CN108697457B - 包括细长多层轴的模块化电池供电手持式外科器械 - Google Patents

包括细长多层轴的模块化电池供电手持式外科器械 Download PDF

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CN108697457B
CN108697457B CN201780011858.XA CN201780011858A CN108697457B CN 108697457 B CN108697457 B CN 108697457B CN 201780011858 A CN201780011858 A CN 201780011858A CN 108697457 B CN108697457 B CN 108697457B
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shaft
assembly
circuit
surgical instrument
coupled
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CN108697457A (zh
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F·E·谢尔顿四世
D·C·耶茨
K·L·豪泽
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Ethicon LLC
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Ethicon LLC
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Abstract

本发明提供了一种包括外科器械的系统,所述外科器械包括柄部组件,所述柄部组件包括柄部;轴组件,所述轴组件联接到所述柄部组件;以及柔性电路。所述柄部组件包括所述柔性电路的近侧部分,并且所述轴组件包括所述柔性电路的远侧部分;轴组件还包括:外轴,所述外轴围绕所述柔性电路的所述远侧部分定位并且被构造成能够在所述柔性电路的所述远侧部分的子部分保持静止时改变位置;以及轴控制电子器件,所述轴控制电子器件包括固定部分和非固定部分,所述固定部分联接到所述柔性电路的所述远侧部分,并且所述非固定部分联接到所述外轴;其中所述轴控制电子器件的所述固定部分被构造成能够在所述外轴改变位置时测量到所述轴控制电子器件的所述非固定部分的距离。

Description

包括细长多层轴的模块化电池供电手持式外科器械
优先权
本申请要求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,这些临时申请中的每一个的内容以引用方式全文并入本文。
背景技术
本公开整体涉及外科器械和相关联的外科技术。更具体地讲,本公开涉及允许外科医生执行切割和凝固并且基于被处理的组织的类型来调整和定制此类手术的超声和电外科系统。
超声外科器械凭借此类器械的独特性能特性而在外科规程中得到日益广泛的应用。根据具体器械构造和操作参数,超声外科器械能够同时或基本上同时切割组织和通过凝固进行止血,从而有利地使患者创伤最小化。切割动作通常通过器械的远侧端部处的端部执行器或刀头来实现,所端部执行器或刀头将超声能量传输到与该端部执行器接触的组织。该性质的超声器械可被构造用于开放性科手术用途、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进行切割和凝固。通过高频振动(例如,每秒55,500次),超声刀使组织中的蛋白变性以形成粘性凝固物。刀表面施加到组织上的压力使血管塌缩并且允许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水平、刀刃、组织牵引力和刀压力的调节的控制。
用于将电能施加到组织以治疗和/或破坏组织的电外科器械也在外科规程中得到日益广泛的应用。电外科器械通常包括手持件,所述手持件是一种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。电外科器械可被构造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且通过单独设置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。电外科器械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。
由电外科器械施加的电能可通过与手持件连通的发生器传递至器械。电能可为射频(“RF”)能量的形式。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,电外科器械可穿过组织传递低频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结缔组织,所述结缔组织主要由胶原构成并且在接触热时收缩。
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完全控制和定制外科器械的功能。期望提供一种克服当前器械的某些缺陷的外科器械。
发明内容
在一个方面,本公开提供一种包括外科器械的系统。外科器械包括柄部组件,该柄部组件包括柄部;轴组件,该轴组件联接到柄部组件;以及柔性电路,其中柄部组件包括柔性电路的近侧部分,并且轴组件包括柔性电路的远侧部分;轴组件还包括:外轴,该外轴围绕柔性电路的远侧部分定位并且被构造成能够在柔性电路的远侧部分的至少一个子部分保持固定时改变位置;以及轴控制电子器件,所述轴控制电子器件包括固定部分和非固定部分,固定部分联接到柔性电路的远侧部分,并且非固定部分联接到外轴;其中轴控制电子器件的固定部分被构造成能够在外轴改变位置时测量到轴控制电子器件的非固定部分的距离。
在另一方面,本发明提供了一种外科器械,该外科器械包括柄部组件,该柄部组件包括柄部;轴组件,该轴组件联接到柄部组件;以及柔性电路,其中柄部组件包括柔性电路的近侧部分,并且轴组件包括柔性电路的远侧部分;轴组件还包括:外轴,该外轴围绕柔性电路的远侧部分定位并且被构造成能够在柔性电路的远侧部分的至少一个子部分保持固定时改变位置;以及轴控制电子器件,所述轴控制电子器件包括固定部分和非固定部分,固定部分联接到柔性电路的远侧部分,并且非固定部分联接到外轴;其中轴控制电子器件的固定部分被构造成能够在外轴改变位置时测量到轴控制电子器件的非固定部分的距离。
在另一方面,本公开提供了一种计算机可读介质,该计算机可读介质不具有包括指令的暂时性信号,所述指令在由处理器执行时使得处理器执行包括柄部组件、轴组件和柔性电路的外科器械的操作,该操作包括在轴组件保持固定时接收轴组件中的轴控制电子器件的固定部分与轴控制电子器件的非固定部分之间的第一距离;当轴组件的固定部分保持固定时,使轴组件的非固定部分改变位置;当轴组件的非固定部分改变位置时,接收轴控制电子器件的固定部分和轴控制电子器件的非固定部分之间的第二距离;并且基于第一距离和第二距离之间的比较来计算轴组件的非固定部分的位置变化。
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它方法和/或系统和/或程序产品方面。
上述内容是概述,因此可包括细节的简化、概括、纳入和/或省略;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。本文描述的装置和/或过程和/或其它主题的其它方面、特征和优点将在本文列出的教导内容中变得显而易见。
在一个或多个不同方面,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/或编程实际上可为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/或固件的任何组合。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它方法和/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。
上述发明内容仅为例示性的,并非旨在以任何方式进行限制。除上述例示性方面和特征之外,参考附图和下述详细说明,其它方面和特征将变得显而易见。
附图说明
本文所述各个方面的新颖特征在所附权利要求书中进行了具体阐述。然而,关于组织和操作方法的各个方面可结合如下附图参考下述说明更好地理解。
图1为根据本公开的方面的模块化电池供电手持式超声外科器械的示图。
图2为根据本公开的方面的图1所示外科器械的分解图。
图3为根据本公开的方面的图1所示外科器械的模块化轴组件的分解图。
图4为根据本公开的方面的图1所示外科器械的超声换能器/发生器组件的透视透明图。
图5为根据本公开的方面的超声换能器/发生器组件的端视图。
图6为根据本公开的方面的超声换能器/发生器组件的透视图,其中顶部外壳部分被移除以暴露超声发生器。
图7为根据本公开的方面的超声换能器/发生器组件的剖视图。
图8为根据本公开的一个方面的超声换能器/发生器组件的正视图,该超声换能器/发生器组件被构造成能够以31kHz的谐振频率操作。
图9为根据本公开的一个方面的超声换能器/发生器组件的正视图,该超声换能器/发生器组件被构造成能够以55kHz的谐振频率操作。
图10A和图10B示出了根据本公开的一个方面的移位组件,该移位组件相对于超声换能器选择性地旋转超声传输波导并且将它们朝向彼此推动。
图11为根据本公开的一个方面的适用于驱动超声换能器的图4所示超声驱动电路的一个方面的示意图。
图12为根据本公开的一个方面的联接到图11所示超声驱动电路的变压器的示意图。
图13为根据本公开的一个方面的联接到测试电路的图12所示变压器的示意图。
图14为根据本公开的一个方面的控制电路的示意图。
图15示出了根据本公开的一个方面的简化电路框图,其示出了包含在模块化超声外科器械内的另一电路。
图16示出了根据本公开的一个方面的与外科器械一起使用的电池组件。
图17示出了根据本公开的一个方面的与外科器械一起使用的一次性电池组件。
图18示出了根据本公开的一个方面的与外科器械一起使用的可重复使用电池组件。
图19为根据本公开的一个方面的电池组件的立体透视图,其中壳体的两半被移除,暴露出联接到多个电路板的电池单元,所述多个电路板联接到多引线电池端子。
图20示出了根据本公开的一个方面的电池测试电路。
图21示出了根据本公开的一个方面的用以维持最小输出电压的补充功率源电路。
图22示出了根据本公开的一个方面的用于向外科器械供应能量的开关模式功率源电路。
图23示出了根据本公开的一个方面的用于向外科器械供应能量的图22所示切换调节器的分立型式。
图24示出了根据本公开的一个方面的用于向外科器械供应能量的线性功率源电路。
图25为根据本公开的一个方面的模块化手持式超声外科器械的正面分解图,其示出了左半壳从柄部组件被移除,暴露出通信地联接到多引线柄部端子组件的装置标识符。
图26为根据本公开的一个方面的图25所示超声外科器械的触发器部分和开关的详细视图。
图27为根据本公开的一个方面的来自远侧端部的端部执行器的局部放大透视图,其中钳口构件处于打开位置。
图28示出了根据本公开的一个方面的外科器械的模块化轴组件和端部执行器部分。
图29为根据本公开的一个方面的内管/弹簧组件的详细视图。
图30示出了根据本公开的一个方面的模块化电池供电手持式组合超声/电外科器械。
图31为根据本公开的一个方面的图30所示外科器械的分解图。
图32为根据本公开的一个方面的模块化电池供电手持式组合超声/RF外科器械的局部透视图。
图33示出了根据本公开的一个方面的结合图30至图32所述的外科器械的喷嘴部分。
图34为根据本公开的一个方面的被构造用于驱动高频电流(RF)的驱动电路的一个方面的示意图。
图35为根据本公开的一个方面的联接到图34所示RF驱动电路的变压器的示意图。
图36为根据本公开的一个方面的电路的示意图,该电路包括用于高功率能量/驱动电路和低功率电路的单独功率源。
图37示出了控制电路,该控制电路允许双发生器系统在RF发生器与超声发生器能量模态之间切换,以用于图30和图31所示的外科器械。
图38为根据本公开的一个方面的端部执行器的剖视图。
图39为根据本公开的一个方面的端部执行器的剖视图。
图40为根据本公开的一个方面的示出了处于闭合状态的远侧钳口节段的局部纵向侧剖视图。
图41为根据本公开的一个方面的示出了处于打开状态的远侧钳口节段的局部纵向侧剖视图。
图42为根据本公开的一个方面的示出了钳口构件的局部纵向侧剖视图。
图43为根据本公开的一个方面的示出了处于正常状态的远侧钳口节段的横剖视图。
图44为根据本公开的一个方面的示出了处于磨损状态的远侧钳口节段的横剖视图。
图45示出了根据本公开的一个方面的具有远侧关节运动件的模块化电池供电手持式电外科器械。
图46为根据本公开的一个方面的图45所示外科器械的分解图。
图47为根据本公开的一个方面的具有位于柄部组件上的显示器的图45和图46所示外科器械的透视图。
图48为根据本公开的一个方面的不具有位于柄部组件上的显示器的图45和图46所示器械的透视图。
图49为根据本公开的一个方面的可与外科器械一起使用以驱动刀的马达组件。
图50为根据本公开的一个方面的马达驱动电路的示图。
图51示出了根据本公开的一个方面的用以驱动远侧头部旋转、关节运动和钳口闭合的旋转驱动机构。
图52为根据本公开的一个方面的端部执行器组件的放大左侧透视图,其中钳口构件被示出处于打开构型。
图53为根据本公开的一个方面的图52的端部执行器组件的放大右侧视图。
图54示出了根据本公开的一个方面的具有远侧关节运动件的模块化电池供电手持式电外科器械。
图55为根据本公开的一个方面的图54所示外科器械的分解图。
图56为根据本公开的一个方面的包括电连接件的图54所示关节运动节段的放大区域细节图。
图57为根据本公开的一个方面的包括电连接件的图56所示关节运动节段的放大区域细节图。
图58示出了根据本公开的一个方面的图54的外科器械的轴组件、端部执行器和切割构件的部件的透视图。
图59示出了根据本公开的一个方面的第二级关节运动件中的关节运动节段。
图60示出了根据本公开的一个方面的处于打开构型的图54至图59的装置的端部执行器的透视图。
图61示出了根据本公开的一个方面的处于闭合构型并且具有远侧位置的刀的图60的端部执行器的横剖端视图。
图62示出了根据本公开的一个方面的外科器械的控制电路的部件。
图63为根据本公开的一个方面的包括多个独立操作的电路段的分段电路的系统图。
图63为直接数字合成电路的一种形式的示图。
图64示出了包括与本文结合图1至图61所述的任何一种外科器械一起使用的反馈系统的外科器械的一个方面的示图,该外科器械可包括或实现本文所述的许多特征。
图65示出了根据本公开的一个方面的用于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,该电路被构造成能够为电信号波形产生多个波形,以用于本文结合图1至图61所述的任何外科器械中。
图66示出了根据本公开的一个方面的直接数字合成(DDS)电路的一个方面,该电路被构造成能够为电信号波形产生多个波形,以用于本文结合图1至图61所述的任何外科器械中。
图67示出了根据本公开的一个方面的根据模拟波形(出于比较目的,被示出叠加在离散时间数字电信号波形上)的本公开的一个方面的离散时间数字电信号波形的一个周期。
图68A示出了根据本公开的一个方面的包括控制器的电路,该控制器包括联接到至少一个存储器电路的一个或多个处理器,以用于本文结合图1至图61所述的任何外科器械中。
图68B示出了根据本公开的一个方面的包括有限状态机的电路,该有限状态机包括被构造成能够实现本文所述的算法、过程或技术中的任一者的组合逻辑电路。
图68C示出了根据本公开的一个方面的包括有限状态机的电路,该有限状态机包括被构造成能够实现本文所述的算法、过程或技术中的任一者的时序逻辑电路。
图69为根据本公开的一个方面的具有马达控制功能的外科器械的各种部件的电路图。
图70示出了根据本公开的一个方面的柄部组件,其中可移除维修板被移除以示出柄部组件的内部部件。
图71示出了根据本公开的一个方面的在医疗装置的柄部组件和轴组件的一部分内部互连的轴控制电子器件的示例系统。
图72提供了根据本公开的一个方面、根据一些方面的柔性电路的放大部分的示例。
图73A和图73B示出了根据本公开的一个方面,多个传感器可以如何组合使用以测量和监测医疗装置的运动。
图74提供了根据本公开的一个方面的可以如何使用多个传感器来确定一个或多个磁体的三维位置的另一示例。
图75示出了根据本公开的一个方面的医疗装置的轴组件的变型,其包括用于保护敏感电子器件的密封件。
具体实施方式
本申请涉及以下与其同时提交的共同拥有专利申请,以下专利申请中的每一个的内容以引用方式全文并入本文:
2016年12月16日提交、发明人为Frederick E.Shelton,IV等人且名称为“MODULARBATTERY POWERED HANDHELD SURGICAL INSTRUMENT AND METHODS THEREFOR”的代理人案卷号END7911USNP/160006;
2016年12月16日提交、发明人为Frederick E.Shelton,IV等人且名称为“MODULARBATTERY POWERED HANDHELD SURGICAL INSTRUMENT WITH SELECTIVE APPLICATION OFENERGY BASED ON TISSUE CHARACTERIZATION”的代理人案卷号END7911USNP1/160006-1;
发明人为Frederick E.Shelton,IV等人且名称为“MODULAR BATTERY POWEREDHANDHELD SURGICAL INSTRUMENT WITH SELECTIVE APPLICATION OF ENERGY BASED ONBUTTON DISPLACEMENT,INTENSITY,OR LOCAL TISSUE CHARACTERIZATION”的代理人案卷号END7911USNP2/160006-2;
2016年12月16日提交、发明人为Frederick E.Shelton,IV等人且名称为“MODULARBATTERY POWERED HANDHELD SURGICAL INSTRUMENT WITH VARIABLE MOTOR CONTROLLIMITS”的代理人案卷号END7911USNP3/160006-3;
2016年12月16日提交、发明人为Frederick E.Shelton,IV等人且名称为“MODULARBATTERY POWERED HANDHELD SURGICAL INSTRUMENT WITH MOTOR CONTROL LIMITPROFILE”的代理人案卷号END7911USNP4/160006-4;
2016年12月16日提交、发明人为Frederick E.Shelton,IV等人且名称为“MODULARBATTERY POWERED HANDHELD SURGICAL INSTRUMENT WITH MOTOR CONTROL LIMITS BASEDON TISSUE CHARACTERIZATION”的代理人案卷号END7911USNP5/160006-5;
2016年12月16日提交、发明人为Frederick E.Shelton,IV等人且名称为“MODULARBATTERY POWERED HANDHELD SURGICAL INSTRUMENT WITH MULTI-FUNCTION MOTOR VIASHIFTING GEAR ASSEMBLY”的代理人案卷号END7911USNP6/160006-6;
2016年12月16日提交、发明人为Frederick E.Shelton,IV等人且名称为“MODULARBATTERY POWERED HANDHELD SURGICAL INSTRUMENT WITH A PLURALITY OF CONTROLPROGRAMS”的代理人案卷号END7911USNP7/160006-7;
2016年12月16日提交、发明人为Frederick E.Shelton,IV等人且名称为“MODULARBATTERY POWERED HANDHELD SURGICAL INSTRUMENT WITH ENERGY CONSERVATIONTECHNIQUES”的代理人案卷号END7911USNP8/160006-8;
2016年12月16日提交、发明人为Frederick E.Shelton,IV等人且名称为“MODULARBATTERY POWERED HANDHELD SURGICAL INSTRUMENT WITH VOLTAGE SAG RESISTANTBATTERY PACK”的代理人案卷号END7911USNP9/160006-9;
2016年12月16日提交、发明人为Frederick E.Shelton,IV等人且名称为“MODULARBATTERY POWERED HANDHELD SURGICAL INSTRUMENT WITH MULTISTAGE GENERATORCIRCUITS”的代理人案卷号END7911USNP10/160006-10;
2016年12月16日提交、发明人为Frederick E.Shelton,IV等人且名称为“MODULARBATTERY POWERED HANDHELD SURGICAL INSTRUMENT WITH MULTIPLE MAGNETIC POSITIONSENSORS”的代理人案卷号END7911USNP11/160006-11;
2016年12月16日提交、发明人为Frederick E.Shelton,IV等人且名称为“MODULARBATTERY POWERED HANDHELD SURGICAL INSTRUMENT WITH MOTOR DRIVE”的代理人案卷号END7911USNP13/160006-13;
2016年12月16日提交、发明人为Frederick E.Shelton,IV等人且名称为“MODULARBATTERY POWERED HANDHELD SURGICAL INSTRUMENT WITH SELF-DIAGNOSING CONTROLSWITCHES FOR REUSABLE HANDLE ASSEMBLY”的代理人案卷号END7911USNP14/160006-14;
2016年12月16日提交、发明人为Frederick E.Shelton,IV等人且名称为“MODULARBATTERY POWERED HANDHELD SURGICAL INSTRUMENT WITH REUSABLE ASYMMETRIC HANDLEHOUSING”的代理人案卷号END7911USNP15/160006-15;
2016年12月16日提交、发明人为Frederick E.Shelton,IV等人且名称为“MODULARBATTERY POWERED HANDHELD SURGICAL INSTRUMENT WITH CURVED END EFFECTORS HAVINGASYMMETRIC ENGAGEMENT BETWEEN JAW AND BLADE”的代理人案卷号END7911USNP16/160006-16。
在下述详细说明中,参考构成其一部分的附图。在附图中,除非上下文另外指出,否则类似的符号和参考字符通常在几个视图中标识相似的部件。详细说明、附图和权利要求中描述的例示性方面并非意在进行限制。在不脱离本文所呈现的主题范围的情况下,可使用其它方面,并且可作出其它改变。
在详细解释本发明的各个方面之前,应当指出的是,本文所公开的各个方面的应用或使用不限于附图和具体实施方式中示出的部件的构造和布置的细节。相反,所公开的方面可设置或结合在其它方面、它们的变型和修改形式中,并且可以多种方式实施或执行。因此,本文所公开的方面本质上是例示性的,而并非意在限制其范围或应用。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针对各方面进行描述的目的而选择的,并非限制其范围。另外,应当理解,所公开的方面、方面的表达和/或其实施例中的任何一个或多个可不受限制地与其它所公开的方面、方面的表达和/或其实施例中的任何一个或多个组合。
而且,在下述说明中,应当理解,术语诸如前、后、内部、外部、顶部、底部等是方便性词语,不应被解释为限制性术语。本文所用的术语并非意在限制在本文所述装置或其部分的范围内,而是可以按照其它取向附接或利用。将参考附图更详细地描述各个方面。
在各个方面,本公开涉及一种利用超声和RF能量模态两者的混合能量外科器械。该混合能量外科器械可使用模块化轴,该模块化轴能够实现现有端部执行器功能,诸如美国专利号9,107,690(其全文以引用方式并入本文)中公开的超声功能、美国专利号8,696,666和8,663,223(两者全文以引用方式并入本文)中公开的组合装置功能、美国专利号9,028,478和9,113,907(两者全文以引用方式并入本文)中公开的RF相对电极功能,以及专利申请公布号2013/0023868(其全文以引用方式并入本文)中公开的RF I-叶片偏移电极功能。
在各个方面,本公开涉及一种模块化电池供电手持式超声外科器械,该外科器械包括第一发生器、第二发生器以及用于控制由外科器械施加的能量模态的控制电路。该外科器械被构造成能够施加至少一种能量模态,该能量模态包括超声能量模态、射频(RF)能量模态或者超声能量模态和RF能量模态的组合。
在另一方面,本公开涉及一种模块化电池供电手持式外科器械,该外科器械可被构造用于超声能量模态、RF模态或者超声能量模态和RF能量模态的组合。混合能量外科器械利用超声能量模态和RF能量模态两者。混合能量外科器械可使用实现端部执行器功能的模块化轴。能量模态可基于具体所测量的组织和装置参数(诸如,电阻抗、组织阻抗、电动马达电流、钳口间隙、组织厚度、组织压缩、组织类型、温度等参数或它们的组合)的测量结果来选择,以确定合适的能量模态算法来利用超声振动和/或电外科高频电流,以基于由外科器械识别的所测量的组织参数来对活组织进行外科凝固/切割治疗。一旦已经识别组织参数,外科器械可被构造成能够通过测量具体组织/装置参数来在单个或分段RF电极构造中或者在超声装置中控制施加到组织的治疗能量。组织治疗算法在名称为“SURGICALINSTRUMENT WITH USER ADAPTABLE TECHNIQUES”的共同拥有美国专利申请号15/177,430中描述,该专利申请以引用方式全文并入本文。
在另一方面,本公开涉及一种具有马达和控制器的模块化电池供电手持式外科器械,其中第一限制阈值用于马达上以便附接模块化组件,并且第二阈值用于马达上并与外科器械的第二组装步骤或功能相关联。该外科器械可包括马达驱动的致动机构,该致动机构通过测量马达电流或与马达电流相关的参数来利用马达速度或扭矩的控制,其中经由非线性阈值调节马达控制以基于位置、惯性、速度、加速度或它们的组合来以不同幅度触发马达调节。可采用移动机构和马达控制器的马达驱动的致动来控制马达速度或扭矩。与移动机构的物理特性相关联的传感器向马达控制器提供反馈。在一个方面,采用传感器来调节触发马达控制器的操作变化的预定阈值。可利用马达来驱动轴功能诸如轴旋转和钳口闭合以及切换该马达,以还向换能器提供扭矩受限的波导附件。可利用马达控制算法来通过马达驱动系向用户产生触觉反馈,以指示装置状态和/或供电致动的限制。基于马达供电模块化先进能量的外科器械可包括一系列控制程序或算法,以操作一系列不同的轴模块和换能器。在一个方面,程序或算法位于模块中并且在附接时被上载到控制柄部。该马达驱动的模块化电池供电手持式外科器械可包括主旋转驱动器,该主旋转驱动器能够可选择地联接到至少两个独立的致动功能(第一致动功能、第二致动功能、两者、非两者),并且利用位于远侧模块化细长管中的离合器机构。
在另一方面,本公开涉及包括节能电路的模块化电池供电的手持式外科器械,以及使用睡眠模式来将具有短路的分段电路断电以最小化非使用功率消耗和使唤醒序列不同于睡眠序列顺序的技术。一次性一次电池组可与电池供电模块化手持式外科器械一起使用。一次性一次电池可包括功率管理电路,以利用附加电压补偿电池输出电压,从而抵消负载下的电压下降并防止电池组输出电压在负载下的操作期间下降到预定水平以下。该外科器械的电路包括耐辐射部件,并且电信号的放大可分成多级。超声换能器外壳或RF外壳可容纳最终放大级,并且可包括不同比率,具体取决于与超声换能器或RF模块相关联的能量模态。
在另一方面,本公开涉及一种模块化电池供电手持式外科器械,该外科器械包括沿轴的长度且以不同构造配对的多个磁位置传感器,以允许多个传感器检测同一磁体,以便根据固定参考平面确定轴的致动部件的三维位置,同时诊断来自外部源的任何误差。控制和感测电子器件可结合在轴中。轴控制电子器件的一部分可沿移动轴部件的内部设置,并且与沿移动轴部件的外部设置的其它轴控制电子器件分开。控制和感测电子器件可被定位和设计成使得它们充当装置中的轴密封。
在另一方面,本公开涉及一种模块化电池供电手持式外科器械,该外科器械包括电池供电模块化可重复使用柄部内的自诊断控制开关。该控制开关能够调节其用于触发事件的阈值,也能够指示对控件的外部影响或预测直到需要更换的时间。可重复使用柄部外壳被构造用于与模块化一次性轴以及至少一个控件和线束一起使用。柄部被构造成能够在打开时不对称地分开,以便开关、线束和/或控制电子器件可以可支撑地容纳在一侧,使得另一侧可移除地附接以覆盖主外壳。
图1为根据本公开的方面的模块化电池供电手持式超声外科器械100的示图。图2为根据本公开的方面的图1所示外科器械100的分解图。现在参考图1和图2,外科器械100包括柄部组件102、超声换能器/发生器组件104、电池组件106、轴组件110和端部执行器112。超声换能器/发生器组件104、电池组件106和轴组件110是可移除地连接到柄部组件102的模块化部件。柄部组件102包括马达组件160。另外,外科器械100的一些方面包括包含超声发生器和马达控制电路的电池组件106。电池组件106包括第一级发生器功能,其中末级作为超声换能器/发生器组件104的一部分存在,用于驱动55kHz和33.1kHz的超声换能器。用于与电池组件106、共用发生器部件和分段电路互换使用的不同末级发生器使电池组件106能够以受控方式向驱动电路的各节段供电,并且能够在向电路供电之前检查电路的级别并启用功率管理模式。另外,通用控件可设置在柄部组件102中,其中专用轴组件110控件位于具有那些功能的轴上。例如,端部执行器112模块可包括远侧旋转电子器件,轴组件110可包括旋转轴控件以及关节运动开关,并且柄部组件102可包括能量激活控件和钳口构件114触发器108控件,以夹持和松开端部执行器112。
超声换能器/发生器组件104包括外壳148、显示器176(诸如,液晶显示器(LCD))、超声换能器130和超声发生器162(图4)。轴组件110包括外管144、超声传输波导145和内管(未示出)。端部执行器112包括钳口构件114和超声刀116。如下文所述,可利用由触发器108操作的马达或其它机构来闭合钳口构件114。超声刀116是超声传输波导145的远侧端部。钳口构件114可枢转地旋转以抓持钳口构件与超声刀116之间的组织。钳口构件114可操作地联接到触发器108,使得当触发器108被挤压时,钳口构件114闭合以抓持组织,并且当触发器108被释放时,钳口构件114打开以释放组织。在一级触发器构造中,触发器108用于在触发器108被挤压时闭合钳口构件114,并且在触发器108被释放时打开钳口构件114。一旦钳口构件114闭合,开关120就被激活以对超声发生器通电,从而密封和切割组织。在两级触发器构造中,在第一级期间,触发器108被挤压部分路程以闭合钳口构件114,并且在第二级期间,触发器108被挤压剩余路程以对超声发生器通电,从而密封和切割组织。通过释放触发器108打开钳口构件114a,从而释放组织。应当理解,在其它方面,超声换能器103可在钳口构件114未闭合的情况下被激活。
电池组件106通过电连接器132电连接到柄部组件102。柄部组件102设置有开关120。通过致动开关120对超声换能器/发生器电路通电来激活超声刀116。根据一个方面,电池组件106是具有调节输出的可充电、可重复使用电池组。在一些情况下,如下文所述,电池组件106促进用户界面功能。柄部组件102是一次性单元,其具有用于附接到电池组件106、超声换能器/发生器组件104和轴组件110的凹处或底座。柄部组件102还容纳各种指示器,包括例如扬声器/蜂鸣器和激活开关。在一个方面,电池组件是单独的部件,其通过由柄部组件的外壳限定的门或其它开口插入柄部组件的外壳中。
超声换能器/发生器组件104是可重复使用单元,其在远侧输出处产生高频机械运动。超声换能器/发生器组件104机械地联接到轴组件110和超声刀116,并且在操作装置期间在超声刀116的远侧输出处产生运动。在一个方面,超声换能器/发生器组件104还诸如通过红/绿/蓝(RGB)发光二极管(LED)、LCD或其它显示器提供视觉用户界面。如此,电池状态的视觉指示器唯一不位于电池上,因此远离电池。
根据本公开的各个方面,外科器械100的三个部件(例如,超声换能器/发生器组件104、电池组件106和轴组件110)有利地可与一个或多个其它部件快速断开。外科器械100的三个部件中的每一个都是无菌的,并且在使用期间可完全保持在无菌区中。因为外科器械100的部件是可分离的,所以外科器械100可由作为单次使用(例如,一次性)物品的一个或多个部分和作为多次使用物品(例如,可灭菌以用于多次外科规程中)的其它部分组成。部件的各方面作为外科器械100的一部分分离。根据本公开的另一方面,柄部组件102、电池组件106和轴组件110这些部件的总重量相等;柄部组件102、电池组件106和轴组件110这些部件中的每一个都是平衡的,使得它们的重量相同或基本相同。柄部组件102向上伸出操作者的手以供支撑,从而允许使用者的手在不承受重量的情况下更自由地操作外科器械100的控件。该向上伸出部分被设定为非常接近重心。这与三角形组件构造相结合,使得外科器械100有利地设置有平衡中心,该平衡中心为操作装置的使用者提供了非常自然和舒适的感觉。也就是说,当被握在使用者的手中时,外科器械100不具有向前或向后或向两侧倾斜的倾向,而是保持相对动态平衡,使得使用者用极少的力就能使波导与地面保持平行。当然,可很容易地将器械放置为与地面成非平行角度。
旋钮118可操作地联接到轴组件110。使旋钮118在箭头126所示的方向上旋转±360°使得外管144在箭头128的相应方向上旋转±360°。在一个方面,旋钮118可被构造成能够在超声刀116保持静止时使钳口构件114旋转,并且可提供单独的轴旋转旋钮来使外管144旋转±360°。在各个方面,超声刀116不必停在±360°,并且可以大于±360°的旋转角度旋转。外管144可具有在例如5mm至10mm范围内的直径D1
超声刀116通过位于轴组件110内的超声传输波导联接到超声换能器/发生器组件104的超声换能器130(图2)部分。超声刀116和超声传输波导可由适用于传输超声能量的材料形成为单元构造。此类材料的例子包括Ti6Al4V(含有铝和钒的钛合金)、铝、不锈钢或其它合适的材料。或者,超声刀116可与超声传输波导管分开(并且具有不同的组成),并且通过例如螺柱、焊接、胶水、快速连接或其它合适的已知方法联接。超声传输波导管的长度可为例如半波长的整数倍(nλ/2)。超声传输波导可优选由实心轴制成,该实心轴由适合有效地传播超声能量的材料(诸如,上述钛合金(即Ti6Al4V)或任何适合的铝合金,或其它合金)或其它材料(诸如,蓝宝石)构造而成。
超声换能器/发生器组件104还包括用于驱动超声换能器130的电子电路。超声刀116可以合适的振动频率范围操作,该振动频率范围可为约20Hz至120kHz,最适合的振动频率范围可为约30kHz至100kHz。合适的操作振动频率可为例如大约55.5kHz。通过致动开关120对超声换能器130通电。
应当理解,本文相对于握持柄部组件102的临床医生使用术语“近侧”和“远侧”。因此,超声刀116相对于柄部组件102位于远侧,该柄部组件位于更近侧。还应当理解,为方便和清晰起见,本文相对于握持柄部组件102的临床医生使用空间术语诸如“顶部”和“底部”。然而,外科器械能够在许多取向和位置中使用,并且这些术语并非旨在为限制性的和绝对的。
图3为根据本公开的方面的图1所示外科器械100的模块化轴组件110的分解图。外科器械100使用超声振动对活组织进行外科治疗。轴组件110通过在柄部组件102上形成的狭槽142a、142b和在轴组件110上形成的突片134a、134b联接到柄部组件102。柄部组件102包括凸形联接构件136,其被接收在轴组件110中的相应凹形联接构件138中。凸形联接构件136可操作地联接到触发器108,使得当触发器108被挤压时,凸形联接构件136向远侧平移以驱动闭合管机构140,该闭合管机构使轴组件110的外管部分平移以闭合钳口构件114。如前所述,当触发器108被释放时,钳口构件114打开。凸形联接构件136还联接到位于轴组件110的外管144内的超声传输波导145(图2),并且联接到被接收在柄部组件102的喷嘴146内的超声换能器130(图2)。轴组件110经由电接触件137电联接到柄部组件102。
图4为根据本公开的方面的图1所示外科器械100的超声换能器/发生器组件104的透视透明图。图5为超声换能器/发生器组件104的端视图;图6为超声换能器/发生器组件104的透视图,其中顶部外壳部分被移除以暴露超声发生器162;图7为超声换能器/发生器组件104的剖视图。现在参考图4至图7,超声换能器/发生器组件104包括超声换能器130、用于驱动超声换能器130的超声发生器162,以及外壳148。第一电连接器158将超声发生器162联接到电池组件106(图1和图2),第二电连接器161将超声发生器162联接到喷嘴(图3)。在一个方面,显示器176可设置在超声换能器/发生器组件104外壳148的一侧上。
超声发生器162包括超声驱动器电路诸如图11所示的电路177,并且在一些方面包括第二级放大器电路178。电路177被构造用于驱动超声换能器130并且形成超声发生器电路的一部分。电路177包括变压器166和阻塞电容器168等部件。变压器166电联接到超声换能器130的压电元件150a、150b、150c、150d。电路177经由第一缆线179电联接到第一电连接器158。第一电连接器158电联接到电池组件106(图1和图2)。电路177经由第二缆线183电联接到第二电连接器160。第二电连接器160电联接到喷嘴146(图3)。在一个方面,第二级放大器电路178可用于两级放大系统中。
超声换能器130(被称为“Langevin叠堆件”)通常包括换能部分(包括压电元件150a-150d)、第一谐振器部分或端罩164、第二谐振器部分或前罩152以及辅助部件。这些部件的总体构造为谐振器。还可使用其它形式的换能器,诸如磁致伸缩换能器。超声换能器130的长度优选地为二分之一系统波长的整数倍(nλ/2;其中“n”为任何正整数;例如,n=1、2、3…),对此下文中将更详细地描述。声学组件包括端罩164、超声换能器130、前罩152和速度变换器154。
端罩164的远侧端部声学地联接到压电元件150a的近侧端部,前罩152的近侧端部声学地联接到压电元件150d的远侧端部。前罩152和端罩164的长度由多个变量确定,这些变量包括换能部分的厚度、用于制造端罩164和前罩152的材料的密度和弹性模量以及超声换能器130的谐振频率。前罩152可从其近侧端部到其远侧端部向内渐缩以在速度变换器154处放大超声振动振幅,或者其可不具有放大作用。合适的振动频率范围可为约20Hz至120kHz,最适合的振动频率范围可为约30kHz至100kHz。合适的操作振动频率可为例如大约55.5kHz。
超声换能器130包括声学地联接或堆叠以形成换能部分的多个压电元件150a-150d。压电元件150a-150d可由任何合适的材料诸如锆钛酸铅、偏铌酸铅、钛酸铅、钛酸钡或其它压电陶瓷材料制成。导电元件170a、170b、170c、170d插在压电元件150a-150d之间,以将电路177电联接到压电元件150a-150d。位于压电元件150a、150b之间的导电元件170d和位于压电元件150d和前罩152之间的导电元件170d电联接到电路177的正电极174a。位于压电元件150b、150c之间的导电元件170b和位于压电元件150c、150d之间的导电元件170c电联接到电路177的负电极174b。正电极174a和负电极174b通过电导体电联接到电路177。
超声换能器130将来自电路177的电驱动信号转换成机械能,该机械能主要产生超声换能器130和超声刀116(图1和图3)以超声频率纵向振动运动的声学驻波。在另一方面,超声换能器130的振动运动可在不同方向上起作用。例如,振动运动可包括更复杂的超声刀116运动的局部纵向分量。当对声学组件通电时,以由各种电参数和几何参数确定的谐振和振幅通过超声换能器130产生到超声刀116的驻波形式的振动运动。沿声学组件的任何点处的振动运动的振幅取决于沿声学组件测量振动运动的位置。振动运动驻波中的最小或零交点通常称为波节(即运动最小的位置),驻波中的局部最大绝对值或峰值通常称为波腹(即局部运动最大的位置)。波腹与距其最近的节点之间的距离为四分之一波长(λ/4)。
线将电驱动信号从电路177传输到正电极170a和负电极170b。响应于致动器诸如开关120通过从电路177供应的电信号对压电元件150a-150d通电,例如以在声学组件中产生声学驻波。电信号在压电元件150a-150d中引起反复小位移形式的扰动,使材料内出现较大的交替压缩力和张力。反复小位移使压电元件150a-150d以连续方式沿电压梯度的轴线膨胀和收缩,从而产生超声能量的纵向波。经由穿过轴组件110(图1至图3)的传输部件或超声传输波导将超声能量通过声学组件传输到超声刀116片(图1和图3)。
为了使声学组件将能量递送到超声刀116(图1和图3),声学组件的部件声学地联接到超声刀116。超声换能器130的联接螺柱156通过螺纹连接件诸如螺柱声学地联接到超声传输波导145。在一个方面,超声换能器130可声学地联接到超声传输波导145,如图10A和图10B所示。
优选对声学组件的部件进行声学调谐,使得任何组件的长度均为半波长(nλ/2)的整数倍,其中波长λ为声学组件的预选或操作纵向振动驱动频率fd的波长。还设想了声波组件可结合任何合适的声波元件布置。
超声刀116(图1和图3)的长度可为系统半波长(nλ/2)的整数倍。超声刀116的远侧端部可设置在波腹附近,以便提供远侧端部的最大纵向偏移。当对超声换能器130通电时,超声刀116的远侧端部可被构造成能够以例如55kHz的预定振动频率,在例如大约10至500微米峰到峰的范围内、优选在约30至150微米的范围内移动,并且在一些方面更接近100微米。
图8为根据本公开的一个方面的超声换能器/发生器组件104的正视图,该超声换能器/发生器组件被构造成能够以31kHz的谐振频率操作。图9为根据本公开的一个方面的超声换能器/发生器组件104’的正视图,该超声换能器/发生器组件被构造成能够以55kHz的谐振频率操作。可以看出,超声换能器/发生器组件104、104'、外壳148具有相同的尺寸,以便装配到图3所示的外科器械100的喷嘴146中。然而,各个超声换能器130、130'的尺寸将根据所需的谐振频率而变化。例如,以31kHz的谐振频率调谐的图8所示超声换能器130在外形上大于以55kHz的谐振频率调谐的图9所示超声换能器130’。超声换能器130、130'的联接螺柱156、156'可通过螺纹连接件诸如螺柱声学地联接到超声传输波导145。
图10A和图10B示出了根据本公开的一个方面的移位组件200,该移位组件相对于超声换能器130选择性地旋转超声传输波导145并且将它们朝向彼此推动。图10A示出了超声传输波导145和超声换能器130处于脱离构造的移位组件200,图10B示出了超声传输波导145和超声换能器130处于接合构造的移位组件200。现在参考图10A和图10B,移位组件200位于外科器械100的柄部组件102中。一个或多个套管204将超声换能器130保持在外壳148内的适当位置。超声换能器130的远侧端部包括由蜗轮206接合的螺纹202。当蜗轮206旋转时,超声换能器130在箭头208所示的方向上被推动,以将螺纹联接螺柱156拧入超声传输波导145的螺纹端中。蜗轮206可由位于外科器械100的柄部组件102内的马达驱动。
在一个方面,移位组件200可包括超声传输波导145的扭矩受限的马达驱动的附件,该附件经由位于柄部组件102中的马达驱动并且控制夹持、旋转和关节运动的轴致动。柄部组件102中的移位组件200以预定的最小扭矩将适当的扭矩施加到超声传输波导145上的适当位置。例如,柄部组件102可包括换能器扭转机构,该换能器扭转机构使主电机纵向移位,从而解联接主驱动轴正齿轮并且联接换能器扭转齿轮,该换能器扭转齿轮使轴和喷嘴旋转,从而将波导拧入换能器中。
图11为根据本公开的一个方面的适用于驱动超声换能器130的图4所示电路177的一个方面的示意图。电路177包括模拟多路复用器180。模拟多路复用器180多路复用来自上游信道SCL-A/SDA-A诸如超声波、电池和功率控制电路的各种信号。电流传感器182与功率源电路的返回引脚或接地引脚串联联接,以测量由功率源提供的电流。场效应晶体管(FET)温度传感器184提供环境温度。如果主程序忽略周期性地为脉宽调制(PWM)看门狗定时器188服务,则该看门狗定时器自动生成系统复位。当电路177由于软件或硬件故障而暂停或冻结时,使得该电路自动复位。应当理解,电路177可被构造为RF驱动电路,用于驱动超声换能器130或用于驱动RF电极,诸如图34所示的电路702。因此,现在重新参考图11,电路177可用于可互换地驱动超声换能器和RF电极。如果同时驱动,则可在相应的第一级电路5504中提供滤波器电路,以选择超声波形或RF波形。此类滤波技术在名称为“TECHNIQUES FORCIRCUIT TOPOLOGIES FOR COMBINED GENERATOR”的共同拥有美国专利申请号15/265,293中描述,该专利申请以引用方式全文并入本文。
驱动电路186提供左右超声能量输出端。表示信号波形的数字信号从控制电路诸如控制电路210(图14)提供给模拟多路复用器180的SCL-A/SDA-A输入。数模转换器190(DAC)将数字输入转换成模拟输出,以驱动联接到振荡器194的PWM电路192。PWM电路192向联接到第一晶体管输出级198a的第一栅极驱动电路196a提供第一信号,以驱动第一超声(左)能量输出端。PWM电路192还向联接到第二晶体管输出级198b的第二栅极驱动电路196b提供第二信号,以驱动第二超声(右)能量输出端。电压传感器199联接在超声左/右输出端子之间,以测量输出电压。驱动电路186、第一驱动电路196a和第二驱动电路196b以及第一晶体管输出级198a和第二晶体管输出级198b限定第一级放大器电路。在操作中,控制电路210(图14)产生采用电路诸如直接数字合成(DDS)电路1500、1600(图65和图66)的数字波形1800(图67)。DAC 190接收数字波形1800并将其转换成模拟波形,该模拟波形由第一级放大器电路接收和放大。
图12为根据本公开的一个方面的联接到图11所示电路177的变压器166的示意图。变压器166的超声左/右输入端子(主绕组)电联接到电路177的超声左/右输出端子。变压器166的次绕组联接到正电极174a和负电极174b。变压器166的正电极174a和负电极174b联接到超声换能器130(图4)的正端子170a(叠堆1)和负端子170b(叠堆2)。在一个方面,变压器166的匝数比n1:n2为1:50。
图13为根据本公开的一个方面的联接到测试电路165的图12所示变压器166的示意图。测试电路165联接到正电极174a和负电极174b。开关167与模拟超声换能器的负载的电感器/电容器/电阻器(LCR)负载串联放置。
图14为根据本公开的一个方面的控制电路210的示意图。控制电路210位于电池组件106的外壳内。电池组件106是各种本地功率源215的能量源。控制电路包括主处理器214,该主处理器经由接口主设备218通过例如输出SCL-A/SDA-A、SCL-B/SDA-B、SCL-C/SDA-C联接到各种下游电路。在一个方面,接口主设备218是通用串行接口,诸如I2C串行接口。主处理器214还被构造成能够通过通用输入输出220(GPIO)、显示器226(例如,LCD显示器)驱动开关224,并且通过GPIO 222驱动各种指示器228。提供看门狗处理器216以控制主处理器214。开关230与电池211串联设置,以在将电池组件106插入柄部组件102(图1至图3)时激活控制电路212。
在一个方面,主处理器214通过输出端子SCL-A/SDA-A联接到电路177(图4和图11)。主处理器214包括用于存储数字化驱动信号或波形的表的存储器,该数字化驱动信号或波形被传输到电路177以例如驱动超声换能器130(图4至图8)。在其它方面,主处理器214可生成数字波形并将其传输到电路177,或者可存储数字波形以便稍后传输到电路177。主处理器214还可通过输出端子SCL-B/SDA-B提供RF驱动,并且通过输出端子SCL-C/SDA-C提供各种传感器(例如,霍尔效应传感器、磁流变液(MRF)传感器等)。在一个方面,主处理器214被构造成能够感测超声驱动电路和/或RF驱动电路的存在,以实现适当的软件和用户界面功能。
在一个方面,主处理器214可为例如可购自Texas Instruments的LM4F230H5QR。在至少一个示例中,Texas Instruments LM4F230H5QR是ARM Cortex-M4F处理器内核,其包括高达40MHz的256KB单周期闪速存储器或其它非易失性存储器的芯片上存储器、40MHz以上的用于提高性能的预取缓冲区、32KB单周期串行随机存取存储器(SRAM)、加载有
Figure BDA0001767737420000221
软件的内置只读存储器(ROM)、2KB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(QED)模拟、一个或多个具有12个模拟输入通道的12位模数转换器(ADC),以及可用于产品数据表的易得的其它特征结构。可以很方便地换用其它处理器,因此,本公开不应限于这一上下文。
图15示出了根据本公开的一个方面的简化电路框图,其示出了包含在模块化超声外科器械334内的另一电路300。电路300包括处理器302、时钟330、存储器326、功率源304(例如,电池)、开关306(诸如,金属氧化物半导体场效应晶体管(MOSFET)功率开关)、驱动电路308(PLL)、变压器310、信号平滑电路312(也称为匹配电路,并且可为例如储能电路)、感测电路314、换能器130和轴组件110,该轴组件包括终止于超声刀116处的超声传输波导(本文可简称为波导)。
切断对高压(120VAC)输入功率(一般超声切割装置的特征)的依赖性的本公开的一个特征是,在整个波形成过程中利用低压切换并且仅直接在变压器级之前放大驱动信号。为此,在本公开的一个方面,功率仅来源于小到足以装配在柄部组件102内(图1至图3)的电池或一组电池。最先进的电池技术可提供高度和宽度为几厘米、深度为几毫米的强力电池。通过组合本公开的特征以提供自包含且自供电的超声装置,可降低制造成本。
功率源304的输出被送到处理器302并为其供电。处理器302接收并输出信号,并且如下所述,根据定制逻辑或根据由处理器302执行的计算机程序起作用。电路300还可包括存储器326,优选包括存储计算机可读指令和数据的随机存取存储器(RAM)。
功率源304的输出还被引导到具有由处理器302控制的占空比的开关306。通过控制开关306的接通时间,处理器302能够指示最终递送到换能器316的功率总量。在一个方面,开关306是MOSFET,但是其它开关和切换构造也是适合的。开关306的输出被送到驱动电路308,该驱动电路包含例如相位检测锁相环路(PLL)和/或低通滤波器和/或压控振荡器。通过处理器302对开关306的输出进行采样,以确定输出信号的电压和电流(分别为V入和I入)。这些值用于反馈架构中来调节开关306的脉宽调制。例如,开关306的占空比可从约20%变化到约80%,具体取决于来自开关306的期望输出和实际输出。
接收来自开关306的信号的驱动电路308包括振荡电路,该振荡电路将开关306的输出转换成具有超声频率(例如,55kHz(VCO))的电信号。如上所述,该超声波形的平滑型式最终被送到超声换能器130,以沿超声传输波导145(图2)产生谐振正弦波。
驱动电路308的输出端是变压器310,其能够将低压信号升高到更高电压。应当注意,变压器310之前的上游切换是在低(例如,电池驱动的)电压下执行的,迄今为止,这对于超声切割和烧灼装置来说是不可能的。这至少部分是由于装置有利地使用低导通电阻MOSFET切换装置这一事实。低导通电阻MOSFET开关是有利的,因为它们比传统MOSFET装置产生更低的切换损耗和更少的热量,并且允许更高的电流通过。因此,开关级(预变压器)可被表征为低电压/高电流。为了确保放大器MOSFET的导通电阻较低,MOSFET可例如在10V下运行。在此类情况下,可使用单独的10VDC功率源来为MOSFET栅极供电,这可确保MOSFET完全导通并且实现相当低的导通电阻。在本公开的一个方面,变压器310将电池电压升高到120V均方根(RMS)。变压器在本领域中是已知的,因此这里不再详细解释。
在所述的电路构造中,电路部件退化会对电路的电路性能产生负面影响。直接影响部件性能的一个因素是热量。已知电路通常监测切换温度(例如,MOSFET温度)。然而,由于MOSFET设计的技术进步以及相应的尺寸减小,MOSFET温度不再是电路负载和热量的有效指标。为此,根据本公开的一个方面,感测电路314感测变压器310的温度。该温度感测是有利的,因为变压器310在装置的使用期间在其最高温度下或非常接近其最高温度下运行。额外的温度将导致芯材料(例如,铁氧体)破裂并且可能发生永久性损坏。本公开可通过例如降低变压器310中的驱动功率、发信号通知用户、关闭电源、脉冲电源或其它适当的响应来对变压器310的最高温度作出响应。
在本公开的一个方面,处理器302通信地联接到端部执行器112,该端部执行器用于将材料放置成与超声刀116(例如,图1所示的夹持机构)物理接触。提供了传感器,其在端部执行器112处测量夹持力值(存在于已知范围内),并且基于所接收的夹持力值,处理器302改变运动电压VM。因为高力值与设定的运动速率相结合可导致刀温度较高,因此温度传感器336可通信地联接到处理器302,其中处理器302可操作以接收和解释来自温度传感器336的指示叶片的当前温度的信号,并且基于所接收的温度确定叶片运动的目标频率。在另一方面,力传感器诸如应变仪或压力传感器可联接到触发器108,以测量用户施加到触发器108的力。在另一方面,力传感器诸如应变仪或压力传感器可联接到开关120按钮,使得位移强度对应于用户施加到开关120按钮的力。
根据本公开的一个方面,驱动电路308的PLL部分(其联接到处理器302)能够确定波导运动的频率并将该频率通信到处理器302。当装置关闭时,处理器302将该频率值存储在存储器326中。通过读取时钟330,处理器302能够确定装置关闭后经过的时间,并且在经过的时间小于预定值的情况下检索波导运动的最后频率。然后,装置可在该最后频率下启动,该频率可能是当前负载的最佳频率。
图16示出了根据本公开的一个方面的与外科器械100一起使用的电池组件400。电池组件400包括外壳402,该外壳的尺寸和构造被设置成容纳各种能量电池。能量电池可包括可充电电池和不可充电电池。在一个方面,电池组件400包括四个锂离子不可充电电池404a、404b、404c、404d和两个镍金属氢化物(NiMH)可充电电池406a(第二电池未示出)。外壳402包括突片408a、408b,以将电池组件400可移除地连接到外科器械100的柄部组件102(图1和图2)。
图17示出了根据本公开的一个方面的与外科器械100一起使用的一次性电池组件410。在一个方面,一次性电池组件410包括用于与电池供电的高级能量器械诸如外科器械100(图1和图2)一起使用的一次电池组,该一次电池组包括利用附加电压补偿电子器件,以抵消一次性电池组件410的电压下降,从而防止输出电压在负载下的操作期间下降到预定水平以下。一次性电池组件410包括外壳412,该外壳的尺寸和构造被设置成容纳各种能量电池。能量电池可包括可充电电池和不可充电电池。在一个方面,一次性电池组件410包括四个一次锂离子(Li离子)不可充电电池414a、414b、414c、414d和两个二次NiMH或镍镉(NiCd)可充电电池416a、416b。外壳412包括电接触件418,以将一次性电池组件410电联接到外科器械100的柄部组件102。在所示的示例中,电接触件418包括四个金属接触件。一次性电池组件410还包括电路419,诸如控制电路210(图14)和/或电路300(图15)。电路419被辐射硬化。
在一个方面,一次性电池组件410包括电池414a-d、电路419和能够抗γ或其它辐射灭菌的其它部件。例如,切换模式功率源460(图22)或线性功率源470(图24)和任选的充电电路可结合在一次性电池组件410的外壳412内,以减小一次Li离子电池414a-d的电压下降并且允许使用二次NiMH电池416a、416b来减小电压下降。这保证了在每次手术开始时充满电的电池容易引入无菌区。包括一次锂离子电池414a-d和二次NiMH电池416a-b的双型电池组件可与专用能量电池416a-b一起使用,以控制来自使发生器和马达控制电路运行的专用能量电池414a-d的电子器件。在一个方面,在涉及的电池电量低的情况下,系统从驱动电子电路所涉及的电池中拉出。在一个方面,系统将包括单向二极管系统,该单向二极管系统将不允许电流沿相反方向流动,例如从驱动能量和/或马达控制电路所涉及的电池流动到驱动电子电路所涉及的电池。在一个附加方面,系统可包括伽马友好充电电路以及使用二极管和真空管部件的开关模式功率源,该功率源将电压下降最小化在预定水平。可通过包括作为NiMH电压(例如,三个NiMH电池)的分压的最小下降电压来省去开关模式功率源。在另一方面,可制造模块化系统,其中辐射硬化的部件位于模块中,使得该模块可通过辐射灭菌来灭菌。其它非辐射硬化的部件包括在其它模块化部件中,并且在模块化部件之间进行连接,使得部件一起操作,就像部件一起位于同一电路板上一样。如果仅需要二次NiMH电池416a-b中的两个电池,则基于二极管和真空管的开关模式功率源允许可灭菌电子器件在一次性一次锂离子电池414a-d内。
图18示出了根据本公开的一个方面的与外科器械100一起使用的可重复使用电池组件420。可重复使用电池组件420包括外壳422,该外壳的尺寸和构造被设置成容纳各种可充电能量电池。能量电池可包括可充电电池。在一个方面,可重复使用电池组件420包括五个层压的NiMH可充电电池424a、424b、424c、424d、424e。外壳422包括电接触件428,以将可重复使用电池组件420电联接到外科器械100的柄部组件102(图1和图2)。在所示的示例中,电接触件428包括六个金属接触件。可重复使用电池组件420还包括多达六个电路板429a、429b、429c、429d、429e、429f,这些电路板可包括电路诸如控制电路210(图14)和/或电路300(图15)。在一个方面,可重复使用电池组件420包括驱动FET晶体管和外壳422中的相关电路429a-f,以便轻松切换并且不需要关闭外科器械100(图1和图2)就能利用能量递送更换可重复使用电池组件420。
可重复使用电池组件420包括电池测试开关426和多达三个LED指示器427a、427b、427c,以确定可重复使用电池组件420中电池424a-e的健康状况。第一LED指示器427a可指示即可使用的完全充电电池424a-e。第二LED指示器427b可指示电池需要再充电。第三LED指示器427c可指示电池不好并且需要处理。可重复使用电池组件420健康指示允许用户在插入和使用电池之前确定电池424a-e的具体健康和能力。例如,通过激活电池测试开关426来检查可充电二次电池的充电状态、下降电压、一次电池电压,该电池测试开关可在卸载状态下或者利用放置在系统上的预定电阻负载来测量它们。电压可具有至少一个但更优选三个阈值,以比较所得到的电压检查结果。在为第一指示器427a的情况下,电池424a-e指示它们是否适合使用。利用三个水平,可重复使用电池组件420可显示完全充电、最低充电和一些边缘但有限的充电状态。该电池424a-e健康监测器可用于一次性电池组件410(图17)或可重复使用电池组件420。在为一次性电池组件410的情况下,其为即用/损坏的指示器。在为可重复使用电池组件420的情况下,除了即用/不可用之外,其还可指示剩余寿命、再充电容量、甚至出现故障之前的年龄。
图19为根据本公开的方面的可移除电池组件430的立体透视图,其中壳体的两半被移除,暴露出联接到多个电路板的电池单元,所述多个电路板联接到多引线电池端子。此外,多于或少于三个电路板可以提供扩展或有限的功能。如图19所示,多个电路板432、434、436可以堆叠架构定位,该架构提供了许多优点。例如,由于布局尺寸较小,电路板在可移除电池组件430内具有减小的占地面积,从而使得电池更小。另外,在该构造中,可以容易地将电源板与数字板隔开,以防止源自电源板的任何噪声对数字板造成损害。而且,堆叠构造允许板之间存在直接连接特征,从而减少线的存在。此外,电路板可被构造为刚挠刚性电路的一部分,以允许刚性部件被“扇形化”为更小的体积区域。
根据本公开的方面,电路板432、434、436提供了具体功能。例如,一个电路板432可提供用于执行电池保护电路的部件。类似地,另一电路板434可提供用于执行电池控制器的部件。另一电路板436可例如提供高功率降压控制器部件。最后,电池保护电路可提供用于联接电池单元438a-n的连接路径。通过将电路板放置在堆叠构造中并且按照它们各自的功能分隔这些电路板,可以最佳处理其各自的噪声和热量产生的特定顺序策略性地放置这些电路板。例如,具有高功率降压控制器部件的电路板产生的热量最多,因此可将其与其它板隔开并放置在叠堆的中心。这样,可使热量远离装置的外表面,以防止医师或装置的操作者感觉到热量。另外,电池板接地可以星形拓扑结构构型,其中心位于降压控制器板处,以减少接地回路产生的噪声。
策略性堆叠的电路板、从电路板到多引线电池端子组件的低导热率路径以及柔性电路3516是有助于防止热量到达装置的外表面的特征部。电池单元和降压部件热连接到柄部组件102(图1和图2)内的柔性电路,使得电池和降压部件产生的热量进入远离医师的手的部分。柔性电路具有相对高的热质量,这是由于其暴露面积宽阔并且铜具有有利的传导特性,铜在更宽阔的区域上重新引导、吸收和/或消散热量,从而减缓了装置外表面上的热量集中并限制了其上的高点温度。也可实施其它技术,包括但不限于更大的热井、热槽或绝缘体、装置的柔性电路或柄部组件102中的金属连接器帽和更重的铜含量。
当使用锂离子电池时,实现了可移除电池组件430的另一个优点。如前所述,锂离子电池不应以多个电池的并联构造充电。这是因为,随着特定电池中的电压增加,该电池开始比其它更低电压的电池更快地接受额外的电荷。因此,对电池进行监测,以便可单独控制对该电池的充电。当锂离子电池由一组电池438a-n形成时,需要从装置外部延伸到电池438a-n的多条线(每个电池单元除了具有第一条线外,还具有至少一条附加线)。通过具有可移除电池组件430,电池单元438a-n在一个方面可具有其自身的一组暴露接触件,并且当可移除电池组件430不存在于柄部组件102(图1和图2)内时,该组接触件可联接到外部非无菌电池充电装置中的一组相应接触件。在另一方面,电池单元438a-n可电连接到电池保护电路,以允许电池保护电路控制和调节电池438a-n的再充电。可移除电池组件430设置有电路,以防止可移除电池组件430的使用超过预期的寿命期限。该期限不仅由电池决定,而且还由外表面决定,包括电池壳件或壳体以及上部接触组件。将在下文进一步详细解释此类电路,并且该电路包括例如使用计数、再充电计数和距离制造的绝对时间计数。
图19还示出了多引线电池端子组件433,该组件是将可移除电池组件430内的部件电联接到柄部组件102(图1和图2)的电接口的接口。通过柄部组件102,可移除电池组件430能够与超声换能器/发生器组件104(图4)电联接(和机械联接)。如上所述,可移除电池组件430通过多引线电池端子组件433向外科器械100(图1和图2)以及本文所述的其它功能提供功率。多引线电池端子组件433包括多个接触垫435a-n,这些接触垫能够将可移除电池组件430内的端子单独地电连接到由柄部组件102的对接凹处提供的另一端子。此类电连接的一个示例联接到多个接触垫435a-n作为功率和通信信号路径。在多引线电池端子组件433方面,示出了十六个不同的接触垫435a-n。这一数目仅仅是例示性的。在一个方面,电池端子组件433的内侧具有在模制端子保持器上形成的井,该井可填充有灌封材料以形成气密密封。接触垫435a-n包覆模制在封盖中并且延伸穿过灌封井进入电池430的内部。这里可使用柔性电路来重新布置销阵列并且提供与电路板的电连接。在一个示例中,将4×4阵列转换成2×8阵列。在一个示例中,多引线电池端子组件433、多引线电池端子组件2804的多个接触垫435a-n包括相应的多个内部接触销437a-n。接触销437a提供了与相应的一个接触垫435a的直接电联接。
图20示出了根据本公开的一个方面的电池测试电路440。电池测试电路440包括如图18所述的电池测试开关426。电池测试开关426是接合LCR假负载的开关,该LCR假负载模拟换能器或轴组件电子器件。如图18所述,附加指示器电路可联接到电池测试电路440,以提供可重复使用电池组件420中电池容量的合适指示。所示的电池测试电路440可用于分别结合图16至图19所述的电池组件400、410、420、430中的任一者中。
图21示出了根据本公开的一个方面的用以维持最小输出电压的补充功率源电路450。补充功率源电路450可包括在结合图16至图19所述的电池组件400、410、420、430中的任一者中。补充功率源电路450防止输出电压Vo在高负载条件下下降。补充功率源电路450包括一组四个一次电池452a-b、452c-d(可使用多达n个电池),当在将电池组件400、410、420、430插入外科器械100的柄部组件102(图1和2)中时闭合开关453,这些一次电池被激活。一次电池452a-d可为锂离子电池,诸如CR123A锂离子电池。在负载下,一次电池452a-d提供输出电压Vo,而二次可充电电池454由电池充电器455充电。在一个方面,二次可充电电池454是NiMH电池并且电池充电器455是合适的NiMH充电器。当输出电压Vo由于高负载条件而下降或下垂时,电压Vx操作开关模式功率源456,以通过将额外电流供应到负载中来恢复输出电压Vo。提供二极管458以防止电流流入开关模式功率源456的输出端。因此,在补充电流可流入负载之前,开关模式功率源456的输出电压Vb必须超过二极管458两端的电压降(约0.7V)。任选地,可提供电池测试开关459和测试电阻器R测试以在负载条件下测试补充功率源电路450。具体地讲,根据图21,电池组件400、410、420、430可包括测试电路457a,该测试电路包括开关457b和电阻器457c,使得当闭合开关457b(例如,经由测试按钮426)时,电阻器457c测试一次电池452a-d是否能够递送输出电压Vo。否则,电阻器457测试二次电池454是否能够经由操作开关模式功率源456来递送Vb,使得通过二极管458的补充电流恢复输出电压Vo
图22示出了根据本公开的一个方面的用于向外科器械100供应能量的开关模式功率源电路460。开关模式功率源电路460可设置在分别结合图16、图17和图19所述的电池组件400、410、430中的任一者内。在所示的示例中,开关模式功率源电路460包括一次Li单元电池429a-d,其中正(+)输出电压联接到切换调节器464的输入端子V。应当理解,可使用任何合适数目的一次电池。开关模式功率源电路460包括远程接通/断开开关。切换调节器464的输入端V还包括由电容器Ci表示的输入滤波器。切换调节器464的输出端V联接到电感器L和由电容器Co表示的输出滤波器。钳位二极管D设置在V与地面之间。反馈信号被从输出滤波器Co提供给切换调节器464的FB输入端。负载电阻器RL表示负载。在一个方面,最小负载约为200mA。在一个方面,输出电压V在800mA下为3.3VDC。
图23示出了根据本公开的一个方面的用于向外科器械供应能量100的图22所示切换调节器464的分立型式。切换调节器464在V端子处从电池组件400、410、420、430接收输入电压。接通/断开输入端处的信号通过控制开关471的状态来启用或禁用切换调节器464的操作。在FB输入端处从负载接收反馈信号,在FB输入端处由分压器电路463分压。来自分压器463的电压被施加到固定增益放大器465的正输入端。固定增益放大器465的负输入端联接到带隙参考二极管469(例如,1.23V)。固定增益放大器465的放大输出被施加到比较器466的正输入端。比较器466的负输入端接收50kHz振荡器467输入。比较器466的输出被施加到驱动器468,该驱动器驱动并输出晶体管461。输出晶体管461经由V端子向负载供应电压和电流。
图24示出了根据本公开的一个方面的用于向外科器械100供应能量的线性功率源电路470。线性功率源电路470可设置在分别结合图16、图17、图18和图19所述的电池组件400、410、420、430中的任一者内。在所示的示例中,线性功率源电路470包括一次锂离子单元电池462a-d,其中正(+)输出电压联接到晶体管472的V端子。晶体管472的输出经由线性功率源电路470的V端子向负载供应电流和电压。输入滤波器Ci设置在输入侧,而输出滤波器Co设置在输出侧。齐纳二极管DZ将经调节的电压施加到晶体管472的基极。偏置电阻器将齐纳二极管DZ和晶体管472偏置。
图25为根据本公开的一个方面的模块化手持式超声外科器械480的正面分解图,其示出了左半壳从柄部组件482被移除,暴露出通信地联接到多引线柄部端子组件的装置标识符。在本公开的另外方面,使用智能电池来为模块化手持式超声外科器械480供电。然而,智能电池不限于模块化手持式超声外科器械480,并且如将要解释的,智能电池可用于各种装置中,这些装置可具有或可不具有彼此不同的功率要求(例如,电流和电压)。根据本公开的一个方面,智能电池组件486有利地能够识别与其电联接的特定装置。其通过加密或未加密的识别方法来实现。例如,智能电池组件486可具有连接部分,诸如连接部分488。柄部组件482还可设置有装置标识符,该装置标识符可通信地联接到多引线柄部端子组件491并且可操作以通信关于柄部组件482的至少一条信息。该信息可涉及柄部组件482已被使用的次数、超声换能器/发生器组件484(当前与柄部组件482断开连接)已被使用的次数、波导轴组件490(当前连接到柄部组件482)已被使用的次数、当前连接到柄部组件482的波导轴组件490的类型、当前连接到柄部组件482的超声换能器/发生器组件484的类型或身份以及/或者许多其它特征。当将智能电池组件486插入柄部组件482中时,智能电池组件486内的连接部分488与柄部组件482的装置标识符进行通信接触。柄部组件482通过硬件、软件或其组合能够将信息传输到智能电池组件486(无论是通过自启动还是响应于来自智能电池组件486的请求)。该通信的标识符由智能电池组件486的连接部分488接收。在一个方面,一旦智能电池组件486接收到信息,通信部分便可操作以控制智能电池组件486的输出以符合装置的特定功率要求。
在一个方面,通信部分包括处理器493和存储器497,它们可为单独或单个部件。处理器493与存储器组合,能够为模块化手持式超声外科器械480提供智能功率管理。这一方面是特别有利的,因为超声装置诸如模块化手持式超声外科器械480具有对于模块化手持式超声外科器械480而言可为唯一的功率要求(频率、电流和电压)。事实上,模块化手持式超声外科器械480可对一个尺寸或类型的外管494具有特定的功率要求或限制,并且对具有不同尺寸、形状和/或构造的第二类型波导具有第二不同的功率要求。
因此,根据本公开的一个方面的智能电池组件486允许电池组件用于多种外科器械中。因为智能电池组件486能够识别其附接的装置并且能够相应地改变其输出,所以利用智能电池组件486的各种不同外科器械的操作者不再需要关注他们试图在正被使用的电子装置中安装哪个功率源。这在以下操作环境中是特别有利的:在复杂的外科规程中间需要用另一个外科器械替换或互换电池组件。
在本公开的另一方面,智能电池组件486将每次使用特定装置的记录存储在存储器497中。该记录可用于评估装置的有用寿命或许可寿命的结束。例如,一旦装置使用20次,连接到装置的智能电池组件486中的此类电池将拒绝向其供电,因为装置被定义为“不再可靠”的外科器械。可靠性基于许多因素确定。一个因素可为磨损,可通过多种方式估计磨损,包括装置已被使用或激活的次数。在使用一定次数之后,装置的部件可能会磨损,并且超过部件之间的公差。例如,智能电池组件486可感测由柄部组件482接收的按钮按压的次数,并且可确定何时达到或超过按钮按压的最大次数。智能电池组件486还可监测按钮机构的阻抗,该阻抗例如在柄部被污染(例如,被盐水污染)的情况下可改变。
该磨损会导致规程期间出现不可接受的故障。在一些方面,智能电池组件486可识别哪些部件在装置中组合在一起,甚至可识别部件经历的使用次数。例如,如果智能电池组件486是根据本公开的智能电池,则其可在用户尝试使用复合装置之前识别柄部组件482、波导轴组件490以及超声换能器/发生器组件484。智能电池组件486内的存储器497可例如记录超声换能器/发生器组件484被操作的时间,以及操作的方式、时间和持续时间。如果超声换能器/发生器组件484具有单独的标识符,则智能电池组件486可追踪超声换能器/发生器组件484的使用,并且一旦柄部组件482或超声换能器/发生器组件484超过其最大使用次数,拒绝向超声换能器/发生器组件484供电。超声换能器/发生器组件484、柄部组件482、波导轴组件490或其它部件还可包括记录该信息的存储器芯片。这样,智能电池组件486中任何数目的智能电池可与任何数目的超声换能器/发生器组件484、缝合器、脉管密封器等一起使用,并且仍然能够确定超声换能器/发生器组件484、缝合器、脉管密封器等的总使用次数或总使用时间(通过使用时钟)或总致动次数等,或者充电或放电周期。智能功能可位于电池组件486外部,并且可位于例如柄部组件482、超声换能器/发生器组件484和/或轴组件490中。
当对超声换能器/发生器组件484的使用进行计数时,为了智能地终止超声换能器/发生器组件484的寿命,外科器械准确地区分外科规程中超声换能器/发生器组件484的实际使用的完成和由于例如外科规程中的电池更换或暂时延迟而引起的超声换能器/发生器组件484的致动短时失效。因此,作为仅对超声换能器/发生器组件484的激活次数进行计数的替代方案,可实施实时时钟(RTC)电路来追踪超声换能器/发生器组件484实际关闭的时间量。根据所测量的时间长度,可通过适当的逻辑来确定关闭是否足够严重以被视为一次实际使用的结束,或者关闭时间是否太短而不被视为一次使用的结束。因此,在一些应用中,该方法可比仅“基于激活”的算法更准确地确定超声换能器/发生器组件484的使用寿命,“基于激活”的算法例如可提供在外科规程中发生十次“激活”,因此十次激活应指示计数器增加1。通常,该类型和内部计时系统将防止误用被设计为欺骗简单的“基于激活”的算法的设备,并且将防止在只有出于合理原因才需要将超声波换能器/发生器组件484或智能电池组件486简单解除配合的情况下错误地记录完整使用。
尽管外科器械480的超声换能器/发生器组件484是可重复使用的,但是在一个方面,可设置有限的使用次数,因为外科器械480在清洁和灭菌期间会经受严苛的条件。更具体地讲,电池组被构造成能够被灭菌。无论外表面采用何种材料,所用的实际材料的预期寿命都是有限的。该寿命由各种特征决定,这些特征可包括例如电池组实际已经灭菌的次数、距离电池组制造的时间以及电池组已经充电的次数等等。而且,电池单元本身的寿命是有限的。本公开的软件结合了本发明的算法,该算法可验证超声换能器/发生器组件484和智能电池组件486的使用次数,并且在达到或超过该使用次数时禁用该装置。可利用每种可能的灭菌方法来对电池组外部进行分析。基于最严苛的灭菌程序,可限定允许灭菌的最大次数,并且可将该次数存储在智能电池组件486的存储器中。如果假设充电器是非灭菌的并且智能电池组件486将在充电后被使用,则充电计数可被定义为等于该特定电池组遇到的灭菌次数。
在一个方面,电池组中的硬件可被禁用,以最小化或消除由于在通过软件禁用电池组之后从电池单元连续放电而引起的安全问题。在某些低电压条件下,电池的内部硬件无法禁用电池的情况可能存在。在此类情况下,在一个方面,充电器可用于“杀死”电池。由于电池在充电器中时电池微控制器处于关闭状态这一事实,可使用基于非易失性系统管理总线(SMB)的电可擦除可编程只读存储器(EEPROM)来在电池微控制器与充电器之间交换信息。因此,即使在电池微控制器关闭时,也可使用串行EEPROM来存储可写入和读取的信息,这在尝试与充电器或其它外围设备交换信息时是非常有用的。该示例性EEPROM可被构造成能够包含足够的存储器寄存器,以存储至少(a)电池应被禁用时的使用计数限制(电池使用计数)、(b)电池经历的程序次数(电池程序计数)和/或(c)电池经历的充电次数(充电计数)等等。存储在EEPROM(诸如,使用计数寄存器和充电计数寄存器)中的一些信息存储在EEPROM的写保护部分中,以防止用户更改信息。在一个方面,使用和计数器与相应的位反次要寄存器一起存储,以检测数据损坏。
SMBus线路中的任何残余电压都可能损坏微控制器并破坏SMBus信号。因此,为了确保在微控制器关闭时电池控制器703的SMBus线路不承载电压,在外部SMBus线路与电池微控制器板之间提供了继电器。
在对智能电池组件486充电期间,当采用恒流/恒压充电方案时,在例如流入电池的电流以逐渐减少的方式下降到给定阈值以下时,确定智能电池组件486内电池的“充电结束”状况。为了准确地检测该“充电结束”状况,电池微控制器和降压板在对电池充电期间断电并关闭,以减少可能由降压板引起的且可干扰逐渐减少的电流检测的任何电流损耗。另外,微控制器和降压板在充电期间断电,以防止任何由此导致的SMBus信号损坏。
关于充电器,在一个方面,防止智能电池组件486以任何方式插入充电器中除正确插入位置之外的位置。因此,智能电池组件486的外部设置有充电器保持特征部。用于将智能电池组件486牢固地保持在充电器中的杯件被构造有轮廓匹配的锥形几何形状,以防止智能电池组件486以除正确(预期)方式之外的任何方式意外插入。进一步设想了可由充电器本身检测智能电池组件486的存在。例如,充电器可被构造成能够检测来自电池保护电路的SMBus传输以及位于保护板中的电阻器的存在。在此类情况下,充电器将被启用以控制在充电器的引脚处暴露的电压,直到智能电池组件486正确安置或在充电器处就位。这是因为充电器的引脚处的暴露电压存在危险和风险:引脚两端可能发生电短路,并且电短路会导致充电器无意开始充电。
在一些方面,智能电池组件486可通过音频和/或视觉反馈与用户通信。例如,智能电池组件486可使LED以预设方式照亮。在此类情况下,即使超声换能器/发生器组件484中的微控制器控制LED,微控制器也直接从智能电池组件486接收要执行的指令。
在本公开的又一方面,超声换能器/发生器组件484中的微控制器在预定时间段内不使用时进入睡眠模式。有利地,当处于睡眠模式时,微控制器的时钟速度降低,从而显著地切断电流损耗。一些电流继续被消耗,因为处理器继续砰砰等待感测输入。有利地,当微控制器处于该省电睡眠模式时,微控制器和电池控制器可直接控制LED。例如,解码器电路可内置在超声换能器/发生器组件484中并且连接到通信线路,使得当超声换能器/发生器组件484微控制器“关闭”或处于“睡眠模式”时LED可由处理器493独立控制。该省电特征省去了唤醒超声换能器/发生器组件484中的微控制器的需要。通过允许关闭发生器同时仍然能够主动控制用户界面指示器,节省了功率。
另一方面使一个或多个微控制器减速,以在不使用时节省功率。例如,可降低两个微控制器的时钟频率,以节省功率。为了保持同步操作,微控制器协调它们各自的时钟频率变化(降低频率以及随后当需要全速操作时增加频率)几乎同时发生。例如,当进入空闲模式时,时钟频率降低,并且当退出空闲模式时,频率增加。
在另一方面,智能电池组件486能够确定其电池内剩余的可用功率量,并且如果确定剩余足够的电池功率量来在整个预期程序中可预测地操作装置,则该智能电池组件被编程为仅操作与其附接的外科器械。例如,如果电池内没有足够的功率来操作外科器械20秒,则智能电池组件486能够保持在非操作状态。根据一个方面,智能电池组件486确定在其最近的先前功能(例如,外科切割)结束时电池内剩余的功率量。因此,在这方面,如果例如在该程序期间,智能电池组件486确定电池不具有充足的功率,则该智能电池组件将不允许执行后续功能。或者,如果智能电池组件486确定有充足的功率用于后续程序并且在该程序期间低于该阈值,则其不会中断正在进行的程序,而是将允许其完成并且此后防止其它程序发生。
下文解释了利用本公开的智能电池组件486来最大化装置的使用的优点。在该示例中,一组不同的装置具有不同的超声传输波导。根据定义,波导可具有各自的最大允许功率限制,其中超过该功率限制会使波导过载并且最终导致其破裂。来自该组波导的一个波导自然将具有最小的最大功率容差。由于现有技术的电池缺乏智能电池功率管理,因此现有技术的电池的输出必须受到被设想为与装置/电池一起使用的该组中的最小/最薄/最脆弱波导的最小最大允许功率输入值的限制。这在即使较大较厚的波导稍后可附接到该柄部的情况下也适用,并且根据定义允许施加更大的力。该限制对于最大电池功率也适用。例如,如果一个电池被设计用于多个装置,则其最大输出功率将被限制为使用其的装置中任一个的最低最大额定功率。利用此类构造,一个或多个装置或装置构造将不能最大化电池的使用,因为电池不清楚特定装置的具体限制。
在一个方面,智能电池组件486可用于智能地避开上述超声装置限制。智能电池组件486可为一个装置或特定装置构造产生一个输出,并且同一智能电池组件486可稍后为第二装置或装置构造产生不同的输出。该通用智能电池外科系统非常适合空间和时间都非常宝贵的现代化手术室。通过使智能电池组操作许多不同的装置,护士可轻松地管理这些电池组的存储、检索和库存。有利地,在一个方面,根据本公开的智能电池系统可采用一种类型的充电站,从而增加了使用的便利性和效率并且降低了手术室充电设备的成本。
另外,其它外科器械诸如电动缝合器可具有与模块化手持式超声外科器械480不同的功率要求。根据本公开的各个方面,智能电池组件486可与一系列外科器械中的任何一个一起使用,并且可被制造成将其自身的功率输出定制为适于其所安装的特定装置。在一个方面,通过控制开关模式功率源的占空比(诸如,降压、降压-升压、升压)或者与智能电池组件486集成或以其它方式联接到该智能电池组件并由该智能电池组件控制的其它配置来执行该功率定制。在其它方面,智能电池组件486可在装置操作期间动态地改变其功率输出。例如,在脉管密封装置中,功率管理提供了改进的组织密封。在这些装置中,需要较大的恒定电流值。需要动态地调节总功率输出,因为在密封组织时,其阻抗会发生变化。本公开的方面为智能电池组件486提供了可变的最大电流限制。根据应用或装置的要求,该电流限制可因不同应用(或装置)而异。
图26为根据本公开的一个方面的图25所示超声外科器械480的触发器483部分和开关的详细视图。触发器483可操作地联接到端部执行器492的钳口构件495。在激活激活开关485时,通过超声换能器/发生器组件484对超声刀496通电。现在继续图25同时参见图26,触发器483和激活开关485被示出为柄部组件482的部件。触发器483激活端部执行器492,该端部执行器与波导轴组件490的超声刀496具有协作关联,以使端部执行器钳口构件495与超声刀496之间能够与组织和/或其它物质进行各种接触。端部执行器492的钳口构件495通常是枢转钳口,其用于抓持或夹持设置在钳口与超声刀496之间的组织上。在一个方面,当触发器被完全按下时,在触发器中提供发出咔嗒声的听觉反馈。通过触发器在闭合时所扣合的薄金属部件可产生噪声。该特征为用户反馈添加了听觉部件,其告知用户钳口完全压靠波导并且施加了足够的夹持压力来实现脉管密封。在另一方面,力传感器诸如应变仪或压力传感器可联接到触发器483,以测量用户施加到触发器483的力。在另一方面,力传感器诸如应变仪或压力传感器可联接到开关485按钮,使得位移强度对应于用户施加到开关485按钮的力。
当被按下时,激活开关485将模块化手持式超声外科器械480置于超声操作模式中,该模式在波导轴组件490处引起超声运动。在一个方面,按下激活开关485使得开关内的电接触件闭合,从而完成智能电池组件486与超声换能器/发生器组件484之间的电路,以便将电功率施加到超声换能器,如前所述。在另一方面,按下激活开关485可闭合到智能电池组件486的电接触件。当然,这里对闭合电路中的电接触件的描述仅仅是开关操作的示例性一般描述。有许多替代方面可包括断开接触件或处理器控制的功率递送,该处理器控制的功率递送从开关接收信息并且基于该信息指示相应的电路反应。
图27为根据本公开的一个方面的来自远侧端部的端部执行器492的局部放大透视图,其中钳口构件495处于打开位置。参考图27,示出了波导轴组件490的远侧端部498的透视局部图。波导轴组件490包括围绕波导的一部分的外管494。波导499的超声刀496部分从外管494的远侧端部498突出。超声刀496部分在医疗期间接触组织并且将其超声能量传递给组织。波导轴组件490还包括钳口构件495,该钳口构件联接到外管494和内管(在该视图中不可见)。钳口构件495与内管和外管以及波导499的超声刀496部分一起可称为端部执行器492。如将在下文所述,外管494和未示出的内管相对于彼此纵向滑动。当外管494与未示出的内管之间发生相对运动时,钳口构件495在枢转点上枢转,从而引起钳口构件495打开和闭合。当闭合时,钳口构件495在位于钳口构件495与超声刀496之间的组织上施加夹紧力,确保刀与组织积极有效地接触。
图28示出了根据本公开的一个方面的外科器械100的模块化轴组件110和端部执行器112部分。轴组件110包括外管144、内管147和超声传输波导145。轴组件110可移除地安装到柄部组件102。内管147可滑动地接收在外管144内。超声传输波导145定位在内管147内。端部执行器112的钳口构件114在枢转点151处可枢转地联接到外管144。钳口构件114还通过销153联接到内管147,使得当内管147在狭槽155内滑动时,钳口构件打开和闭合。在所示的构造中,内管147处于其远侧位置并且钳口构件114打开。为了闭合钳口构件114,内管147在近侧方向157上回缩,并且为了打开钳口构件,该内管在远侧方向159上推进。轴组件110的近侧端部包括钳口构件管(例如,内管)/弹簧组件141。提供了弹簧139以施加恒定的力控制机构来与以下不同轴组件一起使用:用于控制恒定力闭合的马达闭合件、用于驱动闭合系统的双杆机构、用于推拉闭合系统的凸轮凸角、用于驱动闭合的驱动螺杆设计或用于控制恒定力的波形弹簧设计。
图29为内管/弹簧组件141的详细视图。闭合机构149可操作地连接到触发器108(图1至图3)。因此,当触发器108被挤压时,内管143在近侧方向157上回缩,以闭合钳口构件114。因此,当触发器108被释放时,内管143在远侧方向159上推进,以打开钳口构件114。
对于组合超声/电外科器械的更详细描述,参考美国专利号9,107,690,其以引用方式并入本文。
图30示出了根据本公开的一个方面的模块化电池供电手持式组合超声/电外科器械500。图31为根据本公开的一个方面的图30所示外科器械500的分解图。现在参考图30和图31,外科器械500包括柄部组件502、超声换能器/RF发生器组件504、电池组件506、轴组件510和端部执行器512。超声换能器/RF发生器组件504、电池组件506和轴组件510是可移除地连接到柄部组件502的模块化部件。柄部组件502还包括马达组件560。外科器械500被构造成能够使用超声振动和电外科高频电流来对活组织进行外科凝固/切割治疗,并且使用高频电流来对活组织进行外科凝固治疗。可根据算法或用户输入控制独立地或组合地施加超声振动和高频(例如,RF)电流。
超声换能器/RF发生器组件504包括外壳548、显示器576(诸如,LCD显示器)、超声换能器530、电路177(图4、图10和/或图14中的电路300)和电路702(图34),该电路被构造成能够驱动RF电极并且形成RF发生器电路的一部分。轴组件510包括外管544、超声传输波导545和内管(未示出)。端部执行器512包括钳口构件514和超声刀516。钳口构件514包括联接到RF发生器电路的电极515。超声刀516是超声传输波导545的远侧端部。钳口构件514可枢转地旋转以抓持钳口构件514与超声刀516之间的组织。钳口构件514可操作地联接到触发器508。触发器508用于在触发器508被挤压时闭合钳口构件514,并且在触发器508被释放时打开钳口构件514以释放组织。在一级触发器构造中,触发器508被挤压以闭合钳口构件514,并且一旦钳口构件514闭合,开关部分的第一开关521a被激活以对RF发生器通电,从而密封组织。在密封组织之后,开关部分520的第二开关521b被激活以对超声发生器通电,从而切割组织。在各个方面,触发器508可为两级或多级触发器。在两级触发器构造中,在第一级期间,触发器508被挤压部分路程以闭合钳口构件514,并且在第二级期间,触发器508被挤压剩余路程以对RF发生器电路通电,从而密封组织。在密封组织之后,开关521a、521b中的一个可被激活以对超声发生器通电,从而切割组织。在切割组织之后,通过释放触发器508打开钳口构件514,从而释放组织。在另一方面,力传感器诸如应变仪或压力传感器可联接到触发器508,以测量用户施加到触发器508的力。在另一方面,力传感器诸如应变仪或压力传感器可联接到开关520按钮,使得位移强度对应于用户施加到开关520按钮的力。
电池组件506通过电连接器532电连接到柄部组件502。柄部组件502设置有开关部分520。第一开关520a和第二开关520b设置在开关部分520中。通过致动第一开关520a来激活RF发生器,并且通过致动第二开关520b来激活超声刀516。因此,第一开关520a对RF电路通电以驱动高频电流通过组织,从而形成密封,并且第二开关520b对超声换能器530通电以使超声刀516振动,从而切割组织。
旋钮518可操作地联接到轴组件510。使旋钮518在箭头526所示的方向上旋转±360°使得外管544在箭头528的相应方向上旋转±360°。在一个方面,另一个旋钮522可被构造成能够在超声刀516保持静止时使钳口构件514旋转,并且旋钮518使外管144旋转±360°。外管144可具有在例如5mm至10mm范围内的直径D1
图32为根据本公开的一个方面的模块化电池供电手持式组合超声/RF外科器械600的局部透视图。外科器械600被构造成能够使用超声振动和高频电流来对活组织进行外科凝固/切割治疗,并且使用高频电流来对活组织进行外科凝固治疗。可根据算法或用户输入控制独立地或组合地施加超声振动和高频(例如,RF)电流。外科器械600包括柄部组件602、超声换能器/RF发生器组件604、电池组件606、轴组件(未示出)和端部执行器(未示出)。超声换能器/RF发生器组件604、电池组件606和轴组件是可移除地连接到柄部组件602的模块化部件。触发器608可操作地联接到柄部组件602。如前所述,触发器操作端部执行器。
超声换能器/RF发生器组件604包括外壳648、显示器676(诸如,LCD显示器)。显示器676提供外科规程参数的视觉显示,诸如组织厚度、密封状态、切割状态、组织厚度、组织阻抗、正执行的算法、电池容量、正施加的能量(超声振动或RF电流)等参数。超声换能器/RF发生器组件604还包括两个视觉反馈指示器678、679,以指示当前在外科规程中施加的能量模态。例如,一个指示器678示出何时使用RF能量,而另一个指示器679示出何时使用超声能量。应当理解,当施加RF和超声能量模态两者时,两个指示器都将显示该状况。外科器械600还包括超声换能器、超声发生器电路和/或电路、轴组件以及包括钳口构件和超声刀的端部执行器,这些模块化部件类似于结合图30和图31所述的那些模块化部件,为了使公开内容简洁和清楚,这里将不再重复该描述。
电池组件606通过电连接器电连接到柄部组件602。柄部组件602设置有开关部分620。第一开关620a和第二开关620b设置在开关部分620中。通过致动第一开关620a来激活超声刀,并且通过致动第二开关620b来激活RF发生器。在另一方面,力传感器诸如应变仪或压力传感器可联接到触发器608,以测量用户施加到触发器608的力。在另一方面,力传感器诸如应变仪或压力传感器可联接到开关620按钮,使得位移强度对应于用户施加到开关620按钮的力。
旋钮618可操作地联接到轴组件。旋转旋钮618±360°使得外管在相应的方向上旋转±360°,如本文结合图30和图31所述。在一个方面,另一个旋钮可被构造成能够在超声刀保持固定时使钳口构件旋转,并且旋钮618使外管旋转±360°。按钮673用于将轴组件连接并保持到柄部组件602上。另一个滑动开关675用于锁定和释放超声换能器/RF发生器组件604。
在一个方面,外科器械500、600包括电池供电高级能量(超声振动加高频电流),其中驱动器放大被分成多级。放大的不同级可存在于外科器械500、600的不同模块化部件(诸如,柄部组件502、602;超声换能器/RF发生器组件504、604;电池组件506、606;轴组件510和/或端部执行器112)中。在一个方面,超声换能器/RF发生器组件504、604可包括外壳548、648内超声换能器和/或RF电子电路中的放大级,以及基于与特定能量模式相关联的能量模态的不同放大比率。可通过总线结构诸如I2C,经由来自外科器械100的位于柄部组件502、602和/或电池组件506、606中的电子系统的信号来控制末级,如前所述。末级开关系统可用于向变压器和阻塞电容器施加功率,以形成RF波形。RF输出诸如电压和电流的测量结果通过总线反馈到电子系统。柄部组件502、602和/或电池组件506、606可包含大部分主放大电路,包括任何电隔离部件、马达控件和波形发生器。两个不同的超声换能器(例如,图8和图9所示的超声换能器130、130')和RF换能器包含电子器件,以利用前置条件发生器信号并执行最终调节,从而以所需的频率范围和幅度为RF信号的不同频率换能器供电。这最小化了仅位于换能器本身中的电子器件的重量大小和成本。这还允许主处理器板占据柄部中具有稀有的最有用空间的区域,该区域由于其尺寸是换能器所在位置。这还允许电子器件被分开,使得高磨损高占空比元件可仅连接性附接到主电子器件,从而使其更易于维修和修理,因为系统被设计用于高度重复使用,然后才被处理。
结合图30至图32所述的外科器械500、600被构造成能够使用高频电流来对活组织进行外科凝固/切割治疗,并且使用高频电流来对活组织进行外科凝固治疗。因此,下文将结合图33至图44描述用以执行该附加功能的附加结构和功能部件。
电池组件506、606的结构和功能方面类似于结合图1、图2以及图16至图24所述的用于外科器械100的电池组件106的结构和功能方面,包括结合图20至图24所述的电池电路。因此,为了使公开内容简洁和清楚,电池组件106的此类结构和功能方面以引用方式并入本文,并且这里不再重复。类似地,除非另有说明,否则轴组件510的结构和功能方面类似于结合图1至图3所述的用于外科器械100的轴组件110的结构和功能方面。因此,为了使公开内容简洁和清楚,轴组件110的此类结构和功能方面以引用方式并入本文,并且这里不再重复。此外,超声换能器530发生器电路的结构和功能方面类似于结合图1、图2以及图4至图15所述的用于外科器械100的超声换能器130发生器电路的结构和功能方面。因此,为了使公开内容简洁和清楚,超声换能器130和发生器电路的此类结构和功能方面以引用方式并入本文,并且这里不再重复。此外,外科器械500、600包括结合图12至图15所述的电路,包括例如结合图14所述的控制电路210和结合图15所述的电路300。因此,为了使公开内容简洁和清楚,对结合图12至图15所述的电路的描述以引用方式并入本文,并且这里不再重复。
现在转向图33,示出了根据本公开的一个方面的结合图30至图32所述的外科器械500、600的喷嘴700部分。喷嘴700包含电路702,该电路被构造成能够将高频RF电流驱动到位于端部执行器中的电极,如下文结合图38至图44所述。电路702联接到变压器704的主绕组。变压器704的次绕组的正侧联接到串联连接的第一阻塞电容器706和第二阻塞电容器708。第二阻塞电容器708的负载侧联接到正RF(+)端子,该正RF(+)端子联接到端部执行器电极的正侧。变压器704的次绕组的负侧联接到负RF(-)端子(否则称为接地)。应当理解,RF能量电路的RF(-)或接地端子联接到外管744,该外管由导电金属形成。因此,在使用中,高频电流从端部执行器电极RF(+)通过组织传导,并且通过负电极RF(-)返回。
现在还参考图30、图31,在一个方面,外管744可操作地联接到端部执行器512的钳口构件514部分,使得当外管744在远侧方向722上推进时钳口构件514打开,并且当外管744在近侧方向724上回缩时钳口构件514闭合。尽管未在图33中示出,但是外管744可操作地联接到触发器508,该触发器用于打开和闭合端部执行器512的钳口构件514部分。用于与本文所述的超声外科器械一起使用的致动机构的示例在美国公布号2006/0079879和美国公布号2015/0164532中公开,以上公布各自以引用方式并入本文。
仍然参考图30、图31和图33,在一个方面,内管714可滑动地设置在外管744内。内管714可操作地联接到钳口构件514,以在保持超声刀516固定时使钳口构件514旋转。在图30和图31所示的方面,内管714由旋钮522旋转。在图33所示的方面,马达719可设置在柄部组件502内,以任选地通过空转齿轮725接合外管744的近侧端部上的齿轮721。
仍然参考图30、图31和图33,在一个方面,内部电绝缘(例如,橡胶、塑料)管716可滑动地设置在内管714内。柔性电路728可设置在内部电绝缘管716内,以将能量和传感器电路电联接到端部执行器512。例如,钳口构件514可包括联接到柔性电路728中的导体的电极。在其它方面,端部执行器512、钳口构件514或超声刀516可包括各种传感器或其它电元件,这些传感器和电元件可互连到例如轴组件510、柄部组件502、超声换能器/RF发生器组件504和/或电池组件506中的电路和部件。
仍然参考图30、图31和图33,在一个方面,超声传输波导545(为了清楚起见,仅在图32中示出,未在图33中示出)设置在内部电绝缘管716内。在一个方面,电路702的正电极RF(+)电联接到超声传输波导545,并且电路702的负电极RF(-)电联接到电联接到外管744的设置在钳口构件514中的电极。在操作中,在将组织抓持在超声刀516与钳口构件514之间之后,外科器械500的控制电路可执行各种算法以密封和切割组织。可根据所监测的组织条件(诸如,组织阻抗、摩擦等)将超声振动和高频能量施加到组织。在一些情况下,高频电流通过超声刀516施加到组织,并且返回到外管744返回路径。监测组织阻抗,并且当形成组织密封(如通过组织阻抗确定)时,机械地对超声刀516通电以将振动能量引入组织,从而切割组织。在其它方面,可通过脉动这些能量模态、交替或同时施加能量模态来施加超声振动和高频。在某些独特的情况下,算法可检测何时组织阻抗极低而不能向组织递送能量。作为响应,算法机械地对超声刀516通电以向组织施加振动能量,直到阻抗上升到适用于施加高频电流的阈值以上。在达到该阈值时,算法将能量递送模式切换为高频电流以密封组织。
图34为根据本公开的一个方面的被构造成能够驱动高频电流(RF)的电路702的一个方面的示意图。电路702包括模拟多路复用器580。模拟多路复用器580多路复用来自上游信道SCL-A/SDA-A诸如RF、电池和功率控制电路的各种信号。电流传感器582与功率源电路的返回引脚或接地引脚串联联接,以测量由功率源提供的电流。场效应晶体管(FET)温度传感器584提供环境温度。如果主程序忽略周期性地为脉宽调制(PWM)看门狗定时器588服务,则该看门狗定时器自动生成系统复位。当电路702由于软件或硬件故障而暂停或冻结时,使得该电路自动复位。应当理解,电路702可被构造用于驱动RF电极或用于驱动超声换能器130,如结合例如图11所述。因此,现在重新参考图34,电路702可用于可互换地驱动超声和RF电极。
驱动电路586提供左右RF能量输出端。表示信号波形的数字信号从控制电路诸如控制电路210(图14)提供给模拟多路复用器580的SCL-A/SDA-A输入。数模转换器590(DAC)将数字输入转换成模拟输出,以驱动联接到振荡器594的PWM电路592。PWM电路592向联接到第一晶体管输出级598a的第一栅极驱动电路596a提供第一信号,以驱动第一RF+(左)能量输出端。PWM电路592还向联接到第二晶体管输出级598b的第二栅极驱动电路596b提供第二信号,以驱动第二RF-(右)能量输出端。电压传感器599联接在RF左/RF输出端子之间,以测量输出电压。驱动电路586、第一驱动电路596a和第二驱动电路596b以及第一晶体管输出级598a和第二晶体管输出级598b限定第一级放大器电路。在操作中,控制电路210(图14)产生采用电路诸如直接数字合成(DDS)电路1500、1600(图65和图66)的数字波形1800(图67)。DAC 590接收数字波形1800并将其转换成模拟波形,该模拟波形由第一级放大器电路接收和放大。
图35为根据本公开的一个方面的联接到图34所示电路702的变压器704的示意图。变压器704的RF左/RF输入端子(主绕组)电联接到电路702的RF左/RF输出端子。次绕组的一侧与第一阻塞电容器706和第二阻塞电容器708串联联接。第二阻塞电容器联接到RF+574a端子。次绕组的另一侧联接到RF-574b端子。如前所述,RF+574a输出端联接到超声刀516(图30),并且RF-574b接地端子联接到外管544(图30)。在一个方面,变压器166的匝数比n1:n2为1:50。
图36为根据本公开的一个方面的电路710的示意图,该电路包括用于高功率能量/驱动电路和低功率电路的单独功率源。功率源712包括一次电池组和二次电池组,该一次电池组包括通过开关718连接到电路710中的第一一次电池715和第二一次电池717(例如,锂离子电池);该二次电池组包括当功率源712插入电池组件时通过开关723连接到该电路中的二次电池720。二次电池720是防降电池,其具有抗γ或其它辐射灭菌的部件。例如,可结合开关模式功率源727和电池组件内的任选充电电路,以允许二次电池720减少一次电池715、717的电压下降。这保证了在手术开始时充满电的电池容易引入无菌区。一次电池715、717可用于直接为马达控制电路726和能量电路732供电。功率源/电池组712可包括双型电池组件,该双型电池组件包括一次锂离子电池715、717和二次NiMH电池720,以与专用能量电池720一起控制来自专用能量电池715、717的柄部电子电路730,从而运行马达控制电路726和能量电路732。在该情况下,当涉及驱动能量电路732和/或马达控制电路726的一次电池715、717电量低时,电路710从涉及驱动柄部电子电路730的二次电池720中拉出。在一个不同方面,电路710可包括单向二极管,该单向二极管将不允许电流沿相反方向流动(例如,从驱动能量和/或马达控制电路所涉及的电池流动到驱动电子电路所涉及的电池)。
另外,可提供伽马友好充电电路,该电路包括使用二极管和真空管部件的开关模式功率源727,以将电压下降最小化在预定水平。通过包括作为NiMH电压(3个NiMH电池)的分压的最小下降电压,可省去开关模式功率源727。另外,可提供模块化系统,其中辐射硬化的部件位于模块中,使得模块可通过辐射灭菌来灭菌。其它非辐射硬化的部件可包括在其它模块化部件中,并且在模块化部件之间进行连接,使得部件一起操作,就像部件一起位于同一电路板上一样。如果仅需要两个NiMH电池,则基于二极管和真空管的开关模式功率源727允许可灭菌电子器件在一次性一次电池组内。
现在转向图37,示出了根据本公开的一个方面的用于与图30和图31所示的外科器械500一起使用且用于操作电池801供电的RF发生器电路802的控制电路800。外科器械500被构造成能够使用超声振动和高频电流来对活组织进行外科凝固/切割治疗,并且使用高频电流来对活组织进行外科凝固治疗。
图37示出了控制电路800,该控制电路允许双发生器系统在RF发生器电路802与超声发生器电路820(类似于图11和图12所示的电路177)能量模态之间切换,以用于图30和图31所示的外科器械500。在一个方面,检测RF信号中的电流阈值。当RF能量用作组织的治疗源时,在组织的阻抗较低的情况下,通过组织的高频电流较高。根据一个方面,位于外科器械500上的视觉指示器812或光可被构造成能够在该高电流时段期间处于打开状态。当电流下降到阈值以下时,视觉指示器812处于关闭状态。因此,光电晶体管814可被构造成能够检测从打开状态到关闭状态的转换并且脱离RF能量,如图37所示的控制电路800所示。因此,当能量按钮被释放并且能量开关826断开时,控制电路800被复位并且RF发生器电路802和超声发生器电路820都保持关闭。
参考图30至图33以及图37,在一个方面,提供了一种管理RF发生器电路802和超声发生器电路820的方法。如前所述,RF发生器电路802和/或超声发生器电路820可位于柄部组件502、超声换能器/RF发生器组件504、电池组件506、轴组件510和/或喷嘴700中。如果能量开关826关闭(例如,断开),则控制电路800保持在复位状态。因此,当能量开关826断开时,控制电路800被复位并且RF发生器电路802和超声发生器电路820都关闭。当能量开关826被挤压并且能量开关826被接合(例如,闭合)时,RF能量被递送到组织,并且当组织阻抗较低时,由电流感测升压变压器804操作的视觉指示器812将被点亮。来自视觉指示器812的光提供逻辑信号以使超声发生器电路820处于关闭状态。一旦组织阻抗增加到阈值以上并且通过组织的高频电流减小到阈值以下,视觉指示器812关闭并且光转换为关闭状态。由该转换产生的逻辑信号关闭继电器808,由此RF发生器电路802关闭并且超声发生器电路820打开,以完成凝结和切割循环。
仍然参考图30至图33以及图37,在一个方面,双发生器电路802、820构造采用用于一种模态的电池801供电的板载RF发生器电路802,以及第二板载超声发生器电路820,该第二板载超声发生器电路可板载在柄部组件502、电池组件506、轴组件510、喷嘴700和/或超声换能器/RF发生器组件504中。超声发生器电路820也是电池801操作的。在各个方面,RF发生器电路802和超声发生器电路820可为柄部组件502的集成部件或可分离部件。根据各个方面,将双RF/超声发生器电路802、820作为柄部组件502的一部分可省去在外科器械500的环境中进行复杂布线的需要。RF/超声发生器电路802、820可被构造成能够在同时利用无绳发生器系统的能力时提供现有发生器的全部能力。
任何一种类型的系统都可对不相互通信的模态进行单独控制。外科医生根据他们的判断单独激活RF和超声。另一种方法是提供完全集成的通信方案,这些方案共享按钮、组织状态、仪器操作参数(例如,钳口闭合、力等)和算法,以管理组织治疗。可实现该集成的各种组合以提供适当级别的功能和性能。
在一个方面,控制电路800包括电池801供电的RF发生器电路802,该电路包括电池作为能量源。如图所示,RF发生器电路802联接到两个导电表面(本文称为“电极806a、806b”),并且被构造成能够用RF能量(例如,高频电流)驱动电极806a、806b。升压变压器804的第一绕组810a与双极RF发生器电路802和返回电极806b中的一个极串联连接。在一个方面,第一绕组810a和返回电极806b连接到双极RF发生器电路802的负极。双极RF发生器电路802的另一极通过继电器808的开关接触件809或任何合适的电磁切换装置(包括电枢,其由电磁体836移动以操作开关接触件809)连接到有源电极806a。当电磁体836通电时开关接触件809闭合,并且当电磁体836断电时开关接触件809断开。当开关接触件闭合时,RF电流流过位于电极806a、806b之间的导电组织(未示出)。应当理解,在一个方面,有源电极806a连接到双极RF发生器电路802的正极。
视觉指示器电路805包括升压变压器804、串联电阻器R2和视觉指示器812。视觉指示器812可适于与外科器械500以及其它电外科系统和工具(诸如,本文所述的那些系统和工具)一起使用。升压变压器804的第一绕组810a与返回电极806b串联连接,并且升压变压器804的第二绕组810b与电阻器R2和视觉指示器812串联连接,该视觉指示器包括例如NE-2型氖灯泡。
在操作中,当继电器808的开关接触件809断开时,有源电极806a与双极RF发生器电路802的正极断开连接,并且没有电流流过组织、返回电极806b以及升压变压器804的第一绕组810a。因此,视觉指示器812不通电并且不发光。当继电器808的开关接触件809闭合时,有源电极806a连接到双极RF发生器电路802的正极,使得电流能够流过组织、返回电极806b以及升压变压器804的第一绕组810a,以在组织上操作,例如切割和烧灼组织。
第一电流作为位于有源电极806a和返回电极806b之间的组织的阻抗的函数流过第一绕组810a,从而提供升压变压器804的第一绕组810a两端的第一电压。在升压变压器804的第二绕组810b两端感应出升压的第二电压。次级电压出现在电阻器R2两端并且对视觉指示器812通电,使得当通过组织的电流大于预定阈值时,氖灯泡变亮。应当理解,电路和部件值是例示性的,并不限于此。当继电器808的开关接触件809闭合时,电流流过组织并且视觉指示器812打开。
现在转向控制电路800的能量开关826部分,当能量开关826处于断开位置时,逻辑高电平被施加到第一反相器828的输入端,并且逻辑低电平被施加到与门832的两个输入端中的一个。因此,与门832的输出较低,并且晶体管834关闭以防止电流流过电磁体836的绕组。在电磁体836处于断电状态的情况下,继电器808的开关接触件809保持断开并且防止电流流过电极806a、806b。第一反相器828的逻辑低输出也被施加到第二反相器830,使得输出变高并且使触发器818(例如,D型触发器)复位。此时,Q输出变低以关闭超声发生器电路820,并且
Figure BDA0001767737420000491
输出变高并被施加到与门832的另一输入端。
当用户按压器械柄部上的能量开关826以向电极806a、806b之间的组织施加能量时,能量开关826闭合并且在第一反相器828的输入端处施加逻辑低电平,该第一反相器的输入端向与门832的其它输入端施加逻辑高电平,使得与门832的输出变高并打开晶体管834。在打开状态中,晶体管834通过电磁体836的绕组传导和灌入电流,以对电磁体836通电并且闭合继电器808的开关接触件809。如上所述,当组织位于电极806a、806b之间时,在开关接触件809闭合的情况下,电流可流过电极806a、806b和升压变压器804的第一绕组810a。
如上所述,流过电极806a、806b的电流的大小取决于位于电极806a、806b之间的组织的阻抗。最初,组织阻抗较低,并且通过组织和第一绕组810a的电流的大小较高。因此,施加在第二绕组810b上的电压足够高以打开视觉指示器812。视觉指示器812发出的光打开光电晶体管814,该光电晶体管将反相器816的输入拉低并使反相器816的输出变高。施加到触发器818的CLK的高输入对触发器818的Q或
Figure BDA0001767737420000492
输出没有影响,并且Q输出保持较低而
Figure BDA0001767737420000493
输出保持较高。因此,当视觉指示器812保持通电时,超声发生器电路820关闭,并且超声换能器822和超声刀824不被激活。
随着电极806a、806b之间的组织变干燥,由于流过组织的电流会产生热量,因此组织的阻抗增加并且通过其中的电流减小。当通过第一绕组810a的电流减小时,第二绕组810b两端的电压也减小,并且当该电压下降到操作视觉指示器812所需的最小阈值以下时,视觉指示器812和光电晶体管814关闭。当光电晶体管814关闭时,逻辑高电平被施加到反相器816的输入端,并且逻辑低电平被施加到触发器818的CLK输入端,以将逻辑高电平设为Q输出,并且将逻辑低电平设为
Figure BDA0001767737420000494
输出。Q输出处的逻辑高电平打开超声发生器电路820以激活超声换能器822和超声刀824,从而开始切割位于电极806a、806a之间的组织。在超声发生器电路820打开的同时或几乎同时,触发器818的
Figure BDA0001767737420000495
输出变低并且使与门832的输出变低并关闭晶体管834,从而使电磁体836断电并且断开继电器808的开关接触件809,从而切断电流流过电极806a、806b。
当继电器808的开关接触件809断开时,没有电流流过电极806a、806b、组织以及升压变压器804的第一绕组810a。因此,没有电压在第二绕组810b两端形成,并且没有电流流过视觉指示器812。
当用户挤压器械柄部上的能量开关826以保持能量开关826闭合时,触发器818的Q和
Figure BDA0001767737420000501
输出的状态保持相同。因此,超声刀824保持激活并且继续切割端部执行器的钳口之间的组织,而没有电流从双极RF发生器电路802流过电极806a、806b。当用户释放器械柄部上的能量开关826时,能量开关826断开并且第一反相器828的输出变低而第二反相器830的输出变高,以使触发器818复位从而使Q输出变低,并且关闭超声发生器电路820。同时,
Figure BDA0001767737420000502
输出变高并且电路现在处于关闭状态并准备好使用户致动器械柄部上的能量开关826以闭合能量开关826,向位于电极806a、806b之间的组织施加电流,并且如上所述重复向组织施加RF能量和向组织施加超声能量的循环。
图38为根据本公开的一个方面的端部执行器900的剖视图。端部执行器900包括超声刀902和钳口构件904。钳口构件904具有通道形沟槽906,端部执行器900的一部分沿轴向方向接合在该沟槽中。通道形沟槽906具有较宽的通道形状,其中在与钳口构件904的轴线正交的截面中具有较宽的开口。钳口构件904由导电材料制成,并且绝缘构件910沿轴向方向设置在通道形状的底表面部分912上超声刀902接触的范围内。
超声刀902具有在与轴向方向正交的截面中局部切出的菱形形状。超声刀902的截面形状是在与如图38所示的菱形形状的较长对角线正交的方向上切出的形状。具有在截面形状中切出的菱形形状的一部分的超声刀902具有梯形部分914,该梯形部分接合在钳口构件904的通道形沟槽906中。菱形形状的一部分未在截面形状中切出的部分是超声刀902的等腰三角形部分916。
当柄部组件的触发器闭合时,超声刀902和钳口构件904彼此配合。当它们配合时,通道形沟槽906的底表面部分912邻接在超声刀902的梯形部分914的顶表面部分918上,并且通道形沟槽906的两个内壁部分920邻接在梯形部分914的倾斜表面部分922。
此外,超声刀902的等腰三角形部分916的顶点部分924被形成为圆形,但顶点部分924具有略微尖锐的角度。
当外科器械用作刮刀超声治疗器械时,超声刀902充当超声振动治疗部分,并且顶端部分924及其周边部分(由虚线示出)特别地充当手术刀用于治疗对象的组织。
此外,当外科器械用作刮刀高频治疗器械时,顶点部分924及其周边部分(由虚线示出)充当电手术刀用于治疗对象的组织。
在一个方面,底表面部分912和内壁部分920以及顶表面部分918和倾斜表面部分922充当超声振动的工作表面。
此外,在一个方面,内壁部分920和倾斜表面部分922充当双极高频电流的工作表面。
在一个方面,外科器械可用作同时输出超声和高频电流的刮刀治疗器械,超声刀902充当超声振动治疗部分,并且顶点部分924及其周边部分(由虚线示出)特别地充当电手术刀用于治疗对象的组织。
此外,当外科器械同时输出超声和高频电流时,底表面部分912和顶表面部分918充当超声振动的工作表面,并且内壁部分920和倾斜表面部分922充当双极高频电流的工作表面。
因此,根据图37所示的治疗部分的构造,不仅在将外科器械用作超声治疗器械或高频治疗器械的情况下,而且在将外科器械用作超声治疗器械或高频电流治疗器械的情况下,并且进一步在将外科器械用于同时输出超声和高频的情况下,都提供了优异的可操作性。
当外科器械执行高频电流输出或者同时输出高频电流和超声时,可启用单极输出而不是双极输出作为高频输出。
图39为根据本公开的一个方面的端部执行器930的剖视图。钳口构件932由导电材料制成,并且绝缘构件934沿轴向方向设置在通道形状的底表面部分936上。
超声刀938具有在与轴向方向正交的截面中局部切出的菱形形状。超声刀938的截面形状是其中在与如图39所示的一条对角线正交的方向上切出菱形形状的一部分的形状。具有在截面形状中切出的菱形形状的一部分的超声刀938具有梯形部分940,该梯形部分接合在钳口构件932的通道形沟槽942中。菱形形状的一部分未在截面形状中切出的部分是端部执行器900的等腰三角形部分944。
当柄部组件的触发器闭合时,超声刀938和钳口构件906彼此配合。当它们配合时,通道形沟槽942的底表面部分936邻接在超声刀938的梯形部分940的顶表面部分946上,并且通道形沟槽932的两个内壁部分954邻接在梯形部分940的倾斜表面部分948。
此外,超声刀938的等腰三角形部分944的顶点部分950被形成为圆形,但钩形状的内侧的顶点部分952具有略微尖锐的角度。顶点部分952的角度θ优选为45°至100°。45°是超声刀938的强度极限。如上所述,超声刀938的顶点部分952将突出部分构造为在钩形状部分的内侧即边缘部分处具有预定角度。
钩形状中的治疗部分通常用于解剖。端部执行器930的顶点部分952在解剖时成为工作部分。由于顶点部分952具有略微尖锐的角度θ,因此顶点部分952对于解剖治疗是有效的。
图39所示的超声刀938和钳口构件932分别在超声输出时、在高频输出时以及在同时输出超声和高频率时执行与图38所示的超声刀938和钳口构件932相同的操作,除了上述在解剖时的操作之外。
现在参考图40至图43,示出了可操作地联接到插入护套1001的端部执行器1000,该插入护套由外部护套1002和内部护套1004形成。端部执行器1000包括超声刀1006和钳口构件1014。在外部护套1002中,导电金属管的外侧覆盖有绝缘树脂管。内部护套1004是导电金属管。内部护套1004可相对于外部护套1002轴向地来回移动。
超声刀1006由具有高声学效果和生物相容性的导电材料(例如钛合金,诸如Ti-6Al-4V合金)制成。在超声刀1006中,绝缘和弹性橡胶衬里1008配备在超声振动的节点的位置外部。橡胶衬里1008以压缩状态设置在内部护套1004和超声刀1006之间。超声刀1006通过橡胶衬里1008保持在内部护套1004上。在内部护套1004与超声刀1006之间保持有间隙。
邻接部分1010由超声刀1012的在超声刀1006的远侧端部部分处面对钳口构件1014的部分形成。这里,超声刀1012在其与超声刀1006的轴向方向垂直的横截面中呈八边形。邻接表面1016由邻接部分1010的面向钳口构件1014的一个表面形成。一对电极表面1018由设置到邻接表面1016的侧面的表面形成。
钳口构件1014由主体构件1020、电极构件1022、垫构件1024和作为调节部分的调节构件1026形成。
主体构件1020由硬质导电材料制成。主体构件1020的近侧端部部分构成枢轴连接部分1028。枢轴连接部分1028经由枢轴连接轴1030可枢转地连接到外部护套1002的远侧端部部分。枢轴连接轴1030在与轴向方向和打开/闭合方向垂直的宽度方向上延伸。主体构件1020可相对于外部护套1002在打开/闭合方向上围绕枢轴连接轴1030转动。内部护套1004的远侧端部部分在设置到枢轴连接轴1030的远侧和打开方向侧的位置处可枢转地连接到主体构件1020的枢轴连接部分1028。如果可移动柄部相对于柄部单元中的固定柄部转动,则内部护套1004相对于外部护套1002来回移动,并且主体构件1020由内部护套1004驱动以相对于外部护套1002在打开/闭合方向上围绕枢轴连接轴1030转动。在一个方面,主体构件1020的远侧部分构成一对枢轴支承1032。一对枢轴支承1032为板形式,其在轴向方向上延伸并垂直于宽度方向,并且在宽度方向上彼此分开设置。
电极构件1022由硬质导电材料制成。设置在打开方向侧的电极构件1022部分构成枢轴支撑件1034。插入孔1036在宽度方向上穿过枢轴支撑件1034形成。枢轴支撑轴1038穿过插入孔1036插入并且在宽度方向上延伸。枢轴支撑件1034设置在主体构件1020的一对枢轴支承1032之间,并且经由枢轴支撑轴1038可枢转地支撑在一对枢轴支承1032上。电极构件1022可相对于主体构件1020围绕枢轴支撑轴1038振荡。此外,设置在闭合方向侧的电极构件1022部分构成电极节段1040。电极节段1040在轴向方向上延伸并且在宽度方向上向侧面突出。朝向闭合方向开口的凹陷沟槽1042在设置在闭合方向侧上的电极节段1040部分中在轴向方向上延伸。在设置在闭合方向侧的沟槽1042部分中轴向地设置有齿,从而形成齿部分1044。限定沟槽1042的侧表面构成一对电极接收表面1046,该对电极接收表面在宽度方向上从闭合方向朝向侧面倾斜。朝向闭合方向开口的凹陷配合容座1048在限定沟槽1042的底部部分中轴向延伸。嵌入孔1050垂直于插入孔1036在打开/闭合方向上穿过电极构件1022的枢轴支撑件1034形成。嵌入孔1050向配合容座1048开口。
垫构件1024比超声刀1006更软,并且由具有生物相容性的绝缘材料诸如聚四氟乙烯制成。垫构件1024与电极构件1022的配合容座1048配合。设置在闭合方向侧上的垫构件1024部分从电极构件1022向闭合方向突出,从而形成邻接容座1052。在垂直于轴向方向的横截面中,邻接容座1052呈与超声刀1012的邻接部分1010的突出形状相对应的凹陷形状。当钳口构件1014相对于超声刀1012闭合时,超声刀1012的邻接部分1010邻接在垫构件1024的邻接容座1052上并与之接合。超声刀1012的一对电极表面1018平行于电极节段1040的一对电极接收表面1046布置,并且在电极节段1040与超声刀1012之间保持有间隙。
调节构件1026比超声刀1006更硬,并且由绝缘高强度材料诸如陶瓷制成。调节垫构件1024呈销形。调节垫构件1024插入电极构件1022的枢轴支撑件1034的嵌入孔1050中,朝向电极节段1040的配合容座1048突出,并且嵌入配合容座1048中的垫构件1024的邻接容座1052中。调节构件1026的闭合方向端构成调节端1054。调节端1054不从邻接容座1052向闭合方向突出,并且容纳在邻接容座1052中。插入孔1036也穿过调节构件1026形成,并且枢转支撑轴1038穿过调节构件1026的插入孔1036插入。
这里,内部护套1004、主体构件1020和电极构件1022彼此电连接,并且构成高频外科治疗中使用的第一电通路1056。电极构件1022的电极节段1040用作高频外科治疗中使用的双极电极之一。在一个方面,超声刀1006构成高频治疗中使用的第二电通路1058。设置到超声刀1006的远侧端部部分的超声刀1012用作高频治疗中使用的另一个双极电极。如上所述,超声刀1006通过绝缘橡胶衬里1008保持在内部护套1004上,并且在内部护套1004与超声刀1006之间保持有间隙。这防止了内部护套1004与超声刀1006之间发生短路。当钳口构件1014相对于超声刀1012闭合时,超声刀1012的邻接部分1010邻接在垫构件1024的邻接容座1052上并与之接合。因此,超声刀1012的一对电极表面1018平行于电极节段1040的一对电极接收表面1046布置,并且在电极节段1040与超声刀1012之间保持有间隙。这防止了电极节段1040与超声刀1012之间发生短路。
参见图44,垫构件1024比超声超声刀1006更软。因此,当钳口构件1014相对于超声刀1012闭合并且超声刀1012的邻接部分1010邻接在垫构件1024的邻接容座1052上并且与之接合时,超声刀1012超声振动,在该情况下,邻接容座1052被超声刀1012磨损。当邻接容座1052被磨损时,在邻接部分1010与邻接容座1052摩擦接合的情况下,电极节段1040与超声刀1012之间的间隙逐渐减小。当邻接容座1052被磨损超过预定量时,调节构件1026的调节端1054在闭合方向上从邻接容座1052暴露。当调节端1054在闭合方向上从邻接容座1052暴露时,如果钳口构件1014相对于超声刀1012闭合,则在电极节段1040接触超声刀1012之前,调节端1054接触超声刀1012。因此,调节了超声刀1012与电极节段1040之间的接触。这里,电极节段1040和超声刀1012是硬质的。因此,当超声振动的超声刀1012接触电极节段1040时,超声刀1012快速且重复地与电极节段58接触和脱离接触。当高频电压被施加在电极节段1040与超声刀1012之间时,在超声刀1012与电极节段1040之间出现火花。在一个方面,超声刀1012与电极节段1040之间的接触由调节构件1026的调节端1054调节,从而防止出现火花。调节构件1026由绝缘材料制成,并且相对于电极构件1022电绝缘。因此,如果超声振动的超声刀1012接触调节构件1026的调节端1054,则即使当超声刀1012快速且重复地与调节端1054接触和脱离接触时,在调节端1054与超声刀1012之间也不会出现火花。这防止了超声刀1012与钳口构件1014之间出现火花。
调节构件1026由比超声刀1006更硬的高强度材料制成。因此,当调节端1054接触超声振动的超声刀1012时,调节构件1026不会被磨损,并且超声刀1006会破裂。在根据一个方面的外科治疗系统中,当邻接容座1052被磨损超过预定量时,调节端1054接触超声刀1012以有意使超声刀1006破裂。通过检测该裂缝,检测外科治疗器械的寿命终点。因此,超声刀1012与调节端1054之间的接触位置被设定在超声刀1012中的应力集中区域,以确保当调节端1054接触超声刀1012时超声刀1006破裂。在线性超声刀1006中,应力集中在超声振动的节点的位置,并且应力集中区域位于超声刀1012的近侧端部部分。
对于组合超声/电外科器械的更详细描述,参考美国专利号8,696,666和美国专利号8,663,223,以上专利各自以引用方式并入本文。
图45示出了根据本公开的一个方面的具有远侧关节运动件的模块化电池供电手持式电外科器械1100。外科器械1100包括柄部组件1102、刀驱动组件1104、电池组件1106、轴组件1110和端部执行器1112。端部执行器1112包括附连到其远侧端部的呈相对关系的一对钳口构件1114a、1114b。端部执行器1112被构造成能够进行关节运动和旋转。图46为根据本公开的一个方面的图45所示外科器械1100的分解图。与外科器械1100一起使用以密封和切割组织的端部执行器1112包括呈相对关系的一对钳口构件1114a、1114b,该对钳口构件可相对于彼此移动以抓持其间的组织。钳口构件1114a、1114b包括钳口外壳和导电表面1116a、1116b(例如,电极),这些导电表面适于连接到电外科能量源(RF源),使得导电表面能够通过保持在其间的组织传导电外科能量,以实现组织密封。导电表面1116b中的一个包括限定在其中并且沿其长度延伸的通道,该通道与连接到设置在刀驱动组件1104中的马达的驱动杆1145连通。刀被构造成能够沿通道平移和往复运动,以切割抓持在钳口构件1114a、1114b之间的组织。
图47为根据本公开的一个方面的具有位于柄部组件1102上的显示器的图45和图46所示外科器械1100的透视图。图45至图47所示的外科器械的柄部组件1102包括马达组件1160和显示组件。显示组件包括例如可移除地连接到柄部组件1102的外壳1148部分的显示器1176,诸如LCD显示器。显示器1176提供外科规程参数的视觉显示,诸如组织厚度、密封状态、切割状态、组织厚度、组织阻抗、正执行的算法、电池容量等参数。
图48为根据本公开的一个方面的不具有位于柄部组件1102上的显示器的图45和图46所示器械的透视图。图48所示的外科器械1150的柄部组件1102包括单独外壳1156上的不同显示组件1154。现在参考图45至图48,外科器械1100、1150被构造成能够使用高频(RF)电流和刀来对活组织进行外科凝固/切割治疗,并且使用高频电流来对活组织进行外科凝固治疗。可利用算法或用户输入控制独立地或组合地施加高频(RF)电流。显示组件、电池组件1106和轴组件1110是可移除地连接到柄部组件1102的模块化部件。马达1140位于在柄部组件1102内。本文结合图34至图37和图50描述了RF发生器电路和马达驱动电路,这些电路例如位于外壳1148内。
轴组件1110包括外管1144、刀驱动杆1145和内管(未示出)。轴组件1110包括关节运动节段1130和远侧旋转节段1134。端部执行器1112包括呈相对关系的钳口构件1114a、1114b以及马达驱动刀。钳口构件1114a、1114b包括联接到RF发生器电路的导电表面1116a、1116b,用于将高频电流递送到抓持在相对钳口构件1114a、1114b之间的组织。钳口构件1114a、1114b可围绕枢轴销1136可枢转地旋转,以抓持钳口构件1114a、1114b之间的组织。钳口构件1114a、1114b可操作地联接到触发器1108,使得当触发器1108被挤压时,钳口构件1114a、1114b闭合以抓持组织,并且当触发器1108被释放时,钳口构件1114a、1114b打开以释放组织。
钳口构件1114a、1114b可操作地联接到触发器1108,使得当触发器1108被挤压时,钳口构件1114a、1114b闭合以抓持组织,并且当触发器1108被释放时,钳口构件1114a、1114b打开以释放组织。在一级触发器构造中,触发器1108被挤压以闭合钳口构件1114a、1114b,并且一旦钳口构件1114a、1114b闭合,开关部分1121的第一开关1121a被激活以对RF发生器通电,从而密封组织。在密封组织之后,开关部分1120的第二开关1121b被激活以推进刀,从而切割组织。在各个方面,触发器1108可为两级或多级触发器。在两级触发器构造中,在第一级期间,触发器1108被挤压部分路程以闭合钳口构件1114a、1114b,并且在第二级期间,触发器1108被挤压剩余路程以对RF发生器电路通电,从而密封组织。在密封组织之后,第一开关1121a和第二开关1121b中的一个被激活以推进刀,从而切割组织。在切割组织之后,通过释放触发器1108打开钳口构件1114a、1114b,从而释放组织。在另一方面,力传感器诸如应变仪或压力传感器可联接到触发器1108,以测量用户施加到触发器1108的力。在另一方面,力传感器诸如应变仪或压力传感器可联接到开关部分1120即第一开关1121a和第二开关1121b按钮,使得位移强度对应于用户施加到开关部分1120即第一开关1121a和第二开关1121b按钮的力。
电池组件1106通过电连接器1132电连接到柄部组件1102。柄部组件1102设置有开关部分1120。第一开关1121a和第二开关1121b设置在开关部分1120中。通过致动第一开关1121a来对RF发生器通电,并且通过致动第二开关1121b来对马达1140通电从而激活刀。因此,第一开关1121a对RF电路通电以驱动高频电流通过组织,从而形成密封,并且第二开关1121b对马达通电以驱动刀,从而切割组织。电池组件1106的结构和功能方面类似于结合图1、图2以及图16至图24所述的用于外科器械100的电池组件106的结构和功能方面。因此,为了使公开内容简洁和清楚,电池组件106的此类结构和功能方面以引用方式并入本文,并且这里不再重复。
旋钮1118可操作地联接到轴组件1110。使旋钮1118在箭头1126所示的方向上旋转±360°使得外管1144在箭头1119的相应方向上旋转±360°。在一个方面,另一个旋钮1122可被构造成能够使端部执行器1112在箭头1128所示的方向上旋转±360°,而与外管1144的旋转无关。端部执行器1112可通过第一控制开关1124a和第二控制开关1124b进行关节运动,使得致动第一控制开关1124a使端部执行器1112在箭头1132a所示的方向上围绕枢轴1138进行关节运动,并且致动第二控制器开关1124b使端部执行器1112在箭头1132b所示的方向上围绕枢轴1138进行关节运动。此外,外管1144可具有在例如5mm至10mm范围内的直径D3
图49为根据本公开的一个方面的可与外科器械1100、1150一起使用以驱动刀的马达组件1160。马达组件1160包括马达1162、行星式齿轮1164、轴1166和驱动齿轮1168。齿轮可以可操作地联接以驱动刀杆1145(图46)。在一个方面,驱动齿轮1168或轴1166可操作地联接到结合图50所述的旋转驱动机构1170,以驱动远侧头部旋转、关节运动和钳口闭合。
图50为根据本公开的一个方面的马达驱动电路1165的示图。马达驱动电路1165适用于驱动马达M,马达M可用在本文所述的外科器械1100、1150中。马达M由包括四个开关S1-S4的H桥驱动。开关S1-S4通常是固态开关,诸如MOSFET开关。为了使马达M在一个方向上转动,两个开关S1、S4接通,而另外两个开关S3、S1断开。为了使马达M的方向反转,使开关S1-S4的状态反转,使得开关S1、S4断开,而另外两个开关S3、S1接通。可将电流感测电路放置在马达驱动电路1165中,以感测马达电流i1a、i2a、i1b、i2b
图51示出了根据本公开的一个方面的用以驱动远侧头部旋转、关节运动和钳口闭合的旋转驱动机构1170。旋转驱动机构1170具有可操作地联接到马达组件1160的主旋转驱动轴1172。主旋转驱动轴1172能够利用位于轴组件1110的外管1144内的离合器机构来选择性地联接到至少两个独立的致动机构(第一致动机构、第二致动机构、两者、非两者)。主旋转驱动轴1172联接到独立的离合器,这些离合器允许轴功能独立地联接到旋转驱动轴1172。例如,关节运动离合器1174被接合以使轴组件1110围绕关节运动区段1130的关节运动轴线1175进行关节运动。远侧头部旋转离合器1178被接合以旋转远侧旋转节段1134,并且钳口闭合离合器1179被接合以闭合端部执行器1112的钳口构件1114a、1114b。通过刀驱动杆1145推进和回缩刀。旋转机构中的全部、没有一个或任何组合可在任何时候联接。
在一个方面,微电离合构造使得远侧旋转节段1134能够旋转并且关节运动节段1130能够围绕枢轴1138和关节运动轴线1175进行关节运动。在一个方面,磁流体离合器经由流体泵将离合器联接到主旋转驱动轴1172。离合器磁流体由包在刀驱动杆1145周围的电线圈1181、1183、1185激活。线圈1181、1183、1185的另一端连接到三个单独的控制电路,以独立地致动离合器1174、1178、1179。在操作中,当线圈1181、1183、1185不通电时,离合器1174、1178、1179脱离接合并且没有关节运动、旋转或钳口运动。
当通过对线圈1181通电而使关节运动离合器1174接合并且通过使线圈1183、1185断电而使远侧头部旋转离合器1178和钳口闭合离合器1179脱离接合时,齿轮1180机械地联接到主旋转驱动轴1172以使关节运动节段1130进行关节运动。在所示的取向中,当主旋转驱动轴1172顺时针旋转时,齿轮1180顺时针旋转并且轴围绕关节运动轴线1175在右侧方向上进行关节运动,并且当主旋转驱动轴1172逆时针旋转时,齿轮1180逆时针旋转并且轴围绕关节运动轴线1175在左侧方向上进行关节运动。应当理解,左侧/右侧关节运动取决于外科器械1100、1150的取向。
当通过使线圈1181、1185断电而使关节运动离合器1174和钳口闭合离合器1179脱离接合并且通过对线圈1183通电而使远侧头部旋转离合器1178接合时,主旋转驱动轴1172使远侧旋转节段1134在相同的旋转方向上旋转。当对线圈1183通电时,远侧头部旋转离合器1178使主旋转驱动轴1172与远侧旋转节段1134接合。因此,远侧旋转节段1134与主旋转驱动轴1172一起旋转。
当通过使线圈1181、1183断电而使关节运动离合器1174和远侧头部旋转离合器1178脱离接合并且通过对线圈1185通电而使钳口闭合离合器1179接合时,钳口构件1114a、114b可打开或闭合,具体取决于主旋转驱动轴1172的旋转。当对线圈1185通电时,钳口闭合离合器1179接合系留内螺纹驱动构件1186,该构件在主旋转驱动轴1172的方向上就位旋转。系留内螺纹驱动构件1186包括与外螺纹驱动构件1188螺纹接合的外螺纹,该外螺纹驱动构件包括内螺纹表面。当主旋转驱动轴1172顺时针旋转时,与系留内螺纹驱动构件1186螺纹接合的外螺纹驱动构件1188将在近侧方向1187上被驱动以闭合钳口构件1114a、1114b。当主旋转驱动轴1172逆时针旋转时,与系留内螺纹驱动构件1186螺纹接合的外螺纹驱动构件1188将在远侧方向1189上被驱动以打开钳口构件1114a、1114b。
图52为根据本公开的一个方面的端部执行器组件的放大左侧透视图,其中钳口构件被示出处于打开构型。图53为根据本公开的一个方面的图52的端部执行器组件的放大右侧视图。现在参考图52和图53,为被示出处于打开位置以接近组织的端部执行器1112的放大视图。钳口构件1114、1114b通常是对称的并且包括类似的部件特征,这些部件特征配合以允许围绕枢轴销1136灵活旋转,从而实现组织的密封和分割。因此并且除非另有说明,否则本文仅详细描述了钳口构件1114a以及与其相关联的操作特征,但是可以理解,许多这些特征也适用于另一个钳口构件1114b。
钳口构件1114a还包括钳口外壳1115a、绝缘基板或绝缘体1117a以及导电表面1116a。绝缘体1117a被构造成能够牢固地接合导电密封表面1116a。这可通过冲压、通过重叠注塑、通过重叠注塑冲压的导电密封板和/或通过重叠注塑金属注塑密封板来实现。这些制造技术能够生产具有导电表面1116a的电极,该导电表面被绝缘体1117a围绕。
如上所述,钳口构件1114b包括类似的元件,包括:钳口外壳1115b;绝缘体1117b;以及导电表面1116b,其尺寸被设计为牢固地接合绝缘体1117b。导电表面1116b和绝缘体1117b在被组装时形成穿过其限定的纵向取向的刀通道1113,用于刀1123的往复运动。刀通道1113便于刀1123沿预定切割平面进行纵向往复运动,以有效且精确地沿形成的组织密封分离组织。尽管未示出,但是钳口构件1114a也可包括刀通道,该刀通道与刀通道1113配合以便于刀穿过组织平移。
钳口构件1114a、1114b彼此电隔离,使得电外科能量可有效地传递通过组织以形成组织密封。导电表面1116a、1116b也与端部执行器1112和外管1144的其余操作部件隔离。可采用多个止动构件来调节导电表面1116a、1116b之间的间隙距离,以确保组织密封准确、一致和可靠。
电池组件1106的结构和功能方面类似于结合图1、图2以及图16至图24所述的用于外科器械100的电池组件106的结构和功能方面,包括结合图20至图24所述的电池电路。因此,为了使公开内容简洁和清楚,电池组件106的此类结构和功能方面以引用方式并入本文,并且这里不再重复。此外,RF发生器电路的结构和功能方面类似于在结合图34至图37所述的外科器械500、600中描述的RF发生器电路的结构和功能方面。因此,为了使公开内容简洁和清楚,RF发生器电路的这种结构和功能方面以引用方式并入本文,并且这里不再重复。此外,外科器械1100包括结合图12至图15所述的电池和控制电路,包括例如结合图14所述的控制电路210和结合图15所述的电路300。因此,为了使公开内容简洁和清楚,对结合图12至图15所述的电路的描述以引用方式并入本文,并且这里不再重复。
对于包括切割机构和关节运动节段(可操作以使端部执行器偏离轴的纵向轴线)的电外科器械的更详细描述,参考美国专利号9,028,478和美国专利号9,113,907,以上专利各自以引用方式并入本文。
图54示出了根据本公开的一个方面的具有远侧关节运动件的模块化电池供电手持式电外科器械1200。外科器械1200包括柄部组件1202、刀驱动组件1204、电池组件1206、轴组件1210和端部执行器1212。端部执行器1212包括附连到其远侧端部的呈相对关系的一对钳口构件1214a、1214b。端部执行器1212被构造成能够进行关节运动和旋转。图55为根据本公开的一个方面的图54所示外科器械1200的分解图。与外科器械1200一起使用以密封和切割组织的端部执行器1212包括呈相对关系的一对钳口构件1214a、1214b,该对钳口构件可相对于彼此移动以抓持其间的组织。钳口构件1214a、1214b可包括钳口外壳和导电表面1216a、1216b(例如,电极),这些导电表面适于连接到电外科能量源(RF源),使得导电表面能够通过保持在其间的组织传导电外科能量,以实现组织密封。钳口构件1214a、1214b和导电表面1216a、1216b包括限定在其中并且沿其长度延伸的通道,该通道与连接到刀驱动组件1204的刀驱动杆1245连通。刀1274(图60至图61)被构造成能够沿通道平移和往复运动,以切割抓持在钳口构件1214a、1214b之间的组织。该刀具有I形梁构造,使得当刀1274通过通道推进时,钳口构件1214a、1214b更加靠近在一起。在一个方面,导电表面1216a、1216b相对于彼此偏移。刀1274包括尖锐的远侧端部。
图54至图55所示的外科器械的柄部组件1202包括马达组件1260和刀驱动组件1204。在一个方面,显示组件可设置在外壳1248上。显示组件可包括例如可移除地连接到柄部组件1202的外壳1248部分的显示器,诸如LCD显示器。LCD显示器提供外科规程参数的视觉显示,诸如组织厚度、密封状态、切割状态、组织厚度、组织阻抗、正执行的算法、电池容量等参数。现在参考图54至图55,外科器械1200被构造成能够使用高频(RF)电流和刀1274(图60至图61)来对活组织进行外科凝固/切割治疗,并且使用高频电流来对活组织进行外科凝固治疗。可利用算法或用户输入控制独立地或组合地施加高频(RF)电流。刀驱动组件1204、电池组件1206和轴组件1210是可移除地连接到柄部组件1202的模块化部件。马达组件1240可位于柄部组件1202内。结合图34至图37和图50描述了RF发生器电路和马达驱动电路,这些电路例如位于外壳1248内。外壳1248包括可移除盖板1276,以提供通向位于外壳1248内的电路和机构的入口。刀驱动组件1204包括可操作地联接到柄部组件1202和开关部分1220的齿轮和连杆,以激活和驱动刀1274。如下文更详细所述,刀1274具有I形梁构造。
轴组件1210包括外管1244、刀驱动杆1245和内管(未示出)。轴组件1210包括关节运动节段1230。端部执行器1212包括一对钳口构件1214a、1214b和刀1274,该刀被构造成能够与在钳口构件1214a、1214b中形成的通道一起往复运动。在一个方面,刀1274可由马达驱动。钳口构件1214a、1214b包括联接到RF发生器电路的导电表面1216a、1216b,用于将高频电流递送到抓持在钳口构件1214a、1214b之间的组织。钳口构件1214a、1214b可围绕枢轴销1235可枢转地旋转,以抓持钳口构件1214a、1214b之间的组织。钳口构件1214a、1214b可操作地联接到触发器1208,使得当触发器1208被挤压时,钳口构件1214a、1214b中的一个或两个闭合以抓持组织,并且当触发器1208被释放时,钳口构件1214a、1214b打开以释放组织。在所示的示例中,一个钳口构件1214a可相对于另一个钳口构件1214b移动。在其它方面,两个钳口构件1214a、1214b可相对于彼此移动。在另一方面,力传感器诸如应变仪或压力传感器可联接到触发器1208,以测量用户施加到触发器1208的力。在另一方面,力传感器诸如应变仪或压力传感器可联接到开关部分1220即第一开关1221a和第二开关1221b按钮,使得位移强度对应于用户施加到开关部分1220即第一开关1221a和第二开关1221b按钮的力。
钳口构件1214a可操作地联接到触发器1208,使得当触发器1208被挤压时,钳口构件1214a闭合以抓持组织,并且当触发器1208被释放时,钳口构件1214a打开以释放组织。在一级触发器构造中,触发器1208被挤压以闭合钳口构件1214a,并且一旦钳口构件1214a闭合,开关部分1220的第一开关1221a被激活以对RF发生器通电,从而密封组织。在密封组织之后,开关部分1220的第二开关1221b被激活以推进刀,从而切割组织。在各个方面,触发器1208可为两级或多级触发器。在两级触发器构造中,在第一级期间,触发器1208被挤压部分路程以闭合钳口构件1214a,并且在第二级期间,触发器1208被挤压剩余路程以对RF发生器电路通电,从而密封组织。在密封组织之后,开关1221a、1221b中的一个被激活以推进刀,从而切割组织。在切割组织之后,通过释放触发器1208打开钳口构件1214a,从而释放组织。
轴组件1210包括关节运动节段1230,该关节运动节段可操作以使端部执行器1212偏离轴组件1210的纵向轴线“A”。转盘1232a、1232b可操作以使细长轴组件1210的远侧端部处的关节运动节段1230相对于纵向轴线A-A枢转到各种关节运动取向。更具体地将,关节运动转盘1232a、1232b可操作地联接到与轴组件1210的关节运动节段1230操作地连通的多条缆线或腱件,如下文更详细地描述。一个关节运动转盘1232a可在箭头“C0”的方向上旋转,以在第一平面(例如,如箭头“C1”所示的垂直平面)中引起枢转运动。类似地,另一个关节运动转盘1232b可在沿箭头“D0”的方向上旋转,以在第二平面(例如,如箭头“D1”所示的水平平面)中引起枢转运动。关节运动转盘1232a、1232b在箭头“C0”或“D0”的任一方向上旋转导致腱件使轴组件1210围绕关节运动节段1230枢转或进行关节运动。
电池组件1206通过电连接器1231电连接到柄部组件1202。柄部组件1202设置有开关部分1220。第一开关1221a和第二开关1221b设置在开关部分1220中。通过致动第一开关1221a来对RF发生器通电,并且可通过致动第二开关1221b来对马达组件1240通电从而激活刀1274。因此,第一开关1221a对RF电路通电以驱动高频电流通过组织,从而形成密封,并且第二开关1221b对马达通电以驱动刀1274,从而切割组织。在其它方面,可使用两级触发器1208构造来手动击发刀1274。电池组件1206的结构和功能方面类似于结合图1、图2以及图16至图24所述的用于外科器械100的电池组件106的结构和功能方面。因此,为了使公开内容简洁和清楚,电池组件106的此类结构和功能方面以引用方式并入本文,并且这里不再重复。
旋钮1218可操作地联接到轴组件1210。使旋钮1218在箭头1226所示的方向上旋转±360°使得外管1244在箭头1228的相应方向上旋转±360°。可通过控制按钮使端部执行器1212进行关节运动,使得致动控制按钮使端部执行器1212在箭头C1和D1所示的一个方向上进行关节运动。此外,外管1244可具有在例如5mm至10mm范围内的直径D3
图56为根据本公开的一个方面的包括电连接件的图54所示关节运动节段的放大区域细节图。图57为根据本公开的一个方面的包括电连接件的图56所示关节运动节段的放大区域细节图。现在参考图56至图57,示出了关节运动节段1230可操作地设置在轴组件1210上或者在近侧端部与远侧端部1222之间分别联接到该轴组件。在图56至图57所示的方面中,关节运动节段1230由多个关节运动链节1233(链节1233)限定。链节1233被构造成能够使轴组件1210在水平或垂直平面(见图54)中横跨纵向轴线“A-A”横向进行关节运动。出于例示性目的,轴组件1210被示出为横跨水平平面进行关节运动。
链节1233共同限定穿过其的中心环孔1238,该中心环孔被构造成能够接收穿过其的驱动机构,例如驱动杆。可以理解,中心环孔1238的构造为穿过其的驱动杆提供了足够的间隙。中心环孔1238限定穿过其的轴线“B-B”,当轴组件1210处于非关节运动构造时,该轴线平行于纵向轴线“A-A”,见图54。
继续参考图56至图57,链节1233经由腱件1234可操作地联接到关节运动转盘1232a、1232b。出于例示性目的,示出了四(4)个腱件1234。腱件1234可由不锈钢线材或适用于将拉力传递到链节1233的最远侧链节的其它材料构成。无论使用何种构造材料,腱件1234都表现出能够在腱件1234的长度上放大的弹性比率,因此当外部负载被施加到细长轴组件1210时,腱件1234可趋于拉伸。该拉伸趋势可能与无意改变细长轴组件1210的远侧端部1222的取向有关,例如在外科医生没有启动关节运动转盘1232a、1232b的相应运动的情况下。
腱件1234可操作地联接到关节运动转盘1232a、1232b,这些关节运动转盘被构造成能够在旋转关节运动转盘1232a、1232b时致动腱件1234,例如“拉动”腱件1234。多个腱件1234经由一种或多种合适的联接方法可操作地联接到链节1233。更具体地讲,链节1233包括在限定在其中的相应多个第一开孔或孔口1236a(在代表性图中示出了四(4)个孔口1236a),这些开孔或孔口沿链节1233径向设置并且沿公共轴线居中对齐,见图56。多个孔口1236a中的一个孔口被构造成能够接收腱件1234。腱件1234的远侧端部通过合适的方法(例如,上述联接方法中的一种或多种)可操作地联接到链节1233的最远侧链节。
继续参考图56至图57,链节1233包括第二多个孔口1236b(在代表性图中示出了四个(4)孔口1236b,如图56最佳所示)。孔口1236b被构造成能够接收多条导电引线1237(在代表性图中示出了四(4)条导电引线1237)中的相应导电引线。导电引线1237被构造成能够在第二多个孔口1236b内在第一状态与第二状态之间转换。为了便于导电引线1237转换,当导电引线1237处于第一状态时,孔口1236b的直径大于导电引线1237的直径。
外科器械1220包括电路,该电路被构造成能够选择性地感应电压和电流流向多条导电引线1237,使得导电引线1237从第一状态转换为第二状态。为此,发生器G提供适当比例的电压电位Eo。电压在导电引线1237中感应并且电流流过其中。流过导电引线1237的电流使导电引线1237从第一状态(图56)转变为第二状态(图57)。在第二状态中,导电引线1237在导电引线1237和相应孔口1236b之间提供过盈配合,如图57最佳所示。
图58示出了根据本公开的一个方面的图54的外科器械1200的轴组件1210、端部执行器1212和切割构件1254的部件的透视图。图59示出了根据本公开的一个方面的第二级关节运动件中的关节运动节段。现在参考图58至图59,一个关节运动带1256a可滑动地设置在隔板1261的一个侧凹陷部中,而第二关节运动带1256b(图59)可滑动地设置在隔板1261的另一个侧凹陷部中。切割构件驱动管可纵向运动以纵向驱动驱动块1258,从而使切割构件1254纵向运动。侧凹陷部包括纵向延伸的沟槽,这些沟槽被构造成能够减小与关节运动带1256a、1256b的接触表面积,从而减小隔板1261与关节运动带1256a、1256b之间的摩擦。隔板1261也可由低摩擦材料形成并且/或者包括表面处理以降低摩擦。关节运动带1256a、1256b沿轴组件1210的长度(包括通过关节运动节段1230)纵向延伸。一个关节运动带1256a的远侧端部1252在锚定点处固定到端部执行器1212的近近侧部分1250的一侧。第二关节运动带1256b的远侧端部1262在锚定点处固定到端部执行器1212的近侧部分1250的另一侧。旋转关节运动钮可操作以选择性地向远侧推进关节运动带1256a,同时向近侧回缩第二关节运动带1256b,反之亦然。应当理解,该相对平移会导致关节运动节段1230弯曲,从而使端部执行器1212进行关节运动。具体地讲,端部执行器1212将朝向朝近侧回缩的任意关节运动带1256a、1256b偏转;并且远离向远侧推进的任意关节运动带1256a、1256b偏转。
继续参考图58至图59,示出了相互作用以使关节运动节段1230弯曲从而使端部执行器1212进行关节运动的多个上述部件。在图58中,关节运动件1230为直线构造。然后,旋转关节运动转盘1232a、1232b(图54至图55)中的一个,导致一个导螺杆向近侧平移而另一个导螺杆向远侧推进。一个导螺杆的该近侧平移向近侧拉动关节运动带1256b,导致关节运动节段1230开始弯曲,如图59所示。关节运动节段1230的该弯曲向远侧拉动另一个关节运动带1256a。响应于旋转关节运动转盘1232a、1232b而向远侧推进导螺杆使得关节运动带1256a和驱动构件能够向远侧推进。在一些其它型式中,向远侧推进导螺杆主动地向远侧驱动驱动构件和关节运动带1256a。当用户继续旋转关节运动转盘1232a、1232b中的一个时,上述相互作用以相同的方式继续进行,从而导致关节运动节段1230进一步弯曲,如图59所示。应当理解,在相反方向上旋转关节运动转盘1232a、1232b会导致关节运动节段1230变直,并且在相反方向上进一步旋转会导致关节运动节段1230在相反方向上弯曲。
图60示出了根据本公开的一个方面的处于打开构型的图54至图59的装置的端部执行器1212的透视图。本示例的端部执行器1212包括一对钳口构件1214a、1214b。在本示例中,一个钳口构件1214b相对于轴组件固定;而另一个钳口构件1214a朝向和远离另一个钳口构件1214b相对于轴组件枢转。在一些型式中,致动器诸如杆或缆线等可延伸穿过护套并且在枢转联接件处与一个钳口构件1214a结合,使得致动器杆/缆线等穿过轴组件的纵向运动提供钳口构件1214a相对于轴组件并且相对于第二钳口构件1214b的枢转。当然,钳口构件1214a、1214b也可具有任何其它合适类型的运动并且可以任何其它合适的方式被致动。仅以举例的方式,钳口构件1214a、1214b可通过击发梁1266的纵向平移被致动并且因此闭合,使得在一些型式中可简单地省去致动器杆/缆线等。一个钳口构件1214a的上侧包括多个齿状锯齿1272。应当理解,另一个钳口构件1214b的下侧可包括与锯齿1272嵌套的互补锯齿1277,以增强对捕获在端部执行器1212的钳口构件1214a,1214b之间的组织的抓持,而不会撕裂组织。
图61示出了根据本公开的一个方面的处于闭合构型并且具有远侧位置的刀1274的图60的端部执行器1212的横剖端视图。现在参考图60至图61,一个钳口构件1214a限定纵向延伸的细长狭槽1268;而另一个钳口构件1214b还限定了纵向延伸的细长狭槽1270。另外,一个钳口构件1214a的下侧具有导电表面1216a;而另一个钳口构件1214b的顶侧具有另一个导电表面1216b。导电表面1216a、1216b经由沿轴组件的长度延伸的一个或多个导体(未示出)与电源1278和控制器1280连通。电源1278可操作以将RF能量以第一极性递送到第一导电表面1216b并且以第二(相反)极性递送到第二导电表面1216a,使得RF电流在导电表面1216a、1216b之间流动,从而通过捕获在钳口构件1214a、1214b之间的组织。在一些型式中,击发梁1266用作电导体,该电导体与导电表面1216a、1216b(例如,作为接地回路)配合以递送捕获在钳口构件1214a、1214b之间的双极RF能量。电源1278可在外科器械1200外部或可与外科器械1200集成(例如,在柄部组件1202等中),如在本文列出的一篇或多篇参考文献或者其它地方所述。控制器1280调节从电源1278到导电表面1216a、1216b的功率输送。控制器1280也可在外科器械1200外部或可与外科器械1200集成(例如,在柄部组件1202等中),如在本文列出的一篇或多篇参考文献或者其它地方所述。还应当理解,导电表面1216a、1216b可以各种替代位置、构造和关系提供。
仍然参考图60至图61,本示例的外科器械1200包括可沿端部执行器1212的一部分长度纵向移动的击发梁1266。击发梁1266同轴地定位在轴组件1210内,沿轴组件1210的长度延伸,并且在轴组件1210(在本示例中包括关节运动节段1230)内纵向平移,但应当理解,击发梁1266和轴组件1210可具有任何其它合适的关系。击发梁1266包括具有尖锐远侧端部的刀1274、上凸缘1281和下凸缘1282。如图61最佳所示,刀1274延伸穿过钳口构件1214a、1214b的狭槽1268、1270,其中上凸缘1281位于钳口构件1214a上方的凹陷部1284中,并且下凸缘1282位于钳口构件1214b下方的凹陷部中1286。刀1274和凸缘1281、1282的构造在击发梁1266的远侧端部处提供了“I形梁”型横截面。虽然在本示例中凸缘1281、1282仅沿击发梁1266的一小部分长度纵向延伸,但应当理解,凸缘1281、1282可沿击发梁1266的任何合适长度纵向延伸。另外,虽然凸缘1281、1282沿钳口构件1214a、1214b的外部定位,但是凸缘1281、1282可替代地设置在钳口构件1214a、1214b内形成的相应狭槽中。例如,钳口构件1214a、1214b可限定“T”形狭槽,其中刀1274的一部分设置在“T”形狭槽的一个垂直部分中,并且凸缘1281、1282设置在“T”形狭槽的水平部分中。参考本文的教导内容,各种其它合适的构造和关系对于本领域的普通技术人员而言将是显而易见的。仅以举例的方式,端部执行器1212可包括一个或多个正温度系数(PTC)热敏电阻器主体1288、1290(例如,PTC聚合物等),这些热敏电阻器主体位于导电表面1216a、1216b附近和/或其它地方。
电池组件1206的结构和功能方面类似于结合图1、图2以及图16至图24所述的用于外科器械100的电池组件106的结构和功能方面,包括结合图20至图24所述的电池电路。因此,为了使公开内容简洁和清楚,电池组件106的此类结构和功能方面以引用方式并入本文,并且这里不再重复。此外,RF发生器电路的结构和功能方面类似于在结合图34至图37所述的外科器械500、600中描述的RF发生器电路的结构和功能方面。因此,为了使公开内容简洁和清楚,RF发生器电路的这种结构和功能方面以引用方式并入本文,并且这里不再重复。此外,外科器械1200包括结合图12至图15所述的电池和控制电路,包括例如结合图14所述的控制电路210和结合图15所述的电路300。因此,为了使公开内容简洁和清楚,对结合图12至图15所述的电路的描述以引用方式并入本文,并且这里不再重复。
对于包括切割机构和关节运动节段(可操作以使端部执行器偏离轴的纵向轴线)的电外科器械的更详细描述,参考美国公布号2013/0023868,该公布以引用方式并入本文。
还应当理解,可对本文所述的外科器械100、480、500、600、1100、1150、1200中的任一者进行改进,以包括用于驱动原本手动移动的部件的马达或其它电动装置。这类改进的各种示例在美国公布号2012/0116379和美国公布号2016/0256184中描述,以上公布各自以引用方式并入本文。参考本文的教导内容,可将马达或其它电动装置结合到本文的装置中的任一者中的各种其它合适的方式对于本领域的普通技术人员而言将是显而易见的。
还应当理解,结合图11至图15、图20至图24、图34至图37以及图50所述的电路可被构造成能够单独操作或与本文所述的外科器械100、480、500、600、1100、1150、1200中的任一者组合操作。
图62至图70描述了被构造成能够与结合图1至图61所述的外科器械100、480、500、600、1100、1150、1200中的任一者一起操作的各种电路。现在转向图62,示出了根据本公开的一个方面的外科器械的控制电路1300的部件。控制电路1300包括联接到易失性存储器1304、一个或多个传感器1306、非易失性存储器1308和电池1310的处理器1302。在一个方面,外科器械可包括柄部外壳,以容纳控制电路1300并容纳通用控制器,从而实现节能模式。在一些方面,处理器1302可为外科器械的包括一个或多个辅处理器的主处理器。在一些方面,处理器1302可存储在电池1310内。处理器1302被构造成能够通过执行机器可执行指令(诸如,控制程序或其它软件模块)来控制外科器械的各种操作和功能。例如,处理器1302执行能量模态控制程序使外科医生能够使用外科器械来选择施加到患者组织的特定能量类型。外科器械可包括位于外科器械的柄部上的能量模态致动器。致动器可为滑块、拨动开关、分段瞬时接触开关或一些其它类型的致动器。致动能量模态致动器使得处理器1302激活对应于所选能量类型的能量模态。能量类型可为超声、RF或者超声和RF能量的组合。在各个方面,处理器1302如图63所示电联接到外科器械的多个电路段,以根据通电和断电序列激活或停用电路段。
当处理器1302在操作中时,诸如当处理器1302执行控制程序或软件模块时,易失性存储器1304诸如随机存取存储器(RAM)临时存储所选的控制程序或其它软件模块。一个或多个传感器1306可包括力传感器、温度传感器、电流传感器或运动传感器。在一些方面,一个或多个传感器1306可位于轴、端部执行器、电池或柄部或者其任何组合或子组合处。一个或多个传感器1306传输与结合图1至图61所述的外科器械100、480、500、600、1100、1150、1200中的任一者的操作相关联的数据,诸如端部执行器的钳口所抓持的组织的存在或马达所施加的力。在一个方面,一个或多个传感器1306可包括加速度计,以基于安全检查和加电自检(POST)来验证电路段的功能或操作。机器可执行指令诸如控制程序或其它软件模块存储在非易失性存储器1308中。例如,非易失性存储器1308存储基本输入/输出系统(BIOS)程序。非易失性存储器1308可为只读存储器、可擦除可编程ROM(EPROM)、EEPROM、闪速存储器或一些其它类型的非易失性存储器装置。控制程序的各种示例在美国公布号2015/0272578中描述,该公布以引用方式全文并入本文。电池1310通过提供引起电流的源电压为外科器械供电。电池1310可包括图63所示的马达控制电路段1428。
在一个方面,处理器1302可为任何单核或多核处理器,诸如已知的由TexasInstruments生产的商品名为ARM Cortex的那些处理器。在一个方面,处理器1302可被实施为已知同样由Texas Instruments生产的商品名为Hercules ARM Cortex R4的安全处理器,其包括两个基于微控制器的系列,诸如TMS570和RM4x。然而,可不受限制地采用微控制器和安全处理器的其它合适的替代物。在一个方面,安全处理器可具体地被构造用于IEC61508和ISO 26262安全关键应用等,以在递送可扩展的性能、连接性和存储器选项时提供高级集成安全特征。
在某些方面,处理器1302可为例如可购自Texas Instruments的LM 4F230H5QR。在至少一个示例中,Texas Instruments LM4F230H5QR是ARM Cortex-M4F处理器内核,其包括高达40MHz的256KB单周期闪速存储器或其它非易失性存储器的芯片上存储器、40MHz以上的用于提高性能的预取缓冲区、32KB单周期串行随机存取存储器(SRAM)、加载有
Figure BDA0001767737420000701
软件的内置只读存储器(ROM)、2KB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(QED)模拟、一个或多个具有12个模拟输入通道的12位模数转换器(ADC),以及可用于产品数据表的易得的其它特征结构。可以很方便地换用其它处理器,因此,本公开不应限于这一上下文。
图63为根据本公开的一个方面的包括多个独立操作的电路段1402、1414、1416、1420、1424、1428、1434、1440的分段电路1401的系统图1400。分段电路1401的多个电路段中的电路段包括一个或多个电路以及存储在一个或多个存储器装置中的一组或多组机器可执行指令。电路段的一个或多个电路联接,以便通过一个或多个有线或无线连接介质进行电通信。多个电路段被构造成能够在三种模式之间转换,包括睡眠模式、待机模式和操作模式。
在所示的一个方面,多个电路段1402、1414、1416、1420、1424、1428、1434、1440首先在待机模式下启动,然后转换到睡眠模式,之后转换到操作模式。然而,在其它方面,多个电路段可从三种模式中的任何一种转换到三种模式中的任何另一种。例如,多个电路段可直接从待机模式转换到操作模式。基于处理器1302执行机器可执行指令,电压控制电路1408可将单独电路段置于特定状态。这些状态包括断电状态、低能状态和通电状态。断电状态对应于睡眠模式,低能状态对应于待机模式,并且通电状态对应于操作模式。可通过例如使用电位计来实现到低能状态的转换。
在一个方面,多个电路段1402、1414、1416、1420、1424、1428、1434、1440可根据通电序列从睡眠模式或待机模式转换到操作模式。多个电路段也可根据断电序列从操作模式转换到待机模式或睡眠模式。通电序列和断电序列可不同。在一些方面,通电序列包括仅对多个电路段中的电路段的子集通电。在一些方面,断电序列包括仅使多个电路段中的电路段的子集断电。
重新参考图63中的系统图1400,分段电路1401包括多个电路段,包括转换电路段1402、处理器电路段1414、柄部电路段1416、通信电路段1420、显示器电路段1424、马达控制电路段1428、能量治疗电路段1434和轴电路段1440。转换电路段包括唤醒电路1404、升压电流电路1406、电压控制电路1408、安全控制器1410和POST控制器1412。转换电路段1402被构造成能够实现断电和通电序列、安全检测协议和POST。
在一些方面,唤醒电路1404包括加速计按钮传感器1405。在各方面,转换电路段1402被构造成能够处于通电状态,而分段电路1401的多个电路段中的其它电路段被构造成能够处于低能状态、断电状态或通电状态。加速计按钮传感器1405可监测本文结合图1至图61所述的外科器械100、480、500、600、1100、1150、1200中的任一者的移动或加速。例如,移动可为外科器械的取向或旋转变化。外科器械可通过例如外科器械的使用者相对于三维欧几里德空间在任何方向上移动。当加速计按钮传感器1405感测到移动或加速时,加速计按钮传感器1405向电压控制电路1408发送信号以使电压控制电路1408向处理器电路段1414施加电压,从而将处理器1302和易失性存储器1304转换到通电状态。在各方面,在电压控制电路1409向处理器1302和易失性存储器1304施加电压之前,处理器1302和易失性存储器1304处于通电状态。在操作模式下,处理器1302可启动通电序列或断电序列。在各个方面,加速计按钮传感器1405也可向处理器1302发送信号以使处理器1302启动通电序列或断电序列。在一些方面,当大多数单独电路段处于低能状态或断电状态时,处理器1302启动通电序列。在其它方面,当大多数单独电路段处于通电状态时,处理器1302启动断电序列。
除此之外或另选地,加速计按钮传感器1405可感测外科器械的预定附近区域内的外部移动。例如,加速计按钮传感器1405可感测本文结合图1至图61所述的外科器械100、480、500、600、1100、1150、1200中的任一者的用户在预定的附近区域内移动该用户的手。当加速度计按钮传感器1405感测到该外部移动时,加速度计按钮传感器1405可向电压控制电路1408发送信号并向处理器1302发送信号,如前所述。在接收到所发送的信号之后,处理器1302可启动通电序列或断电序列,以使一个或多个电路段在三种模式之间转换。在各方面,发送到电压控制电路1408的信号被发送,以验证处理器1302处于操作模式。在一些方面,加速度计按钮传感器1405可感测外科器械何时下降,并且基于所感测的下降向处理器1302发送信号。例如,该信号可指示单独电路段的操作中的错误。一个或多个传感器1306可感测受影响的单独电路段的损坏或故障。基于所感测的损坏或故障,POST控制器1412可执行相应的单独电路段的POST。
可基于加速计按钮传感器1405来定义通电序列或断电序列。例如,加速计按钮传感器1405可感测特定运动或一系列运动,这些运动指示多个电路段中的特定电路段的选择。基于所感测的运动或一系列感测到的运动,当处理器1302处于通电状态时,加速计按钮传感器1405可向处理器1302传输包括多个电路段中的一个或多个电路段的指示的信号。基于该信号,处理器1302确定包括所选择的一个或多个电路段的通电序列。除此之外或另选地,本文结合图1至图61所述的外科器械100、480、500、600、1100、1150、1200中的任一者的用户可基于与外科器械的图形用户界面(GUI)的相互作用来选择电路段的数目和顺序以定义通电序列或断电序列。
在各个方面,只有当加速度计按钮传感器1405检测到本文结合图1至图61所述的外科器械100、480、500、600、1100、1150、1200中的任一者的移动或者检测到预定阈值以上的预定附近区域内的外部移动时,加速度计按钮传感器1405才可向电压控制电路1408发送信号并向处理器1302发送信号。例如,只有感测到移动持续5秒或更多秒或者只有外科器械移动5英寸或更多英寸,才可发送信号。在其它方面,只有当加速计按钮传感器1405检测到外科器械的振荡移动时,加速度计按钮传感器1405才可向电压控制电路1408发送信号并向处理器1302发送信号。预定阈值减少了外科器械的电路段的无意转换。如前所述,转变可包括根据通电序列转换到操作模式,根据断电序列转换到低能模式,或者根据断电序列转换到睡眠模式。在一些方面,外科器械包括可由外科器械的用户致动的致动器。通过加速计按钮传感器1405感测致动。致动器可为滑块、拨动开关或瞬时接触开关。基于所感测的致动,加速计按钮传感器1405可向电压控制电路1408发送信号并向处理器1302发送信号。
升压电流电路1406联接到电池1310。升压电流电路1406是电流放大器诸如继电器或晶体管,并且被构造成能够放大单独电路段的电流的大小。电流的初始大小对应于电池1310提供给分段电路1401的源电压。合适的继电器包括螺线管。合适的晶体管包括场效应晶体管(FET)、MOSFET和双极结型晶体管(BJT)。升压电流电路1406可放大对应于单独电路段或电路的电流的大小,该电路段或电路在结合图1至图61所述的外科器械100、480、500、600、1100、1150、1200中的任一者的操作期间需要更多的电流消耗。例如,当外科器械的马达需要更多输入功率时,可使到马达控制电路段1428的电流增加。使单独电路段的电流增加可能导致另一个电路段或多个电路段的电流相应减小。除此之外或另选地,电流增加可对应于结合电池1310操作的附加电压源提供的电压。
电压控制电路1408联接到电池1310。电压控制电路1408被构造成能够向多个电路段提供电压或从多个电路段移除电压。电压控制电路1408还被构造成能够增加或减小提供给分段电路1401的多个电路段的电压。在各个方面,电压控制电路1408包括组合逻辑电路(诸如,用于选择输入的多路复用器(MUX))、多个电子开关和多个电压转换器。多个电子开关中的电子开关可被构造成能够在断开和闭合构造之间切换,以使单独电路段与电池1310断开连接或连接到该电池。多个电子开关可为固态装置,诸如晶体管或其它类型的开关,诸如无线开关、超声波开关、加速度计、惯性传感器等。组合逻辑电路被构造成能够选择单独的电子开关以切换到断开构造,从而使得能够向相应电路段施加电压。组合逻辑电路还被构造成能够选择单独的电子开关以切换到闭合构造,从而使得能够从相应电路段移除电压。通过选择多个单独的电子开关,组合逻辑电路可实现断电序列或通电序列。多个电压转换器可向多个电路段提供升压电压或降压电压。电压控制电路1408还可包括微处理器和存储器装置,如图62所示。
安全控制器1410被构造成能够对电路段执行安全检查。在一些方面,当一个或多个单独电路段处于操作模式时,安全控制器1410执行安全检查。可执行安全检查以确定电路段的功能或操作中是否存在任何错误或缺陷。安全控制器1410可监测多个电路段的一个或多个参数。安全控制器1410可通过将一个或多个参数与预定参数进行比较来验证多个电路段的身份和操作。例如,如果选择RF能量模态,则安全控制器1410可验证轴的关节运动参数与预定关节运动参数匹配,以验证结合图1至图61所述的外科器械100、480、500、600、1100、1150、1200中的任一者的RF能量模态的操作。在一些方面,安全控制器1410可通过传感器1306监测外科器械的一个或多个特性之间的预定关系,从而检测故障。当一个或多个特性与预定关系不一致时,可能出现故障。当安全控制器1410确定存在故障、存在错误或者未验证多个电路段的一些操作时,安全控制器1410阻止或禁用故障、错误或验证失败所发生的特定电路段的操作。
POST控制器1412执行POST,以验证多个电路段的正确操作。在一些方面,在电压控制电路1408向单独电路段施加电压以使单独电路段从待机模式或睡眠模式转换到操作模式之前,对多个电路段中的单独电路段执行POST。如果单独电路段未通过POST,则该特定电路段不会从待机模式或睡眠模式转换到操作模式。柄部电路段1416的POST可包括例如测试柄部控制传感器1418是否感测到结合图1至图61所述的外科器械100、480、500、600、1100、1150、1200中的任一者的柄部控制的致动。在一些方面,POST控制器1412可向加速计按钮传感器1405传输信号,以作为POST的一部分验证单独电路段的操作。例如,在接收到信号之后,加速计按钮传感器1405可提示外科器械的用户将外科器械移动到多个不同的位置以确认外科器械的操作。加速度计按钮传感器1405还可作为POST的一部分监测电路段的输出或电路段的电路。例如,加速计按钮传感器1405可感测马达1432所产生的增量马达脉冲以验证操作。马达控制电路1430的马达控制器可用于控制马达1432以产生增量马达脉冲。
在各个方面,可使用包括附加加速计按钮传感器的结合图1至图61所述的外科器械100、480、500、600、1100、1150、1200中的任一者。POST控制器1412还可执行存储在电压控制电路1408的存储器装置中的控制程序。控制程序可使POST控制器1412从多个电路段传输请求匹配的加密参数的信号。未能从单独电路段接收到匹配的加密参数向POST控制器1412指示相应的电路段被损坏或发生故障。在一些方面,如果POST控制器1412基于POST确定处理器1302被损坏或发生故障,则POST控制器1412可向一个或多个辅处理器发送信号,以使一个或多个辅处理器执行处理器1302无法执行的关键功能。在一些方面,如果POST控制器1412基于POST确定一个或多个电路段不能正常操作,则POST控制器1412可启动正常操作的那些电路段的降低性能模式,同时锁定未通过POST或不能正常操作的那些电路段。锁定电路段可与待机模式或睡眠模式下的电路段类似地起作用。
处理器电路段1414包括参考图62所述的处理器1302和易失性存储器1304。处理器1302被构造成能够启动通电或断电序列。为了启动通电序列,处理器1302向电压控制电路1408传输通电信号,以使电压控制电路1408根据通电序列向多个电路段中的多个或子集施加电压。为了启动断电序列,处理器1302向电压控制电路1408传输断电信号,以使电压控制电路1408根据断电序列从多个电路段中的多个或子集移除电压。
柄部电路段1416包括柄部控制传感器1418。柄部控制传感器1418可感测本文结合图1至图61所述的外科器械100、480、500、600、1100、1150、1200中的任一者的一个或多个柄部控件的致动。在各个方面,一个或多个柄部控件包括夹持控件、释放按钮、关节运动开关、能量激活按钮和/或任何其它合适的柄部控件。用户可激活能量激活按钮以在RF能量模式、超声能量模式或者RF和超声能量模式的组合之间进行选择。柄部控制传感器1418还可便于将模块化柄部附接到外科器械。例如,柄部控制传感器1418可感测模块化柄部到外科器械的正确附接并且指示所感测的到外科器械的用户的附接。LCD显示器1426可提供所感测的附件的图形指示。在一些方面,柄部控制传感器1418感测一个或多个柄部控件的致动。基于所感测的致动,处理器1302可启动通电序列或断电序列。
通信电路段1420包括通信电路1422。通信电路1422包括通信接口,以便于多个电路段中的单独电路段之间进行信号通信。在一些方面,通信电路1422为本文结合图1至图61所述的外科器械100、480、500、600、1100、1150、1200中的任一者的模块化部件提供用于进行电通信的路径。例如,模块化轴和模块化换能器在同时附接到外科器械的柄部时可通过通信电路1422将控制程序上载到柄部。
显示器电路段1424包括LCD显示器1426。LCD显示器1426可包括液晶显示屏幕、LED指示器等。在一些方面,LCD显示器1426是有机发光二极管(OLED)屏幕。可将显示器226置于本文结合图1至图61所述的外科器械100、480、500、600、1100、1150、1200中的任一者上、嵌入任一者中或远离任一者定位。例如,可将显示器226可置于外科器械的柄部上。显示器226被构造成能够向用户提供传感反馈。在各个方面,LCD显示器1426还包括背光。在一些方面,外科器械还可包括音频反馈装置诸如扬声器或蜂鸣器以及触觉反馈装置诸如触觉致动器。
马达控制电路段1428包括联接到马达1432的马达控制电路1430。马达1432通过驱动器和晶体管诸如FET联接到处理器1302。在各个方面,马达控制电路1430包括与处理器1302信号通信的马达电流传感器,以向处理器1302提供指示马达的电流消耗的测量结果的信号。处理器向显示器226传输信号。显示器226接收信号并显示马达1432的电流消耗的测量结果。处理器1302可使用该信号例如来监测马达1432的电流消耗存在于可接受的范围内,以将电流消耗与多个电路段的一个或多个参数进行比较并且确定患者治疗部位的一个或多个参数。在各个方面,马达控制电路1430包括用于控制马达操作的马达控制器。例如,马达控制电路1430诸如通过调节马达1432的速度、扭矩和加速度来控制各种马达参数。基于由马达电流传感器测量的通过马达1432的电流来完成调节过程。
在各个方面,马达控制电路1430包括力传感器,以测量马达1432所产生的力和扭矩。马达1432被构造成能够致动本文结合图1至图61所述的外科器械100、480、500、600、1100、1150、1200中的任一者的机构。例如,马达1432被构造成能够控制外科器械的轴的致动,以实现夹持、旋转和关节运动功能。例如,马达1432可致动轴以利用外科器械的钳口实现夹持运动。马达控制器可确定钳口所夹持的材料是组织还是金属。马达控制器还可确定钳口夹持材料的程度。例如,马达控制器可基于所感测的马达电流或马达电压的导数来确定钳口的打开或闭合程度。在一些方面,马达1432被构造成能够致动换能器,以使换能器向柄部施加扭矩或控制外科器械的关节运动。马达电流传感器可与马达控制器相互作用以设定马达电流极限。当电流满足预定阈值极限时,马达控制器启动马达控制操作的相应变化。例如,超过马达电流极限会使马达控制器减小马达的电流消耗。
能量治疗电路段1434包括RF放大器和安全电路1436以及超声信号发生器电路1438,以实现结合图1至图61所述的外科器械100、480、500、600、1100、1150、1200中的任一者的能量模块化功能。在各个方面,RF放大器和安全电路1436被构造成能够通过生成RF信号来控制外科器械的RF模态。超声信号发生器电路1438被构造成能够通过生成超声信号来控制超声能量模态。RF放大器和安全电路1436以及超声信号发生器电路1438可结合操作以控制RF和超声能量模态的组合。
轴电路段1440包括轴模块控制器1442、模块化控制致动器1444、一个或多个端部执行器传感器1446以及非易失性存储器1448。轴模块控制器1442被构造成能够控制多个轴模块,这些轴模块包括将由处理器1302执行的控制程序。多个轴模块实现轴模态,诸如超声、超声和RF的组合、RF的I-刀和RF相对钳口。轴模块控制器1442可通过选择轴模块来选择相应的轴模态以供处理器1302执行。模块化控制致动器1444被构造成能够根据所选择的轴模态致动轴。在启动致动之后,轴根据特定于所选择的轴模态和所选择的端部执行器模态的一个或多个参数、例程或程序来使端部执行器进行关节运动。位于端部执行器处的一个或多个端部执行器传感器1446可包括力传感器、温度传感器、电流传感器或运动传感器。一个或多个端部执行器传感器1446基于端部执行器所实施的能量模态来传输关于端部执行器的一个或多个操作的数据。在各个方面,能量模态包括超声能量模态、RF能量模态或者超声能量模态和RF能量模态的组合。非易失性存储器1448存储轴控制程序。控制程序包括特定于轴的一个或多个参数、例程或程序。在各个方面,非易失性存储器1448可为ROM、EPROM、EEPROM或闪速存储器。非易失性存储器1448存储对应于本文结合图1至图61所述的外科器械100、480、500、600、1100、1150、1200中的任一者的所选轴的轴模块。轴模块可通过轴模块控制器1442在非易失性存储器1448中更换或升级,具体取决于要在操作中使用的外科器械轴。
图64示出了包括与本文结合图1至图61所述的外科器械100、480、500、600、1100、1150、1200中的任一者一起使用的反馈系统的外科器械1500的一个方面的示图,该外科器械可包括或实现本文所述的许多特征。例如,在一个方面,外科器械1500可类似于或代表外科器械100、480、500、600、1100、1150、1200中的任一者。外科器械1500可包括发生器1502。外科器械1500还可包括端部执行器1506,当临床医生操作触发器1510时,该端部执行器被激活。在各个方面,端部执行器1506可包括超声刀以递送超声振动,从而对活组织进行外科凝固/切割治疗。在其它方面,端部执行器1506可包括联接到电外科高频电流能量源的导电元件以对活组织进行外科凝固或烧灼治疗,并且包括具有尖锐边缘的机械刀或超声刀以对活组织进行切割治疗。当触发器1510被致动时,力传感器1512可生成指示施加到触发器1510的力的量的信号。除了力传感器1512之外或代替该力传感器,外科器械1500可包括位置传感器1513,其可生成指示触发器1510的位置(例如,触发器已被按压或以其它方式致动多远)的信号。在一个方面,位置传感器1513可为与上述外部管状护套一起定位的传感器或位于上述外部管状护套内的往复运动管状致动构件。在一个方面,传感器可为霍尔效应传感器或响应于磁场而改变其输出电压的任何合适的换能器。霍尔效应传感器可用于接近切换、定位、速度检测和电流感测应用。在一个方面,霍尔效应传感器作为模拟换能器操作,直接返回电压。在磁场已知的情况下,可确定其与霍尔板的距离。
控制电路1508可从传感器1512和/或1513接收信号。控制电路1508可包括任何合适的模拟或数字电路部件。控制电路1508还可与发生器1502和/或换能器1504通信,以基于施加到触发器1510的力和/或触发器1510的位置和/或上述外部管状护套相对于位于上述外部管状护套56内的往复运动管状致动构件58的位置(例如,通过霍尔效应传感器和磁体的组合测量)来调节递送到端部执行器1506的功率和/或端部执行器1506的发生器水平或超声刀振幅。例如,随着更大的力被施加到触发器1510,更大的功率和/或更高的超声刀振幅可被递送到端部执行器1506。根据各个方面,力传感器1512可由多位置开关代替。
根据各个方面,端部执行器1506可包括夹具或夹持机构,例如上文关于图1至图5所述的夹持机构。当触发器1510最初被致动时,夹持机构可闭合,同时夹持夹持臂与端部执行器1506之间的组织。随着施加到触发器的力增加(例如,通过力传感器1512感测),控制电路1508可增加由换能器1504递送到端部执行器1506的功率和/或在端部执行器1506中产生的发生器水平或超声刀振幅。在一个方面,控制电路1508可使用通过位置传感器1513感测的触发器位置或通过位置传感器1513(例如,利用霍尔效应传感器)感测的夹具或夹持臂位置来设定端部执行器1506的功率和/或振幅。例如,随着触发器进一步朝向完全致动位置移动,或者夹具或夹持臂进一步朝向超声刀(或端部执行器1506)移动,可增加端部执行器1506的功率和/或振幅。
根据各个方面,外科器械1500还可包括一个或多个反馈装置,用于指示递送到端部执行器1506的功率的量。例如,扬声器1514可发出指示端部执行器功率的信号。根据各个方面,扬声器1514可发出一系列脉冲声,其中这些声音的频率可指示功率。除了扬声器1514之外或代替该扬声器,外科器械1500可包括视觉显示器1516。视觉显示器1516可根据任何合适的方法指示端部执行器功率。例如,视觉显示器1516可包括一系列LED,其中端部执行器功率由照亮的LED的数目来指示。扬声器1514和/或视觉显示器1516可由控制电路1508驱动。根据各个方面,外科器械1500可包括连接到触发器1510的棘轮装置(未示出)。随着更大的力被施加到触发器1510,棘轮装置可生成听觉声音,从而提供端部执行器功率的间接指示。外科器械1500可包括可提高安全性的其它功能。例如,控制电路1508可被构造成能够防止超过预定阈值的功率被递送到端部执行器1506。而且,控制电路1508可在指示(例如,通过扬声器1514或视觉显示器1516)端部执行器功率变化的时间与递送端部执行器功率变化的时间之间实现延迟。这样,临床医生可获得充分的警告:要被递送到端部执行器1506的超声功率水平将改变。
在一个方面,本文结合图1至图61所述的外科器械100、480、500、600、1100、1150、1200中的任一者的超声或高频电流发生器可被构造成能够以数字方式产生电信号波形,使得能够以期望方式使用存储在查找表中的预定数目的相位点来数字化波形。相位点可存储在存储器、现场可编程门阵列(FPGA)或任何合适的非易失性存储器中定义的表中。图65示出了用于数字合成电路诸如直接数字合成(DDS)电路1600的基本架构的一个方面,该电路被构造成能够为电信号波形产生多个波形。发生器软件和数字控制器可命令FPGA扫描查找表1604中的地址,该查找表又向馈送功率放大器的DAC电路1608提供不同的数字输入值。可根据感兴趣的频率扫描地址。使用此类查找表1604使得能够产生各种类型的波形,这些波形可被馈送到组织中,或者被馈送到换能器、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,或被馈送到RF和超声器械的组合中。此外,可从发生器创建、存储表示多个波形的多个查找表1604,并将其从发生器施加到组织。
波形信号可被构造成能够控制超声换能器和/或RF电极或者多个超声换能器和/或RF电极(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个。此外,在外科器械包括超声部件的情况下,波形信号可被构造成能够驱动至少一个外科器械的超声换能器的至少两个振动模式。因此,发生器可被构造成能够向至少一个外科器械提供波形信号,其中该波形信号对应于表中的多个波形中的至少一个波形。此外,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。该表可包括与多个波形相关联的信息,并且该表可存储在发生器内。在一个方面或示例中,该表可为直接数字合成表,其可存储在发生器的FPGA中。该表可以便于对波形进行分类的任何方式进行寻址。根据一个方面,可为直接数字合成表的该表根据波形信号的频率进行寻址。另外,与多个波形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构造成能够控制超声换能器和/或RF电极或者多个超声换能器和/或RF电极(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个。此外,在外科器械包括超声部件的情况下,模拟电信号波形可被构造成能够驱动至少一个外科器械的超声换能器的至少两个振动模式。因此,发生器电路可被构造成能够向至少一个外科器械提供模拟电信号波形,其中模拟电信号波形对应于存储在查找表1604中的多个波形中的至少一个波形。此外,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。查找表1604可包括与多个波形相关联的信息,并且查找表1604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1604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1604可以便于对波形进行分类的任何方式进行寻址。根据一个方面,可为直接数字合成表的查找表1604根据所需模拟电信号波形的频率进行寻址。另外,与多个波形相关联的信息可作为数字信息存储在查找表1604中。
随着数字技术在器械和通信系统中的广泛使用,从参考频率源产生多个频率的数字控制方法已经逐步形成,被称为直接数字合成。基本架构在图65中示出。在该简化框图中,DDS电路联接到处理器、控制器或发生器电路的逻辑装置,并且联接到位于本文结合图1至图61所述的外科器械100、480、500、600、1100、1150、1200中的任一者的发生器电路中的存储器电路。DDS电路1600包括地址计数器1602、查找表1604、寄存器1606、DAC电路1608和滤波器1612。地址计数器1602接收稳定的时钟fc并且寄存器1606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)的一个或多个整数周期存储在查找表1604中。随着地址计数器1602逐步通过存储器位置,存储在查找表1604中的值被写入联接到DAC电路1608的寄存器1606。查找表1604的存储器位置处信号的相应数字幅度驱动DAC电路1608,该DAC电路又生成模拟输出信号1610。模拟输出信号1610的频谱纯度主要由DAC电路1608确定。相位噪声基本上是参考时钟fc的相位噪声。从DAC电路1608输出的第一模拟输出信号1610由滤波器1612进行滤波,并且由滤波器1612输出的第二模拟输出信号1614被提供给放大器,该放大器具有联接到发生器电路的输出端的输出。第二模拟输出信号具有频率f
因为DDS电路1600是采样数据系统,所以必须考虑采样中涉及的问题:量化噪声、混叠、滤波等。例如,DAC电路1608输出频率的高阶谐波折回到奈奎斯特带宽中,使得它们不可进行滤波,但是可对基于锁相环(PLL)的合成器的输出的高阶谐波进行滤波。查找表1604包含整数个周期的信号数据。通过改变参考时钟频率fc或重新编程PROM可改变最终输出频率f
DDS电路1600可包括多个查找表1604,其中查找表1604存储由预定数目的样本表示的波形,其中样本定义波形的预定形状。因此,具有独特形状的多个波形可存储在多个查找表1604中,以基于器械设置或组织反馈提供不同的组织治疗。波形的示例包括用于表面组织凝固的高波峰因数RF电信号波形、用于更深组织穿透的低波峰因数RF电信号波形以及促进有效修正凝固的电信号波形。在一个方面,DDS电路1600可创建多个波形查找表1604,并且在组织治疗规程期间基于期望的组织效果和/或组织反馈(例如,“在运行中”或者基于用户或传感器输入虚拟实时地)在单独的查找表1604中存储的不同波形之间切换。因此,例如波形之间的切换可基于组织阻抗和其它因素进行。在其它方面,查找表1604可存储被成形为使每个周期递送到组织中的功率最大化的电信号波形(即,梯形波或方波)。在其它方面,查找表1604可存储以如下方式同步的波形:使得当递送RF和超声驱动信号时,它们通过本文结合图1至图61所述的外科器械100、480、500、600、1100、1150、1200中的任一者的多功能外科器械使功率递送最大化。在其它方面,查找表1604可存储电信号波形,以在保持超声频率锁定时同时驱动超声和RF治疗能量和/或亚治疗能量。特定于不同器械及其组织效果的定制波形可存储在发生器电路的非易失性存储器中或者本文结合图1至图61所述的外科器械100、480、500、600、1100、1150、1200中的任一者的非易失性存储器(例如,EEPROM)中,并且可在将多功能外科器械连接到发生器电路时获取。如许多高波峰因数“凝固”波形中所用的指数衰减正弦曲线的一个示例在图67中示出。
DDS电路1600的更灵活和更有效的实现方式采用称为数控振荡器(NCO)的数字电路。更灵活和更有效的数字合成电路诸如DDS电路1700的框图在图66中示出。在该简化框图中,DDS电路1700联接到处理器、控制器或发生器的逻辑装置,并且联接到位于发生器中或本文结合图1至图61所述的外科器械100、480、500、600、1100、1150、1200中的任一者中的存储器电路。DDS电路1700包括负载寄存器1702、并行Δ相位寄存器1704、加法器电路1716、相位寄存器1708、查找表1710(相幅转换器)、DAC电路1712和滤波器1714。加法器电路1716和相位寄存器1708a形成相位累加器1706的一部分。时钟信号fc被施加到相位寄存器1708和DAC电路1712。负载寄存器1702接收将输出频率指定为参考时钟频率fc的一部分的调谐字。负载寄存器1702的输出利用调谐字M被提供给并行Δ相位寄存器1704。
DDS电路1700包括生成时钟频率fc的采样时钟、相位累加器1706和查找表1710(例如,相幅转换器)。每个时钟周期fc更新一次相位累加器1706的内容。当相位累加器1706被更新时,存储在并行Δ相位寄存器1704中的数字值M被加法器电路1716加到相位寄存器1708中的数字上。假设并行Δ相位寄存器1704中的数字是00……01并且相位累加器1706的初始内容是00……00。相位累加器1706每个时钟周期更新00……01。如果相位累加器1706为32位宽,则在相位累加器1706返回到00……00之前需要232个时钟周期(超过40亿),并且该周期重复。
相位累加器1706的截断输出1718被提供给相幅转换器查找表1710,并且查找表1710的输出联接到DAC电路1712。相位累加器1706的截断输出1718用作正弦(或余弦)查找表的地址。查找表中的地址对应于正弦波上从0°到360°的相位点。查找表1710包含正弦波的一个完整周期的相应数字幅度信息。因此,查找表1710将来自相位累加器1706的相位信息映射到数字幅度字,该数字幅度字又驱动DAC电路1712。DAC电路的输出是第一模拟信号1720并由滤波器1714进行滤波。滤波器1714的输出是第二模拟信号1722,该第二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,但是波形可被数字化为任何合适数目的2n个相位点,范围从256(28)到281、474、976、710、656(248),其中n是正整数,如表1所示。电信号波形可表示为An(θn),其中点n处的归一化幅度An由相位角θn(称为点n处的相位点)表示。离散相位点的数目n确定DDS电路1700(以及图65所示的DDS电路1600)的调谐分辨率。
N 相位点的数目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1710中的地址,该查找表又向馈送滤波器1714和功率放大器的DAC电路1712提供不同的数字输入值。可根据感兴趣的频率扫描地址。使用查找表使得能够产生各种类型的形状,这些形状可通过DAC电路1712转换成模拟输出信号、通过滤波器1714进行滤波、通过联接到发生器电路的输出端的功率放大器进行放大,并且以RF能量的形式被馈送到组织或者以超声振动(以热量的形式向组织递送能量)的形式被馈送到超声换能器并被施加到组织。例如,放大器的输出可应用于RF电极、同时应用于多个RF电极、应用于超声换能器、同时应用于多个超声换能器,或者应用于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,并将其从发生器电路施加到组织。
重新参考图65,对于n=32并且M=1,相位累加器1706在其溢出和重启之前逐步通过232个可能的输出。相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很快“翻转”两倍,并且输出频率加倍。这可概括如下:
对于被构造成能够累加n位(在大多数DDS系统中,n通常在24至32的范围内,但是如前所述,n可从范围更广的选项中选择)的相位累加器1706,存在2n个可能的相位点。Δ相位寄存器中的数字M表示每个时钟周期相位累加器增加的量。如果fc为时钟频率,则输出正弦波的频率等于:
Figure BDA0001767737420000851
公式1被称为DDS“调谐公式”。应当注意,系统的频率分辨率等于
Figure BDA0001767737420000852
对于n=32,分辨率大于40亿分之一。在DDS电路1700的一个方面,并非相位累加器1706中的所有位都被传递到查找表1710,而是被截断,例如仅留下前13至15个最有效的位(MSB)。这减小了查找表1710的大小但不会影响频率分辨率。相位截断仅向最终输出添加少量但可接受的相位噪声量。
电信号波形的特征可通过预定频率下的电流、电压或功率来表征。此外,在本文结合图1至图61所述的外科器械100、480、500、600、1100、1150、1200中的任一者包括超声部件的情况下,电信号波形可被构造成能够驱动至少一个外科器械的超声换能器的至少两个振动模式。因此,发生器电路可被构造成能够向至少一个外科器械提供电信号波形,其中电信号波形可通过存储在查找表1710(或图65的查找表1604)中的预定波形来表征。此外,电信号波形可为两个或更多个波形的组合。查找表1710可包括与多个波形相关联的信息。在一个方面或示例中,查找表1710可由DDS电路1700生成,并且可被称为直接数字合成表。DDS首先将大型重复波形存储在板载存储器中。波形(正弦波、三角波、方波、任意波)的周期可由如表1所示的预定数目的相位点表示,并且存储在存储器中。一旦波形存储在存储器中,就可以非常精确的频率生成波形。直接数字合成表可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1710可通过便于对波形进行分类的任何合适的技术进行寻址。根据一个方面,查找表1710根据电信号波形的频率进行寻址。另外,与多个波形相关联的信息可作为数字信息存储在存储器中或作为查找表1710的一部分。
在一个方面,发生器电路可被构造成能够同时向至少两个外科器械提供电信号波形。发生器电路还可被构造成能够经由发生器电路的输出通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/或其组合。另外,电信号波形可包括多个超声驱动信号、多个RF驱动信号和/或多个超声和RF驱动信号的组合。
另外,根据本公开操作发生器电路的方法包括产生电信号波形并将所产生的电信号波形提供给本文结合图1至图61所述的外科器械100、480、500、600、1100、1150、1200中的任一者,其中产生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。所产生的电信号波形包括至少一个波形。此外,将所产生的电信号波形提供给至少一个外科器械包括同时向至少两个外科器械提供电信号波形。
本文所述的发生器电路可允许产生各种类型的直接数字合成表。发生器电路所产生的且适用于治疗各种组织的RF/电外科信号的波形的示例包括具有高波峰因数的RF信号(其可用于RF模式中的表面凝固)、低波峰因数RF信号(其中可用于更深的组织穿透)以及促进有效修正凝固的波形。生成器电路还可使用直接数字合成查找表1710产生多个波形,并且在运行中可基于期望的组织效果在特定波形之间切换。切换可基于组织阻抗和/或其它因素进行。
除了传统的正弦/余弦波形之外,发生器电路可被构造成能够产生使每个周期到组织中的功率最大化的波形(即,梯形波或方波)。发生器电路可提供同步的波形,以在同时驱动RF和超声信号时最大化递送到负载的功率并且保持超声频率锁定,前提条件是发生器电路包括能够同时驱动RF和超声信号的电路拓扑结构。此外,特定于器械及其组织效果的定制波形可存储在非易失性存储器(NVM)或器械EEPROM中,并且可在将本文结合图1至图61所述的外科器械100、480、500、600、1100、1150、1200中的任一者连接到发生器电路时获取。
DDS电路1700可包括多个查找表1604,其中查找表1710存储由预定数目的相位点(也可称为样本)表示的波形,其中相位点定义波形的预定形状。因此,具有独特形状的多个波形可存储在多个查找表1710中,以基于器械设置或组织反馈提供不同的组织治疗。波形的示例包括用于表面组织凝固的高波峰因数RF电信号波形、用于更深组织穿透的低波峰因数RF电信号波形以及促进有效修正凝固的电信号波形。在一个方面,DDS电路1700可创建多个波形查找表1710,并且在组织治疗规程期间基于期望的组织效果和/或组织反馈(例如,“在运行中”或者基于用户或传感器输入虚拟实时地)在不同的查找表1710中存储的不同波形之间切换。因此,例如波形之间的切换可基于组织阻抗和其它因素进行。在其它方面,查找表1710可存储被成形为使每个周期递送到组织中的功率最大化的电信号波形(即,梯形波或方波)。在其它方面,查找表1710可存储以如下方式同步的波形:使得当递送RF和超声驱动信号时,它们通过本文结合图1至图61所述的外科器械100、480、500、600、1100、1150、1200中的任一者使功率递送最大化。在其它方面,查找表1710可存储电信号波形,以在保持超声频率锁定时同时驱动超声和RF治疗能量和/或亚治疗能量。通常,输出波形可为正弦波、余弦波、脉冲波、方波等形式。特定于不同器械及其组织效果的更复杂定制波形可存储在发生器电路的非易失性存储器中或者外科器械的非易失性存储器(例如,EEPROM)中,并且可在将外科器械连接到发生器电路时获取。定制波形的一个示例是如许多高波峰因数“凝固”波形中所用的指数衰减正弦曲线,如图67所示。
图67示出了根据模拟波形1804(出于比较目的,被示出叠加在离散时间数字电信号波形1800上)的本公开的一个方面的离散时间数字电信号波形1800的一个周期。水平轴表示时间(t),并且垂直轴表示数字相位点。例如,数字电信号波形1800是期望模拟波形1804的数字离散时间型式。通过存储幅度相位点1802来产生数字电信号波形1800,该幅度相位点表示在一个周期To内每个时钟周期Tclk的幅度。通过任何合适的数字处理电路在一个周期To内产生数字电信号波形1800。幅度相位点是存储在存储器电路中的数字。在图65和图66所示的示例中,数字是能够以26或64位的分辨率存储幅度相位点的六位字。应当理解,图65和图66所示的示例是出于例示性目的,并且在实际实现方式中分辨率可高得多。一个周期To内的数字幅度相位点1802作为一串字符串字存储在存储器中,例如存储在结合图65、图66所述的查找表1604、1710中。为了产生模拟波形1804的模拟型式,从存储器中相继读取每个时钟周期Tclk从0至To的幅度相位点1802,并且通过同样结合图65、图66所述的DAC电路1608、1712对这些相位点进行转换。通过重复读取从0至To的数字电信号波形1800的幅度相位点1802,持续可能需要的尽可能多个周期,可产生额外的周期。通过滤波器1612、1714(图65和图66)对DAC电路1608、1712的输出进行滤波来实现模拟波形1804的平滑模拟型式。经滤波的模拟输出信号1614、1722(图65和图66)被施加到功率放大器的输入端。
在一个方面,如图68A所示,电路1900可包括控制器,该控制器包括联接到至少一个存储器电路1904的一个或多个处理器1902(例如,微处理器、微控制器)。至少一个存储器电路1904存储机器可执行指令,所述机器可执行指令在由处理器1902执行时使处理器1902执行机器指令,以实现本文所述的任何算法、过程或技术。
处理器1902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1904可包括易失性和非易失性存储介质。在一个方面,如图68A所示,处理器1902可包括指令处理单元1906和运算单元1908。指令处理单元可被构造成能够从一个存储器电路1904接收指令。
在一个方面,电路1910可包括有限状态机,该有限状态机包括如图68B所示的组合逻辑电路1912,该组合逻辑电路被构造成能够实现本文所述的任何算法、过程或技术。在一个方面,电路1920可包括有限状态机,该有限状态机包括如图68C所示的时序逻辑电路。例如,时序逻辑电路1920可包括组合逻辑电路1912和至少一个存储器电路1914。至少一个存储器电路1914可存储有限状态机的当前状态,如图68C所示。时序逻辑电路1920或组合逻辑电路1912可被构造成能够实现本文所述的任何算法、过程或技术。在某些情况下,时序逻辑电路1920可为同步的或异步的。
在其它方面,该电路可包括处理器1902和有限状态机的组合,以实现本文所述的任何算法、过程或技术。在其它方面,有限状态机可包括组合逻辑电路1910和时序逻辑电路1920的组合。
图69为根据本公开的一个方面的具有马达控制功能的外科器械的各种部件的电路1925的示意图。在各个方面,本文结合图1至图68C所述的外科器械100、480、500、600、1100、1150、1200可包括驱动机构1930,该驱动机构被构造成能够驱动轴和/或齿轮部件,以便执行与外科器械100、480、500、600、1100、1150、1200相关联的各种操作。在一个方面,驱动机构1930包括旋转传动系1932,该旋转传动系被构造成能够使结合例如图1、图20、图40、图41、图45、图54所述的端部执行器112、512、1000、1112、1212相对于柄部外壳围绕纵向轴线旋转。驱动机构1930还包括闭合传动系1934,该闭合传动系被构造成能够闭合钳口构件以用端部执行器抓持组织。另外,驱动机构1930包括击发传动系1936,该击发传动系被构造成能够击发端部执行器的I形梁刀以切割由端部执行器抓持的组织。
驱动机构1930包括选择器齿轮箱组件1938,该选择器齿轮箱组件可位于外科器械的柄部组件中。选择器齿轮箱组件1938的近侧是功能选择模块,该功能选择模块包括第一马达1942,该第一马达用于选择性地移动选择器齿轮箱组件1938内的齿轮元件,以选择性地将传动系1932、1934、1936中的一者定位成与任选的第二马达1944和马达驱动电路1946(以虚线示出,以表示第二马达1944和马达驱动电路1946是任选部件)的输入驱动部件接合。
仍然参考图69,马达1942、1944分别联接到马达控制电路1946、1948,这些马达控制电路被构造成能够控制马达1942、1944的操作,包括电能从功率源1950到马达1942、1944的流动。功率源1950可为DC电池(例如,可充电铅基、镍基、锂离子基电池等)或适用于向外科器械提供电能的任何其它功率源。
外科器械还包括微控制器1952(“控制器”)。在某些情况下,控制器1952可包括微处理器1954(“处理器”)和一个或多个计算机可读介质或存储单元1956(“存储器”)。在某些情况下,存储器1956可存储各种程序指令,这些程序指令在执行时可使处理器1954执行本文所述的多个功能和/或计算。例如,功率源1950可被构造成能够向控制器1952供电。
处理器1954与马达控制电路1946通信。另外,存储器1956可存储程序指令,这些程序指令在由处理器1954响应于用户输入1958或反馈元件1960执行时可使马达控制电路1946促动马达1942产生至少一种旋转运动,以选择性地移动选择器齿轮箱组件1938内的齿轮元件,从而选择性地将传动系1932、1934、1936中的一者定位成与第二马达1944的输入驱动部件接合。此外,处理器1954可与马达控制电路1948通信。存储器1956还可存储程序指令,这些程序指令在由处理器1954响应于用户输入1958执行时可使马达控制电路1948促动马达1944产生至少一种旋转运动,以驱动例如与第二马达1948的输入驱动部件接合的传动系。
控制器1952和/或本公开的其它控制器可使用集成和/或分立硬件元件、软件元件和/或两者的组合来实现。集成硬件元件的示例可包括处理器、微处理器、微控制器、集成电路、ASIC、PLD、DSP、FPGA、逻辑门、寄存器、半导体器件、芯片、微芯片、芯片组、微控制器、片上系统(SoC)和/或单列直插式封装(SIP)。分立硬件元件的示例可包括电路和/或电路元件,诸如逻辑门、场效应晶体管、双极型晶体管、电阻器、电容器、电感器和/或继电器。在某些情况下,控制器1952可包括例如混合电路,该混合电路在一个或多个基板上包括分立和集成电路元件或部件。
在某些情况下,控制器1952和/或本公开的其它控制器可为例如可购自TexasInstruments的LM 4F230H5QR。在某些情况下,Texas Instruments LM4F230H5QR是ARMCortex-M4F处理器芯,其包括高达40MHZ的256KB单周期闪速存储器或其它非易失性存储器的芯片上存储器、40MHz以上的用于提高性能的预取缓冲区、32KB单周期SRAM、加载有
Figure BDA0001767737420000901
软件的内置ROM、2KB EEPROM、一个或多个PWM模块、一个或多个QEI模拟、一个或多个具有12个模拟输入通道的12位ADC,以及易得的其它特征结构。可以很方便地换用其它微控制器,来与本公开联合使用。因此,本公开不应限于这一上下文。
在各种情况下,本文所述的各个步骤中的一个或多个可由包括组合逻辑电路或时序逻辑电路的有限状态机执行,其中组合逻辑电路或时序逻辑电路联接到至少一个存储器电路。至少一个存储器电路存储有限状态机的当前状态。组合或时序逻辑电路被构造成能够使有限状态机到达各个步骤。时序逻辑电路可为同步的或异步的。在其它情况下,例如可通过包括处理器1958和有限状态机的组合的电路来执行本文所述的各个步骤中的一个或多个。
在各种情况下,能够评估外科器械的功能状态以确保其正常功能可能是有利的。这对于例如如上所述的驱动机构(被构造成能够包括各种马达、传动系和/或齿轮部件,以便执行外科器械的各种操作)随着时间推移被磨损是可能的。这可通过正常使用发生,并且在一些情况下,由于滥用状况,驱动机构可能磨损得更快。在某些情况下,外科器械可被构造成能够执行自我评估,以确定驱动机构及其各种部件的状态,例如健康状况。
例如,自我评估可用于确定外科器械在再次灭菌之前何时能够执行其功能或何时应当更换和/或修复一些部件。可以各种方式实现对驱动机构及其部件(包括但不限于旋转传动系1932、闭合传动系1934和/或击发传动系1936)的评估。偏离预测性能的大小可用于确定所感测的故障的可能性和此类故障的严重性。可使用多个度量,包括:可重复预测事件的周期性分析、超出预期阈值的峰值或降值以及故障的宽度。
在各种情况下,可采用正常运行的驱动机构或者其一个或多个部件的特征波形来评估驱动机构或者其一个或多个部件的状态。一个或多个振动传感器可相对于正常运行的驱动机构或者其一个或多个部件布置,以记录在正常运行的驱动机构或者其一个或多个部件的操作期间发生的各种振动。所记录的振动可用于创建特征波形。可将未来波形与特征波形进行比较,以评估驱动机构及其部件的状态。
仍然参考图69,外科器械1930包括传动系故障检测模块1962,该模块被构造成能够记录和分析一个或多个传动系1932、1934、1936的一个或多个声学输出。处理器1954可与模块1962通信或以其它方式控制该模块。如下文更详细地描述,模块1962可被实施为各种装置,诸如电路、硬件、计算机程序产品(其包括计算机可读介质(例如,存储器1956),该计算机可读介质存储可由处理装置(例如,处理器1954)执行的计算机可读程序指令)或其某种组合。在一些方面,处理器36可包括模块1962或以其它方式控制该模块。
图70示出了根据本公开的一个方面的柄部组件1970,其中可移除维修板1972被移除以示出柄部组件的内部部件。可移除维修板1972或可移除维修盖还包括用于强度的增强肋1990。可移除维修板1972包括多个紧固件1988,这些紧固件与柄部外壳1974上的多个紧固件1986配合,以将可移除维修板1972可移除地附接到柄部外壳1974。在一个方面,可移除维修板1972中的紧固件1988包括第一组磁体,并且柄部外壳1974包括第二组磁体,第二组磁体将维修板1972磁性地锁定到柄部外壳1974上。在一个方面,第一组磁体6112a和第二组磁体6112b是稀土永磁体。
在图70中,可移除维修板1972被示出从柄部外壳1974移除,以示出外科器械的电子部件和机械部件诸如马达1976和电接触件1984的位置,从而将电池组件或柔性电路电联接到柄部外壳1974。马达1976和电接触件1984也可从柄部外壳1974移除。柄部组件1970还包括触发器1982和致动开关1980,该触发器和致动开关各自可从柄部外壳1974移除。如前所述,可移除触发器1982可具有多个操作阶段以闭合钳口构件、击发刀、激活超声换能器、激活高频电流和/或打开钳口构件。致动开关1980可用多个开关代替,以激活不同的功能,诸如闭合钳口构件、击发刀、激活超声换能器、激活高频电流和/或打开钳口构件。如图70所示,柄部组件1970包括电接触件1978,以将柄部组件1970电联接到轴组件,其中电接触件1978可从柄部外壳1974移除。柄部外壳1974还限定用于接收可移除超声换能器组件、超声换能器、超声换能器驱动电路、高频电流驱动电路和/或显示组件的空间,如前所述。
图71至图75示出了本公开的各个方面,本公开涉及细长轴,该细长轴具有沿移动轴组件部件的内侧并且沿移动轴部件的外侧的单独路径并入的控制和感测电子器件,用于本文结合图1至图70描述的外科器械100、480、500、600、1100、1150、1200中的任何一个。沿轴组件的长度设置的磁位置传感器以不同构型组对,允许多个传感器检测联接到轴运动(例如,关节运动、端部执行器旋转、钳口构件打开/闭合)的单个磁体,以确定致动部件相对于固定参考平面的三维位置,并同时诊断外部来源产生的任何错误。
本公开的方面呈现用于被构造成能够使用一系列磁体和传感器检测各种部件的三维位置和位置变化的系统和外科器械。在一些方面,一种外科器械包括柄部组件、联接到该柄部组件的轴,以及联接到该轴的远侧端部的端部执行器。多个磁体可以固定地联接到轴,而多个传感器也可联接到该轴并且被构造成能够确定远离多个磁体中的每一个的距离。轴可被构造成能够移动,诸如旋转、平移和/或围绕关节运动接头进行关节运动。磁体可联接到轴,使得磁体在轴移动时以相同方式移动。然而,传感器可连接到轴,使得传感器在轴移动时保持在固定位置。例如,轴可包括外轴和内轴,诸如主旋转驱动器,并且外轴可被构造成能够在主旋转驱动器不移动时移动。磁体可附连到外轴,并且传感器可附连到主旋转驱动器或其中的一部分。传感器可检测在轴移动时三个或更多个磁体的距离的变化,例如其可由处理器处理以确定轴的三维位置的变化。传感器的数据可经由在主旋转驱动器内部运行的柔性电路发送至处理器。
在一些方面,一系列传感器和磁体的一部分可被构造成能够检测端部执行器的平移或其它运动。例如,端部执行器可包括一对钳口,其中钳口中的至少一个被构造成能够通过联接到主旋转驱动器的一部分的夹持臂而打开和闭合。夹持臂可最终通信地联接到柄部组件的被配置成操纵端部执行器的一部分,诸如柄部或触发器。拉动柄部组件的触发器可导致钳口中的一个或多个在端部执行器处打开或闭合。磁体中的一个或多个可附连到夹持臂的当夹持臂被操纵时移动的一部分。传感器中的一个或多个可附连到轴的在端部执行器附近的在夹持臂被操纵时不移动的一部分。因此,传感器可被构造成能够检测在夹持臂被操纵时这些磁体的距离的变化,其可由处理器进行处理以确定端部执行器的钳口的运动的变化。传感器的数据可经由在主旋转驱动器内部运行的柔性电路发送至处理器。
在一些方面,所述系统和外科器械还可被构造成能够使用一系列磁体和传感器来确定外科器械的误差状况。例如,如果检测到磁体的移动超过基于传感器中的一个或多个的检测的已知公差或阈值,则可生成误差状况。例如,所述外科器械的轴可被构造成能够只旋转到这么远,并且如果传感器检测到一个或多个磁体的位置变化超过了已知旋转或角度,则可生成误差状况。又如,可监测多个磁体的位置,并且如果计算出磁体的位置中的一个与其它磁体的计算位置不一致,则可生成误差状况。
参见图71,图示5100示出了根据各个方面的在医疗装置的柄部组件和轴组件的一部分内部互连的轴控制电子器件的示例系统,所述医疗装置诸如本文结合图1至图70所述的外科器械100、480、500、600、1100、1150、1200中的任一个。模块5102示出了根据一些方面的柄部组件的内部工作的一部分,其联接到包括轴组件的部分的模块5104。模块5102包括柔性电路5106,该柔性电路穿过柄部组件的一部分并进入轴组件。更具体地讲,在一些方面,柔性电路5106穿过主旋转驱动器5108。主旋转驱动器5108被构造成能够驱动轴组件的至少一部分的旋转。虽然主旋转驱动器5108连续地穿过柄部组件的一部分和轴组件的近侧端部,但在该图示中,为了露出内部柔性电路5106,未示出主旋转驱动器的一部分。
柔性电路5106的近侧端部可以联接到电触点5110,该电触点接触柄部处的电触点5112。主旋转驱动器5108的齿轮5138可联接到柄部组件中的由柄部5136驱动的旋转齿轮5140。例如,电触点5110和触点电极5112将传感器5126、5128、5130电联接到控制电路,诸如控制电路210(图14)、300(图15)、1300(图62)、1400(图63)、1500(图64)、1900(图68A)、1910(图68B)、1920(图68C)、1954(图70)。
轴组件5104的远侧端部可联接到端部执行器,该端部执行器可以包括在连接器5134处以机械的方式和电的方式联接的一个或多个钳口。柔性电路5106可被构造成能够经由连接器5134将电信号发送到端部执行器。
仍然参考轴组件5104,根据一些方面,主旋转驱动器5108可以放置在外轴5114内。主旋转驱动器5108可被构造成能够使外轴5114在柔性电路5106保持固定时旋转。在一些方面,轴组件5104还可包括外轴5116的远侧件,其经由关节运动接头5118联接到近侧外轴5114。虽然主旋转驱动器5108可以仅穿过近侧外轴5114的端部,但是柔性电路5106可以穿过远侧外轴5116,并且可以被构造成能够当外轴5116围绕关节运动接头5118进行关节运动时进行关节运动并弯曲。
在一些方面,轴组件5104的外轴部分可包括一个或多个磁体,诸如磁体5120、5122、5124。这些磁体可以附连到外轴部分,因此可以在外轴部分移动或改变位置时移动或改变位置。同时,柔性电路5106可包括一个或多个传感器,这些传感器被构造成能够测量远离一个或多个磁体的距离,诸如传感器5126、5128、5130。霍尔效应传感器是被构造成能够测量远离一个或多个磁体的距离的示例类型的传感器。如图所示,轴组件5104可包括彼此紧邻的多组传感器-磁体对,诸如紧邻磁体5120的传感器5126,紧邻磁体5122的传感器5128,以及紧邻磁体5124的传感器5130。该构型可以允许传感器仅测量距非常近的那些磁体的距离。
在一些方面,轴组件5104还可包括平移轴部分,诸如轴部分5132,其被构造成能够在轴组件5104的远侧端部处来回滑动。磁体5124可以被构造成能够与轴部分5132一起平移或滑动,而传感器5130在其附接到柔性电路5106时保持固定。
在一些方面,传感器-磁体对中的一个或多个可被构造成能够测量轴组件5104的旋转程度。例如,当磁体5120与外轴5114一起旋转时,可测量远离传感器5126的距离的变化。基于距离或距离随时间的变化,可以确定外轴5114旋转了多少。
类似地,在一些方面,传感器-磁体对中的一个或多个可被构造成能够测量轴组件5104的关节运动程度。例如,当磁体5122与远侧外轴部分5116一起围绕关节运动接头5118进行关节运动时,传感器5128可以被构造成能够测量到磁体5122的距离。由于传感器5128的放置略微远离关节运动接头5118的中心,所以远离磁体5122的距离将随着远侧外轴5116进行关节运动而变化。基于距离或距离随时间的变化,可以确定远侧外轴116如何围绕关节运动接头5118进行关节运动。
此外,在一些方面,传感器-磁体对中的一个或多个可被构造成能够测量轴组件5104的平移量。例如,当磁体5124与轴5132的平移部分一起平移时,传感器5130可以被构造成能够测量远离磁体5124的距离。基于距离或距离随时间的变化,可以确定轴组件远离传感器5130平移了多少。
在一些方面,可以将根据本文所述的技术计算处的位置或位置变化与预定公差进行比较。例如,医疗装置的柄部组件内的微处理器和存储器可具有距离或公差表,其反映轴组件的各个部件的最大移动范围。如果计算出磁体中的一个或多个超过该表中的一个值,则可以设置可以激活警报的误差状况。
在一些方面,这些技术中的任何一种或全部可以包括在医疗装置中以测量并监测轴组件的位置变化。图示5100仅提供了磁体和传感器可以定位在何处的一些示例,但是对于本领域普通技术人员来说,可以容易地看出磁体和传感器可以如何定位以实现类似的效果,并且各方面不受这样的限制。
参见图72,图示5100提供了根据一些方面的柔性电路5106的放大部分的示例。如图所示,该柔性电路可包括一系列基底层5202。这些层可以足够柔韧以弯曲和扭曲。如图所示,霍尔效应传感器5204和5206或被构造成能够测量磁体强度的其它类型的传感器可以附连到柔性电路5106。
参见图73A和图73B,在一些方面,多个传感器可以根据一些方面组合使用以测量和监测医疗装置的运动。例如,如图73A的图示5160所示,轴组件的一部分的横剖视图示出了包括一个磁体5164的外轴5162。内轴5166可包括柔性电路5174。柔性电路5174可包括三个传感器5168、5170和5172,其定位在远离磁体5164的不同距离处。外轴部分5162可以被构造成能够在内轴5166或其至少一部分可以固定时旋转。
参见图73B,图示5180示出了外轴的旋转运动。如图所示,磁体5164与外轴5162一起旋转。箭头5182指示相对于中心线5176的旋转角度。因为三个传感器5168、5170和5172被定位在远离磁体5164的不同距离处,所以可以使用到磁体5164的三个不同距离来进行三边测量计算,以更明确地确定磁体5164在旋转时的位置。基于计算处的位置,可以确定外轴5162的旋转程度或角度。
通常,利用三个或更多个传感器,可以确定磁体的三维位置,假设这三个或更多个传感器定位在远离待测磁体的独特的不同距离处。因此,图示5100和5180中所示的原理可用于测量其它类型的位置变化,诸如平移距离或关节运动角度。
在一些方面,作为多个传感器的替代或补充,多个磁体可以附连到轴组件的移动部分,并且这一个或多个传感器可以被构造成能够测量多个磁体的多个距离以那样确定三维位置。
参见图74,图示5190提供了根据一些方面的多个传感器可如何用于确定一个或多个磁体的三维位置的另一示例。在该示例中,轴组件包括围绕关节运动接头5198的两个部件。两个传感器即5192和5194沿关节运动接头5198一侧上的柔性电路5199定位。在另一侧上是磁体5196,其被构造成能够当其围绕关节运动接头5198进行关节运动时与轴组件的该部分一起移动。这两个传感器5192和5194可足以确定磁体5196的独特三维位置,因为磁体5196的运动范围仅限于仅保留在多个传感器的一侧上的一个运动平面。通常,足以确定明确位置或位置变化的传感器或磁体的数目可以基于磁体中的传感器定位在何处,以及各个部件可移动多少自由度。
在一些方面,传感器和/或磁体可以定位成不同构型。位置传感器和磁体的间距允许与位置相关联的更高分辨率。例如,相对侧上的传感器可以在不同时间感测同一磁体,或者不同的磁体将与沿行程不同位置处的传感器相互作用。此外,可以通过磁体的图案实现更高的分辨率。例如,磁体可以间隔开,使得在一侧上快速连续地感测两个磁体,然后另一侧上的另一组表示与在一侧上合二为一不同的位置,接着是另一侧上的多个磁体。这可减少实现该效果所需的磁体或传感器的数目。
参见图75,图示5200示出了根据一些方面的医疗装置的轴组件的变型,该医疗装置包括用于保护敏感电子器件的密封件。在该情况下,外轴5202包括至少两个内部管状结构。旋转驱动器5204仍然存在并被外轴包封。其内是具有凸缘5208的管5206,诸如具有凸缘的橡胶管。凸缘5208可被构造成能够压靠旋转轴5204的内表面以形成密封件。该密封件可为气密的和不透水的。然后,管5206可以容纳对液体或其它暴露敏感的电子器件和其它材料,诸如柔性电路5210。
本文所公开的装置的方面可被设计为单次使用后丢弃,或者它们可被设计为多次使用。在任一种或两种情况下,可对各个方面进行修复以在使用至少一次之后重复使用。修复可包括以下步骤的任何组合:拆卸装置,然后清洁或替换特定零件以及随后进行重新组装。具体地讲,可拆卸所述装置的各方面,并且可选择性地以任何组合形式来更换或拆除所述装置的任何数目的特定部件或零件。清洁和/或更换具体部件后,可在修复设施中对装置的各方面进行重新组装,或在即将进行外科规程前由手术团队对其进行重新组装,以供随后使用。本领域的技术人员将会了解,装置的修复可利用多种技术进行拆卸、清洁/更换、以及重新组装。此类技术的使用以及所得的修复装置均在本申请的范围内。
仅以举例的方式,可在手术之前对本文所述的方面进行处理。首先,可以获得新的或用过的器械,并且根据需要进行清洁。然后,可对器械进行消毒。在一种灭菌技术中,将所述器械放置在密闭且密封的容器(诸如,塑料或TYVEK袋)中。然后可将容器和器械置于可穿透所述容器的辐射场,例如γ辐射、X射线或高能电子。辐射可以杀死器械上和容器中的细菌。消毒后的器械随后可被存放在无菌容器中。密封容器可将器械保持处于无菌状态,直至在医疗设施中将该容器打开。还可使用本领域已知的任何其它技术对装置进行消毒,所述技术包括但不限于β辐射或γ辐射、环氧乙烷或蒸汽。
虽然上述具体实施方式已经列出各种细节,但是应当理解,用于操作发生器以数字地产生电信号波形的技术和外科器械的各个方面可在没有这些具体细节的情况下实施。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,并且可以设想各种构型修改形式。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。
此外,虽然已经示出和描述了多种形式,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,可实现这些形式的许多修改、变型、更改、取代、组合和等同物,并且本领域的技术人员将想到这些形式的许多修改、变型、更改、取代、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具。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落入所公开形式的范围内的所有此类修改、组合和变型。所附权利要求旨在涵盖所有此类修改、变型、更改、取代、修改和等同物。
为了使公开内容简洁和清楚,已经以框图形式而不是详细地示出了前述公开内容的所选方面。本文提供的具体实施方式的一些部分可根据对存储在一个或多个计算机存储器或者一个或多个数据存储装置(例如,软盘、硬盘驱动器、光盘(CD)、数字视频光盘(DVD)或数字磁带)中的数据进行操作的指令来呈现。本领域的技术人员用此类描述和表达向本领域的其它技术人员描述和传达它们的工作要旨。通常,算法是指获得所需结果的步骤的自洽序列,其中“步骤”是指物理量和/或逻辑状态的操纵,物理量和/或逻辑状态可(但不一定)采用能够被存储、转移、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。这些术语和类似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/或状态的方便标签。
除非上述公开内容中另外明确指明,否则可以理解的是,在上述公开内容中,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它此类信息存储、传输或显示设备内的物理量的其它数据。
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,调制解调器、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/或示例阐述了装置和/或方法的各种形式。只要此类框图、流程图和/或示例包含一个或多个功能和/或操作,本领域的技术人员就要将其理解为此类框图、流程图和/或示例中的每个功能和/或操作都可以单独和/或共同地通过多种硬件、软件、固件或实际上它们的任何组合来实施。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一种或多种程序产品进行分布,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。信号承载介质的示例包括但不限于如下:可录式媒体,诸如软盘、硬盘驱动器、光盘(CD)、数字视频光盘(DVD)、数字磁带、计算机存储器等;和传输式介质,诸如数字和/或模拟通信介质(例如,光纤缆线、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)。
在一些情况下,一个或多个元件可使用表达“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。应当理解,所描述的包含在不同其它部件内或与不同其它部件连接的不同部件的架构仅是示例,并且事实上可以实施实现相同功能性的许多其它架构。在概念意义上,实现相同功能性的组件的任何布置都是有效“相关联的”,从而实现所需的功能性。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“相关联”,从而获得所需的功能性,而不论架构或中间组件如何。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”,以实现所需的功能性,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”,以实现所需的功能性。以可操作的方式联接的具体示例包括但不限于可物理匹配的和/或物理交互部件,和/或可无线交互的和/或无线交互部件,和/或逻辑交互和/或可逻辑交互的部件,和/或电交互部件和/或可电交互的部件,和/或光交互部件和/或可光交互的部件。
在其它情况下,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公开的特定方面,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。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,此类构造意在具有本领域的技术人员将理解所述惯例的意义(例如,“具有A、B和C中的至少一者的系统”将包括但不限于具有仅A、仅B、仅C、A和B一起、A和C一起、B和C一起和/或A、B和C一起等的系统)。在其中使用类似于“A、B或C中的至少一者等”的惯例的那些情况下,一般而言,此类构造意在具有本领域的技术人员将理解所述惯例的意义(例如,“具有A、B或C中的至少一者的系统”应当包括但不限于具有仅A、仅B、仅C、A和B一起、A和C一起、B和C一起和/或A、B和C一起等的系统)。本领域的技术人员还应当理解,通常,除非上下文另有指示,否则无论在具体实施方式、权利要求或附图中呈现两个或更多个替代术语的转折性词语和/或短语应理解为涵盖包括所述术语中的一者、所述术语中的任一个或这两个术语的可能性。例如,短语“A或B”通常将被理解为包括“A”或“B”或“A和B”的可能性。
对于所附的权利要求,本领域的技术人员将会理解,其中表述的操作通常可以任何顺序进行。另外,尽管以一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(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”、“在一方面”、“在一种形式中”或“在一形式中”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。
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。
在某些情况下,对系统或方法的使用可发生在一个地区中,即使部件位于所述地区外部。例如,在分布式计算上下文中,对分布式计算系统的使用可发生在一个地区中,即使所述系统的部件可能位于所述地区外部(例如,位于所述地区外部的继电器、服务器、处理器、信号承载介质、传输计算机、接收计算机等)。
系统或方法的销售同样可发生一个地区中,即使所述系统或方法的部件位于和/或用于所述地区外部。此外,在一个地区中实施用于执行方法的系统的至少一部分不排除在另一个地区中使用所述系统。
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条款中陈述:
1.一种包括外科器械的系统,所述外科器械包括:柄部组件,所述柄部组件包括柄部;轴组件,所述轴组件联接到所述柄部组件;以及柔性电路,其中所述柄部组件包括所述柔性电路的近侧部分,并且所述轴组件包括所述柔性电路的远侧部分;所述轴组件还包括:外轴,所述外轴围绕所述柔性电路的所述远侧部分定位并且被构造成能够在所述柔性电路的所述远侧部分的至少一个子部分保持固定时改变位置;以及轴控制电子器件,所述轴控制电子器件包括固定部分和非固定部分,所述固定部分联接到所述柔性电路的所述远侧部分,并且所述非固定部分联接到所述外轴;其中所述轴控制电子器件的所述固定部分被构造成能够在所述外轴改变位置时测量到所述轴控制电子器件的所述非固定部分的距离。
2.根据条款1所述的系统,所述系统还包括处理器,所述处理器联接到所述柔性电路并且被配置成能够通过基于所述固定部分和所述非固定部分之间的距离的变化,计算所述轴控制电子器件的所述非固定部分的位置的三维变化,确定所述外轴的位置的三维变化。
3.根据条款1或2所述的系统,其中所述柄部组件包括:第一模块,所述第一模块包括所述柔性电路的所述近端部分;以及第二模块,所述第二模块包括所述柄部;所述第一模块被构造成能够从所述第二模块脱离。
4.根据条款3所述的系统,其中所述第一模块包括可通信地联接到所述柔性电路的所述近侧部分的第一组接触件,并且所述第二模块包括可通信地联接到所述柄部的第二组接触件。
5.根据条款4所述的系统,其中所述第一组接触件被构造成能够在所述第一模块联接到所述第二模块时可固定地互锁到所述第二组接触件。
6.根据条款5所述的系统,其中所述柄部被构造成能够通过所述第一组接触件和第二组接触件将电子信号传输到所述柔性电路。
7.根据条款1至6中任一项所述的系统,其中:所述轴组件包括关节运动接头、所述轴组件的第一部件和第二部件,所述第一部件和所述第二部件围绕所述关节运动接头联接;所述轴的所述第二部件被构造成能够围绕所述关节运动接头进行关节运动;所述柔性电路被构造成能够在所述关节运动接头内进行关节运动;所述轴控制电子器件的所述非固定部分固定地联接到所述轴的所述第二部件;并且所述轴控制电子器件的所述固定部件被构造成能够在所述轴组件的所述第二部件围绕所述关节运动接头进行关节运动时测量远离所述非固定部件的距离变化。
8.根据条款1至7中任一项所述的系统,其中:所述外轴被构造成能够围绕所述柔性电路旋转;并且所述轴控制电子器件的所述固定部件被构造成能够在所述外轴围绕所述柔性电路旋转时测量远离所述非固定部件的距离变化。
9.根据条款1至8中任一项所述的系统,其中:所述外科器械还包括联接到所述轴组件的远侧端部的端部执行器,所述端部执行器包括一对外科钳口;所述轴组件包括联接到所述一对外科钳口的夹持臂驱动器,所述夹持臂驱动器被构造成能够朝近侧和远侧平移以操纵所述一对外科钳口的运动;所述轴控制电子器件的所述非固定部件固定地联接到所述夹持臂驱动器;并且所述轴控制电子器件的所述固定部件被构造成能够在所述夹持臂驱动器平移时测量远离所述非固定部件的距离变化。
10.根据条款2所述的系统,其中所述处理器进一步被配置成能够通过测量由所述轴控制电子器件的所述固定部件确定的所述距离变化是否未能满足至少一个预定阈值,确定所述外科器械的误差状况。
11.根据条款1至10中任一项所述的系统,其中所述外科器械还包括旋转驱动器,所述旋转驱动器可通信地联接到所述柄部组件并且被构造成能够使所述轴组件的至少一部分旋转。
12.根据条款1至11中任一项所述的外科器械。
13.一种不具有暂时性信号的计算机可读介质,包括指令,当所述指令由处理器执行时使所述处理器执行根据条款1至11中任一项所述的操作。

Claims (19)

1.一种外科系统,所述外科系统包括:
发生器和外科器械,所述发生器和所述外科器械电联接并被构造为向所述外科器械递送能量,并且所述外科器械包括:
柄部组件,所述柄部组件包括柄部;
轴组件,所述轴组件联接到所述柄部组件;以及
柔性电路,所述柔性电路包括电阻器、电容器、电感器和足够柔韧从而能够弯曲或扭曲的一系列基底层,所述一系列基底层跨越整个所述柔性电路,其中所述柄部组件包括所述柔性电路的近侧部分,并且所述轴组件包括所述柔性电路的远侧部分;
所述轴组件还包括:
外轴,所述外轴围绕所述柔性电路的所述远侧部分定位并且被构造成能够在所述柔性电路的所述远侧部分的至少一个子部分保持固定时改变位置;
轴控制电子器件,所述轴控制电子器件包括固定部分和非固定部分,所述固定部分联接到所述柔性电路的所述远侧部分,并且所述非固定部分联接到所述外轴;以及
限定传感器-磁体对的传感器和磁体,所述传感器被构造为测量其和所述磁体之间的距离;
其中所述轴控制电子器件的所述固定部分被构造成能够在所述外轴改变位置时使用所述传感器-磁体对测量到所述轴控制电子器件的所述非固定部分的距离。
2.根据权利要求1所述的外科系统,所述外科系统还包括处理器,所述处理器联接到所述柔性电路并且被配置成能够通过基于所述固定部分和所述非固定部分之间的距离的变化,计算所述轴控制电子器件的所述非固定部分的位置的三维变化,确定所述外轴的位置的三维变化。
3.根据权利要求1所述的外科系统,其中所述柄部组件包括:
第一模块,所述第一模块包括所述柔性电路的所述近侧部分;以及
第二模块,所述第二模块包括所述柄部;
所述第一模块被构造成能够从所述第二模块脱离。
4.根据权利要求3所述的外科系统,其中所述第一模块包括可通信地联接到所述柔性电路的所述近侧部分的第一组接触件,并且所述第二模块包括可通信地联接到所述柄部的第二组接触件。
5.根据权利要求4所述的外科系统,其中所述第一组接触件被构造成能够在所述第一模块联接到所述第二模块时可固定地互锁到所述第二组接触件。
6.根据权利要求5所述的外科系统,其中所述柄部被构造成能够通过所述第一组接触件和第二组接触件将电子信号传输到所述柔性电路。
7.根据权利要求1所述的外科系统,其中:
所述轴组件包括关节运动接头、所述轴组件的第一部件和第二部件,所述第一部件和所述第二部件围绕所述关节运动接头联接;
所述轴的所述第二部件被构造成能够围绕所述关节运动接头进行关节运动;
所述柔性电路被构造成能够在所述关节运动接头内进行关节运动;
所述轴控制电子器件的所述非固定部分固定地联接到所述轴的所述第二部件;并且
所述轴控制电子器件的所述固定部件被构造成能够在所述轴组件的所述第二部件围绕所述关节运动接头进行关节运动时测量远离所述非固定部件的距离变化。
8.根据权利要求1所述的外科系统,其中:
所述外轴被构造成能够围绕所述柔性电路旋转;并且
所述轴控制电子器件的所述固定部件被构造成能够在所述外轴围绕所述柔性电路旋转时测量远离所述非固定部件的距离变化。
9.根据权利要求1所述的外科系统,其中:
所述外科器械还包括联接到所述轴组件的远侧端部的端部执行器,所述端部执行器包括一对外科钳口;
所述轴组件包括联接到所述一对外科钳口的夹持臂驱动器,所述夹持臂驱动器被构造成能够朝近侧和远侧平移以操纵所述一对外科钳口的运动;
所述轴控制电子器件的所述非固定部分固定地联接到所述夹持臂驱动器;并且
所述轴控制电子器件的所述固定部件被构造成能够在所述夹持臂驱动器平移时测量远离所述非固定部件的距离变化。
10.根据权利要求2所述的外科系统,其中所述处理器进一步被配置成能够通过测量由所述轴控制电子器件的所述固定部件确定的所述距离变化是否未能满足至少一个预定阈值,确定所述外科器械的误差状况。
11.根据权利要求1所述的外科系统,其中所述外科器械还包括旋转驱动器,所述旋转驱动器可通信地联接到所述柄部组件并且被构造成能够使所述轴组件的至少一部分旋转。
12.一种外科器械,所述外科器械包括:
柄部组件,所述柄部组件包括柄部;
轴组件,所述轴组件联接到所述柄部组件;以及
柔性电路,所述柔性电路包括电阻器、电容器、电感器和足够柔性从而能够弯曲或扭曲的一系列基底层,所述一系列基底层跨越整个所述柔性电路,其中所述柄部组件包括所述柔性电路的近侧部分,并且所述轴组件包括所述柔性电路的远侧部分;
所述轴组件还包括:
外轴,所述外轴围绕所述柔性电路的所述远侧部分定位并且被构造成能够在所述柔性电路的所述远侧部分的至少一个子部分保持固定时改变位置;
轴控制电子器件,所述轴控制电子器件包括固定部分和非固定部分,所述固定部分联接到所述柔性电路的所述远侧部分,并且所述非固定部分联接到所述外轴;以及
限定传感器-磁体对的传感器和磁体,所述传感器被构造为测量其和所述磁体之间的距离;
其中所述轴控制电子器件的所述固定部分被构造成能够在所述外轴改变位置时使用所述传感器-磁体对测量到所述轴控制电子器件的所述非固定部分的距离。
13.根据权利要求12所述的外科器械,所述外科器械还包括处理器,所述处理器联接到所述柔性电路并且被配置成能够通过基于所述固定部分和所述非固定部分之间的距离的变化,计算所述轴控制电子器件的所述非固定部分的位置的三维变化,确定所述外轴的位置的三维变化。
14.根据权利要求12所述的外科器械,其中所述柄部组件包括:
第一模块,所述第一模块包括所述柔性电路的所述近侧部分;以及
第二模块,所述第二模块包括所述柄部;
所述第一模块被构造成能够从所述第二模块脱离。
15.根据权利要求14所述的外科器械,其中所述第一模块包括可通信地联接到所述柔性电路的所述近侧部分的第一组接触件,并且所述第二模块包括可通信地联接到所述柄部的第二组接触件。
16.根据权利要求15所述的外科器械,其中所述第一组接触件被构造成能够在所述第一模块联接到所述第二模块时可固定地互锁到所述第二组接触件;并且所述柄部被构造成能够通过所述第一组接触件和第二组接触件将电子信号传输到所述柔性电路。
17.根据权利要求12所述的外科器械,其中:
所述轴组件包括关节运动接头、所述轴组件的第一部件和第二部件,所述第一部件和所述第二部件围绕所述关节运动接头联接;
所述轴的所述第二部件被构造成能够围绕所述关节运动接头进行关节运动;
所述柔性电路被构造成能够在所述关节运动接头内进行关节运动;
所述轴控制电子器件的所述非固定部分固定地联接到所述轴的所述第二部件;并且
所述轴控制电子器件的所述固定部件被构造成能够在所述轴组件的所述第二部件围绕所述关节运动接头进行关节运动时测量远离所述非固定部件的距离变化。
18.根据权利要求12所述的外科器械,其中:
所述外轴被构造成能够围绕所述柔性电路旋转;并且
所述轴控制电子器件的所述固定部件被构造成能够在所述外轴围绕所述柔性电路旋转时测量远离所述非固定部件的距离变化。
19.根据权利要求12所述的外科器械,其中:
所述外科器械还包括联接到所述轴组件的远侧端部的端部执行器,所述端部执行器包括一对外科钳口;
所述轴组件包括联接到所述一对外科钳口的夹持臂驱动器,所述夹持臂驱动器被构造成能够朝近侧和远侧平移以操纵所述一对外科钳口的运动;
所述轴控制电子器件的所述非固定部分固定地联接到所述夹持臂驱动器;并且
所述轴控制电子器件的所述固定部件被构造成能够在所述夹持臂驱动器平移时测量远离所述非固定部件的距离变化。
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US20240081855A9 (en) 2024-03-14
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