CN107847263A - 具有基于组织阻抗的用户自适应技术的外科系统 - Google Patents
具有基于组织阻抗的用户自适应技术的外科系统 Download PDFInfo
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Abstract
一种治疗组织的方法,所述方法包括以一幅度向组织施加能量模态,测量所述组织的组织阻抗,基于所测得的组织阻抗调制所述能量模态的应用,以及当满足终止参数时停止应用所述能量模态。
Description
优先权
本申请要求2015年6月30日提交的美国临时申请序列号62/186,984、2015年9月30日提交的美国临时申请序列号62/235,260、2015年9月30日提交的美国临时申请序列号62/235,368、2015年9月30日提交的美国临时申请序列号62/235,466、2016年1月15日提交的美国临时申请序列号62/279,635、和2016年5月2日提交的美国临时申请序列号62/330,669的权益,这些申请全文以引用方式并入本文中。
技术领域
本公开整体涉及超声外科系统,且更具体而言,涉及允许外科医生执行切割和凝固并根据组织阻抗来调整和定制用于执行此类规程的技术的超声外科系统和电外科系统。
背景技术
超声外科器械凭这种器械的独特的性能特性而在外科规程中日益得到广泛的应用。依据特定器械构型和操作参数,超声外科器械能够基本上同时进行组织的切割和通过凝固的止血,以有利地使患者创伤最小化。切割动作通常通过在器械远侧端部处的端部执行器或刀头来完成,该端部执行器将超声能量传输到接触端部执行器的组织。具有这一性质的超声器械可以被构造用于开放性外科手术用途、腹腔镜式或内窥镜式外科规程,包括机器人辅助规程。
一些外科器械将超声能量同时用于精确切割和受控凝固。超声能量通过振动与组织接触的刀来进行切割和凝固。通过高频振动(如每秒55,500次),超声刀使组织中的蛋白变性,以形成粘性凝固物。刀片表面施加于组织上的压力使血管收缩并允许所述凝固物形成止血密封。切割和凝固的精度受外科医生的技术以及对功率电平、刀刃、组织牵引力和刀片压力的调节的控制。
用于将电能施加到组织以治疗和/或破坏组织的电外科装置也在外科手术中得到日益广泛的应用。电外科装置通常包括手持件、具有远侧安装的端部执行器(例如,一个或多个电极)的器械。所述端部执行器可抵靠组织定位,使得电流被引入组织中。电外科装置能够被构造成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,并通过返回电极(例如,接地垫)返回,该有源电极与该返回电极分开位于患者的身体上。流过组织的电流所产生的热可在组织内和/或在组织之间形成止血密封,并因此可尤其适用于例如密封血管。电外科装置的端部执行器也可包括能够相对于组织运动的切割构件以及用以横切组织的电极。
由电外科装置施加的电能可通过与手持件连通的发生器输送至器械。电能可以是射频(“RF”)能量的形式。RF能量为可在200千赫兹(kHz)至1兆赫兹(MHz)频率范围内的电能形式。在应用中,电外科装置可穿过组织输送低频射频能,这会引起离子振荡或摩擦,并实际上造成电阻性加热,从而升高组织的温度。由于受影响的组织与周围组织之间形成明显的边界,因此外科医生能够以高精确度进行操作,并在不损伤相邻的非目标组织的情况下进行控制。射频能的低操作温度适用于在密封血管的同时移除、收缩软组织、或对软组织塑型。RF能量尤其奏效地适用于主要由胶原构成并且在接触热时收缩的结缔组织。
RF能量可在EN 60601-2-2:2009+A11:2011,定义201.3.218-高频率中所述的频率范围内。例如,单极RF应用中的频率通常可被限制为小于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200kHz以上的频率,以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,则双极应用可使用较低频率。通常,不使用5MHz以上的频率以最小化与高频渗漏电流相关联的问题。然而,在双极应用的情况下,可使用较高的频率。通常认为,10mA是组织热效应的下限阈值。
使用这些医疗装置的挑战在于不能根据正由装置处理的组织的类型来控制和定制功率输出。期望提供一种克服当前器械的某些缺陷的外科器械。本文所述的外科系统能够克服这些缺陷。
发明内容
根据本申请的各个方面,在组织治疗期间,可将参数化的组织模型拟合到组织。存在于模型中的参数可用于实时地生成最佳控制器,也可以与特定组织特征相关。本申请提供了基于RF阻抗和实时组织评估的对发生器控制系统的实时优化。
根据本申请的各个方面,可以使用系统识别方法来实时地构建组织模型,并且实时地开发针对特定组织类型的控制器,以使密封最大化,并使组织粘连和循环时间最小化。此外,提供了在密封和切割循环期间,基于组织特性和组织中的变化,来控制外科器械的输出这一手段。
根据一个方面,外科器械使用RF能量模式来感测组织特性(诸如阻抗)以及组织特性的变化,以调制超声组织处理系统的输出功率。具体地讲,外科器械的输出功率可以为期望的阻抗轨迹的函数来调制,其中该阻抗轨迹带来了期望的组织效应或结果。在一个方面,RF输出可以是治疗性的,例如组织治疗或亚治疗性的(例如仅感测)。Rf输出可被施加到组织,并且电压和电流、或者电压和电流的表示受到测量或估计。可以通过确定电压与电流的比例来计算阻抗。
另外,已知RF阻抗在组织的加热和凝固期间会发生改变。Rf阻抗可以用作组织状态的指标,因此可以用来指示在凝血周期、血管密封周期,切割等方面的进程。如果输出被调制为使得RF阻抗遵循特定且期望的阻抗变化过程,则可以拓展使用RF阻抗的这种变化来形成期望的治疗循环。可以基于器械的操作参数来预先确定期望的阻抗过程,或者通过外科医生的选择或组织参数的测量以设定该治疗过程以确定期望的阻抗过程。阻抗过程可以确定下述一者或多者:输出功率、输出波形或波形、对能量模式或模态的选择、或终止向组织施加能量的点。
在一个方面中,公开了一种外科能量发生器系统,该系统包括超声输出级,该超声输出级被构造成能够驱动联接到外科器械的组织治疗部分的换能器,其中该组织治疗部分将振动能量施加到组织以影响该组织的治疗,并且该组织治疗部分的振动幅度由控制器控制;RF输出级,该RF输出级被构造成能够经由至少一个电极向组织提供电外科能量,所述至少一个电极被构造成能够将电外科能量施加到组织;感测电路,该感测电路被构造成能够测量组织的阻抗;以及控制器,该控制器被编程为根据阻抗值和预定的阻抗上升来确定是否已发生组织反应,其中该组织反应对应于组织液的沸点,以基于该组织反应确定情况,生成目标阻抗轨迹,该生成目标阻抗轨迹为所测得的阻抗和预定的阻抗改变速率的函数,其中目标阻抗轨迹包括用于多个时间步长中的每个时间步长的多个目标阻抗值,并且通过调整超声输出级的输出水平,而随目标阻抗轨迹来驱动组织阻抗,使组织阻抗与相应的目标阻抗值在至少预定的最小时间段内基本上相匹配。
除上述内容之外,在诸如本公开的文本(例如,权利要求和/或具体实施方式)和/或附图的教导内容中列出和描述了各种其他方法和/或系统和/或程序产品方面。
上述内容是概述,因此可包括简化、概括、纳入部分和/或细节的省略;因此,本领域技术人员应当理解,该概述仅仅是说明性的,并不旨在以任何方式进行限制。本文描述的设备和/或过程和/或其他主题的其他方面、特征和优点将在本文列出的教导内容中变得显而易见。
在各方面中的一个或多个方面,相关系统包括但不限于用于执行本文引用的方法方面的电路和/或编程;电路和/或编程实际上可以是被构造成能够根据系统设计者的设计选择来影响本文引用的方法方面的硬件、软件和/或固件的任意组合。除上述内容之外,在诸如本公开的文本(例如,权利要求和/或具体实施方式)和/或附图的教导中列出和描述了各种其他方法和/或系统方面。
此外,应当理解,下述形式、形式表达、示例中的任何一个或多个可与下述其它形式、形式表达和示例中的任何一个或多个组合。
前面的概述仅仅是说明性的,并不意图以任何方式进行限制。除了上述的说明性方面、实施例和特征结构,通过参照附图和以下详细描述,本发明的其他方面、实施例和特征结构将变得显而易见。
附图说明
所述形式的新型特征结构在随附权利要求书中具体阐述。然而,关于组织和操作方法的所述形式可通过结合附图参照以下描述最好地理解,其中:
图1示出了包括发生器和可与发生器一起使用的各种外科器械的外科系统的一个方面;
图2是图16的超声外科器械的一个方面的图;
图3是图16的外科系统的一个方面的图;
图4是示出了动态支路电流的一个方面的模型;
图5是发生器架构的一个方面的结构视图;
图6示出了发生器的驱动系统的一个方面,该驱动系统形成用于驱动超声换能器的超声电信号;
图7示出了包括组织阻抗模块的发生器的驱动系统的一个方面;
图8示出了用于将多种能量模态传送到外科器械的发生器的一个方面;
图9是来自发生器的一个方面的两个能量波形的示例曲线图;
图10是图9的波形之和的示例曲线图;
图11是图9的波形之和的示例曲线图,其中RF波形取决于超声波波形;
图12是图9的波形之和的示例曲线图,其中RF波形是超声波波形的函数;
图13是复合RF波形的示例曲线图;
图14示出了包括位于夹持臂上的RF数据传感器的端部执行器的一个方面;
图15示出了图14所示的柔性电路的一个方面,其中传感器可以安装到该柔性电路或与其整体地形成;
图16是图15所示的柔性电路的剖视图;
图17示出了被构造成能够固定地附接至端部执行器的夹持臂的分段柔性电路的一个方面;
图18示出了被构造成能够安装到端部执行器的夹持臂的分段柔性电路的一个方面;
图19示出了被构造成能够测量组织间隙GT的端部执行器的一个方面;
图20示出了左右分段柔性电路的一个方面;
图21示出了包括如图20所示的分段柔性电路的端部执行器的一个方面;
图22示出了图21所示的端部执行器,其中夹持臂将组织夹持在夹持臂和超声刀之间;
图23示出了基于局部感测的组织参数由端部执行器的右侧和左侧施加的能量的曲线图;
图24示出了描绘根据诸如连续性、温度、压力等的辅助组织参数的测量所进行的阈值调节的一个方面的曲线图;
图25是包括嵌入其中的RF电极和数据传感器的柔性电路的一个方面的剖视图;
图26是被构造成能够感测施加到位于夹持臂与超声刀之间的组织的力或压力的端部执行器的一个方面的剖视图;
图27是柔性电路的信号层的一个方面的示意图;
图28是用于图27所示的柔性电路的传感器布线的示意图;
图29是RF能量驱动电路的一个方面的示意图;
图30是在预设时间测量组织间隙的图形表示;
图31是用于针对薄的、中等的和厚的组织类型预设的力与时间关系的时间图;
图32是三条曲线的曲线图的图形描绘,其中第一曲线代表功率(P)、电压(VRF)和电流(IRF)与组织阻抗(Z)的关系,第二曲线和第三曲线代表组织阻抗(Z)与时间(t)的关系;
图33是端部执行器的一个方面的平面图;
图34是图33所示的端部执行器的侧视图,其具有局部剖面图以暴露出夹持臂和超声刀的底层结构;
图35是图33、图34所示的端部执行器的局部剖视图,以分别暴露出超声刀和左右电极;
图36是在图33中所示的端部执行器的截面36--36截取的剖视图;
图37是在图33中所示的端部执行器的截面37--37截取的剖视图;
图38是在图33中所示的端部执行器的截面36--36截取的剖视图,不同之处在于超声刀具有不同的几何构型;
图39是在图33中所示的端部执行器的截面37--37截取的剖视图,不同之处在于超声刀具有不同的几何构型;
图40是在图33中所示的端部执行器的截面36--36截取的剖视图,不同之处在于超声刀具有不同的几何构型;
图41是在图33中所示的端部执行器的截面37--37截取的剖视图,不同之处在于超声刀具有不同的几何构型;
图42A是围绕组织的医疗装置的一个方面的图形表示;
图42B是压缩组织的医疗装置的一个方面的图形表示;
图43A是压缩组织的医疗装置的一个方面的图形表示;
图43B还描绘了由压缩组织的医疗装置的端部执行器的一个方面施加的示例性力;
图44示出了反馈系统的一个方面的逻辑流程图;
图45是示出了RF阻抗与使用RF能量实现适当组织密封的组织阻抗时间的关系的示例曲线图;
图46是RF阻抗与组织阻抗时间的关系的图形表示,其中使用组织模型和实验数据的下坡单纯形技术将40W的RF功率传送到组织;
图47是使用线性二次控制器(LQR)的RF阻抗与组织阻抗时间的关系的图形表示,其中对于组织和实验数据模型,对在组织阻抗等于250欧姆的情况下实现稳态具有预补偿;
图48是使用线性二次控制器(LQR)的RF阻抗与组织阻抗时间的关系的图形表示,其中对于组织和实验数据模型,对在组织阻抗以50欧姆/秒的速率上升的情况下实现稳态具有预补偿;
图49是用于识别组织类型并开发控制过程以根据组织阻抗来控制将能量模态应用于组织这一操作的方法的逻辑流程图。
图50是根据本公开一个方面的基于组织阻抗来治疗组织的方法的逻辑流程图。
具体实施方式
在详细说明外科器械的各种形式之前,应该指出的是,示例性形式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配置和布置的细节。示例性形式可以单独实施,也可以与其它形式、变型和修改结合在一起实施,并可以通过多种方式实践或执行。此外,除非另外指明,否则本文所用的术语和表达是为了方便读者而对示例性形式进行描述目的所选的,并非为了限制性的目的。
此外,应当理解,下述形式、形式表达、示例中的任何一个或多个可与下述其它形式、形式表达和示例中的任何一个或多个组合。
各种形式均涉及被构造成能够在外科规程中执行组织解剖、切割和/或凝固的改进的超声外科器械和/或电外科(RF)器械。在一种形式中,组合的超声和电外科器械能被构造成能够用于开放式外科手术中,但也可应用于其他类型的手术中,诸如腹腔镜式、内窥镜式和机器人辅助手术。超声和RF能量的选择性使用有利于实现多种用途。
将结合本文所述的超声器械描述各种形式。此类说明以举例而非限制性的方式提供,并且不旨在限制其范围和应用。例如,所述形式中的任一者均可与多个超声器械结合使用,该超声器械包括在例如美国专利No.5,938,633、No.5,935,144、No.5,944,737、No.5,322,055、No.5,630,420和No.5,449,370中所述的那些。
通过以下说明将变得显而易见的是,设想本文所述的外科器械的形式可与外科系统的振荡器单元相联地使用,由此振荡器单元的超声能量为当前的外科器械提供期望的超声致动。还设想,本文所述的外科器械的形式可与外科系统的信号发生器单元相联地使用,由此例如射频(RF)形式的电能被用来为与外科器械有关的用户提供反馈。超声振荡器和/或信号发生器单元可与外科器械不可拆卸地一体化,或者能作为能以电的方式附接到外科器械的单独部件提供。
本外科设备的一种形式由于其简单构造而被特别构造用于一次性使用。然而,还设想本外科器械的其它形式可能够用于非一次性或多次使用。仅出于说明性目的,当前公开了用于单个患者使用的本发明的外科器械与相关联的振荡器和信号发生器单元的可拆卸连接。然而,还设想了本发明的外科器械与相关联的振荡器和/或信号发生器单元的不可拆卸的一体式连接。因此,当前所述的外科器械的各种形式可能够用于与可拆卸的和/或不可拆卸的一体化振荡器和/或信号发生器单元一起用于单次使用和/或多次使用,然而并非仅限于此,而是这些构型的所有组合均被设想为落入本公开的范围内。
本文所公开的外科器械涉及以下共同拥有并与本申请同时提交的申请中描述的外科器械:Yates等人的标题为“Surgical System With User Adaptable Techniques”的END7747USNP、Stulen等人的标题为“Surgical System With User AdaptableTechniques”的END7747USNP1、Wiener等人的标题为“Surgical System With UserAdaptable Techniques Employing Multiple Energy Modalities Based On TissueParameters”的END7747USNP2,以及Yates等人的标题为“Surgical System With UserAdaptable Techniques Employing Simultaneous Energy Modalities Based On TissueParameters”的END7747USNP4,其中每个文献全文以引用方式并入本文中。
参照图1至图5,其示出了包括超声外科器械的外科系统10的一种形式。图1示出了包括发生器102以及可与其一起使用的各种外科器械104,106,108的外科系统100的一种形式。图2是图1的超声外科器械104的图。
图1示出了被构造成能够驱动多个外科器械104,106,108的发生器102。第一外科器械104包括手持件105、超声换能器120、轴126和端部执行器122。端部执行器122包括声学地联接到换能器120的超声刀128和夹持臂140。手持件105包括用于操作夹持臂140的触发器143以及用于给超声刀128供能和驱动该超声刀或其他功能的切换钮134a,134b,134c的组合。切换钮134a,134b,134c可以被构造成能够利用发生器102给超声换能器120供能。
仍参照图1,发生器102还被构造成能够驱动第二外科器械106。第二外科器械106是RF电外科器械,并且包括手持件107、轴127和端部执行器124。端部执行器124包括夹持臂143中的电极并通过超声刀149返回。这些电极联接到发生器102内的双极能量源并由其供能。手持件107包括用于操作夹持臂145的触发器147和用于致动能量开关以给端部执行器124中的电极供能的能量按钮135。
仍参照图1,发生器102还被构造成能够驱动电外科和超声组合器械108。电外科和超声组合多功能外科器械108包括手持件109、轴129和端部执行器125。端部执行器包括超声刀149和夹持臂145。超声刀149声学地联接到超声换能器120。手持件109包括用于操作夹持臂145的触发器147以及用于以给超声刀149供能和驱动该超声刀或其他功能的切换钮137a,137b,137c的组合。切换按137a,137b,137c可以被构造成能够为利用发生器102给超声换能器120供能,并且利用同样容纳在发生器102内的双极能量源给超声刀149供能。
参照图1和图2,发生器102被构造成能够与各种外科装置一起使用。根据各种形式,发生器102可以被构造成能够与不同类型的不同外科装置一起使用,该外科装置包括例如超声外科器械104、电外科或RF外科装置(诸如RF电外科器械106)以及集成了从发生器102同时传送的电外科RF能量和超声能量的多功能外科器械108。尽管在图1所示的形式中,发生器102被显示为与外科器械104,106,108分开,然而在一种形式中,发生器102可与外科器械104,106,108中的任一者整体地形成,以形成一体式外科系统。发生器102包括位于发生器102控制台的前面板上的输入装置110。输入装置110可包括生成适于对发生器102的操作进行编程的信号的任何合适的装置。发生器102还可包括一个或多个输出装置112。
发生器102经由缆线144联接到超声换能器120。超声换能器120和延伸穿过轴126的波导(图2中未示出的波导)可集体形成驱动端部执行器122的超声刀128的超声驱动系统。端部执行器122还可包括夹持臂140,用于将组织夹持在夹持臂140和超声刀128之间在一种形式中,发生器102可以被构造成能够生成特定电压、电流和/或频率输出信号的驱动信号,所述驱动信号可阶跃或以其他方式修改为具有高分辨率、精度和再现性。
仍参照图2,应当理解,外科器械104可包括切换钮134a,134b,134c的任意组合。例如,外科器械104能被构造成能够具有仅两个切换钮:切换钮134a和切换钮134c,切换钮134a用于产生最大超声能量输出,切换钮134c用于产生最大或小于最大功率电平的脉冲输出。这样,发生器102的驱动信号输出构型可为5个连续信号和5或4或3或2或1个脉冲信号。在某些形式中,例如可基于发生器102中的EEPROM设定和/或用户功率电平选择来控制特定的驱动信号配置。
在某些形式中,可提供双位开关来替代切换钮134c。例如,外科器械104可包括用于产生最大功率电平的连续输出的切换钮134a和双位切换钮134b。在第一止动位置中,切换钮134b可产生小于最大功率电平的连续输出,并且在第二止动位置中,切换钮134b可产生脉冲输出(例如,根据EEPROM设定而定,具有最大功率电平或小于最大功率电平)。
仍参照图2,发生器102的形式可实现与基于器械的数据电路的通信。例如,发生器102可以被构造成能够与第一数据电路136和/或第二数据电路138连通。例如,第一数据电路136可指示老化频率斜率,如本文所述。除此之外或另选地,任何类型的信息均可经由数据电路接口(例如,使用逻辑装置)连通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。在某些形式中,第二数据电路可传输由一个或多个传感器(例如,基于器械的温度传感器)采集的数据。在某些形式中,第二数据电路可从发生器102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)。第二数据电路138包含在外科装置的多功能外科器械108中。在一些形式中,第二数据电路138可以类似于本文所述的第一数据电路136的方式实施。器械接口电路可包括用于实现此种连通的第二数据电路接口。在一种形式中,第二数据电路接口可包括三态数字接口,然而也可使用其他接口。在某些形式中,第二数据电路通常可为用于传输和/或接收数据的任何电路。在一种形式中,例如第二数据电路可存储与相联的特定外科器械相关的信息。此类信息例如可包括型号、序列号、其中使用外科器械的操作数目和/或任何其他类型的信息。在一些形式中,第二数据电路138可存储关于相关联的换能器120、端部执行器122或超声驱动系统的电性能和/或超声性能信息。本文所述的各种过程和技术可由发生器执行。然而,应当理解,在某些示例性形式中,这些过程和方法的全部或部分可由多功能外科器械108的内部逻辑139执行。
图3为图1所示外科系统100的图。在各种形式中,发生器102可包括诸如模块和/或区块的多个单独的功能性元件。不同的功能性元件或模块可以被构造成能够驱动不同种类的外科器械104,106,108。例如,超声发生器驱动电路114可经由缆线142驱动超声装置,诸如超声外科器械104。电外科/RF发生器驱动电路116可经由缆线144驱动电外科器械106。例如,相应的驱动电路114,116可生成用于驱动外科器械104,106,108的相应的驱动信号。在各种形式中,超声发生器驱动电路114(例如,超声驱动电路)和/或电外科/RF发生器驱动电路116(例如,RF驱动电路)各自可与发生器102整体地形成。另选地,驱动电路114,116中的一者或多者可作为电联接到发生器102的单独的电路模块提供。(驱动电路114和116以虚线显示以示出该选项。)此外,在一些形式中,电外科/RF发生器驱动电路116可与超声发生器驱动电路114整体地形成,或反之亦然。此外,在一些形式中,发生器102可被完全省略并且驱动电路114,116可由相应外科器械104,106,108内的处理器或其他硬件来执行。
在其他形式中,超声发生器驱动电路114和电外科/RF发生器驱动电路116的电输出可组合成单个驱动电路,以提供能够经由缆线146同时驱动多功能外科器械108与电外科RF和超声能量的单个电信号。多功能外科器械108包括联接到超声刀149的超声换能器120以及端部执行器124中的一个或多个电极,以接收电外科RF能量。在此类具体实施中,组合的RF/超声信号联接到多功能外科器械108。多功能外科器械108包括信号处理部件,以将组合的RF/超声信号分离,使得RF信号可被传送到端部执行器124中的电极,并且超声信号可被传送到超声换能器120。
根据所述形式,超声发生器驱动电路114可产生特定电压、电流和频率例如55500周每秒(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到超声外科器械104,以及具体地到可例如如本文所述进行操作的换能器120。换能器120和延伸穿过轴126的波导(图2中未示出的波导)可集体形成驱动端部执行器122的超声刀128的超声驱动系统。在一种形式中,发生器102可以被构造成能够生成特定电压、电流和/或频率输出信号的驱动信号,所述驱动信号可阶跃或以其他方式修改为具有高分辨率、精度和再现性。
发生器102可被启动以按任何合适的方式将驱动信号提供至换能器120。例如,发生器102可包括经由脚踏开关缆线132联接到发生器102的脚踏开关130。临床医生可通过压下脚踏开关130来启动换能器120。此外,或作为脚踏开关130的替代,超声外科器械104的一些形式可利用定位在手持件上的一个或多个开关,当该一个或多个开关被致动时可促使发生器102致动换能器120。在一种形式中,例如,该一个或多个开关可包括一对切换钮134a,134b(图2)例如以确定外科器械104的操作模式。例如,当切换钮134a被压下时,超声发生器102可向换能器120提供最大驱动信号,以使换能器产生最大超声能量输出。压下切换钮134b可促使超声发生器102向换能器120提供用户可选的驱动信号,以使换能器产生小于最大值的超声能量输出。除此之外或另选地,外科器械104可包括第二开关(未示出)以例如指示用于操作端部执行器122的钳口的钳口闭合触发器的位置。此外,在一些形式中,超声发生器102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闭合钳口时,可施加超声能量)。
除此之外或另选地,该一个或多个开关可包括切换钮134c,当该切换钮被压下时,致使发生器102提供脉冲输出。脉冲例如可按任何合适的频率和分组提供。在某些形式中,例如,脉冲的功率电平可为与切换钮134a,134b相关联的功率电平(最大值、小于最大值)。
根据所述形式,电外科/RF发生器驱动电路116可生成具有足以使用射频(RF)能量执行双极性电外科手术的输出功率的一个或多个驱动信号。例如,在双极性电外科应用中,驱动信号可被提供至例如电外科器械106的电极。因此,发生器102可以被构造成能够通过将足以处理组织(例如,凝固、烧灼、组织焊接)的电能施加到组织而达到治疗目的。
发生器102可包括位于例如发生器102控制台的前面板上的输入装置110(图1)。输入装置110可包括生成适于对发生器102的操作进行编程的信号的任何合适的装置。在操作中,使用者可使用输入装置110对发生器102的操作进行编程或以其他方式进行控制。输入装置110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102的操作(例如,超声发生器驱动电路114和/或电外科/RF发生器驱动电路116的操作)的信号的任何合适的装置。在各种形式中,输入装置110包括远程连接至通用或专用计算机的钮、开关、指轮、键盘、小键盘、触摸屏监测器、指向装置中的一者或多者。在其他形式中,例如,输入装置110可包括合适的用户界面,例如显示于触摸屏显示器上的一个或多个用户界面屏幕。因此,通过输入装置110,用户可设定或编程发生器的各种操作参数,例如由超声发生器驱动电路114和/或电外科/RF发生器驱动电路116所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102还可包括位于例如发生器102控制台的前面板上的输出装置112(图1、图3),诸如输出指示器。输出装置112包括一个或多个用于为使用者提供感观反馈的装置。此类装置可包括例如视觉反馈装置(例如,视觉反馈装置可包括白炽灯、发光二极管(LED)、图形用户界面、显示器、模拟指示器、数字指示器、条形图显示器、数字字母混合显示器、LCD显示屏幕、LED指示器)、音频反馈装置(例如,音频反馈装置可包括扬声器、蜂鸣器、可听见的计算机产生的音调、经计算机处理的语言、通过语音/语言平台与计算机相互作用的语音用户界面(VUI))或者触觉反馈装置(例如,触觉反馈装置包括任何类型的振动反馈、触觉致动器)。
尽管可以举例的方式描述发生器102的某些模块、电路和/或区块,但可理解,可使用更多或更少数目的模块、电路和/或区块,并且仍落入所述形式的范围内。此外,尽管为了便于说明可根据模块、电路和/或区块来描述各种形式,然而此类模块、电路和/或区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、子程序、逻辑)和/或硬件部件和软件部件的组合来实施。此外,在一些形式中,本文所述的各种模块可利用位于外科器械104,106,108内的相似硬件来实施(即,发生器102可被省略)。
在一种形式中,超声发生器驱动电路114和电外科/RF驱动电路116可包括作为固件、软件、硬件或其任意组合实施的一个或多个嵌入式应用程序。驱动电路114,116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。该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中可保护闪速存储器。NVM可包括其他类型的存储器,包括(例如)可编程ROM(PROM)、可擦除可编程ROM(EPROM)、电可擦除可编程ROM(EEPROM)或电池支持的随机存取存储器(RAM)(诸如动态RAM(DRAM)、双数据率DRAM(DDRAM)和/或同步DRAM(SDRAM))。
在一种形式中,驱动电路114,116包括硬件组件,所述硬件组件被实施成用于执行程序指令的处理器,以用于监测外科器械104,106,108的各种可测量特性并生成用于操作外科器械104,106,108的对应输出控制信号。在其中发生器102与外科器械104结合使用的形式中,输出控制信号可在切割和/或凝固操作模式下驱动超声换能器120。外科器械104和/或组织的电特性可被测量并且用于控制发生器102的操作方面和/或作为反馈提供给用户。在其中发生器102与电外科器械106结合使用的形式中,输出控制信号可在切割、凝固和/或脱水模式下向端部执行器124提供电能(例如,RF能量)。电外科器械106和/或组织的电特性可被测量并且用于控制发生器102的操作方面和/或向用户提供反馈。在各种形式中,如在前所述,硬件部件可作为DSP、PLD、ASIC、电路和/或寄存器实施。在一种形式中,处理器可被构造成能够存储和执行计算机软件程序指令,以生成用于驱动外科器械104,106,108的各种部件(诸如超声换能器120和端部执行器122,124)的输出信号功能。
图4示出根据一种形式的超声换能器诸如图1至图3所示的超声换能器120的等效电路150。电路150包括第一“动生”支路和第二电容支路,该第一“动生”支路具有限定谐振器的机电性能的串联连接的电感Ls、电阻Rs和电容Cs,该第二电容支路具有静电电容Co。驱动电流Ig可在驱动电压Vg下从发生器接收,其中动生电流Im流过第一支路,并且电流Ig至Im流过电容支路。可通过合适地控制Ig和Vg来实现对超声换能器的机电性能的控制。如上所述,传统发生器架构可包括调谐电感器Lt(在图4中以虚线显示),以用于在并联谐振电路中将静电电容Co调谐成谐振频率,使得基本上所有发生器的电流输出Ig全部流过动生支路。这样,通过控制发生器电流输出Ig来实现对动生支路电流Im的控制。然而,调谐电感器Lt对超声换能器的静电电容Co是特定的,并且具有不同静电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在一个谐振频率下与静电电容Co的标称值相匹配,所以仅在该频率下才能确保对动生分支电流Im的精确控制,并且当频率随换能器温度向下偏移时,对动生支路电流的精确控制会受损。
图1至图3所示的发生器102的形式并不依赖于调谐电感器Lt来监视动态支路电流Im。相反,发生器102可在用于特定超声外科器械104的功率的应用(连同驱动信号电压和电流反馈数据)之间使用静电电容Co的测量值,以在动态和持续进行的基础上(例如,实时)确定动生支路电流Im的值。因此,此类形式的发生器102能够提供虚拟调谐,以模拟在任何频率下而不只在静电电容Co的标称值所指示的谐振频率下与任何静电电容Co值调谐或谐振的系统。
图5是发生器200的简化框图,该发生器是图1至图3所示的发生器102的一种形式,用于如本文所述除提供其他有益效果之外还提供无电感器调谐。发生器102的其他细节在共同分配并同时提交的题为“Surgical Generator For Ultrasonic AndElectrosurgical Devices”且代理档案号为END6673USNP/100558的美国专利申请No.12/896,360中有所描述,该专利申请的公开内容全文以引用方式并入本文。参照图5,发生器200可包括经由功率变压器206与非隔离台204通信的患者隔离台202。功率变压器206的次线圈208包含在隔离台202中并且可包括分接构型(例如,中心分接或非中心分接构型)来限定驱动信号输出210a,210b,210c,以将驱动信号输出至不同外科装置(例如,超声外科器械104和电外科器械106(如图1至图3所示)。具体地讲,驱动信号输出210a,210c可将超声驱动信号(例如,420V RMS驱动信号)输出至超声外科器械104,而驱动信号输出210b,210c可将电外科RF驱动信号(例如,100V RMS驱动信号)输出至电外科器械106,其中输出210b对应于功率变压器206的中心抽头。
在某些形式中,超声驱动信号和电外科驱动信号可同时提供至不同的外科器械和/或具有将超声能量和电外科能量两者传送到组织的能力的单个外科器械,诸如多功能外科器械108(图1和图3)。应当理解,提供至专用电外科器械和/或提供至组合多功能超声/电外科器械的电外科信号可以是治疗电平信号或亚治疗电平信号。例如,超声信号和射频信号可从具有单个输出端口的发生器单独地或同时传送,以便向外科器械提供期望的输出信号,如将在下文更详细地讨论。因此,发生器可组合超声能量和电外科RF能量并且将组合的能量传送到多功能超声/电外科器械。双极电极可被放置在端部执行器的一个或两个钳口上。除了电外科RF能量之外,一个钳口可被超声能量同时驱动。超声能量可用于解剖组织,而电外科RF能量可用于脉管密封。
非隔离台204可包括功率放大器212,所述功率放大器具有连接到功率变压器206的主线圈214的输出。在某些形式中,功率放大器212可包括推挽放大器。例如,非隔离台204还可包括逻辑装置216,以用于向数模转换器(DAC)218提供数字输出,而该数模转换器(DAC)又将对应的模拟信号提供至功率放大器212的输入端。在某些形式中,例如除其他逻辑电路之外,逻辑装置216还可包括可编程的门阵列(PGA)、现场可编程的门阵列(FPGA)、可编程的逻辑装置(PLD)。因此,由于经由DAC 218控制功率放大器212的输入,逻辑装置216可控制在驱动信号输出210a,210b,210c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。在某些形式中,如下所述,逻辑装置216结合处理器(例如,下文所述的数字信号处理器)可实施多个基于数字信号处理(DSP)的技术和/或其他控制技术,以控制发生器200所输出的驱动信号的参数。
可通过开关模式调节器220将功率提供至功率放大器212的功率轨。某些形式中,开关模式调节器220例如可包括可调式降压调节器。例如,非隔离台204还可包括第一处理器DSP处理器222,在一种形式中,可包括DSP处理器,诸如购自Analog Devices,Norwood,MA的Analog Devices ADSP-21469SHARC DSP,但可在各种形式中采用任何合适的处理器。在某些形式中,DSP处理器222可响应于由DSP处理器222经由模数转换器(ADC)224从功率放大器212接收的电压反馈数据来控制开关模式功率转换器220的操作。在一种形式中,例如,DSP处理器222可接收经由ADC 224由功率放大器212放大的信号(例如,RF信号)的波形包络作为输入。然后,DSP处理器222可控制开关模式调节器220(例如,经由脉宽调制(PWM)输出),使得提供给功率放大器212的导轨电压跟踪放大的信号的波形包络。通过基于波形包络动态调制功率放大器212的导轨电压,功率放大器212的效率相对于固定导轨电压放大器方案可显著升高。
在某些形式中,逻辑装置216结合DSP处理器222可实施直接数字合成器(DDS)控制方案,以控制发生器200所输出驱动信号的波形形状、频率和/或振幅。在一种形式中,例如,逻辑装置216可通过召回存储在动态更新的查找表(LUT)(诸如RAM LUT)中的波形样本来实施DDS控制技术,该动态更新的查找表可被嵌入在FPGA中。此种控制技术尤其适用于其中在其谐振频率下可通过完全正弦电流驱动超声换能器诸如超声换能器120(图1至图3)的超声应用。因为其他频率可激发寄生谐振,所以最小化或减小动生支路电流的总失真可相应地最小化或减小不可取的谐振效应。因为发生器200所输出的驱动信号的波形形状受输出驱动电路(例如,功率变压器206、功率放大器212)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到技术(诸如由DSP处理器222实施的误差控制技术)中,该技术在动态持续的基础上(例如,实时)通过适当地预失真或修改存储在LUT中的波形样本来补偿失真。在一种形式中,对LUT样本所施加的预先畸变量或程度可根据所计算的动态支路电流与期望的电流波形形状之间的误差而定,其中所述误差可基于逐一样本地确定。这样,预失真的LUT样本在被处理穿过驱动电路时,可使动生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,在此类形式中,当考虑到畸变效应时,LUT波形样本将不呈现驱动信号的期望波形形状,而是呈现要求最终产生动态支路驱动信号的期望波形形状的波形形状。
非隔离台204还可包括经由相应的隔离变压器230,232联接到功率变压器206的输出的ADC 226和ADC 228,以分别用于对发生器200所输出的驱动信号的电压和电流进行采样。在某些形式中,ADC 226,228可被构造成能够以高速(例如,80MSPS)进行采样,以能够对驱动信号进行过采样。在一种形式中,例如ADC 226,228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。在某些形式中,可通过令单个ADC经由二路式多路复用器接收输入电压和电流信号来执行ADC 226,228的采样操作。通过在发生器200的形式中使用高速采样,除别的之外,还可实现对流过动生支路的复杂电流的计算(这在某些形式中可用于实施本文所述的基于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 226,228所输出的电压和电流反馈数据可由逻辑装置216接收并处理(例如,FIFO缓冲、多路复用),并且被存储在数据存储器中,以供例如DSP处理器222后续检索。如上所述,电压和电流反馈数据可用作至技术的输入,以用于在动态持续的基础上预失真或修改LUT波形样本。在某些形式中,当采集到电压和电流反馈数据对时,可能需要基于由逻辑装置216输出的对应LUT样本或以其他方式与该对应LUT样本相关联来对每个存储的电压和电流反馈数据对进行索引。这样使LUT样本与电压和电流反馈数据同步有助于预失真技术的正确定时和稳定性。
在某些形式中,可使用电压和电流反馈数据来控制驱动信号的频率和/或振幅(例如,电流振幅)。在一种形式中,例如,可使用电压和电流反馈数据来确定阻抗相位。然后,可控制驱动信号的频率以最小化或减小所确定的阻抗相位与阻抗相位设定点(例如,0°)之间的差值,从而最小化或减小超声失真的影响并相应地提高阻抗相位测量结果的精确度。相位阻抗和频率控制信号的确定可在DSP处理器222中实现,例如,其中频率控制信号作为输入被提供至逻辑装置216所实施的DDS控制算法。
在另一形式中,例如可监视电流反馈数据,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。在某些形式中,例如可通过DSP处理器222中的控制技术(例如,PID控制技术)来实现对电流振幅的控制。由控制技术控制以适当地控制驱动信号的电流幅值的变量可包括:例如,存储在逻辑装置216中的LUT波形样本的标度和/或经由DAC 234的DAC 218(其将输入提供给功率放大器212)的满标度输出电压。
非隔离台204还可包括第二处理器诸如UI处理器236,以用于除别的之外还提供用户界面(UI)功能。在一种形式中,UI处理器236可包括例如购自Atmel Corporation,SanJose,CA的具有ARM 926EJ-S核的Atmel AT91SAM9263处理器。例如,UI处理器236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130的通信、与输入装置118(例如,触摸屏显示器)的通信、以及与输出装置112(例如,扬声器)的通信,如图3所示。UI处理器236可(例如,经由串行外围接口(SPI)总线)与DSP处理器222和逻辑装置216通信。尽管UI处理器236可主要支持UI功能,然而在某些形式中,其也可与DSP处理器222配合以减缓风险。例如,UI处理器236可被编程用于监视用户输入和/或其他输入(例如,触摸屏输入、脚踏开关130输入(图3)、温度传感器输入)的各个方面,并且当检测到错误状况时停用发生器200的驱动输出。
在某些形式中,例如DSP处理器222与UI处理器236两者可确定并监视发生器200的操作状态。对于DSP处理器222,发生器200的操作状态可指示例如由DSP处理器222实施的是哪些控制和/或诊断过程。对于UI处理器236,发生器200的操作状态可指示例如呈现给用户的是哪些用户界面元素(例如,显示屏、声音)。相应的DSP处理器和UI处理器222,236可独立地保持发生器200的当前操作状态并且识别和评估当前操作状态的可能转变。DSP处理器222可作为此关系中的主体起作用并且确定何时发生操作状态之间的转变。UI处理器236可察觉到操作状态之间的有效转变并且可证实一个特定的转变是否适当。例如,当DSP处理器222指示UI处理器236转变到一个特定状态时,UI处理器236可验证所要求的转变是否有效。如果UI处理器236确定所要求的状态之间的转变是无效的,则UI处理器236可使发生器200进入故障模式。
非隔离台204还可包括控制器238,以用于监视输入装置110(例如,用于接通和断开发生器200的电容触摸传感器、电容触摸屏,例如,如图1和图3所示)。在某些形式中,控制器238可包括至少一个处理器和/或与UI处理器236通信的其他控制装置。在一种形式中,例如,控制器238可包括被构造成能够监测经由一个或多个电容触摸传感器提供的用户输入的处理器(例如,可购自Atmel的Mega168 8位控制器)。在一种形式中,控制器238可包括触摸屏控制器(例如可购自Atmel的QT5480触摸屏控制器),以控制和管理对来自电容触摸屏的触摸数据的采集。
在某些形式中,当发生器200处于“功率关”状态时,控制器238可继续接收操作功率(例如,通过来自发生器200的电源的线)。这样,控制器238可继续监测输入装置110(例如,位于发生器200的前面板上的电容触摸传感器),以用于接通和断开发生器200。当发生器200处于功率关状态时,如果检测到用户激活“接通/断开”输入装置110,则控制器238可启动电源(例如,启用电源的一个或多个DC/DC电压转换器的操作)。控制器238可因此击发使发生器200转变至“功率开”状态的序列。相反,当发生器200处于功率开状态时,如果检测到“接通/断开”输入装置110的激活,则控制器238可击发使发生器200转变至功率关状态的序列。在某些形式中,例如,控制器238可向处理器236报告“接通/断开”输入装置110的激活,该处理器继而实施所需的过程序列以使发生器200转变至功率关状态。在此类形式中,在建立功率开状态之后控制器238可不具有从发生器200移除功率的独立能力。
在某些形式中,控制器238可使发生器200提供听觉或其他感观反馈,以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序列相关联的其他过程开始之前提供此类警示。
在某些形式中,隔离台202可包括器械接口电路240,例如以在外科装置的控制电路(例如,包括手持件开关的控制电路)与非隔离台204的部件(诸如(例如)可编程逻辑装置216、DSP处理器222和/或UI处理器236)之间提供通信界面。器械接口电路240可经由通信连接件(例如基于红外(IR)的通信连接件)与非隔离台204的部件交换信息,该通信连接件在台202,204之间保持合适程度的电绝缘。例如,可使用由隔离变压器提供动力的低跌落电压调节器为器械接口电路240提供动力,所述隔离变压器从非隔离台204被驱动。
在一种形式中,器械接口电路240可包括与信号调节电路242通信的逻辑装置242(例如,逻辑电路、可编程逻辑电路、PGA、FPGA、PLD)。信号调节电路244可以被构造成能够从逻辑电路242接收周期信号(例如,2kHz的矩形波),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性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200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。控制电路可包括多个开关、电阻器和/或二极管,以修改询问信号的一个或多个特性(例如,幅值、整流),使得控制电路的状态或配置基于该一个或多个特性是唯一可辨别的。在一种形式中,例如信号调节电路244可包括ADC,以用于产生由于询问信号通过控制电路而出现在控制电路输入中的电压信号的样本。随后,逻辑装置242(或非隔离台204的部件)可基于ADC样本来确定控制电路的状态或配置。
在一种形式中,器械接口电路240可包括第一数据电路接口246,以实现逻辑电路242(或器械接口电路240的其他元件)与设置于外科装置中的或换句话讲与外科装置相联的第一数据电路之间的信息交换。在某些形式中,例如第一数据电路136(图2)可设置在整体地附接到外科装置手持件的缆线中,或设置在用于使特定的外科装置类型或模型与发生器200交接的适配器中。第一数据电路136可以任何合适的方式实施且可根据包括(例如)本文关于第一电路136所述的任何合适的协议与发生器通信。在某些形式中,第一数据电路可包括非易失性存储装置,例如电可擦除的可编程的只读存储器(EEPROM)装置。在某些形式中并且再次参见图5,第一数据电路接口246可与逻辑装置242分开实施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242与第一数据电路之间的通信。在其他形式中,第一数据电路接口246与逻辑装置242可以是一体式的。
在某些形式中,第一数据电路136(图2)可存储与相联的特定外科装置相关的信息。此类信息例如可包括型号、序列号、其中使用外科装置的操作数目和/或任何其他类型的信息。该信息可被器械接口电路1098(例如,通过逻辑装置242)读取、被传输至非隔离台204的部件(例如,至逻辑装置216、DSP处理器222和/或UI处理器236),以经由输出装置112(图1和图3)呈现给用户和/或控制发生器200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246(例如,使用逻辑装置242)被发送至第一数据电路136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。
如前所述,外科器械能够从手持件拆下(例如,如图1和图2所示,换能器120和轴126能够从超声外科器械104的手持件105拆下)以促进仪器的可互换性和/或可处置性。在此类情形中,常规发生器的识别所使用特定器械构型和相应地优化控制和诊断过程的能力可受限。然而,从兼容性角度来看,通过对外科装置器械添加可读数据电路解决此问题是有问题的。例如,设计外科装置来保持与缺少必备数据读取功能的发生器的向后兼容可能由于例如不同的信号方案、设计复杂性和成本而不切实际。本文所述器械的形式通过使用数据电路解决这些问题,所述数据电路可经济地实施于现有外科器械中并具有最小的设计变化,以保持外科装置与电流发生器平台的兼容性。
参照图1至图3和图5,另外,发生器200的形式可实现与基于器械的数据电路的通信。例如,发生器200可被构造成能够与包含在超声外科器械104(例如,和/或另一外科器械106,108)的第二数据电路138进行通信。在一些形式中,第二数据电路138可以类似于本文所述的第一数据电路136的方式实施。器械接口电路240可包括用于实现此种连通的第二数据电路接口248。在一种形式中,第二数据电路接口248可包括三态数字接口,然而也可使用其他接口。在某些形式中,第二数据电路通常可为用于传输和/或接收数据的任何电路。在一种形式中,例如第二数据电路可存储与相联的特定外科器械相关的信息。此类信息例如可包括型号、序列号、其中使用外科器械的操作数目和/或任何其他类型的信息。在一些形式中,第二数据电路138可存储关于相关联的换能器120、端部执行器122或超声驱动系统的电性能和/或超声性能信息。例如,第一数据电路136可指示老化频率斜率,如本文所述。除此之外或另选地,任何类型的信息均可经由第二数据电路接口248(例如,使用逻辑装置242)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。在某些形式中,第二数据电路可传输由一个或多个传感器(例如,基于器械的温度传感器)采集的数据。在某些形式中,第二数据电路可从发生器200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)。
在某些形式中,第二数据电路和第二数据电路接口248可被构造成使得可实现逻辑装置242与第二数据电路之间的通信而无需提供用于此目的的附加导体(例如,用于将手持件连接到发生器200的缆线的专用导体)。在一种形式中,例如可使用实施于现有缆线(例如,用于将询问信号从信号调节电路244传输至手持件中的控制电路的其中一个导体)上的单总线通信方案而使信息以通信方式到达和离开第二数据电路。这样,可最小化或减少原本可能必要的外科装置的设计变化或修改。此外,因为在共用物理通道上实施的不同类型的通信可为频带分离的,所以第二数据电路的存在对于不具有必备数据读取功能的发生器而言可为“隐形的”,因此能够实现外科装置器械的向后兼容性。
在某些形式中,隔离台202可包括至少一个阻挡电容器250-1,所述至少一个阻挡电容器连接到驱动信号输出210b以防止DC电流流向患者。例如,可要求信号阻挡电容器符合医疗规则或标准。尽管相对而言单电容器设计中很少出现错误,然而此类错误可造成不良后果。在一种形式中,可设置有与阻挡电容器250-1串联的第二阻挡电容器250-2,其中例如通过ADC 252来监测从阻挡电容器250-1与250-2之间的点发生的电流渗漏,以对渗漏电流所感应的电压进行采样。这些样本例如可由装置242接收。基于渗漏电流的变化(如图5的形式中的电压样本所指示),发生器200可确定阻挡电容器250-1,250-2中的至少一个何时出现故障。因此,图5的形式提供了优于具有单个故障点的单个电容器设计的益处。
在某些形式中,非隔离台204可包括电源254,以用于在适当的电压和电流下输出DC功率。电源可包括例如400W的电源以用于输出48VDC的系统电压。电源254还可包括一个或多个DC/DC电压转换器256,以用于接收电源的输出,以在发生器200的各种部件所需的电压和电流下产生DC输出。如上文结合控制器238所述,当控制器238检测到用户激活“接通/断开”输入装置110(图3)以启用DC/DC电压转换器256的操作或该启动DC/DC电压转换器时,DC/DC电压转换器256中的一者或多者可从控制器238接收输入。
重新参照图1,根据对外科系统100的各种形式的操作细节的描述,通常可就采用包括输入装置110和发生器102的外科器械来切割和凝固组织的过程进一步描述上述外科系统100的操作。虽然结合操作细节描述了具体过程,但可理解,该过程只是提供了外科系统100可如何实施本文所述的一般功能的示例。此外,除非另外指明,否则给定的过程不一定按照本文呈现的次序执行。如前所讨论,可采用输入装置110来编程外科器械104,106,108的输出(例如,阻抗、电流、电压、频率)。
图6示出了根据本公开的一个方面的包括一种形式的驱动系统302的发生器300。发生器300类似于结合图1和图5描述的发生器102,200。发生器300产生用于驱动超声换能器的超声电信号,也称为驱动信号。驱动系统302是柔性的并且可在为驱动超声换能器306而设定的期望的频率和功率电平下生成超声电输出驱动信号304。在各种形式中,发生器300可包括诸如模块和/或区块的多个单独的功能性元件。尽管可通过举例描述某些模块、电路和/或区块,但可理解,可使用更多或更少数目的模块、电路和/或区块,并仍落在所述形式的范围内。此外,尽管为了便于说明可根据模块、电路和/或区块来描述各种形式,然而此类模块、电路和/或区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、子程序、逻辑)和/或硬件部件和软件部件的组合来实施。
在一种形式中,发生器300的驱动系统302可包括作为固件、软件、硬件或它们的任意组合实施的一个或多个嵌入式应用程序。驱动系统302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。该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中可保护闪速存储器。NVM可包括其他类型的存储器,包括(例如)可编程ROM(PROM)、可擦除可编程ROM(EPROM)、电可擦除可编程ROM(EEPROM)或电池支持的随机存取存储器(RAM)(诸如动态RAM(DRAM)、双数据率DRAM(DDRAM)和/或同步DRAM(SDRAM))。
在一种形式中,驱动系统302包括硬件组件,所述硬件组件被实施成用于执行程序指令的处理器308,以用于监测超声外科器械104(图1)的各种可测量特性并生成作为用于在切割和/或凝固操作模式下驱动超声换能器306的输出信号的各种功能。本领域的技术人员应当理解,发生器300和驱动系统302可包括更多或更少的部件,并且为了简明和清楚起见,本文仅描述了简化版本的发生器300和驱动系统302。在各种形式中,如在前所述,硬件部件可作为DSP、PLD、ASIC、电路和/或寄存器实施。在一种形式中,处理器308可被构造成能够存储和执行计算机软件程序指令,以生成用于驱动超声外科器械104(图1)的各种部件(诸如超声换能器306、端部执行器和/或刀340)的输出信号功能。
在一种形式中,在一个或多个软件程序调度程序的控制下,处理器308执行根据所述形式的方法以产生阶跃函数,所述阶跃函数由包括电流(I)、电压(V)和/或针对各种时间间隔或周期(T)的频率(f)的驱动信号的分段波形形成。驱动信号的分段波形可通过形成多个时间间隔的常值函数的分段线性组合生成,所述常值函数通过改变器300驱动信号例如输出电流(I)、电压(V)和/或频率(f)来创建。时间间隔或周期(T)可以是预先确定的(例如,固定的和/或由用户编程的)或者可以是可变的。可变时间间隔能够通过以下方法限定:将驱动信号设定为第一值,以及在监测的特性中检测到变化之前,将驱动信号保持为该值。监测的特性的示例可包括(例如)换能器阻抗、组织阻抗、组织发热、组织横切、组织凝固等等。发生器300所生成的超声驱动信号包括但不限于能够以各种振动模式激发超声换能器306的超声驱动信号,所述振动模式例如为主要纵向模式及其谐波以及弯曲和扭转振动模式。
在一种形式中,可执行模块包括存储在存储器中的一种或多种技术310,当执行这些技术时,使处理器308产生由包括电流(I)、电压(V)和/或针对各种时间间隔或周期(T)的频率(f)的驱动信号的分段波形形成的函数。驱动信号的分段波形能够通过形成两个或更多个时间间隔的常值函数的分段线性组合而产生,所述常值函数通过改变发生器300的输出驱动电流(I)、电压(V)和/或频率(f)来创建。根据所述一个或多个技术310,可针对时间的预定固定时间间隔或周期(T)或时间的可变时间间隔或周期产生驱动信号。在处理器308的控制下,发生器300以特定分辨率上下改变(例如,随时间递增或递减)电流(I)、电压(V)和/或频率(f)持续预定的时间段(T),或者直到检测到预先确定的条件,诸如所监测的特性(例如,换能器阻抗、组织阻抗)的改变。在编程的递增或递减中,所述阶跃可变化。如果需要其他阶跃,则发生器300可适应性地基于测量到的系统特性增加或减少阶跃。
在操作中,用户可利用位于发生器300的控制台的前面板上的输入装置312对发生器300的操作进行编程。输入装置312可包括生成信号314的任何合适的装置,所述信号可被施加到处理器308以控制发生器300的操作。在各种形式中,输入装置312包括远程连接到通用或专用计算机的钮、开关、指轮、键盘、小键盘、触摸屏监测器、指向装置。在其他形式中,输入装置312可包括合适的用户界面。因此,通过输入装置312,用户可设定或编程电流(I)、电压(V)、频率(f)和/或周期(T),以对发生器300的输出函数进行编程。随后处理器308通过将在线信号316发送到输出指示器318来显示选定的功率电平。
在各种形式中,输出指示器318可为外科医生提供视觉、听觉和/或触觉反馈,以指示外科手术的状态,诸如(例如)基于测量到的超声外科器械104的特性(图1)(例如换能器阻抗、组织阻抗)或随后描述的其他测量来确定组织切割和凝固何时完成。以举例(而非限制)的方式,视觉反馈包括任何类型的视觉指示装置,包括白炽光灯或发光二极管(LED)、图形用户界面、显示器、模拟指示器、数字指示器、柱状图显示器、数字字母显示器。以举例(而非限制)的方式,听觉反馈包括任何类型的蜂鸣器、计算机产生的音调、计算机化语音、通过声音/语音平台与计算机相互作用的声音用户界面(VUI)。通过举例而非限制的方式,触觉反馈包括通过接纳柄部组件的器械提供的任何类型的振动反馈。
在一种形式中,处理器308可被构造用于或被编程用于生成数字电流驱动信号320和数字频率信号322。这些驱动信号320,322被施加到直接数字合成器(DDS)电路324,以调节至超声换能器306的输出驱动信号304的振幅和频率(f)。DDS电路324的输出被施加到放大器326,所述放大器的输出被施加到变压器328。变压器328的输出为施加到超声换能器306的输出驱动信号304,所述换能器通过波导连接到刀340。
在一种形式中,发生器300包括一个或多个测量模块或部件,该一个或多个测量模块或部件可被构造成能够监测超声外科器械104(图1)的可测量特性。在所示形式中,可采用处理器308来监测和计算系统特性。如图所示,处理器308通过监测提供至超声换能器306的电流和施加到超声换能器306的电压来测量换能器306的阻抗Z。在一种形式中,采用电流感测电路330来感测施加到超声换能器306的电流,并且采用电压感测电路332来感测施加到超声换能器306的输出电压。这些信号能够通过模拟多路复用器334电路或开关电路结构被施加到模数转换器336(ADC)。模拟多路复用器334将合适的模拟信号沿特定路线发送至模数转换器336,以用于转换。在其他形式中,可采用多个模数转换器336来替代多路复用器334电路用于每一个测量的特性。处理器308接收模数转换器336的数字输出338,并基于电流和电压的测量值计算换能器阻抗Z。处理器308调节输出驱动信号304,使得所述驱动信号可产生期望的功率与负载的曲线关系。根据已编程的技术310,处理器308可响应于换能器阻抗Z以任何合适的增量或减量改变驱动信号320(例如,电流或频率)。
根据图1所示外科系统100的各种形式的操作性细节,可根据采用外科器械针对切割和凝固血管的处理来进一步地描述上述外科系统100的操作,所述外科器械包括输入装置110和参照图6描述的驱动系统302的换能器阻抗测量能力。虽然结合操作细节描述了具体过程,但可理解,该过程只是提供了外科系统100可如何实施本文所述的一般功能的示例。此外,除非另外指明,否则给定的过程不一定按照本文呈现的次序执行。
图7示出了包括组织阻抗模块442的发生器400的驱动系统的一个方面。驱动系统402生成超声电子驱动信号404,以驱动超声换能器406。在一个方面,组织阻抗模块442被构造成能够测量夹持刀440和夹持臂组件444之间的组织的阻抗Zt。组织阻抗模块442包括RF振荡器446、电压感测电路448和电流感测电路450。电压和电流感测电路448,450响应施加到刀440电极上的RF电压Vrf和流过刀440电极、组织和夹持臂组件444的导电部分的RF电流irf。来自电流感测电路430和电压感测电路432的感测电流Irf和的感测电压Vrf经由ADC436经由模拟多路复用器434被转换成数字形式。处理器408接收ADC 436的数字化输出438,并通过计算由电压感测电路448和电流感测电路450测量到的RF电压Vrf与电流Irf的比率来确定组织阻抗Zt。
在一种形式中,处理器408可被构造用于或被编程用于生成数字电流信号420和数字频率信号422。这些信号420,422被施加到直接数字合成器(DDS)电路424,以调节至换能器406的电流输出信号404的振幅和频率(f)。DDS电路424的输出被施加到放大器426,所述放大器的输出被施加到变压器428。变压器428的输出为施加到超声换能器406的信号404,所述换能器通过波导连接到刀440。
在一个方面,能够通过感测组织阻抗Zt来检测肌肉内层和组织的横切。因此,组织阻抗Zt的检测与自动化处理可以是一体式的,所述自动化处理用于在横切组织之前将肌肉内层与外膜外层分离,而不引起通常在共振时引起的显著的发热量。
在一种形式中,施加到刀440电极的RF电压Vrf和流过刀440电极、组织和夹持臂组件444的导电部分的RF电流Irf适用于脉管密封和/或解剖。因此,发生器400的RF功率输出可被选择用于诸如组织阻抗测量的非治疗功能以及诸如血管密封和/或解剖的治疗功能。应当理解,在本公开的上下文中,超声和RF电外科能量可由发生器单独地或同时提供。
在操作中,用户可利用位于发生器400的控制台的前面板上的输入装置412对发生器400的操作进行编程。输入装置412可包括生成信号414的任何合适的装置,所述信号可被施加到处理器408以控制发生器400的操作。在各种形式中,输入装置412包括远程连接到通用或专用计算机的钮、开关、指轮、键盘、小键盘、触摸屏监测器、指向装置。在其他形式中,输入装置412可包括合适的用户界面。因此,通过输入装置412,用户可设定或编程电流(I)、电压(V)、频率(f)和/或周期(T),以对发生器400的函数输出进行编程。随后处理器408通过将在线信号416发送到输出指示器418来显示选定的功率电平。
在各种形式中,由输出指示器418提供反馈。输出指示器418在以下应用中特别有用:其中被端部执行器操纵的组织脱离使用者的视野并且使用者看不见组织中何时发生状态变化。输出指示器418向用户传达组织状态已发生改变。如前所讨论的,输出指示器418可被构造成能够向用户提供各种类型的反馈,包括但不限于视觉、听觉和/或触觉反馈,以提醒用户(例如,外科医生、临床医生)组织已发生组织的状态或状况变化。以举例(而非限制)的方式,如前所论,视觉反馈包括任何类型的视觉指示装置,包括白炽光灯或LED、图形用户界面、显示器、模拟指示器、数字指示器、柱状图显示器、数字字母显示器。以举例(而非限制)的方式,听觉反馈包括任何类型的蜂鸣器、计算机产生的音调、计算机化语音、通过声音/语音平台与计算机相互作用的VUI。通过举例而非限制的方式,触觉反馈包括通过接纳柄部组件的器械提供的任何类型的振动反馈。组织状态的改变可基于如前所述的换能器和组织阻抗测量结果或者基于电压、电流和频率测量结果来确定。
在一种形式中,包括计算机可读指令的各种可执行模块(例如,算法410)可由发生器400的处理器408部分执行。在各种形式中,关于技术所述的操作可被实施成:一个或多个软件部件,例如,程序、子程序、逻辑;一个或多个硬件组件,例如,处理器、DSP、PLD、ASIC、电路、寄存器;和/或软件与硬件的组合。在一种形式中,执行这些技术的可执行指令可存储在存储器中。当被执行时,所述指令使得处理器408确定组织状态的变化并通过输出指示器418向用户提供反馈。根据此类可执行指令,处理器408监测并评估可从发生器400获得的电压、电流和/或频率信号样本,并根据对这些信号样本的评估来确定组织状态是否发生变化。如以下的进一步描述,组织状态的变化可基于超声器械的类型和激发所述器械的功率电平来确定。响应所述反馈,能够通过使用者控制或可自动或半自动地控制超声外科器械的操作模式。
如上所述,单个输出发生器可通过单个端口传送RF能量和超声能量,并且这些信号可分开或同时传送到端部执行器以处理组织。单个输出端口发生器可包括具有多个抽头的单个输出变压器,以根据正在执行的组织处理类型向端部执行器提供功率(RF能量或超声能量)。例如,发生器可通过以下方式传送能量:采用较高的电压和较低的电流以驱动超声换能器,根据需要采用较低的电压和较高的电流以驱动用于密封组织的电极,或者使用单极或双极电外科电极采用凝固波形进行点凝固。来自发生器的输出波形可被操纵、切换或过滤,以向外科器械的端部执行器提供期望的频率。
图8示出了用于将多种能量模态传送到外科器械的发生器500的一个实施例。发电机500类似于结合图1描述的发电机102,并且包括图5至图7所示的发生器200,300,400的功能。为了使公开内容简洁和清楚,在下文中,结合为高级框图表示的发生器500描述各种逻辑流程图。因此,读者被引导至图5至图7中发生器200,300,400的功能块的描述以了解附加细节,这些附加细节对于理解和实践下文结合发生器500描述的逻辑流程图而言可能是必需的。
重新转到图8,发生器500提供射频和超声信号以将能量传送到外科器械。射频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传送多种能量模态(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),并且这些信号可分开或同时被传送到端部执行器以处理组织。发生器500包括联接到波形发生器504的处理器502。处理器502和波形发生器504被构造成能够基于存储在联接到处理器502的存储器中的信息来生成各种信号波形,为了清楚起见而未示出。与波形相关联的数字信息被提供给波形发生器504,该波形发生器包括一个或多个数模(DAC)转换器以将数字输入转换成模拟输出。模拟输出被馈送到放大器1106用于信号调节和放大。放大器506的经调节和放大的输出端联接到功率变压器508。信号通过功率变压器508联接到患者隔离侧的次级侧。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510两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”能够被用来指定可提供多至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,可提供多至“n”个返回路径RETURNn。
第一电压感测电路512联接在被标记为ENERGY1的端子和RETURN路径两端,以测量其间的输出电压。第二电压感测电路524联接到被标记为ENERGY2的端子和RETURN路径的两端,以测量其间的输出电压。如图所示,电流感测电路514与功率变压器508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。第一电压感测电路和第二电压感测电路512,524的输出被提供给相应的隔离变压器516,522,并且电流感测电路514的输出被提供给另一隔离变压器518。功率变压器508(非患者隔离侧)的初级侧上的隔离变压器516,518,522的输出被提供给一个或多个模数转换器526(ADC)。ADC 526的数字化输出被提供给处理器502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502和患者隔离电路之间的输入/输出通信通过接口电路520提供。传感器也可通过接口520与处理器502电连通。
在一个方面,阻抗可由处理器502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512的输出或联接在被标记为ENERGY2/RETURN的端子两端的第二电压感测电路524的输出除以与功率变压器508的次级侧的RETURN支路串联设置的电流感测电路514的输出来确定。第一电压感测电路和第二电压感测电路512,524的输出被提供给单独的隔离变压器516,522,并且电流感测电路514的输出被提供给另一隔离变压器516。来自ADC 526的数字化电压和电流感测测量结果被提供给处理器502用于计算阻抗。例如,第一能量模态ENERGY1可以是超声能量,第二能量模态ENERGY2可以是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。而且,虽然图8所示的实施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512的输出除以电流感测电路514的输出来测量,并且组织阻抗可通过将第二电压感测电路524的输出除以电流感测电路514的输出来测量。
如图8所示,包括至少一个输出端口的发生器500可包括具有单个输出端和具有多个抽头的功率变压器508,以例如根据正在执行的组织处理类型向端部执行器提供一种或多种能量模态(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)的形式的功率。例如,发生器500可通过以下方式传送能量:采用较高的电压和较低的电流以驱动超声换能器,采用较低的电压和较高的电流以驱动RF电极用于密封组织,或者使用单极或双极RF电外科电极采用凝固波形进行点凝固。来自发生器500的输出波形可被操纵、切换或过滤,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500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8所示。在一个示例中,RF双极电极与发生器500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ENERGY2输出端的有源电极(例如,铅笔或其他探头)以及连接至RETURN输出端的合适的返回垫。
在其他方面,结合图1至图3和图5至图8所述的发生器102,200,300,400,500、超声发生器驱动电路114和/或如结合图3所述的电外科/RF驱动电路116可以与结合图1和图2所述的外科器械104,106,108中的任一者整体地形成。因此,结合发生器102,200,300,400,500中的任一者所述的处理器、数字信号处理器、电路、控制器、逻辑装置、ADC、DAC、放大器、转换器、变压器、信号调节器、数据接口电路、电流和电压感测电路、直接数字合成电路、多路复用器(模拟或数字)、波形发生器、RF发生器、存储器等中的任何一个可位于外科器械104,106,108内,或者可从外科器械104,106,108远程定位并且经由有线和/或无线电连接件联接到这些外科器械。
在其他方面,结合图1至图3和图5至图8所述的发生器102,200,300,400,500、超声发生器驱动电路114和/或如结合图3所述的电外科/RF驱动电路116可以与结合图1和图2所述的外科器械104,106,108中的任一者整体地形成。因此,结合发生器102,200,300,400,500中的任一者所述的处理器、数字信号处理器、电路、控制器、逻辑装置、ADC、DAC、放大器、转换器、变压器、信号调节器、数据接口电路、电流和电压感测电路、直接数字合成电路、多路复用器(模拟或数字)、波形发生器、RF发生器、存储器等中的任何一个可位于外科器械104,106,108内,或者可从外科器械104,106,108远程定位并且经由有线和/或无线电连接件联接到这些外科器械。
在图9至图13中示出了代表用于从发生器传送的能量的波形的实施例。图9示出了示例曲线图600,其示出了出于比较目的叠加在相同时间和电压标度上的代表RF输出信号602和超声输出信号604的第一单个波形和第二单个波形。这些输出信号602,604被提供在图8所示的发生器500的ENERGY输出端处。时间(t)沿水平轴显示,并且电压(V)沿竖直轴显示。RF输出信号602的频率为约330kHz RF,峰间电压为±1V。超声输出信号604的频率为约55kHz,峰间电压为±1V。应当理解,沿水平轴的时间(t)标度和沿垂直轴的电压(V)标度出于比较目的而被归一化,并且可以是不同的实际具体实施,或者代表诸如电流的其他电学参数。
图10示出了图9所示的两个输出信号602,604之和的示例曲线图610。时间(t)沿水平轴显示,并且电压(V)沿竖直轴显示。图9所示的RF输出信号602和超声输出信号604之和产生具有2V峰间电压的组合输出信号612,该组合输出信号是图9所示的原始RF信号和超声信号的幅值(1V峰间电压)的两倍。原始幅值的两倍幅值可能会引起发生器的输出部分出现问题,诸如失真、饱和、输出的限幅或输出元件上的应力。因此,具有多个处理部件的单个组合输出信号612的管理是图8所示的发生器500的重要方面。有多种方法可实现这种管理。在一种形式中,两个RF输出信号或超声输出信号602,604中的一者可取决于另一输出信号的峰值。
例如,图11示出了示例曲线图620,该曲线图示出了代表图9所示的输出信号602,604的因变和的组合输出信号622。时间(t)沿水平轴显示,并且电压(V)沿竖直轴显示。如图11所示,图9的RF输出信号602分量取决于图9的超声输出信号604的峰值,使得当预计超声峰值时,该相关之和的组合输出信号622的RF输出信号分量的幅值减小。如图11中的示例曲线图620所示,峰值已从2降至1.5。在另一种形式中,输出信号中的一者是另一输出信号的函数。
例如,图11示出了示例曲线图630,该曲线图示出了代表图9所示的输出信号602,604的因变和的输出信号632。时间(t)沿水平轴显示,并且电压(V)沿竖直轴显示。如图12所示,RF输出信号是超声输出信号的函数。这对输出的幅值提供了严格的限制。如图12所示,在RF输出信号具有失真但不以一种方式影响RF输出信号的凝聚性能时,超声输出信号可提取为正弦波。
可使用各种其他技术来压缩和/或限制输出信号的波形。应当指出的是,只要RF输出信号602具有用于安全患者水平的低频分量,超声输出信号604(图9)的完整性可比RF输出信号602(图9)的完整性更重要,以避免神经肌肉刺激。在另一形式中,为了管理波形的峰值,可连续改变RF波形的频率。由于更复杂的RF波形(诸如图13中的曲线图640所示的凝聚型波形644)与系统一起实现,波形控制很重要。同样,时间(t)沿水平轴显示,并且电压(V)沿竖直轴显示。
图14至图42(图26至图54)示出了用于测量组织参数以便于执行本文所述的各种适应性组织识别和治疗技术的传感器、电路和技术的各种配置。图14示出了包括位于夹持臂702上的RF数据传感器706,708a,708b的端部执行器700的一个方面。端部执行器700包括夹持臂702和超声刀704。夹持臂702被示出为夹持位于夹持臂702和超声刀704之间的组织710。第一传感器706位于夹持臂702的中心部分。第二和第三传感器708a,708b位于夹持臂702的侧向部分上。传感器706,708a,708b安装在柔性电路712(更具体地在图15中示出,并且分段柔性电路800,900更具体地在图17和18中示出)上或与其整体地形成,该柔性电路被构造成能够固定安装到夹持臂702。
端部执行器700是用于图1和图2所示的多功能外科器械108的示例端部执行器。传感器706,708a,708b电连接到能量源,例如图8所示的发生器500。传感器706,708a,708b由发生器内的合适的源供电,并且由传感器706,708a,708b所生成的信号被提供到发生器500的模拟和/或数字处理电路。
在一方面,第一传感器706是测量通过夹持臂702施加到组织710的法向力F3的力传感器。第二和第三传感器708a,708b包括将RF能量施加到组织710,测量组织阻抗、下压力F1、侧向力F2以及温度等参数的一个或多个元件。电极709a,709b电联接到发生器并将RF能量施加到组织710。在一方面,第一传感器706以及第二和第三传感器708a,708b是测量力或每单位面积的力的应变仪。应当理解,下压力F1、侧向力F2以及法向力F3的测量结果可通过确定力传感器706,708a,708b作用其上的表面积而容易地转换成压力。另外,如本文具体描述的那样,柔性电路712可包括嵌入在柔性电路712的一个或多个层中的温度传感器。所述一个或多个温度传感器可对称地或非对称地布置,并向发生器的控制电路提供组织710的温度反馈。
图15示出了图14所示的柔性电路712的一个方面,其中传感器706,708a,708b可安装到该柔性电路或与其整体地形成。柔性电路712被构造成能够固定地附接至夹持臂702。特别地如图15所示,非对称温度传感器714a,714b被安装到柔性电路712以能够测量组织710的温度(图14)。
图16是图15所示的柔性电路712的剖视图。柔性电路712包括多个层并且被固定地附接至夹持臂702。柔性电路712的顶层是电极709a,该电极电联接到诸如发生器102,200,300,400,500(图1至图3和图4至图8)的能量源以将RF能量施加到组织710(图14)。在电极709a层下方提供电绝缘层718以将传感器714a,706,708a与电极709a电隔离。温度传感器714a设置在电绝缘层718下方。第一力(压力)传感器706位于包括温度传感器714a的层下方并且在压缩层720上方。第二力(压力)传感器708a位于压缩层720下方并且在夹持臂702框架上方。
图17示出了被构造成能够固定地附接至端部执行器的夹持臂804的分段柔性电路800的一个方面。分段柔性电路800包括远侧段802a和包括提供局部组织控制的可单独寻址的传感器的侧向段802b,802c,例如,如本文结合图14至图16所述。片段802a,802b,802c可单独寻址以处理组织并且可基于位于每个片段802a,802b,802c内的各个传感器测量组织参数。分段柔性电路800的片段802a,802b,802c被安装到夹持臂804并且通过导电元件806电联接到诸如发生器102,200,300,400,500(图1至图3和图4至图8)的能量源。霍尔效应传感器808或任何合适的磁性传感器位于夹持臂804的远侧端部。霍尔效应传感器808结合磁体操作,以提供对由夹持臂804限定的口径的测量,该口径可被称为组织间隙,如图19中特别示出的那样。
图18示出了被构造成能够安装到端部执行器的夹持臂904的分段柔性电路900的一个方面。分段柔性电路1900包括远侧段902a和包括用于组织控制的可单独寻址的传感器的侧向段902b,902c,例如,如本文结合图14至图17所述。片段902a,902b,902c可单独寻址以处理组织并且可读取位于每个片段902a,902b,902c中的各个传感器。分段柔性电路900的片段902a,902b,902c被安装到夹持臂904并且通过导电元件906电联接到诸如发生器102,200,300,400,500(图1至图3和图4至图8)的能量源。霍尔效应传感器908或其他合适的磁性传感器设置在夹持臂904的远侧端部。霍尔效应传感器908结合磁体操作,以提供对由端部执行器的夹持臂904限定的口径或组织间隙的测量,如图19中特别示出的那样。另外,多个侧向非对称温度传感器910a,910b安装在分段式柔性电路900上或与其整体地形成,以向发生器中的控制电路提供组织温度反馈。
图19示出了被构造成能够测量组织间隙GT的端部执行器1000的一个方面。端部执行器1000包括钳口构件1002和夹持臂904。图18中所描述的柔性电路900被安装到夹持臂904。柔性电路900包括霍尔效应传感器908,该霍尔效应传感器结合安装到钳口构件1002的磁体1004操作以测量组织间隙GT。该技术可用于测量限定于夹持臂904和钳口构件1002之间的口径。钳口构件1002可以是超声刀。
图20示出了左右分段柔性电路1100的一个方面。左右分段柔性电路1100包括位于左右分段柔性电路1100左侧上的多个片段L1至L5和位于左右分段柔性电路1100右侧上的多个片段R1至R5。每个片段L1至L5和R1至R5包括在每个片段L1至L5和R1至R5内局部感测组织参数的温度传感器和力传感器。左右分段柔性电路1100被构造成能够基于在每个片段L1至L5和R1至R5内局部感测到的组织参数影响RF处理能量。
图21示出了包括如图20所示的分段柔性电路1100的端部执行器1200的一个方面。端部执行器1200包括夹持臂1202和超声刀1204。分段柔性电路1100被安装到夹持臂1202。设置在片段1至5内的每个传感器被构造成能够检测定位在夹持臂1202和超声刀1204之间的组织的存在并且表示组织区域1至5。在图21所示的构型中,端部执行器1200被示出为处于准备好接收或抓持夹持臂1202和超声刀1204之间的组织的打开位置。
图22示出了图21所示的端部执行器1200,其中夹持臂1202将组织1206夹持在夹持臂1202和超声刀1204之间。如图22所示,组织1206被定位在片段1至3之间并且代表组织区域1至3。因此,组织1206由片段1至3中的传感器检测,并且通过片段4至5在节段1208中检测组织的不存在(空)。与分别位于某些片段1至3和4至5内的组织1206的存在和不存在有关的信息被传送到发生器(诸如发生器102,200,300,400,500,图1至图3和图4至图8)的控制电路。发生器500被构造成能够仅激励检测到组织1206的片段1至3,并且不激励没有检测到组织的片段4至5。应当理解,片段1至5可包括测量某些片段1至5内的组织的组织参数的任何合适的温度、力/压力和/或霍尔效应磁性传感器以及将RF能量传送到位于某些片段1至5中的组织的电极。
图23示出了基于局部感测的组织参数由端部执行器的右侧和左侧施加的能量的曲线图1300。如本文所讨论的,端部执行器的夹持臂可沿着夹持臂的右侧和左侧包括温度传感器、力/压力传感器、霍尔效应器传感器等,例如在图14至图22中。因此,RF能量可选择性地施加到定位在夹钳和超声刀之间的组织。顶部曲线图1302描绘了基于局部感测的组织参数施加到夹持臂的右侧片段的功率PR与时间(t)的关系。因此,诸如发生器102,200,300,400,500(图1至图3和图4至图8)的发生器被构造成能够测量感测到的组织参数并将功率PR施加到夹持臂的右侧片段。发生器500通过右侧片段将初始功率电平P1传送到组织然后基于一个或多个片段中的组织参数(例如,温度、力/压力、厚度)的局部感测将功率电平降低到P2。底部曲线图1304描绘了基于局部感测的组织参数施加到夹持臂的左侧片段的功率PL与时间(t)的关系。发生器500通过左侧片段将初始功率电平P1传送到组织然后基于组织参数(例如,温度、力/压力、厚度)的局部感测将功率电平增加到P3。如底部曲线图1304所描绘的,发生器被构造成能够基于组织参数(例如,温度、力/压力、厚度)的感测重新调整传送的能量P3。
图24示出了描绘根据诸如连续性、温度、压力等的辅助组织参数的测量所进行的阈值调节的一个方面的曲线图1400。曲线图1400的水平轴是时间(t),竖直轴是组织阻抗(Z)。曲线1412表示由于不同能量模态被施加到组织,组织阻抗(Z)随时间(t)的变化。同时参考图20至图22,当在全部五个片段1至5(组织区域1至5)中都检测到组织时应用原始阈值1402,并且当在组织片段1至3(组织区域1至3)中检测到组织时应用所调整的阈值1404。因此,一旦组织位于特定的片段(区域)中,发生器中的控制电路相应地调整阈值。
如图24所示,曲线1412包括三个不同的部分1406,1408,1410。曲线1412的第一部分1406表示当RF能量被施加到组织区域1至3中的组织直到组织阻抗下降到所调整的阈值1404以下的时间。在可指示组织密封完成的那个点1414处,施加到组织区域1至3的能量模态从RF能量改变为超声能量。然后在第二和第三部分1408,1410中施加超声能量,并且阻抗呈指数级增长直到组织被切断或切割。
图25是包括嵌入其中的RF电极和数据传感器的柔性电路1500的一个方面的剖视图。柔性电路1500可安装到由诸如金属的导电材料制成的RF夹持臂1502的右侧部分或左侧部分。在RF夹持臂1502下方,下压力/压力传感器1506a,1506b嵌入层压层1504下方。侧向力/压力传感器1508位于下压力/压力传感器1506a,1506b层下方,并且温度传感器1510位于侧向力/压力传感器1508下方。电联接到发生器并且被构造成能够将RF能量施加到组织1514的电极1512位于温度传感器1510下方。
图26是被构造成能够感测施加到位于夹持臂与超声刀之间的组织的力或压力的端部执行器1600的一个方面的剖视图。端部执行器1600包括夹钳1602和固定安装到夹持臂1602的柔性电路1604。夹持臂1602将力F1和F2施加到可变密度和厚度的组织1606,所述力可由位于柔性电路1604的不同层中的第一和第二力/压力传感器1608,1610测量。压缩层1612被夹在第一和第二力/压力传感器1608,1610之间。电极1614位于柔性电路1604的接触组织的外部。如本文所述,柔性电路1604的其他层可包括附加的传感器,诸如温度传感器、厚度传感器等。
图27至图29示出了信号层的柔性电路、传感器布线和RF能量驱动电路的各种示意图。图27是柔性电路1700的信号层的一个方面的示意图。柔性电路1700包括多个层(例如,~4至~6)。一层将为集成电路提供电源,另一层则提供接地。两个附加的层将分别运载RF功率RF1和RF2。模拟多路复用器开关1702具有八个可通过I2C总线控制的双向转换开关。SCL/SDA上游对扇出到八个下游对或通道。任何单独的SCn/SDn通道或通道的组合都可通过可编程控制寄存器的内容来选择、确定。上游对SCL/SDA连接到发生器中的控制电路。有六个下游传感器,夹持臂两侧各有三个。第一侧1704a包括第一热电偶1706a、第一压力传感器1708a和第一霍尔效应传感器1710a。第二侧1704b包括第二热电偶1706b、第二压力传感器1708b和第二霍尔效应传感器1710b。图28是用于图27所示的柔性电路1700的传感器布线的示意图1750。
图29是RF能量驱动电路1800的一个方面的示意图。RF能量驱动电路1800包括结合图27所述的模拟多路复用器1702。模拟多路复用器多路复用来自上游通道SCL/SDA的各种信号。电流传感器1802与电源电路的返回引脚或接地引脚串联联接,以测量由电源提供的电流。FET温度传感器1804提供环境温度。如果主程序忽略周期性地服务,则脉宽调制(PWM)看门狗定时器1808自动生成系统复位。当RF能量驱动电路1800由于软件或硬件故障而停摆时,其提供了RF能量驱动电路的自动复位。
驱动电路1806提供左右RF能量输出端。从发生器的控制电路将数字信号提供到模拟多路复用器1702的SCL/SDA输入端。数模转换器(DAC)将数字输入转换成模拟输出以驱动联接到振荡器1814的脉宽调制(PWM)电路1812。PWM电路1812向第一晶体管输出级1818a提供第一栅极驱动信号1816a以驱动第一RF(左)能量输出端。PWM电路1812还向第二晶体管输出级1818ab提供第二栅极驱动信号1816b以驱动第二RF(右)能量输出端。
结合图27至图29所述的电路1700,1750,1800电联接到图5至图7所示的发生器200,300,400,500。例如,电路1700,1750,1800可通过信号调节电路244联接到发生器200,并且可通过接口电路520联接到发生器500。
图30是在预设时间测量组织间隙的图形表示1900。第一曲线图1902表示组织阻抗Z与时间(t)的关系,其中水平轴表示时间(t)并且竖直轴表示组织阻抗Z。第二曲线图1904表示组织间隙Δgap的变化与时间(t)的关系,其中水平轴表示时间(t)并且竖直轴表示组织间隙Δgap的变化。第三曲线图1906表示力F与时间(t)的关系,其中水平轴表示时间(t)并且竖直轴表示力F。利用施加到组织的恒定力F和阻抗Z询问以限定等待周期、能量模态(例如,RF和超声波)和马达控制参数,一次的位移提供了速度。参考三个曲线图1902,1904,1906,在第一时间段1908内施加阻抗感测能量以确定组织类型,诸如薄肠系膜组织(实线)、中等厚度的脉管组织(虚线)或厚子宫/肠组织(点划线)。
如第三曲线图1906所示,夹持臂最初施加从零呈指数级增加直到其达到恒定力1924为止的力。选择预设时间t1使得其在夹持臂力达到恒定力1924之后的一段时间发生。如第一和第二曲线图1902,1904所示,从夹持力被施加到肠系膜组织到达到预设时间t1为止,组织间隙Δgap的变化曲线1912呈指数级减小并且组织阻抗曲线1918在达到预设时间t1之前也减小。从预设时间t1开始,在将处理能量在tE1处施加到肠系膜组织之前,施加短暂延迟1928。
如第一曲线图和第二曲线图1902,1904所示,从夹持力被施加到脉管组织的时间起一直到达到预设时间t1为止,组织间隙Δgap的变化曲线1916也呈指数级减小并且组织阻抗曲线1920在达到预设时间t1之前也减小。从预设时间t1开始,在将处理能量在tE2处施加到脉管组织之前,施加中等延迟1930。
如第一曲线图和第二曲线图1902,1904所示,从夹持力被施加到子宫/肠组织的时间起一直到达到预设时间t1为止,组织间隙Δgap的变化曲线1914呈指数级下降并且组织阻抗曲线1914在达到预设时间t1之前也下降。从预设时间t1开始,在将处理能量在tE1处施加到肠系膜组织之前,施加短暂延迟1928。
图31是用于针对薄的、中等的和厚的组织类型预设的力2008与时间关系的时间图2000。水平轴表示时间(t)并且竖直轴表示由夹持臂施加到组织的力(F)。曲线图2000描绘了三条曲线,一条用于以实线示出的薄组织2002,一条用于以点划线示出的中等厚度组织2004以及以虚线示出的厚组织2006。曲线图2000描绘了将预设力下的测量时间作为组织间隙的替代形式以控制延迟能量模式和其他控制参数。因此,用于厚组织2006的预设力2008的时间为t1a,用于中等厚度组织2004的预设力2008的时间是t1b,并且用于薄组织2002的预设力2008的时间是t1c。
一旦力达到预设力2008,则能量被施加到组织。对于薄组织2002,预设时间t1c>0.5秒,然后在通电时间段te施加RF能量约1至3秒。对于厚组织2006,预设时间t1a<0.5秒,然后在通电时间段te施加RF能量约5至9秒。对于中等厚度的组织2004,预设时间t1b为约0.5秒,然后在通电时间段te施加RF能量约3至5秒。
图32是三条曲线2102,2104,2106的曲线图2100的图形描绘,其中第一曲线2102代表功率(P)、电压(VRF)和电流(IRF)与组织阻抗(Z)的关系,第二曲线2104和第三曲线2106代表组织阻抗(Z)与时间(t)的关系。第一曲线2102示出了用于厚组织阻抗范围2110和薄组织阻抗范围2112的功率(P)的应用。当组织阻抗Z增加时,电流IRF减小并且电压VRF增加。功率曲线P增加,直到其达到与电流IRF和电压VRF的交点2114重合的最大功率输出2108为止。
第二曲线2104表示所测得的组织阻抗Z与时间(t)的关系。组织阻抗阈值极限2120是用于在RF和超声能量模态之间切换的跨越极限。例如,如图32所示,在组织阻抗高于组织阻抗阈值极限2120时施加RF能量,并且在组织阻抗低于组织阻抗阈值极限2120时施加超声能量2124。因此,重新参考第二曲线2104,薄组织曲线2116的组织阻抗保持高于组织阻抗阈值极限2120,从而仅将RF能量模态施加到组织。在另一方面,在阻抗高于组织阻抗阈值极限2120时,将RF能量模态施加到厚组织,并且当阻抗低于组织阻抗阈值极限2120时,将超声能量施加到组织。因此,当组织阻抗下降到低于组织阻抗阈值极限2120时,能量模态从RF切换到超声并且当组织阻抗上升到高于组织阻抗阈值极限2120时,能量模态从超声切换到RF。
图33是端部执行器2200的一个方面的平面图。端部执行器2200包括夹持臂2202和轴2204。夹持臂2202围绕枢转点2206枢转并限定枢转角度。图34是图33所示的端部执行器2200的侧视图,其具有局部剖面图以暴露出夹持臂2202和超声刀2208的底层结构。电极2210固定安装到夹持臂2202。电极2210电联接到发生器并且被构造成能够将RF能量施加到位于夹持臂2202和超声刀2208之间的组织。图35是图33、图34所示的端部执行器的局部剖视图,以分别暴露出超声刀和左右电极2210a,2210b。
图36是在图33中所示的端部执行器2200的截面36--36截取的剖视图。端部执行器2200包括声学地联接到被发生器电驱动的超声换能器的超声刀2208。夹持臂2202包括位于右侧上的电极2210a和位于左侧上的电极2210b(从操作者的角度来看)。右侧电极2210a限定第一宽度W1并限定介于电极2210a和超声刀2208之间的第一间隙G1。左侧电极2210b限定第二宽度W2并限定介于电极2210b和超声刀2208之间的第二间隙G2。在一方面,第一宽度W1小于第二宽度W2并且第一间隙G1小于第二间隙G2。同时参考图35,软质聚合物垫2212位于超声刀2208与夹持臂2202之间。高密度聚合物垫2214与软聚合物垫2212相邻定位,以防止超声刀2208使电极2210a,2210b短路。在一方面,软聚合物垫2212,2214可由例如以商品名特氟隆(聚四氟乙烯聚合物和共聚物)已知的聚合物制成。
图37是在图33中所示的端部执行器2200的截面37--37截取的剖视图。在该平面上,端部执行器2200的截面37-37更薄并且具有比截面36--36更大的曲率。右侧电极2210a限定第三宽度W3并限定介于电极2210a和超声刀2208之间的第三间隙G3。左侧电极2210b限定第四宽度W4并限定介于电极2210b和超声刀2208之间的第四间隙G4。在一方面,第三宽度W3小于第四宽度W4并且第三间隙G3小于第四间隙G4。
图38是在图33中所示的端部执行器2200的截面36--36截取的剖视图,不同之处在于超声刀2208’具有不同的几何构造。端部执行器2200'包括声学地联接到被发生器电驱动的超声换能器的超声刀2208’。夹持臂2202'包括位于右侧上的电极2210a'和位于左侧上的电极2210b'(从操作者的角度来看)。右侧电极2210a'限定第一宽度W1并限定介于电极2210a'和超声刀2208'之间的第一间隙G1。左侧电极2210b'限定第二宽度W2并限定介于电极2210b'和超声刀2208'之间的第二间隙G2。在一方面,第一宽度W1小于第二宽度W2并且第一间隙G1小于第二间隙G2。高密度聚合物垫2214'与软聚合物垫2212'相邻定位,以防止超声刀2208'使电极2210a',2210b'短路。在一方面,软聚合物垫2212',2214'可由例如以商品名特氟隆(聚四氟乙烯聚合物和共聚物)已知的聚合物制成。
图39是在图33中所示的端部执行器2200的截面37--37截取的剖视图,不同之处在于超声刀2208’具有不同的几何构造。在该平面上,端部执行器2200'的截面37--37更薄并且具有比截面36--36处的端部执行器2200'更大的曲率。右侧电极2210a'限定第三宽度W3并限定介于电极2210a'和超声刀2208'之间的第三间隙G3。左侧电极2210b'限定第四宽度W4并限定介于电极2210b'和超声刀2208'之间的第四间隙G4。在一方面,第三宽度W3小于第四宽度W4并且第三间隙G3小于第四间隙G4。
图40是在图33中所示的端部执行器2200的截面36--36截取的剖视图,不同之处在于超声刀2208’具有不同的几何构造。端部执行器2200”包括声学地联接到被发生器电驱动的超声换能器的超声刀2208”。夹持臂2202”包括位于右侧上的电极2210a”和位于左侧上的电极2210b”(从操作者的角度来看)。右侧电极2210a”限定第一宽度W1并限定介于电极2210a”和超声刀2208”之间的第一间隙G1。左侧电极2210b”限定第二宽度W2并限定介于电极2210b”和超声刀2208”之间的第二间隙G2。在一方面,第一宽度W1小于第二宽度W2并且第一间隙G1小于第二间隙G2。高密度聚合物垫2214”与软聚合物垫2212”相邻定位,以防止超声刀2208”使电极2210a”,2210b”短路。在一方面,聚合物垫2212”,2214”可由例如以商品名特氟隆(聚四氟乙烯聚合物和共聚物)已知的聚合物制成。
图41是在图33中所示的端部执行器2200的截面37--37截取的剖视图,不同之处在于超声刀2208’具有不同的几何构造。在该平面上,端部执行器2200”的截面37--37更薄并且具有比截面36--36处的端部执行器2200”更大的曲率。右侧电极2210a”限定第三宽度W3并限定介于电极2210a”和超声刀2208”之间的第三间隙G3。左侧电极2210b”限定第四宽度W4并限定介于电极2210b”和超声刀2208”之间的第四间隙G4。在一方面,第三宽度W3小于第四宽度W4并且第三间隙G3小于第四间隙G4。
本文描述的外科器械还可以包括这样的特征:其允许由发生器传送的能量基于由外科器械的端部执行器所处理的组织类型和组织的各种特性而动态地改变。在一个方面,一种用于控制从发生器(例如发生器102,200,300,400,500(图1至图3和图4至图8))输出的功率传送到外科器械的端部执行器的技术可包括代表组织类型的输入,以允许来自发生器的能量分布曲线在规程期间基于受外科器械的端部执行器影响的组织类型而动态地改变。
如本文所公开的,可以提供基于组织类型来控制发生器的技术。可使用各种技术来选择功率分布曲线,以允许正从发生器传送的能量基于正由外科器械处理的组织类型而动态地改变。
图42A示出了包括夹持臂2302和超声刀2304的端部执行器2300,其中夹持臂2302包括电极2306。端部执行器2300可用于图1至图3提及的外科器械104,106,108之一。除了端部执行器122,124,125之外,外科器械104,106,108分别包括手持件105,107,109和轴126,127,129。端部执行器122,124,125可用于压缩、切割和/或密封组织。参见图42A,类似于图1至图3所示的端部执行器122,124,125的端部执行器2300在压缩、切割或缝合之前可由医生定位在组织2308周围。如图42A所示,在准备使用端部执行器2300时,不可对组织施加压缩。如图42A所示,组织2308在夹持臂2302和超声刀2304之间未处于压缩状态。
现在参考图42B,通过将触发器接合在外科器械的柄部上,医生可以使用端部执行器2300来压缩组织2308。在一方面,组织2308可被压缩到其最大阈值,如图42B所示。如图42A所示,组织2308在夹持臂2302和超声刀2304之间处于最大压缩状态。
参见图43A,可通过端部执行器2300将各种力施加到组织2308。例如,当组织2308被压缩在端部执行器2300的夹持臂2302和超声刀2304之间时,可通过夹持臂和超声刀施加垂直力F1和F2。现在参考图43B,当组织被端部执行器2300压缩时,还可向组织2308施加各种对角线力和/或侧向力。例如,可施加力F3。为了操作诸如外科器械104,106,108的医疗装置,期望感测或计算由端部执行器施加到组织的各种形式的压缩。例如,已知垂直或侧向压缩可允许端部执行器更精确或准确地实施钉操作或者可通知外科器械的操作者,从而能够更正确或安全地使用外科器械。
在一种形式中,可以使用应变仪来测量由图42A-B和图43A-B中所示端部执行器施加到组织2308的力。应变仪可以联接到端部执行器2300来测量由端部执行器2300处理的组织2308上的力。现在同时参考图44,在图44所示的方面中,用于测量施加到组织2308的力的系统2400包括应变仪传感器2402(诸如微应变仪)被构造成能够测量端部执行器2300的一个或多个参数,例如,在夹持操作期间施加到端部执行器的夹持臂(诸如图43A至图43B的夹持臂2302)上的应变的幅值,该幅值可表示组织压缩。将测得的应变转换成数字信号并将其提供到微控制器2408的处理器2410。载荷传感器2404可测量力以操作超声刀2304切割捕集在端部执行器2300的夹持臂2302与超声刀2304之间的组织2308。可采用磁场传感器2406来测量捕集的组织2308的厚度。磁场传感器2406的测量结果也可被转换成数字信号并提供给处理器2410。
除上述以外,反馈指示器2414被构造成能够与微控制器2408进行通信。在一方面,反馈指示器2414可设置在外科器械的柄部中,诸如在图1至图3中示出的那些外科器械。另选地,例如,反馈指示器2414可设置在外科器械的轴组件中。在任何情况下,微控制器2408可采用反馈指示器2414向外科器械的操作者提供关于手动输入的适当性的反馈,例如,用于促使端部执行器夹持组织的击发触发器的所选择的位置。为此,微控制器2408可评估夹持臂2302和/或击发触发器的所选择的位置。微控制器2408可使用分别由传感器2402,2404,2406测量的组织2308压缩、组织2308的厚度和/或闭合端部执行器2300所需的力的测量结果来表征击发触发器的所选择的位置和/或端部执行器的速度的对应值。在一个示例中,存储器2412可存储可由微控制器2408在评估中所采用的技术、公式和/或查找表。
可以根据以下描述的技术和过程,单独或以组合方式使用本文所述发生器102,200,300,400,500(图1-3和图4-8)、外科器械104,106,108(图1-3)和端部执行器122,124,125,700,800,900,1000,1100,1200,2200,2200’,2200”,2300(图1-3、图14-22、图33-43B)来执行外科规程。然而,为了简洁和清楚,将参考多功能外科器械108和发生器500来描述外科规程。多功能外科器械108包括端部执行器125,该端部执行器包括夹持臂145和超声刀149。端部执行器125可被构造成具有端部执行器122,124,125,700,800,900,1000,1100,1200,2200,2200',2200”,2300中的任何一个的任何结构或功能特征以如上所述的提供电极以将RF能量施加到组织、温度传感器、力/压力传感器以及间隙测量传感器。
具有实时组织系统识别和最优控制的电外科装置
在一个方面,本公开提供了具有实时组织系统识别和最佳控制技术的电外科装置,其中该最佳控制技术用于控制来自发生器诸如发生器102,200,300,400,500(图1至图3以及图4至图8)或外科器械诸如外科器械108(图1至图3)的功率输出。传送到外科器械的端部执行器的功率可以包括这样的输入:其表示实时组织系统识别的反馈,以允许来自发生器的能量分布曲线基于该反馈而在RF能量和超声能量之间动态地改变,以提供最优控制。为了使公开内容简洁和清楚,将参照图2中联接到图8的发生器500的外科器械108来描述具有实时组织系统识别和用于控制来自发生器的功率输出的最佳控制技术的电外科装置,但是应当理解,在不脱离本公开的范围的情况下,可以容易地替换本文所述的器械、发生器和端部执行器的其他构型。
为了确定正由外科器械的端部执行器所处理的组织的阻抗,必须计算组织阻抗。然后可将所计算的组织阻抗与阈值进行比较,这将在下文更详细地讨论。所计算的组织阻抗可以用于控制正从发生器传送到外科器械的能量,以在组织阻抗到达阈值水平时允许能量在RF和超声能量之间进行切换。在一种形式中,通过将电压测量值除以电流测量值来描述组织阻抗。更一般地说,阻抗是电压矢量与电流矢量之比,会得到这样的复数:其中实数部分R和虚数部分X既取决于组织性质又取决于所施加的刺激的频率和频谱。也可按大小、|Z|和相的形式来表达该数。大多数组织阻抗的计算都忽略了电压和电流之间的相位差的较小影响,并且假定阻抗矢量的大小|Z|基本上等于阻抗R的实数部分。出于描述目的,术语R和Z指示组织阻抗将可互换使用,尽管应该注意到,组织阻抗的感测意味着阻抗矢量是该矢量的量值、相位、实数部分和虚数部分的一般形式及其任意组合,用于如本公开所暗示地确定组织性质、控制能量传送等。
例如,当使用可在RF和超声能量之间自动转变的器械时,可使用端部执行器将RF能量施加到组织,以将组织的组织阻抗驱动到特定水平,诸如终止阻抗。终止阻抗是组织的这样一种组织阻抗水平:其基本上确保RF能量已实现了组织的充分凝固,在这种情况下,用于从RF能量传送转变为超声能量传送。本文定义的终端阻抗可意指已经发生了充分的凝固,并且是时候施加切割能量,或者组织准备好接收超声能量以继续凝固和/或切割。在其他方面,RF能量和超声能量可以在转换期间混合存在,而不是以“一个接一个”型的方式存在。
图45示出了阻抗(|Z|)对时间(t)曲线2500的示例曲线图,其示出了使用RF能量实现适当组织密封的终端阻抗。曲线2500沿横轴提供了以秒为单位的时间,并且沿纵轴提供了以欧姆为单位的阻抗。分三个节段2502、2504和2506来描述阻抗对时间的曲线2500。第一节段2502表示从能量刚被施加到组织的时间2508到组织阻抗下降到如第二节段2504所示的最小值的时间2510的组织的初始阻抗。曲线2500的第一节段2502针对初始阻抗|Z|而下降,直到该阻抗稳定到曲线2500第二节段2504中的最小阻抗为止。在将能量传送到端部执行器并且施加到组织达一段时间(例如,如图所示的4.5秒)之后,组织的含水量蒸发,导致组织干燥并且导致组织的阻抗在曲线的第三节段2506中上升直至达到终止阻抗|ZT|,在该时间点To处,传送到端部执行器的能量被切断。曲线2500中第三节段2506的那部分(以虚线示出)表示如果继续施加能量而不是在终止阻抗|ZT|点处切断能量将导致的组织阻抗|Z|的增加。
一旦达到终止阻抗|ZT|,发生器就可以从传送RF能量切换到传送超声能量。终止阻抗|ZT|可以是基于器械的电极和压缩特性的固定值,或者其可以是取决于在抓持和凝固循环期间测量的因素(诸如,抓持的组织量、初始阻抗和最小阻抗)的变量。它也可以是取决于各种阻抗斜率、凝血循环中各个点处的能量传送(诸如最小阻抗)和/或拐点及其组合的变量。
作为时间函数的组织阻抗是时间的连续可微函数。通过系统识别技术和系统参数优化可以看出,存在可以模拟功率输入与组织的关系的模型。该模型的形式如下:
在等式1中,Z是贯穿组织而测量的(从已知电流和电压估算的)阻抗,Z和Z是组织阻抗的一阶导数和二阶导数。k、b1、b2、c1和c2是要估计的参数。W是应用于组织的功(以焦耳计)。使用下坡单纯形和基于全局的优化技术的组合,例如演化过程、粒子群优化和模拟退火。参数可以准实时地得到估算,这短于用户可觉察的时间段。
图46示出了组织阻抗与组织阻抗时间的关系的曲线2602,2604,其中使用组织模型2602和实验数据2604的下坡单纯形技术将40W的RF功率传送到组织。如图46所示,曲线2602,2604类似于图45所示的曲线2500。
如图46的曲线所示,在0秒到8.8秒的时间段内,可将恒定功率施加到组织,由于在密封过程中将功率施加到组织时,作为时间的函数的组织阻抗具有特征性浴缸形状,因此曲线2602,2604具有可被称为“浴缸”的独特形状。一旦在组织“浴缸”期间发生了系统识别以估计上述公式1的k、b1、b2、c1和c2,就可针对与外科器械108的端部执行器125相互作用的组织来配置后“浴缸”阻抗控制技术。
一种后“浴缸”阻抗控制技术利用参数估计来确定组织特性。在一个方面,在“浴缸”阶段期间估计的参数可涉及某些组织特性,例如组织类型、组织量和组织状态。预定的控制器可以从与根据查表而估计的参数最佳匹配的一系列控制器中选择。
另一种后“浴缸”阻抗控制技术利用的是带预补偿的线性二次控制器(LQR)。线性二次控制器是众所周知并广泛使用的控制器,其可被实时设计,并将得到对组织阻抗和阻抗变化率的最佳控制。在一个方面,LQR控制器可按如下形式进行实施:
假设K是控制收益,r是一个期望的参考设定点,Nb是防止稳态误差的预补偿增益。从这个体系,速率上升可以被明确地控制。公式1中所示的二阶微分方程将针对b1和b2中每个值被降阶为两个一阶方程。然而,如果假定后“浴缸”能量应用的目标将导致(即,当t=0时,对于开始施加能量之后的所有时间值,Z>0),则可以假设控制器必须针对b=b2的情况来设计。在公式3中示出了一阶降阶:
设Z=U1并且
然后通过替换:
对于此类系统,可以通过将特定形式的成本函数降阶并求解Ricatti代数方程,来求得最优控制输入K。要被降阶的控制成本函数具有公式4中给出的形式,并且对于所有LQR控制器均是通用的。
R、N和Q是与要降阶的成本函数和控制器性能相关的预定常数矩阵。它们由设计工程师选择,以调节控制器的性能。当这个过程完成后,由下式得出K:
K=R-1(BTP(t)+NT 公式5
在公式5中,P是公式6中代数Riccati方程的解:
ATP+PA-(P)B+N)R-1(BTP+NT)+Q=0 公式6
根据一个方面,在将模型拟合到实验数据点上时,诸如图46分别对于曲线2602和2604所示,可以使用公式5来创建将阻抗保持在稳态值r=250Ohm的最优控制器。图47示出了分别表示建模数据和实验数据的曲线2702和2704。如图47所示,控制器按照预期在拟合组织模型上执行,其中期望阻抗2706Z保持在250Ohm。对于图47所示的控制器,K=[1.92374.3321]并且Nb=[26.9532]。存在一系列适当的收益,并且可得到确定。同样,也可以确定用于模型开发的一系列可行的收益。
另外,控制器也可以被构造成能够作为跟踪控制器来操作,以通过在适当的时候更新参考r来调控Z。此类控制器的一个示例在图48中示出,其中曲线2802和2804分别表示模型化数据和实验数据,并且线2806是用于跟踪控制器的一个方面的期望阻抗。如图48所示,可以实现期望的组织阻抗,其中期望的阻抗基于组织阻抗的变化率。跟踪控制器的稳态性能可以通过将积分器结合到公式5所示的公式系统中来改善。
图49是用于识别组织类型并开发控制过程以根据组织阻抗来控制将能量模态应用于组织这一操作的方法的逻辑流程图2900。如本文所述,逻辑流程图2900可在发生器500、多功能外科器械108或其组合中实施。现在参照图49所示逻辑流程图2900,组织夹持在外科器械108的端部执行器125的夹持臂145和超声刀149之间。根据该方法,发生器500可能无法确定位于夹持臂145和端部执行器125的超声刀149之间的组织类型。根据该方法,处理器502发送信号通知波形发生器504将能量模态传送2902到外科器械108的端部执行器125。处理器502测量2904组织阻抗。能量模态的应用在处理器502确定组织阻抗与预定阈值组织阻抗相匹配之后停止2906。处理器502至少部分地基于所测得的组织阻抗来估计2908至少一个组织参数。根据各个方面,所述至少一个组织参数包括组织类型、组织量、组织状态或它们的组合。处理器502基于估计的至少一个组织参数而求出2910参数化的组织模型,并基于该参数化的组织模型而生成2912用于应用能量模态的控制技术。因此,能量模态可以根据控制过程而被应用于另一个组织部分。
在另一方面,生成控制过程可以包括将特定组织特性与向组织应用能量模态相关。此外,可以实时生成控制过程,使其可容易地用于对组织的进一步应用。另外,控制过程可以被构造成能够应用能量模态,使得组织阻抗与预定阈值或预定的变化率相匹配。
由RF阻抗轨迹控制的超声输出
在一个方面中,本发明提供了由RF阻抗轨迹控制的超声输出,以控制来自发生器诸如发生器102,200,300,400,500中的任一者(图1至图3以及图4至图8)或外科器械108(图1至图3)的功率输出。传送到外科器械的端部执行器的功率可以基于组织RF阻抗轨迹而变化。为了使公开内容简洁和清楚,将参照图2中联接到图8的发生器500的外科器械108来描述用于由RF阻抗轨迹控制的超声输出以控制来自发生器的功率输出的技术,但是应当理解,在不脱离本公开的范围的情况下,可以容易地替换本文所述的器械、发生器和端部执行器的其他构型。
根据一个方面,外科器械可使用RF能量模式来感测组织特性(诸如阻抗)以及组织特性的变化,以调制超声组织处理系统的输出功率。具体地讲,外科器械的输出功率可以为期望的阻抗轨迹的函数来调制,其中该阻抗轨迹带来了期望的组织效应或结果。RF输出可以是治疗性的,例如组织治疗或亚治疗性的(例如仅感测)。此外,Rf输出可被施加到组织,并且电压和电流、或者电压和电流的表示受到测量或估计。另外,可以通过确定电压与电流的比例来计算阻抗。
图50是用于处理组织的方法的逻辑流程图3000。如本文所述,逻辑流程图3000可在发生器500、多功能外科器械108或其组合中实施。现在参照图50所示逻辑流程图3000,组织夹持在外科器械108的端部执行器125的夹持臂145和超声刀149之间。根据该方法,处理器502发送信号通知波形发生器504将能量模态传送3002到外科器械108的端部执行器125。根据各个方面,能量模态可以是RF能量模态或超声能量模态或它们的混合式组合,并且幅度可以是治疗幅度、亚治疗幅度或其组合。处理器502测量3004组织阻抗并且向波形发生器504发送信号通知,以基于所测得的组织阻抗来调制3006所选择的能量模态的传送。最终,处理器502发送信号通知波形发生器504在满足或超过对应于组织参数(例如密封完成)的终止阻抗阈值时停止3008应用能量模态。能量模态的应用可以在组织阻抗与组织阻抗的预定阈值或组织阻抗的预定阈值变化率相匹配时停止。组织阻抗可由处理器502通过将联接在标为ENERGY2/RETURN的端子两端的第二电压感测电路524的输出除以与电力变压器508的次级侧的返回支路串联设置的电流感测电路514的输出来确定,如图8所示。
根据逻辑流程图3000,外科器械108还可基于测量初始组织阻抗、端部执行器的初始钳口口径、当前组织阻抗,组织阻抗变化率、被驱动到组织中的能量的量、用于能量模态的处理时间中的至少一个来确定组织被密封,并且/或者基于所测得的组织的组织阻抗来确定组织的状态。组织的状态可包括例如凝固、密封或切割中的一种。
基于所测得的组织阻抗来调制能量模态的应用可以包括,应用能量模态使得组织阻抗根据预定过程而改变。在各个方面,预定过程包括组织的组织阻抗的预定阈值,或组织的组织阻抗的预定阈值变化率。在另一方面,基于所测得的组织阻抗调制能量模态的应用包括:修改发生器的输出功率、修改发生器的输出波形、选择要应用于组织的另一能量模态,以及修改终止参数。另外,能量模态可以是第一能量模态,并且该方法还包括以第二振幅向组织应用第二能量模态。第一能量模态可以是RF能量模态,而第二能量模态可以是超声能量模态
在另一方面,发生器500可以包括超声输出端(ENERGY1/RETURN),其被构造成能够将驱动信号传送到联接至外科器械108的超声刀149的超声换能器120。发生器500还可以包括RF输出端(ENERGY2/RETURN),其被构造成能够将电外科RF驱动信号传送到位于外科器械108的臂145中的至少一个电极。发生器500还可以包括感测电路,诸如被构造成能够测量组织阻抗的第二电压感测电路524和电流感测电路514,以及处理器502,其被构造成能够基于所测得的组织的组织阻抗和所测得的组织阻抗的预定变化来确定是否发生组织反应。波形发生器504和放大器506由处理器502控制,以在发生器500中被标记为(ENERGY1/RETURN)和(ENERGY2/RETURN)的相应输出端处提供必要的超声能量或RF能量模态。
超声刀149的组织处理部分被构造成能够将超声能量施加到组织以影响组织的处理,并且组织治疗部分的超声幅度由处理器502控制。所述至少一个电极被构造成能够从发生器500输出端接收RF能量,并且经由电极将RF能量施加到组织。电外科RF能量的幅度由处理器502控制。在一个方面,组织反应的确定对应于组织中流体的沸点。而且,处理器502可以被构造成能够生成目标阻抗轨迹,该生成目标阻抗轨迹为所测得的组织阻抗和组织阻抗的预定的期望变化率以及组织组织反应确定情况的函数。目标阻抗轨迹包括用于多个时间点中的每个时间点的多个目标阻抗值。此外,处理器502可以被构造成能够通过调节超声刀149的组织处理部分的超声幅度,而随目标阻抗轨迹来驱动组织阻抗,使组织阻抗与预定组织阻抗值基本上相匹配达预定时间段。
本文还公开了用于基于与端部执行器(诸如外科器械108的端部执行器)接合的组织的组织阻抗而动态地改变传送自发生器的能量的控制过程。根据一个方面,用于控制传送到外科器械108的端部执行器125的来自发生器(诸如图8的发生器500)的功率输出的过程可以包括,表示与外科器械108的端部执行器125接合的组织的组织阻抗的输入。在组织治疗过程期间,来自发生器500的能量分布曲线可基于组织阻抗而在RF能量和超声能量之间动态地改变。这允许发生器500基于正在受处理的组织的组织阻抗而从RF能量切换到超声能量。例如,当RF能量从发生器500被传送到外科器械108的端部执行器125时,组织阻抗与产生适当的凝固密封相关,使得当存在足够的组织阻抗时应使用RF能量。因此,在一个方面,当未发现特定的组织阻抗并且不存在足够的组织阻抗来启动组织上的RF能量模态以进行适当的凝固或密封时,可以将超声能量传送到端部执行器125,以将组织阻抗提高至可使RF能量模态得到传送以实现密封的水平。
能量参数被构造成能够加载到发生器500中,并且可以包括多个不同的参数,包括但不限于电压、电流、功率以及用于处理组织的一个或多个过程。这些参数可与能够传送自发生器500的RF能量和超声能量有关,并且因此可以基于与外科装置接合的组织的组织阻抗。能量参数可以包括用于控制从发生器500传送的能量的信息,诸如最大值和/或最小值。能量参数可以存储在多个位置,包括外科器械108上的EEPROM或一些其他非易失性存储器。另外,可存在多组能量参数。例如,可存在用于优化组织横切的第一组能量参数和用于优化组织点凝聚的第二组能量参数。应当理解,可存在任意数量的能量参数组对应于各种类型的组织处理,以允许发生器基于必要的组织处理在各组能量参数之间切换。
应当理解,可以使用各种信息组合来确定在组织处理期间要使用哪组能量参数。例如,可以使用端部执行器的口径和所计算的组织阻抗,确定需要哪一组能量参数来控制从发生器传送的能量。
在另一方面,用于控制从发生器(诸如图8的发生器)传送到外科器械端部执行器的功率输出的过程可以包括一个输入,该输入包括与外科器械的端部执行器所处理的组织大小相关的输入。在该规程期间,可以基于RF能量在凝固大组织时的有效性的确定,动态地在RF能量和超声能量之间改变发生器所传送的能量,以实现大组织的解剖和凝固。确定RF能量在凝固大脉管和大组织束中的有效性包括:如上所述计算与端部执行器相互作用的大组织的组织阻抗,该组织阻抗被用于确定由发生器传送到端部执行器的能量的类型。
虽然上文说明已列举了各种细节,但应当理解,用于医疗装置的串行通信协议的各个方面可在没有这些具体细节的情况下实施。例如,为简洁和清楚起见,以框图的形式示出了选择的方面,而不是详细地示出。本文提供的详细描述的某些部分可以呈现为对存储在计算机存储器中的数据进行操作的指令。本领域的技术人员用此类描述和表达向本领域的其他技术人员描述和传达他们的工作要旨。通常,技术是指导致所需结果的步骤的自相容序列,其中“步骤”是指物理量的操纵,物理量可以(但不一定)采用能被存储、传送、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联并且仅仅是应用于这些量的方便的标签。
除非上述讨论中另外明确指明,否则可以理解的是,在上述描述中,使用术语如“处理”或“估算”或“计算”或“确定”或“显示”的讨论是指计算机系统或类似的电子计算设备的动作和处理,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、传送或显示设备内的物理量的其他数据。
值得一提的是,任何对“一个方面(one aspect)”、“一方面(an aspect)”、“一种形式(one form)”、“一形式(an form)”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,出现在整篇说明书中的不同位置中的短语“在一个方面(in one aspect)”、“在一方面(in an aspect)”、“在一种形式中(in one form)”或“在一形式中(in an form)”不一定都是指同一方面。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。
一些方面可使用表达“联接”和“连接”连同其衍生词来描述。应当理解,并不希望这些术语彼此同义。例如,某些方面可使用术语“连接”来描述,以表示两个或更多个元件彼此直接物理接触或电接触。在另一个示例中,一些方面可使用术语“联接”来描述,以表示两个或更多个元件直接物理接触或电接触。然而,术语“联接”还可以指两个或更多个元件彼此不是直接接触,而是彼此配合或相互作用。
虽然本文描述了各种形式,但可以实现那些形式的多种修改形式、变型形式、替代形式、变化形式和等同形式,这些形式是本领域技术人员将会想到的。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随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和变型形式。以下权利要求旨在涵盖所有此类修改形式和变型形式。
在一般意义上,本领域的技术人员将会认识到,可以用多种硬件、软件、固件或它们的任何组合单独和/或共同实施的本文所述的多个方面可以被看作是由多种类型的“电子电路”组成。因此,如本文所用,“电子电路”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。
上述具体实施方式已通过使用框图、流程图和/或例子阐述了设备和/或方法的多个形式。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。在一种形式中,本文所述的主题的若干部分可以通过专用集成电路(ASIC)、现场可编程门阵列(FPGA)、数字信号处理器(DSP)或其它集成格式来实施。然而,本领域的技术人员将会认识到,本文所公开的形式的一些方面可以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。信号承载介质的例子包括但不限于:可记录型介质,诸如软盘,硬盘驱动器,光盘(CD),数字视频盘(DVD),数字磁带,电脑内存等;以及传输型介质,诸如数字和/或模拟通信介质(例如,光纤电缆、波导、有线通信链路、无线通信链路(例如,发射器、接收器、传输逻辑、接收逻辑等)等)。
上述美国专利、美国专利申请公开、美国专利申请、国外专利、国外专利申请、本说明书中所提及和/或任何应用数据表中所列出的非专利申请或任何其它公开材料均在不与其相抵触的程度上以引用方式并入本文。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与现有的公开材料之间不产生冲突的程度下并入。
本领域技术人员将会认识到,本文所述的组成部分(例如,操作)、装置、对象和它们随附的论述是为了概念清楚起见而用作示例,并且可以设想多种构型修改形式。因此,如本文所用,阐述的具体示例和随附的论述旨在代表它们更一般的类别。通常,任何具体示例的使用旨在代表其类别,并且具体组成部分(例如,操作)、装置和对象的未纳入部分不应采取限制。
对于本文中使用的基本上任何复数和/或单数术语,本领域技术人员可从复数转换成单数和/或从单数转换成复数,只要适合于上下文和/或应用即可。为清楚起见,各种单数/复数置换在本文中没有明确表述。
本文所述的主题有时示出了包含在不同的其他部件内或与不同的其他部件连接的不同部件。应当理解,这样描述的架构仅是示例,并且事实上可以实施实现获得相同功能性的许多其他架构。在概念意义上,获得相同功能性的组件的任何布置结构方式都是有效“相联的”,从而获得所需的功能性。因此,本文中为获得特定功能性而结合在一起的任何两个组件都可被视为彼此“相联”,从而获得所需的功能性,而不论结构或中间组件如何。同样,如此相关联的任何两个部件也可视为彼此“操作地连接”或“操作地联接”,以获得所需的功能性,并且能够如此相关联的任何两个部件都可视为彼此“可操作地联接”,以获得所需的功能性。可操作地联接的具体示例包括但不限于可物理匹配的和/或物理交互式部件,和/或可无线交互的和/或无线交互式部件,和/或逻辑交互的和/或可逻辑交互式部件。
在一些情况下,一个或多个部件在本文中可被称为“被构造成能够”、“可被构造成能够”、“可操作/可操作地”、“适合/适于”、“能够”、“适应/适合”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“被构造成能够”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。
虽然已经示出并描述了本文所述的本发明主题的特定方面,但是对本领域的技术人员将显而易见的是,基于本文的教导,可在不脱离本文所述的主题的情况下作出改变和变型,并且如在本文所述的主题的真实实质和范围内,其更广泛的方面并因此所附权利要求将所有此类改变和变型包括在其范围内。本领域的技术人员应当理解,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叙述。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”引入权利要求叙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。对于使用用于引入权利要求叙述的定冠词也是如此。
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中的至少一项等”的惯例的那些情况下,一般而言,这种结构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中的至少一项的系统”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)。在其中使用类似于“A、B或C中的至少一项等”的惯例的那些情况下,一般而言,这种结构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中的至少一项的系统”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,尽管以一定顺序列出了多个操作流程,但应当理解,可以不同于所示顺序的其他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。
虽然本文描述了各种形式,但可以实现那些形式的多种修改形式、变型形式、替代形式、变化形式和等同形式,这些形式是本领域技术人员将会想到的。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随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和变型形式。以下权利要求旨在涵盖所有此类修改形式和变型形式。
总而言之,已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。所述说明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。旨在与本申请一起提交的权利要求书限定整体范围。
Claims (40)
1.一种用于治疗组织的方法,包括:
通过驱动电路以一幅度向外科器械传送能量信号;
通过处理器测量与所述外科器械接合的组织的组织阻抗;
通过所述处理器基于所测得的组织阻抗来调制所述能量信号的传送;以及
当满足终止参数时停止传送所述能量信号。
2.根据权利要求1所述的方法,其中所述能量信号是RF能量信号,并且其中所述幅度是治疗幅度或者亚治疗幅度。
3.根据权利要求1所述的方法,还包括基于测量以下项中的至少一项来确定所述组织被密封:
初始组织阻抗;
端部执行器的初始钳口口径;
当前组织阻抗;
组织阻抗的变化率;
被驱动到所述组织中的超声能量;
被驱动到所述组织中的RF能量;和
处理时间。
4.根据权利要求1所述的方法,其中所述能量信号是RF能量信号或超声能量信号。
5.根据权利要求1所述的方法,其中所述能量信号包括第一能量信号,并且其中基于所测得的组织阻抗来调制所述能量信号的传送包括:修改发生器的输出功率、修改所述发生器的输出波形、选择要传送到所述外科器械的第二能量信号,或者修改所述终止参数。
6.根据权利要求1所述的方法,其中当满足所述终止参数时停止传送所述能量信号包括在所述组织阻抗与组织阻抗的阈值相匹配时停止传送所述能量信号。
7.根据权利要求1所述的方法,其中所述能量信号包括第一能量信号,其中所述幅度是第一幅度,并且所述方法还包括以第二幅度向组织传送第二能量信号。
8.根据权利要求7所述的方法,其中所述第一能量信号是RF能量信号,并且所述第二能量信号是超声能量信号。
9.根据权利要求1所述的方法,其中测量所述组织的组织阻抗包括测量所述组织的所述组织阻抗的变化率。
10.根据权利要求1所述的方法,还包括基于所测得的所述组织的组织阻抗来确定所述组织的状态。
11.根据权利要求10所述的方法,其中所述组织的所述状态包括凝固、密封或切割。
12.根据权利要求1所述的方法,其中基于所测得的组织阻抗来调制所述能量信号的传送包括将所述能量信号传送到所述外科器械以使所述组织阻抗根据预定技术而改变。
13.根据权利要求12所述的方法,其中所述预定技术包括根据所述组织的组织阻抗的阈值或所述组织的组织阻抗的阈值变化率来改变所述组织阻抗。
14.一种用于凝固和解剖组织的外科器械,所述外科器械包括:
处理器;
在所述外科器械的远侧端部处的端部执行器,所述端部执行器被构造成能够与组织相互作用,所述端部执行器包括:
包括电极的夹持臂;
超声刀;
超声换能器,所述超声换能器声学地联接到所述超声刀,并且被构造成能够从发生器接收驱动信号以引起所述超声刀的超声运动并将超声能量传送到所述超声刀;
其中所述处理器被构造成能够:
控制以一幅度向所述电极传送RF能量,或者控制以一幅度向所述超声刀传送超声能量;
测量与所述外科器械接合的组织的组织阻抗;
基于所测得的组织阻抗来调制所述RF能量的传送或所述超声能量的传送;以及
当满足终止参数时停止所述RF能量的传送或所述超声能量的传送。
15.根据权利要求14所述的外科器械,其中所述终止参数对应于所述组织中的流体的沸点。
16.根据权利要求14所述的外科器械,其中所述处理器被构造成能够生成目标阻抗轨迹,所述目标阻抗轨迹为所测得的组织阻抗和组织阻抗的预定的期望变化率的函数。
17.根据权利要求16所述的外科器械,其中所述目标阻抗轨迹包括用于多个时间点中的每个时间点的多个目标组织阻抗值。
18.根据权利要求16所述的外科器械,其中所述处理器被构造成能够通过调节被传送到所述超声刀的所述超声能量而随所述目标阻抗轨迹来驱动组织阻抗,使得所述组织阻抗与预定组织阻抗值相匹配达预定时间段。
19.一种用于将能量传送到用于凝固和解剖组织的外科器械的发生器,所述外科器械包括位于其远侧端部处的端部执行器,所述端部执行器被构造成能够与组织相互作用,所述端部执行器包括夹持臂、超声刀、超声换能器,所述超声换能器声学地联接到所述超声刀,并且被构造成能够从所述发生器接收驱动信号以引起所述超声刀的超声运动并将超声能量传送到所述超声刀,所述发生器包括:
第一驱动电路,所述第一驱动电路被构造成能够将驱动信号传送到超声换能器;
第二驱动电路,所述第二驱动电路被构造成能够将射频(RF)能量传送到所述电极;和
处理器,所述处理器被构造成能够控制所述第一驱动电路和所述第二驱动电路,并且其中所述处理器被构造成能够:
控制所述第二驱动电路以一幅度向所述电极传送RF能量,或者控制所述第一驱动电路以一幅度向所述超声刀传送超声能量;
测量与所述外科器械接合的组织的组织阻抗;
基于所测得的组织阻抗,控制所述第二驱动电路调制所述RF能量的传送,或者控制所述第一驱动电路调制所述超声能量的传送;以及
在满足终止参数时,控制所述第二驱动电路停止传送所述RF能量,或控制所述第一驱动电路停止传送所述超声能量。
20.根据权利要求19所述的发生器,其中所述处理器被构造成能够生成目标阻抗轨迹,所述目标阻抗轨迹为所测得的组织阻抗和组织阻抗的预定的期望变化率的函数。
21.一种用于处理组织的方法,包括:
通过驱动电路向外科器械传送能量信号;
测量与所述外科器械接合的组织的组织阻抗;
在所述组织阻抗与阈值阻抗值相匹配时停止传送所述能量信号;
至少部分地基于所测得的所述组织的组织阻抗来估计至少一个组织参数;
基于估计的所述至少一个组织参数来生成参数化的组织模型;以及
基于所述参数化的组织模型来生成用于传送所述能量信号的控制技术。
22.根据权利要求21所述的方法,还包括根据所述控制技术来传送所述能量信号。
23.根据权利要求21所述的方法,其中生成所述控制技术包括使特定组织特性与所述能量信号的传送相关。
24.根据权利要求21所述的方法,其中生成所述控制技术包括实时生成所述控制技术。
25.根据权利要求21所述的方法,其中所述控制技术能够传送所述能量信号,使得所述组织阻抗与阈值阻抗值相匹配。
26.根据权利要求21所述的方法,其中所述控制技术能够传送所述能量信号,使得所述组织阻抗与预定的变化率相匹配。
27.根据权利要求21所述的方法,其中所述至少一个组织参数包括组织类型、组织量、组织状态或它们的组合。
28.一种用于凝固和解剖组织的外科器械,所述外科器械包括:
处理器;
在所述外科器械的远侧端部处的端部执行器,所述端部执行器被构造成能够与组织相互作用,所述端部执行器包括:
包括电极的夹持臂;
超声刀;
超声换能器,所述超声换能器声学地联接到所述超声刀,并且被构造成能够从发生器接收驱动信号以引起所述超声刀的超声运动并将超声能量传送到所述超声刀;
其中所述处理器被构造成能够:
控制RF能量到所述电极的传送,或者控制超声能量到所述超声刀的传送;
测量与所述端部执行器接合的组织的组织阻抗;
当所述组织阻抗与阈值阻抗值相匹配时,停止将RF能量传送到所述电极,或者停止将超声能量传送到所述超声刀;
至少部分地基于所测得的所述组织的组织阻抗来估计至少一个组织参数;
基于估计的所述至少一个组织参数来生成参数化的组织模型;以及
基于所述参数化的组织模型来生成用于将RF能量传送到所述电极或将超声能量传送到所述超声刀的控制技术。
29.根据权利要求28所述的外科器械,其中所述处理器被构造成能够根据所述控制技术来控制RF能量到所述电极的传送,或者控制超声能量到所述超声刀的传送。
30.根据权利要求28所述的外科器械,其中所述处理器被构造成能够将特定组织特性与RF能量到所述电极的传送或超声能量到所述超声刀的传送相关。
31.根据权利要求28所述的外科器械,其中所述处理器被构造成能够实时生成所述控制技术。
32.根据权利要求28所述的外科器械,其中所述控制技术能够控制RF能量到所述电极的传送或超声能量到所述超声刀的传送,以使所述组织阻抗与阈值阻抗值相匹配。
33.根据权利要求28所述的外科器械,其中所述控制技术能够控制RF能量到所述电极的传送或超声能量到所述超声刀的传送,以使所述组织阻抗与预定的变化率相匹配。
34.根据权利要求28所述的外科器械,其中所述至少一个组织参数包括组织类型、组织量、组织状态或它们的组合。
35.一种用于将能量传送到用于凝固和解剖组织的外科器械的发生器,所述外科器械包括位于其远侧端部处的端部执行器,所述端部执行器被构造成能够与组织相互作用,所述端部执行器包括夹持臂、超声刀、超声换能器,所述超声换能器声学地联接到所述超声刀,并且被构造成能够从所述发生器接收驱动信号以引起所述超声刀的超声运动并将超声能量传送到所述超声刀,所述发生器包括:
第一驱动电路,所述第一驱动电路被构造成能够将驱动信号传送到超声换能器;
第二驱动电路,所述第二驱动电路被构造成能够将射频(RF)能量传送到所述电极;和
处理器,所述处理器被构造成能够控制所述第一驱动电路和所述第二驱动电路,并且其中所述处理器被构造成能够:
控制所述第二驱动电路将RF能量传送到所述电极,或者控制所述第一驱动电路将超声能量传送到所述超声刀;
测量与所述端部执行器接合的组织的组织阻抗;
当所述组织阻抗与阈值阻抗值相匹配时,停止将RF能量传送到所述电极,或者停止将超声能量传送到所述超声刀;
至少部分地基于所测得的所述组织的组织阻抗来估计至少一个组织参数;
基于估计的所述至少一个组织参数来生成参数化的组织模型;以及
基于所述参数化的组织模型来生成用于将RF能量传送到所述电极或将超声能量传送到所述超声刀的控制技术。
36.根据权利要求35所述的发生器,其中所述处理器被构造成能够根据所述控制技术来控制RF能量到所述电极的传送,或者控制超声能量到所述超声刀的传送。
37.根据权利要求35所述的发生器,其中所述处理器被构造成能够将特定组织特性与RF能量到所述电极的传送或超声能量到所述超声刀的传送相关。
38.根据权利要求35所述的发生器,其中所述处理器被构造成能够实时生成所述控制技术。
39.根据权利要求35所述的发生器,其中所述控制技术能够控制RF能量到所述电极的传送或超声能量到所述超声刀的传送,以使所述组织阻抗与阈值阻抗值相匹配。
40.根据权利要求35所述的发生器,其中所述控制技术能够控制RF能量到所述电极的传送或超声能量到所述超声刀的传送,以使所述组织阻抗与预定的变化率相匹配。
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WO2017003854A3 (en) | 2017-03-02 |
BR112017028403A2 (pt) | 2018-08-28 |
JP2018519918A (ja) | 2018-07-26 |
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BR112017028403B1 (pt) | 2022-12-20 |
JP6797847B2 (ja) | 2020-12-09 |
US10898256B2 (en) | 2021-01-26 |
EP3316810B1 (en) | 2023-11-01 |
MX2018000194A (es) | 2018-04-11 |
EP4282343A2 (en) | 2023-11-29 |
EP3316810A2 (en) | 2018-05-09 |
EP3316810C0 (en) | 2023-11-01 |
US20170000542A1 (en) | 2017-01-05 |
CN107847263B (zh) | 2021-03-09 |
WO2017003854A2 (en) | 2017-01-05 |
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