CN1237885A - 血压的非侵入性无套测定 - Google Patents

血压的非侵入性无套测定 Download PDF

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CN1237885A
CN1237885A CN97199737A CN97199737A CN1237885A CN 1237885 A CN1237885 A CN 1237885A CN 97199737 A CN97199737 A CN 97199737A CN 97199737 A CN97199737 A CN 97199737A CN 1237885 A CN1237885 A CN 1237885A
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霍华德·L·戈吕布
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Abstract

采用检测EKG(12)并选择它的一个准点，优选为R－波，来测定被治疗者(10)的动脉血压。优选采用体积描记装置(14)在被治疗者身体的选定部位，比如指尖(16)，监测相对于时间的血容量。从而测定在EKG上出现所选准点和在所选身体部位上出现所选择的血容量变化之间的时间差。该时间差取决于血容量相对于时间的变化曲线以外，还取决于末端位置的脉冲到达时间。从EKG可以确定心率。从脉冲到达时间，容量波形状及每个脉冲的瞬时心率可以计算出动脉压力。所公开的方法用来确定舒张期压力、收缩期压力和平均动脉压力。另一方面，能够进行人为现象的检测和排除。本发明提供了一种以非侵入性、无套方式连续测量血压的方法。

Description

血压的非侵入性无套测定
发明背景
几种不同的动脉血压参数给出了在医学上有用的信息，它们包括收缩期压力、舒张期压力、平均动脉压力、脉冲压力和连续动脉压力。测量它们的传统方式可以如下分类：血压计(有套测量)，自动血压计和留置动脉线转导(A线)。
连续动脉血压作为一个医学指标的重要性已经刺激了其测量新方法的开发。它们包括外部压力转导，光体积描记术(photo-plethysmography)和脉冲波传播计时。直到现在，这些最近的方法主要处于试验使用阶段。
最广泛使用的常规方法--血压计给出收缩期和舒张期的压力。自动的(压力)套采用机械驱动的泵来使其充气，且用算法和传感器来监听最初的和无限制的动脉流动。然而，有套的方法在每次测量期间限制了血液的流动，因此它们不适于连续测量，而且，许多自动套式系统所进行的血压测定不能满足精度要求。套还会使病人产生不舒适感，还会影响血压的读数。
当必需进行连续测量时，采用A线，在没有信号人为因素，也没有比如线卷曲、凝血以及留置换能器和动脉壁之间接触等因素期间，A线具有合理的精度。然而，换能器需要以手术方式插入，且会造成血栓形成和感染。由于该方法必须有一个手术过程，很少使用，即使在需要连续测量血压时也常常不被推荐使用。
提到实验方法都试图采用外部血压连续测量方法来绕过A线的缺点。已经开发了直接外部传感和问题计算方法。
直接非侵入性方法采用外部压力转导。一个压力换能器相对于一条恰好在皮肤底下的动脉一对如桡骨动脉放置，而且通过推动动脉壁来机械地传感压力。然而，由于换能器是传感力的，极易受到机械噪声和运动人为因素的影响。难以进行连续测量的困难在于换能器阻碍了血的流动。困难还在于使换能器在动脉上面保持恰当定位状态。所以，考虑了非直接的测量方法。
脉冲波传播时间测量是一种从每个心脏周期产生的脉冲波的速度推断动脉血压的方法。然而，尽管速度与血压是相关的，迄今所发明的方法假设这种联系是线性的，但是，即使情况果真如此，也许传播时间本身给出了太少有关脉冲波的信息，从而不能精确地确定血压。该方法的另一个缺点是不能给出收缩期和舒张期的两个压力，而许多医学从业人员发现这二者是有用的。
光体积描记术，一种跟踪动脉血量和血中氧含量的技术，导致了连续地推断血压的另一种非直接方法。然而，基于这一点的方法，从容量数据中获取信息，好象血量和血压一样似的，也好假定：血压和血容量曲线是相似的，这有时是对的，但不足普遍现象。再有，光体积描记测量是在身体的末端进行的，比如耳垂和指尖，而在身体边缘观察到的血压，通常与更中间的测量所得是不一样的。
因为A线插入就确定血压而言被认为是一种侵害性太大的方法，而目前还没有能取代它的实用的非手术性连续测量方法，所以这方面的要求仍然存在。
发明概述
一方面，根据本发明的测定一个受治疗者的动脉血压的方法包括为受治疗者检测EKG信号。在EKG信号上选择一个准点，且在受治疗者的选定部位监控血容量相对于时间的波形状。从EKG信号确定瞬时心率并从瞬时心率和血容量相对于时间的波形状计算出动脉压力。在一个实施方案中，准点为R波，而动脉压力是采用血容量相对于时间的波形状中一个选定的血容量变化来计算的。优选地，所选定的血容量变化在波形状上坡的20％至80％范围内。更优选地，所选定的血容量变化在40％至60％范围内。最优选地，所选定的血容量变化大约在容量波前上坡的50％处。所选择的身体部分优选为末端，比如指尖。
另一方面，根据本发明的测定一个受治疗者的动脉血压的方法包括为受治疗者检测EKG信号且在脉冲期间在EKG上选择一个准点。在受治疗者的选定部位监控血容量相对于时间的变化。在所选的身体部位上，确定在所选的EKG准点的出现和所选的血容量变化的出现之间的时间差。从EKG确定心率且根据该时间差和心率计算出动脉血压。在一个优选实施方案中，准点为R波而身体部位为末端，比如指尖。一个优选用来监测血容量的方法是采用光体积描记术。计算出来的动脉压力可以是舒张期的，收缩期的或平均动脉压力。
在又一方面，根据本发明的测定动脉血压的装置包括检测心脏电活动的EKG设备。响应血容量变化的设备可以包括光体积描述设备。来自EKG设备和血容量监控设备的输出被引入到一个信号处理器或计算机中，由其计算出动脉血压。
在再一个方面，信号处理和计算设备被用来检测在血压测量过程中的人为因素(artifacts)并排除这些人为因素。这些技术可以用来可靠地评价每个脉冲的血压计算的置信度。这里所公开的技术给出了一个在良好输入信号期间可靠性好得多的血压测值，并且在输入信号质量不佳时告知使用者不能得到测值。
本发明提供了一种连续地、无侵入性且无血压套的测量动脉血压的方法和装置。由于能自动检测和排除人为因素，可以可靠评价每个脉冲的血压计算的置信度。
附图简述
图1为本发明的装置的一个示意图。
图2为EKG和血容量相对时间变化的图。
优选实施方案的描述
波在弹性管中传播的物理原理是理解本发明的基本概念的一个重要因素。压力脉冲在弹性管中传播速度的一个最简单的公式最早是由Moens-Kortweg描述的，他们从实验证据和理论基础建立了以下公式：
c=(Eh/2Rδ)1/2其中，c是波的速度，E和h是杨氏模量和动脉壁的厚度，δ是流体的密度，R是管子的平均半径。
为了排除测量管壁厚度和杨氏模量的实验上的困难，Moens-Kortweg公式由Bramwell和Hill(1922)进行了修正，从而使管子的弹性行为由其压力一容量的可伸性能力来表述。公式可被简化为：
c={V/[δ(V/P)]}1/2=[(VP)/(δV)]1/2或
ΔPαc2(ΔV/V)其中V为动脉的初始容量，ΔV为导致压力脉冲ΔP的容量变化，c为脉冲波速度。
于是，困难在于确定一种非侵入性的方式来测量脉冲波速度和动脉容量的百分数变化。为了达到这个目的，我们选择采用标准EKG信号和任何稳定的血容量相对时间变化的测量方法(比如在优选实施方案中的光体积描记述)。
采用EKG信号和血容量相对于时间变化信号的方法首先包括测量第i个脉冲的TR_50(i)(R-波在EKG上达到容量相对时间变化曲线上坡50％点的)时间。这段时间是R-波和脉冲0％点之间的时间(TR_0(i))加上脉冲0％点到上坡上50％点之间的时间(T0_50(i))之和。如前面的定义(或c=1/TR_50(i))，TR_0(i)的倒数等于脉冲的速度，而T0_50(i)与ΔV和V的关联更大。因此，TR_50(i)的测量是一项与c,ΔV和V有关的测量。
于是，第i个脉冲的总脉冲速度(Vp(i))就等于TR_50(i)的倒数，而总脉冲速度的平方(v2 p(i))只要将vp(i)平方即可获得。另外，可以确定第i个压力脉冲的瞬时R-R间隔时间和由此获得的瞬时心率(分别为RRi)和IHR(i))，且用来计算第i个脉冲的舒张期的、收缩期的和平均的压力(分别为PD(i),PS(i)和PM(i))。在计算舒张期压力中，R-R间隔或者IHR的重要性的理论基础可以如下概括。舒张期压力被定义为在舒张压力衰减停止时的动脉压力。这种舒张期压力的指数衰减在主动脉瓣关闭时开始，在主动脉瓣开启时结束。压力衰减率取决于许多因素，包括在收缩期中的主动脉压力积累和系统的动脉阻抗(与动脉系统，尤其是小动脉的管壁的刚性有关)。因此对一个给定的个体而言，这种衰减在任何给定的心脏博动(或舒张期压力)下所降到的压力与这种衰减被允许继续进行下去的时间长短有关。任何给定的脉冲的这种衰减期正比于该脉冲的瞬时R-R间隔，或者反比于其IHR。所以，衰减期越短(IHR越高)，舒张期的压力将会越高，而如衰减期越长(IHR越低)，舒张期的压力会越低。概括起来，第i个压力脉冲的压力计算公式如下：
                  IHR(i)=1/RR(i)
         vp(i) 2=(1/TR_50(i))*(1/TR_-50(i))
   PD(i)=(KDv *vp(i) 2)+(KDihr *IHR(i))+KDcal
         PS(i)=(KScal *vp(i) 2)+KSconst
        PM(i)=(PS(i)-PD(i))*1/3+PD(i)
在这些公式中，KDv,KDihr和KSconst是常数，在优选实施方案中分别为2.5,0.5和35，其中KDcal和KScal是校准常数。PD(i),PS(i)和PM(i)分别为舒张期、收缩期和平均的动脉压力。
本发明的实施将结合附图进行描述。在图1中，一个受治疗的人10用EKG导头来监测，用12一般地表示。在本领域的熟练者都认可一般采用多个导头来测量EKG。光体积描记装置14在受治疗者10的指尖16监测血容量。从EKG装置12和光体积描记装置14输出的信号在一台计算机或信号处理器18中处理且产生一个输出血压信号，如上所述，可以是每个脉冲的舒张期压力、收缩期压力或平均动脉压力。参见图2，处理器18检测R-波的到来。此外，血容量测量装置14检测在时间TR_0(i)血容量变化的开始，且在容量相对时间变化曲线上坡上确定达到50％点(T0_50(i))的时间。如图2中可见，从脉冲零百分数(TR_0(i))的到来，到上坡上50％点(T0_50(i))的时间，取决于容量相对于时间变化曲线的斜率。由于本发明采用了从R-波到达到零百分数容量变化点以及从零百分数容量变化点到50％点的时间，确定压力的精度高于现有技术，现有技术要么采用脉冲到达时间，要么采用波形状，而不象本发明这样采用二者的结合。
本发明的另一方面包括自动检测人为因素和排除人为因素的方法，并由此可以对每个脉冲的每次血压计算的置信度有可靠的评价。这些人为因素的排除方法包括计算每个脉冲的两个附加变量。对第i个脉冲来讲，它们如下表示：
      qvp(i) 2=(ivp(3) 2_1vp(1) 2)/1vp(2) 2其中ivp(1) 2是：选出5个连续的vp 2项{vp(i-2) 2,vp(i-1) 2,vp(i) 2,vp(i+1) 2,vp(i+2) 2}中第二个最低值，1vp(2) 2是中间值，ivp(3) 2是第二个最高值。且
      diffvp(i) 2=vp(i) 2-vp(i-1) 2
检测第i个脉冲是否是人为因素的算法涉及测试这些变量是否高于预先确定的阈值。在优选实施方案中，测试包括下二者是否有一项满足：
qvp(i) 2＞THRESH_qv
diffvp(i) 2＞THRESH_diffy其中THRESH_qv的优选值为0.8,THRESH_diffv为8.0，更具体地，这些变量被用来与下面的其他方法一起来确定PD(i)计算的人为因素。该算法包括是否：
            qvp(i) 2＞THRESH_qv
            或
            PD(i)＜PD_TOOLOW
            或
            PD(i)＞PD_TOOHIGH
            或
            PD(i)＞Ps(i)其中，在优选实施方案中，PD_TOOLOW=30,P_TOOHIGH=150。如果上述任一条是正确的，那么就视为第i个脉冲的舒张期压力(PD(i))不能被求出。
具体地，以类似的方式，PS(i)计算的人为因素的确定包括是否：
            qvp(i) 2＞THRESH_qv
            或
            diffvp(i) 2＞THRESH_diffv
            或
            Ps(i)＜PS_TOOLOW
            或
            Ps(i)＞PS_TOOHIGH
            或
            PD(i)＞Ps(i)其中在优选实施方案中，PS_TOOLOW=50,PS_TOOHIGH=200。如果上述任一条是正确的，那么就视为第i个脉冲的收缩期压力(PS(i))不被求出。
最后特别说明，如果
                PD(i)是不能被求出的
            或
            Ps(i)是不能被求出的那么第i个脉冲的PM(i)计算的确定将归纳为是人为因素，且如果二条中的一条是正确的，则视为第i个脉冲的平均压力不能被求出。

Claims (35)

1、确定一个受治疗者动脉血压的方法，包括
为受治疗者检测EKG信号；
在EKG信号上选择一个准点；
在受治疗者的选定部位监测血容量相对于时间的波形状；
从EKG信号确定瞬时心率；以及
从瞬时心率和血容量相对于时间的波形状变化计算动脉血压。
2、如权利要求1所述的方法，其中的准点是R-波。
3、如权利要求2所述的方法，其中的准点是R-波的尖峰。
4、如权利要求1所述的方法，其中的计算步骤包括采用在血容量相对于时间的波形状上一个选定的血容量变化。
5、如权利要求4所述的方法，其中所选定的血容量变化在波形状上坡的20％至80％范围内。
6、如权利要求4所述的方法，其中所选定的血容量变化在波形状上坡的40％至60％范围内。
7、如权利要求4所述的方法，其中所选定的血容量变化大约在波形状上坡的50％处。
8、如权利要求1所述的方法，其中所选择的身体部分为末端。
9、如权利要求8所述的方法，其中的末端为指尖。
10、如权利要求1所述的方法，其中监测血容量相对于时间的变化包括采用光体积描记术。
11、确定一个受治疗者动脉血压的方法，包括
为受治疗者检测EKG信号；
在一个脉冲期间，在EKG信号上选择一个准点；
在受治疗者身体的选定部位监测血容量相对于时间的变化；
确定在所选的身体部位上所选的准点的出现和所选的血容量变化出现之间的时间差；
从EKG确定心率；以及
根据时间差和心率计算动脉血压。
12、如权利要求11所述的方法，其中准点是在R-波上的一个点。
13、如权利要求12所述的方法，其中准点是R-波的尖峰。
14、如权利要求11所述的方法，其中所选的血容量变化在20％至80％的范围内。
15、如权利要求11所述的方法，其中所述的血容量变化在40％至60％的范围内。
16、如权利要求11所述的方法，其中所选的血容量变化在约50％。
17、如权利要求11所述的方法，其中所选的身体部分为末端。
18、如权利要求17所述的方法，其中的末端为指尖。
19、如权利要求11所述的方法，其中监测血容量相对于时间的变化包括采用光体积描记术。
20、如权利要求11所述的方法，其中的动脉压力是舒张期的压力。
21、如权利要求11所述的方法，其中的动压力是收缩期的压力。
22、如权利要求11所述的方法，其中的动脉压是平均动脉压力。
23、如权利要求20所述的方法，其中舒张期压力PD(i)是通过计算
PD(i)=(KDv *vp(i) 2)+(KDihr *IHR(i))+KDcal
Vp(i) 2=(1/TR_50(i))*(1/TR_50(i))来确定的，其中于TR50(i)为在所选身体部位上所选的准点的出现和血容量变化出现之间的时间差；KDv和KDihr是常数，KDcal是一个校准常数；而IHR(i)是瞬时心率。
24、如权利要求23所述的方法，其中KDv约为2.5,KDihr约为0.5。
25、如权利要求21所述的方法，其中收缩期的压力PS(i)通过计算
PS(i)=(KScal *vp(i) 2)+KSconst来确定，
其中KSconst是一个常数，KScal是个校准常数。
26、如权利要求25所述的方法，其中KSconst约为35。
27、如权利要求22所述的方法，其中平均动脉压力PM(i)通过计算
PM(i)=(PS(i)-PD(i))*1/3+PD(i)来确定。
28、确定一个受治疗者动脉血压的方法，包括：
为受治疗者检测EKG；
在一个脉冲期间，在EKG上选择一个准点；
在受治疗者身体的选定部位上监测血容量相对于时间的变化；以及
确定在所选准点的出现与开始容量变化的时间和到所选定的血容量变化的时间之和之间的时间差，它是血容量波形状的函数。
29、如权利要求28所述的方法，其中所选的血容量变化约为50％。
30、如权利要求29所述的方法，其中所选的准点是R-波，而所选的受治疗者的身体部位为指尖。
31、如权利要求28所述的方法，其中监测血容量相对于时间变化采用光体积描记术。
32、人为因素的检测方法，包括：
在一个时间窗口计算一系列脉冲的血压；
确定该系列脉冲的血压分布；以及
从该分布中检测人为因素。
33、检测舒张期压力人为因素的方法，包括：
计算
qvp(i) 2=(ivp(3) 2-ivp(1) 2)/ivp(2) 2其中，ivp(1) 2是{Vp(i-2) 2,vp(i-1) 2,vp(i) 2,vp(i+1) 2,vp(i+2) 2}中的第二个最低值，vi p(2) 2是该容量的中间值，而ivp(3) 2是第二个最高值；
确定舒张期压力，PD(i)；
确定收缩期压力，PS(i)；且
如果qvp(i) 2＞THRESH_qv或如果PD(i)＜PD_TOOLOW或PD(i)＞PD_TOOHIGH或PD(i)＞PS(i)，则确定第i个脉冲的PD(i)是人为因素。
34、检测收缩期压力人为因素的方法，包括：
计算qvp(i) 2；
计算diffvp(i) 2=vp(i) 2-vp(i-1) 2；并且确定收缩期压力和舒张期压力，其中，如果qvp(i) 2＞THRESH_qv或如果diffvp(i) 2＞THRESH_diffv或如果Ps(i)＜PS_TOOLOW或如果Ps(i)＞PS_TOOHIGH或如果PD(i)＞PS(i)，则确定收缩期压力的计算是人为因素。
35、检测平均动脉压力PM(i)是人为因素的方法，计算包括：
确定PD(i)或PS(i)是否是人为因素，其中，如果PD(i)或PS(i)是人为因素，则平均动脉压力是人为因素。
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