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Kafe 바로가기국가/구분 | United States(US) Patent 등록 |
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국제특허분류(IPC7판) |
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출원번호 | US-0182862 (2008-07-30) |
등록번호 | US-8142642 (2012-03-27) |
발명자 / 주소 |
|
출원인 / 주소 |
|
대리인 / 주소 |
|
인용정보 | 피인용 횟수 : 2 인용 특허 : 448 |
A sensor designed to determine the amount and concentration of analyte in a sample having a volume of less than about 1 μL. The sensor has a working electrode coated with a non-leachable redox mediator. The redox mediator acts as an electron transfer agent between the analyte and the electrode. In a
A sensor designed to determine the amount and concentration of analyte in a sample having a volume of less than about 1 μL. The sensor has a working electrode coated with a non-leachable redox mediator. The redox mediator acts as an electron transfer agent between the analyte and the electrode. In addition, a second electron transfer agent, such as art enzyme, can be added to facilitate the electrooxidation or etectroreduction of the analyte. The redox mediator is typically a redox compound bound to a polymer. The preferred redox mediators are air-oxidizable. The amount of analyte can be determined by coulometry. One particular coulometric technique includes the measurement of the current between the working electrode and a counter or reference electrode at two or more times. The charge passed by this current to or from the analyte is correlated with the amount of analyte in the sample. Other electrochemical detection methods, such as arnperometric, voltammetric and potentiometric techniques, can also be used. The invention can be used to determine the concentration of a biomolecute, such as glucose or lactate, in a biological fluid, such as blood or serum. An enzyme capable of catalyzing the electrooxidation or electroreduction of the biomolecute is provided as a second electron transfer agent.
1. A method for determining a concentration of an analyte in a body fluid of a patient, comprising the steps of: piercing a portion of the skin of a patient to create a flow of a body fluid;transporting 500 nl or less of the body fluid into an analyte sensor comprising two pairs of electrodes and a
1. A method for determining a concentration of an analyte in a body fluid of a patient, comprising the steps of: piercing a portion of the skin of a patient to create a flow of a body fluid;transporting 500 nl or less of the body fluid into an analyte sensor comprising two pairs of electrodes and a redox mediator, each pair of electrodes comprising a working electrode and a reference or counter electrode, wherein the sensor is configured and arranged for determining the concentration of the analyte from 500 nL or less of body fluid;holding the sample within the analyte sensor in a non-flow through manner such that the sample is in electrolytic contact with the pairs of electrodes; anddetermining by coulomtery the concentration of the analyte in the body fluid from the 500 nl or less of body fluid transported into the analyte sensor. 2. The method of claim 1, wherein the analyte sensor is configured and arranged for determining the concentration of the analyte from 200 nL or less of body fluid. 3. The method of claim 1, wherein the analyte sensor comprises a sample chamber that is configured and arranged to hold 200 nL or less of body fluid. 4. The method of claim 1, wherein the analyte sensor comprises a sample chamber that is configured and arranged to hold 100 nL or less of body fluid. 5. The method of claim 1, wherein the analyte sensor is configured and arranged for determining a concentration of the analyte from 100 nL or less of the body fluid. 6. The method of claim 1, wherein piercing a portion of the skin of a patient to create a flow of a body fluid comprises creating a flow of no more than 500 nL of a body fluid from the patient. 7. The method of claim 1, wherein piercing a portion of the skin of a patient to create a flow of a body fluid comprises creating a flow of no more than 200 nL of a body fluid from the patient. 8. The method of claim 1, wherein each pair of electrodes is a facing electrode pair. 9. The method of claim 1, wherein the sensor further includes a non-leachable enzyme on the working electrodes. 10. The method of claim 9, wherein the enzyme is immobilized on the working electrodes. 11. The method of claim 1, wherein the redox mediator is non-leachably disposed on the working electrodes. 12. The method of claim 11, wherein the redox mediator is immobilized on the working electrodes. 13. The method of claim 1, wherein the body fluid comprises blood. 14. The method of claim 1, wherein the body fluid consists essentially of blood. 15. The method of claim 1, wherein the analyte is glucose. 16. The method of claim 1, wherein transporting a portion of the body fluid into an analyte sensor comprises wicking a portion of the body fluid into the analyte sensor which comprises a sample chamber and a sorbent material disposed in the sample chamber for wicking the portion of the body fluid. 17. The method of claim 1, wherein transporting a portion of the body fluid into an analyte sensor comprises transporting, by capillary action, a portion of the body fluid into a sample chamber of the analyte sensor. 18. The method of claim 1, wherein transporting a portion of the body fluid into an analyte sensor comprises transporting, by application of a vacuum, a portion of the body fluid into a sample chamber of the analyte sensor. 19. The method of claim 1, wherein the analyte sensor comprises a sample chamber that is configured and arranged to hold 500 nL or less of body fluid. 20. The method of claim 1, wherein transporting a portion of the body fluid comprises transporting no more than 200 nL of the body fluid into the analyte sensor. 21. The method of claim 1, wherein the analyte sensor comprises three pairs of electrodes. 22. The method of claim 21, wherein each of said pairs of electrodes is a facing electrode pair. 23. The method of claim 21, wherein the sensor further includes a non-leachable enzyme on the working electrodes. 24. The method of claim 23, wherein the enzyme is immobilized on the working electrodes. 25. The method of claim 21, wherein the redox mediator is non-leachably disposed on the working electrodes. 26. The method of claim 25, wherein the redox mediator is immobilized on the working electrodes. 27. A method for determining a concentration of an analyte in a body fluid of a patient, comprising the steps of: piercing a portion of the skin of a patient to create a flow of a body fluid;transporting 500 nl or less of the body fluid into an analyte sensor comprising three pairs of electrodes and a redox mediator, each pair of electrodes comprising a working electrode and a reference or counter electrode, wherein the sensor is configured and arranged for determining the concentration of the analyte from 500 nL or less of body fluid;holding the sample within the analyte sensor in a non-flow through manner such that the sample is in electrolytic contact with the pairs of electrodes; anddetermining by coulometry the concentration of the analyte in the 500 nl or less of body fluid transported into the analyte sensor. 28. The method of claim 27, wherein the analyte sensor is configured and arranged for determining the concentration of the analyte from 200 nL or less of body fluid. 29. The method of claim 27, wherein the analyte sensor is configured and arranged for determining a concentration of the analyte from 100 nL or less of the body fluid. 30. The method of claim 27, wherein the analyte sensor comprises a sample chamber that is configured and arranged to hold 500 nL or less of body fluid. 31. The method of claim 27, wherein the analyte sensor comprises a sample chamber that is configured and arranged to hold 200 nL or less of body fluid. 32. The method of claim 27, wherein the analyte sensor comprises a sample chamber that is configured and arranged to hold 100 nL or less of body fluid. 33. The method of claim 27, wherein piercing a portion of the skin of a patient to create a flow of a body fluid comprises creating a flow of no more than 500 nL of a body fluid from the patient. 34. The method of claim 27, wherein piercing a portion of the skin of a patient to create a flow of a body fluid comprises creating a flow of no more than 200 nL of a body fluid from the patient. 35. The method of claim 27, wherein transporting a portion of the body fluid comprises transporting no more than 200 nL of the body fluid into the analyte sensor. 36. The method of claim 27, wherein transporting a portion of the body fluid into an analyte sensor comprises wicking a portion of the body fluid into the analyte sensor which comprises a sample chamber and a sorbent material disposed in the sample chamber for wicking the portion of the body fluid. 37. The method of claim 27, wherein transporting a portion of the body fluid into an analyte sensor comprises transporting, by capillary action, a portion of the body fluid into a sample chamber of the analyte sensor. 38. The method of claim 27, wherein transporting a portion of the body fluid into an analyte sensor comprises transporting, by application of a vacuum, a portion of the body fluid into a sample chamber of the analyte sensor. 39. The method of claim 27, wherein each pair of electrodes is a facing electrode pair. 40. A method for determining a concentration of an analyte in a body fluid of a patient, comprising the steps of: piercing a portion of the skin of a patient to create a flow of a body fluid;transporting 500 nl or less of the body fluid into an analyte sensor comprising one pair of electrodes and a redox mediator, the pair of electrodes comprising a working electrode and a reference or counter electrode, wherein the sensor is configured and arranged for determining the concentration of the analyte from 500 nL or less of body fluid;holding the sample within the analyte sensor in a non-flow through manner such that the sample is in electrolytic contact with the pair of electrodes; anddetermining by coulometry the concentration of the analyte in the 500 nl or less of body fluid transported into the analyte sensor. 41. The method of claim 40, wherein the analyte sensor is configured and arranged for determining the concentration of the analyte from 200 nL or less of body fluid. 42. The method of claim 40, wherein the analyte sensor is configured and arranged for determining a concentration of the analyte from 100 nL or less of the body fluid. 43. The method of claim 40, wherein the analyte sensor comprises a sample chamber that is configured and arranged to hold 500 nL or less of body fluid. 44. The method of claim 40, wherein the analyte sensor comprises a sample chamber that is configured and arranged to hold 200 nL or less of body fluid. 45. The method of claim 40, wherein the analyte sensor comprises a sample chamber that is configured and arranged to hold 100 nL or less of body fluid. 46. The method of claim 40, wherein piercing a portion of the skin of a patient to create a flow of a body fluid comprises creating a flow of no more than 500 nL of a body fluid from the patient. 47. The method of claim 40, wherein piercing a portion of the skin of a patient to create a flow of a body fluid comprises creating a flow of no more than 200 nL of a body fluid from the patient. 48. The method of claim 40, wherein transporting a portion of the body fluid comprises transporting no more than 200 nL of the body fluid into the analyte sensor. 49. The method of claim 40, wherein transporting a portion of the body fluid into an analyte sensor comprises wicking a portion of the body fluid into the analyte sensor which comprises a sample chamber and a sorbent material disposed in the sample chamber for wicking the portion of the body fluid. 50. The method of claim 40, wherein transporting a portion of the body fluid into an analyte sensor comprises transporting, by capillary action, a portion of the body fluid into a sample chamber of the analyte sensor. 51. The method of claim 40, wherein transporting a portion of the body fluid into an analyte sensor comprises transporting, by application of a vacuum, a portion of the body fluid into a sample chamber of the analyte sensor. 52. The method of claim 40, wherein the pair of electrodes is a facing electrode pair. 53. The method of claim 40, wherein the analyte sensor comprises glucose oxidase or glucose dehydrogenase. 54. The method of claim 40, wherein the redox mediator comprises an osmium complex, a ferrocyanide, or a ferricyanide. 55. The method of claim 40, wherein the working electrode is constructed of a material selected from gold, carbon, platinum, ruthenium dioxide and palladium. 56. The method of claim 40, wherein the working electrode is separated from the reference or counter electrode by a distance of less than 200 micrometer. 57. The method of claim 40, wherein the piercing comprise piercing the skin on a forearm of the patient.
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