DK2126555T3 - Fremgangsmåde til drift af en elektrokemisk analytsensor - Google Patents
Fremgangsmåde til drift af en elektrokemisk analytsensor Download PDFInfo
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- DK2126555T3 DK2126555T3 DK08707817.6T DK08707817T DK2126555T3 DK 2126555 T3 DK2126555 T3 DK 2126555T3 DK 08707817 T DK08707817 T DK 08707817T DK 2126555 T3 DK2126555 T3 DK 2126555T3
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Classifications
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- G—PHYSICS
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- G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
- G01N27/02—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating impedance
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- 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
- G01N27/3274—Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
- A61B5/14532—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 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 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
- A61B5/1486—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 using enzyme electrodes, e.g. with immobilised oxidase
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—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
- A61B5/1495—Calibrating or testing of in-vivo probes
-
- 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
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/66—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood sugars, e.g. galactose
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
- A61B5/14503—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 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Physics & Mathematics (AREA)
- Molecular Biology (AREA)
- Chemical & Material Sciences (AREA)
- Pathology (AREA)
- General Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
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- Biotechnology (AREA)
- Cell Biology (AREA)
- Microbiology (AREA)
- Diabetes (AREA)
- Food Science & Technology (AREA)
- Medicinal Chemistry (AREA)
- Investigating Or Analyzing Materials By The Use Of Electric Means (AREA)
- Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
- Secondary Cells (AREA)
Claims (18)
1. Fremgangsmåde til drift af en elektrokemisk analytsensor (10) med en eller flere elektroder (24, 28, 32) til anvendelse i in vivo-målinger, hvilken fremgangsmåde omfatter: • påtrykning af et tidsvarierende indgangssignal på mindst en af den ene eller de flere elektroder (24,28,32), • overvågning af et tidsvarierende udgangssignal, der frembringes af sensoren (10) som respons på påtrykningen af det tidsvarierende indgangssignal, • bestemmelse af en kompleks impedans af sensoren (10) baseret på de tidsvarierende indgangs-og udgangssignaler og • bestemmelse af information vedrørende driften af sensoren (10) ud fra den komplekse impedans, hvor bestemmelsen af information vedrørende driften af sensoren (10) ud fra den komplekse impedans omfatter bestemmelse af diagnostisk information vedrørende pålideligheden af den analytmålingsinformation, der frembringes af sensoren (10), ud fra den komplekse impedans, hvor sensoren (10) indbefatter et reagenslag (36) dannet på en arbejdselektrode (24), og et resistivt lag eller en resistiv membran (42) er dannet oven på kombinationen af arbejdselektrode (24) og reagenslag (36), og det resistive lag eller den resistive membran (42) er dannet af en biokompatibel polymer, der forhindrer diffusion af enzymer fra arbejdselektroden (24).
2. Fremgangsmåde ifølge krav 1, hvor bestemmelsen af information vedrørende driften af sensoren (10) ud fra den komplekse impedans omfatter bestemmelse af mindst en målt værdi af en analyt, som sensoren (10) udsættes for, i det mindste delvist baseret på den komplekse impedans.
3. Fremgangsmåde ifølge krav 2, der yderligere omfatter: • påtrykning af et jævnstrøms indgangssignal på den i det mindste ene af den ene eller de flere elektroder (24, 28, 32) og • overvågning af et jævnstrømsudgangssignal, der frembringes af sensoren (10) som respons på påtrykningen af j ævnstrømsindgangssignalet, • og hvor bestemmelsen af mindst en målt værdi af analytten omfatter bestemmelse af den mindst ene målte værdi af analytten baseret på den komplekse impedans og på j ævnstrømsudgangssignalet.
4. Fremgangsmåde ifølge krav 3, hvor bestemmelsen af mindst en målt værdi af analytten, som sensoren (10) udsættes for, omfatter: • valg af en matematisk model for sensoren (10) med flere modelkomponenter, • tilpasning af værdierne af den komplekse impedans til den matematiske model for sensoren (10) for at bestemme værdierne af de flere modelkomponenter, • identifikation af en eller en funktionel kombination af de flere modelkomponenter, som har en respons over tid, der, når den kombineres med jævnstrømsudgangssignalet, frembringer en sensorrespons, der har minimale uønskede størrelsesvariationer over tid, og • beregning af den mindst ene målte værdi af analytten baseret på værdier af den identificerede ene eller funktionelle kombination af de flere modelkomponenter og på jævnstrømsudgangssignalet.
5. Fremgangsmåde ifølge krav 4, der yderligere omfatter: • identifikation af en anden eller en funktionel kombination af modelkomponenterne, som har en respons over tid, der er i det væsentlige ufølsom over for variationer i analytkoncentrationen og sensorfølsomheden, • identifikation af kun de af den ene eller en funktionel kombination af de flere modelkomponenter som stabile, for hvilke værdierne af de tilsvarende af den anden eller en funktionel kombination af modelkomponenterne ligger inden for et interval af responsværdier, og • anvendelse af kun de stabile af den ene eller en funktionel kombination af de flere modelkomponenter til at beregne den mindst ene målte værdi af analytten.
6. Fremgangsmåde ifølge krav 2, hvor bestemmelsen af mindst en målt værdi af analytten, som sensoren (10) udsættes for, omfatter: • valg af en matematisk model for sensoren (10) med flere modelkomponenter, • tilpasning af værdierne af den komplekse impedans til den matematiske model for sensoren (10) for at bestemme værdierne af de flere modelkomponenter, • identifikation af en eller en funktionel kombination af de flere modelkomponenter, som har en respons over tid, der frembringer en sensorrespons, der har minimale uønskede størrelsesvariationer over tid, og • beregning af den mindst ene målte værdi af analytten baseret på værdier af den identificerede ene eller funktionelle kombination af de flere modelkomponenter.
7. Fremgangsmåde ifølge krav 4 eller 6, hvor påtrykningen af et tidsvarierende indgangssignal på mindst en af den ene eller de flere elektroder (24, 28, 32) omfatter påtrykning af det tidsvarierende indgangssignal med flere forskellige frekvenser.
8. Fremgangsmåde ifølge krav 6, der yderligere omfatter: • identifikation af en anden eller en funktionel kombination af modelkomponenterne, som har en respons over tid, der er i det væsentlige ufølsom over for variationer i analytkoncentrationen og sensorfølsomheden, • identifikation af kun de af den ene eller en funktionel kombination af de flere modelkomponenter som stabile, for hvilke værdierne af de tilsvarende af den anden eller en funktionel kombination af modelkomponenterne ligger inden for et interval af responsværdier, og • anvendelse af kun de stabile af den ene eller en funktionel kombination af de flere modelkomponenter til at beregne den mindst ene målte værdi af analytten.
9. Fremgangsmåde ifølge krav 1, hvor bestemmelsen af information vedrørende driften af sensoren (10) ud fra den komplekse impedans omfatter bestemmelse af, hvorvidt en udgangsrespons fra sensoren (10) er stabil.
10. Fremgangsmåde ifølge krav 9, hvor bestemmelsen af, hvorvidt en udgangsrespons fra sensoren (10) er stabil, omfatter: • valg af en matematisk model for sensoren (10) med flere modelkomponenter, • tilpasning af værdierne af den komplekse impedans til den matematiske model for sensoren (10) for at bestemme værdierne af de flere modelkomponenter, • identifikation af en eller en funktionel kombination af modelkomponenteme, som har en respons over tid, der er i det væsentlige ufølsom over for variationer i analytkoncentrationen og sensorfølsomheden, og • identifikation alene af sensor (lO)-udgangsresponsprøver, for hvilke værdierne af de tilsvarende af den anden eller en funktionel kombination af modelkomponenterne ligger inden for et interval af responsværdier.
11. Fremgangsmåde ifølge krav 9, der yderligere omfatter frembringelse af et signal, når udgangsresponsen fra sensoren (10) ikke er stabil.
12. Fremgangsmåde ifølge krav 11, hvor frembringelsen af et signal, når udgangsresponsen fra sensoren (10) ikke er stabil, omfatter: • valg af en matematisk model for sensoren (10) med flere modelkomponenter, • tilpasning af værdierne af den komplekse impedans til den matematiske model for sensoren (10) for at bestemme værdierne af de flere modelkomponenter, • identifikation af en eller en funktionel kombination af modelkomponenteme, som har en respons over tid, der er i det væsentlige ufølsom over for variationer i analytkoncentrationen og sensorfølsomheden, og • frembringelse af signalet, hvis flere værdier af den ene eller en funktionel kombination af modelkomponenteren ligger uden for et interval af konstante responsværdier.
13. Fremgangsmåde ifølge krav 9, der yderligere omfatter udførelse af en sensorkalibreringsprocedure, hvis udgangsresponsen fra sensoren (10) ikke er stabil.
14. Fremgangsmåde ifølge krav 13, hvor udførelsen af en sensorkalibreringsprocedure, hvis udgangsresponsen fra sensoren (10) ikke er stabil, omfatter: • valg af en matematisk model for sensoren (10) med flere modelkomponenter, • tilpasning af værdierne af den komplekse impedans til den matematiske model for sensoren (10) for at bestemme værdierne af de flere modelkomponenter, • identifikation af en eller en funktionel kombination af modelkomponenteme, som har en respons over tid, der er i det væsentlige ufølsom over for variationer i analytkoncentrationen og sensorfølsomheden, og • udførelse af sensorkalibreringsproceduren, hvis flere værdier af den ene eller en funktionel kombination af modelkomponenteme ligger uden for et interval af konstante responsværdier.
15. Fremgangsmåde ifølge krav 1, hvor bestemmelsen af information vedrørende driften af sensoren (10) ud fra den komplekse impedans omfatter bestemmelse af mindst et karakteristikum ved sensoren (10) ud fra den komplekse impedans.
16. Fremgangsmåde ifølge krav 9, hvor bestemmelsen af information vedrørende driften af sensoren (10) ud fra den komplekse impedans omfatter bestemmelse af mindst en parameter vedrørende driften af sensoren (10) i et miljø, der indeholder en analyt, ud fra den komplekse impedans.
17. Fremgangsmåde ifølge krav 16, hvor den i det mindste ene parameter vedrørende driften af sensoren (10) i et miljø, der indeholder analytten, indbefatter en elektrisk ledningsevne af miljøet, der indeholder analytten.
18. Fremgangsmåde ifølge krav 1, hvor bestemmelsen af diagnostisk information vedrørende pålideligheden af analytmålingsinformation, der frembringes af sensoren (10), ud fra den komplekse impedans omfatter: • sammenligning af den komplekse impedans med en impedanstærskel og • bestemmelse af, at en elektrisk ledende bane, der er knyttet til sensoren (10), er fejlslagen, hvis den komplekse impedans er større end impedanstærsklen.
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| WO2008104397A3 (en) | 2008-11-06 |
| CA2826887A1 (en) | 2008-09-04 |
| WO2008104397A2 (en) | 2008-09-04 |
| ES2918983T3 (es) | 2022-07-21 |
| ES2694385T3 (es) | 2018-12-20 |
| MX2009008834A (es) | 2009-08-31 |
| PT3454054T (pt) | 2022-06-09 |
| CA2679188C (en) | 2013-11-26 |
| HK1138064A1 (en) | 2010-08-13 |
| EP3454054B1 (en) | 2022-04-20 |
| CY1125246T1 (el) | 2025-03-28 |
| CA2679188A1 (en) | 2008-09-04 |
| KR20090115196A (ko) | 2009-11-04 |
| CN101622528A (zh) | 2010-01-06 |
| EP3454054A1 (en) | 2019-03-13 |
| JP2010520462A (ja) | 2010-06-10 |
| KR101115272B1 (ko) | 2012-03-05 |
| CA2826887C (en) | 2018-03-06 |
| EP2126555B1 (en) | 2018-09-05 |
| DK3454054T3 (da) | 2022-06-20 |
| US7751864B2 (en) | 2010-07-06 |
| HUE058823T2 (hu) | 2022-09-28 |
| JP5567092B2 (ja) | 2014-08-06 |
| SI2126555T1 (sl) | 2018-12-31 |
| PL3454054T3 (pl) | 2022-07-25 |
| CN101622528B (zh) | 2014-11-05 |
| JP2013057669A (ja) | 2013-03-28 |
| PL2126555T3 (pl) | 2018-12-31 |
| EP2126555A2 (en) | 2009-12-02 |
| US20080214910A1 (en) | 2008-09-04 |
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