CN1128353A - 用于监测患者血液中待分析物质的分析系统 - Google Patents

用于监测患者血液中待分析物质的分析系统 Download PDF

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CN1128353A
CN1128353A CN95105402A CN95105402A CN1128353A CN 1128353 A CN1128353 A CN 1128353A CN 95105402 A CN95105402 A CN 95105402A CN 95105402 A CN95105402 A CN 95105402A CN 1128353 A CN1128353 A CN 1128353A
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D·布克
H·-P·哈尔
P·布拉斯堡
R·科图拉
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Abstract

用于监测患者血液中待分析物质浓度的分析系统，包括含有试剂的分析元件(12)和评价仪器，评价仪器含有测量装置，该测量装置用于测量因被分析物质和试剂相互反应时发生的变化，由此根据如此获得的测量值来确定代表元件分析数据CA的分析数据。

Description

用于监测患者血液中待分析物质的分析系统
本发明涉及一种用于监测存在于患者血液中的待分析物质(分析物)的分析系统。
在许多情况下，必须定期地对血液中被分析物的浓度进行监测。在需要根据特殊物质的浓度进行常规药物治疗时尤其是这样。最典型的例子是糖尿病。这种病的患者应该经常地监测他们的血糖指标以便在需要时配合胰岛素注射并由此将血糖指标(即，血液中的葡萄糖浓度)保持在特定的范围内。要避免血糖高于该范围(高血糖)或降至该范围以下(低血糖)，同时尽可能可靠地避免两种临界的严重情况和严重的长期疾病(例如丧失视力)。
尽管本发明还适用于其它需要分析的物质，但是其主要涉及血糖浓度的监测。应该认识到，下文中有关葡萄糖测定的任何讨论均不对本发明的普通应用构成限制。
用于监测血糖浓度的传统分析系统包括固态分析元件也称为测试载体和评价仪器。通常，分析元件和评价仪器相互间特别匹配并由相同的制造商作为一个系统提供。
分析元件包含试剂。当使元件与测试样品相接触时，样品中的被分析物和试剂之间发生反应并在分析元件上产生可进行实际测量的变化，该变化与所说物质的浓度有关。评价仪器包括测量所说变化的测量系统和根据在测量所说变化时得到的测量值对被分析物的浓度进行测定的电子设备。先进的装置采用微机作为评价用的电子设备，它能够进行软件控制的数字处理，由此将测量值转换成与被分析物质的浓度相应的信号。通常，这些分析数据以浓度的单位显示在字母数字显示器上。然而，本发明意义上的用语“分析数据”还包括用其它方式表示分析结果的电信号，例如，对与被分析物质浓度有关的信息显示偏差进行控制的信号，如“理想范围”、“上标准范围”、“上危险区”，等等。
众所周知，从反应原理和与浓度有关的可测量的变化方面来看，不同种类的分析元件涉及不同的物理化学原理。传统的分析系统主要是光度学式的或电化学式的。
就光度学式的分析系统而言，分析元件包括试剂系统。试剂与被分析物的反应产生光度学上可探测的变化(颜色变化)。通常，将试剂置于多孔塑料或纸模上以形成分析元件的测试区，所说纸模的颜色随浓度而变化。该颜色变化可用反射光度计定量测定。
电化学式分析元件包括电化学试剂系统。该试剂与被分析物的反应影响分析元件两端的电势和/或当所说两端的电压不变时影响分析元件两端的电流。因此，在这种情况下，实际上可测得的变量是电压或电流而且该变量是通过与设备相组合的相应电压或电流传感器进行测定的。最好再一次使用微机评价电子器件将所说的与被分析物质浓度有关的测量值的变化转换成分析数据(被分析物质的浓度)。
用包含试剂的分析元件进行操作的分析系统(以下称为“元件分析系统”)具有较高的精度并且极容易操作以致于患者自己可以使用它们对血糖浓度进行经常性的监测(家庭监测)。然而，它们具有明显的缺点，即每次进行特定的分析时，需要抽取血滴然后使血滴与分析元件相接触。通常，这个过程是通过刺破手指来完成的，换句话说，每次分析都会带来有感染危险的痛苦的皮肤伤害。这种方法称为“侵入式分析”。
为了在提高精度和以少量的侵入获取样品的同时连续监测血液中待分析物质的浓度，本发明在前面讨论的那种分析系统的基础上公开了一种系统，该系统包括可以在患者身上移动的传感器单元，传感器单元由无试剂的传感器构成，其可直接地在患者身上测量与被分析物质浓度有关的参数，所说单元进一步包括用于无线传输数据信号的发送器。所说的系统还包括传感器评价电子设备，其用于根据被测的参数的传感器测量值对传感器分析数据进行测定。评价仪器是整个分析元件/传感器监测系统的中央单元，其包括用于接收来自传感器单元的数据信号的无线接收器，此外，还包括根据来自分析元件的分析数据(“元件分析数据”)对传感器分析数据进行校正的校正装置和用于长期储存分析数据的数据存储器。
用于测定血液分析物的无试剂传感器分析系统已在很多实施例中进行了描述。这些系统已足以适用对某些待分析物质进行分析(特别是血氧值和血气浓度)。然而，对一些其它待分析物质而言，特别是葡萄糖，这些系统还不是十分适用。
在J.clin.chem.clin.Biochem.26，1988，第201-8页上由J.D.Kruse-Jareese所著的”PHYSICOCHEMICALDETERMINATION OF GLUCOSE IN VIVO”文中给出了测定葡萄糖的非侵入式测量方法。
为了实现对组织中被分析物质浓度进行分析测定的目的，本发明主要采用了照射光和活体组织(最好是表皮组织)之闻相互作用的系统。假设(血液循环)组织中分析物的浓度实际上与血液中的相应浓度有极大的关系。在这种系统中，传感器单元包括用于照射组织的光发射器。此外还设有光探测器，在光与组织相互作用时，通过光探测器可以检测离开身体部分的光从而确定可测量的物理光特性，该特性随光与组织的相互作用而变化。在该方法中可测量的物理特性构成了与被分析物质浓度有关的参数。
目前已知的大多数这类方法以光谱分析为基础。其中通过确定对光波长的光吸收关系来测定吸收特性(因被分析物质分子的振动和转动状态产生的)。实际上从窄带光发射器发出的是不同波长的普通光并且自光探测器对接收到的光进行测量。此外，照射光也可以来自宽带光发射器并可以在探测侧进行选择性的波长测量。上述所讨论的分子吸收带(特别是葡萄糖)处于远红外光区。然而在该光区内组织水能引起强烈的光吸收，所以，大多数人建议在近红外光区测量波长，由此可以探测分子振动和转动状态的谐波。例如，EP-A0160768，WO93/00856和美国专利5028787已对这种系统进行了描述。
在本发明特别优选的实施例中，使用了一种根据组织的折射率来测定光参数的传感器系统。该方法实际上基于这样一个发现，即可以将组织中与葡萄糖浓度有关的液体折射率的变化作为和葡萄糖浓度相关的参数。
为了实现这一方法，有入建议采用一种测量技术对受通过组织散射中心的多次散射光影响的信号进行测定，该方法已在国际专利申请PCT/DE93/01058中进行了描述。在所述出版物描述的测量条件下，多次散射增强了因折射率变化而产生的效果，所说的这种增强可以通过较强的和因此更容易测得的信号变化得以确定。引用的参考文献包含了更详细的内容，可将它们作为参考内容与本发明公开的内容相结合。
德国专利申请4337570描述了一种以确定与光在组织中的传播时间相应的光参数为基础的葡萄糖分析方法。这种传播时间参数可以正好是超短光脉冲的间隔时间。然而，用测定与组织中的葡萄糖浓度有关的时间传播参数来代替测定光在组织中的相移要简单得多。
最近，同时申请的德国专利申请4415728“METHODAND DEVICEFOR ANALYZING GLUCOSE IN A BIOLOGICSAL SAMPLE”中描述了如何用低相干性干涉测量法确定组织折射率。可以直接通过确定光在组织中的光路进行这种测定或直接用确定组织中光散系数的方式进行这种测定。液体的折射率和组织散射中心(例如细胞)的折射率之间的关系对散射系数起决定性的作用。所说申请的内容在本说明书中引用作为参考文献。
在本发明中将这样一个非侵入式传感器分析系统与一个用以试剂为基础的分析系统操作的侵入式分析系统相结合。传感器分析系统包括一个带在患者身体上的可移动的电池驱动传感器单元和一个评价装置，该评价装置在某种意义上是固定的，它不带在患者身上但处于一个合适的位置上，例如在患者的居室内。然而，中央单元最好是小的和重量轻的，其足以便于患者在离开所说居室一段时间(例如几天)对随身携带。基本单元和中央单元通过无线数据传输方式相连通。所说的连通可以通过多种方式实现，例如使用IR光，高频无线电波或超声波。
装在患者身上的传感器单元和固定的中央单元共同完成传感器分析系统的任务。可以将该系统的任务分配给不同方式的两个单元。通常，可以将传感器单元设计成无自身智能，它的任务仅仅是测定传感器测量值并将其以无线的方式传送至中央单元。然而，最好是将传感器单元设计成带有自身智能，也就是说，它包括一个作为评价装置的微机数据处理系统，其用于根据传感器单元中至少一个传感器的测量值来确定传感器分析数据，所说的测量值对应于被分析物质的浓度。因此，可以在传感器单元上设置它自己的显示器以指示被分析物质的浓度数据，例如当葡萄糖浓度向上或向下超过特定的范围时仅仅发出声响或发光警报。此外，在该实施例中传感器单元和中央单元之间的连通最好是相互的，也就是说，不仅将来自分析元件的分析数据从传感器单元传输到中央单元，而且反过来也一样，可以使数据从中央单元发送到传感器单元。该特征特别适合于对用于确定被分析物质浓度的传感器单元进行校正。
此外，传感器分析系统的中央单元同时作为侵入式元件分析系统的评价仪器并根据元件分析分系统的测试数据对传感器分析分系统进行校正，这一点在本发明中是很重要的。
与过去通常使用的分析元件相比，本发明所说分析系统的一个显著特点是可以连续实时地提供电流分析数据和在任何时间都能获得有关葡萄糖浓度变化率的可靠信息。这对于那些有糖尿病危险，例如在晚间休息时出现高血糖或低血糖趋向的糖尿病患者来说是非常重要的。此外，当增加身体运动量，例如在进行体育运动时对葡萄糖进行参数监测是极其重要的。对于用胰岛素治疗的糖尿病患者来说，提供这样的可能性，即定量地测定葡萄糖值的瞬时趋势(升高或降低)从而确定所需胰岛素的量也是非常重要的。
下面将通过附图中所示的示例性实施例对本发明进行说明。
图1是本发明所述分析系统中各部件的透视图；
图2是方框图；
图3是作为时间函数的分析数据的曲线图，其表示校正过程；
图4是带有第一实施例中图形显示器的中央单元的顶视图；
图5是带有第二实施例中图形显示器的中央单元的顶视图。
图1中所示的完整的分析元件/传感器系统IASS1包括置于患者身体上的传感器单元2和通过用箭头4表示的无线数据传输与传感器单元2连通的中央单元3。在所示的最佳实施例中传感器单元2包括基本单元6和两个通过电缆9与基本单元6相连的传感器7、8。基本单元6可以通过颈圈戴在患者的脖子上。显然也可以用其它的方式固定基本单元，例如用肩圈或带将其固定在患者身上。
原则上可以只用一个传感器进行操作。然而，最好是使用二个或多个传感器以便同时在身体的几个测试部位上测量与葡萄糖浓度有关的参数，由此，通过例如平均测量值或根据预定的安全标准选择较好的测试值可提高精度。
中央单元3具有通常用于元件分析系统中的评价仪器的典型特征。在所示的情况下，其用于评价由带有基层14和测试区15的葡萄糖测试条13构成的分析元件12。为了进行评价，将分析元件12插入位于装置3的挡板18下部的测试通道17中。中央单元3上设有用于操作该单元的按键20。显示器21用于信息输出，特别用于显示分析数据。
用于对与中央单元3中合为一体的分析元件进行评价的评价装置是一种传统设计的装置，因此不需要进行更详细的描述。在许多出版物中都可获得相关的信息。例如，欧洲专利申请0492326中描述了一种普通的仪器设计，而在欧洲专利申请0075767中描述了一种实用的测量电子设备。
图2是中央单元3和传感器单元2的基本功能元件的方框图。
中央单元3包括一个用于测量与被分析物质浓度变化有关的分析元件12的变化的测量装置23，例如一个测量测试区15颜色变化的反射光度计。测量装置23产生与随浓度变化的测量值R相应的电信号。
将测量值R送至作为微机25一部分的评价用电子设备24，微机25还包含一个存储单元26。评价用电子设备24借助于存储在存储器26中的用于描述所需浓度C和测试值R的函数关系的评价曲线，即CA＝f(R)，算出所要寻找的被分析物质的浓度C并将这些元件分析数据CA输入到存储器26进而存储在该存储器中。分析数据CA自动地或通过特殊指令显示在显示器21中。
可以将评价曲线CA＝f(R)永久地储存在中央单元3中。然而，最好是对每一批新生产的分析元件12使用独立的、一组专用的评价曲线并通过合适的数据媒体将其以机器可读出的形式传输到中央单元。为此，中央单元包括一个数据读出器28，例如，条形码读出器以读出固定在分析元件本身或其它码载体上的条形码。该条形码包含在每一组分析元件上并且包含一组专用的评价曲线。更详细的内容公开在欧洲专利申请0492326中。
除了上述在分析元件评价仪器中的传统功能部件之外，中央单元3还包括用于对数据进行无线传输的无线电收发器29，和传感器校正装置30，该校正装置在实际中最好由软件构成，因此在图3中示为微机25的一部分。这些部件以下面将要进一步描述的方式将分析元件分系统与传感器分系统相连通。
传感器单元2的基本单元5包含与至少一个传感器7相连的传感器电子设备32。这个传感器电子设备32包括用于操作传感器7并进而在患者身体上测量与葡萄糖浓度有关的参数的元件。最佳实施例包括光照射装置，该装置可以是装在传感器7本体上并通过电缆9供电的发光二极管。此外，在基本元件5中可以采用一个或多个光源，包含光纤的电缆9将光输送到传感器7中。相应地，在传感器7和/或基本单元6中设置半导体光探测器以便探测与患者的组织相互作用之后的光。传感器电子设备还进一步包括诸如放大器之类的电子器件以便将接收到的信号处理成与被分析物质的浓度有关的传感器测量值S。将传感器测量值S送至传感器评价装置33，该装置最好是以微机系统34的部件的形式构成，微机系统34还包括存储单元其与基本单元6合为一体。实际上其与分析元件评价仪器24相似。传感器评价装置33利用存储在存储单元35中的评价曲线CS＝g(S)并通过测量值S算出分析数据(浓度)C，所说的计算实际上是由软件控制的。将评价曲线CS＝g(S)以无线的方式从中央单元3输送到基本单元6。为此基本单元6上装有无线电收发器36，该收发器可与中央单元上的无线电收发器29共同作用实现两个单元3、6之间的无线数据传输。
将算出的浓度数据CS储存在存储单元35中。这些数据可以不受中央单元3的控制通过输出单元38输出，基本单元6中的输出单元38的设计应选择最小尺寸和最小的电池能耗。它的主要目的是在葡萄糖浓度的临界极限值超过危险范围的情况下发出警告。合适的是输出单元38可以由带有三个发光二极管(正常范围，高糖危险，低糖危险)的发光二极管显示器构成。此外，还可以提供声信号。
图2中还示出了作为基本单元6一部分的电源电池40。该电池很重要，因为分析传感器的能耗比较高。因此，电池40应该是可再充电的而且应在基本单元6中组合一个电压监视器(未示出)以便及时地发出需要更换电池的警报。
在使用本发明的分析系统对，带有传感器单元2的患者可以离开静置的中央单元3一段时间而不会出现问题。在这段时间内，传感器分析数据CS存储在存储器35中。回家后，当患者离中央单元3足够近使得单元3和6之间可进行无线数据交换时，可使同时得到的传感器分析数据CS从存储器35传送到中央单元的存储器26中。患者可用分析元件12在任何时间进行校正。合适的是，中央单元3包括提醒患者借助校正用分析元件经常进行分析的时间保持装置。每次进行这样的分析时，在中央单元3中确定一条新的评价曲线CS＝g(S)并将该曲线传输到传感器单元2。下面将讨论在整个系统校正期间单元3和6的结合情况。
如上所述，元件分析数据CA是通过评价曲线CA＝f(R)进行校正的，评价曲线最好是以机器可读码的形式通过数据读出器28输入到存储器26中。因此，由分析元件产生的分析数据CA将是足够准确的。当患者刺破他/她的手指得到血滴41，然后，借助分析元件12和测量及评价用电子设备23、24进行分析时就可获得CA值。这种测量可以以一定的时间间隔进行，例如，一天进行一次或二次。图3表示以数据点39的形式在时间t1到t5测得的分析数据。
通过用于测量和评价的电子器件32、33，传感器7产生传感器分析数据CS，所说的数据产生应连续进行或以如此小的间隔进行，即实际上将连续的CS值序列存储在存储器35中并且当单元2和3处于数据相互传输模式时能够将序列值输送到中央单元3。图3用虚线A表示CS值的时间函数。元件分析数据CA用于校正传感器分析数据CS。该过程例如可用这样的方式进行，即在每一次校正时间t1到t5由校正单元30对分析数据CA和存储在存储器26中的CS进行比较。传感器校正装置30通过比较后确定一条新的、正确的评价曲线CS＝g(S)，然后，通过无线电收发器29、36将该曲线传输到基本单元6上，在此，存储器35将采用新的评价曲线借助传感器评价用的电子设备33对以后的传感器分析数据进行计算。在校正期间确定的新的评价曲线CS＝g(S)可同时用于对至少早在前面进行元件分析时就已存储在存储器26中的传感器分析数据进行反校正。因此，就图3所示的实例而言，根据在时间t2获得的浓度值CA(t2)可以对时间t1的值进行校正。类似的思路可用于从时间t3反推到时间t2等。校正后传感器分析数据的正确函数在图3中用实线B表示。
该校正方法仅作为例子描述。很显然，它还可以用不同的方式来完成，特别是那些适应于用来测定分析数据CS或CA的特定评价方法的方式。用于根据大量测试值(例如在很多波长下的强度值)测定一个浓度值CS的数字数学方法是特别适用的，这些方法之一是部分最小二乘法。
传感器单元2和中央单元2和3中的存储器35和26的存储容量分别与特定的用途相配匹。存储器35仅用于相对少量数据的中间存储，也就是说，仅存储在患者与他/她的传感器单元2一起离开中央单元3的最大时间间隔期间的浓度值。存储器35的容量优选能足以存储在至少两个小时，最好八个小时时间间隔内产生的数据量。通常，中央单元3的存储器26实际上更大并且能够存储在超长时间间隔(至少一星期)产生的分析和校正数据。合适的是在中央单元3上装有接口(未示出)由此根据后续处理的需要将所说数据传输到储存患者数据的医院中使用的PC机上。
如图1所示，中央单元3上的分析数据显示器可以是字母数字式的。中央单元3的显示器21最好是图形式的并且可以用图形表示传感器分析数据的时间序列。例如，在图4中所示的显示器中，瞬时葡萄糖值用中间黑带50表示。灰光显示区51对应于葡萄糖值的标准区域，而黑灰色区52表示上警告区(有高血糖的危险)并且下黑色区是下警告区(有低血糖的危险)。在显示器中箭头54表示葡萄糖值有升高的趋势。
在图5的曲线显示器中示出了在超过更大时间间隔内葡萄糖值的时间函数。在显示器的中部两个警告限56、57表示葡萄糖值的标准范围。葡萄糖值序列示为较宽的线58。有时该线58已经处在图5中的上警告区内，这时就需要例如注射胰岛素，即开始降糖。
图4和图5的图形显示器使本发明的系统具有能可靠地和实际上连续地确定葡萄糖值的特殊能力。为此，中央单元3的评价装置24(在此也表示基本单元6的评价装置33)最好还包括软件驱动的鉴别器以允许在任何时间对葡萄糖值序列和对该葡萄糖值的趋势进行测定。这种附加信息对糖尿病的治疗具有很高的价值。

Claims (12)

1.一种用于监测患者血液中待分析物质浓度的分析系统，包括：
含有试剂的分析元件(12)，该试剂在所说元件与患者血滴接触之后和待分析物质发生反应并在分析元件(12)中发生可测量的变化，所说变化与所说待分析物质的浓度有关；和评价仪器，其包括用于测量所说变化的测量装置(23)和评价装置(24)，该评价装置根据测量装置获得的测量值来确定表示元件分析数据CA的分析数据；
其特征在于：所说分析系统进一步包括(ⅰ)可在患者身体上移动的传感器单元(2)，所说的传感器单元(2)包含装在患者身体上以便对与待分析物质浓度有关的参数进行直接和无试剂测量的传感器(7)以及用于对数据信号进行无线传输的发送器(36)，和(ⅱ)传感器分析装置(34)，该装置用于根据由所说传感器测得的所说参数的测量值确定传感器分析数据CS；和所说评价仪器进一步包括(ⅰ)接收器(29)，其用于以无线形式接收来自传感器单元(2)的数据信号，(ⅱ)校正装置(30)，其根据元件分析数据CA对传感器分析数据CS进行校正和(ⅲ)
数据存储器(26)，其用于长期储存分析数据，由此，所说的评价仪器构成了整个分析元件/传感器监测系统(1)的中央单元(3)。
2.根据权利要求1所述的分析系统，其特征在于，所说的传感器单元(2)包括将光照射到患者身体局部组织上的光源和光探测器，该探测器在光与所说身体局部组织相互作用后对光进行探测以便确定随光与组织的相互作用而变化的物理光特性，从而构成与患者血液中待分析物质浓度有关的参数，根据所说的参数来确定传感器分析数据CS。
3.根据权利要求1和2中任何一项所说的分析系统，其特征在于，所说的传感器单元包括基本单元(6)和通过电缆(9)与基本单元(6)相连的传感器(7)，所说的基本单元还有用于传感器单元的电源(40)。
4.根据权利要求3所述的分析系统，其特征在于，所说的传感器单元(2)包括至少两个通过电缆(9)与同一个基本单元(6)相连的传感器(7，8)。
5.根据上述任何一项权利要求所述的分析系统，其特征在于，所说传感器单元(2)包括用于确定所说传感器分析数据CS的传感器分析装置(33)。
6.根据权利要求5所述的分析系统，其特征在于所说的传感器单元(2)包括显示装置38，其用于显示表示所说传感器分析数据CS的信息。
7.根据权利要求5或6中任何一项所说的分析系统，其特征在于，所说传感器单元(2)的发送器(36)和所说中央单元(3)的接收器(29)适于构成在传感器单元(2)和中央单元(3)之间进行相互闻数据交换的收发器系统。
8.根据上述任何一项权利要求所述的分析系统，其特征在于，传感器单元(2)包括存储器(35)，其适用于存储在至少两个小时最好是在八个小时的时间间隔内确定的传感器分析数据CS。
9.根据上述任何一项权利要求所述的分析系统，其特征在于，中央单元包括图形显示器(21)，其用图形表示传感器分析数据CS的时间函数关系。
10.根据权利要求9所述的分析系统，其特征在于，在图形显示器上可以显示传感器分析数据的时间函数关系或它们的变化趋势的多个不同显示模式(50-54；56-58)。
11.用于操作上述任何一项权利要求所述系统的方法，其特征在于，在用分析元件确定浓度值时，将所说的元件分析数据CA作为校正传感器分析数据CS的标准值。
12.根据权利要求11所述的方法，其特征在于，基于所说的标准值对传感器分析数据进行自动的反校正直到分析元件的前一次元件分析时为止。
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