CN115190780A - 用于与可移动rf电极配合接合的不对称分段超声支撑垫 - Google Patents

用于与可移动rf电极配合接合的不对称分段超声支撑垫 Download PDF

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CN115190780A
CN115190780A CN202080091913.2A CN202080091913A CN115190780A CN 115190780 A CN115190780 A CN 115190780A CN 202080091913 A CN202080091913 A CN 202080091913A CN 115190780 A CN115190780 A CN 115190780A
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electrode
pad
clamp arm
clamp
end effector
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J·M·萨雷
C·P·布德雷奥克斯
T·N·布瑞姆
郭伟
E·伯卡特
J·D·梅瑟利
C·N·法勒
G·D·比什普
M·A·基南
W·A·奥尔森
R·W·弗莱克
F·E·谢尔顿四世
B·小布伦森
G·Y·卢卡斯
D·N·哈里斯
F·埃斯特拉
S·M·鲁克
N·玛斯特罗伊安尼
G·S·斯特罗布尔
J·S·萨尔古罗
L·M·瓦伦特
J·H·凯佩
J·E·布拉迪
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Cilag GmbH International
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Abstract

本发明公开了一种端部执行器，该端部执行器包括超声刀和夹持臂，该超声刀被配置为能够声学联接到超声波换能器并且电联接到发电机的一个极，该夹持臂包括夹钳和固定到该夹钳的悬臂式电极。该悬臂式电极被配置为能够电联接到该发电机的相反极。该夹持臂可以包括I形梁形夹持臂垫，并且该悬臂式电极设置在该I形梁之间。该夹钳、该悬臂式电极和该夹持臂垫可沿与该超声刀重合的长度限定凹陷部。该夹持臂垫可固定到该夹钳并且设置在该夹钳与该悬臂式电极之间，并且可延伸超出该悬臂式电极的表面。该夹持臂可包括静止间隙设定垫和可移动浮动间隙设定垫。

Description

用于与可移动RF电极配合接合的不对称分段超声支撑垫
相关申请的交叉引用
本申请按照美国法典第35卷第119条(e)款的规定要求于2019年12月30日提交的名称为“COMBINATION ENERGY MODALITY END-EFFECTOR”的美国临时专利申请序列号62/955,292的优先权，该美国临时专利申请的公开内容全文以引用方式并入本文。
技术领域
本公开整体涉及端部执行器，该端部执行器适于并被配置为能够采用多种能量模态操作，使得能够采用同时地、独立地或顺序地施加的能量模态来进行组织密封和切割。更具体地，本公开涉及端部执行器，该端部执行器适于并被配置为能够与采用组合的超声和电外科系统诸如单极或双极射频(RF)的外科器械一起操作，使得能够采用同时地、独立地或顺序地施加的超声和电外科能量模态来进行组织密封和切割。可基于组织参数或其他算法来施加能量模态。端部执行器可适于并被配置为能够联接到手持式或机器人外科系统。
背景技术
采用超声能量模态的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。根据具体器械构型和操作参数，超声外科器械能够基本上同时进行组织的切割和通过凝固的止血，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、超声刀或超声刀头来实现，该端部执行器、超声刀或超声刀头将超声能量传输到与该端部执行器接触的组织。超声端部执行器可包括超声刀、夹持臂和垫以及其他部件。
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质变性以形成粘性凝结物。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。
用于将电能模态施加到组织以治疗、密封、切割和/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具有安装在远侧的端部执行器的器械，该端部执行器包括一个或多个电极。该端部执行器可抵靠组织定位，使得电流被引入组织中。电外科器械能够被构造用于双极或单极操作。在双极操作期间，电流通过第一电极(例如，有源电极)被引入组织中并通过第二电极(例如，返回电极)从组织返回。在单极操作期间，电流通过端部执行器的有源电极被引入组织中并通过例如单独联接到患者身体的返回电极诸如接地垫返回。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还可包括能够相对于组织和电极移动以横切组织的切割构件。电外科端部执行器可适于并被配置为能够联接到手持式器械以及机器人器械。
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到器械。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，电外科器械可通过组织传递低频RF能量，这会引起离子振荡或摩擦，实际上造成电阻加热，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。RF能量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能量应用中，频率几乎可为任何值。单极应用通常可使用高于200kHz的频率，以便避免由于使用低频电流而导致不希望的对神经和肌肉的刺激。如果风险分析显示神经肌肉刺激的可能性已减轻至可接受的水平，则双极应用可使用较低频率。通常，不使用高于5MHz的频率以最小化与高频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。
本文所述性质的超声外科器械和电外科器械可被配置用于开放式外科规程、微创外科规程或非侵入式外科规程。微创外科规程涉及使用通过小切口插入的相机和器械，以便可视化和治疗关节或体腔内的状况。微创规程可完全在体内进行，或者在一些情况下，可与较小的开放式方案一起使用。这些组合方法例如被称为“关节镜、腹腔镜或胸腔镜辅助的外科规程”。本文所述的外科器械还可用于非侵入式规程，诸如例如内窥镜外科规程。这些器械可由外科医生使用手持器械或机器人来控制。
利用这些外科器械的挑战是不能根据正在治疗的组织的类型来控制和定制单个或多个能量模态。希望提供克服当前外科器械的一些缺陷并改善组织治疗、密封或切割或这些操作的组合的质量的端部执行器。本文所述的组合能量模态端部执行器克服了这些缺陷并改善了组织治疗、密封或切割或这些操作的组合的质量。
发明内容
在一个方面，提供了一种用于解剖和凝固组织的设备。该设备包括具有端部执行器的外科器械，该端部执行器适于并被配置为能够将多种能量模态递送到位于其远侧端部的组织。可同时地、独立地或顺序地施加能量模态。发生器电联接到外科器械并被配置为能够将多个能量模态提供给端部执行器。在一个方面，发生器被配置为能够将电外科能量(例如，单极或双极射频(RF)能量)和超声能量提供给端部执行器，以允许端部执行器与组织相互作用。能量模态可由单个发生器或多个发生器提供给端部执行器。
在各个方面，本公开提供了一种外科器械，该外科器械被配置为能够将至少两种能量类型(例如，超声、单极RF、双极RF、微波或不可逆电穿孔[IRE])递送到组织。该外科器械包括用于激活能量的第一激活按钮、用于为激活按钮选择能量模式的第二按钮。第二按钮连接到使用至少一个输入参数来定义能量模式的电路。可通过到发生器的连接或通过软件更新来远程修改输入参数。
在一个方面，本公开提供了一种组合式超声/双极RF能量外科装置。该组合式超声/双极RF能量外科装置包括端部执行器。端部执行器包括夹持臂和超声刀。夹持臂包括可移动夹钳、柔性聚合物垫和至少一个双极RF电极。至少一个电极联接到RF发生器的正极，并且超声刀联接到RF发生器的负极。超声刀声学联接到由超声发生器驱动的超声换能器叠堆。在一个方面，至少一个电极用作相对于相对的超声刀的可偏转支撑件。至少一个电极穿过超声刀并被配置为能够相对于夹持臂是可偏转的，该夹持臂具有改变至少一个电极下方的组织压缩的机械特性的特征部。至少一个电极包括防止电极和超声刀之间意外接触的特征部。
在另一方面，本公开提供了一种组合式超声/双极RF能量外科装置。该组合式超声/双极RF能量外科装置包括端部执行器。端部执行器包括夹持臂和超声刀。夹持臂包括可移动夹钳、柔性聚合物垫和至少一个双极RF电极。至少一个电极联接到RF发生器的正极，并且超声刀联接到RF发生器的负极。超声刀声学联接到由超声发生器驱动的超声换能器叠堆。在一个方面，可移动夹钳包括至少一个非偏置的可偏转电极，以最小化超声刀与RF电极之间的接触。超声刀垫包括用于将电极固定到垫的特征部。随着垫的高度磨损或被切穿，电极相对于夹钳的高度以渐进方式调节。一旦夹钳从超声刀移开，电极即保持在其新位置。
在另一方面，本公开提供了一种组合式超声/双极RF能量外科装置。该组合式超声/双极RF能量外科装置包括端部执行器。端部执行器包括夹持臂和超声刀。夹持臂包括可移动夹钳、柔性聚合物垫和至少一个双极RF电极。至少一个电极联接到RF发生器的正极，并且超声刀联接到RF发生器的负极。超声刀声学联接到由超声发生器驱动的超声换能器叠堆。在一个方面，至少一个双极RF电极是可偏转的并且具有比近侧偏置更多的远侧偏置。双极RF电极能够相对于夹钳偏转。端部执行器被配置为能够改变近侧端部至远侧端部的组织压缩的机械特性，以产生比单独夹持所产生的压力模式更均匀或不同的压力模式。
在另一方面，本公开提供了一种组合式超声/双极RF能量外科装置。该组合式超声/双极RF能量外科装置包括端部执行器。端部执行器包括夹持臂和超声刀。夹持臂包括可移动夹钳、柔性聚合物垫和至少一个双极RF电极。至少一个电极联接到RF发生器的正极，并且超声刀联接到RF发生器的负极。超声刀声学联接到由超声发生器驱动的超声换能器叠堆。在一个方面，双极RF电极是可偏转的，并且端部执行器沿该可偏转电极的长度提供可变的压缩/偏置。端部执行器被配置为能够基于夹钳闭合或夹持量来改变电极下方的组织压缩的机械特性。
在另一方面，本公开提供了一种组合式超声/双极RF能量外科装置。该组合式超声/双极RF能量外科装置包括端部执行器。端部执行器包括夹持臂和超声刀。夹持臂包括可移动夹钳、柔性聚合物垫和至少一个双极RF电极。至少一个电极联接到RF发生器的正极，并且超声刀联接到RF发生器的负极。超声刀声学联接到由超声发生器驱动的超声换能器叠堆。在一个方面，垫包括不对称的节段以提供对超声刀支撑件的支撑，并且电极是可移动的。该不对称的分段垫被配置用于与可移动双极RF电极协作接合。该分段超声支撑垫至少部分地延伸穿过双极RF电极。至少一个垫元件显著高于第二垫元件。第一垫元件整个地延伸穿过双极RF电极，并且第二垫元件部分地延伸穿过双极RF电极。第一垫元件和第二垫元件由不同材料制成。
在另一方面，本公开提供了一种组合式超声/双极RF能量外科装置。该组合式超声/双极RF能量外科装置包括端部执行器。端部执行器包括夹持臂和超声刀。夹持臂包括可移动夹钳、柔性聚合物垫和至少一个双极RF电极。至少一个电极联接到RF发生器的正极，并且超声刀联接到RF发生器的负极。超声刀声学联接到由超声发生器驱动的超声换能器叠堆。在一个方面，电极的物理参数的变化与可偏转电极结合使用，以改变递送到组织的能量密度和组织相互作用。电极的物理方面沿其长度变化，以便随着电极也偏转而改变电极与组织的接触面积和/或能量密度。
在另一方面，本公开提供了一种组合式超声/双极RF能量外科装置。该组合式超声/双极RF能量外科装置包括端部执行器。端部执行器包括夹持臂和超声刀。夹持臂包括可移动夹钳、柔性聚合物垫和至少一个双极RF电极。至少一个电极联接到RF发生器的正极，并且超声刀联接到RF发生器的负极。超声刀声学联接到由超声发生器驱动的超声换能器叠堆。在一个方面，提供了一种超声换能器控制算法，以在检测到超声刀与电极之间的接触短路时减小由超声或RF发生器递送的功率，从而防止损坏超声刀。该超声刀控制算法监测电短路或超声刀与电极的接触。该检测用于在超过电阈值最小值时调节超声换能器的功率/振幅水平，并且将换能器功率/振幅阈值调节到低于可能导致损坏超声刀、超声发生器、双极RF电极或双极RF发生器的最小阈值的水平。所监测的电参数可以是组织阻抗(Z)或电连续性。功率调节可以是为了切断外科装置的超声发生器、双极RF发生器，或者它可以是对电参数、压力或时间或这些参数的任何组合的成比例响应。
在另一方面，本公开提供了一种组合式超声/双极RF能量外科装置。该组合式超声/双极RF能量外科装置包括端部执行器。端部执行器包括夹持臂和超声刀。夹持臂包括可移动夹钳、柔性聚合物垫和至少一个双极RF电极。至少一个电极联接到RF发生器的正极，并且超声刀联接到RF发生器的负极。超声刀声学联接到由超声发生器驱动的超声换能器叠堆。在一个方面，在夹持臂中提供夹钳的特征部或方面以最小化组织粘连并改进组织控制。夹持臂组织路径或夹持区域包括被配置为能够相对于夹持臂/超声刀调节组织路径以形成预定接触位置从而减少组织粘附和炭化的特征部。
在另一方面，本公开提供了一种组合式超声/双极RF能量外科装置。该组合式超声/双极RF能量外科装置包括端部执行器。端部执行器包括夹持臂和超声刀。夹持臂包括可移动夹钳、柔性聚合物垫和至少一个双极RF电极。至少一个电极联接到RF发生器的正极，并且超声刀联接到RF发生器的负极。超声刀声学联接到由超声发生器驱动的超声换能器叠堆。在一个方面，提供了部分导电夹持臂垫，以使电极能够磨穿并最小化超声刀与双极RF电极之间的电短路。该夹持臂垫包括导电部分和不导电部分，从而使得其充当双极RF电极中的一者，同时还充当超声刀的耐磨支撑结构。该夹持臂垫的导电部分围绕垫的周边定位并且不定位在超声刀接触区域的正下方。导电部分被配置为能够劣化或磨损，以防止与超声刀的任何接触中断剩余导电垫的导电性。
除上述内容之外，在诸如本公开的文本(例如，权利要求和/或具体实施方式)和/或附图的教导内容中列出和描述了各种其他方法和/或系统和/或程序产品方面。
上述内容是概述，因此可包括简化、概括、纳入部分和/或细节的省略；因此，本领域技术人员应当理解，该概述仅仅是说明性的，并不旨在以任何方式进行限制。本文描述的装置和/或过程和/或其他主题的其他方面、特征和优点将在本文列出的教导内容中变得显而易见。
在各方面中的一个或多个方面，相关系统包括但不限于用于执行本文引用的方法方面的电路和/或编程；电路和/或编程实际上可以是被配置为能够根据系统设计者的设计选择来影响本文引用的方法方面的硬件、软件和/或固件的任意组合。除上述内容之外，在诸如本公开的文本(例如，权利要求和/或具体实施方式)和/或附图的教导内容中列出和描述了各种其他方法和/或系统方面。
此外，应当理解，下述形式、形式表达、示例中的任何一个或多个可与下述其他形式、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。除了上述例示性方面、实施方案和特征，参考附图和下述具体实施方式，其他方面、实施方案和特征将变得显而易见。
附图说明
所述形式的新型特征部在随附权利要求书中具体阐述。然而，关于组织和操作方法的所述形式可通过结合附图参照以下描述最好地理解，其中：
图1是根据本公开的至少一个方面的与组合式超声/RF装置一起使用的端部执行器的夹持臂部分的透视图。
图2是根据本公开的至少一个方面的图1所示的夹持臂的分解图。
图3和图4是根据本公开的至少一个方面的框架的透视图。
图5是根据本公开的至少一个方面的电极的透视图。
图6是根据本公开的至少一个方面的夹持臂垫的透视图。
图7是根据本公开的至少一个方面的大间隙垫的透视顶视图。
图8是根据本公开的至少一个方面的小间隙垫的透视顶视图。
图9是图8所示的小间隙垫的透视底视图。
图10至图12示出了根据本公开的各个方面的包括适于可偏转/悬臂式电极应用的缩短的夹持臂的执行器，其中：
图10是根据本公开的至少一个方面的包括缩短的夹持臂、超声刀、电极和夹持臂垫的端部执行器的侧视图；
图11是根据本公开的至少一个方面的端部执行器的顶视图；并且
图12示出了根据本公开的至少一个方面的包括夹钳、电极和夹持臂垫的夹持臂。
图13示出了根据本公开的至少一个方面的包括夹钳、电极和夹持臂垫的端部执行器夹持臂。
图14示出了根据本公开的至少一个方面的包括夹钳、电极和夹持臂垫的端部执行器夹持臂。
图15示出了根据本公开的至少一个方面的包括夹钳、电极和夹持臂垫的端部执行器夹持臂。
图16示出了根据本公开的至少一个方面的被磨损掉的底部保持器齿，使得电极可由于预成形曲线而朝向夹钳移动。
图17示出了根据本公开的至少一个方面的包括夹钳、电极和夹持臂垫的端部执行器夹持臂。
图18示出了根据本公开的至少一个方面的具有被磨损掉的锥形轮廓的保持器壁，使得存在足够的熔化/流动离开具有锥形轮廓区域的保持器壁，以允许电极由于预成形曲线而朝向夹钳移动。
图19至图21示出了根据本公开的至少一个方面的端部执行器，该端部执行器包括夹持臂、超声刀、网格衬垫、设置在网格衬垫上方的柔性电极，以及用以设置柔性电极与超声刀之间的间隙的多个硬间隔件，其中：
图19示出了夹持臂打开并且厚度不均匀的组织(T1a、T2a、T3a)设置在柔性电极上方；
图20示出了夹持臂闭合以压缩组织；并且
图21是图19至图20所示的端部执行器的分解图。
图22是根据本公开的至少一个方面的导电聚合物夹持臂垫的剖视图。
图23是根据本公开的至少一个方面的被配置为能够取代常规电极的夹持臂垫的透视图。
图24示出了根据本公开的至少一个方面的包括图23所述的夹持臂垫的夹持臂。
图25示出了根据本公开的至少一个方面的如图23至图24中所述构造的夹持臂垫。
图26是根据本公开的至少一个方面的包括与组织接触的复合材料夹持臂垫的夹持臂的剖视图。
图27示出了根据本公开的至少一个方面的夹持臂，该夹持臂包括用于支撑附接到夹钳的支架或冲压件的夹钳以及夹持臂垫。
图28是沿图27中的截面28-28截取的剖视图。
图29是沿图27中的截面29-29截取的剖视图。
图30是根据本公开的至少一个方面的包括夹钳、导电垫和不导电垫的夹持臂的另选具体实施的剖视图。
图31是根据本公开的至少一个方面的包括夹钳、焊接到夹钳的支架或冲压件、导电垫和不导电垫的夹持臂的另选具体实施的剖视图。
图32示出了根据本公开的至少一个方面的嵌件模制电极。
图33示出了根据本公开的至少一个方面的包括超声刀、夹持臂和包含导电膜的夹持臂垫的端部执行器。
图34示出了图33所示的夹持臂。
图35是沿图34中的截面35-35截取的夹持臂的剖视图。
图36示出了根据本公开的至少一个方面的包括部分导电夹持臂垫的夹持臂。
图37至图39示出了根据本公开的至少一个方面的夹持臂，该夹持臂包括被构造用于与包括夹钳、超声刀(未示出)和电极的端部执行器一起使用的I形梁形夹持臂垫，其中：
图38是夹持臂的俯视图，示出了从电极上方观察的夹持臂垫；并且
图39是电极的俯视图，示出了用于将夹持臂垫可滑动地接纳在其中的纵向槽。
图40A至图40C示出了根据本公开的至少一个方面的组装图37至图39所示的夹持臂的方法，其中：
图40A示出了在焊接点处焊接到夹钳的近侧端部的电极；
图40B示出了可滑动地插入纵向槽中的夹持臂垫；并且
图40C示出了用于设定间隙的硬耐磨间隙设定垫可滑动地插入夹钳中。
图41至图43示出了根据本公开的至少一个方面的端部执行器，该端部执行器在电极内与超声刀重叠的位置处提供凹陷部，以最小化超声刀与电极之间的冲击，其中：
图41是根据本公开的至少一个方面的包括夹持臂、超声刀、电极和重聚合物支撑垫的端部执行器的剖视图；
图42是端部执行器的剖视图，其中重聚合物支撑垫磨损并且夹持臂与超声刀之间夹持有组织；并且
图43是端部执行器的放大视图。
图44至图45示出了根据本公开的至少一个方面的夹持臂，该夹持臂包括夹钳、与可移动浮动间隙设定垫组合的静止间隙设定垫，其中：
图44是夹持臂的俯视图，示出了静止间隙设定垫和可移动浮动间隙设定垫；并且
图45是夹持臂的侧视图，示出了夹钳、静止间隙设定垫、可移动浮动间隙设定垫、电极和夹持臂垫。
图46示出了根据本公开的至少一个方面的另选夹持臂，该夹持臂包括夹钳、位于远侧端部处的静止间隙设定垫、静止夹持臂垫以及位于近侧端部处的可移动浮动间隙设定垫。
图47示出了根据本公开的至少一个方面的另选夹持臂，该夹持臂包括夹钳、位于远侧端部处的静止间隙设定垫、静止夹持臂垫以及位于近侧端部处的可移动浮动间隙设定垫。
图48至图49示出了根据本公开的至少一个方面的采用包括小齿的电极的组合式超声/双极RF能量外科装置，其中：
图48示出了根据本公开的至少一个方面的包括夹持臂、超声刀、包括多个齿的电极、柔韧夹持臂垫和硬间隙设定垫的端部执行器；并且
图49示出了根据本公开的至少一个方面的包括夹持臂、超声刀、电极、柔韧夹持臂垫和硬间隙设定垫的端部执行器。
图50至图57示出了根据本公开的至少一个方面的夹持臂，该夹持臂包括结合有包括齿的夹持臂垫的可重新加载式电极，其中：
图50示出了根据本公开的至少一个方面的可重新加载式电极和夹持臂垫；
图51示出了包括位于夹钳内的可重新加载式电极和夹持臂垫的夹持臂；
图52是正从夹钳的前部可滑动地插入夹钳中的可重新加载式电极和夹持臂垫的侧视图；
图53是正从夹钳的前部可滑动地插入夹钳中的可重新加载式电极和夹持臂垫的顶视图；
图54是插入夹钳凹坑中的电极支腿和位于夹钳中的槽中的弯曲突片的剖视图；
图55是夹持臂凹坑的详细视图；
图56示出了通过按压弯曲突片来释放臂；并且
图57是作为冲压部件的可重新加载式电极和臂的详细视图，示出了金属片的延伸件以及用于接纳夹持臂垫的齿的孔口、用于接纳硬耐磨间隙垫的孔口以及用于接纳硬耐磨间隙垫的孔口。
图58至图60示出了根据本公开的至少一个方面的包括超声刀和夹持臂的端部执行器，该夹持臂包括弹簧加载式夹持臂垫，其中：
图58是端部执行器的透视图；
图59是端部执行器的剖视图；并且
图60是端部执行器的分解图。
图61示出了根据本公开的至少一个方面的弹簧加载式夹持臂垫。
图62示出了根据本公开的至少一个方面的包括弹簧加载式夹持臂垫的夹持臂。
图63示出了根据本公开的至少一个方面的包括弹簧加载式夹持臂垫、电极和间隙设定垫的夹持臂。
图64示出了根据本公开的至少一个方面的包括由弹性体弹簧均匀地升高的弹簧加载式夹持臂垫的夹持臂。
图65示出了根据本公开的至少一个方面的包括弹簧加载式夹持臂垫的夹持臂。
图66至图82示出了根据本公开的至少一个方面的端部执行器，该端部执行器包括浮动夹持臂的第一构型和第二构型与超声刀的组合，其中：
图66示出了端部执行器的两种构型；
图67是夹钳、电极和超声刀部件的分解图，这些超声刀部件对于浮动夹持臂的第一构型或第二构型中的任一者是通用的；
图68示出了浮动夹持臂的第一构型的夹持臂垫单元和单件式弹性/超弹性块部件；
图69示出了浮动夹持臂的第二构型的夹持臂垫单元和多件式弹性/超弹性块部件。
图70示出了根据本公开的至少一个方面的突出穿过在电极中形成的孔口但不彼此接触的夹持臂垫单元布局；
图71示出了由电极限定的尺寸和构造被设置成接纳夹持臂垫单元中的任一者的孔口；
图72是包括单件式弹性/超弹性块的第一构型夹持臂的组装图；
图73是根据本公开的至少一个方面的包括浮动夹持臂和超声刀的端部执行器的第一构型的剖视图。
图74是根据本公开的至少一个方面的包括浮动夹持臂和超声刀的端部执行器的第二构型的剖视图。
图75示出了根据本公开的至少一个方面的组装包括浮动夹持臂和超声刀的第一构型端部执行器的方法。
图76示出了根据图75组装的端部执行器；
图77示出了被推动成受到压缩的单件式弹性/超弹性块；
图78示出了超声刀与单个夹持臂垫单元之间的压力可由单件式弹性/超弹性块平衡的位置；
图79示出了根据本公开的至少一个方面的组装包括浮动夹持臂和超声刀的第二构型端部执行器的方法；
图80示出了根据图79组装的端部执行器；
图81示出了在组织体积较高的位置多件式弹性/超弹性块被推动成受到单个夹持臂垫单元压缩；并且
图82示出了超声刀与单个夹持臂垫单元之间的压力可由多件式弹性/超弹性块平衡的位置。
图83示出了根据本公开的至少一个方面的包括可选择性展开的垫齿的夹持臂。
图84是根据本公开的至少一个方面的图83所示的夹持臂的剖视图，该夹持臂包括以缩回构型定位在孔口内的可选择性展开的垫齿。
图85是根据本公开的至少一个方面的图83所示的夹持臂的剖视图，该夹持臂包括处于展开构型的可选择性展开的垫齿。
图86是根据本公开的至少一个方面的图83所示的夹持臂的详细剖视图，该夹持臂包括处于缩回构型的可选择性展开的垫齿。
图87A示出了根据本公开的至少一个方面的被配置为能够接纳如图87B至87C所示的散热材料块的端部执行器。
图87B示出了图87A所示的端部执行器的一个示例，其中散热材料块添加到或以其他方式固定地附接到由金属夹钳支撑的夹持臂垫。
图87C示出了具有磨损的夹持臂垫的散热材料块。
图88A示出了根据本公开的至少一个方面的包括金属夹钳和超声刀的端部执行器，其中金属夹钳的至少一些部分由散热材料制成。
图88B示出了另选的夹持臂垫。
图88C示出了散热材料，该散热材料包括具有高导热特性和高比热的材料中的任一种或两种，并且形成大表面积特征以随着热量积聚在夹持臂垫中而增强热扩散。
图89示出了图87A至87C和88A至图88C中所述的端部执行器的部件。
图90示出了根据本公开的至少一个方面的包括用于增大散热器部件的表面积的翅片的一种散热结构。
图91示出了根据本公开的至少一个方面的包括用于增大散热器部件的表面积的孔的另一种散热结构。
图92示出了根据本公开的至少一个方面的外科装置，该外科装置在装置上包括模式选择按钮开关。
图93A至图93C示出了根据本公开的至少一个方面的用于选择外科装置的各种操作模式的三个选项，其中：
图93A示出了第一模式选择选项，其中可向前或向后按压按钮开关以使外科器械在各种模式之间循环；
图93B示出了第二模式选择选项，其中向上或向下按压按钮开关以使外科器械在各种模式之间循环；并且
图93C示出了第三模式选择选项，其中向前、向后、向上或向下按压按钮开关以使外科器械在各种模式之间循环。
图94示出了根据本公开的至少一个方面的外科装置，该外科装置在装置的背面上包括模式选择按钮开关。
图95A示出了第一模式选择选项，其中随着模式按钮开关被按下以在各种模式之间切换，有色光在用户界面上指示所选模式。
图95B示出了第二模式选择选项，其中随着模式按钮开关被按下以在各种模式之间切换，屏幕指示所选模式(例如，LCD、电子墨水)。
图95C示出了第三模式选择选项，其中随着模式按钮开关被按下以在各种模式之间切换，所标记的灯指示所选模式。
图95D示出了第四模式选择选项，其中随着所标记的按钮开关被按下以选择模式，当选择了所标记的按钮开关时，它被点亮以指示所选模式。
图96示出了根据本公开的至少一个方面的包括触发器激活机构的外科装置。
图97示出了根据本公开的至少一个方面的包括金属夹钳、电极、多个夹持臂垫以及间隙垫的另选夹持臂。
图98是根据本公开的至少一个方面的包括与可视化系统、机器人系统和智能器械配对的外科集线器的外科系统。
图99示出了根据本公开的至少一个方面的发生器的示例。
图100是根据本公开的至少一个方面的能够组合以定制模块化能量系统的多种模块和其他部件的图。
图101A是根据本公开的至少一个方面的第一示例性模块化能量系统配置，其包括头模块和显示屏，该显示屏呈现用于中继关于连接到头模块的模块的信息的图形用户界面(GUI)。
图101B是根据本公开的至少一个方面的安装到推车的图101A所示的模块化能量系统。
图102示出了根据本公开的至少一个方面的示例性外科系统的透视图，该系统具有发生器和能够操作以利用超声能量和双极RF能量处理组织的外科器械。
图103示出了根据本公开的至少一个方面的图102的外科器械的端部执行器的顶部透视图，该端部执行器具有提供第一电极的夹持臂和提供第二电极的超声刀。
图104示出了根据本公开的至少一个方面的图103的端部执行器的底部透视图。
图105示出了根据本公开的至少一个方面的图102的外科器械的局部分解透视图。
图106示出了根据本公开的至少一个方面的图102的外科器械的轴组件的远侧部分和端部执行器的放大分解透视图。
具体实施方式
本专利申请的申请人拥有于2019年12月30日提交的以下美国临时专利申请，这些临时专利申请中的每一者的公开内容全文以引用方式并入本文：
·美国临时专利申请序列号62/955,294，名称为USER INTERFACE FOR SURGICALINSTRUMENT WITH COMBINATION ENERGY MODALITY END-EFFECTOR；
·美国临时专利申请序列号62/955,299，名称为ELECTROSURGICAL INSTRUMENTSFOR COMBINATION ENERGY DELIVERY；以及
·美国临时专利申请序列号62/955,306，名称为SURGICAL INSTRUMENTS。
本申请的申请人拥有与本申请于同一日期提交且各自全文以引用方式并入本文的以下美国专利申请：
·代理人案卷号END9232USNP1/190715-1，名称为USER INTERFACE FOR SURGICALINSTRUMENT WITH COMBINATION ENERGY MODALITY END-EFFECTOR；
·代理人案卷号END9233USNP1/190716-1M，名称为METHOD OF OPERATING ACOMBINATION ULTRASONIC/BIPOLAR RF SURGICAL DEVICE WITH A COMBINATION ENERGYMODALITY END-EFFECTOR；
·代理人案卷号END9233USNP2/190716-2，名称为DEFLECTABLE SUPPORT OF RFENERGY ELECTRODE WITH RESPECT TO OPPOSING ULTRASONIC BLADE；
·代理人案卷号END9233USNP3/190716-3，名称为NON-BIASED DEFLECTABLEELECTRODE TO MINIMIZE CONTACT BETWEEN ULTRASONIC BLADE AND ELECTRODE；
·代理人案卷号END9233USNP4/190716-4，名称为DEFLECTABLE ELECTRODE WITHHIGHER DISTAL BIAS RELATIVE TO PROXIMAL BIAS；
·代理人案卷号END9233USNP5/190716-5，名称为DEFLECTABLE ELECTRODE WITHVARIABLE COMPRESSION BIAS ALONG THE LENGTH OF THE DEFLECTABLE ELECTRODE；
·代理人案卷号END9233USNP7/190716-7，名称为VARIATION IN ELECTRODEPARAMETERS AND DEFLECTABLE ELECTRODE TO MODIFY ENERGY DENSITY AND TISSUEINTERACTION；
·代理人案卷号END9233USNP8/190716-8，名称为TECHNIQUES FOR DETECTINGULTRASONIC BLADE TO ELECTRODE CONTACT AND REDUCING POWER TO ULTRASONIC BLADE；
·代理人案卷号END9233USNP9/190716-9，名称为CLAMP ARM JAW TO MINIMIZETISSUE STICKING AND IMPROVE TISSUE CONTROL；以及
·代理人案卷号END9233USNP10/190716-10，名称为PARTIALLY CONDUCTIVECLAMP ARM PAD TO ENABLE ELECTRODE WEAR THROUGH AND MINIMIZE SHORT CIRCUITING。
本申请的申请人拥有于2020年5月28日提交且各自全文以引用方式并入本文的以下美国专利申请：
·美国专利申请序列号16/885,813，名称为METHOD FOR AN ELECTROSURGICALPROCEDURE；
·美国专利申请序列号16/885,820，名称为ARTICULATABLE SURGICALINSTRUMENT；
·美国专利申请序列号16/885,823，名称为SURGICAL INSTRUMENT WITH JAWALIGNMENT FEATURES；
·美国专利申请序列号16/885,826，名称为SURGICAL INSTRUMENT WITHROTATABLE AND ARTICULATABLE SURGICAL END EFFECTOR；
·美国专利申请序列号16/885,838，名称为ELECTROSURGICAL INSTRUMENT WITHASYNCHRONOUS ENERGIZING ELECTRODES；
·美国专利申请序列号16/885,851，名称为ELECTROSURGICAL INSTRUMENT WITHELECTRODES BIASING SUPPORT；
·美国专利申请序列号16/885,860，名称为ELECTROSURGICAL INSTRUMENT WITHFLEXIBLE WIRING ASSEMBLIES；
·美国专利申请序列号16/885,866，名称为ELECTROSURGICAL INSTRUMENT WITHVARIABLE CONTROL MECHANISMS；
·美国专利申请序列号16/885,870，名称为ELECTROSURGICAL SYSTEMS WITHINTEGRATED AND EXTERNAL POWER SOURCES；
·美国专利申请序列号16/885,873，名称为ELECTROSURGICAL INSTRUMENTS WITHELECTRODES HAVING ENERGY FOCUSING FEATURES；
·美国专利申请序列号16/885,879，名称为ELECTROSURGICAL INSTRUMENTS WITHELECTRODES HAVING VARIABLE ENERGY DENSITIES；
·美国专利申请序列号16/885,881，名称为ELECTROSURGICAL INSTRUMENT WITHMONOPOLAR AND BIPOLAR ENERGY CAPABILITIES；
·美国专利申请序列号16/885,888，名称为ELECTROSURGICAL END EFFECTORSWITH THERMALLY INSULATIVE AND THERMALLY CONDUCTIVE PORTIONS；
·美国专利申请序列号16/885,893，名称为ELECTROSURGICAL INSTRUMENT WITHELECTRODES OPERABLE IN BIPOLAR AND MONOPOLAR MODES；
·美国专利申请序列号16/885,900，名称为ELECTROSURGICAL INSTRUMENT FORDELIVERING BLENDED ENERGY MODALITIES TO TISSUE；
·美国专利申请序列号16/885,917，名称为CONTROL PROGRAM ADAPTATION BASEDON DEVICE STATUS AND USER INPUT；
·美国专利申请序列号16/885,923，名称为CONTROL PROGRAM FOR MODULARCOMBINATION ENERGY DEVICE；以及
·美国专利申请序列号16/885,931，名称为SURGICAL SYSTEM COMMUNICATIONPATHWAYS。
在详细说明外科器械的各种形式之前，应该指出的是，示例性形式的应用或使用并不局限于附图和具体实施方式中所示出的部件的构造和布置的细节。示例性形式可以单独实施，也可以与其他形式、变型和修改结合在一起实施，并可以通过多种方式实践或执行。此外，除非另外指明，否则本文所用的术语和表达是为了方便读者而对示例性形式进行描述而所选的，并非为了限制性的目的。
此外，应当理解，下述形式、形式表达、示例中的任何一个或多个可与下述其他形式、形式表达和示例中的任何一个或多个组合。
各种形式均涉及被配置用于在外科规程期间执行组织治疗、解剖、切割和/或凝固的改进的超声和/或电外科(RF)器械。在一种形式中，组合的超声和电外科器械可被配置用于开放式外科规程，但也应用于其他类型的外科规程，诸如微创腹腔镜、目视或胸腔镜规程，例如手持式或机器人辅助规程中的非侵入式内窥镜规程。通过同时地、独立地、顺序地或其组合选择性地应用多种能量模态来实现多功能性。例如，可通过同时地、独立地、顺序地或其组合选择性地使用超声和电外科能量(例如，单极或双极RF能量)来实现多功能性。
在一个方面，本公开提供了一种超声外科夹持设备，该超声外科夹持设备包括超声刀和可偏转RF电极，使得超声刀和可偏转RF电极协作以通过包括RF电极的设备的夹持机构与相关联的超声刀的协作来执行组织的密封、切割和夹持。夹持机构包括与超声刀协作以抓持其间的组织的枢转夹持臂。该夹持臂优选地具有夹持组织垫(也被称为“夹持臂垫”)，该夹持组织垫具有多个轴向间隔开的夹持齿、节段、元件或单个单元，这些夹持齿、节段、元件或单个单元与端部执行器的超声刀协作以实现对组织的期望的密封和切割效果，同时有利于在外科规程期间抓持和夹持组织。
在一个方面，本文所述的端部执行器包括电极。在其他方面，本文所述的端部执行器包括电极的另选形式，以提供RF能量到组织的柔性联接、适应垫磨损/变薄、最小化过量热的产生(低摩擦系数、压力)、最小化火花的产生、最小化由于电短路引起的中断或其他们的组合。电极在近侧端部处固定到夹钳并且在远侧端部处自由偏转。因此，在整个本公开中，电极可被称为悬臂梁电极或可偏转电极。
在其他方面，本文所述的端部执行器包括夹持臂机构，该夹持臂机构被配置为能够在垫与超声刀之间施加高压力以抓持和密封组织、最大化夹持臂电极在受限或困难场景下接触组织的可能性，受限或困难场景诸如例如薄组织、处于横向张力下的组织、组织隆起/垂直张力，尤其是隆起组织远离夹持臂时。
在其他方面，本文所述的端部执行器被配置为能够平衡电极之间的表面积/电流密度的匹配，平衡和最小化来自组织界面的热传导，诸如例如影响损伤形成和对称性、循环时间、残余热能。
在其他方面，本文所述的端部执行器被配置为能够最小化粘连、组织粘附(最小化锚定点)并且可包括小聚酰亚胺垫。
在各个方面，本公开提供了一种组合式超声/双极RF能量外科装置。该组合式超声/双极RF能量外科装置包括端部执行器。端部执行器包括夹持臂和超声刀。夹持臂包括可移动夹钳、柔性聚合物垫和至少一个双极RF电极。至少一个电极联接到RF发生器的正极，并且超声刀联接到RF发生器的负极。超声刀声学联接到由超声发生器驱动的超声换能器叠堆。在各个方面，端部执行器包括电极偏置机构。
在一个一般性方面，本公开涉及一种使用包括超声和先进双极RF能量的组合以及位于端部执行器的至少一个钳上的可移动RF电极的外科装置的方法。可移动RF电极具有从可移动RF电极的近侧端部到远侧端部的可变偏置力。可移动RF电极被分段成分立的部分，因此可处于电连通或彼此隔离。可移动RF电极由导电或部分导电材料制成。应当理解，本公开中所述的任何端部执行器都可被配置有电极偏置机构。
在一个方面，本公开提供了一种受限电极偏置机构，以防止超声刀对电极的损坏。一般来讲，在各个方面，本公开提供了一种与超声/RF组合装置一起使用的端部执行器，其中，所述端部执行器包括电极。在一个方面，该组合式超声/双极RF能量外科装置包括电极偏置机构。在一个方面，该受限电极偏置机构被配置为能够防止或最小化超声刀对电极的损坏。电极在近侧端部处固定到夹钳并且在远侧端部处自由偏转。因此，在整个本公开中，电极可被称为悬臂梁电极或可偏转电极。
在各个方面，本公开提供了一种仅在包括偏置阈值机构的一个端部处固定的电极悬臂梁。在一个方面，可偏转悬臂式电极被配置用于组合式超声/双极RF能量外科装置。
在一个方面，组合式超声/RF能量外科装置包括超声刀、夹持臂和至少一个穿过超声刀的电极。在一个方面，电极被配置为能够相对于夹持臂是可偏转的并且包括用于在电极与超声刀之间的压缩下改变组织的机械特性的多个特征部。在另一方面，电极包括防止电极与超声刀之间意外接触的特征部，以防止或最小化超声刀对电极的损坏。
在各个方面，电极包括附接在端部执行器的夹钳的近侧端部处的金属弹簧元件。金属弹簧元件限定用于接纳穿过其的一个或多个夹持臂垫(也被称为“组织垫”或“夹持组织垫”)的开口并且包括集成的最小间隙元件。电极的该构型提供了一种防止组织积聚在偏置机构周围的方法，组织积聚在偏置机构周围可能影响电极的性能。该构型还最小化磨损垫与偏置弹簧之间的结合，增强电极与夹持臂连接的强度，通过将聚酰亚胺垫附接到电极而最小化夹持臂垫的意外释放，以及实现电极之间的表面积/电流密度的平衡匹配。电极在近侧端部处固定到夹钳并且在远侧端部处自由偏转。因此，在整个本公开中，电极是可偏转的并且可被称为悬臂梁电极或可偏转电极。
图1至图9示出了根据本公开的至少一个方面的端部执行器的一个方面，该端部执行器包括被配置用于与组合式超声/双极RF能量装置一起使用的可偏转/悬臂式电极。图1是根据本公开的至少一个方面的与组合式超声/RF装置一起使用的端部执行器的夹持臂1000部分的透视图。为了本公开的简洁和清晰，未示出用作端部执行器的另一个夹持臂的超声刀。端部执行器被配置为能够使得超声刀是双极RF电路的一个极并且夹持臂1000是相反极。夹持臂1000与超声刀之间保持一致的RF电极间隙，以防止超声刀接触电极而导致刀断裂或短路。接受治疗的组织被夹持并压缩在夹持臂1000与超声刀之间。
夹持臂1000包括框架1002、电极1004、至少一个不导电小间隙垫1006、至少一个不导电大间隙垫1008、至少一个不导电夹持臂垫1010。在一个方面，小间隙垫1006和大间隙垫1008被配置为能够设定电极1004与超声刀之间的间隙。夹持臂垫1010被配置为能够抓握夹持臂1000与超声刀之间的组织以辅助组织的密封和切割。在其他方面，可交换不导电小间隙垫和不导电大间隙垫。在其他方面，不导电间隙垫简单地在尺寸方面不同，而与不导电间隙垫之间的相对尺寸差异无关。
夹持臂1000相对于端部执行器的枢转移动通过在其近侧端部1014处提供夹持臂1000的框架1002的至少一个(优选一对)杠杆部分1012来实现。杠杆部分1012定位在超声波导和端部执行器的相应相对侧上，并且与往复致动构件的驱动部分可操作地接合。致动构件相对于外管状护套和超声波导的往复移动由此实现夹持臂1000相对于端部执行器围绕枢转点1016的枢转移动。杠杆部分1012可分别定位在由驱动部分限定的一对开口中，或以其他方式适当地与其机械地联接，由此致动构件的往复移动通过驱动部分和杠杆部分1012起作用以使夹持臂1000枢转。
图2是根据本公开的至少一个方面的图1所示的夹持臂1000的分解图。在各个方面，电极1004由金属弹簧材料制成，该金属弹簧材料附接到夹持臂1000的框架1002的近侧端部1014处，使得电极1004可偏转。金属弹簧电极1004限定用于接纳穿过其的夹持臂垫1010的元件的开口1018，并且限定用于接纳用以设定电极1004与超声刀之间的最小间隙的间隙垫1006、1008的附加开口1020、1021。至少一个间隙垫1006设置在电极1004的远侧端部1022上。间隙垫1006、1008因此与电极1004集成。在该构型中，电极1004防止组织积聚在偏置机构(例如悬臂弹簧)周围，组织积聚在偏置机构周围可能影响电极1004的性能。该构型还最小化磨损夹持臂垫1010与偏置弹簧电极1004之间的结合，增强电极1004与夹持臂连接的强度，通过将间隙垫1006、1008附接到电极1004而最小化夹持臂垫1018的意外释放，以及实现电极之间的表面积/电流密度的平衡匹配。电极1004通过两个突出部1024附接到框架1002。如图3和图4所示，电极突出部1024附接到框架1002的近侧端部1014。
图3和图4是根据本公开的至少一个方面的框架1002的透视图。这些图示出了框架1002的近侧端部1014上的连接表面1026，用于将电极1004的近侧端部附接到框架1002。在一个方面，电极突出部1024焊接到框架1002的连接表面1026，使得电极1004以可偏转方式工作。
图5是根据本公开的至少一个方面的电极1004的透视图。该图示出了由弹簧材料制成的电极1004中的偏置，如电极1004沿纵向长度的弯曲所示。开口1018、1020、1021用于接纳间隙垫1006、1008和夹持臂垫1010。在一个方面，电极1004具有0.010"的厚度“d”，并且可在例如0.005"至0.015"的厚度范围内进行选择。另外参考图8和图9，开口1020的尺寸和构造被设置成接纳限定在间隙垫1006的底部部分上的突出部1036。
图6是根据本公开的至少一个方面的夹持臂垫1010的透视图。夹持臂垫1010包括从主干1030突出的多个夹持臂元件1032。在整个本公开中，夹持臂元件1032也被称为“齿”。在一个方面，夹持臂垫1010在间隙垫1006位于电极1004上的位置中限定孔口1028。另外参考图8和图9，由夹持臂垫1010限定的孔口1028的尺寸和构造被设置成接纳限定在间隙垫1006的底部部分上的突出部1036。在一个方面，夹持臂垫1010的材料比间隙垫1006、1008的材料软。在一个方面，夹持臂垫1010由不粘润滑材料制成，诸如聚四氟乙烯(PTFE)或类似的四氟乙烯合成含氟聚合物。PTFE是疏水的、非润湿的、高密度的和耐高温的多用途材料并且具有不粘特性。相比之下，间隙垫1006、1008由聚酰亚胺材料制成，并且在一个方面，例如由以商品名VESPEL为人所知并且由杜邦公司(DuPont)制造的耐用高性能聚酰亚胺基塑料或者其他合适的聚酰亚胺、聚酰亚胺聚合物合金、或PET(聚对苯二甲酸乙二醇酯)、PEEK(聚醚醚酮)、PEKK(聚醚酮酮)聚合物合金制成。除非下文另有说明，否则下文所述的夹持臂垫和间隙垫由本段所述的材料制成。
图7是根据本公开的至少一个方面的大间隙垫1008的透视顶视图。大间隙垫1008包括突出部1034，该突出部的尺寸和构造被设置成配合在电极1004的近侧端部1014处的开口1021内。图8是根据本公开的至少一个方面的小间隙垫1006的透视顶视图。图9是图8所示的小间隙垫1006的透视底视图。如图8和图9所示，小间隙垫1006包括位于底部部分处的突出部1036，该突出部的尺寸和构造被设置成接纳在由电极1004限定的开口1020和由夹持臂垫1010限定的孔口1028内。小间隙垫1006和大间隙垫1008由聚酰亚胺材料制成，并且在一个方面，由以商品名VESPEL为人所知并且由杜邦公司制造的耐用高性能聚酰亚胺基塑料制成。聚酰亚胺材料的耐久性确保电极间隙在正常磨损和撕裂下保持相对恒定。
在一个方面，本公开还提供了用于组合式超声和双极RF能量装置的另外端部执行器构型。本公开的该部分提供了用于组合式超声和双极RF能量装置的端部执行器构型。在这些构型中，端部执行器在RF电极间隙与超声刀(其用作双极RF电路的一个极)以及夹持臂(其用作双极RF电路的相反极)之间保持一致的间隙。在传统的端部执行器构型中，电极间隙由柔软的PTFE夹持臂垫设定，该垫在手术过程中可能会磨损。当夹持臂垫磨穿时，超声刀可接触电极，导致刀断裂或电短路，这两者都是不期望的。
为了克服这些和其他限制，本公开的各方面采用可偏转RF电极与包括固定到夹持臂的不粘润滑柔性(例如，PTFE)垫的夹持臂垫的组合。RF电极包括与刀接触以设定刀-电极间隙的耐磨的不导电垫。柔性夹持臂垫延伸穿过由电极限定的开口并对来自超声刀的夹持力作出反应。随着柔性夹持臂垫磨损，电极偏转以在刀与电极之间保持恒定的间隙。这种构型在装置的整个寿命期间在电极与超声刀之间提供一致的间隙，防止当超声刀接触电极时可能发生的短路和超声刀断裂，并且使得电极材料能够直接定位在与超声刀相对的一侧上以提高密封性能。电极在近侧端部处固定到夹钳并且在远侧端部处自由偏转。因此，在整个本公开中，电极可被称为悬臂梁电极或可偏转电极。
在一个方面，本公开提供了夹持臂/电极/垫的不对称配合以实现超声刀-RF电极相互作用。在一个方面，本公开提供了一种缩短的夹持臂。图10至图12示出了根据本公开的各个方面的包括适于可偏转/悬臂式电极应用的缩短的夹持臂的执行器。在一个方面，端部执行器被配置用于夹持臂、电极和夹持臂垫的不对称配合以实现超声刀/RF电极相互作用。电极适于并被配置用于与组合式超声/双极RF能量外科装置一起使用并且能够在负载作用下偏转，其中电极是双极RF电路的一个极并且超声刀是双极RF电路的相反极。
在一个方面，夹持臂的远侧端部缩短并且夹持臂垫的长度保持相同长度，使得夹持臂垫的远侧端部延伸超过夹持臂的远侧端部。这将允许电极过度延伸以最小化夹持臂的远侧端部电短路的可能性。这还可具有延长夹持臂垫寿命的有益效果，因为另外暴露的夹持臂垫材料将被磨穿。该构型还可取消使用远侧和中间间隙设置夹持臂垫，该夹持臂垫在本文中之前被称为例如可磨损夹持臂垫，用于设置和保持电极与超声刀之间的间隙。
图10是根据本公开的至少一个方面的包括缩短的夹持臂1682、超声刀1684、电极1686和夹持臂垫1688的端部执行器1680的侧视图。图11是端部执行器1680的顶视图。如图10至图11所示，超声刀1684和电极1686的长度基本上相同。夹持臂1682被缩短以允许电极1686过度延伸以防止电短路。在一个方面，在端部执行器1680的近侧端部1692处提供间隙设定垫1690。
图12示出了根据本公开的至少一个方面的包括夹钳1702、电极1704和夹持臂垫1706的夹持臂1700。释放夹持臂的远侧空间。夹持臂1700被配置用于与包括如本文其他章节所公开的超声刀的端部执行器一起使用。该构型释放了夹钳1702上的远侧空间1708。夹持臂垫1706(例如，PTFE)完全支撑在下面，但t形槽区域中和侧壁上的空间被释放，以允许更多夹持臂垫1706烧穿并且电极1704进一步偏转离开超声刀(未示出)。
在一个方面，本公开提供了一种利用垫的热行为来偏转电极的端部执行器。在一个方面，夹持臂垫的长度可与超声刀的长度相同，并且随着夹持臂垫由于压力或热而膨胀或改变形状，夹持臂垫材料(例如，PTFE)的热膨胀特性可用于使电极偏转出超声刀的路径。
在一个方面，提供了非偏置电极和垫。随着垫磨损，非偏置但可偏转的垫改变相对于夹持臂的位置。非偏置电极被配置为能够最小化超声刀与RF电极之间的接触。夹持臂垫包括用于将电极固定到夹持臂垫的特征部。在一个方面，随着夹持臂垫的高度磨损或被切穿，电极相对于夹持臂的高度以渐进方式调节。在另一方面，一旦夹持臂从超声刀移开，电极即保持在其新位置。电极在近侧端部处固定到夹持臂并且在远侧端部处自由偏转。因此，在整个本公开中，电极可被称为悬臂梁电极或可偏转电极。
包括上文关于图1至图12所述的可偏转/悬臂式电极的端部执行器的构型可与如下文关于图13至图18所述的偏置电极组合。
在一个方面，本公开提供了一种用于组合式超声/双极RF能量外科装置的端部执行器，随着夹持臂垫磨损，该端部执行器采用压力或夹钳压缩来调节电极的高度。在一个方面，夹持臂垫跟随具有可磨损止动件的夹持臂偏置电极。在一个方面，夹持臂垫包括用于将电极固定到垫的特征部。随着垫的高度磨损或被切穿，电极相对于夹持臂的高度以渐进方式调节。一旦夹持臂从超声刀移开，电极即保持在其新位置。
在组合式超声/双极RF能量外科装置上实现足够的夹持臂垫寿命需要在器械的整个寿命期间保持足够小但非零的夹持臂垫-电极间隙，以提供期望的超声和双极RF组织效应。电极适于并被配置用于与组合式超声/双极RF能量外科装置一起使用并且能够在负载作用下偏转，其中电极是双极RF电路的一个极并且超声刀是双极RF电路的相反极。
现有(种子)电极是在自由状态(无负载)下实际上水平或平行于夹持臂的扁平电极。电极在近侧端部处固定到夹持臂并且在远侧端部处自由偏转。因此，在整个本公开中，电极可被称为悬臂梁电极或可偏转/悬臂式电极。当夹持在组织上时，组织对电极施加负载，导致使其朝向夹持臂偏转。
在一个方面，随着垫磨损，电极“跟随”垫。在该方面，使用任何合适的紧固技术，诸如焊接、激光焊接、钎焊、锡焊、压制以及其他紧固技术，将电极朝向处于自由状态的夹持臂偏置(无论是通过形成/弯曲电极，还是通过不非平行于夹持臂来附接/焊接电极)。可磨损止动特征部(在垫上或其他地方)保持电极远离夹持臂，直到所述止动特征部在使用期间被磨损掉。一旦被磨损掉，电极就能够接近夹持臂。这些特征部可以是齿或棘轮形、垂直锥形或其他。
在一个方面，本公开提供了一种可偏转/悬臂式电极，其中在自由状态下，该电极被朝向夹持臂偏置并且可使用任何合适的紧固技术(诸如焊接、激光焊接、钎焊、锡焊、压制以及其他紧固技术)以一定角度附接并以制成预成形曲线。
在一个方面，本公开提供了一种具有可偏转/悬臂式电极的端部执行器，该电极包括可磨损止动特征部以防止电极到达或接触夹持臂。随着止动特征部磨损，电极朝向夹持臂移动，直到其到达下一个止动件。在一个方面，止动特征部与夹持臂垫同时磨损，以保持夹持臂垫与电极之间的适当间隙。这些特征部可与夹持臂垫完全分离。这些特征部可被配置为能够承受夹持负载，但由于热(熔化/流动)或磨蚀而被磨损掉。可能的示例包括一个或多个夹持臂垫(PTFE、聚酰亚胺或其他)上的齿和一个或多个夹持臂垫(PTFE、聚酰亚胺或其他)上的锥形轮廓。
图13示出了根据本公开的至少一个方面的包括夹钳1712、电极1714和夹持臂垫1716的端部执行器夹持臂1710。夹持臂1710被配置用于与包括如在整个本公开中所述的超声刀(未示出)的端部执行器一起使用。夹持臂1710还包括耐磨间隙垫1717，以在电极1714与超声刀之间设定间隙。如图所示，在自由状态下，电极1714以平的或水平方向1718偏置。电极1714在近侧端部处固定到夹钳1712并且在远侧端部处自由偏转。因此，在整个本公开中，电极1714可被称为悬臂梁电极或可偏转电极。
图14示出了根据本公开的至少一个方面的包括夹钳1722、电极1724和夹持臂垫1726的端部执行器夹持臂1720。夹持臂1720被配置用于与包括如在整个本公开中所述的超声刀(未示出)的端部执行器一起使用。夹持臂1720还包括耐磨间隙垫1727，以在电极1724与超声刀之间设定间隙。如图所示，在自由状态下，电极1724被配置为能够预成形的、弯曲的，或以其他方式沿线1728远离水平1718取向朝向夹钳1722偏置。电极1724在近侧端部处固定到夹持臂1720并且在远侧端部处自由偏转。因此，在整个本公开中，电极1724可被称为悬臂梁电极或可偏转电极。为了防止偏置的电极1724在偏置力的作用下朝向夹钳1722弯曲，夹持臂1720还包括保持器，以防止偏置的电极1724朝向夹钳1722弯曲并将偏置的电极1724保持在相对于超声刀呈大致平坦构型(例如，平行、平的或水平)。下面在图15至图18中描述了保持器(诸如保持器齿1738和具有锥形轮廓的保持器壁1760)的示例。
图15示出了根据本公开的至少一个方面的包括夹钳1732、电极1734和夹持臂垫1736的端部执行器夹持臂1730。夹持臂1730被配置用于与包括如在整个本公开中所述的超声刀(未示出)的端部执行器一起使用。夹持臂1730还包括耐磨间隙垫1737，以在电极1744与超声刀之间设定间隙。在自由状态下，电极1734被配置为能够预成形弯曲的、弯折的，或以其他方式朝向夹钳1732偏置。然而，在夹持臂垫1736上提供保持器齿1738或类似特征部以防止电极1734朝向夹钳1732弹入。在图16中，根据本公开的至少一个方面，当底部保持器齿1738被磨损掉时，电极1734可由于预成形曲线而朝向夹钳1732移动。电极1734在近侧端部处固定到夹持臂1730并且在远侧端部处自由偏转。因此，在整个本公开中，电极1734可被称为悬臂梁电极或可偏转电极。
图17示出了根据本公开的至少一个方面的包括夹钳1752、电极1754和夹持臂垫1756的端部执行器夹持臂1750。夹持臂1750被配置用于与包括如在整个本公开中所述的超声刀(未示出)的端部执行器一起使用。夹持臂1750还包括耐磨间隙垫1757，以在电极1754与超声刀之间设定间隙。在自由状态下，电极1754被配置为能够预成形有曲线、弯折的，或以其他方式朝向夹钳1752偏置1758。然而，在夹持臂垫1756上提供具有锥形轮廓的保持器壁1760或类似特征部以防止电极1754朝向夹钳1752弹入。
在图17中，根据本公开的至少一个方面，当锥形轮廓保持器壁1760被磨损掉时，存在离开锥形轮廓保持器壁1760的区域的足够的熔化/流动，以允许电极1754由于预成形曲线而朝向夹钳1752移动。电极1754在近侧端部处固定到夹钳1752并且在远侧端部处自由偏转。因此，在整个本公开中，电极1754可被称为悬臂梁电极或可偏转电极。
在一个方面，本公开提供了一种用于组合式超声/双极RF能量外科装置的端部执行器，该端部执行器采用恒定压力分布偏置机构。在一个方面，该端部执行器包括用于安装可偏转电极和使可偏转电极绝缘的弹性可压缩支撑件。在一个方面，可采用中空的蜂窝状或带腔室的弹性体支撑附接衬垫，以允许附接到其上的电极中的全部或部分偏转但朝向超声刀偏置。该构型可提供使电极与金属夹钳的其余部分热绝缘的附加有益效果。这也将在电极周围提供弹性体“帘”以最小化电极后方的组织积聚。在一个方面，适于弹性体单元的非撑条可偏转几何形状将使得偏转力在预定偏转范围内保持恒定。电极适于并被配置用于与组合式超声/双极RF能量外科装置一起使用并且能够在负载作用下偏转，其中电极是双极RF电路的一个极并且超声刀是双极RF电路的相反极。
上述构型防止电极在压缩状态下横向偏斜以防止短路。此外，可偏转电极附连到弹性体并且弹性体附连到金属夹持臂。弹簧的实体高度受到驱动允许的压缩量的限制，同时保持尽可能多的金属夹持臂。来自组织界面的热传导是平衡的并且最小化-影响损伤形成和对称性、循环时间和残余热能。
包括上文关于图1至图12所述的可偏转/悬臂式电极的端部执行器的构型可与设置在网格衬垫上方的柔性电极以及多个硬间隔件组合，以在柔性电极与超声刀之间设定间隙，如下文关于图19至图21所述。
如上文关于图13至图18所述的偏置电极的构型可与设置在网格衬垫上方的柔性电极以及多个硬间隔件组合，以在柔性电极与超声刀之间设定间隙，如下文关于图19至图21所述。
包括上文关于图1至图12所述的可偏转/悬臂式电极与上文关于图13至图18所述的偏置电极的组合的端部执行器的构型可与设置在网格衬垫上方的柔性电极以及多个硬间隔件组合，以在柔性电极与超声刀之间设定间隙，如下文关于图19至图21所述。
图19至图20示出了根据本公开的至少一个方面的端部执行器1810，该端部执行器包括夹持臂1812、超声刀1814、网格衬垫1816、设置在网格衬垫1816上方的柔性电极1818，以及用以在柔性电极1818与超声刀1814之间设定间隙的多个硬间隔件1820。图21是图19至图20所示的端部执行器1810的分解图。夹持臂垫1822设置在形成于网格衬垫1816内的槽1825内。网格衬垫1816用作弹簧状元件。硬间隔件1820用于设置柔性电极1818与超声刀1814之间的间隙。
在图19中，夹持臂1812是打开的并且厚度不均匀(T1a、T2a、T3a)的组织1824设置在柔性电极1818上方。在图20中，夹持臂1812闭合以压缩组织1824。夹持臂1812上的网格衬垫1816导致可变厚度组织1824(T1a、T2a、T3a)上具有一致的组织1824(T1b、T2b、T3b)压缩，使得：
Figure BDA0003721782690000271
更多背景技术公开内容可见于EP3378427、WO2019/006068，这些文献全文以引用方式并入本文。
在一个方面，本公开提供了一种用于组合式超声/双极RF能量外科装置的端部执行器，该端部执行器具有用于使用零间隙双极RF能量系统来确保远侧末端与偏置接触的装置。在各个方面，本公开提供了一种用于组合式超声/双极RF能量外科装置的可偏转电极，该可偏转电极具有比近侧偏置多的远侧偏置。在一个方面，本公开提供一种包括能够相对于夹持臂偏转的双极电极的组合能量装置。该组合能量装置包括改变近侧至远侧的组织压缩的机械特性的特征部，以产生比单独夹持所产生的压力模式更均匀或不同的压力模式。在一个方面，本公开提供了一种非线性远侧分布机构，并且在另一方面，本公开提供了能量密度的电非线性分布。电极适于并被配置用于与组合式超声/双极RF能量外科装置一起使用并且能够在负载作用下偏转，其中电极是双极RF电路的一个极并且超声刀是双极RF电路的相反极。
包括上文关于图1至图12所述的可偏转/悬臂式电极的端部执行器的构型可与如下文关于图22至图36所述的导电聚合物夹持臂垫组合。
如上文关于图13至图18所述的偏置电极的构型可与如下文关于图22至图36所述的导电聚合物夹持臂垫组合。
设置在网格衬垫上方的柔性电极和如上文关于图19至图21所述的用以在柔性电极与超声刀之间设定间隙的多个硬间隔件的构型可与如下文关于图22至图36所述的导电聚合物夹持臂垫组合。
如上文关于图13至图18所述的偏置电极的构型可与设置在网格衬垫上方的柔性电极组合，并且如上文关于图19至图21所述的用以在柔性电极与超声刀之间设定间隙的多个硬间隔件可与如下文关于图22至图36所述的导电聚合物夹持臂垫组合。
如上文关于图13至图18所述的偏置电极的构型可与设置在网格衬垫上方的柔性电极组合，并且如上文关于图19至图21所述的用以在柔性电极与超声刀之间设定间隙的多个硬间隔件可与如下文关于图22至图36所述的导电聚合物夹持臂垫组合。
包括上文关于图1至图12所述的可偏转/悬臂式电极与上文关于图13至18所述的偏置电极的组合的端部执行器的构型可与下文关于图22至图36所述的导电聚合物夹持臂垫组合。
包括上文关于图1至图12所述的可偏转/悬臂式电极与上文关于图13至图18所述的偏置电极的组合的端部执行器的构型可与设置在网格衬垫上方的柔性电极组合，并且如上文关于图19至图21所述的用以在柔性电极与超声刀之间设定间隙的多个硬间隔件可与如下文关于图22至图36所述的导电聚合物夹持臂垫组合。
在各个方面，本公开提供了一种组合式超声/双极RF能量外科装置，该外科装置包括具有部分导电部分或全部导电部分的超声垫，使得超声垫用作刀支撑件/磨损垫和双极RF电极两者。在一个方面，本公开提供了一种部分导电的夹持臂垫以能够磨损电极并最小化组合双极RF和超声能量装置中的短路，其中夹持臂垫具有导电部分和不导电部分，从而允许其用作RF电极中的一个电极，同时还用作超声刀的可磨损支撑结构。在另一方面，本公开提供了围绕夹持臂垫的周边并且不直接定位在与超声刀接触区域相对的侧上的导电部分。在另一方面，导电夹持臂垫的一部分是可降解的或可磨损的，以防止来自超声刀的接触中断导电夹持臂垫的其余部分的导电性。
在一个方面，本公开提供了一种用于组合式超声/双极RF能量外科装置的端部执行器，该端部执行器包括导电聚合物超声夹持臂垫。在一个方面，端部执行器包括掺杂有氧化锡的夹持臂垫。图22是根据本公开的至少一个方面的导电聚合物夹持臂垫2440的剖视图。导电聚合物夹持臂垫2440包括嵌入聚合物材料2444诸如聚四氟乙烯(PTFE)中的氧化锡2442(SnO2)，以使夹持臂垫2440导电。可使用冷喷涂工艺实现掺杂。一旦掺杂，导电聚合物夹持臂垫2440就可实现传统的超声组织夹持臂垫功能，诸如例如接触超声刀、吸收来自超声刀的热量以及帮助组织抓持和夹持。掺杂氧化锡的夹持臂垫2440用作双极RF电路的两个电极或极中的一个，以将RF能量递送到抓持在超声刀与夹持臂垫2440之间的组织。掺杂氧化锡的夹持臂垫2440是生物相容的、导电的、导热的，使得夹持臂垫2440的大部分能够用于提高夹持臂垫2440的耐磨性，并且是白色的。电极适于并被配置用于与组合式超声/双极RF能量外科装置一起使用并且能够在负载作用下偏转，其中电极是双极RF电路的一个极并且超声刀是双极RF电路的相反极。
在一个方面，本公开提供了一种作为电极替代物的导电聚合物超声夹持臂垫。为了延长超声夹持臂垫的寿命并提高RF组织效应，本公开提供了一种改进的、更易于制造的且制造成本更低的电极。在一个方面，本公开提供了一种包括硬聚酰亚胺聚合物层和导电层的夹持臂垫，以允许夹持臂垫实现传统功能并承载双极电，从而组合能量端部执行器的夹持臂中不再需要单独的电极。这样，夹钳可以类似于纯超声夹钳的方式制造，其中新的夹持臂垫材料与传统的纯超声夹持臂垫互换。电极适于并被配置用于与组合式超声/双极RF能量外科装置一起使用并且能够在负载作用下偏转，其中电极是双极RF电路的一个极并且超声刀是双极RF电路的相反极。
有益效果包括改进的超声性能，包括夹持臂垫磨损、类似于当前的纯超声器械，因为聚合物的元件“正方形”之间没有电极间隙。由于不需要单独的电极部件并且提供多个小的聚合物正方形元件，因此改进的夹钳的成本将类似于当前的纯超声夹钳。此外，制造夹钳所需的制造步骤与制造当前的纯超声夹钳所需的制造步骤相同。制造该改进的夹钳只需要替换夹持臂垫并且确实需要生产附加的电极部件来添加到夹钳以及消除了组装步骤。
图23是根据本公开的至少一个方面的被配置为能够取代常规电极的夹持臂垫2450的透视图。夹持臂垫2450包括夹层状构型的不导电层2452和导电层2454。该构型消除了对弹簧加载式电极板的需要。不导电层2452可由聚合物、聚酰亚胺、聚四氟乙烯(PTFE)和类似的不导电材料制成。导电层2454可由薄导电聚合物、金属箔或碳负载材料制成。夹持臂垫2450可被制造成使得接触超声刀的材料中的大部分是不导电层2452。在一个方面，接触超声刀的材料中的75％是不导电材料，诸如PTFE。在另一方面，接触超声刀的材料中的85％是不导电材料，诸如PTFE。在另一方面，接触超声刀的材料中的95％是不导电材料，诸如PTFE。另外，随着夹持臂垫2450磨损，导电层2452仍将具有用以通过组织和返回电极(例如，超声刀)传导RF电力的可用表面积。
图24示出了根据本公开的至少一个方面的包括图23所述的夹持臂垫2450的夹持臂2460。在所示的夹持臂2460中，与呈现为薄层或箔的导电层2454相比，不导电层2452具有大表面积。
图25示出了根据本公开的至少一个方面的如图23至图24中所述构造的夹持臂垫。第一夹持臂垫2470是新的并且包括与其一体形成的齿2472。第二夹持臂垫2476是新的但没有齿。第三夹持臂垫2478磨损并且可代表第一夹持臂垫2470或第二夹持臂垫2476。
在一个方面，本公开提供了一种用于组合式超声/双极RF能量外科装置的复合材料夹持臂垫。图26是根据本公开的至少一个方面的包括与组织2484接触的复合材料夹持臂垫2482的夹持臂2480的剖视图。端部执行器2480包括上夹钳2486和用以将复合材料夹持臂垫2482固定地附接到上夹钳2486的粘合剂2488。复合材料夹持臂垫2482包括薄的不导电层2490(例如，PTFE)和薄的导电层2492(例如，薄的不锈钢箔)。导电层2492形成复合材料夹持臂垫2482的电极部分。随着不导电层2490(例如，PTFE)被磨损掉，导电层2492(例如，薄的不锈钢箔)变形。导电层2492的厚度使得复合材料夹持臂垫2482的电极部分能够随着不导电层2490被磨损掉而变形。有利地，导电层2492将一些热量传导离开不导电层2490以保持复合材料夹持臂垫2482较冷。如上所述，复合材料夹持臂垫2482通过粘合剂2488固定到上夹钳2486。粘合剂2488可填充有碳以使其导电并将复合材料夹持臂垫2482的电极部分连接到上夹钳2486。电极适于并被配置用于与组合式超声/双极RF能量外科装置一起使用并且能够在负载作用下偏转，其中电极是双极RF电路的一个极并且超声刀是双极RF电路的相反极。
在一个方面，夹持臂垫包括协作的导电部分和绝缘部分。在一个方面，本公开提供了一种组合式超声/双极RF能量外科装置，其中夹持臂垫具有导电部分和不导电部分，允许其用作RF电极中的一个电极，同时还用作超声刀的可磨损支撑结构。在另一方面，夹持臂垫的导电部分围绕垫的周边设置并且不直接定位在与超声刀接触区域相对的侧上。在另一方面，夹持臂垫的导电部分是可降解的或可磨损的，以防止与超声刀的接触中断导电夹持臂垫的其余导电部分的导电性。
在一个方面，本公开提供了一种与组合式超声/双极RF能量装置一起使用的夹持臂垫，其中夹持臂垫的一部分包括导电材料，而其他部分包括不导电材料。电极适于并被配置用于与组合式超声/RF能量装置一起使用并且能够在负载作用下偏转，其中电极是双极RF电路的一个极并且超声刀是双极RF电路的相反极。
在各个方面，可使用各种技术来制造夹持臂垫。一种技术包括在同一压模中模制导电材料和不导电材料的二次注塑工艺。该工艺有效地形成具有可用作双极RF电极的一部分和将用作电绝缘体的其他部分的单个夹持臂垫。另一种技术包括将金属元素超声冷喷涂嵌入聚合物(例如，聚四氟乙烯、PTFE)垫或基质中。另一种技术包括多种材料(例如，聚四氟乙烯、PTFE和掺杂型导电聚合物)的3D打印，将导电油墨或功能油墨打印/转印到夹持臂垫上。另一种技术包括使用化学气相沉积、物理气相沉积、溅射沉积、真空沉积、真空金属化或热喷涂将金属和导电材料(例如，石墨/碳)施加到夹持臂垫。另一种技术包括导电/负载的夹持臂垫电极通过具有微观无规取向和定位的粒子或宏观取向的结构(例如，织物、编织、长度受限纤维)的垫提供连续性。另一种技术包括使夹持臂垫的表面导电、提供磨穿式电极、3D打印、热喷涂、冷喷涂、涂层/油漆/环氧树脂、薄片/箔/线/膜缠绕或层压、真空金属化、打印/转移等技术。在另一种技术中，聚合物电极填充有导电材料。
在一个方面，端部执行器夹持臂包括固定的聚合物电极。图27示出了根据本公开的至少一个方面的夹持臂2500，该夹持臂包括用于支撑附接到夹钳2502的支架2504或冲压件的夹钳2502以及夹持臂垫2506。夹持臂垫2506包括导电垫2508和不导电垫2510。导电垫2508由导电聚合物制成并且用作双极RF电路的电极中的一个电极。夹钳2502和支架2504可由不锈钢制成并且使用任何合适的紧固技术附接，诸如例如焊接、激光焊接、钎焊、锡焊、压制以及其他紧固技术。导电垫2508可包括聚合物，诸如例如硅树脂、氟硅树脂、PTFE和类似材料。使用PTFE、硅树脂、填充有银颗粒的氟硅树脂、覆银铝、覆银铜、铜、镍，石墨、碳(无定形，短切纤维)、金、铂、不锈钢、铁或锌或其组合将导电垫2508包覆模制到支架2504上。
图28是沿图27中的截面28-28截取的剖视图，并且图29是沿图27中的截面29-29截取的剖视图。剖视图28-28和29-29示出了包括夹钳2502、支撑支架2504、导电垫2508和不导电垫2510的夹持臂2500。
图30是根据本公开的至少一个方面的包括夹钳2522、导电垫2524和不导电垫2526的夹持臂2520的另选具体实施的剖视图。导电垫2524由导电聚合物制成并且用作双极RF电路的电极中的一个电极。
图31是根据本公开的至少一个方面的包括夹钳2532、焊接到夹钳2532的支架2534或冲压件、导电垫2536和不导电垫2538的夹持臂2530的另选具体实施的剖视图。导电垫2536由导电聚合物制成并且用作双极RF电路的电极中的一个电极。导电垫2536包覆模制或冲压到支架2534上。
在一个方面，端部执行器夹持臂包括膜覆金属嵌件模制电极组件。在一个方面，可在金属(例如不锈钢)嵌件模制电极组件上提供膜。膜覆金属诸如不锈钢可以嵌件模制方式形成电极组件。嵌件模制电极上的膜可被蚀刻以形成微孔、狭缝、蜂窝以及其他图案，以能够传导RF能量以及切割部件的外围。可使用下文所述的IML/FIM(模内贴标/膜嵌件模制)工艺将膜形成于或结合在不锈钢电极上。可将带电膜电极放置在聚合物注塑模具中，以将聚合物模制到电极和膜的背面。电极适于并被配置用于与组合式超声/双极RF能量外科装置一起使用并且能够在负载作用下偏转，其中电极是双极RF电路的一个极并且超声刀是双极RF电路的相反极。
图32示出了根据本公开的至少一个方面的嵌件模制电极2540。嵌件模制电极2540包括导电元件2546、模制聚合物垫2548和膜2542涂层。诸如微孔、狭缝、蜂窝或类似特征部的特征部2550形成于膜2542中以允许RF能量通过。保持特征部2552也形成于膜2542上。膜2542的在聚合物垫2548的底部下方延伸的侧壁2558可围绕聚合物垫2548的底部折叠并与保持柱包覆模制。保持特征部2552被模制到由膜2542限定的孔2554中。尽管示出的两个嵌件模制电极2540之间具有间隙，但实际上，两个嵌件模制电极2540经由模制压力线对线2556配合。
导电元件2546可由诸如不锈钢或类似导电材料的导电金属制成。导电元件2546可为约0.010"厚，并且可在0.005"至0.015"的厚度范围内选择，并且可通过夯实或机加工形成。膜2544可为约0.001"至0.002"厚，并且可由聚酰亚胺、聚酯或类似材料制成。作为诸如柱的机械保持的替代，膜2544可直接结合到导电元件2546。一个示例包括厚度为0.002"的具有环氧粘合剂背衬的杜邦Pyralux HXC Kapton膜。
有利地，不粘表面防止组织粘连到嵌件模制电极2540。通过沿嵌件模制电极2540的整个长度设置在0.002"至0.004"范围内的间隙，不粘表面避免了相反电极的短路。由于嵌件模制电极2540的侧壁2558的覆盖，不粘表面使RF能量的横向传播最小化。此外，嵌件模制电极2540表现出结构牢固性并且提供比多层柔性电路更容易更稳健的电连接。
在一个方面，端部执行器包括用于组合式超声/双极RF能量外科装置的导电夹持臂和垫构造。在一个方面，本公开提供了一种包括导电或选择性导电薄膜、箔或层压件的夹持臂组件，这些导电或选择性导电薄膜、箔或层压件被施加到夹持臂组件、围绕夹持臂组件或在夹持臂组件上，以用作组合式超声/双极RF能量外科装置中的耐用“极”。此外，提供了算法、软件或逻辑来管理电短路的条件。电极适于并被配置用于与组合式超声/双极RF能量外科装置一起使用并且能够在负载作用下偏转，其中电极是双极RF电路的一个极并且超声刀是双极RF电路的相反极。
图33示出了根据本公开的至少一个方面的包括超声刀2562、夹持臂2564和包含导电膜2568的夹持臂垫2566的端部执行器2560。
图34示出了图33所示的夹持臂2564。夹持臂2564包括夹钳2570以支撑夹持臂垫2566。薄导电膜2568设置在夹持臂垫2566上，以形成双极RF电路的极中的一个极的电极。
图35是沿图34中的截面35-35截取的夹持臂2564的剖视图。夹钳2570可由金属诸如不锈钢制成。夹持臂垫2566可由不导电柔性材料诸如PTFE、硅树脂、高温聚合物或类似材料制成。导电膜2568或箔可由导电材料诸如钛、银、金、铝、锌及其任何合金(包括不锈钢)制成。
图36示出了根据本公开的至少一个方面的包括部分导电夹持臂垫2582的夹持臂2580。导电箔2584覆盖不导电垫2586的一部分。近侧端部2590处的不导电垫2588在夹持臂垫2582与超声刀之间设定间隙。
导电膜2568、箔或层压件的元件可包括例如单层薄导电材料，诸如金属(钛、银、金、锌、铝、镁、铁等及其合金或不锈钢)、镀覆金属(例如，铜上先镀镍，然后镀金)或大量填充有导电材料诸如金属粉末或填料的聚合物。优选地，其为具有选自0.001"至0.008"(0.025mm至0.20mm)范围内的厚度的生物相容的金属箔，诸如钛、银、金、锌或不锈钢。
膜2568、箔或层压件可包括覆盖上述薄导电材料的薄聚合物涂层、膜或层。这种涂层、膜或层是高电阻性的，即，它不是双极RF能量到相邻组织的有效导体。涂层可被穿孔以允许能量从电极递送到组织。
导电材料可被穿孔或包括穿过导电材料的全厚度的孔或窗，以最小化该层的热容(测试已表明，长的和/或厚的箔由于从治疗视线中去除热能而导致更长的横切时间)。这些穿孔、孔或窗还可允许将箔保持到其他部分或层。这些穿孔、孔或窗可在整个箔片材上形成图案，或可定位在治疗部位处或远离治疗部位，诸如例如仅在夹持臂的侧面上。
如果存在，则薄聚合物涂层、膜或层可被穿孔或包括全厚度的孔或窗，使得导电膜、箔或层压件与组织直接连通，用于将双极射频能量递送到组织。对于涂层，这些孔或窗可通过选择性涂覆或涂层去除来形成。
理想的是，导电膜2568、箔或层压件与通常由不锈钢制造的夹持臂结构直接接触。所得的导电路径于是实现构造的简单性，因为路径由必要的结构部件形成，即直接连接到夹持臂并且然后连接到导电膜、箔或层压件的支撑管或致动器。
在一个方面，导电膜2568、箔或层压件由相对柔软、高温、低磨损的聚合物或弹性体垫支撑，该垫由诸如PTFE、硅树脂、聚酰亚胺、高温热塑性塑料以及其他材料制成。该相对柔软的垫的顺应性允许宽范围的部件公差，以在夹钳完全闭合时沿其整个组织作用长度在夹钳与超声刀之间获得零或接近零的间隙，从而能够沿该长度密封和切割组织。顺应性还消除或大大衰减了当超声刀靠近导电层时可能发生的导电层的任何可听见的振动。
导电膜2568、箔或层压件可在其背侧/背部表面(即远离组织并朝向夹持臂的表面)上包括刚性至半刚性聚合物。该部件由能够注塑模制的聚合物或聚合物合金制成，并且通过膜嵌件模制(FIM)或模内贴标(IML)粘附到膜、箔或层压件。
在测试中，薄的不锈钢、铜或铝箔在操作中是安静的(没有“尖叫”或发出钝尖叫声)。薄的不锈钢、铜或铝箔提供了超声刀可作用的坚固表面。足够结实，使得原本会撕裂并用作差的垫材料的材料诸如硅橡胶是可用的并且不容易撕裂或裂开。
钳夹持表面的近侧部分可不包括导电膜、箔或层压件，因为钳的该区域首先接触刀并且更可能导致该区域中出现功率分流/短路。
在一个方面，本公开提供了一种用于激活包括双极RF能量的输出的短路减轻算法。
在短路发生在以下情况之后不向用户给出短路警报：为了激活而递送的能量超过阈值量(由此指示组织变薄但可能已接收到用于组织的密封、凝固的双极RF能量的足够剂量)，或已超过激活时间阈值(再次，由此指示组织变薄但可能已接收到足够剂量)，或已超过能量阈值和激活时间阈值两者。
制备膜覆不锈钢嵌件模制电极组件的工艺包括：蚀刻膜并形成用于传递RF能量的孔(微孔、槽或蜂窝)；切割电极部件的周边；如果需要，在不锈钢电极上形成膜/在将膜结合到不锈钢电极上；将带电膜和电极放置在聚合物注塑模具中；将聚合物模制到电极和膜的背面。
在各个方面，本公开提供了一种包括超声垫构型的组合式超声/双极RF能量外科装置。端部执行器包括压缩元件以限制端部执行器或其部件中的任一者中的热量产生。在一个方面，本公开提供了一种不对称分段超声支撑夹持臂垫，该夹持臂垫与被配置用于与组合式超声/RF能量装置一起使用的可移动RF电极配合接合。在另一方面，该不对称分段超声支撑夹持臂垫至少部分地延伸穿过RF电极。在另一方面，夹持臂垫的至少一个元件显著高于夹持臂垫的第二元件。在另一方面，第一夹持臂垫完全延伸穿过电极，并且第二夹持臂垫仅部分地延伸穿过电极。在另一方面，夹持臂垫的第一元件和夹持臂垫的第二元件由不同材料制成。更多背景技术材料可见于美国专利公布号2017/0164997号，该文献全文以引用方式并入本文。
在一个方面，端部执行器包括可偏转电极构型。在一个方面，本公开提供了一种至少部分地延伸穿过RF电极的分段超声支撑夹持臂垫。在另一方面，至少一个垫元件显著高于第二垫元件。在另一方面，第一垫元件整个地延伸穿过电极，并且第二垫元件部分地延伸穿过电极。在另一方面，第一垫元件和第二垫元件由不同材料制成。
在一个方面，本公开提供了一种包括破坏性部分和非破坏性部分的电极。图1至图9的描述以引用方式并入本文。结合图1至图9所示的夹持臂垫1010提供较大弹性(例如，PTFE)垫区域，同时仍然允许电极1004偏转。电极在近侧端部处固定到夹钳并且在远侧端部处自由偏转。因此，在整个本公开中，电极可被称为悬臂梁电极或可偏转电极。电极适于并被配置用于与组合式超声/双极RF能量外科装置一起使用并且能够在负载作用下偏转，其中电极是双极RF电路的一个极并且超声刀是双极RF电路的相反极。
在一个方面，端部执行器包括采用I形梁构型的夹持臂垫。提供I形梁形夹持臂垫(例如，特氟隆或PTFE)，使得夹持臂垫的底部滑入夹持臂中，并且夹持臂垫的顶部在电极上方滑动。夹持臂垫的顶部部分可被成形为经修改的鹅卵石形式，以增大与超声刀相对的侧面上的电极表面积。此构型同时在电极上方的夹持臂垫上的中线和凸缘处提供垫，以防止夹持臂垫与夹持臂分层。近侧硬(例如，聚酰亚胺)间隙设定垫从后方(近侧端部)滑入以提供间隙设置结构和“插塞”，从而将夹持臂垫保持在适当位置。
图37至图39示出了根据本公开的至少一个方面的夹持臂1990，该夹持臂包括被构造用于与包括夹钳1994、超声刀(未示出)和电极1996的端部执行器一起使用的I形梁形夹持臂垫1992。夹持臂垫1992具有I形梁构型，该构型包括由中间部分2002分开的顶部横向部分1998和底部横向部分2000以限定为“I”的横截面形状。电极1996设置在I形梁形夹持臂垫1992的顶部横向部分1998和底部横向部分2000之间。电极1996在近侧端部处固定到夹钳1994并且在远侧端部处自由偏转。因此，在整个本公开中，电极1996可被称为悬臂梁电极或可偏转电极。夹钳1994限定纵向槽2010，以可滑动地接纳穿过其的I形梁形夹持臂垫1992的底部横向部分1998、2000以及中间部分2002的一部分。
图38是夹持臂1990的俯视图，示出了从电极1996上方观察的夹持臂垫1992。图39是电极1996的俯视图，示出了用于将夹持臂垫1992可滑动地接纳在其中的纵向槽2010。参考图38至图39，夹持臂垫1992的I形梁段的顶部部分1998(被称为凸缘)定位在电极1996上方，以防止夹持臂垫1992与夹钳1994分层。在此视图中还示出了用于在电极1996与超声刀(未示出)之间设定间隙的硬耐磨间隙设定垫2004。通过在焊接点2008处将可偏转电极1996的近侧端部2006焊接到夹钳1994，将电极1996固定地附接到夹钳1994。可采用其他附接技术，诸如激光焊接、钎焊、锡焊、压制以及其他紧固技术。
图40A至图40C示出了根据本公开的至少一个方面的组装图37至图39所示的夹持臂1990的方法。在图40A中，电极1996在焊接点2008处焊接到夹钳1994的近侧端部2006。在图40B中，夹持臂垫1992可滑动地插入纵向槽2010中。在图40C中，用于设定间隙的硬耐磨间隙设定垫2004可滑动地插入夹钳1994中。
结合图37至图40C描述的夹持臂1990提供在夹持在组织上时偏转的电极1996。消除了夹持臂垫1992的段之间的组织积聚点并且最小化了电极1996的分层。夹持臂1990还消除了小间隙设定垫并且易于制造。
在一个方面，端部执行器包括交互电极凹陷部和超声刀支撑特征部。图41至图43示出了根据本公开的至少一个方面的端部执行器2020，该端部执行器包括在与超声刀2024的重叠位置限定凹陷部2030的电极2026，以最小化超声刀2024与电极2026之间的冲击。图41是根据本公开的至少一个方面的包括夹持臂2022、超声刀2024、电极2026和重聚合物支撑垫2028(例如，聚酰胺垫)的端部执行器2020的剖视图。图42是端部执行器2020的剖视图，其中重聚合物支撑垫2028磨损并且夹持臂2022与超声刀2024之间夹持有组织2032。在夹持状态下，电极2026与超声刀2024基本上齐平。图43是端部执行器2020的放大视图。在完全夹持状态下，电极2026与超声刀2024基本上齐平。当超声刀2024搁置在由重聚合物支撑垫2028限定的凹陷部2030中时，由电极2026的顶部限定的平面2034与当超声刀搁置在由较重聚合物支撑垫2028限定的凹陷部2030内时由超声刀2024的底部限定的平面2036基本上齐平或水平。
现在参考图41至图43，沿电极2026的中心线(CL)，电极2026限定凹陷部2029并且重聚合物支撑垫2028限定对应于超声刀2024的位置的集成式凹陷部2030以最小化电极2026和超声刀2024上的相互作用。这些凹陷部2030的位置可与不会因与超声刀2024接触而经受损坏的较重聚合物支撑垫2028的位置重合。以此方式，电极2026在以完全夹持状态夹持时可与超声刀2024基本上齐平，但不与超声刀2024发生金属接触。可使用在凹陷区域内限定的另外的孔将重聚合物支撑垫2028热熔或固定到电极凹陷部2030。电极适于并被配置用于与组合式超声/RF能量装置一起使用并且能够在负载作用下偏转，其中电极是双极RF电路的一个极并且超声刀是双极RF电路的相反极。
在一个方面，端部执行器包括聚酰亚胺前垫。图44至图45示出了根据本公开的至少一个方面的夹持臂2040，该夹持臂包括夹钳2042、与可移动浮动间隙设定垫2046组合的静止间隙设定垫2044。此构型提供复合布置以产生超声刀压力，同时还在电极2048与超声刀之间设定最小间隙。电极2048适于并被配置用于与组合式超声/RF能量装置一起使用并且能够在负载作用下偏转，其中电极是双极RF电路的一个极并且超声刀是双极RF电路的相反极。
图44是夹持臂2040的俯视图，示出了静止间隙设定垫2044和可移动浮动间隙设定垫2046。图45是夹持臂2040的侧视图，示出了夹钳2042、静止间隙设定垫2044、可移动浮动间隙设定垫2046、电极2048和夹持臂垫2050。最远侧2052的静止垫2044以与夹持臂垫2050类似的方式附接到夹钳2042。最远侧2052的静止间隙设定垫2044将改善末端压力/抓持，并且由于静止间隙设定垫2044烧穿而减小电极2048与超声刀短路的可能性。
图46至图47示出了根据本公开的至少一个方面的另选夹持臂2060，该夹持臂包括夹钳2074、位于远侧端部2062处的静止间隙设定垫2064、静止夹持臂垫2066以及位于近侧端部2068处的可移动浮动间隙设定垫2070。夹持臂2060还包括电极2072。
在一个方面，端部执行器包括具有齿的可偏转/悬臂式电极。由于超声刀的光滑性质，在超声装置中的组织保持可能是困难的。可添加另外的抓握特征部以增大组织抓握力。电极适于并被配置用于与组合式超声/双极RF能量外科装置一起使用并且能够在负载作用下偏转，其中电极是双极RF电路的一个极并且超声刀是双极RF电路的相反极。
图48至图49示出了根据本公开的至少一个方面的采用包括小齿的电极的组合式超声/双极RF能量外科装置。可添加电极齿以实现组织保持。可将穿过电极的齿添加到夹钳中。此构型相对容易实施并且在超声装置中提供更好的组织保持。在一个方面，本公开提供了一种包括超声刀和用于切割并密封组织的RF电极的外科装置，其中RF电极被实施为柔性构件并且其中柔性电极包括有利于组织抓持功能的多个齿。在另一方面，本公开提供了一种包括超声刀和用于切割并密封组织的RF电极的外科装置，其中RF电极被实施为柔性构件并且其中刚性可移动钳包括有利于组织抓持功能的突出穿过柔性电极的多个齿。
图48示出了根据本公开的至少一个方面的包括夹持臂2082、超声刀2084、包括多个齿2088的电极2086、柔韧夹持臂垫2090和硬间隙设定垫2092、2093的端部执行器2080。夹持臂2082包括能够绕枢转点2096枢转地移动的夹钳2094。电极2086在近侧端部处固定到夹钳2094并且在远侧端部处自由偏转。因此，在整个本公开中，电极2086可被称为悬臂梁电极或可偏转电极。电极2086适于并被配置用于与组合式超声/双极RF能量外科装置一起使用并且能够在负载作用下偏转，其中电极2086是双极RF电路的一个极并且超声刀2084是双极RF电路的相反极。
图49示出了根据本公开的至少一个方面的包括夹持臂2102、超声刀2104、电极2106、柔韧夹持臂垫2110和硬间隙设定垫2112、2113的端部执行器2100。夹持臂2102包括具有延伸穿过电极2106的齿2108的夹钳2114。夹钳2114能够围绕枢转点枢转地移动。电极2106在近侧端部处固定到夹钳2114并且在远侧端部处自由偏转。因此，在整个本公开中，电极2106可被称为悬臂梁电极或可偏转电极。
在一个方面，端部执行器包括超声可重新加载式电极子组件。图50至图57示出了根据本公开的至少一个方面的夹持臂2120，该夹持臂包括结合有包括齿2123的夹持臂垫2126的可重新加载式电极2122。可重新加载式电极2122针对电极通常遇到的挑战(诸如磨损、组织积聚和制造困难)提供了有利的解决方案。夹持臂2120包括使夹持臂2120能够枢转地打开和闭合的枢转点2121。电极2122适于并被配置用于与组合式超声/双极RF能量外科装置一起使用并且能够在负载作用下偏转，其中电极2122是双极RF电路的一个极并且超声刀是双极RF电路的相反极。
图50示出了根据本公开的至少一个方面的可重新加载式电极2122和夹持臂垫2126。图51示出了包括位于夹钳2127内的可重新加载式电极2122和夹持臂垫2126的夹持臂2120。硬耐磨间隙垫2125、2129设置在可重新加载式电极2122上或附近，以在可重新加载式电极2122与超声刀(未示出)之间设定间隙。可重新加载式电极2122包括臂2124，该臂由弯曲成可重新加载到端部执行器的夹持臂2120中的弹簧的金属片延长件形成。夹持臂垫2126(特氟隆、PTFE)可被捕获在臂2124的弹簧形式2128中并保持，直到被加载到夹持臂2120中。可重新加载式电极2122的侧部2130向内弯曲以防止组织积聚夹持臂2120与臂2124之间。可重新加载式电极2122在近侧端部处固定到夹钳2127并且在远侧端部处自由偏转。因此，在整个本公开中，可重新加载式电极2122可被称为悬臂梁电极或可偏转电极。
图52和图53分别是正从夹钳2127的前部(远侧端部)可滑动地插入夹钳2127中的过程中的可重新加载式电极2122和夹持臂垫2126的侧视图和顶视图。臂2124从夹持臂2120的前部组装并且由将槽2134定位在夹钳2127中的弯曲突片2132保持。可压下突片2132以在规程期间更换可重新加载式电极2122和夹钳2127。可重新加载式电极2122包括与夹持臂2120中的凹坑2138交接的保持支腿2136。保持支腿2136定位夹持臂2120并保持夹持臂在操作期间不释放。由夹钳2127限定的槽2135接纳可重新加载式电极2122。组装过程的成本低于焊接，并且如果发现缺陷还允许对部件进行再利用。另选方面包括可重新加载式电极2122和夹持臂垫2126加载或重新加载到夹钳2127中的方向、夹紧臂垫2126的垫的形状和数量、近侧垫的构型以及电极保持支腿2136的构型。
尽管可重新加载式电极2122被描绘为从夹钳2127的前部(远侧端部)加载，但另选地，可重新加载式电极2122可从夹钳2127的后部(近侧端部)、侧面或顶部加载。夹持臂垫2126的形状和垫的数量可变化以适应具体临床任务。在此方面，近侧夹持臂垫2126位于夹持臂2120上。在可更换性方面中，近侧夹持臂垫2126可结合到重新加载侧上。电极保持支腿2136的数量和大小可变化。可使用除电极保持支腿2136之外的另一种保持特征部。
图54是插入夹钳2127的凹坑2138中的电极支腿2136和位于由夹钳2127和限定的槽2134中的弯曲突片2132的剖视图，并且图55是夹持臂凹坑2138的详细视图。图56示出了如何通过按压弯曲突片2132来释放臂2124。图57是形成为冲压部件的可重新加载式电极2122和臂2124的详细视图，示出了金属片的延伸件以及尺寸和构造被设置成接纳从夹持臂垫2126突出的齿2123的孔口2142、尺寸和构造被设置成接纳硬耐磨间隙垫2125的孔口2144以及尺寸和构造被设置成接纳硬耐磨间隙垫2129的孔口2146。
可重新加载式电极2122提供若干优点和有益效果，包括防止可重新加载式电极2122与超声刀2104短路，克服由于聚合物(例如，特氟隆、PTFE)夹持臂垫2126的磨损而施加不足的组织压力，改进末端抓持，减少组织缠结和组织粘连，减少可更换电极2124与夹持臂2120之间的组织积聚，防止可更换电极2124与夹持臂2120分层，改善可制造性，和/或改善可靠性/使用寿命。
在一个方面，端部执行器包括补充垫构型。本公开提供了一种被构造用于与组合式超声/双极(RF)电外科器械一起使用的端部执行器。该端部执行器在组合式超声/双极RF能量装置的双极RF电极与超声刀之间保持一致的间隙，其中超声刀是双极RF电路的一个极并且夹持臂是双极RF电路的相反极。在常规端部执行器构型中，双极RF电极与超声刀之间的间隙由在外科规程期间将经受磨损的柔软聚合物(例如，PTFE)夹持臂垫来设定。当聚合物垫磨穿时，存在的风险是超声刀可接触电极，从而导致超声波中断或电极与超声刀短路。电极适于并被配置用于与组合式超声/双极RF能量外科装置一起使用并且能够在负载作用下偏转，其中电极是双极RF电路的一个极并且超声刀是双极RF电路的相反极。
在一个方面，本公开提供了一种结合了固定到夹持臂的RF电极的端部执行器。该电极包括接触超声刀以设定刀-电极间隙的耐磨不导电垫。这些耐磨间隙设定垫也对施加到超声刀的夹持力反应。电极限定一系列孔，柔性聚合物(特氟隆/PTFE)夹持臂垫突出穿过这些孔并接触处于夹持位置的超声刀。柔性聚合物夹持臂垫由定位在夹持臂垫与夹持臂之间的弹簧元件支撑。弹簧元件保持夹持臂垫与超声刀之间的一致接触。随着柔性聚合物夹持臂垫磨损，用弹簧推动更多材料穿过电极，以在组合式超声/双极RF能量装置的整个寿命期间将夹持臂垫维持为超声刀接触。弹簧可以是压缩弹簧、片簧或弹性体以及其他类型的弹簧。
图58至图60示出了根据本公开的至少一个方面的包括超声刀2152和夹持臂2154的端部执行器2150，该夹持臂包括弹簧加载式夹持臂垫2156。图58是端部执行器的透视图，图59是端部执行器2150的剖视图，并且图60是端部执行器2150的分解图。夹持臂2154还包括夹钳2158和夹持臂垫齿2155组件，该夹钳限定尺寸和构造被设置成在其中接纳电极2162的孔口2160。电极2162还限定尺寸和构造被设置成接纳穿过其的夹持臂垫齿2155的孔口2164。多个弹簧2168位于对应的凸台2170中。背板2172锁定到夹钳2158并且压缩弹簧2168以将负载施加到夹持臂垫2155。施加到夹持臂垫2155的负载使弹簧加载式夹持臂垫2156随着弹簧加载式夹持臂垫2156在使用期间磨损而保持与超声刀2152的接触。电极2162适于并被配置用于与组合式超声/双极RF能量外科装置一起使用并且能够在负载作用下偏转，其中电极2162是双极RF电路的一个极并且超声刀2152是双极RF电路的相反极。
图61示出了根据本公开的至少一个方面的弹簧加载式夹持臂垫2180。夹持臂垫2180包括夹钳2182、电极2184、柔性夹持臂垫2186(例如，PTFE)和硬间隙设定垫2188(例如，聚酰亚胺)。将弹簧力施加到夹持臂垫2186以相对于电极2184移动夹持臂垫2186，同时电极2184保持固定。
图62示出了根据本公开的至少一个方面的包括弹簧加载式夹持臂垫2192的夹持臂2190。夹持臂2190还包括背板2194和位于夹钳2198与背板2200之间的多个弹簧2196。夹持臂垫2192的基部固定到背板2194，并且夹持臂垫2192的突出部2202(例如，齿)延伸穿过由电极2206限定的孔口2204。在一个方面，夹持臂2190还包括由硬耐磨材料制成的多个间隙设定垫2208以在电极2206与超声刀(未示出)之间设定间隙。在一个方面，弹簧加载式夹持臂垫2192由润滑的不粘柔性材料诸如PTFE制成，并且间隙设定垫2208由较硬耐磨材料诸如聚酰亚胺制成。
图63示出了根据本公开的至少一个方面的包括弹簧加载式夹持臂垫2212、电极2214和间隙设定垫2216的夹持臂2210。夹持臂垫2212中的切口2218限定用作弹簧元件的突出部2215。夹持臂垫2212的基部固定到电极2214的背部，并且夹持臂垫2212的突出部2211(例如，齿)延伸穿过由电极2214限定的孔口2213。在一个方面，弹簧加载式夹持臂垫2212由润滑的不粘柔性材料诸如PTFE制成，并且间隙设定垫2216由较硬耐磨材料诸如聚酰亚胺制成。
图64示出了根据本公开的至少一个方面的包括由弹性体弹簧2224均匀地升高的弹簧加载式夹持臂垫2222的夹持臂2220。弹性体弹簧2224可由橡胶、泡沫或其他弹性材料形成。弹性体弹簧2224定位在硬塑料间隙设定垫2226上方。在一个方面，弹簧加载式夹持臂垫2222由润滑的不粘柔性材料诸如PTFE制成，并且间隙设定垫2226由较硬耐磨材料诸如聚酰亚胺制成。
图65示出了根据本公开的至少一个方面的包括弹簧加载式夹持臂垫2232的夹持臂2230。弹簧2234将负载施加到夹持臂垫2232，使得夹持臂垫2232在外科规程期间维持与超声刀的紧密接触。
在一个方面，端部执行器包括浮动夹持臂垫。图66至图82示出了根据本公开的至少一个方面的端部执行器2240，该端部执行器包括浮动夹持臂2242、2244的第一构型和第二构型与超声刀2246的组合。端部执行器2240的构型包括由弹性/超弹性块2252、2254支撑的夹持臂垫单元2248、2250和用于与超声刀2246组合使用的电极2255，以减少夹持臂垫单元2248、2250的磨损并增大组织体积较高的位置处的切割速度。弹性/超弹性块2252、2254可形成为单件或多个单个件2250。单个夹持臂垫单元2248、2250可抵靠弹性/超弹性块2254偏置，以容纳浮动夹持臂2244与超声刀2246之间的高压区域。电极2255适于并被配置用于与组合式超声/双极RF能量外科装置一起使用并且能够在负载作用下偏转，其中电极2255是双极RF电路的一个极并且超声刀2246是双极RF电路的相反极。
在一个方面，浮动夹持臂2242、2244包括多个单个夹持臂垫单元2248、2250，其中单个夹持臂垫单元2248、2250中的每一者抵靠附接到浮动夹持臂2242、2244的单件式块2252或多件式块2254座置。单个夹持臂垫单元2248、2250中的每一者包括套环2264，以限制单个夹持臂垫单元2248、2250沿电极2255的通道并且在夹钳2260与电极2255之间的移动。单件式块2252或多件式块2254由弹性或超弹性材料制成，以提供弹簧状特性，用于平衡浮动夹持臂2242、2244的侧面与超声刀2246的侧面之间的压力。材料可以是多孔的、橡胶或类似的电绝缘材料。可压缩块2252、2254使单个夹持臂垫单元2248、2250能够浮动。在组织体积较高的位置，推动块2252、2254以被单个夹持臂垫单元2248、2250压缩，从而在组织上引起较高压力以增大该区域中的切割速度并增强止血。受到压缩的块2252、2254将继续抵靠组织往回推动单个夹持臂垫单元2248、2250，直到组织被完全切割。
图67是夹钳2260、电极2255和超声刀2246部件的分解图，这些超声刀部件对于浮动夹持臂2242、2244的第一构型或第二构型中的任一者是通用的。
图68示出了浮动夹持臂2242的第一构型的夹持臂垫单元2248和单件式弹性/超弹性块2252部件。单件式弹性/超弹性块2252支撑夹持臂垫单元2248，并且可由多孔的、橡胶或类似的电绝缘材料制成。
图69示出了浮动夹持臂2244的第二构型的夹持臂垫单元2250和多件式弹性/超弹性块2254部件。多件式弹性/超弹性块2254中的每一者支撑夹持臂垫单元2250中的每一者，并且可由多孔的、橡胶或类似的电绝缘材料制成。多件式弹性/超弹性块2254中的每一者结合到每个单个夹持臂垫单元2250。以下将更详细描述这些构型中的每一种。
图70示出了根据本公开的至少一个方面的突出穿过由电极2255限定的孔口2262但不彼此接触的夹持臂垫单元2250布局。
图71示出了由电极2255限定的尺寸和构造被设置成接纳夹持臂垫单元2248、2250中的任一者的孔口2262。孔口2262限定通道2266以引导单个夹持臂垫单元2248、2250的移动。单个夹持臂垫单元2248、2250上的套环2264约束单个夹持臂垫单元2248、2250在浮动夹持臂2242、2244与电极2255之间的移动，并且防止单个夹持臂垫单元2248、2250从电极2255逸出。
图72是包括单件式弹性/超弹性块2252的第一构型夹持臂2248的组装图。图73是根据本公开的至少一个方面的包括浮动夹持臂2242和超声刀2246的端部执行器2270的第一构型的剖视图。浮动夹持臂2242包括夹钳2260、穿过由电极2255限定的孔口2262定位并由单件式弹性/超弹性块2252支撑的多个单个夹持臂垫单元2248。多个单个夹持臂垫单元2248接合位于超声刀2246与电极2255之间的组织2268。
图74是根据本公开的至少一个方面的包括浮动夹持臂2244和超声刀2246的端部执行器2280的第二构型的剖视图。浮动夹持臂2244包括夹钳2261、穿过由电极2255限定的孔口2262定位并由多件式弹性/超弹性块2254支撑的多个单个夹持臂垫单元2250。多个单个夹持臂垫单元2250接合位于超声刀2246与电极2255之间的组织2268。
图75示出了根据本公开的至少一个方面的组装包括浮动夹持臂2242和超声刀2246的第一构型端部执行器2292的方法2290。第一子组件2296包括组装到电极2255的单个夹持臂垫单元2248。第二子组件2298包括通过焊接或螺钉组装到夹钳2260的单件式弹性/超弹性块2252。第三子组件2300包括组装到第二子组件2298的第一子组件2296，以得到完全组装的浮动夹持臂2242。通过将超声刀2246添加到第三子组件2300来完成端部执行器2292。
图76示出了根据图75组装的端部执行器2292。如图77所示，在组织2268的体积较高的位置，单件式弹性/超弹性块2252被单个夹持臂垫单元2248压缩，从而引起组织2268上的较高压力以增大该区域的切割速度，进而可能增强止血。受到压缩的单件式弹性/超弹性块2252将继续抵靠组织2268推动单个夹持臂垫单元2248，直到组织2268被完全切割，并且单个夹持臂垫单元2248将恢复到其初始位置。
图78示出了位置2249，在该位置，当超声刀2246直接接触单个夹持臂垫单元2248时，单件式弹性/超弹性块2252可平衡超声刀2246与单个夹持臂垫单元2248之间的压力，从而减少单个夹持臂垫单元2248的磨损。
图79示出了根据本公开的至少一个方面的组装包括浮动夹持臂2244和超声刀2246的第二构型端部执行器2312的方法2310。第一子组件2316包括组装到电极2255的单个夹持臂垫单元2250和多件式弹性/超弹性块2254。第二子组件2318包括通过任何合适的紧固技术(诸如焊接、激光焊接、钎焊、锡焊、压制以及其他紧固技术，诸如螺钉)组装到夹钳2260的第一子组件2316。通过将超声刀2246添加到第二子组件2318来完成端部执行器2312。
图80示出了根据图79组装的端部执行器2312。如图81所示，在组织2268的体积较高的位置，推动多件式弹性/超弹性块2254以被单个夹持臂垫单元2250压缩，从而引起组织2268上的较高压力以增大该区域的切割速度，进而可能增强止血。受到压缩的多件式弹性/超弹性块2254将继续抵靠组织2268推动单个夹持臂垫单元2250，直到组织2268被完全切割，并且单个夹持臂垫单元2250将恢复到其初始位置。
图82示出了位置2251，在该位置，当超声刀2246直接接触单个夹持臂垫单元2250时，多件式弹性/超弹性块2254可平衡超声刀2246与单个夹持臂垫单元2250之间的压力，从而减少单个夹持臂垫单元2250的磨损。
在一个方面，端部执行器包括可选择性地展开的齿。在组合式超声/双极RF能量装置中，可能希望具有可选择性地展开的齿以有利于不同的能量模态。这能够实现多功能，而无需进行重大的构型权衡。在缩回构型中，超声垫齿提供组织与电极之间的增大表面积接触并且对于施加单RF能量模态进行密封组织是理想的。在完全展开构型中，超声垫齿提供低风险的超声刀与电极之间的金属-金属接触并且对于组织操纵和施加单超声波能量模态是理想的。在部分展开构型中，超声垫齿非常适合同时施加超声和RF能量模态。电极适于并被配置用于与组合式超声/双极RF能量外科装置一起使用并且能够在负载作用下偏转，其中电极是双极RF电路的一个极并且超声刀是双极RF电路的相反极。
图83示出了根据本公开的至少一个方面的包括可选择性展开的垫齿2330的夹持臂2320。夹持臂2320包括夹钳2322、电极2324、由电极2324限定的多个孔口2326和驱动突片2328。由电极2324限定的多个孔口2326包括可展开的垫齿2330。驱动突片2328用于展开或缩回可展开的垫齿2330，使得可展开的垫齿2330在驱动突片2328缩回时缩回并且可展开的垫齿2330在驱动突片2328前进时展开。在另一方面，此构型可反向，使得可展开的垫齿2330在驱动突片2328缩回时展开并且可展开的垫齿2330在驱动片2328前进时缩回。在一个方面，垫齿插塞2330由如特氟隆/PTFE等润滑柔性聚合物材料制成。
类似于钉筒，夹持臂2320组件通过将驱动突片2328嵌套到夹钳2322的通道中而形成。可选择性地展开的垫齿2330放置在驱动器2332(图84至图85)上并且通过与电极2324干涉而处于子组件中。为了完成子组件，电极2324可使用任何合适的紧固技术(诸如焊接、激光焊接、钎焊、锡焊、压制以及其他紧固技术)固定地附接到夹钳2322。在夹钳2322内平移驱动器2332使得可选择性地展开的垫齿2330相对于电极2324的表面升高或降低。
图84是根据本公开的至少一个方面的图83所示的夹持臂2320的剖视图，该夹持臂包括以缩回构型定位在孔口2236内的可选择性展开的垫齿2330。当驱动器2332朝近侧2334缩回时，如图所示，可选择性地展开的垫齿2330在电极2324下方缩回。
图85是根据本公开的至少一个方面的图83所示的夹持臂2320的剖视图，该夹持臂包括处于展开构型的可选择性展开的垫齿2330。当驱动器2332朝远侧2336前进时，如图所示，可选择性地展开的垫齿2330在电极2324上方展开。
图86是根据本公开的至少一个方面的图83所示的夹持臂2320的详细剖视图，该夹持臂包括处于缩回构型的可选择性展开的垫齿2330。可选择性地展开的垫齿2330中的每一者具有大于由电极2324限定的孔口2326的肩部2338，以将可选择性地展开的垫齿2330保持在夹钳2322内。可选择性地展开的垫齿2330的几何形状2340的尺寸和构造被设置成穿过孔口2326展开。干涉几何形状2342可以是圆形的(如图所示)、成角度的或其组合，以优化用于展开可选择性地展开的垫齿2330的期望的力曲线。本领域已知的另外柄部机构(推/拉杆、附加管驱动)可用于致动驱动器2332。
在一个方面，端部执行器包括具有散热冷却机构的夹持臂垫。在一个方面，夹持臂垫包括散热块，以通过减少夹持臂垫上的热积聚来保护超声装置的夹持臂垫。可使用各种技术来实现夹持臂垫上的热积聚减少。电极适于并被配置用于与组合式超声/双极RF能量外科装置一起使用并且能够在负载作用下偏转，其中电极是双极RF电路的一个极并且超声刀是双极RF电路的相反极。
图87A示出了根据本公开的至少一个方面的被配置为能够接纳如图87B至87C所示的散热材料块2356的端部执行器2350。端部执行器2350包括夹钳2352和超声刀2354。图87B示出了图87A所示的端部执行器2350的一个示例，其中散热材料块2356添加到或以其他方式固定地附接到由金属夹钳2352支撑的夹持臂垫2358。图87C示出了具有磨损的夹持臂垫2359的散热材料块2356。散热材料块2356减少热积聚并且将保护夹持臂垫2359不会由于与超声刀2354接触而过热。
图88A示出了根据本公开的至少一个方面的包括金属夹钳2362和超声刀2364的端部执行器2360，其中金属夹钳的至少一些部分由散热材料制成。在一个方面，整个金属夹钳2362由散热材料制成并且紧密固定到图88B中示出的夹持臂垫2366和图88C中示出的另选夹持臂垫2368。散热材料可包括具有高导热特性和高比热的材料中的任一种或两种，并且形成大表面积特征以随着由于与超声刀2364接触而导致热量积聚在夹持臂垫2366、2368中而增强热扩散。
结合图87A至87C和88A至88C，散热材料应具有高导热性能，诸如例如铝、铜及其合金或其他类似材料。此外，散热材料在散热部件上形成大表面积以加速热扩散或耗散。最常见的散热材料是铝合金。铝合金1050具有229W/m·K的较高热导率值，但机械性能柔软。可使用铝合金6060(低应力)、6061、6063，其中热导率值为分别为166W/m·K和201W/m·K。
图89示出了图87A至87C和88A至图88C中所述的端部执行器的部件2350、2360。
图90示出了根据本公开的至少一个方面的包括用于增大散热器部件的表面积的翅片2369的一种散热结构2367。
图91示出了根据本公开的至少一个方面的包括用于增大散热器部件的表面积的孔2372的另一种散热结构2370。
在各个方面，本公开提供了组合式超声/双极RF能量外科装置和系统。各种形式均涉及用于具有被配置用于在外科规程期间执行组织治疗、解剖、切割和/或凝固的超声和/或电外科(RF)端部执行器的外科器械的用户界面。在一种形式中，为组合式超声和电外科器械提供用户界面，该外科器械可被配置用于开放式外科规程，但也应用于其他类型的外科规程，诸如微创腹腔镜、目视或胸腔镜规程，例如手持式或机器人辅助规程中的非侵入式内窥镜规程。通过同时地、独立地、顺序地或其组合选择性地应用多种能量模态来实现多功能性。例如，可通过同时地、独立地、顺序地或其组合选择性地使用超声和电外科能量(例如，单极或双极RF能量)来实现多功能性。
在一个方面，本公开提供了一种用于一种设备的用户界面，该设备包括超声刀和具有可偏转RF电极的夹持臂，使得超声刀和可偏转RF电极协作以通过包括RF电极的设备的夹持机构与相关联的超声刀的协作来执行组织的密封、切割和夹持。夹持机构包括与超声刀协作以抓持其间的组织的枢转夹持臂。该夹持臂优选地具有夹持组织垫(也被称为“夹持臂垫”)，该夹持组织垫具有多个轴向间隔开的夹持齿、节段、元件或单个单元，这些夹持齿、节段、元件或单个单元与端部执行器的超声刀协作以实现对组织的期望的密封和切割效果，同时有利于在外科规程期间抓持和夹持组织。
在一个方面，本文所述的端部执行器包括电极。在其他方面，本文所述的端部执行器包括电极的另选形式，以提供RF能量到组织的柔性联接、适应垫磨损/变薄、最小化过量热的产生(低摩擦系数、压力)、最小化火花的产生、最小化由于电短路引起的中断或其他们的组合。电极在近侧端部处固定到夹钳并且在远侧端部处自由偏转。因此，在整个本公开中，电极可被称为悬臂梁电极或可偏转电极。
在其他方面，本文所述的端部执行器包括夹持臂机构，该夹持臂机构被配置为能够在垫与超声刀之间施加高压力以抓持和密封组织、最大化夹持臂电极在受限或困难场景下接触组织的可能性，受限或困难场景诸如例如薄组织、处于横向张力下的组织、组织隆起/垂直张力，尤其是隆起组织远离夹持臂时。
在其他方面，本文所述的端部执行器被配置为能够平衡电极之间的表面积/电流密度的匹配，平衡和最小化来自组织界面的热传导，诸如例如影响损伤形成和对称性、循环时间、残余热能。在其他方面，本文所述的端部执行器被配置为能够最小化粘连、组织粘附(最小化锚定点)并且可包括小聚酰亚胺垫。
在各个方面，本公开提供了一种外科装置，该外科装置被配置为能够将至少两种能量类型(例如，超声、单极RF、双极RF、微波或不可逆电穿孔[IRE])递送到组织。该外科装置包括用于激活能量的第一激活按钮开关、用于为激活按钮开关选择能量模式的第二按钮开关。第二按钮开关连接到使用至少一个输入参数来定义能量模式的电路。可通过到发生器的连接或通过软件更新来远程修改输入参数。
在一个方面，能量模式中的至少一个能量模式是RF能量和超声能量的同时混合，并且输入参数表示RF能量和超声能量的占空比。
在一个方面，第二按钮开关可配置为能够从预定义模式列表中选择，并且列表中的模式数目由用户定义的第二输入参数定义。
在一个方面，输入参数是占空比、电压、频率、脉冲宽度或电流。
在一个方面，该装置还包括装置的部分内的所选能量模式在术野中的视觉指示器。
在一个方面，第二按钮开关是与端部执行器闭合触发器分开的控制器。
在一个方面，第二按钮开关被配置为能够致动闭合触发器的第二阶段。闭合触发器在闭合方向上的第一阶段是致动端部执行器。
在一个方面，能量模式中的至少一个能量模式选自超声波、RF双极、RF单极、微波或IRE。
在一个方面，能量模式中的至少一个能量模式选自超声波、RF双极、RF单极、微波或IRE并且被配置为能够以预定义占空比或脉冲算法来施加。
在一个方面，能量模式中的至少一个能量模式选自以下类型的能量中的两种或更多种的顺序施加：超声、RF双极、RF单极、微波或IRE。
在一个方面，能量模式中的至少一个能量模式是以下类型的能量中的两种或更多种的同时混合：超声、RF双极、RF单极、微波和IRE。
在一个方面，能量模式中的至少一个能量模式是以下类型的能量中的两种或更多种的同时混合：超声、RF双极、RF单极、微波和IRE，然后是上述能量中的一种或多种。
在一个方面，能量模式中的至少一个能量模式是以下类型的能量中的一者：超声、RF双极、RF单极、微波和IRE，然后是上述能量中的两种或多种的同时混合。
在一个方面，能量模式中的至少一个能量模式是规程或组织特定的预定义算法。
在一个方面，能量模式中的至少一个能量模式编译自所学习的外科行为或活动。
在一个方面，输入参数是以下中的至少一者：能量类型、占空比、电压、频率、脉冲宽度、电流、阻抗限制、激活时间或能量混合。
在一个方面，第二按钮开关可配置为能够从预定义模式列表中选择，并且列表中的模式数目是预定义的或由用户定义的第二输入参数定义。
在一个方面，通过对发生器进行软件更新使上述能量模式对用户可用。
在一个方面，通过对装置进行软件更新使上述能量模式对用户可用。
在一个方面，通过网络、云或人工传输使用户的优选选择对多个发生器可用。
在一个方面，该装置还包括装置的部分内的所选能量模式在术野中的视觉指示器。
如本文所用，按钮开关可以是具有连接到外部电路的一组或多组电触点的手动、机械或电操作的机电装置。每组电触点可处于两种状态中的一种状态：“闭合”意味着触点接触并且电可在它们之间流动，或者“打开”意味着触点分离并且开关不导电。致动在这两种状态(打开或闭合)之间进行切换的机构可以是“交替动作”(将开关翻转为连续“开”或“关”)或“瞬时”(推动为“开”，而释放为“关”)类型。
在一个方面，本公开提供了一种组合式超声/双极RF能量外科装置，该外科装置在装置上包括模式选择和视觉反馈。随着外科装置演进并变得功能更强，可操作它们的专用模式的数目增加。在装置上增加额外的按钮开关以适应这些新的附加模式将使用户界面复杂化并且更难使用装置。因此，本公开提供了用于将不同模式指定给单个物理按钮开关的技术，这能够具有更多模式选择并且不增加外壳设计的复杂性(例如，不添加越来越多的按钮开关)。在一个方面，外壳是柄部或手枪式握把的形式。
随着更多专业模式变得可用，需要向使用外科装置的外科医生提供多种模式而不产生复杂的用户界面。外科医生希望能够从无菌区控制模式选择，而不是依赖发生器处的巡回护士。外科医生希望实时反馈，这样他们才有信心知道选择哪种模式。
图92示出了根据本公开的至少一个方面的外科装置100，该外科装置在装置100上包括模式选择按钮开关130。外科装置100包括限定手枪式握把形式的柄部104的外壳102。外壳102包括触发器106，当被挤压时，触发器被接纳到由柄部104限定的内部空间中。触发器106用于操作端部执行器110的夹持臂111部分。夹钳112能够围绕枢转点114枢转地移动。外壳102通过能够被旋钮122旋转的轴108联接到端部执行器110。
端部执行器110包括夹持臂111和超声刀116。夹持臂111包括夹钳112、电极118和夹持臂垫120。在一个方面，夹持臂垫120由不粘润滑材料制成，诸如PTFE或类似的四氟乙烯合成含氟聚合物。PTFE是疏水的、非润湿的、高密度的和耐高温的多用途材料并且具有不粘特性。夹持臂垫120是不导电的。相比之下，电极118由导电材料制成以递送电能，诸如单极RF、双极RF、微波或不可逆电穿孔(IRE)。电极118可包括由聚酰亚胺材料制成的间隙设定垫，并且在一个方面由以商品名VESPEL为人所知并且由杜邦公司制造的耐用高性能聚酰亚胺基塑料或者其他合适的聚酰亚胺、聚酰亚胺聚合物合金、或PET(聚对苯二甲酸乙二醇酯)、PEEK(聚醚醚酮)、PEKK(聚醚酮酮)聚合物合金制成。除非下文另有说明，否则下文所述的夹持臂垫和间隙垫由本段所述的材料制成。
电极118和超声刀116联接到发生器133。发生器133被配置为能够将RF、微波或IRE能量驱动到电极118。发生器133还被配置为能够驱动声学联接到超声刀116的超声换能器。在某些具体实施中，电极118是电路的一个极并且超声刀116是该电路的相反极。外壳102包括开关124以致动超声刀116。电路可容纳在外壳102中或者可驻留在发生器133中。外科装置100经由缆线131联接到发生器133。缆线131传导用于电外科功能和超声换能器的信号。
在各个方面，外科装置100被配置为能够将至少两种能量类型(例如，超声、单极RF、双极RF、微波或不可逆电穿孔[IRE])递送到位于夹持臂111与超声刀116之间的端部执行器110中的组织。外科装置100的外壳102包括用于激活能量的第一激活按钮开关126和用于为激活按钮开关选择能量模式的第二“模式”按钮开关130。第二按钮开关130连接到使用至少一个输入参数来定义能量模式的电路。可通过到发生器的连接或通过软件更新来远程修改输入参数。能量模式显示在用户界面128上。
在一个方面，外科器械100通过装置上方向选择器“模式”按钮开关130提供模式切换。用户可按下模式按钮开关130来切换不同的模式，并且用户界面128上的有色光指示所选模式。
根据本公开的各个方面，可通过按压“模式”按钮开关130来将不同操作模式分配给外科装置，其中每次按压或推动并保持模式按钮开关130时，外科装置100在显示在用户界面128上的可用模式之间切换。一旦选择了某个模式，发生器133将提供适当的发生器音调，并且外科装置100将在用户界面128上具有亮起的指示器以指示选择了哪种模式。
在图92所示的示例中，“模式”选择按钮开关130对称地放置在外壳102的两侧。这使得惯用右手和左手的外科医生都能够在不使用第二只手的情况下选择/切换模式。在该方面，“模式”选择按钮开关130可在许多不同方向上切换，这使得外科医生能够从选项列表中进行选择并且从无菌区远程导航更复杂的选择，而不必要求巡回人员在发生器133处进行调节。除了发生器133的音调之外，外科装置100的用户界面128上的亮起的指示器也给出外科医生关于选择了哪种模式的反馈。
图93A至图93C示出了根据本公开的至少一个方面的用于选择外科装置100的各种操作模式的三个选项。除了外科装置100的外壳102上的有色光用户界面128之外，用于模式选择的反馈通过发生器133的界面是可听的和/或可见的，在该界面，发生器133用语音宣布所选模式和/或在发生器133的屏幕上显示所选模式的描述。
图93A示出了第一模式选择选项132A，其中可向前136或向后134按压按钮开关130以使外科器械100在各种模式之间循环。
图93B示出了第二模式选择选项132B，其中向上140或向下138按压按钮开关130以使外科器械100在各种模式之间循环。
图93C示出了第三模式选择选项132C，其中向前136、向后134、向上149或向下138按压按钮开关130以使外科器械100在各种模式之间循环。
图94示出了根据本公开的至少一个方面的外科装置150，该外科装置在装置150的背面上包括模式选择按钮开关180。外科装置150包括限定手枪式握把形式的柄部154的外壳152。外壳152包括触发器156，当被挤压时，触发器被接纳到由柄部154限定的内部空间中。触发器156用于操作端部执行器160的夹持臂161部分。夹钳162能够围绕枢转点164枢转地移动。外壳152通过能够被旋钮172旋转的轴158联接到端部执行器160。
端部执行器160包括夹持臂161和超声刀166。夹持臂161包括夹钳162、电极168和夹持臂垫170。在一个方面，夹持臂垫170由不粘润滑材料制成，诸如PTFE或类似的四氟乙烯合成含氟聚合物。PTFE是疏水的、非润湿的、高密度的和耐高温的多用途材料并且具有不粘特性。夹持臂垫170是不导电的。相比之下，电极168由导电材料制成以递送电能，诸如单极RF、双极RF、微波或不可逆电穿孔(IRE)。电极168可包括由聚酰亚胺材料制成的间隙设定垫，并且在一个方面由以商品名VESPEL为人所知并且由杜邦公司制造的耐用高性能聚酰亚胺基塑料或者其他合适的聚酰亚胺、聚酰亚胺聚合物合金、或PET(聚对苯二甲酸乙二醇酯)、PEEK(聚醚醚酮)、PEKK(聚醚酮酮)聚合物合金制成。除非下文另有说明，否则下文所述的夹持臂垫和间隙垫由本段所述的材料制成。
电极168和超声刀166联接到发生器133。发生器133被配置为能够将RF、微波或IRE能量驱动到电极168。发生器133还被配置为能够驱动声学上联接到超声刀166的超声换能器。在某些具体实施中，电极168是电路的一个极并且超声刀166是该电路的相反极。外壳152包括开关174以致动超声刀166。电路可容纳在外壳152中或者可驻留在发生器133中。外科装置150经由缆线181联接到发生器133。缆线181传导用于电外科功能和超声换能器的信号。
在各个方面，外科装置100被配置为能够将至少两种能量类型(例如，超声、单极RF、双极RF、微波或不可逆电穿孔[IRE])递送到位于夹持臂111与超声刀116之间的端部执行器110中的组织。外科装置100的外壳102包括用于激活能量的第一激活按钮开关126和用于为激活按钮开关选择能量模式的第二“模式”按钮开关130。第二按钮开关130连接到使用至少一个输入参数来定义能量模式的电路。可通过到发生器的连接或通过软件更新来远程修改输入参数。能量模式显示在用户界面128上。
在一个方面，外科器械150通过装置上方向选择器“模式”按钮开关180提供模式切换。用户可按下模式按钮开关180来切换不同的模式，并且用户界面178上的有色光指示所选模式。
根据本公开的各个方面，可通过按压“模式”按钮开关180来将不同操作模式分配给外科装置，其中每次按压或推动并保持模式按钮开关180时，外科装置150在显示在用户界面178上的可用模式之间切换。一旦选择了某个模式，发生器133将提供适当的发生器音调，并且外科装置150将在用户界面178上具有亮起的指示器以指示选择了哪种模式。
在图94所示的示例中，“模式”选择按钮开关180放置在外壳150的背面。“模式”选择按钮开关180的位置超出外科医生握持外科装置150的手的触及范围，因此需要用第二只手来改变模式。这旨在防止意外激活。为了改变模式，外科医生必须使用自己的第二只手有意地按下模式按钮开关180。除了发生器的音调之外，外科装置150的用户界面178上的亮起的指示器也给出外科医生关于选择了哪种模式的反馈。
图95A示出了第一模式选择选项，其中随着模式按钮开关180被按下以在各种模式之间切换，有色光在用户界面178上指示所选模式。
图95B示出了第二模式选择选项，其中随着模式按钮开关180被按下以在各种模式之间切换，屏幕182指示所选模式(例如，LCD、电子墨水)。
图95C示出了第三模式选择选项，其中随着模式按钮开关180被按下以在各种模式之间切换，所标记的灯184指示所选模式。
图95D示出了第四模式选择选项，其中随着所标记的按钮开关186被按下以选择模式，当选择了所标记的按钮开关180时，它被点亮以指示所选模式。
在一个方面，本公开提供了一种包括通过触发器闭合进行能量激活的组合式超声/双极RF能量外科装置。随着更多功能被添加到先进的能量外科装置，附加的按钮开关或控件被添加到外科装置。附加的按钮开关或控件使得这些先进的能量外科装置复杂且难以使用。此外，当使用先进的能量外科装置来控制出血时，难以使用用户界面或难以获得的能力将在外科规程期间花费关键时间和注意力。
根据本公开，通过将触发器挤压经过第一闭合咔嗒声至第二激活咔嗒声并保持闭合直到能量递送被发生器中的电源停止，通过闭合触发器来激活单极RF能量或先进的双极RF能量。通过稍微释放并重新挤压触发器所需的次数，也可立即重新施加能量。
图96示出了根据本公开的至少一个方面的包括触发器196的激活机构的外科装置190。外科装置190包括限定手枪式握把形式的柄部194的外壳192。外壳192包括触发器196，当被挤压时，触发器被接纳到由柄部194限定的内部空间中。外壳192通过能够被旋钮202旋转的轴198联接到端部执行器。外科装置190经由缆线204联接到发生器206。缆线204传导用于电外科功能和超声换能器的信号。
触发器196被配置为能够操作端部执行器的夹持臂部分并触发电外科能量，因此取消了图92和图94所示的激活按钮开关126、176。触发器196闭合到第一听觉和触觉咔嗒声以闭合用于抓持组织的钳，并且进一步闭合到第二听觉和触觉咔嗒声以激活诸如单极或双极RF、微波或IRE能量的电外科能量。通过激活使用超声能量进行切割的前按钮开关来完成整个序列。
用于操作外科装置190的程序：将触发器196挤压到第一听觉和触觉咔嗒声；验证钳中的目标组织；通过将触发器196进一步挤压到第二听觉和触觉咔嗒声直到听到结束音调来激活RF能量；通过按压超声前开关200来进行切割直到组织分裂。
用于操作手术器械190以获得额外能力的修改程序：用触发器196激活RF能量并保持，同时激活前按钮开关200以激活超声换能器，这将导致电外科和超声能量模态的同时施加被同时递送到组织。
在另选的具体实施中，用于激活超声能量的前按钮开关200可经由外科装置190上或电源发生器206上的模式选择器切换成不同速度。
例如，上文结合图92至图96描述的外科器械100、150、190及相关联的算法(包括图1至图91所述的端部执行器)可例如结合以下发生器和模块化能量系统在以下外科集线器系统中实现。
图97示出了根据本公开的至少一个方面的包括金属夹钳、电极、多个夹持臂垫以及间隙垫的另选夹持臂。图97示出了根据本公开的至少一个方面的包括金属夹钳2904、电极2906、延伸穿过电极2906中的孔的多个夹持臂垫2920、间隙垫2930以及间隙垫2910的另选夹持臂2900。电极2906在焊接位置2908处附接到金属夹钳2906。电极2906包裹金属夹钳2904，并且电极2906可偏转。间隙垫2910具有顶部PI层2912和用于压力控制的直接附接到金属夹钳2904的底部弹性体层2914。夹持臂垫2920直接附接到金属夹钳2904，并且是具有由PTFE制成的用于减少热量的高压中心区2922和由PI制成的用于电极2906偏转的外部区2924的复合垫。
在一个方面，组合式超声/双极RF能量外科装置被配置为能够在外科集线器系统内操作。图98是根据本公开的至少一个方面的包括与可视化系统3108、机器人系统3110和智能器械3112配对的外科集线器3106的外科系统3102。现在参见图98，集线器3106被描绘为与可视化系统3108、机器人系统3110和以与图92至图97所述的外科器械100、150、190类似的方式构造的手持式智能外科器械3112通信。集线器3106包括集线器显示器3135、成像模块3138、发生器模块3140、通信模块3130、处理器模块3132和存储阵列3134。在某些方面，如图98中所示，集线器3106还包括排烟模块3126和/或抽吸/冲洗模块3128。
在外科规程期间，用于密封和/或切割的对组织的能量施加通常与排烟、抽吸过量流体和/或冲洗组织相关联。来自不同来源的流体管线、功率管线和/或数据管线通常在外科规程期间缠结。在外科规程期间解决该问题可丢失有价值的时间。断开管线可需要将管线与其相应的模块断开连接，这可需要重置模块。集线器模块化壳体3136提供用于管理功率管线、数据管线和流体管线的统一环境，这减小了此类管线之间缠结的频率。
本公开的各方面提供了用于外科规程中的外科集线器，该外科规程涉及将能量施加到外科部位处的组织。外科集线器包括集线器壳体和能够可滑动地接纳在集线器壳体的对接底座中的组合发生器模块。对接底座包括数据触点和功率触点。组合发生器模块包括座置在单个单元中的超声能量发生器部件、双极RF能量发生器部件和单极RF能量发生器部件中的两个或更多个。在一个方面，组合发生器模块还包括排烟部件，用于将组合发生器模块连接到外科器械的至少一根能量递送缆线、被配置为能够排出通过向组织施加治疗能量而产生的烟雾、流体和/或颗粒的至少一个排烟部件、以及从远程外科部位延伸至排烟部件的流体管线。
在一个方面，流体管线是第一流体管线，并且第二流体管线从远程外科部位延伸至可滑动地接纳在集线器壳体中的抽吸和冲洗模块。在一个方面，集线器壳体包括流体接口。
某些外科规程可需要将多于一种能量类型施加到组织。一种能量类型可更有利于切割组织，而另一种不同的能量类型可更有利于密封组织。例如，双极发生器可用于密封组织，而超声发生器可用于切割密封的组织。本公开的各方面提供了一种解决方案，其中集线器模块化壳体136被配置为能够容纳不同的发生器，并且有利于它们之间的交互式通信。集线器模块化壳体136的优点之一是使得能够快速地移除和/或更换各种模块。
本公开的方面提供了在涉及将能量施加到组织的外科规程中使用的模块化外科壳体。模块化外科壳体包括第一能量发生器模块，该第一能量发生器模块被配置为能够生成用于施加到组织的第一能量，和第一对接底座，该第一对接底座包括第一对接端口，该第一对接端口包括第一数据和功率触点，其中第一能量发生器模块可滑动地运动成与该功率和数据触点电接合，并且其中第一能量发生器模块可滑动地运动出与第一功率和数据触点的电接合，
对上文进行进一步描述，模块化外科壳体还包括第二能量发生器模块，该第二能量发生器模块被配置为能够生成不同于第一能量的第二能量以用于施加到组织，和第二对接底座，该第二对接底座包括第二对接端口，该第二对接端口包括第二数据和功率触点，其中第二能量发生器模块可滑动地运动成与功率和数据触点电接合，并且其中第二能量发生器可滑动地运动出于第二功率和数据触点的电接触。
此外，模块化外科壳体还包括在第一对接端口和第二对接端口之间的通信总线，其被配置为能够有利于第一能量发生器模块和第二能量发生器模块之间的通信。
在一个方面，本公开提供了一种被配置为能够驱动组合式超声/双极RF能量外科装置的发生器。图99示出了根据本公开的至少一个方面的发生器3900的示例。如图99所示，发生器3900是一种形式的发生器，其被配置为能够联接到如图92至图97所述的外科器械100、150、190，并且被进一步配置为能够在包括如图98所示的模块化通信集线器的外科数据网络中执行自适应超声和电外科控制算法。发生器3900被配置为能够将多个能量模态递送到外科器械。发生器3900提供用于独立地或同时将能量递送到外科器械的RF信号和超声信号。RF信号和超声信号可单独或组合提供，并且可同时提供。如上所述，至少一个发生器输出端可通过单个端口递送多种能量模态(例如，超声、双极或单极RF、不可逆和/或可逆电穿孔和/或微波能量等等)，并且这些信号可分开或同时被递送到端部执行器以处理组织。发生器3900包括耦接到波形发生器3904的处理器3902。处理器3902和波形发生器3904被配置为能够基于存储在耦接到处理器3902的存储器中的信息来生成多种信号波形，为了本公开清楚起见而未示出存储器。与波形相关联的数字信息被提供给波形发生器3904，该波形发生器包括一个或多个DAC电路以将数字输入转换成模拟输出。模拟输出被馈送到放大器3906以用于信号调节和放大。放大器3906的经调节和放大的输出耦接到功率变压器3908。信号通过功率变压器3908耦接到患者隔离侧中的次级侧。第一能量模态的第一信号被提供给被标记为ENERGY1和RETURN的端子之间的外科器械。第二能量模态的第二信号耦接到电容器3910两端并被提供给被标记为ENERGY2和RETURN的端子之间的外科器械。应当理解，可输出超过两种能量模态，并且因此下标“n”可被用来指定可提供多至n个ENERGYn端子，其中n是大于1的正整数。还应当理解，在不脱离本公开的范围的情况下，可提供多至“n”个返回路径RETURNn。
第一电压感测电路3912耦接到被标记为ENERGY1和RETURN路径的端子的两端，以测量两者间的输出电压。第二电压感测电路3924耦接到被标记为ENERGY2和RETURN路径的端子的两端，以测量两者间的输出电压。如图所示，电流感测电路3914与功率变压器3908的次级侧的RETURN支路串联设置，以测量任一能量模态的输出电流。如果为每种能量模态提供不同的返回路径，则应在每个返回支路中提供单独的电流感测电路。第一电压感测电路3912和第二电压感测电路3924的输出被提供给相应的隔离变压器3916、3922，并且电流感测电路3914的输出被提供给另一隔离变压器3918。功率变压器3908的初级侧(非患者隔离侧)上的隔离变压器3916、3928、3922的输出被提供给一个或多个ADC电路3926。ADC电路3926的数字化输出被提供给处理器3902用于进一步处理和计算。可采用输出电压和输出电流反馈信息来调节提供给外科器械的输出电压和电流，并且计算输出阻抗等参数。处理器3902和患者隔离电路之间的输入/输出通信通过接口电路3920提供。传感器也可通过接口电路3920与处理器3902电通信。
在一个方面，阻抗可由处理器3902通过将耦接在被标记为ENERGY1/RETURN的端子两端的第一电压感测电路3912或耦接在被标记为ENERGY2/RETURN的端子两端的第二电压感测电路3924的输出除以与电力变压器3908的次级侧的RETURN支路串联设置的电流感测电路3914的输出来确定。第一电压感测电路3912和第二电压感测电路3924的输出被提供给单独的隔离变压器3916、3922，并且电流感测电路3914的输出被提供给另一隔离变压器3916。来自ADC电路3926的数字化电压和电流感测测量值被提供给处理器3902以用于计算阻抗。例如，第一能量模态ENERGY1可以是超声能量，并且第二能量模态ENERGY2可以是RF能量。然而，除了超声和双极或单极RF能量模态之外，其他能量模态还包括不可逆和/或可逆电穿孔和/或微波能量等。而且，虽然图99所示的示例示出了可为两种或更多种能量模态提供单个返回路径RETURN，但在其他方面，可为每种能量模态ENERGYn提供多个返回路径RETURNn。因此，如本文所述，超声换能器阻抗可通过将第一电压感测电路3912的输出除以电流感测电路3914的输出来测量，并且组织阻抗可通过将第二电压感测电路3924的输出除以电流感测电路3914的输出来测量。
如图99中所示，包括至少一个输出端口的发生器3900可包括具有单个输出端和多个分接头的功率变压器3908，以例如根据正在被执行的组织处理类型以一种或多种能量模态(诸如超声、双极或单极RF、不可逆和/或可逆电穿孔和/或微波能量等等)的形式向端部执行器提供功率。例如，发生器3900可用更高电压和更低电流递送能量以驱动超声换能器，用更低电压和更高电流递送能量以驱动RF电极以用于密封组织，或者用凝固波形递送能量以用于使用单极或双极RF电外科电极进行点凝固。来自发生器3900的输出波形可被操纵、切换或滤波，以向外科器械的端部执行器提供频率。超声换能器与发生器3900输出端的连接将优选地位于被标记为ENERGY1和RETURN的输出端之间，如图98所示。在一个示例中，RF双极电极与发生器3900输出端的连接将优选地位于被标记为ENERGY2和RETURN的输出端之间。在单极输出的情况下，优选的连接将是ENERGY2输出端的有源电极(例如，铅笔或其他探头)以及连接至RETURN输出端的合适的返回垫。
附加细节公开于2017年3月30日公布的标题为“TECHNIQUES FOR OPERATINGGENERATOR FOR DIGITALLY GENERATING ELECTRICAL SIGNAL WAVEFORMS AND SURGICALINSTRUMENTS”的美国专利申请公布2017/0086914中，该专利申请全文以引用方式并入本文。
在一个方面，本公开提供了一种被配置为能够驱动组合式超声/双极RF能量外科装置的模块化能量系统。图100是根据本公开的至少一个方面的能够组合以定制模块化能量系统的多种模块和其他部件的图。图101A是根据本公开的至少一个方面的第一示例性模块化能量系统配置，其包括头模块和显示屏，该显示屏呈现用于中继关于连接到头模块的模块的信息的图形用户界面(GUI)。图101A是根据本公开的至少一个方面的安装到推车的图101B所示的模块化能量系统。
现在参考图99至图101B，由于执行外科规程所需的设备数量，世界上的每个地方的OR都是线绳、装置和人的缠结的网。外科资本设备往往是导致该问题的主要因素，因为大多数外科资本设备执行单个专门的任务。由于其专化的性质，并且外科医生在单次外科规程的过程期间需要使用多种不同类型的装置，因此可能会迫使OR常备两台或甚至更多台外科资本设备(诸如能量发生器)。这些外科资本设备中的每台外科资本设备必须分别插入功率源中，并且可连接到在OR人员之间经过的一个或多个其他装置，从而产生必须导航的线绳的缠结。现代OR中面临的另一个问题是，这些专门的外科资本设备中的每台外科资本设备都具有其自己的用户界面，并且必须独立于OR内的其他设备进行控制。这在正确地控制彼此连接的多个不同装置方面产生了复杂性，并且迫使用户接受训练并记住不同类型的用户界面(除了在每台资本设备之间进行更换之外，还可基于正在被执行的任务或外科规程来进行更换)。这种繁琐、复杂的过程可能需要在OR内安置更多的人员，并且如果多个装置不能正确地彼此串联控制，则可能产生危险。因此，将外科资本设备技术合并到能够灵活满足外科医生需求的单一系统中以减少OR内外科资本设备的占地面积将简化用户体验，减少OR中的混乱情况，并防止与同时控制多台资本设备相关联的困难和危险。此外，使此类系统可扩展或可定制将允许将新技术便利地结合到现有外科系统中，从而无需更换整个外科系统，也无需OR人员学习每种新技术的新用户界面或设备控制。
外科集线器可被配置为能够互换地接纳多种模块，这些模块继而可与外科装置(例如，外科器械或排烟器)进行交互或提供各种其他功能(例如，通信)。在一个方面，外科集线器可体现为结合图100至图101B示出的模块化能量系统4000。模块化能量系统4000可包括能够以堆叠配置连接在一起的多种不同模块4001。在一个方面，模块4001可在堆叠或以其他方式连接在一起形成单个组件时物理地且能够通信地耦接在一起。此外，模块4001可以不同的组合或布置可互换地连接在一起。在一个方面，模块4001中的每个模块可包括沿着其上表面和下表面设置的一致或通用的连接器阵列，从而允许任何模块4001以任何布置方式连接到另一个模块4001(不同的是，在一些方面，特定模块类型(诸如头模块4002)可被配置为能够用作例如堆叠内的最上面的模块)。在一个另选方面，模块化能量系统4000可包括被配置为能够接纳和保持模块4001的外壳，如图98所示。模块化能量系统4000还可包括还能够连接到模块4001或以其他方式与该模块相关联的多种不同的部件或附件。在另一方面，模块化能量系统4000可体现为外科集线器3106的发生器模块3140、3900(图98至图99)。在又一方面，模块化能量系统4000可以是与外科集线器3106不同的系统。在此类方面，模块化能量系统4000可通信地耦接到外科集线器3106以用于在其间传输和/或接收数据。
模块化能量系统4000可由多种不同的模块4001组装而成，其一些示例在图100中示出。不同类型的模块4001中的每个模块可提供不同的功能，从而允许模块化能量系统4000组装成不同的配置，以通过定制包括在每个模块化能量系统4000中的模块4001来定制模块化能量系统4000的功能和能力。模块化能量系统4000的模块4001可包括例如头模块4002(其可包括显示屏4006)、能量模块4004、技术模块4040和可视化模块4042。在所示的方面，头模块4002被配置为能够用作模块化能量系统叠堆内的顶部或最上面的模块，并且因此沿着其顶表面可不含连接器。在另一方面，头模块4002可被配置为能够定位在模块化能量系统叠堆内的底部或最下面的模块处，并且因此沿着其底表面可不含连接器。在又一方面，头模块4002可被配置为能够定位在模块化能量系统叠堆内的中间位置处，并且因此可包括沿着其底表面和顶表面两者的连接器。头模块4002可被配置为能够通过头模块上的物理控件4011和/或在显示屏4006上呈现的图形用户界面(GUI)4008来控制每个模块4001和与其连接的部件的系统级设定。此类设定可包括模块化能量系统4000的激活、警报的量、脚踏开关设定、设定图标、用户界面的外观或配置、登录到模块化能量系统4000的外科医生档案和/或正在被执行的外科规程的类型。头模块4002还可被配置为能够对连接到头模块4002的模块4001提供通信、处理和/或功率。能量模块4004(其也可称为发生器模块3140、3900(图98至图99))可被配置为能够产生用于驱动与该能量模块连接的电外科器械和/或超声外科器械的一种或多种能量模态，诸如上文结合图99中所示的发生器3900所述。技术模块4040可被配置为能够提供附加的或扩展的控制算法(例如，用于控制能量模块4004的能量输出的电外科控制算法或超声控制算法)。可视化模块4042可被配置为能够与可视化装置(即，观测设备)进行交互，并且因此提高可视化能力。
模块化能量系统4000还可包括多种附件4029，这些附件能够连接到模块4001以用于控制其功能，或者以其他方式被配置为能够与模块化能量系统4000协同工作。附件4029可包括例如单踏板脚踏开关4032、双踏板脚踏开关4034和用于在其上支撑模块化能量系统4000的推车4030。脚踏开关4032、4034可被配置为能够控制例如由能量模块4004输出的特定能量模态的激活或功能。
通过利用模块化部件，所描绘的模块化能量系统4000提供外科平台，该外科平台随着技术的可用性而优化并且能够根据设施和/或外科医生的需要进行定制。此外，模块化能量系统4000支持组合装置(例如，双电外科和超声能量发生器)并且支持用于定制组织效应的软件驱动算法。此外，外科系统架构通过将对于外科手术至关重要的多种技术组合到单个系统中来减少资本占地面积。
能够结合模块化能量系统4000使用的各种模块化部件可包括单极能量发生器、双极能量发生器、双电外科/超声能量发生器、显示屏以及各种其他模块和/或其他部件，它们中的一些也在上文中结合图1至图97进行了描述。
现在参见图101A，在一些方面，头模块4002可包括显示屏4006，该显示屏呈现GUI4008以用于中继关于连接到头模块4002的模块4001的信息。在一些方面，显示屏4006的GUI4008可提供构成模块化能量系统4000的特定配置的所有模块4001的合并控制点。在另选的方面，头模块4002可不含显示屏4006，或者显示屏4006可以可拆卸地连接到头模块4002的外壳4010。在此类方面，头模块4002能够可通信地耦接到外部系统，该外部系统被配置为能够显示由模块化能量系统4000的模块4001生成的信息。例如，在机器人外科应用中，模块化能量系统4000能够可通信地耦接到机器人推车或机器人控制台，该机器人推车或机器人控制台被配置为能够向机器人外科系统的操作人员显示由模块化能量系统4000生成的信息。又如，模块化能量系统4000能够可通信地耦接到移动显示器，该移动显示器可被携带或固定到外科工作人员以供其查看。在又一示例中，模块化能量系统4000能够可通信地耦接到外科集线器4100或可包括显示器4104的另一计算机系统。在利用与模块化能量系统4000分开或以其他方式与该模块化能量系统不同的用户界面的方面，用户界面可与模块化能量系统4000整体或其一个或多个模块4001无线连接，使得用户界面可在其上显示来自所连接的模块4001的信息。
仍然参见图101A，能量模块4004可包括端口组件4012，该端口组件包括多个不同的端口，这些端口被配置为能够将不同的能量模态递送到能够连接到其的对应的外科器械。在图100至图101B所示的具体方面，端口组件4012包括双极端口4014、第一单极端口4016a、第二单极端口4018b、中性电极端口4018(单极返回垫能够连接到该中性电极端口)和组合能量端口4020。然而，端口的这种特定组合仅仅是为了进行示意性的说明，并且端口和/或能量模态的另选组合对于端口组件4012是可能的。
如上所述，模块化能量系统4000可组装成不同的配置。此外，模块化能量系统4000的不同配置也可用于不同的外科规程类型和/或不同的任务。例如，图101A至图101B示出了模块化能量系统4000的第一示例性配置，其包括连接在一起的头模块4002(包括显示屏4006)和能量模块4004。此类配置可适用于例如腹腔镜式和开放式外科规程。
图49至图53示出了包括本文所述的端部执行器、外科器械和发生器中的任一者的具有超声特征和电外科特征的示例性外科系统10。图49示出了包括发生器12和外科器械14的外科系统10。外科器械14经由电力缆线16与发生器12操作地联接。发生器12能够操作以向外科器械14提供功率以递送用于切割组织的超声能量和用于密封组织的电外科双极RF能量(即，治疗水平的RF能量)。在一个方面，发生器12被配置为能够向外科器械14提供功率以同时或独立地递送超声能量和电外科双极RF能量。
本示例的外科器械14包括柄部组件18、从柄部组件18朝远侧延伸的轴组件20以及布置在轴组件20的远侧端部处的端部执行器22。柄部组件18包括主体24，该主体包括手枪式握持部26和被配置为能够由外科医生操纵的能量控制按钮28、30。触发器32联接到主体24的下部部分并且能够朝向和远离手枪式握持部26枢转以选择性地致动端部执行器22，如下文更详细地描述。在外科器械14的其他合适变型中，柄部组件18可包括例如剪刀式握持部构型。超声换能器34容纳在主体24内部并由主体支撑。在其他构型中，超声换能器34可设置在主体24的外部。
如图50和图51所示，端部执行器22包括超声刀36和夹持臂38，该夹持臂被配置为能够朝向和远离超声刀36选择性地枢转，以用于夹持其间的组织。超声刀36与超声换能器34声学地联接，该超声换能器被配置为能够以超声频率驱动(即振动)超声刀36，用于切割和/或密封被定位成与超声刀36接触的组织。夹持臂38与触发器32操作地联接，使得夹持臂38被配置为能够响应于触发器32朝向手枪式握持部26的枢转而朝向超声刀36枢转到闭合位置。另外，夹持臂38被配置为能够响应于触发器32远离手枪式握持部26的枢转而远离超声刀36枢转到打开位置(参见例如图49至图51)。鉴于本文所提供的教导内容，可将夹持臂38与触发器32联接的各种合适的方式对于本领域的普通技术人员将是显而易见的。在一些型式中，可结合一个或多个弹性构件以朝向打开位置偏置夹持臂38和/或触发器32。
夹持垫40固定到夹持臂38的面向超声刀36的夹持侧并沿该夹持侧朝远侧延伸。夹持垫40被配置为能够在夹持臂38被致动至其闭合位置时抵靠超声刀36的对应组织处理部分接合并夹持组织。夹持臂38的至少夹持侧提供第一电极42，该电极在本文中被称为夹持臂电极42。另外，超声刀36的至少夹持侧提供第二电极44，该电极在本文中被称为刀电极44。电极42、44被配置为能够将由发生器12提供的电外科双极RF能量施加到与电极42、44电联接的组织。夹持臂电极42可用作有源电极，而刀电极44用作返回电极，或反之亦然。外科器械14可被配置为能够在使超声刀36以超声频率振动的同时，在使超声刀36以超声频率振动之前，和/或在使超声刀36以超声频率振动之后，通过电极42、44施加电外科双极RF能量。
如图49至图53所示，轴组件20沿纵向轴线延伸并且包括外管46、接纳在外管46内的内管48、以及支撑在内管48内的超声波导50。如图50至图53最佳所见，夹持臂38联接到内管48和外管46的远侧端部。具体地，夹持臂38包括一对朝近侧延伸的连接叉臂52，该一对朝近侧延伸的连接叉臂在其间接纳并可枢转地联接到内管48的远侧端部54，其中枢轴销56穿过形成于连接叉臂52和内管48的远侧端部54中的孔而被接纳。第一连接叉指状部和第二连接叉指状部58从连接叉臂52向下延伸并且可枢转地联接到外管46的远侧端部60。具体地，每个连接叉指状部58包括突起部62，该突起部可旋转地接纳在形成于外管46的远侧端部60的侧壁中的对应开口64内。
在本示例中，内管48相对于柄部组件18纵向地固定，并且外管46被配置为能够沿轴组件20的纵向轴线相对于内管48和柄部组件18平移。随着外管46朝远侧平移，夹持臂38围绕枢轴销56朝向其打开位置枢转。随着外管46朝近侧平移，夹持臂38朝向其闭合位置以相反方向枢转。外管46的近侧端部例如经由连杆组件与触发器32操作地联接，使得触发器32的致动导致外管46相对于内管48平移，从而使夹持臂38打开或闭合。在本文未示出的其他合适构型中，外管46可为纵向固定的，并且内管48可被配置为能够平移以用于使夹持臂38在其打开位置和闭合位置之间移动。
轴组件20和端部执行器22被配置为能够相对于柄部组件18围绕纵向轴线一起旋转。图52所示的保持销66横向延伸穿过外管46、内管48和波导50的近侧部分，从而使这些部件相对于彼此旋转地联接。在本示例中，在轴组件20的近侧端部部分处提供旋钮68，以有利于轴组件20和端部执行器22相对于柄部组件18的旋转。旋钮68利用保持销66旋转地固定到轴组件20，该保持销延伸穿过旋钮68的近侧套环。应当理解，在其他合适的构型中，旋钮68可被省略或被另选的旋转致动结构代替。
超声波导50例如通过螺纹连接而在其近侧端部处与超声换能器34声学地联接，并且在其远侧端部处与超声刀36声学地联接，如图53所示。超声刀36被示出为与波导50一体形成，使得刀36直接从波导50的远侧端部朝远侧延伸。这样，波导50将超声换能器34与超声刀36声学地联接，并且用于将超声机械振动从换能器34传送至刀36。因此，超声换能器34、波导50和超声刀36一起限定声学组件。在使用期间，在具有或不具有由夹持臂38提供的辅助夹持力的情况下，超声刀36均可被定位成与组织直接接触，以向组织赋予超声振动能量并由此切割和/或密封组织。例如，刀36可切穿夹持臂38与刀36的第一处理侧之间夹持的组织，或者刀36可切穿例如在“后切”移动期间被定位成与刀36的相对设置的第二处理侧接触的组织。在一些变型中，波导50可放大递送到刀36的超声振动。另外，波导50可包括能够操作以控制振动增益的各种特征部，和/或适于将波导50调谐至所选谐振频率的特征部。下文更详细地描述了超声刀36和波导50的附加特征部。
波导50由沿波导50的长度定位的多个节点支撑元件70支撑在内管48内，如图52至图53所示。具体地，节点支撑元件70在对应于由通过波导50传送的谐振超声振动限定的声学节点的位置处沿波导50纵向定位。节点支撑元件70可向波导50提供结构支撑，并且在波导50与轴组件20的内管48和外管46之间提供声学隔离。在变型中，节点支撑元件70可包括O形环。波导50在其最远侧声学节点处由图53所示的包覆模制构件72形式的节点支撑元件支撑。波导50由保持销66纵向且旋转地固定在轴组件20内，该保持销穿过形成在波导50的朝近侧布置的声学节点诸如例如最近侧声学节点处的横向通孔74。
在本示例中，超声刀36的远侧末端76位于对应于与通过波导50传送的谐振超声振动相关联的波腹的位置。当超声刀36未加载有组织时，此类构型使器械14的声学组件能够被调谐至优选的谐振频率fo。当超声换能器34由发生器12供能以将机械振动通过波导50传递至刀36时，致使刀36的远侧末端76例如在大约20微米至120微米峰值至峰值的范围内纵向振荡，并且在一些情况下，例如以大约50kHz的预定振动频率fo在大约20微米至50微米的范围内纵向振荡。当超声刀36被定位成与组织接触时，刀36的超声振荡可同时切断组织并且使相邻组织细胞中的蛋白质变性，从而提供具有最少热扩散的凝固效果。
实施例
下面提供本公开的端部执行器和外科器械的各个方面的实施例。端部执行器或外科器械的一个方面可包括下述实施例中的任一个或多个以及它们的任何组合：
实施例1.一种端部执行器，包括：夹持臂；以及超声刀，该超声刀被配置为能够联接到超声换能器以及联接到发电机的一个极；其中夹持臂包括：夹钳；悬臂式电极，该悬臂式电极被配置为能够联接到发电机的相反极，其中悬臂式电极在近侧端部处固定到夹钳并且在远侧端部处自由偏转；以及I形梁形夹持臂垫，其中夹持臂垫限定由中间部分分开的顶部横向部分和底部横向部分以限定为“I”的形状，其中悬臂式电极设置在I形梁形夹持臂垫的顶部横向部分与底部横向部分之间。
实施例2.根据实施例1所述的端部执行器，还包括设置在悬臂式电极的近侧端部处的硬耐磨间隙设定垫以在悬臂式电极与超声刀之间设定间隙。
实施例3.根据实施例1至2中任一项所述的端部执行器，其中悬臂式电极在近侧端部处限定槽开口以可滑动地接纳I形梁形夹持臂垫的中间部分。
实施例4.根据实施例1至3中任一项所述的端部执行器，其中夹钳限定纵向槽以可滑动地接纳穿过其的I形梁形夹持臂垫的底部横向部分以及中间部分的一部分。
实施例5.一种端部执行器，包括：夹持臂；以及超声刀，该超声刀被配置为能够联接到超声换能器以及联接到发电机的一个极；其中夹持臂包括：夹钳；悬臂式电极，该悬臂式电极被配置为能够联接到发电机的相反极，其中悬臂式电极在近侧端部处固定到夹钳并且在远侧端部处自由偏转；以及夹持臂垫；其中夹钳、悬臂式电极和夹持臂垫沿与超声刀重合的纵向长度限定凹陷部。
实施例6.根据实施例5所述的端部执行器，其中悬臂式电极与处于完全夹持状态的超声刀基本上齐平但不与超声刀发生金属接触，其中夹持臂垫包括重聚合物支撑垫。
实施例7.根据实施例6所述的端部执行器，还包括限定在所限定凹陷部内的孔口，以将重聚合物支撑垫热熔或固定到悬臂式电极凹陷部。
实施例8.一种端部执行器，包括：夹持臂；以及超声刀，该超声刀被配置为能够联接到超声换能器以及联接到发电机的一个极；其中夹持臂包括：夹钳，该夹钳具有近侧端部和远侧端部，该近侧端部能够围绕枢转点枢转地移动；悬臂式电极，该悬臂式电极被配置为能够联接到发电机的相反极，其中悬臂式电极包括固定到夹钳的近侧端部的近侧端部和自由偏转的远侧端部，并且悬臂式电极限定被配置为能够接触组织并将电能施加到与其接触的组织的表面；以及夹持臂垫，该夹持臂垫固定到夹钳并且具有设置在夹钳与悬臂式电极之间的至少一部分和延伸超出悬臂式电极的表面以接触组织的另一部分。
实施例9.根据实施例8所述的端部执行器，还包括至少一个间隙垫，该至少一个间隙垫固定到悬臂式电极以在超声刀与悬臂式电极之间设定间隙。
实施例10.根据实施例9所述的端部执行器，其中间隙垫位于悬臂式电极的近侧端部处。
实施例11.根据实施例9至10中任一项所述的端部执行器，其中间隙垫由硬度大于夹持臂垫的硬度的材料制成，使得间隙垫具有比夹持臂垫更长的磨损寿命，其中间隙垫材料是非柔性的并且夹持臂垫材料是柔性的，并且其中夹持臂垫由柔性材料制成。
实施例12.根据实施例9至11中任一项所述的端部执行器，其中悬臂式电极限定位于悬臂式电极的近侧端部处的间隙垫、位于悬臂式电极的远侧端部处的间隙垫以及位于近侧端部与远侧端部之间的间隙垫。
实施例13.根据实施例8至12中任一项所述的端部执行器，其中夹持臂垫包括固定地附接到夹钳的基部部分和在朝向悬臂式电极的方向上从该基部延伸的多个齿。
实施例14.根据实施例8至13中任一项所述的端部执行器，还包括：至少一个间隙垫，所述至少一个间隙垫固定悬臂式电极以在超声刀与悬臂式电极之间设定间隙；其中夹持臂垫包括固定地附接到夹钳的基部部分和在朝向悬臂式电极的方向上从该基部延伸的多个齿；并且其中悬臂式电极限定多个孔口，这些孔口的尺寸和构造被设置成接纳穿过其的至少一个间隙垫和多个齿；其中悬臂式电极在近侧限定至少一个孔口，从而限定开口端以可滑动地接纳间隙垫中的一个间隙垫；以及位于悬臂式电极的远侧端部处的间隙垫和位于悬臂式电极的远侧端部与近侧端部之间的间隙垫，其中近侧间隙垫的尺寸大于远侧间隙垫和内侧间隙垫。
实施例15.一种端部执行器，包括：夹持臂；以及超声刀，该超声刀被配置为能够联接到超声换能器以及联接到发电机的一个极；其中夹持臂包括：夹钳；悬臂式电极，该悬臂式电极被配置为能够联接到发电机的相反极，其中悬臂式电极在近侧端部处固定到夹钳并且在远侧端部处自由偏转；静止间隙设定垫，该静止间隙设定垫位于夹持臂的远侧端部处；以及可移动浮动间隙设定垫，从而形成复合布置以产生超声刀压力，同时还在悬臂式电极与超声刀之间设定最小间隙。
实施例16.根据实施例15所述的端部执行器，其中夹持臂还包括附接到夹钳的夹持臂垫。
实施例17.根据实施例15至16中任一项所述的端部执行器，其中静止间隙设定垫附接到夹钳。
实施例18.根据实施例15至17中任一项所述的端部执行器，其中静止间隙设定垫被配置为能够施加末端压力以及辅助组织抓握并防止悬臂式电极与超声刀短路。
实施例19.根据实施例15至18中任一项所述的端部执行器，还包括静止夹持臂垫，其中可移动浮动间隙设定垫形成复合布置以向超声刀施加压力并且在悬臂式电极与超声刀之间设定最小间隙。
尽管已举例说明和描述了多个形式，但是申请人的意图并非将所附权利要求的范围约束或限制在此类细节中。在不脱离本公开的范围的情况下，可实现对这些形式的许多修改、变型、改变、替换、组合和等同物，并且本领域技术人员将想到这些形式的许多修改、变型、改变、替换、组合和等同物。此外，另选地，可将与所描述的形式相关联的每个元件的结构描述为用于提供由所述元件执行的功能的器件。另外，在公开了用于某些部件的材料的情况下，也可使用其他材料。因此，应当理解，上述具体实施方式和所附权利要求旨在涵盖属于本发明所公开的形式范围内的所有此类修改、组合和变型。所附权利要求旨在涵盖所有此类修改、变型、改变、替换、修改和等同物。
上述具体实施方式已经由使用框图、流程图和/或示例阐述了装置和/或方法的各种形式。只要此类框图、流程图和/或示例包含一个或多个功能和/或操作，本领域的技术人员就要将其理解为此类框图、流程图和/或示例中的每个功能和/或操作都可以单独和/或共同地通过多种硬件、软件、固件或实际上它们的任何组合来实施。本领域的技术人员将会认识到，本文公开的形式中的一些方面可作为在一台或多台计算机上运行的一个或多个计算机程序(例如，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(例如，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，并且根据本公开，设计电路系统和/或编写软件和/或硬件的代码将在本领域技术人员的技术范围内。另外，本领域的技术人员将会认识到，本文所述主题的机制能够作为多种形式的一个或多个程序产品进行分布，并且本文所述主题的例示性形式适用，而不管用于实际进行分布的信号承载介质的具体类型是什么。
用于编程逻辑以执行各种所公开的方面的指令可存储在系统中的存储器内，诸如动态随机存取存储器(DRAM)、高速缓存、闪存存储器或其他存储器。此外，指令可经由网络或通过其他计算机可读介质来分发。因此，机器可读介质可包括用于存储或传输以机器(例如，计算机)可读形式的信息的任何机构，但不限于软盘、光学盘、光盘只读存储器(CD-ROM)、和磁光盘、只读存储器(ROM)、随机存取存储器(RAM)、可擦除可编程只读存储器(EPROM)、电可擦除可编程只读存储器(EEPROM)、磁卡或光卡、闪存存储器、或经由电信号、光学信号、声学信号或其他形式的传播信号(例如，载波、红外信号、数字信号等)在因特网上传输信息时使用的有形的、机器可读存储装置。因此，非暂态计算机可读介质包括适于以机器(例如，计算机)可读的形式存储或传输电子指令或信息的任何类型的有形机器可读介质。
如本文任一方面所用，术语“控制电路”可指例如硬连线电路系统、可编程电路系统(例如，计算机处理器，该计算机处理器包括一个或多个单独指令处理内核、处理单元，处理器、微控制器、微控制器单元、控制器、数字信号处理器(DSP)、可编程逻辑装置(PLD)、可编程逻辑阵列(PLA)、场可编程门阵列(FPGA))、状态机电路系统、存储由可编程电路系统执行的指令的固件、以及它们的任何组合。控制电路可以集体地或单独地实现为形成更大系统的一部分的电路系统，例如集成电路(IC)、专用集成电路(ASIC)、片上系统(SoC)、台式计算机、膝上型计算机、平板计算机、服务器、智能电话等。因此，如本文所用，“控制电路”包括但不限于具有至少一个离散电路的电子电路、具有至少一个集成电路的电子电路、具有至少一个专用集成电路的电子电路、形成由计算机程序配置的通用计算设备的电子电路(如，至少部分地实施本文所述的方法和/或设备的由计算机
程序配置的通用计算机，或至少部分地实施本文所述的方法和/或设备的由计算机程序配置的微处理器)、形成存储器设备(如，形成随机存取存储器)的电子电路，和/或形成通信设备(如，调节解调器、通信开关或光电设备)的电子电路。本领域的技术人员将会认识到，可以模拟或数字方式或它们的一些组合实施本文所述的主题。
如本文的任何方面所用，术语“逻辑”可指被配置为能够执行前述操作中的任一者的应用程序、软件、固件和/或电路系统。软件可体现为记录在非暂态计算机可读存储介质上的软件包、代码、指令、指令集和/或数据。固件可体现为在存储器装置中硬编码(例如，非易失性)的代码、指令或指令集和/或数据。
如本文任一方面所用，术语“部件”、“系统”、“模块”等可指计算机相关实体、硬件、硬件和软件的组合、软件或执行中的软件。
如本文任一方面中所用，“算法”是指导致所期望结果的有条理的步骤序列，其中“步骤”是指物理量和/或逻辑状态的操纵，物理量和/或逻辑状态可(但不一定)采用能被存储、转移、组合、比较和以其他方式操纵的电或磁信号的形式。常用于指这些信号，如位、值、元素、符号、字符、术语、数字等。这些和类似的术语可与适当的物理量相关联并且仅仅是应用于这些量和/或状态的方便的标签。
网络可包括分组交换网络。通信装置可能够使用所选择的分组交换网络通信协议来彼此通信。一个示例性通信协议可包括可能够允许使用传输控制协议/因特网协议(TCP/IP)进行通信的以太网通信协议。以太网协议可符合或兼容电气和电子工程师学会(IEEE)于2008年12月发布的标题为“IEEE802.3Standard”的以太网标准和/或本标准的更高版本。另选地或附加地，通信装置可能够使用X.25通信协议彼此通信。X.25通信协议可符合或兼容由国际电信联盟电信标准化部门(ITU-T)发布的标准。另选地或附加地，通信装置可能够使用帧中继通信协议彼此通信。帧中继通信协议可符合或兼容由国际电报电话咨询委员会(CCITT)和/或美国国家标准学会(ANSI)发布的标准。另选地或附加地，收发器可能够使用异步传输模式(ATM)通信协议彼此通信。ATM通信协议可符合或兼容ATM论坛于2001年8月发布的名为“ATM-MPLS Network Interworking 2.0”的ATM标准和/或该标准的更高版本。当然，本文同样设想了不同的和/或之后开发的连接取向的网络通信协议。
除非上述公开中另外明确指明，否则可以理解的是，在上述公开中，使用术语如“处理”、“估算”、“计算”、“确定”、“显示”的讨论是指计算机系统或类似的电子计算装置的动作和进程，其操纵表示为计算机系统的寄存器和存储器内的物理(电子)量的数据并将其转换成相似地表示为计算机系统存储器或寄存器或其他此类信息存储、传输或显示装置内的物理量的其他数据。
一个或多个部件在本文中可被称为“被配置为能够”、“可配置为能够”、“可操作/可操作地”、“适于/可适于”、“能够”、“可适形/适形于”等。本领域的技术人员将会认识到，除非上下文另有所指，否则“被配置为能够”通常可涵盖活动状态的部件和/或未活动状态的部件和/或待机状态的部件。
术语“近侧”和“远侧”在本文中是相对于操纵外科器械的柄部部分的临床医生来使用的。术语“近侧”是指最靠近临床医生的部分，术语“远侧”是指远离临床医生定位的部分。还应当理解，为简洁和清楚起见，本文可结合附图使用诸如“竖直”、“水平”、“上”和“下”等空间术语。然而，外科器械在许多取向和方位中使用，并且这些术语并非是限制性的和/或绝对的。
本领域的技术人员将认识到，一般而言，本文、以及特别是所附权利要求(例如，所附权利要求的正文)中所使用的术语通常旨在为“开放”术语(例如，术语“包括”应解释为“包括但不限于”，术语“具有”应解释为“至少具有”，术语“包含”应解释为“包含但不限于”等)。本领域的技术人员还应当理解，如果所引入权利要求表述的具体数目为预期的，则此类意图将在权利要求中明确表述，并且在不存在此类叙述的情况下，不存在此类意图。例如，为有助于理解，下述所附权利要求可含有对介绍性短语“至少一个”和“一个或多个”的使用以引入权利要求。然而，对此类短语的使用不应视为暗示通过不定冠词“一个”或“一种”引入权利要求表述将含有此类引入权利要求表述的任何特定权利要求限制在含有仅一个这样的表述的权利要求中，甚至当同一权利要求包括介绍性短语“一个或多个”或“至少一个”和诸如“一个”或“一种”(例如，“一个”和/或“一种”通常应解释为意指“至少一个”或“一个或多个”)的不定冠词时；这也适用于对用于引入权利要求表述的定冠词的使用。
另外，即使明确叙述引入权利要求叙述的特定数目，本领域的技术人员应当认识到，此种叙述通常应解释为意指至少所叙述的数目(例如，在没有其他修饰语的情况下，对“两个叙述”的裸叙述通常意指至少两个叙述、或两个或更多个叙述)。此外，在其中使用类似于“A、B和C中的至少一者等”的惯例的那些情况下，一般而言，此类构造意在具有本领域的技术人员将理解所述惯例的意义(例如，“具有A、B和C中的至少一者的系统”将包括但不限于具有仅A、仅B、仅C、A和B一起、A和C一起、B和C一起和/或A、B和C一起等的系统)。在其中使用类似于“A、B或C中的至少一者等”的惯例的那些情况下，一般而言，此类构造意在具有本领域的技术人员将理解所述惯例的意义(例如，“具有A、B或C中的至少一者的系统”应当包括但不限于具有仅A、仅B、仅C、A和B一起、A和C一起、B和C一起和/或A、B和C一起等的系统)。本领域的技术人员还应当理解，通常，除非上下文另有指示，否则无论在具体实施方式、权利要求或附图中呈现两个或更多个替代术语的转折性词语和/或短语应理解为涵盖包括所述术语中的一者、所述术语中的任一个或这两个术语的可能性。例如，短语“A或B”通常将被理解为包括“A”或“B”或“A和B”的可能性。
对于所附的权利要求，本领域的技术人员将会理解，其中表述的操作通常可以任何顺序进行。另外，尽管以一个或多个序列出了各种操作流程图，但应当理解，可以不同于所示顺序的其他顺序执行各种操作，或者可同时执行所述各种操作。除非上下文另有规定，否则此类替代排序的示例可包括重叠、交错、中断、重新排序、增量、预备、补充、同时、反向，或其他改变的排序。此外，除非上下文另有规定，否则像“响应于”、“相关”这样的术语或其他过去式的形容词通常不旨在排除此类变体。
值得一提的是，任何对“一个方面”、“一方面”、“一范例”、“一个范例”的提及均意指结合所述方面所述的具体特征部、结构或特征包括在至少一个方面中。因此，在整个说明书的各种位置出现的短语“在一个方面”、“在一方面”、“在一范例中”、“在一个范例中”不一定都指同一方面。此外，具体特征部、结构或特征可在一个或多个方面中以任何合适的方式组合。
本说明书提及和/或在任何申请数据表中列出的任何专利申请，专利，非专利公布或其他公开材料均以引用方式并入本文，只要所并入的材料在此不一致。因此，并且在必要的程度下，本文明确列出的公开内容代替以引用方式并入本文的任何冲突材料。据称以引用方式并入本文但与本文列出的现有定义、陈述或其他公开材料相冲突的任何材料或其部分，将仅在所并入的材料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各种形式和各种修改。与此一同提交的权利要求书旨在限定完整范围。

Claims (19)

1.一种端部执行器，包括：
夹持臂；以及
超声刀，所述超声刀被配置为能够声学联接到超声换能器并且电联接到发电机的一个极；
其中，所述夹持臂包括：
夹钳；
悬臂式电极，所述悬臂式电极被配置为能够电联接到所述发电机的相反极，其中，所述悬臂式电极在近侧端部处固定到所述夹钳并且在远侧端部处自由偏转；以及
I形梁形夹持臂垫，其中，所述夹持臂垫限定由中间部分分开的顶部横向部分和底部横向部分以限定为“I”的形状，其中，所述悬臂式电极设置在所述I形梁形夹持臂垫的所述顶部横向部分与所述底部横向部分之间。
2.根据权利要求1所述的端部执行器，还包括设置在所述悬臂式电极的所述近侧端部处的硬耐磨间隙设定垫以在所述悬臂式电极与所述超声刀之间设定间隙。
3.根据权利要求1所述的端部执行器，其中，所述悬臂式电极在近侧端部处限定槽开口以可滑动地接纳所述I形梁形夹持臂垫的所述中间部分。
4.根据权利要求1所述的端部执行器，其中，所述夹钳限定纵向槽以可滑动地接纳穿过所述纵向槽的所述I形梁形夹持臂垫的所述底部横向部分以及所述中间部分的一部分。
5.一种端部执行器，包括：
夹持臂；以及
超声刀，所述超声刀被配置为能够声学联接到超声换能器并且电联接到发电机的一个极；
其中，所述夹持臂包括：
夹钳；
悬臂式电极，所述悬臂式电极被配置为能够电联接到所述发电机的相反极，其中，所述悬臂式电极在近侧端部处固定到所述夹钳并且在远侧端部处自由偏转；以及
夹持臂垫；
其中，所述夹钳、所述悬臂式电极和所述夹持臂垫沿与所述超声刀重合的纵向长度限定凹陷部。
6.根据权利要求5所述的端部执行器，其中，所述悬臂式电极与处于完全夹持状态的所述超声刀基本上齐平但不与所述超声刀发生金属接触，其中，所述夹持臂垫包括重聚合物支撑垫。
7.根据权利要求6所述的端部执行器，还包括限定在所限定凹陷部内的孔口，以将所述重聚合物支撑垫热熔或固定到所述悬臂式电极凹陷部。
8.一种端部执行器，包括：
夹持臂；以及
超声刀，所述超声刀被配置为能够声学联接到超声换能器并且电联接到发电机的一个极；
其中，所述夹持臂包括：
夹钳，所述夹钳具有近侧端部和远侧端部，所述近侧端部能够围绕枢转点枢转地移动；
悬臂式电极，所述悬臂式电极被配置为能够联接到所述发电机的相反极，其中，所述悬臂式电极包括固定到所述夹钳的所述近侧端部的近侧端部和自由偏转的远侧端部，并且所述悬臂式电极限定被配置为能够接触组织并将电能施加到与其接触的组织的表面；以及
夹持臂垫，所述夹持臂垫固定到所述夹钳并且具有设置在所述夹钳与所述悬臂式电极之间的至少一部分和延伸超出所述悬臂式电极的所述表面以接触组织的另一部分。
9.根据权利要求8所述的端部执行器，还包括至少一个间隙垫，所述至少一个间隙垫固定到所述悬臂式电极以在所述超声刀与所述悬臂式电极之间设定间隙。
10.根据权利要求9所述的端部执行器，其中，所述间隙垫位于所述悬臂式电极的近侧端部处。
11.根据权利要求9所述的端部执行器，其中，所述间隙垫由硬度大于所述夹持臂垫的硬度的材料制成，使得所述间隙垫具有比所述夹持臂垫更长的磨损寿命，其中，所述间隙垫材料是非柔性的并且所述夹持臂垫材料是柔性的，并且其中，所述夹持臂垫由柔性材料制成。
12.根据权利要求9所述的端部执行器，其中，所述悬臂式电极限定位于所述悬臂式电极的近侧端部处的间隙垫、位于所述悬臂式电极的远侧端部处的间隙垫以及位于所述近侧端部与所述远侧端部之间的间隙垫。
13.根据权利要求8所述的端部执行器，其中，所述夹持臂垫包括固定地附接到所述夹钳的基部部分和在朝向所述悬臂式电极的方向上从所述基部延伸的多个齿。
14.根据权利要求8所述的端部执行器，还包括：
至少一个间隙垫，所述至少一个间隙垫固定所述悬臂式电极以在所述超声刀与所述悬臂式电极之间设定间隙；
其中，所述夹持臂垫包括固定地附接到所述夹钳的基部部分和在朝向所述悬臂式电极的方向上从所述基部延伸的多个齿；并且
其中，所述悬臂式电极限定多个孔口，所述多个孔口的尺寸和构造被设置成接纳穿过所述孔口的所述至少一个间隙垫和所述多个齿；
其中，所述悬臂式电极在所述近侧限定至少一个孔口，从而限定开口端以可滑动地接纳所述间隙垫中的一个间隙垫；以及
位于所述悬臂式电极的所述远侧端部处的间隙垫和位于所述悬臂式电极的所述远侧端部与所述近侧端部之间的间隙垫，其中，所述近侧间隙垫的尺寸大于所述远侧间隙垫和内侧间隙垫。
15.一种端部执行器，包括：
夹持臂；以及
超声刀，所述超声刀被配置为能够声学联接到超声换能器并且电联接到发电机的一个极；
其中，所述夹持臂包括：
夹钳；
悬臂式电极，所述悬臂式电极被配置为能够电联接到所述发电机的相反极，其中，所述悬臂式电极在近侧端部处固定到所述夹钳并且在远侧端部处自由偏转；
静止间隙设定垫，所述静止间隙设定垫位于所述夹持臂的远侧端部处；以及
可移动浮动间隙设定垫，从而形成复合布置以产生超声刀压力，同时还在所述悬臂式电极与所述超声刀之间设定最小间隙。
16.根据权利要求15所述的端部执行器，其中，所述夹持臂还包括附接到所述夹钳的夹持臂垫。
17.根据权利要求15所述的端部执行器，其中，所述静止间隙设定垫附接到所述夹钳。
18.根据权利要求15所述的端部执行器，其中，所述静止间隙设定垫被配置为能够施加末端压力以及辅助组织抓握并防止所述悬臂式电极与所述超声刀短路。
19.根据权利要求15所述的端部执行器，还包括静止夹持臂垫，其中，所述可移动浮动间隙设定垫形成复合布置以向所述超声刀施加压力并且在所述悬臂式电极与所述超声刀之间设定最小间隙。
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