CN101883531B - 人体工程学外科手术器械 - Google Patents
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
- A61B17/320092—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/0042—Surgical instruments, devices or methods, e.g. tourniquets with special provisions for gripping
- A61B2017/00424—Surgical instruments, devices or methods, e.g. tourniquets with special provisions for gripping ergonomic, e.g. fitting in fist
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/0042—Surgical instruments, devices or methods, e.g. tourniquets with special provisions for gripping
- A61B2017/00429—Surgical instruments, devices or methods, e.g. tourniquets with special provisions for gripping with a roughened portion
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- A—HUMAN NECESSITIES
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- A—HUMAN NECESSITIES
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/28—Surgical forceps
- A61B17/29—Forceps for use in minimally invasive surgery
- A61B2017/2926—Details of heads or jaws
- A61B2017/2927—Details of heads or jaws the angular position of the head being adjustable with respect to the shaft
- A61B2017/2929—Details of heads or jaws the angular position of the head being adjustable with respect to the shaft with a head rotatable about the longitudinal axis of the shaft
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
- A61B17/320092—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw
- A61B2017/320093—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw additional movable means performing cutting operation
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
- A61B17/320092—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw
- A61B2017/320094—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw additional movable means performing clamping operation
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
- A61B17/320092—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw
- A61B2017/320095—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw with sealing or cauterizing means
Abstract
本发明公开了外科手术器械柄部组件,所述外科手术器械柄部组件包括外壳,所述外壳具有近端和远端。近侧开口在所述外壳的近端形成。远侧开口在所述外壳的远端形成。所述近侧开口和所述远侧开口限定纵向轴线。所述柄部从所述纵向轴线向下地延伸。所述柄部限定近侧接触表面、鞍形表面和稳定性尾部。触发器可枢转地附接到所述外壳并且能够相对于所述柄部可枢转地活动。
Description
背景技术
包括空芯器械和实芯器械两者的超声外科手术器械被用来安全有效地治疗许多病症。超声外科手术器械、尤其是实芯超声外科手术器械是有利的,因为它们可以用于以在超声频率下传输到外科手术端部执行器的机械振动形式的能量切割和/或凝固组织。当以合适的能量级传输至组织并且使用合适的端部执行器时,超声振动可以用于切割、解剖、凝固、升高或分离组织。利用实芯技术的超声外科手术器械尤其有利,因为超声能量可以从超声换能器通过超声传输波导传输到外科手术端部执行器。此类器械可以用于开放式手术或微创手术,例如内窥镜手术或腹腔镜手术,其中端部执行器穿过套针到达外科手术部位。
以超声频率启动或激发此类器械的端部执行器(例如切割刀片、球形凝固器)可以引发纵向振动,该纵向振动在相邻组织内产生局部热量,从而为切割和凝固两者提供便利。由于超声外科手术器械的性质,可以将具体的超声激活的端部执行器设计为可执行许多功能,包括(例如)切割和凝固。
例如,通过电激励换能器在外科手术端部执行器中引发超声振动。换能器可由器械手柄中的一个或多个压电元件或磁致伸缩元件构成。由换能器部分产生的振动通过超声波导传输至外科手术端部执行器,该超声波导从换能器部分延伸至外科手术端部执行器。将波导和端部执行器设计成以与换能器相同的频率共振。
当端部执行器附接到换能器上时,系统整体的频率可能与换能器本身的频率相同。换能器和端部执行器可设计成在两个不同的频率共振,当接合或连接到一起时,可以第三个频率共振。端部执行器在顶端处的纵向超声振动的零至峰振幅d表现为共振频率的简单正弦曲线,用以下公式表示:
d=A sin(ωt)
其中:ω=角频率,其等于循环频率f的2π倍;并且
A=零至峰的幅值。
将纵向偏移定义为峰到峰(p-t-p)幅值,其恰好为正弦波幅值的两倍或为2A。
实芯超声手术器械可分为两类:单个元件端部执行器和多重元件端部执行器。单个元件端部执行器器械包括多种刀片类型,例如球形、钩形、曲线形和凝固剪。当组织柔软并且被松散地支承时,单个元件端部执行器器械使刀片向组织施加压力的能力是有限的。要有效地将超声能量作用到组织上,必须提供较大压力。单个元件端部执行器无法抓住组织导致施加超声能量时更加无法完全接合组织表面,从而导致止血和组织连接低于所需的效果。多重元件端部执行器包括具有夹臂的夹持机构,该夹臂结合振荡刀片工作以形成钳状结构。例如,超声夹紧凝固器提供了改进的超声外科手术器械以切割/凝固组织,尤其是松散并且无支承的组织。夹持机构将组织压在振动的超声刀片上,并向组织施加压缩力或偏置力,从而在刀片运动衰减更小的情况下实现较快的组织切割和止血(如凝固)。
作为开放式外科手术的替代方式,目前很多外科医生使用内窥镜和内窥镜器械通过更小的孔状切口来远程触及器官。其直接结果是,患者趋于受益于更小的疤痕和更短的康复时间。内窥镜器械穿过与套针一起制成的套管或端口插入患者体内。套管的典型大小在3毫米至12毫米的范围内。通常优选较小的套管。然而,较小的套管继而会给设计适合穿过较小套管的内窥镜器械带来更多挑战。许多内窥镜外科手术要求切割或结扎血管或血管组织以及握持、切割、解剖、凝固、升高、操纵和/或分离组织。
出于本文的目的,“凝固”被定义为使组织细胞破裂并变干的组织干燥过程。“血管密封”或“组织密封”被定义为液化组织中的胶原以使得其转变为融块的过程。小血管的凝固足以使其永久闭合,而较大的血管则需要密封才能保证永久闭合。组织焊接是一门用于闭合伤口和血管的技术,并在许多外科手术专业中应用。组织焊接技术通过在伤口或血管中产生止血密封以及在组织中产生强力吻合来闭合伤口。可以利用超声外科手术器械,以在对组织造成的侧向热损伤最小的情况下实现止血。止血或吻合通过将机械能传送到组织来进行。内部细胞摩擦使氢键断裂,从而导致蛋白质变性。由于蛋白质在低于100℃的温度下变性,因此会形成粘性凝块并密封小血管。当该效应延长时就进行吻合。因此,可利用振荡刀片中的超声能量在伤口中的血管和相邻组织中产生止血密封并在组织中产生强力吻合。超声振动的单个或多个端部执行器单独地或结合夹持机构能产生足够的机械能来密封血管,而无论端部执行器和/或组织的温度如何。为产生强力的组织吻合,应当将端部执行器和组织的温度维持在大约50℃以下,以允许产生凝块,以在不干燥组织的情况下密封组织。
在医疗器械的设计中,可以应用若干因素以评估具体设计的人体工程学可行性。人体工程学的一个因素是舒适度。舒适度的特征可以在于在未造成过度肌肉拉紧、压力点或其他有害人体工程学效应的情况下操纵和控制装置的能力。适当确定为贴合使用者解剖学而定位的部件尺寸,并靠着使用者身体施加足够的分配力,由此可以建立舒适度。舒适度通过无疲劳、疼痛或精度丧失地长期使用器械的能力来衡量。人体工程学的另一个因素是无疲劳、疼痛或精度丧失地长期使用器械的能力,这个能力通过舒适度来衡量。除舒适度之外,一个客观因素是在轻松完成外科手术任务所需的控制度下控制装置工作端的能力。可以实现的此控制的程度首先源自器械在使用者手中的固有稳定性,其次来自执行更精细运动以操纵具体器械控件的能力。设计工作平衡了为适当触及和灵活使用精细控件提供便利的同时实现整体手持稳定性的能力。外科手术器械的手持稳定性可以通过多种握把来实现。除了别的以外,常见握把包括环形柄部、内嵌式剪和枪式构型。手枪式握把通常提供手上的固定点:
(1)倚靠在拇指与食指之间关节蹼上的点;
(2)拇指与食指之间的握持力;以及
(3)在启动触发器、电源开关、旋钮、杠杆或其他部件时手指与手掌之间的握紧力。
由于外科手术腔体的固有空间因素,使用穿过套管插入患者体内的内窥镜器械进行常规外科手术方法时,外科医生通常会遇到困难。许多内窥镜器械(尤其是腹腔镜超声外科手术器械)的空间限制连同多重功能能力,给外科医生轻易触及和操作器械的多重功能和控件带来了人体工程学方面的挑战。许多具有多重元件端部执行器的超声外科手术器械要求夹持机构的夹钳具有较大的力,继而要求柄部/触发器处具有较大的输入力。这在为使用者提供舒适的柄部/触发器接口方面带来了挑战。同样重要的是,使外科医生能够精细控制夹钳的开口运动,以有利于精细解剖,而不会在外科医生的手上形成疲劳点或压力点。启动超声器械外壳上的电源开关也存在挑战。外科医生需要可轻易触及在任何点处的开关中的任何者,同时也要避免在任何时间意外或无意启动。外科医生需要执行的其他功能包括旋转轴或选择功率电平。此外,使用者应当能够在不观看的情况下操作这些功能中的任何者,从而允许在腹腔镜手术期间完全专注于显示器画面。此外,可能理想的是使用者不必重新定位其握把以便操作这些关键功能和电源开关中的任何者,并且能够在开启端部执行器夹持机构夹钳时轻易操纵夹持力和功率电平。
常规腹腔镜超声外科手术器械呈现的其他人体工程学挑战包括使用者轻易触及和操作多重功能(有时同时进行)的能力。食指通常用于操作位于装置柄部远端的旋钮以旋转轴。然而,控制电源按钮/开关还涉及食指的使用,从而在将旋钮和开关设置在外壳上使得它们均可由食指触及方面带来了固有困难。超声装置包括多个必须在不同手部位置可触及并且适合多种手部大小的控件,例如轴旋转、功率设置和触发器闭合。
常规腹腔镜超声外科手术器械通常具有位于器械远端的旋转控制旋钮,其可由食指触及以旋转轴。然而,控制电源按钮/开关还涉及食指的使用,因此在将旋钮和开关设置在外壳上使得它们均可由食指触及方面带来了固有困难。手小的外科医生通常难以触及指尖旋转式控件,尤其是在器械取向为将器械末端定位在接近待处理解剖学结构处所必需的极端角度或取向的位置上时。
相对于手部大小,制造柄部设计在尺寸、形状和控件接口的位置方面对于每个人均“理想”的腹腔镜超声外科手术器械是长久以来所面临的挑战。从纤巧女性到魁梧男性人体测量学的极大视差对于处于视差范围极端的使用者形成挑战。尽管已考虑具有各种不同尺寸柄部的器械以适应不同手部大小,但购买者通常期望保有较少库存,因此没有接受多重变型形式。此外,始终存在某个尺寸的柄部可能不适用于具体医院的具体医生的风险。
许多超声外科手术器械(尤其是腹腔镜超声外科手术器械)的多重功能能力在使用者舒适地触及和操作器械的多重功能和控件的能力方面形成人体工程学方面的挑战。这包括(例如)舒适地启动夹持机构的夹钳以及启动手控按钮/开关(有时同时进行)的能力。使用者应当能够控制端部执行器的开启运动以有利于展开解剖。腹腔镜柄部接口设计在常规上整合了“剪”型环以允许此向外运动,从而使用拇指的向外移动阻止“锚定的”手指。然而,这样不能对末端提供最佳控制。一些常规超声外科手术器械可以包括整合了触发器的手枪式握把,其中触发器由使用者的食指和中指向外推,同时将握把保持在柄托上,然而,这样可能造成疲劳和手部紧张。然而,在腹腔镜手术期间进行精细解剖时这种向外运动可能是必要的。手枪式握把样式的柄部可为外科医生提供舒适度、便利性和稳定性。然而,常规手枪式握把样式的柄部对于解剖来说可能并非最佳,相反,很多外科医生偏好剪式握把风格的设计来进行解剖。
因此,需要用于超声外科手术器械的人体工程学柄部组件,这种组件可提供使用者舒适地触及和操作多重功能的能力。此外,需要用于超声外科手术器械的柄部组件,这种组件让使用者能够舒适地启动夹持机构的夹钳以及启动手控按钮/开关。也需要在人体工程学舒适度、稳定性和较大范围手部大小的可控制性方面优化柄部组件。
发明内容
在一个实施例中,外科手术器械柄部组件包括具有近端和远端的外壳。近侧开口在外壳的近端处形成。远侧开口在外壳的远端处形成。近侧开口和远侧开口限定纵向轴线。柄部从纵向轴线向下地延伸。柄部限定近侧接触表面、鞍形表面和稳定性尾部。触发器可枢转地附接到外壳并且能够相对于柄部可枢转地活动。
附图说明
图1为超声外科手术器械的一个实施例的右侧视图。
图2为图1所示超声外科手术器械在没有超声换能器时的一个实施例的右侧视图。
图3为超声外科手术器械的一个实施例的左透视图,示出了外壳、远侧旋转组件、细长内窥镜轴组件和端部执行器组件。
图4为图3所示超声外科手术器械的左侧视图。
图5为图3所示超声外科手术器械的一个实施例的顶视图。
图6为图3所示超声外科手术器械的一个实施例的底视图。
图7为图3所示超声外科手术器械的一个实施例的前视图。
图8为图3所示超声外科手术器械的一个实施例的后视图。
图9为图3所示超声外科手术器械的一个实施例的放大前视图。
图10为图3所示超声外科手术器械的端部执行器组件部分的一个实施例的左透视图。
图11为图3所示超声外科手术器械的端部执行器组件部分的一个实施例的左透视图。
图12为图3所示超声外科手术器械的端部执行器组件部分的一个实施例的右侧视图。
图13为图3所示超声外科手术器械的一个实施例的左透视图,示出了中心轴“T”。
图14为图3所示超声外科手术器械的分解图。
图15为图3所示柄部组件的一个实施例的右半部分的左透视图。
图16为图3所示柄部组件的一个实施例的右半部分的右透视图。
图17为图3所示柄部组件的一个实施例的右半部分的左侧视图。
图18为图3所示柄部组件的一个实施例的右半部分的右侧视图。
图19为图3所示柄部组件的一个实施例的右半部分的局部剖视顶视图。
图20为图3所示柄部组件的一个实施例的右半部分的局部剖视底视图。
图21为图3所示柄部组件的一个实施例的右半部分的局部剖视前视图。
图22为图3所示柄部组件的一个实施例的右半部分的局部剖视底视图。
图23为图3所示超声外科手术器械的一个实施例的左透视图。
图24为图3所示超声外科手术器械的一个实施例的剖视左透视图。
图25示出了图3所示柄部组件的一个实施例的各种使用者接口之间的关系。
图26示出了图3所示柄部组件的一个实施例的各种使用者接口之间的关系。
图27示出了超声外科手术器械的一个实施例。
图28为包括近侧旋钮的超声外科手术器械的一个实施例的右侧视图。
图29为图28所示超声外科手术器械的一个实施例的放大右透视图。
图30为包括近侧旋转组件的超声外科手术器械的一个实施例的右侧视图。
图31为图30所示超声外科手术器械的一个实施例的右侧视图,其中近侧旋转组件和超声换能器与外壳分离。
图32为图30和图31所示的、与超声换能器分离的近侧旋转组件的右侧视图。
图33为用于包括近侧旋转组件和远侧旋转组件两者的超声外科手术器械的柄部组件的一个实施例的左侧视图。
图34为图33所示柄部组件的一个实施例的局部放大左透视图。
图35示出了超声外科手术器械的柄部组件的一个实施例的局部剖视图。
图36为图35所示柄部组件的外壳内摇臂开关和往复式托架组件的一个实施例的局部放大视图。
图37为用于包括近侧旋转组件和远侧旋转组件两者的超声器械的柄部组件的一个实施例的右外壳部分的右透视图,其中外壳的左外壳部分被移除。
图38为图37所示柄部组件的一个实施例的右外壳部分的左透视图,其中外壳的左外壳部分被移除。
图39为图37所示柄部组件的一个实施例的右外壳部分的左侧视图,其中外壳的左外壳部分被移除。
图40为图37所示柄部组件的一个实施例的右外壳部分的侧视图,其中左外壳部分被移除。
图41为图39所示柄部组件的一个实施例的右外壳部分沿线条41-41截取的顶视图。
图42为图39所示柄部组件的一个实施例的右外壳部分沿线条42-42截取的底视图。
图43为图41所示柄部组件的一个实施例的右外壳部分沿线条43-43截取的前视图。
图44为图41所示柄部组件的一个实施例的右外壳部分沿线条44-44截取的后视图。
图45示出了图37-44所示近侧旋转组件的一个实施例的分解图。
图46为图45所示近侧旋转组件的一个实施例的侧视图。
图47为图46所示近侧旋钮的一个实施例沿线条47-47截取的后视图。
图48为图46所示近侧旋钮的一个实施例沿线条48-48截取的前视图。
图49为图46所示圆柱形基底的一个实施例沿线条49-49截取的前视图。
图50为图46所示圆柱形基底的一个实施例沿线条50-50截取的后视图。
图51为图37-44所示远侧旋转组件的一个实施例的透视图。
图52为图51所示远侧旋转组件的一个实施例的透视图。
图53为图51所示远侧旋转组件的一个实施例的第一顶视图。
图54为图53所示远侧旋转组件的一个实施例旋转45°的第二顶视图。
图55为图54所示远侧旋转组件的一个实施例沿线条55-55截取的后视图。
图56为图53所示远侧旋转组件的一个实施例的沿线条56-56截取的前视图。
图57为图37-44所示远侧旋转组件的一个实施例的局部右透视图,远侧旋转组件以机械方式接合到左外壳部分的远端。
图58为超声外科手术器械的柄部组件的一个实施例的右侧透视图,柄部组件适于接纳柄部适配器。
图59为图58所示柄部组件的一个实施例和柄部适配器的一个实施例的右侧透视图。
图60为图58-59所示柄部组件的一个实施例的右侧透视图,柄部组件包括附接到其上的图59所示柄部适配器。
图61为柄部适配器的一个实施例的右透视图,柄部适配器包括适于附接到超声外科手术器械的柄部组件的卡扣部件。
图62为包括图61所示卡扣部件的柄部适配器的一个实施例的左透视图。
图63为包括图62所示卡扣部件的柄部适配器的一个实施例的左侧视图。
图64为包括图61所示卡扣部件的柄部适配器的一个实施例的右侧视图。
图65为包括图63所示卡扣部件的柄部适配器的一个实施例沿线条65-65截取的前视图。
图66为包括图63所示卡扣部件的柄部适配器的一个实施例沿线条66-66截取的后视图。
图67为包括图65所示卡扣部件的柄部适配器的一个实施例沿线条67-67截取的顶视图。
图68为包括图66所示卡扣部件的柄部适配器的一个实施例沿线条68-68截取的底视图。
图69为包括图61所示卡扣部件的柄部适配器的一个实施例的后透视图。
图70示出了包括套环柄部适配器组件的超声外科手术器械的柄部组件的一个实施例。
图71为图70所示套环柄部适配器组件的前透视图。
图72为图71所示套环柄部适配器组件的后透视图。
图73为图71所示套环柄部适配器组件的左透视图。
图74为图71所示套环柄部适配器组件的右透视图。
图75为图71所示套环柄部适配器组件的右侧视图。
图76为图71所示套环柄部适配器组件的左侧视图。
图77为图75所示套环柄部适配器组件沿线条77-77截取的前视图。
图78为图76所示套环柄部适配器组件沿线条78-78截取的后视图。
图79为图77所示套环柄部适配器组件沿线条79-79截取的顶视图。
图80为图78所示套环柄部适配器组件沿线条80-80截取的底视图。
图81为图71-80所示套环适配器的一个实施例的左透视图。
图82为图71-80所示套环适配器的一个实施例的前透视图。
图83为图71-80所示套环柄部组件的柔性元件部分的一个实施例的后透视图。
图84为图83所示柔性元件的一个实施例的右侧视图。
图85为图83所示柔性元件的一个实施例的左侧视图。
图86为图84所示柔性元件的一个实施例沿线条86-86截取的前视图。
图87为图85所示柔性元件的一个实施例沿线条87-87截取的后视图。
图88示出了超声外科手术器械的柄部组件的一个实施例,柄部组件包括在固定的柄部的后部或近侧位置形成的弯曲稳定性突出。
图89示出了超声外科手术器械的柄部组件的一个实施例,柄部组件包括在固定的柄部的两侧形成的凸起。
图90示出了超声外科手术器械的柄部组件的一个实施例,柄部组件包括在固定的柄部的两侧形成的凸起。
具体实施方式
在详细阐述各种实施例之前,应该指出的是,这些实施例的应用或使用并不局限于附图和具体实施方式中详细示出的部件的构造和布置。示例性实施例可以单独实施,也可以与其他实施例、变更形式和修改形式结合在一起实施,并可以通过多种方式实施或执行。例如,下文所公开的外科手术器械、柄部组件、柄部适配器以及与其关联的其他组件仅出于示例性目的,而并非意图限制其范围或应用。此外,除非另外指明,否则本文所用的术语和公式是为了方便读者而对示例性实施例进行描述目的所选的,并非限制其范围。
可认识到,本文结合临床医生握住超声外科手术器械的柄部组件柄部的情况来使用术语“远侧”和“近侧”。因此,端部执行器相对于更近侧的柄部为远侧。还应该理解,为方便和清晰的目的,本文还相对于临床医生握住柄部的情况使用(例如)“顶部”和“底部”的空间术语。然而,外科手术器械可以在许多取向和位置使用,并且这些术语并非意图是限制的和绝对的。术语“右”是指从使用者的角度从远端向近端朝器械“前部”观察时器械的右侧。术语“左”是指从使用者的角度从远端向近端朝器械“前部”观察时器械的左侧。术语“后”是指从使用者的角度从器械近端向远端观察时器械的使用者后部。
各种实施例整体涉及具有改善的多重功能能力和人体工程学控制部件以在腹腔镜手术和/或常规开放式外科手术中使用的超声外科手术器械。相对于超声外科手术器械的各种实施例描述的人体工程学部件可增强使用者轻易舒适地触及和操作位于器械上多重位置中的器械的多重功能的能力,以便在外科医生执行临床任务时使精确度和控制水平最大化。
本文所述超声外科手术器械的各种实施例包括与使用者柄部和触发器接口相关的舒适的和人体工程学的控制部件。在要求端部执行器的夹钳之间具有非常大夹持力的应用中,这可以缓解压迫和疲劳。人体工程学部件可轻松控制夹钳的开启运动,有利于各种外科手术,如精细解剖。提供电源开关以启动超声换能器组件。这些开关可以用手操作,使得使用者可以轻易触及位于任何点的电源开关中的一个或多个,同时避免在任何时间意外或无意启动。开关包括让使用者能够在不进行观察的情况下选择正确开关的部件。相似地,可轻松触及轴的旋转控件。这允许使用者在(例如)腹腔镜手术期间能够完全专注于显示器画面。使用者在没有重新定位器械上的夹钳的情况下可以启动开关。使用者可以在轻松控制供电,同时开启端部执行器的夹钳。在一个实施例中,电源开关可以实施为MIN/MAX摇臂样式或“拨动”样式的开关。在向前位置,MIN/MAX拨动开关提供可轻易触及的接触表面突出以用于启动电源,而无需重新定位把手,使其适于维持控制并将注意力集中在外科手术现场(如腹腔镜手术中的显示器)。
已经长期需要得到这样的外科手术器械柄部,其在尺寸、形状和控制接口的位置方面适于适应纤巧女性到魁梧男性以及不同种族的人体测量学的很大视差。如预期的那样,处于范围中这些极端的使用者使用常规大小设置的器械柄部时有困难。因此,各种实施例为外科手术器械提供了适于适合范围大得多的手部大小的柄部组件。各种实施例提供设计更加优化的人体工程学部件,以用于在使用期间舒适地控制外科手术器械。本文提供了多重人体工程学柄部适配器的实施例。
现在将描述某些实施例,从而得到对本文公开的装置和方法的结构、功能、制造和使用原理的综合理解。这些实施例中的一个或多个实例在附图中示出。本领域的普通技术人员将会理解,本文特别描述和在附图中示出的器械和方法为非限制性的实施例,并且各种实施例的范围仅受权利要求书限定。结合一个实施例进行图解说明或描述的部件可与其他实施例的部件进行组合。这种修改形式和变化形式旨在包括在权利要求书的范围之内。
图1-25示出了适用于内窥镜手术或常规开放式外科手术的超声外科手术器械的一个实施例。在图1-25所示实施例中,外科手术器械包括用于腹腔镜手术和/或常规开放式外科手术的经过改进的多重功能能力和人体工程学部件。外科手术器械的人体工程学部件增强了使用者轻易触及和操作外科手术器械的多重功能和控件的能力。多功能超声外科手术器械的人体工程学部件让使用者能够轻易触及和操作器械的多重功能和控件。
在一个实施例中,器械包括柄部组件,柄部组件包括位于柄部组件远端的旋钮。使用者可以使用手指操作远侧旋钮。旋钮以机械方式接合到超声传输波导轴,波导轴连接到端部执行器组件的夹持机构。因此,使用者可以用手指旋转远侧旋钮,以适当地取向端部执行器组件夹持机构夹钳。
在一个实施例中,柄部组件包括摇臂开关以控制为超声换能器供电的电源。在一个实施例中,摇臂开关在最大(MAX)设置功率和最小(MIN)设置功率之间枢转。MIN/MAX摇臂开关适当地位于柄部组件的固定的柄部上,从而摇臂开关可以由操作远侧旋钮的相同手指操作。然而,按钮开关可以位于器械的移动部件上,例如触发器。因此,相同的手指可用于旋转轴和操作电源启动。摇臂开关可以包括识别触觉部件。
在一个实施例中,包括钩部件的可枢转移动的触发器可以用于启动端部执行器组件的夹钳或夹持机构。一系列联接将触发器的枢转转化为连接到启动机构的托架的轴向移动,启动机构控制位于超声外科手术器械远端的端部执行器组件夹持机构夹钳的打开和闭合。在一个实施例中,可以采用多个联接,从而在相对较短的枢转跨度中得到机械优势。触发器可以由用于控制远侧旋钮或拨动开关的手指之外的手指操作。启动触发器的手指也可以用于接合钩部件,以将端部执行器组件夹持机构夹钳恢复至预定状态。
在一个实施例中,旋钮可以位于超声外科手术器械的近端。近侧旋钮可以由拇指或其他手指轻易触及,并且实质上可减少可能与位于远侧的旋钮相关的任何障碍或“延伸”。
在一个实施例中,旋钮可以位于超声外科手术器械的远端和近端。为了方便起见,远侧旋钮和近侧旋钮可以由拇指或其他手指轻易触及。此外,拇指动作和替代使用的其他手指动作的相对本质几乎完全减少了向超声换能器供电的电线的卷绕。使用者的自然趋向是仅在朝下方向旋转,因为向下推动比向上推动更容易。由于旋钮位于远侧和近侧两者,因此右手使用者可使用近侧旋钮向下推动以向左旋转,而使用远侧旋钮向下推动以向右旋转,从而减少或消除仅在一个方向旋转造成的“缆线卷绕”。远侧旋钮和近侧旋钮可以彼此结合操作,也可以独立旋转。
在各种实施例中,可以提供多重适配器以适应不同大小的手。适配器可以包括开启的近端,并且可以摩擦方式或通过按扣可拆卸地附接到柄部组件的固定的柄部。适配器可以包括闭合的近端,以形成套环用于接纳从其中穿过的拇指。套环适配器的各种实施例包括柔性聚合物元件以用于增加舒适度。
在一个实施例中,柄部组件可以包括在柄部组件的固定的柄部上形成的凸起。在另一个实施例中,柄部组件可以包括在柄部组件的固定的柄部的任一侧形成的凸起。在操作器械的同时使用某些超声外科手术器械时,这些突起和凸起会减轻或最小化疲劳,并且提高控制度。
图1为超声外科手术器械100的一个实施例的右侧视图。在图示实施例中,超声外科手术器械100可以用于多种外科手术,包括内窥镜手术或常规开放式外科手术。在一个实施例中,超声外科手术器械100包括柄部组件102、细长内窥镜轴组件110和超声换能器114。柄部组件102包括触发器组件104、远侧旋转组件106和开关组件108。细长内窥镜轴组件110包括端部执行器组件112,该端部执行器组件包括用于解剖组织或互相握持、切割和凝结血管和/或组织的元件,以及用于启动端部执行器组件112的启动元件。柄部组件102适于在近端接纳超声换能器114。超声换能器114以机械方式接合到细长内窥镜轴组件110和端部执行器组件112的部分。超声换能器114通过电缆118电连接到发生器116。尽管大多数附图示出了结合内窥镜外科手术使用的多重端部执行器组件112,但超声外科手术器械100可以用于更为常规的开放式外科手术。出于本文的目的,从内窥镜器械的角度来描述超声外科手术器械100;然而,可以构思,开放型超声外科手术器械100也可以包括如本文所述相同或相似的操作组件和部件。
图2为图1所示超声外科手术器械100在没有超声换能器114时的一个实施例的右侧视图。在图示实施例中,触发器组件104包括结合固定的柄部122使用的触发器120。固定的柄部122和触发器120以符合人体工程学的方式形成并且适于与使用者舒适地接触。固定的柄部122与柄部组件102整体相连。触发器120能够相对于固定的柄部122可枢转地移动,下文相对于超声外科手术器械100的操作将更为详细地对此进行说明。使用者抵靠触发器120施加挤压力时,触发器120能够在方向121A朝固定的柄部122可枢转地移动。使用者释放抵靠触发器120的挤压力时,弹簧元件182(图14)使触发器120在方向121B可枢转地移动。
在一个实施例中,触发器120包括细长触发器钩124,该细长触发器钩限定细长触发器钩124与触发器120之间的孔126。孔126的大小设置为适合接纳使用者从其中穿过的一根或多根手指。触发器120也可以包括在触发器120基底上模制的弹性部分120a。形成包覆成型弹性部分120a,从而得到更加舒适的接触表面,以在朝外方向121B控制触发器120。在一个实施例中,包覆成型的弹性部分120a可以设置在细长触发器钩124的一部分的上方。例如,在图示实施例中,包覆成型的弹性部分120a设置在细长触发器钩120内部的远侧和顶部表面的上方,以缓冲手指与细长触发器钩124之间的接触表面。细长触发器钩120的近侧表面保持为未涂覆或涂覆有非弹性基底,以便使用者能够轻易地将手指滑入和滑出孔126。在其他实施例中,细长触发器钩124可以包含由柔韧的、有弹性的、柔性聚合材料(包括(例如)GLSCorporation制造的TPE合金)形成的包覆成型元件。细长触发器钩124的包覆成型弹性部分120a可以为使用者提供增加的舒适度或形成更加牢固的握持。可以设置细长触发器钩124内部的顶部上的包覆成型弹性部分120a的轮廓以缓解手指进入孔126时抵靠手指的边缘压力点。在另一个实施例中,触发器的几何形状形成完全闭合的套环,其可限定大小设置合适的孔用于接纳从其中穿过的使用者的一根或多根手指。完全闭合的套环触发器也可以包括在触发器基底的上方模制的弹性部分。形成包覆成型弹性部分,从而得到更加舒适的接触表面,以用于在向外方向控制触发器。
在一个实施例中,固定的柄部122包括近侧接触表面128和夹具锚或鞍形表面130。鞍形表面130倚靠在手上拇指和食指结合的蹼上。近侧接触表面128具有手枪式握把轮廓,其在没有环或孔的普通手枪式握把上接纳手掌。可以设置近侧接触表面128的轮廓曲线以适应或接纳手掌。为了在使用超声器械100时提供舒适度和控制度,优化近侧接触表面128的轮廓以贴合掌心凹处和拇指根部的自然解剖学轮廓。鞍形表面130提供握把的主要稳定点,该点为柄部组件102的控制稳定性的基础。鞍形表面130是确定手指和拇指相对于固定的柄部122的远侧接触表面128、细长触发器钩124、远侧旋转组件106和拨动开关132的运动范围的参考点。稳定性尾部131位于朝向柄部组件102更近侧部分。稳定性尾部131可以与位于拇指与食指之间的手部最上方蹼部分接触,以稳定柄部组件102以及使柄部组件102更可控制。稳定性尾部131提供在近侧方向延伸的区域,以允许超声外科手术器械100的近侧重量分布到手的顶部而不限制运动。鞍形表面130和稳定性尾部131的构型为使用者在操纵柄部组件102时提供更高的稳定感、舒适度和控制度。
在一个实施例中,开关组件108可以包括拨动开关132。拨动开关132可以实施为位于柄部组件102的内部内的具有中心枢轴304(图34)的单个元件,以消除同时启动的可能性。在一个实施例中,拨动开关132包括第一突出旋钮132a和第二突出旋钮132b,以在最小功率电平(如MIN)和最大功率电平(如MAX)之间设置超声换能器114的设置功率。在第一突出旋钮132a和第二突出旋钮132b被启动时,拨动开关132绕中心枢轴304旋转。一个或多个突出旋钮132a、132b连接到一个或多个臂,该一个或多个臂移动通过小弧并且使电触点(如图36所示电元件172b)根据第一突出旋钮132a或第二突出旋钮132b的启动情况来开启或闭合电路,以使超声换能器114通电或断电。拨动开关132连接到发生器116以控制超声换能器114的启动。拨动开关132包括一个或多个电源设置开关以启动超声换能器114,以为超声换能器114设置一个或多个设置功率。启动拨动开关132所需的力被导向为大致朝向鞍形点130,从而避免拨动开关132启动时器械在手中旋转的任何趋势。
在一个实施例中,第一突出旋钮132a和第二突出旋钮132b位于柄部组件102的远端,使得使用者可轻易触及它们,从而在最低程度或基本上无需重新定位握把的情况下启动电源,因而适于在启动拨动开关132时维持控制并保持注意力集中到外科手术现场(如腹腔镜手术中的显示器)。突出旋钮132a、132b可以被构造为卷绕柄部组件102的侧面至一定程度,以便更易于被不同长度的手指触及,并且在不顺手位置启动或手指较短时具有较大的触及自由度。
在一个实施例中,第一突出旋钮132a和第二突出旋钮132b可以由柔韧的、有弹性的、柔性聚合材料(包括(例如)GLS Corporation制造的TPE合金)包覆成型。可以选择包覆成型的材料以经受消毒以及能够生物相容。此外,可以选择具有适当弹性级别以及可对外科手术手套提供足够摩擦阻力的材料。包覆成型部分可以包括具有识别触觉部件的突出,该部件用于对突出旋钮132a、132b或柄部组件102的其余部分进行触觉识别或区别。如此前所讨论,突出旋钮132a、132b中的一个可以包括让使用者能够区分第一突出旋钮132a和第二突出旋钮132b的纹理或触觉表面。在图示实施例中,第一突出旋钮132a包括多个触觉元件132c,如所示实施例中的纹理突出或“凸耳”,以允许使用者区分第一突出旋钮132a(MAX)和第二突出旋钮132b(MIN)。
在一个实施例中,拨动开关132可以由使用者的手操作。使用者可以轻易触及位于任何点的第一突出旋钮132a和第二突出旋钮132b,同时也避免在任何时间意外或无意启动。拨动开关132可以方便地由手指操作以控制传输至超声组件114和/或超声组件114的电力。例如,食指可以用于启动第一接触部分132a以将超声组件114接通到最大(MAX)功率电平。食指可以用于启动第二接触部分132b以将超声组件114接通到最小(MIN)功率电平。可以在不观察第一突出旋钮132a或第二突出旋钮132b的情况下操作拨动开关132。这允许使用者在腹腔镜手术期间完全专注于显示器画面。因此,第一突出旋钮132a或第二突出旋钮132b可以包括纹理或突出,因而无需观察即可以触觉方式区分第一突出旋钮132a和第二突出旋钮132b。例如,在图示实施例中,第一突出旋钮132a包括多个触觉元件132c,以允许使用者以触觉方式区分第一突出旋钮132a(MAX)和第二突出旋钮132b(MIN)。可以在第一突出旋钮132a或第二突出旋钮132b中的任何一个上形成其他触觉纹理或元件以达到区分两者的目的。使用者不必重新定位其握把便可操作拨动开关132,并且可在轻松控制功率电平时开启端部执行器112的夹钳。
在一个实施例中,远侧旋转组件106可绕纵向轴线“T”(图13)在任意方向不受限制地旋转。远侧旋转组件106以机械方式接合到细长内窥镜轴组件110。远侧旋转组件106位于柄部组件102的远端。远侧旋转组件106包括圆柱形毂133和在毂133上形成的旋钮134。毂133以机械方式接合到细长内窥镜轴组件110。旋钮134可以包括凹槽型聚合物部件,并且可以用手指(如食指)接合以旋转细长内窥镜轴组件110。毂133可以包括在主结构上模制的材料以形成旋钮134。旋钮134可以在毂133上包覆成型。毂133包括在远端露出的端盖部分133a。在腹腔镜手术期间,毂133的端盖部分133a可以接触套针的表面。毂133可以由(例如)聚碳酸酯的硬质耐用塑料形成以缓解端盖部分133a与套针之间可能出现的任何摩擦。旋钮134可以包括由突肋134a形成的“扇形凹口”或凹槽以及位于肋134a之间的凹面部分134b,从而得到更加精确的旋转握持。在一个实施例中,旋钮134可以包括多个凹槽(如三个或更多个凹槽)。在其他实施例中,可以采用任何适合数量的凹槽。旋钮134可以由在硬质塑性材料上包覆成型的较软聚合材料形成。例如,旋钮134可以由柔韧的、有弹性的、柔性聚合材料(包括(例如)GLS Corporation制造的TPE合金)形成。这种较软的包覆成型材料可以提供更好的握持,也可以更加精确地控制旋钮134的移动。可认识到,任何可经受消毒处理、生物相容和对外科手术手套提供足够摩擦阻力的材料都可以用于制备旋钮134。
在一个实施例中,柄部组件102可以包括人体工程学部件并且可以由人体工程学部件构建,以便使用者能够轻易触及和操作超声外科手术器械100的多重功能和控件。因此,可以使用手指操作位于柄部组件102的远侧部分的远侧旋钮134。旋钮134通过毂133连接到超声传输波导轴的细长内窥镜轴组件110。因此,手指可用于通过旋转旋钮134来旋转超声传输波导的细长内窥镜轴组件110。拨动开关132的MIN/MAX电源按钮适当地位于器械100的柄部组件122的远端,以使得它们可以由(例如)食指来操作。因此,食指可以用于旋转细长内窥镜轴组件110的轴来将端部执行器组件112夹持机构夹钳取向为所需位置并将超声换能器114开启至合适的功率电平。
图3为超声外科手术器械100的一个实施例的左透视图,示出了柄部组件102、远侧旋转组件106、细长内窥镜轴组件110和端部执行器组件112。参见图3-9,在图示实施例中,细长内窥镜轴组件110包括尺寸设置为以机械方式接合端部执行器组件112的远端138以及以机械方式接合柄部组件102和远侧旋转组件106的近端136。细长内窥镜轴组件110的近端136接纳在柄部组件102和远侧旋转组件106内。图14和图24的描述中提供了涉及细长内窥镜轴组件110、柄部组件102和远侧旋转组件106之间连接的更多细节。
在一个实施例中,柄部组件102由包括第一部分102a和第二部分102b的两(2)个外壳部分或护罩形成。从使用者的角度从远端朝近端观察柄部组件102,第一部分102a被视为右侧部分,第二部分102b被视为左侧部分。第一部分102a和第二部分102b中的每一个包括多个接口158(图14),接口的尺寸设置为彼此以机械方式对准并接合以形成柄部组件102并且封闭其内部工作元件。与柄部组件102整体相连的固定的柄部122在组装柄部组件102的第一部分102a和第二部分102b后成形。可以在柄部组件102的第一部分102a和第二部分102b的周边周围的多个点处设置多个额外的接口(未示出),如能量方向点/挠曲点,以用于超声焊接的目的。可以按本领域已知的方式将第一部分102a和第二部分102b(以及下文所述其他元件)组装在一起。例如,定位销、按扣型接口、舌状物接口和凹槽接口、锁定接片、粘结端口可以单独或组合用于组装目的。
在一个实施例中,细长内窥镜轴组件110包括适于以机械方式接合柄部组件102和远侧旋转组件106的近端136;以及适于以机械方式接合端部执行器组件112的远端138。细长内窥镜轴组件110包括外管状护套142和位于外管状护套142内的往复式管状启动构件144。管状往复式管状启动构件144的近端以机械方式接合到柄部组件102的触发器120,以响应触发器120的启动和/或释放而在方向146A或146B移动。可枢转移动的触发器120可以用于启动端部执行器组件112的夹钳或夹持机构。一系列联接将触发器120的枢转转化为连接到启动机构的托架的轴向移动,启动机构控制端部执行器组件112夹持机构夹钳的打开和闭合。往复式管状启动构件144的远端以机械方式接合到端部执行器组件112。在图示实施例中,管状启动构件144的远端以机械方式接合到可绕枢转点154枢转的夹臂组件150,以响应触发器120的启动和/或释放而打开和闭合夹臂组件150。例如,在图示实施例中,当触发器120在方向121A受到挤压时,夹臂组件150绕枢转点154在方向148A可从打开位置移动到关闭位置。当触发器120在方向121B释放或向外接触时,夹臂组件150绕枢转点154在方向148B可从关闭位置移动到打开位置。
在一个实施例中,端部执行器组件112在细长内窥镜轴组件110的远端138处连接,并且包括夹臂组件150和刀片152。端部执行器组件112夹持机构夹钳由夹臂组件150和刀片152形成。刀片152可以超声方式启动并以声学方式耦合到超声换能器114。柄部组件102上的触发器120最终连接至驱动组件,其共同以机械方式配合以进行夹臂组件150的移动。在方向121A挤压触发器120使夹臂组件150在方向148A从打开位置移动到夹持或关闭位置,在打开位置,夹臂组件150和刀片152相对于彼此间隔设置,在夹持或关闭位置,夹臂组件150和刀片152配合以夹持其间的组织。夹臂组件150可以包括夹持垫158以接合刀片152与夹臂150之间的组织。在方向121B释放触发器120使夹臂组件150在方向148B从关闭位置移动到打开位置,在打开位置,夹臂组件150和刀片152相对于彼此间隔设置。
柄部组件102的近侧部分包括近侧开口156以接纳超声组件114的远端。超声组件114插入近侧开口156并且以机械方式接合到细长内窥镜轴组件110。
在一个实施例中,触发器120的细长触发器钩124部分提供较长的触发器杠杆以及较短的跨度和旋转行程。细长触发器钩124的较长杠杆允许使用者在孔126内使用多根手指来操作细长触发器钩124,并且使触发器120在方向121B枢转以打开端部执行器组件112的夹钳。例如,使用者可以将三根手指(如中指、无名指和小指)插入孔126中。多根手指使得外科医生可在触发器120和细长触发器钩124上施加较大的输入力来启动端部执行器组件112。当在方向121A闭合或挤压触发器120或在方向121B通过向外开启运动开启触发器120时,较短的跨度和旋转行程产生更舒适的握持,从而减少进一步向外伸出手指的需求。这将显著减轻在方向121B与触发器120向外开启运动相关的手部疲劳和紧张。触发器的向外开启运动可以由弹簧元件182(图14)弹簧协助以有助于缓解疲劳。开启弹簧力足以协助轻易地开启,但不足以在展开解剖期间对组织张力的触觉反馈造成不利影响。
例如,在外科手术期间,任意食指可以用于控制细长内窥镜轴组件110的旋转,以将端部执行器组件112的夹钳定位在合适的取向上。中指和/或其他较短手指可以用于挤压触发器120和抓握夹钳内的组织。一旦夹钳位于所需位置并且夹钳夹住组织,食指就可用于启动拨动开关132以调整超声换能器114的功率电平以处理组织。一旦已经处理了组织,使用者就可以使用中指和/或其他较短手指抵靠细长触发器钩124沿远侧方向向外推动来释放触发器120,以打开端部执行器组件112的夹钳。使用者不必调整其柄部组件102的握把即可执行此基本过程。
图10-12示出了细长内窥镜轴组件110相对于端部执行器组件112的连接。如前所述,在图示实施例中,端部执行器组件112包括夹臂组件150和刀片152以形成夹持机构的夹钳。刀片152可以为以声学方式耦合到超声换能器114的可超声启动刀片。触发器120以机械方式连接至驱动组件。触发器120和驱动组件共同以机械方式配合以在方向148B将夹臂组件150移动到打开位置,在该位置夹臂组件150和刀片152相对于彼此间隔设置,并且在方向148A将夹臂组件移动到夹持或关闭位置,在该位置夹臂组件150和刀片152配合以夹持其间的组织。夹臂组件150可以包括夹持垫158以接合刀片152与夹臂150之间的组织。管状往复式管状启动构件144的远端以机械方式接合到端部执行器组件112。在图示实施例中,管状往复式管状启动构件144的远端以机械方式接合到可绕枢转点154枢转的夹臂组件150,以在触发器120启动和/或释放时打开和闭合夹臂组件150。例如,在图示实施例中,在方向121A挤压触发器120时,夹臂组件150绕枢转点154在方向148A可从打开位置移动到关闭位置。在方向121B释放或向外接触触发器120时,夹臂组件150绕枢转点154在方向148B可从关闭位置移动到打开位置。
图13为图3所示超声外科手术器械的一个实施例的左透视图,示出了中心纵向轴线“T”。
图14为图3所示超声外科手术器械100的分解图。在图示实施例中,分解图示出了柄部组件102的内部元件、柄部组件102、远侧旋转组件106、开关组件108和细长内窥镜轴组件110。现在参见图14-24,在图示实施例中,第一部分102a和第二部分102b配合以形成柄部组件102。第一部分102a和第二部分102b均包括多个接口158,接口尺寸设置为以机械方式彼此对准并接合以形成柄部组件102并且封闭超声外科手术器械100的内部工作元件。旋钮134以机械方式接合到外管状护套142,以使得其可以沿圆形方向140旋转多达360°。外管状护套142位于往复式管状启动构件144的上方,该构件通过多个连接元件160以机械方式接合到柄部组件102并保留在其内。连接元件160可以包括O形环160a、管状套环帽160b、远侧垫圈160c、近侧垫圈160d和螺纹管状套环160e。往复式管状启动构件144位于往复式托架170内,往复式托架保留在柄部组件102的第一部分102a与第二部分102b之间。托架170为往复式托架组件173的一部分。一系列联接将细长触发器钩120的枢转转化为往复式托架170的轴向移动,往复式托架控制超声外科手术器械100远端处的端部执行器组件112夹持机构夹钳的打开和闭合。在一个实施例中,四联接设计提供(例如)在相对短的旋转跨度方面的机械优势。
在一个实施例中,超声传输波导164设置在往复式管状启动构件144内。超声传输波导164的远端138以声学方式耦合到刀片152,超声传输波导164的近端136接纳在柄部组件102内。超声传输波导164的近端136适于以声学方式耦合到超声换能器114的远端,如下文更为详细的讨论。超声传输波导164通过护套166和多个隔离元件168(如硅胶环)与细长内窥镜轴组件110的其他元件隔离。外管状护套142、往复式管状启动构件144和超声传输波导164由销162以机械方式接合。开关组件108包括拨动开关132和电气元件172a、172b,以根据第一突出旋钮132a或第二突出旋钮132b的启动来为超声换能器114供电。
在一个实施例中,外管状护套142将使用者或患者与超声传输波导164的超声振动隔离。外管状护套142通常包括毂163。外管状护套142螺纹连接至柄部组件102的远端。超声传输波导164穿过外管状护套142的开口延伸,隔离元件168将超声传输波导104与外管状护套142隔离。外管状护套142可以通过销162连接至波导164。波导164中接纳销162的洞可以额定方式出现在位移波节处。可以用双头螺栓226(图27)将波导164螺纹连接至或扣入手持式柄部组件102。毂163上的平坦部分可以允许组件扭转至所需程度。
在一个实施例中,外管状护套142的毂163部分优选地由塑料构造,外管状护套142的管状细长部分由不锈钢加工。作为另外一种选择,超声传输波导164可以包括围绕在其周围的聚合材料,以隔离其与外部接触。
在一个实施例中,超声传输波导164的远端可以通过内部螺纹连接连接到刀片152的近端,优选地位于或靠近波腹。可构思刀片152通过(例如)焊接接头或类似方法等任何合适的手段附接到超声传输波导164上。虽然刀片152可以从超声传输波导164上拆卸,但也可构思单个元件端部执行器(如刀片152)和超声传输波导164形成为单体部件。
在一个实施例中,触发器120连接到联接机构以将触发器120在方向121A和121B的旋转运动转化为往复式管状启动构件144在对应方向146A和146B的线性运动。触发器120包括第一凸缘组182,该凸缘具有在其中形成的开口以接纳第一托架销176a。第一托架销176a还穿过在托架170的远端形成的一组开口设置。触发器120还包括第二凸缘组180以接纳联接件176的第一末端176a。触发器销174接纳在联接件176和第二凸缘组180中形成的开口中。触发器销174容纳在联接件176和第二凸缘组180中形成的开口中,并且适于连接到柄部组件102的第一部分102a和第二部分102b以形成用于触发器120的触发器枢转点190(图25、图26)。联接件176的第二末端176b接纳在托架170的近端中形成的狭槽184中,并且由第二托架销178b保留在其中。随着触发器120绕由触发器销174形成的枢转点190枢转,托架在箭头146A、146B指示的方向沿着纵向轴线“T”水平平移。
图25和图26示出了柄部组件102的一个实施例的各种使用者接口之间的关系。在图示实施例中,使用者可以通过控制手指来启动拨动开关132的电源按钮以及控制旋钮134的旋转,并且还可精确控制端部执行器组件112的旋转。控制手指可以为食指,然而实施例并不限于这种情况。如图所示,控制手指位置186a用于操作(如旋转)远侧旋钮134。控制手指位置186a与鞍形表面130之间的距离为“d1”。在一个实施例中,例如d1可以为大约3.17英寸。无需相对于固定的柄部122改变握把,使用者也可以通过将手指放在控制手指位置186b来操作第一突出旋钮132a,以将功率设置为第一电平(如MAX),并且可以通过将手指放在控制手指位置186c来操作第二突出旋钮132b,以将功率设置为第二电平(如MIN)。控制手指位置186b与鞍形表面130之间的距离为“d2”,控制手指位置186c与鞍形表面130之间的距离为“d3”。在一个实施例中,例如d2可以为大约2.55英寸,d3可以为大约2.46英寸。因此,使用者可以在不重新握住柄部组件102的情况下,轻易而方便地将控制手指放在三个控制手指位置186a、186b和186c,以操作各自的远侧旋钮134、第一突出旋钮132a和第二突出旋钮132b。旋转控件和功率控件中的每一个均可由控制手指在不太紧密地挤靠在一起的情况下方便地触及,从而获得所有三个位置的平衡触及。
在一个实施例中,使用者的触发器手指可以位于孔126内的第一位置188a以操作触发器120。第一位置188a与鞍形表面130之间的距离为“d4”。在一个实施例中,例如d4可以为大约2.11英寸。触发器手指可以为中指。如图所示,触发器手指可以接触触发器120的模制弹性部分120a。随着触发器120在方向121A受到挤压,其绕枢转点190从完全打开到完全关闭位置枢转,如图26中的虚线所示。随着触发器120绕枢转点190从完全打开位置到完全关闭位置枢转,触发器手指位置从触发器手指位置188a移动到触发器手指位置188b,如虚线所示。
扩展角定义为触发器120处于完全打开位置时的触发器手指位置188a与位于控制元件上的控制手指之间形成的角度。第一角定义为触发器手指位置188a与接触远侧旋钮134时的控制手指位置186a之间形成的角度。在一个实施例中(例如)可以为大约四十六度。第二角定义为触发器手指位置188a与接触第一突出旋钮132a时的控制手指位置186b之间形成的角度。在一个实施例中(例如)可以为大约三十三度。第三角定义为触发器手指位置188a与接触第二突出旋钮132b时的控制手指位置186c之间形成的角度。在一个实施例中,角可以为大约二十度,控制手指位置188a与轴S之间的角可以为大约十九度。触及扩展度为距离“d”与扩展角的组合,其中“d”为鞍形表面130与控制手指位置186a、186b或186c之间的距离,为控制手指位置与触发器手指位置之间的扩展角。出于人体工程学目的,对距离d1、d2和d3以及扩展角和进行优化。例如,可以选择扩展角,使得:
d3<d2<d1。
扩展角代表远侧旋钮134上的控制手指位置186a与触发器手指位置188a之间的扩展度。控制手指位置186a与触发器手指位置188a之间的触及扩展度192a在三个触及扩展度192a、192b和192c中是最大的。远侧旋钮134的操作要求所有其他控件中的最大手指扩展度。此外,远侧旋钮134要求的启动力矢量(如向下)不同于第一突出旋钮132a或第二突出旋钮132b,其要求手指上的张紧程度更小。远侧旋钮134可构造为在触发器120处于完全关闭位置(如虚线所示)时禁用并锁定,这样也可缓解“最坏情形”的手指扩展角通常,可以选择远侧旋钮134与第一突出旋钮132a之间的间距196以最小化其间的拥挤,并最小化较长手指的触及难度。
扩展角代表第一突出旋钮132a处的控制手指位置186b与触发器手指位置188a之间的扩展度。控制手指位置186b与触发器手指位置188a之间的触及扩展度192b略大于控制手指位置186c与触发器手指位置188a之间的触及扩展度192c,并且触及扩展度192b触及第一突出旋钮132a比第二突出旋钮132b要求更大的手指扩展度。第一突出旋钮132a位于距第二突出旋钮132b距离足够远的位置以将任何可察觉的意外启动风险降至最低。此外,第一突出旋钮132a距远侧旋钮134距离足够远以最小化拥挤和较长手指所面临的任何触及难度。可以选择远侧旋钮134与第一突出旋钮132a之间的间距196,使得其最小化以将远侧旋钮134保持在控制手指位置186a的可达到的范围内,也可以使得其最大化以避免远侧旋钮134与第一突出旋钮132a之间拥挤。
扩展角代表第二突出旋钮132b处的控制手指位置186c与触发器手指位置188a之间的扩展度。控制手指位置186c与触发器手指位置188a之间的触及扩展度192c为中指与控制手指之间要求的最小扩展度,因此导致最小程度的手指张紧。第二突出旋钮132b的触及要求所有控件的最小手指扩展度,因此倾向于最易于启动。在完全打开位置,第二突出旋钮132b位于尽可能低的位置,并且不过于拥挤地靠着触发器120,从而避免“横穿”触发器手指。可以选择第二突出旋钮132b与触发器120a之间的间距194,以在触发器120处于完全关闭位置(如虚线所示)并且触发器手指位于位置188b(同样如虚线所示)时,最小化触及第一突出旋钮132a所要求的手指扩展角。
在一个实施例中,可以选择触发器枢轴190的位置以在触发器120从完全打开位置(如实线所示)枢转到完全关闭位置(如虚线所示)时控制和优化该触发器的运动弧,尤其是在其与跨度每一个末端的触发器手指位置相关的情况下。理想的运动弧为从闭合到开启略微向上移动,以与手指的自然开启运动相关。完全关闭位置可略微增大触及控件要求的手指扩展角,但在平衡触发器120的自然运动弧时是合格的。触发器120处于完全关闭位置时,触发器手指位置188b可略微增大触及多个控件要求的手指扩展角(即在中指与控制手指之间形成的角)。然而,可以将该增大程度最小化,使其处于触发器120的自然运动弧的合格的平衡内。
图26示出了柄部组件102的一个实施例的各种使用者接口之间的关系。在图示实施例中,柄部组件102可以限定为具有四个单独的轴。与细长内窥镜轴组件110的纵向轴线一致的纵向轴线“T”、鞍形表面轴“S”、使用者输入轴“U”、基准轴“L”、触发器120的枢转点190、细长触发器钩124的中心点191、鞍形表面130、控制手指位置186a、186b、186c,以及触发器手指位置188a、188b。触发器钩124限定由半径“r1”和中心点191限定的弓形部分。柄部组件102在完全闭合时在触发器120与固定的柄部122之间提供适当的间距。在启动第二突出旋钮132b的情况下开启触发器120时,第二突出旋钮132b(如MIN按钮)与细长触发器钩124顶部的间距/轮廓向外推动触发器手指。
在一个实施例中,启动使用者输入力“f1”为启动第一突出旋钮132a或第二突出旋钮132b所必需的力。在一个实施例中,力f1为大约400g+/-80g。启动使用者输入力f1为将使用者疲劳最小化(不太硬)和将意外启动的风险最小化(不太轻)之间的平衡力。启动使用者输入力f1是沿着启动第一突出旋钮132a的A-E矢量(从鞍形表面130到手指位置186b的矢量)和启动第二突出旋钮132b的A-F矢量(从鞍形表面130到手指位置186c的矢量)测量的。
在一个实施例中,将第一突出旋钮132a与第二突出旋钮132b之间的空间(如MI N/MAX按钮间距)定义为控制手指(如食指)“倚靠区域”193。使用者可在不启动电源的情况下使用控制手指在第一突出旋钮132a与第二突出旋钮132b之间的倚靠区域193上施加高达大约1.5磅的力。
在一个实施例中,可以通过相对于手柄组件102的内侧中央平面的任一侧面从0°至30°的定向压力矢量启动第一突出旋钮132a和第二突出旋钮132b。在手指较短的情况下腕部处于极端位置时,这样更容易触及第一突出旋钮132a和第二突出旋钮132b。
在一个实施例中,第二突出旋钮132b与位于细长触发器钩124限定的孔126内的最高手指之间的中心线大约为至少0.650″,以最大化舒适度,同时最小化“横穿”两根相邻手指的感觉。
在一个实施例中,细长触发器钩124的孔126内的手指余隙大约为至少0.650″以避免手指被夹住。
在一个实施例中,使用者输入轴(U)定义为直接位于触发器120上中指与无名指位置之间的轴U。使用者施加的触发器120闭合力定义为沿着U-X矢量(从近侧接触表面128到孔126内第一位置188a的矢量)测得的力f2。在一个实施例中,沿着U-X矢量测得的、将触发器120闭合到完全关闭位置所需的力可以大约小于6.14磅力,该力基于以下因素:
140.8磅力=5%纤巧女性的最大完全手部握持力;
40.8磅力×0.33=13.64磅力(舒适握持力降低67%);
13.64磅力×0.60=8.18磅力(不良姿势降低40%);以及
8.18磅力×0.75=6.14磅力(从完全握持情况移除食指时降低25%:相对手指力度:食指:25%,中指:35%,无名指:25%,小指:14%,来源:NCBI Pub Med,07/04)。
在一个实施例中,触发器120滥用闭合力定义为通过在细长触发器钩124的远端表面施加压力关闭触发器时生成的闭合力。在一个实施例中,触发器120可经受的合理滥用力为大约15.00磅力,该力基于实际关闭力的制造变化的上限为5磅力。预期使用者施加超过所需力的三倍的情况非常少。
在一个实施例中,触发器120开启力定义为沿着U-X矢量测得的、使用者完全开启触发器120所需的力f3。在一个实施例中,力f3为大约0.0+0.5/-1.5磅力。在一个实施例中,柄部组件102整合了一些弹簧辅助开启机构以克服系统中的摩擦,例如弹簧元件182(图14)。在一个实施例中,端部执行器组件112的夹钳应在要求的最小力下自行完全开启。连续施加多个闭合“咬力”时,“自动”完全开启可适当地增强易用性。最小化端部执行器组件112的夹钳开启所需的力可降低(例如)展开解剖期间丢失触觉反馈(外科医生需要尽可能地感觉所施加的组织张力,而不是弹力)的风险。
在一个实施例中,沿着使用者输入轴“U”测得的、触发器120的接触表面宽度可以为大约0.760″+/-0.200″,从而得到最大舒适度并避免压力点。
在一个实施例中,从细长触发器钩中心191到向前钩套环的末端测得的细长触发器钩124的长度可以为大约1.090″+/-0.080″,以有利于触发器120的向外开启行程的两手指接触。
在一个实施例中,从细长触发器钩中心191到触发器120的最低末端测得的触发器120的长度应为大约2.480″+/-0.080″,有利于闭合行程的三手指接触。
在一个实施例中,纵向重心可以位于邻近细长内窥镜轴组件110的原点大约0.700″+/-0.150″处由绝缘销的位置限定的点。装置的总重量定义为柄部组件与应力释放的近侧末端处截止的电缆118完全组装的重量。在一个实施例中,重心可以更靠近使用者的掌心,以用于最大化控制感和稳定性。
在一个实施例中,从A-L(从鞍形表面130到固定的柄部122的基部)垂直测得的固定的柄部122的手掌表面长度可以为大约2.900″+/-0.125″。可以通过在将尺寸最大化以实现更大的手部舒适度和稳定性以及将患者(通常在腿部抬起时发生)或台面对柄部组件102的潜在干涉最小化之间实现平衡来确定此距离。
在一个实施例中,手掌表面宽度不超过大约1.320″。可以通过在将闭合压力施加至触发器120时抵靠使用者手掌的舒适度、较小的手对固定的柄部122的背部表面区域周围到前部控件的触及以及在使用者手中的总体“贴合”之间实现平衡来确定此距离。固定的柄部122的侧面可以弯曲和仿形以自然贴合手掌并且为拇指和食指握持位置提供稳定性。
在一个实施例中,从U-X′测得的完全闭合握持跨度可以大于大约1.600″。从U-X测得的完全开启握持跨度可以小于最大大约2.300″的范围。
在一个实施例中,远侧旋钮134使用者接口可以包括多凹槽设计,每一个凹槽134a的手指接触半径为大约0.250″+/-0.050″。在一个实施例中,可以包覆成型凹槽134a以增大在远侧旋钮134上的握持能力。
在一个实施例中,旋转力定义为远侧旋钮134连接至柄部组件112时的摩擦力。旋转力应提供大约3.5-12.5英寸-盎司的扭矩阻力。可以通过平衡低端的适当阻力以克服由于缆线卷绕造成的轴倒转以及最小化高端的使用者输入力以最小化疲劳来确定该值。
在一个实施例中,触发器120表面的模制弹性部分120a的包覆成型柔量可以在接触承载触发器运动的任何点小于大约0.040″,以最大化触觉反馈。可以通过在重复触发器启动(尤其是手指向外伸展)期间提供增加的使用者舒适度以及不损失施加给组织的力的触觉反馈之间实现平衡来确定该值。
在一个实施例中,柄部组件102的整体构型可以基于手枪式握把设计,其优化的手掌近侧接触表面128(P)如本文实施例所述和所示。在一个实施例中,近侧接触表面128的优化可以包括由自然贴合手掌的器官曲线最佳限定的接触表面,而不是指定的握持角度。此理想曲线提供最大程度的握持舒适度、控制度和稳定性。通过使鞍形表面130直接位于稳定性尾部131的位置下方,在限定在拇指与食指之间的凹处或蹼上提供增加的控制感和稳定性。
从图26中也可以看出,接触表面128可以具有从参考点RP测得的半径RH。参考点RP可以位于距轴S为第一距离HD1并且距点A为第二距离HD2的位置。在一个实施例中,例如半径RH可以为大约2.99英寸,距离HD1可以为大约2.27英寸,距离HD2可以为大约2.20英寸。同样在各种实施例中,稳定性尾部131可以具有大约0.40英寸的第一半径部分RT,以及从第二参考点RP2测得的可以为大约2.91英寸的第二半径RT2。第二参考点RP2可以位于距点A为距离TL(其中TL可以为大约1.31英寸)并且距轴S为距离TL2(可以为大约2.33英寸)的位置。
在一个实施例中,接触使用者手掌或手指的柄部组件102的边缘具有大约0.040″的最小半径,除非材料的硬度测量值为70A或更小。
图27示出了超声外科手术器械100的一个实施例。在图示实施例中,示出超声换能器114的横截面视图位于柄部组件102的局部剖视图中。超声外科手术器械100的一个实施例包括连接到超声换能器114的超声信号发生器116,其包括手持式外壳198和超声启动的单个元件端部执行器组件或多重元件端部执行器组件112。如此前所述,端部执行器组件112包括超声启动刀片152和夹臂150。被称为“Langevin堆叠”的超声换能器114通常包括换能部分200、第一共振器部分或末端钟罩202和第二共振器部分或前端钟罩204,以及辅助元件。这些元件的总体构造为共振器。超声换能器114的长度优选地为系统波长二分之一的整数倍(nλ/2,其中“n”为任意正整数,如n=1,2,3......),下文将详细描述。声学组件206包括超声换能器114、鼻部锥208、速度变换器218和表面210。
可认识到,本文使用的术语“近侧”和“远侧”是以握持柄部组件102的柄部组件102的临床医师为参照的。因此,相对于柄部组件102的更为近侧的柄部组件102而言,端部执行器组件112是远侧。还可认识到,为了简洁明了,本文使用的例如“顶部”和“底部”等空间术语也是相对于握持柄部组件102的临床医师而言。然而,外科手术器械在许多取向和位置中使用,这些术语并非意图进行限制和绝对化。
在一个实施例中,末端钟罩202的远端连接到换能部分200的近端,前端钟罩204的近端连接到换能部分200的远端。前端钟罩204和末端钟罩202的长度由换能部分200的厚度、末端钟罩202和前端钟罩204所用材料的密度和弹性模量以及超声换能器114的共振频率等多个变量决定。前端钟罩204可以与速度变换器218一样,从其近端到其远端向内成锥形以放大超声振幅,也可以没有放大作用。合适的振动频率范围可以为约20Hz至120Hz,最合适的振动频率范围可以为约30Hz至100kHz。合适的工作振动频率可以为(例如)大约55.5kHz。
在一个实施例中,压电元件212可由(例如为)锆钛酸铅、间铌酸铅、钛酸铅、钛酸钡或其他压电陶瓷材料等任何合适的材料加工而成。正电极214、负电极216和压电元件212中的每一个都有穿过中心延伸的腔体。正电极214和负电极216分别电连接到导线220和222。导线220和222封闭在电缆118内,并且电连接到超声信号发生器116。
声学组件206的超声换能器114将来自超声信号发生器116的电信号转化为机械能,该机械能主要致使超声换能器114以及端部执行器组件112的刀片152部分出现以超声频率纵向振动运动的声学驻波。在另一个实施例中,超声换能器的振动运动可以在不同的方向起作用。例如,振动运动可以包括细长内窥镜轴组件110顶端更复杂运动的局部纵向分量。由Ethicon Endo-Surgery,Inc.(Cincinnati,Ohio)生产的GEN04型发生器是合适的发生器。当声学组件206通电时,声学组件206产生振动运动驻波。超声外科手术器械100设计在共振下操作,使得产生预定振幅的声学驻波图形。沿着声学组件206的任何点处的振动运动振幅取决于沿着声学组件206测量振动运动的位置。振动运动驻波的最小或零交点通常称为波节(即纵向运动最小的位置),驻波的局部最大绝对值或峰值通常称为波腹(即局部运动最大的位置)。波腹与距其最近的波节之间的距离为四分之一波长(λ/4)。
导线220和222从超声信号发生器116将电信号传输到正电极214和负电极216。由响应(例如)脚踏开关等启动器224的超声信号发生器116提供电信号为压电元件212供电,在声学组件206中产生声学驻波。电信号使压电元件212产生重复的小位移形式的扰动,在材料中导致大的交替压缩和张力。重复的小位移会使压电元件212以连续方式沿着电压梯度的轴线膨胀和收缩,从而产生超声能量的纵向波。通过细长内窥镜轴组件110的传输元件或超声传输波导部分164将超声能量穿过声学组件206传输至端部执行器组件112的刀片152部分。
在一个实施例中,为了使声学组件206传输能量到端部执行器组件112的刀片152部分,声学组件206的所有元件必须以声学方式耦合到刀片152。超声换能器换能器114的远端可使用(例如)双头螺栓226等螺纹连接与超声传输波导164的近端在表面210处以声学方式耦合。
在一个实施例中,声学组件206的元件经过优选地调音,使得任何组件的长度均为二分之一波长的整数倍(nλ/2),其中波长λ是声学组件206的预选或运行的纵向振动驱动频率fd的波长。也可构思声学组件206可整合任何合适排列的声波元件。
在一个实施例中,刀片152的长度基本上等同于二分之一系统波长的整数倍(nλ/2)。刀片152的远端可设置在波腹附近,以便提供远端的最大纵向偏移。当换能器组件通电时,刀片152的远端可成形为以(例如)55kHz的预定振动频率在(例如)大约10至500微米峰到峰的范围内移动,并且优选地在约30至150微米的范围内移动。
在一个实施例中,刀片152可连接到超声传输波导164。图中所示的刀片152和超声传输波导164使用适合超声能量传输的材料形成单个单元的构造。此类材料的实例包括Ti6Al4V(含有铝和钒的钛合金)、铝、不锈钢或其他合适的材料。刀片152也可以与超声传输波导164分开(并且由不同的组合物制成),以及通过(例如)双头螺栓、焊接、粘合剂、快速连接或其他合适的已知方法连接这两个部件。超声传输波导164的长度可以基本上等同于(例如)二分之一波长的整数倍(nλ/2)。超声传输波导164可以优选地由使用适合高效传播超声能量的材料(例如上述钛合金(即Ti6Al4V))或任何适合的铝合金或其他合金材料制造的实芯轴加工而成。
在一个实施例中,超声传输波导164包括位于近端的、纵向伸出的连接柱,通过(例如)双头螺栓226等螺纹连接而连接到超声传输波导164的表面210。超声传输波导164可以包括位于多个波节处的多个稳定硅胶环或适形的支承件168(图14)。硅胶环168使不可取的振动衰减并将超声能量与外护套166(图14)隔离,从而确保纵向的超声能量流以最大的效率流向刀片152的远端。
在各种实施例中,旋钮可以位于超声外科手术器械外壳的近端。近侧旋钮可以由拇指或食指轻易地触及,并且实质上可减少可能与位于远侧的旋钮相关的任何障碍或“延伸”问题。包括近侧旋钮的超声外科手术器械的若干实施例是结合图28-32进行描述的。
图28为包括近侧旋钮238的超声外科手术器械230的一个实施例的右侧视图。在图示实施例中,近侧旋钮238可以位于柄部组件102的近端。近侧旋钮238可以由拇指或食指轻易地触及,并且实质上可减少可能与位于远侧的旋钮相关的任何障碍或“延伸”问题。超声外科手术器械230可以用于多种外科手术,包括内窥镜手术或常规开放式外科手术。超声外科手术器械230包括柄部组件102、柄部组件232、近侧旋转组件234、开关组件236、细长内窥镜轴组件110和端部执行器组件112,其中端部执行器组件包括互相握持、切割和凝结管状血管和/或组织的元件。近侧旋转组件234包括以机械方式接合超声换能器114外壳的近侧旋钮238。超声外科手术器械230适于接纳以机械方式接合到细长内窥镜轴组件110和端部执行器组件112的部分的超声换能器114。超声换能器114通过电缆118电连接到发生器116。尽管大多数图形图示示出了用于结合内窥镜外科手术使用的多重端部执行器组件112,但超声器械可以用于更为常规的开放式外科手术。出于本文的目的,从内窥镜器械的角度来描述超声外科手术器械230;然而,可以构思,超声外科手术器械230的开放式形式也可以包括如本文所述相同或相似的操作组件和部件。
在一个实施例中,柄部组件232包括触发器246和上文所述的固定的柄部122。固定的柄部122与柄部组件102整体相连,触发器246相对于固定的柄部122可移动,下文关于超声外科手术器械230的操作将更为详细地对此进行说明。固定的柄部122和触发器246舒适地与使用者接合。使用者抵靠触发器246施加挤压力时,触发器246在方向121A朝固定的柄部122移动。使用者释放抵靠触发器246的挤压力时,弹簧元件182(图14)使触发器246在方向121B移动。触发器246包括细长触发器钩244,其限定细长触发器钩244与固定的柄部122之间的孔248。孔248的尺寸合适地设置为接纳从其中穿过的使用者的一根或多根手指。触发器246也可以包括接触部分(未示出),其可以在触发器246的部分上模制。包覆成型的接触部分为在方向121B向外控制触发器246提供更为舒适的接触表面。在一个实施例中,包覆成型的接触部分可以设置在细长触发器钩244的部分的上方。例如,包覆成型的接触部分可以设置在细长触发器钩244的内部的远端表面和顶部表面的上方,从而在使用者需要处得到缓冲。细长触发器钩244的近侧表面没有涂覆,而是保持裸基底(如聚碳酸酯),以使手指能够更轻易地滑入和滑出孔248。在其他实施例中,细长触发器钩244可以整合包括柔韧的、有弹性的、柔性聚合材料(例如VersaFlex,Inc.制造的聚脲弹性体)的包覆成型接触表面。细长触发器钩244可以整合包覆成型的接触表面部分,以便为使用者提供增加的舒适度或更加牢固的握持。使用者手指进入孔248时,细长触发器钩244内部的顶部上的包覆成型接触表面部分可缓解使用者手指上的边缘压力点。固定的柄部122包括远侧接触表面128和夹具锚或鞍形表面130,如上文结合图1-25的讨论。
在使用中,近侧旋钮238允许使用者同时旋转细长内窥镜轴组件110、控制端部执行器组件112夹持机构夹钳和启动摇臂开关132,这为有经验的使用者创造了装置的新用途。
图29为图28所示超声外科手术器械230的一个实施例的放大右透视图。在图示实施例中,近侧旋转组件234包括由柔韧的、有弹性的、柔性聚合材料(包括(例如)GLS Corporation制造的TPE合金)形成的旋钮238或环。在一个实施例中,近侧旋钮238可以位于柄部组件102的近侧部分。使用者可以用拇指或食指操作近侧旋钮238。使用拇指可解放食指,因而更加轻易和有效地触及位于柄部组件102的远端的拨动开关252。近侧旋钮238可以构造在多个元件中。一个元件可以包括由(例如)弹性材料、被称为的热塑性橡胶、其他热塑性硫化橡胶(TPV)或弹性体形成的弹性层包覆成型的硅化聚碳酸酯元件。弹性体层在近侧旋钮238的外边缘上为使用者提供牢固的握持,并且也突出穿过聚碳酸酯内环(未示出)以形成牢固地握持超声换能器114的外壳外部的“抓具”肋。因此,近侧旋钮238可牢固地握持超声换能器114。超声换能器114以机械方式牢固地接合到细长内窥镜轴组件110,使得旋转近侧旋钮238时可旋转整个细长内窥镜轴组件110。包括近侧旋钮238的近侧旋转组件234提供更平滑、更容易的旋转,以用于更好地控制和更方便地使用。近侧旋钮238可稳定位于超声换能器114前部的内部机构,以减小任何潜在的“碰撞声”。近侧旋钮238能够以机械方式接合超声换能器114的外壳,使得近侧旋钮238的旋转导致超声换能器114和细长内窥镜轴组件110在相同方向250旋转。近侧旋钮238包括多个凹槽240或肋。这些凹槽240可以由手指接合以使旋钮238旋转。近侧旋钮238可以包括由凹槽240形成的“扇形凹口”或凹槽,从而得到更加精确的旋转握持。在一个实施例中,近侧旋钮238可以包括六个凹槽。在其他实施例中,可以采用任何适合数量的凹槽。近侧旋钮238可以由在硬质塑性材料上包覆成型的较软聚合材料形成。
超声换能器114可以穿过近侧旋钮238插入,直到超声换能器114的远端由(例如)双头螺栓226(图27)螺纹连接到超声传输波导164中或扣到其上。在弹性体抓具肋与超声换能器114的外径之间插入期间,近侧旋钮238的弹性体抓具肋提供紧密的贴合性。然而,抓具握持并不足够紧密,因而在组件的组装过程中造成困难。超声换能器114螺纹连接到近侧开口156内的柄部102的母接头中时,随着末尾螺纹将超声换能器114向前旋入细长内窥镜轴组件110,近侧旋钮238可以连同超声换能器114自由旋转,并且也可以沿着超声换能器114的外表面沿着纵向轴线A自由纵向滑动。使用转矩扳手完全组装好超声换能器114后,近侧旋钮238仍然可以自由旋转,从而抓握超声换能器114并因此旋转整个细长内窥镜轴组件110。抓具肋将超声换能器114的外表面足够牢固地抓紧,以有利于旋转,即使在(例如)组件或使用者的手套可能润湿的外科手术条件下亦如此。
在一个实施例中,开关组件236可以实施为MIN/MAX摇臂开关或“拨动”开关252。在一个位置,MIN/MAX摇臂开关(或“拨动”开关)按钮可创造在最低程度(或基本上不)重新定位握把的情况下可轻易触及的位置以用于电源启动,从而使其适合维持控制并保持注意力集中到外科手术现场(如腹腔镜手术中的显示器)。开关组件236包括部分位于柄部组件102内的拨动开关252。开关组件236包括实施为摇臂开关252,其为具有位于柄部组件102内的中心枢轴的单个元件,以消除同时启动的可能性。摇臂开关252可以略微卷绕固定的柄部122的侧面,从而易于被不同长度的手指触及。拨动开关252连接到发生器116以控制超声换能器114的启动。拨动开关252包括启动超声换能器114的一个或多个电源设置开关以设置超声换能器114的一个或多个设置功率。在一个实施例中,拨动开关252包括第一电接触部分252a和第二电接触部分252b以在最小功率电平(如MIN)与最大功率电平(如MAX)之间设置超声换能器114的设置功率。拨动开关252的第一接触部分252a和第二接触部分252b可以由包括(例如)GLS Corporation制造的TPE合金的软质聚合材料包覆成型。包覆成型部分可以用于将拨动开关252接触部分252a、252b与柄部组件102的其余部分通过触觉识别或区别开来。接触部分252a、252b可以被构造为卷绕固定的柄部122至一定程度,以允许在不顺手位置启动或手指较短时具有较大的触及自由度。如此前所讨论,接触部分252a、252b中的一个可以包括让使用者能够区分第一接触部分252a和第二接触部分252b的纹理或触觉表面。第一接触部分252a或第二接触部分252b可以包括多个纹理肋252c,以允许使用者能够区分第一接触部分252a(MAX)和第二接触部分252b(MIN)。
拨动开关252可以由使用者的手操作。使用者可以轻易地触及位于任何点的第一电接触部分252a和第二电接触部分252b,同时也避免在任何时间意外或无意启动。拨动开关252可以由使用者的食指操作以启动超声组件114的电源和/或控制超声组件114的功率电平。食指可用于启动第一接触部分252a以将超声组件114接通到最大(MAX)功率电平。食指可用于启动第二接触部分252b以将超声组件114接通到最小(MIN)功率电平。第一接触部分252a或第二接触部分252b可以包括纹理以协助使用者在不观察的情况下通过触感进行区分。例如,在图示实施例中,第一接触部分252a包括多个纹理肋252c以便使用者能够区分第一接触部分252a(MAX)和第二接触部分252b(MIN)。可以在第一接触部分252a或第二接触部分252b上形成其他纹理或元件以便使用者能够区分两者。使用者无需观察第一接触部分252a或第二接触部分252b即可操作拨动开关252。这允许使用者在腹腔镜手术期间完全专注于显示器画面。使用者不必重新定位其握把便可操作拨动开关252,并且能够在开启端部执行器112的夹钳时轻松调节电源ON/OFF或MIN/MAX。
在一个实施例中,远侧旋转组件234可以绕纵向轴线(图13)在任意方向250不受限制地旋转。近侧旋转组件234以机械方式接合到超声换能器114的外壳,该超声换能器以机械方式接合到细长内窥镜轴组件110。近侧旋转组件234位于柄部组件102的近侧部分。近侧旋转组件234包括以机械方式接合超声换能器114的外壳的内部凸起,该超声换能器以机械方式接合到细长内窥镜轴组件110。旋钮238可以由食指接合以将细长内窥镜轴组件110在方向250旋转360°。
在一个实施例中,超声外科手术器械230可以被构造为具有人体工程学部件,以便使用者能够轻易触及和操作器械的多重功能和控件。因此,食指可以用于操作位于柄部组件102近端的远侧旋钮238。旋钮238以机械方式接合到超声换能器114的外壳,该超声换能器以机械方式接合到并且以声学方式耦合到超声传输波导164(图14)。因此,在外科手术中,食指可用于旋转旋钮238,以旋转超声传输波导164的轴,以将端部执行器组件112定位在适当的取向上。摇臂开关252的MIN/MAX电源按钮适当地位于器械230的固定的柄部122上,以使得它们可以由食指操作。因此,食指可用于旋转内窥镜部分110的轴来将端部执行器组件112的夹钳取向为所需位置并开启超声换能器114的功率电平。
图30-32示出了包括近侧旋转组件262的超声外科手术器械260的一个实施例。在在图示实施例中,包括近侧旋转组件262的超声外科手术器械260可以用于多种外科手术,包括内窥镜手术或常规开放式外科手术。在一个实施例中,超声外科手术器械260可以被构造为具有人体工程学部件,以便使用者能够轻易触及和操作器械的多重功能和控件。近侧旋转组件262可以位于柄部组件102的近端,并且可以由拇指或其他手指(如食指)轻易触及。这样实质上可减少可能与位于柄部组件102的远端的旋钮相关的任何障碍或“延伸”问题。此外,使用拇指可解放食指,例如使其更加轻易和有效地触及位于柄部组件102的远端的拨动开关132。
在一个实施例中,近侧旋转组件262包括环形近侧旋钮264。近侧旋钮264能够以机械方式或摩擦方式接合超声换能器114的外表面115。如此前所讨论,超声换能器114以机械方式接合到细长内窥镜轴组件110。因此,旋转旋钮264即可在相同方向250旋转超声换能器114和细长内窥镜轴组件110。近侧旋钮264包括在其外部113上形成的多个凹槽266(如肋或扇形凹口)。凹槽266可以由使用者的拇指或其他手指接合以在任意方向250绕纵向轴线“T”使近侧旋钮264旋转360°。近侧旋钮264的凹槽266还提供精确的旋转握持。在一个实施例中,旋钮264可以包括任何合适数量的凹槽226从而得到精确的旋转握持。近侧旋钮264还包括在其内部117上形成的多个径向突出268。径向突出268可以由柔韧的弹性聚合材料形成或涂覆有柔韧的弹性聚合材料,从而以摩擦方式牢固地接合超声换能器114的外表面115。径向突出268的尺寸设置为在超声换能器114的外表面115与近侧旋钮264之间形成紧密或牢固的贴合。超声换能器114由表面210和双头螺栓266(图27)以机械方式牢固地接合到细长内窥镜轴组件110的超声传输波导164部分。因此,随着牢固握持的近侧旋钮264在方向250旋转,超声换能器114和整个细长内窥镜轴组件110也在该方向旋转。近侧旋钮264使用拇指或其他手指使超声换能器114和细长内窥镜轴组件110平滑、容易地旋转,从而为外科医生提供增加的控制度。超声换能器114包括具有周向脊274的远端边缘部分272以接合在近侧开口156的内壁中形成的凹槽(未示出)。
如此前所讨论,在一个实施例中,近侧旋钮264以机械方式或摩擦方式牢固地接合到超声换能器114的外部外壳,该超声换能器以机械方式接合到并且以声学方式耦合到超声传输波导164(图14)。例如,在外科手术期间,拇指或食指可以用于控制超声传输波导164轴的旋转,以将端部执行器组件112的夹钳定位在合适的取向上。中指和/或其他较短手指可以用于挤压触发器120和抓握夹钳内的组织。一旦夹钳位于所需位置并且夹钳夹住组织,食指就可以用于启动拨动开关132以调整超声换能器114的功率电平和处理组织。一旦已经处理了组织,使用者就可以使用中指和/或其他较短手指释放触发器120并抵靠细长触发器钩沿远侧方向向外推动,从而打开端部执行器组件112的夹钳。使用者不必调整柄部组件102上的握把即可执行此基本过程。
在一个实施例中,近侧旋钮264可以由柔韧的、有弹性的、柔性聚合材料(包括(例如)GLS Corporation制造的TPE合金)形成。柔韧的、有弹性的、柔性聚合材料为使用者在近侧旋钮264的外部上提供牢固和舒适的握持。
近侧旋钮264可以作为与超声外科手术器械260包装在一起但不附接到其上的附件形式单独提供。近侧旋钮264可以为由基本上柔韧的、有弹性的、柔性聚合材料形成的环状物或环形的单个元件。近侧旋钮264可以插在超声换能器114的外表面115上,如由EthiconEndo-Surgery制造的手持件HP054或HPBLUE。在近侧旋钮264的内部117上形成的径向突出268或“抓具肋”牢固地接合超声换能器114外表面115直径。径向突出268可以由与近侧旋钮相同的柔韧的、有弹性的、柔性聚合材料形成,并且限定相对于超声换能器114的外表面115直径较小的直径以形成摩擦过盈配合。然而,径向突出268并不会过紧地接合超声换能器114的外表面115直径,以免组件组装困难。
一旦近侧旋钮264位于超声换能器114的外表面115上,换能器114就通过器械柄部组件102的近侧开口156插入。表面210通过双头螺栓226(图27)附接到超声传输波导164。在其他实施例中,超声换能器114的远端可以扣到超声传输波导164的近端上。一旦超声换能器114的远端位于器械柄部组件102的近侧开口156中,随着双头螺栓226的末尾螺纹将超声换能器114沿朝向细长内窥镜轴组件110的方向向前拉动,近侧旋钮264就可以连同超声换能器114自由旋转,并且也可以沿着超声换能器114的外表面沿着纵向轴线T自由纵向滑动。使用转矩扳手完全组装好超声换能器114后,近侧旋钮264仍然可以自由扭转,从而握持超声换能器114并因此旋转整个细长内窥镜轴组件110。用足够的力将径向突出268以摩擦方式紧固超声换能器114的外表面,以有利于细长内窥镜轴组件110的旋转,即使在组件或外科医生的手套可能润湿的外科手术条件下亦如此。使用之后,近侧旋钮264可以从超声换能器114移除,也可以如下所述丢弃或消毒。
图33为用于包括近侧旋转组件和远侧旋转组件两者的超声外科手术器械的柄部组件280的一个实施例的左侧视图。在一个实施例中,柄部组件280包括多个可以在多个手部位置触及并且适合多种手部大小的旋转控件。在一个实施例中,柄部组件280包括具有如此前所述的远侧旋转控制旋钮134和近侧旋转控制旋钮264的双旋转控件。在一个实施例中,柄部组件280包括具有如此前所述的远侧旋钮134的远侧旋转组件106。此外,柄部组件280包括具有如此前所述的近侧旋钮264的近侧旋转组件262。
图34为柄部组件280的一个实施例的局部放大左透视图。如图34所示,在一个实施例中,近侧旋钮264呈环形并且包括外部113和内部117。其外表面276上形成有多个凹槽266。近侧旋钮264的内表面270包括多个径向突出268,从而能以摩擦方式接合超声换能器114手持式组件的外轮廓。如此前所讨论,近侧旋钮264可以由(例如)柔韧的、有弹性的、柔性聚合物材料形成。
参照图33和图34两者,双旋转控件(例如近侧旋转组件262和远侧旋转组件106)的组合可带来若干益处。双旋转控件由于利用了拇指和/或其他手指的自然移动,因此使柄部组件280可更好地适应手小的使用者并且减轻了疲劳程度。如果手小的使用者难以触及远端控制旋钮134的指尖旋转控件或者手处于不顺手位置,近侧旋钮264可为使用者提供另一种选择,即使用近侧旋钮264通过拇指来控制细长内窥镜轴组件110的旋转。
可以组合使用近侧旋钮264和远侧旋钮134来反向旋转细长内窥镜轴组件110以缓解应力和疲劳,并且防止在使用期间只朝一个方向旋转时电缆118(图1、图27、图28、图30)卷绕在手持件上。右手使用者(例如)可以使用食指来顺时针旋转远侧旋钮134,而使用拇指来逆时针旋转近侧旋钮264,以缓解手指疲劳并且防止电缆118缠结在一起。因此,由于使用者可以在顺时针和逆时针旋转方法之间轻松切换,电缆118变得较少缠结在一起。
近侧旋转组件262和远侧旋转组件106相组合的其他益处包括同时使用多重功能和轻松采用多个手部位置。近侧旋钮264使得能够使用拇指旋转控制端部执行器组件112。对于手小的使用者来说,这样可能更为舒适并且可以更精细地控制旋转。如此前所讨论,在使用中,近侧旋钮264允许使用者同时旋转细长内窥镜轴组件110、控制端部执行器组件112的夹紧机构的夹钳和启动摇臂开关132,这为有经验的使用者创造了装置的新用途。通过提供远端旋转控件和近端旋转控件的组合,使用者可根据手部位置(如中性位置、反握位置、正握位置、不顺手位置)选择最适合的旋转控件。由于在实现控制旋钮旋转的朝下运动过程中其他手指和拇指是以自然移动的方式移动的,因此双旋转还减轻了疲劳程度。例如,中指可以向远侧旋钮134施加朝下的力,从而顺时针旋转细长内窥镜轴组件110。逆时针旋转远侧旋钮134则需要中指朝上运动,这可能不顺手并且略微更容易疲劳。拇指可以向近侧旋钮264施加朝下的力,从而逆时针旋转细长内窥镜轴组件110。因此,逆时针旋转细长内窥镜轴组件110需要更顺手并且更不易疲劳的拇指朝下运动。双旋转控件构型让使用者可以选择其他手指或拇指来旋转细长内窥镜轴组件110,这可导致在一个肌群上产生更少的复合疲劳。在任一种情况下,使用者都可以选择最适合其身体素质和体型的控件构型。
图35示出了超声外科手术器械的柄部组件281的一个实施例的局部剖视图。现在参考图35和图10-12以及图14,在一个实施例中,触发器278启动托架170,其通过多个联接件构件和托架170以机械方式接合到连接元件160(图14)。连接元件160安放在托架170中并且用所提供的销162(图14)穿过托架170中的开口171锁定在适当位置。细长内窥镜轴组件110通过连接元件160连接到托架170。连接元件160与位于外管状护套142近端的毂163以机械方式接合在一起。例如,外管状护套142的毂163通过销162保留在托架170中。往复式管状启动元件144的近端以机械方式接合到外管状护套142。一旦锁定在适当位置,托架170、连接元件160就在开口296内沿着位于纵向轴线T上的146A、146B方向往复运动,以使使细长内窥镜轴组件110在相同方向运动。运动是对触发器278的响应。因此,当触发器在方向121A、方向121B移动时,托架170、连接元件160和细长内窥镜轴组件110会在对应方向146A、方向146B移动。如此,当触发器278在方向121A受到挤压时,往复式管状启动元件144将在方向146A移动以在方向148A闭合端部执行器组件112的夹钳元件,如图10-12所示。当挤压力被释放时,弹簧元件182将在方向121B使活动的触发器复位。因此,托架170和往复式管状启动元件144在方向146B移动时将在方向148B打开端部执行器组件112的夹钳,如图10-12所示。
在图示实施例中,毂133位于柄部组件102的第一部分102a和第二部分102b内。周边唇缘344形成于圆柱形套管部分135上并且接纳在柄部组件102的远端形成的周边凹槽346中。周边唇缘344和周边凹槽346的尺寸设计为使得圆柱形套管部分135可以在周边凹槽346内自由旋转。当柄部组件102的第一部分102a和第二部分102b配合后,毂133可在周边凹槽346内自由旋转。毂133的尺寸设计和构造为可接纳远侧旋钮134。
在一个实施例中,触发器278在活动的第一枢转点288处以机械方式接合到第一联接件元件282和第二联接件元件284。活动的枢转点288被限定在第一狭槽294内并在该狭槽内运动。在一端,第一联接件元件282和第二联接件元件284在第一枢转点288可枢转。在第一联接件元件282的另一端,第一联接件元件连接到第二枢转点290并且可绕其旋转。在第二联接件元件284的另一端,第二联接件元件284连接到第三枢转点292并且可绕其旋转。在一端,第三联接件元件286在第三枢转点292连接到第二联接件元件284。在另一端,第三联接件元件286连接到第四枢转点300,该第四枢转点被限定在第二狭槽302内并可在该狭槽内运动。托架170在第四枢转点300连接到第三联接件元件286。托架170连接到连接元件160并且成为往复式托架组件173的一部分。因此,当在方向121A挤压触发器120时,第一枢转点288将在第一狭槽294内朝下运动,从而向下地拉动第二联接件元件284和第三联接件元件286。向下地拉动第三联接件元件286时,托架170将在沿着纵向轴线T的方向146A受力,从而在方向148A闭合端部执行器组件112的夹钳。释放活动的触发器120后,弹簧元件182将对触发器278施力使其在方向121B移动,继而对托架施力以使其在沿着纵向轴线T的方向146B移动,从而在方向148B打开端部执行器组件112的夹钳。
图36是位于柄部组件281外壳部分内的拨动开关132和托架组件173的一个实施例的局部放大视图。开关组件108包括拨动开关132,拨动开关被实施为具有在柄部组件102内的中心枢轴304的单个元件,以消除同时启动的可能性。启动第一突出旋钮132a和第二突出旋钮132b时,拨动开关132将绕中心枢轴304旋转。电气元件172b将根据第一突出旋钮132a或第二突出旋钮132b的启动情况使超声换能器114通电。
图37-44示出了包括近侧旋转组件和远侧旋转组件的超声外科手术器械的柄部组件310的一个实施例。在图示实施例中,柄部组件310包括多个可以在多个手部位置触及并且适合多种手部大小的旋转控件。在一个实施例中,柄部组件310包括由第一部分314a(未示出)和第二部分314b形成的外壳314。柄部组件310包括近侧旋转组件312和远侧旋转组件106,如此前所述。近侧旋转组件312包括近侧旋钮334,远侧旋转组件106包括远侧旋钮134。
在一个实施例中,柄部组件310包括远侧旋转组件106,该远侧旋转组件包括具有如此前所述的毂133和凹槽134b的远侧旋钮134。此外,柄部组件310包括近侧旋转组件312。近侧旋转组件312包括附接到圆柱形毂335和在其外部上形成的多个凹槽336的近侧旋钮334。圆柱形毂335包括适于且被构造为与在外壳314中形成的对应周边凹槽328接合的周边唇缘332。周边唇缘332和对应的周边凹槽328的尺寸设计为使圆柱形毂335能够在周边凹槽328内自由旋转。圆柱形毂335包括多个围绕其周边形成的狭槽330。近侧旋钮334包括多个围绕其周边形成、与狭槽330对应的径向突出338。近侧旋钮334可以由柔韧的、有弹性的、柔性材料形成。多个径向突出338的一部分穿过狭槽330径向突出,从而以摩擦方式牢固地接合超声换能器114的外表面。
在一个实施例中,柄部组件310包括触发器322和固定的柄部316。固定的柄部316与柄部外壳314整体相连,并且如此前图1-9关于超声外科手术器械100的操作的详细说明,触发器322可以相对于固定的柄部316移动。固定的柄部316和触发器322为使用者提供了舒适的接触。向触发器322施加挤压力时,触发器322将在方向121A朝固定的柄部316移动。当使用者释放施加在触发器322上的挤压力时,弹簧元件182(图14)将使触发器322在方向121B移动并返回初始状态。
在一个实施例中,触发器322包括细长触发器钩324部分,其可限定细长触发器钩279与固定的柄部122之间的孔126。孔126的大小设置为适合接纳从其中穿过的一根或多根手指。
在一个实施例中,触发器322也可以包括在触发器322的基底上模制的接触部分322a。包覆成型的部分322a为在方向121B向外控制触发器322提供更为舒适的接触表面。在一个实施例中,包覆成型部分322a可以设置在细长触发器钩324的部分的上方。例如,在图示实施例中,包覆成型部分322a的接触表面设置在细长触发器钩324的内部部分的远端表面和顶部表面的上方,从而在使用者需要处得到缓冲。细长触发器钩324的近侧表面没有涂覆,而是保持裸基底(如聚碳酸酯),以使手指能够更轻易地滑入和滑出孔126。
在其他实施例中,细长触发器钩324可整合由柔韧的、有弹性的、柔性聚合物材料(包括(例如)GLS公司制造的TPE合金)形成的包覆成型组件。细长触发器钩324可以整合包覆成型部分322a,以便为使用者提供增加的舒适度或更加牢固的握持。在细长触发器钩324内部的顶部上形成的包覆成型部分322可缓解在手指进入孔126时,于手指上形成的边缘压力点。触发器钩324的顶部可以包括凹形区325,以便为第二突出旋钮132b(未示出)留出额外的间隙。
在一个实施例中,固定的柄部322包括近侧接触表面317和夹具锚或鞍形表面318。近侧接触表面317是常规的手枪式握把,没有被接纳到使用者手掌中的环或孔。近侧接触表面317的轮廓曲线具有适应或接纳手掌的轮廓。为了在使用超声波器械时提供舒适度和控制度,近侧接触表面317的轮廓被优化为贴合掌心凹处和拇指根部的自然解剖学轮廓。在一个实施例中,鞍形表面318提供了有助于稳定地控制柄部组件310的夹具锚。鞍形表面318的位置确定了其他手指和拇指从固定的柄部316的近侧接触表面317触及近侧旋钮334、远侧旋钮134、细长触发器钩324和电源启动拨动开关的运动范围。
当柄部为柄部组件310提供额外的控制时,可以接触位于拇指与食指之间的手部的稳定性尾部320使该操作的稳定性得以增强。稳定性尾部320提供了延伸的返回区,从而使超声外科手术器械的近侧重量落在使用者手的顶部。这为柄部组件310的鞍形表面318提供了更好的稳定感、舒适度和控制度。
图45-52示出了图37-44中所示近侧旋转组件312的一个实施例。在图示实施例中,近侧旋转组件312包括插在圆柱形毂335上的近侧旋钮334。近侧旋钮334包括多个径向突出338,形成于圆柱形毂335的近侧末端上的对应狭槽330会接纳径向突出338。近侧旋钮334限定了开口348来接纳超声换能器114的远端。径向突出338由软质聚合材料形成,并且限定了尺寸比超声换能器114的外部直径相对较小的直径,从而在超声换能器114的远端形成摩擦过盈配合。由聚合物形成的径向突出338沿径向伸出进入开口348中,以形成能牢牢地抓住超声换能器114的外壳的“抓具”肋。因此,近侧旋钮334牢牢地抓住超声换能器114。
圆柱形毂335的远端包括周边唇缘332和周边支承表面340。例如,如图38和图40所示,周边唇缘与在外壳314中形成的凹槽328接合,周边支承表面340则与外壳314接合。这样,圆柱形毂335便以机械方式保留在外壳314的两个外壳部分314a(未示出)和314b内,如图37-44所示。圆柱形毂335的周边唇缘332位于或“被捕获”在第一外壳部分314a与第二外壳部分314b之间,并且可在凹槽328内适当地自由旋转。周边支承表面340倚靠着外壳314的内部,以协助正确的旋转。这样,圆柱形毂335便可在外壳314内适当地自由旋转。使用者利用其手指或拇指接合在近侧旋钮334上形成的凹槽336,以旋转外壳314内的圆柱形毂335。
在一个实施例中,圆柱形毂335可以由(例如)聚碳酸酯的耐用塑料形成。在一个实施例中,圆柱形毂335可以由硅化聚碳酸酯材料形成。在一个实施例中,近侧旋钮334可以由柔韧的、有弹性的、柔性聚合物材料(包括(例如)GLS公司制造的TPE合金)形成。例如,近侧旋钮334可以由弹性材料、被称为的热塑性橡胶、其他热塑性硫化橡胶(TPV)或弹性体形成。然而,实施例并不仅限于此。
图53-57示出了图37-44所示远侧旋转组件106的一个实施例。在图示实施例中,远侧旋转组件106是由毂133(包括形成于其上的凹槽型旋钮134)形成的。毂133包括圆柱形套管部分135,该圆柱形套管部分接纳在远侧外壳部分(例如,第一外壳部分102a和第二外壳部分102b以及第一外壳部分314a和第二外壳部分314b)内。圆柱形套管部分135上会形成一对开口342,用于接纳销162以保持外管状护套142的毂部分163(图14)。周边唇缘344形成于圆柱形套管部分135上,并且接纳在柄部组件102的远端中形成的对应凹槽346中。周边唇缘344和周边凹槽346的尺寸设置为当柄部组件102的第一部分102a和第二部分102b配合时,圆柱形套管部分135可在周边凹槽346内自由旋转。
毂133位于或可旋转地“被捕获”在左侧外壳部分102a与右侧外壳部分102b之间,并且可在凹槽346内适当地自由旋转。凹槽型旋钮134采用人们熟知的包覆成型技术或其他技术形成于毂133的上方。凹槽型旋钮134也可以机械方式或摩擦方式与毂133接合。凹槽由突出的脊或肋134b限定,凹形区134b则形成于其间。毂133可以由(例如)聚碳酸酯的耐用塑料形成。在一个实施例中,毂133可以由硅化聚碳酸酯材料形成。例如,凹槽型旋钮134可以由具有弹性的柔韧聚合材料形成,如Santoprene或Versaflex。该实施例不局限于这种情况。
现在转到图58-69,得到在尺寸、形状和控件接口的位置方面对每个人均“理想”的柄部设计是长久以来所面临的挑战。从5%的纤巧女性外科医生到95%的魁梧的男性外科医生,人体测量视差很大,这对设计适合处于范围极端的使用者的柄部历来都是人体工程学挑战。对于提供多种不同的柄部尺寸,尽管已考虑了一段时间,但医院团体通常会维持较少的库存,因此仍然存在个别医院没有适合个别人士的某些尺寸的柄部的风险。因此,各种实施例为多种器械提供了柄部设计,使其在舒适度和控制度方面能为各种手部大小提供更符合人体工程学的接触。
图58为适于接纳柄部适配器的超声外科手术器械的柄部组件102的一个实施例的右侧透视图。柄部组件102包括触发器组件104、远侧旋转组件106和开关组件108。柄部组件102包括触发器120和固定的柄部122。固定的柄部122与柄部组件102整体相连,触发器120可以相对于固定的柄部122移动,下文关于超声外科手术器械100的操作将对此进行更详细的说明。固定的柄部122和触发器120可为使用者提供舒适的接触。固定的柄部122包括近侧接触表面128和握持锚状结构或鞍形表面130。稳定性尾部131可以接触位于拇指与食指之间的手部,并且为柄部组件102增加了稳定性。触发器120包括细长触发器钩124,该细长触发器钩124限定了位于细长触发器钩124与固定的柄部122之间的孔126。柄部组件102适于按照下文所述方式接纳柄部适配器。
图59为柄部组件102的一个实施例和柄部适配器400的一个实施例的右侧透视图。柄部适配器400包括限定用于接纳固定的柄部122的开口402的主体、近侧接触表面128、鞍形表面130和稳定性尾部131。开口402的内部限定了形状与近侧接触表面128、鞍形表面130和稳定性尾部131形状相反的轮廓,使得适配器可紧密地倚靠近侧接触表面128、鞍形表面130和稳定性尾部131贴合。开口402的外部轮廓限定了大致类似于最初形成于固定的柄部122上的近侧接触表面128、鞍形表面130和稳定性尾部131的新固定的柄部122′、近侧接触表面128′、鞍形表面130′和稳定性尾部131′部分。柄部适配器400的厚度或宽度以符合人体工程学的方式适合使用者手的大小。柄部适配器400可以形成为单件式元件,并且可以封装成结合大小可被设计为适合平均到较小手型的超声外科手术器械一起使用。柄部适配器400可方便地以可拆卸方式附接到超声外科手术器械100的柄部组件102,以扩展或放大握把的尺寸,从而适应较大的手。器械包装上以及柄部适配器400上可能提供有显眼的图片,以说明柄部适配器400的预定用途。柄部适配器400的整体外观使其功能可轻易为人所理解。
图60为柄部组件102的一个实施例的右侧透视图,其包括附接到其上的柄部适配器400。在一个实施例中,柄部适配器400可以形成为压力配合元件,它“像手套一样”贴合到固定的柄部122的主要握持部分上。在使用期间,柄部适配器400以摩擦方式固定就位。柄部适配器400可方便地从柄部组件102上移除。柄部适配器400可以由多种材料形成,包括多种具有不同硬度的弹性体、刚性聚合物和柔性聚合物等。在一个实施例中,适配器的表面区域可以包括位于柄部适配器400的几何轮廓上方的各种纹理和握把细节设计。在另一个实施例中,柄部适配器400可以具有嵌入作为主柄部的一部分的可变大小结构,其中,锁定/释放控件使柄部适配器400的近侧部分可延展或压缩,从而允许进行几乎无限制的调整以适合具体手部大小。
图61-69示出了柄部适配器410的一个实施例,其包括适于附接到超声外科手术器械的柄部组件的卡扣部件。柄部适配器410限定了适于和能够接纳外科手术器械柄部组件的固定的柄部的开口412。柄部适配器410限定了柄部组件的固定的柄部122′、近侧接触表面128′、鞍形表面130′和稳定性尾部131′部分,其中柄部组件更适当地以符合人体工程学的方式适应使用者的手。柄部适配器410可以形成为单件式元件,并且可以封装成结合大小可被设计为适合平均到较小手的超声外科手术器械一起使用。柄部适配器410可方便地以可拆卸方式附接到超声外科手术器械100的柄部组件102(图58-60),以扩展或放大握把的尺寸,从而适合较大的手。包装上以及柄部适配器410上可能提供有显眼的图片,以说明柄部适配器410的预定用途。柄部适配器410的整体外观使其功能可轻易为人所理解。
在一个实施例中,柄部适配器410可以形成为压力配合元件,它“像手套一样”贴合到固定的柄部的主要握持部分上。柄部适配器410的内部包括可接纳在柄部组件102(图58-60)的固定的柄部122部分上限定的对应开口(未示出)中的卡扣部件404。卡扣部件404以机械方式将柄部适配器410附接到固定的柄部122,并且在使用期间将柄部适配器410固定到位。柄部适配器410方便地以可拆卸方式附接到柄部组件102的固定的柄部122。柄部适配器410可以由多种材料形成,包括多种具有不同硬度的弹性体、刚性聚合物和柔性聚合物等。在一个实施例中,适配器的表面区域可以包括位于柄部适配器410的几何轮廓上方的各种纹理和握把细节设计。在另一个实施例中,柄部适配器410可以具有嵌入作为主柄部的一部分的可变大小结构,其中,锁定/释放控件使柄部适配器410的近侧部分可延展或压缩,从而允许进行几乎无限制的调整以适合具体手大小。
现在转到图70-87,超声外科手术器械100(尤其是腹腔镜手术超声外科手术器械100)的多重功能能力可能给使用者舒适地触及和操作该器械的多重功能和控件带来了某些人体工程学方面的挑战。这些挑战包括舒适地启动端部执行器组件112的夹紧机构的夹钳以及启动例如拨动开关132的手控按钮的能力。例如,使用者必须能够在方向148B(图3和图11)上控制端部执行器组件112的开启运动以有利于展开解剖。使用腹腔镜手术器械展开解剖需要反应表面以允许使用者能够在多个方向操作器械。使用拇指的向外运动对抗“锚定的”手指,从而提供充分的向外运动来完成此任务。先前所述的超声外科手术器械包括具有固定的柄部的柄部组件,该固定的柄部与柄部组件整体地形成或可拆卸地附接到其上。手枪式握把整合了触发器,在将握把保持在柄托的同时,可以使用食指和中指向外推动触发器。然而,这种向外运动动作可能在展开或精细解剖手术期间造成疲劳和手部紧张。尽管如此,这种向外运动仍是展开或精细解剖腹腔镜手术期间的必需操作。手枪式握把柄部就易于解剖来说可能不是最理想的,但因这种握把风格所具有的舒适性、方便性和稳定性使其成为许多外科医生的首选。对于解剖,许多外科医生更喜欢剪刀状套环或环型握把。因此,下面描述的各种实施例均提供了包括适于和被构造为具有剪刀状套环或环型握把的柄部组件的超声外科手术器械。剪刀状套环或环型握把可以与柄部组件整体地形成,也可以可拆卸地附接套环适配器的形式实施。
图70示出了超声外科手术器械的柄部组件102的一个实施例,该超声外科手术器械包括套环柄部适配器组件418。套环柄部适配器组件418包括套环柄部适配器420和附接到其上的有弹性的、柔韧的和/或柔性元件428。套环柄部适配器420将柄部组件102的固定的柄部122部分从常规的手枪式握把改变或转换为具有一对由孔422限定的套环的剪刀状套环或环型握把。例如,在展开或精细解剖腹腔镜手术期间,套环柄部适配器420有利于使用更可控的操作来向外运动柄部组件102。套环柄部适配器420适于且能够以可拆卸方式附接到柄部组件102的固定的柄部122部分。套环柄部适配器420包括一个或多个卡扣部件424(图71)以及一个或多个整体地形成于套环柄部适配器420的内表面425(图71)上的柱426(图71、图77、图79)。一个或多个卡扣部件424(图71-73、图77-80)以可拆卸方式将套环柄部适配器420接合到柄部组件102的固定的柄部122上。一个或多个柱426将套环柄部适配器420与固定的柄部122对齐。在一个实施例中,细长触发器钩124可包括多个由柔韧的、有弹性的、柔性聚合物材料(包括(例如)GLS公司制造的TPE合金)形成的结节127。
孔422由两个弯曲元件430a、430b(430b示于图71-79中)和在基座部分436处以及上鞍形表面438处接合的近端接触元件432所限定。两个弯曲元件430a、430b和近端接触元件432还限定了稳定性尾部434。孔422适于接纳从其中穿过的使用者的拇指,使得使用者可以更轻易和更舒适地操作柄部组件102或施加回缩力。使用者可以将拇指插入穿过孔422,并且接合固定的柄部122的近侧接触表面128和鞍形表面130,其中固定的柄部122保持露出以接合手部。套环柄部适配器420还可被用作适合手较大的、希望通过常规手枪式握把来使用柄部组件102的使用者的适配器。近端接触元件432、上鞍形表面438和稳定性尾部434提供了较大的范围来适应较大的手部,以更舒适地触及例如触发器120和开关组件108的控件。套环柄部适配器420还限定了下鞍形表面442来适应拇指下根部。
图71-80示出了套环柄部组件418的一个实施例。如图所示,套环柄部组件418包括连接到柔性元件428的套环柄部适配器420。套环柄部适配器420包括两个相对于轴435半径为“r”的弯曲元件430a、430b。两个弯曲元件430a、430b连接到近端接触元件432以限定孔422、上鞍形表面438、稳定性尾部434和下鞍形表面442。从功能上来说,孔422让使用者可利用拇指来辅助操作柄部组件102。上鞍形表面438和稳定性尾部434具有的功能与结合图25和图26的上述功能相同。柱426可以形成于套环柄部适配器420的基座部分436附近,而卡入形成于固定的柄部122侧面上的对应凹口或开口(未示出)的两个卡扣部件424可以形成于柄部组件102的鞍形表面130区域附近。这样便可在需要时,快速牢固地以可拆卸的方式安装可轻易移除的连接。柔性元件428包括多个肋440,从而得到弹性并且减小对拇指侧面产生的压力。柔性元件428还包括下鞍形表面442a来接合套环柄部适配器420的下鞍形表面442。套环柄部适配器420还提供了接触表面444来接合使用者的拇指。在一个实施例中,有弹性的、柔韧的柔性元件428可以连接或模制到套环柄部适配器420的近端接触元件432。套环柄部适配器420可以形成为具有柔性元件428的单个元件,也可以形成为独立的元件。套环柄部适配器420可以由(例如)聚碳酸酯的耐用塑料形成,柔性元件428可以由柔软的、柔韧的、有弹性的柔性聚合物材料(包括(例如)GLS公司制造的TPE合金)形成。柔性元件428可以在套环柄部适配器420上形成,也可以单独形成然后再附接到其上。
图81-82示出了套环柄部适配器420的一个实施例的左侧透视图和前侧透视图。图82示出了用于接纳柔性元件428的近端接触元件432的内部主体部分432a。
图83-87示出了图71-80所示套环柄部组件418的柔性元件428部分的一个实施例。柔性元件428可以由柔韧的、有弹性的柔性聚合物材料(包括(例如)GLS公司制造的TPE合金)形成。柔性元件428由单个元件形成,该单个元件包括接触表面444、多个肋440以及适于接合图81-82所示套环柄部适配器420的下鞍形部分442的鞍形接触表面442b。可以用使用者的拇指或手接合鞍形表面442a。柔性元件428还包括用于接纳近端接触元件432的内部主体部分432a的槽446。如图所示,槽446扩大为较大的槽448以适应套环柄部适配器420的下鞍形表面442。
现在转到图88-90,可使用多个因素来评估医疗器械的具体设计的人体工程学可行性。除舒适度之外,一个客观因素是以轻易完成外科手术任务所需的合适控制度来控制柄部组件102工作端的能力。要达到此控制的程度,首先源自柄部组件102在使用者手中的固有稳定性,其次源自操做具体器械控件所需的更精细动作的容易程度。设计工作包括在整体手持稳定性能力与有利于适当地触及精细控件之间实现平衡。
在各种实施例中,柄部组件102可以通过调整多种手枪式握把来进行稳定。手枪式握把的各种实施例提供多个手上的固定点:
(1)倚靠在拇指与食指之间关节蹼上的挤压力;
(2)拇指与食指之间的握持力;以及
(3)启动触发器120时手指与手掌之间的握持力。
在位于柄部组件102的远端上的多个控件之间存在可以用作固定点的最佳位置。这些位置包括位于远侧旋钮134、拨动开关132、触发器120以及鞍形表面130之间的位置,其中鞍形表面倚靠在手关节的拇指/食指蹼处。一些实施例在固定的柄部122部分的宽度上进行变化以适应多种手部大小,包括对位于鞍形表面130与前部控件之间的基本距离的变化。其他实施例在固定的柄部122的长度上进行变化,以使固定的柄部122的末端位于靠着手掌的位置。再者,其他实施例在固定的柄部122的角度上进行变化。
图88示出了柄部组件350的一个实施例,其包括在固定的柄部122的后部或近侧位置处形成的弯曲稳定性突出352(如凸耳)。弯曲稳定性突出352在固定的柄部122与手掌长度之间提供紧密的接触表面,以稳定柄部组件350。一个固定点可以通过将柄部组件350的鞍形表面130定位在手部关节的拇指/食指蹼处实现,如此前所述。第二个固定区域是通过将弯曲稳定性突出352定位在固定的柄部122的后部来实现的,以在柄部组件350与掌心之间实现接触。这样即可在掌心获得大面积接触,而不是在固定的柄部122的基部354处获得小面积接触。柄部组件350的鞍形表面130得以维持,而无需改变最佳握持跨度356。由于弯曲稳定性突出352的弯曲宽阔,因此无论手大小如何均可获得接触区域。假如两个固定点以机械方式阻止通过施加实际很小的手部力量使器械的远端尖端绕鞍形表面130旋转,从而可例如松开手指头来启动微小的控件,如远侧旋钮134、拨动开关132和触发器120。弯曲稳定性突出352可以形成为柄部组件352的固定的柄部122的长度组成部分,也可以通过向固定的柄部122附加更柔软、更舒适的材料形成。
图89和图90示出了具有形成于固定的柄部122的两侧上的凸起362的柄部组件360的一个实施例。凸起362为本文所述柄部组件提供了额外的固定点并具有人体工程学方面的优点。在一个实施例中,凸起362使得能够在解剖或其他类型的外科手术期间对柄部组件360进行额外的控制。在操作该器械的同时使用某些超声外科手术器械时,一些使用者可能会感到疲劳或控制度降低。一个可能导致疲劳或控制度降低的因素是使用者在使用除拇指和食指外的其他手指在细长触发器钩124上向外推动时,位于拇指与食指之间的固定的柄部122受到挤压。因此,耳状凸起362附接或形成在柄部组件360的两侧,从而为使用者提供边缘或表面接触区域以接合拇指。凸起362在外科手术(例如解剖)期间可稳定柄部组件360,并且通过挤压拇指与食指之间的柄部组件360来缓解部分疲劳。凸起362可以包括脊364,以允许拇指在方向366能够利用相对表面来抵消扩展力,而不是依靠通过挤压拇指和食指产生的摩擦和压缩。凸起可使用柔顺材料来形成纹理或包覆成型,以改善使用者佩戴外科手术手套时的握持和感觉。也可以使其的轮廓不会形成拇指或食指可抵靠的任何尖角或不舒适边缘。
各种实施例包括刀片和具有已经叙述过的近侧组织垫部分、远侧组织垫部分和组织垫插入部分的夹臂组件。夹臂组件相对于刀片的枢转运动可能会因在夹臂组件的夹臂部分上提供了一对枢转点而受到影响,其中夹臂组件通过焊接销紧固件或其他紧固装置与超声外科手术器械接合。组织垫段可以通过机械方式附接到夹臂上,包括(例如)铆钉、胶水、粘接剂、环氧树脂、压力装配或本领域已知的任何其他紧固装置。此外,组织垫段可以通过任何已知的方式可拆卸地附接到夹臂上。
在各种实施例中,夹臂可以具有T型狭槽,用来接纳近侧组织垫段、远侧组织垫段和组织垫插入段的T型凸缘。在各种实施例中,一体式组织垫组件可以具有近侧组织垫段、远侧组织垫段和组织垫插入段,并且还具有接纳到夹臂组件的T型狭槽内的T型凸缘。可以设想包括鸠尾狭槽和楔形凸缘的其他构型。正如本领域的技术人员可以理解的那样,凸缘和对应的狭槽具有可供选择的形状和尺寸,以将组织垫段可拆卸地固定到夹臂上。
更换近侧组织垫段、远侧组织垫段和/或组织垫插入段的方法包括以下步骤中的一个或多个:a)使夹臂组件脱离超声外科手术器械;b)从夹臂上移除组织垫段中的至少一个;c)将至少一个新的或修复的组织垫段插入夹臂;以及d)将夹臂组件与超声外科手术器械接合。在上述拆卸和更换的过程中,新的或修复的近侧组织垫段、远侧组织垫段和组织垫插入段可以为多个独立的段或为一体式构造。
更换近侧组织垫段、远侧组织垫段和/或组织垫插入段的另一个方法包括以下步骤中的一个或多个:a)开启夹臂上的凸缘;b)从夹臂上移除组织垫段中的至少一个;c)在夹臂上插入至少一个新的或修复的组织垫段;以及d)关闭夹臂上的凸缘。在上述拆卸和更换的过程中,新的或修复的近侧组织垫段、远侧组织垫段和组织垫插入段可以为多个独立的段或为一体式构造。
优选地,在外科手术前实施本文所述的各种实施例。首先,获取新的或用过的器械,并根据需要进行清洗。然后可对器械进行消毒。这可通过本领域技术人员已知的任何数目的方法来完成,包括(例如)β或γ辐射、环氧乙烷消毒和/或蒸汽。在一种消毒技术中,将器械置于闭合并密封的容器中,例如塑料或袋中。然后将容器和器械置于可穿透该容器的辐射场中,例如γ辐射、X射线或高能电子消毒。消毒措施将杀死器械上和容器中的细菌。然后可将消毒后的器械保存在消毒容器中。该密封容器将器械保持在无菌状态,直到在医疗设施中开启该容器。
虽然本文已描述了各种实施例,但可以对这些实施例实施多种修改和变型。例如,可以采用不同类型的端部执行器。此外,可以使用所述实施例的组合。例如,凹形刀片顶端可以涂覆有疏水材料。此外,虽然其中公开了某些组件用的材料,但也可以使用其他材料。上述具体实施方式和下述权利要求书旨在涵盖所有此类修改和变型。
以引用方式全文或部分地并入本文的任何专利、公布、或其他公开材料仅在所并入的材料不与本发明所述的现有定义、陈述、或其他公开材料相冲突的范围内并入本文。同样地并且在必要的程度下,本文明确阐述的公开内容取代了以引用方式并入本文的任何冲突材料。如果任何材料或其一部分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,那么仅在所并入的材料与现有公开材料之间不产生冲突的程度下才将其并入本文。
Claims (13)
1.一种外科手术器械柄部组件,包括:
外壳,所述外壳具有近端和远端;
近侧开口,所述近侧开口在所述外壳的所述近端处形成;
远侧开口,所述远侧开口在所述外壳的所述远端处形成,
所述近侧开口和所述远侧开口限定纵向轴线;
固定的柄部,所述固定的柄部从所述纵向轴线向下地延伸并限定第一近侧接触表面、第一鞍形表面和第一稳定性尾部;
触发器,所述触发器可枢转地附接到所述外壳并且能够相对于所述柄部可枢转地活动;和
适配器,所述适配器能够可拆卸地附接到所述柄部,以扩展或放大所述固定的柄部的尺寸,
所述适配器包括:限定内表面和外表面的主体,所述内表面形成接纳所述固定的柄部的开口,所述内表面限定与所述固定的柄部的所述第一近侧接触表面、所述第一鞍形表面和所述第一稳定性尾部形状相反的轮廓,所述外表面限定形成第二接触表面、第二鞍形表面和第二稳定性尾部的轮廓。
2.根据权利要求1所述的外科手术器械柄部组件,包括连接到所述远侧开口的远侧旋钮,所述远侧旋钮包括多个凹槽。
3.根据权利要求2所述的外科手术器械柄部组件,其中所述远侧旋钮包括弹性材料。
4.根据权利要求1所述的外科手术器械柄部组件,包括可枢转地连接到所述外壳的所述远端的拔动开关。
5.根据权利要求1所述的外科手术器械柄部组件,包括在所述近侧接触表面上形成的弯曲稳定性突出。
6.根据权利要求1所述的外科手术器械柄部组件,包括在所述外壳上形成的至少一个凸起。
7.根据权利要求1所述的外科手术器械柄部组件,其中所述近侧接触表面由从第一参考点测得的第一半径限定,所述鞍形表面由从第二参考点测得的第二半径限定,所述稳定性尾部由从第三参考点测得的第三半径限定。
8.一种外科手术器械柄部组件,包括:
外壳,所述外壳具有近端和远端;
近侧开口,所述近侧开口在所述外壳的所述近端处形成;
远侧开口,所述远侧开口在所述外壳的所述远端处形成,
所述近侧开口和所述远侧开口限定纵向轴线;和
固定的柄部,所述固定的柄部从所述纵向轴线向下地延伸并限定第一近侧接触表面、第一鞍形表面和第一稳定性尾部;
远侧旋钮,所述远侧旋钮连接到所述近侧开口并包括多个凹槽;和
适配器,所述适配器能够可拆卸地附接到所述柄部,以扩展或放大所述固定的柄部的尺寸,
所述适配器包括:限定内表面和外表面的主体,所述内表面形成接纳所述固定的柄部的开口,所述内表面限定与所述固定的柄部的所述第一近侧接触表面、所述第一鞍形表面和所述第一稳定性尾部形状相反的轮廓,所述外表面限定形成第二接触表面、第二鞍形表面和第二稳定性尾部的轮廓。
9.根据权利要求8所述的外科手术器械柄部组件,其中所述远侧旋钮包括弹性材料。
10.根据权利要求8所述的外科手术器械柄部组件,包括可枢转地连接到所述外壳的所述远端的拨动开关。
11.根据权利要求8所述的外科手术器械柄部组件,包括在所述近侧接触表面上形成的弯曲稳定性突出。
12.根据权利要求8所述的外科手术器械柄部组件,包括在所述外壳上形成的至少一个凸起。
13.根据权利要求8所述的外科手术器械柄部组件,其中所述近侧接触表面由从第一参考点测得的第一半径限定,所述鞍形表面由从第二参考点测得的第二半径限定,所述稳定性尾部由从第三参考点测量的第三半径限定。
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2008
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- 2008-10-03 AU AU2008308606A patent/AU2008308606B2/en not_active Ceased
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US11819197B2 (en) | 2021-01-23 | 2023-11-21 | ClearCam, Inc. | Imaging element cleaning device with imaging device fitment adjustability |
US11857382B2 (en) | 2021-02-09 | 2024-01-02 | ClearCam, Inc. | Devices, apparatuses, systems and methods for facilitating cleaning of an imaging element of an imaging device |
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AU342219S (en) | 2012-04-30 |
US8623027B2 (en) | 2014-01-07 |
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JP2013208456A (ja) | 2013-10-10 |
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JP5863704B2 (ja) | 2016-02-17 |
USD661804S1 (en) | 2012-06-12 |
USD661803S1 (en) | 2012-06-12 |
CA2701962A1 (en) | 2009-04-09 |
CA2701962C (en) | 2016-05-31 |
WO2009046234A2 (en) | 2009-04-09 |
AU2008308606B2 (en) | 2014-12-18 |
US20120184946A1 (en) | 2012-07-19 |
USD661802S1 (en) | 2012-06-12 |
AU2008308606A1 (en) | 2009-04-09 |
USD661801S1 (en) | 2012-06-12 |
US9486236B2 (en) | 2016-11-08 |
EP2796102A2 (en) | 2014-10-29 |
EP2217157A2 (en) | 2010-08-18 |
CN101883531A (zh) | 2010-11-10 |
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