CN103237512B - 用于切割和凝固组织的装置和技术 - Google Patents
用于切割和凝固组织的装置和技术 Download PDFInfo
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Abstract
本发明公开的各种实施例涉及驱动联接到外科器械的超声驱动系统的端部执行器的设备和方法。所述方法包括生成至少一个电信号。针对第一组逻辑条件监测所述至少一个电信号。
Description
相关专利申请的交叉引用
本专利申请要求2009年10月9日提交的且名称为“A Dual Bipolar andUltrasonic Generator for Electro-Surgical Instruments”的美国临时专利申请序列号61/250,217的权益,所述美国临时专利申请据此以引用方式全文并入本文中。
本专利申请还是2009年7月15日提交的且名称为“Ultrasonic Device forCutting and Coagulating with Stepped Output”的共同未决的美国专利申请序列号12/503,775的部分接续申请,所述共同未决的美国专利申请依据美国法典§119(e)第35条要求(1)2008年8月6日提交的且名称为“Ultrasonic Device for Cutting and Coagulatingwith Stepped Output”的美国临时专利申请序列号61/086,619的权益以及(2)2008年8月13日提交的且名称为“Ultrasonic Device for Cutting and Coagulating with SteppedOutput”的美国临时专利申请序列号61/188,790的权益,所述美国临时专利申请均据此以引用方式全文并入本文中。
技术领域
本公开一般涉及超声外科系统,更具体地涉及一种允许外科医生执行切割和凝固的超声系统。
背景技术
超声外科器械凭借此类器械的独特的性能特征而在外科手术中得到日益广泛的应用。根据具体器械构型和操作参数,超声外科器械能够通过凝固基本上同时进行组织切割和止血,从而有利地使患者创伤最小化。切割动作通常通过在器械远端处的端部执行器或刀片末端完成,该端部执行器将超声能量传输到接触端部执行器的组织。具有这一性质的超声器械可被配置用于开放性外科用途、腹腔镜式或内窥镜式外科手术,包括机器人辅助手术。
一些外科器械将超声能量用于精确切割和受控凝固两者。与电外科使用的温度相比,超声能量使用更低的温度来切割和凝固。通过高频振动(例如每秒55,500次),超声刀使组织中的蛋白变性以形成粘性凝固物。刀片表面施加在组织上的压力使血管塌缩并允许所述凝固物形成止血密封。切割和凝固的精度受外科医生的技术以及对功率电平、刀刃、组织牵引力和刀片压力的调节的控制。
然而,医疗装置的超声技术的主要问题仍为血管的密封。申请人和其他人完成的工作已表明,在应用标准超声能量之前,当血管的内部肌肉层从外膜层分离并运动离开时会产生最佳血管密封。目前实现这种分离的工作涉及增大施加到血管的夹持力。
此外,使用者并不总是能够获得正被切割的组织的视觉反馈。因此,当不能获得视觉反馈时,希望提供一些形式的反馈来提醒使用者切割已完成。此外,如果没有用于提示切割已完成的一些形式的反馈指示,使用者可能在即使切割已完成的情况下继续启动谐波器械,这样,当在钳口之间具有很少物质甚至没有物质的情况下启动谐波器械时产生的热量会对谐波器械以及周围组织造成可能的损害。
超声换能器可被模塑成具有第一支路和第二“动态”支路的等效电路,所述第一支路包括静电容,所述第二“动态”支路包括串联的电感、电阻和电容,所述电感、电阻和电容限定谐振器的机电性能。常规超声发生器可包括调谐电感器,所述调谐电感器用于解谐处于谐振频率的静电容,使得基本上所有发生器的电流输出均流入动态支路中。动态支路电流与驱动电压一起限定阻抗和相位幅值。因此,在使用调谐电感器的情况下,发生器的电流输出代表动态支路电流,并且因此发生器能够保持其驱动输出处于超声换能器的谐振频率。调谐电感器还转换超声换能器的相阻抗图以改善发生器的频率锁定能力。然而,调谐电感器必须与超声换能器的特定静电容匹配。具有不同静电容的不同超声换能器需要不同的调谐电感器。
用于将电能施加到组织以治疗和/或破坏组织的电外科装置也在外科手术中得到日益广泛的应用。电外科装置通常包括手持件、在远侧安装有端部执行器(例如,一个或多个电极)的器械。所述端部执行器可抵靠组织定位,使得电流被引入组织中。电外科装置可被配置成用于双极性或单极性操作。在双极性操作期间,电流分别通过端部执行器的有源电极和返回电极被引入组织中并从组织返回。在单极性操作期间,电流通过端部执行器的有源电极被引入组织中,并通过返回电极(例如,接地垫)返回,所述有源电极与所述返回电极分开地位于患者身体上。流过组织的电流所产生的热可在组织内和/或在组织之间形成止血密封,并因此可尤其适用于例如密封血管。电外科装置的端部执行器也可包括能够相对于组织运动的切割构件以及用以横切组织的电极。
由电外科装置施加的电能可通过与手持件连通的发生器传递至器械。电能可为射频(“RF”)能的形式。射频能为可在300千赫兹(kHz)至1兆赫兹(MHz)频率范围内的电能形式。在应用中,电外科装置可穿过组织传递低频射频能,这会引起离子振荡或摩擦,并实际上造成电阻性加热,从而升高组织的温度。由于受影响的组织与周围组织之间形成明显的边界,因此外科医生能够以高精确度进行操作,并在不损伤相邻的非目标组织的情况下进行控制。射频能的低操作温度适用于在密封血管的同时移除、收缩软组织、或对软组织塑型。射频能尤其良好地适用于结缔组织,所述结缔组织主要由胶原构成,并且在接触热时收缩。
由于其独特的驱动信号、感测和反馈需求,超声和电外科器械通常需要专用的发生器。另外,在其中器械为一次性的或可与手持件互换的情形中,超声和电外科发生器识别所用特定器械构型以及相应地优化控制和诊断过程的能力受限。此外,来自发生器的信号在与患者隔离的电路中的电容耦合尤其在较高的电压和频率范围的情形中可导致患者暴露于不可接受水平的泄漏电流中。
期望提供一种克服当前器械的某些缺陷的外科器械。本文所述的外科系统能够克服这些缺陷。
发明内容
在一个总体方面,实现所描述的实施例的原理的超声外科器械组件被配置成允许在外科手术过程中选择性地解剖、切割、凝固和夹紧组织。在一个实施例中,端部执行器联接到外科器械的超声驱动系统。联接到超声驱动系统的发生器生成第一超声驱动信号。所述超声驱动系统包括联接到波导的超声换能器以及联接到波导的端部执行器。所述超声驱动系统被配置成以谐振频率谐振。在一个方面,发生器是可操作的以驱动联接到外科器械的超声驱动系统的端部执行器。发生器是可操作的以生成至少一个电信号、针对第一组逻辑条件监测所述至少一个电信号、以及在满足所述第一组逻辑条件时触发发生器的第一响应。
附图说明
所述实施例的新颖结构在所附权利要求书中进行了具体描述。然而,对组织和操作方法来讲均可通过结合附图参照以下描述最深刻地理解所描述的实施例,其中:
图1是示出超声外科器械的一个实施例的透视图。
图2是超声外科器械的一个实施例的分解透视组件视图。
图3是夹持臂的一个实施例的示意图,其中示出了力的计算。
图4是常规振荡器在高功率和轻负载下的电流、电压、功率、阻抗和频率波形的图示。
图5是常规振荡器在高功率和重负载下的电流、电压、功率、阻抗和频率波形的图示。
图6是无负载的振荡器的一个实施例的电流阶跃函数波形与电压、功率、阻抗和频率波形的图示。
图7是轻负载的振荡器的一个实施例的电流阶跃函数波形与电压、功率、阻抗和频率波形的图示。
图8是重负载的振荡器的一个实施例的电流阶跃函数波形与电压、功率、阻抗和频率波形的图示。
图9示出了发生器的驱动系统的一个实施例,所述驱动系统形成用于驱动超声换能器的超声电信号。
图10示出了外科系统的一个实施例,所述外科系统包括超声外科器械以及包括组织阻抗模块的发生器。
图11示出了包括组织阻抗模块的发生器的驱动系统的一个实施例。
图12示出了可与外科系统一起使用的夹持臂组件的一个实施例。
图13是联接到刀片和夹持臂组件的组织阻抗模块的示意图,其中组织位于刀片与夹持臂组件之间。
图14示出了用于驱动联接到外科器械的超声驱动系统的端部执行器的方法的一个实施例。
图15A示出了确定组织状态变化并相应地激活输出指示器的一个实施例的逻辑流程图。
图15B是示出频率拐点分析模块的操作的一个实施例的逻辑流程图。
图15C是示出电压降分析模块的操作的一个实施例的逻辑流程图900。
图16示出了包括发生器以及可与其结合使用的各种外科器械的外科系统的一个实施例。
图17为图16所示外科系统的图。
图18是示出一个实施例中的动态支路电流的模型。
图19是一个实施例中的发生器架构的结构视图。
图20是可在发生器的一个实施例中实施的组织算法的逻辑流程图。
图21是图20所示组织算法的可在发生器的一个实施例中实施的信号评价组织算法部分的逻辑流程图。
图22是可在发生器的一个实施例中实施的用于评价图21所示信号评价组织算法的评价条件集合的逻辑流程图。
图23是发生器的一个实施例在典型的组织切割过程中的频率斜率(频率的一阶时间导数)与时间的关系波形的图示。
图23A是发生器的一个实施例在典型的组织切割过程中的频率斜率的斜率(频率的二阶时间导数)与虚线所示时间的关系波形的图示,该波形叠加在图23所示的波形之上。
图24是发生器的一个实施例在典型的组织切割过程中在涉及图23所示图示时的频率与时间的关系波形的图示。
图25是发生器的一个实施例在典型的组织切割过程中在涉及图23所示图示时的驱动功率与时间的关系波形的图示。
图26是发生器的一个实施例在老化测试过程中的频率斜率与时间波形的关系的图示。
图27是发生器的一个实施例在老化测试过程中在涉及图26所示图示时的频率与时间的关系波形的图示。
图28是发生器的一个实施例在老化测试过程中在涉及图26所示图示时的功耗与时间的关系波形的图示。
图29是多个发生器/器械组合在老化测试过程中频率随时间变化的波形的图示。
图30是发生器的一个实施例的归一化组合阻抗、电流、频率、功率、能量和温度波形的图示,所述发生器联接到超声器械以尽可能快地连续10次切割离体的猪空肠组织并同时保持发生器贯穿整个过程运行。
图31A是发生器的一个实施例在进行连续组织切割过程中在一段时间内的阻抗和电流与时间的关系波形的图示。
图31B是发生器的一个实施例在进行连续组织切割过程中在一段时间内的频率与时间的关系波形的图示。
图31C是发生器的一个实施例在进行连续组织切割过程中在一段时间内的功率、能量和温度与时间的关系波形的图示。
图32是发生器的一个实施例的频率、加权频率斜率波形、和温度与时间的关系波形的组合图示,所述加权频率斜率波形通过α值为0.1的指数加权移动平均方法计算得出。
图33是图32所示频率与时间的关系波形的图示。
图34是图32所示加权频率斜率与时间的关系波形的图示。
图35是发生器的一个实施例在对空肠组织进行十次切割的过程中频率与时间的关系波形的图示以及温度与时间信号的关系的图示。
图36是发生器的一个实施例在中间组织被激活的情况下对空肠组织进行十次切割的过程中图35所示频率与时间的关系波形的图示。
图37是发生器的一个实施例在对空肠组织进行十次切割的过程中频率斜率与时间的关系波形的图示。
图38是功率与时间的关系波形的图示,所述关系波形表示发生器的一个实施例在对空肠组织进行十次切割的过程中所消耗的功率。
图39是发生器的一个实施例在对空肠组织进行十次切割的过程中电流与时间的关系波形的图示。
图40是发生器的一个实施例的“跨回频率斜率阈值”参数结合频率斜率与时间的关系波形的图示。
图41是超声器械的一个实施例对离体颈动脉施加脉冲的组合图示,其中显示归一化的功率、电流、能量和频率波形与时间的关系。
图42A是发生器的一个实施例在进行连续组织切割过程中在一段时间内的阻抗和电流与时间的关系波形的图示。
图42B是发生器的一个实施例在进行连续组织切割过程中在一段时间内的频率与时间的关系波形的图示。
图42C是发生器的一个实施例在进行连续组织切割过程中在一段时间内的功率、能量和温度与时间的关系波形的图示。
图43是针对图41和图50A-C所示的脉冲施加计算得出的频率斜率波形的图示,该图示是按总比例绘制。
图44是针对图43所示的脉冲施加计算得出的频率斜率波形的图示的缩放视图。
图45是其他所关注数据(例如阻抗、功率、能量、温度)波形的图示。
图46是总结各种超声器械类型的加权频率斜率与功率电平的关系的图示。
图47是发生器的一个实施例的谐振频率、平均谐振频率和频率斜率与时间的关系波形的图示。
图48是图47所示谐振频率和平均谐振频率与时间的关系波形的缩放图。
图49是发生器的一个实施例的谐振频率和电流与时间的关系波形的缩放图。
图50是联接到超声器械的发生器的一个实施例的归一化组合功率、阻抗、电流、能量、频率和温度波形的图示。
具体实施方式
在详细说明超声外科器械的各种实施例之前,应该指出的是,例证性实施例的应用或使用并不局限于附图和说明书中详细示出的部件的构造和布置。例证性实施例可单独实施,也可与其他实施例、变型和修改形式结合在一起实施,并可以通过多种方式实践或执行。此外,除非另外指明,本文所用的术语和表达是出于方便读者而对例证性实施例进行描述的目的选取的,并非出于限制的目的。
此外,应当理解,下述实施例、实施例表达、例子中的任何一个或多个可与下述其他实施例、实施例表达和例子中的任何一个或多个结合。
各种实施例均涉及改进的超声外科器械,其被配置成在外科手术中使组织解剖、切割和/或凝固更有效。在一个实施例中,超声外科器械设备被配置为用于开放性手术中,但所述设备也可应用于其他类型手术中,例如腹腔镜式、内窥镜式和机器人辅助手术。通过选择性地使用超声能量,方便了多种用途。
将结合本文所述的超声器械描述各种实施例。以举例而非进行限制的方式提供此类说明,并且不旨在限制其范围和应用。例如,所述实施例中的任一个均可与多个超声器械结合使用,所述超声器械包括在例如美国专利5,938,633、5,935,144、5,944,737、5,322,055、5,630,420、和5,449,370中所描述的那些。
通过以下说明将变得显而易见的是,设想本文所述的外科器械的实施例可与外科系统的振荡器单元相关联地使用,由此振荡器单元的超声能量为当前的外科器械提供期望的超声致动。还设想,本文所述的外科器械的实施例可与外科系统的信号发生器单元相关联地使用,由此例如射频(RF)形式的电能被用来为与外科器械有关的使用者提供反馈。超声振荡器和/或信号发生器单元可与外科器械不可拆卸地一体化,或者可作为可电附接至外科器械的分离组件提供。
本外科设备的一个实施例由于其简单构造而被具体地配置成用于一次性使用。然而,还设想本外科器械的其他实施例可被配置成用于非一次性或多次使用。仅出于例证性目的,当前公开了本外科器械与相关联的振荡器和信号发生器单元的可拆卸连接,用于单个患者使用。然而,还设想本外科器械与相关联的振荡器和/或信号发生器单元的不可拆卸的一体式连接。因此,当前所述的外科器械的各种实施例可被配置成与可拆卸的和/或不可拆卸的一体化振荡器和/或信号发生器单元一起用于单次使用和/或多次使用,然而并非仅限于此,而是这些构造的所有组合均被设想为落入本公开的范围内。
参照图1-3,其示出包括超声外科器械100的外科系统19的一个实施例。外科系统19包括超声发生器30和超声外科器械100,所述超声发生器通过合适的传输介质例如缆线22连接至超声换能器50。尽管在当前公开的实施例中显示,发生器30与外科器械是100分开的,然而在一个实施例中,发生器30可与外科器械100整体形成,以形成一体式外科系统19。发生器30包括位于发生器30控制台的前面板上的输入装置406。输入装置406可包括生成适于编程发生器30的操作的信号的任何合适的装置,如随后将参照图9所述。仍参照图1-3,缆线22可包括多个电导体,用于将电能施加至超声换能器50的正(+)电极和负(-)电极。应注意,在一些应用中,超声换能器50可被称为“柄部组件”,这是因为在各种手术和操作过程中,外科系统19的外科器械100可被配置成使得外科医生可抓紧并操纵超声换能器50。合适的发生器30是Ethicon Endo-Surgery,Inc.(Cincinnati,Ohio)出售的GEN300,如以下美国专利中的一者或多者所公开的,所述美国专利全部以引用方式并入本文中:美国专利6,480,796(Method for Improving the Start Up of an Ultrasonic System Under ZeroLoad Conditions);美国专利6,537,291(Method for Detecting a Loose Blade in aHandle Connected to an Ultrasonic Surgical System);美国专利6,626,926(Methodfor Driving an Ultrasonic System to Improve Acquisition of Blade ResonanceFrequency at Startup);美国专利6,633,234(Method for Detecting Blade BreakageUsing Rate and/or Impedance Information);美国专利6,662,127(Method forDetecting Presence of a Blade in an Ultrasonic System);美国专利6,678,621(Output Displacement Control Using Phase Margin in an Ultrasonic SurgicalHandle);美国专利6,679,899(Method for Detecting Transverse Vibrations in anUltrasonic Handle);美国专利6,908,472(Apparatus and Method for AlteringGenerator Functions in an Ultrasonic Surgical System);美国专利6,977,495(Detection Circuitry for Surgical Handpiece System);美国专利7,077,853(Methodfor Calculating Transducer Capacitance to Determine Transducer Temperature);美国专利7,179,271(Method for Driving an Ultrasonic System to ImproveAcquisition of Blade Resonance Frequency at Startup);以及美国专利7,273,483(Apparatus and Method for Alerting Generator Function in an UltrasonicSurgical System)。
根据所述实施例,超声发生器30生成特定电压、电流、和频率例如55,500周每秒(Hz)的电信号。发生器30通过缆线22连接至柄部组件68,该柄部组件包括形成超声换能器50的压电陶瓷元件。响应于柄部组件68上的开关312a或通过另一缆线连接至发生器30的脚踏开关434,发生器信号被施加至换能器50,这引起其元件的纵向振动。用一个结构将换能器50连接至外科刀片79,因此当发生器信号被施加至换能器50时该刀片以超声频率振动。所述结构被设计成以选择的频率谐振,因此放大通过换能器50发起的运动。在一个实施例中,发生器30被配置成产生特定电压、电流和/或频率的输出信号,所述信号可在高分辨率、精度和再现性的情况下阶跃。
参照图4,在当前系统中,在时刻0时启动常规振荡器,从而使电流300升至大约340mA的期望设定点。在大约2秒处,施加轻负载,从而使电压310、功率320、阻抗330相应地增大且谐振频率340发生变化。
参照图5,在当前系统中,在时刻0时启动常规振荡器,从而使电流300升至大约340mA的期望设定点。在大约2秒处,施加增大的负载,从而使电压310、功率320、阻抗330相应地增大且谐振频率340发生变化。在大约7秒处,负载增大到使振荡器进入平坦功率模式的点,在所述平坦功率模式中,只要振荡器保持在电源的电压范围内,则负载的进一步增大使功率保持在35W。在平坦功率模式期间电流300发生改变,因此位移改变。在大约11.5秒处,负载减小至使电流300返回至大约340mA的期望设定点的点。电压310、功率320、阻抗330和谐振频率340随负载改变。
现在再次参照图1-3,超声外科器械100包括多件式柄部组件68,其适于使操作者与超声换能器50中所包含的声学组件的振动隔离。可将柄部组件68成形为使用者能够以常规方式抓握的形状,但设想主要通过器械的柄部组件提供的触发器状装置来抓握和操纵本超声外科器械100,如下文所述。尽管示出了多件式柄部组件68,然而柄部组件68可包括单个组件或一体式组件。超声外科器械100的近端通过将超声换能器50插入柄部组件68中来容纳并配合该换能器50的远端。在一个实施例中,超声外科器械100可作为一个单元附接到超声换能器50并且从该超声换能器移除。在其他实施例中,超声外科器械100和超声换能器50可形成为一体式单元。超声外科器械100可包括柄部组件68,所述柄部组件包括配合外壳部69、外壳部70和传输组件71。当本器械被配置成用于内窥镜式使用时,所述构造的尺寸设定成使传输组件71具有大约5.5mm的外径。超声外科器械100的细长传输组件71从器械柄部组件68正交地延伸。传输组件71可通过旋转旋钮29选择性地相对于柄部组件68旋转,如以下所进一步描述。柄部组件68可由耐用塑料构成,例如聚碳酸酯或液晶聚合物。也设想柄部组件68可另外由包括其他塑料、陶瓷或金属的多种材料制成。
传输组件71可包括外部管状构件或外部护套72、内部管状致动构件76、波导80和端部执行器81,所述端部执行器包括例如刀片79、夹持臂56和一个或多个夹持垫58。如随后所述,外部护套72、致动构件76和波导80或传输杆可接合在一起,以作为一个单元(与超声换能器50一起)相对于柄部组件68旋转。适于将超声能量从超声换能器50传输到刀片79的波导80可为柔性、半柔性或刚性的。如在本领域中所熟知,波导80也可被配置成放大通过波导80传输到刀片79的机械振动。波导80还可具有用于控制沿波导80的纵向振动增益的结构以及用于将波导80调谐到系统谐振频率的结构。具体地,波导80可具有任何合适的横截面尺寸。例如,波导80可具有大体上均匀的横截面或波导80可在多个截面处渐缩或可沿其整个长度渐缩。在当前实施例的一种表现形式中,波导的直径为约标称0.113英寸,以最小化刀片79的偏转量,使得最小化端部执行器81的近侧部分中的间隙。
刀片79可与波导80成为一体并形成为单个单元。在当前实施例的替代表现形式中,刀片79可通过螺纹连接、焊接接头或其他联接机构连接。刀片79的远端设置在波腹附近,以便在声学组件未被组织承载时将声学组件调谐至优选的谐振频率fo。当超声换能器50被供能时,刀片79的远端被配置成在例如大约10至500微米峰间范围内、并且优选地在约20至约200微米的范围内以例如55,500Hz的预定振动频率fo纵向运动。
具体参照图1-3,其中示出了与该超声外科器械100一起使用的夹持构件60的一个实施例,并且所述夹持构件被配置成与刀片79协作地操作。与刀片79结合的夹持构件60通常被称为端部执行器81,并且夹持构件60还通常被称为夹具。夹持构件60包括可枢转运动的夹持臂56,其连接至外部护套72的远端以及致动构件76,所述夹持臂与组织接合垫或夹持垫58结合。夹持臂56通过触发器34可枢转地运动,并且端部执行器81通过旋转旋钮29可旋转地运动。在实施例的一个表现形式中,夹持垫58由E.I.Du Pont de Nemours andCompany的商标名称为的低摩擦系数聚合材料形成,或由任何其他合适的低摩擦材料形成。夹持垫58安装在夹持臂56上,以与刀片79协作,夹持臂56的枢转运动将夹持垫58定位成与刀片79基本平行并接触,从而限定组织治疗区域。通过这种构造,组织被抓紧在夹持垫58与刀片79之间。如图所示,夹持垫58可设置有非平滑表面,例如锯齿状构型,以与刀片79协作来提高对组织的抓持。锯齿状构型或齿提供相对于刀片79的运动的牵引力。所述齿还提供相对于刀片79和夹持运动的反牵引力。本领域的技术人员应当理解,锯齿状构型只是许多组织接合表面的一个例子,以防止组织相对于刀片79的运动而运动。其他例证性的例子包括凸耳、十字交叉图案、胎面图案、喷珠或喷砂的表面。
由于正弦运动,运动的最大位移或振幅位于刀片79的最远侧部分,而组织治疗区域的近侧部分位于远侧末端振幅的大约50%的位置处。在操作期间,端部执行器81的近侧区域中的组织将脱水和变薄,并且端部执行器81的远侧部分将横切远侧区域中的组织,从而允许近侧区域中的脱水和变薄的组织朝远侧滑动至端部执行器81的更加活性的区域,以完成组织横切。
图3示出力图以及致动力FA(由致动构件76提供)与横切力FT(在最佳组织治疗区域的中点处测得)之间的关系。
FT=FA(X2/X1) (1)
其中FA等于近侧弹簧94(更少的摩擦损失)的弹簧预负载,并且在一个实施例中为约12.5磅,并且FT等于约4.5磅。
FT在夹持臂/刀片交界处如组织标记61a和61b所限定的区域中测得,在所述区域中发生最佳组织治疗。组织标记61a,61b在夹持臂56上被蚀刻或凸起,以为外科医生提供可视标记,从而使外科医生获得对最佳组织治疗区的清楚指示。组织标记61a,61b在距离上相隔约7mm,并且更优选地在距离上相隔约5mm。
图9示出发生器30的驱动系统32的一个实施例,其生成用于驱动超声换能器的超声电信号。驱动系统32是柔性的并且可生成处于期望频率和功率电平设定的超声电驱动信号416,以驱动超声换能器50。在各种实施例中,发生器30可包括多个分离的功能性元件,例如模块和/或块。尽管可通过举例说明某些模块和/或块,但可理解,可使用更多或更少的模块和/或块,并仍在实施例的范围内。此外,尽管各种实施例可按照模块和/或块的形式描述以有利于说明,然而这些模块和/或块可通过一个或多个硬件组件和/或软件组件和/或硬件组件和软件组件的组合加以实施,所述硬件组件为例如处理器、数字信号处理器(DSP)、可编程逻辑装置(PLD)、专用集成电路(ASIC)、电路、寄存器,所述软件组件为例如程序、子程序、逻辑。
在一个实施例中,发生器30的驱动系统32可包括用固件、软件、硬件或它们的任意组合实现的一个或多个嵌入式应用程序。发生器30的驱动系统32可包括各种可执行模块,例如软件、程序、数据、驱动器、应用程序接口(API)等。所述固件可存储在非易失性存储器(NVM),例如位屏蔽只读存储器(ROM)或闪速存储器中。在各种具体实施中,将固件存储在ROM中可保护闪速存储器。NVM可包括其他类型的存储器,包括例如可编程ROM(PROM)、可擦除可编程ROM(EPROM)、电可擦除可编程ROM(EEPROM)或电池支持的随机存取存储器(RAM),例如动态RAM(DRAM)、双数据率DRAM(DDRAM)和/或同步DRAM(SDRAM)。
在一个实施例中,发生器30的驱动系统32包括被实施成处理器400的硬件组件,用以在切割和/或凝固操作模式下执行程序指令,以监视超声外科器械100(图1)的各种可测量特征并生成用以驱动超声换能器50的阶跃函数输出信号。本领域的技术人员应当理解,发生器30和驱动系统32可包括更多或更少的组件,并且为了简明和清楚起见,本文仅描述了简化版本的发生器30和驱动系统32。在各种实施例中,如此前所论,硬件组件可实施为DSP、PLD、ASIC、电路和/或寄存器。在一个实施例中,处理器400可被配置成存储和执行计算机软件程序指令,以生成用以驱动超声外科器械100的各种组件(例如换能器50、端部执行器81和/或刀片79)的阶跃函数输出信号。
在一个实施例中,在一个或多个软件程序调度程序的控制下,处理器400执行根据所述实施例的方法产生阶跃函数,所述阶跃函数由包括电流(I)、电压(V)和/或针对各种时间间隔或周期(T)的频率(f)的驱动信号的分段波形形成。驱动信号的分段波形可通过形成多个时间间隔的常值函数的分段线性组合生成,所述常值函数的创建通过发生器30驱动信号例如输出电流(I)、电压(V)和/或频率(f)的阶跃实现。时间间隔或周期(T)可为预定的(例如固定的和/或通过使用者编程的)或可为可变的。可变时间间隔可通过以下方法限定:将驱动信号设定为第一值,以及在监测的特性中检测到变化之前,将驱动信号保持为该值。所监测特性的例子可包括例如换能器阻抗、组织阻抗、组织发热、组织横切、组织凝固等等。发生器30所生成的超声驱动信号包括但不限于能够以各种振动模式激发超声换能器50的超声驱动信号,所述振动模式例如为主要纵向模式及其谐波以及弯曲和扭转振动模式。
在一个实施例中,可执行模块包括存储在存储器中的一种或多种阶跃函数算法402,当执行这些算法时,处理器400产生包括电流(I)、电压(V)和/或针对各种时间间隔或周期(T)的频率(f)的驱动信号的分段波形形成的阶跃函数。驱动信号的分段波形可通过形成两个或更多个时间间隔的常值函数的分段线性组合产生,所述常值函数的创建通过发生器30的输出驱动电流(I)、电压(V)和/或频率(f)的阶跃实现。根据一种或多种阶跃输出算法402,可针对时间的预定固定时间间隔或周期(T)或时间的可变时间间隔或周期生成驱动信号。在处理器400的控制下,发生器30针对预定周期(T)或在预定条件被检测到之前以特定分辨率向上或向下阶跃(例如,递增或递减)电流(I)、电压(V)和/或频率(f),所述预定条件例如为所监测特性(例如,换能器阻抗、组织阻抗)的改变。在编程的递增或递减中,所述阶跃可变化。如果需要其他阶跃,则发生器30可适应性地基于测量到的系统特性增加或减少阶跃。
在操作中,使用者可利用位于发生器30的控制台的前面板上的输入装置406编程发生器30的操作。输入装置406可包括生成信号408的任何合适的装置,所述信号可被施加到处理器400以控制发生器30的操作。在各种实施例中,输入装置406包括按钮、开关、指轮、键盘、小键盘、触摸屏监视器、指点装置,所述输入装置远程连接到通用或专用计算机。在其他实施例中,输入装置406可包括合适的用户界面。因此,通过输入装置406,使用者可设定或编程电流(I)、电压(V)、频率(f)和/或周期(T),以编程发生器30的阶跃函数输出。随后处理器400通过将在线信号410发送到输出指示器412来显示选择的功率电平。
在各种实施例中,输出指示器412可为外科医生提供视觉、听觉和/或触觉反馈,以指示外科手术的状态,例如基于测量到的超声外科器械100的特性(例如,换能器阻抗、组织阻抗)或随后描述的其他测量来确定组织切割和凝固何时完成。以举例而非限制的方式,视觉反馈包括任何类型的视觉指示装置,其包括白炽灯或发光二极管(LED)、图形用户界面、显示器、模拟指示器、数字指示器、柱状图显示器、数字字母显示器。以举例而非限制的方式,听觉反馈包括任何类型的蜂鸣器、计算机产生的音调、计算机化语音、通过声音/语音平台与计算机相互作用的声音用户界面(VUI)。通过举例而非限制的方式,触觉反馈包括通过容纳柄部组件68的器械提供的任何类型的振动反馈。
在一个实施例中,处理器400可被配置或编程为生成数字电流信号414和数字频率信号418。这些信号414,418被施加到直接数字合成器(DDS)电路420,以调节至换能器50的电流输出信号416的振幅和频率(f)。DDS电路420的输出被施加到放大器422,所述放大器的输出被施加到变压器424。变压器424的输出是施加至超声换能器50的信号416,所述换能器通过波导80连接至刀片79(图2)。
在一个实施例中,发生器30包括一个或多个测量模块或组件,其可被配置成监测超声器械100(图1)。在所示实施例中,可采用处理器400来监测和计算系统特性。如图所示,处理器400通过监测供应到换能器50的电流和施加至换能器50的电压来测量换能器50的阻抗Z。在一个实施例中,采用电流感测电路426来感测流动通过换能器50的电流,并且采用电压感测电路428来感测施加至换能器50的输出电压。这些信号可通过模拟多路复用器430电路或开关电路结构施加到模数转换器432(ADC)。模拟多路复用器430将合适的模拟信号沿特定路线发送至ADC432,以用于转换。在其他实施例中,可采用多个ADC432来替代多路复用器430电路用于每一个测量的特性。处理器400接收ADC432的数字输出433,并基于电流和电压的测量值计算换能器阻抗Z。处理器400调节输出驱动信号416,使得所述驱动信号可产生期望的功率与负载的曲线关系。根据编程的阶跃函数算法402,处理器400可响应于换能器阻抗Z以任何合适的增量或减量使驱动信号416(例如,电流或频率)阶跃。
为了实际地使外科手术刀片79振动,例如致动刀片79,使用者激活脚踏开关434(图1)或位于柄部组件68上的开关312a(图1)。这种激活基于电流(I)、频率(f)和对应的时间周期(T)的编程的值将驱动信号416输出至换能器50。在预定的固定时间周期(T)或基于可测量系统特性(例如换能器50的阻抗Z的改变)的可变时间周期过后,处理器400根据编程的值改变输出电流阶跃或频率阶跃。输出指示器412将所述处理的具体状态传输给使用者。
发生器30的编程操作可参照图6、7和8进一步示出,图中分别针对发生器30在无负载状态、轻负载状态和重负载状态下显示电流300、电压310、功率320、阻抗330和频率340的图示。图6是发生器30的一个实施例在无负载状态下的电流300、电压310、功率320、阻抗330和频率340波形的图示。在所示实施例中,发生器30的电流300输出是阶跃的。如图6所示,发生器30在大约时刻0处被首次激活,从而导致电流300升至约100mA的第一设定点I1。电流300在第一设定点I1处保持第一周期T1。在第一周期T1的最后(例如在所示实施例中约1秒钟处),电流300的设定点I1通过发生器30根据软件(例如,一种或多种阶跃函数算法402)变化(例如阶跃)至约175mA的第二设定点I2并持续第二周期T2(例如在所示实施例中约2秒钟)。在第二周期T2的最后(例如在所示实施例中约3秒钟处),发生器30通过软件使电流300变化至约350mA的第三设定点I3。由于系统上无负载,因此电压310、电流300、功率320和频率响应仅是轻微的。
图7是发生器30的一个实施例在轻负载状态下的电流300、电压310、功率320、阻抗330和频率340波形的图示。参照图7,发生器30在大约时刻0处被启动,使电流300升至约100mA的第一电流300设定点I1。在约1秒处,电流300设定点在发生器30中通过软件变化至约175mA的I2,然后再次在约3秒处,发生器30使电流300设定点变化至约350mA的I3。电压310、电流300、功率320和频率340显示为响应于轻负载,与图4中所示类似。
图8是发生器30的一个实施例在重负载状态下的电流300、电压310、功率320、阻抗330和频率340波形的图示。参照图8,发生器30在大约时刻0处被启动,使电流300升至约100mA的第一设定点I1。在约1秒处,电流300设定点在发生器30中通过软件变化至约175mA的I2,然后再次在约3秒处,发生器30使电流300设定点变化至约350mA的I3。电压310、电流300、功率320和频率340显示为响应于重负载,与图5中所示类似。
本领域的技术人员应当理解,电流300阶跃函数设定点(例如,I1,I2,I3)和针对图6-8中所述的每个阶跃函数设定点的持续时间内的时间间隔或周期(例如,T1,T2)并非仅限于本文所述的值,而是可被调节成外科手术的给定设置所期望的任何合适的值。如根据设计特性或性能约束的给定设置的需要,可选择更多或更少的电流设定点和持续时间的周期。如此前所论,周期可通过编程预先确定或可根据可测量的系统特性改变。然而该实施例并非仅限于这种情况。
根据所述外科系统19的各实施例的操作性细节,可在采用外科器械切割和凝固血管的过程以及参照图9所述的换能器阻抗测量能力方面进一步描述上述外科系统19的操作,所述外科器械包括输入装置406。尽管结合操作细节描述了具体过程,然而可理解,所述过程仅提供如何通过外科系统19实施本文所述的一般功能性的例子。此外,除非另外指明,否则给定的过程不一定按照本文所呈现的次序执行。如此前所论,可采用输入装置406来将阶跃输出(例如,电流、电压、频率)编程至超声换能器50/刀片79组件。
因此,现在参照图1-3和图6-9,一种用于密封血管的技术包括在应用标准超声能量来横切和密封血管之前将血管的内部肌肉层与外膜层分离和远离。尽管常规方法已通过增大施加到夹持构件60的力实现了这种分离,然而本文公开的是不仅仅依赖夹持力来切割和凝固组织的另一种设备和方法。为了更有效地分离血管的组织层,例如发生器30可被编程为将频率阶跃函数施加至超声换能器50,从而根据阶跃函数在多种模式下机械地置换刀片79。在一个实施例中,频率阶跃函数可通过用户界面406编程,其中使用者可选择阶跃频率程序、针对每个阶跃的频率(f)和针对将激发超声换能器50的每个阶跃的持续时间内的对应时间周期(T)。使用者能够通过针对多个周期设置多个频率来编程完整的操作循环,以执行各种外科手术。
在一个实施例中,在施加第二超声频率以切割和密封血管之前,可初始设定第一超声频率,以机械地分离血管的肌肉组织层。通过举例而非限制的方式,根据程序的一个具体实施方式,一开始,发生器30被编程为在时间的第一周期T1(例如,小于大约1秒)输出第一驱动频率f1,其中第一频率f1显著偏谐振,例如fo/2、2fo或其他结构性谐振频率,其中fo是谐振频率(例如,55.5kHz)。第一频率f1结合夹持力提供对刀片79的低电平机械振动作用,机械地分离血管的肌肉组织层(亚治疗)而不引起谐振时通常发生的显著发热现象。在第一周期T1之后,在第二周期T2,发生器30被编程为将驱动频率自动切换为谐振频率fo,以横切和密封血管。第二周期T2的持续时间可通过使用者确定的切割和密封血管实际占用的时间长度,或可基于所测量到的系统特性(例如换能器阻抗Z)而被编程或确定,如以下更详细的描述。
在一个实施例中,组织/血管横切过程(例如将血管的肌肉层与外膜层分离并横切/密封血管)可通过感测换能器50的阻抗Z的特性而自动化,以检测组织/血管的横切何时开始。阻抗Z可与肌肉层的横切相关,并与血管的横切/密封相关,从而提供用于处理器400的触发器,以产生频率和/或电流阶跃函数输出。如在前参照图9所述,在刀片79处于各种负载下时,换能器50的阻抗Z可基于流过换能器50的电流和施加至换能器50的电压而通过处理器400计算。因为换能器50的阻抗Z与施加到刀片79的负载成比,所以随着刀片79上的负载增大,换能器50的阻抗Z也增大,并且随着刀片79上的负载减小,换能器50的阻抗Z也减小。因此,换能器50的阻抗Z可被监测,以检测从外膜层脱离的血管的内部肌肉组织层的横切,并且还可被监测以检测血管何时被横切和密封。
在一个实施例中,超声外科器械110可响应于换能器阻抗Z根据所编程的阶跃函数算法进行操作。在一个实施例中,频率阶跃函数输出可基于换能器阻抗Z与一个或多个预定阈值的比较而开始,所述一个或多个预定阈值可与刀片79上的组织负载相关。当换能器阻抗Z转变至高于或低于(例如,超过)阈值时,处理器400施加数字频率信号418至DDS电路420,以响应于换能器阻抗Z通过根据一种或多种阶跃函数算法402的预定阶跃改变驱动信号416的频率。在操作中,刀片79首先位于组织治疗部位处。处理器400施加第一数字频率信号418,以设定非谐振(例如,fo/2、2fo或其他谐振频率,其中fo是谐振频率)的第一驱动频率f1。驱动信号416响应于柄部组件68上的开关312a或脚踏开关434的启动而施加至换能器50。在这个周期中,超声换能器50以第一驱动频率f1以机械方式启动刀片79。力或负载可施加至夹持构件60和刀片79,以有利于该过程。在这个周期中,处理器400监测换能器阻抗Z,直至刀片79上的负载发生变化并且换能器阻抗Z超过指示组织层被横切的预定阈值为止。随后,处理器400施加第二数字频率信号418,以设定第二驱动频率f2,例如谐振频率fo或用于横切、凝固和密封组织的其他合适频率。组织的另一部分(例如,血管)随后被抓紧于夹持构件60与刀片79之间。现在,通过致动脚踏开关434或柄部组件68上的开关312a,换能器50被第二驱动频率f2的驱动信号416赋能。本领域的技术人员应当理解,驱动电流(I)输出也可如参照图6-8所述基于换能器阻抗Z而阶跃。
根据一个阶跃函数算法402,处理器400最初设定显著偏谐振的第一驱动频率f1,以将血管的内部肌肉层与外膜层分离。在此操作周期中,处理器400监测换能器阻抗Z,以确定内部肌肉层何时被横切或与外膜层分离。因为换能器阻抗Z与施加至刀片79的负载相关,所以例如切割更多的组织能够减小刀片79上的负载和换能器阻抗Z。当换能器阻抗Z降到预定阈值以下时会探测到内部肌肉层的横切。当换能器阻抗Z的变化指示血管已与内部肌肉层分离时,处理器400将驱动频率设定为谐振频率fo。随后在刀片79与夹持构件60之间抓紧血管,并且通过致动脚踏开关或柄部组件68上的开关来启动换能器50以横切并密封血管。在一个实施例中,从接触组织的初始点至肌肉层正好被横切和密封之前的点,阻抗Z的变化可介于约1.5至约4倍于基本阻抗测量值之间的范围内。
图10示出外科系统190的一个实施例,其包括超声外科器械120以及包括组织阻抗模块502的发生器500。尽管在当前公开的实施例中,发生器500被显示为与外科器械120分离,然而在一个实施例中,发生器500可与外科器械120形成为一体以形成一体式外科系统190。在一个实施例中,发生器500可被配置成监测组织的电阻抗Zt并基于组织阻抗Zt控制时间和功率电平的特性。在一个实施例中,可通过将亚治疗射频(RF)信号施加至组织并通过夹持构件60上的返回电极测量通过组织的电流来确定组织阻抗Zt。在图10所示的实施例中,外科系统190的端部执行器810部分包括连接至外部护套72的远端的夹持臂组件451。刀片79形成第一(例如,激励)电极,并且夹持臂组件451包括形成第二(例如,返回)电极的导电部分。组织阻抗模块502通过合适的传输介质(例如,缆线504)连接至刀片79和夹持臂组件451。缆线504包括多个电导体,所述电导体用于将电压施加至组织并且提供用于使流过组织的电流返回至阻抗模块502的返回路径。在各种实施例中,组织阻抗模块502可与发生器500整体形成或者可被设置成连接至发生器500的分离电路(以虚线显示以示出这种选择)。发生器500基本上类似于具有组织阻抗模块502的附加特征的发生器30。
图11示出发生器500的驱动系统321的一个实施例,所述发生器包括组织阻抗模块502。驱动系统321生成超声电子驱动信号416,用以驱动超声换能器50。在一个实施例中,组织阻抗模块502可被配置成测量抓紧于刀片79和夹持臂组件451之间的组织的阻抗Zt。组织阻抗模块502包括射频振荡器506、电压感测电路508和电流感测电路510。电压和电流感测电路508、510响应于施加至刀片79电极的射频电压vrf和流过刀片79电极、组织和夹持臂组件451的导电部分的射频电流irf。感测到的电压vrf和电流irf经由模拟多路复用器430通过ADC432转换成数字形式。处理器400接收ADC432的数字化输出433,并通过计算通过电压感测电路508和电流感测电路510测量到的射频电压vrf与电流irf的比率来确定组织阻抗Zt。在一个实施例中,可通过感测组织阻抗Zt来检测内部肌肉层和组织的横切。因此,组织阻抗Zt的检测可与自动化处理一体化,所述自动化处理用于在横切组织之前将内部肌肉层与外部外膜层分离,而不引起通常在谐振时引起的显著的发热量。
图12示出夹持臂组件451的一个实施例,所述夹持臂组件可与外科系统190一起使用(图10)。在所示实施例中,夹持臂组件451包括安装到基部449的导电外壳472。所述导电外壳472是形成第二(例如,返回)电极的夹持臂组件451的导电部分。在一个具体实施中,夹持臂56(图3)可形成基部449,所述基部上安装有导电外壳472。在各种实施例中,导电外壳472可包括中心部分473以及至少一个向下延伸的侧壁474,所述侧壁可延伸至基部449的底面475以下。在所示实施例中,导电外壳472具有在基部449的相对两侧向下延伸的两个侧壁474。在其他实施例中,中心部分473可包括至少一个孔476,所述至少一个孔可被构造成容纳从基部449延伸的突出部477。在这些实施例中,突出部477可被压合到孔476中,以将导电外壳472固定到基部449。在其他实施例中,突出部477可在插入孔476中之后变形。在各种实施例中,可使用紧固件来将导电外壳472固定到基部449。
在各种实施例中,夹持臂组件451可包括例如布置在导电外壳472和基部449的中间的非导电性材料或绝缘材料,例如塑料和/或橡胶。电绝缘材料可防止电流在导电外壳472与基部449之间流动或短路。在各种实施例中,基部449可包括至少一个孔478,所述至少一个孔可被构造成容纳枢轴销(未示出)。例如,枢轴销可被构造成将基部449可枢转地安装到护套72(图10),使得夹持臂组件451可相对于护套72在打开位置与关闭位置之间旋转。在所示实施例中,基部449包括布置在基部449的相对侧上的两个孔478。在一个实施例中,枢轴销可由非导电性材料或绝缘材料(例如塑料和/或橡胶)形成或可包含非导电性材料或绝缘材料,所述材料可被配置成即使例如在基部449与导电外壳472电接触的情况下也防止电流流入护套72中。附加的夹持臂组件包括可采用的电极的各种实施例。这种夹持臂组件的例子在共同所有并同时提交的美国专利申请12/503,769、12/503,770和12/503,766中有所描述,所述美国专利申请中的每一者均以引用方式全文并入本文中。
图13是联接到刀片79和夹持臂组件415的组织阻抗模块502的示意图,其中组织514位于所述刀片与所述夹持臂组件之间。现在参照图10-13,发生器500包括被配置成在组织横切过程期间用于监测位于刀片79与夹持臂组件451之间的组织514的阻抗(Zt)的组织阻抗模块502。组织阻抗模块502通过缆线504联接到超声外科器械120。缆线504包括连接至刀片79(例如,正[+]电极)的第一“激励”导体504a以及连接至夹持臂组件451的导电外壳472(例如,负[-]电极)的第二“返回”导体504b。在一个实施例中,射频电压vrf被施加至刀片79,以使射频电流irf流过组织514。第二导体504b提供用于使电流irf返回至组织阻抗模块502的返回路径。返回导体504b的远端连接至导电外壳472,使得电流irf可从刀片79流过定位在导电外壳472与刀片79之间的组织514以及通过导电外壳472抵达返回导体504b。阻抗模块502通过第一导体504a和第二导体504b连接至电路中。在一个实施例中,射频能可通过超声换能器50和波导80施加至刀片79(图2)。值得注意的是,施加至组织514以用于测量组织阻抗Zt的射频能是对于组织514的治疗没有显著贡献或完全无贡献的低电平亚治疗信号。
根据对外科系统190的各种实施例的操作细节的描述,可就采用包括输入装置406和组织阻抗模块502的外科器械来切割和凝固血管的过程参照图10-13进一步描述上述外科系统190的操作。尽管已经结合操作细节描述了特定方法,然而可理解,所述方法仅提供如何通过外科系统190实施本文所述的一般功能性的例子。此外,除非另外指明,否则给定的方法不一定按照本文所呈现的次序执行。如在前所述,可采用输入装置406来对超声换能器50/刀片79组件编程阶跃函数输出(例如,电流、电压、频率)。
在一个实施例中,第一导体或线材可连接至器械120的外部护套72,并且第二导体或线材可连接至刀片79、换能器50。根据设计性质,刀片79和换能器50与外部护套72以及致动机构的其他元件电绝缘,所述致动机构是用于包括基部449和内部护套76的器械120。外部护套79以及包括基部449和内部护套76的致动机构的其他元件是彼此电连续的,即,其全部是金属的且彼此接触。因此,通过将第一导体连接至外部护套72并将第二导体连接至刀片79或换能器50以使组织存在于这两个导电路径之间,系统可监测组织的电阻抗,只要组织接触刀片79和基部449两者即可。为了有利于此接触,基部449本身可包括向外并可能向下突起的结构,以在将导电外壳472有效地整合于基部449中的同时确保组织接触。
在一个实施例中,超声外科器械120可响应于组织阻抗Zt根据编程的阶跃函数算法402进行操作。在一个实施例中,可基于组织阻抗Zt和与各种组织状态(例如脱水、横切、密封)相关的预定阈值的比较来开始频率阶跃函数输出。当组织阻抗Zt转变为高于或低于(例如超过)阈值时,处理器400将数字频率信号418施加到DDS电路420,以响应于换能器阻抗Zt根据阶跃函数算法402通过预定阶跃改变超声振荡器的频率。
在操作中,刀片79位于组织治疗部位处。组织514被抓紧于刀片79与夹持臂组件451之间,使得刀片79和导电外壳472与组织514进行电接触。处理器400施加第一数字频率信号418,以设定非谐振(如fo/2、2fo或其他结构性谐振频率,其中fo为谐振频率)的第一驱动频率f1。刀片79通过组织阻抗模块502供应的低电平亚治疗射频电压vrf电赋能。在组织阻抗Zt变化预定量之前,驱动信号416响应于柄部组件68上的开关312a或脚踏开关434的致动而被施加至换能器50/刀片79。然后,力或负载被施加至夹持臂组件451和刀片79。在该周期,超声换能器50在第一频率f1下机械地启动刀片79,结果由于施加在刀片79和夹持臂组件451的一个或多个夹持垫58之间的超声行为,因此组织514开始脱水,使得组织阻抗Zt减小。最后,随着组织通过超声动作和所施加的夹持力被横切,当组织完全被横切时,组织阻抗Zt变得非常高或无限大,使得刀片79与导电外壳472之间不存在导电路径。本领域的技术人员应当理解,驱动电流(I)输出还可如参照图6-8所述的那样基于组织阻抗Zt阶跃。
在一个实施例中,组织阻抗Zt可根据以下方法被阻抗模块502监测。可测量的射频电流i1经过第一激励导体504a而被传递至刀片79,经过组织514,然后经过导电外壳472和第二导体504b返回至阻抗模块502。随着组织514脱水以及被相对于一个或多个夹持垫58作用的刀片79的超声动作切割,组织514的阻抗增大,因此返回路径(即,第二导体504b)中的电流i1减小。阻抗模块502测量组织阻抗Zt并将代表性信号传递至ADC432,所述ADC432的信号输出433提供至处理器400。处理器400基于vrf和irf的这些测量值来计算组织阻抗Zt。处理器400响应于组织阻抗Zt的变化,通过任何合适的增量或减量使频率阶跃。处理器400控制驱动信号416,并可响应于组织阻抗Zt对振幅和频率作出任何必要的调整。在一个实施例中,处理器400可在组织阻抗Zt到达预定阈值时切断驱动信号416。
因此,通过举例而非限制的方式,在一个实施例中,在横切和密封血管之前,超声外科器械120可根据编程的阶跃输出算法操作以将血管的内部肌肉层与外膜层分离。如此前所论,根据一个阶跃函数算法,处理器400最初设定显著非谐振的第一驱动频率f1。换能器50被启动以将血管的内部肌肉层与外膜层分离,并且组织阻抗模块502将亚治疗射频电压vrf信号施加至刀片79。在此操作周期T1中,处理器400监测组织阻抗Zt,以确定内部肌肉层何时被横切或与外膜层分离。组织阻抗Zt与施加至刀片79的负载相关,例如当组织变得脱水或当组织被横切时,组织阻抗Zt变得非常高或无限大。在第二时间周期T2,组织阻抗Zt的变化指示血管已经从内部肌肉层分离或横切,并且使发生器500失效。随后,处理器400将驱动频率设定为谐振频率fo。随后,血管被抓紧于刀片79与夹持臂组件451之间,并且换能器50被再启动以横切和密封血管。对组织阻抗Zt的持续监测的操作提供血管何时被横切和密封的指示。另外,可监测组织阻抗Zt以提供组织切割和/或凝固过程完成的指示,或者当组织阻抗Zt达到预定阈值时停止超声发生器500的启动。可选定组织阻抗Zt的阈值,以例如指示血管已被横切。在一个实施例中,从起始点至肌肉层刚好被横切和密封之前的点,组织阻抗Zt可介于约10Ω至约1000Ω之间的范围内。
申请人已发现,操纵变化的电流设定点(增大以及减小)和停留时间的实验指示:在完成横切之前,所述实施例可用于将内部肌肉层与外部外膜层分离,从而获得改进的止血法并且潜在地降低在横切部位处的总能量(热)。此外,尽管已经参照用于确定肌肉层何时从外膜层分离的阻抗阈值检测方案描述了外科器械100,120,然而不采用任何检测方案的其他实施例也落在本公开的范围内。例如,外科器械100,120的实施例可在简化的外科系统中采用,其中在施加谐振功率以切割组织之前,施加非谐振功率以将所述层分离约1秒或更少的预定时间。各实施例并非仅限于这种情况。
已描述了外科系统19(图1)和190(图10)的各种实施例的操作性细节,可就采用包括输入装置406和组织阻抗模块502的外科器械切割和凝固组织的过程进一步大致描述以上外科系统19,190。尽管结合操作细节描述了特定方法,然而应当理解,所述方法仅提供如何通过外科系统19,190实施本文所述的一般功能性的例子。此外,除非另外指明,否则给定的方法不一定按照本文呈现的次序执行。如在前所讨论,可采用输入装置406来为超声换能器50/刀片79组件编程阶跃输出(例如,电流、频率)。
图14示出了用于驱动联接到外科器械的超声驱动系统的端部执行器的方法600的一个实施例。参照图1-3和6-14,通过举例而非限制的方式,超声外科器械100,120可根据方法600操作,以在横切和密封血管之前将血管的内部肌肉层与外膜层分离。因此,在各种实施例中,外科器械(例如,外科器械100,120)的端部执行器(例如,端部执行器81,810)可根据方法600驱动。发生器(例如,发生器30,500)联接到超声驱动系统。超声驱动系统包括联接到波导(例如,波导80)的超声换能器(例如,超声换能器50),并且端部执行器81联接到波导80。超声驱动系统被配置成在谐振频率(例如,55.5kHz)下谐振。在一个实施例中,在602,发生器30生成第一超声驱动信号。在604,超声换能器50响应于激活柄部组件(例如,柄部组件68)上的开关(例如,开关34)或连接至发生器30的脚踏开关(例如,脚踏开关434)而在第一周期通过第一超声驱动信号被致动。在第一周期过后,在606,发生器30生成第二超声驱动信号。在608,超声换能器50响应于激活柄部组件柄部组件68上的开关34或连接至发生器30的脚踏开关434而在第二周期通过第二超声驱动信号被致动。在相应的第一周期和第二周期中,所述第一驱动信号不同于所述第二驱动信号。在所述第一周期和第二周期中,所述第一驱动信号和第二驱动信号限定阶跃函数波形。
在一个实施例中,发生器30生成第三超声驱动信号。在第三周期,超声换能器50通过第三超声驱动信号被致动。在第一周期、第二周期和第三周期中,第三驱动信号不同于第一驱动信号和第二驱动信号。第一驱动信号、第二驱动信号和第三驱动信号限定第一周期、第二周期和第三周期中的阶跃函数波形。在一个实施例中,生成第一超声驱动信号、第二超声驱动信号和第三超声驱动信号的步骤包括:产生对应的第一驱动电流、第二驱动电流和第三驱动电流;以及在第一周期利用第一驱动电流致动超声换能器50,在第二周期利用第二驱动电流致动超声换能器50,并且在第三周期利用第三驱动电流致动超声换能器50。
在一个实施例中,发生器30在第一频率下生成第一超声驱动信号,所述第一频率不同于谐振频率。随后,在第一周期利用第一频率下的第一超声驱动信号致动超声换能器50。第一频率下的致动为端部执行器81提供第一水平的机械振动,其适于将第一组织与第二组织分离,例如以将血管的内部肌肉层与外膜层分离。发生器30生成处于谐振频率(例如,55.5kHz)的第二超声驱动信号,并且在第一周期之后的第二周期利用谐振频率下的第二超声驱动信号致动超声换能器50。第二、谐振频率下的致动为端部执行器81提供第二水平的机械振动,其适于在第一组织(例如血管)一旦其与内部肌肉层分离时对其进行横切和密封。在一个实施例中,在第一周期之后,谐振频率下的第二超声驱动信号由发生器30自动地生成。在一个实施例中,第一频率与谐振频率显著不同,并且第一周期小于约一秒。例如,在一个实施例中,第一频率由以下公式定义:f1=2*fo,其中f1是第一频率且fo是谐振频率。在另一实施例中,第一频率由以下公式定义:f1=fo/2,其中f1是第一频率且fo是谐振频率。还设想第一超声驱动信号、第二超声驱动信号和第三超声驱动信号用于以纵向、弯曲和扭转模式以及其谐波来激发超声换能器50的振动模式。
在一个实施例中,发生器30监测超声驱动系统的可测量特性并基于所测量到的特性生成第一驱动信号和第二驱动信号中的任一个。例如,发生器30监测超声换能器50的阻抗Z。发生器30包括适于测量换能器50的阻抗的电路。例如,电流感测电路(例如,电流感测电路426)感测流过换能器50的电流,并且电压感测电路(例如,电压感测电路428)感测施加至换能器50的输出电压。多路复用器(例如,多路复用器430)将适当的模拟信号沿特定路线发送至模数转换器(例如,ADC432),ADC432的数字输出被提供至处理器(例如,处理器400)。处理器400基于电流和电压的测量值计算换能器阻抗Z。
在一个实施例中,发生器500包括用以测量接触端部执行器(例如,端部执行器810)的组织部分的阻抗的阻抗模块(例如,组织阻抗模块502)。阻抗模块502包括射频振荡器(例如,射频振荡器506)以生成亚治疗射频信号。亚治疗射频信号施加至形成激励电极的端部执行器810的刀片(例如,刀片79)部分。所述组织部分被抓持在端部执行器810与夹持臂组件(例如,夹持臂组件451)和组织(例如,组织514)的阻抗的返回电极之间。随后,通过阻抗模块502的电压感测电路(例如,电压感测电路508)和电流感测电路(例如,电流感测电路510)测量组织阻抗。这些信号通过多路复用器430而被施加至ADC432。ADC432的数字输出被提供至处理器400,所述处理器基于通过组织的电流和施加至端部执行器810的刀片79部分的电压的测量值来计算组织阻抗Zt。
图15A-C示出操作的逻辑流程图700,800,900的各种实施例,以确定被超声外科器械操纵的组织的状态变化,并为使用者提供反馈,以指示组织已经经历这种状态变化或组织很可能已经经历这种状态变化。如本文所用,当组织从其他组织或骨骼层上分离时,当组织被切割或横切时,当组织被凝固时等等,组织可经历状态的变化,同时被超声外科器械的端部执行器(例如,图1和图10所示的超声外科器械100,120的端部执行器81,810)操纵。组织状态的变化可基于组织分离事件发生的可能性进行确定。
在各种实施例中,通过图9和图11所示的输出指示器412提供反馈。输出指示器412尤其适用于以下应用:其中被端部执行器81,810操纵的组织在使用者的视野之外且当组织中发生状态变化时使用者无法看见。根据参照逻辑流程图700,800,900所述的操作确定,输出指示器412与使用者通信,以通知组织状态发生变化。如此前所论,输出指示器412可被配置成向使用者提供各种类型的反馈,包括但不限于视觉、听觉和/或触觉反馈,以提醒使用者(例如外科医生、临床医生)组织已发生组织的状态或条件变化。以举例而非限制的方式,如此前所论,视觉反馈包括任何类型的视觉指示装置,包括白炽灯或LED、图形用户界面、显示器、模拟指示器、数字指示器、柱状图显示器、数字字母显示器。以举例而非限制的方式,听觉反馈包括任何类型的蜂鸣器、计算机产生的音调、计算机化语音、通过声音/语音平台与计算机相互作用的VUI。通过举例而非限制的方式,触觉反馈包括通过容纳柄部组件68的器械提供的任何类型的振动反馈。组织状态的变化可如前所述基于换能器和组织阻抗测量确定,或根据参照以下参照图15A-C中的逻辑流程图700,800,900所述的操作基于电压、电流和频率测量确定。
在一个实施例中,逻辑流程图700,800,900可被实施成可执行模块(例如,算法),其包括将被发生器30,500的处理器400(图9,11,14)部分执行的计算机可读指令。在各种实施例中,参照逻辑流程图700,800,900所述的操作可被实施成:一个或多个软件组件,例如,程序、子程序、逻辑;一个或多个硬件组件,例如,处理器、DSP、PLD、ASIC、电路、寄存器;和/或软件与硬件的组合。在一个实施例中,用于执行逻辑流程图700,800,900所述的操作的可执行指令可被存储在存储器中。当被执行时,所述指令使得处理器400根据逻辑流程图800和900中所述的操作确定组织状态的变化并通过输出指示器412为使用者提供反馈。根据这种可执行指令,处理器400监测并评价可从发生器30,500获得的电压、电流和/或频率信号样本,并根据对这些信号样本的评价来确定组织状态是否发生变化。如以下的进一步描述,组织状态的变化可基于超声器械的类型和激发所述器械的功率电平来确定。响应于所述反馈,超声外科器械100,120的操作模式可由使用者控制,或者可自动或半自动地被控制。
图15A示出确定组织状态的变化并相应地激活输出指示器412的一个实施例的逻辑流程图700。现在参照图15A所示的逻辑流程图700以及图9所示的发生器30的驱动系统32,在702,驱动系统32的处理器400部分对发生器30的电压(v)、电流(i)和频率(f)信号进行采样。在所示实施例中,在704,对频率和电压信号样本单独进行分析,以确定对应的频率拐点和/或电压降点。在其他实施例中,除了电压和频率信号样本之外或取代电压信号样本,可独立分析电流信号样本。在706,当前频率信号样本提供至频率拐点分析模块,以确定组织状态的变化,如图15B中的逻辑流程图800所示。在708,当前电压信号样本提供至电压降点分析模块,以确定组织状态的变化,如图15C中的逻辑流程图900所示。
频率拐点分析模块和电压降点分析模块基于与特定超声器械类型和驱动器械的能量水平相关联的关联性经验数据来确定组织状态何时发生变化。在714,来自频率拐点分析模块的结果710以及来自电压降点分析模块的结果712被处理器400读取。处理器400在716确定频率拐点结果710和/或电压降点结果712是否指示组织状态的变化。如果结果710,714没有指示组织状态的变化,则处理器400继续沿着“否”分支到达702并从发生器30中读取附加的电压和频率信号样本。在分析过程中利用发生器电流的实施例中,处理器400现在还将从发生器30读取附加的电流信号样本。如果结果710,714指示组织状态发生显著变化,则处理器400继续沿着“是”分支到达718,并激活输出指示器412。
如在前所讨论,输出指示器412可提供视觉、听觉和/或触觉反馈,以警告超声外科器械100,120的使用者组织状态已发生变化。在各种实施例中,响应于来自输出指示器412的反馈,发生器30,500的操作模式和/或超声器械100,120可以手动、自动或半自动方式控制。所述操作模式包括但不限于断开或关闭发生器30,500的输出功率,降低发生器30,500的输出功率,使发生器30,500的输出功率循环,脉冲调制发生器30,500的输出功率和/或从发生器30,500输出高功率短暂电涌。超声器械的响应于组织状态变化的操作模式可被选择成例如最小化例如夹持垫58(图1-3)的端部执行器81,810的发热效果,以防止或最小化对外科器械100,120和/或周围组织的可能损坏。此种情况是有利的,这是因为当换能器50在端部执行器81,810的钳口之间没有物质的情况下被启动时会迅速地发热,这与例如在组织已基本上与端部执行器分离时发生组织状态变化的情形一样。
图15B是示出频率拐点分析模块的操作的一个实施例的逻辑流程图800。在802,来自逻辑流程图700的706的频率样本被处理器400接收。在804,处理器400针对频率拐点分析计算指数加权移动平均值(EWMA)。计算EWMA以从频率样本中过滤掉来自发生器的噪声。根据频率移动平均值公式806和α值(α)808计算EWMA:
Stf=αYtf+(1-α)Stf-1 (2)
其中:
Stf=采样频率信号的当前移动平均值;
Stf-1=采样频率信号的在前移动平均值;
α=平滑因数;并且
Ytf=采样频率信号的当前数据点。
根据期望的滤波或平滑因数,α值808可从约0变化至约1,其中接近约0的小α值808提供大量的滤波或平滑,而接近约1的大α值808提供少量的滤波或平滑。α值808可基于超声器械类型和功率电平进行选择。在一个实施例中,块804,806和808可被实施成可变数字低通滤波器810,其中α值808确定滤波器810的截止点。一旦频率样本被滤波,则在812中如下计算频率样本的斜率:
频率斜率=Δf/Δt (3)
所计算的频率斜率数据点被提供至“慢速响应”移动平均值滤波器814,以计算针对频率斜率的EWMA移动平均值,从而进一步降低系统噪声。在一个实施例中,“慢速响应”移动平均值滤波器814的实施可通过如下方式实现:根据频率斜率移动平均值公式820和α值(α')822在818计算针对频率斜率的EWMA:
S'tf=α'Y'tf+(1-α')S'tf-1 (4)
其中:
S'tf=采样频率信号的频率斜率的当前移动平均值;
S'tf-1=采样频率信号的频率斜率的在前移动平均值;
α'=平滑因数;并且
Y'tf=采样频率信号的当前斜率数据点。
如在前参照数字滤波块810所讨论,根据期望的滤波或平滑因数,α'值822从约0变化至约1,其中接近0的小α'值822提供大量的滤波或平滑,而接近1的大α'值822提供少量的滤波或平滑。α'值822可基于超声器械类型和功率电平进行选择。
所计算的频率斜率数据点被提供至“快速响应”滤波器816,以计算针对频率斜率的移动平均值。在824,“快速响应”滤波器816基于多个数据点826计算针对频率斜率的移动平均值。
在所示实施例中,“慢速响应”移动平均值滤波器814的输出“斜率EWMA”被施加至加法器828的(+)输入,并且“快速响应”滤波器816的输出“斜率Avg”被施加至加法器828的(-)输入。加法器828计算“慢速响应”移动平均值滤波器814和“快速响应”滤波器816的输出之间的差值。这些输出之间的差值在830与预定极限832进行比较。极限832的确定是基于超声器械的类型和激活特定类型的超声器械的功率电平。极限832值可被预定和按照查找表等形式存储在存储器中。如果“斜率EWMA”和“斜率Avg”之间的差值不大于极限832,则处理器400沿着“否”分支继续并将值834返回至结果710块,以指示在采样频率信号中没有找到拐点,因此没有检测到组织状态的变化。然而,如果“斜率EWMA”和“斜率Avg”之间的差值大于极限832,则处理器400沿着“是”分支继续并确定找到频率拐点836,然后将点索引838返回至结果710块,以指示在采样的频率数据中发现拐点,因此检测到组织状态的变化。如在前参照图15A所述,如果发现频率拐点836,则在718(图15A),处理器400激活组织状态指示器718中的变化。
图15C是示出电压降分析模块的操作的一个实施例的逻辑流程图900。在902,来自逻辑流程图700的708的电压样本被处理器400接收。在904,处理器400针对频率拐点分析计算指数加权移动平均值(EWMA)。计算EWMA以从频率样本中过滤掉来自发生器的噪声。根据电压移动平均值公式906和α值(α)908计算EWMA:
Stv=αYtv+(1-α)Stv-1 (5)
其中:
Stv=采样电压信号的当前移动平均值;
Stv-1=采样电压信号的在前移动平均值;
α=平滑因数;并且
Ytv=采样电压信号的当前数据点。
如在前所讨论,根据期望的滤波或平滑因数,α值908可从0变化至1,并可基于超声器械类型和功率电平进行选择。在一个实施例中,块904,906和908可被实施成可变数字低通滤波器910,其中α值908确定滤波器910的截止点。一旦电压样本被滤波,则在912中如下计算电压样本的斜率:
电压斜率=Δv/Δt (6)
所计算的电压斜率数据点提供至“慢速响应”移动平均值滤波器914,以计算针对电压斜率的EWMA移动平均值,从而进一步降低系统噪声。在一个实施例中,“慢速响应”移动平均值滤波器914的实施可通过如下方式实现:根据电压斜率移动平均值公式920和α值(α')822在918中计算针对电压斜率的EWMA:
S'tv=α'Y'tv+(1-α')S'tv-1 (7)
其中:
S'tv=采样电压信号的电压斜率的当前移动平均值;
S'tv-1=采样电压信号的电压斜率的在前移动平均值;
α'=平滑因数;并且
Y'tv=采样电压信号的当前斜率数据点。
如在前参照数字滤波块910所讨论,根据期望的滤波或平滑因数,α'值922从约0变化至约1,其中接近约0的小α'值922提供大量的滤波或平滑,而接近约1的大α'值922提供少量的滤波或平滑。α'值922可基于超声器械类型和功率电平进行选择。
所计算的电压斜率数据点被提供至“快速响应”滤波器916,以计算针对电压斜率的移动平均值。在924,“快速响应”滤波器916基于多个数据点926计算针对电压斜率的移动平均值。
在所示实施例中,“慢速响应”移动平均值滤波器914的输出“斜率EWMA”被施加至加法器928的(+)输入,并且“快速响应”滤波器916的输出“斜率Avg”被施加至加法器928的(-)输入。加法器928计算“慢速响应”移动平均值滤波器914和“快速响应”滤波器916的输出之间的差值。这些输出之间的差值在930与预定极限932进行比较。极限932基于超声器械的类型以及激活特定类型的超声器械的功率电平确定。极限932值可被预定以及按照查找表等形式存储在存储器中。如果“斜率EWMA”和“斜率Avg”之间的差值不大于极限932,则处理器400沿着“否”分支继续并在940将计数器复位为零,然后将值934返回至结果710块,以指示在采样电压信号中没有找到电压降点,因此没有检测到组织状态的变化。然而,如果“斜率EWMA”和“斜率Avg”之间的差值大于极限932,则处理器400沿着“是”分支继续并在942将计数器递增。在944,例如,处理器400确定计数器是否大于1或一些其他预定的阈值。换句话讲,处理器400采用了关于电压降点的至少两个数据点。如果计数器不大于阈值(例如,在所示实施例中为1),则处理器400继续沿着“否”分支前进并将值934返回至结果710块,以指示在采样电压信号中没有找到电压降点,因此没有检测到组织状态的变化。如果计数器大于阈值(例如,在所示实施例中为1),则处理器400继续沿着“是”分支前进并确定找到电压降点936,并将点索引938返回至结果712块,以指示在采样的电压信号中找到了电压降点,因此检测到了组织状态的变化。根据在前参照图15A所讨论,如果找到电压点836,则在718(图15A),处理器400激活组织状态指示器718中的变化。
图16示出包括发生器1002以及可与其结合使用的各种外科器械的外科系统1000的一个实施例。发生器1002可被配置成与外科装置一起使用。根据各种实施例,发生器1002可被配置成与不同类型的不同外科装置一起使用,所述外科装置包括例如超声装置1004和电外科或射频外科装置(例如射频装置1006)。尽管在图16所示的实施例中,发生器1002被显示为与外科装置1004,1006分开,然而在一个实施例中,发生器1002可与外科装置1004,1006中的任一者形成为一体,以形成一体式外科系统。发生器1002包括位于发生器1002控制台的前面板上的输入装置1009。输入装置1009可包括生成适于对发生器1002的操作进行编程的信号的任何合适的装置。
图17为图16所示外科系统1000的图。在各种实施例中,发生器1002可包括多个分离的功能性元件,例如模块和/或块。不同的功能性元件或模块可被配置成用于驱动不同种类的外科装置1004,1006。例如,超声发生器模块1008可驱动超声装置,例如超声装置1004。电外科/射频发生器模块1010可驱动电外科装置1006。例如,相应的模块1008,1010可生成用于驱动外科装置1004,1006的相应的驱动信号。在各种实施例中,超声发生器模块1008和/或电外科/射频发生器模块1010可分别与发生器1002形成为一体。作为另外一种选择,模块1008,1010中的一个或多个可被设置成电联接到发生器1002的单独的电路模块。(模块1008和1010以虚线显示以示出此部分。)此外,在一些实施例中,电外科/射频发生器模块1010可与超声发生器模块1008形成为一体,或反之亦然。
根据所述实施例,超声发生器模块1008可生成驱动信号或特定电压、电流和频率例如55,500周每秒(Hz)的信号。所述一个或多个驱动信号可被提供至超声装置1004、尤其是可例如如上所述进行操作的换能器1014。在一个实施例中,发生器1002可被配置成生成特定电压、电流和/或频率的输出信号的驱动信号,所述驱动信号可在高分辨率、精度和再现性的情况下阶跃。
发生器1002可被启动以按任何合适的方式将驱动信号提供至换能器1014。例如,发生器1002可包括脚踏开关1020,所述脚踏开关经由脚踏开关缆线1022联接到发生器1002。临床医生可通过压下脚踏开关1020来启动换能器1014。此外,或作为脚踏开关1020的替代,超声装置1004的一些实施例可利用定位在手持件上的一个或多个开关,当被启动时,所述一个或多个开关可使发生器1002启动换能器1014。在一个实施例中,例如所述一个或多个开关可包括一对开关按钮1036a,1036b(图16)例如以确定装置1004的操作模式。当开关按钮1036a被压下时,例如,超声发生器1002可提供最大驱动信号至换能器1014,从而使所述换能器产生最大超声能量输出。压下开关按钮1036b可使超声发生器1002提供使用者可选的驱动信号至换能器1014,从而使所述换能器产生小于最大值的超声能量输出。除此之外或作为另外一种选择,装置1004可包括第二开关(未示出)以例如指示用于操作端部执行器1026的钳口的钳口闭合触发器的位置。此外,在一些实施例中,超声发生器1002可基于钳口闭合触发器的位置被启动(例如,当临床医生压下钳口闭合触发器以闭合钳口时,可施加超声能量)。
除此之外或作为另外一种选择,所述一个或多个开关可包括开关按钮1036c,当所述开关按钮被压下时,会使发生器1002提供脉冲输出。脉冲例如可按任何合适的频率和分组提供。在某些实施例中,例如,脉冲的功率电平可为与开关按钮1036a,1036b相关联的功率电平(最大值、小于最大值)。
应当理解,装置1004可包括开关按钮1036a,1036b,1036c的任意组合。例如,装置1004可被配置成具有仅如下两个开关按钮:开关按钮1036a和开关按钮1036c,开关按钮1036a用于产生最大超声能量输出,并且开关按钮1036c用于产生最大或小于最大功率电平的脉冲输出。这样,发生器1002的驱动信号输出构型可为5个连续信号和5或4或3或2或1个脉冲信号。在某些实施例中,例如可基于发生器1002中的EEPROM设定和/或一种或多种使用者功率电平选择来控制特定的驱动信号构型。
在某些实施例中,可提供双位开关来替代开关按钮1036c。例如,装置1004可包括用于产生最大功率电平的连续输出的开关按钮1036a和双位开关按钮1036b。在第一止动位置中,开关按钮1036b可产生小于最大功率电平的连续输出,并且在第二止动位置中,开关按钮1036b可产生脉冲输出(例如,根据EEPROM设定而定,具有最大功率电平或小于最大功率电平)。
根据所述实施例,电外科/射频发生器模块1010可生成驱动信号或具有足以使用射频(RF)能执行双极性电外科手术的输出功率的信号。在双极性电外科应用中,例如驱动信号可被提供至例如电外科装置1006的电极。因此,发生器1002可被配置成通过将足以处理组织(例如,凝固、烧灼、组织焊接)的电能施加到组织而达到治疗目的。
发生器1002可包括例如位于该发生器控制台前面板上的输入装置1045(图16)。输入装置1045可包括生成适于对发生器1002的操作进行编程的信号的任何合适的装置。在操作中,使用者可使用输入装置1045对发生器1002的操作进行编程或以其他方式进行控制。输入装置1045可包括能够生成可由发生器用来控制发生器1002的操作(例如,超声发生器模块1008和/或电外科/射频发生器模块1010的操作)的信号的任何合适的装置。在各种实施例中,输入装置1045包括按钮、开关、指轮、键盘、小键盘、触摸屏显示器、指点装置中的一种或多种,所述输入装置远程连接到通用或专用计算机。在其他实施例中,输入装置1045例如可包括合适的用户界面,例如显示于触摸屏显示器上的一个或多个用户界面屏幕。因此,通过输入装置1045,使用者例如可设定或编程发生器的各种操作参数,例如超声发生器模块1008和/或电外科/射频发生器模块1010所生成的驱动信号或信号的电流(I)、电压(V)、频率(f)、和/或周期(T)。
发生器1002也可包括例如位于发生器1002控制台的前面板上的输出装置1047(图16),例如输出指示器。输出装置1047包括一个或多个用于为使用者提供感观反馈的装置。此类装置例如可包括视觉反馈装置(例如,视觉反馈装置可包括白炽灯、发光二极管(LED)、图形用户界面、显示器、模拟指示器、数字指示器、条形图显示器、数字字母混合显示器、LCD显示屏幕、LED指示器)、听觉反馈装置(例如,听觉反馈装置可包括扬声器、蜂鸣器、可听见的计算机产生的音调、经计算机处理的语言、通过语音/语言平台与计算机相互作用的语音用户界面(VUI))或触觉反馈装置(例如,触觉反馈装置包括任何类型的振动反馈、触觉致动器)。
尽管可通过举例说明发生器1002的某些模块和/或块,但可理解,可使用更多或更少的模块和/或块,并仍在实施例的范围内。此外,尽管各种实施例可按照模块和/或块的形式描述以有利于说明,然而这些模块和/或块可通过一个或多个硬件组件和/或软件组件和/或硬件组件和软件组件的组合加以实施,所述硬件组件为例如处理器、数字信号处理器(DSP)、可编程逻辑装置(PLD)、专用集成电路(ASIC)、电路、寄存器,所述软件组件为例如程序、子程序、逻辑。
在一个实施例中,超声发生器驱动模块1008和电外科/射频驱动模块1010可包括被实施成固件、软件、硬件或它们的任意组合的一个或多个嵌入式应用程序。模块1008,1010可包括各种可执行模块,例如软件、程序、数据、驱动器、应用程序接口(API)等。所述固件可存储在非易失性存储器(NVM),例如位屏蔽只读存储器(ROM)或闪速存储器中。在各种具体实施中,将固件存储在ROM中可保护闪速存储器。NVM可包括其他类型的存储器,包括例如可编程ROM(PROM)、可擦除可编程ROM(EPROM)、电可擦除可编程ROM(EEPROM)或电池支持的随机存取存储器(RAM),例如动态RAM(DRAM)、双数据率DRAM(DDRAM)和/或同步DRAM(SDRAM)。
在一个实施例中,模块1008,1010包括硬件组件,所述硬件组件被实施成用于执行程序指令的处理器,以用于监测装置1004,1006的各种可测量特性并生成用于操作装置1004,1006的对应输出控制信号。在其中发生器1002与装置1004结合使用的实施例中,输出控制信号可切割和/或凝固操作模式驱动超声换能器1014。装置1004和/或组织的电特性可被测量并用于控制发生器1002的操作方面和/或作为反馈被提供给使用者。在其中发生器1002与装置1006结合使用的实施例中,输出控制信号可以切割、凝固和/或脱水模式将电能(例如射频能)提供至端部执行器1032。装置1006和/或组织的电特性可被测量并用于控制发生器1002的操作方面和/或为使用者提供反馈。在各种实施例中,如此前所论,硬件组件可实施为DSP、PLD、ASIC、电路和/或寄存器。在一个实施例中,处理器可被配置成存储和执行计算机软件程序指令,以生成用于驱动装置1004,1006的各种组件例如超声换能器1014和端部执行器1026,1032的阶跃函数输出信号。
图18示出根据一个实施例的超声换能器例如超声换能器1014的等效电路1050。电路1050包括第一“动态”支路和第二电容支路,所述第一“动态”支路具有串联连接并限定谐振器的机电性能的电感Ls、电阻Rs和电容Cs,并且第二电容支路具有静电容Co。驱动电流Ig可在驱动电压Vg下从发生器接收,其中动态电流Im流过第一支路,并且电流Ig–Im流过电容支路。可通过合适地控制Ig和Vg来实现对超声换能器的机电性能的控制。如上所述,常规发生器架构可包括调谐电感器Lt(在图18中以虚线显示),以用于在并联谐振电路中将静电容Co调谐成谐振频率,使得基本上所有发生器电流输出Ig全部流过动态支路。这样,通过控制发生器电流输出Ig来实现对动态支路电流Im的控制。然而,调谐电感器Lt对超声换能器的静电容Co是特定的,并且具有不同静电容的不同超声换能器需要不同的调谐电感器Lt。此外,因为调谐电感器Lt与静电容Co在单谐振频率下的标称值相匹配,所以仅在该频率下才能确保对动态分支电流Im的精确控制,并且当频率随着换能器温度向下偏移时,对动态支路电流的精确控制会折中。
发生器1002的实施例并不依赖于调谐电感器Lt来监测动态支路电流Im。相反,发生器1002可在施加用于特定超声外科装置1004的功率(连同驱动信号电压和电流反馈数据)之间使用静电容Co的实测值在动态行进的基础上(例如,实时)确定动态支路电流Im的值。因此,发生器1002的这些实施例能够提供虚拟调谐,以模拟被调谐的系统或通过任何频率的任何静电容Co值进行谐振,而非仅静电容Co的标称值所指示的单谐振频率。
图19是发生器1002的一个实施例的简化方框图,所述发生器如上所述除提供其他有益效果之外还提供无电感器调谐。发生器1002的其他细节在共同分配并同时提交的名称为“Surgical Generator For Ultrasonic And Electrosurgical Devices”且代理人案卷号为END6673USNP/100558的美国专利申请_____(现为美国专利_____)中有所描述,所述专利申请以引用方式全文并入本文中。参照图19,发生器1002可包括患者隔离台1052,所述患者隔离台经由功率变压器1056与非隔离台1054通信。功率变压器1056的次线圈1058容纳于隔离台1052中并可包括分接构型(例如,中心分接或非中心分接构型)来限定驱动信号输出1060a,1060b,1060c,以将驱动信号输出至不同外科装置(例如,超声外科装置1004和电外科装置1006)。具体而言,驱动信号输出1060a,1060c可将驱动信号(例如420VRMS驱动信号)输出至超声外壳装置1004,并且驱动信号输出1060b,160c可将驱动信号(例如100V RMS驱动信号)输出至电外科装置1006,其中输出1060b对应于功率变压器1056的中心接头。非隔离台1054可包括功率放大器1062,所述功率放大器具有连接至功率变压器1056的主线圈1064的输出。在某些实施例中,功率放大器1062可包括推挽放大器。例如,非隔离台1054还可包括逻辑装置1066,以用于对数字/模拟转换器(DAC)1068提供数字输出,而所述数字/模拟转换器(DAC)又将对应的模拟信号提供至功率放大器1062的输入。在某些实施例中,例如除其他逻辑电路之外,逻辑装置1066可包括可编程的门阵列(PGA)、场可编程的门阵列(FPGA)、可编程的逻辑装置(PLD)。因此,通过经由DAC1068控制功率放大器1062的输入,逻辑装置1066可控制在驱动信号输出1060a,1060b,1060c处出现的驱动信号的多个参数(例如,频率、波形形状、波形振幅)中的任一者。在某些实施例中,如下所述,逻辑装置1066结合处理器(例如以下所述的数字信号处理器)可实施多个基于数字信号处理(DSP)的算法和/或其他控制算法,以控制发生器1002所输出的驱动信号的参数。
可通过开关模式调节器1070将功率提供至功率放大器1062的功率轨。在某些实施例中,开关模式调节器1070例如可包括可调式降压调节器。例如,非隔离台1054还可包括第一处理器1074,在一个实施例中,所述第一处理器可包括DSP处理器,例如可从AnalogDevices(Norwood,MA)购得的Analog Devices ADSP-21469SHARC DSP,但可在各种实施例中采用任何合适的处理器。在某些实施例中,处理器1074可响应于由DSP处理器1074经由模拟/数字转换器(ADC)1076从功率放大器1062接收的电压反馈数据来控制开关模式功率转换器1070的操作。在一个实施例中,例如DSP处理器1074可经由ADC1076接收为输入,信号(例如射频信号)的波形包迹被功率放大器1062放大。随后,DSP处理器1074可控制开关模式调节器1070(例如,经由脉宽调制(PWM)输出),使得被提供至功率放大器1062的干线电压跟踪经放大信号的波形包迹。通过基于波形包迹以动态方式调制功率放大器1062的干线电压,功率放大器1062的效率相对于固定干线电压放大器方案可显著升高。
在某些实施例中,逻辑装置1066结合DSP处理器1074可实施直接数字合成器(DDS)控制方案,以控制发生器1002所输出驱动信号的波形形状、频率和/或幅值。在一个实施例中,例如逻辑装置1066可通过召回存储于动态更新的查找表(LUT)(例如RAM LUT)中的波形样本来实施DDS控制算法,所述动态更新的查找表可被嵌入FPGA中。此种控制算法尤其适用于其中可通过处于谐振频率的完全正弦电流驱动超声换能器(例如超声换能器1014)的超声应用。因为其他频率可激发寄生谐振,所以最小化或减小动态支路电流的总畸变可相应地最小化或减小不可取的谐振效应。因为发生器1002所输出的驱动信号的波形形状受输出驱动电路(例如,功率变压器1056、功率放大器1062)中所存在的各种畸变源的影响,所以基于驱动信号的电压和电流反馈数据可被输入至算法(例如由DSP处理器1074实施的误差控制算法)中,所述算法通过适当地以动态行进方式使存储于LUT中的波形样本预先畸变或修改来补偿畸变。在一个实施例中,对LUT样本所施加的预先畸变量或程度可根据所计算的动态支路电流与期望的电流波形形状之间的误差而定,其中所述误差可逐一样本地确定。这样,预先畸变的LUT样本在通过驱动电路被处理时,可使动态支路驱动信号具有期望的波形形状(例如正弦形状),以最佳地驱动超声换能器。因此,在此类实施例中,当考虑到畸变效应时,LUT波形样本将不呈现驱动信号的期望波形形状,而是呈现要求最终产生动态支路驱动信号的期望波形形状的波形形状。
非隔离台1054还可包括ADC1078和ADC1080,所述ADC1078和ADC1080经由相应的隔绝变压器1082,1084联接到功率变压器1056的输出,以分别用于对发生器1002所输出的驱动信号的电压和电流进行采样。在某些实施例中,ADC1078,1080可被配置成以高的速度(例如,80MSPS)进行采样,以能够对驱动信号进行过采样。在一个实施例中,例如ADC1078,1080的采样速度可实现驱动信号的约200x(根据频率而定)的过采样。在某些实施例中,可通过令单个ADC经由二路式多路复用器接收输入电压和电流信号来执行ADC1078,1080的采样操作。通过在发生器1002的实施例中使用高速采样,除可实现其他事物之外,还可实现对流过动态支路的复杂电流的计算(这在某些实施例中可用于实施上述基于DDS的波形形状控制)、对采样信号进行精确的数字滤波、以及以高精度计算实际功耗。ADC1078,1080所输出的电压和电流反馈数据可由逻辑装置1066接收及处理(例如,FIFO缓冲、多路复用)并被存储于数据存储器中,以供例如DSP处理器1074后续取回。如上所述,电压和电流反馈数据可用作算法的输入,以用于以动态行进方式使LUT波形样本预先畸变或修改。在某些实施例中,当采集到电压和电流反馈数据对时,此可需要基于逻辑装置1066所输出的对应LUT样本或以其他与所述对应LUT样本相关联的方式为每一所存储的电压和电流反馈数据对编索引。以此种方式使LUT样本与电压和电流反馈数据同步有助于预先畸变算法的正确定时和稳定性。
在某些实施例中,可使用电压和电流反馈数据来控制驱动信号的频率和/或幅值(例如,电流幅值)。在一个实施例中,例如,可使用电压和电流反馈数据来确定阻抗相位。随后,可控制驱动信号的频率以最小化或减小所确定阻抗相位与阻抗相位设定点(例如,0°)之间的差值,从而最小化或减小谐波畸变的影响,并相应地提高阻抗相位测量精确度。相位阻抗和频率控制信号的确定可在DSP处理器1074中实现,例如,其中频率控制信号作为输入被提供至逻辑装置1066所实施的DDS控制算法。
在另一个实施例中,例如可监控电流反馈数据,以便将驱动信号的电流幅值保持在电流幅值设定点。电流幅值设定点可直接指定或基于特定的电压幅值和功率设定点而间接地确定。在某些实施例中,例如可通过处理器1074中的控制算法(例如PID控制算法)来实现对电流幅值的控制。控制算法为适当控制驱动信号的电流幅值而控制的变量例如可包括:经由DAC1086对存储于逻辑装置1066和/或DAC1086(其为功率放大器1062提供输入)的足尺输出电压进行标度。
非隔离台1054还可包括第二处理器1090,以用于除别的之外还提供用户界面(UI)功能。在一个实施例中,UI处理器1090可包括例如购自Atmel Corporation(San Jose,CA)的具有ARM926EJ-S核的Atmel AT91SAM9263处理器。UI处理器1090所支持的UI功能的例子可包括听觉和视觉使用者反馈、与外围装置(例如经由通用串行总线(USB)接口)的通信、与脚踏开关1020的通信、与输入装置1009(例如,触摸屏显示器)的通信、以及与输出装置1047(例如,扬声器)的通信。UI处理器1090可与处理器1074和逻辑装置1066(例如经由串行外围接口(SPI)总线)通信。尽管UI处理器1090可主要支持UI功能,然而在某些实施例中,其也可与DSP处理器1074配合以减缓风险。例如,UI处理器1090可被编程为监测使用者输入和/或其他输入(例如,触摸屏输入、脚踏开关1020输入(图17)、温度传感器输入)的各个方面并在检测到错误状况时使发生器1002的驱动输出失效。
在某些实施例中,例如DSP处理器1074与UI处理器1090两者可确定并监测发生器1002的操作状态。对于DSP处理器1074,发生器1002的操作状态例如可指示DSP处理器1074实施的是哪些控制和/或诊断过程。对于UI处理器1090,发生器1002的操作状态例如可指示为使用者呈现用户界面的哪些元素(例如,显示屏、声音)。相应的DSP处理器1074和UI处理器1090可独立地保持发生器1002的当前操作状态并识别和评价当前操作状态的可能转变。DSP处理器1074可用作此关系中的主体并确定何时会发生操作状态间的转变。UI处理器1090可注意到操作状态间的有效转变并可证实特定的转变是否适当。例如,当DSP处理器1074命令UI处理器1090转变至特定状态时,UI处理器1090可证实所要求的转变是有效的。如果UI处理器1090确定所要求的状态间转变是无效的,则UI处理器1090可使发生器1002进入无效模式。
非隔离台1054还可包括控制器1096,以用于监控输入装置1045(例如,用于接通和断开发生器1002的电容触摸传感器、电容触摸屏)。在某些实施例中,控制器1096可包括至少一个处理器和/或与UI处理器1090通信的其他控制装置。在一个实施例中,例如控制器1096可包括处理器(例如,可从Atmel购得的Mega1688位元控制器),所述处理器被配置成监测经由一个或多个电容触摸传感器提供的使用者输入。在一个实施例中,控制器1096可包括触摸屏控制器(例如可从Atmel购得的QT5480触摸屏控制器),以控制和管理从电容触摸屏对触摸数据的采集。
在某些实施例中,当发生器1002处于“功率关”状态时,控制器1096可继续接收操作动力,例如经由线从发生器1002的电源(例如以下所述的电源2011)接收。这样,控制器196可继续监测输入装置1045(例如,位于发生器1002的前面板上的电容触摸传感器),以用于接通和断开发生器1002。当发生器1002处于功率关状态时,如果检测到使用者“接通/断开”输入装置1045的启动,则控制器1096可激活电源(例如,启用电源2011的一个或多个DC/DC电压转换器2013的操作)。控制器1096可因此开始使发生器1002转变至“功率开”状态的序列。相反,当发生器1002处于功率开状态时,如果检测到“接通/断开”输入装置1045的启动,则控制器1096可开始使发生器1002转变至功率关状态的序列。在某些实施例中,例如控制器1096可向处理器1090报告“接通/断开”输入装置1045的启动,所述处理器又会实施所需的过程序列以使发生器1002转变至功率关状态。在此类实施例中,控制器196可能不具有在建立起功率开状态之后从发生器1002移除功率的独立能力。
在某些实施例中,控制器1096可使发生器1002提供听觉或其他感观反馈,以警示使用者功率开或功率关序列已开始。可在功率开或功率关序列开始时以及在与序列相关联的其他过程开始之前提供此类警示。
在某些实施例中,隔离台1052可包括器械接口电路1098,例如以在外科装置的控制电路与非隔离台1054的组件(例如,可编程逻辑装置1066、DSP处理器1074、和/或UI处理器190)之间提供通信界面。器械接口电路1098可经由通信连接装置与非隔离台1054的组件交换信息,所述通信连接装置在台1052,1054之间保持合适程度的电绝缘,并例如为基于红外(IR)的通信连接装置。例如,可使用由隔绝变压器提供动力的低跌落电压调节器为器械接口电路1098提供动力,所述隔绝变压器从非隔离台1054被驱动。
在一个实施例中,器械接口电路198可包括逻辑装置2000(例如,逻辑电路、可编程逻辑电路、PGA、FPGA、PLD)与信号调节电路2002通信。信号调节电路2002可被配置成从逻辑电路2000接收周期性信号(例如,2kHz的方波),以生成具有相同频率的双极性询问信号。例如,可使用由差分放大器馈送的双极性电流源生成询问信号。询问信号可通过通信而被提供至外科装置控制电路(例如,通过使用将发生器102连接至外科装置的缆线中的导电对)并被监控,以确定控制电路的状态或构型。控制电路可包括多个开关、电阻器和/或二极管,以修改询问信号的一个或多个特性(例如,幅值、校正),使得可基于所述一个或多个特性唯一地辨别控制电路的状态或构型。在一个实施例中,例如信号调节电路2002可包括ADC,以用于产生由于询问信号通过控制电路而出现在控制电路输入中的电压信号的样本。随后,逻辑装置2000(或非隔离台的组件1054)可基于ADC样本来确定控制电路的状态或构型。
在一个实施例中,器械接口电路1098可包括第一数据电路接口2004,以实现逻辑电路2000(或器械接口电路1098的其他元件)与设置于外科装置中或以其他方式与外科装置相关联的第一数据电路之间的信息交换。在某些实施例中,例如第一数据电路2006可设置于成一体地附接到外科装置手持件的缆线中,或设置于用于使特定的外科装置类型或模型与发生器1002交接的适配器。在某些实施例中,第一数据电路可包括非易失性存储装置,例如电可擦除的可编程的只读存储器(EEPROM)装置。在某些实施例中,再次参见图19,第一数据电路接口2004可与逻辑装置2000分开地实施并包括合适的电路(例如,离散的逻辑装置、处理器),以实现可编程逻辑装置2000与第一数据电路之间的通信。在其他实施例中,第一数据电路接口2004可与逻辑装置2000形成一体。
在某些实施例中,第一数据电路2006可存储与其相关联的特定外科装置的附属信息。此类信息例如可包括型号、序号、其中使用外科装置的操作数目、和/或其他类型的信息。此种信息可被器械接口电路1098(例如通过逻辑装置2000)读取、被传输至非隔离台1054的组件(例如,逻辑装置1066、DSP处理器1074、和/或UI处理器1090),以经由输出装置1047呈现给使用者和/或控制发生器1002的功能或操作。另外,任何类型的信息均可经由第一数据电路接口2004(例如,使用逻辑装置2000)通过通信而被提供至第一数据电路2006以存储于其中。此类信息例如可包括其中使用外科装置的操作的更新数目和/或其使用的日期和/或时间。
如在前所讨论,外科器械可从手持件拆卸(例如,器械1024可从手持件1016拆卸)以促进器械可互换性和/或可随意处理性。在此类情形中,常规发生器的识别所使用特定器械构型和相应地优化控制和诊断过程的能力可受限。然而,从兼容性角度来看,通过对外科装置器械添加可读数据电路来解决此问题是有问题的。例如,设计外科装置来保持与缺少必备数据读取功能的发生器的向后兼容可能由于例如不同的信号方案、设计复杂性和成本而不切实际。本文所述器械的实施例通过使用数据电路来解决这些问题,所述数据电路可经济地实施于现有外科器械中并产生最小的设计变化,以保持外科装置与当前发生器平台的兼容性。
另外,发生器1002的实施例可实现与基于器械的数据电路的通信。例如,发生器1002可被配置成与外科装置的器械(例如,器械1024或1034)中所包含的第二数据电路进行通信。器械接口电路1098可包括用于实现此种通信的第二数据电路接口2010。在一个实施例中,第二数据电路接口2010可包括三态数字接口,然而也可使用其他接口。在某些实施例中,第二数据电路通常可为用于传输和/或接收数据的任何电路。在一个实施例中,例如第二数据电路可存储与其相关联的特定外科器械的附属信息。此类信息例如可包括型号、序号、其中使用外科器械的操作数目、和/或其他类型的信息。除此之外或作为另外一种选择,任何类型的信息均可经由第二数据电路接口2010(例如,使用逻辑装置2000)通过通信提供至第二数据电路以存储于其中。此类信息例如可包括其中使用外科器械的操作的更新数目和/或其使用的日期和/或时间。在某些实施例中,第二数据电路可传输由一个或多个传感器(例如,基于器械的温度传感器)采集的数据。在某些实施例中,第二数据电路可从发生器1002接收数据并基于所接收的数据向使用者提供指示(例如LED指示或其他可视指示)。
在某些实施例中,第二数据电路和第二数据电路接口2010可被配置成使得可实现逻辑装置2000与第二数据电路之间的通信而无需为此提供附加的导体(例如,将手持件连接至发生器1002的缆线的专用导体)。在一个实施例中,例如可使用实施于现有缆线(例如,用于将询问信号从信号调节电路2002传输至手持件中的控制电路的其中一个导体)上的单总线通信方案而使信息以通信方式到达和离开第二数据电路。这样,可最小化或减少原本可能必要的外科装置的设计变化或修改。此外,因为在共用物理通道上实施的不同类型的通信可为频带分离的,所以第二数据电路的存在对于不具有必备数据读取功能的发生器而言可为“隐形的”,因此能够实现外科装置器械的向后兼容性。
在某些实施例中,隔离台1052可包括至少一个阻挡电容器2096-1,所述至少一个阻挡电容器2096-1连接至驱动信号输出1060b以防止DC电流流向患者。例如,可要求信号阻挡电容器符合医疗规则或标准。尽管相对而言单电容器设计中很少出现错误,然而此类错误可造成不良后果。在一个实施例中,可设置有与阻挡电容器2096-1串联的第二阻挡电容器2096-2,其中例如通过ADC2098来监测从阻挡电容器2096-1与2096-2之间的点发生的电流泄漏,以对泄漏电流所感应的电压进行采样。这些样本例如可由逻辑电路2000接收。基于泄漏电流的变化(如图19的实施例中的电压样本所指示),发生器1002可确定阻挡电容器2096-1,2096-2至少其中之一何时失效。因此,图19的实施例提供相对于具有单个失效点的单个电容器设计的优势。
在某些实施例中,非隔离台1054可包括电源2011,以用于在适当的电压和电流下输出DC电力。电源可包括例如400W的电源以用于输出48VDC的系统电压。电源2011还可包括一个或多个DC/DC电压转换器2013,所述一个或多个DC/DC电压转换器用于接收电源的输出以在发生器1002的各种组件所需的电压和电流下产生DC输出。如以上结合控制器1096所述,当控制器1096检测到使用者“接通/断开”输入装置1045的启动时,DC/DC电压转换器2013中的一个或多个可从控制器1096接收输入,以启用DC/DC电压转换器2013的操作或将DC/DC电压转换器2013激活。
已描述了外科系统19(图1),190(图10),1000(图16)的各种实施例的操作细节,可就采用包括输入装置406,1009和发生器1002的外科器械切割和凝固组织的过程进一步大致描述以上外科系统19,190,1000的操作。尽管结合操作细节描述了特定方法,然而应当理解,所述方法仅提供如何通过外科系统19,190,1000中的任一者实施本文所述的一般功能性的例子。此外,除非另外指明,否则给定的方法不一定按照本文展现的次序执行。如在前所讨论,可采用输入装置406,1009中的任一者来编程外科装置100(图1),120(图10),1002(图16),1006(图16)的输出(例如,阻抗、电流、电压、频率)。
图20-22示出与用于检测何时发生超声端部执行器1026刀片的快速发热的组织算法相关的逻辑流程图1200,1300,1400的各种实施例,并提供经由输出指示器412(图9,11)和/或输出装置1047(图16)进行响应的机会(例如,对功率输出的通知、调制和/或对内容的显示)。根据本公开,当使用多个参考编号描述一元件(例如,“超声外科器械100,120,1004”)时,应当理解,这是指所述元件中的任一者,例如,“超声外科器械100”、或“超声外科器械120”、或“超声外科器械1004”。
在各种实施例中,可通过图9和图11所示的输出指示器412或图16中的输出装置1047提供反馈。这些反馈装置(例如,输出指示器412、输出装置1047)尤其适用于其中由端部执行器81(图1),810(图10),1026(图16)操纵的组织在使用者的视野之外且当组织中发生状态变化时使用者无法看到的应用。反馈装置与使用者通信以告知使用者,根据参照与相应组织算法相关的逻辑流程图700,800,900,1200,1300,1400所述的操作所确定,已发生组织状态变化。反馈装置可被配置成根据组织的当前状态或条件来提供各种类型的反馈。可根据参照以上结合图15A-C所述逻辑流程图700,800,900以及以下结合图20-22所述逻辑流程图1200,1300,1400所述的操作基于换能器和组织测量值基于电压、电流和频率测量值来确定组织的状态变化。
在一个实施例中,逻辑流程图1200,1300,1400可被实施成可执行模块(例如,算法),其包括将被发生器30,500的处理器400(图9,11,14)部分或发生器1002(图16,17,19)执行的计算机可读指令。在各种实施例中,参照逻辑流程图1200,1300,1400所述的操作可被实施成:一个或多于一个软件组件,例如,程序、子程序、逻辑;一个或多于一个硬件组件,例如,处理器、DSP、PLD、PGA、FPGA、ASIC、电路、逻辑电路、寄存器;和/或软件与硬件的组合。在一个实施例中,用于执行逻辑流程图1200,1300,1400所述的操作的可执行指令可被存储在存储器中。指令在被执行时会使处理器400、DSP处理器1074(图19)或逻辑装置1066(图19)根据逻辑流程图1200,1300和1400中所述的操作确定组织状态的变化并通过输出指示器412(图9,11)或输出指示器1047(图16,17)为使用者提供反馈。根据这些可执行指令,处理器400、DSP处理器1074、和/或逻辑装置1066监测并评价可从发生器30,500,1002获得的电压、电流、和/或频率信号样本并根据对这些信号样本的评价来判断是否发生组织状态变化。如以下的进一步描述,组织状态的变化可基于超声器械的类型和激发所述器械的功率电平来确定。响应于所述反馈,超声外科器械100,120,1004中任一者的操作模式可由使用者控制,或者可自动或半自动地被控制。
现在将结合由相应发生器30(图1),500(图10),1002(图17)驱动的超声外科器械100,120,1004中的任一者来描述逻辑流程图1200,1300,1400所表示的组织算法的发明内容。在一个方面,组织算法检测超声端部执行器81(图1),810(图10),1026(图17)的刀片部分的温度(以及因此发生的谐振)何时快速改变(最感兴趣的是增大的改变)。对于夹持或剪刀型器械,当很少甚至没有组织、组织碎屑、或流体邻近刀片且刀片抵靠夹持臂、夹持垫或其他合适的组织偏置构件而被启动时,除其他之外,此种改变还可对应于共同的临床场景。对于其中使用具有或不具有夹持臂和相关机构的器械来对组织进行作用的非夹持型应用,此种改变对应于发生快速发热的条件(例如,当刀片抵靠骨或其他硬的材料被启动时,或当使用过大的力将刀片联接到靶组织时)。这些是例证性情形;可设想其中可发生快速刀片发热并且此处所述的此类组织算法有利的其他临床场景。
逻辑流程图1200,1300,1400所代表的组织算法可结合以下中的任一者采用:本文所述的发生器30,500,1002;其他合适的发生器,例如Ethicon Endo-Surgery,Inc.(Cincinnati,Ohio)出售的GEN04、GEN11发生器;以及可支持本文所公开的算法或技术的相关装置、系统。因此,在结合流程图1200,1300,1400描述组织算法时,参照结合对应的图1-9、图10-13和图16-19所述的发生器30,500,1002。
因此,现在参照图1-14,超声外科器械100,120,1004中的任一者的刀片/手持件谐振系统的频率均取决于温度。例如,当超声剪刀型端部执行器切穿组织的被夹持部分时,刀片会加热并切薄组织,直至其最终切穿组织为止。此时,刀片抵靠组织垫而停留,如果两者之间保持有夹持压力,则刀片与垫界面会通过刀片相对于垫的机械或振动运动来获取功率。当垫材料完全绝缘时,“保存”在接口处的功率会被大量地传导至刀片末端中。此种热能改变刀片末端的刚度,并且系统谐振会由于这些局部(至末端)的条件而相应地改变。发生器30,500,1002跟踪此种谐振。剪刀例子示出使用算法的一种场景。其他的场景为使用夹持臂闭合的剪切装置进行回切、刀片切割结实的或硬的组织、或其中已知需要刀片端部执行器的热状态的任何场景。现在结合图20-22中的逻辑流程图1200,1300,1400描述对此种谐振追踪以及因此对刀片末端热状态施加逻辑的组织算法。
另外,通过使用本文所述包括对应发生器30,500,1002的超声手术器械100,120,1004中的任一者所获取的数据,结合逻辑流程图1200,1300,1400所述的组织算法的说明可带有例证性例子。
结合逻辑流程图1200,1300,1400所述的组织算法依赖于对电驱动信号、尤其是与驱动信号的谐振频率相关的电驱动信号的监测。算法监测谐振频率及其随时间的变化(即,频率相对于时间的一阶导数)。在本公开通篇中,此种随时间的频率变化被称为频率斜率。通过以下方式在局部计算(根据时间透视图)频率斜率:计算相邻(或相对接近)的数据点的频率变化并以对应的时间变化进行划分。由于信号瞬变,可采用平均或多种适用的滤波或平滑技术中的任一种(使得可更容易地识别趋势并迅速防止接通/断开条件集合)。图62,63,64所示的数据图示出频率斜率的计算以及平均技术(例如,指数加权移动平均方法或EWMA)的使用,所述平均方法用于获取适用于控制/监测的频率斜率值。频率斜率的其他说明可包括但不限于“频率的一阶导数”和“频率相对于时间的变化”。
图20是可在发生器30,500,1002的一个实施例中实施的组织算法的逻辑流程图1200。在大体水平上,结合逻辑流程图1200所述的组织算法针对与所关注事件(例如,超声器械的刀片迅速发热)相关的逻辑条件集合实时评价电信号。因此,发生器30,500,1002确定何时发生逻辑条件集合并触发对应的响应集合。术语“条件集合”和“响应集合”定义如下:
(1)条件集合–实时监测电信号的逻辑条件集合。
(2)响应集合–发生器30,500,1002系统对已满足的条件集合作出的一个或多个响应。
在1202处,发生器30,500,1002以准备就绪的状态被放置成超声驱动模式。
在1204处,发生器30,500,1002在预定的功率电平N下被启动。当使用者启动外科系统19,190,1000时,对应的发生器30,500,1002通过以下方式进行响应:查找外科系统19,190,1000谐振,并随后使对端部执行器81,810,1026的输出斜升至所命令功率电平的目标水平。
在1206处,组织算法通过确定何时启用至少一个条件集合/响应集合标记来判断与组织算法相关联的参数是否在使用中。当未启用此类标记时,算法沿“否”路径继续进行,其中在1208处外科系统19,190,1000以正常的超声模式操作,并且在1210处,当组织手术完成时对应的发生器30,500,1002失效。
当用于设定条件集合/响应集合的至少一个标记被启用时,算法沿“是”路径继续进行,并且发生器30,500,1002在使定时器X和定时器X闩锁复位之后利用组织算法1300信号评价。在一个实施例中,用于设定条件集合/响应集合的至少一个标记被存储于附接到相应发生器30,500,1002的器械100,120,1004的EEPROM图像中。用于将条件集合/响应集合设定到启用状态的EEPROM标记包含于表1中。
表1
在一个实施例中,逻辑流程图1200的组织算法1300信号评价部分利用两个条件集合,并且所述两个条件集合的每一者均具有响应集合,将结合逻辑流程图1300,1400更详细地描述所述响应集合。组织算法1300逻辑可被示出如下:当满足条件集合1时,触发响应集合1。具有两个条件集合能够实现分层响应(基于条件水平的差分响应)并且也提供管理复杂时间序列的能力。
在1210处,触发针对所满足条件集合的响应。在1214处,重复循环1212,直至满足条件集合且发生器30,500,1002失效为止。
脉冲响应比相对简单的听觉和LCD显示响应更详细并需要进一步解释。当脉冲响应被触发时,发生器30,500,1002驱动如以下四个参数所限定的脉冲输出:
(1)第一脉冲振幅(EEPROM参数,针对每一功率电平具有一个值)–第一脉冲的驱动幅值;
(2)第一脉冲时间(EEPROM参数)–第一脉冲振幅被驱动的时间;
(3)第二脉冲振幅(EEPROM参数,针对每一功率电平具有一个值)–第二脉冲的驱动幅值;以及
(4)第二脉冲时间(EEPROM参数)–第二脉冲振幅被驱动的时间。
当驱动脉冲输出时,发生器30,500,1002驱动第一脉冲随后驱动第二脉冲,并重复此过程。脉冲振幅可按如下单位表达:命令功率电平的输出电流的百分比。当MIN被激活时,命令功率电平可通过启动开关(MIN或MAX)和发生器设定来设定。
图21是图20所示组织算法的可在发生器的一个实施例中实施的信号评价组织算法部分的逻辑流程图1300。图21所示的组织算法信号评价流程显示“等待时间”参数1304的应用和频率斜率(因其为运行中的计算,故也被称为局部频率斜率)的计算。
在1302处,算法计算自1204(图20)处开始启动以来的时间。此时间被表达成TElapse,等于TSytem–TPowerOn。如在前所讨论,当使用者启动外科系统19,190,1000时,对应的发生器30,500,1002通过以下方式进行响应:查找外科系统100,120,1004的谐振,并随后使对端部执行器81,810,1026的输出斜升至命令功率电平的目标水平。
在此期间,先关联的信号瞬变可使算法逻辑的施加变得困难。因此,算法利用“等待时间”参数1304,所述“等待时间”参数存储于位于超声外科器械100,120,1004的手持件部分中的EEPROM图像中。“等待时间”参数1304(EEPROM参数)被定义为启动开始时的时间,在此期间发生器30,500,1002不施加组织算法,以减轻谐振查找和驱动斜升信号瞬变对算法逻辑的影响。典型的“等待时间”参数1304值约为0.050秒至0.600秒(50至600毫秒)。
在1306处TElapse与“等待时间”参数1304的值进行比较。当TElapse小于或等于“等待时间”参数1304的值时,算法沿“否”路径继续进行,以在1302处计算新的TElapse。当TElapse大于“等待时间”参数1304的值时,算法沿“是”路径继续进行以平价信号。
在1308处,算法执行信号评价/监测功能。如在前所述,函数算法的一个方面是监测频率斜率。在物理意义上,频率斜率与进入或离开包括刀片和手持件听觉子组件的谐振系统(例如本文所述的超声系统100,120,1004)的热通量相关,在组织上启动的过程中频率和频率斜率的变化由端部执行器处所发生的变化状态(组织变干、分离以及刀片接触夹持臂垫)支配。当刀片发热(即,热通量进入刀片)时,频率斜率是负的。当刀片冷却(即,热通量离开刀片)时,频率斜率是正的。因此,算法计算各频率数据点(即,即将产生的频率数据点1310(Ft)与在前Ft数据点1312之间的斜率。计算所得的频率斜率也可被称为局部频率斜率,这是因为其为运行中的计算。局部频率斜率可被称为FSlope_Freq,Ft,其为谐振频率(Ft)下的频率斜率(FSlope_Freq)。局部频率斜率例如可按路线被发送至条件集合1、条件集合21400,以根据图22所示的流程图1400进行评价。
图22是可在发生器的一个实施例中实施的逻辑流程图1400,所述逻辑流程图用于评价用于图21所示信号评价组织算法的条件集合。逻辑流程图1400评价条件集合X,例如,其中X是1或2。
根据组织算法,在1402处,在1308(图21)处将计算所得的局部频率斜率与功率电平N下的条件集合X的频率斜率阈值参数1404的值进行比较。频率斜率阈值参数1404可存储于位于附接器械100,120,1004中的EEPROM中,其中针对每一功率电平存储一个EEPROM参数值。当在1308处计算所得的局部频率斜率降至低于频率斜率阈值参数1404的值时,可在1210(图20)处触发第一响应集合。当刀片以相对快的速率发热时,频率斜率将变得更负,并且组织算法通过降至低于频率斜率阈值参数1404的值的频率斜率来识别此种状态。此外,频率斜率指示热变化或热通量进入或离开刀片的速率。
根据组织算法,同样在1402处,将谐振频率与条件集合X的频率阈值参数1406的值进行比较。频率阈值参数1406的值可存储于位于附接器械100,120,1004中的EEPROM中。当谐振频率降至低于阈值频率参数1406的值时,在1210(图20)处触发第二响应集合。当刀片继续发热时,频率会继续下降。频率阈值参数1406的值旨在通过提供与刀片的热状态相关的额外信息(除更加动态的指示器、频率斜率之外)来提高算法稳健性。从某一已知条件(例如室温)开始的频率下降能够良好地指示谐振系统相对于这些已知热条件的的热状态。
在1402,当频率斜率(FSlope_Freq)小于频率斜率阈值参数1404的值且谐振频率(Ft)小于频率阈值参数1406的值时,算法沿“是”路径继续进行至1408,以使计时器X(其中X对应于组织算法所评价的特定条件集合)递增。
在比较电信号,例如频率斜率(FSlope_Freq)和谐振频率(Ft)与相应的阈值参数1404,1406时,可如下将信号来回弹跳超过阈值的边界线条件纳入考虑中。在一个方面,组织算法采用用于特定条件集合X的“触发前所需时间”参数1412的值(其也可被存储在器械EEPROM中)以对此种考虑因素作出解释。“触发前所需时间”参数1412的值被定义成触发之前所需的时间(EEPROM参数)–频率斜率和/或频率小于其欲被触发的响应集合的相应阈值所需的时间。这旨在防止响应的快速“来回”触发。然而,跟踪可能发生的非迅速“来回”触发可为有用的。
因此,在1414,算法判断定时器X的值是否大于条件集合X的“触发前所需时间”参数1412的值。当定时器X的值大于“触发前所需时间”参数1412的值时,算法沿“是”路径继续进行,以在1416处设定用于条件集合X的闩锁。输出1418指示满足条件集合X。当定时器X的值小于或等于“触发前所需时间”参数1412的值时,算法沿“否”路径继续进行,以在输出1420处指示不满足条件集合X。
在1402,当频率斜率(FSlope_Freq)大于或等于频率斜率阈值参数1404的值或谐振频率(Ft)大于或等于频率阈值参数1406的值时,算法沿“否”路径继续进行,以在1410复位定时器X(其中X对应于组织算法所评价的特定条件集合)。
为实现附加的稳健性,算法采用两个闩锁参数。在不使用闩锁时,算法被配置成当(a)系统失效时或(b)当一个或多个信号不再低于其相应阈值时结束响应集合。可利用两个闩锁参数。其为“最小闩锁时间”参数1422和“跨回频率斜率阈值”参数1424。这些闩锁参数1422,1424对于围绕以下的稳健性是重要的:(a)随着温度升高而变得更加光滑的夹持臂垫表面;以及(b)其中预期在脉冲转变处发生信号瞬变的脉冲输出。
最小闩锁时间参数1422(EEPROM参数)可被定义成对欲触发条件集合X的最小响应时间量。最小闩锁时间的考虑因素包括:(a)播放所触发的听觉响应所需的时间长度(例如,在一个实施例中,“预警示”WAV听觉文件可为约0.5秒长),(b)针对事件的典型(约0.5秒至1.0秒)或极端(约1.5秒至2.0秒)使用者响应时间,或(c)多切割(被称为“前进”)应用的典型组织再次抓紧时间(约1.1秒–2.0秒,平均值为约1.6秒)。
跨回频率斜率阈值参数1424(EEPROM参数)可被定义成超过后所触发的响应会停止(即,不再被触发)的频率斜率阈值。此会提供更高的“跨回超过”频率斜率阈值,所述阈值通过区分是抵靠垫还是抵靠打开的钳口启动(相对于区分是在组织上启动还是在垫上启动)被分配。
根据逻辑流程图1400所代表的组织算法部分,在定时器X在1410处被复位之后,在1426,组织算法判断是用于条件集合X的闩锁还是跨回频率斜率闩锁被设定。当两个闩锁均未被设定时,算法沿“否”继续进行,以在输出1420处指示不满足条件集合X。当闩锁的其中任一者被设定时,算法沿“是”路径继续进行至1428。
在1428,算法判断条件集合X的闩锁时间是否大于条件集合X的最小闩锁时间参数1422的值,并且频率斜率(FSlope_Freq)是否大于跨回频率斜率阈值参数1424的值,算法沿“是”路径继续进行,以在1430处复位定时器X的闩锁并在输出1420处指示不满足条件集合X。当条件集合X的闩锁时间小于或等于条件集合X的最小闩锁时间参数1422的值,并且频率斜率(FSlope_Freq)小于或等于跨回频率斜率阈值参数1424的值时,算法沿“否”路径继续进行,以在输出1432处指示满足条件集合X。
如图21和图22所示,存在来自流程透视图的两个相同条件集合1和2。条件集合1和2具有如表2中所包含的重复参数集合。条件集合1和2所共享的算法参数包含在表3中。
表2包含每一条件集合的重复算法EEPROM参数和每一条件集合的数字参数的总结。
表2:算法EEPROM参数总结,每一条件集合的重复参数
每一条件集合的重复参数 | 每一条件集合参数的号 |
触发前所需时间 | 1 |
最小闩锁时间 | 1 |
频率斜率阈值(每一功率电平有一个) | 5 |
频率阈值 | 1 |
表3包含每一条件集合的共享算法EEPROM参数(不重复)和数字参数的总结。
表3:算法EEPROM参数总结,所有条件集合的共同参数
条件集合所共享的参数(不重复) | 参数的号 |
等待时间 | 1 |
跨回频率斜率阈值 | 1 |
第一脉冲振幅(每一功率电平有一个) | 5 |
第一脉冲时间 | 1 |
第二脉冲振幅(每一功率电平有一个) | 5 |
第二脉冲时间 | 1 |
为清楚说明本公开,现在将以四个例子来描述结合相应的图20-22所示的逻辑流程图1200,1300,1400所述的组织算法。组织算法的基本应用包括针对相应的阈值监测频率斜率、谐振频率、或两者。因此,第一例子包括针对相应的阈值监测频率斜率且被示出于图23-28中。第二例子包括针对相应的阈值监测谐振频率且被示出于图29-31中。第三例子包括针对相应的阈值监测频率斜率和谐振频率两者且被示出于图32-34中。最后,第四例子也包括针对相应的阈值监测频率斜率和谐振频率两者。
实例1:针对相应的阈值监测频率斜率
第一例子情形包括针对相应的阈值监测频率斜率并结合图23-28被示出。最简单的第一例子是仅基于频率斜率触发响应集合的例子。表4包含为此目的用于外科器械的代表参数,所述外科器械例如为本文所公开的包括对应超声器械(例如,本文所公开的超声器械100,120,1004)的外科器械19,190,1000中的任一者。
表4:用于仅基于频率斜率阈值(利用一个条件集合)来触发听觉指示的代表参数
*这些参数值被设定成适当的极端值,使得其不会有效地参与到逻辑流程中(例如,被设定成始终为“真”)。
图23-25显示发生器所产生的信号数据,其中代表性/例证性参数包含在表4中。发生器可类似于本文所公开的发生器30,500,1002中的任一者,其形成根据本公开施加于组织上的以超声模式操作的相应外科系统19,190,1000(例如,超声系统19,190,1000)的一部分。
“老化”场景或测试中可进一步显示仅使用频率斜率来触发响应集合。图26-28显示在“老化”场景或测试期间发生器所产生的信号数据,其中代表性/例证性参数包含在表4中。“老化”模拟其中使用者在未介入组织的情况下启动剪刀型超声外科器械(例如,在钳口闭合的情况下进行回切)的使用情形。例如,此种测试也可适用于量化装置特性(例如“响应时间”)。
超声器械的响应时间可被定义成超声系统(器械、手持件、和带有组织算法的发生器)对夹持臂垫接触刀片作出响应所需的时间。超声系统通常最初以“空中”(即,无负载)形式被启动,夹持臂抵靠刀片而闭合并保持一段时间,随后夹持臂打开且超声系统失效。响应时间是静态功率(空中功率)由于夹持臂垫开始接触刀片而开始改变的点与响应集合被触发的点之间的时间。这也是能够实现冷却速率量化的测试—冷却速率越高(假设相似的对流边界条件),刀片中的热能或残余热量越多。冷却速率与频率斜率成正比(以增强:正的频率斜率值与离开刀片的瞬时热通量相关)。下文将详细描述,冷却速率也可被监测并用于控制目的,使得例如如果由正的频率斜率限定的冷却速率大于阈值,则得知刀片“携载”大量的热能并在迅速散热。
图23是发生器的一个实施例在典型的组织切割过程中的频率斜率与时间的关系波形1502的图示1500。对于使用包括设定在功率电平5上的对应超声外科器械的超声系统中的任一者所进行的典型组织切割,频率斜率(kHz/s)沿垂直轴线显示,并且时间(秒)沿水平轴线显示。用于此种应用的频率斜率阈值1504为-0.06kHz/s并通过水平虚线显示。垂直虚线1506显示组织开始分离的时间(2.32秒),并且所述垂直虚线1508显示超声系统触发响应集合(在此种情形中,依照表4,仅听觉声音)的时间(2.55秒)。
图23A是发生器的一个实施例在典型的组织切割过程中频率的二阶时间导数(频率斜率的斜率)与时间的关系波形1503(显示为虚线)的图示,该波形被添加在图23所示的波形1502上。
图24是发生器的一个实施例在典型的组织切割过程中在涉及图23所示图示1500时的频率与时间的关系波形1512的图示1510。对于使用设定在功率电平5上的超声系统中的任一者所进行的典型组织切割,谐振频率(kHz)沿垂直轴线显示,并且时间(秒)沿水平轴线显示。垂直虚线1506显示组织开始分离的时间(2.32秒),并且垂直虚线1508显示超声系统触发响应集合(在此种情形中,仅听觉声音)的时间(2.55秒)。
图25是发生器的一个实施例在典型的组织切割过程中在涉及图23所示图示1500时的功耗与时间的关系波形1514的图示1514。对于使用设定在功率电平5上的超声系统中的任一者所进行的典型组织切割,功率(W)沿垂直轴线显示,并且时间(秒)沿水平轴线显示。垂直虚线1506显示组织开始分离的时间(2.32秒),并且垂直虚线1508显示超声系统触发响应集合(在此种情形中,仅听觉声音)的时间(2.55秒)。
图26是发生器的一个实施例在老化测试过程中的频率斜率与时间的关系波形1518的图示1516。用于此种测试的参数与表4中所包含的参数一致。对于使用设定在功率电平5上的超声系统中的任一者所进行的典型组织切割,频率斜率(kHz/s)沿垂直轴线显示,并且时间(秒)沿水平轴线显示。用于此种应用的频率斜率阈值1504为-0.06kHz/s,如水平虚线所示。垂直虚线1524显示静态功率由于夹持而开始改变的时间点(2.49秒),垂直虚线1506显示功率已完成斜升的时间(2.66秒),并且垂直虚线1508显示超声系统触发响应集合(在此种情形中仅听觉声音)的时间(2.72秒)。如图示1516所示,频率斜率在1520处与刀片的冷却速率或热通量离开刀片的速率相关。此外,超声系统的响应时间1522被测量为在静态功率由于夹持而开始改变的时间点(2.49秒)与超声系统触发响应集合的时间(2.72秒)之间的时间流逝。
图27是发生器的一个实施例在老化测试过程中在涉及图26所示图示1516时的频率与时间的关系波形1526的图示1524。对于使用设定在功率电平5上的超声系统中的任一者所进行的典型组织切割,谐振频率(kHz)沿垂直轴线显示,并且时间(秒)沿水平轴线显示。
图28是发生器的一个实施例在老化测试过程中在涉及图26所示图示1516时的功耗与时间的关系波形1530的图示1528。对于使用设定在功率电平5上的超声系统中的任一者所进行的典型组织切割,功率(W)沿垂直轴线显示,并且时间(秒)沿水平轴线显示。
实例2:仅基于频率阈值触发响应集合
参照图29-35,第二实例情形包括仅基于频率阈值触发响应集合。表5包含为此目的结合外科器械的代表参数,所述外科器械例如为本文所公开的包括对应超声器械(例如,本文所公开的超声器械100,120,1004)的外科器械19,190,1000中的任一者。应当理解,由于对动态端部执行器状态的表征性较低,因此经由频率阈值进行触发的实用性可受限,而且是为了本公开的完整性而被呈现于本文中。在结合逻辑流程图1200,1300,1400所述的组织算法中包含频率斜率是旨在与本说明书的下一章节中所论及的逻辑(与频率斜率阈值的使用相结合)结合使用。
表5:用于仅基于频率阈值(利用一个条件集合)来触发听觉指示的代表参数
*这些参数值被设定成适当的极端值,使得其不会有效地参与到逻辑流程中(例如,被设定成始终为“真”)
图29-34显示发生器所产生的波形,其中代表性/例证性参数包含在表5中。发生器可类似于本文所公开的发生器30,500,1002中的任一者,其形成根据本公开施加于组织上的以超声模式操作的相应外科系统19,190,1000(例如,超声系统19,190,1000)的一部分。
在表5中是基于以下两种不利情形的测试数据而选择55,100Hz作为频率阈值:(1)其中在很长一段时间内抵靠组织垫启动超声器械;以及(2)其中使用超声器械尽可能快地连续10次切割离体的猪空肠组织并同时保持发生器自始至终地运行。以下将分别参照图29和图30-图31A-C来更详细地论述这两种不利情形中的每一者。
图29是多个发生器在老化测试过程中的波形随时间的频率变化1602的图示1600。在老化X秒后发生的频率变化(kHz)沿垂直轴线显示,并且超声外科器械装置编号沿水平轴线显示。图29显示在超声外科器械的延长老化之后的频率变化数据,其中超声外科器械是在很长一段时间内抵靠组织垫而被致动(延长老化)。55,100Hz的选择将此种状况限制于不超过4秒的时间跨度或从55,800Hz的标称室温谐振频率开始的约700Hz的频率下降。在对应的1,2,3,和4秒处将频率变化数据16021,16022,16023,16024从发生器30,500,1002数据提取到老化中。五个超声外科器械的标称起始频率是55.8kHz(刀片从室温开始)。第二和第五装置未运行足够长的时间来产生所有时间的完整数据集合。
图30是发生器的一个实施例的归一化组合阻抗、电流、和频率与时间的关系波形以及该实施例的功耗、所提供能量、和温度的图示1604,所述发生器联接到对应的超声器械,所述超声器械用于尽可能快地连续10次切割组织(例如,离体的猪空肠组织)并同时保持发生器贯穿整个过程而运行。用于获得此图示的此种数据和方法表示不利使用条件。
结合图31A-C更清楚地显示图30中的代表数据。图31A是在一段时间内进行连续组织切割过程中发生器的一个实施例的阻抗与时间的关系波形1608以及电流与时间的关系波形1610的图示1606。阻抗(Ω)和电流(mA)沿垂直轴线显示,并且时间(秒)沿水平轴线显示。
图31B是发生器的一个实施例在一段时间内进行连续组织切割过程中信号的谐振频率波形1614与时间的关系的图示1612。谐振频率(kHz)沿垂直轴线显示,并且时间(秒)沿水平轴线显示。
图31C是发生器的一个实施例在一段时间内进行连续组织切割过程中功率波形1618、能量波形1620、和温度波形1622与时间的关系的图示1616。功率(W)、能量(J)、温度(C)沿水平轴线显示,并且时间(秒)沿水平轴线显示。
因此,现在参照图31A-C,如图示1612所示,可看出谐振频率曲线1614在1615处进行第三次切割(此为尤其不利的切割)时降低700Hz(从55.8kHz降至55.1kHz)之后,其中组织在末端被加负载。在谐振频率波形1614进行第三次切割时降低700Hz(从55.8kHz降至55.1kHz)之后,超声器械开始使发生器饱和,并且电流波形1610在所有连续切割中略微下降。由于驱动电流波形1610与刀片末端位移成正比,因此下降的电流波形1610使对组织进行作用的速度更慢并因此使能量沉积速率更低(且发热速率更低,即,频率斜率增大而变为较小的负值)。由于应用序列内具有下降的电流波形1610,因此可使用频率变化和频率斜率变化来实现对此种变化的管控,如在本说明书后续章节中结合实例3和4所述。
图32是由与本文所述发生器的一个实施例相似的发生器所产生的频率波形1632、加权频率斜率波形1634(经由α值为0.1的指数加权移动平均方法计算得出)、和温度波形1636与时间的关系的组合图示1630。超声系统具有室温谐振频率(纵向模式),该频率稍高于表5所构建的频率。因此,频率阈值1633相应地从表5所示的55,100Hz增大至图33中的虚线所示的约55,200Hz。使用被设定在功率电平5上的具有约55.9kHz的室温谐振的超声系统对组织(例如,离体的猪空肠组织)进行激活。组织分离发生在6.25秒处;在约8秒处,组织的一侧与刀片分离;且在约10秒处发生完全分离。图33是发生器30,500,1002的一个实施例的频率与时间的关系波形1632的图示。频率(kHz)沿垂直轴线显示,并且时间(秒)沿水平轴线显示。图33显示使用频率阈值1633的实例,所述频率阈值仅使用与表5所示参数一致但如虚线1633所示被调节至约55,200Hz的参数。谐振频率1632在约11秒处跨过频率阈值1633(水平虚线-被设定成比室温谐振低700Hz),并且响应集合可在此时被触发。
图34是发生器的一个实施例的加权频率斜率与时间的关系波形1634的图示1634。加权频率斜率(kHz/s)沿垂直轴线显示,并且时间(秒)沿水平轴线显示。频率斜率波形1634是经由α值为0.1的指数加权移动平均方法计算得出。在图34中,频率斜率波形1634在约5.8秒处跨过频率斜率阈值1635(水平虚线)且响应集合可在此时被触发。
剩余的实例3和4涉及多个条件集合的使用,所述多个条件集合的使用需要更复杂地施用组织算法,并且包括针对相应的阈值监测频率斜率和/或频率,并可包括用于触发响应集合的分层方法。
实例3:基于频率斜率阈值和频率阈值两者触发响应集合
第三实例情形包括基于频率斜率阈值和频率阈值两者触发响应集合。表6包含为此目的结合外科器械的代表参数,所述外科器械例如为本文所公开的包括对应超声器械(例如,本文所公开的超声器械100,120,1004)的外科器械19,190,1000中的任一者。
表6:用于通过频率斜率阈值和频率阈值(利用两个条件集合)触发听觉指示的代
表参数
*这些参数值被设定成适当的极端值,使得其不会有效地参与到逻辑流程中(例如,被设定成始终为“真”)
在实例3的此种情形中,展现层列式或分层响应。将利用图32-34所示的图示来示出频率斜率阈值与频率阈值的组合逻辑。在图34中,条件集合1是由在约6秒处跨过频率斜率阈值1635的频率斜率波形1634触发。条件集合1的响应集合例如可包括低电平的听觉指示器。当使用者继续在具有最小介于中间的组织的情况下启动器械时,当谐振频率在约11秒处降至低于频率阈值1633时(如图33所示)条件集合2被触发。条件集合2的响应集合例如可为提高的听觉指示器。
实例4:基于频率斜率阈值和频率阈值两者触发响应集合
第四实例扩展至在外科器械的不利状态期间对频率阈值和频率斜率阈值的应用。出于各种原因,通过扩展应用可使频率斜率信号电平减小(即,增大而变为更小的负值)。
在不利的状态中,当超声器械恒定地以功率电平5被启动时,可产生偏离正常操作的频率、频率斜率、和电流波形,其中超声器械的钳口打开1秒并接着闭合1秒,并且此循环重复17次。
当超声器械多次直接抵靠垫被启动时,位于发生器饱和之前的第一区域中的特征频率斜率波形比位于发生器饱和后的第二区域中的特征频率斜率波形更大而负值更小,这在很大程度上起因于系统效率并会引起位移/电流降低。在频率斜率波形的非饱和区域中,超声系统尚未饱和且电流被保持为功率电平5的目标电流或接近所述目标电流。在频率斜率波形的饱和区域中,电流(以及(因此)刀片末端位移)持续降低,使得频率斜率增大(发热速率降低)。应注意,在多个不利循环之后,在例如第四不利循环(其为非饱和区域与饱和区域之间的近似分界线)处,谐振频率与图29-图31A-C一致地降低。可对非饱和区域和饱和区域的每一者应用分开的条件集合。当谐振频率状态高于预定频率阈值时,可在非饱和区域中采用第一频率斜率阈值,并且当谐振频率状态低于同一预定频率阈值时,可在饱和区域中采用第二负值更小的频率斜率阈值。
加权频率斜率(kHz/s)与时间的关系波形可为发生器的一个实施例。当在不利条件下抵靠垫使用器械时,非饱和区域中的特征频率斜率波形比饱和区域中的特征频率斜率波形变得负值更小,这起因于材料软化和相应的垫摩擦系数的减小。频率斜率波形的非饱和区域对应于组织垫尚未开始显著发热的时间。在频率斜率波形的饱和区域中,垫开始软化,并且刀片与垫之间的界面变得更润滑,从而使频率斜率波形上升(发热速率降低)。可针对非饱和区域和饱和区域的每一者保证分开的条件集合。当谐振频率状态高于预定频率斜率阈值时,可在非饱和区域中采用第一频率斜率阈值,并且当谐振频率低于同一预定频率斜率阈值时,可在饱和区域中采用第二负值更小的频率斜率阈值。
现在考虑另一实例情形。表7包含用于超声器械的参数,其中使用两个条件集合解释由于系统饱和以及降低的电流而减小的频率斜率信号电平。
表7:通过频率斜率阈值和频率阈值(解释频率斜率由于系统饱和而减小)(利用两
个条件集合)触发听觉指示的代表参数
*这些参数值被设定成适当的极端值,使得其不会有效地参与到逻辑流程中(例如,被设定成始终为“真”)
此种实例运行所产生的数据是通过使用超声器械尽可能快地连续十次切割空肠组织而产生的。图35-36使用来自表7的参数值显示实例性样本情形的频率与时间的关系图。
图35是发生器的一个实施例在对组织(例如空肠组织)进行十次切割的过程中频率与时间的关系波形1802的图示1800以及温度与时间的关系波形1805的图示1804。对于图示1800,频率(Hz)沿垂直轴线显示,并且时间(秒)沿水平轴线显示。对于图示1804,温度(℉)沿垂直轴线显示,并且时间(秒)沿水平轴线显示。
图36是发生器的一个实施例在十次切割组织(例如,空肠组织)的过程中图35所示频率与时间的关系波形1802的图示1805,其中在参考编号1806所标识的部分处激活介于中间的组织。频率(Hz)沿垂直轴线显示,并且时间(秒)沿水平轴线显示。
图35和图36所示的频率波形1802是针对使用两个条件集合以解释由于电系统饱和(减小的位移)而减小的频率斜率的实例情形。应注意,这与如图29-图31A-C所示的测试运行相同在图36中,突出部分1806指示在介入有组织的情况下启动(随着组织变干,频率降低,与组织干燥度相关的局部频率曲线的形状-浅的开始斜率变陡峭),突出部分1808指示在极少或没有组织介入的情况下启动(局部频率斜率非常陡峭,曲线形状更加线性、逐渐变陡峭),曲线的无突出部分1810的区段指示期间装置为进行下一次切割而被重新定位的时间,其中刀片在空中冷却且在放置于组织上时迅速冷却(频率上升)。
图37是发生器的一个实施例在对空肠组织进行十次切割的过程中频率斜率与时间的关系波形1814的图示1812。频率斜率(kHz/s)沿垂直轴线显示,并且时间(秒)沿水平轴线显示。频率斜率波形1814的区域B显示十次切割运行的区域,其中在所述十次切割运行(频率低于55.1kHz且频率斜率小于-0.045kHz/s)期间,条件集合2先于条件集合1被首次触发。期望实现其中条件集合2先于条件集合1被触发的区域B中所示的状况,这是因为超声系统在运行中通过这一点恒定地饱和(电压饱和且电流减小,从而使位移减小,并因此使发热速率减小,从而需要更大的频率斜率阈值)。
图38是功率与时间的关系波形1818的图示1816,所述波形表示发生器的一个实施例在对组织(例如,空肠组织)进行十次切割的过程中所消耗的功率。功率(W)沿垂直轴线显示,并且时间(秒)沿水平轴线显示。
图39是发生器的一个实施例在对空肠组织进行十次切割过程中的电流与时间的关系波形1822的图示1820。电流(mA)沿垂直轴线显示,并且时间(秒)沿水平轴线显示。
已在针对相应的阈值监测频率斜率、谐振频率、或两者方面描述了结合图20-22所示逻辑流程图1200,1300,1400所述组织算法的基本应用,现在将转而描述闩锁逻辑以及其涉及组织算法的相应用法。对组织算法添加闩锁逻辑的动机为:(a)防止条件集合在刀片接触垫的不利条件下由于刀片/垫界面变得更加润滑而复位(条件集合从真变成假);以及(b)防止条件集合由于其中快速发热时段与慢速发热时段交织(热通量进入刀片的区段与热通量离开刀片的区段交织)的脉冲激活而复位(条件集合从真变成假)。图48和图49分别显示这些动机中的第一动机和第二动机。如本公开中在前所定义,实现这些动机的两个闩锁参数是图40所示的“跨回频率斜率阈值”和“最小闩锁时间”。为使本公开完整起见,图43显示针对图41和图42A-C所示的脉冲运行计算得出的频率斜率曲线。
图40是“跨回频率斜率阈值”参数结合频率斜率与时间的关系波形1902的图示1900。如图40所示,“频率斜率阈值”1904由-0.15kHz/s处的水平虚线显示。“跨回频率斜率阈值”1906由-0.02kHz/s处的水平虚线显示。在此情况下,当局部计算的频率斜率跨过“频率斜率阈值”(如指向下方的箭头1908所示)时,条件集合得到满足且响应集合被触发。当局部计算的频率斜率超过“跨回频率斜率阈值”(如指向上方的箭头1910所示)时,条件集合未得到满足(响应集合不再被触发)。应注意,由于在此情形中未使用“跨回超过频率斜率阈值”,因此当局部频率斜率在越过点1911处所示的约4.7秒处跨回超过水平虚线1904时,响应集合不会被触发。
图41是超声器械的一个实施例对离体颈动脉施加脉冲的组合图示1920,其显示所标绘的归一化功率、电流、能量、和频率与时间的关系。
图42A是发生器的一个实施例在一段时间内进行连续组织切割过程中阻抗与时间的关系波形1922以及电流与时间的关系波形1924的图示1921。阻抗(Ω)和电流(mA)沿垂直轴线显示,并且时间(秒)沿水平轴线显示。
图42B是发生器的一个实施例在一段时间内进行连续组织切割过程中的频率与时间的关系波形1925的图示1923。频率(kHz)沿垂直轴线显示,并且时间(秒)沿水平轴线显示。
图42C是发生器的一个实施例在一段时间内进行连续组织切割过程中所标绘的功率波形1926、能量波形1927、第一温度波形1928、以及第二温度波形1929与时间的关系的图示1930。功率(W)、能量(J)、和温度(℃)沿垂直轴线显示,并且时间(秒)沿水平轴线显示。
图42A-C显示超声器械对离体颈动脉的脉冲施加,其中第一脉冲时间是1秒,第一脉冲振幅是功率电平3输出电流的100%。第二脉冲时间是1.5秒,并且第二脉冲振幅比功率电平3输出电流小10%。应注意,谐振频率波形1925显示发热(热通量进入刀片)和冷却(热通量离开刀片)两者的区段。“最小闩锁时间”参数在本文中被定义成对所触发条件集合X进行响应的最小时间量,并且该参数旨在在脉冲施加期间保持响应集合的触发(闩锁时间的一个例子可为约1秒)。还应注意,如图42A所示,在整个运行序列中,负载或阻抗波形1922不会降至低于200Ω。这在考虑到以下情况时可为有利的:用于进行施加的阻抗波形1922持续降至约150Ω以下,同时在两次切割之间在空中的操作暗示可使用阻抗限制来使条件集合复位。在一个方面,可使用此种阻抗限制来实施授予Thomas的美国专利5,026,387中所公开的“空中低驱动”概念。
图43是示出针对图41和图42A-C所示脉冲施加计算得出的频率斜率波形1934的图示1932,该图示按总比例绘制而成。图44是针对图43所示的脉冲施加计算得出的频率斜率波形1934的图示的缩放图。图43和图44两者均显示针对图41和图42A-C所示的脉冲施加计算得出的频率斜率波形1934。频率斜率(kHz/s)沿垂直轴线显示,并且时间(秒)沿水平轴线显示。显示两种比例,其中图43显示频率斜率的总比例,而图44显示“缩放”视图。对于频率斜率,脉冲驱动中显示在连续驱动下可看出的相同趋势,所述脉冲驱动包括与进入刀片的热通量(负的频率斜率)和离开刀片的热通量(正的频率斜率)高度相关的值。频率曲线和频率斜率曲线由于脉冲而具有的瞬变性质连同对频率斜率的移动平均值计算,使得难以在脉冲期间使用频率斜率曲线。应注意,组织在13秒处分离。在图43、尤其是图44中可看出,可在脉冲输出的停留部分中使用冷却速率来触发与快速冷却相关的响应,以使用逻辑(图20-22中的逻辑流程中未示出)完成组织横切,在所述逻辑中,当在停留时段结束时(即,在稳定区域)进行采样时,频率斜率波形1934会超过阈值(在此种情形中约为0.04kHz/s)。在图42A中可看出,可使用阻抗波形1922来触发与高阻抗(对机械运动或振动的高抵抗性)相关的响应,以使用逻辑(同样,图20-22中的逻辑流程中未示出)完成组织横切,在所述逻辑中,当在停留时段开始时(即,在稳定区域)进行采样时,换能器阻抗波形1922会超过阈值(在此种情形中约为700Ω)。
图45是其他所关注数据(例如阻抗、功率、能量、温度)波形1938的图示1936。在图45中,右侧的垂直标度仅适用于阻抗曲线。
本公开现在开始考虑超声器械中的功率电平和夹持压力特征图。刀片与垫界面的发热速率与刀片位移、界面摩擦系数和负载(夹持压力或法向力)成正比。执行测试以在位移(功率电平)以及夹持压力与摩擦系数(主要由垫材料和刀片涂料限定)的装置特定组合的范围内评价算法。
图46是总结各种超声器械类型的加权频率斜率与功率电平的关系的图示1940。加权频率斜率(kHz/s)沿垂直轴线显示,并且功率电平、装置类型、以及装置沿水平轴线显示。用于产生图示1940中所总结数据的器械通常是商购获得的,某些除外。一种测试程序包括:夹持装置、启动装置达三秒、以及计算整个三秒中的平均频率斜率。然而,也可采用其他度量。对于大多数装置而言,图46中所总结的数据将近似表示最小频率斜率值。图46显示对剪刀型超声器械进行老化测试的频率斜率总结数据,在所述老化测试中,器械被夹持,接着被启动达3秒,并且随后被松开—启动的整个三秒中的平均频率斜率被计算并如图所标绘。
基于预定的测试和图46所示的测试数据,建议针对用于某些超声器械的主要功率电平使用以下频率斜率阈值:
(1)电平5频率斜率阈值:-0.060kHz/s;
(2)电平3频率斜率阈值:-0.045kHz/s;
(3)电平5频率斜率阈值:-0.070kHz/s;和
(4)电平3频率斜率阈值:-0.050kHz/s。
系统刚度包括刀片刚度(悬臂梁)和垫刚度/垫热稳定性两者。无负载(无组织)的系统刚度与负载(夹持有组织)的系统刚度的差异越大,组织算法的性能就越稳健。当然,其他限制条件可在极端情况下限制系统刚度。
基于更大的数据集合分析对位移效应的进一步探索。对于超声系统,由于输出电流目标值以及与振动幅值或位移成正比的电流,功率电平必定会有差别。此种数据的分析也可包括对频率数据进行数字平滑以获得可用的频率斜率曲线。
图47-49显示通过使用发生器的一个实施例和超声器械以功率电平5切除猪颈动脉获得的频率和电流与时间的关系波形。
图47是发生器的一个实施例的谐振频率与时间的关系波形1972、平均谐振频率与时间的关系波形1974、以及频率斜率与时间的关系波形1976的图示1970。频率(kHz)和频率斜率(kHz/s)沿垂直轴线显示,并且时间(秒)沿水平轴线显示。频率斜率波形1976是基于平均的频率数据并通过对频率波形1972的数据进行后处理而获得。除经平滑(经由简单的移动平均值)频率数据和频率斜率(由经平滑数据计算得出,这是因为原始频率数据由于流数据的凑整而包含阶梯状)之外,还标绘出原始频率数据。平均谐振频率波形1974是经由谐振频率数据的70毫秒移动平均值(kHz)获得的。
图48是发生器的一个实施例的谐振频率与时间的关系波形1972以及平均谐振频率与时间的关系波形1974的缩放视图1978。频率(kHz)沿垂直轴线显示,并且时间(秒)沿水平轴线显示。
图49是发生器的一个实施例的谐振频率波形1972以及电流与时间的关系波形1982的缩放视图1980。频率(Hz)和电流(A)沿垂直轴线显示。
在图48和图49中分别显示相应的缩放视图1978,1980,以观察平滑频率数据的效应并观察应用起点处的上升信息,这可有助于评价参数(例如等待时间)。
本文所述的组织算法的其他方面可应用于其中(超声刀片与夹持臂之间)保留很少甚至未保留中间组织以及废弃能量倒回端部执行器中的情形。因此,在一个实施例中,可修改组织算法以向与此种情形相关的使用者提供反馈。具体地讲,组织算法支持超声刀片的谐振相对于温度发生改变(随温度上升而减小并随温度降低而增大)的事实。
在一个方面,可采用本文所公开的组织算法来监测波形的频率斜率,其中算法监测谐振频率斜率的变化以指示组织的变化状况。在图50所示的情形中,例如频率响应曲线的拐点与组织开始分离(即,存在组织标记且使用者继续启动器械)的点相关,此可通过实验来证实。可使用频率斜率的变化为使用者提供指示(例如,除在前所述的其他指示之外,还有不同的哔哔声、闪光灯、触觉振动)(以通知使用者废弃能量正在倒回端部执行器中)或可控制或停止发生器输出。
在另一方面,可采用本文所公开的组织算法来监测波形的频率阈值,其中该算法监测当波形越过一些阈值时或与一些已知状态(例如,室温)的差值时的频率变化。与监测频率斜率相似,当频率变化降至一些阈值或差值以下时,可为使用者提供指示,以告知使用者装置端部执行器正在加速地发热。此外,图50提供频率阈值的例证性图示。
在另一方面,可采用本文所公开的组织算法来组合监测频率斜率变化和频率阈值。可使用频率斜率的显著变化与一些阈值以下的频率降低的组合来提供高温指示。
现在参照图50,其为联接到超声器械的发生器的一个实施例的归一化组合功率1991、阻抗1992、电流1993、能量1994、频率1995和温度1996波形的图示1990。如图所示,组织在6.672秒处开始分离。从这一点来讲,在组织完全分离之前,实现总频率降低的约55-60%,温度升高约1.92倍(从219℃到418℃),并且总施加能量的约28%被递送。频率与时间的关系波形的局部斜率由第一组虚线1997显示,该组虚线表示谐振频率斜率的快速变化。监测此斜率1997能够提供指示显著变化的机会,所述显著变化通常发生在具有极少甚至没有中间组织且绝大多数的功率被施加到刀片/组织垫界面的情形中。同样,从已知状态(例如,室温)中的谐振发生的频率变化可用于指示高温—频率变化阈值由第二虚线1998显示。此外,可监测频率斜率变化和频率变化阈值这两者的组合以用于指示。应注意,在此种情形中,频率变化从55,712Hz的初始值变化至55,168Hz的最终值,其中阈值显示于约55,400Hz处。
尽管已举例说明和描述了多个实施例,但是申请人的意图并非将所附权利要求的范围约束或限制在此类细节中。在不脱离本发明的范围的条件下,本领域的技术人员可以作出各种变型、更改和替代。此外,作为另外一种选择,可将与所描述的实施例相关的每个元件的结构描述为用于提供由该元件执行的功能的装置。因此,旨在使所描述的实施例仅受所附权利要求的范围的限制。
在整篇说明书中引用的“各种实施例”、“一些实施例”、“一个实施例”或“实施例”是指结合所述实施例描述的特定特征、结构或特性包括在至少一个实施例中。因此,在整篇说明书中出现的短语“在各种实施例中”、“在一些实施例中”、“在一个实施例中”或“在实施例中”并不一定都指相同的实施例。此外,在一个或多个实施例中,具体特征、结构或特性可按任何合适的方式组合。因此,在没有限制的情况下,结合一个实施例示出或描述的具体特征、结构或特性可全部或部分地与一个或多个其他实施例的特征、结构或特性组合。
Claims (9)
1.一种驱动联接到外科器械的超声驱动系统的端部执行器的方法,所述方法包括:
通过发生器生成至少一个电信号;
针对第一组逻辑条件监测所述至少一个电信号;以及
当满足所述第一组逻辑条件时,
触发所述发生器的第一响应;
其中所述第一响应包括脉冲响应;
通过所述发生器在第一脉冲时间生成第一脉冲振幅,其中所述第一脉冲时间是所述第一脉冲振幅被所述发生器驱动的周期;以及
通过所述发生器在第二脉冲时间生成第二脉冲振幅,其中所述第二脉冲时间是所述第二脉冲振幅被所述发生器驱动的周期。
2.根据权利要求1所述的方法,包括当满足所述第一组逻辑条件时触发听觉响应。
3.根据权利要求1所述的方法,包括当满足所述第一组逻辑条件时触发视觉响应。
4.根据权利要求1所述的方法,包括通过所述发生器重复生成所述第一脉冲振幅和所述第二脉冲振幅。
5.根据权利要求1所述的方法,包括:
针对第二组逻辑条件监测所述至少一个电信号;以及
当满足所述第二组逻辑条件时,
触发所述发生器的第二响应。
6.根据权利要求5所述的方法,包括在分层的基础上确定所述第一响应或所述第二响应的触发。
7.一种用于驱动联接到外科器械的超声驱动系统的端部执行器的装置,发生器包括:
信号处理器,所述信号处理器能够操作以生成至少一个电信号;
第一电路,所述第一电路用以针对第一组逻辑条件监测所述至少一个电信号;和
第二电路,所述第二电路用以当满足所述第一组逻辑条件时触发所述发生器的第一响应;
脉冲电路,所述脉冲电路联接到触发电路并且响应所述触发电路;
其中所述脉冲电路能够操作以在第一脉冲时间生成第一脉冲振幅,其中所述第一脉冲时间是所述第一脉冲振幅被所述发生器驱动的周期;以及在第二脉冲时间生成第二脉冲振幅,其中所述第二脉冲时间是所述第二脉冲振幅被所述发生器驱动的周期。
8.根据权利要求7所述的装置,包括联接到触发电路并且响应所述触发电路的扬声器。
9.根据权利要求7所述的装置,包括联接到触发电路并且响应所述触发电路的显示器。
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