CN111818863A - 用于组织分类的精细解剖模式 - Google Patents

用于组织分类的精细解剖模式 Download PDF

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Publication number
CN111818863A
CN111818863A CN201980017932.8A CN201980017932A CN111818863A CN 111818863 A CN111818863 A CN 111818863A CN 201980017932 A CN201980017932 A CN 201980017932A CN 111818863 A CN111818863 A CN 111818863A
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China
Prior art keywords
tissue
end effector
generator
amount
instrument
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CN201980017932.8A
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Inventor
K·G·登津格
M·C·杰梅
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Ethicon LLC
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Ethicon LLC
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Abstract

本发明涉及一种基于外科技术控制向射频(RF)器械施加能量的方法，所述方法可以包括：激活所述器械持续第一时间段T1，在所述第一时间段的时间内，端部执行器的一部分接触组织；绘制与所述组织相关联的至少两个电参数以对所述端部执行器的与所述组织接触的量进行分类；应用分类算法以对所述端部执行器的与所述组织接触的所述量进行分类；以及基于所述端部执行器的与所述组织接触的所述量向所述端部执行器施加一定量的能量。所述参数可以包括所述组织的最小阻抗和阻抗斜率约为0时的时间量。所述端部执行器可以使末端端部或整个表面接触组织。

Description

用于组织分类的精细解剖模式
相关申请的交叉引用
本申请要求2018年9月27日提交的标题为“FINE DISSECTION MODE FOR TISSUECLASSIFICATION”的美国专利申请序列号16/144,508的优先权权益，该美国专利申请的公开内容全文以引用方式并入本文。
本申请要求2018年3月8日提交的标题为“TEMPERATURE CONTROL IN ULTRASONICDEVICE AND CONTROL SYSTEM THEREFOR”的美国临时专利申请序列号62/640,417和2018年3月8日提交的标题为“ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROLSYSTEM THEREFOR”的美国临时专利申请序列号62/640,415的优先权权益，这些临时专利申请中的每个的公开内容全文以引用方式并入本文。
背景技术
在外科环境中，智能能量装置可需要在智能能量架构环境中。超声外科装置诸如超声手术刀，因其独特的性能特征而用于外科手术的多种应用中。根据具体的装置配置和操作参数，超声外科装置可大体上同时提供组织的横切和通过凝固止血，从而有利地使患者创伤最小化。超声外科装置可包括包含超声换能器的手持件，以及联接到超声换能器的器械，该超声换能器具有安装在远侧的端部执行器(例如，刀末端)以切割并密封组织。在一些情况下，器械可永久性地附连到手持件。在其他情况下，器械可为可从手持件拆卸的，如在一次性器械或可互换器械的情况下。端部执行器将超声能量传输到与端部执行器进行接触的组织，以实现切割和密封动作。具有该性质的超声外科装置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，包括机器人辅助的手术。
超声能量使用低于电外科手术中所用的温度来切割并凝固组织，并且可通过与手持件连通的超声发生器将超声能量传输到端部执行器。在以高频振动(例如，每秒55,500个循环)的情况下，超声刀使组织中的蛋白变性，以形成粘性凝固物。刀表面施加在组织上的压力使血管塌缩并使该凝固物形成止血密封。外科医生可通过由端部执行器施加到组织的力、施加该力的时间以及端部执行器的选定偏移水平来控制切割速度和凝固。
超声换能器可被建模成等效电路，该等效电路包括具有静态电容的第一支路和具有串联连接的电感、电阻和电容的第二“动态”支路，该电感、电阻和电容限定谐振器的机电特性。已知的超声发生器可包括调谐电感器，该调谐电感器用于解谐处于谐振频率的静态电容，使得大体上发生器的驱动信号电流中的全部均流入动态支路中。因此，通过使用调谐电感器，发生器的驱动信号电流表示动态支路电流，并且因此发生器能够控制其驱动信号以保持超声换能器的谐振频率。调谐电感器还可变换超声换能器的相位阻抗曲线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在操作谐振频率下的特定静态电容匹配。换句话讲，具有不同静态电容的不同超声换能器需要不同的调谐电感器。
另外，在一些超声发生器架构中，发生器的驱动信号呈现非对称谐波失真，这使阻抗幅值和相位测量复杂化。例如，阻抗相位测量的准确性可由于电流和电压信号中的谐波失真而减小。
此外，噪声环境中的电磁干扰会降低发生器保持对超声换能器的谐振频率的锁定的能力，从而增加无效控制算法输入的可能性。
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。电外科装置包括手持件和具有远侧安装的端部执行器(例如，一个或多个电极)的器械。该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用于双极或单极操作。在双极操作期间，电流分别通过端部执行器的有源电极和返回电极被引入到组织中并从组织返回。在单极操作期间，电流通过端部执行器的有源电极被引入组织中并且通过单独定位在患者身体上的返回电极(例如，接地垫)返回。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还可包括能够相对于组织运动的切割构件以及用于横切组织的电极。
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输至器械。电能可为射频(RF)能量的形式。RF能量是可在300kHz至1MHz的频率范围内的电能形式，如EN60601-2-2:2009+A11:2011，定义201.3.218-高频中所述。例如，单极RF应用中的频率通常被限制为小于5MHz。然而，在双极RF应用中，频率几乎可为任何值。单极应用通常使用高于200kHz的频率，以便避免由于使用低频电流而产生不希望的对神经和肌肉的刺激。如果风险分析显示神经肌肉刺激的可能性已减轻至可接受的水平，则双极技术可使用更低频率。通常，不使用高于5MHz的频率以最小化与高频渗漏电流相关联的问题。通常认为，10mA是组织热效应的下限阈值。
在其操作期间，电外科装置可穿过组织传输低频RF能量，这会引起离子振动或摩擦，并实际上引起电阻性加热，从而升高组织的温度。由于可在受影响的组织和周围组织之间形成尖锐边界，因此外科医生能够以高精确度水平进行操作，并在不损伤相邻的非目标组织的情况下进行控制。RF能量的低操作温度可适用于在密封血管的同时移除软组织、收缩软组织、或对软组织塑型。RF能量可尤其良好地适用于结缔组织，该结缔组织主要由胶原构成，并在接触热时收缩。
由于其独特的驱动信号、感测和反馈需求，超声和电外科装置通常需要不同的发生器。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配置以及相应地优化控制和诊断过程的能力受限。此外，发生器的非隔离电路和患者隔离电路之间的电容耦合，尤其是在使用更高电压和频率的情况下，可导致患者暴露于不可接受的泄漏电流水平。
此外，由于其独特的驱动信号、感测和反馈需要，超声和电外科装置通常需要用于不同发生器的不同用户界面。在此类常规超声和电外科装置中，一个用户界面被配置用于与超声器械一起使用，而另一个用户界面可被配置用于与电外科器械一起使用。此类用户界面包括手和/或脚激活的用户界面，诸如手激活交换器和/或脚激活交换器。由于在随后的公开中设想了与超声外科器械和电外科器械一起使用的组合发生器的各个方面，因此还设想了被配置成能够与超声和/或电外科器械发生器一起操作的附加用户界面。
在后续公开中设想用于向用户或其他机器提供反馈的附加用户界面，以提供指示超声和/或电外科器械的操作模式或状态的反馈。提供用于操作超声和/或电外科器械的组合的用户和/或机器反馈将需要向用户提供感觉反馈以及向机器提供电/机械/机电反馈。在后续公开中设想并入用于组合超声和/或电外科器械的视觉反馈装置(例如，LCD显示屏、LED指示器)、音频反馈装置(例如，扬声器、蜂鸣器)或触觉反馈装置(例如，触觉致动器)的反馈装置。
其他电外科器械包括但不限于不可逆和/或可逆电穿孔、和/或微波技术等等。因此，本文所公开的技术可适用于超声、双极或单极RF(电外科)、不可逆和/或可逆电穿孔、和/或基于微波的外科器械等等。
发明内容
基于外科技术控制向射频(RF)器械施加能量的方法的一个方面可以包括由处理器或控制电路激活所述射频(RF)器械持续第一时间段T1，其中所述RF器械的端部执行器的一部分在至少所述第一时间段T1内接触组织，由所述处理器或所述控制电路绘制与跟所述RF器械接触的所述组织相关联的至少两个电参数以对所述端部执行器的与所述组织接触的量进行分类，由所述处理器或所述控制电路应用分类算法以对所述端部执行器的与所述组织接触的所述量进行分类，以及由所述处理器或所述控制电路基于所述端部执行器的与所述组织接触的所述量向所述端部执行器施加一定量的能量。
在所述方法的一个方面，由所述处理器或所述控制电路绘制与跟所述RF器械接触的所述组织相关联的至少两个电参数可以包括：由所述处理器或所述控制电路绘制所述组织的最小RF阻抗，和RF阻抗斜率约为0时的以毫秒为单位的时间量。
在一个方面，所述方法还可以包括由所述处理器或所述控制电路在预定时间量内收集与所述至少两个电参数相关联的数据。
在所述方法的一个方面，由所述处理器或所述控制电路在预定时间量内收集与所述至少两个电参数相关联的数据可以包括：由所述处理器或所述控制电路在激活所述射频(RF)器械之后的最初0.75秒内收集与所述至少两个电参数相关联的数据。
在所述方法的一个方面，由所述处理器或所述控制电路应用分类算法以对所述端部执行器的与所述组织接触的所述量进行分类可以包括：由所述处理器或所述控制电路应用分类算法以使用支持向量机算法对所述端部执行器的与所述组织接触的所述量进行分类。
在所述方法的一个方面，由所述处理器或所述控制电路应用分类算法以使用支持向量机算法对所述端部执行器的与所述组织接触的所述量进行分类可以包括：由所述处理器或所述控制电路应用分类算法以使用线性基函数、多项式基函数或径向基函数对所述端部执行器的与所述组织接触的所述量进行分类。
在一个方面，所述方法还可以包括由所述处理器或所述控制电路在所述第一时间段T1之后应用特定于所述端部执行器的与所述组织接触的所述量的激活算法。
在所述方法的一个方面，由所述处理器或所述控制电路应用分类算法以对所述端部执行器的与所述组织接触的所述量进行分类可以包括：由所述处理器或所述控制电路应用分类算法以对所述端部执行器的与所述组织接触的所述量进行分类，其中所述分类可以包括第一组或第二组，所述第一组包括所述端部执行器的与所述组织接触的末端端部，在所述第二组中所述端部执行器的整个表面与所述组织接触。
外科器械的一个方面可以包括：具有端部执行器的射频(RF)器械，以及被配置成能够向所述端部执行器供应功率的发生器。所述发生器的一个方面可以包括控制电路，所述控制电路被配置成能够激活所述射频(RF)器械持续第一时间段T1，其中所述端部执行器的一部分在至少所述第一时间段T1内接触组织，绘制与跟所述RF器械接触的所述组织相关联的至少两个电参数以对所述端部执行器的与所述组织接触的量进行分类，应用分类算法以对所述端部执行器的与所述组织接触的所述量进行分类，以及基于所述端部执行器的与所述组织接触的所述量向所述端部执行器施加一定量的能量。
在所述外科器械的一个方面，与跟所述RF器械接触的所述组织相关联的所述至少两个电参数可以包括所述组织的初始RF阻抗和RF阻抗斜率约为0时的以毫秒为单位的时间量。
在所述外科器械的一个方面，所述控制电路还被配置成能够在预定时间量内收集与所述至少两个电参数相关联的数据。
在所述外科器械的一个方面，所述预定时间量包括在激活所述射频(RF)器械之后的最初0.75秒。
在所述外科器械的一个方面，所述控制电路还被配置成能够使用支持向量机算法对所述端部执行器的与所述组织接触的所述量进行分类。
在所述外科器械的一个方面，所述支持向量机算法包括线性基函数、多项式基函数或径向基函数。
在所述外科器械的一个方面，所述控制电路还被配置成能够在所述第一时间段T1之后应用特定于所述端部执行器的与所述组织接触的所述量的激活算法。
在所述外科器械的一个方面，所述分类算法被配置成能够将所述端部执行器的与所述组织接触的所述量分类为第一组或第二组，在所述第一组中，所述端部执行器的末端端部接触所述组织，在所述第二组中，所述端部执行器的整个表面接触所述组织。
用于外科器械的发生器的一个方面可以包括控制电路，所述外科器械包括具有端部执行器的射频(RF)器械。所述控制电路的一个方面可以被配置成能够激活所述射频(RF)器械持续第一时间段T1，其中所述端部执行器的一部分在至少所述第一时间段T1内接触组织，绘制与跟所述RF器械接触的所述组织相关联的至少两个电参数以对所述端部执行器的与所述组织接触的量进行分类，应用分类算法以对所述端部执行器的与所述组织接触的所述量进行分类，以及基于所述端部执行器的与所述组织接触的所述量向所述端部执行器施加一定量的能量。
在所述发生器的一个方面，与跟所述RF器械接触的所述组织相关联的所述至少两个电参数可以包括所述组织的初始RF阻抗和RF阻抗斜率约为0时的以毫秒为单位的时间量。
在所述发生器的一个方面，所述控制电路还被配置成能够在预定时间量内收集与所述至少两个电参数相关联的数据。
在所述发生器的一个方面，所述预定时间量可以包括在激活所述射频(RF)器械之后的最初0.75秒。
在所述发生器的一个方面，所述控制电路还被配置成能够使用支持向量机算法对所述端部执行器的与所述组织接触的所述量进行分类。
在所述发生器的一个方面，所述支持向量机算法包括线性基函数、多项式基函数或径向基函数。
在所述发生器的一个方面，所述控制电路还被配置成能够在所述第一时间段T1之后应用特定于所述端部执行器的与所述组织接触的所述量的激活算法。
在所述发生器的一个方面，所述分类算法被配置成能够将所述端部执行器的与所述组织接触的所述量分类为第一组或第二组，在所述第一组中，所述端部执行器的末端端部接触所述组织，在所述第二组中，所述端部执行器的整个表面接触所述组织。
附图说明
各个方面的特征在所附权利要求书中进行了特别描述。然而，通过参考以下结合如下附图所作的说明可最好地理解各个方面(有关手术组织和方法)及其进一步的目的和优点。
图1为根据本公开的至少一个方面的被配置成能够在包括模块化通信集线器的外科数据网络中执行自适应超声刀控制算法的系统。
图2示出了根据本公开的至少一个方面的发生器的示例。
图3为根据本公开的至少一个方面的外科系统，该外科系统包括发生器和能够与其一起使用的各种外科器械。
图4为根据本公开的至少一个方面的端部执行器。
图5为根据本公开的至少一个方面的图3的外科系统的图示。
图6为根据本公开的至少一个方面的示出动态支路电流的模型。
图7为根据本公开的至少一个方面的发生器架构的结构视图。
图8A至图8C为根据本公开的至少一个方面的发生器架构的功能视图。
图9A至图9B为根据本公开的至少一个方面的发生器的结构和功能方面。
图10示出了根据本公开的至少一个方面的被配置成能够控制外科器械或工具的各方面的控制电路。
图11示出了根据本公开的至少一个方面的被配置成能够控制外科器械或工具的各方面的组合逻辑电路。
图12示出了根据本公开的至少一个方面的被配置成能够控制外科器械或工具的各方面的时序逻辑电路。
图13示出了根据本公开的至少一个方面的数字合成电路诸如直接数字合成(DDS)电路的基本架构的一个方面，该DDS电路被配置成能够生成用于外科器械中的电信号波形的多个波形状。
图14示出了根据本公开的至少一个方面的直接数字合成(DDS)电路的一个方面，该DDS电路被配置成能够生成用于外科器械中的电信号波形的多个波形状。
图15示出了根据本公开的至少一个方面的根据模拟波形(被示出为叠加在离散时间数字电信号波形之上以用于比较目的)的本公开的至少一个方面的离散时间数字电信号的一个循环。
图16为根据本公开的一个方面的控制系统的图示。
图17示出了根据本公开的一个方面的比例积分微分(PID)控制器反馈控制系统。
图18为根据本公开的至少一个方面的用于控制超声机电系统的频率并且检测其阻抗的替代系统。
图19为根据本公开的至少一个方面的同一超声装置在端部执行器的各种不同状态和状况下的光谱图，其中超声换能器的阻抗的相位和幅值被绘制为频率的函数。
图20为根据本公开的至少一个方面的一组3D训练数据S的曲线图的图形表示，其中超声换能器阻抗幅值和相位被绘制为频率的函数。
图21为根据本公开的至少一个方面的描绘基于复阻抗特征图案(指纹)来确定钳口状况的控制程序或逻辑配置的逻辑流程图。
图22为根据本公开的至少一个方面的被绘制为压电振动器的虚分量与实分量之间的关系的复阻抗的圆图。
图23为根据本公开的至少一个方面的被绘制为压电振动器的虚分量与实分量之间的关系的复导纳的圆图。
图24为55.5kHz超声压电换能器的复导纳的圆图。
图25为根据本公开的至少一个方面的阻抗分析仪的图形显示，示出了钳口打开且无负载的超声装置的阻抗/导纳圆图，其中复导纳以虚线描绘，并且复阻抗以实线描绘。
图26为根据本公开的至少一个方面的阻抗分析仪的图形显示，示出了钳口被夹持在干燥油鞣革(chamois)上的超声装置的阻抗/导纳圆图，其中复导纳以虚线描绘，并且复阻抗以实线描绘。
图27为根据本公开的至少一个方面的阻抗分析仪的图形显示，示出了钳口末端被夹持在潮湿油鞣革上的超声装置的阻抗/导纳圆图，其中复导纳以虚线描绘，并且复阻抗以实线描绘。
图28为根据本公开的至少一个方面的阻抗分析仪的图形显示，示出了钳口被完全夹持在潮湿油鞣革上的超声装置的阻抗/导纳圆图，其中复导纳以虚线描绘，并且复阻抗以实线描绘。
图29为根据本公开的至少一个方面的阻抗分析仪的图形显示，示出了其中扫描从48kHz到62kHz的频率以捕获钳口打开的超声装置的多个谐振的阻抗/导纳图，其中以虚线示出的矩形叠层有助于看到圆。
图30为根据本公开的至少一个方面的描绘基于阻抗/导纳圆的半径和偏移的评估值来确定钳口状况的控制程序或逻辑配置的过程的逻辑流程图。
图31为根据本公开的至少一个方面的组织射频(RF)阻抗分类的三维图形表示。
图32为根据本公开的至少一个方面的组织射频(RF)阻抗分析的三维图形表示。
图33为根据本公开的至少一个方面的颈动脉技术敏感性的图形表示，其中时间阻抗(Z)导数被绘制为初始射频(RF)阻抗的函数。
具体实施方式
本专利申请的申请人还拥有于2018年9月27日提交的以下美国专利申请，这些专利申请中的每个全文以引用方式并入本文：
·标题为“METHODS FOR CONTROLLING TEMPERATURE IN ULTRASONIC DEVICE”、代理人案卷号为END8560USNP1/180106-1M的美国临时专利申请；
·标题为“ULTRASONIC SEALING ALGORITHM WITH TEMPERATURE CONTROL”、代理人案卷号为END8560USNP3/180106-3的美国临时专利申请；
·标题为“APPLICATION OF SMART ULTRASONIC BLADE TECHNOLOGY”、代理人案卷号为END8560USNP4/180106-4的美国临时专利申请；
·标题为“ADAPTIVE ADVANCED TISSUE TREATMENT PAD SAVER MODE”、代理人案卷号为END8560USNP5/180106-5的美国临时专利申请；
·标题为“SMART BLADE TECHNOLOGY TO CONTROL BLADE INSTABILITY”、代理人案卷号为END8560USNP6/180106-6的美国临时专利申请；以及
·标题为“START TEMPERATURE OF BLADE”、代理人案卷号为END8560USNP7/180106-7的美国临时专利申请。
本专利申请的申请人还拥有于2018年9月27日提交的以下美国专利申请，这些专利申请中的每个全文以引用方式并入本文：
·标题为“METHODS FOR ESTIMATING AND CONTROLLING STATE OF ULTRASONICEND EFFECTOR”、代理人案卷号为END8536USNP1/180107-1M的美国临时专利申请；
·标题为“IN-THE-JAW CLASSIFIER BASED ON MODEL”、代理人案卷号为END8536USNP3/180107-3的美国临时专利申请；
·标题为“APPLICATION OF SMART BLADE TECHNOLOGY”、代理人案卷号为END8536USNP4/180107-4的美国临时专利申请；
·标题为“SMART BLADE AND POWER PULSING”、代理人案卷号为END8536USNP5/180107-5的美国临时专利申请；
·标题为“ADJUSTMENT OF COMPLEX IMPEDANCE TO COMPENSATE FOR LOST POWERIN AN ARTICULATING ULTRASONIC DEVICE”、代理人案卷号为END8536USNP6/180107-6的美国临时专利申请；
·标题为“USING SPECTROSCOPY TO DETERMINE DEVICE USE STATE IN COMBOINSTRUMENT”、代理人案卷号为END8536USNP7/180107-7的美国临时专利申请；
·标题为“VESSEL SENSING FOR ADAPTIVE ADVANCED HEMOSTASIS”、代理人案卷号为END8536USNP8/180107-8的美国临时专利申请；
·标题为“CALCIFIED VESSEL IDENTIFICATION”、代理人案卷号为END8536USNP9/180107-9的美国临时专利申请；
·标题为“DETECTION OF LARGE VESSELS DURING PARENCHYMAL DISSECTIONUSING A SMART BLADE”、代理人案卷号为END8536USNP10/180107-10的美国临时专利申请；
·标题为“SMART BLADE APPLICATION FOR REUSABLE AND DISPOSABLEDEVICES”、代理人案卷号为END8536USNP11/180107-11的美国临时专利申请；以及
·标题为“LIVE TIME TISSUE CLASSIFICATION USING ELECTRICALPARAMETERS”、代理人案卷号为END8536USNP12/180107-12的美国临时专利申请。
本申请的申请人拥有于2018年9月10日提交的以下美国专利申请，这些专利申请中的每个的公开内容全文以引用方式并入本文：
·美国临时专利申请序列号62/729,177，其标题为“AUTOMATED DATA SCALING,ALIGNMENT,AND ORGANIZING BASED ON PREDEFINED PARAMETERS WITHIN A SURGICALNETWORK BEFORE TRANSMISSION”；
·美国临时专利申请序列号62/729,182，其标题为“SENSING THE PATIENTPOSITION AND CONTACT UTILIZING THE MONO POLAR RETURN PAD ELECTRODE TO PROVIDESITUATIONAL AWARENESS TO THE HUB”；
·美国临时专利申请序列号62/729,184，其标题为“POWERED SURGICAL TOOLWITH A PREDEFINED ADJUSTABLE CONTROL ALGORITHM FOR CONTROLLING AT LEAST ONEEND EFFECTOR PARAMETER AND A MEANS FOR LIMITING THE ADJUSTMENT”；
·美国临时专利申请序列号62/729,183，其标题为“SURGICAL NETWORKRECOMMENDATIONS FROM REAL TIME ANALYSIS OF PROCEDURE VARIABLES AGAINST ABASELINE HIGHLIGHTING DIFFERENCES FROM THE OPTIMAL SOLUTION”；
·美国临时专利申请序列号62/729,191，其标题为“A CONTROL FOR A SURGICALNETWORK OR SURGICAL NETWORK CONNECTED DEVICE THAT ADJUSTS ITS FUNCTION BASEDON A SENSED SITUATION OR USAGE”；
·美国临时专利申请序列号62/729,176，其标题为“INDIRECT COMMAND ANDCONTROL OF A FIRST OPERATING ROOM SYSTEM THROUGH THE USE OF A SECONDOPERATING ROOM SYSTEM WITHIN A STERILE FIELD WHERE THE SECOND OPERATING ROOMSYSTEM HAS PRIMARY AND SECONDARY OPERATING MODES”；
·美国临时专利申请序列号62/729,186，其标题为“WIRELESS PAIRING OF ASURGICAL DEVICE WITH ANOTHER DEVICE WITHIN A STERILE SURGICAL FIELD BASED ONTHE USAGE AND SITUATIONAL AWARENESS OF DEVICES”；以及
·美国临时专利申请序列号62/729,185，其标题为“POWERED STAPLING DEVICETHAT IS CAPABLE OF ADJUSTING FORCE,ADVANCEMENT SPEED,AND OVERALL STROKE OFCUTTING MEMBER OF THE DEVICE BASED ON SENSED PARAMETER OF FIRING ORCLAMPING”。
本申请的申请人拥有于2018年8月28日提交的以下美国专利申请，这些专利申请中的每个的公开内容全文以引用方式并入本文：
·美国专利申请序列号16/115,214，其标题为“ESTIMATING STATE OFULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR”；
·美国专利申请序列号16/115,205，其标题为“TEMPERATURE CONTROL OFULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR”；
·美国专利申请序列号16/115,233，其标题为“RADIO FREQUENCY ENERGY DEVICEFOR DELIVERING COMBINED ELECTRICAL SIGNALS”；
·美国专利申请序列号16/115,208，其标题为“CONTROLLING AN ULTRASONICSURGICAL INSTRUMENT ACCORDING TO TISSUE LOCATION”；
·美国专利申请序列号16/115,220，其标题为“CONTROLLING ACTIVATION OF ANULTRASONIC SURGICAL INSTRUMENT ACCORDING TO THE PRESENCE OF TISSUE”；
·美国专利申请序列号16/115,232，其标题为“DETERMINING TISSUECOMPOSITION VIA AN ULTRASONIC SYSTEM”；
·美国专利申请序列号16/115,239，其标题为“DETERMINING THE STATE OF ANULTRASONIC ELECTROMECHANICAL SYSTEM ACCORDING TO FREQUENCY SHIFT”；
·美国专利申请序列号16/115,247，其标题为“DETERMINING THE STATE OF ANULTRASONIC END EFFECTOR”；
·美国专利申请序列号16/115,211，其标题为“SITUATIONAL AWARENESS OFELECTROSURGICAL SYSTEMS”；
·美国专利申请序列号16/115,226，其标题为“MECHANISMS FOR CONTROLLINGDIFFERENT ELECTROMECHANICAL SYSTEMS OF AN ELECTROSURGICAL INSTRUMENT”；
·美国专利申请序列号16/115,240，其标题为“DETECTION OF END EFFECTOREMERSION IN LIQUID”；
·美国专利申请序列号16/115,249，其标题为“INTERRUPTION OF ENERGY DUE TOINADVERTENT CAPACITIVE COUPLING”；
·美国专利申请序列号16/115,256，其标题为“INCREASING RADIO FREQUENCY TOCREATE PAD-LESS MONOPOLAR LOOP”；
·美国专利申请序列号16/115,223，其标题为“BIPOLAR COMBINATION DEVICETHAT AUTOMATICALLY ADJUSTS PRESSURE BASED ON ENERGY MODALITY”；以及
·美国专利申请序列号16/115,238，其标题为“ACTIVATION OF ENERGYDEVICES”。
本申请的申请人拥有于2018年8月23日提交的以下美国专利申请，这些专利申请中的每个的公开内容全文以引用方式并入本文：
·美国临时专利申请号62/721,995，其标题为“CONTROLLING AN ULTRASONICSURGICAL INSTRUMENT ACCORDING TO TISSUE LOCATION”；
·美国临时专利申请号62/721,998，其标题为“SITUATIONAL AWARENESS OFELECTROSURGICAL SYSTEMS”；
·美国临时专利申请号62/721,999，其标题为“INTERRUPTION OF ENERGY DUE TOINADVERTENT CAPACITIVE COUPLING”；
·美国临时专利申请62/721,994，其标题为“BIPOLAR COMBINATION DEVICE THATAUTOMATICALLY ADJUSTS PRESSURE BASED ON ENERGY MODALITY”；以及
·美国临时专利申请号62/721,996，其标题为“RADIO FREQUENCY ENERGY DEVICEFOR DELIVERING COMBINED ELECTRICAL SIGNALS”。
本申请的申请人拥有于2018年6月30日提交的以下美国专利申请，这些专利申请中的每个的公开内容全文以引用方式并入本文：
·美国临时专利申请号62/692,747，其标题为“SMART ACTIVATION OF AN ENERGYDEVICE BY ANOTHER DEVICE”；
·美国临时专利申请62/692,748，其标题为“SMART ENERGY ARCHITECTURE”；以及
·美国临时专利申请号62/692,768，其标题为“SMART ENERGY DEVICES”。
本申请的申请人拥有于2018年6月29日提交的以下美国专利申请，这些专利申请中的每个的公开内容全文以引用方式并入本文：
·美国专利申请序列号16/024,090，其标题为“CAPACITIVE COUPLED RETURNPATH PAD WITH SEPARABLE ARRAY ELEMENTS”；
·美国专利申请序列号16/024,057，其标题为“CONTROLLING A SURGICALINSTRUMENT ACCORDING TO SENSED CLOSURE PARAMETERS”；
·美国专利申请序列号16/024,067，其标题为“SYSTEMS FOR ADJUSTING ENDEFFECTOR PARAMETERS BASED ON PERIOPERATIVE INFORMATION”；
·美国专利申请序列号16/024,075，其标题为“SAFETY SYSTEMS FOR SMARTPOWERED SURGICAL STAPLING”；
·美国专利申请序列号16/024,083，其标题为“SAFETY SYSTEMS FOR SMARTPOWERED SURGICAL STAPLING”；
·美国专利申请序列号16/024,094，其标题为“SURGICAL SYSTEMS FORDETECTING END EFFECTOR TISSUE DISTRIBUTION IRREGULARITIES”；
·美国专利申请序列号16/024,138，其标题为“SYSTEMS FOR DETECTINGPROXIMITY OF SURGICAL END EFFECTOR TO CANCEROUS TISSUE”；
·美国专利申请序列号16/024,150，其标题为“SURGICAL INSTRUMENT CARTRIDGESENSOR ASSEMBLIES”；
·美国专利申请序列号16/024,160，其标题为“VARIABLE OUTPUT CARTRIDGESENSOR ASSEMBLY”；
·美国专利申请序列号16/024,124，其标题为“SURGICAL INSTRUMENT HAVING AFLEXIBLE ELECTRODE”；
·美国专利申请序列号16/024,132，其标题为“SURGICAL INSTRUMENT HAVING AFLEXIBLE CIRCUIT”；
·美国专利申请序列号16/024,141，其标题为“SURGICAL INSTRUMENT WITH ATISSUE MARKING ASSEMBLY”；
·美国专利申请序列号16/024,162，其标题为“SURGICAL SYSTEMS WITHPRIORITIZED DATA TRANSMISSION CAPABILITIES”；
·美国专利申请序列号16/024,066，其标题为“SURGICAL EVACUATION SENSINGAND MOTOR CONTROL”；
·美国专利申请序列号16/024,096，其标题为“SURGICAL EVACUATION SENSORARRANGEMENTS”；
·美国专利申请序列号16/024,116，其标题为“SURGICAL EVACUATION FLOWPATHS”；
·美国专利申请序列号16/024,149，其标题为“SURGICAL EVACUATION SENSINGAND GENERATOR CONTROL”；
·美国专利申请序列号16/024,180，其标题为“SURGICAL EVACUATION SENSINGAND DISPLAY”；
·美国专利申请序列号16/024,245，其标题为“COMMUNICATION OF SMOKEEVACUATION SYSTEM PARAMETERS TO HUB OR CLOUD IN SMOKE EVACUATION MODULE FORINTERACTIVE SURGICAL PLATFORM”；
·美国专利申请序列号16/024,258，其标题为“SMOKE EVACUATION SYSTEMINCLUDING A SEGMENTED CONTROL CIRCUIT FOR INTERACTIVE SURGICAL PLATFORM”；
·美国专利申请序列号16/024,265，其标题为“SURGICAL EVACUATION SYSTEMWITH A COMMUNICATION CIRCUIT FOR COMMUNICATION BETWEEN A FILTER AND A SMOKEEVACUATION DEVICE”；以及
·美国专利申请序列号16/024,273，其标题为“DUAL IN-SERIES LARGE ANDSMALL DROPLET FILTERS”。
本申请的申请人拥有于2018年6月28日提交的以下美国临时专利申请，这些临时专利申请中的每个的公开内容全文以引用方式并入本文：
·美国临时专利申请序列号62/691,228，其标题为“A METHOD OF USINGreinforced FLEX CIRCUITS WITH MULTIPLE SENSORS WITH ELECTROSURGICAL DEVICES”；
·美国临时专利申请序列号62/691,227，其标题为“CONTROLLING A SURGICALinstrument ACCORDING TO SENSED CLOSURE PARAMETERS”；
·美国临时专利申请序列号62/691,230，其标题为“SURGICAL INSTRUMENTHAVING A FLEXIBLE ELECTRODE”；
·美国临时专利申请序列号62/691,219，其标题为“SURGICAL EVACUATIONSENSING AND MOTOR CONTROL”；
·美国临时专利申请序列号62/691,257，其标题为“COMMUNICATION OF SMOKEEVACUATION SYSTEM PARAMETERS TO HUB OR CLOUD IN SMOKE EVACUATION MODULE FORINTERACTIVE SURGICAL PLATFORM”；
·美国临时专利申请序列号62/691,262，其标题为“SURGICAL EVACUATIONSYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION BETWEEN A FILTER AND ASMOKE EVACUATION DEVICE”；以及
·美国临时专利申请序列号62/691,251，其标题为“DUAL IN-SERIES LARGE ANDSMALL DROPLET FILTERS”；
本申请的申请人拥有于2018年4月19日提交的以下美国临时专利申请，这些临时专利申请中的每个的公开内容全文以引用方式并入本文：
·美国临时专利申请序列号62/659,900，其标题为“METHOD OF HUBCOMMUNICATION”；
本申请的申请人拥有于2018年3月30日提交的以下美国临时专利申请，这些临时专利申请中的每个的公开内容全文以引用方式并入本文：
·2018年3月30日提交的美国临时专利申请号62/650,898，其标题为“CAPACITIVECOUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS”；
·美国临时专利申请序列号62/650,887，其标题为“SURGICAL SYSTEMS WITHOPTIMIZED SENSING CAPABILITIES”；
·美国专利申请序列号62/650,882，其标题为“SMOKE EVACUATION MODULE FORINTERACTIVE SURGICAL PLATFORM”；以及
·美国专利申请序列号62/650,877，其标题为“SURGICAL SMOKE EVACUATIONSENSING AND CONTROLS”。
本专利申请的申请人拥有于2018年3月29日提交的以下美国专利申请，这些临时专利申请中的每个的公开内容全文以引用方式并入本文：
·美国专利申请序列号15/940,641，其标题为“INTERACTIVE SURGICAL SYSTEMSWITH ENCRYPTED COMMUNICATION CAPABILITIES”；
·美国专利申请序列号15/940,648，其标题为“INTERACTIVE SURGICAL SYSTEMSWITH CONDITION HANDLING OF DEVICES AND DATA CAPABILITIES”；
·美国专利申请序列号15/940,656，其标题为“SURGICAL HUB COORDINATION OFCONTROL AND COMMUNICATION OF OPERATING ROOM DEVICES”；
·美国专利申请序列号15/940,666，其标题为“SPATIAL AWARENESS OF SURGICALHUBS IN OPERATING ROOMS”；
·美国专利申请序列号15/940,670，其标题为“COOPERATIVE UTILIZATION OFDATA DERIVED FROM SECONDARY SOURCES BY INTELLIGENT SURGICAL HUBS”；
·美国专利申请序列号15/940,677，其标题为“SURGICAL HUB CONTROLARRANGEMENTS”；
·美国专利申请序列号15/940,632，其标题为“DATA STRIPPING METHOD TOINTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD”；
·美国专利申请序列号15/940,640，其标题为“COMMUNICATION HUB AND STORAGEDEVICE FOR STORING PARAMETERS AND STATUS OF A SURGICAL DEVICE TO BE SHAREDWITH CLOUD BASED ANALYTICS SYSTEMS”；
·美国专利申请序列号15/940,645，其标题为“SELF DESCRIBING DATA PACKETSGENERATED AT AN ISSUING INSTRUMENT”；·美国专利申请序列号15/940,649，其标题为“DATA PAIRING TO INTERCONNECT A DEVICE MEASURED PARAMETER WITH AN OUTCOME”；
·美国专利申请序列号15/940,654，其标题为“SURGICAL HUB SITUATIONALAWARENESS”；
·美国专利申请序列号15/940,663，其标题为“SURGICAL SYSTEM DISTRIBUTEDPROCESSING”；
·美国专利申请序列号15/940,668，其标题为“AGGREGATION AND REPORTING OFSURGICAL HUB DATA”；
·美国专利申请序列号15/940,671，其标题为“SURGICAL HUB SPATIALAWARENESS TO DETERMINE DEVICES IN OPERATING THEATER”；
·美国专利申请序列号15/940,686，其标题为“DISPLAY OF ALIGNMENT OFSTAPLE CARTRIDGE TO PRIOR LINEAR STAPLE LINE”；
·美国专利申请序列号15/940,700，其标题为“STERILE FIELD INTERACTIVECONTROL DISPLAYS”；
·美国专利申请序列号15/940,629，其标题为“COMPUTER IMPLEMENTEDINTERACTIVE SURGICAL SYSTEMS”；
·美国专利申请序列号15/940,704，其标题为“USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTERED LIGHT”；
·美国专利申请序列号15/940,722，其标题为“CHARACTERIZATION OF TISSUEIRREGULARITIES THROUGH THE USE OF MONO-CHROMATIC LIGHT REFRACTIVITY”；以及
·美国专利申请序列号15/940,742，其标题为“DUAL CMOS ARRAY IMAGING”；
·美国专利申请序列号15/940,636，其标题为“ADAPTIVE CONTROL PROGRAMUPDATES FOR SURGICAL DEVICES”；
·美国专利申请序列号15/940,653，其标题为“ADAPTIVE CONTROL PROGRAMUPDATES FOR SURGICAL HUBS”；
·美国专利申请序列号15/940,660，其标题为“CLOUD-BASED MEDICAL ANALYTICSFOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER”；
·美国专利申请序列号15/940,679，其标题为“CLOUD-BASED MEDICAL ANALYTICSFOR LINKING OF LOCAL USAGE TRENDS WITH THE RESOURCE ACQUISITION BEHAVIORS OFLARGER DATA SET”；
·美国专利申请序列号15/940,694，其标题为“CLOUD-BASED MEDICAL ANALYTICSFOR MEDICAL FACILITY SEGMENTED INDIVIDUALIZATION OF INSTRUMENT FUNCTION”；
·美国专利申请序列号15/940,634，其标题为“CLOUD-BASED MEDICAL ANALYTICSFOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES”；
·美国专利申请序列号15/940,706，其标题为“DATA HANDLING ANDPRIORITIZATION IN A CLOUD ANALYTICS NETWORK”；以及
·美国专利申请序列号15/940,675，其标题为“CLOUD INTERFACE FOR COUPLEDSURGICAL DEVICES”；
·美国专利申请序列号15/940,627，其标题为“DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS”；
·美国专利申请序列号15/940,637，其标题为“COMMUNICATION ARRANGEMENTSFOR ROBOT-ASSISTED SURGICAL PLATFORMS”；
·美国专利申请序列号15/940,642，其标题为“CONTROLS FOR ROBOT-ASSISTEDSURGICAL PLATFORMS”；
·美国专利申请序列号15/940,676，其标题为“AUTOMATIC TOOL ADJUSTMENTSFOR ROBOT-ASSISTED SURGICAL PLATFORMS”；
·美国专利申请序列号15/940,680，其标题为“CONTROLLERS FOR ROBOT-ASSISTED SURGICAL PLATFORMS”；
·美国专利申请序列号15/940,683，其标题为“COOPERATIVE SURGICAL ACTIONSFOR ROBOT-ASSISTED SURGICAL PLATFORMS”；
·美国专利申请序列号15/940,690，其标题为“DISPLAY ARRANGEMENTS FORROBOT-ASSISTED SURGICAL PLATFORMS”；以及
·美国专利申请序列号15/940,711，其标题为“SENSING ARRANGEMENTS FORROBOT-ASSISTED SURGICAL PLATFORMS”。
本申请的申请人拥有于2018年3月28日提交的以下美国临时专利申请，这些临时专利申请中的每个的公开内容全文以引用方式并入本文：
·美国临时专利申请序列号62/649,302，其标题为“INTERACTIVE SURGICALSYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES”；
·美国临时专利申请序列号62/649,294，其标题为“DATA STRIPPING METHOD TOINTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD”；
·美国临时专利申请序列号62/649,300，其标题为“SURGICAL HUB SITUATIONALAWARENESS”；
·美国临时专利申请序列号62/649,309，其标题为“SURGICAL HUB SPATIALAWARENESS TO DETERMINE DEVICES IN OPERATING THEATER”；
·美国临时专利申请序列号62/649,310，其标题为“COMPUTER IMPLEMENTEDINTERACTIVE SURGICAL SYSTEMS”；
·美国临时专利申请序列号62/649,291，其标题为“USE OF LASER LIGHT ANDRED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTERED LIGHT”；
·美国临时专利申请序列号62/649,296，其标题为“ADAPTIVE CONTROL PROGRAMUPDATES FOR SURGICAL DEVICES”；
·美国临时专利申请序列号62/649,333，其标题为“CLOUD-BASED MEDICALANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER”；
·美国临时专利申请序列号62/649,327，其标题为“CLOUD-BASED MEDICALANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES”；
·美国临时专利申请序列号62/649,315，其标题为“DATA HANDLING ANDPRIORITIZATION IN A CLOUD ANALYTICS NETWORK”；
·美国临时专利申请序列号62/649,313，其标题为“CLOUD INTERFACE FORCOUPLED SURGICAL DEVICES”；
·美国临时专利申请序列号62/649,320，其标题为“DRIVE ARRANGEMENTS FORROBOT-ASSISTED SURGICAL PLATFORMS”；
·美国临时专利申请序列号62/649,307，其标题为“AUTOMATIC TOOLADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS”；以及
·美国临时专利申请序列号62/649,323，其标题为“SENSING ARRANGEMENTS FORROBOT-ASSISTED SURGICAL PLATFORMS”。
本申请的申请人拥有于2017年12月28日提交的以下美国临时专利申请，这些临时专利申请中的每个的公开内容全文以引用方式并入本文：
·美国临时专利申请序列号62/611,341，其标题为“INTERACTIVE SURGICALPLATFORM”；
·美国临时专利申请序列号62/611,340，其标题为“CLOUD-BASED MEDICALANALYTICS”；以及
·美国临时专利申请序列号62/611,339，其标题为“ROBOT ASSISTED SURGICALPLATFORM”；
在详细说明外科装置和发生器的各个方面之前，应该指出的是，示例性示例的应用或使用并不局限于附图和具体实施方式中所示出的部件的构造和布置的细节。示例性示例可单独实施，或与其他方面、变更形式和修改形式结合在一起实施，并可以各种方式实践或执行。此外，除非另外指明，否则本文所用的术语和表达是为了方便读者而对示例性实施例进行描述而所选的，并非为了限制性的目的。而且，应当理解，以下描述的方面中的一个或多个、方面和/或示例的表达可以与以下描述的其他方面、方面和/或示例的表达中的任何一个或多个组合。
各个方面涉及改进的超声外科装置、电外科装置和与其一起使用的发生器。超声外科装置的各方面可被配置用于例如在外科手术期间横切和/或凝固组织。电外科装置的各方面可被配置用于例如在外科手术期间横切、凝固、定标、焊接和/或干燥组织。
自适应超声刀控制算法
在各个方面，智能超声能量装置可包括用于控制超声刀的操作的自适应算法。在一个方面，超声刀自适应控制算法被配置成能够识别组织类型并调节装置参数。在一个方面，超声刀控制算法被配置成能够将组织类型参数化。本公开的以下区段描述了一种用于检测组织的胶原/弹性比以调谐超声刀的远侧末端的幅值的算法。本文结合例如图1至图2描述了智能超声能量装置的各个方面。因此，以下对自适应超声刀控制算法的描述应当结合图1至图2以及与其相关联的描述来阅读。
在某些外科手术中，期望采用自适应超声刀控制算法。在一个方面，可采用自适应超声刀控制算法来基于与超声刀接触的组织的类型来调节超声装置的参数。在一个方面，超声装置的参数可基于组织在超声端部执行器的钳口内的位置(例如，组织在夹持臂和超声刀之间的位置)来调节。超声换能器的阻抗可用于区分组织在端部执行器的远侧端部或近侧端部中的百分比。超声装置的反应可基于组织类型或组织的压缩率。在另一方面，超声装置的参数可基于所识别的组织类型或参数化来调节。例如，超声刀的远侧末端的机械位移幅值可基于在组织识别过程期间检测到的胶原与弹性蛋白组织的比而调谐。可使用多种技术检测胶原与弹性蛋白组织的比，包括红外(IR)表面反射率和比辐射率。由夹持臂和/或夹持臂的行程施加到组织的力以产生间隙和压缩。可采用横跨配备有电极的钳口的电连续性来确定被组织覆盖的钳口的百分比。
图1为根据本公开的至少一个方面的被配置成能够在包括模块化通信集线器的外科数据网络中执行自适应超声刀控制算法的系统800。在一个方面，发生器模块240被配置成能够执行如本文所述的自适应超声刀控制算法802。在另一方面，装置/器械235被配置成能够执行如本文参考图19至图33所述的自适应超声刀控制算法804。在另一方面，装置/器械235和装置/器械235两者被配置成能够执行如本文参考图19至图33所述的自适应超声刀控制算法802、804。
发生器模块240可包括经由功率变压器与非隔离级通信的患者隔离级。功率变压器的二次绕组包含在隔离级中，并且可包括分接配置(例如，中心分接或非中心分接配置)以限定驱动信号输出，该驱动信号输出用于将驱动信号递送到不同的外科器械，诸如例如超声外科器械、RF电外科器械和包括能够单独或同时递送的超声能量模式和RF能量模式的多功能外科器械。具体地，驱动信号输出可将超声驱动信号(例如，420V均方根(RMS)驱动信号)输出到超声外科器械241，并且驱动信号输出可将RF电外科驱动信号(例如，100V RMS驱动信号)输出到RF电外科器械241。本文参考图7至图12描述发生器模块240的各方面。
发生器模块240或装置/器械235或两者联接到模块化控制塔236，该模块化控制塔连接到多个手术室装置，诸如例如智能外科器械、机器人和位于手术室中的其他计算机化装置。在一些方面，外科数据网络可包括模块化通信集线器，该模块化通信集线器被配置成能够将位于医疗设施的一个或多个手术室中的模块化装置或专门配备用于外科操作的医疗设施中的任何房间连接到基于云的系统(例如，可包括联接到存储装置的远程服务器213的云204)。
位于手术室中的模块化装置可联接到模块化通信集线器。网络集线器和/或网络交换机可联接到网络路由器以将装置连接到云204或本地计算机系统。与装置相关联的数据可经由路由器传输到基于云的计算机以用于远程数据处理和操纵。与装置相关联的数据还可以被传输到本地计算机系统以用于本地数据处理和操纵。位于相同手术室中的模块化装置还可以联接到网络交换机。网络交换机可联接到网络集线器和/或网络路由器以将装置连接到云204。与装置相关联的数据可经由网络路由器传输到云204以用于数据处理和操纵。与装置相关联的数据还可以被传输到本地计算机系统以用于本地数据处理和操纵。
应当理解，云计算依赖于共享计算资源，而不是使用本地服务器或个人装置来处理软件应用程序。可使用“云”一词作为“因特网”的隐喻，尽管该术语不受此限制。因此，本文可使用术语“云计算”来指“基于因特网的计算的类型”，其中将不同的服务(诸如服务器、存储器和应用程序)递送到位于外科室(例如，固定、移动、临时或现场手术室或空间)中的模块化通信集线器和/或计算机系统以及通过因特网连接到模块化通信集线器和/或计算机系统的装置。云基础设施可由云服务提供方维护。在这种情况下，云服务提供方可为协调位于一个或多个手术室中的装置的使用和控制的实体。云计算服务可基于由智能外科器械、机器人和位于手术室中的其他计算机化装置所收集的数据来执行大量计算。集线器硬件使多个装置或连接能够连接到与云计算资源和存储器通信的计算机。
图1进一步示出了包括模块化通信集线器的计算机实现的交互式外科系统的一些方面，该模块化通信集线器可包括被配置成能够在外科数据网络中执行自适应超声刀控制算法的系统800。外科系统可包括与可包括远程服务器213的云204通信的至少一个外科集线器。在一个方面，计算机实现的交互式外科系统包括模块化控制塔236，该模块化控制塔连接到多个手术室装置，诸如例如智能外科器械、机器人和位于手术室中的其他计算机化装置。模块化控制塔236可包括联接到计算机系统的模块化通信集线器。在一些方面，模块化控制塔236联接到成像模块、发生器模块240、智能装置/器械235，该成像模块联接到内窥镜，该发生器模块联接到能量装置241，该智能装置/器械任选地联接到显示器237。手术室装置经由模块化控制塔236联接到云计算资源和数据存储。机器人集线器222也可连接到模块化控制塔236和云计算资源。装置/器械235、可视化系统208等等可经由有线或无线通信标准或协议联接到模块化控制塔236，如本文所述。模块化控制塔236可联接到集线器显示器215(例如，监测器、屏幕)以显示和叠加从成像模块、装置/器械显示器和/或其他可视化系统208接收的图像。集线器显示器215还可结合图像和叠加图像来显示从连接到模块化控制塔的装置接收的数据。
发生器硬件
图2示出了发生器900的示例，该示例为发生器的一种形式，该发生器被配置成能够联接到超声器械并且还被配置成能够在包括模块化通信集线器的外科数据网络中执行自适应超声刀控制算法，如图1中所示。发生器900被配置成能够将多个能量模态递送到外科器械。发生器900提供用于独立地或同时将能量递送到外科器械的RF信号和超声信号。RF信号和超声信号可单独或组合提供，并且可同时提供。如上所述，至少一个发生器输出端可通过单个端口递送多种能量模态(例如，超声、双极或单极RF、不可逆和/或可逆电穿孔和/或微波能量等等)，并且这些信号可分开或同时被递送到端部执行器以处理组织。发生器900包括联接到波形发生器904的处理器902。处理器902和波形发生器904被配置成能够基于存储在联接到处理器902的存储器中的信息来生成多种信号波形，为了本公开清楚起见而未示出该存储器。与波形相关联的数字信息被提供给波形发生器904，该波形发生器包括一个或多个DAC电路以将数字输入转换成模拟输出。模拟输出被馈送到放大器906以用于信号调节和放大。放大器906的经调节和放大的输出联接到功率变压器908。信号通过功率变压器908联接到患者隔离侧中的次级侧。第一能量模态的第一信号被提供给被标记为ENERGY1和RETURN的端子之间的外科器械。第二能量模态的第二信号联接到电容器910两端并被提供给被标记为ENERGY2和RETURN的端子之间的外科器械。应当理解，可输出超过两种能量模态，并且因此下标“n”可被用来指定可提供多达n个ENERGYn端子，其中n是大于1的正整数。还应当理解，在不脱离本公开的范围的情况下，可提供多达n个返回路径RETURNn。
第一电压感测电路912联接到被标记为ENERGY1和RETURN路径的端子的两端，以测量其间的输出电压。第二电压感测电路924联接到被标记为ENERGY2和RETURN路径的端子的两端，以测量其间的输出电压。如图所示，电流感测电路914与功率变压器908的次级侧的RETURN支路串联设置，以测量任一能量模态的输出电流。如果为每种能量模态提供不同的返回路径，则应在每个返回支路中提供单独的电流感测电路。第一电压感测电路912和第二电压感测电路924的输出被提供给相应的隔离变压器916、922，并且电流感测电路914的输出被提供给另一隔离变压器918。功率变压器908(非患者隔离侧)的初级侧上的隔离变压器916、928、922的输出被提供给一个或多个ADC电路926。ADC电路926的数字化输出被提供给处理器902用于进一步处理和计算。可采用输出电压和输出电流反馈信息来调节提供给外科器械的输出电压和电流，并且计算输出阻抗等参数。处理器902和患者隔离电路之间的输入/输出通信通过接口电路920提供。传感器也可通过接口电路920与处理器902电通信。
在一个方面，阻抗可由处理器902通过将联接在被标记为ENERGY1/RETURN的端子两端的第一电压感测电路912或联接在被标记为ENERGY2/RETURN的端子两端的第二电压感测电路924的输出除以与功率变压器908的次级侧的RETURN支路串联设置的电流感测电路914的输出来确定。第一电压感测电路912和第二电压感测电路924的输出被提供给单独的隔离变压器916、922，并且电流感测电路914的输出被提供给另一隔离变压器916。来自ADC电路926的数字化电压和电流感测测量值被提供给处理器902以用于计算阻抗。例如，第一能量模态ENERGY1可为超声能量，并且第二能量模态ENERGY2可为RF能量。然而，除了超声和双极或单极RF能量模态之外，其他能量模态还包括不可逆和/或可逆电穿孔和/或微波能量等。此外，尽管图2中所示的示例示出了可为两种或更多种能量模态提供单个返回路径RETURN，但在其他方面，可为每种能量模态ENERGYn提供多个返回路径RETURNn。因此，如本文所述，超声换能器阻抗可通过将第一电压感测电路912的输出除以电流感测电路914的输出来测量，并且组织阻抗可通过将第二电压感测电路924的输出除以电流感测电路914的输出来测量。
如图2中所示，包括至少一个输出端口的发生器900可包括具有单个输出端和多个分接头的功率变压器908，以例如根据正在执行的组织处理类型以一种或多种能量模态(诸如超声、双极或单极RF、不可逆和/或可逆电穿孔和/或微波能量等等)的形式向端部执行器提供功率。例如，发生器900可用更高电压和更低电流递送能量以驱动超声换能器，用更低电压和更高电流递送能量以驱动RF电极以用于密封组织，或者用凝固波形递送能量以用于使用单极或双极RF电外科电极进行斑点凝结。来自发生器900的输出波形可被操纵、切换或滤波，以向外科器械的端部执行器提供频率。超声换能器与发生器900输出端的连接将优选地位于被标记为ENERGY1和RETURN的输出端之间，如图2中所示。在一个示例中，RF双极电极与发生器900输出端的连接将优选地位于被标记为ENERGY2和RETURN的输出端之间。在单极输出的情况下，优选的连接将是有源电极(例如，光锥(pencil)或其他探头)到ENERGY2输出端的和连接至RETURN输出端的合适的返回垫。
附加细节公开于2017年3月30日公布的标题为“TECHNIQUES FOR OPERATINGGENERATOR FOR DIGITALLY GENERATING ELECTRICAL SIGNAL WAVEFORMS AND SURGICALINSTRUMENTS”的美国专利申请公布2017/0086914中，该专利申请全文以引用方式并入本文。
如本说明书通篇所用，术语“无线”及其衍生物可用于描述可通过使用经调制的电磁辐射通过非固体介质来传送数据的电路、装置、系统、方法、技术、通信信道等。该术语并不意味着相关联的装置不包含任何电线，尽管在一些方面它们可能不包含。通信模块可实现多种无线或有线通信标准或协议中的任一种，包括但不限于Wi-Fi(IEEE 802.11系列)、WiMAX(IEEE 802.16系列)、IEEE 802.20、长期演进(LTE)、Ev-DO、HSPA+、HSDPA+、HSUPA+、EDGE、GSM、GPRS、CDMA、TDMA、DECT、蓝牙、及其以太网衍生物、以及被指定为3G、4G、5G和以上的任何其他无线和有线协议。计算模块可包括多个通信模块。例如，第一通信模块可专用于更短距离的无线通信诸如Wi-Fi和蓝牙，并且第二通信模块可专用于更长距离的无线通信诸如GPS、EDGE、GPRS、CDMA、WiMAX、LTE、Ev-DO等。
如本文所用，处理器或处理单元是对一些外部数据源(通常为存储器或一些其他数据流)执行操作的电子电路。本文所用术语是指组合多个专门的“处理器”的一个或多个系统(尤其是片上系统(SoC))中的中央处理器(中央处理单元)。
如本文所用，片上系统或芯片上系统(SoC或SOC)为集成了计算机或其他电子系统的所有部件的集成电路(也被称为“IC”或“芯片”)。它可包含数字、模拟、混合信号以及通常射频功能—全部在单个基板上。SoC将微控制器(或微处理器)与高级外围装置如图形处理单元(GPU)、Wi-Fi模块或协处理器集成。SoC可包含或可不包含内置存储器。
如本文所用，微控制器或控制器为将微处理器与外围电路和存储器集成的系统。微控制器(或微控制器单元的MCU)可被实现为单个集成电路上的小型计算机。其可类似于SoC；SoC可包括作为其部件之一的微控制器。微控制器可包含一个或多个核心处理单元(CPU)以及存储器和可编程输入/输出外围装置。以铁电RAM、NOR闪存或OTP ROM形式的程序存储器以及少量RAM也经常包括在芯片上。与个人计算机或由各种分立芯片组成的其他通用应用中使用的微处理器相比，微控制器可用于嵌入式应用。
如本文所用，术语控制器或微控制器可为与外围装置交接的独立式IC或芯片装置。这可为计算机的两个部件或用于管理该装置的操作(以及与该装置的连接)的外部装置上的控制器之间的链路。
如本文所述的处理器或微控制器中的任一者可为任何单核或多核处理器，诸如由Texas Instruments提供的商品名为ARM Cortex的那些。在一个方面，处理器可为例如购自Texas Instruments的LM4F230H5QR ARM Cortex-M4F处理器内核，其包括：256KB的单循环闪存或其他非易失性存储器(高达40MHz)的片上存储器、用于使性能改善高于40MHz的预取缓冲器、32KB的单循环串行随机存取存储器(SRAM)、装载有
Figure BDA0002671339460000291
软件的内部只读存储器(ROM)、2KB的电可擦除可编程只读存储器(EEPROM)、一个或多个脉宽调制(PWM)模块、一个或多个正交编码器输入(QEI)模拟、具有12个模拟输入信道的一个或多个12位模数转换器(ADC)、以及易得的其他特征。
在一个示例中，处理器可包括安全控制器，该安全控制器包括两个基于控制器的系列，诸如同样由Texas Instruments提供的商品名为Hercules ARM Cortex R4的TMS570和RM4x。安全控制器可被配置专门用于IEC61508和ISO 26262安全关键应用等等，以提供高级集成安全特征部，同时递送可定标的性能、连接性和存储器选项。
模块化装置包括可接纳在外科集线器内的模块(例如，如结合图3所述)和外科装置或器械，该外科装置或器械可连接到各种模块以便与对应的外科集线器连接或配对。模块化装置包括例如智能外科器械、医学成像装置、抽吸/冲洗装置、排烟器、能量发生器、呼吸机、吹入器和显示器。本文所述的模块化装置可通过控制算法来控制。控制算法可在模块化装置自身上、在与特定模块化装置配对的外科集线器上或在模块化装置和外科集线器两者上执行(例如，经由分布式计算架构)。在一些示例中，模块化装置的控制算法基于由模块化装置自身感测到的数据来控制装置(即，通过模块化装置之中、之上或连接到模块化装置的传感器)。该数据可与正在手术的患者(例如，组织特性或吹入压力)或模块化装置本身相关(例如，刀被推进的速率、马达电流或能量水平)。例如，外科缝合和切割器械的控制算法可根据刀在其前进时遇到的阻力来控制器械的马达驱动其刀穿过组织的速率。
图3示出了包括发生器1100和可与其一起使用的各种外科器械1104、1106、1108的外科系统1000的一种形式，其中外科器械1104为超声外科器械，外科器械1106为RF电外科器械，并且多功能外科器械1108为超声/RF电外科器械的组合。发生器1100可配置用于与多种外科装置一起使用。根据各种形式，发生器1100可为可配置用于与不同类型的不同外科器械一起使用，该外科器械包括例如超声外科器械1104、RF电外科器械1106以及集成了从发生器1100同时递送的RF能量和超声能量的多功能外科器械1108。尽管在图3的形式中，发生器1100被示出为独立于外科器械1104、1106、1108，但在一种形式中，发生器1100可与外科器械1104、1106、1108中的任一者整体地形成，以形成一体式外科系统。发生器1100包括位于发生器1100控制台的前面板上的输入装置1110。输入装置1110可包括生成适用于对发生器1100的操作进行编程的信号的任何合适的装置。发生器1100可被配置用于有线或无线通信。
发生器1100被配置成能够驱动多个外科器械1104、1106、1108。第一外科器械为超声外科器械1104并且包括手持件1105(HP)、超声换能器1120、轴1126和端部执行器1122。端部执行器1122包括声学地联接到超声换能器1120的超声刀1128和夹持臂1140。手持件1105包括用于操作夹持臂1140的触发器1143和用于给超声刀1128供能和驱动超声刀1128或其他功能的切换按钮1134a、1134b、1134c的组合。切换按钮1134a、1134b、1134c可以被配置成能够用发生器1100给超声换能器1120供能。
发生器1100还被配置成能够驱动第二外科器械1106。第二外科器械1106为RF电外科器械，并且包括手持件1107(HP)、轴1127和端部执行器1124。端部执行器1124包括夹持臂1142a、1142b中的电极并穿过轴1127的电导体部分返回。这些电极联接到发生器1100内的双极能量源并由其供能。手持件1107包括用于操作夹持臂1142a、1142b的触发器1145和用于致动能量开关以给端部执行器1124中的电极供能的能量按钮1135。
发生器1100还被配置成能够驱动多功能外科器械1108。多功能外科器械1108包括手持件1109(HP)、轴1129和端部执行器1125。端部执行器1125包括超声刀1149和夹持臂1146。超声刀1149声学地联接到超声换能器1120。手持件1109包括用于操作夹持臂1146的触发器1147和用于给超声刀1149供能和驱动超声刀1149或其他功能的切换按钮1137a、1137b、1137c的组合。切换按钮1137a、1137b、1137c可以被配置成能够用发生器1100给超声换能器1120供能，并且用同样包含在发生器1100内的双极能量源给超声刀1149供能。
发生器1100可配置用于与多种外科装置一起使用。根据各种形式，发生器1100可为可配置用于与不同类型的不同外科器械一起使用，该外科器械包括例如超声外科器械1104、RF电外科器械1106和集成了从发生器1100同时递送的RF能量和超声能量的多功能外科器械1108。尽管在图3的形式中，发生器1100被示出为独立于外科器械1104、1106、1108，但在另一种形式中，发生器1100可与外科器械1104、1106、1108中的任一者整体地形成，以形成一体式外科系统。如上文所讨论的，发生器1100包括位于发生器1100控制台的前面板上的输入装置1110。输入装置1110可包括生成适用于对发生器1100的操作进行编程的信号的任何合适的装置。发生器1100还可包括一个或多个输出装置1112。用于数字生成电信号波形的发生器和外科器械的另外方面描述于美国专利公布US-2017-0086914-A1中，该专利全文以引用方式并入本文。
图4为根据本公开的至少一个方面的示例性超声装置1104的端部执行器1122。端部执行器1122可包括刀1128，该刀可经由波导联接到超声换能器1120。当由超声换能器1120驱动时，刀1128可振动，并且当与组织进行接触时，可切割和/或凝固组织，如本文所述。根据各个方面，并且如图4中所示，端部执行器1122还可包括夹持臂1140，该夹持臂可被配置用于与端部执行器1122的刀1128协同动作。利用刀1128，夹持臂1140可包括一组钳口。夹持臂1140可以可枢转地连接在器械部分1104的轴1126的远侧端部处。夹持臂1140可包括夹持臂组织垫1163，该夹持臂组织垫1163可由
Figure BDA0002671339460000311
或其他合适的低摩擦材料形成。可安装垫1163，以用于与刀1128协作，其中夹持臂1140的枢转运动将夹持垫1163定位成与刀1128大体平行并接触。通过该构造，待夹持的组织咬合可被抓握在组织垫1163和刀1128之间。组织垫1163可具有锯齿状配置，包括多个轴向间隔开的朝近侧延伸的抓持齿1161，以与刀1128协作增强对组织的抓持。夹持臂1140可从图4中所示的打开位置以任何合适的方式转变到闭合位置(其中夹持臂1140与刀1128接触或与该刀接近)。例如，手持件1105可包括钳口闭合触发器。当由临床医生致动时，钳口闭合触发器可以任何合适的方式枢转夹持臂1140。
发生器1100可被激活以按照任何合适的方式将驱动信号提供到超声换能器1120。例如，发生器1100可包括脚踏开关1430(图5)，该脚踏开关经由脚踏开关缆线1432联接到发生器1100。临床医生可通过压下脚踏开关1430来激活超声换能器1120，并且从而激活超声换能器1120和刀1128。此外，或作为脚踏开关1430的替代，装置1104的一些方面可利用定位于手持件1105上的一个或多个开关，当被激活时，该一个或多个开关可使发生器1100激活超声换能器1120。在一个方面，例如，一个或多个开关可包括一对切换按钮1134、1134a、1134b(图3)例如以确定装置1104的操作模式。当切换按钮1134a被压下时，例如，超声发生器1100可将最大驱动信号提供到超声换能器1120，从而使其产生最大超声能量输出。压下切换按钮1134b可使超声发生器1100将用户可选的驱动信号提供到超声换能器1120，从而使其产生小于最大值的超声能量输出。附加地或另选地，装置1104可包括第二开关以例如指示用于经由端部执行器1122的夹持臂1140操作钳口的钳口闭合触发器的位置。此外，在一些方面，超声发生器1100可基于钳口闭合触发器的位置被激活(例如，当临床医生压下钳口闭合触发器以经由夹持臂1140闭合钳口时，可施加超声能量)。
附加地或另选地，一个或多个开关可包括切换按钮1134，该切换按钮在被压下时使发生器1100提供脉冲输出(图3)。脉冲例如可按任何合适的频率和分组提供。在某些方面，例如，脉冲的功率水平可为与切换按钮1134a、1134b相关联的功率水平(最大值、小于最大值)。
应当理解，装置1104可包括切换按钮1134a、1134b、1134的任何组合(图3)。例如，装置1104可被配置成能够仅具有两个切换按钮：用于产生最大超声能量输出的切换按钮1134a和用于以最大功率水平或小于最大功率水平产生脉冲输出的切换按钮1134。这样，发生器1100的驱动信号输出配置可为五个连续信号，或任何离散数量的单个脉冲信号(1、2、3、4或5)。在某些方面，例如可基于发生器1100中的EEPROM设定和/或一个或多个用户功率水平选择来控制特定的驱动信号配置。
在某些方面，可提供双位开关来替代切换按钮1134(图3)。例如，装置1104可包括用于以最大功率水平产生连续输出的切换按钮1134a和双位切换按钮1134b。在第一止动位置中，切换按钮1134b可以小于最大功率水平产生连续输出，并且在第二止动位置中，切换按钮1134b可产生脉冲输出(例如，根据EEPROM设置，以最大功率水平或小于最大功率水平)。
在一些方面，RF电外科端部执行器1124、1125(图3)还可包括一对电极。电极可例如经由缆线与发生器1100通信。电极可用于例如测量存在于夹持臂1142a、1146和刀1142b、1149之间的组织咬合的阻抗。发生器1100可向电极提供信号(例如，非治疗信号)。例如，可通过监测信号的电流、电压等来发现组织咬合的阻抗。
在各个方面，发生器1100可包括若干独立的功能元件，诸如模块和/或块，如图5中、图3的外科系统1000的图示中所示。不同的功能元件或模块可被配置用于驱动不同种类的外科装置1104、1106、1108。例如，超声发生器模块可驱动超声装置，诸如超声外科装置1104。电外科/RF发生器模块可驱动电外科装置1106。例如，模块可生成用于驱动外科装置1104、1106、1108的相应的驱动信号。在各个方面，超声发生器模块和/或电外科/RF发生器模块各自可与发生器1100整体地形成。另选地，模块中的一个或多个模块可被设置成电联接到发生器1100的单独的电路模块。(模块以虚线显示以示出该部分。)此外，在一些方面，电外科/RF发生器模块可与超声发生器模块整体地形成，或反之亦然。
根据所述方面，超声发生器模块可生成特定电压、电流和频率(例如，55,500循环每秒或Hz)的一个或多个驱动信号。该一个或多个驱动信号可被提供至超声装置1104、尤其是可例如如上所述进行操作的换能器1120。在一个方面，发生器1100可被配置成能够生成特定电压、电流和/或频率输出信号的驱动信号，该驱动信号可在高分辨率、精度和再现性方面进行修改。
根据所述方面，电外科/RF发生器模块可生成具有足以使用射频(RF)能量执行双极电外科的输出功率的一个或多个驱动信号。在双极电外科应用中，驱动信号可被提供至例如电外科装置1106的电极，如上文所述。因此，发生器1100可被配置用于通过将足以处理组织(例如，凝固、烧灼、组织焊接等)的电能施加到组织而达到治疗目的。
发生器1100可包括位于例如发生器1100控制台的前面板上的输入装置2150(图8B)。输入装置2150可包括产生适用于对发生器1100的操作进行编程的信号的任何合适的装置。在操作中，用户可以使用输入装置2150对发生器1100的操作进行编程或以其他方式进行控制。输入装置2150可包括生成可由发生器(例如，由包含在发生器中的一个或多个处理器)用来控制发生器1100的操作(例如，超声发生器模块和/或电外科/RF发生器模块的操作)的信号的任何合适的装置。在各个方面，输入装置2150包括以下中的一种或多种：按钮、开关、指轮、键盘、小键盘、触摸屏监测器、指点装置、到通用或专用计算机的远程连接。在其他方面，输入装置2150例如可包括合适的用户界面，诸如显示于触摸屏监测器上的一个或多个用户界面屏幕，例如。因此，通过输入装置2150，用户可设定发生器的各种操作参数或对其进行编程，诸如例如由超声发生器模块和/或电外科/RF发生器模块生成的一个或多个驱动信号的电流(I)、电压(V)、频率(f)和/或周期(T)。
发生器1100还可包括位于例如发生器1100控制台的前面板上的输出装置2140(图8B)。输出装置2140包括用于向用户提供感观反馈的一个或多个装置。此类装置可包括例如视觉反馈装置(例如，LCD显示屏、LED指示器)、音频反馈装置(例如，扬声器、蜂鸣器)或触觉反馈装置(例如，触觉致动器)。
尽管可通过示例来描述发生器1100的某些模块和/或块，但可理解，可使用更多或更少数目的模块和/或块，并仍落入所述方面的范围内。此外，虽然各个方面可按照模块和/或块的形式描述以便于说明，但此类模块和/或块可通过一个或多个硬件部件(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)和/或软件部件(例如，程序、子例程、逻辑)、和/或硬件部件与软件部件的组合加以实施。
在一个方面，超声发生器驱动模块和电外科/RF驱动模块1110(图3)可包括实现为固件、软件、硬件或它们的任何组合的一个或多个嵌入式应用程序。模块可包括各种可执行模块，诸如软件、程序、数据、驱动器、应用程序接口(API)等。固件可存储在非易失性存储器(NVM)(诸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中可保护闪存存储器。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)(诸如动态RAM(DRAM)、双数据率DRAM(DDRAM)和/或同步DRAM(SDRAM))。
在一个方面，模块包括硬件部件，该硬件部件被实现为用于执行程序指令的处理器，该程序指令用于监测装置1104、1106、1108的各种可测量特征并生成用于操作装置1104、1106、1108的对应输出驱动信号。在其中发生器1100与装置1104结合使用的方面中，驱动信号可以切割和/或凝固操作模式驱动超声换能器1120。可测量装置1104和/或组织的电特征并且将其用于控制发生器1100的操作方面并且/或者可作为反馈提供给用户。在其中发生器1100与装置1106结合使用的方面中，驱动信号可以切割、凝固和/或脱水模式将电能(例如，RF能量)供应至端部执行器1124。可测量装置1106和/或组织的电特征并将其用于控制发生器1100的操作方面并且/或者可作为反馈向用户提供。在各个方面，如在前文所述，硬件部件可被实现为DSP、PLD、ASIC、电路和/或寄存器。在一个方面，处理器可被配置成能够存储和执行计算机软件程序指令，以生成用于驱动装置1104、1106、1108的各种部件(例如超声换能器1120和端部执行器1122、1124、1125)的阶跃函数输出信号。
机电超声系统包括超声换能器、波导和超声刀。机电超声系统具有由超声换能器、波导和超声刀的物理特性限定的初始谐振频率。超声换能器受激于交变电压Vg(t)信号和电流Ig(t)信号的谐振频率等于所述机电超声系统。当机电超声系统处于谐振时，电压Vg(t)信号和电流Ig(t)信号之间的相位差为零。换句话说，在谐振时，感应阻抗等于电容阻抗。当超声刀加热时，超声刀(被建模为等效电容)的顺应性导致机电超声系统的谐振频率偏移。因此，感应阻抗不再等于电容阻抗，从而导致机电超声系统的驱动频率和谐振频率之间不匹配。系统现在运行“非谐振(off-resonance)”。驱动频率和谐振频率之间的失配的表现为施加到超声换能器的电压Vg(t)信号和电流Ig(t)信号之间的相位差。发生器电子器件可以容易地监测电压Vg(t)和电流Ig(t)信号之间的相位差并且可以连续调节驱动频率直到相位差再次为零为止。此时，新驱动频率等于机电超声系统的新谐振频率。相位和/或频率的变化可用作超声刀温度的间接测量值。
如图6中所示，超声换能器的机电特性可被建模成等效电路，该等效电路包括具有静态电容的第一支路和具有限定谐振器的机电特性的串联连接的电感、电阻和电容的第二“动态”支路。已知的超声发生器可包括调谐电感器，该调谐电感器用于解谐处于谐振频率的静态电容，使得大体上发生器的驱动信号电流中的所有均流入动态支路中。因此，通过使用调谐电感器，发生器的驱动信号电流表示动态支路电流，并且因此发生器能够控制其驱动信号以保持超声换能器的谐振频率。调谐电感器还可变换超声换能器的相位阻抗曲线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在操作谐振频率下的特定静态电容匹配。换句话讲，具有不同静态电容的不同超声换能器需要不同的调谐电感器。
图6示出了根据一个方面的超声换能器诸如超声换能器1120的等效电路1500。电路1500包括具有限定谐振器的机电特性的串联连接的电感Ls、电阻Rs和电容Cs的第一“动态”支路和具有静态电容的第二电容支路C0。可在驱动电压Vg(t)下从发生器接收驱动电流Ig(t)，其中动态电流Im(t)流过第一支路并且电流Ig(t)-Im(t)流过电容支路。可通过适当地控制Ig(t)和Vg(t)来实现对超声换能器的机电特性的控制。如上所述，已知的发生器架构可包括并联谐振电路中的调谐电感器Lt(在图6中以虚线示出)，该调谐电感器用于将静态电容C0调谐成谐振频率，使得大体上发生器的电流输出Ig(t)中的所有均流过动态支路。以此方式，通过控制发生器电流输出Ig(t)来实现对动态支路电流Im(t)的控制。然而，调谐电感器Lt对超声换能器的静态电容C0是特定的，并且具有不同静态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在单个谐振频率下与静态电容C0的标称值匹配，所以仅在该频率下确保对动态支路电流Im(t)的精确控制。随着频率随换能器温度的推移而向下偏移，对动态支路电流的精确控制受到损害。
发生器1100的各个方面可不依赖于调谐电感器Lt来监测动态支路电流Im(t)。相反，发生器1100可使用在施加用于特定超声外科装置1104的功率之间静电容C0的测量值(连同驱动信号电压和电流反馈数据)，以在动态行进的基础上(例如，实时地)确定动态支路电流Im(t)的值。因此，发生器1100的此类方面能够提供虚拟调谐，以模拟被调谐的系统或与在任何频率下的静电容C0的任何值谐振，而非仅在静态电容C0的标称值所指示的单个谐振频率下谐振。
图7为发生器1100的一个方面的简化框图，该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。图8A至图8C示出了根据一个方面的图7的发生器1100的架构。参考图7，发生器1100可包括患者隔离级1520，该患者隔离级经由功率变压器1560与非隔离级1540通信。功率变压器1560的二次绕组1580包含在隔离级1520中，并且可包括分接配置(例如，中心分接或非中心分接配置)来限定驱动信号输出1600a、1600b、1600c，以用于将驱动信号输出至不同外科装置(诸如例如，超声外科装置1104和电外科装置1106)。具体而言，驱动信号输出1600a、1600b、1600c可将驱动信号(例如，420V RMS驱动信号)输出至超声外科装置1104，并且驱动信号输出1600a、1600b、1600c可将驱动信号(例如，100V RMS驱动信号)输出至电外科装置1106，其中输出1600b对应于功率变压器1560的中心分接头。非隔离级1540可包括功率放大器1620，该功率放大器具有连接到功率变压器1560的一次绕组1640的输出。在某些方面，功率放大器1620可包括例如推拉放大器。非隔离级1540还可包括可编程逻辑装置1660，该可编程逻辑装置用于向数模转换器(DAC)1680供应数字输出，而该数模转换器1680继而将对应的模拟信号供应至功率放大器1620的输入端。在某些方面，可编程逻辑装置1660可包括例如现场可编程门阵列(FPGA)。由于经由DAC 1680控制功率放大器1620的输入端，可编程逻辑装置1660可因此控制在驱动信号输出1600a、1600b、1600c处出现的驱动信号的多个参数(例如，频率、波形形状、波形幅值)中的任一者。在某些方面并且如下所述，可编程逻辑装置1660结合处理器(例如，以下所述的处理器1740)可实现多个基于数字信号处理(DSP)的算法和/或其他控制算法，以控制由发生器1100输出的驱动信号的参数。
可通过开关模式调整器1700将功率供应至功率放大器1620的功率轨。在某些方面，开关模式调节器1700可包括例如可调式降压调节器。如上所述，非隔离级1540还可包括处理器1740，该处理器在一个方面可包括DSP处理器诸如ADSP-21469SHARC DSP，其可得自例如Analog Devices,Norwood,Mass.。在某些方面，处理器1740可响应于由处理器1740经由模数转换器(ADC)1760从功率放大器1620接收的电压反馈数据来控制开关模式功率转换器1700的操作。在一个方面，例如，处理器1740可经由ADC 1760接收正被功率放大器1620放大的信号(例如，RF信号)的波形包络作为输入。然后，处理器1740可控制开关模式调节器1700(例如，经由脉宽调制(PWM)输出)，使得被供应至功率放大器1620的干线电压跟踪经放大信号的波形包络。通过基于波形包络动态调制功率放大器1620的干线电压，功率放大器1620的效率相对于固定干线电压放大器方案可显著升高。处理器1740可被配置用于有线或无线通信。
在某些方面并且如结合图9A至图9B更详细地讨论的，可编程逻辑装置1660结合处理器1740可实现直接数字合成器(DDS)控制方案，以控制由发生器1100输出的驱动信号的波形形状、频率和/或幅值。在一个方面，例如，可编程逻辑装置1660可通过检索(recall)存储在动态更新的查找表(LUT)(诸如可嵌入在FPGA中的RAM LUT)中的波形样本来实现DDS控制算法2680(图9A)。该控制算法尤其可用于如下超声应用，其中超声换能器诸如超声换能器1120可由其谐振频率下的纯正弦式电流驱动。因为其他频率可激发寄生谐振，因此最小化或减小动态支路电流的总失真可相应地最小化或减小不利的谐振效应。因为由发生器1100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1560、功率放大器1620)中存在的各种失真源的影响，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(诸如由处理器1740实现的误差控制算法)中，该算法通过适当地在动态行进的基础上(例如，实时地)使存储于LUT中的波形样本预先失真或修改来补偿失真。在一种形式中，对LUT样本所施加的预先失真量或程度可基于所计算的动态支路电流和期望的电流波形形状之间的误差而定，其中该误差可在逐一样本的基础上确定。以该方式，预先失真的LUT样本在通过驱动电路进行处理时，可使动态支路驱动信号具有所期望的波形形状(例如，正弦形状)，以最佳地驱动超声换能器。因此，在此类方面，当考虑到失真效应时，LUT波形样本将因此不表示驱动信号的期望波形形状，而是表示最终产生动态支路驱动信号的期望波形形状所期望的波形形状。
非隔离级1540还可包括ADC 1780和ADC 1800，该ADC 1780和ADC 1800经由相应的隔离变压器1820、1840联接到功率变压器1560的输出，以分别用于对由发生器1100输出的驱动信号的电压和电流进行采样。在某些方面，ADC 1780、1800可被配置成能够以高速(例如，80Msps)进行采样，以启用对驱动信号的过采样。在一个方面，例如，ADC 1780、1800的采样速度可启用驱动信号的约200X(根据频率而定)的过采样。在某些方面，可通过经由二路式多路复用器接收输入电压信号和电流信号的单个ADC来执行ADC 1780、1800的采样操作。通过在发生器1100的方面中使用高速采样，除可实现其他事物之外，还可启用对流过动态支路的复杂电流的计算(这在某些方面可用于实现上述基于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。ADC 1780、1800所输出的电压和电流反馈数据可由可编程逻辑装置1660接收并处理(例如，FIFO缓冲、多路复用)并且被存储于数据存储器中，以供例如DSP处理器1740后续检索。如上所述，电压和电流反馈数据可用作算法的输入用于以动态行进方式使LUT波形样本预先失真或修改。在某些方面，当采集到电压和电流反馈数据对时，这可需要基于由可编程逻辑装置1660输出的对应LUT样本或以其他方式与对应LUT样本相关联，为每个所存储的电压和电流反馈数据对进行编索引。以此方式使LUT样本和电压和电流反馈数据同步有助于预失真算法的准确计时和稳定性。
在某些方面，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)。在一个方面，例如，可使用电压和电流反馈数据来确定阻抗相位，例如电压和电流驱动信号之间的相位差。然后，可控制驱动信号的频率以最小化或减小所确定阻抗相位和阻抗相位设定点(例如，0°)之间的差值，从而最小化或减小谐波失真的影响，并且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处理器1740中实现，例如，其中频率控制信号作为输入被供应至由可编程逻辑装置1660实现的DDS控制算法。
阻抗相位可通过傅立叶分析来确定。在一个方面，可使用如下的快速傅里叶变换(FFT)或离散傅里叶变换(DFT)来确定发生器电压Vg(t)驱动信号和发生器电流Ig(t)驱动信号之间的相位差：
Figure BDA0002671339460000391
Figure BDA0002671339460000392
Figure BDA0002671339460000393
Figure BDA0002671339460000394
在正弦频率下评估傅立叶变换得到：
Figure BDA0002671339460000401
Figure BDA0002671339460000402
其他方法包括加权最小二乘评估、卡尔曼滤波和基于空间矢量的技术。例如，FFT或DFT技术中的几乎所有处理可在数字域中在例如2-信道高速ADC 1780、1800的辅助下执行。在一种技术中，电压信号和电流信号的数字信号样本是用FFT或DFT傅里叶变换的。可通过以下方程计算任何时间点处的相位角
Figure BDA0002671339460000403
Figure BDA0002671339460000404
其中
Figure BDA0002671339460000405
为相位角，f为频率，t为时间，并且
Figure BDA0002671339460000406
为在t＝0处的相位。
用于确定电压Vg(t)信号和电流Ig(t)信号之间的相位差的另一技术为零点交叉方法并且产生非常精确的结果。对于具有相同频率的电压Vg(t)信号和电流Ig(t)信号，电压信号Vg(t)的每个负到正零点交叉触发脉冲的开始，而电流信号Ig(t)的每个负到正零点交叉触发脉冲的结束。其结果是脉冲串具有与电压信号和电流信号之间的相位角成比例的脉冲宽度。在一个方面，脉冲串可通过平均滤波器以得到相位差的测量值。此外，如果正到负零点交叉也以类似的方式使用，并且结果取平均值，则可减小DC和谐波分量的任何效果。在一个具体实施中，该模拟电压Vg(t)信号和电流Ig(t)信号被转换为数字信号，在模拟信号为正的情况下该数字信号为高的，并且在模拟信号为负的情况下该数字信号为低的。高精度相位评估需要在高值和低值之间进行急剧转变。在一个方面，可采用Schmitt触发器以及RC稳定化网络将模拟信号转换为数字信号。在其他方面，可采用边缘触发RS触发器(flip-flop)和辅助电路。在又一方面，零点交叉技术可采用异或(XOR)门。
用于确定电压信号和电流信号之间的相位差的其他技术包括Lissajous图和对图像的监测；方法，诸如三伏特计法、交叉线圈法、矢量伏特计和矢量阻抗法；以及使用相位标准器械、锁相环路、以及如Peter O’Shea、2000CRC出版有限公司<http://www.engnetbase.com>的“相位测量”(Peter O’Shea,2000CRC Press LLC,<http://www.engnetbase.com>)，该文献以引用方式并入本文。
在另一方面，例如，可监测电流反馈数据，以便将驱动信号的电流幅值保持在电流幅值设定点。电流幅值设定点可被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。在某些方面，可通过处理器1740中的控制算法(诸如例如，比例积分微分(PID)控制算法)来实现对电流幅值的控制。控制算法为了适当控制驱动信号的电流幅值而控制的变量可包括例如存储在可编程逻辑装置1660中的LUT波形样本的定标和/或经由DAC1860的DAC1680(其为功率放大器1620供应输入)的全标度输出电压。
非隔离级1540还可包括处理器1900以用于除别的之外还提供用户界面(UI)功能。在一个方面，处理器1900可包括例如购自Atmel Corporation,San Jose,Calif.的具有ARM926EJ-S核心的Atmel AT91SAM9263处理器。处理器1900所支持的UI功能的示例可包括听觉和视觉用户反馈、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1430的通信、与输入装置2150(例如，触摸屏显示器)的通信、以及与输出装置2140(例如，扬声器)的通信。处理器1900可与处理器1740和可编程逻辑装置(例如，经由串行外围接口(SPI)总线)通信。尽管处理器1900可主要支持UI功能，然而在某些方面，其也可与处理器1740配合以实现风险减缓。例如，处理器1900可被编程用于监测用户输入和/或其他输入(例如，触摸屏输入2150、脚踏开关1430输入、温度传感器输入2160)的各个方面，并且当检测到错误状况时停用发生器1100的驱动输出。
在某些方面，处理器1740(图7、图8A)和处理器1900(图7、图8B)可确定并且监测发生器1100的操作状态。对于处理器1740，发生器1100的操作状态例如可指示处理器1740实现的是哪些控制和/或诊断过程。对于处理器1900，发生器1100的操作状态例如可指示用户界面的哪些元素(例如，显示屏、声音)被呈现给用户。处理器1740、1900可独立地保持发生器1100的当前操作状态并识别和评估当前操作状态的可能转变。处理器1740可用作该关系中的主体并确定何时会发生操作状态间的转变。处理器1900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，当处理器1740指示处理器1900转变到特定状态时，处理器1900可验证所请求的转变是有效的。在处理器1900确定所请求的状态间转变是无效的情况下，处理器1900可使发生器1100进入失效模式。
非隔离级1540还可包括控制器1960(图7、图8B)，以用于监测输入装置2150(例如，用于接通和断开发生器1100的电容式触摸传感器、电容式触摸屏)。在某些方面，控制器1960可包括与处理器1900通信的至少一个处理器和/或其他控制器装置。在一个方面，例如，控制器1960可包括处理器(例如，可从Atemel购得的Mega168 8位控制器)，该处理器被配置成能够监测经由一个或多个电容式触摸传感器提供的用户输入。在一个方面，控制器1960可包括触摸屏控制器(例如，可从Atemel购得的QT5480触摸屏控制器)，以控制和管理从电容式触摸屏对触摸数据的采集。
在某些方面，当发生器1100处于“功率关”状态时，控制器1960可继续接收操作功率(例如，经由来自发生器1100的功率源(诸如以下讨论的功率源2110(图7))的管线)。以此方式，控制器1960可继续监测输入装置2150(例如，位于发生器1100的前面板上的电容式触摸传感器)，以用于接通和断开发生器1100。当发生器1100处于“功率关”状态时，如果检测到用户“接通/断开”输入装置2150的激活，则控制器1960可唤醒功率源(例如，启用功率源2110的一个或多个DC/DC电压转换器2130(图7)的操作)。因此控制器1960可开始使发生器1100转变到“功率开”状态的序列。相反，当发生器1100处于“功率开”状态时，如果检测到“接通/断开”输入装置2150的激活，则控制器1960可开始使发生器1100转变到“功率关”状态的序列。在某些方面，例如，控制器1960可向处理器1900报告“接通/断开”输入装置2150的激活，处理器1900继而实现所需的过程序列以使发生器1100转变到“功率关”状态。在此类方面，控制器1960可不具有在已建立起“功率关”状态之后从发生器1100移除功率的独立能力。
在某些方面，控制器1960可使发生器1100提供听觉或其他感观反馈，以用于警示用户“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该序列相关联的其他过程开始之前提供此警报。
在某些方面，隔离级1520可包括器械接口电路1980，以例如在外科装置的控制电路(例如，包括手持件开关的控制电路)和非隔离级1540的部件(诸如例如，可编程逻辑装置1660、处理器1740、和/或处理器1900)之间提供通信接口。器械接口电路1980可经由保持级1520、1540之间的合适的电隔离程度的通信链路(诸如例如，基于红外(IR)的通信链路)与非隔离级1540的部件交换信息。例如，可使用由隔离变压器供电的低压降电压调整器为器械接口电路1980供应功率，该低压降电压调整器从非隔离级1540被驱动。
在一个方面，器械接口电路1980可包括与信号调节电路2020(图7和图8C)通信的可编程逻辑装置2000(例如FPGA)。信号调节电路2020可被配置成能够从可编程逻辑装置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询问信号。例如，可使用由差分放大器馈送的双极电流源生成询问信号。询问信号可被发送至外科装置控制电路(例如，通过使用将发生器1100连接到外科装置的缆线中的导电对)并被监测，以确定控制电路的状态或配置。例如，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征(例如，幅值、校正)，使得可基于该一个或多个特征唯一地辨别控制电路的状态或配置。在一个方面，例如，信号调节电路2020可包括ADC，以用于生成由询问信号通过控制电路而得到的控制电路的输入中的电压信号的样本。然后，可编程逻辑装置2000(或非隔离级1540的部件)可基于ADC样本来确定控制电路的状态或配置。
在一个方面，器械接口电路1980可包括第一数据电路接口2040，以实现可编程逻辑装置2000(或器械接口电路1980的其他元件)和设置于外科装置中的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。在某些方面，例如，第一数据电路2060可设置于整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1100交接的适配器。在某些方面，第一数据电路可包括非易失性存储装置，诸如电可擦除可编程只读存储器(EEPROM)装置。在某些方面并且再次参见图7，第一数据电路接口2040可独立于可编程逻辑装置2000实现，并且包括合适的电路(例如，离散的逻辑装置、处理器)，以实现可编程逻辑装置2000和第一数据电路之间的通信。在其他方面，第一数据电路接口2040可与可编程逻辑装置2000成为整体。
在某些方面，第一数据电路2060可存储与相关联的特定外科装置相关联的信息。此类信息可包括例如型号、序列号、其中已使用外科装置的多个操作、和/或任何其他类型的信息。该信息可被器械接口电路1980(例如，通过可编程逻辑装置2000)读取、被传输至非隔离级1540的部件(例如，至可编程逻辑装置1660、处理器1740和/或处理器1900)，以经由输出装置2140呈现给用户并且/或者控制发生器1100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2040(例如，使用可编程逻辑装置2000)被发送至第一数据电路2060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1106可从手持件1107拆卸)以促进器械可互换性和/或处置性。在此类情形中，已知发生器的识别所使用特定器械配置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由于例如不同的信号方案、设计复杂性和成本而不切实际。器械的其他方面通过使用数据电路来解决这些问题，该数据电路可经济地实现于现有外科器械中并具有最小的设计变化，以保持外科装置与当前发生器平台的兼容性。
另外，发生器1100的方面可实现与基于器械的数据电路的通信。例如，发生器1100可被配置成能够与外科装置的器械(例如，器械1104、1106或1108)中所包含的第二数据电路进行通信。器械接口电路1980可包括用于实现该通信的第二数据电路接口2100。在一个方面，第二数据电路接口2100可包括三态数字接口，然而也可使用其他接口。在某些方面，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。在一个方面，第二数据电路可存储与相关联的特定外科器械相关联的信息。此类信息可包括例如型号、序列号、其中已使用外科器械的多个操作、和/或任何其他类型的信息。附加地或另选地，任何类型的信息均可经由第二数据电路接口2100(例如，使用可编程逻辑装置2000)被发送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。在某些方面，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。在某些方面，第二数据电路可从发生器1100接收数据并基于所接收的数据向用户提供指示(例如，LED指示或其他可视指示)。
在某些方面，第二数据电路和第二数据电路接口2100可被配置成使得可达成可编程逻辑装置2000和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1100的缆线的专用导体)。在一个方面，例如，可使用实施于现有缆线上的单总线通信方案(诸如用于将询问信号从信号调节电路2020传输到手持件中的控制电路的导体中的一者)而将信息传输至第二数据电路并从第二数据电路传输信息。以此方式，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，因为可在共用物理信道(具有频带分离或不具有频带分离)上实现不同类型的通信，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。
在某些方面，隔离级1520可包括至少一个阻塞电容器2960-1(图8C)，该至少一个阻塞电容器连接到驱动信号输出端1600b以防止DC电流流向患者。例如，可要求信号阻塞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失效，然而此类失效可具有负面后果。在一个方面，可设置有与阻塞电容器2960-1串联的第二阻塞电容器2960-2，其中通过例如ADC 2980来检测从阻塞电容器2960-1、2960-2之间的点发生的电流泄漏，以用于对泄漏电流所感应的电压进行采样。该样本例如可由可编程逻辑装置2000接收。基于泄漏电流的变化(如图7的方面中的电压样本所指示)，发生器1100可确定阻塞电容器2960-1、2960-2中的至少一者何时失效。因此，图7的方面相比于具有单个失效点的单个电容器设计具有益处。
在某些方面，非隔离级1540可包括功率源2110，以用于在适当的电压和电流下输出DC功率。功率源可包括例如400W的功率源用于输出48VDC的系统电压。如上所述，功率源2110还可包括一个或多个DC/DC电压转换器2130，以用于接收功率源的输出，以在发生器1100的各种部件所需的电压和电流下产生DC输出。如以上结合控制器1960所述，当控制器1960检测到用户激活“接通/断开”输入装置2150以启用DC/DC电压转换器2130的操作或唤醒DC/DC电压转换器2130时，DC/DC电压转换器2130中的一个或多个可从控制器1960接收输入。
图9A至图9B示出了发生器1100的一个方面的某些功能和结构方面。指示来自功率变压器1560的二次绕组1580的电流和电压输出的反馈分别由ADC 1780、1800接收。如图所示，ADC 1780、1800可被实现为2-信道ADC，并且可高速(例如，80Msps)对反馈信号进行采样以启用对驱动信号的过采样(例如，大约200x过采样)。在由ADC 1780、1800处理之前，电流反馈信号和电压反馈信号可在模拟域中适当调节(例如，放大、滤波)。来自ADC 1780、1800的电流和电压反馈样本可被单独缓冲，并且随后被多路复用或交插到可编程逻辑装置1660的块2120内的单个数据流中。在图9A至图9B的方面，可编程逻辑装置1660包括FPGA。
多路复用电流和电压反馈样本可由实现在处理器1740的块2144内的并行数据采集端口(PDAP)来接收。PDAP可包括用于实现用于将多路复用反馈样本与存储器地址相关联的多种方法中的任一种的封装单元。在一个方面，例如，对应于由可编程逻辑装置1660输出的特定LUT样本的反馈样本可存储在与LUT样本的LUT地址相关或建立索引的一个或多个存储器地址处。在另一方面，对应于由可编程逻辑装置1660输出的特定LUT样本的反馈样本可与LUT样本的LUT地址一起存储在公共存储器位置处。在任何情况下，反馈样本可被存储为使得可随后确定源自其的特定反馈样本集合的LUT样本的地址。如上所述，以该方式同步LUT样本地址和反馈样本有助于预失真算法的正确定时和稳定性。处理器1740的块2166处实现的直接存储器访问(DMA)控制器可在处理器1740的指定存储器位置2180(例如，内部RAM)处存储反馈样本(以及在适用的情况下存储任何LUT样本地址数据)。
处理器1740的块2200可实现预失真算法，以用于在动态行进的基础上预失真或修改存储在可编程逻辑装置1660中的LUT样本。如上所述，LUT样本的预失真可补偿发生器1100的输出驱动电路中存在的各种失真源。预失真的LUT样本在通过驱动电路进行处理时，将因此使驱动信号具有所期望的波形形状(例如，正弦形状)，以最佳地驱动超声换能器。
在预失真算法的块2220处，确定通过超声换能器的动态支路的电流。可基于例如存储在存储器位置2180处的电流和电压反馈样本(其在适当定标时可表示上文所讨论的图6的模型中的Ig和Vg)、超声换能器静态电容C0的值以及驱动频率的已知值，使用基尔霍夫电流定律来确定动态支路电流。可确定与LUT样本相关联的每组所存储的电流和电压反馈样本的动态支路电流样本。
在预失真算法的块2240处，将在块2220处确定的每个动态支路电流样本与期望的电流波形形状的样本进行比较，以确定比较的样本之间的差值或样本幅值误差。为了该确定，可例如从波形形状LUT 2260供应期望电流波形形状的样本，该波形形状LUT 2260包含期望电流波形形状的一个循环的幅值样本。用于比较的来自LUT 2260的期望电流波形形状的特定样本可由与用于比较的动态支路电流样本相关联的LUT样本地址来决定。因此，运动支路电流对块2240的输入可与其相关联的LUT样本地址的输入同步到块2240。因此，存储在可编程逻辑装置1660中的LUT样本和存储在波形形状LUT 2260中的LUT样本的数量可相等。在某些方面，由存储在波形形状LUT 2260中的LUT样本表示的期望电流波形形状可为基本正弦波。其他波形形状可为期望的。例如，可以设想可使用用于驱动在其他频率下与一个或多个其他驱动信号叠加的超声换能器的主纵向运动的基本正弦波，诸如用于驱动用于横向或其他模式的有利振动的至少两个机械谐振的三阶谐波。
在块2240处确定的样本幅值误差的每个值可连同其相关联的LUT地址的指示一起被传输到可编程逻辑装置1660的LUT(在图9A中的块2280处示出)。基于样本幅值误差的值及其相关联的地址(以及任选地，先前接收的相同LUT地址的样本幅值误差的值)，LUT 2280(或可编程逻辑装置1660的其他控制块)可预失真或修改存储在LUT地址处的LUT样本的值，使得样本幅值误差减小或最小化。应当理解，在整个LUT地址范围内以迭代方式对每个LUT样本进行此类预失真或修改将导致发生器的输出电流的波形形状匹配或适形于波形形状LUT 2260的样本所表示的期望电流波形形状。
电流和电压幅值测量值、功率测量值和阻抗测量值可在处理器1740的块2300处基于存储在存储器位置2180处的电流和电压反馈样本来确定。在确定这些量之前，反馈样本可被适当地定标，并且在某些方面，通过合适的滤波器2320进行处理以移除由例如数据采集过程和感应的谐波分量得到的噪声。因此，滤波后的电压和电流样本可大体上表示发生器的驱动输出信号的基频。在某些方面，滤波器2320可为应用于频域的有限脉冲响应(FIR)滤波器。此类方面可使用输出驱动信号电流和电压信号的快速傅里叶变换(FFT)。在某些方面，所得频谱可用于提供附加的发生器功能。在一个方面，例如，第二阶谐波分量和/或第三阶谐波分量相对于基频分量的比可用作诊断指示符。
在块2340(图9B)处，可对表示整数循环的驱动信号的一定样本大小的电流反馈样本应用均方根(RMS)计算，以生成表示驱动信号输出电流的测量值Irms。
在块2360处，可对表示整数循环的驱动信号的一定样本大小的电压反馈样本应用均方根(RMS)计算，以确定表示驱动信号输出电压的测量值Vrms。
在块2380处，可将电流和电压反馈样本进行逐点相乘，并且可对表示整数循环的驱动信号的样本进行平均计算，以确定发生器的真实输出功率的测量值Pr。
在块2400处，发生器的表观输出功率的测量值Pa可被确定为乘积Vrms·Irms。
在块2420处，负载阻抗幅值的测量值Zm可被确定为商数Vrms/Irms。
在某些方面，在块2340、2360、2380、2400和2420处确定的量Irms、Vrms、Pr、Pa和Zm可被发生器1100用于实现多个控制和/或诊断过程中的任一者。在某些方面，这些量中的任一者可经由例如与发生器1100形成整体的输出装置2140或通过合适的通信接口(例如，USB接口)连接到发生器1100的输出装置2140来传送至用户。例如，各种诊断过程可包括但不限于手持件完整性、器械完整性、器械附接完整性、器械过载、接近器械过载、频率锁定失效、过电流状况、过功率状况、电压感测失效、电流感测失效、音频指示失效、视觉指示失效、短路状况、功率递送失效或阻塞电容器失效。
处理器1740的块2440可实现用于确定和控制由发生器1100驱动的电力负载(例如，超声换能器)的阻抗相位的相位控制算法。如上所述，通过控制驱动信号的频率以最小化或减小所确定的阻抗相位和阻抗相位设定点(例如，0°)之间的差值，可最小化或减小谐波失真的影响，并且相位测量的准确性增加。
相位控制算法接收存储在存储器位置2180中的电流和电压反馈样本作为输入。在将反馈样本用于相位控制算法之前，反馈样本可被适当定标，并且在某些方面通过合适的滤波器2460(其可与滤波器2320相同)进行处理以移除例如数据采集过程和感应的谐波分量得到的噪声。因此，滤波后的电压和电流样本可大体上表示发生器的驱动输出信号的基频。
在相位控制算法的块2480处，确定通过超声换能器的动态支路的电流。该确定可与上文结合预失真算法的块2220所述的确定相同。因此，对于与LUT样本相关联的每组所存储的电流和电压反馈样本，块2480的输出可为动态支路电流样本。
在相位控制算法的块2500处，基于在块2480处确定的动态支路电流样本的同步输入和对应的电压反馈样本来确定阻抗相位。在某些方面，阻抗相位被确定为在波形上升沿处测量的阻抗相位和在波形的下降沿处测量的阻抗相位的平均值。
在相位控制算法的块2520处，将在块2220处确定的阻抗相位值与相位设定点2540进行比较，以确定所比较值之间的差值或相位误差。
在相位控制算法的块2560(图9A)处，基于在块2520处确定的相位误差的值和在块2420处确定的阻抗幅值，确定用于控制驱动信号的频率的频率输出。频率输出的值可由块2560连续调节并传输至DDS控制块2680(下文讨论)，以便将在块2500处确定的阻抗相位保持在相位设定点处(例如，零相位误差)。在某些方面，阻抗相位可被调整至0°相位设定点。这样，任何谐波失真将围绕电压波形的波峰居中，从而增强相位阻抗确定的准确性。
处理器1740的块2580可实现用于调制驱动信号的电流幅值的算法，以便根据用户指定的设定点或根据由发生器1100实现的其他过程或算法所指定的要求来控制驱动信号电流、电压和功率。这些量的控制可例如通过定标LUT 2280中的LUT样本并且/或者通过经由DAC 1860调节DAC1680(其向功率放大器1620供应输入)的全标度输出电压来实现。块2600(其在某些方面可被实现为PID控制器)可接收来自存储器位置2180的电流反馈样本(其可被适当地定标和滤波)作为输入。可将电流反馈样本与由受控变量(例如，电流、电压或功率)规定的“电流需求”Id值进行比较，以确定驱动信号是否供应必要的电流。在驱动信号电流为控制变量的方面，电流需求Id可由电流设定点2620A(Isp)直接指定。例如，可将电流反馈数据的RMS值(如块2340中所确定)与用户指定的RMS电流设定点Isp进行比较以确定适当的控制器动作。例如，如果电流反馈数据指示RMS值小于电流设定点Isp，则DAC 1680的LUT定标和/或全标度输出电压可由块2600调节，使得驱动信号电流增加。相反，当电流反馈数据指示RMS值大于电流设定点Isp时，块2600可调节DAC 1680的LUT定标和/或全标度输出电压以降低驱动信号电流。
在驱动信号电压为控制变量的方面，电流需求Id可例如基于保持在块2420处测量的负载阻抗幅值Zm给出的期望电压设定点2620B(Vsp)所期望的电流间接指定(例如，Id＝Vsp/Zm)。相似地，在驱动信号功率为控制变量的方面，电流需求Id可例如基于在块2360处测量的电压Vrms给出的期望设定点2620C(Psp)所期望的电流间接指定(例如，Id＝Psp/Vrms)。
块2680(图9A)可实现DDS控制算法，用于通过检索存储在LUT2280中的LUT样本来控制驱动信号。在某些方面，DDS控制算法可为数字控制振荡器(NCO)算法，以用于使用点(存储器位置)-跳过技术以固定时钟速率生成波形的样本。NCO算法可实现相位累加器或频率到相位转换器，其用作地址指针以用于从LUT 2280中检索LUT样本。在一个方面，相位累加器可为D步长、模量N的相位累加器，其中D是表示频率控制值的正整数，并且N是LUT 2280中的LUT样本的数量。例如，D＝1的频率控制值可使得相位累加器顺序地指向LUT 2280的每个地址，从而得到复制存储在LUT 2280中的波形的波形输出。当D>1时，相位累加器可跳过LUT 2280中的地址，从而得到具有更高频率的波形输出。因此，由DDS控制算法生成的波形的频率可因此通过适当地改变频率控制值来控制。在某些方面，频率控制值可基于在块2440处实现的相位控制算法的输出来确定。块2680的输出可供应DAC 1680的输入，DAC1680继而向功率放大器1620的输入供应对应的模拟信号。
处理器1740的块2700可实现开关模式转换器控制算法，以用于基于被放大信号的波形包络动态地调制功率放大器1620的干线电压，从而提高功率放大器1620的效率。在某些方面，波形包络的特征可通过监测功率放大器1620中包含的一个或多个信号来确定。在一个方面，例如，可通过监测根据放大信号的包络调制的漏极电压(例如，MOSFET漏极电压)的最小值来确定波形包络的特征。可例如通过联接到漏极电压的电压最小值检测器来生成最小电压信号。最小值电压信号可由ADC 1760取样，其中输出最小值电压样本在开关模式转换器控制算法的块2720处被接收。基于最小值电压样本的值，块2740可控制由PWM发生器2760输出的PWM信号，该PWM发生器2760继而控制由开关模式调整器1700供应给功率放大器1620的干线电压。在某些方面，只要最小值电压样本的值小于输入到块2720中的最小值目标2780，则可根据由最小值电压样本表征的波形包络来调制干线电压。例如，当最小值电压样本指示低包络功率水平时，块2740可导致向功率放大器1620供应低干线电压，其中仅当最小值电压样本指示最大包络功率水平时供应全干线电压。当最小值电压样本落到低于最小值目标2780时，块2740可使得干线电压保持在适于确保功率放大器1620的正确操作的最小值。
图10示出了控制电路500，该控制电路被配置成能够控制根据本公开的一个方面的外科器械或工具的各方面。控制电路500可被配置成能够实现本文所述的各种过程。控制电路500可包括微控制器，该微控制器包括联接到至少一个存储器电路504的一个或多个处理器502(例如，微处理器、微控制器)。存储器电路504存储在由处理器502执行时使处理器502执行机器指令以实现本文所述的各种过程的机器可执行指令。处理器502可为本领域中已知的多种单核或多核处理器中的任一种。存储器电路504可包括易失性存储介质和非易失性存储介质。处理器502可包括指令处理单元506和运算单元508。指令处理单元可被配置成能够从本公开的存储器电路504接收指令。
图11示出了组合逻辑电路510，该组合逻辑电路被配置成能够控制根据本公开的一个方面的外科器械或工具的各方面。组合逻辑电路510可被配置成能够实现本文所述的各种过程。组合逻辑电路510可包括有限状态机，该有限状态机包括组合逻辑512，该组合逻辑被配置成能够在输入514处接收与外科器械或工具相关联的数据，通过组合逻辑512处理数据并提供输出516。
图12示出了根据本公开的一个方面的被配置成能够控制外科器械或工具的各方面的时序逻辑电路520。时序逻辑电路520或组合逻辑522可被配置成能够实现本文所述的各种过程。时序逻辑电路520可包括有限状态机。时序逻辑电路520可包括例如组合逻辑522、至少一个存储器电路524和时钟529。至少一个存储器电路524可以存储有限状态机的当前状态。在某些情况下，时序逻辑电路520可为同步的或异步的。组合逻辑522被配置成能够从输入526接收与外科器械或工具相关联的数据，通过组合逻辑522处理数据并提供输出528。在其他方面，电路可包括处理器(例如，处理器502，图13)和有限状态机的组合以实现本文的各种过程。在其他方面，有限状态机可包括组合逻辑电路(例如，组合逻辑电路510，图14)和时序逻辑电路520的组合。
在一个方面，外科系统1000的超声或高频电流发生器可被配置成能够数字地生成电信号波形，使得期望的使用存储在查找表中的预定数量的相位点来数字化波形。相位点可存储在限定于存储器、场可编程门阵列(FPGA)或任何合适的非易失性存储器中的表中。图13示出了数字合成电路诸如直接数字合成(DDS)电路4100的基本架构的一个方面，该DDS电路被配置成能够生成电信号波形的多个波形状。发生器软件和数字控件可命令FPGA扫描查找表4104中的地址，该查找表4104继而向馈送功率放大器的DAC电路4108提供变化的数字输入值。可根据感兴趣的频率扫描地址。使用此查找表4104能够生成各种类型的波形，该波形可同时被馈送到组织或换能器、RF电极中、同时被馈送到多个换能器中、同时被馈送到多个RF电极中、或被馈送到RF器械和超声器械的组合中。此外，可从发生器创建、存储和向组织施加表示多个波形状的多个查找表4104。
波形信号可被配置成能够控制超声换能器和/或RF电极或其倍数(例如，两个或更多个超声换能器和/或两个或更多个RF电极)的输出电流、输出电压、或输出功率中的至少一者。另外，在外科器械包括超声部件的情况下，波形信号可被配置成能够驱动至少一个外科器械的超声换能器的至少两个振动模式。因此，发生器可被配置成能够向至少一个外科器械提供波形信号，其中波形信号对应于表中多个波形状中的至少一个波形状。另外，提供给两个外科器械的波形信号可包括两个或更多个波形状。该表可包括与多个波形状相关联的信息，并且该表可存储在发生器内。在一个方面或示例中，该表可为可存储在发生器的FPGA中的直接数字合成表。可通过方便对波形状进行分类的任何方式来寻址该表。根据一个方面，根据波形信号的频率来寻址该表(其可为直接数字合成表)。另外，与所述多个波形状相关联的信息可作为数字信息存储在表中。
模拟电信号波形可被配置成能够控制超声换能器和/或RF电极或其倍数(例如，两个或更多个超声换能器和/或两个或更多个RF电极)的输出电流、输出电压或输出功率中的至少一者。另外，在外科器械包括超声部件的情况下，模拟电信号波形可被配置成能够驱动至少一个外科器械的超声换能器的至少两个振动模式。因此，发生器电路可被配置成能够向至少一个外科器械提供模拟电信号波形，其中模拟电信号波形对应于存储在查找表4104中的多个波形状中的至少一个波形状。另外，提供给两个外科器械的模拟电信号波形可包括两个或更多个波形状。查找表4104可包括与多个波形状相关联的信息，并且查找表4104可存储在发生器电路或外科器械内。在一个方面或示例中，查找表4104可为直接数字合成表，其可存储在发生器电路或外科器械的FPGA中。查找表4104可通过方便地对波形状进行分类的任何方式来寻址。根据一个方面，查找表4104(其可为直接数字合成表)根据期望的模拟电信号波形的频率来寻址。另外，与所述多个波形状相关联的信息可作为数字信息存储在查找表4104中。
随着在器械和通信系统中广泛使用数字技术，从参考频率源生成多个频率的数字控制方法已经演进，并且被称为直接数字合成。基础架构示于图13中。在该简化框图中，DDS电路联接到发生器电路的处理器、控制器、或逻辑装置，并且耦合到位于外科系统1000的发生器电路中的存储器电路。DDS电路4100包括地址计数器4102、查找表4104、寄存器4106、DAC电路4108和滤波器4112。稳定时钟fc由地址计数器4102接收，并且寄存器4106驱动可编程只读存储器(PROM)，该可编程只读存储器将正弦波(或其他任意波形)的一个或多个整数循环存储在查找表4104中。当地址计数器4102步进通过存储器位置时，存储在查找表4104中的值被写入寄存器4106，该寄存器4106联接到DAC电路4108。在查找表4104的存储器位置处的信号的对应数字幅值驱动DAC电路4108，该DAC电路4108继而生成模拟输出信号4110。模拟输出信号4110的光谱纯度主要由DAC电路4108确定。相位噪声基本上是基准时钟fc的相位噪声。从DAC电路4108输出的第一模拟输出信号4110被滤波器4112滤波，并且由滤波器4112输出的第二模拟输出信号4114被提供给放大器，该放大器的输出端联接到发生器电路的输出端。第二模拟输出信号具有频率f输出。
因为DDS电路4100是取样数据系统，所以必须考虑取样中涉及的问题：量化噪声、混叠、滤波等。例如，DAC电路4108输出频率的更高阶谐波折返回到Nyquist带宽中，使得它们不可滤波，而基于锁相环路(PLL)的合成器的输出的高阶谐波可被滤波。查找表4104包含整数个循环的信号数据。可通过改变基准时钟频率fc或通过重新编程PROM来改变最终输出频率f输出。
DDS电路4100可包括多个查找表4104，其中查找表4104存储由预定数量的样本表示的波形，其中样本限定波形的预定形状。因此，可将具有独特形状的多个波形存储在多个查找表4104中，以基于器械设置或组织反馈提供不同的组织处理。波形的示例包括用于表面组织凝固的高波峰因数RF电信号波形、用于更深组织渗透的低波峰因数RF电信号波形、以及促进有效触摸凝固的电信号波形。在一个方面，DDS电路4100可创建多个波形状查找表4104，并且在组织处理过程期间(例如，基于用户或传感器输入的“即时(on-the-fly)”或虚拟实时)，基于期望的组织效应和/或组织反馈，在存储在单独查找表4104中的不同波形状之间切换。因此，波形状之间的切换可基于例如组织阻抗和其他因素。在其他方面，查找表4104可存储电信号波形，该电信号波形被成形为使每个循环递送到组织中的功率最大化(即，梯形或方波)。在其他方面，查找表4104可存储以此类方式同步的波形，该方式使得外科系统1000的多功能外科器械在递送RF驱动信号和超声驱动信号时的功率递送最大化。在其他方面，查找表4104可存储电信号波形，以同时驱动超声能量和RF治疗能量、以及/或者子治疗能量，同时保持超声锁定。特定于不同器械的定制波形状及其组织效应可存储在发生器电路的非易失性存储器中或外科系统1000的非易失性存储器(例如，EEPROM)中，并且在将多功能外科器械连接到发生器电路时被提取。如在许多高波峰因数“凝固”波形中使用的指数衰减正弦曲线的示例在图15中示出。
DDS电路4100的更灵活和有效的具体实施采用被称为数字控制振荡器(NCO)的数字电路。更灵活和有效的数字合成电路诸如DDS电路4200的框图在图14中示出。在该简化框图中，DDS电路4200联接到发生器的处理器、控制器、或逻辑装置，并且连接到位于发生器中或外科系统1000的外科器械中的任一者中的存储器电路。DDS电路4200包括负载寄存器4202、并行增量相位寄存器4204、加法器电路4216、相位寄存器4208、查找表4210(相位到幅值转换器)、DAC电路4212、和滤波器4214。加法器电路4216和相位寄存器4208形成相累加器4206的一部分。时钟频率fc被施加到相位寄存器4208和DAC电路4212。负载寄存器4202接收将输出频率指定为参考时钟频率信号fc的分数的调谐字。负载寄存器4202的输出以调谐字M提供给并行增量相位寄存器4204。
DDS电路4200包括生成时钟频率fc的采样时钟、相位累加器4206和查找表4210(例如，相位到幅值转换器)。每个时钟循环fc更新一次相位累加器4206的内容。当更新相位累加器4206的时间时，通过加法器电路4216将存储在并联增量相位寄存器4204中的数字M添加至相位寄存器4208中的数字。假设并联增量相位寄存器4204中的数字为00...01并且相位累加器4206的初始内容为00...00。相位累加器4206每个时钟循环更新00...01。如果相位累加器4206为32位宽，则在相位累加器4206返回至00...00之前需要232个时钟循环(超过40亿)，并且重复该循环。
将相位累加器4206的截断的输出4218提供到相位到幅值转换器查找表4210，并且查找表4210的输出联接到DAC电路4212。相位累加器4206的截断的输出4218充当正弦(或余弦)查找表的地址。查找表中的地址对应于从0°到360°的正弦波上的相位点。查找表4210包含正弦波的一个完整循环的对应数字幅值信息。因此，查找表4210将来自相位累加器4206的相位信息映射到数字幅值字，该数字幅值字继而驱动DAC电路4212。DAC电路的输出为第一模拟信号4220并且通过滤波器4214进行滤波。滤波器4214的输出为第二模拟信号4222，该模拟信号被提供给联接到发生器电路的输出端的功率放大器。
在一个方面，电信号波形可被数字化为1024(210)个相位点，但波形状可被数字化为256(28)至281,474,976,710,656(248)范围内的任何合适数量的2n相位点，其中n为正整数，如表1中所示。电信号波形可表示为An(θn)，其中点n处的归一化幅值An由被称为点n处的相位点的相位角θn表示。离散相位点的数量n确定DDS电路4200(以及图13中所示的DDS电路4100)的调谐分辨率。
表1指定被数字化为多个相位点的电信号波形。
N 相位点数2<sup>n</sup>
8 256
10 1,024
12 4,096
14 16,384
16 65,536
18 262,144
20 1,048,576
22 4,194,304
24 16,777,216
26 67,108,864
28 268,435,456
... ...
32 4,294,967,296
... ...
48 281,474,976,710,656
... ...
表1
发生器电路算法和数字控制电路扫描查找表4210中的地址，该查找表4210继而向馈送滤波器4214和功率放大器的DAC电路4212提供变化的数字输入值。可根据感兴趣的频率扫描地址。使用查找表能够生成各种类型的形状，这些形状可被DAC电路4212转换为模拟输出信号、通过滤波器4214进行滤波、通过联接到发生器电路的输出端的功率放大器放大、并且以RF能量的形式被馈送至组织或被馈送至超声换能器、并且以超声振动的形式被施加到组织，该超声振动以热的形式将能量递送到组织。放大器的输出可例如被施加到RF电极、被同时施加到多个RF电极、被施加到超声换能器、被同时施加到多个超声换能器、或者被施加到RF和超声换能器的组合。此外，可从发生器电路创建、存储多个波形表并将其施加到组织。
重新参考图13，对于n＝32和M＝1，相位累加器4206在其溢出和重启之前步进通过232个可能的输出。对应的输出波频率等于输入时钟频率除以232。如果M＝2，则相位寄存器1708“翻转(rolls over)”两倍快，并且输出频率加倍。这可被归纳如下。
对于被配置成能够累积n位的相位累加器4206(在大多数DDS系统中n通常在24至32的范围内，但如前所述n可选自广泛的选项)，存在2n个可能的相位点。增量相位寄存器中的数字字M表示相位累加器每时钟循环递增的量。如果fc为时钟频率，则输出正弦波的频率等于：
Figure BDA0002671339460000571
上述方程被称为DDS“调谐方程”。注意，系统的频率分辨率等于
Figure BDA0002671339460000572
对于n＝32，该分辨率大于四十亿分之一。在DDS电路4200的一个方面，不是所有来自相位累加器4206的位都被传递到查找表4210，而是被截断，仅留下例如前13至15个最高有效位(MSB)。这减小了查找表4210的大小并且不影响频率分辨率。相位截断仅向最终输出添加小但可接受量的相位噪声。
电信号波形可通过预定频率下的电流、电压或功率来表征。另外，在外科系统1000的外科器械中的任一个包括超声部件的情况下，电信号波形可被配置成能够驱动至少一个外科器械的超声换能器的至少两个振动模式。因此，发生器电路可被配置成能够向至少一个外科器械提供电信号波形，其中该电信号波形通过存储在查找表4210(或图13的查找表4104)中的预定的波形状来表征。此外，电信号波形可为两个或更多个波形状的组合。查找表4210可包括与多个波形状相关联的信息。在一个方面或示例中，查找表4210可由DDS电路4200生成，并且可被称为直接数字合成表。DDS通过首先在板载存储器中存储大量重复波形来工作。波形(正弦、三角形、正方形、任意)的循环可由如表1中所示的预定数量的相位点表示并被存储到存储器中。一旦波形被存储到存储器中，其就可以在非常精确的频率下生成。直接数字合成表可被存储在发生器电路的非易失性存储器中并且/或者可用发生器电路中的FPGA电路来实现。查找表4210可通过方便对波形状进行分类的任何合适的技术来寻址。根据一个方面，查找表4210根据电信号波形的频率来寻址。另外，与所述多个波形状相关联的信息可作为数字信息或作为查找表4210的一部分存储在存储器中。
在一个方面，发生器电路可被配置成能够同时向至少两个外科器械提供电信号波形。发生器电路还可被配置成能够经由发生器电路的输出信道同时向两个外科器械提供电信号波形，该电信号波形可通过两个或更多个波形来表征。例如，在一个方面，电信号波形包括用于驱动超声换能器的第一电信号(例如，超声驱动信号)、第二RF驱动信号、和/或它们的组合。此外，电信号波形可包括多个超声驱动信号、多个RF驱动信号、和/或多个超声驱动信号和RF驱动信号的组合。
此外，操作根据本公开的发生器电路的方法包括生成电信号波形并向外科系统1000的外科器械中的任一个提供所生成的电信号波形，其中生成电信号波形包括从存储器接收与电信号波形相关联的信息。所生成的电信号波形包括至少一个波形状。此外，向至少一个外科器械提供所生成的电信号波形包括同时向至少两个外科器械提供电信号波形。
如本文所述的发生器电路可允许生成各种类型的直接数字合成表。由发生器电路生成的适用于处理多种组织的RF/电外科信号的波形状的示例包括具有高波峰因数的RF信号(其可用于RF模式下的表面凝固)、低波峰因数RF信号(其可用于更深的组织渗透)、以及促进有效的触摸凝固的波形。发生器电路还可采用直接数字合成查找表4210来生成多个波形状，并且可基于期望的组织效应在特定的波形状之间快速切换。切换可基于组织阻抗和/或其他因素。
除了传统的正弦/余弦波形状之外，发生器电路还可被配置成能够产生使每个循环中进入组织的功率最大化的一个或多个波形状(即，梯形或方波)。发生器电路可提供一个或多个波形状，该一个或多个波形状被同步以在同时驱动RF信号和超声信号时使递送到负载的功率最大化并保持超声锁定，前提条件是发生器电路包括能够同时驱动RF信号和超声信号的电路拓扑结构。另外，专用于器械及其组织效应的定制波形状可存储在非易失性存储器(NVM)或器械EEPROM中，并且可在将外科系统1000的外科器械中的任一个连接至发生器电路时被提取。
DDS电路4200可包括多个查找表4104，其中查找表4210存储由预定数量的相位点(也可称为样本)表示的波形，其中相位点限定波形的预定形状。因此，可将具有独特形状的多个波形存储在多个查找表4210中，以基于器械设置或组织反馈提供不同的组织处理。波形的示例包括用于表面组织凝固的高波峰因数RF电信号波形、用于更深组织渗透的低波峰因数RF电信号波形、以及促进有效触摸凝固的电信号波形。在一个方面，DDS电路4200可创建多个波形状查找表4210，并且在组织处理过程期间(例如，基于用户或传感器输入的“即时(on-the-fly)”或虚拟实时)，基于期望的组织效应和/或组织反馈，在存储在不同查找表4210中的不同波形状之间切换。因此，波形状之间的切换可基于例如组织阻抗和其他因素。在其他方面，查找表4210可存储电信号波形，该电信号波形被成形为使每个循环递送到组织中的功率最大化(即，梯形或方波)。在其他方面，查找表4210可存储以此类方式同步的波形状，该方式为当递送RF信号和超声驱动信号时，它们通过外科系统1000的外科器械中的任一者使功率递送最大化。在其他方面，查找表4210可存储电信号波形，以同时驱动超声能量和RF治疗能量、和/或子治疗能量，同时维持超声锁定。一般来讲，输出波形状可为正弦波、余弦波、脉冲波、方波等的形式。然而，特定于不同器械的更复杂且定制的波形及其组织效应可存储在发生器电路的非易失性存储器或外科器械的非易失性存储器(例如，EEPROM)中，并且在将外科器械连接到发生器电路时被提取。定制波形状的一个示例是如在许多高波峰因数“凝固”波形中使用的指数衰减正弦曲线，如图43中所示。
图15示出了模拟波形4304的根据本公开的至少一个方面的离散时间数字电信号波形4300的一个循环(示出为叠加在离散时间数字电信号波形4300上以用于比较)。水平轴表示时间(t)，而垂直轴表示数字相位点。数字电信号波形4300是例如期望模拟波形4304的数字离散时间型式。通过存储幅值相位点4302来生成数字电信号波形4300，该幅值相位点表示一个循环或周期To上每个时钟循环Tclk的幅值。数字电信号波形4300通过任何合适的数字处理电路在一个周期To上生成。幅值相位点是存储在存储器电路中的数字字。在图13、图14中所示的示例中，数字字是能够以26位或64位的分辨率存储幅值相位点的六位字。应当理解，图13、图14中所示的示例用于示例性目的，并且在实际具体实施中，分辨率可更高。在一个循环To上的数字幅值相位点4302作为在查找表4104、4210中的一串字串存储在存储器中，如结合例如图13、图14所述。为了生成模拟波形4304的模拟型式，从存储器按时钟循环Tclk从0至To依次读取幅值相位点4302，并且由DAC电路4108、4212转换，还结合图13、图14进行了描述。可通过将数字电信号波形4300的幅值相位点4302从0至To反复读取尽可能期望的可能多的循环或周期来生成附加的循环。通过用滤波器4112、4214(图13和图14)对DAC电路4108、4212的输出进行滤波来实现模拟波形4304的平滑模拟型式。将滤波后的模拟输出信号4114、4222(图13和图14)施加到功率放大器的输入端。
图16为可被实现为嵌套PID反馈控制器的控制系统12950的图示。PID控制器是控制环路反馈机构(控制器)，其用于将误差值连续地计算期望的设定点和测量的过程变量之间的差值，并基于比例、积分和导数项(有时分别表示为P、I和D)施加校正。嵌套PID控制器反馈控制系统12950包括初级(外部)反馈环路12954中的主控制器12952和次级(内部)反馈环路12956中的次级控制器12955。主控制器12952可为如图17中所示的PID控制器12972，并且次级控制器12955也可为如图17中所示的PID控制器12972。主控制器12952控制主要过程12958，并且次级控制器12955控制次级过程12960。主要过程12958的输出12966为从主设定点SP1减去第一求和器12962。第一求和器12962产生施加到主控制器12952的单个和输出信号。主控制器12952的输出为次级设定点SP2。次级过程12960的输出12968为从次级设定点SP2减去第二求和器12964。
图17示出了根据本公开的一个方面的PID反馈控制系统12970。主控制器12952或次级控制器12955或两者可被实现为PID控制器12972。在一个方面，PID控制器12972可包括比例元件12974(P)、积分元件12976(I)和导数元件12978(D)。P元件12974、I元件12976、D元件12978的输出由求和器12986求和，该求和器12986向过程12980提供控制变量μ(t)。过程12980的输出为过程变量y(t)。求和器12984计算期望的设定点r(t)和测量的过程变量y(t)之间的差值。PID控制器12972连续地计算误差值e(t)(例如，闭合力阈值和测得的闭合力之间的差值)作为期望的设定点r(t)(例如，闭合力阈值)和测量的过程变量y(t)(例如，闭合管的速度和方向)之间的差值，并且基于分别由比例元件12974(P)、积分元件12976(I)和导数元件12978(D)计算出的比例、积分和导数项来施加校正。PID控制器12972尝试通过调节控制变量μ(t)(例如，闭合管的速度和方向)来最小化随时间推移的误差e(t)。
根据PID算法，“P”元件12974计算误差的当前值。例如，如果误差为大的且为正的，那么控制输出也将为大的和正的。根据本公开，误差项e(t)在闭合管的期望闭合力和所测量的闭合力之间是不同的。“I”元件12976计算误差的过去值。例如，如果当前输出不够强，那么误差的积分会随着时间推移而累积，并且控制器将通过施加更强的动作进行响应。“D”元件12978基于其当前的变化率计算该误差的未来可能趋势。例如，在继续上述P示例的情况下，当大的正控制输出成功地使误差更接近于零时，它也将进程置于最近的将来的大的负误差的路径中。在这种情况下，导数变为负，并且D模块减小动作的强度以防止该过冲。
应当理解，可根据反馈控制系统12950、12970来监测和控制其他变量和设定点。例如，本文所述的自适应闭合构件速度控制算法可测量以下参数中的至少两个：击发构件行程位置、击发构件负载、切割元件的位移、切割元件的速度、闭合管行程位置、闭合管负载等等。
图18为根据本公开的至少一个方面的用于控制超声机电系统132002的频率并且检测其阻抗的替代系统132000。系统132000可被结合到发生器中。联接到存储器132026的处理器132004对可编程计数器132006编程以调谐至超声机电系统132002的输出频率fo。输入频率由晶体振荡器132008生成，并且被输入到固定计数器132010中以将频率定标至合适的值。固定计数器132010和可编程计数器132006的输出被施加到相位/频率检测器132012。相位/频率检测器132012的输出被施加到放大器/有源滤波器电路132014以生成施加到电压控制振荡器132016(VCO)的调谐电压Vt。VCO 132016将输出频率fo施加到超声机电系统132002的超声换能器部分，本文所示将其建模为等效电路。施加到超声换能器的电压信号和电流信号由电压传感器132018和电流传感器132020监测。
电压传感器132018和电流传感器13020的输出被施加到另一个相位/频率检测器132022以确定如电压传感器132018和电流传感器13020所测量的电压和电流之间的相位角。相位/频率检测器132022的输出被施加到高速模数转换器132024(ADC)的一个信道，并且通过其提供给处理器132004。任选地，电压传感器132018和电流传感器132020的输出可被施加到双信道ADC 132024的相应信道并且被提供给处理器132004用于零点交叉、FFT或本文所述的其他算法，以用于确定施加到超声机电系统132002的电压信号和电流信号之间的相位角。
任选地调谐电压Vt(该电压与输出频率fo成比例)可经由ADC 132024反馈回处理器132004。这将向处理器132004提供与输出频率fo成比例的反馈信号，并且可以使用该反馈来调节并控制输出频率fo。
评估钳口的状态(垫烧穿、钉、断裂的刀、钳口中的骨、钳口中的组织)
超声能量递送的挑战在于，在错误的材料或错误的组织上施加超声声音会导致装置失效，例如夹持臂垫烧穿或超声刀断裂。还希望在不在钳口中添加附加传感器的情况下检测什么位于超声装置的端部执行器的钳口中以及钳口的状态。将传感器定位在超声端部执行器的钳口中具有可靠性、成本和复杂性方面的挑战。
根据本公开的至少一个方面，可采用超声光谱智能刀算法技术基于被配置成能够驱动超声换能器刀的超声换能器的阻抗
Figure BDA0002671339460000621
来评估钳口的状态(夹持臂垫烧穿、钉、断裂的刀、钳口中的骨、钳口中的组织、钳口闭合时的背切等)。绘制阻抗Zg(t)、幅值|Z|和相位
Figure BDA0002671339460000622
作为频率f的函数。
动态力学分析(DMA，也称为动态力学光谱学或简称为力学光谱学)是一种用于研究和表征材料的技术。将正弦应力施加到材料上，并测量材料中的应变，从而可以确定材料的复数模量。应用于超声装置的光谱学包括通过频率扫描(复合信号或传统频率扫描)来激发超声刀的末端，以及测量在每个频率下的所得复阻抗。将超声换能器在一定频率范围内的复阻抗测量值用于分类器或模型中，以推断超声端部执行器的特征。在一个方面，本公开提供了一种用于确定超声端部执行器(夹持臂、钳口)的状态以驱动超声装置中的自动化(诸如停用功率以保护装置、执行自适应算法、检索信息、识别组织等)的技术。
图19为根据本公开的至少一个方面的具有端部执行器的多种不同状态和状况的超声装置的光谱132030，其中阻抗Zg(t)、幅值|Z|和相位
Figure BDA0002671339460000623
被绘制为频率f的函数。光谱图132030在三维空间中绘制，其中频率(Hz)沿x轴绘制，相位(Rad)沿y轴绘制，幅值(欧姆)沿z轴绘制。
在不同状况和状态的频率范围内，对不同钳口咬合和装置状态的频谱分析会产生不同的复阻抗特征图案(指纹)。当绘制时，每个状态或状况在3D空间中都具有不同的特征图案。这些特征图案可用于评估端部执行器的状况和状态。图19示出了空气132032、夹持臂垫132034、油鞣革132036、钉132038和断裂的刀132040的光谱。油鞣革132036可用于表征不同类型的组织。
可以通过在超声换能器上施加低功率电信号以产生超声刀的非治疗激发来评估光谱图132030。低功率电信号可以扫描或复合傅立叶级数的形式施加，以使用FFT在串联(扫描)或并联(复合信号)频率范围内测量超声换能器上的阻抗
Figure BDA0002671339460000631
新数据的分类方法
对于每种特征图案，可以将参数线拟合为使用多项式、傅立叶级数或方便的任何其他形式的参数方程进行训练所使用的数据。然后接收新的数据点，并通过使用从该新的数据点到已拟合为特征图案训练数据的轨迹的欧几里得垂直距离度该新的数据点进行分类。该新的数据点到每个轨迹(每个轨迹表示不同状态或状况)的垂直距离用于将该点指定给某一状态或状况。
可以将训练数据中每个点到拟合曲线的距离的概率分布用于评估正确分类的新数据点的概率。这实质上在拟合轨迹的每个新数据点处在垂直于拟合轨迹的平面中构造了二维概率分布。然后，可以基于新数据点的正确分类概率将该新数据点包括在训练集中，以形成自适应学习分类器，该分类器可以轻松检测状态的高频变化，但可以适应系统性能缓慢发生的偏差，诸如装置变脏或垫磨损。
图20为根据本公开的至少一个方面的一组3D训练数据集(S)的曲线图132042的图形表示，其中超声换能器阻抗Zg(t)、幅值|Z|和相位
Figure BDA0002671339460000632
被绘制为频率f的函数。3D训练数据集(S)曲线132042在三维空间中以图形方式描绘，其中相位(Rad)沿x轴绘制，频率(Hz)沿y轴绘制，幅值(欧姆)沿z轴绘制，并且参数傅立叶级数被拟合到3D训练数据集(S)。用于数据分类的方法基于3D训练数据集(S0用于生成曲线图132042)。
拟合到3D训练数据集(S)的参数傅立叶级数由下式定义：
Figure BDA0002671339460000633
对于新的点
Figure BDA0002671339460000634
从
Figure BDA0002671339460000635
到
Figure BDA0002671339460000636
的垂直距离为：
Figure BDA0002671339460000637
当：
Figure BDA0002671339460000641
则：
D＝D⊥
可以将D的概率分布用于评估属于组S的数据点
Figure BDA0002671339460000642
的概率。
控制
基于在激活超声换能器/超声刀之前、期间或之后测量的数据分类，可以实现多种自动化任务和安全措施。类似地，也可以在一定程度上推断位于端部执行器中的组织的状态以及超声刀的温度，并将它们用于更好地向用户通知超声装置的状态或保护关键结构等。在提交于2018年3月8日的共同拥有的美国临时专利申请号62/640,417(其标题为“TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR”，其以引用方式全文并入本文)中描述了超声刀的温度控制。
类似地，当超声刀极有可能正在接触夹持臂垫时(例如，它们之间没有组织)，或者如果超声刀有可能已经断裂或超声刀有可能接触金属(例如，钉)，则可以减少功率递送。此外，如果钳口闭合并且在超声刀和夹持臂垫之间没有检测到任何组织，则不允许反向切割。
整合其他数据以改进分类
可以将该系统与传感器、用户、患者指标、环境因素等提供的其他信息结合使用，方式是通过使用概率函数和卡尔曼滤波器将来自该过程的数据与上述数据进行组合。给定不同置信度的大量不确定测量结果，卡尔曼滤波器确定状态或状况发生的最大可能性。由于该方法允许将概率指定给新分类的数据点，因此该算法的信息可以利用卡尔曼滤波器中的其他测量值或评估值来实现。
图21为根据本公开的至少一个方面的描绘基于复阻抗特征图案(指纹)来确定钳口状况的控制程序或逻辑配置的逻辑流程图132044。在基于复阻抗特征图案(指纹)确定钳口状况之前，用参考复阻抗特征图案或表征各种钳口状况的训练数据集(S)(包括但不限于如图82中所示的空气132032、夹持臂垫132034、油鞣革132036、钉132038、断裂的刀132040，以及多种组织类型和状况)填充数据库。可将油鞣革(干燥或湿润、全字节或末端)用于表征不同类型的组织。如下获得用于生成参考复阻抗特征图案或训练数据集(S)的数据点：通过向超声换能器施加子治疗驱动信号，扫描从谐振以下到谐振以上的在预定范围频率内的驱动频率，测量在每个频率下的复阻抗并记录数据点。然后使用多种数值方法(包括多项式曲线拟合、傅立叶级数和/或参数方程)将数据点拟合为曲线。本文描述了拟合为参考复阻抗特征图案或训练数据集(S)的参数傅里叶级数。
一旦生成参考复阻抗特征图案或训练数据集(S)，超声器械就测量新的数据点，对新的点进行分类，并确定是否应将新的数据点添加到参考复阻抗特征图案或训练数据集(S)。
现在转到图21的逻辑流程图，在一个方面，控制电路测量132046超声换能器的复阻抗，其中复阻抗被定义为
Figure BDA0002671339460000651
控制电路接收132048复阻抗测量数据点，并将该复阻抗测量数据点与参考复阻抗特征图案中的数据点进行比较132050。控制电路基于比较分析的结果对该复阻抗测量数据点进行分类132052，并且基于比较分析的结果指定132054端部执行器的状态或状况。
在一个方面，控制电路从联接到处理器的数据库或存储器接收参考复阻抗特征图案。在一个方面，控制电路按如下生成参考复阻抗特征图案。联接到控制电路的驱动电路向超声换能器施加非治疗驱动信号，该非治疗驱动信号以初始频率开始，以最终频率结束，并且处于初始频率与最终频率之间的多个频率。控制电路测量在每个频率下的超声换能器的阻抗，并存储与每个阻抗测量值相对应的数据点。控制电路曲线拟合多个数据点，以生成表示参考复阻抗特征图案的三维曲线，其中幅值|Z|和相位
Figure BDA0002671339460000652
被绘制为频率f的函数。曲线拟合包括多项式曲线拟合、傅立叶级数和/或参数方程。
在一个方面，控制电路接收新的阻抗测量数据点，并使用从该新的阻抗测量数据点到已拟合为参考复阻抗特征图案的轨迹的欧几里得垂直距离来对该新的阻抗测量数据点进行分类。控制电路评估对新的阻抗测量数据点进行正确分类的概率。控制电路基于所评估的对新的阻抗测量数据点进行正确分类的概率将新的阻抗测量数据点添加到参考复阻抗特征图案。在一个方面，控制电路基于训练数据集(S)对数据进行分类，其中训练数据集(S)包括多个复阻抗测量数据，并且曲线使用参数傅里叶级数来拟合训练数据集(S)，其中S在本文定义，并且其中将概率分布用于评估属于组S的新的阻抗测量数据点的概率。
基于模型的钳口分类器状态
人们已经对将位于超声装置的钳口内的物质(包括组织的类型和状况)进行分类产生了兴趣。在各个方面，可以表明利用高数据采样和精细图案识别，这种分类是可能的。该方法基于作为频率的函数的阻抗(其中幅值、相位和频率以3D绘制，图案看起来像图19和图20中所示的带)以及图21的逻辑流程图。本公开提供了基于针对压电换能器的成熟模型的替代智能刀算法方法。
举例来说，已知等效电集总参数模型是物理压电换能器的精确模型。它基于机械谐振附近切线的Mittag-Leffler展开。当复阻抗或复导纳被绘制为虚分量与实分量之间的关系时，形成圆。图22为根据本公开的至少一个方面的被绘制为压电振动器的虚分量与实分量之间的关系的复阻抗的圆图132056。图23为根据本公开的至少一个方面的被绘制为压电振动器的虚分量与实分量之间的关系的复导纳的圆图132058。图22和图23中描绘的圆取自IEEE 177标准，该标准全文以引用方式并入本文。表1-4取自IEEE177标准，并且为了完整起见在本文公开。
当扫描从谐振以下到谐振以上的频率时，形成圆。并非以3D方式拉伸圆，而是识别圆并评估圆的半径(r)和偏移(a，b)。然后将这些值与给定状况下的既定值进行比较。这些状况可能是：1)钳口打开且无任何东西，2)末端咬合，3)钳口完全咬合且有钉。如果扫描生成多个谐振，则每个谐振将存在不同特征的圆。如果谐振分开，则每个圆将在下一个圆之前被绘制出来。并非用一系列近似值拟合3D曲线，而是用圆拟合数据。可以使用处理器来计算半径(r)和偏移(a，b)，该处理器被编程为执行下述多种数学或数字技术。可通过捕获圆的图像来评估这些值，并且使用图像处理技术来评估定义圆的半径(r)和偏移(a，b)。
图24为下文指定的集总参数输入和输出的55.5kHz超声压电换能器的复导纳的圆图132060。将集总参数模型的值用于生成复导纳。在模型中施加中等负载。在MathCad中生成的所得导纳圆示于图24中。当扫描从54kHz到58kHz的频率时，形成圆图132060。
集总参数输入值为：
Co＝3.0nF
Cs＝8.22pF
Ls＝1.0H
Rs＝450Ω
基于输入的模型输出为：
Figure BDA0002671339460000671
Figure BDA0002671339460000672
Figure BDA0002671339460000673
将输出值用于绘制示于图24中的圆图132060。圆图132060具有半径(r)，并且中心132062从原点132064偏移(a，b)，如下所示：
r＝1.012*103
a＝1.013*103
b＝-954.585
根据本公开的至少一个方面，需要下面指定的总和A-E来评估图24中给出的示例的圆图132060图。存在若干算法来计算对圆的拟合。圆由其半径(r)和距原点的中心偏移(a，b)定义：
r2＝(x-a)2+(y-b)2
修改后的最小二乘法(Umbach和Jones)很方便，因为对于a、b和r存在简单的封闭形式解决方案。
Figure BDA0002671339460000674
Figure BDA0002671339460000681
Figure BDA0002671339460000682
变量“a”上的插入符号表示对真实值的评估。A、B、C、D和E是根据数据计算出的各种乘积的总和。为了完整起见，将它们包括在本文中，如下所示：
Figure BDA0002671339460000683
Figure BDA0002671339460000684
Figure BDA0002671339460000685
Figure BDA0002671339460000686
Figure BDA0002671339460000687
Z1,i为实分量的第一矢量，称为电导；
Z2,i为虚分量的第二矢量，称为电纳；并且
Z3,i为第三矢量，表示计算导纳的频率。
本公开将适用于超声系统并且可能应用于电外科系统，即使电外科系统不依赖于谐振。
图25至图29示出了从阻抗分析仪获取的图像，该图像示出了端部执行器钳口处于各种打开或闭合构型和具有负载的超声装置的阻抗/导纳圆图。根据本公开的至少一个方面，实线形式的圆图描绘了阻抗，而虚线形式的圆图描绘了导纳。举例来说，通过将超声装置连接到阻抗分析仪来生成阻抗/导纳圆图。将阻抗分析仪的显示设定为复阻抗和复导纳，这可以从阻抗分析仪的前面板中选择。例如，如下文结合图25所述，可在超声端部执行器的钳口处于打开位置并且超声装置处于无负载状态的情况下获得初始显示。阻抗分析仪的自动缩放显示功能可用于生成复阻抗和导纳圆图。同一显示器用于具有不同负载状况的超声装置的后续运行，如后续图25至图29中所示。可使用LabVIEW应用程序上载数据文件。在另一种技术中，可利用照相机诸如智能手机照相机(像iPhone或Android)来捕获显示图像。这样，显示器的图像可能包括一些“梯形失真”，并且通常可能看起来不平行于屏幕。使用该技术，显示器上的圆图痕迹将在捕获的图像中看起来失真。利用该方法，可以对位于超声端部执行器的钳口中的材料进行分类。
复阻抗和复导纳就是彼此的倒数。不能通过观察两者来添加任何新信息。另一个考虑因素包括确定使用复阻抗或复导纳时评估对噪声的敏感程度。
在图25至图29所示的示例中，阻抗分析仪的范围被设置为仅捕获主谐振。通过在更宽范围的频率内进行扫描，可能会遇到更多谐振，并且可形成多个圆图。可通过具有串联连接的电感Ls、电阻Rs和电容Cs(它们定义谐振器的机电特性)的第一“动态”分支以及具有静态电容C0的第二电容分支来对超声换能器的等效电路进行建模。在接下来的图25至图29中所示的阻抗/导纳图中，等效电路的分量的值为：
Ls＝L1＝1.1068HRs＝R1＝311.352ΩCs＝C1＝7.43265pFC0＝C0＝3.64026nF[0245]
Rs＝R1＝311.352ΩCs＝C1＝7.43265pFC0＝C0＝3.64026nF[0245]
Cs＝C1＝7.43265pFC0＝C0＝3.64026nF[0245]
C0＝C0＝3.64026nF[0245]
施加到超声换能器的振荡器电压为500mV，扫描从55kHz到56kHz的频率。阻抗(Z)标度为200Ω/div，并且导纳(Y)标度为500μS/div。可在圆图上由阻抗光标和导纳光标指示的位置处获得可表征阻抗(Z)和导纳(Y)圆图的值的测量结果。
钳口的状态：打开且无负载
图25为根据本公开的至少一个方面的阻抗分析仪的图形显示132066，示出了钳口打开且无负载的超声装置的复阻抗(Z)/导纳(Y)圆图132068、132070，其中实线形式的圆图132068描绘了复阻抗，并且虚线形式的圆图132070描绘了复导纳。施加到超声换能器的振荡器电压为500mV，扫描从55kHz到56kHz的频率。阻抗(Z)标度为200Ω/div，并且导纳(Y)标度为500μS/div。可在圆图132068、132070上由阻抗光标132072和导纳光标132074指示的位置处获得可表征复阻抗(Z)和复导纳(Y)圆图132068、132070的值的测量结果。因此，阻抗光标132072位于阻抗圆图132068的等于约55.55kHz的一部分处，并且导纳光标132074位于导纳圆图132070的等于约55.29kHz的一部分处。如图25中所描绘，阻抗光标132072的位置对应于以下值：
R＝1.66026ΩX＝-697.309Ω[0247]
X＝-697.309Ω[0247]
其中R为电阻(实值)，并且X为电抗(虚值)。类似地，导纳光标132074的位置对应于以下值：
G＝64.0322μSB＝1.63007mS
B＝1.63007mS
其中G为电导(实值)，并且B为电纳(虚值)。
钳口的状态：被夹持在干燥油鞣革上
图26为根据本公开的至少一个方面的阻抗分析仪的图形显示132076，示出了端部执行器的钳口被夹持在干燥油鞣革上的超声装置的复阻抗(Z)/导纳(Y)圆图132078、132080，其中阻抗圆图132078以实线示出，并且导纳圆图132080以虚线示出。施加到超声换能器的电压为500mV，扫描从55kHz到56kHz的频率。阻抗(Z)标度为200Ω/div，并且导纳(Y)标度为500μS/div。
可在圆图132078、132080上由阻抗光标132082和导纳光标132084指示的位置处获得可表征复阻抗(Z)和复导纳(Y)圆图132078、132080的值的测量结果。因此，阻抗光标132082位于阻抗圆图132078的等于约55.68kHz的一部分处，并且导纳光标132084位于导纳圆图132080的等于约55.29kHz的一部分处。如图26中所描绘，阻抗光标132082的位置对应于以下值：
R＝434.577ΩX＝-758.772Ω其中
X＝-758.772Ω其中
其中R为电阻(实值)，并且X为电抗(虚值)。
类似地，导纳光标132084的位置对应于以下值：
G＝85.1712μS
B＝1.49569mS
其中G为电导(实值)，并且B为电纳(虚值)。
钳口的状态：末端被夹持在潮湿油鞣革上
图27为根据本公开的至少一个方面的阻抗分析仪的图形显示132086，示出了钳口末端被夹持在潮湿油鞣革上的超声装置的复阻抗(Z)/导纳(Y)圆图132098、132090，其中阻抗圆图132088以实线示出，并且导纳圆图132090以虚线示出。施加到超声换能器的电压为500mV，扫描从55kHz到56kHz的频率。阻抗(Z)标度为200Ω/div，并且导纳(Y)标度为500μS/div。
可在圆图132088、132090上由阻抗光标132092和导纳光标132094指示的位置处获得可表征复阻抗(Z)和复导纳(Y)圆图132088、132090的值的测量结果。因此，阻抗光标132092位于阻抗圆图132088的等于约55.68kHz的一部分处，并且导纳光标132094位于导纳圆图132090的等于约55.29kHz的一部分处。如图28中所描绘，阻抗光标132092对应于以下值：
R＝445.259ΩX＝-750.082Ω[0253]
X＝-750.082Ω[0253]
其中R为电阻(实值)，并且X为电抗(虚值)。类似地，导纳光标132094对应于以下值：
G＝96.2179μSB＝1.50236mS
B＝1.50236mS
其中G为电导(实值)，并且B为电纳(虚值)。
钳口的状态：被完全夹持在潮湿油鞣革上
图28为根据本公开的至少一个方面的阻抗分析仪的图形显示132096，示出了钳口被完全夹持在潮湿油鞣革上的超声装置的复阻抗(Z)/导纳(Y)圆图132098、132100，其中阻抗圆图132098以实线示出，并且导纳圆图132100以虚线示出。施加到超声换能器的电压为500mV，扫描从55kHz到56kHz的频率。阻抗(Z)标度为200Ω/div，并且导纳(Y)标度为500μS/div。
可在圆图132098、1332100上由阻抗光标13212和导纳光标132104指示的位置处获得可表征阻抗和导纳圆图132098、132100的值的测量结果。因此，阻抗光标132102位于阻抗圆图132098的等于约55.63kHz的一部分处，并且导纳光标132104位于导纳圆图132100的等于约55.29kHz的一部分处。如图28中所描绘，阻抗光标132102对应于电阻R的值(实值，未示出)和电抗X的值(虚值，也未示出)。
类似地，导纳光标132104对应于以下值：
G＝137.272μSB＝1.48481mS
B＝1.48481mS
其中G为电导(实值)，并且B为电纳(虚值)。
钳口的状态：打开且无负载
图29为根据本公开的至少一个方面的阻抗分析仪的图形显示132106，示出了阻抗(Z)/导纳(Y)圆图，其中扫描从48kHz到62kHz的频率，以捕获钳口打开且无负载的超声装置的多个谐振，其中由虚线所示的矩形132108表示的区域是为了有助于看到以实线示出的阻抗圆图132110a、132110b、132110c以及导纳圆图132112a、132112b、132112c。施加到超声换能器的电压为500mV，并且扫描从48kHz到62kHz的频率。阻抗(Z)标度为500Ω/div，并且导纳(Y)标度为500μS/div。
可在阻抗和导纳圆图132110a-c、132112a-c上由阻抗光标132114和导纳光标132116指示的位置处获得可表征阻抗和导纳圆图132110a-c、132112a-c的值的测量结果。因此，阻抗光标132114位于阻抗圆图132110a-c的等于约55.52kHz的一部分处，并且导纳光标132116位于导纳圆图132112a-c的等于约59.55kHz的一部分处。如图29中所描绘，阻抗光标132114对应于以下值：
R＝1.86163kΩX＝-536.229Ω其中
X＝-536.229Ω其中
其中R为电阻(实值)，并且X为电抗(虚值)。类似地，导纳光标132116对应于以下值：
G＝649.956μSB＝2.51975mS
B＝2.51975mS
其中G为电导(实值)，并且B为电纳(虚值)。
因为在阻抗分析仪的整个扫描范围内只有400个样本，所以只有几个关于谐振的点。因此，右侧的圆变得不规则。但这仅仅是因为阻抗分析仪和用于覆盖多个谐振的设定。
当存在多个谐振时，有更多信息可用于改进分类器。可以针对遇到的每个谐振计算圆图132110a-c、132112a-c拟合，以保持算法快速运行。因此，一旦在扫描期间存在复导纳的交点(表示圆)，就可以计算拟合。
益处包括基于数据的钳口中分类器和超声系统的熟知模型。圆的计数和特征在视觉系统中是众所周知的。因此，容易进行数据处理。例如，存在一种封闭形式的解决方案，可以计算圆的半径和轴偏移。该技术可能相对较快。
表2为用于压电换能器的集总参数模型的符号列表(来自IEEE 177标准)。
Figure BDA0002671339460000741
Figure BDA0002671339460000751
表3是传输网络的符号列表(来自IEEE 177标准)。
Figure BDA0002671339460000752
Figure BDA0002671339460000761
*是指实根；忽略复根。
表3
表4是各种特征频率的解决方案列表(来自IEEE 177标准)。
各种特征频率的解决方案
Figure BDA0002671339460000762
Figure BDA0002671339460000771
*是指实根；忽略复根
表4
表5是三类压电材料的损耗。
Figure BDA0002671339460000772
针对各种类型的压电振动器所期望的比率Qr/r的最小值
表5
表6示出了钳口状况，基于对由测得的变量Re、Ge、Xe、Be表示的圆复阻抗/导纳、半径(re)和偏移(ae和be)的实时测量的圆的估计参数，以及
基于对由参考变量Rref、Gref、Xref、Bref表示的参考圆复阻抗/导纳、半径(rr)和偏移(ar、br)的实时测量的参考圆图的参数，如图25至图29所述。然后将这些值与给定状况下的既定值进行比较。这些状况可能是：1)钳口打开且无任何东西，2)末端咬合，3)钳口完全咬合且有钉。按如下对超声换能器的等效电路进行建模，并且扫描从55kHz到56kHz的频率：
Ls＝L1＝1.1068H
Rs＝R1＝311.352Ω
Cs＝C1＝7.43265pF，并且
C0＝C0＝3.64026nF
Figure BDA0002671339460000773
Figure BDA0002671339460000781
表6
在使用中，超声发生器扫描频率，记录测量的变量，并确定评估值Re、Ge、Xe、Be。然后将这些评估值与存储在存储器中(例如，存储在查询表中)的参考变量Rref、Gref、Xref、Bref进行比较，并确定钳口状况。表6中所示的参考钳口状况仅仅是示例。可对更多或更少的参考钳口状况进行分类并将其存储在存储器中。可以将这些变量用于评估阻抗/导纳圆的半径和偏移。
图30为根据本公开的至少一个方面的描绘基于阻抗/导纳圆的半径(r)和偏移(a,b)的评估值来确定钳口状况的控制程序或逻辑配置的过程的逻辑流程图132120。最初，基于如结合图25至图29和表6所述的参考钳口状况用参考值填充数据库或查找表。设定参考钳口状况，并且扫描从谐振以下到谐振以上的值的频率。将定义对应的阻抗/导纳圆图的参考值Rref、Gref、Xref、Bref存储在数据库或查找表中。在使用期间，在控制程序或逻辑配置的控制下，发生器或器械的控制电路使从谐振以下到谐振以上扫描132122频率。控制电路测量并记录132124定义对应的阻抗/导纳圆图的变量Re、Ge、Xe、Be(例如，将它们存储在存储器中)，并将它们与存储在数据库或查找表中的参考值Rref、Gref、Xref、Bref进行比较132126。控制电路基于比较结果确定132128(例如，评估)端部执行器钳口状况。
使用电参数的活时组织分类
密封而不切割、RF/超声组合技术、定制算法
在一个方面，本公开提供了一种用于将组织分类成组的算法。可以使用以下技术来确定132152组织类型：在图19-图21中描述的标题为“ESTIMATING THE STATE OF THEJAW(PAD BURN THROUGH,STAPLES,BROKEN BLADE,BONE IN JAW,TISSUE IN JAW)”和/或在图22-30中描述的标题为“STATE OF JAW CLASSIFIER BASED ON MODEL”的技术，和/或在授予Nott等人的标题为“TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROLSYSTEM THEREFOR”的相关美国临时专利申请号62/640,417中描述的用于估计超声刀的温度的技术，该临时专利申请全文以引用方式并入本文。在存活时间内对组织进行分类的能力将允许针对特定组织组定制算法。所定制的算法可以优化所有组织类型的密封时间和止血效果。在一个方面，本公开提供了一种密封算法，以提供大血管所需的止血效果并快速密封不需要延长的能量激活的较小结构。对这些不同的组织类型进行分类的能力允许在存活时间内针对每个组使用所优化算法。
在这方面，在激活的最初0.75秒内，在图中使用了3个RF电参数将组织分类成不同的组。这些电参数为：初始RF阻抗(在0.15秒时测量)、在最初0.75秒内的最小RF阻抗以及RF阻抗斜率约为0毫秒的时间量。可以实现测量这些数据点的多个其他时间。所有这些数据都将在设定时间量内收集，然后使用支持向量机(SVM)或另一种分类算法在存活时间内将组织分类成不同的组。每个组织组将具有特定于它的算法，该算法将在激活的其余时间内实现。SVM的类型包括线性、多项式和径向基函数(RBF)。
图31为根据本公开的至少一个方面的射频(RF)组织阻抗分类的三维图形表示132450。x轴表示组织的最小RF阻抗(Z最小)，y轴表示组织的初始RF阻抗(Z最初)，并且z轴表示组织的RF阻抗的导数(Z)近似为0的时间量。图31示出了当使用初始RF阻抗、最小RF阻抗和RF阻抗的导数(斜率)在激活的前0.75秒内近似为零的时间量这三个RF参数时，大血管132452(例如颈动脉-厚组织)和小血管132454(例如甲状腺-薄组织)的分组。该分类方法的区别在于，可在设定的时间量内对组织类型进行分类。该方法的优点是可以在激活开始时选择组织特定算法，因此可以在退出RF浴缸之前开始特定的组织治疗。应当理解，组织阻抗在RF能量的影响下，浴缸区域是一条曲线，其中组织阻抗在初始施加RF能量之后下降并且稳定直到组织开始变干。此后，组织阻抗增加。因此，阻抗对时间曲线类似于“浴缸”的形状。
该数据用于训练和测试支持向量机，以对厚组织和薄组织进行分组，并在94％的时间内准确分类。
在一个方面，本公开提供了一种包括用于所有组织类型的组合RF/超声算法的装置，并且已确定薄组织的密封速度比所需的更长，然而，较大的血管和较厚的结构可以受益于延长的激活。该分类方案将使组合RF/超声装置能够以最佳速度和爆裂压力密封小结构，并密封大结构以确保实现最大止血效果。
图32为根据本公开的至少一个方面的射频(RF)组织阻抗分析的三维图形表示132460。x轴表示组织的最小RF阻抗(Z最小)，y轴表示组织的初始RF阻抗(Z最初)，并且z轴表示组织的RF阻抗的导数(Z)近似为0的时间量。为了确定厚组织132462与薄组织132464的分类模型对于不同的组织类型是否可靠，添加了多种台式组织类型的数据，并将该组织分成两个不同的组。如果认为有益或必要，则可以将该数据分成多个组。不同的厚组织132462类型包括例如颈动脉、空肠、肠系膜、颈静脉和肝组织。不同的薄组织132464类型包括例如甲状腺和甲状腺静脉。
用于组织分类的精细解剖模式
组织分类以针对不同的外科技术启用多种模式
在一个方面，本公开提供了一种用于将组织分类成组并且定制算法以在存活时间内对特定组织类别进行分类的算法。可以使用以下技术来确定132152组织类型：在图19-图21中描述的标题为“ESTIMATING THE STATE OF THE JAW(PAD BURN THROUGH,STAPLES,BROKEN BLADE,BONE IN JAW,TISSUE IN JAW)”和/或在图22-30中描述的标题为“STATE OFJAW CLASSIFIER BASED ON MODEL”的技术，和/或在授予Nott等人的标题为“TEMPERATURECONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR”的相关美国临时专利申请号62/640,417中描述的用于估计超声刀的温度的技术，该临时专利申请全文以引用方式并入本文。本公开建立在如本文先前在标题“LIVE TIME TISSUE CLASSIFICATION USINGELECTRICAL PARAMETERS”下所讨论的如图31至图32所公开的对组织进行分类的另一潜在益处的基础和细节上。
图33为根据本公开的至少一个方面的颈动脉技术敏感性的图形表示132470，其中将RF阻抗(Z)导数近似为0的时间绘制为初始RF阻抗的函数。已知在世界不同地区存在不同的外科技术，并且这些外科技术在外科医生之间差异很大。因此，可在发生器上设置一种技术模式，以基于使用者的特定外科技术(例如末端咬合组织对完全咬合组织)实现更有效的能量递送。末端咬合是指仅在末端处抓持组织的外科装置的端部执行器。完全咬合是指将组织抓持在外科器械的整个端部执行器内的端部执行器。发生器可被配置成能够检测使用者是否一直在末端咬合组织或完全咬合组织的情况下进行操作。如图33所示，测量了初始RF阻抗数据，并绘制了末端咬合作为组1 132472和完全咬合作为组2 132474。如图所示，组1132472末端咬合组织记录的初始RF阻抗Z初始小于250欧姆，并且组2132474完全咬合组织记录的初始阻抗Z初始在250欧姆和500欧姆之间，最大RF组织阻抗Z最大。在检测到使用者是抓持末端咬合组织或完全咬合组织时，该算法可以建议预定的解剖模式。例如，对于末端咬合组织，该算法可以向使用者建议精细解剖模式，或者可以在手术之前选择该选项。例如，对于完全咬合组织，该算法可以向使用者建议粗解剖模式，或者可以在手术之前选择该选项。在精细解剖模式下，可定制算法以通过降低超声位移来优化用于该外科技术的能量递送，以保护夹持臂垫免于烧穿。还已知末端咬合具有更大的RF噪声量，导致更长的密封时间，以及密封性能的更大变化。末端咬合的精细解剖模式可以具有被定制为具有较低的RF终端阻抗和/或不同的滤波信号以提高能量递送的准确性的算法。
作为分类开发工作的一部分，进行了技术敏感性分析。通过使用不同的外科技术在台式设置中横切3mm-7mm血管进行测试，诸如在有张力和无张力的情况下的完全咬合横切，以及在有张力和无张力的情况下的末端咬合横切。最初RF阻抗和RF阻抗的斜率＝0的时间都被作为将组织分类成组的重要因素。
已确定可以基于初始RF阻抗Z初始将外科技术分成3个不同的组。通常在0-100欧姆之间的范围内的初始RF阻抗Z初始表示在出血区中操作。通常在100-300欧姆之间的范围内的初始RF阻抗Z初始表示在正常条件下操作，而大于300欧姆的初始RF阻抗Z初始则表示滥用条件，尤其是在存在张力的情况下。
尽管已举例说明和描述了多个形式，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。在不脱离本公开的范围的情况下，可实现对这些形式的许多修改、变化、改变、替换、组合和等同物，并且本领域技术人员将想到这些形式的许多修改、变化、改变、替换、组合和等同物。此外，另选地，可将与所描述的形式相关联的每个元件的结构描述为用于提供由所述元件执行的功能的器件。另外，在公开了用于某些部件的材料的情况下，也可使用其他材料。因此，应当理解，上述具体实施方式和所附权利要求旨在涵盖属于本发明所公开的形式范围内的所有此类修改形式、组合和变型形式。所附权利要求旨在涵盖所有此类修改、变化、改变、替换、修改和等同物。
上述具体实施方式已经由使用框图、流程图和/或示例阐述了装置和/或方法的各种形式。只要此类框图、流程图和/或示例包含一个或多个功能和/或操作，本领域的技术人员就要将其理解为此类框图、流程图和/或示例中的每个功能和/或操作都可以单独和/或共同地通过多种硬件、软件、固件或实际上它们的任何组合来实施。本领域的技术人员将会认识到，本文公开的形式中的一些方面可作为在一台或多台计算机上运行的一个或多个计算机程序(如，作为在一个或多个计算机系统上运行的一个或多个程序)，作为在一个或多个处理器上运行的一个或多个程序(如，作为在一个或多个微处理器上运行的一个或多个程序)，作为固件，或作为实际上它们的任何组合全部或部分地在集成电路中等效地实现，并且根据本发明，设计电子电路和/或编写软件和/或硬件的代码将在本领域技术人员的技术范围内。另外，本领域的技术人员将会认识到，本文所述主题的机制能够作为多种形式的一个或多个程序产品进行分布，并且本文所述主题的示例性形式适用，而不管用于实际进行分布的信号承载介质的具体类型是什么。
用于编程逻辑以执行各种所公开的方面的指令可存储在系统内的存储器内，诸如动态随机存取存储器(DRAM)、高速缓存、闪存存储器或其他存储器。此外，指令可经由网络或通过其他计算机可读介质来分发。因此，机器可读介质可包括用于存储或传输以机器(例如，计算机)可读形式的信息的机构，但不限于软盘、光学盘、光盘、只读存储器(CD-ROM)、磁光盘、只读存储器(ROM)、随机存取存储器(RAM)、可擦除可编程只读存储器(EPROM)、电可擦除可编程只读存储器(EEPROM)、磁卡或光卡、闪存存储器、或经由电信号、光学信号、声学信号或其他形式的传播信号(例如，载波、红外信号、数字信号等)在因特网上传输信息时使用的有形的、机器可读存储装置。因此，非暂态计算机可读介质包括适于以机器(例如，计算机)可读的形式存储或传输电子指令或信息的任何类型的有形机器可读介质。
如本文任一方面所用，术语“控制电路”可指例如硬连线电路系统、可编程电路系统(例如，计算机处理器，该计算机处理器包括一个或多个单独指令处理内核、处理单元，处理器、微控制器、微控制器单元、控制器、数字信号处理器(DSP)、可编程逻辑装置(PLD)、可编程逻辑阵列(PLA)、场可编程门阵列(FPGA))、状态机电路系统、存储由可编程电路系统执行的指令的固件、以及它们的任何组合。控制电路可以集体地或单独地实现为形成更大系统的一部分的电路系统，例如集成电路(IC)、专用集成电路(ASIC)、片上系统(SoC)、台式计算机、膝上型计算机、平板计算机、服务器、智能电话等。因此，如本文所用，“控制电路”包括但不限于具有至少一个离散电路的电子电路、具有至少一个集成电路的电子电路、具有至少一个专用集成电路的电子电路、形成由计算机程序配置的通用计算设备的电子电路(如，至少部分地实施本文所述的方法和/或设备的由计算机程序配置的通用计算机，或至少部分地实施本文所述的方法和/或设备的由计算机程序配置的微处理器)、形成存储器设备(如，形成随机存取存储器)的电子电路，和/或形成通信设备(如，调节解调器、通信开关或光电设备)的电子电路。本领域的技术人员将会认识到，可以模拟或数字方式或它们的一些组合实施本文所述的主题。
如本文的任何方面所用，术语“逻辑”可指被配置成能够执行前述操作中的任一者的应用程序、软件、固件和/或电路系统。软件可体现为记录在非暂态计算机可读存储介质上的软件包、代码、指令、指令集和/或数据。固件可体现为在存储器装置中硬编码(例如，非易失性)的代码、指令或指令集和/或数据。
如本文任一方面所用，术语“部件”、“系统”、“模块”等可指计算机相关实体、硬件、硬件和软件的组合、软件或执行中的软件。
如本文任一方面中所用，“算法”是指导致所期望结果的有条理的步骤序列，其中“步骤”是指物理量和/或逻辑状态的操纵，物理量和/或逻辑状态可(但不一定)采用能被存储、转移、组合、比较和以其他方式操纵的电或磁信号的形式。常用于指这些信号，如位、值、元素、符号、字符、术语、数字等。这些和类似的术语可与适当的物理量相关联并且仅仅是应用于这些量和/或状态的方便的标签。
网络可包括分组交换网络。通信装置可能够使用所选择的分组交换网络通信协议来彼此通信。一个示例性通信协议可包括可允许使用传输控制协议/因特网协议(TCP/IP)进行通信的以太网通信协议。以太网协议可符合或兼容电气和电子工程师学会(IEEE)于2008年12月发布的标题为“IEEE802.3Standard”的以太网标准和/或本标准的更高版本。另选地或附加地，通信装置可能够使用X.25通信协议彼此通信。X.25通信协议可符合或符合国际电信联盟电信标准化部门(ITU-T)颁布的标准。另选地或附加地，通信装置可能够使用帧中继通信协议彼此通信。帧中继通信协议可符合或符合国际电话和电话协商委员会(CCITT)和/或美国国家标准学会(ANSI)发布的标准。另选地或附加地，收发器可能够使用异步传输模式(ATM)通信协议彼此通信。ATM通信协议可符合或兼容ATM论坛于2001年8月发布的名为“ATM-MPLS Network Interworking 2.0”的ATM标准和/或该标准的更高版本。当然，本文同样设想了不同的和/或之后开发的连接取向的网络通信协议。
除非上述公开中另外明确指明，否则可以理解的是，在上述公开中，使用术语如“处理”、“估算”、“计算”、“确定”、“显示”的讨论是指计算机系统或类似的电子计算装置的动作和进程，其操纵表示为计算机系统的寄存器和存储器内的物理(电子)量的数据并将其转换成相似地表示为计算机系统存储器或寄存器或其他此类信息存储、传输或显示装置内的物理量的其他数据。
一个或多个部件在本文中可被称为“被配置成能够”、“可配置成能够”、“可操作/可操作地”、“适于/可适于”、“能够”、“可适形/适形于”等。本领域的技术人员将会认识到，除非上下文另有所指，否则“被配置成能够”通常可涵盖活动状态的部件和/或未活动状态的部件和/或待机状态的部件。
术语“近侧”和“远侧”在本文中是相对于操纵外科器械的柄部部分的临床医生来使用的。术语“近侧”是指最靠近临床医生的部分，术语“远侧”是指远离临床医生定位的部分。还应当理解，为简洁和清楚起见，本文可结合附图使用诸如“竖直”、“水平”、“上”和“下”等空间术语。然而，外科器械在许多方向和位置中使用，并且这些术语并非限制性的和/或绝对的。
本领域的技术人员将认识到，一般而言，本文、以及特别是所附权利要求(例如，所附权利要求的正文)中所使用的术语通常旨在为“开放”术语(例如，术语“包括”应解释为“包括但不限于”，术语“具有”应解释为“至少具有”，术语“包含”应解释为“包含但不限于”等)。本领域的技术人员还应当理解，如果所引入权利要求叙述的具体数目为预期的，则这样的意图将在权利要求中明确叙述，并且在不存在这样的叙述的情况下，不存在这样的意图。例如，为有助于理解，下述所附权利要求可含有对介绍性短语“至少一个”和“一个或多个”的使用以引入权利要求。然而，对此类短语的使用不应视为暗示通过不定冠词“一个”或“一种”引入权利要求表述将含有此类引入权利要求表述的任何特定权利要求限制在含有仅一个这样的表述的权利要求中，甚至当同一权利要求包括介绍性短语“一个或多个”或“至少一个”和诸如“一个”或“一种”(例如，“一个”和/或“一种”通常应解释为意指“至少一个”或“一个或多个”)的不定冠词时；这也适用于对用于引入权利要求表述的定冠词的使用。
另外，即使明确叙述引入权利要求叙述的特定数目，本领域的技术人员应当认识到，此种叙述通常应解释为意指至少所叙述的数目(例如，在没有其他修饰语的情况下，对“两个叙述”的裸叙述通常意指至少两个叙述、或两个或更多个叙述)。此外，在其中使用类似于“A、B和C中的至少一者等”的惯例的那些情况下，一般而言，此类构造意在具有本领域的技术人员将理解所述惯例的意义(例如，“具有A、B和C中的至少一者的系统”将包括但不限于具有仅A、仅B、仅C、A和B一起、A和C一起、B和C一起和/或A、B和C一起等的系统)。在其中使用类似于“A、B或C中的至少一者等”的惯例的那些情况下，一般而言，此类构造意在具有本领域的技术人员将理解所述惯例的意义(例如，“具有A、B或C中的至少一者的系统”应当包括但不限于具有仅A、仅B、仅C、A和B一起、A和C一起、B和C一起和/或A、B和C一起等的系统)。本领域的技术人员还应当理解，通常，除非上下文另有指示，否则无论在具体实施方式、权利要求或附图中呈现两个或更多个替代术语的转折性词语和/或短语应理解为涵盖包括所述术语中的一者、所述术语中的任一个或这两个术语的可能性。例如，短语“A或B”通常将被理解为包括“A”或“B”或“A和B”的可能性。
对于所附的权利要求，本领域的技术人员将会理解，其中表述的操作通常可以任何顺序进行。另外，尽管以一个或多个序列出了各种操作流程图，但应当理解，可以不同于所示顺序的其他顺序执行各种操作，或者可同时执行所述各种操作。除非上下文另有规定，否则此类替代排序的示例可包括重叠、交错、中断、重新排序、增量、预备、补充、同时、反向，或其他改变的排序。此外，除非上下文另有规定，否则像“响应于”、“相关”这样的术语或其他过去式的形容词通常不旨在排除此类变体。
值得一提的是，任何对“一个方面”、“一方面”、“一范例”、“一个范例”的提及均意指结合所述方面所述的具体特征部、结构或特征包括在至少一个方面中。因此，在整个说明书的各种位置出现的短语“在一个方面”、“在一方面”、“在一范例中”、“在一个范例中”不一定都指同一方面。此外，具体特征部、结构或特征可在一个或多个方面中以任何合适的方式组合。
本说明书提及和/或在任何申请数据表中列出的任何专利申请，专利，非专利公布或其他公开材料均以引用方式并入本文，只要所并入的材料在此不一致。因此，并且在必要的程度下，本文明确列出的公开内容代替以引用方式并入本文的任何冲突材料。据称以引用方式并入本文但与本文列出的现有定义、陈述或其他公开材料相冲突的任何材料或其部分，将仅在所并入的材料和现有的公开材料之间不产生冲突的程度下并入。
概括地说，已经描述了由采用本文所述的概念产生的许多有益效果。为了举例说明和描述的目的，已经提供了一个或多个形式的上述具体实施方式。这些具体实施方式并非意图为详尽的或限定到本发明所公开的精确形式。可以按照上述教导内容对本发明进行修改或变型。选择和描述的一个或多个形式是为了说明原理和实际应用，从而使本领域的普通技术人员能够利用适用于预期的特定用途的各种形式和各种修改形式。与此一同提交的权利要求书旨在限定完整范围。
本文所述主题的各个方面在以下编号的实施例中陈述：
实施例1.一种基于外科技术控制向射频(RF)器械施加能量的方法，所述方法包括：由处理器或控制电路激活所述射频(RF)器械持续第一时间段T1，其中所述RF器械的端部执行器的一部分在至少所述第一时间段T1内接触组织；由所述处理器或所述控制电路绘制与跟所述RF器械接触的所述组织相关联的至少两个电参数以对所述端部执行器的与所述组织接触的量进行分类；由所述处理器或所述控制电路应用分类算法以对所述端部执行器的与所述组织接触的所述量进行分类；以及由所述处理器或所述控制电路基于所述端部执行器的与所述组织接触的所述量向所述端部执行器施加一定量的能量。
实施例2.根据实施例1所述的方法，其中，由所述处理器或所述控制电路绘制与跟所述RF器械接触的所述组织相关联的至少两个电参数包括：由所述处理器或所述控制电路绘制所述组织的最小RF阻抗，和RF阻抗斜率约为0时的以毫秒为单位的时间量。
实施例3.根据实施例1至2中任一项或多项所述的方法，还包括由所述处理器或所述控制电路在预定时间量内收集与所述至少两个电参数相关联的数据。
实施例4.根据实施例3所述的方法，其中，由所述处理器或所述控制电路在预定时间量内收集与所述至少两个电参数相关联的数据包括：由所述处理器或所述控制电路在激活所述射频(RF)器械之后的最初0.75秒内收集与所述至少两个电参数相关联的数据。
实施例5.根据实施例1至4中任一项或多项所述的方法，其中，由所述处理器或所述控制电路应用分类算法以对所述端部执行器的与所述组织接触的所述量进行分类包括：由所述处理器或所述控制电路应用分类算法以使用支持向量机算法对所述端部执行器的与所述组织接触的所述量进行分类。
实施例6.根据实施例5所述的方法，其中，由所述处理器或所述控制电路应用分类算法以使用支持向量机算法对所述端部执行器的与所述组织接触的所述量进行分类包括：由所述处理器或所述控制电路应用分类算法以使用线性基函数、多项式基函数或径向基函数对所述端部执行器的与所述组织接触的所述量进行分类。
实施例7.根据实施例1至6中任一项或多项所述的方法，还包括由所述处理器或所述控制电路在所述第一时间段T1之后应用特定于所述端部执行器的与所述组织接触的所述量的激活算法。
实施例8.根据实施例1至7中任一项或多项所述的方法，其中，由所述处理器或所述控制电路应用分类算法以对所述端部执行器的与所述组织接触的所述量进行分类包括：由所述处理器或所述控制电路应用分类算法以对所述端部执行器的与所述组织接触的所述量进行分类，其中所述分类包括第一组或第二组，所述第一组包括所述端部执行器的末端端部与所述组织接触，所述第二组包括所述端部执行器的整个表面与所述组织接触。
实施例9.一种外科器械，包括：具有端部执行器的射频(RF)器械；以及发生器，所述发生器被配置成能够向所述端部执行器供应功率，其中所述发生器包括控制电路，所述控制电路被配置成能够：激活所述射频(RF)器械持续第一时间段T1，其中所述端部执行器的一部分在至少所述第一时间段T1内接触组织；绘制与跟所述RF器械接触的所述组织相关联的至少两个电参数以对所述端部执行器的与所述组织接触的量进行分类；应用分类算法以对所述端部执行器的与所述组织接触的所述量进行分类；以及基于所述端部执行器的与所述组织接触的所述量向所述端部执行器施加一定量的能量。
实施例10.根据实施例9所述的外科器械，其中，与跟所述RF器械接触的所述组织相关联的所述至少两个电参数包括所述组织的初始RF阻抗和RF阻抗斜率约为0时的以毫秒为单位的时间量。
实施例11.根据实施例9至10中任一项或多项所述的外科器械，其中，所述控制电路还被配置成能够在预定时间量内收集与所述至少两个电参数相关联的数据。
实施例12.根据实施例11所述的外科器械，其中，所述预定时间量包括在激活所述射频(RF)器械之后的最初0.75秒。
实施例13.根据实施例9至12中任一项或多项所述的外科器械，其中，所述控制电路还被配置成能够使用支持向量机算法对所述端部执行器的与所述组织接触的所述量进行分类。
实施例14.根据实施例13所述的外科器械，其中，所述支持向量机算法包括线性基函数、多项式基函数或径向基函数。
实施例15.根据实施例9至14中任一项或多项所述的外科器械，其中，所述控制电路还被配置成能够在所述第一时间段T1之后应用特定于所述端部执行器的与所述组织接触的所述量的激活算法。
实施例16.根据实施例9至15中任一项或多项所述的方法，其中，所述分类算法被配置成能够将所述端部执行器的与所述组织接触的所述量分类为第一组或第二组，在所述第一组中，所述端部执行器的末端端部接触所述组织，在所述第二组中，所述端部执行器的整个表面接触所述组织。
实施例17.一种用于外科器械的发生器，其中，所述外科器械包括具有端部执行器的射频(RF)器械，所述发生器包括：控制电路，所述控制电路被配置成能够：激活所述射频(RF)器械持续第一时间段T1，其中所述端部执行器的一部分在至少所述第一时间段T1内接触组织；绘制与跟所述RF器械接触的所述组织相关联的至少两个电参数以对所述端部执行器的与所述组织接触的量进行分类；应用分类算法以对所述端部执行器的与所述组织接触的所述量进行分类；以及基于所述端部执行器的与所述组织接触的所述量向所述端部执行器施加一定量的能量。
实施例18.根据实施例17所述的用于外科器械的发生器，其中，与跟所述RF器械接触的所述组织相关联的所述至少两个电参数包括所述组织的初始RF阻抗和RF阻抗斜率约为0时的以毫秒为单位的时间量。
实施例19.根据实施例17至18中任一项或多项所述的用于外科器械的发生器，其中，所述控制电路还被配置成能够在预定时间量内收集与所述至少两个电参数相关联的数据。
实施例20.根据实施例19所述的用于外科器械的发生器，其中，所述预定时间量包括在激活所述射频(RF)器械之后的最初0.75秒。
实施例21.根据实施例17至20中任一项或多项所述的用于外科器械的发生器，其中，所述控制电路还被配置成能够使用支持向量机算法对所述端部执行器的与所述组织接触的所述量进行分类。
实施例22.根据实施例21所述的用于外科器械的发生器，其中，所述支持向量机算法包括线性基函数、多项式基函数或径向基函数。
实施例23.根据实施例17至22中任一项或多项所述的用于外科器械的发生器，其中，所述控制电路还被配置成能够在所述第一时间段T1之后应用特定于所述端部执行器的与所述组织接触的所述量的激活算法。
实施例24.根据实施例17至23中任一项或多项所述的方法，其中，所述分类算法被配置成能够将所述端部执行器的与所述组织接触的所述量分类为第一组或第二组，在所述第一组中，所述端部执行器的末端端部接触所述组织，在所述第二组中，所述端部执行器的整个表面接触所述组织。

Claims (24)

1.一种基于外科技术控制向射频(RF)器械施加能量的方法，所述方法包括：
由处理器或控制电路激活所述射频(RF)器械持续第一时间段T1，其中所述RF器械的端部执行器的一部分在至少所述第一时间段T1内接触组织；
由所述处理器或所述控制电路绘制与跟所述RF器械接触的所述组织相关联的至少两个电参数以对所述端部执行器的与所述组织接触的量进行分类；
由所述处理器或所述控制电路应用分类算法以对所述端部执行器的与所述组织接触的所述量进行分类；以及
由所述处理器或所述控制电路基于所述端部执行器的与所述组织接触的所述量向所述端部执行器施加一定量的能量。
2.根据权利要求1所述的方法，其中，由所述处理器或所述控制电路绘制与跟所述RF器械接触的所述组织相关联的至少两个电参数包括：由所述处理器或所述控制电路绘制所述组织的最小RF阻抗，以及RF阻抗斜率约为0时的以毫秒为单位的时间量。
3.根据权利要求1所述的方法，还包括由所述处理器或所述控制电路在预定时间量内收集与所述至少两个电参数相关联的数据。
4.根据权利要求3所述的方法，其中，由所述处理器或所述控制电路在预定时间量内收集与所述至少两个电参数相关联的数据包括：由所述处理器或所述控制电路在激活所述射频(RF)器械之后的最初0.75秒内收集与所述至少两个电参数相关联的数据。
5.根据权利要求1所述的方法，其中，由所述处理器或所述控制电路应用分类算法以对所述端部执行器的与所述组织接触的所述量进行分类包括：由所述处理器或所述控制电路应用分类算法以使用支持向量机算法对所述端部执行器的与所述组织接触的所述量进行分类。
6.根据权利要求5所述的方法，其中，由所述处理器或所述控制电路应用分类算法以使用支持向量机算法对所述端部执行器的与所述组织接触的所述量进行分类包括：由所述处理器或所述控制电路应用分类算法以使用线性基函数、多项式基函数或径向基函数对所述端部执行器的与所述组织接触的所述量进行分类。
7.根据权利要求1所述的方法，还包括由所述处理器或所述控制电路在所述第一时间段T1之后应用特定于所述端部执行器的与所述组织接触的所述量的激活算法。
8.根据权利要求1所述的方法，其中，由所述处理器或所述控制电路应用分类算法以对所述端部执行器的与所述组织接触的所述量进行分类包括：由所述处理器或所述控制电路应用分类算法以对所述端部执行器的与所述组织接触的所述量进行分类，其中所述分类包括第一组或第二组，所述第一组包括所述端部执行器的末端端部与所述组织接触，所述第二组包括所述端部执行器的整个表面与所述组织接触。
9.一种外科器械，包括：
射频(RF)器械，所述射频(RF)器械包括端部执行器；以及
发生器，所述发生器被配置成能够向所述端部执行器供应功率，其中所述发生器包括控制电路，所述控制电路被配置成能够：
激活所述射频(RF)器械持续第一时间段T1，其中所述端部执行器的一部分在至少所述第一时间段T1内接触组织；
绘制与跟所述RF器械接触的所述组织相关联的至少两个电参数以对所述端部执行器的与所述组织接触的量进行分类；
应用分类算法以对所述端部执行器的与所述组织接触的所述量进行分类；并且
基于所述端部执行器的与所述组织接触的所述量向所述端部执行器施加一定量的能量。
10.根据权利要求9所述的外科器械，其中，与跟所述RF器械接触的所述组织相关联的所述至少两个电参数包括所述组织的初始RF阻抗和RF阻抗斜率约为0时的以毫秒为单位的时间量。
11.根据权利要求9所述的外科器械，其中，所述控制电路还被配置成能够在预定时间量内收集与所述至少两个电参数相关联的数据。
12.根据权利要求11所述的外科器械，其中，所述预定时间量包括激活所述射频(RF)器械之后的最初0.75秒。
13.根据权利要求9所述的外科器械，其中，所述控制电路还被配置成能够使用支持向量机算法对所述端部执行器的与所述组织接触的所述量进行分类。
14.根据权利要求13所述的外科器械，其中，所述支持向量机算法包括线性基函数、多项式基函数或径向基函数。
15.根据权利要求9所述的外科器械，其中，所述控制电路还被配置成能够在所述第一时间段T1之后应用特定于所述端部执行器的与所述组织接触的所述量的激活算法。
16.根据权利要求9所述的方法，其中，所述分类算法被配置成能够将所述端部执行器的与所述组织接触的所述量分类为第一组或第二组，在所述第一组中，所述端部执行器的末端端部接触所述组织，在所述第二组中，所述端部执行器的整个表面接触所述组织。
17.一种用于外科器械的发生器，其中，所述外科器械包括具有端部执行器的射频(RF)器械，所述发生器包括：
控制电路，所述控制电路被配置成能够：
激活所述射频(RF)器械持续第一时间段T1，其中所述端部执行器的一部分在至少所述第一时间段T1内接触组织；
绘制与跟所述RF器械接触的所述组织相关联的至少两个电参数以对所述端部执行器的与所述组织接触的量进行分类；
应用分类算法以对所述端部执行器的与所述组织接触的所述量进行分类；并且
基于所述端部执行器的与所述组织接触的所述量向所述端部执行器施加一定量的能量。
18.根据权利要求17所述的用于外科器械的发生器，其中，与跟所述RF器械接触的所述组织相关联的所述至少两个电参数包括所述组织的初始RF阻抗和RF阻抗斜率约为0时的以毫秒为单位的时间量。
19.根据权利要求17所述的用于外科器械的发生器，其中，所述控制电路还被配置成能够在预定时间量内收集与所述至少两个电参数相关联的数据。
20.根据权利要求19所述的用于外科器械的发生器，其中，所述预定时间量包括在激活所述射频(RF)器械之后的最初0.75秒。
21.根据权利要求17所述的用于外科器械的发生器，其中，所述控制电路还被配置成能够使用支持向量机算法对所述端部执行器的与所述组织接触的所述量进行分类。
22.根据权利要求21所述的用于外科器械的发生器，其中，所述支持向量机算法包括线性基函数、多项式基函数或径向基函数。
23.根据权利要求17所述的用于外科器械的发生器，其中，所述控制电路还被配置成能够在所述第一时间段T1之后应用特定于所述端部执行器的与所述组织接触的所述量的激活算法。
24.根据权利要求17所述的方法，其中，所述分类算法被配置成能够将所述端部执行器的与所述组织接触的所述量分类为第一组或第二组，在所述第一组中，所述端部执行器的末端端部接触所述组织，在所述第二组中，所述端部执行器的整个表面接触所述组织。
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