CN101484078A - 外科钉合器械 - Google Patents
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Abstract
一种外科钉合器械(1)，包括位于所述器械的远侧区域中的钉紧固组件(4)，所述钉紧固组件(4)包括仓装置(8)和砧座(9)，该仓装置(8)包括闭合的至少一个钉排(17、18)并限定波浪形的远端面(14)，所述砧座(9)限定有与所述远端面(14)大致匹配的波浪形的近侧钉成形表面(20)，并且砧座(9)能够与所述仓装置(8)协同动作以便使从所述仓装置(8)排出的钉的端部成形，其中所述远端面(14)和所述钉成形表面(20)具有总体波浪形状，该波浪形状包括两个相对的波峰(21)和与相邻波峰(21)间隔大约90°角的两个相对的波谷(22)，并且两波峰－两波谷的波浪形状由所述远端面(14)和所述钉成形表面(20)的阶梯构型形成。
Description
技术领域
本发明涉及一种外科钉合器械，其可被用于将外科钉或夹具应用到组织。特别是，本发明涉及一种用于形成吻合的腔内外科钉合器械。
背景技术
外科钉合作为连接和修复组织的快速有效方式在本领域是已知的，并且外科钉合已经不仅是可接受的，而且是缝合的优选替代方式。
已知的腔内外科钉合器械典型地包括细长轴，该轴具有近侧致动机构和安装在轴上的远侧钉紧固组件。钉紧固组件典型地包括钉仓装置，该钉仓装置容纳有设置成圆形闭合阵列的多个钉。具有闭合切割边缘的圆形切割刀被包含在仓装置内并被定位成使得切割边缘的外侧存在至少一个闭合的钉排。刀可在手术过程中沿着轴向向远侧行进。套管针轴从仓装置向远侧延伸并可相对于仓装置轴向运动。砧座可拆卸地安装在套管针轴上并包括钉成形表面，该钉成形表面朝向仓装置的远端面并适于通过钉驱动装置抵靠砧座推动钉来形成钉的端部。仓的端面与砧座钉成形表面之间的距离可通过调节调节机构而变化，该调节机构安装在套管针轴近端上并被构造成使套管针轴与砧座一起相对于钉仓装置运动。致动机构典型地将钉驱动操作与刀的行进操作相联系，使得当致动机构由外科医生触发时，容纳在钉仓装置与砧座之间的组织同时被钉合和切割。
一般说来，在腔内吻合执行过程中，两部分腔或管状组织(例如肠组织)通过闭合的钉排连接在一起。在使用外科钉合器械进行吻合过程中，砧座被设置在远侧腔或组织部分的近端中(从外科医生的视点看)，并且仓装置被放置在待连接的近侧腔或组织部分的远端中。砧座和仓装置的放置可通过将它们经由外科医生切割相应的腔形成的入口***来进行，或者通过将它们经内窥镜(例如经***通过直肠)***来进行。在吻合中预定待连接的腔或组织部分可使用缝线或者其他传统打结技术系到砧座轴和/或套管针轴上。此后，砧座轴与钉紧固组件(仓装置)的套管针轴连接并且仓装置与砧座之间的间隙被闭合，从而将近侧组织部分和远侧组织部分一起夹在间隙中。当致动腔内钉合装置时，一排或多排闭合的钉被从仓装置的相应的钉引导槽驱动出来。钉被驱动通过远侧和近侧组织部分并抵靠砧座的钉成形槽的阵列成形，从而将组织部分连接起来并形成管状通路。
同时，当钉被施加并成形时，圆形刀向远侧行进以切割钉的内部环形钉排附近的过量组织。然后，通过闭合的钉排连接的组织边缘通过相对于仓装置向远侧行进套管针轴而被松开，使砧座运动远离仓装置。然后通过经由被环形钉合的组织边缘限定的吻合孔向近侧拉动砧座使钉合器械从吻合部位退出。
虽然已知的外科钉合器械的使用非常有利并且极大地方便了吻合的执行，但其也涉及一些问题。通常难以从手术部位回缩器械，因为难以经过由闭合钉排限定的略显坚硬的吻合口退出砧座。此外，在手术后，吻合部位处的临床狭窄的出现也不少见。
为了克服这些已知缺陷，在WO01/54594A1中建议以波浪形布置闭合钉排。在该方式中，闭合钉排设置的线比该线在平面上的投影具有更大的总长度。因此，吻合接缝的长度大于通过传统钉合器械形成的吻合的长度。由于该增加的长度，吻合部位可采取更大的直径并且更具有柔性，于是砧座可更容易地运动通过吻合开口。另外，得到的更大的吻合腔可消除临床并发症的发生。
但是，钉布置的波浪形状具有一些缺点。为优化钉合器械的性能，单个钉从仓装置中沿着垂直于波浪形状的局部斜面的方向被排出，而该斜面一般与器械的纵向轴线不平行，因而要求复杂的钉合驱动装置。此外，由于钉驱动方向相对于砧座接近方向(钉合器的轴向)的倾斜朝向，砧座处的钉成形槽和仓装置的钉引导槽的对准随着仓装置与砧座之间的距离的任何变化发生不期望的变化，从而将钉合器的使用限制成仅仅用于吻合中待连接组织的一种厚度。
此外，由于波浪形钉合接缝的长度仅仅能通过增加沿着圆形钉线的波浪的数目以及增加波浪的幅值(轴向延伸)而增加，波浪形圆形钉合器的应用遇到了与身体组织的生理特征有关的一些限制。通过增加沿着钉线的波浪数目(在给定幅值)，相邻组织部分的倾斜的斜率或者弯曲增加到可能导致组织损伤或者局部破裂的程度。另一方面，使用仅仅具有单个正弦波的钉线，波浪的幅值(即单个波浪的波谷与波峰之间的距离)需要非常高，以便得到所需的钉合接缝的长度增加。由于人体和动物体的一些管状器官，特别是肠，具有单向血液供给，相对于腔的较大纵向延伸的吻合可能导致一些组织区域完全没有血液供给，导致坏死。
发明内容
本发明的一个目的在于提供一种用于进行吻合的外科钉合器械，其协调使钉合接缝的长度最大化与使组织损伤最小化并降低钉驱动装置的复杂性的矛盾要求。本发明的另一个目的在于提供一种适于不同组织厚度的外科钉合器械。
这些目的通过具有权利要求1的特征的外科钉合器械来实现。本发明的有利实施方式和变型遵循从属权利要求。
根据本发明的外科钉合器械包括具有主体部分和手柄的机架以及处于器械的远侧区域中的钉紧固组件。钉紧固组件包括：容纳至少一个闭合钉排并限定波浪形远端面的仓装置，和限定与波浪形远端面匹配的波浪形钉成形表面的砧座。砧座可相对于仓装置运动并适于与仓装置协同动作以便使从仓装置排出的钉的端部成形。运动装置适于使砧座相对于仓装置运动。钉驱动装置适于驱动钉向着砧座离开仓装置。具有闭合切割边缘的刀被容纳在仓装置中并被定位成使得在切割边缘的径向外侧上存在至少一个闭合钉排。刀致动装置适于使刀向着砧座运动。
根据本发明，远端面和钉成形表面都具有波浪形状以及阶梯式或偏移构型，该波浪形状包括两个相对的波峰和与相邻波峰间隔大约90°角的两个相对的波谷，该阶梯式或偏移构型用于形成两波峰-两波谷的波浪形状。
阶梯表面由一系列接触面(land)和竖立面(riser)构成，其中接触面与钉紧固组件的纵向轴线基本上垂直，并且钉引导槽的出口以及钉成形槽有利地形成于接触面中。
阶梯表面构造在大致两波峰-两波谷的波浪形构造周围“振荡(oscillate)”，从而进一步增加钉合接缝相对于钉合装置的尺寸的长度，而基本上不增加吻合的沿着腔的总轴向延伸部分。此外，阶梯构造和所有与纵向轴线垂直的阶梯接触面的朝向允许将所有的钉设置为与钉驱动装置的钉驱动方向平行，从而减小了穿刺组织并抵靠砧座的钉成形表面扭弯钉所需的力。
有利地，钉在仓装置中沿着波浪线设置，该波浪线包括两个相对的波峰和与相邻的波峰间隔大约90°角的两个相对的波谷，其中钉沿着其设置的线大体上与仓装置的相应远端面平行。优选地，仓远端面和钉成形表面的在垂直于钉紧固组件的纵向轴线的平面上的投影以及钉线在垂直于钉紧固组件的纵向轴线的平面上的投影为圆形。
因此，外科钉合器械的组织界面具有比相应的平面或者光滑的波浪形组织界面更大的总体延伸部分。具有两个相对波峰和与相邻波峰间隔大约90°角的两个相对的波谷的特定形状允许获得与传统圆形钉合器相比增加的钉合接缝长度，而不需要增加组织弯曲的斜率以及吻合的沿着腔的总体纵向延伸部分，从而降低了损伤和组织破裂的风险。钉合接缝的长度通过在两波峰-两波谷的波浪形状附近“振荡”的仓端面和钉成形表面的局部阶梯或者偏移的表面构型进一步增加。除增加钉合接缝的长度而基本上不增加吻合的纵向延伸部分之外，这种双波形的模式(整体的大致波浪形和局部的阶梯形)的叠加允许进一步对准阶梯，并且因此容纳钉的引导槽的方向与钉紧固组件的纵向轴线平行，进而允许简单坚固的钉驱动装置的使用。
根据本发明的重要方面，远端面和匹配的钉成形表面的波峰和波谷之间的轴向距离优选小于20mm，更优选小于10mm。这种尺寸设置可进一步降低组织由于血液供给不足而坏死的风险。
根据本发明的又一方面，钉紧固组件的尺寸以下列方式设置：至少砧座的外周小于或者大致等于沿着钉线的两波峰-两波谷的阶梯表面的总长度。对腔直径的要求与钉合器从吻合部位退出过程中使组织张紧最小化的要求之间的非常好的折中方案可通过在0.95到1.02之间选择砧座的外周长度(并优选钉仓装置的外周长度)与钉线长度的比率而获得。
再次，远端面和钉成形表面的大致两波峰-两波谷的波浪形状可通过不同几何结构得到。规则的正弦波模式导致沿着钉线的组织弯曲斜率的逐渐变化。具有圆滑角的Z字形导致相对的波峰和波谷的区域中组织弯曲的集中并导致各个波峰和波谷之间的大体上平坦的中间区域，在这些区域中基本上没有组织弯曲。作为替代，远端面可有利地由沿着圆形钉仓装置的直径相交的两个平面限定，并且钉成形表面可有利地由沿着砧座的直径相交的两个平面限定。在这种情况下有利的是使两个半平面的相交区域圆化。这将导致大体上为鱼嘴形状的表面。
由于上述组织夹紧表面和外科钉合器械的钉线的几何形状，吻合部位可采取更大的直径并更具有柔性，于是砧座可以很容易通过由刀形成的开口除去，并且外科钉合器械可更容易地被回缩。另外，临床并发症的发生可被减少。
此外，由于单个阶梯的接触面(其限定了钉引导槽的出口)相对于钉紧固组件的纵向轴线的垂直朝向，从仓装置排出的钉的尖端保持与砧座上提供的钉成形槽对准，而与砧座和仓装置之间的实际距离或者被夹钳在它们之间的组织的厚度无关。
可以想到的是，刀具有带有圆形切割边缘的传统的(圆柱形)基本形状，在本发明的优选方案中限定刀的切割边缘的线具有两波峰-两波谷的大致波浪形状或者鱼嘴形状(具有在垂直于钉紧固组件的纵向轴线的平面上的圆形投影)。切割边缘优选由在其波浪形状周围“振荡”并与一个或多个钉排沿着其设置的线平行的一系列阶梯限定。使用这种设计，刀仅需被运动非常短的距离以便完全切割被夹紧在仓装置与砧座之间的组织。
在本发明的有利方案中，钉紧固组件可拆卸地安装在主体部分的远端区域中。这例如使得在外科手术过程中钉形成组件能够被替换或者能够被设计为一次性部件(而包括机械元件的主要部件的机架可灭菌并重新使用)。此外，仓装置可包括容纳钉的可拆卸的仓，例如如果需要使空仓可被新仓替换，或者仓装置可被设计为可重复使用的元件。
通过示出本发明的实施方式的附图及其描述与上面给出的本发明的一般描述和下面给出的用于解释本发明的原理的实施方式的详细描述，可以理解本发明的这些和其他特征和优点。
附图说明
图1是根据本发明的外科钉合器械的从侧面看的透视图；
图2是图1中的钉合器械的钉紧固组件的放大的远侧横向透视图；
图3和图3A分别是根据本发明一种实施方式的外科钉合器械的钉驱动装置的远侧横向透视图和侧视图；
图4是根据本发明一种实施方式的外科钉合器械的钉仓装置的远侧横向透视图；
图5A和图5B分别是处于回缩和伸出(钉被排出)构型的根据本发明一种实施方式的外科钉合器械的钉紧固组件的侧视图；
图6A、图6B、图6C和图6D分别是本发明的接近和钉合操作的侧视图。
具体实施方式
参照附图，图1显示了腔内外科钉合器械1。钉合器械1包括机架，该机架具有包括弧形或直线形的轴2的主体部分和手柄3。钉紧固组件4优选可拆卸地安装在轴2的远端，以便允许将钉紧固组件从轴2除去并在需要时由另一个钉紧固组件替换。
致动器扳机5定位在钉合器械1的近侧区域中。该致动器扳机5可向着手柄3被旋转以便“击发”钉合器械1，即用于操作钉驱动装置和钉合器械的内部机构的刀致动装置。可旋转的调节旋钮6被提供用于轴向移动套管针轴7，以便打开或关闭钉紧固组件4，即，以便使钉合器械1的砧座运动。
钉紧固组件4包括仓装置8(在该实施方式中，该仓装置8包括两个闭合的钉排)和砧座9。砧座9可拆卸地连接到可相对于仓装置8运动(即沿着钉紧固组件4的纵向轴线X运动)的套管针轴7的远端10，以便调节砧座9与仓装置8之间的间隙的尺寸。
仓装置8包括外壳11，外壳11容纳钉、圆形刀、以及(适于使套管针轴7相对于仓装置8运动的)运动装置的元件、(适于驱动钉向着砧座9离开仓装置8的)钉驱动装置和(适于使刀向着砧座9运动的)刀致动装置。仓装置8的远端面14(即从仓装置8出来的钉向着砧座9被排出的表面)形成于由外壳11的圆周壁容纳的远端部分12中。
如同已经在上面解释的那样，钉紧固组件4可以通过设置在仓装置8的近端区域处的连接部分13可拆卸地安装在钉合器械的轴2上。术语“近侧”和“远侧”以在钉合器械的正常使用过程中外科医生的观察为参照。
图2是钉紧固组件4的放大的远侧横向视图。钉仓装置8的远端面14包括引导槽15、16，它们可容纳钉(未显示)并且当钉合器械被“击发”时钉可从它们中向着砧座9被排出。这些引导槽15、16被布置成两个闭合排，由此限定了钉的径向外侧闭合排17(即引导槽15)和钉的径向内侧闭合排18(即引导槽16)。
如图2中所示，引导槽15以及外侧闭合排17的相应钉和引导槽16以及内侧闭合排18的相应钉周向交错并优选部分地重叠。
钉引导部件(在附图中被遮住)定位在远端部分12的下面并限定了用于引导外侧闭合排17的钉的引导槽15和用于引导内侧闭合排18的钉的引导槽16。这些引导槽15、16的每个容纳一个钉，钉的尖端朝向远端面14中的相应出口。钉引导部件以及远端部分12优选由医疗级树脂通过注塑成型制成并可作为单个元件整体制造。
圆形刀(在图中没有显示)在仓装置8的远端部分12的内周处被引导(以传统方式)。当钉合器械如同传统圆形钉合器通常被致动的那样被致动时，该圆形刀沿着远侧方向运动。
砧座9包括向近侧延伸的砧座轴19，砧座轴19被构造成与套管针轴7可拆卸地接合并将砧座9相对于仓装置8以一定角度对准。砧座还包括朝向近侧的环形的钉成形表面20，该钉成形表面20限定了用于每个钉的一对钉成形槽，以便在钉驱动装置致动时当钉被推靠到钉成形表面20上时使钉的尖端弯曲。仓装置的远端面14和砧座的钉成形表面20构成相对的组织界面，所述组织界面将会直接与组织接触并将组织夹在仓装置与砧座之间的缝隙中。
总的说，外科钉合器械的整个设计和机械元件、驱动机构以及安全零件与已知的圆形钉合器械相同(与例如US5309927和WO01/54594比较)；但是组织界面的三维形状以及钉线和钉驱动装置的一些细节是不同的(将在下面解释)。
仓装置的远端面14和砧座的钉成形表面20具有大致波浪形状，该波浪形状包括两个相对的波峰和以大约90°角间隔的相对的波谷22，其中该两波峰-两波谷的波形通过在两波峰-两波谷的波浪形状周围“振荡”的局部阶梯或者偏移构型得到。特别是，阶梯形的远端面14包括一系列接触面23和竖立面24，其中接触面23与钉紧固组件4的纵向轴线X垂直，并且引导槽15、16的出口形成于接触面23中。类似地，砧座的钉成形表面20也包括一系列接触面25和竖立面26，其中接触面25与钉紧固组件4的纵向轴线X垂直，并且钉成形槽被形成于接触面25中。
在远端面14和钉成形表面20的两者中，接触面23、25与竖立面24、26成钝角，以便在夹紧和钉合过程中降低局部组织张力。
所有钉引导槽15、16以大致垂直于相应的接触面23并与纵向轴线X平行的方向延伸。
结果，容纳在引导槽中的所有钉相对于与纵向轴线X一致的钉驱动装置(将在下面描述)的钉驱动方向平行对准。
根据优选实施方式，钉在仓装置8中沿着波浪线布置，该波浪线包括两个相对的波峰和与相邻波峰间隔大约90°角的两个相对的波谷，其中钉沿着其布置的线与远端面14基本上平行。为了限制钉紧固组件的直径，组织界面的所描述的波浪和阶梯形状偏离垂直于纵向轴线X的平面中的理想圆形参考形状，所述偏离仅仅是沿着垂直于该平面的方向，从而使得远端面14和钉成形表面20以及由外侧钉排17和内钉排18限定的环形线在该平面上的投影为圆形。
如同从附图中看到的那样，根据优选实施方式，两个波峰21具有距垂直于纵向轴线X的平面相同的轴向距离。类似地，两个波谷22也具有距垂直于纵向轴线X的平面相同的轴向距离。优选地，两波峰-两波谷的波浪形状和远端面14以及钉成形表面20的叠置的局部阶梯形状相对于由纵向轴线X和两个波谷22的点限定的第一平面对称，并相对于由纵向轴线X和两个波峰21的点限定的与第一平面垂直的第二平面对称。对于给定的目标钉线长度，这进一步减小了得到的吻合的纵向延伸部分。波峰21和波谷22之间的轴向距离应优选小于20mm，甚至更优选小于10mm，以便降低由于血液供给不足导致的组织坏死风险。
虽然前面的描述基本上集中在组织界面的几何形状和钉合器械1的钉线几何形状，在本发明的优选实施方式中，外科钉合器械的总体尺寸设置依赖于上面描述的波浪形状和阶梯形几何形状，使得至少砧座9的外周小于或大致等于沿着钉线的组织界面的总长度。最好的结果通过选择砧座的外周长度(并且优选钉仓装置的外周长度)与钉线长度之比在大约0.95到1.02的范围内而得到。
在与本发明的阶梯形双波浪形状或者阶梯形鱼嘴形状不同的钉合器几何形状中，实验已经获得钉线长度与砧座(优选整个钉紧固组件)的外周长度之间的如下比率选择：
-在其中由闭合钉排限定的线具有离开垂直于钉紧固组件的纵向轴线的中间平面的阶梯形状的圆形钉合器中，钉线具有比砧座或者钉紧固组件的外周长更大的长度，并且砧座或者钉紧固组件的外周长与所述钉线长度的比率优选在0.89和0.97之间。
-在其中由闭合钉排限定的线具有离开垂直于钉紧固组件的纵向轴线的中间平面的波浪形状的圆形钉合器中，钉线具有比砧座或者钉紧固组件的外周长更大的长度，并且砧座或者钉紧固组件的外周长与所述钉线长度的比率优选在0.95和1.02之间。
-在其中由闭合钉排限定的线具有离开相对于钉紧固组件的纵向轴线倾斜的平面的椭圆形形状的圆形钉合器中，钉线具有比砧座或者钉紧固组件的外周长更大的长度，并且砧座或者钉紧固组件的外周长与所述钉线长度的比率优选在0.93和0.99之间。
在该实施方式中，刀的切割边缘具有与由阶梯或偏移局部几何形状形成的两波峰-两波谷的几何形状大致相同的几何形状，如上面与组织夹紧表面14、20有关的描述那样。刀的形状基本上符合内侧闭合钉排沿着其设置的线的形状，但具有略小的直径，以便沿着相对于内侧钉排的内周切割。
图3显示了适用于前面已经描述的钉合器械的钉驱动装置的远侧部分27。在该实施方式中，该远侧部分27是一体模制成形的套筒结构。该远侧部分27包括在远侧终止于基座29的致动器轴28，该基座29通过肋30加强。当钉紧固组件4安装在该致动器轴28的远端上时致动器轴28的近端与钉合器械1的轴2内部的致动杆(未显示)连接。当器械被“击发”时，即当定位在器械的手柄处的致动扳机运行时，致动杆沿着远侧方向运动，从而也沿着远侧方向推动套筒结构。
钉驱动装置27包括用于每个钉的推动器，该推动器沿着远侧方向突出并与钉紧固组件4的纵向轴线X平行。推动器被设置成两排，特别是，外排推动器31用于闭合的外侧钉排17，内排推动器32用于闭合的内侧钉排18。在钉紧固组件4的组装状态下，外排推动器31在引导槽15中被引导，而内排推动器32在引导槽16中被引导。如图3中所示，所有的推动器31、32彼此平行并与纵向轴线X平行，并且它们的长度使得它们的远端侧、即推动表面33(抵接在相应钉的冠部(crown)上)遵循上面参照远端面14描述的两波峰-两波谷的波浪形状。推动表面33基本上垂直于纵向轴线X，从而一起限定了在上述波浪形状周围“振荡”的阶梯形或者偏移几何形状。
钉合器械1的操作在图6A、6B、6C和6D中示出。图6A显示了其中砧座9已经被***到远侧腔34中并且钉紧固组件4的近侧部分设置在吻合中待与远侧腔34连接的近侧腔35的内部的状态。两个腔34、35都分别与砧座轴19以及套管针轴7连接。如同图6B中看到的那样，砧座9接近套管针轴7，直到套管针轴端10与砧座轴19接合。砧座与仓装置的以一定角度对准例如通过在砧座19中形成的凹槽以及在套管针轴7中形成的相应齿来保证。在将砧座与套管针轴7连接之后，调节旋钮6的旋转使砧座9和仓装置8靠近，从而使远侧腔34和近侧腔35被朝向彼此拉动并将它们夹紧在仓装置的端面14与砧座9的钉成形表面20之间。在该阶段，组织沿着由闭合钉排形成的线遵循钉合器械的组织夹紧表面14、20的形状。
当器械被击发时，钉几乎同时从仓装置的端面被排出，刺穿组织并在砧座的钉成形表面上被扭弯。此后紧接着，圆形刀的切割边缘切割保持在钉的圆周范围内的组织。击发后，砧座9与仓装置8之间的间隙被增加到足以释放吻合接缝的程度。由于仓装置的端面14和砧座的钉成形表面20的组合波浪形和阶梯形几何形状，钉合接缝具有比相应的通过相同外径的已知圆形钉合器得到的钉合接缝更长的长度并且同时具有减小的纵向延伸部分。因此，器械的回缩更容易，组织损伤和术后并发症的风险被降低。
虽然已经详细描述了本发明的优选实施方式，但申请人并不是想要将权利要求书的范围限制为所述特定实施方式，而是覆盖落入本发明范围内的所有修改和替代构造。
Claims (21)
1、一种外科钉合器械(1)，包括：
具有主体部分(2)和手柄(3)的机架，
位于所述器械的远侧区域中的钉紧固组件(4)，该钉紧固组件(4)包括仓装置(8)和砧座(9)，该仓装置(8)包括至少一个闭合钉排(17、18)并限定有波浪形的远端面(14)，该砧座(9)限定有与所述远端面(14)大致匹配的波浪形的近侧钉成形表面(20)，并且砧座(9)能够相对于所述仓装置(8)运动并能够与所述仓装置(8)协同动作以便使从所述仓装置(8)排出的钉的端部成形，
能够使所述砧座(9)相对于所述仓装置(8)运动的运动装置，
能够朝着所述砧座(9)驱动钉离开所述仓装置(8)的钉驱动装置(27)，
所述外科钉合器械的特征在于：
所述远端面(14)和所述钉成形表面(20)具有总体波浪形状，该波浪形状包括两个相对的波峰(21)和与相邻波峰(21)间隔大约90°角的两个相对的波谷(22)，并且所述两波峰-两波谷的波浪形状由所述远端面(14)和所述钉成形表面(20)的阶梯构型形成。
2、根据权利要求1所述的外科钉合器械(1)，其特征在于，所述远端面(14)和所述钉成形表面(20)包括一系列接触面(23；25)和竖立面(24；26)，并且所述接触面(23；25)与所述钉紧固组件(4)的纵向轴线(X)基本上垂直，并且钉引导槽(15、16)的出口以及钉成形槽在接触面(23、25)中形成。
3、根据权利要求1或2所述的外科钉合器械(1)，其特征在于，所有钉引导槽(15、16)和容纳在所述钉引导槽中的钉与所述钉驱动装置(27)的钉驱动方向平行，所述钉驱动装置(27)的钉驱动方向与所述钉紧固组件(4)的纵向轴线(X)一致。
4、根据前述任一项权利要求所述的外科钉合器械(1)，其特征在于，钉在所述仓装置(8)中沿着波浪线布置，所述波浪线包括两个相对的波峰和与相邻波峰间隔大约90°角的两个相对的波谷，并且钉沿着其布置的线与所述仓装置(8)的所述远端面(14)基本上平行。
5、根据前述任一项权利要求所述的外科钉合器械(1)，其特征在于，所述远端面(14)和钉成形表面(20)以及钉线在垂直于所述钉紧固组件(4)的纵向轴线(X)的平面上的投影为圆形。
6、根据前述任一项权利要求所述的外科钉合器械(1)，其特征在于，所述远端面(14)和钉成形表面(20)的所述波峰(21)和波谷(22)之间的最大轴向距离小于20mm，优选小于10mm。
7、根据前述任一项权利要求所述的外科钉合器械(1)，其特征在于，所述砧座(9)的外周小于或者大致等于沿着所述钉线的所述远端面(14)的总长度。
8、根据前述任一项权利要求所述的外科钉合器械(1)，其特征在于，所述砧座(9)的外周长度与所述钉线长度的比率处于从0.95到1.02的范围内。
9、根据前述任一项权利要求所述的外科钉合器械(1)，其特征在于，两个相对的波峰(21)具有距垂直于所述纵向轴线(X)的平面相同的轴向距离，并且两个相对的波谷(22)具有距垂直于所述纵向轴线(X)的平面相同的轴向距离。
10、根据前述任一项权利要求所述的外科钉合器械(1)，其特征在于，所述远端面(14)和所述钉成形表面(20)的所述两波峰-两波谷的阶梯形状相对于由所述钉紧固组件(4)的纵向轴线(X)和所述两个波谷(22)点限定的第一平面对称，并相对于由所述纵向轴线(X)和所述两个波峰(21)点限定的与所述第一平面垂直的第二平面对称。
11、根据前述任一项权利要求所述的外科钉合器械(1)，其特征在于，所述钉驱动装置(27)包括多个推动器(31、32)，所述推动器(31、32)能够直接接触钉并将钉向远侧推靠到所述砧座(9)上，其中所有的推动器(31、32)彼此平行并与所述钉紧固组件(4)的纵向轴线(X)平行。
12、根据前述任一项权利要求所述的外科钉合器械(1)，其特征在于，所述推动器(31、32)的长度使得它们的远侧推动表面(33)遵循所述远端面(14)的所述两波峰-两波谷的波浪形状。
13、根据权利要求11或12所述的外科钉合器械(1)，其特征在于，所述推动表面(33)基本上垂直于所述纵向轴线(X)
14、根据权利要求11至13中任一项所述的外科钉合器械(1)，其特征在于，所有推动器(31、32)以单件结构(27)一体形成。
15、根据前述任一项权利要求所述的外科钉合器械(1)，包括：
具有闭合的切割边缘的刀，其中所述刀设置在所述仓装置(8)中并被定位成使得所述切割边缘的外侧上存在至少一个闭合钉排(18)，
能够使所述刀向远侧朝着所述砧座(9)运动的刀致动装置(27)，
其中限定所述刀的切割边缘的线具有总体波浪形状，该波浪形状包括两个相对波峰和与相邻波峰间隔大约90°角的两个相对的波谷，并且其中所述两波峰-两波谷的波浪形状通过所述切割边缘的局部阶梯构型获得。
16、根据前述任一项权利要求所述的外科钉合器械(1)，其特征在于，所述仓装置(8)容纳至少两个闭合的钉排(17、18)，相邻的钉排(17、18)的钉相对于彼此交错，并且限定两个钉排的出口的所述阶梯的接触面(23)相对于彼此交错。
17、根据前述任一项权利要求所述的外科钉合器械(1)，其特征在于，所述钉紧固组件(4)能够拆卸地安装在所述主体部分(2)的远端区域中。
18、根据前述任一项权利要求所述的外科钉合器械(1)，其特征在于，所述仓装置(8)包括容纳钉的可拆卸的仓。
19、一种具有如权利要求1到18中任一项所述的钉紧固组件(4)的特征的钉紧固组件。
20、一种具有如权利要求1到18中任一项所述的仓装置(8)的特征的仓装置。
21、一种具有如权利要求15所述的刀的特征的刀。
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP06116804.3 | 2006-07-07 | ||
| EP06116804A EP1875870B1 (en) | 2006-07-07 | 2006-07-07 | A surgical stapling instrument. |
| PCT/EP2007/056055 WO2008003582A2 (en) | 2006-07-07 | 2007-06-19 | A surgical stapling instrument |
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| Publication Number | Publication Date |
|---|---|
| CN101484078A true CN101484078A (zh) | 2009-07-15 |
| CN101484078B CN101484078B (zh) | 2011-09-07 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN2007800255526A Expired - Fee Related CN101484078B (zh) | 2006-07-07 | 2007-06-19 | 外科钉合器械 |
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| Country | Link |
|---|---|
| US (3) | US8413870B2 (zh) |
| EP (1) | EP1875870B1 (zh) |
| JP (1) | JP5410276B2 (zh) |
| CN (1) | CN101484078B (zh) |
| AT (1) | ATE450208T1 (zh) |
| BR (1) | BRPI0713925A2 (zh) |
| DE (1) | DE602006010845D1 (zh) |
| WO (1) | WO2008003582A2 (zh) |
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2012
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2015
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| CN104135952A (zh) * | 2012-02-14 | 2014-11-05 | 伊西康内外科公司 | 线性缝合器 |
| CN104349728A (zh) * | 2012-03-28 | 2015-02-11 | 伊西康内外科公司 | 用于圆形外科缝合器的组织厚度补偿件 |
| CN104349728B (zh) * | 2012-03-28 | 2017-01-18 | 伊西康内外科公司 | 用于圆形外科缝合器的组织厚度补偿件 |
| CN102835986B (zh) * | 2012-09-25 | 2014-10-22 | 夏时苍 | 一次性医用消化管多面立体切割吻合器 |
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| CN109414267B (zh) * | 2016-04-01 | 2021-07-09 | 伊西康有限责任公司 | 包括钳口闭合闭锁件的外科缝合*** |
| CN109963517B (zh) * | 2016-11-14 | 2022-07-01 | 爱惜康有限责任公司 | 用于圆形外科缝合器的无创伤缝合头部特征部 |
| CN110177510B (zh) * | 2016-11-14 | 2022-07-05 | 爱惜康有限责任公司 | 具有角度非对称平台特征部的圆形外科缝合器 |
| CN109963517A (zh) * | 2016-11-14 | 2019-07-02 | 爱惜康有限责任公司 | 用于圆形外科缝合器的无创伤缝合头部特征部 |
| CN110177510A (zh) * | 2016-11-14 | 2019-08-27 | 爱惜康有限责任公司 | 具有角度非对称平台特征部的圆形外科缝合器 |
| CN110381852A (zh) * | 2017-03-09 | 2019-10-25 | 柯惠有限合伙公司 | 用于圆形钉合器设备的末端执行器组合件 |
| CN110381852B (zh) * | 2017-03-09 | 2022-12-27 | 柯惠有限合伙公司 | 用于圆形钉合器设备的末端执行器组合件 |
| CN109419543A (zh) * | 2017-08-31 | 2019-03-05 | 江苏风和医疗器材股份有限公司 | 一种端部执行器及其外科器械 |
Also Published As
| Publication number | Publication date |
|---|---|
| JP2009542269A (ja) | 2009-12-03 |
| EP1875870B1 (en) | 2009-12-02 |
| US8413870B2 (en) | 2013-04-09 |
| JP5410276B2 (ja) | 2014-02-05 |
| US20150230797A1 (en) | 2015-08-20 |
| ATE450208T1 (de) | 2009-12-15 |
| CN101484078B (zh) | 2011-09-07 |
| US10080565B2 (en) | 2018-09-25 |
| WO2008003582A2 (en) | 2008-01-10 |
| US20100108740A1 (en) | 2010-05-06 |
| WO2008003582A3 (en) | 2008-05-02 |
| EP1875870A1 (en) | 2008-01-09 |
| BRPI0713925A2 (pt) | 2012-11-27 |
| DE602006010845D1 (de) | 2010-01-14 |
| US20120193395A1 (en) | 2012-08-02 |
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