CN101765495A - 有效长度增加的超声端部操纵装置 - Google Patents

有效长度增加的超声端部操纵装置 Download PDF

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CN101765495A
CN101765495A CN200880100682A CN200880100682A CN101765495A CN 101765495 A CN101765495 A CN 101765495A CN 200880100682 A CN200880100682 A CN 200880100682A CN 200880100682 A CN200880100682 A CN 200880100682A CN 101765495 A CN101765495 A CN 101765495A
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blade
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acoustic impedance
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CN101765495B (zh
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F·B·斯图伦
K·L·豪瑟
V·P·小巴塔格利亚
B·D·伯克
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Ethicon Endo Surgery Inc
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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
    • 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
    • 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
    • A61B2017/320069Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic for ablating tissue
    • 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
    • A61B2017/320072Working tips with special features, e.g. extending parts
    • 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
    • A61B2017/320072Working tips with special features, e.g. extending parts
    • A61B2017/320078Tissue manipulating surface
    • 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
    • A61B2017/320088Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with acoustic insulation, e.g. elements for damping vibrations between horn and surrounding sheath
    • 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

Abstract

本发明涉及一种端部操纵装置,所述端部操纵装置包括:具有第一声阻抗率值的第一部分和具有第二声阻抗率值的第二部分,所述第二声阻抗率值小于所述第一声阻抗率值。所述第一部分包括所述端部操纵装置的近端段和所述端部操纵装置的远端段,并且所述近端段和所述远端段由第一材料构成。所述第二部分包括所述端部操纵装置的插入段,所述插入段由第二材料构成。所述插入段沿所述端部操纵装置的所述纵向轴线位于所述近端段和所述远端段之间。所述插入段起着跨越或填充所述波节能隙的作用。一种手术器械,所述手术器械包括换能器,所述换能器被配置成以预定频率沿纵向轴线产生振动。一种超声刀片,所述超声刀片沿所述纵向轴线延伸并连接到所述换能器。

Description

有效长度增加的超声端部操纵装置
背景技术
包括空心和实心器械在内的超声器械被用来安全有效地治疗许多病症。超声器械尤其是实心超声器械具有优势,因为它们可以利用以超声频率传输到外科手术端部操纵装置的机械振动形式的能量来切割和/或凝固组织。当用适当的端部操纵装置并以适当的能级传递到有机组织时,超声振动可用来切割、解剖、提升、凝固或烧灼组织,或者用来将肌肉组织与骨骼分离。采用实心技术的超声器械尤其有利,因为超声能量可以从超声换能器经传输元件或波导管传送到外科手术端部操纵装置。这类器械可用于开放性或微创外科手术,例如内窥镜或腹腔镜外科手术,在这些手术中,端部操纵装置经套管针到达手术部位。
以超声频率激活或激发这类器械的单元件或多元件端部操纵装置会引发纵向、横向或扭转振动,其在相邻组织内产生局部热量,从而有利于切割和凝固。由于超声器械的性质,可以将具体的超声致动端部操纵装置设计成执行多项功能,包括(例如)在借助或不借助夹具组件的情况下切割、凝固、刮削或提升组织。
通过(例如)电激励换能器,可以在外科手术端部操纵装置内引发超声振动。换能器可由器械手把内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经超声传输元件(例如从换能器部分延伸到外科手术端部操纵装置的波导管)传递到外科手术端部操纵装置。波导管和端部操纵装置最优选地设计成以与换能器相同的频率共振。因此,当把端部操纵装置连接到换能器时,整个系统的频率将与换能器自身的频率相同。
纵向超声振动在端部操纵装置顶端d处的零至峰振幅表现为具有如下式给出的共振频率的简单正弦曲线:
d=A sin(ωt)
其中:
ω=角频率,它等于循环频率f的2π倍;并且
A=零至峰振幅。
纵向偏移被定义为峰至峰(p-t-p)振幅,它刚好是正弦波振幅的两倍或2A。
实心超声器械可分为两类:单元件端部操纵装置和多元件端部操纵装置。单元件端部操纵装置包括诸如刀片、手术刀、钩和/或球头凝固器的器械。多元件端部操纵装置可包括将组织压在超声刀片上的机构。多元件端部操纵装置包括夹紧手术刀和/或夹紧凝固器或夹紧组件与单元件端部操纵装置的任何组合。为了将超声能量有效传送到组织上而需要施加很大的压力时,可以使用多元件端部操纵装置。例如,可使用超声夹紧凝固器切割并凝固组织,尤其是疏松无支撑的组织。包括与夹具结合的超声刀片的多元件端部操纵装置可以向组织施加压缩力或偏置力,以加速凝固和切割组织。
超声夹紧凝固器提供了用于切割/凝固组织(尤其是疏松无支撑组织)的改进的超声手术器械,该器械将超声刀片与夹具结合,以向组织施加压缩力或偏置力,从而加速凝固和切割组织。
超声器械的设计和制造使得纵向超声振动的最大振幅(即波腹)位于或接近端部操纵装置的远端,以使远端纵向偏移最大。超声器械的有效长度通常被定义为从端部操纵装置远端(超声位移最大处)到沿着端部操纵装置的某个近端位置的距离,在该近端位置处,超声位移降到靠近波节(超声位移最小处)处的预定水平之下。端部操纵装置在波节周围(此处超声位移低于预定水平)的长度段被定义为波节间隙。因此,波节间隙是指其位移不足以产生高效和/或有效切割和/或凝固所需热量的波节附近的长度。
如本文所用,术语“波节间隙”是指其超声位移不足以产生高效和/或有效切割和/或凝固所需热量的端部操纵装置的长度段。如本文所用,术语“波节间隙区”是指波节附近的区域,并且可以指端部操纵装置上或端部操纵装置内的区域或与波节附近的端部操纵装置相邻的区域。如本文所用,术语“波节能隙”是指在波节附近产生的超声位移不足以生成高效和/或有效切割和/或凝固所需热量的状态。
波节附近的位移相对较小,这会导致向接触端部操纵装置的组织传送的热量在波节间隙区比在端部操纵装置的其他区域更低。因此,在波节间隙区,与刀片接触的组织不会直接受热。作为结果,该处的组织不能被有效切割和/或凝固,并可能在波节间隙区粘到端部操纵装置上,或者仅仅是被脱水而不能横切。希望提供在超声手术器械中用来有效消除波节间隙的端部操纵装置。
发明内容
在一个实施例中,与超声手术器械配合使用的端部操纵装置包括:具有第一声阻抗率值的第一部分和具有第二声阻抗率值的第二部分。第二声阻抗率值小于第一声阻抗率值。
附图说明
多个实施例的新型特征在所附权利要求书中详细示出。然而,通过参考结合以下附图给出的下列具体实施方式,无论是在手术的组织和方法方面,还是在手术的进一步的目标和优点方面,都可以最好地了解多个实施例。
图1示出了超声系统的一个实施例。
图2示出了用于超声器械的连接件/接头的一个实施例。
图3A示出了超声手术器械的一个实施例的分解透视图,该器械具有可连接到图1所示超声系统的单元件端部操纵装置。
图3B示出了具有多元件端部操纵装置的超声手术器械的一个实施例。
图3C示出了如图3B所示多元件端部操纵装置的一个实施例的详细透视图。
图3D示出了具有图3B和图3C所示多元件端部操纵装置的一个实施例的超声系统的一个实施例。
图4为多元件端部操纵装置的一个实施例的透视图。
图5为端部操纵装置的一个实施例中超声位移与长度/距离之间的函数关系图。
图6为端部操纵装置的一个实施例中校正超声位移与长度/距离之间的函数关系图。
图7-9示出了具有插入段的单元件端部操纵装置的多个实施例,其中插入段具有不同于端部操纵装置主体部分的声阻抗率值,其中:
图7为具有一个插入段的单元件端部操纵装置的一个实施例的侧视图;
图8为具有三个插入段的单元件端部操纵装置的一个实施例的侧视图;并且
图9为具有三个插入段的单元件端部操纵装置的一个实施例的侧视图。
图10-12为不锈钢端部操纵装置的多个实施例的校正超声位移与长度/距离之间的函数关系图,其中:
图10为纯不锈钢端部操纵装置的校正超声位移与长度/距离之间的函数关系图;
图11为具有铝插入段的不锈钢端部操纵装置的校正超声位移与长度/距离之间的函数关系图,其中铝插入段的横截面积与不锈钢部分的横截面积相配;并且
图12为具有铝插入段的不锈钢端部操纵装置的校正超声位移与长度/距离之间的函数关系图,其中铝插入段的横截面积为不锈钢部分横截面积的一半。
图13-18示出了超声手术器械的多个实施例,其中:
图13为不含插入段的常规构型的超声手术器械的一个实施例的局部侧视图;
图14为具有插入段的超声手术器械的一个实施例的局部侧视图,其中插入段设置在波节间隙区内的夹臂组件中;
图15为具有凸起的插入段的超声手术器械的一个实施例的局部侧视图,其中插入段设置在夹臂组件中;
图16为具有插入段的超声手术器械的一个实施例的局部侧视图,其中插入段设置在偏离波节的夹臂组件中;
图17为具有插入段的超声手术器械的一个实施例的局部侧视图,其中插入段设置在处于打开位置的夹臂组件中;并且
图18为具有插入段的超声手术器械的一个实施例的局部侧视图,其中插入段设置在处于关闭位置的夹臂组件中。
图19为具有夹臂组件和手术刀片的多元件端部操纵装置的一个实施例的局部侧视图。
图20为如图19所示的多元件端部操纵装置的一个实施例的透视图。
图21为具有夹臂组件和手术刀片的多元件端部操纵装置的一个实施例的局部侧视图。
图22-25示出了具有垫的超声手术器械的多个实施例,垫用于在与工作手术刀片接合时产生摩擦热,其中:
图22A为超声手术器械的一个实施例的局部侧视图,该超声手术器械处于打开位置和非工作状态,并具有朝向延伸元件远端而设置的垫;
图22B为图22A所示超声手术器械的一个实施例的端视图;
图23A为超声手术器械的一个实施例的局部侧视图,该超声手术器械处于关闭位置和工作状态,并具有朝向延伸元件远端而设置的垫;
图23B为图23A所示超声手术器械的一个实施例的端视图;
图24A为超声手术器械的一个实施例的局部侧视图,该超声手术器械处于打开位置和工作状态,并具有朝向延伸元件远端而设置的垫;
图24B为图24A所示超声手术器械的一个实施例的端视图;
图25A为超声手术器械的一个实施例的局部侧视图,该超声手术器械处于打开位置和非工作状态,并具有设置在延伸元件上且位于波节处的垫;
图25B为超声手术器械的一个实施例的局部侧视图,该超声手术器械处于打开位置和非工作状态,并具有设置在延伸元件上且从波节处向远端偏离的垫;
图25C为超声手术器械的一个实施例的局部侧视图,该超声手术器械处于打开位置和非工作状态,并具有设置在延伸元件上且从波节处向近端偏离的垫;
图25D为超声手术器械的一个实施例的局部侧视图,该超声手术器械处于打开位置和非工作状态,并具有设置在延伸元件上且横跨波节的不同长度的垫。
图26A-E示出了单元件端部操纵装置的多个实施例,其中:
图26A为具有内部腔体或孔的单元件端部操纵装置的横截面侧视图。
图26B为具有内部腔体或孔的单元件端部操纵装置的横截面侧视图。
图26C为具有内部腔体或孔的单元件端部操纵装置的横截面侧视图。
图26D为具有内部腔体或孔的单元件端部操纵装置的横截面端视图。
图26E为具有内部腔体或孔的单元件端部操纵装置的横截面端视图。
图27为超声端部操纵装置的一个实施例的局部侧视图,该超声端部操纵装置具有设置在刀片内的插入段、设置在夹臂组件的组织垫内的组织垫插入段和设置在延伸元件上的垫。
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,下文所公开的手术器械、端部操纵装置和刀片构型仅用于举例说明,并无意限制其范围或应用。此外,除非另外指明,本文所用的术语和表达是为了方便向读者描述示例性实施例的目的而选择的,并不是为了限制其范围。
多个实施例通常涉及在手术器械中使用的超声手术端部操纵装置,更具体地讲涉及在波节间隙区具有改进的升降、切割和凝固功能的超声手术端部操纵装置。多个实施例通常涉及用于实现改进的骨骼和组织移除、抽吸和凝固功能的超声手术端部操纵装置和器械。根据多个实施例的端部操纵装置特别是在以下手术中具有尤其有益的效果,在这些手术中,希望利用该装置的切割和凝固特点在移除骨骼和/或组织的同时控制出血,例如从骨骼上移除肌肉时。然而,端部操纵装置也可以用于常规的软组织切割和凝固。端部操纵装置可以是直的或弯曲的,并且可用于开放式或腹腔镜应用。根据多个实施例的端部操纵装置可用于脊柱手术,尤其是在从骨骼上移除肌肉时帮助从后路进入。根据多个实施例的端部操纵装置可以减小从骨骼上移除肌肉时需要使用者施加的力,并且在多个实施例中,可用于对组织进行同步的止血封口或烧灼。减小操作手术器械所需的力可以减缓使用者的疲劳、提高精度以及减少不必要的组织损伤。本发明公开了可用于开放式和腹腔镜应用的多种不同的端部操纵装置构型。
超声手术器械的例子在例如美国专利No.5,322,055和5,954,736中有所公开,结合超声刀片和手术器械的例子在例如美国专利No.6,309,400B2、6,278,218B1、6,283,981B1和6,325,811B1中有所公开,这些专利全文以引用方式并入本文中。这些参考文献公开了刀片被纵向激励的超声手术器械设计和刀片设计。现在将描述一些实施例来提供对本文公开的所述装置和方法的结构、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装置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。结合一个实施例示出或描述的特征可以与其他实施例的特征组合。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。
在一个一般方面中,多个实施例涉及和超声手术器械配合使用的端部操纵装置。该端部操纵装置包括具有第一声阻抗率值的第一部分和具有第二声阻抗率值的第二部分。第二声阻抗率值小于第一声阻抗率值。
在另一个一般方面中,多个实施例涉及和超声手术器械配合使用的端部操纵装置。该端部操纵装置包括:由第一声阻抗材料构成的远端段、由第二声阻抗材料构成的远端插入段、由第三声阻抗材料构成的中间插入段、由第四声阻抗材料构成的近端插入段以及由第五声阻抗材料构成的近端段。
在又一个一般方面中,多个实施例涉及和超声手术器械配合使用的端部操纵装置。该端部操纵装置包括近端段、远端段和插入段,其中插入段位于近端段和远端段之间。端部操纵装置的插入段包含有损耗材料或声阻抗率值不同于近端段和远端段的声阻抗率值的材料。
在又一个一般方面中,多个实施例涉及具有多个段的超声手术刀片。多个段中的至少一个被配置成填充和/或收窄波节能隙。在又一个一般方面中,多个实施例涉及包含单一材料的超声手术刀片。该刀片的声阻抗率沿长度变化。
在又一个一般方面中,多个实施例涉及具有换能器的手术器械,该换能器被配置成以预定频率沿纵向轴线产生振动。超声刀片沿纵向轴线延伸并连接到换能器。刀片包括具有近端和远端的主体。通过换能器产生的振动,远端可沿纵向轴线移动。具有近端和远端的不振动的夹臂组件可枢转地设置在主体附近。夹臂组件可从打开位置向关闭位置可枢转地移动。不振动的夹臂组件具有近侧组织垫段、远侧组织垫段和组织垫插入段,其中组织垫插入段设置在近侧组织垫段和远侧组织垫段之间。
在又一个一般方面中,多个实施例涉及具有换能器的手术器械,该换能器被配置成以预定的频率沿纵向轴线产生振动。超声刀片沿纵向轴线延伸并连接到换能器。刀片包括具有近端和远端的主体。通过换能器产生的振动,远端可沿纵向轴线移动。具有近端和远端的延伸元件设置在主体附近。延伸元件还包括垫,垫设置在延伸元件远端上并位于主体和延伸元件的远端之间。
在又一个一般方面中,多个实施例涉及具有换能器的手术器械,该换能器被配置成以预定的频率沿纵向轴线产生振动。超声刀片沿纵向轴线延伸并连接到换能器。刀片包括具有近端和远端的主体。通过换能器产生的振动,远端可沿纵向轴线移动。具有近端和远端的护套设置在主体附近。护套还包括垫,垫设置在护套远端上并位于主体和护套的远端之间。
图1示出了超声系统10的一个实施例。超声系统10的一个实施例包括连接到超声换能器14的超声信号发生器12,以及具有手把外壳16的手把组件60。超声换能器14的远端经适形于连接到超声传输组件,超声传输组件具有连接到单元件或多元件端部操纵装置的细长传输元件。被称为“Langevin叠堆”的超声换能器14通常包括换能部分18、第一共振器或端罩20、第二共振器或前罩22以及辅助元件。超声换能器14的长度优选地为系统波长一半的整数倍(nλ/2),下文将对此进行详细说明。声波组件24包括超声换能器14、鼻锥26、速度变换器28以及经适形于连接到超声传输组件的表面30。
应当理解,本文所用术语“近端”和“远端”是相对于持住手把组件60的临床医生而言的。因此,相对于处于更近端的手把组件60而言,端部操纵装置处于远端。还应当理解,为方便和清楚起见,本文所用诸如“顶部”和“底部”之类的空间术语也是相对于持住手把组件60的临床医生而言的。然而,手术器械可用于许多方向和位置,这些术语并不旨在起限制作用,也不是绝对的。
端罩20的远端连接到换能部分18的近端,而前罩22的近端则连接到换能部分18的远端。前罩22和端罩20具有由多个变量决定的长度,这些变量包括换能部分18的厚度、制造端罩20和前罩22所用材料的密度和弹性模量以及超声换能器14的共振频率。前罩22可以从其近端向其远端向内逐渐缩小,以作为速度变换器28放大超声振动的振幅,或者也可以不放大。合适的振动频率范围可以为约20Hz至120kHz,特别合适的振动频率范围可以为约30-100kHz,合适的工作振动频率可以为(例如)约55.5kHz。
压电元件32可由任何合适的材料制成,例如锆钛酸铅、偏铌酸铅、钛酸铅或其他压电陶瓷材料。正极34、负极36和压电元件32中的每一个均具有贯穿中心的孔。正极34和负极36分别电连接到电线38和40。电线38和40被包在电缆42内,并且可电连接到超声系统10的超声信号发生器12。
声波组件24的超声换能器14将来自超声信号发生器12的电信号转化为机械能,继而使超声换能器14和端部操纵装置以超声频率主要进行纵向振动。合适的发生器为得自Ethicon Endo-Surgery,Inc.,Cincinnati,Ohio的GEN04型发生器。当声波组件24通电时,会通过它产生振动运动驻波。沿声波组件24任意点处的振动运动的振幅可取决于沿声波组件24进行振动运动测量的位置。振动运动驻波的最小值或零交点通常称为波节(即运动最小的位置),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)。
电线38和40将来自超声信号发生器12的电信号传输至正极34和负极36。在触发机构(例如脚踏开关44)的作用下,压电元件32被超声信号发生器12提供的电信号激活,从而在声波组件24内产生声学驻波。电信号在压电元件32内产生反复的小位移形式的扰动,从而在材料内产生较大的压缩力。反复的小位移使压电元件32沿电压梯度的纵向轴线以连续方式伸展和收缩,从而产生超声能的纵波。超声能通过超声传输元件(如超声传输波导管)经声波组件24传输到端部操纵装置。
为了让声波组件24向端部操纵装置输送能量,声波组件24的所有元件都必须声学耦合到端部操纵装置上。超声换能器14的远端可以在表面30处通过螺纹连接(如螺柱48)声学耦合到超声传输波导管的近端。
声波组件24的元件优选地经过声学调整,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为声波组件24在预先选择的纵向振动驱动频率或工作纵向振动驱动频率fd下的波长,并且其中n为任意正整数。还可以设想的是,声波组件24可以结合任何合适的声波元件布置。
图2示出了用于声波组件24和超声传输元件(如超声传输波导管)之间的超声器械的连接件/接头70的一个实施例。连接件/接头70可以成形于超声传输波导管的连接柱54和声波组件24远端的速度变换器28的表面30之间。连接柱54近端具有大体上为圆柱形的内螺纹凹槽66,以将螺柱48的一部分接纳在其中。速度变换器28的远端也可以具有大体上为圆柱形的内螺纹凹槽68,以接纳螺柱48的一部分。凹槽66和68在圆周上和纵向上大体对齐。在另一个实施例中(未示出),螺柱是超声换能器末端的一体元件。例如,螺柱和速度变换器可以为一体构造,其中螺柱在声波组件的远端从速度变换器远极面伸出。在该实施例中,螺柱不是单独的元件,并且不需要在换能器末端具有凹槽。
图3A示出了超声手术器械100的一个实施例的分解透视图,该超声手术器械具有可连接到超声系统10的手把组件60(图1)的单元件端部操纵装置。超声手术器械100可以和上述超声系统10一起使用。然而,如本文所述,本领域的普通技术人员将会理解,在不脱离其范围的情况下,本文所公开的超声手术器械的多个实施例及其任何相当的结构可以设想能有效地结合其他已知的超声手术器械一起使用。因此,赋予本文所公开的多个超声手术端部操纵装置实施例的保护范围应不限于仅结合上述示例性超声手术器械一起使用。
在图3A所示的实施例中,细长的传输元件显示为超声波导管104,并且端部操纵装置显示为适合切割和/或凝固组织的单元件端部操纵装置或刀片50。刀片50可以为对称的或非对称的。
刀片50的长度可以基本上等于系统波长一半的整数倍(nλ/2)。刀片50的远端52可以设置在波腹附近,以使远端52的纵向偏移最大。当换能器组件被激活时,刀片50的远端52可以被配置成以预定的振动频率在(例如)约10至500微米峰至峰距离的范围内移动,并优选地在约30至150微米的范围内。
刀片50可以连接到超声传输波导管104。如图所示的刀片50和超声传输波导管104由适合传输超声能的材料(例如,Ti6Al4V(含有铝和钒的钛合金)、铝、不锈钢、其他已知材料或它们的组合)形成为一体构造。作为另外一种选择,刀片50可与超声传输波导管104分离(以及具有不同的组成),并通过(例如)螺柱、焊接、胶水、快速接头或其他合适的已知方法连接。超声传输波导管104的长度可以基本上等于(例如)系统波长一半的整数倍(nλ/2)。超声传输波导管104也可以优选地由实心轴制成,而实心轴由有效传播超声能的材料(例如,钛合金(如Ti6Al4V)或铝合金)构成。超声传输波导管104也可以由类似材料所构成的空心轴制成。超声传输波导管104也可以由组合式实心/空心轴制成,例如,具有设置在沿轴的长度上不同位置处的中空腔体的实心轴。
在图3A所示的实施例中,超声传输波导管104通过安装O形环108和密封环110设置在外护套106内。沿着超声传输波导管104也可以包括一个或多个附加的阻尼器或支承构件(未示出)。超声传输波导管104通过安装销112固定到外护套106上,其中安装销112穿过外护套106内的安装孔114和超声传输波导管104内的安装孔116。
超声传输波导管104具有在近端纵向伸出的连接柱54,以通过螺纹连接(例如螺柱48(图2))连接到超声传输波导管104的表面30。超声传输波导管104可以具有设置在多个节上的多个稳定硅氧烷环或适形的支承件(未示出)。硅氧烷环可以缓冲不可取的振动并防止超声能释放到外护套106之外,从而确保超声能在纵向上以最高效率朝刀片50的远端52传输。
外护套106通常包括毂和细长的管状构件。管状构件连接到毂上,并具有纵向穿过其中的开口。超声传输波导管104贯穿管状构件的开口,并连接到换能器14的远端。如前所述,外护套106通过穿过安装孔114的安装销112连接到超声传输波导管104上。外护套106可以连接到外壳16的远端,或者连接到连在外壳16上的转接件上,使得手术过程中施加过大的弯曲扭矩时,外护套106的后毂由外壳106来支撑。硅氧烷环可以将超声传输波导管104与外护套106隔离。
外护套的转接件优选地由塑料构成,管状构件由不锈钢制成。作为另外一种选择,超声传输波导管104外面可以用聚合材料包围,从而防止与外部接触。
超声传输波导管104的远端可优选地在波腹处或波腹附近通过内螺纹连接而连接到刀片50的近端。可以设想的是,刀片50可通过任何适当的方式(如焊接接头等)连接到超声传输波导管104。虽然刀片50可与超声传输波导管104拆开,但也可以设想到,刀片50和超声传输波导管104可以成形为一体式部件。
超声手术器械100可通过本领域已知的方法灭菌,例如,γ辐射灭菌、环氧乙烷灭菌、热压灭菌、杀菌液浸泡或其他已知的方法。在所示的实施例中,超声传输组件102包括超声端部操纵装置(通常称为超声刀片50)和超声传输波导管104。刀片50和超声传输波导管104显示为一体构造,其由适合传输超声能的材料(例如,Ti6Al4V、铝、不锈钢、其他已知材料以及它们的组合)制成。作为另外一种选择,超声刀片50可与超声传输波导管104分开(以及具有不同的组成),并通过(例如)螺柱、焊接、胶水、快速接头或其他已知方法连接。超声传输波导管104可具有(例如)基本上等于二分之一系统波长的整数倍(nλ/2)的长度。
图3B示出了具有如图3A所示多元件端部操纵装置的超声手术器械1002的一个实施例。图3C示出了如图3B所示多元件端部操纵装置的一个实施例的透视图。结合图3B、图3C和图3D,夹紧的凝固剪1002可以优选地连接到声波组件18上,并可作为一个单元从上面移除。夹紧的凝固剪1002的近端优选地声学耦合到声波组件18的远极面30。夹紧的凝固剪1002可通过任何适当的方式连接到声波组件18。
夹紧的凝固剪1002优选地包括器械外壳1004和细长构件1006。细长构件1006可以相对于器械外壳1004选择性地旋转。器械外壳1004包括枢转柄部1028和固定柄部1029。
分度机构(未示出)设置在器械外壳1004的腔体内。分度机构优选地耦合或连接到内管1014上,以将枢转柄部1028的运动转变为内管1014的线性运动,从而打开和关闭多元件端部组件1008。当枢转柄部1028向固定柄部1029移动时,分度机构向后滑动内管1014,以将多元件端部组件1008枢转至关闭位置。枢转柄部1028以相反的方向运动时将滑动分度机构,使内管1014以相反方向(即向前)移动,从而将多元件端部组件1008以图3B所示箭头1020方向枢转至打开位置。
枢转柄部1028包括指环1030。枢轴销1032设置成穿过枢转柄部1028的第一孔洞,以允许按照图3B的箭头1034所示方向枢转。当枢转柄部1028的指环1030朝箭头1034方向移动并远离器械外壳1004时,内管1014向后滑动,以将多元件端部组件1008枢转至关闭位置。
夹紧凝固剪1002的细长构件1006伸出器械外壳1004。细长构件1006优选地包括外部构件或外管1012、内部构件或内管1014以及传输元件或超声传输波导管104。
多元件端部操纵装置或多元件端部组件1008包括夹臂1018、组织垫1036和超声刀片1016。夹臂1018绕枢轴销(未示出)可枢转地安装,以朝箭头1038所示方向旋转。超声刀片1016包括向内伸入刀片主体的渐缩凹面1040。
图3D示出了超声系统1000的一个实施例,该超声系统具有多元件端部操纵装置的一个实施例。结合图1所述,超声系统1000的一个实施例包括连接到超声换能器14的超声发生器12。超声换能器14连接到具有器械外壳1004的夹紧凝固剪1002。声波组件18将能量输送到多元件端部组件1008。为了让声波组件18将能量输送到多元件端部组件1008,声波组件18的所有元件都必须声学耦合到夹紧凝固剪1002的超声工作部分。因此,超声换能器14的远端可以在表面30处通过螺柱48声学耦合到超声传输波导管104的近端。
如上文结合超声系统10(图1)所述,声波组件18的元件优选地经过声学调整,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为声波组件18在预先选择的纵向振动驱动频率或工作纵向振动驱动频率fd下的波长,并且其中n为任意正整数。声波组件18可以具有声波元件的任何合适布置。
超声手术器械100和夹紧凝固剪1002可以通过本领域已知的方法进行灭菌,例如,γ辐射灭菌、环氧乙烷灭菌、热压灭菌、杀菌液浸泡或其他已知的方法。在图1和图2所示的实施例中,手术器械100的超声传输组件102包括连接到超声传输波导管104的单元件超声致动端部操纵装置或刀片50。刀片50和超声传输波导管104显示为由前述适合传输超声能的材料(例如,Ti6Al4V、铝、不锈钢或其他已知材料)制成的一体构造。作为另外一种选择,刀片50可与超声传输波导管104分离(以及具有不同的组成),并通过(例如)螺柱、焊接、胶水、快速接头或其他已知方法连接。
在图3B和图3D所示的实施例中,夹紧凝固剪1002的超声传输组件1024包括连接到超声传输波导管104的多元件端部组件1008。超声传输波导管104的长度可以(例如)基本上等于二分之一系统波长的整数倍(nλ/2)。超声传输波导管104可以优选地由实心轴制成,而实心轴由有效传播超声能的材料(例如,钛合金(如Ti6Al4V)或铝合金)构成。
图4为具有夹臂组件1108和超声刀片1116的多元件端部操纵装置1111的一个实施例的透视图。夹臂组件1108包括夹臂1118和组织垫1136。端部操纵装置1111设置在外管1112的远端。
超声器械的有效长度为端部操纵装置在使用过程中可以实现所需组织效果(如切割和凝固)的位置距远端之间的长度。超声器械的有效长度可以定义为:从端部操纵装置的远端(超声位移最大处)到近端方向超声位移减至低于预定水平处的长度/距离。在有效长度之外,端部操纵装置可能无法向接触端部操纵装置的组织提供足够的热量来实现(例如)高效和/或有效的切割和/或凝固。
在某些情况下,有效长度被定义为从端部操纵装置的远端到超声位移减小至最大位移的50%的近端位置之间的长度。50%的标准是考虑到实现可接受的切割和/或凝固通常所需的超声能。然而,也可以用其他百分比的超声位移减少来量化有效长度(和波节间隙)。本领域的普通技术人员可以根据所涉及的具体超声系统来量化有效长度(和波节间隙)。
图5为端部操纵装置的一个实施例中,对纵向超声振动的半波长(λ/2)而言,超声位移152与长度/距离154之间的函数关系图150。有效长度156为从端部操纵装置的远端158(出现最大位移160的位置)到位移减小至最大位移160的50%的点164之间的长度。一般来说,有效长度156为四分之一波长(λ/4)的一部分。端部操纵装置的长度可以基本上等于二分之一系统波长的整数倍(nλ/2),其中“n”为任意正整数。因此,有效长度156是端部操纵装置总长度(未示出)甚至更小的一部分。波节间隙166对应于端部操纵装置以波节162为中心并在点164和点163之间延伸的长度段。在波节间隙区(沿端部操纵装置长度方向与波节间隙166相邻)内,向组织提供的超声能可能不足以实现可接受的切割和/或凝固。如果可以跨越、填充或以其他方式消除波节间隙166,则可以显著增加有效长度156。
图6为端部操纵装置的一个实施例中,对于纵向超声振动的全波长(λ)而言,校正超声位移182与长度/距离184之间的函数关系图180。如果可以跨越、填充或以其他方式消除波节间隙196,则可以将有效长度显著增加至潜在有效长度186。如果波节间隙196被跨越、填充或以其他方式消除,那么潜在有效长度186即从端部操纵装置远端的最大超声位移点190出发,经过第一波节192A及对应的波节间隙196,延伸至点194,点194处的超声位移减小至最大值的50%,并接近远端和第一波节192A近侧的第二波节192B。
多个实施例通常涉及用来跨越、填充或以其他方式消除波节间隙的方法。更具体地讲,多个实施例涉及与超声手术器械配合使用的端部操纵装置,该操纵装置体现了用来跨越、填充或以其他方式消除波节间隙的方法。第一方法是通过改变端部操纵装置的组成来收窄或闭合波节间隙。该方法可以有效跨越波节间隙。第二方法是通过向波节间隙区内的组织输送热量来填充波节间隙。
按照定义,波节处的超声位移为零。如图6所示,在波节附近,位移以大致线性的方式增加。如果校正位移相对于距离的曲线(位移-距离曲线)的斜率在波节附近增大,则波节间隙将减小。在极限情况下,当斜率逼近无限大(即垂直)时,波节间隙将变为零。为了增加波节附近的位移,从而减小波节间隙,可以沿端部操纵装置的纵向轴线在端部操纵装置内插入一段材料,该材料的声阻抗率值比构成端部操纵装置主体部分的材料的声阻抗率值更小。位移-距离曲线在波节附近的斜率的相对陡度可通过端部操纵装置主体部分与波节处或波节附近的区段的声阻抗率比值来确定。
特性声阻抗是指,在介质的自由前进波中,某点的有效声压与该点处的质点速度的比率。特性声阻抗等于介质的密度与声音在介质内的传播速度的乘积,它是材料的固有属性。系统的声阻抗率是构成该系统的材料的特性声阻抗与波所穿过的系统横截面积的乘积。因此,波节附近的位移可以通过材料属性的差异、横截面积的差异或二者的组合来增加,进而增大位移-距离曲线在波节附近的斜率。
图7-9示出了端部操纵装置的多个实施例,这些端部操纵装置包括具有与端部操纵装置主体部分不同的声阻抗率值的插入段。图7为具有一个插入段212的单元件端部操纵装置200的一个实施例的侧视图。端部操纵装置200具有近端204和远端206,并沿纵向轴线201延伸。插入段212沿端部操纵装置200的纵向轴线201位于近端段208和远端段210之间。在一个实施例中,插入段212可以位于波节202处或其附近,并设置在波节间隙213内。在另一个实施例中,插入段212可以位于波节间隙213内,但偏离波节202(未示出)。在另一个实施例中,插入段212沿纵向轴线201的长度可以等于波节间隙213的长度。在又一个实施例中,插入段212可以偏离波节202,并且完全或部分地位于波节间隙213之外。
在多个实施例中,近端段208和远端段210构成具有第一声阻抗率值的端部操纵装置200的第一部分或主体部分。插入段212构成具有不同于第一声阻抗率值的第二声阻抗率值的第二部分。插入段212可以在端部操纵装置200上具有涂层,涂层材料具有第二声阻抗率值。第一声阻抗率值和第二声阻抗率值的差值可以是第一部分与第二部分材料属性不同的结果,或者是第一部分和第二部分横截面积不同的结果,或者两种情况都有。在多个实施例中,由于第二部分包含具有相对较小的特性声阻抗值的材料,而第一部分包含具有相对较大的特性声阻抗值的材料,因此第二声阻抗率值小于第一声阻抗率值。在多个实施例中,由于第二部分具有比第一部分更小的横截面积,因此第二声阻抗率值小于第一声阻抗率值。在多个实施例中,横截面积减小是由于端部操纵装置200内具有内部孔洞或腔体(参见图26A-C)。
远端段210、近端段208和插入段212可以具有相配的横截面积。远端段210和近端段208可包含第一材料,而插入段212则可包含具有比第一材料更低的特性声阻抗值的第二材料。作为另外一种选择,远端段210、近端段208和插入段212都可以包含相同的材料,但插入段212可具有比远端段210和近端段208更小的横截面积。然而,插入段212的横截面积只能减小到能够安全承受内部超声应力(波节202处最大)的程度。横截面积减小会导致声阻抗率减小,进而导致波节间隙213内的超声位移增加,从而收窄波节间隙213。在多个实施例中,插入段212横截面积减小是由于在端部操纵装置200内形成了内部孔洞或腔体(参见图26A-C)。
在多个实施例中,插入段212由声音有损耗材料构成。如本文所用,有损耗材料是指会损耗穿过该材料的声能并转化为热能的材料。一般来说,由于希望以最小的能量损耗将超声振动能有效传输到端部操纵装置,因此端部操纵装置和超声器械的其他元件并不由有损耗材料制成。在与组织相互作用时,端部操纵装置的超声位移将超声振动能转化为热能。然而,由于在波节间隙内超声位移最小,端部操纵装置可能无法将超声振动能高效或有效地转化为热能。因此,当在端部操纵装置内于波节间隙处或附近插入有损耗材料时,由于有损耗材料产生的内部能量损耗,可以在波节间隙内将超声能转化为热能。具体地讲,有损耗材料可以将材料中的内部超声应力(波节处最大)消耗并转化为热能。有损耗段产生的热损耗被导向组织,从而有效填充波节间隙区的波节能隙。
在多个实施例中,插入段212包含有损耗材料,因而当具有端部操纵装置200的超声器械在空气或其他介质中工作并且不接触组织时,可以持续地产生热量。持续产生的热量可以升高端部操纵装置200波节间隙213内的局部温度。通过向端部操纵装置200的相邻区域进行热传递可以减小温升。因此,为了减小温升,在多个实施例中,插入段212可以由横截面积比远端段210和近端段208的横截面积更小的有损耗材料制成。减少波节间隙213内的材料量(即,减小端部操纵装置200的横截面积)可以减小声阻抗率值,从而收窄并同时填充波节间隙213。在多个实施例中,插入段212包含有损耗材料并具有减小的横截面积。在多个实施例中,插入段212的横截面积减小是由于在端部操纵装置200内形成了内部孔洞或腔体(参见图26A-C)。在多个实施例中,插入段212包含位于端部操纵装置200的一个部分或区域内的有损耗材料涂层。在多个实施例中,插入段212包含位于端部操纵装置200的一个部分或区域内的高摩擦材料涂层。高摩擦材料具有比构成端部操纵装置200的主体部分的材料更大的摩擦系数。
波节间隙213收窄的程度直接取决于插入段212的声阻抗率值与远端段210和近端段208的声阻抗率值的相对值。位移-距离曲线在波节202附近的斜率的相对陡度可由远端段210的声阻抗率值与插入段212的声阻抗率值的比率确定。为了通过采用具有不同特性声阻抗值的材料来显著收窄波节间隙213,可能要求材料具有明显不同的特性声阻抗值。这可能需要端部操纵装置主要由具有相对较高的特性声阻抗值的材料制成。
图8为具有插入段232、234和236的单元件端部操纵装置220的一个实施例的侧视图。在多个实施例中,插入段232、234和236可以在波节222处或附近位于近端段228和远端段230之间。近端段228和远端段230共同构成端部操纵装置220的主体部分。插入段232由具有比形成端部操纵装置220主体部分的材料更高的特性声阻抗值的材料制成,并位于两个附加的插入段234和236之间,这两个附加的插入段由具有比形成端部操纵装置220主体部分的材料更低的特性声阻抗值的材料制成。形成插入段232的材料具有自加热属性,这主要是由于其较高的特性声阻抗值。因此,将具有自加热属性的插入段232设置在位于波节222处或附近的中间位置,可以有效地最大限度减小或基本上消除波节间隙。在这种情况下,具有最大特性声阻抗值的中间插入段232起着类似于上述声音有损耗插入段的作用。
端部操纵装置220具有近端224和远端226,并沿纵向轴线221延伸。中间插入段232沿纵向轴线221位于近端插入段234和远端插入段236之间。近端插入段234、中间插入段232和远端插入段236沿纵向轴线221位于近端段228和远端段230之间。远端段230包含第一声阻抗材料,远端插入段236包含第二声阻抗材料,中间插入段232包含第三声阻抗材料,近端插入段234包含第四声阻抗材料,近端段228包含第五声阻抗材料。
在一个实施例中,第二声阻抗材料(远端插入段236)和第四声阻抗材料(近端插入段234)相同。在一个实施例中,第一声阻抗材料(远端段230)和第五声阻抗材料(近端段228)相同。在一个实施例中,第一声阻抗材料(远端段230)、第三声阻抗材料(中间插入段232)和第五声阻抗材料(近端段228)相同。在一个实施例中,第一声阻抗材料、第三声阻抗材料和第五声阻抗材料均具有比第二声阻抗材料和第四声阻抗材料更大的特性声阻抗值。在一个实施例中,所有五种声阻抗材料均具有不同的声阻抗率值。
在一个实施例中,中间插入段232可位于波节222处或其附近,并设置在波节间隙内。在另一个实施例中,中间插入段232可位于波节间隙内,但偏离波节222(未示出)。在又一个实施例中,插入段232沿纵向轴线221的长度可以等于波节间隙(未示出)的长度。在又一个实施例中,中间插入段232可以偏离波节222,并完全或部分地位于波节间隙(未示出)之外。在又一个实施例中,近端插入段234、中间插入段232和远端插入段236可以位于波节间隙内。在又一个实施例中,近端插入段234、中间插入段232和远端插入段236可以部分或完全地位于波节间隙之外。
图9为具有插入段252、254和256的单元件端部操纵装置240的一个实施例的侧视图。端部操纵装置240具有近端244和远端246,并沿纵向轴线241延伸。中间插入段252沿纵向轴线241位于近端插入段254和远端插入段256之间。近端插入段254、中间插入段252和远端插入段256沿纵向轴线241位于近端段248和远端段250之间。远端段250包含第一声阻抗材料,远端插入段256包含第二声阻抗材料,中间插入段252包含第三声阻抗材料,近端插入段254包含第四声阻抗材料,近端段248包含第五声阻抗材料。
在多个实施例中,第三声阻抗材料(中间插入段252)可具有比第一声阻抗材料(远端段250)和第五声阻抗材料(近端段248)更大的声阻抗值。第二声阻抗材料(远端插入段256)和第四声阻抗材料(近端插入段254)可具有比第一声阻抗材料和第五声阻抗材料更小的声阻抗值。
在一个实施例中,中间插入段252可以位于波节242处或其附近,并设置在波节间隙内。在另一个实施例中,中间插入段252可以位于波节间隙内,但偏离波节242(未示出)。在又一个实施例中,插入段252沿纵向轴线241的长度可以等于波节间隙(未示出)的长度。在又一个实施例中,中间插入段252可以偏离波节242,并且完全或部分地位于波节间隙(未示出)之外。在又一个实施例中,近端插入段254、中间插入段252和远端插入段256可以位于波节间隙内。在又一个实施例中,近端插入段254、中间插入段252和远端插入段256可以部分或完全地位于波节间隙之外。
结合图7-9所述的插入段已经从“段”的角度进行了一般性描述,这些“段”包含具有不同声阻抗值的材料和声音有损耗材料。然而,上述插入段也涵盖单元件端部操纵装置的区域,这些区域具有声阻抗值不同的材料的涂层、声音有损耗材料的涂层和高摩擦材料的涂层。此外,具有不同声阻抗值的插入段可通过冷处理具有(例如)单一材料的单元件端部操纵装置的不同区域来形成。本发明并不限于此背景。
外科手术器械中的三种常用金属的特性声阻抗显著不同。
不锈钢(SS):40*106rayl
钛(TI):    22*106rayl
铝(AL):    14*106rayl
表1给出了基于简单端部操纵装置设计的数学模型的结果,该设计采用了用于跨越和/或填充波节间隙的上列材料和多种构型。端部操纵装置包括具有近端段和远端段的主体部分或第一部分,还包括具有插入段的第二部分。可对插入段的长度和位置进行选择,以使得插入段位于波节处,并且位移-距离曲线的斜率在如图10-12所示预定位移值处相交。长度以英寸(mm)为单位,插入段的横截面积记录为端部操纵装置主体部分横截面积的百分比。
表1。跨越/填充式端部操纵装置的波节间隙和有效长度
  材料配置   插入段面积   波节间隙   标准有效长度   潜在有效长度
  SS   ----   0.601(15.3)   0.600(15.2)   2.401(61.0)
  SS-AL-SS   100%   0.221(5.61)   0.597(15.2)   2.020(51.3)
  SS-AL-SS   50%   0.134(3.40)   0.600(15.2)   1.934(49.1)
  TI   ----   0.579(14.7)   0.578(14.7)   2.313(58.8)
  材料配置   插入段面积   波节间隙   标准有效长度   潜在有效长度
  TI-AL-TI   100%   0.411(10.4)   0.579(14.7)   1.934(49.1)
  TI-AL-TI   50%   0.209(5.31)   0.576(14.6)   1.939(49.3)
  TI-TI-TI   50%   0.319(8.10)   0.583(14.8)   2.074(52.7)
  AL   ----   0.592(15.0)   0.591(15.0)   2.365(60.1)
  AL-AL-AL   50%   0.329(8.28)   0.588(14.9)   2.086(53.0)
波节间隙减小最多的是具有铝插入段的不锈钢端部操纵装置。在50%超声位移振幅点之间测量,无插入段的不锈钢端部操纵装置具有0.601英寸的波节间隙。在50%超声位移振幅点之间测量,具有横截面积与不锈钢部分相等的铝插入段的不锈钢端部操纵装置具有收窄至0.221英寸的波节间隙。在50%超声位移振幅点之间测量,具有横截面积为不锈钢部分一半的铝插入段的不锈钢端部操纵装置具有收窄至0.134英寸的波节间隙。此时波节间隙长度减小了78%。
图10-12为与上述类似的不锈钢端部操纵装置的多个实施例的校正超声位移与长度/距离之间的函数关系图(位移-距离曲线)。图10为完全由不锈钢形成的端部操纵装置的校正超声位移302与长度/距离304之间的函数关系图300。标准有效长度318从端部操纵装置远端308(位移在点310处最大)到波节312A远端的50%超声位移点311进行测量。波节间隙316在波节312A两侧的50%超声位移点311和313之间延伸。潜在有效长度306从远端308延伸到波节312B远端的50%超声位移点314。
图11为不锈钢端部操纵装置的校正超声位移322与长度/距离324之间的函数关系图320,其中不锈钢端部操纵装置包括具有与不锈钢部分相等的横截面积的铝插入段。标准有效长度338从端部操纵装置远端328到波节332A远端的50%超声位移点331进行测量。波节间隙336在波节332A两侧的50%超声位移点331和333之间延伸。潜在有效长度326从远端328延伸到波节332B远端的50%超声位移点334。通过比较图10中的波节间隙316和图11中的波节间隙336可以发现,在不锈钢端部操纵装置上添加铝插入段可以显著收窄波节间隙。
图12为不锈钢端部操纵装置的校正超声位移342与长度/距离344之间的函数关系图340,其中不锈钢端部操纵装置具有横截面积为不锈钢部分一半的铝插入段。标准有效长度358从端部操纵装置远端348到波节352A远端的50%超声位移点351进行测量。波节间隙356在波节352A两侧的50%超声位移点351和353之间延伸。潜在有效长度346从远端348延伸到波节352B远端的50%超声位移点354。通过比较图10中的波节间隙316、图11中的波节间隙336和图12中的波节间隙356可以发现,在不锈钢端部操纵装置上添加铝插入段(其中铝插入段的横截面积为端部操纵装置不锈钢主体部分横截面积的一半)可以进一步显著收窄波节间隙。
本领域的普通技术人员将认识到,端部操纵装置的具体构型(即构造的尺寸、形状和确切材料)部分取决于要将端部操纵装置用于其中的超声器械的具体特性。然而,本文所述的端部操纵装置可以包括但不限于超声手术刀片设计(诸如结合图1-4所述的那些)或适合在超声器械中使用的任何其他已知的外科手术工具。
本文所述的端部操纵装置可以使用任何已知的加工方法或其他合适的制造方法制造。例如,表1中的TI-TI-TI或AL-AL-AL端部操纵装置可以使用标准车床技术和/或放电加工(EDM)技术容易地制造。本领域的普通技术人员将会知道关于所用的具体加工技术的细节,例如,在EDM过程中形成再铸层时通常需要抛光,以免金属脆化。此外,包含材料与主体部分材料相异的插入段的端部操纵装置(如表1中的SS-AL-SS和TI-AL-TI构造)可通过任何合适的方法(例如激光焊接)制造。
本领域的技术人员还将认识到,面积减小段的形状和构型一定程度上将取决于所用端部操纵装置和超声系统的具体特性。还应认识到的是,本文使用了术语“插入段”来描述(但不限于)端部操纵装置中横截面积比主体部分横截面积小的一部分。例如,“插入段”可以指端部操纵装置具有内部腔体或孔的区域。本文还使用术语“插入段”来描述端部操纵装置具有涂层的区域或部分。术语“插入段”旨在以一般方式描述端部操纵装置的这些区域或部分,并不限制该区域或部分的制造方法。
多个实施例已经描述了通过控制端部操纵装置的材料和/或几何形状来跨越、填充或以其他方式消除波节间隙(如缩小波节间隙长度或通过热量填充波节能隙)。附加的实施例涉及用与端部操纵装置相互作用的结构产生的热量填充波节能隙。在这些实施例中,端部操纵装置可以是超声手术刀片,其能传导因与插入段(位于夹臂上)和/或垫(位于超声器械的附加元件上)之间的摩擦作用而产生的热。插入段和/或垫的布置方式使得摩擦产生的热量被传导至超声刀片的波节间隙区内,从而有效填充波节能隙。
图13-18示出了超声手术器械的多个实施例。图13为超声手术器械400的一个实施例的局部侧视图,该超声手术器械采用不带组织垫插入段的常规构型。超声手术器械400包括外管418。超声手术刀片402沿纵向轴线422延伸并连接到换能器,并包括具有近端406和远端408的主体404。远端408可以通过换能器产生的振动相对于纵向轴线422移动。超声手术器械400还包括具有近端412和远端414的不振动夹臂组件410。夹臂组件410进一步包括组织垫416。超声手术刀片402的布置方式使得等于超声振动波波长约四分之一(λ/4)的长度被露出,该长度等于刀片402的有效长度。夹臂410在节点420处或附近枢转。夹臂410可以从打开位置可枢转地移动到关闭位置。
图14为超声手术器械450的一个实施例的局部侧视图,该超声手术器械具有设置在夹臂组件460的组织垫内的插入段468。超声手术器械450包括外管472。超声手术器械450连接到换能器14(图1),换能器被配置成以预定的频率沿纵向轴线476产生振动。超声刀片452沿纵向轴线476延伸并连接到换能器14,并包括具有近端456和远端458的主体454。远端458可以通过换能器产生的振动相对于纵向轴线476移动。超声手术器械450还包括具有近端462和远端464的不振动夹臂组件460。夹臂组件460进一步包括近侧组织垫段466、远侧组织垫段470和设置在近侧组织垫段466与远侧组织垫段470之间的组织垫插入段468。夹臂组件460可以从图13-17所示的打开位置可枢转地移动到图18所示的关闭位置。夹臂组件460沿弧480(图17-18)枢转,使得当处于关闭位置时,插入段468可位于对应于波节474的位置。
图15为超声手术器械450的一个实施例的局部侧视图,该超声手术器械具有设置在夹臂组件460的组织垫内的凸起插入段468。凸起的组织垫插入段468使得当夹臂组件460处于如图18所示的关闭位置时,摩擦作用增强。摩擦作用的增强导致当夹臂组件460处于关闭位置时产热增加。
图16为超声手术器械450的一个实施例的局部侧视图,该超声手术器械具有设置在夹臂组件460的组织垫内的插入段468。组织垫插入段468设置在组织垫内,使得当夹臂组件460处于关闭位置(图18)时,插入段偏离波节474一段预定距离。
图14-18所示超声手术刀片452的多个实施例可具有外露长度,该长度从约超声振动波波长的四分之一(λ/4)至约超声振动波的整个波长(λ)。在多个实施例中,超声手术刀片452的长度为约超声振动波波长的四分之三(3λ/4)。例如,在频率为55.5kHz下工作的弯曲钛刀片的长度为约超声振动波波长的四分之三(3λ/4)或约49mm。本领域的普通技术人员将认识到,波节474的位置(及相应的波节间隙)将决定构成超声手术器械450的多个元件的定位和位置。
本领域的普通技术人员将认识到,组织垫插入段468可以在夹臂组件460的组织垫内具有合适的尺寸和位置,以达到所需的摩擦生热效果。例如,在多个实施例中,组织垫插入段468可以高于组织垫(包括近侧组织垫段466和远侧组织垫段470)的标称高度,并当夹臂组件460处于关闭位置时,可以偏离波节474。在多个实施例中,组织垫插入段468可与组织垫的顶部表面齐平,并以波节474为中心。在其他实施例中,组织垫插入段468可以高于组织垫的标称高度,并以波节474为中心。在其他实施例中,组织垫插入段468可与组织垫的顶部表面齐平,并可以偏离波节474。组织垫插入段468可以具有合适的尺寸(即长度、宽度和厚度),以达到所需的摩擦生热效果。组织垫插入段468的定位和尺寸的灵活性允许为给定应用设计沿刀片452摩擦产生的额外热量的分布图。
组织垫插入段468可以由任何合适的材料制成,该材料在压到超声手术刀片452上时可以摩擦生热。用于组织垫插入段468的示例性材料包括具有高熔融温度和高有效摩擦系数的聚合材料。聚酰亚胺便是这样一种示例性材料。此外,组织垫插入段468可以为组织垫的凸起区域,其中插入段468、近侧组织垫段466和远侧组织垫段470全部采用相同的材料,并以一体式构造制造成一个连续元件。
图19为具有夹臂组件602和手术刀片604的多元件端部操纵装置600的一个实施例的局部侧视图。图示夹臂组件602处于打开位置,并且包括夹臂603、近侧组织垫段606、组织垫插入段608和远侧组织垫段610。插入段608可以设置在夹臂603上的近侧组织垫段606和远侧组织垫段610之间的某一位置处,当夹臂组件602处于关闭位置时,插入段的位置对应于刀片604的波节间隙区614。在一个实施例中,插入段608可以位于波节612处或其附近,并当夹臂组件602处于关闭位置时,插入段设置在波节间隙614内。在另一个实施例中,插入段608可以位于波节间隙614内,但偏离波节612(未示出)。在又一个实施例中,插入段608沿夹臂603的长度可以等于波节间隙614(未示出)的长度。在又一个实施例中,插入段608可以偏离波节612,并且完全或部分地处于波节间隙614(未示出)之外。图20为图19的多元件端部操纵装置600的一个实施例的透视图。
图21为具有夹臂组件652和手术刀片654的多元件端部操纵装置650的一个实施例的局部侧视图。图示夹臂组件652处于打开位置,并且具有夹臂653、近侧组织垫段656、组织垫插入段658和远侧组织垫段660。夹臂组件652还包括偏压装置665。偏压装置665包括提供附加力的机构,附加力以比周围的组织垫更大的力将插入段658压到刀片654上,即,当夹臂组件652处于关闭位置时,偏压装置665会以比近侧组织垫段656和远侧组织垫段660向刀片654施加的力更大的力将插入段658压到刀片654上。偏压装置665可以包括片簧或能够通过插入段658向刀片654提供更大的力的其他机构。
插入段658可以设置在夹臂653上的近侧组织垫段656和远侧组织垫段660之间的某一位置处,当夹臂组件652处于关闭位置时,插入段的位置对应于刀片654的波节间隙区。在一个实施例中,插入段658可以位于波节662处或其附近,并当夹臂组件652处于关闭位置时,插入段设置在波节间隙内。在另一个实施例中,插入段658可以位于波节间隙内,但偏离波节662(未示出)。在又一个实施例中,插入段658沿夹臂653的长度可以等于波节间隙(未示出)的长度。在又一个实施例中,插入段658可以偏离波节662,并且完全或部分地处于波节间隙(未示出)之外。
图13-21示出了具有刀片和夹臂组件的多个实施例,其中夹臂组件具有近侧组织垫段、远侧组织垫段和组织垫插入段。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轴点而受到影响,其中夹臂组件通过焊接销轴紧固件或其他紧固装置(未示出)与超声手术器械接合。组织垫段可以通过机械方式连接到夹臂上,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连接到夹臂上。
在多个实施例中,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。在多个实施例中,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一个或多个步骤:a)使夹臂组件脱离超声手术器械;b)从夹臂上移除至少一个组织垫段;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一个或多个步骤:a)打开夹臂上的凸缘;b)从夹臂上移除至少一个组织垫段;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。
图22-25示出了具有垫的超声手术器械的多个实施例,当与工作中的超声手术刀片接合时,垫用来摩擦生热。图22A为超声手术器械500的一个实施例的局部侧视图,该超声手术器械处于打开位置和非工作状态,并具有朝向延伸元件520的远端528设置的垫522。图22B为图22A的超声手术器械的一个实施例的端视图。垫522邻近刀片主体504,其设置在延伸元件520上并朝向远端528,同时位于刀片主体504和延伸元件520的远端528之间。超声手术器械500具有外管518。超声手术刀片502沿纵向轴线524延伸并连接到换能器14(图1),并包括具有近端506和远端508的主体504。远端508可通过换能器14产生的振动沿纵向轴线524移动。超声手术器械500还包括具有近端512和远端514的不振动夹臂组件510。夹臂组件510还包括组织垫516。
超声手术刀片502的布置方式使得等于约超声振动波波长四分之三(3λ/4)的长度被露出。夹臂组件510可从打开位置可枢转地移动到关闭位置。夹臂组件510可以沿着弧线枢转,其方式类似于结合图17和图18讨论的夹臂460的枢转方式。在多个实施例中,延伸元件520可以为外管518的延伸(即外管构件)。延伸元件520可以类似于垂直纵向轴线524的外管518的弯曲方式弯曲(图22B、23B和24B)。延伸元件520的弯曲可以比平面构造赋予延伸元件520大得多的弯曲硬挺度。延伸元件520的弯曲硬挺度增加是有利的,因为当刀片502与垫522接合时,这可以抗延伸元件520发生挠曲。
在其他实施例中,延伸元件520可以为独立于外管518的元件。例如,延伸元件520可以为具有近端526和远端528的护套并设置在刀片主体504附近。垫522可以设置在护套520上并朝向远端528,同时位于主体504和护套520的远端528之间。在多个实施例中,护套520可以固定连接到超声手术器械500上。在其他实施例中,护套520可以可滑动地与超声手术器械500接合。在多个实施例中,通过将护套520沿纵向轴线524向刀片502的远端508推进,可灵活定位护套520。护套520可以沿纵向轴线524向近端收回。
图23A为处于关闭位置和工作状态的超声手术器械500的一个实施例的局部侧视图,其中垫522在界面530处与刀片主体504接合。图23B为图23A的超声手术器械的一个实施例的端视图。处于关闭位置时,夹臂510在底部表面528上与刀片502的主体504接合。夹臂组件510提供的偏置力使刀片502向延伸元件520偏转。刀片502发生偏转并在刀片主体504的顶部表面526接触垫522。垫522和刀片主体504在界面530处接合。垫522与激活的刀片主体504在界面530上的摩擦作用产生热,其传导至刀片502。传导的热可以在刀片502与垫522接合的区域内产生切割和/或凝固温度。如果垫522的布置方式使得界面530位于波节(未示出)处或其附近,则摩擦产生的热将填充波节能隙,从而将刀片502的有效长度从约四分之一振动波波长(λ/4)有效延长至约四分之三振动波波长(3λ/4)(例如,对于在55.5kHz下工作的弯曲钛刀片来说,为约49mm)。
图24A为处于打开位置和工作状态的超声手术器械500的一个实施例的局部侧视图,其中垫522未与刀片主体504接合,并且未通过垫522摩擦产热。图24B为图24A的超声手术器械的一个实施例的端视图。该构型可以为背切模式,例如,其中标准有效长度(四分之一振动波波长(λ/4))可用于未通过夹臂组件510将组织压到刀片主体504上的背切和/或凝固。
图25A为处于打开位置和非工作状态的超声手术器械500的一个实施例的局部侧视图,其中垫522设置在延伸元件520上的波节532处。处于关闭位置(未示出)时,垫522将在波节间隙内与刀片主体504接合,并以波节532为中心。图25B为处于打开位置和非工作状态的超声手术器械500的一个实施例的局部侧视图,其中垫522设置在延伸元件520上,并从波节532向远端偏离。图25C为处于打开位置和非工作状态的超声手术器械500的一个实施例的局部侧视图,其中垫522设置在延伸元件520上,并从波节532向近端偏离。图25D为处于打开位置和非工作状态的超声手术器械500的一个实施例的局部侧视图,其中垫522设置在延伸元件520上并横跨波节532,同时具有与图25A-C的实施例所示的垫522不同的长度。本领域的普通技术人员将认识到,垫522相对于波节532的长度、宽度、厚度和偏移可以变化,以达到预定的效果。例如,垫522的位置和尺寸的灵活性允许为给定应用设计沿刀片502摩擦产生的额外热量的分布图。
垫522可由压到超声手术刀片502上时适于摩擦生热的任何已知材料制成。用于垫522的示例性材料包括具有高熔融温度和高有效摩擦系数的聚合材料。聚酰亚胺便是这样一种示例性材料。此外,垫522可以为延伸元件520的凸起区域。在多个实施例中,延伸元件520和垫522可以一体式构造由相同材料制成连续元件。
垫522的其他优点包括:可以为具有增加的裸露长度的超声手术刀片502提供机械支持。就这一点而论,垫522起双重作用:当夹臂组件510处于关闭位置(参见图23A和23B)且垫与激活的刀片主体504接合时,一方面产生热量以填充波节能隙,另一方面支撑挠曲的刀片502上增加的机械负荷。
图26A-E示出了单元件端部操纵装置的多个实施例。图26A-C为具有设置在区域560中的内部腔体570的单元件端部操纵装置550的横截面侧视图。图26D-E为具有内部腔体570的单元件端部操纵装置550的横截面端视图。内部腔体570有效地减小了端部操纵装置550在区域560内的横截面积,从而有效地减小了该区域的声阻抗率值。声阻抗率值可以沿端部操纵装置550的长度急剧变化(图26A)或逐渐变化(图26B-C)。本发明并不限于如图26A-E所示的内部腔体570背景下的任何具体几何形状,这些附图示出了具有不同的非限制性几何形状的内部腔体570。在多个实施例中,端部操纵装置550可以具有包含单一材料的一体式构造,该构造具有成形于其中的内部腔体570。在多个实施例中,端部操纵装置550可以具有多个不连续的内部腔体570(未示出)。在多个实施例中,端部操纵装置550可以沿着端部操纵装置550的轴具有一个或多个孔,这些孔开向端部操纵装置550的外表面,并使端部操纵装置550的横截面积减小。
在多个实施例中,端部操纵装置可以具有一体式实心构造,其包含单一材料并且不含腔体,其中端部操纵装置的声阻抗率沿其长度逐渐变化或急剧变化。在这些实施例中,可以通过冷处理端部操纵装置,沿端部操纵装置的长度方向形成所需的声阻抗率分布。
在多个实施例中,超声手术器械内结合了用于跨越和填充波节间隙的方法和技术。例如,在多个实施例中,超声手术器械可同时具有设置在夹臂组件上的组织垫插入段和设置在延伸元件上的垫。在其他实施例中,超声手术器械可以具有位于夹臂组件上的组织垫插入段和具有插入段的端部操纵装置,其中插入段具有相对较低的声阻抗率值和/或包含有损耗材料或高摩擦材料(或在端部操纵装置上的这类材料的涂层)。在又一个实施例中,超声手术器械可以具有设置在延伸元件上的垫和具有插入段的端部操纵装置,其中插入段具有相对较低的声阻抗率值和/或包含有损耗材料或高摩擦材料(或在端部操纵装置上的这类材料的涂层)。还可以设想到,超声手术器械可以具有设置在夹臂组件上的组织垫插入段、设置在延伸元件上的垫和具有插入段的端部操纵装置,其中插入段具有相对较低的声阻抗率值和/或包含有损耗材料或高摩擦材料(或在端部操纵装置上的这类材料的涂层)(图27)。本发明并不仅限于上述背景,并且可以设想出超声手术器械的所述构型的多种组合和/或修改形式。
图27为超声端部操纵装置700的一个实施例的局部侧视图,该超声端部操纵装置具有:设置在刀片716内的插入段710、设置在夹臂组件726的组织垫724内的组织垫插入段720,和设置在延伸元件736上的垫730。
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,无论在哪种情况下,都可对该器械进行修复,以便在至少使用一次后重复使用。修复可包括以下步骤的任何组合:拆卸器械,然后清洗或更换特定零件,以及重新组装。具体地讲,可拆卸该器械,并且可按照任何组合选择性地更换或拆下器械的任何数量的特定零件或部件。清洗和/或更换特定部件后,可在紧接外科手术之前在修复设备上或由外科手术团队将器械重新组装好,以供后续使用。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,本文所述的多个实施例将在手术之前进行。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,将该器械置于闭合并密封的容器中,例如塑料或
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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。
器械优选地经过消毒。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。
虽然本文已经描述了多个实施例,但可以对这些实施例进行许多修改和变型。例如,可以采用不同类型的端部操纵装置。此外,对于针对某些元件公开的材料,也可以使用其他材料。上述具体实施方式和以下权利要求旨在涵盖所有这类修改形式和变型形式。
谈到以引用方式全文或部分并入本文的任何专利、出版物或其他公开材料,只能在下列前提下并入本文:即被并入的材料不与本公开提出的现有定义、陈述或其他公开材料相冲突。就这点而论,必要时,本文明确提出的公开内容将取代以引用方式并入本文中的任何相冲突的材料。对于谈到以引用方式并入本文但又与本文提出的现有定义、陈述或其他公开材料相冲突的任何材料或其部分,将只能在被并入的材料与现有公开材料不冲突的情况下并入本文。

Claims (61)

1.一种与超声手术器械配合使用的端部操纵装置,包括:
具有第一声阻抗率值的第一部分;以及
具有不同于所述第一声阻抗率值的第二声阻抗率值的第二部分。
2.根据权利要求1所述的端部操纵装置,其中所述第二声阻抗率值小于所述第一声阻抗率值。
3.根据权利要求1所述的端部操纵装置,其中:
所述第一部分具有近端段和远端段;并且
所述第二部分具有插入段;
其中,所述插入段位于所述近端段和所述远端段之间。
4.根据权利要求3所述的端部操纵装置,其中所述近端段和所述远端段均包含第一材料,而所述插入段则包含第二材料。
5.根据权利要求3所述的端部操纵装置,其中所述插入段在所述端部操纵装置上某个区域内具有材料涂层。
6.根据权利要求3所述的端部操纵装置,其中所述远端段、所述近端段和所述插入段具有相配的横截面积。
7.根据权利要求3所述的端部操纵装置,其中所述插入段的横截面积小于所述近端段和所述远端段的横截面积。
8.根据权利要求7所述的端部操纵装置,其中所述插入段具有内部腔体。
9.根据权利要求3所述的端部操纵装置,其中所述插入段的设置位置对应于波节间隙的位置。
10.根据权利要求3所述的端部操纵装置,其中所述插入段包含铝或铝合金,并且所述近端段和所述远端段包含不锈钢。
11.根据权利要求3所述的端部操纵装置,其中所述插入段包含铝或铝合金,并且所述近端段和所述远端段包含钛或钛合金。
12.根据权利要求1所述的端部操纵装置,其中所述端部操纵装置包括超声手术刀片。
13.根据权利要求12所述的端部操纵装置,其中所述超声手术刀片具有:
限定纵向轴线的主体,所述主体具有近端和远端,其中所述远端能够通过换能器产生的振动沿所述纵向轴线移动;
从所述近端延伸到所述远端的处理区域;
基本平坦而宽阔的顶部表面;以及
底部表面。
14.一种与超声手术器械配合使用的端部操纵装置,包括:
由第一声阻抗材料构成的远端段;
由第二声阻抗材料构成的远端插入段;
由第三声阻抗材料构成的中间插入段;
由第四声阻抗材料构成的近端插入段;以及
由第五声阻抗材料构成的近端段。
15.根据权利要求14所述的端部操纵装置,其中所述第二声阻抗材料与所述第四声阻抗材料相同。
16.根据权利要求14所述的端部操纵装置,其中所述第二声阻抗材料与所述第四声阻抗材料不同。
17.根据权利要求14所述的端部操纵装置,其中所述第一声阻抗材料与所述第五声阻抗材料相同。
18.根据权利要求14所述的端部操纵装置,其中所述第一声阻抗材料与所述第五声阻抗材料不同。
19.根据权利要求14所述的端部操纵装置,其中所述第三声阻抗材料具有比所述第一声阻抗材料、所述第二声阻抗材料、所述第四声阻抗材料和所述第五声阻抗材料更大的声阻抗值。
20.根据权利要求14所述的端部操纵装置,其中所述第一声阻抗材料、所述第三声阻抗材料和所述第五声阻抗材料均具有比所述第二声阻抗材料和所述第四声阻抗材料更大的声阻抗值。
21.根据权利要求14所述的端部操纵装置,其中所述第三声阻抗材料具有比所述第一声阻抗材料和所述第五声阻抗材料更大的声阻抗值,并且其中所述第二声阻抗材料和所述第四声阻抗材料具有比所述第一声阻抗材料和所述第五声阻抗材料更低的声阻抗值。
22.根据权利要求14所述的端部操纵装置,其中所述中间插入段的设置位置对应于波节的位置。
23.一种具有多个段的超声手术刀片,其中所述段中的至少一个被配置成填充和/或收窄波节能隙。
24.根据权利要求23所述的超声手术刀片,其中所述段中的至少一个被配置成通过增大波节区内的超声位移收窄所述波节能隙。
25.根据权利要求23所述的超声手术刀片,其中所述段中的至少一个被配置成:通过增大所述手术刀片在波节区内的纵向运动、横向运动和扭转运动中的至少一者来收窄所述波节能隙。
26.根据权利要求23所述的超声手术刀片,其中所述段中的至少一个被配置成:通过所述手术刀片的纵向运动、横向运动和扭转运动中的至少一者所摩擦产生的热量来填充所述波节能隙。
27.根据权利要求23所述的超声手术刀片,其中所述段中的至少一个被配置成:通过所述手术刀片的纵向运动、横向运动和扭转运动中的至少一者所摩擦产生的热量,以及通过增大波节区内的超声位移来填充和收窄所述波节能隙。
28.根据权利要求23所述的超声手术刀片,其中所述段中的至少一个包括涂有高摩擦系数材料的一部分刀片。
29.根据权利要求23所述的超声手术刀片,其中所述段中的至少一个包括涂有声音有损耗材料的一部分刀片。
30.根据权利要求23所述的超声手术刀片,其中所述段中的至少一个包括经冷处理的一部分刀片。
31.根据权利要求23所述的超声手术刀片,其中所述段中的至少一个包括由于所述刀片内的内部腔体而具有较小横截面积的一部分刀片。
32.根据权利要求23所述的超声手术刀片,还包括:
近端段;
远端段;以及
插入段;
其中所述插入段位于所述近端段和所述远端段之间,并且所述插入段被配置成填充和/或收窄所述波节能隙。
33.根据权利要求32所述的超声手术刀片,其中所述插入段具有声音有损耗材料;并且其中所述插入段的设置位置对应于波节间隙的位置;并且其中所述插入段被配置成产生并传导热量,以填充所述波节间隙。
34.根据权利要求32所述的超声手术刀片,其中所述插入段包含声阻抗率值小于所述近端段的所述声阻抗率值和所述远端段的所述声阻抗率值的材料。
35.一种包含单一材料并具有一定长度的超声手术刀片,其中所述刀片的所述声阻抗率沿所述长度变化。
36.根据权利要求35所述的超声手术刀片,其中所述刀片的所述声阻抗率由于所述手术刀片中的内部腔体而急剧变化。
37.根据权利要求35所述的超声手术刀片,其中所述刀片的所述声阻抗率在所述手术刀片的经过冷处理的区域内急剧变化。
38.根据权利要求35所述的超声手术刀片,其中所述刀片的所述声阻抗率由于所述手术刀片中的内部腔体而逐渐变化。
39.根据权利要求35所述的超声手术刀片,其中所述刀片的所述声阻抗率由于所述手术刀片的冷处理而逐渐变化。
40.根据权利要求35所述的超声手术刀片,其中所述刀片的所述声阻抗率沿所述长度逐渐变化,并且在沿着所述长度对应于波节间隙的位置处具有局部最小值。
41.根据权利要求35所述的超声手术刀片,其中所述刀片的所述声阻抗率沿所述长度逐渐变化,并且在沿着所述长度对应于波节间隙的位置处具有局部最大值。
42.一种手术器械,包括:
换能器,所述换能器被配置成沿纵向轴线以预定频率产生振动;
超声刀片,沿所述纵向轴线延伸的所述超声刀片连接到所述换能器,其中所述超声刀片包括具有近端和远端的主体,其中所述远端能够通过所述换能器产生的所述振动沿所述纵向轴线移动;以及
不振动夹臂组件,所述不振动夹臂组件具有近端和远端,并且可枢转地设置在所述主体附近,其中所述夹臂组件能够从打开位置可枢转地运动到关闭位置,其中所述不振动夹臂组件包括近侧组织垫段、远侧组织垫段和组织垫插入段,其中所述组织垫插入段设置在所述近侧组织垫段和所述远侧组织垫段之间。
43.根据权利要求42所述的手术器械,其中当所述夹臂组件处于关闭位置时,所述组织垫插入段的设置位置对应于波节间隙区。
44.根据权利要求42所述的手术器械,其中当所述夹臂组件处于关闭位置时,所述组织垫插入段的设置位置偏离波节间隙。
45.根据权利要求42所述的手术器械,其中所述组织垫插入段高于所述近侧组织垫段和所述远侧组织垫段的标称高度。
46.根据权利要求42所述的手术器械,其中所述夹臂组件还包括偏压装置,所述偏压装置被配置成当所述夹臂组件处于关闭位置时,以相对于所述近侧组织垫段和所述远侧组织垫段更大的力将所述组织垫插入段压到所述刀片上。
47.根据权利要求46所述的手术器械,其中所述偏压装置包括片簧。
48.根据权利要求42所述的手术器械,其中所述插入段包含聚酰亚胺。
49.根据权利要求42所述的手术器械,其中所述近侧组织垫段和所述远侧组织垫段包含聚四氟乙烯。
50.一种手术器械,包括:
换能器,所述换能器被配置成以预定频率沿纵向轴线产生振动;
超声刀片,沿所述纵向轴线延伸的所述超声刀片连接到所述换能器,其中所述超声刀片包括具有近端和远端的主体,其中所述远端能够通过所述换能器产生的所述振动相对于所述纵向轴线运动;以及
延伸元件,所述延伸元件包括近端和远端,并且设置在所述主体附近,其中所述延伸元件还包括垫,所述垫朝向所述延伸元件的所述远端设置,并位于所述主体和所述延伸元件的所述远端之间。
51.根据权利要求50所述的手术器械,其中所述垫包含聚酰亚胺。
52.根据权利要求50所述的手术器械,还包括不振动夹臂组件,所述不振动夹臂组件具有近端和远端,并且可枢转地设置在所述主体附近,其中所述夹臂组件能够从打开位置可枢转地运动到关闭位置。
53.根据权利要求52所述的手术器械,其中当所述夹臂组件处于所述关闭位置时,所述刀片发生挠曲并与所述垫接合。
54.根据权利要求52所述的手术器械,其中当所述夹臂组件处于所述关闭位置时,所述垫的设置位置对应于波节间隙。
55.根据权利要求52所述的手术器械,其中当所述夹臂组件处于所述关闭位置时,所述垫的设置位置偏离波节间隙。
56.一种手术器械,包括:
换能器,所述换能器被配置成以预定频率沿纵向轴线产生振动;
超声刀片,沿所述纵向轴线延伸的所述超声刀片连接到所述换能器,其中所述超声刀片包括具有近端和远端的主体,其中所述远端能够通过所述换能器产生的所述振动沿所述纵向轴线移动;以及
护套,所述护套包括近端和远端,并设置在所述主体附近,其中所述护套还包括垫,所述垫朝向所述护套的所述远端设置,并位于所述主体和所述护套的所述远端之间。
57.根据权利要求56所述的手术器械,其中所述垫包含聚酰亚胺。
58.根据权利要求56所述的手术器械,还包括不振动夹臂组件,所述不振动夹臂组件具有近端和远端,并且可枢转地设置在所述主体附近,其中所述夹臂组件能够从打开位置可枢转地运动到关闭位置。
59.根据权利要求58所述的手术器械,其中当所述夹臂组件处于所述关闭位置时,所述刀片发生挠曲并与所述垫接合。
60.根据权利要求58所述的手术器械,其中当所述夹臂组件处于所述关闭位置时,所述垫的设置位置对应于波节间隙。
61.根据权利要求58所述的手术器械,其中当所述夹臂组件处于所述关闭位置时,所述垫的设置位置偏离波节间隙。
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