CN101180093B - 用于提供结合的药剂输液以及分析物监测系统的方法和系统 - Google Patents

用于提供结合的药剂输液以及分析物监测系统的方法和系统 Download PDF

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CN101180093B
CN101180093B CN2006800176500A CN200680017650A CN101180093B CN 101180093 B CN101180093 B CN 101180093B CN 2006800176500 A CN2006800176500 A CN 2006800176500A CN 200680017650 A CN200680017650 A CN 200680017650A CN 101180093 B CN101180093 B CN 101180093B
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本杰明·M·拉什
克里斯托弗·V·雷贾尔多
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Abbott Diabetes Care Inc
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Abstract

本发明提供了方法和系统，用于结合输液装置和分析物监测系统，其包括药剂输液装置如胰岛素泵以及分析物监测系统如葡萄糖监测系统。

Description

用于提供结合的药剂输液以及分析物监测系统的方法和系统
技术领域
本发明涉及用于集成(或整合)输液系统与分析物监测系统的方法和系统。更具体地说，本发明涉及用于集成(或整合)胰岛素输液装置与连续分析物监测系统的方法和系统。 
背景技术
必须周期性地给予I型糖尿病患者胰岛素以维持其生理条件。通常，利用针型注射器给予这些患者快速作用或缓慢作用剂量的胰岛素，例如，在进餐前，和/或在每天的适当时间，其是和利用例如手指采血(fingerstick)测试进行血糖水平(血糖含量)测试在同一时间。如果未适当给予胰岛素，则糖尿病患者的身体会遭受严重的(如果不是致命的)损伤的危险。 
近年来对外部输液泵疗法的持续开发和改善已引起糖尿病患者的更大兴趣：即(除了别的以外)通过更好地调节和控制胰岛素的摄取来改善对糖尿病的管理。通常，患者插入插管(其连接于输液管，而输液管又连接于外部泵)，然后基于预编程的基础方式(basal profile)给予胰岛素。此外，目前可获得的外部输液装置包括计算能力以确定适宜的推注剂量(bolus dose)如碳水化合物推注和矫正推注，例如，和执行患者基础方式(profile)的输液装置一起给予。 
基础方式通常由患者的医师或护理人员确定并且基于许多因素(包括由例如患者的医师诊断的患者的胰岛素敏感性以及生理条件)，而且通常用来准确地估计在患者输注胰岛素过程的预定期间的患者葡萄糖水平。可以基于患者的周期性离散的测试来估计葡萄糖水平，其中测试利用测试条以及血糖仪如可获自Abbott DiabetesCare，Inc.，of Alameda，California的Freestyle
Figure 2006800176500_0
Glucose Meter。然而，这样的估计易出错误，并且并不准确地反映患者的实际生理条件。 
发明内容
鉴于上述，因此希望具有这样一种集成系统，其结合有输液装置如胰岛素输液泵以及分析物监测系统如连续葡萄糖监测系统的功能。 
根据以下具体实施方式、所附权利要求以及附图的详细描述，本发明的这些和其它目的、特征以及优点将变得更显而易见。 
附图说明
图1示出了根据本发明一种具体实施方式的集成输液装置和分析物监测系统； 
图2示出了根据本发明另一具体实施方式的集成输液装置和分析物监测系统； 
图3示出了根据本发明又一具体实施方式的集成输液装置和分析物监测系统； 
图4示出了根据本发明又一具体实施方式的集成输液装置和分析物监测系统； 
图5示出了根据本发明又一具体实施方式的集成输液装置和分析物监测系统； 
图6示出了根据本发明又一具体实施方式的集成输液装置和监测系统； 
图7A更详细地示出了图6所示的在本发明一种具体实施方式中的集成输液装置和监测系统，而图7B-7C分别示出了图7A所示的根据本发明一种具体实施方式的集成输液装置和监测系统的位于患者界面的模拟前置电路以及泵机组； 
图8A-8C分别示出了供连续分析物监测系统之用的无源传感器构造，以及在根据本发明一种具体实施方式的集成输液装置和监测系统的患者界面处使用的有源传感器构造的两种具体实施方式； 
图9示出根据本发明一种具体实施方式的集成输液装置和分析物监测系统，其中输液装置和监测系统发送器结合到由患者戴用的单个贴剂中； 
图10是根据本发明一种具体实施方式的结合有分析物监测系统传感器电极的输液装置插管的详细视图； 
图11A示出了根据本发明另一具体实施方式的结合有分析物监测系统传感器电极的输液装置插管的部件透视图，而图11B示出了根据本发明一种具体实施方式的结合有输液装置的分析物监测系统发送器单元的俯视平面图； 
图12A-12C每一示出了分别根据本发明的不同具体实施方式结合有图10的连续分析物监测系统传感器电极的输液装置插管的剖视图；以及 
图13是定时图，用于说明在一种具体实施方式中由集成输液装置和监测系统进行的血糖测量和胰岛素递送的时间间隔。 
具体实施方式
图1示出了根据本发明一种具体实施方式的结合的(集成的，整合的，integrated)输液装置和分析物监测系统。参照图1，根据本发明一种实施方式的集成输液装置和分析物监测系统100包括输液装置110，其连接于用于液体运输或输注的输液管130，并且输液管130进一步连接于插管170。如从图1可以看到的，插管170被构造以可安装地连接于发送器单元150，其中发送器单元150还可安装地连接于分析物传感器160。还提供了一种分析物监测器单元120，其被构造以通过通信路径140与发送器单元无线通信。 
参照图1，在本发明的一种具体实施方式中，发送器单元150被构造成用于经过通信路径140单向无线通信到分析物监测器单元120。在一种具体实施方式中，分析物监测器单元120可以被构造为包括用于通过通信路径140进行双向通信的发送器单元(未示出)。在一种具体实施方式中，发送器单元150可以被构造以周期性地和/或间歇性地将与分析物水平(由分析物传感器160检测)有关的信号传输到分析物监测器单元120。分析物监测器单元120可以被构造为接收来自发送器单元150的信号，而在一种具体实施方式中，分析物监测器单元120被构造为基于一种或多种预编程或预定方法进行数据存储和处理。 
例如，在一种具体实施方式中，分析物监测器单元120被构造成在数据存储单元(未示出)中存储接收的与分析物水平(分析物含量)有关的信号。可替换地，或此外，分析物监测器单元120可以被构造成处理与分析物水平有关的信号，从而产生趋势指示，通过，例如，折线图的可视显示或基于角图标的显示，在显示单元121  上进行输出显示。另外的信息可以输出显示在分析物监测器单元120的显示单元121上，其包括但不限于接收自发送器单元150的患者的基本上同时和实时的分析物水平(如由传感器160所检测的)。可以以数字格式或以任何其它适宜格式显示实时分析物水平，其向患者提供由传感器160所检测的基本上实时分析物水平的准确测量结果。 
传感器160可以监测或确定的另外的分析物包括，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、乳酸盐、过氧化物、前列腺特异性抗原、前凝血素、RNA、促甲状腺激素、以及肌原蛋白。也可以确定药物的浓度，如抗生素(例如，艮他霉素、万古霉素等)、洋地黄毒苷、地高辛、滥用药物、茶碱、以及华法林。 
回到图1，传感器160可以包括短期(例如，3天、5天或7天)分析物传感器，其在预期的使用奉命以后被更换。此外，在一种具体实施方式中，传感器160被构造以定位在患者皮肤的皮下，使得至少部分分析物传感器保持与患者的分析物(如，间隙液或血液)液体接触。此外，被构造成类似地定位在患者皮肤下面的插管170连接于输液装置110的输液管130，以便向患者递送药剂如胰岛素。此外，在一种具体实施方式中，插管170被构造以在更换传感器160时被更换。 
在本发明的一个方面，插管170和传感器160可以被构造以皮下定位在患者的皮肤下面，其中利用插入机构(未示出)如插入枪，其可以包括，例如，弹簧偏置或加载的插入机构以将插管170和传感器160基本上准确地定位在患者的皮肤下面。以这种方式，插管170和传感器160可以皮下定位而患者几乎没有或没有感到疼痛。可替换地，插管170和/或传感器160可以被构造以由患者人工插入通过患者的皮肤。在定位插管170和传感器160以后，通过粘合层180它们可以基本上牢固地保持在适当位置，其中粘合层180被构造成粘附于患者皮肤一段时间，其间传感器160和插管170被皮下定位。
此外，在一种具实施方式中，可以在皮下定位传感器160和插管170以后安装发送器单元150，以便与传感器电极电接触。类似地，输液管130可以被构造成可操作地(工作地，operatively)连接于发送器单元150的护罩，以便准确定位从而对准插管170，以及提供充分的不透水密封。美国专利第6,175,752号(授予本发明的代理人，Abbott Diabetes Care，Inc.)中提供了包括传感器160、发送器单元150以及分析物监测器单元120的分析物监测系统的另外详细的描述。 
回到图1，输液装置110可以有能力编程基础方式以及计算推注剂量，其包括但不限于矫正推注、碳水化合物推注、追加推注(扩大量，extended bolus)、以及双推注(dual bolus)，其可以由患者利用输液装置110来进行，并且可以基于一种或多种因素，这些因素包括患者的胰岛素敏感性、伙食中的胰岛素、预期的碳水化合物摄取量(例如，用于进餐前的碳水化合物推注计算)、患者的测得的或检测到的葡萄糖水平、以及患者的葡萄糖趋势信息。在另一具体实施方式中，推注计算能力还可以设置在分析物监测器单元120中。 
在一种具体实施方式中，分析物监测器单元120被构造成具有基本上紧凑的外罩，其可以由患者容易地携带。此外，输液装置110类似地可以被构造成基本上紧凑的装置，其可以容易和方便地戴在患者的衣服上(例如，安放在手枪套或承载装置中，其由患者戴用或夹于患者的皮带或衣服的其它部分)。再一次参照图1，分析物监测器单元120和/或输液装置110可以包括用户界面如由患者进行的 信息输入机构以及数据输出，其包括，例如，在分析物监测器单元120上的显示单元121、或类似地在输液装置110上的显示单元111。 
一种或多种声音输出装置如扬声器或蜂鸣器可以与输液装置110和/或分析物监测器单元120的外罩结合，以便输出声音警报或报警，其是基于与输液装置110或分析物监测器单元120有关的一种或多种预定状态的发生。例如，输液装置110可以被构造，以便在检测到输液管130的阻塞或发生定时事件(如在更换插管170以后使输液管准备好的提醒物)等以后，向患者输出声音警报或报警。分析物监测器单元120可以类似地被构造以当预定状态或预编程事件发生时输出声音警报或报警，如在使用寿命(3天、5天或7天)以后更换传感器160的提醒物，或与接收自发送器单元150的数据(相应于患者的监测的分析物水平)有关的一种或多种警报。这样的警报或报警可以包括向患者发出的报警：检测的分析物水平超过预定阈值水平，或在给定时间内检测的分析物水平的趋势表现出显著的状态如潜在的高血糖或低血糖，其需要注意或校正作用。值得注意的是，以上描述的声音警报和/或报警的实例仅用于说明的目的，在本发明的范围内，可以将其它事件或状态(condition)编程到输液装置110或分析物监测器单元120或两者中，以便向患者报警或通知上述事件或状态的发生或潜在发生。 
此外，在本发明的范围内，可以单独输出声音报警，或连同一种或多种可视警报如分别在输液装置110或分析物监测器单元120的显示单元111、112上的输出显示，或振动警报，其向患者提供有关报警和/或警报的触觉指示。 
此外，再次参照图1，虽然示出一个分析物监测器单元120和一个发送器单元150，但在本发明的范围内，可以提供另外的分析物监测器单元或发送器单元，使得，例如，发送器单元150可以被构造成基本上同时地传输到多个分析物监测器单元。可替换地，连  接于多个传感器(同时与患者的分析物液体接触)的多个发送器单元可以被构造成传输到分析物监测器单元120、或传输到多个分析物监测器单元。例如，连接于附加传感器的附加发送器单元可以设置在集成输液装置和分析物监测系统100中，其中系统100并不包括插管170，并且可以用来实现与传感器160有关的功能如传感器校准、传感器数据验证等。 
在一种具体实施方式中，发送器单元150被构造以传输从传感器160接收的采样数据信号而没有来自分析物监测器单元120的确认：传输的采样数据信号已接收到。例如，发送器单元150可以被构造以在完成初始开机程序以后以固定速率(例如，以1分钟间隔)传输编码的采样数据信号。同样，分析物监测器单元120可以被构造成以预定时间间隔检测上述传输的编码的采样数据信号。可替换地，发送器单元150和分析物监测器单元120可以被构造以通过通信路径140进行双向通信。 
另外，在一个方面，分析物监测器单元120可以包括两个部分。分析物监测器单元120的第一部分可以包括模拟界面部分，其被构造成借助于通信路径140与发送器单元150进行通信。在一种实施方式中，模拟界面部分可以包括RF接收器和天线，用于接收和放大来自发送器单元150的数据信号，其后通过本地振荡器(localoscillator)对其进行解调并通过带通滤波器对其进行过滤。分析物监测器单元120的第二部分可以包括数据处理部分，其被构造成处理从发送器单元150接收的数据信号，如通过执行数据解码、检错和修正、数据时钟发生、以及数据位恢复。 
在操作中，在完成开机程序以后，分析物监测器单元120被构造成基于例如接收自发送器单元150的检测到的数据信号的强度或预定的发送器识别信息并在其范围内检测发送器单元150的存在。在与发送器单元150成功同步以后，分析物监测器单元120被构造  成开始从发送器单元150接收对应于患者的所检测分析物的数据信号，例如，葡萄糖水平。 
再次参照图1，分析物监测器单元120或输液装置110或两者可以被构造成进一步与数据处理终端(未示出)进行通信，其中数据处理终端可以包括台式计算机终端、可以进行数据通信的信息站、膝上型计算机、手提式计算装置如个人数字助理(PDA)、或可以进行数据通信的移动电话等，其每一种可以被构造以借助于有线或无线连接进行数据通信。数据处理终端例如可以包括例如医院环境中的医师终端和/或床边终端。 
用于图1的发送器单元150和分析物监测器单元120之间的数据通信的通信路径140可以包括在两个或多个电子装置之间的RF通信链路、蓝牙通信链路、红外通信链路、或任何其它类型的适宜的无线通信连接。数据通信链路还可以包括有线电缆连接例如但不限于RS232连接、USB连接、或串行电缆连接。 
再一次参照图1，在本发明的另一方面，分析物监测器单元120或输液装置110(或两者)还可以包括测试条口，该测试条口被构造成容纳用于离散采样患者血液以进行葡萄糖水平确定的血糖测试条。血糖测试条仪单元的功能的一个实例可以参见可获自本发明的代理人，Abbott Diabetes Care，Inc.的Freestyle
Figure 2006800176500_1
Blood GlucoseMeter。 
以上述方式，在本发明的一种具体实施方式中，用于输注胰岛素或其它适宜药剂的插管170和粘附贴剂180结合，其中粘附贴剂180用于分析物监测系统的传感器160和发送器单元150。因此，患者可以戴用仅一个皮肤上贴剂(例如，在腹的皮肤上)而不是两个分开的贴剂，其用于输液装置插管170以及分析物监测系统传感器160(具有发送器单元150)。因此，I型糖尿病患者可以方便地  连同实时葡萄糖监测一起实施输注疗法，同时将在粘附贴剂180部位对患者皮肤的潜在皮肤刺激降低到最小程度，因而提供更多的较少刺激的插入部位。 
此外，如图1所示的集成输液装置和分析物监测系统100可以被构造以使输液管130可以与输液装置110以及与发送器单元150(或粘附贴剂180)的外罩分开，从而，可选地，患者可以使系统构造为连续分析物监测系统同时中止输液装置110的功能。 
此外，根据本发明的一种具体实施方式，通过具有基本上连续的实时葡萄糖数据、基于基本上连续的实时葡萄糖数据的趋势信息，患者可以更好地管理与糖尿病有关的生理状态，因此根据预编程的基础方式(输液装置110被构造成实施所述基础方式)来改善或调节由输液装置110递送的输液水平。 
图2示出了根据本发明的另一具体实施方式的集成输液装置和分析物监测系统。参照图2，根据本发明一种具体实施方式的集成输液装置和分析物监测系统200包括集成输液装置和分析物监测器单元210，其连接于输液管220，而输液管220连接于插管260。图2中还示出发送器单元240，其与分析物传感器250电接触，其中插管260和分析物传感器250皮下定位在患者皮肤的下面，并且通过粘合层或贴剂270保持在适当位置。 
参照图2，集成输液装置和分析物监测器单元210被构造成通过通信路径230(如RF通信链路)与发送器单元240无线通信。与图1所示的具体实施方式相比，可以看出，在图2所示的具体实施方式中，输液装置和分析物监测器被结合到单个外罩210中。以这种方式，发送器单元240被构造成将相应于检测的分析物水平的信号(接收自分析物传感器250)传输到集成输液装置和分析物监测器单元210，用于数据分析和处理。 
因此，患者可以方便地接收来自发送器单元240的实时葡萄糖水平，因此，确定是否改变现有的基础方式，并据此向患者递送胰岛素。以这种方式，分析物监测器单元的功能可以结合在输液装置的紧凑外罩内，以向患者提供另外的方便，例如，通过向输液装置的用户界面提供实时葡萄糖数据以及其它有关信息如葡萄糖趋势数据，使得患者可以容易地确定对胰岛素泵的输注速率的任何适宜的改变。 
在一种具体实施方式中，图2示出的每个部件的构造，包括插管260、分析物传感器250、发送器单元240、粘合层270、通信路径230、以及输液管220和输液装置和分析物监测器的功能，基本上类似于以上连同图1一起描述的相应的各个部件。 
因此，在本发明的一种具体实施方式中，在保持和增强糖尿病管理方面可以向患者提供另外的方便，例如，通过具有单个集成装置如集成输液装置和分析物监测器单元210，其可以使患者利用集成输液装置和分析物监测器单元210的单个用户界面系统来容易地操作和管理胰岛素疗法。确实，通过在一个装置中提供许多与葡萄糖水平有关的信息以及胰岛素输注信息，在管理糖尿病和改善胰岛素疗法方面可以向患者提供另外的方便。 
图3示出了根据本发明的又一具体实施方式的集成输液装置和分析物监测系统。参照图3，在本发明的一种具体实施方式中，集成输液装置和分析物监测系统300包括输液装置310，其连接于输液管340，而输液管340又连接于插管370。插管370被构造成皮下定位在患者皮肤的下面并通过粘合层380基本上保持在适当位置。如上所述以及类似于连同图1-2所描述的具体实施方式，同样保持在适当位置的还有分析物传感器360，其同样皮下定位在患者皮肤下面并保持与患者的分析物液体接触。提供了发送器单元350以便电连接于分析物传感器360电极。同样，如从图3可以看到的，  在一种具体实施方式中，输液管340连接于发送器单元350的外罩以便连接于布置在患者皮肤下面的插管370。 
参照图3，还提供了分析物监测器单元320，其被构造成与发送器单元350无线通信，以从其接收与患者的分析物水平(由分析物传感器360检测)有关的数据。参照图3，在一种具体实施方式中，输液装置310并不包括用户界面如显示单元和/或输入单元如按钮或微动转盘(iog dial)。相反，用户界面和控制机构被设置在分析物监测单元320上，使得分析物监测单元320被构造成无线控制输液装置310的操作，并进一步适当地编程输液装置310以执行预编程基础方式，以及以其它方式控制输液装置310的功能。 
更具体地说，所有用于输液装置310的编程和控制机构都设置在分析物监测单元320中，使得当患者戴用输液装置310时，它可以小心地戴用在衣服下并在患者皮肤输注部位(如腹)的附近，同时患者仍然可以通过分析物监测单元320来方便地控制输液装置310。 
此外，在一种具体实施方式中，图3所示的每个部件的构造，包括插管370、分析物传感器360、发送器单元350、粘合层380、通信路径320、以及输液管340和输液装置和分析物监测单元320的功能，基本上类似于如以上连同图1一起所描述的相应的各个部件。然而，在图3所示的具体实施方式中输液装置310被构造成使收发器或等效通信机构与分析物监测单元320通信。 
以这种方式，在本发明的一种具体实施方式中，输液装置310的构造(没有用户界面)提供了更小和更轻的外罩以及用于输液装置310的构造，其将增强患者戴用和/或携带输液装置310时的舒适感。此外，因为在分析物监测单元320上设置了输液装置310的控制和编程功能，所以患者可以方便地编程和/或控制输液装置310的  功能和操作，而没有限制于连接于插管370(其定位在患者皮肤的下面)的输液管340。此外，因为在分析物监测单元320上远程进行输液装置310的编程和控制，所以输液管340可以更短并因此更方便。 
图4示出了根据本发明的又一具体实施方式的集成输液装置和分析物监测系统。参照图4，在本发明的一种具体实施方式中，集成输液装置和分析物监测系统400包括输液装置410，其被构造成通过通信路径430如RF(射频)链路与分析物监测单元420无线通信。此外，如从图4可以进一步看到的，输液装置410连接于输液管440，其在其中提供有连接于分析物传感器电极的集成导线(integral wires)。如下文更详细讨论的，借助于输液管440，输液装置410接收患者的测得的分析物水平并传输到分析物监测单元420，用于进一步处理和分析。 
更具体地说，参照图4，集成输液装置和分析物监测系统400包括贴剂450，其设置有插管470和分析物传感器460。插管470被构造成将药剂如胰岛素从输液装置410递送或输注到患者。即，在一种具体实施方式中，插管470和分析物传感器460被构造成皮下定位于患者的皮肤。分析物传感器460被构造以定位成与患者的分析物液体接触。 
以这种方式，分析物传感器460电连接于设置在输液管440内的集成导线，以便向输液装置410提供相应于患者的测得的或检测到的分析物水平的信号。在一种具体实施方式中，输液装置410被构造成执行数据分析和存储，以使输液装置410可以被构造成在显示单元411上向患者显示实时测得的葡萄糖水平。此外或可替换地，输液装置410被构造成将从分析物传感器460接收到的信号无线传输到分析物监测单元420用于数据分析、显示、和/或存储，并且分  析物监测单元420可以被构造成远程控制输液装置410的功能和特点，从而提供另外的用户方便和不连续性。 
回到图4，在一种具体实施方式中，贴剂450可以被构造以显著较小而没有发送器单元安装在其上，并且提供相对较小的附着于患者皮肤的表面积。以这种方式，可以向患者提供另外的方便之处：具有基本紧凑的外罩安装在皮肤上(例如，用粘合层进行附着)来输注药剂如胰岛素，以及借助于分析物传感器460来进行连续分析物监测。 
图5示出了根据本发明的又一种具体实施方式的集成输液装置和分析物监测系统。与图4所示的具体实施方式相比，图5的集成输液装置和分析物监测系统500包括集成输液装置和分析物监测单元510。因此，向用户提供了一个用户界面，其包括显示单元511和输入按钮512(设置在集成输液装置和分析物监测单元510的外罩上)。在图5中示出的还有输液管520，其中集成导线设置在其中并连接于与患者的分析物液体接触的分析物传感器540电极。此外，如从图5可以看到的，提供了粘附贴剂530，以将插管550和分析物传感器540的皮下位置保持在患者皮肤下面所希望的位置。 
可选地，集成输液装置和分析物监测单元510可以具备无线或有线通信能力，以便通过无线通信路径如RF通信链路、或通过电缆连接如USB连接与远程终端(如医师的计算机终端)通信。回到图5，在本发明的一种具体实施方式中，向使用输注疗法的糖尿病患者提供较少的要处理或操作的部件可进一步简化胰岛素疗法和葡萄糖水平监测和管理。 
图6示出了根据本发明的又一种具体实施方式的集成输液装置和监测系统。参照图6，集成输液装置和分析物监测系统600设置有输液装置而没有用户界面，并且被构造成通过通信路径630如  RF链路与分析物监测单元620无线通信。输液装置610(其可以设置在紧凑外罩中，因为它并不结合有与用户界面有关的部件)连接于输液管640，在输液管640中放置有集成导线，而这些集成导线相应地连接于与患者的分析物液体接触的分析物传感器660的电极。此外，在一种具体实施方式中，紧凑粘附贴剂650被构造成将插管670和分析物传感器660保持在患者皮肤下面的所希望的位置。 
类似于图3所示的具体实施方式，分析物监测单元620被构造成通过通信链路630来控制和编程输液装置610。以这种方式，通过分析物监测单元620可以远程实现输液装置610的控制和编程功能，从而为患者提供方便。 
图7A更详细地示出了图6所示的在本发明的一种具体实施方式中的集成输液装置和监测系统，而图7B-7C分别示出了图7A所示的根据本发明的一种具体实施方式的集成输液装置和监测系统的位于患者界面的模拟前置电路以及泵机组。参照图7A，其示出了输液装置710，输液装置710连接于输液管720，其中设置有集成导线用于连接到分析物传感器的电极。输液管720进一步连接于粘附贴剂730，其被构造成将插管750和分析物传感器740保持在患者皮肤下面的所希望的皮下位置。 
参照图7A，在本发明的一种具体实施方式中，输液装置710可以设置有第一模拟前置电路单元711，而粘附贴剂可以设置有第二模拟前置电路单元731。来自分析物传感器740的集成导线被构造成经过输液管720从输液装置710延伸到粘合层730。因为在一种具体实施方式中分析物传感器740是无源部件，鉴于电极的高阻抗以及集成导线的长度(超过几厘米)，所以在分析物传感器的工作电极和参考电极上的信号易受噪声的影响。噪声本身可以潜在地  有害影响工作电极和参考电极上的信号，其可以使分析物传感器740检测到的分析物水平失真。 
鉴于集成导线的长度(其对应于输液管720的长度)，在一种具体实施方式中，可以将来自工作电极和参考电极的信号转换成低阻抗信号，以使来自噪声的有害影响降到最低程度。因此，输液装置710可以设置有第一模拟前置电路单元711，而粘附贴剂730可以设置有第二模拟前置电路单元731，如下文连同图7B和图7C进一步详细讨论的。 
现在参照图7B，在一种具体实施方式中，设置在患者皮肤上的粘附贴剂730上的第二模拟前置电路单元731包括跨阻抗放大器(电流-电压转换器或“I-V”)731A，其被构造成将工作电极(W)电流转换成电压(Vw)并提供保险信号(G)，以及伺服段(servosegment)731B以基于参考电极(R)电压驱动反电极(C)电压(Vc)。图7B还示出了低通滤波器(LPF)和增益阶段(增益级，gain stage)711A，其跟随每个I到V以及伺服阶段，并且在一种具体实施方式中其构造成驱动A/D(模拟-数字)转换器单元711C，其结果由控制器如中央处理器(CPU)711D读取。A/D转换器单元711C和CPU 711D以及其它外围设备可以结合到单个集成电路(IC)中，其中单个集成电路也称作微控制器(μC)如MSP430产品系列。 
现在参照图7C，在一种具体实施方式中，可以通过一对运算放大器(731A和731B)、四个电阻器(R1、R2、R3、Rf)、以及旁路电容器(Cb)来实施第二模拟前置电路单元731。利用运算放大器731A的I到F阶段是通过来自工作电极(W)的输入电流的作用所产生的，其中输入电流流过反馈电阻器(Rf)并产生电压差，其是由运算放大器731A所驱动并作为低阻抗信号Vw。由电阻分压器(由R1、R2以及R3组成)建立了Vw信号的补偿，其中电  阻分压器还产生保险信号(G)的电压，而保险信号是和工作电极(W)具有相同电位或电压的信号。 
在一种具体实施方式中，利用运算放大器731B的伺服系统驱动反电极(C)电压到传感器，以使参考电极(R)处于由电阻分压器(由R1、R2以及R3组成)设置的第二数值。这保持工作电极(W)电压高于参考电极(R)设定量，其称作“平衡电压”(“PoiseVoltage”)(即40mV)。旁路电容器(Cb)可以是较小的、低等效串联电阻(ESR)电容器，如0.1uF(100nF)多层陶瓷(MLC)电容器，其起作用以提供局部能量并降低电路上的噪声。用于此电路的电压源可以由V+和V-之间的电位差来提供，例如，V+可以是5V而V-可以是接地(GND)或V+可以是+3V而V-可以是-3V。 
在一种具体实施方式中，运算放大器731A、731B可以是在单个、较小8管脚、表面安装技术(SMT)封装中的双运算放大器集成电路(IC)如在SOT23-8封装中的OPA2349(3mm×3mm)。利用诸如“倒装法”和引线结合的技术，可以获得类似的双运算放大器产品，甚至在更小的球栅阵列(BGA)封装中以及作为裸芯片(baredie)，其可以直接安装至电路基板，如印刷电路板(PCB)或柔性电路。 
图8A-8C分别示出了供连续分析物监测系统之用的无源传感器构造，以及在根据本发明的一种具体实施方式的集成输液装置和监测系统的患者界面处使用的有源传感器构造的两种具体实施方式。参照图8A，分析物传感器810包括工作电极811、安全走线(guard trace)812、参考电极813、以及反电极814。在一种具体实施方式中，分析物传感器810的“尾”段815被构造成皮下定位在患者皮肤下面，从而与患者液体接触。 
现在参照图8B，分析物传感器820设置有模拟前置部分821，其中根据一种具体实施方式示出的四个触点是V+、V-、Vw、以及Vc信号，分别代替工作电极811、安全走线812、参考电极813、以及反电极814。以这种方式，在本发明的一种具体实施方式中，有源分析物传感器820的这些信号具有低阻抗，因而比无源传感器信号较小受到噪声的影响。此外，在一种具体实施方式中，分析物传感器820构造可以包括柔性电路。 
现在参照图8C，在另一具体实施方式中，示出了一种有源传感器，其具有和图8B的有源传感器820类似的结构但具有小得多的尺寸。更具体地说，分析物传感器830设置有四个触点，其被构造用于直接引线结合而不是机械接触系统，如由在先前示于图8A-8B的两种传感器构造上的较大接触表面所指示的。因为减小了分析物传感器830的形状，所以传感器830可以缠绕在插管(例如，图4的插管470)的周围，因而仅需要单个进入部位，用于患者分析物监测和胰岛素输注。此外，在本发明的范围内，可以提供另外的传感器/插管构造，其中传感器电路和插管是作为单个组件如电路831制备在表面上的插管。 
图9示出了根据本发明的一种具体实施方式的集成输液装置和分析物监测系统，其中输液装置和监测系统发送器结合到由患者戴用的单个贴剂中。参照图9，集成输液装置和分析物监测系统900包括设置在粘合层960上的集成贴剂泵和发送器单元910，并且其被构造成放置在患者皮肤上，以便将插管950和分析物传感器940牢固地皮下定位在患者皮肤下面。在一种具体实施方式中，集成输液泵和发送器单元910的外罩被构造成包括输注机构，其借助于插管950将药剂如胰岛素递送到患者。 
此外，集成贴剂泵和发送器单元910被构造成通过无线通信路径930如RF链路传输与由分析物传感器940测得的分析物水平有  关的信号。这些信号被从身体上的集成贴剂泵和发送器单元910传输到控制单元920，其被构造成控制集成贴剂泵和发送器单元910的操作，以及从集成贴剂泵和发送器单元910接收传输的信号，其对应于检测到的患者的分析物水平。 
回到图9，在一种具体实施方式中，集成贴剂泵和发送器单元910的输注机构可以包括在美国专利第6,916,159号(授予给本发明的代理人，Abbott Diabetes Care，Inc.)中所描述类型的输液装置。此外，虽然在图9中示出了通过通信路径930的无线通信，但可以用一组导线来代替无线通信路径930以提供到控制单元920的有线连接。 
以这种方式，在本发明的一种具体实施方式中，集成输液装置和分析物监测系统900并不使用输液管，通过无需另外戴用不方便的输液管，其可以为患者提供另外的舒适度和方便。 
图10是根据本发明一种具体实施方式的集成有分析物监测系统传感器电极的输液装置插管的详图。参照图10，其示出了输液装置插管，而分析物传感器电极1020设置在其中，并安装到粘附贴剂1010，以便将它的位置牢固地保持在患者中。更具体地说，如从图10可以看到的，带有分析物传感器电极1020的插管包括传感器电极1021、1022、1023(其可以分别对应于工作电极、参考电极以及反电极)，其每一个设置在插管尖端1020内，并且另外，被定位以便保持与患者的分析物液体接触。 
图12A-12C各自示出了分别根据本发明不同具体实施方式结合有图10的连续分析物监测系统传感器电极的输液装置插管的剖视图。参照图12A，在一种具体实施方式中，导线和管是平行设置的，使得管壁1220、用于胰岛素流动的管芯1224、导线外套管1220以及单根绝缘导线1221、1222、1223基本上如图12A所示。更具  体地说，从该附图可以看到，三根绝缘导线中的每一根均设置有管壁的绝缘层1220，其独立地围绕每根绝缘导线1221、1222、1223，并且另外，其中三根绝缘导线1221、1222、1223本身被管壁1220所包围。 
现在参照图12B，在本发明的一种具体实施方式中，分别连接于传感器电极的绝缘导线1221、1222、1223被共挤压成管壁1220，其中用于胰岛素递送的管芯1224和绝缘导线1221、1222、1223的构造基本上如图12B所示。现在参照图12C，在本发明的又一具体实施方式中，每根绝缘导线1221、1222、1223环绕管1220并覆盖有护套1210，因而提供管壁1220、用于胰岛素递送的管芯1224、单个绝缘导线1221、1222、1223、以及外保护护套1210，其还可以用作电磁屏蔽以消除电子噪声，基本上如附图所示。 
再次参照这些附图，示于图12A和图12C的具体实施方式可以具有更大的横截面积(因此需要在患者皮肤上穿刺更大的孔)，然而也许更容易制造、更可靠以及更容易连接到分析物传感器电子设备。另外，在本发明的范围内，沿着传感器和泵之间的胰岛素递送管可以提供光数据传输(即，光纤技术)而不是如上所述的集成导线。 
图11A示出了根据本发明的另一种具体实施方式的结合有分析物监测系统传感器电极的输液装置插管的部件透视图，而图11B示出了根据本发明的一种具体实施方式的结合有输液装置的分析物监测系统发送器单元的俯视平面图。参照图11A-11B，在本发明的一种具体实施方式中，集成分析物传感器和输液装置插管1100包括5个薄片层(层压层，laminated layer)，其包括顶部绝缘层1101、电极迹线(electrode trace)设置在其上的导电层1102、接着是具有集成输液插管的三层基片1103。 
在一种具体实施方式中，具有集成输液插管的三层基片1103包括：分离/绝缘层1103A，其使传感器电极和输液插管绝缘；通道层1103B，其构造成引导胰岛素或任何其它适宜药剂的流动；以及入口/出口层1103C。图11A中还示出集成分析物传感器和输液装置插管1100的装配图。 
现在参照图11B，可以看到，如在一种具体实施方式中所示的贴剂泵设置有发送器单元1110以及胰岛素泵1130，其连接于胰岛素容器1120，并可操作地连接或安装于发送器单元1110。图11B中还示出了分析物传感器触点1140，其被构造成与集成输液插管和分析物传感器1100的各个电极建立电接触。图11B中还示出了胰岛素端口1150，其连接于集成输液装置插管和分析物传感器1100的通道层1103B。 
以这种方式，在本发明的一种具体实施方式中，贴剂泵可以被患者戴用在皮肤上并且其包括胰岛素输注机构以及分析物传感器和发送器单元。 
图13是定时图，用于说明在一种具体实施方式中由集成输液装置和监测系统进行的血糖测量和胰岛素递送的时间间隔。更具体地说，胰岛素泵通常以周期方式递送胰岛素，其中递送周期在2至3分钟的范围内并且在每个周期递送的持续时间大约为几秒或更短。每个周期递送的胰岛素量可以随所希望的总胰岛素递送速率而变化。连续收集分析物数据(作为，例如，葡萄糖氧化的连续电流)，但通常周期地报告给使用者。分析物报告周期通常是1至10分钟并且需要收集葡萄糖氧化电流10至30秒，以便产生可报告的葡萄糖数值(以便于过滤等)。 
确实，分析物监测和胰岛素递送的结合有必要使分析物传感器的放置位置非常接近在身体上的胰岛素输液插管。这样的非常接近  使得胰岛素递送有可能干扰分析物测量。例如，如果胰岛素输注将导致输注部位附近体内区域的葡萄糖浓度的局部降低，那么在此区域的葡萄糖测量结果将不代表整个体内的葡萄糖浓度。因此，在本发明的一种具体实施方式中，提供了一种将血糖测量和胰岛素递送在时间上隔开的方法，以缓和胰岛素输注和葡萄糖测量之间的可能干扰。 
根据一种具体实施方式，分析物测量和胰岛素递送的时间间隔可以包括提供从胰岛素递送以后至进行分析物测量之前的大的时间间隔。因为分析物测量和胰岛素递送均是周期性进行的，所以如果在胰岛素递送之前基本上立即进行分析物测量则可以实现最大时间间隔。在胰岛素递送和其后葡萄糖测量之间的期间，输注的胰岛素有时间扩散并被传输离开输注部位(由于间隙液的正常循环)。图13示出了时间上隔开的分析物测量和胰岛素递送的时间线的一个实例。如果在胰岛素递送点之间进行多个分析物测量，则应当总是有刚好在胰岛素递送之前以及刚好在胰岛素递送以后的读数，以将注射胰岛素对葡萄糖测量读数的影响降到最小程度。 
虽然为了简化处理通常周期地获得读数，但读数可以与其它读数不同时读取并约略测量总读数平均值。类似地，可以稍微延迟胰岛素递送点直到读数具有很小或没有影响以后，如读数比输注通常更频繁发生的，其用来作用更长的一段时间。此外，可以考虑其它定时需要考虑的问题，其取决于患者使用集成输液装置和分析物监测系统的环境，在本发明的范围内，以将测得的分析物水平的潜在误差降至最小程度，和/或最大程度降低噪声的引入或对输液装置的输液速率的潜在有害影响。 
更具体地说，输液装置和/或分析物监测系统的电源(包括，例如，电池或相关配电电路)的波动可以引入电噪声效应，其可以有害地影响测得的与分析物监测系统有关的读数。例如，当分析物监测系统被构造成处于活动状态从而传输或接收数据时，或当输液装置的泵送周期运行时，电源可以受到来自数据传输/接收、或泵送周期的影响。除来自电子电路的其它部件的噪声以外，电源的有害影响可以引入不希望的噪声并有害地影响分析物传感器测量结果的准确性。
因此，例如发送器单元150(图1)可以被构造成监测测得的分析物水平(接收自分析物传感器160)的定时或发生以及发送器单元150的数据传输定时，以使两个事件基本上不会重叠或发生在基本上相同的时间。可替换地，分析物监测器单元120(图1)可以被构造成比较分析物传感器160测量的定时和数据传输(来自发送器单元150)的定时，以及除去这样的分析物相关数据，其接收自发送器单元150并与分析物测量(通过分析物传感器160)的定时同时发生。 
此外，在一种具体实施方式中，通过监测液体移动可以检测胰岛素管中的气泡，其也可以检测液体的缺少如起因于管线中的气泡。在一种具体实施方式中，流量传感器可以被构造成当气泡存在时产生零电流。 
此外，胰岛素的着色可供检测管中的气泡。因为药物胰岛素是透明无色液体，所以难以在视觉上区别管中的胰岛素和空气，其中所述管将胰岛素从胰岛素泵运送到插管。通过向胰岛素提供色调，将更容易视觉上识别管中的气泡并且能够在它们引起问题以前将它们除去。在一种具体实施方式中，胰岛素色调(tint)是生物相容的以及胰岛素相容的。 
因此，在本发明的一种具体实施方式中，包括输液装置和分析物监测单元的系统包括：输液装置；身体上的单元，其包括数据传输部分，所述身体上的单元进一步连接于输液装置，所述身体上的  单元被构造成接收对应于一个或多个分析物水平的一个或多个信号，而且，所述身体上的单元构造成输注从输液装置接收的液体；以及接收器单元，其可操作地连接于身体上的单元，所述接收器单元构造成接收来自身体上的单元的数据，其中接收的数据与分析物水平有关。 
该系统可以进一步包括分析物传感器，至少其第一部分与患者的分析物液体接触，而且，其中至少分析物传感器的第二部分与数据传输部分信号通信。 
在一种具体实施方式中，数据传输部分可以被构造成基本上周期性地在一个或多个预定时间间隔传输对应于一个或多个分析物水平的一个或多个信号，其中上述一个或多个预定时间间隔可以包括一个或多个30秒、1分钟、或90秒。 
在一个方面，身体上的单元可以包括插管，至少其一部分皮下定位在皮肤层下面，并且进一步还可以包括输液管，该输液管连接于输液装置以将液体递送到身体上的单元。在另一方面，可以以基本上不透水密封的方式连接输液管和身体上的单元。 
在又一具体实施方式中，输液管可以被构造成可操作地连接于插管从而递送液体。 
身体上的单元可以被构造成将对应于一个或多个分析物水平的一个或多个信号无线传输到接收器单元，其中身体上的单元和接收器可以被构造成通过RF通信链路、蓝牙通信链路、或红外通信链路中的一种或多种进行无线通信。 
此外，在另一具体实施方式中，输液装置可以被构造成基于对应于一个或多个分析物水平的一个或多个信号(由接收器单元接收)来控制液体的递送速率，并且另外，其中输液装置可以被构造 成基于与对应于一个或多个分析物水平的一个或多个信号有关的信息来确定修正的(改进的)用于递送液体(如胰岛素)的递送方案(protocol)。 
在又一方面，修正的递送方案可以包括矫正推注、修正的基础方式、碳水化合物推注、追加推注、或其组合中的一种或多种。 
在一种具体实施方式中，接收器单元可以被构造成与输液装置无线通信。 
在另一具体实施方式中，接收器单元可以结合到输液装置的外罩中。 
在本发明的另一种具体实施方式中，结合分析物监测和液体输注的方法包括：以预定递送速率输注液体，检测一个或多个分析物水平、传输与测得的一个或多个分析物水平有关的一个或多个信号，以及基于传输的一个或多个信号来确定修正的(改进的)递送速率。 
在一个方面，可以在检测有关的一个或多个分析物水平之后基本上立即传输上述一个或多个信号。 
此外，在一种具体实施方式中，传输步骤可以包括通过RF通信链路、蓝牙通信链路、红外通信链路、或其组合中的一种或多种来无线传输一个或多个信号。 
在另一方面，上述方法还可以包括以下步骤：接收传输的一个或多个信号，以及显示接收的一个或多个信号。 
此外，上述方法还可以包括显示修正的递送速率的步骤。此外，该方法还可以包括实施修正的递送速率的步骤，其中预定递送速率可以包括一个或多个基础递送速率。 
在另一具体实施方式中，修正的递送速率可以包括矫正推注、修正的基础方式、碳水化合物推注、追加推注、或其组合中的一个或多个。 
在本发明的另一具体实施方式中，包括分析物传感器和液体递送通道的装置包括液体递送单元，该单元具有内壁和外壁，以及设置在液体递送单元的内壁和外壁之间的多个电极，其中液体递送单元的一部分以及多个电极的一部分皮下定位在皮肤层的下面。 
在一个方面，多个电极可以包括分析物传感器，其包括例如，工作电极、反电极、参考电极、或其组合中的一个或多个。 
液体递送单元可以包括用于递送液体如胰岛素的通道，该通道基本上由内壁形成。 
根据本发明的又一具体实施方式，包括分析物传感器和液体递送通道的装置包括具有第一管通道的第一管，以及具有第二管通道的第二管，其包括设置在第二管通道内的多个电极，其中至少第一管的一部分和至少第二管的一部分皮下定位在皮肤层下面。 
在一种具体实施方式中，上述多个电极可以基本上和完全彼此绝缘。 
在另一种具体实施方式中，可以整体形成第一管和第二管，以使第一管的外表面基本上与第二管的外表面接触。 
根据本发明的又一具体实施方式，包括输液装置和分析物监测单元的系统包括：输液和监测装置；包括数据传输部分的身体上的单元，该身体上的单元进一步连接于输液和监测装置，该身体上的单元被构造成接收对应于一个或多个分析物水平的一个或多个信号，并且另外，该身体上的单元成被构造成输注从输液和监测装置接收的液体；以及连接器，其在第一端连接于输液装置并在第二端连接于身体上的单元，该连接器被构造成将液体从输液装置引导到身体上的单元，并且另外，构造成向输液和监测装置提供对应于一个或多个分析物水平的一个或多个信号。 
在一个方面，输液和监测装置可以成被构造成将液体递送至患者，并且进一步，在预定时间内检测患者的分析物水平。 
在另一方面，输液和监测装置可以包括连续葡萄糖监测系统。 
在又一个方面，输液和监测装置可以包括胰岛素泵。 
根据本发明的另一具体实施方式，液体递送和分析物监测的方法包括确定用于液体输注的递送方式(delivery profile)，其中递送方式包括每个在时间上由预定时间隔开的多个预定离散的液体输注，以及基本上在每个预定离散的液体输注以前立即对分析物水平进行采样。 
该方法可以进一步包括基本上在每个预定离散的液体输注以后立即对分析物水平进行采样的步骤。 
对本领域技术人员来说，在不偏离本发明的范围和精神的情况下，对本发明的结构和操作方法的各种其它改进和更改将是显而易见的。虽然已连同特定的优选具体实施方式对本发明进行了描述，但应当理解，如要求的本发明不应不适当地限制于这样的特定具体实施方式。 

Claims (34)

1.一种用于集成输液系统与分析物监测系统的系统，包括：外罩，包括用户界面；
输液装置，设置在所述外罩内并且构造成控制液体的递送速率；
身体上的单元，包括分析物传感器以及与所述分析物传感器进行信号通信的数据传输部分，其中所述分析物传感器连续测量包括液体递送前基本上立即的分析物水平的分析物水平，并且其中所述数据传输部分构造成传输从所述分析物传感器接收的对应于分别的一个或多个分析物水平的一个或多个信号；以及
可操作地连接于所述身体上的单元上的接收器单元，其中，所述接收器单元接收来自所述身体上的单元的传输的所述一个或多个信号，处理所接收的所述一个或多个信号以产生基于基本上实时的葡萄糖数据的葡萄糖趋势数据，并与所述输液装置通信，以根据至少部分地基于所述基本上实时的葡萄糖数据或所述葡萄糖趋势数据并进一步响应经由所述用户界面接收的用户输入而修正的基础方式来编程所述输液装置递送所述液体；
其中，所述用户界面包括显示器以输出所述基本上实时的葡萄糖数据、所述葡萄糖趋势数据或所述液体的递送速率中的一种或多种。
2.根据权利要求1所述的系统，其中所述分析物传感器包括至少第一部分和第二部分，其中所述第一部分与间隙液进行液体接触，其中所述第二部分与所述数据传输部分进行信号通信。
3.根据权利要求1所述的系统，其中，所述数据传输部分被构造成基本上周期地以一个或多个预定时间间隔传输对应于分别的一个或多个分析物水平的所述一个或多个信号。
4.根据权利要求3所述的系统，其中，所述一个或多个预定时间间隔包括30秒、1分钟、或90秒中的一个或多个。
5.根据权利要求1所述的系统，其中，所述身体上的单元包括插管，所述插管的至少一部分皮下定位在皮肤层下面。
6.根据权利要求5所述的系统，进一步包括输液管，所述输液管连接于所述输液装置以将所述液体递送到所述插管。
7.根据权利要求6所述的系统，其中，所述输液管和所述身体上的单元以基本上不透水密封的方式相连接。
8.根据权利要求6所述的系统，其中，所述输液管被构造成可操作地连接于所述插管以递送所述液体。
9.根据权利要求1所述的系统，其中，所述身体上的单元被构造成将对应于所述分别的一个或多个分析物水平的所述一个或多个信号无线传输到所述接收器单元。
10.根据权利要求9所述的系统，其中，所述身体上的单元和所述接收器单元被构造成通过RF通信链路、蓝牙通信链路、或红外通信链路中的一种或多种进行无线通信。
11.根据权利要求1所述的系统，其中，所述输液装置被构造成基于对应于所述分别的一个或多个分析物水平的、由所述接收器单元接收的所述一个或多个信号来控制所述液体的递送速率。
12.根据权利要求11所述的系统，其中，所述输液装置被构造成基于与对应于所述分别的一个或多个分析物水平的所述一个或多个信号有关的信息来执行修正的用于递送液体的递送方案。
13.根据权利要求12所述的系统，其中，所述液体是胰岛素。
14.根据权利要求12所述的系统，其中，所述修正的递送方案包括矫正推注、修正的基础方式、碳水化合物推注、追加推注、或其组合中的一种或多种。
15.根据权利要求1所述的系统，其中，所述接收器单元被集成到所述外罩中。
16.根据权利要求1所述的系统，其中，所述接收器单元被进一步构造成：
比较对应于所述分别的一个或多个分析物水平的所述一个或多个信号传输的定时与通过所述分析物传感器的分析物水平的测量的定时；以及
当所述一个或多个信号传输的定时基本上对应所述分析物水平的测量的定时时，除去与所述分析物水平的测量对应的数据。
17.根据权利要求1所述的系统，其中，所述接收器单元与所述身体上的单元的所述数据传输部分双向通信。
18.根据权利要求1所述的系统，其中，所述分析物传感器在液体递送之后基本上立即测量分析物水平。
19.一种用于集成输液系统与分析物监测系统的系统，包括：
输液装置，设置在具有用户界面的外罩内，所述用户界面包括显示器，其中所述输液装置控制液体的递送速率；
身体上的单元，包括分析物传感器、插管以及数据传输部分，其中所述分析物传感器连续监测包括在液体递送之前基本上立即的葡萄糖水平的葡萄糖水平，其中所述分析物传感器与所述数据传输部分信号通信；
接收器单元，集成在所述外罩上，其中所述接收器单元与所述身体上的单元的所述数据传输部分双向通信，其中所述接收器单元接收来自所述数据传输部分的对应于分别的一个或多个葡萄糖水平的一个或多个信号，处理所接收的所述一个或多个信号以产生基于基本上实时的葡萄糖数据的葡萄糖趋势数据，并基于所述基本上实时的葡萄糖数据和所述葡萄糖趋势数据以及进一步响应经由所述用户界面接收的用户输入来编程所述输液装置递送所述液体；
其中，所述基本上实时的葡萄糖数据、所述葡萄糖趋势数据或所述液体的递送速率中的一种或多种在所述用户界面的显示器上输出。
20.根据权利要求19所述的系统，其中，所述分析物传感器包括至少第一部分和第二部分，其中所述第一部分与间隙液进行液体接触，其中所述第二部分与所述数据传输部分进行信号通信。
21.根据权利要求19所述的系统，其中，所述数据传输部分被构造成基本上周期地以一个或多个预定时间间隔传输对应于所述分别的一个或多个葡萄糖水平的所述一个或多个信号。
22.根据权利要求21所述的系统，其中，所述一个或多个预定时间间隔包括30秒、1分钟、或90秒中的一个或多个。
23.根据权利要求19所述的系统，其中，所述分析物传感器在液体递送之后基本上立即测量葡萄糖水平。
24.根据权利要求19所述的系统，其中，所述插管的至少一部分皮下定位在皮肤层下面。
25.根据权利要求19所述的系统，进一步包括输液管，所述输液管连接于所述输液装置以将所述液体递送到所述插管。
26.根据权利要求25所述的系统，其中，所述输液管和所述身体上的单元以基本上不透水密封的方式相连接。
27.根据权利要求19所述的系统，其中，所述插管和所述分析物传感器集成为单个单元。
28.根据权利要求19所述的系统，其中，所述身体上的单元的所述数据传输部分被构造成将对应于所述分别的一个或多个葡萄糖水平的所述一个或多个信号无线传输到所述接收器单元。
29.根据权利要求28所述的系统，其中，所述身体上的单元的数据传输部分和所述接收器单元被构造成通过RF通信链路、蓝牙通信链路、或红外通信链路中的一种或多种进行无线通信。
30.根据权利要求19所述的系统，其中，所述输液装置被构造成基于对应于所述分别的一个或多个葡萄糖水平的、由所述接收器单元接收的所述一个或多个信号来控制所述液体的递送速率。
31.根据权利要求30所述的系统，其中，所述输液装置被构造成基于与对应于所述分别的一个或多个葡萄糖水平的所述一个或多个信号有关的信息来执行修正的用于递送液体的递送方案。
32.根据权利要求31所述的系统，其中，所述修正的递送方案包括矫正推注、修正的基础方式、碳水化合物推注、追加推注、或其组合中的一种或多种。
33.根据权利要求19所述的系统，其中，所述液体是胰岛素。
34.根据权利要求19所述的系统，其中，所述接收器单元被进一步构造成：
比较对应于所述分别的一个或多个葡萄糖水平的所述一个或多个信号传输的定时与通过所述分析物传感器的葡萄糖水平的测量的定时；以及
当所述一个或多个信号传输的定时基本上对应所述葡萄糖水平的测量的定时时，除去与所述葡萄糖水平的测量对应的数据。
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