CN101035482B - 超声外科器械 - Google Patents
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Abstract
一种超声夹钳凝结器组件(100),其被构造为在外科手术过程中允许选择性地进行组织的切割、凝结和夹钳。该器械的细长部分可以被构造用于内窥镜应用并且外径小于6mm。该构造包括夹钳机构,夹钳机构包括可枢转地连接在器械远侧部分处的夹钳臂,夹钳臂被特别构造为产生所需水平的组织夹钳力,当扳机完全闭合时该力超过4磅。夹钳机构包括两件式垫的结构、能够实现较高的组织夹钳力的垫材料和有效地消除误用组织力的力限制机构。该组件的特征还在于手致动,其被构造为为医生提供人体工程学的握持和操作。无论用左手还是右手来握持外科器械,手动开关都位于医生拇指的自然摆动范围内。
Description
相关申请的引用
本申请要求2004年10月8日提交的序列号为60/617,427和2005年5月2日提交的序列号为60/676,709的美国临时专利申请的优先权,它们的内容通过参考结合入本申请中。
本申请包括涉及以下非临时申请的主题,为了任何以及全部的目的,它们的内容通过参考结合入本申请中:
2005年10月7日提交的COMBINATION TISSUE PAD FOR USEWITH AN ULTRASONIC SURGICAL INSTRUMENT,序列号待授;
2005年10月7日提交的ACTUATION MECHANISM FOR USE WITHAN ULTRASONIC SURGICAL INSTRUMENT,序列号待授;
2005年10月7日提交的CLAMP MECHAMISM FOR USE WITH ANULTRASONIC SURGICAL INSTRUMENT,序列号待授;
2005年10月7日提交的FEEDBACK MECHAMISM FOR USE WITHAN ULTRASONIC SURGICAL INSTRUMENT,序列号待授;
2005年10月7日提交的HANDLE ASSEMBLY HAVING HANDACTIVATION FOR USE WITH AN ULTRASONIC SURGICALINSTRUMENT,序列号待授;
2005年2月24日提交的ULTRASONIC SURGICAL SHEARS ANDTISSUE PAD FOR SAME,序列号为11/065,378;以及
2004年6月16日提交的HAND ACTICATED ULTRASONICINSTRUMENT,序列号为10/869,351。
技术领域
本发明总的涉及超声外科器械,更具体而言,涉及具体被构造为提供增大的组织横切力的超声外科夹钳凝结器装置。
背景技术
由于超声外科器械的独特性能,这种器械在外科手术中得到了越来越广泛的应用。根据具体的器械构造和操作参数,超声外科器械可以基本上同时提供组织的切割和通过凝结止血,从而使对患者的损伤最小。切割动作通常是通过位于器械远端处的端部执行器来实现的,端部执行器向与其接触的组织传递超声能量。这种特性的超声器械可以被构造成用于开放式外科应用、腹腔镜或内窥镜外科手术(包括机器人辅助的手术)。
已经开发了包括夹钳机构的超声外科器械,夹钳机构用于将组织压靠端部执行器的刀,以将超声能量传到患者的组织。这样的设置(有时称作夹钳凝结器剪刀或超声横切器(transector))公开在美国专利No.5,322,055、5,873,873和6,325,811中,所有这些都通过引用结合入本文。医生通过挤压手柄或者把手来致动夹钳臂,以使夹钳垫压靠刀。
但是,一些当前的超声剪刀装置易于产生组织残留物(tissue tag)。组织残留物是在钳口中的大部分组织已经被横切并且离开之后留下的还没有被横切的留在钳口中的组织。组织残留物可以是由于端部执行器的近侧加载不足和/或下部近侧刀的动作不够造成的。通过在装置上施加附加的竖直张力(也就是使用刀将张力作用在组织上)或者向后的拉力以将未被横切的组织移动至刀的更有效的部分来完成切割,医生可以减少这种组织残留物。
一些目前的超声剪刀装置使用与刀表面平行地闭合的组织垫。这出现了与施加在组织上的压力分布相关的问题。由于组织被压在钳口和刀之间,刀的近侧部分在压力下的偏移大于夹钳臂的近侧部在向刀施加负载时分移动的程度。这种偏移的产生部分是由于刀的一部分位于比装置的最远侧节点更远的位置。这种偏移还部分是由于靠近最远侧节点的传输杆的偏移所引起的。此外,随着靠近刀的尖端,刀的振幅减小,这样的事实使得情况更糟,因为即使压力恒定,传输至组织的能量的量减少了。
目前的组织垫设计使用PTFE材料来接触组织和刀。尽管这些设计已 经足够,但是它们容易具有寿命不长的问题,因为这些垫容易在长期的外科手术中损坏。此外,夹钳凝结器剪刀的较新设计增加了刀振幅和/或垫向组织和刀的载荷,并由此破坏垫材料,不需要要求组织垫的寿命。垫材料限制了可以向组织和刀施加的力的大小,这样又限制了一些目前的夹钳凝结器剪刀可以有效地切割并使其凝结的组织厚度或血管尺寸。
夹钳凝结器剪刀的目前的一些设计使用位于外管中的内管的构思,以便驱动夹钳臂打开和闭合。在外科手术中,夹钳臂可能经受超过2.5磅的轴向夹钳力和/或不当的扭转载荷,并可能引起夹钳臂与内管脱离或者完全与剪刀脱离。
夹钳凝结器剪刀的目前的一些设计使用恒力弹簧机构,其防止施加过大的力至夹钳臂和刀。尽管该机构为系统提供了相对恒定的力,但是弹簧使力曲线有些倾斜。在夹钳力较低的应用中,倾斜不显著。但是,在夹钳力较大的应用中,在弹簧压缩的可能范围内的对斜率有影响的力的差异变得非常显著并且可能超过刀、管组件或系统其他部件中可允许的最大的力。高的斜率可能在误用模式下或者通过正常的制造公差变化超过最大的力。如果发生了这种情况,则刀可能弯曲,致动机构可能失效或者可能发生不期望的组织效果(也就是快速切割,但是只有最少的组织凝结)。这种情况被以下事实加重,即当钳口几乎接触刀时(当横切薄的组织或者在横切结束时或者夹钳诸如其他装置的固体物体时)或者当钳口仍然打开时(当横切厚的组织时),装置的钳口(夹钳臂和垫)接合力限制机构能遇到很大的阻力。
夹钳凝结器剪刀的目前的一些设计使用限力弹簧来确保夹钳力在指定的范围内。对于限力弹簧的设计,还需要允许医生“以逐渐增大的方式施加力”(施加比最大的力小的力并缓慢地增加至最大的力)。因此,在这些机构中,直到达到预定的力钳口才闭合并且附加的行程将机构驱动到力限制范围中。但是在一些情况下,医生可能无意中没有向组织施加钳口的所有力,导致不完全的组织切割或者不充分的凝结。或者,在横切过程中医生可能无意中释放了钳口施加给组织的所有力,导致不完全的组织切割或者不充分的凝结。
夹钳凝结器剪刀目前的一些设计使用脚踏板来为外科器械供给能量。医生操作脚踏板同时施加压力至手柄,以将组织压在钳口和刀之间,从而致动提供能量的发生器,该能量传递至切割刀以切割并使组织凝结。这种类型的器械启动最主要的缺陷包括没有将注意力集中在手术部位,而是使医生寻找脚踏板,该脚踏板在手术过程中妨碍了医生的运动并且在长时间的操作中医生的腿部容易疲劳。
夹钳凝结器剪刀目前的一些设计已经不需要脚踏板而是提供了对固定扳机的手动启动。这可能不方便,特别是对于具有大手的医生来说。
夹钳凝结器目前的一些设计使用手柄,该手柄可以是手枪把手或剪刀把手设计。剪刀把手的设计可以具有不可移动并固定至外壳的一个拇指或手指把手以及一个可移动的拇指或手指把手。对于使用其他类型外科器械(例如止血钳)的医生来说,这种类型的把手可能不是特别熟悉,因为在诸如止血钳之类的器械中,拇指和手指把手可以彼此相对移动。
因此需要提供一种克服了当前器械的一些缺陷的超声外科器械。这里描述的超声外科器械克服了这些缺陷。
发明内容
体现本发明原理的超声夹钳凝结器组件被构造为在外科手术过程中选择性地允许进行组织的切割、凝结和夹钳。该器械的细长部分可以被构造或用于内窥镜应用并且其外径小于6mm。该构造包括夹钳机构,夹钳机构包括可枢转地连接在器械远侧部分处的夹钳臂,夹钳臂被特别构造为产生所需水平的组织夹钳力,当扳机完全闭合时,该力超过4磅,但是细长部分的横截面相对较小。
所述夹钳机构还包括垫结构和垫的材料,垫材料能够实现较高的组织夹钳力。
所述夹钳凝结器装置还包括力限制机构,其有效地消除误用的组织力。
所述夹钳凝结器装置的特征还在于手致动,其被构造为为医生提供人体工程学的握持和操作。无论用左手还是右手来握持外科器械,手动 开关都位于医生拇指的自然摆动范围内。
附图说明
在所附权利要求书中具体提出本发明的新颖特征。但是,通过结合附图参考以下的描述,可以最好地理解发明本身操作的模式和方法其中:
图1的透视图图示了根据本发明的超声外科器械的一种实施方式;
图2是根据本发明的超声外科器械的实施方式的立体装配图;
图3a是夹钳臂和组织垫的立体装配图;
图3b是夹钳臂和“T”槽的主剖视图;
图3c是夹钳臂和燕尾槽的主剖视图;
图3d是对准并位于夹钳臂中的组织垫的透视图;
图3e是夹钳臂的主视图,图示了锥形的轮廓;
图3f是夹钳臂的俯视平面图;
图4a是刀、夹钳臂、组织垫以及带有处于闭合位置的夹钳臂的致动器管的立体装配图;
图4b是刀、夹钳臂、组织垫以及带有处于打开位置的夹钳臂的致动器管的立体装配图;
图4c是根据本发明的夹钳臂的示意图,图示了力的计算;
图5是根据本发明实施方式的超声外科器械的外壳部分的主剖视图并且是传输杆与端部执行器的局部主剖视图,图示了力限制弹簧和夹钳闭合制动机构;
图6a是外壳的分解图,图示了拇指致动按钮、开关组件和手指握持夹钳致动器的连接装置;
图6b是外壳的分解图,其中为了清晰起见移除了开关组件;
图7是开关组件和电气环导体的立体装配图;
图8a是开关组件和电气环导体的立体装配图;
图8b是换能器的近端的透视图,图示了导体环;
图8c是按钮电路的电气示意图;
图9是超声外科器械的透视图,其中的外壳被剖开并且该器械连接到换能器;
图10是超声外科器械的透视图,其中扳机向远侧延伸并且夹钳臂处于打开位置;
图11是超声外科器械的透视图,其中扳机向近侧缩回并且夹钳臂处于闭合位置;
图12是根据本发明用左手来握持超声外科器械的实施方式的主视图;
图13是根据本发明实施方式用左手来握持超声外科器械的主视图,其中食指操作旋转轮;
图14是根据本发明用左手来握持超声外科器械的主视图,其中拇指操作第一致动按钮;
图15是根据本发明用左手来握持超声外科器械的主视图,其中拇指操作第二致动按钮;
图16a-c的力曲线图示了作为扳机位置和组织状况的函数的各个力;
图17是外科器械的主视图,图示了医生的手指的放置;
图18是根据本发明的超声外科器械的第二实施方式的立体装配图;
图19是手持连接器的分解图;
图20a-b分别是大滑环和小滑环的分解图;
图21是弯曲电路装置的分解图;
图22是图21的弯曲电路的电气示意图;
图23是根据本发明一个方面的外科器械的主视图;以及
图24是根据本发明的一个可选方面的外科器械的透视图。
具体实施方式
在详细说明本发明之前,应当注意,本发明不限于附图和描述中所示部件的详细构造和布置。可以其它实施方式,变形和修改实现本发明的示例性实施方式,或者本发明的示例性实施方式可以包含在其他实施 方式、变化和修改中,并可以以各种方式来实践或者执行。此外,除非以别的方式说明,这里使用的术语和形式的选择是为了描述本发明的示例性实施方式以便利读者,而不是为了限制本发明。
此外,应当理解,以下描述的实施方式、实施方式的形式、示例等中的一个或多个可以与其他所述的实施方式、实施方式的形式、示例等中的一个或多个结合。
本发明特别地涉及改进的超声外科夹钳凝结器装置,其被构造为在外科手术中实现组织切割、凝结和/或夹钳。本装置可以被容易地构造为用在开放式外科手术、腹腔镜或内窥镜手术以及机器人辅助的外科手术中。多样化的使用是通过选择地使用超声能量来实现的。当装置的超声部件未受激励,可以根据需要容易地抓住组织并对组织进行操作,而不切割或损坏组织。当超声部件受到激励时,装置允许抓住组织,与超声能量进行连接以实现组织凝结,其中施加增大的压力来有效地实现组织切割与凝结。如果需要,通过适当地操作超声刀,超声能量可以施加到组织,而不需要使用装置的夹钳机构。
如以下的描述中所清楚看到的,由于夹钳凝结器装置的简单结构,其被特别构造为一次性使用。同样,可以设想该装置与外科系统的超声发生器单元结合使用,由此,来自发生器单元的超声能量为该夹钳凝结器装置提供所需的超声致动。应当理解,体现本发明原理的夹钳凝结器装置可以被构造为非一次性使用或者是多次使用的,并且与相关的超声发生器单元不可拆卸地形成一体。但是,对于单个患者使用该装置来说,该夹钳凝结器装置与相关超声发生器单元的可拆卸连接在目前是优选的。
将结合这里描述的超声器械来描述本发明。这样的描述仅是示例性的,并不意图限制本发明的范围和应用。例如,本发明可以与多个超声器械结合使用,这些超声器械包括例如美国专利NoS5,938,633;5,935,144;5,944,737;5,322,055;5,630,420和5,449,370中所描述的那些。
参考图1-3,图示了外科系统19的实施方式,该系统19其包括了根据本发明的超声外科器械100。外科系统19包括超声发生器30和超声外科 器械100,超声发生器30经由线缆22连接至超声换能器50。应当注意,在一些应用中,超声换能器50被称作“手持组件”,因为外科系统19的外科器械被构造为使得在各种手术和操作过程中医生可以抓住并操纵超声换能器50。合适的发生器是Cincinnati,Ohio的Ethicon Endo-Surgery,Inc.出售的GEN 300。
超声外科器械100包括组合式(multipiece)手柄组件68,其适于使操作者与容纳在换能器50中的声音组件的振动隔开。手柄组件68的形状可以形成为能够由使用者以传统的方式握持,但是可以想到,此超声外科器械100原则上通过扳机状设置来抓住并操纵,该扳机状设置由器械的手柄组件提供,如下所述。尽管图示了组合式的手柄组件68,但是手柄组件68可以包括单个或一体的部件。通过将换能器插入到手柄组件68中,超声外科器械100的近端接收超声换能器50的远端并与该远端装配在一起。超声外科器械100可以作为一个单元相对于并从超声换能器50拆装。超声外科器械100可以包括手柄组件68,手柄组件68包括配合外壳部分69、外壳部分70和传输组件71。当该器械被构造用于内窥镜使用时,该给构造的尺寸可以设置为使得传输组件71的外径大约为5.5mm。超声外科器械100的细长传输组件71从器械手柄组件68垂直地延伸。传输组件71可以相对于手柄组件68选择性地旋转,如下进一步的描述的那样。手柄组件68可以由耐用塑料制成,例如聚碳酸酯或液晶聚合物。还可设想手柄组件68或者可以由包含其他塑料、陶瓷或金属的多种材料制成。
传输组件71可以包括外部管状构件或外护套72、内部管状致动构件76、波导管80和端部执行器81(刀79、夹钳臂56以及一个或多个夹钳垫58)。如下所述,外护套72、致动构件76以及波导管或传输杆80可以连接在一起,以便作为一个单元(与超声换能器50一起)相对于手柄组件68旋转。适于将超声能量从换能器50传输到刀79的波导管80可以是柔性的、半柔性或刚性的。波导管80还可以被构造为放大通过波导管80传输到刀79的机械振动,如本领域所公知的。波导管80还可以进一步具有控制沿着波导管80的纵向振动的增益的部件和将波导管80调节到系统共 振频率的部件。具体而言,波导管80可以具有任何合适的横截面尺寸。例如,波导管80可以具有基本上均匀的横截面,或者波导管80可以在各个部分形成锥形或者可以沿着其整个长度形成锥形。在本实施方式的一种形式中,波导管的标定直径为大约0.113英寸,以最小化刀79处的偏移量,使得端部执行器81的近侧部分中的间隙最小。
超声波导管80还可以包括至少一个径向孔或窗孔66,该孔或窗孔66基本上垂直于波导管80的纵向轴线延伸穿过波导管。可以定位在节点处的窗孔66被构造为接收连接器销27,连接器销27将波导管80连接至管状致动构件76,并将管状外壳72、旋钮29联接在一起,用于包括端部执行器81在内的相对于器械手柄组件68的共同旋转。
在本发明的一种实施方式中,超声波导管80的外周中可以形成有多个槽或凹口(未示出)。槽可以位于波导管80的节点处,以作为用于在制造过程中安装阻尼护套62和稳定硅酮环或柔顺支撑的对准指示器。密封件67可以设置在最远侧的节点处并最靠近端部执行器80,以减少位于波导管80与致动构件76之间的区域中的组织、血液和其他材料的通过。
刀79可以与波导管80成为一体并形成为单个单元。在当前实施方式的可选形式中,刀79可以通过螺纹连接件、焊接接头或其他连接机构来连接。刀79的远端设置为靠近反节点(anti-node),以在没有用组织加载声学组件时将声学组件调节到优选的共振频率f0。当超声换能器50被供给能量时,刀79的远端被构造为例如在大约10至500微米的峰-峰范围内纵向运动,例如在55,500Hz的预定振动频率f0下,刀优选在大约20至大约200微米的范围内纵向运动。
根据图示的实施方式,刀79与相关的夹钳臂56一起弯曲。这仅是示例性的,刀79和相应的夹钳臂56可以是本领域技术人员公知的任何形状。
超声换能器50和超声波导管80一起提供了本外科系统19的声学组件,当声学组件由发生器30供能时,声学组件提供用于超声手术的超声能量。外科器械100的声学组件一般包括第一声学部分和第二声学部分。在本实施方式中,第一声学部分包括超声换能器50的超声有效部分 (ultrasonically active portion),第二声学部分包括传输组件71的超声有效部分。此外,在本实施方式中,第一声学部分的远端例如通过螺纹连接件可操作地联接到第二声学部分的近端。
具体参考图2以及图9-11,致动构件76的往复运动驱动夹钳臂打开或闭合。力限制机构91可操作地连接到致动构件76并包括管套环帽98,管套环帽98将远侧垫圈97、远侧波形弹簧96、近侧垫圈95和近侧波形弹簧94紧固到套环93上。套环93包括轴向延伸的凸耳92,凸耳92与管状致动构件76的近侧部分中的合适开口75接合。致动构件76上的圆周槽74接收O形环73,用于与外护套72的内表面接合。
致动构件76与管状外护套72和内部波导管80一起的旋转是由延伸穿过这些部件的连接器销27和旋钮29提供的。管状致动构件76包括细长槽31,连接器销27延伸穿过细长槽31,以提供致动构件76相对于外护套72和内部波导管80的往复运动。
力限制机构91提供了器械100的夹钳驱动机构的一部分,这通过致动构件76的往复运动而影响夹钳臂56的枢转运动。夹钳驱动机构还包括驱动轭形件33,驱动轭形件33可操作地连接至器械的操作扳机34,由此,操作扳机34与可往复运动的致动机构76经由驱动轭形件33和力限制机构91彼此相连。扳机34经由销35和36以及连接件37可旋转地连接至驱动轭形件33,并经由柱38可旋转地连接至驱动轭形件33和外壳68。
扳机34朝向把手68的运动使致动构件76向近侧移动,由此使夹钳臂56向刀79枢转。由扳机34和协作的把手68提供的扳动动作帮助方便有效地操纵并定位器械以及操作器械近侧部分处的夹钳机构,由此组织被有效地驱动推靠到刀79上。扳机34远离把手68的运动使致动构件76向远侧移动,由此使夹钳臂56枢转离开刀79。
具体参考图1-4,其中图示了用于与此超声外科器械100一起使用的夹钳构件60的一种实施方式,并且夹钳构件60被构造为用于与刀79协同动作。刀79与夹钳构件60的组合通常被称作端部执行器81,夹钳构件60通常被称作钳口。夹钳构件60包括可枢转地移动的夹钳臂56,夹钳臂56与组织接合垫或夹钳垫58一起连接到外护套72和致动构件76的远端。在实施方式的一种形式中,夹钳垫58由E.I.Du Pont De Nemours andCompany的商标名为TEFLON的材料制成,这种材料是低摩擦系数的聚合物材料,或者夹钳垫58也可以由任何其他合适的低摩擦材料形成。夹钳垫58安装在夹钳臂56上用于与刀79协作,夹钳臂56的枢转运动将夹钳垫定位为基本上平行于刀79并与刀79接触,由此限定组织处理区域。通过这样的结构,组织被抓在夹钳垫58和刀79之间。如图所示,夹钳垫58可以设置有不平滑的表面(例如锯齿状结构),以与刀79结合来增强对组织的夹持。锯齿状结构或者齿可以提供抵抗刀运动的牵拉。齿还可以对刀和夹钳运动提供相反的牵拉。如本领域技术人员可理解的,锯齿状结构仅是用于防止组织相对于刀79的运动的多种组织接合表面中的一种示例。其他示例性的实施方式包括突起、交叉形图案、胎面花纹、喷丸或喷沙处理的表面等。
特别参考图3a,当前实施方式的第一种形式包括夹钳垫58,夹钳垫58具有比远侧部分58a更平滑的近侧部分58b,近侧部分58b可以没有锯齿状齿或者可设想其他组织接合表面。在夹钳垫58上使用平滑的近侧部分58b允许近侧区域中的组织向远侧移动,随着刀的振动,允许组织移动至刀79的更加有效的区域,以防止组织残留(tagging)。这种构思利用刀79的固有运动分布。由于正弦运动,运动的最大位移或幅值发生在刀79的最远侧部分处,而组织处理区域的近侧部分的幅值大约在远侧尖端幅值的50%的等级。在操作过程中,端部执行器的近侧区域(部分58b的区域)中的组织将失水并变薄,端部执行器81的远侧部分将横切远侧区域中的组织,由此允许近侧区域中的失水并变薄的组织向远侧滑到端部执行器81的更加有效的区域中,以完成组织横切。
在当前实施方式的第二种形式中,夹钳垫58由一个单独的垫构成,该垫具有平滑的近端58b和包括锯齿状结构的远侧部分58a。在当前实施方式的第三种形式中,夹钳垫58可以包括两个分离的部件,即包含锯齿状齿的远侧部分58a’和比远侧部分58a’更平滑的近侧部分58b’。两个分离的部件58a’和58b’的优点是各个垫可以由不同的材料来构造。例如,具有两件式组织垫允许在远端处使用非常光滑的材料而在近端处使用 非常高温的材料,与近端处的高温材料相比,远端处的光滑材料不是特别耐高温,近端处的材料不是特别光滑,因为近端是低幅值的区域。这样的构造使组织垫的材料与刀79的幅值相匹配。
在本发明当前实施方式的第四种形式中,夹钳垫58a’由TEFLON 或任何其他合适的低摩擦材料形成。夹钳垫58b’由基体材料和不同于所述基体材料的至少一种填充材料形成。近侧夹钳垫58b’的表面可以比远侧夹钳垫58a’的表面平滑,或者近侧夹钳垫58b’也可以具有类似于锯齿的构造。
可以从本发明的一种或多种形式中获得一些益处和优点。使组织垫具有基体材料和至少一种填充材料允许选择具有不同硬度、刚度、润滑性度、动摩擦系数、导热系数、耐磨性、热变形温度、玻璃态转变温度和/或熔化温度的基体材料和至少一种填充材料,以提高组织垫的耐磨损性,当使用较高的夹钳力时,这种耐磨损性是很重要的,因为组织垫在较高夹钳力下比在较低夹钳力下磨损得快。在一种试验中,申请人发现,填有15%石墨的聚四氟乙烯组织垫在7磅的夹钳力下与100%聚四氟乙烯的组织垫在1.5磅夹钳力下具有基本相同的磨损。柔性夹钳臂和/或柔性组织垫也可以提高组织垫的耐磨损性,因为柔性构件可以将负载更均匀地分配在组织垫的整个表面上。此实施方式的进一步的优点和形式公开在2004年2月27日提交的序列号为60/548,301、共同转让给本发明受让人的美国临时专利申请中,该文献的整个内容通过参考结合入本文。
在当前实施方式的第五种形式中,具有基体材料和至少两种填充材料的组织垫允许选择具有不同硬度、刚度、润滑性、动摩擦系数、导热系数、耐磨性、热变形温度、玻璃态转变温度和/或熔化温度的基体材料和至少两种填充材料,以提高组织垫的耐磨损性,当使用较高的夹钳力时,这种耐磨损性是很重要的,因为组织垫在较高夹钳力下比在较低夹钳力下磨损得快。在一种试验中,申请人发现,填有15%石墨、30%PTFE的聚酰亚胺组织垫在4.5磅夹钳力下与100%聚四氟乙烯的组织垫在1.5磅夹钳力下具有基本相同的磨损。填有15%石墨、30%PTFE的聚酰亚胺组织垫的优点是增加了热阻,这提高了组织垫整体的耐磨损 性。与PTFE夹钳垫的直至大约660的有效热阻相比,复合聚酰亚胺夹钳垫具有直至大约800至大约1200的有效热阻。可选地,其他材料也可以用于一部分组织垫的(即元件58b’),例如陶瓷、金属、玻璃和石墨。
参考图3a-3e,夹钳臂56的一种形式具有用于容纳两个或多个组织垫的不同形状的槽。这种构造防止了组织垫的误装,并确保了适合的垫装载在夹钳臂56中的正确位置处。例如,夹钳臂56可以包括:远侧T形槽53a,用于接收远侧夹钳垫58a’的T形凸缘53b’;近侧楔形或者燕尾形的槽55a,用于接收近侧夹钳垫58b’的楔形凸缘55b’。翼形止动件51接合近侧夹钳垫58b’的近端,以将夹钳垫紧固到夹钳臂56上。如本领域技术人员应当理解的,凸缘53b’和55b’以及相应的槽53a和55a可以具有其它形状和尺寸,以将夹钳垫紧固到夹钳臂上。图示的凸缘构造仅是示例性的并包含了一种实施方式的具体夹钳垫材料,但是凸缘的具体尺寸和形状可以改变,包括但不限于相同尺寸和形状的凸缘。对于整体的组织垫,凸缘可以是一种构造。此外,其他的翼形止动件也是可以的,并可以包括用于将夹钳垫以机械方式安装至夹钳臂的任何多种方法,例如铆接、粘结、压配合或本领域公知的任何其他紧固手段。
在当前实施方式的第二种形式中,夹钳垫58a和58b被斜切,使得两个垫之间的界面产生叠置,以最小化间隙(图4a、4b)。例如,45度的斜切尽管也会产生一些间隙,但是对组织有影响的间隙量被最小化。
在当前实施方式的第三种形式中,夹钳臂56的高度尺寸从远端向近端增加(D1<D2)。优选地,D2比D1大大约105%至大约120%,更优选地,D2比D1大大约108%至大约113%,最好,D2比D1大大约110%。槽153接收一个夹钳垫58或两个夹钳垫58a和58b的凸缘。锥形夹钳臂56允许使用平的垫,并增加了端部执行器81的近侧部分中的压力以及与刀79的干涉。当夹钳臂56比刀79偏转更大比例时,压力仍然存在于组织垫和刀的界面位置处,并且没有产生间隙。此外,增大的压力有助于抵消刀79的近端处减小的刀振幅,并在夹钳垫58和刀79之间提供相对恒定的压力。
用于插入夹钳垫的方法的第一种形式包括:a)将具有第一形状凸缘的第一和第二夹钳垫插入到夹钳臂56中,夹钳臂56具有接收第一形状凸缘的槽;和b)接合垫止动件,以将夹钳垫紧固在夹钳臂中。在该方法的第二种形式中,一个夹钳垫可以由诸如TEFLON之类的聚合物材料制成,第二夹钳垫可以由基体材料和不同于基体材料的至少一种填充材料制成,并且夹钳臂由金属(例如不锈钢或钛)制成。夹钳垫的组织表面可以是平滑的或者具有组织握持特征,例如锯齿结构。
用于插入夹钳垫的方法的第三种形式包括:a)将具有第一形状凸缘的第一夹钳垫插入到夹钳臂中,夹钳臂具有接收第一形状凸缘的槽;b)将具有第二形状凸缘的第二夹钳垫插入到夹钳臂中,夹钳臂具有接收第二形状凸缘的槽;和c)接合垫止动件,以将夹钳垫紧固在夹钳臂中。在该方法的第四种形式中,一个夹钳垫可以由诸如TEFLON之类的聚合物材料制成,第二夹钳垫可以由基体材料和不同于基体材料的至少一种填充材料制成,并且夹钳臂由金属(例如不锈钢或钛)制成。夹钳垫的组织表面可以是平滑的或者具有组织握持特征,例如锯齿结构。
用于替换夹钳垫58的方法的第一种形式包括步骤:a)解开垫止动件;b)从夹钳臂移除第一夹钳垫;c)从夹钳臂移除第二夹钳垫;d)将第三和第四夹钳垫插入到夹钳臂中;和e)接合垫止动件,以将第三和第四夹钳垫紧固在夹钳臂中。在该方法的第二种形式中,第三和第四夹钳垫可以由诸如TEFLON之类的聚合物材料制成,其他夹钳垫可以由基体材料和不同于基体材料的至少一种填充材料制成,并且夹钳臂由金属(例如不锈钢或钛)制成。夹钳垫的组织表面可以是平滑的或者具有组织握持特征,例如锯齿结构。
现在参考图4,夹钳构件60相对于刀79的枢转运动是通过在夹钳臂56上设置一对枢转点来实现的,这一对枢转点分别与外管72和内管76接合。外管72通过旋钮29牢固地接至手柄68。夹钳臂56经由夹钳臂56上的通孔52a和52b以及外管72上对应的通孔52c和52d可枢转地连接至外管72。紧固销或铆钉57滑动穿过通孔52a-d以将夹钳臂56紧固到外管72。在一种实施方式中,销57激光焊接到夹钳臂56上,使得销57固定到 夹钳臂56并相对于外护套72旋转。
内管76沿着外管72的纵向轴线移动,并通过旋钮29牢固地连接至手柄68。夹钳臂56上的枢轴销54a、b(54a未示出)接合内管76远端处的枢轴孔54c、d(54d未示出)。夹钳臂56至内管76和外管72的枢轴连接使得端部执行器81更加牢固,并使得由于过度的轴向或扭转误用载荷而导致的失效模式最小化。此外,该实施方式增加了端部执行器81的效力能够提供超过1.5磅的夹钳力。由此,致动构件76相对于外护套72和波导管80的往复运动影响夹钳臂56相对于端部刀79的枢转运动。
图4c图示了力示意图并且致动力FA(由致动构件76提供的)和横切力FT(在最佳组织处理区域的中点处测量的)之间的关系为:
FT=FA(X2/X1) 等式[1]
其中FA等于近侧弹簧94的弹簧预载荷(较少的摩擦损耗),在一种实施方式中,如图16c所示,FA等于大约12.5磅,FT等于大约4.5磅。图16c图示了作为扳机34运动的函数的FT和FA的曲线图,并图示了扳机34处的输入力。
FT是在如组织标记61a和61b限定的夹钳臂/刀界面的区域中测量的,在该区域中可进行最佳组织处理。组织标记61a、61b蚀刻在夹钳臂56上或在夹钳臂56上凸起,以为医生提供可见的标记,因此医生可以看到最佳组织处理区域的清晰指示。组织标记61a、61b大约相隔7mm的距离,更优选地,相隔5mm的距离。
超声外科器械100的传输组件71的旋转可以与超声换能器50相对于器械手柄组件68的相对转动一起实现。为了以超声传输的关系将传输组件71连接到超声换能器50,外护套72的近侧部分可以设置有一对扳手用平面46。扳手用平面46允许通过合适的转矩扳手等来施加转矩,以由此允许波导管80连接至超声换能器50。通过旋钮29的操纵,超声换能器50以及传输组件71可以作为一个单元相对于器械的手柄组件68旋转。手柄组件68的内部尺寸被设置为能够容纳超声换能器50的这种相对转动。弹簧28抵靠旋钮29和外壳内表面65进行加载。弹簧28提供了压缩力或者抵抗旋钮29的力,以防止端部执行器81的不经意旋转。
现在参考图2、5、6和16,力限制机构91提供了第一和第二压缩弹簧,即远侧弹簧96和近侧弹簧94。远侧弹簧96可操作地连接至轭形件33,轭形件33由扳机34驱动。近侧弹簧94与远侧弹簧96是可操作的关系。远侧弹簧96产生端部执行器负载,近侧弹簧94保持端部执行器负载的一致性。结果,端部执行器负载被更加严格地控制,并且减少了部件误加载的情况。垫圈97和95是防止远侧弹簧96被完全压缩的安全装置(图5),由此防止弹簧材料发生屈服而使弹簧96在随后的夹钳臂闭合中失去效用。如本领域技术人员应当理解的,双弹簧力限制系统的使用还可应用于涉及夹钳力的其他基于能量(例如RF、微波和激光)的外科装置、以及诸如夹具施放器、抓钳和缝合器之类的机械装置中具有可应用性。
在当前实施方式的一种形式中,远侧弹簧96具有每英寸大于100磅的弹簧常数,并且优选是每英寸大于125磅,最好是每英寸大约135磅。不需要使远侧弹簧96被预加载,但是也可以施加小于10磅的预负载,优选是小于5磅,最好是大约1磅。近侧弹簧94具有每英寸大于25磅的弹簧常数,并且优选是每英寸大于50磅,最好是每英寸大约70磅。近侧弹簧94被施加预负载至实现上述等式1中要求的横切力所需的力,并且该力是夹钳臂56连接装置的机械效益和装置中的摩擦损耗的函数。在当前实施方式的第二种形式中,近侧弹簧94的预加载为大约12.5磅。
现在参考图16a,曲线82图示了致动构件76的力,曲线83代表作为在没有组织或者最小组织负载操作的情况下扳机34的转角(在x轴上,-18.0是夹钳臂56完全打开,0.0是夹钳臂完全闭合并抵靠刀79)的函数的扳机34的力。在点82a处,轭形件33开始偏移或者压缩远侧弹簧96,并且随着扳机34被进一步压下,致动构件76的力增加,直到该力在拐点82b处达到近侧弹簧94的预负载值,并且力曲线的斜率减小。
在图16b中,曲线84图示了致动构件76的力,曲线85代表作为在误用组织负载操作的情况下扳机34的转角的函数的扳机34的力。在点84a处,轭形件33开始偏移或者压缩远侧弹簧96,并且随着扳机34被进一步压下,致动构件76的力增加,直到该力在拐点84b处达到近侧弹簧94的预负载值,并且在该点处,力曲线的斜率减小。
现在参考图2和5,外科器械100还提供了这样的装置,其用于为医生指示扳机已经满程并且夹钳臂56正向组织施加正确的接合力。当医生的握持无意中发生一点点松弛,从夹钳臂56传递到组织的压力可能无意中减小时,这在延长的外科手术或者组织横切活动中非常有用。
在当前实施方式的一种形式中,棘爪簧110支撑在棘爪支撑器112中,棘爪支撑器112位于外壳部分69中。当扳机34完全闭合或者致动构件76已经到达其最近侧的行程时,扳机34上的棘爪翼片114接合并扣合棘爪簧110。棘爪簧110是大致平的,并由弹性塑料制成,当其与翼片114接合时其充分地弯曲,由此为医生提供表示端部执行器81完全闭合的听觉和/或触觉信号。有利的是,当扳机34从完全闭合位置沿相反方向旋转时,翼片114撞击并使棘爪簧110弯曲,由此为医生提供表示端部执行器81不再完全闭合的听觉和/或触觉信号。如本领域技术人员应当理解的,指示器装置可以是触觉的、听觉的、视觉的或其组合。可以使用各种类型的指示器,包括触片开关、整体制动器、悬臂弹簧或本领域技术人员公知的任意数量的机械或电气开关。还有多种装置可以用于向医生提供反馈,包括但不限于灯、蜂鸣器和振动元件。
现在参考图1、2和6-8,外壳68包括近端、远端和在其中纵向延伸的腔59。腔59被构造为容纳开关组件300和换能器组件50,换能器组件50经由开关组件300与外壳68接合。
换能器50包括紧固地布置在换能器主体50中的第一导电环400和第二导电环410。在当前实施方式的一种形式中,第一导电环400包括环构件,环构件布置在换能器50和角状件(horn)130之间。优选地,第一导电环400靠近腔162中的凸缘构件160形成或形成为凸缘构件160的一部分,并与其他电气部件电绝缘。第一导电环400锚定至非导电平台(未示出)等上并从那里向上延伸,非导电平台形成在换能器主体50中。第一导电环400通过一根或多个导线(未示出)电连接到线缆22(图1),导线沿着换能器主体50的长度延伸到第一导电环400。
换能器50的第二导电环410类似地包含布置在换能器主体150和角状件130之间的环构件。第二导电环410布置在第一导电环400和角状件 130之间,由此第一和第二导电环400、410是同心的构件。类似地,第二导电环410与第一导电环400和包含在换能器50中的其他电气部件电绝缘。类似于第一导电环400,第二导电环410优选锚定到非导电平台并从那里向上延伸。应当理解,第一和第二导电环400、410彼此充分地间隔开,使得它们彼此电绝缘。这可以通过在第一与第二导电环400、410之间或者在环400、410与换能器50中的其他构件之间布置一个或多个间隔件413来完成。第二导电环410也通过一根或多根导线(未示出)电连接到线缆22(图1),导线沿着换能器50的长度延伸到第二导电环410。由此,第二导电环410被设置为部分地限定了从线缆22到开关机构300的第二电通路。合适的超声换能器50是由Cincinnati,Ohio的EthiconEndo-Surgery,Inc.出售的Model No.HP054。
在当前实施方式的一种形式中,换能器50的远端螺纹连接到传输杆80的近端。换能器50的远端还与开关组件300接合,以便为医生提供外科器械100上的手指致动控制。
开关组件300包含按钮组件310、弯曲电路组件330、开关外壳350、第一弹簧滑环式导体360和第二弹簧滑环式导体370。开关外壳350通常是圆柱形的,并通过开关组件350和外壳部分69、70上的支撑安装座支撑在手柄组件68中。外壳350限定了第一腔353、安装凸台352和第二腔351。腔353的尺寸被设置为能够接收换能器50的近端,由此角状件130穿过腔351与传输杆80接合。安装凸台352接收滑环导体360和370,滑环导体360和370又分别电接合环触头400和410。定位销354和扣合销355与弯曲电路组件330和按钮组件310的相应孔对齐,以将所有部件紧固在一起,如下所述。
现在具体参考图8a,滑环导体360和370通常是末端开口的O形弹簧,它们滑到安装凸台352上。每个弹簧滑环分别包括两个压力接触点(361a-b和371a-b),两个压力接触点分别接触换能器50的环导体400和410。滑环360和370的弹簧张力使得在触点361a-b、371a-b和导体400、410之间产生确定接触(positive contact)。明显的是,即使在器械的使用过程中医生旋转换能器50,滑环结构也使电接触均匀。各个滑环的柱364和374分别电连接至弯曲电路330中的相应导体以形成电路,如图8c所示。
弯曲电路330在按钮311a、311b、312a、312b和发生器30之间经由换能器50提供了机电接合。弯曲电路包括四个触片开关332a、332b和334a、334b,触片开关332a、332b和334a、334b通过压下按钮311a、311b或312a、312b(分别对应于按钮组件310)来机械地致动。触片开关322和334是电接触的开关,当压下时,它们提供电信号至发生器30,如图8c的电连接示意图所示。弯曲电路330还包含位于二极管封装336中的两个二极管,如图8c所示。弯曲电路330提供了导体335和337,如本领域技术人员所公知的,导体335和337分别经由电翼片364和374连接到滑环导体360和370,电翼片364和374又提供电接触至环导体400和410,环导体400和410又连接至线缆22中的导体,线缆22连接至发生器30。翼片364和374焊接到导体335和337。
弯曲电路330通常绕开关外壳350缠绕,使得触片开关334a、334b和332a、332b与开关外壳350上的相应背衬表面356a、3566和358a、358b相结合,在操作过程中,背衬表面为触片开关提供了薄膜支撑,如下所述。触片开关334a、334b和332a、332b可以通过任何方便的方法(例如粘结)固定地安装到背衬表面356a、356b和358a、358b。弯曲电路经由开关组件300上的定位销354和扣合销355以及弯曲电路330上的相应定位孔338和扣合孔339紧固至开关外壳350。
层叠在弯曲电路顶部上的是按钮组件310,按钮组件310具有与弯曲电路330相应的鞍状,并通常围绕开关外壳350进行缠绕。按钮组件310包含四个按钮,即具有相应的压力柱315a、315b和314a、314b的远侧按钮312a、312b和近侧按钮311a、311b。所述按钮连接到悬臂元件313a、313b和316a、316b,在按钮被压下后,这些悬臂元件提供了反弹作用。容易理解,通过压下按钮311a-b和312a-b,相应的压力柱314a-b和315a-b压靠相应的触片开关334a-b和332a-b,以启动图8c所示的电路。开关312a和312b是平行的,使得医生可以使用左手或者右手来操作按钮。类似地,开关311a和311b是平行的,使得医生可以使用左手或者右手来操作按钮。当医生压下开 关312a或312b时,发生器将响应一定的能量水平(例如最大(“max”)功率设定);当医生压下开关311a或311b时,发生器将响应一定的能量水平(例如最小(“min”)功率设定),这符合用于按钮位置和相应功率设定的已经被接受的产业实践。
可选地,按钮可以模制到开关外壳350中或者模制到手柄组件68中,以减少部件的数量并增加整个装置的可靠性。按钮可以通过小的悬臂部分来安装,这允许将按钮牢固地安装到其他部件,同时允许用较小的力来致动按钮。
现在参考图12-15,当前实施方式的一种形式允许以为医生提供人体工程学的握持和操作的方式来构造开关311a、311b和312a、312b。无论握持适于右手的外科器械100还是握持适于左手的外科器械100,开关可以放置在医生拇指的自然摆动范围内。在当前实施方式的第二种形式中,开关设置在外壳68上,以防止在医生压下扳机34或者转动旋钮29时,在器械的与拇指相反的一侧上无意中致动按钮。在当前实施方式的第三种形式中,一系列的隔板(例如脊和/或凹槽或“峰和谷”)一体地形成于外壳68上。在一种示例中,外壳限定了第一表面,该一系列的隔板限定了至少一个第二表面,使得第二表面高于外壳表面。隔板还可以限定低于外壳表面的第三表面。如图1、2所示,开关312a、312b由上脊320和下脊324包围。脊320和324可以是分离的物理元件(两个彼此分离),或者在不脱离本发明范围的情况下,脊320和324可以实质上是连续的。此外,脊320和324可以在外壳68的整个上部上连续,如图12-15所示,或者脊320和324可以更加分离,如图1和2所示。即使由于脊使手指通过按钮平面的上方而使手指横过按钮,开关312a、312b的这种构造和情况可以防止不经意地致动按钮。脊还可以为医生提供与按钮的位置以及按钮是否在最小或最大功率致动范围内的触觉反馈。很显然,开关312a、312b可以由脊320和324围绕,并且按钮311a、311b位于脊320的上方和近侧。这样的触觉反馈对于医生是很重要的,使得医生可以连续地接近手术部位,但是确定地知道哪个按钮正被致动。在当前实施方式的其它形式中,开关312a、312b嵌入在凹部322中并由脊320和324进一步围绕。
参考图12,医生的左手接触器械100。食指和中指准备好启动扳机34,无名指和小指抓住手柄39。拇指传统地定位为向上掠过以致动按钮312a或311a。脊320和324延伸经过外壳68的上部。
在图13中,图示了图12所示器械100的相反侧,示出按钮311b和312b。这里,医生的食指操作旋钮29以旋转端部执行器81。如可以看到的,按钮312b可能会受到食指的不经意致动。但是,脊324使得食指升高到按钮312b的平面的上方,由此减少了不经意致动的危险。
在图14中,医生压下扳机34来闭合夹钳臂56抵靠刀79,并且左拇指容易地操作按钮312b来启动最大功率。
在图15中,医生压下扳机34来闭合夹钳臂56抵靠刀79,并且左拇指容易地操作按钮311b来启动最小功率。
参考图17,示出了外科器械100的一种形式,该图以图形示出了医生的手指在器械100上的放置。在器械100的致动中,将食指382和中指384放在扳机34上。(使用食指和中指来启动扳机34仅是示例。手比较小的医生可以选择用中指和无名指来致动扳机34,由此使得食指能够旋转旋钮29或者甚至使用无名指和小指来致动扳机34。)扳机34包含基座元件45,基座元件45包含棘爪翼片114和与轭形件33的连接装置,如下所述。安装到基座元件45上的是大致T形的手指接触件43,手指接触件43与基座元件45一起限定了两个大致U形的开口,即食指槽42和中指槽44。T形手指接触件43的最远侧表面部分限定了致动表面41,手指382和384可放置在致动表面41上。槽42和44的尺寸被设置为容纳不同尺寸的手指,很显然这是取决于医生的性别和尺寸的共有变量。在当前实施方式的第一种形式中,槽42和44的尺寸基于手指尺寸的从5%女性到95%男性的人类学数据。在当前实施方式的第二种形式中,槽42和44是锥形的,由此每个槽开口的尺寸大于每个槽42和44的基部的尺寸。这种构造有利地允许尺寸不同的手指紧密地位于各个槽中,并最小化手指与槽壁之间的间隙。
现在参考图10和11,当扳机34处于其最远侧位置(图10)时,夹钳臂56相对于刀79完全打开。手指382和384可以分别放在槽42和44中或者可选地放在表面41上,以致动扳机34通过箭头47所示的弓形路径。当扳机到达其整个近侧行程时(当棘爪翼片114接合棘爪簧110时),夹钳臂56相对于刀79处于完全闭合的位置(图11)。为了使扳机沿着其行程47反向,手指382和384接合槽42和44并向远侧推扳机34,以打开端部执行器。夹钳臂56没有被偏压打开,使得医生不能经由表面41来控制夹钳臂56的打开。
现在参考图18,与图2具有类似参考标号的元件具有与上述类似的功能。特别的注意力集中在用于致动端部执行器81的可选手柄组件168上。手柄组件168包括连接至右护罩169和左护罩170的两个枢转手柄部分420和422。
右护罩169适于借助在左护罩170上形成的多个向内的凸爪扣合在左护罩170上,以形成外壳171。当左护罩170安装到右护罩169上时,在左护罩170和右护罩169之间形成腔,以容纳形成手柄组件168的各种部件,如下进一步所述。窗孔172和174也形成为容纳拇指环或手柄部分420和指环或手柄部分422,手柄部分420和422位于左、右护罩的外部,以致动容纳在左、右护罩中的连接装置。窗孔173也形成在护罩的近端处以,容纳换能器50(见图8b)。
手柄组件168包括U形轭形件424,U形轭形件424分别借助槽421a、421b和销423a、423b可滑动地安装在外壳169和170中。手柄420的远端在孔402处经由销423a安装到右护罩169和轭形件,手柄420的近端经由连接件428安装到轭形件424,连接件428经由销426安装到孔404并经由销430安装到孔410。手柄422的远端在孔406处经由销423b安装到右护罩169和轭形件,手柄422的近端经由连接件432安装到轭形件424,连接件432经由销434连接到孔408并经由销430连接到孔412。在实践中,随着手柄420和422远离外壳171移动(例如,医生的拇指与手柄420配合,医生的食指和中指与手柄422配合),端部执行器81移动离开刀79,以形成打开的钳口(打开位置),随着手柄420和422向着外壳171移动,端部执行器81向着刀79旋转以捕获组织(闭合位置)。
在当前实施方式的一种形式中,棘爪簧482被支撑在外壳部分171中。棘爪凸轮480在轭形件424上旋转,并在手柄420和422处于完全闭合的位置时接合并弹回棘爪簧482。棘爪簧482通常由柔性塑料制成,当其接合凸轮480时能够充分地变形,由此为医生提供表示端部执行器完全闭合的听觉信号。有利的是,当手柄420和422从完全闭合的位置在相反方向上旋转时,凸轮480撞击并使棘爪簧482变形,由此为医生提供表示端部执行器81的完全闭合不再存在的听觉信号。
现在参考图24,示出了当前实施方式的第二种形式,致动器柱433安装到手柄422并接合位于外壳组件171上的由硅橡胶覆盖的触片开关435。当手柄422完全闭合时,柱433压靠硅橡胶,这又将力传递到触片开关435,由此允许开关为医生提供听觉和触觉反馈。在一种实施方式中,柱433是直径为0.170英寸的圆柱,其中间具有0.070英寸的槽。用于硅橡胶材料的优选硬度是20肖氏硬度A(Shore A)。
现在参考图23,此外还包围在外壳171中的是连接器450、滑环452、454、弯曲电路456和摇臂开关462。摇臂开关462经由窗孔469可旋转地安装到右护罩169,开关462和464定位在外壳171外部,使医生能够操作。开关462和464经由摇臂466以机械的方式连接,摇臂466包含与窗孔469接合的枢转柱468。在此构造中,开关462和464不能被同时压下,如果被同时压下,则可能从发生器30提供出错信息。弯曲电路456经由换能器50为开关464、466与发生器30之间提供了机电接合(见图8b)。参考图21,弯曲电路456的远端处包括两个触片开关500和502,通过压下相应的开关464和466来分别机械地致动触片开关500和502。触片开关500和502是电接触开关,当压下时,它们提供电信号至发生器30,如图22的电气布线示意图所示。弯曲电路456还包含位于二极管封装504中的两个二极管,如图22所示。弯曲电路456提供导体,如本领域技术人员所公知的,导体经由连接器450连接至滑环导体452和454,滑环导体452和454又提供电接触至环导体400和410(见图8b),环导体400和410又连接到线缆32中的导体,其中线缆32连接到发生器30。
具体参考图19和20a-b,滑环导体452和454通常是末端开口的O形弹簧,它们分别滑到连接器450的安装表面453和455上。每个弹簧滑环包 括两个压力接触点(510a-b和522a-b),两个压力接触点分别接触手持件50的相应环导体400和410。滑环452和454的弹簧张力使得在触点510a-b、522a-b和导体400、410之间产生确定接触。明显的是,即使在器械的使用过程中医生旋转手持件50,滑环结构也使电接触均匀。各个滑环的柱512和524分别电连接至弯曲电路456中的导体,以形成电路,如图22所示。
再次参考图18,旋转联接器130可旋转地接合左、右护罩169、170的远端。旋钮129连接到旋转联接器130,由此两个弹簧翼片175和175a(未示出)提供向外的张力或者抵靠旋钮129内表面的力,以抑制端部执行器81的不经意旋转。
在本发明的可选形式中,手柄420和422的内表面上具有接触柔软且模制的热塑性弹性体衬垫550。塑性衬垫550使医生舒适并防止了手指和手的疲劳。与现有技术的平滑塑性表面接触面相反,塑性衬垫550还增强了手柄与医生的拇指和手指之间的握持表面。由于能够容纳多种尺寸的男性和女性医生的手指并且提供舒适且确定的握持表面,这是特别有利的。塑性衬垫550可以是平滑的或者具有模制到衬垫550的表面上的形状,例如肋,如图23和24所示。其他的形状可以是突起、峰和谷。如本领域技术人员应当理解的,各种其他的形状和接触面也在本发明的范围内。塑性衬垫550在医生的手指与扳机34之间的界面上也是有用的(图12)。
在当前实施方式的一种形式中,软接触衬垫550具有从大约35肖氏硬度A至大约75肖氏硬度A的硬度(硬度),更具体而言从大约50肖氏硬度A至大约60肖氏硬度A。这样合适的材料可以从Exton,PA的LNP(物料编号8211-55 B100 GYO-826-3)和Akron,OH的Advanced ElastomerSystems(物料编号8211-55B100)得到。
软接触材料可以在医生手头正集中于手术时有助于医生识别器械的具体特征。例如,具有一种形状界面的“软接触”可以放在“max”按钮上,而具有第二种形状界面的“软接触”可以放在“min”按钮上,使得医生可以容易地识别各个按钮,而不需要分散外科位置处的注意力。“软 接触”也用于旋钮29和129上,以识别端部执行器81的各个旋转位置。
尽管已经通过一些实施方式的描述说明了本发明,但是申请人的意图不是将所附权利要求的精神和范围限制在这样的细节。对本领域技术人员来说,在不脱离本发明范围的情况下,可以进行多种变化、改变和替换。此外,与本发明相关的各个元件的结构可以可选地描述为用于提供由所述元件执行的功能的装置。由此,本发明的范围意图仅由所附权利要求的精神和范围来限定。
Claims (43)
1.一种超声夹钳凝结器装置,包括:
具有近端和远端的超声波导管;
连接到所述超声波导管的所述远端上的超声致动的刀;
能够相对于所述刀枢转的夹钳构件,该夹钳构件包括可枢转地移动的夹钳臂和与所述夹钳臂接合的组织垫,该组织垫具有第一组织接合表面,所述第一组织接合表面限定远侧的具有粗糙表面的第一区域和近侧的具有平滑表面的第二区域,所述夹钳构件具有打开位置和闭合位置,在所述打开位置中,所述夹钳构件的至少一部分与所述刀间隔开,在所述闭合位置中,所述夹钳构件邻近所述刀,用于将组织夹钳在所述组织垫和所述刀之间。
2.根据权利要求1所述的超声夹钳凝结器装置,其中,所述组织垫由具有低摩擦系数的材料形成。
3.根据权利要求2所述的超声夹钳凝结器装置,其中,所述组织垫由聚四氟乙烯(PTFE)形成。
4.根据权利要求1所述的超声夹钳凝结器装置,其中,所述组织垫包括具有凸缘构件的第二接合表面,以与所述夹钳臂接合。
5.根据权利要求4所述的超声夹钳凝结器装置,其中,所述夹钳臂包括用于能够滑动地接收所述凸缘构件的槽。
6.根据权利要求4所述的超声夹钳凝结器装置,其中,所述凸缘构件是T形的。
7.根据权利要求4所述的超声夹钳凝结器装置,其中,所述凸缘构件是楔形的。
8.根据权利要求1所述的超声夹钳凝结器装置,其中,所述第一区域限定有锯齿状结构。
9.根据权利要求1所述的超声夹钳凝结器装置,还包括在操作上与所述超声波导管、所述刀和所述夹钳构件相联的可旋转元件,所述可旋转元件能够旋转,以使所述刀和所述夹钳构件进行相应的旋转。
10.一种组装超声夹钳凝结器装置的方法,包括如下步骤:
提供:
具有近端和远端的超声波导管;
连接到所述超声波导管的所述远端上的超声致动的刀;
能够相对于刀枢转的夹钳构件,该夹钳构件包括可枢转地移动的夹钳臂和与所述夹钳臂接合的组织垫,该组织垫具有第一组织接合表面和第二接合表面,所述第一组织接合表面限定有远侧的具有粗糙表面的第一区域和近侧的具有平滑表面的第二区域,所述第二接合表面具有凸缘构件,所述夹钳构件具有打开位置和闭合位置,在所述打开位置中,所述夹钳构件的至少一部分与所述刀间隔开,在所述闭合位置中,所述夹钳构件邻近所述刀,用于将组织夹钳在所述夹钳臂和所述刀之间,所述夹钳臂包括用于可滑动地接收所述凸缘构件的槽;以及
将所述凸缘构件可滑动地接合在所述槽中。
11.一种超声夹钳凝结器装置,包括:
具有近端和远端的超声波导管;
连接到所述超声波导管的所述远端上的超声致动的刀;
限定远侧部分和近侧部分并可相对于所述刀枢转的夹钳构件,该夹钳构件包括可枢转地移动的夹钳臂、与所述夹钳臂接合且位于远侧的第一组织垫、与所述夹钳臂接合且位于近侧的第二组织垫,所述第一组织垫具有粗糙表面的第一组织接合表面,并且第二组织垫具有光滑表面的第二组织接合表面,所述夹钳构件具有打开位置和闭合位置,在所述打开位置中,所述夹钳构件的至少一部分与所述刀间隔开,在所述闭合位置中,所述夹钳构件邻近所述刀,用于将组织夹钳在所述第一、第二组织垫和所述刀之间。
12.根据权利要求11所述的超声夹钳凝结器装置,其中,所述第一组织垫由聚四氟乙烯(PTFE)形成,而所述第二组织垫不由聚四氟乙烯形成。
13.根据权利要求11所述的超声夹钳凝结器装置,其中,所述第二组织垫由聚酰亚胺形成。
14.根据权利要求13所述的超声夹钳凝结器装置,其中,所述第二组织垫由填充有大约30%聚四氟乙烯的聚酰亚胺形成。
15.根据权利要求13所述的超声夹钳凝结器装置,其中,所述第二组织垫由填充有大约30%聚四氟乙烯和大约15%石墨的聚酰亚胺形成。
16.根据权利要求11所述的超声夹钳凝结器装置,其中,所述第一组织垫包括具有第一凸缘的第一接合表面,所述第二组织垫包括具有第二凸缘的第二接合表面。
17.根据权利要求16所述的超声夹钳凝结器装置,其中,所述夹钳臂包括用于能够滑动地接收所述第一和第二凸缘的槽。
18.根据权利要求16所述的超声夹钳凝结器装置,其中,所述第一凸缘是T形的。
19.根据权利要求16所述的超声夹钳凝结器装置,其中,所述第二凸缘是T形的。
20.根据权利要求16所述的超声夹钳凝结器装置,其中,所述第一凸缘是楔形的。
21.根据权利要求16所述的超声夹钳凝结器装置,其中,所述第二凸缘是楔形的。
22.根据权利要求16所述的超声夹钳凝结器装置,其中,所述第一凸缘是T形的,而所述第二凸缘是楔形的。
23.根据权利要求19所述的超声夹钳凝结器装置,其中,所述第一凸缘是T形的。
24.根据权利要求20所述的超声夹钳凝结器装置,其中,所述第二凸缘是T形的。
25.根据权利要求17所述的超声夹钳凝结器装置,其中,所述远侧部分限定用于接收所述第一凸缘的第一槽,所述近侧部分限定用于接收所述第二凸缘的第二槽,并且其中所述第一和第二槽具有不同的横截面形状。
26.根据权利要求25所述的超声夹钳凝结器装置,其中,所述第一槽限定有T形横截面,而所述第二槽限定有楔形横截面。
27.根据权利要求11所述的超声夹钳凝结器装置,其中,所述第一组织接合表面限定锯齿状结构。
28.根据权利要求11所述的超声夹钳凝结器装置,还包括在操作上与所述超声波导管、所述刀和所述夹钳构件相联的可旋转元件,所述可旋转元件能够旋转,以使所述刀和所述夹钳构件进行相应的旋转。
29.一种组装超声夹钳凝结器装置的方法,包括如下步骤:
提供:
具有近端和远端的超声波导管;
连接到所述超声波导管的所述远端上的超声致动的刀;
能够相对于刀枢转的夹钳构件,该夹钳构件包括可枢转地移动的夹钳臂、与所述夹钳臂接合且位于远侧的具有粗糙表面的第一组织接合表面和第一凸缘的第一组织垫、以及与所述夹钳臂接合且位于近侧的具有光滑表面的第二组织接合表面和第二凸缘的第二组织垫,所述夹钳构件具有打开位置和闭合位置,在所述打开位置中,所述夹钳构件的至少一部分与所述刀间隔开,在所述闭合位置中,所述夹钳构件邻近所述刀,用于将组织夹钳在所述第一、第二组织垫和所述刀之间,所述夹钳构件包括用于能够滑动地接收所述第一、第二凸缘的槽;以及
将所述第一凸缘能够滑动地接合在所述槽中,并将所述第二凸缘能够滑动地接收在所述槽中。
30.一种超声夹钳凝结器装置,包括:
包含致动器的外壳;
具有近端和远端的外管,所述近端连接到所述外壳;
具有近端和远端并且还定位在所述外管中的超声波导管;
连接到所述超声波导管的远端上的超声致动的刀;
夹钳构件,能够相对于所述刀枢转,用于将组织夹钳在所述夹钳构件和所述刀之间,该夹钳构件包括可枢转地移动的夹钳臂和与所述夹钳臂接合的具有第一组织接合表面的组织垫,所述第一组织接合表面限定远侧的具有粗糙表面的第一区域和近侧的具有平滑表面的第二区域;
致动器元件,其能够在所述外管内往复地运动并可操作地连接到所述致动器和所述夹钳构件,所述致动器元件包括:
位于所述致动器和所述夹钳构件之间的第一压缩弹簧,其中,所述第一压缩弹簧提供力以使所述夹钳构件相对于所述刀进行枢转运动;
位于所述第一压缩弹簧和所述致动器之间的第二压缩弹簧,其中,所述第二压缩弹簧限制从所述致动器施加到所述夹钳构件的力。
31.根据权利要求30所述的超声夹钳凝结器装置,其中,所述第一压缩弹簧的弹簧常数大于每英寸100磅。
32.根据权利要求31所述的超声夹钳凝结器装置,其中,所述第一压缩弹簧的弹簧常数大于每英寸125磅。
33.根据权利要求32所述的超声夹钳凝结器装置,其中,所述第一压缩弹簧的弹簧常数大约为每英寸135磅。
34.根据权利要求30所述的超声夹钳凝结器装置,其中,所述第二压缩弹簧的弹簧常数大于每英寸25磅。
35.根据权利要求34所述的超声夹钳凝结器装置,其中,所述第二压缩弹簧的弹簧常数大于每英寸50磅。
36.根据权利要求30所述的超声夹钳凝结器装置,其中,所述第二压缩弹簧的弹簧常数大约为每英寸70磅。
37.根据权利要求30所述的超声夹钳凝结器装置,其中,所述第二压缩弹簧被预加载到提供所需横切力的值。
38.一种超声夹钳凝结器装置,包括:
包含致动器的外壳;
具有近端和远端的外管,所述外管的近端连接到所述外壳;
致动器元件,其能够在所述外管内往复地运动并可操作地连接到所述致动器;
具有近端和远端并且还定位在所述外管中的超声波导管;
连接到所述超声波导管的所述远端上的超声致动的刀;
具有第一组织接合表面的组织垫,所述第一组织接合表面限定远侧的具有粗糙表面的第一区域和近侧的具有平滑表面的第二区域;和
具有近端和远端、用于接收组织垫的至少一个槽的夹钳构件,并且所述夹钳构件的远端和所述组织垫的高度之和小于所述夹钳构件的近端和所述组织垫的高度之和。
39.根据权利要求38所述的超声夹钳凝结器装置,其中,所述组织垫还包括一对窗孔和一对驱动销,所述一对窗孔用于接收靠近所述外管的远端可枢转地安装的枢轴杆,所述一对驱动销用于可操作地接合所述致动器元件,其中,所述夹钳构件能够相对于所述刀在打开位置和闭合位置之间运动。
40.根据权利要求39所述的超声夹钳凝结器装置,其中,所述枢轴杆焊接到所述外管上。
41.根据权利要求38所述的超声夹钳凝结器装置,其中,所述夹钳构件近端的高度比所述夹钳构件远端的高度高105%到120%。
42.根据权利要求38所述的超声夹钳凝结器装置,其中,所述夹钳构件近端的高度比所述夹钳构件远端的高度高108%到113%。
43.根据权利要求38所述的超声夹钳凝结器装置,其中,所述夹钳构件近端的高度比所述夹钳构件远端的高度高110%。
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AU2012200268B2 (en) | Ultrasonic surgical instrument |
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