CA2346415A1 - Small volume in vitro analyte sensor with diffusible or non-leachable redox mediator - Google Patents

Small volume in vitro analyte sensor with diffusible or non-leachable redox mediator Download PDF

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Publication number
CA2346415A1
CA2346415A1 CA002346415A CA2346415A CA2346415A1 CA 2346415 A1 CA2346415 A1 CA 2346415A1 CA 002346415 A CA002346415 A CA 002346415A CA 2346415 A CA2346415 A CA 2346415A CA 2346415 A1 CA2346415 A1 CA 2346415A1
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CA
Canada
Prior art keywords
sensor
diffusible
redox mediator
leachable
small volume
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.)
Granted
Application number
CA002346415A
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French (fr)
Other versions
CA2346415C (en
Inventor
Benjamin J. Feldman
Adam Heller
Ephraim Heller
Fei Mao
Joseph A. Vivolo
Jeffery V. Funderburk
Fredric C. Colman
Rajesh Krishnan
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.)
Abbott Diabetes Care Inc
Original Assignee
Therasense, Inc.
Benjamin J. Feldman
Adam Heller
Ephraim Heller
Fei Mao
Joseph A. Vivolo
Jeffery V. Funderburk
Fredric C. Colman
Rajesh Krishnan
Abbott Diabetes Care Inc
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Filing date
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Application filed by Therasense, Inc., Benjamin J. Feldman, Adam Heller, Ephraim Heller, Fei Mao, Joseph A. Vivolo, Jeffery V. Funderburk, Fredric C. Colman, Rajesh Krishnan, Abbott Diabetes Care Inc filed Critical Therasense, Inc.
Publication of CA2346415A1 publication Critical patent/CA2346415A1/en
Application granted granted Critical
Publication of CA2346415C publication Critical patent/CA2346415C/en
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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N27/00Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
    • G01N27/26Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
    • G01N27/28Electrolytic cell components
    • G01N27/30Electrodes, e.g. test electrodes; Half-cells
    • G01N27/327Biochemical electrodes, e.g. electrical or mechanical details for in vitro measurements
    • G01N27/3271Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood
    • G01N27/3272Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12QMEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12QMEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/001Enzyme electrodes
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12QMEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/001Enzyme electrodes
    • C12Q1/005Enzyme electrodes involving specific analytes or enzymes
    • C12Q1/006Enzyme electrodes involving specific analytes or enzymes for glucose
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12QMEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/26Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving oxidoreductase
    • C12Q1/32Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving oxidoreductase involving dehydrogenase
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N27/00Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
    • G01N27/26Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
    • G01N27/28Electrolytic cell components
    • G01N27/30Electrodes, e.g. test electrodes; Half-cells
    • G01N27/327Biochemical electrodes, e.g. electrical or mechanical details for in vitro measurements
    • G01N27/3271Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N27/00Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
    • G01N27/26Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
    • G01N27/28Electrolytic cell components
    • G01N27/30Electrodes, e.g. test electrodes; Half-cells
    • G01N27/327Biochemical electrodes, e.g. electrical or mechanical details for in vitro measurements
    • G01N27/3271Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood
    • G01N27/3274Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
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    • Y10T156/00Adhesive bonding and miscellaneous chemical manufacture
    • Y10T156/10Methods of surface bonding and/or assembly therefor
    • Y10T156/1052Methods of surface bonding and/or assembly therefor with cutting, punching, tearing or severing
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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    • Y10T29/49117Conductor or circuit manufacturing
    • Y10T29/49124On flat or curved insulated base, e.g., printed circuit, etc.
    • Y10T29/49126Assembling bases
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    • Y10T29/49124On flat or curved insulated base, e.g., printed circuit, etc.
    • Y10T29/49128Assembling formed circuit to base
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    • Y10T29/49124On flat or curved insulated base, e.g., printed circuit, etc.
    • Y10T29/4913Assembling to base an electrical component, e.g., capacitor, etc.
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    • Y10T29/49155Manufacturing circuit on or in base
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    • Y10T29/49794Dividing on common outline

Abstract

A sensor utilizing a non-leachable or diffusible redox mediator is described . The sensor includes a sample chamber to hold a sample in electrolytic contac t with a working electrode, and in at least some instances, the sensor also contains a non-leachable or a diffusible second electron transfer agent. The sensor and/or the methods used produce a sensor signal in response to the analyte that can be distinguished from a background signal caused by the mediator. The invention can be used to determine the concentration of a biomolecule, such as glucose or lactate, in a biological fluid, such as bloo d or serum, using techniques such as coulometry, amperometry, and potentiometr y. An enzyme capable of catalyzing the electrooxidation or electroreduction of the biomolecule is typically provided as a second electron transfer agent.</ SDOAB>
CA002346415A 1998-10-08 1999-10-08 Small volume in vitro analyte sensor with diffusible or non-leachable redox mediator Expired - Lifetime CA2346415C (en)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US10362798P 1998-10-08 1998-10-08
US10577398P 1998-10-08 1998-10-08
US60/105,773 1998-10-08
US60/103,627 1998-10-08
US09/295,962 1999-04-21
US09/295,962 US6338790B1 (en) 1998-10-08 1999-04-21 Small volume in vitro analyte sensor with diffusible or non-leachable redox mediator
PCT/US1999/023425 WO2000020626A1 (en) 1998-10-08 1999-10-08 Small volume in vitro analyte sensor with diffusible or non-leachable redox mediator

Publications (2)

Publication Number Publication Date
CA2346415A1 true CA2346415A1 (en) 2000-04-13
CA2346415C CA2346415C (en) 2007-08-28

Family

ID=27379577

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002346415A Expired - Lifetime CA2346415C (en) 1998-10-08 1999-10-08 Small volume in vitro analyte sensor with diffusible or non-leachable redox mediator

Country Status (12)

Country Link
US (55) US6338790B1 (en)
EP (1) EP1119637B2 (en)
JP (1) JP3553884B2 (en)
KR (1) KR100446497B1 (en)
CN (2) CN101368926B (en)
AT (1) ATE262591T1 (en)
AU (1) AU765872B2 (en)
CA (1) CA2346415C (en)
DE (1) DE69915850T3 (en)
DK (1) DK1119637T4 (en)
ES (1) ES2223185T5 (en)
WO (1) WO2000020626A1 (en)

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