CN101522128B - 具有柔性铰接轴的内窥镜血管密封及分割装置 - Google Patents
具有柔性铰接轴的内窥镜血管密封及分割装置 Download PDFInfo
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- A61B18/14—Probes or electrodes therefor
- A61B18/1442—Probes having pivoting end effectors, e.g. forceps
- A61B2018/1452—Probes having pivoting end effectors, e.g. forceps including means for cutting
- A61B2018/1455—Probes having pivoting end effectors, e.g. forceps including means for cutting having a moving blade for cutting tissue grasped by the jaws
Abstract
一种用于处理组织的电手术器械,其包括壳体,所述壳体具有从其中延伸出的轴,且穿过所述轴限定了轴线A-A。所述轴至少部分是柔性的并且包括连接在其远端的第一和第二钳口部件。每个钳口部件包括适于连接到电手术能量源的导电组织接触表面以使导电组织接触表面能够通过夹持在钳口部件中的组织来传导电手术能量。驱动组件被设置在壳体中并具有第一致动器,所述第一致动器可操作地连接到驱动杆以使驱动杆往复运动以将钳口部件从彼此呈隔开关系的第一位置移动到彼此更靠近的第二位置以咬合组织。第二致动器设置在壳体中并且可致动以铰接所述轴。
Description
相关申请的交叉引用
本申请要求由埃里克·泰勒等人于2006年10月6号提交的名称为“具有柔性铰接轴的内窥镜血管密封及分割装置”、序列号为60/850,214的美国临时专利申请的优先权利益,其全部内容通过引用合并于此。
技术领域
本公开涉及一种电手术镊,本公开尤其涉及一种用于密封和/或切开组织的内窥镜电手术镊,其利用了细长、大体柔性且铰接式的轴。
背景技术
电手术镊利用机械钳位作用和电能通过加热组织和血管以凝结、烧灼和/或密封组织来实现止血。作为在开放式手术操作中使用的开口镊的备选方案,许多现代的外科医生利用内窥镜和内窥镜器械通过小的刺孔状切口远距离地进入器官。其直接结果是,病人往往受益于较小的疤痕和缩短的恢复时间。
通常,内窥镜手术涉及切穿体壁,例如在卵巢、子宫、胆囊、肠、肾、阑尾等上观察和/或操作。存在许多常用的内窥镜检查性手术操作,包括关节镜检查、腹腔镜检查(盆腔检查)、胃肠镜检查以及喉支气管镜检查等,仅仅列举了几个。典型地,利用套针产生切口,通过切口来实施内窥镜手术。
将套针管或套管装置延伸进腹壁中并留在腹壁中适当的位置以提供用于内窥镜手术工具的入口。将照相机或内窥镜通过相对较大直径的通常位于腹部切口(naval incision)处的套针管插入,照相机或内窥镜允许目视检查和放大体腔。然后在诸如手术镊、刀具、涂药器等设计为通过另外的套管安装的专用器械的辅助下,外科医生能够在手术部位处实施诊断和治疗操作。因此,经历内窥镜手术的病人获得了尺寸在5至10毫米之间的更具美观吸引力的切口,而不是切穿大量肌肉的大切口(典型地为12英寸或更大)。因此,和传统手术相比,痊愈的更快并且病人需要较少的麻醉。此外,因为极大地放大了手术区,因此外科医生能够更好地剖割血管及控制失血。
在减少手术外伤的持续努力下,近来注意力发展到了以下可能性:通过利用自然腔道(例如,嘴或肛门)进入目标组织来实施操作以诊断和手术处理医疗状况而不在腹壁中留下任何切口。这种操作有时被称作腔内操作、经腔操作或经自然腔道内镜手术(“NOTES”)。尽管许多这样的腔内操作仍然在被开发,但是它们通常利用柔性的内窥镜器械或柔性导管为目标组织提供入口。腔内操作已经用于处理内腔(lumen)中的状况,包括例如治疗食道中的胃食管逆流疾病和从结肠中去除息肉等。在一些病例中,医生已经超出胃肠管道的腔区域以实施腹内的操作。例如,利用柔性的内窥镜器械,能穿透胃壁并且将内窥镜推进到腹腔以实施各种操作。
据报道,利用这种腔内技术,已经在动物模型中实施了诊断探察、肝活组织检查、胆囊切除术、脾切除术以及输卵管结扎。在完成腹内介入之后,将内窥镜仪器退回到胃中,且使穿孔闭合。其它的诸如肛门和阴道的自然腔道也可以允许进入到腹腔。
如上所述,许多内窥镜手术操作和腔内手术操作典型地需要切开或结扎血管或维管组织。然而,这最终向器械制造者提出了设计挑战,制造者必须尝试找到方法制造出可以通过较小的套管安装的内窥镜器械。由于手术腔的固有空间条件,外科医生经常在缝合组织或实施例如夹紧和/或打结横断的血管等其它传统控制出血的方法中遇到困难。通过利用内窥镜电手术镊,外科医生简单地通过控制经过钳口部件施加到组织上的电手术能量的强度、频率和持续时间,就能够烧灼、凝结/干燥出血和/或简单地减少或减慢出血。利用标准的电手术器械和技术通常能够闭合大多数小血管,即直径在2毫米以下范围内的小血管。然而,如果结扎较大血管,外科医生必须将内窥镜操作转变为开放式手术操作,因此放弃了内窥镜手术的优势。可选择地,外科医生能够利用专用血管密封器械来密封较大血管或组织。
认为凝结血管的过程根本不同于电手术血管密封。为此目的,将“凝结”定义为使组织变干的过程,其中使组织细胞破裂并且变干。将“血管密封”或“组织密封”定义为使组织中的胶原熔化以使其转化为熔体的过程。使小血管凝结足以使它们持久的闭合,而较大血管需要被密封以确保持久的闭合。而且,使大组织或血管凝结会导致众人皆知的破裂强度低的弱近血栓(weakproximal thrombus),而组织密封具有相对高的破裂强度并且可以沿着组织密封平面被有效地切断。
具体来说,为了有效地密封较大血管(或组织),可以精确地控制两个主要的机械参数-施加到血管(组织)上的压力和电极之间的间距-这两个参数受被密封的血管的厚度影响。具体来说,精确施压对于对抗血管壁、将组织阻抗减小至允许足量电手术能量通过组织的足够低的值、克服组织加热期间的膨胀力以及促成指示良好密封的目标组织厚度都是很重要的。已经判定出:典型的熔凝的血管壁在0.001至0.006英寸之间为最适宜。低于这个范围,密封可能扯碎或破缝,而高于这个范围,可能不会适当且有效地密封内腔。
对于较小的血管来说,施加到组织上的压力对于有效密封往往变得不是很相关,而导电表面之间的间距对于有效密封变得更加重要。换句话讲,随着血管变小,在激活期间两个导电表面接触的机会增加。
已经发现,用来确保始终如一且有效密封的压力范围在约3kg/cm2至约16kg/cm2之间,理想地,在7kg/cm2至13kg/cm2的工作范围内。已经证明,制造一种能够提供在所述工作范围内的闭合压力的器械对于密封动脉、组织和其它血管束是有效的。
过去已经开发出了用于提供适当的闭合力以实现血管密封的各种力致动组件。例如,序列号为10/460,926和11/513,979的共有的美国专利申请公开了两种不同的预想的致动组件,其是由Vallylab-Tyco医疗健康集团的分公司、位于科罗拉多州(Colorado)的博尔德(Boulder)-研发的,其与在商标 下共同销售的Vallelab的血管密封及分割器械一起使用。这些申请的内容都通过引用合并于此。
在使用期间,当产生上述所需的力以实现可靠的血管密封时,对外科医生来讲一个显著的挑战是,不能操纵血管密封器的末端执行器组件以在多个平面即离轴的平面上抓紧组织。因此,需要开发一种包括末端执行器组件的内窥镜或腔内血管密封器械,该末端执行器组件能够沿着多个轴被控制以使外科医生能够抓紧并密封在手术腔内位于不同平面的血管。
腔内操作经常需要利用柔性导管或内窥镜进入自然内腔的弯曲构造的深处的组织。传统的血管密封装置由于刚性轴不易通过自然内腔的弯曲构造而可能不适用于一些腔内操作。因此需要开发一种具有能够插入柔性内窥镜或导管中的柔性轴的内窥镜或腔内血管密封器械。
发明内容
本公开涉及一种用于处理组织的电手术器械,其包括壳体,所述壳体具有从其中延伸出的柔性轴,穿过柔性轴限定了轴线A-A。所述轴包括连接在其远端的第一及第二钳口部件,每一钳口部件包括适于连接至电手术能量源的导电组织接触表面。一旦电激活,导电组织接触表面通过夹持在钳口部件之间的组织来传导电手术能量。驱动组件嵌入所述壳体中,其包括第一致动器和第二致动器,所述第一致动器可操作地连接至驱动杆以使驱动杆往复运动,所述第二致动器可操作地连接至驱动杆以使驱动杆转动。所述电手术器械包括刀具,所述刀具可操作地连接至驱动杆的远端。所述第一致动器的致动使钳口部件从彼此呈隔开关系的第一位置移动至彼此更靠近的第二位置以咬合组织。所述第二致动器的致动使驱动杆绕轴线A-A转动以使刀具平移以切开位于钳口部件之间的组织。
在一实施例中,手术镊包括连接至驱动杆的远端的凸轮组件。所述凸轮组件包括凸轮毂,凸轮毂具有限定在其中的配置为与设置在刀具上的相应的棘爪匹配地接合的开槽外周。所述驱动杆的转动运动相应使凸轮毂转动,凸轮毂依次使棘爪及刀具相对于钳口部件平移。联结器装置例如带键杆(keyedrod)被配置为在一端与驱动杆接触,而在相反端匹配地接合限定在凸轮毂中的键状孔口。
在另一实施例中,所述柔性轴包括嵌套地串联排列以形成柔性轴的至少一部分的多个接头。每一接头包括穿过其限定的至少一个内腔以允许驱动杆在其中往复运动。在一实施例中,每一接头包括形成在其中的中央内腔以及形成在中央内腔两侧的一对对置的内腔。所述电手术器械可以包括可滑动地贯穿相应的对置的内腔的一对铰接电缆,所述铰接电缆相对于彼此可活动以相对于轴线A-A铰接所述轴。
在又一实施例中,可以包括第三致动器,其可操作地连接至所述壳体,用于使一对铰接电缆相对于彼此运动以相对于轴线A-A铰接柔性轴。
本公开还涉及一种用于处理组织的电手术器械,其包括壳体,所述壳体具有从其中延伸出的柔性轴,穿过柔性轴限定了轴线A-A。末端执行器组件连接在所述轴的远端,所述末端执行器组件包括U形件(clevis),所述U形件绕枢轴销支撑第一及第二钳口部件以使钳口部件相对于彼此可以活动。每一钳口部件包括适于连接至电手术能量源的导电组织接触表面,以使导电组织接触表面能够通过其间夹持的组织来传导电手术能量。所述每一钳口部 件包括限定在其中的倾斜凸轮面,并且所述U形件包括限定在其中的槽。刀具可操作地连接至驱动杆的远端,而驱动组件设置在壳体中。所述驱动杆组件包括第一致动器和第二致动器,所述第一致动器可操作地连接至驱动杆以使驱动杆往复运动,所述第二致动器可操作地连接至驱动杆以使驱动杆转动。所述驱动杆的远端配置为容纳驱动销,所述驱动销与限定在钳口部件中的凸轮面以及限定在U形件中的槽接合,以使第一致动器的致动使驱动销往复运动以将钳口部件从彼此呈隔开关系的第一位置运动至彼此更靠近的第二位置以咬合组织,而所述第二致动器的致动使驱动杆绕轴线A-A转动以使刀具平移以切开位于钳口部件之间的组织。
在一实施例中,凸轮组件连接至驱动杆的远端,所述凸轮组件包括凸轮毂,所述凸轮毂具有限定在其中的开槽外周。所述开槽外周被配置为匹配地接合设置在刀具上的相应的棘爪,其中驱动杆的转动运动相应使凸轮毂转动,凸轮毂依次使棘爪及刀具相对于钳口部件平移。所述驱动杆被滑动地容纳在凸轮毂内以使驱动杆的轴向移动不会使刀具进行往复运动。
本公开还涉及一种用于处理组织的电手术器械,其包括壳体,所述壳体具有从其中延伸出的轴,穿过轴限定了轴线A-A。所述轴至少部分为柔性的并且包括连接在其远端的第一及第二钳口部件。每一钳口部件包括适于连接至电手术能量源的导电组织接触表面,以使导电组织接触表面能够通过其间夹持的组织来传导电手术能量。驱动组件设置在壳体中并且具有第一致动器,所述第一致动器可操作地连接至柔性驱动杆以使柔性驱动杆往复运动以将钳口部件从相对于彼此呈隔开关系的第一位置运动至彼此更靠近的第二位置从而咬合组织。第二致动器设置在壳体中并且可致动以铰接所述轴。
在一实施例中,所述轴的柔性部分包括嵌套地串联排列的多个接头。每一接头可以被配置为包括穿过其限定的一个或多个内腔以允许驱动杆和铰接电缆在其中往复运动。
在一实施例中,第二致动器包括铰接组件,所述铰接组件具有设置在壳体上的一个或多个用户致动元件(例如轮),所述用户致动元件可操作地连接至滑轮系统以使铰接电缆穿过所述轴往复运动。铰接组件还可以包括一个或多个导引件,其用于将一对铰接电缆导引到滑轮系统中及用于预拉伸铰接电缆。
在另一实施例中,所述驱动组件包括可操作地连接至驱动杆的四杆机械联动杆,其中所述四杆机械联动杆的致动使驱动杆往复运动,所述驱动杆依次使钳口部件从相对于彼此呈隔开关系的第一位置运动至彼此更靠近的第二位置从而咬合组织。
在又一实施例中,调节致动器连接至驱动杆,其允许制造者调节当钳口部件设置在第一位置时钳口部件的相对距离。
附图说明
在此结合附图描述主题器械的各个实施例,其中:
图1为根据本公开的内窥镜手术镊的立体图,示出了壳体、柔性轴和末端执行器组件;
图2为图1的柔性轴(不带外壳)和末端执行器组件的放大正视立体图;
图3为部件分离的柔性轴和末端执行器组件的放大后视立体图;
图4为末端执行器组件的凸轮机构的高度放大的立体图;
图5为图2所示的柔性轴和处于打开结构的末端执行器组件的侧面截面图;
图6为图2所示的柔性轴和处于闭合结构的末端执行器组件的侧面截面图;
图7为图2的柔性轴和末端执行器组件的侧面截面图,示出了切割机构的远侧平移运动,所述切割机构被配置为切开位于末端执行器组件的钳口部件中的组织;
图8为图2的末端执行器组件处于未铰接状态的纵向截面图;
图9为图2的末端执行器组件处于铰接状态的纵向截面图;
图10为壳体的截面图,示出了电手术电缆(electrosurgical cable)和电引线的内部电线路;
图11为图10中指示的细节区域的高度放大的视图;
图12为根据本公开的内窥镜手术镊的另一个实施例的立体图,示出了壳体、部分柔性轴和末端执行器组件;
图13为图12的部分柔性轴的放大立体图;
图14A为图13的部分柔性轴的放大分解立体图;
图14B为根据本公开的精调机构的高度放大的立体图;
图14C为图12的手术镊的壳体的分解立体图;
图15A为壳体的后视立体图,示出了设置在其中的各个内部元件;
图15B为壳体的正视立体图,示出了设置在其中的各个内部元件;
图16A为图13的部分柔性轴的侧面截面图,所示的末端执行器组件处于打开状态;
图16B为图13的部分柔性轴的正视立体图,所示的末端执行器组件处于打开状态;
图16C为图13的部分柔性轴的仰视立体图,所示的末端执行器组件处于局部打开状态;
图17A为图13的部分柔性轴的侧面截面图,所示的末端执行器组件处于闭合状态;
图17B为图13的部分柔性轴的正视内部立体图,所示的末端执行器组件处于闭合状态;
图18A为依照本公开的铰接组件的放大内部立体图;
图18B为图13的部分柔性轴处于对准、非铰接方位中的俯视截面图;
图18C为图13的部分柔性轴处于铰接方位的俯视截面图;
图19A为壳体的侧面截面图,示出了处于基本闭合方位的手术镊;
图19B为壳体的侧面截面图,示出了处于基本打开方位的手术镊;以及
图20A和图20B为齿轮部件和铰接组件的铰接轮的放大侧面立体图。
具体实施方式
本公开涉及一种电手术镊,本公开尤其涉及一种用于密封和/或切开组织的内窥镜电手术镊,其利用了细长、大体柔性且铰接式的轴。例如,在一个实施例中,这种装置包括手柄、手柄组件或其它连接到柔性细长主体部或轴的近端的合适的致动机构(例如机械手等)。柔性轴的远侧部包括由一个或多个接头组成的铰接部以允许响应于铰接电缆的致动而铰接末端执行器离开纵轴。末端执行器被可操作地支撑在柔性轴的远端。末端执行器包括能够在闭合位置和打开位置之间被致动的一对钳口。钳口适用于将电能供给到钳口之间抓紧的组织上。末端执行器还包括能被致动以切开钳口中抓紧的组织的刀具组件。
通过手柄中的各种机构的致动能够远离手柄实施打开和闭合钳口、操作刀具组件和铰接末端执行器的功能。通过柔性轴内的柔性电缆或杆可以将机械运动从手柄经过柔性轴传递到末端执行器。例如,在一个实施例中利用两个电缆提供铰接;一个推拉型电缆打开和闭合钳口;以及另一个推拉型电缆致动刀具组件。该装置适用于放置在柔性内窥镜的内腔中,然后插入病人的自然腔道中,并且通过自然内腔的构造自腔内转到自然内腔内或外部的处理位置上。
现在转到图1至图3,示出了用在各种手术操作中的内窥镜血管密封手术镊10的一个实施例,其通常包括壳体20、手柄组件30、转动组件80、铰接组件90、扳机组件70和末端执行器组件100,这些组件相互协作以转动、铰接、抓紧、密封和分割管状血管和维管组织。尽管大部分附图描述了用在内窥镜手术操作中的两极密封手术镊10,但是本公开可以用于单极手术操作,其采用了远距离的病人垫片(patient pad)来完成电流环路。
手术镊10包括大体柔性轴12,轴12具有尺寸被确定为与末端执行器组件100机械接合的远端16和与壳体20机械接合的近端14。在一个实施例中,轴12具有至少两个部分,近侧部和远侧部。轴的近侧部可以由柔性管材组成(例如,塑料),并且可以结合编织钢管以提供轴向强度(例如,有压缩性的)和转动强度。轴12的远侧部也可以是柔性的,但是可以结合一个或多个活动接头。可以采用外壳12’保护柔性轴12的多个内部活动接头12a。
在一个实施例中,轴的近侧部是柔性的和非铰接式的,而轴12的远端部能够响应于铰接电缆或电线的运动而铰接。下面结合图8和图9更详细地描述轴12如何弯曲的细节。轴12的近端14容纳在壳体20中并且与转动组件80、铰接组件90以及驱动组件150连接。在附图和以下描述中,术语“近侧”将按照惯例指手术镊10的更靠近使用者的一端,而术语“远侧”将指远离使用者的一端。
如图1中最佳地示出的,手术镊10还包括电手术电缆310,其将手术镊10连接到例如发电机(未图示)的电手术能量源上。可以考虑的是,诸如由Vallylab-位于科罗拉多州的博尔德的Tyco医疗健康集团的分公司-销售的发电机可以用作电手术能量源,例如Vallylab的LIGASURETM血管密封发电机和Vallylab的Force TriadTM发电机。
发电机可以包括各种安全和性能特征,包括绝缘输出、独立的附件激活和/或所谓的“Instant ResponseTM”软件,所述软件是由Vallylab-Tyco医疗健康集团的分公司拥有的专有技术。Instant ResponseTM是一种先进的反馈系统,其每秒钟感知200次组织的变化并调整电压和电流以保持适当的功率。认为Instant ResponseTM技术对血管密封提供了一个以上的下列优点:对所有组织类型的临床效果一致;减少了热量传播和周边组织损坏的风险;对“调大发电机”的需要更小;以及设计用于微创环境。
如以下结合图10至图11更详细说明的,电缆310内部被分为电缆引线310a、310b和310c,每个电缆引线通过其各自的供电路径将电手术能量通过手术镊10传输到末端执行器组件100。
手柄组件30包括固定手柄50和活动手柄40。如以下结合手术镊10的操作更详细描述的,固定手柄50与壳体20整体地关联,而手柄40相对于固定手柄50可活动。转动组件80可以与壳体20整体地关联,并且可以经由绕穿过轴12所限定的纵轴“A-A”在任一方向上将轮82转动大约180度而转动。在序列号为10/460,926的共有的美国专利申请中公开了一个设想的转动组件80。在序列号为11/519,586的共有的美国专利申请中公开了另一个设想的转动组件。两个申请的全部内容通过引用合并于此。
铰接组件90也可以与壳体20整体地关联,并且可经由轮92操作以相对于轴线“A-A”在箭头“B-B”的方向上移动末端执行器组件100。轮92可以设置为可选的配置,诸如设置在壳体的一侧。而且,可以用其它机构代替轮92以致动诸如杠杆、轨迹球、操纵杆等的铰接组件90。下面将结合图8和图9更详细地描述关于铰接组件90的细节。
如上所述,末端执行器组件100连接在轴12的远端16,并且包括一对对置的钳口部件110和120。手柄组件30的活动手柄40最终连接到驱动组件150,它们一起机械协作以使钳口部件110和120从打开位置到夹住或闭合位置运动,在打开位置,钳口部件110和120相对于彼此呈隔开关系设置,在夹住或闭合位置,钳口部件110和120协作以抓紧二者间的组织。
现在转到本发明的镊壳体20、轴12和末端执行器组件100的更详细的特征,活动手柄40可选择性地绕枢轴销29从相对于固定手柄50的第一位置运动到更接近固定手柄50的第二位置,如下面所述这使钳口部件110和120相对于彼此运动。活动手柄包括U形件45,U形件45形成了一对上凸缘,每 个上凸缘在其上端具有一个用于容纳通过其中的枢轴销29的孔。依次,销29安装到壳体20的两侧上。
U形件45还包括力致动凸缘或驱动凸缘(未图示),力致动凸缘或驱动凸缘沿着纵轴“A-A”排列,并且其邻接驱动组件150以使手柄40的枢轴运动迫使致动凸缘抵靠驱动组件150,驱动组件150依次闭合钳口部件110和120。活动手柄40的下端包括凸缘91,凸缘91安装在活动手柄40上并且包括t形远端95,t形远端95安放在设置在固定手柄50中的预限定槽51内以相对于固定手柄50锁定活动手柄40。
末端执行器组件100包括对置的钳口部件110和120,钳口部件110和120协作以有效地抓紧组织用于密封目的。末端执行器组件100可以设计为单侧组件或双侧组件,单侧组件即钳口部件120相对于轴12固定而钳口部件110绕枢轴销103枢转以抓紧组织,双侧组件即两个钳口部件110和120都相对于轴线“A-A”运动。驱动杆142或驱动套管可操作地连接到驱动组件150,并且经由手柄40相对于手柄50的运动可选择地往复运动以使钳口部件110和120相对于彼此致动,即枢转。在装置的一个实施例中,驱动杆142是柔性的,并且例如可以为电缆。
根据本公开的一个特殊实施例,如图1至图3中最佳示出的,可以分别在上钳口部件110和/或下钳口部件120中限定刀槽115a和115b。刀槽115a和115b尺寸被确定为分别贯穿钳口部件110和120的中心,以使当钳口部件110和120处于闭合位置时,刀片185能够可选择地往复运动以切开抓紧在钳口部件110和120之间的组织。刀片185可以被配置(或者刀片185与末端执行器组件100或驱动组件150结合)为使得刀片185仅可以在钳口部件110和120闭合时被推进通过组织,从而防止刀片185偶然的或过早的致动通过组织。
如图2和图3最佳示出的,钳口部件110包括绝缘钳口壳体114和导电表面112。绝缘体114尺寸被确定为通过印模、通过二次注塑、通过二次注塑印模导电密封板和/或二次注塑金属注模密封板与导电密封表面112牢固地接合。所有这些制造技术产生具有被绝缘钳口壳体114基本环绕的导电表面112的钳口部件110。钳口部件110还可以包括设计为引导电缆引线311与密封表面112电连续的一个或多个导线孔或通道(未图示)。
当组装时,导电表面112和绝缘钳口壳体114形成穿过其限定的用于刀片185的往复运动的纵向方向槽115a,可以设想,刀槽115a与在钳口部件120中限定的相应的刀槽115b协作以利于刀片185沿着优选切割平面纵向延伸,以有效且精确地沿着形成的组织密封分离组织。
钳口部件120包括类似于钳口部件110的元件,诸如绝缘钳口壳体124和尺寸被确定为与绝缘钳口壳体124牢固地接合的导电密封表面122。同样,当组装时,导电表面122和绝缘钳口壳体124包括穿过其限定的用于刀片185的往复运动的纵向方向槽115a。如上所述,当钳口部件110和120关于组织闭合时,刀槽115a和115b允许刀具185以远端方式纵向延伸以沿着组织密封切开组织。取决于特殊的目的,可以完全在两个钳口部件的一个中,例如在钳口部件120中设置单个刀槽,例如115b。钳口部件120可以以与上述钳口部件110相似的方式组装。
钳口部件120包括一系列止挡部件750,这些止挡部件750设置在导电密封表面122的内侧端面上以利于抓紧并操纵组织并且在密封和切开组织期间限定钳口部件110和120之间的间隙“G”(见图7)。在导电密封表面112和122之间能够有效且可靠地密封组织的优选间隙“G”在大约0.001英寸和大约0.006英寸之间。取决于特殊目的或为了达到期望的结果,可以在一个或两个钳口部件110和120上采用止挡部件750。止挡部件750可以热喷射在导电密封板122上面或以本领域中任何已知的方式配置或附着在导电密封板122上。而且,取决于特殊的钳口构造或期望的手术结果,止挡部件750可以沿着导电钳口表面112和122以任何结构设置。
在一个实施例中,钳口部件110和120接合在轴12(或环绕轴12的套筒(未图示))的一端,并且可操作(经由转动组件80)为绕末端执行器组件100的枢轴103转动。引线311将第一电势输送给钳口部件110并且通过驱动杆42(或者可选择地,上述套筒)将第二电势传送给钳口部件120。当激活时,两个电势传递电能通过导电密封板112和122之间夹持的组织。下面将结合图10和图11讨论关于引线311穿过手术镊10的一个设想的电气结构的细节。
驱动杆142的近侧运动使钳口部件110和120枢转至闭合位置。更特别地,一旦手柄40被致动,则手柄40绕枢轴销29朝固定手柄50以大致弓形方式运动,这迫使U形件45在大体近侧方向上拉动往复运动的驱动杆42以 闭合钳口部件110和120。而且,手柄40的近侧转动使得锁止凸缘71释放即“解锁”用于刀具185的选择性致动的扳机组件70。
在序列号为10/460,926的共有的美国专利申请中描述了一个设想的手术镊10的内部工作元件即驱动组件150、扳机组件70和转动组件80的操作特征和相对运动,其全部内容合并于此。
如上所述,理想的是,钳口部件110和120可以被打开、闭合、转动及铰接以操纵并抓紧组织直到密封。这使得在启动和密封之前用户能够定位或重定位手术镊10。如图4所示,末端执行器组件100可以通过转动组件80的转动旋钮82的转动绕纵轴“A-A”转动。如下面结合图8和图9更详细解释的,末端执行器组件100也能够在箭头“B-B”方向上的任一方向上被铰接。一旦组织被抓紧(在大约3kg/cm2至大约16kg/cm2的必要压力范围内),然后用户选择性地施加电手术能量以有效密封组织。一旦密封,然后用户通过选择性地致动扳机组件70来推进刀具185以沿着组织密封切开组织。
上述序列号为10/460,926的共有的美国专利申请描述了一个设想的扳机组件70的操作特征及相对运动。例如,在一个实施例中,扳机组件70的致动导致贯穿轴12且可操作地连接至刀具185的电缆向远侧活动,从而沿着组织密封切开组织。在另一个实施例中,扳机组件包括齿轮装置,齿轮装置将扳机组件的致动转换为穿过轴12的电缆的转动运动。
序列号为10/460,926的美国专利申请还公开了一种设想的驱动组件150,其涉及套筒的选择性的往复运动以打开和闭合钳口部件110及120。序列号为11/519,586的美国申请描述了另一种设想的实施例,其中驱动组件拉动驱动杆以打开及闭合钳口部件110及120。
尤其结合图2及图3,手术镊10包括多个接头12a,所述接头12a嵌套地串联排列以形成柔性轴12。轴12的远端16与末端执行器组件100机械接合,而轴12的近端14与壳体20机械接合。柔性轴12的多个接头12a中的每一个包括一同形成的远侧转向节12b及近侧U形件12c。每个转向节12b与邻接接头12a的U形件12c可操作地接合。每一接头12a限定了形成在其中的中央内腔12d及形成在中央内腔12d的两侧的一对对置内腔12e。一对铰接电缆94a及94b可滑动地贯穿接头12的相应内腔12e。下面将结合图8及图9进一步详细说明电缆94a及94b的操作。
如图3所示,末端执行器组件100包括配置为可枢转地支撑钳口部件110和120的钳口支撑部件222。钳口支撑部件222在其近端限定了内腔224并在其远端限定了一对分离臂226a及226b。内腔224被配置及尺寸被确定为容纳从柔性轴12的最远侧接头12a延伸出的柄12f。内腔224在其表面限定了一对对置的通道224a、224b,通道224a、224b被配置为滑动地容纳刀片185以使刀片185在其中往复运动。
通过钳口枢轴销234将钳口110及120可枢转地安装在支撑部件222上,钳口枢轴销234贯穿形成在支撑部件222的臂226a及226b中的孔口228以及分别形成在钳口部件110及120中的枢轴槽132a及132b。为使钳口110及120在打开位置及闭合位置之间活动,具有凸轮销138的轴向或纵向活动中心杆136在中心杆136的远端136a处被安装在钳口支撑222中。凸轮销138安放于分别形成在钳口部件110及120中的倾斜凸轮槽132a及132b中并且与倾斜凸轮槽132a及132b接合,以使中心杆136的轴向或纵向运动经由驱动杆142导致钳口110及120在打开及闭合位置之间做凸轮运动。
末端执行器组件100还包括带键杆140,带键杆140具有可转动的连接至中心杆136的近端136b的远端140a。带键杆140包括固定连接至驱动杆142的远端的近端140b以及设置在远端140a及近端140b之间的本体部140c,本体部140c具有非圆形的横截面。
末端执行器组件100进一步包括凸轮组件141,凸轮组件141包括凸轮毂144,凸轮毂144具有穿过其限定的内腔144a,内腔144a被配置为并且适于将带键杆140的本体部140c可滑动地容纳在其中。凸轮毂144包括限定在其中的配合机械接口,该配合机械接口与带键杆140的本体部140c的外周结构协作以允许两半部件的可靠接合以用于转动目的,正如以下更详细地说明的。凸轮毂144还包括限定在其外表面的配置为机械接合刀具185的棘爪187的螺线形或螺旋形槽144b,其目的还将在下面更详细的说明。凸轮毂144被配置为可转动地设置在支撑部件222的内腔124中。在可选的实施例中,凸轮毂144可以由其它机构代替以将转动运动转变为线性运动(例如,丝杠、一个或多个齿轮等等)。
在操作中,驱动杆142被配置为提供两个不同且独立的功能:其轴向位移使钳口部件110及120在打开位置与闭合位置之间致动,而其转动运动推进刀具185穿过组织。具体来说,驱动杆142的轴向位移将轴向位移传递至 带键杆140,带键杆140依次将轴向位移传递至中心杆136。然而,由于凸轮毂144被轴向可滑动地支撑在带键杆140上,所以轴向位移没有传递到其上。如图5及图6最佳示出的,驱动杆142在箭头“F”方向上的近侧平移迫使凸轮销138接近进入凸轮槽132a及132b内以必需的闭合压力及在必需的间隙“G”范围内关于组织来闭合钳口部件110及120。在可选的实施例中(未示出),由驱动杆142致动的此功能可以是颠倒的,即由轴向位移推进刀具185,而转动运动打开及闭合钳口部件110及120。然后对导电密封板112及122提供电压以将电能传递通过钳口部件110及120之间夹持的组织。
在提供电能之前,可以采用手术镊10中机械式的或发电机(未示出)中电气式的一个或多个安全特征以保证组织被有效地抓紧在钳口部件110及120之间。
一旦形成适合的组织密封,可以沿着组织密封切断组织。而且,可以采用一个或多个安全特征以保证在切割组织之前已经形成适合的密封。例如,发电机可以包括安全闭锁,安全闭锁电动地防止或电动机械地防止刀具185的驱动,除非适合及有效的密封已经形成。如上所述,重要的是还应注意到,血管或组织密封不仅仅是简单地使组织凝结,而是需要精确地控制压力、电能及间隙“G”以有效地密封组织。
本公开包括刀具185,当其经由扳机组件70被激活时,其渐进地且可选择地沿着理想的组织平面以精确的方式分割组织以有效且可靠地将组织分割成两个密封的等分。刀具185允许用户在密封之后立即快速分离组织,而不需要穿过导管或套管口替换切割器械。可以理解为,组织的精确密封及分割是由同一手术镊10完成的。
可以设想,刀片185也可以连接至相同的或可选的电手术能量源以利于组织沿着组织密封被分离。而且,可以设想,刀片尖端185a的角度可以被定尺寸为取决于特殊的目的而提供更多或更少的主动切削角。例如,刀片185可以以减少与切割关联的“组织束(tissue wisp)”的角度定位。而且,刀片185可以取决于特殊的目的或为达到特殊结果而被设计为具有不同的刀片几何结构,诸如锯齿状、有缺口的、有穿孔的、中空的、凹面的、凸面的等。可以设想,通常刀片185以渐进、单向的方式(即向远侧)进行切割。如上所述,驱动杆执行两种功能:打开及闭合钳口部件110及120和推进刀具185以切断组织(见图7)。为了切断组织,驱动杆142的转动将转动传递给带键 杆140,带键杆140依次将转动传递至凸轮毂144。然而,由于带键杆140可转动地连接至中心杆136,因此没有转动传递到中心杆136上。
末端执行器组件100可操作地与刀具185连接,刀具185被可滑动地支撑在支撑部件222的相应的通道224a及224b内。具体来说,刀具185包括在其远端的锋利或锯齿状的边缘185a及从刀具185近侧延伸出的一对导向凸缘186a及186b。凸缘186a的近端包括棘爪或者突出部187,棘爪或者突出部187被配置为接合并安放在凸轮毂144中限定的螺线形或螺旋形槽144b中。
在操作中,随着凸轮毂144在箭头“C”方向上转动,近端187安放在凸轮毂144的槽144b内并且相对于凸轮毂144的槽144b在轴向“A1”上运动。凸轮毂144在一个方向上的转动迫使刀片185向远侧穿过分别在钳口部件110及120中的刀槽115a及115b,以切断位于其间的组织。在相反方向的转动迫使近端187向近侧缩回刀片185至最近侧位置。弹簧可操作地与凸轮毂144关联以使刀具185偏置在最近侧方位。
如上所述,末端执行器组件100还可以选择性的为铰接式的。具体来说,如图8所示,末端执行器组件100处于轴向对准状态,为了经由铰接组件90铰接末端执行器组件100,轮92被配置为在第一方向上的转动使末端执行器组件100在相应的第一方向上运动,而在相反方向上的转动使末端执行器组件100在相反方向上运动。可以采用各种滑轮组件及齿轮组件实现此目的。
例如,在一个实施例中,手柄组件可以包括可从壳体操作的至少一个铰接电缆。每一铰接电缆包括远端和近端,远端可操作地与末端执行器连接,近端可操作地连接至被支撑在壳体上的至少一个控制元件,例如滑块、转盘、杠杆等。在操作中,控制元件的运动导致至少一个铰接电缆的运动,其中至少一个铰接电缆在第一方向上的运动引起末端执行器的铰接,而至少一个铰接电缆在第二方向上的运动导致末端执行器在第二方向上的铰接。
可以设置一对铰接电缆,每一铰接电缆具有可操作地连接至控制元件的近端,从而使得控制元件在第一方向上的运动导致第一铰接电缆在第一方向上的运动及第二铰接电缆在第二方向上的运动;控制元件在第二方向上的运动导致第一铰接电缆在第二方向上的运动及第二铰接电缆在第一方向上的运动。
具体来说,参考图8及图9,当第一铰接电缆94b(即图8及图9中示出的下铰接电缆)经由轮92在近侧方向上被抽回时,如图9中箭头“D”所示,铰接电缆94b的固定至最远侧接头12a的远端绕转向节112b及U形件112c之间的交接面转动,从而使得沿着其侧表面在二者之间限定的间隙缩小。通过这样做,末端执行器组件100在向下方向箭头“B”的方向上被铰接,即在与纵轴“A-A”横向的方向上。为了使末端执行器组件100返回至未铰接状态或者使末端执行器组件100在相反方向上铰接,通过使轮92在相反方向上转动可以将铰接电缆94a(即图8及图9中示出的上铰接电缆)在近侧方向上抽回。
各种手柄和/或手柄组件可以与末端执行器组件100可操作地连接或关联,以实现其各个元件即驱动电缆142和/或铰接电缆94a、94b的操作及移动。在2006年10月5日提交的序列号为60/849,562、标题为“用于外科手术装置的程序控制的手柄组件”的美国临时申请以及于2006年10月5日提交的序列号为60/849,560、标题为“用于铰接式内窥镜器械的手柄组件”的美国临时申请中,公开了与末端执行器1100一起使用的示例性手柄和/或手柄组件,其全部公开内容通过引用合并于此。
图10及图11示出了一设想的实施例,其中电引线310a、310b、310c及311由电手术电缆310通过壳体20供给。具体来说,电手术电缆310穿过固定手柄50装进壳体20的底部。引线310c从电缆310直接延伸入转动组件80,并且连接至(经由熔丝夹或弹簧夹等等)驱动杆142以将第二电势传导至钳口部件120。引线310a及310b从电缆310延伸出并连接至手动开关或类似操纵杆的拨动开关400。
在一实施例中,开关400可以包括与壳体20(一旦装配)的外形相符的人体工程学尺寸的肘板405。可以设想,开关400允许用户选择性地在各种不同方位上激活手术镊10,即多方位激活。可以理解的是,这简化了激活。一对叉状物404a及404b向远侧延伸并与壳体20内设置的相应的一对机械接口21a及21b配合。肘板405与开关按钮402机械配合,开关按钮402依次连接至电接口401。电引线310a及310b电连接至电接口401。当肘板405被压下时,扳机引线311将第一电势传递至钳口部件110。具体来说,引线311从接口401延伸出、通过转动组件80、并沿着轴12的一部分最终连接至钳口部件110。引线310c直接连接至驱动轴142,驱动轴142最终连接至钳 口部件120,或者引线310c被配置为直接延伸至钳口部件120以传递第二电势。
可以设想,可以采用安全开关或电路(未示出)以使开关不能被起动,除非钳口部件110及120闭合和/或除非钳口部件110及120已经在其间夹持有组织。在后一种情况下,可以采用传感器(未示出)来判断其间是否夹持有组织。另外,也可以采用其它传感机构,其判断手术前、手术中(即在手术期间)和/或手术后状况。传感机构还可以与连接至电手术发电机的闭环反馈系统一起使用,以基于一个或多个手术前、手术中或手术后状况调整电手术能量。序列号为10/427,832的美国专利申请描述了一种这样的反馈系统,其全部内容通过引用合并于此。
如上所述,至少一个钳口部件,例如120,可以包括止挡部件750,止挡部件750限制两个对置的钳口部件110和120相对于彼此的运动。在一实施例中,根据特殊材料属性(例如抗压强度、热膨胀等等),止挡部件750从密封表面122延伸出预定距离以在密封期间产生一致且精确的间距“G”。可以设想,在密封期间对置的密封表面112及122之间的间距的变动范围为从大约0.001英寸至大约0.006英寸,更优选地,在大约0.002英寸至大约0.003英寸之间。在一实施例中,绝缘的止挡部件750模压在钳口部件110及120上(例如,二次注塑、注射成型等等),压印在钳口部件110及120上或者熔敷(例如,沉积)在钳口部件110及120上。例如,一种技术涉及将陶瓷材料热喷涂在钳口部件110及120的表面上以形成止挡部件750。一些热喷涂技术可以考虑,其涉及将大范围的抗热体及绝缘材料熔敷在各个表面上以形成止挡部件750用于控制导电表面112及122之间的间距。
图15至图21示出了在血管密封操作中使用的电手术铰接式手术镊1000的可选实施例。手术镊1000的上述许多特征与手术镊10的特征相似,为了一致性,这些特征在此合并到手术镊1000的以下讨论中,下面以较简化的形式讨论手术镊1000。
手术镊1000的操作与手术镊10相似,并且包括相对于固定手柄1050可活动的活动手柄1040。活动手柄1040可以选择性地绕一对枢轴1047及1057(见图14C)从相对于固定手柄1050的第一位置活动至更接近固定手柄1050的第二位置,如以下说明的这将使钳口部件1110及1120相对于彼此运动。每一枢轴1047及1057依次安装至相应的半壳体1020a及1020b。
手柄1040可操作地连接至一对联动杆1042及1045,在手柄1040运动时一对联动杆1042及1045将相应的运动传递至驱动组件1700,如以下将更详细地说明的。手柄1040及1050、枢轴1047及1057以及联动杆1042及1045的设置提供了优于常规手柄组件的明显机械优势,并且使用户能够获得类似杠杆的机械优势以致动钳口部件1110及1120。这减少了为实现组织密封而闭合钳口部件1110及1120所必需的机械力的总量。
与结合图1至图14所描述的实施例大部分类似,活动手柄1040的下端包括凸缘1044,凸缘1044包括安放在固定手柄1050中设置的预限定槽1051中的t形远端1044’。t形远端1044’相对于固定手柄1050锁定活动手柄1040,如以下将更详细地说明的。
末端执行器组件1100包括对置的钳口部件1110及1120,钳口部件1110及1120协作以有效抓紧组织用于密封目的。末端执行器组件1100被设计为单侧组件,即钳口部件1120相对于轴1012是固定的,而钳口部件1110绕枢轴销1134枢转以抓紧组织。具体来说,单侧末端执行器组件1100包括一个静止的或固定的钳口部件1120和枢转钳口部件1110,静止的或固定的钳口部件1120安装为与轴1012呈固定关系,枢转钳口部件1110绕连接在静止钳口部件1120上的枢轴销1134安装。往复式套筒1230滑动地设置在轴1012中,并且可由驱动组件1700远距离地操作。枢转钳口部件1110包括从钳口部件1110伸出而穿过往复式套筒1230中设置的孔口1232的棘爪或突出部1113(图14A)。通过套筒1230在轴1012中的轴向滑动来驱动枢转钳口部件1110,以使孔口1232的远端紧靠枢转钳口部件1110上的棘爪1113(见图16A至图17B)。向近侧拉动套筒1230使钳口部件1110及1120关于其间抓紧的组织闭合,而向远侧推动套筒1230使钳口部件1110及1120相对于彼此打开用于抓紧目的。
单侧末端执行器组件1100可以构造为,电能在突出部1113与套筒1230的接触点被输送通过套筒1230,或者利用“电刷”或杠杆(未示出)以在钳口部件1110闭合时接触活动钳口部件1110的后部。在这种情况下,电能将通过突出部1113被输送至钳口部件1110或1120中的一个。可选的,电缆引线1455可以被确定路径为向钳口部件中的一个例如钳口部件1120提供电压,而另一个电势可以通过套筒1230经由与引线1450的电触点传导(参照图16C)并且传送至枢转钳口部件1110,这在套筒1230缩回时建立了电连续。
钳口部件1110及1120包括分别与上述的钳口部件110及120类似的元件,诸如钳口绝缘器114及124以及导电密封表面112及122(见图13)。钳口部件1120还包括设置在导电密封表面1122的内侧端面上的一系列止挡部件750(见图16B),以利于组织的抓紧及操纵以及在密封和/或切开组织期间限定对置的钳口部件1110及1120之间的间隙“G”(见图17A)。可以设想,取决于特殊目的或为了达到期望的结果,可以在一个或两个钳口部件1110及1120上以各种构造设置这一系列止挡部件750。
铰接组件1090可操作地连接至壳体1020。铰接轮1090a及1090b可以设置为可选的配置,诸如设置在壳体1020的侧面。可以设想,轮1090a及1090b可由其它机构代替以致动诸如杠杆、轨迹球、操纵杆等的铰接组件1090。具体来说,如图18A至图18C对照示出的,当选择性的使轮1090a、1090b中的一个转动时,末端执行器组件1100可以从轴向对准状态(图18B)被铰接为铰接状态(图18C)。为了经由铰接组件1090铰接末端执行器组件1100,轮1090a及1090b被配置为在第一方向上转动使末端执行器组件1100在相应的第一方向上运动,而其在相反方向上转动使末端执行器组件1100在相反方向上运动。可以采用各种滑轮组件及齿轮组件以实现此目的。
例如,与上述铰接装置相类似,可以利用两条铰接电缆1094a及1094b来铰接轴1012的柔性部1012b。如图16C中最佳示出的,每一铰接电缆1094a及1094b包括可操作地与设置在轴1012的远端的末端执行器联结器组件1016连接的远端1094a’及1094b’。联结器组件1016包括限定在其中的空腔1225,空腔1225被配置为容纳一系列机械相互协作元件,这些机械相互协作元件被设计为接合驱动杆1142以使驱动杆1142在空腔1225中往复运动以及将各种电气接线(electrical connections)导引至钳口部件1110及1120。驱动杆1142优选地由柔韧的、减阻材料制成以允许驱动杆1142在手术镊1000被铰接时在指定方向上弯曲。减阻材料在铰接期间能够减少翘起。
联结器组件包括一对衬套1220及1240,衬套1220及1240接合驱动杆1142的远端1142’,并且经由销1231将驱动杆1142的远端1142’固定至驱动套筒1230。衬套1240滑动接合在驱动杆1142的接近远端1142’的顶部,而衬套1220被配置为接合衬套1240并将端1142’固定在衬套1220及1240之间。销1231将固定的衬套1240及1220以及驱动杆1142连接至驱动套筒 1230。当驱动组件1700致动时驱动套筒1230(及固定的驱动杆1142)被容纳在空腔1225中以在其中滑动平移,如以下将更详细地说明的。
联结器组件1016还包括锁定元件1210,锁定元件1210被配置为接合钳口部件1120的近端1117,以将联结器组件1016(及驱动杆1142)锁定在相对于钳口部件1120呈固定关系以限制二者间的任何转动运动。联结器组件1016还包括远侧凸缘1017,一旦装配,远侧凸缘1017支撑下钳口部件1120(见图14A)。如图16C最佳示出的,联结器组件1016还支撑引线1450与驱动套筒1230之间的电气接线。另外,联结器组件1016还导引穿过其中的电引线1455(虚线所示)以与钳口部件1110连接。
在操作中,铰接轮1090a及1090b之一的运动导致铰接电缆1094a及1094b在相反方向上的运动。具体来说,如图14C、图18A、图20A及图20B最佳示出的,铰接组件1090包括轮1090a及1090b,轮1090a及1090b啮合地连接至设置在壳体1020a及1020b相应侧上的对应的齿轮部件1096a及1096b(见图20A)。六边形轴杆1095被安装穿过两个齿轮部件1096a及1096b并且其两端被轮1090a及1090b覆盖。通过机械啮合表面(摩擦配合、几何形状配合等等)或者本领域中其它常规的方式将轴杆1095固定在齿轮部件1096a及1096b中。轮1090a及1090b的齿轮状设置允许铰接部件1090在指定方向上的逐齿分度,而且每一轮上的一对离合杆簧1091防止了轮在任一指定方向上的跳回。也就是说,离合杆簧1091被配置为与齿轮,例如齿轮1096b相互配合,并且允许在顺时针方向或逆时针方向上的逐齿推进(incrementaladvancement)。离合杆簧1091对齿轮例如齿轮1096b的偏置力足以将柔性轴1012b维持在任何期望的铰接位置。
轴杆1095将滑轮组件1600支撑在壳体1020中,滑轮组件1600与电缆1094a及1094b可操作地关联。具体来说,滑轮组件1600包括安装的两个滑轮1610a及1610b用于在轴杆1095上转动。每一滑轮1610a及1610b包括相应的导向筒1620a及1620b,导向筒1620a及1620b将各个电缆1094a及1094b导引在相应的滑轮1610a及1610b上以利于电缆1094a及1094b的往复运动。如图18A最佳示出的,电缆1094a被设计为接合滑轮1620b使滑轮1620b在一个方向上转动,而电缆1094b被设计为接合滑轮1620a使滑轮1620a在相反方向上转动。也可以理解为,这使得滑轮1610a及1610b能够以推拉方式操作以铰接柔性轴1012b。也就是说,当在P1方向上拉动一条电缆1094a时, 另一条电缆1094b被在P2方向上推动(或松弛)以允许在指定方向上铰接柔性轴1012b(见图18C)。导向筒1620a及1620b还预拉伸相应的电缆1094a及1094b以利于和增强柔性轴1012b的连续铰接。
如图14B最佳示出的,驱动组件1700还包括与驱动杆1142可操作地关联的精调组件1061,精调组件1061允许制造者在最后组装之前精细地调节钳口部件1110及1120相对于彼此的开口。具体来说,驱动杆1142连接至接合器1063,接合器1063依次连接至与驱动组件1700连接的驱动杆1142a,如以下描述的。接合器1063在其远端是带有螺纹的以螺纹接合调节旋钮1067,从而允许制造者精细地调节驱动杆1142相对于驱动组件1700的长度,因而使得能够精确并精细地控制钳口部件1110及1120的相对分离距离。
如图14C、图15A、图15B、图19A及图19B最佳示出的,驱动组件1700的致动允许用户选择性地打开和闭合钳口部件1110及1120以抓紧并密封组织。具体来说,驱动组件1700包括框架块1800,框架块1800可操作地安装压缩弹簧1740,压缩弹簧1740偏置驱动杆1142和联轴驱动杆1142a。联轴驱动杆1142a安装至驱动块1710,驱动块1710依次通过接合器1720连接至框架块1800的远端。当装配时,框架块1800被设置在限定在半壳体1020a及1020b中的对置的横档1021之间(见图14C),在手柄1040致动时横档1021允许框架块1800在壳体1020中运动。弹簧1740安装在衬垫1730(设置为邻接接合器块1720)及框架块1800的近端1810之间。驱动销1750安装至驱动块1710的相反的一端并支撑压缩弹簧1740以使驱动杆1142能够运动。
如上所述,手柄1040可操作地安装至驱动组件1700,以使手柄1040相对手柄1050的运动使驱动杆1142平移以打开或闭合钳口部件1110及1120。具体来说,手柄1040经由销1047在其顶部或远端被安装至连杆1045,连杆1045依次也经由销1047安装至框架块1800。手柄1040还在枢轴点1041安装至连杆1042,连杆1042依次在枢轴1057安装至手柄1050以完成四连杆机械组件。如图19A及图19B对照所最佳示出的,手柄1040朝向手柄1050的运动使两个连杆1042及1045转动以迫使框架块1800向近侧移动并且将驱动杆1142a向近侧拉动(这将驱动杆1142向近侧拉动)以闭合钳口部件1110及1120。同时,可操作地连接至手柄1040的底部的凸缘1044往复运动入限定在手柄1050中的导引槽1051,以使t形端部1044’将手柄1040锁定在相 对于手柄1050的适当位置。凸缘1044及通道1051以与上述手术镊10相似的方式操作。
弹簧1740包括设置在其中的两个对置的压缩盘1740a及1740b,压缩盘1740a及1740b滑动地安装在驱动销1750顶部。当手柄1040朝向手柄1050运动时,接合器1720的运动迫使弹簧盘1740a在驱动销1750顶部压紧并且将驱动杆1142向近侧拉动。如上所述,驱动杆1142向近侧的运动会导致驱动套筒1230接合钳口部件1110的凸缘1113并且使钳口部件1110相对于钳口部件1120闭合。然后凸缘1044依靠t形端部1044’将手柄1040相对于手柄1050锁定,t形端部1044’与限定在手柄1050中的止动凹槽(catch basin)1052接合。当手柄1040重新抓紧时,凸缘1044上的t形端部1044’重定向为离开通道1051以使手柄1040自由运动离开手柄1050。弹簧1740将手柄1040偏置在打开方位。
如上所述,钳口部件1120可以包括设置在导电密封表面1122的内侧端面上的一系列止挡部件750,以利于抓紧及操纵组织和在密封及切开组织期间限定对置的钳口部件1110及1120之间的间隙“G”(见图17A)。在导电密封表面1112及1122之间能够有效且可靠地密封组织的优选间隙“G”在大约0.001英寸至0.006英寸之间。取决于特殊钳口构造或期望的外科手术结果,止挡部件750可以沿导电钳口表面1112及1122以任意构造设置。
如图18A所示,末端执行器组件1100还可以在任一方向(见箭头“B-B”)上被铰接。一旦抓紧组织(在大约3kg/cm2至大约16kg/cm2之间的所需压力范围内),然后用户选择性地施加电手术能量以有效密封组织。一旦密封,然后用户可以通过致动扳机组件(未示出)选择性地推进刀具(未示出)以沿着组织密封切开组织。以上描述了一设想的刀具及扳机组件的操作特征及相关运动,序列号为10/460,926的美国专利申请也描述了这一设想的刀具及扳机组件的操作特征及相关运动,其全部内容合并于此。
类似上述的图2及图3,手术镊1000包括多个接头1312,接头1312嵌套串联排列以形成柔性轴1012b。远端或联结器组件1016与末端执行器组件1100机械接合,而轴1012的近端1014与壳体1020机械接合。柔性轴1012b的多个接头1312中的每一个包括远侧转向节1312a及一同形成的近侧U形件1312b。每一转向节1312a与邻接接头1312a的U形件1312b可操作地接合。每一接头1312具有限定在其中的中央内腔1317及形成在中央内腔1317两侧 上的一对对置的内腔1315a及1315b。铰接电缆1094a及1094b可滑动地贯穿接头1312的相应的内腔1315a及1315b。上文已描述过了电缆1094a及1094b的操作。铰接电缆1094a及1094b优选地由柔性的、减阻材料制成。
还包括开关2000,其与壳体1020(一旦装配)的外形相符。可以设想,开关2000允许用户选择性地在各种不同方位上激活手术镊1000,即多向激活。可以理解为,这简化了激活。按钮开关2010向远侧延伸并与肘板2015接合(见图15B),肘板2015依次连接至电接口或PC板(未示出)。设置在电缆2020内部(见图19)的电引线2025a及2025b电连接至电接口或PC板。当按钮开关2010被压下时,引线2025a及2025b将电势传递至钳口部件1110及1120。
可以设想,可以采用安全开关或电路(未示出)以使开关不能被起动,除非钳口部件1110及1120闭合和/或除非钳口部件1110及1120已经在其间夹持有组织。在后一种情况下,可以采用传感器(未示出)来判断其间是否夹持有组织。另外,可以采用其它传感机构,其判断手术前、手术中(即在手术期间)和/或手术后状态。传感机构还可以与连接至电手术发电机的闭环反馈系统一起使用,以基于一个或多个手术前、手术中或手术后状态调整电手术能量。序列号为10/427,832的美国专利申请描述一个这种反馈系统,其全部内容通过引用合并于此。
各种手柄和/或手柄组件可以与末端执行器组件1100选择性地连接或关联,以实现其各个元件即驱动杆1142和/或铰接电缆1094a、1094b的操作及移动。在2006年10月5日提交的序列号为60/849,562标题为“用于外科手术装置的程序控制的手柄组件”的美国临时申请以及于2006年10月5日提交的序列号为60/849,560、标题为“用于铰接式内窥镜器械的手柄组件”的美国临时申请中,公开了与末端执行器1100一起使用的示例性手柄和/或手柄组件,其全部公开内容通过引用合并于此。
通过上述描述及参考各个附图,本领域技术人员可以理解的是,还可以在不脱离本公开的范围的情况下对本公开做某些改进。例如,可以考虑手术镊10(和/或与手术镊10关联使用的电手术发电机)可以包括传感器或者反馈机构(未示出),传感器或者反馈机构自动选择适当量的电手术能量以有效密封抓紧在钳口部件110及120之间的特定尺寸的组织。传感器或反馈机构还可以测量在密封期间穿过组织的阻力,并提供在钳口部件110及120之间 已经产生了有效密封的指示(视觉的和/或音响的)。2003年5月1日提交的序列号为10/427,832、标题为“用于控制射频医用发生器的输出的方法及系统”的共有的美国专利申请中描述了这种传感系统的示例,其全部内容通过引用合并于此。
可以理解为,将开关400、2000设置在手术镊10、1000上具有很多优点。例如,开关400、2000减少了操作空间中电缆的总量并且消除了在外科手术过程中由于“视线”作用而致动了错误器械的可能性。而且,可以设想,在激活刀具185期间可以使开关400、2000停止运作。当扳机被驱动时停止运作开关400、2000,这消除了在切割过程中无意的驱动手术镊10、1000。还可以设想,开关400、2000可以设置在手术镊10、1000的另一部分上,例如手柄40、1040、转动组件80、壳体20等等上。
另一个设想的安全机构可使电缆引线中的一个确定路径为以向一个钳口部件例如钳口部件1120提供电压,另一电势可以传导通过环绕驱动杆1142的驱动套筒例如驱动套筒1230并传导至另一钳口部件1110,以仅在驱动套筒缩回时建立电连续。可以设想,这个特定设想的实施例将提供至少一个附加安全特征,即仅当钳口部件1110及1120闭合时形成到钳口部件1110及1120的电连续。驱动杆1142还被供给第二电势并包括相似类型的安全机构。
在一设想的实施例中,手术镊10、1000可以不包括刀具185,而该器械被设计为仅用于密封血管或其它组织束。在此情况下,凸轮毂144(仅关于手术镊10)可被转动以铰接末端执行器组件100,而且可以去除电缆94a及94b。
在一实施例中,两个绝缘的电引线可以向相应的钳口部件110及120(或者1110及1120)供给电能。在此情况下,可取的是,可以沿着轴12、1012的外侧设置通道,该通道将电引线从壳体20、1020导引至单独的钳口部件110、120(或者1110及1120)。可以利用一个或多个引线夹头等以将电引线保持在适当的位置。可选的,可以利用电缆94a及94b(或者1094a及1094b)两者铰接末端执行器组件100(或1000)和将电能供给至钳口部件110及120(或者1110及1120)。
尤其在手术镊10中,但并不局限于手术镊10,电缆引线例如手术镊10的电缆引线311沿着电缆轨道松弛但是牢固的被夹持以允许钳口部件110绕枢轴103转动。由于环绕电缆引线311的绝缘护套,两个电势被彼此绝缘。 而且,轴12的近侧部可以为刚性的或基本刚性的,而远侧部为柔性的和/或按照以上详述地方式进行铰接的。可选地,整个轴12可以是柔性的。更进一步,可以阻止扳机组件70的起动,直到活动手柄40在近侧被锁定(或简单运动)以使钳口部件110及120闭合。
在关于手术镊10、1000的实施例中,钳口部件110、120及1110、1120的导电密封表面112、122及1112、1122分别是相对扁平的以避免电聚集在尖缘处和避免高点之间的电弧。另外,由于组织被接合时组织的反作用力,钳口部件110、120及1110、1120可以被制造为抗弯。例如,钳口部件110、120及1110、1120可以沿其宽度逐渐变细,其由于组织的反作用力抵抗了弯曲。
可以设想,末端执行器组件100、1100的外表面可以包括设计为在致动及密封期间减少钳口部件110、120及1110、1120与周围组织之间的粘连的镍基材料、镀层、冲压件、金属注塑模具。而且,还可以考虑的是,钳口部件110、120及1100、1120的导电表面112、122、及1112以及1122分别可以由以下材料中的一种(或者一种或多种结合)制造:镍铬合金、氮化铬、由俄亥俄州(OHIO)的Electrolizing公司生产的MedCoat2000、inconel600及锡镍。组织导电表面112、122及1112以及1122还可以涂有一种或多种上述材料以达到相同的效果,即,“不粘性表面”。可以理解为,减少密封期间组织“粘着”的量提高了器械的整体功效。
此处公开的一类特定的材料已经显示出了优良的不粘结特性,在一些情况下还具有优良的密封特性。例如,包括但不限于:TiN、ZrN、TiAIN及CrN的氮化物涂层是用于不粘性目的的优选材料。CrN由于其整体表面特性及最佳的性能已经发现其对于不粘性目的是尤其有效的。还发现其它类别的材料可以降低整体粘性。例如,已经发现Ni/Cr比接近5∶1的高镍/铬合金可以显著地降低双极仪器的粘性。此类别中一种尤其有效的不粘材料为Inconel600。具有由Ni200、Ni201(~100%Ni)制造的或涂有这些材料的密封表面112、122及1112以及1122的双极仪器还显示出了相比典型的双极不锈钢电极改进的不粘性能。
手术镊10、1000可以设计为其取决于特殊目的或为了达到特殊结果而完全或部分地可置换。例如,末端执行器组件100、1100可以与轴12、1012的远端选择性地及可拆卸地接合,和/或轴12、1012的近端14、1014可以与 壳体20、1020选择性地及可拆卸地接合。在上述两个情况的任一个中,手术镊10、1000被认为是“部分可置换的”或“可有限次使用的(reposable)”,即需要时,新的或不同的末端执行器组件100、1100(或者末端执行器组件100、1100及轴12、1012)选择性地替代旧的末端执行器组件100、1100。可以理解为,目前公开的电气接线需要改变以将器械改装为可有限次使用的手术镊。
尽管附图中示出了本公开的一些实施例,但本公开并不旨在被限制在这些实施例内,因为本公开旨在涵盖本领域允许的较大范围,说明书也是如此。因此,以上描述不能视为对本发明的限制,仅为特殊实施例的示例。本领域技术人员可以在所附权利要求的范围和精神内设想其它变化。
Claims (12)
1.一种用于处理组织的电手术器械,包括:
壳体,其具有从其中延伸出的轴,且穿过所述轴限定了轴线(A-A),所述轴至少部分是柔性的并且包括连接在其远端的第一和第二钳口部件,每个钳口部件包括适于连接到电手术能量源的导电组织接触表面,以使所述导电组织接触表面能够通过夹持在所述第一和第二钳口部件之间的组织来传导电手术能量;
驱动组件,其设置在所述壳体中并且包括第一致动器,所述第一致动器可操作地连接到驱动杆以使驱动杆往复运动,其中所述第一致动器的致动使所述驱动杆往复运动,所述驱动杆依次将所述第一和第二钳口部件从彼此呈隔开关系的第一位置移动到彼此更靠近的第二位置以咬合组织;以及
第二致动器,其设置在所述壳体上并且可致动以使所述第一和第二钳口部件在轴向对准状态和铰接状态之间进行运动,其中在轴向对准状态中所述第一和第二钳口部件与所述轴线(A-A)对准,在铰接状态中所述第一和第二钳口部件在与所述轴线(A-A)横向的方向上被铰接。
2.根据权利要求1所述的用于处理组织的电手术器械,其中所述轴的柔性部分包括嵌套地串联排列的多个接头。
3.根据权利要求2所述的用于处理组织的电手术器械,其中每个接头包括穿过其限定的至少一个内腔以允许所述驱动杆在其中往复运动。
4.根据权利要求2所述的用于处理组织的电手术器械,其中每个接头包括在其中形成的中央内腔和在所述中央内腔的两侧形成的一对对置的内腔,其中所述电手术器械包括可滑动地贯穿相应的对置的内腔的一对铰接电缆,所述一对铰接电缆相对于彼此可活动以相对于轴线(A-A)铰接所述轴的柔性部分。
5.根据权利要求1所述的用于处理组织的电手术器械,其中所述驱动杆是柔性的。
6.根据权利要求1所述的用于处理组织的电手术器械,其中所述第二致动器包括铰接组件,所述铰接组件具有至少一个用户致动元件,所述用户致动元件设置在所述壳体上并且可操作地连接到滑轮系统上以使一对铰接电缆可滑动地贯穿所述轴往复运动。
7.根据权利要求6所述的用于处理组织的电手术器械,其中所述铰接组件包括至少一个导引件,所述导引件用于将所述一对铰接电缆导引到所述滑轮系统中并且用于预拉伸所述铰接电缆。
8.一种用于处理组织的电手术器械,包括:
壳体,其具有从其中延伸出的轴,且穿过所述轴限定了轴线(A-A),所述轴至少部分是柔性的并且包括连接在其远端的第一和第二钳口部件,每个钳口部件包括适于连接到电手术能量源的导电组织接触表面,以使所述导电组织接触表面能够通过夹持在所述第一和第二钳口部件之间的组织来传导电手术能量;
驱动组件,其设置在所述壳体中并且包括可操作地连接到驱动杆以使驱动杆往复运动的四杆机械联动杆,其中所述四杆机械联动杆的致动使所述驱动杆往复运动,所述驱动杆依次使所述第一和第二钳口部件从彼此呈隔开关系的第一位置移动到彼此更靠近的第二位置以咬合组织;以及
第二致动器,其设置在所述壳体上并且可致动以使所述第一和第二钳口部件在轴向对准状态和铰接状态之间进行运动,其中在轴向对准状态中所述第一和第二钳口部件与所述轴线(A-A)对准,在铰接状态中所述第一和第二钳口部件在与所述轴线(A-A)横向的方向上被铰接。
9.一种用于处理组织的电手术器械,包括:
壳体,其具有从其中延伸出的轴,且穿过所述轴限定了轴线(A-A),所述轴至少部分是柔性的并且包括连接在其远端的第一和第二钳口部件,每个钳口部件包括适于连接到电手术能量源的导电组织接触表面,以使所述导电组织接触表面能够通过夹持在所述第一和第二钳口部件之间的组织来传导电手术能量;
驱动组件,其设置在所述壳体中并且包括可操作地连接到驱动杆以使驱动杆往复运动的第一致动器,其中所述第一致动器的致动使所述驱动杆往复运动,所述驱动杆依次将所述第一和第二钳口部件从彼此成隔开关系的第一位置移动到彼此更靠近的第二位置以咬合组织;
第二致动器,其设置在所述壳体上并且可致动以铰接所述轴;以及
调节致动器,其连接到所述驱动杆上,允许制造者调节当所述第一和第二钳口部件处于第一位置时的所述第一和第二钳口部件的相对距离。
10.根据权利要求9所述的用于处理组织的电手术器械,其中轴的柔性部分包括嵌套地串联排列以形成柔性轴的至少一部分的多个接头,其中每个接头包括在其中形成的中央内腔和在所述中央内腔的两侧形成的一对对置的内腔,其中所述电手术器械包括可滑动地贯穿相应的对置的内腔的一对铰接电缆,所述一对铰接电缆相对于彼此可活动以相对于轴线(A-A)铰接所述轴。
11.根据权利要求9所述的用于处理组织的电手术器械,其中所述第二致动器包括铰接组件,所述铰接组件具有至少一个用户致动元件,所述用户致动元件设置在所述壳体上并且可操作地连接到滑轮系统上以使一对铰接电缆可滑动地贯穿所述轴往复运动。
12.根据权利要求11所述的用于处理组织的电手术器械,其中所述铰接组件包括至少一个导引件,所述导引件用于将所述一对铰接电缆导引到所述滑轮系统中并且用于预拉伸所述铰接电缆。
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