CN101686804A - 健康监控器 - Google Patents

健康监控器 Download PDF

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CN101686804A
CN101686804A CN200880021299A CN200880021299A CN101686804A CN 101686804 A CN101686804 A CN 101686804A CN 200880021299 A CN200880021299 A CN 200880021299A CN 200880021299 A CN200880021299 A CN 200880021299A CN 101686804 A CN101686804 A CN 101686804A
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data
monitoring system
blood glucose
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glucose monitoring
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CN101686804B (zh
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丹尼尔·伯恩斯坦
贾里德·瓦特金
马丁·J·芬内尔
马克·K·斯隆
迈克尔·洛夫
纳穆瓦尔·基亚叶
让-皮埃尔·科尔
史蒂夫·斯科特
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Therasense Inc
Abbott Diabetes Care Inc
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—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
    • A61B5/14532—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 for measuring glucose, e.g. by tissue impedance measurement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0015—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by features of the telemetry system
    • A61B5/002—Monitoring the patient using a local or closed circuit, e.g. in a room or building
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    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—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
    • A61B5/1468—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 chemical or electrochemical methods, e.g. by polarographic means
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—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
    • 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
    • A61B5/14865—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 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
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    • A61B5/145—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
    • A61B5/1495—Calibrating or testing of in-vivo probes
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    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B2560/04—Constructional details of apparatus
    • A61B2560/0443—Modular apparatus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/04—Constructional details of apparatus
    • A61B2560/0443—Modular apparatus
    • A61B2560/045—Modular apparatus with a separable interface unit, e.g. for communication
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/04—Constructional details of apparatus
    • A61B2560/0456—Apparatus provided with a docking unit
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/04—Constructional details of apparatus
    • A61B2560/0475—Special features of memory means, e.g. removable memory cards
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0015—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by features of the telemetry system
    • A61B5/0017—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by features of the telemetry system transmitting optical signals

Abstract

本发明提供了检测体液中的分析物的方法和设备。本公开的实施例包括增强的分析物监控设备和系统。

Description

健康监控器
优先权
本申请要求2007年6月21日提交的标题为“Health Monitor”的美国临时申请No.60/945,581的优先权，其公开内容包括在此以供参考。
背景技术
检测某些个体中分析物的水平，如葡萄糖、乳酸、氧等等对于这些个体的健康是非常重要的。例如，监控葡萄糖对患有糖尿病的个体特别重要。糖尿病患者可能需要监控葡萄糖水平从而确定何时需要胰岛素以降低体内的葡萄糖水平或何时需要补充葡萄糖以增加体内的葡萄糖水平。
因此，需要允许用户测试一种或多种分析物的设备、系统和方法。
发明内容
本发明实施例包括增强的体外分析物测试仪(meter)和系统，其具有增强的体内连续分析物监控功能。为了方便起见，这里的描述说明了体外分析物葡萄糖测试仪主要作为体外血糖(“BG”)测试仪，而体内连续分析物系统主要作为体内连续葡萄糖(“CG”)监控设备和系统。这样的描述绝非为了以任何方式限制本公开的范围。
因此，本发明提供了具有高级功能的BG测试仪和系统。每个BG或CG系统可接收和处理来自其自身的各系统和/或来自其他系统的数据，例如，BG系统可接收和处理CG系统数据，反之亦然。本发明实施例能够将CG数据通过BG测试仪提供给用户。
本发明实施例对多数时间可能需要传统血糖BG数据而可能周期性地需要CG数据的用户是有用的。过去解决该问题的一种方式是为用户提供BG测试仪和CG系统。然而，这有成本方面的缺点，因为CG系统可能比BG测试仪更贵，且增加了用户必须学习如何使用这两种测试仪的培训-BG测试仪用于普通用途，而CG测试仪用于需要CG数据的时候。
本发明实施例对于I型和II型糖尿病患者、经受糖尿病症状的其他病人、或处于手术后恢复期的病人都是适合的。
还提供了设备，方法和套件(kits)。
附图说明
图1示出根据本公开的数据监控和管理系统的实施例的方框图；
图2示出图1中数据监控和管理系统的发射器单元实施例的方框图；
图3示出图1中数据监控和管理系统的接收器/监控器单元实施例的方框图；
图4示出根据本公开的分析物传感器实施例的示意图；
图5A-5B分别示出分析物传感器的另一实施例的透视图和截面图；
图6示出包括CG数据记录器(logger)(例如包括数据存储装置或存储器)和增强的BG测试仪的系统的示例性实施例，其中CG数据记录器能够将由至少部分设置在用户皮肤表面下的CG分析物传感器获得的CG数据传输至增强的BG测试仪；
图7示出模块系统的示例性实施例，其包括具有发射器的CG单元、数据传输模块和增强的BG测试仪，其中CG单元能够将由至少部分设置在用户皮肤表面下的CG分析物传感器获得的数据通过数据传输模块无线传输至增强的BG测试仪；
图8示出集成电路的示例性实施例，包括增强的BG测试仪和具有发射器的CG单元，其中CG单元能够将由至少部分设置在用户皮肤表面下的CG分析物传感器获得的CG数据实时传输至增强的BG测试仪；
图9示出系统的示例性实施例，其包括BG测试仪和对接单元(docking unit)，这里示出的是被配置为皮带套(belt holster)；
图10A-10C示出葡萄糖测试条(test strip)的示例性实施例，其可与这里所述的增强系统一起使用；以及
图11A-11C示出示例性BG测试仪。
具体实施方式
在描述本公开之前，应该理解本公开不限于这里所述的具体实施例，这些实施例当然可以变化。还可以理解这里所用的术语仅是为了说明具体实施例的目的，而不是为了限制，因为本公开的范围将仅由所附权利要求限定。
可以理解，在提供值的范围时，除非上下文明确指出，否则在该范围和任何其他指出的范围的上限和下限之间，每个居间值到下限单位的十分之一，或该所述范围内的居间值都包括在本公开内。可独立包括在较小范围内的这些较小范围的上下限也包括在本公开内，受所述范围内任何特别排除界限的影响。所述范围包括这些界限中一个或两个时，除这些所包括界限中任一或两个之外的范围也包括本公开内。
必须指出，如这里和所附权利要求中的使用，单数形式“一(a)”，“一(an)”和“该(所述)(the)”包括多个所指对象，除非上下文明确指出不同。
本领域技术人员在阅读本公开后可显然看出，这里所述和所示的每个单独实施例具有独立的组件和特征，其易于与其他几个实施例中的任一个的特征分开或结合而不偏离本公开的范围或精神。
这里所示的图不必按比例示出，为了清楚起见，某些组件和特征被夸大。
实施例包括允许糖尿病患者测量血液(或其他体液)葡萄糖水平的设备，如手持式电子测试仪(血糖测试仪)，如可从加利福尼亚Alameda的Abbott Diabetes Care公司获得的
Figure G2008800212991D00041
或
Figure G2008800212991D00042
血糖监控系统，其可经酶基测试条接收血样。通常，用户将测试条插入测试仪并切开手指或替换身体部位从而获得血样。抽取的血样被应用到测试条且测试仪读取测试条并确定分析物浓度，然后将浓度传达给用户。例如，血糖测试仪将测试条中酶反应产生的电流转化为相应的血糖值，该血糖值被显示或以其他方式提供给病人从而示出测试时的葡萄糖水平。
这种周期性的独立葡萄糖测试帮助糖尿病患者采取任何必要的校正措施从而更好地管理糖尿病症状。
测试条可适于测试任何体积的样品中的分析物浓度，包括但不限于小体积的样品，如约1微升或更少的样品，例如约0.5微升或更少，例如约0.3微升或更少，例如约0.1微升或更少。在某些实施例中，样品的体积可以低至约0.05微升或低至约0.03毫升。可配置测试条，以便可利用全部或部分填充测试条样品室(samplechamber)的样品体积获得精确的分析物测试。在某些实施例中，测试可仅在足够样品应用到测试条上时开始，如通过诸如电极的检测器检测的那样。可对系统编程从而允许在首次应用不足的样品时再应用额外的样品，如再应用样品的时间范围可在约10秒到约2分钟之间，例如从约30秒到约60秒。
测试条可侧边填充、前面填充、顶部填充或角部填充，或其中的任何组合。测试条可不用校准，如要求用户最小输入(如果有)来校准。在某些实施例中，可采用无需校准的测试条。在这样的实施例中，用户不必采取任何校准措施，即用户看不到校准。
如上所述，测试条可与测试仪一起使用。在某些实施例中，测试仪可以是集成的测试仪，即，具有至少一个测试条和至少一个第二元件的设备，如测试仪和/或设备中的皮肤刺穿元件，如刺血针(lancet)等。在某些实施例中，测试条可与测试仪和刺血针集成到一起，如在单个外壳中。在一个设备中具有集成的多个元件减少了获取分析物水平所需的设备的数目并促进了采样过程。例如，实施例可包括这样的外壳，其包括一个或多个分析物测试条、皮肤刺穿元件和处理器，以便确定应用到测试条上的样品中的分析物浓度。多个测试条可保持在外壳内部的存放盒(magazine)中，并且用户操作时，可从存放盒中分发单个测试条以便至少一部分延伸出外壳供使用。
测试条可以是短测试时间测试条。例如，测试时间的范围可在约1秒到约20秒范围内，如约3秒到约10秒，如约3秒到约7秒，如约5秒或约3秒。
示例性测试仪和测试条及其使用在图10A-10C和图11A-11C中示出。
实施例包括分析物监控设备和系统，其包括分析物传感器-至少一部分可设置在用户皮肤下面，以便体内检测体液中的至少一种分析物，如葡萄糖、乳酸等。这类体内传感器在这里通常被称为体内传感器/系统和/或连续传感器/系统，除非另外指出，否则这些术语可互换使用。实施例包括完全可植入分析物传感器和分析物传感器，在分析物传感器中，仅一部分传感器设置在皮肤下面，且一部分传感器位于皮肤上面，如为了连接到发射器、接收器、收发器、处理器等等。传感器可以是例如，皮下可植入到病人身体以便连续或周期性地监控病人组织间液(interstitial fluid)中的分析物水平。为了本说明的目的，连续监控和周期性监控可互换使用，除非另外指出。传感器响应可关联和/或转换为血液或其他流体中的分析物水平。在某些实施例中，分析物传感器可设置成与组织间液接触从而检测葡萄糖水平，所检测的葡萄糖可用来推断病人血流中的葡萄糖水平。分析物传感器可插入到静脉、动脉或其他含流体的身体部位。本公开的分析物传感器的实施例可配置成监控一定时间段的分析物水平，该时间段范围可在几分钟、几小时、几天、几周或更长时间。也可考虑不需要与体液接触的分析物传感器。
所考虑的分析物传感器，如葡萄糖传感器，能够体内检测分析物约一小时或更长，如约几个小时或更长，如约几天或更长，如约三天或更长，如约五天或更长，如约七天或更长，如约几周或至少一个月。未来分析物水平可基于所获得的信息来预测，如时间t0时的当前分析物水平、分析物的变化速率等。预测性警报可将预测的分析物水平通知用户，这在用户分析物水平达到未来水平前是有意义的。这样就为用户提供了采取校正措施的机会。
图1示出根据某些实施例的数据监控和管理系统，例如分析物(如葡萄糖)监控系统100。本公开实施例的进一步描述主要针对葡萄糖监控设备和系统、以及葡萄糖检测方法，这仅是为了便利，且这样的描述绝不是为了限制本公开的范围。可以理解，分析物监控系统可配置成在同一时间或不同时间监控不同的分析物。
可监控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(如CK-MB)、肌氨酸、肌氨酸酐、DNA、果糖胺、葡萄糖、谷酰胺、生长激素、激素、酮体、乳酸、过氧化物、前列腺特异性抗原、凝血素、RNA、促甲状腺激素、以及肌钙蛋白。还可监控药物的浓度，如抗生素(如庆大霉素、万古霉素等等)、洋地黄毒苷、异羟洋地黄毒苷、滥用药物、茶碱、以及杀鼠灵。在监控一种以上分析物的那些实施例中，分析物可在同时或不同时间被监控。
分析物监控系统100包括传感器101、可连接到传感器101的数据处理单元102、配置成经通信线路103与数据处理单元102通信的主接收器单元104。在某些实施例中，主接收器单元104可进一步配置成传输数据到数据处理终端105，从而评估或以其他方式处理或格式化主接收器单元104接收的数据。数据处理终端105可配置成经可选地配置成双向通信的通信线路直接从数据处理单元102接收数据。进一步，数据处理单元102可包括发射器或收发器，从而传输数据到主接收器单元104和/或数据处理终端105和/或可选的副接收器单元106，和/或从它们接收数据。
图1还示出可选的副接收器单元106，其可操作地耦接到通信线路并配置成接收从数据处理单元102发送的数据。副接收器单元106可配置成与主接收器单元104以及数据处理终端105通信。副接收器单元106可配置成与主接收器单元104和数据处理终端105中的每一个双向无线通信。如下面进一步的详细讨论，在某些实施例中，副接收器单元106与主接收器相比可以是去特征的接收器(de-featured receiver)，即，与主接收器单元104相比，副接收器可包括有限的或最小数目的功能和特征。这样，副接收器单元106可包括较小的(在一个或更多维度上，包括所有的维度)、紧凑的外壳或嵌入到设备中，如腕表、臂环(arm band)等。可替换地，副接收器单元106可配置有与主接收器单元104相同或基本类似的功能和特征。副接收器单元106可包括要与对接座(docking cradle)单元匹配的对接部分，以便设置在床边供夜间监控，和/或包括双向通信设备。对接座可为电源充电。
图1中所示的分析物监控系统100的实施例中仅示出了一个传感器101、数据处理单元或控制单元102和数据处理终端105。然而，本领域技术人员可以理解分析物监控系统100可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。多个传感器可设置在病人体内供同时或不同时间的分析物监控。在某些实施例中，通过首先设置的传感器获得的分析物信息可用来与通过第二传感器获得的分析物信息进行比较。这对确认或验证从一个或两个传感器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分析物信息，则这类冗余是有用的。在某些实施例中，第一传感器可用来校准第二传感器。
分析物监控系统100可以是连续监控系统、或半连续、或离散监控系统。在多组件环境中，每个组件可配置成由系统中的一个或更多其他组件唯一识别，从而易于解决分析物监控系统100中不同组件间的通信冲突。例如，可使用唯一ID、通信信道等。
在某些实施例中，传感器101物理设置在分析物水平被监控的用户身体内或身体上。传感器101可配置成至少周期性地采样用户的分析物水平并将采样后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，因此两个设备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。数据处理单元可包括固定元件，如粘接剂等，从而将其固定到用户身体。可使用可连接到用户并可与单元102匹配的支架(mount)。例如，支架可包括粘接剂表面。数据处理单元102执行数据处理功能，这里这类功能可包括但不限于对数据信号放大、滤波和编码，每个功能都相应于用户的采样后的分析物水平，从而经通信线路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或组合的传感器/数据处理单元可全部植入到用户皮层下面。
在某些实施例中，主接收器单元104可包括包含RF接收器和配置成通过通信线路103与数据处理单元102通信的天线的模拟接口部件、以及用于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、数据位恢复等等，或其中的任何组合。
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从数据处理单元102发送的与通过传感器101检测的被监控的分析物水平相关的信号。
再参考图1，数据处理终端105可包括个人计算机、便携式计算机，如膝上型或手持式设备(如各人数字助理(PDA)、诸如便携式电话的电话(如多媒体和可上网移动电话，如iPhone或类似的电话)、mp3播放器、传呼机等)、药物输送设备，这些设备中的每一个都可配置成经有线或无线连接与接收器进行数据通信。此外，数据处理终端105可进一步连接到数据网络(未示出)，以便存储、检索、更新、和/或分析相应于检测的用户分析物水平的数据。
数据处理终端105可包括输液设备，如胰岛素注射器等，其可配置成将胰岛素给予病人，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。可替换地，主接收器单元104可配置成将输液设备集成到其中，以便主接收器单元104配置成对病人给予胰岛素(或其他适当的药物)治疗，例如执行或修改基本分布(profile)、以及尤其根据从数据处理单元102接收的检测的分析物水平来确定服用适当的药物。输液设备可以是外部设备或内部设备(完全可植入到用户身体内)。
在某些实施例中，可包括胰岛素注射器的数据处理终端105可配置成接收来自数据处理单元102的分析物信号，且因此结合有主接收器单元104的功能，包括数据处理以便管理病人的胰岛素治疗和分析物监控。在某些实施例中，如图1所示的通信线路103以及一个或多个其他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IIIPPA要求)，同时避免潜在的数据碰撞和干扰。
图2示出了图1中所示的数据监控和检测系统的数据处理单元实施例的方框图。可包括用户输入和/或接口组件，或者数据处理单元可没有用户输入和/或接口组件。在某些实施例中，一个或多个专用集成电路(ASIC)可用来执行一种或多种与使用例如一个或更多状态机器和缓存器的数据处理单元(和/或接收器单元)的操作关联的功能或程序。图2中所示的处理器可装配有足够的存储器，从而在延长的时间段上从一至几个样品到几天到几周的整个使用周期上获得的大量样品范围内，存储感兴趣的数据(如分析物数据)。一个方面，所包括的存储器可作为处理器204的一部分。在另一个实施例中，独立的存储器单元(如存储器芯片)、随机存取存储器(RAM)或任何其他存储设备用于存储后续的检索数据。例如，如图所示，数据处理单元可包括可操作地耦接到处理器204的存储单元215，并配置成存储所接收的分析物数据，例如从传感器101接收的数据(图1)。一个方面，存储单元215可配置成存储在预定时间段上从传感器接收的大量数据，且处理器204可配置成在限定的时间段上收集和存储数据后在单个或多个数据传输中以批量方式传输所存储的分析物传感器数据。在另一个方面，处理器204可配置成使得所接收的分析物传感器数据在从分析物传感器接收时被实时传输。
而且，处理器204可配置成预期或等待来自数据传输接收方的接收确认信号(例如图1中的接收器单元104)，这里当没有收到信号接收确认信号时，例如，数据处理单元102的处理器204可配置成检索所存储的分析物传感器数据并再次将其发送给接收器单元104。
如从图2中实施例看到的，传感器单元101(图1)包括四个触点，其中3个是电极-工作电极(W)210、参考电极(R)212、对立电极(C)213，每个电极都可操作地耦接到数据处理单元102的模拟接口201。该实施例还示出了可选的保护触点(G)211。可采用更少或更多的电极。例如，对立电极和参考电极的功能可由单个对立/参考电极执行，可以有一个以上的工作电极和/或参考电极和/或对立电极等。
图3是接收器/监控器单元实施例的方框图，诸如图1中所示的数据监控和管理系统的主接收器单元104。主接收器单元104包括一个或多个下列部件：血糖测试条接口301、RF接收器302、输入303、温度检测部件304、以及时钟305，每个部件都可操作地耦接到处理和存储部件307。主接收器单元104还包括可操作地耦接到功率转换和监控部件308的电源306。进一步，功率转换和监控部件308还耦接到接收器处理器307。而且，还示出了接收器串行通信部件309、以及输出310，每个部件都可操作地耦接到处理和存储单元307。接收器可包括用户输入和/或接口组件或者可没有用户输入和/或接口组件。
在某些实施例中，测试条接口301包括葡萄糖水平测试部，以便接收血液(或其他体液样品)葡萄糖测试或与其相关的信息。例如，该接口可包括测试条端口以接收葡萄糖测试条。该设备可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310上显示(或以其他方式告知)葡萄糖水平。可采用任何合适的测试条，如仅需要施加非常少量的(如一毫升或更少，如0.5毫升或更少，如0.1毫升或更少)样品到测试条以便获得精确的葡萄糖信息的测试条，例如Abbott Diabetes Care公司的
Figure G2008800212991D00121
血糖测试条。通过体外葡萄糖测试设备获得的葡萄糖信息可用于不同目的、计算等。例如，该信息可用于校准传感器101，确认传感器101的结果从而增加其可信度(如传感器101获得的信息被用于治疗相关的决策的情形)等。
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/或副接收器单元105、和/或数据处理终端/输液部件105可配置成经通信线路无线地接收来自例如血糖测试仪的血糖值。在进一步实施例中，用户操纵或使用分析物监控系统100(图1)可手动输入血糖值，例如使用包含在数据处理单元102、主接收器单元104、副接收器单元105的一个或多个中、或者数据处理终端/输液部件105中的用户接口(例如，键盘、小键盘、语音命令等等)。
可采用的测试条、血糖(BG)测试仪以及连续监控系统和数据管理系统的实施例的其他详细描述在下面但不限于下面的文献中提供：美国专利No.6,175,752、美国专利No.6,560,471、美国专利No.5,262,035、美国专利No.6,881,551、美国专利No.6,121,009、美国专利No.7,167,818、美国专利No.6,270,455、美国专利No.6,161,095、美国专利No.5,918,603、美国专利No.6,144,837、美国专利No.5,601,435、美国专利No.5,822,715、美国专利No.5,899,855、美国专利No.6,071,391、美国专利No.6,120,676、美国专利No.6,143,164、美国专利No.6,299,757、美国专利No.6,388,790、美国专利No.6,377,894、美国专利No.6,600,997、美国专利No.6,773,671、美国专利No.6,514,460、美国专利No.6,592,745、美国专利No.5,628,890、美国专利No.5,820,551、美国专利No.6,736,957、美国专利No.4,545,382、美国专利No.4,711,245、美国专利No.5,509,410、美国专利No.6,540,891、美国专利No.6,730,200、美国专利No.6,764,581、美国专利No.6,299,757、美国专利No.6,461,496、美国专利No.6,503,381、美国专利No.6,591,125、美国专利No.6,616,819、美国专利No.6,618,934、美国专利No.6,676,816、美国专利No.6,749,740、美国专利No.6,893,545、美国专利No.6,942,518、美国专利No.6,514,718、2003年12月26日提交的标题为“Continuous Glucose MonitoringSystem and Methods of Use”的美国专利申请No.10/745,878，并且这里，每个上述专利的公开内容结合于此仅供参考。
图4示意地示出根据本公开的分析物传感器的实施例。该传感器实施例包括底座404上的电极401、402和403。电极(和/或其他特征)可用任何合适的技术施加或以其他方式处理，如化学气相沉积(CVD)、物理气相沉积、溅射、反应溅射、印刷、涂覆、烧蚀(激光烧蚀)、涂刷、浸涂、蚀刻等等。材料包括但不限于铝、碳(如石墨)、钴、铜、镓、金、铟、铱、铁、铅、镁、汞(作为汞合金)、镍、铌、锇、钯、铂、铼、铑、硒、硅(如掺杂的多晶硅)、银、钽、锡、钛、钨、铀、钒、锌、锆、其混合物、以及合金、氧化物、或这些元素的金属化合物。
传感器可完全植入到用户身体内或可配置成使得仅一部分设置在用户身体内(内部)而其他部分在用户身体外(外部)。例如，传感器400可包括可设置在皮肤表面410之上的部分以及设置在皮肤之下的部分。在这样的实施例中，外部可包括触点(通过迹线(trace)连接到第二部分的对应电极)，从而连接到也设置在用户外部的其他设备，如发射器单元。虽然图4实施例示出了并排设置在底座404的同一表面上的三个电极，其他配置也可考虑，如更少或更多的电极，部分或所有电极在底座的不同表面上或在另一底座上，部分或所有电极叠在一起，不同材料和尺寸的电极等等。
图5A示出了电化学分析物传感器500实施例的透视图，其具有可设置在皮肤表面510之上的第一部分(在该实施例中该第一部分可作为主要部分)、以及包括插入尖部530的第二部分(在该实施例中，该第二部分可作为次要部分)，该第二部分可设置在皮肤下面，如刺穿皮肤并进入例如皮下空间520，与用户的生物流体(如组织间液)接触。工作电极501、参考电极502、及对立电极503的接触部分设置在传感器500的位于皮肤表面510之上的部分上。工作电极501、参考电极502、及对立电极503示出位于第二部分处，尤其位于插入尖部530处。如图5A所示，可以从尖部的电极到触点提供迹线。可以理解可在传感器上设置更多或更少的电极。例如，传感器可包括一个以上的工作电极，和/或对立电极和参考电极可以是单个对立/参考电极等。
图5B示出了图5A中传感器500的一部分的截面视图。传感器500的电极501、502和503以及衬底和介电层设置在层状配置或构造中。例如，如图5B所示，一个方面，传感器500(如图1的传感器单元101)包括衬底层504和设置在衬底层504的至少一部分上的第一导电层501，如碳、金等，并且其可提供工作电极。还示出了设置在第一导电层501的至少一部分上的感测层508。
第一绝缘层，如第一介电层505设置在或层叠在第一导电层501的至少一部分上，且进一步，第二导电层509可设置在或堆叠在第一绝缘层(或介电层)505的至少一部分的顶部上。如图5B所示，第二导电层509可提供参考电极502，且一个方面，可包括银/氯化银(Ag/AgCl)层、金层，等。
在一个实施例中，第二绝缘层506(如介电层)可设置在或层叠在第二导电层509的至少一部分上。进一步，第三导电层503可提供对立电极503。其可设置在第二绝缘层506的至少一部分上。最后，第三绝缘层可设置在或层叠在第三导电层503的至少一部分上。以这种方式，可层叠传感器500，使得每个导电层的至少一部分由对应的绝缘层(例如介电层)分开。图5A和5B的实施例示出了具有不同长度的各层。部分层或所有层可具有相同的或不同的长度和/或宽度。
在某些实施例中，部分或所有电极501、502、503可以上述层状构造设置在衬底504的同一侧，或者可替换地，可以共面方式设置，使得两个或更多电极可设置在衬底504的同一面(如并排(如平行)或相对彼此成角度)上。例如，共面电极可在其间包括合适的间隔和/或包括设置在导电层/电极之间的介电材料或绝缘材料。而且，在某些实施例中，一个或多个电极501、502、503可设置在衬底504的相对侧上。在某些实施例中，接触盘可在衬底的同一侧或不同侧。例如，电极可在第一侧上且其对应的触点可在第二侧上，如连接电极和触点的迹线可横穿衬底。
如上面所述，分析物传感器可包括分析物响应酶以提供感测组件或感测层。某些分析物，如氧，可直接在传感器上电氧化或电还原，且更特别地，至少在传感器的工作电极上电氧化或电还原。其他分析物，如葡萄糖和乳酸，要求有至少一种电子转移剂和/或至少一种催化剂，从而促进分析物的电氧化或电还原。催化剂也可用于那些可直接在工作电极上电氧化或电还原的诸如氧的分析物。对于这些分析物，每个工作电极包括靠近工作电极表面或在其上的感测层(例如参看图5B中的感测层408)。在许多实施例中，感测层形成在至少一工作电极附近或仅在至少一工作电极的小部分上。
感测层包括一个或更多被设计成促进分析物的电化学氧化或还原的组件。感测层可包括例如用于催化分析物反应并在工作电极处产生响应的催化剂、在分析物和工作电极(或其他组件)之间或这两者上转移电子的电子转移剂。
可使用多种不同的感测层配置。在某些实施例中，感测层设置在工作电极的导电材料上。感测层可延伸超出工作电极的导电材料。在某些情形中，感测层也可在其他电极上延伸，如在对立电极和/或参考电极(或提供对立/参考电极)上延伸。
直接与工作电极接触的感测层可含有直接或间接在分析物和工作电极之间转移电子的电子转移剂、和/或促进分析物反应的催化剂。例如，可形成具有感测层的葡萄糖、乳酸、或氧电极，该感测层含有催化剂，如葡萄糖氧化酶、乳酸氧化酶、或漆酶，并含有相应地促进葡萄糖、乳酸、或氧的电氧化的电子转移剂。
在其他实施例中，感测层不是直接沉积在工作电极上。而是感测层64可与工作电极隔开，并且例如通过分隔层与工作电极分离。分隔层可包括一个或多个隔膜或薄膜或物理距离。除了将工作电极与感测层分开，分隔层也可作为传质限制层和/或消除干扰层和/或生物兼容层。
在某些实施例中，包括一个以上的工作电极，一个或更多的工作电极可不具有相应的感测层，或可具有不含电解分析物所需的一个或更多组件(如电子转移剂和/或催化剂)的感测层。因此，工作电极处的信号可相应于背景信号，该背景信号可从与全功能感测层关联的一个或更多其他工作电极获得的分析物信号中除去，例如通过减除该信号。
在某些实施例中，感测层包括一种或更多电子转移剂。可采用的电子转移剂是具有氧化还原电势的可电还原和可电氧化离子或分子，该氧化还原电势是标准甘汞电极(SCE)的氧化还原电势的上下几百毫伏。电子转移剂可以是有机的、有机金属的、或无机的。有机氧化还原物质的例子是醌型化合物和在氧化状态具有醌式结构的物质，如尼罗蓝和靛酚。有机金属氧化还原物质的例子是金属茂络合物，如二茂铁。无机氧化还原物质的离子是铁氰化物(III)、六胺合钌等。
在某些实施例中，电子转移剂具有在样品被分析的时间段内防止或显著减少电子转移剂扩散损耗的结构或电荷。例如，电子转移剂包括但不限于氧化还原物质，如键合到可进而设置在工作电极上或附近的聚合物上。氧化还原物质和聚合物之间的键可以是共价键、配位键、或离子键。虽然任何有机、有机金属或无机氧化还原物质可键合到聚合物并用作电子转移剂，在某些实施例中，氧化还原物质是过渡金属化合物或络合物，如锇、钌、铁、和钴化合物或络合物。可以认识到所描述的与聚合物组分一起使用的许多氧化还原物质也可在无氧化还原物质的情形下使用。
一种类型的聚合物电子转移剂包含在聚合物中共价键合的氧化还原物质。该类媒介的例子是聚(乙烯基二茂铁)。另一类电子转移剂包含离子键合的氧化还原物质。该类媒介可包括耦接到带相反电荷的氧化还原物质的带电聚合物。该类媒介的例子包括耦接到带正电荷的氧化还原物质的带负电荷的聚合物，如锇或钌聚合吡啶。离子键合媒介的另一个例子是带正电荷的聚合物，如耦接到带负电荷的氧化还原物质(如铁氰化物或亚铁氰化物)的季铵化聚(4-乙烯基吡啶)或聚(1-乙烯基咪唑)。在其他实施例中，电子转移剂包括配位键合到聚合物的氧化还原物质。例如，媒介可通过锇或钴2，2’-双吡啶络合物配位到聚(1-乙烯基咪唑)或聚(4-乙烯基吡啶)而形成。
合适的电子转移剂是带有一个或更多配位体的锇过渡金属络合物，每个配位体都具有含氮杂环，如2，2’-双吡啶、1，10-菲咯啉、1-甲基、2-吡啶双咪唑、或其衍生物。电子转移剂还可具有一个或更多共价键合在聚合物中的配位体，每个配位体具有至少一个含氮杂环，如吡啶、咪唑、或其衍生物。电子转移剂的一个例子包括(a)具行吡啶或咪唑官能团的聚合物或共聚物，以及(b)与两个配位体络合的锇阳离子，每个配位体含2，2’-双吡啶、1，10-菲咯啉、或其衍生物，这两个配位体不必相同。某些与锇阳离子络合的2，2’-双吡啶的衍生物包括但不限于4，4’-二甲基-2，2’-双吡啶和单-、双-、和聚烷氧基-2，2’-双吡啶，如4，4’-二甲氧基-2，2’-双吡啶。与锇阳离子络合的1，10-菲咯啉的衍生物包括但不限于4，7-二甲基-1，10-菲咯啉，和单-、双-、和聚烷氧基-1，10-菲咯啉，如4，7-二甲氧基-1，10-菲咯啉。与锇阳离子络合的聚合物包括但不限于聚(1-乙烯基咪唑)(称为“PVI”)和聚(4-乙烯基吡啶)(称为“PVP”)的聚合物和共聚物。聚(1-乙烯基咪唑)的合适共聚物取代基包括丙烯腈、丙烯酰胺、及取代的或季铵化的N-乙烯基咪唑，如具有络合到聚(1-乙烯基咪唑)的聚合物或共聚物的锇的电子转移剂。
实施例可采用具有范围在标准甘汞电极(SCE)上下约-200mV到约+200mV的氧化还原电势的电子转移剂。感测层也可包括能够催化分析物反应的催化剂。在某些实施例中，催化剂也可用作电子转移剂。合适催化剂的一个例子是催化分析物反应的酶。例如，当感兴趣的分析物是葡萄糖时，可使用催化剂，如葡萄糖氧化酶、葡萄糖脱氢酶(如吡咯喹啉醌(PQQ)，依赖性葡萄糖脱氢酶、黄素腺嘌呤二核苷酸(FAD)依赖性葡萄糖脱氢酶、或烟酰胺腺嘌呤二核苷酸(NAD)依赖性葡萄糖脱氢酶)。当感兴趣的分析物是乳酸时，可使用乳酸氧化酶或乳酸脱氢酶。当感兴趣的分析物是氧或当响应分析物反应而产生或消耗氧时，可使用漆酶。
感测层也可包括能够催化分析物反应的催化剂。在某些实施例中，催化剂也可用作电子转移剂。合适催化剂的一个例子是催化分析物反应的酶。例如，当感兴趣的分析物是葡萄糖时，可使用催化剂，如葡萄糖氧化酶、葡萄糖脱氢酶(如吡咯喹啉醌(PQQ)，依赖性葡萄糖脱氢酶或低聚糖脱氢酶、黄素腺嘌呤二核苷酸(FAD)依赖性萄萄糖脱氢酶、或烟酰胺腺嘌呤二核苷酸(NAD)依赖性葡萄糖脱氢酶)。当感兴趣的分析物是乳酸时，可使用乳酸氧化酶或乳酸脱氢酶。当感兴趣的分析物是氧或当响应分析物反应而产生或消耗氧时，可使用漆酶。
在某些实施例中，催化剂可以附着到聚合物上，将催化剂与另一种电子转移剂(如上所述可以是聚合物)交联。在某些实施例中也可使用第二催化剂。该第二催化剂可用于催化由分析物的催化反应得到的产物的反应。第二催化剂可与电子转移剂一起用来电解产物从而在工作电极处产生信号。可替换地，第二催化剂可设置在消除干扰层中从而催化消除干扰的反应。
某些实施例包括Wired EnzymeTM感测层(Abbott Diabetes Care公司)，该感测层工作在弱氧化电势下，如约+40mV的电势。该感测层使用为低电势工作而设计并稳定地附着在聚合物层中的锇(Os)基媒介。因此，在某些实施例中，感测元素是氧化还原活性组分，其包括(1)通过固定到聚合物主链的稳定的(双齿)配位体附着的锇基媒介分子，和(2)葡萄糖氧化酶分子。这两种成分交联到一起。
传质限制层(未示出)，如分析物流量调节层，可包括在传感器中，从而用作减小分析物(例如葡萄糖或乳酸)到工作电极周围区域的传质速率的扩散限制阻挡物。传质限制层对限制分析物到电化学传感器中的工作电极的流量是有用的，因此传感器在大范围的分析物浓度上是线性响应的并易于校准。传质限制层可包括聚合物并可以是生物兼容的。传质限制层可提供许多功能，如生物兼容性和/或消除干扰等等。
在某些实施例中，传质限制层是由含氮杂环基团的交联聚合物构成的隔膜，如聚乙烯吡啶和聚乙烯咪唑的聚合物。实施例还包括由聚氨酯、或聚醚型聚氨酯、或相关化学材料形成的隔膜，或由硅树脂形成的隔膜等。
隔膜可通过聚合物原位交联形成，并以两性离子半族、非吡啶共聚物成分、以及可选的亲水的或疏水的、和/或具有其他期望特性的另一半族在乙醇缓冲溶液中改性。改性的聚合物可由含氮杂环基团的前驱聚合物形成。例如，前驱聚合物可以是聚乙烯吡啶或聚乙烯咪唑。可选地，亲水或疏水改性剂可以用来“微调”最终隔膜对感兴趣分析物的透过性。可选的亲水改性剂(如聚(乙二醇)、羟基或聚羟基改性剂)可用来增强聚合物或最终隔膜的生物兼容性。
隔膜可通过应用交联剂和改性的聚合物的乙醇缓冲溶液到含酶感测层上并允许溶液固化约一到两天或其他合适时间段而原位形成。通过在传感器上滴加这种溶液的液滴，或将传感器浸到溶液中，可将交联剂聚合物溶液应用到感测层上。通常，隔膜的厚度是由溶液浓度、滴加的溶液液滴的数目、传感器浸入溶液中的次数、或这些因素的任何组合控制的。以该方式应用的隔膜可具有下面功能的任何组合：(1)传质限制，即减少能够到达感测层的分析物的流量，(2)生物兼容性增强，或(3)减少干扰。
仅为了方便而非限制本公开的范围，这里的描述主要针对电化学传感器。也可考虑其他的传感器和传感器系统。例如，包括但不限于光学传感器、色度传感器、电势传感器、电量传感器和检测过氧化氢从而推断葡萄糖水平的传感器。例如，可构造过氧化氢检测传感器，其中感测层包括酶，如葡萄糖氧化物、葡萄糖脱氢酶等等，并靠近工作电极设置。感测层可覆盖以选择性透过葡萄糖的隔膜。一旦葡萄糖通过隔膜，其被酶氧化，并且还原的葡萄糖氧化酶可通过与分子氧反应被氧化从而产生过氧化氢。
某些实施例包括由通过交联两种成分而制备的感测层构造的过氧化氢检测传感器，两种成分例如：(1)氧化还原化合物，如含附属(pendent)Os聚吡啶络合物且氧化电势在SCE上约+200mV的氧化还原聚合物，和(2)高碘酸盐氧化的辣根过氧化物酶(horseradish peroxidase，HRP)。这样的传感器工作在还原模式；工作电极被控制在小于Os络合物电势的电势，导致通过HRP催化剂调节过氧化氢的还原。
在另一个例子中，电势传感器可如下构造。葡萄糖感测层通过交联下列物质构造：(1)含附属Os聚吡啶络合物且氧化电势在SCE的约-200mV到+200mV之间的氧化还原聚合物，和(2)葡萄糖氧化酶。通过在零电流流过的条件下将传感器暴露于含葡萄糖的溶液中，并使得还原/氧化Os的比率达到平衡值，该传感器可用于电势模式。还原/氧化Os的比率以可重复的方式随葡萄糖浓度而变化，并引起电极的电势以类似方式改变。
传感器还可包括设置在传感器的至少一部分上的活性剂，如抗凝结和/或抗糖解剂，该传感器位于用户体内。抗凝结剂可减轻或消除传感器周围的血液或其他体液的凝结，特别是在传感器插入后。有用的抗凝结剂的例子包括肝磷脂和组织血纤维蛋白溶酶原活化剂(plasminogen activator，TPA)、以及其他已知的抗凝结剂。实施例可包括抗糖解剂或其前驱体。抗糖解剂的例子是甘油醛、氟化物离子、和甘露糖。
传感器可配置成不需要系统校准或不需要用户校准。例如，传感器可以是工厂校准的而不需要进一步的校准。在某些实施例中，可需要校准，但不用用户干预，即可以是自动的。在需要用户校准的那些实施例中，校准可按照预定程序进行或动态地进行，即校准时间可由系统根据各种因素确定，这些因素诸如但不限于葡萄糖浓度和/或温度和/或葡萄糖改变速率等等。
校准可用体外测试条(或其他参考)实现，如小样品测试条，如需要约小于1微升样品的测试条(例如Abbott Diabetes Care的
Figure G2008800212991D00221
血糖监控测试条)。例如，可使用需要小于约1纳升样品的测试条。在某些实施例中，传感器每次校准时可仅用一种体液样品校准。例如，用户仅需要为校准事件(如为测试条)刺穿身体部位一次以获得样品，或者如果首次获得的样品体积不够，则可在短时间段内刺穿一次以上。实施例包括为给定校准事件获得和使用多种体液样品，这里每种样品的葡萄糖值基本类似。从给定校准事件获得的数据可独立用于校准或与从前面校准事件获得的数据结合用于校准，如包括加权平均值的平均值等。在某些实施例中，系统仅需要由用户校准一次，其中不需要系统的再校准。
分析物系统可包括可选的警报系统，该警报系统例如基于来自处理器的信息警告病人潜在有害的分析物条件。例如，如果葡萄糖是分析物，警报系统可警告用户有关状况，如血糖过低和/或多糖症和/或迫近的血糖过低和/或迫近的多糖症。当分析物水平接近、达到或超过阈值时，可触发警报系统。或者可替换地，当分析物水平增加或减小的变化速率、或变化速率的加速度接近、达到或超过阈值速率或加速度时，警报系统也可被激活。系统还可包括系统警报，其通知用户有关系统信息，如电池状况、校准、传感器移位、传感器故障等等。警报可以是例如听觉的和/或视觉的。还可使用其他感官刺激的警报系统，包括在激活时加热、冷却、振动、或产生适度的电击的警报系统。
本公开还包括用在基于传感器的输药系统中的传感器。该系统可提供药物以响应来自一个或更多传感器的信号而抵消(counteract)分析物的高或低水平。可替换地，该系统可监控药物浓度以确保药物保持在所需的治疗范围内。输药系统可包括一个或更多(如两个或更多)传感器、如发射器的处理单元、接收器/显示单元、以及给药系统。在某些情形中，某些或全部组件可集成到单个单元中。基于传感器的输药系统可使用来自一个或更多传感器的数据，从而为控制算法/机构提供必要的输入以自动或半自动地调整给药。作为例子，可使用葡萄糖传感器来控制和调整来自外部或植入的胰岛素注射器的胰岛素给药。
如上面所述，本公开的实施例涉及检测至少一种分析物(如体液内葡萄糖)的方法和设备。实施例涉及使用连续分析物监控系统连续和/或自动体内监控一种或更多分析物的水平，该分析物监控系统包括分析物传感器，该分析物传感器的至少一部分在一定时间段内设置在用户皮肤表面下面，和/或结合分析物测试条使用体外血糖(“BG”)测试仪离散地监控一种或更多分析物。实施例包括组合的或可组合的设备、系统和方法和/或在体内连续系统间传递数据、以及BG测试仪系统，并包括集成的系统。
实施例包括“数据登录器(Data Logger)”系统，其包括连续葡萄糖监控系统(至少有分析物传感器和控制单元(如身体上单元))。连续葡萄糖监控(“CG”)系统可与BG测试仪具有受限的实时连接。例如，实时连接可限制在传输校准数据(如BG值)到CG系统，或可具有按需从CG系统接收数据的能力(与连续广播这类数据的CG系统相比)。在一个实施例中，数据处理单元102可以是身体上单元，其配置成以几个传输模式操作。在第一模式中，分析物相关的数据可在新数据值(如传感器数据)可用时(例如，当从分析物传感器接收时)传输。该操作模式可能导致“丢失数据”，因为数据处理单元102得不到数据被接收器单元104成功接收的确认，且在某些实施例中，该数据不能再发送。
在第二传输模式中，数据可在新数据可用且数据处理单元102可接收这类数据已经被成功接收的确认时传输，或者如果传输不成功，数据将被存储(“缓存”)以便再次尝试传输。该模式减少了“丢失数据”的可能性。在第三模式(“数据登录模式”)中，数据处理单元102可配置成保持或存储所有数据(即，在数据可用时不尝试传输数据)直到接收器单元104请求数据，或者根据计划的数据传输来传输数据。
通过CG数据登录器获得的CG数据可由数据登录器系统或由BG测试仪和/或由数据管理系统(“DMS”)处理，该数据管理系统可包括如PC的计算机和可选的服务器。例如，可采用AbbottDiabetes Care公司的CoPilotTM数据管理系统等。在某些实施例中，CG系统和BG测试仪都不能支持连续实时CG数据通信(或有这样的能力，但该能力被选择性地关闭)，因而显著降低了功率要求。这类实施例是CG数据登录器，其中CG数据驻存在(即，被登录)CG控制单元(如身体上单元)中，直到其被BG测试仪检索。换句话说，CG数据登录器缓存CG数据并将其存储在存储器中，直到CG数据被下载或传送到BG测试仪，如用户发起数据传送或传送可发生在设定的时间。CG组件登录连续葡萄糖数据，但仅应请求将该数据交给BG测试仪。检索可通过任何合适的方法，包括但不限于无线通信协议(如RF)、光学装置(如IR线路)、蓝牙、或直接连接(如USB等等)等。给定的BG测试仪和CG数据登录器可同步，如通过一个或多个唯一身份，因而确保防止设备间意外的数据交换。
图6示出了系统的示例性实施例，其包括CG数据登录器和增强的BG测试仪。如图所示，增强的BG测试仪可通过有线连接和/或通过IR或RF与CG数据登录器通信。参考附图，一个方面，CG数据登录器可配置成收集并存储在预定的时间段上监控的分析物数据(例如，来自经皮、皮下或植入的分析物传感器)，并实时连续地或周期性地(例如，当CG数据登录器与BG测试仪信号进行通信时(或者有线或者无线))，或者在单个数据传送模式中，例如在预定时间段结束时，传输所收集和存储的分析物数据到BG测试仪。
本发明还提供了“模块化”实施例。在某些实施例中，模块化系统可结合数据登录器系统使用。例如，可分离的CG数据传送模块可配置成与CG数据登录器无线通信，并可进一步配置成可拆卸地与BG测试仪匹配从而传送CG信息到BG测试仪(参考例子图7)。模块化实施例包括提供CG数据给BG测试仪的所有必要的硬件(和软件)，从而在快速搭扣(snap-on)或其他可匹配(mateable)模块中支持连续(实时)或“批量”(数据登录的)CG数据集合。警报功能可包括在BG测试仪中，同样支持CG数据处理和向用户通信的特征，如处理CG数据和/或校准CG数据的硬件和软件，向用户通信CG信息(除了BG信息)的增强用户接口也包括在BG测试仪中，如CG信息可包括CG校准信息、CG趋势信息、指示葡萄糖变化速率的变化速率指示器等等。
模块可被多个用户再使用。可包括用户隐私特征，如模块不能永久存储病人数据(用户数据可在一定时间段后自动删除或清除)，数据可加密、口令保护、或另外提供有一个或更多安全特征，这些将访问仅限于目标用户范围。一个方面，CG数据登录器可配置成收集和存储从分析物传感器接收到的受监控的分析物数据，并在经数据传送模块建立与BG测试仪的数据通信时，随着从传感器接收分析物传感器数据，将所接收的分析物数据在一次或更多批量传送中通信，或连续实时通信。
图7示出模块化系统的示例性实施例，其包括CG控制单元/发射器、可匹配模块和增强的BG测试仪。在该实施例中，所示CG数据登录器/发射器经RF与模块通信，这里模块可匹配地耦接到BG测试仪。然而，也可使用其他合适的数据通信方法，包括IR、蓝牙、Zigbee通信等等。
图8示出集成的或连续的系统，其包括增强的BG测试仪和CG数据登录器/发射器，这里CG数据登录器能够直接并实时地传送CG数据到增强的BG测试仪，在该所示实施例中经无线协议传送。例如，如图所示，增强的BG测试仪可包括允许与CG数据登录器无线通信的RF通信模块或芯片组。因此，随着连续分析物传感器数据被CG数据登录器接收，数据经RF通信线路基本同期传送或实时通信到增强的BG测试仪。
图9示出一系统的示例性实施例，其包括BG测试仪和对接单元，这里所示的被配置为皮带套。BG测试仪经对应于BG测试仪触点的皮带套触点耦接到皮带套。当电耦接到皮带套时，即当对接上或当与皮带套无线信号通信时(如，当从皮带套移出时)，BG测试仪向用户显示信息。皮带套可包括主接收器单元的某些或全部功能，如下面关于CG监控的描述。例如，皮带套可含有某些或全部FreeStyle
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系统，如上面所述的接收器功能。一个方面，皮带套可集成CG数据登录器，使得当对接在皮带套中时(或当与皮带套无线同步时)所收集和存储的分析物数据可传送到BG测试仪。
CG系统可利用BG测试仪校准，如当BG测试仪被对接时。这类系统可在大量情形中有用，如用于妊娠期糖尿病、评估/诊断糖尿病等等。
在某些实施例中，CG系统(无论是模块化的还是包括数据登录器)可配置成具有减少的功能集。例如，其可不包括警报(听得见的和/或振动的和/或看得到的)和/或葡萄糖变化速率指示器和/或视觉或用户接口显示器(如点阵式显示器)和/或额外处理能力和/或微型化，或者可不包括测试条端口。例如，图10示出可包括在示例性全特征CG系统中的特征、及示例性集成的实时系统和示例性数据登录器系统。
在某些实施例中，提供BG系统和CG系统间的同步化以利用BG测试条度量作为参考数据点来校准CG传感器。
在某些实施例中，通过临时性或周期性允许用户的BG测试仪捕获CG数据而无需用户获得其他测试仪，需要更强劲的(即，连续的)葡萄糖监控的用户可使用增强的BG测试仪。类似地，健康护理提供者(“HCP”)的附加值是通过病人周期性地获得更详细的血糖信息(如在规律地检查之前)而获得的，因此允许HCP为病人提供更多信息和合适的治疗调整。
不同实施例具有广泛的应用性。例如，可包括CG传感器之外的内在或外部传感器。来自CG传感器之外的内在或外部传感器的数据可通过这里所述的系统捕获(如温度数据、酮类数据等等)。而且，诸如重量管理、增强的数据管理或胰岛素注射器控制的功能也可通过模块化方法附加到BG测试仪，从而进一步增强测试仪。在某些实施例中，数据登录器包括提供模制的电触点，其允许通过身体上的外壳电连接，而不会削弱外壳的水密封性。
这里的实施例通过向基础的BG测试仪添加CG功能而向病人提供BG测试仪的增加值、低学习曲线从而用户不必熟悉两种不同的用户接口(一种用于BG单元而另一种用于CG系统)、整个系统成本减少、及对环境的显著安全性，其中例如在飞机飞行过程中、在医院内或其他具有可干扰RF或其他无线信号的灵敏仪器的场所可阻止连续无线通信。
因此，在一个实施例中，分析物监控系统包括：经皮设置在对象皮层下面的分析物传感器；可操作地耦接到分析物传感器的数据处理设备，该设备包括控制单元、可操作地耦接到控制单元并配置成存储与传感器接收的被监控分析物水平关联的多个数据的存储器、及可操作地耦接到控制单元的通信单元；以及配置成与数据处理设备信号通信的血糖测试仪，这里当数据处理设备的控制单元检测到与血糖测试仪的通信线路时，控制单元进一步配置成从存储器检索所存储的多个数据并将检索的数据传输到血糖测试仪。
血糖测试仪包括接收血糖测试条的测试条端口。
通信单元可配置成利用有线连接、USB缆线连接、串行缆线连接、RF通信协议、红外通信协议、蓝牙通信协议、或802.11x通信协议中的一种或多种与血糖测试仪通信。
在一个实施例中，数据处理设备不包括用户输出组件，这里用户输出组件包括显示器。
控制单元可根据对测试仪的有线连接检测来检测与血糖测试仪的通信线路。
检索到的所存储的多个数据可相应于在预定时间段上收集的对象的葡萄糖数据。
葡萄糖数据可以是未校准的或校准的。
分析物传感器可以是葡萄糖传感器。
一个方面，血糖测试仪可包括配置成输出一个或更多个所接收的检索数据的输出单元。
输出单元可包括可操作地耦接到血糖测试仪壳体的显示单元。
一个或更多接收数据的输出可包括图形输出、数值输出或文本输出。
血糖测试仪可配置成校准所接收的数据。
血糖测试仪可包括配置成存储已校准数据的存储单元。
血糖测试仪可包括配置成存储所接收数据的存储单元。
另一方面，系统可包括容纳血糖测试仪的皮带套设备，且数据处理单元可集成到该皮带套设备中。
控制单元可配置成在测试仪耦接到皮带套时检测与血糖测试仪的通信线路。
皮带套设备可包括皮带夹。
在另一个实施例中的方法可包括：将分析物传感器经皮设置在对象的皮层下面、将数据处理设备耦接到分析物传感器、在数据处理设备的存储器中存储与传感器接收的被监控分析物水平关联的多个数据、将通信单元可操作地耦接到控制单元、检测与血糖测试仪的通信线路、从存储器检索所存储的多个数据、以及命令通信单元将检索到的数据传输到血糖测试仪。
通信线路可基于有线连接、USB缆线连接、串行缆线连接、RF通信协议、红外通信协议、蓝牙通信协议、或802.11x通信协议中的一种或多种而建立。
该方法可包括在血糖测试仪上显示所接收的分析物数据。
检索到的数据可相应于在预定时间段上收集的对象的葡萄糖数据。
该方法可包括校准所接收的数据。
另一个方面，该方法包括在血糖测试仪的存储器中存储所接收的数据。
在进一步的方面，该方法可包括在将数据传输到血糖测试仪之前加密所检索的数据。
在不偏离本公开范围和精神的前提下，本公开的结构和操作方法中的各种其他修改和替换对本领域技术人员来说是显然的。虽然已经结合具体实施例描述了本公开，但应该理解所要求保护的本公开不限于这些具体实施例。本发明权利要求限定本公开的范围，其涵盖该范围及其等同物范围内的结构和方法。

Claims (30)

1.一种分析物监控系统，包括：
分析物传感器，用于经皮设置在对象的皮层下面；
数据处理设备，可操作地耦接到所述分析物传感器，所述设备包括：
控制单元；
存储器，可操作地耦接到所述控制单元并配置成存储与从所述传感器接收的被监控分析物水平关联的多个数据；以及
通信单元，可操作地耦接到所述控制单元；以及
血糖测试仪，配置成与所述数据处理设备进行信号通信；
其中，当所述数据处理设备的控制单元检测到与所述血糖测试仪的通信线路时，所述控制单元进一步配置成从所述存储器检索所存储的多个数据并将所检索的数据传输到所述血糖测试仪。
2.根据权利要求1所述的系统，其中，所述血糖测试仪包括接收血糖测试条的测试条端口。
3.根据权利要求1所述的系统，其中，所述通信单元配置成利用有线连接、USB缆线连接、串行缆线连接、RF通信协议、红外通信协议、蓝牙通信协议、或802.11x通信协议中的一种或多种与所述血糖测试仪通信。
4.根据权利要求1所述的系统，其中，所述数据处理设备不包括用户输出组件。
5.根据权利要求4所述的系统，其中，所述用户输出组件包括显示器。
6.根据权利要求1所述的系统，其中，所述控制单元根据对所述测试仪的有线连接的检测而检测与所述血糖测试仪的通信线路。
7.根据权利要求1所述的系统，其中，检索到的所存储的多个数据相应于在预定时间段上收集的对象的葡萄糖数据。
8.根据权利要求7所述的系统，其中，所述葡萄糖数据是未校准的。
9.根据权利要求7所述的系统，其中，所述葡萄糖数据是校准的。
10.根据权利要求1所述的系统，其中，所述分析物传感器是葡萄糖传感器。
11.根据权利要求1所述的系统，其中，所述血糖测试仪包括配置成输出一个或多个所接收的检索数据的输出单元。
12.根据权利要求11所述的系统，其中，所述输出单元包括可操作地耦接到所述血糖测试仪的壳体的显示单元。
13.根据权利要求11所述的系统，其中，一个或多个接收的数据输出包括：
图形输出、数值输出、或文本输出。
14.根据权利要求1所述的系统，其中，所述血糖测试仪配置成校准所接收的数据。
15.根据权利要求14所述的系统，其中，所述血糖测试仪包括配置成存储已校准数据的存储单元。
16.根据权利要求1所述的系统，其中，所述血糖测试仪包括配置成存储所接收数据的存储单元。
17.根据权利要求1所述的系统，包括容纳所述血糖测试仪的皮带套设备。
18.根据权利要求17所述的系统，其中，所述数据处理单元被集成到所述皮带套设备中。
19.根据权利要求17所述的系统，其中，所述控制单元经配置成在所述测试仪耦接到皮带套时检测与所述血糖测试仪的通信线路。
20.根据权利要求17所述的系统，其中，所述皮带套设备包括皮带夹。
21.一种方法，包括：
将分析物传感器经皮设置在对象的皮层下面；
将数据处理设备耦接到所述分析物传感器；
在所述数据处理设备的存储器中存储与从所述传感器接收的被监控分析物水平关联的多个数据；
将通信单元可操作地耦接到所述控制单元；
检测与所述血糖测试仪的通信线路；
从所述存储器检索所存储的多个数据；以及
命令所述通信单元将所检索的数据传输到所述血糖测试仪。
22.根据权利要求21所述的方法，其中，所述通信线路是基于有线连接、USB缆线连接、串行缆线连接、RF通信协议、红外通信协议、蓝牙通信协议、或802.11x通信协议中的一种或多种而建立的。
23.根据权利要求21所述的方法，包括在所述血糖测试仪上显示所接收的分析物数据。
24.根据权利要求21所述的方法，其中，所检索的数据相应于在预定时间段上收集的对象的葡萄糖数据。
25.根据权利要求24所述的方法，其中，所述葡萄糖数据是未校准的。
26.根据权利要求24所述的方法，其中，所述葡萄糖数据是校准的。
27.根据权利要求21所述的方法，其中，所述分析物传感器是葡萄糖传感器。
28.根据权利要求21所述的方法，包括校准所接收的数据。
29.根据权利要求21所述的方法，包括在所述血糖测试仪的存储器中存储所接收的数据。
30.根据权利要求21所述的方法，包括在将数据传输到所述血糖测试仪之前加密所接收的数据。
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