CN101511286B - 用于切割和凝结的超声装置 - Google Patents

用于切割和凝结的超声装置 Download PDF

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CN101511286B
CN101511286B CN2006800426027A CN200680042602A CN101511286B CN 101511286 B CN101511286 B CN 101511286B CN 2006800426027 A CN2006800426027 A CN 2006800426027A CN 200680042602 A CN200680042602 A CN 200680042602A CN 101511286 B CN101511286 B CN 101511286B
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ultrasonic
surgical instrument
clamp
cutter
waveguide
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CN101511286A (zh
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S·E·艾希曼
K·M·科瓦尔斯基
K·S·克雷默
M·R·拉姆平格
A·K·玛丹
M·C·米勒
A·C·沃格莱
E·T·威纳
J·E·杨
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Ethicon Endo Surgery Inc
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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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/1604—Chisels; Rongeurs; Punches; Stamps
    • A61B17/1606—Chisels; Rongeurs; Punches; Stamps of forceps type, i.e. having two jaw elements moving relative to each other
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/28—Surgical forceps
    • A61B17/2812—Surgical forceps with a single pivotal connection
    • A61B17/2841—Handles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/1613—Component parts
    • A61B17/162—Chucks or tool parts which are to be held in a chuck
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8875—Screwdrivers, spanners or wrenches
    • 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
    • A61B2017/00424—Surgical instruments, devices or methods, e.g. tourniquets with special provisions for gripping ergonomic, e.g. fitting in fist
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00477—Coupling
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00681—Aspects not otherwise provided for
    • A61B2017/00738—Aspects not otherwise provided for part of the tool being offset with respect to a main axis, e.g. for better view for the surgeon
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/28—Surgical forceps
    • A61B17/2812—Surgical forceps with a single pivotal connection
    • A61B17/282—Jaws
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
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    • A61B2017/320072—Working tips with special features, e.g. extending parts
    • A61B2017/320074—Working tips with special features, e.g. extending parts blade
    • A61B2017/320075—Working tips with special features, e.g. extending parts blade single edge blade, e.g. for cutting
    • 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
    • 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
    • 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

一种超声夹钳凝结器组件，其被构造为在精确和精细的外科手术过程中允许选择性地进行组织的切割、凝结和精确解剖。该组件包括夹钳机构，夹钳机构包括凸轮安装在器械的远侧部分处的夹钳臂，夹钳臂被特别构造为产生所需水平的组织夹钳力。平衡的刀提供功能不对称部，用于改善刀尖端处的可视性，刀的多条边和多个面被设计用于提供多种组织处理：夹钳凝结、夹钳切割、抓持、反向切割、解剖、点凝结、尖端刺入和尖端割痕。该组件的特征还在于手动致动，其被构造成为医生提供人体工程学的握持和操作。无论用左手还是右手来握持外科器械，手动开关都位于使用者食指或中指的自然轴向运动范围内。

Description

用于切割和凝结的超声装置
本申请要求享有2005年10月14日提交的序列号为60/726625的美国临时专利申请的优先权。
技术领域
本发明整体上涉及超声外科系统，更具体而言，本发明涉及一种超声装置，该装置被优化以允许医生在诸如甲状腺切除等精确且精细的外科手术中进行组织的切割、凝结和精细解剖。
背景技术
由于超声外科器械的独特性能，这种器械被日益广泛地应用在外科手术中。根据具体的器械构造和操作参数，超声外科器械能够基本上同时提供组织切割和凝结止血，从而使对患者的损伤最小。切割动作通常是通过位于器械远端处的端部执行器来实现的，端部执行器向与其接触的组织传递超声能量。这种特性的超声器械能够被构造成用于开放式外科应用、腹腔镜或内窥镜外科手术(包括机器人辅助的手术)。
已经开发了包括夹钳机构的超声外科器械，夹钳机构用于将组织压抵到端部执行器的刀上，以将超声能量传到患者的组织。这样的装置(有时被称作夹钳凝结器剪刀或超声切割器)公开在美国专利No.5322055、5873873和6325811中。
医生通过挤压手柄或者把手来致动夹钳臂，以使夹钳垫压抵到刀上。
夹钳凝结器剪刀目前的一些设计利用脚踏板来为外科器械供给能量。医生操作脚踏板的同时向手柄施加压力，以将组织压在钳口和刀之间，从而致动提供能量的发生器，该能量传递至切割刃以切割和凝结组织。这种类型的器械致动的主要缺陷包括医生在寻找脚踏板时无法将注意力完全集中在手术部位，该脚踏板在手术过程中会防碍医生的运动并且在长时间的手术过程中医生的腿部容易疲乏。
已经披露了平衡弯曲的端部执行器的多种方法，所述方法包括沿着端部执行器重新配置质量。这些方法的缺点在于：i)弯曲区域的应力高，这使得端部执行器如果在外科手术过程中与金属接触则更易于断裂；ii)有效长度较短，这限定了能够被施以手术的血管的尺寸(有效长度被定义为从刀的远端到位移为其远端处的位移的一半的位置的长度)；和/或iii)不能单独地平衡正交的位移。
夹钳凝结器剪刀目前的一些设计使用手柄，该手柄可以是手枪式把手或剪刀把手的设计。剪刀把手的设计可以具有不可移动并固定至外壳的一个拇指或手指把手和一个可移动的拇指或手指把手。对于使用诸如止血钳等其它开放式外科器械的医生来说，这种类型的把手可能不是特别熟悉，因为在诸如止血钳之类的外科器械中，拇指和手指把手可以彼此相对移动。
当前设计的剪刀臂能够围绕与工作元件的纵向轴线垂直的固定枢轴或旋转点旋转。这种方式是受限制的，因为两个臂之间的相对运动完全旋转。这个特征对控制两个被完全闭合的工作端之间的压力分布产生了限制。
夹钳凝结器剪的当前的一些设计不是特别地设计用于需要精确解剖、切割和凝结的精细手术。一种示例性的手术是需要进行精确解剖、切割和凝结以避开重要的血管和神经束的甲状腺切除。
因此需要提供一种能够克服当前器械的一些缺陷的超声外科器械。这里描述的超声外科器械克服了这些缺陷。
发明内容
体现本发明原理的超声夹钳凝结器组件被构造为在外科手术过程中选择性地进行组织解剖、切割、凝结和夹紧。
本发明的第一实施方式的第一种形式是一种超声波导管，其包括：连接到所述波导管的所述远端上的超声致动的刀；具有组织接合表面的组织垫，所述组织接合表面具有第一宽度和比所述第一宽度小的第二宽度；限定远侧部和近侧部并且能够相对于所述刀移动的夹钳构件，其具有打开位置和闭合位置，在所述打开位置中，所述夹钳构件的至少一部分与所述刀间隔开，在所述闭合位置中，所述夹钳构件邻近所述刀，用于将组织夹钳在所述组织垫和所述刀之间。
第一实施方式的第二种形式是，所述夹钳构件在第一平面内限定第一尺寸和第二尺寸，所述第一尺寸大于所述第二尺寸，所述夹钳构件还在第二平面内限定第一尺寸和第二尺寸，所述第一尺寸大于所述第二尺寸。
第三实施方式的第一种形式包括一种组装已消毒的超声夹钳凝结器装置的方法，所述方法包括以下步骤：提供具有近端和远端的超声波导管；提供连接到所述波导管的所述远端上的超声致动的刀；提供具有凸缘和组织接合表面的组织垫，所述组织接合表面具有第一宽度和比所述第一宽度小的第二宽度；和提供能够相对于所述端部执行器移动的夹钳构件，其具有打开位置和闭合位置，在所述打开位置中，所述夹钳构件的至少一部分与所述刀间隔开，在所述闭合位置中，所述夹钳构件邻近所述刀，用于将组织夹钳在所述组织垫和所述刀之间，所述夹钳构件包括用于可滑动地接收所述凸缘的槽；将所述凸缘可滑动地接合在所述槽中；并且对所述夹钳凝结器装置进行消毒。
第四实施方式的第一种形式的超声外科器械包括：用于容纳换能器并且还限定纵向轴线的外壳；定位在所述外壳上的第一开关，用于通过使用者的一个或多个手指沿与所述纵向轴线平行的方向进行启动，并且第一开关还电连接到发生器，用于向所述发生器提供电信号，以控制由所述换能器传递的超声能量的第一水平。
第四实施方式的第二种形式的超声外科器械还包括定位在所述外壳上的第二开关，用于通过使用者的一个或多个手指沿与所述纵向轴线平行的方向进行启动，并且第二开关还电连接到发生器，用于向所述发生器提供电信号，以控制由所述换能器传递的超声能量的第二水平。
第五实施方式的第一种形式的超声外科器械包括：限定纵向轴线的超声波导管，所述超声波导管具有近端、最远侧节点和远端；超声致动的刀，其定位在所述波导管的远端处，并且在第一平面内限定一功能不对称部；位于所述最远侧节点的远侧以及所述刀的近侧的第一平衡不对称部；以及位于所述最远侧节点的近侧的第二平衡不对称部。
第六实施方式的第一种形式的超声外科器械包括：外壳；具有近端的外部护罩，所述近端连接到所述外壳；定位在所述外部护套中的超声波导管；超声致动的刀，所述超声致动的刀定位在所述波导管的远端处；和致动杆，其用于操作位于所述杆的远端处的夹钳臂。所述致动杆包括凸轮构件，所述凸轮构件可操作地接合所述外部护套，所述致动杆的运动使所述夹钳臂相对于所述刀在打开和夹钳位置之间定位。
在第六实施方式的第二种形式的超声器械中，固定的指环限定长度为L的开口，所述外壳和换能器的尺寸能够用于将所述外科器械在所述外壳处的重心定位在长度L的尺寸范围内。
第一实施方式的第一种形式的用于超声夹钳凝结器装置的转矩扳手包括：手动扳手主体；可动地安装在所述扳手主体上的悬臂；定位在所述悬臂的远端的至少一个齿；以及可旋转地安装在所述手动扳手上的适配器，所述适配器包括用于可操作地接合所述齿的凸轮。
附图说明
在所附权利要求中具体地提出本发明的新颖特征。但是，通过结合附图参考以下描述，可以最好地理解发明本身操作的模式和方法，其中：
图1是根据本发明的超声外科器械的一种实施方式的透视图；
图2是图1的立体装配图；
图3A是根据本发明的波导管和刀的一种实施方式的透视图；
图3B是图3A的波导管和刀的正视图；
图3C是根据本发明的波导管和刀的一种替代实施方式的正视图；
图3D是根据本发明的波导管和刀的一种替代实施方式的正视图；
图3E是根据本发明的波导管和刀的一种替代实施方式的正视图；
图3F是图3E的波导管和刀的实施方式的替代视图；
图3G是根据本发明的波导管和刀的一种替代实施方式的正视图；
图4是示出本发明和已有技术的位移廓线的曲线图；
图5是示出本发明和已有技术的位移廓线的替代曲线图；
图6A是图3E-F的波导管和刀的正视图，图示了刀的曲率半径的一种实施方式；
图6B是图6A的刀和弧形切口的一种实施方式的分解图；
图6C是图6A的实施方式的替代视图；
图6D是图6B的实施方式的剖视图；
图7A是根据本发明的端部执行器的正视图；
图7B是图7A的端部执行器的平面图；
图8是根据本发明的夹钳构件的远端的从其近侧观察的透视图；
图9A是根据本发明的组织垫的平面图；
图9B是图9A的组织垫的相对面的平面图；
图9C是图9A-B的组织垫的正视图；
图10A是夹钳构件的一种替代形式的透视图；
图10B是图10A的夹钳构件和第一组织垫的透视图；
图10C是图10A的夹钳构件和第一、第二组织垫的透视图；
图11A-B是第一和第二组织垫的替代形式；
图11C是用于图11A-B的组织垫的夹钳臂的一种替代形式的透视图；
图11D是图11C的夹钳臂的一种替代视图；
图11E是图11A-D的装配在一起的夹钳臂和组织垫组件的剖视图；
图12A是具有远侧连接点的夹钳臂的一种替代实施方式的透视图；
图12B是具有远侧连接构件的组织垫的一种替代实施方式的透视图；
图12C是图12A-B的装配在一起的夹钳臂和组织垫的透视图；
图13是根据本发明的超声器械的远端的局部视图；
图14是夹钳臂的一部分、夹钳构件和凸轮构件的正面立体图；
图15是外部护罩和凸轮槽的立体图；
图16A是根据本发明的超声器械和按钮组件的正视图；
图16B是根据本发明的两件式按钮组件的正视图；
图16C是图示开关外壳、换能器、波导管和外壳之间的交界面的正面透视图；
图16D是根据本发明的开关外壳的正面透视图；
图16E是图16D的开关外壳的一种替代视图；
图16F是根据本发明的弯曲电路的视图；
图16G是手动开关电路的电气示意图；
图17A是根据本发明的可以被使用者抓持的超声器械的正视图；
图17B是根据本发明的超声器械的手指和拇指的交界面的立体图；
图18是根据本发明的可以被使用者抓持并限定重心的超声器械的正视图；
图19A是根据本发明的两件式转矩扳手的透视图；
图19B是根据本发明的手动扳手的透视图；
图19C是图19B的手动扳手的正视图；
图19D是手动扳手的远端的端面剖视图，其中，描述了悬臂和齿形几何结构；
图19E是适配器的剖视图，其中，描述了花键齿轮的几何结构；
图19F是用于根据本发明的手动扳手的适配器的透视图；以及
图19G是与根据本发明的超声器械接合的手动扳手的局部透视图。
具体实施方式
在详细解释本发明之前，应注意，本发明不将其应用或使用限制为在附图和说明书中描述的构造和零部件的布置的细节。本发明的示例性实施方式可在其它实施方式、改变和变化中执行或包含在其它实施方式、改变和变化中，并可以多种方式实践或实施。此外，除非另外指明，为方便读者，这里采用的术语和表述是为描述本发明的示例性实施方式的目的而选，而不是出于限制本发明的目的。
此外，应理解，下面描述的实施方式、实施方式的表现形式、例子等的任何一个或多个可与下面描述的其它实施方式、实施方式的表现形式、例子等的任何一个或多个组合。
本发明特别地涉及改进的超声外科夹钳凝结器装置，其被构造为在包括诸如甲状腺切除等精细外科手术在内的外科手术过程中实现组织切割、凝结和/或夹紧。本装置可以被构造为用在开放式外科手术中。多样化的使用是通过选择性地使用超声能量来实现的。当装置的超声部件未受激励时，可以根据需要容易地抓住组织并对组织进行操作，而不切割或损伤组织。当超声部件受到激励时，该装置允许抓住组织，与超声能量进行连接以实现组织凝结，其中施加增大的压力来有效地实现组织切割和凝结。如果需要，通过适当地操作超声刀，超声能量可以施加到组织，而不需要使用装置的夹钳机构。
如以下的描述中所清楚地看到的，由于夹钳凝结器装置的结构简单，其被特别构造为一次性使用。同样，可以设想该装置与外科系统的超声发生器单元结合使用，由此，来自发生器单元的超声能量为该夹钳凝结器装置提供所需的超声致动。应当理解，体现本发明原理的夹钳凝结器装置能够被构造为非一次性使用或者是多次使用的，并且与相关的超声发生器单元不可拆卸地形成一体。然而，对于单个患者使用该装置来说，该夹钳凝结器装置与相关超声发生器单元的可拆卸连接在目前是优选的。
具体参照图1和2，图示了外科系统19的一种实施方式，该外科系统19包括根据本发明的超声外科器械100。外科系统19包括超声发生器30和超声外科器械100，超声发生器30经由线缆22连接到超声换能器50上。应当注意，在一些应用中，超声换能器50被称作“手持组件”，因为外科系统19的外科器械被构造为使得医生在各种手术和操作过程中可以抓住并操作超声换能器50。合适的发生器是Cincinnati，Ohio的Ethicon Endo-Surgery，Inc.出售的GEN04(也称作发生器300)。合适的换能器在2006年10月10日提交的(代理人卷号为END5747USNP1)题为MEDICAL ULTRASOUND SYSTEMAND HANDPIECE AND METHODS FOR MAKING AND TUNING的共同未决美国专利申请中公开，该专利申请的内容通过引用包含在此。
超声换能器50和超声波导管80一起提供了本外科系统19的声学组件，当声学组件由发生器30供能时，声学组件提供用于外科手术的超声能量。外科器械100的声学组件一般包括第一声学部分和第二声学部分。在本实施方式中，第一声学部分包括超声换能器50的超声有效部分，第二声学部分包括传输组件71的超声有效部分。此外，在本实施方式中，第一声学部分的远端例如通过螺纹连接可操作地连接到第二声学部分的近端。
超声外科器械100包括组合式手柄组件68，其适于使操作者与容纳在换能器50中的声学组件的振动隔开。手柄组件68的形状可以形成为能够由使用者以传统方式握持，但可以想到，该超声外科器械100原则上通过剪刀状设置来握持和操作，该剪刀状设置由器械的手柄组件提供，如下所述。尽管图示了组合式的手柄组件68，但该手柄组件68可以包括单个或一体的部件。通过将换能器插入到手柄组件68中，超声外科器械100的近端接收超声换能器50的远端并与该远端装配在一起。超声外科器械100可以作为一个单元从超声换能器50拆装。超声外科器械100可以包括手柄组件68，该手柄组件68包括配合外壳部分69、70和超声传输组件71。超声外科器械100的细长传输组件71从器械手柄组件68垂直地延伸。
手柄组件68可以由诸如聚碳酸酯或液晶聚合物等耐用塑料制成。可以想到手柄组件68可以替代地由包括其它塑料、陶瓷或金属在内的多种材料制成。然而，传统的未填充的热塑性塑料的导热率仅约0.20W/m°K(Watt/meter-°Kelvin)。为了改进器械的热耗散，可以使用导热率在20-100W/m°K范围内的诸如高耐热性树脂液晶聚合物(LCP)、聚亚苯基(PPS)、聚醚醚酮(PEEK)和聚砜等热传导热塑性塑料制造手柄组件。PEEK树脂是填充有能够导电的氮化铝或氮化硼的热塑性塑料。导热树脂有助于控制较小的器械中的热量。
传输组件71包括波导管80和刀79。应当注意，在一些应用中，传输组件有时被称作“刀组件”。适于将超声能量从换能器50传输至刀79的尖端的波导管80可以是挠性的、半挠性的或刚性的。如本领域所公知的，波导管80还可以被构造为放大通过波导管80传输至刀79的机械振动。波导管80还可以进一步具有控制沿着波导管80的纵向振动的增益的部件和将波导管80调节到系统谐振频率的部件。具体来说，波导管80可以具有任何适当的横截面尺寸。例如，波导管80可以具有基本上均匀的横截面，或者波导管80可以在不同的部分逐渐变细或者可以沿着其整个长度变细。
超声波导管80的长度例如可以基本上等于二分之一系统波长的整数倍(nλ/2)。优选地，超声波导管80和刀79可以由实心轴制造，该实心轴由诸如钛合金(即，Ti-6Al-4V)、铝合金、蓝宝石、不锈钢或任何其它声学相容材料等能够有效传播超声能的材料制成。
超声波导管80还可以包括至少一个径向孔或窗孔66，该径向孔或窗孔66基本上垂直于波导管80的纵向轴线延伸穿过波导管。可以定位在节点处的窗孔66被构造为接收连接器销27，如下所述，该连接器销27将波导管80连接至手柄组件70。
刀79可以与波导管80成为一体并形成为单个单元。在当前实施方式的替代表现形式中，刀79可以通过螺纹连接、焊接接头或其它连接机构来连接。刀79的远端设置为靠近腹点85，以在没有用组织加载声学组件时将声学组件调节到优选的谐振频率fo。当超声换能器50被供给能量时，刀79的远端或刀尖端79a被构造为例如在大约10至500微米的峰-峰范围内基本上沿纵向(沿x轴)运动，例如在55500Hz的预定振动频率fo下，刀79的远端或刀尖端79a优选在大约20至大约200微米的范围内沿纵向运动。刀尖端79a也优选沿y轴以沿x轴运动的大约1％至大约10％振动。
刀尖端79a提供功能不对称部或弯曲部分，用于改善刀尖端处的可视性，使得医生能够确认刀79延伸穿过被切割或凝结的组织。这对于确认较粗血管的边缘尤其重要。该几何结构还通过更加接近地复制生物结构的曲率来改善组织接触。刀79设有多条边和多个表面，它们被设计用于提供多种组织处理：夹钳凝结、夹钳切割、抓持、反向切割、解剖、点凝结、尖端刺入和尖端割痕。
刀尖端79a通常被称作功能不对称部。即，刀(在功能上，刀提供多种组织处理)位于波导管80的纵向轴线的外侧(即，与纵向轴线不对称)，并且相应地在超声波导管中产生不平衡。如果不对所述不平衡进行校正，接着就会出现不希望的热、噪声并且影响组织处理。
通过在刀功能不对称部附近设置一个或多个平衡不对称部或平衡特征，可以使尖端在y和z轴上的不期望的移动最小化，并因此使效率最大化并能改进组织处理。
现在参考图3A-G，传输组件71包括一个或多个设置在刀79处、最远侧节点84的近侧和/或远侧处的平衡特征。此外，位于波导管80处的平衡特征的形状被构造成用以使在y和z轴上的两种正交的模态分别平衡。平衡特征的尺寸、形状和位置能够适应性地减小刀79处的应力，从而使有效长度更长并且分别平衡两种正交的模态。
图3A-B示出位于波导管80的节点84远侧的单个平衡切口82。在该实施方式中，平衡切口82具有侧壁和底部切口，侧壁与波导管80的纵向轴线垂直，底部切口平行于波导管80的纵向轴线。在该实施方式中，在操作过程中平衡切口82处具有较高应力，但该处远离刀79处的更敏感的弯曲区域。
图3C示出两个平衡特征82和82a，分别位于节点84的远侧和近侧。在节点84的近侧增加第二平衡切口82a能进一步消除正交的弯曲模态，由此提供更单一的纵向运动(x方向)并且消除重叠的弯曲模态(y和z方向)。相应地，刀79被更好地平衡且具有更长的有效长度。
图3D示出两个平衡特征82c和82a，分别位于节点84的远侧和近侧。平衡特征82c的倾斜底部切口允许在z方向上单独平衡弯曲模态。
图3E-F示出两个平衡特征82和82d，分别位于节点84的远侧和近侧。平衡特征82d的侧壁相对于彼此在x-z平面上倾斜，并且用于在y方向上单独平衡弯曲模态。倾斜侧壁限定的夹角在1°和大约90°之间，优选在大约15°和大约25°之间，更优选在大约19°和大约21°之间。在每个平衡特征处去除的重量是多个参数的函数，所述多个参数包括刀尖端79a处的曲率半径和消除y和z方向上的重复的弯曲模态所需的水平。在一个示例性例子中，平衡切口82代表重量减轻了大约0.003至大约0.004oz.，最好为大约0.0034oz.。平衡切口82d代表重量减轻了大约0.004oz.至大约0.005oz.，最好为大约0.0043oz。
图3G示出平衡特征82和位于弯曲的刀区域中的一个平衡切口82e，平衡特征82和82e均位于节点84的远侧。由于横向模态与作为纵向模态频率的基频具有较宽的频率差距，因此平衡切口82e允许进行平衡并改进声学特性。
本领域技术人员可以清楚地理解，平衡特征82至82e的任意结合都是可以的，以使波导管和弯曲刀平衡。
图4示出由图3E的平衡切口特征产生的曲线图，与由EthiconEndo-Surgery，Inc.出售的LCS-C5超声夹钳凝结器所能得到的沿着纵向位移方向的有效长度相比，本发明使得沿着纵向位移方向的有效长度增加了1.3mm(其中，y轴代表沿着刀尖端79a任意位置的位移和在刀尖端79a的最远侧端处的位移之间的比值)。对于切割和凝结较粗的脉管，例如5-7mm的脉管来说，具有较长的有效长度是所期望的。
图5示出由图3E的平衡特征产生的曲线图，与LCS-C5超声夹钳凝结器所能得到的有效长度相比，本发明使得有效长度(沿着x、y和z方向上的位移矢量合)增加了2.5mm，这对用来切割和凝结较粗的脉管，例如5-7mm的脉管来说是所期望的。
再参考图1和2，外部管状构件或外部护罩72安装在手柄组件70的最近端。远侧护罩76安装在外部护罩72的远端上。外部护罩72和远侧护罩76可以通过扣合、压配合、粘合或其它机械方法来安装。端部执行器81从远侧护罩76向远侧延伸，端部执行器81包括与一个或多个组织垫58结合的刀79和夹钳构件56，夹钳构件56通常也称作钳口。密封件83可以设置在最远侧的节点84处并最靠近端部执行器81，以减少位于波导管80与远侧护罩76之间的区域中的组织、血液和其它材料的通过。密封件83可以具有任何公知的结构，例如在节点84处的O形环或包覆成型的硅酮。
现在参考图6A-D和7A-B，刀79和与其关联的夹钳构件56一起弯曲。图示仅为示意性的，刀79和对应的夹钳构件56可以为本领域技术人员公知的任何形状。但是，本发明的一个优点在于，能实施更精确、更精细的外科手术。本发明是多功能的，能用于切割、凝结和解剖组织。
精细解剖的能力主要由端部执行器81的变细来实现。端部执行器被变细为两个平面，所述平面模仿典型的止血钳。这允许使用者在组织内形成窗口并且随后更容易地将组织分开。刀79和夹钳构件56在x和z方向上从近端向远端逐渐变细。垫58仅沿z方向变细。即，夹钳垫58的厚度不变，但其在远端处的宽度小于在近端处的宽度。相应地，截面A的表面积大于截面B的表面积。
除了变细之外，在刀79和夹钳构件56的远端处的半径也有助于实施精细解剖。夹钳构件56尖端处的半径大约为0.040英寸，刀半径大约为0.045英寸。
具体参考图6A，刀79由内径R1和外径R2限定，内径R1和外径R2在与纵向轴线相距距离D1处测量。尺寸R1、R2和D1结合前述平衡切口来选择。在一种实施方式中，R1在大约0.80英寸至1.00英寸之间，最好为约0.95英寸；R2在大约0.90英寸至大约1.10英寸之间，最好为约1.04英寸；D1在大约0.90英寸至大约1.10英寸之间，最好为约0.99英寸。
图6B和6D还示出刀79的第二种形式。图示刀79中的弧形切口90设有两个背切削刃92和92a。本领域技术人员应当理解，弧形切口90也在功能对称部的情况下设置平衡不对称部，以助于平衡正交的模态。背切削刃92和92a定位在夹钳垫58(图7B)的相对侧，医生在执行组织切割手术时不需夹钳垫58的辅助。考虑到用于组织解剖的钝半径尖端，弧形切口优选设在刀79的最远侧尖端的远侧，如上所述。在刀79的第二种形式的一个例子中，半径R3扫过角度
Figure S2006800426027D00131
该角度
Figure S2006800426027D00132
在距离纵向轴线D2处测量并起始于距离刀79的远侧尖端距离D3处。在一种实施方式中，R3在大约0.030英寸至大约0.060英寸之间，最好为约0.050英寸；角度
Figure S2006800426027D00133
在大约20°至大约35°之间，最好为大约30°；D2在大约0.90英寸至大约1.10英寸之间，最好为大约0.99英寸；D3在大约0.085英寸至大约0.11英寸之间，最好为009英寸。
在刀79的第三种形式中，图6C示出变细部，其通过相对于轴线的角度Ω来限定，该轴线平行于波导管80的从刀79的近端到刀79的远端的纵向轴线。在一种实施方式中，变细部可以在接触组织垫58(图7A)的刀表面上。替代地，变细部可以通过包括弧形切口90的相对表面来限定。参考图6C，角度Ω为大约0.5°至大约5°，优选为大约1.5°至大约2°。
再参考图2，波导管80定位在手柄组件68的腔59内。为了适当地沿轴向和径向定位波导管80，销27穿过波导管80的开口66(位于节点处)延伸并且接合通道28(通过外壳部分69和70配合形成)。优选地，销27由诸如不锈钢或钛之类的任何相容性金属或者例如聚碳酸酯或液晶聚合物等耐用的塑料制成。在一种实施方式的第一种形式中，销27部分地涂覆有例如硅酮等弹性材料30，其中，销27的延伸穿过波导管80的部分29被涂覆，而销27的与构件69和70接合的部分不涂覆。硅酮使孔66的整个长度与振动刀隔离。从而能高效操作，几乎不会出现过热并且在用于切割和凝结的刀尖端处得到最大超声输出功率。销27的未涂覆绝缘材料的部分使销27稳固地保持在手柄组件68中，如果销27完全涂覆绝缘材料，那么会出现变形且开始活动。
参考图8和9A-C，夹钳构件56的第一形式具有用于容纳一个或多个组织垫的成形槽57。这种构造防止了组织垫的误装，并确保了适当的垫装载在夹钳构件56中的正确位置处。例如，夹钳构件56可以包括：T形槽57，用于接收夹钳垫58的T形凸缘55。两个机械止动件59和59a当被压下时接合夹钳垫58的近端，以将夹钳垫紧固到夹钳构件56内。如本领域技术人员应当理解的，凸缘和相应的槽可以具有替代形状和尺寸，以将夹钳垫紧固到夹钳臂上。图示的凸缘构造仅是示例性的并包含了一种实施方式的具体夹钳垫材料，但是凸缘的具体尺寸和形状可以改变，包括但不限于相同尺寸和形状的凸缘。对于整体的组织垫，凸缘可以是一种构造。此外，其它的翼形止动件也是可以的，并可以包括用于将夹钳垫机械地安装至夹钳臂的任何多种方法，例如，铆接、粘结、压配合或本领域公知的任何其它紧固方式。
参考图10A-C，在替代实施方式的第一种形式中，夹钳垫58包括第一组织垫58b和第二垫部分58a，该第二垫部分58a可以插入垫58b内。组织垫58b可以包括具有锯齿状齿的组织接合表面，近侧部分58a的表面比垫58b平滑。两个分离的部件58a和58b的优点是各个垫可以由不同的材料来构造。例如，具有两件式组织垫允许在远端处使用非常光滑的材料而在近端处使用非常高温的材料，与近端处的高温材料相比，远端处的光滑材料不是特别耐高温，近端处的材料不是特别光滑，因为近端是低幅值的区域。这样的构造使组织垫的材料与刀79的幅值相匹配。
在本发明的替代实施方式的第二表现形式中，夹钳垫58由TEFLON
Figure S2006800426027D00151
或任何其它合适的低摩擦材料形成。夹钳垫58a由基体材料和至少一种与基体材料不同的填充材料形成。近侧夹钳垫58a的表面可以比远侧夹钳垫58b平滑，或者近侧夹钳垫58a还可以具有类似形式的锯齿结构。
可以从本发明的一种或多种表现形式中获得一些益处和优点。使组织垫具有基体材料和至少一种填充材料允许选择具有不同硬度、刚度、润滑性、动摩擦系数、导热系数、耐磨性、热变形温度、玻璃态转变温度和/或熔化温度的基体材料和至少一种填充材料，以提高组织垫的耐磨损性，当使用较高的夹钳力时，这种耐磨损性是很重要的，因为组织垫在较高夹钳力下比在较低夹钳力下磨损得快。在试验中，填有15％石墨的聚四氟乙烯组织垫在7磅的夹钳力下与100％聚四氟乙烯的组织垫在1.5磅夹钳力下具有基本相同的磨损。挠性夹钳臂和/或挠性组织垫也可以提高组织垫的耐磨损性，因为挠性构件可以将负载更均匀地分配在组织垫的整个表面上。该实施方式的进一步的优点和表现形式公开在2004年2月27日提交的序列号为60/548301、共同转让给本发明受让人的美国临时专利申请中。
在替代实施方式的第三种表现形式中，具有基体材料和至少两种填充材料的组织垫允许选择具有不同硬度、刚度、润滑性、动摩擦系数、导热系数、耐磨性、热变形温度、玻璃态转变温度和/或熔化温度的基体材料和至少两种填充材料，以提高组织垫的耐磨损性，当使用较高的夹钳力时，这种耐磨损性是很重要的，因为组织垫在较高夹钳力下比在较低夹钳力下磨损得快。在试验中，填有15％石墨、30％PTFE的聚酰亚胺组织垫在4.5磅夹钳力下与100％聚四氟乙烯的组织垫在1.5磅夹钳力下具有基本相同或比其具有更好的磨损。填有15％石墨、30％PTFE的聚酰亚胺组织垫的优点是增加了热阻，这提高了组织垫整体的耐磨损性。与PTFE夹钳垫的直至大约660°F的有效热阻相比，复合聚酰亚胺组织垫具有直至大约800°F至大约1200°F的有效热阻。替代地，其它材料也可以用于一部分组织垫，例如陶瓷、金属、玻璃和石墨。
图10A-C公开将两部分夹钳垫58a和58b安装至夹钳构件56的一种实施方式的第一种形式。在图10A中，至少两个槽57a和57b的形状被构造成用以接收两个具有对应形状的凸缘55a和55′。在该例子中，T形槽57a接收夹钳垫58a的对应的T形凸缘55a，楔形槽57′接收夹钳垫58b的对应的楔形凸缘55′。
图11A-E示出将夹钳垫58c安装至夹钳臂56c的第二种形式。夹钳垫58c包括一个或多个凸起62，用于插入到夹钳臂56c中的一个或多个对应的孔63中。如果根据本申请还使用一个或多个夹钳垫58d，那么夹钳垫58c还包括用于接收一个或多个夹钳垫58d的对应的孔61。夹钳臂56c具有用于接收凸起62的对应的孔63以及用于接收一个或多个夹钳垫58d的对应的腔64。图11E示出在堆叠之前装配在一起的部件。夹钳垫58d配合在孔61和腔64内，垫58c与夹钳臂56c对准，使得凸起62与倒角孔63对准。凸起62高出夹钳臂56c的顶面，以在堆叠过程中向倒角容积内填充额外的材料。对位于夹钳臂56c上方的凸起62进行加热；凸起产生变形并且呈倒角容积形状。
图12A-C示出将夹钳垫58d安装至夹钳臂56d的第三种形式。除了T形凸缘55之外，夹钳垫58d还包括钩状凸起或夹子65，用于安装至夹钳臂56d的远侧尖端处对应的开口66。在该形式中，夹钳臂56d的远侧尖端打开，夹钳垫58d从远侧向近侧插入，直到钩形夹接合开口66为止。钩形夹65可以被偏置闭合，使得当夹子65接合开口66时，夹子65相对于开口66施加压力。
用于将夹钳垫插在夹钳臂上的方法的第一种形式包括：a)将具有比第二宽度尺寸大的第一宽度尺寸以及第一形状凸缘的第一夹钳垫插入到夹钳臂中，夹钳臂具有接收第一形状凸缘的槽；和b)接合垫止动件，以将夹钳垫紧固在夹钳臂中。在该方法的第二种形式中，夹钳垫包括第二夹钳垫，第二夹钳垫由基体材料和不同于基体材料的至少一种填充材料制成。第二夹钳垫可以具有第二形状凸缘，其用于接合第二形状槽到夹钳臂上。夹钳垫的组织表面可以是平滑的或者具有组织握持特征，例如锯齿结构。
用于替换夹钳垫的方法的第一种形式包括步骤：a)解开垫止动件；b)从夹钳臂移除第一夹钳垫；c)从夹钳臂移除第二夹钳垫，其中，第一或第二夹钳垫中的至少一个具有大于第二宽度尺寸的第一宽度尺寸；d)将第三和第四夹钳垫插入到夹钳臂中，其中，第三或第四夹钳垫中的至少一个具有大于第二宽度尺寸的第一宽度尺寸；和e)接合垫止动件，以将第三和第四夹钳垫紧固在夹钳臂中。在该方法的第二种形式中，第三和第四夹钳垫可以由诸如TEFLON之类的聚合物材料制成，其它夹钳垫可以由基体材料和不同于基体材料的至少一种填充材料制成。夹钳垫的组织表面可以是平滑的或者具有组织握持特征，例如锯齿结构。
参考图13-15，夹钳臂60被构造用于该超声外科器械100并且用于与刀79和夹钳构件56协作动作。夹钳臂60可旋转地安装到外部护罩72的远端上，以下详细描述，并且可连接地安装在拇指环或致动构件34的远端处。夹钳垫58安装在夹钳构件56上，用于与刀79协作，夹钳臂60的旋转运动将夹钳垫定位为基本上平行于刀79并与刀79接触，由此限定组织处理区域。通过这样的结构，组织被抓持在夹钳垫58和刀79之间。夹钳构件56相对于刀79的枢转运动是通过在夹钳臂60上设置一对凸轮构件来实现的，该夹钳臂60与外部护罩72接合。外部护罩72牢固地接至手柄68。
在夹钳臂60的第一种形式中，夹钳臂60包括钳口承载构件60a和配合件60b。钳口承载构件60a包括两个凸轮构件94a和94b，用于与位于外部护罩72的两个对应的凸轮槽95a和95b配合。配合件60b包括两个凸轮构件96a和96b，用于与位于外部护罩72的两个对应的凸轮槽97a和97b配合。对应的凸轮构件94a/94b和96a/96b(以及对应的凸轮槽95a/95b和97a/97b)可以沿着与波导管80的纵向轴线垂直的共同轴线对准，或者可以使凸轮构件偏置以便于装配。构件60a和60b如图13所示经由压配合或扣合固定地安装在一起以形成夹钳臂60。也可以采用本领域技术人员公知的其它安装方法，例如焊接、粘合、螺纹连接等。一旦完成装配，夹钳臂60限定开口93，开口93用于接收外部护罩72，各凸轮构件与各凸轮槽互锁。替代地，构件60a和60b可以装配在外部护罩72周围，所有三个元件在一次操作中配合在一起。凸轮打开和闭合机构的一个优点在于，它能使夹钳臂60和夹钳构件56作旋转运动和线性运动，由此能更好地控制夹钳垫58和刀79之间的压力分布。
在夹钳臂60的第二种形式中，凸轮构件可以由球形元件来替换，所述球形元件与凸轮槽接合。替代地，凸轮构件可以由球形凹部来替换，所述球形凹部用于接收与凸轮槽接合的球轴承。可以使用本领域技术人员公知的其它凸轮机构。
利用牢固的凸轮构件和对应的槽，在夹钳垫58和刀79之间传递的力直接与使用者施加在拇指环35和手指环36处的力相关。在夹钳臂60的第三种形式中，可以将诸如弹性件、线圈或弹簧片之类的力限制元件98插入到一个或多个凸轮槽中，并对端部执行器81处的接合力进行力限制。优选地，弹性件或弹簧的弹簧常数为10-500lb./in.。
外部护罩72、远侧护罩76和夹钳臂60可以由任意数量的生物相容性材料制成，其中，生物相容性材料诸如钛、不锈钢或塑性材料等。然而，优选地，这些元件由7075或6061T6铝制成。铝具有很好的散热性。已有技术的装置的外壳和夹钳臂由不锈钢制成。铝的典型的导热率大约为250W/mK。不锈钢的导热率大约为16W/mK。因此，铝通过相同容积传热的能力近似为不锈钢的15倍。
发明人通过检测相似的输入(夹钳力和刀位移)发现，本发明的操作温度比已有的器械低大约150°F。铝部件能更有效地将垫和刀上的热量吸去，由此保持端部执行器的温度比其它已有器械低。
现在参考图1、2和16A-G，外壳68包括近端、远端和腔59，腔59在外壳68内沿纵向延伸。腔59被构造成用于接收开关组件300和换能器组件50。
在当前实施方式的一种形式中，换能器50的远端螺纹安装到传输杆80的近端上。换能器50的远端也与开关组件300接合，以便向医生提供对外科器械19的手指致动控制。
换能器50包括第一传导环400和第二传导环410，它们如在美国共同未决专利申请(代理人卷号.END5747USNP2)中描述的被稳固地设置在换能器主体50内。
开关组件300包含按钮组件310、弯曲电路组件330、开关外壳350、第一销式导体360和第二销式导体370。开关外壳350呈马鞍形，并通过开关外壳350和外壳部分69、70上的相应支撑安装座支撑在手柄组件68中。外壳350限定了用于弹片开关的第一接收区域353和用于弹片开关的第二接收区域351。
现在具体参考图16D和E，销360和370在一端分别经由导体337和335与弹片开关332和334电连接，在第二端与换能器50的远端电连接。销360和370中的每个具有弹簧加载的尖端361和371，所述尖端361和371与如图16C所示的换能器50接合。每个端部361和371的工作行程为0.050英寸，以允许与装配零件叠加相关的制造公差。两个扳机320和322可滑动地安装在外壳68上，它们分别包括第一半部320a、320b和第二半部322a、322b。图16B示出了扳机320，该扳机320包括脊321a和321b以及接触表面323(由配合表面323a和323b构成)。当完成装配时，扳机320和322可滑动地安装到外壳68上，接触表面323和325分别与弹片开关332和334机械接合。脊321和326在使用者与扳机320和322之间提供交界面。脊321和326能够向使用者提供足够大的表面区域来按压，以致动器械。
在开关组件300的第二种形式中，具有蚀刻在弹性件上的铜轨迹的弹性连接器配合在开关外壳350中，以在换能器50和弯曲电路330之间提供电互联。弹性连接器的一端经由导体337和335与弹片开关332和334电接合。弹性连接器的另一端可滑动地与换能器50的导体400和410接合。弹性连接器的压缩允许的工作行程高达弹性连接器的总高的20％，以允许与装配零件叠加相关的制造公差。
弯曲电路330在按钮321、322和发生器30之间经由换能器50提供了机电接合。弯曲电路包括两个弹片开关332和334，弹片开关332和334通过沿x方向轴向压下按钮321或322来机械地启动。弹片开关332和334是电接触开关，当压下时，它们提供电信号至发生器30，如图16G的电连接示意图所示。弯曲电路330还包含位于二极管封装336中的两个二极管以及本领域技术人员所公知的导体335和337，导体335和337分别连接到销360和370，销360和370又提供电接触至环导体400和410，环导体400和410又连接至线缆22中的导体，线缆22连接至发生器30。
弯曲电路330通常设在开关组件350的通道352内，使得弹片开关332和334与相应的背衬表面351和353相接合。在操作过程中，背衬表面为弹片开关提供了牢固的支撑，如下所述。弹片开关332和334可以通过任何方便的方法(例如粘结)固定地安装到背衬表面351和353。
容易理解，通过压下按钮321和322，相应的接触表面323和324压靠相应的弹片开关332和334，以启动图16G所示的电路。当医生压下按钮321时，发生器将响应一定的能量水平(例如最大(“max”)功率设定)；当医生压下按钮322，发生器将响应一定的能量水平(例如最小(“min”)功率设定)，这符合用于按钮位置和相应功率设定的已经被接受的产业实践。
现在参考图17A-B，按钮轴向启动能减小医生手指上的应力并允许手指在能防止手和腕部应力的更好的人机工程位置处致动作用力。开关移动也能在不是最佳的手部位置处适当地启动按钮，医生在典型的手术过程中经常遇到这种情况。
在每个接触环35和36的近端处分别有凸起37和38，凸起37和38允许医生将他或她的小拇指靠在其上，用于增加控制和舒适度。这也允许医生当夹钳组织时使用小拇指以减小其它手指上的力。每个接触环35和36在内表面和外表面上包括软接触表面，不论手指插入接触环内或握住接触环。该特征使得不同大小的手都能舒适地操作该装置。
参考图18，接触环35和36的长度限定为L。优选地，与换能器50结合的外科器械100的重心定位在长度L范围内，更优选地，在长度L1范围内，最好地，在长度L2范围内。该重心位置使得器械在医生的手中平衡，以便在手术中对器械进行更加精确的控制并能消除手部疲劳。
现在参考图18和19A-E，图示了两件式转矩扳手450。转矩扳手包括手动扳手500和适配器550。在一种实施方式中，手动扳手500设有围绕手动扳手500的中心线以环形方式设置的悬臂501。悬臂501包括齿501a，齿501a在一种实施方式中以相对于悬臂501向内垂直的方式设置。在本发明的一种实施方式中，齿501a被设置成使得凸轮斜面501b相对于臂501和齿501a之间的直角成25°角。腔502在手动扳手500的整个长度上延伸，用于接收适配器550。
适配器550具有纵轴552，在纵轴552的远端设有悬臂翼片554。在轴552的近端是花键齿轮556，花键齿轮556沿着轴552的外圆周垂直地突出。花键齿轮556包括凸轮斜面556a，凸轮斜面556a被设置成相对于轴552的外圆周与花键齿轮556之间的直角成大约23°至大约28°的角。轴552还限定位于花键齿轮556的近侧的侧向开口(未示出)，用于接收弯曲的刀79，如下所述。适配器还包括交界面560，交界面560与轴552刚性连接并且限定用于刚性接合器械19的远端的开口。可选择地，套筒558包围花键齿轮556以防止由于移动零件而钩住手套并形成腔559。
在装配中，转矩扳手开口502与轴552对准，并基本上沿着轴552的整个长度引导直到翼片554向内弯曲并且接合手动扳手500远端处的肩部505(未示出)。手动扳手凸缘503接合可选的套筒558的远端，使得悬臂齿501a可滑动地接合花键齿轮556。凸轮斜面501b可滑动地接合保持器凸轮斜面29b。转矩扳手组件450可滑动地接合器械19的远端并且被刚性地保持在适当的位置。交界面560的平坦表面560b和560a与位于致动构件34(夹钳臂60)远端处的平坦表面565b(图18)和565a(未示出)配合，导轨562可滑动地接合夹钳臂60上的槽564，远侧护罩76和外部护罩72均提供结构支撑以保持适配器550稳固地与器械19接合。
顺时针方向环向运动或转矩通过叶片504施加至手动扳手500。转矩通过臂501和齿501a传递至齿轮556，齿轮556又将转矩分别经由绝缘销27、外部护罩72和夹钳臂组件60传递至波导管80。当使用者施加5-12lbs.转矩时，斜面501b和556致使臂501运动或偏离扳手500的中心线，确保使用者不将波导管80过度地拧紧在换能器50上。当经由叶片504向扳手500施加逆时针方向的转矩时，齿501a和556的垂直平面侧抵接，允许使用者向波导管80和换能器50之间的交界面提供与施加至叶片的力成比例的转矩，以辅助从换能器50上移去器械100。转矩扳手450可以由耐用塑料制成，例如聚碳酸酯或液晶聚合物。可以设想，扳手450可以替代地由多种材料制成，包括其它塑料、陶瓷或金属。
在另一种实施方式(未示出)中，叶片和悬臂组件可以是单独的部件，它们可以通过诸如粘合或胶粘等机械或化学方法来安装。
优选地，在手术前对上述超声夹钳凝结器装置19进行如下处理。首先，获得新的或用过的超声夹钳凝结器装置，如果有必要对该装置进行清洁。然后，可以对超声夹钳凝结器装置进行消毒。在一种消毒技术中，超声夹钳凝结器装置被放置在闭合且密封的容器中，例如塑料袋或高密度聚乙烯合成纸袋(TYVEK袋)。可选择地，超声夹钳凝结器装置能够与包括转矩扳手450的其它部件作为成套器具捆在容器内。容器、超声夹钳凝结器装置以及任何其它部件随后被放置在能够穿透容器的辐射场内，诸如伽玛辐射、x射线或高能电子。辐射线能杀死超声夹钳凝结器装置上和容器内的细菌。然后，经过消毒的超声夹钳凝结器装置能被存储在无菌容器内。密封容器保持超声夹钳凝结器装置，直到它在医疗设备中打开。
虽然已通过多种实施方式和方法的描述对本发明进行了说明，但本发明的申请人并不是想将所附的权利要求书的精神和范围限制得如此详细。许多改变、变化和替代可在不背离本发明的精神的前提下由本领域技术人员进行。此外，与本发明相关的每个元件能够替代地描述为用于提供由该元件所执行功能的装置。由此，意图在于仅通过所附权利要求的精神和范围来限制本发明。

Claims (12)

1.一种超声外科器械，包括：
具有近端和远端的外壳；
具有近端的外部护罩，所述外部护罩的近端连接到所述外壳的远端，所述外部护罩限定有纵向轴线；
位于所述外部护罩上的至少一个凸轮槽；
定位在所述外部护罩中的超声波导管，所述波导管具有近端、远端和超声致动的刀，所述超声致动的刀定位在所述波导管的远端处；
致动杆，所述致动杆具有近端、远端和至少一个凸轮构件，所述致动杆限定第一开口，所述第一开口用于接收所述外部护罩；以及
位于所述致动杆的远端处的夹钳垫，其中所述至少一个凸轮构件可操作地接合所述至少一个凸轮槽，所述致动杆的运动使所述夹钳垫相对于所述刀在打开位置和夹钳位置之间定位。
2.根据权利要求1所述的超声外科器械，其中，所述外部护罩包括多个凸轮槽。
3.根据权利要求1所述的超声外科器械，其中，所述凸轮构件是圆柱形的。
4.根据权利要求1所述的超声外科器械，其中，所述凸轮构件是球形的。
5.根据权利要求1所述的超声外科器械，其中，所述至少一个凸轮槽的一部分包含弹性体插入物。
6.根据权利要求1所述的超声外科器械，其中，所述致动杆的近端限定第二开口。
7.根据权利要求1所述的超声外科器械，其中，所述外壳具有腔。
8.根据权利要求7所述的超声外科器械，其中，所述腔接收换能器，以便可拆卸地连接到所述波导管。
9.根据权利要求8所述的超声外科器械，其中，所述第二开口限定长度L，并且所述长度L在所述外壳上限定相应的长度，所述外壳和换能器的尺寸能够用于将所述超声外科器械在所述外壳处的重心定位在所述相应长度内。
10.根据权利要求8所述的超声外科器械，其中，所述长度L平行于所述纵向轴线。
11.根据权利要求1所述的超声外科器械，还包括定位在所述外壳上的第一开关，用于通过使用者的一个或多个手指沿与所述纵向轴线平行的方向进行启动，用于向发生器提供电信号，以控制由连接到所述波导管的换能器传递的超声能量的第一水平。
12.根据权利要求11所述的超声外科器械，还包括定位在所述外壳上的第二开关，用于通过使用者的一个或多个手指沿与所述纵向轴线平行的方向进行启动，用于向所述发生器提供电信号，以控制由所述换能器传递的超声能量的第二水平。
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