CN101491447B - 超声外科器械 - Google Patents

超声外科器械 Download PDF

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CN101491447B
CN101491447B CN2009100045389A CN200910004538A CN101491447B CN 101491447 B CN101491447 B CN 101491447B CN 2009100045389 A CN2009100045389 A CN 2009100045389A CN 200910004538 A CN200910004538 A CN 200910004538A CN 101491447 B CN101491447 B CN 101491447B
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ultrasonic
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CN101491447A (zh
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R·D·福特森
J·E·扬
D·A·威特
W·D·丹纳尔
J·A·威德三世
T·A·亚当斯
S·A·诺斯查恩格
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Ethicon Endo Surgery Inc
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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B25—HAND TOOLS; PORTABLE POWER-DRIVEN TOOLS; MANIPULATORS
    • B25B—TOOLS OR BENCH DEVICES NOT OTHERWISE PROVIDED FOR, FOR FASTENING, CONNECTING, DISENGAGING OR HOLDING
    • B25B23/00—Details of, or accessories for, spanners, wrenches, screwdrivers
    • B25B23/14—Arrangement of torque limiters or torque indicators in wrenches or screwdrivers
    • B25B23/142—Arrangement of torque limiters or torque indicators in wrenches or screwdrivers specially adapted for hand operated wrenches or screwdrivers
    • G—PHYSICS
    • G10—MUSICAL INSTRUMENTS; ACOUSTICS
    • G10K—SOUND-PRODUCING DEVICES; METHODS OR DEVICES FOR PROTECTING AGAINST, OR FOR DAMPING, NOISE OR OTHER ACOUSTIC WAVES IN GENERAL; ACOUSTICS NOT OTHERWISE PROVIDED FOR
    • G10K11/00—Methods or devices for transmitting, conducting or directing sound in general; Methods or devices for protecting against, or for damping, noise or other acoustic waves in general
    • G10K11/18—Methods or devices for transmitting, conducting or directing sound
    • G10K11/24—Methods or devices for transmitting, conducting or directing sound for conducting sound through solid bodies, e.g. wires
    • 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
    • A61B2017/2825—Inserts of different material in jaws
    • 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
    • A61B2017/320071—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with articulating means for working tip
    • 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
    • A61B2017/320089—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic node location
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/03—Automatic limiting or abutting means, e.g. for safety
    • A61B2090/031—Automatic limiting or abutting means, e.g. for safety torque limiting
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/03—Automatic limiting or abutting means, e.g. for safety
    • A61B2090/033—Abutting means, stops, e.g. abutting on tissue or skin

Abstract

本发明涉及一种超声外科器械，更具体地说是一种超声外科波导，该超声外科波导具有近侧部分和远侧部分，所述远侧部分包括超声外科刀主体，所述刀主体具有远侧尖端，该尖端是最远侧的振动腹点；其中，所述远侧部分包括大于单位增益的第一增益台阶和大于单位增益的第二增益台阶。

Description

超声外科器械
本申请是申请日为2007年5月29日、国际申请号为：PCT/US2007/069842、国家申请号为：200780025918.X、名称为“超声外科器械”的进入中国国家阶段的国际申请的分案申请。
相关申请的引用
本申请要求2006年6月1日提交的序列号为No.60/809971的美国临时专利申请的优先权。
技术领域
本发明总的涉及超声外科器械，更具体地，本发明涉及一种超声外科波导。
背景技术
本申请包括涉及以下非临时申请的主题，出于任何和全部的目的，这些非临时申请的全部内容通过引用结合入本申请：
专利号为No.7163548的美国专利：ULTRASONIC SURGICALBLADE AND INSTRUMENT HAVING A GAIN STEP；
2005年10月7日提交的序列号为No.11/245819的美国专利申请：TISSUE PAD FOR USE WITH AN ULTRASONIC SURGICALINSTRUMENT；
2005年10月7日提交的序列号为No.11/246794的美国专利申请：COMBINATION TISSUE PAD FOR USE WITH ANULTRASONIC SURGICAL INSTRUMENT；
2005年10月7日提交的序列号为No.11/246826的美国专利申请：ACTUATION MECHANISM FOR USE WITH AN ULTRASONICSURGICAL INSTRUMENT；
2005年10月7日提交的序列号为No.11/246264的美国专利申请：CLAMP MECHANISM FOR USE WITH AN ULTRASONICSURGICAL INSTRUMENT；
2005年10月7日提交的序列号为No.11/246384的美国专利申请：FEEDBACK MECHANISM FOR USE WITH AN ULTRASONICSURGICAL INSTRUMENT；
2005年10月7日提交的序列号为No.11/246330的美国专利申请：HANDLE AS SEMBLY HAVING HAND ACTIVATION FOR USEWITH AN ULTRASONIC SURGICAL INSTRUMENT；
2005年2月24日提交的序列号为No.11/065378的美国专利申请：ULTRASONIC SURGICAL SHEARS AND TIS SUE PAD FORTHE SAME；和
2004年6月16日提交的序列号为No.10/869351的美国专利申请：HAND ACTIVATED ULTRASONIC INSTRUMENT。
另外，本申请与下列同时提交的美国专利申请具有共同的说明书：ULTRASONIC WAVEGUIDE AND BLADE，序列号[代理卷号No.END5881USNP1]；ULTRASONIC BLADE SUPPORT，序列号[代理卷号No.END5881USNP2]；以及MECHANISM FOR ASSEMBLYOF ULTRASONIC INSTRUMENT，序列号[代理卷号No.END5881USNP3]。
超声外科器械由于其独特的性能特点被越来越广泛地应用于外科手术中。根据具体的器械结构和操作参数，超声外科器械能够基本上同时切割组织并通过凝结止血，从而如期望地使对患者的损伤最小化。切割动作通常是通过位于所述器械远端的端部执行器或刀的尖端将超声能量传递至与端部执行器接触的组织来实现的。这种特性的超声器械可以被构造用于开放式外科手术、腹腔镜手术或者内窥镜手术，包括机器人辅助的手术。
已经开发出了包括夹钳机构的超声外科器械，夹钳机构将组织压靠在端部执行器的刀上以向患者的组织传递超声能量。美国专利No.5322055、No.5873873和No.6325811中公开了这样的设计(有时称作夹钳凝结器剪刀或超声横切器)，这些专利的内容通过引用结合入本文。外科医生通过挤压手持件或者手柄来致动夹钳臂，以使夹钳垫压靠刀。
然而，目前的一些超声剪刀装置容易产生组织残留物。组织残留物是在钳口中的大部分组织被横切掉并脱落后仍夹钳在钳口中的那些没有被横切掉的组织。组织残留物可能是由于对端部执行器或者刀的尖端的近侧加载不充分和/或刀近侧的活动性较低。外科医生可以或者通过增加竖直张力(即使用刀在组织上作用张力)，或者通过向装置施加向后牵引力而使未被横切掉的组织运动到刀活动性更高的部分以完成切割，从而减少组织残留物。
目前的一些超声剪刀装置采用与刀表面平行地闭合的组织垫。这使施加到组织上的压力分布出现了一些问题。随着组织被压在钳口和刀之间，刀的远侧部分在负载的作用下要比刀的近侧部分偏转得更多。这种偏转部分是由刀在装置的最远侧节点的远侧的部分产生的，还部分是由最远侧节点近侧的波导或者传动杆的偏转产生的。另外，由于即使在压力恒定时，传递到组织的能量也是减小的，因此，刀的振幅随着靠近刀的尖端近侧而减小的事实使情况变得更糟。
目前的组织垫设计采用PTFE(聚四氟乙烯)材料来接触组织和刀。尽管这些设计还算可以，但由于这些垫容易在长时间的外科手术中损坏，因此它们具有寿命不长的问题。此外，较新的夹钳凝结器剪刀设计增加了刀的振幅和/或垫对组织和刀的载荷，并由此破坏垫材料，导致组织垫的寿命低于所需寿命。垫的材料限制了可以施加到组织和刀上的力的大小，而力的大小又限制了一些目前的夹钳凝结器剪刀可以有效切割和凝结的组织厚度或者脉管尺寸。目前的合成垫可能难以制造或者制造起来非常昂贵。
由于目前的一些夹钳凝结器剪刀设计具有沿着刀的纵向路径从换能器组件有效传递机械运动的内在限制，因而这些设计受到医生可用的有效刀长度的限制。尽管新刀的几何特性可以消除其中的一些问题，但更长的有效刀长度，或者质量更大的刀(通过更大的直径或者更长的长度形成)容易使共振和防共振频率之间的频率范围缩小，从而使超声发生器很难或者不可能锁定在合适的频率以驱动波导、刀和换能器组件。
目前的一些夹钳凝结器剪刀设计采用诸如硅树脂等弹性体材料作为沿着刀长度的节点支撑件。最远侧节点支撑件通常是硅树脂的，其提供围绕刀的密封。当需要更大的夹钳力时，如具有较长的有效刀长度的情形，需要具有刚性的远侧节点支撑件。但是，刚性节点支撑件具有很多固有问题。能够经受住超声刀节点支撑件的压力和温度要求的材料，例如热固性聚合物，常常过于昂贵，因此不能在制造中采用。使用热塑性材料能够从成本方面提高可制造性，但又可能不能满足超声刀节点支撑件的压力和温度要求。
目前的一些夹钳凝结器剪刀设计采用能够防止向夹钳臂和刀施加过大力的恒力弹簧机构。尽管所述机构向系统提供相对恒定的力，但是弹簧造成力曲线具有斜率。在夹钳力很低的应用中，所述斜率不是很明显。但是在夹钳力很大的应用中，由弹簧压缩的可能范围内的斜率引起的力差变得非常明显并且可能超过刀、管组件或者系统的其它部件允许的最大力。大的斜率在误用模式下或者通过正常的制造公差变化可能使得力超过最大力。一旦发生了这种情况，刀可能弯曲，致动机构可能失效或者发生不希望的组织效果(即快速切割，但组织凝结最小)。当夹钳垫快要接触到刀(当横切薄的组织或者在横切结束时或者夹钳诸如其它装置等固定物体时)或者夹钳臂相对于刀仍然打开时(当横切厚的组织时)，由于装置的钳口(夹钳臂和垫)接合力限制机构遇到很大的阻力，该事实使上述情形更加恶化。
目前的一些夹钳凝结器剪刀设计采用力限制弹簧来确保夹钳力处于特定的范围。力限制弹簧设计也需要允许医生“慢慢增加力”(施加小于最大力的力并慢慢增加到最大力)。因此，在这些机构中，直到达到预定的力钳口才闭合，然后另外的冲程驱动所述机构进入力限制范围。但是，在一些情形中医生可能毫无察觉地没能将钳口的全部力施加到组织上，造成组织切割不完全或者凝结不充分。替代地，医生可能在横切过程中在不经意的情况下打开夹钳臂，造成组织切割不完全或者凝结不充分。
目前的一些夹钳凝结器剪刀设计采用脚踏板来为外科器械供应能量。医生在向手柄上施加压力以将组织压在钳口和刀之间的同时操作脚踏板，以致动提供能量的发生器，所述能量被传递给切割刀用于切割和凝结组织。这类器械致动的致命缺陷包括在医生寻找脚踏板时会分散医生在手术部位上的注意力，脚踏板妨碍了医生在手术过程中进行运动并且在长的手术过程中医生的腿容易疲劳。
目前的一些用于超声外科器械的扭矩扳手设计采用多件式扭矩扳手，用于适当地将器械扭到超声手持件。多件式组件需要分开单件模制然后组装，因而成本更高。另外，多件式容易很快磨损从而导致扳手失效。
因此，需要提供一种超声外科器械，其能够克服目前的器械的一些缺陷。此处描述的超声外科器械能够克服这些缺陷。
发明内容
本发明满足了用于超声外科器械的改进的组织垫的上述需求。提供一种用于超声夹钳凝结器的组织垫，该组织垫包括：i)第一组织垫部分，该第一组织垫部分具有远端，近端，组织接合表面，和腔，该腔具有与所述组织接合表面一致的开口；和ii)第二组织垫部分，该第二组织垫部分由耐热性高于第一组织垫部分的组合物制成，所述第二组织垫部分具有组织接合表面，并且第二组织垫部分的尺寸能够布置在所述腔内。
一种用于将第一组织垫部分安装到超声夹钳凝结器的夹钳臂上的方法，包括如下步骤：i)将所述第一组织垫部分插入到夹钳臂中，在插入过程中将所述第一组织垫部分定位成使得所述腔位于所述臂的近侧部分，和ii)将由耐热性高于第一组织垫部分的组合物制成的第二组织垫部分插入到所述腔中，所述第二组织垫部分具有组织接合表面且该第二组织垫部分的尺寸能够布置在所述腔内。
本发明满足了对具有更大波振幅和具有更长有效刀长度且仍有充分的频率余量或频率范围的波导和刀的上述需求。波导具有设置在波导的远侧部分的一系列增益台阶，增益台阶优选设置在相对于手持件的最远侧的两个节点，或者相对于刀尖端最近侧的两个节点处。
本发明满足了对能够使沿着更长的有效刀长度提供更大的夹钳力的波导支撑件的上述需求。该波导由设置在波导和外部护套之间的刚性支撑件支撑。所述支撑件优选是内径与波导的外径一致、外径与外部护套的内径一致的环形轴衬。在该实施方式的第二种形式中，所述支撑件具有用于连接到外部护套的支柱，该支柱还将热量从波导引导到外部护套。
一种用于向超声外科器械提供节点支撑的方法，所述超声外科器械包括外部护套和设置在所述外部护套内的波导，并具有远侧的刀和最远侧振动节点，所述步骤包括：a)提供包括环形轴衬的刚性节点支撑件；b)将所述刚性的环形轴衬设置在所述波导和外部护套之间；c)提供连接到所述环形轴衬的至少一个支撑构件；d)将所述至少一个支撑构件设置成与所述外部护套接触；和e)将所述环形轴衬设置在所述最远侧振动节点处。
本发明满足了对用于超声外科器械的一件式扭矩扳手的上述需求。所述扭矩扳手包括绕扭矩扳手的中心线以环状方式对齐的悬臂。所述悬臂包括相对于悬臂垂直向内的齿。所述外科器械包括外管保持器，外管保持器包括沿着保持器的外周垂直突出的花键齿轮。扭矩由所述悬臂传递到花键齿轮，以用于将手持件连接到夹钳凝结器。
附图说明
本发明的新颖特征特别在所附的权利要求中阐述。然而，本发明本身(其结构及其操作方法)可通过参考结合附图的以下说明更好地得到理解，其中：
图1是示出了根据本发明的超声外科器械的一种实施方式的平面图；
图2是根据本发明的超声外科器械的一种实施方式的立体组装图；
图3是根据本发明的波导和刀组件的一种实施方式的俯视图；
图3a是根据本发明的刀组件的远端的一种实施方式的截面视图；
图3b是根据本发明的波导和刀组件及硅树脂支撑环的一种实施方式的俯视图；
图3c是描绘出沿着本发明的一种实施方式的波导和刀的长度的波形曲线；
图3d是刀远侧的节点支撑件的一种实施方式的立体图、侧视图和截面图；
图4a示出了本发明的一种实施方式的外部护套和夹钳臂组件的俯视图、侧视图和截面图；
图4b是本发明的夹钳臂和夹钳垫组件的一种实施方式的立体组装图；
图4c是本发明的夹钳臂的一种实施方式的侧视图和截面图；
图4d是本发明的组织垫插入件的一种实施方式的立体图；
图5是本发明的外管的一种实施方式的俯视图和侧视图；
图6是本发明的内管的一种实施方式的侧视图和俯视图；
图7是手持件组件的远端和电环接触器的立体组装图；
图8a是本发明的一种实施方式的连接器和柔性板组件的前侧和后侧的立体视图；
图8b是本发明的一种实施方式的摇臂式开关的俯视图；
图8c是开关电路的电路图；
图9是根据本发明用医生的左手抓握的超声外科器械的平面图，其中食指接触第一致动按钮；
图10是根据本发明用医生的右手抓握的超声外科器械的平面图，其中食指接触第一致动按钮；
图11是扭矩扳手的一种实施方式的立体图、侧视图和截面端视图；
图12是本发明的外管保持器的一种实施方式的立体图和截面端视图；
图13是示出了作为扳机位置的函数的各个力的力曲线。
具体实施方式
在详细解释本发明之前，应当注意，本发明不限于附图和说明书中所示和阐述的部件的结构和设置的细节的应用和用途。本发明所示的实施方式可以实现或结合入其它实施方式、变形和改变中，并且可以以各种方式实践或执行。另外，除非另外指明，这里采用的术语和表述形式均是出于方便读者而对本发明的所示实施方式进行描述的目的加以选择的，而不是为了限制本发明。
另外，应当理解，下述实施方式、实施方式的表述形式、例子等中的任何一个或多个能够与下述其他的实施方式、实施方式的表述形式、例子等中的任何一个或多个结合。
本发明尤其涉及改进的超声外科夹钳凝结器设备，其被构造用于在外科手术过程中实现组织的切割、凝结和/或夹钳。本发明的设备易于被构造用于开放式外科手术，以及腹腔镜手术或者内窥镜手术和机器人辅助的外科手术。超声能量的选择使用为多种应用提供了便利。当设备的超声组件未被激活时，可以根据需要很容易地抓握并操作组织，而不切割或损坏组织。当所述超声组件被激活时，所述设备能够抓握组织用于传递超声能量以实现组织凝结，并且施加增大的压力以有效地实现组织切割和凝结。如果需要，可以通过适当地操作超声刀向组织施加超声能量，而不需使用设备的夹钳机构。
如从下面的描述可以清楚看到的，本发明的夹钳凝结器设备由于其结构简单尤其被构造用于一次性使用。这样，可以设想所述设备与超声发生器单元和外科系统的换能器结合使用，由此，来自发生器单元的超声能量通过换能器为当前的夹钳凝结器设备提供所需的超声致动。应当理解，体现本发明的原理的夹钳凝结器设备能够被构造成非一次性或者多次使用，并且与相关的手持件(或者换能器)单元不可拆卸地形成为一体。然而，对于单个患者使用该设备来说，本发明的夹钳凝结器设备与相关的超声手持件的可拆卸连接目前是优选的。
现在结合此处所述的超声器械对本发明进行描述。这种描述仅是示例性的，并不意在限定本发明的范围和应用。例如，本发明可以结合很多超声器械使用，例如包括在美国专利No.5938633；No.5935144；No.5944737；No.5322055；No.5630420和No.5449370中描述的那些超声器械。
参考图1至图3，图中示出了外科系统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包括超声外科器械100和借助电缆22连接到超声换能器50上的超声发生器30。应当注意，在一些应用中，超声换能器50被称为“手持件组件”或者简单地称为“手持件”，因为外科系统19的外科器械被构造成在各种手术和操作过程中医生可以抓握并操纵的超声换能器50。一种合适的发生器是美国俄亥俄州辛辛那提的EthiconEndo-Surgery，Inc.(伊西康内外科公司)出售的GEN300TM。
超声外科器械100包括多件式手柄70，手柄70适于将操作者与容纳在换能器50内的声学组件的振动隔离。手柄70的形状可以形成为能够使使用者以传统的方式握持，但是可以设想，本发明的超声外科器械100原则上通过如下所述的器械的手柄组件提供的剪刀状设置来抓握并操作。尽管示出了多件式手柄组件70，但手柄70可以包括单个或一体式的组件。通过将超声换能器50插入到手柄70中，超声外科器械100的近端接收并配合到超声换能器50的远端。超声外科器械100可以作为一个单元相对于超声换能器50进行拆装。
现在具体参考图2，超声外科器械100可以包括手柄组件70和传输组件71，手柄组件70包括配合的壳体部分68和69，壳体部分68和69合起来形成手柄70。超声外科器械100能够应用于开放式外科手术和内窥镜外科手术中。该结构的尺寸可以设置成使得传输组件71的外径为大约8.5mm。超声外科器械100的细长传输组件71从器械的手柄70垂直地延伸。手柄70可以由耐用塑性材料构成，例如聚碳酸酯或者液晶聚合物。还可以想到，手柄70可以选择地由包括其它塑性材料、陶瓷或者金属的各种材料制成。
传输组件71可以包括管状的外部构件或者外部护套72，管状的内部致动构件76，波导80和端部执行器81(刀79、夹钳臂56、销56b和一个或多个夹钳垫58)。如下所述，外部护套72、致动构件76和波导或者传输杆80可以连接在一起以便相对于手柄70作为一个单元(与超声换能器50一起)转动。波导80适于将超声能量从换能器50传递到刀79，该波导80可以是柔性的、半柔性的或者是刚性的。
超声波导80还可以包括至少一个径向孔或者孔口66，该孔口66延伸穿过波导80延伸并基本垂直于波导80的纵向轴线。孔口66可以定位在节点处，并被构造成容纳绝缘的连接销27，连接销27将波导80连接到管状致动构件76、管状外部护套72以及外部管保持器29上。如本领域已知并理解的，可以增加旋转旋钮28(未示出)或者用旋转旋钮来替代保持器29，以有助于刀组件80、包括端部执行器81相对于器械手柄70进行旋转。
刀79可以与波导80结合并形成为一个单个单元。在目前的实施方式的一种替代形式中，可以用螺纹连接、焊接或者其它联接机构将刀79连接到波导80上。刀79的远端靠近腹点设置以便于在声学组件没有被组织加载时将声学组件调整到优选的共振频率fo。当超声换能器50被供能时，刀79的远端被构造成在例如预定振动频率fo例如为55500Hz，峰峰值大约在10到500微米、优选在大约20到大约200微米的范围中纵向运动。
现在参考图3，波导80还可以被构造成如本领域已知的放大通过波导80传输到刀79的机械振动，这在2003年11月5日提交的序列号为No.10/701558、专利号为No.7163548B2的题为“ULTRASONIC SURGICAL BLADE AND INSTRUMENT HAVINGA GAIN STEP”的美国专利文献中有全面的描述，该文献通过引用结合入本文。在本发明的一种实施方式中，波导80还具有控制沿波导80的纵向振动的增益的部件和将波导80调节到系统的共振频率的部件。具体来说，波导80可以具有任何合适的横截面尺寸。例如，波导80可以具有大致相同的横截面或者波导80在不同的部分变细或者如此处详细描述的沿着其整个长度变细。
在本发明的一种实施方式中，波导80包括位于最远侧振动节点和刀79的远侧尖端79a的中空膛孔101。如本领域中已知并理解的，本实施方式中的该中空膛孔101通过伸展或者扩张波长而使得刀的有效长度更长。该更长的有效刀长度需要更大直径的刀79以便形成膛孔。为了确保刀79的适当性能并实现刀所需的切割和凝结动作，可以使用更大的波的振幅。有效刀长度的增加和波振幅的增加可能造成系统难以实现共振。例如，已调节好共振频率为55500Hz的具有中空膛孔刀的系统，可能在55500Hz时实现防共振。该窄频率范围可能使发生器30(见图1)难以或者不可能在其共振频率持续地驱动波导80和刀79。
为了使波的振幅更大、刀的有效长度更长且仍然能够提供充分的频率余量或者范围，在波导80内设有一系列增益台阶。增益台阶的增益由于节点处的超声波导的质量的增加而小于单位增益，并且增益台阶的增益由于节点处的超声波导的质量的减少而大于单位增益。增益部件是在节点处增加或者减少波导或者刀的质量的波导或者刀的任何一个几何结构并包括：外径或周长、斜面、纵向孔、横向孔、孔穴、表面的平坦部、表面狭槽的离散变化和材料的改变。术语“孔”包括通孔和非通孔。技术人员可以想到其它的增益部件。
在本发明的一种实施方式中，增益台阶102位于第二远侧振动节点处(见图3)，并设置在波导80中。如本领域中已知并理解的，增益台阶102减小了刀的横截面积，从而使在减小的直径中获得更大的波振幅。为了便于获得更长的有效刀长度并保持所需的刀直径，在腹点处或其附近设有增大台阶103，其增加了波导80的横截面积，却不会影响增益。在一种实施方式中，增大台阶103位于相对于刀远侧的尖端79a的第二远侧振动腹点处。刀79的附近设置有第二减小台阶或者增益台阶104。第二增益台阶104引起第二次振幅增加。在一种实施方式中，第二增益台阶104位于相对于刀尖端79a第一最远侧振动节点处。
如本领域中已知和理解的，在超声刀系统中，发生器产生电流以驱动位于手持件50内的换能器。该换能器以特定的频率将机械能传递给波导及与波导连接的刀。在使频率变化以试图找到系统的共振频率并以该共振频率驱动系统时，发生器持续传递电能以转化成机械能。将换能器和波导等同为一个相当的电动模型，随着循环的频率的增加，从低于所需的共振频率的非共振频率开始，系统的振动首先达到一个阻抗最小(导纳最大)的频率处。该最小阻抗频率接近串联共振频率，在该串联共振频率处，运行所述元件的电路中的阻抗为零(假定忽略由机械损失引起的阻抗)。该最小阻抗频率也是波导和刀组件的共振频率，其设计成在标称上与换能器的共振频率相同。换能器的材料组成和波导以及刀组件的形状和体积合起来确定了共振频率。随着循环频率进一步减小，阻抗增加到最大值(即导纳最小)。最大阻抗频率接近并联共振频率，在该并联共振频率处，在等同电路中的并联电阻无穷大(假定忽略由机械损失引起的阻抗)。该最大阻抗频率也是防共振频率。共振频率和防共振频率之间的差(即频率范围或者相余量)越大，发生器就越容易在波导和刀组件中建立并保持共振，这是由于放宽了频率容限。
在本发明中，上述的增益台阶可能造成严重的声阻抗不匹配，引起沿着波导传输的一些机械能发生偏移(reflect)。如图3和图3c所示，波振幅的增益是由波导80中的与增益台阶102相邻的较薄横截面引起的。在增益台阶102处，厚度的变化导致台阶102后防共振频率降低。这使得共振和防共振之间的频率范围更窄或者其间的波谷更陡。增大台阶103引起波导横截面或者厚度的增加，这部分解决了制造要求。
申请人已经确认，将增益台阶定位在波导的远侧部分会使得相余量更大或者共振频率和防共振频率之间的波谷更宽。“远侧部分”意为波导的远侧一半。通过推迟波导向其远端变窄，可以沿着波导储存更多的机械能并且减轻了由增益台阶处的偏移带来的任何负面影响。应当理解，增益台阶或者增大/减小/增大台阶的组合可以位于沿波导的任何位置。但是为了获得理想的系统性能，增益台阶应当位于刀的远侧一半，优选位于相对于手持件最远侧的两个节点处，或者相对于刀尖端最近侧的两个节点处。意外的结果是，申请人发现通过将增益台阶重新定位在波导的远侧部分，相余量几乎增加了100％。在早期的实验中，波导具有两个增益台阶，一个在近端，一个在远端，测定的相余量为30Hz到40Hz。在波导具有两个增益台阶且都位于远侧部分的实验中，测定的相余量在50Hz和80Hz之间。在波导具有两个增益台阶且分别位于两个最远侧的节点处的实验中，测定的相余量在75Hz和80Hz之间。
在另一种实施方式中(未示出)，单个增益台阶位于相对于刀的尖端79a第一最远侧或者第二最远侧的节点处。单个增益台阶不需要位于刀上的增大台阶和减小台阶。为了容纳中空尖端的刀，波导80必须具有足够大的横截面以将波从手持件传输到第一增益台阶102，并且波导和刀的直径差必须足够大以从减小台阶、增大台阶和减小台阶的组合获得波振幅增益。该直径差必须足够大以获得正确的刀的纵向偏移并且提供用于将系统锁定在共振的足够大的频率范围。
再次参考图3，图中示出了波导80和刀79的组合。在一种实施方式中，所述组合的总长度为8.854英寸。第一增益台阶102位于与近端90距6.139英寸处。增大台阶103位于与近端90距6.922英寸处。第二增益台阶104位于与近端90距7.912英寸处。膛孔101从刀尖端79a测量起为0.384英寸。
现在参考图3c，图表91示出了波振幅与刀的距离和几何形状的关系的曲线。y轴代表以最大位移的百分数给出的波振幅。x轴代表刀长度。波92代表由参考图3讨论的波导80和刀79的横截面变化引起的沿着其长度的响应或者增益。波92与x轴相交的点称作节点或者振动节点。波92到达最大振幅的点称为腹点。可以看到，波振幅92中的第一增益与增益台阶102对应，波振幅92中的第二增益发生在第二增益台阶104处。
参考图3b，波导80可以具有多个稳定硅树脂环80a或覆盖支撑件，以阻止波导80在激活的过程中与内管76接触。如本领域已知并理解的，硅树脂环80a理想地位于波导80上的节点处。环80a优选在波导80上模制而成以保证准确定位。在最远侧的节点处，即最靠近端部执行器81处，可以设置密封件以中断波导80和致动构件76之间的区域中的组织、血液和其他材料的通过。在本发明的该实施方式中，硅树脂环可以不完全在波导80的最远侧节点处。如上所述，波导80设有将传输到刀79的波放大的多个增益台阶102和104。刀的最大偏移发生在刀尖端79a处。为了便于在刀79的近侧部分中的组织切割，优选采用比硅树脂刚度更大的节点支撑件(“刚性”支撑件)以促进波传递到刀，从而防止波被吸收或者损失，并进一步使刀相对于夹钳臂56的偏移尺寸更加精确和稳定。由于刚性支撑件不会像硅树脂等材料那样在较高的夹钳力下压缩或屈服，因而刚性支撑件能够用于使刀79的近侧部分中具有较高的夹钳力。
参考图2和图3d，图中示出了刀支撑件450。在第一实施方式的第一种形式中，支撑件450为两件式。优选由热固性聚合物制成的套筒451绕环形开口452布置。该套筒可以由例如VESPEL(聚氨酯树脂)211的棒料树脂构成。然后将套筒451嵌件模制或压制到由比较便宜的热塑性树脂制成的轴衬453中。轴衬453优选由具有高导热性的填充热塑性树脂组成，例如填充聚醚醚酮。在这种两件式构造中，支撑件450能够经受与超声刀79和波导80的操作有关的温度和压力。在操作中，当刀被激发时，刀中积累的热量通过热固性树脂插入件451传递给轴衬453。轴衬453将热量传递给翅片454。翅片或者支撑件454将轴衬453支撑在外部管或者护套72中并且也将热量从轴衬453和插入件451传递到刀79和致动构件76之间的空隙中。在第一实施方式的第二种形式中，刀支撑件450由结构均一的热塑性树脂构成，例如聚醚醚酮。在第一实施方式的第三种形式中，刀支撑件450由结构均一的热固性树脂或者高温注射模制的聚酰胺或者结构均一的压模材料制成。本领域的技术人员也可以想到用于刀支撑件450的其它材料，例如陶瓷和金属。
超声换能器50和超声波导80一起提供了本发明的外科系统19的超声组件，当由发生器30供能时该超声组件提供用于外科手术的超声能量。外科器械100的超声组件通常包括第一超声部分和第二超声部分。在本实施方式中，第一超声部分包括超声换能器50的超声活动部分，并且第二超声部分包括传输组件71的超声活动部分。另外，在本实施方式中，第一超声部分的远端例如通过螺纹连接件可操作地连接到第二超声部分的近端。
具体参考图2、图9和图10，致动构件76的往复运动驱使夹钳构件60打开和关闭。力限制机构95可操作地连接到致动构件76并包括将远侧垫圈97、波形弹簧94固定到螺纹轴衬盖93上的管状轴衬98。外部管状保持器29借助绝缘销27与管状致动构件76的近侧部分中的开口75接合。管状轴衬98上的肩部74容纳用于与外部护套72的内表面接合的驱动轭状件33。
力限制机构95提供了器械100的一部分夹钳驱动机构，其通过致动构件76的往复运动影响夹钳构件60的枢转运动。夹钳驱动机构还包括与器械的操作扳机手柄34可操作地连接的驱动轭状件33，由此，操作扳机手柄34借助驱动轭状件33和力限制机构91与可往复的致动构件76相互连接。扳机手柄34借助销35和36连接到驱动轭状件33和连杆37上。弹簧12位于驱动轭状件33和手柄组件68和69之间，将可往复运动的致动构件76偏压到打开位置。
扳机手柄34朝手持件70的运动使致动构件76向近侧移动，从而使夹钳构件60朝刀79枢转。通过扳机手柄34和操作手持件70提供的类似剪刀的动作便于方便和高效地操作并定位器械，并且便于在器械的远侧部分处操作夹钳机构使得组织高效地压靠在刀79上。扳机手柄34远离手持件70的运动使致动构件76向远侧移动，从而使夹钳构件60枢转远离刀79。
具体参考图4a，图中示出了用于本发明的超声外科器械100的夹钳构件60的一种实施方式，该夹钳构件60被构造用于与刀79(未示出)配合动作。夹钳构件60和刀79合起来通常被称为端部执行器81，夹钳构件60通常被称为钳口。夹钳构件60包括可枢转地运动的夹钳臂56，夹钳臂56与组织接合垫或者夹钳垫58一起连接到外部护套72的远端和致动构件76(未示出)。在本实施方式的一种形式中，夹钳垫58由E.I.Du Pont de Nemours and Company的商标名为特氟隆
Figure G2009100045389D00161
(特氟隆)的材料制成，这种材料是低摩擦系数的聚合物材料，或者也可由任何其它合适的低摩擦系数材料制成。夹钳垫58安装在夹钳臂56上，用于与刀79配合，夹钳臂56的枢转运动将夹钳垫定位成与刀79基本平行并与刀79接触，由此限定组织处理区域。通过这种结构，组织被抓握在夹钳垫58和刀79之间。如所示的，夹钳垫58可以设有不平滑的表面(例如锯齿状结构)，以与刀79配合提高对组织的抓握。锯齿状结构或者齿能够提供抵抗刀运动的牵拉。齿还可以对刀和夹钳运动提供相反的牵拉。如本领域的技术人员可以理解的，锯齿状结构仅是阻止组织相对于刀79运动的多种组织接合表面中的一种示例。其它示例性的例子包括凸块、交叉形图案、胎面花纹、喷丸或者喷沙处理的表面等。
具有合成结构的组织垫虽然相比特氟隆垫具有好处和优点，但是却有成本和制造方面的不足。合成组织垫典型地压模成平的样片。这种压模可能很耗时且成本较高。制成平的样片后，必须将其加工成适合用于与夹钳超声装置一起使用的组织垫，这进一步增加了制造工艺的时间和成本。
具体参考图4a和4b，本实施方式的第一种形式包括夹钳垫58，该夹钳垫具有近侧部分58b和远侧部分58a并包括锯齿状结构。夹钳垫58可以是单个部件，具有环形开口58c。环形开口58c被构造来接收垫插入件58d。两个单独部件58和58d的好处在于垫和插入件可以由不同的材料制成。例如，两件式组织垫允许在远端使用与近端使用的温度很高但不是特别润滑的材料相比来说非常润滑但不是特别能经受高温的材料，因为近端是低振幅的区域。这种结构使组织垫材料与刀79的振幅相匹配。申请人发现，在一个实验中，填充有15％石墨、30％聚四氟乙烯(PTFE)的聚酰亚胺组织垫在4.5磅的夹钳力下，具有与100％的PTFE组织垫在1.5磅夹钳力下基本相同的耐磨性或耐磨性更好。填充有15％石墨、30％PTFE的聚酰亚胺组织垫的好处在于提高的耐热性，这改善了组织垫的整体耐磨性。这种石墨合成夹钳垫的有用的耐热性最高为大约800至大约1200，而PTFE夹钳垫的有用的耐热性最高为大约660。替代地，其他材料也可以用于组织垫的一部分(即元件58d)，例如陶瓷、金属、玻璃和石墨。
在本实施方式的一种替代形式中，夹钳垫58包括比远侧部分58a(未示出)更平滑的近侧部分58b，其中，远侧部分58a包括锯齿状结构。近侧部分58b可以不采用锯齿状齿或者设想其它组织接合表面。在夹钳垫58上使用平滑的近侧部分58b允许近侧区域中的组织向远侧运动，随着刀的振动动作，允许组织运动到刀79的更加有效的区域，以防止组织残留。这种概念利用了刀79的固有运动轮廓。由于正弦运动，运动的最大位移或振幅位于刀79的最远侧部分，而组织处理区域的近侧部分的振幅处于远侧尖端的振幅的50％的等级上。在操作过程中，端部执行器的近侧区域(部分58b的区域)中的组织会脱水并变薄，并且端部执行器81的远侧部分将横切该远侧区域中的组织，由此允许近侧区域内的脱水和薄的组织向远侧滑动到端部执行器81的更加有效的区域中，以完成组织横切。
在本发明的此实施方式的另一种形式中，夹钳垫58a由特氟隆或者任何其它合适的低摩擦系数材料制成。垫插入件58d由合成材料，例如聚酰亚胺制成。
在本发明的一种实施方式的一种形式中，垫插入件58d由圆柱形的合成材料制成。参考图4c，示出了具有变化横截面的垫插入件。垫58d可以是尺寸能够压配合到环形开口58c内的圆柱形。替代地，垫插入件58d可以设有切口58d’。切口58d’与垫58的环形开口58c中的唇部匹配。这种唇部-切口的设置有助于将垫插入件58d容易地插入到垫58中，并且还促进了垫插入件58d在垫58中的机械保持动作。该机械保持动作消除了对焊接、粘接等的需求。在其它实施方式中，垫插入件58d可以是在膛孔中具有变化的台阶的圆柱形，以便于使其保持在夹钳垫58中，或者是截面具有逐渐增大或者逐渐减小的直径的圆柱形，或者是正方形、矩形并可在表面上设有倒钩以便于使其保持在夹钳垫58中。其它实施方式可以使用胶水或者焊接将垫插入件58d保持在合适的位置。在其它实施方式中，夹钳垫58可以具有在沿着垫58的长度的任何位置定位的多个垫插入件。
可以从本发明的一种或多种形式中获得一些好处和优点。使组织垫具有基体材料和至少一种垫插入件材料能够使基体材料和至少一种垫插入件材料选择不同的硬度、刚度、润滑度、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，以提高组织垫的耐磨性，当采用较高的夹钳力时，这种耐磨性是很重要的，因为组织垫在较高夹钳力下比在较低夹钳力下磨损得快。该实施方式的其它好处和形式公开在2005年2月24日提交的序列号为11/065378并共同转让给本申请的受让人的美国专利申请中。
参考图4c，其示出了夹钳臂56的一种形式。在这种结构中，夹钳臂是由单件材料冲压而成。这种冲压工艺产生截面56a和向内倾斜以形成通道的凸缘56a’，该凸缘适于接收夹钳垫58上相应形状的楔形件或者凸缘58e。该单件冲压工艺的优点在于可以快速且便宜地制造夹钳臂56。另外，夹钳臂56省去了传统的超声夹钳臂中的垫止挡件，而是靠在焊接销56b(见图4a)以将夹钳垫58保持在适当位置，从而进一步降低制造成本。
尽管描述了单件式夹钳臂，但如本领域中已知并理解的，夹钳臂56可以包括远侧的T形狭槽和近侧的楔形或鸽尾形狭槽，远侧的T形狭槽用于接收夹钳垫远侧的T形凸缘，近侧的楔形或鸽尾形狭槽用于接收夹钳垫近侧的楔形凸缘。如本领域中的技术人员将会理解的，凸缘和相应的狭槽可以选择形状和尺寸以将夹钳垫固定到夹钳臂上。图示的凸缘结构仅是示例性的并容纳一种实施方式的具体夹钳垫材料，但凸缘的具体形状和尺寸可以变化，包括但不限于相同尺寸和形状的凸缘。对于均一的组织垫来说，凸缘可以是一体结构。另外，也可以想到将夹钳垫机械连接到夹钳臂上的其它方法，例如铆接、粘接、压配合或者技术人员可以想到的任何其它的紧固方法。
用于替换夹钳垫58的方法的第一种形式包括以下一个或多个步骤：a)拆下焊接销56b；b)将夹钳臂56从外部护套72上拆下；c)将垫插入件58d从夹钳垫58上拆下；d)将夹钳垫插入到夹钳臂56中；和e)借助焊接销56b将夹钳臂56与外部护套72接合。在这种拆除和替换过程中，在步骤“d”中插入的新夹钳垫58可以是均一特氟隆结构，可以是合成结构，可以是多片式特氟隆结构或者合成材料，或者可以包含上述的任意组合的垫插入件。垫插入件可以是新的垫插入件或者从“用过的”夹钳垫得到的垫插入件。
用于替换夹钳垫58的方法的第二种形式包括以下一个或多个步骤：a)打开夹钳臂56上的凸缘(见图4b)；b)将夹钳垫58从夹钳臂56上拆下；c)将垫插入件58d从夹钳垫58上拆下；d)将垫插入件58d插入到夹钳臂56中；和e)关闭夹钳臂56上的凸缘。在这种拆除和替换过程中，在步骤“d”中插入的新夹钳垫58可以是均一特氟隆结构，可以是合成结构，可以是多件式特氟隆结构或者合成材料，或者可以包含垫插入件或上述的任意组合。垫插入件可以是新的垫插入件或者从“用过的”夹钳垫得到的垫插入件。
用于替换具有基体材料和至少一种垫插入件材料的夹钳垫的方法的第三种形式包括以下一个或多个步骤：a)将夹钳垫从夹钳臂56上拆下；b)提供在其远端处具有开口的新夹钳垫；c)将尺寸与所述开口配合的垫插入件插入到开口中；和d)将夹钳垫连接到夹钳臂上。
现在参考图2、图4a、图4b、图5和图6，夹钳构件60相对于刀79的枢转运动受到夹钳臂56上设置的一对枢转点的影响，该对枢转点分别与外部护套72和内管76接合。外部护套72通过外管保持器29靠在手柄70上。夹钳臂56借助夹钳臂56上的相应通孔52a和52b和外部护套72上的通孔52c和52d可枢转地连接到外部护套72上。销56b滑动穿过通孔52a-52d以将夹钳臂56固定到外部护套72上。在一种实施方式中，销56b激光焊接到夹钳臂56上，从而使销56b固定到夹钳臂56上并相对于外部护套72旋转。任何线性紧固件都能满足需要并且本发明不限于焊接销固定。
内管76沿着外部护套72的纵向轴线移动并通过外管保持器29靠在手柄70上。夹钳臂56上的支柱54a、54b与位于内管76远端的狭槽54c接合。夹钳臂56枢转连接到内管76和外管72上，这为端部执行器81提供了更大的强度，并且使由于过度的轴向或扭转误用载荷引起的失效模式最小化。另外，该实施方式还提高了端部执行器81提供超过5镑的夹钳力的有效性。因此，致动构件76相对于外部护套72和波导80的往复运动影响夹钳臂56相对于端部的刀79的枢转运动。
在本发明的一种实施方式中，内管76和外部护套72通过本领域中已知并理解的辊压结构(rolled structure)制造。这种辊压结构与挤压或者其它类似的制造工艺相比，能够显著地节省成本。这里，也可以想到其它制造技术，例如拉制管。
现在参考图1、图2和图7，壳体70包括近端、远端和在壳体70内沿着纵向延伸的腔59。腔59被构造来接收开关组件300和换能器组件50，换能器组件通过开关组件300与壳体68接合。
换能器50包括固定地设置在手持件的换能器主体50内的第一导电环400和第二导电环410。在目前的实施方式的一种形式中，第一导电环400包括设置在换能器50和变幅杆(horn)130之间的环构件。优选地，第一导电环400邻近腔162内的凸缘构件160形成或者作为凸缘构件160的一部分而形成并与其它的电气部件电绝缘。第一导电环400锚固到形成在换能器50主体内的不导电平台或者类似结构(未示出)上并从平台向上延伸。第一导电环400通过一根或多根电线(未示出)电连接到电缆22上(图1)，所述电线沿着换能器50的长度延伸到第一导电环400。
换能器50的第二导电环410同样包括设置在换能器50主体和变幅杆130之间的环构件。第二导电环410设置在第一导电环400和变幅杆130之间，因此第一导电环400和第二导电环410是共轴构件。第二导电环410同样与第一导电环400和容纳在换能器50内的其它电气部件电绝缘。与第一导电环400相同，第二导电环410优选锚固到不导电平台并从该平台向上延伸。应当理解，第一导电环400和第二导电环410彼此充分间隔开以彼此电绝缘。这可以通过在第一导电环400和第二导电环410之间或环400、410与换能器内的其它构件之间设置一个或多个间隔件413来实现。第二导电环410也通过一根或多根电线(未示出)电连接到电缆22(图1)上，所述电线沿着换能器50的长度延伸到第二导电环410。这样设置第二导电环410以部分限定从电缆22到开关机构300的第二电通路。一种合适的超声换能器50是美国俄亥俄州辛辛那提的伊西康内出售的Model No.HP054。
在目前的实施方式的一种形式中，换能器50的远端螺纹连接到波导80的近端。换能器50的远端还与开关组件300接合，以为医生提供对外科器械100的手指致动控制。
现在参考图8a-图8c，开关组件300包括按钮组件310、柔性电路组件330、连接器组件350、第一弹簧滑环式导体360和第二弹簧滑环式导体370。连接器组件350大致为圆柱形并通过开关组件350和壳体部分68和69上的相应支撑座支撑在手柄70内。连接器组件350限定第一腔353、安装凸毂(mounting boss)352和第二腔351。腔353的尺寸能够接收换能器50的近端，由此，变幅杆130穿过腔351以与波导80接合。安装凸毂352接收滑环式导体360和370，滑环式导体360和370又分别与环触头400和410电接合。
现在具体参考图8a，滑环式导体360和370通常是滑到连接器组件350上的端部开口的O形弹簧。每个弹簧滑环包括两个压力接触点(361a、361b和371a、371b)，两个压力接触点分别接触换能器的环导体400和410。滑环360和370的弹性张力引起接触点361a、361b，371a、371b与导体400和410确实接触。很明显，即使医生在使用器械的过程中转动换能器50，滑环结构也能够使电接触均匀。如本领域中已知并理解的，各个滑环的接线柱364和374(未示出)电连接到柔性电路330内的各个导体上以构成完整电路。
柔性电路330通过换能器50在按钮311、312和发生器30之间提供了机电接口。柔性电路包括两个薄膜开关(dome switch)332和334，薄膜开关通过分别按压相应的按钮组件310的按钮311或312致动。薄膜开关332和334是电接触开关，当被压下时为发生器30提供电信号，如图8d中的电气布线图所示的。柔性电路330还包括二极管封装件336内的两个二极管，也在图8c中示出。如本领域的技术人员已知的，柔性电路330具有分别借助电凸片364和374连接到滑环式导体360和370上的导体335和337。电凸片又电连接到环导体400和410上，环导体又连接到电缆22中的导体上，电缆22连接到发生器30。凸片364和374(未示出)焊接到导体335和337上。
柔性电路330部分折叠并通常固定连接到手柄组件70的壳体部分68上从而使薄膜开关334和332与在手柄组件70的壳体部分69的背面(未示出)接合。所述背面在操作过程中为薄膜开关提供了牢固的支撑，如下文所述。薄膜开关334和332可以通过方便的方法，例如通过粘合剂，固定地连接到背面上。柔性电路通过使开关组件350上的对准销354和柔性电路330上的相应对准孔338固定到连接器组件350上。如本领域的技术人员能够理解的，可以使用各种电路结构在按钮和发生器之间提供电接合，包括模塑电路或者标准电线连接。
层叠在柔性电路上的是按钮组件310，按钮组件具有与柔性电路330相应的鞍状。按钮组件310包括两个按钮，即远侧按钮312和近侧按钮311，它们具有以摇臂形式设置的相应压力柱315和314。本领域的技术人员已知的其它类型的开关也同样可用。摇臂式的按钮组件310可转动地连接到手柄组件70上，以为按钮组件310提供定心动作。如已经很明显的，通过按下按钮311和312，相应的压力柱314和315压靠相应的薄膜开关334和332以致动图8c中所示的电路。开关312和311位于超声器械的中心线上从而使医生可以使用左手或者右手操作按钮。当医生按下开关312时，发生器会响应某个功率水平，例如最大(max)功率设置；当医生按下开关311时，发生器会响应某个功率水平，例如最小(min)功率设置，这符合接受的用于按钮定位和相应功率设定的行业实践。
替代地，按钮可以模制到连接器组件350或者手柄组件70的壳体部分68中，以减少部件的数量并增强整个装置的可靠性。按钮可以通过小悬臂部件连接，这允许按钮牢固连接到其它部件上，同时也使很小的力就能致动按钮。
在本发明的前述实施方式中，开关311和312构造成为医生提供符合人机工程学的合意的抓握和操作。开关可以设置在医生的食指或中指自然摆动的范围内，不论是左手抓握外科器械100还是右手抓握。再次参考图8b，在目前的实施方式中，在按钮312上一体形成一系列分区物，例如脊312a和/或凹陷或者“峰和谷”。所述脊为医生提供关于按钮位置和按钮是最小功率致动还是最大功率致动的触觉反馈。这种触觉反馈对医生来说是非常重要的，由此医生可以持续地估计外科手术部位，准确地知道哪一个按钮正被致动，而不需要观看器械100。
参考图9，医生的左手接触器械100。拇指准备好致动扳机手柄34，食指和中指易于与按钮组件310接合。医生的无名指和小指抓住手柄70。
在图10中，医生的右手按压扳机手柄34以使夹钳臂56向刀79闭合。右手的食指能够轻易地接触按钮312以启动最大功率，右手的中指能够轻易地接触按钮311b以启动最小功率。可观察到，医生可以使用食指启动最大功率，并且使用中指来启动最小功率。摇臂式开关允许医生将手指靠在最小功率按钮和最大功率按钮上，同时确保两个按钮不会同时被致动。摇臂式开关便于使切割速度快速变化，例如使切割速度从最大变成最小，再变成最大。在以前的装置中，医生不得不将脚从一个踏板移动到另一个踏板或者使手指从一个按钮移动到另一个按钮。在一些例子中，医生还不得不将视线从手术区域移开以定位所需的脚踏板或者所需的按钮。摇臂式开关允许医生在手术的所有阶段将两个手指靠在开关上，从而不需要看着或者寻找所需的按钮。
参考图9和10，示出了外科器械100的一种形式，并图示了医生的手指放置在器械100上。器械100的闭合是通过将拇指穿过扳机手柄34中的开口34a放置并压下扳机手柄34实现的。(穿过开口34a插入拇指来致动扳机手柄34仅是示例性的。手大的医生可以选择使拇指在扳机手柄34外侧来致动扳机手柄34，扳机手柄34设有脊34b使得在手术过程中能够利用在扳机手柄34外的拇指或者任何其它手指或者手的一部分)。开口34a的尺寸通常能够接收不同尺寸的手指和拇指，很明显，根据医生的性别和个头可以进行一些变化。
在本发明的一种替代形式中，扳机手柄34和抓握手柄70在其限定开口34a和68a的内表面上具有可软接触的模制热塑性弹性体衬里(未显示)。塑性材料衬里为医生提供了舒适性并防止手指疲劳。塑性材料衬里还在手柄和医生的拇指和手指之间提供了改进的抓握表面。这对于接受男医生和女医生的多种手指尺寸来说尤其有利，并且仍然提供了舒适和稳定的抓握表面。塑性材料衬里可以平滑或者在衬里的表面上模制有轮廓，例如肋。其它轮廓可以是凸起、峰和谷。对本领域的技术人员来说很明显的各种其它形状和界面也落在本发明的范围内。
现在参考图2、图11和图12，示出了一件式扭矩扳手500。在一种实施方式中，扭矩扳手500设有悬臂501，悬臂501围绕扭矩扳手500的中心线环形地设置。在一种实施方式中，悬臂501包括相对于悬臂501垂直向内地设置的齿501a。在本发明的一种实施方式中，齿501a设有凸轮斜面501b，凸轮斜面501b相对于臂501和齿501a之间的直角呈25°角设置。
现在参考图12，图中示出了外管保持器29。外管保持器29包括沿保持器29的外周以垂直方式突出的花键齿轮29a。花键齿轮29a包括相对于保持器29的外周和花键齿轮29a之间的直角呈25.6°角设置的凸轮斜面29b。设计人员可以想到齿和凸轮斜面的其它角度。
在操作时，扭矩扳手开口502与外部护套72对准并沿着护套72的基本整个长度被引导。扭矩扳手唇缘503接合手持件70的远端。悬臂齿501a可滑动地接合外管保持器29的花键齿轮29a。凸轮斜面501b可滑动地接合保持器凸轮斜面29b。顺时针环形运动或者扭矩通过翼板504传递到扭矩扳手500。该扭矩再通过臂501和齿501a传递到齿轮29a，齿轮又将扭矩传递经由绝缘销27传递给波导80。当使用者施加5至12英寸-磅的扭矩并保持手持件50静止时，斜面501b和29b引起臂501背离扳手500的中心线运动或弯曲，确保了使用者不会将波导80过分绷紧在到变幅杆130上(图7)。当通过翼板504向扳手500施加逆时针扭矩(并保持手持件50静止)时，齿501a和29a的垂直平坦侧相抵接，从而允许使用者将与施加到翼板上的力成比例的扭矩传递到波导80和变幅杆130之间的界面上，以便于使器械100从手持件50移除。扭矩扳手500可以由耐用的塑性材料构成，例如，聚碳酸酯或者液晶聚合物。还可以想到，扳手500替代地由包括其它塑性材料、陶瓷或者金属的多种材料制成。
在另一种实施方式中(未示出)，翼板和悬臂组件可以是通过机械方法或者化学方法，例如粘合剂或胶水，连接起来的单独的部件。
现在参考图2、图5、图6和图13，力限制机构95设有波形弹簧94。波形弹簧94可操作地连接到轭状件33，轭状件又通过扳机手柄34驱动。波形弹簧94产生端部执行器81的载荷并保持端部执行器载荷的一致性。结果，端部执行器载荷得到更严格的控制，减少了部件误用载荷条件。扳机手柄34和手柄70之间的机械干涉或者接触是抵抗波形弹簧94被完全压缩的安全保护器，由此防止弹簧材料屈服和波形弹簧94在接下来的夹钳臂关闭中失效。如本领域的技术人员能够理解的，机械止挡件弹簧力限制系统可以应用在遇到夹钳力的其它基于能量(诸如射频、微波和激光)的外科装置以及机械装置中，例如夹具分配器、抓持器和缝合器。
在目前的实施方式的一种形式中，波形弹簧94具有大约每英寸43磅的弹簧常数。波形弹簧94被预加载而获得要实现所需的横切力的所需力，并且该力是夹钳臂56连接装置的机械效益和装置中的波擦损耗的函数。在目前的实施方式的第二种形式中，波形弹簧94被预加载大约13磅。
现在参考图13，曲线83表示作为用于关闭夹钳臂的扳机手柄34的旋转角函数的扳机手柄34的力，曲线84表示作为用于打开夹钳臂的扳机手柄34的旋转角函数的扳机手柄34的力。点82a表示轭状件33开始偏转或压迫波形弹簧94的点，随着进一步压迫扳机手柄34，力逐大直到在偏转点82b处达到波形弹簧94的预加载荷值，并且力曲线的斜率减小。点82c表示扳机手柄34接触到手柄70导致机械停止处的扳机手柄上的力。
在图13中，曲线83表示通过弹簧12施加到扳机手柄34上的力。点83a表示扳机手柄34与手柄70脱离且波形弹簧和弹簧12都向轭状件33施加力的点。点83b表示在扳机手柄34和夹钳臂56的打开行程中扳机手柄34向使用者作用的最大力。如从图13中的闭合区域中的曲线82和83可以理解的，将扳机手柄34保持在闭合位置所需的力比要使其到达闭合位置所需的力小。两个力的差证明在较长的手术过程中是有利的，因为在较长的手术过程中手的疲劳是一个因素。例如，在较长的横切过程中，医生可能不经意地放松对扳机手柄34的压力；利用保持扳机手柄34完全闭合所需的较小的力，可以实现一致的切割和凝结。
现在参考图2，外科器械100还设有听觉装置和触觉装置，用于指示医生扳机已经实现了全部行程并且夹钳臂56正在向组织施加正确的接合力。位于手柄70中的棘爪(clicker)339在闭合或打开时瞬时与扳机手柄凸片34a接触，从而使扳机手柄凸片34a引起棘爪339屈服并弹回到其原始位置，由此能够听到“咔嗒”声并感触到“咔嗒”动作。这在长时间的外科手术或者组织横切过程中很有用，因为在该过程中，医生可能在不知道的情况下放松抓握，可能使从夹钳臂56传递到组织的压力不经意地减小。
棘爪339通常是平面的并由柔性的塑性材料制成，其能够在棘爪与扳机手柄凸片34a接合时充分偏转从而为医生提供指示端部执行器81完全闭合的听觉和/或触觉信号。有利地，凸片34a在扳机手柄34从完全闭合位置沿着相反的方向转动时碰撞棘爪339并使其偏转，从而为医生提供指示端部执行器81不再完全闭合的听觉和/或触觉信号。如本领域的技术人员能够理解的，所述指示装置可以是触觉的、听觉的、视觉的或者其组合。可以使用各种类型的指示器，包括薄膜开关、固体止挡件、悬臂弹簧或者本领域已知的任何数量的机械或者电开关。可以使用其它各种装置向医生提供反馈，包括但不限于灯、蜂鸣器和振动元件。
优选地，在手术前处理上述的超声夹钳凝结器设备。首先，获得新的或者旧的超声夹钳凝结器设备，如果需要，对其进行清洗。然后将超声夹钳凝结器设备消毒。在一种消毒技术中，将超声夹钳凝结器设备放置在闭合和密封的容器中，例如塑料袋或者高密度聚乙烯合成纸袋中。选择地，将超声夹钳凝结器设备束缚在容器内与包括扭矩扳手的其它部件形成套件。然后用任何一种传统的医学消毒技术例如γ辐射、x射线、高能电子或者ETO(环氧乙烷)对容器和超声夹钳凝结器设备，以及任何其它部件进行消毒。消毒将超声夹钳凝结器设备和容器中的细菌杀死。然后将消过毒的超声夹钳凝结器设备储存在消过毒的容器中。密封的容器在其医药应用打开之前使超声夹钳凝结器设备保持消毒状态。
尽管通过对若干实施方式的描述示出了本发明，但申请人并不意在将所附的权利要求的精神和范围限制或者限定到这些细节。本领域的技术人员在不脱离本发明的范围的情况下能够进行很多种变形、改变和替代。而且，本发明相关的每个元件的结构可以替代地描述为能够用于提供通过该元件实现的功能的部件。因此，本发明仅仅由所附的权利要求的精神和范围加以限定。

Claims (18)

1.一种超声外科波导，该超声外科波导具有近侧部分和远侧部分，所述远侧部分为所述波导的远侧一半并包括超声外科刀主体，所述刀主体具有远侧尖端，该尖端是最远侧的振动腹点；
其中，所述远侧部分包括大于单位增益的第一增益台阶和大于单位增益的第二增益台阶。
2.根据权利要求1所述的超声外科波导，其中，所述波导还包括第一最远侧振动节点，并且所述第一增益台阶和第二增益台阶中的一个设置在所述第一最远侧振动节点处。
3.根据权利要求1所述的超声外科波导，其中，所述第一增益台阶和第二增益台阶的至少一个是选自由以下组成的增益部件：外径或者周长、斜面、纵向孔、横向孔、空隙、平表面、表面狭槽的离散变化和材料的变化。
4.根据权利要求1所述的超声外科波导，其中，所述第一增益台阶和第二增益台阶的至少一个是波导从第一直径到第二直径的变化。
5.根据权利要求1所述的超声外科波导，其中，所述波导还包括第二最远侧振动节点，并且所述第一增益台阶和第二增益台阶中的一个设置在所述第二最远侧振动节点处。
6.根据权利要求1所述的超声外科波导，其中，共振频率和防共振频率之间的差大于或等于50Hz。
7.根据权利要求1所述的超声外科波导，还包括第一最远侧振动节点和第二最远侧振动节点，其中所述第一增益台阶设置在所述第一最远侧振动节点处并且所述第二增益台阶设置在所述第二最远侧振动节点处。
8.根据权利要求7所述的超声外科波导，其中，共振频率和防共振频率之间的差大于50Hz。
9.根据权利要求7所述的超声外科波导，其中，共振频率和防共振频率之间的差大于70Hz。
10.根据权利要求7所述的超声外科波导，其中，共振频率和防共振频率之间的差从50Hz到80Hz。
11.一种超声外科波导，该超声外科波导具有近侧部分和远侧部分，所述远侧部分为所述波导的远侧一半并包括超声外科刀主体，所述刀主体具有远侧尖端，该尖端是最远侧的振动腹点；
其中，所述远侧部分在靠近所述刀主体处包括大于单位增益的第一增益台阶和大于单位增益的第二增益台阶。
12.根据权利要求11所述的超声外科波导，其中，共振频率和防共振频率之间的差大于或等于50Hz。
13.一种超声外科波导，该超声外科波导具有近侧部分和远侧部分，所述远侧部分为所述波导的远侧一半并包括超声外科刀主体，所述刀主体具有远侧尖端，该尖端是最远侧的振动腹点；
其中，所述远侧部分包括大于单位增益的第一增益台阶和小于单位增益的第二增益台阶。
14.根据权利要求13所述的超声外科波导，其中，所述波导还包括第一最远侧振动节点，并且所述第一增益台阶和第二增益台阶中的一个设置在所述第一最远侧振动节点处。
15.根据权利要求13所述的超声外科波导，其中，所述第一增益台阶和第二增益台阶的至少一个是选自由以下组成的增益部件：外径或者周长、斜面、纵向孔、横向孔、空隙、平表面、表面狭槽的离散变化和材料的变化。
16.根据权利要求13所述的超声外科波导，其中，所述第一增益台阶和第二增益台阶中的至少一个是所述波导从第一直径到第二直径的变化。
17.根据权利要求13所述的超声外科波导，其中，所述波导还包括第二最远侧振动节点，并且所述第一增益台阶或者第二增益台阶的一个设置在所述第二最远侧振动节点处。
18.一种超声外科波导，该超声外科波导具有近侧部分和远侧部分，所述远侧部分为所述波导的远侧一半并包括超声外科刀主体，所述刀主体具有远侧尖端，该尖端是最远侧的振动腹点；
其中，所述远侧部分在靠近所述刀主体处包括大于单位增益的第一增益台阶和小于单位增益的第二增益台阶。
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