CN104684500B - 用于消融和电穿孔组织细胞的设备 - Google Patents
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- A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
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- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
- A61B2018/1467—Probes or electrodes therefor using more than two electrodes on a single probe
Abstract
一种医疗系统，该医疗系统具有医疗设备和配置为使用该医疗设备来治疗目标组织细胞的计算机，该医疗设备被配置成选择性地在发生组织电穿孔的电压下、在发生热消融的电压下、在发生组织电穿孔的电压与发生热消融的电压之间的电压下传递能量。
Description
技术领域
本发明涉及一种用于使用组合的热量和电穿孔来产生更深度损伤同时避免在组织表面产生过多热量的高压射频消融的方法和系统。
背景技术
对于如增强化疗（电化学疗法）、细胞消融、和细胞内电操纵的这样的目的，电场的使用是相对较新的药物治疗。所有三种治疗都涉及能量的脉冲，尽管使用不同的频率和脉冲持续时间。当细胞暴露于高电压电场脉冲时，发生诸如肿瘤或肝细胞的消融。在存在这些脉冲的情况下，整个细胞膜上的电化学电势被改变并且诱发偏振脂质双分子层中的不稳定性，此举可导致在细胞膜中的不可逆的孔的形成（或现有的孔的扩大）。该现象可通过细胞内容物的损失或周围污染物的进入导致细胞死亡。
当暴露于电场时这种在细胞膜渗透性的增加通常被称为电穿孔，并且可以通过内部（经由，例如，导管）地或外部地应用的直流（DC）电能的脉冲的应用发生。然而，电脉冲的重复频率被认为影响肌肉收缩，此举可在患者中产生烧灼感或剧烈疼痛。
此外，有时需要深度损伤来有效地治疗某些心脏病况。例如，可通过穿过并在有疤痕的心肌组织周围的异常导电通路引起心房纤颤，此举导致电“反馈回路”和心律不齐。为了破坏这些异常通路，必须足够深地消融心肌组织以停止有问题的电信号。深度损伤的创建要求能量和/或高温的长时间的应用。然而，组织的表面必须保持在足够凉爽的温度下，以避免炭化或微栓子形成，炭化或微栓子形成可导致意想不到的组织死亡或中风。
因此，期望能够在不产生高热量且而不会引起病人不适的情况下产生深度损伤的系统和方法。本发明的系统和方法涉及应用高电压射频能量以使用热量和电穿孔来执行消融同时避免由于在组织表面处的过多热量引起的不期望的组织破坏。
发明内容
本发明有利地提供了一种用于在不产生高热量的情况下产生深度损伤的方法和系统。该方法一般地包括使用医疗设备来治疗目标组织细胞，该医疗设备被配置成选择性地传递发生组织电穿孔的电压下的能量、发生热消融的电压下的能量、或其间的任何电压下的能量。医疗设备还可被配置成将组织的温度降低至发生冷冻消融的温度。所应用的能量可以是射频（RF）能量，并且RF能量可以是具有在约20kHz至约1MHz的频率的交流能量。可在约500伏RMS和大约3000伏RMS之间传递电穿孔能量。而且，在应用发生电穿孔的电压前，将发生热消融的电压被应用至目标组织。更进一步，医疗设备可包括多个电极，并且射频能量被传递至多个电极中的每一个，传递至多个电极中的每一个的能量相对于传递至相邻电极的能量成同相角或异相角。
在另一实施例中，该方法可包括将医疗设备定位成与目标组织区域接触，医疗设备包括与射频发生器通信的多个电极，该发生器可编程成以双极模式、和单极模式与双极模式的组合中的至少一个传递能量，在约500伏RMS至约3000伏RMS之间将来自医疗设备的射频能量传递至目标组织，并在约100伏RMS至约150伏RMS之间将来自医疗设备的交流射频能量传递至目标组织的区域。该方法可进一步包括在约150伏RMS和约500伏RMS之间的电压下传递交流射频能量。传递至多个电极的每一个的能量可相对于传递至相邻电极的能量成同相角或异相角传递。
该系统可一般包括具有在设备的远端处的多个电极的医疗设备，和与多个电极通信的能量发生器，该发生器可编程成在约100伏特RMS和约3000伏特RMS之间进行传递。该设备可进一步包括在远端处的一个或多个传感器。该能量发生器能够可编程成在第一治疗周期期间在约100伏RMS和约150伏RMS之间和在第二治疗周期期间在约500伏RMS和约3000伏RMS之间进行传递。此外，能量发生器能够可编程成将以单极模式、双极模式、以及其组合中的至少一个来将能量传递至多个电极。
附图简述
在结合附图考虑时，参考以下详细描述，将更容易地了解本发明的更完整的理解以及其所附的优点和特征，其中：
图1示出根据本发明的系统的第一实施例；
图2示出根据本发明的系统的第二实施例；
图3A和3B示出具有多个电极的医疗设备的远端和当设备以单极或多极模式操作时创建的损伤；以及
图4是示出根据本发明的方法的流程图。
发明详细描述
本发明提供用于在不产生高热量且不会引起病人不适情况下产生深度损伤的系统及其使用方法。高频交流（AC）射频（RF）能量可被用于（例如，在约20kHz至约1MHz之间，由于该范围不刺激心脏，但仍然提供电泳（electroporetic）效果）通过细胞电穿孔或热量或它们的组合来消融组织，同时将组织表面温度维持在低于导致意想不到的炭化或微栓子形成的阈值温度。此外，AC RF能量的该应用没有导致在应用DC能量时的患者不适或疼痛。更进一步地，在由于热能而能消融组织的电压下、由于电穿孔效果而能消融组织的电压、或在沿热能和电穿孔能量之间的闭集（continuum）的任意点处的电压下，施加AC RF能量。现参照所附附图，其中相同的附图标记指的是相同元件，图1示出了用于生成并将高压RF能量应用至目标组织12的区域的系统10的第一实施例。系统10一般地包括医疗设备14、能量发生器16、和用于操作、监测、和调节设备14的操作的控制台18。
参照图1和2，医疗设备14可以是导管，例如，如图1所示的RF消融导管。导管14可适于用仅单一能量形式（例如，RF能量）、或能量形式的组合（例如，RF加激光、微波、冷冻消融、和/或超声能量）使用。不管导管14所适合的能量形式的数量，但是，导管14必须至少能够传输将电穿孔目标组织细胞12的电场。例如，导管14可能够在约2000V或以上的电压下传输RF能量。导管14可包括具有近端部分22和远端部分24的柔性细长本体20。细长本体20的远端24可具有固定的直径（如图1所示），或可包括可扩展的元件（如图2所示）。细长本体20可包括多个治疗元件，诸如在远端24处的用于将能量传递至目标组织12的电极26。如果除RF之外还使用第二能量形式，则除多个电极26外治疗元件还可包括热透射区域，诸如，气囊或其它可扩展元件、直接或间接暴露于冷冻流体的流动路径的金属结构、或一个或多个导热聚合物或复合物。例如，图2示出了除电极阵列26之外还具有冷冻消融球囊27的导管14。多个电极26可以是任何数量、配置、或形状，例如，多个分立电极、部分地或完全地外接于细长本体20（如图1所示）或球囊27的带状电极、纵向取向的电极（如图2所示）、尖端电极（如图2所示）、或电极的集群。电极可以是以应用至远端部分24的外表面的导电条的形式，并且可由金属、导电聚合物、导电油墨印刷或微毛细管印刷制成。电极26可被粘附地结合至设备14或由离子沉积或等离子体沉积施加。替代地，诸如银、铂、或金之类的导电材料可被掺杂或以其它方式混合到气囊27材料中。
导管14可限定用于提供在细长本体20的近端部分22和远端部分24之间的机械、电、和/或流体连通的一个或多个腔28。一个或多个腔28可被热绝缘以基本上防止在例如，内腔28（和其中的任何设备或组件）和多个电极26之间的热交换。细长本体20的远端部分24可进一步包括用于检测压力、温度、电阻抗、或其他系统和/或环境参数（例如，目标组织12的表面温度）的一个或多个传感器29。一个或多个传感器29可是任何配置（例如，如图1所示的环传感器、或如图2所示的尖端和球囊传感器），并可与控制台18通信，用户使用控制台18可控制传递至导管14的能量。例如，如果温度传感器29检测到组织12表面温度在阈值温度处或附近，则可停止能量应用（由系统10自动地或由用户手动地）和/或减少RF电压以避免意想不到的组织破坏。
细长本体20的近端部分22可耦合至手柄30，手柄30可包括，电和流体连接器、引线、接头（junction）、或管的各种端口，并且还可包括各种控制组件，诸如开关或阀，以及安全检测或关机组件。例如，手柄30可包括可通过到控制台18的一个或多个连接（umbilical）的方式直接或间接可配合的连接器。此外，手柄30还可包括用于操纵或偏转细长本体20的至少一部分的元件，诸如控制杆或旋钮。
继续参考图1和2，能量发生器16可以是能够以多种模式（诸如，单极、双极、和它们的组合）传递能量的RF能量发生器，单极和双极的组合诸如是4:1、2:1、和1:1（占空比控制的电力输送系统）。而且，发生器16能够传递约500伏RMS至约2000伏RMS或以上（例如，高达3000V）的脉冲交流（AC）RF能量。在这些较高的电压下，在电极26的温度的没有大幅增加的情况下，大部分的细胞损伤将是由于目标组织12细胞的电穿孔（例如，由于45℃以上的温度）引起的。在电穿孔期间，RF能量可在多个ON/OFF周期中传递，其中ON周期仅表示总占空比时间的约0.5％至约1％。高压能量的这些快速脉冲串在目标组织细胞的细胞膜中创建孔，但不会用热量损坏组织。因此，可在不大幅增加热能的情况下实现更深度损伤，并因此可避免对非目标组织的意想不到的损坏或组织碳化。例如，组织表面温度可被维持在低于可发生不可逆的意想不到的损坏的45℃的温度。此举继而减少了潜在的致命并发症的可能性（例如，微栓子的形成），并减少了患者不适。
发生器16还可能够在较低的电压（例如，约100至约150伏RMS）下操作以主要使用热能来消融组织。为了生成热能，可在多个ON/OFF周期中传递RF能量，其中ON周期大于，例如，总周期的2％。组织可在45℃以上的温度下被不可逆地损坏；然而，亚致死热能可被应用于暂时“击昏（stun）”（而不是不可逆地损坏）目标组织的区域，以帮助确定被击昏组织的区域是否使得有关心律失常的异常电信号持续，并且由此确定对组织的被击昏区域的后续电穿孔是否将阻碍该异常电信号。由于电穿孔可能不会导致所治疗组织的立即消融（即，在电穿孔后的一段时间内，被治疗的细胞可继续在一定程度上正常起作用）并由此导致立即的电流堵塞，因此可能难以确定是否电穿孔了正确的组织区域。因此，热能和电穿孔的组合可导致更有效且高效的消融。
发生器16可以允许选择在所有电极对上的同时或选择性能量传递，并且可进一步包括用于监测消融时间、电极温度、温度下的时间等的用户界面32。发生器16的能量输出方案可独立于控制台18经由用户界面32是可编程的。此外，发生器16可能够传递可调节的电压，因此可使用主要是热量（例如，在约100伏到约150V之间）、主要是电穿孔（例如，和在约500V和约2000V之间或以上）、或它们的任何组合（沿着热电压和电穿孔电压之间的闭集的任何位置处的电压）来引起消融。此外，发生器16可以可编程成操纵能量输出的特性，诸如，总占空比的ON周期百分比、电压、和ON/OFF序列的数量。在非限制示例中，电压可被调节成使用主要是热量、主要是电穿孔、或它们的组合来交替地消融组织12。在附加的非限制性示例中，除电穿孔（如图2所示）之外还可使用冷冻消融，在这种情况下，发生器16可将电压保持在约500至约2000伏RMS或以上以引起细胞的电穿孔，此举可补充冷冻消融。可同时或交替地使用冷冻消融和RF消融。冷冻消融所需的温度可低于消融组织正常所需的温度，因此需要更低的冷却剂流速和/或体积。更进一步，如果还使用微波、激光、或超声能量，则可使用第二发生器34。因此，用户可对治疗过程具有非常精确的控制。
继续参照图1和2，控制台18可用于在系统10的操作期间控制医疗设备14的一个或多个组件的温度。控制台18可包括电源35、与其他系统10组件（诸如，多个电极26、一个或多个传感器29、和/或发生器16）通信并具有一个或多个屏幕或显示器38的计算机36，用户可用该一个或多个屏幕或显示器38监测和/或调节系统10参数。作为附加或替代，计算机36可被编程成至少部分地基于从一个或多个传感器29接收的信号来自动地调节诸如由发生器16传递的电压、从冷却剂源40（如图2所示）传递的冷却剂体积和流量、和一个或多个治疗元件40的有效温度之类的参数。而且，可通过耦合至医疗设备14和/或与计算机36通信的一个或多个有源（active）热元件的实施来实现温度调节，诸如，一个或多个冷却元件（诸如，过冷却器、珀耳帖冷却器、焦耳-汤普森冷却器、斯特林发动机等等）和/或有源（active）热源（诸如，加热元件、浸入式加热器、循环加热器，或用于加热流体或气体的其他设备）。如果系统10被配置用于冷冻消融，则系统10可不仅包括冷却剂源40，还包括冷却剂返回储液器和真空泵，并且设备14可包括流体注入腔、流体返回腔、流体注入元件等。
现在参照图3A和3B，医疗设备14的远端部分24可包括多个电极26，并且每个电极能够与一个或多个相邻电极异相地操作。这允许设备14以单极模式、双极模式、或它们的组合操作。而且，该模式选择可与电压选择结合使用，藉此产生可能的各种的治疗效果。如图3A和3B所示，远侧部分24可包括四个电极26A、26B、26C、26D，但是可以理解，可使用对任何数量或配置的电极，诸如包括多个电极的阵列或网格。
所有四个电极可被激活以双极性模式在1000V RMS下施加能量（如图3A所示）。作为非限制性示例，电极26A可以0°在1000V下施加能量，电极26B可以与电极26A 180°异相地在1000V下施加能量，电极26C可以0°（与电极26A同相）在1000V下施加能量，以及电极26D可以与电极26C 180°异相地在1000V下施加能量。在这种情况下，在任意两个电极之间施加的能量将是由任一电极施加的电压的两倍（例如，2000V RMS）。然而，使用不同相位角将创建不同组合的电压。例如，如果电极26A和26C以0°在1000V下施加能量且电极26B和26D以90°在1000V下施加能量，在电极26A和26B（或相邻电极的任何组合）之间的组合电压将为约1400V RMS（或1000V的约1.414倍）。类似地，60°移位将导致1000V的在电极26A和26B（或相邻电极的任何组合）之间的组合电压（没有创建增加效果）。实际上，在0°和180°之间的任何相位角可用于创建在电极之间的期望的组合电压。而且，传递至目标组织的电压的量还取决于电极之间的距离。例如，如果电极26A和26B传递1000V的组合电压并且电极间隔开10mm，则电极之间的每毫米的组织将接收100伏。作为替代，电极可被激活以单极模式施加能量，其中电极之间没有相位差（如图3B所示）。因此，多电极设备14能够在以单极模式操作时创建连续损伤42或在以双极模式操作时创建离散损伤44。因此，可通过在双极性模式下的相移和（以单极模式或双极模式）传递至每个电极、计算为电极之间的距离的函数的电压来操纵施加至组织的有效电压。而且，如上所述，设备14用于使用热能、电穿孔、或它们的组合来消融组织。更进一步地，设备14可用于同时使用电穿孔和另一能量形式（诸如，冷冻消融）来消融。
现在参照图4，示出了使用电穿孔和热能的消融方法的流程图。将理解，即使冷冻消融包括将热量从组织移除，冷冻消融仍被包括在本文中作为“能量形式”。图4的方法一般地包括将医疗设备14定位在目标组织12的区域附近、确定消融目标组织12所采用的方法、激活一个或多个治疗元件、并且在必要时调节能量发生器以消融目标组织12。步骤1包括将医疗设备14定位在目标组织12的区域附近。作为非限制示例，目标组织可以是心脏（诸如，心内膜或心外膜组织）、肝脏、胰腺、肾脏、或肿瘤组织。实际上，目标组织12可以是其中电穿孔将在组织细胞膜内创建孔并且其中不可逆的电穿孔将导致细胞死亡的任何生物组织。
在图4的步骤2中，治疗元件将被放置为与目标组织12接触。例如，如果除RF能量（用于电穿孔）之外还使用冷冻消融，则球囊27和多个电极26应当被放置为与目标组织12接触。在步骤3中，确定消融目标组织12将采用的方法。例如，如果仅期望电穿孔，则发生器16可被编程成将在约500和约2000V或更高之间（例如，3000V;“电穿孔电压”）将能量传递至所有多个电极26。如果用户期望仅使用热能或冷冻消融来消融目标组织12，则发生器16可被编程成在约100至约150伏RMS（“消融电压”）之间将能量传递至所有多个电极26和/或发起的冷却剂的流。如果用户期望使用电穿孔和热能量（和/或冷冻消融）的组合来消融目标组织12，则发生器可被编程成在沿着电穿孔电压和热电压之间的闭集的任何位置处的期望电压下传递能量。可通过调节来自发生器16的输出电压或调节相邻电极之间的相位角来完成此举。或者，给一些电极26电穿孔电压，且给一些电极26消融电压。或者，由多个电极输出的电压水平和/或能量应用持续时间可被调节，从而由热量和电穿孔两者消融来组织12。因此，每个被激活的电极26可接收电穿孔电压或消融电压；一些电极可完全不接收电压（即，可能不被激活）。或者，每个激活的电极26可接收引起电穿孔和电消融两者的电压。而且，发生器16可被编程成向所有电极26传递热电压、然后传递电穿孔电压，诸如当用热能测试组织的区域来确定该组织的电穿孔是否将有效地阻碍异常电流时。因此，发生器16可被编程成按需向多个电极26传递热能、电穿孔能量、或它们的任何组合（步骤4A和4B）。更进一步地，发生器16可被编程成以单极模式、双极模式、或它们的组合来传递能量。
在图4的步骤5中，可监测系统10和组织12参数。在消融期间，一个或多个传感器29（诸如，温度传感器）可测量组织表面的温度。如果温度传感器检测到高于阈值温度（例如，45℃）的组织温度，则系统10可由用户手动地调节，或能量发生器16和/或计算机36可被编程成自动地调节电压、冷却剂流量、治疗元件的有效温度、和/或其他系统10参数，以确保不会发生非预期的组织破坏（步骤6）。此外，医疗设备14可包括一个或多个电导率传感器，其可提供映射功能和/或检测目标组织12的状态。例如，至少部分地基于电导率测量，用户和/系统10可确定目标组织12是否已被消融（步骤6B）。如果目标组织12未被满意地消融，则系统10可同样由用户手动地调节，或能量发生器16和/或计算机36可被编程成自动地调节电压、冷却剂流量、治疗元件的有效温度，和/或其他系统10参数，以确保目标组织12的完全消融（步骤6）。
在完成步骤1-6之后，目标组织12被消融。在图4的步骤7中，可从目标组织12的区域移除导管14。
本领域技术人员应当理解，本发明不限于在上文中已具体示出并描述的内容。另外，除非作出相反提及，应该注意所有附图都不是按比例的。在不背离本发明范围和精神的情况下根据以上示教可能有各种修改和变型，本发明只受所附权利要求书限制。
Claims (7)
1.一种医疗系统，包括：
医疗设备，包括多个电极；
计算机，所述计算机被配置成使用所述医疗设备来治疗目标组织细胞，所述医疗设备被配置成选择性地在如下电压下传递脉冲交流能量：
(a)发生组织电穿孔的电压，该电压在500伏RMS至2000伏RMS之间，
(b)亚致死热消融电压，组织在该电压下被临时击昏，以及
(c)发生组织电穿孔的电压与组织被临时击昏的电压之间的电压；
所述计算机被配置成将射频能量传递至所述多个电极的每一个，传递至所述多个电极的每一个的能量相对于传递至相邻电极的能量成同相角和异相角中的至少一个。
2.如权利要求1所述的系统，其特征在于，所述医疗设备进一步被配置成将所述组织细胞的温度降低至发生冷冻消融的温度。
3.如权利要求1所述的系统，其特征在于，所述能量是交流射频能量。
4.如权利要求3所述的系统，其特征在于，所述电穿孔是不可逆的。
5.如权利要求4所述的系统，其特征在于，所述射频能量具有在约20kHz和约1MHz之间的频率。
6.如权利要求1所述的系统，其特征在于，所述消融能量是如下项中至少一个：激光能量、超声能量、射频能量、微波能量、和热能。
7.如权利要求1所述的系统，其特征在于，所述计算机被配置为在施加发生电穿孔的电压前，向目标组织细胞施加发生热消融的电压。
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2012
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2013
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- 2013-08-27 CN CN201380046575.0A patent/CN104684500B/zh active Active
- 2013-08-27 WO PCT/US2013/056756 patent/WO2014039320A1/en active Application Filing
- 2013-08-27 EP EP13759636.7A patent/EP2892455B1/en active Active
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| EP2892455A1 (en) | 2015-07-15 |
| US9113911B2 (en) | 2015-08-25 |
| CA2882960A1 (en) | 2014-03-13 |
| WO2014039320A1 (en) | 2014-03-13 |
| CA2882960C (en) | 2018-09-04 |
| EP2892455B1 (en) | 2017-06-28 |
| US20140066913A1 (en) | 2014-03-06 |
| CN104684500A (zh) | 2015-06-03 |
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