WO2018222005A1 - Sensor strip and biomaterial measuring device using same - Google Patents

Sensor strip and biomaterial measuring device using same Download PDF

Info

Publication number
WO2018222005A1
WO2018222005A1 PCT/KR2018/006301 KR2018006301W WO2018222005A1 WO 2018222005 A1 WO2018222005 A1 WO 2018222005A1 KR 2018006301 W KR2018006301 W KR 2018006301W WO 2018222005 A1 WO2018222005 A1 WO 2018222005A1
Authority
WO
WIPO (PCT)
Prior art keywords
electrodes
reagent
electrode
blood
hematocrit
Prior art date
Application number
PCT/KR2018/006301
Other languages
French (fr)
Korean (ko)
Inventor
김진구
윤광현
김효정
오인돈
장제영
Original Assignee
주식회사 비바이오
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 주식회사 비바이오 filed Critical 주식회사 비바이오
Publication of WO2018222005A1 publication Critical patent/WO2018222005A1/en

Links

Images

Classifications

    • 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
    • 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
    • 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
    • A61B5/1468—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 chemical or electrochemical methods, e.g. by polarographic means
    • 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
    • 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
    • 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
    • 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
    • G01N33/48707—Physical analysis of biological material of liquid biological material by electrical means
    • G01N33/48721—Investigating individual macromolecules, e.g. by translocation through nanopores
    • 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
    • G01N33/49—Blood

Definitions

  • the present invention relates to a sensor strip for measuring a specific biological material in a biological sample such as blood and a biological material measuring apparatus using the same.
  • a biosensor is a system that converts information from an object to be measured into useful signals that can be recognized, such as color, fluorescence, and electrical signals, using biological elements.
  • useful signals such as color, fluorescence, and electrical signals, using biological elements.
  • the most representative of the biosensors is a blood glucose measurement apparatus for measuring blood glucose in blood.
  • Blood glucose measurement devices generally comprise a sensor strip, a connector, an assay device and a blood collection device. Insert the sensor strip into the inlet of the glucose measuring device, draw a fingertip with a blood collector, and touch the small amount of blood collected at the fingertip with the sensor strip inserted into the glucose measuring device. Your blood glucose reading will be displayed on the screen of your blood sugar measurement device.
  • hematocrit When measuring biomaterials in blood with a biomaterial measuring device such as a blood glucose measuring device, hematocrit (Hct), humidity, temperature, and interference substances affect the measurement results of the biomaterials in the blood, thereby increasing the accuracy of the biomaterial measuring device. Affects. Although temperature is the most significant cause in measuring blood glucose with a blood glucose measurement apparatus, correction of the influence of temperature is performed in most blood glucose measurement apparatuses. Next to temperature, the factor that affects blood glucose measurement results is hematocrit. Hematocrit is a percentage of the volume of red blood cells in the blood. The normal range of hematocrit varies among adults, pregnant women, and newborns.
  • red blood cells act as electrical insulators at a certain range of frequencies to apply alternating current to the blood to measure conductivity, calculate the total amount of red blood cells from the measured conductivity, and calculate the hematocrit to correct the effects of hematocrit.
  • this method takes a long time to calibrate the hematocrit for measuring biomaterials in the blood, and biomaterials other than red blood cells also affect conductivity, and thus have low accuracy.
  • Korean Patent No. 10-0591246 discloses a test strip for an electrochemical biosensor that can effectively compensate for the interference of hematocrit using a blood cell interference correction agent.
  • the patent uses blood cell interference modifiers in combination with components such as reagents applied to test strips.
  • the red blood cells of the blood drawn into the test strip are chemically dissolved to release hemoglobin in the red blood cells to the outside.
  • the released hemoglobin reacts with an electron transporter to transfer electrons, which are then transferred back to the electrode.
  • the hemoglobin-electron transporter causes a current to flow in the electrode proportional to the amount of red blood cells (red blood cell volume) in the blood.
  • the current flowing through the electrode that is, the output current
  • the current flowing through the electrode is the sum of the current through the enzyme-electron transporter reaction and the current through the hemoglobin-electron transporter reaction.
  • the degree of correction depends on the strength of the current generated by the glucose concentration. Therefore, overcorrection occurs at low concentrations of glucose below 70 mg / dL, and inadequate correction occurs at high concentrations of 300 mg / dL or higher glucose. In other words, the glucose concentration at which the correction effect appears is limited.
  • the present invention has been proposed to solve the above problems, by changing the structure of the sensor strip and the arrangement method of the components to correct the interference of the hematocrit to measure a specific biological material in a biological sample such as blood, It is an object of the present invention to provide a sensor strip and a biomaterial measuring apparatus using the same.
  • a sensor strip for measuring a biomaterial in blood may include a first insulating substrate, first and second electrodes spaced apart at predetermined intervals from the first insulating substrate, and the first and second electrodes.
  • a measurement including a first spacer film having a slit formed in at least a portion corresponding to at least a part thereof and installed on the first and second electrodes, and a first reagent applied to at least a portion of the first and second electrodes exposed to the slit A target electrode portion;
  • slits are formed on a second insulating substrate, third and fourth electrodes spaced apart from each other at predetermined intervals on the second insulating substrate, and portions corresponding to at least a portion of the third and fourth electrodes.
  • a hematocrit electrode unit including a second spacer film disposed on an electrode and a second reagent applied to at least a portion of the third and fourth electrodes exposed to the slit of the second spacer film.
  • the measurement target electrode portion and the hematocrit electrode portion are stacked and assembled so that the first reagent of the negative portion and the second reagent of the hematocrit electrode portion face each other at a predetermined interval.
  • the coating thickness of the first reagent of the measurement target electrode portion is smaller than the thickness of the first spacer film, and the coating thickness of the second reagent of the hematocrit electrode portion is smaller than the thickness of the second spacer film.
  • the predetermined interval between two reagents can be formed.
  • the first reagent and the second reagent may react simultaneously with the same blood.
  • the first reagent may be a reagent that reacts with blood glucose in the blood
  • the second reagent may be a reagent that reacts with red blood cells in the blood.
  • the measurement target electrode part and the hematocrit electrode part may have different types of the first and second reagents, and the arrangement position and the overall shape of the electrodes may be the same.
  • a measurement target electrode part including a; And slits are formed on a second insulating substrate, third and fourth electrodes spaced apart from each other at predetermined intervals on the second insulating substrate, and portions corresponding to at least a portion of the third and fourth electrodes. And a hematocrit electrode unit including a second spacer film disposed on an electrode and a second reagent applied to at least a portion of the third and fourth electrodes exposed to the slit of the second spacer film.
  • the measurement target electrode portion and the hematocrit electrode portion are stacked and assembled so that the first reagent of the negative portion and the second reagent of the hematocrit electrode portion face each other at a predetermined interval.
  • the measurement target electrode portion and the hematocrit electrode portion are different in the kind of the first and second reagents, and the arrangement position and the overall shape of the electrodes are the same, and the first and third electrodes are working electrodes, and the second and fourth The electrode may be a reference electrode.
  • the connector includes terminals connected to each of the first to fourth electrodes, the terminal for applying a voltage to the first electrode, a terminal for detecting a current from the second electrode, and a current for detecting the current from the fourth electrode. Terminals may be arranged in order of applying a voltage to the third electrode.
  • the coating thickness of the first reagent of the measurement target electrode portion is smaller than the thickness of the first spacer film, and the coating thickness of the second reagent of the hematocrit electrode portion is smaller than the thickness of the second spacer film.
  • the predetermined interval between two reagents can be formed.
  • the first reagent and the second reagent may react simultaneously with the same blood.
  • the measuring electrode portion and the hematocrit electrode portion of the sensor strip are placed in a face-to-face structure so that the reagents of the measuring electrode portion and the hematocrit electrode portion are not mixed with each other, and a specific biological material such as blood sugar is added to the same blood.
  • the hematocrit can be measured at the same time, reducing the measurement time while improving the accuracy of each measurement result by eliminating the influence between each measurement result. Accordingly, by accurately reflecting and correcting the influence of hematocrit in measuring the concentration of a specific biomaterial such as blood sugar, the accuracy of the measurement result of the concentration of the specific biomaterial is improved.
  • FIG. 1 is a block diagram illustrating a biomaterial measuring apparatus according to an exemplary embodiment of the present invention.
  • FIG. 2 is a view showing the configuration of the electrode to be measured in the sensor strip according to an embodiment of the present invention.
  • FIG 3 is a view showing the configuration of the hematocrit electrode portion of the sensor strip according to an embodiment of the present invention.
  • FIG. 4 is a diagram illustrating a sensor strip in which the electrode to be measured of FIG. 2 and the hematocrit electrode of FIG. 3 are combined.
  • FIG. 5 is a view illustrating a connection structure before coupling of a connector of the biomaterial measuring apparatus and the sensor strip of FIG. 4.
  • FIG. 6 is a diagram illustrating a connection structure after coupling of a connector of the biomaterial measuring apparatus to the sensor strip of FIG. 4.
  • the biomaterial measuring apparatus includes a sensor strip 110, a connector 120, and an analysis device 130.
  • the sensor strip 110 is a means used to analyze a sample such as blood or body fluid collected from a human or animal, and is used for various kinds of biological substances to be measured such as blood glucose level, blood alcohol concentration, and lactic acid concentration of the supplied sample. A corresponding signal can be output.
  • the sensor strip 110 is a strip for measuring blood sugar, and measures a blood sugar of a supplied sample and outputs a signal corresponding thereto.
  • the sensor strip 110 may be a consumable to be replaced at each sample measurement.
  • the sensor strip 110 includes an electrode to be measured for measuring blood sugar and a hematocrit electrode for measuring hematocrit, and the reagent formed on the electrode to be measured and the reagent formed on the hematocrit electrode face to face each other. do. This will be described in detail below.
  • the connector 120 is for connecting the sensor strip 110 with the analysis device 130, and serves as an interface between the sensor strip 110 and the analysis device 130.
  • the connector 120 includes a terminal for applying a voltage to the electrode to be measured of the sensor strip 110, a terminal for detecting a current received from the electrode to be measured, and a terminal for applying a voltage to the hematocrit electrode, and the hematocrit. It may include a terminal for detecting a current received from the electrode unit.
  • the analysis device 130 controls the overall operation of the biomaterial measuring device, applies a voltage to the sensor strip 110 through the connector 120, and analyzes the current received from the sensor strip 110.
  • the concentration of the biological material to be measured is measured.
  • the analysis device 130 may include a computing device, a battery, a memory, and the like.
  • the analysis device 130 measures the blood glucose concentration in the sample based on the current received from the electrode to be measured of the sensor strip 110, and also receives from the hematocrit electrode of the sensor strip 110.
  • the hematocrit in the sample is measured based on the current.
  • the analyzing apparatus 130 corrects the measured blood glucose concentration by using the measured hematocrit, and outputs the corrected blood glucose concentration value.
  • the analyzing apparatus 130 includes a memory, and the blood glucose concentration correction value for each hematocrit measurement value is matched and stored in the memory.
  • the analyzing apparatus 130 reads out the blood sugar concentration correction value corresponding to the measured value of the hematocrit measured using the hematocrit electrode unit from the memory, and reads the blood sugar concentration correction value to the blood sugar concentration value measured using the measurement target electrode unit.
  • the final blood glucose level can be calculated by reflecting this.
  • the analysis device 130 may output the value of the blood sugar level using an LED or the like, or may output the value of the blood sugar level as a digital value through a display means.
  • the electrode 210 to be measured of the sensor strip 110 is a means for measuring a biological material to be measured, such as blood sugar, and includes a lower insulating substrate 211, a spacer film 213, and a lower insulating layer. A working electrode 212a and a reference electrode 212b formed on the substrate 211 are included.
  • the lower insulating substrate 211 may be a glass or inorganic material substrate, a plastic substrate, or a film. In some embodiments, a polyethylene terephthalate (PET), a polycarbonate film, or the like may be used.
  • PET polyethylene terephthalate
  • the pair of electrodes formed on the lower insulating substrate 211, that is, the working electrode 212a and the reference electrode 212b are spaced apart from each other at a predetermined interval and disposed on the lower insulating substrate 211.
  • the working electrode 212a and the reference electrode 212b may be formed of gold or silver as a raw material, or may be manufactured by printing with carbon ink to reduce the manufacturing cost of the product.
  • the working electrode 212a and the reference electrode 212b may be formed by applying a conductive material on the lower insulating substrate 211 and then laser patterning or masking the shape of the electrode.
  • a lower recognition substrate 211 may further include a blood recognition electrode for detecting the inflow of a sample, for example, blood.
  • the spacer film 213 covers the upper surface of the lower insulating substrate 211 on which the working electrode 212a and the reference electrode 212b are formed.
  • the spacer film 213 may be formed in such a manner that an insulating ink is applied to the upper surface of the lower insulating substrate 211 on which the working electrode 212a and the reference electrode 212b are formed to have a predetermined thickness, but is not limited thereto.
  • the spacer film 213 may be another insulating substrate made of the same material as the lower insulating substrate 211.
  • a slit 213a is formed at a portion facing the working electrode 212a and the reference electrode 212b, and the working electrode 212a and the reference electrode 212b are formed through the slit 213a. A portion of is exposed.
  • the measurement reagent 214 is positioned in the slit 213a of the spacer film 213.
  • the measurement reagent 214 is positioned across the working electrode 212a and the reference electrode 212b exposed through the slit 213a.
  • the application thickness of the measurement reagent 214 is smaller than the thickness of the spacer film 213.
  • the reagent 214 may be applied through the slit 213a after covering the spacer film 213 over the electrodes 212a and 212b, or before covering the spacer film 213, corresponding to the area of the slit 213a. It may be applied in advance to the regions of the electrodes 212a and 212b. Meanwhile, the spacer film 213 covers the main portions of the electrodes 212a and 212b and exposes a portion of the electrodes 212a and 212b connected to the terminals of the connector 120 without being covered.
  • Measuring reagent 214 for blood glucose measurement is used as a carrier between the surface of the electrode 212a, 212b and the reagent layer, an electron carrier that can effectively transfer the charge generated by the blood glucose enzyme, biochemical reaction to the surface of the electrode (212a, 212b) It may be configured to include a hydrophilic polymer compound, which is used as a surfactant, a surfactant.
  • the enzyme to be used varies depending on the substance to be detected or needs, and for example, glucose oxidase, glucose dehydrogenase can be used.
  • the hydrophilic polymer compound is necessary to easily fix the reagent 214 on the electrodes 212a and 212b. Examples thereof include cellulose and hydroxyethyl cellulose.
  • the surfactant is such that the reagent 214 is well dispersed on the surfaces of the electrodes 212a and 212b, for example Triton X-100. See US Pat. No. 5,762,770 for specific methods of preparing the reagents, examples of reagents that may be used, and electron transporters. The contents of U.S. Patent No. 5,762,770 are incorporated herein by reference.
  • the hematocrit electrode part 310 of the sensor strip 110 is a means for measuring the volume ratio of red blood cells, that is, hematocrit, in the blood, and includes a lower insulating substrate 311, a spacer film 313, and a lower part.
  • the operation electrode 312a and the reference electrode 312b formed on the insulating substrate 311 are included.
  • the overall shape of the hematocrit electrode part 310 shown in FIG. 3 and the arrangement position of the components are the same as the overall shape of the electrode object 210 to be measured shown in FIG. 2.
  • the lower insulating substrate 311 may be a glass or an inorganic material substrate, a plastic substrate, or a film. In some embodiments, a polyethylene terephthalate (PET), a polycarbonate film, or the like may be used.
  • PET polyethylene terephthalate
  • the pair of electrodes formed on the lower insulating substrate 311, that is, the working electrode 312a and the reference electrode 312b are spaced apart from each other at a predetermined interval and disposed on the lower insulating substrate 311.
  • the working electrode 312a and the reference electrode 312b may be formed of gold or silver as a raw material, or may be formed by printing with carbon ink to reduce the manufacturing cost of the product.
  • the working electrode 312a and the reference electrode 312b may be formed by applying a conductive material on the lower insulating substrate 311 and then laser patterning or masking the shape of the electrode.
  • a lower recognition substrate 311 may further include a blood recognition electrode for detecting the inflow of a sample, for example, blood.
  • the spacer film 313 covers the upper surface of the lower insulating substrate 311 on which the working electrode 312a and the reference electrode 312b are formed.
  • the spacer film 313 may be formed in such a manner that an insulating ink is applied to the upper surface of the lower insulating substrate 311 on which the working electrode 312a and the reference electrode 312b are formed to have a predetermined thickness, but is not limited thereto.
  • the spacer film 313 may be another insulating substrate made of the same material as the lower insulating substrate 311.
  • a slit 313a is formed at a portion facing the working electrode 312a and the reference electrode 312b, and the working electrode 312a and the reference electrode 312b are formed through the slit 313a. A portion of is exposed.
  • a measurement reagent 314 for measuring hematocrit is located in the slit 313a of the spacer film 313.
  • the measurement reagent 314 is positioned across the working electrode 312a and the reference electrode 312b exposed through the slit 313a.
  • the application thickness of the measurement reagent 314 is smaller than the thickness of the spacer film 313.
  • the reagent 314 may be applied through the slit 313a after covering the spacer film 313 over the electrodes 312a and 312b, or corresponding to the area of the slit 313a before covering the spacer film 313. It may be applied in advance to the regions of the electrodes 312a and 312b. Meanwhile, the spacer film 313 covers the main portions of the electrodes 312a and 312b and exposes a portion of the electrodes 312a and 312b connected to the terminals of the connector 120 without being covered.
  • the measurement reagent 314 for hematocrit measurement excludes the enzyme from the blood glucose measurement reagent, and ferricyanide is used as the electron transporter. And blood cell interference compensators. Blood cell interference modifiers are required to hemolyze red blood cells, such as saponins, sodium deoxy cholate, sodium cholate, and the like.
  • FIG. 4 is a diagram illustrating a sensor strip in which the electrode to be measured of FIG. 2 and the hematocrit electrode of FIG. 3 are combined.
  • the sensor strip 110 may be configured such that the measurement reagent 214 of the measurement target electrode part 210 and the measurement reagent 314 of the hematocrit electrode part 310 face each other.
  • 210 and the hematocrit electrode part 310 face each other.
  • the two electrode portions 210 and 310 overlap each other so that the measurement reagent 214 of the measurement target electrode portion 210 and the measurement reagent 314 of the hematocrit electrode portion 310 face each other, and the measurement reagents 214 and 314.
  • the spacer film 213 of the electrode to be measured 210 and the spacer film 213 of the hematocrit electrode 310 may be adhered with an adhesive, a double-sided tape, or the like.
  • FIG. 5 is a view illustrating a connection structure before coupling the connector of the biomaterial measuring device and the sensor strip of FIG. 4
  • FIG. 6 is a view illustrating a connection structure after coupling the connector of the biomaterial measuring device and the sensor strip of FIG. 4. to be. 5 and 6,
  • the connector 120 of the biomaterial measuring apparatus includes a terminal 510a for applying a voltage to the working electrode 212a of the electrode to be measured 210 of the sensor strip 110.
  • a terminal 510b for detecting a current of the reference electrode 212b of the electrode to be measured 210 a terminal 511a for applying a voltage to the working electrode 312a of the hematocrit electrode part 310, and a hematocrit electrode It includes a terminal 511b for detecting the current of the unit 310.
  • the electrode arrangement structure is the same, and the reagents 214 and 314 are stacked and assembled to face each other, the connector 120 5, the terminals 510a for applying a voltage to the working electrode 212a of the electrode to be measured 210 from the left side, and the reference electrode 212b of the electrode to be measured 210 are measured.
  • a voltage is applied to the terminal 510b for detecting the current of the electrode), the terminal 511b for detecting the current of the reference electrode 312b of the hematocrit electrode part 310 and the working electrode 312a of the hematocrit electrode part 310. It is arranged in the order of the terminals 511a.
  • the measurement target electrode portion 210 and the hematocrit electrode portion 310 of the sensor strip 110 have the same overall shape, the arrangement structure of the electrodes, and the reagents 214 and 314 are predetermined.
  • the two reagents 214 and 314 do not mix with each other because they are assembled to overlap each other, spaced apart.
  • a reagent for measuring blood glucose and a reagent for measuring hematocrit are used in combination, whereby a hematocrit correction effect can be seen only at a predetermined blood sugar concentration range, whereas according to an embodiment of the present invention, a reagent for measuring blood glucose ( 214) and the reagent 314 for measuring the hematocrit can be accurately corrected by the interference of the hematocrit without limiting the range of the blood glucose concentration.

Abstract

Disclosed are a sensor strip and a biomaterial measuring device using the same in which a structure of the sensor strip and an allocating method of components are changed to correct the interference of hematocrit irrespective of blood sugar levels, thereby allowing the measurement of a particular biomaterial in a biological sample such as blood, etc. The device comprises an electrode part for a subject to be measured by the sensor strip and a hematocrit electrode part, wherein the electrode part for a subject to be measured and the hematocrit electrode part are assembled in such an overlapping manner that a first reagent exposed to the electrode part for a subject to be measured and a second reagent exposed to the hematocrit electrode part face each other at a predetermined distance therebetween.

Description

센서 스트립 및 이를 이용한 생체 물질 측정 장치Sensor strip and biomaterial measuring device using same
본 출원은 2017년 06월 02일에 출원된 한국특허출원 10-2017-0068928호에 기초한 우선권을 주장하며, 해당 출원들의 명세서 및 도면에 개시된 모든 내용은 본 출원에 원용된다.This application claims the priority based on Korean Patent Application No. 10-2017-0068928 filed on June 02, 2017, all the contents disclosed in the specification and drawings of those applications are incorporated in this application.
본 발명은 혈액 등의 생체 시료에 있는 특정 생체 물질을 측정하기 위한 센서 스트립 및 이를 이용한 생체 물질 측정 장치에 관한 것이다. The present invention relates to a sensor strip for measuring a specific biological material in a biological sample such as blood and a biological material measuring apparatus using the same.
측정하고자 하는 대상물로부터 정보를 얻을 때 그 정보를 생물학적 요소를 이용하여 색, 형광, 전기적 신호 등과 같이 인식 가능한 유용한 신호로 변환시켜주는 시스템을 바이오 센서라 한다. 바이오 센서의 가장 대표적인 것으로는 혈액 내의 혈당을 측정하기 위한 혈당 측정 장치가 있다. A biosensor is a system that converts information from an object to be measured into useful signals that can be recognized, such as color, fluorescence, and electrical signals, using biological elements. The most representative of the biosensors is a blood glucose measurement apparatus for measuring blood glucose in blood.
혈당 측정 장치는 일반적으로 센서 스트립, 커넥터, 분석 장치 및 채혈기로 구성된다. 센서 스트립을 혈당 측정 장치에 있는 투입구에 끼워 넣고, 채혈기를 이용하여 손가락 끝을 채혈하여 손가락 끝에 채혈된 소량의 혈액을 혈당 측정 장치에 삽입된 센서 스트립에 대면 혈액이 센서 스트립의 투입구로 자동으로 빨려들어가 혈당 측정 값이 혈당 측정 장치의 화면에 표시된다. Blood glucose measurement devices generally comprise a sensor strip, a connector, an assay device and a blood collection device. Insert the sensor strip into the inlet of the glucose measuring device, draw a fingertip with a blood collector, and touch the small amount of blood collected at the fingertip with the sensor strip inserted into the glucose measuring device. Your blood glucose reading will be displayed on the screen of your blood sugar measurement device.
혈당 측정 장치와 같은 생체 물질 측정 장치로 혈액 내 생체 물질을 측정하는 경우 헤마토크릿(hematocrit, Hct), 습도, 온도 및 간섭 물질 등이 혈액 내 생체 물질의 측정 결과에 영향을 주어 생체 물질 측정 장치의 정확도에 영향을 준다. 혈당 측정 장치로 혈당을 측정하는 데 있어서 온도가 가장 큰 영향을 주는 원인이지만 대부분의 혈당 측정 장치에서 온도의 영향에 대한 보정이 행해지고 있다. 온도 다음으로 혈당 측정 결과에 영향을 주는 팩터(Factor)는 헤마토크릿이다. 헤마토크릿은 혈액에서 적혈구가 차지하고 있는 용적의 비중을 백분율료 표시한 것이다. 헤마토크릿의 정상 범위는 성인, 임산부, 신생아 등에 따라 각기 다르다. 각 개인간 차이는 있지만, 일반적 성인의 경우 정상 범위는 35-50%이나, 임산부의 경우에는 좀 더 낮은 편이고, 신생아는 좀 더 높은 편이다. 이러한 헤마토크릿의 광범위한 범위는 혈당 측정 장치와 같은 생체 물질 측정 장치에서 측정 결과에 대한 오류를 초래할 수 있다. 일반적으로 높은 헤마토크릿을 가진 혈액은 혈당 측정에 있어 실제 값보다 더 낮은 값을 나타내고, 반면에 낮은 헤마토크릿을 가진 혈액은 더 높은 값을 나타낸다.When measuring biomaterials in blood with a biomaterial measuring device such as a blood glucose measuring device, hematocrit (Hct), humidity, temperature, and interference substances affect the measurement results of the biomaterials in the blood, thereby increasing the accuracy of the biomaterial measuring device. Affects. Although temperature is the most significant cause in measuring blood glucose with a blood glucose measurement apparatus, correction of the influence of temperature is performed in most blood glucose measurement apparatuses. Next to temperature, the factor that affects blood glucose measurement results is hematocrit. Hematocrit is a percentage of the volume of red blood cells in the blood. The normal range of hematocrit varies among adults, pregnant women, and newborns. Although there are differences among individuals, the normal range is 35-50% for adults, but lower for pregnant women and higher for newborns. Such a wide range of hematocrit can lead to errors in measurement results in biomaterial measurement devices such as blood glucose measurement devices. In general, blood with high hematocrit shows lower values than actual values for blood glucose measurement, while blood with low hematocrit shows higher values.
이러한 헤마토크릿의 영향을 보정하는 방법에 대해서는 많은 연구가 이루어지고 있다. 대표적으로, 적혈구가 어떤 범위의 주파수에서는 전기적 부도체로 작용한다는 점을 이용하여 혈액에 교류 전원을 가해주어서 전도성을 측정하고 그 측정된 전도성으로부터 적혈구의 총량을 계산하여 헤마토크릿을 산출함으로써 헤마토크릿의 영향을 보정하는 방식이 있다. 그러나 이 방식은 혈액 내 생체 물질을 측정하는 데 있어서 헤마토크릿의 보정 시간이 오래 걸리고, 적혈구 이외의 다른 생체 물질 또한 전도성에 영향을 주게 되어 정확성이 낮은 단점이 있다.Much research has been made on how to correct the effects of hematocrit. Typically, red blood cells act as electrical insulators at a certain range of frequencies to apply alternating current to the blood to measure conductivity, calculate the total amount of red blood cells from the measured conductivity, and calculate the hematocrit to correct the effects of hematocrit. There is a way. However, this method takes a long time to calibrate the hematocrit for measuring biomaterials in the blood, and biomaterials other than red blood cells also affect conductivity, and thus have low accuracy.
한편, 국내등록특허 제10-0591246호는 혈구 간섭 보정제를 사용하여 헤마토크릿의 간섭을 효과적으로 보상할 수 있는 전기화학적 바이오센서용 테스트 스트립을 개시하고 있다. 해당 특허는, 혈구 간섭 보정제를 테스트 스트립에 도포되는 시약 등의 구성성분과 섞어 사용한다. 테스트 스트립으로 흡입된 혈액의 적혈구를 화학적으로 용해시켜 적혈구 내의 헤모글로빈을 외부로 유출시킨다. 유출된 헤모글로빈은 전자 전달체와 반응하여 전자를 전달하고, 이렇게 전달된 전자는 다시 전극으로 전달된다. 이러한 메카니즘을 통해 헤모글로빈-전자 전달체는 혈액 내의 적혈구의 양(적혈구 용적률)에 비례하는 전류가 전극에 흐르도록 한다. 그런데, 실제로 전극에 흐르는 전류, 즉 출력 전류는 효소-전자 전달체 반응을 통한 전류와, 헤모글로빈-전자 전달체 반응을 통한 전류가 합쳐진 것으로, 일정 혈당, 즉 글루코스 농도 범위에서만 효과가 나타나는 단점이 존재하게 된다. 헤모글로빈 농도에서 생성되는 전류의 세기는 글루코스 농도에 상관없이 일정하게 정해지기 때문에 글루코스 농도에 의해 생성된 전류의 세기에 따라 보정 정도가 달라진다. 따라서 저농도인 글루코스 70mg/dL 이하에서는 과보정 현상이 일어나며, 고농도인 글루코스 300mg/dL 이상에서는 보정이 미비하게 일어난다. 즉 보정 효과가 나타나는 글루코스 농도가 한정되는 것이다. On the other hand, Korean Patent No. 10-0591246 discloses a test strip for an electrochemical biosensor that can effectively compensate for the interference of hematocrit using a blood cell interference correction agent. The patent uses blood cell interference modifiers in combination with components such as reagents applied to test strips. The red blood cells of the blood drawn into the test strip are chemically dissolved to release hemoglobin in the red blood cells to the outside. The released hemoglobin reacts with an electron transporter to transfer electrons, which are then transferred back to the electrode. Through this mechanism, the hemoglobin-electron transporter causes a current to flow in the electrode proportional to the amount of red blood cells (red blood cell volume) in the blood. However, in reality, the current flowing through the electrode, that is, the output current, is the sum of the current through the enzyme-electron transporter reaction and the current through the hemoglobin-electron transporter reaction. . Since the strength of the current generated at the hemoglobin concentration is fixed regardless of the glucose concentration, the degree of correction depends on the strength of the current generated by the glucose concentration. Therefore, overcorrection occurs at low concentrations of glucose below 70 mg / dL, and inadequate correction occurs at high concentrations of 300 mg / dL or higher glucose. In other words, the glucose concentration at which the correction effect appears is limited.
본 발명은 상술한 문제점을 해결하기 위해 제안된 것으로, 센서 스트립의 구조 및 구성 성분의 배치 방법을 변화시켜 헤마토크릿의 간섭을 보정하여 혈액 등의 생체 시료에 있는 특정 생체 물질을 측정할 수 있도록 하는, 센서 스트립 및 이를 이용한 생체 물질 측정 장치를 제공하는 데 그 목적이 있다.The present invention has been proposed to solve the above problems, by changing the structure of the sensor strip and the arrangement method of the components to correct the interference of the hematocrit to measure a specific biological material in a biological sample such as blood, It is an object of the present invention to provide a sensor strip and a biomaterial measuring apparatus using the same.
일 측면에 따른, 혈액 내의 생체 물질을 측정하기 위한 센서 스트립은, 제 1 절연 기판과, 상기 제 1 절연 기판 상에 소정 간격으로 이격되어 형성된 제 1, 2 전극과, 상기 제 1, 2 전극의 적어도 일부에 대응하는 부분에 슬릿이 형성되고 상기 제 1, 2 전극 위에 설치되는 제 1 스페이서 필름과, 상기 슬릿에 노출된 상기 제 1, 2 전극의 적어도 일부에 도포되는 제 1 시약을 포함하는 측정 대상 전극부; 및 제 2 절연 기판과, 상기 제 2 절연 기판 상에 소정 간격으로 이격되어 형성된 제 3, 4 전극과, 상기 제 3, 4 전극의 적어도 일부에 대응하는 부분에 슬릿이 형성되고 상기 제 3, 4 전극 위에 설치되는 제 2 스페이서 필름과, 상기 제 2 스페이서 필름의 슬릿에 노출된 상기 제 3, 4 전극의 적어도 일부에 도포되는 제 2 시약을 포함하는 헤마토크릿 전극부;를 포함하고, 상기 측정 대상 전극부의 제 1 시약과 상기 헤마토크릿 전극부의 제 2 시약이 소정 간격으로 이격되어 마주보도록 상기 측정 대상 전극부와 상기 헤마토크릿 전극부는 포개져 조립된다.According to an aspect, a sensor strip for measuring a biomaterial in blood may include a first insulating substrate, first and second electrodes spaced apart at predetermined intervals from the first insulating substrate, and the first and second electrodes. A measurement including a first spacer film having a slit formed in at least a portion corresponding to at least a part thereof and installed on the first and second electrodes, and a first reagent applied to at least a portion of the first and second electrodes exposed to the slit A target electrode portion; And slits are formed on a second insulating substrate, third and fourth electrodes spaced apart from each other at predetermined intervals on the second insulating substrate, and portions corresponding to at least a portion of the third and fourth electrodes. And a hematocrit electrode unit including a second spacer film disposed on an electrode and a second reagent applied to at least a portion of the third and fourth electrodes exposed to the slit of the second spacer film. The measurement target electrode portion and the hematocrit electrode portion are stacked and assembled so that the first reagent of the negative portion and the second reagent of the hematocrit electrode portion face each other at a predetermined interval.
상기 측정 대상 전극부의 상기 제 1 시약의 도포 두께는 상기 제 1 스페이서 필름의 두께보다 작고, 상기 헤마토크릿 전극부의 상기 제 2 시약의 도포 두께는 상기 제 2 스페이서 필름의 두께보다 작음으로써, 상기 제 1, 2 시약 간의 소정 간격을 형성할 수 있다.The coating thickness of the first reagent of the measurement target electrode portion is smaller than the thickness of the first spacer film, and the coating thickness of the second reagent of the hematocrit electrode portion is smaller than the thickness of the second spacer film. The predetermined interval between two reagents can be formed.
상기 제 1 시약과 상기 제 2 시약은, 동일한 혈액에 대해 동시에 반응할 수 있다. The first reagent and the second reagent may react simultaneously with the same blood.
상기 제 1 시약은, 혈액 내 혈당에 반응하는 시약이고, 상기 제 2 시약은 혈액 내 적혈구에 반응하는 시약일 수 있다.The first reagent may be a reagent that reacts with blood glucose in the blood, and the second reagent may be a reagent that reacts with red blood cells in the blood.
상기 측정 대상 전극부와 상기 헤마토크릿 전극부는 상기 제 1, 2 시약의 종류는 상이하고 전극들의 배치 위치 및 전체 형상은 서로 동일할 수 있다.The measurement target electrode part and the hematocrit electrode part may have different types of the first and second reagents, and the arrangement position and the overall shape of the electrodes may be the same.
다른 측면에 따른, 혈액 내의 생체 물질을 측정하기 위한 생체 물질 측정 장치는, 상기 혈액에 반응하여 반응 신호를 출력하는 센서 스트립; 상기 센서 스트립에서 출력되는 상기 반응 신호를 분석하여 상기 혈액 내 특정 생체 물질의 농도를 측정하는 분석 장치; 및 상기 센서 스트립과 상기 분석 장치를 연결하는 커넥터를 포함하고, 상기 센서 스트립은, 제 1 절연 기판과, 상기 제 1 절연 기판 상에 소정 간격으로 이격되어 형성된 제 1, 2 전극과, 상기 제 1, 2 전극의 적어도 일부에 대응하는 부분에 슬릿이 형성되고 상기 제 1, 2 전극 위에 설치되는 제 1 스페이서 필름과, 상기 슬릿에 노출된 상기 제 1, 2 전극의 적어도 일부에 도포되는 제 1 시약을 포함하는 측정 대상 전극부; 및 제 2 절연 기판과, 상기 제 2 절연 기판 상에 소정 간격으로 이격되어 형성된 제 3, 4 전극과, 상기 제 3, 4 전극의 적어도 일부에 대응하는 부분에 슬릿이 형성되고 상기 제 3, 4 전극 위에 설치되는 제 2 스페이서 필름과, 상기 제 2 스페이서 필름의 슬릿에 노출된 상기 제 3, 4 전극의 적어도 일부에 도포되는 제 2 시약을 포함하는 헤마토크릿 전극부;를 포함하고, 상기 측정 대상 전극부의 제 1 시약과 상기 헤마토크릿 전극부의 제 2 시약이 소정 간격으로 이격되어 마주보도록 상기 측정 대상 전극부와 상기 헤마토크릿 전극부는 포개져 조립된다.According to another aspect, a biomaterial measuring apparatus for measuring a biomaterial in blood includes: a sensor strip configured to output a reaction signal in response to the blood; An analysis device for analyzing the reaction signal output from the sensor strip to measure a concentration of a specific biomaterial in the blood; And a connector connecting the sensor strip and the analysis device, wherein the sensor strip comprises: a first insulating substrate, first and second electrodes spaced apart at predetermined intervals from the first insulating substrate, and the first insulating substrate; And a first spacer film formed on a portion corresponding to at least a portion of the second electrode and disposed on the first and second electrodes, and a first reagent applied to at least a portion of the first and second electrodes exposed to the slit. A measurement target electrode part including a; And slits are formed on a second insulating substrate, third and fourth electrodes spaced apart from each other at predetermined intervals on the second insulating substrate, and portions corresponding to at least a portion of the third and fourth electrodes. And a hematocrit electrode unit including a second spacer film disposed on an electrode and a second reagent applied to at least a portion of the third and fourth electrodes exposed to the slit of the second spacer film. The measurement target electrode portion and the hematocrit electrode portion are stacked and assembled so that the first reagent of the negative portion and the second reagent of the hematocrit electrode portion face each other at a predetermined interval.
상기 측정 대상 전극부와 상기 헤마토크릿 전극부는 상기 제 1, 2 시약의 종류는 상이하고 전극들의 배치 위치 및 전체 형상은 서로 동일하고, 상기 제 1, 3 전극은, 작동 전극이고, 상기 제 2, 4 전극은 기준 전극일 수 있다.The measurement target electrode portion and the hematocrit electrode portion are different in the kind of the first and second reagents, and the arrangement position and the overall shape of the electrodes are the same, and the first and third electrodes are working electrodes, and the second and fourth The electrode may be a reference electrode.
상기 커넥터는, 상기 제 1 내지 4 전극 각각에 연결되는 단자들을 포함하되, 상기 제 1 전극으로 전압을 인가하는 단자, 상기 제 2 전극으로부터 전류를 검출하는 단자, 상기 제 4 전극으로부터 전류를 검출하는 단자, 상기 제 3 전극으로 전압을 인가하는 단자의 순서로 배치될 수 있다.The connector includes terminals connected to each of the first to fourth electrodes, the terminal for applying a voltage to the first electrode, a terminal for detecting a current from the second electrode, and a current for detecting the current from the fourth electrode. Terminals may be arranged in order of applying a voltage to the third electrode.
상기 측정 대상 전극부의 상기 제 1 시약의 도포 두께는 상기 제 1 스페이서 필름의 두께보다 작고, 상기 헤마토크릿 전극부의 상기 제 2 시약의 도포 두께는 상기 제 2 스페이서 필름의 두께보다 작음으로써, 상기 제 1, 2 시약 간의 소정 간격을 형성할 수 있다.The coating thickness of the first reagent of the measurement target electrode portion is smaller than the thickness of the first spacer film, and the coating thickness of the second reagent of the hematocrit electrode portion is smaller than the thickness of the second spacer film. The predetermined interval between two reagents can be formed.
상기 제 1 시약과 상기 제 2 시약은, 동일한 혈액에 대해 동시에 반응할 수 있다.The first reagent and the second reagent may react simultaneously with the same blood.
본 발명에 따르면, 센서 스트립의 측정 대상 전극부와 헤마토크릿 전극부를 대면형의 구조로 놓이게 하여 측정 대상 전극부와 헤마토크릿 전극부의 시약들이 서로 섞이지 않도록 하면서 하나의 동일한 혈액에 대해 혈당과 같은 특정 생체 물질과 헤마토크릿을 동시에 측정할 수 있도록 하여 측정 시간을 단축하면서도 각각의 측정 결과 간의 영향을 없애 각 측정 결과의 정확도를 높인다. 이에 따라 혈당과 같은 특정 생체 물질의 농도를 측정하는 데 있어서 헤마토크릿의 영향을 정확히 반영하여 보정함으로써 특정 생체 물질의 농도의 측정 결과의 정확도를 높인다.According to the present invention, the measuring electrode portion and the hematocrit electrode portion of the sensor strip are placed in a face-to-face structure so that the reagents of the measuring electrode portion and the hematocrit electrode portion are not mixed with each other, and a specific biological material such as blood sugar is added to the same blood. The hematocrit can be measured at the same time, reducing the measurement time while improving the accuracy of each measurement result by eliminating the influence between each measurement result. Accordingly, by accurately reflecting and correcting the influence of hematocrit in measuring the concentration of a specific biomaterial such as blood sugar, the accuracy of the measurement result of the concentration of the specific biomaterial is improved.
도 1은 본 발명의 일 실시예에 따른 생체 물질 측정 장치를 나타낸 블록도이다.1 is a block diagram illustrating a biomaterial measuring apparatus according to an exemplary embodiment of the present invention.
도 2는 본 발명의 일 실시예에 따른 센서 스트립의 측정 대상 전극부의 구성을 나타낸 도면이다.2 is a view showing the configuration of the electrode to be measured in the sensor strip according to an embodiment of the present invention.
도 3은 본 발명의 일 실시예에 따른 센서 스트립의 헤마토크릿 전극부의 구성을 나타낸 도면이다.3 is a view showing the configuration of the hematocrit electrode portion of the sensor strip according to an embodiment of the present invention.
도 4는 도 2의 측정 대상 전극부와 도 3의 헤마토크릿 전극부를 결합한 센서 스트립을 나타낸 도면이다.FIG. 4 is a diagram illustrating a sensor strip in which the electrode to be measured of FIG. 2 and the hematocrit electrode of FIG. 3 are combined.
도 5는 생체 물질 측정 장치의 커넥터와 도 4의 센서 스트립의 결합 전 연결 구조를 설명하는 도면이다.FIG. 5 is a view illustrating a connection structure before coupling of a connector of the biomaterial measuring apparatus and the sensor strip of FIG. 4.
도 6은 생체 물질 측정 장치의 커넥터와 도 4의 센서 스트립의 결합 후 연결 구조를 설명하는 도면이다.FIG. 6 is a diagram illustrating a connection structure after coupling of a connector of the biomaterial measuring apparatus to the sensor strip of FIG. 4.
상술한 목적, 특징 및 장점은 첨부된 도면과 관련한 다음의 상세한 설명을 통하여 보다 분명해 질 것이며, 그에 따라 본 발명이 속하는 기술분야에서 통상의 지식을 가진 자가 본 발명의 기술적 사상을 용이하게 실시할 수 있을 것이다. 또한, 본 발명을 설명함에 있어서 본 발명과 관련된 공지 기술에 대한 구체적인 설명이 본 발명의 요지를 불필요하게 흐릴 수 있다고 판단되는 경우에 그 상세한 설명을 생략하기로 한다. 이하, 첨부된 도면을 참조하여 본 발명에 따른 바람직한 일 실시예를 상세히 설명하기로 한다.The above objects, features and advantages will become more apparent from the following detailed description taken in conjunction with the accompanying drawings, whereby those skilled in the art may easily implement the technical idea of the present invention. There will be. In addition, in describing the present invention, when it is determined that the detailed description of the known technology related to the present invention may unnecessarily obscure the gist of the present invention, the detailed description thereof will be omitted. Hereinafter, exemplary embodiments of the present invention will be described in detail with reference to the accompanying drawings.
도 1은 본 발명의 일 실시예에 따른 생체 물질 측정 장치를 나타낸 블록도이다. 도 1을 참조하면, 본 실시예에 따른 생체 물질 측정 장치는, 센서 스트립(110), 커넥터(120) 및 분석 장치(130)를 포함한다. 1 is a block diagram illustrating a biomaterial measuring apparatus according to an exemplary embodiment of the present invention. Referring to FIG. 1, the biomaterial measuring apparatus according to the present exemplary embodiment includes a sensor strip 110, a connector 120, and an analysis device 130.
센서 스트립(110)은, 인간이나 동물로부터 채취한 혈액이나 체액 등의 검체를 분석하기 위해 사용되는 수단으로서, 공급된 검체의 혈당 농도, 혈중 알코올 농도, 젖산 농도 등 다양한 종류의 측정 대상 생체 물질에 대응하는 신호를 출력할 수 있다. 본 실시예에서 상기 센서 스트립(110)은 혈당을 측정하기 위한 스트립으로서, 공급된 검체의 혈당을 측정하여 이에 대응하는 신호를 출력할 수 있다. 여기서, 센서 스트립(110)은 각각의 검체 측정시마다 교체하는 소모품일 수 있다. 센서 스트립(110)은, 혈당을 측정하기 위한 측정 대상 전극부와, 헤마토크릿을 측정하기 위한 헤마토크릿 전극부를 포함하고, 상기 측정 대상 전극부 위에 형성된 시약과 상기 헤마토크릿 전극부 위에 형성된 시약이 서로 마주보도록 대면한다. 이에 관해서는 이하에서 자세히 설명한다.The sensor strip 110 is a means used to analyze a sample such as blood or body fluid collected from a human or animal, and is used for various kinds of biological substances to be measured such as blood glucose level, blood alcohol concentration, and lactic acid concentration of the supplied sample. A corresponding signal can be output. In the present exemplary embodiment, the sensor strip 110 is a strip for measuring blood sugar, and measures a blood sugar of a supplied sample and outputs a signal corresponding thereto. Here, the sensor strip 110 may be a consumable to be replaced at each sample measurement. The sensor strip 110 includes an electrode to be measured for measuring blood sugar and a hematocrit electrode for measuring hematocrit, and the reagent formed on the electrode to be measured and the reagent formed on the hematocrit electrode face to face each other. do. This will be described in detail below.
커넥터(120)는 상기 센서 스트립(110)을 상기 분석 장치(130)와 연결하기 위한 것으로서, 상기 센서 스트립(110)과 상기 분석 장치(130) 간의 인터페이스 역할을 한다. 커넥터(120)는 상기 센서 스트립(110)의 측정 대상 전극부로 전압을 인가하는 단자와, 상기 측정 대상 전극부로부터 수신되는 전류를 검출하는 단자, 그리고 헤마토크릿 전극부로 전압을 인가하는 단자와, 상기 헤마토크릿 전극부로부터 수신되는 전류를 검출하는 단자를 포함할 수 있다. The connector 120 is for connecting the sensor strip 110 with the analysis device 130, and serves as an interface between the sensor strip 110 and the analysis device 130. The connector 120 includes a terminal for applying a voltage to the electrode to be measured of the sensor strip 110, a terminal for detecting a current received from the electrode to be measured, and a terminal for applying a voltage to the hematocrit electrode, and the hematocrit. It may include a terminal for detecting a current received from the electrode unit.
분석 장치(130)는, 생체 물질 측정 장치의 전반적인 동작을 제어하며, 상기 커넥터(120)를 통해 상기 센서 스트립(110)으로 전압을 인가하고, 상기 센서 스트립(110)으로부터 수신되는 전류를 분석하여 측정 대상 생체 물질의 농도 등을 측정한다. 분석 장치(130)는 연산 장치, 배터리, 메모리 등을 포함할 수 있다. 본 실시예에서, 분석 장치(130)는 상기 센서 스트립(110)의 측정 대상 전극부로부터 수신되는 전류를 토대로 검체 내 혈당 농도를 측정하고, 또한, 상기 센서 스트립(110)의 헤마토크릿 전극부로부터 수신되는 전류를 토대로 검체 내 헤마토크릿을 측정한다. 분석 장치(130)는 상기 측정된 혈당 농도를 상기 측정된 헤마토크릿을 이용하여 보정하고, 그 보정된 혈당 농도의 값을 출력한다. 분석 장치(130)는, 메모리를 포함하고, 메모리에는 헤마토크릿 측정 값별 혈당 농도 보정 값이 매칭되어 저장된다. 분석 장치(130)는, 헤마토크릿 전극부를 이용하여 측정한 헤마토크릿의 측정 값에 대응하는 혈당 농도 보정 값을 메모리에서 독출하고, 측정 대상 전극부를 이용하여 측정한 혈당 농도 값에 상기 독출한 혈당 농도 보정 값을 반영하여 최종적인 혈당 농도의 값을 산출할 수 있다. 분석 장치(130)는 LED 등을 이용하여 혈당 농도의 값을 출력할 수 있고, 또는 디스플레이 수단을 통해 혈당 농도의 값을 디지털 수치로 출력할 수도 있다. The analysis device 130 controls the overall operation of the biomaterial measuring device, applies a voltage to the sensor strip 110 through the connector 120, and analyzes the current received from the sensor strip 110. The concentration of the biological material to be measured is measured. The analysis device 130 may include a computing device, a battery, a memory, and the like. In the present embodiment, the analysis device 130 measures the blood glucose concentration in the sample based on the current received from the electrode to be measured of the sensor strip 110, and also receives from the hematocrit electrode of the sensor strip 110. The hematocrit in the sample is measured based on the current. The analyzing apparatus 130 corrects the measured blood glucose concentration by using the measured hematocrit, and outputs the corrected blood glucose concentration value. The analyzing apparatus 130 includes a memory, and the blood glucose concentration correction value for each hematocrit measurement value is matched and stored in the memory. The analyzing apparatus 130 reads out the blood sugar concentration correction value corresponding to the measured value of the hematocrit measured using the hematocrit electrode unit from the memory, and reads the blood sugar concentration correction value to the blood sugar concentration value measured using the measurement target electrode unit. The final blood glucose level can be calculated by reflecting this. The analysis device 130 may output the value of the blood sugar level using an LED or the like, or may output the value of the blood sugar level as a digital value through a display means.
도 2는 본 발명의 일 실시예에 따른 센서 스트립(110)의 측정 대상 전극부(210)의 구성을 나타낸 도면이다. 도 2를 참조하면, 센서 스트립(110)의 측정 대상 전극부(210)는 혈당 등과 같은 측정 대상 생체 물질을 측정하기 위한 수단으로서, 하부 절연 기판(211), 스페이서 필름(213), 그리고 하부 절연 기판(211) 위에 형성되는 작동 전극(212a) 및 기준 전극(212b)을 포함한다. 2 is a view showing the configuration of the electrode to be measured 210 of the sensor strip 110 according to an embodiment of the present invention. Referring to FIG. 2, the electrode 210 to be measured of the sensor strip 110 is a means for measuring a biological material to be measured, such as blood sugar, and includes a lower insulating substrate 211, a spacer film 213, and a lower insulating layer. A working electrode 212a and a reference electrode 212b formed on the substrate 211 are included.
하부 절연 기판(211)은, 유리 혹은 무기재료 기판, 플라스틱 기판 또는 필름 등일 수 있으며, 실시예에 따라서는 PET(Polyethylene Terephthalate), 폴리카보네이트 필름(Polycarbonate film) 등이 사용될 수 있다. 하부 절연 기판(211) 위에 형성되는 한 쌍의 전극, 즉 작동 전극(212a) 및 기준 전극(212b)은 소정 간격을 두고 이격되어 하부 절연 기판(211) 위에 배치된다. 작동 전극(212a) 및 기준 전극(212b)은 금이나 은을 원료로 형성될 수 있고, 또는 카본 잉크로 인쇄하여 형성함으로써 제품의 제조단가를 절감할 수 있다. 작동 전극(212a) 및 기준 전극(212b)은 하부 절연 기판(211) 상에 도전 물질을 도포한 후, 전극의 형상을 레이저 패터닝하거나, 마스킹하는 등의 방식으로 형성될 수도 있다. 하부 절연 기판(211)에는, 상기 작동 전극(212a) 및 상기 기준 전극(212b) 이외, 검체, 예를 들어 혈액의 유입을 감지하기 위한 혈액 인식 전극 등이 더 형성될 수 있다. The lower insulating substrate 211 may be a glass or inorganic material substrate, a plastic substrate, or a film. In some embodiments, a polyethylene terephthalate (PET), a polycarbonate film, or the like may be used. The pair of electrodes formed on the lower insulating substrate 211, that is, the working electrode 212a and the reference electrode 212b are spaced apart from each other at a predetermined interval and disposed on the lower insulating substrate 211. The working electrode 212a and the reference electrode 212b may be formed of gold or silver as a raw material, or may be manufactured by printing with carbon ink to reduce the manufacturing cost of the product. The working electrode 212a and the reference electrode 212b may be formed by applying a conductive material on the lower insulating substrate 211 and then laser patterning or masking the shape of the electrode. In addition to the working electrode 212a and the reference electrode 212b, a lower recognition substrate 211 may further include a blood recognition electrode for detecting the inflow of a sample, for example, blood.
스페이서 필름(213)은, 작동 전극(212a) 및 기준 전극(212b)이 형성된 하부 절연 기판(211)의 상면을 덮는다. 스페이서 필름(213)은, 작동 전극(212a) 및 기준 전극(212b)이 형성된 하부 절연 기판(211)의 상면에 소정 두께로 절연 잉크가 도포되는 방식으로 형성될 수 있으나 여기에 제한되는 것은 아니다. 스페이서 필름(213)은 하부 절연 기판(211)과 동일한 재료로 만들어지는 또 다른 절연 기판일 수 있다. 스페이서 필름(213)은, 작동 전극(212a) 및 기준 전극(212b)을 대향하는 부분에 슬릿(213a)이 형성되어 있고, 그 슬릿(213a)을 통해 작동 전극(212a) 및 기준 전극(212b)의 일부분이 노출된다. 스페이서 필름(213)의 상기 슬릿(213a)에 측정 시약(214)이 위치한다. 측정 시약(214)은 슬릿(213a)을 통해 노출된 작동 전극(212a) 및 기준 전극(212b)을 가로질러 위치하게 된다. 바람직하게, 측정 시약(214)의 도포 두께는 스페이서 필름(213)의 두께보다 작다. 시약(214)은 스페이서 필름(213)을 전극(212a, 212b) 위에 덮은 후에 슬릿(213a)을 통해 도포될 수 있고, 또는 스페이서 필름(213)을 덮기 전에, 슬릿(213a)의 영역에 대응하는 전극(212a, 212b)의 영역에 미리 도포될 수도 있다. 한편, 스페이서 필름(213)은 전극(212a, 212b)의 주요 부분을 덮고 커넥터(120)의 단자들에 연결되는 전극(212a, 212b)의 일 부분은 덮지 않고 노출시킨다. The spacer film 213 covers the upper surface of the lower insulating substrate 211 on which the working electrode 212a and the reference electrode 212b are formed. The spacer film 213 may be formed in such a manner that an insulating ink is applied to the upper surface of the lower insulating substrate 211 on which the working electrode 212a and the reference electrode 212b are formed to have a predetermined thickness, but is not limited thereto. The spacer film 213 may be another insulating substrate made of the same material as the lower insulating substrate 211. In the spacer film 213, a slit 213a is formed at a portion facing the working electrode 212a and the reference electrode 212b, and the working electrode 212a and the reference electrode 212b are formed through the slit 213a. A portion of is exposed. The measurement reagent 214 is positioned in the slit 213a of the spacer film 213. The measurement reagent 214 is positioned across the working electrode 212a and the reference electrode 212b exposed through the slit 213a. Preferably, the application thickness of the measurement reagent 214 is smaller than the thickness of the spacer film 213. The reagent 214 may be applied through the slit 213a after covering the spacer film 213 over the electrodes 212a and 212b, or before covering the spacer film 213, corresponding to the area of the slit 213a. It may be applied in advance to the regions of the electrodes 212a and 212b. Meanwhile, the spacer film 213 covers the main portions of the electrodes 212a and 212b and exposes a portion of the electrodes 212a and 212b connected to the terminals of the connector 120 without being covered.
혈당 측정을 위한 측정 시약(214)은 혈당 효소, 생화학 반응에 의해 생성된 전하를 전극(212a, 212b) 표면까지 효과적으로 전달할 수 있는 전자 전달체, 전극(212a, 212b) 표면과 시약층 간의 지지체로서 사용되는 친수성 고분자 화합물, 분산제로서 사용되는 계면활정제를 포함하여 구성될 수 있다. 사용되는 효소는 검출하고자 하는 물질 또는 필요에 따라 다양하며, 예를 들어 글루코스 산화효소(glucose oxidase), 글루코스 탈수소화효소(glucose dehydrogenase)를 사용할 수 있다. 친수성 고분자 화합물은 전극(212a, 212b) 상에 시약(214)을 용이하게 고정시키기 위해 필요한 것으로, 예를 들어 셀룰로오스, 하이드록시에틸 셀룰로오스 등이 있다. 계면활성제는 시약(214)이 전극(212a, 212b) 표면에 잘 분산되도록 하는 것으로, 예를 들어 트리톤 X-100 등이 있다. 시약의 구체적인 제조방법, 사용될 수 있는 시약, 전자 전달체의 예는 미국특허 제5,762,770호 공보를 참조할 수 있다. 미국특허 제5,762,770호의 내용은 여기에서의 인용에 의해 본 명세서에 포함되는 것으로 한다.Measuring reagent 214 for blood glucose measurement is used as a carrier between the surface of the electrode 212a, 212b and the reagent layer, an electron carrier that can effectively transfer the charge generated by the blood glucose enzyme, biochemical reaction to the surface of the electrode (212a, 212b) It may be configured to include a hydrophilic polymer compound, which is used as a surfactant, a surfactant. The enzyme to be used varies depending on the substance to be detected or needs, and for example, glucose oxidase, glucose dehydrogenase can be used. The hydrophilic polymer compound is necessary to easily fix the reagent 214 on the electrodes 212a and 212b. Examples thereof include cellulose and hydroxyethyl cellulose. The surfactant is such that the reagent 214 is well dispersed on the surfaces of the electrodes 212a and 212b, for example Triton X-100. See US Pat. No. 5,762,770 for specific methods of preparing the reagents, examples of reagents that may be used, and electron transporters. The contents of U.S. Patent No. 5,762,770 are incorporated herein by reference.
도 3은 본 발명의 일 실시예에 따른 센서 스트립(110)의 헤마토크릿 전극부(310)의 구성을 나타낸 도면이다. 도 3을 참조하면, 센서 스트립(110)의 헤마토크릿 전극부(310)는 혈액 내 적혈구의 용적 비율, 즉 헤마토크릿을 측정하기 위한 수단으로서, 하부 절연 기판(311), 스페이서 필름(313), 그리고 하부 절연 기판(311) 위에 형성되는 작동 전극(312a) 및 기준 전극(312b)을 포함한다. 도 3에 도시된 헤마토크릿 전극부(310)의 전체적인 형상 및 구성요소의 배치 위치는 도 2에 도시된 측정 대상 전극부(210)의 전체적인 형상과 동일하다. 3 is a view showing the configuration of the hematocrit electrode portion 310 of the sensor strip 110 according to an embodiment of the present invention. Referring to FIG. 3, the hematocrit electrode part 310 of the sensor strip 110 is a means for measuring the volume ratio of red blood cells, that is, hematocrit, in the blood, and includes a lower insulating substrate 311, a spacer film 313, and a lower part. The operation electrode 312a and the reference electrode 312b formed on the insulating substrate 311 are included. The overall shape of the hematocrit electrode part 310 shown in FIG. 3 and the arrangement position of the components are the same as the overall shape of the electrode object 210 to be measured shown in FIG. 2.
하부 절연 기판(311)은, 유리 혹은 무기재료 기판, 플라스틱 기판 또는 필름 등일 수 있으며, 실시예에 따라서는 PET(Polyethylene Terephthalate), 폴리카보네이트 필름(Polycarbonate film) 등이 사용될 수 있다. 하부 절연 기판(311) 위에 형성되는 한 쌍의 전극, 즉 작동 전극(312a) 및 기준 전극(312b)은 소정 간격을 두고 이격되어 하부 절연 기판(311) 위에 배치된다. 작동 전극(312a) 및 기준 전극(312b)은 금이나 은을 원료로 형성될 수 있고, 또는 카본 잉크로 인쇄하여 형성함으로써 제품의 제조단가를 절감할 수 있다. 작동 전극(312a) 및 기준 전극(312b)은 하부 절연 기판(311) 상에 도전 물질을 도포한 후, 전극의 형상을 레이저 패터닝하거나, 마스킹하는 등의 방식으로 형성될 수도 있다. 하부 절연 기판(311)에는, 상기 작동 전극(312a) 및 상기 기준 전극(312b) 이외, 검체, 예를 들어 혈액의 유입을 감지하기 위한 혈액 인식 전극 등이 더 형성될 수 있다. The lower insulating substrate 311 may be a glass or an inorganic material substrate, a plastic substrate, or a film. In some embodiments, a polyethylene terephthalate (PET), a polycarbonate film, or the like may be used. The pair of electrodes formed on the lower insulating substrate 311, that is, the working electrode 312a and the reference electrode 312b are spaced apart from each other at a predetermined interval and disposed on the lower insulating substrate 311. The working electrode 312a and the reference electrode 312b may be formed of gold or silver as a raw material, or may be formed by printing with carbon ink to reduce the manufacturing cost of the product. The working electrode 312a and the reference electrode 312b may be formed by applying a conductive material on the lower insulating substrate 311 and then laser patterning or masking the shape of the electrode. In addition to the working electrode 312a and the reference electrode 312b, a lower recognition substrate 311 may further include a blood recognition electrode for detecting the inflow of a sample, for example, blood.
스페이서 필름(313)은, 작동 전극(312a) 및 기준 전극(312b)이 형성된 하부 절연 기판(311)의 상면을 덮는다. 스페이서 필름(313)은, 작동 전극(312a) 및 기준 전극(312b)이 형성된 하부 절연 기판(311)의 상면에 소정 두께로 절연 잉크가 도포되는 방식으로 형성될 수 있으나 여기에 제한되는 것은 아니다. 스페이서 필름(313)은 하부 절연 기판(311)과 동일한 재료로 만들어지는 또 다른 절연 기판일 수 있다. 스페이서 필름(313)은, 작동 전극(312a) 및 기준 전극(312b)을 대향하는 부분에 슬릿(313a)이 형성되어 있고, 그 슬릿(313a)을 통해 작동 전극(312a) 및 기준 전극(312b)의 일부분이 노출된다. 스페이서 필름(313)의 상기 슬릿(313a)에 헤마토크릿 측정을 위한측정 시약(314)이 위치한다. 측정 시약(314)은 슬릿(313a)을 통해 노출된 작동 전극(312a) 및 기준 전극(312b)을 가로질러 위치하게 된다. 바람직하게, 측정 시약(314)의 도포 두께는 스페이서 필름(313)의 두께보다 작다. 시약(314)은 스페이서 필름(313)을 전극(312a, 312b) 위에 덮은 후에 슬릿(313a)을 통해 도포될 수 있고, 또는 스페이서 필름(313)을 덮기 전에, 슬릿(313a)의 영역에 대응하는 전극(312a, 312b)의 영역에 미리 도포될 수도 있다. 한편, 스페이서 필름(313)은 전극(312a, 312b)의 주요 부분을 덮고 커넥터(120)의 단자들에 연결되는 전극(312a, 312b)의 일 부분은 덮지 않고 노출시킨다. The spacer film 313 covers the upper surface of the lower insulating substrate 311 on which the working electrode 312a and the reference electrode 312b are formed. The spacer film 313 may be formed in such a manner that an insulating ink is applied to the upper surface of the lower insulating substrate 311 on which the working electrode 312a and the reference electrode 312b are formed to have a predetermined thickness, but is not limited thereto. The spacer film 313 may be another insulating substrate made of the same material as the lower insulating substrate 311. In the spacer film 313, a slit 313a is formed at a portion facing the working electrode 312a and the reference electrode 312b, and the working electrode 312a and the reference electrode 312b are formed through the slit 313a. A portion of is exposed. In the slit 313a of the spacer film 313, a measurement reagent 314 for measuring hematocrit is located. The measurement reagent 314 is positioned across the working electrode 312a and the reference electrode 312b exposed through the slit 313a. Preferably, the application thickness of the measurement reagent 314 is smaller than the thickness of the spacer film 313. The reagent 314 may be applied through the slit 313a after covering the spacer film 313 over the electrodes 312a and 312b, or corresponding to the area of the slit 313a before covering the spacer film 313. It may be applied in advance to the regions of the electrodes 312a and 312b. Meanwhile, the spacer film 313 covers the main portions of the electrodes 312a and 312b and exposes a portion of the electrodes 312a and 312b connected to the terminals of the connector 120 without being covered.
헤마토크릿 측정을 위한 측정 시약(314)은 혈당 측정 시약에서 효소가 제외되고, 전자 전달체로서 페리시아나이드가 사용된다. 그리고 혈구 간섭 보정제가 포함된다. 혈구 간섭 보정제는 적혈구를 용혈시키기 위해 필요한 것으로, 예를 들어 사포닌, 소디움 데옥시 콜레이트, 소디움 콜레이트 등이 있다.The measurement reagent 314 for hematocrit measurement excludes the enzyme from the blood glucose measurement reagent, and ferricyanide is used as the electron transporter. And blood cell interference compensators. Blood cell interference modifiers are required to hemolyze red blood cells, such as saponins, sodium deoxy cholate, sodium cholate, and the like.
도 4는 도 2의 측정 대상 전극부와 도 3의 헤마토크릿 전극부를 결합한 센서 스트립을 나타낸 도면이다. 도 4를 참조하면, 센서 스트립(110)은, 측정 대상 전극부(210)의 측정 시약(214)과 헤마토크릿 전극부(310)의 측정 시약(314)이 서로 마주보도록, 상기 측정 대상 전극부(210)와 상기 헤마토크릿 전극부(310)가 서로 대면한다. 측정 대상 전극부(210)의 측정 시약(214)과 헤마토크릿 전극부(310)의 측정 시약(314)이 서로 마주보도록 두 전극부(210, 310)는 서로 포개지고, 측정 시약(214, 314) 각각의 도포 두께는 스페이서 필름(213, 313)의 두께보다 작기 때문에, 혈액은 측정 대상 전극부(210)의 측정 시약(214)과 헤마토크릿 전극부(310)의 측정 시약(314) 사이에 투입되어, 측정 시약(214, 314)에 각각 반응하게 된다. 상기 측정 대상 전극부(210)의 스페이서 필름(213)과 상기 헤마토크릿 전극부(310)의 스페이서 필름(213)은 접착제, 양면 테이프 등으로 접착될 수 있다. FIG. 4 is a diagram illustrating a sensor strip in which the electrode to be measured of FIG. 2 and the hematocrit electrode of FIG. 3 are combined. Referring to FIG. 4, the sensor strip 110 may be configured such that the measurement reagent 214 of the measurement target electrode part 210 and the measurement reagent 314 of the hematocrit electrode part 310 face each other. 210 and the hematocrit electrode part 310 face each other. The two electrode portions 210 and 310 overlap each other so that the measurement reagent 214 of the measurement target electrode portion 210 and the measurement reagent 314 of the hematocrit electrode portion 310 face each other, and the measurement reagents 214 and 314. Since the respective coating thicknesses are smaller than the thicknesses of the spacer films 213 and 313, blood is introduced between the measurement reagent 214 of the electrode portion 210 to be measured and the measurement reagent 314 of the hematocrit electrode portion 310. And the reaction reagents 214 and 314, respectively. The spacer film 213 of the electrode to be measured 210 and the spacer film 213 of the hematocrit electrode 310 may be adhered with an adhesive, a double-sided tape, or the like.
도 5는 생체 물질 측정 장치의 커넥터와 도 4의 센서 스트립의 결합 전 연결 구조를 설명하는 도면이고, 도 6은 생체 물질 측정 장치의 커넥터와 도 4의 센서 스트립의 결합 후 연결 구조를 설명하는 도면이다. 도 5 및 도 6을 참조하면, 생체 물질 측정 장치의 커넥터(120)는, 상기 센서 스트립(110)의 측정 대상 전극부(210)의 작동 전극(212a)으로 전압을 인가하는 단자(510a)와, 측정 대상 전극부(210)의 기준 전극(212b)의 전류를 검출하는 단자(510b), 그리고 헤마토크릿 전극부(310)의 작동 전극(312a)으로 전압을 인가하는 단자(511a)와, 헤마토크릿 전극부(310)의 전류를 검출하는 단자(511b)를 포함한다.5 is a view illustrating a connection structure before coupling the connector of the biomaterial measuring device and the sensor strip of FIG. 4, and FIG. 6 is a view illustrating a connection structure after coupling the connector of the biomaterial measuring device and the sensor strip of FIG. 4. to be. 5 and 6, the connector 120 of the biomaterial measuring apparatus includes a terminal 510a for applying a voltage to the working electrode 212a of the electrode to be measured 210 of the sensor strip 110. , A terminal 510b for detecting a current of the reference electrode 212b of the electrode to be measured 210, a terminal 511a for applying a voltage to the working electrode 312a of the hematocrit electrode part 310, and a hematocrit electrode It includes a terminal 511b for detecting the current of the unit 310.
센서 스트립(110)의 측정 대상 전극부(210)와 헤마토크릿 전극부(310)는 전체적인 형상이 동일하고 전극의 배치 구조는 동일하며 시약(214, 314)이 마주하도록 포개져 조립되므로, 커넥터(120)의 단자들은, 도 5에 도시된 바와 같이, 좌측부터 측정 대상 전극부(210)의 작동 전극(212a)으로 전압을 인가하는 단자(510a), 측정 대상 전극부(210)의 기준 전극(212b)의 전류를 검출하는 단자(510b), 헤마토크릿 전극부(310)의 기준 전극(312b)의 전류를 검출하는 단자(511b) 그리고 헤마토크릿 전극부(310)의 작동 전극(312a)으로 전압을 인가하는 단자(511a)의 순서로 배치된다. Since the measurement target electrode 210 and the hematocrit electrode 310 of the sensor strip 110 have the same overall shape, the electrode arrangement structure is the same, and the reagents 214 and 314 are stacked and assembled to face each other, the connector 120 5, the terminals 510a for applying a voltage to the working electrode 212a of the electrode to be measured 210 from the left side, and the reference electrode 212b of the electrode to be measured 210 are measured. A voltage is applied to the terminal 510b for detecting the current of the electrode), the terminal 511b for detecting the current of the reference electrode 312b of the hematocrit electrode part 310 and the working electrode 312a of the hematocrit electrode part 310. It is arranged in the order of the terminals 511a.
이상의 실시예에서 설명한 바와 같이, 센서 스트립(110)의 측정 대상 전극부(210)와 헤마토크릿 전극부(310)는 전체적인 형상이 동일하고 전극의 배치 구조도 동일하며 시약(214, 314)이 소정의 간격으로 이격되어 마주하도록 포개져 조립되므로, 두 시약(214, 314)은 서로 섞이지 않는다. 즉, 종래에는 혈당을 측정하기 위한 시약과 헤마토크릿을 측정하기 위한 시약이 섞여 사용됨으로써, 일정한 혈당 농도 범위에서만 헤마토크릿 보정 효과를 볼 수 있는 반면, 본 발명의 실시예에 따르면, 혈당 측정을 위한 시약(214)과 헤마토크릿 측정을 위한 시약(314)이 서로 섞이지 않으면서 혈당 농도의 범위에 제한 없이 헤마토크릿의 간섭에 의한 혈당 농도 측정 값을 정확하게 보정할 수 있다. As described in the above embodiments, the measurement target electrode portion 210 and the hematocrit electrode portion 310 of the sensor strip 110 have the same overall shape, the arrangement structure of the electrodes, and the reagents 214 and 314 are predetermined. The two reagents 214 and 314 do not mix with each other because they are assembled to overlap each other, spaced apart. That is, in the related art, a reagent for measuring blood glucose and a reagent for measuring hematocrit are used in combination, whereby a hematocrit correction effect can be seen only at a predetermined blood sugar concentration range, whereas according to an embodiment of the present invention, a reagent for measuring blood glucose ( 214) and the reagent 314 for measuring the hematocrit can be accurately corrected by the interference of the hematocrit without limiting the range of the blood glucose concentration.
본 명세서는 많은 특징을 포함하는 반면, 그러한 특징은 본 발명의 범위 또는 특허청구범위를 제한하는 것으로 해석되어서는 안 된다. 또한, 본 명세서에서 개별적인 실시예에서 설명된 특징들은 단일 실시예에서 결합되어 구현될 수 있다. 반대로, 본 명세서에서 단일 실시예에서 설명된 다양한 특징들은 개별적으로 다양한 실시예에서 구현되거나, 적절히 결합되어 구현될 수 있다.While this specification contains many features, such features should not be construed as limiting the scope of the invention or the claims. Also, the features described in the individual embodiments herein can be implemented in combination in a single embodiment. Conversely, various features described in a single embodiment herein can be implemented individually in various embodiments or in combination as appropriate.
이상에서 설명한 본 발명은, 본 발명이 속하는 기술분야에서 통상의 지식을 가진 자에게 있어 본 발명의 기술적 사상을 벗어나지 않는 범위 내에서 여러 가지 치환, 변형 및 변경이 가능하므로 전술한 실시예 및 첨부된 도면에 의해 한정되는 것이 아니다.The present invention described above is capable of various substitutions, modifications, and changes without departing from the technical spirit of the present invention for those skilled in the art to which the present invention pertains. It is not limited by the drawings.

Claims (10)

  1. 혈액 내의 생체 물질을 측정하기 위한 센서 스트립으로서,A sensor strip for measuring a biomaterial in blood,
    제 1 절연 기판과, 상기 제 1 절연 기판 상에 소정 간격으로 이격되어 형성된 제 1, 2 전극과, 상기 제 1, 2 전극의 적어도 일부에 대응하는 부분에 슬릿이 형성되고 상기 제 1, 2 전극 위에 설치되는 제 1 스페이서 필름과, 상기 슬릿에 노출된 상기 제 1, 2 전극의 적어도 일부에 도포되는 제 1 시약을 포함하는 측정 대상 전극부; 및A slit is formed on a first insulating substrate, first and second electrodes spaced apart at predetermined intervals on the first insulating substrate, and portions corresponding to at least a portion of the first and second electrodes, and the first and second electrodes are formed. A measurement target electrode part including a first spacer film disposed thereon and a first reagent applied to at least a portion of the first and second electrodes exposed to the slit; And
    제 2 절연 기판과, 상기 제 2 절연 기판 상에 소정 간격으로 이격되어 형성된 제 3, 4 전극과, 상기 제 3, 4 전극의 적어도 일부에 대응하는 부분에 슬릿이 형성되고 상기 제 3, 4 전극 위에 설치되는 제 2 스페이서 필름과, 상기 제 2 스페이서 필름의 슬릿에 노출된 상기 제 3, 4 전극의 적어도 일부에 도포되는 제 2 시약을 포함하는 헤마토크릿 전극부;를 포함하고,Slit is formed in a second insulating substrate, the third and fourth electrodes spaced apart at predetermined intervals on the second insulating substrate, and portions corresponding to at least a portion of the third and fourth electrodes, and the third and fourth electrodes are formed. And a hematocrit electrode unit including a second spacer film disposed thereon and a second reagent applied to at least a portion of the third and fourth electrodes exposed to the slits of the second spacer film.
    상기 측정 대상 전극부의 제 1 시약과 상기 헤마토크릿 전극부의 제 2 시약이 소정 간격으로 이격되어 마주보도록 상기 측정 대상 전극부와 상기 헤마토크릿 전극부는 포개져 조립되는 것을 특징으로 하는 센서 스트립.The first and second reagents of the measurement target electrode portion and the hematocrit electrode portion of the sensor strip characterized in that the electrode assembly and the measurement target electrode portion is stacked and assembled so as to face each other.
  2. 제 1 항에 있어서,The method of claim 1,
    상기 측정 대상 전극부의 상기 제 1 시약의 도포 두께는 상기 제 1 스페이서 필름의 두께보다 작고, 상기 헤마토크릿 전극부의 상기 제 2 시약의 도포 두께는 상기 제 2 스페이서 필름의 두께보다 작음으로써, 상기 제 1, 2 시약 간의 소정 간격을 형성하는 것을 특징으로 하는 센서 스트립.The coating thickness of the first reagent of the measurement target electrode portion is smaller than the thickness of the first spacer film, and the coating thickness of the second reagent of the hematocrit electrode portion is smaller than the thickness of the second spacer film. A sensor strip, which forms a predetermined gap between two reagents.
  3. 제 1 항에 있어서,The method of claim 1,
    상기 제 1 시약과 상기 제 2 시약은, 동일한 혈액에 대해 동시에 반응하는 것을 특징으로 하는 센서 스트립.And the first reagent and the second reagent react simultaneously with the same blood.
  4. 제 3 항에 있어서,The method of claim 3, wherein
    상기 제 1 시약은, 혈액 내 혈당에 반응하는 시약이고, 상기 제 2 시약은 혈액 내 적혈구에 반응하는 시약인 것을 특징으로 하는 센서 스트립.Wherein said first reagent is a reagent that reacts to blood glucose in blood, and said second reagent is a reagent that reacts to red blood cells in blood.
  5. 제 1 항에 있어서,The method of claim 1,
    상기 측정 대상 전극부와 상기 헤마토크릿 전극부는, 상기 제 1, 2 시약의 종류가 상이하고 전극들의 배치 위치 및 전체 형상은 서로 동일한 것을 특징으로 하는 센서 스트립.The measurement target electrode portion and the hematocrit electrode portion, the type of the first and second reagents are different, the arrangement position and the overall shape of the electrodes, the sensor strip, characterized in that the same.
  6. 혈액 내의 생체 물질을 측정하기 위한 생체 물질 측정 장치에 있어서,In the biomaterial measuring apparatus for measuring a biomaterial in blood,
    상기 혈액에 반응하여 반응 신호를 출력하는 센서 스트립;A sensor strip that outputs a response signal in response to the blood;
    상기 센서 스트립에서 출력되는 상기 반응 신호를 분석하여 상기 혈액 내 특정 생체 물질의 농도를 측정하는 분석 장치; 및An analysis device for analyzing the reaction signal output from the sensor strip to measure a concentration of a specific biomaterial in the blood; And
    상기 센서 스트립과 상기 분석 장치를 연결하는 커넥터를 포함하고,A connector connecting the sensor strip and the analysis device,
    상기 센서 스트립은,The sensor strip,
    제 1 절연 기판과, 상기 제 1 절연 기판 상에 소정 간격으로 이격되어 형성된 제 1, 2 전극과, 상기 제 1, 2 전극의 적어도 일부에 대응하는 부분에 슬릿이 형성되고 상기 제 1, 2 전극 위에 설치되는 제 1 스페이서 필름과, 상기 슬릿에 노출된 상기 제 1, 2 전극의 적어도 일부에 도포되는 제 1 시약을 포함하는 측정 대상 전극부; 및A slit is formed on a first insulating substrate, first and second electrodes spaced apart at predetermined intervals on the first insulating substrate, and portions corresponding to at least a portion of the first and second electrodes, and the first and second electrodes are formed. A measurement target electrode part including a first spacer film disposed thereon and a first reagent applied to at least a portion of the first and second electrodes exposed to the slit; And
    제 2 절연 기판과, 상기 제 2 절연 기판 상에 소정 간격으로 이격되어 형성된 제 3, 4 전극과, 상기 제 3, 4 전극의 적어도 일부에 대응하는 부분에 슬릿이 형성되고 상기 제 3, 4 전극 위에 설치되는 제 2 스페이서 필름과, 상기 제 2 스페이서 필름의 슬릿에 노출된 상기 제 3, 4 전극의 적어도 일부에 도포되는 제 2 시약을 포함하는 헤마토크릿 전극부;를 포함하고,Slit is formed in a second insulating substrate, the third and fourth electrodes spaced apart at predetermined intervals on the second insulating substrate, and portions corresponding to at least a portion of the third and fourth electrodes, and the third and fourth electrodes are formed. And a hematocrit electrode unit including a second spacer film disposed thereon and a second reagent applied to at least a portion of the third and fourth electrodes exposed to the slits of the second spacer film.
    상기 측정 대상 전극부의 제 1 시약과 상기 헤마토크릿 전극부의 제 2 시약이 소정 간격으로 이격되어 마주보도록 상기 측정 대상 전극부와 상기 헤마토크릿 전극부는 포개져 조립되는 것을 특징으로 하는 생체 물질 측정 장치.And the first and second reagents of the hematocrit electrode unit are stacked and assembled to face each other at a predetermined interval to face the first reagent of the electrode unit and the hematocrit electrode unit.
  7. 제 6 항에 있어서,The method of claim 6,
    상기 측정 대상 전극부와 상기 헤마토크릿 전극부는 상기 제 1, 2 시약의 종류가 상이하고 전극들의 배치 위치 및 전체 형상은 서로 동일하고,The measurement target electrode portion and the hematocrit electrode portion are different in the kind of the first and second reagents, the position and the overall shape of the electrodes are the same,
    상기 제 1, 3 전극은, 작동 전극이고, 상기 제 2, 4 전극은 기준 전극인 것을 특징으로 하는 생체 물질 측정 장치.And said first and third electrodes are working electrodes, and said second and fourth electrodes are reference electrodes.
  8. 제 7 항에 있어서,The method of claim 7, wherein
    상기 커넥터는,The connector,
    상기 제 1 내지 4 전극 각각에 연결되는 단자들을 포함하되, 상기 제 1 전극으로 전압을 인가하는 단자, 상기 제 2 전극으로부터 전류를 검출하는 단자, 상기 제 4 전극으로부터 전류를 검출하는 단자, 상기 제 3 전극으로 전압을 인가하는 단자의 순서로 배치되는 것을 특징으로 하는 생체 물질 측정 장치.A terminal connected to each of the first to fourth electrodes, the terminal for applying a voltage to the first electrode, a terminal for detecting a current from the second electrode, a terminal for detecting a current from the fourth electrode, and the second terminal A biomaterial measuring apparatus, characterized in that arranged in the order of the terminal for applying a voltage to the three electrodes.
  9. 제 6 항에 있어서,The method of claim 6,
    상기 측정 대상 전극부의 상기 제 1 시약의 도포 두께는 상기 제 1 스페이서 필름의 두께보다 작고, 상기 헤마토크릿 전극부의 상기 제 2 시약의 도포 두께는 상기 제 2 스페이서 필름의 두께보다 작음으로써, 상기 제 1, 2 시약 간의 소정 간격을 형성하는 것을 특징으로 하는 생체 물질 측정 장치.The coating thickness of the first reagent of the measurement target electrode portion is smaller than the thickness of the first spacer film, and the coating thickness of the second reagent of the hematocrit electrode portion is smaller than the thickness of the second spacer film. A biological material measuring apparatus, characterized in that a predetermined interval is formed between two reagents.
  10. 제 6 항에 있어서,The method of claim 6,
    상기 제 1 시약과 상기 제 2 시약은, 동일한 혈액에 대해 동시에 반응하는 것을 특징으로 하는 생세 물질 측정 장치.And said first reagent and said second reagent react simultaneously with the same blood.
PCT/KR2018/006301 2017-06-02 2018-06-01 Sensor strip and biomaterial measuring device using same WO2018222005A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR20170068928 2017-06-02
KR10-2017-0068928 2017-06-02

Publications (1)

Publication Number Publication Date
WO2018222005A1 true WO2018222005A1 (en) 2018-12-06

Family

ID=64456027

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/KR2018/006301 WO2018222005A1 (en) 2017-06-02 2018-06-01 Sensor strip and biomaterial measuring device using same

Country Status (2)

Country Link
KR (2) KR102042749B1 (en)
WO (1) WO2018222005A1 (en)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110327059A (en) * 2019-08-05 2019-10-15 浙江大学 A kind of electrode and application for biological sensing examination
TWI803996B (en) * 2021-10-06 2023-06-01 立寶光電股份有限公司 Detecting test piece and electrode manufacturing method

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR100980316B1 (en) * 2009-12-09 2010-09-06 동진메디칼 주식회사 Strip having thermal compensating function and method for measuring blood sugar using it
KR20110074776A (en) * 2008-11-28 2011-07-01 파나소닉 주식회사 Sensor chip, biosensor system, method for measuring temperature of biological sample, method for measuring temperature of blood sample, and method for measuring concentration of analyte in blood sample
KR20130066841A (en) * 2011-12-13 2013-06-21 (주)미코바이오메드 Glycosylated hemoglobin sensor strip, glycosylated hemoglobin measurement device and method for glycosylated hemoglobin measurement
KR101597943B1 (en) * 2015-08-17 2016-02-25 휴먼플러스(주) Apparatus for simultaneous measuring of glucose and hematocrit
KR20160093451A (en) * 2015-01-29 2016-08-08 주식회사 케어이엔지 Sensor strip, strip connector and measuring apparatus having the same

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1776464B1 (en) * 2004-08-13 2009-10-07 Egomedical Technologies AG Analyte test system for determining the concentration of an analyte in a physiological or aqueous fluid
US9080196B2 (en) * 2012-09-28 2015-07-14 Cilag Gmbh International System and method for determining hematocrit insensitive glucose concentration
US9243276B2 (en) * 2013-08-29 2016-01-26 Lifescan Scotland Limited Method and system to determine hematocrit-insensitive glucose values in a fluid sample
US10309888B2 (en) * 2015-04-06 2019-06-04 Arkray, Inc. Biosensor comprising electrode for measuring hematocrit value

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20110074776A (en) * 2008-11-28 2011-07-01 파나소닉 주식회사 Sensor chip, biosensor system, method for measuring temperature of biological sample, method for measuring temperature of blood sample, and method for measuring concentration of analyte in blood sample
KR100980316B1 (en) * 2009-12-09 2010-09-06 동진메디칼 주식회사 Strip having thermal compensating function and method for measuring blood sugar using it
KR20130066841A (en) * 2011-12-13 2013-06-21 (주)미코바이오메드 Glycosylated hemoglobin sensor strip, glycosylated hemoglobin measurement device and method for glycosylated hemoglobin measurement
KR20160093451A (en) * 2015-01-29 2016-08-08 주식회사 케어이엔지 Sensor strip, strip connector and measuring apparatus having the same
KR101597943B1 (en) * 2015-08-17 2016-02-25 휴먼플러스(주) Apparatus for simultaneous measuring of glucose and hematocrit

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110327059A (en) * 2019-08-05 2019-10-15 浙江大学 A kind of electrode and application for biological sensing examination
CN110327059B (en) * 2019-08-05 2020-06-23 浙江大学 Electrode for biological sensitivity test and application
TWI803996B (en) * 2021-10-06 2023-06-01 立寶光電股份有限公司 Detecting test piece and electrode manufacturing method

Also Published As

Publication number Publication date
KR102042749B1 (en) 2019-11-27
KR102083979B1 (en) 2020-03-03
KR20180132560A (en) 2018-12-12
KR20190128119A (en) 2019-11-15

Similar Documents

Publication Publication Date Title
CN109613078B (en) Anti-interference electrochemical detection sensor and manufacturing method thereof
CN102565153B (en) Electrode type urine glucose testing strip with function of pretreating detected sample
WO2010044525A1 (en) Electrochemical biosensor structure and measuring method using the same
US9880128B2 (en) Electrode strip and sensor strip and manufacture method thereof and system thereof
CN103424451B (en) A kind of card form potassium ion sensor and preparation method thereof
US20150241378A1 (en) Electrochemical-based analytical test strip with bare interferent electrodes
JPH05164724A (en) Biosensor and method for separative quantification using the same
EP2284526B1 (en) Biosensor system and method of measuring analyte concentration in blood sample
CN104330448A (en) High-sensitivity electrode type uric acid test paper and manufacturing method thereof
WO2009120049A2 (en) Multichannel strip for a biosensor
CN103105426A (en) Urine glucose testing method and biosensor used in method
KR102083979B1 (en) Sensor strip and Apparatus for measuring biomaterial using the sensor strip
WO2021143730A1 (en) Electrochemical test strip for testing multiple indicators, and testing method thereof
US8512532B2 (en) Method of producing whole blood detecting electrode strip and reaction film formulation and the related products
CN108896635A (en) A kind of beta-hydroxybutyric acid electrochemical sensor
WO2017047856A1 (en) Biosensor strip and method of manufacturing same
EP2297574A1 (en) Bio-sensor
KR100611510B1 (en) Electrochemical biosensor test strip and reagent for analyzing physiological sample including blood corpuscles
WO2013133459A1 (en) Reagent composition for biosensors and biosensor comprising reagent layer formed of the same
CN208795691U (en) A kind of beta-hydroxybutyric acid electrochemical sensor
WO2020194179A1 (en) Biosensor for detection of analytes in a fluid
WO2022211221A1 (en) Sandwich enzyme-linked immunosorbent assay-based leptin biosensor, and method for detecting leptin by using same
WO2020116743A1 (en) Measurement method for electrochemical biosensor
KR100591246B1 (en) Electrochemical biosensor test strip
CN117604070A (en) Portable test strip for safely detecting hyperuricemia

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 18809433

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

32PN Ep: public notification in the ep bulletin as address of the adressee cannot be established

Free format text: NOTING OF LOSS OF RIGHTS PURSUANT TO RULE 112(1) EPC (EPO FORM 1205A DATED 13.03.2020)

122 Ep: pct application non-entry in european phase

Ref document number: 18809433

Country of ref document: EP

Kind code of ref document: A1