CN1826084A - 手致动的超声器械 - Google Patents
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- A61B17/32—Surgical cutting instruments
- A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
- A61B17/320092—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw
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- A61B17/32—Surgical cutting instruments
- A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
- A61B17/320092—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw
- A61B2017/320094—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw additional movable means performing clamping operation
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
- A61B17/320092—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw
- A61B2017/320095—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw with sealing or cauterizing means
Abstract
一种超声外科夹钳凝结器设备(120)被构造成通过将设备的夹钳机构与相关联的超声端部执行器协作来实现组织的切割、凝结和夹钳。设备的手柄被构造成允许在外科手术期间手致动组织的切割、凝结和夹钳。为了更加方便和有效地使用该设备,将指尖控制(36a),(36b)在允许外科医生在不重新定位他们的手的情况下致动设备的位置直接提供到处理剪切器手柄。两个按钮提供了对可由发生器实现的两个能量级别的独立控制,与现有技术中的两个脚踏板构造相匹配。
Description
相关申请的参考
本申请要求2003年6月17日提交的申请序列号为60/478,984的美国临时专利申请的优先权,在此将该美国申请引入作为参考。
本申请包含与共有专利申请No.09/879,319和No.09/693,549相关的主题,在此将这两个申请引入作为参考。
技术领域
本发明总的涉及超声外科装置,更具体地说,涉及一种用于凝结和/或切割组织的超声外科夹钳凝结器设备,其包括为方便医生接触而定位于手柄上的手致动开关。
背景技术
超声外科器械由于其独特的性能特点正愈加广泛地应用于外科手术中。根据具体的器械构造和工作参数,超声外科器械能够基本上同时实现组织切割和通过凝结止血,从而理想地最小化病人的创伤。切割动作通常由器械远端的端部执行器通过将超声能量传送到其所接触的组织来实现。这种性能的超声器械可被构造成用于开放外科手术,或者腹腔镜或内窥镜外科手术。
超声外科器械已经被研制成包括夹钳机构,以将组织压靠于器械的端部执行器(即,切割刀片)上,以便将超声能量传送到病人的组织上。在美国专利No.5,322,055;5,873,873和6,325,811中公开了这种布置(有时称为夹钳凝结剪切器或超声处理装置),这些专利在此引入作为参考。外科医生致动夹钳垫板以通过挤压在把手或手柄上来压靠在端部执行器上。
在对手柄施加压力以将组织压在夹钳垫板和端部执行器之间的同时由医生操作的脚踏板致动发生器,该发生器提供传送到切割刀片的能量,用于切割和凝结组织。这种器械致动的主要缺点包括在医生找寻脚踏板的同时失去了对手术区域的集中,在手术过程中脚踏板妨碍了医生的移动,并且在长时间手术时使医生的腿疲劳。
本发明克服了现有技术的缺点并且针对一种改进的超声外科夹钳凝结器剪切设备,该设备提供了更具有人机工程学性质的手段,用于通过在手柄上结合指尖控制致动剪切器。
发明内容
一种体现本发明的原理的超声外科夹钳凝结器设备被构造成允许在外科手术期间手致动组织的切割、凝结和夹持。为了更加方便和有效地使用该设备,将指尖控制在允许外科医生在不重新定位他们的手的情况下致动装置的位置直接提供到处理(disposal)剪切器手柄。两个按钮提供了对可由发生器实现的两个能量级别的独立控制,对应两个脚踏板的构造。
在一个实施例中,按钮为摇臂式结构,其中按钮独立于使用者而出现,但其实际上是围绕中心轴线旋转的独立单元。这种结构消除了对按钮的双重致动,其将导致发生器的错误状态。按钮也以一种方式被结合,在该方式中按压/致动的角不平行,而是朝向空间中的公共点形成角度以改善人机工程学感觉。另外,将按钮分隔开以允许使用者将他们的触发器手指(例如,食指)放在按钮之间。这种结构最小化了无意识操作的可能性并在抓握和操纵组织期间提供了高度抓握稳定性。将在弯曲电路(flex circuit)内一体地结合的圆顶开关与摇臂开关结合,以提供电接触和摇臂开关的咬合感觉(snapfeel)。
本发明还为手持件提供了一体的电连接。一旦手持件牢固地安装到一次性剪切装置上,滑动接触就在剪切器和手持件之间提供所需的电连接。在一个实施例中,电连接仅需要用于控制两个能量级别的两根导线。
根据所示的实施例,本超声外科夹钳设备包括优选包括把手部分的壳体。该设备还包括细长部分(其可以被构造用于内窥镜应用)、可定位在实现组织切割、凝结和/或夹钳的区域的远端。在该优选实施例中,两个开关安装在手枪式握把上,用于实现发生器的致动,以将超声能量提供给端部执行器。
本设备包括用于抵靠超声端部执行器夹钳组织的夹钳机构。该夹钳机构包括可枢转地安装在外部管状护套的远端的夹钳臂以相对于端部执行器枢转。组织被夹钳在夹钳臂和端部执行器之间,由此将组织与端部执行器超声地连接(当供电时)或者允许当超声能量没有通过波导管传送到端部执行器时抓握或夹钳组织。夹钳臂可操作地连接到设备的往复致动构件上,从而致动构件的往复运动使夹钳臂相对于端部执行器枢转运动。
枢转连接到设备壳体上的操作杆提供对设备夹钳机构的选择性操作。在优选实施例中,操作杆和相关联的壳体把手部分设有手枪状构造,从而允许由使用者的拇指方便地移动操作杆。操作杆通过夹钳驱动机构与往复致动构件互相连接,从而操作杆的枢转运动致动构件往复运动,用于使设备的夹钳臂枢转运动。值得注意的是,把手部分包括用于致动端部执行器的两个按钮,从而允许医生的指尖选择性地致动端部执行器。
通过下面的详细说明、附图以及后附的权利要求书,将更容易理解本发明的进一步特征和优点。
附图说明
图1是包括体现本发明的原理的超声夹钳凝结器设备的超声外科手术系统的透视图;
图2是图1的夹钳凝结器设备的夹钳机构的放大的局部正视透视图;
图3是体现本发明原理的夹钳凝结器的部分切除的侧视图;
图4是本发明的夹钳凝结器的装配图;
图5是结合摇臂开关、手持件连接器、两个滑环以及弯曲电路的手柄的分解图;
图6a-b分别是大滑环和小滑环的分解图;
图7是手持件连接器的分解图;
图8a-b分别是弯曲电路设备的分解图和相关电路示意图;
图9是示例了开关的空间布置的本发明的超声器械的手柄的示意图;以及
图10是开关组件的分解图。
具体实施方式
在具体阐述本发明之前,应当注意本发明的应用或使用不限于附图和说明书中示例的部件的具体结构和布置。本发明的示例性实施例可以以其它实施例、变型和修改实施或结合,并且可以以各种方式执行或实现。此外,除非另外指出,在此使用的术语和措辞仅为了便于读者理解本发明的示例性实施例,而并非限制本发明。
本发明具体地涉及一种改进的超声外科夹钳凝结器设备,其被构造成在手术期间实现组织切割、凝结和/或夹持。本设备能够容易地被配置用于开放外科手术过程以及腹腔镜或内窥镜手术。通过选择性地使用超声能量,可用于各种用途。当手术的超声部件不工作时,可以根据需要容易地抓握和操纵组织而不会产生组织切割或损伤。当超声部件工作时,设备允许组织被抓握用于与超声能量联接,以实现组织凝结,通过施加增加的压力有效地实现组织切割和凝结。如果需要,可通过适当操作装置的超声“刀片”或端部执行器将超声能量施加到组织上而不使用设备的夹钳机构。
如将通过下面的说明书更清楚地描述的那样,本夹钳凝结器设备由于其简单(straightward)构造特别地构造成适于一次性使用。同样,可以构想该设备可与外科手术系统的超声驱动单元联用,由此,来自驱动单元的超声能量提供本夹钳凝结器设备所需的超声致动。应当理解,体现本发明的原理的夹钳凝结器设备可以被构造成非一次性使用,并且可与相连的超声驱动单元不可分离地形成一体。然而,本夹钳凝结器设备与相关超声驱动单元的可分离的连接目前优选为单个病人使用该设备。
参照图1和3,其中示例了通常以附图标记10表示的本发明外科手术系统的优选实施例,该系统包括体现本发明原理的超声夹钳凝结器设备。将首先描述外科手术系统10的超声发生器和相关超声驱动单元的优选细节,然后详细描述体现本发明原理的端部执行器的指尖致动。
外科手术系统10包括超声发生器30和相关的超声外科器械。该外科器械包括以附图标记50表示的超声驱动单元和体现本发明原理的超声夹钳凝结器设备120。如将进一步描述的那样,驱动单元50的超声换能器和夹钳凝结器120的超声波导管共同提供了本外科手术系统的声学组件,当由发生器30供电时,声学组件为外科手术提供超声能量。应当注意,在一些应用中,超声驱动单元50被称为“手持件组件”,这是因为外科手术系统的外科器械被构造成在各种手术和操作期间,医生抓握和操纵超声驱动单元50。体现本发明原理的夹钳凝结器设备120优选包括手枪状抓握装置,该装置除操纵超声驱动单元50外还便于定位和操纵器械。
例如可从俄亥俄州辛辛那提市的Ethicon EndoSurgery公司商业购买的发生器300的外科手术系统的发生器30通过电缆32以由发生器30的控制系统确定的经选择的电流、频率和相位发送电信号。如同将进一步描述的那样,该信号使外科器械的声学组件的一个或多个压电元件膨胀或收缩,由此将电能转换为机械运动。机械运动导致了超声能量的纵波,其通过声学组件以声学驻波的形式传播,以便以经选择的频率和振幅振动声学组件。位于声学组件的波导管的远端的端部执行器接触病人组织而放置,以将超声能量传送到组织。如将进一步描述的那样,诸如夹爪或夹钳机构的外科工具优选用于将组织压靠在端部执行器上。
由于端部执行器与组织联接,由组织内的摩擦、声学吸收和粘滞损失产生热能或热量。热量足以破坏蛋白质氢键,从而使高度组织化的蛋白质(即,胶原和肌肉蛋白)变性(即,使组织化程度减少)。由于蛋白质变性,粘性凝结物形成,以密封或凝结小血管。当这种效果延长时,导致较大血管的深度凝结。
将超声能量传递到组织产生包括机械撕裂、切割、气蚀、细胞破碎和乳化的其它效果。所获得的切割量和凝结程度随端部执行器的振幅、振动频率、使用者施加的压力大小、端部执行器的锐度以及端部执行器和组织之间的联接而变化。
如图1和3所示,发生器30包括与发生器30成一整体的控制系统和开关34。电源开关34控制发送到发生器30的电力,并且当由触发机构36a-b致动时,发生器30提供能量驱动外科手术系统10的声学组件40,以便以预定的振幅水平驱动端部执行器。发生器30以声学组件的任何合适的谐振频率驱动或激励声学组件。
当发生器30通过触发机构36a-b致动时,发生器30连续地对换能器组90施加电能。发生器30的控制系统中的锁相环路监控从声学组件的反馈。锁相环路调节由发生器30发送的电能的频率,以匹配包括组织负载的声学组件的振动的所选纵向模式的谐振频率。另外,控制系统中的第二反馈回路将供给声学组件的电流保持在预选择的恒定级别,以便在声学组件的端部执行器处实现基本上恒定的振幅。
供给声学组件的电信号将使波导管的远端,即端部执行器(图2)在例如大约20kHz-250kHz的范围、优选在大约54kHz-56kHz的范围、最优选大约55.5kHz纵向地振动。在端部执行器处的振动的幅度可以例如通过控制由发生器30供给换能器组件40的电信号的振幅来控制。开关36a提供一个级别的振幅,开关36b提供第二级别的振幅。
如上所述,发生器30的触发机构36a-b允许使用者致动发生器30,从而可以连续地将电能供给声学组件。触发机构36a-b优选包括摇臂开关,该摇臂开关定位于手柄224上并且通过电缆或绳索电联接或固定在发生器30上。可选择地,触发机构36a-b可以位于其它方便的位置,例如拇指环222上或护罩130上。
参照图1、3和4,手持件50包括适于将操作者与声学组件的振动隔离的多件壳体52。驱动单元壳体52具有可由使用者以常规的方式握持的形状,但是可以预见,如将要描述的那样,本夹钳凝结器120主要通过由设备的壳体提供的手枪状布置来抓握和操纵。虽然示例了多件式壳体52,但是壳体52可以包括单独的或单一式的组成元件。
壳体52总的包括近端、远端和在其中纵向延伸的腔。壳体52的远端包括开口60,其被构造成允许外科手术系统10的声学组件穿过其而延伸,壳体52的近端由电缆32连接到发生器30上。
壳体52优选由铝制成,然而也可以预想,壳体52可以由各种塑料(例如Ultem RTM)制成。合适的超声驱动单元50的型号是no.HP054,可从俄亥俄州辛辛那提市的Ethicon EndoSurgery公司购买。两镀金的环形电连接器111a和111b位于驱动单元50的远端,用于将电控制信号从开关36a-b连通到发生器30。
如图3和5所示,手持件50优选声学地联接到超声夹钳凝结器设备120的第二声学部分。驱动单元50的远端优选通过波腹(anti-node)附近的内螺纹连接件联接到第二声学部分的近端上,但是可以采用可选择的联接布置。如下更详细地描述的那样,当驱动单元50插入壳体130并连接到其上时,驱动单元50的远端穿过连接器300,并且环状连接器111a-b分别与滑环连接器310和320界面连接。
现在还参照图4,示出了根据优选实施例的外科手术系统10的超声夹钳凝结器设备120的分解图。如图3所示,通过将驱动单元插入设备的壳体内,超声夹钳凝结器设备120的近端优选收纳并被装配到超声驱动单元50的远端上。超声夹钳凝结器设备120优选作为一整体连接到超声驱动单元50上和从其上去除。在一次使用后超声夹钳凝结器120可以被去除。
超声夹钳凝结器设备120优选地包括手柄组件或壳体130,其优选包括配套的壳体部分131,132以及细长的或内窥镜部分150。当本设备构造用于内窥镜使用时,该结构可以具有这样的尺寸,即,使部分150的外径大约为5.5mm。超声夹钳凝结器设备120的细长部分150从设备壳体130垂直地延伸。细长部分150可以相对于壳体130选择性地旋转。细长部分150优选包括外部管状构件或护套160、内部管状致动构件170和以具有端部执行器180’的波导管180的形式存在的声学系统的第二声学部分。外部管160、内部管170、端部执行器180’和夹钳板190都可操作地与旋钮216相联,从而旋钮216的旋转导致端部执行器180’和夹钳臂190的相应旋转。
如图4所示,第二声学部分的波导管180的近端优选可拆卸地连接到上述波膜附近的超声驱动单元50的安装装置84上。波导管180优选具有基本上等于二分之一系统波长的整数的长度。波导管180优选由实心轴制成,该实心轴由有效传播超声能量的材料构成,例如钛合金(即,Ti-6Al-4V)或铝合金。可以预想,波导管180可选择地由其它适合的材料制成。
特别参照图2,本夹钳凝结器120的夹钳机构被构造成与波导管180的端部执行器180’相配合作用。夹钳机构包括可枢转运动的夹钳臂190,该夹钳臂在其远端枢转地连接到外部管状护套160的远端上。优选由聚四氟乙烯或其它合适的低摩擦材料制成的夹钳板192安装在夹钳臂的表面上,用于与端部执行器180’协作,夹钳臂的枢转运动将夹钳板定位成与端部执行器180’基本上平行且接触的关系。通过这种结构,组织被抓握在夹钳板192和端部执行器180’之间。如所示出的,夹钳板192优选设有锯齿状构造,以提高与端部执行器180’协作抓握组织的能力。如本领域普通技术人员所理解的那样,端部执行器180’和夹钳板190可以采取许多种形状,包括美国专利No.6,325,811中公开的弯曲形。
如前面引入作为参考的美国专利所描述的,医生的拇指挤压触发器222,以使夹钳机构将可动夹钳臂190枢转。医生的其它一个或多个手指可以舒适地靠在手柄224内。根据本发明,医生的食指通过选择地按压开关36a-b控制发生器30的工作。开关36a-b被方便地如此定位,即,使得医生可以激励端部执行器180’,并且通过旋钮216使用相同的手(手指)操作使端部执行器180’和夹钳板190旋转。
现在参照图5-8和10,开关36a-b通过摇臂40机械地连接,该摇臂包括用于收纳枢轴柱42的孔140a。在这种构造中,不能同时按压开关36a-b,如果同时按压,将从发生器30提供错误信息。弯曲电路330通过驱动单元50提供在开关36a-b和发生器30之间的机电界面。同样参照图8,弯曲电路330在其远端包括两个圆顶开关332和334,这两个开关分别通过按压相应的开关36a-b的销142a-b机械地致动。圆顶开关332和334是电接触开关,该开关在被按压时将电信号提供到发生器30,如图8b的布线示意图所示。同样如图8b所示,弯曲电路330还包括在二极管封装内的两个二极管。如本领域技术人员已知的,弯曲电路330提供导体,其通过连接器300连接到滑环导体310和320上,而这又对环状导体111a-b提供电接触,该环状导体又连接到连接发生器30的电缆32中的导体上。如美国专利No.6,623,500B1(该专利的内容在此引用作为参考)中基本描述的,环状导体111a-b位于手持件50的远端内。
现在特别参照图6a-b和7,滑环导体310和320通常是端部开口的O形弹簧,其分别在连接器300的安装表面302和304上滑动。各弹簧片滑环包括两个压力点接触件(312a-b和322a-b),其分别接触手持件50的环状导体111a-b。滑环310和320的弹簧张力导致在接触件312a-b、322a-b和导体111a-b之间正电接触(positivecontact)。显然,即使在使用器械期间手持件50可以由医生旋转时,滑环结构允许形成电接触。滑环的柱314和324分别电连接到弯曲电路330内的各导体上,以实现如图8b所示的电路。
现在参照图9,开关36a-b以给医生提供人机工程学上满意的抓握和操作的方式优选地构成。特别是,按压/致动开关36a-b的角度不平行,但是在触发器222处于其正常状态时,每个开关的致动方向限定了相对于在拇指抓握触发器222的拇指放置区域内的公共点P的致动角θ1。角θ1优选为在大约10°到大约30°范围内,更优选在大约15°到大约20°的范围内。开关36a-b也由距离L1隔开,该距离足够使靠在手柄224上的开关36a-6之间的医生手指的无意识的动作最小化,但是同时在组织抓握和操纵功能期间提供高度的抓握稳定性。距离L1为大约1英寸到大约0.5英寸,更优选为大约0.8英寸到大约0.6英寸。
虽然已经通过对几个实施例的描述示例了本发明,但申请人不意味着将后附权利要求的精神和范围限定为这些具体内容。在不背离本发明范围的情况下,本领于普通技术人员能够进行各种变型、改变和替换。而且,可以选择性地将与本发明有关的各元件的结构描述为用于提供由该元件所执行的功能的手段。因此,这意味着本发明由后附权利要求的精神和范围限定。
Claims (5)
1.一种超声外科器械,其包括:
a)壳体,用于收纳提供超声能量的手持件,该壳体包括;
b)手柄,其具有与器械的使用者相接触的构造;以及
c)至少一个开关,其位于手柄上并与发生器电连接,用于给发生器提供电信号,以控制由手持件传递的超声能量的水平。
2.根据权利要求1所述的超声外科器械,其特征在于,所述手柄包括两个开关:第一开关,其被电连接到发生器上,用于将第一电信号提供给发生器;第二开关,其被电连接到发生器上,用于将第二电信号提供给发生器。
3.根据权利要求1所述的超声外科器械,其特征在于,所述手持件包括用于从开关接收电信号的电导体。
4.根据权利要求2所述的超声外科器械,其特征在于,所述两个开关由大约二分之一英寸到大约一英寸的距离分隔开。
5.根据权利要求2所述的超声外科器械,其特征在于,所述第一和第二开关各限定了一条致动线,所述致动线形成大约10°到大约30°的致动角。
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- 2004-06-16 JP JP2006517341A patent/JP5089980B2/ja active Active
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AU2004249219A1 (en) | 2004-12-29 |
US20140180175A1 (en) | 2014-06-26 |
JP5583637B2 (ja) | 2014-09-03 |
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EP1635718A4 (en) | 2008-03-26 |
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AU2011200341A1 (en) | 2011-02-17 |
CN100522084C (zh) | 2009-08-05 |
JP5089980B2 (ja) | 2012-12-05 |
EP2366345A1 (en) | 2011-09-21 |
US20130165929A1 (en) | 2013-06-27 |
US20110004233A1 (en) | 2011-01-06 |
EP2298197A2 (en) | 2011-03-23 |
EP1635718A2 (en) | 2006-03-22 |
EP2298197A3 (en) | 2011-06-08 |
CA2529740A1 (en) | 2004-12-29 |
EP1635718B1 (en) | 2021-02-24 |
JP2007523673A (ja) | 2007-08-23 |
AU2011200342A1 (en) | 2011-02-17 |
PL2366345T3 (pl) | 2021-12-06 |
PL2298197T3 (pl) | 2022-02-07 |
US20120172904A1 (en) | 2012-07-05 |
US20050033337A1 (en) | 2005-02-10 |
JP2011189177A (ja) | 2011-09-29 |
EP2298197B1 (en) | 2021-01-27 |
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