CN101772326A - 具有调制器的超声外科器械 - Google Patents

具有调制器的超声外科器械 Download PDF

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CN101772326A
CN101772326A CN200880101526A CN200880101526A CN101772326A CN 101772326 A CN101772326 A CN 101772326A CN 200880101526 A CN200880101526 A CN 200880101526A CN 200880101526 A CN200880101526 A CN 200880101526A CN 101772326 A CN101772326 A CN 101772326A
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F·B·斯图伦
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Ethicon Endo Surgery Inc
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    • A61B17/22004—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
    • A61B17/22012—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
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    • A61B17/22012—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
    • A61B2017/22014—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement the ultrasound transducer being outside patient's body; with an ultrasound transmission member; with a wave guide; with a vibrated guide wire
    • A61B2017/22015—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement the ultrasound transducer being outside patient's body; with an ultrasound transmission member; with a wave guide; with a vibrated guide wire with details of the transmission member
    • A61B2017/22018—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement the ultrasound transducer being outside patient's body; with an ultrasound transmission member; with a wave guide; with a vibrated guide wire with details of the transmission member segmented along its length
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    • A61B2017/320095—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw with sealing or cauterizing means

Abstract

本发明公开了一种外科器械，该外科器械包括配置成沿着纵向轴线以预定频率产生振动的换能器(14)。端部执行器(50)适于连接到该换能器并沿着该纵向轴线延伸。该端部执行器包括具有近端和远端的主体。该远端可由该换能器产生的振动相对于该纵向轴线运动。驱动模块(600)连接到该换能器以产生调制驱动信号。该端部执行器的远端可响应由换能器响应调制驱动信号所产生的振动而运动。

Description

具有调制器的超声外科器械
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执行器的机械振动形式的能量来切割和/或凝固组织。以合适的能级并使用合适的端部执行器将超声振动传输至有机组织时，超声振动可以用于切割、解剖、提拉或凝固组织或将肌组织从骨骼上分离。利用实芯技术的超声器械尤其有利，是因为超声能量的量可以从超声换能器通过超声传输波导管传输到外科手术端部执行器。此类器械可以用于开放式手术或微创手术，例如内窥镜或腹腔镜手术，其中端部执行器穿过套针到达外科手术部位。
以超声频率激活或激励此类装置的端部执行器可引发纵向振动运动，从而可在相邻的组织内产生局部热量，有助于进行切割和凝固。由于超声器械的性质，可以将具体的超声激活的端部执行器设计为可执行多种功能，包括(例如)切割、夹紧和凝固。
通过(例如)电激励换能器，可以在外科手术端部执行器内引发超声振动。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。换能器部分产生的振动经由从换能器部分延伸至外科手术端部执行器的超声波导管传输至外科手术端部执行器。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。当端部执行器连接到换能器上时，系统整体的频率可能与换能器本身的频率相同。
换能器和端部执行器可设计成在两个不同的频率共振，当接合或连接到一起时，可以第三个频率共振。端部执行器在顶端处的纵向超声振动的零-峰振幅d表现为共振频率的简单正弦曲线，用以下公式表示：
d＝Asin(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。
实芯超声手术器械可分为两类：单元件端部执行器和多元件端部执行器。单元件端部执行器包括诸如解剖刀(例如刀片、利钩刀片、解剖钩刀片、弯刀片)和球形凝固器等器械。当组织较软或支撑结构松散时，单元件端部执行器器械在施加刀片至组织的压力方面能力有限。要有效地将超声能量作用到组织上，必须提供较大压力。单元件端部执行器无法抓住组织导致施加超声能量时更加无法接合组织表面，造成凝固和组织接合低于预期。多元件端部执行器(例如夹紧凝固器)包括可将组织压在超声刀片上的机构，可以克服这些缺点。
超声夹紧凝固器为改善的用于切割/凝固组织(尤其是松散和无支撑组织)的超声外科器械，其中超声刀片与对组织施加压力或偏置力的夹具一起使用，使得组织的凝固和切割更快并且刀片的运动衰减较少。
端部执行器的远端，或者更具体地讲刀片，切割或凝固组织时与液体接触。液体可以包括冲洗液、血液、组织微粒和/或它们的任意组合。当超声致动的端部执行器的远端与液体接触时，刀片的远端会散发出液体微粒扩散流形式的细雾。细雾流会破坏外科手术部位的能见度，因此通常是不可取的。希望提供这样一种超声器械：当以超声频率的能量激活该超声器械时，端部执行器的远端散发出的细雾流减少。
发明内容
在一个实施例中，外科器械包括配置为可沿纵向轴线产生预定频率的振动的换能器。端部执行器适于连接到换能器并且沿纵向轴线延伸。端部执行器包括具有近端和远端的主体。所述远端可由所述换能器产生的振动相对于所述纵向轴线运动。驱动模块连接到换能器以产生调制的驱动信号。端部执行器的远端可响应由换能器响应调制驱动信号所产生的振动而运动。
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，通过结合下列附图以及下文的详述，才能最好地理解多个实施例的构造和操作方法。
图1A示出包括单元件端部执行器的超声系统的一个实施例。
图1B示出包括多元件端部执行器的超声系统的一个实施例。
图2示出用于超声器械的连接件/接头的一个实施例。
图3A示出可与图1A所示超声系统连接的单元件端部执行器超声手术器械的一个实施例的分解透视图。
图3B示出包括图1B所示的多元件端部执行器的夹紧凝固器的一个实施例。
图3C示出图1B和3B中所示的多元件端部执行器的透视图。
图4A示出用于驱动超声换能器的超声换能器驱动模块的一个实施例。
图4B示出图4A所示的超声换能器驱动模块的一个实施例产生的驱动信号。
图5示出通过由基本上恒定的振幅“A”和恒定的频率“f”的驱动信号驱动的超声致动端部执行器所产生的细雾流。
图6A示出具有调制功能的超声换能器驱动模块的一个实施例。
图6B示出图6A所示的超声换能器驱动模块的一个实施例产生的调制的驱动信号。
图7示出由图6A所示的具有调制功能的超声换能器驱动模块的一个实施例产生的调制的驱动信号驱动端部执行器的远端所散发出的细雾流。
图8示出具有相位调制功能的超声换能器驱动模块的一个实施例。
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，下文公开的外科器械和刀片构型仅是示例性的，并不旨在限制其范围或应用。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。
在一个一般性方面，多个实施例涉及具有调制器电路的外科器械以减少超声端部执行器的远端的细雾。外科器械包括配置为可沿纵向轴线产生预定频率的振动的换能器。超声刀片沿纵向延伸并连接到换能器。超声刀片包括具有近端和远端的主体。远端可由换能器产生的振动相对于纵向轴线运动。主体包括从近端延伸到远端的治疗区域。主体包括从近端突出、适于连接到换能器的颈部。调制器电路产生驱动信号，降低或减少细雾。
多个实施例通常涉及超声发生器和/或调制器电路，以控制从超声致动的端部执行器散发出的细雾流。在一个实施例中，超声发生器和/或调制器电路产生能够减少超声致动的端部执行器(例如刀片)的远端散发出的细雾流的调制驱动信号。调制驱动信号减少细雾流，从而改善手术期间手术部位的能见度。调制器电路配置为可调制驱动信号(例如电流或电压)的振幅、驱动信号的频率或者它们的任意组合。施加到端部执行器的调制驱动信号控制与端部执行器的远端接触的液滴颗粒受到的辐射压。调制驱动信号以不同的相对速率驱动距离端部执行器的远端不同的许多雾滴。雾滴间相对运动的差异使得雾滴很有可能互相碰撞并且使得雾滴聚结或球形化。雾滴聚结或球形至一定的尺寸时，重力将使得较大的雾滴从细雾流中掉下。从而降低细雾流的尺寸并提高外科手术部位的能见度。
超声手术器械的例子在美国专利No.5,322,055和5,954,736中有所公开，超声刀片和手术器械的组合在例如美国专利No.6,309,400B2、6,278,218B1、6,283,981B1和6,325,811B1中有所公开，全文以引用方式并入本文中。这些参考文献中公开的超声外科器械和刀片构造是激发刀片的纵向模式。由于其不对称性，这些刀片还可表现出横向和/或扭转运动，其中非纵向运动的特征性“波长”一般小于刀片及其延伸部分整体纵向运动的“波长”。因此，这种非纵向运动的波形将沿着组织执行器具有横向/扭转运动的波节位置，而工作的刀片沿其组织执行器的净运动不是零(即，将至少具有沿着从其远端(纵向运动的波腹)延伸至纵向运动的第一波节位置(邻近组织执行器部分)的长度的纵向运动)。
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器械和方法为非限制性的示例实施例，并且不同实施例的范围仅由权利要求书限定。结合一个示例性实施例示出或描述的特征可以与其它实施例的特征组合。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。
图1A示出包括单元件端部执行器的超声系统10的一个实施例。超声系统10和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、包括器械手把室16的器械手把组件60以及超声致动的单元件端部执行器或超声致动的刀片50。超声换能器14又称为“Langevin叠堆”，通常包括换能器部分18、第一共振器部分或钟形后部20以及第二共振器部分或钟形前部22，以及辅助元件。整体构造形成共振器。超声换能器14的长度优选地为波长二分之一的倍数(nλ/2，其中“n”为任意正整数，例如n＝1，2，3...)，本文将详细描述。声波组件24包括超声换能器14、前端锥体26、速度变换器28和表面30。
应当理解，本文使用的术语“近端”和“远端”是以临床医师手持器械手把组件60为参照的。因此相对于更近端的手把组件60而言，刀片50是远端。还应当理解，为了简洁明了，本文使用的诸如“顶部”和“底部”等空间术语也是相对于临床医师手持器械手把组件60而言。然而，手术器械的使用方向和位置多种多样，这些术语非旨在限制和绝对化。
钟形后部20的远端连接到换能部分18的近端，而钟形前部22的近端连接到换能部分18的远端。钟形前部22和钟形后部20的长度由换能部分18的厚度、制造钟形后部20和钟形前部22的材料密度和弹性模量以及超声换能器14的共振频率等一些变量决定。钟形前部22可像速度变换器28一样，从其近端到其远端向内成锥形以放大超声振幅，也可以没有放大作用。合适的振动频率范围可从约20Hz至120Hz，而最适合的振动频率范围可为约30-100kHz。在一个实例中，工作振动频率可为大约55.5Hz。
压电元件32可以用任何合适的材料制成，例如锆-钛酸铅、偏铌酸铅、钛酸铅、钛酸钡或其他压电陶瓷材料。每一个正电极34、负电极36和压电元件32都有从中心延伸的腔体。正电极34和负电极36分别与导线38和40电连接。导线38和40包在电缆42内，并与超声系统10的超声信号发生器12电连接。具有调制功能的超声换能器驱动模块600可以位于超声信号发生器12内或是器械手把组件60内。实施例并非仅限于此。
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，该机械能主要致使超声换能器24和刀片50出现以超声频率纵向振动运动的声学驻波。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，声波组件24产生振动运动驻波。系统设计在共振下运行，使得产生振幅的声学驻波样式。沿着声波组件24的任何点处的振动运动振幅取决于沿着声波组件24测量振动运动的位置。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)。
导线38和40从超声信号发生器12将电信号传输到正电极34和负电极36。由响应(例如脚踏开关44等)激活元件或其他致动器的超声信号发生器12提供电信号为压电元件32供电，在声波组件24中产生声学驻波。该电信号使压电元件32产生反复小位移形式的扰动，在材料中导致大的交替压缩和张力。该反复小位移引起压电元件32沿电压梯度的轴以连续的方式伸展和收缩，产生超声能量的纵波。经由超声传输波导管104，超声能量通过声波组件24传输至刀片50。
为了使声波组件24递送能量到刀片50，声波组件24的所有元件必须与刀片50声波连接。超声换能器14的远端可使用诸如双头螺栓48等螺纹连接与超声传输波导管104的近端在表面30处声波连接。
声波组件24的元件经过优选地调音，使得任何组件的长度均为二分之一波长(nλ/2)的倍数，其中波长λ是声波组件24的预选或运行的纵向振动驱动频率fd的波长。还可构思声波组件24可整合任何合适构造的声波元件。可超声致动的刀片50的长度可基本上等同于二分之一系统波长(nλ/2)的倍数。
超声刀片50的远端52可设置在波腹附近，以便提供远端的最大纵向偏移。当换能器组件通电时，超声刀片50的远端52可配置为以例如55.5kHz的预定振动频率在例如大约10至500微米峰到峰的范围内运动，优选地在约30至150微米的范围内运动。
超声刀片50可连接到超声传输波导管104。如图所示的超声刀片50和超声传输波导管104使用例如Ti6Al4V(一种含铝和钒的钛合金)、铝、不锈钢、其他已知材料等适合超声能量传输的材料形成单体构造。超声刀片50也可以与超声传输波导管104分开并且使用不同的组合物，通过(例如)双头螺栓、焊接、粘合剂、快速连接或其他合适的已知方法连接这两个组件。超声刀片50可以包括单元件(例如，解剖刀或者球形凝固器)或者包括多元件(例如夹紧凝固器)。超声传输波导管104的长度可基本上等同于例如二分之一系统波长(nλ/2)的倍数。超声传输波导管104可优选地由使用例如钛合金(即Ti6Al4V)或铝合金等适合高效传输超声能量的材料制造的实芯轴加工而成。
超声传输波导管104包括纵向凸出的近端54，其通过任何合适的连接手段连接到超声波传输导管104的表面30。在不同的实施例中，超声传输波导管104的近端54可以通过由双头螺栓、焊接、粘合剂、快速连接或其他合适的已知方法形成的连接/联合接头连接到表面30。在图1A所示的实施例中，超声传输波导管104的近端54可通过螺纹连接(例如双头螺栓48)连接到表面30。超声传输波导管104包括位于多个波节上的多个稳定硅胶环或适形的支撑56。硅胶环56抑制不可取的振动并将超声能量与可移除的护套58隔离，以确保纵向的超声能量流以最大的效率到达刀片50的远端52。
如图1A所示，外护套58保护用户以及患者不受超声传输波导管104超声振动的影响。护套58通常包括套节62和细长的管状构件64。管状构件64连接到套节62上并且具有纵向延伸的开口。护套58螺纹连接到外壳16的远端。超声传输波导管104经过管状构件64的开口延伸，而硅胶环56将超声传输波导管104与外护套58隔离。外护套58可使用隔离销轴112连接到超声传输波导管104。超声传输波导管104中的孔可以名义上靠近位移波节。超声传输波导管104借助双头螺栓48螺纹连接到器械手把组件60上。形成于套节62上的平坦部位使得手把组件60能够扭转到所需水平。
护套58的套节62优选地使用塑料制造，而管状构件64使用不锈钢制成。作为另外一种选择，超声传输波导管104可包括环绕在其周围的聚合材料，避免其与外部接触。
在图1A所示的实施例中，超声传输波导管104的远端包括形成为一体式部件的刀片50。在其他实施例中，超声传输波导管104的远端可通过内部螺纹连接可拆卸地连接到刀片50的近端，优选地位于或靠近波腹。在该实施例中，可构思刀片50通过诸如焊接接头或类似方法等任何合适的手段连接到超声传输波导管104上。然而，实施例并不仅限于此。
图1B示出包括多元件端部执行器的超声系统1000的一个实施例。超声系统1000的一个实施例包括与图1A描述的超声换能器14连接的超声发生器12。超声换能器14连接到包括器械外壳1004的夹紧凝固刀头1002。声波组件18向多元件器械的多元件端部组件1008的端部执行器1016(图3B)输送能量。为了使声波组件18将能量输送到多元件端部执行器或多元件端部组件1008，声波组件18的所有元件必须与夹紧凝固刀头1002的超声激活部分声波连接。因此，超声换能器14的远端可使用螺纹连接的双头螺栓48与超声传输波导管104的近端在表面30处声波连接。
正如前面结合图1A所示的超声系统10所讨论的那样，声波组件18的元件经过优选地调音，使得任何组件的长度是二分之一波长(nλ/2)的倍数，其中波长λ是声波组件18的预选或运行的纵向振动驱动频率fd的波长。声波组件18可整合任何合适构造的声波元件。
图2示出超声器械的连接接头70的一个实施例。连接接头70可在超声传输波导管104的近端54和位于声波组件24远端的速度变换器28的表面30之间形成。超声传输波导管104的近端54包括接纳部分螺纹双头螺栓48的近似圆柱形的内螺纹表面66。速度变换器28的远端还可包括接纳部分螺纹双头螺栓40的近似圆柱形的内螺纹表面68。表面66和68为近似圆形并纵向对齐。
图3A示出单元件端部执行器超声手术器械100的一个实施例的分解透视图。超声手术器械100可与图1A所示的超声系统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，在不脱离本发明范围的前提下，能够想到本文公开的超声手术器械的多个实施例及其任何等效结构与其他已知的超声手术器械有效地联用。因此，对本文所公开的多个超声手术刀片实施例进行保护的范围不应仅限于与上述示例性超声手术器械联用。
在图3A示出的实施例中，细长的传输元件显示为超声波导管104，端部执行器显示为适合切割和/或凝固组织的单元件端部执行器或刀片50。刀片50可以为对称的或非对称的。
刀片50的长度可基本上等同于二分之一系统波长(nλ/2)的倍数。刀片50的远端52可设置在波腹附近，以提供远端52的最大纵向偏移。当换能器组件通电时，刀片50的远端52可配置为以预定的振动频率例如在大约10至500微米峰到峰的范围内运动，并且优选地在约30至150微米的范围内运动。
刀片50可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使用例如Ti6Al4V(一种含铝和钒的钛合金)、铝、不锈钢、其他已知材料或它们的组合等适合超声能量传输的材料形成单体构造。刀片50也可以与超声传输波导管104分开并且使用不同的组合物，通过(例如)双头螺栓、焊接、粘合剂、快速连接或其他合适的已知方法连接这两个组件。超声传输波导管104的长度可基本上等同于例如二分之一系统波长(nλ/2)的倍数。超声传输波导管104还可优选地由使用例如钛合金(例如Ti6Al4V)或铝合金等适合高效传播超声能量的材料制造的实芯轴加工而成。超声传输波导管104也可由类似材料制造的空芯轴加工而成。超声传输波导管104还可以使用实芯/空芯轴组合加工而成，例如使用在轴长度方向的多个位置有空腔的实芯轴。
在图3A所示的实施例中，超声传输波导管104通过固定性O形环108和密封环110设置在外护套58中。在其他实施例中，一个或多个附加避震器或支撑构件(未示出)也可以与超声传输波导管104一起包括在内。超声传输波导管104通过穿过外护套58中的安装孔114和超声传输波导管104中的安装孔116的固定销轴112附连到外护套58上。
图3B示出包括在图1B所示的多元件端部执行器内的夹紧凝固刀头1002的一个实施例。图3C示出图1B和3B中所示的多元件端部执行器的透视图。结合图1B、3B和3C，夹紧凝固刀头1002可优选地连接到声波组件18上形成单体并可从上面拆下。夹紧凝固刀头1002的远端优选地与声波组件18的远端表面30声波连接。夹紧凝固刀头1002可使用任何合适的装置连接到声波组件18上。
夹紧凝固刀头1002优选地包括器械外壳1004和细长构件1006。细长构件1006可选择性地相对于器械外壳1004旋转。器械外壳1004包括枢转柄部1028和固定柄部1029。
在器械外壳1004的腔体设置有转位机构(未示出)。转位机构优选地附连或连接到内管1014，将枢转柄部1028的运动转换为内管1014的线性运动，以打开和关闭多元件端部执行器1008。当枢转柄部1028移向固定柄部1029时，转位机构将内管1014向后滑动，将多元件端部执行器1008绕枢轴转动到关闭位置。枢转柄部1028的反向运动使转位机构滑动，向相反方向(即向前)转移内管1014，从而按图3B所示的箭头1020方向将多元件端部执行器1008绕枢轴转动到打开位置。
枢转柄部1028包括拇指套环1030。枢轴销1032穿过枢转柄部1028的第一孔洞，以便可以按图3B中箭头1034所示进行枢转。当枢转柄部1028的拇指套环1030移到远离器械外壳1004的箭头1034方向，内管1014向后滑动，将多元件端部执行器1008绕枢轴转动到关闭位置。
夹紧凝固刀头1002的细长构件1006从器械外壳1004向外延伸。细长构件1006优选地包括外管1012的外部构件、内管1014的内部构件和传输部件或超声传输波导管104。
多元件端部执行器或多元件端部夹臂组件1008包括夹臂组件1018、组织垫1036和超声刀片1016。夹臂组件1018绕枢轴销(未示出)枢转地安装，以便按箭头1038所示的方向旋转。超声刀片1016包括向内延伸到刀片主体的锥形凹表面1040。
超声手术器械100和夹紧凝固刀头1002可以按本领域已知的方法消毒，例如伽玛射线消毒、环氧乙烷处理、高压灭菌法、在消毒液中浸泡或者其他已知方法。在图1A和3A示出的实施例中，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执行器或刀片50。刀片50和超声传输波导管104示出为单体构造，使用前文讨论过的适合超声能量传输的材料(例如Ti6Al4V、铝、不锈钢或其他已知材料)制成。刀片50也可以与超声传输波导管104分开并且使用不同的组合物，通过(例如)双头螺栓、焊接、粘合剂、快速连接或其他已知方法连接这两个组件。在图1B和3B所示的实施例中，夹紧凝固刀头1002的超声传输组件1024包括连接到超声传输波导管104的多元件端部执行器1008。超声传输波导管104的长度可基本上等同于例如二分之一系统波长(nλ/2)的倍数。超声传输波导管104可优选地由使用例如钛合金(即Ti6Al4V)或铝合金等适合高效传输超声能量的材料制造的实芯轴加工而成。
图4A示出用于驱动超声换能器14的超声换能器驱动模块400的一个实施例。由超声换能器驱动模块400的一个实施例产生的驱动信号404如图4B所示。参照图4A和图4B，超声换能器驱动模块400可为超声信号产生器12的部件。超声换能器驱动模块400的电流控制回路402控制驱动信号404的调制，驱动信号404连接到换能器14上。控制回路402为锁相环路(PLL)，使加载到阻性负载(即换能器14)上的电流(i)和电压(v)偏移为0度。驱动信号404改变换能器14的振幅从而改变刀片50的远端52的纵向偏移。电流控制回路402中的加法器模块406执行加法功能并且产生误差信号408，该信号代表传输到换能器14、由电流测量模块412(例如，均方根或者RMS)测得的电流410与由电流设定点模块416设定的所需设定点电流414之间的差异。控制器418监控误差信号408以增加或者减少传输到放大器420的输入电压419。放大器420增加或者减少驱动信号404的电压，以驱动误差信号408为零。
在没有调制的情况下，超声换能器驱动模块400产生的驱动信号404具有基本恒定的振幅“A”。控制回路402基于选择的为约0至100％的功率水平，使驱动电流410振幅“A”维持为恒定电流(例如，得自EthiconEndo-Surgery，Inc.(Cincinnati，Ohio)的GEN04)。因此，即使当刀片尖端承受组织的“重负荷”，刀片50的远端52的速度仍然保持为几乎恒定，从而辐射压保持恒定。同样地，即使刀片50的远端52升温时，频率“f”可能略微下降，但是频率“f”仍然保持相对恒定。这就意味着雾滴602的尺寸“d”也保持不变。因此，雾滴经受基本上相同的辐射和声压以及相同的惯性力和流体拉力。因此，雾滴以相同的动作进行运动，不太容易互相碰撞和聚结。
图5示出由基本恒定的振幅“A”和恒定的频率“f”的驱动信号驱动的超声致动的端部执行器产生的细雾流500。如上所述，当超声外科器械100的刀片50的远端52与液体接触时，细雾流500从刀片50的远端52散发出。细雾流500由以基本恒定速率503进行运动并且各自相对均匀的雾滴502形成。细雾流500限制外科医生清楚地观察最关注的区域。当超声刀片50被激活以凝固和横切组织时，产生细雾流500。因此，细雾流500就产生于手术部位。可以通过降低刀片50的远端52的振动振幅来减少细雾流500。但是，这样并不会消除细雾流500，并且多种应用可能要求更高的振幅。因此，对于超声外科手术端部执行器50来说，仍然无法消除细雾流500。
当由常规超声驱动信号驱动时，超声刀片50产生类似于图5所示形状的细雾流500。可以通过改变超声驱动信号进而将形成细雾流500的雾滴502凝聚起来，从而改变细雾流500的形状。凝聚是指雾滴502由于湿气、静电荷或者化学或机械粘合的作用粘附为一小团。雾滴502凝聚是这样一个过程：较小的雾滴502互相碰撞或接触，聚结成更大更重的液滴，然后雾滴502沉淀。过去(大约20世纪50年代)所做的工作已经表明采用超声能量通过凝聚处理对机场跑道进行除雾的方法是可行的。这类大型系统的实际操作不太可能，因为执行该方法需要很大的能量以及必须数量和尺寸的超声警报器。根据雾滴凝聚的原理，超声换能器驱动模块400可配置为产生超声能量，减少从超声刀片50的远端52发出的细雾流500。
超声刀片50的远端52被超声信号发生器12激活时会产生辐射压。由于材料的非线性，辐射压是超声振动在气体和液体中产生的静压。理想气体中的辐射压取决于介质中的平均能量，表示为<E>。平均能量<E>与远端介质中的速度的平方成比例。辐射压Pr与<E>的关系可用下列等式(1)、(2)和(3)公式化地表示：
P r = &gamma; + 1 4 &CenterDot; < E > - - - ( 1 )
< E > = 1 2 &CenterDot; &rho; o v 2 - - - ( 2 )
v＝ω·d    (3)
可根据以下物理行为模型来定义形成细雾流500的雾滴502的尺寸。虽然形成雾(即，液体的雾化)有着相当复杂的物理知识，但是在大多数规律中，液滴的平均直径“d”可根据等式(4)来公式化地定义。
d = 0.34 ( 8 &pi; &CenterDot; T &rho; o &CenterDot; f 2 ) 1 3 - - - ( 4 )
其中，T为表面张力，ρo为液体(流体)的密度，“f”为振动频率。根据等式(4)，雾滴的粒径“d”与频率“f”的2/3次方成反比。这意味着，随着频率“f”增大，雾滴502的粒径“d”减小。存在关于上述等式(4)给出的平均尺寸的雾滴粒径的分布。但是该分布比较紧密，所以分布中的雾滴502的粒径“d”几乎一致。
细雾流500中的雾滴502的粒径在较大的范围内分布并且潜在地分层。当振动源(例如超声驱动刀片50)产生的场穿透细雾流500时，不同粒径的雾滴不同地响应振动场。由于雾滴502在振动场内的位置及其粒径，借助惯性力和流体拉力，雾滴502以不同的速率沿不同方向进行运动，导致雾滴颗粒502相互碰撞和潜在聚结。达到一定程度后，雾滴502增大的粒径足以使较大较重的雾滴由于增大的重力而“掉下”。
图6A示出具有调制功能的超声换能器驱动模块600的一个实施例。图6B示出超声换能器驱动模块600的一个实施例产生的调制驱动信号604。参照图6A和图6B，超声换能器驱动模块600可为超声信号产生器12的一个实施例的元件。超声换能器驱动模块600的电流控制回路402控制驱动信号604的调制，驱动信号604连接到换能器14。超声换能器驱动模块600产生驱动信号604并且将总“RMS”电流410传输到换能器14。随着负载的增加，电流控制回路402加大驱动信号604的电压。驱动换能器14的驱动信号604保持与振幅“A”一样的正弦曲线，电流控制回路402将RMS电流维持为等同于设定点模块416设定的电流设定点信号414。
调制器608将调制波形606(在图6B中以虚线示出，重叠于调制驱动信号604上)调制到电流设定点信号414上。调制波形606“Sm”可表示为：
Sm＝1+Am·sin(2π·fm·t)              (5)
调制波形606“Sm”包括调幅分量“Am”和调频分量“fm”。在图6A所示的实施例中，驱动换能器14的正弦驱动信号604为变化振幅正弦波信号。调制器608将缓慢变化的振幅分量施加到正弦驱动信号604上。将调制器608的调制信号610提供至加法器模块406的输入端。控制回路402迫使RMS电流等于由设定点电流414分量和调制波形606分量形成的调制信号610。可选择响应控制回路402的频率以跟踪负载(例如换能器14)的变化，该频率应该大于调频“fm”。
施加到驱动信号604的调制波形606会调制换能器14的振动从而调制刀片50的纵向偏移。调制波形606的形状影响形成从刀片50的远端52散发出的细雾流500的雾滴502的相对运动。施加到驱动信号604的调制波形606可以采用缓慢变化的交流电(AC)信号的形式来缓慢改变电流设定点模块416施加的设定点电流414。可以选择调制波形606的频率使其远远小于超声换能器14的共振频率“f”并且比电流控制回路402相关的时间常数更慢。对于控制回路402，调制波形606应为电流设定点模块416产生的变化设定点信号而非需要纠正的误差信号。在一个实施例中，调制波形606可以采用正弦信号的形式。但在其他实施例中，调制波形606可以采用锯齿波、方波或者任何合适波形的形式。
调制波形606的形状影响形成细雾流500的雾滴502之间的相对运动，在没有调制的情况下其由恒定振幅“A”和恒定频率“f”的驱动信号404产生。在没有调制波形施加到驱动信号404时，雾滴502的尺寸基本相同。雾滴502的尺寸基本一致是因为雾滴以相同的辐射压和由此产生的相同相对速率或相对运动从刀片50的远端52散发出。具有高波峰因数的调制波形会对细雾流500的雾滴502的相对运动产生不同和更明显的影响。但是会达到平衡，因为不同类型的调制波形可能具有干扰控制回路402运行的更高频率分量。
图7示出图6A所示的具有调制功能的超声换能器驱动模块600的一个实施例产生的调制驱动信号604驱动刀片50的远端52散发出的细雾流70。细雾流700示出调制驱动信号404、604施加到刀片50的远端52上对雾滴702a-n产生的效果；其中，n为表示细雾流700中雾滴总数的整数。为了方便明了地示出，雾滴702a-n的粒径大小有差异而非基本上一致，与未经调制的、形成细雾流500(图5)的雾滴502不同。由于驱动信号604的调制作用，雾滴702a-n被703a-n表示辐射压以不同速率推出，因此导致现在尺寸不一致。因此，借助施加到驱动信号404、604的调制，雾滴702a-n的运动不一致，使得各个雾滴702a-n相互碰撞和聚结，从而形成较大的雾滴702b和702c，以各自不同的速率703b和703c运动。随着雾滴702a-n尺寸增大，受重力的影响，较大的雾滴702c在重力705的作用下从细雾流700中掉下。
减小辐射力可很大程度上“减少”雾的产生。例如，对于比其他超声器械低70％振幅运行的超声器械来说，辐射压接近于其他超声器械辐射压的一半。较低的辐射压使用一半辐射力将雾滴推出。因此，细雾流的体积将显著减小。由于频率“f”设计为固定的额定频率55.5kHz，并且只在刀片50(例如刀片)升温时略微降低，因此此类系统产生的雾滴502的粒径“d”对于所有端部执行器50(例如刀片)来说都是相等的。
在一个实施例中，通过调制波形606调制驱动信号604，超声换能器驱动模块600修正驱动信号604以减小细雾流500(图5)并且产生细雾流700(图7)。这可包括调制电流驱动信号604以改变驱动信号604的振幅“A”、驱动信号604的频率“f”或它们的任意组合。在一个实施例中，超声换能器驱动模块600改变刀片50的远端52的辐射压，使得与远端52相距不同的雾滴702a-n以不同的相对速率从远端52移出。雾滴702a-n之间的相对运动会增大相互碰撞和聚结的可能性。随着更多的雾滴702a-n聚结，雾滴502的粒径范围不断扩大，形成更多的相互碰撞和更大的雾滴，例如702b和702c。雾滴702c的粒径达到一定程度后，受重力的影响，较大的雾滴702c从细雾流中掉下。
在一个实施例中，超声换能器驱动模块600也可用来改变由刀片50的远端52产生的雾滴702a-n的粒径。因此，在一个实施例中，雾滴702a-n的粒径只取决于调频“fm”(对于给定的液体)而不取决于振幅“A”。因此雾滴502的粒径可根据调频“fm”而变化。考虑到超声外科器械100为高“Q”装置，因此调频“fm”的变化仅有几赫兹。故意地以低占空比、另一共振短暂地驱动系统是可能的。但是该方法可能不实用并且可能导致其他不良影响。然而，该特性可结合到其他实施例中并被视为随附的权利要求范围的一部分。
图8示出具有相位调制功能的超声换能器驱动模块800的一个实施例。采用相位调制驱动信号828驱动换能器14。模块800可为超声信号发生器12的一个实施例的元件。电压测量模块804测量换能器14的电压并且将具有相位
Figure GPA00001011270400171
的电压测量信号808提供到检相器812。电流测量模块806测量通过换能器14的电流并且将具有相位的电流测量信号810提供到检相器812。检相器812确定电压测量信号808和电流测量信号810之间的相位差并且提供与此相位差成比例的相对相位信号814。由于换能器14通常由实际功率驱动，所以相位信号814在零上下小幅变化。相位设定点模块824产生相位调制波形816“Sm”，该波形改变调制驱动信号828的相位，使其在额定设定点(通常为零相位)上下变化。相位调制波形816和相对相位信号814被馈送至加法器模块406的输入端。加法器模块406执行加法功能并且生成与相位调制波形816和相对相位信号814之间的差异成比例的误差信号818。控制器820监控误差信号818并且将频率控制信号830提供到信号生成器822。信号生成器822生成具有额定频率的正弦驱动信号826。频率控制信号830与误差信号818成比例地调整正弦驱动信号826的频率。功率放大器420对正弦驱动信号826进行放大，产生相位调制驱动信号828驱动换能器14。
在数字实施中，模块根据完善的数字信号处理技术，确定各个数字信号之间定时的相对差异，而不是确定各个信号之间的相对相位差。例如，当电压测量模块804和电流测量模块806使用数字模块实施时，可采用合适的数字电路模块取代检相器812，以确定每个信号分量之间的相对时间延迟或时间差。同样地，在数字域中，控制器820调整驱动信号发生器822的时钟和定时，而非产生频率控制信号830。
相位调制波形816
Figure GPA00001011270400173
可表示为：
Figure GPA00001011270400174
相位调制波形816
Figure GPA00001011270400175
包括调制相位分量“φm”和调频分量
Figure GPA00001011270400176
如上所述，由于换能器14通常由实际功率驱动，所以相位调制波形816
Figure GPA00001011270400177
在“0”上下变化，因此，名义上除了相位设定点模块824引起的相位(或者频率)变化，电压测量信号808和电流测量模块810之间不存在相位差。在图8所示的实施例中，功率放大器420对正弦驱动信号826进行放大，产生相位调制波形816相位或频率变化的驱动信号828。这样，缓慢变化的相位分量或频率分量施加到正弦驱动信号828上。在相对较轻的组织负载下，频率变化大约为几赫兹。由于Q较低，在相对较重的组织负载下，频率变化大约为数十赫兹。相位或频率的变化相对较小。根据等式(4)，雾滴的粒径“d”与频率“f”的2/3次方成反比(即)。因此，随着频率“f”增大，雾滴的粒径“d”减小。存在关于上述等式(4)给出的平均尺寸的雾滴粒径的分布。但是该分布比较紧密，所以分布中的雾滴的粒径“d”几乎一致。由于相位或频率变化引入正弦驱动信号826，因此由相位调节驱动信号828驱动的超声刀片50作用于雾滴上，产生如细雾流700(图7)所示的不一致的粒径。粒径不一致有助于雾滴702a-n聚结并且在重力705的作用下从细雾流700中掉下。
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。无论是哪种情况，该装置至少使用一次后经过修理后可再使用。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
Figure GPA00001011270400182
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执行器。此外，可使用所述实施例的组合。例如，端部执行器可适于涂覆有“疏血(hemophobic)”材料的凹型刀片尖端。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 (24)

1.一种外科器械，包括：
换能器，所述换能器能够沿着纵向轴线以预定频率产生振动；
端部执行器，所述端部执行器能够连接到沿着所述纵向轴线延伸的所述换能器，所述端部执行器包括具有近端和远端的主体，所述远端能够通过所述换能器产生的振动相对于所述纵向轴线运动；和
驱动模块，所述驱动模块连接到所述换能器以产生调制驱动信号，其中所述端部执行器的远端能够响应由所述换能器响应所述调制驱动信号所产生的振动而运动。
2.根据权利要求1所述的外科器械，其中所述驱动模块包括：
调制器，所述调制器包括用于接收电流设定点信号的第一输入端和接收调制波形的第二输入端，所述调制器产生调制信号；和
电流控制回路，所述电流控制回路耦合到所述调制器以接收所述调制信号以及控制耦合到所述换能器的所述调制驱动信号。
3.根据权利要求2所述的外科器械，其中所述调制波形为时变信号，
所述时变信号包括：
调幅(Am)分量和调频(fm)分量；其中所述调制波形由以下关系限定：
Sm＝1+Am·sin(2π·fm·t)
4.根据权利要求3所述的外科器械，其中所述调制波形包括时变调幅(Am)分量。
5.根据权利要求3所述的外科器械，其中所述调制波形包括时变调频(fm)分量。
6.根据权利要求3所述的外科器械，其中所述调制波形包括时变调幅(Am)分量和时变调频(fm)分量。
7.根据权利要求1所述的外科器械，其中响应于所述调制驱动信号，
所述端部执行器的所述远端能够将与所述调制驱动信号成比例的辐射压力施加到与所述端部执行器的所述远端接触的液滴上。
8.根据权利要求1所述的外科器械，其中所述驱动模块包括：
加法器，所述加法器包括接收相对相位信号的第一输入端和接收相位调制波形的第二输入端，所述加法器用于产生相位调制信号，其中所述调制波形为相变信号，所述相变信号包括：
相位调制(φm)分量和调频
Figure FPA00001011270300021
分量；其中所述调制波形由以下关系限定：
Figure FPA00001011270300022
9.一种方法，包括：
获得权利要求1所述的外科器械；
对所述外科器械进行消毒；以及
将所述外科器械储存在消毒容器中。
10.一种超声信号发生器，包括：
驱动模块，所述驱动模块用于产生调制驱动信号以耦合到换能器，
其中所述换能器连接到具有远端的端部执行器，所述远端能够响应由所述换能器响应所述调制驱动信号所产生的振动而运动。
11.根据权利要求10所述的超声信号发生器，其中所述驱动模块包括：
调制器，所述调制器包括用于接收电流设定点信号的第一输入端和接收调制波形的第二输入端，所述调制器用于产生调制信号；和
电流控制回路，所述电流控制回路耦合到所述调制器以接收所述调制信号以及控制耦合到所述换能器的所述调制驱动信号。
12.根据权利要求11所述的超声信号发生器，其中所述调制波形为时变信号，所述时变信号包括：
调幅(Am)分量和调频(fm)分量；其中所述调制波形由以下关系限定：
Sm＝1+Am·sin(2π·fm·t)
13.根据权利要求12所述的超声信号发生器，其中所述调制波形包括时变调幅(Am)分量。
14.根据权利要求12所述的超声信号发生器，其中所述调制波形包括时变调频(fm)分量。
15.根据权利要求12所述的超声信号发生器，其中所述调制波形包括时变调幅(Am)分量和时变调频(fm)分量。
16.根据权利要求10所述的超声信号发生器，其中响应于所述调制驱动信号，所述端部执行器的所述远端能够将与所述调制驱动信号成比例的辐射压力施加到与所述端部执行器的所述远端接触的液滴上。
17.根据权利要求10所述的超声信号发生器，其中所述驱动模块包括：
加法器，所述加法器包括接收相对相位信号的第一输入端和接收相位调制波形的第二输入端，所述加法器用于产生相位调制信号，其中所述调制波形为相变信号，包括：
相位调制(φm)分量和调频
Figure FPA00001011270300031
分量；其中所述调制波形由以下关系限定：
18.一种方法，包括：
采用驱动模块产生调制驱动信号；以及
将所述调制驱动信号耦合到换能器，其中所述换能器连接到具有远端的端部执行器；
其中所述远端能够响应由所述换能器响应调制驱动信号所产生的振动而运动。
19.根据权利要求18所述的方法，包括：
在调制器的第一输入端处接收电流设定点信号；
在所述调制器的第二输入端处接收调制波形；
通过采用所述调制波形调制所述电流设定点信号来产生调制信号；
以及
将所述调制信号与电流控制回路耦合以控制耦合到所述换能器的所述调制驱动信号。
20.根据权利要求19所述的方法，包括：
接收包括调幅(Am)分量和调频(fm)分量的调制波形；其中所述调制波形由以下关系限定：
Sm＝1+Am·sin(2π·fm·t)
21.根据权利要求19所述的方法，包括：
接收包括时变调幅(Am)分量的调制波形。
22.根据权利要求19所述的方法，包括：
接收包括时变调频(fm)分量的调制波形。
23.根据权利要求19所述的方法，包括：
接收包括时变调幅(Am)分量和时变调频(fm)分量的调制波形。
24.根据权利要求18所述的方法，包括：
响应所述调制驱动信号，将与所述调制驱动信号成比例的辐射压力施加到与所述端部执行器的所述远端接触的液滴上。
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CN105992563A (zh) * 2013-12-16 2016-10-05 伊西康内外科有限责任公司 医疗装置
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CN108366805A (zh) * 2015-12-21 2018-08-03 伊西康有限责任公司 具有管状声波导片段的超声外科器械
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US20090036911A1 (en) 2009-02-05
JP5687058B2 (ja) 2015-03-18
CN101772326B (zh) 2012-11-14
WO2009032439A1 (en) 2009-03-12
US20120323265A1 (en) 2012-12-20
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CA2694954A1 (en) 2009-03-12
EP2190362A1 (en) 2010-06-02

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