CN1322299A - 玻璃器内少量分析物的探测器和方法 - Google Patents
玻璃器内少量分析物的探测器和方法Info
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- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
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Abstract
小型探测器及其制造方法,它使用象电量分析、电流分析和电位分析这样的技术检测在生物液体如血液或血清中的分析物浓度如葡萄糖或乳酸盐。探测器包括一个工作电极和一个反电极且可包括用于检测探测器在插头件中正确位置的插入监测线迹。在一个实施例中,探测器通过释放适量的电荷至样本中、检测放电所需要的时间、并使用放电量和时间量来检测用于电解部分分析物的电流,来确定分析物的浓度。
Description
本发明涉及用于探测在少量样本中的生物分析物的探测器以及制造和使用探测器的方法。
在化学和医学领域中,分析探测器有效地被用于确定生物分析物的存在和浓度。例如在紧急护理情况下,需要这些探测器监测糖尿病患者的葡萄糖和乳酸盐。
目前可使用的技术测量较大量的生物分析物样本,例如通常需要3微升或更多的血液或其它生物液。这些生物液样本是从患者处获得的如用针和注射器,或通过刺破部分皮肤如手指并挤压该处以获取可用样本量。这些过程对患者而言是不方便并且通常让人感觉疼痛,特别是需要频繁取样时。获取样本的不太疼痛的方法是众所周知的,例如刺破具有低浓度神经末梢的胳膊或大腿。然而,在优选部位刺入身体一般产生微量血液,因为这些部位没有大量近表皮毛细血管。
因此,研制出一个相对无痛的、易用的血液分析物探测器是理想且非常有用的,它能够进行少量分析物样本浓度的精确和敏感分析。
还需要研制出制造电化学探测器的方法,它能够减少因探测器和样本尺寸造成的误差。
本发明的探测器提供了一种用于微量分析物样本的检测和量化的方法。通常,本发明包括一种如通过电量分析、电流分析和/或电位分析来分析少量分析物样本的探测器和方法。本发明的探测器适用于利用不滤出或可扩散的氧化还原催化剂。探测器还包括一个用于保存与工作电极接触的样本的样本室。在许多情况下,探测器还包括一个不滤出或可扩散的第二电子转移介质。
在本发明的优选实施例中,工作电极面向反电极,在样本室内的两电极之间形成一个测量区,该测量区的大小被设计成能获取不超过约1微升的样本,优选地不超过大约0.5微升,更好地是不超过大约0.32微升,最好不超过0.25微升,最佳地不超过大约0.1微升。
在本发明的一个实施例中,设计成被插入电子仪表中的探测器配备了工作电极、反电极和如果探测器被正确地插入仪表中而提供了与电子仪表的电接触的导电的插入监测器。当探测器被正确插入电插头件时,导电的插入监测器被设计布置在电路附近。
在本发明的另一个实施例中,探测器装配有多个触点,每个触点具有一个触片,该触片用于连接电子仪表。多个触点和触片位于长宽形基层上,每个触片具有平行于基层宽度的触片宽度。触片宽度总和大于基层宽度。在优选的实施例中,在探测器上,六个电插头件形成有六个触片,但其宽度接近四个触片的宽度。例如,一个工作电极、三个反电极(如一个反电极和两个指示电极)和两个分别有一触片的插入量插头件;在工作电极和三个反电极触片的同等宽度内,可以使这六个触片分别连接。
本发明还包括一个用于在探测器和电子仪表或其它装置之间提供电气接触的电插头件。电插头件具有多个接触结构,每个结构具有一个用于电连接探测器触点的近接触端和用于电连接电设备的远端。在本发明的一个实施例中,多个第一触点纵向延伸平行于从末端到最近端。另外,一个或多个第二触点纵向延伸紧邻第一触点,从末端通过第一接触结构的最近端并以一定角度朝向接触结构的纵向中心线。探测器则通过最近接触端产生接触。
电插头件更适用于至少具有2个纵向延伸通过第一接触结构的最近端并以一定角度朝向接触结构的纵向中心线的第二接触结构。在成角度或倾向部分后,一个实施例中的第二接触结构的最近接触端与探测器的唯一导电面例如导电插入监测器形成电气接触。另一方面,第一接触结构可以被配置和安放于接触一个或多个探测器的工作和/或方向电极,第二接触结构被配置和安放于接触一个或多个导电插入监测器。
本发明的探测器可被配置成侧面放置或顶端放置。另外,在一些实施例中,探测器可以是整个获取样本和分析物测量装置的一部分。为了装置可用于刺破用户的皮肤以产生液体样本,例如血液,然后通过探测器收集整个获取样本和分析物测量装置可以包括探测器和皮肤刺破装置。至少在一些实施例中,不用移动整个获取样本和分析物测量装置即可收集液体样本。
在一个实施例中,探测器与一电设备相连以提供一个连接到探测器的处理器。在样本室内的样本的电解期间,该处理器被安装并用于测定一系列电流值。处理器从系列数值中测定电流峰值。在电流值减少至低于电流峰值的极限分数后,斜率数值从电流值中被测定出来并显示整个周期的电流值的对数关系。处理器从数值斜率中测定一个推断斜率。从推断斜率和所测电流值中,处理器测定出大量需要分析的样本的电荷并从该电荷中分析出样本分析物的浓度。
构成探测器的方法之一如上所述,包括在第一基层上形成至少一个工作电极和在第二基层上形成至少一个反向或反/参考电极。在第一或第二基层上放置间隔层。当探测器制成时,间隔层决定了用于提取和保存样本的室。当探测器制成时,氧化还原催化剂与/或第二电子转移介质可被置于样本室内设置区域的第一或第二基层上。然后第一和第二基层一起被产生并通过间隔层间隔,该间隔层具有可以进入至少一个工作电极和至少一个反向或反/参考电极的样本室。在一些实施例中,第一和第二基层是单一薄片或连续网状材料的一部分。本发明包括特别有效和可靠的探测器的制造方法。
如此有效和可靠的方法包括具有用第一和第二释放衬垫部覆盖的第一和第二粘贴面,然后通过第一释放衬垫逐条切割并粘贴但不通过第二释放衬垫部。这些切割形成一个或多个样本室区。部分第一释放衬垫被移动以放置第一粘贴面,在样本室区之上该粘贴面放置第一释放衬垫的剩余部分。如此放置第一粘贴面适用于具有在其上放置一个或多个导电线迹的第一基层。为了放置第二粘贴面,第二释放衬垫部被移到与粘合剂和样本室区的第一释放衬垫一起。然后第二粘贴面适用于在其上具有一个或多个导电线迹的第二基层。此方法形成了具有相对于样本室区之一的样本室。
这些和表现本发明特点的不同其它特点在附件声明中特别指出。为了更好地理解本发明,从以下结合附图所做的详细描述中,人们将了解到本发明的优点和从使用者得到的目的。
现在参考附图,其中在几个视图中,相同参考数字和字符表示相应的结构:
图1是具有工作电极和相反的反电极和样本室的本发明电化学探测器的第一实施例的示意图;
图2是图1所示探测器的分解视图,单独画出了各层;
图3是具有工作电极和相反的反电极和样本室的且根据本发明原理的电化学探测器的第二实施例的示意图;
图4是根据本发明原理的电化学探测器的第三实施例的俯视图,该探测器包括多个工作电极;
图5A表示具有一个用于本发明探测器第四实施例的工作电极的第一基层的俯视图;
图5B表示其中反电极位于图5A的基层之上和对面的第二基层(图5A的反面)的俯视图;
图5C表示在图5A中位于第一基层和图5B中的第二基层之间的间隔层的俯视图;
图6A表示具有一个用于本发明探测器第五实施例的工作电极的第一薄膜的俯视图;
图6B表示位于图6A中的第一薄膜之上的间隔层的俯视图;
图6C表示具有位于图6B的间隔层和图6A的第一薄膜之上的反电极的第二薄膜的仰视图;
图7A表示根据本发明的具有一个用于探测器第六实施例的工作电极的第一薄膜的俯视图;
图7B表示位于图7A中的第一薄膜之上的间隔层的俯视图;
图7C表示具有位于图7B的间隔层和图7A的第一薄膜之上的反电极的第二薄膜(图7A和7B的反面)的仰视图;
图8A表示具有一个用于本发明探测器第七实施例的工作电极的第一薄膜的俯视图;
图8B表示位于图8A中的第一薄膜之上的间隔层的俯视图;
图8C表示具有位于图8B的间隔层和图8A的第一薄膜之上的反电极的第二薄膜(图8A和8B的反面)的仰视图;
图9A表示具有一个用于本发明探测器第八实施例的工作电极的第一薄膜的俯视图;
图9B表示位于图9A中的第一薄膜之上的间隔层的俯视图;
图9C表示具有位于图9B的间隔层和图9A的第一薄膜之上的反电极的第二薄膜(图9A和9B的反面)的仰视图;
图10A表示具有一个用于本发明探测器第九实施例的工作电极的第一薄膜的俯视图;
图10B表示位于图10A中的第一薄膜之上的间隔层的俯视图;
图10C表示具有位于图10B的间隔层和图10A的第一薄膜之上的反电极的第二薄膜(图10A和10B的反面)的仰视图;
图11A表示具有一个用于本发明探测器第十实施例的工作电极的第一薄膜的俯视图;
图11B表示位于图111A中的第一薄膜之上的间隔层的俯视图;
图11C表示具有位于图11B的间隔层和图11A的第一薄膜之上的反电极的第二薄膜(图11A和11B的反面)的仰视图;
图12A表示具有一个用于本发明探测器第十一实施例的工作电极的第一薄膜的俯视图;
图12B表示位于图12A中的第一薄膜之上的间隔层的俯视图;
图12C表示具有位于图12B的间隔层和图12A的第一薄膜之上的反电极的第二薄膜(图12A和12B的反面)的仰视图;
图13A表示本发明探测器器件薄片的一个实施例的俯视图;
图13B表示本发明探测器器件薄片的另一实施例的俯视图;
图14A至14F表示在间隔层内设置样本室的连续过程的横截面图;
图14G是图14B的仰视图;
图15A是用于计算整个时间内的分析物浓度的电流图表;
图15B是用于计算整个时间内的分析物浓度的曲线图;
图16A是根据本发明用于在电插头件装置内插入定位的探测器的俯视透视图;
图16B是图16A中电插头件装置的探视图;
图17A是图16A中电插头件装置内完全插入定位的探测器的俯视透视图;
图17B是图17A中电插头件装置的俯视图;
图18A是图16A和图16B中电插头件装置的仰视透视图;
图18B是图17A和图17B中电插头件装置的仰视透视图;
图19A至19L表示在触片之间适用导电路径的例子;
图20表示从插头件内侧看设置在插头件中本发明探测器的横截面图;
图21表示与柳叶刀具一起使用的环的透视图。
如本文所用,以下定义限定了上述术语。
“空气氧化型介质”是空气氧化型氧化还原催化剂,从而最好至少90%的介质在氧化状态下以固体或液体形式存放于空气中达一段时间如一个月或更短,最好是一周或更短,最佳地是一天或更短。
“电流分析”包括静态电流分析、时间电流分析和Cottrell型测量法。
“生物液”是任何可测量其中分析物的体液,例如血液(包括整个血液和其无细胞成分如血浆和血清)、间隙液、真皮液、汗、泪、尿和唾液。
“电量分析”是检测在完成或接近完成电解分析期间通过或射出的电荷,即直接在电极上的或通过一个或多个导电介质。电荷是通过电荷在部分或接近完成电量分析期间所通过的电荷测量被检测的,或通常是通过多次测量衰减电流和消逝期的电量被检测的。由于电解种类造成的电解浓度的下降导致衰减电流。
“反电极”涉及一个或多个与工作电极成对的电极,大小等于流过工作电极但符号与之相反的电流经过反电极。“反电极”包括也起参考电极作用(例如,反/参考电极)的反电极,除非说明书表示“反电极”不包括参考电极或反/参考电极。
“有效扩散系数”是表现物质例如分析物、酶、或氧化还原催化剂在电化学电池的电极间的体积内传输的扩散系数。至少在一些情况下,空腔体积可被至少一种媒介(如样液和聚合物膜)占用。物质通过每种媒介的扩散可以不同的机率发生。有效扩散系数相应于通过此多介质体积的扩散机率并通常不同于在只注入样液的空腔中物质扩散系数。
“电化学探测器”是装配了通过电化学氧化还原作用来检测的是否存在分析物和/或测量分析物浓度的装置。这些氧化还原作用被转换成相应于分析物数量或浓度的电信号。
“电解”是直接在电极上电极或通过一个或多个导电介质的化合物的电镀氧化或电镀还原(例如,氧化还原催化剂和/或酶)。
“面对电极”是工作电极与反电极的状态,其中工作电极的工作表面大致位于反电极表面的对面。至少在一些情况下,工作电极和反电极之间的距离小于工作电极工作面的宽度。
当化合物被截留或化学附着于表面上时,化合物在表面上是“固定不动的”。
“指示电极”是一个检测样本室和/或测量区域的部分或全部注入情况的电极。
“层”是指一层或多层。
“测量区域”在此被定义为获取在分析物化验期间被查询的部分样本的样本室尺寸的地方。
“非可扩散性”、“不滤出”或“非释放的”化合物是用于分析物化验期间基本上不从工作电极的工作面扩散的化合物。
当电池溶液为0.1M氯化钠溶液为pH7时,“反/参考电极的电压”是电池的参考电极或反/参考电极的半电池电压。
“氧化还原催化剂”是用于在分析物和工作电极之间直接或通过第二电子转移介质导电的导电介质。
“参考电极”包括也作为反电极(例如,反/参考电极)的参考电极,除非描述提供“反电极”不包括参考或反/参考电极。
“第二电子转移介质”是在氧化还原催化剂和分析物之间导电的分子。
“样本室表面”是工作电极、反电极、反/参考电极、参考电极、指示电极、间隔层或样本室的任何其它接合面的表面。
“工作电极”是使用或不使用氧化还原催化剂进行电解氧化或电解还原分析物的电极。
“工作面”是用不滤出氧化还原催化剂覆盖并显露样本的部分工作电极,或,如果氧化还原催化剂是扩散的,“工作面”是接受样本的工作电极部分。
本发明的在玻璃器内的少量分析物的探测器被设计用于测量体积不超过约1微升的部分样本的分析物浓度,体积优选地不超过约0.5微升,体积更好地不超过约0.32微升,体积最好不超过约0.25微升,体积最佳地不超过约0.1微升。
分析物的重要性在于提供溶液或生物液,例如血液或血清。
大致参见附图,特别是见图1、2,本发明的在玻璃器内的少量分析物的探测器20通常包括在第一基层32上的工作电极22、在第二基层34上的反(或反/参考)电极24和样本室26。为了当样本进入样本室时,样本与可能出现的工作电极22、反电极24和任何参考电极或指示电极电接触,样本室26如此设置。这将允许电流在电极之间流动以产生分析物的电解(电解氧化或电解还原)。间隔层33位于第一基层32和第二基层34之间以便在电极22、24之间产生间隙并提供在其中装有要测定样本的样本室26。
工作电极
工作电极22可能是碳纤维合成物模压而成的或可能包括适当导电层沉积于其上的惰性非导电基材如聚脂。通常,导电层相应地具有低电阻并且在工作期间在探测器电压范围内处于电化学惰性状态。适用导电层包括黄金、碳、白金、二氧化钌、钯、导电的环氧,例如ECCOCOAT CT5079-3碳注导电环氧镀层(来自W.R.Grace公司,Woburn,MA),以及其它本领域技术人员公知的非腐蚀材料。电极(例如导电层)通过例如汽相沉积和印刷镀覆于惰性材料表面上。最好,电极适用于被印刷于基材上。
惰性非导电基材也指基层、底层或类似的材料。通常此基材是不导电材料,例如任何绝缘材料,即不能传输电荷或电流。适用于本发明的探测器的基材材料的使用案例包括聚酯、聚乙烯(高密度和低密度)、聚对苯二甲酸乙二酯、聚碳酸酯、乙烯基或类似的物质。基材可与底层涂料或其它这样的镀层一起被处理以改善其上电极的附着。接头23′设置在工作电极端部上以便简单地使电极于外部电极(未显示)如电压源或电流测量装置相连。连接至工作电极22上的触片23如工作电极延伸部可以位于接头23′上。
当使用不可滤催化剂时,为了防止在没有涂敷催化剂的工作电极部分上产生电化学反应,绝缘体或其它绝缘材料可被置于电极之上、之下或永氧化还原催化剂围绕该区域。可用绝缘材料包括蜡和不导电的有机聚合物如聚乙烯。氧化还原催化剂的覆盖部分将不接触样本且因此将不成为电极工作面的一部分。
传感化学
除工作电极22之外,传感化学材料供应于样本室26用于分析物的分析。此传感化学适用于包括氧化还原催化剂和第二导电催化剂,尽管在一些实施例中,一个或其它被单独使用。氧化还原催化剂和第二导电剂可被分别可扩散或不滤出(例如非可扩散)以便单独或一同被可扩散或不滤出。探测器化学部件的放置依赖于它们是否可扩散或不滤出。例如,不滤出与/或可扩散部件通常形成于工作电极上的传感层。可选地,一个或多个可扩散部件可被置于样本引入之前的样本室的任意表面。作为另一个例子,一个或多个可扩散部件在样本被引入探测器之前被注入样本中。
如果氧化还原催化剂是不滤出的,则非可扩散氧化还原催化剂通常作为传感层置于工作电极22上。在一具有氧化还原催化剂和第二导电剂的实施例中,如果氧化还原催化剂和第二导电剂都是不滤出的,则不滤出部件都作为传感层置于工作电极22上。
例如,如果第二导电剂是可扩散且氧化还原催化剂是不滤出的,则至少氧化还原催化剂作为传感层置于工作电极22上。可扩散的第二导电剂不需要置于工作电极的传感层上,但是可置于氧化还原催化剂探测层所含的样本室的任意表面,或可被置于样本内。如果氧化还原催化剂和第二导电剂都是可扩散的,则可扩散部件可独立或联合置于样本室的任意表面和/或置于样本内(例如,每个可扩散部件不需要置于样本室的任意表面或置于样本内)。
不论氧化还原催化剂是可扩散或不滤出的,其在工作电极22和分析物之间催化电流并可进行可能不适用于在电极上直接电化学反应的分子的电化学分析。催化剂作为导电剂作用于电极和分析物之间。
可查询的分析物包括如葡萄糖、乙酰胆碱、淀粉酶、胆红素、胆固醇、绒毛膜促性腺激素、肌氨酸致活酶(例如,CK-MB)、肌氨酸、脱氧核糖核酸、果糖胺、葡萄糖、谷氨酰胺、增长荷尔蒙、荷尔蒙、酮、乳酸盐、过氧化物、前列腺类抗原、凝血素、RNA、甲状腺刺激荷尔蒙和肌钙蛋白。分析物的浓度例如麻醉药或药物,如,例如,抗生素(例如,庆大霉素、万古霉素和其它类似的物质)、毛地黄毒苷、异羟洋地黄毒苷、滥用药物、茶碱和杀鼠灵均可被检测。适用于检测DNA和/或RNA浓度的化验公布于美国专利申请序列号09/138,888和09/145,776并详细描述于国际申请PCT/US99/14460。
氧化还原催化剂
尽管任何有机的或有机金属的氧化还原类可被用于作为氧化还原催化剂,适用于氧化还原催化剂的一类是过渡金属化合物或合成物。适用于过渡金属化合物或合成物的样例包括锇、钌、铁和钴化合物或合成物。在这些合成物中,过渡金属同等地一定要一个或多个配位体。配位体通常是一、二、三或四配位基。最优选的配位体是杂环氮化合物,例如多吡啶和/或咪唑衍生物。多配位基配位体包括多吡啶和/或咪唑环。或者,可以使用二茂金属络合物衍生物如二茂铁。催化剂样例之一是[Os(4-(N-(6-氨基肽酶)氨基双吡啶)(1,1′-二甲基-2,2′-双咪唑)2]CL3。
氧化还原催化剂可以是可扩散的氧化还原催化剂或不滤出的氧化还原催化剂,例如不滤出氧化还原聚合物。氧化还原催化剂的附加信息看例如,美国专利应用序列号09/295,962,公布于1999年4月21日和PCT公布的应用WO98/35225。
第二导电剂
在本发明的优选实施例中,探测器包括氧化还原催化剂和能够在氧化还原催化剂和分析物之间导电的第二导电剂。第二导电剂可以是可扩散的或不滤出的(例如,夹杂入或通过等位、共价、离子而连接于氧化还原聚合物)。适用于第二导电剂的样例之一是催化分析物反应的酶。例如,当分析物是葡萄糖时,葡萄糖氧化酶或葡萄糖脱氢酶如吡咯并喹啉醌葡萄糖脱氢酶(PQQ)被使用。当分析物是乳酸盐时,乳酸盐氧化酶扮演催化角色。其它分析物使用其它酶。
反电极
如图1和2图解,反电极24以类似于工作电极22的方式构建。反电极24还可以是反/参考电极。可选地,单独的参考电极可提供与样本室的接触。用于反/参考电极或参考电极的适用材料包括如印刷于不导电基材上的银/氯化银或银/溴化银或银质基材上的银氯化物。用于构建工作电极22的可行性的同样材料和方法可用于制作反电极,然而不同的材料和方法也可被使用。其上装有触片25的接头25′可方便地提供与外部电子装置(未显示)如电量计、稳压器或其它测量设备连接。
不导电注入材料可选地如不导电墨水可形成邻近反电极,或在多个反电极之间以提供沿样本室内样本液体的移动路径的平面。不导电注入材料适用于通过毛细管运动与/或通过降低在靠近反电极处气泡成为陷阱的可能性创建促进样本室注入的光滑面。此不导电材料可是彩色或无色的且可通过印刷或其它技术成型于基层上。不导电材料可提前或在反电极成型后放置。在某个实施例中,不导电墨水被用于注入多个12.3微米(0.5密耳)厚的反电极之间的地方。在另一实施例中,不导电墨水被用于注入多个6.4微米(0.25密耳)厚的反电极之间的地方。通常,无填充物墨水必须用于厚度小于6.4微米的情况,并且在一些探测器设计中,无填充物墨水必须用于6.4微米厚的反电极。
电极设置
在本发明的某一实施例中,工作电极22和反电极24置于对立的且相互面对以相成面对的电极对如图1和2中描述。在优选配置中,样本室26通常置于两电极之间。因为这种面对的电极放置,电极通过一个不超过大约0.2毫米(例如,至少一部分工作电极通过不超过200微米的距离与一部分反电极隔离)的距离被隔开,更适用于不超过100微米,且最适用于不超过50微米。
电极不需要直接相互对立;它们可能是轻微地相互偏移。进一步而言,两电极不需要相同的尺寸。工作电极22适宜地延伸探测器20的宽度且反电极24是该宽度的一部分或全部。工作电极22或反电极24可包括多个电极,如图4(如反电极324,344)和图5B(如反电极424,442,442)所示。反电极24也可以是梳状的齿。反电极和工作电极的其它所有放置都在发明范围内。然而,用于特定实施例,至少一部分工作电极与反电极的某部分的隔离距离更适宜不超过上述指定限制。
在本发明的另一实施例中,工作和反电极是共面的。在此例中,样本室与两电极接触并通过不导电惰性基层或底层在电极的对立面上联合。用于惰性基层的适用材料包括不导电材料如聚酯。
本发明探测器的另一种放置也是可行的。例如,两电极可置于表面并相互成一定角度。此放置的一种可能是电极在表面上形成右角。此放置的另一种可能是电极在曲面上如管子内部。例如,可以如此放置工作和反电极使得工作和反电极从管子的对立面相互面对。这是面对电极对的另一个例子。可选地,电极在管壁上(例如,串行排列或并排)相互靠近放置。在任何配置中,为了两电极不直接相互电接触,两电极必需如此放置以防止电化学探测器短路。
再次参见图l和2,由于电极延伸称作“线迹”,电极22、24从样本室26延伸至探测器20的另一端。每个线迹提供触片23、25用于电连接至表或其它设备以允许用于数据和测量收集,稍后将详细描述。每个触片23、25被安置在接头23′、25′上。在实施例一中,表上安置有不只一个触片。在实施例二中,唯一的触片被用于连接至一个或多个电极;即,多个电极两个一起并通过一个触片连接。
当电极如图1和2中描绘的相互面对时,间隔层33可用于保持电极隔离;可在图2中清楚地看见间隔层33。间隔通常由惰性不导电材料构成如压感粘合剂、聚酯、MylarTM、KevlarTM或任何其它强壮、聚合物薄片,或,可选地,聚合物薄片例如由于其化学惰性而选择TeflonTM片。除了防止电极之间的接触,间隔层33可作用于样本室26的边界部分。其它间隔包括粘合层和双面粘合带(例如,在片对立面上使用粘合剂的载片)。粘合剂例如通过镀层可被用于聚合物上以提供间隔层33。
样本室
样本室26通常是通过电极22、24,基层32、34和间隔层33如图1和2所示被联合定义。在分析物化验期间,测量区域被包含在此样本室内且是仅包含被查询样本部分的样本室。在图1和图2所示的本发明的实施例中,样本室26是两电极22、24和其通过间隔层33联合的不导电基层32、34之间的空间。在此实施例中,样本室具有一个适宜不超过大约1微升,更适宜不超过大约0.32微升,且也更适宜不超过大约0.25微升的体积。
在图1、2所述的本发明实施例中,测量区具有相当于样本室体积的体积。在优选实施例中,测量区占样本室的80%,在一个更优选的实施例中,它占90%,在最佳实施例中,它占100%。
在本发明的另一个实施例中,如图3所示,探测器220具有一不导电基层232上的工作电极222,一在不导电基层234上的反电极224,和它们之间的间隔233。一触片223从工作电极222延伸,同样地,一触片225从反电极224延伸。样本室226(通过基层232、234和间隔233定义)延伸了探测器220的长度并包括比最近电极222、224区更多的空间。在此实施例中,相应于包括将被查询样本部分的区域,测量区是通过工作电极222和反电极224的工作面联合的样本室226的一部分。在此实施例中,测量区具有适宜样本体积不超过大约1微升、更适宜不超过大约0.32微升、也更适宜不超过大约0.25微升、最适宜不超过大约0.1微升的体积。
在上述讨论的所有实施例中,样本室和测量区的厚度通常对应于间隔层33、233(例如图2、3中电极之间的距离,或在电极和在电极是同平面的实施例中的惰性底层之间的距离)的厚度。例如,间隔可以是粘合剂或双面粘合带或片。粘合剂的使用样例包括氨基甲酸乙酯、丙烯酸盐、丙烯酸类聚合物、胶乳、橡胶和其它已知粘性材料。由于更多样本将通过所提供的样本体积与电极面接触,此厚度适宜薄以促进分析物的快速电解。此外,一个厚样本室有助于减少在分析物化验期间来自于样本室的其它部分的从分析物扩散到测量区的错误,因为相对于测量时间扩散时间长。通常,样本室的厚度在大约50微米-200微米之间。
吸附剂
样本室在样本被注入样本室前可能是空的,或者在某些情况下,样本室可包括吸附剂材料(如图3中所示吸附剂50)以吸附并保留测量过程中的样本液体。吸附剂适用材料包括聚酯、尼龙、纤维素和纤维素衍生物例如硝化纤维。吸附剂材料通过可完成的灯心作用或适宜地替换样本室的毛细作用促进少量样本的吸收。除了或可选地一部分或全部样本室壁可通过用于降低样本液体的表面张力并提高样本室内液体的流动的表面活性剂被镀层。可用表面活性剂的例子可以以德国惠灵顿杜邦的商品“Zonyl FSO”买到。
其它不同于吸附剂的灯心作用的方法可用于传送样本到样本室或测量区。用于这样传送的样例包括在样本上施加压力以推动其到样本室,在样本室内通过泵或其它产生真空的方法制造真空以拉拽样本到样本室,由于作用于厚样本室壁的样本界面张力的毛细血管作用,以及吸附剂材料灯心作用。
整个探测器的装配保持紧密结合以确保样本保持与电极的接触和样本室与测量区保持同样的体积。在样本的电量分析中,所定义的样本体积的测量法是必需的,这是一个重要的需要考虑的问题。
替换型探测器设计方案
图4至图23表示可选的上注和侧注的探测器排列。参见图4,探测器320具有工作电极322、反电极324、第二反电极344(具有注入指示器功能,如下面描述)、延伸长度至少为部分探测器320长度的样本室326和可选地包括吸附剂350。
图5A至图5C表示装配探测器时的优选实施例的3个层。图5A具有基层432上的工作电极422。工作电极422具有从样本室延伸至表423′上触片423的线迹453;触片423连接探测器至一表或其它测量设备。图5B(图5A翻转使显示电极面朝上)具有在基层434上的反电极424,且还包括第一电极441和第二指示电极442。反电极424具有终止于分别于表425′上触片425、443、444的线迹454。当两基层432、434成对立面且相互面对时,图5C中的间隔433决定了样本室426并位于电极之间的空间。
图6A至图6C也表示被装配成探测器时的3个层。在图6A中,工作电极502形成于第一基层500上。工作电极502包括一用于连接外部电子装置的触片503;此触片503通过线迹552连至工作电极502。间隔层504如图6B中所示例如粘合剂或双面带层决定了通道506以产生用于探测器的样本室。两反电极(或反/参考电极)510、512形成于第二基层508上,如图6C中所示(图6A翻转使电极面朝上)。此种多个反电极的排列用反电极512如下描述可提供注入指示器功能。每个反电极510、512具有用于与外部电子装置连接的接触区域或触片511、513;这些触片511、513通过线迹551、553连至反电极510、512。为了工作电极502和两反电极510、512在通道506的区域内相互面对,第二基层508被翻转置于第一基层500之上,它们之间有间隔层504。
在一些情况下,反电极510靠近通道506的入口处514在至少大于其它反电极512两倍且可能至少5或10倍的样本室内有一表面区域。如上所述地不可滤或不可扩散的氧化还原催化剂与/或第二导电剂可以在一个对应于通道506的区域内设置在第一基层500或第二基层508上。
工作电极和反电极可被制成以覆盖整个通道区域(除两反电极之间的小空间之外)。在此实施例中,样本室和测量区最终是相同的并有同样的体积。在另一实施例中,测量区是例如样本室体积的80%或90%。我们可以理解类似的探测器可被制成用于一个反电极或3个或更多个反电极。我们还可以理解多个工作电极可位于探测器上。
图7A、7B和7C表示侧注探测器结构。图7A表示具有工作电极522的第一基层520。图7B图示决定了通道526的间隔524。图7C(图7A和7B的翻转图)说明了具有3个反向(或反/参考)电极530、532和534的第二基层528。这种多个反电极的排列可提供注入指示器功能,如下面描述。缺口536、538或凹进的或锯齿状的部分可形成于通道526的每个起始边缘以促进将液体拉拽至探测器内。这种装置可利于以灯心或毛细血管方式注入通道(例如,样本室)。这种装置还可降低在样本收集期间通过用户不注意地把刀口朝前背对皮肤地按压探测器顶端而阻塞通道的可能性。
图8A、8B和8C说明了侧注探测器结构的另一个例子。图8A表示具有工作电极542的第一基层540。图8B表示决定了通道546的间隔544。图8C(图8A和8B的翻转图)表示具有3个反向(或反/参考)电极550、552和554的第二基层548。
图9A、9B和9C说明了上注探测器排列的另一例子。图9A表示具有工作电极562的第一基层560。图9B图示决定了通道566的间隔564。图9C(图9A和9B的翻转图)表示具有2个反(或反/参考)电极570和572的第二基层568。这种多个反电极的排列可提供注入指示器功能,如下面描述。排出口574(如图9C中阴影部分所示)经由第二基层放置。在本图示的实施例中,此排出口574通过唯一的携带反电极和可选地间隔564的基层568形成的。在此实施例中,排出口可通过例如冲模切割部分基层形成。此冲模切割至少可移去部分反电极,但是足够量的反电极可被保留用于接触通道内的样本和电通至接触探测器的另一终端。在另一实施例中,排出口574可通过所有层或通过第一层而不是第二层形成。
在图10A、10B和10C中图示的另一实施例具有不同的阴影。探测器包括具有至少一个工作电极580的第一基层579,如图10A所示。探测器还包括具有在间隔581内形成的通道582的间隔581,如图10B所示。探测器进一步包括具有2个反电极584、585的第二基层583,如图10C(图10A和10B的翻转图)所示。排出孔586通常被切割过所有层并从探测器的一侧延伸。在一些实施例中,排出孔和探测器的前面部分587在排出孔和探测器的前面部分用可重复的距离被同时切割以提供用于通道582和工作电极580的可重复长度。这种上注探测器排列可选择地包括可位于通道582注入起始端的缺口588或凹进的或锯齿状部分以利于将液体拉拽到探测器中。
图11A、11B和11C表示侧注探测器排列的另一例子。图11A表示具有1个工作电极642的第一基层640。图11B图示决定了通道646的间隔644。图11C(图11A和11B的翻转图)表示具有3个反向(或反/参考)电极650、652和654的第二基层648。这种多个反电极的排列可提供注入指示器功能,如下面描述。通道646的长度通常是通过2个沿探测器侧面656、658并行切割被决定的。
由于侧面笔直的原因,可以并列生产这些探测器(和那些图1、2、5中的探测器),如图13A中所示。这样的定位可在生产过程中减少材料的浪费。临近探测器生产过程的另一可选处理优点是氧化还原催化剂和/或第二导电剂可通过分解沿临近探测器的行或列的这些部件的持续液体被容易地定位于通道内。与其它技术如单独地在独立通道内放置这些部件相比,这可能导致更好的效果和减少浪费昂贵的试剂如氧化还原催化剂和/或第二导电剂。
图12A、12B和12C表示探测器的另一种配置。此探测器包括具有至少1个工作电极602的第一基层600,如图12A中所示。探测器还包括在间隔604内形成的通道606的间隔604,如图12B中所示。探测器进一步包括具有2个反电极610和614的第二基层608,如图12C中(图12A和12B的翻转图)所示。这种多个反电极的排列可提供注入指示器功能,如下面描述。探测器还可包括,例如指示器,如槽614或从指示用户探测器应该放置临近样本的面延伸部分616。表面印刷还可或可选地作为指示器应用于探测器。当样本来自特定面,在探测器读取是唯一正确的地方时,一些指示器装置是特别重要的。
多电极探测器和其校准
多电极探测器可用于各种原因。例如,多电极可用于测试使用单一样本的多种分析物。使用多电极的实施例一具有一个或多个样本室,每个样本室包括一个或多个用工作电极定义不同测量区的工作电极。如果氧化还原催化剂是不滤出的,一个或多个工作电极可有适当的化学试剂,例如,适当的酶,以测试第一分析物且一个或多个保留工作电极可有适当的化学试剂以测试第二分析物等等。例如,多电极探测器可包括一个具有位于其上的葡萄糖氧化酶的工作电极以检测葡萄糖浓度且另一工作电极可具有位于其上的乳酸盐氧化酶的工作电极以检测乳酸盐浓度。
多电极还可用于提高最终读数的精度。来自每个工作电极(检测同一分析物的所有电极)的测量可被平均或另外联合在一起以获取一个更精确的或可靠的读数。在一些实例中,如果数值和平均值之间的不同造成极限限制,测量可被丢弃。此极限限制可能是,例如,基于统计参数如背离标准的平均测量的检测。当遗漏被丢弃数值时,平均值则可能被重新计算。除了使用多电极探测器来增加精度,多次测量可在每个电极进行并加权平均以增加精度。该技术还可被用于单电极探测器以增加精度。
可用于精确检测电极对测量区体积并也可用于降低噪音的多电极探测器的用例在此提出。在此用例中,工作电极之一配备了不滤出氧化还原催化剂和不滤出第二导电剂(例如酶)。另一工作电极包括不滤出氧化还原催化剂,但在电极上没有第二导电剂。一个可选的第三工作电极联合在电极上的氧化还原催化剂和第二导电剂。虽然可扩散部件不被限制置于工作电极上,相似的装置可被构成使用可扩散氧化还原催化剂和/或可扩散第二导电剂。工作电极之间的距离更适宜氧化还原催化剂和/或酶在测量期内(例如在同一样本从引入到最终测量的样本室的时间期内)电极之间不充分地扩散是足够的。
由在注入样本前处于非均匀氧化状态的氧化还原剂造成的探测器错误可以通过同时在靠近工作电极和反电极的区域内电解样品来测量。在第一工作电极上,分析物经电解而产生了样本信号。在第二工作电极上,由于缺少第二导电剂(假定第二导电剂是必需的),分析物不被电解。然而,由于在引入样本和/或工作电极和反电极之间的可扩散氧化还原催化剂的穿梭往返之前的处于混合氧化阶段(例如,一些氧化还原被置于还原阶段中和一些氧化还原被置于氧化阶段中)的氧化还原催化剂的电解,可以从利用第一电极对而经过电荷中提取利用第二工作电极经过的小电荷,以便基本上消除由氧化还原剂的氧化装置带来的误差和/或消除由扩散形氧化还原剂造成的背景电流。此过程还减少相关的其它电解干扰错误,如抗坏血酸盐、尿酸盐和醋氨酚以及与电容性充电和感应电流相关的错误。
样本室的厚度可通过测量在电极和其相应的反电极之间的适宜缺少所有液体的容量被检测。电极对依赖于电极的表面、极间间隔和金属板之间的非传导性的连续材料。非传导性的连续空气一致的,即通常意味着此电极装置的容量是几个皮可法拉(或大约100-1000皮可法拉,如果在电极和反电极之间提供液体用于非传导性的连续最生物学的液体是接近75)。因此,由于电极表面已知,电极对的容量的测量通过检测测量区厚度允许在大约1-5%内。
其它电极装置还可使用这些技术(例如,在缺少关键部件情况下的容量测量和电量分析测量)以降低背景噪音和由于干扰和被查询样本体积的不精确知识造成的错误。涉及一个或多个工作电极和反电极和一个或多个上述测量法的草案可逐步展开且均在本发明范围之内。例如,单电极对被需要用于容量测量,但是,附加电极可被用于便利。
注入指示器
当使用被注入1微升或更少液体的样本室时,当样本室被注入时,通常需要能够检测。图6A至6C表示具有注入指示器构件的探测器。图6A特别表示印刷于工作电极502之上的第一基层500。间隔层504(图6B),例如,例如,粘合剂层或双面带,形成于第一基层500和具有形成于层内的通道506的工作电极之上以提供样本室。第二基层508印刷于两反电极510、512,如图6C中所示(图6A和6B的翻转图以显示电极朝上)。靠近通道506入口514的反电极510具有在适宜至少2倍大于且更适宜至少5倍或10倍大于其它反电极512的样本室内的表面积。
当探测器注入液体时,通过观察第二反电极512和工作电极502之间的信号,探测器可被指示为注入或充分注入。当液体达到第二反电极512时,来自该反电极的信号将变化。相应用语观察的信号包括,例如,电压、电流、电阻、阻抗或第二反电极512和工作电极502之间的容量。如果信号值(例如,电压、电流、电阻、阻抗或容量)达到样本室被注入的指示,可选择探测器在注入后被观察以检测。
在可选实施例中,反电极或工作电极可被分成2个或多个部分和多个来自各自部分的用于检测探测器是否被注入的观察信号。在一样例中,工作电极面对反电极和指示电极。在另一样例中,反电极、工作电极和指示电极不是面对的,但是例如并排的。通常,指示电极位于从样本入口处到工作电极和反电极的更下游。
用于侧注探测器的如图5、7、8和11中所示的那些指示电极可置于主要反电极的每个面。这允许用户可从具有置于更上游的指示电极的左侧或右侧注入样本室。此3电极装置不是必需的。侧注探测器还可具有一独立指示电极且更适宜指示哪个面应该置于与样本液体联系。
两个指示电极可选择地或另外附加地用于结合反/参考电极检测何时样本室开始注入和何时注入样本室以防止样本室的部分注入。两指示电极可选择地保持在不同于反/参考电极的电压。样本室注入的起始和完成是通过指示器和反/参考电极之间的电流的流动指示的。
在另一实例中,每个反/参考电极的电压可以是相同的。当所有3个反/参考电极的电压是相同时,如等于0电压,则当测量区开始注入时,液体允许电流在工作电极和第一反/参考电极之间流动,由于使用酶和催化剂的分析物的反应产生了在第一反/参考电极上的电流。当液体达到第三反/参考电极时,另一电流类似于第一反/参考电极可被测量以指示测量区已满。当测量区满时,3个反/参考电极可选地一起不足或其信号可被叠加或另外联合。
指示电极还可用于提高分析物测量的精度。指示电极可作为工作电极或反电极或反/参考电极工作。在图6A至6C的实施例中,在考虑工作电极的情况下,指示电极512可扮演第二反向或反/参考电极。来自指示电极或工作电极的测量可结合(例如,叠加或平均)那些来自第一反/参考电极/工作电极以获取更精确的测量。在一实施例中,指示电极作为第二工作电极与反电极或反/参考电极一同工作。在另一实施例中,指示电极作为第二工作电极与第二反电极或反/参考电极一同工作。在另一实施例中,指示电极作为第二反电极或反/参考电极与第二工作电极一同工作。
探测器或探测器读数器可包括一有效反应指示电极以报告用户测量区已被注入的标记(例如,一可视信号或音频信号)。当指示电极指示测量区已被注入并报告或不报告用户时,探测器或探测器读数器可初始化一读数。读数可被初始化。例如,通过应用工作电极和反电极之间的电压并开始监测工作电极上产生的信号。
生产探测器的通用方法
现在参考图13A和13B,用于制造薄片探测器的方法的样例之一是考虑显示于图5A至5C中探测器的排列来描述的,尽管此方法可被用于制造不同其它的探测器排列,包括那些在下面描述的。当图5A至5C的3个层被装配时,探测器420形成了。
在图13A和13B中,基层1000,例如塑料基层,通过所示箭头方向移动。基层1000可以是网上独立的片或连续的卷。多个探测器420可作为其上具有工作电极422(图5A)和具有反电极424和指示电极441、442(图5B)部件1024的部件1022形成于基层1000上。这些工作、反向和指示电极电连接至其相应的线迹和触片。通常,生产的工作电极部件1022占基层1000的一半且生产的反电极部件1024占基层1000的另一半。在一些实施例中,基层1000可被划线和折叠使部件1022、1024一起形成探测器。在一些实施例中,如图13A中所示,独立的工作电极部件1022可在基层1000上一个接一个或相互邻近形成以减少材料的浪费。同样地,独立的反电极部件1024可在基层1000上一个接一个或相互邻近形成。在另一实施例中,独立的工作电极部件1022(和同样地反电极部件1024)可被间隔分开,如图13B中所示。用于生产多个探测器的剩余过程被描述,但可被轻易修改以形成独立的探测器。
碳或其它电极材料(例如,金属如黄金或白金)置于基层1000上以提供用于每个探测器的工作电极422。碳或其它电极材料可通过各种方法包括印刷碳或金属墨、汽相沉积作用和其它方法进行镀覆。印刷可通过丝网印刷、凹版辊印刷印刷、转印和其它已知印刷方法实现。线迹453和触片423适宜一同使用于工作电极422,但可能被用于并发步骤。
类似于工作电极422地,反电极424、441、442(如图5B所示)置于基层1000上。反电极是通过基层上提供的碳或其它导电的电极材料形成的。在一实施例中,用于反电极的材料是银/氯化银液体。反电极的材料可通过各种方法包括印刷或蒸汽沉积作用被沉积。印刷可通过丝网印刷、凹版辊印刷印刷、转印和其它已知印刷方法实现。线迹454、451、452和触片425、443、444适宜一同使用于工作电极424、441、442,但可能被用于并发步骤。
多探测器420适宜同时生产;即用于多个探测器的工作电极包括其线迹和触片被生产在聚合片或网上,且同时或并发地,用于多个探测器的反电极和其线迹和触片被生产(例如,印刷)。工作电极和反电极可置于稍后相互对立的分离的基层上以便于电极相互面对。可选地,为了简化基层的记录,工作电极可置于基层片或网的另一半以便于在面对排列中片或网可被折叠以添加工作电极和反电极。
为了形成样本室426,间隔433置于至少基层/工作电极和基层/反电极其一之上。间隔433适宜是粘合剂间隔,如独立粘合剂层或双面粘合带(例如,具有沉积于对立面上的粘合剂的聚合载体片)。间隔适用材料包括粘合剂如氨基甲酸乙酯、丙烯酸盐、丙烯酸类聚合物、胶乳、橡胶和类似物。
将导致样本室的通道置于间隔433内,通过切掉部分粘合剂间隔或放置两靠近但彼此之间有缝隙的粘合剂片。粘合剂可根据定义通道区的模式被印刷或沉积于基层上。粘合剂间隔可选择地在其被引入探测器前提供一个或多个释放衬垫部。粘合剂可被切割(例如,或切开)以移去在基层上沉积间隔之前相应通道的部分粘合剂。
在本发明的一个方法中,图示于图14A至14G中,粘合剂包括第一和第二释放衬垫部。在使用粘合剂至第一基层/工作电极或基层/反电极之前,粘合剂被轻拂切割轻拂切割过第一释放衬垫和至少部分粘合剂的下面,适宜整个粘合剂但不到第二嵌入件,以形成一个或多个部件,部件之一将最终导致样本室。第一释放衬垫移走超过其上长度的粘合剂但不保留其上的样本室。曝光粘合剂被涂到第一基层/工作电极或基层/反电极上。在除去第二释放衬垫部时,置于样本室部件内的粘合剂也被除去。在粘合剂间隔层内留下了通道或开口。第二基层/工作电极或基层/反电极则使用粘合剂以形成分层探测器构件。
图14A至图14G详细描述了通过“轻拂切割”的粘合剂层的处理。最终成为间隔433的粘合剂层适宜从包括第一释放衬垫1020和第二释放衬垫部1040之间的粘合剂层1030的粘合剂构件中获取。刀具(如刀或模刀)切透第一释放衬垫1020和至少下面粘合剂层1030,但是不切割第二释放衬垫部1040,如图14B和14G中所示,以形成释放衬垫部1020a、1020b和粘合剂部分1030a、1030b。1030b占用的空间是将导致探测器样本室的地方并作为“样本室区域”被提到。如图14G中所示的切割装置允许移走一个释放衬垫部部1030a,剩下后面的释放衬垫部部1030b。嵌入件可被切割成单独的延伸至嵌入件整个长度的条;则这将需要移走每个独立的嵌入件条。
释放衬垫部1030a被移动以供给如图14C中所示的粘合剂装置。暴露的粘合剂位于基层1050之上且可靠地粘附于其上,如图14D所示。没有释放衬垫部的粘合剂部件1030a将粘附于基层1050上。如图14E中所示,第二释放衬垫部1040被取走,随之拉动粘合剂的切断无粘接部分1030b和第一嵌入件1020b;这导致提供其间具有样本室426的间隔层部分433a、433b的粘合剂区1030a,如图14F中所示。第二基层则置于粘合剂层上且通过间隔433被辗压至第一基层。间隔433的厚度通常决定了工作电极和反电极之间的空间,并因此影响样本室426的体积。在单独探测器和/或一批探测器内各探测器之上的厚度变化适宜不超过±5%。用于生产分层探测器构件的“轻拂切割”法的使用保持了生产期间完整的样本室壁,因此提供了更可靠、可再生的样本室体积。
不滤出或可扩散氧化还原催化剂和/或第二导电剂置于在至少样本室区域内的基层之上。如果这些部件中其一或全部是不滤出的,该部件或全部适宜置于工作电极上。如果这些部件中其一或全部是可扩散的,该部件或全部部件可置于通道区域内的基层的任意表面。氧化还原催化剂和/或第二导电剂可单独或一起置于定位间隔之前或之后的基层上。氧化还原催化剂和/或第二导电剂可通过各种方法包括,例如,丝网印刷、喷墨印刷、喷印、描绘、沿对齐和/或邻近电极的行或列剥离和其它类似的方法被放置。其它部件可分别或共同使用氧化还原催化剂和/或第二导电剂被放置;这些部件可例如包括表面活性剂、聚合物、聚合物膜、防腐剂、粘合剂、缓冲剂和交联剂。
放置间隔、氧化还原催化剂、第二导电剂、传感层和其它类似东西后,第一和第二基层(其上具有工作和反电极)被相互对立放置以形成探测器。基层的各面是通过间隔的粘合剂结合的。在各面结合之后,独立探测器适宜使用各种方法包括,例如,钢性切割、撕裂或其它切离多余基层材料和分离独立探测器的方法从探测器网中被切掉。在一些实施例中,切割或撕裂相结合的方法被使用。作为另一可选方法,独立探测器部件可首先被切离基层,然后则合并以通过粘合两部件例如通过使用间隔粘合剂形成探测器。
探测器的侧面可直接允许探测器通过在并行方向内使用如一组直刀系统撕裂基层从基层剩余部分和/或从其它探测器被切离。探测器的边缘可决定样本室和/或测量区域的边缘。通过精确控制切刀之间的距离,样本室体积的不同性通常可减少。在一些实例中,当并行切割通常是最简单的再生产时,这些切刀适宜相互并行排列。
连接电设备的探测器
现在参见图16A和16B、17A和17B、18A和18B,图5A至5C(如参见探测器1420一样)的被组装的探测器通常通过装置用于与探测器1420的终端触片423、425、443、444连接和接触的电插头件1500连接表或其它电设备。探测器表通常包括稳压器或其它部件以提供用语探测器电极的电压和/或电流。探测器读数器通常还包括用于从探测器信号中检测分析物浓度的处理器。探测器表还包括显示器或用于连接显示至探测器的端口。显示器显示探测器信号和/或从探测器信号包括,例如,分析物浓度、分析物浓度的变化率和/或分析物浓度开始超出的检测结果(指示,例如,次于或高血糖症)。
适用插头件的样例之一显示于图16A和16B、17A和17B、18A和18B中。插头件1500(被用于连接探测器至表或其它电子设备)通常是两个具有顶部1510和底部1520(如图16B所示)的部分构件。被定位于其间并通过顶部1510和底部1520被保护的是提供探测器1420和表之间电连接的接触引线1423、1425、1443、1444。这些引线1423、1425、1443、1444具有用于物理触片423、425、443、444(分别图示于5A和5B中)的近端和用于连接任何配件表的远端。通过将探测器1420放入支撑和保留探测器的滑动区1530,具有触片的探测器1420的终端可被滑入或紧密配合插头件1500。为了工作电极和反电极正确连接表,通常插头件1500的接触构件与探测器恰当的垫产生电接触是重要的。
可选特性之一是插入监测器1450,图示于16A和16B中,是探测器插入插头件1500之前的仰视图。此导电插入监测器位于非导电基层上并具有用于与插头件电接触的触片。当探测器被正确插入插头件中时,插入监测器被装配和设计用于闭合两接触构件1451和1452之间的电路。正确插入插头件1500意味着探测器条带1420被右侧朝上插入,即条带的正确端被插入插头件,且条带被插入插头件足够远以便在条带上的电极触片和插头件的相应接触构件之间产生可靠的电连接。除非所有的电极垫已正确接触插头件1500的接触构件,更适宜产生不闭合电路。插入监测器可具有不同于穿越探测器宽度的条带的形状;例如,其它设计包括独立的圆点、栅格式样或可包括格式上的特性,例如文字或字符。
因为此插入监测器1450不在具有接触区的电极的端部,插入监测器1450不需要在探测器上附加宽度空间。触片443、425、444、423的宽度被定义为可放置将导致电连接的引线的宽度;通常,接触宽度是显露接触区的宽度。在一实施例中,插头件(例如,1451、1443、1425、1444、1423、1452)上的六个接触引线构件可接触与4个触片(例如,443、425、444、423)具有同样宽度的探测器1420。在占用宽于探测器宽度的探测器上的具有触点的概念可被用于任何数量的触点;这可和或不和插入监测器一起使用。
作为特别的样例,4个引线1443、1425、1444、1423产生与触片443、425、444、423的接触。如果每个引线和/或触片是1微米宽,至少4mm宽的探测器需要产生接触。另外的引线,例如那些用于插入监测器1450(例如,接触引线1452、1452),可通过沿引线1443和1423侧面延伸且然后成角度朝向引线1443、1425、1444、1423接触条带1420的点后的条带1420的中心的具有的引线1451、1452产生接触。插入监测器跨过探测器1420的侧边在引线1451、1452上划线以与探测器产生接触,因此不需要附加的探测器宽度。
接触构件是平行和非交迭的且它们从远端到近端纵向运行。引线构件1443、1425、1444、1423终止于其近端,但是引线构件1451、1452持续纵向经过引线构件1443、1425、1444、1423的近端。一旦经过近端、引线构件1452,1452成角度朝向探测器条带的中心。
插入监测器还可用于在测试条带上编码信息。编码信息可以是,例如,用于大量制造或特定条带的校准信息。这样的校准信息可能与条带的敏感度或其校准曲线的y轴有关。在一实施例中,插入监测器包含2个或更多个用语连接表的触片。该2个或更多个触片通过导电材料例如导电墨水相互连接。在2个或更多个触片之间的导电通路的阻抗与编码信息有关。作为离散校准值的样例,所给范围内的阻抗值可对应于同一校准设置,不同范围内的阻抗值可对应于不同的校准设置。作为连续校准值的样例,校准设置可以是一连续作用的阻抗。触片之间适用导电通路的样例显示于图19A至19L。
在图19A-19F中,具有不同阻抗的多个导电通路被印制于条带上。为了它们不携带电荷,通路的阻抗是通过切割或刻划一些或所有导电通路变化的。在图19G-19L中,阻抗是通过导电通路的长度或宽度被控制的。当它被首选用来提供插入监测器上的此编码信息时,使用条带上独立的导电线迹也可独立地实现插入监测器功能和信息编码是公认的。
在另一实施例中为了确保探测器正确插入表中,表应包括上升区或防止或阻碍以不正确的方向插入探测器的突出部,如图20中所示。为了确保探测器1100正确插入插头件1110,插头件1110应包括防止或阻碍以不正确的方向插入探测器的上升区1140。例如,第二基层1130的接触区的宽度w2应宽于第一基层1120的接触区的宽度w1。在此实例中,上升区1140被定位于允许探测器1100被滑入插头件以便第一基层1120靠近突出上升区1140的表面,但是将防止或阻碍具有靠近突出上升区1140的表面1150的第二基层1130。除了上升区的其它物体也可用于指导用户以探测器的正确方向插入表中。
完整样本获取和分析物测量装置
分析物测量装置依照本发明原理的结构通常包括一探测器,如上文描述,结合样本获取设备用于提供一套完整的取样和测量装置。样本获取设备通常包括,例如,皮肤刺破部分,如柳叶刀,即其可被注入病人的皮肤以获取血液,在一优选实施例中,完整样本的获取和分析物测量装置包含具有柳叶刀和测量条带的切开器具。切开器具适宜要求能够活动竖起。通过要求用户在使用之前竖起装置,无意地触发柳叶刀的风险被最小化。切开器具还适宜允许用户调整柳叶刀穿过皮肤的深度。这样的装置是可从如公司如Boehringer Mannheim andPalco公司买到的商业产品。此特性允许用户调整切开器具用于不同的皮肤厚度、皮肤经久力、穿过身体上的不同地方和穿过不同用户的皮肤敏感度。
通常,当血管遍布皮肤破孔处周围时,大量的体液样本如血液或裂缝液体快速产生。具有突出环的样本获取装置可被使用,如图21中所示。环1200圆周地包围切开地方以增加压力并挤出伤口的更多样本。柳叶刀将从环1200的中心1220处突出。环1200具有依靠皮肤挤压的表面积1210,因此增加了皮肤上的紧张状态并经常造成皮肤肿起。皮肤被拉紧且甚至伸展,从伤口处产生大量的液体。通过环1200产生的增加面积和更紧的皮肤减少了在刺破期间病人感受到的疼痛。通常进一步有减少瘀伤的趋势。
在一实施例中,刺破器具和表被集成到单独的装置中。为了操作装置,用户只需要插入一可任意使用的包含测量探测器和刺破装置的筒至集成装置中,竖起刺破器具,被对皮肤按压它以刺激它,并读取测量结果。这样的集成刺破器具和测试读取器为用户简化测试过程并最小化处理体液。
探测器和仪表的操作
本发明的电化学探测器可用或不用施加跨过电极的电压被操作。在一实施例中,电化学反应自然地发生且电压不需要施加在工作电极和反电极之间。在另一实施例中,可能保持或可能不保持连续的电压被施加在工作电极和反电极之间。所需电压的量依赖于使用的氧化还原催化剂。电极平衡自身或通过使用外部斜线被平衡且分析物被电解的电压通常是这样的,即电化学反应被驱使或接近完成,但是它更适宜不充分氧化以产生重要的可影响信号测量的电化学反应干扰,例如尿酸盐、抗坏血酸盐和醋氨酚。为了不滤出氧化还原催化剂,通常电压相对标准氯化亚汞电极(SCE)在大约-350mv和+400mv之间。氧化还原催化剂的电压更适宜负于+100mv,也更适宜负于0mv,最适于相对SCE负于大约-150mv。
当使用外部电压时,其可在样本置于样本室之前或之后使用。如果测量区仅包括样本室的一部分则电压更适宜在样本进入并驻留在样本室之后被使用以防止当样本室被注入时样本流过测量区。可选地,在测量区包括多个或所有样本室的情况下,电压可在不影响化验精度的样本室注入前或期间使用。当电压被使用且样本在测量区时,电流将在工作电极和反电极之间流动。电流至少部分地是样本内分析物电解的结果。通过氧化还原催化剂和可选的第二导电剂发生电化学反应。对于许多生物分子,B,通过下面的反应等式描述过程:
酶
nA(ox)+B---->nA(red)+C (1)
nA(red)----->nA(ox)+ne- (2)
生物分子B通过氧化还原催化剂A在适当的酶中被氧化成C。氧化还原催化剂A则被氧化于电极上。电子通过电极被收集且产生的电流被测量。被测量的电流还可包括导致被测量的基电荷的基电流,至少部分地由于可扩散氧化还原催化剂在工作电极和反电极之间的穿梭。此基电流可被最小化或可计算,如PCT应用PCT/US99/23425中所描述。
多种技术可用来检测样本中分析物的浓度。这些技术包括,例如,电量分析,电流分析和电压分析。为了通过电量分析检测样本中分析物(例如,葡萄糖)的浓度,在分析物的电解期间检测工作电极和反电极之间通过的或被射出通过的电荷。电荷的认识和样本的体积允许样本中被电解的分析物的浓度的计算。电荷可通过多种方法被检测。
例如,电荷可被直接测量。这可使用电量分析或已知的电量分析技术完成。通常,电荷在分析物电解完成或接近完成期间被测量。
作为另一个例子,电荷从电解电流it,总时间,t的测量中被检测。测量系列时间(tx,tx+1,tx+2,...)内的系列电流(ix,ix+1,ix+2,...)。则电流可被结合(例如,使用已知用数字表示的方法数字地结合)以供给电荷。在一些实例中,电流在整个电解期间测量。在其它实例中,电流在时间周期后被推断且使用测量电流和推断电流的结合检测电荷。
电流的推断利用在至少一部分电解期间内电流和时间之间的设计关系。通常,当系统是可扩散限制的,电流的自然对数与时间是线性关系。这通常发生在探测器“平衡”期间内时间周期后。图15A是用于先前所述探测器之一内的分析物电解的电流相对时间的图例,例如葡萄糖;图15B是相同数据的电流相对于时间的自然对数图。在样本完全注入样本室后,在探测器平衡时间内,电流增长至峰值,如图15A和15B中“P”所示。通常峰值发生在系统是动态地胜过可扩散地被限制的时间周期期间。通常,电流则开始减少,虽然,在一些实例中,在电流变成扩散限制后发生电流进一步增长。最终,电流值进入一个在电流和时间的自然对数之间呈线性关系的区域,如图15B中所示的“L”。电解保留的部分分析物所需的电流则可使用估算法,例如非线性或,更适宜线性估算法(例如,线性最小平方技术)推断出来。推断发生区域如图15B中“E”所示且推断为所示实线。
就上述论述而言,该电流值是实际电流的绝对值,因此,电流测量标记被忽略了。例如峰值不论是阳极或阴极都最远离0电流的。
当系统是扩散限制周期内,电流和时间的自然对数之间的关系是线性的。完全电解样本中保留的分析物需要保留的电荷可从此线的斜率可靠地估算。必须谨慎以保证在实施估算前系统处于可扩散限制范围。保证系统是可扩散限制体制的方法之一包括观察电流值直到达到电流峰值,ipeak,(“P”)。持续观察电流值直到电流下降低于极限值,ithresh,其通常是峰值的分数。例如,极限值可以是峰值的二分之一、三分之一或四分之一(例如,ithresh=j*ipeak,j例如是0.5、0.33或0.25)。为了探测器具有系统在此时间内是可扩散限制的高可信度,极限值是基于探测器特性选择的。
可使用其它的方法来保证系统是可扩散限制体制。例如,方法之一是观察ipeak后的电流值直到达到变形点且第二派生自然对数的电流转向阳极。在这一点上系统通常是可扩散限制体制。
达到极限值之后,使用两个或多个测量电流值的自然对数测定斜率值,(例如,mx=(log(ix)-log(ix-y))/(tx-tx-y))其中mx是时间tx的斜率,ix是时间tx的电流,ix-y是时间tx之前tx-y的电流。虽然使用任意两个电流值的自然对数可测定斜率(例如,电流值直接一个接一个地测量),斜率更适宜使用多个连续电流值或至少间隔10(例如,y=10),更适宜至少间隔大约30(例如,y=30)的电流值的自然对数被检测。此过程可减少系统中随机干扰的影响。随意地,多个连续的斜率值(例如,3或5或10个斜率值)可被观察用于比较。例如,在认可用于估算使用的斜率值之前,系统可寻找10个单调减少的斜率值。
检测的斜率值用于推断完全电解样本中保留的分析物所需的电荷。即,电流被推断为0电流。已知推断技术(例如,线性推断技术)可被使用。电解分析物所需的总量电荷可通过增加测量电荷和推断电荷检测。
电流值(或其它测量值)还可用于监测探测器和表的运行。例如,如果有失败的测量(例如,探测器被拉出测量装置,等等),可检查电流值比率以检测。认可的比率范围通常依赖于探测器的类型和部件、测量得到的概率和认可的干扰级。作为一个例子,认可比率范围可以是,例如,立即接近测量的2∶1或1∶2。
上述讨论集中在可扩散限制条件下使用电流相对于时间的自然对数的斜率推断样本内分析物的完全电解所需的电荷。本领域技术人员将重新认知到此斜率与有效扩散系数相关,并且涉及有效扩散系数的其它线性或非线性数学函数也可用于推断电荷。
电流测量的推断和通过或喷射通过的电荷以及分析物浓度的检测和其它功能可通过一具有或不具有存储介质的处理器实现,所需的程序是通过软件、硬件或软硬结合实现的。依据另一实施例,这些同样的程序是通过使用离散的或半可编程的硬件装置完成的,例如,使用硬件描述语言,如Verilog。在另一实施例中,程序是使用处理器执行的,该处理器具有至少一个查询表,用于存储表现基于所给输入数据的上述等式的完成结果或部分结果的数据。
电流测量可通过多种方法实现。例如,电流测量可通过使用已知技术和装置直接测量电流来实现。
测量电流的另一方法包括释放已知量的电荷至样本中(通过电解分析物)并测量放电所需时间。电流则被计算为电荷与放电时间的商。作为一个例子,电容器可通过表中电路充电然后连接至工作电极和反电极通过电解分析物放电。放电至极限的时间可使用例如时钟电路测量,该时钟电路是表处理电流的一部分。时钟电路的使用使得时间的测量非常精确。这是超越本设计的优点,即直接测量电流或电荷并使用更昂贵的A/D(模拟/数字)转换器将这些模拟测量转换成可处理的数字表示法。
提供电流值的电荷和时间的测量精度影响分析物测量的最终精度。尽管需要使用高质量和高精度的测量装置,用于存储电荷的电容器可以是具有先前已知电容的高质量、昂贵的电容器。可选地,精确电荷测量可通过使用并联于电容器的校准电阻获得。高质量、非常精确的电阻通常比同样精度的电容器便宜,且提供同样的电荷测量精度。
电荷,Q,不论如何检测,是通过下列等式被用于计算分析物浓度(CA)(当氧化还原催化剂是不滤出时):
CA=Q/nFV (3a)
其中,n是电解分析物所需的电荷等价物的数量,F是法拉第恒量(大约每等价物96500库仑),V是测量区中样本的体积。当使用可扩散催化剂时,分析物的浓度可从下面的等式中获得:
CA=(Qtot-Qback)/nFV (3b)
其中,Qtot是测量期间电荷传输的总量,Qback是非用于分析物传输的电荷量,例如通过工作电极和反电极间的可扩散催化剂的穿梭传输的电荷。在至少一些实例中,探测器如此构造以便于基电荷是通过电解大量分析物产生的电荷数量的至多5倍。基信号适宜是通过电解分析物产生的电荷的至多200%、100%、50%、25%、10%或5%。
用于检测基信号的比率以通过电解分析物产生信号的方法的样例之一如下描述。如果氧化还原催化剂的穿梭是不能通过电压实现的,穿梭带来的电荷可通过下面的公式表现:
Qback=(AFDMCM/d)(tnM)
其中,A是工作电极的面积;F是法拉第恒量(大约96500库仑/等价物);DM是氧化还原催化剂的有效扩散系数;CM是测量区内氧化还原催化剂的浓度;d是对电极的分隔距离;t是用于测量的时间量;nM是通过氧化还原催化剂获取或损失的电子的数量。
另外,当测量期内分析物被电镀氧化大约完成90%时,分析物的电荷可通过下面的公式表示:
QG=Ad(0.90)CGnGF
其中,A是工作电极的面积;d是对电极的分隔距离;CG是葡萄糖的浓度;n是电解分析物(例如,2电子/葡萄糖分子)所需的电子数量;F是法拉第恒量。对于葡萄糖,当CG是5mM(或5*10-6克分子/cm3),t是60秒,nG是2,nM是1,来自氧化还原催化剂的电荷到来自分析物电镀氧化的电荷的比率可通过下面的等式表示:
QBack/QG=(DMCM/d2)(tnM/(0.9nGCG))=(DMCM/d2)*(6.7*106)
例如,如果QBack/QG的比率是5,DMCM/d2则是7.5*10-7克分子/(cm3秒)。还比如,如果QBack/QG的比率是1,则DMCM/d2是1.5*10-8克分子/(cm3秒)。因此,依赖于所需的比率,探测器可通过选择DM、CM和d而装配具有所需的比率。
比率可受到影响,例如,通过降低氧化还原催化剂的浓度(例如,减小CM)。二者选一或另外地,降低氧化还原催化剂的扩散性。其它探测器装配还适用于控制基信号的比率以通过分析物产生信号并在下面描述。
基电荷Qback可通过多种方式计算。Qback可被定为小,例如通过使用单一的、限制的扩散氧化还原催化剂的数量;通过提供限制氧化还原催化剂扩散至反电极的反电极之上的隔膜;或通过在工作电极和反电极之间具有相应的小压差。探测器装配的其它例子和方法适用于降低Qback包括在工作电极上的氧化还原催化剂反应率值得注目地快于反电极上的;工作电极上的氧化还原催化剂固定不动;氧化还原催化剂稳定了基于反向或反/参考电极上的反应;或减慢氧化还原催化剂的扩散。
用于电量分析测量,至少20%的分析物被电解,适宜至少50%,更适宜至少80%,且甚至更适宜至少90%的分析物被电解。在本发明的一实施例中,分析物完全或接近完全被电解。在电化学反应期间,电荷可从测得的电流中计算出,且使用等式(3a)或(3b)可决定分析物的浓度。当电流达到稳定阶段值时,完全的电化学反应通常是标志。这表示所有的或接近所有的分析物已被电解了。用于这类的测量,通常至少90%的分析物被电解,适宜至少95%的分析物被电解,更适宜至少99%的分析物被电解。
用于电量分析,其通常被描述为分析物被快速电解。电化学反应的速度依赖于多种因素,包括施加于电极之间的电压和反应(1)和(2)的动力。其它重要的因素包括测量区的尺寸。通常,电压越大,因此而通过电池的电流越大,通常反应发生的越快。然而,如果电压过大,其它电化学反应可能造成测量中的重大错误。通常,基于样本内分析物的预期浓度选择电极间的电压以及特定的氧化还原催化剂和可选的第二导电剂是为了在少于5分钟内分析物几乎被完全电解。适用于在大约2分钟内分析物几乎被完全电解,更适用于大约1分钟内。
虽然电量分析有需要知道测量样本体积的缺点,电量分析是用于分析少量样本的优选技术,因为其具有优点,例如,测量不依赖于温度、测量不依赖于酶活跃性、测量不依赖于氧化还原催化剂的活跃性和没有从样本中的分析物损耗中的测量错误。如上所描述,电量分析是一种用于检测在分析物的完全或接近完全电解期间通过的或喷射通过的电荷总量的方法。一种电量分析技术涉及电解工作电极上的分析物并测量在两次或多次电解周期内工作电极和反电极之间产生的电流。当电流达到稳定状态时,电解是完全的。通过结合整个时间所测量的电流并计算基信号用于电解样本的电荷被计算出来。因为电荷直接涉及样本中分析物的量,那有不依赖于温度的测量。另外,酶的活跃性不影响测量值,但是仅仅需要时间来获取测量(例如,酶越不活跃,需要越长的时间来达到完全电解样本)以便随时间衰退的酶将不实施分析物浓度的不精确检测。并且最终,通过电解的样本内分析物的损耗不是错误源,而是更正确的技术目标。(然而,如果电解曲线是从基于电化学原理的部分电解曲线中推断出来的,则分析物不需要被完全电解。)
在一些实例中可能需要利用非电量分析的化验,例如电流分析或电压分析测量技术。“电流分析”和“时间电压分析”是指在一定时间内采用一点或多点的电压分析测量。当被测样本体积已知时,这些测量技术是有用的;如果生产一个或多个尺寸的测量区的公差具有重大的不同,小体积探测器(例如,不超过1微米)的测量区内的样本体积很困难被精确再生产。为了获得关于使用非电量分析测量的信息,例如电流分析和电压分析技术,请看如1999年4月21日的美国申请序列号09/295,962。
加热样本
样本可被加热以增加扩散率、氧化率或减少分析物。加热可通过多种技术包括置探测器于热环境中或给探测器使用加热部件完成。
另一技术包括提供热的加热器件,例如,加电线或将电能转化为热能的液体器件于探测器上。电线或液体器件可使用于一个或多个工作、反向、参考或反/参考电极基材如聚合物薄片的背面,或包围工作、反向、参考或反/参考电极的外围。在一些实例中,样本被加热高于初始温度的5至20℃。在其它实例中,样本的温度可能不知道,但是大量的持续电能和电流使用于电线或液体中。
普通例
通过下面的普通样例进一步描述本发明的特性。这些例子没有限制发明范围的意思,本发明的范围在先前的描述中已全部阐明。在本发明设想内的变形方案对本领域技术人员是显而易见的。
如图5A至5C中所示的一种用于生产具有工作电极、多个反/参考电极和侧注样本室的探测器的方法在下面描述。依据其中描述的方法,多个探测器被生产然后被分开。
第一非传导基层,适宜聚酯,被提供。传导的碳墨可从Ercon ofWareham买到的产品(商标设计“#G4491”),在如图5A中所示样式下被丝网印刷到第一聚酯基层的第一部分并干燥以提供工作电极422、线迹453和触片423。一旦基层网被切割成最终尺寸,每个工作电极422将延伸跨过探测器的宽度并具有伸向探测器远端的线迹453。作为一个例子,探测器可被制成宽度大约6.1mm(0.240英寸)。通常的探测器宽度大约为2mm至20mm,适用于大约4mm至10mm,但是更宽或更窄的探测器可被用作期望。
如美国专利应用序列号09/295,962中描述,包含可扩散催化剂和可扩散葡萄糖脱氢酶的传感层被应用于样本室区域内的工作电极。传感层可在提供样本室之前或同时被置于电极上。在聚酯基层的另一半上,导电银/氯化银墨如可以从Ercon买到的(商标设计“Silver/SilverChloride#R414”)产品如图5B中所示地下被丝网印刷于第一聚酯基层的第二部分并干燥。在图5B中所示的实施例中,银/氯化银液提供第一指示器或参考电极441、反电极424和第二指示电极442。反电极可延伸跨过整个探测器的表面,或只是其上的一部分。作为一个例子,反电极的宽度大约为1mm至20mm,适用于大约2mm至10mm。在一探测器装配中,反电极424宽度大约为3.71mm(0.146英寸)。指示电极具有的宽度,例如,大约为0.1mm至5mm,适用于大约0.25mm至大约1mm。
在一探测器装配中,例如图5A中所示的工作电极422,工作电极伸向探测器的宽度大约为6.1mm(0.240英寸)。反电极,例如反电极424,具有大约为3.71mm(0.146英寸)的宽度。例如图5B中的指示电极441、442,每个指示电极具有大约为0.51mm(0.020英寸)的宽度。0.30mm(0.012英寸)的间隔位于这些指示电极和反电极之间。为了电极441、442不被破坏,例如,抹掉、加上条纹、碎裂或其它类似的破坏,通过分割基层至独立的探测器中的处理,指示电极可从探测器条带的最终侧边缘回调,例如,通过大约0.38mm(0.015英寸),
已经参见各种具体优选的实施例和技术方案描述了本发明。但是,对本领域普通技术人员来说,在本发明的范围和精神范围内,可以做出许多变形和修改。
Claims (22)
1.一种探测器,它包含:
具有第一主表面和对立于第一主表面的第二主表面的第一基层;具有第一主表面和对立于第一主表面的第二主表面的第二基层,放置第一和第二基层使第一基层的第一主表面面对第二基层的第一主表面;
置于第一基层的第一主表面上的工作电极;
置于第一基层和第二基层之一的第一主表面上的反电极;和
置于第一基层和第二基层之一的第二主表面上的插入监测器,监测器被装配和设计用于提供指示探测器已正确插入表中的表的至少两个接触引线之间的电流通路。
2.如权利要求1所述的探测器,其特征在于,插入监测器被置于第一基层的第二主表面上。
3.如权利要求1-2之一所述的探测器,其特征在于,反电极被置于第二基层的第一主表面上。
4.如权利要求1-3之一所述的探测器,其特征在于,探测器具有宽度,且插入监测器是延伸跨过探测器宽度的、导电的条带。
5.如权利要求1-4之一所述的探测器,其特征在于,插入监测器具有两个或更多个用于与表电接触的接触区。
6.如权利要求1-5之一所述的探测器,其特征在于,插入监测器被装配和设计用于提供关于条带的编码信息。
7.一种探测器带,包含:
具有第一主表面和对立于第一主表面的第二主表面的第一基层;
具有第一主表面和对立于第一主表面的第二主表面的第二基层,放置第一和第二基层使第一基层的第一主表面面对第二基层的第一主表面;
置于第一基层的第一主表面上的工作电极;
置于第一基层和第二基层之一的第一主表面上的反电极;和
置于第一基层和第二基层上的多个触片,至少触片之一与工作电极电连通且至少另一触片与反电极电连通,其中每个触片具有平行于第一和第二基层宽度的测量触片宽度,且其中触片宽度的总和大于第一基层的宽度且大于第二基层的宽度。
8.如权利要求7所述的探测器条带,其特征在于,多个触片被置于至少三个下述表面上:第一基层的第一主表面、第一基层的第二主表面、第二基层的第一主表面和第二基层的第二主表面。
9.如权利要求7-8之一所述的探测器条带,其特征在于,它还包含:
置于第一基层和第二基层之一的第二主表面上的、导电线迹,导电线迹电连接至两个或更多个用于与插头件电接触的触片,导电线迹被装配和设计用于闭合电电路,且其中导电线迹具有载有关于探测器的信息的电阻。
10.一种电化学探测器装置包含:
(a)电化学探测器包含
(ⅰ)至少一个工作电极,
(ⅱ)至少一个反电极,和
(ⅲ)一个用于保留体液样本的、与至少一个工作电极和至少一个反电极电解接触的样本室;和
(b)测量装置包含
(ⅰ)电容器被装配和设计用于联接至少一工作电极以通过反复放电来反复释放适量电荷,用于电解位于样本室内体液内的至少部分分析物,
(ⅱ)测量电容器放电时间的时钟,和
(ⅲ)基于放电时间确定体液内分析物浓度的处理器。
11.一种插头件,它包含:
用于可释放地连接电化学分析物探测器的多个接触构件,其中每个接触引线包含一个用于电连接探测器触点的近端,和一个用于电连接电设备的末端;且其中多个接触引线包含一个或多个从末端到近端纵向延伸的接触引线,和一个或多个从末端到一个或多个第一接触引线的近端纵向延伸的第二接触引线并以一定角度朝向探测器的纵向中心线。
12.如权利要求11所述的插头件,其特征在于,插头件包含至少两个与探测器的单独导电表面电接触的第二接触引线。
13.如权利要求12所述的插头件,其特征在于,第一接触引线被装配和设计用于接触至少探测器的反电极和工作电极之一,且其中第二接触引线被装配和设计用于接触探测器的插入监测器。
14.制造如前述权利要求之一所述的探测器的方法,该方法包含步骤:
提供具有覆盖第一和第二释放衬垫部的第一和第二表面的粘合剂;
切透第一释放衬垫但不切透第二释放衬垫,以形成多个样本室区域;
在样本室区域之上,移去部分第一释放衬垫以显露部分第一粘合剂面留下第一释放衬垫的保留部分;
将显露的第一粘合剂面施加到第一基层上;
连同粘合剂和样本室区域的第一释放衬垫一起移去第二释放衬垫部以显露第二粘合剂面和样本室区域内的第一基层;和
在样本室区域内形成样本室的第二粘合剂面上施加第二基层,其中多个导电的线迹被置于第一基层、第二基层或其组合之上,导电线迹定义了至少一个工作电极和至少一个反电极,且样本室被设置为允许样本室内的分析物样本通过工作电极和反电极间的电流流动被电解;且隔离多个电化学探测器,每个电化学探测器包含至少其中一个工作电极、至少其中一个反电极和至少其中一个样本室。
15.如权利要求14所述的方法,其中工作电极被置于其中一个基层上且反电极被置于另一基层上。
16.一种检测体液样本内分析物浓度的方法,方法包含步骤:
置体液样本于如权利要求1-13的任何所述的电化学探测器的样本室内,电化学探测器包含至少一个工作电极和至少一个反电极用于电解电化学探测器样本室内体液样本内分析物;
通过至少一个工作电极和至少一个反电极之间造成电流流动来电解体液样本内的至少部分分析物;
在分析物电解期间,当探测器内分析物的电解被充分地扩散限制时,检测获得的电流值的至少一些电流值;
当探测器内分析物的电解被充分地扩散限制时,从获取的电流值检测参数来推断电流值和时间之间的关系;
从多个电流值检测消耗于样本内分析物的部分电解中的有效电荷的数量;
从用于推断电流值和时间之间关系的参数,确定电解保留在样本中的分析物所需的推断电荷;
从有效电荷和推断电荷检测体液样本中分析物的浓度。
17.权利要求16所述的方法,其中确定用于推断电流值和时间之间关系的参数的步骤包括确定关于探测器内分析物扩散系数的值;
18.权利要求16-17之一所述的方法,其中确定用于推断电流值和时间之间关系的参数的步骤包括当探测器内分析物的电解被充分扩散限制时,确定电流值的自然对数相对于获得的时间的斜率。
19.电化学探测器装置包含:
(a)如权利要求1-13之一所述的电化学探测器,该探测包含:
(ⅰ)至少一个工作电极;
(ⅱ)至少一个反电极;
(ⅲ)一个用于保留体液样本的样本室与至少一个工作电极和至少一个反电极电解接触的;和
(b)联接于电化学探测器的处理器,处理器被装配和设计用于
(ⅰ)通过在至少一个工作电极和至少一个反电极之间造成电流流动,电解体液样本内至少部分分析物;
(ⅱ)在分析物电解期间,当探测器内分析物的电解被充分地扩散限制时,确定获得的电流值的至少一些电流值;
(ⅲ)从当探测器内分析物的电解被充分地扩散限制时获取的电流值,确定用于推断电流值和时间之间的关系的参数;
(ⅳ)确定消耗于样本内分析物的部分电解的有效电荷量;
(ⅴ)确定电解保留在样本中分析物所需的推断电荷;且
(ⅵ)从有效电荷和推断电荷确定体液样本中分析物的浓度。
20.一种确定用于电解放在如权利要求1-13任何之一所述电化学探测器内的体液样本中的部分分析物的电流量的方法,此方法包含:
将电荷适量放电至位于电化学探测器内的体液样本内并电解分析物;
确定释放该适量电荷所需要的时间量;且
使用电荷量和时间量来确定用于电解部分分析物的电流;
21.如权利要求20所述的方法,进一步包含通过电容放电提供电荷。
22.如权利要求20-21任何之一所述的方法,进一步包含通过经一已知电阻值的电阻器放电电容器,并且测量关于放电的电流或时间常数,来校准电容器。
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- 2000-10-27 DE DE60020076T patent/DE60020076T2/de not_active Expired - Lifetime
- 2000-10-27 AU AU12347/01A patent/AU776764B2/en not_active Ceased
- 2000-10-27 EP EP00973899A patent/EP1145000B8/en not_active Expired - Lifetime
- 2000-10-27 WO PCT/US2000/029540 patent/WO2001033216A1/en active IP Right Grant
- 2000-10-27 AT AT00973899T patent/ATE295538T1/de not_active IP Right Cessation
- 2000-10-27 CN CNB008019916A patent/CN1201149C/zh not_active Expired - Fee Related
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2001
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Cited By (12)
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US10067082B2 (en) | 2004-02-06 | 2018-09-04 | Ascensia Diabetes Care Holdings Ag | Biosensor for determining an analyte concentration |
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 |
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 |
CN101363844A (zh) * | 2007-07-24 | 2009-02-11 | 生命扫描苏格兰有限公司 | 测试条和连接器 |
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 |
CN103168230A (zh) * | 2010-11-01 | 2013-06-19 | 卡普森泽公司 | 测量电容的方法和用途 |
CN103168230B (zh) * | 2010-11-01 | 2015-03-18 | 卡普森泽公司 | 测量电容的方法和用途 |
TWI696830B (zh) * | 2019-06-05 | 2020-06-21 | 國立中山大學 | 組合式電化學分析裝置 |
Also Published As
Publication number | Publication date |
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KR100495935B1 (ko) | 2005-06-16 |
KR20010093785A (ko) | 2001-10-29 |
US20020148739A2 (en) | 2002-10-17 |
DE60020076T2 (de) | 2006-03-16 |
AU776764B2 (en) | 2004-09-23 |
US6942518B2 (en) | 2005-09-13 |
US20080283396A1 (en) | 2008-11-20 |
CA2358993A1 (en) | 2001-05-10 |
US20020053523A1 (en) | 2002-05-09 |
ATE295538T1 (de) | 2005-05-15 |
US20020157948A2 (en) | 2002-10-31 |
US6749740B2 (en) | 2004-06-15 |
US20090260985A1 (en) | 2009-10-22 |
JP2003513279A (ja) | 2003-04-08 |
US8066858B2 (en) | 2011-11-29 |
JP4885508B2 (ja) | 2012-02-29 |
DE60020076D1 (de) | 2005-06-16 |
JP2006091022A (ja) | 2006-04-06 |
US6616819B1 (en) | 2003-09-09 |
CN1201149C (zh) | 2005-05-11 |
US20100126884A1 (en) | 2010-05-27 |
EP1145000A1 (en) | 2001-10-17 |
US20090260986A1 (en) | 2009-10-22 |
WO2001033216A1 (en) | 2001-05-10 |
US20020084196A1 (en) | 2002-07-04 |
US20040225230A1 (en) | 2004-11-11 |
EP1145000B1 (en) | 2005-05-11 |
EP1145000B8 (en) | 2005-09-14 |
CA2358993C (en) | 2005-08-02 |
AU1234701A (en) | 2001-05-14 |
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