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WO2012060483A1 - Bande de biocapteur et lecteur de bande - Google Patents

Bande de biocapteur et lecteur de bande Download PDF

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Publication number
WO2012060483A1
WO2012060483A1 PCT/KR2010/007660 KR2010007660W WO2012060483A1 WO 2012060483 A1 WO2012060483 A1 WO 2012060483A1 KR 2010007660 W KR2010007660 W KR 2010007660W WO 2012060483 A1 WO2012060483 A1 WO 2012060483A1
Authority
WO
WIPO (PCT)
Prior art keywords
membrane
strip
biosensor
bio sample
electric signal
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/KR2010/007660
Other languages
English (en)
Inventor
Jungsun Han
Gueisam Lim
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
LG Electronics Inc
Original Assignee
LG Electronics Inc
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 LG Electronics Inc filed Critical LG Electronics Inc
Priority to PCT/KR2010/007660 priority Critical patent/WO2012060483A1/fr
Publication of WO2012060483A1 publication Critical patent/WO2012060483A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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 or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/1468—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means
    • A61B5/1477—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means non-invasive
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
    • G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
    • G01N27/28—Electrolytic cell components
    • G01N27/30—Electrodes, e.g. test electrodes; Half-cells
    • G01N27/327—Biochemical electrodes, e.g. electrical or mechanical details for in vitro measurements
    • G01N27/3271—Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood
    • G01N27/3272—Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0295—Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157

Definitions

  • the present disclosure relates to an analysis strip for analyzing causes of diseases within body fluids for a diagnosis of patients, and a strip reader.
  • diagnosis of a state of health for patients is achieved by a mechanism of analyzing a patient’s bio sample, for example, body fluids to measure an amount or concentration of a substance (hereinafter, referred to as an indicative substance (marker, indicator )) related to diseases existing within the body fluids or the state of the patient’s health such as pregnancy.
  • an indicative substance hereinafter, referred to as an indicative substance (marker, indicator )
  • the measurement for the indicative substance is performed through a biochemical reaction, such as an oxidation-reduction reaction with respect to an indicator within body fluids taken from a patient.
  • quantitative or qualitative analysis for an analysis substance existing within a bio sample is important both in a chemical aspect and in a clinical aspect.
  • representative examples include measurement of a blood sugar level within blood for diabetic patients, measurement of cholesterol causing various adult diseases, and the like.
  • the POCT is a test for diagnosing a patient within a short time by immediately taking and analyzing body fluids directly at a place where the patient is.
  • the POCT is a simplified method, so it has various advantages, such as a patient’s self-diagnosis, reduction of additional expenses and time and the like. Consequently, the POCT is being widely used.
  • the POCT has been enabled by development of a biosensor.
  • the biosensors may be divided into an electrochemical type, an optic (LED, PD) type or a fluorescent type.
  • an electrochemical biosensor using enzyme activities is used for measuring a specific substance present within a bio sample (hereinafter, referred to as ‘specimen’), for example, used in a clinical chemical test for measuring glucose, uric acid, protein, DNA and cyclose.
  • a biosensor for measuring a concentration of glucose within blood has been concerned the most by several hundreds of diabetic patients and patients having potential for suffering from diabetes.
  • An electrochemical biosensor of various types of biosensors for measurement of blood sugar may be produced in a form of enzyme electrode, which includes oxidase having glucose as a matrix, for example, glucose oxidase, and an electron transfer mediator, which serves to transfer electrons generated by oxidation-reduction reaction between glucose and enzyme within blood to the electrode surface.
  • oxidase having glucose as a matrix for example, glucose oxidase
  • electron transfer mediator which serves to transfer electrons generated by oxidation-reduction reaction between glucose and enzyme within blood to the electrode surface.
  • Glucose oxidase, glucose dehydrogenase and the like are used as the oxidase.
  • Ferrocene, ferrocene-derivative, potassium ferricyanide, quinone, quinone-derivative, metal-compound and the like are widely used as the electron transfer mediator.
  • the electron transfer mediator (reduction state) is diffused up to an electrode surface of a strip.
  • a current which is generated by applying an oxidation potential of the electron transfer mediator in the reduction state at a surface of a working electrode, is measured so as to measure a concentration of blood sugar.
  • the electrochemical biosensor may reduce the influence of oxygen and be capable of using a sample without any pre-treatment even if the sample is opaque.
  • strip type biosensors which have been developed so far, can be used for only one kind of measurement.
  • a user should be equipped with various types of strips, resulting in user’s inconvenience.
  • it is difficult to discriminate each type of strip, thereby causing a user to be in trouble upon performing a measurement that the user wants.
  • one exemplary embodiment of the present disclosure is to address the problems, and more particularly, to perform various types of measurements.
  • a biosensor strip including a biosensor strip including a first membrane chemically reacting with a bio sample, a second membrane located below the first membrane and configured to generate an electric signal using a chemical reaction with the bio sample, electrodes by being in contact with the second membrane and configured to transfer the generated electric signal to a strip reader, and a separator interposed between the first membrane and the second membrane, and configured to control an amount of the bio sample flowing from the first membrane to the second membrane.
  • the first membrane may filter off particles larger than a predetermined size from the bio sample.
  • the biosensor strip may further include a third membrane located below the second membrane and configured to generate an electric signal by a chemical reaction with the bio sample, and electrodes being in contact with the third membrane and configured to transfer the electric signal to the strip reader.
  • the second membrane may be provided in plurality, and the plurality of second membranes may be arranged in a lengthwise direction of the first membrane.
  • the separator may be made of polyethylene. Also, the separator may include a plurality of holes for allowing the bio sample to move into the second membrane. The separator may filter off particles larger than a predetermined size from the bio sample.
  • a biosensor including a biosensor strip provided with a first membrane chemically reacting with a bio sample, a second membrane located below the first membrane and configured to generate an electric signal using a chemical reaction with the bio sample, electrodes being in contact with the second membrane and configured to transfer the generated electric signal to a strip reader, and a separator interposed between the first membrane and the second membrane, and configured to control an amount of the bio sample flowing from the first membrane to the second membrane, and a strip reader provided with an insertion unit in which the biosensor strip is inserted, a connector contactable with the electrodes, and a measurement unit configured to perform measurements of the bio sample according to the electric signal from the electrodes.
  • the strip reader may include a light emitting element for emitting light to a lower surface of the second membrane, and a light receiving element for receiving reflected light.
  • various types of measurements can be simultaneously performed at one time. Also, according to the strip, the user does not have to be equipped with various types of strips, resulting in reduction of user’s inconvenience and giving gains in a financial aspect.
  • FIG. 1 is an exemplary view of a biosensor strip reader in accordance with one exemplary embodiment
  • FIG. 2 is an exemplary view showing a configuration of the strip reader shown in FIG. 1;
  • FIG. 3 is a detailed exemplary view of the biosensor strip shown in FIG. 1;
  • FIG. 4 is an exemplary view showing a structure of the strip shown in FIG. 3 in accordance with one exemplary embodiment
  • FIG. 5 is an exemplary view showing a structure of the strip shown in FIG. 3 in accordance with another exemplary embodiment
  • FIG. 6 is an exemplary view showing a structure of the strip shown in FIG. 3 in accordance with another exemplary embodiment.
  • FIG. 7 is an exemplary view showing a structure of the strip shown in FIG. 3 in accordance with another exemplary embodiment.
  • FIG. 1 is an exemplary view showing a biosensor strip reader in accordance with one embodiment
  • FIG. 2 is an exemplary view showing a configuration of the strip reader shown in FIG. 1
  • FIG. 3 is a detailed exemplary view of the biosensor strip shown in FIG. 1.
  • a strip reader 200 may perform a component measurement (for example, measurement of blood sugar) of a specimen by virtue of a biosensor strip 100, and display the measurement result on a display unit.
  • a component measurement for example, measurement of blood sugar
  • the strip reader 200 may externally include an insertion unit in which the biosensor strip 100 is inserted, a display unit and an audio generator.
  • the strip reader 200 may internally include a connector 210 present within the insertion unit and connected to an electrode unit of the biosensor strip 100, and a measurement unit 220 configured to perform component measurements. Also, the strip reader 200 may include a display unit 230, an audio generator 240, a memory 250 and a controller 260.
  • the measurement unit 220 may include an electron measurement performing unit for performing an electronic measurement by receiving an electric signal sent from the electrode unit of the strip via the connector 210, and an optical measurement performing unit for performing an optical or fluorescent measurement.
  • the optical measurement performing unit may include a light emitting element (for example, light emitting diode (LED)) and a light receiving element (for example, photo diode (PD)).
  • the light emitting element may include at least one light emitting diode (e.g., LEDs) all integrated within a narrow space.
  • the light emitting diodes may emit, for example, red, blue and green colored light, or white, red, blue and green colored light. Alternatively, the light emitting diode may emit infrared rays.
  • the controller 260 may display a numerical value measured by the measurement unit on the display unit 230.
  • the controller 260 may also generate a sound (audio signal) via the audio generator 240 when the strip 100 is completely inserted into the insertion unit, and generate another sound when the measurement is completed.
  • a reaction unit 120 which generates an electric signal through a chemical reaction or a physical variation, may be present on one surface of the biosensor strip 100.
  • the electrode unit 110 for transferring the electric signal may be formed on one surface of the biosensor strip 100.
  • an accommodation portion for accommodating a bio sample (specimen), for example, serum, body fluids or the like, may be formed in one surface of the biosensor strip 100.
  • a specimen inlet may be formed at a lower side of the accommodation portion. The specimen inlet may allow the specimen to be fast introduced into the reaction unit 120.
  • precious metals e.g., gold, palladium, platinum and the like
  • carbon are generally used as an electrode material.
  • the precious metals and the carbon have high electrical conductivities, are rarely denatured and facilitate signal acquisition.
  • the electrode material may be coated in various manners, for example, screen printing, sputtering, plating and the like, upon forming electrodes on an insulation substrate, such as a plastic film.
  • FIG. 4 is an exemplary view showing a structure of the strip shown in FIG. 3 in accordance with one exemplary embodiment.
  • the reaction unit of the biosensor strip 100 may be formed by stacking two or more thin films, for example, membranes.
  • Electrodes may be interposed between the two membranes.
  • the upper first membrane may be configured to filter off a bio sample (specimen), for example, whole blood. That is, the upper first membrane may filter off a substance composed of large particles, such as red blood corpuscles, from the whole blood.
  • the lower second membrane may physically or chemically react with the specimen and generate an electric signal to transmit to the electrodes.
  • a principle of measuring blood sugar may be described as follows.
  • GOx denotes glucose oxidase
  • GOx-FAD and GOx-FADH2 respectively denote an oxidation state and a reduction state of flavin adenine dinucleotide (FAD), an active portion of the glucose oxidase.
  • FAD flavin adenine dinucleotide
  • the electrochemical biosensor may utilize, as the electron transfer mediator, ferrocene, ferrocene derivatives, quinones, quinone derivatives, transition metal-containing organic or inorganic substances (hexamine ruthenium, osmium-containing polymers, potassium ferricyanide, etc), organic conducting salts, electron transfer organic substances, such as viologen, and the like.
  • Glucose is oxidized into gluconate by a catalysis of glucose oxidase.
  • FAD as an active portion of the glucose oxidase is reduced into FADH2.
  • the reduced FADH2 is then oxidized into FAD and the electron transfer mediator is reduced, through oxidation-reduction reaction between FAD and the electron transfer mediator.
  • the electron transfer mediator in the reduction state is diffused up to the surfaces of the electrons.
  • a current which is generated by applying an oxidation potential of the electron transfer mediator in the reduction state at surfaces of working electrons, is measured, thereby measuring a concentration of blood sugar.
  • the first or second membrane includes a reaction reagent layer.
  • the reaction reagent layer may include oxidase, such as glucose oxidase, lactate oxidase and the like, an electron transfer mediator, water-soluble polymers, such as cellulose acetate, polyvinyl alcohol, polypyrrole and the like, fatty acid having 4 ⁇ 20 carbon in number as reagents for reduction of hematocrit effect, and oleophilic quaternary ammonium.
  • a reaction layer which reacts with light emitted from the light emitting element may be provided below the second membrane.
  • the light emitting element as aforementioned, may emit red, blue and/or green colored light.
  • a reaction mechanism with the light will be described as follows.
  • a reaction mechanism between alanine aminotransferase and light will be expressed according to Chemical Equation 5.
  • reaction color may depend on chromogen, but a representative dye type of ⁇ max(nm) value will be described as follows.
  • the light receiving element may read out a level of color change from the reflected light.
  • FIG. 5 is an exemplary view showing a structure of the strip shown in FIG. 3 in accordance with another exemplary embodiment.
  • a separator may be formed between the two membranes.
  • the separator may be made of polyethylene.
  • the separator may prevent a reagent of the upper first membrane, which is melted by whole blood, from being introduced into the second membrane. Also, the separator may perform filtering of large particles from the whole blood. To this end, the separator may include a plurality of fine holes.
  • a bio sample for example, whole blood is injected into the upper first membrane
  • relatively large particles such as red blood corpuscles
  • small particles flow downwardly.
  • Slightly larger particles of the small particles are filtered off by the separator again, and minute particles flow to the second membrane via the separator.
  • the minute particles make a physical or chemical reaction.
  • the electrodes may measure glucose, cholesterols, CK-MB and the like
  • the second membrane may measure TC, TG, HDL, AST, ALT and the like.
  • FIG. 6 is an exemplary view showing a structure of the strip shown in FIG. 3 in accordance with another exemplary embodiment.
  • a plurality of second membranes may be provided.
  • a plurality of electrode pairs are present below the first membrane, and the second membrane may be present below each electrode pair.
  • a separator may be disposed between an electrode pair and the lower second membrane.
  • pressure is applied onto the first membrane to render the first membrane contacted by the electrodes, whereby the whole blood can easily flows into the second membrane.
  • FIG. 7 is an exemplary view showing a structure of the strip shown in FIG. 3 in accordance with another exemplary embodiment.
  • a plurality membranes may be arranged in a perpendicular direction.
  • each membrane may be provided with holes which allow movement of blood to a lower membrane.
  • the separator may be interposed between the membranes.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Physics & Mathematics (AREA)
  • General Health & Medical Sciences (AREA)
  • Biophysics (AREA)
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  • Molecular Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Physics & Mathematics (AREA)
  • Biomedical Technology (AREA)
  • Analytical Chemistry (AREA)
  • Electrochemistry (AREA)
  • Immunology (AREA)
  • Hematology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Optics & Photonics (AREA)
  • Engineering & Computer Science (AREA)
  • Biochemistry (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Investigating Or Analysing Materials By The Use Of Chemical Reactions (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

Conformément à un mode de réalisation à titre d'exemple, l'invention porte sur une bande de biocapteur qui comprend une première membrane réagissant chimiquement avec un échantillon biologique, une seconde membrane située au-dessous de la première membrane et configurée pour générer un signal électrique par une réaction chimique avec l'échantillon biologique, des électrodes configurées pour transférer le signal électrique généré à un lecteur de bande en les emmenant en contact avec la seconde membrane, et un séparateur interposé entre la première membrane et la seconde membrane, et configuré pour contrôler une quantité de l'échantillon biologique s'écoulant de la première membrane à la seconde membrane.
PCT/KR2010/007660 2010-11-02 2010-11-02 Bande de biocapteur et lecteur de bande Ceased WO2012060483A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/KR2010/007660 WO2012060483A1 (fr) 2010-11-02 2010-11-02 Bande de biocapteur et lecteur de bande

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/KR2010/007660 WO2012060483A1 (fr) 2010-11-02 2010-11-02 Bande de biocapteur et lecteur de bande

Publications (1)

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WO2012060483A1 true WO2012060483A1 (fr) 2012-05-10

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6923894B2 (en) * 1999-11-11 2005-08-02 Apex Biotechnology Corporation Biosensor with multiple sampling ways
US20080314745A1 (en) * 2007-04-17 2008-12-25 Tesa Ag Biosensor and its production
US20090223834A1 (en) * 2001-07-31 2009-09-10 Nova Biomedical Corporation Biosensor and method
US20100025239A1 (en) * 2008-08-01 2010-02-04 Biomedix Taiwan Co., Ltd. Biosensor

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6923894B2 (en) * 1999-11-11 2005-08-02 Apex Biotechnology Corporation Biosensor with multiple sampling ways
US20090223834A1 (en) * 2001-07-31 2009-09-10 Nova Biomedical Corporation Biosensor and method
US20080314745A1 (en) * 2007-04-17 2008-12-25 Tesa Ag Biosensor and its production
US20100025239A1 (en) * 2008-08-01 2010-02-04 Biomedix Taiwan Co., Ltd. Biosensor

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