CN103190951B - 基于相位测量的接触评价 - Google Patents

基于相位测量的接触评价 Download PDF

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CN103190951B
CN103190951B CN201310001985.5A CN201310001985A CN103190951B CN 103190951 B CN103190951 B CN 103190951B CN 201310001985 A CN201310001985 A CN 201310001985A CN 103190951 B CN103190951 B CN 103190951B
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A.戈瓦里
A.C.阿尔特曼
Y.埃夫拉思
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Abstract

本发明名称为“基于相位测量的接触评价”。本发明提供了实现组织消融的方法和***，所述方法和***通过以下方式执行：将具有消融电极的探针***活体受检者体内，并且当所述消融电极与靶组织为非接触关系时，对流过所述消融电极与另一个电极之间的电流的相位进行接触前测定。将所述消融电极设置为与所述靶组织接触，并且当所述消融电极处于接触关系时，经由所述消融电极对所述靶组织施加一定剂量的能量，以便对所述靶组织进行消融。对所述电流的所述相位反复地进行术中测定。当所述术中测定中的一次测定满足终止准则时，终止施加所述能量。

Description

基于相位测量的接触评价
背景技术
技术领域
本发明涉及组织消融***。更具体地讲，本发明涉及监视侵入型探针和体内组织之间的接触。
背景技术
当心脏组织区向相邻组织异常地传导电信号时，发生诸如心房纤颤之类的心律失常，从而扰乱正常的心动周期并造成心律不同步。
用于治疗心律失常的手术包括通过手术扰乱造成心律失常的信号源，以及扰乱用于这种信号的传导通道。通过经由导管施加能量来选择性地消融心脏组织，有时可以终止或更改不利电信号从心脏一部分传播到另一部分。消融方法通过形成非传导性的病变来破坏无用的电通道。
验证电极与靶组织的物理接触对于控制消融能量的递送来说非常重要。本领域已针对验证电极与组织的接触进行大量尝试，并且已提出多种技术。例如，美国专利No.6,695,808描述了用于治疗选定的患者组织或器官区域的设备。探针具有可推抵所述区域的接触表面，由此产生接触压力。压力传感器测量所述接触压力。手术过程中医疗器械必须牢固放置，但是不与解剖表面过度接触，该装置据说通过给医疗器械的使用者提供接触力的存在和大小的指示信息来满足所述手术过程的需要。
又如，美国专利No.6,241,724描述了用分段电极组件在身体组织内产生病变的方法。在一个实施例中，导管上的电极组件载有压力传感器，该传感器感测与组织的接触情况并向压力接触模块传递信号。所述模块识别与压力传感器信号相关的电极元件，并指示能量发生器将RF能量传送至这些元件，而不传输至仅与血液接触的其他元件。
美国专利No.6,915,149中提供了另一个例子。该专利描述了用具有测量局部电活动的末端电极的导管来标测心脏的方法。为了避免可能因末端与组织接触不良而产生的假象，使用压力传感器测量末端与组织之间的接触压力，以确保稳定接触。
美国专利申请公布2007/0100332描述了用于评价组织消融的电极组织接触的***和方法。导管轴内的机电式传感器产生对应于导管轴远侧部分内电极移动量的电信号。输出装置接收用于评价电极与组织之间接触水平的电信号。
授予Keidar等人的美国专利No.7,306,593描述了通过以下步骤消融器官内组织的方法：将体内的探针与待消融的组织接触，并在消融组织之前使用探针测量该位置处的一个或多个局部参数。显示器官的标测图，根据一个或多个局部参数示出对于用探针在该位置处施加的给定剂量的能量可达到的组织预测消融范围。使用探针施加给定剂量的能量来消融组织，并在消融组织之后使用探针测量该位置处的实际消融范围。在标测图上显示测量的实际消融范围，以与预测范围进行比较。
本领域已知的用于评价导管组织接触的基于阻抗的方法通常依赖于对导管上电极与体表电极之间的阻抗大小的测量。当阻抗大小低于某些阈值时，视为电极与组织接触。然而，这种二极接触指示可能不可靠，并且对于体表电极与皮肤之间的阻抗变化敏感。
Sauarav等人的美国专利申请公布No.2008/0288038和2008/0275465描述了电极导管***，该***可包含适于施加电能的电极，所述专利申请以引用方式并入本文。当电极靠近靶组织时，可以在电极与地面之间应用适于测量阻抗的测量电路。可以应用处理器或处理单元来测定靶组织的接触条件，该接触条件至少部分基于测量电路测得的阻抗的电抗。在另一个实施例中，接触条件可基于阻抗的相位角。
发明内容
根据本发明实施例提供了消融方法，该方法通过以下方式执行：将具有消融电极的探针***活体受检者体内，并且当消融电极与靶组织为非接触关系时，对流过消融电极与另一个电极之间的电流的相位进行接触前测定。该方法还通过以下方式执行：使消融电极与靶组织成接触关系，并且当消融电极处于接触关系时，经由消融电极对靶组织施加一定剂量的能量以便对靶组织进行消融，对所述电流的所述相位反复进行术中测定。该方法还通过以下方式执行：确定术中测定中的一次测定满足消融完成的终止准则，对其进行响应，终止能量施加。
该方法的一个方面包括显示电流相位的术中测定的视觉指示。视觉指示可以包括相对于靶组织中预期病变的消融的进程显示。
根据该方法的另一个方面，终止准则包括小于预定值的、所述术中测定中的一次测定与接触前测定之间的差值。
根据该方法的另一个方面，终止准则包括术中测定中的一次测定与术中测定中的前一次测定的变化未超过阈值。
根据该方法的其他方面，进行接触前测定和术中测定包括测量探针上电极与体表电极之间的阻抗的相位。
根据该方法的一个方面，进行接触前测定和术中测定包括与从参考电极取得的参考波形的相应相位进行比较，所述参考电极与靶组织间隔开。
在该方法的另一个方面，进行术中测定每2-5秒执行一次。
在该方法的另一个方面，进行术中测定和施加一定剂量的能量同时执行。
根据该方法的又一个方面，进行接触前测定在小于10毫瓦的功率下执行。
根据该方法的其他方面，进行术中测定在5-50瓦的功率下执行。
本发明的其他实施例提供了用于执行上述方法的设备。
附图说明
为更好地理解本发明，以举例的方式提供本发明的详细说明。要结合以下附图来阅读详细说明，附图中相同的元件用相同的附图标号来表示，并且其中：
图1为用于在活体受检者心脏上执行消融手术的***的立体说明图，所述***是根据本发明的实施例构造和操作的；
图2为根据本发明实施例示出当导管移动到与心脏组织接触时，流过导管电极的电流的相位关系的复合图；并且
图3为根据本发明实施例的组织消融方法的流程图。
具体实施方式
为了能够全面了解本发明的各种原理，在以下说明中阐述了许多具体细节。然而对于本领域的技术人员将显而易见的是，并非所有这些细节始终都是实施本发明所必需的。在这种情况下，为了不使主要概念不必要地模糊，未详细示出熟知的电路、控制逻辑以及用于常规算法和进程的计算机程序指令细节。
本发明的多个方面可在软件编程代码中体现，所述软件编程代码通常被保持在永久性存储器（例如，计算机可读介质）中。在客户机/服务器环境中，这种软件编程代码可存储在客户端或服务器中。软件编程代码可在与数据处理***一起使用的多种已知非临时性介质，例如，软盘、硬盘驱动器、电子介质或CD-ROM中的任一者上体现。所述代码可分布于这类介质上，或者可经某些类型的网络从一个计算机***的存储器向其他计算机***上的存储装置分发给使用者，以便于这些其他***的使用者使用。
现在转到附图，首先参见图1，其为用于在活体受检者心脏12上执行消融手术的***10的立体说明图，所述***10是根据本发明的公开实施例构造和操作的。该***包括导管14，由操作者16将该导管14经由皮肤穿过患者的血管******到心脏12的心室或血管结构中。操作者16（通常为医师）将导管的远侧末端18在消融靶点与心壁接触。任选地，接着按照美国专利No.6,226,542和6,301,496以及共同转让的美国专利No.6,892,091中所公开的方法制备电激活图，这些专利的公开内容均以引用方式并入本文中。一种体现***10的元件的商品可以3***购自Biosense Webster,Inc.（3333Diamond Canyon Road,Diamond Bar,CA91765）。
可以通过施加热能对例如通过电活动图评价测定为异常的区域进行消融，例如，通过将射频电流通过导管中的金属线传导至远侧末端18处的一个或多个电极，这些电极将射频能量施加到心肌。能量被吸收在组织中，从而将组织加热到一定的点（通常约50℃），在该温度下组织会永久性失去其电兴奋性。此手术成功后，在心脏组织中产生非传导性的病变，这些病变可中断导致心律失常的异常电通道。本发明的原理可应用于不同的心腔室以治疗多种不同的心律失常。
导管14通常包括柄部20，在柄部上具有合适的控制器，以使操作者16能够按消融手术所需对导管的远端进行操纵、定位和定向。为了辅助操作者16，导管14的远侧部分包含方位传感器（未示出），其为处于控制台24中的定位处理器22提供信号。
可使消融能量和电信号经由电缆34穿过位于远侧末端18处或附近的一个或多个消融电极32，在心脏12和控制台24之间来回传送。可以通过电缆34和电极32将起搏信号和其他控制信号从控制台24传送至心脏12。另外连接至控制台24的感测电极33设置在消融电极32之间，并且已连接至电缆34。
电线接头35将控制台24与体表电极30和定位子***的其他部件链接在一起。电极32和体表电极30可以用于在消融点测量组织阻抗，如授予Govari等人的美国专利No.7,536,218中所提出的那样，该专利以引用方式并入本文。温度传感器（未示出），通常为热电偶或热敏电阻器，可安装在电极32的每一个上或附近。
控制台24通常包括一个或多个消融功率发生器25。导管14适于利用任何已知的消融技术将消融能量传导到心脏，例如，射频能量、超声能量和激光产生的光能。共同转让的美国专利No.6,814,733、No.6,997,924和No.7,156,816中公开了此类方法，这些专利以引用方式并入本文。
定位处理器22为***10的定位***26的元件，其测量导管14的位置和取向坐标。
在一个实施例中，定位***26包括磁性定位跟踪装置，所述磁性定位跟踪装置通过在其附近产生预定工作量的磁场并且利用场产生线圈28感测导管处的这些磁场来测定该导管14的位置和取向，并且可包括阻抗测量，如例如美国专利申请公布No.2007/0060832中所提出的那样，该专利申请以引用方式并入本文。定位***26可通过采用上述美国专利No.7,536,218中描述的阻抗测量的位置测量法而得到增强。
如上所述，导管14连接到控制台24，该控制台使得操作者16能够观察并调控导管14的功能。控制台24包括处理器，优选为具有适当信号处理电路的计算机。所述处理器被连接以驱动监视器29。信号处理电路通常接收、放大、过滤并数字化来自导管14的信号，这些信号包括上述传感器和位于导管14内远侧的多个位置感测电极（未示出）所产生的信号。控制台24和定位***26接收并使用数字化的信号，以计算导管14的位置和取向，并分析来自电极的电信号。
通常，***10包括其他部件，但为了简洁起见未在图中示出这些部件。例如，***10可包括心电图(ECG)监视器，其被附连以接收来自一个或多个体表电极的信号，以便为控制台24提供ECG同步信号。如上所述，***10通常还包括基准位置传感器，其或者位于连接到受检者身体外部的外部施加基准补片上，或者位于***到心脏12内并相对于心脏12保持在固定位置的内置导管上。提供了用于使液体循环穿过导管14以冷却消融部位的常规泵和管路。
本发明的实施例测量导管电极与体表电极之间的阻抗的相位。随着导管电极与组织之间的距离在约1-2mm的范围变化，由于电极与组织之间的电容伴随变化，该相位在接触与非接触之间显著偏移。因此，它提供了小范围距离与接触的灵敏测量。
现在参考图2，该图为根据本发明的实施例示出当导管14移动到与心脏12（图1）的壁37接触时，流过导管14的电极的电流的相位关系的复合图。出于此目的任选地提供参考电极39。参考电极39不接触壁37。以已知频率的信号驱动电极，该信号通过组织并被体表电极30（图1）或一些其他接收电极接收。图2右侧的波形从上至下包括：从参考电极39得到的参考波形41，从消融电极32得到的接触前波形43，该波形在消融电极32与壁37不接触时获取，当消融电极32与壁37机械接触时获取的接触波形45，以及消融治疗完成后但消融电极32仍与壁37接触时的消融后波形47。
相移通过垂直线49、51的位移来指示，垂直线49、51通过接触前波形43和接触波形45的对应最高点绘制。将消融电极32与壁37接触时发生相移。本发明人已发现，这类相位测量不仅可用于验证组织接触，还可用于检查消融的进程：当产生病变并且消融电极32保持与组织接触时，消融电极32与组织之间的阻抗的相位发生变化。作为另外一种选择，消融电极32与组织之间的相位变化可通过上述美国专利申请公布No.2008/0288038和2008/0275465中描述的其他相位测定方法中的任何一种测定。接近消融后波形47的波形的外观给出组织已被消融的指示。
消融期间，可以使用位置传感器结合定位处理器22（图1）确认消融电极32与壁37之间的持久接触，或通过上述其他技术的任何一种来验证电极与靶组织的物理接触。
应该指出的是，从参考电极39接收的信号的相位基本上不随末端电极与组织接触而变化。因此，参考电极39可用作测量流过消融电极32或另一个末端电极（未示出）的电流的相移的基础。消融器可在运行的同时监视相移。这两项操作不必交错进行。
现在参见图3，该图为根据本发明实施例的组织消融方法的流程图。在初始步骤53中，使用定位***26（图1）将根据上述实施例中的一个所构造的导管引入心脏中，并且将消融电极与其相关温度传感器一起定位在靶点附近。
接下来，在步骤55中，读取读数以获得接触前波形的相位。这可通过以校正模式运行消融电极32（图2）来实现。任选地，接触前波形的相位与从参考电极读取的波形相关。在任何一种情况下，均记录结果。
接下来，在步骤57中，使用上述方法中的任何一种来验证消融电极32与壁37之间的机械接触。
接下来，在步骤59中，获得并记录基线接触波形。
接下来，在步骤61中，激活消融电极以消融靶组织。
接下来，在步骤63中，在可能根据期望的病变和操作者的判断而变化的间隔后，获得术中波形并确定其相对于基线接触波形或参考波形的相位角。术中波形的相位角和计算出的预期病变的完成度的估值可显示给操作者。当相位角的变化率趋于零时，可以推断，组织中不再发生变化并且消融基本完成。
通常，根据测量的稳定性，每隔几秒（例如每2-5秒）测定一次相位角。
如果消融器空闲，则获得相位角读数的功率要求小于10毫瓦。如果消融器激活，则需要5-50瓦。
现在控制器继续至决定步骤65，该步骤测定是否已满足终止准则。可能适用的终止准则为，例如：
(1)相位角在一段时间间隔内未改变；
(2)术中波形的相位角变回至接触前波形的相位角；并且
(3)与前述包括步骤61、63的反复循环中获得的术中波形相比，相位角的偏移未超过阈值，例如50%。
如果在决定步骤65处未满足终止准则，则控制器返回至步骤61。否则控制器继续至最终步骤67，该程序在该步骤中终止。
本领域的技术人员会认识到，本发明并不限于在上文中具体示出和描述的内容。更确切地说，本发明的范围包括上文所述各种特征的组合与子组合，以及这些特征的不在现有技术范围内的变化和修改形式，这些变化和修改形式是本领域技术人员在阅读上述说明后可想到的。

Claims (9)

1.一种消融设备，包括：
柔性导管，所述柔性导管适于***活体受检者的心脏中并且具有远侧设置的消融电极以接触所述心脏中的靶组织；
消融器，所述消融器将一定剂量的能量施加到所述靶组织以便对所述靶组织进行消融；
阻抗测量子***，所述阻抗测量子***包括将被附连到所述受检者的体表电极，具有用于使电流流过所述体表电极与所述消融电极之间的第一电路以及用于测定所述电流的相位的第二电路；
用于对所述电流的相移进行反复术中测定的第三电路；和
链接到所述第三电路的监视器，所述监视器运行时显示所述消融器运行期间的所述相移的视觉指示。
2.根据权利要求1所述的设备，其中所述视觉指示包括使用所述消融器相对于所述靶组织中的预期病变的消融手术的进程。
3.根据权利要求1所述的设备，还包括用于通过所述术中测定来测定已满足了终止准则的第四电路。
4.根据权利要求3所述的设备，其中进行所述术中测定包括与得自所述消融电极的所述电流的所述相位的接触前测定进行比较，并且其中所述终止准则包括小于预定值的、所述术中测定中的一次测定与所述接触前测定之间的差值。
5.根据权利要求3所述的设备，其中所述终止准则包括所述术中测定中的一次测定与所述术中测定中的前一次测定的变化未超过阈值。
6.根据权利要求1所述的设备，其中进行所述术中测定包括与从参考电极得到的参考波形的相应相位进行比较，所述参考电极与所述靶组织间隔开。
7.根据权利要求1所述的设备，其中进行术中测定的步骤和施加一定剂量的能量的步骤同时进行。
8.根据权利要求1所述的设备，其中进行接触前测定在小于10毫瓦的功率下执行。
9.根据权利要求1所述的设备，其中进行术中测定在5-50瓦的功率下执行。
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US9687289B2 (en) 2017-06-27
CA2798973A1 (en) 2013-07-04
CN103190951A (zh) 2013-07-10
EP2612612A1 (en) 2013-07-10
AU2013200007B2 (en) 2016-03-03
JP2013138863A (ja) 2013-07-18
ES2749663T3 (es) 2020-03-23
AU2013200007A1 (en) 2013-07-18
US20130172875A1 (en) 2013-07-04
JP6095979B2 (ja) 2017-03-15
EP2612612B1 (en) 2019-07-17

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