CN1598564A - 测量仪 - Google Patents
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Abstract
一种用于确定生物体液(例如血液)在医学上的主要成分(例如葡萄糖)的浓度的装置(31,32,132)和方法,包括提供用于接收所述体液(例如血液)试样的容器(31)。所述容器(31)维持一种和所述的在医学上的主要成分(例如葡萄糖)进行化学反应的化学物质,并具有第一和第二端子,跨越所述端子可以确定所述化学物质和在医学上的主要成分进行的化学反应。一种器具(32,132)具有分别和所述容器的所述第一和第二端子互补的第一(34-2,134-2)和第二(34-3,134-3)端子。提供确定控制器(52,54,148,158)。所述装置用于确定试样的类型和在试样中的在医学上的主要成分的浓度。
Description
技术领域
本发明涉及一种用于改进例如美国专利5243516、5288636、5352351、5385866、和5508171所述的那类测量仪进行的测量的精度的方法和装置。本发明的内容在一种仪器中被披露了,但是相信本发明也可应用于这种统称类型的其它仪器中。
背景技术
有许多用于在生物学上确定体液的主要成分的浓度例如血糖浓度的仪器。例如在下述的专利文献中所述的仪器,美国专利:3770607、3838033、3902970、3925183、3937615、4005002、4004908、4086631、4123701、4127448、4124968、4127196、4224125、4225410、4230537、4260680、4263343、4265250、4273134、4301412、4303887、4366033、4407959、4413628、4420564、4431004、4436094、4440175、4477314、4477575、4499423、4517291、4654197、4671288、4679652、4682602、4703756、4711245、4734184、4750496、4759828、4789804、4795542、4805624、4820399、4897162、4897173、4919770、4927516、4935106、4938860、4940945、4970145、4975647、4999582、4999632、5108564、5128015、5243516、5269981、5288636、5312762、5352351、5385864、5395504、5469846、5508171、5508203、和5509410;德国专利说明书3228542;欧洲专利说明书206218、230472、241309、255291、和471896;以及日本公开专利申请JP 63-128252和63-111453。在下述的文献中也描述了所述方法和装置:Talbott等人的“A New MicrochemicalApproach to Amperometric Analysis”Microchemical Jourmal,Vol.37,pp.5-12(1988);Nirris等人的“An Electrochemical Capillary FillDevice for the Analysis of Dlucose Incorporating Glucose Oxidaseand Ruthenium(III)Hexamine as Mediator,Electroanalysis”Vol4,pp.1-9(1992);Cass等人的“Ferrocene-Mediated Enzyme Electrodefor Amperometric Determination of Glucose”Anal.Chem.,Vol.56,pp.667-671(1984);Zhao的“Contributions of Suspending Medium toElectrical Impedance of Blood”Biochimica et Biophysica Acta,Vol.1201,pp.179-185(1994);Zhao的,“Electrical Impedance and Haematocrit of Human Blood with VariousAnticoagulants,”Physiol.Meas.,Vol.14,pp.299-307(1993);Muller,等人的,“Influence of Hematocrit and Platelet Count on Impedance and Reactivity of WholeBlood for Electrical Aggregometry,”Journal of Pharmacological and ToxicologicalMethods,Vol.34,pp.17-22(1995);Preidel,等人的,“In Vitro Measurements withElectrocatalytic Glucose Sensor in Blood,”Biomed.Biochim.Acta,Vol.48,pp.897-903(1989);Preidel,等人的,“Glucose Measurements by Electrocatalytic Sensor in theExtracorporeal Blood Circulation of a Sheep,”Sensors and Actuators B,Vol.2,pp.257-263(1990);Saeger,等人的,“Influence of Urea on the Glucose Measurement byElectrocatalytic Sensor in the Extracorporeal Blood Circulation of a Sheep,”Biomed.Biochim.Acta,Vol.50,pp.885-891(1991);Kasapbasioglu,等人的,“An ImpedanceBased Ultra-Thin Platinum Island Film Glucose Sensor,”Sensors and Actuators B,Vol.13-14,pp.749-751(1993);Beyer,等人的,“Development and Application of a NewEnzyme Sensor Type Based on the EIS-Capacitance Structure for BioprocessControl,”Biosensors & Bioelectronics,Vol.9,pp.17-21(1994);Mohri,等人的,“Characteristic Response of Electrochemical Nonlinearity to Taste Compounds with aGold Electrode Modified with 4-Aminobenzenethiol,”Bull.Chem.Soc.Jpn.,Vol.66,pp.1328-1332(1993);Cardosi,等人的,“The Realization of Electron Transfer fromBiological Molecules to Electrodes,”
Biosensors Fundamentals and Applications,chapt.15(Turner,et al,eds.,Oxford University Press,1987);Mell,等人的,“AmperometricResponse Enhancement of the Immobilized Glucose Oxidase Enzyme Electrode,”Analytical Chemistry,Vol.48,pp.1597-1601(Sept.1976);Mell,等人的,“A Model forthe Amperometric Enzyme Electrode Obtained Through Digital Simulation andApplied to the Immobilized Glucose Oxidase System,”Analytical Chemistry,Vol.47,pp.299-307(Feb.1975);Myland,等人的,“Membrane-Covered Oxygen Sensors:AnExact Treatment of the Switch-on Transient,”Journal of the Electrochemical Society,Vol.131,pp.1815-1823(Aug.1984);Bradley,等人的,“Kinetic Analysis of EnzymeElectrode Response,”Anal.Chem.,Vol.56,pp.664-667(1984);Koichi的,”Measurements of Current-Potential Curves,6,Cottrell Equation and itsAnalogs.What Can We Know from Chronoamperometry?”Denki Kagaku oyobiKogyo Butsuri Kagaku,Vol.54,no.6,pp.471-5(1986);Williams,等人的,“Electrochemical-Enzymatic Analysis of Blood Glucose and Lactate,”AnalyticalChemistry,Vol.42,no.1,pp.118-121(Jan.1970);and,Gebhardt,等人的,“Electrocatalytic Glucose Sensor,”Siemens Forsch.-u.Entwickl.-Bre.Bd.,Vol.12,pp.91-95(1983)。上述的参考文献并不能完全代表现有技术,也不说明除此之外没有更好的参考文献。据推断不应当存在所谓最好的现有技术。
发明内容
按照本发明的一个方面,用于确定生物体液在医学上的主要成分的浓度的一种装置包括用于接收所述体液试样的容器。所述容器维持一种和所述的在医学上的主要成分进行化学反应的化学物质,并支持第一和第二端子,跨越所述端子可以确定所述化学物质和在医学上的主要成分进行的化学反应。所述装置还包括具有分别和所述容器的所述第一和第二端子互补的第一和第二端子的器具。所述容器的第一和第二端子的布置使得分别和所述器具的第一和第二端子接触,从而使得所述器具能够确定所述反应。所述器具包括确定控制器,用于在所述器具的第一和第二端子之间施加第一信号,确定容器对第一信号的第一响应,并根据第一响应确定是否继续进行生物体液的在医学上的主要成分的浓度的确定。
按照本发明的另一个方面,用于确定生物体液在医学上的主要成分的浓度的一种装置包括用于接收所述体液试样的容器。所述容器维持一种和所述的在医学上的主要成分进行化学反应的化学物质(chemistry),并支持第一和第二端子,跨越所述端子可以确定所述化学物质和在医学上的主要成分进行的化学反应。所述装置还包括具有分别和所述容器的所述第一和第二端子互补的第一和第二端子的器具。所述容器的第一和第二端子的布置使得分别和所述器具的第一和第二端子接触,从而使得所述器具能够确定所述反应。所述器具包括确定控制器,用于在所述器具的第一和第二端子之间施加第一信号,根据所述容器对第一信号的响应确定第一校正值,确定在医学上的主要成分的化学反应,并组合校正值和反应确定的结果,从而产生试样中的在医学上的主要成分的浓度的指示。
按照本发明的另一个方面,用于确定生物体液在医学上的主要成分的浓度的一种装置包括用于接收所述体液试样的容器,所述容器维持和所述的在医学上的主要成分进行化学反应的化学物质,并支持第一和第二端子,跨越所述端子可以确定所述化学物质和在医学上的主要成分进行的化学反应。所述装置还包括具有分别和所述容器的所述第一和第二端子互补的第一和第二端子的器具。所述容器的第一和第二端子的布置使得分别和所述器具的第一和第二端子接触,从而使得所述器具能够确定所述反应。所述器具包括确定控制器,用于在所述器具的第一和第二端子之间施加第一信号,根据所述容器对第一信号的响应确定试样的性质,并产生一个试样性质的指示。
按照本发明的一个方面,用于确定生物体液在医学上的主要成分的浓度的一种方法包括提供用于接收所述体液试样的容器,并在所述容器上提供一种和所述的在医学上的主要成分进行化学反应的化学物质,并提供第一和第二端子,跨越所述端子可以确定所述化学物质和在医学上的主要成分进行的化学反应。所述方法还包括提供一种具有分别和所述容器的所述第一和第二端子互补的第一和第二端子的器具。所述容器的第一和第二端子的布置使得分别和所述器具的第一和第二端子接触,从而使得所述器具能够确定所述反应。所述方法还包括在所述器具中提供确定控制器,使所述确定控制器在所述器具的第一和第二端子之间施加第一信号,使所述确定控制器确定容器对第一信号的第一响应,并使所述确定控制器根据第一响应确定是否继续进行生物体液的在医学上的主要成分的浓度的确定。
按照本发明的一个方面,用于确定生物体液在医学上的主要成分的浓度的一种方法包括提供用于接收所述体液试样的容器,并在所述容器上提供一种和所述的在医学上的主要成分进行化学反应的化学物质,并提供第一和第二端子,跨越所述端子可以确定所述化学物质和在医学上的主要成分进行的化学反应。所述方法还包括提供一种具有分别和所述容器的所述第一和第二端子互补的第一和第二端子的器具。所述容器的第一和第二端子的布置使得分别和所述器具的第一和第二端子接触,从而使得所述器具能够确定所述反应。所述方法还包括在所述器具中提供确定控制器,用于在所述器具的第一和第二端子之间施加第一信号,根据第一信号确定第一校正值,确定医学上的主要成份和化学物质的反应情况,并将校正值和反应确定结果结合起来以产生在试样中医学上主要成分的浓度指示,并产生一个试样性质的指示。
按照本发明的一个方面,用于确定生物体液在医学上的主要成分的浓度的一种方法包括提供用于接收所述体液试样的容器,并在所述容器上提供一种和所述的在医学上的主要成分进行化学反应的化学物质,并提供第一和第二端子,跨越所述端子可以确定所述化学物质和在医学上的主要成分进行的化学反应。所述方法还包括提供一种具有分别和所述容器的所述第一和第二端子互补的第一和第二端子的器具。所述容器的第一和第二端子的布置使得分别和所述器具的第一和第二端子接触,从而使得所述器具能够确定所述反应。所述方法还包括在所述器具中提供确定控制器,用于在所述器具的第一和第二端子之间施加第一信号,根据所述容器对第一信号的响应确定试样的性质,并产生一个试样性质的指示。
例如,第一信号包括具有交流分量的信号。另外例如,第一信号包括交流信号。
附带说明,用于确定校正值的方法和装置、用于确定试样性质的方法和装置、用于确定是否继续进行在医学上生物体液的主要成分的浓度的方法和装置包括用于确定所述容器端子之间的阻抗的步骤和用于确定所述容器端子之间的阻抗的装置。
附图说明
参照下面的详细说明和用于说明本发明的附图可以更好地理解本发明。其中:
图1是用于理解本发明的电路的示意图;
图2是按照本发明构成的仪器的部分方块图和部分示意图;
图3是按照本发明构成的另一种仪器的部分方块图和部分示意图;
图4是按照本发明构成的另一种仪器的部分方块图和部分示意图;
图5是利用标准的葡萄糖测试液在几个40秒葡萄糖浓度确定中获得的葡萄糖浓度的结果;
图6是利用标准的葡萄糖测试液在几个10秒葡萄糖浓度确定中获得的葡萄糖浓度的结果;以及
图7是利用标准的葡萄糖测试液在几个10秒葡萄糖浓度确定中获得的葡萄糖浓度的结果。
具体实施例详细描述
使用例如一次性的中间的测量电流的容器(下面有时称为生物传感器)的仪器是已知的,当利用具有在生物学上作为主要成分例如葡萄糖的某个相应浓度的生物液体例如血或尿处理时,这种仪器例如提供特征电阻抗。这种测量***对于生物液体的温度变化以及由于其它成分的生物液体的存在,在下面被称为干扰物,而引起的干扰是敏感的。在许多情况下,这些误差源对生物传感器的输出的影响具有和要测量的成分的浓度相同的数量级。可能不会研制出一种生物传感器,其在存在这些误差源的情况下只测量要测量的成分的浓度。这种现象的一个例子是在美国专利5243516、5288636、5352351、5385846、5508171中所述类型的生物传感器用于确定全血的葡萄糖浓度时存在的分血器干扰。因为全血含有红细胞,并因为分血器对于进行这种生物传感器化验的每个人而有相当宽的变化范围,分血器补偿的葡萄糖生物传感器的效用是明显的。
许多市场上可得到的生物传感器对于掺杂质的生物液体的量的敏感度也是问题。在测量全血葡萄糖浓度的情况下,例如,许多目前可利用的生物传感器对于被搀入用于确定葡萄糖浓度的血的量是敏感的。因为目前使用生物传感器进行的许多化验例如由监视着其自己的葡萄糖浓度的人进行,所以搀入生物传感器中的血样的量不能以大的可靠性进行预测,虽然生物传感器本身的仔细的设计可以避免一些误差,例如非搀入的生物传感器、基本上欠搀入的生物传感器和基本上过搀入的生物传感器,但是实际上不能考虑搀入量变化的整个范围。
我们发现,合适设计的生物传感器的交流阻抗的实部分量或虚部分量或者这两个分量的测量对于试样的温度和某个物理与化学干扰物的浓度进行了合理的理解。在美国专利5243516、5288636、5352351、5385846、5508171、5437399以及1997,12,5申请的和本申请为同一个代理人的U.S.S.N.08/985840专利申请中所述的一般类型的生物传感器中,这种物理干扰物例如包括分血器,化学干扰物例如包括胆红素、尿酸和氧气。我们发现,合适设计的生物传感器的交流阻抗的实部分量或虚部分量或者这两个分量的测量还对搀入生物传感器的试样的量以及试样的性质,即试样是否是血或者一些其它的体液,或者是一些控制使用的试样,例如在仪器的校准和检修中使用的试样,提供了合理的理解。我们发现,试样温度、物理和化学干扰物的浓度、试样的性质和试样的量可以通过合理地选择交流频率,对试样温度、物理和化学干扰物的浓度、试样的性质和试样的量的影响的确定提供合理的相互隔离而被确定,借以增加例如确定干扰物影响,以及随后的葡萄糖浓度指示值的校正的精度。我们还发现,获得校正的葡萄糖浓度的可接受的精度的读数的速度可以被显著地减少。合理地设计的生物传感器必须能够允许例如使用具有几十毫伏的峰值的交流信号确定这些交流阻抗,而不损害生物传感器在进行交流阻抗确定的前后或在交流阻抗的测定当中的葡萄糖浓度的测量。
仅仅作为例子,我们已经确定,在美国专利5243516、5288636、5352351、5385846、5508171、5437999以及U.S.S.N 08/985840中所述类型的生物传感器中,能够使用小于大约1-10Hz范围内的例如有效值小于40毫伏的低幅值交流信号而没有直流偏移,以便补偿试样温度、分血器、胆红素浓度、尿酸浓度和氧气浓度,并确定生物传感器搀入的试样的性质,和搀入的用于确定葡萄糖浓度的血样量是否足够。我们已经确定,例如,在大约1300Hz下,分血器和葡萄糖浓度两者对交流阻抗具有相当小的影响,而试样量和试样性质对交流阻抗具有相当大的相当容易确定的影响。这提供了一种用于确定生物传感器搀入的试样量的足够度和试样性质的理想方法。如果试样被确定是血,并且试样量被确定不足以对分血器、葡萄糖浓度等进行有意义地测试,则测试被中断,并把测试的中断通知用户。
我们已经确定,使用范围大约为2-10KHz的频率,试样温度和分血器的组合影响可以被和其它感兴趣的物理的和化学的干扰物的影响相当有效地隔离。因此,例如,一旦确定试样量足够,便可以对生物传感器施加2KHz的信号,并确定生物传感器/试样***的阻抗的实部和虚部分量。这个指示的阻抗可利用通过实验确定的系数根据生物传感器的特性进行调整,并可以和指示的葡萄糖浓度结合,以便获得一个被补偿试样温度以及分血器的组合影响的葡萄糖浓度。
这些说明性的确定在血样的葡萄糖浓度的电流确定之前进行。如果需要,可以避免直流偏移,以便减少影响电流确定的葡萄糖浓度的可能性,必须记住,这在随后在所述的实施例中即将进行。同样在所述的实施例中,在电流确定葡萄糖浓度之前,可以进行类似的处理,从而确定其它的干扰葡萄糖浓度确定的化学干扰物的浓度,例如胆红素、尿酸和氧气。这些确定在这样的频率下进行,在所述频率下,它们的相互影响以及对其它的物理、化学干扰物的影响被最佳地相互解耦。例如,如果在电流测量容器的化学***中,胆红素和尿酸是相互干扰的化学干扰物,频率或频率的范围应当选择用于胆红素浓度确定的范围,该频率或频率范围对于不受试样中的尿酸和其它物理、化学干扰物的浓度的影响而言是最佳的。类似地,对于尿酸浓度确定必须选择这样的频率,该频率对于不受试样中的胆红素和其它物理、化学干扰物的浓度的影响而言是最佳的。不过,在每种情况下,确定的阻抗被直接地或者通过也可以向用户显示或者被存储在仪器中供将来参考的浓度确定转换为一个用于指示的葡萄糖浓度的校正系数,以便获得更精确的葡萄糖浓度确定。
通过分析在在美国专利5243516、5288636、5352351、5385846、5508171、5437999以及U.S.S.N 08/985840中所述类型的电流测量传感器的等效电路可以更好地理解所述方法和装置。所述等效电路如图1所示。在图1中,电阻20代表电流测量容器的未被补偿的电阻,电容22代表在施加有电位差的含有试样的容器上的双层电荷的分布电容,电阻24代表容器的化学传递电阻,电阻26和电容28代表所谓的瓦氏阻抗。虽然其它类型的电流测量传感器的电参数模型可能和图1所示的不同,但是这些模型的类似的分析将得出和此处类似的结论,即,容器或生物传感器的电阻抗的实部和虚部分量提供了一种用于以一个合理的精度确定干扰物浓度、试样量和试样性质对于体液试样中的生物主要成分的浓度的影响的技术。这些结论给仪器和容器设计者提供了一种有用的技术,用于确定施加于生物传感器的试样量的足够度,用于确定试样的性质,并用于根据这些干扰物的浓度校正试样的生物主要成分的指示浓度,使得这些干扰物的浓度对感兴趣的生物主要成分的指示浓度的影响被减小,从而提供关于感兴趣的生物主要成分的浓度的更精确的信息。
通过分析图1的等效电路的阻抗的实部和虚部分量的幅值而进行的血样研究已经确定,在大约1-10KHz的范围内,阻抗的虚部分量和试样的葡萄糖浓度的相关性很小,而阻抗的幅值则在很大程度上取决于试样温度和分血器的组合,从而允许使用在美国专利5243516、5288636、5352351、5385846、5508171、5437999以及U.S.S.N 08/985840中所述电流测量技术,首先对试样施加这个频率范围内的低幅值的交流信号,确定阻抗的幅值,和要和确定的指示葡萄糖浓度结合的组合试样温度/分血器校正系数,从而产生根据试样温度和分血器的组合影响进行校正的葡萄糖浓度。类似的技术可以用于确定试样量和试样类型。不过,试样量确定通常决定是否进行其它的化验。试样类型确定通常决定仪器是否执行葡萄糖浓度子程序,例如包括确定干扰物校正系数,或者执行诊断子程序,用于设置仪器稍后执行葡萄糖浓度确定。
参看图2,在美国专利5243516、5288636、5352351、5385846、5508171中所述一般类型的带状连接器30用于实现这些专利中所述的一般类型的一次性电流测量传感器容器或生物传感器31和仪器32之间的接触。仪器32的指示葡萄糖浓度的功能性基本上和这些专利所述的相同。不过,按照本发明,在仪器32中包括附加的功能,即,根据血样量和试样温度与进行化验的血样的分血器的组合影响,校正指示葡萄糖浓度。已经确定,8位的模数(A/D)和数模(D/A)计算能力可以使仪器32达到在百分之五十或更低的范围内的精度。连接器34的第一端34-1通过10KΩ的电阻和开关36的一端36-1相连。开关36的一端36-2和差动放大器38的反相输入端或负输入端相连。放大器38的输出端和开关36的一端36-3相连。开关36的一端36-4和连接器34的一端34-2相连。加于生物传感器31上的直流激励由放大器38的输出建立。为了精确地设置生物传感器31的直流激励,来自一端34-1的反馈被返回到放大器38的负输入端。端子34-1和34-2接触生物传感器31上的一个公共电极,用于增加激励的精度。
连接器34的端子34-3和差动放大器42的负输入端相连。放大器42的输出端通过7.5KΩ的电阻44和其负输入端相连。放大器42的非反相输入端或正输入端和电源的公共点相连。放大器42的输出端和13位A/D转换器46的输入端相连。A/D转换器46的输出端和处理器48的输入端相连,处理器48具有支持执行在美国专利5243516、5288636、5352351、5385846、5508171中所述的指示葡萄糖测量功能的功能。处理器48的输出和8位D/A转换器50的输入端相连。D/A转换器50的输出端和放大器38的正输入端相连。所示的元件38,42,46和50的功能被包括在一个专用集成电路(ASIC)52中。虽然并不一定如此。其余的所示的仪器32的分血器补偿和试样量确定功能被包括在NEC μPD78054微处理器(μP)54中,后者也具有输入A/D转换器56和输出D/A转换器58。在图2中,为清楚起见,输入A/D转换器56和输出D/A转换器58和μP54的处理功能被分开表示。开关36的端子36-4和A/D转换器56的输入端相连。放大器42的输出端和A/D转换器56的输入端相连。D/A转换器58的输出端通过0.1μF的电容器和400KΩ的串联电阻和开关36的端子36-1相连,在本例中用于交流激励。其中交流激励信号和由放大器38提供的直流激励相加。
和端子34-1、-2、与-3相连的生物传感器容器31的交流阻抗的实部和虚部分量的计算通过在所需的频率下例如1300Hz或10kHz激励连接器34-2的端子进行,在此频率下,要被确定的参数,不论试样性质或试样量或分血器或其它感兴趣的参数都可以被这样确定,使得具有足够的幅值和相位的变化,并且被最佳地解耦,即不干扰在容器31中的血的其它成分的浓度。
由交流激励和响应进行的容器31的阻抗的实部和虚部分量的计算方法如下。8位的激励采样是N个值E(0),E(1),E(2)......E(N-1),这些值通过利用A/D转换器56对激励进行采样而产生。8位的响应采样是N个值V(0),V(1),V(2)......V(N-1),这些值通过利用A/D转换器56进行A/D转换并被返回到微处理器54。连接器34的端子34-2提供一个公共端,这些值以其为参考。比例系数K用于说明激励和测量中涉及的不同的增益系数。激励频率是FHz。采样速率是MF,其中M例如具有5或更高的值。因而采样之间的间隔是1/MF秒。按照以下关系计算正弦值和余弦值的数组S(n)和C(n)并将其存于μP54的程序存储器中;
S(n)=sin(2πF(n/MF)),n=0 to(N-1)
C(n)=cos(2πF(n/MF)),n=0 to(N-1).
激励的实部和虚部分量计算如下:
响应的实部和虚部分量计算如下:
激励和响应的幅值被计算如下:
E=(Ere2+Eim2)1/2,
V=(Vre2+Vim2)1/2.
然后可以计算带的阻抗的幅值:
|Z|=KE/V.
还可以计算带阻抗的相位:
因而,使用图2所示的那种仪器32进行实际的葡萄糖浓度的测量方法如下。将血样加入生物传感器31。在仪器32的电子电路检测到在生物传感器31上的小滴的沉积之后,立即在连接器34的端子34-2和34-3之间施加例如1300Hz的交流信号,并由微处理器54通过测量激励和响应电压并使用比例系数从而获得电流来直接采样所得的电流。计算阻抗的幅值和相位角。使用这些值,查阅在微处理器54的程序存储器中的查看表从而确定血样的性质,并且确定是否具有使得继续进行化验的葡萄糖确定阶段的足够的血样量。如果没有,则化验结束,并把这个结果在仪器32的显示器上显示。如果具有足够的量使得能够继续进行葡萄糖确定,则对连接器34的两端34-2、34-3施加另一个频率例如10KHz的交流信号,并由微处理器54采样所得的电流。在这个第二频率下再次计算阻抗值和相位角,查阅在微处理器54的程序存储器中的第二查看表,求得指示的葡萄糖对实际的葡萄糖的校正系数。所述校正系数可以是常数例如0,用于表示指示的葡萄糖浓度小于一个第一指示的葡萄糖浓度,也可以是变量,例如表示指示的葡萄糖浓度大于所述第一指示的葡萄糖浓度。在任何情况下,所述的校正被存储,并例如基本上按照美国专利5243516、5288636、5352351、5385846、5508171中所述方法进行指示的葡萄糖浓度确定。一旦获得指示的葡萄糖浓度,则恢复所述的校正并应用于指示的葡萄糖浓度,从而获得实际的葡萄糖浓度,并在仪器32的显示器上被显示与/或仪器32的存储器中被存储。
本发明的另一个实施例如图3的部分方块图和部分示意图所示。其中,仪器132包括基本上和图2所示的带连接器30的类型相同的带连接器130。带连接器130被设计用于和生物传感器31实现接触。连接器134的第一端134-1通过10KΩ的电阻和开关136的一端136-1相连。开关136的一端136-2和差动放大器138的负输入端相连。放大器138的输出端和开关136的一端136-3相连。开关136的一端136-4和连接器134的一端134-2相连。加于生物传感器31上的直流激励由放大器138的输出建立。为了精确地设置生物传感器31的直流激励,来自端子134-1的反馈被返回到放大器138的负输入端。端子134-1和134-2连接生物传感器31上的一个公共电极,用于增加激励的精度。连接器134的端子134-3和差动放大器142的负输入端相连。放大器142的输出端通过7.5KΩ的电阻144和其负输入端相连。放大器142的正输入端和电路电源的公共点相连。放大器142的输出端和13位A/D转换器146的输入端相连。A/D转换器146的输出端和处理器148的输入端相连,处理器148具有支持执行在美国专利5243516、5288636、5352351、5385846、5508171中所述的指示葡萄糖测量功能的功能。处理器148的输出和8位D/A转换器150的输入端相连。D/A转换器150的输出端和放大器138的正输入端相连。所示的元件138,142,146和150的功能被包括在一个专用集成电路(ASIC)152中。虽然并不一定如此。
和端子134-1、134-2、以及134-3相连的生物传感器容器31的交流阻抗的实部和虚部分量的计算通过在所需的频率下在连接器134的端子134-2、134-3之间施加一个激励进行,例如利用低幅值的交流电压源150在合适的频率范围例如1Hz-100Hz,或10Hz-10KHz以扫描方式测量要被测量的一部分参数或全部,这些参数可以是,试样性质、试样量、试样温度/分血器、试样中的氧气浓度,或其它任何感兴趣的参数,这些参数具有足够的幅值和相位的改变,并且具有最佳的相互解耦,即,独立于容器31中的试样的其它成分的浓度。
在图3所示的实施例中,低幅值的交流电压激励在求和节点152和选择的直流偏移156相加,如果其可用于帮助确定感兴趣的干扰物的浓度的话。在所示的实施例中,交流电压和直流偏移在微处理器158的控制下产生,处理器158可以是用于管理上述的仪器132的功能的同一个微处理器,也可以是一个单独的微处理器。微处理器158被编程,根据要被其确定的干扰物的浓度对交流电压源150扫频和调节直流偏移。用这种方式,可以在最佳的频率范围和用于隔离特定的干扰物浓度的直流偏移下容易地确定干扰物的浓度。如果微处理器158用于控制扫描和偏移,则不需要提供从求和节点152到微处理器158的外部连接。因为微处理器158将要确定容器31的频率响应,和被确定的频率响应相关的频率可以在确定频率响应时存储在微处理器158的存储器中。不过,如果在确定频率响应时需要使用一些其它机理,也可以向微处理器158提供电压源150的输出频率以及直流偏移156的反馈。在任何情况下,由运算放大器164提供求和节点152和任何反馈通路160与容器31之间的隔离,放大器164的输入端和求和节点152相连,其输出端通过一个合适数值的电阻和放大器138的反馈通路相连,用于驱动容器31。类似地,容器31和微处理器158的频率响应确定输入端的隔离由和放大器142的输出相连的运算放大器166提供。按照已知的方式进行容器31的频率响应的确定,例如通过快速富氏变换(FFT)或者其它已知的微处理器158执行的频率响应确定程序。然后把容器31的频率响应特性和存储的要被确定其浓度的干扰物的频率响应特性比较,从而确定干扰物的浓度,并确定和指示的葡萄糖浓度相关的校正值,或者被存储用于以后的指示葡萄糖浓度的校正,或者立即和指示的葡萄糖浓度相结合,从而获得校正的葡萄糖浓度。
同样,一般地说,仪器132首先利用各个最佳解耦的交流幅值和各个最佳解耦的直流偏移,确定容器31在各个最佳解耦的频率范围内的各个频率响应,接着确定指示的葡萄糖浓度,接着对于这样确定的干扰物浓度校正指示的葡萄糖浓度。不过,如前所述,可能需要在这些干扰物的浓度被确定之前,在某个环境下利用某个干扰物使仪器132首先确定指示的葡萄糖浓度。
本发明的另一个实施例以图4的部分方块图和部分示意图示出。其中,仪器232包括和图2所示的带连接器30相同类型的带连接器230。带连接器230被设计用于和生物传感器31实现接触。连接器234的第一端234-1和差动放大器238的负输入端相连。放大器238的输出端和连接器234的一端234-2相连。加于生物传感器31上的直流激励由放大器238的输出建立。为了精确地设置生物传感器31的直流激励,来自端子234-1的反馈被返回到放大器238的负输入端。端子234-1和234-2连接生物传感器31上的一个公共电极,用于增加激励的精度。连接器234的端子234-3和差动放大器242的负输入端相连。放大器242的输出端通过8.25KΩ的电阻244和其负输入端相连。放大器242的正输入端和1.667V的基准电位相连。放大器242的输出端和14位A/D转换器246的输入端相连。A/D转换器246的输出端和处理器248的输入端相连,处理器248具有支持执行在美国专利5243516、5288636、5352351、5385846、5508171中所述的指示葡萄糖测量功能的功能。处理器248的输出端口和13位D/A转换器250的输入端相连。所示的放大器238和D/A转换器250被集成在一个器件上。放大器238具有一种开路关断方式,使得可以取消图2和图3所示的实施例中的开关36和136,借以在某种程度上简化电路。在其它方面,图4所示的电路的功能基本上和图2、3所示的电路的功能相同。D/A转换器250的输出端和放大器238的正输入端相连。所示的元件238、242、246、248、250被包括在一个ASIC 252中,虽然并不一定如此。D/A转换器250和A/D转换器246的精度和分辨率使得能够实现交流和直流带电流的测量,因而简化了电路。
同样,应当理解,在很大程度上,特定容器的物理和化学设计决定容器的电特性。因此,至少在同样程度上,这些物理化学设计特性决定容器对于每个干扰物和不同的试样类型以及不同的试样量的响应。例如,如果不参考特定容器的物理化学特性,则不能预计在哪个频率范围分血器的浓度和尿酸或者和胆红素的浓度能够最佳地解耦。还需要进行一些研究,用于确定这些最佳的频率范围。不过,一旦容器的物理化学特性为已知,这些研究将是常规的。
通过参看图5-7可以更好地理解减少用于获得血的葡萄糖浓度的补偿指示值所需的时间。图5表示利用标准的葡萄糖测试液在几个40秒内获得的葡萄糖浓度的结果。具有图5所示结果的化验没有进行上述的阻抗确定和对于温度与分血器的组合影响的补偿,而使用现有技术的方法对于温度和分血器进行补偿。图6表示利用标准的葡萄糖测试液在几个10秒内获得的葡萄糖浓度的结果。具有图6所示结果的化验没有进行上述的阻抗确定和对于温度与分血器的组合影响的补偿,而同样使用现有技术的方法对于温度和分血器进行补偿。图7表示利用标准的葡萄糖测试液在几个10秒内获得的葡萄糖浓度的结果。具有图7所示结果的化验使用上述的阻抗确定和对于温度与分血器的组合影响的补偿。比较这些图可以看出,利用上述的阻抗确定和补偿技术使得在这些测试液中获得可比的葡萄糖浓度确定所需的时间减少了4倍。
Claims (2)
1.一种可以和可处理的电化学传感器一起使用的仪器,用于检测和/或量化一种液体样本中的的分析物,包括装置,用于在检测到对***仪器中的测试带施加采样后,控制指示采样中的分析物的电流,其中在检测到施加采样后10秒或更短的时间测量电流。
2.根据权利要求1所述的仪器,其中在检测到施加采样后10秒或更短的时间测量电流。
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- 1998-12-21 EP EP98965424A patent/EP1042667B1/en not_active Expired - Lifetime
- 1998-12-21 CN CN2004100869422A patent/CN1598564B/zh not_active Expired - Lifetime
- 1998-12-21 CA CA002310021A patent/CA2310021C/en not_active Expired - Lifetime
- 1998-12-21 JP JP2000525749A patent/JP3260739B2/ja not_active Expired - Lifetime
- 1998-12-21 EP EP09005912.2A patent/EP2085779B1/en not_active Expired - Lifetime
- 1998-12-21 US US09/530,171 patent/US6645368B1/en not_active Expired - Lifetime
- 1998-12-21 WO PCT/US1998/027203 patent/WO1999032881A1/en active IP Right Grant
- 1998-12-21 CN CNB988125234A patent/CN1183384C/zh not_active Expired - Lifetime
- 1998-12-21 DE DE69840916T patent/DE69840916D1/de not_active Expired - Lifetime
- 1998-12-21 EP EP09005911.4A patent/EP2085778B1/en not_active Expired - Lifetime
- 1998-12-21 ES ES98965424T patent/ES2326145T3/es not_active Expired - Lifetime
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- 1998-12-22 AR ARP980106611A patent/AR015206A1/es active IP Right Grant
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US10067082B2 (en) | 2004-02-06 | 2018-09-04 | Ascensia Diabetes Care Holdings Ag | Biosensor for determining an analyte concentration |
CN101273266B (zh) * | 2005-09-30 | 2012-08-22 | 拜尔健康护理有限责任公司 | 门控伏特安培法 |
US9835582B2 (en) | 2005-09-30 | 2017-12-05 | Ascensia Diabetes Care Holdings Ag | Devices using gated voltammetry methods |
US10670553B2 (en) | 2005-09-30 | 2020-06-02 | Ascensia Diabetes Care Holdings Ag | Devices using gated voltammetry methods |
US11435312B2 (en) | 2005-09-30 | 2022-09-06 | Ascensia Diabetes Care Holdings Ag | Devices using gated voltammetry methods |
CN101495855B (zh) * | 2006-07-05 | 2013-04-17 | 松下电器产业株式会社 | 液体试样测定方法及装置 |
US10190150B2 (en) | 2006-10-24 | 2019-01-29 | Ascensia Diabetes Care Holdings Ag | Determining analyte concentration from variant concentration distribution in measurable species |
US11091790B2 (en) | 2006-10-24 | 2021-08-17 | Ascensia Diabetes Care Holdings Ag | Determining analyte concentration from variant concentration distribution in measurable species |
US9933385B2 (en) | 2007-12-10 | 2018-04-03 | Ascensia Diabetes Care Holdings Ag | Method of using an electrochemical test sensor |
US10690614B2 (en) | 2007-12-10 | 2020-06-23 | Ascensia Diabetes Care Holdings Ag | Method of using an electrochemical test sensor |
CN105849542A (zh) * | 2013-12-23 | 2016-08-10 | 生命扫描苏格兰有限公司 | 具有工作范围测试条模拟电路块的手持式测试仪 |
CN106596688A (zh) * | 2016-12-21 | 2017-04-26 | 三诺生物传感股份有限公司 | 一种在电化学测试***中区分质控液和实际样品的方法及识别装置控制器和识别*** |
Also Published As
Publication number | Publication date |
---|---|
JP3260739B2 (ja) | 2002-02-25 |
AR015206A1 (es) | 2001-04-18 |
CN1303478A (zh) | 2001-07-11 |
EP1042667B1 (en) | 2009-06-17 |
CN1598564B (zh) | 2010-04-21 |
EP1042667A4 (en) | 2001-05-09 |
WO1999032881A1 (en) | 1999-07-01 |
AU2089299A (en) | 1999-07-12 |
JP2001527215A (ja) | 2001-12-25 |
US20030064525A1 (en) | 2003-04-03 |
EP2085779B1 (en) | 2017-11-01 |
US6645368B1 (en) | 2003-11-11 |
DE69840916D1 (de) | 2009-07-30 |
BR9814386B1 (pt) | 2009-08-11 |
EP1042667A1 (en) | 2000-10-11 |
CN1183384C (zh) | 2005-01-05 |
AU738325B2 (en) | 2001-09-13 |
BR9814386A (pt) | 2000-10-10 |
CA2310021C (en) | 2005-02-15 |
NO20003228L (no) | 2000-06-21 |
NO20003228D0 (no) | 2000-06-21 |
EP2085779A1 (en) | 2009-08-05 |
ES2326145T3 (es) | 2009-10-01 |
EP2085778A1 (en) | 2009-08-05 |
EP2085778B1 (en) | 2017-11-29 |
TW458769B (en) | 2001-10-11 |
CA2310021A1 (en) | 1999-07-01 |
US20040005716A9 (en) | 2004-01-08 |
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