CN104337567A - 用于操作电外科发生器的系统和方法 - Google Patents
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Abstract
本发明涉及用于操作电外科发生器的系统和方法。根据本公开的实施例的系统和方法在电外科程序期间提供最佳组织效应。提供一种用于控制电外科发生器的系统和方法，其包括：感测靶组织的阻抗；在第一相位中以第一功率水平生成电外科能量直到靶组织的被感测阻抗大于第一阈值阻抗；在第二相位中以第二功率水平生成电外科能量的多个脉冲，每个脉冲被生成直到靶组织的被感测阻抗大于针对该脉冲设置的第二阈值阻抗；以及在第三相位中以第三功率水平生成至少一个高电压脉冲持续预定持续时间以分割靶组织。
Description
技术领域
本公开涉及用于操作电外科发生器的系统和方法。更特别地，本公开涉及用于控制电外科发生器的输出以便优化组织的切割的系统和方法。
背景技术
电外科手术包括将高射频电流施加到手术部位以切割、消融或凝固组织。在单极电外科手术中，源或有源电极将来自电外科发生器的射频交流电流输送到靶组织并且返回电极将交流电流传导回到发生器。患者返回电极远离有源电极放置以将电流传导回到发生器。
在双极电外科手术中，返回和有源电极彼此紧靠地放置使得在两个电极(例如，在电外科钳的情况下)之间形成电路。以该方式，施加的交流电流被限制到位于电极之间的身体组织。因此，双极电外科手术通常包括器械的使用，其中期望获得定位在器械(例如钳等)上的两个电极之间的电外科能量的聚焦输送。钳是钳状器械，依赖于它的钳夹之间的机械动作来抓紧、夹紧和限制血管或组织。电外科钳(开放式或内窥镜)使用机械夹紧动作和电能来实现夹紧组织的止血。钳包括将电外科能量施加到夹紧组织的电外科导电表面。通过控制通过导电板施加到组织的电外科能量的强度、频率和持续时间，外科医生可以凝固、闭合和/或切割组织。然而，以上示例仅仅用于示例性目的并且在本公开的范围内可以有许多其它已知的双极电外科器械。
发明内容
根据本公开的实施例的系统和方法在电外科程序期间提供最佳组织效应。根据一个实施例，本公开提供用于控制电外科发生器的方法。
根据本公开的各方面，提供一种用于控制电外科发生器的方法，其包括：感测靶组织的阻抗；在第一相位中以第一功率水平生成电外科能量直到靶组织的被感测阻抗大于第一阈值阻抗；在第二相位中以第二功率水平生成电外科能量的多个脉冲，每个脉冲被生成直到靶组织的被感测阻抗大于针对该脉冲设置的第二阈值阻抗；以及在第三相位中以第三功率水平生成至少一个高电压脉冲持续预定持续时间以分割靶组织。
在本公开的一些方面中，所述方法还包括在阻抗感测相位中以第四功率水平生成电外科能量以感测靶组织的初始组织阻抗。
在本公开的一些方面中，所述第一阈值阻抗等于高于所述初始组织阻抗的预定阻抗升高量。
在本公开的一些方面中，所述第二阈值阻抗等于高于所述初始组织阻抗的可调节阻抗升高量。
在本公开的一些方面中，所述可调节阻抗升高量是针对每个相继脉冲基于调节因数增加、减小和保持相同中的至少一种。
在本公开的一些方面中，针对每个相继脉冲所述可调节阻抗升高量乘以所述调节因数。
在本公开的一些方面中，所述第二相位中的脉冲被施加直到被感测组织阻抗大于最大阈值阻抗值。
在本公开的一些方面中，所述方法还包括基于靶组织的被感测初始阻抗确定靶组织的组织类型；以及在所述第三相位期间基于被确定组织类型生成多个高电压脉冲。
在本公开的一些方面中，如果靶组织的被感测初始阻抗小于组织类型阈值阻抗值，则组织类型被确定为低阻抗组织类型并且在所述第三相位期间输送的高电压脉冲的数量被设置为第一值，并且如果靶组织的被感测初始阻抗大于或等于组织类型阈值阻抗值，则组织类型被确定为高阻抗组织类型并且在所述第三相位期间输送的高电压脉冲的数量被设置为第二值，所述第二值大于所述第一值。
在本公开的一些方面中，所述方法还包括如果靶组织的被感测阻抗超过最大阈值阻抗值则在所述第三相位期间停止生成至少一个高电压脉冲。
在本公开的一些方面中，所述方法还包括如果至少一个高电压脉冲的电压和电流的相位差大于预定相位差值则停止在所述第三相位期间生成所述至少一个高电压脉冲。
在本公开的一些方面中，在所述第二相位中的多个脉冲中的每个脉冲之后将所述发生器设置为具有第五功率水平的关闭状态持续预定持续时间，所述预定持续时间被设置成使得在所述多个脉冲中的每个脉冲之后靶组织至少部分地再水化。
在本公开的一些方面中，在所述第三相位中的至少一个高电压脉冲的每个脉冲之后将所述发生器设置为具有第五功率水平的关闭状态持续预定持续时间，所述预定持续时间被设置成使得在每个脉冲之后靶组织至少部分地再水化。
在本公开的一些方面中，在所述第一、第二和第三相位中生成的每个脉冲之后将所述发生器设置为具有第五功率水平的关闭状态，每个关闭状态具有预定持续时间。
在本公开的一些方面中，所述方法还包括在所述第三相位中在所述至少一个高电压脉冲之前以所述第四功率水平生成电外科能量以感测靶组织的阻抗并且使所述发生器准备在功率上快速升高到所述第三功率水平。
在本公开的一些方面中，所述方法还包括在所述第三相位中在所述至少一个高电压脉冲之后以所述第四功率水平生成电外科能量以感测靶组织的阻抗。
根据本公开的方面，提供一种电外科发生器，其包括：耦合到电源的RF输出级；配置成测量靶组织的阻抗的传感器；以及配置成控制RF输出的控制器。所述RF输出级配置成从由所述电源提供的功率生成电外科能量以便输送到靶组织。所述控制器配置成控制所述RF输出级以：在第一相位中以第一功率水平生成电外科能量直到靶组织的被感测阻抗大于第一阈值阻抗；在第二相位中以第二功率水平生成电外科能量的多个脉冲，所述多个脉冲中的每个脉冲被生成直到靶组织的被感测阻抗大于针对该脉冲设置的第二阈值阻抗；以及在第三相位中以第三功率水平生成至少一个高电压脉冲持续预定持续时间以分割靶组织。
在本公开的一些方面中，所述第一阈值阻抗等于高于由所述传感器测量的初始组织阻抗的预定阻抗升高量。
在本公开的一些方面中，所述第二阈值阻抗等于高于由所述传感器测量的初始组织阻抗的可调节阻抗升高量。
在本公开的一些方面中，所述可调节阻抗升高量是针对每个相继脉冲基于调节因数增加、减小和保持相同中的至少一种，针对每个相继脉冲所述可调节阻抗升高量乘以所述调节因数。
根据本公开的方面，提供一种用于治疗靶组织的方法，其包括：在第一相位中以第一功率水平将电外科能量输送到靶组织直到靶组织的被感测阻抗大于阈值靶阻抗；在第二相位中以第二功率水平将电外科能量的多个脉冲输送到靶组织，每个脉冲被输送直到靶组织的被感测组织阻抗大于针对该脉冲设置的阈值靶阻抗；以及在第三相位中以第三功率水平将至少一个高电压脉冲输送到靶组织持续预定持续时间以分割靶组织。
根据本公开的方面，提供一种用于控制电外科发生器的方法，其包括：感测靶组织的阻抗；在阻抗感测相位中以初始功率水平生成电外科能量持续第一持续时间以感测靶组织的初始组织阻抗；在第一相位中以第一功率水平生成电外科能量直到靶组织的被感测阻抗大于第一阈值阻抗；以及在第二相位中以第二功率水平生成电外科能量的多个脉冲，每个脉冲被生成直到靶组织的被感测阻抗大于针对该脉冲设置的第二阈值阻抗。
在本公开的一些方面中，所述初始功率水平和所述第一持续时间被设置成使得生成的电外科能量对靶组织具有很小的影响。
本公开的任何以上方面和实施例中可以组合而不脱离本公开的范围。
附图说明
在本文中参考附图描述本公开的各实施例，其中：
图1是根据本公开的实施例的电外科系统的电外科发生器和其它部件的透视图；
图2是图1的电外科发生器的前视图；
图3是图2的电外科发生器的发生器电路的方块图；
图4是图示，示出根据本公开的实施例的针对三个相位的取决于时间由图3的发生器电路生成的电外科能量的输出功率分布；
图5-7是流程图，示出根据本公开的实施例的控制不同操作相位期间从发生器电路输出的功率的方法；
图8是图示，示出根据本公开的实施例的针对另一相位的取决于时间由图3的发生器电路生成的电外科能量的输出功率分布；以及
图9是流程图，示出根据本公开的实施例的控制另一相位期间从发生器电路输出的功率的方法。
具体实施方式
在下面参考附图描述本公开的特定实施例。在以下描述中，未详细地描述公知的功能或构造以避免以不必要的细节使本公开晦涩。
本公开提供用于切割组织的系统和方法。方法可以作为由电外科发生器的控制器(例如，微控制器)执行的计算机可读指令实现。发生器包括配置成经由至少一个有源电极将电外科能量供应到组织的RF输出级，所述至少一个有源电极配置成将电外科能量施加到组织，配置成测量组织的阻抗的感测电路，以及控制器。根据本公开的发生器可以执行例如包括切割、凝固、消融和血管闭合程序的单极和/或双极电外科程序。
发生器可以包括用于与各种电外科器械(例如，单极器械、返回电极、双极电外科钳、脚踏开关等)接口的多个输出。此外，发生器包括配置成生成专门适合于各种电外科模式(例如，切割、混合、凝固、具有止血的分割、电灼、喷雾等)和程序(例如，单极、双极、血管闭合)的射频能量的电子电路。在实施例中，发生器可以嵌入、集成或以另外方式耦合到电外科器械，提供全合一电外科装置。
本公开的系统和方法在电外科切割程序中提供最佳组织效应。在以下操作相位上执行方法：(1)初始化组织效应，(2)通过基于阻抗的脉冲发生在靶组织中使热局部化，以及(3)用聚焦能量密度分离组织。在第一相位中，功率输送到靶组织直到组织阻抗升高到阈值之上。然后在中间关闭状态暂停能量输送以允许组织再水化。第一相位的目的是加热靶组织，但是在任何显著的能量输送之前不过度干燥靶组织。
在第一相位之前，方法也可以包括第四相位，其中少量功率输送到靶组织以感测靶组织的初始阻抗。靶组织的被感测初始阻抗用于确定器械的当前状态(例如以确认器械未处于开路状态)并且稳定传感器读数。
在第二相位中，来自发生器的功率输出以恒定速率脉冲发生以稳定地升高组织阻抗。该脉冲发生预调节靶组织的被切割区域中的组织以保证第三相位的窄带干燥。在实施例中，在第三相位之前第二相位不过度干燥组织。
在第三相位中，输送一个或多个高电压脉冲持续规定量或时间。这些脉冲输送分割靶组织的被切割区域中的组织所需的最终能量爆发。第三相位包含智能的基于阻抗的脉冲发生以保证组织分离。已发现较低阻抗组织(例如，孤立静脉、猪子宫系膜等)典型地仅仅需要一个高电压脉冲来分割靶组织，而较高阻抗组织(例如，薄组织、脂肪肠系膜等)需要两个或更多个脉冲来完全分割靶组织。因此，在第三相位中，脉冲继续生成并且输送到靶组织直到已生成预定数量的脉冲或者组织达到阈值阻抗，指示组织已经被分割。这允许切割算法的更智能切断并且保证完整切割。
图1是根据本公开的双极和单极电外科系统10的图示。系统10可以包括具有用于治疗患者的组织的一个或多个有源电极13(例如，电外科切割探针、消融电极等)的一个或多个单极电外科器械12。电外科交流电流由发生器300经由连接到发生器300的有源端子230(图3)的供应线14供应到器械12，允许器械12切割、凝固、消融和/或以另外方式治疗组织。交流电流通过返回电极垫16经由发生器300的返回端子332(图3)处的返回线18返回到发生器300。对于单极操作，系统10可以包括在使用中布置在患者上的多个返回电极垫16以通过最大化与患者的总接触面积最小化组织损伤的机会。另外，发生器300和返回电极垫16可以配置成用于监测所谓的“组织到患者”的接触从而保证足够的接触存在于其间以进一步最小化组织损伤的机会。
系统10也可以包括一个或多个双极电外科器械，例如具有用于治疗患者的组织的一个或多个电极的双极电外科钳110或双极电外科钳310。双极电外科器械可以用于开放式和/或腹腔镜外科程序。
双极电外科钳110包括外壳111和布置在轴112的远端处的相对的钳夹部件113和115。钳夹部件113和115具有分别布置在其中的一个或多个有源电极114和返回电极116。有源电极114和返回电极116通过电缆118连接到发生器300，所述电缆包括分别耦合到有源和返回端子330、332(图3)的供应和返回线14、18。电外科钳110在具有到有源和返回端子330和332的连接(例如，针脚)的连接器处经由布置在电缆118的端部处的插头耦合到发生器300，其中插头包括来自供应和返回线14、18的触头，如下面更详细地所述。
双极电外科钳210包括具有末端执行器224和一次性电极组件221的机械钳220。机械钳220包括第一和第二长形轴部件212和214。手柄部件216和218分别布置在轴部件212、214的近端部分处，配置成允许用户实现轴部件212和214中的至少一个相对于彼此的运动。末端执行器224包括分别从轴部件212和214的远端部分延伸的相对的钳夹部件242、244。钳夹部件242、244响应轴部件212、214的运动相对于彼此可移动。具有一对外壳半部270a、270b的外壳270配置成匹配地接合并且可释放地包含轴部件214的至少一部分。钳210包括从外壳270延伸的电缆228，所述电缆配置成将钳210电连接到电外科能量源，例如电外科发生器，如图1中所示。
参考图2，显示发生器300的正面340。发生器300可以是任何合适的类型(例如，电外科、微波等)并且可以包括多个连接器350-362以适应各种类型的电外科器械(例如，电外科器械12、电外科钳110、电外科钳210等)。
发生器300包括用户接口341，所述用户接口具有用于为用户提供各种输出信息(例如，强度设置、治疗完成指示器等)的一个或多个显示屏幕或信息面板342、344、346。显示屏幕342、344、346的中每一个与对应的连接器350-362关联。发生器300包括用于控制发生器300的合适的输入控制(例如，按钮、启动器、开关、触摸屏等)。显示屏幕342、344、346也配置成显示电外科器械(例如，电外科器械12、电外科钳110、电外科钳210等)的相应菜单的触摸屏。用户然后通过简单地触摸相应的菜单选项调节输入。
显示屏幕342控制单极输出和连接到连接器350和352的装置。连接器350配置成耦合到单极电外科器械(例如，电外科器械12)并且连接器352配置成耦合到脚踏开关(未显示)。脚踏开关提供附加输入(例如，发生器300的复制输入)。显示屏幕344控制单极和双极输出和连接到连接器356和358的装置。连接器356配置成耦合到其它单极器械。连接器358配置成耦合到双极器械。
显示屏幕346控制由可以插入连接器360和362中的钳110或钳210执行的双极闭合程序。发生器300通过连接器360和362输出能量，所述能量适合于闭合由钳110或钳210夹持的组织。特别地，显示屏幕346输出用户接口，所述用户接口允许用户输入用户定义强度设置。用户定义强度设置可以是允许用户调节一个或多个能量输送参数(例如，功率、电流、电压、能量等)或闭合参数(例如，能率限制器、闭合持续时间等)的任何设置。用户定义设置传输到控制器324，其中设置可以保存在存储器326中。在实施例中，强度设置可以是例如从一到十或从一到五的数字标度。在实施例中，强度设置可以与发生器300的输出曲线关联。强度设置可以特定于正在使用的每个钳110或钳210，使得各种器械为用户提供对应于钳110或钳210的特定强度标度。
图3显示图1的发生器300的发生器电路305的方块图，所述发生器具有控制器324、高电压DC电源327(“HVPS”)、RF输出级328和传感器电路329。HVPS327连接到AC源(例如，壁装电源插座)并且将高电压DC功率提供给RF输出级328，然后所述RF输出级将高电压DC功率转换成RF能量(例如，AC信号)并且将RF能量输送到有源端子330。能量经由返回端子332返回到那里。特别地，RF输出级328生成RF能量的正弦或矩形波形。RF输出级328配置成生成具有各种占空比、峰值电压、波形峰值因数和其它合适的参数的多个波形。某些类型的波形适合于特定电外科模式。例如，RF输出级328典型地在很适合于消融、熔化和剖切组织的切割模式下生成100％占空比正弦波形，并且在适合于烧灼组织以停止出血的凝固模式下生成1-25％占空比波形。
控制器324包括可操作地连接到存储器326的处理器325，所述存储器可以包括易失性存储器(例如，RAM)和/或非易失性存储器(例如，闪存介质、磁盘介质等)。处理器325包括可操作地连接到HVPS327和/或RF输出级328的输出端口，允许处理器325根据打开和/或闭合控制环方案控制发生器300的输出。闭环控制方案是反馈控制环，其中传感器电路329将反馈提供给控制器324(即，从用于感测各种组织参数、例如组织阻抗、流体存在、输出电流和/或电压等的一个或多个传感器获得的信息)，并且将反馈提供给控制器324。控制器324然后向HVPS327和/或RF输出级328发信号以分别调节DC和/或RF电源。本领域的技术人员将领会处理器325可以通过使用适合于执行本文中所述的计算和/或指令集的任何逻辑处理器(例如，控制电路)代替，包括但不限于现场可编程门阵列、数字信号处理器或这些逻辑处理器的组合。
处理器325耦合到用户接口341并且配置成响应用户输入修改发生器300的模式、能量设置和其它参数。发生器300配置成在各种模式下操作。在一个实施例中，发生器300可以根据以下模式生成输出：切割、混合、凝固、具有止血的分割、电灼、喷雾、这些模式的组合等。每个模式基于预编程功率曲线操作，所述预编程功率曲线以负载(例如，靶组织)的变化阻抗控制由发生器300输出的功率的大小。每个功率曲线包括由用户选择功率设置和负载的被测量阻抗限定的功率、电压和电流控制范围。
现在参考图4-9，发生器300的控制器324执行优化切割算法以便在切割程序期间控制电外科能量的输送。优化切割算法配置成在四个相位(即，阻抗感测(IS)、S1、S2和S3)中生成到达靶组织的电外科能量以有效地分离或分割靶组织。现在将更详细地描述用于每个相位的发生器设置。在一些情况下，发生器300将被设置为“关闭”或低功率状态以允许靶组织再水化从而在施加电外科能量之后降低靶组织的阻抗。在“关闭”状态下，电外科发生器300的输出被设置为具有从大约0W到大约5W的值的功率水平P0并且典型地被设置为尽可能接近0W。在一些实施例中，P0被设置为略高于0W以提供电外科能量的滴流并且提供以0W供应电外科能量的发生器的增强系统能力。
现在参考图4和5，在IS相位402在步骤501中开始之后，电外科发生器以恒定功率水平P1(步骤504)生成电外科能量持续设置持续时间ISTsense(步骤502)以允许图3的发生器电路305的控制器324确定靶组织的初始参数，例如初始组织阻抗Zlow，所述电外科能量输出到电外科器械并且由电外科器械输送到靶组织。如图5中所示，如果在步骤502中确定持续时间大于设置持续时间ISTsense，则在步骤506中将Zlow设置为等于那时的被感测阻抗。功率水平P1典型地被设置为从大约0W到大约5W的功率水平，并且在一些实施例中被设置为5W。持续时间ISTsense典型地被设置为从大约10ms到大约500ms，并且在一些实施例中被设置为100ms，从而提供足够的时间以便稳定传感器读数。在IS相位期间将电外科能量施加到靶组织期间不发生组织的明显变化。
通过以功率水平P1将电外科能量施加到组织持续持续时间ISTsense，发生器300可以基于被感测初始组织阻抗Zlow与上阈值Zsensehigh的比较确定电外科器械是否处于“打开”状态。例如，例如当没有组织布置在器械的钳夹之间时，大约500Ω到大约2000Ω或以上的上阈值Zsensehigh可以被设置以便指示器械处于“打开”状态。在一些实施例中，上阈值Zsensehigh可以被设置为1500Ω。
在一些实施例中，可以在IS相位期间通过比较初始组织阻抗Zlow与用于将靶组织分类为低阻抗组织或高阻抗组织的阈值组织阻抗值TissueType可选地确定组织的类型。例如，当在步骤508中初始组织阻抗Zlow被确定为小于阈值组织阻抗值TissueType(即，初始组织阻抗Zlow被确定为不大于或等于阈值组织阻抗值TissueType)时，靶组织在步骤510中被设置为低阻抗组织。低阻抗组织可以仅仅需要一个或两个高电压脉冲来分割组织。在另一方面，当在步骤508中初始组织阻抗Zlow被确定为大于或等于阈值组织阻抗值TissueType时，靶组织在步骤512中被设置为高阻抗组织。高阻抗组织可以需要两个或更多个高电压脉冲来分割组织。在已确定并且设置组织的类型之后，IS相位结束并且过程在步骤514中离开IS相位进入第一相位S1。
现在参考图4和6，在步骤601中开始的S1相位404或预加热相位期间，电外科发生器300在步骤602中以恒定功率水平P3生成电外科能量直到在步骤604中确定组织阻抗从被感测初始阻抗Zlow增加阈值阻抗升高量Zrise，即，直到确定组织阻抗大于Zlow+Zrise，从而使组织准备切割。功率水平P3典型地被设置为从大约10W到大约100W的功率值，并且在一些实施例中被设置为40W。Zrise典型地被设置为从大约5Ω到大约100Ω的阻抗值，并且在一些实施例中被设置为40Ω。电外科能量以功率水平P3生成并且施加到靶组织直到靶组织的阻抗已从被感测初始阻抗Zlow增加Zrise从而达到Zlow+Zrise的阈值阻抗值。
一旦在步骤604中确定靶组织的被感测阻抗已达到Zlow+Zrise，组织已被预加热并且在步骤610中通过将功率设置为功率水平P0将发生器300设置为“关闭”状态以减小或停止将电外科能量输送到靶组织。在进入S2相位406之前发生器300被设置为“关闭”状态持续持续时间TS1S2off(步骤612和614)。在进入S2相位406之前将发生器300设置为“关闭”状态允许靶组织再水化并且减小靶组织的阻抗。TS1S2off典型地被设置为从大约5ms到大约1000ms的持续时间，并且在一些实施例中被设置为50ms。
如果在步骤606中确定靶组织的被感测阻抗在时间S1ZriseLimit内未达到Zlow+Zrise，则在步骤608中由于缺少对电外科能量的施加的组织响应而切断来自电外科发生器300的输出并且停止切割算法。S1ZriseLimit典型地被设置为从大约0ms到大约12000ms，并且在一些实施例中被设置为4000ms。
现在参考图4和7，在步骤701中开始的S2相位406期间，电外科发生器300在步骤706中以恒定功率水平P2生成电外科能量的多个脉冲以使靶组织准备切割。功率水平P2典型地被设置为从大约10W到大约200W的功率值，并且在一些实施例中被设置为20W。在每个脉冲之后，电外科发生器300的输出在步骤712中被设置为具有功率水平P0的“关闭”状态持续在步骤714中确定的固定持续时间TS2off以允许靶组织至少部分地再水化。TS2off典型地被设置为从大约5ms到大约1000ms的持续时间，并且在一些实施例中被设置为50ms。
每个脉冲基于步骤708中的靶组织的被感测阻抗与靶阻抗阈值的比较而具有可变持续时间，针对当前脉冲所述靶阻抗阈值等于高于Zlow的靶阻抗升高量Ztarget。当在步骤708中确定靶组织的被感测阻抗大于Ztarget+Zlow时，在步骤710中通过乘法因数Zmultiplier调节针对每个相继脉冲的靶阻抗Ztarget使得每个相继脉冲驱动靶组织达到新靶阻抗。在一些实施例中，针对每个相继脉冲的靶阻抗Ztarget是增加、减小或保持相同中的至少一种。
Ztarget典型地被初始化为从大约5Ω到大约1000Ω的阻抗值，并且在一些实施例中，Ztarget被初始化为50Ω。乘数Zmultiplier典型地被设置为大约1.01到大约10.0的值，并且在一些实施例中被设置为1.2。乘数Zmultiplier可以被调节以增加或减小S2相位406中的脉冲的数量，并且增加或减小在每个脉冲期间加热靶组织的时间的大小。在一些实施例中，乘数Zmultiplier可以替代地被设置为小于或等于1.00的值以保持或减小针对每个脉冲的靶阻抗Ztarget。电外科发生器300在S2相位406中继续生成脉冲直到被感测组织阻抗达到高于初始组织阻抗Zlow的阈值ZS2high。ZS2high典型地被设置为从大约50Ω到大约1000Ω，并且在一些实施例中被设置为100Ω。
S2相位406通过顺序地增加被切割区域中的靶组织的阻抗使组织准备最终切割以便在最终S3相位802保证窄带干燥。临近S2相位406结束时，在步骤704中发生器被设置为电源“关闭”状态并且功率水平被设置为功率水平P0持续在步骤716中确定的持续时间TS2S3off以允许靶组织再水化并且在步骤718中进入S3相位802之前减小阻抗。TS2S3off典型地被设置为从大约5ms到大约500ms的持续时间，并且在一些实施例中被设置为100ms。
现在参考图8和9，在步骤901中开始的S3相位802期间，电外科发生器300在步骤922中以电压水平V1并且以功率水平P4生成电外科能量的高电压脉冲持续在步骤926中确定的持续时间S3Pulsetime以分割靶组织。用于电外科能量的高电压脉冲的电压水平V1典型地被设置为从大约50V到大约500V的电压。用于电外科能量的高电压脉冲的功率水平P4典型地被设置为从大约50W到大约500W的功率水平，并且在一些实施例中被设置为300W。
高电压脉冲的持续时间S3Pulsetime典型地被设置为从大约5ms到大约500ms的值，并且在一些实施例中被设置为10ms。在一些实施例中，在步骤924中确定靶组织的被感测阻抗达到阈值最小组织阻抗值S3Zrise之后在步骤926中确定高电压脉冲的持续时间S3Pulsetime。阈值最小组织阻抗值S3Zrise典型地被设置为从大约500Ω到大约3000Ω，并且在一些实施例中被设置为1500Ω。在S3相位802期间具有功率水平P4的高电压脉冲在持续时间上被限制到最大超时值S3Pulsetime。如果在S3高电压脉冲期间的被感测组织阻抗在步骤924和926中确定的预定时期S3Pulsetime内未达到S3Zrise，则发生器300切断电外科能量的生成。
在一些程序中，可能需要两个或更多个高电压脉冲来分割靶组织。待输送到靶组织的高电压脉冲的最大数量S3MaxPulse可以基于发生器中的预定设置或基于由执行该程序的临床医生设置的操作者设置。例如，较低阻抗组织(例如孤立静脉、猪子宫系膜等)典型地仅仅需要一个高电压脉冲来分割靶组织，而较高阻抗组织(例如薄组织、脂肪肠系膜等)可能需要两个或更多个高电压脉冲来完全分割靶组织。
如上面关于图5所述，可以在IS相位402期间通过比较初始组织阻抗Zlow与用于将靶组织分类为低阻抗组织或高阻抗组织的阈值组织阻抗值TissueType来确定组织的类型。例如，当初始组织阻抗Zlow小于阈值组织阻抗值TissueType时，靶组织被设置为低阻抗组织，仅仅需要一个或两个高电压脉冲来分割组织。当初始组织阻抗Zlow大于或等于阈值组织阻抗值TissueType时，靶组织被设置为高阻抗组织，需要两个或更多个高电压脉冲来分割组织。在一些实施例中，S3MaxPulse被设置为三个脉冲。阈值组织阻抗值TissueType可以被设置为从大约25Ω到大约500Ω的阻抗值，并且在一些实施例中被设置为100Ω。可以基于被确定组织类型调节用于高电压脉冲的电压水平V1。例如，当靶组织被确定为低阻抗组织时，电压水平V1可以被设置为300V，并且当靶组织被确定为高阻抗组织时，电压水平V1可以被设置为400V。
当S3相位802包括多于一个高电压脉冲时，针对相继高电压脉冲在每个高电压脉冲之后发生器被设置为功率水平P0持续持续时间S3offDuration以允许靶组织再水化并且减小组织阻抗。通过在高电压脉冲之间暂停将高电压能量供应到靶组织，可以获得靶组织的优化切割，同时最小化对周围组织的影响。持续时间S3offDuration可以被设置为从大约10ms到大约2000ms的持续时间，并且在一些实施例中被设置为1000ms。
在一些实施例中，可以由发生器基于被感测组织和/或器械性质控制输送到靶组织的电外科能量的高电压脉冲的数量。例如，在S3相位802期间，电外科发生器300可以以功率水平P4继续生成到达靶组织的高电压脉冲直到生成在步骤910中确定的高电压脉冲的预定数量，靶组织达到在步骤906中确定的预定阻抗阈值S3ExitImpedance，或由电外科发生器300生成的电外科能量的电压和电流之间的相位差超过在步骤908中确定的阈值相位差S3ExitPhase。预定阻抗阈值S3ExitImpedance典型地被设置为从大约500Ω到大约5000Ω的阻抗值，并且在一些实施例中被设置为2600Ω。阈值相位差S3ExitPhase典型地被设置为从大约0.78弧度到大约1.56弧度的相移，并且在一些实施例中被设置为1.56弧度。
在一些实施例中，S3相位802可以包括在每个高电压脉冲之前类似于IS相位402的S3前阻抗感测(IS)相位。如果在步骤920中确定S3相位802包括S3前IS相位402，则电外科发生器300初始地在步骤902中在每个高电压脉冲之前以功率水平P1生成电外科能量持续在步骤904中确定的持续时间S3Tsense从而在步骤922中斜升到具有功率水平P4的高电压脉冲之前帮助稳定来自传感器电路329的传感器读数。持续时间S3Tsense典型地被设置为从大约10ms到大约500ms，并且在一些实施例中被设置为100ms，从而提供足够的时间以便传感器读数稳定。也发现在每个高电压脉冲之前以功率水平P1代替功率水平P0施加电外科能量在测试期间更有利，允许发生器在高电压脉冲期间获得功率的快速升高。
在S3前IS相位402期间，感测组织和/或器械性质以分别在步骤906、908和910中确定是否已满足任何阈值退出条件，例如S3ExitPhase、S3ExitPhase或脉冲的预定数量。在一些实施例中，在第一S3脉冲之前的S3前IS相位402不检查退出条件使得至少一个高电压脉冲总是输送到靶组织以分割靶组织。
在一些实施例中，S3相位802也可以或替代地包括在每个高电压脉冲之后的S3后阻抗感测(IS)相位。电外科发生器300从具有功率水平P4的高电压脉冲斜降从而以功率水平P1输送电外科能量持续持续时间S3Tsense以允许传感器电路329稳定。在高电压脉冲完成之后S3后IS相位402允许传感器电路329监视延迟阻抗效应。这允许在高电压脉冲之后分别在步骤906、908和910中检查阈值退出条件(例如S3ExitPhase、S3ExitPhase或脉冲的数量)之前阻抗有足够的时间升高。
一旦已满足步骤906、908和910中的退出条件中的一个，组织被确定为已被分割并且方法在步骤912中结束。在步骤912中，发生器300也可以被停用或设置为功率水平P0。如果不满足任何退出条件，则在步骤914中确定过程是否已进入S3后IS相位402。如果确定过程已进入S3后IS相位402，则在步骤916中将发生器300电源“关闭”并且设置为功率水平P0。然后，在步骤918中确定电源“关闭”持续时间是否大于预定值，即S3offDuration。电源“关闭”持续时间可以在S3高电压脉冲之后立即开始或者可以改为在S3后IS相位402已完成之后开始。在电源“关闭”持续时间达到S3offDuration之后，过程返回到步骤902，其中控制发生器300以恒定功率水平P1生成电外科能量。
尽管已在附图中显示和/或在本文中论述本公开的若干实施例，但是本公开不旨在限定于此，原因是本公开旨在范围上与本领域所允许的一样宽并且说明书类似地进行阅读。所以，以上描述不应当被理解为限制，而是仅仅是特定实施例的举例说明。本领域的技术人员将预见在所附的权利要求的范围和精神内的其它修改。
Claims (23)
1.一种用于控制电外科发生器的方法，所述方法包括：
感测靶组织的阻抗；
在第一相位中以第一功率水平生成电外科能量直到靶组织的被感测阻抗大于第一阈值阻抗；
在第二相位中以第二功率水平生成电外科能量的多个脉冲，每个脉冲被生成直到靶组织的被感测阻抗大于针对该脉冲设置的第二阈值阻抗；以及
在第三相位中以第三功率水平生成至少一个高电压脉冲持续预定持续时间以分割靶组织。
2.根据权利要求1所述的方法，所述方法还包括在阻抗感测相位中以第四功率水平生成电外科能量以感测靶组织的初始组织阻抗。
3.根据权利要求2所述的方法，其中所述第一阈值阻抗等于高于所述初始组织阻抗的预定阻抗升高量。
4.根据权利要求2所述的方法，其中所述第二阈值阻抗等于高于所述初始组织阻抗的可调节阻抗升高量。
5.根据权利要求4所述的方法，其中所述可调节阻抗升高量是针对每个相继脉冲基于调节因数增加、减小和保持相同中的至少一种。
6.根据权利要求5所述的方法，其中针对每个相继脉冲所述可调节阻抗升高量乘以所述调节因数。
7.根据权利要求2所述的方法，所述方法还包括：
基于靶组织的被感测初始阻抗确定靶组织的组织类型；以及
在所述第三相位期间基于被确定组织类型生成多个高电压脉冲。
8.根据权利要求7所述的方法，其中，如果靶组织的被感测初始阻抗小于组织类型阈值阻抗值，则组织类型被确定为低阻抗组织类型并且在所述第三相位期间输送的高电压脉冲的数量被设置为第一值，并且
如果靶组织的被感测初始阻抗大于或等于组织类型阈值阻抗值，则组织类型被确定为高阻抗组织类型并且在所述第三相位期间输送的高电压脉冲的数量被设置为第二值，所述第二值大于所述第一值。
9.根据权利要求2所述的方法，所述方法还包括在所述第三相位中在所述至少一个高电压脉冲之前以所述第四功率水平生成电外科能量以感测靶组织的阻抗并且使所述发生器准备在功率上快速升高到所述第三功率水平。
10.根据权利要求2所述的方法，所述方法还包括在所述第三相位中在所述至少一个高电压脉冲之后以所述第四功率水平生成电外科能量以感测靶组织的阻抗。
11.根据权利要求1所述的方法，其中所述第二相位中的脉冲被施加直到被感测组织阻抗大于最大阈值阻抗值。
12.根据权利要求1所述的方法，所述方法还包括：如果靶组织的被感测阻抗超过最大阈值阻抗值则在所述第三相位期间停止生成至少一个高电压脉冲。
13.根据权利要求1所述的方法，所述方法还包括：如果至少一个高电压脉冲的电压和电流的相位差大于预定相位差值则停止在所述第三相位期间生成所述至少一个高电压脉冲。
14.根据权利要求1所述的方法，其中在所述第二相位中的多个脉冲中的每个脉冲之后将所述发生器设置为具有第五功率水平的关闭状态持续预定持续时间，所述预定持续时间被设置成使得在所述多个脉冲中的每个脉冲之后靶组织至少部分地再水化。
15.根据权利要求1所述的方法，其中在所述第三相位中的至少一个高电压脉冲的每个脉冲之后将所述发生器设置为具有第五功率水平的关闭状态持续预定持续时间，所述预定持续时间被设置成使得在每个脉冲之后靶组织至少部分地再水化。
16.根据权利要求1所述的方法，其中在所述第一、第二和第三相位中生成的每个脉冲之后将所述发生器设置为具有第五功率水平的关闭状态，每个关闭状态具有预定持续时间。
17.一种电外科发生器，其包括：
耦合到电源的RF输出级，所述RF输出级配置成从由所述电源提供的功率生成电外科能量以便输送到靶组织；
配置成感测靶组织的阻抗的传感器；以及
控制器，所述控制器配置成控制所述RF输出级以：
在第一相位中以第一功率水平生成电外科能量直到靶组织的被感测阻抗大于第一阈值阻抗；
在第二相位中以第二功率水平生成电外科能量的多个脉冲，所述多个脉冲中的每个脉冲被生成直到靶组织的被感测阻抗大于针对该脉冲设置的第二阈值阻抗；以及
在第三相位中以第三功率水平生成至少一个高电压脉冲持续预定持续时间以分割靶组织。
18.根据权利要求17所述的电外科发生器，其中所述第一阈值阻抗等于高于由所述传感器测量的初始组织阻抗的预定阻抗升高量。
19.根据权利要求17所述的电外科发生器，其中所述第二阈值阻抗等于高于由所述传感器测量的初始组织阻抗的可调节阻抗升高量。
20.根据权利要求19所述的电外科发生器，其中所述可调节阻抗升高量是针对每个相继脉冲基于调节因数增加、减小和保持相同中的至少一种，针对每个相继脉冲所述可调节阻抗升高量乘以所述调节因数。
21.一种用于治疗靶组织的方法，所述方法包括：
在第一相位中以第一功率水平将电外科能量输送到靶组织直到靶组织的被感测阻抗大于阈值靶阻抗；
在第二相位中以第二功率水平将电外科能量的多个脉冲输送到靶组织，每个脉冲被输送直到靶组织的被感测组织阻抗大于针对该脉冲设置的阈值靶阻抗；以及
在第三相位中以第三功率水平将至少一个高电压脉冲输送到靶组织持续预定持续时间以分割靶组织。
22.一种用于控制电外科发生器的方法，所述方法包括：
感测靶组织的阻抗；
在阻抗感测相位中以初始功率水平生成电外科能量持续第一持续时间以感测靶组织的初始组织阻抗；
在第一相位中以第一功率水平生成电外科能量直到靶组织的被感测阻抗大于第一阈值阻抗；以及
在第二相位中以第二功率水平生成电外科能量的多个脉冲，每个脉冲被生成直到靶组织的被感测阻抗大于针对该脉冲设置的第二阈值阻抗。
23.根据权利要求22所述的方法，其中所述初始功率水平和所述第一持续时间被设置成使得所生成的电外科能量对靶组织具有很小的影响。
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| CN111345115A (zh) * | 2017-11-13 | 2020-06-26 | Seb公司 | 用于厨房用具的温度限制或调节装置 |
| CN111345115B (zh) * | 2017-11-13 | 2022-06-07 | Seb公司 | 用于厨房用具的温度限制或调节装置 |
| CN110063785A (zh) * | 2018-01-23 | 2019-07-30 | 韦伯斯特生物官能(以色列)有限公司 | 采用不同温度限值的功率受控短持续时间消融 |
| CN109259849A (zh) * | 2018-08-28 | 2019-01-25 | 重庆金山科技（集团）有限公司 | 电外科能量发生器的控制系统 |
| CN115209820A (zh) * | 2019-12-30 | 2022-10-18 | 西拉格国际有限公司 | 用于向组织递送混合能量模态的电外科器械 |
| CN113440248A (zh) * | 2020-03-27 | 2021-09-28 | 奥林匹斯冬季和Ibe有限公司 | 电外科发生器、电外科系统和操作电外科发生器的方法 |
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Also Published As
| Publication number | Publication date |
|---|---|
| CA2855034A1 (en) | 2015-01-29 |
| AU2014203332A1 (en) | 2015-02-12 |
| US10285750B2 (en) | 2019-05-14 |
| CN104337567B (zh) | 2019-11-05 |
| US20150032100A1 (en) | 2015-01-29 |
| EP2832291A1 (en) | 2015-02-04 |
| AU2014203332B2 (en) | 2018-12-06 |
| JP6489771B2 (ja) | 2019-03-27 |
| JP2015024140A (ja) | 2015-02-05 |
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