CN102119005B - 利用阶跃性输出进行切割和凝结的超声装置 - Google Patents

利用阶跃性输出进行切割和凝结的超声装置 Download PDF

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CN102119005B
CN102119005B CN200980131055.3A CN200980131055A CN102119005B CN 102119005 B CN102119005 B CN 102119005B CN 200980131055 A CN200980131055 A CN 200980131055A CN 102119005 B CN102119005 B CN 102119005B
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ultrasonic
frequency
generator
drive signals
tissue
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CN102119005A (zh
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J·R·吉奥尔达诺
R·J·比特尔
E·T·韦纳
J·D·梅瑟利
P·玛拉维亚
B·迪纳多
D·J·阿伯特
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Ethicon Endo Surgery Inc
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    • A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A61B17/320092—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw
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    • B06B1/00—Methods or apparatus for generating mechanical vibrations of infrasonic, sonic, or ultrasonic frequency
    • B06B1/02—Methods or apparatus for generating mechanical vibrations of infrasonic, sonic, or ultrasonic frequency making use of electrical energy
    • B06B1/0207—Driving circuits
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Abstract

本发明公开的各实施例均涉及用于驱动连接至外科器械中的超声换能器的端部执行器的设备、系统和方法。所述方法包括：通过连接至所述超声驱动系统的发生器产生第一超声驱动信号；在第一周期，利用所述第一超声驱动信号致动所述超声换能器；通过发生器产生第二超声驱动信号；以及在所述第一周期之后的第二周期，利用所述第二超声驱动信号致动所述超声换能器。在对应的第一和第二周期上，所述第一驱动信号不同于所述第二驱动信号。在所述第一和第二周期上，所述第一和第二驱动信号定义阶跃函数波形。所述设备包括被构造为连接至超声器械的发生器。所述系统包括连接至超声器械的发生器。所述超声器械包括超声驱动系统，所述超声驱动系统包括连接至波导的超声换能器和连接至所述波导的端部执行器，其中所述超声驱动系统被构造为以谐振频率谐振。

Description

利用阶跃性输出进行切割和凝结的超声装置
相关专利申请交叉引用
本申请要求根据Title 35，United States Code§119(e)(美国法典第35篇第119条(e))的(1)于2008年8月6日提交的名称为“Ultrasonic Device for Cutting and Coagulating with Stepped Output”(利用阶跃性输出进行切割和凝结的超声装置)的美国临时专利申请No.61/086619以及(2)于2008年8月13日提交的名称为“UltrasonicDevice for Cutting and Coagulating with Stepped Output”(利用阶跃性输出进行切割和凝结的超声装置)的美国临时专利申请No.61/188790的优先权，上述申请二者据此全文引入以供参考。
技术领域
本发明整体涉及一种超声外科手术系统，更具体地讲，涉及一种允许外科医生执行切割和凝结的超声系统。
背景技术
超声外科器械凭这种器械的独特的性能特性而在外科手术中日益得到广泛的应用。根据具体器械构型和操作参数，超声外科器械可通过凝结提供基本上同时的组织切割和止血，从而有利地将患者创伤最小化。切割动作通常通过在器械远端端部处的端部执行器或刀头来完成，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以被构造用于开放性外科手术用途、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同时用于精确切割和受控凝结。与电外科使用的温度相比，超声能量切割和凝结使用更低的温度。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结物。刀片表面施加于组织上的压力使血管伸缩并允许所述凝结物形成止血密封。切割和凝结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显示了：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远离时，产生最佳血管密封。目前致力于实现这种分离包括增大施用于血管的夹持力。
此外，使用者并不总是能够获得被切割的组织的视觉反馈。因此，当不可获得视觉反馈时，希望提供一些形式的反馈来提醒使用者切割已完成。此外，如果没有用于提醒切割已完成的一些形式的反馈指示，使用者可能在切割已完成的情况下继续激活谐波器械，这样，当在夹具之间没有物质的情况下激活谐波器械时产生的成指数增长的热会对谐波器械以及周围的组织造成可能的损坏。
希望提供克服当前器械的某些缺陷的超声外科器械。本文所述的超声外科器械克服了这些缺陷。
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构造为允许在外科手术过程中选择性地解剖、切割、凝结和夹持组织。在一个实施例中，端部执行器连接至外科器械的超声驱动系统。连接至超声驱动系统的发生器产生第一超声驱动信号。所述超声驱动系统包括连接至波导的超声换能器和连接至波导的端部执行器。所述超声驱动系统被构造为以谐振频率谐振。在第一周期利用第一超声驱动信号致动所述超声换能器。所述发生器产生第二超声驱动信号。在第一周期之后的第二周期利用第二超声驱动信号致动所述超声换能器。在对应的第一和第二周期上，所述第一驱动信号不同于所述第二驱动信号。在所述第一和第二周期上，所述第一和第二驱动信号限定阶跃函数波形。
附图说明
所描述的实施例的新颖特征在所附权利要求书中进行了详细描述。然而，对组织和操作方法来说皆可以通过结合附图参照以下具体实施方式最深刻地理解所描述的实施例，其中：
图1是显示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透视装配图。
图3是夹持臂的一个实施例的示意图，其显示了力的计算。
图4是传统振荡器在高功率和轻负载时的电流、电压、功率、阻抗和频率波形的图示。
图5是传统振荡器在高功率和重负载时的电流、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，其创建了用于驱动超声换能器的超声电信号。
图10示出了外科手术系统的一个实施例，其包括超声外科器械和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示出了可与外科手术系统一起使用的夹持臂组件的一个实施例。
图13是连接至刀片和夹持臂组件的组织阻抗模块的示意图，其中组织位于所述刀片和夹持臂组件之间。
图14示出了用于驱动连接至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因此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。
具体实施方式
在详细说明超声外科器械的多个实施例之前，应该指出的是，示例性实施例的应用或使用并不局限于附图和具体实施方式中详细示出的部件的构型和布置。示例性实施例可以单独实施，或与其他实施例、变更形式和修改形式结合实施，并可以多种方式实施或执行。此外，除非另外指明，否则本文所用的术语和公式是为了方便读者而对示例性实施例进行描述目的所选的，并非为了限制性的目的。
此外，应当理解，下述实施例、实施例表达、实例中的任何一个或多个可与下述其他实施例、实施例表达和实例中的任何一个或多个结合。
各实施例均涉及改进的超声外科器械，其被构造为在外科手术中使组织解剖、切割和/或凝结更有效。在一个实施例中，超声外科器械设备被构造为用于开放性外科手术中，但是所述设备可应用于其它类型的手术(例如腹腔镜、内窥镜和机器人辅助手术)中。通过选择性地使用超声能量，方便了多种用途。
将结合本文描述的超声器械描述各实施例。通过举例而非限制的方式提供该具体实施方式，并且不意图限制其范围和应用。例如，任一个所描述的实施例在与多个超声器械结合时是可用的，所述超声器械包括在例如美国专利No.5,938,633、No.5,935,144、No.5,944,737、No.5,322,055、No.5,630,420和No.5,449,370中描述的那些。
从以下描述中将变得明显的是，设想本文描述的外科器械的实施例可与外科系统的振荡器单元相连使用，从而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，本文描述的外科器械的实施例可与外科系统的信号发生单元相连使用，从而例如射频(RF)形式的电能可用于为与外科器械有关的使用者提供反馈。超声振荡器和/或信号发生单元可与所述外科器械不可拆卸地一体化，或者可作为分离的组件被提供，其可电附接至所述外科器械。
当前外科器械的一个实施例被特别构造为根据其简单构造而用于一次性使用。然而，还设想当前外科器械的其它实施例可被构造为用于非一次性或多次使用。只是为了进行示意性的说明，现在针对单个患者的使用公开当前外科器械与相关振荡器和信号发生单元的可拆卸连接。然而，还设想了当前外科器械与相关振荡器和/或信号发生单元的不可拆卸的一体式连接。因此，当前描述的外科器械的各种实施例可被构造为用于单次使用和/或多次使用，并且所述外科器械与可拆卸的和/或不可拆卸的一体的化振荡器和/或信号发生单元一起使用，在没有限制的情况下，这些构造的所有组合均被设想为落入本发明的范围内。
参照图1-3，示出了包括超声外科器械100的外科手术系统19的一个实施例。外科手术系统19包括超声发生器30和超声外科器械100，超声发生器30通过例如线缆22的合适的传输介质连接至超声换能器50。在当前公开的实施例中，虽然发生器30被显示为与外科器械100分离，但是在一个实施例中，发生器30可与外科器械100一体地形成，以形成一体式外科手术系统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可包括产生适于编程发生器30的操作的信号的任何合适的装置，如随后将参照图9的描述。仍参照图1-3，线缆22可包括多个电导体，所述电导体用于将电能应用至超声换能器50的正(+)电极和负(-)电极。应当注意的是，在一些应用中，超声换能器50可被称作“柄部组件”，这是因为在各种手术和操作中，外科手术系统19的外科器械100可被构造为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Cincinnati，Ohio的Ethicon Endo-Surgery，Inc.售卖的GEN 300，其在以下全部以引用方式并入本文的一个或多个美国专利中公开，所述美国专利有：美国专利No.6,480,796(Method for Improving the Start Up ofan Ultrasonic System Under Zero Load Conditions(在零负载条件下改进超声系统的启动的方法))；美国专利No.6,537,291(Method forDetecting a Loose Blade in a Handle Connected to an Ultrasonic SurgicalSystem(在连接至超声外科系统的柄部中检测松懈的刀片的方法))；美国专利No.6,626,926(Method for Driving an Ultrasonic System toImprove Acquisition of Blade Resonance Frequency at Startup(驱动超声系统以在启动时改进对刀片谐振频率的获取的方法))；美国专利No.6,633,234(Method for Detecting Blade Breakage Using Rate and/orImpedance Information(利用速率和/或阻抗信息检测刀片破损的方法))；美国专利No.6,662,127(Method for Detecting Presence of a Bladein an Ultrasonic System(在超声系统中检测刀片的存在的方法))；美国专利No.6,678,621(Output Displacement Control Using Phase Margin inan Ultrasonic Surgical Handle(在超声外科柄部中利用相补角的输出位移控制))；美国专利No.6,679,899(Method for Detecting TransverseVibrations in an Ultrasonic Handle(在超声柄部中检测横向振动的方法))；美国专利No.6,908,472(Apparatus and Method for AlteringGenerator Functions in an Ultrasonic Surgical System(在超声外科系统中改变发生器功能的设备和方法))；美国专利No.6,977,495(DetectionCircuitry for Surgical Handpiece System(用于外科手持件系统的检测电路))；美国专利No.7,077,853(Method for Calculating TransducerCapacitance to Determine Transducer Temperature(计算换能器电容以确定换能器温度的方法))；美国专利No.7,179,271(Method for Drivingan Ultrasonic System to Improve Acquisition of Blade Resonance Frequencyat Startup(驱动超声系统以在启动时改进对刀片谐振频率的获取的方法))；以及美国专利No.7,273,483(Apparatus and Method for AlertingGenerator Function in an Ultrasonic Surgical System(在超声外科手术系统中警示发生器功能的设备和方法))。
根据所描述的实施例，超声发生器30产生特定电压、电流和频率(例如，每秒55,500次循环(Hz))的电信号。发生器30通过线缆22连接至柄部组件68，柄部组件包含形成超声换能器50的压电陶瓷元件。响应于柄部组件68上的开关312a或通过另一线缆连接至发生器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。用一个结构体将换能器50连接至外科手术刀片79，因此当发生器信号被施加至换能器50时刀片以超声频率振动。所述结构体被设计为在选定的频率谐振，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被构造为产生特定电压、电流和/或频率的输出信号，所述信号可在高分辨率、精确性和再现性的情况下阶跃。
参照图4，在当前系统中，在时刻0触发常规振荡器，导致电流300升至大约340mA的期望设定点。在大约2秒时，施加轻负载，导致电压310、功率320、阻抗330的相应增大和谐振频率340的变化。
参照图5，在当前系统中，在时刻0触发常规振荡器，导致电流300升至大约340mA的期望设定点。在大约2秒时，施加增大的负载，导致电压310、功率320、阻抗330的相应增大和谐振频率340的变化。在大约7秒时，负载增大到使振荡器进入到平坦功率模式的点，在平坦功率模式，只要振荡器保持在电源的电压范围内，负载的进一步增大使功率保持在35W。因此，电流300和位移在平坦功率模式中改变。在大约11.5秒，负载降低至电流300返回到大约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。
现在回头参照图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中包含的声学组件的振动隔离。可将柄部组件68成形为用户能够以常规方式抓握的形状，但可以设想主要通过器械的柄部组件提供的扳机状装置来抓紧和操纵现有的超声外科器械100，如下文所述。尽管示出多件式柄部组件68，但柄部组件68可以包括单个元件或一体式组件。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中来接纳该换能器50的远端并装配到其上。在一个实施例中，超声外科器械100可以作为一个单元附接到超声换能器50并且可从其移除。在其它实施例中，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68包括配合壳体部分69、壳体部分70和传输组件71。当当前器械被构造为用于内窥镜式使用时，所述构造的尺寸可被规定为使得传输组件71的外径为大约5.5mm。超声外科器械100的细长传输组件71从器械柄部组件68正交地延伸出。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，如以下进一步描述的那样。柄部组件68可以由耐用塑料构造，例如聚碳酸酯或液晶聚合物。也可设想柄部组件68可以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，端部执行器81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可以为柔性、半柔性或刚性的。如本领域中所熟知，波导80也可以被构造为将通过波导80传输到刀片79的机械振动放大。波导80还可以具有控制沿着波导80的纵向振动增益的部件和将波导80调谐到系统谐振频率的部件。特别是，波导80可以具有任何合适的横截面尺寸。例如，波导80可以具有基本上均一的横截面或波导80可以在多个截面处渐缩或可沿着其整个长度渐缩。在当前实施例的一个表现形式中，波导的直径为约标称0.113英寸，以最小化刀片79的偏转量，从而最小化端部执行器81的近端部分的间隙。
刀片79可以与波导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可以通过螺纹连接、焊接接头或其他连接机构连接。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其调谐至优选的谐振频率fo。超声换能器50通电时，刀片79的远端被构造为在(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纵向移动。
具体参照图1-3，显示了用于当前超声外科器械100的夹持构件60的一个实施例，并且所述夹持构件60被构造为与刀片79协同操作。与刀片79结合的夹持构件60通常被称为端部执行器81，且夹持构件60还通常被称作夹具。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的远端端部以及致动构件76，所述夹持臂56与组织接合垫或夹持垫58结合。夹持臂56通过触发器34可枢转运动，且端部执行器81通过旋转旋钮29可旋转运动。在实施例的一个表现形式中，夹持垫58由TEFLON
Figure BPA00001309737100091
(E.I.Du Pont de Nemours and Company的商标名)、低摩擦系数聚合材料或任何其它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配合，夹持臂56的枢转运动将夹持垫58定位为与刀片79基本平行并接触，从而限定组织治疗区。通过这种构造，组织被抓紧于夹持垫58和刀片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，以提高与刀片79协作对组织的紧握。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实例，用以防止组织相对于刀片79的运动而移动。其它示例性实例包括凸耳、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的最远端部分，而组织治疗区的近端部分位于远端刀头振幅的大约50％的位置处。在操作期间，端部执行器81的近端区域中的组织将脱水和变薄，且端部执行器81的远端部分将横切远端区域中的组织，从而允许近端区域中的脱水和变薄的组织朝远端滑动至端部执行器81的更加活性的区域，以完成组织横切。
图3显示了力的图示以及致动力FA(通过致动构件76提供)和横切力FT(在最佳组织治疗区的中点测量到)之间的关系。
FT＝FA(X2/X1)             (1)
其中FA等于近端弹簧94(更少的摩擦损失)的弹簧预负载，在一个实施例中，为约12.5磅，且FT等于约4.5磅。
在夹持臂/刀片交界处的区域中测量FT，在所述交界处发生最佳组织治疗，如组织标记61a和61b所限定的。组织标记61a、b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、b在距离上相隔约7mm，且更优选地在距离上相隔约5mm。
图9显示了发生器30的驱动系统32的一个实施例，其产生用以驱动超声换能器的超声电子信号。驱动系统32是柔性的并且可创建期望频率和功率电平设定的超声电子驱动信号416，以驱动超声换能器50。在各实施例中，发生器30可包括若干分离的功能性元件，例如模块和/或块。虽然某些模块和/或块可通过实例描述，但是可理解，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，虽然各实施例可按照模块和/或块的形式描述以便于说明，但这些模块和/或块可通过一个或多个硬件组件和/或软件组件和/或硬件和软件组件的组合组件实施，所述硬件组件例如是处理器、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，所述软件组件例如是程序、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可包括其它类型的存储器，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驱动系统32包括用处理器400实现的硬件组件，用以在切割和/或凝结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产生用以驱动超声换能器50的阶跃函数输出信号。本领域技术人员应当理解，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。在各实施例中，如前面讨论的，硬件组件可实现为DSP、PLD、ASIC、电路和/或寄存器。在一个实施例中，处理器400可被构造为存储和执行计算机软件程序指令，以产生用以驱动超声外科器械100的各组件(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执行根据所描述的实施例的方法来产生阶跃函数，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而产生，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)可以是预定的(例如，固定的和/或通过用户编程的)或者可以是可变的。可变时间间隔可通过将驱动信号设定为第一值和在监控的特性中检测到变化之前将驱动信号保持在该值来限定。监控的特性的实例可包括(例如)换能器阻抗、组织阻抗、组织发热、组织横切、组织凝结等。非限制性地，发生器30产生的超声驱动信号包括能够按照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和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个或多个阶跃函数算法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而产生，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。根据所述一个或多个阶跃输出算法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产生驱动信号。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监控的特性(例如，换能器阻抗、组织阻抗)改变。在编程的递增或递减中，所述阶跃可变化。如果需要其它阶跃，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，用户可利用位于发生器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可包括产生信号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至通用或专用计算机。在其它实施例中，输入装置406可包括合适的用户界面。因此，通过输入装置406，用户可设定或编程电流(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来显示选定的功率电平。
在各实施例中，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)或随后描述的其它测量来确定组织切割和凝结何时完成。通过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，其包括白炽光灯或发光二极管(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。通过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可被构造或编程为产生数字电流信号414和数字频率信号418。这些信号414、418被施用到直接数字合成器(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的输出被施用至放大器422，放大器422的输出被施用至变压器424。变压器424的输出是施用至超声换能器50的信号416，换能器50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，其可被构造为监控超声器械100(图1)的可测量特性。在图示实施例中，可采用处理器400来监控和计算系统特性。如图所示，处理器400通过监控供应到换能器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被施用至模数转换器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ADC 432，以备转换。在其它实施例中，可采用多个ADC 432来替代多路复用器430电路用于每个测量的特性。处理器400接收ADC 432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，使得驱动信号416可产生期望的功率对负载曲线。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按照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在无负载状态下的一个实施例的电流300、电压310、功率320、阻抗330和频率340波形的图示。在图示实施例中，发生器30的电流300输出是阶跃的。如图6所示，发生器30在约时刻0处被激活，导致电流300升高到大约100mA的第一设定点I1。电流300在第一设定点I1保持第一周期T1。在第一周期T1的最后(例如在图示实施例中约1秒钟处)，电流300的设定点I1通过发生器30根据软件(例如，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(例如在图示实施例中约2秒钟)。在第二周期T2的最后(例如在图示实施例中约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。因为系统上无负载，所以电压310、电流300、功率320和频率响应仅是轻微的。
图7是发生器30在轻负载状态下的一个实施例的电流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在约时刻0处被激活，导致电流300升高到大约100mA的第一电流300设定点I1。在约1秒时，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秒时，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在重负载状态下的一个实施例的电流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在约时刻0处被激活，导致电流300升高到大约100mA的第一设定点I1。在约1秒时，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秒时，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中描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)不限于本文描述的值并可被调节为可被外科手术的给定设置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内的周期。如先前的讨论，周期可通过编程预定或可根据可测量的系统特性改变。该实施例不局限于这种情况。
根据所描述的外科手术系统19的各实施例的操作性细节，可根据采用一种外科器械针对切割和凝结血管的处理进一步描述上述外科手术系统19的操作，所述外科器械包括输入装置406和参照图9描述的换能器阻抗测量能力。虽然结合操作细节描述了具体处理，但是可以意识到所述处理只是提供了本文描述的一般功能性怎样通过外科手术系统19实施的一个实例。此外，除非另外指定，否则给定处理不是必须按照本文展示的次序执行。如前所述，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。虽然传统方法已通过增加施加到夹持构件60的力实现了这种分离，但是本文公开的是不仅仅依赖夹持力来切割和凝结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于超声换能器50，从而根据阶跃函数在多种模式下机械地移动刀片79。在一个实施例中，频率阶跃函数可通过用户界面406编程，其中用户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)。用户可通过针对多个周期设置多个频率来编程完整的操作循环，从而执行各种外科手术。
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，第一超声频率可一开始被设定为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或其它结构性谐振频率，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据的时间长度，或者可基于测量到的系统特性(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/血管横切处理(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的特性来自动化，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，以提供用于处理器400的触发器，从而产生频率和/或电流阶跃函数输出。如先前参照图9的描述，在刀片79处于各种负载下的同时，换能器50的阻抗Z可基于流动通过换能器50的电流和施加于换能器50的电压而通过处理器400计算。因为换能器50的阻抗Z与施加于刀片79的负载成比例，所以随着刀片79的负载增加，换能器50的阻抗Z也增加，并且随着刀片79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可被监控，以检测从外膜层脱离的血管的内部肌肉组织层的横切，并且还可被监控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，频率阶跃函数输出的初始化可基于换能器阻抗Z和与相对于刀片79的组织负载相关的一个或多个预定阈值的比较。当换能器阻抗Z转变为高于或低于(例如，越过)阈值时，处理器400将数字频率信号418施加至DDS电路420，从而响应于换能器阻抗Z根据阶跃函数算法402通过预定阶跃改变驱动信号416的频率。在操作中，刀片79被首先布置在组织治疗部位。处理器400施加第一数字频率信号418以设定偏谐振(例如，fo/2、2fo或其它结构性谐振频率，其中fo为谐振频率)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的激活而施加至换能器50。在这个周期中，超声换能器50在第一驱动频率f1下机械地激活刀片79。力或负载可施加至夹持构件60和刀片79，以有利于该处理。在这个周期中，在刀片79上的负载发生变化并且换能器阻抗Z越过指示组织层被横切的预定阈值之前，处理器400监控换能器阻抗Z。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、凝结和密封组织的其它合适的频率。组织的另一部分(例如，血管)随后被抓紧于夹持构件60和刀片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。本领域技术人员应当理解，驱动电流(I)输出也可如参照图6-8的描述基于换能器阻抗Z阶跃。
根据一个阶跃函数算法402，处理器400一开始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。在操作的这个周期，处理器400监控换能器阻抗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，切割更多的组织使刀片79上的负载降低，因此换能器阻抗Z降低。当换能器阻抗Z降至低于预定阈值时，检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。然后在刀片79和夹持构件60之间抓紧血管，并且通过致动脚踏开关或柄部组件68上的开关来激活换能器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的变化可在约1.5至约4倍于基本阻抗测量值之间。
图10显示了外科手术系统190的一个实施例，其包括超声外科器械120和包括组织阻抗模块502的发生器500。在当前公开的实施例中，虽然发生器500被显示为与外科器械120分离，但是在一个实施例中，发生器500可与外科器械120一体化形成以形成一体式外科手术系统190。在一个实施例中，发生器500可被构造为监控组织的电阻抗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中显示的一个实施例中，外科手术系统190的端部执行器810部分包括连接至外部护套72的远端端部的夹持臂组件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)电极的导电性部分。组织阻抗模块502通过合适的传输介质(例如，线缆504)连接至刀片79和夹持臂组件451。线缆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动通过组织的电流返回到阻抗模块502的返回路径。在各实施例中，组织阻抗模块502可与发生器500一体地形成或者可作为连接至发生器500的分离的电路被提供(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显示了发生器500的驱动系统321的一个实施例，所述发生器500包括组织阻抗模块502。驱动系统321产生超声电子驱动信号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可被构造为测量抓紧于刀片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RF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RF电压vrf和流动通过刀片79电极、组织和夹持臂组件451的导电部分的RF电流irf。感测到的电压vrf和电流irf经模拟多路复用器430通过ADC 432转变为数字形式。处理器400接收ADC 432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RF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的检测可与自动处理一体化，所述自动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显示了夹持臂组件451的一个实施例，所述夹持臂组件451可与外科手术系统190一起使用(图10)。在图示实施例中，夹持臂组件451包括安装到基部449的导电性外套472。所述导电性外套472是形成第二(例如，返回)电极的夹持臂组件451的导电性部分。在一个具体实施中，夹持臂56(图3)可形成基部449，其中导电性外套472安装于所述基部449上。在各实施例中，导电性外套472可包括中心部分473和至少一个向下延伸的侧壁474，所述侧壁474可延伸至基部449的底表面475之下。在图示实施例中，所述导电性外套472具有在基部449的相对两侧向下延伸的两个侧壁474。在其它实施例中，中心部分473可包括至少一个孔476，所述孔476可被构造为接纳从基部449延伸的突起477。在这些实施例中，突起477可被压力配合到孔476中，以将导电性外套472固定到基部449上。在其它实施例中，突起477可在插入孔476中之后变形。在各实施例中，可使用紧固件来将导电性外套472固定到基部449。
在各实施例中，夹持臂组件451可包括(例如)布置于导电性外套472和基部449之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性外套472和基部449之间流动或短路。在各实施例中，基部449可包括至少一个孔478，其可被构造为接纳枢轴销(未示出)。例如，枢轴销可被构造为将基部449可枢转地安装到护套72(图10)上，从而使夹持臂组件451可相对于护套72在打开和关闭位置之间旋转。在图示实施例中，基部449包括布置在基部449的相对的侧部上的两个孔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)形成或可包括非导电性材料或绝缘材料，所述材料可被构造为即使(例如)在基部449与导电性外套472电接触的情况下也防止电流流入外部护套72中。额外的夹持臂组件包括可被使用的电极的各实施例。这种夹持臂组件的实例在共同所有并同期提交的美国专利申请No.12,503,769、No.12/503,770和No.12,503,766(代理人案卷号为END6493USNP/080592、END6493USNP1/080593和END6493USNP2/080594)中有所描述，上述各个申请都以引用方式并入本文。
图13是连接至刀片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79和所述夹持臂组件415之间。现在参照图10-13，发生器500包括被构造为在组织横切处理过程中用于监控位于刀片79和夹持臂组件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通过线缆504连接至超声外科器械120。线缆504包括连接至刀片79(例如，正[+]电极)的第一“激励”导体504a和连接至夹持臂组件451的导电性外套472(例如，负[-]电极)的第二“返回”导体504b。在一个实施例中，RF电压vrf被施加至刀片79，以使得RF电流irf流动通过组织514。第二导体504b提供用于使电流irf返回到组织阻抗模块502的返回路径。返回导体504b的远端端部连接至导电性外套472，使得电流irf可从刀片79流动通过位于导电性外套472和刀片79之间的组织514以及通过导电性外套472抵达返回导体504b。阻抗模块502通过第一和第二导体504a、b连接至电路中。在一个实施例中，RF能量可通过超声换能器50和波导80施加至刀片79(图2)。值得注意的是，用于测量组织阻抗Zt的施加至组织514的RF能量是对于组织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。
根据对外科手术系统190的各实施例的操作性细节的描述，可根据采用包括输入装置406和组织阻抗模块502的外科器械切割和凝结血管的处理并参照图10-13进一步描述上述外科手术系统190的操作。虽然已经结合操作性细节描述了特定处理，但是应当理解，所述处理仅提供了本文描述的一般功能性怎样通过外科手术系统190实施的一个实例。此外，除非另外指明，否则给定的处理不一定按照本文展现的次序执行。如先前所讨论的，可采用输入装置406来为超声换能器50/刀片79组件编程阶跃函数输出(例如，电流、电压、频率)。
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初始化频率阶跃函数输出。当组织阻抗Zt转变为高于或低于(例如，横越)阈值时，处理器400将数字频率信号418施加至DDS电路420，从而响应于换能器阻抗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。组织514被抓紧于刀片79和夹持臂组件451之间，使得刀片79和导电性外套472与组织514电接触。处理器400施加第一数字频率信号418以设定偏谐振(例如，fo/2、2fo或其它结构性谐振频率，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RF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，所以组织514开始脱水，使得组织阻抗Zt减小。最终，随着组织被所述超声行为和施加的夹持力横切，组织阻抗Zt变得非常高或无限大。本领域技术人员应当理解，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监控。可测量的RF电流i1经过第一激励导体504a传递至刀片79，经过组织514，然后经过导电性外套472和第二导体504b返回到阻抗模块502。随着组织514脱水和被相对于一个或多个夹持垫58作用的刀片79的超声行为切割，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ADC 432，所述ADC 432的信号输出433提供至处理器400。处理器400基于vrf和irf的这些测量的值计算组织阻抗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来使频率阶跃。处理器400控制驱动信号416，并可响应于组织阻抗Zt对振幅和频率做出任何必要的调整。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。如先前所讨论的，根据一个阶跃函数算法，处理器400一开始设定显著偏谐振的第一驱动频率f1。换能器50被激励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RF电压vrf信号施加至刀片79。在该操作周期T1内，处理器400监控组织阻抗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和夹持臂组件451之间，并且换能器50被再激活以横切和密封血管。对组织阻抗Zt的持续监控提供血管何时被横切和密封的指示。另外，可监控组织阻抗Zt以提供组织切割和/或凝结处理完成的指示，或者当组织阻抗Zt达到预定阈值时停止超声发生器500的激活。组织阻抗Zt的阈值可被选定为(例如)指示血管已被横切。在一个实施例中，从起始点至肌肉层正好被横切和密封的点，组织阻抗Zt的范围可以在约10Ohms至约1000Ohms之间。
申请人已发现操纵变化的电流设定点(增大和减小二者)和保压时间的实验指示：在完成横切之前，所描述的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横切部位的总能量(热)。此外，虽然已经参照阻抗阈值检测方案描述了外科器械100、120以确定肌肉层何时从外膜层分离，但是不采用任何检测方案的其它实施例也在本发明的范围内。例如，外科器械100、120的实施例可在简化的外科手术系统中采用，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大约1秒或更少的预定时间。该实施例不局限于这种情况。
已描述了外科手术系统19(图1)和190(图10)的各实施例的操作性细节，根据采用包括输入装置406和组织阻抗模块502的外科器械的用于切割和凝结组织的方法可进一步总体描述以上外科手术系统19、190。虽然结合操作性细节描述了特定方法，但是应当理解，所述方法只提供了怎样将本文描述的一般功能性通过外科手术系统19、190进行实施的一个实例。此外，除非另外指明，否则给定的工艺不是必须按照本文展现的次序执行。如先前的讨论，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示出了驱动连接至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)连接至超声驱动系统。超声驱动系统包括连接至波导(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连接至波导80。超声驱动系统被构造为在谐振频率(例如，55.5kHz)下谐振。在一个实施例中，在602，发生器30产生第一超声驱动信号。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)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产生第二超声驱动信号。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在第二周期通过第二超声驱动信号被致动。在对应的第一和第二周期，第一驱动信号不同于第二驱动信号。第一和第二驱动信号限定第一和第二周期上的阶跃函数波形。
在一个实施例中，发生器30产生第三超声驱动信号。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、第二和第三周期，第三驱动信号不同于第一和第二驱动信号。第一、第二和第三驱动信号限定第一、第二和第三周期上的阶跃函数波形。在一个实施例中，产生第一、第二和第三超声驱动信号的步骤包括：产生对应的第一、第二和第三驱动电流；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，和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产生不同于谐振频率的第一频率的第一超声驱动信号。然后在第一周期利用第一频率的第一超声驱动信号致动超声换能器50。在第一频率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，将血管的内部肌肉层与外膜层分离。发生器30产生谐振频率(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的第二超声驱动信号致动超声换能器50。在第二、谐振频率的致动为端部执行器81提供第二水平的机械振动，其适于对第一组织，例如血管进行横切和密封(一旦其与内部肌肉层分离)。在一个实施例中，在第一周期之后，谐振频率的第二超声驱动信号通过发生器30自动地产生。在一个实施例中，第一频率基本不同于谐振频率，并且第一周期小于约一秒。例如，在一个实施例中，第一频率通过以下公式限定：f1＝2*fo，其中f1是第一频率，且fo是谐振频率。在另一个实施例中，第一频率通过以下公式限定：f1＝fo/2，其中f1是第一频率，且fo是谐振频率。还预想第一、第二和第三超声驱动信号用于执行超声换能器50处于纵向、弯曲和扭转模式以及其谐波的振动模式。
在一个实施例中，发生器30监控超声驱动系统的可测量特性并基于测量到的特性产生第一和第二驱动信号中的任一个。例如，发生器30监控超声换能器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)感测流动通过换能器50的电流，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，ADC 432)，ADC 432的数字输出提供至处理器(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RF振荡器(例如，RF振荡器506)以产生亚治疗RF信号。亚治疗RF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。所述组织部分被抓紧于端部执行器810和夹持臂组件(例如，夹持臂组件451)以及组织(例如，组织514)的阻抗的回复电极之间。然后通过阻抗模块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施加至ADC 432。ADC 432的数字输出提供至处理器400，其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计算组织阻抗Zt。
图15A-C示出了操作的逻辑流程图700、800、900的各实施例，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，当组织从其它组织或骨骼层上分离时，当组织被切割或横切时，当组织被凝结时等等，组织可经历的状态的变化，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。
在各实施例中，通过图9和图11显示的输出指示器412提供反馈。输出指示器412在以下应用中特别有用，所述应用即，被端部执行器81、810操纵的组织脱离使用者的视野并且使用者不能看见组织中发生的状态变化时。根据参照逻辑流程图700、800、900描述的操作确定，输出指示器412与用户通信，以通知组织状态发生变化。如先前的讨论，输出指示器412可被构造为给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)组织已经历组织的状态变化。通过举例而非限制的方式，如先前的讨论，视觉反馈包括任何类型的视觉指示装置，包括白炽光灯或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。通过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描述的逻辑流程图700、800、900描述的操作基于电压、电流和频率测量确定。
在一个实施例中，逻辑流程图700、800、900可作为可执行模块(例如，算法)实施，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。在各实施例中，参照逻辑流程图700、800、900描述的操作可实现为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/或软件和硬件的组合。在一个实施例中，用于执行逻辑流程图700、800、900描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中描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监控并评价可从发生器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了变化。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的操作模式可通过使用者控制，或者可自动或半自动地控制。
图15A示出了确定组织状态的变化和因此激活输出指示器412的一个实施例的逻辑流程图700。现在参照图15A中示出的逻辑流程图700以及图9中示出的发生器30的驱动系统32，在702，驱动系统32的处理器400部分采样发生器30的电压(v)、电流(i)和频率(f)信号。在图示实施例中，在704中，频率和电压信号样本被分开分析，以确定对应的频率拐点和/或电压降点。在其它实施例中，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和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“No”分支到达702并从发生器30中读取额外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读取额外的电流信号样本。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“Yes”分支到达718，并激活输出指示器412。
如先前的讨论，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可手动、自动或半自动地控制。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。响应于组织状态的变化的超声器械的操作模式可被选定为(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。这是非常有利的，这是因为当在端部执行器81、810的夹具之间没有物质的情况下激活换能器50时，热成指数增长，如同组织状态发生变化的情况一样。
图15B是显示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接纳。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。根据频率移动平均公式806和α值(α)808计算EWMA：
Stf＝αYtf+(1-α)Stf-1          (2)
式中：
Stf＝采样的频率信号的当前移动平均值；
Stf-1＝采样的频率信号的前一个移动平均值；
α＝平滑因数；以及
Ytf＝采样的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可根据超声器械类型和功率电平选择。在一个实施例中，块804、806和808可实现为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，频率样本的斜率就在812中计算，如下：
频率斜率＝Δf/Δt            (3)
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的实施可以如下实现：通过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)
式中：
S′tf＝采样的频率信号的频率斜率的当前移动平均值；
S′tf-1＝采样的频率信号的频率斜率的前一个移动平均值；
α′＝平滑因数；以及
Y′tf＝采样的频率信号的当前斜率数据点。
如先前参照数字滤波块810的讨论，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可根据超声器械类型和功率电平选择。
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。
在图示实施例中，“慢速响应”移动平均值滤波器814的输出“斜率EWMA”施加至加法器828的(+)输入，且“快速响应”滤波器816的输出“斜率Avg”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。这些输出之间的差在830与预定极限832比较。极限832的确定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”之间的差不大于极限832，则处理器400沿着“No”分支继续并将值834返回到结果710块，其指示在采样的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。但是，如果“斜率EWMA”和“斜率Avg”之间的差大于极限832，则处理器400沿着“Yes”分支继续并确定找到频率拐点836，然后将点索引838返回到结果710块，其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。如先前参照图15A的描述，如果发现频率拐点836，然后在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)
式中：
Stv＝采样的电压信号的当前移动平均值；
Stv-1＝采样的电压信号的前一个移动平均值；
α＝平滑因数；以及
Ytv＝采样的电压信号的当前数据点。
如先前的讨论，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选择。在一个实施例中，块904、906和908可实现为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，电压样本的斜率在912中计算，如下：
电压斜率＝Δv/Δt                    (6)
计算的电压斜率数据点被提供至“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的实施可以如下实现：通过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)
式中：
S′tv＝采样的电压信号的电压斜率的当前移动平均值；
S′tv-1＝采样的电压信号的电压斜率的前一个移动平均值；
α′＝平滑因数；以及
Y′tv＝采样的电压信号的当前斜率数据点。
如先前参照数字滤波块910的讨论，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可根据超声器械类型和功率电平选择。
计算的电压斜率数据点提供至“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。
在图示实施例中，“慢速响应”移动平均值滤波器914的输出“斜率EWMA”施加至加法器928的(+)输入，且“快速响应”滤波器916的输出“斜率Avg”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。这些输出之间的差在930与预定极限932比较。极限932的确定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932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”之间的差不大于极限932，则处理器400沿着“No”分支继续并在940将计数器复位为零，然后将值934返回到结果710块，其指示在采样的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。但是，如果“斜率EWMA”和“斜率Avg”之间的差大于极限932，则处理器400沿着“Yes”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，在图示实施例中为1)，则处理器400继续沿着“No”分支前进并将值934返回到结果710块，其指示在采样的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，在图示实施例中为1)，则处理器400继续沿着“Yes”分支前进并确定找到电压降点936，然后将点索引938返回到结果712块，其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。根据先前参照图15A的讨论，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。
虽然已经示出并描述了若干实施例，但是申请人的意图不是将权利要求的范围约束或限制在这些细节中。在不脱离本发明的范围的条件下，本领域的技术人员可以进行许多变型、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一个元件的结构描述为用于提供由该元件实现的功能的方式。因此，所描述的实施例旨在仅受所附权利要求书的范围的限制。
在整篇说明书中引用的“各实施例”、“一些实施例”、“一个实施例”或“实施例”意味着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，可按照任何合适的方式组合特定特征、结构或特性。因此，在不限制的情况下，结合一个实施例示出或描述的特定特征、结构或特性可全部或部分地与一个或多个其它实施例的特征、结构或特性结合。

Claims (19)

1.一种用于驱动连接至外科器械的超声驱动系统的端部执行器的方法，其中所述超声驱动系统构造为以谐振频率谐振，所述超声驱动系统包括连接至波导的超声换能器和连接至所述波导的端部执行器，所述方法包括：
通过连接至超声驱动系统的发生器产生不同于所述谐振频率的第一频率的第一超声驱动信号，且；
在第一周期，利用所述第一频率的第一超声驱动信号致动所述超声换能器，以为所述端部执行器提供适于将第一组织与第二组织分离的第一水平的机械振动；
通过发生器产生所述谐振频率的第二超声驱动信号；以及
在所述第一周期之后的第二周期，利用所述谐振频率的第二超声驱动信号致动所述超声换能器，以为所述端部执行器提供适于横切和密封第一组织的第二水平的机械振动；
其中在对应的第一和第二周期中，所述第一超声驱动信号不同于所述第二超声驱动信号；并且
其中在所述第一和第二周期中，所述第一和第二超声驱动信号定义阶跃函数波形。
2.根据权利要求1所述的方法，包括：
通过所述发生器产生第三超声驱动信号；以及
在第三周期，利用所述第三超声驱动信号致动所述超声换能器；
其中在所述第一、第二和第三周期中，所述第三超声驱动信号不同于所述第一和第二超声驱动信号；并且
其中在所述第一、第二和第三周期中，所述第一、第二和第三超声驱动信号定义阶跃函数波形。
3.根据权利要求2所述的方法，其中：
产生所述第一、第二和第三超声驱动信号包括产生对应的第一、第二和第三驱动电流；并且
致动所述超声换能器包括：
在所述第一周期，利用所述第一驱动电流致动所述超声换能器；
在所述第二周期，利用所述第二驱动电流致动所述超声换能器；以及
在所述第三周期，利用所述第三驱动电流致动所述超声换能器。
4.根据权利要求1所述的方法，其中所述第一频率基本上不同于所述谐振频率，并且所述第一周期短于一秒。
5.根据权利要求4所述的方法，其中所述第一频率通过以下公式定义：
f1＝2*fo；
其中f1为所述第一频率，并且
其中fo为所述谐振频率。
6.根据权利要求4所述的方法，其中所述第一频率通过以下公式定义：
f1＝fo/2；
其中f1为所述第一频率，并且
其中fo为所述谐振频率。
7.根据权利要求1所述的方法，包括在第一周期之后，以谐振频率自动地产生第二超声驱动信号。
8.根据权利要求1所述的方法，包括：
监控所述超声驱动系统的可测量特性；以及
基于测量到的特性产生所述第一和第二超声驱动信号中的任一个。
9.根据权利要求8所述的方法，其中所述可测量特性是所述超声换能器的阻抗。
10.根据权利要求8所述的方法，其中所述可测量特性是接触所述端部执行器的组织部分的阻抗。
11.根据权利要求10所述的方法，包括：
产生亚治疗射频(RF)信号；
将所述RF信号施加至所述组织部分；以及
测量所述组织部分的阻抗。
12.一种用于驱动连接至外科超声器械的超声驱动系统的端部执行器的设备，所述设备包括：
发生器，其被构造为连接至超声器械的超声驱动系统，所述超声驱动系统包括连接至波导的超声换能器和连接至所述波导的端部执行器；
其中所述发生器被构造为：
产生第一频率的第一超声驱动信号；
在第一周期，利用所述第一频率的第一超声驱动信号致动所述超声换能器，以为所述端部执行器提供适于将第一组织与第二组织分离的第一水平的机械振动；
通过所述发生器产生不同于所述第一频率的谐振频率的第二超声驱动信号；以及
在所述第一周期之后的第二周期，利用所述谐振频率的第二超声驱动信号致动所述超声换能器，以为所述端部执行器提供适于横切和密封第一组织的第二水平的机械振动；
其中在对应的第一和第二周期中，所述第一超声驱动信号不同于所述第二超声驱动信号；并且
其中在所述第一和第二周期中，所述第一和第二超声驱动信号定义阶跃函数波形。
13.根据权利要求12所述的设备，包括用以监控所述超声驱动系统的可测量特性的测量模块，其中所述发生器被构造为基于测量到的特性产生所述第一和第二超声驱动信号中的任一个。
14.根据权利要求13所述的设备，其中所述测量模块包括：
射频(RF)发生器，其连接至所述端部执行器，所述射频发生器被构造为用以产生亚治疗RF信号；以及
夹持臂组件，其连接至所述超声驱动系统的远端，所述夹持臂组件包括形成连接至RF发生器的返回电极的导电性部分，所述夹持臂组件被操作性地连接至所述端部执行器以抓紧它们之间的组织。
15.根据权利要求13所述的设备，其中所述测量模块包括：
电压感测模块；
电流感测模块；
模数转换器(ADC)，其连接至所述电压感测模块和所述电流感测模块；以及
处理器，其连接至ADC，所述处理器被构造为测量阻抗。
16.一种用于驱动连接至外科器械的超声系统的端部执行器的系统，所述系统包括：
发生器；以及
超声器械，其包括连接至所述发生器的超声驱动系统，所述超声驱动系统包括连接至波导的超声换能器和连接至所述波导的端部执行器；
其中所述发生器被构造为：
产生第一频率的第一超声驱动信号；
在第一周期，利用所述第一频率的第一超声驱动信号致动所述超声换能器，以为所述端部执行器提供适于将第一组织与第二组织分离的第一水平的机械振动；
通过所述发生器产生不同于所述第一频率的谐振频率的第二超声驱动信号；以及
在所述第一周期之后的第二周期，利用所述谐振频率的第二超声驱动信号致动所述超声换能器，以为所述端部执行器提供适于横切和密封第一组织的第二水平的机械振动；
其中在对应的第一和第二周期中，所述第一超声驱动信号不同于所述第二超声驱动信号；并且
其中在所述第一和第二周期中，所述第一和第二超声驱动信号定义阶跃函数波形。
17.根据权利要求16所述的系统，其中所述发生器包括用以监控所述超声驱动系统的可测量特性的测量模块，其中所述发生器被构造为基于测量到的特性产生所述第一和第二超声驱动信号中的任一个。
18.根据权利要求17所述的系统，其中所述测量模块包括：
射频(RF)发生器，其连接至所述端部执行器，所述射频发生器被构造为用以产生亚治疗RF信号；以及
夹持臂组件，其连接至所述超声驱动系统的远端，所述夹持臂组件包括形成连接至RF发生器的返回电极的导电性部分，所述夹持臂组件被操作性地连接至所述端部执行器以抓紧它们之间的组织。
19.根据权利要求17所述的系统，其中所述测量模块包括：
电压感测模块；
电流感测模块；
模数转换器(ADC)，其连接至所述电压感测模块和所述电流感测模块；以及
处理器，其连接至ADC，所述处理器被构造为测量阻抗。
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US8058771B2 (en) 2011-11-15
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US20130035706A1 (en) 2013-02-07
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