CN1606423A - 一种用来检测分析物含量的介入最小的系统和方法 - Google Patents
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Abstract
一种介入很小的分析物检测器件(100)及其使用方法。该系统和方法中所用的器件具有可以涂覆有一种物质(126)的活性电极(104),和其形状至少部分包围该活性电极(104)的对电极(106)。辅助电极(106)和活性电极(104)的形状能提高通过该器件(100)的电流并增加该器件的灵敏度。当该器件被按压在病人皮肤上时,该活性电极(104)适合于透过病人的角质层,其深度小于存在神经末梢的真皮深度。对该活性电极(104)施加一定电势,根据流过该器件(100)的电流或电荷的量测定分析物含量。
Description
发明领域
本发明涉及一种用来检测病人体内分析物含量的介入最小的系统和方法。本发明更具体地涉及使用了一种器件的系统和方法,该器件包括作为活性电极的微探针和包围该活性电极的一至少部分辅助电极,将该器件按压在病人皮肤上能检测体内的分析物含量,产生的疼痛和对病人皮肤的破坏很小。
发明背景
患有糖尿病的人必须定期检查其血糖含量,保证其血糖含量保持在维持健康生活条件必须的正常限度内。血糖含量低,被称为低血糖症,会导致意识模糊,在更极端情况下,导致昏迷和最终死亡。另一方面,血糖含量高,被称为高血糖症,会导致如尿频和口渴等慢性症状,如果长期持续的话,会导致破坏血管,眼睛,肾脏和体内其它器官。
有些患有轻度糖尿病的人可以通过节食来调节其血糖含量。但是,患有中度或重度糖尿病的人必须服用胰岛素使血糖维持在可以接受的含量上。
检测血糖含量的传统方法是直接检测从病人体内抽取的少量血样中的葡萄糖浓度。因此,如果病人希望测试其血糖含量,可以用小针或手术刀进行穿刺,例如在其指尖,让一滴血流入采样器中。但是,这种介入方法对病人而言是疼痛的。而且,必须对穿刺部位和穿刺工具进行仔细消毒,使病原体不会被带入人的血流中。这些方法既麻烦又不卫生,且消耗时间。
作为对传统介入技术的替代,近年来开发出了小型化葡萄糖传感针。这种器件通常包括作为活性电极的带酶的金属基片以及作为对电极和参比电极的相邻金属基片。这种酶通常是葡萄糖氧化酶,它能催化葡萄糖的氧化反应,并在活性电极上采用电化学方法测量该反应的副产物。这种电化学测量受活性电极和对电极/参比(辅助)电极之间所施加电势的影响。在某一特定电势时,由于电极上发生的化学反应,开始产生电流。该电流与电活性物质的浓度有关,从而受测试介质中的葡萄糖量控制。在传统葡萄糖测试片的情况下,测试介质是毛细血管的血;在可植入电极的情况下,该介质是组织。
这些器件通常是较大尺寸的,换言之,其直径大于200微米,长度通常是1厘米或更长。因此,这些器件是介入性的,因为它们能穿刺皮肤深达1厘米。另外,这些器件通常使用传统的针,导线和多层塑料基片,需要复杂的多步骤制造过程,既消耗时间又很昂贵。葡萄糖传感器件的已知例子如美国专利4953552,5680858和5820570,以及PCT出版物WO98/46124中所述。
使活性电极面积最大化,能增加系统的电流响应。特别是在可植入系统的情况下,活性电极面积较小——通常只有片基电极的十分之一。而且,活性电极和对电极/参比电极通常共用同一个的基片——进一步限制了可用的活性面积。这里所述本发明的一个优点是,对电极与活性电极基片是隔开的,可以位于皮肤表面,至少部分包围该介入性最小的工作电极。这种结构能最大化地利用活性电极,而且能使用一个较大的外部对电极。这两方面都能提高系统的信号和性能,同时保持介入最小,使用这种结构时不会引起疼痛。
因此,需要提出一种用来检测病人体内分析物含量的改进的介入最小的系统。
发明概述
本发明涉及用来检测病人体内一种分析物组分,例如葡萄糖的一种系统和方法。该系统和方法中使用一种器件,包含可以涂覆有一种物质,例如葡萄糖氧化酶的活性电极,和包围至少部分该活性电极至少一部分的对电极。该对电极和活性电极的结构能提高通过该器件的电流,因而增加该器件的灵敏度。在用该器件和方法检测病人体内的分析物时,活性电极上可以有一部分与一种物质,例如葡萄糖氧化酶相接触,将该器件按压在病人皮肤上时,活性电极的长度能使该活性电极适合于透过病人的角质层,优选到达几乎不存在神经末梢的深度,能够通过电化学方法检测病人体内的分析物,检测是直接的或者例如是通过与部分活性电极上的物质反应生成一种可被电化学方法检测的物质完成的。如上所述,对电极包围活性电极的至少部分,将该器件按压在病人皮肤时,适合于接触病人的皮肤。活性电极伸出该器件的底座部分至适合于接触分析物的长度,对电极与接近活性电极伸出处的底座部分表面相连。进一步对活性电极施加电势,测量病人体内的分析物与活性电极上物质之间的反应。该器件可以进一步包括参比电极,其与活性电极的距离小于或等于活性电极和对电极任何部分之间的距离,或与活性电极相邻,或与对电极形成一体,在对活性电极施加电势时,使得参比电极提供参比电势。可以使用参比电极来补偿因为皮肤电阻系数改变对器件准确性的影响。
图简要说明
通过以下详细说明和附图,能更容易地理解本发明的这些和其它特征及优点,其中:
图1说明本发明一个实施方式的一种分析物检测器件的例子;
图2是图1所示分析物检测器件的远端详细图;
图3是图1所示分析物检测器件的截面图;
图4是图1所示分析物检测器件中使用或结合使用的的部件电路示意图;
图5是如图1中所示分析物检测器件中一种活性电极例子的详细视图;
图6是如图5所示活性电极一部分的详细截面图;
图7说明将图1所示分析物检测器件应用于病人的方式例子;
图8是表示通过图1所示器件的电流和活性电极所插入的环境中葡萄糖浓度之间的关系图;
图9说明具有参比电极的如图1所示分析物检测器件的例子;
图10是本发明另一个实施方式的一种分析物检测器件例子;
图11是本发明另一个实施方式用于分析物检测器件的活性电极片的例子;和
图12说明分析物检测器件的另一个例子的截面图,该器件如图1中所示,改进之处包括按本发明另一个实施方式所述的活性电极分配器。
本发明优选实施方式
图1-6说明本发明一个实施方式的一种分析物检测器件100。如图1所示,器件100包括底座部分102,使用了活性电极104和辅助电极,或结合使用的参比电极106(将在下文详述)。这里所用术语“对电极”或“参比电极”包括其组合,这是本领域已知的。底座部分102与外壳108相连,外壳沿器件100的长度方向延伸。底座部分102和外壳108因此作为器件100的基座,在操作中可以握住,将在下文详述。底座部分102可以是固定的,或也可以相对活性电极104的轴可以转动任意角度,可以采用多种方式达到这个目的,例如,用一种弹性材料制造底座部分102,或者提供接头,当辅助电极106基本平行于并紧靠病人皮肤时,活性电极能以小于或等于大约90的角度插入。
如图1-3所示,活性电极104可以位于沿着器件100的轴中心或基本沿着该轴中心。而且,可以是圆形或基本圆形的辅助电极106完全包围着活性电极104。活性电极也可以是能从底座部分102自动或手动伸出来,通过手动或机械装置将活性电极104的至少一部分以相对于其要施加的皮肤表面大于0度到约90度的任意角度插入角质层。辅助电极106可以完全由任何适用的基质材料或者由其组合制成,可以是导电的或不导电的,例如硅,塑料或一种金属,或可以是一种涂覆有导电物质例如金,铂,石墨,钯等,包括金属箔或薄膜的不导电材料,或者是承载在塑料,纸上的金属箔或膜,或者其他易弯曲的材料。辅助电极106可以围绕器件100底座部分102的整个周边,如图1和2所示,或者沿着底座部分102周边的任意适当部分延伸,从而完全或部分环绕着活性电极104。辅助电极106也可以被分隔成若干半圆形或弧形部分。或者,辅助电极106不必是圆形的,可以是方形,矩形,椭圆形等任意适当形状,或者可以是电极的任意适当图案。而且,辅助电极106的结构中可以包含与表面至少一部分相邻的一种导电凝胶物质或任何其他适当的导电材料或器件。辅助电极106的适当形状能保证其与皮肤紧密或牢固地贴合,包括使用本领域已知的胶粘剂。辅助电极106还可以包括研磨表面,能轻微摩擦病人皮肤表面以及角质层,从而产生与病人更好的电接触。而且,辅助电极106的形状能使其象活性电极104一样,最小地介入病人皮肤。
一种器件的例子示于图3中,活性电极104可以与导体110相连,导体110沿器件100的底座部分102和外壳108的中空内部延伸,同时辅助电极106还与导体112相连,导体112也沿器件100的底座部分102和外壳108的中空内部延伸。或者,器件100的底座部分102和外壳108可以是扁平的或是基本扁平放置的敞开结构。导体110或112彼此电绝缘。如图4所示的器件,具有与一个与能产生电压的装置相连的活性电极104和对电极106,能产生电压的装置可以是,例如恒电位器114,和电流检测器116,其目的将在下文详述。
如图5所示,活性电极104可以具有片状部分118和探针部分120。在该例子中,片状部分118可以是方形或基本方形的,宽度是1毫米或大约是1毫米,长度是1毫米或大约是1毫米。探针部分120的长度是约20微米到约5000微米。但是,探针部分120的长度优选较小,例如是约100-2000微米,从而在插入病人皮肤时使介入最小,将在下文详述。另外,探针120的尖端直径较小,例如是100-250微米或更小。而且,活性电极104的形状不必一定如图5所示,可以是针状的,微型手术刀状的,微针状的,或能透过角质层的任何适当形状。
而且,活性电极104是可以替换的,即,使用一次后可以用另一个新的活性电极104进行更换。换言之,活性电极104是可拆除地与导体相连,例如,通过承窝部件(未示出)连接,在使用后,能用手或使用一种装置将活性电极104从器件100上拆卸下来将其舍弃。或者可以在器件100中利用一个顶出工具(未示出)将活性电极104顶出。拆卸或顶出用过的活性电极104后,可以在器件100中插入另一个活性电极104。
而且,如下面将就图11和12所详细讨论的,器件100的结构中可以具有一批活性电极104,可以如图1所示选择其中之一装填至活性位置上,使用后舍弃。同样,辅助电极106是可以重复使用或一次性的。另外,器件100的结构中可以具有可伸缩机构(未示出),能控制用来使活性电极104从器件100的远端伸出,这样,将器件远端按压在病人皮肤上时,活性电极104就能透入病人的角质层,这是本领域技术人员能够理解的。该伸缩机构可以进一步控制,在活性电极104使用后将其缩回器件100远端的开口。或者,该伸缩装置的结构类似一种推出装置,能在活性电极104使用后将其顶出,然后安装新的活性电极104。
图6是图5所示活性电极104中探针部分120的部分截面图。如图所示,探针部分120是由一种基质材料122制成的,例如一种硅基片,不锈钢,塑料,或任何其他适用材料。基质材料122上涂覆有一种导体,例如铂,金,石墨,钯,或任意其他适用材料124。例如,基质材料122可以溅射涂覆以钯,形成导体层124。该材料124的至少一部分上涂覆以一种物质126,例如将含有葡萄糖氧化酶的层126应用在一种固定基质中的导电层124上。例如,葡萄糖氧化酶可以溶解在水相介质中,然后涂在导电层124上,然后将其与戊二醛溶液接触,并干燥。干燥时,葡萄糖氧化酶在基质材料122的表面上发生交联。或者通过旋转涂覆一种酶和一种可UV交联的聚乙烯乙醇改性聚合物的水相溶液来固定酶。然后如图所示将一种干涉膜128应用在葡萄糖氧化酶层126上。葡萄糖氧化酶的固定方法和减少生物液体中电活性物质外部信号的干涉膜是本领域众所周知的。另外,层126中可以包括介体物质,这也是本领域中已知的。
还要注意,活性电极104上可以涂覆有不同种类或组合的酶,例如葡萄糖氧化酶,脱氢酶,乳酸脱氢酶等,并可以使用能进行氧化还原反应的非酶分子识别化学物质,也被称为电化学响应受体,用来检测病人体内不同种类的组分,这都是本领域已知的。还要注意,活性电极104中可以基本上不含任何物质,也不会酶,如参考文献中Jung,S.K.等人所著《分析化学》(AnalyticalChemistry),71:3642-3649(1999);Gorski等人所著《电分析化学杂志》(J.Electroanalytical Chem.),425(1-2):191-199(1997);和Zen等人所著《分析师》(Analyst),125(12):2169-2172(2000)所述。
例如,可以用器件100测量电化学活性组分,例如电解质,氧,一氧化一氮,乳酸,胰岛素,神经传递素,药物,和病人体内的其他分析物,还可测量其他特征,例如病人血液中的pH值,病人体温,病人皮肤的电阻系数等。在活性电极104上发生的反应可以成为对电活性物质,例如氧,一氧化氮等的直接衡量,或者该反应通过上述酶来进行例如葡萄糖氧化酶,葡萄糖脱氢酶的电化学检测,乳酸脱氢酶。术语“分析物”包括病人体内的电化学活性物质以及病人体内物质与层126中物质的电化学活性反应产物或副产物。而且,器件100可以由多种材料制成,例如金属,陶瓷,或塑料,如果有要求的话,器件100中还可以包括如图4中所示的电子线路。另外,器件100可以与任何一种药物传送装置组合成一个整体。药物传送装置包括输液,泵送,透皮,注射,气体辅助颗粒注射,电穿孔,引入液体,颗粒,悬浮液,乳状液,纳米颗粒,胶囊,脂质体等的皮内和皮下注射。另外,器件100可以与任何药物传送装置形成一体,提供对药物,核酸或蛋白质的“闭环”检测和输送。
现在说明器件100的操作。如图7所示,用器件100检测病人体内某一分析物时,将活性电极104和辅助电极106与病人皮肤130表面接触,例如病人手臂的表面接触。用轻微压力或机械装置使活性电极104伸出底座部分102,活性电极104能透过病人皮肤130的角质层,同时辅助电极106停留在病人皮肤130的表面上。要注意的是,由于活性电极104的长度很小,例如是100-2000微米,所以活性电极104仅穿刺进入病人皮肤130的很小深度,减轻或基本消除病人流血的可能,它也不会与病人皮肤130中的神经末梢接触,使病人感觉不适。在另一个实施方式中,许多活性电极104在底座部分102内依次排序,还有要使用的辅助电极106,将用过的活性电极储存起来方便舍弃。采用本领域已知的适用于这种操作的机械方法对这许多电极进行排序。
透过角质层后,活性电极104或与其相邻的物质和组织,或血液或间隙液体中的分析物发生电化学作用,产生一个可检测信号。例如,当该物质是葡萄糖氧化酶而且该分析物是葡萄糖时,当器件100按压在皮肤上时,活性电极100透过角质层至足以接触分析物的深度,发生以下电化学反应:
本领域技术人员能够理解,在上述反应中,不存在介体物质时氧被转变为过氧化氢(H2O2)。可以控制恒电位器114(参见图4)对活性电极104施加一定电势,使活性电极104具有相对于病人皮肤的电势,优选相对于辅助电极106的电势的一个有效电势。有效电势是指该电势能氧化任意或全部电化学活性电解质或物质,例如上述葡萄糖-葡萄糖氧化酶反应生成的过氧化氢,并产生可测量的电流通过器件100,特别是通过活性电极104和辅助电极106之间的病人皮肤130的电流。本领域中已知,有效电势取决于所选用的金属基片124。按照具体应用的要求,有多种方式可以施加有效电势,包括但并不限于渐增的,梯度的,脉冲的,程序脉冲的及它们的组合。
电流大小与病人体内的葡萄糖浓度相关。如图8所示,电流随葡萄糖含量的增加而增大。电流检测器116能检测通过器件100的电流。电流检测器可以与控制器(未示出),例如与微电脑相连,根据如图8所示的图用电流确定病人血液中的葡萄糖含量。检测器的结构是本领域中已知的,能够直接测量电流或电荷或其孤生的参数。
要进一步注意的是,病人皮肤130状态的变化可能影响读数的准确性,因为这种变化会改变电流的值。如上述例子所讨论的,活性电极104必须相对于周围介质,例如病人皮肤在一特定的电势。这个电势通常在约-0.6伏到约+0.6伏范围内,取决于活性电极104处的分析物电化学性质和金属基片124的性质。因为辅助电极106与活性电极104相隔一定距离(例如,达到约1厘米),在将器件100按压在病人皮肤上时,由于这些电极间病人皮肤的电阻系数会导致在活性电极104和辅助电极106之间产生一个电压降(一种“IR”降,即欧姆电阻上的电压降)。而且,由于这个IR降随着状态条件和电极104与106性质不同而变化,所以辅助电极106可能不适合作为施加在活性电极104上电势的参比电势。
因此,如图9中例子所示,器件100可以包括靠近于或与活性电极104或与其相邻的参比电极132,这样,参比电极132就位于活性电极104和辅助电极106之间产生的电场中。这个参比电极132与电源电相连。但是,参比电极可以与活性电极或辅助电极形成一体并与其电绝缘。例如,活性电极104中探针120的尖端部分(参见图5和6)上可以具有仅一面与活性电极相邻或在同一面上面对面排列的参比电极,只要它们是电绝缘的(与活性电极)电绝缘即可。因为参比电极132的位置接近活性电极104,因此,将器件100放置在病人皮肤130上时,在这些电极之间只存在少量病人皮肤,在活性电极104和参比电极132之间由病人皮肤130所产生的是可忽略的IR降。而且,因为这个IR降是可忽略的,所以皮肤状态的变化对这个IR降的大小几乎不产生影响,从而保证在测量时能对活性电极104施加正确的电势。例如,活性电极104的探针部分120(参见图5和6)可以仅在一面上具有葡萄糖氧化酶涂层,另一面上电绝缘的导电涂层能使活性电极104的这个面起到参比电极的作用。
进一步要注意的是可以对上述器件100进行其他变化。例如,器件100可以具有任何适当的形状。如图10所示,该器件可以是圆筒形的,例如器件100-1,可以包括多个活性电极104-1以及一个或更多参比电极132-1,被一个辅助电极106-1所包围。通过使用多个活性电极104-1可以进行许多平行测量,从而增强测量的总信号强度而不会增加病人的疼痛。或者,这些多个活性电极104-1上可以涂覆有不同种类或浓度的上述酶(或根本不含),能同时检测不同种类的上述组分或参数。在这种设计中,各个不同的活性电极104-1都与处理器(未示出)的相应输入偶合,或者以其他方式被处理器辨认,因此处理器能够阐释不同的测量结果。
另外,器件100及其上述变体可以与一种药物或药剂或给药传送设备结合,例如与一种胰岛素传送设备(未示出)结合,能自动给病人传送适当量的胰岛素,纠正病人的血糖含量。换言之,器件100及其变体能与另一种仪器互相通讯,由该仪器产生一个动作或调节仪器的动作。器件100及其变体中可以包含存储器,用来存储器件100获得的读数或由其他仪器提供的信息。而且,器件100及其变体可以象手表或手镯一样是可佩带的,使其作为检测系统连续或基本连续地工作。
活性电极104的探针部分120上还可以涂覆有一种吸附剂涂层,当活性电极104与病人皮肤130中的液体接触时,能立刻获得该液体,从而使其不必在病人皮肤上停留较长时间以读取读数。活性电极104的设计可以是中空腔室的形状,与活性电极相邻的物质例如葡萄糖氧化酶,可以被置于该腔室中。采用这种形状时,腔室中可以有多个开口,使病人皮肤130中的待测组分(例如葡萄糖)能自由而快速地穿透进入腔室。在这种腔室设计中,一些选择性层可以位于开口上或作为器件100上的涂层,防止干扰物质例如抗坏血酸盐,尿酸盐和醋氨酚与活性电极104接触。
如图11所示,多个活性电极104-2可以片105-2上分布,可以将其用于如图12所示器件100-2的另一种构型中。即,器件100-2的结构中包括分配器,用来分配许多活性电极104-2。如图所示,活性电极104-2的卷片105-2可以装入器件100-2中,使器件100-2包含多个能按需被顺序装入的许多活性电极104-2,提供一种能储存用过的微探针使意外伤害最小的一种无菌一次性工具。器件100-2可进一步包括与上述所讨论辅助电极相似的辅助电极106-2。器件100-2可进一步包括电源107-2,在活性电极104-2和辅助电极106-2之间提供电势。
如图所示,活性电极104-2可以与卷片105-2相连,能将电流从电源107-2的阳极导向活性电极104-2。可以揿卷片按钮(未示出)使卷片105-2围绕滑轮109-2转动,将另一个活性电极104-2置于活性位置111-2用以读取读数。器件100-2还包括存储器113-2,用以存储器件100以上述方式读取的读数,还包括用来显示读数的显示器115-2,和用来控制电源107-2,存储器113-2,显示器115-2以及上述所讨论的任何其他部件工作的控制器117-2。器件100-2还包括活性电极伸缩器,其在图12中的数字是119-2,通过对其的控制,可使活性电极104-2伸出上到器件100-2或由其缩回。伸缩器119-2的结构可以进一步在活性电极104-2使用后将其顶出,这是本领域技术人员能够理解的。辅助电极106-2也可以是能类似伸出和缩回的。
还要注意的是,每个活性电极104-2的结构中,都有能作为活性电极的一部分,与该活性电极部分电绝缘的另一部分,作为参比电极,如上述所讨论的参比电极132。在这种设计中,卷片105-2可以被分隔成两个电绝缘区域,与活性电极104-2的活性部分接触,另一个与活性电极104-2的参比电极部分接触。滑轮109-2可以同样被分隔,使分隔的电路导向卷片105-2被分隔的部分,然后导向活性电极104-2的活性和控制部分。因此,控制器115-2能识别流过活性电极104-2的活性和控制部分的电流。
另外,器件100-2可以完成上述就器件100讨论的全部功能,用来检测上述所有组分。而且,器件100-2能与另一种仪器进行通讯,由仪器产生动作或调节仪器的动作。而且,器件100-2象手表或手镯一样可以佩带,从而作为检测系统能连续或基本连续地工作。
虽然上文详细说明了本发明的一些实施方式,但是本领域技术人员能够在不实质性超过本发明的创新和优点的范围内,对实施方式作出多个修改。因此,全部这些改进都被包括在由以下权利要求限定的本发明范围内。
Claims (65)
1.一种用于检测病人体内至少一种分析物的器件,包括:
至少一个活性电极,所述活性电极的长度使所述活性电极适合于透过角质层至足以到达所述分析物的深度,对所述分析物进行电化学检测;
至少一个辅助电极,它至少部分包围所述活性电极,当将该器件按压在所述病人上时,该辅助电极适合于接触病人皮肤。
2.一种如权利要求1所述器件,其特征在于:
所述器件进一步包括底座部分,与所述辅助电极结合成一体;
所述活性电极能伸出所述底座部分至足以接触所述分析物的长度。
3.一种如权利要求2所述器件,其特征在于:
所述活性电极能缩回所述底座部分中。
4.一种如权利要求3所述器件,其特征在于:
所述活性电极能自动伸出所述底座部分并自动缩回到所述底座部分。
5.一种如权利要求3所述器件,其特征在于:
所述活性电极能手动伸出所述底座部分并自动缩回到所述底座部分。
6.一种如权利要求1所述器件,其特征在于:
所述辅助电极具有研磨表面,适合于接触所述病人皮肤。
7.一种如权利要求1所述器件,其特征在于:
所述辅助电极在接触所述病人皮肤时,适合于透过角质层。
8.一种如权利要求1所述器件,其特征在于进一步包括:
数据存储器,适合于储存与所述至少一种分析物或所述病人相关的信息。
9.一种如权利要求1所述器件,其特征在于进一步包含:
通讯装置,适合于在所述器件和外围装置之间交换信息。
10.一种如权利要求1所述器件,其特征在于:
所述器件适合于由所述病人佩带一段时间。
11.一种如权利要求1所述器件,其特征在于:
所述器件进一步适合于检测所述病人的至少一种参数,所述活性电极的长度能使其透过角质层至足以接触组分的深度,对所述参数进行电化学检测;
所述至少一种分析物和所述至少一种参数包括以下至少一种:
电解质,氧,一氧化一氮,乳酸酯,胰岛素,神经传递素,至少一种药物,病人血液中的pH值,病人体温,病人皮肤的电阻系数,葡萄糖氧化酶,葡萄糖脱氢酶和乳酸脱氢酶。
12.一种如权利要求1所述器件,其特征在于进一步包括:
许多所述活性电极。
13.一种如权利要求1所述器件,其特征在于:
所述辅助电极能基本上完全包围所述活性电极。
14.一种如权利要求1所述器件,其特征在于:
所述辅助电极与接近于所述活性电极伸出处所述底座的至少部分表面相连。
15.一种如权利要求1所述器件,其特征在于:
所述活性电极进一步具有施加的电势,从而能对所述分析物进行电化学检测。
16.一种如权利要求1所述器件,其特征在于:
所述分析物是电化学活性的。
17.一种如权利要求1所述器件,其特征在于:
所述分析物选自一氧化一氮,神经传递素,胰岛素,氧。
18.一种如权利要求1所述器件,其特征在于:
所述活性电极由选自锑,钌,铑,铂,钯,石墨,金,及其氧化物的材料制成。
19.一种如权利要求1所述器件,其特征在于进一步包括:
至少一个参比电极,与所述活性电极的距离等于或小于所述活性电极和所述辅助电极任意部分之间的距离,所述参比电极适合于为施加在所述活性电极上的电势提供参比电势。
20.一种如权利要求1所述器件,其特征在于进一步包括:
许多活性电极,其位置适合于以顺序方式使用。
21.一种如权利要求20所述器件,其特征在于:
所述许多活性电极在使用后留在其内部。
22.一种如权利要求1所述器件,其特征在于进一步包括:
一种结合成一体的传送装置。
23.一种如权利要求22所述器件,其特征在于:
所述器件和所述传送装置能互相通讯,控制所述传送装置送至病人体内的物质的给药。
24.一种用来检测病人体内至少一种分析物的器件,包括:
至少一个活性电极,其长度适合于使所述活性电极透过所述病人的角质层至足以接触所述分析物的深度;
至少一种与至少部分所述活性电极相邻的物质,能与至少一种分析物反应,生成至少一种电化学活性产物;
辅助电极,它至少部分包围所述活性电极,当将该器件按压在所述病人身上时,该辅助电极适合于接触所述病人的皮肤。
25.一种如权利要求24所述器件,其特征在于:
所述辅助电极基本上完全包围所述活性电极。
26.一种如权利要求24所述器件,其特征在于:
所述器件进一步包括与所述辅助电极结合成一体的底座部分;
所述活性电极能伸出所述底座部分一定长度,足以接触所述分析物。
27.一种如权利要求26所述器件,其特征在于:
所述活性电极能缩回到所述底座部分中。
28.一种如权利要求27所述器件,其特征在于:
所述活性电极能自动伸出所述底座部分并自动缩回到所述底座部分。
29.一种如权利要求27所述器件,其特征在于:
所述活性电极能手动伸出所述底座部分并自动缩回到所述底座部分。
30.一种如权利要求24所述器件,其特征在于:
所述辅助电极具有研磨表面,适合于接触所述病人皮肤。
31.一种如权利要求24所述器件,其特征在于:
所述辅助电极在接触所述病人皮肤时,适合于透过角质层。
32.一种如权利要求24所述器件,其特征在于进一步包括:
数据存储器,适合于存储与所述至少一种分析物或所述病人相关的信息。
33.一种如权利要求24所述器件,其特征在于进一步包含:
通讯装置,适合于在所述器件和外围装置之间交换信息。
34.一种如权利要求24所述器件,其特征在于:
所述器件适合于由所述病人佩带一段时间。
35.一种如权利要求24所述器件,其特征在于:
所述器件进一步适合于检测所述病人的至少一种参数,所述活性电极的长度能使其透过角质层至足以接触一种组分的深度,能对所述参数进行电化学检测;
所述至少一种分析物和所述至少一种参数包括以下至少一种:
电解质,氧,一氧化一氮,乳酸酯,胰岛素,神经传递素,至少一种药物,病人血液中的pH值,病人体温,病人皮肤的电阻系数,葡萄糖氧化酶,葡萄糖脱氢酶和乳酸脱氢酶。
36.一种如权利要求24所述器件,其特征在于进一步包括:
许多所述活性电极。
37.一种如权利要求24所述器件,其特征在于:
所述辅助电极与接近所述活性电极伸出处所述底座的至少部分表面相连。
38.一种如权利要求24所述器件,其特征在于:
所述活性电极进一步适合于施加上电势,能使所述病人体内的分析物和所述物质之间发生反应,生成至少一种电化学活性产物。
39.一种如权利要求24所述器件,其特征在于进一步包括:
至少一个参比电极,其与所述活性电极的距离等于或小于所述活性电极和所述辅助电极任何部分之间的距离,所述参比电极适合于提供施加在所述活性电极上的电势的参比电势。
40.一种如权利要求24所述器件,其特征在于:
所述物质选自葡萄糖氧化酶,葡萄糖脱氢酶和电化学响应受体物质。
41.一种如权利要求24所述器件,其特征在于进一步包括:
许多活性电极,适合于被排列成能按顺序使用。
42.一种如权利要求41所述器件,其特征在于:
所述许多活性电极在使用后留在其中。
43.一种如权利要求24所述器件,其特征在于进一步包括:
一种结合成一体的传送装置。
44.一种如权利要求22所述器件,其特征在于:
所述器件和所述传送装置适合于互相进行通讯,控制被传送装置送至所述病人体内的物质给药。
45.一种用来检测病人体内一种电化学活性组分的方法,包括:
将器件按压在所述病人的皮肤上,所述器件具有至少一个活性电极,所述活性电极的长度适合于透过所述病人的角质层至足以接触所述分析物的深度,所述器件具有至少一个辅助电极,它至少部分包围所述活性电极,当将所述器件按压在所述病人身上时,所述辅助电极适合于接触所述病人的皮肤;
对所述活性电极施加电势;
测量所述电化学活性组分和所述活性电极发生电化学反应所产生的电流或电荷。
46.一种如权利要求45所述方法,其特征在于
所述测量选自积分电流,电流导数和电荷导数。
47.一种如权利要求45所述方法,其特征在于:
对所述活性电极施加的电势选自渐增的,阶梯性的,脉冲的,程序脉冲的及其组合。
48.一种如权利要求45所述方法,其特征在于所述施加电势的步骤包括:
调节对所述活性电极所施加的相对于所述器件参比电极的电势,其中所述参比电极的距离等于或小于所述活性电极和所述辅助电极任何部分之间的距离。
49.一种如权利要求45所述方法,其特征在于:
所述器件进一步包括与所述辅助电极结合成一体的底座部分;
所述方法进一步包括将所述活性电极伸出所述底座部分至足以接触所述组分的长度。
50.一种如权利要求49所述方法,其特征在于进一步包括:
将所述活性电极缩回所述底座部分中。
51.一种如权利要求50所述方法,其特征在于:
所述活性电极的伸出和缩回是自动完成的。
52.一种如权利要求50所述方法,其特征在于:
所述活性电极的伸出和缩回是手动完成的。
53.一种如权利要求45所述方法,其特征在于:
所述辅助电极具有研磨的表面,适合于接触所述病人的皮肤。
54.一种如权利要求45所述方法,其特征在于:
所述辅助电极在接触所述病人皮肤时适合于透过角质层。
55.一种如权利要求45所述方法,其特征在于进一步包括:
存储与所述组分相关的信息。
56.一种如权利要求45所述方法,其特征在于进一步包括:
在所述器件和一种外围装置之间交换信息。
57.一种如权利要求45所述方法,其特征在于进一步包括:
所述病人将所述器件佩带一段时间。
58.一种如权利要求45所述方法,其特征在于:
所述器件包括许多所述活性电极;
所述方法包括所述许多活性电极的安放,应用和测量步骤。
59.一种如权利要求45所述方法,其特征在于进一步包括:
使所述器件和一种传送装置互相通讯,控制被所述传送装置送入所述病人体内物质的给药。
60.一种如权利要求45所述方法,其特征在于所述组分包括以下一种:
一种电解质,氧,一氧化一氮,乳酸酯,胰岛素,神经传递素,一种药物,病人血液中的pH值,一种指示病人体温的组分,一种指示病人皮肤电阻系数的组分,葡萄糖氧化酶,葡萄糖脱氢酶和乳酸脱氢酶。
61.一种用于检测病人体内一种组分的方法,包括:
将一种器件按压在所述病人皮肤上,所述器件具有至少一个活性电极,所述活性电极的长度适合于透过所述病人的角质层至足以接触所述分析物的深度,所述活性电极具有至少一种与至少部分所述活性电极相邻的物质,能使所述组分与所述物质反应,生成至少一种电化学活性产物,所述器件具有至少一个辅助电极,它至少部分包围所述活性电极,当将该器件按压在所述病人身上时,所述辅助电极适合于接触所述病人的皮肤;
对所述活性电极施加电势;
测量基于所述病人体内的所述电化学活性组分与所述物质反应的电流。
62.一种如权利要求61所述方法,其特征在于
所述测量选自积分电流,电流导数和电荷导数。
63.一种如权利要求61所述方法,其特征在于:
对所述活性电极施加的电势选自渐增的,阶梯性的,脉冲的,程序脉冲的及其组合。
64.一种如权利要求61所述方法,其特征在于所述施加电势的步骤包括:
调节对所述活性电极所施加的相对于所述电极参比电极的电势,其中所述参比电极的距离等于或小于所述活性电极和所述辅助电极任何部分之间的距离。
65.一种如权利要求61所述方法,其特征在于:
所述物质选自葡萄糖氧化酶,葡萄糖脱氢酶和电化学响应受体物质。
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2001
- 2001-12-21 US US10/024,506 patent/US6952604B2/en not_active Expired - Lifetime
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2002
- 2002-12-17 AU AU2002357280A patent/AU2002357280A1/en not_active Abandoned
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- 2002-12-17 CN CNB028255828A patent/CN100391400C/zh not_active Expired - Lifetime
- 2002-12-17 KR KR1020047009792A patent/KR100945901B1/ko active IP Right Grant
- 2002-12-17 JP JP2003555963A patent/JP4373217B2/ja not_active Expired - Fee Related
- 2002-12-17 WO PCT/US2002/040303 patent/WO2003055384A1/en active Application Filing
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2004
- 2004-06-10 ZA ZA2004/04608A patent/ZA200404608B/en unknown
- 2004-08-02 US US10/903,640 patent/US7426408B2/en not_active Expired - Lifetime
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Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN108601562A (zh) * | 2016-02-05 | 2018-09-28 | 传感器健康公司 | 用于血液和/或组织液分析物的测量装置 |
CN109589121A (zh) * | 2019-02-01 | 2019-04-09 | 浙江澍源智能技术有限公司 | 一种探测体内组织液葡萄糖浓度信息的电化学方法及其装置 |
Also Published As
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CA2471430C (en) | 2014-09-09 |
ZA200404608B (en) | 2005-03-30 |
JP2005514088A (ja) | 2005-05-19 |
CN100391400C (zh) | 2008-06-04 |
AU2002357280A1 (en) | 2003-07-15 |
US20050096519A1 (en) | 2005-05-05 |
EP1460932A1 (en) | 2004-09-29 |
CA2471430A1 (en) | 2003-07-10 |
JP4373217B2 (ja) | 2009-11-25 |
ATE514373T1 (de) | 2011-07-15 |
BR0215201A (pt) | 2004-10-13 |
US7426408B2 (en) | 2008-09-16 |
KR20040069190A (ko) | 2004-08-04 |
BR0215201B1 (pt) | 2013-02-05 |
AU2008229839A1 (en) | 2008-10-30 |
AU2008229839B2 (en) | 2011-09-29 |
US6952604B2 (en) | 2005-10-04 |
US20040015063A1 (en) | 2004-01-22 |
EP1460932B1 (en) | 2011-06-29 |
BRPI0215201B8 (pt) | 2021-06-22 |
ES2368559T3 (es) | 2011-11-18 |
WO2003055384A1 (en) | 2003-07-10 |
KR100945901B1 (ko) | 2010-03-05 |
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