CN102307518B - 分析物传感器和用于传感器插入的设备 - Google Patents

分析物传感器和用于传感器插入的设备 Download PDF

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CN102307518B
CN102307518B CN201080006481.7A CN201080006481A CN102307518B CN 102307518 B CN102307518 B CN 102307518B CN 201080006481 A CN201080006481 A CN 201080006481A CN 102307518 B CN102307518 B CN 102307518B
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sensor
analyte
monitoring assembly
analyte monitoring
integrated
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CN102307518A (zh
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克里斯托弗·艾伦·托马斯
乌多·霍斯
贺磊
迈克尔·洛夫
菲利普·伊
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Therasense Inc
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Therasense Inc
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Abstract

本发明提供一种用于在受试者皮肤中插入医疗装置的设备。在一种实施方式中，提供了一种传感器，包括主体部，其具有近端区段、与近端区段纵向对准的远端区段、和中间区段，其中该中间区段从至少远端构件侧向位移并且一间隙被限定在侧向位移的中间区段和远端区段的一部分之间。

Description

分析物传感器和用于传感器插入的设备
相关申请的引用
本申请要求于2009年2月3日提交的美国临时申请61/149,639、于2010年2月1日提交的系列号12/698,124的美国申请和2010年2月1日提交的系列号12/698,129的美国申请的优先权，将其每一个的全部内容通过引用的方式合并入本申请中以用于所有目的。
技术领域
本申请总体涉及一种插入装置，例如涉及在动物如人体内插入分析物传感器和/或灌输套件(infusionset)。
背景技术
糖尿病是一种不可治愈的慢性病，其中身体不产生或者不恰当利用胰岛素。胰岛素是一种由胰腺产生的激素，其调节血糖(葡萄糖)。尤其是，当血糖水平升高，例如在餐后，胰岛素通过促进血糖从血液中移动到体细胞中来降低血糖水平。因此，当胰腺不产生足够的胰岛素(称为1型糖尿病的病症)或者不恰当利用胰岛素(称为2型糖尿病的病症)时，血糖残留在血液中导致高血糖症或异常的高血糖水平。
这种在人们体内血糖水平的巨大的不受控制的波动引起长期严重的并发症。这些并发症中的一些包括失明、肾功能衰竭和神经损伤。另外，已知糖尿病是一种加速心血管疾病如动脉粥样硬化(动脉的硬化)的因素，导致中风、冠状动脉心脏病和其他疾病。因此，在糖尿病管理方面的重要和通用策略是控制血糖水平。
管理血糖水平的一种途径是通过利用常规的体外技术来测试和监测血糖水平，如取血样，将血液施加于测试条，并利用色度法测试仪、电化学法测试仪、或光度法测试仪测试血糖水平。近来其他更多的用于监测血糖水平的技术是通过使用体内葡萄糖监测系统，其连续和自动测试葡萄糖，如例如由AbbottDiabetesCare，Inc.生产的FreeStyle连续葡萄糖监测系统(FreeStyleContinuousGlucoseMonitoringSystem)。与常规的血糖仪不同，连续分析物监测系统采用可插入或可植入传感器，其测定和监控血糖水平。在每次使用新传感器之前，使用者自己将传感器的至少一部分植入在他/他的皮肤下面。典型地，采用插入件组件以将传感器插入使用者的身体内。以这种方式，导引器尖刃部(introducersharp)(同时被接合至传感器)刺一开口进入使用者的皮肤中，使传感器释放并从使用者的身体中移出。因此，对于使用简便(easy-to-use)、简单的插入组件(其可靠、疼痛最小且使用简便)存在需求。
发明内容
本申请提供了多个传感器组件，其包括医疗装置，如分析物传感器(例如葡萄糖传感器)和/或灌输装置(输注装置)，和用以将医疗装置的至少一部分定位在使用者的皮肤表面下方的装置，以及将医疗装置如分析物传感器(例如葡萄糖传感器)和/或灌输装置(输注装置)的至少一部分定位在使用者的皮肤表面下方的方法，和分析物测试的方法。
传感器组件的实施方式包括适于粘附至受试者(主体)的皮肤的基座；耦接至基座的分析物传感器，和具有纵向主体部的插入尖刃部，该纵向主体部包括纵向开口以容纳传感器主体部的至少一部分。
在某些实施方式中，传感器包括主体部，其具有近端区段与远端区段，并且远端区段与近端区段在纵向(或其他方向)上对准。一些传感器实施方式可以包括中间区段。中间区段，如果存在，可以从至少远端构件侧向位移，并且一间隙可以被限定在侧向位移的中间区段和远端区段的一部分之间。在一些实施方式中，传感器被与基座集成以限定为身上装置(on-bodydevice)如单一单元身上装置。第二间隙可以被限定在近端区段和侧向位移的中间区段之间。近端区段可以具有基本上弧形的轮廓(弯曲的外形，curvedprofile)。
在一些实施方式中，传感器主体部的远端区段被容纳在插入尖刃部的在纵向上限定的开口中。间隙可以被限定在远端区段和侧向位移的中间区段之间，其使得远端区段，在一些实质性部分-包括远端区段的整体的实施方式中，被容纳在插入针的纵向开口中。中间区段和近端区段可以与被容纳在插入针中的远端区段邻接。
在一些实施方式中，传感器主体部的近端区段与设置在基座上的导电材料连通(通信，communication)。设置在基座上的导电材料可以限定印刷电路板。传感器的近端区段可以被设置在水平面内，而传感器主体部的远端区段可以被设置在垂直平面内。在一些实施方式中，传感器是经皮(经皮肤的，transcutaneous)传感器。在一些实施方式中，传感器被构造成用于植入在使用者的软组织中。在一些实施方式中，传感器是葡萄糖传感器。
包括传感器组件的实施方式，其包括包含用于与受试者的体液(流体)操作性接触的部分的传感器；限定适于粘附至受试者的皮肤的远端表面并容纳耦接至传感器的电路以用于对传感器执行一功能的基座；以及至少部分设置在基座中的开关，其包括具有从基座的远端表面突出的第一位置和在基座中凹入的第二位置的构件，该构件被构造成当在第二位置时激活电路。
在一些实施方式中，该构件在第一位置被偏置。该构件可以包括设置在基座的开口中的细长构件。在一些实施方式中，当基座与受试者的皮肤接触时，该构件被从第一位置移动至第二位置。在一些实施方式中，粘合剂层被设置在受试者的皮肤上，并且其中当基座与粘合剂层接触时，该构件被从第一位置移动至第二位置。
在一些实施方式中，一旦该构件到达第二位置，开关激活所述电路。在一些实施方式中，只要该构件被保持在第二位置，开关激活电路。在一些实施方式中，传感器是葡萄糖传感器。
在一些实施方式中，电路对传感器施加电势。在一些实施方式中，电路对传感器施加电流。
在一些实施方式中，提供监测器单元，以接收来自传感器/身上单元的信息。例如，将系统构造成用于在身上单元与监测器单元之间进行(有线或无线)通信，例如利用射频通信或其他协议。在两个单元之间的通信可以是有源或无源的。在某些实施方式中，身上单元电路包括用于有线或无线信号传输的通信部件，该信号涉及由传感器监测并(提供)至监测器单元的分析物水平的信号。在某些实施方式中，RFID部件可以被包括在身上单元和监测器单元中，以能够进行RFID通信，其中响应于一个或多个命令或从监测器单元接收的数据通信，身上单元提供数据通信到监测器单元。在一些实施方式中，发射机(传输器)自动，例如连续或在某些实施方式中仅周期性地，如根据预定的时间表，将信号传输至接收器。在某些实施方式中，除自动数据通信之外或代替自动数据通信，身上单元可以仅响应于对于数据的请求，例如接收自监测器单元或者另外由使用者启动的(例如在接收器或身上单元上的开关的激活以启动数据传输)，将信号传输至接收器。在一些实施方式中，提供存储器，并且该电路储存涉及由传感器提供至该存储器的分析物水平的信号。在一些实施方式中，传感器是葡萄糖传感器。
一些实施方式包括用于通过受试者的皮肤插入医疗装置的设备。一种插入设备可以包括限定用于在受试者的皮肤上安置的远端表面的鞘；可相对于鞘在近端位置与远端位置之间移动的操作柄；用于支撑医疗装置并限定通过其的孔的装置支撑件；用于支撑延伸通过该孔的尖刃部并耦接至操作柄的尖刃部支撑件；以及用于偏置操作柄和朝向近端位置的尖刃部支撑件的驱动器。
在一些实施方式中，驱动器包括压缩构件，如压缩弹簧。在一些实施方式中，操作柄至少部分设置在鞘内。在一些实施方式中，操作柄至少部分环绕鞘而设置。在一些实施方式中，提供被设置在操作柄和鞘之间的波纹管部分。
在一些实施方式中，尖刃部支撑件被永久固定至操作柄。在一些实施方式中，装置支撑件被永久附接(affixed)至操作柄。
在一些实施方式中，包括用于将装置支撑件保持在远端位置的挡块部分(stopportion)。在一些实施方式中，装置支撑件被耦接至尖刃部支撑件直到装置支撑件到达远端位置。
在一些实施方式中，当装置支撑件到达远端位置时，装置支撑件与尖刃部支撑件解耦接(不耦接，uncoupled)。在一些实施方式中，当尖刃部支撑件被设置在近端位置时，提供保留构件以将尖刃部支撑件耦接至鞘。
在一些实施方式中，医疗装置是分析物传感器。在一些实施方式中，医疗装置是葡萄糖传感器。在一些实施方式中，医疗装置是灌输套件。
在某些实施方式中，提供用于通过受试者的皮肤插入医疗装置的设备，该设备包括限定用于在受试者的皮肤上安置的远端表面的鞘；可在近端位置与远端位置之间移动的操作柄；用于支撑医疗装置并限定通过其的孔的装置支撑件，该装置支撑件耦接至操作柄；用于支撑延伸通过该孔的尖刃部并耦接至装置支撑件的尖刃部支撑件；以及用于使尖刃部支撑件偏置朝向近端位置的驱动器。
在一些实施方式中，驱动器包括压缩弹簧。在一些实施方式中，操作柄至少部分环绕鞘而设置。
在一些实施方式中，包括用于将装置支撑件保持在远端位置的挡块部分(stopportion)。在一些实施方式中，装置支撑件被耦接至操作柄直到装置支撑件到达远端位置。在一些实施方式中，当装置支撑件到达远端位置时，装置支撑件与尖刃部支撑件解耦接(不耦接，uncoupled)。
提供分析物传感器的实施方式，其包括具有近端区段和远端区段的主体部。远端区段可以与近端区段在纵向上对准。在近端区段和远端区段之间可以包括中间区段，并且在一些实施方式中，中间区段从至少远端构件侧向位移。间隙可以被限定在侧向位移的中间区段和远端区段的一部分之间。
在一些实施方式中，中间区段从传感器主体部的近端区段的至少一部分侧向位移。第二间隙可以被限定在侧向位移的中间区段和传感器主体部的近端区段之间。中间区段可以具有远端和近端，并且进一步近端区段可以与近端区段耦接而远端区段可以与传感器主体部的远端区段耦接。在一些实施方式中，中间区段是杆件(纵向构件，longitudinalmember)。近端可以与被限定在远端构件和中间构件之间的间隙邻接。
在一些实施方式中，近端被容纳在针座(needleseat)内，以形成锚形区(anchorregion)使得传感器主体部滑入在插入尖刃部中限定的开口中以避免传感器主体部不注意从插入针中滑出。在一些实施方式中，传感器主体部的远端区段的宽度使尺寸化以固定在具有直径小于约22至约24号的插入尖刃部的开口内。
在一些实施方式中，中间区段包括平面改变(plane-altering)部分。平面改变部分使得传感器主体部的近端区段处于与传感器主体部的远端区段不同的平面内。在一些实施方式中，近端区段与远端区段处于基本上相互垂直的平面内，例如面积可以限定约120°至约60°，例如约90°的角度。
在一些实施方式中，近端区段具有弧形部分(弯曲部分)。
在一些实施方式中，传感器主体部包括设置在用以限定一个或多个电极的表面中或其上的导电材料。传感器主体部可以包括设置在传感器主体部的表面中或其上的限定迹线的导电材料。这些迹线与一个或多个电极连通(通信)。一个或多个电极可以被设置在传感器主体部的远端区段上。这些迹线和电极的至少之一可以包含金属或碳材料如金、铂、钛和碳。这些迹线和电极的至少之一可以通过材料的烧蚀形成。烧蚀可以包括激光烧蚀。
在一些实施方式中，传感器主体部包括传感层。传感层可以包括酶。传感层可以包括电子传递剂。电子传递剂可以是氧化还原介质。在一些实施方式中，电子传递剂包括锇过渡金属络合物和一种或多种配体。电子传递剂可以被构造成在分析物和工作电极之间间接传递电子。
在一些实施方式中，传感层包括氧化还原聚合物。氧化还原聚合物可以包括锇。传感层可以包括催化剂。催化剂可以包括酶。催化剂可以充当电子传递剂。在一些实施方式中，酶包括葡萄糖氧化酶。在一些实施方式中，酶包括葡萄糖脱氢酶。
在一些实施方式中，传感层可以被构造成使得葡萄糖的反应在酶存在下形成过氧化氢，并且葡萄糖水平可以与过氧化氢的水平相互关联。在一些实施方式中，传感器是皮下传感器。
在阅读了以下更全面描述的具体实施方式的基础上，本发明所披露的主题的这些和其他的特征、目的和优点对于本领域技术人员会变得显而易见。
附图说明
参照简述如下的随附的附图，提供了对本申请中所描述的主题的各种方面、特征和实施方式进行的详细描述。附图是说明性的且不必要画成成比例的，一些部件和特征为了清楚进行了放大。附图示出了本发明主题的各种方面、特征，并以整体或部分解释说明了本发明主题的一种或多种实施方式或实施例。
图1是根据所披露主题的一种实施方式的系统的示意图。
图2是根据所披露主题的一种实施方式的电化学传感器部分剖视截面的视图。
图3是根据所披露主题的另一种实施方式的电化学传感器的视图。
图4是根据所披露主题的图3的电化学传感器的折叠设置的视图。
图5是根据所披露主题的进一步实施方式的电化学传感器的视图。
图6是根据所披露主题的图5的电化学传感器的折叠设置的视图。
图7是根据所披露主题的一种实施方式的身上单元(on-bodyunit)的透视图。
图8是根据所披露主题的图7的身上单元的部分剖视截面的透视图。
图9是根据所披露主题的一种实施方式的系统的示意图。
图10是根据所披露主题的插入件(inserter)的另一种实施方式的剖面透视图。
图11-12是根据所披露主题的图10的插入件的部件的透视图。
图13是根据所披露主题的图10的插入件的部件的截面透视图。
图14是根据所披露主题的图10的插入件的部件的透视图。
图15是根据所披露主题的图14的部件的截面图。
图16-17是根据所披露主题的一种实施方式的针头接口(针榖，needlehub)的示意图。
图18是根据所披露主题的一种实施方式的尖刃部(sharp)的远端视图。
图19是根据所披露主题的一种实施方式的尖刃部(sharp)的侧视图。
图20是根据所披露主题的一种实施方式的尖刃部(sharp)的侧视图。
图21是根据所披露主题的一种实施方式的插入件的分离部分透视图。
图22是根据所披露主题的一种实施方式的插入件的分离部分透视图。
图23是根据所披露主题的一种实施方式的插入件的分离部分放大剖视图。
图24-25是根据所披露主题的图10插入件的部件的透视图。
图26-29是根据所披露主题的图10插入件的剖视图。
图30-31是根据所披露主题的图10插入件的部件的透视图。
图32-33示出了根据所披露主题的实施方式的电源开关机构，包括身上集成传感器和传感器电子器件组件的导电插头。
图34A-36B示出了根据所披露主题的实施方式的电源开关机构，包括身上集成传感器和传感器电子器件组件的导电衬垫。
图37示出了根据所披露的主题实施方式的电源开关机构，包括身上集成传感器和传感器电子器件组件的推动杆致动的内部开关。
图38示出了根据所披露主题的实施方式的电源开关机构，包括身上集成传感器和传感器电子器件组件的导引器收回触发器致动件。
图39示出了根据所披露主题的实施方式的电源开关机构，具有身上集成传感器和传感器电子器件组件的接触开关。
图40-41示出了根据所披露主题的实施方式的电源开关机构，具有身上集成传感器和传感器电子器件组件的电池接触锁定机构。
图42-43示出了根据所披露主题的实施方式的电源开关机构，具有身上集成传感器和传感器电子器件组件的双模穹顶开关。
具体实施方式
这里对公开内容进行详细描述。应当理解，关于以下描述，主题并不限于所描述的具体实施方式，因为主题的具体实施方式当然可以变化。应当理解，本书所使用的技术术语仅是为了描述具体的实施方式，并不是为了限制，因为所披露的主题的范围仅由所附的权利要求限制。
在提供数值范围时，应当理解，该范围或任何其他记述的在上限和下限之间的各中间值或在所记述的范围内的中间值，包含在披露主题的范围内。所记述的每个范围也旨在具体披露所记述范围的各个和每个“子范围(subrange)”。也就是说，比对于一个范围给定的由外上限和外下限明确的外范围小的各个和每个范围，其上限和下限在从所述外下限至所述外上限的范围内(除非文字上明确指明其他范围)，也应理解为包含在所披露主题的范围内，遵从任何特定排除的范围或限制在所记述的范围内。其中范围通过指定上限和下限中的一个或二者来记述，排除这些记述的上下限中的任一个或二者都排除的范围、或包括上下限中的一个或二者都包括的范围也包含在所披露主题的范围内，无论是否在描述范围时使用了或没有使用诸如“从...”、“至”，“贯穿”或“包括”的词语。
除非另外限定，本文所使用的所有特征和科学术语具有如本申请的披露主题所属技术领域普通技术人员所通常理解的相同含义。尽管与本文披露的那些类似或相同的任何方法和材料也可以用于本发明所披露主题的实践和测试，但本申请的披露内容可以具体提及某些示例性方法和材料。
在本申请的披露内容中提及的所有出版物，除非另外指明，均为了所有目的合并于此，包括但不限于披露和描述所引用的出版物相关的材料和方法。
提供本文所讨论的出版物仅在于在本申请的申请日之前它们的披露内容。本文中并不能解释为承认本发明所披露主题因在前的发明而并不在这样的出版物之前。另外，所提供的出版物的日期，可能与实际公开日期不同，其需要独立地确认。
如本文和所附的权利要求中所使用的，除了文字上明确指出外，单数形式“一个”、“一种”和“所述(该，the)”包括复数指代物。
包含在说明书摘要和概要中的内容均不应理解为对公开内容范围的限制。提供说明书摘要和概要是为了著录项目和方便目的，因为其格式和目的应当不是为了理解。
对于本领域技术人员来说显而易见的是，在阅读了本披露内容后，本文所描述和示出的各个单独的实施方式具有离散的部件和特征，其在不背离本发明披露主题的范围或精神的情况下易于与任何其他数种实施方式的特征分离或结合。任何记述的方法可以以所记述的事件的顺序，或以逻辑上可能的任何其他顺序进行。提及单个项目(item)，包括存在多个相同项目的可能性。当两个或多个项目(例如，要素或工序)通过可替换的“或”来提及时，这表明任一个可以单独存在或它们的任何结合可以一起存在，除非一个存在必须排除其他的一个或多个。
系统概述
分析物监测器的某些种类提供为小的、轻型、电池供电和电子控制系统。这样的系统可以构造成使用电化学传感器检测指示体内分析物水平的信号，并收集这样的信号，处理或不处理该信号。在一些实施方式中，进行这种初始处理的该系统的部分可以构造成提供原始的或初始处理的数据至用于进一步收集和/或处理的其他单元。这样的数据提供可以例如通过有线连接(如电连接)或通过无线连接(如IR或RF连接)进行。
某些用于体内测量的分析物监测系统采用传感器，该传感器测量在受试者(主体)的皮肤表面下的组织间液中的分析物水平。它们可以部分地插入穿过皮肤(“经皮(transcutaneous)”)或完全在皮肤下面(“皮下(subcutaneous)”)。在这样的系统中的传感器可以作为电化学电池工作。这样的传感器可以使用任何种类的电极构造，如三电极构造(例如，具有“工作”电极、“参比”电极和“对(counter)”电极(“反”电极))，由受控电势(恒电势)模拟电路驱动，两电极系统构造(例如，仅具有工作电极和对电极)，其可以是自偏压(self-biasing)和/或自供电的，和/或其他构造。在一些实施方式中，传感器可以定位在血管内。
在某些系统中，分析物传感器与传感器控制单元通信。如在本披露内容中使用的，身上单元有时是指分析物传感器与这样的传感器控制单元的这种结合。
某些实施方式是组件式的(模块式的，modular)。身上单元可以作为物理上独立的组件分别提供，并构造成通过至监测器单元的通信链接(通信链路)提供由传感器监测的分析物水平，在本披露内容中是指“接收器单元”或“接收器装置”，或在一些文字中，根据用途，称为“显示单元”、“把柄单元(handheldunit)”或“计量器(meter)”。某些实施方式中，监测器单元可以包括：例如，移动电话装置，个人数字助手，其他用户电子装置如MP3装置、相机、收音机等，或其他能通信的数字处理装置。
监测器单元可以对所接收的分析物数据进行数据处理和/或分析等，以产生关于所监测的分析物水平的信息。监测器单元可以结合有：显示屏，其可以用于例如显示测量的分析物水平，和/或音频部件如扬声器以给使用者(用户)提供可听见的信息，和/或震动装置以给使用者(用户)提供触觉反馈。对分析物监测器的使用者(用户)来说也是有用的是能够看到趋势指示(包括任何正在进行的趋势的幅度和方向)，这样的数据也可以数字地显示，或者通过可视指示器，如可以以可视属性改变的箭头，如大小、形状、颜色、动画、或方向。接收器装置可以进一步结合有体外分析物试验片接口(分析物测试条接口，analyteteststripport)和相关的电子器件以便能够进行离散的(例如血糖)测量。
这些系统的模块化可以改变。在一些实施方式中，传感器是可与传感器控制单元附着的和可从其拆卸的(并且身上单元可以再使用)，而在其他实施方式中，传感器和传感器控制单元可以设置为集成的、不可拆卸的封装件，其可以在使用后抛弃。
图1示出了分析物测量系统10的一种实施方式。在这样的系统中，数据处理单元或传感器控制单元12可以与分析物传感器14相互作用，以获得表示分析物水平的信号。传感器控制单元12可以进一步包括与相关电子器件(未示出)通信的通信电路。在一些实施方式中，传感器控制单元12和传感器可以构造成保持在受试者的“身上”一段时间，可以包括数小时、数天、数周、或一个月或更长。因此，传感器控制单元12和传感器14这里可以统称为身上单元(on-bodyunit)16。还可以设置有接收器单元或监测器单元18。在所示出的实施方式中，传感器控制单元12和监测器单元18经由连接(线路)20(在该实施方式中，无线RF连接)通信。通信可以通过例如RF通信、红外通信、蓝牙通信、紫蜂通信(Zigbeecommunication)、802.1x通信、或WiFi通信等进行。在一些实施方式中，通信可以包括433MHz、13.56MHz或类似的RF频率。在一些实施方式中，可以设置有次监测器单元(副监测器单元)22。数据处理终端24对于提供分析物数据的进一步处理或回顾是有用的。
在某些实施方式中，系统10可以是连续分析物监测器(例如，连续葡萄糖监测系统或CGM)，因此以这种模式工作：其中经由连接20的通信具有足够的范围以支持从身上单元16至监测器单元18的数据流。在一些实施方式中，在CGM系统中的数据流通过身上单元16至监测器单元18而自动提供。例如，对于身上单元16发送数据至监测器单元18可以并不要求使用者(用户)干预。在一些实施方式中，身上单元16周期性提供涉及分析物水平的信号至接收器单元18。例如，可以提供信号，例如，自动发送，以固定时间表，例如，每250ms一次，一秒一次，一分钟一次，等。在一些实施方式中，一旦发生一个事件，例如高血糖事件或低血糖事件等，信号就提供给监测器单元18。在一些实施方式中，数据处理单元12可以进一步包括本地存储器(localmemory)，其中可以记录一段时间采集的“存入数据(loggeddata)”或缓存数据，并时刻(time-to-time)提供一些或全部的积累数据至监测器单元18。或者，设置单独的数据存入单元以获得来自发射机装置(传输器装置)12的周期性传输的数据。在CGM系统中的数据传输可以是单向通信，例如，身上单元16提供数据至监测器单元18，而不从监测器单元18接收信号。在一些实施方式中，在身上单元16和监测器单元18之间提供双向通信。
在一些实施方式中，“应要求”提供信号至监测器单元18。根据这样的实施方式，监测器单元18请求来自身上单元16的信号，或者身上单元16可以一旦激活这么做被激活以发送信号。因此，身上单元16和监测器单元18中的一个或二者都包括可被使用者(用户)激活的开关，或者一旦一些其他动作或事件发生就被激活，这种激活引起分析物相关的信号从身上单元16发送到监测器单元18。例如，监测器单元18紧邻发射机装置12安置并引发数据传送，其或者通过有线连接，或者通过各种方式无线连接，包括例如各种RF载频编码(RFcarriedencoding)和协议以及IR链接。
在一些实施方式中，一旦接收到请求，涉及分析物水平的信号由分析物传感器14瞬时产生，并按所请求的传输至监测器单元18，和/或周期性获得涉及分析物水平的信号，例如，每250ms一次，一秒一次，一分钟一次，等。一旦身上单元16收到“应要求”的请求，则将分析物信号提供给监测器单元。在一些情况下，提供给监测器单元18的信号是或至少包括最近的分析物信号。
在其他实施方式中，“应要求”提供附加数据给监测器单元18。例如，可以提供分析物趋势数据。这样的趋势数据可以包括两个或更多个分析物数据点以指示分析物水平是上升、下降、或稳定。分析物趋势数据可以包括来自长期的数据，如，数分钟、数小时、数天或数周。
关于应要求系统的进一步细节披露于：美国专利号7,620,438，美国专利公开号2009/0054749A1，公开于2009年2月26日；2007/0149873A1，公开于2007年6月28日；2008/0064937A1，公开于2008年3月13日；2008/0071157A1，公开于2008年3月20日；2008/0071158A1，公开于2008年3月20日；2009/0281406A1，公开于2009年11月12日；2008/0058625A1，公开于2008年3月6日；2009/0294277A1，公开于2009年12月3日；2008/0319295A1，公开于2008年12月25日；2008/0319296A1，公开于2008年12月25日；2009/0257911A1，公开于2009年10月15日，2008/0179187A1，公开于2008年7月31日；2007/0149875A1，公开于2007年6月28日；2009/0018425A1，公开于2009年1月15日；以及未决美国专利申请号12/625,524，提交于2009年11月24日；12/625,525，提交于2009年11月24日；12/625,528，提交于2009年11月24日；12/628,201，提交于2009年11月30日；12/628,177，提交于2009年11月30日；12/628,198，提交于2009年11月30日；12/628,203，提交于2009年11月30日；12/628,210，提交于2009年11月30日；12/393,921，提交于2009年2月27日；61/149,639，提交于2009年2月3日；12/495,709，提交于2009年6月30日；61/155,889，提交于2009年2月26日；61/155,891，提交于2009年2月26日；61/155,893，提交于2009年2月26日；61/165,499，提交于2009年3月31日；61/227,967，提交于2009年7月23日；61/163,006，提交于2009年3月23日；12/495,730，提交于2009年6月30日；12/495,712，提交于2009年6月30日；61/238,461，提交于2009年8月31日；61/256,925，提交于2009年10月30日；61/238,494，提交于2009年8月31日；61/238,159，提交于2009年8月29日；61/238,483，提交于2009年8月31日；61/238,581，提交于2009年8月31日；61/247,508，提交于2009年9月30日；61/247,516，提交于2009年9月30日；61/247,514，提交于2009年9月30日；61/247,519，提交于2009年9月30日；61/249,535，提交于2009年10月7日；12/544,061，提交于2009年8月19日；12/625,185，提交于2009年11月24日；12/625,208，提交于2009年11月24日；12/624,767，提交于2009年11月24日；12/242,780，提交于2008年9月30日；12/183,602，提交于2008年7月31日；12/211,014，提交于2008年9月15日；以及12/114,359，提交于2008年5月2日，其每一个均通过引用全文合并于此。
传感器
分析物测量系统10的分析物传感器14可以用于监测各种各样的分析物的水平。可以监测的分析物包括例如乙酰胆碱、淀粉酶、胆红素、胆固醇、绒毛膜促性腺激素(chorionicgonadotropin)、肌酸激酶(例如，CK-MB)、肌酸、DNA、果糖胺、葡萄糖、谷氨酰胺、生长激素、激素、酮类、乳酸盐、过氧化物、前列腺-特异性抗原、凝血酶原、RNA、促甲状腺激素、以及肌钙蛋白。也可以监测药物的浓度，例如，抗生素(例如，庆大霉素、万古霉素，等)，洋地黄毒苷、异羟洋地黄毒苷、滥用的药物、茶碱、华法林(warfarin)。一种或多种分析物可以由给定的传感器监测。
在本发明披露的一些实施方式中，传感器14物理地定位在待监测分析物水平的使用者(用户)的身体内或身体上。传感器14可以被构造成对用户的分析物水平连续取样并将取样的分析物水平，例如葡萄糖浓度，转化成相应的数据信号，例如，电流或电压，用于输入到传感器控制单元电子器件中。可替换地，传感器14可以构造成应要求对分析物水平取样。传感器控制单元电子器件可以放大、过滤或其他处理由传感器提供的信号。
传感器可以采用多种形式。例如，传感器可以包括柔性或刚性基板。在一些实施方式中，传感器可以是线。在一些实施方式中，传感器可以包括两个或三个或更多个电极。
传感器14的一种实施方式示于图2中。在一些实施方式中，传感器14包括基板，其是介电的，例如，聚合物或塑料，如聚酯或聚酰胺。在该实施方式中，传感器构造成使得一部分可定位在皮肤下方，一部分在皮肤上方。因此，传感器14包括插入部分30和接触部分32。接触部分32通常包括几个导电接触部36、38、40(这里示出为3个接触部)用于连接至例如，在数据处理单元12处的其他电子器件。在该实施方式中提供的接触部是用于工作电极36、参比电极38和对电极40的。在一些实施方式中，设置两个或更多个工作电极。这些电极(即，工作电极、参比电极和对电极)的可操作部分(有效部分)(未单独示出)设置在插入部分30的远端。电极的接触(部)和可操作部分通过在基板的表面上延伸的电路迹线42、44和46连接。在一些实施方式中，迹线设置在槽(channel)中，或者可以埋置在基板内，或者可以跨过基板的不同侧。导电接触部、导电迹线、以及电极由导电材料，如铂、钯、金、或导电碳制造。传感器的进一步细节描述于例如美国专利6,175,572；6,103,033中，其通过引用合并于此。
传感器14可以包括近端保留部分48。在一些实施方式中，插入部分30和近端保留部分48基本上为纵向对准的。插入部分30和近端保留部分48被尺寸化和构造成安装有尖刃，用于就位于受试者的皮肤中，如本文所描述的。在使用时，传感器14可以构造成弯曲的(例如沿着线B)，因此定位在两个基本垂直的、交叉的平面内。
如图3所示，传感器14’与传感器14基本相同，许多不同示于图3中并在此注明。传感器14’进一步包括附加特征，其用于连接至与传感器控制单元12相关的外壳(例如安装至外壳或到其中或其上)。例如，传感器14’包括侧向位移部分(横向移位部分，laterallydisplacedportion)(或传感器突出部)50’和纵向位移部分(纵向移位部分，longitudinaldisplacedportion)52’，其提供用于电连接例如导电迹线的路线。传感器14’进一步设置有在近端保留部分48’与纵向位移部分52’之间的缺口54’。这样的构造允许传感器14’弯曲(例如，沿着线B所指示的)，因此可以定位在两个基本垂直的、交叉的平面内，如图4所示。如下所述，传感器突出部50’可以装入数据处理单元12的主体部分，以有助于稳固和定位传感器14’。近端保留部分48’保持其与插入部分30纵向对准，用于定位在插入尖刃部内。
图5示出了根据本披露内容的传感器14”的另一实施方式。传感器14”与传感器14和14’基本相同，一些示例性的不同示于图4D中并在此注明。例如，传感器14”包括接触部分32”，其限定具有弧形边缘的扇状构造。传感器14”限定了传感器标记锯齿状缺口(sensorflagindentation)56”，其也用于辅助保持传感器14”在垂直方向上，如下所述，并提供与数据处理单元12的特征(例如，印刷电路板的底部表面)相配合的分离定位(discretelocation)。传感器14”也能够沿着轴线B弯曲，如图6所示。在本文所描述的传感器的任何实施方式中，插入部分30至保持部分48之间的距离可以是例如约5mm，或约10mm，或约15mm，或约20mm。
通常，通过产生与分析物的氧化还原反应的体积成正比的电流(并指示分析物浓度)，根据本发明的披露的传感器(通过设置具有施加到其上的化学传感层的电极)电化学运行(operate)，其中分析物的氧化还原反应由分析物特异性氧化酶催化。存在这样的实施方式，其中设置以产生并检测这些反应的水平的电极的数量是两个、三个或更多数量。
传感器14(这里其一起指代传感器14’和14”)的一部分可以位于皮肤表面之上，远端部分30穿透皮肤并进入皮下空间与用户的体液如组织间液接触。在所示实施方式中的传感器的配置称为“经皮”。通常，本文所用术语“经皮”是指仅部分地插入到用户的皮肤的一层或多层下方的传感器，而术语“皮下”是指完全插入到用户的皮肤的一层或多层下方的传感器。应当理解，本文所述的许多特征将可以应用到经皮传感器和皮下传感器。关于传感器14的电化学细节提供在美国专利5,264,104、5,356,786、5,262,035、5,320,725、6,990,366中，其每一均通过引用合并于此。
在一些实施方式中，传感器可植入到受试者的身体中一段时间(例如，三到七天，或在一些实施方式中，更长的时间，最多数周)，以接触并监测在体液中存在的分析物。在这方面，传感器能够在各种部位(例如，腹部、上臂、股部，等)设置在受试者中，包括肌肉内、经皮、血管内，或在体腔中。在一种实施方式中，传感器可以是经皮葡萄糖传感器。可替换地，传感器可以是皮下葡萄糖传感器。
在一些实施方式中，传感器14采用插入和/或植入到用户身体中一些使用时间。在这样的实施方式中，基板可以由相对柔性的材料形成以改善用户舒适度并减少对插入部位的周围组织的伤害，例如，通过减少传感器相对于周围组织的相对移动。
尽管在图2-6中所示的实施方式具有三个电极，但是其他实施方式可以包括更少或更多数量的电极。例如，可以使用两电极传感器。传感器可以是外部供电的并允许电流与存在的分析物成比例地通过。可替换地，在一些实施方式中传感器本身可以起电流电源作用。在一些两电极实施方式中，传感器可以是自偏压的，并不需要参比电极。示例性的自供电、两电极传感器描述于美国专利申请12/393,921中，其提交于2009年2月26日，标题“Self-PoweredAnalyteSensor”，为了所有目的通过引用将其全文合并于此。由自供电传感器提供的电路水平可以是低的，例如，在毫微安量级。
身上单元
传感器14(以及传感器14’和14”)的示例性构造以及传感器控制单元12(例如，统称为身上单元16)示于图7-8中。数据处理单元12，可以设置成基本环形的构造，具有减少的高度(即，“Z”-维度)以在当设置在受试者的皮肤上时提供低轮廓。在一些实施方式中，高度为约3mm至约25mm，例如，可以为约4mm，约5mm，约10mm，或约15mm。在某些实施方式中，单元12可以具有可变高度。数据处理单元12，包括其相关的电子器件80，被容纳在传感器外壳122中。例如，电子器件可以包括，例如，用于连接传感器14的模拟接口，处理器，以及电源。可以设置有串行通信部(serialcommunicationsection)。可以包括温度传感器，如热敏电阻检测皮肤和环境温度，以提供对分析物信号的补偿。可以提供RF通信电路以与监测器单元18通信。可以提供数据存储单元以存储短时期例如，几小时或几分钟，或长时期，例如，几天或几周的分析物数据点。附加的可选电子器件包括串行通信部，漏电检测电路，或用户输入装置，例如开关以使一些或所有装置激活/不活动。许多部件可以结合在一起和/或其功能由公共部件提供。另外，某些部件可以完全消除。例如，如果电力由电感耦合提供则电源可以省略。
在一些实施方式中，传感器14设置在数据传输单元12内，例如，以弯曲构造，如本文的某些实施方式所示，例如，在图4和图6中。传感器14的接触部分32可以以基本水平的构造定向，并固定至传输单元12的印刷电路板。将传感器14的插入部分30以基本向下的垂直方向延伸以用于在受试者的皮肤中安置。应当理解，传感器14可以以其他构造设置，例如，以完全基本垂直的构造，等。作为另一种实例，插入部分30可以相对于皮肤表面以斜角设置，例如，在约0°和约90°之间。
如图9所示，身上单元16与监测器单元18通信。这样的通信可以是单向通信，例如从身上单元16到监测器单元18。在一些实施方式中，通信可以是双向的，例如从身上单元16到接受单元18和从接受单元18到身上单元16。在这样的情况下，接受单元18在本文中也称为显示单元、收发器或把柄单元。在身上单元16和监测器单元18之间的通信可以通过RF通信、电感耦合、直接线连接等进行。
插入组件
可以提供插入组件，其用于将医疗装置安装至受试者。在一些实施方式中，插入组件包括插入件和医疗装置本身。插入件可以构造成将各种医疗装置插入到受试者中，例如，分析物传感器、灌输套件(infusionset)、插管或口针(lancet)。在一些实施方式中，插入件可以构造成安装这样的装置的组合，例如，组合的传感器/灌输套件，等。在某些实施方式中，给出的插入件可以构造成在不同的时间安装(就位)第一装置和第二装置。例如，插入件可改造成使用多于一个医疗装置，包括多于一种类型的医疗装置，例如通过连接适配器和/或去除拆卸插入件的一部分。插入件可以经皮将医疗装置就位于受试者的皮肤中，受试者的皮肤之下或穿过受试者的皮肤；或皮下安装；或者安置在皮肤的表面上。医疗装置可以包括特征或结构，例如，倒钩、突出部(tab)、粘合剂，等，以在插入后将装置保持在相对于皮肤的位置上。
在其他实施方式中，插入件组件包括插入件、医疗装置，如分析物传感器，以及至少部分在受试者的皮肤中或皮肤上用于支撑医疗装置的基座(mount)。通过插入件，基座可以同时与医疗装置插入。在其他实施方式中，基座在安装(就位)医疗装置之后或之前安装(就位)。在这样的情况下，基座可以通过插入件施加或单独施加。基座可以包括特征或结构以在插入后将传感器相对于皮肤保持位置。
在其他实施方式中，插入组件包括插入件、分析物传感器、基座、以及电源。基座和电源可以通过插入件与分析物传感器同时插入。在其他实施方式中，基座和电池在安装分析物传感器之后或之前安装。在这样的情况下，基座和/或电源可以通过插入件施加或单独施加。
在另一实施方式中，插入组件包括插入件、医疗装置如分析物传感器、基座以及电子器件。基座和电子器件可以通过插入件与分析物传感器同时插入。在其他实施方式中，基座和电子器件在安装分析物传感器之后或之前安装。例如，基座和分析物传感器可以通过插入件安装，而电子器件可以随后安装。在其他实施方式中，安装基座，然后通过插入件将分析物传感器插入，进一步接着安装传感器。在其他实施方式中，基座和电子器件首先安装，随后安装分析物传感器。
在一些实施方式中，电子器件提供电压或电流至分析物传感器。在一些实施方式中，电子器件处理由分析物传感器提供的信号。在进一步实施方式中，电子器件可以包括通信功能，用于将由分析物传感器提供的信号相关的信号提供给其他部件，如监测器单元，把柄单元、计量器、显示单元、计算机或其他部件。在一些实施方式中，设置有通信电路，如RFID天线或通信电路。
插入件可以包括多个不同的部件。例如，插入件可以包括用于将尖刃部朝向受试者的皮肤推进的一种或多种部件。传感器和相关的电子器件和/或安装结构可以由支撑结构支持，例如支架。可以设置有驱动器用于推进尖刃部和/或分析物传感器/支撑结构。在一些实施方式中，致动器耦连至尖刃部和/或支撑结构，使得由用户施加到致动器上的手动的力(人力)和速度传送至尖刃部和/或支撑结构。
插入件也可以包括一个或多个用于收回(撤回)尖刃部的部件，同时允许分析物传感器和可选的基座和/或电子器件保持到受试者上。用于收回尖刃部的部件可以包括牵引器(retractor)。应当理解，牵引器和致动器可以是相同的结构或包括一些公用部件。在一些实施方式中，牵引器被直接或间接耦连至尖刃部，使得由用户施加的手动的力(人力)从牵引器传送至尖刃部以从皮肤收回尖刃部。在其他实施方式中，可以设置有驱动组件以收回尖刃部。例如，驱动组件可以包括弹簧、发动机、液压活塞等，以从受试者的皮肤收回尖刃部。驱动组件还可以包括线性驱动部件。
在一些实施方式中，一旦由用户致动，牵引器就撤回尖刃部。在这样的情况下，当期望撤回尖刃部时，用户致动牵引器。例如，牵引器可以包括释放开关。一旦致动释放开关，驱动组件，例如，弹簧或其他驱动器，从皮肤收回尖刃部。在其他实施方式中，牵引器和致动器包括公用部件。在致动该致动器以推进尖刃部和分析物传感器之后，用户释放致动器，其允许驱动组件从皮肤撤回尖刃部。
在一些实施方式中，在插入致动后，牵引器撤回尖刃部而无需进一步的用户作用。例如，插入件可以包括这样的特征或部件：一旦尖刃部和支撑结构推进了预定量，其自动收回尖刃部。插入件装置，其在插入后不需要用户进一步的行动，来引发尖刃部的撤回，本文称为使“自动”撤回尖刃部。
插入件装置
根据一种示例性实施方式的插入件100示于图10中。插入件100包括操纵柄102和可移动远端帽104。帽104可以为医疗装置和容纳在其中的尖刃部保持无菌、无污染物环境。如图10、19-20和23-25所示，远端帽104固定于操纵柄102，例如，通过使用一个或多个配合件，例如，螺纹110和111，或勾、胶带(tape)，以及类似物。插入件100包括基部142(base)，基部142限定用于安置在受试者的皮肤S上的远端基本平面的表面112，在其他实施方式中，可以为弧形(弯曲，curved)或倾斜的表面，例如，凹入的或凸起的表面。插入件100可以用于将医疗装置推进到受试者的皮肤中，例如，分析物传感器、灌输套件，等。在一些实施方式中，操纵柄102相对于基部142推进，以将医疗装置推进到患者的皮肤中，在本文将进行更详细的描述。
插入件100的部件示于图11-27中。如图11所示，操纵柄102包括接触表面114，用于用户接触以插入和安装传感器外壳(sensorhousing)122和传感器14。螺纹110设置在操纵柄102上用于经由螺纹111连接至帽104(如图12-13所示)。帽104可以包括冲头125(boss)以辅助尖刃部124的定位。帽104的远端部分包括凹部(recess)115，用于将干燥剂190保持在其中。在一些实施方式中，可以使用硅胶或分子筛。这样的材料可以为颗粒形式(丸粒)或压制成饼块(片状，tablet)。在一些实施方式中，使用硅胶饼块。
帽104设置有一个或多个孔117，其允许空气通过到达干燥剂190，以从插入件100的内部去除水分。帽104包括环形脊部(ridge)113，其与操纵柄102的远端边缘部分116相接合。在一些实施方式中，当帽104连接于操纵柄102时，环形脊部113防止操纵柄102(以及尖刃部124)的移动。
如图10和14所示，基部142包括远端鞘部分192，其在配置(展开，deployment)前遮蔽尖刃部，以及远端轮缘(distalrim)112，其具有基本平的表面构造以靠在受试者的皮肤S上。基部142还包括侧壁191，其与内部围挡件(innerrail)128一起限定用于收回弹簧146的凹部。基部142设置有弹簧底板(springfloor)148，如图29所示。
如图15-16所示，支撑件或穿梭件(shuttle)134支撑针头接口(针榖，needlehub)136，尖刃部124从针头接口(针榖)136在插入件100中纵向延伸。在一些实施方式中，尖刃部相对于皮肤表面以斜角支撑，例如在约0°和约90°之间。针头接口(针榖)136可以通过联锁O形环构造、粘合剂或本领域其他已知技术固定至穿梭件134。在一些实施方式中，尖刃部124是实心针。在一些实施方式中，尖刃部124设置成限定内部孔的基本圆柱形的构造，例如，刚性插管或皮下注射型针。
针头接口(针榖)136进一步示于图17-18中。针头接口(针榖)136支撑尖刃部124，尖刃部124具有尖锐的远端部分160。在一些实施方式中，如本文讨论的，纵向壁开口(opening)或豁口(裂隙，gap)162设置在尖刃部124的壁至少一部分中。豁口162的长度N选定为与传感器的插入部分30到近端保留部分48的长度相匹配，或约5mm，或约10mm，或约15mm，或约20mm。尖刃部124的长度L可以为约5mm，或约10mm，或约20mm，约30mm，或约50mm，基于传感器14的插入部分30的所需深度来选择。
尖刃部124的远端部分160更详细地示于图19-21中。如图19所示，在该实施方式中尖刃部124具有基本“C”形或“U”形侧面轮廓，但是可以具有其他构造，例如，基本“V”形的。纵向豁口162设置在尖刃部124的壁中。图20示出了远端部分160设置有倾斜尖端(angledtip)。在一些实施方式中，倾斜尖端可以设置有第一倾斜尖端部分164和第二陡峭倾斜尖端部分166。包括多个边缘和侧面(face)的示例性构造设置有尖刃点以减少刺穿力、对于受试者的创伤以及出血。传感器主体部的远端区段(distalsection)具有的宽度尺寸化为适应插入尖刃部124的槽口(notch)162，插入尖刃部124具有的直径小于约22至24号(gauge)，在某些实施方式中尖刃部是25号。在一些实施方式中，尖刃部124由金属片制作，并折成截面基本为“V”或“U”或“C”形的构造。在一些实施方式中，使用激光来形成壁开口或豁口162。
图22-23示出了传感器外壳相对于针头接口(针榖)136和尖刃部124的位置。如图22所示，尖刃部124穿过在传感器外壳122中的孔168延伸。传感器14的远端部分用尖刃部124定位。如图23进一步所示出的，电子器件80(例如，包含ASIC电子器件的印刷电路板)和传感器座(sensorhub)123定位在传感器外壳122内。设置有电源82，如电池，例如单次使用的一次性电池，或可充电电池。在一些实施方式中，电池的活动工作寿命可以延长传感器14的活动工作寿命。
图24示出了截面图中传感器外壳122相对于插入件100的尖刃部124的方位。如本文讨论的，传感器14以基本弯曲的构造布置，使得传感器的一部分，例如插入部分30和近端保留部分48基本垂直(例如，基本对准插入件100的纵轴线并且基本垂直于皮肤表面)，接触部分32(示出轮廓)以基本水平的构造定向，并与数据处理单元电子器件如电路80电接触。传感器突出部50能够包封在传感器外壳122的塑料中(例如，“二次塑模(重叠模压，overmolded)”)并固定位置。缺口56给传感器14提供进一步的稳定性，例如，通过允许用传感器外壳122的材料使传感器突出部50包封，并进一步提供在安装期间用于垂直定向传感器14的装置，例如，使得缺口56相对于外壳122的垂直标线(verticallandmark)垂直定位。
安装有传感器外壳122的传感器14设置在支架130中的凹口(concaverecess)内。在插入件100的初始构造中(见，例如，图10和图28-29)，尖刃部124延伸通过支架130中形成的纵向孔168。在一些实施方式中，将孔168适当尺寸化，使得尖刃部124和针头接口(针榖)136均不与支架130接触。因此，一方面针头接口(针榖)136(和尖刃部124)，另一方面支架130和传感器外壳122，同时移动但彼此独立。在其他实施方式中，在孔和尖刃部之间设置摩擦配合。
传感器14的插入部分30和近端保留部分48设置在尖刃部124内的纵向钻孔162内。(见例如，图19)近端保留部分48设置在尖刃部的纵向钻孔内，并给在尖刃部124内的传感器14的安装提供附加的稳定性。尖刃部124的纵向壁豁口或开口162与传感器14对准，使得突出部50和接触部分32从尖刃部124侧向向外延伸。
继续参照图15和16，穿梭件134包括翼状部182和回弹远端延伸指状销(resilientdistally-extendingfinger)184。内部围挡件128示于图25中。如图26所示，穿梭件134被尺寸化和构造成用于在内部围挡件128内可滑动移动。穿梭件134的翼状部182构造成用于在内部围挡件128的轴向槽口(axialnotch)188内可滑动移动。当穿梭件134的指状销184设置在它们的正常偏置向外位置时，指状销184接合内部围挡件128的下表面194。在图26所示的构造中，穿梭件134相对于内部围挡件128锁定。如本文将要讨论的，指状销184可以向内径向偏置以允许穿梭件134相对于内部围挡件128向上运动。
如图10所示，内部围挡件128包括用于接合操纵柄102的上表面186。在一些实施方式中，表面186粘附或其他方式固定至操纵柄102。
内部围挡件128、穿梭件134以及基部142的关系示于图27中。在原始构造中，通过翼状部182和指状销184的接合，内部围挡件128和穿梭件134为锁定关系。内部围挡件128和穿梭件134在基部142内轴向可移动。弹簧146，其固定在基部142的弹簧底板148与穿梭件134的翼状部182之间，沿近端(向上)方向偏置内部围挡件128和穿梭件134。
插入件100在使用前在传感器预配置(predeployment)位置以截面示于图28-29中。通过螺纹110和111的相互接合，帽104连接至插入件100的远端部分。
如图28所示，插入件100包括原始构造，其中操纵柄102相对于基部142设置在近端位置。在这样的构造中，尖刃部124设置在与粘合剂层118的孔空间分开的构造中。
如图30所示，内部围挡件128包括支架130。在传感器插入位置，操纵柄102抵抗弹簧146的偏压向下压下(箭头D)，内部围挡件128同支架130和传感器外壳122向下移动。穿梭件134支撑针头接口(针榖)136，尖刃部124从针头接口(针榖)136处在插入件100内纵向延伸。通过穿梭件134的指状销184与内部围挡件128的远端表面194的相互接合，穿梭件134开始连接至内部围挡件128，而穿梭件134和内部围挡件128二者都一起作为一个单元向远端移动。
随着尖刃部124向远端推进(图30)，其携带传感器14的插入部分30进入受试者皮肤S的皮下部分，并与组织间液接触。随着支架130到达远端位置，传感器外壳122的远端表面接合粘合剂片118的上表面，从而变为粘附到受试者的皮肤表面S。
基部142上的凸缘170接合穿梭件134的指状销184。通过与凸缘170接触，指状销184向内枢转或弯曲(如由箭头F所示)。
如图31所示，指状销184的这种枢转导致指状销184从内部围挡件128的远端边缘194脱离。从而穿梭件134从内部围挡件528脱离。穿梭件134从内部围挡件128脱离使得弹簧张开，从而推动穿梭件134到近端位置，从传感器14和受试者的皮肤S撤回尖刃部134，同时将传感器14留置在皮肤中。一旦尖刃部已经从受试者撤回，其不再可从插入件100的远端部分靠近，这防止意外的针刺。当支架130到达远端位置时，在该远端位置凸缘170接合针穿梭件134的指状销184，针穿梭件134自动撤回针524，而无需用户进一步输入。
在致动集成传感器14和传感器电子器件组件16使用之前，从制造有一段时间组件16可以处于“睡眠”或“空闲”模式。电源如电池集成在组件内，原因包括成本最优化和延长货架期，本发明披露内容的实施方式包括这样的系统：其仅通过传感器14和电子器件单元16定位在皮肤表面而致动，如上所述，即，与施加力至外壳122不同，可以无需用户附加动作。因此，插入传感器14和/或安装外壳122引起电子器件80的激活。在某些实施方式中，激活开关构造包括，可以构造成例如通过插入装置致动而触发的，从而开通集成传感器和传感器电子器件组件进入活动模式。
如图29所示，插入件100也设置有柱塞开关(顶杆开关，plungerswitch)185，其提供数据处理单元12的电子器件80的自动激活。在一些实施方式中，柱塞开关185是设置在传感器外壳122的远端表面上的纵向可滑动件。当传感器外壳向近端推进时，其接合粘合剂片118或可替换地受试者的皮肤表面。一旦这样接合，柱塞开关185相对于外壳122轴向(向近端)移动。例如，在近端位置的柱塞开关示于图30中。这样的轴向移动用于激活传感器电子器件80。在一些实施方式中，柱塞开关是弹簧偏压的。因此，只要传感器外壳抵抗偏压与粘合剂片118保持固定关系，就保持电子器件激活。如果传感器外壳从粘合剂或皮肤移开，因偏压柱塞开关移动，电子器件不活动(不激活)。在其他实施方式中，柱塞开关提供电子器件的一次性激活。在这样的情况下，一旦电子器件激活，传感器外壳不要求保持与粘合剂或皮肤的接触以便保持激活。
如图32-33所示，根据本公开的电源开关机构的实施方式包括身上集成传感器和传感器电子器件组件16的导电插头(conductiveplug)。图32-33示出了传感器外壳122的放大截面图。如所示出的，传感器电子器件组件电路板710设置有物理缺口750，物理缺口750中断在电源(例如电池)与传感器电子器件组件的其他电路之间的电路。
在一种实施方式中，如上所讨论的，当预定的力施加到插入装置100上时，设置在传感器电子器件的外壳122内的导电部分720可以沿箭头730所示的方向移动，使得在电路板上的物理缺口750建立电接触，例如，通过导电部分720与电路板710的导电部分760物理接触。以这种方式，在一种实施方式中，完成了从电源的导电通道并保持传感器电子器件的电路板上的电路，从而给传感器电子器件供电。
作为另一实施例，参照图33，电路板的导电部分760设置在电路板本身上，而导电插头740，例如，当推到空腔750内时，建立电路板的导电部分760之间的点接触。
在一种实施方式中，如上所讨论的，插入装置100致动到位置，传感器和传感器电子器件组件触发如图32-33所示的开关机构，还通过在与导引器移动的方向相对的方向移动导电部分720或导电插头760，从而接通传感器电子器件。在本发明披露的范围内，通过移动导电部分720或导电插头激活传感器电子器件可以包括分开的程序，其中，在将传感器和传感器电子器件组件定位在皮肤表面上之后，预定的力施加到集成传感器14和传感器电子器件组件的外壳上，使得实现导电部分720或导电插头760的所需移动。
图34A-36B示出了根据本发明公开的实施方式的包括身上集成传感器以及传感器电子器件组件的导电衬垫的电源开关机构。参照图34A，暴露的导电环771可以设置和构造成接触传感器外壳122中的电路板的表面(图34B截面所示)，使得插入装置致动件定位在电路板的表面上的导电环771，以便完成传感器外壳122的电接触(例如，通过手动的力(人力)施加到插入装置上使导电环与传感器电子器件的电路板接触)。
参照图35A-B，在另一方面，可以设置有电接触衬垫772、773至传感器外壳122中的电路板(如图35B中截面所示)，使得接触衬垫与导电环771配合，接通传感器电子器件以由其电源提供电力至该器件。图36A-B示出了根据本发明公开的开关致动机构的另一种构造，其中导电环774的一部分选择性定位和设置以建立在传感器外壳122中的电接触(如图36B中的截面所示)。
如所讨论的，各个上述的致动构造包括从电源的电路的中断，使得当装置不使用的时候电源不漏电，一旦致动，在电接触中的断点完整，从而为装置供电并将其激活工作。
图37示出了本发明披露的实施方式的包括身上集成传感器和传感器外壳122的推动杆致动的内部开关的电源开关机构。如所示出的，在一种实施方式中，推动杆810可以设置和定位在传感器电子器件中，使得当力沿如箭头830所示的方向施加时，推动杆810沿相同方向位移，并完成在两个接触部820、821之间的电接触。在一个方面，推动杆810可以设置在密封件840内，如O形环或类似部件。
图39示出了本发明披露的实施方式的电源开关机构，包括身上集成传感器和传感器外壳122的导引器收回触发器致动件。如所示出的，设置有非导电针或装置910以物理上分开的两个电接触部920、921。各个电接触部920、921均被偏置或弹簧负载以朝向彼此接近(urge)，被非导电针910物理上分开。因此，当非导电针910沿如箭头930所示的方向从传感器电子器件组件收回或拔出时，电接触部920、921构造成彼此接触，从而使在电路中的断点完整，并建立点连接以激活传感器电子器件组件。在一个方面，非导电装置或针910可以包括例如，但不限于，玻璃、塑料或任何其他合适的材料以分开两个电接触部并在其间提供绝缘。
图39示出了根据本发明披露的实施方式的电源开关机构，具有身上集成传感器和传感器电子器件组件的接触开关。如图所示，在另一方面，设置有电子开关1001(其构造成从传感器电子器件电源中取出少量的电力)，并且当触发时，通过用致动部件1002使两个接触部1010、1011物理接触，使在接触部1010、1011之间的中断完整，致动部件1002完成传感器电子器件中与其电源如电池的30电路以激活该器件工作。
图40-41示出了根据本发明披露的电源开关机构，具有身上集成传感器和传感器电子器件组件122的电池接触锁定机构。参照图40-41，在另一方面，传感器电子器件的电池接触部可以设置有倒钩突出部(barbedtab)1110。在制造后货架模式(postmanufacturingshelfmode)中，当装置不工作时，突出部1110定位在传感器电子器件外壳内如图40所示位置，使得其不与传感器电子器件电路板的导电接触部1120接触。当如图41所示使用时，突出部1110可以偏置，使得其物理接触在电路板上的导电接触部1120，从而封闭至/来自电池/电源的电路，并因而激活或接通传感器电子器件。如图中所示，突出部1110可以构造成一旦偏置以建立与导电接触部1120的接触，其锁定或锁住导电接触部1120和电路板以便保持电连接。
图42-43示出了根据本发明披露的实施方式的电源开关机构，具有身上集成传感器和传感器电子器件组件的双模穹顶开关。而在另一种实施方式中，双模穹顶形开关1210设置在传感器电子器件组件的电路板上，当向下压时(如图42所示)，穹顶形层1210(其可以包括例如薄片金属穹顶)可以构造成保持如图43所示凹入形状，并在接触点1220处有效闭合在电路板上的电路。在一个方面，穹顶形层1210可以构造成分路(shunt)以使在电路板的接触点1220处短路两个或多个电接触部。可替换地，穹顶形层1210可以连接至电路板，使得穹顶形层1210的一端与两个或多个开路电接触部中的一个接触，穹顶形层1210的压下通过物理接触另一个或多个开路电接触部而闭合在电路板上的电路。
在如上所述的方式中，根据本发明披露的30各种实施方式，如上所述，传感器电子器件激活开关构造设置成可以响应于插入装置的致动而自动或半自动触发或致动(激活)，或者可替换地，可以由用户单独致动(激活)，例如，通过压下外壳的一部分或设置在传感器电子器件的外壳上的开关。因此，可以对传感器电子器件组件进行电力消耗最优化，同时改善使用或激活前装置的制造后货架期。
应当理解本文描述的主题并不限于所描述的具体实施方式，当然可以变化。也应当理解，本文中所使用的术语仅仅是为了描述具体的实施方式，并不是为了限制，因为本发明主题的范围仅由所附的权利要求限制。
所披露主题的实施方式的其他详细描述提供于但不限于：美国专利号7,299,082；美国专利号7,167,818；美国专利号7,041,468；美国专利号6,942,518；美国专利号6,893,545；美国专利号6,881,551；PatentNo.6,773,671；美国专利号6,764,581；美国专利号6,749,740；美国专利号6,746,582；美国专利号6,736,957；美国专利号6,730,200；美国专利号6,676,816；美国专利号6,618,934；美国专利号6,616,819；美国专利号6,600,997；美国专利号6,592,745；美国专利号6,591,125；美国专利号6,560,471；美国专利号6,540,891；美国专利号6,514,718；美国专利号6,514,460；美国专利号6,503,381；美国专利号6,461,496；美国专利号6,377,894；美国专利号6,338,790；美国专利号6,299,757；美国专利号6,299,757；美国专利号6,284,478；美国专利号6,270,455；美国专利号6,175,752；美国专利号6,161,095；美国专利号6,144,837；美国专利号6,143,164；美国专利号6,121,009；美国专利号6,120,676；美国专利号6,071,391；美国专利号5,918,603；美国专利号5,899,855；美国专利号5,822,715；美国专利号5,820,551；美国专利号5,628,890；美国专利号5,601,435；美国专利号5,593,852；美国专利号5,509,410；美国专利号5,320,715；美国专利号5,264,014；美国专利号5,262,305；美国专利号5,262,035；美国专利号4,711,245；美国专利号4,545,382；美国专利申请号2004/0186365，公开于2004年9月23日；美国专利申请号61/238,646，于2009年8月31日提交，将其每一个的披露内容通过引用合并于此。

Claims (20)

1.一种集成组件，包括：
外壳，所述外壳容纳有可拆卸保持的分析物监测组件，所述分析物监测组件包括电源和耦接于分析物传感器的电子器件并且可操作以通信分析物数据，以及通过所述分析物监测组件的所述电子器件而定位的导引器构件；
其中所述分析物监测组件的所述电子器件被配置为在所述外壳内的第一位置与其中所述分析物监测组件的至少一部分所述分析物传感器在皮肤表面下与组织间液接触的第二位置之间移动，并且其中所述分析物监测组件的远端表面被配置为定位在所述皮肤表面上；以及
可操作地连接至所述外壳的偏置装置，配置为将所述导引器构件通过所述电子器件从所述第二位置收回至所述第一位置以被整体保持在所述外壳内。
2.根据权利要求1所述的集成组件，进一步包括端部帽，配置为与所述外壳的开口端配合。
3.根据权利要求1所述的集成组件，其中所述偏置装置被配置为一旦所述导引器构件到达预定的最远端位置，将所述导引器构件自动收回。
4.根据权利要求3所述的集成组件，其中一旦到达所述预定的最远端位置，将所述导引器构件与保留构件脱开。
5.根据权利要求2所述的集成组件，其中所述分析物监测组件被配置为，当所述端部帽与所述外壳的底端接合时，防止在所述第一位置至所述第二位置之间的所述外壳内的位移。
6.根据权利要求1所述的集成组件，包括在所述外壳的远端的外周上提供的粘合剂层。
7.根据权利要求1所述的集成组件，其中所述分析物监测组件包括葡萄糖传感器。
8.根据权利要求1所述的集成组件，其中当所述分析物监测组件被定位于或临近所述第一位置或所述第二位置之一时，所述分析物监测组件的所述电源保持在激活状态。
9.根据权利要求1所述的集成组件，其中在所述第一位置和所述第二位置之间的位移过程中，所述分析物监测组件与在所述外壳中的所述导引器构件的至少一部分接合。
10.根据权利要求1所述的集成组件，其中当所述导引器构件位移至所述第二位置时，所述导引器构件整体保持在所述外壳内。
11.根据权利要求1所述的集成组件，其中所述第一位置包括传感器预配置位置，并且其中所述第二位置包括传感器插入位置。
12.根据权利要求1所述的集成组件，其中所述电子器件包括分析物传感器电子电路，当所述分析物监测组件处于或临近所述第二位置时，将所述分析物传感器电子电路激活。
13.根据权利要求1所述的集成组件，其中在所述第二位置，所述分析物监测组件的一部分被配置为定位在皮肤表面上。
14.根据权利要求13所述的集成组件，其中当所述分析物监测组件的所述部分定位在所述皮肤表面上时，激活所述分析物监测组件。
15.根据权利要求1所述的集成组件，其中在所述第二位置，所述分析物监测组件的至少一部分定位在皮肤层下，以与分析物流体接触。
16.根据权利要求1所述的集成组件，其中所述分析物传感器被配置为在所述第一位置和所述第二位置保持弯曲特性。
17.根据权利要求1所述的集成组件，其中所述一种或多种与分析物的监测水平相关的数据与一个或多个被远程定位的计算设备通信。
18.根据权利要求17所述的集成组件，其中利用RF通信、红外通信、蓝牙通信、紫蜂通信、802.1x通信、或WiFi通信中的一种或多种提供所述一种或多种数据。
19.根据权利要求18所述的集成组件，其中所述一个或多个被远程定位的计算设备包括能够通信的数据处理设备。
20.根据权利要求18所述的集成组件，其中所述一个或多个被远程定位的计算设备包括个人数字助手。
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