of the target material.
  • Biosensors using an electrochemical measurement method may have variations in the area of the electrode or the amount of electrode material, and the measured values may vary for each biosensor due to such deviations. That is, a code is assigned to the biosensor for each production unit to reduce the deviation that may occur for each production unit, and the measurement device may identify the code and perform correction according to the corresponding code.
  • a user directly inputs a code assigned to a biosensor to a measurement device, but the user directly inputs the corresponding code to the measurement device, which causes inconvenience to a user and causes a malfunction due to an incorrectly input code.
  • An object of the present invention for solving the above problems is to provide a biosensor capable of providing identification information for identifying a biosensor to a measuring device.
  • Another object of the present invention for solving the above problems is to provide a measuring device that can recognize the identification information of the biosensor.
  • Biosensor having identification information for achieving the above object is a reactor plate for generating a reaction signal in response to the incoming sample, the housing coupled to the reactor plate to form a sample inlet on one side And at least one identifier that forms an identification shape that can be coupled or detached to the other side of the housing and that can identify the biosensor.
  • the reactor plate may include a working electrode and a reference electrode, and the working electrode and the reference electrode may be coated with a reaction reagent to react with the introduced sample to generate a reaction signal.
  • the housing may have at least one identifier holder that allows the identifiers to be combined or separated.
  • the identifier is combined with a measuring device capable of identifying the biosensor and calculating a measurement result, so that the measuring device can calculate identification information corresponding to the identification shape.
  • the identifier may have protrusions and / or recesses to form an identification shape.
  • the identifier may comprise at least one identification element and form the identification shape by combining or removing the identification elements.
  • the identification shape is generated by generating at least one on / off signal to the measuring device. Allow the measuring device to calculate the information.
  • a measuring device capable of recognizing a biosensor, comprising: a sensor coupling unit capable of identifying a biosensor based on an identification shape formed by at least one identifier included in the biosensor. It provides a measuring device.
  • the sensor coupling portion has at least one connector pin capable of recognizing an identification shape formed by an identifier coupled to the sensor coupling portion, and the at least one connector pin has at least one on / off signal by the identification shape. Can be generated.
  • the measurement device of the biosensor can obtain the identification information for identifying the biosensor.
  • the measuring device has the advantage of identifying the biosensor while consuming less power.
  • FIG. 1 is a perspective view of a biosensor and a measuring device having identification information according to an embodiment of the present invention.
  • FIG. 2 is an exploded perspective view of a biosensor having identification information according to an embodiment of the present invention.
  • 3A and 3B are perspective views of a biosensor having identification information according to an embodiment of the present invention.
  • FIG. 4 is a side view of the biosensor shown in FIG. 3A viewed in the A direction.
  • FIG. 5 is a plan view of both of the reactor plate according to an embodiment of the present invention.
  • FIG. 6 is an exploded perspective view of a biosensor having identification information according to an embodiment of the present invention.
  • FIG. 7 is a perspective view of a biosensor having identification information according to another embodiment of the present invention.
  • FIG. 8 is a perspective view of a biosensor having identification information according to another embodiment of the present invention.
  • FIG. 9 is a conceptual view illustrating a biosensor coupled to a sensor coupling unit according to an embodiment of the present invention.
  • first, second, A, and B may be used to describe various components, but the components should not be limited by the terms. The terms are used only for the purpose of distinguishing one component from another.
  • the first component may be referred to as the second component, and similarly, the second component may also be referred to as the first component.
  • FIG. 1 is a perspective view of a biosensor and a measuring device having identification information according to an embodiment of the present invention.
  • the present invention provides a biosensor 200 having identification information and a measuring device 100 capable of measuring information possessed by the biosensor 200.
  • the biosensor 200 may be combined with the measuring device 100.
  • the biosensor 200 may generate a reaction signal in response to the introduced sample, and the measurement apparatus 100 may measure the reaction signal generated by the biosensor 200.
  • the biosensor 200 has identification information for identifying itself, and the measurement apparatus 100 may recognize or identify the corresponding identification information of the biosensor 200.
  • the measurement apparatus 100 may measure the response signal generated by the biosensor 200 and display the contents according to the measurement result.
  • FIG. 2 is an exploded perspective view of a biosensor having identification information according to an embodiment of the present invention
  • FIGS. 3A and 3B are perspective views of a biosensor having identification information according to an embodiment of the present invention.
  • FIG. 4 is a side view of the biosensor shown in FIG. 3A viewed in the A direction.
  • the biosensor 200 having identification information according to the present invention includes a reactor plate 210, a housing 220, and an identifier 230.
  • 3A and 3B illustrate the shape of the biosensor 200 viewed from the side where the reactor plate 210 is coupled and the shape viewed from the relative side thereof.
  • the reactor plate 210 generates a reaction signal in response to the incoming sample.
  • the reactor plate 210 may be coupled to the housing 220 and form a sample inlet 221 through coupling with the housing 220.
  • the reactor plate 210 may include a reactant (reaction reagent) that reacts with the incoming sample.
  • the housing 220 may have a shape surrounding the reaction surface and both sides of the reactor plate 210, and may be combined with the reactor plate 210 to form a sample inlet 221 on one side.
  • FIG. 5 is a plan view of both of the reactor plate according to an embodiment of the present invention.
  • the reactor plate 210 may include an operation signal transmission electrode 211 and a reference signal transmission electrode 212.
  • the operation signal transmission electrode 211 and the reference signal transmission electrode 212 provided in the reactor plate 210 may be disposed on the front surface of the reactor plate 210 and exposed to the outside.
  • the operation signal transmission electrode 211 and the reference signal transmission electrode 212 may be connected to a switching pin (121 of FIG. 9) to be described later to transmit a reaction signal to the measurement apparatus 100.
  • the reactor plate 210 may include a working electrode 214 and a reference electrode 215 on the rear surface.
  • the working electrode 214 and the reference electrode 215 are electrically connected to the operation signal transmission electrode 211 and the reference signal transmission electrode 212 through a via hole 217 penetrating through the reactor plate 210, respectively. Can be connected.
  • a reaction reagent is coated on the working electrode 214 and the reference electrode 215 to generate a reaction signal by reacting with the sample introduced through the sample inlet 221 of FIG. 4.
  • the housing 220 may have a shape surrounding the reactor plate 210, and the sample inlet 221 may be coupled to one side of the housing plate 210. Can be formed. That is, the housing 220 may have a shape that is coupled to one surface of the reactor plate 210.
  • the identifier 230 may be coupled to a direction in which the housing 220 is coupled with the measurement apparatus 100 of the biosensor 200.
  • the housing 220 may have an identifier holder 222 that allows the identifier 230 to be combined or detached.
  • the identifier holder 222 may have a shape of a groove or a cover to which the identifier 230 having various shapes may be coupled or separated, but the shape of the identifier holder 222 is not particularly limited.
  • the housing 220 may include an air outlet 223 through which air may be discharged on one surface, and may use an insulator that is not electrically sensitive.
  • the identifier 230 forms an identification shape to identify the biosensor 200.
  • the identifier 230 can be coupled to the housing 220.
  • the identifier 230 may be separated in a state of being coupled to the identifier holder 222 provided in the housing 220, or may be combined in a state of separation to form an identification shape for identifying the biosensor 200. That is, the identifier 230 may have various shapes and form an identification shape that is a positional characteristic of the shape.
  • the identifier 230 may be an insulator made of the same material as the housing 220.
  • the identifier 230 may have various identification shapes.
  • the identifier 230 illustrated in FIG. 2 may include a protrusion 230a and a recess 230b, and the identifier 230 may define one protrusion 230a and one recess 230b. It can be provided.
  • the identifier 230 illustrated in FIG. 6 may include a pair of protrusions 230a and a pair of recesses 230b, and the protrusions 230a and the recess 230b may be alternately disposed. .
  • the present invention is not limited thereto, and the two protrusions 230a may be disposed in succession or the two recesses 230b may be disposed in succession.
  • the number of protrusions 230a and the number of recesses 230b may be appropriately adjusted.
  • the user gives identification information about the biosensor 200 by coupling the identifier 230 having a specific identification shape to the housing 220. can do. That is, the identifier 230 may attach or detach the identifier 230 to impart identification information to the biosensor 200.
  • Such Embodiment 1 may be referred to as a 'removable'.
  • the identification shape formed by the identifier 230 may generate at least one on / off signal to the measurement device 100, and the measurement device 100 may generate at least one on / off signal generated by the identification shape. Identification information can be calculated.
  • the measurement apparatus 100 may calculate a binary code through an on / off signal, and use the calculated binary code as identification information of the biosensor 200.
  • FIG. 7 is a perspective view of a biosensor having identification information according to another embodiment of the present invention.
  • the biosensor 200 includes a reactor plate 210, a housing 220, and an identifier 230.
  • the identifier 230 coupled to the housing 220 may specifically include a plurality of identification elements 231, 232, and 233.
  • the user may form a specific identification shape by removing at least one of the identification elements 231, 232, 233 coupled to the housing 220. That is, some of the identification elements 231, 232, and 233 may be removed according to the characteristics of the corresponding biosensor 200 in a state of being coupled to one side of the housing 220 to form an identification shape.
  • a plurality of separation grooves 240 are formed between the identification elements 231, 232, 233 and between the identification elements 231, 232, 233 and the housing 220. can do.
  • the region from which the identification element is removed plays a role similar to that of the recess 230b of the removable biosensor shown in FIGS. 2 and 6, and the identification element not removed is a protrusion of the removable biosensor shown in FIGS. 2 and 6. Similar to 230a).
  • an identifier 230 that already has a specific shape may be combined or separated, whereas in Embodiment 2, at least one of the identification elements 231, 232, 233 is coupled to the housing 220.
  • the identification element once in the state and once removed is not able to couple back to the housing 220.
  • Embodiment 2 as shown in FIG. 7 may be referred to as a 'shape removing type'.
  • FIG. 8 is a perspective view of a biosensor having identification information according to another embodiment of the present invention.
  • the biosensor 200 includes a reactor plate 210, a housing 220, and an identifier 230.
  • the identifier 230 may include a plurality of identification elements 231, 232, and 233. At least one of the identification elements 231, 232, and 233 may be coupled to or separated from the housing 220. Specifically, the user may form an identifier 230 having a specific identification shape by combining or separating some of the identification elements 231, 232, and 233.
  • an area that is located at one side of the housing 220 to enable the housing 220 and the identification elements 231, 232, and 233 to be coupled or separated may be referred to as a coupling area 225.
  • a plurality of coupling regions 225 may exist, and specifically, the coupling region 225 may be formed in a number corresponding to the identification elements 231, 232, and 233.
  • the region where the identification element is not coupled serves a similar role to the recess 230b of the removable biosensor shown in FIGS. 2 and 6, and the combined identification element is a protrusion (not shown) of the removable biosensor shown in FIGS. 2 and 6. Similar to 230a).
  • a user combines or separates one identifier 230 having a specific identification shape into the housing 220, while Embodiment 3 combines or separates some of the identification elements 231, 232, 233. Identification can be made.
  • Such a third embodiment may be referred to as "individual shape removable”.
  • the user can form an identification shape by removing some of the identification elements 231, 232, 233 and cannot recombine the removed identifier 230, while Embodiment 3 is separated. At least some of the identification elements 231, 232, and 233 may be coupled to the housing 220 again. Therefore, the biosensor 200 according to the third embodiment may have higher utilization than the biosensor 200 according to the first or second embodiment.
  • FIG. 9 is a conceptual view illustrating a biosensor coupled to a sensor coupling unit according to an embodiment of the present invention.
  • the biosensor 200 is coupled to the sensor coupling unit 120 provided in the measuring device 100.
  • the sensor coupling unit 120 may be coupled to the base substrate 110 of the measuring device 100. That is, the measurement apparatus 100 may include a sensor coupling unit 120 to calculate a measurement value from the biosensor 200 coupled to the sensor coupling unit 120.
  • the sensor coupling unit 120 includes at least one switching pin 121, specifically, a pair of switching pins 121 and at least one connector pin 123.
  • the switching pins 121 may be connected to the operation signal transmission electrode 211 and the reference signal transmission electrode 212 mounted on the biosensor 200, respectively.
  • the switching pin 121 may apply power to the biosensor 200 and may receive a response signal through the operation signal transmission electrode 211 and the reference signal transmission electrode 212.
  • At least one connector pin 123 of the sensor coupling unit 120 may recognize the identification shape generated by the identifier 230 coupled to the sensor coupling unit 120.
  • the connector pin 123 may correspond to the number of protrusions 230a and recesses 230b of the identifier 230 shown in FIG. 2 or 6 or the identifier shown in FIG. 7 or 8 ( A plurality of identification elements 231, 232, and 233 of 230 may be arranged in plurality.
  • the connector pin 123 may generate at least one on / off signal by the identification shape of the identifier 230, and the measuring device 100 identifies the biosensor 200 through the combination of the on / off signals. Information can be calculated. That is, the biosensor 200 according to the present invention includes a connecting element such as a connector pin 123 or a switch connector, and the connecting element may generate at least one on / off signal according to an identification shape.
  • the present invention provides a measuring device 100 capable of recognizing a biosensor 200 having identification information.
  • the measurement apparatus 100 may include a sensor coupling unit 120 that may identify the biosensor based on an identification shape formed by at least one identifier included in the biosensor 200.
  • the measurement apparatus 100 may calculate identification information for identifying the biosensor 200 from at least one on / off signal.
  • the biosensor 200 is coupled to the sensor coupling unit 120 provided in the measuring device 100.
  • the biosensor 200 provides identification information that can identify itself to the measurement device 100 through an identification shape.
  • the sensor coupling unit 120 may prevent the at least one connector pin 123 from being pressed or pressed based on the specific identification shape formed by the identifier 230 as the biosensor 200 is inserted.
  • the measuring device 100 turns on when the connector pin 123 is pressed while physically contacting the protrusion (230a of FIG. 2 or 6) or the identification elements (231, 232, 233 of FIG. 7 or 8). (on) and the connector pin 123 is disposed in an area without the recess (230b in FIG. 2 or 6) or the identification elements (231, 232, 233 in FIG. 7 or 8) and is not pressed. It may be turned off to generate a code that allows the biosensor 200 to be identified.
  • the on / off signal can be used as a binary code. In other words, the on signal can be set to 1 and the off signal can be set to 0.
  • the identifiers having the combined identification shape of all of the identification elements 231, 232, and 233 are binary codes 111 and the centrally located identification element
  • the identifier having the identification shape when the 232 is removed may be identified by the binary code 101
  • the identifier having the identification shape when the adjacent identification elements 231. 233 are removed may be identified by the binary code 010.
  • the binary code calculated according to the identification shape may indicate the type of the biosensor.
  • 111 may represent a glucose sensor
  • 010 may represent a hemoglobin sensor.
  • Examples 1 to 3 the electrochemical measuring method has been described, but it is apparent to those skilled in the art that the present invention can be applied to other measuring methods, such as an optical measuring method. That is, a biosensor is mounted on the measuring device, and the measuring device can be used in any measuring system for identifying the type or characteristic of the biosensor by the identification shape formed by the identifier. In an optical or immunodiagnostic biosensor, a reaction unit or a reaction zone may be provided instead of the reactor plate. In addition, a reaction labeling means for directly displaying the reaction results may optionally be further included.
  • the biosensor according to the present invention provides a technology for providing the measurement device with identification information capable of identifying the biosensor through the identification shape determined by the identifier.
  • the biosensor having identification information according to the present invention can be manufactured in a small size, it is possible to minimize the power consumption of the measuring device.

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Abstract

L'invention concerne des technologies relatives à un biocapteur ayant des informations d'identification et un appareil pour mesurer celles-ci. Le biocapteur comprend : un substrat de réaction qui réagit à un spécimen introduit pour générer un signal de réaction ; un boîtier couplé au substrat de réaction pour former un orifice d'entrée du spécimen sur un côté de celui-ci ; et au moins un identifiant qui est agencé pour être fixable ou amovible à partir de l'autre côté du boîtier et qui forme un profil d'identification pour identifier le biocapteur. De plus, l'appareil pour mesurer le biocapteur comprend une unité couplée au capteur pour identifier le biocapteur en fonction du profil d'identification généré par au moins un identifiant du biocapteur. Ainsi, le biocapteur peut produire des informations d'identification sur l'appareil pour mesurer le biocapteur de sorte que l'appareil pour mesurer le biocapteur peut identifier le biocapteur même sans une entrée directe d'un utilisateur, et l'appareil pour mesurer le biocapteur peut identifier le biocapteur avec une faible puissance consommée.
PCT/KR2012/009722 2011-11-18 2012-11-16 Biocapteur ayant des informations d'identification et appareil pour mesurer celles-ci WO2013073885A1 (fr)

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KR10-2011-0120759 2011-11-18
KR1020110120759A KR101299795B1 (ko) 2011-11-18 2011-11-18 식별 정보를 가지는 바이오 센서 및 그 측정 장치

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EP3293519A1 (fr) * 2016-09-13 2018-03-14 Bionime Corporation Module de mesure de paramètres physiologiques
CN111044592A (zh) * 2020-01-14 2020-04-21 山东卓越生物技术股份有限公司 传感器模块及其制造方法

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