CN103796577B - 评估流体填充管中的断面收缩的设备和方法 - Google Patents

评估流体填充管中的断面收缩的设备和方法 Download PDF

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CN103796577B
CN103796577B CN201280004879.6A CN201280004879A CN103796577B CN 103796577 B CN103796577 B CN 103796577B CN 201280004879 A CN201280004879 A CN 201280004879A CN 103796577 B CN103796577 B CN 103796577B
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海伦·凯瑟琳·斯图尔特·戴维斯
贾斯汀·戴维斯
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Abstract

一种在不进行流速测量的情况下评估流体填充管中的断面收缩的设备和方法，所述流体填充管具有流体流动压力波，所述流量压力波具有向后发生的压力分量和向前发生的压力分量，包括：在管中进行压力测量；将压力分量分为向后发生的压力分量和向前发生的压力分量；识别当流速的微分（dU）最小或不存在时的时间窗口；和对于至少在所述时间窗口中进行的压力测量，对向后压力分量和向前压力分量进行求导。

Description

评估流体填充管中的断面收缩的设备和方法
技术领域
本发明涉及一种评估流体填充管中的断面收缩的设备和方法。
背景技术
能够对形成有缩窄或断面收缩的流体填充管或脉管进行分析，以测量缩窄或断面收缩的程度。
形成有缩窄或断面收缩的流体填充管或脉管的实例为具有狭窄的血管。缩窄的评估或测量能够产生用以测定缩窄的程度的有用参数。
一种估计流体填充管中的缩窄，诸如冠状动脉狭窄的标准方法为血流储备分数（FFR）。该技术测量在沿脉管的两点处的压降；参见附图的图1，其中处于冠状环境中的最大可实现充血条件下。Pd测量来自导丝上的压力传感器，并且Pa测量来自导管。然后，通过作为平均近端压力（Pa）的比例来表达平均远端压力（Pd）来做出比较，其中这些数值是在至少一个完整心动周期（但通常是平均3次或更多次心跳）期间获得的在整个心动周期上的平均Pa和Pd：
通常仅能够通过施用有效的血管扩张剂诸如腺苷或双嘧达莫实现最大充血条件。这样的血管扩张剂必需最小化来自远端血管床的阻力，以准确估算横跨狭窄的压降。将优选不使用血管扩张剂。
除了渗透心肌的小微循环脉管的主动压缩之外，远端压力还来自微循环的阻力。当在不同地点同时测量流动时，可以将远端微循环产生的压力分量（向后发生的压力）与近端产生的压力分量（向前发生的压力）分离。
其中dP是压力的微分，ρ=血液密度，c=波速，并且dU是流速的微分。
P+通过清除向后发生的分量而隔离向前发生的压力，并且因此排除了施用血管扩张剂，诸如腺苷。因而通过比较狭窄任一侧上的P+比率，可以在不需要事先最大充血的情况下估算狭窄的严重程度。该隔离向前压力比被表达为：
虽然向前压力比由于不需要施用血管扩张化合物而提供显著的进步，但是除了压力外，其还需要测量流速。这需要相当多的额外技术、另外的硬件和更多花费。
发明内容
本发明的目的是提供一种估算流体填充管中的断面收缩的设备和方法，除了压力测量之外，所述设备和方法不需要测量流速、流体流量。
本发明的一个方面是提供一种在不进行流速测量的情况下评估流体填充管中的断面收缩的方法，该流体填充管具有流体流动压力波，所述流体流动压力波具有向后发生的压力分量和向前发生的压力分量，该方法包括：在管中进行压力测量；将压力分量分为向后发生的压力分量和向前发生的压力分量；识别流速的微分（dU）最小或不存在时的时间窗口；和对于至少在该时间窗口进行的压力测量，对向后和向前压力分量进行求导。
本发明的另一方面是提供一种在不进行流速测量的情况下评估流体填充管中的断面收缩的设备，该流体填充管具有流体流动压力波，所述流体流动压力波具有向后发生的压力分量和向前发生的压力分量，该设备包括：压力测量装置，其可操作用以在管中进行压力测量；和处理器，其可操作用以将压力分量分为向后发生的压力分量和向前发生的压力分量、识别流速的微分（dU）最小或不存在时的时间窗口，和对于至少在该时间窗口进行的压力测量，对向后和向前压力分量进行求导。
本发明的又一方面是提供一种处理器，所述处理器被构造为在不进行流速测量的情况下评估流体填充管中的断面收缩，该流体填充管具有流体流动压力波，所述流体流动压力波具有向后发生的压力分量和向前发生的压力分量，该处理器：分析在流体填充管中进行的压力测量；将压力分量分为向后发生的压力分量和向前发生的压力分量；识别流速的微分（dU）最小或不存在时的时间窗口；和对于至少在该时间窗口获得的压力测量值，对向后和向前压力分量进行求导。
本发明的又一方面是提供一种数据存储介质，所述数据存储介质载有计算机程序，以在不进行流速测量的情况下评估流体填充管中的断面收缩，该流体填充管具有流体流动压力波，所述流体流动压力波具有向后发生的压力分量和向前发生的压力分量，该程序：分析在流体填充管中进行的压力测量；将压力分量分为向后发生的压力分量和向前发生的压力分量；识别流速的微分（dU）最小或不存在时的时间窗口；和对于至少在该时间窗口获得的压力测量值，对向后和向前压力分量进行求导。
附图说明
为了可更易于理解本发明，现在将参考附图描述本发明的实施例，其中：
图1是形成有具有近端（Pa）和远端（Pd）压力测量点的缩窄的管的示意图；
图2是实施本发明的设备的不按比例的示意图；
图3是示出实施本发明的方法的流程图；
图4示出心脏环境中的自由波周期的实例，所述自由波周期在实施本发明的设备和方法中使用。
具体实施方式
本发明提供一种通过测量流体填充管中的压力来评估流体填充管中的断面收缩的设备和方法，并且除了压力测量之外，不需要测量流速、流体流量。
在流体流动系统中，分离压力（separated pressure）如下：
其中dP是压力微分，ρ=血液密度，c=波速，并且dU是流速微分。通过比较缩窄的任一侧上的P+和P-的比率，隔离（isolated）压力比提供缩窄的严重程度的测量、估算或指示。
因而，使用分离压力的隔离向前压力比为：
或者，隔离向后压力比，
使用这种技术计算隔离压力比给出缩窄严重程度的仅关于压力的评估。
参考图2，用于实施本发明的设备1包括探针2，诸如具有压力测量换能器或传感器3—即测量压力（P）的装置的动脉内压力导丝（WaveWire或Combowire（Volcano公司））或Radi压力导丝（美国圣犹达医疗设备公司），以及用以分析和操作压力测量的处理器4。信号线路5将来自换能器3的压力测量信号传递至处理器4。信号线路5被示意为有线连接5和无线连接5'两者—可用任何构造。
处理器4根据下文更详细讨论的若干算法操作从换能器3接收的压力测量。可以下列构造或构造组合设置设备1，但是这些不是构造的详尽列表：
ⅰ包括与处理器有线连接的能够进行压力测量的探针的孤立装置，以提供在装置上分析；
ⅱ包括具有与处理器无线连接的能够进行压力测量的探针的装置，以提供在处理器处的分析；
ⅲ包括能够进行压力测量的探针的孤立装置以及数据存储装置，所述数据存储装置可操作用以实时记录测量数据，或随后传输至处理器，以提供在处理器处的分析（实时和/或线下）；和
ⅳ包括与数据存储装置无线连接的能够进行压力测量的探针的装置，所述数据存储装置可操作用于实时记录测量数据，或随后传输至处理器，以提供在处理器处的分析（实时和/或线下）。
在其中设备1被构造为血液动力器械的部分的心脏环境中，该系统被构造为使用在血液动力器械中的处理器4，所述血液动力器械诸如麦克森器械—HorizonCardiologyTM，一种心血管信息系统（CVIS）。这样的构造对于器械处理器执行压力数据的线下分析是特别有效的。
设备1（特别是探针2）能够与其他血液动力器械、医疗成像器械和/或患者内标识位置设备仪器结合地使用。
在循环流体流动系统中，存在其中流体流动速度的变化率趋向于0，即dU趋向于0的时间窗口。在本文中被称为“自由波时段”的这些时间，可以仅使用压力波形将在测量点处的流体中的波压力分为向前和向后压力。这排除了对流速测量的需要。
在心动周期的具体实例中，在心动周期中的任何点，通过dP+ρcdU确定dP+。dU在心动周期的下列部分期间是大的，即当存在明显比例的波能时（即在左心室收缩期间）。然而，在心动周期中存在dU趋向于0的时间。这能够是单个时刻或时间样本（sample in time），或者能够是多个时刻或多个时间样本。在这样的时间，能够消去dU项，并且单独使用dP项评估dP+或dP-。
根据本发明的该实例，在dU趋向于0的时间或自由波时段期间获得压力样本。不必严格坚持在自由波时段时或该时段期间进行压力取样，但是确实需要在dU的影响最小或优选当其趋向于0时进行压力取样。
在dU的影响最小或完全忽略时的自由波时段或该时段期间，从分离压力消去dU项，所以：
dP+计算为
并且dP-计算为
随着消去dU项，分离压力计算为：
并且
当dU趋向于0时，从该解消去dU项，并且dP+计算为：
并且dP-为：
本发明提供单独使用压力波形来将在测量点处的流体中的波压力分离为向前和向后压力，且消除了对测量流速的任何需要。该进步允许使用不需要测量流体流动速度的技术简化器械。
在实施本发明的设备和方法中，在自由波时段期间并且不是在充血期间的基线（baseline）处进行压力测量。这与其中测量特别地在充血时进行的结合流速和压力测量设备的FFR测量的教导相反。这是因为本发明的实例提取向前压力分量，而非必须通过施用血管扩张剂来最小化来自测量压力的向后压力的影响（如在常规FFR中）。如果在血管扩张的充血期间进行测量，则由于此时dU明显增加，测量值将不可靠。
图4示出dU在一周期期间波动的实例。存在其中dU趋向于0的可辨认窗口（在该实例中，标为580ms到770ms）。例如通过以下方式识别该窗口：由处理器启发地学习；与压力波形的特征关联；或波形中另一事件后的特定时间窗口，例如dUmax[A1]事件后始于预定时间（250ms），并且持续预定时间段（150ms）—注意，能够从波形的压力测量值可靠地观察到dUmax。能够使用在线实时分析或能够使用离线分析确定自由波时段。
例如，在心脏环境中，能够如下执行从压力测量检测最小化的dU（自由波时段）：
确定峰值压力时间（tPmax）；
确定压力波形时间的终点（tPend）；
对从tPmax至tPend的压力测量进行取样；
分析（tPmax+150ms）至（tPend-50ms）=自由波时段的压力测量。
识别自由波时段的另一实例是将其识别建立在压力波形的特征的基础上。这是有利的，因为该识别不被约束于固定时间点。在该具体实例中：
计算隔离向前（或向后）压力比；
计算隔离向前（或向后）压力比的标准偏差；
选择在峰值压力时间点后的以下时间段（自由波时段），其中标准偏差处于最低的5%中，并且如果没有点被识别，则选择其中标准偏差处于最低的10%中的时间段，等等。
测量在识别的自由波时段内持续，和/或持续至少～=100ms时段。
识别自由波时段的另一实例为：
识别峰值压力时间点；
识别压力波时间点的终点；并且
将自由波时段指定为该两个时间点之间的预定部分的中间窗口。优选地，将自由波时段识别为该两个点之间的中间3/5窗口。
在心脏环境中，在下列窗口中进行可靠测量，其中dU从零交叉点变化小于+/-2×10-4，其中dUmax为3×10-3，其中dU为dUmax的20%或更小，优选10%或更小，最优选5%或更小。dU在自由波时段之间在平均值周围振荡，所以由于-ve作用抵消+ve作用，其对分离压力（即P+）的净影响被最小化。在心脏环境中，在自由波时段（时间窗口）期间关于平均值的振荡是由于测量器械中的限制，其将不准确地检测小变化。
此外，该进步还提供使用隔离压力比的测量来测量缩窄严重性。
此外，该进步还消除了在心脏环境中对施用有效血管扩张剂的需要。
在心脏环境中，对于简化器械，存在具有最小可能覆盖区（或者为需要最小可能入口的微创）的特殊需要，所以提供仅具有安装在探针上或探针中的一个测量装置的隔离压力比测量装置或探针代表了本领域的明显技术进步。
此外，心脏领域中的这样的装置或探针包括来自探针的信号线，所述信号线终止在用于向处理器发送测量信号的发射器或处理器本身中。如果存在流量传感器和压力传感器，则该两个不同的测量装置就处于相同的探针中/相同的探针上，并且还存在需要从该两个不同的测量装置获得信号的两条信号线。在本发明的实例中，从系统失去流量传感器是极其有利，因为这样这降低了装置的复杂性、能够提高探针的操作并且能够减少从测量装置获取测量信号必需的信号线路的数目。在本发明的实例的情况下，仅存在一个测量装置—压力测量装置，并且消除了对一个或多个压力传感器外的流量传感器的需求。单根压力传感器导线能够比具有压力和流量传感器两者的导线更可操纵。除了压力传感器，还具有流量传感器是次优导线设计。
仅相对于缩窄获得压力测量。优选，能够进行多次测量，而不是一次测量。探针2能够相对于缩窄移动，在该情况下，将进行多次测量。
存在上述设备和方法的进一步混合，其涉及识别自由波时段—循环流动中dU趋向于0的那些时间。本领域技术人员能够计算和识别自由波时段—如它们在波活动性最小或缺失时的心动周期的时段期间发生。
对于从时间点tw0至时间点tw1的给定自由波时段，P+（任何自由波时段tw0至tw1期间）为，
和P-为，
其中P+近端定义为，
并且P+远端定义为，
并且P-近端定义为，
并且P-远端定义为，
因此，使用分离压力的隔离压力比为隔离向前压力：
或者隔离向后压力，
使用该技术计算自由波时段期间的隔离压力比给出缩窄诸如狭窄的严重性的仅关于压力的评估。除了压力测量换能器3之外，不需要在探针2上提供流速测量器械，并且不需要处理任何流速测量值。
当在本说明书和权利要求书中使用时，术语“包含…”和“包括…”及其变体意思意味着包括特定特征、步骤或整体。这些术语不应被解释为排除其它特征、步骤或部件的存在。
为了实现本发明的不同形式，视需要，上文说明书或下文权利要求书或附图中，以它们的特定形式，或以执行公开功能的装置，或实现所公开结果的方法或过程所公开的特征能够单独地或结合地被利用。

Claims (8)

1.一种在不进行流速测量的情况下评估流体填充管中的断面收缩的设备，所述流体填充管具有流体流动压力波，所述流体流动压力波具有向后发生的压力分量和向前发生的压力分量，所述设备包括：
压力测量装置，所述压力测量装置可操作以在所述管中进行压力测量；和
处理器，所述处理器可操作用于
将压力测量值分为所述向后发生的压力分量和所述向前发生的压力分量；
基于所述压力测量值识别当流速的微分(dU)最小或不存在时对应的时间窗口；
对于至少在所述时间窗口中获得的所述压力测量值，对所述向后发生的压力分量和向前发生的压力分量进行求导；并且
基于求导过的向后发生的压力分量和向前发生的压力分量中的至少一个压力分量来计算压力比，所述压力比指示所述流体填充管中的断面收缩的严重程度。
2.根据权利要求1所述的设备，其中在所述时间窗口期间，所述处理器还对所述向后发生的压力分量和向前发生的压力分量进行求导。
3.根据权利要求1或2所述的设备，其中所述处理器还识别所述时间窗口。
4.根据权利要求1或2所述的设备，其中所述设备还包括所述压力测量装置和所述处理器之间的有线连接。
5.根据权利要求1或2所述的设备，其中所述设备还包括所述压力测量装置和所述处理器之间的无线连接。
6.根据权利要求4所述的设备，其中所述压力测量装置将所述压力测量值传送至数据存储装置，所述数据存储装置存储所述压力测量值并且远离所述处理器。
7.根据权利要求5所述的设备，其中所述压力测量装置将所述压力测量值传送至数据存储装置，所述数据存储装置存储所述压力测量值并且远离所述处理器。
8.一种评估流体填充管中的断面收缩的设备，包括：
处理器，所述处理器被构造成在不进行流速测量的情况下评估所述流体填充管中的所述断面收缩，所述流体填充管具有流体流动压力波，所述流体流动压力波具有向后发生的压力分量和向前发生的压力分量，所述处理器：
分析在管中进行的压力测量；
将压力测量得到的压力分量分为所述向后发生的压力分量和所述向前发生的压力分量；
识别当流速的微分(dU)最小或不存在时的时间窗口；
对于至少在所述时间窗口中进行的压力测量，对所述向后发生的压力分量和向前发生的压力分量进行求导；并且
基于求导过的向后发生的压力分量和向前发生的压力分量中的至少一个压力分量来计算压力比，所述压力比指示所述流体填充管中的断面收缩的严重程度。
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US20120278008A1 (en) 2012-11-01
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US20150230714A1 (en) 2015-08-20
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