WO2022173267A1 - Bande pour biocapteur, son procédé de fabrication, et dispositif de collecte et de mesure de sang l'utilisant - Google Patents

Bande pour biocapteur, son procédé de fabrication, et dispositif de collecte et de mesure de sang l'utilisant Download PDF

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Publication number
WO2022173267A1
WO2022173267A1 PCT/KR2022/002190 KR2022002190W WO2022173267A1 WO 2022173267 A1 WO2022173267 A1 WO 2022173267A1 KR 2022002190 W KR2022002190 W KR 2022002190W WO 2022173267 A1 WO2022173267 A1 WO 2022173267A1
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WO
WIPO (PCT)
Prior art keywords
blood
specific component
biosensor
strip
unit
Prior art date
Application number
PCT/KR2022/002190
Other languages
English (en)
Korean (ko)
Inventor
이강원
문경환
배채원
Original Assignee
서울대학교산학협력단
주식회사 더도니
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.)
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Publication date
Application filed by 서울대학교산학협력단, 주식회사 더도니 filed Critical 서울대학교산학협력단
Publication of WO2022173267A1 publication Critical patent/WO2022173267A1/fr

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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
    • A61B5/1468—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
    • 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
    • A61B5/14532—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
    • A61B5/15—Devices for taking samples of blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150358—Strips for collecting blood, e.g. absorbent
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150755—Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/157—Devices characterised by integrated means for measuring characteristics of 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
    • G01N33/49—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
    • G01N33/49—Blood
    • G01N33/491—Blood by separating the blood components

Definitions

  • the present invention relates to a strip for a biosensor and a blood collection measuring device using the same, and more particularly, by modifying the structure of the biosensor strip to integrate the blood collection device and the biosensor strip so that the user needs to alternately use the blood collection device and the measuring device It relates to a strip for a biosensor capable of measuring a specific component in blood at once without the use of the same, and a blood collection measuring device using the same.
  • a biosensor refers to a system that converts a recognizable useful signal such as a color, fluorescence, or electrical signal by using a biological element obtained from a measurement target.
  • the biosensor is a futuristic fusion technology that requires technology across sciences such as electronics, chemistry, biology, materials engineering, and enzyme engineering.
  • Korean Utility Model No. 20-0448186 discloses a technology related to a multi-channel strip for a biosensor that includes a plurality of reaction units in one strip and enables analysis of a plurality of in vivo substances at once. is starting
  • Conventional techniques for detecting a specific component contained in blood using the above-described biosensor include a process of collecting blood by pricking a finger, introducing the collected blood into the biosensor, and analyzing the specific component contained in the blood.
  • the present invention provides a strip for a biosensor capable of increasing user convenience by integrating a strip of a blood collection device and a measuring device, and enabling rapid detection even when a small amount of blood is used, and a blood collection measuring device using the same aim to do
  • a strip for a biosensor for detecting a physical amount of a specific component contained in blood is provided.
  • a strip for a biosensor for detecting a physical amount of a specific component included in blood includes a hollow support wall in which blood is accommodated, and a specific component included in the blood by being formed on the support wall. It may include a sensing unit including an electrode for measuring a physical amount of , and a blood collection unit coupled to one end of the sensing unit and collecting blood from a user.
  • the sensing unit includes a substrate, a plurality of electrodes formed on the substrate, and a plurality of electrodes for measuring the physical quantity of the specific component It is provided on some of the electrodes of the electrode and may further include a selective permeable membrane that selectively transmits a specific component contained in the blood.
  • the sensing unit may further include a blood separation membrane provided on the electrode or the selective permeable membrane to separate the blood.
  • the electrode measures the physical quantity of the specific component in blood through which the specific component is not permeated by the selective permeable membrane It may further include a reference electrode, and a measuring electrode for measuring the physical amount of the specific component in the blood through which the specific component is permeated by the selective permeable membrane.
  • the blood collection unit is provided at the end of the blood collection unit, and the blood collection needle for exposing the user's body to the outside of the body and the blood It may further include an inlet hole for guiding the inflow into the sensing unit.
  • the strip for a biosensor for detecting a physical amount of a specific component included in blood may further include a support part inserted into the sensing part and coupled to one end of the blood collection part.
  • a blood collection measuring device using the above-described biosensor strip.
  • a blood collection measuring apparatus includes the above-described biosensor strip; a connection unit inserted into the biosensor strip and configured to receive a signal including information on the physical quantity of the specific component measured by the sensing unit; It may include a pressing part for moving the connection part up and down, and a housing provided with the connection part and the pressing part.
  • the blood collection measuring apparatus may further include a control unit for receiving the signal from the connection unit to calculate the physical quantity of the specific component, and a display unit for displaying the physical quantity of the specific component calculated by the control unit.
  • a method of manufacturing a strip for a biosensor for detecting a physical amount of a specific component contained in blood is provided.
  • a method for manufacturing a strip for a biosensor for detecting a physical quantity of a specific component contained in blood includes a substrate preparation step of preparing a substrate, and measuring the physical quantity of a specific component contained in blood on the substrate an electrode forming step of forming a plurality of electrodes to It may include a film forming step of forming a separation film, and a substrate processing step of processing the substrate to have a columnar shape by rolling it.
  • the present invention there is an advantage in that the amount of blood required for measurement and the measurement time can be reduced by simultaneously performing blood collection and measurement without a separate blood collection process.
  • FIG. 1 is a perspective view of a strip for a biosensor according to an embodiment of the present invention.
  • FIG. 2 is an exploded view and a cross-sectional view of a sensing unit of a strip for a biosensor according to an embodiment of the present invention.
  • FIG 3 is an exemplary view of a blood collection unit of a strip for a biosensor according to an embodiment of the present invention.
  • FIG. 4 is an exemplary view of a blood collection unit of a strip for a biosensor according to an embodiment of the present invention.
  • FIG 5 is an exemplary view of a blood collection unit of a strip for a biosensor according to an embodiment of the present invention.
  • FIG. 6 is an exemplary view of a support part of a strip for a biosensor according to an embodiment of the present invention.
  • FIG. 7 is a plan view of a blood collection device using a strip for a biosensor according to an embodiment of the present invention.
  • FIG. 8 is an overall configuration diagram of a blood collection device using a strip for a biosensor according to an embodiment of the present invention.
  • FIG. 9 is a flowchart of a method of manufacturing a strip for a biosensor according to an embodiment of the present invention.
  • a strip for a biosensor for detecting a physical amount of a specific component contained in blood is provided.
  • a strip for a biosensor for detecting a physical amount of a specific component included in blood includes a hollow support wall in which blood is accommodated, and a specific component included in the blood by being formed on the support wall. It may include a sensing unit including an electrode for measuring a physical amount of , and a blood collection unit coupled to one end of the sensing unit and collecting blood from a user.
  • the sensing unit may further include a blood separation membrane provided on the electrode or the selective permeable membrane to separate the blood.
  • the electrode measures the physical quantity of the specific component in blood through which the specific component is not permeated by the selective permeable membrane It may further include a reference electrode, and a measuring electrode for measuring the physical amount of the specific component in the blood through which the specific component is permeated by the selective permeable membrane.
  • the blood collection unit is provided at the end of the blood collection unit, and the blood collection needle for exposing the user's body to the outside of the body and the blood It may further include an inlet hole for guiding the inflow into the sensing unit.
  • the strip for a biosensor for detecting a physical amount of a specific component included in blood may further include a support part inserted into the sensing part and coupled to one end of the blood collection part.
  • a blood collection measuring device using the above-described biosensor strip.
  • a blood collection measuring apparatus includes the above-described biosensor strip; a connection unit inserted into the biosensor strip and configured to receive a signal including information on the physical quantity of the specific component measured by the sensing unit; It may include a pressing part for moving the connection part up and down, and a housing provided with the connection part and the pressing part.
  • the blood collection measuring apparatus may further include a control unit for receiving the signal from the connection unit to calculate the physical quantity of the specific component, and a display unit for displaying the physical quantity of the specific component calculated by the control unit.
  • a method of manufacturing a strip for a biosensor for detecting a physical amount of a specific component contained in blood is provided.
  • FIG. 1 is a perspective view of a strip 1000 for a biosensor according to an embodiment of the present invention.
  • a biosensor strip 1000 for detecting a physical amount of a specific component included in blood may include a sensing unit 1100 and a blood collection unit 1200 . .
  • the sensing unit 1100 may include a hollow support wall in which blood is accommodated, and an electrode 1120 formed on the support wall to measure a physical quantity of a specific component contained in blood.
  • the cross-section of the support wall may have various shapes, such as a circle, a triangle, and a square. However, it is not limited to the above-described example, and any shape that forms a space in which blood can be accommodated may be applied.
  • the sensing unit 1100 of the biosensor strip 1000 may include a substrate 1110 , an electrode 1120 , and a selective transmission film 1130 . can
  • the selective permeable membrane 1130 is provided on some of the electrodes 1120 among the plurality of electrodes 1120 and selectively transmits a specific component included in blood or reacts only with a specific component.
  • the electrode 1120 is specified by the reference electrode 1121 and the selective permeable membrane 1130 for measuring the physical quantity of a specific component in blood to which the specific component is not permeated by the selective permeable membrane 1130 . It may further include a measuring electrode 1122 for measuring a physical quantity of a specific component in the blood through which the component has passed.
  • a physical quantity of a specific component is calculated by detecting an electrical signal change such as a potential difference generated according to a difference in the physical quantity of a specific component between the reference electrode 1121 and the measuring electrode 1122 .
  • the material transmitted by the selective permeable membrane 1130 may be a specific component included in the blood
  • the material separated by the blood separation membrane 1140 may be a large-sized material such as white blood cells or red blood cells in the blood.
  • the blood collection unit 1200 includes a needle 1210 and an inlet hole. (1220).
  • the blood collection needle 1210 is a configuration for exposing the user's body to the outside of the body, and is formed at the end of the blood collection unit 1200 and may be formed to have a pointed shape or formed by attaching a needle.
  • the blood collection unit 1200 may further include a transfer path 1230 so that the blood exposed outside the user's body flows into the sensing unit 1100 through the inlet hole 1220 .
  • the strip 1000 for a biosensor for detecting a physical amount of a specific component included in blood may further include a support unit 1300 .
  • the support unit 1300 is configured to have a sensing unit 1100 inserted therein, and is coupled to one end of the blood collection unit 1200 .
  • the support unit 1300 serves to protect the sensing unit 1100 so that the sensing unit 1100 is not damaged by a physical force generated in the sensing unit 1100 when the blood collection unit 1200 applies a force to the user's skin.
  • FIG. 7 is a plan view of a blood collection apparatus and a measuring apparatus using the biosensor strip 1000 according to an embodiment of the present invention
  • FIG. 8 is a blood collection using the biosensor strip 1000 according to an embodiment of the present invention. It is the overall configuration diagram of the device and the measuring device.
  • the blood collection device and the measuring device include the biosensor strip 1000 , the connection part 2000 , the pressing part 3000 , and the housing 4000 . may include
  • connection part 2000 is a configuration that is inserted into the biosensor strip 1000 and connects the biosensor strip 1000 and the pressing part 3000 .
  • the connection unit 2000 receives a signal including information on a physical quantity of a specific component measured by the sensing unit 1100 , and transmits the received signal to the control unit.
  • the housing 4000 may include a connection part 2000 and a pressing part 3000 .
  • the blood collection measuring apparatus may further include a control unit and a display unit 5000 .
  • the control unit may be implemented as a circuit board 1110 accommodated in the housing 4000 , and the display unit 5000 may be provided outside the housing 4000 .
  • the control unit may receive a signal from the connection unit 2000 and calculate a physical quantity of a specific component.
  • the description is omitted since the same technique as the conventional technique can be applied.
  • the display unit 5000 may provide information on the specific component to the user by displaying the physical quantity of the specific component calculated by the control unit.
  • the information on the specific component provided through the display unit 5000 may relate to the concentration, amount, and rate of change of the specific component.
  • FIG. 9 is a flowchart of a method of manufacturing a strip 1000 for a biosensor according to an embodiment of the present invention.
  • the method for manufacturing a strip 1000 for a biosensor for detecting a physical amount of a specific component included in blood includes a substrate preparation step (S100) and an electrode forming step (S200). , a film forming step (S300) and a substrate processing step (S400) may be included.
  • the substrate 1110 is prepared.
  • the substrate 1110 may be made of a material such as glass, silicon, or polymer, and an appropriate substrate 1110 may be selected according to the type of a specific component.
  • a plurality of electrodes 1120 for measuring the physical amount of a specific component included in blood are formed on the substrate 1110 .
  • it may be formed by printing on the substrate 1110 using ink composed of carbon or platinum-treated carbon, and may be formed by vacuum deposition using gold.
  • a selective permeation membrane 1130 or blood that selectively transmits a specific component included in blood or reacts only with the specific component on some of the electrodes 1120 of the plurality of electrodes 1120 A blood separation membrane 1140 to separate is formed.
  • the type of the selective transmission film 1130 formed according to the type of the electrode 1120 or the type of a specific component to be measured may be selected differently.
  • a selectively permeable membrane 1130 that selectively transmits blood glucose or reacts only with blood glucose is formed only on the measuring electrode 1122, and a reference electrode 1121 and a selective permeable membrane 1130 are formed on the measuring electrode
  • a blood separation membrane 1140 for separating plasma from blood may be formed on the 1122 .
  • the material transmitted by the selective permeable membrane 1130 may be a specific component included in the blood
  • the material separated by the blood separation membrane 1140 may be a large-sized material such as white blood cells or red blood cells in the blood.
  • the substrate 1110 is rolled and processed to have a columnar shape. That is, the substrate 1110 according to the present invention has a shape in which the substrate 1110 itself can receive blood through the substrate processing step (S400).

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Abstract

La présente invention concerne une bande pour un biocapteur et un dispositif de collecte et de mesure de sang l'utilisant et, plus spécifiquement, une bande pour un biocapteur, dont la structure est transformée pour intégrer un dispositif de mesure du sang avec celle-ci, de telle sorte qu'un utilisateur peut mesurer un composant spécifique dans le sang en une seule fois sans avoir besoin d'utiliser en alternance un dispositif autopiqueur et un dispositif de mesure, et un dispositif de collecte et de mesure de sang l'utilisant. Une bande pour un biocapteur pour détecter la quantité physique d'un composant spécifique contenu dans le sang selon un mode de réalisation de la présente invention comprend : une paroi de support creuse dans laquelle du sang est logé ; une unité de détection formée sur la paroi de support et comprenant une électrode pour mesurer la quantité physique d'un composant spécifique contenu dans le sang ; et une unité de collecte de sang couplée à une extrémité de l'unité de détection et collectant du sang auprès d'un utilisateur.
PCT/KR2022/002190 2021-02-15 2022-02-15 Bande pour biocapteur, son procédé de fabrication, et dispositif de collecte et de mesure de sang l'utilisant WO2022173267A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR1020210019705A KR20220116633A (ko) 2021-02-15 2021-02-15 바이오 센서용 스트립과 그 제작방법 및 이를 이용한 채혈 측정 장치
KR10-2021-0019705 2021-02-15

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KR102632320B1 (ko) * 2021-10-19 2024-02-02 단국대학교 천안캠퍼스 산학협력단 간질액의 추출 및 진단용 장치

Citations (5)

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Publication number Priority date Publication date Assignee Title
JP2009544407A (ja) * 2006-07-25 2009-12-17 メドトロニック ミニメド インコーポレイテッド 分析物センサならびにその製造および使用方法
KR20110001862U (ko) * 2009-08-18 2011-02-24 홍종수 말초 혈액 검사기용 스트립 센서
KR20120013436A (ko) * 2009-07-10 2012-02-14 에프. 호프만-라 로슈 아게 란셋
KR20130044817A (ko) * 2011-10-25 2013-05-03 주식회사 세라젬메디시스 바이오센서 및 그 제조 방법
KR20200004164A (ko) * 2018-07-03 2020-01-13 광운대학교 산학협력단 제조공정이 단순화된 최소 침습형 니들 기반 바이오센서 및 그 제조방법

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR200448186Y1 (ko) 2008-03-28 2010-03-24 한국생명공학연구원 바이오센서용 다채널 스트립

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2009544407A (ja) * 2006-07-25 2009-12-17 メドトロニック ミニメド インコーポレイテッド 分析物センサならびにその製造および使用方法
KR20120013436A (ko) * 2009-07-10 2012-02-14 에프. 호프만-라 로슈 아게 란셋
KR20110001862U (ko) * 2009-08-18 2011-02-24 홍종수 말초 혈액 검사기용 스트립 센서
KR20130044817A (ko) * 2011-10-25 2013-05-03 주식회사 세라젬메디시스 바이오센서 및 그 제조 방법
KR20200004164A (ko) * 2018-07-03 2020-01-13 광운대학교 산학협력단 제조공정이 단순화된 최소 침습형 니들 기반 바이오센서 및 그 제조방법

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