CN110464399A - 通用线性外科手术缝合支撑件 - Google Patents
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Abstract
本发明公开了一种通用线性外科手术缝合支撑件。一种外科手术支撑件载架组件，其包括支撑件载架和支撑件材料。所述支撑件载架具有主体、远端和横向侧；所述载架具有在所述远端处的至少一个远侧延伸柱、在第一横向侧的至少一个第一横向延伸柱、以及在第二横向侧的至少一个第二横向延伸柱。所述支撑件载架具有邻近所述远端的内边缘和从所述内边缘延伸的近侧延伸钩。所述支撑件材料具有细长形状、远端、以及第一横向侧和第二横向侧；所述支撑件材料具有在所述远端处的至少一个开口、邻近所述支撑件第一横向侧的至少一个第一侧开口、以及邻近所述支撑件第二横向侧的至少一个第二侧开口。
Description
相关申请的交叉引用
本申请要求于2018年5月9日提交的美国临时专利申请第62/668,858号以及于2018年5月9日提交的美国临时专利申请第62/668,851号的权益和优先权，每一个申请的全部内容通过引用整体并入本文。
技术领域
本申请涉及一种外科手术支撑件组件、以及外科手术缝合装置和支撑件组件、以及将支撑件组装到外科手术缝合器的方法，更具体地涉及一种内窥镜式外科手术支撑件、内窥镜式外科手术缝合器以及组件和套件。
背景技术
随着医疗和住院费用不断增加，外科医生不断努力开发出先进的外科技术。外科领域的进步通常涉及手术技术的发展，手术技术牵涉到侵入性较小的外科手术并且减少了整体患者创伤。以这种方式，可以显著减少住院时长，因此也可以降低医院和医疗费用。
本公开包含但不限于与内窥镜外科手术一起使用，内窥镜外科手术是一项很大的进步，减少了外科手术程序的侵入性，并且改善了恢复时间。一般而言，内窥镜外科手术牵涉到通过例如体壁进行切除，在卵巢、子宫、胆囊、肠、肾、阑尾等上进行观察和/或手术。有许多常见的内窥镜外科手术程序，包含例如关节镜检查、腹腔镜检查(骨盆镜检查)、胃肠镜检查和喉镜支气管镜检查。一般而言，采用套管针形成通过其执行内窥镜外科手术的切口，并且将套管针与套管组件一起使用，以便在腹部空间中形成通路并维持气腹。套管针管或套管设备延伸到腹壁中并留在其中，以便为内窥镜手术工具提供通路。通过直径相对较大的套管针管插入摄像头或内窥镜，该套管针管一般位于舰式切口(naval incision)处并且允许对体腔进行目检和放大。然后，外科医生可以借助于专门的仪器，诸如设计成适合穿过另外的套管的镊子、切割刀、涂药器等，在外科手术部位执行诊断和治疗程序。因此，与切开主要肌肉的大切口(通常为12英寸或更大)相反，经受内窥镜手术的患者所接受的切口的外观更加美观，大小在5至10毫米之间。所以，恢复快得多，并且比传统外科手术相比，患者需要的麻醉更少。另外，由于外科手术视野被大幅放大，外科医生能够更好地剖开血管并控制失血。由于切口较小，热量损失和水份损失大幅减少。为了应对内窥镜和/或腹腔镜外科手术程序的特定需要，已经开发了内窥镜外科手术缝合设备，并且在以下专利中公开，例如：美国专利第5,040,715号(Green等人)；美国专利第5,307,976号(Olson等人)；美国专利第5,312,023号(Green等人)；美国专利第5,318,221号(Green等人)；美国专利第5,326,013号(Green等人)；以及美国专利第5,332,142号(Robinson等人)。
在许多外科手术程序(包含开放式和内窥镜外科手术中牵涉到的那些)中，通常需要进行组织缝合。在内窥镜外科手术期间特别具有挑战性，因为存在必须通过其完成组织缝合的小开口。用于此目的的器械可以包含两个细长构件，该构件分别用来捕获或夹紧组织。其中首先将组织抓紧或夹紧在相对的颚部结构之间然后通过外科手术紧固件将其接合的外科手术设备在本领域中是公知的。通常，其中一个构件承载紧固件仓，该紧固件仓容纳多个呈至少两个横向排布置的缝合钉，而另一个构件具有钉砧，该钉砧限定了用于在从缝合钉钉仓驱动缝合钉时形成缝合钉腿部的表面。紧固件通常为外科手术缝合钉的形式，但也可以采用两部分聚合物紧固件。一般而言，缝合操作由纵向行进通过缝合钉钉仓的凸轮杆或楔形件执行，其中凸轮杆作用在缝合钉推动器上以从缝合钉钉仓按顺序弹出缝合钉。刀具可以在缝合钉排之间行进，以纵向切割和/或打开缝合钉排之间经缝合的组织。例如在美国专利第3,079,606号和第3,490,675号中公开了这样的器械。
稍后在美国专利第3,499,591号中公开了一种缝合器，其在切口的每一侧上应用双排缝合钉。这是通过提供一次性装载单元来实现的，在该装载单元中，凸轮构件在两组交错的缝合钉承载凹槽之间移动通过细长的引导路径。缝合钉驱动构件位于凹槽内并且被定位成以便与纵向移动的凸轮构件接触，从而执行将缝合钉从一次性装载单元的缝合钉仓中弹出。本申请的受让人U.S.Surgical已经制造和销售内窥镜式缝合器械数年。此类器械的实例包含Multifire ENDO GIATM30和ENDO GIATM内窥镜外科手术器械。在美国专利第4,429,695号和第5,065,929号中公开了此类缝合器的其它实例。
某些内窥镜外科手术缝合器具有与缝合器手柄成一体的缝合器颚部，并且外科手术缝合钉仓是可移除且可更换的，以便继续在同一患者上使用。在其它配置中，外科手术缝合重新装载部具有缝合器颚部和可附接到缝合手柄上的主体。可以使用、移除重新装载部并使用具有新的一组准备被击发的缝合钉的重新装载部予以替换。具有预先附接到颚部的缝合器支撑件材料的重新装载部已经开发为Endo GIATM加强型重新装载部。
然而，外科手术缝合支撑件可以与缝合设备分开提供。支撑件可以和圆形外科手术缝合器、用于开放式外科手术的线性外科手术缝合器、内窥镜器械以及其它类型的缝合器和器械一起使用。
外科手术支撑件材料可以与这些器械结合使用，作为对缝合钉线的加强，以进一步促进缝合钉的正确成形，同时减少由任何未对准或异常或不均匀组织引起的扭曲/畸形。外科手术支撑件可以为弱化组织提供支撑，或者协助解决组织厚度中的差异。这些器械提供了显著的临床益处。尽管如此，还可以例如通过降低制造和/或应用的复杂性，或者通过扩大使用支撑件材料的应用范围，来进行改进。
在Shah等人的美国专利第8,348,130号中公开了一种和具有颚部的外科手术缝合装置一起使用的外科手术支撑件，所述专利的全部公开内容通过引用整体并入本文。其中公开的支撑件具有第一主体部分和第二主体部分。第一主体部分可以应用于第一颚部，该第一颚部可以是缝合装置的缝合钉钉仓，第二主体部分可以应用于第二颚部，该第二颚部可以是缝合钉砧。还公开了支撑件的第一主体部分可以附接到缝合钉钉仓替换件上。当缝合钉钉仓附接到外科手术缝合装置时，第二主体部分可以附接到钉砧。
期望外科手术支撑件的改进允许重复使用某些器械或其一部分，并容许以各种方式配置外科手术缝合器械和其它装置。
发明内容
在本公开的一个方面，外科手术支撑件载架组件包括支撑件载架和支撑件材料。支撑件载架具有主体、远端和横向侧；载架具有在远端处的至少一个远侧延伸柱、在第一横向侧的至少一个第一横向延伸柱、以及在第二横向侧的至少一个第二横向延伸柱。第一横向侧与第二横向侧相对。支撑件载架具有邻近远端的内边缘和从内边缘延伸的近侧延伸钩。支撑件材料具有细长形状、远端、以及第一横向侧和第二横向侧；支撑件材料具有在远端处的至少一个开口、邻近支撑件第一横向侧的至少一个第一侧开口、以及邻近支撑件第二横向侧的至少一个第二侧开口。该至少一个远端开口接收该至少一个远侧延伸柱，该至少一个第一侧开口接收该至少一个第一横向延伸柱，并且该至少一个第二侧开口接收该至少一个第二横向延伸柱。
在外科手术支撑件载架组件中，该至少一个远侧延伸柱可以包括第一远侧柱和第二远侧柱，该至少一个第一横向延伸柱可以包括第一侧柱和第二侧柱，并且该至少一个第二横向延伸柱可以包括第三侧柱和第四侧柱。在其它实施例中，在一个横向侧上有四个柱，在载架的另一个横向侧上有四个柱，并且在远端上有两个柱，支撑件材料具有相应的开口。
在一个实施例中，外科手术支撑件载架组件具有支撑件材料，支撑件材料具有第一远端开口和第二远端开口，第一侧开口和第二侧开口，以及第三侧开口和第四侧开口。
支撑件载架可以从支撑件材料的近端延伸到支撑件材料的远端。支撑件载架可以具有与钉砧缝合器颚部和钉仓缝合器颚部中的至少一个的形状相对应的形状。
在又一方面，缝合钉钉仓组件包括缝合钉钉仓主体，缝合钉钉仓主体在缝合钉固持狭槽中容纳多个缝合钉，容纳缝合钉推动器，并且限定了刀具狭槽。该组件包含具有主体、远端和横向侧的支撑件载架，该载架具有在远端处的至少一个远侧延伸柱，在第一横向侧的至少一个第一横向延伸柱，以及在第二横向侧的至少一个第二横向延伸柱，其中第一横向侧与第二横向侧相对，支撑件载架具有邻近远端的内边缘，以及从内边缘延伸的近侧延伸钩，该钩与缝合钉钉仓主体的刀具狭槽接合。该组件具有支撑件材料，该支撑件材料具有细长形状、远端、以及第一横向侧和第二横向侧，该支撑件材料具有在远端处的至少一个远侧开口，邻近支撑件第一横向侧的至少一个第一侧开口，以及邻近支撑件第二横向侧的至少一个第二侧开口，该至少一个远侧开口接收该至少一个远侧延伸柱，该至少一个第一侧开口接收该至少一个第一横向延伸柱，并且该至少一个第二侧开口接收该至少一个第二横向延伸柱。
该至少一个远侧延伸柱可以包括第一远侧柱和第二远侧柱，该至少一个第一横向延伸柱可以包括第一侧柱和第二侧柱，并且该至少一个第二横向延伸柱可以包括第三侧柱和第四侧柱。
该至少一个开口可以包括第一远侧开口和第二远侧开口，该至少一个第一侧开口可以包括第一侧开口和第二侧开口，并且该至少一个第二侧开口可以包括第三侧开口和第四侧开口。在其它实施例中，载架可以具有两个远侧延伸柱，在第一横向侧上的四个横向延伸柱和在第二横向侧上的四个横向延伸柱，并且支撑件材料具有相应的一组开口。
支撑件载架可以从支撑件材料的近端延伸到支撑件材料的远端。支撑件载架可以具有与钉仓缝合器颚部或钉砧颚部的形状相对应的形状。
在另一方面，一种使用外科手术缝合器的方法包括：抓紧第一支撑件载架组件，该第一支撑件载架组件具有支撑件材料；在近侧方向将第一支撑件载架组件滑动到外科手术缝合器的钉砧上，从内窥镜外科手术缝合器的缝合钉钉仓中击发缝合钉；在分割组织的同时纵向分割支撑件材料；抓紧支撑件材料的第一部分并抓紧支撑件材料的第二部分并使第一部分和第二部分彼此横向移开并远离钉砧，以及从外科手术部位移除支撑件载架和外科手术缝合器。
该方法可以包含将第二支撑件载架组件滑动到外科手术缝合器的缝合钉钉仓颚部上。
在另一方面，一种重新装载外科手术缝合器械的方法包括：提供缝合钉钉仓组件，该缝合钉钉仓组件具有其上预加载的支撑件材料；提供具有载架和支撑件材料的支撑件载架组件；使缝合钉钉仓组件与外科手术缝合器械的第一颚部接合；以及将支撑件载架组件与外科手术缝合器械的第二颚部接合，该第二颚部具有缝合钉砧。
在该方法中，支撑件材料可以限定开口，并且载架可以具有柱，该柱设置在开口中以将支撑件材料固持在载架上。
在又一方面，外科手术支撑件载架组件包括支撑件载架和支撑件材料。支撑件载架具有主体和横向侧，该载架在每个横向侧上具有多个远侧延伸臂。横向侧包含第一横向侧和第二横向侧，该第一横向侧与该第二横向侧相对。支撑件材料，其具有细长形状、远端、以及第一横向侧和第二横向侧，支撑件材料在支撑件第一横向侧和支撑件第二横向侧具有多个开口。多个开口对应于多个远侧延伸臂。支撑件载架组件具有从支撑件载架近侧延伸的细长构件，当拉动细长构件时，支撑件载架与支撑件材料分离。
细长构件可以和支撑件材料成一体，或者分离并附接到支撑件材料上。细长构件可以是缝合线。在一个实例中，在第一横向侧上有至少三个远侧延伸臂，并且在第二横向侧上有至少三个远侧延伸臂。在另一个实例中，在支撑件第一横向侧上有至少三个开口，并且在支撑件第二横向侧上有至少三个开口。
支撑件载架可以从支撑件材料的近端延伸到支撑件材料的远端。支撑件载架可以灵活贴合从钉砧缝合器颚部和钉仓缝合器颚部中选定的一个的形状。
在另一方面，外科手术支撑件部件包括细长构件、折叠部分和支撑件部分，该折叠部分折叠在该支撑件部分上。该部件形成细长的管状形状，用于接收从钉砧缝合器颚部和钉仓缝合器颚部中选定的一个，该部件进一步包括选自以下组成的组的一个特征物：穿孔、细长开口和使支撑件部分与折叠部分相分离的弱化线。
支撑件部件可以由支撑件材料形成。支撑件部件可以由选自以下组成的组的一种材料形成：织造物、非织造物和网状物。支撑件材料可以由生物可吸收聚合物形成。细长构件可以长得足以延伸内窥镜式缝合器的内窥镜轴的长度，并且可以由与支撑件材料相同的材料制成。细长构件在患者体外是可接近的。
细长构件可以是附接到折叠部分的缝合线。折叠部分可以由一个以上材料段形成。折叠部分可以由与支撑件材料相同的材料制成。此外，折叠部分可以由与支撑件部分相同的材料片制成。可以焊接折叠部分以形成管状形状，和/或将折叠部分附接到支撑件材料上。
在又一方面，一种形成外科手术缝合支撑件部件的方法包含：提供支撑件材料；形成选自以下组成的组的至少一种特征物：穿孔、开口和弱化线，该至少一个特征物限定了支撑件部分和折叠部分；形成远离支撑件部分和折叠部分延伸的细长构件，该细长构件由支撑件材料形成；将折叠部分折叠在支撑件部分上；以及将折叠部分附接到其自身或附接到支撑件部分以形成管状形状。
附图说明
根据以下结合附图的详细描述，本公开的上述和其它方面、特征和优点将变得更加显而易见，在附图中：
图1是根据本公开的示例性内窥镜外科手术缝合器的透视图；
图2是示出了在紧固件应用操作期间当按顺序击发紧固件时图1的外科手术缝合器的示例性末端执行器的放大透视图；
图2A是图2中所示的末端执行器的示例性钉砧的远端部分的底部透视图；
图3是根据本公开的某些方面的支撑件载架组件的透视图；
图4是图3中所示的支撑件载架组件的透视图，该支撑件载架组件与内窥镜式缝合器械的颚部口组装在一起；
图5是通过线性钉排附接到泡沫材料上的支撑件材料的俯视图；
图6是通过线性钉排附接到泡沫材料上的支撑件材料的俯视图，其中支撑件材料的分隔部分横向移位；
图7是附接到内窥镜式缝合器械的每个颚部的支撑件载架组件的透视图；
图8是图7中所示的支撑件载架组件和内窥镜式缝合器械的颚部的远端的横截面图；
图9是根据本公开的几个方面的内窥镜式缝合器械的透视图，该内窥镜式缝合器械具有设置在其上的支撑件部件；
图10是图9的器械的末端执行器的透视图，示出了设置在其上的支撑件部件；
图11是图9和图10的与器械分离的支撑件部件的透视图；
图12是图9-11的支撑件部件处于展开状态的平面图；
图13是根据本公开的另一个方面的内窥镜外科手术缝合器械的末端执行器的透视图，并且该内窥镜外科手术缝合器械具有设置在其上的支撑件部件。
具体实施方式
这里将参照附图对本公开的具体实施例进行描述。如附图中所示并且如在整个以下描述中所述，以及如在涉及在一对象上进行相对定位时的传统方式那样，术语“近侧”是指装置的更接近使用者的末端，而术语“远侧”是指装置的离使用者更远的末端。在以下描述中，没有详细描述公知的功能或构造，以避免在不必要的细节上使本公开模糊。
现在参照附图，在其中，相同的附图标记在多个视图中标识相同或基本相似的零件，图1示出了外科手术缝合装置10。根据本公开，外科手术缝合装置10包含壳体20或手柄以及从壳体20延伸的细长构件30。末端执行器40设置在细长构件30的一端上。末端执行器40包含第一和第二颚部50、60。第一颚部50是钉砧组件的形式，且第二颚部60接收缝合钉钉仓(staplecartridge)62(其可以是或可以不是可移除且可更换的)。参照图1和图2，缝合钉钉仓62包含钉仓壳体64，该钉仓壳体限定了纵向轴线并且包含组织接触表面65，该组织接触表面具有形成在其中的多排缝合钉固持狭槽(在本文中也称为缝合器狭槽和紧固件狭槽)66，所述缝合钉固持狭槽容纳多个紧固件或缝合钉70。如在图2A中最佳所示，多个缝合钉70可以通过在第一颚部50(钉砧组件)的组织接触表面54中限定的紧固件袋52而形成为闭合形状。
缝合钉钉仓62在刀具狭槽60a的任一侧限定了线性排的缝合钉固持狭槽66。钉砧在刀具狭槽50a的任一侧上具有相应的线性排的缝合钉袋/凹部。(图2A)。在击发缝合钉70期间，缝合钉击发机构向远侧移动通过缝合钉钉仓和钉砧，使缝合钉从狭槽中弹出，并驱动其进入钉砧袋。缝合钉击发机构向远侧移动，与缝合钉推动器相互作用，并且推动器将缝合钉驱动出狭槽66。图2中所示的缝合钉70由推动器支撑。钉砧袋52被特别成形为将缝合钉的腿部弯曲成闭合的B形形状。钉砧50具有与组织接触表面54相对的后表面51，并且颚部60具有与缝合钉钉仓的组织接触表面65相对的后表面61。参见Milliman等人的美国专利第8,256,656号中的内窥镜缝合器的实例，所述专利的全部内容通过引用整体并入本文。
如在图3中最佳所示，外科手术支撑件材料202附接到支撑件载架204以形成支撑件载架组件200。(如本文所使用的，“支撑件”包含纱布、垫片、支撑件或缝合钉线加强结构)。支撑件载架204具有主体206和至少一个从主体206向远侧延伸的柱210，该主体具有远端208。主体206可以由薄的塑料或聚合材料片形成，并且柱210可以和主体一体形成。在所示的实例中，两个远侧柱210a和210b设置在支撑件载架主体上。
支撑件载架主体206可以由塑料/聚合物材料模制、切割、挤压或以其它方式形成。用于载架主体的材料也可以是薄金属片或箔。载架主体在载架主体的远端208的内边缘212上限定了面向近侧的钩214(在图8中最佳示出)。钩214卡入或以其它方式接合刀具凹槽/狭槽，以便在击发后将套筒固持在缝合钉钉仓或钉砧上。钩214的接合应足够牢固，使得载架主体206在击发钉之后不会留在外科手术部位，而是与外科手术缝合器一起移除。
主体206具有两个横向侧206a和206b，并且在每个横向侧上具有至少一个柱220。主体的第一侧206a具有至少一个第一侧柱222，并且第二侧206b具有至少一个第二侧柱224。在所示的实例中，第一侧206a具有横向延伸并远离主体206的第一柱221、第二柱222、第三柱223和第四柱224，而第二侧206b具有横向延伸并远离主体的第五柱225、第六柱226、第七柱227、和第八柱228。第一、第二、第三和第四柱在与第五、第六、第七和第八柱延伸的方向相反的方向上延伸。柱可以略微向上(或向下)倾斜，远离支撑件材料倾斜，以进一步协助将支撑件材料固持在载架204上。
在实施例中，外科手术支撑件202的至少一部分可以由选自以下组成的组的可生物降解材料制成：天然胶原材料、肠线和合成树脂，合成树脂包含衍生自碳酸亚烃酯、碳酸三亚甲酯、碳酸四亚甲酯、己内酯、戊内酯、二恶烷酮、聚酸酐、聚酯、聚丙烯酸酯、聚甲基丙烯酸甲酯、聚氨酯、乙醇酸、乳酸、乙交酯、丙交酯、聚羟基丁酸酯、聚原酸酯、多羟基链烷酸酯、其均聚物、以及其共聚物的那些。在实施例中，外科手术支撑件110的至少一部分可以由选自以下组成的组的不可生物降解材料制成：聚烯烃、聚乙烯、聚二甲基硅氧烷、聚丙烯、聚乙烯和聚丙烯的共聚物、聚乙烯和聚丙烯的共混物、超高分子量的聚乙烯、聚酰胺、聚酯、聚对苯二甲酸乙二醇酯、聚四氟乙烯、聚醚酯、聚丁酯、聚四亚甲基醚二醇、1,4-丁二醇和聚氨酯。
支撑件材料可以是通过熔喷或熔纺方法形成的非织造材料、网状材料、编织材料和/或模塑或挤出片材。支撑件材料202具有远端230，该远端限定了至少一个开口232，该开口对应于支撑件载架204中的一个或多个远侧柱210。在所示的实例中，支撑件材料具有限定了两个开口的远端：用于接收第一远侧柱210a的第一远侧开口230a和用于接收第二远侧柱210b的第二远侧开口230b。在备选实例中，柱可以用来刺穿支撑件材料并形成开口。然而，柱优选地对组织无损伤并且具有带圆角的矩形形状(尽管可以使用其它形状)。
支撑件材料202具有横向侧开口240以对应于侧柱220。支撑件材料202限定了邻近支撑件材料202的一个横向边缘245的第一侧开口242和邻近支撑件材料202的另一个横向边缘246的第二侧开口244，以便对应于柱。在所示的实例中，支撑件材料202具有邻近一个横向边缘245的第一开口251、第二开口252、第三开口253和第四开口254，以及邻近支撑件材料的另一个横向边缘246的第五开口255、第六开口256、第七开口257和第八开口258。如以下进一步讨论的，支撑件材料202可以包含邻近支撑件的具有开口的横向部分的穿孔或弱化区域，和/或邻近支撑件材料的具有一个或多个开口的远侧部分。穿孔和/或弱化区域可以便于去除任何多余的材料。
外科手术支撑件作为包含支撑件材料202和支撑件载架204的外科手术支撑件载架组件200被单独提供和/或出售。在其它实例中，外科手术支撑件和支撑件载架被单独提供和/或出售并由使用者组装。
无论是具有可更换的缝合钉钉仓的类型，还是具有可更换的缝合重新装载部的类型，外科手术缝合器械都可以和设置在缝合钉钉仓的组织接触面上的外科手术支撑件，以及支撑件一起包装，该支撑件设置在钉砧的组织接触面上(参见图4)并且由支撑件载架204固持在其上，该支撑件载架在相应的钉仓62的相对表面61或钉砧50的相对或后表面51上延伸。相应地，在这样的实例中，支撑件载架用于在运输期间稳定支撑件材料等。
有利地，单独销售的支撑件载架组件200可以应用于任何内窥镜式钉砧或钉仓。将具有附接到支撑件载架204的外科手术支撑件材料202的支撑件载架组件200从其包装中移出。使用者抓紧支撑件载架204并将组件200操纵到外科手术缝合器械300。可能有用的是，使支撑件载架204比支撑件材料202略微更硬，以便于组件的操纵。此外，支撑件载架204可以包含突片、手柄或其它特征物，或者纹理化的表面，以便抓紧和操纵。
将组件200滑动到缝合器颚部上。细长形状的组件200对应于缝合器颚部，有利于轻松应用。支撑件材料202被自然地设置成邻近缝合钉钉仓或钉砧的组织接触表面。支撑件载架204的形状可以提示组件的正确应用，因为其对应于颚部后部的弯曲形状。可以从载架204中略去钩214，并且在这种情况下，组件200通过载架204和颚部之间以及支撑件材料202和颚部之间的摩擦力固持在颚部上。另选地，组件200可以使用粘合剂附接到器械颚部，使用缝合线绑定在器械颚部上，或者通过一些其它方法附接。
一旦将组件200应用于每个颚部，由于在使用外科手术支撑件时通常将支撑件应用到缝合钉钉仓颚部304和钉砧颚部306两者，所以通过套管针或其它通路设备将缝合器械300引入外科手术部位。如常操作缝合器300，并且将缝合钉击发到组织中，横切组织。当组织被横切时，支撑件材料202也被分成第一部分202a和第二部分202b。在图5中所示的实例中，分开的支撑件材料202包含仍附接到组织的远侧突片260。该远侧突片260可以保持在患者体内，或者可以使用手术刀或外科手术剪来移除。在本文公开的任何实例中，支撑件材料202可以包含邻近支撑件的具有开口的部分的穿孔，使得可以去除多余的材料。
为了从缝合器械300和载架204中移除支撑件材料202，抓紧并横向移动支撑件的第一部分202a，并在与第一部分相反的横向方向上移动支撑件的第二部分202b(参见图5和图6)。以这种方式，支撑件材料从缝合器300和载架204滑出。载架204可以使用缝合器械300来移除，或者可以被单独移除。
在本文公开的任何实施例中，载架可以成形为对应于其要与之组装的特定颚部(参见图4)。在一个实例中，载架304具有与钉砧306的后侧对应的形状，并且载架204对应于钉仓颚部的后侧。在图7和图8中，钉砧的轮廓较低并且在形状上比钉仓颚部更弯曲，钉仓颚部更深并且可以是圆形或更加矩形的形状。在其它实例中，载架204可以包含穿孔，以便于在使用后从器械移除。
在图8中，支撑件载架204设置在钉仓颚部上，而支撑件载架304设置在钉砧50上。支撑件载架204具有与刀具狭槽60a接合的钩214，并且支撑件载架304具有与刀具狭槽50a接合的钩314。
图4示出了外科手术缝合器的缝合钉钉仓颚部304和钉砧颚部306上的支撑件载架组件。在具有可移除且可更换的缝合钉钉仓组件的器械中，缝合钉钉仓组件可以具有由制造商预装载到其上的支撑件。在这些情况下，使用者可以利用准备安装在器械的钉砧上的，单独包装的支撑件载架组件200。使用上面讨论的支撑件载架组件，可以将外科手术支撑件材料附接到外科手术缝合钉砧上。以这种方式，外科手术缝合器械可以通过用缝合钉钉仓组件重新装载而在同一患者身上重复使用，该缝合钉钉仓组件具有准备击发的新的一组缝合钉和新的支撑件材料。如上所讨论的，支撑件载架组件方便地应用于缝合器钉砧。
在本文公开的任何实施例中，缝合钉钉仓组件容纳除缝合钉之外的外科手术紧固件。此外，具有支撑件载架组件的缝合钉钉仓组件可以布置成与开放式缝合器械、圆形缝合器械或其它类型的器械一起使用。
在本文公开的任何实施例中，支撑件载架组件200可以包含缝合线、具有Velcro或其它附接特征物的绑带、粘合剂等，或者可以与其一起使用。
在本文公开的任何实施例中，外科手术支撑件材料202可以包含近距离放射治疗、化疗、其它医疗材料或药物，或者可以与其一起使用。支撑件材料可以具有袋、孔或用于用支撑件固持近距离放射治疗粒子的其它特征物，或者可以将近距离放射治疗粒子或材料并入到一根或多根穿入或穿过支撑件材料或以其它方式附接到其上的缝合线中。通过喷涂或浸渍，可以将具有近距离放射治疗材料的涂层应用到支撑件材料上。化疗药物或药剂可以并入到支撑件的材料中，涂覆于其上，或者作为缝合线的一部分或缝合线或其它特征物而被应用。
一般而言，线性缝合器(包含开放式和内窥镜式设备)可以具有两个细长构件，其分别用来捕获或夹紧组织。通常，其中一个构件承载缝合钉仓，该缝合钉仓容纳多个至少布置成两个横向排的缝合钉，而另一个构件具有钉砧，该钉砧限定了用于在从缝合钉钉仓驱动缝合钉时形成缝合钉腿部的表面。一般而言，缝合操作通过纵向行进通过缝合钉钉仓的凸轮杆执行，其中凸轮杆作用在缝合钉推动器上以从缝合钉钉仓按顺序弹出缝合钉。刀具可以在缝合钉排之间行进，以纵向切割和/或打开缝合钉排之间经缝合的组织。例如在美国专利第6,202,914号中公开了这种器械，所述专利的全部内容通过引用整体并入本文。
某些缝合器在切口的每一侧上应用双排缝合钉。这是通过提供一次性装载单元来实现的，在该装载单元中，凸轮构件在两组交错的缝合钉承载凹槽之间移动通过细长的引导路径。缝合钉驱动构件位于凹槽内并且被定位成以便与纵向移动的凸轮构件接触，从而执行将缝合钉从一次性装载单元的缝合钉仓中弹出。在美国专利第5,065,929号中公开了这种缝合器的实例，所述专利的全部内容通过引用整体并入本文。
以上描述的一些器械被设计成用于常规外科手术程序中，其中外科手术医生直接手动接近外科手术部位。然而，在内窥镜或腹腔镜手术程序中，外科手术是通过小切口或通过穿过皮肤中的小入口伤口插入的狭窄套管进行的。为了满足内窥镜和/或腹腔镜外科手术程序的特定需要，已经开发了内窥镜外科手术缝合设备，并且公开在，例如，美国专利第5,865,361号中，所述专利的全部内容通过引用整体并入本文。
进一步设想的是，外科手术支撑件可以被配置成与圆形缝合装置或半圆形缝合装置一起使用。用于将环形阵列的缝合钉或紧固件应用到组织的外科手术缝合设备在本领域中是公知的。这些设备通常包含用于控制紧固件组件和设备远端处的钉砧构件之间的间隔的工具。紧固件组件一般包含圆形阵列的紧固件(诸如缝合钉)，而钉砧构件包含用于完成圆形缝合的工具(通常是在从紧固件组件中排出缝合钉之后钉牢缝合钉的桶形构件阵列)，或者可以包含用于缝合环的锁定构件。通常，用于使钉砧相对于紧固件组件前进或缩回的工具包含位于器械近端的翼形螺母型机构或可旋转的旋钮构件，二者都与手柄机构中的蜗轮布置装置接合，以便缓慢地且有条理地使钉砧构件朝向紧固件组件前进。
在使用中，圆形器械定位在器官(诸如胃、食道或肠)的腔内，以进行缝合术。组织定位在钉砧和紧固件组件之间，并且通常，例如通过荷包缝合线系住。此后，通过在器械的近端处旋转可旋转的旋钮或翼形螺母组件，使钉砧构件朝向紧固件组件前进，以将组织保持在钉砧构件和紧固件组件之间。当从紧固件组件中排出缝合钉或紧固件时，圆形刀具通常在施加缝合钉之后切除缝合部位处不需要的组织。然后将器械从器官的腔中取出。
例如在美国专利第5,915,616号中公开了圆形器械，所述专利的全部内容通过引用整体并入本文。
在另一个Nobis等人(“Nobis”)的美国专利第5,137,198号中，公开了一种紧固件施加设备，其包含通过推进机构朝向钉砧组件前进的钉仓。推进机构包含：第一致动器构件，其用于以加速的速率朝向钉砧组件推进钉仓；以及第二致动器构件，其与第一致动器构件间隔开，用于使钉仓朝向钉砧组件以递增的方式前进。美国专利第5,964,394号公开了外科手术缝合器的另一个实例，所述专利的全部内容通过引用整体并入本文。
在又一个实施例中，支撑件部件500可以由支撑件材料形成，并且可以包含细长构件502、折叠部分504和支撑件部分506。支撑件部分506附接到折叠部分并且通过穿孔特征物508与折叠部分分离。细长构件502长得足以延伸内窥镜式缝合器600的内窥镜轴602的长度，并且在患者体外是可接近的。另选地或另外地，缝合线附接到细长构件，或者附接到折叠部分504。当折叠部分折叠到支撑件部分上时，形成管状形状510。管状形状510足够大，并且成形为便于接收缝合器钉砧604或缝合器钉仓颚部606。当拉动细长构件502时，折叠部分和细长构件与支撑件部分分离。穿孔特征物可以省略。折叠部分可以是一个或多个材料段，并且可以由与支撑件材料相同的材料制成，或者由不同的材料制成。可以焊接一个或多个折叠部分，或者可以使用粘合剂，以形成管状形状。另选地，支撑件材料可以类似地附接到一个或多个折叠部分或者附接到自身。
从图9中可以看出，支撑件部件500设置在内窥镜式缝合器械的钉砧上。折叠部分502围绕钉砧的与组织接触侧604b相对的侧604a设置。细长构件502沿器械的轴602向下延伸，并且可以终止于手柄602a或其它可抓握部分中。
穿孔特征物508可以是支撑件材料中的小针孔、支撑件材料中的较大开口508a，或者由将支撑件部分506附接到折叠部分504的单独构件形成。穿孔特征物508可以是单个特征物，诸如一种或多种材料中的弱化线。在图10中，示出了较大的开口，并且支撑件材料是非织造聚乙交酯材料，但是可以使用其它生物相容物、生物可吸收物、织造物、非织造物、网状物、聚合物和共聚物。可以使用激光、切割刀片或其它方法形成开口。用于支撑件材料的材料可以是如上所讨论的。在一个实例中，部件500由一片非织造聚乙醇酸制成并且经激光切割以形成本文所讨论的特征物。
折叠部分504可以焊接到其自身或支撑件部分506。如图11中所示，第一折叠部分512焊接到支撑件部分任一侧上的第二折叠部分514。细长构件502可以和支撑件部分和/或一个或多个折叠部分成为一体。在图11中，细长构件502通过焊接附接到折叠部分(在513处)，并且可以是与一个或多个折叠部分和/或支撑件部分506相同的材料。
整个支撑件部件可以由单个材料片形成。如图12中所示，从片材切割起始材料520，并在其中形成穿孔特征物508。部件500具有第一折叠部分512，第二折叠部分514，支撑件部分506和细长构件502。折叠部分512、514可以在将部件500设置在钉砧604上或周围之前折叠，或者在将部件500应用于钉砧604时折叠。一个或多个折叠部分和支撑件部分可以通过焊接、使用粘合剂、通过用缝合线系住等方式附接到彼此。
为了在击发缝合钉之后移除缝合器械，拉动细长构件502，并且将支撑件部分从折叠部分分离。器械、一个或多个折叠部分、以及细长构件可以一起或单独地从外科手术部位移除。因此，将支撑件部分缝合到组织上，并且将部件的其余部分从支撑件部分扯开。
在本公开的另一个实施例中，支撑件组件800具有载架802、支撑件材料804和细长构件606。如图13所示，细长构件606可以是缝合线608，或者可以是载架802的延伸部并与其成为一体。载架802可以由非常薄的材料片形成，诸如ABS(丙烯腈-丁二烯-苯乙烯)塑料、聚酯薄膜、聚酯或任何生物相容性材料。优选地，载架802非常薄，诸如一英寸的约千分之0.003至约千分之0.008。例如，载架802可以是薄的柔性聚酯片，其厚度为一英寸的约千分之0.006。
载架802被形成为有细长形状并且柔性贴合缝合钉器械钉砧604的形状。长侧604a和604b具有远侧延伸臂808，用于直接接合支撑件材料804。支撑件材料804具有从钉砧604的组织接触表面向上延伸的侧804a和804b。在击发仪器后，侧804a和804b可以与支撑件材料804的其余部分分离，并且可以提供穿孔或弱化线。支撑件材料804在支撑件材料804的两侧具有开口805，用于接收载架802的臂808。
在击发缝合器械后，拉动细长构件606并且将载架与支撑件材料804分离。从外科手术部位移除支撑件材料和细长构件。臂在缝合器器械末端执行器的远端方向上具有钩形形状，可以依靠臂的形状来固持支撑件材料，或者可以使用某种粘合剂。另外，可以使用某种粘合剂将支撑件组件800或支撑件部件500固持在缝合器械上，或者可以依靠摩擦力进行固持。细长构件606可以是载架的一部分，或者可以附接到载架上，或者可以使用缝合线812。
虽然已经在附图中示出了本公开的若干实施例，但并不旨在将本公开限制于此，因为旨在使本公开与本领域所允许的范围一样广泛并且应以同样的方式阅读本说明书。所以，以上描述不应被解释为限制性的，而仅仅为优选实施例的举例说明。因此，实施例的范围应当由所附权利要求书及其合法等同物确定，而不是由给出的实例确定。
Claims (20)
1.一种外科手术支撑件载架组件，其包括：
支撑件载架，其具有主体和横向侧，所述载架在每个所述横向侧上具有多个远侧延伸臂，所述横向侧包括第一横向侧和第二横向侧，所述第一横向侧与所述第二横向侧相对；以及
支撑件材料，其具有细长形状、远端、以及第一横向侧和第二横向侧，所述支撑件材料在所述支撑件第一横向侧和所述支撑件第二横向侧具有多个开口，所述多个开口对应于所述多个远侧延伸臂；以及
细长构件，其从所述支撑件载架的近侧延伸，当拉动所述细长构件时，所述支撑件载架与所述支撑件材料分离。
2.根据权利要求1所述的外科手术支撑件载架组件，其中，所述细长构件与所述支撑件材料成一体。
3.根据权利要求1所述的外科手术支撑件载架组件，其中，所述细长构件附接到所述支撑件材料。
4.根据权利要求3所述的外科手术支撑件载架组件，其中，所述细长构件是缝合线。
5.根据权利要求1所述的外科手术支撑件载架组件，其中，在所述第一横向侧上有至少三个远侧延伸臂，并且在所述第二横向侧侧上有至少三个远侧延伸臂。
6.根据权利要求1所述的外科手术支撑件载架组件，其中，在所述支撑件第一横向侧上有至少三个开口，并且在所述支撑件第二横向侧上有至少三个开口。
7.根据权利要求1所述的外科手术支撑件载架组件，其中，所述支撑件载架从所述支撑件材料的近端延伸到所述支撑件材料的远端。
8.根据权利要求1所述的外科手术支撑件载架组件，其中，所述支撑件载架柔性贴合从钉砧缝合器颚部和钉仓缝合器颚部中选定的一个的形状。
9.一种外科手术支撑件部件，其包括细长构件、折叠部分和支撑件部分，所述折叠部分折叠在所述支撑件部分上，所述部件形成细长管状形状，用于接收从钉砧缝合器颚部和钉仓缝合器颚部中选定的一个，所述部件进一步包括选自以下组成的组的特征：穿孔、细长开口以及将所述支撑件部分与所述折叠部分相分离的弱化线。
10.根据权利要求9所述的外科手术支撑件部件，其中，所述支撑件部件由支撑件材料形成。
11.根据权利要求10所述的外科手术支撑件部件，其中，所述支撑件部件由选自以下组成的组的一种材料形成：织造物、非织造物和网状物。
12.根据权利要求10所述的外科手术支撑件部件，其中，所述支撑件材料由生物可吸收聚合物形成。
13.根据权利要求9所述的外科手术支撑件部件，其中，所述细长构件长得足以延伸内窥镜式缝合器的内窥镜轴的长度。
14.根据权利要求9所述的外科手术支撑件部件，其中，所述细长构件在患者体外是可接近的。
15.根据权利要求9所述的外科手术支撑件部件，其中，所述细长构件是附接到所述折叠部分的缝合线。
16.根据权利要求9所述的外科手术支撑件部件，其中，所述折叠部分是一个以上材料段。
17.根据权利要求9所述的外科手术支撑件部件，其中，所述折叠部分由与所述支撑件材料相同的材料制成。
18.根据权利要求9所述的外科手术支撑件部件，其中，所述折叠部分由与所述支撑件部分相同的材料片制成，或者所述细长构件由与所述支撑件部分相同的材料片制成，或者所述一个或多个折叠部分和所述细长构件均由与所述支撑件部分相同的材料片制成。
19.根据权利要求9所述的外科手术支撑件部件，其中，焊接所述折叠部分以形成所述管状形状。
20.根据权利要求9所述的外科手术支撑件部件，其中，所述折叠部分附接到所述支撑件材料。
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| US16/388,080 US11426163B2 (en) | 2018-05-09 | 2019-04-18 | Universal linear surgical stapling buttress |
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| US11653919B2 (en) * | 2020-11-24 | 2023-05-23 | Covidien Lp | Stapler line reinforcement continuity |
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- 2019-04-29 AU AU2019202984A patent/AU2019202984A1/en not_active Abandoned
- 2019-05-07 CN CN201910375576.9A patent/CN110464399B/zh active Active
- 2019-05-08 EP EP19173233.8A patent/EP3566658A3/en not_active Withdrawn
- 2019-05-08 EP EP20207294.8A patent/EP3797710A1/en not_active Withdrawn
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Also Published As
| Publication number | Publication date |
|---|---|
| EP3566658A3 (en) | 2020-04-01 |
| CN110464399B (zh) | 2024-12-17 |
| CA3041249A1 (en) | 2019-11-09 |
| EP3566658A2 (en) | 2019-11-13 |
| JP2019195626A (ja) | 2019-11-14 |
| AU2019202984A1 (en) | 2019-11-28 |
| EP3797710A1 (en) | 2021-03-31 |
| JP7423195B2 (ja) | 2024-01-29 |
| US20190343522A1 (en) | 2019-11-14 |
| US11426163B2 (en) | 2022-08-30 |
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