CN111836592A - 具有温度控制的超声密封算法 - Google Patents

具有温度控制的超声密封算法 Download PDF

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Publication number
CN111836592A
CN111836592A CN201980018051.8A CN201980018051A CN111836592A CN 111836592 A CN111836592 A CN 111836592A CN 201980018051 A CN201980018051 A CN 201980018051A CN 111836592 A CN111836592 A CN 111836592A
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Prior art keywords
ultrasonic
resonant frequency
generator
temperature
predetermined
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CN201980018051.8A
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Inventor
K·G·登津格
C·R·诺特
M·C·杰梅
P·J·斯科金斯
C·N·法勒
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Ethicon LLC
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Ethicon LLC
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Abstract

本发明公开了一种进行超声密封的方法,该方法包括:激活超声刀温度感测;测量超声机电系统的第一谐振频率,所述超声机电系统包括经由波导联接到刀的换能器;在所测量的第一谐振频率和第一预定谐振频率之间进行第一比较;以及基于第一比较来调节施加到换能器的功率水平。第一预定频率可对应于最佳组织凝结温度。该方法还可包括:测量所述系统的第二谐振频率;在测量的第二频率和第二预定频率之间进行第二比较;以及基于第二比较来调节功率水平。第二预定频率可对应于夹持臂垫的熔点温度。本发明还公开了可实施所述方法的超声器械和发生器。

Description

具有温度控制的超声密封算法
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“ULTRASONIC SEALING ALGORITHM WITHTEMPERATURE CONTROL”的美国非临时专利申请序列号16/144,345的权益,该申请的公开内容全文以引用方式并入本文。
本申请还要求2018年3月8日提交的标题为“TEMPERATURE CONTROL INULTRASONIC DEVICE 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 ANDCONTROL SYSTEM THEREFOR”的美国临时专利申请序列号62/640,415的权益,这些申请中的每个申请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,因其独特的性能特性而用于外科规程的多种应用中。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结止血,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,刀尖端)以切割和密封组织。在一些情况下,器械可永久性地附连到手持件。在其它情况下,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发射到与端部执行器接触的组织,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规程,包括机器人辅助的规程。
超声能量使用低于电外科规程中所用的温度来切割并凝结组织,并且可通过与手持件连通的超声发生器将超声能量发射到端部执行器。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,以形成粘性凝结物。刀表面施加在组织上的压力使血管塌缩并使该凝结物形成止血密封。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结。
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阻抗图以改善发生器的频率锁定能力。然而,调谐电感器必须与超声换能器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,发生器的驱动信号表现出非对称谐波失真,这使阻抗量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规程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以包括可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通信的发生器发射至器械。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导致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,则双极技术可使用较低频率。通常,不使用高于5MHz的频率以最小化与高频泄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发射低频RF能量,这会引起离子振荡或摩擦,并实际上造成电阻性加热,从而升高组织的温度。由于可在受影响的组织与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联接,尤其是在使用较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为与超声器械一起使用,而另一个用户界面可被配置为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种方面,因此还设想了被配置为与超声和/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它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。
其它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
在利用温度控制进行超声密封的方法的一个方面,该方法包括:激活超声刀温度感测;测量超声机电系统的第一谐振频率,其中超声机电系统包括经由超声波导联接到超声刀的超声换能器;在第一预定谐振频率对应于超声刀的第一预定温度的条件下在所测量的第一谐振频率和第一预定谐振频率之间进行第一比较;以及基于第一比较来调节施加到超声换能器的功率水平。
在该方法的一个方面,在第一预定谐振频率对应于第一预定温度的条件下在所测量的第一谐振频率和第一预定谐振频率之间进行第一比较,可包括:在第一预定谐振频率对应于最佳组织凝结温度的条件下在所测量的第一谐振频率和第一预定谐振频率之间进行第一比较。
在一个方面,该方法还可包括确定组织密封过程的完成。
在一个方面,该方法还可包括:测量超声机电系统的第二谐振频率;在第二预定谐振频率对应于超声刀的第二预定温度的条件下在所测量的第二谐振频率和第二预定谐振频率之间进行第二比较;以及基于第二比较来调节施加到超声换能器的功率水平。
在该方法的一个方面,在第二预定谐振频率对应于第二预定温度的条件下在所测量的第二谐振频率和第二预定谐振频率之间进行第二比较,可包括:在第二预定谐振频率对应于夹持臂垫的熔点温度的条件下在所测量的第二谐振频率和第二预定谐振频率之间进行第二比较。
在一个方面,该方法还可包括提高施加到超声换能器的功率水平,直到超声密封完成。
在一个方面,超声外科器械可包括:超声机电系统,所述超声机电系统由经由超声波导联接到超声刀的超声换能器构成;夹持臂垫;以及发生器。发生器可被配置为向超声换能器供应功率,并且发生器可包括控制电路,所述控制电路被配置为:激活超声刀温度感测;测量超声机电系统的第一谐振频率;在第一预定谐振频率对应于超声刀的第一预定温度的条件下在所测量的第一谐振频率和第一预定谐振频率之间进行第一比较;以及基于该比较来调节施加到超声换能器的功率水平。
在该超声外科器械的一个方面,超声刀的第一预定温度可对应于最佳组织凝结温度。
在该超声外科器械的一个方面,控制电路还被配置为确定组织密封过程的完成。
在该超声外科器械的一个方面,控制电路还可被配置为:测量超声机电系统的第二谐振频率;在第二预定谐振频率对应于超声刀的第二预定温度的条件下在所测量的谐振频率和第二预定谐振频率之间进行第二比较;以及基于第二比较来调节施加到超声换能器的功率水平。
在该超声外科器械的一个方面,超声刀的第二预定温度可对应于夹持臂垫的熔点。
在该超声外科器械的一个方面,控制电路还可被配置为提高施加到超声换能器的功率水平,直到超声密封完成。
在一个方面,用于超声外科器械的发生器可包括控制电路,所述控制电路被配置为:激活超声刀温度感测;测量超声机电系统的第一谐振频率;在第一预定谐振频率对应于超声刀的第一预定温度的条件下在所测量的第一谐振频率和第一预定谐振频率之间进行第一比较;以及基于第一比较来调节施加到超声换能器的功率水平。
在该发生器的一个方面,超声刀的第一预定温度可对应于最佳组织凝结温度。
在该发生器的一个方面,控制电路还被配置为确定组织密封过程的完成。
在该发生器的一个方面,控制电路还可被配置为:测量超声机电系统的第二谐振频率;在第二预定谐振频率对应于超声刀的第二预定温度的条件下在所测量的第二谐振频率和第二预定谐振频率之间进行第二比较;以及基于第二比较来调节施加到超声换能器的功率水平。
在该发生器的一个方面,超声刀的第二预定温度可对应于夹持臂垫的熔点。
在该发生器的一个方面,控制电路还被配置为提高施加到超声换能器的功率水平,直到超声密封完成。
在一个方面,超声外科系统可包括处理器和非暂态存储器,其中非暂态存储器包含指令,所述指令在由处理器执行时致使处理器:激活超声刀温度感测;测量超声机电系统的第一谐振频率;在第一预定谐振频率对应于超声刀的第一预定温度的条件下在所测量的第一谐振频率和第一预定谐振频率之间进行第一比较;基于第一比较来调节施加到超声换能器的功率水平;测量超声机电系统的第二谐振频率;在第二预定谐振频率对应于超声刀的第二预定温度的条件下在所测量的第二谐振频率与第二预定谐振频率之间进行比较;以及基于第二比较来调节施加到超声换能器的功率水平。
附图说明
各种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所述多个方面(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为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可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-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-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为控制外科器械或工具的各个方面的控制电路。
图11示出了根据本公开的至少一个方面的被配置为控制外科器械或工具的各个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为控制外科器械或工具的各个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电路被配置为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电路被配置为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的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检测其阻抗的替代系统。
图19A-19B为根据本公开的至少一个方面的具有冷和热超声刀的相同超声装置的复阻抗光谱,其中
图19A为作为具有冷(实线)和热(虚线)超声刀的相同超声装置的谐振频率的函数的阻抗相位角的图形表示;并且
图19B为作为具有冷(实线)和热(虚线)超声刀的相同超声装置的谐振频率的函数的阻抗量值的图形表示。
图20为根据本公开的至少一个方面的基于在多种频率处测量的超声换能器上的阻抗来改善温度估计器和状态空间模型的卡尔曼滤波器的图示。
图21为根据本公开的至少一个方面的图20中所示的卡尔曼滤波器的状态估计器用来最大化估计的三种概率分布。
图22A为在没有温度控制的情况下达到490℃的最高温度的超声装置的温度与时间的关系图形表示。
图22B为根据本公开的至少一个方面的在具有温度控制的情况下达到320℃的最高温度的超声装置的温度与时间关系的图形表示。
图23为根据本公开的至少一个方面的实现大约340℃的温度所需的初始频率与频率变化之间的关系的图形表示。
图24示出了根据本公开的至少一个方面的反馈控制系统,该反馈控制系统包括超声发生器以调整施加到超声机电系统的超声换能器的电流(i)设定点,以防止超声换能器的频率(f)降低到低于预定阈值。
图25为示出根据本公开的至少一个方面的过程的逻辑流程图,该逻辑流程图描绘了用于保护端部执行器垫的受控热管理方法的控制程序或逻辑配置。
图26为根据本公开的至少一个方面的温度对时间的图形表示,该图形表示比较了超声刀与智能超声刀和常规超声刀的期望温度。
图27为根据本公开的至少一个方面的描绘提供具有温度控制的超声密封的控制程序或逻辑配置的过程的逻辑流程图。
图28描绘了根据本公开的至少一个方面的作为时间的函数的超声换能器电流和超声刀温度的图形表示。
具体实施方式
本专利申请的申请人还拥有以下同时提交的美国专利申请,这些申请中的每个申请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“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以下同时提交的美国专利申请,这些申请中的每个申请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;
·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;以及
·标题为“FINE DISSECTION MODE FOR TISSUE CLASSIFICATION”,代理人案卷号为END8536USNP13/180107-13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,这些申请中的每个申请的公开内容全文以引用方式并入本文:
·标题为“AUTOMATED DATA SCALING,ALIGNMENT,AND ORGANIZING BASED ONPREDEFINED PARAMETERS WITHIN A SURGICAL NETWORK BEFORE TRANSMISSION”的美国临时专利申请序列号62/729,177;
·标题为“SENSING THE PATIENT POSITION AND CONTACT UTILIZING THE MONO-POLAR RETURN PAD ELECTRODE TO PROVIDE SITUATIONAL AWARENESS TO THE HUB”的美国临时专利申请序列号62/729,182;
·标题为“POWERED SURGICAL TOOL WITH A PREDEFINED ADJUSTABLE CONTROLALGORITHM FOR CONTROLLING AT LEAST ONE END-EFFECTOR PARAMETER AND A MEANS FORLIMITING THE ADJUSTMENT”的美国临时专利申请序列号62/729,184;
·标题为“SURGICAL NETWORK RECOMMENDATIONS FROM REAL TIME ANALYSIS OFPROCEDURE VARIABLES AGAINST A BASELINE HIGHLIGHTING DIFFERENCES FROM THEOPTIMAL SOLUTION”的美国临时专利申请序列号62/729,183;
·标题为“A CONTROL FOR A SURGICAL NETWORK OR SURGICAL NETWORKCONNECTED DEVICE THAT ADJUSTS ITS FUNCTION BASED ON A SENSED SITUATION ORUSAGE”的美国临时专利申请序列号62/729,191;
·标题为“INDIRECT COMMAND AND CONTROL OF A FIRST OPERATING ROOMSYSTEM THROUGH THE USE OF A SECOND OPERATING ROOM SYSTEM WITHIN A STERILEFIELD WHERE THE SECOND OPERATING ROOM SYSTEM HAS PRIMARY AND SECONDARYOPERATING MODES”的美国临时专利申请序列号62/729,176;
·标题为“WIRELESS PAIRING OF A SURGICAL DEVICE WITH ANOTHER DEVICEWITHIN A STERILE SURGICAL FIELD BASED ON THE USAGE AND SITUATIONAL AWARENESSOF DEVICES”的美国临时专利申请序列号62/729,186;以及
·标题为“POWERED STAPLING DEVICE THAT IS CAPABLE OF ADJUSTING FORCE,ADVANCEMENT SPEED,AND OVERALL STROKE OF CUTTING MEMBER OF THE DEVICE BASED ONSENSED PARAMETER OF FIRING OR CLAMPING”的美国临时专利申请序列号62/729,185。
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,这些申请中的每个申请的公开内容全文以引用方式并入本文:
·标题为“ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROLSYSTEM THEREFOR”的美国专利申请序列号16/115,214;
·标题为“TEMPERATURE CONTROL OF ULTRASONIC END EFFECTOR AND CONTROLSYSTEM THEREFOR”的美国专利申请序列号16/115,205;
·标题为“RADIO FREQUENCY ENERGY DEVICE FOR DELIVERING COMBINEDELECTRICAL SIGNALS”的美国专利申请序列号16/115,233;
·标题为“CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TOTISSUE LOCATION”的美国专利申请序列号16/115,208;
·标题为“CONTROLLING ACTIVATION OF AN ULTRASONIC SURGICAL INSTRUMENTACCORDING TO THE PRESENCE OF TISSUE”的美国专利申请序列号16/115,220;
·标题为“DETERMINING TISSUE COMPOSITION VIA AN ULTRASONIC SYSTEM”的美国专利申请序列号16/115,232;
·标题为“DETERMINING THE STATE OF AN ULTRASONIC ELECTROMECHANICALSYSTEM ACCORDING TO FREQUENCY SHIFT”的美国专利申请序列号16/115,239;
·标题为“DETERMINING THE STATE OF AN ULTRASONIC END EFFECTOR”的美国专利申请序列号16/115,247;
·标题为“SITUATIONAL AWARENESS OF ELECTROSURGICAL SYSTEMS”的美国专利申请序列号16/115,211;
·标题为“MECHANISMS FOR CONTROLLING DIFFERENT ELECTROMECHANICALSYSTEMS OF AN ELECTROSURGICAL INSTRUMENT”的美国专利申请序列号16/115,226;
·标题为“DETECTION OF END EFFECTOR EMERSION IN LIQUID”的美国专利申请序列号16/115,240;
·标题为“INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACITIVECOUPLING”的美国专利申请序列号16/115,249;
·标题为“INCREASING RADIO FREQUENCY TO CREATE PAD-LESS MONOPOLARLOOP”的美国专利申请序列号16/115,256;
·标题为“BIPOLAR COMBINATION DEVICE THAT AUTOMATICALLY ADJUSTSPRESSURE BASED ON ENERGY MODALITY”的美国专利申请序列号16/115,223;以及
·标题为“ACTIVATION OF ENERGY DEVICES”的美国专利申请序列号16/115,238。
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,这些申请中的每个申请的公开内容全文以引用方式并入本文:
·标题为“CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TOTISSUE LOCATION”的美国临时专利申请62/721,995;
·标题为“SITUATIONAL AWARENESS OF ELECTROSURGICAL SYSTEMS”的美国临时专利申请62/721,998;
·标题为“INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACITIVECOUPLING”的美国临时专利申请62/721,999;
·标题为“BIPOLAR COMBINATION DEVICE THAT AUTOMATICALLY ADJUSTSPRESSURE BASED ON ENERGY MODALITY”的美国临时专利申请62/721,994;以及
·标题为“RADIO FREQUENCY ENERGY DEVICE FOR DELIVERING COMBINEDELECTRICAL SIGNALS”的美国临时专利申请62/721,996。
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,这些申请中的每个申请的公开内容全文以引用方式并入本文:
·标题为“SMART ACTIVATION OF AN ENERGY DEVICE BY ANOTHER DEVICE”的美国临时专利申请62/692,747;
·标题为“SMART ENERGY ARCHITECTURE”的美国临时专利申请62/692,748;以及
·标题为“SMART ENERGY DEVICES”的美国临时专利申请62/692,768。
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,这些申请中的每个申请的公开内容全文以引用方式并入本文:
·标题为“CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAYELEMENTS”的美国专利申请序列号16/024,090;
·标题为“CONTROLLING A SURGICAL INSTRUMENT ACCORDING TO SENSEDCLOSURE PARAMETERS”的美国专利申请序列号16/024,057;
·标题为“SYSTEMS FOR ADJUSTING END EFFECTOR PARAMETERS BASED ONPERIOPERATIVE INFORMATION”的美国专利申请序列号16/024,067;
·标题为“SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING”的美国专利申请序列号16/024,075;
·标题为“SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING”的美国专利申请序列号16/024,083;
·标题为“SURGICAL SYSTEMS FOR DETECTING END EFFECTOR TISSUEDISTRIBUTION IRREGULARITIES”的美国专利申请序列号16/024,094;
·标题为“SYSTEMS FOR DETECTING PROXIMITY OF SURGICAL END EFFECTOR TOCANCEROUS TISSUE”的美国专利申请序列号16/024,138;
·标题为“SURGICAL INSTRUMENT CARTRIDGE SENSOR ASSEMBLIES”的美国专利申请序列号16/024,150;
·标题为“VARIABLE OUTPUT CARTRIDGE SENSOR ASSEMBLY”的美国专利申请序列号16/024,160;
·标题为“SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE”的美国专利申请序列号16/024,124;
·标题为“SURGICAL INSTRUMENT HAVING A FLEXIBLE CIRCUIT”的美国专利申请序列号16/024,132;
·标题为“SURGICAL INSTRUMENT WITH A TISSUE MARKING ASSEMBLY”的美国专利申请序列号16/024,141;
·标题为“SURGICAL SYSTEMS WITH PRIORITIZED DATA TRANSMISSIONCAPABILITIES”的美国专利申请序列号16/024,162;
·标题为“SURGICAL EVACUATION SENSING AND MOTOR CONTROL”的美国专利申请序列号16/024,066;
·标题为“SURGICAL EVACUATION SENSOR ARRANGEMENTS”的美国专利申请序列号16/024,096;
·标题为“SURGICAL EVACUATION FLOW PATHS”的美国专利申请序列号16/024,116;
·标题为“SURGICAL EVACUATION SENSING AND GENERATOR CONTROL”的美国专利申请序列号16/024,149;
·标题为“SURGICAL EVACUATION SENSING AND DISPLAY”的美国专利申请序列号16/024,180;
·标题为“COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUBOR CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM”的美国专利申请序列号16/024,245;
·标题为“SMOKE EVACUATION SYSTEM INCLUDING A SEGMENTED CONTROLCIRCUIT FOR INTERACTIVE SURGICAL PLATFORM”的美国专利申请序列号16/024,258;
·标题为“SURGICAL EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FORCOMMUNICATION BETWEEN A FILTER AND A SMOKE EVACUATION DEVICE”的美国专利申请序列号16/024,265;以及
·标题为“DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS”的美国专利申请序列号16/024,273。
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,这些申请中的每个申请的公开内容全文以引用方式并入本文:
·标题为“A Method of using reinforced flex circuits with multiplesensors with electrosurgical devices”的美国临时专利申请序列号62/691,228;
·标题为“controlling a surgical instrument according to sensedclosure parameters”的美国临时专利申请序列号62/691,227;
·标题为“SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE”的美国临时专利申请序列号62/691,230;
·标题为“SURGICAL EVACUATION SENSING AND MOTOR CONTROL”的美国临时专利申请序列号62/691,219;
·标题为“COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUBOR CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM”的美国临时专利申请序列号62/691,257;
·标题为“SURGICAL EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FORCOMMUNICATION BETWEEN A FILTER AND A SMOKE EVACUATION DEVICE”的美国临时专利申请序列号62/691,262;以及
·标题为“DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS”的美国临时专利申请序列号62/691,251。
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,这些申请中的每个申请的公开内容全文以引用方式并入本文:
·标题为“METHOD OF HUB COMMUNICATION”的美国临时专利申请序列号62/659,900。
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,这些申请中的每个申请的公开内容全文以引用方式并入本文:
·提交于2018年3月30日,标题为“CAPACITIVE COUPLED RETURN PATH PAD WITHSEPARABLE ARRAY ELEMENTS”的美国临时专利申请62/650,898;
·标题为“SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES”的美国临时专利申请序列号62/650,887;
·标题为“SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM”的美国临时专利申请序列号62/650,882;以及
·标题为“SURGICAL SMOKE EVACUATION SENSING AND CONTROLS”的美国临时专利申请序列号62/650,877。
本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,这些申请中的每个申请的公开内容全文以引用方式并入本文:
·标题为“INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATIONCAPABILITIES”的美国专利申请序列号15/940,641;
·标题为“INTERACTIVE SURGICAL SYSTEMS WITH CONDITION HANDLING OFDEVICES AND DATA CAPABILITIES”的美国专利申请序列号15/940,648;
·标题为“SURGICAL HUB COORDINATION OF CONTROL AND COMMUNICATION OFOPERATING ROOM DEVICES”的美国专利申请序列号15/940,656;
·标题为“SPATIAL AWARENESS OF SURGICAL HUBS IN OPERATING ROOMS”的美国专利申请序列号15/940,666;
·标题为“COOPERATIVE UTILIZATION OF DATA DERIVED FROM SECONDARYSOURCES BY INTELLIGENT SURGICAL HUBS”的美国专利申请序列号15/940,670;
·标题为“SURGICAL HUB CONTROL ARRANGEMENTS”的美国专利申请序列号15/940,677;
·标题为“DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS ANDCREATE ANONYMIZED RECORD”的美国专利申请序列号15/940,632;
·标题为“COMMUNICATION HUB AND STORAGE DEVICE FOR STORING PARAMETERSAND STATUS OF A SURGICAL DEVICE TO BE SHARED WITH CLOUD BASED ANALYTICSSYSTEMS”的美国专利申请序列号15/940,640;
·标题为“SELF DESCRIBING DATA PACKETS GENERATED AT AN ISSUINGINSTRUMENT”的美国专利申请序列号15/940,645;
·标题为“DATA PAIRING TO INTERCONNECT A DEVICE MEASURED PARAMETERWITH AN OUTCOME”的美国专利申请序列号15/940,649;
·标题为“SURGICAL HUB SITUATIONAL AWARENESS”的美国专利申请序列号15/940,654;
·标题为“SURGICAL SYSTEM DISTRIBUTED PROCESSING”的美国专利申请序列号15/940,663;
·标题为“AGGREGATION AND REPORTING OF SURGICAL HUB DATA”的美国专利申请序列号15/940,668;
·标题为“SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES INOPERATING THEATER”的美国专利申请序列号15/940,671;
·标题为“DISPLAY OF ALIGNMENT OF STAPLE CARTRIDGE TO PRIOR LINEARSTAPLE LINE”的美国专利申请序列号15/940,686;
·标题为“STERILE FIELD INTERACTIVE CONTROL DISPLAYS”的美国专利申请序列号15/940,700;
·标题为“COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS”的美国专利申请序列号15/940,629;
·标题为“USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TODETERMINE PROPERTIES OF BACK SCATTERED LIGHT”的美国专利申请序列号15/940,704;
·标题为“CHARACTERIZATION OF TISSUE IRREGULARITIES THROUGH THE USE OFMONO-CHROMATIC LIGHT REFRACTIVITY”的美国专利申请序列号15/940,722;以及
·标题为“DUAL CMOS ARRAY IMAGING”的美国专利申请序列号15/940,742。
·标题为“ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES”的美国专利申请序列号15/940,636;
·标题为“ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL HUBS”的美国专利申请序列号15/940,653;
·标题为“CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION ANDRECOMMENDATIONS TO A USER”的美国专利申请序列号15/940,660;
·标题为“CLOUD-BASED MEDICAL ANALYTICS FOR LINKING OF LOCAL USAGETRENDS WITH THE RESOURCE ACQUISITION BEHAVIORS OF LARGER DATA SET”的美国专利申请序列号15/940,679;
·标题为“CLOUD-BASED MEDICAL ANALYTICS FOR MEDICAL FACILITY SEGMENTEDINDIVIDUALIZATION OF INSTRUMENT FUNCTION”的美国专利申请序列号15/940,694;
·标题为“CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY ANDAUTHENTICATION TRENDS AND REACTIVE MEASURES”的美国专利申请序列号15/940,634;
·标题为“DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICSNETWORK”的美国专利申请序列号15/940,706;以及
·标题为“CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES”的美国专利申请序列号15/940,675。
·标题为“DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS”的美国专利申请序列号15/940,627;
·标题为“COMMUNICATION ARRANGEMENTS FOR ROBOT-ASSISTED SURGICALPLATFORMS”的美国专利申请序列号15/940,637;
·标题为“CONTROLS FOR ROBOT-ASSISTED SURGICAL PLATFORMS”的美国专利申请序列号15/940,642;
·标题为“AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICALPLATFORMS”的美国专利申请序列号15/940,676;
·标题为“CONTROLLERS FOR ROBOT-ASSISTED SURGICAL PLATFORMS”的美国专利申请序列号15/940,680;
·标题为“COOPERATIVE SURGICAL ACTIONS FOR ROBOT-ASSISTED SURGICALPLATFORMS”的美国专利申请序列号15/940,683;
·标题为“DISPLAY ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS”的美国专利申请序列号15/940,690;以及
·标题为“SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS”的美国专利申请序列号15/940,711。
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,这些申请中的每个申请的公开内容全文以引用方式并入本文:
·标题为“INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATIONCAPABILITIES”的美国临时专利申请序列号62/649,302;
·标题为“DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS ANDCREATE ANONYMIZED RECORD”的美国临时专利申请序列号62/649,294;
·标题为“SURGICAL HUB SITUATIONAL AWARENESS”的美国临时专利申请序列号62/649,300;
·标题为“SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES INOPERATING THEATER”的美国临时专利申请序列号62/649,309;
·标题为“COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS”的美国临时专利申请序列号62/649,310;
·标题为“USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TODETERMINE PROPERTIES OF BACK SCATTERED LIGHT”的美国临时专利申请序列号62/649,291;
·标题为“ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES”的美国临时专利申请序列号62/649,296;
·标题为“CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION ANDRECOMMENDATIONS TO A USER”的美国临时专利申请序列号62/649,333;
·标题为“CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY ANDAUTHENTICATION TRENDS AND REACTIVE MEASURES”的美国临时专利申请序列号62/649,327;
·标题为“DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICSNETWORK”的美国临时专利申请序列号62/649,315;
·标题为“CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES”的美国临时专利申请序列号62/649,313;
·标题为“DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS”的美国临时专利申请序列号62/649,320;
·标题为“AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICALPLATFORMS”的美国临时专利申请序列号62/649,307;以及
·标题为“SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS”的美国临时专利申请序列号62/649,323。
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,这些申请中的每个申请的公开内容全文以引用方式并入本文:
·标题为“INTERACTIVE SURGICAL PLATFORM”的美国临时专利申请序列号美国临时专利申请序列号62/611,341;
·标题为“CLOUD-BASED MEDICAL ANALYTICS”的美国临时专利申请序列号62/611,340;以及
·标题为“ROBOT ASSISTED SURGICAL PLATFORM”的美国临时专利申请序列号62/611,339。
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方式的细节。示例性示例可以单独实现,或与其它方面、变更形式和修改形式结合在一起实现,并可以通过多种方式实践或执行。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它方面、方面和/或示例的表达中的任何一个或多个组合。
各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规程期间横切和/或凝结组织。电外科装置的各方面可被配置用于例如在外科规程期间横切、凝结、定标、焊接和/或干燥组织。
自适应超声刀控制算法
在各种方面,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为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为将组织类型参数化。本公开的以下区段描述了一种用于检测组织的胶原/弹性比率以调谐超声刀的远侧尖端的振幅的算法。本文结合例如图1-2描述了智能超声能量装置的各方面。因此,以下对自适应超声刀控制算法的描述应当结合图1-2以及与其相关联的描述来阅读。
在某些外科规程中,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,超声刀的远侧尖端的机械位移振幅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率而调谐。可使用多种技术检测胶原与弹性蛋白组织的比率,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为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被配置为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被配置为执行如本文参考图25-34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235两者均被配置为执行如本文参考图13-18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。功率变压器的次级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至不同的外科器械,诸如超声外科器械、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7-12描述了发生器模块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,诸如智能外科器械、机器人和位于手术室中的其它计算机化装置。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为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/或网络交换器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也可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也可联接到网络交换器。网络交换器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也可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“互联网”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“基于互联网的计算的类型”,其中将不同的服务(诸如服务器、存储装置和应用程序)递送至位于外科室(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互联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,云服务提供方可以是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它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还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为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,诸如智能外科器械、机器人和位于手术室中的其它计算机化装置。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:联接到内窥镜的成像模块,联接到能量装置241的发生器模块240,以及任选地联接到显示器237的智能装置/器械235。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/或其它可视化系统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,其为发生器的一种形式,该发生器被配置为联接到超声器械并且还被配置为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被配置为将多个能量模态递送至外科器械。发生器900提供用于独立地或同时将能量递送至外科器械的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被配置为基于存储在联接到处理器902的存储器中的信息来生成各种信号波形,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904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“能量1”和“返回”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“能量2”和“返回”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至n个“能量n”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,可提供多至n个返回路径“返回n”。
第一电压感测电路912联接到被标记为“能量1”和“返回”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“能量2”和“返回”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“返回”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整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920与处理器902电气通信。
在一个方面,阻抗可由处理器902通过将联接在被标记为“能量1”/“返回”的端子两端的第一电压感测电路912或联接在被标记为“能量2”/“返回”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“返回”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“能量1”可为超声能量,并且第二能量模态“能量2”可为RF能量。然而,除了超声和双极或单极RF能量模态之外,其它能量模态还包括不可逆和/或可逆电穿孔和/或微波能量等。而且,虽然图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“返回”,但在其它方面,可为每种能量模态“能量n”提供多个返回路径“返回n”。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可用较高电压和较低电流递送能量以驱动超声换能器,用较低电压和较高电流递送能量以驱动RF电极以用于密封组织,或者用凝结波形递送能量以用于使用单极或双极RF电外科电极进行点凝结。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输出的连接将优选地位于被标记为“能量1”和“返回”的输出之间,如图2中所示。在一个示例中,RF双极电极与发生器900输出的连接将优选地位于被标记为“能量2”和“返回”的输出之间。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)或其它探头)到“能量2”输出的和连接至“返回”输出的合适的返回垫。
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组织不包含任何电线,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和以上的任何其它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较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较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它数据流)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它电子系统的所有部件的集成电路(也被称为“IC”或“芯片”)。它可以包含数字、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可以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它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,诸如由德克萨斯器械公司(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德克萨斯器械公司(Texas Instruments)的LM4F230H5QR ARMCortex-M4F处理器内核,其包括:256KB的单循环闪存或其它非易失性存储器(最多至40MHZ)的片上存储器、用于使性能改善超过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 BDA0002672386690000281
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)、以及易得的其它特征。
在一个方面,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,诸如同样由德克萨斯器械公司(Texas Instruments)提供的商品名为Hercules ARMCortex R4的TMS570和RM4x。安全控制器可被配置为专门用于IEC 61508和ISO 26262安全关键应用等等,以提供先进的集成安全特征件,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收在外科集线器内的模块(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、医疗成像装置、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可被配置用于与多种外科器械一起使用。根据各种形式,发生器1100可为可被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被显示为与外科器械1104、1106、1108分离,然而在一种形式中,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。发生器1100可被配置用于有线或无线通信。
发生器1100被配置为驱动多个外科器械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或其它功能的切换按钮1134a、1134b、1134c的组合。切换按钮1134a、1134b、1134c可以被配置为用发生器1100给超声换能器1120供能。
发生器1100还被配置为驱动第二外科器械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还被配置为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或其它功能的切换按钮1137a、1137b、1137c的组合。切换按钮1137a、1137b、1137c可以被配置为用发生器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可被配置用于与多种外科器械一起使用。根据各种形式,发生器1100可为可被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被显示为与外科器械1104、1106、1108分开,然而在另一种形式中,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。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1128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,并且当与组织接触时,可切割和/或凝结组织,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1140可被配置为与端部执行器1122的刀1128协作行动。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 BDA0002672386690000301
或其它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,可将待夹持的组织咬合可被抓握在组织垫1163与刀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接触或接近刀1128)。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1430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的任意组合(图3)。例如,装置1104可被配置为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设定,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)也可包括一对电极。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、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。在各种方面,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可被配置为生成特定电压、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,凝结、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,用户可使用输入装置2150对发生器1100的操作进行编程或以其它方式进行控制。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。在其它方面,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入装置2140(图8B)。输出装置2140包括用于为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,虽然各种方面可按照模块和/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)可包括作为固件、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。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)(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/或凝结操作模式驱动超声换能器1120。装置1104和/或组织的电特性可被测量并且用于控制发生器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、凝结和/或脱水模式将电能(例如,RF能量)供应至端部执行器1124。装置1106和/或组织的电特性可被测量并且用于控制发生器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,处理器可被配置为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。当超声机电系统处于谐振时,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与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很容易地监测电压Vg(t)信号和电流Ig(t)信号之间的相位差并且可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这样的等效电路,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阻抗图以改善发生器的频率锁定能力。然而,调谐电感器必须与超声换能器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中以虚线显示),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与单个谐振频率下静态电容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它有益效果之外还提供无电感器调谐。图8A-8C示出了根据一个方面的图7的发生器1100的架构。参照图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的次级绕组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,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1060b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的初级绕组1640的输出。在某些方面,功率放大器1620可包括例如推挽式放大器。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1660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。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,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、波形振幅)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/或其它控制算法,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,开关模式调整器1700可包括例如可调式降压调整器。如上所述,非隔离级1540还可包括处理器1740,该处理器1740在一个方面可包括DSP处理器诸如ADSP-21469SHARC DSP,其可得自例如马萨诸塞州诺伍德的模拟装置公司(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可控制开关模式调整器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-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/或振幅。在一个方面,例如,可编程逻辑装置1660可通过检索(recall)存储于动态更新的查找表(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。因为其它频率可激发寄生谐振,因此最小化或降低动态支路电流的总失真可相应地最小化或降低不利的谐振效应。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与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需的波形形状。
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可被配置为以高速(例如,80Msps)进行采样,以实现对驱动信号进行过采样。在一个方面,例如,ADC 1780、1800的采样速度可实现驱动信号的约200X(根据频率而定)的过采样。在某些方面,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,除可实现其它事物之外,还可实现对流过动态支路的复杂电流的计算(这在某些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、以及以高精度计算真实功耗。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样本或以其它方式与对应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/或振幅(例如,电流振幅)。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。随后,可控制驱动信号的频率以最小化或降低所确定阻抗相位与阻抗相位设定点(例如,0°)之间的差值,从而最小化或降低谐波失真的影响,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 BDA0002672386690000381
Figure BDA0002672386690000382
Figure BDA0002672386690000383
Figure BDA0002672386690000384
在正弦频率下评估傅立叶变换得到:
Figure BDA0002672386690000391
Figure BDA0002672386690000392
其它方法包括加权最小二乘估计、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。可通过以下公式计算任何时间点处的相位角
Figure BDA0002672386690000393
Figure BDA0002672386690000394
其中
Figure BDA0002672386690000395
为相位角,f为频率,t为时间,并且
Figure BDA0002672386690000396
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水,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,则可降低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。高精度相位估计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。在其它方面,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它技术包括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振幅保持在电流振幅设定点。电流振幅设定点可被直接指定或基于特定的电压振幅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,比例积分微分(PID)控制算法)来实现对电流振幅的控制。控制算法为了适当控制驱动信号的电流振幅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DAC 1860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可包括例如购自加利福尼亚州圣何塞的阿特梅尔公司(AtmelCorporation,San Jose,Calif.)的具有ARM 926EJ-S核心的Atmel AT91 SAM9263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/或其它输入(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,并且当检测到错误条件时停用发生器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命令处理器1900转变至特定状态时,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进入故障模式。
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/或其它控制器装置。在一个方面,例如,控制器1960可包括处理器(例如,可从Atmel公司(Atemel)购得的Mega168 8位控制器),该处理器被配置为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Atmel公司(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)。控制器1960可因此开始使发生器1100转变至“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转变至“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转变至“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去除功率的独立能力。
在某些方面,控制器1960可使发生器1100提供听觉或其它感观反馈,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它过程开始之前提供此警示。
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)与非隔离级1540的部件(诸如,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之间的合适的电气隔离程度的通信链路(诸如,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可被配置为从可编程逻辑电路2000接收周期性信号(例如,2kHz的方波),以生成具有相同频率的双极询问信号。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,振幅、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,以用于生成由于询问信号通过控制电路而出现在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的其它元件)与设置于外科装置中的或以其它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可与可编程逻辑装置2000分开地实现,并且包括合适的电路系统(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。在其它方面,第一数据电路接口2040可与逻辑装置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/或任何其它类型的信息。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。器械的其它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可被配置为与外科装置的器械(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,然而也可使用其它接口。在某些方面,第二数据电路通常可为用于发射和/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/或任何其它类型的信息。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,第二数据电路可发射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指示或其它可视指示)。
在某些方面,第二数据电路和第二数据电路接口2100可被配置为使得可达成可编程逻辑装置2000与第二数据电路之间的通信而无需为此提供附加的导体(例如,将手持件连接至发生器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发射至手持件中的控制电路的导体中的一者)而将信息发送至第二数据电路并从第二数据电路发送信息。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可包括至少一个阻挡电容器2960-1(图8C),该至少一个阻挡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,可要求信号阻挡电容器符合医疗规则或标准。尽管相对而言单电容器设计中很少出现故障,然而此类故障可造成不良后果。在一个方面,可设置有与阻挡电容器2960-1串联的第二阻挡电容器2960-2,其中通过例如ADC 2980来检测从阻挡电容器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可确定阻挡电容器2960-1、2960-2中的至少一者何时出现故障。因此,图7的方面相对于具有单个故障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-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的次级绕组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允许对驱动信号进行过采样(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-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振幅误差。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振幅样本。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。其它波形形状可为期望的。例如,可以设想可使用用于驱动在其它频率下与一个或多个其它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它模式的有利振动的至少两个机械谐振的三阶谐波。
在块2240确定的样本振幅误差的每个值连同其相关联的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)。基于样本振幅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地址的样本振幅误差的值),LUT 2280(或可编程逻辑装置1660的其它控制块)可预失真或修改存储在LUT地址处的LUT样本的值,使得样本振幅误差降低或最小化。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LUT2260的样本所表示的期望电流波形形状。
电流和电压振幅测量值、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进行处理以去除由例如数据采集过程和感应的谐波分量产生的噪声。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率可用作诊断指示符。
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,负载电阻量值的测量值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、频率锁定故障、过电压条件、过电流条件、过功率条件、电压感测故障、电流感测故障、音频指示故障、视觉指示故障、短路条件、功率递送故障或阻塞电容器故障。
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降低所确定的阻抗相位与阻抗相位设定点(例如,0°)之间的差值,可最小化或降低谐波失真的影响,并且相位测量的准确性增大。
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)进行处理以去除例如数据采集过程和感应的谐波分量所产生的噪声。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的输出可以是动态支路电流样本。
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处确定的阻抗量值,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),以便将在框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,从而提高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振幅的算法,以便根据用户指定的设定点或根据由发生器1100实现的其它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DAC 1680(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大。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处测量的负载阻抗量值Zm给出的期望电压设定点2620B(Vsp)所需的电流间接指定(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)所需的电流间接指定(例如,Id=Psp/Vrms)。
块2680(图9A)可实现DDS控制算法,以用于通过检索存储在LUT 2280中的LUT样本来控制驱动信号。在某些方面,DDS控制算法可以是数字控制振荡器(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LUT2280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,从而导致波形输出复制存储在LUT 2280中的波形。当D>1时,相位累加器可跳过LUT 2280中的地址,从而产生具有较高频率的波形输出。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。最小电压信号可由ADC 1760取样,其中输出最小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,只要最小电压样本的值小于输入到块2720中的最小目标2780,则可根据由最小电压样本表征的波形包络来调制干线电压。例如,当最小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。当最小电压样本落在最小目标2780以下时,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示出了根据本公开的一个方面的被配置为控制外科器械或工具的各个方面的控制电路500。控制电路500可被配置为实现本文所述的各种过程。电路500可以包括微控制器,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执行时致使处理器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为从本公开的存储器电路504接收指令。
图11示出了根据本公开的一个方面的被配置为控制外科器械或工具的各个方面的组合逻辑电路510。组合逻辑电路510可被配置为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512被配置为在输入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为控制外科器械或工具的各个方面的时序逻辑电路520。时序逻辑电路520或组合逻辑522可被配置为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被配置为从输入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。在其它方面,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。在其它实施方案中,有限状态机可以包括组合逻辑电路(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为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、现场可编程门阵列(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电路被配置为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。可以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。
波形信号可被配置为控制超声换能器和/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,波形信号可被配置为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,发生器可被配置为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为控制超声换能器和/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为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为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,并且联接到位于外科系统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(或其它任意波形)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振幅驱动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,该放大器具有联接到发生器电路的输出的输出。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输出频率的较高阶谐波折返回到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,以基于器械设定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结的高波峰因数RF电信号波形、用于较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结的电信号波形。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它因素。在其它方面,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)。在其它方面,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。在其它方面,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、和/或子治疗能量,同时维持超声频率锁定。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“凝结”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(相位到振幅转换器)、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,相位到振幅转换器)。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将存储在并行增量相位寄存器4204中的数字M添加至相位寄存器4208中的数字。假设并行增量相位寄存器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232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提供到相位到振幅转换器查找表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振幅信息。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振幅字,该数字振幅字继而驱动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Ann),其中点n处的归一化振幅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 阶段点数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。可以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的功率放大器放大、或者以RF能量的形式被馈送至组织、或者以超声振动的形式被馈送至组织,该超声振动以热的形式将能量递送至组织。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在其溢出和重新启动之前步进通过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。
对于被配置为累积n位的相为累加器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 BDA0002672386690000561
上述公式被称为DDS“调谐公式”。注意,系统的频率分辨率等于
Figure BDA0002672386690000562
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为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为向至少一个外科器械提供电信号波形,其中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为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为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模式下的表面凝结)、低波峰因数RF信号(其可用于较深的组织渗透)、以及促进有效的触摸凝结的波形。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/或其它因素。
除了传统的正弦/余弦波形状之外,发生器电路还可被配置为产生使每个循环中进入组织的功率最大化的波形状(即,梯形或方波)。发生器电路可提供波形状,该波形状被同步以在同时驱动RF信号和超声信号时使递送至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,以基于器械设定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结的高波峰因数RF电信号波形、用于较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结的电信号波形。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它因素。在其它方面,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)。在其它方面,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。在其它方面,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如是在许多高波峰因数“凝结”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(显示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。通过存储振幅相位点4302来生成数字电信号波形4300,该振幅相位点4302表示一个循环或周期To上每个时钟循环Tclk的振幅。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。振幅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位的分辨率存储振幅相位点的六位字。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上的数字振幅相位点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依次读取振幅相位点4302,并且由DAC电路4108、4212转换,也结合图13、图14所述。可通过将数字电信号波形4300的振幅相位点4302从0至To反复读取尽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。将经滤波的模拟输出信号4114、4222(图13和14)施加到功率放大器的输入。
图16为可实现为嵌套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中的初级控制器12952和次级(内部)反馈环路12956中的次级控制器12955。初级控制器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。初级控制器12952控制初级过程12958,并且次级控制器12955控制次级过程12960。初级过程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产生施加到初级控制器12952的单个和输出信号。初级控制器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。初级控制器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)与测量的过程变量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根据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来监测和控制其它变量和设定点。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13206(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132020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132020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或本文所述的其它算法,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,并且可使用该反馈来调节并控制输出频率fo
温度推断
图19A-19B为根据本公开的至少一个方面的具有冷(室温)超声刀和热超声刀的相同超声装置的复阻抗光谱的图形表示133000、133010。如本文所用,冷超声刀是指室温下的超声刀,而热超声刀是指在使用中摩擦加热后的超声刀。图19A为作为具有冷超声刀和热超声刀的相同超声装置的谐振频率fo的函数的阻抗相位角
Figure BDA0002672386690000612
的图形表示133000,并且图19B为作为具有冷超声刀和热超声刀的相同超声装置的谐振频率fo的函数的阻抗量值|Z|的图形表示133010。阻抗相位角
Figure BDA0002672386690000613
和阻抗量值|Z|在谐振频率fo处处于最小值。
超声换能器阻抗Zg(t)可被测量为驱动信号发生器电压Vg(t)驱动信号和电流Ig(t)驱动信号的比率:
Figure BDA0002672386690000611
如图19A中所示,当超声刀为冷的(例如,在室温下)并且未摩擦加热时,超声装置的机电谐振频率fo为大约55,500Hz,并且超声换能器的激发频率被设定为55,500Hz。因此,当超声换能器在机电谐振频率fo下被激发并且超声刀为冷的时,相位角
Figure BDA0002672386690000614
处于最小值或大约0Rad,如由冷刀曲线图133002所指示的。如图19B中所示,当超声刀为冷的并且超声换能器在机电谐振频率fo下被激发时,阻抗量值|Z|为800Ω,例如阻抗量值|Z|处于最小阻抗处,并且驱动信号振幅由于超声机电系统的串联谐振等效电路而处于最大值处,如图6所描绘。
现在重新参考图19A和图19B,当超声换能器在55,500Hz的机电谐振频率fo下由发生器电压Vg(t)信号和发生器电流Ig(t)信号驱动时,发生器电压Vg(t)信号和发生器电流Ig(t)信号之间的相位角
Figure BDA0002672386690000615
为零,阻抗量值|Z|处于最小阻抗处(例如,800Ω),并且信号振幅由于超声机电系统的串联谐振等效电路而处于峰值或最大值。当超声刀的温度提高时,由于在使用中生成的摩擦热,超声装置的机电谐振频率fo'降低。因为超声换能器驱动发电机电压仍被55,500Hz的先前(冷刀)机电谐振频率fo下的发生器电压Vg(t)信号和发生器电流Ig(t)信号驱动,所以超声装置非谐振fo’操作,从而导致发生器电压Vg(t)信号和发生器电流Ig(t)信号之间的相位角
Figure BDA0002672386690000621
的偏移。相对于55,500Hz的先前的(冷刀)机电谐振频率,还存在阻抗量值|Z|的增大和驱动信号的峰值量值的下降。因此,可通过测量当机电谐振频率fo由于超声刀的温度变化而改变时发生器电压Vg(t)信号和发生器电流Ig(t)信号之间的相位角
Figure BDA0002672386690000622
来推断超声刀的温度。
如前所述,机电超声系统包括超声换能器、波导和超声刀。超声换能器可被建模成等效串联谐振电路(参见图6),该等效串联谐振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。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机电谐振频率。超声换能器由等于机电谐振频率(例如,机电超声系统的谐振频率)的频率下的交流电压Vg(t)信号和电流Ig(t)信号激发。当在谐振频率下激发机电超声系统时,电压Vg(t)信号和电流Ig(t)信号之间的相位角
Figure BDA0002672386690000623
为零。
换句话说,在谐振时,机电超声系统的模拟电感阻抗等于机电超声系统的模拟电容阻抗。当超声刀例如由于与组织的摩擦接合而加热时,超声刀(被建模为模拟电容)的顺应性导致机电超声系统的谐振频率偏移。在本示例中,当超声刀的温度提高时,机电超声系统的谐振频率降低。因此,机电超声系统的模拟电感阻抗不再等于机电超声系统的模拟电容阻抗,从而导致机电超声系统的驱动频率与新谐振频率之间失配。因此,利用热超声刀,机电超声系统“非谐振”操作。驱动频率与谐振频率之间的失配表现为施加到超声换能器的电压Vg(t)信号和电流Ig(t)信号之间的相位角
Figure BDA0002672386690000624
如此前所讨论,发生器电子器件可以很容易地监测施加到超声换能器的电压Vg(t)信号和电流Ig(t)信号之间的相位角
Figure BDA0002672386690000625
相位角
Figure BDA0002672386690000626
可通过傅立叶分析、加权最小二乘估计、卡尔曼滤波、基于空间矢量的技术、零点交叉方法、Lissajous图、三伏特计法、交叉线圈法、矢量伏特计和矢量阻抗法、相位标准器械、锁相环路等来确定。发生器可连续地监测相位角
Figure BDA0002672386690000627
并调节驱动频率,直到相位角
Figure BDA0002672386690000628
变为零。此时,新驱动频率等于机电超声系统的新谐振频率。相位角
Figure BDA0002672386690000629
和/或发生器驱动频率的变化可用作超声刀的温度的间接或推断的测量值。
多种技术可用于从这些光谱中的数据估计温度。最值得注意的是,可以采用时间变化的非线性状态空间公式组来对超声刀的温度和所测量的阻抗之间的动态关系进行建模
Figure BDA0002672386690000631
在发生器驱动频率范围内,其中发生器驱动频率的范围特定于装置模型。
温度估计方法
估计或推断超声刀的温度的一个方面可包括三个步骤。首先,限定取决于时间和能量的温度和频率的状态空间模型。为了将温度建模为频率内容的函数,使用一组非线性状态空间公式来对机电谐振频率与超声刀的温度之间的关系进行建模。其次,应用卡尔曼滤波器来提高温度估计器和状态空间模型随时间变化的准确性。再次,在卡尔曼滤波器的反馈环路中提供状态估计器以控制施加到超声换能器以及因此超声刀的功率,从而调整超声刀的温度。下文描述了这三个步骤。
步骤1
第一步是限定取决于时间和能量的温度和频率的状态空间模型。为了将温度建模为频率内容的函数,使用一组非线性状态空间公式来对机电谐振频率与超声刀的温度之间的关系进行建模。在一个方面,状态空间模型由以下限定:
Figure BDA0002672386690000632
Figure BDA0002672386690000633
状态空间模型表示相对于固有频率Fn(t)、温度T(t)、能量E(t)和时间t的机电超声系统的固有频率
Figure BDA0002672386690000634
的变化率和超声刀的温度
Figure BDA0002672386690000635
的变化率。
Figure BDA0002672386690000636
表示可测量且可观察的变量诸如机电超声系统的固有频率Fn(t)、超声刀的温度T(t)、施加到超声刀的能量E(t)和时间t的可观察性。超声刀的温度T(t)可观察为估计。
步骤2
第二步是应用卡尔曼滤波器来改善温度估计器和状态空间模型。图20为根据以下公式基于阻抗来改善温度估计器和状态空间模型的卡尔曼滤波器133020的图示:
Figure BDA0002672386690000641
其表示根据本公开的至少一个方面的在多种频率下测量的跨超声换能器的阻抗。
可采用卡尔曼滤波器133020来改善温度估计的性能,并且允许增加外部传感器、模型或先前的信息以改善噪声数据中的温度预测。卡尔曼滤波器133020包括调整器133022和设备(plant)133024。在对照理论中,设备133024是过程和致动器的组合。设备133024被称为具有转换函数,该转换函数指示系统的输入信号和输出信号之间的关系。调整器133022包括状态估计器133026和控制器K 133028。状态调整器133026包括反馈环路133030。状态调整器133026接收y、设备133024的输出作为输入和反馈变量u。状态估计器133026是与系统状态的真值会聚的内部反馈系统。状态估计器133026的输出为全反馈控制变量
Figure BDA0002672386690000642
包括机电超声系统的Fn(t)、超声刀的温度T(t)的估计、施加到超声刀的能量E(t)、相位角
Figure BDA0002672386690000643
和时间t。到控制器K 133028的输入为
Figure BDA0002672386690000644
并且控制器K 133028的输出u被馈送回到状态估计器133026和设备133024的t。
卡尔曼滤波(也称为线性二次估计(LQE))是一种算法,该算法使用随时间推移观察到的一系列测量值(包含统计噪声和其它不准确性),并通过估计每个时帧的变量的联合概率分布并因此计算实际测量的最大似然估计来产生未知变量的估计。该算法以两步过程中工作。在预测步骤中,卡尔曼滤波器133020产生当前状态变量的估计以及它们的不确定性。一旦观察到下一次测量的结果(必然因一定数量的误差(包括随机噪声)而损坏),则使用加权平均值来更新这些估计,给出的权重越高,就以越高的确定性进行估计。该算法是递归的并且可实时运行,仅使用当前输入测量值和先前计算的状态及其不确定性矩阵;不需要附加的过去的信息。
卡尔曼滤波器133020使用机电超声系统的动力学模型、该系统已知的对照输入、以及向超声换能器施加的信号的固有频率和相位角的多个时序测量值(观测值)(例如,超声换能器的电阻抗的量值和相位)来形成机电超声系统的变化量的(其状态)的估计,以优于仅使用一个单独测量获得的估计地预测机电超声系统的超声刀部分的温度。因此,卡尔曼滤波器133020是包括传感器和数据融合以提供超声刀的温度的最大似然估计的算法。
卡尔曼滤波器133020有效地处理由于向超声换能器施加的信号的噪声测量而导致的不确定性,以测量固有频率和相移数据,并且还有效地处理由于随机外部因素造成的不确定性。卡尔曼滤波器133020以系统的预测状态和使用加权平均值的新测量的平均值产生机电超声系统的状态的估计。加权值提供更好的(即,较小的)估计的不确定性,并且比未加权的值更“可信任”。权重可由协方差、对系统状态预测的估计不确定性的测量来计算。加权平均值的结果是位于预测状态和测量状态之间的新状态估计,并且具有比单独一个更好的估计不确定性。此过程在每一步重复,其中新的估计及其协方差告知在以下迭代中使用的预测。卡尔曼滤波器133020的该递归性质仅需要机电超声系统的状态的上一个“最佳猜测”而不是整个历史来计算新状态。
测量和电流状态估计的相对确定性是重要的考虑因素,并且常见的是讨论滤波器在卡尔曼滤波器133020的增益K方面的响应。卡尔曼增益K是赋予测量值和电流状态估计的相对权重,并且可被“调谐”以实现特定性能。利用高增益K,卡尔曼滤波器133020对最近的测量值施加更多的权重,并因此更响应地遵循它们。使用低增益K,卡尔曼滤波器133020更密切地遵循模型预测。在极端情况下,接近一的高增益将导致估计轨迹较具跳跃性,而接近零的低增益将使噪声平滑但降低响应能力。
当执行卡尔曼滤波器133020的实际计算时(如下所述),状态估计和协方差被编码为矩阵以处理单组计算中涉及的多个维度。这允许表示在转变模型或协方差中的任一者中的不同状态变量(诸如位置、速度和加速度)之间的线性关系。使用卡尔曼滤波器133020并不假定误差是高斯。但是,在所有误差都是高斯分布的特殊情况下,卡尔曼滤波器133020产生精确的条件概率估计。
步骤3
第三步使用卡尔曼滤波器133020的反馈环路133032中的状态估计器133026来控制施加到超声换能器并且因此施加到超声刀的功率,以调整超声刀的温度。
图21为根据本公开的至少一个方面的图20中所示的卡尔曼滤波器133020的状态估计器133026用来最大化估计值的三个概率分布的图形表示133040。概率分布包括先前的概率分布133042、预测(状态)概率分布133044和观察概率分布133046。根据本公开的至少一个方面,三个概率分布133042、133044、1330467用于对施加到超声换能器的功率的反馈控制,以基于在多种频率下测量的跨超声换能器的阻抗来调整温度。在用于基于阻抗调整温度的施加到超声换能器的功率的反馈控制中使用的估计器由以下表达式限定:
Figure BDA0002672386690000661
其为根据本公开的至少一个方面的在多种频率下测量的跨超声换能器的阻抗。
先前的概率分布133042包括由以下表达式限定的状态方差:
Figure BDA0002672386690000662
状态方差
Figure BDA0002672386690000663
用于预测系统的下一个状态,该状态表示为预测(状态)概率分布133044。观察概率分布133046是观测方差σm用于限定增益的系统的状态的实际观察的概率分布,该增益由以下表达式限定:
Figure BDA0002672386690000664
反馈控制
降低功率输入以确保温度(如由状态估计器和卡尔曼滤波器所估计的)被控制。
在一个方面,初始概念证明假设机电超声系统的固有频率与超声刀的温度之间存在静态线性关系。通过降低作为机电超声系统的固有频率的函数的功率(即,用反馈控制调整温度),可直接控制超声刀尖端的温度。在该示例中,超声刀的远侧尖端的温度可被控制为不超过Teflon垫的熔点。
图22A为不具有温度反馈控制的超声装置的温度与时间关系的图形表示133050。超声刀的温度(℃)沿竖直轴线显示,并且时间(秒)沿水平轴线显示。用位于超声装置的钳口中的羚羊皮进行测试。一个钳口为超声刀,而另一个钳口为具有TEFLON垫的夹持臂。超声刀在谐振频率下被激发,同时与夹持在超声刀和夹持臂之间的羚羊皮摩擦接合。随着时间的推移,超声刀的温度(℃)由于与羚羊皮的摩擦接合而增大。随着时间的推移,超声刀的温度分布133052增大,直到在220℃的温度下约19.5秒后切割羚羊皮样本为止,如在点133054处所指示。在没有温度反馈控制的情况下,在切割羚羊皮样本之后,超声刀的温度提高到远高于TEFLON熔点的温度~380℃至~490℃。在点133056处,超声刀的温度达到490℃的最高温度,直到TEFLON垫完全熔融。在垫完全消失之后,超声刀的温度从点133056处的峰值温度略微下降。
图22B为根据本发明的至少一个方面的具有温度反馈控制的超声装置的温度与时间关系的曲线图。超声刀的温度(℃)沿竖直轴线显示,并且时间(秒)沿水平轴线显示。用位于超声装置的钳口中的羚羊皮样本进行测试。一个钳口为超声刀,而另一个钳口为具有TEFLON垫的夹持臂。超声刀在谐振频率下被激发,同时与夹持在超声刀和夹持臂垫之间的羚羊皮摩擦接合。随着时间的推移,超声刀的温度分布133062增大,直到在220℃的温度下约23秒后切割羚羊皮样本为止,如在点133064处所指示。在温度反馈控制的情况下,如在点133066处所指示,超声刀的温度升高到约380℃的最高温度,刚好低于TEFLON的熔点,然后如一般在区域133068处所指示降低到约330℃的平均值,从而防止TEFLON垫熔融。
用于垫保护的受控热管理(CTM)
在一个方面,本公开提供一种受控热管理(CTM)算法以利用反馈控制调整温度。反馈控制的输出可用于防止超声端部执行器夹持臂垫烧穿,这对于超声外科器械而言不是所期望的效果。如前所述,一般来讲,垫烧穿是由于超声能量在被抓握在在端部执行器中的组织已被横切之后继续施加到与垫接触的超声刀上引起的。
CTM算法利用如下事实:通常由钛制成的超声刀的谐振频率随温度而变化。随着温度升高,超声刀的弹性模量降低,超声刀的固有频率也降低。要考虑的因素是,当超声刀的远侧端部是热的但波导是冷的时,与超声刀的远侧端部和波导均为热的时相比,实现预定温度的频率差值(δ)不同。
在一个方面,CTM算法计算超声换能器驱动信号的频率变化,该频率变化是在激活开始时(锁定时)达到作为超声机电系统谐振频率的函数的某一预定温度所需的。包括通过超声波导联接到超声刀的超声换能器的超声机电系统具有预定义的谐振频率,该谐振频率随温度变化而变化。锁定时超声机电系统的谐振频率可用于估计超声换能器驱动频率的变化,该变化是实现温度端点以考虑超声刀的初始热状态所需的。超声机电系统的谐振频率可作为超声换能器或超声波导或超声刀的温度或这些部件的组合的函数而变化。
图23为根据本公开的至少一个方面的初始谐振频率(锁定频率)与实现大约340℃的温度所需的频率变化(δ频率)之间的关系的图示133300。达到大约340℃的超声刀温度所需的频率的变化沿垂直轴示出,并且机电超声系统在锁定时的谐振频率沿水平轴示出。基于被示出为散射曲线图的测量数据点133302,在达到大约340℃的超声刀温度所需的频率变化与锁定时的谐振频率之间存在线性关系133304。
在谐振频率锁定时,CTM算法采用在锁定频率和达到刚好低于TEFLON垫的熔点(大约340℃)的温度所需的δ频率之间的线性关系133304。根据本公开的至少一个方面,一旦频率在距离频率下限一定的缓冲距离内,如图24中所示,包括超声发生器133312的反馈控制系统133310调整施加到超声机电系统133314的超声换能器的电流(i)设定点,以防止超声换能器的频率(f)降低到低于预定阈值。降低电流设定点可降低超声刀的位移,这继而降低超声刀的温度并提高超声刀的固有频率。该关系允许改变施加到超声换能器的电流,以调整超声刀的固有频率并间接控制超声刀或超声机电系统133314的温度。在一个方面,发生器133312可被实现为参考图2、图7、图8A-8C和图9A-9B所述的超声发生器。反馈控制系统133310可被实现为参考图16-17所述的PID控制器,例如。
图25为根据本公开的至少一个方面的用于保护超声端部执行器中的夹持臂垫的受控热管理(CTM)算法的方法或逻辑配置的流程图133320。通过流程图133320示出的方法或逻辑配置可由如本文所述的超声发生器133312或位于超声器械中的控制电路或它们的组合来执行。如前所述,发生器133312可被实现为参考图2、图7、图8A-8C和图9A-9B所述的发生器。
在一个方面,发生器133312中的控制电路最初通过将电流施加到超声换能器来激活超声器械。超声机电系统的谐振频率最初在超声刀温度为冷的或接近室温的初始条件下被锁定。当超声刀的温度由于与组织的摩擦接触而增大时,例如,控制电路监测超声机电系统的谐振频率的变化或δ,并且确定133324是否已达到预定刀温度的δ频率阈值。如果δ频率低于阈值,则方法沿“否”分支继续,并且控制电路继续寻找133324新谐振频率并监测δ频率。当δ频率满足或超过δ频率阈值时,该方法沿“是”分支继续,并且计算133326新的频率下限(阈值),该频率下限对应于夹持臂垫的熔点。在一个非限制性示例中,夹持臂垫由TEFLON制成,并且熔点为大约340℃。
一旦计算出133326的新频率下限,控制电路确定133328谐振频率是否接近新计算的频率下限。例如,在TEFLON夹持臂垫的情况下,控制电路例如基于当前谐振频率确定133328超声刀温度是否接近350℃。如果当前谐振频率高于频率下限,则该方法沿“否”分支继续,并且将正常水平的电流施加133330到适于组织横切的超声换能器。另选地,如果当前谐振频率处于或低于频率下限,则方法沿“是”分支继续,并且通过修改施加到超声换能器的电流来调整133332谐振频率。例如,在一个方面,控制电路采用如参考图16-17所述的PID控制器。控制电路调节133332环路中的频率,以确定133328频率何时接近下限,直到“密封和切割”外科规程终止并且超声换能器停用为止。由于逻辑流程图133320所示的CTM算法仅在或接近夹持臂垫的熔点处有效,因此在横切组织之后激活CTM算法。
对样本进行的爆裂压力测试表明,当采用逻辑流程图133320所描绘的CTM方法或逻辑配置来密封和切割血管或其它组织时,对密封件的破裂压力没有影响。此外,基于测试样本,横切次数受到影响。此外,温度测量证实,与没有CTM反馈算法控制的装置相比,超声刀温度受CTM算法的限制,并且在最大功率下在最大功率下进行10次击发(在击发之间休息5秒)的装置显示显著减少的垫磨损,而没有CTM算法反馈控制的装置在该滥用测试中没有持续超过2次击发。
图26为根据本公开的至少一个方面的温度对时间的图示133340,其比较了超声刀与智能超声刀和常规超声刀的期望温度。温度(摄氏度)沿竖直轴线显示,并且时间(秒)沿水平轴线显示。在曲线图中,点划线是表示超声刀的期望温度的温度阈值133342。实线是在参考图24和图25所述的CTM算法的控制下的智能超声刀的温度对时间曲线133344。点划线为常规超声刀的温度对时间曲线133346,该常规超声刀不在参考图24和图25所述的CTM算法的控制下。如图所示。一旦在CTM算法控制下的智能超声刀的温度超过期望的温度阈值(~340℃),CTM算法就进行控制并调整智能超声刀的温度以尽可能接近地匹配该阈值,直到横切规程完成并且超声换能器的功率被停用或切断。
在另一方面,本公开提供了一种用于超声装置(诸如,超声剪刀)的“仅密封”组织效应的CTM算法。一般来讲,超声外科器械通常同时密封并切割组织。由于在开始切割之前不确定密封何时完成,因此仅使用超声技术来制造配置为能够仅密封而不切割的超声装置并不难实现。在一个方面,CTM算法可以被配置为通过允许超声刀的温度超过切割(横切)组织所需的温度,但不超过夹持臂垫的熔点,来保护端部执行器夹持臂垫。在另一方面,仅CTM密封算法可以被调谐为超过组织的密封温度(基于实验大约115℃到大约180℃),但是不超过组织的切割(横切)温度(大约180℃到大约350℃)。在后一种配置中,仅CTM密封算法提供已成功展示的“仅密封”组织效应。例如,在计算相对于初始锁定频率的频率变化的线性拟合中,如图25中所示,改变拟合的截距调整超声刀的最终稳态温度。通过调节截距参数,超声刀可被设定至从不超过大约180℃,从而导致组织密封但不切割。在一个方面,提高夹持力可改善密封方法而不影响夹持臂垫烧穿,因为刀的温度由仅CTM密封算法控制。如前所述,例如,仅CTM密封算法可通过参考图2、图7、图8A-8C、图9A-9B、图16和图17所述的发生器和PID控制器来实现。因此,可以修改图25中所示的流程图133320,使得控制电路计算133326新的频率下限(阈值t与“仅密封”温度对应,诸如大约180℃,确定133328频率何时接近下限,并且调整133332温度,直到“仅密封”外科规程终止并且超声换能器被停用为止。
在另一方面,本发明提供了一种冷却热监测(CTMo)算法,其被配置为检测无创伤抓握何时是可行的。声学超声能量导致超声刀温度为大约230℃至大约300℃,以实现切割或横切组织的期望效果。因为热在超声换能器停用后保留在超声刀的金属主体内一段时间,所以如果在超声刀有机会冷却之前使用超声端部执行器抓握组织,则存储在超声刀中的残余热可导致组织损伤。
在一个方面,CTMo算法计算超声机电系统的固有频率从热状态下的固有频率到无损伤抓握而不损坏端部执行器抓握的组织的温度下的固有频率的变化。在激活超声换能器之后的直接或预定时间段内,将非治疗信号(大约5mA)施加到超声换能器,该非治疗信号包含例如大约48,000Hz到52,000Hz的频率带宽,在该带宽下期望找到固有频率。在用非治疗性信号刺激超声换能器期间测量的超声换能器阻抗的FFT算法或检测超声机电系统的固有频率的其它数学上有效的算法将指示超声刀的固有频率是阻抗量值最小的频率。以这种方式连续激励超声换能器提供了在FFT或用于估计或测量固有频率的其它算法的频率分辨率内的超声刀固有频率的连续反馈。当检测到对应于对无创抓握可行的温度的固有频率变化时,提供音调、或LED、或屏幕显示或其它形式的通知、或它们的组合来指示该装置能够无创抓取。
在另一方面,本公开提供了一种CTM算法,该CTM算法被配置为针对密封和切割或横切的结束进行色调化。提供“组织密封”和“切割结束”通知对于常规超声装置是一种挑战,因为温度测量不能容易地直接安装到超声刀并且刀使用传感器未明确地检测到夹持臂垫。CTM算法可指示超声刀的温度状态,并且可用于指示“切割结束”或“组织密封”、,或两者,因为这些均为基于温度的事件。
在一个方面,根据本公开的CTM算法检测到“切割结束”状态并激活通知。组织通常以高概率在大约210℃至大约320℃下切割。CTM算法可以在320℃(或类似温度)激活音调,以指示在组织上的进一步激活是无效的,因为组织可能被切割,并且超声刀现在抵靠夹持臂垫行进,这在CTM算法激活时是可接受的,因为它控制超声刀的温度。在一个方面,CTM算法被编程为当超声刀的温度估计已经达到320℃时,控制或调整超声换能器的功率,以将超声刀的温度保持在大约320℃。此时开始音调提供了组织已被切割的指示。CTM算法基于频率随温度的变化。在确定初始状态温度(基于初始频率)之后,CTM算法可计算对应于表示组织何时被切割的温度的频率变化。例如,如果起始频率为51,000Hz,则CTM算法将计算实现320℃所需的频率变化,该频率变化可能为-112Hz。然后它将开始控制以保持该频率设定点(例如,50,888Hz),从而调整超声刀的温度。类似地,可基于指示超声刀何时处于指示组织可能被切割的温度的初始频率来计算频率变化。此时,CTM算法不必控制功率,而只是启动音调以指示组织的状态,或者CTM算法可在此时控制频率以维持该温度(如果需要)。无论哪种方式,均指示“切割结束”。
具有温度控制的超声密封算法
超声刀温度控制的超声密封算法可用于利用本文所述的频率温度反馈控制算法来改善止血,以利用超声刀的频率/温度关系。
在一个方面,可采用频率温度反馈控制算法来基于测量的与温度相关的谐振频率(使用光谱学)来改变施加到超声换能器的功率水平,如本公开的各个方面所描述。在一个方面,频率温度反馈控制算法可通过超声器械上的能量按钮来激活。
已知的是最佳的组织效应可通过在密封循环中尽早增加驱动超声换能器的功率水平(例如,通过增加施加到超声换能器的驱动电压Vg(t)或电流Ig(t)或两者)以快速加热组织并使组织脱水,然后降低驱动超声换能器的功率水平(例如,通过降低施加到超声换能器的驱动电压Vg(t)或电流Ig(t)或两者)以慢慢允许形成最终密封来获得。在一个方面,根据本公开的频率温度反馈控制算法设定当组织在更高功率水平级期间加热时可达到的温度阈值的限制,并且然后基于夹持钳口垫(例如,TEFLON)的熔点温度降低功率水平以控制超声刀的温度从而完成密封。控制算法可通过激活器械上的能量按钮以进行更响应性/自适应密封来实现,以进一步降低止血算法的复杂性。
图27为根据本公开的至少一个方面的描绘提供具有温度控制的超声密封的控制程序或逻辑配置的过程的逻辑流程图133180。根据控制算法,发生器或器械或两者的处理器或控制电路使用光谱学(例如,智能刀)激活133182超声刀感测,并且测量133184超声刀的谐振频率(例如,超声机电系统的谐振频率),以使用如本文所述的频率温度反馈控制算法(光谱学)来确定超声刀的温度。如前所述,超声机电系统的谐振频率被标测以获得作为机电超声系统的谐振频率的函数的超声刀的温度。
超声机电系统的第一期望谐振频率fx对应于超声刀的第一期望温度Z°。在一个方面,第一期望超声刀温度Z°为组织凝结的最佳温度(例如,450℃)。超声机电系统的第二期望频率fY对应于超声刀的第二期望温度ZZ°。在一个方面,第二期望超声刀温度ZZ°为330℃的温度,其低于夹持臂垫的熔点温度,对于TEFLON,该熔点温度为大约380℃。
发生器或器械或两者的处理器或控制电路将超声机电系统的测量的谐振频率与第一期望频率fx进行比较133186。换句话讲,该方法确定超声刀的温度是否大于最佳组织凝结的温度。如果超声机电系统的所测量的谐振频率小于第一期望频率fx,则该沿NO分支继续,并且发生器或器械或两者的处理器或控制电路增加133188施加到超声换能器的功率水平以增加超声刀的温度,直到超声机电系统的测量的谐振频率超过第一期望频率fx为止。在这种情况下,组织凝结过程完成,并且该方法将超声刀的温度控制为对应于第二期望频率fy的第二期望温度。
该方法沿YES分支继续,并且发生器或器械或两者的处理器或控制电路降低133190施加到超声换能器的功率水平以降低超声刀的温度。发生器或器械或两者的处理器或控制电路测量133192超声机电系统的谐振频率,并且将所测量的谐振频率与第二期望频率fY进行比较。如果所测量的谐振频率不小于第二期望频率fY,则发生器或器械或两者的处理器或控制电路降低133190超声功率水平,直到测量的谐振频率小于第二期望频率fY为止。频率温度反馈控制算法将超声机电系统的测量的谐振频率保持低于第二期望频率fy,例如,超声刀的温度小于夹持臂垫的熔点的温度,然后,发生器执行增加施加到超声换能器的功率水平以增加超声刀的温度,直到组织横切过程完成133196为止。
图28为根据本公开的至少一个方面的作为时间的函数的超声换能器电流和超声刀温度的图形表示133200。图28示出了应用图27中所述的频率温度反馈控制算法的结果。图示133200示出相对于作为时间的函数的超声换能器电流Ig(t)的第二曲线图133204的作为时间的函数的超声刀温度的第一曲线图133202。如图所示,换能器Ig(t)保持恒定,直到超声刀温度达到450°为止,该温度是最佳凝结温度。一旦超声刀温度达到450°,频率温度反馈控制算法就会降低换能器电流Ig(t),直到超声刀的温度降低到330°以下,该温度低于例如TEFLON垫的熔点温度。
在一个方面,根据本公开的CTM算法检测“组织密封”状态并激活通知。与切割结束检测类似,组织在大约105℃和约200℃之间密封。从指示超声刀的温度已达到200℃所需的初始频率(其指示仅密封状态)开始的频率变化可在超声换能器开始激活时计算。CTM算法可以在这一点激活音调,并且如果外科医生希望获得仅密封状态,外科医生可以停止激活或者获得仅密封状态。外科医生可以停止激活超声换能器,并且从这一点开始自动启动特定的仅密封算法,或者外科医生可以继续激活超声换能器以获得组织切割状态。
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,也可使用其它材料。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通过使用框图、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意组合来实现。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意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/或固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、闪存存储器或其它存储器。此外,指令可经由网络或通过其它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发射以机器(例如,计算机)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、声学信号或其它形式的传播信号(例如,载波、红外信号、数字信号等)在因特网上发射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)可读的形式存储或发射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)、现场可编程门阵列(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、以及它们的任意组合。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装置的电子电路(如,至少部分地实施本文所述的方法和/或装置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/或装置的由计算机程序配置的微处理器)、形成存储设备(如,随机存取存储器的形式)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现本文所述的主题。
如本文的任何方面所用,术语“逻辑”可指被配置为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。固件可以体现为在存储设备中硬编码(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”是指导致所需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/或逻辑状态可以(但不一定)采用能被存储、转换、组合、比较和以其它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月发布的名为“IEEE 802.3标准”的以太网标准和/或本标准的更高版本。另选地或附加地,通信装置可以能够使用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网络互通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它此类信息存储、传输或显示设备内的物理量的其它数据。
一个或多个部件在本文中可被称为“被配置为”、“可被配置为”、“可操作/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“被配置为”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,在没有其它修饰语的情况下,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,这种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,这种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,尽管以序列出了多个操作流程图,但应当理解,可以不同于所示顺序的其它顺序进行所述多个操作,或者可以同时进行所述多个操作。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、或其它改变的排序。此外,除非上下文另有规定,否则像“响应于”、“相关”这样的术语或其它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、结构或特性包括在至少一个方面中。因此,在整个说明书的不同位置出现的短语“在一个方面”、“在一方面”、“在一范例”、“在一个范例”不一定都指同一方面。此外,具体特征、结构或特性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,非专利公布或其它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、陈述或其它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与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所述多个形式和多种修改形式。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1:一种利用温度控制进行超声密封的方法,所述方法包括:
激活超声刀温度感测;
测量超声机电系统的第一谐振频率,其中所述超声机电系统包括经由超声波导联接到超声刀的超声换能器;
在所述第一预定谐振频率对应于所述超声刀的第一预定温度的条件下在所测量的第一谐振频率和第一预定谐振频率之间进行第一比较;以及
基于所述第一比较来调节施加到所述超声换能器的功率水平。
实施例2:根据实施例1所述的方法,其中,在所述第一预定谐振频率对应于第一预定温度的条件下在所测量的第一谐振频率和第一预定谐振频率之间进行第一比较,包括:在所述第一预定谐振频率对应于最佳组织凝结温度的条件下在所测量的第一谐振频率和第一预定谐振频率之间进行第一比较。
实施例3:根据实施例1至2中任一个或多个所述的方法,还包括确定组织密封过程的完成。
实施例4:根据实施例1至3中任一个或多个所述的方法,还包括:
测量所述超声机电系统的第二谐振频率;
在所述第二预定谐振频率对应于所述超声刀的第二预定温度的条件下在所测量的第二谐振频率和第二预定谐振频率之间进行第二比较;以及
基于所述第二比较来调节施加到所述超声换能器的所述功率水平。
实施例5:根据实施例4所述的方法,其中,在所述第二预定谐振频率对应于第二预定温度的条件下在所测量的第二谐振频率和第二预定谐振频率之间进行第二比较,包括:在所述第二预定谐振频率对应于夹持臂垫的熔点温度的条件下在所测量的第二谐振频率和第二预定谐振频率之间进行第二比较。
实施例6:根据实施例4至5中任一个或多个所述的方法,还包括提高施加到所述超声换能器的所述功率水平,直到所述超声密封完成。
实施例7:一种超声外科器械,包括:
超声机电系统,所述超声机电系统包括经由超声波导联接到超声
刀的超声换能器;
夹持臂垫;以及
发生器,所述发生器被配置为向所述超声换能器供应功率,其中所述发生器包括控制电路,所述控制电路被配置为:
激活超声刀温度感测;
测量所述超声机电系统的第一谐振频率;
在所述第一预定谐振频率对应于所述超声刀的第一预定温度的条件下在所测量的第一谐振频率和第一预定谐振频率之间进行第一比较;以及
基于所述比较来调节施加到所述超声换能器的功率水平。
实施例8:根据实施例7所述的超声外科器械,其中,所述超声刀的所述第一预定温度对应于最佳组织凝结温度。
实施例9:根据实施例7至8中任一个或多个所述的超声外科器械,其中,所述控制电路还被配置为确定组织密封过程的完成。
实施例10:根据实施例7至9中任一个或多个所述的超声外科器械,其中,所述控制电路还被配置为:
测量所述超声机电系统的第二谐振频率;
在所述第二预定谐振频率对应于所述超声刀的第二预定温度的条件下在所测量的谐振频率和第二预定谐振频率之间进行第二比较;以及
基于所述第二比较来调节施加到所述超声换能器的所述功率水平。
实施例11:根据实施例10所述的超声外科器械,其中,所述超声刀的所述第二预定温度对应于所述夹持臂垫的熔点。
实施例12:根据实施例10至11中任一个或多个所述的超声外科器械,其中,所述控制电路还被配置为提高施加到所述超声换能器的所述功率水平,直到所述超声密封完成。
实施例13:一种用于超声外科器械的发生器,所述发生器包括:
控制电路,所述控制电路被配置为:
激活超声刀温度感测;
测量所述超声机电系统的第一谐振频率;
在所述第一预定谐振频率对应于所述超声刀的第一预定温度的条件下在所测量的第一谐振频率和第一预定谐振频率之间进行第一比较;以及
基于所述第一比较来调节施加到所述超声换能器的功率水平。
实施例14:根据实施例13所述的发生器,其中,所述超声刀的所述第一预定温度对应于最佳组织凝结温度。
实施例15:根据实施例13至14中任一个或多个所述的发生器,其中,所述控制电路还被配置为确定组织密封过程的完成。
实施例16:根据实施例13至15中任一个或多个所述的发生器,其中,所述控制电路还被配置为:
测量所述超声机电系统的第二谐振频率;
在所述第二预定谐振频率对应于所述超声刀的第二预定温度的条件下在所测量的第二谐振频率和第二预定谐振频率之间进行第二比较;以及
基于所述第二比较来调节施加到所述超声换能器的所述功率水平。
实施例17:根据实施例16所述的发生器,其中,所述超声刀的所述第二预定温度对应于夹持臂垫的熔点。
实施例18:根据实施例16至17中任一个或多个所述的发生器,其中,所述控制电路还被配置为提高施加到所述超声换能器的所述功率水平,直到所述超声密封完成。
实施例19:一种超声外科系统,包括:
处理器和非暂态存储器,其中所述非暂态存储器包含指令,所述指令在由所述处理器执行时致使所述处理器:
激活超声刀温度感测;
测量所述超声机电系统的第一谐振频率;
在所述第一预定谐振频率对应于所述超声刀的第一预定温度的条件下在所测量的第一谐振频率和第一预定谐振频率之间进行第一比较;
基于所述第一比较来调节施加到所述超声换能器的功率水平;
测量所述超声机电系统的第二谐振频率;
在所述第二预定谐振频率对应于所述超声刀的第二预定温度的条件下在所测量的第二谐振频率和第二预定谐振频率之间进行比较;以及
基于所述第二比较来调节施加到所述超声换能器的所述功率水平。

Claims (19)

1.一种利用温度控制进行超声密封的方法,所述方法包括:
激活超声刀温度感测;
测量超声机电系统的第一谐振频率,其中所述超声机电系统包括经由超声波导联接到超声刀的超声换能器;
在所述第一预定谐振频率对应于所述超声刀的第一预定温度的条件下在所测量的第一谐振频率和第一预定谐振频率之间进行第一比较;以及
基于所述第一比较来调节施加到所述超声换能器的功率水平。
2.根据权利要求1所述的方法,其中,在所述第一预定谐振频率对应于第一预定温度的条件下在所测量的第一谐振频率和第一预定谐振频率之间进行第一比较,包括:在所述第一预定谐振频率对应于最佳组织凝结温度的条件下在所测量的第一谐振频率和第一预定谐振频率之间进行第一比较。
3.根据权利要求1所述的方法,还包括确定组织密封过程的完成。
4.根据权利要求1所述的方法,还包括:
测量所述超声机电系统的第二谐振频率;
在所述第二预定谐振频率对应于所述超声刀的第二预定温度的条件下在所测量的第二谐振频率和第二预定谐振频率之间进行第二比较;以及
基于所述第二比较来调节施加到所述超声换能器的所述功率水平。
5.根据权利要求4所述的方法,其中,在所述第二预定谐振频率对应于第二预定温度的条件下在所测量的第二谐振频率和第二预定谐振频率之间进行第二比较,包括:在所述第二预定谐振频率对应于夹持臂垫的熔点温度的条件下在所测量的第二谐振频率和第二预定谐振频率之间进行第二比较。
6.根据权利要求4所述的方法,还包括提高施加到所述超声换能器的所述功率水平,直到所述超声密封完成。
7.一种超声外科器械,包括:
超声机电系统,所述超声机电系统包括经由超声波导联接到超声刀的超声换能器;
夹持臂垫;以及
发生器,所述发生器被配置为向所述超声换能器供应功率,其中所述发生器包括控制电路,所述控制电路被配置为:
激活超声刀温度感测;
测量所述超声机电系统的第一谐振频率;
在所述第一预定谐振频率对应于所述超声刀的第一预定温度的条件下在所测量的第一谐振频率和第一预定谐振频率之间进行第一比较;以及
基于所述比较来调节施加到所述超声换能器的功率水平。
8.根据权利要求7所述的超声外科器械,其中,所述超声刀的所述第一预定温度对应于最佳组织凝结温度。
9.根据权利要求7所述的超声外科器械,其中,所述控制电路还被配置为确定组织密封过程的完成。
10.根据权利要求7所述的超声外科器械,其中,所述控制电路还被配置为:
测量所述超声机电系统的第二谐振频率;
在所述第二预定谐振频率对应于所述超声刀的第二预定温度的条件下在所测量的谐振频率和第二预定谐振频率之间进行第二比较;以及
基于所述第二比较来调节施加到所述超声换能器的所述功率水平。
11.根据权利要求10所述的超声外科器械,其中,所述超声刀的所述第二预定温度对应于所述夹持臂垫的熔点。
12.根据权利要求10所述的超声外科器械,其中,所述控制电路还被配置为提高施加到所述超声换能器的所述功率水平,直到所述超声密封完成。
13.一种用于超声外科器械的发生器,所述发生器包括:
控制电路,所述控制电路被配置为:
激活超声刀温度感测;
测量所述超声机电系统的第一谐振频率;
在所述第一预定谐振频率对应于所述超声刀的第一预定温度的条件下在所测量的第一谐振频率和第一预定谐振频率之间进行第一比较;以及
基于所述第一比较来调节施加到所述超声换能器的功率水平。
14.根据权利要求13所述的发生器,其中,所述超声刀的所述第一预定温度对应于最佳组织凝结温度。
15.根据权利要求13所述的发生器,其中,所述控制电路还被配置为确定组织密封过程的完成。
16.根据权利要求13所述的发生器,其中,所述控制电路还被配置为:
测量所述超声机电系统的第二谐振频率;
在所述第二预定谐振频率对应于所述超声刀的第二预定温度的条件下在所测量的第二谐振频率和第二预定谐振频率之间进行第二比较;以及
基于所述第二比较来调节施加到所述超声换能器的所述功率水平。
17.根据权利要求16所述的发生器,其中,所述超声刀的所述第二预定温度对应于夹持臂垫的熔点。
18.根据权利要求16所述的发生器,其中,所述控制电路还被配置为提高施加到所述超声换能器的所述功率水平,直到所述超声密封完成。
19.一种超声外科系统,包括:
处理器和非暂态存储器,其中所述非暂态存储器包含指令,所述指令在由所述处理器执行时致使所述处理器:
激活超声刀温度感测;
测量所述超声机电系统的第一谐振频率;
在所述第一预定谐振频率对应于所述超声刀的第一预定温度的条件下在所测量的第一谐振频率和第一预定谐振频率之间进行第一比较;
基于所述第一比较来调节施加到所述超声换能器的功率水平;
测量所述超声机电系统的第二谐振频率;
在所述第二预定谐振频率对应于所述超声刀的第二预定温度的条件下在所测量的第二谐振频率和第二预定谐振频率之间进行比较;以及
基于所述第二比较来调节施加到所述超声换能器的所述功率水平。
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