CN101103271B - 用于生物传感器的新的电极设计 - Google Patents
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Abstract
用于当检验条配合到适当的检验仪表时测量生物流体内的感兴趣的信号的检验条，其中，检验条和检验仪表包括鉴定检验条迹线的完整性、测量检验条迹线的寄生电阻、和在施加到检验条的电压内提供补偿以解决检验条迹线内的寄生电阻损耗的结构。另外，导电迹线定位为确保存在于检验条上的全部电极和迹线的结构询问。
Description
技术领域
本发明涉及用于测量诸如那些与生物流体内的分析物(诸如血糖)的浓度相关的以及那些与对分析物浓度信号的干扰(诸如在血糖的情况中的血细胞比容和温度)相关的信号的设备。本发明更特定地涉及用于生物传感器检验条的质量保证的系统和方法。
背景技术
测量生物流体中的物质的浓度是用于诊断和治疗许多医学状态的重要的工具。例如，对诸如血液的体液中的葡萄糖的测量对于有效地治疗糖尿病是及其重要的。
糖尿病的疗法通常包括两种类型的胰岛素治疗：基础的，和进餐时。基础的胰岛素指的是连续的，例如逐渐释放的胰岛素，经常在睡觉前进行。进餐时胰岛素治疗提供附加的剂量的更快作用的胰岛素以调节由包括糖和碳水化合物的新陈代谢的各种因素导致的血糖的波动。对血糖波动的适当的调节需要准确地测量血液中的葡萄糖的浓度。无法准确地测量血液中的葡萄糖的浓度能够产生严重的并发症，包括失明和丧失手足循环，其能够最终导致糖尿病人丧失使用他或她的手指、手、脚等等的能力。
已知用于确定血液样本中的诸如例如葡萄糖的分析物的浓度的多种方法。这样的方法通常属于两种分类其中之一：光学方法和电化学方法。光学方法通常包括光谱学以观察通过分析物的浓度导致的流体内的光谱偏移，通常与当与分析物结合时产生已知的颜色的试剂协同。电化学方法通常依靠电流(电流分析法)、电位(电位分析法)或积聚的电荷(库仑分析法)和分析物浓度之间的相互关系，通常与当与分析物结合时产生电荷载体的试剂协同。参看例如Columbus的美国专利No.4,233,029、Pace的4,225,410、Columbus的4,323,536、Muggli的4,008,448、Lilja等人的4,654,197、Szuminsky等人的5,108,564、Nankai等人的5,120,420、Szuminsky等人的5,128,015、White的5,243,516、Diebold等人的5,437,999、Pollmann等人的5,288,636、Carter等人的5,628,890、Hill等人的5,682,884、Hill等人的5,727,548、Crismore等人的5,997,817、Fujiwara等人的6,004,441、Priedel等人的4,919,770、和Shieh的6,054,039，以上专利特此全文加入。用于实施检验的生物传感器典型地为其上具有与生物流体内的感兴趣的分析物化学地反应的试剂的一次性的检验条。检验条配合到非一次性的检验仪表，使得检验仪表能够测量分析物和试剂之间的反应以确定和为使用者显示分析物的浓度。
图1示意性地示出了典型的现有技术的一次性的生物传感器检验条，通常指示为10(参看例如转让给与本申请相同的受让人并且作为参考加入这里的美国专利No.4,999,582和5,438,271)。检验条10形成在非导电的基底12上，在其上形成导电区域14、16。化学试剂18在检验条10的一个端部施加在导电区域14、16上。试剂18将以当电压电位施加到测量电极14a和16a之间时能够被检测到的方式与生物样本内的感兴趣的分析物反应。
因此，检验条10具有反应区20，包含直接与包含将要确定其在样本内的浓度的分析物的样本接触的测量电极14a、16a。在电流分析法或库仑分析法电化学测量系统中，反应区20内的测量电极14a、16a被联结到将电位施加到测量电极并且测量电化学传感器对此电位的响应(例如，电流，阻抗，电荷，等等)的电子电路(典型地在检验条10被插入其中的检验仪表(没有示出)内，如在本领域中众所周知的)。此响应与分析物的浓度成比例。
检验仪表在检验条10的接触区22内的接触垫14b、16b处接触检验条10。接触区22定位为稍微远离检验区20，通常(但不总是)在检验条10的相反的端部。导电迹线14c、16c将接触区22内的接触垫14b、16b联结到反应区20内的分别的测量电极14a、16a。
特别是对于其中的电极、迹线和接触垫由导电薄膜(例如，贵金属，碳墨，和银膏，作为非限制性的示例)组成的生物传感器10，将接触区22连接到反应区20的导电迹线14c、16c的电阻率能够相当于数百欧姆或更大。此寄生电阻导致沿迹线14c、16c的长度的电位降，使得出现在反应区20内的测量电极14a、16a的电位比通过检验仪表施加到接触区22内的检验条10的接触垫14b、16b的电位小得多。因为在反应区20内发生的反应的阻抗可能在迹线14c、16c的寄生电阻的数量的量级，由于通过迹线导致的I-R(电流x电阻)降，测量的信号可能具有相当大的偏移。如果不同检验条之间此偏移不同，噪声附加到测量结果。此外，对检验条10的物理损害，诸如磨损、破裂、划痕、化学降解等等，可能在制造、运送、存储和/或使用者误操作期间发生。这些因素可能损害导电区域14、16达到它们呈现非常高的电阻或甚至开路的程度。这样的迹线电阻的增加可能阻止检验仪表执行准确的检验。
发明内容
用于当检验条配合到适当的检验仪表时测量生物流体内的感兴趣的信号的检验条，其中，检验条和检验仪表包括鉴定检验条迹线的完整性、测量检验条迹线的寄生电阻、和在施加到检验条的电压内提供补偿以解决检验条迹线内的寄生电阻损耗的结构。另外，导电迹线定位为确保存在于检验条上的全部电极和迹线的结构询问。
附图说明
下面将参考附图仅作为示例更进一步地描述本发明，其中：
图1为用于测量生物流体内的感兴趣的分析物的浓度的典型的现有技术的检验条的示意性的平面图。
图2为根据本发明的第一实施例的检验条的示意性的平面图。
图3为用于与图2所示的第一实施例的检验条一起使用的第一实施例的电子检验电路的原理图。
图4为用于测量生物流体内的感兴趣的分析物的浓度的第二典型的检验条的分解的装配图。
图5示出了适用于与本发明一起使用的烧蚀设备的视图。
图6为示出了第二掩模的图5所示的激光烧蚀设备的视图。
图7为适用于与本发明一起使用的烧蚀设备的视图。
图8为根据本发明的第二实施例的检验条的示意性的平面图。
图9为用于与图8所示的第二实施例的检验条一起使用的第二实施例的电子检验电路的原理图。
图10为用于与图8所示的第二实施例的检验条一起使用的第三实施例的电子检验电路的原理图。
图11为检验条的第三实施例的示意性的平面图。
图12为检验条的第四实施例的示意性的平面图。
具体实施方式
为了促进理解本发明的原理的目的，现在将参考在附图中示出的实施例，并且将使用专用语言来描述该实施例。然而，应该理解不打算限制本发明的范围。本发明涉及的领域中的普通技术人员通常地想到的说明的装置的更改和修改、和如在这里说明的本发明的原理的更进一步的应用是被预想的并且希望被保护。特别是，虽然关于血糖仪表来讨论本发明，预想本发明能够与用于测量其它分析物和其它样本类型的装置一起使用。对于本领域中的普通技术人员显而易见，这样的替代的实施例需要对这里讨论的实施例进行某些适应。
虽然本发明的系统和方法可以与具有多种设计并且用多种构造技术和工艺制造的检验条一起使用，在图2中示意性地示出了本发明的第一实施例的电化学检验条，并且通常指示为200。与检验条10大致相同的检验条200的部分用相似的参考指示符标记。参考图2，检验条200包括由在其顶部表面涂敷有50nm导电金层(例如通过溅射或气相沉积，作为非限制性的示例)的350μm厚的聚酯(诸如可以从DuPont获得的Melinex329)的不传导的片形成的底部基底12。因此，电极、连接迹线和接触垫随后通过例如激光烧蚀工艺在导电层内形成图案。激光烧蚀工艺的一个实施例依靠通过石英上铬的掩模的准分子激光执行。通过铬限定的掩模图案导致激光场的一部分被反射，同时允许场的其它部分通过石英，在金上形成图案，金在被激光接触的地方蒸发。在下文中更加详细地描述了激光烧蚀工艺。例如，工作电极214a、反电极216a、和反感测电极224a可以如图所示般形成并且依靠分别的迹线214c、216c和224c联结到分别的测量接触垫214b、216b和224b。这些接触垫214b、216b和224b在检验条200上提供导电的区域，以一旦检验条200被插入检验仪表，被检验仪表(没有示出)的连接器触点接触，如在本领域中众所周知的。
图2和3示出了通过允许补偿检验条的反电极线内的寄生I-R降对现有技术的检验条设计改进的本发明的实施例。应该理解，图2所示的检验条200与图1所示的现有技术的检验条10大致相同，除了添加了反感测电极224a、接触垫224b、和迹线224c。反感测线224的提供允许检验仪表(如下文中所述)补偿接触垫216b、224b之间的寄生电阻。注意，当与图3所示的电路一起使用时，图2所示的实施例仅补偿检验条200的反电极侧上的I-R降。使用此电路不能检测检验条200的工作电极侧上的寄生电阻，然而其也可以根据需要被复制在工作电极侧上，如本领域中的普通技术人员通过参考本披露物可以明白的。在下文中提出用于补偿在检验条的工作侧和反侧二者全部上的寄生电阻的更进一步的方法。因此，图2所示的反感测线允许检验仪表补偿反线216内的任何寄生电阻电位降，如参考图3更加详细地描述的。
现在参考图3，示出了容纳在检验仪表内的第一实施例的电极补偿电路(通常指示为300)的电路原理图。如图所示，当检验条200被插入检验仪表时，电路联结到接触垫214b、216b和224b。如本领域中的普通技术人员应该理解的，电压电位施加到反电极接触垫216b，这将在反电极216a和工作电极214a之间产生与施加到试剂18的生物样本中存在的分析物的量成比例的电流。来自工作电极214a的电流依靠工作电极迹线214c传输到工作电极接触垫214b并且提供给电流-电压放大器310。通过模拟-数字转换器(A/D)312将放大器310的模拟输出电压转换为数字信号。微处理器314随后根据之前存储的程序处理此数字信号，以便确定施加到检验条200的生物样本内的分析物的浓度。依靠诸如液晶显示器(LCD)屏幕的适当的输出装置316为使用者显示此浓度。
微处理器314还输出指示施加到反电极接触垫216b的电压电位的数字信号。通过数字-模拟转换器(D/A)318将此数字信号转换为模拟电压信号。D/A318的模拟输出施加到运算放大器320的第一输入。运算放大器320的第二输入联结到反感测电极接触垫224b。运算放大器320的输出联结到反电极接触垫216b。
运算放大器320以电压跟随器构造连接，其中，放大器将调节其输出(在其操作的物理限制内)直到在其第二输入出现的电压等于在其第一输入出现的指令电压。运算放大器320的第二输入为高阻抗输入，因此，大致没有电流在反感测线224上流动。因为大致没有电流流动，反感测线224内的任何寄生电阻不会导致电位降，并且出现在运算放大器320的第二输入处的电压与在反感测电极224a处的电压大致相同，由于它们物理上的接近性，其又与出现在反电极216a处的电压大致相同。因此，运算放大器320作用为改变施加到反电极接触垫216b的电压电位，直到出现在反电极216a处的实际电压电位(当通过反感测线224反馈时)等于通过微处理器314指令的电压电位。因此，运算放大器320自动地补偿由反电极迹线216c内的寄生电阻导致的任何电位降，并且出现在反电极216a处的电位为希望的电位。因此，使得从通过工作电极产生的电流计算生物样本内的分析物浓度更加准确，因为产生电流的电压的确与通过微处理器314指令的电压相同。在没有补偿由电路300提供的寄生电阻电压降的情况下，微处理器314会在错误地假定指令电压实际地施加到反电极216a的情况下分析作为结果的电流。
许多方法可以用于制备具有多个电极的检验条，诸如作为非限制性的示例的碳墨印刷、银膏丝网印制、划线金属化的塑料、电镀、化学镀、和光化学刻蚀。这里描述的一种制备具有附加的电极感测线的检验条的方法为通过使用激光烧蚀技术。使用这些技术制备用于生物传感器的电极的示例在2001年5月25日提出的题目为“Biosensorswith Laser Ablation Electrodes with a Continuous Coverlay Channel”的美国专利申请序号09/866,030和在1999年10月4日提出的题目为“Laser Defined Features for Patterned Laminates and Electrode”的美国专利申请序号09/411,940中描述，全部披露物在这里作为参考加入。激光烧蚀对于制备根据本发明的检验条是有用的，因为其允许以可重复的方式准确地制造具有非常小的特征尺寸的导电区域。激光烧蚀提供用于在不增加检验条的尺寸的情况下将本发明的额外的感测线附加到检验条的方法。
本发明希望提供电部件相对于彼此并且相对于整个生物传感器的准确的布置。在一个实施例中，至少部分地通过使用通过掩模或其它具有对于电部件的精确的图案的装置执行的宽场激光烧蚀实现部件的相对的布置。这允许准确地定位邻近的边缘，这通过对于边缘的平滑度的紧公差更进一步地增强。
图4示出了用于说明本发明的激光烧蚀工艺有用的简单的生物传感器401，包括基底402，限定了电极系统的导电材料403形成在基底402上，该电极系统包括第一电极组404和第二电极组405和分别地对应的迹线406、407和接触垫408、409。注意，这里使用生物传感器401的目的为说明激光烧蚀工艺，并且其没有示出为结合本发明的感测线。导电材料403可以包含纯的金属或合金或其它为金属导体的材料。在一些实施例中，导电材料对于用于形成电极的激光的波长是吸收性的并且厚度服从迅速和精确的处理。非限制性的示例包括铝、碳、铜、铬、金、铟锡氧化物(ITO)、钯、铂、银、锡氧化物/金、钛、它们的混合物、和这些元素的合金或金属化合物。在一些实施例中，导电材料包括贵金属或合金或它们的氧化物。其它实施例使用诸如金、钯、铝、钛、铂、ITO和铬的导电材料。导电材料的厚度在从大约10nm到80nm的范围内。一些实施例使用在30nm到70nm之间的厚度范围，其它使用在50nm的厚度。应该理解，导电材料的厚度取决于材料的透射性质和与生物传感器的使用相关的其它因素。
虽然没有示出，应该理解，作为结果的有图案的导电材料能够涂敷或镀有附加的金属层。例如，导电材料可以为铜，其随后用激光烧蚀为电极图案；随后，可以为铜镀钛/钨层，并且随后金层，以形成希望的电极。在大多数实施例中，使用在基部402上的单一层导电材料。虽然通常不是必要的，如本领域中众所周知的，通过使用诸如铬镍或钛的种子层或辅助层，可能增强导电材料到基部的附着力。在一些实施例中，生物传感器401具有单一层金、钯、铂或ITO。
分别在图4、6和7中示出，生物传感器401说明性地使用两个设备10、10’制造。应该理解，除非另有说明，设备410、410’以相似的方式操作。首先参考图5，通过将具有80nm金叠层的大约40mm宽的带状物420的卷供给入定制配合的宽场激光烧蚀设备410来制造生物传感器401。设备410包括产生激光412的束的激光源411、镀铬的石英掩模414、和光学器件416。应该理解，虽然示出的光学器件416为单一透镜，光学器件416可以为合作以使得光412为预先确定的形状的多种透镜。
适合的烧蚀设备410(图5-6)的非限制性的示例为可以从LPKFLaser Electronic GmbH，of Garbsen，Germany购买到的定制的MicrolineLaser200-4激光系统，其结合了可以从Lambda Physik AG，Gottingen，Germany购买到的LPX-400、LPX-300或LPX-200激光系统和可以从Infinite Graphics，Minneapolis，MN购买到的镀铬的石英掩模。
对于MicrolineLaser200-4激光系统(图5-6)，激光源411为LPX-200KrF-UV-laser。然而，应该理解，根据本披露物，能够使用更高波长的UV激光。激光源411工作在248nm，脉冲能量为600mJ，并且脉冲重复频率为50Hz。激光束412的强度可以通过电介质光束衰减器(没有示出)在3％和92％之间无限地调节。束轮廓为27×15mm2(0.62平方英寸)并且脉冲持续时间为25ns。掩模414上的布局通过光学元件光束扩展器、均化器、和场镜(没有示出)均匀地投射。已经通过测量能量曲线确定了均化器的性能。成像光学器件416将掩模414的结构传递到带状物420上。成像比率为2:1以一方面允许移除大的区域，另一方面保持能量密度低于施加的铬掩模的烧蚀点。虽然说明了2:1的成像，应该理解，根据本披露物，根据希望的设计需求，任何数量的替代的比率是可能的。带状物420如箭头425所示般运动以允许接连地烧蚀多个布局段。
掩模414的定位、带状物420的运动、和激光能量由计算机控制。如图5所示，激光束412投射到要烧蚀的带状物420上。通过掩模414的空白区域或窗418的光412从带状物420烧蚀金属。掩模414的铬涂敷的区域424阻断激光412并且防止在那些区域烧蚀，在带状物420的表面上导致金属化的结构。现在参考图6，电部件的完整的结构可能需要通过第二掩模414’的附加的烧蚀步骤。应该理解，根据本披露物，根据光学器件和要烧蚀的电部件的尺寸，仅单一烧蚀步骤或多于两个烧蚀步骤可以是必要的。此外，应该理解，根据本披露物，代替多个掩模，可以在同一掩模上形成多个场。
特别地，适合的烧蚀设备410’(图7)的第二非限制性的示例为可以从LPKF Laser Electronic GmbH，of Garbsen，Germany购买到的定制的激光系统，其结合了可以从Lambda Physik AG，Gottingen，Germany购买到的Lambda STEEL(稳定能量准分子激光)激光系统和可以从Infinite Graphics，Minneapolis，MN购买到的镀铬的石英掩模。激光系统特征为在308nm波长达到1000mJ脉冲能量。此外，激光系统的频率为100Hz。设备410’可以形成为如图5和6所示的以两次通过生产生物传感器，但是在一些实施例中，其光学器件允许以25ns单一通过形成10×40mm图案。
虽然不希望被特定的理论束缚，相信通过掩模414、414’、414”的激光脉冲或束412在带状物420上的表面402的小于1μm内被吸收。束412的光子的能量足够导致光解作用和在金属/聚合物分界面处的化学键的迅速断裂。相信此迅速的化学键断裂导致吸收区内的突然的压力增加并且促使材料(金属膜403)从聚合物基部表面喷射。因为典型的脉冲持续时间为20-25纳秒左右，与材料的互相作用非常迅速地发生并且对导电材料403的边缘和周围结构的热损害最小。和本发明预想的一样，作为结果的电部件的边缘具有高边缘质量和准确的布置。
用于从带状物420移除或烧蚀金属的注量能量取决于形成带状物420的材料、金属膜到基部材料的附着、金属膜的厚度、并且可能取决于用于将膜布置到基部材料上的工艺，即支撑和气相沉积。对于金在KALADEX
上的注量级范围为从大约50到大约90mJ/cm2，在聚酰亚胺上为大约100到大约120mJ/cm2，并且在MELINEX上在大约60到大约120mJ/cm2。应该理解，根据本披露物，小于或大于上面提到的注量级的注量级可能适用于其它基础材料。
通过使用掩模414、414’实现带状物420的区域的图案形成。每个掩模414、414’示例性地包括包含要形成的电极部件图案的预先确定的部分的精确的两维图的掩模场422。图5示出了包括接触垫和迹线的一部分的掩模场422。如图6所示，第二掩模414’包含迹线的第二对应的部分和包含指状物的电极图案。如前所述，应该理解，根据要烧蚀的区域的尺寸，掩模414能够包含电极图案(图7)的完整的图，或与根据本披露物的那些在图5和6中示出的不同的图案的部分。预想在本发明的一个方面，一次激光烧蚀检验条上的电部件的整个图案，即，宽场包围检验条的整个尺寸(图7)。在替代物中，并且如图5和6所示，接连地实现整个生物传感器的部分。
虽然将在下文中讨论掩模414，应该理解，除非另有说明，讨论将同样适用于掩模414’、414”。参考图5，被铬保护的掩模场422的区域424将阻断激光束412投射到带状物420。掩模场422内的空白区域或窗418允许激光束412通过掩模414并且冲击带状物420的预先确定的区域。如图5所示，掩模场422的空白区域418对应导电材料403要从其被移除的带状物420的区域。
此外，掩模场422的长度通过线430示出并且宽度通过线432示出。给定LPX-200的成像比率为2:1，应该理解，掩模的长度30为作为结果的图案的长度434的长度的两倍，并且掩模的宽度432为带状物420上的作为结果的图案的宽度436的宽度的两倍。光学器件416减小冲击带状物420的激光束412的尺寸。应该理解，根据本披露物，掩模场422和作为结果的图案的相对尺寸可以改变。掩模414’(图6)用于完成电部件的两维图。
继续参考图5，在激光烧蚀设备410中，准分子激光源411发射束412，束412通过石英上铬的掩模414。掩模场422导致激光束412的部分反射，同时允许束的其它部分通过，在金膜上被激光束412冲击的地方形成图案。应该理解，带状物420可以相对于设备410静止或在通过设备410的辊上连续地运动。因此，带状物420的非限制性的运动速率可以从大于0m/min到大约100m/min，并且在一些实施例中从大约30m/min到大约60m/min。应该理解，根据本披露物，带状物420的运动速率仅受到选择的设备410的限制并且依靠激光源411的脉冲持续时间可以超过100m/min。
一旦在带状物420上形成掩模414的图案，重绕带状物并且将其再次供给通过设备410，使用掩模414’(图6)。应该理解，替代地，根据本披露物，激光设备410可以串联定位。从而，通过使用掩模414、414’，能够使用重复步骤工艺为带状物420的大的区域形成图案，包括在相同的掩模区域内的多个掩模场422，以使得能够在基部的基底上经济地形成复杂的电极图案和其它电部件、形成电极部件的精确的边缘、和从基部材料移除较大量金属膜。
图8和9所示的本发明的第二实施例通过提供对于检验条上的工作电极和反电极导线二者全部的I-R降的补偿改进现有技术。现在参考图8，示意性地示出了本发明的第二实施例的检验条构造，通常指示为800。检验条800包括用50nm导电金层(例如通过作为非限制性的示例的溅射或气相沉积)涂敷在其顶部表面上的底部基底12。因此，电极、连接迹线和接触垫随后通过如上文中所述的激光烧蚀工艺在导电层内形成图案。例如，工作电极814a、工作感测电极826a、反电极216a、和反感测电极224a可以如图所示形成并且通过分别的迹线814c、826c、216c和224c联结到分别的测量接触垫814b、826b、216b和224b。这些接触垫814b、826b、216b和224b在检验条800上提供导电区域，以一旦检验条800插入检验仪表，被检验仪表(没有示出)的连接器触点接触。
应该理解，图8所示的检验条800与图2所示的第一实施例的检验条200大致相同，除了添加了工作感测电极826a、接触垫826b、和迹线826c。工作感测线826的提供允许检验仪表补偿通过到接触垫814b和216b的连接的接触电阻导致的任何I-R降，并且补偿迹线814c和216c的迹线电阻。
现在参考图9，示出了容纳在检验仪表内的第二实施例的电极补偿电路(通常指示为900)的电路原理图。如图所示，当检验条800插入检验仪表时，电路联结到接触垫826b、814b、216b和224b。如本领域中的普通技术人员应该理解的，电压电位施加到反电极接触垫216b，这将在反电极216a和工作电极814a之间产生与施加到试剂18的生物样本中存在的分析物的量成比例的电流。来自工作电极814a的电流通过工作电极迹线814c传输到工作电极接触垫814b并且提供给电流-电压放大器310。通过A/D312将放大器310的模拟输出电压转换为数字信号。微处理器314随后根据之前存储的程序处理此数字信号，以便确定施加到检验条800的生物样本内的感兴趣的分析物的浓度。依靠LCD输出装置316为使用者显示此浓度。
微处理器314还输出指示施加到反电极接触垫216b的电压电位的数字信号。通过D/A318将此数字信号转换为模拟电压信号。D/A318的模拟输出施加到运算放大器320的第一输入。运算放大器320的第二输入联结到运算放大器910的输出。运算放大器910以使用测量放大器的不同的放大器构造连接。运算放大器910的第一输入联结到工作感测电极接触垫826b，同时运算放大器910的第二输入联结到反感测电极接触垫224b。运算放大器320的输出联结到反电极接触垫216b。
运算放大器320以电压跟随器构造连接，其中，放大器将调节其输出(在其操作的物理限制内)直到在其第二输入出现的电压等于在其第一输入出现的指令电压。运算放大器320的全部输入为高阻抗输入，因此，大致没有电流在反感测线224或工作感测线826内流动。因为大致没有电流流动，反感测线224或工作感测线826内的任何寄生电阻不会导致电位降，并且跨越运算放大器910的输入出现的电压与跨越测量单元(即，跨越反电极216a和工作电极814a)的电压大致相同。因为运算放大器910以不同的放大器构造连接，其输出表示跨越测量单元的电压。
因此，运算放大器320作用为改变其输出(即，施加到反电极接触垫216b的电压电位)，直到跨越测量单元出现的实际的电压电位等于通过微处理器314指令的电压电位。因此，运算放大器320自动地补偿由反电极迹线216c、反电极接触件216b、工作电极迹线814c、和工作电极接触件814b内的寄生电阻导致的任何电位降，并且因此，跨越测量单元出现的电位为希望的电位。因此，使得从通过工作电极产生的电流计算生物样本内的分析物的浓度更加准确。
图10连同图8示出了本发明的第三实施例，其通过提供对于工作电极线和反电极线二者全部上的I-R降的补偿以及提供工作电极线和反电极线二者全部上的电阻不高于预先确定的阈值的验证以便确保检验仪表能够补偿I-R降来改进现有技术。现在参考图10，示出了容纳在检验仪表内的第三实施例的电极补偿电路(通常指示为1000)的电路原理图。电极补偿电路1000与图8所示的检验条800一起工作。如图所示，当检验条800插入检验仪表时，电路联结到接触垫826b、814b、216b和224b。如本领域中的普通技术人员应该理解的，电压电位施加到反电极接触垫216b，这将在反电极216a和工作电极814a之间产生与施加到试剂18的生物样本中存在的分析物的量成比例的电流。来自工作电极814a的电流通过工作电极迹线814c传输到工作电极接触垫814b并且提供给电流-电压放大器310。电流-电压放大器310的输出施加到当开关1004处于闭合位置时构造为具有单位增益的缓冲器的测量放大器1002的输入。通过A/D312将放大器1002的模拟输出电压转换为数字信号。微处理器314随后根据之前存储的程序处理此数字信号，以便确定施加到检验条800的生物样本内的分析物的浓度。依靠LCD输出装置316为使用者显示此浓度。
微处理器314还输出指示施加到反电极接触垫216b的电压电位的数字信号。通过D/A318将此数字信号转换为模拟电压信号。D/A318的模拟输出施加到运算放大器320的输入，当开关1006处于示出的位置时，运算放大器320构造为电压跟随器。运算放大器320的输出联结到反电极接触垫216b，这将允许测量施加到试剂18的生物流体样本。此外，开关1006、1008和1010如图10所示定位，电路如图9所示构造并且可以用于如上文中关于图9描述地自动地补偿寄生和接触电阻。
为了测量反电极线216内的寄生电阻的量，开关1008布置在图10所示的位置，开关1006布置在与图10所示相反的位置，而开关1010闭合。因此，运算放大器320作用为具有单位增益的缓冲器并且将电压电位通过已知的电阻Rnom施加到反电极接触垫216b。此电阻导致电流在反电极线216和反感测线224内流动，其通过现在通过开关1010联结到电流感测线的电流-电压放大器310感测。电流-电压放大器310的输出通过A/D312提供给微处理器314。因为Rnom的值已知，微处理器314能够计算反感测线224和反电极线216内的任何寄生电阻的值。此寄生电阻值能够与存储在检验仪表内的预先确定的阈值比较，以确定检验条800是否发生物理损害或存在于接触垫上的不传导的累积物是否已经达到检验条800不能可靠地用于执行检验的程度。在这样的情形中，检验仪表可以编程序为告知使用者在继续检验之前应该将替代的检验条插入检验仪表。
为了测量工作电极线814内的寄生电阻的量，开关1006和1008布置在与图10所示相反的位置，而开关1010打开。因此，运算放大器320作用为具有单位增益的缓冲器并且将电压电位通过已知的电阻Rnom施加到工作感测接触垫826b。此电阻导致电流在工作感测线826和工作电极线814内流动，其通过电流-电压放大器310感测。电流-电压放大器310的输出通过A/D312提供给微处理器314。因为Rnom的值已知，微处理器314能够计算工作感测线826和工作电极线814内的任何寄生电阻的值。此寄生电阻值能够与存储在检验仪表内的预先确定的阈值比较，以确定检验条800是否发生物理损害或存在于接触垫上的不传导的累积物是否已经达到检验条800不能可靠地用于执行检验的程度。在这样的情形中，检验仪表可以编程序为告知使用者在继续检验之前应该将替代的检验条插入检验仪表。
图11示意性地示出了具有对图8所示的工作电极和反电极二者全部的I-R降补偿的根据本发明的第三实施例的检验条。第三实施例的检验条1100包括在其顶部表面涂敷有50nm导电层(例如通过溅射或气相沉积，作为非限制性的示例)的底部基底12。因此，电极、连接迹线和接触垫随后通过如上文中所述的激光烧蚀工艺在导电层内形成图案。如本领域中的普通技术人员容易明白的，图11所示的检验条与图8所示的检验条相似。与图8所示的检验条不同，反感测线224和工作感测线826不延伸到反应区20内。另外，反电极216a包括多个指状物1104而不是仅一个。在其它实施例中，工作电极814a也能够包括多个指状物1104。另外，毛细空间1102提供为用于将样本抽到反应区20内，使得样本覆盖电极216a和814a的部分。
图11所示的设计固有地包括一些性能限制。线A-A、B-B、C-C等等为不能被询问以确定电极216a、814a或指状物1104的结构整体性是否存在故障的区域。例如，这些区域内的任何物理缺陷，诸如增加迹线电阻或完全切断迹线的划痕，不能通过在上文中描述的质量保证检查检测到。这是由于感测线224c、826c在检验仪表和线A-A之间的点结合分别的电极迹线216c、814c的事实。因此，在线A-A和F-F之间的对检验条1100的任何损害在质量保证检验回路外部并且将不会影响在上文中描述的I-R降补偿或寄生电阻阈值检验。因此，感测线826、224的定位阻止在获得并且分析流体样本之前完全地检验检验条1100的功能。因此，对流体样本的希望的特性的最终测量结果可能是错误的。
图12示出了更加稳固的检验条设计，以克服图11所示的设计的缺点。检验条1200包括工作感测线826和反感测线224，其具有它们与分别的电极814a、216a相交的分别的点1206、1208。工作感测线826和反感测线224为形成在基底12上的导电迹线。点1206和用于检验条1200的检验仪表内的电源之间的距离(在与检验条的纵轴线平行的平面内测量)大于或等于试剂18内的工作电极814a的部分上的任何点和电源之间的距离。相似地，点1208和用于检验条1200的电源之间的距离大于或等于试剂18内的反电极216a的部分上的任何点和电源之间的距离。使得工作感测线826和反感测线224在这些位置包括点1206、1208使得能够询问电源和测量电极指状物之间的检验条1200上的每个点关于其结构整体性和寄生电阻。如能够结合图3从图12看出的，电源经由定位在接触区(22)内的接触垫联结到检验条。因此，相交的点(1206，1208)和接触区(22)之间的距离大于或等于电极(814a，216a)上的任何点和接触区(22)之间的距离。
与图11所示的设计不同，图12所示的设计定位感测线224、826以使得能够询问电极216a、814a和相关的指状物的结构缺陷。如果发现缺陷，能够补偿或指示该缺陷并且能够除掉检验条1200并且使用新的检验条。这有助于消除对流体样本的希望的特性的测量结果中的错误。
在这里引用的全部出版物、在先的申请、和其它文献在这里全文作为参考加入，如同每个已经作为参考单独地加入并且完全地陈述。
虽然在附图中和前面的描述中已经详细地示出和描述了本发明，这些描述应该被认为是说明性的并且在性质上不是限制性的。仅示出了认为是有助于理解的某些实施例。希望保护在本发明的精神范围内的全部改变和修改。
Claims (10)
1.一种通过电源供电的电化学检验条，其包括：
第一测量电极(814a)，和
操作地联结到第一测量电极的第一导电迹线(826)，其中，在第一导电迹线上的至少一个点和用于接触电源的接触区(22)之间的距离大于或等于在所述第一测量电极上的任何点和用于接触电源的接触区(22)之间的距离。
2.根据权利要求1所述的检验条，还包括
第二测量电极(216a)，和
操作地联结到第二测量电极的第二导电迹线(224)，其中，在第二导电迹线上的至少一个点和用于接触电源的接触区(22)之间的距离大于或等于在所述第二测量电极上的任何点和用于接触电源的接触区(22)之间的距离。
3.根据权利要求1所述的检验条，其中，所述第一测量电极包括多个第一指状物。
4.根据权利要求2所述的检验条，其中，所述第二测量电极包括多个第二指状物。
5.根据权利要求3所述的检验条，还包括布置在所述第一指状物上并且操作以在流体样本内产生指示要通过检验条测量的希望的流体性质的电位的试剂。
6.根据权利要求4所述的检验条，还包括布置在所述第二指状物上并且操作以在流体样本内产生指示要通过检验条测量的希望的流体性质的电位的试剂。
7.根据权利要求1所述的检验条，其中，在第一导电迹线上的该至少一个点为第一导电迹线与第一测量电极相交的点(1206)。
8.根据权利要求2所述的检验条，其中，在第二导电迹线上的该至少一个点为第二导电迹线与第二测量电极相交的点(1208)。
9.一种通过电源供电的电化学检验条，其包括
工作电极(814a)；和
操作地联结到工作电极的工作感测线(826)，所述工作感测线在点(1206)与工作电极相交，
其中，所述点(1206)和在检验条上的用于接触电源的接触区(22)之间的距离大于或等于在工作电极的部分上的任何点和接触区(22)之间的距离。
10.根据权利要求8所述的检验条，还包括：
反电极(216a)；和操作地联结到反电极的反感测线(224)；
所述反感测线在点(1208)与反电极相交，
其中，所述点(1208)和在检验条上的接触区(22)之间的距离大于或等于在反电极的部分上的任何点和接触区之间的距离。
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Also Published As
| Publication number | Publication date |
|---|---|
| CA2594417A1 (en) | 2006-07-20 |
| PL1846761T3 (pl) | 2017-12-29 |
| CN101103271A (zh) | 2008-01-09 |
| US20050284758A1 (en) | 2005-12-29 |
| JP2008527341A (ja) | 2008-07-24 |
| US7556723B2 (en) | 2009-07-07 |
| HK1115440A1 (zh) | 2008-11-28 |
| CA2594417C (en) | 2011-04-12 |
| ES2644041T3 (es) | 2017-11-27 |
| JP4827855B2 (ja) | 2011-11-30 |
| WO2006074927A1 (en) | 2006-07-20 |
| WO2006074927A8 (en) | 2007-08-23 |
| EP1846761A1 (en) | 2007-10-24 |
| EP1846761B1 (en) | 2017-07-19 |
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