CN101674782B - 外科器械 - Google Patents
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Abstract
一种外科器械,包括限定纵向轴线的细长的传输波导管。该传输波导管具有远端和近端。至少一个撞击表面形成在所述近端上并能够接收振动能量。
Description
相关申请的交叉引用
本发明涉及以下同时提交的美国专利申请,这些申请整体通过引用合并在此:
(1)题为(ULTRASONIC SURGICAL INSTRUMENTS,代理人卷号为No.060878/END6051USNP)、序列号为No.11/726625的美国专利申请;
(2)题为(SURGICAL INSTRUMENTS,代理人卷号为No.060877/END6050USNP)、序列号为No.11/726620的美国专利申请;
(3)题为(ULTRASONIC SURGICAL INSTRUMENTSAND CARTILAGE BONE SHARPING BLADES THEREFOR,代理人卷号为No.060876/END6049USNP)、序列号为No.11/726621的美国专利申请。
技术领域
本发明涉及一种外科器械。
背景技术
包括空心和实心器械的超声器械被用来对很多医学病症进行安全和有效的治疗。超声器械、特别是实心超声器械是有利的,因为它们可用来利用以超声频率传输至外科端部执行器的机械振动形式的能量切割和/或凝结有机组织。在被以合适的能量水平传输至有机组织且利用合适的端部执行器时,超声振动可以用来切割、解剖、提升、凝结或者灼烧组织,或者用来将肌肉组织与骨分离。利用实心技术的超声器械由于可以从超声换能器经过波导管传输至外科端部执行器的超声能量的量而尤其有利。这些器械可以用于开放式手术或者微创手术,例如内窥镜或者腹腔镜手术,其中,端部执行器通过套管针到达手术部位。
以超声频率启动或者激励这种器械的端部执行器(例如,切割刀)诱发纵向振动,该纵向振动在邻近组织内生成局部热,由此促进切割和凝结。由于超声器械的性质,可以设计具体的超声致动的端部执行器来执行多种功能,包括例如切割和凝结。
例如,通过电激励换能器来在外科端部执行器中诱发超声振动。换能器可以由器械手持件中的一个或多个压电或者磁致伸缩元件构造。换能器部分产生的振动经由从该换能器部分延伸到外科端部执行器的超声波导管传输至外科端部执行器。波导管和端部执行器被设计成以与换能器相同的频率共振。因此,当端部执行器连接到换能器时,整体系统的频率与换能器自身的频率相同。
在端部执行器的尖端处的纵向超声振动的振幅d表现为共振频率的简单正弦函数,如由以下公式给出:
d=A sin(ωt)
其中:
ω=角频率,其等于2π乘以循环频率f;且
A=零-峰振幅
纵向偏离被定义为峰-峰(p-t-p)振幅,其正好是正弦波振幅的两倍或者2A。
实心超声器械可被分成两种类型,单元件端部执行器装置和多元件端部执行器。单元件端部执行器装置包括例如手术刀和球凝结器等器械。多元件端部执行器可以在需要很大压力来有效地将超声能量耦合到组织时采用。例如夹紧凝结器的多元件端部执行器包括将组织压向超声刀的机构。超声夹紧凝结器可以被采用于切割和凝结组织、尤其是松弛且不受支撑的组织。包括与夹具结合的超声刀的多元件端部执行器对组织施加压力或者偏置力,以促进组织的更快凝结和切割,且使刀动作衰减更少。
整形外科或者整形术是关注急性、慢性、创伤性和过劳性伤害和肌肉骨骼系统的其它异常的外科分支。整形医生使用外科和非外科手段处理包括关节炎、外伤和先天性畸形等大部分肌肉骨骼疾病。整形手术包括手部手术、肩部和肘部手术、全关节重建(关节造形术)、儿科整形术、脚和脚踝手术、脊椎手术、肌肉骨骼肿瘤学、外科运动医学和骨科创伤。这些手术常常要求使用专门的外科器械来治疗较软的肌肉骨骼组织(例如,肌肉、腱、韧带)和较硬的肌肉骨骼组织(例如,骨)。常常,这些整形外科器械是通过手操作的,并且单次手术可能要求交换多种器械。因此,希望多种电动超声器械和无动力超声器械来执行这些整形手术过程,其比当前利用传统的整形外科器械可实现的更有效率且精确,同时使对不同类型的肌肉骨骼组织进行切割、成形、钻孔时交换器械的需要最小化。
发明内容
在一个总的方面,多种实施方式涉及一种外科器械,该外科器械包括限定纵向轴线的细长的传输波导管。该传输波导管具有远端和近端。至少一个撞击表面形成在近端上且能够接收振动能量。
附图说明
各种实施方式的新颖特征详细阐述在权利要求中。但是,通过参考结合以下附图的以下描述可以最好地理解各种实施方式,不论是操作的机构和方法还是其进一步的目的和好处。
图1示出了超声系统的一种实施方式。
图2示出了用于超声器械的连接接合器/接头的一种实施方式。
图3示出了能够连接到图1中描述的超声系统的超声手持件组件的超声子组件的一种实施方式。
图4是超声器械的一种实施方式的俯视透视图。
图5是图4中所示的实施方式的超声器械的沿纵向轴线“L”截取的剖视图。
图6是沿纵向轴线“L”截取的振动外科器械的一种实施方式的剖视图。
图7是沿纵向轴线“L ”截取的振动外科器械的一种实施方式的剖视图。
图8是沿纵向轴线“L ”截取的超声器械的一种实施方式的剖视图。
图9是沿纵向轴线“L”截取的超声器械的一种实施方式的剖视图。
图10是包括撞击区域的超声器械的一种实施方式的侧视图。
图11是包括撞击区域的超声器械的一种实施方式的侧视图。
图12是包括撞击区域的超声器械的一种实施方式的侧视图。
图13是包括撞击区域的超声器械的一种实施方式的侧视图。
图14-17示出了在远端包括端部执行器的超声器械的一种实施方式;图14是夹钳处于闭合位置的超声器械的一种实施方式的侧向透视图;图15和16是夹钳处于部分打开位置的超声器械的侧向透视图;且图17是夹臂组件处于闭合位置的超声器械的侧向透视图。
图18-20示出了可以与图14-17中讨论的超声器械一起采用的端部执行器的一种实施方式;图18是夹臂组件处于闭合位置的端部执行器的一种实施方式的俯视透视图;图19是夹臂组件处于打开位置的端部执行器的一种实施方式的俯视透视图;图20是夹钳处于打开位置的端部执行器的一种实施方式的分解图。
图21-24示出了夹钳从图21中的打开位置转换成图24中的闭合位置和图22和23中的中间位置。
图25和26示出了可以与图14-17中讨论的超声器械一起采用的端部执行器的一种实施方式;图25是夹臂组件处于打开位置的端部执行器的一种实施方式的俯视透视图;且图26是夹钳处于打开位置的端部执行器的一种实施方式的分解图。
具体实施方式
在详细解释本发明的实施方式之前,应当注意,本发明的应用或使用并不局限于在附图和说明书中说明的零件的结构和配置的细节。本发明示出的实施方式可以实施或者并入其它实施方式、变型和修改中,且可以多种方式实践或执行。例如,以下公开的外科器械和刀结构仅仅是说明性的,并不意味着对本发明的范围或应用的限制。此外,除非另外指出,本文中采用的术语和表述是出于便于读者理解来描述本发明的说明性实施方式的目的选择的,并不用于限制本发明。
这里描述的多种实施方式整体涉及外科器械。尽管这些外科器械可以采用在整形外科手术中,但所描述的实施方式并不局限于此,因为这些器械可以在该特定的医学分支之外找到有用应用。这里描述的多种实施方式涉及可以单独使用或者结合受超声驱动的外科器械使用的外科器械。在一些实施方式中,外科器械可以手动驱动或者电驱动,或者可以手动和电组合驱动。能够操作在多个有动力和无动力状态模式的外科器械可以减少手术室中的器械总数、减少用于给定过程的器械交换数,并且减少用于给定过程的需要灭菌的器械数。在其它实施方式中,外科器械可以获得有用的纵向共振以帮助在没有电动致动器或者超声换能器的情况下切割、再成形或凝结组织。在另一些实施方式中,电动超声器械可与手动技术结合使用来更有效率且精确地执行手术过程。
例如,美国专利No.5322055和No.5954736中公开的超声器械的例子和美国专利No.6309400B2、No.6278218B1、No.6283981B1和No.6325811B1中公开的超声刀和外科器械全部通过引用合并于此。这些参考文献公开了超声器械设计和刀设计,其中,刺激刀的纵向波节。由于一个或多个不对称性,这些刀会出现横向和/或扭转运动,此处,这种非纵向运动的特征“波长”小于刀及其延伸部分的整体纵向运动的特征“波长”。因此,非纵向运动的波形将沿着组织执行器出现横向/扭转运动的波节位置,而有源(active)刀沿着其组织执行器的净运动是非零的(即,沿着从其远端(纵向运动的波腹)延伸到纵向运动的第一波节位置(组织执行器部分的近侧)的长度将具有至少纵向运动)。现在将以实施例形式描述某些实施方式,以提供对这里描述的装置和方法的结构、功能、制造和使用的原理的整体理解。这些实施方式的一个或多个以说明性实施例形式示出在附图中。本领域普通技术人员将理解,这里具体描述和附图中示出的装置和方法是非限制性的示例性实施方式,因此各种实施方式的范围仅仅通过权利要求限定。结合一种示例性实施方式说明或描述的特征可以与其它实施方式的特征结合。这些修改和变型意在包含于本发明的范围内。
图1示出了超声系统10的一种实施方式。在所示的实施方式中,超声系统10包括与超声换能器14连接的超声信号发生器12、端部执行器50以及包括手持件壳体16的手持件组件60。端部执行器50可具有适于并能够切割骨组织的凿子状形状,可以具有适于并能够在骨组织中钻小孔的圆化端部,和/或可以被构造成切割、凝结和/或成形组织。被称作“Langevin stack”的超声换能器14通常包括换能部分18、第一共振器或者钟端部件(end-bell)20、和第二共振器或者钟前部件(fore-bell)22以及辅助部件。超声换能器14的长度优选为半系统波长的整数倍(nλ/2),如后面更详细地描述的。声学组件24包括超声换能器14、安装件26、速度转换器28和表面30。
将会理解,这里使用的术语“近侧”和“远侧”是以抓握手持件组件60的临床医生为参照的。因此,端部执行器50相对于更加近侧的手持件组件60处于远侧。还将理解,为了方便和清楚,这里使用的诸如“顶”和“底”等空间术语也是以抓握手持件组件60的临床医生为参照的。但是,外科器械用于多种方向和位置,因此这些术语并不是限制性和绝对的。
钟端部件20的远端连接到换能部分18的近端,而钟前部件22的近端连接到换能部分18的远端。钟前部件22和钟端部件20的长度由多个变量确定,包括换能部分18的厚度、用于制造钟端部件20和钟前部件22的材料的密度和弹性系数、以及超声换能器14的共振频率。钟前部件22可以从其近端向其远端向内逐渐变细以作为速度转换器28来放大超声振动振幅,或者替代地也可不具有放大。合适的振动频率范围可以是大约20Hz到120kHz,且非常合适的振动频率范围可以是大约30-70kHz,一种示例性的操作振动频率可以是大约55.5kHz。
压电元件32可由任何合适的材料构成,例如锆钛酸铅、偏铌酸铅、钛酸铅或者其它压电晶体材料。正电极34、负电极36和压电元件32的每一个具有延伸经过中心的钻孔。正电极34和负电极36分别电连接到导线38和40。导线38和40装在电缆42内并可电连接到超声系统10的超声信号发生器12。
声学组件24的超声换能器14将来自超声信号发生器12的电信号转换成机械能,以引起超声换能器14和端部执行器50以超声频率主要地纵向振动。一种合适的发生器可以是可从俄亥俄州辛辛那提的Ethicon Endo-surgery,Inc获得的型号为GEN04的发生器。当声学组件24被供能时,通过声学组件24可产生振动驻波。沿声学组件24的任意点处的振幅取决于沿声学组件24测量振动的位置。振动驻波的最小或者零交叉点通常称为波节(即,运动通常最小的位置),且驻波中绝对值最大或者峰处通常称为波腹(即,运动通常最大的位置)。波腹与其最近波节之间的距离为四分之一波长(λ/4)。
导线38和40将来自超声信号发生器12的电信号传输至正电极34和负电极36。压电元件32由响应于脚踏开关44的超声信号发生器12供应的电信号来供能,以在声学组件24中产生声学驻波。电信号在压电元件32中以反复小位移的形式造成扰动,导致材料内大的压力。这种反复小位移引起压电元件32沿着电压梯度的轴线以连续方式扩张和收缩,以产生纵向的超声能量波。超声能量通过声学组件24经由超声传输波导管46传输至端部执行器50。
为使声学组件24向端部执行器50传输能量,声学组件24的所有部件必须声学连接至端部执行器50。超声换能器14的远端可在表面30处通过例如柱头螺栓48的螺纹连接件声学连接至超声传输波导管46的近端。
优选对声学组件24的部件进行声学调节,使得任何组件的长度是半波长的整数倍(nλ/2),其中,波长λ为预先选择的或声学组件24的操作性纵向振动驱动频率fd的波长,n为任意正整数。还可以想到,声学组件24可含有任意合适的声学元件配置。
超声端部执行器50的长度可基本等于半系统波长(λ/2)的整数倍。超声端部执行器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,超声端部执行器50的远端52能够以预定的振动频率在例如大约10到500微米峰-峰值范围内、优选在大约30到150微米的范围内运动。
超声端部执行器50可连接到超声传输波导管46。示出的超声端部执行器50和超声传输波导管46为由适于传输超声能量的材料,例如Ti6Al4V(包括铝和钒的一种钛合金)、铝、不锈钢或者其它已知材料构成的单个单元。替代地,超声端部执行器50可与超声传输波导管分离(且构成不同)且例如通过柱头螺栓、焊接、胶接、快速连接或者其它合适的已知方法连接。超声传输波导管46的长度可例如基本等于半系统波长的整数倍(nλ/2)。超声传输波导管46可优选由实心轴构成,该实心轴由有效传播超声能量的材料,例如钛合金(即,Ti6Al4V)或者铝合金等材料制成。
超声传输波导管46包括位于近端的纵向突出的连接柱54,其通过例如柱头螺栓48的螺纹连接件连接到超声传输波导管的表面30。在所示的实施方式中,超声传输波导管46包括位于多个波节处的多个稳定硅环或者顺应性(compliant)支撑件或者硅环56。硅环56衰减不希望的振动并将超声能量与可拆卸的护套58隔离,从而确保超声能量以最大效率沿纵向流动到端部执行器50的远端52。
如图1所示,可拆卸的护套58连接到手持件组件60的远端。护套58总的包括适配器或者前锥体62和细长的管状构件64。管状构件64(例如,外管)连接到适配器62并具有纵向地延伸穿过其的开口。护套58可螺纹连接或者卡扣到壳体16的远端。超声传输波导46延伸穿过管状构件64的开口,且硅环56隔离内部的超声传输波导管46。
超声传输波导管46的远端可优选在波腹处或附近通过内螺纹连接件连接到端部执行器50的近端。可以想到,端部执行器50可通过例如焊接接头或类似物的任何合适手段连接到超声传输波导管46。尽管端部执行器50可从超声传输波导管46拆卸,但也可想到,端部执行器50的超声传输波导管46可作为单个一体件形成。
在一种实施方式中,超声手持件组件60的手持件壳体16能够接收或者适应例如槌击打或者手击打的机械冲击,并在手持件组件60处于有动力和无动力状态时将能量传递到端部执行器50中。在另一种实施方式中,手持件组件60可包括撞击板组件,例如以下描述的图10-13中的那些。因此,使用中临床医生可采用使用由换能部分18产生的超声振动而处于有动力状态的手持件60来利用凿子状端部执行器50切割和凝结较软的肌肉骨骼组织。在手持件组件60处于有动力和无动力状态时,临床医生可传递手动地或者采用骨凿槌对壳体16的远端的撞击,以凿进例如骨头的较硬的肌肉骨骼组织。
图2示出了用于超声器械的连接接合器/接头70的一种实施方式。在所示的实施方式中,连接接合器/接头70可形成在超声传输波导管46的连接柱54和位于声学组件24远端处的速度转换器28的表面30之间。连接柱54的近端包括具有内螺纹的大致圆柱形的凹陷66来在其内接收螺纹柱头螺栓48的一部分。速度转换器28的远端也可包括具有内螺纹的大致圆柱形的凹陷68来接收螺纹柱头螺栓48的一部分。凹陷66、68基本上沿周向和纵向对准。
图3示出了超声子组件118的一种实施方式,其能够连接到图1中描述的超声系统10的超声手持件组件60。在所示的实施方式中,超声子组件118能够连接到图1中描述的超声系统10的表面30。在一种实施方式中,超声子组件118包括护套或者外管150、超声传输波导管152、以及具有位于波腹处的远端52的端部执行器50。外管150具有纵向延伸穿过该外管的开口。超声传输波导管152包括远端122和近端124并限定纵向轴线“L”。近端124包括颈部或者过渡部分126以通过例如柱头螺栓、焊接、胶接或者其它已知的连接方法附接或者连接到手持件组件60的超声传输表面30。将会理解,颈部126的形状能够向表面30提供高效超声耦合。在所示的实施方式中,颈部126包括具有内螺纹的大致圆柱形的凹陷128来在其内接收螺纹柱头螺栓48的一部分。硅环56衰减不希望的振动并将超声能量与可拆卸的外管150隔离。近侧止挡140的凸缘与超声传输波导管152一体地形成并利用超声传输波导管152来调节,下文将进一步详细地解释。
尽管超声子组件118可如这里描述的超声连接到手持件组件60,但本领域普通技术人员将理解,这里公开的超声器械的各种实施方式及其任何等同结构是可以想到可有效地与其它已知的超声器械结合使用,也不脱离其范围。因此,这里公开的各种实施方式不应当局限于仅仅结合上述的示例性超声器械使用。
图4为超声器械120的一种实施方式的俯视透视图。图5为沿纵向轴线“L”截取的超声器械120的一种实施方式的剖视图。参照图4和图5,超声器械120包括图3中所示的超声子组件118。超声器械120包括超声传输波导管152、外管150和端部执行器50。超声器械120非常适于执行包括骨、肌肉、关节的肌肉骨骼组织以及诸如腱、韧带、软骨、关节和椎间盘等相关的关节周围组织。组织执行包括切割、凝结和钻孔。端部执行器50具有适于并能够切割骨组织的凿子状形状或者可以具有适于并能够在骨组织中钻出小孔的圆化端部。超声器械120适于以关于图3中的超声子组件118描述的方式连接到超声系统10的手持件组件60。在一种实施方式中,超声器械120利用例如柱头螺栓48的螺纹连接件或者通过焊接、胶接、快速连接或者其它合适的已知方法连接到手持件组件60。
超声器械120包括远端122和近端124并限定纵向轴线“L”。近端124包括从近端124突出的颈部或者过渡部分126。颈部126可通过例如柱头螺栓、焊接、胶接、快速连接或者其它合适的已知方法附接到超声传输表面30。近端124包括具有内螺纹的大致圆柱形的凹陷128来在其内接收螺纹柱头螺栓48的一部分。超声器械120超声连接到手持件组件60。
超声器械120包括“敲锤”部分130、握持部分132、以及纵向延伸的端部执行器部分134。敲锤部分130包括敲锤136,该敲锤136能够在近侧轴138之上沿箭头142指示的方向滑动到凸缘或近侧止挡140。握持部分132包括向远侧超过近侧止挡140设置定位在近侧套筒156(例如,轴衬)之上的把手148。超声传输波导管152的远侧部分位于延伸通过端部执行器部分134的外管150的纵向开口内侧。把手148通过环或者圆周突起154固定安装。圆周突起154可与超声传输波导管152的远侧部分一体形成或者可以固定安装到其上。
超声传输波导管152的远侧部分包括位于多个波节处的多个稳定硅环或者顺应性支撑件56。硅环56衰减不希望的振动并将超声能量与外管150隔离,确保超声能量以最大效率沿纵向流动到端部执行器50的远端52。
超声传输波导管152的过渡部分152、近侧轴138、近侧止挡140、以及远侧部分可作为单个一体件形成或者可以彼此可拆卸连接。超声传输波导管152的过渡部分152、近侧轴138、近侧止挡140、以及远侧部分形成可以调节和连接到手持件组件60的超声传输波导管,以如参照图1讨论地放大由超声换能器14产生的机械振动的振幅。可以调节超声器械120使得由超声振动引起的机械位移能够有效地从超声换能器14传递到端部执行器50,从而使执行器产生轴向纵向位移。
敲锤136能够在近侧轴138之上沿箭头142指示的方向滑动。敲锤136包括握持表面158和与端部执行器50成直线地轴向运动的滑动配重160。当敲锤136朝远端122轴向运动时,敲锤136的周向的远侧表面144冲击近侧止挡140的近侧表面146。近侧表面146限定接收机械冲击形式的振动能量的区域。造成的冲击通过超声传输波导管152传输以将远端122处的端部执行器50驱动到肌肉骨骼组织来实现治疗。滑动配重160在冲击时帮助传输能量。周向的近侧表面146形成冲击区。
使用中,临床医生可采用连接到超声器械120的超声手持件组件60来处置(effect)肌肉骨骼组织。在一个阶段,端部执行器50可以超声地操作(例如,有动力状态)。以此方式,临床医生一只手握持手持件组件60的手持件壳体16,并可以握持敲锤136或者把手148且采用基本由超声换能器14产生的能量用于组织处置。在另一阶段,临床医生可以一只手握持把手148并使敲锤136沿箭头142指示的方向轴向运动,以使配重敲锤136的远侧表面144撞击在近侧止挡140的近侧表面146。这种动作给端部执行器50以驱动力或能量。敲锤136可在或不在超声振动的帮助下手动操作。例如,在超声手持件组件60处于有动力和无动力状态时都可采用敲锤136。
图6为沿纵向轴线“L”截取的振动外科器械170的一种实施方式的剖视图。在所示的实施方式中,振动外科器械170包括端部执行器50,该端部执行器50非常适用于处置(例如,切割、凝结、钻孔)包括骨、肌肉、关节的肌肉骨骼组织以及诸如腱、韧带、软骨、关节和椎间盘等相关的关节周围组织。如前已述及的,端部执行器50可具有适于并能够切割骨组织的凿子状形状或者可以具有适于并能够在骨组织中钻出小孔的圆化端部。振动外科器械170包括远端122和近端124并限定纵向轴线“L”。
近端124包括手持件组件172。壳体188包含发生器174以驱动包括凸角178的旋转凸轮176。在所示的实施方式中,手持件组件172并不包括压电换能器来产生超声振动。在不使用压电换能器的情况下,发生器174通过机械动作产生纵向振动位移。在一种实施方式中,通过围绕轴心175驱动凸轮176,发生器174产生各种预定频率的纵向机械振动。凸角178可被构造为旋转凸轮176的任何合适突出部分,以在其圆形路径上的一个或者多个点处撞击或者与振动传输波导管182的表面180机械连接。表面180具有能够接受机械撞击形式的振动能量的区域。凸角178将振动能量传递到振动传输波导管182中。振动传输波导管182用作随动器。这在借助表面180与凸角178接触的振动传输波导管182中产生平滑的轴向振荡。凸角178可以是简单的圆化的光滑突起,以将动力脉冲传递到振动传输波导管182的表面180。在替代实施方式中,凸角178可以是偏心盘或者在振动传输波导管182随动器中产生平滑振荡的其他形状,该随动器为与凸角178接触的杆。因此,凸角178将凸轮176的圆形运动转换成形成纵向振荡或振动的线性位移,这种线性位移通过振动传输波导管182高效地传输至端部执行器50的远端52。相应地,端部执行器50的远端52经历纵向位移以处置组织。发生器174可采用电马达、液压马达或者气动马达来围绕轴心175驱动凸轮176。本领域普通技术人员将理解,液压马达使用高压水流来使连接到凸轮176的轴围绕轴心175旋转。
振动传输波导管182可位于套筒186之上的手柄部分或者把手184内侧。振动传输波导管182可限制在把手48内并可通过环或者圆周突起190固定安装。圆周突起190可与振动传输波导管182的远侧部分一体形成或者固定安装到其上。原则上,振动传输波导管182以与图1中讨论的超声传输波导管46类似的方式操作。但是,可调节振动传输波导管182来放大和传输利用旋转凸轮176和凸角178配置适当地或者可实际实现的频率的纵向振动。不管怎样,可以想到,振动传输波导管182可以超声频率驱动。如前已述及的,合适的振动频率范围可以是大约20Hz到120kHz,且非常合适的振动频率范围可以是大约30-70kHz,一种示例性的操作振动频率可以是大约55.5kHz。
振动传输波导管182位于通过外管150限定的纵向开口内。振动传输波导管182包括位于多个波节处的多个稳定硅环或者顺应性支撑件56。硅环56衰减不希望的振动并将超声能量与外管150隔离,从而确保超声能量以最大效率沿纵向流动到端部执行器50的远端52。
使用中,临床医生可采用振动外科器械170来处置肌肉骨骼组织。端部执行器50被定位在患者体内希望的组织治疗区域。临床医生握持把手48部分并操纵端部执行器50来处置肌肉骨骼组织。由旋转凸轮176和凸角178配置产生的振动通过振动传输波导管182被有效地传递至端部执行器50的远端52。相应地,端部执行器50的远端52经历纵向位移以帮助执行切割、凝结、钻孔组织。因此,振动外科器械170能够使临床医生对肌肉骨骼组织执行组织处置,其精确性高于单独利用敲锤或者使用骨凿(例如,骨凿子)和槌所能够实现的。骨凿是用于切割或标记骨的楔形器械,通常被称为凿子且由临床医生和槌一起来使用。
图7是沿纵向轴向“L”截取的振动外科器械200的一种实施方式的剖视图。在所示的实施方式中,振动外科器械200包括端部执行器50,该端部执行器50非常适用于处置(例如,切割、凝结、钻孔)包括骨、肌肉、关节的肌肉骨骼组织以及诸如腱、韧带、软骨、关节和椎间盘等相关的关节周围组织。如前已述及的,端部执行器50可具有适于并能够切割骨组织的凿子状形状或者可以具有适于并能够在骨组织中钻出小孔的圆化端部。振动外科器械200包括远端122和近端124并限定纵向轴线“L”。
振动外科器械200在近端124处包括凸缘或者撞击板202。撞击板202限定可撞击表面203,该可撞击表面203具有能够接收例如来自骨凿式槌204的槌击打的机械撞击形式的振动能量的凸缘区域,并将产生的振动能量传输至端部执行器50内。利用槌204击打撞击板202产生合适的共振,共振可以维持一段时间以与机械振动机械一致地使端部执行器50机械偏移。振动外科器械200包括位于外部管状构件或者外管150内的振动传输波导管206。振动传输波导管206的远侧部分包括位于多个波节处的多个稳定硅环或者顺应性支撑件56。硅环56衰减不希望的振动并将超声能量与可拆卸护套150隔离,确保超声能量以最大效率沿纵向流动到端部执行器50的远端52。
振动传输波导管206可位于套筒186(例如,轴衬)之上的手柄部分或者把手208内侧。振动传输波导管206可限制在把手208内并可通过环或者圆周突起212固定安装。圆周突起212可与振动传输波导管206的远侧部分一体形成或者固定安装到其上。原则上,振动传输波导管206以与图1中讨论的超声传输波导管46类似的方式操作。但是,可调节振动传输波导管206来放大和传输利用骨凿式槌204击打撞击板202的可撞击表面204可更适当地实现的频率的纵向振动。
使用中,临床医生可采用振动外科器械200来处置肌肉骨骼组织。端部执行器50被定位在患者体内希望的组织治疗区域。临床医生一只手握持把手208部分并操纵端部执行器50来治疗肌肉骨骼组织。由击打撞击板202产生的振动被有效地传递至端部执行器50的远端52。端部执行器50的远端52经历纵向位移以帮助执行切割、凝结、钻孔组织。因此,振动外科器械200能够使临床医生对肌肉骨骼组织执行组织处置,其精确性高于单独利用敲锤或者使用骨凿子或者调节的骨凿所能够实现的。
图8是沿纵向轴向“L”截取的超声器械240的一种实施方式的剖视图。在所示的实施方式中,超声器械240包括端部执行器50,该端部执行器50非常适用于处置(例如,切割、凝结、钻孔)包括骨、肌肉、关节的肌肉骨骼组织以及诸如腱、韧带、软骨、关节和椎间盘等相关的关节周围组织。如前已述及的,端部执行器50可具有适于并能够切割骨组织的凿子状形状或者可以具有适于并能够在骨组织中钻出小孔的圆化端部。超声器械240包括远端122和近端124并限定纵向轴线“L”。超声器械240可以被用来作为超声骨锤来帮助将切割器械和例如“检验(trial)”装置的硬件驱动到例如骨头的肌肉骨骼组织中。但在多种其它的实施方式中,超声器械240可以与包括用于切割、凝结和/或再成形组织的传统超声刀的超声端部执行器50结合采用。在图8所示的实施方式中,可采用超声器械240来将端部执行器50驱动到组织或者用力牵拉,例如分离肢的骨片段或者关节表面,也可以采用超声器械240来去除紧密楔入的器械。超声器械240增加了手术过程中的效率和速度,同时提供了比手动操作的骨凿更大的精确性。
超声器械240在近端124处包括超声滑锤242。超声滑锤242可在第一凸缘或近侧止挡246和第二凸缘或远侧止挡248之间沿箭头290、292指示的方向在近侧轴244之上滑动。超声滑锤242包括被称作“Langevin stack”的超声换能器250并总的包括换能部分252、第一共振器或者钟端部件254、和第二共振器或者钟前部件256以及辅助部件。在所示的实施方式中,超声换能器250是超声滑锤242的运动块。如前面参照图1中的超声系统10讨论的,超声换能器250的长度优选为半系统波长的整数倍(nλ/2)。声学组件251由超声换能器250、近侧轴244、近侧止挡246和远侧止挡248形成。在所示的实施方式中,超声换能器250的长度为λ/2且近侧轴244的长度至少为所示的1λ,大体上标示在“A”处的波腹(例如,轴向偏移通常最大)形成在近侧轴244的远端和近端。近侧轴244可以更长。不论如何,近侧轴244的长度应当是半波长的整数倍(nλ/2)且应当比超声换能器250至少长半个波长(λ/2)。超声器械240从近侧轴244的远端至端部执行器50的远端52的长度应当为半系统波长的整数倍(nλ/2)。以下更加详细地解释这些关系。
钟端部件254的远端连接到换能部分252的近端,而钟前部件256的近端连接到换能部分252的远端。钟前部件256和钟端部件254的长度由多个变量确定,包括换能部分252的厚度、用于制造钟端部件254和钟前部件256的材料的密度和弹性系数,以及超声换能器250的共振频率。超声换能器250产生超声频率的冲击或者振动并给予耦合到超声传输波导管262的应力波以推进(例如,驱动)或者去除(例如,收回)超声器械240。当其被驱动或者连接到由远侧止挡248的近侧表面形成的远侧撞击压盘258时,钟前部件256的远侧表面用作驱动压盘288。远侧撞击压盘258的表面具有能够接收振动形式的振动能量并将振动能量传递至端部执行器50的区域。驱动压盘288的表面位于波腹“A”处。当驱动压盘288连接到远侧撞击压盘258时,由超声换能器250产生的超声振动通过超声传输波导管262耦合并形成冲击以沿着箭头290指示的方向将超声器械240驱动到远端122处的组织中。当其被驱动并连接至由近侧止挡246的远侧表面形成的近侧撞击压盘260时,钟端部件254的近侧表面用作去除压盘286。近侧撞击压盘260的表面具有能够接收振动形式的振动能量并将振动能量传递至近测止挡246的区域。去除压盘286的表面位于波腹“A”处。当去除压盘286连接到近侧撞击压盘260时,由超声换能器250产生的超声振动耦合到近侧止挡246中并产生冲击以沿箭头292指示的方向将近侧方向中的超声换能器250从组织收回。用于超声滑锤242的合适的振动频率范围可以是大约20Hz到120kHz,且非常合适的振动频率范围可以是大约30-70kHz,一种示例性的操作振动频率可以是大约55.5kHz。一般规则是,低频率倾向于提供更多的功率能力。在一种实施方式中,超声换能器250并不连接到端部执行器50,而是形成振动的“手提钻(jackhammer)”。
压电元件264可由任何合适的材料构成,例如锆钛酸铅、偏铌酸铅、钛酸铅或者其它压电晶体材料。正电极266、负电极268和压电元件264的每一个具有延伸经过中心的钻孔。正电极266和负电极268分别电连接到导线272和270。导线270和272装在电缆274内并可电连接到超声信号发生器276。
超声换能器250将来自超声信号发生器276的电信号转换成机械能,以引起超声换能器250和端部执行器50以超声频率主要地纵向振动。一种合适的发生器可以是可从俄亥俄州辛辛那提的Ethicon Endo-surgery,Inc商业获得的型号为GEN04的发生器。当声学组件251被激励时,通过声学组件251可产生振动驻波。沿声学组件251的任意点处的振动振幅取决于沿声学组件251测量振动的位置。振动驻波的最小或者零交叉点通常称为波节(即,运动通常最小的位置),且驻波中绝对值最大或者峰处通常称为波腹(即,运动通常最大的位置)。波腹与其最近波节之间的距离为四分之一波长(λ/4)。
导线270和272将来自超声信号发生器276的电信号传输至各自的正电极268和负电极266。压电元件264由响应于脚踏开关278的超声信号发生器264供应的电信号来激励,以在声学组件251中产生声学驻波。电信号在压电元件264中以反复小位移的形式造成扰动,导致材料内大的压力。这种反复小位移引起压电元件264沿着电压梯度的轴线以连续方式扩张和收缩,以产生纵向的超声能量波。超声能量通过声学组件251经由超声传输波导管262传输至端部执行器50。为使声学组件251向端部执行器50传输能量,声学组件251的所有部件必须声学连接至端部执行器50。在一种操作模式中,超声换能器250的远端52可声学连接至远侧止挡248的近侧表面258和超声传输波导管262。在另一种操作模式中,超声换能器250的近端可通过近测轴244声学连接至近侧止挡246的远侧表面260和超声传输波导管262。
优选对声学组件251的部件进行声学调节,使得任何组件的长度是半波长的整数倍(nλ/2),其中,波长λ为预先选择的或声学组件251的操作性纵向振动驱动频率fd的波长,n为任意正整数。还可以想到,声学组件251可含有任意合适的声学元件配置。
超声端部执行器50的长度可基本等于半系统波长(λ/2)的整数倍。超声端部执行器50的远端52可设置在波腹“A”附近,以提供远端52的最大纵向偏移。当超声换能器250通电且振动经由超声传输波导管262耦合到端部执行器50时,超声端部执行器50的远端52能够以预定的振动频率在例如大约10到500微米峰-峰值范围内、优选在大约30到150微米的范围内运动。
超声端部执行器50可连接到超声传输波导管262。在所示的实施方式中,超声端部执行器50、超声传输波导管262、近侧止挡246和远侧止挡248以及近侧轴244作为单个单元结构,由适于传输超超声能量的材料,例如Ti6Al4V(包括铝和钒的一种钛合金)、铝、不锈钢或者其它已知材料构形成。替代地,超声端部执行器50可与超声传输波导管262分离(且构成不同)且例如通过柱头螺栓、焊接、胶接、快速连接或者其它合适的已知方法连接。超声传输波导管262的长度可例如基本等于半系统波长的整数倍(nλ/2)。超声传输波导管262可优选由实心轴构成,该实心轴由有效传播超声能量的材料,例如钛合金(即,Ti6Al4V)或者铝合金等材料制成。在所示的实施方式中,超声传输波导管262包括位于多个波节处的多个稳定硅环或者顺应性支撑件56。硅环56衰减不希望的振动并将超声能量与外管150隔离,从而确保超声能量以最大效率沿纵向“L”轴向流动到端部执行器50的远端52。
在替代实施方式中,远侧止挡248的远端可构造有例如螺纹连接件的连接特征,以利用柱头螺栓连接到超声传输波导管262或者其它超声(例如,整形)器械。在其它实施方式中,远侧止挡248的远端可构造有纵向突出的连接柱,以连接到超声传输波导管262或者其它超声器械。在其它实施方式中,超声传输波导管262或者其它超声器械可通过柱头螺栓焊接、胶接、快速连接或者其它合适的已知方法连接到远侧止挡248的远端。
使用中,临床医生可操作驱动模式和收回模式的超声器械240。在所示的实施方式中,超声滑锤242构造有用于临床医生拿持的圆柱形把手294。在驱动模式,超声滑锤242沿箭头290指示的方向运动,以将超声器械240驱动到组织中。在收回模式中,超声滑锤242沿箭头292指示的方向收回超声器械240。在替代实施方式中,超声滑锤242构造有手枪状把手,从而临床医生能够更像例如动力钻地拿持超声滑锤242。当驱动压盘288被沿箭头290指示的方向推动到远侧撞击压盘258时,超声换能器250产生冲击,该冲击通过超声传输波导管耦合至端部执行器50,从而将驻波传递到待治疗的组织中。由于驱动压盘288和远侧撞击压盘258都位于波腹“A”处,因此,临床医生只需要施加足够的载荷将驱动压盘288与远侧撞击压盘258一起推动。在波腹“A”处基本上没有振动应力,因此最小的振动传递给临床医生的手。临床医生施加力直到实现希望的效果。
超声器械可以包括在近侧套筒282之上超出近侧止挡248远侧定位的任选把手280。把手280通过环或者圆周突起284固定安装。圆周突起284可与超声传输波导管262的远侧部分一体形成或者可以固定安装到其上。把手280设有用于临床医生在手术过程中拿持以帮助支撑和引导超声器械240的另外的手柄。
图9是沿纵向轴向“L”截取的超声器械300的一种实施方式的剖视图。在所示的实施方式中,超声器械300包括端部执行器50,该端部执行器50非常适用于处置(例如,切割、凝结、钻孔)包括骨、肌肉、关节的肌肉骨骼组织以及诸如腱、韧带、软骨、关节和椎间盘等相关的关节周围组织,如前所述。超声器械300包括远端122和近端124并限定纵向轴线“L”。超声器械300可以被用来作为超声骨锤来帮助将切割器械和例如“检验”装置的硬件驱动到例如骨头的肌肉骨骼组织中。可采用超声器械300来将器械驱动到组织或者用力牵拉,也可以采用超声器械300来去除紧密楔入的器械。超声器械300增加了手术过程中的效率和速度,同时提供了比手动操作的骨凿更大的精确性。
超声器械300在近端124处包括基本如参照图8描述的超声滑锤242。超声滑锤242可在第一凸缘或近侧止挡246和第二凸缘或远侧止挡302之间沿箭头290、292指示的方向在近侧轴244之上滑动。在所示的实施方式中,远侧止挡302具有大致截头圆锥的形状并从近端到远端向内逐渐变细,以放大超声换能器250产生的超声振动振幅。如图9中示出的实施方式所示,圆锥过渡发生在波节“N”处。超声滑锤242包括超声换能器250,如前面参照图8所讨论的。在所示的实施方式中,超声换能器250的长度优选为半系统波长的整数倍(nλ/2),如前面参照图1中的超声系统10所讨论的。声学组件306由超声换能器250、近侧轴244、和近侧止挡246或远侧止挡302的任一形成。在所示的实施方式中,超声换能器250的长度为λ/2且近侧轴的长度为λ,大体在“A”处(例如,轴向位移通常最大处)标示的波腹形成在近侧轴244的远端和近端。超声器械300从近侧轴244的远端到端部执行器50的远端52的长度应当为半系统波长的整数倍(nλ/2)。上面参照图8详细地解释了这些关系。
如前所述,超声换能器250产生超声频率的冲击或者振动并传递耦合到超声传输波导管304的应力波以推进(例如,驱动)或者去除(例如,收回)超声器械300。当超声滑锤242沿箭头290指示的方向运动时,远侧驱动压盘288被驱动或连接到由近侧止挡302的近侧表面形成的远侧撞击压盘248。驱动压盘288的表面位于波腹“A”处。当驱动压盘288连接到远侧撞击压盘258时,由超声换能器250产生的超声振动通过超声传输波导管304耦合并形成冲击以沿着箭头290指示的方向将超声器械300驱动到远端122处的组织中。当超声滑锤242沿箭头292指示的方向运动时,近侧去除压盘286被驱动或连接到由近侧止挡246的远侧表面形成的近侧撞击压盘260。去除压盘286的表面位于波腹“A”处。当去除压盘286连接到近侧撞击压盘260时,由超声换能器250产生的超声振动耦合到近侧止挡246中并产生冲击以沿箭头292指示的方向将近侧方向中的超声器械300从组织收回。如前已述及的,远侧止挡302放大由超声换能器250产生的超声振动的振幅。用于超声滑锤242的合适的振动频率范围可以是大约20Hz到120kHz,且非常合适的振动频率范围可以是大约30-70kHz,一种示例性的操作振动频率可以是大约55.5kHz。一般规则是,低频率倾向于提供更多的功率能力。
超声换能器250将来自超声信号发生器276的电信号转换成机械能,以引起超声换能器250和端部执行器50以超声频率主要地纵向振动。当声学组件306被激励时,通过声学组件306可产生振动驻波。沿声学组件306的任意点处的振动振幅取决于沿声学组件306测量振动的位置。振动驻波的最小或者零交叉点通常称为波节(即,运动通常最小的位置),且驻波中绝对值最大或者峰处通常称为波腹(即,运动通常最大的位置)。波腹与其最近波节之间的距离为四分之一波长(λ/4)。
超声换能器250由响应于脚踏开关278的超声信号发生器264供应的电信号来激励,以在声学组件306中产生声学驻波。超声能量经由超声传输波导管304通过声学组件306传输至端部执行器50。为使声学组件306向端部执行器50传输能量,声学组件306的所有部件必须声学连接至端部执行器50。在一种操作模式中,超声换能器250的远端可声学连接至远侧撞击压盘258,由远侧止挡302元件放大,并连接至超声传输波导管304。在另一种操作模式中,超声换能器250的近端可通过超声传输波导管304和近侧轴244声学连接至近侧撞击压盘260。
优选对声学组件306的部件进行声学调节,使得任何组件的长度是半波长的整数倍(nλ/2),其中,波长λ为预先选择或声学组件306的操作性纵向振动驱动频率fd的波长,n为任意正整数。还可以想到,声学组件306可含有任意合适的声学元件配置。
超声端部执行器50的长度可基本等于半系统波长(λ/2)的整数倍。超声端部执行器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。当超声换能器250通电且振动经由超声传输波导管262耦合到端部执行器50时,超声端部执行器50的远端52能够以预定的振动频率在例如大约10到500微米峰-峰值范围内、优选在大约30到150微米的范围内运动。
超声端部执行器50可连接到超声传输波导管304。在所示的实施方式中,超声端部执行器50、超声传输波导管304、近侧止挡246和远侧止挡302以及近侧轴244作为单个单元结构,由适于传输超超声能量的材料,例如Ti6Al4V(包括铝和钒的一种钛合金)、铝、不锈钢或者其它已知材料构形成。替代地,超声端部执行器50可与超声传输波导管304分离(且构成不同)且例如通过柱头螺栓、焊接、胶接、快速连接或者其它合适的已知方法连接。超声传输波导管304的长度可例如基本等于半系统波长的整数倍(nλ/2)。超声传输波导管304可优选由实心轴构成,该实心轴由有效传播超声能量的材料,例如钛合金(即,Ti6Al4V)或者铝合金等材料制成。在所示的实施方式中,超声传输波导管304包括位于多个波节处的多个稳定硅环或者顺应性支撑件56。硅环56衰减不希望的振动并将超声能量与可拆卸的护套或者外管150隔离,从而确保超声能量以最大效率沿纵向“L”轴向流动到端部执行器50的远端52。
在替代实施方式中,远侧止挡302的远端可构造有例如螺纹连接件的连接特征,以利用柱头螺栓连接到超声传输波导管304或者其它超声(例如,整形)器械。在其它实施方式中,远侧止挡302的远端可构造有纵向突出的连接柱,以连接到超声传输波导管304或者其它超声器械。在其它实施方式中,超声传输波导管304或者其它超声器械可通过焊接、胶接、快速连接或者其它合适的已知方法连接到远侧止挡302的远端。
使用中,临床医生可以前面参照图8描述的基本类似的方式操作超声器械300。在所示的实施方式中,超声滑锤242构造有圆柱形把手294,使得临床医生可拿持超声滑锤242同时运动它。为驱动超声器械300,临床医生使超声滑锤242沿箭头290指示的方向运动。为收回超声器械300,临床医生使超声滑锤242沿箭头292指示的方向运动。在替代实施方式中,超声滑锤242构造有手枪状把手,从而临床医生能够更像例如动力钻地拿持超声滑锤242。当驱动压盘288被沿箭头290指示的方向推动到远侧撞击压盘258时,超声换能器250产生冲击,该冲击通过超声传输波导管耦合至端部执行器50,从而将应力波传递到正在治疗的组织中。由于驱动压盘288和远侧撞击压盘258都位于波腹“A”处,因此,临床医生只需要施加足够的载荷一起迫使驱动压盘288进入远侧撞击压盘258。在波腹“A”处基本上没有振动应力,因此最小的振动传递给临床医生的手。临床医生施加力直到实现希望的效果。
参照图8和图9中所示的超声器械240、300,为驱动到组织中,端部执行器50的远端52必须克服组织的失效限制。在简单模式中,这表示为组织反作用力并是在端部执行器50的远端52处垂直作用于组织(例如,骨)以穿透组织所需的力的度量。组织表面处所需要的用来克服组织的失效限制的超声力可以简单形式表示为组织反作用力Ft:
Ft=k·x+c·x+d·x2
其中
k=组织的弹性系数;
c=组织的摩擦系数;且
d=组织的水力阻力系数。
图10示出了包括冲击区域的超声器械310的一种实施方式的侧视图。在所示的实施方式中,超声器械310沿着轴线“L”在远端124和近端122之间纵向延伸。在一种实施方式中,超声器械310包括超声手持件组件312。在超声方面,手持件组件312基本类似于图1中描述的超声手持件组件60并以与其基本相同的方式操作。如前面参照图1讨论的,超声器械310包括壳体314、换能部分18和声学组件24部分。在一种实施方式中,壳体314包括基本圆形的横截面(未示出)。超声器械310包括外部护套58,该外部护套含有连接到端部执行器50的超声传输波导管46(如前面图1中讨论的)。在所示的实施方式中,端部执行器50具有凿子形。电缆42将超声手持件组件312连接到超声发生器(例如,图1中所示的超声发生器12)。
在一种实施方式中,超声器械310包括撞击板组件316。撞击板组件316包括凸缘或者撞击板308。撞击板308限定可撞击表面320,该可撞击表面320具有凸缘区域,该凸缘区域能够在手持件组件312处于有动力或者无动力状态时接收或适应机械冲击,并将能量传输至端部执行器50内。机械冲击或者撞击可例如手动地或者利用骨锤传递。撞击板318适于在可撞击表面320处接收来自骨锤(例如,类似于图7中所示的锤子204)通常的击打或者撞击,而不损害超声手持件组件312。在所示的实施方式中,撞击板组件316包括在近端刚性地连接到撞击板318和在远端固定连接到壳体314的多个纵向延伸的细长支撑构件322。在一种实施方式中,壳体14和撞击板组件318可作为单个一体件形成。在替代的实施方式中,壳体314和撞击板组件318可例如通过柱头螺栓、焊接、胶接、快速连接或者其它合适的已知方法附装、连接或者接合。
使用中,临床医生可采用处于使用由换能部分18产生的超声振动的有动力状态的超声器械310,来利用凿子形的端部执行器50切割和凝结较软的肌肉骨骼组织。在超声器械310处于有动力和无动力状态时,临床医生可采用骨凿来击打可撞击表面320,以凿例如骨头的较硬的肌肉骨骼组织。
图11示出了包括冲击区域的超声器械330的一种实施方式的侧视图。在所示的实施方式中,超声器械330沿着轴线“L”在远端124和近端122之间纵向延伸。在一种实施方式中,超声器械330包括超声手持件组件332。在超声方面,手持件组件332基本类似于图1中描述的超声手持件组件60并以与其基本相同的方式操作。如前面参照图1讨论的,超声器械330包括壳体334、换能部分18和声学组件24部分。在一种实施方式中,壳体334包括基本圆形的横截面(未示出)。超声器械330包括护套58,该护套含有连接到端部执行器50的超声传输波导管46(如前面图1中讨论的)。在所示的实施方式中,端部执行器50具有凿子形。电缆42将超声手持件组件332连接到超声发生器(例如,图1中所示的超声发生器12)。
在一种实施方式中,超声器械330包括撞击板组件336。撞击板组件336包括凸缘或者撞击板338。撞击板338限定可撞击表面340,该可撞击表面340具有凸缘区域,该凸缘区域能够在手持件组件332处于有动力或无动力状态时接收或适应机械冲击,并将能量传输至端部执行器50内。机械冲击或者撞击可例如手动地或者利用骨锤传递。撞击板338适于在可撞击表面330处接收来自骨锤(例如,类似于图7中所示的锤子204)通常的击打或者撞击,而不损害超声手持件组件332。在所示的实施方式中,撞击板组件336包括一个或多个纵向延伸的细长支撑构件342和横向压缩构件344,以将撞击板组件336可拆卸连接至壳体334。在一种实施方式中,横向压缩构件344可构造为径向地组装的“C”或者“U”形压缩构件。通过沿箭头350指示的方向滑动地压迫横向压缩构件344来接合并压缩形成在壳体334上的槽346,横向压缩构件344可径向地组装到槽346。横向压缩构件344可通过沿箭头348的方向施加力而径向去除。在接合时,横向压缩构件344能够利用适于抵抗向着可撞击表面340撞击的力压迫槽。在一种实施方式中,槽346可以是基本围绕壳体334的圆周部分或者圆形截面部分延伸的槽。
如前面参照图10所讨论的,在使用时,临床医生可采用处于使用由换能部分18产生的超声振动的有动力状态的超声器械330,来利用凿子形的端部执行器50切割和凝结较软的肌肉骨骼组织。在超声器械330处于有动力或无动力状态时,临床医生可采用骨凿来击打可撞击表面340,以凿例如骨头的较硬的肌肉骨骼组织。
图12示出了包括冲击区域的超声器械360的一种实施方式的侧视图。在所示的实施方式中,超声器械360沿着轴线“L”在远端124和近端122之间纵向延伸。在一种实施方式中,超声器械360包括超声手持件组件362。在超声方面,手持件组件362基本类似于图1中描述的超声手持件组件60并以与其基本相同的方式操作。如前面参照图1讨论的,超声器械360包括壳体364、换能部分18和声学组件24部分。在一种实施方式中,壳体364包括基本圆形的横截面(未示出)。超声器械360包括护套58,该护套中含有连接到端部执行器50的超声传输波导管46(如前面图1中讨论的)。在所示的实施方式中,端部执行器50具有凿子形。电缆42将超声手持件组件362连接到超声发生器(例如,图1中所示的超声发生器12)。
在一种实施方式中,超声器械360包括撞击板组件366。撞击板组件366包括凸缘或者撞击板368。撞击板368限定可撞击表面370,该可撞击表面370具有凸缘区域,该凸缘区域能够在手持件组件362处于被有动力或者无动力状态时接收或适应机械冲击,并将能量传输至端部执行器50内。机械冲击或者撞击可例如手动地或者利用骨锤传递。撞击板368适于在可撞击表面330处接收来自骨锤(例如,类似于图7中所示的锤子204)通常的击打或者撞击,而不损害超声手持件组件362。在所示的实施方式中,撞击板组件366包括一个或多个纵向延伸的细长支撑构件372和螺纹连接件375。螺纹连接件375由内部的内螺纹部分374形成以接合围绕壳体364的圆形横截面部分周向形成的相应外部的外螺纹部分376。通过将内螺纹部分374旋到外螺纹部分376上,撞击板组件366可与壳体364接合。止挡378刚性附装到壳体364上或者与其一体形成,以接触支撑构件372的远侧壁部分380。撞击板368包括从近端纵向延伸到远端的套筒382。套筒382在远端处包括凸缘390以接合定位在套筒382内的压缩弹簧元件384。支撑构件372的近端386包括形成用来接合压缩弹簧元件384的近端的凸缘388。压缩弹簧元件384围绕支撑构件384的近端386设置。撞击板368的近端还包括球394和能够接合并压缩球394的表面以将撞击板368保持就位的压缩弹簧元件396。
如前面参照图10和11所讨论的,在使用时,临床医生可采用处于使用由换能部分18产生的超声振动的有动力状态的超声器械360,来利用凿子形的端部执行器50切割和凝结较软的肌肉骨骼组织。在超声器械360处于有动力或无动力状态时,临床医生可采用骨凿来击打可撞击表面370,以凿进例如骨头的较硬的肌肉骨骼组织。
图13示出了包括冲击区域的超声器械400的一种实施方式的侧视图。在所示的实施方式中,超声器械400沿着轴线“L”在远端124和近端122之间纵向延伸。在一种实施方式中,超声器械400包括超声手持件组件402。在超声方面,手持件组件402基本类似于图1中描述的超声手持件组件60并以与其基本相同的方式操作。如前面参照图1讨论的,超声器械400包括壳体404、换能部分18和声学组件24部分。在一种实施方式中,壳体404包括基本圆形的横截面(未示出)。超声器械400包括护套58,该护套中含有连接到端部执行器50的超声传输波导管46(如前面图1中讨论的)。在所示的实施方式中,端部执行器50具有凿子形。电缆42将超声手持件组件402连接到超声发生器(例如,图1中所示的超声发生器12)。
在一种实施方式中,超声器械400包括撞击板组件406。撞击板组件406包括凸缘或者撞击板408。撞击板408限定可撞击表面410,该可撞击表面410具有凸缘区域,该凸缘区域能够接收来自滑(击)锤414的击打。滑锤414具有纵向延伸穿过其的开口。滑锤414在远端处包括适于传递击打至可撞击表面410或者击打可撞击表面410。在手持件组件处于有动力和无动力状态时,来自滑锤414的击打将能量传递到端部执行器50中。撞击板408适于在可撞击表面410处接收来自滑锤414通常的击打或者撞击,而不损害超声手持件组件402。在所示的实施方式中,撞击板组件406包括刚性地连接到壳体404的一个或多个纵向延伸的细长支撑构件412。撞击板408形成有从远端突出到近端的轴416。轴416的近端包括凸缘418。滑(击)锤414能够沿箭头420指示的方向在轴416上轴向滑动。
如前面参照图10-12所讨论的,在使用时,临床医生可采用处于使用由换能部分18产生的超声振动的有动力状态的超声器械400,来利用凿子形的端部执行器50切割和凝结较软的肌肉骨骼组织。在超声器械400处于有动力和无动力状态时,临床医生可手动地击打可撞击表面410或采用骨凿以凿例如骨头的较硬的肌肉骨骼组织。
图14-17示出了在远端122处包括端部执行器452的超声器械450的一种实施方式。超声器械450沿着轴线“L”在远端124和近端122之间纵向延伸。端部执行器452包括不振动夹钳454和超声刀456。在图14-17所示的实施方式中,夹钳454枢转地安装到枢转点472并可如箭头458所示从远端旋转至近端到达打开的折回位置,该打开的折叠位置暴露出超声刀456,用来再成形和凝结组织。夹钳454可旋转大约180°,使得在处于打开或者关闭位置处时,夹钳454与纵向轴线基本对准以与纵向轴线成直线或者平行。夹钳454能够如箭头459所示从远端旋转至近端到达闭合位置,用于将刀456和夹钳454之间的组织挤压在刀456的一侧,以使用振动的剪切作用增强组织切割/凝结效果。图14是夹钳454处于闭合位置的超声器械450的一种实施方式的侧视透视图。图15和16是夹钳454处于部分打开位置的超声器械450的一种实施方式的侧视透视图。图17是夹紧臂组件处于闭合位置的超声器械450的侧视透视图。
现在参照图14-17,超声器械450包括超声手持件组件464。在超声方面,手持件组件402基本类似于图1中描述的超声手持件组件60并以与其基本相同的方式操作。相应地,如前面参照图1讨论的,超声手持件组件464也包括换能部分18和声学组件24。超声器械450包括从手持件组件464延伸到端部执行器454的近端的外部管状构件或者外管462。外管462具有大致圆形的横截面和纵向开口或孔466,以接收在收回或者折回位置的夹钳454。内部致动器管状构件或者内管468在外管462内纵向延伸。内管468具有纵向延伸穿过其的开口。外管462和内管468可由不锈钢构成。将会认识到,外管462可由任何合适材料构成且可具有任何合适的横截面形状。端部执行器452能够执行各种任务,例如抓取组织、切割组织等。可以想到,端部执行器452可以任何合适的结构形成。
如前已述及的,端部执行器452包括不振动夹钳354和超声刀456。夹紧臂组件454的组织接合部分包括夹紧垫470。例如,不振动夹钳454用来抓住组织或者向着超声刀456压迫组织。
超声刀456可包括凿子形状并适于切割和凝结较软的肌肉骨骼组织和凿或者钻较硬的例如骨骼的肌肉骨骼组织。不管如何,超声刀456可采用在多种其它治疗手术中。在一种实施方式中,超声刀456包括位于远侧部分的切割凿刃。超声刀456连接到位于外管462内的超声传输波导管。
夹钳454优选在枢转点472处枢转地安装接到外管462的远端,使得夹钳454能够沿箭头458、459所示的弧形方向旋转。枢销474插过枢转点472。外管462的远端包括限定接收枢销474的相应孔478A和478B(未示出)的突起476A和476B。枢销474可以任何合适的结构限制在孔478A、478B内。内管468开口包含安装到夹钳454的近端的致动器杆490。当致动器杆490沿箭头482指示的方向从近端轴向运动到远端时,致动器杆490驱动夹紧臂组件沿箭头458指示的方向绕枢转点472旋转至其打开位置。当夹钳454处于打开位置时,形成在夹钳454的顶部表面上的纵向通道486在其内接收内管468的纵向部分。轴向可动的致动器杆490可以任何适合的方式运动,且在一种实施方式中由开关480控制。当致动器杆490沿箭头484指示的方向从远端轴向运动到近端时,致动器杆490驱动夹钳454沿箭头459指示的方向绕枢转点472旋转至其闭合或者夹紧位置。
夹紧垫470附装到夹钳454上并用于挤压超声刀456和夹钳454之间的组织。夹紧垫470可通过粘合剂或者优选通过机械紧固配置安装到夹钳454上。锯齿488可以形成在夹紧垫470的夹紧表面上并垂直超声刀456的轴线延伸,以允许抓取、操纵、凝结和切割组织,而不会在夹钳454和超声刀456之间滑动。
夹紧垫470可由聚合或者其它顺应性材料形成并在夹钳454处于其闭合位置时接合超声刀456。优选地,夹紧垫470由具有低摩擦系数但具有极大刚性的材料、例如(E.I.Du Pont deNemours and Company关于聚合物聚四氟乙烯(PTFE)的商标名)形成以提供组织抓取能力。夹紧垫470可以用其他材料形成,诸如聚酰亚胺材料和/或其他填充的材料,例如石墨或者TEFLON填充的聚酰亚胺材料。聚酰亚胺材料的一种例子是(E.I.DuPont de Nemours and Company的商标名)。例如,聚酰亚胺提供一种塑料、金属和陶瓷的物理特性的独特结合。在一个实施例中,夹紧垫470可以由多个部件和多种材料形成。例如,夹紧垫470可包括一种由TEFLON形成的部件和由聚酰亚胺形成的另一部件。夹紧垫470可包括基本材料和至少两种填充材料,以允许基本材料和所述至少两种填充材料利用不同的硬度、刚度、润滑性、动摩擦系数、传热系数、耐磨性、热变形温度和/或熔化温度来选择,以提高夹紧垫470的耐用性,这在采用高夹紧力时是重要的,因为夹紧垫470在高夹紧力时比低夹紧力时磨损得更快。例如,填充15%石墨、30%PTFE的聚酰亚胺夹紧垫470可在4.5磅夹紧力时与100%PTFE夹紧垫在1.5磅夹紧力时提供相同或者更好的耐用性。填充15%石墨、30%PTFE的聚酰亚胺夹紧垫470的优势在于增加的耐热性,这提高了夹紧垫470的整体耐用性。与PTFE夹紧垫高达大约660°F的有用热阻相比,这种聚酰亚胺复合夹紧垫具有高达800°F到大约1200°F的有用热阻。替代地,其它材料也可用于夹紧垫470的一部分,例如陶瓷、金属、玻璃和石墨。
在替代实施方式中,夹钳454能够收回而不是折回。在一种实施方式中,超声刀456也能够以合适方式收回。
图18-20示出可以与图14-17中讨论的超声器械一起采用的端部执行器的一种实施方式。在所示的实施方式中,适于并构造有图18-20中示出的端部执行器502的超声器械450整体被示作超声器械500。超声器械500的一种实施方式包括位于远端122的端部执行器502。超声器械500沿着轴线“L”在远端124和近端122之间纵向延伸。端部执行器502包括不振动夹钳504和超声刀456。夹钳504比图14-17中所示的端部执行器452的夹钳454提供增加的机械优势。图18是夹臂组件504处于闭合位置的端部执行器502的一种实施方式的俯视透视图;图19是夹臂组件502处于打开位置的端部执行器504的一种实施方式的俯视透视图;图20是夹钳504处于打开位置的端部执行器502的一种实施方式的分解图。
参照图18-20,夹钳504枢转地安装在枢转点506处并能够如箭头458所示从远端到近端旋转至打开位置,该打开位置使超声刀暴露出来用于再成形和凝结组织。夹钳504能够如箭头459所示从远端到近端旋转至闭合位置,用于将刀456和夹钳504之间的组织向刀456一侧挤压,从而利用振动的剪切动作来提高组织切割/凝结效果。夹钳504包括夹紧垫470,该夹紧垫470上构造有垂直于超声刀456的轴线“L”延伸的锯齿488。锯齿488允许组织被抓取、操纵、凝结和切割,而不在夹钳504和超声刀456之间滑动。
超声器械500包括外管462。如前所述,外管462具有大致圆形截面和纵向开口或者孔466以接收处于收回或者折回打开位置的夹钳504。外管462能够接收第一内管518,该第一内管包括“D”形截面并在其内限定孔520以接收细长构件512的远侧部分。细长构件512包括枢转基础构件515和通道514。通道514能够接收致动器杆516。外管462包含能够接收刀456的超声传输波导管457部分的第二内管522。
枢转点506设置在细长构件512的远端处。夹钳504通过穿过第一孔510A、第二孔510B和第三孔510C接收的枢销508可枢转地安装到枢转点506。夹钳504利用第一连杆532A和第二连杆532B连接到致动器杆516。第一和第二连杆532A、532B利用穿过形成于第一连杆532A的远端处的第一孔528B、形成在第二连杆532B的远端处的第二孔530B、和形成在夹钳504中的狭槽536接收的销534连接到夹钳504。狭槽536与纵向轴线“L”成一定角度地形成,以使销534能够在夹钳504旋转过程中在狭槽536内具有一定自由度的运动。第一和第二连杆532A、532B利用穿过形成于第一连杆532A的近端处的第一孔528A、形成在第二连杆532B的近端处的第二孔530A、和形成在致动器杆516的远端处的第三孔540接收的销526连接到致动器杆516。
图21-24示出了夹钳504从图21中的打开位置转换成图24中的闭合位置和图22和23中的中间位置。如图所示,当致动器杆516沿箭头482指示的方向被推进时,在第一和第二连杆532A、532B上施加推进力,夹钳504沿箭头459指示的方向围绕枢转点506枢转至图18所示的夹钳504闭合位置。此时,夹紧垫470顶靠刀456。当致动器杆516沿箭头484指示的方向收回时,在第一和第二连杆532A、532B上施加收回力,且夹钳504沿箭头458指示的方向围绕枢转点506枢转到图19所示的夹钳504打开位置。
图25和26示出了可以与图14-17中讨论的超声器械450一起采用的端部执行器552的一种实施方式。超声器械450适于并构造有图25和26中所示的端部执行器552,总体上被称为超声器械550。超声器械550的一种实施方式包括位于远端122处的端部执行器552。超声器械550沿着轴线“L”在远端124和近端122之间纵向延伸。端部执行器552包括不振动夹钳504和超声刀556。夹钳504比图14-17中所示的端部执行器452的夹钳454提供增加的机械优势。图25是夹臂组件504处于打开位置的端部执行器552的一种实施方式的俯视透视图;且图26是夹钳504处于打开位置的端部执行器552的一种实施方式的分解图。
参照图25和26,端部执行器552包括如前面参照图18-24描述的枢转安装在枢转点506处的夹钳504。端部执行器552包括超声刀556,该超声刀556具有宽阔的基本上平的顶部表面558和光滑的基本上圆的底部表面560且非常适于凝结和组织再成形应用。刀556的宽阔的基本上平的顶部表面相对于宽度非常宽和薄,非常适于从骨去除肌肉组织且被称为超声提升刀。
超声器械550包括外管462。如前所述,外管462具有大致圆形截面并限定纵向开口或者孔466以接收处于收回或者折回打开位置的夹钳504。外管462能够接收内管562,内管562包括圆形截面,且壁554限定接收细长构件512的第一孔566和接收刀556的超声传输波导管部分577的第二孔。细长构件512包括枢转基础构件515和通道514。通道514能够接收致动器杆516。
枢转点506形成在细长构件512的远端。夹钳504利用穿过第一孔510A、第二孔510B和第三孔510C接收的枢销508可枢转地安装到枢转点506。夹钳504利用第一连杆532A和第二连杆532B连接到致动器杆516。第一和第二连杆532A、532B利用穿过形成于第一连杆532A的远端处的第一孔528B、形成在第二连杆532B的远端处的第二孔530B、和形成在夹钳504中的狭槽536接收的销534连接到夹钳504。狭槽536与纵向轴线“L”成一定角度地形成,以使销534能够在夹钳504旋转过程中在狭槽536内具有一些运动自由度。第一和第二连杆532A、532B利用穿过形成于第一连杆532A的近端处的第一孔528A、形成在第二连杆532B的近端处的第二孔530A、和形成在致动器杆516的远端处的第三孔540接收的销526连接到致动器杆516。图21-24示出了夹钳504从图21中的打开位置转换到图24中的闭合位置和图22和23中的中间位置。
这里公开的装置可设计成在一次使用后丢弃,或者可设计成多次使用。然而,在任一种情况下,该装置可在至少一次使用后修复以备再次使用。修复可包括装置的拆卸、接着清洗或更换特定部件和随后的重新组装这些步骤的任意组合。特别地,该装置可以被拆卸,任何数量的特定部件或零件可以有选择地以任意组合被更换或去除。在清洗和/或替换特定部件之后,该装置可在修复设备中或在即将进行手术程序之前由手术队进行重新组装以便以后使用。本领域普通技术人员将会理解对该装置的修复可利用用于拆卸、清洗/替换、和重新组装的各种技术。这些技术的使用以及产生的修复好的装置也全都在本申请的保护范围内。
优选地,本文中公开的各种实施方式将在外科手术前被处理。首先,获取新的或者使用过的器械并在需要的情况下对其进行清洁。该器械然后进行灭菌。在一种灭菌工艺中,器械被放置在闭合且密封的容器中,例如塑料袋或者TYVEK(高密度聚乙烯合成纸袋)。容器和器械然后被放置在可穿透容器的辐射场中,诸如γ射线、x射线或者高能电子。辐射杀死器械上以及容器中的细菌。灭菌后的器械然后可被储存在无菌容器中。密封的容器保持器械处于无菌状态,直到其在医学设施中被打开。
优选使装置被灭菌。这可以通过本领域技术人员已知的多种方式,包括β或者γ射线、环氧乙烷、蒸汽和其它方法来完成。
尽管这里已经描述了多种实施方式,但可以实施这些实施方式的修改和变型。例如,可以采用不同类型的端部执行器。同样,尽管公开了用于特定部件的材料,但可以使用其它材料。前文的描述和权利要求用来覆盖所有这些变型和修改。
被声称通过引用而全部或者部分并入本文中的任何专利、公开出版物或者其它公开材料,仅限于被并入的材料不会与本申请中公开的定义、陈述或者其它公开的材料相矛盾的部分。如此一来,必要时这里明显阐述的公开内容替代任何通过引用而并入本文中的相矛盾的材料。被声称通过引用并入本文中但是与本发明公开的定义、陈述或者其它公开的材料矛盾的任何材料或其部分将只并入不会使得所并入的材料与本发明公开的材料相矛盾的部分。
Claims (6)
1.一种外科器械,包括:
端部执行器,该端部执行器包括超声刀和夹钳,所述夹钳包括组织接合部分和致动器接合部分,其中,所述夹钳能够围绕枢转点沿着弧形路径从闭合位置旋转至打开位置,并且在所述闭合位置和所述打开位置,所述夹钳与由端部执行器限定的纵向轴线基本对准,其中,在所述闭合位置,所述夹钳相对于所述枢转点位于远侧,在所述打开位置,所述夹钳相对于所述枢转点位于近侧,所述外科器械还包括:
连接到所述夹钳的致动器构件,所述致动器构件能够沿所述纵向轴线在第一方向上运动,以导致所述夹钳围绕所述枢转点沿着所述弧形路径旋转至闭合位置,并能够沿着所述纵向轴线在第二方向上运动,以导致所述夹钳围绕所述枢转点沿着所述弧形路径朝着打开位置旋转,所述夹钳的致动器接合部分包括纵向通道,以在夹钳处于打开位置时在其内接收致动器构件的纵向部分。
2.如权利要求1所述的外科器械,包括能够沿所述纵向轴线产生预定频率振动的换能器。
3.如权利要求2所述的外科器械,其中,所述端部执行器包括至少一个治疗区域和远侧尖端,所述远侧尖端连接到所述换能器并与所述纵向轴线基本对准,其中所述远侧尖端能够通过所述换能器产生的振动相对于所述轴线运动。
4.如权利要求3所述的外科器械,其中,所述治疗区域包括具有凿子形远侧尖端的所述超声刀。
5.如权利要求4所述的外科器械,其中,所述超声刀包括宽阔的基本平的顶部表面和光滑的基本圆的底部表面。
6.如权利要求1所述的外科器械,其中,所述致动器构件包括纵向延伸穿过其的开口以在所述夹钳位于打开位置时接收所述夹钳,并且还包括连接到位于所述开口内的夹钳的致动器杆。
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AU2008231089A1 (en) | 2008-10-02 |
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CN101674782A (zh) | 2010-03-17 |
CA2682228A1 (en) | 2008-10-02 |
AU2008231089B2 (en) | 2013-09-12 |
US9504483B2 (en) | 2016-11-29 |
JP5450107B2 (ja) | 2014-03-26 |
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JP2010522033A (ja) | 2010-07-01 |
EP2131762A4 (en) | 2013-11-27 |
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