CN102811677B - 可变输出射频消融电源 - Google Patents
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Abstract
提供一种医疗系统，包括具有至少一个消融元件和传感器的消融系统，可运行以将射频消融能量递送到消融元件的发生器。电源定义占空比并提供到发生器的电压，且电源具有占空比调节器和调幅器。处理器连接到电源、发生器、以及传感器。处理器获得来自传感器的反馈信号并根据反馈信号调节占空比调节器和调幅器。
Description
发明领域
本发明总地涉及医疗系统及其使用方法，且更具体地涉及具有可变输出电源的消融系统。
发明背景
对于诸如消融、血管成形术、扩张或类似治疗的各种处理可进行涉及导管或其它最小侵入装置的多种过程。例如，有不同原因的心律失常的多种变化，包括房颤，通常涉及通过心脏的电脉冲传递的不规则性。为了治疗心律失常或不规律心跳，外科医师通常采用专用消融导管来获得到患者身体内部区域的通路。这些导管包括末梢电极或其它消融元件以形成消融创口，消融创口生理上改变消融的组织而不将其去除、中断或阻塞穿过目标组织的点路径。在心律失常的治疗中，首先定位心脏组织诸如例如心房转子的具有不规律的电脉冲的异常导电通路的特定区域。医生（诸如外科医生）可将导管引导穿过包括例如血管的身体通路到所要治疗的心脏的内部区域。随后，选定的装置的消融部分靠近所要消融的目标放置，诸如例如肺静脉口或心房。
消融手术可能涉及形成一个或多个损伤以电绝缘相信为心律不齐的根源的组织。在该手术的过程中，外科医生可能进行例如射频（RF）消融，其包括诊断异常组织并通过射频能量的局部管理来摧毁该异常组织。可通过对与所要消融的组织接触的一个或多个电极提供RF电信号且能量电阻式地加热周围组织来进行RF消融。最后，加热工艺摧毁围绕电极的所选定的细胞，并完成消融。
在RF消融能量的递送过程中，靠近选定消融位置的局部状态可能会变化，例如由于血液和可能的生理盐水溶液的流体流动。这些流体可能是导电的，且在消融能量递送到电极的过程中，局部流体流动可能会改变电极的阻抗。根据医疗系统的具体构造，在消融手术过程中，患者的靠近消融电极的人体和体液、阻抗特性可能会在少量ohm至超过200ohm的量范围内变化。
在局部状态的显著变化可能导致诸如例如某些不想要的组织消融、局部蒸汽产生、或过加热的结果。由此在治疗过程中可能会有人体中的给定变化和组织治疗环境中的同时变化的可能性和这种变化的潜在效果，因此希望提供一种安全且有效的医疗消融系统，该系统具有反馈机构，该反馈机构自动地且连续地调节用于消融所希望治疗的组织的消融能量。还希望提供一种控制消融的表面区域和深度的消融系统和方法，且一旦完成所想要的治疗，则消融系统和方法自动地停止消融。
发明概述
本发明有利地提供一种用于通过消融预选定组织来治疗患者的医疗系统，通过使用发生器、具有至少一个消融元件的导管、患者返回电极、以及反馈系统以改变和监控发生器和患者返回电极之间的电连接以及患者返回电极与患者的接触。
具体来说，提供一种医疗系统，包括：导管，该导管具有消融元件和传感器；连接到导管的发生器，该发生器可运行以将射频消融能量递送到消融元件；电源，该电源定义占空比(duty cycle)并提供到发生器的电压，且该电源具有占空比调节器和调幅器；以及处理器，该处理器连接到电源、发生器、以及传感器；其中，处理器可运行以获得来自传感器的反馈信号并根据反馈信号调节占空比调节器和调幅器。
还提供一种医疗系统，包括：导管，该导管具有消融元件和传感器；连接到导管的发生器，该发生器可运行以将射频消融能量递送到消融元件；电源，该电源定义占空比并提供到发生器的电压；比例-积分-微分控制器，该比例-积分-微分控制器调节占空比；连接到传感器的平行电阻器的可变电阻阵列，以及连接到每个电阻器的开关；该可变电阻阵列可操作以调节电压的幅值；处理器，该处理器连接到电源、发生器、以及可变电阻阵列；其中，处理器可运行以获得来自传感器的反馈信号并根据反馈信号调节占空比和幅值。
提供一种用于治疗患者的方法，包括：提供具有电源、发生器、消融元件、以及传感器的消融系统；确定所要求的参数值；运行电源以定义占空比和输出电压；靠近治疗位置放置消融元件和传感器；将电力从电源递送到发生器；将消融能量从发生器递送到消融元件；用传感器测量参数；将测量到的参数与所要求的参数值对比以确定比较值；以及调节占空比和输出电压以最小化比较值。
附图的简要说明
通过参照结合附图考虑的下面详细的说明书，将更完整理解本发明，以及将更容易地理解本发明的其他优点和特征，附图中：
图1是根据本发明的原理的医疗系统的示意图；
图2是根据本发明的原理的用于图1的医疗系统的可变输出电源的电路框图的示意图；
图3是根据本发明的原理的具有其他部件的可变输出电源的电路框图的示意图；
图4是根据本发明的原理的具有其他部件的可变输出电源的电路框图的示意图；
图5是根据本发明的原理的医疗装置的示意图；
图6是根据本发明的原理的图5的治疗组件的示意图；
图7是根据本发明的原理的另一医疗装置的示意图；
图8是根据本发明的原理的用于图6的医疗装置的治疗组件的立体示意图；
图9是根据本发明的原理的图8的治疗组件的示意图；
图10是根据本发明的原理的另一治疗组件的示意图；
图11是根据本发明的原理的另一治疗组件的示意图；以及
图12是根据本发明的原理的流程图。
发明详述
本发明有利地提供了一种用于通过进行消融手术治疗患者的医疗系统和方法，其中，反馈机构可自动地且连续地调节消融能量以安全且有效地消融所希望处理的组织。具体来说并如图1所示，提供总体以10标记的消融治疗系统用于治疗不想要的组织状态，包括例如房颤或其他心律不齐。消融治疗系统10总体上可包括可操作地联接到诸如例如射频（“RF”）发生器14的发电机的电源12，可操作地联接到RF发生器14的心电图（“ECG”）单元16，以及医疗装置18。
医疗装置18可包括用于进行各种医疗处理的导管，导管包括例如可操作地联接到RF发生器14和ECG单元16的电生理学导管。医疗装置18可具有达到各治疗位置的形状和尺寸，诸如到血管解剖体的管腔通路，包括例如到患者的心脏的左心房跨室间隔通路以后续处理或消融。医疗装置18可大致限定细长柔性导管本体20，本体20具有远端治疗组件22,以及在导管本体20的近端处或附近的手柄组件24。
远端治疗组件22可例如包括诸如电极26的一个或多个消融元件和诸如热电偶28的一个或多个传感器。每个电极26可电联接到RF发生器14的输出部，而每个热电偶28可电联接到RF发生器14的反馈部。当然，传感器可以是任何类型，包括例如导电率传感器、分光计、压力传感器、流体流量传感器、pH传感器、以及热传感器。电源12可接受输入电压并产生输出电压到RF发生器14，其又将射频消融能量递送到消融电极26。在电极26处所获得的热能然后可通过热电偶28校验并连续监控，热电偶将反馈信号发送回处理器30，处理器30连接到电源12,、发生器14、以及热电偶28。
还可设置患者返回电极32，且患者返回电极32可包括具有比电极26更大表面面积的导电盘。患者返回电极26可在患者外部，例如通过附连到患者后背的粘接剂与患者皮肤接触，并可以可操作地联接到ECG单元16和/或直接联接到RF发生器14。
消融治疗系统10可具有一个或多个工作模式，包括例如：（i）在患者体内在医疗装置18上的治疗组件22的至少两个电极26之间递送消融能量的双极消融，（ii）在患者体内将消融能量递送到在医疗装置18上的远端治疗组件22的一个电极26并通过患者返回与患者皮肤接触的电极32的单极消融，以及（iii）双极和单极模式的组合。
RF发生器14还可包括用户界面34，用户界面34可包括显示器和/或远程控制36，用户界面使得用户能够选择所需定位和/或消融治疗的参数。用户界面34可允许用户选择治疗的能量递送模式，诸如例如在仅单极能量、仅双极能量、或两者的组合的递送之间选择。当在组合模式时，用户界面34还可允许选择单极能量与双极能量的功率比，诸如1:1、2:1、或4:1。RF发生器14可默认提供一组特定能量比，使得用户可选择已建立的能量比之一，和/或用户界面可允许用户输入不同的定制能量比。用户界面34还可允许在导管变化时，或当医疗装置18移动到不同的位置以消融不同的组织时改变能量模式。
ECG单元16还可具有ECG监控单元或显示器38以监控和定位由医疗装置18的远端治疗组件22的电极26检测的信号。RF发生器14和ECG单元16可同时可操作地联接到医疗装置18。ECG单元16可设计成将其自身和显示器38与由RF发生器14产生的信号电绝缘，这可包括与可能来自RF发生器14的大幅值信号和电噪声绝缘。
电源12可以使具有定义占空比的降压型转换器的开关模式电源并可具有反馈机构以调节输出电压，包括例如占空比调节器和调幅器。根据此时的运行模式，电源12确定消融元件附近的局部状态所要求的参数。所需的参考可例如是所要求的温度，且可以称为“设定点”。
反馈机构获得来自消融元件附近的传感器的反馈信号，将该反馈信号与设定点比较并计算所要求的设定点与反馈信号之间的差异，以获得比较值。
占空比调节器反馈机构可以是比例-积分-微分（PID）控制器40，控制器40使用处理器算法以通过调节电源占空比来最小化比较值。PID控制器40可采取处理器30的电路的子集形式，或任何其他合适的布置，包括例如软件子程序或单独的控制单元。运行中，PID控制器40基于当前的比较值计算比例项、基于近期比较值之和计算积分项、以及基于比较值变化的速率计算微分值项。电源占空比然后通过PID控制器40调节以调节到RF发生器14的电源输出电压并控制消融。
图2示出用于图1所示的医疗消融系统的可变输出电源12的电路图。电源12可包括降压型转换器42，转换器42具有输入电压44并基于来自传感器（诸如例如热电偶28）的反馈信号产生输出电压46，并然后根据反馈信号调节占空比调节器和调幅器。降压型转换器42可包括呈积分电路形式的校准器或处理器48，诸如例如市场上可提供的积分电路LTC 1775。降压型转换器42的具体实例进行直流（DC）输入电压到DC输出电压的可变降低电压转换。输入电压44可在合适量的范围内选择，诸如例如等于或小于20伏DC的电压，包括约4.7伏的更具体实例。处理器48可与诸如例如感应器50、电容器52、电阻器54、以及可变电阻56的多个部件组合。
图3示出具有降压型转换器58的通过PID控制器来调节占空比的可变输出电源的更具体实例，其中，与图2中那些相同的附图标记来标示输入电压44、输出电压46、感应器50、电容器52、电阻器54、以及可变电阻56。校准器或处理器60比图2的处理器48更复杂，且增加其他部件，包括例如附加的电阻器62、二极管64、和电容器66。附加的电阻器62可例如用于将到处理器60的输入电压提升到大于输入电压44，这可提高电源的总体效率。二极管64可以是常规二极管，或作为更具体的实例可以是肖特基（Schottky）二极管，并可工作以给电容器充电，该电容器为可变电阻56内部的场效应晶体管（FET）供电。电容器66可辅助控制输入处的均方根（RMS）电流，并避免在输出46处波动。
图4示出具有更详细细节的可变输出电源68，且其增加了用于调幅的可变电阻阵列。例如，处理器70接受输入电压72并基于来自例如热电偶28的传感器的反馈信号产生输出电压74，并然后根据反馈信号调节占空比调节器以及调幅器。具体来说，感应器76、电容器78、以及电阻器80以类似于图2中的那些的方式进行，且电路包括诸如例如电阻器82、二极管84、电容器86、以及晶体管88的附加部件。这些附加部件可选择成具有各种适当的特性。更具体来说，晶体管的具体类型可以是金属氧化物半导体场效应晶体管。
调幅器反馈机构可以是可操作地联接在处理器70与热电偶28之间的可变电阻阵列90。可变电阻阵列90具有多个平行电阻器92A-H，每个电阻器92A-H与FET联接，FET组合了二极管94A-H和晶体管96A-H的特征。基于来自热电偶28的反馈信号，处理器30可致动晶体管96之一以允许电流流过相应的电阻器94并由此调节占空比的幅值。
图4所示的具体实例中，示出8个平行的电阻器92A-H，但可选择任何合适数量的平行电阻器。而且，每个平行电阻器92可选择成具有不同电阻，且在一具体实例中，它们可具有如下电阻值（单位为ohm）序列：1024k、512k、256k、128k、64k、32k、16k、以及8k。当然，可选择任何合适种类的平行电阻。
现参照图5-11，示出某些示例性医疗装置。具体来说，图5示出具有远端治疗组件102的消融导管100，其中电极26具有线性构造。远端治疗组件102可用于在远端治疗组件102的电极26之间的双极消融，或用于在一个电极26与患者返回电极32之间的单极消融，或双极消融和单极消融的组合。近端手柄104具有用于操纵、弯曲、转向和/或将远端治疗组件102重塑成各种所要求形状，曲线等的转动致动器106。图6更详细地示出远端治疗组件102，包括电极26和热电偶28。
图7-9示出具有远端治疗组件110的消融导管108，其中电极具有平面构造。类似于消融导管100，远端治疗组件110可用于双极消融、单极消融、及其组合。近端手柄112具有用于操作消融导管108的远端部分的转动致动器114、以及线性致动器116线性致动器116可向远端前进远端治疗组件110超出导管轴，并向近端将远端治疗组件110缩回在导管轴内部。当远端治疗组件110向远端前进时，其可从在导管轴内部的压缩布置弹性膨胀到图8和9所示的展开布置。
图10示出具有远端治疗组件120的导管118，远端治疗组件120具有弹性框架，其中电极具有朝近端导向的构造，这可例如用于患者心脏的跨室间隔治疗。
图11示出具有远端治疗组件124的导管122，其中电极具有可调整线性、平面、或螺旋构造。
相应地，医疗装置18可用于观察并处理选定组织区域中（诸如心脏中）的异常电脉冲或信号。首先，远端治疗组件22可经由股动脉在先前插入的导线上前进穿过患者的脉管系统。远端治疗组件22然后可例如前进入右心房并进入肺静脉的近端。
相应地，医疗装置18可用于观察并处理选定组织区域中（诸如心脏中）的异常电脉冲或信号。首先，远端治疗组件22可经由股动脉在先前插入的导线上前进穿过患者的脉管系统。远端治疗组件22然后可例如前进入右心房并进入肺静脉的近端。
如图12的流程图中所示，在本系统的示例性使用中，首先准备用于消融的医疗系统，并设定消融系统（步骤200）。放置一个或多个患者返回电极（步骤202），并放置消融导管，从而具有电极和传感器的远端治疗组件位于治疗所要求的位置（步骤204）。确定各种消融参数，包括消融预期的持续时间（步骤206）。选择所要求的消融模式，例如单极消融、双极消融、或其特定组合，并确定期望的反馈参照值（步骤208）。例如，如果传感器是热传感器，那么期望的反馈参数值可选择在局部状态下液体沸点温度（其可以是100摄氏度）下方的温度。
如果所有的参数都不可接受（步骤210），那么评估并纠正步骤和参数（步骤212）。如果所有的参数都可接受，那么可着手消融能量的递送。运行电源，定义提供输出电压到发生器的占空比（步骤214），以及消融能量从发生器递送到电极（步骤216）。
在消融过程中，连续测量反馈参数（步骤218），并将测量到的反馈参数与期望的反馈参数对比以确定比较值（步骤220）。独立地调节占空比和幅值以最小化比较值（步骤222）。当完成消融时（步骤224），消融系统停止递送能量（步骤224）。
虽然已经提供了具体医疗系统构造的实例和说明，但应理解，各种布置、形状、构造、和/或尺寸可包含在本发明的医疗装置中，包括但不限于本文所示和所描述的那些。而且，虽然单极和双极RF消融能量可以是选定的穿过医疗装置的电极的能量形式，但是，其他形式的消融能量可以附加地或替代地从治疗组件发出，包括电能、磁能、微波能、热能（包括热和低温学能量）及其组合。此外，可应用的其他形式能量可包括声波能量、声能、化学能、光能、机械能、物理能、辐射能及其组合。
本领域的技术人员将理解本发明不限于本文上面已经具体示出和描述的内容。而且，除非与上面提到相反，应注意，所有的附图不是按比例的。根据上面的教导，各种改型和变型是可能的而不脱离仅由下面权利要求书所限定的本发明的范围和精神。
Claims (8)
1.一种医疗系统，包括：
导管，所述导管具有消融元件和联接到所述消融元件的热传感器；
连接到所述消融元件的射频发生器；
电源，所述电源定义占空比并向所述发生器提供电压，且所述电源具有占空比调节器和调幅器；以及
处理器，所述处理器连接到所述电源、所述发生器、以及所述传感器，所述调幅器还包括与所述传感器和所述处理器通信的可变电阻；
其中，所述处理器运行以获得来自所述传感器的温度反馈信号,并根据所述温度反馈信号调节所述占空比调节器和所述调幅器；以及
其中，所述可变电阻还包括多个平行电阻器，每个电阻器具有不同的以欧姆测定的电阻；所述处理器允许电流流过一个或多个平行电阻器以调节所述调幅器。
2.如权利要求1所述的医疗系统，其特征在于：所述处理器运行以响应所述反馈信号调节所述可变电阻。
3.如权利要求1所述的医疗系统，其特征在于：还包括连接到每个平行电阻器中的二极管和晶体管；所述处理器通过选择和致动相对应的晶体管而允许电流穿过一个或多个平行电阻器。
4.如权利要求1所述的医疗系统，其特征在于：每个晶体管是金属氧化物半导体场效应晶体管。
5.如权利要求1所述的医疗系统，其特征在于：所述占空比调节器还包括比例-积分-微分控制器。
6.如权利要求1所述的医疗系统，其特征在于：所述电源还包括降压型转换器。
7.如权利要求1所述的医疗系统，其特征在于：所述消融元件是至少一个电极。
8.如权利要求1所述的医疗系统，其特征在于：所述传感器靠近所述消融元件。
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| US9155590B2 (en) | 2015-10-13 |
| EP2542173A1 (en) | 2013-01-09 |
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| US20140012253A1 (en) | 2014-01-09 |
| CN102811677A (zh) | 2012-12-05 |
| WO2011109141A1 (en) | 2011-09-09 |
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