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CN102307517B - 紧凑型在体生理监测装置及其方法 - Google Patents

紧凑型在体生理监测装置及其方法 Download PDF

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Publication number
CN102307517B
CN102307517B CN201080006480.2A CN201080006480A CN102307517B CN 102307517 B CN102307517 B CN 102307517B CN 201080006480 A CN201080006480 A CN 201080006480A CN 102307517 B CN102307517 B CN 102307517B
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sensor
analyte
sheet devices
consideration
data
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CN102307517A (zh
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克里斯托弗·艾伦·托马斯
乌多·霍斯
马丁·J·芬内尔
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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Priority to CN201410525201.3A priority Critical patent/CN104287744B/zh
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Abstract

本发明提供了监测体液中分析物的方法和装置。实施例包括自动地或根据用户请求，连续或离散地从经皮设置的分析物传感器中采集分析物相关数据。本发明的各种电子部件可以与灌封材料一起封装。

Description

紧凑型在体生理监测装置及其方法
本申请要求2009年2月3日提交的题为“Compact On-BodyPhysiological Monitoring Devices and Methods Thereof”的美国临时申请61/149,639、2010年2月1日提交的题为“Compact On-Body PhysiologicalMonitoring Devices and Methods Thereof”的美国专利申请12/698,124，和2010年2月1日提交的题为“Analyte Sensor and Apparatus for Insertion ofthe Sensor”的美国专利申请12/698,129的优先权，它们每个的公开内容都通过引用合并在此。
背景技术
检测某些个体中葡萄糖或其它分析物如乳酸盐、氧等水平对于这些个体的健康极为重要。例如，监测葡萄糖对于患有糖尿病的个体特别重要。糖尿病患者可能需要监测葡萄糖水平，从而确定何时需要胰岛素以降低他们体内的葡萄糖水平，或者何时需要另外的葡萄糖以增加他们体内的葡萄糖水平。
已开发出连续或自动监测体液如血流或间质液中分析物如葡萄糖的装置。其中一些分析物测量装置经配置使得该装置的至少一部分设置在用户皮肤表面下面，例如设置在用户血管或者皮下组织中。
在使用此种佩戴在身体上的经皮或透皮医疗装置期间，它的易于插入和使用性，包括最小的用户干预和在体尺寸和高度(或厚度)，在易用性、耐磨性和舒适性方面是重要的。而且，对于许多需要电池或类似电源执行装置具体操作的此种医疗装置而言，电源管理以及贮存寿命是重要的。
发明内容
本公开的实施例包括提供传感器电子组件的装置和方法及试剂盒，该传感器电子组件包括在感测时间段内监测分析物水平如葡萄糖水平的分析物传感器。感测时间段可由分析物传感器寿命确定，例如，包括但不局限于约3天或更长、约5天或更长，或约7天或更长，或约14天或更长。
实施例包括监测葡萄糖水平和获得葡萄糖测量值的方法、装置和系统，该葡萄糖测量是考虑周到的(discreet)、自动化、侵袭性最小以及疼痛减轻和葡萄糖测试方法重复次数减少，从而在感测时间段内获得多重离散的(discrete)测量。而且，提供了试剂盒。
实施例进一步包括控制单元、耦接到该控制单元上从而接收控制信号和基于载波信号(carrier signal)产生控制命令的控制命令产生器、耦接到控制命令产生器上从而传输用载波信号产生的控制命令和利用该载波信号接收后向散射响应数据包的天线部分，以及耦接到该天线部分从而处理所接收到的后向散射响应数据包和产生输出葡萄糖数据的接收器部分。
实施例也包括如用户需要时，根据需要或根据请求的实时离散葡萄糖测量数据采集，其基于例如RFID数据通信技术用于从分析物传感器/电子组件或在体贴片(patch)装置中进行数据传输和采集，该在体贴片装置包括分析物传感器和数据处理和通信部件，并提供在紧凑型低剖面外壳(lowprofile housing)中且放置在用户皮肤表面上。在某些实施例中，该分析物传感器包括在例如如上所述的感测时间段内，经皮设置并维持在与皮肤表面下间质液流体接触的部分。
在阅读下面更全面描述的本公开详细内容后，本发明的这些和其它特征、目的和优点将变得明显。
附图说明
图1示出数据监测和管理系统，如根据本公开某些实施例的分析物(例如葡萄糖)监测系统；
图2示出本公开一方面中的，用于实时葡萄糖测量数据采集和处理的数据监测和管理系统；
图3是接收器/监测器单元的框图，如根据某些实施例的图1所示的接收器/监测器单元；
图4是阅读器装置/接收器单元的框图，如本公开一方面中的图2所示的阅读器装置/接收器单元；
图5是在体贴片装置的示例示意图，该在体贴片装置包括在本公开一方面的图1和2中的监测系统中使用的集成传感器和传感器电子组件；
图6是在本公开另一方面的图1和2中的监测系统中使用的集成传感器和传感器电子组件的框图；
图7是在根据本公开一方面的图1和2中的监测系统中使用的阅读器装置/接收器单元的示意图；
图8A和8B分别示出在体贴片装置的天线和电子电路部署的顶视图和侧视图，该在体贴片装置包括在本公开一方面的图1和2中的监测系统中使用的传感器和传感器电子组件；
图9示出在体贴片装置的示例电路原理图，该在体贴片装置包括根据本公开多个方面的传感器和传感器电子组件；
图10A是在体贴片装置的部件的透视图，该在体贴片装置包括根据本公开一方面的传感器和传感器电子组件；
图10B是在体贴片装置的部件的另一个透视图，该在体贴片装置包括根据本公开一方面的传感器和传感器电子组件；
图10C是组装的在体贴片装置的另一个透视图，该在体贴片装置包括根据本公开一方面的传感器和传感器电子组件；
图11A～11C示出在体贴片装置中传感器电子组件的电路部署，该在体贴片装置包括根据本公开实施例的传感器和传感器电子组件；
图12A～12B示出用于设置在体贴片装置的插入装置的部署前和插入后配置，该在体贴片装置包括根据本公开的实施例的传感器和传感器电子组件；
图12C～12G示出用于部署在体贴片装置的插入装置在运行时的横断面透视图，该在体贴片装置包括根据本公开的实施例的传感器和传感器电子组件；
图13A～13B示出在体贴片装置的电源开关机构(mechanism)实施例，该电源开关机构包括导电插头，该在体贴片装置包括根据本公开实施例的传感器和传感器电子组件；
图13C～13E示出在体贴片装置的电源开关机构的另一种配置，该电源开关机构包括导电衬垫，该在体贴片装置包括根据本公开实施例的传感器和传感器电子组件；
图14示出在体贴片装置的电源开关机构，该电源开关机构包括利用推杆(push rod)激活的内部开关，该在体贴片装置包括根据本公开实施例的传感器和传感器电子组件；
图15示出在体贴片装置的电源开关机构，该电源开关机构包括导引器回缩(retraction)触发激活器，该在体贴片装置包括根据本公开实施例的传感器和传感器电子组件；
图16示出在体贴片装置的电源开关机构，该电源开关机构带有接触开关，该在体贴片装置包括根据本公开实施例的传感器和传感器电子组件；
图17A～17B示出在体贴片装置的电源开关机构，该电源开关机构带有电池接触锁定机构，该在体贴片装置包括根据本公开实施例的传感器和传感器电子组件；
图18A～18B示出在体贴片装置的电源开关机构，该电源开关机构具有双模态圆顶开关，该在体贴片装置包括根据本公开实施例的传感器和传感器电子组件。
具体实施方式
下列专利、申请和/或出版物都通过引用合并在此：美国专利号4,545,382、4,711,245、5,262,035、5,262,305、5,264,104、5,320,715、5,509,410、5,543,326、5,593,852、5,601,435、5,628,890、5,820,551、5,822,715、5,899,855、5,918,603、6,071,391、6,103,033、6,120,676、6,121,009、6,134,461、6,143,164、6,144,837、6,161,095、6,175,752、6,270,455、6,284,478、6,299,757、6,338,790、6,377,894、6,461,496、6,503,381、6,514,460、6,514,718、6,540,891、6,560,471、6,579,690、6,591,125、6,592,745、6,600,997、6,605,200、6,605,201、6,616,819、6,618,934、6,650,471、6,654,625、6,676,816、6,730,200、6,736,957、6,746,582、.6,749,740、6,764,581、6,773,671、6,881,551、6,893,545、6,932,892、6,932,894、6,942,518、7,167,818和7,299,082，美国公开的申请号2004/0186365、2005/0182306、2007/0056858、2007/0068807、2007/0227911、2007/0233013、2008/0081977、2008/0161666和2009/0054748，美国专利申请号12/131,012、12/242,823，现美国专利号8,219,173；和12/363,712，以及美国临时申请号61/149,639，现美国专利号8,346,335；61/155,889、61/155,891、61/155,893、61/165,499、61/230,686、61/227,967和61/238,461。
在本公开范围内，提供了用于提供紧凑型低剖面的在体生理参数监测装置的装置、系统、试剂盒和方法(生理参数为，例如但不局限于分析物水平、温度水平、心率等)，其被配置成在预定时间段内单次或多次使用，其提供了低剖面几何结构、有效的电能使用、提高的贮存寿命，以及使用的简易性和舒适性，包括装置定位和激活。该实施例包括在体组件，该组件包括经皮设置的分析物传感器和传感器电子设备，其位于紧凑型低剖面集成组件中并耦接到要被使用的插入装置上。
实施例包括连续的葡萄糖监测(CGM)系统或执行操作从而利用经皮设置的分析物传感器连续或半连续地监测分析物水平如葡萄糖水平的例行程序(routine)或功能，其中该实时分析物测量值被提供给数据接收器单元、阅读器装置、数据重发器或中继装置，如在以预定时间间隔或基于编程或可编程的数据传输方案完成数据采样后自动处理数据的数据处理模块、数据处理终端或远程终端。数据处理可以包括显示、存储、执行有关报警或通知功能，和分析如基于例如从传感器/传感器电子组件接收到的所监测的分析物水平生成图表或图。
实施例进一步包括实时采集分析物数据，其中通过经皮设置的分析物传感器检测到的分析物水平永久或临时存储在数据处理单元或集成传感器和数据处理单元组件如在体贴片装置的记忆或存储单元中(存储例如约一天或更短，或约10小时或更短，或约5小时或更短，或约3小时或更短，或约1小时或更短)。在此种实施例中，该接收器单元或阅读器装置可以用来实时，和/或根据需要或根据要求，利用RFID通信协议或其它合适的数据通信协议获得检测到的分析物水平。在某些实施例中，采样分析物相关数据，在用户或患者激活或启动例如开关或其它启动机构从而启动数据转移或提供数据请求命令后通过接收器单元或阅读器装置接收。此种激活开关或机构可以提供或包括在阅读器装置或接收器单元的用户界面中。
本公开的实施例涉及检测体液中至少一种分析物如葡萄糖的方法和装置。实施例包括通过在体贴片装置测量葡萄糖，该在体贴片装置包括透皮设置的与体液如间质液流体接触的分析物传感器，和与分析物传感器信号连通的传感器电子设备，其中该在体贴片装置配置成在阅读器装置或分析物监测系统的接收器单元检测后，在时间段预定接近范围(例如，约10秒或更短，或优选约5秒或更短，或优选约2秒或更短，或在阅读器装置/接收器单元上输出确认信息(confirmation)，如可听通知，表示已从在体贴片装置中成功地采集了分析物相关信号)内传输与所监测分析物水平关联的一个或多个信号或数据包。
例如，在一方面，当阅读器装置/接收器单元设置在与粘接(adhesively)地放置或固定在患者皮肤表面上(其中经皮设置的分析物传感器在皮肤表面下处于流体接触状态，并与该在体贴片装置的传感器电子设备信号通信)的在体贴片装置相距约5英尺或更小(或例如约10英尺或更小)的范围内时，阅读器装置/接收器单元内的无线电频率源配置成为该在体贴片装置提供RF电能。作为回应，一个实施例中的在体贴片装置可以配置成产生输出信号(例如，RF信号)并将它传输到阅读器装置/接收器单元中，其包括尤其是指示葡萄糖测量值的数据。在一方面，在阅读器装置/接收器单元在按需贴片装置的预定接近范围内进行检测后，该信号通信和/或RF电能传输可以自动启动，或者替换地，该阅读器装置/接收器单元可能要求用户激活或确认，然后才启动与如上所讨论的在体贴片装置的信号通信和/或RF电能传输。
在其它方面，从在体贴片装置传输到阅读器装置/接收器单元的数据可以包括自从启动传感器和自从将该在体贴片装置设置成与间质液流体接触或自从数据最后传输到阅读器装置中，或者上面的一个或多个结合以后，存储在该在体贴片装置中预定时间段的葡萄糖趋势信息。例如，趋势信息可以基于从分析物传感器接收到的信号和存储在该在体贴片装置中的信号指示所监测葡萄糖水平在特定时间段内的变化。
如下面进一步详细描述的，该在体贴片装置可以任选地包括输出部件如扬声器、光指示器(例如LED指示器)等，从而提供与其功能关联的一个或多个指示如数据成功传输到阅读器装置或接收器单元的指示、与其内部部件关联的报警或警报状况，或检测从例如阅读器装置或接收器单元接收到的RF电能。通过非限制性实例，一个或多个示例输出指示可以包括可听声音(包括例如，短音调(short tone)、变化的音调(changing tone)、多音调、一种或多种编程铃声或其一种或多种结合)、可视指示如LED指示器的闪烁光、维持预定时间段或编程时间段或可编程时间段(例如，5秒)的LED指示器上的固体光，它们中的每个都可以预先编程到该在体贴片装置中，或者替换地可以在与该在体贴片装置通信时由用户通过阅读器装置/接收器单元的用户界面编程。
在其它的方面，当检测到报警或警报状况(例如，通过分析物传感器监测到所检测的葡萄糖水平在预定可接受范围之外，表明需要注意或药物治疗干预或分析(例如，低血糖状况、高血糖状况、即将发生的高血糖状况或即将发生的低血糖状况))时，该一个或多个输出指示可以在该在体贴片装置中产生并呈现给患者或用户，以便可以及时采取纠正措施。或者，当例如阅读器装置/接收器单元在该在体贴片装置范围内时，该输出指示可以另外地或替换地呈现或输出在该阅读器装置/接收器单元上。
在某些方面，可以基于所得信息如当前分析物水平、分析物水平变化率和分析物趋势信息，预测未来或预期分析物水平。预测性报警编程或可编程在阅读器装置/接收器单元，或在体贴片装置或二者中，并可以配置成在分析物水平达到未来水平之前通知用户可能需要注意的预测分析物水平。这为用户提供了采取纠正措施的机会。
在另外详细描述本公开之前，应当理解，本公开不局限于所描述的特定实施例，当然也可以改变这些实施例。还应当理解，本文使用的术语仅为了描述特定实施例，而不是为了限制，因为本公开范围仅由附属权利要求限定。
如果提供了值范围，应当理解，除非在上下文中明确说明，否则该范围上下限之间的每个中间值均保留到下限单位的十分位，并且任何其它说明的范围或该说明范围中的中间值均包括在本公开中。除非明确排除了所说明范围中的界限值，否则这些较小范围的上下限可以独立地包含在同样涵盖在本公开范围内的这些较小范围中。如果所说明的范围包含上下限中的一个或两个，排除那些所包含的上下限中的一个或两个的范围也包含在本发明公开中。
除非另外定义，否则本文所使用的所有技术和科学术语的含义与本发明所属领域的普通技术人员通常所理解的含义相同。尽管也可以在本公开的实践或测试中使用与本文所述的那些方法和材料类似或等价的任何方法和材料，但是现在说明了优选的方法和材料。本文所提到的所有出版物都通过引用合并于此，从而公开和说明与所引用的出版物有关的方法和/或材料。
必须指出，如在本文和在所附权利要求中所使用的，除非在上下文中明确说明，否则单数形式的“一个”、“一种”和“该”包括复数对象。
本文所讨论的出版物仅指本专利申请提交日期之前公开的出版物。不应将本文中的任何内容视作由于这样的公开先于本发明而不给予本发明公开的授权许可。进一步地，所提供的出版物的日期可能与真实出版物的日期不同，这可能需要单独进行确认。
在阅读本公开后，本领域技术人员将明了，本文所述和所举例说明的单独实施例中的每个均具有离散的部件和特征，在不背离本公开的范围或精神的情况下，它们可以容易地与其它数个实施例中任何一个的特征分离或组合。
本文中所示出的附图不一定是按比例绘制的，为了清楚起见，放大了其中的一些部件和特征。
一般地，本公开的实施例涉及检测至少一种分析物如体液中的葡萄糖的方法与装置。在某些实施例中，本公开涉及利用分析物传感器对分析物水平进行连续和/或自动体内监测。
因此，实施例包括分析物监测装置和系统，该分析物监测装置和系统包括用于分析物如体液中的葡萄糖、乳酸盐等体内检测的分析物传感器，该分析物传感器的至少一部分可设置在用户皮肤下面。实施例包括可完全植入的分析物传感器和其中仅传感器的一部分设置在皮肤下面而传感器的一部分留在皮肤上面的分析物传感器，其中留在皮肤上方的传感器部分用于，例如，与传输器、接收器、收发器(transceiver)、处理器等接触。例如，该传感器可以皮下设置在患者体内以便对患者间质液中的分析物水平进行连续或周期性监测。
出于这种说明的目的，除非另外注明，否则连续监测和周期性监测将可以互换地使用。本文使用的离散监测包括这样采集或接收所监测分析物数据，其中按需或响应于包括传感器和传感器电子设备的在体贴片装置的请求接收或获得实时监测的分析物水平信息。就是说，实施例包括分析物传感器和传感器电子设备，其基于编程的或可编程方案例如每分钟、每5分钟等执行一次分析物相关信息的采样和处理操作。在数据取样和处理时，此种分析物监测例行程序可以实时报告或传输到接收器单元/阅读器装置中。或者，如所讨论的，该连续采样的分析物数据和处理的分析物相关信号可以存储和传输到远程位置如接收器单元、数据处理模块、数据处理终端、阅读器装置或远程终端，以响应于来自远程位置的此种信息请求。可以将分析物水平关联于和/或转化为血液或其它流体中的分析物水平。在某些实施例中，可以设置分析物传感器使其与间质液接触从而检测葡萄糖水平，所检测到的葡萄糖可以用于推断患者血流中的葡萄糖水平。可以将分析物传感器插入到静脉、动脉或含有流体的其他身体部分中。可以配置本公开分析物传感器的实施例以便监测一段时间内的分析物水平，所述一段时间可以是几分钟、几小时、几天、几周或更长的时间。
感兴趣的是如葡萄糖传感器的分析物传感器，所述传感器能够对分析物进行约1小时或更长时间的体内检测，例如，约几小时或更长时间，例如，约几天的更长时间，例如，约三天或更多天，例如，约五天或更长时间，例如，约七天或更长时间，例如，约几周或至少一个月。可以基于所获得的信息，例如，时间t0时的当前分析物水平、分析物的变化率等，来预测未来分析物水平。预测性报警可以在分析物水平达到未来水平之前通知用户可能需要注意的预测分析物水平。这能够为用户提供采取纠正措施的机会。实施例包括(利用例如紧贴低剖面在体贴片装置设置的阅读器装置/接收器单元)传输按用户需要获得的实时分析物信息、存储所获得的实时分析物信息，以及随后基于来自存储装置(如记忆装置)的检索进行的传输。
图1示出数据监测和管理系统，例如，根据本公开某些实施例的分析物(例如，葡萄糖)监测系统。仅为了方便起见，主要就葡萄糖监测装置和系统以及葡萄糖检测方法进一步说明了本公开的实施例，并且此种说明绝不是要限制本公开的范围。应当理解，该分析物监测系统可以配置成在相同或不同时间监测多种分析物。
可以监测的分析物包括，但不限于，乙酰胆碱、淀粉酶、胆红素、胆固醇、绒毛膜促性腺激素、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、和肌钙蛋白。还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、地高辛、滥用的药物、茶碱、和华法林(warfarin)。在监测一种以上的分析物的那些实施例中，可以在相同或不同时间监测分析物。
参考图1，分析物监测系统100包括传感器101、可以与传感器101连接的数据处理单元102(例如，传感器电子设备)、和主接收器单元104，主接收器单元104配置成通过通信链路103与数据处理单元102通信。在本公开的方面，该传感器101和该数据处理单元(传感器电子设备)102可以配置成单一集成组件110。在某些实施例中，该集成传感器和传感器电子组件110可以配置成在体贴片装置。在此种实施例中，该在体贴片装置可以配置成，例如与阅读器装置/接收器单元进行RFID或RF通信。
在某些实施例中，主接收器单元104还可以进一步配置成将数据传输到数据处理终端105从而评价或以另外方式处理或格式化主接收器单元104所接收的数据。数据处理终端105可以配置成通过可以任选地配置成双向通信的通信链路从数据处理单元102直接接收数据。进一步地，数据处理单元102可以包括传输器或收发器，从而将数据传输至主接收器单元104、数据处理终端105或可选的次接收器单元106，和/或从主接收器单元104、数据处理终端105或可选的次接收器单元106接收数据。
图1中还示出了可选的次接收器单元106，其可操作地耦接到通信链路上并且配置成接收从数据处理单元102传输的数据。次接收器单元106可以配置成与主接收器单元104和数据处理终端105通信。次接收器单元106可以配置成与主接收器单元104和数据处理终端105中的每个双向无线通信。如下面进一步详细讨论的，在某些实施例中，与主接收器104相比，次接收器单元106可以是去除特征(de-featured)的接收器，即与主接收器单元104相比，次接收器单元106可以包括有限的或最少数量的功能和特征。这样，次接收器单元106可以包括较小(在一个或多个维度上，包括所有维度)的紧凑外壳或包括在例如，腕表、臂带(arm band)等的装置中。替换地，可以配置具有与主接收器单元104相同或基本类似的功能和特征的次接收器单元106。次接收器单元106可以包括与对接支架单元(docking cradle unit)配合的对接部分，以便安置在例如床侧供夜间监测和/或安置在双向通信装置旁。
在图1所示的分析物监测系统100的实施例中，仅示出了一个传感器101、数据处理单元102和数据处理终端105。然而，本领域普通技术人员将理解，分析物监测系统100可以包括一个以上的传感器101和/或一个以上的数据处理单元102，和/或一个以上的数据处理终端105。可以在患者体内设置多个传感器以便在相同或不同时间对分析物进行监测。在某些实施例中，可以将通过第一设置的传感器获得的分析物信息与通过第二传感器获得的分析物信息进行比较。这对于确认或验证从一个或两个传感器所获得的分析物信息是有用的。如果在关键的相关治疗决策中考虑了分析物信息，那么这类冗余(redundancy)可能是有用的。在某些实施例中，第一传感器可以用于校准第二传感器。
分析物监测系统100可以是连续监测系统，或半连续或离散监测系统。在多部件环境中，每个部件都可以配置成由系统中的一个或多个其它部件唯一地识别，以便可以容易地解决分析物监测系统100中各部件之间的通信冲突。例如，可以使用唯一的ID、信道等。
在某些实施例中，传感器101物理设置在分析物水平正受到监测的用户身体内或身体上。可以配置传感器101从而至少周期性地对用户分析物水平进行采样并将所采集的分析物水平转化为相应信号以便由数据处理单元102传输。
数据处理单元102可耦接到传感器101上，以便两个装置都设置在用户身体内或身体上，其中分析物传感器101的至少一部分经皮设置。数据处理单元102在某些实施例中可以包括传感器101的一部分(与数据处理单元102电通信的传感器近端部分)，该部分用例如灌封材料或其它保护材料封装(encapsulated)在数据处理单元102的应刷电路板内或上。该数据处理单元102执行数据处理功能，其中此种功能可以包括但不局限于对数据信号滤波和编码，其中的每个功能都对应于用户采集的分析物水平，以便通过通信链路103传输给主接收器单元104。在一个实施例中，传感器101或数据处理单元102或结合的传感器/数据处理单元可以全部植入在用户皮肤层下面。
在一方面，主接收器单元104可包括包含RF接收器和配置成通过通信链路103与数据处理单元102通信的天线的模拟接口部件，以及处理从数据处理单元102接收的数据的数据处理部件，如数据解码、误差检测和校正、数据时钟发生、数据位恢复。
在操作中，某些实施例中的主接收器单元104配置成与数据处理单元102同步，从而基于例如数据处理单元102的识别信息唯一地识别数据处理单元102，且然后周期性地接收由数据处理单元102传输的与通过传感器101检测的所监测分析物水平相关的信号。就是说，当通信链路103(例如，RF范围)维持在这些部件之间时，当以CGM模式操作时，某些实施例中的接收器单元104配置成自动地从分析物传感器/传感器电子设备接收时间间隔的分析物相关的数据包。
再参考图1，数据处理终端105可以包括个人计算机、便携式数据处理装置，或诸如膝上型或手持式装置的计算机(如各人数字助理(PDA)、通信装置如便携式电话(如多媒体和可上网移动电话，如iPhone、黑莓(Blackberry)装置、Palm装置如Palm Pre、Treo或类似电话)、mp3播放器、传呼机等)、药物输送装置，这些装置中的每个都可配置成通过有线或无线连接与接收器进行数据通信。另外，数据处理终端105可进一步连接到数据网络(未示出)上，以便存储、检索、更新，和/或分析对应于所检测用户分析物水平的数据。
数据处理终端105可以包括输注装置，如胰岛素输注泵等，其可配置成将胰岛素施用给患者，并可配置成与主接收器单元104通信以便接收尤其是测量的分析物水平。替换地，主接收器单元104可配置成将输注装置集成到其中，以便主接收器单元104配置成给患者施用胰岛素(或其它适当的药物)治疗，例如用于管理和修改基本分布(profile)，以及尤其根据从数据处理单元102接收的所检测分析物水平来确定所施用的适合推注量。输注装置可以是外部装置或内部装置(可完全植入到用户身体内)。
在特定实施例中，可包括胰岛素泵的数据处理终端105可配置成接收来自数据处理单元102的分析物信号，且因此合并了主接收器单元104的功能，包括数据处理以便管理患者的胰岛素治疗和分析物监控。在某些实施例中，如图1所示的通信链路103以及一个或多个其它通信接口可使用一个或更多下列协议：RF通信协议、红外通信协议、蓝牙可通信协议、802.11x无线通信协议，或等效无线通信协议，这将允许几个单元的安全无线通信(例如按照HIPAA要求)，同时避免潜在的数据碰撞和干扰。
如本公开方面描述的，该分析物监测系统可以包括剖面薄的在体贴片装置，其可以佩戴在手臂或身体其它部位上(和佩戴在用户或患者所穿的衣服下)，该在体贴片装置包括分析物传感器、电路和用于操作该传感器以及处理和存储从该传感器接收到的信号以及用于与阅读器装置通信的部件。例如，该在体贴片装置的一方面可以包括电子设备，从而对从与体液流体接触的分析物传感器接收到的电压信号进行采样和将所采集的电压信号加工成相应葡萄糖值和/或存储所采集的电压信号作为原始数据。
在某些实施例中，该在体贴片装置包括从外部装置如本文所述的阅读器装置/接收器单元接收RF电能的天线如回路天线(loop antenna)、将通过天线接收的RF电能转化成供在体贴片装置电路用的DC(直流)电能的电子设备、检测从该阅读器装置接收到的命令的通信模块或电子设备，以及将数据传输给阅读器装置的通信部件、向传感器采样电路(例如，在与分析物传感器信号通信的在体贴片装置模拟前端电路)提供电能的低容量电池、存储包括来自传感器的原始信号或基于该原始传感器信号处理的数据在内的数据的一个或多个非易失性存储装置或存储装置。更具体地，在操作需求模式下，当在阅读器装置的RF电能范围内时，某些实施例中的在体贴片装置配置成传输实时分析物相关数据和/或存储的历史分析物相关数据。因此，当将该阅读器装置移出相对于在体贴片装置的范围时，该在体贴片装置可能不再能够传输分析物相关数据。
在某些实施例中，可以在分析物监测系统中提供数据处理模块/终端，其配置成用作数据记录仪，通过以下步骤与在体贴片装置交流(interact)或通信：例如向在体贴片装置传输分析物水平信息要求，和在数据处理模块的一个或多个记忆部件中对从在体贴片装置获得的响应分析物水平进行分类。进一步地，数据处理模块可以配置成紧凑型在体中继装置，从而将从在体贴片装置接收到的分析物水平信息转运(relay)或重发到阅读器装置/接收器单元或远程终端或二者。一方面中的数据处理模块可以物理地耦接到在体贴片装置上，例如在患者皮肤表面上的单个粘接剂贴片上。或者，可以将该数据处理模块设置成与在体贴片装置靠近但不与其接触。例如，当将该在体贴片装置设置在患者腹部上时，可将该数据处理模块佩戴在患者或用户的带状物上，以便可以将在体贴片装置和数据处理模块之间的期望紧贴距离或预定距离维持为约1～5英尺(或例如，约1～10英尺或更大)。
包括在软件应用程序执行环境下在包括在体贴片装置、阅读器装置、数据处理模块和/或执行上述一个或多个例行程序的远程终端在内的分析物监测系统中运行的过程的上述各种过程，可以具体化为利用面向对象语言形成的计算机编程，该面向对象语言允许带有模块化对象的复杂系统模型化从而创建代表真实世界、物理对象及其相互关系的抽象概念。实施本创造性过程所需的软件可以存储在上面结合附图描述的分析物监测系统各个部件存储单元的记忆或存储装置中，包括在体贴片装置、阅读器装置、数据处理模块、各种描述的通信装置，或远程终端，该软件可由本领域技术人员开发并可以包括一种或多种计算机程序产品。
在一个实施例中，与分析物监测系统双向通信的仪器可以包含一个或多个例行程序存储在其中的存储装置、可操作地耦接到该存储装置上并配置成检索所存储的用于执行的一个或多个例行程序的处理单元、可操作地耦接到该处理单元上并配置成至少部分基于由该处理单元执行的一个或多个例行程序传输数据的数据传输部件，以及可操作地耦接到该处理单元上并配置成从远程位置接收分析物相关数据和将所接收到的分析物相关数据存储在存储装置中用于重传输的数据接收部件，其中该数据传输部件被编程从而向远程位置传输查询(query)，并且进一步地其中在检测到来自数据传输部件的询问后，当远程位置处的一个或多个电子设备从待用状态转换到工作状态时，该数据接收部件从该远程位置接收分析物相关数据，以响应于所传输的查询。
图2示出在本公开一方面中，用于实时葡萄糖测量数据采集和处理的数据监测和管理系统。更具体地，如图2所示，包括耦接到分析物传感器250上的传感器电子设备的在体贴片装置211设置在患者或用户皮肤表面210上。在一方面，可以提供导引器机构，如下面结合图12A～12G进一步详细讨论的，其用于经皮安置分析物传感器250以便当将该在体贴片装置211设置在皮肤表面上时，该传感器250的一部分通过皮肤表面插入并在皮肤层210下与患者或用户的体液流体接触。
该导引器机构可以是完全自动化或部分自动化的，例如，带有触发器机构，或可以是完全手动或部分手动的以便通过用户手动操作经皮设置传感器250。就是说，在一方面，在体贴片装置211可以包括导引器针和/或内腔(lumen)(和/或导管)，其可以在插入过程中引导传感器250通过皮肤层210。在进一步的方面，在体贴片装置211在皮肤层210上的安置包括，初始通过在在体贴片装置211上施加力来刺穿(piece)皮肤层210，同时将在体贴片装置211安置在皮肤层210上，可操作地驱使传感器250(和/或导引器)通过皮肤层210。在本公开范围内，可以在在体贴片装置211中提供机构(如弹簧)，或者替换地，或者在与在体贴片装置211配合的导引器中提供机构(如弹簧)，以便在将传感器250设置成与体液流体接触后抽出导引器针。在某些其它实施例中，可以提供内腔，其中分析物传感器250提供在用于插入的内腔空腔中，并在在体贴片装置211佩戴在皮肤层210上的时间段内与在体贴片装置211维持在适当的位置。
返回参考图2，如图所示，当紧贴并在在体贴片装置211的预定范围内设置或安置阅读器装置/接收器单元220时，阅读器装置/接收器单元220中的RF电能可配置成提供操作在体贴片装置211中的电子设备所需要的电能，并且该在体贴片装置211可配置成在检测到来自阅读器装置/接收器单元220的RF电能后，执行预编程的例行程序，该例行程序包括例如将一种或多种信号240传输给阅读器装置/接收器单元220，指示通过分析物传感器250测量的所采集分析物水平。
在某些实施例中，阅读器装置/接收器单元220可以包括RF电能开关，该RF电能开关是用户可激活的，或在设置到与在体贴片装置211距离的预定距离后被激活从而开启在体贴片装置211中的分析物传感器。就是说，利用该RF信号，可启动或激活耦接到在体贴片装置211中传感器电子设备上的分析物传感器。在另一个实施例中，无源(passive)RFID功能可被提供或编程，以便在接收到“开启”信号后，当得到验证时，该信号将开启激活在体贴片装置211的电子设备电能开关。就是说，无源RFID配置可以包括从由阅读器装置/接收器单元220辐射的RF场提取能量，以便提示(prompt)和/或检测“开启”信号，该信号在得到验证后将激活在体贴片装置211。
在一个实施例中，当如上所讨论的，紧贴在体贴片装置211安置阅读器装置/接收器单元220时，阅读器装置/接收器单元220与在体贴片装置211之间的通信和/或RF电能转移可以自动启动。或者，可以配置阅读器装置/接收器单元220，以便在阅读器装置/接收器单元220与在体贴片装置211之间的通信和/或RF电能转移启动之前要求用户激活，如数据请求启动，并在随后要求用户利用例如阅读器装置/接收器单元220的显示器222和/或输入部件221加以确认。在进一步实施例中，在多种模式之间，阅读器装置/接收器单元220可以是用户可配置的，以便用户可以决定阅读器装置/接收器单元220与在体贴片装置211之间的通信是自动执行还是要求用户激活和/或确认。
如图2进一步示出的，阅读器装置/接收器单元220可以包括显示器222或输出部件从而向用户或患者提供输出指示，该输出指示包括例如相应的葡萄糖水平测量值。阅读器装置/接收器单元220的显示器222可以另外地配置成提供用户界面功能从而向用户呈现其它信息如报警或警报通知。在一方面，阅读器装置/接收器单元220可以包括其它输出部件如扬声器、振动输出部件等，从而除了提供在显示器222上的可视输出指示之外，还向用户提供了可听输出指示和/或振动输出指示。而且，阅读器装置/接收器单元220也可以包括一个或多个输入部件221(如，按钮、开关、电容式滑块(capacitive slider)、转轮(Jog Wheel)等)，通过操作输入部件221可以接收用户或患者输入的命令或信息。在一个实施例中，该显示器222和输入部件221可以集成到单个部件中，例如集成为触摸屏显示器。在此种实施例中，用户可以利用一套预编程的运动命令操纵阅读器装置/接收器单元220，该运动命令包括但不局限于单击或双击显示器、在显示器上拖动手指或仪器、使多个手指朝着彼此移动、使多个手指远离彼此移动等。其它实施例包括“软按钮”的使用，凭借该软按钮输入部件221相当于显示器222上的动态菜单从而控制阅读器装置/接收器单元220的特征和操作。在又一个实施例中，输入部件221可以包括扩音器，并且该阅读器装置/接收器单元220可以包括配置成分析从扩音器接收到的音频输入的软件，以便阅读器装置/接收器单元220的功能和操作可以由用户或患者可听地(audibly)控制。
如所讨论的，一个实施例中在体贴片装置221中的一些或所有电子设备都可以配置成依赖于从阅读器装置/接收器单元220接收到的RF电能从而进行分析物数据处理和/或将经处理的分析物信息传输给阅读器装置/接收器单元220。就是说，在体贴片装置221可以小心地佩戴在用户或患者身体上，在例如衣服下，并且需要时通过将阅读器装置/接收器单元220设置在与在体贴片装置221相距的预定距离内，可以通过阅读器装置/接收器单元220接收实时葡萄糖水平信息。患者期望(或者需要)时可以重复这个例行程序，从而确定在用户或患者佩戴在体贴片装置221的时间段内任何时间点的葡萄糖水平。
仍参考图2，该图也示出了数据处理模块/终端260和远程终端270。在一方面，数据处理模块260可以包括配置成与在体贴片装置221、阅读器装置/接收器单元220和/或远程终端270双向通信的独立装置(standalone device)。更具体地，数据处理模块260可以包括一个或多个微处理器或类似的数据处理部件，它们配置成执行用于通信的一个或多个软件例行程序，以及将数据储存到提供在数据处理模块260外壳中的一个或多个记忆部件中和从其中检索数据。
一个实施例中的数据处理模块260可以配置成以与阅读器装置/接收器单元220类似的方式与在体贴片装置221通信，并可以包括通信部件如尤其是天线、电源和存储器，从而允许向在体贴片装置221提供RF电能或者要求或提示在体贴片装置221发送当前分析物相关数据和任选的其它存储的分析物相关数据。数据处理模块260可以配置成以与阅读器装置/接收器单元220类似的方式与在体贴片装置221交流，使得数据处理模块260可以设置在与在体贴片装置221相距的预定距离内，以便与在体贴片装置221通信。
在一方面，在体贴片装置221和数据处理模块260可以在彼此的预定距离(例如，在近5英尺或更短的距离内)内设置在用户或患者皮肤表面上，以便保持在体贴片装置221和数据处理模块260之间的通信。在进一步方面，数据处理模块260外壳可以配置成与在体贴片装置221外壳耦接或配合，使得该两种装置结合或集成为单个组件并设置在皮肤表面上。
再次参考图2，数据处理模块260可以配置或编程用于以预定时间间隔如每分钟一次，或每五分钟一次，或每30秒一次，或以任何其它合适或期望的可编程时间间隔提示或查验(ping)在体贴片装置211，从而请求来自在体贴片装置211的分析物相关数据，该数据接收并储存在数据处理模块260的一个或多个记忆装置或部件中。在另一个实施例中，数据处理模块260配置成根据患者或用户需要提示或查验在体贴片装置211，而不是基于预定时间间隔提示或查验。在又一个实施例中，数据处理模块260配置成在患者或用户提出请求后仅在经过可编程的时间间隔之后提示或查验在体贴片装置211。例如，在某些实施例中，如果用户没有在编程的时间段例如距离最后一次通信5小时(或距离最后一次通信10小时)内启动通信，则数据处理模块260可通过程序设计自动地查验或提示在体贴片装置211，或者替换地，启动报警功能从而通知用户自从数据处理模块260和在体贴片装置211之间最后一次通信以后延长的时间间隔已过。以这种方式，用户、医疗服务提供者，或患者可以为数据数据处理模块260设定程序或对其进行配置从而提供与分析物监测方案的特定依从性(certain compliance)，以便由用户维持或执行分析物水平的频繁测定。在某些实施例中，类似功能可以提供或编程在接收器单元或阅读器装置中。
如图2进一步示出的，一方面中的数据处理模块260可以配置成，在建立数据处理模块260与阅读器装置/接收器单元220之间的通信时，将从在体贴片装置211接收到的所存储数据传输给阅读器装置/接收器单元220。更具体地，除了RF天线和上述RF通信部件之外，数据处理模块260还可以包括利用一个或多个无线通信协议通信的部件，该无线通信协议为，例如，但不局限于红外(IR)协议、蓝牙协议、Zigbee协议，和802.11无线LAN协议。包括基于蓝牙协议和/或Zigbee协议的那些协议在内的通信协议的另外描述可以在美国专利2006/0193375中找到，该专利通过引用合并在此用于所有目的。数据处理模块260可进一步包括通信端口、驱动程序或连接器，从而建立与阅读器装置/接收器单元220、在体贴片装置211或远程终端270中的一个或多个之间的有线通信，包括例如但不局限于USB连接器和/或USB端口、Ethernet连接器和/或端口、FireWire连接器和/或端口，或RS-232连接器和/或端口。
在一方面，数据处理模块260配置成用作数据记录仪，该数据记录仪配置或编程用于定期地要求或提示在体贴片装置211传输分析物相关信息，和存储所接收到的信息以便以后检索或者随后传输给阅读器装置/接收器单元220或远程终端270或二者以用于进一步处理和分析。进一步地，数据处理模块260中的记忆或存储部件可以大到足够存储或保留在延长时间段，例如与在体贴片装置211中分析物传感器250的使用寿命相一致的时间段内分析物水平信息。以这种方式，上面结合图1和2描述的分析物监测系统可以配置成以CGM(连续葡萄糖监测)模式操作，以便可从在体贴片装置211接收到连续的、时间间隔的所监测分析物水平并将其存储在数据处理模块260中。存储在数据处理模块260中的数据随后提供或传输给阅读器装置/接收器单元220、远程终端270等，以便进一步分析，如识别在监测时间段内血糖水平漂移期间的频率，从而改善或提高治疗相关的决定。利用这种信息，医生、医疗服务提供者或患者可以调整或建议改变饮食、日常习惯与日常行为规律如运动等。
在进一步方面，数据处理模块260的功能可以配置或合并到记忆装置中，如SD卡、microSD卡、紧凑型闪存卡、XD卡、Memory Stick卡、Memory Stick Duo卡，或USB记忆棒/装置，包括驻留在此种装置中在分别连接到在体贴片装置211、远程终端270或阅读器装置/接收器单元220中的一个或多个后执行的软件编程。在进一步方面，包括可执行软件和编程的数据处理模块260的功能可以提供给通信装置，如移动电话，包括例如iPhone、iTouch、Blackberry装置、Palm类装置(如Palm Pre、Treo、Treo Pro、Centro)、个人数字助理(PDA)或任何其它可通信操作系统(如Windows或Android操作系统)类移动电话，如通过下载的通信装置可以执行的可下载的应用程序。为此目的，图2所示远程终端270可以包括个人计算机或服务器终端，该服务器终端配置成在远程终端270和装置之间建立通信时向上述通信装置中的一个或多个提供可执行的应用程序。在又一方面，可执行的可下载应用程序可以作为OTA下载而空中(OTA)提供，使得与远程终端270之间的有线连接没有必要。在这种配置中，可执行应用程序可作为通信装置可利用的下载并依赖于通信装置的配置而被自动下载，安装在装置上供自动使用，或基于通信装置上的用户证实或确认从而执行应用程序的安装。
根据用户对通信装置的设置或配置，下载的应用程序可以利用各个通信装置的用户界面(屏幕、键盘等)进行编程或定制，从而确立所期望的设置或为所期望的设置进行编程，如高血糖报警、低血糖报警、传感器更换报警、传感器校准报警，或用户可能期望的任何其它报警或警报状况。而且，通信装置上的编程通知设置可以利用各个通信装置的输出部件输出，如扬声器、振动输出部件或可视输出/显示。作为进一步实例，可以提供这样的通信装置，其具有与在体贴片装置211通信以便确立数据采集频率或周期的编程和应用程序软件。以这种方式，该通信装置配置成方便地以预定时间周期，例如，但不局限于每分钟一次、每5分钟一次，或每10或15分钟一次，从在体贴片装置211接收分析物水平信息，并存储所接收到的信息，以及提供所监测或所接收到的分析物水平信息的实时显示和其它相关输出显示，如分析物水平趋势指示(例如，基于所接收到的分析物水平信息)、基于该分析物趋势的未来分析物水平预测，以及对用户或患者的任何其它期望或适当的指示或通知。
信息如趋势信息，例如可以在阅读器装置/接收器单元220、数据处理模块260、远程终端270，或带有输出功能的任何其它连接装置中的一个或多个上输出。趋势和其它信息可以在装置的显示单元，例如阅读器装置/接收器单元220的显示器220上输出。趋势信息可以显示为例如图表(如线图)从而指示用户或患者由分析物监测系统测量和预测的当前、历史和预测的未来分析物水平。趋势信息也可以显示为趋势箭头，指示该分析物水平是否增加或降低以及分析物水平增加或降低是否增速或减速。用户或患者可以利用这种信息确定确保分析物水平仍然在可接受和/或临床安全范围内的任何必须的纠正措施。也可以将其它目视指示器，包括颜色、闪烁、褪色等，以及音频指示器，包括音频输出和/或振动音高、音量或音调变化，或者其它触觉指示器合并到趋势数据显示器中，作为通知用户或患者所监测分析物的当前水平和/或方向和/或水平变化率得工具。
另外，当与数据处理模块260的功能集成在一起时，上述通信装置可编程用于以任选的CGM模式操作，从而从在体贴片装置211中接收时间间隔的所监测分析物水平信息。
返回参考图2中的远程终端270，在一方面，当远程终端270与阅读器装置/接收器单元220和/或数据处理模块260之间建立通信时，远程终端270可以向阅读器装置/接收器单元220、在体贴片装置211或数据处理模块260提供尤其是软件更新如软件补丁、固件更新或驱动程序升级。在又一方面，在体贴片装置211的软件升级、编程变化或修改可以从远程终端270通过阅读器装置/接收器单元220或数据处理模块260接收，并在此后通过阅读器装置/接收器单元220或数据处理模块260提供给在体贴片装置211。
图3是接收器/监测器单元的框图，如根据某些实施例的图1所示的接收器/监测器单元。主接收器单元104(图1)包括下面中的一个或多个：血糖测试条接口301、RF接收器302、用户输入端303、温度检测器部分304，和时钟305，它们中的每个都可操作地连接到处理和存储部分307上。主接收器单元104还包括可操作地耦接到电源转换和监测部分308上的电源306。进一步地，电源转换和监测部分308还耦接到接收器处理和存储部分307上。而且，还示出了接收器串行通信部分309和输出/显示端310，它们分别可操作地耦接到处理和存储部分307上。该接收器可以包括用户输入端和/或接口部件或者可以不包括用户输入端和/或接口部件。
在某些实施例中，测试条接口301包括葡萄糖水平测试部分从而接受血液(或其它体液样本)葡萄糖测试或接收与其相关的信息。例如，该接口可以包括测试条端口从而容纳葡萄糖测试条。该装置可以确定测试条的葡萄糖水平，并可选地在主接收器单元104的输出/显示端310上显示(或以其它方式提醒)葡萄糖水平。可以使用任何适合的测试条，例如，为了获得准确的葡萄糖信息，仅需要将很少量(例如，1微升或更少，例如，约0.5微升或更少，例如，0.1微升或更少)的样品施加到测试条上的测试条，例如来自Abbott Diabetes Care Inc.的FreeStyle或Precision血糖测试条和系统。可以将通过体外葡萄糖测试装置获得的葡萄糖信息用于多种目的、计算等。例如，该信息可以用于校准传感器101，确认传感器101的结果从而提高其可信度(例如，在与治疗相关的决定中采用通过传感器101获得的信息的情况下)等。
在一方面，RF接收器302配置成通过通信链路103(图1)与数据处理单元(传感器电子设备)102通信，从而从数据处理单元102中接收编码数据用于，尤其是，信号混合、解调以及其它数据处理。主接收器单元104的用户输入端303配置成允许用户根据需要将信息输入到主接收器单元104中。在一方面，用户输入端303可以包括小键盘的按键、触敏屏和/或语音激活的输入命令单元等。温度监测部分304可以配置成向处理和存储部分307提供主接收器单元104的温度信息，而时钟305尤其是向处理和存储部分307提供实时或时钟信息。
图3中所示的主接收器单元104的各种部件中的每个均由电源306(或其它电源)提供电能，在某些实施例中，电源306包括电池。此外，电源转换和监测部分308配置成监测主接收器单元104中各种部件的电能使用情况以便有效管理电源，并且它可以在例如，电能使用使主接收器单元104处于欠佳运行状况的情况下提醒用户。主接收器单元104中的串行通信部分309配置成提供从测试和/或制造装置开始的双向通信通路以便进行尤其是主接收器单元104的初始化、测试和配置。
串行通信部分309还可以用于将数据上传到计算机，如标记了时间的血糖数据。可以通过电缆(如USB或串行电缆)、红外(IR)或RF链路制成与外部装置(未示出)之间的通信链路。主接收器单元104的输出/显示端310配置成提供尤其是图形用户界面(GUI)，并且可以包括显示信息的液晶显示器(LCD)。另外，输出/显示端310还可以包括集成化扬声器以输出可听信号，并且提供了在如移动电话、寻呼机等手持电子设备中常见的振动输出。在某些实施例中，主接收器单元104还包括电致发光灯，其配置成向黑暗环境中的输出/显示端310提供输出可见显示的背光。
再参考图3，主接收器单元104还可以包含作为处理和存储部分307的一部分的存储部分，如可编程的非易失性存储装置，或者在主接收器单元104中单独提供并可操作地耦接到处理和存储部分307上的存储部分。处理和存储部分307可以配置成在通过通信链路103接收到来自数据处理单元102的编码数据后进行曼彻斯特解码(或其它协议(或多种其它协议))以及误差检测和修正。
在进一步实施例中，数据处理单元102和/或主接收器单元104和/或次接收器单元106，和/或数据处理终端/输注部分105可以配置成通过通信链路从例如血糖计无线地接收血糖值。在进一步实施例中，用户操作或使用的分析物监测系统100(图1)可以利用，例如，合并到数据处理单元102、主接收器单元104、次接收器单元106、或数据处理终端/输注部分105中的一个或多个的用户界面(例如，键盘、小键盘、语音命令等)手动地输入血糖值。
美国专利5262035、5264104、5262305、5320715、5593852、6175752、6650471、6746582和在2003年12月26日提交的标题为“ContinuousGlucose Monitoring System and Methods of Use”的第10/745878号专利申请，现美国专利号7,811,231，以及在2005年2月16日提交的标题为“Method and System for Providing Data Communication in ContinuousGlucose Monitoring And Management System”的第11/060,365号专利申请中提供了其它详细说明，以上每篇专利通过引用合并在此。
图4是阅读器装置/接收器单元的框图，如本公开一方面中的图2所示的阅读器装置/接收器单元。参考图4，在一方面，该阅读器装置/接收器单元包括控制单元410，如可操作地耦接到显示器430和用户界面420上的一个或多个微处理器。该阅读器装置/接收器单元也可以包括与其它装置数据通信的一个或多个数据通信接口如USB端口(或连接器)470或RS-232端口450(或任何其它的有线通信接口)，该其它装置为，例如个人计算机、服务器、移动计算装置、移动电话、寻呼机或其它手持式数据处理装置，包括智能手机如Blackberry、iPhone和Palm类移动装置，其具有数据通信和处理功能，包括数据存储和输出。
参考图4，也提供了电源440如一个或多个电池，电源440可操作地耦接到控制单元410上并配置成提供该阅读器装置/接收器单元运行所必需的电能。另外，仍然再次参考图4，该阅读器装置/接收器单元可以包括回路天线481如433MHz(或其它等效的)回路天线，该回路天线耦接到接收器处理器480(其可以包括例如433MHz接收器芯片)上，以便与在体贴片装置/传感器数据处理单元中的传感器电子设备无线通信。另外，提供了主感应式(inductive)回路天线491，该回路天线耦接到方波驱动器490上，该方波驱动器可操作地耦接到控制单元410上。
还参考图4，该分析物监测系统的阅读器装置/接收器单元可以包括条端口460，条端口460配置成容纳体外测试条，并耦接到控制单元410，进一步地，其中该控制单元410包括对条端口460中接收到的体外测试条上的样品进行处理的编程。此外，在本公开范围内，图4所示阅读器装置/接收器单元的一些部件可以集成为单个部件，如用户界面420，并且显示器430可以配置为单个触敏显示器，该单个触敏显示器可以配置成包括显示自身的软按钮，该软按钮是用户或患者可操作的，用于向阅读器装置提供输入命令或信息。
在一方面，本文所述分析物监测系统的阅读器装置/接收器单元可以配置成包括类似于USB记忆装置的紧凑性状因素(compact form factor)，其中USB端口470可以配置为用于插入或连接到另一个装置如个人计算装置等上USB端口的USB连接器。此种紧凑形状因素可以包括上述阅读器装置/接收器单元中的一些或所有部件。
图5是在体贴片装置的示例示意图，该在体贴片装置包括在本公开一方面的图1和图2中的分析物监测系统中使用的集成传感器和传感器电子组件。如图5所示，在一方面，分析物监测系统的集成传感器和传感器电子组件/在体贴片装置可以包括将分析物相关数据传输给阅读器装置/接收器单元的回路天线520，进一步地，感应式回路天线530，该感应式回路天线用于处理来自阅读器装置/接收器单元的RF电能，并包括将该RF电能转换为相应的用于操作在体贴片装置电子设备的DC电能。以这种方式，在本公开的一方面，该在体贴片装置可以经配置用作采用耦合电能(coupling power)，而不需单独电源或电池来进行数据传输的无源数据传输器(passive data transmitter)。此外，在一方面，该在体贴片装置不需要开启装置为运作模式的机构，也不需要停用或关掉该在体贴片装置的机构。就是说，当该在体贴片装置检测到来自阅读器装置的RF电能时，它可以配置成进入工作或运行模式。图5进一步示出了多个超级电容器C1、C2，其耦接到感应式电能回路天线530和控制器510上。还参考图5，控制器510可以提供在印刷电路板组件上，该印刷电路板组件包括回路天线520、热敏电阻器(未示出)、用于耦接到传感器540的电极上的分析物传感器触摸板、一个或多个存储装置如永久性存储器(未示出)，以及其它分立部件。在某些方面，该印刷电路板组件可以部分地或全部地与例如灌封材料一起封装。
图6是图1和图2以及本公开另一方面中的分析物监测系统中使用的集成传感器和传感器电子组件。参考图6，在本公开的某些方面，该在体贴片装置包括控制单元610(如，例如，但不局限于一个或多个微处理器，和/或特定用途集成电路(ASIC))，该控制单元可操作地耦接到模拟前端电路670上从而处理信号，如从传感器680接收到的原始电压或电流信号。图6中还示出了存储器620，其可操作地耦接到控制单元610上用于存储由控制单元610执行的数据和/或软件例行程序。就是说，除了检索用于执行的一个或多个所存储例行程序外，控制单元610还可以配置成访问存储在存储器620中的数据或例行程序从而更新、存储或替换存储器620中的信息。图6还示出了电源660，其在某些实施例中向该在体贴片装置电子设备提供电能以便使其在控制单元610的控制下运行，从而处理来自传感器680的信号和存储经处理的传感器数据，以便随后在阅读器装置/接收器单元提示或查验除了实时分析物水平数据之外还需要传输所存储数据时传输给阅读器装置/接收器单元。如上所讨论的，在某些实施例中，该在体贴片装置不包括电源660，并配置成依赖来自该阅读器装置的RF电能。
另外，如图6所示，给该在体贴片装置提供了可选的输出单元650。在某些实施例中，输出单元650可以包括LED指示器，例如从而向用户或患者报警提醒与该在体贴片装置运行关联的一个或多个预定状况和/或预定分析物水平。例如，在一方面，该在体贴片装置可以编程或配置成提供可视指示，从而通知用户该在体贴片装置的一个或多个运行状况。用户或患者或医疗服务提供者可以对该一个或多个预定运行状况进行配置，以便某些状况与该在体贴片上的输出指示关联。作为非限制性实例，该在体贴片装置可被编程用于在来自传感器680的信号被指示超出编程的可接受范围(基于一个所采集的传感器数据点，或多个传感器数据点)，潜在地指示健康风险状况如高血糖或低血糖或者此种状况的发病时，利用该在体贴片装置上的LED指示器发出通知。利用此种提示或指示，用户或患者可被及时告知此种潜在的状况，并且利用该阅读器装置从该在体贴片装置获得葡萄糖水平信息从而确认此种状况是否存在，以便及时采取纠正措施。
在某些实施例中，该在体贴片装置可以包括扬声器或可听输出部件以代替LED指示器，或与LED指示器一起提供一种或多种上述此种状况的可听指示。可听输出类型可以，例如经由阅读器装置编程或可编程在在体贴片装置中，并可以包括标准的可听音调(单音调或多音调)，或包括提供给在体贴片装置的一种或多种铃声。在某些实施例中，不同状况可以与不同类型的可听输出/警报关联，以便患者可以容易地基于可听通知类型辨认潜在的检测状况。例如，不同类型的可听音调可以与不同状况关联(由用户或患者编程或预编程在在体贴片装置中)，以便当显示时，用户或患者可以容易地辨认每种输出音调所指示的特定相关病况。就是说，基于来自分析物传感器的信号检测到的高血糖病况发病可能与第一预定的响度和/或音调关联，而基于来自分析物传感器的信号检测到的低血糖病况发病可能与第二预定的响度和/或音调关联。或者，该编程或可编程的可听报警可以包括基于时间间隔序列或指示响度水平增大/减小的序列(利用相同的音调，或逐渐增大或减小的音调)输出的一种或多种可听输出序列。
此外，在本公开的方面中，该可听输出指示可以与可视输出指示器同时或交替地显示，如可以被定制或可编程在在体贴片装置中或可预编程。
再次参考图6，当在提供RF电能的阅读器装置/接收器单元的预定接近范围内时，可操作地耦接到控制单元610上的天线630和通信模块640可以配置成检测和处理RF电能，以及进一步地，作为回应而将分析物水平信息和可选的基于所存储分析物水平数据的分析物趋势信息传输给阅读器装置。在某些方面，该趋势信息可以包括在预定时间段内存储在在体贴片装置存储器620中并提供给包含实时分析物水平信息的阅读器装置/接收器单元的多种分析物水平信息。例如，该趋势信息可以包括自从最后一次给阅读器装置传输分析物水平信息以后的时间段内的一系列时间间隔分析物水平数据。或者，该趋势信息可以包括存储在存储器620中并在控制单元610的控制下被检索用于传输给阅读器装置的前30分钟或1小时的分析物数据。
返回参考该图，在一方面，该在体贴片装置和阅读器装置/接收器单元可以配置成利用RFID(无线电波频率辨识)技术通信，其中该阅读器装置/接收器单元配置成通过RF通信链路询问在体贴片装置(与RFID标签关联)，以便该在体贴片装置响应于来自阅读器装置的RF询问信号而传输RF响应信号，该RF响应信号包括，例如，与来自传感器的所采集分析物水平关联的数据。关于RFID通信操作的其它信息可以在美国专利公开2009/0108992和美国专利7,545,272中找到，它们的公开内容通过引用合并在此。
例如，在一个实施例中，阅读器装置/接收器单元可以包括后向散射RFID阅读器，其配置成传输RF场，以便当在体贴片装置在所传输RF场范围内时，它的天线被调谐并反过来向该阅读器装置提供反射或响应信号(例如，后向散射信号)。该反射或响应信号可以包括来自分析物传感器的所采集分析物水平数据。
在一方面，可以对阅读器装置/接收器单元进行配置，以便当该阅读器装置/接收器单元紧贴在体贴片装置设置并接收来自在体贴片装置的响应信号时，该阅读器装置/接收器单元配置成输出确认分析物水平测量值采集情况的指示(可听指示、可见指示或其它方式的指示)。就是说，在身体上佩戴在体贴片装置的5～10天的过程中，用户或患者可在任何时间将阅读器装置/接收器单元设置在与在体贴片装置相距预定距离(例如，约1～5英尺)的位置处，并在等待几秒之后输出可听指示，以确认实时分析物水平收到情况。所接收到的分析物信息可以输出给阅读器装置/接收器单元的显示器430(图4)以便呈现在用户或患者面前。
如上所示，在体贴片装置配置成在预定时间段内佩戴在用户或患者身体上。因此，下述某些实施例包括在体贴片装置的配置从而提供紧凑型配置，该紧凑型配置被配置成在预定佩戴时间段内一直舒服地粘附在皮肤表面上而不与皮肤表面分开。例如，在一方面，该在体贴片装置可以包括单集成化外壳或单体组件，其包括分析物传感器、电子设备和粘接剂通路(adhesive path)。此种配置提供了需要患者或用户操纵的几个部分，提高了易用性，并且进一步地，利用包覆成型(overmolded)组件，该配置可以配置成在佩戴过程中提供期望的水密封性，阻止湿气或其它污染物进入在体贴片装置外壳。此种单体配置可以另外地提供易制造性，其中需要组装的部件较少。
在进一步方面，该在体贴片装置可以包括两部分组件，该两部分组件包括配合(mated)或耦接(可分开地或固定地)到一次性(disposable)部件上的可再用电子部件，该一次性部件包括分析物传感器、电子部件的基座(base)或支架(mount)，以及粘接剂贴片。
图7是在根据本公开一方面的图1和2中的分析物监测系统中使用的阅读器装置/接收器单元的示意图。参考该图，根据本公开一方面的阅读器装置/接收器单元220(图2)或手持式控制器包括表面声波(SAW)谐振器701，该表面声波(SAW)谐振器可以包括与振荡器(OSC)702一起运行产生RF信号的谐振器。振荡器702是有源RF晶体管部件，并且与SAW谐振器一起配置成发送控制命令(查验信号)、传输RF电能从而从在体贴片单元接收后向散射信号，和向混频器703产生本地振荡信号，如下面进一步详细描述的。
更具体地，在本公开的一方面中，在操作中，所示的传输数据(TX数据)是从阅读器装置/接收器单元(参见例如图4)的控制单元410接收到的控制信号和从功率放大器(PA)706接收到的控制信号，是待传输到在体贴片装置的RF控制命令。一个实施例中的SAW谐振器701配置成提供控制命令的载波信号(查验信号)。来自一个实施例中控制单元410的控制信号包括待传输到在体贴片装置从而查验它是否使响应信号返回到阅读器装置的数据包。
在一个实施例中，在发送控制信号之前，在TX启动信号线(enableline)(如图7所示)处接收到来自控制单元410的接通信号(turn on signal)，并将其提供给振荡器702。在将来自控制控制单元410的控制信号提供给振荡器702和SAW谐振器701之后，维持用于承载控制信号的载波信号。一个实施例中，可以利用相同载波信号从在体贴片装置接收响应数据包。当利用回路天线并通过载波信号将RF控制信号提供给在体贴片装置时，同时提供了RF电能(辐射能量)，其中RF电能由振荡器702与SAW谐振器701一起产生。在某些方面，因为维持了传输/接收时间段内阅读器装置/接收器单元与在体贴片装置之间的载波信号，所以在RF控制信号的查验(或控制信号)请求传输期间以及在当从在体贴片装置接收到后向散射响应的时间段内提供RF电能。在某些方面，阅读器装置/接收器单元回路天线708利用相同的载波信号将RF电能和RF控制信号传输给在体贴片装置。
返回参考图7，进一步示出了LC功率分配器704，其在本公开一方面中配置成将功率以两路分配到缓冲器705和功率扩大器(PA)706。缓冲器705在一个实施例中配置成放大(boost)从LC功率分配器704接收到的RF信号。功率扩大器706的输出是提供给第二LC功率分配器707的控制命令，该第二LC功率分配器707可分配天线信号(将来自回路天线的天线信号分成传输信号(控制信号)和接收信号(来自在体贴片装置的后散射信号)。就是说，在一个实施例中，该第二LC功率分配器707可以配置成利用一个回路天线708管理输出/接收信号。再次参考图7，提供在回路天线708和第二LC功率分配器707之间的Balun(平衡-不平衡变压器)709在一个实施例中用于使来自回路天线708的平衡信号和来自功率放大器707的不平衡信号相匹配(因为大多数电路部件相对于地面终端是不平衡的)。平衡-不平衡变压器709在一个实施例中包括电力变压器，其可以利用操作用的电磁耦合将对于地面平衡(差分)的电信号转化成不平衡(单端)信号，反之亦然。
还参考图7，回路天线708传输RF控制信号(查验信号)，并且作为回应而从在体贴片装置接收后向散射信号。在一方面，回路天线所接收到的后向散射响应信号经过平衡-不平衡变压器709，并传到功率分配器707到达SAW滤波器711。SAW滤波器711在一方面包括带通滤波器，该带通滤波器配置成除去例如所接收到的后向散射信号中的噪音或干扰组分。SAW滤波器711的输出经过ASK接收器720。在一方面，ASK接收器720包括低噪音放大器(LNA)721，该低噪音放大器(LNA)721的输出发送到混频器703，该混频器将从LNA721输出的低噪音放大信号与来自缓冲器705的RF载波信号混合。
混频器703的输出信息传到滤出该信号中的DC组分和低频组分的高通滤波器(HPF)712，然后HPF712的输出信息发送到配置成放大所接收到信号的中频放大器(IF放大器)713。来自IF放大器713的放大输出信号提供给ASK接收器720的低通滤波器(LPF)722，并且来自LPF722的输出低通滤波后的信号提供给ASK接收器720的另一个中频放大器723，其配置成放大从LPF722输出的低通滤波后的信号。如图7所示，ASK接收器720的IF放大器723提供在LPF722和ASK调制器724之间。
再参考图7，来自ASK接收器720的IF放大器723的增益控制器信号(gain controller signal)控制接收滤波后的后向散射信号的低噪音放大器(LNA)721。在一个实施例中，该增益控制器信号在LNA721的高增益状态和低增益状态之间切换。例如，如果IF放大器723具有高增益，则通往LNA721的增益控制器信号使LNA721切换为低增益操作，反之亦然。如上所讨论的，ASK接收器720的IF放大器723的输出提供给ASK接收器720的ASK调解器724，该调解器配置成从IF放大器723中调解输出信号(恢复数据)。
就是说，如图7所示，通往ASK接收器720的RX启动信号线配置成在TX启动信号线之后接通，其中来自控制单元410(图4)的接通信号接收在阅读器装置/接收器单元中，以便利用来自控制单元410的接收使能信号，ASK接收器720的数据输出线(即，ASK调解器724的输出信息)提供与基于来自葡萄糖传感器的原始电流信号监测的葡萄糖水平关联的数据或信号。
返回参考该图并如上所述，在一方面，该在体贴片装置可以包括给电子部件以及传感器提供电能的电源，或者，该在体贴片装置可能不包括单独的专用电源，而是包括自供电的传感器，如美国专利申请12/393,921中进一步详细描述的，该专利申请提交于2009年2月27日，其通过引用合并在此用于所有目的。在某些方面，对于包括电源的在体贴片装置的配置，该在体贴片装置可以配置成倾听来自阅读器装置的RF控制命令(查验信号)。更具体地，可以在在体贴片装置中提供开关键控制式(On/Off Key)(OOK)检测器，其通过该电池开启和供电从而倾听来自阅读器装置的RF控制命令或查验信号。OOK检测器的另外详细信息提供在美国专利公开2008/0278333中，该美国专利公开的内容通过引用合并在此用于所有目的。在某些方面，当检测到RF控制命令时，在体贴片装置确定需要什么响应包，并产生该响应包以便传输回到阅读器装置。在这个实施例中，该传感器始终处于开启状态并配置成连续地接收来自在体贴片装置电源或电池的电能。然而，从传感器采集的电流信号将无法传输到阅读器装置/接收器单元，直至该在体贴片装置接收到RF电能(来自阅读器装置/接收器单元)从而使数据能被传输到阅读器装置。在一个实施例中，该电池可以是可充电电池，当在体贴片装置接收到RF电能(来自阅读器装置/接收器单元)时可配置该充电电池使其充电。
在某些实施例中，在体贴片装置不包括RF通信芯片，也不包括允许无线传输独立于基于从阅读器装置/接收器单元接收到的RF电能供电和给阅读器装置传输后向散射响应的任何其它专用通信芯片。
再次参考图7，在本公开的进一步实施例中，可向阅读器装置/接收器单元220(图2)提供RF传输器芯片或ASK传输器从而代替图7所示的SAW谐振器701、振荡器702、混频器703、LC功率分配器704、缓冲器705、功率放大器706、高通滤波器(HPF)712，和IF放大器713。更具体地，在这个阅读器装置实施例中，该RF传输器芯片可以耦接到晶体上，该晶体提供用于产生RF载波信号的基准频率参考(frequency referencebase)从而从在体贴片装置接收后向散射，而且将控制命令(查验信号)发送到在体贴片装置。
在上面讨论的实施例中，在本公开的方面中，除了与图7所示SAW滤波器711和ASK接收器720类似的SAW滤波器和ASK接收器之外，该RF传输器芯片或单元还可以耦接到与图7所示LC功率分配器707、平衡-不平衡变压器709和回路天线708类似的LC功率分配器、平衡-不平衡变压器和回路电线。然而，与图7所示配置相比之下，在供替换实施例中，另一个晶体可以耦接到ASK接收器上从而提供基准频率参考，以便从在体贴片装置接收后向散射信号。
图8A和8B分别示出在体贴片装置天线和电子电路部署的顶视图和侧视图，该在体贴片装置包括在本公开一方面的图1和2中的分析物监测系统中使用的传感器和传感器电子组件。参考图8A和8B，在一个实施例中，在体贴片装置的天线和电路部署包括提供在衬底802上的导电层801，如PCB铜线(copper trace)，并进一步包括安置在衬底上并电连接到回路配置中导电层801上的多个感应器803a～803e。在一方面，该感应器803a～803e在该回路配置周围等距离地间隔开。在进一步方面，该感应器803a～803e在该回路配置中彼此间距可能不是等距离的。图8A和8B还示出与导电层801电通信的数据处理器或控制器804，该导电层801除了处理来自阅读器装置/接收器单元的控制命令以及产生和/或传输后向散射响应数据包到阅读器装置之外，还用于处理来自传感器(未示出)的信号并与触感器结合。
因此，在本公开的方面，在超高频(UHF)频段下为无源葡萄糖传感器和低功率葡萄糖阅读器装置/接收器单元提供了回路天线配置，其提供了按需葡萄糖数据采集系统，该系统包括阅读器装置/接收器单元，其配置成产生强大的近电磁场(strong near electromagnetic field)从而给该无源葡萄糖传感器提供电能，并进一步提供微弱的远电磁场以便在远距离，如距离包括传感器在内的在体贴片装置大约3米的距离产生的电磁场强度符合监管的辐射水平。
在某些实施例中，该在体贴片装置天线可以印成印刷电路板的内部导电层，其被顶层和底层上的接地层所围绕。就是说，在一方面，该顶层和底层导电层可以被设置在其间的电介质层和回路天线导电层分开。进一步地，在体贴片装置的天线可以印在与多个感应器芯片串联的印刷电路顶部导电层上，该感应器芯片为，例如，但不局限于五个感应器元件。
图9示出在体贴片装置的示例电路原理图，该在体贴片装置包括根据本公开方面的传感器和传感器电子组件。参考该图，在一个实施例中，提供了传感器触头(sensor contacts)910，从而确立与传感器各个电极的接触，包括工作电极、参考电极和反电极。也示出了可操作地耦接到控制单元950上的RF传输天线920。在某些实施例中，控制单元950可以作为特定用途集成电路(ASIC)而实现，或包括微处理器或二者结合。图9也示出了下面进一步详细描述的激活开关930，该开关沿着电源940的电通路，用于开启或接通在体贴片装置的传感器电子设备。
还参考图9，也示出模拟前端电路/部件970，其耦接到传感器触头910上，用于处理由分析物传感器产生并在传感器触头910处检测到的原始电流信号。示出另外的无源存储电容器960，其耦接到电源如电池上。另外，提供如图9所示的晶体振荡器980、990，其中在某些实施例中，晶体振荡器980配置成为ASIC950中的状态机提供时钟信号，而晶体振荡器990可以配置成为ASIC950内的RF通信部件提供频率参考。
图10A是在体贴片装置的部件的透视图，该在体贴片装置包括根据本公开一方面的传感器和传感器电子组件。参考图10A，示出一个实施例中的图1中的集成传感器和传感器电子组件/在体贴片装置110。可以看出，一个实施例中的外壳1010基本上是这样定形的，以便使其高度剖面减到最小(例如，减到小于或等于约10mm，例如，约4mm或更小)。例如，如该图所示，该集成组件的外壳可以为圆顶状，或者以其它方式逐渐变细的性状。高度尺寸至多可以为约4mm，并可以逐渐变细(渐渐地或逐步地)到高度小于约4mm，例如，3mm或更小，例如2mm或更小，例如1mm或更小。
返回参考图10A，在一个实施例中，分析物传感器1020与传感器电子设备1030一起组装(例如，提供给用户)并提供在外壳1010中。此外，粘接剂(单面或双面)层1040(图10C)可以提供在外壳1010的下表面上从而使外壳1010在传感器部署期间和之后安全地设置在皮肤表面上。如下面进一步详细讨论的，该集成传感器和传感器电子组件/在体贴片装置110可以设置(例如，在制造期间提供给用户)在插入装置外壳中，避免了在插入传感器和开启传感器电子设备之前用户排列、设置或以其它方式连接或耦接该传感器和传感器电子设备与插入装置的必要。因此，可以避免下列问题：误用的可能、传感器相对于插入装置导引器未对准，或用户使用集成组件存在的错误和困难。
图10B是在体贴片装置的部件的另一个透视图，该在体贴片装置包括根据本公开一方面的传感器和传感器电子组件。如该图所示，在一个实施例中，使集成组件的每个部件分离从而示出每个部件的相对位置。如下面进一步详细讨论的，在一个实施例中可以看出，传感器1020包括弯曲配置，借此可以使该传感器机体的至少一部分保持在与皮肤表面基本在一个平面的方向上。在一方面，这种配置使得包括传感器1020的外壳1010剖面尺寸小，以便当将外壳1010设置在用户皮肤表面上时，可以使其突起部减到最小。因此，传感器1020可以是弯曲的，或可以是可弯曲的，弯曲范围可以为约1度到约90度或更大。
图10C是根据本公开一方面的组装的在体贴片装置的另一个透视图，该贴片装置包括传感器和传感器电子组件。如图10C所示，在设置该集成传感器和传感器电子组件之后，粘接剂层1040配置成将集成组件110基本上固定地保留在皮肤表面上，以便将佩戴该装置期间传感器1020的移动减到最小。在一方面，粘接剂层1040配置成在预定穿戴时间段内在集成组件110和皮肤表面之间提供相当大的水密封性，使得集成组件110与皮肤表面分开的可能性减到最小。
图11A～11C示出在体贴片装置中传感器电子组件的电路部署，该在体贴片装置包括根据本公开实施例的传感器和传感器电子组件。参考图11A～11C，集成组件的传感器电子设备实施例包括为减小而优化，并因而使使用和穿戴舒适性最大化的尺寸。例如，图11A～11C所示传感器电子设备实施例可以包括约25mm或更小的直径(例如，典型的二十五美分硬币(quarter coin)大小)，例如，20mm或更小，或15mm或更小的直径。如图所示，例如，提供了包括特定用途集成电路(ASIC)的控制单元1110，其与基本上设置在例如柔性电路板外围的多个RF通信传输电容器1130电接触。根据电路板尺寸和/或RF传输要求，可提供不同电容量的RF传输电容器1130。例如，图11A示出600μF的RF传输电容器1130，而图11B和11C分别示出具有约610μF和240μF的RF传输电容器1130。
返回参考该图，也示出电池1120，其配置成提供操作该传感器电子设备所需的电能，并可以包括可在使用一次之后任意处理的一次性使用的，但足以提供在期望时间段(例如，5天或7天或更长)内操作该集成传感器和传感器电子组件110(图1)所需电能的硬币型电池。另外，图11A～11C进一步示出了RF天线1140，在一个实施例中其基本上围绕柔性电路板的一部分的圆周设置。
因此，在本公开的方面，通过将该各种部件以与图11A～11C所示的方式设置，可优化该传感器电子设备的电路部署从而使该电路板表面积最小化(因而使该集成组件总尺寸最小化)。
图12A～12B示出用于设置在体贴片装置的插入装置在部署前和插入后的配置，该在体贴片装置包括根据本公开实施例的传感器和传感器电子组件。参考图12A，一个实施例中的插入装置1200包括配置成使该插入装置开口端闭合或密封的外壳或机体1210和盖子1220。如图所示，该插入装置1200配置成在基本垂直于皮肤表面的方向上插入传感器和设置传感器电子组件。
参考图12B，当在箭头1240所示的方向上对外壳1210顶端施加力，例如手动施力，并将该外壳的开口端放在皮肤表面1230上时，提供在外壳(未示出)内的集成传感器和传感器电子组件经配置而与皮肤表面1230接触。此外，如上所述讨论的施加力也可以配置成使导引器(未示出)在与箭头1240所示方向相同的方向上移动到外壳内从而透入皮肤表面1230中并设置传感器以使其与用户分析物流体接触。
下面结合图12C～12G进一步详细示出和描述了与传感器插入和传感器电子组件设置用的插入装置关联的机构，该图示出用于部署在体贴片装置的插入装置在运行时的横断面透视图，该在体贴片装置包括根据本公开实施例的传感器和传感器电子组件。
如这些图所示，响应于施加在插入装置外壳1210上的力，导引器1260在基本垂直于皮肤表面1230的方向上被驱动，并且导引器1260、传感器1280和传感器电子组件1270在相同方向上移动。当传感器电子组件1270的底表面与皮肤表面1230接触时，该底表面通过例如粘接剂层1290(图12G)与皮肤表面1230保持在粘接关系中。而且，该图也示出偏置弹簧1250，其在一个实施例中配置成使导引器针从插入位置回缩到内缩位置(retracted position)，这是与箭头1240(图12B)所示方向相反的方向。
返回参考该图，可以看出，该导引器针1260在传感器插入之后基本上完全保留在插入装置外壳1210中，此后当该将该插入装置1200从皮肤表面1230中移出时，该传感器电子组件1270保留在皮肤表面1230上，同时传感器1280保持在与皮肤层1230下的用户分析物流体接触的位置处。
在激活集成传感器和传感器电子组件用于使用之前，制造后该组件可能有一段时间处于睡眠或空闲模式。利用集成在该组件中的电源如电池，出于包括成本优化和延长贮存寿命的原因，本公开实施例包括仅通过将该传感器和电子单元设置在如上所述皮肤表面上而被激活的系统，即，除了对外壳1210施加力外，用户无需另外采取另外的措施。因此，插入传感器可以使电子单元激活。在某些实施例中，包括激活开关配置，其配置成例如通过该插入装置激活而被触发，从而开启集成传感器和传感器电子组件，使其进入工作模式。
例如，图13A～13B示出在体贴片装置的电源开关机构实施例，该电源开关机构包括导电插头，该在体贴片装置包括根据本公开实施例的传感器和传感器电子组件。如图所示，传感器电子组件电路板1310可以具有使传感器电子组件的电源(例如电池)和其它电路之间的电路断开的物理缺口(physical gap)1350。
在一个实施例中，当将预定力施加在如上所讨论的插入装置上时，提供在传感器电子设备外壳内的导电部分1320可以在箭头1330所示方向上移动，以便通过例如使导电部分1320与电路板的导电部分1360物理接触而在电路板上的物理缺口1350中建立电控制。以这种方式，在一个实施例中，完成来自传感器电子设备电路板上的电源和其余电路的电通路，从而给该传感器电子设备提供电能。
通过另一个实例，参考图13B，该电路板的导电部分1360本身就提供在该板上，并且当将例如导电插头1340推进空腔1350时，其建立了该电路板的导电部分1360之间的电接触。
在如上所讨论的一个实施例中，用于设置传感器和传感器电子组件的插入装置致动，通过也使导电组分1320或导电插头1340在与导引器运动互补(complimentary)的方向上移动并从而开启该传感器电子设备，而触发图13A和13B所示的开关机构。在本公开的范围内，通过移动导电部分1320或导电插头1340激活传感器电子设备的过程可以包括单独的程序，其中在将传感器和传感器电子组件设置在皮肤表面上之后，将预定力施加在集成传感器和传感器电子组件的外壳上，以便可以获得导电部分1320或导电插头1340的期望运动。
图13C～13E示出在体贴片装置的电源开关机构的另一种配置，该电源开关机构包括导电衬垫，该在体贴片装置包括根据本公开实施例的传感器和传感器电子组件。参考图13C，可以提供暴露的导电环1371，其配置成与传感器电子设备中的电路板表面接触，以便该插入装置激活将导电环1371设置在电路板表面上以便完成该传感器电子组件的电接触(通过例如，在插入装置上手动施加力，将该导电环安置在与传感器电子设备的电路板接触的位置)。
参考图13D，在另一方面，电触头衬垫1372、1373可以提供给传感器电子组件中的电路板，以便该接触衬垫与导电环1371配合而开启传感器电子设备从而由其电源给该装置提供电能。图13E示出根据本公开的开关激活机构的又一种配置，其中选择性地设置和提供导电环1374的一部分从而在该装置中建立电接触。
如所讨论的，上述激活配置中的每个均包括电路与电源的断开部分，以便当不使用该装置时电源不被消耗，并在激活后使电触头的断开部分完整，从而给该装置提供电能并激活它使其运行。
图14示出在体贴片装置的电源开关机构，该电源开关机构包括利用推杆(push rod)激活的内部开关，该在体贴片装置包括根据本公开实施例的传感器和传感器电子组件。如图所示，在一个实施例中，推杆1410可以提供和设置在传感器电子设备中以便当在箭头1430所示方向上施加力时，推杆1410朝相同方向移动，并完成该两个触头1420、1421之间的电接触。在一方面，推杆1410可以提供在密封件1440如O-环或类似部件中。
图15示出根据本公开实施例的在体集成传感器和传感器电子组件的电源开关机构，该电源开关机构包括导引器回缩(retraction)触发器激活。如图所示，提供不导电针或装置1510从而从物理上分离两个电触头1520、1521。电触头1520、1521中的每个都被偏置或受弹簧力作用而被推向彼此并在物理上被不导电针1510分开。因此，当使不导电针1510在如箭头1530所示方向上从传感器电子组件中回缩或从其中撤回时，该两个电触头1520、1521配置成彼此接触，从而使电路的断开部分完整和建立电连接从而激活该传感器电子组件。
在一方面，该不导电装置或针1510可以包括，例如，但不局限于玻璃、塑料或适合于使该两个电触头分离并在其中提供绝缘的任何其它材料。
图16示出在体贴片装置的电源开关机构，该电源开关机构带有接触开关，该在体贴片装置包括根据本公开实施例的传感器和传感器电子组件。如图所示，在进一步方面，提供了电子开关1601(其配置成从传感器电子设备电源中引出不显著量(insubstantial amount)的电能)，并且在触发时，通过使两个触头1610、1611与激活部件1602物理接触而使触头1610、1611之间的断开部分完整，使传感器电子设备与其电源如电池的电路完整从而激活该装置用于运行。
图17A～17B示出在体贴片装置的电源开关机构，该电源开关机构带有电池接触锁定机构，该在体贴片装置包括根据本公开实施例的传感器和传感器电子组件。参考该图，在又一方面，该传感器电子设备的电池触头(battery contact)可以具有有缺口的垂片(barbed tab)1710。在制造后闲置模式中，当该装置不运行时，该垂片1710设置在传感器电子设备外壳内在图17A所示的位置中，以便它不与传感器电子设备电路板的导电触头1720接触。当在使用中如图17B所示时，可以使垂片1710偏置以便它与电路板上的导电触头1720物理接触，从而使来自/通往电池/电源的电路闭合，并从而激活或开启传感器电子设备。如该图所示，可以对垂片1710进行配置，以便在偏置后建立与导电触头1720的接触，它用导电触头1720和电路板锁定或紧固(latch)以便维持电连接。
图18A～18B示出在体贴片装置的电源开关机构，该电源开关机构具有双模态圆顶开关，该在体贴片装置包括根据本公开实施例的传感器和传感器电子组件。在又一方面，双模态圆顶形开关1810提供在传感器电子组件的电路板上，以便当被按下(如图18B所示)时，该圆顶形层1810(其可以包括例如薄片金属圆顶)可以配置成保持如图18B所示的凹形并可操作地使接触点1820处电路板上的电路闭合。在一方面，该圆顶形层1810可以配置成转向一边(shunt)从而使电路板接触点1820处的两个或多个电触头短路(short)。或者，圆顶形层1810可以连接到电路板上，以便该圆顶形层1810的一端与两个或多个开口电触头之一接触，并且圆顶形层1810的凹陷通过与开口电触头中其它的一个或多个触头物理接触而使电路板上的电路闭合。
以上述方式，根据本公开的各种实施例，提供了传感器电子设备激活开关配置，其可以被自动或半自动地触发或激活以响应于上述插入装置的激活，或者，可以由用户，例如压下提供在传感器电子设备外壳上的外壳或开关部分而分开地激活。因此，可以对传感器电子组件的电能消耗进行优化，同时在使用或激活之前提高该装置的制造后贮存寿命。
如上所述，在本公开某些方面，离散葡萄糖测量数据可以根据需要或要求从阅读器装置中获得，其中葡萄糖测量值是从经皮设置在患者或受验者皮肤层下并进一步具有保持在与皮肤层下间质液流体接触的传感器部分的体内葡萄糖传感器中获得的。因此，在本公开的方面中，该分析物监测系统的用户或患者可以使用如上所述的RFID通信协议方便地确定任何时候的实时葡萄糖信息。
以上述方式，根据本公开的各种实施例，每当期望测量时需要刺穿(lancing)或执行手指穿刺试验来获得离散葡萄糖测量值。所描述的分析物监测系统在进一步方面可以配置成登记或存储通过分析物传感器在预定或可编程时间段内或者在用户没有干预的情况下传感器的寿命内连续监测的葡萄糖数据，需要时可以在较晚的时间检索该数据。此外，可以提供输出指示如可听警报、可视警报或振动警报，从而通知用户预定状况，或当所监测到的葡萄糖水平偏离预定可接受范围时输出该指示(例如，低葡萄糖或高葡萄糖水平的警告指示)。
包括在软件应用程序执行环境下在包括在体贴片装置、传感器电子设备、阅读器装置、接收器单元、数据处理模块和/或执行上述一个或多个例行程序的远程终端在内的分析物监测系统中运行的过程的上述各种过程，可以具体化为利用面向对象语言形成的计算机编程，该面向对象语言允许带有模块化对象的复杂系统模型化从而创建代表真实世界、物理对象及其相互关系的抽象概念。实施本创造性过程所需软件可以存储在上面结合该图描述的分析物监测系统各种部件存储单元的记忆或存储装置中，包括在体贴片装置、阅读器装置、数据处理模块、各种描述的通信装置，或远程终端，该软件可由本领域技术人员开发并可以包括一种或多种计算机程序产品。
在又一方面，上述方法、装置和系统可以配置成登记和存储(例如，用适当的时间戳记和其它相关信息，例如同时期温度读数)从分析物传感器接收到的实时分析物数据，并可以配置成按需要通过利用例如装置如上面讨论的配置成与在体集成传感器和传感器电子组件通信的血糖计或控制器提供实时分析物数据。
就是说，在一个实施例中，在集成化在体传感器和传感器电子组件中，并在接收到来自另一个装置的请求后，连续或间歇地测量和存储与所监测分析物关联的实时数据，其中该另一个装置为，例如接收器单元或阅读器装置/接收器单元(例如，由用户操作)或任何其它可通信装置(如便携式电话、个人数字协助、iPhone、Blackberry装置、Palm装置如Palm Treo、Pro、Pre、Centro)，或者可用于在在体集成传感器和传感器电子组件被用户佩戴或使用时可从它获得期望的分析物数据的任何其它合适的可通信装置。在一方面，此种可通信装置可以设置在集成化在体传感器和传感器电子组件的预定接近范围内，并且当该可通信装置设置在预定接近范围内时，来自集成化在体传感器和传感器电子组件的数据可以传输到可通信装置。在一方面，此种数据通信可以包括感应耦合，利用例如电磁场、基于Zigbee协议的通信，或基于任何其它合适的接近范围的通信技术。以这种方式，可以提供葡萄糖按需模式以便按用户需要将与同时监测的分析物水平信息关联的信息提供给用户。
以这种方式，在本公开的实施例中，通过例如利用安全地设置和粘接到用户皮肤表面上的无源和有源表面支架装置的柔性或刚性灌封(potted)或低压/低温包覆成型电路，优化该在体传感器电子设备的大小和尺寸使其变小。当柔性电路利用包覆成型或在包覆成型中时，该传感器电子设备可以包括分析物传感器和/或该柔性电路上的其它生理条件检测传感器。此外，在本公开实施例中，一种或多种印刷的RF天线可以提供在传感器电子电路内以便与一个或多个远程装置进行RF通信，并且进一步地，该装置操作和/或功能可以被编程或利用一个或多个微处理器，或特定用途集成电路(ASIC)加以控制从而降低内部部件的数目。
本公开实施例包括直接封装集成电路或传感器电子部件的一种或多种低压模塑材料。利用低压模塑材料封装所需的热过程可以配置成保护热敏部件如分析物传感器或传感器电子设备的其它部件不受热包覆成型过程产生的热影响。可以使用其它技术如注射模塑和/或灌封。
在另一方面，该传感器电子设备可以利用光学技术如用例如UV固化材料或利用两种光子吸收材料进行模塑，其也可以用于减少该装置外壳内传感器电子设备周围的死体积或未使用体积以便减小该传感器电子设备的大小和尺寸。而且，该传感器电子设备配置成通过例如包括可配置成执行离散部件如稳压器、数据处理/存储、热电偶/热敏器、RF通信数据包产生器等的一种或多种功能的特定用途集成电路(ASIC)，而减少部件数目。另外，除了可以使用传感器电子设备中的ASIC减小在体装置尺寸之外，还可以使用现场可编程逻辑闸阵列(FPGA)或任何其它合适的装置。
而且，本公开实施例包括可由柔性电路制造并与传感器电子设备一起集成到该装置外壳中作为单一集成装置的分析物传感器。柔性电路实例可包括在聚酯层上蒸发或喷涂的金、在聚酰胺柔性电路上的单层或多层铜或金。当由铜或金聚酰胺柔性电路制造传感器时，金或其它惰性材料可以选择性地镀在该电路可植入部分上从而将铜的腐蚀减到最小。在本公开的方面，该柔性电路可以通过钢模切割或激光切割，或替换地化学铣切从而限定来自该柔性电路辊的传感器。
本公开实施例的进一步配置包括RF通信模块，其提供在柔性电路上的而不是作为传感器电子设备中的单独部件。例如，通过例如使外壳内传感器电子部件围绕在柔性电路上，或折叠在该部件上，以及与该电子部件一起封装在该装置外壳内，可以将该RF天线直接提供在该柔性电路上。
根据本公开的实施例，可以利用插入装置将集成传感器和传感器电子组件设置在用户皮肤表面上。例如，可以提供自动或半自动的、弹性偏置的和/或手动的插入装置，从而部署该传感器和传感器电子设备以便将该传感器可植入部分设置成与用户分析物如间质液流体接触，同时将传感器电子设备外壳安全地设置和粘接在皮肤表面上。在本公开实施例中，通过插入装置部署该集成组件后，该传感器电子设备(例如，分析物监测系统的传输器单元)可以(从待用、闲置模式)切换到运行状态或状况。
在一方面，集成传感器和传感器电子组件可以预先装载或以其它方式预先组装在插入装置中，以便当使用时，用户可以仅通过操作插入装置就可以部署该集成传感器和传感器电子组件，而不需要在部署之前将该集成组件与插入装置耦接。
在一方面，该集成传感器和传感器电子组件以及插入装置可以作为一个单一装置而灭菌和封装并提供给用户。此外，在制造期间，该插入装置组件可被终端封装(terminal packaged)，节省了开支并避免了例如昂贵的热成型托盘(thermoformed tray)或箔密封件的使用。另外，该插入器装置可以包括端盖，该端盖可旋转地耦接到插入装置体并为与集成组件一起提供在插入装置内的传感器提供了安全无菌环境(并避免了供传感器用的干燥剂)。而且，用该端盖密封的插入装置配置成从装运期间的显著运动开始将该传感器保留在外壳内，以便从制造、组装和装运直至该装置已为用户使用做好准备位为止一直保持该传感器相对于该集成组件和插入装置的位置。
而且，如上所述，本公开实施例中的插入装置包括用于辅助通过用户皮肤层经皮插入传感器的尖针或导引器。该尖针或导引器可以配置成在部署之后在插入装置外壳内回缩从而允许诸如倾斜或角运动(angledmovement)的运动，从而将传感器电子设备外壳上的粘接剂设置在用户皮肤表面上，而不需要涉及此种运动的导引器。而且，通过在插入后将导引器保留在插入装置外壳中，所用导引器的处置可能更安全，而不存在可能的生物危害方面的忧虑。
而且，在本公开实施例中，在使用插入装置设置传感器和传感器电子设备之前、过程中和之后，该尖针或导引器是用户不可见的。因此，可以将与尖针可见情况下的自觉疼痛潜在性减到最小。
在进一步实施例中，该插入装置可以利用导引器的弹性偏置或自动回缩进行手动部署。就是说，对于传感器插入，用户可以在插入装置外壳上施加预定量的压力从而插入导引器和传感器，所施加的压力足以穿过用户皮肤层，并且如此配置该装置外壳以便所施加的压力或导引器所行进的距离是预定的(例如，通过使用阻挡器(stopper)或插入装置内壁中的突起部，其可操作地阻挡或阻断导引器在已到达预定距离之后朝着皮肤透入方向进一步向下运动)。在一方面，所施加的压力经配置也可以向下按提供在插入装置外壳内的弹簧或偏置机构，当释放所施加的压力时，该导引器通过来自弹簧或偏置机构的回弹力自动回缩到其在插入装置外壳内的原始预部署位置。
以这种方式，安置分析物传感器可以获得一致且可重复的插入深度。此外，由于为导引器回缩力提供的偏置弹簧可以处在预部署状态、未偏置状态和松弛状态，所以该插入装置外壳(例如，塑料或者塑料和金属外壳的组合物)可能不在弹簧张力的应力下。
在进一步实施例中，可以沿着与用户皮肤表面接触设置的插入装置其它外围提供双面粘接剂层，以便粘接到用户皮肤层后除了增强该材料的舒适性和透气性外，还可以在传感器设置过程之前和期间适当地排列和设置导引器、传感器和传感器电子组件。
在一个实施例中，集成化分析物监测装置组件可以包含通过皮肤层经皮设置并在预定时间段内保持与皮肤层下间质液流体接触的分析物传感器，该分析物传感器具有近端部分和远端部分，它还包含耦接到分析物传感器上的传感器电子设备，该传感器电子设备包含具有导电层和设置在导电层上的传感器天线的电路板、提供在该电路板上并与分析物传感器的近端部分耦接从而维持连续电通信的一个或多个电触头，以及提供在该电路板上并与分析物传感器信号通信的数据处理部件，该数据处理部件配置成执行用于处理从分析物传感器接收到的信号的一个或多个例行程序，该数据处理部件配置成利用传感器天线控制与从分析物传感器接收到的处理信号关联的数据到远程位置的传输以响应于从该远程位置接收到的请求信号。
该分析物传感器的近端部分和电路板可以封装。
该分析物传感器的近端部分和电路板用灌封材料封装。
该电路板可以包括上层和下层，其中该导电层设置在该上层和下层之间。
该天线可以包括回路天线或偶极天线。
该天线可以印在导电层上。
在一方面，该组件可以包括耦接到电路板导电层上的传感器天线上的多个感应部件。
该多个感应部件可以串联耦接到传感器天线上。
该多个感应部件可以基本上围绕电路板外边缘设置。
该电路板可以基本是圆形的，并且该多个部件可以围绕该圆形电路板外圆周设置。
该多个感应部件中的每个都可以彼此基本等间距地设置在该电路板上。
而且，该组件可以包括向传感器电子设备提供电能的电源。
该数据处理部件可以包括设置在该电路板上并配置成处理来自分析物传感器的信号的特定用途集成电路(ASIC)。
该数据处理部件可以包括状态机。
该状态机可以配置成执行用于处理从该分析物传感器接收到的信号的一种或多种编程或可编程逻辑。
该分析物传感器可以包括葡萄糖传感器。
在另一个实施例中，分析物数据采集装置可以包含配置成基于载波信号产生控制命令的控制单元、耦接到控制单元从而传输带有载波信号的控制命令和利用该载波信号接收后向散射响应数据包的天线部分，以及耦接到该天线部分和控制单元上从而处理所接收到的后向散射响应数据包和产生输出葡萄糖数据的接收器单元。
该控制单元可以包括耦接到振荡器并配置成产生RF电能的信号谐振器。
该信号谐振器可以包括表面声波振荡器。
所产生的RF电能和控制命令可以利用载波信号传输。
该控制命令可以包括利用载波信号传输到远程位置的RF控制命令。
当该天线设置在与该远程位置相距距离不大于约10英尺的位置上时，可以从该远程位置接收后向散射响应数据包。
该天线可以设置在距离该远程位置五英尺或更小的位置上。
该天线部分可以包括回路天线或偶极天线中的一个或多个。
该控制单元可以配置成产生载波信号。
该接收器部分可以包括对所接收到的后向散射响应数据包进行滤波的滤波器。
进一步方面可以包括可操作地耦接到控制单元从而输出与所产生的葡萄糖数据对应的指示的输出单元。
该输出的指示可以包括可视输出、可听输出、振动输出中的一种或多种，或其一种或多种组合。
该控制单元可以在成功接收后向散射响应数据包后产生接收确认信号。
所产生的接收确认信号可以输出给用户。
在另一方面，该装置可以进一步包括耦接到控制单元从而存储所产生的控制命令、载波信号，所接收到的后向散射响应数据包、所产生的输出葡萄糖数据，或其一种或多种组合的存储装置。
该存储装置可以包括非易失性存储装置。
该控制单元可以包括微处理器。
该控制单元可以包括特定用途集成电路。
又一方面可以包括用于容纳体外血糖测试条的条端口，该条端口包括与控制单元信号通信的电连接。
该控制单元可以配置成处理测试条上的样品从而确定对应的葡萄糖水平。
在另一个实施例中，集成化分析物监测装置可以包含传感器电子组件，其包括分析物传感器、电源、可操作地耦接到该电源和该分析物传感器上的激活开关、与该分析物传感器和激活开关电接触，具有一个或多个存储在其中用于执行的编程指令的控制器单元，该控制器单元配置成在激活开关被触发时处理从该分析物传感器接收到的一种或多种信号，还包括插入装置，该插入装置包含外壳、耦接到外壳上，配置成在第一位置和第二位置之间移动的导引器和可操作地耦接到外壳上，配置成自动地使该导引器从第二位置回缩到第二位置的偏置机构。
在导引器从第一位置移到第二位置之前，该传感器电子组件可以完全保留在插入装置外壳内。
在该导引器到达第二位置之前，该激活开关将不被触发。
该分析物传感器可以包括葡萄糖传感器。
在导引器已到达第二位置之后并在该导引器从第二位置回缩到第一位置之前，该激活开关可以被触发。
该导引器在从第一位置移到第二位置的过程中可以与分析物传感器接合，进一步地，该导引器在从第二位置移到第一位置的过程中可以与该分析物传感器脱离。
该导引器从第一位置移到第二位置的移动可以是对手动施加在外壳上力的响应。
该偏置机构可以包括弹簧。
进一步方面可以包括提供在外壳底表面上以便安置在皮肤层上的粘接剂层。
该粘接剂层可以配置成将该传感器电子组件保留在皮肤层上一段预定的时间。
该电源可以包括使用一次的一次性电池。
该电源的有效运行寿命可以超过该分析物传感器的有效运行寿命。
而且，一方面可以包括配置成与插入装置外壳开口端匹配的盖子。
当该盖子与该外壳耦接时，该外壳内部空间可以保持在基本上无污染物的环境中。
该传感器电子组件可以包括印刷电路板，其包括永久地连接到其上的分析物传感器部分。
该控制器单元可以包括特定用途集成电路(ASIC)。
该导引器在第一位置和第二位置之间的移动可以为与皮肤表面成约90度或更小的角的移动。
该传感器电子组件可以包括高度小于约4mm的外壳。
在不背离本公开实施例的范围和精神的前提下，对于本领域技术人员来说，对本公开的结构和操作方法的各种其它修改和改变将是显而易见的。尽管已结合具体实施例对本发明公开内容进行了说明，但是应理解本发明要求保护的内容不应过度地受限于此种具体实施例。所附权利要求旨在限定本公开的范围，并借此涵盖了处于这些权利要求及其等价形式的范围内的结构和方法。

Claims (10)

1.一种集成化分析物监测装置组件，包括：
通过皮肤层经皮设置并在预定时间段内保持与所述皮肤层下间质液流体接触的分析物传感器，所述分析物传感器具有近端部分和远端部分；和
耦接到所述分析物传感器上的传感器电子设备，所述传感器电子设备包括：
具有导电层和设置在所述导电层上的传感器天线的电路板；
提供在所述电路板上并与所述分析物传感器的近端部分耦接从而维持连续电通信的一个或多个电触头；和
提供在所述电路板上并与所述分析物传感器信号通信的包括特定用途集成电路(ASIC)的数据处理部件，所述数据处理部件配置成执行用于处理从所述分析物传感器接收到的分析物数据的一个或多个例行程序，所述数据处理部件配置成响应从远程位置接收到的请求信号，利用所述传感器天线控制从所述分析物传感器接收到的所述分析物传输到所述远程位置；
其中所述分析物传感器通过所述皮肤层经皮设置之前所述传感器电子设备耦接至所述分析物传感器；以及进一步
其中所述分析物传感器通过所述皮肤层经皮设置之前所述传感器电子设备包括构造成容纳导引器的外壳单元。
2.根据权利要求1所述的组件，其中，所述分析物传感器的近端部分和所述电路板是封装的。
3.根据权利要求2所述的组件，其中，所述分析物传感器的近端部分和所述电路板用灌封材料封装。
4.根据权利要求1所述的组件，其中，所述电路板包括上层和下层，其中所述导电层设置在所述上层和所述下层之间。
5.根据权利要求1所述的组件，其中，所述天线包括回路天线或偶极天线。
6.根据权利要求1所述的组件，其中，所述电路板基本是圆形的。
7.根据权利要求1所述的组件，包括向所述传感器电子设备提供电能的电源。
8.根据权利要求1所述的组件，其中，所述数据处理部件包括状态机。
9.根据权利要求8所述的组件，其中，所述状态机配置成用于执行用于处理从所述分析物传感器接收到的分析物数据的一种或多种编程或可编程逻辑。
10.根据权利要求1所述的组件，其中，所述分析物传感器包括葡萄糖传感器。
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