CN105764435B - 具有电外科特征部的超声外科器械 - Google Patents

具有电外科特征部的超声外科器械 Download PDF

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CN105764435B
CN105764435B CN201480063408.1A CN201480063408A CN105764435B CN 105764435 B CN105764435 B CN 105764435B CN 201480063408 A CN201480063408 A CN 201480063408A CN 105764435 B CN105764435 B CN 105764435B
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D·W·普莱斯
B·D·迪克森
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Ethicon Endo Surgery Inc
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Abstract

本发明提供了一种外科器械系统，所述外科器械系统包括端部执行器、发生器和控制器。所述端部执行器包括超声刀和至少一个电极表面。所述发生器向所述端部执行器提供功率。所述端部执行器通过所述刀向组织施加超声能量，或者通过所述至少一个电极表面向组织施加射频能量。所述控制器被构造成能够在超声能量或射频能量中的一者或两者之间进行选择，从而基于感测到的所述端部执行器的操作条件来控制所述发生器在所述端部执行器处提供所选的超声能量或射频能量中的一者或两者。基于夹持臂相对于所述刀是否处于打开位置、基于哪个按钮被启动，以及基于在所述端部执行器处是否感测到组织，所述控制器可以在超声能量和射频能量之间进行选择。

Description

具有电外科特征部的超声外科器械
背景技术
多种外科器械包括端部执行器，该端部执行器具有以超声频率振动来切割和/或密封组织(例如，通过使组织细胞中的蛋白变性)的刀元件。这些器械包括将电力转换为超声振动的压电元件，该超声振动随声学波导传递至刀元件。切割和凝固的精度可受外科医生的技术以及对功率电平、刀刃、组织牵引力和刀片压力的调节的控制。
超声外科器械的示例包括HARMONIC超声剪(HARMONICUltrasonicShears)、HARMONIC超声剪(HARMONICUltrasonic Shears)、HARMONIC超声剪(HARMONICUltrasonic Shears)和HARMONIC超声刀(HARMONICUltrasonic Blades)，均购自Ethicon Endo-Surgery,Inc.(Cincinnati,Ohio)。此类装置的其他示例以及相关概念公开于以下专利中：1994年6月21日公布的名称为“Clamp Coagulator/Cutting System for Ultrasonic SurgicalInstruments”的美国专利No.5,322,055，其公开内容以引用方式并入本文；1999年2月23日公布的名称为“Ultrasonic Clamp Coagulator Apparatus Having Improved ClampMechanism”的美国专利No.5,873,873，其公开内容以引用方式并入本文；1997年10月10日提交的名称为“Ultrasonic Clamp Coagulator Apparatus Having Improved Clamp ArmPivot Mount”的美国专利No.5,980,510，其公开内容以引用方式并入本文；2001年12月4日公布的名称为“Blades with Functional Balance Asymmetries for use withUltrasonic Surgical Instruments”的美国专利No.6,325,811，其公开内容以引用方式并入本文；2004年8月10日公布的名称为“Blades with Functional Balance Asymmetriesfor Use with Ultrasonic Surgical Instruments”的美国专利No.6,773,444，其公开内容以引用方式并入本文；以及2004年8月31日公布的名称为“Robotic Surgical Tool withUltrasound Cauterizing and Cutting Instrument”的美国专利No.6,783,524，其公开内容以引用方式并入本文；
超声外科器械的其他示例公开于以下专利公布中：2006年4月13日公布的名称为“Tissue Pad Use with an Ultrasonic Surgical Instrument”的美国公布No.2006/0079874，其公开内容以引用方式并入本文；2007年8月16日公布的名称为“UltrasonicDevice for Cutting and Coagulating”的美国公布No.2007/0191713，其公开内容以引用方式并入本文；2007年12月6日公布的名称为“Ultrasonic Waveguide and Blade”的美国公布No.2007/0282333，其公开内容以引用方式并入本文；2008年8月21日公布的名称为“Ultrasonic Device for Cutting and Coagulating”的美国公布No.2008/0200940，其公开内容以引用方式并入本文；2009年4月23日公布的名称为“Ergonomic SurgicalInstruments”的美国公布No.2009/0105750，其公开内容以引用方式并入本文；2010年3月18日公布的名称为“Ultrasonic Device for Fingertip Control”的美国公布No.2010/0069940，其公开内容以引用方式并入本文；以及2011年1月20日公布的名称为“RotatingTransducer Mount for Ultrasonic Surgical Instruments”的美国公布No.2011/0015660，其公开内容以引用方式并入本文；以及2012年2月2日公布的名称为“UltrasonicSurgical Instrument Blades”的美国公布No.2012/0029546，其公开内容以引用方式并入本文。
一些超声外科器械可包括无线换能器，所述无线换能器为例如公开于以下专利公布中的无线换能器：2012年5月10日公布的名称为“Recharge System for MedicalDevices”的美国公布No.2012/0112687，其公开内容以引用方式并入本文；2012年5月10日公布的名称为“Surgical Instrument with Charging Devices”的美国公布No.2012/0116265，其公开内容以引用方式并入本文；和/或2010年11月5日提交的名称为“Energy-Based Surgical Instruments”的美国专利申请No.61/410,603，其公开内容以引用方式并入本文。
另外，一些超声外科器械可包括关节运动轴节段。此类超声外科器械的示例公开于以下专利申请中：2012年6月29日提交的名称为“Surgical Instruments withArticulating Shafts”的美国专利申请No.13/538,588，其公开内容以引用方式并入本文；以及2012年10月22日提交的名称为“Flexible Harmonic Waveguides/Blades forSurgical Instruments”的美国专利申请No.13/657,553，其公开内容以引用方式并入本文。
尽管已研制和使用了若干外科器械和系统，但据信在本发明人之前还无人研制出或使用所附权利要求中描述的发明。
附图说明
尽管本说明书得出了具体地指出和明确地声明这种技术的权利要求，但是据信从下述的结合附图描述的某些示例将更好地理解这种技术，其中相似的参考数字指示相同的元件，并且其中：
图1示出了示例性超声外科器械的侧正视图；
图2示出了另一个示例性超声外科器械的侧正视图；
图3示出了图2的器械的端部执行器的局部透视图；
图4示出了与图2的器械一起使用的另一个示例性端部执行器的局部透视图；
图5示出了与图2的器械一起使用的另一个示例性超声刀的端视图；
图6示出了与图2的器械一起使用的另一个示例性端部执行器的局部透视图；
图7示出了图2的器械的示例性电力操作的示意图；
图8示出了图2的器械的另一个示例性电力操作的示意图；
图9示出了图2的器械的另一个示例性电力操作的示意图；
图10示出了图2的器械的另一个示例性电力操作的示意图；
图11示出了图2的器械的另一个示例性电力操作的示意图；并且
图12示出了图2的器械的另一个示例性电力操作的示意图。
附图并非意在以任何方式进行限制，并且可以预期本发明的各种实施例能够以多种其他方式来执行，包括那些未必在附图中示出的方式。并入本说明书并构成其一部分的附图示出了本技术的若干方面，并且与说明书一起用于解释本技术的原理；然而，应当理解，这种技术不局限于所示的精确布置方式。
具体实施方式
下面描述的本技术的某些示例不应当用于限制本技术的范围。从下面的描述而言，本技术的其他示例、特征、方面、实施方案和优点对本领域的技术人员而言将是显而易见的，下面的描述以举例的方式进行，这是为实现本技术所设想的最好的方式之一。正如将意识到的，本文所述技术能够包括其他不同的和明显的方面，这些均不脱离本发明技术。因此，附图和具体实施方式应被视为实质上是示例性的而非限制性的。
还应当理解，本文所述的教导内容、表达方式、实施方案、示例等中的任何一者或多者可与本文所述的其他教导内容、表达方式、实施方案、示例等中的任何一者或多者相结合。下述教导内容、表达方式、实施方案、示例等不应视为彼此孤立。参考本文教导内容，其中本文教导内容可结合的各种合适方式将对本领域的普通技术人员显而易见。此类修改和变型旨在包括在权利要求书的范围内。
为公开的清楚起见，术语“近侧”和“远侧”在本文中是相对于外科器械的人或机器人操作者定义的。术语“近侧”是指更靠近外科器械的人或机器人操作者并且更远离外科器械的外科端部执行器的元件位置。术语“远侧”是指更靠近外科器械的外科端部执行器并且更远离外科器械的人或机器人操作者的元件位置。
I.示例性超声外科器械
图1示出了示例性超声外科器械10。器械10的至少一部分可根据以下专利的教导内容中的至少一些进行构造和操作：美国专利No.5,322,055、美国专利No.5,873,873、美国专利No.5,980,510、美国专利No.6,325,811、美国专利No.6,773,444、美国专利No.6,783,524、美国公布No.2006/0079874、美国公布No.2007/0191713、美国公布No.2007/0282333、美国公布No.2008/0200940、美国公布No.2009/0105750、美国公布No.2010/0069940、美国公布No.2011/0015660、美国公布No.2012/0112687、美国公布No.2012/0116265、美国专利申请No.13/538,588、美国专利申请No.13/657,553和/或美国专利申请No.61/410,603。上述专利、公布和申请中的每一者的公开内容以引用方式并入本文。如在这些专利中所述并且在下文中将更详细描述，器械10能够操作以基本上同时切割组织和密封或焊接组织(例如，血管等)。还应当理解，器械10可具有与HARMONIC超声剪、HARMONIC超声剪、HARMONIC超声剪和/或HARMONIC超声刀的各种结构和功能上的相似处。此外，器械10可具有与在本文中引述和以引用方式并入的其他参考文献中任一个教导的装置的各种结构和功能上的相似处。
在本文所引用的参考文献的教导内容、HARMONIC超声剪、HARMONIC超声剪、HARMONIC超声剪和/或HARMONIC超声刀以及与器械10有关的以下教导内容之间存在一定程度的重叠的情况下，本文中的任何描述无意被假定为公认的现有技术。本文中的若干教导内容事实上将超出本文所引用的参考文献的教导内容、HARMONIC超声剪、HARMONIC超声剪、HARMONIC超声剪和HARMONIC超声刀的范围。
本发明示例的器械10包括柄部组件20、轴组件30和端部执行器40。柄部组件20包括主体22，该主体包括手枪式握把24和一对按钮26。柄部组件20还包括触发器28，该触发器能够朝向和远离手枪式握把24枢转。然而，应当理解，可以使用各种其他合适的构型，包括但不限于剪刀式握持部构型。端部执行器40包括超声刀60和枢转夹持臂44。夹持臂44与触发器28联接，使得夹持臂44能够响应触发器28朝着手枪式握把24的枢转而朝着超声刀60枢转；并使得夹持臂44能够响应触发器28远离手枪式握把24的枢转而远离超声刀60枢转。参考本文的教导内容，夹持臂44可与触发器28联接的各种合适方式对于本领域的普通技术人员而言将是显而易见的。在一些型式中，使用一个或多个弹力构件来将夹持臂44和/或触发器28偏置到图1所示的打开位置。
超声换能器组件12从柄部组件20的主体22朝近侧延伸。换能器组件12经由线缆14与发生器16联接。换能器组件12从发生器16接收电力并通过压电原理将该电力转换成超声振动。发生器16可包括电源和被构造成能够向换能器组件12提供电力分布的控制模块，该电力分布特别适用于通过换能器组件12生成超声振动。仅以举例的方式，发生器16可包括由Ethicon Endo-Surgery,Inc.(Cincinnati,Ohio)出售的GEN 300。除此之外或作为替代，发生器16可根据以下专利的教导内容中的至少一些进行构造：2011年4月14日公布的名称为“Surgical Generator for Ultrasonic and Electrosurgical Devices”的美国公布No.2011/0087212，其公开内容以引用方式并入本文。还应当理解，可以将发生器16的至少一些功能整合到柄部组件20中，并且柄部组件20可以甚至包括电池或其他板载电源使得线缆14被省略。参考本文的教导内容，发生器16可采用的另外其他合适的形式以及发生器16可提供的各种特征部和可操作性对于本领域普通技术人员而言将是显而易见的。
本发明示例的端部执行器40包括夹持臂44和超声刀60。夹持臂44包括固定在夹持臂44的下侧的面向刀60的夹持垫。夹持臂44能够操作以选择性地朝向和远离刀60枢转，从而响应触发器28朝向手枪式握把24的枢转而选择性地在夹持臂44和刀60之间夹持组织。本发明示例的刀60能够操作从而以超声频率振动，以便有效地切割和密封组织，尤其是当组织被夹持于夹持臂44和刀60之间时。刀60定位在声学传动系的远侧端部处，该声学传动系包括用于振动刀60的换能器组件12。仅以举例的方式，声学传动系可以根据本文引用的各个参考文献的不同教导内容进行构造。
在本发明示例中，刀60的远侧端部位于与通过柔性声学波导传递的共振超声振动相关联的波腹对应的位置处，以便在声学组件未被组织承载时将其调谐至优选的共振频率fo。当换能器组件12通电时，刀60的远侧端部被构造成能够在例如大约10至500微米峰间范围内，并且在一些情况下在约20至约200微米的范围内，以例如55.5kHz的预定振动频率fo纵向移动。当本发明示例的换能器组件12被激活时，这些机械振荡通过波导传输至到达刀60处，从而以共振超声频率提供刀60的振荡。因此，当将组织固定在刀60和夹持臂44之间时，刀60的超声振荡可同时切割组织并且使相邻组织细胞中的蛋白质变性，从而提供具有相对较少热扩散的促凝效果。在一些型式中，也可通过刀60和夹持臂44提供电流以另外烧灼组织。尽管已描述了声学传输组件和换能器组件12的一些构型，但参考本文的教导内容，声学传输组件和换能器组件12的其他合适构型对于本领域普通技术人员而言将是显而易见的。相似地，参考本文的教导内容，端部执行器40的其他合适构型对于本领域普通技术人员而言将是显而易见的。
II.具有整合射频能量的示例性超声外科器械
在一些情况下，当使用器械10切割和密封组织时，在端部执行器40离开切开/密封的组织之后，手术部位处的组织的一些部分可能流血。可能期望提供一种或多种元件将射频(RF)能量传输到端部执行器40处的组织上(例如，以便凝固或密封该组织)，使得外科医生能够利用RF能量进一步以高度局部化方式密封流血组织，从而“修葺”这些流血组织区域。应当理解，以下任一种“出血部位修葺”特性可易于并入器械10的端部执行器40中。例如，这些特性可以直接整合到刀60和夹持臂44中的一者或两者中。另选地，这些特性可以以卡座、料筒或其他改装形式与端部执行器40联接。作为另一个仅为示例性的替代形式，这种特性可以作为分开的、独立的器械提供；或者可以并入不同的其他类型的外科器械中。
能够通过向组织施加射频能量来密封组织的外科器械的示例是Ethicon Endo-Surgery,Inc.(Cincinnati,Ohio)的组织密封装置。此类装置的其他示例以及相关概念公开于以下专利中：2002年12月31日公布的名称为“Electrosurgical Systemsand Techniques for Sealing Tissue”的美国专利No.6,500,176，其公开内容以引用方式并入本文；2006年9月26日公布的名称为“Electrosurgical Instrument and Method ofUse”的美国专利No.7,112,201，其公开内容以引用方式并入本文；2006年10月24日公布的名称为“Electrosurgical Working End for Controlled Energy Delivery”的美国专利No.7,125,409，其公开内容以引用方式并入本文；2007年1月30日公布的名称为“Electrosurgical Probe and Method of Use”的美国专利No.7,169,146，其公开内容以引用方式并入本文；2007年3月6日公布的名称为“Electrosurgical Jaw Structure forControlled Energy Delivery”的美国专利No.7,186,253，其公开内容以引用方式并入本文；2007年3月13日公布的名称为“Electrosurgical Instrument”的美国专利No.7,189,233，其公开内容以引用方式并入本文；2007年5月22日公布的名称为“Surgical SealingSurfaces and Methods of Use”的美国专利No.7,220,951，其公开内容以引用方式并入本文；2007年12月18日公布的名称为“Polymer Compositions Exhibiting a PTC Propertyand Methods of Fabrication”的美国专利No.7,309,849，其公开内容以引用方式并入本文；2007年12月25日公布的名称为“Electrosurgical Instrument and Method of Use”的美国专利No.7,311,709，其公开内容以引用方式并入本文；2008年4月8日公布的名称为“Electrosurgical Instrument and Method of Use”的美国专利No.7,354,440，其公开内容以引用方式并入本文；2008年6月3日公布的名称为“Electrosurgical Instrument”的美国专利No.7,381,209，其公开内容以引用方式并入本文。可根据上面引用的参考文献中的至少一些提供器械110的射频能量输送功能。
因此，器械10可提供一个或多个用于传输射频(RF)能量的元件，使得外科医生能够“修葺”流血组织区域。例如，图2示出具有射频能量功能的超声外科器械110。器械110与器械10类似，原因是器械110包括柄部组件120、轴组件130和端部执行器140。柄部组件120与柄部组件20类似，使得柄部组件120包括主体122，该主体包括手枪式握把124和能够朝向和远离手枪式握把124枢转的触发器128。超声换能器组件112从柄部组件120的主体122朝近侧延伸。换能器组件112经由线缆114与发生器116和控制器118联接。换能器组件112从发生器116接收电力并通过压电原理将该电力转换成超声振动。
端部执行器140与端部执行器40类似，原因是端部执行器140包括超声刀160和枢转夹持臂144。夹持臂144与触发器128联接，使得夹持臂144能够响应触发器128朝着手枪式握把124的枢转而朝着超声刀160枢转；并使得夹持臂144能够响应触发器128远离手枪式握把124的枢转而远离超声刀160枢转。本发明示例的刀160能够操作从而以超声频率振动，以便有效地切割和密封组织，尤其是当组织被夹持于夹持臂144和刀160之间时。在本发明示例中，刀160能够操作以响应柄部组件120上的按钮126的致动而输送超声能量。刀160还能够操作以向组织传输射频能量。图3示出了位于刀160的远侧末端上的电极表面150。电极表面150可在端部执行器140的涂覆过程中通过刀160远侧末端的掩膜而形成，使得刀160的远侧末端不具有涂层，诸如聚四氟乙烯(PTFE)，而刀160的其余部分具有涂层。虽然图3示出了位于刀160的远侧末端的电极表面150，但电极表面150也可以置于刀160和/或夹持臂144的其他区域上。电极表面150经由一个或多个沿着轴130的长度延伸的导体(未示出)与发生器116连通。另选地，电极表面150可经由通过波导主体(未示出)和刀160的导电与发生器116连通。
发生器116能够操作以将射频能量以主动极性传输至电极表面150，而患者可以接地，使得射频电流从电极表面150流向患者并由此穿过位于电极表面150邻近的组织。因此，该示例的器械110提供单极射频能量。为施加这种单极射频能量，需要接地功能，例如在患者下方放置接地垫或在患者上放置接地块等。在本发明示例中，射频能量响应柄部组件120上的按钮125的致动而传输到电极表面150上。在一些型式中，按钮126为专用超声按钮，而按钮125为专用射频按钮。在一些其他型式中，控制器118响应按钮125和/或按钮126的致动而确定是施加超声能量还是施加射频能量。这种自动化的实施例将在下文中进行更详细的描述。
控制器118调控从发生器116到换能器组件112和/或电极表面150的电力输送。图2示出了位于电外科器械10外部的控制器118和发生器116，但是控制器118和/或发生器116可以与电外科器械110一体化(例如，在手持件120等中)，如在本文或以其他方式所引用的一个或多个参考文献中所述。控制器118也可以集成到发生器116中。还应当理解，电极表面150可以采用多种备选位置、构型和关系。
例如，图4示出了与端部执行器140类似的另一个示例性端部执行器240，不同的是端部执行器240提供双极射频能量并且具有沿刀160侧部延伸的第二电极表面252。射频能量以主动极性输送到第一电极表面250，而第二电极表面252作为基准/返回被动电极，使得当电极表面250,252都被压贴到组织上时，射频电流在电极表面250,252之间流动，从而穿过位于电极表面250,252之间的组织区域。在一些情况下，外科医生可能需要用电极表面250,252向组织施加压力，以便用双极电极表面250,252适当地密封组织。当然，电极表面250,252可以置于端部执行器240的其他位置。例如，图5示出了刀460的远侧端部，其上具有一对位于刀460顶端并带有相反极性的电极表面450,452。因此，刀460的尖端用于密封位于电极表面450,452之间的组织。图6示出了与端部执行器240类似的另一个示例性端部执行器340，不同的是端部执行器340包括位于刀360的面向夹持臂344的一部分上的第一电极表面350和位于夹持臂344的面向刀360的一部分上的第二电极表面352。因此，射频被输送至端部执行器340，以便密封位于刀360和夹持臂344之间的组织。另选地，两个双极电极表面350,352可以位于夹持臂344上(例如，远侧末端处或侧面上，等等)。参考本文的教导内容，其他合适的电极构型对于本领域的普通技术人员而言将是显而易见的。
III.示例性自动能量输送
在一些型式中，可能期望将能量自动输送到端部执行器40,140,240,340。这样可以简化器械110的用户界面以避免混淆超声按钮126、射频按钮125以及手动可选的功率电平。向端部执行器40,140,240,340自动输送能量也可以防止在尝试密封大的血管而不是仅仅用射频按钮125“修葺”流血组织区域时错误使用射频按钮125。因此，柄部组件120的按钮126可以命名并用作“切割”按钮，并且柄部组件120的按钮125可以命名并用作“凝固”按钮。当致动按钮125,126时，控制器118可以基于感测条件向端部执行器40,140,240,340自动提供射频和/或超声功率。这些感测条件可以包括(但不必限于)：组织存在于夹持臂144,244,344和刀160,260,360,460之间，夹持臂144,244,344相对于刀160,260,360,460的位置，和/或被致动的按钮125,126。以下仅为向刀160,260,360,460和/或电极表面150,250,252,350,352,450,452提供自动功率的示例性示例。参考本文的教导内容，其他适合的自动能量构型对于本领域的普通技术人员而言将是显而易见的。
A.基于超声能量输送的完成的示例性自动射频能量输送
在一些型式中，器械110自动施加射频能量作为超声序列的一部分。例如，控制器118自动引发超声序列末端附近的射频算法(即，在刀160向组织施加足够的超声能后，端部执行器140向组织施加射频能量)。控制器118可通过换能器组件112振动的频率确定刀160,260,360,460上组织负载量的减少，从而检测超声序列的结束。另选地，可以在用户释放超声按钮126时测定超声序列的结束。控制器118可以通过引发低压射频脉冲进一步感测组织是否被横切并脱离端部执行器40,140,240,340，以测量端部执行器40,140,240,340的远侧部分处的组织阻抗。当在本文中使用术语“阻抗”时，不应将其解读为意指发明人仅仅设想使用交流电。在一些情况下，可以使用直流来测量在端部执行器40,140,240,340的远侧部分处的组织电阻。因此，术语“阻抗”应被解读为暗指包括“电阻”。换句话讲，本文使用的术语“阻抗”应被解读为“电阻”的同义词。
如果在该示例中阻抗水平足够高，这表明在端部执行器40,140,240,340处不存在组织。如果阻抗水平足够低，则表明在端部执行器40,140,240,340处存在组织。阻抗水平可以在电极表面150,250,252,350,352,450,452处测定，其形成通往端部执行器40,140,240,340的最小电阻路径。感测端部执行器40,140,240,340处的组织存在情况可以通过感测组织不存在而无需改变超声频率，从而防止电极表面150,250,252,350,352,450,452过热。参考本文的教导内容，其他合适的测定超声序列结束的方法对于本领域的普通技术人员而言将是显而易见的。
一旦检测到超声序列的结束，控制器118将连通发生器116，从而经由电极表面150,250,252,350,352,450,452向组织提供能量的射频脉冲。这产生高度局部化的凝固特征，该特征基于存在的组织，在超声序列结束之前的一刻自动触发。在组织从端部执行器40,140,240,340脱离之前，激活射频能量的输送。尽管在本示例中描述的是在超声序列结束时输送射频能量，但射频能量也可以在序列的其他部分激活，例如在开始时和/或在整个序列中周期性进行。这样可以确保在组织脱离端部执行器40,140,240,340之前进行凝固。当然，在一些情况下，刀160的超声振动可以单独提供足够的组织凝固/密封。
在一些型式中，低脉冲的射频能量周期性地施加于端部执行器40,140,240,340，以便测量在端部执行器40,140,240,340的远侧部分处的阻抗。这样可以感测到含铁流体(如血液)的存在。如果基于阻抗水平在端部执行器40,140,240,340处感测到含铁流体的存在，从而检测到流血组织，控制器118可停止激活超声能量，然后向端部执行器40,140,240,340施加循环射频能量。射频能量可施加于端部执行器40,140,240,340上，直到器械110感测到含铁流体减少或消失。这可能意味着，流血组织已被密封，超声操作可以被重新启动。应当理解，电极表面150,250,252,350,352,450,452可以易于用来感测组织阻抗。例如，控制器118可向电极表面150,250,252,350,352,450,452施加电压，然后基于所施加的电压，测量由组织提供的阻抗。其他可用于测量组织阻抗的合适结构和技术对于本领域的普通技术人员而言将是显而易见的。
B.基于操作模式的示例性自动化能量输送
在其他型式中，器械110的控制器118通过监控一系列条件来确定适当的操作模式，以基于这些条件提供自动的能量输送。例如，控制器118可以监控柄部组件120上的“切割”按钮125和/或“凝固”按钮126是否被致动，夹持臂144,244,344是打开还是闭合，以及/或者组织是否存在于刀160,260,360,460和夹持臂144,244,344之间或其附近。当然，这些条件中的任一种均可被省略、代替和/或补充，使得器械110的操作模式可以通过单个条件或其他条件的组合来确定。参考本文的教导内容，其他合适的条件对于本领域的普通技术人员而言将是显而易见的。
重新参照图2，柄部组件120包括被定位在触发器128上的传感器129。本发明示例的传感器129与控制器118通信，并且被构造成能够感测触发器128相对于夹持件124的位置。仅以举例的方式，传感器129可包括加速度计、应变仪、压电传感器等。因此，当触发器128被致动至打开或闭合位置时，传感器129与控制器118通信。传感器129还可感测触发器128的夹持力，以估计组织是否存在于端部执行器40,140,240,340处。因此，传感器129可感测施加到触发器128的力的量，以确定组织是否被压缩在夹持臂44,144,244,344和刀60,160,260,360,460之间。尽管本发明示例描述了定位在触发器128上的传感器129，但也可以使用其他类型的传感器129和/或将其设置在器械110(例如，端部执行器40,140,240,340等)的其他位置上。根据本文的教导内容，合适的替代传感器构型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40,140,240,340处组织的存在可以根据以下文献的教导内容中的至少一些进行感测：2012年5月10日公布的名称为“MotorDriven Electrosurgical Device With Mechanical and Electrical Feedback”的美国专利公布No.2012/0116379，其公开内容以引用方式并入本文。另选地，控制器118可以通过启动低电压射频脉冲来感测端部执行器40,140,240,340处组织的存在，以测量端部执行器40,140,240,340的远侧部分处的阻抗水平，如上所述。根据本文的教导内容，器械110可以感测端部执行器40,140,240,340处组织的存在的其他合适方式对于本领域的普通技术人员而言将是显而易见的。
基于上述感测条件，器械110随后可向器械110的端部执行器40,140,240,340提供自动化能量。表1仅示出了此类自动化能量输送到端部执行器40,140,240,340的示例性实施例，这是基于夹持臂44,144,244,344相对于刀60,160,260,360,460是打开的还是闭合的，“切割”按钮126或“凝固”按钮125是否启动，以及感测到组织是与端部执行器40,140,240,340相邻还是位于夹持臂44,144,244,344和刀60,160,260,360,460之间来进行的。表1中示出的算法可以按照控制器118中的控制逻辑执行。根据本文的教导内容，可用于存储和执行此类控制逻辑的各种合适硬件(例如，微处理器、专用集成电路、印刷电路板等)对于本领域普通技术人员而言将是显而易见的。表1如下文所示。
表1
在表1所示的第一实施例中，夹持臂44,144,244,344相对于刀60,160,260,360,460为闭合的，“凝固”按钮125是启动的，并且未在夹持臂44,144,244,344和刀60,160,260,360,460之间检测到组织。基于这些条件，感知到的外科意图在于执行点凝固或“局部”凝固。控制器118执行控制算法，以使发生器116在端部执行器40,140,240,340的电极表面150,250,252,350,352,450,452处提供射频能量。此类射频能量输送的示例示于图7中。从而电极表面150,250,252,350,352,450,452对定位在电极表面150,250,252,350,352,450,452附近(单极性型式)或之间(双极性型式)的组织执行点凝固或“局部”凝固。同时图7示出了通过器械110施加连续量的射频功率，射频功率电平可在整个序列过程中增加/减少，或者射频功率在序列过程中可以是脉冲式的。参考本文的教导内容，其他合适的射频功率构型对于本领域的普通技术人员而言将是显而易见的。
在表1所示的第二实施例中，夹持臂44,144,244,344相对于刀60,160,260,360,460为打开的，“凝固”按钮125是启动的，并且未在夹持臂44,144,244,344和刀60,160,260,360,460之间检测到组织。基于这些条件，感知到的外科意图在于执行点凝固或“局部”凝固。控制器118执行控制算法，以使发生器116在端部执行器40,140,240,340的电极表面150,250,252,350,352,450,452处提供射频能量，如图7所示。从而电极表面150,250,252,350,352,450,452对定位在电极表面150,250,252,350,352,450,452附近(单极性型式)或之间(双极性型式)的组织执行点凝固或“局部”凝固。同时图7示出了通过器械110施加连续量的射频功率，射频功率电平可在整个序列过程中增加/减少，或者射频功率在序列过程中可以是脉冲式的。参考本文的教导内容，其他合适的射频功率构型对于本领域的普通技术人员而言将是显而易见的。
表1的第三实施例示出夹持臂44,144,244,344相对于刀60,160,260,360,460为打开的，“凝固”按钮125是启动的，并且在夹持臂44,144,244,344和刀60,160,260,360,460之间存在组织。基于这些条件，感知到的外科意图在于使用端部执行器40,140,240,340密封和/或切割组织。在一些型式中，为了防止在这些情况下意外启动电极表面150,250,252,350,352,450,452和刀60,160,260,360,460并且夹持臂44,144,244,344相对于刀60,160,260,360,460打开，控制器118将阻止发生器116在端部执行器40,140,240,340处提供能量。控制器118可提示用户保持夹持臂44,144,244,344完全闭合，以施加能量至端部执行器40,140,240,340。除此之外或作为替代形式，控制器118可提示用户释放按钮125，或相反地按住按钮126。
作为另一个仅为示例性的替代形式，响应于上文第三实施例中所述的条件，控制器118可以执行控制算法，以使得发生器116在端部执行器40,140,240,340处提供射频能量和超声能量的组合。此类组合能量的示例如图8至图11所示。
图8示出了施加第一持续时间/时间段的连续射频功率。在第一时间段结束后，发生器116驱动刀60,160,260,360,460以低功率电平施加超声能量并持续第二持续时间/时间段。在第二时间段结束后，发生器116驱动刀60,160,260,360,460以高功率电平施加超声能量并持续第三持续时间/时间段。
另选地，发生器116可交替施加射频功率和超声功率。例如，图9示出了施加第一持续时间/时间段的射频功率。在第一时间段结束后，发生器逐步降低射频功率电平，以在端部执行器40,140,240,340处以更低功率施加射频能量并持续第二持续时间/时间段。在第二时间段结束后，发生器116驱动刀60,160,260,360,460以低功率电平施加超声能量并持续第三持续时间/时间段。在第三时间段结束后，发生器116逐步增加超声功率电平，在刀60,160,260,360,460处施加高电平的超声能量并持续第四持续时间/时间段。在第四时间段结束后，发生器116在端部执行器40,140,240,340处施加高电平的射频能量并持续第五持续时间/时间段。在第五时间段结束后，发生器116驱动刀60,160,260,360,460施加高功率电平的超声能量并持续第六持续时间/时间段。在第六时间段结束后，发生器116增加超声功率电平，以便以更高电平的超声能量驱动刀60,160,260,360,460并持续第七持续时间/时间段。
图10示出了在射频和超声功率之间为脉冲形式的组合射频和超声功率的另一个实施例。在图10中，施加射频功率并持续第一持续时间/时间段。在第一时间段结束后，发生器116降低了施加的射频能量，以便在端部执行器40,140,240,340处施加更低电平的射频能量并持续第二持续时间/时间段。在第二时间段结束后，发生器116驱动刀60,160,260,360,460施加低功率电平的超声能量并持续第三持续时间/时间段。在第三时间段结束后，发生器116向端部执行器40,140,240,340施加更低电平的射频能量并持续第四持续时间/时间段。发生器116可在超声能量和射频能量之间交替任何合适的次数。在本发明示例中，发生器116仅在任何指定的时刻施加超声能量或射频能量，使得超声能量和射频能量不被同时施加。然而，在一些其他型式中，超声能量和射频能量可以被同时施加。在本发明示例中，在完成交替功率序列后，发生器116驱动刀60,160,260,360,460施加高功率电平的超声能量并持续另外的持续时间/时间段。
在图11所示的示例性控制算法中，发生器提供连续量的射频功率并持续第一持续时间/时间段。在第一时间段结束后，发生器116驱动刀60,160,260,360,460施加低功率电平的超声能量并持续第二持续时间/时间段。在第二时间段结束后，发生器116施加低电平的射频能量并持续第三持续时间/时间段。在第三时间段结束后，发生器116驱动刀60,160,260,360,460施加低电平的超声能量并持续第四持续时间/时间段。在第四时间段结束后，发生器116施加高电平的射频能量并持续一定的持续时间/时间段。发生器116可在高电平射频能量、低电平超声能量和低电平射频能量之间交替任何合适的次数。然后，发生器116驱动刀60,160,260,360,460施加高电平的超声能量并持续另外的持续时间/时间段。
当然，上述仅为组合射频和超声功率构型的示例性实施例，并且参考本文教导内容，其他合适构型将对本领域的普通技术人员而言将是显而易见的。例如，发生器116可以同时向器械110施加射频和超声功率；或者功率的增加和/或减少可以是斜坡式的，而不是阶梯式的。在任何情况下，射频和超声功率的组合应用最终均可以切割和密封定位在端部执行器40,140,240,340之间的组织。
在表1所示的第四实施例中，夹持臂44,144,244,344相对于刀60,160,260,360,460为闭合的，“凝固”按钮125是启动的，并且在端部执行器40,140,240,340处检测到了组织。基于这些条件，感知到的外科意图在于使用端部执行器40,140,240,340密封和/或切割组织。控制器118自动与发生器116通信，以在端部执行器40,140,240,340处提供射频能量和超声能量的组合。此类组合能量可以根据上述图8至图11中所示的实施例提供。另选地，射频能量和超声能量的组合可以任何其他合适的方式提供。
在表1所示的第五实施例中，夹持臂44,144,244,344相对于刀60,160,260,360,460为打开的，“切割”按钮126是启动的，并且未在夹持臂44,144,244,344和刀60,160,260,360,460之间检测到组织。基于这些条件，感知到的外科意图在于使用刀60,160,260,360,460背面刻化组织。控制器118执行控制算法，以使发生器116向端部执行器40,140,240,340提供超声能量，如图12所示。同时图12示出了连续量的超声功率被施加到器械110，超声功率电平可在整个序列过程中增加/减少，或者超声功率在序列过程中可以是脉冲式的。参考本文的教导内容，其他合适的超声功率构型对于本领域的普通技术人员而言将是显而易见的。因此，较高或最大电平的超声功率可以被递送到端部执行器40,140,240,340的刀60,160,260,360,460上以背面刻化组织。这样可以为更多的无血管组织提供更快的切割。
在表1所示的第六实施例中，夹持臂44,144,244,344相对于刀60,160,260,360,460为闭合的，“切割”按钮126是启动的，并且在夹持臂44,144,244,344和刀60,160,260,360,460之间检测到了组织。基于这些条件，感知到的外科意图在于使用端部执行器40,140,240,340密封和切割组织。控制器118执行控制算法，以使发生器116向端部执行器40,140,240,340提供超声能量，如图12所示。因此，更高量的超声功率可以被递送到端部执行器40,140,240,340的刀60,160,260,360,460上，以密封和切割组织。同时图12示出了连续量的超声功率被施加到器械110，超声功率电平可在整个序列过程中增加/减少，或者超声功率在序列过程中可以是脉冲式的。参考本文的教导内容，其他合适的超声功率构型对于本领域的普通技术人员而言将是显而易见的。
在表1所示的第七实施例中，夹持臂44,144,244,344相对于刀60,160,260,360,460为打开的，“切割”按钮126是启动的，并且未在夹持臂44,144,244,344和刀60,160,260,360,460之间检测到组织。基于这些条件，感知到的外科意图在于(i)密封/切割具有较大组织咬伤的组织；(ii)使用刀60,160,260,360,460背面刻化组织；或者(iii)使用刀60,160,260,360,460在组织的切口中钻孔。控制器118执行控制算法，以使发生器116向端部执行器40,140,240,340提供超声能量，如图12所示。因此，更高量的超声功率可以被递送到端部执行器40,140,240,340的刀60,160,260,360,460上，以密封和切割组织。同时图12示出了连续量的超声功率被施加到器械110，超声功率电平可在整个序列过程中增加/减少，或者超声功率在序列过程中可以是脉冲式的。参考本文的教导内容，其他合适的超声功率构型对于本领域的普通技术人员而言将是显而易见的。
在表1所示的第八实施例中，夹持臂44,144,244,344相对于刀60,160,260,360,460为闭合的，“切割”按钮126是启动的，并且在夹持臂44,144,244,344和刀60,160,260,360,460之间检测到了组织。基于这些条件，感知到的外科意图在于(i)密封/切割组织，有极少量的组织或没有组织定位在夹持臂44,144,244,344和刀60,160,260,360,460之间；或者(ii)使用刀60,160,260,360,460执行点凝固或“局部”凝固。在一些型式中，这使得控制器118执行控制算法，使得发生器116向端部执行器40,140,240,340提供超声能量。在一些此类型式中，在这些条件下，超声功率的电平比图12和上述(在其他条件下)所示的情形下低。还应当理解，超声功率电平可在整个序列过程中增加/减少，或者超声功率在序列过程中可以是脉冲式的。参考本文的教导内容，其他合适的超声功率构型对于本领域的普通技术人员而言将是显而易见的。
在一些其他型式中，响应于上文第三实施例中所述的条件，控制器118可以执行控制算法，以使发生器116在端部执行器40,140,240,340的电极表面150,250,252,350,352,450,452处提供射频能量。此类射频能量输送的示例示于图7中。从而电极表面150,250,252,350,352,450,452对定位在电极表面150,250,252,350,352,450,452附近(单极性型式)或之间(双极性型式)的组织执行点凝固或“局部”凝固。同时图7示出了通过器械110施加连续量的射频功率，射频功率电平可在整个序列过程中增加/减少，或者射频功率在序列过程中可以是脉冲式的。参考本文的教导内容，其他合适的射频功率构型对于本领域的普通技术人员而言将是显而易见的。
IV.其他方面
应当理解，本文所述的任何型式的器械还可包括除上述那些之外或作为上述那些的替代的各种其他特征部。仅以举例的方式，本文所述的任何器械还可包括以引用方式并入本文的各种参考文献任何一者中公开的各种特征部中的一种或多种。还应当理解，本文的教导内容可以容易地应用于本文所引用的任何其他参考文献中所述的任何器械，使得本文的教导内容可以容易地以多种方式与本文所引用的任何参考文献中的教导内容组合。此外，本领域的普通技术人员将认识到本文中的各种教导内容可易于施加于电外科器械、缝合器械和其他类型的外科器械。可结合本文的教导内容的其他类型的器械对于本领域普通技术人员而言将是显而易见的。
应当理解，据称以引用的方式并入本文中的任何专利、出版物或其他公开材料，无论是全文或部分，仅在所并入的材料与本公开中所述的定义、陈述或者其他公开材料不冲突的范围内并入本文。因此，并且在必要的程度下，本文明确阐述的公开内容取代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所述的现有定义、陈述或其他公开材料相冲突的任何材料或其部分，仅在所并入的材料和现有的公开材料之间不产生冲突的程度下并入本文。
上文所述装置的型式可应用在由医疗专业人员进行的传统医疗处理和手术中、以及可应用在机器人辅助的医疗处理和手术中。仅以举例的方式，本文的各种教导内容可易于结合到机器人外科系统诸如Intuitive Surgical,Inc.(Sunnyvale,California)的DAVINCITM系统中。类似地，本领域的普通技术人员将认识到本文中的各种教导内容可易于结合如下专利中的各种教导内容：2004年8月31日公布的名称为“Robotic Surgical Toolwith Ultrasound Cauterizing and Cutting Instrument,”的美国专利No.6,783,524，其公开内容以引用方式并入本文。
上文所述型式可被设计成在单次使用后废弃，或者其可被设计成能够使用多次。在任一种情况下或两种情况下，可修复型式以在至少一次使用之后重复使用。修复可包括以下步骤的任意组合：拆卸装置，然后清洁或更换特定零件以及随后进行重新组装。具体地，可拆卸一些形式的所述装置，并且可选择性地以任何组合形式来更换或移除所述装置的任意数量的特定零件或部分。在清洁和/或更换特定部分时，所述装置的一些形式可在修复设施处重新组装或者在即将进行手术前由使用者重新组装以供随后使用。本领域的技术人员将会了解，装置的修复可以利用多种技术进行拆卸、清洁/更换以及重新组装。这些技术的使用和所得修复装置均在本申请的范围内。
仅以举例的方式，本文描述的形式可在手术之前和/或之后进行消毒。在一种消毒技术中，将该装置放置在闭合且密封的容器中，诸如塑料袋或TYVEK袋。然后可将容器和装置放置在可穿透所述容器的辐射场中，诸如γ辐射、X射线或高能电子。辐射可杀死装置上和容器中的细菌。然后将经杀菌的装置储存在无菌容器中，以供以后使用。还可使用本领域已知的任何其他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。
已经示出和描述了本发明的各种实施例，可在不脱离本发明的范围的情况下由本领域的普通技术人员进行适当修改来实现本文所述的方法和系统的进一步改进。已经提及了若干此类潜在修改形式，并且其他修改形式对本领域的技术人员将是显而易见的。例如，上文所讨论的示例、实施方案、几何形状、材料、尺寸、比率、步骤等均是例示性的而非所要求的。因此，本发明的范围应根据下面的权利要求书来考虑，并且应理解为不限于说明书和附图中示出和描述的结构和操作细节。

Claims (15)

1.一种外科器械系统，包括：
(a)端部执行器，所述端部执行器能够操作以操纵组织，其中所述端部执行器包括：
(i)超声刀，其中所述端部执行器能够操作以在所述刀处施加超声能量，以及
(ii)至少一个电极表面，其中所述至少一个电极表面包括第一电极表面，其中所述端部执行器还能够操作以通过所述至少一个电极表面施加射频能量；
(b)发生器，所述发生器能够操作以向所述端部执行器提供功率，其中所述发生器能够操作以驱动所述超声刀施加超声能量，其中所述发生器还能够操作以驱动所述至少一个电极表面施加射频能量；
(c)第一致动器，所述第一致动器能够操作以致动所述系统使用所述端部执行器横切组织；
(d)第二致动器，所述第二致动器能够操作以致动所述系统使用所述端部执行器密封组织；以及
(e)控制器，所述控制器与所述发生器通信，其中所述控制器被构造成能够感测所述端部执行器处组织的存在，并且其中所述控制器被构造成能够在超声能量或射频能量中的一者或两者之间进行选择，从而基于感测到的所述端部执行器的操作条件以及所述第一致动器和/或所述第二致动器的致动来控制所述发生器在所述端部执行器处提供所选的超声能量或射频能量中的一者或两者。
2.根据权利要求1所述的系统，其中所述第一电极表面定位于所述超声刀的远侧部分上。
3.根据权利要求1所述的系统，其中所述端部执行器包括第二电极表面。
4.根据权利要求3所述的系统，其中所述第一电极表面和所述第二电极表面定位于所述超声刀上。
5.根据权利要求3所述的系统，其中所述端部执行器包括能够相对于所述超声刀枢转的夹持臂，其中所述第一电极表面定位于所述超声刀上，其中所述第二电极表面定位于所述夹持臂上。
6.根据权利要求1所述的系统，其中所述控制器被构造成能够基于测得的与所述至少一个电极表面相关联的阻抗水平来感测所述端部执行器处组织的存在。
7.根据权利要求1所述的系统，其中所述端部执行器包括能够相对于所述超声刀枢转的夹持臂，其中所述控制器被构造成能够感测施加到所述夹持臂的力的量，以检测所述端部执行器处组织的存在。
8.根据权利要求1所述的系统，其中所述端部执行器包括能够相对于所述超声刀枢转的夹持臂，其中所述控制器被构造成能够感测所述夹持臂相对于所述超声刀的位置。
9.根据权利要求1所述的系统，其中所述控制器被构造成能够在所述第二致动器被致动并且未在所述端部执行器处感测到组织时，控制所述发生器在所述端部执行器处提供射频能量。
10.根据权利要求1所述的系统，其中所述控制器被构造成能够在所述第二致动器被致动并且在所述端部执行器处感测到组织时，控制所述发生器在所述端部执行器处提供射频能量和超声能量的组合。
11.根据权利要求1所述的系统，其中所述控制器被构造成能够在所述第一致动器被致动时，控制所述发生器提供超声能量。
12.根据权利要求1所述的系统，其中所述控制器被构造成能够控制所述发生器提供连续量的射频能量。
13.根据权利要求1所述的系统，其中所述控制器被构造成能够控制所述发生器提供连续量的超声能量。
14.根据权利要求1所述的系统，其中所述控制器被构造成能够控制所述发生器提供射频能量和超声能量的交替脉冲。
15.根据权利要求1所述的系统，其中所述控制器被构造成能够控制所述发生器自动提供射频能量和/或超声能量的量的增加或减少。
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