CN1449840A - 遥控药物输注和分析物监视的系统和方法 - Google Patents

遥控药物输注和分析物监视的系统和方法 Download PDF

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CN1449840A
CN1449840A CN03110722A CN03110722A CN1449840A CN 1449840 A CN1449840 A CN 1449840A CN 03110722 A CN03110722 A CN 03110722A CN 03110722 A CN03110722 A CN 03110722A CN 1449840 A CN1449840 A CN 1449840A
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pump
user
remote control
patient
physiological liquid
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A·D·拜伦
W·J·杜尔班
M·D·瓦德勒
K·M·隆
J·麦克克卢斯基
U·克拉夫特
M·埃布纳
M·施泰尼
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LifeScan Inc
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Abstract

本发明提供一种通过药物注液泵，例如一个皮下注液泵，遥控病人的药物输送，和通过一个经皮测量装置遥控和监视一个或多个生理液分析物的装置，系统，和方法。本发明的系统包括一个药物注液泵和一个用于遥控注液泵和/或测量装置的手持表链。除了遥控胰岛素泵和测量装置，表链提供了在一段时间内的血液化学特性数据和胰岛素输送数据的联合并保持这个联合数据以便用户或医生立即和以后取回。本发明的方法是，通过计入或补偿用户当前的或实际当前的血液化学特性评估和/或用户预期的和/或实际的碳水化合物摄取量而使用户定制和最佳化胰岛素食团输送规约，即，食团量和输送持续时间。

Description

遥控药物输注和分析物 监视的系统和方法
技术领域
本发明涉及连续输送的药物输注系统和生理液特性监视系统。特别是，本发明涉及这种连续/输送的药物输注系统和生理液特性监视系统的用户一交互性遥控，以及在遥控装置中集成这种生理液特性监视系统。
背景技术
药物输注装置和生理液特性监视装置在医学界是公知的。这种装置的一个公共应用是输送胰岛素和监视糖尿病患者的血液葡萄糖水平。近年有很多进展，和这种装置结合起来而形成一个合用装置，该合用装置根据实时病人血液葡萄糖水平和其它要求控制对病人的胰岛素输送。
一个这样的装置在美国专利U.S.5,665,065号中被公开了，它提供一个自动注液泵，以便连续地，按程序地输送胰岛素到病人的皮下部位。根据一个预定规约，该泵被设计成，经过一个注入管子从贮液器到病人程序可控地输送胰岛素。泵的外壳包括一个集成的血液传感器，用以获得病人的当前的血液葡萄糖水平。除了当前的血液的化学数据而外，该装置用以接收与特定事件的病人活动有关的病人的数据，例如，病人锻炼或进餐时刻表的变化，或预期摄取食物的增减，这些可能影响病人当前血液的化学特性。这种特定事件数据和血液数据被提供给一个安装在泵监视装置中的中心控制器信息处理机，它可以自动修改胰岛素输送规约，对胰岛素的剂量和用泵输送这个剂量的时间选择进行必要的变化。
虽然这种高度自动化的装置具有许多优点，许多病人还是想要直接控制药物的配给。例如，病人可能要求在药剂输送期间停止药物的配给，即使在最初的配给是由病人开始的，而不是根据预定程序算法开始的场合。可能有这样的情况，例如，糖尿病患者预期摄取的碳水化合物发生变化，例如，在进餐中，病人发现自己吃进的碳水化合物的数量大于或小于餐前预期的量。这种情况要求立即修改实际用泵输送的当时的当前胰岛素输送参数。
因此，继续对用泵进行病人控制药物输送的新装置和新方法的研究感兴趣，它对适应每个病人的实时的，即时的需要，适应药物的实时输送的特殊控制提供了更大的灵活性。特别感兴趣的是这样一种病人控制药物输送系统的研制，它提供给病人这样的灵活性和控制能力而增加了方便性和使用容易，加强了便携性和在需要与药物输送系统接口时提高了病人的稳私性。
发明内容
提供一种通过药物注液泵例如是一个皮下注液泵，遥控病人的药物输送，和/或通过一个经皮生理液监视装置遥控生理液，例如是病人的血液或间隙流体的测量的装置，系统和方法。本发明的系统包括一个手持“表链”，它用于遥控注液泵和/或监视装置。注液泵和监视装置可以分开安装或合在一起装入一个单一的外壳中。
注液泵包括一个药物贮液器和一个用于分配贮液器的药物的驱动电机。注液泵可以进一步包括一个电源和一个电池，一个报警器，一个数字显示器，一个具有微处理机以便控制泵的操作和泵通信功能的泵控制器，一个用于双向连通表链和其它装置的通信模块，一个用于短期或长期存储数据的存储器，和控制键，用于记入或选择显示器上显示的菜单的数据或参数。
生理液监视装置包括一个液体采样装置，用于存取和收集人的血液或间隙流体，包括一个特征测量装置，用于监视一个或多个特征，例如，采样液体的分析物。采样和后来的监视生理液可能实现上是连续进行的。生理液监视装置可能进一步包括一个电源和一个电池，一个报警器，一个数字显示装置，一个与表链和其它设备双向通信的通信模块，短期或长期存储数据的存储器，和用户接口控制键，用于使用户记入或选择显示器上显示的菜单的数据或参数。生理液监视装置进一步包括一个控制器，它具有一个微处理机以控制采样操作，包括测量装置，它经通信模块控制信号接收和传输，在监视装置中各组成部分之间处理和传递数据。生理液监视装置的一个特点是，它能被程序化，以便提供生理液的连续的，不断进行的存取，收集和测量，而不需要人的干予。
表链包括遥控泵和/或生理液连续收集的装置和监视装置。可选择地，表链也可以包括一个“不连续的”或短暂的生理液测量仪。表链具有一个试验片条端口以便接收，用仪器短暂测量病人血液采样的血液葡萄糖浓度的试验片条。表链还包括用户遥控注液泵和生理液收集装置的部分，包括一个表链控制器，它具有一个微处理机，用于控制泵和仪器操作功能，和一个通信模块，用于传送泵的操作，一个显示器和控制键，用于泵的数据的记入，选择和传送，和生理液收集装置，存储这些数据的存储器。
本系统优于许多传统的胰岛素输送和监视系统的优点在于，在很小的，独立的表链中，合并了短暂血液化学仪和很分散的，遥控胰岛素泵的零部件和/或连续测量分析物试验器。除了遥控胰岛素泵和连续/测量分析物试验器，表链提供了在一段时间上的血液化学数据和胰岛素输送数据的联合并保持这个联合数据以便用户或医生立即和以后取回。这样，所有关键信息和影响病人治疗的事件的综合分析可以被做出。
本系统的特点带来的优点在于，它使用户在监视和控制血液葡萄糖水平中具有广泛的灵活性。特别是，本系统使用户有能力改变食团和在任何时间上的基本定量输送缺省参数。通过软件算法控制和调整药物食团提供了许多这种灵活性。
为了更好地处理用户直接的和发展中的要求，本发明通过计入或补偿用户当前的或实际上当前的血液化学评估和/或用户的预期的和/或实际的碳水化合物摄取量，而使用户定制一个胰岛素食团输送规约，即，食团的体积和输送持续时间。特别是，本发明提供了三种计算器功能选择，即碳水化合物计算器功能，血液葡萄糖计算器功能和联合计算器功能，它允许用户选择考虑血液化学特性和碳水化合物的任一个或两者，以及其它因素，例如在执行食团输送规约以前用户进行的锻炼。进行这样的计算的某些参数是缺省值，例如，食团与碳水化合物的比，食团与血液葡萄糖的比，和用户的目标血液葡萄糖水平，它们已被予先编制程序到系统控制器中，而其它参数，例如，用户实际血液葡萄糖水平，将要消耗的碳水化合物的数量，和食团剂量校正因素，将由用户实时记入。
本发明的方法包括用表链装置遥控药物胰岛素泵和生理液监视装置，如上所述。这种遥控包括在泵和表链之间和在监视装置和表链之间(和在泵和监视装置之间进行选择)的“符号交换”，其中，数据和指令经过它们各自的通信模块在各个装置之间来回传送。
这些方法可以包括实现各种食团输送算法的一个或多个，这些算法包括，标准食团输送算法，展开食团输送算法和双食团输送算法。上述每一种算法可以用或不用上述计算器功能来实现，以便定制和最佳化在任一给定时间上的每个食团输送规约。
通过阅读下面的本发明的方法和系统的详细说明，本发明的这些和其它目的，优点，和特点对于那些本领域的普通技术人员来说会变得更明显。
附图说明
图1是本发明的一个系统，它具有一个病人佩带的便携药物输送泵和一个血液特性仪，做成遥控装置用于控制所述仪器和泵的功能。
图1A是沿图1中A-A线截取的图1的泵的视图。
图1B是沿图1中B-B线截取的图1的遥控仪装置的视图。
图2是图1系统的方块图。
图3A是本发明标准食团输送算法的流程图。
图3B是本发明展开食团输送算法的流程图。
图3C是本发明双食团输送算法的流程图。
图4A是本发明碳水化合物计算器方式算法的流程图。
图4B是本发明血液葡萄糖计算器方式算法的流程图。
图4C是本发明碳水化合物/血液葡萄糖计算器方式算法的流程图。
图5是本发明的方法的流程图。
图6是本发明的另一个系统，它具有病人佩带的便携连续生理液监视器，和控制该监视器功能的遥控装置，该遥控装置还提供一个用于生理液监视的积分仪。
图7是图6的系统的连续生理液监视器，它包括一个和该监视器一起使用的可自由使用的卡盘(cartridge)。
图8是图7的卡盘的放大透视图。
图9是图6系统的方块图。
图10是本发明另一系统的方块图，它包括一个便携药物输送泵，一个连续生理液监视器，和一个控制输送泵和监视器的功能的遥控器。
具体实施方式
在对本发明进行描述以前，应该理解，本发明不限于所描述的具体实施例，它们是可以变化的。同样也应该理解，这里所用术语只是为了描述具体的实施例而不是限制本发明，本发明的范围仅由所附权利要求来限定。
当提及值的范围时，应该理解，对于下限单位十位以内的每个插入值，如果没有上下文明确规定，就是在这个范围的上限和下限之间，任何其它规定的，或在那个规定范围中的插入值被包括在本发明之中。能够独立地包括在小范围之中的小范围的上限和下限也包括在本发明之中，服从在规定范围之中的任何特殊的除外界限。在规定范围包括一个或两个限界的地方，排除任一或两个所包括界限的范围也包括在本发明之中。
除非有规定，这里使用的技术与科学术语具有熟悉本发明技术的普通人员所一般理解的相同意义。虽然任何类似于或等于这里所描述的方法和资料也能被用于实践或试验本发明，现在描述最佳方法和资料。
必须指出，如这里和权利要求书中所使用的，单数冠词“a”，“an”和“the”包括多种对象，除非上下文明确规定。因此，例如，“a test strip”(一试验片条)包括多个这样的试验片条，“the device”(一设备)包括一个或多个本领域普通技术人员所知道的设备和其等价物，等等。
这里所讨论的那些公开物，只是因为它们是在本申请申请日以前公开的。这些先前的公开物不会影响本发明的授权。此外，所提供的公开日期可能与实际公开日期不同，实际公开日期需要被独立地证实。
现在将详细描述本发明，在进一步描述本发明的时候，主题系统和设备组成部分将首先描述，其次使用的主题设备和系统的各种方法，以及控制生理采样特性的试验和控制药物输送给病人的方法也将被描述。最后简短描述所提供的主题成套部件，这些成套部件包括在实践主题方法中使用的主题设备和系统。
在下面的描述中，本发明将描述葡萄糖浓度测量和胰岛素输送应用；不过，这不限制本发明，本领域普通技术人员将理解，主题设备，系统和方法在测量其它物理和化学特性中是有用的，例如生物物质的凝血时间，胆固醇血的水平等，在输送其它药物中也是有用的，例如疼痛控制药物，抗菌素，在化学疗法和营养疗法中也是有用的。
系统和设备
现在参考图1和2解释本发明的系统，它具有一个注液泵4和一个遥控装置6，一般称为“表链”(fob)。图1A沿线A-A示出了泵4的顶视图。图1B沿线B-B示出了装置6的侧视图。图2是泵4和表链6的方块图和它们各自的组成部分。图6-9是本发明的另一个系统，它具有生理液监视装置300和表链350。图6-8是系统的组成部分的外部视图，图9与图10一道，提供了监视装置300和表链350的方块图。图10是本发明的另一个系统，它包括泵和监视装置。
注液泵
注液泵4具有一个外壳8，它最好是用耐用的塑料材料制成，它有一个部分8a，适用于接收或容纳注射器或贮液器(未示出)，贮液器贮存配给病人的规定的药物，配给病人药物是通过一个留置导管10进行的。外壳8最好足够小型紧凑以便用户舒适地，单独地携带，例如，通过一个腰带夹子等进行携带。一般，外壳8的长度Lp是在约2.5到5英寸的范围内，更典型的是约3英寸到约3.5英寸，高Hp是在约1.5至约3英寸的范围内，更一般的是从约2英寸到约2.5英寸，厚Tp在约0.5到约1.5英寸的范围内，更一般的是从约0.75到约1英寸。虽然泵4实际上是长方形或正方形的，它也可以是任何合适的形状，例如，园形，长椭园形等等。
注液泵4包括许多与现有技术注液泵相同的基本的组成部分和结构，例如在下述美国专利中公开的那些，这些美国专利的专利号是，4,562,751；4,678,903；5,080,653；5,097,122；5,935,099；6,248,093B1和6,406,605B1，这些美国专利被引入作为参考。这些基本部件包括一个药物贮液器50和一个驱动电机52，它使用一个引导螺旋部件，以便电机驱动贮液器活塞(未示出)前进，使药物退出泵的出口而进入注液管10；不过，其它合适的从贮液器50分配药物的机制也可能被使用，例如，电渗流(也称动电流)。因此，电源62和电池64被提供，以便提供必要的电力去操作泵4的各组成部件。
用于泵药的电渗泵的例子公开在美国专利No 6,406,605，3,923,426和PCT公报WO 02/094440中。电渗泵主要包括一个被要被泵的液体弄湿的泵媒介物，和一对电极，电极把电压加在流动方向中的泵媒介物上。通常，泵媒介物是多孔薄膜的形式，当被要被泵的液体弄湿的时候呈现净电表面电荷。电场建立在电极之间，引起泵媒介物的表面附近的液体中的带电物质的移动。这种带电物质的运送沿着将被泵的液体拖拉并在电场方向中产生需要的液体流。每种公开的泵可以用于直接地或间接地泵药物。在直接泵药情况下，药物流过泵媒介物，在间接泵药的情况下，一个第二液体通过泵媒介物被泵出，这个第二液体的移动被用于对要输送的药物加压和驱动。
泵4可以进一步包括声音的，视觉的和/或振动报警器/提醒器66，使用户警觉报警状态，例如，在贮液器中正保留的药物是低量的时候，血液的化学测量是在允许范围以外的情况，低的电池功率，输注管出现堵塞的情况，泵失灵的情况，提醒用户一个事件或执行必要的行动，例如，执行血液化学特性评估，执行药物输送规约，等等，或某些其它用户可确定的警报。和泵4一起使用的合用的警报器/提醒器66可以包括声音装置，例如压电呼叫机，运动装置，例如振动马达；和/或视觉装置，例如，LED，等等。
泵4还包括一个显示器14，例如液晶显示器(LCD)，用于图和字母数字显示。图的显示可以包括一些图符，它代表，例如，食团和基本速度输送状态和调整，关于血液葡萄糖水平的历史数据，存储在存储器中的胰岛素的输送，停止食团指令，等等。选择一个图符将提出相应的用户接口菜单。
泵4还包括一个泵控制器54，它具有一个微处理机，用于控制泵的操作和泵的通信功能。泵控制器54还可能具有一个用于存储泵操作软件程序和其它静数据的存储单元，这些静数据有，例如，预编程序缺省值，它包括但不限于，血液化学特性仪标定信息，用户的偏爱，例如，语言，用户基本定量，碳水化合物和血液葡萄糖食团较正因素，用户目标血液葡萄糖水平，计算器，等等。
存储装置56用于暂时存储动态数据，例如泵输注数据，血液化学特性数据(表链6的仪器/传感器80获得的)和其它用户记入的数据。泵输注数据可以包括的信息，例如药物输送速度(单位/小时)，在贮液器中容有的当时的药物量，食团输送开始/停止时间，食团输送持续时间，等等。血液化学特性数据包括血液葡萄糖浓度(mg/dl)的一些测量和它们各自的日期和时间。用户通过键12记入的其它数据包括但不限于，碳水化合物摄取量(mmol/L)和有关食团输送的参数，例如，食团剂量，食团持续时间，食团开始和停止时间，等等。
泵4还包括控制键12a，12b，和12c，用于使用户记入或选择数据或显示器14上显示菜单的参数。例如，控制键12a可能具有一个凸轮(jogwheel)形状，如图1A所示。特别是，凸轮12a由用户转动以选择所希望的，用泵4输送的药物食团的量。凸轮12a也可被用于通过显示器14上的菜单项目卷动，和通过压下凸轮12a选择这些菜单项目。控制键12b和12c是可压低的按钮，用于启动从表链来和去到表链的数据通信，或其它辅助设备，并用于启动食团输送。泵4可以有任意数目的键，每一个具有合适的形状，例如，凸轮(jogwheel)，可按压按钮，键垫等等，用于控制泵4。
指令和数据是通过单向和双向数据线或总线72和74进入泵控制器54和从泵控制器54出来的。更具体的是，泵控制器54接收来自电源62和电池64的电力，通过控制键12接收来自用户的输入数据和指令，并在单向线路72上传送指令到报警/提醒器66；另一方面，在泵控制器54和泵4的各个部件之间的通信是由双向线路74完成的。泵4和表链6和其它外部设备之间的信息传送将在下面详细描述。
泵遥控/血液化学特性仪(“表链”)
图6是一个短暂血液特性测量传感器和泵4的遥控装置。表链6具有一个外壳20，它最好明和耐用的塑料材料制成，它具有一个小的尺寸，一个工效学的形状，以便在人的衣服里例如口袋，单独携带，或人手持。一般，表链的尺寸不大于泵4的尺寸的1/3。表链外壳20的长度LF在1.5到4英寸的范围内，一般是2到2.5英寸，宽WF在0.75到2英寸的范围内，一般是1到1.5英寸，厚TF在0.25到1英寸的范围内，一般是0.5到0.75。虽然图示中表链实际是一个长椭园形或椭园形，它可以有任何形状，例如是园形等等，最好是一个工效形状。表链6还可以这样构成，例如在它的近端28上提供与附件环22连接，它可以被用于使表链6固定到衣服的一件东西上或钥匙上等等。
在表链’s的远端30上有一个试验片条端口32，用于接收试验片条40，例如一个电化学的，色度的或光度的，在分析物浓度确定中使用的试验片条，例如是，在用户血液抽样中的葡萄糖浓度。安排在表链6中的是仪器80，它用于上述这种确定。试验片条端口32和仪器80也可用于接收标定器80的标定片条等。
适合于和主题发明一起使用的电化学试验片条的例子包括在待审US.申请中所描述的那些，这些待审U.S申请的序号是，09/497,269；09/736,788，和09/746,116，U.S专利6,475,372；6,193,873；5,708,247；5,951,836；6,241,862；6,284,125；和6,444,115，和国际专利申请公报WO/0167099；WO/0173124；WO/0173109；和WO/0206806，它们的公开被这里参考引用。适合于和主题发明一起使用的色度或光度试验片条的例子包括在下述美国专利中描述的那些，这些美国专利是，5,563,042；5,753,452；和5,789,255，这里引入作为参考。适合于和主题系统一起使用的电化学仪的功能性的某些方面被公开在美国专利U.S.6,193,873，以及待审的，共同拥有的美国申请中，其序号是，09/497,304，09/497,269，09/736,788，09/746,116和09/923，093，它们在这里被引入作为参考。适合于和本发明一起使用的色度/光度仪的功能性的某些方面公开在下述美国专利中，U.S专利号是，4,734,360；4,900,666；4,935,346；5,059,394；5,304,468；5,306,623；5,418,142；5,426,032；5,515,170；5,526,120；5,563,042；5,620,863；5,753,429；5,773,452；5,780,304；5,789,255；5,843,691；5,846,486；5,968,836和5,972,294，它们在这里被引入作为参考。
除了包括试验片条仪80，表链6还包括使用户能够遥控注液泵4的部件。这些部件包括一个表链控制器82，它类似于一个泵控制器54，它包括一个微处理机，用于控制泵和传感器/仪器操作功能，并把泵的操作功能和血液化学特性信息从表链6传送给泵4或其它外部设备。表链控制器82可能有一个存储器单元，用于存储泵和传感器操作的软件程序。
表链6还包括一个存储器装置84，用于存储动态数据，例如血液化学特性数据和用户记入的其它数据。存储器84存储有限的数，约10个，例如，最近的血液化学特性测量和这个测量的对应的日期和时间，用户特殊事件的参数，例如，锻炼时间，碳水化合物的摄取，等等。
控制键24可以具有一个凸轮(jog wheel)和/或下压的按钮，形状类似于泵4的控制键12，它使用户记入或选择显示器26上显示的程序菜单数据，该显示器，例如是一个液晶显示器(LCD)，用于显示图和字母数字信息。一般，凸轮(jog wheel)被用于选择或调用数据或选择要实现的食团输送程序或参数。下压按钮通常用于传送数据，例如，葡萄糖结果，食团输送指令，无声警报指令，终止食团输送指令，到泵4或到其它外部设备。由用户经控制键24记入或选择的数据被送到控制器82，以便实现传感器或泵功能，或者把这些数据存储在存储器装置84中。表链6可以具有任意数目的控制键，每个键具有任意合适的形状，例如，凸轮(jog wheel)，下压按钮，键垫，等等。
用户经控制键24记入的数据包括，但不限于，碳水化合物的摄取(克)，所希望的食团输送程序和与食团输送有关的参数，例如，食团剂量，食团持续时间，食团开始和停止时间，药物的类型，药物的数量，目标葡萄糖范围(上限和下限)，锻炼强度，锻炼时间，健康评语，食物类型，食物数量，HbAlc，血压，和在英国专利GB 02129 20.3中公开的其它数据，以及为了确定和调整适当食团体量的用户操作计算器的预备措施。
指令和数据分别经单向和双向数据线路或总线94和96，往返传送到表链控制器82。特别是，表链控制器82接收电源86和电池88的电力和接收用户经控制键24在单向线路94上发送的输入数据和指令；另一方面，在表链控制器82和表链6的各个部件之间的往返通信是通过双向线路96完成的。在表链6和泵4和其它外部设备之间的信息传送将在下面详细描述。
连续生理液监视装置
图6是本发明的另一个系统，它包括连续生理液监视装置300和遥控装置350。遥控装置或表链350可以类似于上述表链6的结构和功能，它可以选择地包括一个用于生理液的不连续的或短暂分析物试验的生理液测量仪。例如，表链350具有一个试验片条端口352，用于接收试验片条40，如上所述。和表链6一样，表链350具有一个低轮廓外壳358，一个显示器354，控制键356，和相同或类似的内部部件(未示出)。
监视装置300也有一个低轮廓外壳360和一个带条362，它可以被佩带在四肢上，例如手臂上，在图6中装置300是戴在病人的上手臂上，但是也可以戴在前臂或手腕上。监视装置300也可以带有显示器364和类似于上述的显示器和控制键的控制键366。如图7所示，外壳360的下面或皮肤一接触侧368带有一个插入槽382，用于接收盘形的，易置的卡盘380，卡盘包括一个液体采样装置302，它可操作地与装在卡盘中的测量传感器或装置304液体连通。测量传感器304可以具有一个电化学的或光度/色度结构，它有能力，类似于WO 02/49507 A1中所公开的那些仪器那样半连续地或连续地测量葡萄糖，该文件在这里全部被引用。在图7的实施例中测量传感器具有电化学的构形，通过一组在卡盘380园周上的电接触垫对384和对应的在插入槽382中的电接触销386，在传感器和监视器300的电子器件之间建立电联系。
图8是卡盘380的放大透视图。卡盘380是由模制基座392制的，它是盘形，直径是20mm到40mm，一般是35mm，厚0.1mm到3mm，一般是2mm。采样装置302是针状410，一个加压环412形成在基座302的底表面390上。针410用于刺入用户的皮肤，以便抽取生物液。针410的内径是在0.1mm到0.5mm的范围内，一般是0.3mm(25号针)。加压环412的作用是对刺入部位周围的皮肤区稳定和加压，以便实际上容易地抽取ISF进入针410。为了完成这些功能，加压环412的直径一般是5mm到30mm，更一般的是12mm。针410被安排在加压环412的槽(未示出)中的近端。针302最好有一个刺入长度尺寸，使得刺入皮肤的深度，病人感觉的疼痛最小。凹槽的深度决定针410的最大刺入深度。象这样，针410可以相对于加压环412被形成和安排，它仅仅刺入而不通过皮肤的真皮层，在这里实际存在着血液自由间隙流体(ISF)，一般是刺入皮肤表面下1.5mm到3.0mm的深度。
最好是，针410和加压环412移动并彼此独立地应用于皮肤。在实际中，一个驱动装置，例如是一个弹簧，被用于推动压力环412抵住皮肤，一个第二驱动装置，例如是一个第二弹簧，用于把针410射入皮肤。虽然这种机械在这里没有专门论述，本领域的普通技术的人是了解这种机械的。
针410安排在与卡盘380中的至少一个或多个传感器或检测器液体相通，以便执行装置300的分析物测量功能。和监视装置300一起使用的合适的卡盘等，被公开在共同拥有的，指定的国际公布的WO 02/49507中，在这里它被全部引用。
图9是图6的系统的功能的原理说明。如图9所示，该系统一般包括监视装置300和遥控表链350。监视器300包括一个易置卡盘380，它与控制器306电连接。卡盘380，如上所述，包括一个采样装置302，与传感器304相连液体通。采样装置302有一个液体取得装置，例如是一个针，它安排在设备外壳外面，用于抽取生理液，例如是来自身体的ISF。在操作中，在皮肤中取得的液体被传送450到采样装置302的液体收集区。该采样液体然后被输送到传感器304中，在这里选择分析物被测量。代表测量值的信号被输入454到控制器306，控制器通过输出信号456(见图10)控制液体抽样测量操作。然后，这些值的表达被显示在显示器364上供使用者观察。然后这个数据通过双向通信信号325被传送到遥控表链350上，在下面将更详细描述。如上所述，表链350还可能具有一个传感器机械，以便测量来自抽样液体458，一般是血液的分析物浓度，抽样液体加到试验片条，插入460到表链350供传感器机械试验。表链350的遥控传感器可被用于校准监视器300的本地传感器。
图10进一步解释监视器300的内部组成部分。如上所述，控制器306具有一个微处理器，用于控制液体抽样测量操作，和装置300的各部分之间的通信，也用于按双向通讯协议325，控制监视器300和表链350之间的通讯。控制器306还可能具有一个存储单元，用于存储传感器操作软件程序和其它静态数据，例如预编程序缺省值，它包括但不限于传感器标定信息，报警，和单位识别/序号。
测量装置300还可能包括声音，视觉和/或振动报警/提醒装置308，用于使用户警觉报警状况，例如，血液葡萄糖水平落在充许值的外面，电池功率降低，液体抽样或传感器失灵，或者用于提醒用户一个事件或执行一个必要的行动，例如替换采样装置。适用的报警/提醒装置308可能包括声音装置，例如一个压电呼叫器；运动装置，例如是一个振动马达；和/或视觉装置，例如一个LED，等等。
测量装置300还包括一个显示器364，例如是液晶显示器(LCD)，用于数据的图象和字母数字显示，例如是抽样液体试验结果，如血液葡萄糖水平，和标定结果。存储器312用于暂时存储动态数据，例如通过传感器装置304获得的血液化学特性数据和用户记入的数据。血液化学特性数据包括各种血液葡萄糖浓度(mg/dL)测量和它们各自的日期和时间。其它可存储在存储器312中的数据的类型包括但不限于下列类型，药物，药物的数量，目标葡萄糖范围(上限和下限)，锻炼强度，锻炼持续时间，健康评语，食物类型，食物数量，HbAlc，血压，等等。此外，电源314和电池316提供必要的电功率以操作测量装置300的各个组成部分。
测量装置300还包括控制键366，使用户记入或选择显示器364显示的菜单的数据或参数，例如，接通和关断设备的信息，暂时中止操作的信息，关断RF发送(在受限制的区域内)，报警确认和复位，与其它设备同步通讯的信息。和泵4和表链6的控制键一样，控制键366可以具有任何数目的控制键，每个键具有任意的合适的形状，例如凸轮下压按钮，键垫等等，用于控制测量装置300。
指令和数据分别通过单向和双向线路或总线320和322，被往、返传送到控制器306。特别是，控制器306接收电源314和电池316的电功率，通过控制键318接收用户的输入数据和指令，在单向线路320上传送指令到报警/提醒装置308；另一方面，在控制器306和测量设备300的各组成部分之间的往返通讯是通过双向线路322完成的。在测量装置300和表链350和其它外部设备之间的信息通讯，在下文中更详细地描述。
如图10所示，本发明的系统可以包括注液泵4和连续生理液监视装置300，其中泵4和设备300之间的双向通讯也被提供。虽然注液泵4和测量装置300是作为分开的部分进行描述，药物输送和生理液抽象和测量元件和功能可以被结合成一个整一的装置，从而共同具有电源，控制器，报警器，显示器，存储器，通讯部分。这样一个整一的单元的优点是，病人只需携带或佩带一件硬件而不是两件。
通信和数据传输
双向通信(图2中参考标号15，图9和10中参考标号325，图10中参考标号340所标示的)和在泵4和表链6之间，在测量装置300和表链350之间的数据传送，可以通过任何合适的装置，例如无线电频率(RF)传输，红外线(IR)传输，等实现。例如，泵4和表链6每一个可以具有一个RF通信模块68和92，它们分别由各自的控制器控制，使得在所提供的两个设备和这些设备之间的双向通信是在其相互最大的范围之内。一般，这个范围是在0到10ft的范围内，更一般的是在0到4ft的范围内，通常不大于25feet。类似地，测量装置300可能具有RF通信模块324，它由控制器306控制，控制器306提供了在测量装置300和表链350之间的双向通信。此外，泵4和测量装置300可以以同样的双向方式或通过一个表链，彼此直接通信。在注液泵和测量装置整体化为一个单一单元的系统中，通信是由共同的控制器或微处理器管理。
模块68、92和324被编程序以便把特定的泵单元和/或测量装置“链接”到一个特定的表链单元，防止在相同频率范围内，在表链和其它注液泵和测量装置之间出现无故通信。在泵—表链或测量装置—表链，或泵/测量装置—表链组合之间建立通讯协议，以便提供与先于两个之间的每个数据传输的一对有关的地址，以防止在一个用户系统和另一个用户系统之间出现无故传输。模块可能进一步链接一个表链到多于一个的泵和/或属于相同用户的测量装置，因为某些用户具有多于一个的泵。同样，模块可以被编程序去链接一个泵和/或测量装置到属于同一用户的多于一个的表链上。
虽然在泵4和表链6之间传输的大多数数据和信息是由用户开始的，但在两个设备之间也存在某些通讯，它们是自动的，不需要用户干予的。例如，模块可以这样形成，使血液化学特性数据和用户偏爱信息，例如语言，食团限制等等，周期性地从表链发送到泵，或从泵发送到表链，或在接通表链的情况下自动发送。同时，模块也可以这样形成，使药物输注信息，例如，历史基本定量和食团输送数据，周期性地从泵发送到表链。
类似地，关于病人的血液葡萄糖水平的信息，如测量装置300所监视的那样，可以自动地连续地或周期性地被传送给表链350。特别在警报装置没有被提供的测量装置300的那些实施例中，表链可以具有警报器，使病人警觉，病人的血液葡萄糖水平落入充许范围之外，这个充许范围可以是用户或医生规定的。系统可以被编程序以便自动调节，处理胰岛素输送规约或通过进入表链350的输入信息提示病人放弃规约。
系统还可以这样形成，使得泵4和测量装置300能够彼此通信。在泵4和测量装置300是分开的组成部分的地方，它们可以通过类似于泵和表链互相通讯的方式的，双向通讯340的装置进行通讯。在整一设备中，药物输送泵和液体抽样和测量装置的功能是由一个公共控制器(未示出)控制的。在任一情况下，系统可以被编程，使得泵4执行的药物协议，根据测量装置300确定的分析物测量水平，通过表链6的往返指令，自动进行调整。这个工作可以被完成而无需病人的任何干予，甚至没有通知病人或病人没有意识到规约的调整。
泵4，表链6或350，和测量装置300分别可选择地包括通信模块和/或输入/输出端口70，90和326，(例如一个RS232(IEEE标准)或通用串行总线(USB))，以便和外部设备，例如个人计算机(PC)，个人数字助理(PDA)等进行通信。在本发明的实施例中，通信模块可以采用无线通讯方法，例如Bluetooth或一个Wi-Fi 802.11方案。例如，存储在泵，表链，或测量装置控制器和存储器装置的任一个或每个中的数据可以被下载到一个外部计算机，供医生详细检查，分析或进一步处理，以便确定，例如，药物方法的有效性，病人的配合或病人葡萄糖水平的趋向。相反，医生可以使用外部计算机下载软件程序和操作参数，例如，病人的基本量和某些定制的目标值，范围，提示和警报，到泵和/或表链控制器。本发明的装置和外部装置之间的通信可以通过遥测器传送提供，例如是，RF，IR，等，或数据端口技术，例如，调制解调器，电缆，等等。
在本发明的实施例中，表链6还结合了存储器84的一部分，使得进一步更新(“程序升顷”)操作系统和/或其它软件单元。最好是，存储器84的一部分，是“闪存”(“flash memory“)型的，它不需要电能，以便可靠地存储它的内容。
表链6还可能包括一个通信狭孔(未示出)，以便接收数据运载单元和与其通信。这个数据运载单元最好是一个“SIM”卡型装置。一个单一应用的数据运载单元是由或在每个易置卡盘上提供的，它包括许多特殊数据的生产(标定数据，识别数字等等)。数据运载单元由遥控器读出，由此接收的数据被用于整理分析从表链6收到的ISF葡萄糖数据。
软件算法
主题系统的每一个组成部分具有软件，它使得各组成部分执行不同的功能和使它们彼此通信。本发明使用的软件的某些特点和算法在下面详细描述。
主题系统优于许多传统的胰岛素输送系统的优点在于，它把血液化学特性仪和胰岛素泵的遥控零部件结合在一个很小的，独立的设备，例如上述的表链之中。除了遥控胰岛素泵和测量装置而外，表链还使在一段时期的血液化学特性数据和胰岛素输送数据结合起来，并保持这个结合数据供用户或医生立即和以后取回。这样，所有关键信息和影响病人治疗的事件的综合分析就可以做出。
这个优点是由主题系统的某些特点提供的，它使得用户在监视和控制血液葡萄糖水平中具有广泛的灵活性。特别是，主题系统使用户有能力在任何时间上改变食团和基本定量输送缺省参数。软件算法提供了更多的这种灵活性，以便控制和调整药物食团。
泵4的控制器54和表链6的控制器82用软件编程序，支持几种食团输送规约的类型：标准型，展开型和双重型。标准或“快速”食团输送规约使用户选择药物剂量以便整个食团立即输注。用户可能要求的刚刚进餐或快餐以前的快速食团输送，它包括简单的碳水化合物，例如水果等等。展开食团输送规约使用户在某个时间范围内的一段选择时间上，选择输注的药物剂量。展开食团输送规约一般在进餐以前实行，它包括复杂碳水化合物的相当大的部分，例如淀粉，等等。双重食团输送规约联合上述两种规约，使用户按单一指令程序连续地实行快速食团和展开食团。双食团输送协议一般先于进食实行，食物包括简单的和复杂的碳水化合物两者。
为了更好地处理用户立即的和发展中的需要，本发明通过计入或补偿用户当前的或实际当前的血液化学特性评估和/或用户的预期的和/或实际的碳水化合物摄入量而使用户定制一个胰岛素食团输送规约。特别是本发明提供了三种计算器功能选择，即碳水化合物计算器功能，血液葡萄糖计算器功能和联合计算器功能，它使用户选择血液化学特性和碳水化合物摄取的任何一个或两个，以及更多的次要因素，例如，先于实行食团输送规约，用户所进行的锻炼。虽然所有三种食团输送算法可提供所有三种计算器功能选择，但是，一般对于展开食团输送(或独立或与快速食团输送结合)计入血液化学特性数据是不合适的，因为血液化学特性在较短的时间期间以后可能变化，即先于展开食团输送的完成。
图3A，3B和3C分别是本发明三种食团输送算法的方块图，图4A，4B和4C分别是本发明的计算器功能选择的方块图。在本发明的进一步的描述中，三种输送算法的每一种首先在没有计算器功能选择的情况下被描述，当其应用于标准和展开输送算法的时候，三种计算器功能的描述跟在其后。虽然这些算法可以通过用户与泵或表链的任何一个接口来实现，下面的描述是用户与表链接口的情况，即最可能的情况。
                    A、食团输送算法
                    1、标准食团输送算法
如图3A的方块图所示，在从表链显示的食团功能菜单(见图5的246步)选择标准胰岛素食团输送程序100的时候，用户被请求调整他或她希望配给的标准食团剂量(SDOS)102。为了防止过剂量，如果进入的单位少于最大数量(SMAXU)104，算法将只实行食团输送，SMAXU将取决于个别用户身体的体重和新陈代谢而变化。对于具有平均体重和新陈代谢的用户，SMAXU约是10个单位。不过，SMAXU对于儿童可能低，对于肥胖者可能高。SMAXU在主题系统的开始程序中可作为缺省值被调整，或在特定标准食团的程序中由用户改变。步骤102和104总括成为126，用于描述图3C的步骤，如下所述。一旦食团的剂量被调整到合适的限度以内，用户就被提示开始定制的食团输送106。在开始这个SDOS输送的时候，全部SDOS被立即输送给用户，步骤108。
                   2、展开食团输送算法
如图3B的方块图所示，在从表链显示的食团功能菜单(见图5步骤246)选择展开食团输送程序110时，用户被请求调整，他或她希望输送的展开胰岛素食团剂量(EDOS)(单位)，步骤112。为了防止过剂量，如果进入的EDOS值小于最大最(EMAXU)114，算法将仅执行食团输送，如上所述，它取决于个别用户的体重和新陈代谢而变化。然后，用户被提示记入所希望的展开食团输送(DTIM)116的持续时间，它的时间期范围是从最小时间(MINT)到最大时间(MAXT)。这样的DTIME的范围是从1分钟到24小时，但是更一般的范围是从30分钟到8小时。如果进来的DTIME的值是在充许范围118的外面，用户就被提醒再记入一个充许值。步骤110，112，114，116和118合并成为128，目的是描述图3C的步骤，如下所述。一旦两个参数被调整在充许的限度内，用户就被提醒开始所定制的展开食团输送120。在开始这个EDOS输送的情况下，在DTIME 122上，EDOS被输送给用户。
                   3、双重食团输送算法
如图3C的方块图所示，在从表链显示的食团功能菜单(见图5的步骤246)中选择双重食团输送程序的时候，和在图3A中标准食团输送算法126中一样，用户被请求调整他或她所希望输送的标准食团剂量(SDOS)(单位)，它具有小于最大量(SMAXU)的值，如上所述。然后，和图3B的128所示的展开食团输送算法中一样，用户被请求再次调整，他或她所希望输送的展开胰岛素食团剂量(EDOS)(单位)，它具有小于最大值(EMAXU)的值。此外，用户被提示记入在充许时间范围内的所希望的展开食团输送(DTIME)128的持续时间，如关于图3B所述。一旦这两个参数被调整到充许范围之内，用户被提示开始SDOS和EDOS130两者的输送。在开始这样的SDOS和EDOS输送的时候，完整的SDOS立即被输送132到用户，在SDOS输送134完成的时候，EDOS输送开始136，并在DTIME138上被连续输送给用户。
                    B、计数器方式
                1、碳水化合物计数器方式
参考图4A，在选择碳水化合物计算器方式(CARB、CALC)140的时候，用户首先被提示记入他或他打算马上消耗的碳水化合物(CARB)的预期或实际的克数。一般表链被编程序以接收不大于约200g的一个预选最大碳水化合物值(MAXG)，即一个具有平均体重和新陈代谢的成年人用户的一般MAXG值，但是可以按用户的体重和新陈代谢的不同而变化。如果记入的CARB值大于MAXG144，用户被提示再记入一个可接受的CARB值。
根据在这点上用户可以改变的，预编程序食团剂量与碳水化合物的比(B/CRATIO)(单位/克)(Units/g)，表链控制器82确定要输送的胰岛素的剂量(XDOS)(单位)146，其中XDOS可能是SDOS或EDOS。B/CRATIO一般是在1单位：30g到1单位：50g的范围之中，但是取决于用户的条件和需要它可以更多或更少。XDOS的值是CARB的值和B/C RAT10的值的乘积(CARB×B/CRATIO)。
在B/C RAT10被设定以后，用户被提示记入碳水化合物校正因素(CARBCF)(单位)148，以便调整XDOS，即减少或增加XDOS，以便精细地调整食团量，例如，当进餐以后不久用户预期锻炼的时候。CARB CF值必须在最小值MIN CF)到最大值(MAX CF)的范围内。对于一般用户，CARB CF值一般在0单位到10个单位的范围内，但是根据用户的需要可以多些或少些。如果所记入的CARB CF值是在允许范围150之外，用户被提示再输入一个充许的CARB CF值。
一旦所有参数被设定在合适的限度内，表链就提示用户启动XDOS输送，并且，反过来，用户起动表链传送一个XDOS输送指令152到泵。泵然后起动XDOS输送到用户154。
                 2、血液葡萄糖计算器方式
参考图4B，在选择血液葡萄糖计算器方式(BG CALC)160的时候，表链提示用户记入他的或她的由表链的仪器80测得的最近的血液葡萄糖浓度水平(ACTUAL BG)(mg/dL)162，或者如果它产生在规定期限以内，最近的血液葡萄糖试验的血液葡萄糖浓度水平可以被自动记入。可选择的是，ACTUALBG可以用生理液测量装置300测量并直接传送到表链6，如果仪器80被单独使用的话，它使得BGCALC在高频率上被利用。ACTUAL BG值必须是从最小值(MIN ABG)到最大值(MAX ABG)的范围之中。对于一般用户，ACTUAL BG的值一般是在0mg/dL到600mg/dL的范围之间，但是可依据用户的需要更多或更少。如果记入值是在这个范围164以外，用户被提示再记入一个可接受的ACTUAL BG值。
然后表链控制器82确定要被输送的胰岛素(SDOS)(单位)(Units)的标准食团剂量166，它的值是食团与血液葡萄糖的比(B/GB RATIO)(Units/point，这里一个点(point)等于1mg/dL)和ACTUALBG的值与用户的目标血液葡萄糖水平(TARGET BG)(mg/dL)之间的差的乘积，用下列等式表示：B/BG RATIO X(ACTUAL BG-TARGET BG)。B/BG RATIO是预编程序值，它的值，在这点上，可以在预定范围内被用户从最小值改变。对于一般用户，B/BG RAT10的变化范围是从1单位：150Pt到1单位：10pt，但是可依据用户的需要或更多或更少。TARGET BG也是一个预编程序值，它的值也可以由用户在预定范围内改变。对于一般用户，TARGET BG可以是60到250mg/dL，但是可以依据用户需要更多或更少。
其次，表链提示用户记入血液葡萄糖校正因素(BG CF)(单位)174以便调节SDOS，即，减少或增加SDOS以便精确调整食团量，例如，当在餐后不久用户期望锻炼的时候。BGCF的值必须在最小值(MIN BGCF)到最大值(MAXBGCF)的范围以内。对于一般用户，GB CF一般是从O单位到10单位，但是可以取决于用户的需要更多或更少。如果记入的BG CF的值是在充许范围176的外边，用户被提示再记入一个可接受的BG CF值。
一旦所有的参数已被设定在合适的限度内，表链提示用户开始SDOS输送，然后，用户起动表链，发送一个SDOS输送指令到泵178。泵然后起动SDOS输送到用户180。
                     3、联合计数器方式
现在参考图4C，在选择联合碳水化合物/血液葡萄糖计数器方式(CBGCALC)190的时候，要求用户记入他或她预期吃进的碳水化合物的量，在图4A的集合步骤192上，表链根据这个CARB值和预编程序的B/C RATIO确定XDOS。然后，在图4B的集合步骤194上，用户记入他或她的ACTUAL BG，并根据ACTUAL BG和用户的B/BG RATIO和TARGET BG的预编程序值表链确定要被输送的SDOS值。在本发明的另一实施例中，用户的ACTUAL BG被自动发送到表链，然后表链根据ACTUAL BG，根据用户的B/BG RATIO和TARGET BG，确定要被输送的SDOS。
然后，如果必要的话，表链提示用户选择一个校正因数(COMBO CF)(U单位)196去调整XDOS，即，减少或增加XDOS，以便精确调节食团量，例如，当在进餐以后不久用户期望锻炼的时候。COMBO CF值必须在从最小值(MIN COMBO CF)到最大值(MAX COMBO CF)198的范围内。对于一般用户，COMBO CF一般从0单位到10单位，但是可以依据用户的需要更多或更少。如果所记入的COMBO CF值是在可接受的范围的外面，用户被提示再记入一个可接受的COMBO CF值。
一旦所有参数已被调整在合适的限度内，表链提示用户开始XDOS输送，依次，用户起动表链发送一个XDOS输送指令到泵200。泵然后开始XDOS输送到用户202。
方法
综上所述，本发明提供了遥控病人药物输注的方法。本发明的某些方法现在参考图5进行描述。在一般由用户的医生执行的，主题系统的泵和表链的开始程序以后，表链将保持在睡眠方式220直到用户起动222。在这个开始阶段，表链，通过信息链路，要求泵给表链提供泵的状态信息，例如，正在进行中的食团的状态，进行中的基本量，保留的胰岛素，等等，算法结构信息，例如，缺省值，它包括但不限于，B/C RATIO，B/BG RATIO，TRAGET BG，食团限度，食团步骤，程序结构，即，所选择的展开或双重食团功能，所选择的碳水化合物或血液葡萄糖计算器方式。在接收这个请求的阶段，泵发送请求状态和结构信息到表链224，它然后被表链接收226。
如果这个信息表示食团输送是在进行之中228，表链将显示“食团在进行中”菜单230，并询问用户他或她是否想要停止食团输送232。如果用户表示他或她希望停止食团输送，表链发送一个STOP BOLUS指令到泵234。在收到这个指令以后，泵停止食团输送并发送修改的泵状态信息到表链236。表链显示这个状态信息给用户238，在短时间以后，返回睡眠状态240。
另一方面，如果用户不想停止进行中的食团242，或者目前没有食团在进行之中244，表链显示泵状态信息和“食团功能”菜单246。然后用户选择所希望的食团程序，例如，标准食团程序，展开食团程序或双重食团程序，表链发送食团输送程序起始指令到泵248。根据这个指令，泵使食团输送计时复位，并发送一个肯定符号到表链250。表链然后询问用户关于具体食团程序数据252，有或没有使用计算器功能，例如，碳水化合物计算器方式，血液葡萄糖计算器方式或联合方式，这一切包括记入或选择所选择的算法所要求的所有必要信息，如图3A-3C和4A-4C中所示。
在完成食团输送规约的程序以后，用户起动表链发送食团值和DELIVER食团指令给泵254。如果食团输送在食团输送计时期满以前开始256，则泵起动食团输送，取消计时器并发送一个肯定符号到表链258。在一段短时间以后，表链返回睡眠状态260。
另一方面，如果计时器在食团输送开始以前期满262，泵起动报警264，或者声音，振动和/或视觉的警报，如上所述，显示给用户，泵有故障。泵同时起动报警，以便使用户注意到预编程序提醒器，例如，进行血液葡萄糖测量的提醒器，等等。在报警提醒以后，用户开始启动睡眠的(如果是睡眠的)表链，然后表链请求泵提供给表链警戒/报警/提醒状态266。泵，依次，发送这些信息给表链268。表链然后显示当前正在进行中的警戒/报警/提醒，根据它们用户起动表链发送CANCEL ALARM指令到泵270，并处理报警的原因，例如清除泵输注管的阻塞，或执行必要的任务，进行血液葡萄糖测量。随后，泵取消了报警和食团输送计时272。在一段短时间以后，表链返回到睡眠状态274。
成套部件
主题发明还提供了一些成套部件，它们用于实践主题方法。主题发明的一个实施例的一些成套部件包括至少一个主题注液泵和至少一个主题表链，如上所述。成套部件可以包括一个或多个泵输注装置和/或一个或多个适于和表链仪器一起使用的试验片条。在主题发明的另一个实施例中，成套部件包括至少一个测量装置和至少一个表链。另一些成套部件包括至少一个注液泵，至少一个测量装置和至少一个表链。成套部件还可能包括记录在CD-ROM等上的软件程序，它的程序可以通过外部设备，例如是一台计算机，由用户或医生下载到泵和/或表链。最后，成套装置还进一步包括使用主题设备的说明。这些说明可以提供在成套部件中的一个或多个包装件，标签插入件或容器上，或提供在CD-ROM等中。
由上述描述和讨论可以明白，上述发明提供了一个对病人执行药物规约的简单，方便和单独的方法。本发明最小化了病人他或她必须携带的装置的数量，以便有效地分配药物和监视它在病人身上的效果。本发明对病人他或她的药物配给具有最大实时控制的灵活性。因此，本发明对本技术领域起了重大促进作用。
本说明书中引用的所有公报和专利这里被引入作为参考，正如个别的公报或专利被专门地，单独地引用一样。任何公报的引入是在申请日期以前的公开，不应理解为承认本发明因在先发明而不享有比上述在前公开之前要早的权利。
虽然为了清楚理解的目的，上述发明用图解和举例的方法作了详细描述，本发明的内容对那些熟悉技术的普通技术人员是显而易见的，某些变化和修改可以做出而不脱离所附权利要求书的精神和范围。

Claims (11)

1、一种系统，包括：
一个可以佩带在病人身体上的药物注液泵；
一个可以佩带在病人身体上的生理液监视装置，它实际地，连续地监视生理液的至少一个特征；
一个遥控装置，用于遥控药物注液泵和生理液监视装置，其中遥控装置包括一个生理液监视装置，用于短暂监视至少一个生理液的特征。
2、权利要求1的系统，包括在遥控装置，药物注液泵和生理液监视装置之间进行通信的装置。
3、权利要求1的系统，其特征在于，所述遥控装置包括：一个通信模块，用于与药物注液泵进行通信和用于与生理液监视装置进行通信；
一个或多个控制键，用于用户与遥控装置进行接口；和
一个控制器，用于控制往返通信模块的数据的传送和接收，并用于处理用户接口数据。
4、权利要求1的系统，其特征在于，所述遥控装置还包括一个端口，用于可操作地接收生理液试验片条。
5、权利要求1的系统，其特征在于，所述药物注液泵还包括：
一个通信模块，用于与遥控装置进行通信；
一个或多个控制键，用于用户与药物注液泵接口；和
一个控制器，用于控制往返遥控装置的数据的传送和接收，并用于处理用户接口数据。
6、权利要求1的系统，其特征在于，所述生理液监视装置包括：
一个生理液采样装置；
一个传感器，用于测量生理液中一个或多个分析物的浓度，其中所述传感器可操作地与上述生理液采样装置液体连通。
7、权利要求6的系统，其特征在于，所述生理液监视装置还包括：
一个通信模块，用于与遥控装置进行通信；
一个或多个控制键，用于用户与药物注液泵接口；和
一个控制器，用于控制往返遥控装置的数据的传送和接收，并用于处理用户接口数据。
8、一种分配药物的系统，包括：
一个可以佩带在病人身体上的药物注液泵；
一个遥控装置用于遥控药物注液泵；和
一个处理器，与上述遥控装置结合在一起；
与上述处理器一起使用的软件通过上述药物注液泵实现药物输送规约，所述药物输送规约包括，第一药物输送规约，用于立即输注所选择的药物剂量，第二药物输送规约，用于输注在所选择的时间段上所选择的药物剂量，和第三药物输送规约，用于在所选择的时间期间内立即输注第一选择药物剂量，随后输注第二选择药物剂量。
9、权利要求8的系统，其特征在于，所述软件包括算法，用于计算病人当前或实际当前的血液葡萄糖水平或病人预期的或实际的碳水化合物摄取，并用于根据所述血液葡萄糖水平或所述碳水化合物摄取量修改所述药物输送规约。
10、一种监视和控制病人的生理液分析物的浓度的方法，包括：
短暂测量病人的生理液抽样的分析物的浓度，其中短暂测量是用遥控装置进行的。
使用经皮装置对病人的生理液进行实际的连续地抽样。
实际地连续地测量抽样生理液中的分析物的浓度；
传送代表分析物浓度的数据到遥控装置；
确定是否分析物浓度落在充许范围的外面；和
根据分析物浓度落在充许范围的外面的确定调整药物输送规程。
11、一种监视和控制病人葡萄糖水平的方法，包括：
短暂测量病人的生理液抽样的葡萄糖浓度；
提供表示病人碳水化合物摄取量的值；
根据所述葡萄糖浓度和所述碳水化合物摄取值计算配给病人的胰岛素的剂量；
发送代表所述剂量的无线电频率信号到病人佩带的胰岛素注液泵，所述注液泵包括一个无线电频率接收机，用于接收所述无线电频率信号；和
通过所述注液泵，分配所述剂量的胰岛素给病人。
CN03110722A 2002-02-26 2003-02-25 遥控药物输注和分析物监视的系统和方法 Pending CN1449840A (zh)

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