CN1217624C - 组合的刺血针和电化学分析物化验设备 - Google Patents

组合的刺血针和电化学分析物化验设备 Download PDF

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CN1217624C
CN1217624C CN018084907A CN01808490A CN1217624C CN 1217624 C CN1217624 C CN 1217624C CN 018084907 A CN018084907 A CN 018084907A CN 01808490 A CN01808490 A CN 01808490A CN 1217624 C CN1217624 C CN 1217624C
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lancet
sample
equipment
end user
skin
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CN1429087A (zh
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P·梅尔曼
J·F·麦克阿勒尔
M·施泰尼
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Diabetes Diagnostics Inc
Inverness Medical Technology Inc
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    • A61B5/1486—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using enzyme electrodes, e.g. with immobilised oxidase
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Abstract

一种用于检测和定量分析血液或间隙液体中可用电化学法检测的分析物质如葡萄糖的设备，包括一个仪表装置、一个刺血针和一个电化学传感器。在这些部件中，该仪表最好是可以重新使用的，而该刺血针和电化学传感器最好包括在组件内而预定一次性使用。该仪表装置有一个外壳、一个连接器和一个显示器，在该外壳中一个刺血针与一机构接合以移动该刺血针，该连接器安置在该外壳内而用于接合一该分析物质专用的电化学传感器并传送一个指示分析物质量的信号，该显示器与该连接器在操作上联接而向使用人显示该分析物质量。该电化学传感器适合于检测一种特定的分析物质。

Description

组合的刺血针和电化学分析物化验设备
发明领域
本申请涉及一种电化学设备，用于检测血液或间隙液体中的分析物质，特别是葡萄糖。
发明背景
葡萄糖监控对糖尿病患者是日常生活的需要，此种监控的精度简直可以说是生死攸关。为了使经常监控葡萄糖水平的需要成为正常生活的一部分，现在可以利用许多葡萄糖测量仪表，它们使患者能以小量血液化验葡萄糖水平。这些仪表中的许多用电化学法检测血样中的葡萄糖，利用作为丢弃式的一次性使用的电极系统的一部分提供的一种酶如葡萄糖氧化酶来检测血液葡萄糖的氧化。这种类型的装置的例子公开在欧洲专利No.0 127 958与美国专利No.5 141868、No.5 286 362、No.5 288 636和No.5 437 999中，它们参考合并于此。
为了使用这些仪表，使用人刺破一个手指或身体其它部分，以产生小量血样或间隙液体试样，然后将它们转移到一次性电极系统上。这可能产生问题，因为一天需要进行几次测量。惯常抽引小量血样的最大缺点是使用目前可用的刺血针或刺指装置时遭受的痛苦。取样的最好部位是指尖皮肤的富毛细血管床，该处易于从小的刺破产生一滴血液。指尖也富有痛觉感受器，当刺破口太深或太接近一个新近的刺破处时，或不够深而需要第二次刺入时，痛苦会增加。如果刺血针缓慢穿刺或缓慢抽回，痛苦也会增加。其次，使用人可能被迫刺破得比需要的更大，以便得到一滴能转移到测量条上的血液。由于这一点，已提出不同的刺血装置设计，这些设计便于使用该装置和限制手续伴随的痛苦。刺血装置的例子描述于美国专利No.4 924 879、No.5 201324、No.5 318 584、No.5 879 311和No.5 879 367中，它们参考合并于此。
国际专利出版物No.WO 95/10223描述了一种采集间隙液体的装置。该装置可以包括一个薄膜，在薄膜上采集和干燥试样。该薄膜然后转移到一个外部装置以供分析。
这些用电化学法监控糖尿病患者的葡萄糖的已知装置每一个都包括一个两步过程，其中首先刺破皮肤获得试样，然后将该试样转移到一个传感器进行分析。这存在几个缺点。首先，使用人必须将血液转移到检测设备中，这需要熟练的测量技巧将手指上的血滴对准传感器或仪表的试样接受孔。其次，由于这种转移，从病人抽取的血液或液体的量可能对传感器不合适，或者太少而不能提供精确的测量，或者太多而增加手续伴随的痛苦。
美国专利No.4 637 403公开一种自包含的装置，用于刺血和利用比色法化验血液葡萄糖。美国专利No.5 054 499公开一种比色装置，其中一个刺血针在刺破皮肤之前先刺破一个吸收部件，后者包括用于比色法检测葡萄糖的试剂。美国专利No.5 682 233和No.5 823973公开一种取样装置，其尺寸能使其与一个进行试样光学分析的化验设备相匹配。美国专利No.5 746 217公开一种刺血针，其中利用一个毛细管捕集试样，在毛细管中用红外光谱法进行分析。美国专利No.5 879 310公开一种装置，其中一个刺血针刺破皮肤，而形成体液试样的试样被转移在一个光学系统内进行分析。
美国专利No.4 953 552公开一种用电化学法检测葡萄糖的装置，其中产生电化学信号的试剂直接涂在刺血针上，因此与试样接触而不需要再一次打扰使用人。在该装置中，没有弹簧作用驱动刺血针，刺血针由使用人简单地压入。这使得刺破操作难于控制。其次，在该公开的装置中替换刺血针和试剂不方便，难于进行传感器的批量生产。
因此，在采集和分析液体试样的方式中留有改进的余地。
发明概要
本发明提供一种改进的设备，用于检测和定量分析血液或间隙液体中可用电化学法检测的分析物质，如葡萄糖。该设备包括一个仪表装置、一个刺血针和一个电化学传感器。在这些部件中，该仪表最好可以重复使用，而刺血针和电化学传感器最好预定一次性使用。
该仪表装置包括一个外壳、安置在该外壳内而用于接合一刺血针和移动被接合的刺血针的机构、一个安置在该外壳内而用于接合一该分析物质专用的电化学传感器并传送一个指示分析物质量的信号的连接器以及一个与该连接器在操作上联接而用于向使用人显示该分析物质。此外，该电化学传感器包括一个摄取血样或间隙液体试样的试样摄取或接受部件。在本发明的一个实施例中，当一个刺血针被接合在该设备中时，接合和移动刺血针的机构将刺血针从初始位置移动到一个刺破使用人皮肤的刺破位置，并任选地返回一个缩回位置，后者可以与初始位置相同或不同。该电化学传感器安置成当刺血针刺破使用人皮肤时试样摄取或接受部件从刺破的皮肤处摄取一个试样。在另一个实施例中，刺血针是一个空心套管，通过它将血液或间隙液体从刺破部位输送到电化学传感器的吸收部分。因此，在任何一个实施例中，本发明都提供一种一步操作的设备，其中，试样的获得和分析是作为将设备压靠使用人皮肤的一步操作的结果而产生的，不需要移动外壳。本发明还提供一种包括一个在其中达到试样获得和分析两者的一步手续的方法。
本发明的另一方面涉及用于本发明所述的仪表中的一次性使用的传感器组件。此种一次性使用的传感器组件可以只包括在一个适合于固定在仪表上的支承件中的传感器，或是包括传感器和刺血针两者。在后一种情况下，该一次性使用的传感器组件可以包括一个传感器和一个或多个刺血针，或者它也可以包括多对刺血针/传感器。
具体地，本发明提出一种用于检测和定量分析血液或间隙液体中用电化学法可检测的分析物质的设备，包括：
多个电化学传感器；
与电化学传感器的数目相同的多个刺血部件；其中所述多个电化学传感器设置在一个盘上；
一个仪表装置，包括一个外壳、安置在该外壳内而用于接合所述多个刺血部件中的一个和移动被接合的刺血部件的机构、一个安置在该外壳内而用于接合一该分析物质专用的所述电化学传感器中的一个并从被接合传感器传送一个指示分析物质量的信号的连接器，以及一个与该连接器在操作上联接而用于向使用人显示该分析物质量的显示器；
其中，所述多个刺血部件在该外壳内被接合；所述电化学传感器包括一个用于摄取血液或间隙液体试样的试样吸收受部件，其中该接合和移动刺血部件的机构在一个周期中移动该刺血部件，从一个初始位置移动到一个刺破使用人皮肤的刺破位置，其中该电化学传感器安置成该接合和移动刺血部件的机构使刺血部件在刺破使用人皮肤之前先刺破所述电化学传感器，该试样吸收部件从刺破的皮肤摄取一个试样而不移动该设备。
该外壳是一个具有顶面和底面的扁平盘，还包括使外壳底面压靠使用人皮肤的机构，其中，电化学传感器安置成邻接该底面，而刺血部件移动而刺破邻接该底面的皮肤。
当该底面压靠使用人皮肤时，使用人可以看到显示器。
还包括一个在操作上连接在该多个刺血部件上的计时器，用于在预定的时间间隔内自动摄取和评价一个试样。
该时间间隔是根据设备所要测定的分析物质量来调整的。
还包括一个试样警报器，用于向使用人指示已经采集到足够的试样。
还包括一个化验警报器，用于向使用人指示已经到采集试样的时间了。
还包括一个结果警报器，用于指示测得的分析物质水平高于或低于预先确定的阈值。
该结果警报器传送一个信号到遥控接收器。
附图简述
图1表示本发明所述设备的外形图；
图2A-2C表示本发明所述装置的截面图；
图3A-3C表示按照本发明的一个实施例的传感器和刺血针的配置的简图；
图3D和3E表示用于本发明的另一实施例中的传感器；
图4表示一种用于分析物质的电化学法检测的示范性传感器组件；
图5A-5C表示包括在本发明所述的传感器组件中的传感器32的特定实施例；
图5D表示本发明所述的传感器组件的又一实施例；
图6A-6C表示本发明的一种替代实施例的简图；
图7表示用于图6所示的本发明实施例中的一种传感器组件的实施例的横截面；
图8A-8G表示本发明的又一实施例；
图9A和9B表示一种具有多个电极部件的传感器的制备；
图9C表示本发明所述的一种设备；
图10表示可以包括在本发明所述设备中的电子线路的简图。
发明详述
本发明的设备是一种整体的刺血和分析装置，它不需要将试样从刺血部位转移到分析条的分开操作。该设备包括一个仪表装置、一个刺血部件(如一个刺血针或空心针)和一个电化学传感器，该仪表装置中安装了分析试样和显示结果的电子线路。电化学传感器包括一个摄取试样用的“试样摄取或接受部件”。如本说明书和权利要求书中使用的，术语“试样摄取或接受部件”包含将液体试样从取样部位直接转移到电化学传感器的各种方法，包括(但不限于)摄取液体的吸收材料如吸水芯、海绵或吸收垫和转移液体用的套管。液体的摄取可以是由吸收材料的结构或者分析盒或套管的尺寸产生的固有的毛细作用或表面张力的结果，或者它也可以是一种由于外加抽吸而激发的主动吸收。事实上，术语“试样摄取或接受部件”应用理解为能将试样从取样部位转移到传感器电极的任何手段。例如，该试样摄取或接受部件可以是传感器本身的活性部分。试样摄取或接受部件的尺寸或摄取体积容量会受待分析试样体积的影响，后者通常为约100μl至10μl。
图1表示本发明所述设备的一个实施例的外形图，但是可以理解，该装置的总体形状是设计选择的问题，因此此处提供的仅是例示。图示的装置便于用一只手握住，同时可以清楚地看到显示器。此外，当从其它部位如手掌、手臂或腹部取样时也便于操作。
如图所示，该装置包括一个其尺寸易于拿在一只手里的外壳1。在外壳1的外表面上有一个使用人能看到的显示器2。皮肤接触环3安置在装置的取样端部4上，而用于启动取样/测定周期的按钮5安置在相对的端部6上。弹射滑片7当其移向取样端部4时弹射所用的刺针和电化学传感器，同时也用于将装置锁住。有选择功能的按钮5用于设定刺血针的刺入深度。
图2A-2C表示图1装置的截面图，显示接合和移动刺血针用的内部机构和将电信号从传感器(图2中未示出)传送到显示器2用的电子线路21。电触头22安置在外壳1的端部附近，用于与传感器形成电接触，并通过导电元件23连接到电子线路上。这三个图例示该装置的操作。
在图2A中，装置处于取样前的停止位置。弹簧20上没有张力。冲杆24连接在刺血针插座8和竖起钮27上。弹簧连接在刺血针上并压在刺血针上，使得能够从竖起位置推出刺血针和从刺入位置拉回刺血针。孔28允许空气从被一个阀26和压靠皮肤接触环3的皮肤所限定的空间中流出。该阀是一个单向阀，它允许空气从该空间流出，而不允许流入。卡口29将竖起钮27保持在位置中，直到手动释放。为了竖起装置，将竖起钮27向上推到卡口29中，使刺血针组件和阀向上移动，压缩弹簧，如图2B中所示。然后对着皮肤按压竖起的装置并离开卡口29。这导致刺血针组件受向下驱动而刺破皮肤，如图2C中所示。在该向下移动中，由于单向阀26，在冲杆24和皮肤之间的区域内压力不会增大。但是，因为弹簧经过了其平衡位置，所以在皮肤被刺破后，刺血针组件有一个向后动作，而这一动作导致该区域中产生减压。
本发明装置的能够进行真正的一步操作的重要特点在于，采用刺血针和传感器的一种配置，使得能够“原位”取样而不必移动设备。图3A-3C表示一个此种配置的简图。图3A表示装置处于待用状态。刺血针31安置在外壳1中，用移动刺血针的机构(未示出)接合。传感器条32是传感器组件33的一部分，后者包括皮肤接触环3和一个将该组件联接到外壳1上的套环34。皮肤接触环3压靠使用人的皮肤，这导致被皮肤接触环环绕的面积中的组织向上突起。当启动装置时，刺血针装置31向下移动，首先刺破传感器32，然后刺破皮肤，如图3B中所示。然后刺血针31退回，而从刺破的皮肤流出的血液或液体吸入传感器(图3C)。传感器可以这样设计，使得刺血针通过一个薄弱的斑点98刺破传感器(见图3D)。该薄弱的斑点是传感器的一个整体部分，它可以是接受试样的摄取机构。
按照本发明的另一实施例，刺血针装置刺破皮肤时不用首先刺破传感器组件。传感器设计成安置在紧靠由该刺破动作获得的试样处，因为将试样传送给传感器成为一步法试样获取和分析过程的一部分，而不需要移动外壳。在这样一个实施例中，传感器与刺血装置相关地安置，因此与试样位置有关，使得试样摄取或接受部件非常接近或能够接触该刺血装置刺破皮肤而形成的试样，使得试样传送到传感器成为可能。该试样摄取或接受部件可以是传感器的一个整体部分，如图3D中所示，或者它也可以是传感器的外面部分，如图3E中所示的吸水芯97。传感器相对于试样的角度可以变化，可以是便于试样高效传送的任何角度。
在图3A-3C所示的本发明实施例中，刺血针31和传感器组件33是分开的。该实施例中使用的刺血针可以是与刺血针移动机构和外壳尺寸相适应的常规设计。在该技术中已知各种形式的刺血针和相关的刺血针移动机构，包括如美国专利No.4 924 879；No.5 196 025；No.5 304 193和No.5 318 583中提到的，它们参考合并于此。传感器组件是一种适用于本发明的新颖部件，它本身构成本发明的一个方面。图4更详细地表示一个示范的用于分析物质电化学法检测的传感器组件的横截面。如图所示，传感器32有一个试剂垫41，安置成与被皮肤接触环3限定的孔42的一个边缘大体对准。套环34有一个凸缘43，当传感器组件连接在该仪表上时，仪表的外壳1压靠该凸缘43。通过凸缘43中的一个孔，可以接触到电触头44和45。可以设置一个绝缘垫，使得只有当存在液体试样时才在试剂垫附近出现触头之间的导电性。当该仪表的外壳1插入传感器组件时，通过电触头44和45形成电接触。
在图4的传感器组件中，传感器32邻近皮肤接触环3安置，并延伸跨过由皮肤接触环限定的开放空间42的一端。传感器包括试剂垫41和响应分析物质的存在而产生一个电化学信号的电极和一个用于吸收置于环的中心孔内的液体并将液体送入试剂的最近反应区的吸附部件，以及一个传送从传感器来的电化学信号用的电触头。该试剂被选定能提供一个响应分析物质的存在的电化学信号。在葡萄糖的情况下，合适的试剂包括一种能使葡萄糖氧化的酶(如葡萄糖氧化酶)和一种介质化合物，该介质化合物将电子从酶转移到当葡萄糖存在时在可测电流中形成的电极。代表性的介质化合物包括铁氰酸盐、茂金属化合物如二茂铁、醌、吩嗪盐、氧化还原指示剂DCPIP和咪唑替代的锇化合物。工作电极已经用这类材料以许多方式配制。例如，导电碳、葡萄糖氧化酶和一种介质的多种混合物已配制成膏体或浓汁并加在垫底上。见EP 0 127 958和US 5 286 362，它们参考合并于此。
图5A-5C表示传感器32的一种特定实施例的组件，包括在本发明所述的传感器组件中。触头53和导线55形成于不导电的衬底51上。在图5A所示的实施例中，形成三组触头和三组导线，以便产生带有试剂52的两个工作电极和一个参比电极。触头和导线用导电的碳素墨汁合适地制成，虽然也可使用其它导电材料。电极可以印刷制成。在一片材料上合适地制成几组传感器，然后切开使用。
衬底51可以用一种强度足够大的材料有利地制成，使得刺血针不能刺穿衬底材料。这可以在刺血针没有对准时防止污染产生。但是，在这种情况下，衬底51需要有一个孔54或一个薄弱的斑点，以便刺血针可以穿过该孔或斑点。用作衬底的合适材料包括聚酯条、高密度聚乙烯和ABS。
在电极制成后，在孔54和电极上包括试剂垫52上放置一层吸水芯56(图5B)。该吸水芯起吸收元件的作用，将试样抽吸到传感器中并将其引导到电极上。合适的吸水芯材料包括尼龙网。但是，在某些情况下，不需要分开的吸水芯，例如当衬垫51中的孔54固有地提供一条通往电极的试剂垫52的毛细通道时。也可以使用聚合物薄膜层来代替吸水芯或与其联用，来限定一条用于将试样吸收到电极上的毛细通道。
在吸水芯(如果存在)和电极上印刷一层绝缘浓汁57。该绝缘浓汁将吸水芯保持在位置上，并限定通过它可以迁移试样的路径。例如，该绝缘浓汁包括一个具有与孔54对准的孔的开口和一个延伸在电极的试剂垫52上面的连接区域。触头53仍然暴露在绝缘浓汁印刷层57的边缘外面，以便与仪表形成接触。任选地，可以加上一个顶盖，以保护反应物质。这样一个顶盖可以用聚合物薄膜如聚酯做成。
图5A-5C的传感器可以与如图4中所示的皮肤接触环和套环装配。图5D表示另一种构型。传感器32支承在皮肤接触环3上。套环534固定在皮肤接触环3的边缘上，其尺寸做成能接受仪表设备的远端535。O形环536在套环534和仪表设备的远端535之间形成密封。仪表设备远端535上的触头522直接与传感器的触头部分(如图5A中的触头53)形成电接触。
图6A和6B表示本发明另一个实施例的简图。在这种情况下，刺血针61是一个安置在传感器62邻近处的空心套管。刺血针61和传感器62可以制造成单个装置，它装入外壳1中以供使用。该外壳最好包括一个皮肤接触环3，该环产生压力将血液或间隙液体移出由刺血针61产生的刺孔。当装置启动时，刺血针和传感器作为一个单元装置向下驱动而刺破皮肤(图6B)。试样而后通过刺血针向上抽引到传感器上。在刺破位置中的停留时间足够长，以使足够的试样引入传感器。或者是，刺血针的移动可以只沿一个方向，当采集到足够的试样时，整个装置移开。如下面更详细地讨论的，后一选择可以便于使用一种当采集到足够试样时向使用人发出声音或其它信号的装置。
图6C表示本发明的一种包括图6A和6B中所示类型的传感器组件的设备。在该设备中，传感器62有一个整体的刺血针61，并可以滑动地容纳在一个第一外壳部分67中。第一外壳部分67的远端3压靠使用人的皮肤，造成弹簧66的压缩和刺血针的露出，以刺破使用人的皮肤。当设备从皮肤移开时，弹簧66使第一外壳部分67向外移动，从而重新屏蔽刺血针的端部。传感器62与触头22产生电接触，后者通过连接器23又与电子线路21产生电接触。一个真空冲杆24安置在第二外壳部分68中，以产生引入血液或液体的抽吸。
图7表示用于图6所示本发明实施例中的传感器组件的一个实施例的横截面。该组件包括一个套管部分71和一个底座部分72。这两个部分可以做成一个连续的材料部件，或者它们可以做成分开的两个部件，例如用胶粘剂结合在一起。一个空心刺血针73通过底座部分72，使得刺血针的空心内部74与传感器75接触。该传感器可以延伸在一个比套管部分大的面积上，如图所示，或者可以利用从套管内表面伸出的一个凸缘来将传感器75保持就位。第二外壳部分68可以压靠该凸缘，或者可以如图7中所示的实施例中那样压靠在围绕套管71的一个环状表面79上。电接触可以通过该环状表面79中的一个孔进行，例如通过触头77、78。触头77、78也可以形成于套管部分的内壁上。传感器75可以具有如图5中所示的同一类型的结构。试剂也可以直接安置在刺血针上，或安置在刺血针空腔中。
图8A-8G表示本发明的又一实施例。该装置可以手动操作(没有自动计时功能)，或者按仪表要求完成化验程序。在后一种情况下，仪表外壳81包含多对刺血针/传感器和一个在预定时间间隔中自动利用这多对刺血针/传感器的计时机构。预定时间间隔的长度与刺血针/传感器对的数目有关，也和化验目标分析物质的所要频度有关。例如，在一个有12对刺血针/传感器的化验血液葡萄糖用的装置中，时间间隔在1至4小时内是合适的。这导致以合理的间隔替换刺血针/传感器，例如一天两次、一天一次或两天一次。计时也可以更短，如每分钟，或可以用逻辑电路选择。这样，例如，在葡萄糖水平快速变化的情形下(如由两次接连的测量之间的差值确定的)，仪表中的逻辑电路可以做成减小后续测量之间的间隔，直到葡萄糖水平稳定的那个时间。仪表也可以做成在短的时间间隔内读取若干初始读数，以便根据结果的变化程度来确定一个合适的基本的化验间隔。该基本的化验间隔可以用于化验周期中所有的后续测量，或如上所述，它可以随葡萄糖水平的变化而缩短。
本发明实施例的其中该外壳包含多对刺血针/传感器的一种合适的形式是图8A和8B中所示的手表型形式。该设备包括外壳81和带子82。外壳有一底面83(示于图8A)和一顶面841(示于图8B)，通过底面83形成刺血针和使用人皮肤之间的接触，而在顶面841上显示化验结果。该装置可以像手表一样围绕使用人手腕用带子卡住，如图8B中所示，或者围绕前臂或上臂卡住。一旦就位，该装置就启动而可以自动进行多次化验，不需使用人再操作，在显示器上显示出多次化验的单个结果或其累加。或者是，该装置或传感器盘可以自动固定(例如使用与皮肤适应的胶粘剂)。这可以用于人体的任何表面上，不再需要带子。
图8C-8F表示本发明该实施例所述设备的部件分解图。最接近设备底面83的是传感器盘84。传感器盘84包括一个衬底810。其上形成多个传感器812。每个传感器包括一个试剂垫814，与一对电极816、818接触。传感器盘84有一个中心孔，允许触发机构(心轴/坡道)通过。传感器作为整体用胶水、超声焊接或用卡扣接头结合在一起。
一个隔离环85安置在传感器盘84上方并与其同轴(图8A)。隔离环85围绕每个传感器812形成一个限定面积，使得接触一个传感器的液体不会与相邻的传感器相互作用。或者是，可以用绝缘印刷或毛细通道形成这种隔离。如图所示，传感器环85具有毂820、轮缘822和多个辐条824。隔离环85安置在传感器盘84的上方，使得一个传感器812安置在相邻的每一对辐条824之间。论轮缘可以包括多个电触头，用于传导从每个传感器对的电极816、818来的指示分析物质量的信号。
一个凸轮环86安置在隔离环85上方并与其同轴(图8E)。该凸轮环有一个坡道部分830，使得当在一个固定位置观察时，凸轮环86的转动导致凸轮环86厚度的增大。凸轮环86有一中心孔，通过该孔插入一个螺钉或类似的紧固件，以装配完成的装置。但是，该孔最好有一个带小平面的或带齿的边缘，以便使凸轮环86能与驱动机构啮合，从而转动该凸轮环。
一个刺血针环87安置在凸轮环86上方并与其同轴。刺血针环87有一轮缘840和多个刺血针辐条842，每个辐条有一个自由中心端部。刺血针环87安置成使得每个刺血针辐条842与隔离环85的辐条824之间的空间对准。刺血针辐条842是用具有显著记忆的可弯曲材料如弹簧钢制成的。刺血针844在刺血针辐条842的中心端部附近连接在每个刺血针辐条842上，方向向下，使得刺血针844的针尖指向传感器盘84。刺血针辐条842的长度使其与在刺血针辐条下面的凸轮环86相互作用。当装置最初装配时，一根刺血针辐条(任意地称为第一刺血针辐条)基本上与坡道部分830的最高部分对准，因此从其中性位置或停止位置向上倾斜。当凸轮环86转动一圈的一部分时，该第一刺血针辐条移开坡道端部并向下弹出，刺穿下面的传感器盘84和使用人皮肤。同时，“第二”刺血针辐条移入坡道部分830的最高部分处的位置，而每根其它刺血针辐条移到一个倾斜增大的位置。因此，凸轮环86的每圈转动的一部分就产生一个取样和测量操作。
图8G表示一个装有图8A-8F所示类型的传感器系统组合件的装配好的装置的横截面。隔离环85装在外壳801的底部上的一个孔内。传感器盘84安置在外壳的外面，其直径大于隔离环85，使得它能与安置在外壳底部上的触头802形成电接触。一个小型电动机如步进电动机与凸轮环86接合，使其与传感器组合件相应地转动，从而顺序地启动与传感器联接的刺血针。电动机803受电子线路804控制，后者也接受从触头802来的信号、处理该信号并传送指令到显示器805，以产生合适的显示。一个小型真空泵806(例如隔膜泵或驱动泵)也安置在外壳801中，以产生一个抽吸力，将试样引入传感器。该泵可以连续运转，或者该泵可以用电子线路控制而在跨越电动机驱动的时间内启动，从而使凸轮环转动。或者是，该真空泵可以在刺血前受驱动，带有充分的压力不足，用作起动刺血周期的信号。
传感器盘84可以与图5A-5C中所示的传感器一样地制造。例如，如图9A和9B中所示，淀积在电极周边的触头91被淀积在衬底92上，每三个一组地沿径向从孔(或薄弱斑点)93向外伸出。每组电极中的一个是参比电极，另两个是工作电极，后者包括适合于产生指示目标分析物质量的信号的试剂。其次，一个网带94加在每个孔93和每组电极上。在网带顶部上形成一个绝缘层95。一旦传感器盘形成，它与其它部件组装而形成完整的装置。
图9C提供此种装置的又一视图，它包括一个在下表面上的皮肤接触环96。皮肤接触环96围绕一个孔97，刺血针98通过该孔刺破使用人的皮肤。该孔97随心轴99的转动而移动，使其接连地与每个电极组对准。在图9C所示的实施例中，当传感器组合件放在一起时，刺血针被心轴预先张紧。心轴99顶部中的槽990。允许对准的刺血针通过心轴落下，以刺破下面的皮肤。组合件的上盒901利用一个O形密封件903密封在底座部分902上。该上盒901和触头91之间通过触头904形成电接触。这使分析电子线路能够位于传感器盘的远处，在那里它们不会有暴露于液体的危险，并可重新使用。由于上盒901与底座部分902密封接合，触头904也转动而在一个时间与一组电极接触。在一种“永久性”附着在皮肤上的装置的情况下，有多少个传感器就有多少个皮肤接触环。只要心轴移动，每次在不同的取样部位就用一个新鲜的刺血针和一个新鲜的传感器进行化验。
图10表示一种可以包括在本发明装置内的电子线路的简图。如图所示，输入信号从传感器和从任何包括的皮肤触头或充分的试样检测器系统提供到信号处理系统中。这些信号通过模拟电路传送到进行数据分析的处理器。该处理器提供一个信号到连接(通过有线或无线连接)在输出显示器上的显示器驱动器。该处理器也可通过有线或无线连接提供一个信号到警报发生器中。该显示器和警报发生器一起构成装置的输出部分。数据分析处理器也与存储装置(如EEPROM)连通，存储装置中可以储存包括校正信息和早先结果的信息。也设置一个计时器，它由数据分析软件启动。该计时器提供功能输出信号，以控制步进电动器(用于转动传感器盘或心轴)和真空发生器(如果有的话)。计时器来的值也可储存在存储器EEPROM中，以备数据分析处理器使用。
上面本发明各种实施例的描述表示各种特点的特定组合。但是，这些描述和组合应当看做仅仅是示范性的，并不排斥替代的实施方案。例如，虽然图示的刺血针环87具有向着环的中心的刺血针自由端部，但可以理解，也可以使用替代的几何构型，其中刺血针环具有星形构型，刺血针自由端部指向外边。同样，刺血针环可以预先张紧，在这种情况下，凸轮环起释放作用而不是产生张力。另一种替代方案是使用一个单独的驱动凸轮或小锤来启动刺血针，当刺血针通过该驱动器的位置转动时，一个对一个地轮流驱动。
本发明的装置可以合并各种附加的特点，它们增强了该装置的特征，并使其更易于使用。例如，这些装置可以包括一个声响警报器或可用其它方式检测的警报器，以警告使用人到了测量时间。在图1所示的装置的情况下，该警报器告诉使用人，他们需要插入一个新的刺血针和传感器(如果还未准备好)并进行测量。在诸如图8或9所示装置的情况下，警报可以实际上先于取样，使得使用人不会因刺血针而吃惊，并知道观看显示器以观测结果。
该装置特别是图1中所示类型的装置，也可以或附加地包括一个声响警报器或可用其它方式检测的警报器，告警使用人已经采集了足够的试样，并可以移去装置。一种声响警报可以采取咔嗒声的形式，由装置内一个卡头的释放而产生，或者可以是装置内用电子方式产生的嘟嘟声。指示获得足够试样的一种方式是假定一个采集足够试样的预定时间。在这种情况下，一个在工作电极之一和参比电极之间或在一对分开的试样监控电极之间的信号的首次出现起动一个计时器，而在某个预定时间(如2秒钟)之后给出试样足够的指示。试样足够也可以利用一对具有空间位置而隔开的电极来确定，使得只有当存在足够的试样时电极之间才可能有一个电信号。在任何一种情况下，被收集的信号可以是任何类型的电子信号，包括根据导电性、电位差或电流(安培计的)的信号。
虽然图1中所示的实施例包括一个皮肤接触环作为帮助从刺破处挤压血液或液体的工具，但该皮肤接触环是任选的，可以用其它部件如由机械泵或电泵产生的吸力来完成同样作用。可以使用一个可变的由使用人选择的真空力来保证皮肤的充分肿胀。一个反馈机构告诉使用人皮肤已与传感器接触。两个由皮肤搭桥的简单触头可以做到这点。在一个使用人产生真空(例如在柱塞上抽引)的设备中，一旦设备已检测到皮肤，使用人受到例如声响或可视信号的警报表示不再需要产生真空。在一种自动设备中，泵机构可以根据该信号而关掉。
该装置可以包括当对分析物质得到反常读数时向使用人提供建议的能力。此种建议可以是试图呼叫医生的形式，或者在适当情况下可以指令使用人给予药物。声响信号可以起低血糖警报的作用，特别在多重化验实施例中。此种装置也可用于过夜监视，警告使用人或其它有关人员(如同伴、父母亲或护士)葡萄糖水平的变化。
本发明的装置提供许多比测量葡萄糖水平的现有装置好的优点。两个优点直接来自于取样和分析功能结合在一个单独的装置中。第一，此种装置只需要使用人完成很少的几步操作。第二，使用人不需操纵一个小电极进入仪表的槽中。这使得可以利用更小的电极，它们(如美国专利申请书No.09/228 855中所述，它参考合并于此)制造费用较低而葡萄糖测量更精确。而且，对于其中存在多对刺血针/传感器的实施例，取样部位可以在一天内自动变换，从而减少了在同一位置重复刺血而造成的伤害。本发明也允许使用极小的试样，它们否则可能难以转移到一个传感器条上。这不仅有利于测量时减轻痛苦，而且还能由于小试样测量伴随的优点而提供更精确的结果。此外，采取由本装置最佳利用的小试样，能减少或消除作为污染试样的废物的处置流出物。

Claims (9)

1.一种用于检测和定量分析血液或间隙液体中用电化学法可检测的分析物质的设备，包括：
多个电化学传感器；
与电化学传感器的数目相同的多个刺血部件；其中所述多个电化学传感器设置在一个盘上；
一个仪表装置，包括一个外壳、安置在该外壳内而用于接合所述多个刺血部件中的一个和移动被接合的刺血部件的机构、一个安置在该外壳内而用于接合一该分析物质专用的所述电化学传感器中的一个并从被接合传感器传送一个指示分析物质量的信号的连接器，以及一个与该连接器在操作上联接而用于向使用人显示该分析物质量的显示器；
其中，所述多个刺血部件在该外壳内被接合；
所述电化学传感器包括一个用于摄取血液或间隙液体试样的试样吸收部件，其中该接合和移动刺血部件的机构在一个周期中移动该刺血部件，从一个初始位置移动到一个刺破使用人皮肤的刺破位置，其中该电化学传感器安置成该接合和移动刺血部件的机构使刺血部件在刺破使用人皮肤之前先刺破所述电化学传感器，该试样吸收部件从刺破的皮肤摄取一个试样而不移动该设备。
2.如权利要求1所述的设备，其特征在于，该外壳是一个具有顶面和底面的扁平盘，还包括使外壳底面压靠使用人皮肤的机构，其中，电化学传感器安置成邻接该底面，而刺血部件移动而刺破邻接该底面的皮肤。
3.如权利要求2所述的设备，其特征在于，当该底面压靠使用人皮肤时，所述显示器为使用人可以看到。
4.如权利要求2所述的设备，其特征在于，还包括一个在操作上连接在该多个刺血部件上的计时器，用于在预定的时间间隔内自动摄取和评价一个试样。
5.如权利要求4所述的设备，其特征在于，该时间间隔是根据设备所要测定的分析物质量来调整的。
6.如权利要求4所述的设备，其特征在于，还包括一个试样警报器，用于向使用人指示已经采集到足够的试样。
7.如权利要求6所述的设备，其特征在于，还包括一个化验警报器，用于向使用人指示已经到采集试样的时间了。
8.如权利要求2所述的设备，其特征在于，还包括一个结果警报器，用于指示测得的分析物质水平高于或低于预先确定的阈值。
9.如权利要求8所述的设备，其特征在于，该结果警报器传送一个信号到遥控接收器。
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