CN102579108A - 改进的外科器械 - Google Patents

改进的外科器械 Download PDF

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CN102579108A
CN102579108A CN2012100591021A CN201210059102A CN102579108A CN 102579108 A CN102579108 A CN 102579108A CN 2012100591021 A CN2012100591021 A CN 2012100591021A CN 201210059102 A CN201210059102 A CN 201210059102A CN 102579108 A CN102579108 A CN 102579108A
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end effector
surgical instruments
tissue
frequency
vibration
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CN102579108B (zh
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E·T·维纳
K·B·克拉默
F·B·斯图伦
A·K·玛丹
K·L·豪瑟
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Ethicon Endo Surgery Inc
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61N7/00Ultrasound therapy
    • A61N7/02Localised ultrasound hyperthermia
    • AHUMAN NECESSITIES
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    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/320068Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/320068Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A61B17/320092Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017Electrical control of surgical instruments
    • A61B2017/00022Sensing or detecting at the treatment site
    • A61B2017/00084Temperature
    • AHUMAN NECESSITIES
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    • A61B2017/00017Electrical control of surgical instruments
    • A61B2017/00022Sensing or detecting at the treatment site
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    • AHUMAN NECESSITIES
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    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017Electrical control of surgical instruments
    • A61B2017/00115Electrical control of surgical instruments with audible or visual output
    • A61B2017/00128Electrical control of surgical instruments with audible or visual output related to intensity or progress of surgical action
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00353Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery one mechanical instrument performing multiple functions, e.g. cutting and grasping
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
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    • A61B17/320068Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/320068Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A61B2017/320071Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with articulating means for working tip
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/320068Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A61B2017/320089Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic node location
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/320068Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A61B17/320092Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw
    • A61B2017/320094Surgical 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/320068Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A61B17/320092Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw
    • A61B2017/320095Surgical 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00607Coagulation and cutting with the same instrument
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00642Sensing and controlling the application of energy with feedback, i.e. closed loop control
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    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00773Sensed parameters
    • A61B2018/00791Temperature

Abstract

本发明涉及一种外科器械。所述外科器械可以包括换能器、端部执行器、发生器和控制电路。所述换能器可以被构造用于提供振动。所述端部执行器可以连接到所述换能器,并且可以沿纵向轴线从所述换能器延伸。所述发生器可以向所述换能器提供电信号。此外,所述控制电路可以响应于所述端部执行器的振动频率变化来改变所述电信号的电流幅值。根据多个实施例,所述控制电路可以检测对所述端部执行器振动频率的第一贡献,所述第一贡献来自于接触所述端部执行器的组织。此外,根据多个实施例,所述控制电路可以指示所述端部执行器振动频率的变化。

Description

改进的外科器械
本申请是申请日为2008年7月31日、国际申请号为:PCT/US2008/071706、国家申请号为:200880101533.1、名称为“改进的外科器械”的进入中国国家阶段的国际申请的分案申请。
技术领域
本申请涉及改进的外科器械。
背景技术
包括空芯器械和实芯器械在内的超声器械用于安全有效地治疗许多病症。超声器械是有利的,因为使用以超声频率传输至外科端部执行器的机械振动形式的能量可使超声器械用于切除和/或凝固有机组织。当以合适的能量级传输至有机组织并且使用合适的端部执行器时,超声振动可用于切除、解剖、拉升或烧灼组织或用于使肌肉组织与骨骼分离。此类器械可用于开放性手术或微创手术,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)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,从而有助于切除和凝固。由于超声器械的该特性,因此特定的超声致动的端部执行器设计用于执行许多功能,包括(例如)切除和凝固。
例如,通过电激励换能器在外科端部执行器中引发超声振动。该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管传输至外科端部执行器,该超声波导管从换能器部分延伸至外科端部执行器。将波导管和端部执行器设计成以与换能器相同的频率进行共振。因此,当端部执行器连接到换能器时,整个系统的频率与换能器自身的频率相同。
端部执行器的顶端d处纵向超声振动的零至峰的幅值在共振频率下表现为如下式给定的简单的正弦曲线:
d=Asin(ωt)
其中:
ω为2π乘以循环频率f的角频率;并且
A为零至峰的幅值。
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。
超声外科器械可分为两类:单元件端部执行器器械和多元件端部执行器器械。单元件端部执行器器械包括诸如手术刀和球状凝固器的器械。当组织柔软并且支撑不紧时,单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。在一些情况下,需要很大的压力才能将超声能量有效地传输至组织。这样无法夹住组织的结果会进一步导致在施加超声能量时不能够完全接合组织表面,从而导致无法完成预期的止血和组织接合。在这些情况下,可使用多元件端部执行器。诸如夹紧凝固器的多元件端部执行器器械包括将组织紧压在超声刀片上的机构,该机构可以弥补这些缺陷。
虽然超声外科器械被广泛用于许多外科手术应用中,但由于不能对组织和端部执行器的状态做出响应,其实用性受到限制。例如,当超声器械的端部执行器用于凝固和/或切割组织时,常常会发热。这会导致器械性能不稳定。此外,使用该器械的临床医生也无法知道器械开始凝固组织的时间,器械开始切割组织的时间,或关于组织的任何其他信息。
超声器械的另一些缺点来自于现有的端部执行器设计。在现有设计中,只有端部执行器的顶端(如刀片)是超声驱动的。因此,接触刀片并距离顶端超过波长一部分的组织将根本不受影响。此外,由于波必须从换能器向端部执行器顶端传播,而现有的端部执行器不够灵活,因此限制了其关节运动能力,从而限制了其在腹腔镜和内窥镜手术应用中的使用。
发明内容
在一个一般方面,多个实施例涉及外科器械。外科器械可以包括换能器、端部执行器、发生器和控制电路。换能器可以被配置用于提供振动。端部执行器可以连接到换能器,并且可以从换能器沿纵向轴线延伸。发生器可以向换能器提供电信号。此外,控制电路可以根据端部执行器的振动频率变化改变电信号的电流幅值。根据多个实施例,控制电路可以检测对端部执行器振动频率的第一贡献,第一贡献来自于接触端部执行器的组织。此外,根据多个实施例,控制电路可以显示端部执行器振动频率的变化。
在另一个一般方面,多个实施例涉及具有换能器、夹紧机构和控制电路的外科器械。换能器可以被配置用于提供振动。端部执行器可以连接到换能器,并且可以从换能器沿纵向轴线延伸。夹紧机构可以向端部执行器平移。控制电路可以计算反映胶原变性系数随时间变化的曲线。可以在考虑下列因素的情况下计算胶原变性系数:端部执行器向组织的一部分传输的能量;施加到端部执行器和夹紧机构之间的组织的一部分上的夹紧力;端部执行器的位移;以及端部执行器的振动频率。根据多个实施例,控制电路还可以识别曲线斜率从基本为负的斜率到基本为零的斜率的第一变化,并且根据第一变化指示组织凝固的开端。此外,根据多个实施例,控制电路可以识别具有基本恒定的斜率的曲线的第一区域。控制电路还可以计算描述第一区域的区域属性,并且得出与端部执行器接触的组织部分的组织特性。
在又一个一般方面,多个实施例涉及包括端部执行器的外科器械。端部执行器可以包括纵向延伸穿过端部执行器的中央构件和多个径向模式换能器。径向模式换能器可以设置在中央构件周围,并且可以被成形为通过沿垂直于纵向轴线的方向振动而对电信号作出响应。驻波可以是超声波。
附图说明
多个实施例的新特征在所附权利要求书中进行了详细描述。然而结合以下描述和如下附图才能最好地理解多个实施例(有关手术组织和方法)以及其他目的和优点。
图1示出包括外科器械和超声发生器的外科系统的一个实施例。
图2示出图1所示外科器械的一个实施例。
图3示出图1所示外科器械的一个实施例的分解图。
图4示出可与图1所示外科器械一同使用的夹紧机构的一个实施例。
图5示出图1所示外科器械的一个实施例的剖视图。
图6示出图1所示外科器械的一个实施例的各种内部组件。
图7示出图1所示外科器械的驱动托架的一个实施例。
图8示出图1所示外科器械的驱动箍的一个实施例。
图9示出包括外科器械的外科系统的一个实施例,该外科器械具有单元件端部执行器。
图10示出外科器械的一个实施例的框图。
图11示出描述外科器械实例测试结果的图。
图12示出描述端部执行器频率和端部执行器温度之间关系的图。
图13示出外科器械的一个实施例的框图。
图14示出描述胶原变性系数曲线的图。
图15示出描述胶原变性系数曲线的图。
图16示出一系列曲线,这些曲线描述胶原变性系数曲线第一区域的归一化值与夹紧力、功率电平、外径和壁厚之间的关系。
图17示出用于包括径向模式换能器的外科器械的端部执行器的一个实施例。
图18示出安装在包括夹臂的外科器械上的图17的端部执行器的一个实施例。
图19示出包括柔性中央构件的图17的端部执行器的一个实施例。
图20示出包括限定凹陷的换能器的图17的端部执行器的一个实施例。
图21示出图20的端部执行器的一个实施例。
具体实施方式
在详细阐述多个实施例之前,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描述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,以下公开的外科器械和刀片构造仅为示例性的,而并非旨在限制它们的范围或应用。另外,本文以下描述的刀片和端部执行器的设计件可结合任何合适的器械进行使用。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。
超声外科器械和刀片的例子公布于美国专利No.5,322,055、5,954,736、6,309,400B2、6,278,218B1、6,283,981B1和6,325,811B1,其全文以引用方式并入本文中。这些参考文献公开了超声外科器械设计件和刀片设计件,其中令人感兴趣的是刀片的纵向模式。结果为器械内产生纵向驻波。因此,器械具有横向运动等于零的波节,以及横向运动处于其最大值的波腹。器械的组织端部执行器通常位于波腹以使其纵向运动最大化。
现在将描述多个实施例,以便全面了解本文所公开的装置和方法的结构、功能、制造和使用原理。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,并且多个实施例的范围仅由权利要求书限定。就一个实施例进行图解说明或描述的特征,可与其他实施例的特征进行组合。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。
应当理解,本文根据临床医生握住外科器械的手柄组件或其他类似件的情况来使用术语“近端”和“远端”。因此,端部执行器相对于较近的手柄组件而言处于远端。还应该理解,为方便和清晰的目的,本文根据临床医生握住手柄组件或其他类似件的情况来使用诸如“顶部”和“底部”的空间术语。然而,手术器械可以在许多方向和位置使用,并且这些术语并非限制性和绝对化的。
图1示出包括外科器械和超声发生器的外科系统的一个实施例。图2示出图1所示器械的一个实施例。在图1至2示出的实施例中,外科系统10包括超声夹持凝固器器械120和超声发生器30。外科器械120包括超声驱动单元50。如进一步所述,驱动单元50的超声换能器和夹持器械120的超声端部执行器180一起提供外科系统10的声波组件,该声波组件由发生器30提供动力时可以为外科手术提供超声能量。应注意的是在一些应用中,超声驱动单元50称为“手柄组件”,因为外科系统10的外科器械120被构造用于使临床医生在各种手术和操作中握紧并操纵超声驱动单元50。器械120可包括剪刀状夹紧装置,该装置除了有利于操纵超声驱动单元50外还有利于定位和操纵器械120。
外科系统10的发生器30以选定的由发生器30的控制系统决定的偏移、频率和相位通过电缆32发送电信号。如进一步所述,该信号使外科器械120的声波组件的一个或多个压电元件沿纵向轴线膨胀和收缩,从而将电能转换为机械运动。该机械运动引起超声能量的纵波,该纵波以声学驻波的形式在声波组件中传播,从而使声波组件以选定的频率和偏移振动。端部执行器180与患者的组织接触,以便将超声能量传递到组织。例如,端部执行器的刀片180′的末端部分可以与组织接触。如下文进一步所述,可利用诸如夹具或夹紧机构的外科工具将组织紧压在刀片180′上。
端部执行器180与组织连接,因此由于组织内部的摩擦、声吸收、以及粘滞损失产生了热能或热量。这样的热量足够使蛋白质氢键断裂,从而使高度结构化的蛋白质(例如胶原蛋白和肌肉蛋白)变性(例如组织化程度降低)。由于蛋白质变性形成的粘性凝固物会封闭或凝结小血管。该效应持续较长时间时则会造成更大血管的深度凝固。
将超声能量传输至组织会导致包括机械撕裂、切除、空蚀、细胞破碎以及乳化在内的其他效应。所得切除量和凝固程度随以下因素变化:端部执行器180的偏移、振动频率、用户施加的压力值、端部执行器180的锋利度、以及端部执行器180与组织之间的连接。
在图1示出的实施例中,发生器30包括与发生器30形成一体的控制系统、电源开关34、以及触发机构36。电源开关34控制传输至发生器30的电能,并且当由触发机构36启动时,发生器30提供能量以驱动具有手术系统10的频率的声波组件,并且以预定的偏移水平驱动端部执行器180。发生器30以任何合适的声波组件的共振频率来驱动或激发该声波组件。
当发生器30通过触发机构36启动时,电能连续地由发生器30施加到声波组件的换能器组合件或组件40上。发生器30的控制系统中的锁相环路监控声波组件的反馈。该锁相环路调整由发生器30发送的电能频率,以匹配声波组件的选定的振动纵向模式的共振频率。此外,控制系统中的第二反馈回路将传送至声波组件的电流维持在预选的恒定水平,以便在声波组件的端部执行器180处获得基本上恒定的偏移。
传送至声波组件的电信号将使端部执行器180的远端(例如刀片180′)在(例如)大约20kHz至250kHz的范围内纵向振动。根据多个实施例,刀片180′可在约54kHz至56kHz的范围内振动,例如以约55.5kHz振动。在其他实施例中,刀片180′可以其他频率振动,包括(例如)约31kHz或约80kHz。可通过(例如)控制由发生器30施加到声波组件的换能器组件40的电信号的幅值来控制刀片的振动偏移。
如上文所述,发生器30的触发机构36使用户可启动发生器30以便将电能连续地供给到声波组件。触发机构36可包括脚踏式激发开关,该开关通过电缆或电线可分离地连接或附接到发生器30。作为另外一种选择,触发机构可构造为合并在超声驱动单元50中的手动开关以使用户可以启动发生器30。
发生器30还具有电源线38,以便插入电外科单元或常规插座。可以设想发生器30还可通过直流(DC)电源供电,例如电池。发生器30可包括任何合适的发生器,例如得自Ethicon Endo Surgery,Inc的GEN04型发生器。
在图1和3示出的实施例中,外科器械的超声驱动单元50包括适于将手术员与声波组件的振动隔离的组合式壳体52。可将驱动单元壳体52成形为用户能够以常规方式抓握的形状,但可以设想主要通过器械壳体所提供的剪刀状装置来夹持和操纵现有的夹持凝固器器械120,如下文所述。虽然示出了组合式壳体52,但是壳体52可以包括单个组件或一体化组件。
超声驱动单元50的壳体52通常包括近端、远端、以及纵向伸入其中的腔体。壳体52的远端包括开口60,该开口构造用于使外科系统10的声波组件延伸穿过其中,并且壳体52的近端通过电缆32连接到发生器30。电缆32可包括导管或排放口62,以便将空气或其他流体引入超声驱动单元50的壳体52,从而冷却声波组件的换能器组件40。
超声驱动单元50的壳体52可由诸如
Figure BSA00000681167200081
的耐用塑料制成。作为另外一种选择,还可以设想壳体52可由包括其他塑料(例如液晶聚合物(LCP)、尼龙、或聚碳酸酯)和/或金属(例如铝、钢等)的多种材料制成。合适的超声驱动单元50为得自Ethicon Endo Surgery,Inc的HP054型超声驱动单元。
手术器械的声波组件通常包括第一声波部分和第二声波部分。第一声波部分可由超声驱动单元50承载,并且第二声波部分(以端部执行器180的形式,如下文所述)可由超声夹持凝固器120承载。第一声波部分的远端优选地通过螺纹连接可操作地连接到第二声波部分的近端。
在图2示出的实施例中,第一声波部分包括换能器组合件或组件40以及固定器械84,并且第二声波部分包括端部执行器180。该端部执行器180又可包括传输部件、或波导管181(图3)、以及末端部分、或刀片180′,以便与组织对接。
可以对声波组件的组件进行声波调谐,使得各组件的长度均为二分之一波长的整数倍(nλ/2),其中波长λ为预选定的或形成声波组件的纵向振动驱动频率f0的波长,并且n为任何非负整数。还设想声波组件可以结合任何合适的声波元件布置。
声波组件的换能器组件40将发生器30的电信号转换为机械能,从而使端部执行器180在超声频率下进行纵向振动运动。当为声波组件提供能量时,声波组件中就会产生振动运动驻波。沿着声波件的任何点处的振动运动偏移取决于沿着声波组件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(例如运动通常最小的位置),并且驻波的局部最大绝对值或峰值通常称为波腹。波腹与距其最近的波节之间的距离为四分之一波长(λ/4)。
在图2示出的实施例中,声波组件的换能器组件40(又称为“Langevin组合件”)通常包括换能部分90、第一共振器92、以及第二共振器94。换能器组件40的长度为二分之一系统波长的整数倍(nλ/2)。应当理解,换能器组件40的其他实施例可包括磁致伸缩换能器、电磁换能器或静电换能器。
第一共振器92的远端连接至换能部分90的近端,并且第二共振器94的近端连接至换能部分90的远端。第一共振器92和第二共振器94均可由钛、铝、钢、或任何其他合适的材料制成,并且最优选地是第一共振器92由303不锈钢制成,第二共振器94由7075-T651铝制成。第一共振器92和第二共振器94具有由多个变量确定的长度,这些变量包括换能部分90的长度、共振器92和共振器94中所用材料的声速、以及换能器组件40的所需基频f0。第二共振器94可以从其近端到远端向内逐渐变小,从而起到变速器的作用,并且增大超声振动偏移。
换能器组件40的换能部分90可包括交流正极96和交流负极98的压电部分,并且压电元件100在电极96和电极98之间交替。压电元件100可由任何合适的材料制成,例如锆钛酸铅、偏铌酸铅、钛酸铅、或其他压电材料。每个正极96、负极98和压电元件100都具有穿过中心的孔。正极96和负极98分别电连接至电线102和电线104。电线102和电线104将电信号从发生器30传输至电极96和电极98。
可通过螺栓106使压电元件100在第一共振器92和第二共振器94之间保持压缩状态。螺栓106具有螺栓头、螺杆、以及螺纹末端。螺栓106可从第一共振器92的近端插入第一共振器92、电极96和电极98、以及压电元件100的孔。螺栓106的螺纹末端旋入第二共振器94近端中的螺纹孔。螺栓106可由钢、钛、铝、或其他合适的材料制成。例如,螺栓106可由Ti-6A1-4V钛或4037低合金钢制成。
可以根据发生器30提供的电信号对压电元件100提供能量,从而在声波组件中产生声学驻波。该电信号使电磁场穿过压电元件100,从而使压电元件100沿电压梯度的纵向轴线以连续的方式膨胀和收缩,进而产生高频超声能量纵波。超声能量通过声波组件传输至端部执行器180。
声波组件的固定器械84具有近端、远端,并且其长度基本上等于二分之一系统波长的整数倍(nλ/2)。固定器械84的近端可通过靠近波腹的内部螺纹连接轴向对准并连接至第二共振器94的远端。还可设想固定器械84可以通过任何合适的装置连接到第二共振器94,并且第二共振器94和固定器械84可形成单个组件或整体组件。
固定器械84连接至靠近波节的超声驱动单元50的壳体52。固定器械84可包括设置在其周边的整体固定法兰108。固定法兰108可设置在形成于超声驱动单元50的壳体52中的环形凹槽110内,以便将固定器械84连接至壳体52。适形构件或材料112(例如通过垫片连接的一对硅橡胶O形环)可设置于壳体52的环形凹槽110和固定器械86的整体法兰108之间,以便减小或防止超声振动从固定器械84传递至壳体52。
固定器械84可通过多根销114(例如4根)固定在预定的轴向位置。销114以彼此相隔90度的纵向方向设置在固定器械84的外围。销114连接至超声驱动单元50的壳体52,并且穿过固定器械84的声波固定法兰108中的凹口。销114可由不锈钢制成。根据多个实施例,销114可形成为壳体52的整体组件。
固定器械84被构造用于增大通过声学组件传输至端部执行器180的远端的超声振动偏移。在一个实施例中,固定器械84包括实心锥形喇叭。超声能量穿过固定器械84时增大了穿过固定器械84的声波的速度。可以设想将固定器械84构造为任何合适的形状,例如阶梯形喇叭、锥形喇叭、指数曲线形喇叭、一体式增益喇叭等。
固定器械84可声学连接到超声夹持凝固器器械120的第二声波部分。虽然固定器械84的远端可通过靠近波腹的内部螺纹接头连接到第二声波部分的近端,但是也可采用其他连接构造。
图3示出图1所示外科器械的一个实施例的分解图。超声夹持凝固器器械120的近端优选地通过将驱动单元50插入壳体52来接纳并安装至超声驱动单元50的远端,如图2所示。超声夹持凝固器器械120可作为整体单元连接到超声驱动单元50,并且可从超声驱动单元50上移除。超声夹持凝固器120在单次使用后便可丢弃。
超声夹持凝固器器械120可包括手柄组件或壳体130,其可包括配套壳体部分131、132以及细长部分或内窥镜部分150。当本器械被构造用于内窥镜检查时,其构造的尺寸可以使得细长部分或内窥镜部分150具有约5.5mm的外径。超声夹持凝固器器械120的细长部分150的延伸方向可以基本上与器械壳体130垂直。细长部分150可选择性地相对于壳体130旋转,如下文所述。细长部分150可包括外部管状构件或护套160、内部管状致动构件170,以及以包括刀片180′的端部执行器180形式存在的声波系统的第二声波部分。如下文所述,外护套160、致动构件170、以及端部执行器180可接合在一起,以便作为整体单元(与超声驱动单元50一起)相对于壳体130进行分度旋转。
第二声波部分的端部执行器180的近端能够可分离地连接到靠近波腹的超声驱动单元50的固定器械84,如上所述。端部执行器180的长度基本上等于二分之一系统波长的整数倍(nλ/2)。端部执行器180可由实芯轴制成,该实芯轴由能够有效传播超声能量的材料(如钛合金(例如Ti-6A1-4V)或铝合金)制成。作为另外一种选择,可以设想端部执行器180可由任何其他合适的材料制成。
如上所述,端部执行器180可包括波导管181。波导管181可以基本上为半柔性的。作为另外一种选择,公认的是波导管181可以基本上为刚性的或可以包括软线。如本领域中所熟知的,波导管181可被构造用于增大通过波导管传输至刀片的机械振动。波导管181还可具有控制沿波导管181的纵向振动增益的结构,并且具有将波导管调谐至系统共振频率的结构。
公认的是端部执行器180可具有任何合适的横截面尺寸。例如,端部执行器180可具有基本上均匀的横截面,或者端部执行器180可在多个截面处渐缩或可沿其整个长度渐缩。
参见图3,所示的端部执行器180的波导管181部分包括第一部分182、第二部分184、以及第三部分186。第一部分182可从端部执行器180的近端向远端延伸,并且具有基本上连续的横截面尺寸。第一部分182可包括至少一个径向洞或小孔188,该径向洞或小孔在第一部分中沿直径延伸,并且基本上垂直于端部执行器180的轴线。小孔188可设置在波节处,但也可设置在其他部位。公认的是小孔188可具有任何合适的深度以及任何合适的形状。小孔188被构造用于接纳连接器销构件,该构件将波导管181、管状致动构件170以及管状外护套160连接在一起,以便相对于器械壳体130进行联合分度旋转。
波导管181的第二部分184从第一部分182向远端延伸。第二部分184优选地也具有基本上连续的横截面。第二部分184的直径可以小于第一部分182的直径并且大于第三部分186的直径。当超声能量从端部执行器180的第一部分182进入第二部分184时,第二部分184变窄将导致穿过其中的超声能量的幅值增加。
第三部分186从第二部分184的末端向远端延伸。第三部分186也优选地具有基本上连续的横截面。第三部分186还可沿其长度具有小的直径变化。根据多个实施例,第二部分184向第三部分186的过渡可位于波腹处,以使得第三部分的直径变化不会引起幅值的增加。
第三部分186的周围可以形成多个凹槽或凹口(未示出)。这些凹槽可位于端部执行器180的波节处,以便在制造过程中作为安装阻尼护套(未示出)并且固定硅胶环或适形支架的对准指示器。可在最远端的波节处(离刀片180′最近处)提供密封件以减少波导管与致动构件170之间的区域中组织、血液和其他物质的流通。
端部执行器180的刀片180′可与之形成整体并构成单个单元。刀片180′可由螺纹接头或焊接节点交替连接。根据多个实施例,刀片180′在机械性方面可以为锋利或钝的。刀片180′的远端设置在靠近波腹处,以便在声学组件未承载组织时将其调谐至优选的共振频率f0。当为换能器组件提供能量时,刀片180′的远端被构造为以预定的振动频率f0在(例如)峰到峰间距离为约10至500微米范围内、优选地约10至约100微米的范围内纵向运动。
根据图示的实施例,刀片180′可为圆柱形以配合夹持凝固器120的相关夹紧机构。可以对端部执行器180进行合适的表面处理,如本领域中所知。
图4示出可与图1所示外科器械一同使用的夹紧机构的一个实施例。夹紧机构可被构造用于与端部执行器180的刀片配合使用。该夹紧机构包括可枢转运动的夹臂190,该夹臂从其远端可枢转地连接至外部管状护套160的远端。夹臂190包括夹臂组织垫192,该夹臂组织垫优选地由
Figure BSA00000681167200131
或其他合适的低摩擦材料形成,安装夹臂组织垫以便与刀片180′配合,而夹臂190的枢转运动使夹持垫192基本上与刀片180′平行并且与之接触。通过此构造,待夹持的组织被夹在组织垫192和刀片180′之间。组织垫192可具有锯齿状构造,该构造包括多个轴向间隔的向近端延伸的夹齿197,以便与刀片180′配合加强对组织的夹持。
夹臂190相对于刀片180′的枢转运动通过在其近端提供至少一个、优选的是一对夹臂190的杠杆部分193来实现。杠杆部分193设置在端部执行器180和刀片180′各自的相对侧,并且与往复致动构件170的驱动部分194可操作地接合。致动构件170相对于外部管状护套160和端部执行器180往复运动,从而使夹臂190相对于刀片180′枢转运动。杠杆部分193可分别设置在由驱动部分194限定的一对开口中,或者与该开口进行适当的机械连接,由此致动构件170的往复运动通过驱动部分194和杠杆部分193作用以使得夹臂190枢转运动。
图5示出图1所示外科器械的一个实施例的剖视图,而图6示出图1所示外科器械的一个实施例的各种内部组件。图7示出驱动托架的一个实施例,并且图8示出图1所示外科器械的驱动箍的一个实施例。在图3和图5至图8所示的实施例中,致动构件170的往复运动通过提供驱动箍200来实现,该驱动箍安装在致动构件170近端以便进行联合旋转。驱动箍200可包括一对沿直径对置的轴向延伸臂202,各臂202具有驱动突缘204,其中驱动突缘204经臂202偏压而与管状致动构件170的近端部分限定的适当开口206接合。驱动箍200与致动构件170的共同旋转还可通过提供一对键208来实现,键208与致动构件170的近端部分限定的适当开口210沿直径接合。致动构件170上的周向凹槽211内包括O形环211′(图3)以便与外护套160的内表面接合。
致动构件170与外部管状护套160和内端部执行器180的共同旋转由穿过器械120的这些组件的连接器销212来实现。管状致动构件170限定细长狭槽214,连接器销212延伸穿过细长狭槽214,以便配合致动构件相对于管状护套和内部波导管的往复运动。
安装在外部管状护套上的旋钮216有利于相对于夹持凝固器器械120的壳体130对细长部分150进行旋转定位。连接器销212优选地将旋钮216与护套160、构件170、以及端部执行器180连接在一起,以便作为整体单元相对于壳体130旋转。在该实施例中,旋钮216的轮毂部分216′的作用是将外护套160、致动构件170、以及端部执行器180(与旋钮216一起作为整体单元)可旋转地固定在壳体130上。
驱动箍200提供器械120的夹持驱动机构的一部分,这通过致动构件170的往复运动实现了夹臂190的枢转运动。该夹持驱动机构还包括与操纵杆222可操作地连接的驱动托架220,从而使该操纵杆通过驱动托架220和驱动箍200与往复致动构件170互连。操纵杆222(通过枢转安装座223)可枢转地连接至器械的壳体130,以便以剪刀状形式与壳体的握柄部分224相配合。操纵杆222朝握柄部分224的运动使致动构件170向近端平移,从而使夹臂190向刀片180′枢转。
驱动托架220与操纵杆222的可操作性连接通过弹簧226提供,优选地包括压缩螺旋弹簧226。弹簧226安装在由驱动托架220限定的弹簧狭槽228内,驱动托架又设置在操纵杆222的一对弹簧挡圈230之间。驱动托架220可以相对于与压缩螺旋弹簧相对的弹簧挡圈230(在壳体130的枢轴安装座223周围)枢转运动,该压缩螺旋弹簧挤压由各个弹簧挡圈230限定的弹簧狭槽的表面。这样,由操纵杆222的枢转运动通过驱动托架220和驱动箍200施加到致动构件170的力会受到弹簧226挤压弹簧挡圈230的力的限制。施加过大的力会使驱动托架220相对于与弹簧226相对的操纵杆222的弹簧挡圈230产生枢转位移。壳体130的止动部分限制操纵杆222的移动,从而防止弹簧226的过度压缩。在多个实施例中,施加到致动构件170上的力可以由可操作地设置在驱动箍200和构件170之间的一个或多个弹簧(未示出)所限制。例如,可使用一个或多个圆柱形弹簧,例如波形弹簧。以此方式利用波形弹簧的一个示例性实施例描述于美国专利No.6,458,142中,该专利以引用方式并入本文中。
本文的夹持凝固器器械120的细长部分150的分度旋转定位可通过提供结合在器械120的夹持驱动机构中的定位机构来实现。具体地讲,驱动箍200可包括一对轴向间隔的驱动法兰232。定位接纳表面可设置在驱动法兰232之间,并且可限定多个周向间隔的齿234。齿234可限定通常围绕驱动箍200的周边的定位接纳凹槽。在图7所示的实施例中,提供了12个齿234,从而相对于设备的壳体130对设备的细长部分150每隔30°进行分度定位。
分度旋转运动还可通过提供至少一个、优选的是一对沿直径对置的定位槽236来实现,定位槽分别设置在驱动托架220的悬臂式托架臂238上。通过这种构造,将托架臂238设置在驱动法兰232之间以便与其相对的表面接合,并且将定位槽236偏置以使其与驱动箍200接合。托架臂238的定位槽236与驱动法兰238相配合,使致动构件170进行往复运动,从而实现分度相对旋转。根据多个实施例,驱动托架220可由合适的聚合材料形成,其中由托架臂238产生的偏置力作用在与驱动箍限定的径向凹槽配合的托架臂的定位槽236上,以便抵抗小于约5至20英寸-盎司的相对旋转扭矩。因此,将夹持凝固器器械120的细长部分150相对于壳体130维持在其选定的分度旋转位置的任何一个位置,除非施加的扭矩(例如通过旋钮216)超过此预定的扭矩水平。因此提供了按扣状分度作用。
本文的夹持凝固器器械120的细长部分150的旋转可以与超声驱动单元50相对于壳体130的相对旋转运动一同实现。为了将细长部分150以超声传输关系接合至超声驱动单元50,可以使外部管状护套160的近端部分具有一对扳手平面240(图3)。合适的转矩扳手等可通过该扳手平面施加扭矩,从而使端部执行器180接合至超声驱动单元50。因此,通过适当操纵旋钮216可以使超声驱动单元50以及细长部分150作为整体单元相对于设备的壳体130旋转。壳体130的内部尺寸被设计为可以配合驱动单元50的这种相对旋转。
图9示出包括外科器械251的外科系统250的一个实施例,该外科系统具有单元件端部执行器256。该系统250可包括连接到端部执行器256的换能器组件252,以及设置在所示端部执行器256的近端部分周围的护套254。换能器组件252和端部执行器256可以与上述换能器组件50和端部执行器180相似的方式工作,从而产生可通过刀片256′传输至组织的超声能量。
图10示出外科器械1000的一个实施例的框图,该手术器械可以配置成具有温度反馈功能。例如,控制电路1002可以根据端部执行器1008振动频率的变化调节发生器1004向换能器1006提供的电信号的电流幅值。根据多个实施例,当端部执行器1008振动频率降低时,可以减小电信号的幅值。这可以使外科器械1000将端部执行器1008保持在相对恒定的温度,从而使器械1000的性能更加稳定。
如上所述,在外科手术过程中,端部执行器1008可以接触组织并振动,以便切割和/或凝固组织。出现这种情况时,端部执行器1008与组织之间的摩擦会使端部执行器1008的温度升高。当端部执行器1008的温度升高时,其材料性质会发生变化,从而使手术器械1000整体发生变化。例如,当端部执行器1008的温度升高时,端部执行器1008的位移与电信号的电流幅值之间的关系会发生变化,使得在电流幅值不会相应增加的情况下,端部执行器1008的位移增加。此外,当端部执行器1008的温度升高时,端部执行器1008的共振频率会降低。例如,端部执行器1008的材料性质变化会降低器械1000的共振频率。因此,发生器1004会降低电驱动信号的频率,从而导致端部执行器1008的驱动振动频率相应降低。
控制电路1002可以监控发生器1004提供的电信号。如上所述,电信号频率的降低可以表明端部执行器1008的温度升高及其位移增加。当控制电路1002感测到电信号频率降低时,可以命令发生器1004减小电信号的电流幅值。电信号的电流幅值可以适当降低,以使得端部执行器1008的频率基本上保持恒定,从而使端部执行器1008的温度基本上恒定。补偿给定频率变化所需的电流幅值变化量可通过任何合适的实验或理论方法确定。
应当理解,器械1000在外形上可以为任何合适的超声器械或系统,包括(例如)上述系统10和250。控制电路1002可以为任何合适的模拟电路或数字电路。例如,控制电路1002可以包括处理器,例如数字信号处理器(DSP)。
作为上述温度反馈功能的补充或替代形式,图10所示器械1000的一个实施例可以被构造用于检测空蚀,其中声学空蚀信号从组织传送到端部执行器1008。这可以为临床医生提供关于组织状态的信息。例如,在组织脱水之前,可以通过蒸发或沸腾除去组织内的几乎全部水分。当水分蒸发或沸腾时,可以在组织内产生空蚀。如果能检测到这种空蚀的存在,器械1000就可以让临床医生了解已经或将要使组织脱水。切割和/或凝固过程中发生的其他组织转变可以通过多种其他空蚀来反映。
与端部执行器1008接触的组织(和/或组织内包含的流体)所产生的组织空蚀会影响端部执行器1008的振动,进而影响发生器1004和换能器1006之间的电信号。如上所述,压电元件(未示出)可以因对电荷的响应而产生运动。此外,压电元件可以相反的方式工作,即因对运动的响应而产生和/或改变电荷。因此,传送到端部执行器1008的组织空蚀可以继而传送到换能器1006的压电元件。这会使压电元件产生电荷,这些电荷可以按照与组织空蚀成比例的方式改变发生器1004与换能器1006之间的电信号。由于组织空蚀而隔离部分电信号可以表明组织空蚀的存在,并且反映出一个或多个主频率以及其他信息。
由于组织空蚀的存在,可以任何合适的方式隔离电信号的一部分。例如,控制电路1002可包括滤波器电路(未示出),用来滤除电信号中的驱动频率及其任何谐波。电信号的剩余部分可能是因组织空蚀所引起。滤波器电路可以包括任何合适的模拟滤波器或数字滤波器。
许多组织空蚀持续时间相对较短,因而具有相对较宽的频谱。因此,组织空蚀在任何截然不同的频率下可能并不明显,并且反而可以在其共振频率(如振动频率)及其谐波下激发端部执行器1008。为了解决这种问题,控制电路1002可以包括处理器或其他功能,以将该电信号与端部执行器1008未负载或不接触组织时测得的对照电信号进行比较。测得的电信号与对照电信号之间的差值可以反映出组织空蚀的存在。当控制电路1002感测到组织空蚀的存在时,可以使用任何合适的方法将该情况告知临床医生,这些方法包括(例如)使用光、显示器和/或声音信号。
图11示出描述外科器械的一个实施例的实例测试结果的图1100。在实例测试中,外部空蚀通过分析换能器与端部执行器之间的电信号的频谱来识别。测试过程中,在额定驱动频率55.5kHz下,将LCS14C端部执行器与HP054换能器和GEN 300发生器结合使用。所有这些组件均可得自Ethicon Endo Surgery,Inc。在空气中以5级功率设置为端部执行器提供能量并持续100毫秒,以进行对照实验。在此期间,使用AGILENT 5483D型示波器(AGILENT Oscilloscope Model 5483D)监控换能器与发生器之间的电信号。对于每次实验研究,都将端部执行器放入装有400cc新鲜自来水的塑料烧杯中。然后以给定功率电平为端部执行器提供能量并持续100毫秒,同时用示波器监控换能器与发生器之间的电信号。三次实验研究分别在发生器设置为1、3和5的情况下进行。
图1100示出对照实验和实验研究过程中在驱动频率以及驱动频率的两个谐波下观察到的电信号中低Q峰的幅值。线1102示出55.5kHz的驱动频率,线1104示出45kHz下的第一谐波,线1106示出63kHz下的第二谐波。可以看出,在驱动频率下实验研究过程中的低Q峰的幅值明显高于对照实验过程。同样,在谐波下实验研究过程中的低Q峰的幅值也更高。据信,驱动频率1102以及谐波1104和1106下幅值的增加是由于端部执行器的振动释放出自来水中溶解的气体而造成空蚀的结果。为了支持上述结论,应当指出的是,当各个实验所用的自来水相同时,低Q峰值明显较小,这说明所有溶解的气体都已释放。当端部执行器遇到组织空蚀时,在器械的驱动频率和谐波频率下低Q峰值中会出现类似的效应。
作为上述功能的补充或替代形式,图10所示的器械1000可具有监控端部执行器1008的频率变化的功能。例如,控制电路1002可以通过监控端部执行器的振动频率来检测变化。端部执行器频率的变化可以反映接触端部执行器的组织的变化。图12示出描述在凝固和切割过程中端部执行器频率1202和端部执行器温度1204之间关系的图1200。横轴1201表示时间,纵轴1203对于曲线1204表示温度,对于曲线1202则表示端部执行器的振动频率。垂线1206表示组织凝固(如上文所述的胶原变性)的大致起点。垂线1208表示脱水和初始横断面的大致起点。
在图1200所示的切割/凝固过程中,温度曲线1204递增。在凝固开始1206之前,温度曲线1204急剧上升。在凝固1206和脱水1208之间,温度-时间曲线1204的斜率减小。在脱水1208之后,温度曲线1204再次开始更加急剧地上升。端部执行器的频率曲线1202可以为温度曲线1204的镜像。例如,频率曲线1202可以在凝固开始1206之前快速下降。在凝固开始1206处,频率曲线1202继续下降,但降速趋缓,显示出拐点特征1210。在脱水开始1208附近,频率曲线1202将开始更加急剧地下降。
根据多个实施例,可以对控制电路1002进行编程,以识别频率曲线1202下降速率的变化,进而反映组织开始凝固的时间和开始脱水的时间。在一个实施例中,控制电路1002可以监控发生器1004与换能器1006之间的电信号频率,从而监控端部执行器1008的振动频率。应当理解,这两个频率可以相同。当控制电路1002感测到端部执行器频率的下降速率已经减小(如曲线1202已到达拐点特征1210)时,控制电路1002可以指示出凝固已经开始。当控制电路1002感测到端部执行器频率的下降速率已经再次升高时,则可以指示出脱水开始。器械1000可根据任何合适的方法为临床医生提供多种指示,这些方法包括(例如)光、显示器和声音信号。根据多个实施例,控制电路1002可以根据向凝固或脱水的转变切断端部执行器1008的能量供给或减小其幅值。这样临床医生就可以在凝固和/或脱水之前检查组织,确保手术圆满进行。
根据多个实施例,图10的器械1000可以将频率变化功能与组织空蚀感测功能结合起来,以指示接触端部执行器1008的组织的状态。例如,虽然图12所示的频率曲线1202在凝固开始1206处示出拐点特征1210,但其频率变化速率在脱水开始1208处会变得更加平缓。因此,很难通过单独监控端部执行器的频率准确地识别脱水开始1208。另一方面,组织空蚀在脱水开始1208附近最为常见。例如,当水分离开组织时会剧烈沸腾,从而产生空蚀。因此,如上所述,控制电路1002可以被配置为通过识别端部执行器的频率曲线1202的拐点1210来识别凝固开始1206。此外,控制电路1002可以被配置为通过识别组织空蚀(例如结合端部执行器频率曲线1202下降速率的增加)来识别脱水开始1208。同样,器械1000可根据任何合适的方法为临床医生提供多种指示,这些方法包括(例如)光、显示器和声音信号。此外,如上所述,可以根据向凝固或脱水的转变切断器械1000的能量供给,或降低端部执行器1008的振动频率。
图13示出外科器械1300的一个实施例的框图,该手术器械被配置为根据胶原变性系数(CCD)得到端部执行器反馈。CCD可以表示端部执行器1308与一部分组织(未示出)之间的摩擦量。通过分析由切割和/或凝固手术过程获得的CCD曲线,可以得到有关切割和凝固进程的信息,以及有关组织部分的信息,包括(例如)组织部分的厚度和外径。
根据多个实施例,可以将CCD作为变量的函数计算,例如,包括:(i)向端部执行器1308提供的功率;(ii)端部执行器1308的振动频率;(iii)端部执行器1308在周期内的位移;以及(iv)施加在夹紧机构1310与端部执行器之间的组织区域的夹紧力。夹紧机构1310本身可以为任何合适的机构,用于夹持或以其他方式施加力使组织区域紧压在端部执行器上。根据多个实施例,夹紧机构1310可以类似于上述夹紧机构190。通过器械1300的控制电路1302可以得出上述变量随时间变化的值。例如,根据在端部执行器1308承受载荷(如接触组织区域)时发生器1304与换能器1306之间的电信号,可以得出向端部执行器1308提供的功率。端部执行器1308每周期的位移可以为电信号的电流幅值的函数。此外,如上所述,端部执行器1308的振动频率可以基本上等同于电信号的频率。
端部执行器1308与夹紧机构1310的夹紧力可以根据任何合适的方法得出。例如,根据多个实施例,夹紧机构1310可以由电动机驱动。例如,参见图2所示的实施例,往复致动构件170可以通过电动机1312在远端和近端之间来回移动。在该实施例中,夹紧机构1310和端部执行器1308之间的夹紧力可以由提供给电动机1312的驱动电信号得出。例如,驱动电信号的电流幅值可以指示夹紧力。根据多个实施例,夹紧力可以由与控制电路1302连通的传感器1314得出。传感器可以放置在与端部执行器1308、夹紧机构1310和/或器械手柄的一部分(图13中未示出)连通的任何合适位置。图4所示的实施例示出设置在夹臂组织垫192和夹臂190之间的传感器1316的一个实例。此外,图2所示的实施例示出设置在操纵杆222的一部分和驱动箍200之间的传感器1318。在一个实施例中,夹紧力可以视为常数,并且将其作为CCD计算中的因素。
器械1300可以利用CCD曲线感测该部分组织进入凝固和脱水阶段的时间。图14示出描述整个凝固和切割转变过程中的CCD曲线1402的图。CCD曲线1402可以用具有实芯端部执行器的超声器械获得,该端部执行器由得自Ethicon Endo Surgery,Inc的GEN03发电装置供电。该发电装置的功率设置为三(3)级;端部执行器1408的位移设为55微米;端部执行器的振动频率设置在55.5kHz;采用2磅的夹紧力。曲线1402可分为三个区域。第一区域1408可以对应于凝固开始1404之前的时间,并且可以具有基本上为负的斜率。第二区域1410可以对应于凝固开始1404与脱水开始1406之间的时间,并且具有基本上为零的斜率。第三区域1412可以对应于脱水开始1406之后的时间,并且可以具有基本上为正的斜率。根据多个实施例,控制电路可以监控CCD曲线1402的斜率,以确定组织部分的状态。可以根据任何合适的方法为临床医生指向凝固或脱水的转变,这些方法包括(例如)光、显示器和/或声音信号。此外,如上所述,控制电路1302可以根据向凝固或脱水的转变切断端部执行器1308的能量供给。
控制电路1302也可以利用CCD曲线1402确定组织部分的其他特征,包括(例如)组织部分的外径和厚度。应当理解,该组织部分可以为组织的实心部分,或者可以限定腔(如动脉、静脉或其他管状组织)。图15示出描述胶原变性系数曲线1502的图。采用具有实芯端部执行器的超声器械,通过颈动脉的凝固和脱水过程得出曲线1502,该端部执行器由GEN03发电装置供电。发电装置的功率设为五(5)级。端部执行器1408的位移设为55微米;端部执行器的振动频率设为55.5kHz;采用2磅的夹紧力。CCD曲线1502分为9个具有基本上恒定斜率的区域:1504、1506、1508、1510、1512、1514、1516、1518和1520。
CCD曲线1402的9个区域中每个部分的多种特性可以与组织部分的特性(例如外径和厚度)相关。在一个示例实验中,采用具有实芯端部执行器的超声器械对14根不同直径的颈动脉进行凝固和切割,其中端部执行器由GEN03发电装置供电。下表1示出颈动脉的“外径”和“壁厚”,以及所用的“夹紧力”和“功率电平”。“多项式拟合”列示出每次实验中CCD曲线的第一区域1504的多项式拟合指数。“归一化CCD值”示出每次实验的CCD值,该值通过用各个CCD值除以第一区域1504末端的CCD值进行归一化处理。
表1
  实验   夹紧力   功率电平   外径(英寸)   壁厚   多项式拟合   归一化CCD值
  1   0.4   3   0.169   0.042   .0181   1.2826
  2   1   3   0.169   0.042   0.254   *
  3   0.4   5   0.117   0.04   0.227   *
  4   1   5   0.117   0.04   0.251   *
  5   0.4   4   0.146   0.042   0.251   1.16738
  6   1   4   0.146   0.042   0.361   1.47
  7   0.4   4   0.136   0.05   0.266   1.14
  8   1   4   0.136   0.05   1.231   1.23
  9   0.7   3   0.094   0.045   1.765   1.05
  10   0.7   5   0.094   0.045   0.744   1.35
  11   0.7   3   0.156   0.045   0.15   1.1
  12   0.7   5   0.156   0.045   0.214   1.49
  13   0.7   4   0.119   0.035   0.791   1.27
  14   0.7   4   0.119   0.035   0.295   1.23
图16显示了一系列曲线1602、1604、1606和1608,这些曲线描述表1所示实验中的CCD曲线第一区域第一点的归一化值与夹紧力、功率电平、外径和壁厚之间的关系。曲线1602、1604、1606和1608的斜率可以反映对应变量与CCD曲线第一区域第一点的归一化值之间的相关度。可以看出,曲线1602、1604、1606和1608均具有非零斜率,因此其所有对应变量均与CCD曲线相关。可以用数学模型(例如二次模型)拟合实验结果(例如表1中所示的结果),以得出一个或多个方程,这些方程可以反映出CCD曲线第一区域第一点的归一化值与夹紧力、功率电平、外径和壁厚之间的关系。
参见图13所示的实施例,控制电路1302可以监控当器械1300凝固和/或切割组织部分时生成的CCD曲线。识别出CCD曲线上具有基本相同的斜率的区域之后,控制电路1302可以得出描述该区域的特性,包括(例如)该区域的斜率、曲线在该区域的归一化值和/或第一区域的长度。控制电路1302可以得出该组织部分的特性,包括(例如)该组织部分的外径或该组织部分的厚度。可以根据任何合适的方法得出组织特性。例如,可以构建(例如)如上所述将区域特性与组织特性相关的数学模型。控制电路1302可以利用预定的数学模型使区域特性与组织特性相关。此外,根据多个实施例,可以生成有关区域特性和组织特性之间关系的查找表。
图17示出用于外科器械的端部执行器1700的一个实施例,该外科器械包括径向模式换能器1702、1704和1706。当被电信号(例如来自发生器)激发时,径向模式换能器1702、1704和1706可以产生垂直于纵向轴线1710的超声振动。超声振动在换能器1702、1704和1706的径向表面具有波腹。因此,端部执行器1700的整个径向表面都可以被激活,以便凝固和切割组织。中央构件1708可以沿纵向轴线1710延伸,并且可以充当部分或全部径向模式换能器1702、1704和1706的电极。此外,径向模式换能器1702、1704和1706的外径向表面可以涂覆导电物质,或者作为另外一种选择,可以用金属管状护套封装,两种情况下都可以作为电极。虽然图中示出多个换能器1702、1704和1706,但应当理解,一些实施例也可以只包括一个径向模式换能器。
图18示出图17的端部执行器1700的一个实施例,该端部执行器安装在包括夹臂1802的外科器械1800上。图中示出了附加的径向模式换能器1701和1703,但应当理解,可以使用任何合适数量的换能器。夹臂1802可以可枢转地向端部执行器1700移动,其方式类似于图4所示的实施例中夹臂190可枢转地向端部执行器180移动的方式。根据多个实施例,端部执行器1700的中央构件1708具有柔韧性。这样多个径向模式换能器1702、1704和1706就可以相对于彼此挠曲。图19示出图17的端部执行器1700的一个实施例,其中中央构件1708具有柔韧性。中央构件1708的柔韧性使得不同径向模式换能器(此处为1704和1706)可以相对彼此挠曲,从而使端部执行器1700既柔韧又可以关节运动。端部执行器1700的关节运动可以通过任何合适的方式获得。例如,柔韧的中央构件1708可以限定中央腔(未示出)。金属线(未示出)可以在中央构件1708内中央腔的相对侧上移动。可以利用器械手柄部分附近的关节运动把手或其他关节运动工具收缩其中一个金属线。当金属线收缩时,会使柔韧的中央构件1708以及端部执行器1700在收缩的金属线方向上关节运动。例如,如果收缩中央构件1708右侧的线,则端部执行器1700可以向右侧关节运动。应当理解,这只是关节运动机构的一个实例,并且可以使用任何合适的关节运动方法。
图20至21示出图17的端部执行器1700的一个实施例,该端部执行器包括限定凹陷2004的换能器2002。换能器2002可以利用凹陷2004将超声能量导向不直接接触换能器2002或端部执行器1700的组织。例如,换能器2002的凹陷可以用于将超声能量聚集到点2006。根据多个实施例,凹陷2004可以在换能器2002周围径向延伸,如图21中的实施例所示。因此,焦点2006在换能器2002周围径向延伸并形成圆环面。
本文所公开的器械可被设计为单次使用后丢弃,或者它们可被设计为可使用多次。然而在任一种情况下,该器械均可重新恢复,从而在至少一次使用后再次使用。重新恢复可包括如下步骤的任意组合:拆卸该器械、然后清洗或更换某些元件、以及随后组装。具体地讲,器械可以拆卸,并且可以任何组合选择性地更换或移除器械中任意数目的某些元件或组件。清洗和/或更换某些组件后,该器械可以在重新恢复设施处重新组装以随后使用,或者在即将进行外科手术操作前由外科手术队组装。本领域的技术人员将会知道,修复器械时可利用多种技术进行拆卸、清洗/更换和重新组装。这种技术的使用以及所得的修复器械均在本发明的范围内。
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。然后对器械进行消毒。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
Figure BSA00000681167200251
口袋中。然后将容器和器械置于可穿透该容器的辐射场,例如γ辐射、X射线或高能电子。辐射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,直到在医疗设备中打开该容器。
优选的是在外科手术前对器械进行消毒。这可以通过任意数目的本领域技术人员已知的方式来进行,包括β辐射、γ辐射、环氧乙烷、蒸汽。
虽然本文已描述了各种实施例,但可以对这些实施例进行多种修改和变型。例如,可采用不同类型的端部执行器。此外,虽然其中公开了某些组件用的材料,但也可使用其他材料。上述说明书和下述权利要求书旨在涵盖所有此类修改形式和变型。
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。如果任何材料或材料的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 (43)

1.一种外科器械,包括:
换能器,所述换能器用于在驱动频率下接收来自发生器的电信号,并且所述换能器用于在所述驱动频率下提供振动;
端部执行器,所述端部执行器连接到所述换能器并且沿纵向轴线从所述换能器延伸;以及
控制电路,所述控制电路用于检测对所述端部执行器的振动频率的第一贡献,所述第一贡献来自于与所述端部执行器接触的组织。
2.根据权利要求1所述的外科器械,还包括用于从所述振动频率中滤除所述驱动频率的滤波器电路。
3.根据权利要求1所述的外科器械,还包括用于从所述振动频率中滤除所述驱动频率的至少一个谐波的滤波器电路。
4.根据权利要求1所述的外科器械,其中所述控制电路还用于将所述外科器械的所述振动频率和所述端部执行器不与组织接触时所述端部执行器的未负载振动频率进行比较。
5.一种用于控制外科器械的方法,包括:
获得根据权利要求1所述的外科器械;以及
对所述控制电路进行编程,以便检测对所述端部执行器的振动频率的第一贡献,所述第一贡献来自于与所述端部执行器接触的组织。
6.一种用于控制外科器械的方法,其包括:
监控外科器械的端部执行器的振动频率;以及
识别对所述振动频率的第一贡献,所述第一贡献来自于与所述端部执行器接触的组织。
7.一种包括处理器的外科器械,其中对所述处理器进行编程以便执行以下操作:
监控外科器械的端部执行器的振动频率;以及
识别对所述振动频率的第一贡献,所述第一贡献来自于与所述端部执行器接触的组织。
8.根据权利要求7所述的外科器械,其中所述处理器用于从所述振动频率中滤除所述端部执行器的驱动频率。
9.根据权利要求7所述的外科器械,其中所述处理器用于将所述振动频率和所述端部执行器不与组织接触时所述端部执行器的未负载振动频率进行比较。
10.一种用于控制外科器械的方法,包括:
获得根据权利要求7所述的外科器械;
对所述处理器进行编程,以便监控所述外科器械的端部执行器的振动频率;并且识别对所述振动频率的第一贡献,所述第一贡献来自于与所述端部执行器接触的组织。
11.一种外科器械,包括:
换能器,所述换能器用于提供振动;
端部执行器,所述端部执行器连接到所述换能器并且沿纵向轴线从所述换能器延伸;以及
控制电路,所述控制电路用于指示所述端部执行器的振动频率的变化。
12.根据权利要求11所述的外科器械,其中所述控制电路用于指示所述振动频率下降速率的减小。
13.根据权利要求11所述的外科器械,其中所述控制电路用于指示所述振动频率下降速率的增加。
14.根据权利要求11所述的外科器械,其中所述控制电路用于检测对所述振动频率的第一贡献,所述第一贡献来自于与所述端部执行器接触的组织。
15.一种处理外科器械的方法,所述方法包括:
获得根据权利要求11所述的外科器械;以及
对所述控制电路进行编程,以便指示所述端部执行器的振动频率的变化。
16.一种用于控制外科器械的方法,其包括:
监控外科器械的端部执行器的振动频率;
识别所述振动频率下降速率的减小;以及
响应于所述减小来指示凝固的开始。
17.一种包括处理器的外科器械,其中对所述处理器进行编程以便执行以下操作:
监控外科器械的端部执行器的振动频率;
识别所述振动频率下降速率的减小;以及
响应于所述减小来指示凝固的开始。
18.根据权利要求17所述的外科器械,其中对所述处理器进行编程,以便识别对所述振动频率的第一贡献,所述第一贡献来自于与所述端部执行器接触的组织;并且响应于所述第一贡献来指示脱水的开始。
19.根据权利要求18所述的外科器械,其中所述处理器用于在指示所述脱水开始之前指示所述凝固是否开始。
20.根据权利要求17所述的外科器械,其中所述处理器用于识别所述振动频率下降速率的增加;并且响应于所述增加来指示脱水的开始。
21.一种处理外科器械的方法,包括:
获得根据权利要求17所述的外科器械;
对所述处理器进行编程,以便监控所述外科器械的端部执行器的振动频率;识别所述振动频率下降速率的减小;并且响应于所述减小来指示凝固的开始。
22.一种外科器械,包括:
换能器,所述换能器用于提供振动;
端部执行器,所述端部执行器连接到所述换能器并且沿纵向轴线从所述换能器延伸;
夹紧机构,所述夹紧机构能够向所述端部执行器平移;以及
控制电路,所述控制电路能够用于根据下列因素计算表示胶原变性系数随时间变化的曲线:
由所述端部执行器向部分组织传输的功率;
施加到所述端部执行器与所述夹紧机构之间的部分组织上的夹紧力;
所述端部执行器的位移;以及
所述端部执行器的振动频率。
23.根据权利要求22所述的外科器械,其中所述胶原变性系数由下式表示:
CCD ~ P CF × D × f
其中:
CCD为所述胶原变性系数;
CF为施加到所述端部执行器与所述夹紧机构之间的部分组织上的夹紧力;
D为所述端部执行器的所述位移;以及
f为所述端部执行器的所述振动频率。
24.根据权利要求22所述的外科器械,其中所述控制电路能够用于:
识别所述曲线的斜率从基本为负的斜率到基本为零的斜率的第一变化;以及
响应于所述第一变化来指示组织凝固的开始。
25.根据权利要求24所述的外科器械,其中所述控制电路能够用于:
识别所述曲线的所述斜率从基本为零的斜率到基本为正的斜率的第二变化;以及
响应于所述第二变化来指示组织脱水的开始。
26.根据权利要求23所述的外科器械,其中所述控制电路能够用于:
识别具有基本上恒定的斜率的所述曲线的第一区域;
计算描述所述第一区域的区域特性,其中所述区域特性选自由下列特性组成的组:所述第一区域的斜率、所述第一区域的长度和所述第一区域内所述曲线的归一化值;以及
根据所述区域特性得出与所述端部执行器接触的部分组织的组织特性,其中所述组织特性选自由所述部分组织的外径和所述部分组织的厚度组成的组。
27.根据权利要求26所述的外科器械,其中所述控制电路能够用于通过查询与所述区域特性和所述组织特性有关的查找表得出所述部分组织的所述组织特性。
28.一种处理外科器械的方法,包括:
获得根据权利要求22所述的外科器械;以及
对所述控制电路进行编程,以便根据下列因素计算表示胶原变性系数随时间变化的曲线:
由所述端部执行器向部分组织传输的功率;
施加到所述端部执行器与所述夹紧机构之间的所述部分组织上的夹紧力;
所述端部执行器的位移;以及
所述端部执行器的振动频率。
29.一种用于控制外科器械的方法,其包括:
监控外科器械的端部执行器向部分组织传输的功率;
监控施加到所述端部执行器与所述夹紧机构之间的所述部分组织上的夹紧力;
监控所述端部执行器的位移;
监控所述端部执行器的振动频率;以及
根据下列因素计算表示胶原变性系数随时间变化的曲线:
所述端部执行器向所述部分组织传输的所述功率;
施加到所述部分组织上的所述夹紧力;以及
所述端部执行器的所述位移;以及
所述端部执行器的所述振动频率。
30.一种包括处理器的外科器械,其中对所述处理器进行编程以便执行以下操作:
监控外科器械的端部执行器向部分组织传输的功率;
监控施加到所述端部执行器与所述夹紧机构之间的所述部分组织上的夹紧力;
监控所述端部执行器的位移;
监控所述端部执行器的振动频率;以及
根据下列因素计算表示胶原变性系数随时间变化的曲线:
所述端部执行器向所述部分组织传输的所述功率;
施加到所述部分组织上的所述夹紧力;以及
所述端部执行器的所述位移;以及
所述端部执行器的所述振动频率。
31.根据权利要求30所述的外科器械,其中所述胶原变性系数由下式表示:
CCD ~ P CF × D × f
其中:
CCD为所述胶原变性系数;
CF为施加到所述端部执行器与所述夹紧机构之间的所述部分组织上的所述夹紧力;
D为所述端部执行器的所述位移;以及
f为所述端部执行器的所述振动频率。
32.根据权利要求30所述的外科器械,其中对所述处理器进行编程以便执行以下操作:
识别所述曲线的斜率从基本为负的斜率到基本为零的斜率的第一变化;以及
响应于所述第一变化来指示组织凝固的开始。
33.根据权利要求32所述的外科器械,其中对所述处理器进行编程以便执行以下操作:
识别所述曲线的所述斜率从基本为零的斜率到基本为正的斜率的第二变化;以及
响应于所述第二变化来指示组织脱水的开始。
34.根据权利要求30所述的外科器械,其中对所述处理器进行编程以便执行以下操作:
识别具有基本上恒定的斜率的所述曲线的第一区域;
计算描述所述第一区域的区域特性,其中所述区域特性选自由下列特性组成的组:所述第一区域的斜率、所述第一区域的长度以及所述第一区域内所述曲线的归一化值;以及
根据所述区域特性得出与所述端部执行器接触的所述部分组织的组织特性,其中所述组织特性选自由所述部分组织的外径和所述部分组织的厚度组成的组。
35.根据权利要求34所述的外科器械,其中所述处理器用于查询与所述区域特性和所述组织特性有关的查找表。
36.一种用于控制外科器械的方法,包括:
获取根据权利要求30所述的外科器械;以及
处理器,所述处理器用于根据下列因素计算表示胶原变性系数随时间变化的曲线:
所述端部执行器向所述部分组织传输的所述功率;
施加到所述部分组织上的所述夹紧力;以及
所述端部执行器的所述位移;以及
所述端部执行器的所述振动频率。
37.一种包括端部执行器的外科器械,所述端部执行器包括:
中央构件,所述中央构件纵向延伸穿过所述端部执行器;以及
多个径向模式换能器,所述多个径向模式换能器设置在所述中央构件周围,其中所述多个径向模式换能器能够用于通过沿垂直于纵向轴线的方向振动而对电信号作出响应。
38.根据权利要求37所述的外科器械,包括能够沿所述纵向轴线向所述多个径向模式换能器枢转的夹臂。
39.根据权利要求37所述的外科器械,其中所述中央构件具有柔韧性。
40.根据权利要求37所述的外科器械,其中所述多个径向模式换能器中的至少一个限定具有垂直于所述纵向轴线的面的凹陷。
41.根据权利要求40所述的外科器械,其中所述凹陷绕所述纵向轴线环绕所述多个径向模式换能器中的至少一个。
42.根据权利要求37所述的外科器械,其中所述端部执行器能够用于关节运动。
43.一种处理外科器械的方法,包括:
获取根据权利要求37所述的外科器械;以及
更换设置在所述中央构件周围的所述多个径向模式换能器中的至少一个,其中所述多个径向模式换能器能够用于通过沿垂直于所述纵向轴线的方向振动而对电信号作出响应。
对所述外科器械进行消毒。
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