CN111743591B - 用于外科缝合器械的砧座组件 - Google Patents
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Abstract
本发明涉及用于外科缝合器械的砧座组件。一种用于与圆形缝合器械一起使用的砧座组件包括砧座中心杆和砧座头。所述砧座头包括砧座壳体、支承构件和至少一个保持器。所述支承构件被配置成用于从将所述砧座头保持在第一操作状态的初始纵向位置纵向移动到允许所述砧座头枢转地移动到第二倾斜状态的前进纵向位置。
Description
相关申请的交叉引用
本申请要求于2019年3月26日提交的美国临时专利申请序列号62/823,924的权益和优先权,其全部公开内容通过引用并入本文中。
技术领域
本发明总体上涉及一种外科缝合器械,并且更具体地,涉及一种用于与圆形缝合器械一起使用的砧座组件,所述圆形缝合器械具有在致动缝合器械时能够枢转或倾斜的砧座头,以便于相对于手术部位插入和/或抽出砧座组件。
背景技术
用于执行诸如吻合、痔疮切除术和粘膜切除术的外科手术的外科缝合器械是众所周知的。在环形吻合手术中,使用圆形缝合器械连接器官部分的两端。通常,这些圆形缝合器械包括手柄、具有缝钉保持部件的细长轴以及可安装到缝钉保持部件的砧座组件。所述砧座组件包括砧座中心杆和附接的砧座头,所述砧座头可相对于砧座中心杆枢转以便于相对于器官部分插入和取出砧座组件。在使用中,将器官部分的相对的组织端部边缘夹持在砧座头与缝钉保持部件之间。击发所述器械,驱动来自缝钉保持部件的环形阵列的缝钉穿过器官部分的组织端部边缘以抵靠砧座头变形。将缝钉保持部件内的环形刀推进以将缝钉内部的器官组织去除或移除,以清扫器官部分的内部管状通道。此后,可以使砧座头相对于砧座中心杆倾斜,以便于从附接的器官部分内抽出砧座组件。在共同转让的美国专利第9,750,503号中公开了一种用于执行组织的环形吻合的器械的实例,所述专利的全部内容通过引用并入本文中。
发明内容
本发明的一个方面涉及一种用于与圆形缝合器械一起使用的外科砧座组件,包括砧座中心杆和砧座头,所述砧座头可枢转地联接到砧座中心杆并可在第一操作状态和第二倾斜状态之间移动。所述砧座头包括限定中心纵向轴线的砧座壳体、设置在所述砧座壳体内的支承构件和邻近所述支承构件定位在所述砧座壳体中的保持器。所述支承构件被配置为用于相对于所述砧座壳体从将所述砧座头保持在所述第一操作状态的初始纵向位置纵向移动到允许所述砧座头枢转地移动到所述第二倾斜状态的前进纵向位置。所述支承构件包括具有多个力传递凸起的外板区段。保持器被配置为将支承构件保持在初始纵向位置。保持器包括外部保持器区段,所述外部保持器区段限定外部可变形区域,所述外部可变形区域大致与支承构件的力传递凸起纵向对齐。外部可变形区域被配置成由支承构件的力传递凸起接合,并且在向支承构件施加预定纵向力时至少部分地变形,以允许支承构件移动到前进纵向位置。
在实施例中,砧座壳体包括壳体壁,其中保持器至少部分地定位在壳体壁和支承构件之间。在一些实施例中,支承构件的力传递凸起相对于中心纵向轴线同轴地布置。在某些实施例中,保持器的外部可变形区域围绕所述中心纵向轴线同轴地布置。在实施例中,外部保持器区段包括界定于其中的至少两个凹槽,借此外部可变形区域至少部分地界定于所述两个凹槽之间。在一些实施例中,所述至少两个凹槽是环形的并且围绕中心纵向轴线同轴地布置。
在某些实施例中,保持器的外部可变形区域被配置为:在向支承构件施加预定纵向力时与支承构件的力传递凸起接合时,相对于外部保持器区段断裂。
在实施例中,保持器包括从外部可变形区域径向向内的内部可变形环。内部可变形环被配置成由所述支承构件接合,并且在向所述支承构件施加预定纵向力时至少部分地变形。在一些实施例中,内部可变形环被配置成在向支承构件施加预定纵向力时断裂。
在某些实施例中,切割环邻近支承构件定位。在实施例中,砧座头包括从壳体壁悬垂的砧座柱,其中保持器、支承构件和切割环围绕砧座柱同轴地安装。
本发明的另一方面是针对一种用于圆形缝合器械的端部执行器。端部执行器包括仓组件和可相对于仓组件安装的砧座组件。仓组件包括仓壳体和环形刀,所述环形刀经配置用于相对于仓壳体从未致动位置到致动位置的前进移动。砧座组件包括砧座中心杆和枢转地联接到砧座中心杆并可在第一操作状态与第二倾斜状态之间移动的砧座头。所述砧座头包括限定中心纵向轴线的砧座壳体、设置在所述砧座壳体内的支承构件和邻近所述支承构件定位在所述砧座壳体中的保持器。支承构件经配置用于相对于所述砧座壳体从将所述砧座头保持在所述第一操作状态的初始纵向位置纵向移动到在环形刀朝向致动位置前进时允许所述砧座头枢转地移动到所述第二倾斜状态的前进纵向位置。所述支承构件包括外板区段,所述外板区段具有相对于所述中心纵向轴线同轴布置的多个力传递凸起。保持器被配置为将支承构件保持在初始纵向位置。保持器包括外部保持器区段,所述外部保持器区段限定环形可变形区域,所述环形可变形区域相对于中心纵向轴线同轴地布置并且大致与支承构件的力传递凸起纵向对齐。环形可变形区域被配置成由支承构件的力传递凸起接合,并且在环形刀朝向致动位置前进移动时至少部分地变形,以允许支承构件移动到前进纵向位置。
在实施例中,保持器包括内部可变形环,所述内部可变形环在环形可变形区域的径向内部,并且配置成由支承构件接合并且在环形刀朝向致动位置前进移动时至少部分地变形。在一些实施例中,环形可变形区和内部可变形环各自被配置成在环形刀朝向致动位置前进移动时断裂。在某些实施例中,支承构件包括一对径向相对的指状物,所述指状物配置成在所述支承构件的初始纵向位置与砧座中心杆接合,以将砧座头保持在第一操作状态,并且所述指状物配置成在移动到所述前进纵向位置时释放所述砧座中心杆,以允许砧座头枢转移动到第二倾斜状态。
所公开的砧座组件的支承构件和保持器的部件协作,以确保在支承构件受到预定力(例如,前进的环形刀)时实现保持器的变形和/或断裂,以允许砧座杆的完全释放和砧座头到倾斜状态的随后的枢转移动。
本发明的另一方面是针对一种用于与圆形缝合器械一起使用的外科砧座组件,包括砧座中心杆和砧座头。砧座头枢转地联接到砧座中心杆并可在第一操作状态和第二倾斜状态之间移动。砧座头包括砧座壳体、支承构件、内部保持器和外部保持器。砧座壳体限定了中心纵向轴线和由远侧壁表面限定的空腔。支承构件设置在砧座壳体内并且具有内周表面和外周表面。支承构件可从初始纵向位置移动到前进纵向位置,在所述初始纵向位置,支承构件将砧座头保持在第一操作状态,在所述前进纵向位置,支承构件允许砧座头枢转移动到第二倾斜状态。内部保持器邻近支承构件定位在砧座壳体中以接合所述支承构件的内周表面,从而将所述支承构件保持在初始纵向位置。内部保持器包括分离区,所述分离区在支承构件上施加预定远侧力时是易碎的,以允许所述支承构件移动到前进纵向位置。外部保持器邻近支承构件定位在砧座壳体中以接合所述支承构件的外周表面,从而将所述支承构件保持在初始纵向位置。外部保持器包括易碎部分,所述易碎部分在支承构件上施加预定远侧力时是易碎的,以允许所述支承构件移动到前进纵向位置。
在实施例中,内部保持器包括环形本体,所述环形本体具有定位成与壳体的远侧壁表面成邻接关系的远侧部分。
在一些实施例中,内部保持器包括支座构件,所述支座构件支撑支承构件的内周表面,其中支座构件通过包括分离区的连接区段联接到环形本体。
在某些实施例中,支座构件包括围绕环形本体间隔开的多个支座构件。
在实施例中,外部保持器包括本体,所述本体具有近侧台阶和远侧台阶,其中远侧台阶包括邻接表面,所述邻接表面定位成邻接限定空腔的远侧壁表面,并且所述近侧台阶包括支撑表面,所述支撑表面定位成支撑所述支承构件的外周表面。
在一些实施例中,外部台阶包括易碎部分。
在某些实施例中,切割环支撑在支承构件的远侧面上。
本发明的另一方面是针对一种用于与圆形缝合器械一起使用的外科砧座组件,包括砧座中心杆和砧座头。砧座头枢转地联接到砧座中心杆并可在第一操作状态和第二倾斜状态之间移动。砧座头包括砧座壳体、支承构件、切割环、支承垫圈、顺应垫圈和保持器。砧座壳体限定了中心纵向轴线和由远侧壁表面限定的空腔。支承构件设置在砧座壳体内并且包括内周表面和外周表面。支承构件可从初始纵向位置移动到前进纵向位置,在所述初始纵向位置,支承构件将砧座头保持在第一操作状态,在所述前进纵向位置,支承构件允许砧座头枢转移动到第二倾斜状态。顺应垫圈支撑在支承构件的远侧面上。支承垫圈支撑在顺应垫圈的远侧面上并且由金属形成。切割环支撑在支承垫圈的远侧面上。保持器邻近支承构件定位在砧座壳体中,并且定位成接合支承构件以将所述支承构件保持在初始纵向位置。保持器在支承构件上施加预定远侧力时是可变形的或易碎的,以允许所述支承构件移动到前进纵向位置,其中支承垫圈配置成在支撑垫圈上施加预定力时变形为顺应垫圈。
在一些实施例中,支承垫圈具有约.0254mm至约.762mm的厚度,其中约.254mm是最优选的,并且包括其间的任何子范围。
在一些实施例中,顺应垫圈由橡胶形成。
在某些实施例中,支承垫圈由不锈钢形成。
在实施例中,保持器定位成接合保持器的内周表面。
将根据以下描述理解本发明的其它特征。
附图说明
下面参考附图描述用于与外科圆形缝合器械一起使用的所公开的砧座组件的各种实施例,其中:
图1是根据本发明的结合具有砧座组件的示例性实施例的端部执行器的外科圆形缝合器械的透视图;
图2是图1中所示的缝合器械的砧座组件的透视图;
图3是图2中所示的砧座组件的分解透视图;
图4是沿着图1的剖面线4-4截取的端部执行器的剖视图;
图5是图3中所示的砧座组件的支承构件的透视图;
图6是沿图2的剖面线6-6截取的图3中所示的砧座组件的砧座头的剖视图;
图7是图3中所示的砧座组件的保持器的透视图;
图8是沿图7的剖面线8-8截取的局部截面透视图;
图9是类似于图4的视图的端部执行器的剖视图,示出了在致动端部执行器的环形刀以使砧座组件的保持器至少部分地变形时处于前进纵向位置的支承构件;
图10是类似于图6的视图的剖视图,示出了处于前进纵向位置的支承构件,其中砧座杆从支承构件的指状物释放以允许砧座头的枢转移动;
图11是图10中所示的砧座组件的侧剖视图,示出了处于第二倾斜状态的砧座头;
图12是图1中所示的缝合器械的砧座组件的另一示范性实施例的透视图;
图13是图12中所示的砧座组件的分解透视图;
图14是图13中所示的砧座组件的外部易碎环的侧面透视图;
图15是沿图16的剖面线17-17截取的剖视图;
图16是现有技术中砧座组件的砧座头的侧面透视图;
图17是图13中所示的砧座组件的砧座头的侧面透视图;
图18是沿图12的剖面线18-18截取的剖视图,其中支承环在砧座头内处于缩回位置;
图19是沿图12的剖面线18-18截取的剖视图,其中支承环在砧座头内处于前进位置;
图20是图1中所示缝合器械的砧座组件的另一示范性实施例的分解透视图;
图21是通过图20中所示的砧座组件截取的侧剖视图,其中支承环在砧座组件的砧座头内处于缩回位置;
图22是通过图20中所示的砧座组件截取的侧剖视图,其中支承环在砧座组件的砧座头内处于前进位置;和
图23是图22中所示的细节的指示区域的放大视图。
具体实施方式
现在参考附图详细描述本发明的实施例,在附图中,相同的附图标记在若干视图的每一个中表示相同或相应的元件。如本文中所使用,术语“临床医生”指的是医生、护士或任何其它护理提供者,并且可以包括辅助人员。贯穿本说明书,术语“近侧”指的是最接近临床医生的器械或其部件的部分,而术语“远侧”指的是离临床医生最远的器械或其部件的部分。此外,术语“约”是指确定的参数的90%和110%。
示范性外科缝合器械包括手柄组件、从手柄组件延伸的细长本体或适配器以及可联接到适配器的端部执行器。端部执行器包括具有环形阵列的缝钉和环形刀的仓组件,以及砧座组件。砧座组件包括可释放地联接到仓组件的砧座中心杆和枢转地联接到砧座中心杆的砧座头。砧座头包括容纳支承构件的砧座壳体和设置在支承构件远侧的可变形或易碎保持器。切割环可以设置在支承构件的近侧。保持器使支承构件与砧座中心杆保持操作接合,从而在器械击发之前将砧座头固定在与仓组件相对的操作状态。在使用中,待连接的管状器官部分的组织端部边缘分别围绕砧座头和仓组件定位。砧座头和仓组件接近,并且器械被致动,导致缝钉的顶出和环形刀穿过由砧座头的切割环和支承构件支撑的组织端部边缘的前进移动。环形刀的前进使支承构件也相对于砧座壳体前进并且接合保持器以使保持器变形和/或断裂。保持器的这种变形将支承构件从其与砧座中心杆的操作接合中释放,从而允许砧座头移动到倾斜或枢转状态。保持器和支承构件包括多个协作结构,所述多个协作结构捕获并直接传递由环形刀施加的力,以提供保持器的精确变形和/或断裂,从而确保支承构件完全释放砧座杆,以允许砧座头的不受阻碍的枢转移动。
参考图1-2,结合有本发明的端部执行器和砧座组件的圆形缝合器械通常被示为圆形缝合器械10。圆形缝合器械10包括手柄12、从手柄12延伸的细长本体或适配器14,以及联接到适配器14的端部执行器16。手柄12可以是电动的并且包括马达和相关的齿轮和联动装置以控制缝合器械10的操作。手柄12结合有把手18和多个致动按钮20,致动按钮20可被致动以控制缝合器械10的各种功能,包括例如端部执行器16的接近和缝钉的击发。把手18可以支撑为手柄12供电的电池组(未示出)。还可以设想,手柄12可被手动供电。手动供电手柄组件的实例在共同转让的美国专利No.8,360,295;8,424,535;和8,789,737中描述,将所述专利各自的全部内容通过引用并入本文中。
在实施例中,适配器14可释放地联接到手柄12,并且包括多个驱动机构(未示出),所述驱动机构响应于致动按钮20的致动将来自手柄12的动力传递到端部执行器16,以实现端部执行器16的操作,即,接近和击发。共同转让的美国专利No.8,806,973;9,055,943;9,247,940;以及9,629,633公开了适于与缝合器械10一起使用的动力手柄和适配器的示范性实施例,并且所述专利各自的全部内容通过引用并入本文中。可替代地,细长本体或适配器14可以不可移除地固定到手柄12上。
端部执行器16包括仓组件22和可相对于仓组件22联接的砧座组件24。通常,仓组件22结合有仓壳体26、位于仓壳体26内的一排或多排环形缝钉(未示出)、用于推进缝钉穿过管状器官部分的组织端部边缘的缝钉推进器(未示出)和缝钉内部的环形刀(图1中未示出)以在部署缝钉期间或之后推进环形刀时切断和移除管状器官部分内的过量器官组织。
现在参考图2-4,将描述端部执行器16的砧座组件24。砧座组件24与共同转让的美国专利No.8,540,132(“132专利”)中公开的砧座组件共享一些共同特征,所述专利的全部内容通过引用并入本文中。砧座组件24包括砧座中心杆28和枢转地安装到砧座中心杆28的砧座头30。砧座中心杆28包括一对具有远侧搁板34的间隔开的臂32。砧座头30适于相对于砧座中心杆28在与仓组件22(如图1所示)相对的第一操作状态与第二枢转或倾斜状态之间枢转,并且通常可经由弹簧偏置的柱塞机构(未示出)偏置到第二倾斜状态。砧座头30包括带有内部砧座柱38的砧座壳体36,所述内部砧座柱至少部分地容纳在砧座中心杆28的间隔开的臂32内。枢轴销40延伸穿过间隔开的臂32和砧座柱38的相应横向孔42、44,以便将砧座头30枢转地联接到砧座中心杆28上。
参考图3-4,砧座组件24的砧座壳体36限定了砧座柱38沿其延伸的中心纵向轴线“k”。砧座壳体36包括远侧壳体壁46和内部壳体凹部50,所述远侧壳体壁限定支撑砧座柱38的内壁表面48。砧座柱38包括至少一个键槽52,并且在实施例中包括一对径向相对的键槽52。砧座壳体36包括外接内部壳体凹部50的外部组织接触表面54。外部组织接触表面54支撑管状器官部分的组织端部边缘,并结合有多个缝钉变形凹坑56,以容纳从仓组件22的仓壳体26顶出的缝钉并使之变形。
砧座头30从近侧到远侧包括切割环58、支承构件60和易碎或可变形保持器62,每个部件皆设置在砧座壳体36的内部壳体凹部50内并且围绕砧座柱38同轴地布置(图3)。切割环58包括盘状环形本体64,所述环形本体限定用于容纳砧座柱38的中心孔66。切割环58在缝合器械10的击发期间至少部分地被环形刀穿透,使得覆盖在切割环58上的组织端部边缘被环形刀切断,以产生穿过吻合的管状器官部分的通道。在实施例中,切割环58通过模制工艺(例如,注塑模制工艺)形成,且可由具有硬度的材料制成,所述硬度允许环形刀完全刺穿环形本体64且抵靠支承构件60从底部伸出。合适的材料包括聚丙烯或聚酯。也可以考虑其它材料。
支承构件60将参考图3-6进行讨论。支承构件60配置成用于在环形刀68(图4)在仓壳体26内朝向其致动位置移动时相对于砧座壳体36从初始纵向位置纵向移动到前进纵向位置。支承构件60包括外板区段70,所述外板区段限定中心孔72,所述中心孔的尺寸设置为围绕砧座壳体36的砧座柱38定位。支承构件60包括从外板区段70径向向内延伸并位于中心孔72内的一对径向相对的指状物74。如图6中最佳地示出,指状物74至少部分地容纳在砧座柱38的径向相对的键槽52内,以相对于砧座壳体36对齐和/或支撑支承构件60。指状物74还与砧座中心杆28的间隔开的臂32的远侧搁板34接合,以防止砧座头30绕枢轴销40枢转移动,并将砧座头30保持在与仓组件22相对的第一操作状态。
如图3中最佳地示出,支承构件60的外板区段70的近侧包括外接中心孔72的近侧凸起凸缘76,所述凸缘容纳在切割环58的中心孔66内。支承构件60的近侧凸起凸缘76可以压配合在切割环58的中心孔66内,以将这些部件彼此固定。可替代地,支承构件60和切割环58可使用接合剂、粘合剂、点焊等联接。在实施例中,支承构件60和切割环58彼此不固定。
参考图4-6,支承构件60的远侧包括:远侧凸起凸缘78,其外接中心孔72;以及多个力传递凸起80,其位于所述远侧凸起凸缘78的径向外侧,并从外板区段70沿纵向延伸。远侧凸起凸缘78可限定邻近中心孔72的环形凹面82。力传递凸起80可围绕砧座壳体36的中心纵向轴线“k”同轴地定向,以限定所示的环形或环状配置,并且可相对于彼此等距离地间隔开。力传递凸起80的形状可大致为盒状(例如,矩形盒),但是也可以考虑其它形状和尺寸。支承构件60可以由诸如金属的硬质材料形成,但是也可以想到其它构造材料。
将参考图7-图8,结合图4来讨论保持器62。保持器62在支承构件60与砧座壳体36的内壁表面48之间围绕砧座柱38同轴设置。保持器62限定外周壁84、从外周壁84径向向内定位的外部保持器区段86、相对于外部保持器区段86凹入的中间保持器区段88和从中间保持器区段88向内的内部保持器区段90。内部保持器区段90限定用于容纳砧座柱38的中心孔92。外部保持器区段86具有限定在其中的第一和第二凹槽94、96,其相对于中心纵向轴线“k”同轴地布置。第一和第二凹槽94、96径向隔开以在其间限定可变形区域98。可变形区域98与支承构件60的力传递凸起80大致纵向对齐,并且在环形刀68通过与力传递凸起80接合而被致动时沿着第一和第二凹槽94、96至少部分地变形或断裂。
内部保持器区段90包括多个(例如四个)突片100,所述突片沿近侧方向悬垂,用于容纳在支承构件60的中心孔72内。突片100使保持器62相对于支承构件60稳定。内部可变形环102联接到突片100,并相对于中心纵向轴线“k”以同轴关系布置。在实施例中,内部可变形环102经由在相应突片100与内部可变形环102之间延伸的连接区段104联接到每个突片100。连接区段104限定分离区,在环形刀68致动时,内部可变形环102沿着所述分离区相对于突片100变形或断裂。内部可变形环102相对于中间保持器区段88的表面间隔开,并可抵靠在支承构件60的凹面82上。保持器62可由合适的弹性材料或金属材料整体形成。
图4示出了仓组件22的环形刀68致动之前的砧座组件24的部件的关系,其中支承构件60处于初始纵向位置。在初始纵向位置,保持器62的外周壁84和中间保持器区段88与砧座壳体36的内壁表面48接合,并且保持器62的外部保持器区段86和内部可变形环102与支承构件60接合。这种布置将支承构件60保持在砧座壳体36内的缩回位置,所述缩回位置对应于支承构件60的初始纵向位置和砧座头30的第一操作状态。
现在将讨论端部执行器16的使用。待连接的管状器官部分的组织端部边缘分别围绕砧座头30和仓组件22的仓壳体26放置,并通过荷包缝合或任何其它常规方法固定。砧座头30和仓组件22接近。接着击发缝合器械10以将缝钉从仓组件22中顶出,用于穿过管状器官部分的组织端部边缘并抵靠砧座壳体3的缝钉变形凹坑56变形。环形刀68被致动以使环形刀68从图4的在仓组件22内的未致动位置前进到图9的致动位置,所述环形刀延伸穿过组织端部边缘并且至少部分地或完全地穿过切割环58。当环形刀68前进时,支承构件60朝向前进纵向位置前进。这种移动导致:1)支承构件60的力传递凸起80在限定于保持器62的同轴的第一凹槽94和第二凹槽96之间的可变形区域98上施加力,所述力足以使保持器62的外部可变形区域98沿着凹槽94、96变形和/或碎裂;和2)支承构件60的远侧凸起凸缘78沿着连接区段104使内部可变形环102变形和/或破碎。如图10最佳地示出,保持器62的变形也允许支承构件60和(可能地)切割环58沿着砧座柱38前进,其中支承构件60的指状物74横穿砧座柱38的键槽52。此移动将指状物74从与砧座中心杆28的间隔开的臂32的远侧搁板34的接合中释放。因此,砧座头30可以从砧座头30与仓组件22相对的第一操作状态(图1)枢转到图10中所示的第二倾斜状态。弹簧偏置的柱塞机构可与砧座中心杆28相关联,以偏压砧座头30并导致绕枢轴销40的枢转移动,从而呈现图10中所示的第二倾斜状态。柱塞机构的细节可参考美国专利No.8,540,132确定。
支承构件60将由前进的环形刀68施加的力均匀地传递跨过保持器62,以使保持器62充分变形或断裂,从而实现支承构件60在砧座壳体36内的前进移动和砧座中心杆28的释放。具体地,力传递凸起80和支承构件60的远侧凸起凸缘78以及保持器62的相应的可变形区域98和内部可变形环102的环形对齐布置,确保由前进的环形刀68产生的力被捕获并直接传送,以引起保持器62的完全变形和/或断裂,从而允许砧座头30向第二倾斜状态的期望枢转移动。
图12和13示出了砧座组件的另一示范性实施例,其通常示为砧座组件124。砧座组件124还与'132专利中公开的砧座组件共享一些共同特征,并且包括砧座中心杆128和枢转地安装到砧座中心杆128的砧座头130。砧座中心杆128包括一对具有远侧搁板134的间隔开的臂132。砧座头130适于相对于砧座中心杆128在与仓组件22相对的第一操作状态(图1)与第二枢转或倾斜状态(图11)之间枢转,并且通常可经由弹簧偏置的柱塞机构(未示出)偏置到第二倾斜状态。砧座头130包括具有内部砧座柱138的砧座壳体136,所述砧座柱至少部分地容纳在砧座中心杆128的间隔开的臂132(图13)内。枢轴销140(图18)延伸穿过间隔开的臂132和砧座柱138的相应横向孔142、144(图13),以将砧座头130枢转地联接到砧座中心杆128。
砧座壳体136限定了砧座柱138沿其延伸的中心纵向轴线“k”(图13)。砧座壳体136包括限定远侧壁表面148的内部壳体壁146,所述远侧壁表面支撑砧座柱138并限定内部壳体凹部150。在实施例中,砧座柱138包括至少一个键槽152,并且在一些实施例中,包括径向相对的键槽152。砧座壳体136包括外接内部壳体凹部150的外部组织接触表面154。外部组织接触表面154支撑管状器官部分的组织端部边缘,并且限定多个缝钉变形凹坑156,所述缝钉变形凹坑定位成容纳从仓组件22的仓壳体26顶出的缝钉并使之变形。
砧座头130从近侧到远侧包括切割环158、支承构件160、外部易碎或可变形保持器162和内部易碎或可变形保持器163。每个保持器162、163设置在砧座壳体136的内部壳体凹部150内,并围绕砧座柱138同轴地布置(图3)。切割环158包括盘状环形本体164,所述环形本体限定用于容纳砧座柱138的中心孔166。切割环158在缝合器械10(图1)的击发期间至少部分地被环形刀68穿透,使得覆盖切割环158的组织端部边缘被环形刀68切断,以产生穿过吻合的管状器官部分的通道。在实施例中,切割环158通过模制工艺(例如,注塑模制工艺)形成,且可由具有硬度的材料制成,所述硬度允许环形刀68完全刺穿环形本体164并抵靠支承构件160从底部伸出。用于形成切割环158的合适材料包括聚丙烯和聚酯。也可以考虑其它材料。
支承构件160配置成用于在环形刀68(图4)在砧座壳体136的内部壳体凹部150内朝向其致动位置移动时相对于砧座壳体136从初始纵向位置纵向移动到前进纵向位置。支承构件160包括外板区段170,所述外板区段限定中心孔172,所述中心孔的尺寸设置为围绕砧座壳体136的砧座柱138定位。支承构件160包括从外板区段170径向向内延伸到中心孔172中的一对径向相对的指状物174。指状物174至少部分地容纳在砧座柱138的径向相对的键槽152内,以在支承构件160在其初始纵向位置与其推进纵向位置之间移动期间相对于砧座壳体136对齐和/或引导支承构件160。指状物174还与砧座中心杆128的间隔开的臂132的远侧搁板134(图13)接合,以防止砧座头130绕枢轴销140枢转移动,并在缝合器械10(图1)击发之前将砧座头130保持在与仓组件22相对的第一操作状态。
支承构件160的外板区段170的近侧包括外接中心孔172的近侧凸起凸缘176,所述凸缘容纳在切割环158的中心孔166内。支承构件160的近侧凸起凸缘176可以压配合在切割环158的中心孔166内,以将这些部件彼此固定。在实施例中,近侧凸起凸缘176包括唇缘178(图18),当切割环联接到支承构件160时,所述唇缘悬于切割环158的内圆周之上。可替代地,或除此之外,支承构件160和切割环158可使用点焊接工艺等通过接合剂、粘合剂联接在一起。在实施例中,支承构件160由诸如金属(例如不锈钢)的刚性材料形成。
图13-15示出了外部易碎或可变形保持器162。保持器162包括台阶式本体180,所述台阶式本体包括近侧台阶182和远侧台阶184。远侧台阶184位于近侧台阶的径向内侧,并限定了容纳砧座柱138的中心孔186。远侧台阶184限定邻接砧座壳体136的远侧壁表面148(图19)的邻接表面184a(图15)。近侧台阶182限定支撑表面182a(图15)并包括易碎或可变形部分190。支撑表面182a支撑支承板160的外板区段170的外圆周,并且易碎或可变形部分190位于邻接表面184a与支撑表面182a之间。易碎或可变形部分190配置成当在远侧方向上在支承构件160上施加力时破裂或变形,如以下进一步详细描述的。在实施例中,易碎部分190可以包括环形凹槽192(图15)和/或一系列切口194。
内部易碎或可变形保持器163在图13中示出,并且包括环形本体163a,所述环形本体限定了中心孔198并且包括多个(例如,四个)突片200,所述突片沿近侧方向延伸进入和/或穿过支承构件160的中心孔172。本体163a包括与砧座壳体136的远侧壁表面148邻接的远侧部分。突片200使保持器163相对于支承构件160稳定。支座构件202联接到环形本体163a和/或突片200,并相对于中心纵向轴线“k”同轴布置。在一些实施例中,支座构件202包括多个间隔开的支座构件202。在实施例中,多个支座构件202中的每一个通过在相应的突片200与支座构件202之间延伸的连接区段204(图18)联接到相应的突片200。连接区段204限定分离区,在环形刀68致动时,内部支座构件202沿着分离区相对于突片200变形或断裂(图18)。支座构件202支撑支承构件160的内圆周并且与砧座壳体的远侧壁表面148间隔开,以将支承构件160保持在其初始纵向位置(图18),直到通过刀68(图18)将力施加到支承构件160上,以使内部支座构件202断裂或变形。
保持器162和163可由合适的弹性材料或金属材料整体形成。
参考图16和17,砧座头130'的“现有技术”砧座壳体136'(图16)通常包括沿着限定空腔150'的壁的底切137'(图16)。提供底切137'以支撑垫板160'的外圆周。对于所公开的砧座组件124,如图17的砧座壳体136所示,通过提供包括用于在缝合器械10(图1)击发之前支撑支承构件160的外圆周的支撑表面182a的外部保持器162,避免了对底切137'的需要。这充分降低了形成砧座壳体136的制造成本。
图18和19示出了包括砧座组件124的端部执行器16(图1)的使用。待连接的管状器官部分的组织端部边缘分别围绕砧座头130和仓组件22的仓壳体26放置,并通过荷包缝合或任何其它常规方法固定。砧座头130和仓组件22接近。接着击发缝合器械10(图1)以将缝钉从仓组件22中顶出,用于穿过管状器官部分的组织端部边缘并抵靠砧座壳体136的缝钉变形凹坑156变形。缝合器械10(图1)被致动以使环形刀68从图18的未致动位置推进到图19的致动位置,在所述未致动位置中,环形刀68的切割刃定位在仓组件22内,在所述致动位置中,环形刀68的切割刃定位成延伸穿过组织端部边缘并且至少部分或完全穿过切割环158。当环形刀68前进时,环形刀68接合切割环158并使切割环158和支承构件160朝向其前进纵向位置前进。此移动在外部保持器162的限定在外部保持器162的近侧台阶182与远侧台阶184之间的可变形部分190上以及内部保持器162的连接区段204上施加力,以使这些结构断裂或变形。当这些结构断裂或变形时,支承构件160和切割环158沿着砧座柱138前进,其中支承构件160的指状物174横穿砧座柱138的键槽152。此移动将指状物174从与砧座中心杆128的间隔开的臂132的远侧搁板134的接合中释放。当这种情况发生时,砧座头130自由地从砧座头30与仓组件22相对的第一操作状态(图19)枢转到第二倾斜状态(图10)。如上文关于砧座组件24(图2)所述,弹簧偏置的柱塞机构可与砧座中心杆128相关联,以偏压砧座头130以绕枢轴销40枢转,从而呈现第二倾斜状态。
图20-23示出了砧座组件的另一示范性实施例,其通常示为砧座组件324。砧座组件324还与'132专利中公开的砧座组件共享一些共同特征,并且包括砧座中心杆328和枢转地安装到砧座中心杆328的砧座头330。砧座中心杆328包括一对具有远侧搁板334的间隔开的臂332。砧座头330适于相对于砧座中心杆328在与仓组件22相对的第一操作状态(图1)与第二枢转或倾斜状态(图11)之间枢转,并且通常可经由弹簧偏置的柱塞机构(未示出)偏置到第二倾斜状态。砧座头330包括具有内部砧座柱338的砧座壳体336,所述内部砧座柱至少部分地容纳在砧座中心杆328的间隔开的臂332内。枢轴销340(图21)延伸穿过间隔开的臂332和砧座柱338的相应横向孔342、344(图20),以将砧座头330枢转地联接到砧座中心杆328。
砧座壳体336限定了砧座柱338沿其延伸的中心纵向轴线“k”(图20)。砧座壳体336包括限定远侧壁表面348的内部壳体壁346,所述远侧壁表面支撑砧座柱338并限定内部壳体凹部350。在实施例中,砧座柱338包括至少一个键槽352,并且在一些实施例中,包括径向相对的键槽352。砧座壳体336包括外接内部壳体凹部350的外部组织接触表面354。外部组织接触表面354支撑管状器官部分的组织端部边缘,并且限定多个缝钉变形凹坑356,所述缝钉变形凹坑定位成容纳从仓组件22的仓壳体26顶出的缝钉并使之变形(图21)。
砧座头330从近侧到远侧包括切割环358、薄金属支承垫圈359、顺应垫圈361、支承构件360和内部易碎或可变形保持器362。保持器362设置在砧座壳体336的内部壳体凹部350内,并且围绕砧座柱338同轴地布置(图3)。切割环358包括盘状环形本体364,所述环形本体限定用于容纳砧座柱338的中心孔366。切割环358在缝合器械10(图1)的击发期间至少部分地被环形刀68(图22)穿透,使得覆盖切割环358的组织端部边缘被环形刀68切断,以产生穿过吻合的管状器官部分的通道。在实施例中,切割环358通过模制工艺(例如,注塑模制工艺)形成,并且可以由具有硬度的材料制成,所述硬度允许环形刀68完全刺穿切割环358的环形本体364并且与支承垫圈359相接合,如以下更详细地描述。合适的材料包括聚丙烯和聚酯。也可以考虑其它材料。
支承垫圈359夹在切割环358与顺应垫圈361之间,并且包括限定中心孔382的本体380,所述中心孔容纳砧座柱338。顺应垫圈361还包括本体384,其限定容纳砧座柱338的中心孔386。使用例如粘合剂、接合剂等将支承垫圈359固定到顺应垫圈361的远侧面。在实施例中,支承垫圈359由诸如不锈钢的硬质材料的薄片形成,并且顺应垫圈361由诸如橡胶的顺应材料形成。当缝合器械10的环形刀68在缝合器械10(图1)被击发时接合切割环358时,环形刀68将穿透切割环358,并在组织正被切割时接合薄支承垫圈359并使其变形为顺应垫圈361。将薄支承垫圈359变形为顺应垫圈361将允许不平的刀68绕砧座头330的整个直径切割组织。
支承构件360配置成用于在环形刀68(图21)在砧座壳体336的内部壳体凹部350内朝向其致动位置移动时相对于砧座壳体336从初始纵向位置纵向移动到前进纵向位置。支承构件360包括外板区段370,所述外板区段限定中心孔372,所述中心孔的尺寸设置为围绕砧座壳体336的砧座柱338定位。支承构件360包括从外板区段370径向向内延伸到中心孔372中的一对径向相对的指状物374。指状物374至少部分地容纳在砧座柱338的径向相对的键槽352(图20)内,以在支承构件360在其初始纵向位置与其推进纵向位置之间移动期间相对于砧座壳体336对齐和/或引导支承构件360。指状物374还与砧座中心杆328的间隔开的臂332的远侧搁板334(图20)接合,以防止砧座头330绕枢轴销340枢转移动,并在缝合器械10(图1)击发之前将砧座头330保持在与仓组件22相对的第一操作状态。
支承构件360的外板区段370的近侧包括近侧凸起凸缘376,所述凸缘外接中心孔372,所述凸缘分别被容纳在切割环358的中心孔366以及顺应垫圈361、支承垫圈359和切割环358的中心孔386、382、366内。支承构件360的近侧凸起凸缘376可以压配合在中心孔386、382、366内,以将这些部件彼此固定。在实施例中,近侧凸起凸缘376包括唇缘378(图18),当切割环358联接到支承构件360时,所述唇缘悬于切割环358的内圆周之上。可替代地,或除此之外,支承构件360和顺应垫圈361、支承垫圈361和切割环358可使用接合剂、粘合剂、点焊工艺等联接在一起。
内部易碎或可变形保持器362包括环形本体362a,所述环形本体限定了中心孔398并包括多个(例如,四个)突片400,所述突片沿近侧方向延伸进入支承构件360的中心孔372中。本体362a包括与砧座壳体336的内壁表面348邻接的远侧部分。突片400使保持器362相对于支承构件360稳定。支座构件402联接到突片400并相对于中心纵向轴线“k”以同轴关系布置。在实施例中,支座构件402可以包括多个间隔开的支座构件402,所述支座构件经由在相应的突片400与支座构件402之间延伸的连接区段404(图21)联接到相应的突片400。连接区段404限定分离区,在环形刀68(图18)致动时,支座构件402沿着分离区相对于突片400变形或断裂。支座构件402支撑支承构件360的内圆周并且与砧座壳体336的远侧壁表面348间隔开,以将支承构件360保持在其初始纵向位置(图21),直到通过环形刀68(图22)将力施加到支承构件360上,以使支座构件402断裂或变形。
图21-23示出了包括砧座组件324的端部执行器16(图1)的使用。如上关于砧座组件24和124所述,待连接的管状器官部分的组织端部边缘围绕砧座头130和仓组件22的仓壳体26固定,并且砧座头330和仓组件22接近。当缝合器械10(图1)被击发时,环形刀68从图21的未致动位置前进到图22的致动位置,所述未致动位置,环形刀68的切割刃定位在仓组件22内,所述致动位置,环形刀68延伸穿过组织端部边缘并穿过切割环358。当环形刀68前进时,支承构件360朝向其前进纵向位置前进。此移动在内部保持器162的连接区段404上施加力,以使连接区段404断裂或变形。当连接区段404断裂或变形时,支承构件360、顺应垫圈361、支承垫圈359和切割环358沿着砧座柱338前进,其中支承构件360的指状物374横穿砧座柱338的键槽352。此移动将指状物374从与砧座中心杆328的间隔开的臂332的远侧搁板334的接合中释放。当这种情况发生时,砧座头130自由地从砧座头30与仓组件22相对的第一操作状态(图19)枢转到第二倾斜状态(图10)。如上文关于砧座组件24(图2)所述,弹簧偏置的柱塞机构可与砧座中心杆128相关联,以偏压砧座头130以绕枢轴销40枢转,从而呈现第二倾斜状态。
当支承构件360到达其在砧座壳体336内的前进纵向位置时,环形刀68将继续向远侧前进通过切割环358并进入支承垫圈359。当环形刀68前进时,支承垫圈359将向内变形为顺应垫圈361。如上所述,这种变形允许具有不平的切割边缘的刀68绕砧座头330的整个直径切割组织,并且还允许刀68切穿可位于刀68的路径中的缝钉。
本领域技术人员将理解,本文中具体描述并在附图中示出的器械和方法是非限制性的示范性实施例。可以设想,在不脱离本发明的范围的情况下,结合一个示范性实施例示出或描述的元件和特征可以与另一示范性实施例的元件和特征组合。同样,所属领域的技术人员将基于上述实施例了解本发明的其它特征和优点。因此,本发明不受特别示出和描述的内容限制,而是由所附权利要求限定。
Claims (12)
1.一种用于与圆形缝合器械一起使用的外科砧座组件,其包含:
砧座中心杆;
砧座头,其枢转地联接到所述砧座中心杆并且能够在第一操作状态与第二倾斜状态之间移动,所述砧座头包括:
砧座壳体,其限定中心纵向轴线;
支承构件,其设置在所述砧座壳体内,所述支承构件被配置成用于相对于所述砧座壳体从将所述砧座头保持在所述第一操作状态的初始纵向位置纵向移动到允许所述砧座头枢转移动到所述第二倾斜状态的前进纵向位置,所述支承构件包括具有多个力传递凸起的外板区段;和
保持器,其邻近所述支承构件定位在所述砧座壳体中,所述保持器被配置成将所述支承构件保持在所述初始纵向位置中,所述保持器包括外部保持器区段,所述外部保持器区段限定了与所述支承构件的所述力传递凸起大致纵向对齐的外部可变形区域,所述外部可变形区域被配置成由所述支承构件的所述力传递凸起接合并且在向所述支承构件施加预定纵向力时至少部分地变形,以允许所述支承构件移动到所述前进纵向位置,
其中所述砧座壳体包括壳体壁,所述保持器至少部分地定位在所述壳体壁与所述支承构件之间,
其中所述保持器包括从所述外部可变形区域径向向内的内部可变形环,所述内部可变形环被配置成由所述支承构件接合,并且在向所述支承构件施加所述预定纵向力时至少部分地变形。
2.根据权利要求1所述的砧座组件,其中所述支承构件的所述力传递凸起相对于所述中心纵向轴线同轴地布置。
3.根据权利要求2所述的砧座组件,其中所述保持器的所述外部可变形区域围绕所述中心纵向轴线同轴地布置。
4.根据权利要求3所述的砧座组件,其中所述外部保持器区段包括限定在其中的至少两个凹槽,所述外部可变形区域至少部分地限定在所述两个凹槽之间。
5.根据权利要求4所述的砧座组件,其中所述至少两个凹槽是环形的并且围绕所述中心纵向轴线同轴地布置。
6.根据权利要求1所述的砧座组件,其中所述外部可变形区域被配置成:在向所述支承构件施加所述预定纵向力时与所述支承构件的所述力传递凸起接合时,相对于所述外部保持器区段断裂。
7.根据权利要求1所述的砧座组件,其中所述内部可变形环被配置成在向所述支承构件施加所述预定纵向力时断裂。
8.根据权利要求1所述的砧座组件,包括邻近所述支承构件定位的切割环。
9.根据权利要求8所述的砧座组件,其中所述砧座头包括从所述壳体壁悬垂的砧座柱,其中所述保持器、所述支承构件和所述切割环围绕所述砧座柱同轴地安装。
10.一种用于与圆形缝合器械一起使用的端部执行器,其包含:
仓组件,其包括仓壳体和环形刀,所述环形刀被配置成用于从未致动位置到致动位置的前进移动;和
砧座组件,所述砧座组件可相对于所述仓组件安装,所述砧座组件包括:
砧座中心杆;和
砧座头,其枢转地联接到所述砧座中心杆并且能够在第一操作状态与第二倾斜状态之间移动,所述砧座头包括:
砧座壳体,其限定中心纵向轴线;
支承构件,其设置在所述砧座壳体内,所述支承构件配置成用于相对于所述砧座壳体从将所述砧座头保持在所述第一操作状态的初始纵向位置纵向移动到在所述环形刀朝向所述致动位置前进移动时允许所述砧座头枢转移动到所述第二倾斜状态的前进纵向位置,所述支承构件包括外板区段,所述外板区段具有相对于所述中心纵向轴线同轴布置的多个力传递凸起;和
保持器,其邻近所述支承构件定位在所述砧座壳体中,所述保持器被配置成将所述支承构件保持在所述初始纵向位置中,所述保持器包括外部保持器区段,所述外部保持器区段限定了相对于所述中心纵向轴线同轴地布置的并且与所述支承构件的所述力传递凸起大致纵向对齐的环形可变形区域,所述环形可变形区域被配置成由所述支承构件的所述力传递凸起接合,并且在所述环形刀朝向所述致动位置前进移动时至少部分地变形,以允许所述支承构件移动到所述前进纵向位置,
其中所述保持器包括从环形可变形区域径向向内的内部可变形环,所述内部可变形环被配置成由所述支承构件接合,并且在所述环形刀朝向所述致动位置前进移动时至少部分地变形。
11.根据权利要求10所述的端部执行器,其中所述环形可变形区域和所述内部可变形环各自被配置成在所述环形刀朝向所述致动位置前进移动时断裂。
12.根据权利要求10所述的端部执行器,其中所述支承构件包括一对径向相对的指状物,所述指状物被配置成在所述支承构件的所述初始纵向位置与所述砧座中心杆接合并且将所述砧座头保持在所述第一操作状态,并且被配置成在移动到所述前进纵向位置时释放所述砧座中心杆,以允许所述砧座头枢转移动到所述第二倾斜状态。
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EP3714811A3 (en) | 2020-11-25 |
US20200305880A1 (en) | 2020-10-01 |
US11457921B2 (en) | 2022-10-04 |
EP3714811B1 (en) | 2024-05-22 |
CN111743591A (zh) | 2020-10-09 |
EP3714811A2 (en) | 2020-09-30 |
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