CN102724923B - 具有可沿径向打开的远端部分的圆形缝合器引导器 - Google Patents
具有可沿径向打开的远端部分的圆形缝合器引导器 Download PDFInfo
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Abstract
本发明公开了用于将外科圆形缝合器引导到患者体内的引导器。多个实施例包括中空柔性护套(110),该中空柔性护套(110)具有远端(114)和开放近端(112),该开放近端(112)的尺寸形成为在其中接纳圆形缝合器的缝合头部部分。可沿径向打开的圆筒构件(152)附接到中空柔性护套的远端,以限定开口,该开口用于在其中接纳缝合头部。刚性端帽构件(160)可铰接地附接到可沿径向打开的圆筒构件并且能够在闭合位置和打开位置之间运动,在闭合位置中,刚性端帽构件覆盖圆筒构件中的开口的远端,在打开位置中,刚性端帽构件能够运动到暴露开口的远端的位置。可释放的闩锁构件(140)设置成接合和释放可沿径向打开的圆筒构件的相对的端部。
Description
技术领域
本发明整体涉及外科缝合器,并且更具体地,本发明涉及用于将圆形缝合装置引入到患者的结肠内的装置和方法。
背景技术
在某些类型的外科手术中,使用外科缝钉已成为连接组织的优选方法,并且因此已开发了用于这类用途的具有特殊构造的外科缝合器。例如,已经开发出腔内或圆形缝合器用于涉及低位结肠的外科手术,其中在病变部分已经切除之后将低位结肠的各部分连接在一起。用于施行这种手术的圆形缝合器在(例如)美国专利No.5,104,025;No.5,205,459;No.5,285,945;和No.5,309,927中有所公开,这些专利各自的全文均以引用的方式并入本文。
通常,常规圆形缝合器通常由具有近端致动机构的细长轴和安装在该细长轴上的远端缝合机构组成。远端缝合机构通常包括固定的钉仓,钉仓内含有构造成同心圆阵列的多个缝钉。圆形切刀同心安装在钉仓内缝钉以里的位置处以便在其中轴向运动。从钉仓中心轴向延伸的是活动的套管针轴,该套管针轴适于缝钉砧座可拆卸地连接到其上。当把缝钉驱入其中时砧座能使缝钉的末端成形。钉仓远端表面与缝钉砧座之间的距离常常由调节机构控制,调节机构安装在缝合器轴近端,用来控制套管针的轴向运动。当外科医生启动致动机构时,对夹在钉仓和缝钉砧座之间的组织同时进行缝合和切割。
使用圆形缝合器执行低位结肠手术时,通常采用常规的外科手术缝合器缝合肠,这种缝合器在待移除肠的患病部分任一侧安置两排缝钉。在缝合相邻末端的同时切除目标段。移除患病部分后,外科医生通常将砧座插入腔管近端,即缝合线近端。这可通过将砧座头部插入外科医生在近腔管切开的入口来完成。有时,可经肛门放置砧座,即通过将砧座头部放在缝合器的远端并通过直肠插入器械。然后外科医生可用缝线或其他常规的系结装置将肠的近端系在砧座轴上。接着,外科医生切除系结处附近多余的组织,并且外科医生将砧座附接到缝合器的套管针轴上。然后外科医生合拢砧座和钉仓之间的间隙,从而将肠的近端和远端夹紧在间隙中。外科医生随后启动缝合器,驱动若干排缝钉穿过肠的两端并使其成形,从而连接末端并形成管状通道。同时,在驱动并成形缝钉时,可驱动同心的圆形刀片穿过肠组织末端,从而切割邻近内排缝钉的末端。接着,外科医生从肠中取出缝合器,并完成手术。
在这种低位结肠手术期间,可能难以将外科缝合器插入穿过肛门且通过直肠壁中突出到结肠中的横向褶皱(通常称为“直肠瓣(Valves ofHouston)”)并且随后操作到期望的区域。当必须在砧座没有就位的情况下插入缝合器时,加剧了这个问题。具体地,大多数圆形缝合器的前端或远端包括被设计成支承圆形钉仓的相对较尖锐的圆形构件。这种钝的/尖锐的形状使得难以使缝合器的前端前进穿过直肠瓣和其他组织。
从而,需要用于容易地穿过患者的肛门将外科缝合器插入到患者体内的低位结肠或其他区域中的装置和方法。
上述讨论仅仅为了举例说明技术领域内目前存在的一些不足,而不应看作是对权利要求范围的否定。
发明内容
结合本发明的一般方面,提供一种用于将外科圆形缝合器引导到患者体内的引导器,该外科圆形缝合器具有柄部、从柄部突出的细长轴以及与细长轴联接的缝合头部。结合多个实施例,引导器包括中空柔性护套,该中空柔性护套具有远端和开放近端。中空柔性护套的尺寸可以形成为在其中接纳细长轴的至少一部分和缝合头部。可沿径向打开的圆筒构件可以附接到中空柔性护套的远端。圆筒构件可以限定开口,该开口用于在其中接纳缝合头部。刚性端帽构件可以可铰接地附接到可沿径向打开的圆筒构件并且能够在闭合位置和打开位置之间运动,在闭合位置中,刚性端帽构件覆盖圆筒构件中的开口的远端,在打开位置中,刚性端帽构件能够运动到暴露开口的远端的位置。闩锁构件可以取向成与圆筒构件的相对端部选择性地接合以将刚性端帽构件保持在闭合位置中,在解锁位置中,相对的端部可以沿径向彼此远离地运动,以使得刚性端帽构件能够运动到打开位置。
结合本发明的另一个一般方面,提供一种用于将外科圆形缝合器引导到患者体内的引导器,该外科圆形缝合器具有柄部、从柄部突出的细长轴以及与细长轴联接的缝合头部。结合多个实施例,引导器包括中空柔性护套,该中空柔性护套具有远端和开放近端。中空柔性护套的尺寸可以形成为在其中接纳细长轴的至少一部分和缝合头部。可沿径向打开的圆筒构件可以附接到中空柔性护套的远端。圆筒构件可以限定开口,该开口用于当圆筒构件处于闩锁位置时在其中接纳缝合头部。刚性端帽构件可以可铰接地附接到圆筒构件。刚性端帽构件能够在闭合位置和打开位置之间运动,在该闭合位置中,刚性端帽构件保持在闭合位置中,以便在缝合头部已经插入到该刚性端帽构件中至完全插入位置时覆盖缝合头部的远侧面,该打开位置暴露缝合头部的远侧面。闩锁构件可以设置成将圆筒构件的相对端部可释放地保持在闩锁位置中。在向闩锁构件实施释放运动时,闩锁构件可以将圆筒构件的相对端部彼此远离地推压到解锁位置。
结合本发明的另一个一般方面,提供一种用于将外科圆形缝合器的缝合头部和细长轴引导到患者体内的方法。该方法可以包括将缝合头部和细长轴插入到引导器中,该引导器包括中空护套,该中空护套上附接有刚性远侧端帽组件。该方法还可以包括将缝合头部和细长轴部分以及中空护套插入到患者体内,使得引导器的一部分能够从患者体外触及并且将缝合头部定位在患者体内的期望位置中。该方法还可以包括将引导器从患者退回而不将缝合头部从患者退回到体外。
附图说明
并入本文中并且构成本说明书一部分的附图示出了本发明的实施例,并且与上面所给出的概述和下面所给出的具体实施方式一起用于解释本发明的原理。
图1为外科圆形缝合器械的透视图;
图2其上安装本发明实施例的引导器之前的图1的圆形外科缝合器械的另一个透视图;
图3为本发明实施例的引导器的侧正视图;
图4为图2的引导器的俯视图;
图5为图3和4的引导器的俯视图;
图6为图2-5的引导器的另一个俯视图,其中覆盖面板从柄部组件移除;
图7为安装在圆形缝合器械上的本发明实施例的引导器的局部透视图;
图8为图7的引导器和圆形缝合器的局部侧正视图;
图9为图7和8的引导器和圆形缝合器的局部俯视图;
图10为本发明实施例的端帽组件的正视图;
图11为图10的端帽组件的另一个正视图,其中释放闩锁从该端帽组件移除;
图12为图8-11的端帽组件的透视图,其中释放闩锁从该端帽组件移除并且端帽与圆筒组件脱开;
图13为本发明实施例的端帽组件的横截面图,其中端帽与圆筒组件接合;
图14为本发明实施例的圆形缝合器的一部分和引导器端帽的局部侧正视图;
图14A为圆形缝合器和端帽的另一个局部侧正视图,其中端帽从圆形缝合器的缝合头部部分的周边滑落;
图15为本发明实施例的端帽组件的俯视图,其中端帽处于打开位置;
图16为图15实施例的端帽组件的另一个俯视图,其中线条示出了薄型端帽实施例;
图18为本发明实施例的端帽组件的顶部透视图;
图19为图18的端帽组件的仰视图;
图20为本发明实施例的另一个端帽组件的顶部透视图;
图21为图20的端帽组件的仰视图;
图22为其上安装本发明实施例的另一个引导器之前的圆形外科缝合器械的透视图;
图23为其上安装本发明实施例的另一个引导器之前的圆形外科缝合器械的透视图;
图24为示出了安装在圆形缝合器的缝合头部的一部分上之前的本发明实施例的另一个引导器的分解正视图;
图25为安装在圆形缝合器的缝合头部上的图24的引导器的横截面图;
图26为本发明实施例的引导器的远端视图;
图27为本发明实施例的另一个引导器的远端视图;
图28为本发明实施例的另一个引导器的远端视图;
图29为安装在圆形缝合器的缝合头部上的本发明实施例的另一个引导器的横截面图;
图30为处于闭合位置的本发明实施例的另一个引导器的侧正视图;
图31为图31的引导器的另一个侧正视图;
图32为处于闭合位置的图30和31的引导器的另一个侧正视图;
图33为附接到圆形缝合器的缝合头部的本发明实施例的另一个引导器的远端视图;
图34为附接到圆形缝合器的缝合头部的本发明实施例的另一个引导器的侧正视图,其中圆形缝合器的套管针部分处于延伸位置;
图35为附接到圆形缝合器的缝合头部的本发明实施例的另一个引导器的远端视图;
图36为附接到圆形缝合器的缝合头部的本发明实施例的另一个引导器的侧正视图,其中圆形缝合器的套管针部分处于延伸位置;
图37为图36的引导器和缝合头部的另一个侧正视图,其中圆形缝合器的套管针部分处于退回位置;
图38为附接到圆形缝合器的缝合头部的本发明实施例的另一个引导器的侧正视图;
图39为附接到圆形缝合器的缝合头部的本发明实施例的另一个引导器的局部透视图;
图40为从圆形缝合器的缝合头部退绕的图39的实施例的引导器的另一个局部透视图;
图41为附接到圆形缝合器的缝合头部的本发明实施例的另一个引导器的局部透视图;
图42为附接到圆形缝合器的缝合头部的本发明实施例的另一个引导器的局部透视图;
图43为从圆形缝合器的缝合头部向近侧退回的图42的引导器的另一个局部透视图;
图44为附接到圆形缝合器的缝合头部的本发明实施例的另一个引导器的局部透视图;
图45为图44实施例的引导器的另一个局部透视图,其中已经向该引导器实施初始释放运动;以及
图46为图44和45的引导器的另一个局部透视图,示出了向该引导器进一步实施释放运动。
具体实施方式
本申请的申请人还拥有以下的美国专利申请,这些专利申请与本申请同一天提交,并且每个都以引用的方式各自整体并入本文:
系列号为No.________,名称为“DEVICES AND METHODS FORINTRODUCING A SURGICAL CIRCULAR STAPLING INSTRUMENT INTOA PATIENT(用于将外科圆形缝合器械引导到患者体内的装置和方法)”的美国专利申请,代理人案卷号END6320USNP/090234;
系列号为No.________,名称为“CIRCULAR STAPLER INTRODUCERWITH RIGID CAP ASSEMBLY CONFIGURED FOR EASY REMOVAL(具有构造为用于便于拆卸的刚性端帽组件的圆形缝合器引导器)”的美国专利申请,代理人案卷号END6615USNP/090245;
系列号为No.________,名称为“CIRCULAR STAPLER INTRODUCERWITH RIGID DISTAL END PORTION(具有刚性远端部分的圆形缝合器引导器)”的美国专利申请,代理人案卷号END6617USNP/090247;以及
系列号为No.________,名称为“CIRCULAR STAPLER INTRODUCERWITH MULTI-LUMEN SHEATH(具有多腔护套的圆形缝合器引导器)”的美国专利申请,代理人案卷号END6618USNP/090233。
现在将描述某些示例性实施例以从整体上理解本发明所公开的装置的结构、功能、制造和使用的原理以及本发明所公开的方法的原理。这些实施例的一个或多个实例在附图中示出。本领域的普通技术人员将会理解,本文特别描述和在附图中示出的器械和方法为非限制性的示例性实施例,并且本发明多个实施例的范围仅由权利要求书限定。就一个示例性实施例进行图解说明或描述的特征,可与其他实施例的特征进行组合。这种修改形式和变化形式旨在包括在本发明的范围之内。
本文所用术语“近侧”和“远侧”是相对于操纵外科手术器械手柄的临床医生而言的。术语“近侧”是指最靠近临床医生的部分,术语“远侧”则是指远离临床医生的部分。还应当理解,为简洁和清楚起见,本文可以结合附图使用诸如“竖直”、“水平”、“上”和“下”之类的空间术语。然而,外科器械能够在许多方向和位置使用,并且这些术语并非限制性和/或绝对化的。
图1示出了常规的圆形缝合器10。这种圆形缝合器的构造和操作在本领域中通常是已知的。从而,本文中将不会详细讨论超过理解本发明的多个实施例的构造和操作可能需要的这种圆形缝合器的特定部件和特征物。看了本“具体实施方式”之后,本领域的普通技术人员将会理解,在不脱离本发明的精神和范围的情况下,本发明的多种实施例可以有效地用于各种不同的圆形缝合器构造。因此,本发明的多个实施例的保护范围不应当限制成用于本文所示的示例性圆形缝合器。
从图1可以看到,常规的圆形缝合器10通常包括柄部12,该柄部12具有从其突出的细长轴14。缝合头部16联接到细长轴14的远端15并且能够可操作地支承钉仓17和其中的活动刀片组件(未示出)。圆形缝合器10还包括具有砧座本体22的砧座20。砧座20具有砧座轴24,该砧座轴24能够可移除地附接到套管针(未示出),该套管针可运动地支承在圆形缝合器10的细长轴14内。通过旋转调节旋钮18来实现套管针的运动,该调节旋钮18位于柄部12的近端处。指示器面板19可以设置在柄部12上,以便向使用者提供砧座20的本体部分22相对于钉仓17的位置的指示。从而,当砧座轴24附接到可运动套管针时,砧座本体22相对于钉仓17在缝合头部组件16中的位置可以通过旋转调节旋钮18进行调节。缝合头部16还支承缝钉驱动器组件(未示出),缝钉驱动器组件的操作由柄部12上的触发器组件26控制。涉及示例性圆形缝合器10的操作和组装的进一步的细节可以例如参考John P.Measamer的2009年3月23日提交的系列号为No.12/408,905、名称为“Circular Surgical Stapling Instrument With Anvil LockingSystem(具有砧座锁定系统的圆形外科缝合器械)”的美国专利申请而得到,该专利申请的公开内容全文以引用的方式并入本文。
图2-6示出了本发明的圆形缝合器引导器100,其可以与圆形缝合器10结合使用。在多个实施例中,引导器100包括细长中空柔性护套110,该细长中空柔性护套110可以由例如塑性材料制成,该塑性材料例如聚氨酯共混物、聚酯、聚乙烯或聚丙烯,厚度为0.004-0.015英寸并且形成第一内腔29,该第一内腔29的尺寸制定为易于插到圆形缝合器10的细长轴14上。护套110具有远端114和开放近端112以及一般指定为111的顶部和底部113。参见图3。柄部组件130可以通过例如粘合剂或超声焊接、射频(RF)焊接或热铆接附接到开放近端112。护套110的远端114可以通过粘合剂或通过超声焊接、射频(RF)焊接或热铆接附接到刚性端帽组件130。在多个实施例中,为例如打孔接缝116形式的“削弱区域”可以沿着护套110的底部113从开放近端112延伸到远端114。此外,第二内腔120可以形成在护套110的壁中并且从开放近端112延伸到远端114。具体地,第二内腔120可以从近端112的顶部111螺旋地延伸到远端114处的底部113。第二内腔120可以容纳释放构件122,该释放构件122从柄部组件130延伸到闩锁构件140,该闩锁构件140可运动地支承在第二内腔120的远端部分中。在多个实施例中,释放构件122可以包括例如缝合线。在其它实施例中,释放构件122可以包括相对较薄的柔性杆或类似构件,以用于将释放运动传递到附接到其上的闩锁构件140。第二内腔120可以通过例如缝合、超声焊接、射频(RF)焊接、热铆接等形成在护套110的壁中。释放构件122和闩锁构件140可以共同形成一般指定为121的释放装置。参见图10。
图10-19示出了刚性端帽组件150,其可以与本发明的多个实施例结合使用。刚性端帽组件150可以具有圆筒构件152,该圆筒构件152附接到护套110的远端114。圆筒构件152包括部分环状构件,该部分环状构件具有两个相对的端部154、156。刚性端帽构件160通过拴系件162“可铰接地附接”到圆筒构件152。参见图17。在多个实施例中,刚性端帽组件150被制成为具有显著不同物理特性的单个注射模制的部件。例如,在多个实施例中,刚性端帽组件150可以由聚氨酯共混物、聚酯、聚乙烯或聚丙烯注射模制而成。
如将在下面进一步详细讨论的,端帽构件160通过增加其横截面积而制成为刚性的,同时拴系件162和圆筒构件152优选地通过减小其相应横截面而设计成允许沿特定方向的显著挠曲。端帽构件160具有相对较钝的远侧面164,该远侧面164基本上是平滑的,以最小化将引导器100和圆形缝合器10的容纳在引导器100中的部分插入穿过患者的括约肌所需的力,以及有助于将该装置引导穿过直肠瓣和其他解剖组织。端帽构件160的下侧166可以具有形成在其中的一系列加强肋168,以增加其横截面积并且使得端帽构件160为大体刚性的。参照图13和图19。
在多个实施例中,端帽构件的下侧166具有的形状基本上与缝合头部16的周边的一部分的形状相匹配。更具体地且从图13可以看到,由加强肋168形成的下侧166的形状为弓形,该形状与圆形缝合器10的缝合头部16的圆形周边形状的一部分相匹配。从图14还可以看到,端帽构件160具有侧部170、172,每个侧部具有与弓形下侧166相对应的切口壁部分174。这种弓形下侧166和切口壁部分174使得端帽组件150能够在圆形缝合器10上方向近侧退回时向近侧顺利通过缝合头部16,从而当端帽组件150通过圆形缝合器10的缝合头部16时减小肠的径向膨胀。例如,图16提供了没有弓形下侧166的端帽组件150(用虚线180表示)与具有弓形下侧166的端帽组件150之间的示例性比较。如图所示,对于一个示例性实施例,没有弓形下侧的端帽组件具有0.22″更高的外形,因此将在其在缝合头部16上方向近侧退回时使肠进一步膨胀。
在多个实施例中,拴系件162可以设计成其长度比在闭合位置(图10)中将端帽构件160连接到圆筒构件152所需的距离更长。也就是说,当刚性端帽部分160保持在闭合位置中时,拴系件162可以在端帽组件150内部盘绕。这样的布置允许端帽构件160在越过缝合器10的缝合头部16的角部时跟随基本上弯曲的路径并且在移除期间与圆筒构件152独立地运动。参照图14和图14A。在一个实施例中,拴系件162沿直径方向与闩锁构件140接合圆筒构件152的相对端部154、156的位置相对。参照图18和图19。在可供选择的实施例中,拴系件162定位成与闩锁构件140成90度。参照图20和图21。
端帽组件150的多个实施例采用的特征物一起用来确保端帽构件160在插入过程期间不会打开,同时保持在合适的时间易于打开和移除的能力。例如,从图13可以看到,端帽组件150的多个实施例可以包括形成在圆筒构件152的各部分上的向内延伸的保持器凸缘190。保持器凸缘190可以定位成与在端帽构件160的下边沿上形成的对应的保持肋167固定地接合。从图13可以看到,一系列角撑板194可以形成具有保持器凸缘190,以进一步稳定和刚性化保持凸缘190。多个端帽构件实施例可以包括端帽构件160上的至少一个保持肋,以将端帽构件160保持性地固定在闭合位置中,在该闭合位置中,端帽构件160覆盖缝合头部16的远侧面25(图10)。在多个实施例中,一系列三个肋200、202、204可以形成在端帽构件160的位于拴系件162和弓形切口部分174之间的两个部分上。两个外肋200、202、204可以设置有斜切引出部分206。参见图12。这样的斜切引出部分206与圆筒构件152上的保持凸缘190交接,并且可以用来最小化端帽构件160在解锁过程期间粘合在保持凸缘190上的机会,而不会显著降低肋167和保持凸缘190布置在插入过程期间承载载荷的能力。
从图11和图12可以看到,圆筒构件152的相对端部154、156彼此间隔开,以限定用于在其中接纳闩锁构件140的闩锁区域210。闩锁构件140可以由塑性材料形成,并且具有本体部分141,该本体部分141上形成具有一对向远侧突出的闩锁突出部142、144。参见图11。闩锁突出部142、144的尺寸制定为延伸到闩锁腔体157、159中,该闩锁腔体157、159形成在杆152的相对端部154、156中。参见图10和图11。从而,当闩锁突出部142、144被接纳在闩锁腔体157、159中时,圆筒构件152形成能够沿径向打开的环状结构,该环状结构的尺寸制定为在其中容纳圆形缝合器10的缝合头部16。在多个实施例中,当圆筒构件152被闩锁在端帽构件160覆盖圆形缝合器10的缝合头部16的远侧面25的闭合位置中时,端帽构件160可以直接坐落在圆形缝合器10的缝合头部16的远侧面25上,而不会干涉其中支承的钉仓17中的任何缝钉凹部。这样的布置允许端帽构件160在插入过程期间受到的力被直接传递到圆形缝合器10的缝合头部16,而不需要任何力平衡或中间部件。
另外在多个实施例中,释放构件140可以进一步形成具有释放指状物145,该释放指状物145可以用来当闩锁构件140被沿近侧拉出而不与圆筒构件152的相对端部154、156接合时帮助沿径向打开圆筒构件152。更具体地且参照图11,闩锁构件140可以形成具有居中地设置在闩锁突出部142、144之间的释放指状物145。释放指状物145可以形成具有凸轮部分147,该凸轮部分147设计成与在圆筒构件152的相对端部154、156上形成的凸轮表面161、163接合,使得当闩锁构件140被沿近侧方向“P”拉动时,凸轮部分147接合凸轮表面161、163,以将圆筒构件152的相对端部154、156彼此沿径向推压分隔开(在图12中用箭头“R”表示)。从而,闩锁构件140沿着与将端帽构件160从圆筒构件152脱离所需的运动方向“R”基本上垂直的方向(近侧方向“P”)被拉动。当闩锁构件140被移除且临床医生继续向引导器100实施额外的收回运动时,允许圆筒构件152的相对端部154、156进一步沿径向间隔开并且使得端帽构件160能够从圆筒构件152脱离且运动到打开位置。这样,可以允许端帽构件160旋转到侧向打开位置,以有助于端帽组件150随着引导器100从患者向近侧被收回而在缝合头部16上方向近侧运动。参见图14。
从图7-9可以看到,柄部组件130可以设计成当缝合头部16在完全插入位置已经插入到闭合的端帽组件150中时与圆形缝合器10的柄部12的几何形状适形。例如,当刚性端帽构件160的下边沿部分与缝合头部16的远侧面25接触时,缝合头部16可以被认为是处于“完全插入”位置。更广义地,当远侧面25与刚性端帽构件160的一部分接触时,圆形缝合器10可以被认为是处于完全插入位置。
在多个实施例中,柄部组件130能够防止引导器100不正确地安装在圆形缝合器10上。例如,柄部组件130可以“具体取向”成使得其包括这样的特征物,即当缝合头部已经插入到完全插入位置时,所述特征物与圆形缝合器10的柄部12上的对应表面相匹配,同时在引导器100未正确安装时干涉其他表面。此外,多个圆形缝合器10包括位于柄部的上侧上的指示器面板19。参见图1。这样的指示器面板19可以例如向临床医生提供砧座20相对于缝合头部16的位置指示。在多个实施例中,引导器100的柄部130可以设计成覆盖或遮蔽圆形缝合器10的指示器面板19。这样的布置用来确保使用者意识到引导器100安装在缝合器10上,由此防止使用者在没有首先移除引导器100的情况下试图击发圆形缝合器10。例如,柄部组件130包括向前部分220,该向前部分220覆盖或以其他方式遮蔽圆形缝合器10的指示面板19。
在多个实施例中,释放构件122或缝合线的近端124附接到释放滑块230。从图6可以看到,缝合线122可以附接到释放滑块230的前突出部232,该前突出部232的尺寸制定为能够滑动地接纳在形成于柄部组件130的向前部分中的腔体222内。前突出部232通过覆盖件240可滑动地保持在腔体222内,该覆盖件240可以通过一系列保持器突出部242附接到柄部组件130,这些保持器突出部242被取向成与柄部组件130中的对应卡扣腔体224卡扣地接合。参见图5和图6。
本发明的多个实施例还可以包括用于使缝合线122的近侧行程距离相对于释放滑块230在圆形缝合器10的柄部12上运动的距离增大的装置。例如,多个实施例可以采用带轮式布置250来使缝合线122的行程距离相对于释放滑块230沿近侧方向“P”运动的距离增大。这样的布置可以允许较大的行程,以确保端帽构件160的释放而不需要加长柄部130。例如,如图6所示,缝合线122的近端部分124延伸穿过柄部组件130中的狭槽252,并且呈环形穿过向前滑块突出部232中的孔234。然后,缝合线122的端部124可以附接到柄部组件130上的固定柱254。
为了有助于容易地移除引导器100,释放滑块230可以设置有相对“薄型”,以便使得临床医生能够保持夹持在缝合器10的柄部12上而不会显著地改变它们将单独利用圆形缝合器10所进行的夹持或方法。参见图7-9。另外,在多个实施例中,释放滑块230可以设置有孔236和/或两个侧向翼部238。从而,这种布置允许临床医生利用孔236中的单个指状物或侧向翼部238上的两个指状物沿近侧方向“P”向释放滑块230施加力。
从图6还可以看到,柄部组件130的向前部分220还可以设置有阻挡件229,该阻挡件229布置成与在释放滑块230的前突出部232上形成的向前突出部239接合。从而,在使用中,一旦圆形缝合器10已经插入到引导器100中至完全插入位置并且缝合器10和引导器100已经插入到患者体内的期望位置,临床医生就可以沿近侧方向拉动释放滑块230,以便向缝合线122施加一定大小的张力或释放运动,以将闩锁构件140牵拉到解锁位置。释放滑块230上的进一步拉动将使得向前突出部239接触阻挡件229。一旦向前突出部239接触阻挡件229,释放滑块230沿近侧方向的进一步拉动就将使得整个引导器100沿近侧方向运动。这样的布置通过使释放滑块230在圆形缝合器10的柄部12上沿近侧方向运动而使得整个引导器100能够从缝合器10脱离并且从患者退回。引导器100从缝合器10移除可以在不从患者移除缝合器10的情况下实现。
为了使用引导器100,临床医生简单地将圆形缝合器10插入护套110中至完全插入位置并且将引导器100相对于柄部12对准,使得柄部130的向前部分220覆盖圆形缝合器10的指示面板19。为了帮助插入过程,圆形缝合器10的缝合头部16和轴部分14以及引导器100的端帽组件150和护套110可以在开始插入过程之前进行润滑。当圆形缝合器10已经正确地插入到引导器100中时,与圆筒组件152的凸缘190接合并由此保持在如图3-6、图10和图13所示的闭合位置中的端帽160的边沿将抵靠在缝合器10的缝合头部16上。然后,使用者将缝合器10和引导器100插入到结肠中期望位置处。一旦缝合器10处于期望位置,临床医生就可以沿近侧方向“P”拉动释放滑块230,这使得缝合线122将保持器闩锁140拉出而不与圆筒组件152的端部154、156接触。随着保持器闩锁140被向近侧牵拉,释放指状物145上的凸轮表面147与在圆筒组件152的相对端部154、156上形成的凸轮表面161、163配合,使得当释放构件140被沿近侧方向“P”拉动时端部154、156被沿径向推压分开。释放滑块230的进一步拉动使得向前突出部232接触阻挡件229,从而滑块230的进一步拉动使得整个引导器100被向近侧拉动越过圆形缝合器10。引导器100的这种拉动可以使得护套110沿穿孔116的线分开,并且使得端帽160运动至打开位置(图14和15),由此使得引导器100能够在击发缝合器10之前从患者退回。
图22示出了本发明的另一个引导器300。在这个实施例中,引导器300包括中空护套302,该中空护套302具有闭合端部304和用于插入到圆形缝合器10上的开放端部306。护套302可以由柔性材料制成,例如由通常用来制造避孕套的那些材料制成。在一个实施例中,护套302由单个材料部件制成,该单个材料部件具有细长接缝310,该细长接缝310延伸护套302的长度。具体地,护套材料折叠成使得材料的端部312与材料的端部314叠置由图22中距离“O”表示的部分。然后,端部312、314通过形成接缝310的缝合线316而缝合在一起。从而,护套302在插入到患者体内之前插到缝合器10的缝合头部16上。在缝合器10和护套302已经插入就位之后,可以通过拉动缝合线316以由此释放接缝310而允许移除护套302来移除护套302。在其它实施例中,护套302由两个柔性材料部件制成,该两个柔性材料部件利用两个缝合线316以上述方式缝合在一起。为了移除护套302,临床医生简单地拉动一个或两个缝合线316。
图23示出了本发明的另一个引导器320。在这个实施例中,引导器320包括中空护套322,该中空护套322具有闭合端部324和用于插入到圆形缝合器10上的开放端部326。护套322可以由柔性材料制成,例如由通常用来制造避孕套的材料制成。在一个实施例中,护套320具有闭合端部342和开放端部326,并且设置有至少一个削弱区域328,该削弱区域328可以包括延伸护套322的长度的穿孔线或接缝。从而,护套322在插入到患者体内之前插到缝合器10的缝合头部16上。在缝合器10已经插入就位之后,可以通过拉动削弱区域328以允许护套322与缝合器12分开而移除护套322。
图24-28示出了本发明的另一个引导器330。在这个实施例中,引导器330包括护套332,该护套332具有闭合远端334和开放近端336,该开放近端336的尺寸制定为伸展越过圆形缝合器10的缝合头部16的至少远侧部分。护套332可以由例如硅树脂、胶乳或其他相对较低硬度材料(即90A的硬度)制成。在多个实施例中,沿周向延伸的上升的缓冲器区域338可以围绕闭合远端334的周向形成,如图24和图25所示。在一些实施例中,中心部分335从沿周向延伸的缓冲器区域338向内延伸,以封装缝合头部16中的开放中心区域27。参见图25。
从图25还可以看到,缓冲器区域338向远侧延伸超出(或换句话讲为“上升超过”)由缝合头部16的远侧面25限定的平面D-D。在一些实施例中,缓冲器区域338由实心材料形成。参见图26。在其它实施例中,在其中形成有沿周向延伸的中空区域340。在其它实施例中,中空区域340包括多个凹部341。参见图28。区域340和凹部341可以填充有空气或液体,例如盐水溶液。在使用中,护套332在缝合器10的缝合头部16上方卷绕。护套332可以在闭合和击发缝合器10时被留下就位,在这种情况下,区域340或凹部341将破裂而仅仅留下护套材料处于直肠内腔内的缝钉冠部下方。
图29示出了本发明的另一个引导器350。在这个实施例中,引导器350包括护套352,该护套352具有远端354和开放近端356,该开放近端356的尺寸制定为在圆形缝合器10的缝合头部16上方伸展。护套352可以由例如硅树脂、胶乳或其他相对较低硬度材料(即90A的硬度)制成。在多个实施例中,沿周向延伸的上升缓冲器区域357可以围绕护套352的周向形成,使得其覆盖缝合头部16的远侧面25并且一部分359延伸到开放中心区域27中且处于由远侧面25限定的平面D-D之下。参见图29。在一些实施例中,缓冲器区域357由实心材料形成。在其它实施例中,在其中形成有沿周向延伸的中空区域358。中空区域358可以填充有空气或液体,例如盐水溶液。在其它实施例中,沿周向延伸的中空区域358被分段(如,包括绕护套352的周向延伸的一系列离散的凹部)。离散的凹部可以填充有空气或液体,例如盐水溶液。在使用中,护套352在缝合头部16的远端部分上方卷绕。护套352可以在闭合和击发缝合器10时被留下就位,在这种情况下,中空区域358或凹部将破裂而仅仅留下护套材料处于直肠内腔内的缝钉冠部下方。
图30-32示出了本发明的另一个引导器360。在这个实施例中,引导器350包括覆盖件362,该覆盖件362的尺寸制定为安装在缝合头部16的至少远侧部分上。在一个实施例中,覆盖件362包括C形本体部分363,该本体部分363可以由例如聚氨酯共混物、聚酯、聚乙烯、聚碳酸酯或聚丙烯制成,并且其尺寸制定为卡扣到缝合头部16和圆形缝合器10细长轴14的一部分上。参见图31。在多个实施例中,本体部分363的远端364具有至少三个通常闭合的指状物366,当在缝合头部16上向远侧运动时,这些指状物闭合在一起,以形成例如“郁金香状”的形状,以用于插入到肛门中。参见图30。本体部分363上可以形成具有回缩构件370,以便于向该本体部分363实施回缩运动。当缝合器10已经到达其目标插入点时,覆盖件362可以被朝向缝合器10的柄部12拉动,从而将指状物366拉到缝合头部16的竖直侧,以暴露钉仓17的远侧面25。参见图32。
图33和34示出了本发明的另一个引导器380。在这个实施例中,引导器380包括覆盖件382,该覆盖件382包括四个指状物384,这些指状物384从居中地设置的毂386延伸,该毂386具有贯穿的套管针进入孔388。每个指状物384的近端390上都形成具有保持凸缘392,该保持凸缘392延伸到中心开口27中并且接合缝合头部16的中心壁部分21。为了安装覆盖件382,覆盖件382定位在缝合头部16上方,如图33和图34所示,并且圆形缝合器10的套管针23前进,使得套管针23的远端部分35突出穿过中心毂386中的孔388。一旦就位,套管针23就向近侧缩回到中心开口27中,由此迫使指状物384形成为大致球状“蘑菇状的”横截面形状。一旦缝合器10定位在直肠中,套管针23就可以展开并且被推过直肠壁,以允许触及能够从套管针23移除的附属指状物384。
图35-37示出了本发明的另一个引导器400。在这个实施例中,引导器400包括覆盖件402,该覆盖件402包括四个指状物404,这些指状物404通过护套410附接在一起。参见图35。护套可以由例如硅树脂材料形成。护套410的顶端区域412可以具有贯穿其的套管针进入孔414。每个指状物404的近端406上都形成具有保持凸缘408,该保持凸缘408延伸到缝合头部16的中心开口21中。为了安装覆盖件400,覆盖件402定位在缝合头部16上方,如图35和图36所示,并且圆形缝合器10的套管针23向远侧前进,使得套管针23的远端部分35突出穿过护套410中的孔414。一旦就位,套管针23就缩回,由此迫使指状物404形成为大致蘑菇状横截面形状。参见图37。一旦缝合器10定位在直肠中,套管针23就可以展开并且被推过直肠壁,以允许触及能够从套管针23移除的附属指状物404。
图38示出了另一个引导器420,该引导器420可以由例如聚氨酯共混物、聚酯、聚乙烯、聚碳酸酯或聚丙烯制成,具有在毂或顶端区域424处互相连接的至少四个指状物422。指状物422的近端426卡扣到缝合头部16上。在这个实施例中,引导器420设计成到达结肠,然后被移除。这与上述引导器400不同,其中套管针处于延伸位置以将其保持就位,直到该装置就位,然后将套管针带到近侧。
图39和40示出了可以与圆形缝合器10结合使用的另一个引导器500。从这些图中可以看到,引导器500可以包括具有穿孔的模制构造并且可以由例如聚氨酯共混物、聚酯、聚乙烯或聚丙烯制成,或者可以包括缠绕带,该缠绕带缝合在一起或保持就位而不进行覆盖。带504的宽度可以为例如250英寸,并且其厚度可以为例如0.020英寸。带504可以形成基座部分506,该基座部分506的尺寸制定为绕缝合头部16的周向延伸。基座部分506的尺寸可以相对于缝合头部16制定为使得当以闭合螺旋的关系保持在一起时螺旋带504与缝合头部16形成相对较紧的(过盈)配合,以将引导通道保持在其上。螺旋缠绕带504形成多个相继的通道508,该通道508渐缩成钝的远端510。从图36可以看到,一个实施例与端部钝的“蜂窝形”类似,基本上封装或覆盖缝合头部16的远侧面。螺旋通道508可以通过保持器构件510保持为基本上邻接的关系(即螺旋缠绕端部闭合的关系)。在多个实施例中,保持器构件510可以包括延伸越过引导器500的收缩包裹的薄(例如1到4密耳)层。引导器500还包括释放构件520,该释放构件520附接到带材料504,使得在向其实施释放运动时,螺旋缠绕带构件504从与缝合头部16的远侧部分的接合退绕。例如,在一个实施例中,释放构件包括释放缝合线520,该释放缝合线520附接到带504的远端512。释放缝合线520可以穿过带504的形成基座部分506的部分中的孔522,并且向近侧延伸出去而到缝合器10的柄部,以便使得释放缝合线520能够被临床医生抓握。
引导器500可以借助缝合器10的供应器通过将引导器500收缩包裹到缝合头部16而进行安装。在使用中,临床医生将缝合器和引导器组件530插入患者的肛门内并且通过直肠瓣而到达期望区域。一旦临床医生已经确定缝合器10处于期望位置,临床医生就可以沿近侧方向“P”拉动释放缝合线520,这使得收缩包裹510破裂,从而允许引导器500退绕,如图40所示。释放缝合线520上的连续拉动将使得引导器500能够从患者退回。
图41-43示出了可以与圆形缝合器10结合使用的另一个引导器600。从这些图可以看到,引导器600可以具有基座部分602,该基座部分602的尺寸制定为保持在缝合头部16上。引导器600形成具有多个锥形的“花瓣”部分504,该部分504渐缩成基本上圆形的点606。例如,在一些实施例中,具有四个沿直径方向相对的花瓣部分604,当闭合(图41)时,花瓣部分604会聚以形成尖端较相对钝的端部610。花瓣部分604之间具有开放区域612。在多个实施例中,花瓣部分604通过可释放的保持器构件620保持在闭合位置中。例如在一些实施例中,保持器构件包括围绕引导器600施加的收缩包裹材料620。在一些实施例中,可以围绕基部602的内周边形成多个保持壁架630,以便在已经施加了收缩包裹620时接合缝合头部16的远侧面25。释放缝合线640可以通过收缩包裹620的覆盖开放区域612的那些部分622进行缝合。释放缝合线640终止于或均附接到释放缝合线650,该缝合线650穿过基座部分602中的孔652并且向近侧延伸出去而到缝合器10的柄部,以便使得释放缝合线650能够被临床医生抓握。
引导器600可以借助缝合器10的供应器通过将引导器600收缩包裹到缝合头部16而进行安装。在使用中,临床医生将缝合器和引导器组件660插入患者的肛门内并且通过直肠瓣而到达期望区域。一旦临床医生已经确定缝合器10的缝合头部处于期望位置,临床医生就可以沿近侧方向“P”拉动释放缝合线650,这使得收缩包裹620破裂,从而允许引导器600被向远侧拉过缝合头部16,如图43所示。
图44-46示出了可以与圆形缝合器10结合使用的另一个引导器700。从这些图可以看到,引导器700可以由例如聚氨酯共混物、聚酯、聚乙烯或聚丙烯制成,并且具有基座部分702,该基座部分702的尺寸制定为保持在缝合头部16上。引导器700形成具有多个锥形的“区段”部分704,该部分704渐缩成基本上圆形的点706。例如,在一些实施例中,具有四个沿直径方向相对的区段部分604,当闭合(图44)时,区段部分604会聚以形成尖端相对较钝的端部710。在图44-46所示的实施例中,引导器700包括四个区段部分704。区段部分704在它们的基座部分处相互连接,除了两个相邻的区段部分704之外,其中两个区段部分704的基部没有附接在一起。更具体地,区段部分704A具有基部边缘705A并且区段部分704B具有基部边缘705B。边缘705A和705B彼此没有附接。从而,区段部分704A和区段部分704B包括基座部分702的自由端部。自由端部704A和704B通过保持器构件保持为邻接的关系,该保持器构件为径向释放突出部720的形式,附接到704A和704B。在多个实施例中,释放突出部720固定或模制到区段部分704A,并且可以不必从该区段部分704A移除。释放突出部720可释放地附接到区段部分704B。释放突出部720可以通过可释放的保持物722附接到区段部分704,该可释放的保持物722为例如可剥离粘合剂或可破裂材料片。当释放突出部720如图41所示地附接时,区段部分704形成环形基座部分702,该环形基座部分702可以固定地卡扣到或以其他方式固定地接合圆形缝合器10的缝合头部16。释放缝合线730附接到释放突出部720并且向近侧延伸出去而到缝合器10的柄部12,以便使得释放缝合线730能够被临床医生抓握。
引导器700可以通过临床医生卡扣到或按压到缝合头部16上。在使用中,临床医生将缝合器和引导器组件740插入患者的肛门内并且通过直肠瓣而到达期望区域。一旦临床医生已经确定缝合器10的缝合头部16处于期望位置,临床医生就可以沿近侧方向“P”拉动释放缝合线730,这使得释放突出部720从区段部分704B释放,以便使得引导器700能够从缝合头部16释放。释放缝合线730上的继续拉动将使得引导器700能够从患者退回。
从而,本发明的圆形缝合器引导器的多个实施例可以有助于经肛门和经腹部的插入和导向,以能够在低前位切除术中触及远侧肢体的缝钉线。各种引导器可以设置成还包括圆形缝合器10的套件的一部分。引导器的多个实施例将不会与圆形缝合器的当前功能发生冲突。
本发明的多个实施例体现了对现有圆形缝合装置的大幅改进,现有圆形缝合装置不具有将砧座锁定在击发位置的任何装置。虽然已经描述了本发明的若干实施例,但应当知道,掌握了本发明的一些或全部优点的本领域的技术人员可能会想到这些实施例的各种修改、变型和变通形式。例如,按照多个实施例,单个部件可以替换为多个部件,并且多个部件也可以替换为单个部件,以执行给定的一种或多种功能。因此,在不脱离所附权利要求书限定的已公开发明的范围和精神的情况下,本专利申请旨在涵盖所有这类修改、变型和变通形式。
以引用方式全文或部分地并入本文的任何专利、公布或其它公开材料都仅在所并入的材料不与本发明所述的现有定义、陈述或其它公开材料相冲突的范围内并入本文。同样地并且在必要的程度下,本文明确阐述的公开内容取代了以引用方式并入本文的任何冲突材料。如果任何材料或其部分据述以引用方式并入本文,但与本文所述的现有定义、陈述或其它公开材料相冲突,那么仅在所并入的材料和现有公开材料之间不产生冲突的程度下才将其并入本文。
旨在受到保护的本发明不应被理解为受所公开的具体实施例的限制。因此应将这些实施例看作是示例性而非限制性的。在不脱离本发明精神的情况下,其他人可以进行更改和修改。因此,需要明确指出的是,本发明应涵盖落入权利要求书所限定的本发明的精神和范围内的所有这些等同形式、变型形式和修改。
Claims (17)
1.一种引导器,所述引导器用于将外科圆形缝合器引导到患者体内,所述外科圆形缝合器具有柄部、从所述柄部突出的细长轴以及与所述细长轴联接的缝合头部,所述引导器包括:
中空柔性护套,所述中空柔性护套具有远端和开放近端,所述中空柔性护套的尺寸形成为在其中接纳所述细长轴的至少一部分和所述缝合头部;
可沿径向打开的圆筒构件,所述可沿径向打开的圆筒构件附接到所述中空柔性护套的远端并且限定开口,所述开口用于在其中接纳所述缝合头部,
刚性端帽构件,所述刚性端帽构件可铰接地附接到所述可沿径向打开的圆筒构件并且能够在闭合位置和打开位置之间运动,在所述闭合位置中,所述刚性端帽构件覆盖所述圆筒构件中的所述开口的远端,在所述打开位置中,所述刚性端帽构件能够运动到暴露所述圆筒构件中的所述开口的所述远端的位置;以及
闩锁构件,所述闩锁构件与所述可沿径向打开的圆筒构件的一对相对的端部接合,所述闩锁构件能够选择性地从闩锁位置和解锁位置运动,在所述闩锁位置使所述圆筒构件的所述相对的端部接合并且将所述刚性端帽构件保持在所述闭合位置中,在所述解锁位置中,所述相对的端部能够沿径向彼此远离地运动,以使得所述刚性端帽构件能够运动到所述打开位置。
2.根据权利要求1所述的引导器,其中所述闩锁构件包括:
闩锁本体;
第一闩锁突出部,所述第一闩锁突出部从所述闩锁本体突出并且具有第一部分,所述第一部分能够插入到第一闩锁腔体中,所述第一闩锁腔体设置在所述圆筒构件的所述相对的端部中的一个端部中;以及
第二闩锁突出部,所述第二闩锁突出部从所述闩锁本体突出并且具有第二部分,所述第二部分能够插入到另一个闩锁腔体中,所述另一个闩锁腔体处于所述圆筒构件的所述一对相对的端部中的另一个端部中,使得当所述第一闩锁突出部处于所述第一闩锁腔体中且所述第二闩锁突出部处于所述第二闩锁腔体中时,所述圆筒构件形成环状结构,所述环状结构的尺寸形成为在其中容纳所述缝合头部。
3.根据权利要求2所述的引导器,所述引导器还包括所述闩锁本体上的释放指状物,所述释放指状物能够在所述闩锁构件运动到解锁位置时接合所述一对相对的端部的各部分,由此将所述一对相对的端部沿径向彼此分隔开地推压。
4.根据权利要求3所述的引导器,其中所述释放指状物居中地设置在所述第一闩锁突出部和第二闩锁突出部之间,并且其上还具有一对中心凸轮表面,其中当所述闩锁构件运动到所述解锁位置时,一个所述中心凸轮表面能够以凸轮的方式接合所述相对的端部中的一个端部上的对应端部凸轮表面,所述中心凸轮表面中的另一个能够以凸轮的方式接合所述相对的端部中的另一个端部上的另一个端部凸轮表面。
5.根据权利要求1所述的引导器,所述引导器还包括向内延伸的保持凸缘,所述向内延伸的保持凸缘形成在所述可沿径向打开的圆筒构件的至少一部分的内侧表面上,所述保持凸缘能够固定地接合所述刚性端帽构件的一部分,以将所述刚性端帽构件保持在所述闭合位置中。
6.根据权利要求5所述的引导器,其中所述刚性端帽构件上具有至少一个保持肋,所述至少一个保持肋取向成当处于所述闭合位置时用于与所述可沿径向打开的圆筒位置上的所述向内延伸的保持凸缘保持接合。
7.根据权利要求6所述的引导器,其中所述至少一个保持肋上具有至少一个斜切表面,以便在所述闩锁构件已经运动到所述解锁位置时有助于与所述向内延伸的保持凸缘脱开。
8.根据权利要求1所述的引导器,使得当所述缝合头部在所述引导器内处于完全插入位置时,所述刚性端帽构件的至少一部分接触所述缝合头部的远侧面。
9.根据权利要求2所述的引导器,其中所述圆筒构件的所述一对相对的端部之间限定用于在其中接纳所述闩锁构件的闩锁区域,并且其中所述端帽构件通过拴系件可铰接地附接到所述圆筒构件,所述拴系件在基本上与所述闩锁区域沿直径方向相对的位置中附接到所述圆筒构件。
10.根据权利要求2所述的引导器,其中所述圆筒构件的所述一对相对的端部之间限定用于在其中接纳所述闩锁构件的闩锁区域,并且其中所述端帽构件通过拴系件可铰接地附接到所述圆筒构件,所述拴系件在定位成与所述闩锁区域基本上成直角的位置中附接到所述圆筒构件。
11.根据权利要求5所述的引导器,所述引导器还包括至少一个角撑板构件,所述至少一个角撑板构件附接到所述向内延伸的保持凸缘和所述可沿径向打开的圆筒构件的至少一部分的所述内侧表面。
12.根据权利要求2所述的引导器,其中所述闩锁构件可运动地支承在形成于所述中空柔性护套中的内腔内。
13.根据权利要求2所述的引导器,所述引导器还包括释放构件,所述释放构件附接到所述闩锁构件的所述本体部分,并且向近侧延伸超出所述中空柔性护套的所述开放近端。
14.根据权利要求12所述的引导器,所述引导器还包括释放构件,所述释放构件附接到所述闩锁构件的所述本体部分,并且穿过所述内腔延伸到护套的所述开放近端。
15.根据权利要求14所述的引导器,其中所述释放构件包括缝合线。
16.一种引导器,所述引导器用于将外科圆形缝合器引导到患者体内,所述外科圆形缝合器具有柄部、从所述柄部突出的细长轴以及与所述细长轴联接的缝合头部,所述引导器包括:
中空柔性护套,所述中空柔性护套具有远端和开放近端,所述中空柔性护套的尺寸形成为在其中接纳所述细长轴的至少一部分和所述缝合头部;
可沿径向打开的圆筒构件,所述可沿径向打开的圆筒构件附接到所述中空柔性护套的远端并且限定开口,所述开口用于当所述可沿径向打开的圆筒构件处于闩锁位置时在其中接纳所述缝合头部,
刚性端帽构件,所述刚性端帽构件可铰接地附接到所述可沿径向打开的圆筒构件,并且能够在闭合位置和打开位置之间运动,在所述闭合位置中,所述刚性端帽构件保持在当所述缝合头部已经插入到所述刚性端帽构件中至完全插入位置时覆盖所述缝合头部的远侧面的位置中,所述打开位置暴露所述缝合头部的所述远侧面;以及
闩锁装置,所述闩锁装置用于将所述可沿径向打开的圆筒构件的相对的端部可释放地保持在所述闩锁位置中,并且在向所述闩锁装置实施释放运动时,将所述可沿径向打开的圆筒构件的所述相对的端部彼此远离地推压到解锁位置。
17.根据权利要求16所述的引导器,其中所述相对的端部沿径向方向运动,所述径向方向基本上与所述释放运动施加到所述闩锁装置的方向成横向。
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