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Kafe 바로가기국가/구분 | United States(US) Patent 등록 |
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국제특허분류(IPC7판) |
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출원번호 | US-0569019 (2009-09-29) |
등록번호 | US-8268163 (2012-09-18) |
발명자 / 주소 |
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출원인 / 주소 |
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대리인 / 주소 |
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인용정보 | 피인용 횟수 : 0 인용 특허 : 455 |
A sensor utilizing a non-leachable or diffusible redox mediator is described. The sensor includes a sample chamber to hold a sample in electrolytic contact with a working electrode, and in at least some instances, the sensor also contains a non-leachable or a diffusible second electron transfer agen
A sensor utilizing a non-leachable or diffusible redox mediator is described. The sensor includes a sample chamber to hold a sample in electrolytic contact 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 blood or serum, using techniques such as coulometry, amperometry; and potentiometry. An enzyme capable of catalyzing the electrooxidation or electroreduction of the biomolecule is typically provided as a second electron transfer agent.
1. A sensor for determining the concentration of glucose in a sample fluid, the sensor comprising: a first electrode disposed on a first substrate and a second electrode disposed on a second substrate, wherein the first electrode comprises palladium and the second electrode comprises gold, and where
1. A sensor for determining the concentration of glucose in a sample fluid, the sensor comprising: a first electrode disposed on a first substrate and a second electrode disposed on a second substrate, wherein the first electrode comprises palladium and the second electrode comprises gold, and wherein the first electrode and the second electrode are in a facing configuration and separated by an effective distance in a range of 25 to 1000 μm;a spacer comprising a first part and a second part disposed between the first and second substrates, wherein the first part of the spacer, the second part of the spacer, the first substrate, and the second substrate define a first aperture along a first side edge of the sensor and a second aperture along a second side edge of the sensor, wherein either the first aperture or the second aperture is used for sample application and the sensor has no more than two apertures;a sample chamber for holding the sample fluid and sized to contain a volume of no more than about 1 μL of the sample fluid, wherein the sample chamber has a length which extends from the first aperture to the second aperture and a substantially uniform width between the first part of the spacer and the second part of the spacer along the entire length of the sample chamber, and wherein the width of the sample chamber is not wider than either the first aperture or the second aperture; anda glucose dehydrogenase and a redox mediator comprising ferricyanide disposed in the sample chamber;wherein the first and second substrates define a sensor comprising a proximal end having a width and a distal end having a width, the distal end being configured for insertion into a sensor reader, wherein the width of the distal end is greater than the width of the proximal end. 2. The sensor of claim 1, wherein the sensor comprises an indicator electrode disposed in the sensor to indicate when the sample chamber contains a sample. 3. The sensor of claim 2, wherein the indicator electrode is also the first electrode or the second electrode. 4. The sensor of claim 2, further comprising a visual or auditory sign, coupled to the indicator electrode, that activates when the indicator electrode indicates that the sample chamber contains sample. 5. The sensor of claim 2, wherein the indicator electrode is disposed in facing relationship to one of the first electrode and the second electrode. 6. The sensor of claim 1, wherein the sensor comprises at least two indicator electrodes disposed in the sensor, wherein a first indicator electrode indicates when the sample chamber is beginning to fill with sample, and a second indicator electrode indicates when the sample chamber is substantially filled with sample. 7. The sensor of claim 6, wherein the sensor comprises two indicator electrodes disposed in the sensor, and wherein either the first electrode or the second electrode is disposed between the two indicator electrodes. 8. The sensor of claim 1, wherein at least a portion of the first electrode is within an effective distance of no more than 200 μm of a portion of the second electrode. 9. The sensor of claim 1, wherein either the first electrode or the second electrode is a counter/reference electrode, and wherein the sensor is configured and arranged so that the mediator oxidizes the glucose and the half-wave potential of the redox mediator, as measured by cyclic voltammetry in 0.1 M NaCl at pH 7, is no more than about +100 millivolts relative to the potential of the counter/reference electrode. 10. The sensor of claim 1, wherein either the first electrode or the second electrode is a counter/reference electrode, and wherein the sensor is configured and arranged so that the mediator oxidizes the glucose and the half-wave potential of the redox mediator, as measured by cyclic voltammetry in 0.1 M NaCl at pH 7, is about the same as the potential of the counter/reference electrode. 11. The sensor of claim 1, wherein either the first electrode or the second electrode is a counter/reference electrode, and wherein the sensor is configured and arranged so that the mediator oxidizes the glucose and the half-wave potential of the redox mediator, as measured by cyclic voltammetry in 0.1 M NaCl at pH 7, is no more than about −150 millivolts relative to the potential of the counter/reference electrode. 12. The sensor of claim 1, wherein the redox mediator is diffusible, and wherein, within the sensor, the effective diffusion coefficient of the redox mediator through the sample fluid is less than the effective diffusion coefficient of the glucose through the sample fluid. 13. The sensor of claim 1, wherein the redox mediator is a diffusible mediator having a molecular weight of at least 5,000 daltons. 14. The sensor of claim 1, wherein the first electrode is a working electrode and the second electrode is a counter/reference electrode, and wherein the sensor is configured and arranged so that the redox mediator is more readily electrolyzed on the working electrode than the counter/reference electrode. 15. The sensor of claim 1, wherein the sensor comprises a molar amount of the redox mediator that is, on a stoichiometric basis, no more than 80 mg/dL of glucose. 16. The sensor of claim 1, wherein the first electrode is a working electrode, and wherein the working electrode has a surface area of no more than about 0.01 cm2 exposed in the sample chamber. 17. The sensor of claim 1, wherein the activity of the glucose dehydrogenase is no more than 1 unit/cm3. 18. The sensor of claim 1, wherein the first electrode is a working electrode and the second electrode is a counter/reference electrode, wherein the redox mediator is a diffusible redox mediator, and wherein the sensor is configured and arranged so that the diffusible redox mediator precipitates when reacted at the counter/reference electrode. 19. The sensor of claim 1, wherein the redox mediator is diffusible, and wherein the sensor is configured and arranged so that a mathematical product of the effective diffusion coefficient of the redox mediator and the concentration of the redox mediator is no more than 1×10−12 moles cm−1 sec−1 when sample fluid fills the sample chamber. 20. The sensor of claim 1, wherein the first electrode is a working electrode, and wherein the redox mediator is disposed on the working electrode. 21. The sensor of claim 1, wherein the first electrode is a working electrode, and wherein the glucose dehydrogenase is disposed on the working electrode. 22. The sensor of claim 1, wherein the first substrate comprises a cutout portion at the distal end to expose a portion of the second electrode disposed on the second substrate. 23. The sensor of claim 1, wherein the second substrate comprises a cutout portion at the distal end to expose a portion of the first electrode disposed on the first substrate. 24. A method for determining a concentration of glucose in a sample, comprising the steps of: contacting a sample with a sensor, wherein the sensor comprises: a first electrode disposed on a first substrate and a second electrode disposed on a second substrate, wherein the first electrode comprises palladium and the second electrode comprises gold, and wherein the first electrode and the second electrode are in a facing configuration and separated by an effective distance in a range of 25 to 1000 μm;a spacer comprising a first part and a second part disposed between the first and second substrates, wherein the first part of the spacer, the second part of the spacer, the first substrate, and the second substrate define a first aperture along a first side edge of the sensor and a second aperture along a second side edge of the sensor, wherein either the first aperture or the second aperture is used for sample application and the sensor has no more than two apertures;a sample chamber for holding the sample fluid and sized to contain a volume of no more than about 1 μL of the sample fluid, wherein the sample chamber has a length which extends from the first aperture to the second aperture and a substantially uniform width between the first part of the spacer and the second part of the spacer along the entire length of the sample chamber, and wherein the width of the sample chamber is not wider than either the first aperture or the second aperture; anda glucose dehydrogenase and a redox mediator comprising ferricyanide disposed in the sample chamber;wherein the first and second substrates define a sensor comprising a proximal end having a width and a distal end having a width, the distal end being configured for insertion into a sensor reader, wherein the width of the distal end is greater than the width of the proximal end;generating a sensor signal at the first electrode, anddetermining the concentration of the glucose using the sensor signal. 25. The method according to claim 24, wherein determining the concentration of the glucose comprises determining the concentration of the glucose by coulometry using the sensor signal. 26. The method according to claim 24, wherein determining the concentration of the glucose comprises determining the concentration of the glucose by amperometry using the sensor signal. 27. The method according to claim 24, wherein determining the concentration of the glucose comprises determining the concentration of the glucose by potentiometry using the sensor signal. 28. The method according to claim 24, wherein determining the concentration of the glucose comprises determining the concentration of the glucose by chronoamperometry using the sensor signal. 29. The method according to claim 24, wherein determining the concentration of the glucose comprises determining the concentration of the glucose by chronopotentiometry using the sensor signal. 30. The method according to claim 24, further comprising: providing calibration data on a batch of the electrochemical sensors to a measurement instrument, said calibration data comprising information related to a magnitude of a background charge for the batch of the electrochemical sensors;wherein the step of determining the concentration of the glucose comprises determining the concentration of the glucose using the sensor signal and the calibration data. 31. The method according to claim 24, comprising obtaining the sample from a subject. 32. The method according to claim 31, wherein the sample is blood obtained from a finger of the subject. 33. The method according to claim 31, wherein the sample is blood obtained from a region of the subject having a lower nerve end density as compared to a fingertip. 34. The method according to claim 33, wherein the region of the subject having a lower nerve end density as compared to a fingertip is selected from the group consisting of: a forearm region, and a thigh region. 35. The method according to claim 24, wherein the first substrate comprises a cutout portion at the distal end to expose a portion of the second electrode disposed on the second substrate. 36. The method according to claim 24, wherein the second substrate comprises a cutout portion at the distal end to expose a portion of the first electrode disposed on the first substrate. 37. A method for determining a concentration of glucose in a sample, the method comprising the steps of: contacting a sample with a sensor, wherein the sensor comprises: a first electrode disposed on a first substrate and a second electrode disposed on a second substrate, wherein the first electrode comprises palladium and the second electrode comprises gold, and wherein the first electrode and the second electrode are in a facing configuration and separated by an effective distance in a range of 25 to 1000 μm;a spacer comprising a first part and a second part disposed between the first and second substrates, wherein the first part of the spacer, the second part of the spacer, the first substrate, and the second substrate define a first aperture along a first side edge of the sensor and a second aperture along a second side edge of the sensor, wherein either the first aperture or the second aperture is used for sample application and the sensor has no more than two apertures;a sample chamber for holding the sample fluid and sized to contain a volume of no more than about 1 μL of the sample fluid, wherein the sample chamber has a length which extends from the first aperture to the second aperture and a substantially uniform width between the first part of the spacer and the second part of the spacer along the entire length of the sample chamber, and wherein the width of the sample chamber is not wider than either the first aperture or the second aperture; anda glucose dehydrogenase and a redox mediator comprising ferricyanide disposed in the sample chamber;wherein the first and second substrates define a sensor comprising a proximal end having a width and a distal end having a width, the distal end being configured for insertion into a sensor reader, wherein the width of the distal end is greater than the width of the proximal end;observing a signal from an indicator electrode to signify that the sample chamber contains sample;applying a potential between the first electrode and the second electrode to electrolyze the glucose in the sample;generating a glucose-responsive signal from the sensor in response to electrolysis of the glucose in the sample; anddetermining the concentration of the glucose using the glucose-responsive signal. 38. The method according to claim 37, comprising obtaining the sample from a subject. 39. The method according to claim 38, wherein the sample is blood obtained from a finger of the subject. 40. The method according to claim 38, wherein the sample is blood obtained from a region of the subject having a lower nerve end density as compared to a fingertip. 41. The method according to claim 40, wherein the region of the subject having a lower nerve end density as compared to a fingertip is selected from the group consisting of: a forearm region, and a thigh region.
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