CN101237808A - 内镜治疗方法以及包括组织闭塞装置的相关外科组件 - Google Patents

内镜治疗方法以及包括组织闭塞装置的相关外科组件 Download PDF

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CN101237808A
CN101237808A CNA2006800287062A CN200680028706A CN101237808A CN 101237808 A CN101237808 A CN 101237808A CN A2006800287062 A CNA2006800287062 A CN A2006800287062A CN 200680028706 A CN200680028706 A CN 200680028706A CN 101237808 A CN101237808 A CN 101237808A
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window
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hemorrhoid
ducted body
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格雷戈里·皮斯孔
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HET Systems Ltd.
Mike, Plata, Limited by Share Ltd.
Covidien LP
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Abstract

一种外科器械包括中空件和关闭件,中空件具有带窗口的侧壁,关闭件可移动地连接到中空件,以便可选择地覆盖和不覆盖窗口。中空件具有沿窗口的棱边的第一夹紧表面,而关闭件具有与第一夹紧表面相对、并在器械的夹紧或关闭结构中被配置成基本与第一夹紧表面相邻的第二夹紧表面。该器械另外包括组织闭塞部件,该组织闭塞部件安装在中空件和关闭件的至少之一上,用于作用在紧夹于第一夹紧表面和第二夹紧表面之间的组织上以使组织相互结合。

Description

内镜治疗方法以及包括组织闭塞装置的相关外科组件
技术领域
本发明涉及外科治疗人体内侧的组织块(tissue masses),尤其涉及沿如结肠之类的中空的内部器官的壁的组织块的外科治疗。本发明尤其可用于但不专用于痔的治疗。更具体地说,本发明还涉及痔的治疗方法,其中痔的基底被夹紧器械的钳夹压缩,然后通过施加撞击或能量堵塞(occluded)痔的血管供应。本发明还涉及被设计成能实现此任务的器械组件。
背景技术
在人或动物体内可能存在多种局限于中空器官的内衬内的异常情况。结肠息肉、肠动静脉型血管畸形、内皮血管损伤、静脉瓣异常、及复杂的内痔就是几个实例。其他情况可包括在结肠穿孔、恶性肿瘤的侵害等中的中空器官的壁的整个厚度。由于基本上避免了外科切口(access)创伤,处理这些异常情况的内镜方法(endoluminal approach)对于患者来说好处非常大。
使用内镜方法能够相对简单地进行治疗的一种常见情况是复合痔。传统的治疗这些病的方法是采用各种介入和非介入内镜方法。紧邻外口的内痔可以相当方便地进入。下面对市面上可用的几种技术进行回顾。当然,它们具有涉及费用、技术复杂性和/或低临床疗效等公知的局限性。
痔类疾病是非常常见的疾病,50岁左右人群的一半以上都受其困扰。美国每年大约500,000患者接受一种或其他类的介入治疗来治疗有症状的痔疮。美国一年约有160,000患者接受痔的外科切除术。
术语“痔”通常用来指涉及肛门和直肠下端的血管复合体的令人烦恼的肛门周围的症状。这种症状通常与引起血管组织自然增大有关,还可能并发出血、下垂、血栓、骚痒、烧灼感(burning)等。“痔”这个词源于希腊语“haimorrhoos”(haimo-hemo+rhein-to flow),其意思是“随血液流动(flowing with blood)”。词“Pile”是痔的同义字,其源自拉丁语“pila”-“ball”。
由于便秘引起的反复弯曲(straining)看来是痔形成和发展的主导因素。具有痔症状的几率随年龄、妊娠、肥胖、沉积时间(sedimentary life)、提起重物和遗传因素而增加。
所谓齿状线(dentate line)将直肠与肛门任意地分开。直肠黏膜没有疼痛受体。因此,限于直肠黏膜的那些治疗步骤(procedures)患者通常不感到疼痛。反之,肛门黏膜含有很多疼痛受体,因此,对疼痛刺激非常敏感。位于直肠内的痔称为内痔。内痔位于黏膜下层的层内。外痔则位于肛门内。内痔和外痔通常具有不同的临床表现和并发症。内痔易于在肛环外侧出血和脱垂。脱垂的内痔很容易由痉挛的肛门括约肌导致创伤和绞窄(strangulate)。外痔可破裂,在肛门周围区域引起疼痛的皮下肿块,这经常被称为形成血栓的外痔(thrombosed external hemorrhoids)。外痔血栓可导致外层组织溃烂和出血。两种痔均可引起肛门周围不适、骚痒、有刺激作用、妨碍肛门周围卫生、损失工作时间及使生活质量明显下降。
可根据痔的类型和严重性制定治疗方案。众所周知,针对排便调节和症状缓解的药物治疗只具有临时的和经常是不完全的效果。当前的介入治疗、非切除疗法被设计成消除对部分痔或整个痔的血液供应(橡胶带结扎法、红外凝血、注射硬化疗法、超声波制导痔动脉结扎术)。这些方法临床疗效不大,不稳定且经常复发。
在美国,橡胶带结扎法是最流行的用来治疗痔的方法。Blaisdell于1963年曾描述过这种技术。此方法速度快且不贵。在此手术中,将一些痔组织拉到结扎器内,且围绕被拉出组织的基底设置橡胶带。这种方式主要使供给内痔的一部分及其上所覆的直肠黏膜的血液绞窄。痔的自动切断和缺血性坏死要经历几天,留有需几天才能愈合的敞开的直肠伤口。影响日常行动的明显的术后疼痛是很罕见的,而且可能与将橡胶带放置在太靠近齿状线(疼痛敏感区)有关。虽然橡胶带结扎法对于较小的内痔出血的立即控制非常有效,但对单一的较大的痔来说,常常需要多次治疗以减小基本尺寸。由于痔的明显的部分通常没有去除,复发是常事。另外,由于这种治疗法使患者的肛门在几天或数周内有敞开的伤口,橡胶带结扎法不适用于爱滋病病毒为阳性的患者,且对于有遗传性的、后天性的以及医源性凝血症的患者来说需要更加严格的准备。
硬化疗法是另一种治疗一和二度内痔的方法。通过与注射器联接的单一的细针头可注入硬化剂,且力图注入血管腔内。由于痔基本上是多个扭绞的血管管腔组成的球体,基本上不可能理想地准确注入硬化剂。其并发症和复发率非常高。
超声波制导痔动脉结扎术包括对包含了痔动脉的直肠组织的人工缝合。通过超声波定位动脉。期望对应内痔所引起的退化。由于缝合结扎在疼痛非敏感区内在内痔上方完成,手术过程是无痛的。这种技术要求苛刻且极依赖于手术人员的经验和灵巧性。没有经验和技术不熟练都可能引起“错过”痔动脉和疏忽直肠和血管损伤的后果。也有能引起严重出血的痔动脉损伤、直肠壁损伤等的相关报道,而且经常复发。
痔动脉的红外凝血包括将红外凝血能量输送到痔动脉、随后引起对应的内痔退化。由于不知动脉的准确位置而只是推测其位置靠近内痔,需要几次盲目的红外发射来提高到达隐蔽目标的几率。推荐的做法是花费几星期的时间进行几个治疗疗程。由于红外探头和黏膜之间的界面模糊,红外探头的正确使用在治疗较大的痔时是很困难的。复发也很频繁。
上面所描述的技术中没有一种适当地致力于经常伴随着痔疾病的发展阶段(随后的第二,第三和第四阶段)的组织冗余和组织脱垂,因此上述技术被认为只适用于内痔的第一阶段和第二阶段的前期治疗。尽管如此,复发的几率是确实的,这反映出现有方法的不足。
现已发现的被认为是能有效地长期控制痔症状的唯一方法是对痔施行外科切除术。内痔的外科切除有两种主要方法:传统的外科切除术(纵向痔切除术)和所谓的用于脱垂和痔疮的(治疗)常规和方法或PPH(Procedurefor Prolapse and Hemorrhoids)(吻合器痔环状切除术)。
用传统外科切除术治疗痔非常有效,但却是使人虚弱无力的治疗方式。其基本以纵向方式向下切除痔组织直到内括约肌下面。传统的外科切除术几乎不变地将肛门创伤延伸至并超过齿状线,因此导致严重的术后疼痛。这种技术极大地依赖于操作人员的技术。痔的外科切除术需要麻醉,而且严重的肛门周围疼痛延达数周之久并显著损失工作时间。
所谓的脱垂和痔疮的(治疗)常规和方法(PPH)包括使用圆形吻合器对靠近内痔的直肠黏膜和黏膜下层的层施行环行切除。这种手术基本涉及痔的径向血行阻断而痔组织本身留下,使之局部缺血性退化。由于切除是在疼痛非敏感区(齿状线上方)内进行,与传统痔切除术相比,可观察到术后疼痛减轻和恢复更快。据称术后内痔在四到六周内萎缩。PPH的提倡者声称疼痛更轻和恢复更快,但是这种技术需要麻醉且对技术和器械配置有要求。另外,这种技术形成基本为圆周的直肠创伤,而这种圆周的直肠创伤在大多数情况下只是一或两痔增大时明显过大。也有出现严重并发症的报道。肛管的基本呈圆周的创伤和随后的瘢痕可导致直肠狭窄(变窄),而这将导致病人虚弱无力并很难治疗。这种技术要求大面积的肛门扩张以容纳圆形吻合器的大的头部组件,这本身就存在术后肛门不适的附加原因和可能的肛门创伤(肛裂、出血等)。PPH技术与传统痔切除术相比,其主要优点是以横向方式使手术损伤线处于齿状线上方。
总之,虽然已提出了很多微创技术治疗症状明显的内痔,但这些方法都具有高复发率并需要反复手术。约15-20%的正接受介入治疗法以治疗他们的内痔的患者需要施行痔切除术,主要是因为当前的非切除技术没有致力于对伴随的肛门黏膜脱垂和组织冗余(redundancy)或对这些病症付出的努力不够(橡胶带结扎法)。一些患者群、例如爱滋病病毒呈阳性的患者、脊髓损伤的患者、及凝血病患者等对于这些现有技术具有绝对或相对的禁忌证。脱垂和痔疮的(治疗)常规和方法致力于克服现有技术的诸多不足,但这种技术对技术和器械配备有一定要求,要求全身或局部麻醉,对其的设计导致产生经常的不必要的圆周直肠损伤。
因此,需要一种可更快和更有效地以微创的方式(良性组织不受伤害)和以无疼的方式(切除线处于齿状线上方)治疗痔的设备。
发明内容
本发明旨在提供一种用于外科治疗位于沿如结肠之类的体内器官或内腔的壁的内部组织的改进方法和相关器械。该方法和器械优选用于痔组织的治疗,其对身体的创伤比现有的用于痔疮的外科治疗方法和器械小。本器械包括可在实现本发明的方法中使用的肛门镜,还包括组织闭塞装置(tissue occlusion device)。这些器械一起形成用于治疗具有任何增大和脱垂的严重性的一或多痔的外科器械组件。本发明另外还关注用于可在办公室而不需要在手术室(对痔进行适当治疗的器械。更一般地说,本发明旨在提供一种方法和/或相关的器械组件,其可与内窥镜一起使用以便接近天然体(natural body)内腔内距离天然体口端很远的外科部位。
本发明的一部分还提供一种用于痔疮治疗的装置和相关方法。该装置也能用于其他在远离天然体口端部位上的其他病变的治疗。因此,本发明的一部分关注于内镜介入组件,其包括用于将器械输送和支撑(光学的和机械的)到远离天然口端(natural openings)的外科部位的附件系统。
根据本发明,外科器械包括:具有设有窗口的侧壁的中空件和关闭件,该关闭件可运动地连接到中空件,用于可供选择地覆盖和不覆盖窗口。中空件具有沿窗口棱边的第一夹紧表面,而关闭件具有与第一夹紧表面相对的第二夹紧表面,在器械的夹紧或闭合结构中可将该第二夹紧表面配置(disposable)成大致与第一夹紧表面相邻。该器械另外还包括组织闭塞部件,该组织闭塞部件被安装在中空件和关闭件的至少之一上,用来作用在被夹紧于第一夹紧表面和第二夹紧表面之间的组织上以使这些组织相互结合。
在本发明的一内窥镜实施例中,中空件具有用于接收内窥镜的插入件的通道,该中空件包括相对于通道为横向的室,窗口与室相通。关闭件可滑动地插入中空件中的另一通道内。中空件可具有多个用于允许从中空件外侧目视观察该室的光线进入口。在这种情况下,中空件或内窥镜可设有如光纤束之类的导光部件,以便将照度传递到室内,并用于将图象从室中传送到如视频监视器或目镜之类的观看器。还可在内窥镜的中空件中设有在远端与室相通、能使内窥镜器械的顶端插入室内的一或多条工作通道。
根据本发明的另外的特征,中空件的侧壁是弯曲的且第一夹紧表面和第二夹紧表面的至少之一具有弯曲的形状,例如,C型或U型。
关闭件可滑动地连接到中空件时,在关闭件的开启和关闭过程中,第一夹紧表面和第二夹紧表面可基本保持相互平行。此外,中空件具有纵向轴线,第一夹紧表面和第二夹紧表面可在取向基本垂直于该轴线的平面上延伸,而关闭件可平行于该轴线运动。
在本发明一可供选择的实施例中,中空件具有通道,关闭件被部分地设置在该通道内,而窗口与通道相通。
依照本发明一实施例,中空件的一端封闭并在相对端设有把手。也可在关闭件的与第二夹紧表面相对的那端设有与把手平行延伸的握柄。
组织闭塞部件可以是吻合器机构、可连接到盛有硬化剂的贮存器上的注射机构、或可连接到激光辐射源上的光纤。对于本领域技术人员来说,其他类型的组织闭塞装置是显而易见的。
本发明的外科器械包括限定出纵向通道的中空体,该中空体的近端至少部分地开启,中空体具有侧壁,该侧壁设有与近端分隔开的窗口。本外科器械还包括遮板或关闭件,该遮板或关闭件可运动地安装到中空体上,用于在将中空体定位于体腔内的过程中覆盖窗口,可将遮板或关闭件从窗口移开以允许器官组织通过窗口突出。
窗口可位于器械的中空体侧壁的凸出部分中。
在本发明的一特别适用于内窥镜的实施例中,(a)中空体具有设于凸出部分中的室,(b)窗口与室相通,(c)中空件被构成为具有将通道与室分隔开的隔离部分,以及(d)通道的尺寸被确定为用于接收内窥镜的插入件。因此,在本发明此实施例中,器械被设计成用于结合到内窥镜上,以便与内窥镜的远端部分一起插入患者体内。遮板或关闭件可滑动地设置在中空体内。
本发明的外科方法利用一种器械组件,该器械组件包括具有形成有窗口的侧壁的中空体件,而且还包括组织闭塞部件,该闭塞部件限定一对钳夹,至少一个钳夹包括弓形的夹紧表面。本方法包括:(i)将中空体件插入患者的体腔内,(ii)操纵中空体件,使器官组织通过窗口突出到中空体件内,(iii)在组织通过窗口突出后,操纵闭塞部件使得钳夹位于突出组织的相对侧,(iv)然后闭拢钳夹,以夹紧突出组织,以及(v)随后操作闭塞部件,以使突出组织的一部分永久缢缩(constrict)。
在器械组件包括用于覆盖窗口的遮板或关闭件的情况下,将中空体件插入体腔的步骤通常包括在遮板或关闭件覆盖窗口时将中空体件插入,同时该方法还包括运动遮板或关闭件以便不覆盖窗口而使器官组织通过窗口突出。
遮板或关闭件的运动可包括相对于中空体件滑动遮板或关闭件。
该方法可另外包括将中空体件联接到内窥镜的插入件上,使得将中空体件插入体腔内的步骤包括将内窥镜与联接到其上的中空体件一起插入体腔内。
在中空体件具有通道和室、窗口与室相通的状况下,将中空体件联接到插入件包括将内窥镜的插入件插入中空体件的通道内,而该方法还包括通过具有进入所述室的光学系统来目视观察室内的突出组织。
本发明提出通过具有正常尺寸或任何扩大和突出程度的肛门插管对一或多痔施行微创治疗。本发明的方法推荐在所谓齿状线(齿状线是肛管内的解剖学线,在其上方黏膜对疼痛不敏感)上方沿横向方向(相对于肛门轴)应用吻合器线。由于本发明的闭塞装置内的组织闭塞钳夹的C形弯曲基本呈圆形截面,本方法可保持圆形吻合器的所有优点而不存在所述缺点。在不存在可能的直肠狭窄或大致伴随的肛门直肠创伤的情况下,如果需要,可将具有不同C弯曲程度(较大或较小弯曲)的较小吻合器盒或钳夹用于较小的痔或用于不同的直肠,美国专利6,142,933中附带公开了这种方法。本发明的特殊的肛管口或肛门镜设计与具有C弯曲的吻合器钳一起可在不出现不必要的外科创伤和开支的情况下治疗选定数量的痔。本发明的肛门镜和组织闭塞装置可在没有受过训练的医护人员的帮助下在办公室内使用。特别是在痔的治疗中,外科创伤较小,可减小工作损失和减少正常生活的中断。
附图说明
图1为用于本发明方法的本发明的肛门镜的部分剖切的示意性透视图,其示出了一对钳夹;
图2为用于本发明方法的本发明的组织闭塞装置的部分剖切的示意性透视图;
图3为图1所示钳夹的近侧的一个的示意性透视图,其示出了组织闭塞机构的细节;
图4为图1所示的近侧钳夹的示意性透视图,其示出了另一组织闭塞机构的细节;
图5为图1所示的近侧钳夹的示意性透视图,其示出了又一组织闭塞机构的细节;
图6为图1所示的近侧钳夹的示意性透视图,其示出了再一组织闭塞机构的细节;
图7A-7F为插入到肛管内的图1所示的肛门镜的横截面示意图,其示出了本发明方法的步骤顺序;
图8为沿图7D中线IX-IX剖切的横截面示意图;
图9为沿图7C中线VIII-VIII剖切的横截面示意图;
图10为图1和图7A-7F中的肛门镜的横截面简图;
图11为与图10类似的横截面简图,其示出了图1和图7A-7F中的肛门镜的一种可供选择的设计;
图12为与图10类似的横截面简图,其示出了图1和图7A-7F中的肛门镜的另一种可供选择的设计;
图13为本发明的包括了组织闭塞部件的肛门镜的侧视图;
图14为图13所示的组织闭塞肛门镜的底部、正面和左侧透视图;
图15为图13和14所示的组织闭塞肛门镜的顶部、后面和左侧透视图;
图16为图13-15所示的组织闭塞肛门镜沿纵向或轴向部分的顶部、后部、和左侧透视图;
图17为图13-16所示的组织闭塞肛门镜的纵向截面图,其示出了处于开启或组织接收位置的遮板或关闭件;
图18为与图17类似的视图,其示出了处于关闭或未夹紧位置的遮板或关闭件;
图19为本发明的内窥镜组织闭塞件的一实施例的示意性顶视图;
图20为图19所示的内窥镜组织闭塞组件的示意性底视图;
图21为图19和20所示的组织闭塞组件沿图19中线XXI-XXI剖切的纵向截面示意图;
图22为图19-21所示的组织闭塞组件沿图20中线XXII-XXII剖切的横截面示意图;
图23为本发明的内窥镜组织闭塞组件的另一实施例的示意性底视图;
图24为图23所示的组织闭塞组件沿图23中的线XXIV-XXIV剖切的纵向截面示意图。
具体实施方式
如图1所示,用于痔外科的肛门镜20包括中空体22和遮板件24。中空体22限定出纵向通道或内腔26,该通道或内腔在远端28处封闭而在近端32形成开口30。开口30可目视观察外科部位和器械的插入。中空体22具有侧壁34,该侧壁设有与远端28分隔开、优选也与中空体22的近端28分隔开的矩形窗口36。
遮板件24可运动地安装在中空体22上,以便在将肛门镜20定位于肛管内的过程中覆盖窗口36。可将遮板件24从窗口36移开,以允许痔组织通过窗口36突出到肛门镜通道26内。更具体地说,遮板件24可滑动地安装于中空体22上并设置在中空体22内,且具有与窗口36周围区域内的侧壁34一致的形状。
遮板件24位于中空体内的轨道37中。轨道37采用浅凹陷或凹进的方式并具有起导引遮板件24滑动的作用的纵向棱边或台肩39。在插入过程中横向棱边或台肩41起与遮板24连续的远端运动邻接的作用。例如,可将遮板件24通过纵向棱边或台肩39内的凹槽(未示出)锁定于轨道37中。
中空体22通常具有纵向轴线38,侧壁34被形成为带有凸出部分或突起40,该凸出部分或突起位于轴线一侧上,并从中空的肛门镜体的近端32部分地沿侧壁34的长度朝远端28延伸。窗口36位于凸出部分40内,遮板件24可沿凸出部分40滑动并与其嵌合。如图8和9所示,将遮板件24和凸出部分40形成为可协同作用,致使凸出部分起可滑动地保持遮板件的轨道的作用。通常可使窗口36具有任何适用于突出的痔组织HT(图7B-7F,8和9)进入的形状。可以是矩形和圆形形状。
肛门镜20的中空体22具有围绕近端32处的开口30的边缘42。优选中空体22沿边缘42设有凸缘44,该凸缘起止动作用以阻止肛门镜20完全滑入肛管内。沿中空体22的边缘42还设有切口46,该切口被设置在与凸出部分40相对的轴线38的那一侧。切口46有利于操作任何被插入肛门镜20内对痔组织施行手术的器械。另外,切口46便于观察窗口36和通过窗口36观察突出到纵向通道26内的痔组织HT。
在某些应用中,窗口36可沿近侧方向一直延伸到凸缘46。在任何情况下,窗口36应大到足以允许痔进入肛门镜20的内腔或通道26内。窗口36处于凸出部分或突起40内,有利于为窗口36提供适当大的尺寸。
可将肛门镜20设置为外科器械组件的一部分,因此也可包括图2所示的痔治疗装置48。装置48包括器械轴50、在轴的近端连接到轴的把手或作动器52、以及在轴的远端安装于轴上的一对钳夹54和56(近端和远端)。把手52可操作地被连接到钳夹54和56,以便可选择地张开和闭拢钳夹。每个钳夹54和56均采用C或U型夹紧件的形状,以可供选择的方式远离另一钳夹和朝另一钳夹运动。
钳夹54和56限定出对应缝隙55和57。器械轴50的远端部分的横截面呈U或C型形状,并限定出与缝隙55对准并连通的凹陷部分59。器械轴50的远端的这种非对称的形状在痔治疗装置48的远端部分插入肛门镜20中时有利于目视观察外科部位。
在钳夹54和56上安装有痔闭塞部件以对夹紧于钳夹之间的组织产生作用从而使组织相互结合。痔闭塞部件可采用任何能使器官组织、特别是痔组织相互联结的形式。如图3所示,痔闭塞部件可采用吻合器机构58的形式,该机构包括多个设置在弓形地配置于近侧钳夹54内的吻合器60。吻合器60沿纵向在远侧上与在钳夹54上的各喷射孔62对准,而在近侧上与各推动器元件64对准。可将推动器元件64设置在近侧上并与在近端上可操作地与把手52连接的压力应用环(未示出)或其他力传递结构接触。远侧钳夹56具有一系列与各槽或喷射孔62对准的砧元件或区域(未示出),以用于在发射(firing)时使吻合器闭合。
可将吻合器60装在一次性盒元件内,该盒元件可以是近侧钳夹54的一部分或全部。这种变型允许外科医生、直肠病学家或其他医护人员在单一治疗步骤进程(in the course of a single procedure)中夹紧多个痔。在吻合一痔后,如在下面参考图7A-7F所讨论的那样,去除排空的盒(例如,钳夹54)并用类似的载有吻合器的盒替代。
如图4所示,一种可供选择的痔闭塞部件采用注射机构66的形式,该注射机构包括多个固定于近侧钳夹54上的中空针头68。针头68沿纵向定向并围绕钳夹54圆周隔开。针头68可通过分配支管70被连接到盛有如浓糖溶液或生物相容性黏合剂之类的硬化剂的贮存器72上。
图5示出了另一可供选择的以辐射能发生器74形式的闭塞部件,例如,电磁波谱的红外或光学部分。更具体地说,辐射能发生器74包括通过分配支管78连接到激光辐射源80的光纤76。
图6示出了又一种可供选择的以电极82的形式的闭塞部件,该电极安装在近侧钳夹54处并沿远侧方向面向远侧钳夹56。在需要两极传递电能的情况下,远侧钳夹56也可装有电极(未示出)。可将电极82连接到射频(RF)电流源84,以向痔组织传送RF烧灼电流。
钳夹54和56与杆86和88一起可形成可从轴50取出的一次性的闭塞盒。在对一个患者进行痔治疗的过程完成后,可去除盒并用新盒代替以用于另一患者。
在使用注射机构66的情况下,辐射能发生器74、或电极82、把手52可设有口或连接器85,以便能将手持式痔治疗装置48分别联结到贮存器72、激光源80、或RF电源84。
此外,如图2所示,钳夹54和56被安装到一对在近端被连接到器械轴50的平行的杆86和88上。钳夹54和56通过杆86和88相互连接并连接到轴50上,使钳夹在钳夹的张开和闭拢过程中保持相互平行并垂直于杆86和88。任何现有技术中已知的或之后开发出的可互易的装置机构都可操作地结合到钳夹54和56以及把手52,以便能通过操作把手52而张开和闭拢钳夹54和56。
在图2所示的痔治疗装置48的此实施例中,远侧钳夹56可滑动地结合到杆86和88上,近侧钳夹54相对于这些杆固定,所述杆在其相对侧被结合到远侧钳夹56。可将钳夹54和56以及杆86和88制成可从器械轴50拆卸的一次性盒组件。或者,可将如吻合器60和孔62之类的操作部分构成为可与钳夹54和56分离的一次性盒的一些部分。
图7A-7F示出了使用肛门镜20和痔治疗装置48治疗痔的方法步骤。如图7A所示,通过透明的肛口件89将带有关闭窗口36的遮板件24的肛门镜20插入肛管AC并操纵肛门镜,使痔组织HT邻近窗口36。此治疗步骤可包括在肛管AC内侧纵向移动和/或转动肛门镜20,直到肛门镜相对于痔组织HT处于期望位置为止。为此,遮板件24以及中空体22的任意侧壁34可由透明的聚合材料构成。于是,在操纵肛门镜的过程中,可通过侧壁34和遮板件24目视观察肛门组织。
在完成肛门镜20的适当定位后,如图7B中的箭头92所示,遮板件24在外部凸缘或指状夹件90处被抓住并沿近端方向拉动。此动作未覆盖窗口36并能使痔组织HT通过窗口突出到肛门镜20的通道26内。随后,将痔治疗装置48的远端部分尤其包括钳夹54和56插入肛门镜20内。如图7C所示,这种插入可利用钳夹54和56来完成,这些钳夹位于通道26内,在与凸出的侧壁部分40(参看图7C和8)相对的纵轴线38的一侧上,借此,使突出的痔组织HT穿过由钳夹56限定的槽或缝隙94。在这种情况下,安置痔治疗装置48之后,如图7D和9所示,该装置围绕纵向轴线转动,且可被传递成与该轴线正交,使钳夹54和56对准带有突出的痔组织HT的颈部或基底区域96。
在一可供选择地采用的治疗步骤中,将痔治疗装置48的远端部分插入肛门镜20内的方式为使钳夹54和56定位在通道26内与凸出的侧壁部分40在纵轴线38的相同侧(图7C和8)。因为突出的痔组织HT是韧性的,痔治疗装置48的远端钳夹56可滑过突出的组织。在采用手术的插入(和取出)阶段,根据肛门镜20、痔治疗装置48、以及突出的痔组织HT的相关尺寸扭动痔治疗装置48可能是必需的或有利的。在这种可供选择的所采用的治疗步骤中,如图7D和9所示,不必围绕纵向轴线转动装置48而使钳夹54和56与突出的痔组织HT的颈部或基底区域96对准。
如图7E所示,将钳夹54和56定位在痔组织HT的相对侧时,其相互接近以夹紧痔组织HT。优选在使钳夹54和56闭拢和张开的过程中,使其保持相互平行。
如图7E所示,当钳夹54和56围绕组织HT的颈部区域96夹紧时,可操作痔治疗装置48的组织闭塞部件(图3-6),以便在颈部区域96内或围绕颈部区域永久地缢缩痔组织HT。在应用吻合器机构58(图3)的情况下,借助于推动器元件64的远侧运动通过钳夹54内的喷射孔62射出吻合器60,吻合器在碰到远侧钳夹56中的各砧元件(未示出)时闭合。在应用注射机构66(图4)的情况下,在钳夹54和56的接近过程中,固定到近侧钳夹54的中空针头68自然地或自动地插入痔组织内。然后将硬化剂从贮存器72导引到痔组织HT内。在使用辐射能发生器74(图5)的情况下,操作发生器以产生预定光谱范围的电磁辐射,其然后通过光纤76被导引到痔组织HT内。在使用图6的射频烧灼组件的情况下,从源84通过电极82将射频流传导到痔组织HT内。在远侧钳夹56也设有电极之处,电流从电极82通过颈部或基底区域96流到钳夹56。在使用单极烧灼电流时,电流从组织HT流出分散到患者体内。
在闭塞操作完成后,操作把手52以使钳夹54和56相互分开,并操纵治疗装置48以将钳夹与被治疗的痔组织HT(图7F)分离。然后进一步操纵治疗装置48,以从肛门镜20中抽出。此外,由于被夹紧的痔组织HT的变形,在很多情况下可简单地抽出痔治疗装置48而不用转动,但可能需要一些扭动。
可用手术刀横切远离被闭塞的颈部区域96的痔组织HT或使其局部缺血退化或自身截断。在闭塞治疗步骤的几天内可发生自身截断。局部缺血退化则在几周内发生。局部缺血退化和自身截断是由颈部或基底区域96内的血管的闭塞引起的。
肛门镜20的凸出部分或突起40起肛门(collateral anal)侧支或直肠组织的牵开器的作用。另外,凸出部分或突起40在痔组织HT的区域内形成更多的工作空间。这种设计可更好地进入位于靠近直肠肌肉的黏膜下层的层的组织HT的颈部或基底96。
图8-10示出了凸出部分或突起40的一种结构,其中突出的曲率半径大于中空体22的其余部分的曲率半径。其他结构也是可能的。图11示出了凸出部分或突起98的曲率半径小于中空体件22的主要部分的曲率半径的结构。图12示出了凸出部分或突起100的曲率半径基本等于中空体件22的曲率半径的结构。虚线102、104、106表示痔治疗装置48的相应闭塞钳夹。
通常,将肛门镜20插入肛管之后施行将肛门镜20与带有痔组织的窗口36对准的操作。肛门镜20和端口件89优选由能有利于目视观察和痔定位的透明聚合材料构成。将肛门镜20插入肛管AC之后、在操纵肛门镜20与带有痔组织HT的窗口对准之后、及在使痔组织HT通过窗口36突出之后,将闭塞装置的钳夹54和56插入肛门镜20内。
在这里公开的痔治疗器械或装置可以部分为一次性使用或完全为一次性使用。当钳夹54和56两者都是可移动地连接到轴50的一次性盒的一些部分时,器械的近侧部分也可用于在不同的时间治疗不同的病人。可供选择地或另外地,在近侧钳夹54包括吻合器储料匣处可更换钳夹54,以便能在同一患者上实施多次痔闭塞治疗步骤。
图13-18示出了手术器械组件,更具体地说示出了用于痔治疗的组织闭塞肛门镜组件120。器械组件120包括中空件122,该中空件具有设有窗口126的侧壁124,而且该器械组件还包括可滑动地连接到中空件以用于选择性地覆盖和不覆盖窗口的关闭件128。中空件122具有沿窗口126的棱边的第一夹紧表面130。关闭件128具有第二夹紧表面132,该第二夹紧表面与夹紧表面130相对且在图13-15和18中示出的器械的夹紧或闭合结构中基本与所述第一夹紧表面相邻配置。关闭件128可沿近侧方向滑动离开夹紧表面130,以开启窗口126,如图16和17所示。
组织闭塞器械组件120另外还包括组织闭塞部件134,该组织闭塞部件安装在中空件122和关闭件128中的至少之一,用于作用在夹紧表面130和132之间紧夹的器官组织上,以使组织相互结合。组织闭塞部件134可以是吻合器机构、可连接到硬化剂贮存器的注射机构、或可连接到激光辐射源的光学纤维。
中空件122的侧壁124通常呈圆锥状地弯曲,使夹紧表面130和132为弯曲形状,例如,C型或U型。夹紧表面130和132处于垂直于器械120的纵向轴线136延伸的平行平面上且在关闭件128的开启和关闭过程中保持相互平行。关闭件128平行轴线136运动。
中空件122在远端138封闭并限定出纵向通道140,在该通道中部分地设有关闭件128。窗口126与通道140相通。在与封闭端138相对的近端,中空体122设有包括纵向延伸的棒144(即,定向在相对于轴线136较小角度处)的把手142以及基本上横向延伸的握柄146。关闭件128包括形成为通道件的主要部分148,在与夹紧表面132相对的主要部分148的端部处,握柄150平行于把手142的握柄146延伸。把手142的棒部分144形成为可滑动地接收关闭件或遮板件128的主要部分148的通道件。
图19-22示出了组织闭塞器械组件152的内窥镜转位(endoscopicversion),该组件包括具有用于接收内窥镜的插入件158的通道156的中空体件154。中空件154并入相对于通道156横向定位的室160。室160由分隔件或壁162任意地与通道156分开。内窥镜插入件158围绕室160以弧形方式延伸,据此其位于中空体件154的凸出部分164内。
中空体件154、尤其是其凸出壁164具有窗口或孔166,通过该窗口或孔例如息肉168之类的器官组织可在内窥镜组织闭塞治疗步骤中突出。在这种治疗步骤中,如图所示,带有联接到其上的中空体件154的内窥镜插入件158通过如肛门孔之类的天然体口端插入内腔,例如,插入结肠。在内窥镜插入件158的远端面170上的光学部件(未示出)被用来目视观察体腔壁并被用来检测包含息肉168或其他不希望的组织块的外科部位。
组织闭塞器械组件152还包括在远端包括了组织夹紧表面174的关闭件或遮板件172。表面174通常具有弓形形状并置于横向于器械组件的纵向轴线176的平面上。表面174可与另一弓形组织夹紧表面178相对,该弓形组织夹紧表面沿窗口166的远端棱边(未具体标出)联接到中空体件154。表面178同样也置于横向于纵向轴线176的平面内,并因此平行于表面174。
关闭件或遮板172被联接到可滑动地设置在平行于轴线176延伸的中空体件154的通道182内的杆180的远端。在实施手术的最初阶段,沿远侧方向推杆180,使关闭件或遮板172覆盖或关闭开口166。当达到预期的外科部位时,沿近侧方向拉出杆180以从窗口166去除关闭件或遮板172,并使息肉168通过窗口166突出到室160内。
体件154设于带有开口184的室160中,通过该开口可实现对室160的目视观察。开口184可通过内窥镜插入件158的光学部件(示例性地包括照明光源、透镜,及光纤束-未示出)提供对室160的视觉检查口(visualaccess)。或者,如在下面将参考图23和24所讨论的那样,中空体件154可设有其自身使用的光学部件以建立通向室160的视觉检查口。
中空体件154沿室160可另外设置开口186,以便能通过如吸入装置188之类的内窥镜器械的工作顶端进入(sccess)室160。吸入装置188包括与息肉168嵌合的圆锥形头190。在施行吸入操作时,沿近侧方向通过内窥镜插入件的工作通道192或中空体件154拉动装置188。于是,息肉168伸出以便于闭塞操作,而在闭塞操作中关闭件或遮板件172沿远侧方向运动,使息肉168的茎或颈部组织194被夹在夹紧表面174和178之间。然后,闭塞部件196操作通过夹紧表面178和/或表面176以实现茎或颈部组织194的闭塞。作为示例,闭塞部件196可采用吻合器机构、可连接到硬化剂贮存器的注射机构、或可连接到激光辐射源的光纤的形式。在这里公开的组织闭塞器械组件的任一实施例中,组织闭塞部件可通过元件或电流传输部件产生的电阻热来实现组织的加热。
与此处的其他治疗步骤中所预期的那样,在参考图19-22的上述讨论过程的终结时,在施加闭塞能量后可开启关闭件或遮板件172。然后,使如息肉168之类的已闭塞的组织块滑出室160回到天然体的内腔内。
图23和24示出了与图19-22所示的器械组件152类似的组织闭塞器械组件202。在组件202中,具有接收内窥镜插入件208的通道206的中空体件204结合有光纤照明导引部分210、光纤图象导引部分214、至少一个用于使用内窥镜器械的工作通道216、用于在弯曲的内窥镜插入件208内有利于形成与通道206相邻的室222的缆线218和220。通过中空体件204的通道226插入硬挺杆224还有利于室222的形成。
因此,可将中空体件204形成为内窥镜护套的形式,该内窥镜护套的远端可变形,以使室222从摺叠插入结构膨胀到如图24中具体示出的膨胀后的使用结构。照明导引部分210和图象导引部分214远侧终止于沿室222的壁的光进入开口212和228处。
第一弓形夹紧表面230沿与室222相通的窗口232的远侧棱边被定位在中空体件204上。第二弓形夹紧表面234被联接到关闭件或遮板件236的远端上。关闭件或遮板件236被联接到杆238上,该杆在插入操作中可选择地沿远侧和近侧方向移动关闭件以实现窗口232的关闭,窗口232的开启能使组织块突出到室222内,而在向组织施加能量的过程中夹紧突出组织以使其闭塞。在表面234处设置在关闭件236上的组织闭塞部件240可采用上述器械的任何形式。
通过工作通道216插入的吸入装置244的吸入头242可用于将息肉246抽离体内腔的壁248以有利于组织闭塞操作。
组织闭塞器械组件152和202可用于治疗多种病症(息肉、壁穿孔、在先前设置的吻合器线处的出血点等),但其一般不用于治疗痔。内镜组织闭塞器械组件152和202可被用于治疗除结肠外的天然和人造内腔的损伤,这些内腔包括气管、支气管、血管(动脉和静脉)等。
其他已知的外科操作/手术的类型可通过使用组织闭塞器械组件152和202来实现,例如对在血管内的内膜/内皮损伤(动脉斑块,等)施行手术或在病变的静脉或动脉瓣膜上施行手术。为了实施这种附加的治疗步骤,可使广泛的内窥镜外科器械{剪、抓紧器、剥离器、缝合夹钳(clip applier)等}通过内窥镜护套通道192、216介入目标组织。
当需从患者体内切断器官组织然后摘除时,摘除操作可以或者通过工作通道192、216实现,或者在抽出整个器械的过程中实施。在后者的情况下,在带到患者外侧之前,将切断的标本带进室160、222内。
当外科手术导致血管出血时,可通过射频或注射硬化剂或止血剂使血管凝结。
此处所描述的任何检查和外科操作法也可与外部操作法结合实施,例如,与腹腔镜操作法结合实施。这种腹腔内镜方法通常在外科领域是公知的且可在保持微创方法的优点的同时有利于手术的执行和安全性。
需注意的是,可将杆86和88固定到远侧钳夹56并可滑动地与轴50连接。或者,可将杆86和88固定到远侧钳夹56和轴50两者上,在这种情况下近侧钳夹54可供选择地沿杆86和88滑向钳夹56和从其滑开。也可设置多于两个的杆86和88,以便用于将远侧钳夹56接合到器械轴50上。
在再一可供选择的设计中,在夹紧或闭拢过程中,钳夹54和56两者可沿杆86和88运动。这种设计可促进痔闭塞而不撕裂已闭塞的组织基底下方的组织。若只有一个钳夹54或56可沿杆86和88运动,那么在钳夹的闭拢过程中,整个器械可相对于患者运动,以确保预防不期望的组织撕裂。当远侧钳夹56可沿杆86和88滑动时,在远侧钳夹沿近侧方向运动的同时整个器械被推入患者体内。

Claims (29)

1.一种外科器械,包括:
具有侧壁的中空件,该侧壁上设有窗口;
可运动地连接到所述中空件的关闭件,用于可供选择地覆盖和不覆盖所述窗口,所述中空件具有沿所述窗口的棱边的第一夹紧表面,所述关闭件具有与所述第一夹紧表面相对且基本与其相邻配置的第二夹紧表面;及
组织闭塞组件,其被安装在所述中空件和所述关闭件的至少之一上,用于作用在所述第一夹紧表面和所述第二夹紧表面之间被紧夹的组织上,以使所述组织相互结合。
2.如权利要求1所述的器械,其中,所述中空件具有用于接收内窥镜的插入件的通道,所述中空件包括相对于所述通道横向定位的室,所述窗口与该室相通。
3.如权利要求2所述的器械,其中,所述关闭件可滑动地插入所述中空件内的通道内。
4.如权利要求2所述的器械,其中,所述中空件包括多个光进入口,以允许从所述中空件外侧目视观察所述室。
5.如权利要求2所述的器械,其中,所述中空件包括用于将内窥镜器械的远端导入所述室内的工作通道。
6.如权利要求1所述的器械,其中,所述侧壁是弯曲的,所述第一夹紧表面和第二夹紧表面的至少之一具有弯曲形状。
7.如权利要求1所述的器械,其中,所述关闭件可滑动地连接到所述中空件,在所述关闭件开启和关闭过程中,所述第一夹紧表面和所述第二夹紧表面基本保持相互平行。
8.如权利要求7所述的器械,其中,所述中空件设有通道,所述关闭件被部分地设置在所述通道内,所述窗口与所述通道相通。
9.如权利要求7所述的器械,其中,所述中空件具有纵向轴线,所述第一夹紧表面和所述第二夹紧表面在取向为基本垂直于所述轴线的平面内延伸,所述关闭件平行于所述轴线运动。
10.如权利要求1所述的器械,其中,还包括组织切断件,该切断件可操作地连接到所述中空件和所述关闭件之一上,用于切断远离由所述组织闭塞件至少部分地形成的闭塞部分的组织块。
11.一种外科器械,包括:
限定出纵向通道的中空体,所述中空体在近端至少部分敞开,所述中空体具有侧壁,该侧壁设有与所述近端隔开的窗口;及
遮板或关闭件,其可运动地安装在所述中空体上,以便在所述中空体定位于体腔内的过程中覆盖所述窗口,所述遮板或关闭件被从所述窗口移开,以使器官组织通过该窗口突出,
所述中空体具有形成有凸出部分的侧壁,所述窗口被定位在所述凸出部分内。
12.如权利要求11所述的外科器械,其中,所述中空体具有设置在所述凸出部分内的室,所述窗口与所述室连通,所述中空件具有将所述通道与所述室分隔开的分隔部分。
13.如权利要求11所述的外科器械,其中,所述通道的尺寸被确定为用于接收内窥镜的插入件。
14.一种外科方法,包括:
提供器械组件,该器械组件包括具有侧壁的中空体件,侧壁形成有窗口,该器械组件还包括组织闭塞部件,所述闭塞部件限定出一对钳夹,所述钳夹的至少之一包括弓形夹紧表面;
将所述中空体件插入患者的体腔内;
操纵所述中空体件使器官组织通过所述窗口突出到所述中空体件内;
在所述组织通过所述窗口突出后,操纵所述闭塞部件使所述钳夹定位在所述突出组织的相对侧;
然后闭拢所述钳夹以夹紧所述突出组织;及
随后操作所述闭塞部件,以永久地缢缩所述突出组织的一部分。
15.如权利要求14所述的方法,其中,所述闭塞部件包括组织切断装置,所述方法还包括操作所述组织切断装置,以切断远离由所述组织闭塞部件至少部分地形成的闭塞部分的组织块。
16.一种外科方法,包括:
提供内窥镜器械组件,该器械组件包括中空体件,该中空体件具有通道和形成带窗口的室的侧壁,内窥镜插入件被部分地设置在所述通道内;
将所述内窥镜插入件与所述中空体件一同插入患者的体腔内;
操纵所述内窥镜插入件和所述中空体件,使器官组织通过所述窗口突出到所述室内,所述室被横向设置或设置在与所述内窥镜插入件的侧壁相邻的位置;及
在所述组织通过所述窗口突出后,操纵至少一个延伸到所述室内的器械,以在所述突出组织上施行外科手术。
17.一种用于治疗痔的外科器械组件,包括肛门镜和痔闭塞装置,
所述肛门镜包括限定出纵向通道的中空体,该中空体在远端封闭而在近端至少部分敞开,该中空体具有侧壁,该侧壁设有与至少所述远端间隔开的窗口,
所述痔闭塞装置包括器械轴,在该轴的远端设有两个钳夹,所述钳夹的至少之一包括夹紧件,该夹紧件可选择地离开或朝向所述钳夹中的另一个运动,用来夹紧和闭塞通过所述窗口突出到所述肛门镜内的痔组织,所述钳夹被插入所述肛门镜内使所述钳夹被定位在通过所述窗口突出到所述肛门镜内的痔组织的相对侧,所述钳夹被安装到一对平行的杆上,每根杆的一端被连接到所述轴上。
18.如权利要求17所述的外科器械组件,其中,所述钳夹在被取向成基本垂直于所述杆的平面内延伸。
19.如权利要求17所述的外科器械组件,其中,所述钳夹中给定的一个可滑动地结合到所述杆上,而另一个所述钳夹相对于所述杆固定。
20.如权利要求17所述的外科器械组件,其中,所述痔闭塞装置还包括痔闭塞部件,该痔闭塞部件被安装在所述钳夹上,用于作用在紧夹于所述钳夹之间的组织上,以使所述组织相互结合。
21.如权利要求17所述的外科器械组件,其中,所述肛门镜还包括安装在所述中空体上、用来在将肛门镜定位于肛管内的过程中覆盖所述窗口的遮板件,该遮板件可相对于所述中空体运动,以便不覆盖所述窗口而使痔组织通过所述窗口突出到所述通道内。
22.如权利要求17所述的外科器械组件,其中,所述中空体具有纵向轴线,所述侧壁形成有位于所述轴线的一侧并从所述近端部分地沿所述侧壁的长度朝所述远端延伸的凸出部分,所述窗口位于所述凸出部分内。
23.如权利要求17所述的外科器械组件,其中,所述钳夹被安装在所述轴上,使得在所述钳夹的张开和闭拢的过程中保持相互平行。
24.如权利要求17所述的外科器械组件,其中,还包括切断件,其可操作地连接到所述闭塞装置上,用于切断远离由所述组织闭塞件至少部分地形成的闭塞部分的组织块。
25.如权利要求17所述的外科器械组件,其中,所述痔闭塞装置从由吻合器机构、可连接到硬化剂贮存器的注射机构、以及可连接到电磁辐射源的辐射导引元件组成的组中选取。
26.一种用于治疗痔的外科器械组件,包括肛门镜、关闭件、和痔闭塞装置,
所述肛门镜包括中空体,该中空体具有纵向轴线并限定出纵向通道,该中空体的远端封闭而近端至少部分地敞开,该中空体具有侧壁,该侧壁形成有位于所述轴线一侧并从所述近端部分地沿所述侧壁的长度向所述远端延伸的凸出部分,所述凸出部分带有与至少所述远端间隔开的窗口,
所述关闭件在所述凸出部分内可滑动地连接到所述中空体,以便可选择地覆盖和不覆盖所述窗口,
所述痔闭塞装置包括在远端装有两个钳夹的器械轴,所述钳夹的至少之一包括可选择地远离或朝向所述钳夹中的另一个运动、用来夹紧和闭塞通过所述窗口突出到所述肛门镜内的痔组织的夹紧件,所述钳夹被插入到所述肛门镜内,使所述钳夹定位在通过所述窗口突出到所述肛门镜内的痔组织的相对侧上。
27.如权利要求26所述的外科器械组件,其中,所述痔闭塞装置还包括痔闭塞部件,该痔闭塞部件被安装在所述钳夹上,用于作用在紧夹于所述钳夹之间的组织上,以使所述组织相互结合。
28.如权利要求27所述的外科器械组件,其中,所述痔闭塞部件从由吻合器机构、可连接到硬化剂贮存器的注射机构、及可连接到电磁辐射源的辐射导引元件组成的组中选取。
29.一种用于治疗痔的外科器械组件,包括肛门镜和痔闭塞装置,
所述肛门镜包括限定出纵向通道的中空体,该中空体的远端封闭而近端至少部分地敞开,该中空体具有侧壁,该侧壁带有至少与所述远端间隔开的窗口,
所述痔闭塞装置包括在远端设有两个钳夹的器械轴,所述钳夹的至少之一包括夹紧件,该夹紧件可选择地远离或朝向所述钳夹中的另一个运动,以夹紧和闭塞通过所述窗口突出到所述肛门镜内的痔组织,所述钳夹被插入所述肛门镜内使所述钳夹定位在通过所述窗口突出到所述肛门镜内的痔组织的相对侧上,
其中,所述钳夹被插入所述肛门镜内,使所述钳夹之一被定位在通过所述窗口突出到所述肛门镜内的痔组织的远处或远侧,在突出的痔组织和所述肛门镜的内侧或远端之间,使另一个所述钳夹定位在靠近所述突出的痔组织或突出的痔组织的近侧,在突出的痔组织和所述肛门镜的外部或近端之间。
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