CN102686169A - 用于穿过小递送端口施加大缝钉的手术缝合器和利用该缝合器固定组织褶皱的方法 - Google Patents
用于穿过小递送端口施加大缝钉的手术缝合器和利用该缝合器固定组织褶皱的方法 Download PDFInfo
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Abstract
本发明提供了一种通过下述方式将外科紧固件部署至患者体内的方法:将紧固件引导至患者体内,同时所述紧固件处于第一形状,所述第一形状具有第一套环,所述第一套环具有背跨距部以及初始尺寸和形状。该方法然后涉及使所述紧固件的端部区段基本上沿着其整个长度远离彼此运动,同时保持所述背跨距部基本上处于其初始尺寸和形状。该方法然后涉及将所述紧固件成形为第二套环,所述第二套环的宽度大于所述第一套环的宽度。
Description
技术领域
本发明总体涉及用手术缝合器接合腔壁组织,更具体地讲,本发明涉及用于穿过小递送端口向体腔递送多个大尺寸框形缝钉的薄型缝合器。薄型缝合器使得通过小进入端口在体腔的内部将大面积的组织接合到一起成为可能。本发明还涉及在微创外科手术(诸如胃减容术)操作过程中使用薄型缝合器使体腔内的组织靠近的方法。本发明还涉及通过牢固的组织并置闭合体上或体内的缺陷。本发明还涉及通过叠盖用薄型缝合器固定的扣紧的区域而增强扣紧的组织。本发明还涉及将假体(诸如用于修复疝气的网片)附接到组织。
背景技术
肥胖症是影响超过30%美国人口的医学病症。肥胖症影响个人的生活质量,并且显著提高了发病率和死亡率。肥胖症最通常由体重指数(BMI)定义,BMI是考虑人的体重和身高以测量身体总脂肪的测量值。这是一种简单、快速、和低成本的测量值,其与发病率和死亡率二者相联系。BMI为25kg/m2至29.9kg/m2定义为超重,BMI为30kg/m2定义为肥胖症。BMI≥为40kg/m2或超重100lbs定义为病态肥胖症。据估计,肥胖症及其共病症每年直接和间接的保健费用花费超过1000亿美元。与肥胖症相关的共病症有:2型糖尿病、心血管疾病、高血压、血脂异常、胃食管反流性疾病、阻塞性睡眠呼吸暂停、尿失禁、不育、承重关节的骨关节炎、和一些癌症。这些并发症可影响身体的所有系统,并消除肥胖症只是美观问题的误解。研究表明,仅采用节食和锻炼的保守疗法对减少许多病人超出的体重而言可能是无效的。
已经开发出用于内卷胃腔壁以减小胃容积的外科手术,以作为治疗肥胖症的手段。在胃减容(GVR)手术(例如,减小胃成形术、胃褶皱、胃大弯褶皱、前表面褶皱等)中,穿过胃腔壁部署多对缝合线锚固装置(例如T接头锚)。优选地,在微创外科手术操作中,穿过小直径端口部署缝合锚,以减轻对患者造成的创伤。在部署T接头锚后,将附接到每一对单独的锚的缝合线系紧以使组织靠近,并固定缝合线以在锚之间内卷腔壁。在共同待审的美国专利申请No.11/779314和No.11/779322中更详细地描述了此种手术,所述专利申请均以引用方式全文并入本文中。尤其值得关注的手术变型包括以下情况:围绕胃前表面的中线进行内卷;和在沿胃大弯移除或释放附连点(如将短胃脉管切开,将网膜从胃壁切开等)后围绕胃大弯内卷。可使用定径装置(例如探条)来帮助确定要减小的容量正确量。用于较大曲率褶皱的示例性探条的尺寸在30-40French范围内,但是也可以使用高达60French的尺寸。小于30French的尺寸可以用在外科诊断中。对传统探条的改进将提供可操纵性、有目的地(例如,在角切迹、窦腔等处)或广义地沿着治疗长度的可调式尺寸、工作中可视化等,可利用所述对传统探条的改进以方便放置和形成褶皱。
该手术的一个作用是更快速地引起饱食感,本文将这种作用定义为就餐期间实现饱腹程度,以有助于调节进食量。该手术的另一个作用是延长饱食感的效果,本文将这种作用定义为延迟餐后饥饿感的出现,其又调节进食的频率。以非限制性举例的方式,通过经下列机制中的一种或多种进行的GVR手术可以实现对饱食感和饱腹感的积极影响:胃容积减小、牵张感受器快速接合、胃能动性改变、压力引起的胃肠激素水平改变、以及对食物流入或流出胃部的改变。例如,对于给定体积的食物,容积减小的胃部将更迅速地扩张。这种胃扩张可以触发牵张感受器,继而触发饱食感。又如,该手术将限制胃部的膨胀能力,从而有效地减小其容量或填充体积。另外,由于牵张感受器在胃的某些区域中更快速地触发,或由于通过消除触发机制而防止在不再以相同方式进行牵张的折叠区域中触发激素的释放,该手术可以引起有益的激素效应。再如,该手术可以通过防止有效的胃窦收缩而改变胃排空。另外,折叠的区域可以提供刚好远离食管胃接合处的进入胃中的限制性入口。
在这些申请中描述的GVR手术需要将每一对缝合锚都单独放置到腔壁组织中,并且随后在锚对之间拉紧缝合线,以便使组织内卷。这种对T接头锚的单独放置和手动拉紧缝合线需要大量的时间,从而增加了GVR手术的持续时间、复杂性和成本。因此,希望具有用于在腹膜腔内形成组织褶皱的更简单、更快速且成本更低的方式。
已知在吻合术、皮肤缝合、或其它外科手术后使用手术缝钉将身体组织结合和保持在一起。传统地,这些缝钉在未变形状态下具有宽的U形形状,需要大切口部位或宽直径的套管针套管来容纳缝钉和缝合器。已经开发出在直径较小(即5mm或10mm)的套管针中使用的薄型缝钉和缝合器。然而,这些装置存在多个缺点,使其在GVR手术中不实用。具体地讲,这样的缝合器需要将缝钉从部署前在缝合器中的层叠状态弯曲整整180°,以形成在组织中的闭合的经部署的状态。要达到这种程度的塑性变形,需要缝钉由柔软的延性材料(如柔软的钛)构成。然而,使用柔软的延性材料会降低所形成的缝钉的强度和保持力,从而使缝钉在没有不切实际数量的缝钉的情况下不适合于与内卷胃腔壁相关的压力。另外已经开发出用于通过薄型缝合器部署的具有三角形预击发构型的缝钉。然而,这些缝钉的三角形形状会妨碍缝钉穿过缝合器轴被堆叠和纵向给料。相反,这些缝钉在缝合器内被垂直地堆叠和给料,这会减少可从缝合器部署的缝钉数量,同时仍保持低的轮廓直径。由于某些形式的GVR手术可能需要大量缝钉来内卷胃腔壁,垂直堆叠使得必须使用不止一个的缝合器来完成手术。另外,先前的缝合器在形成和部署过程中在三个或更少的点处具有弯曲的缝钉,这样减小了加工硬化量,从而减小了形成的缝钉内的加固作用。
因此,为了有利于GVR和其他外科手术,希望具有用于在腹膜腔内紧固组织层的改良的外科手术缝钉和部署缝合器。期望的是,缝合器具有薄型,以用于穿过小直径腹腔镜式端口、包括多个小的腹腔镜式端口的单个套管针,或者穿过半刚性或柔性的内窥镜式平台(例如,用于自然孔口外科手术中),但仍然能够以大的组织提升来部署缝钉。此外,希望缝钉具有折叠的框形形状,并且在手术过程中用单个缝合器可递送大量缝钉。另外,希望具有这样的缝合器,该缝合器将缝钉的构型从部署前的薄型、缩小的宽度变成部署后更宽的可操作宽度。此外,希望缝钉由具有高屈服应力的强效材料构成,并且成形过程包括形成大于3个弯曲点,以增加形成的缝钉的强度。本发明提供实现这些目标的手术缝钉和缝合器。
发明内容
本发明提供一种在组织并置手术(例如胃减容手术)期间用于部署缝钉的薄型手术缝合器。该缝合器包括具有至少一个致动器的柄部。所述手柄连接至具有远侧和近端的细长的缝合器外壳。缝钉的堆叠沿纵向穿过外壳而进给至打开的缝合器端部。缝钉在缝合器外侧单独地前进,并且响应于致动器而张开。在缝钉刺穿或以其他方式接合待联接的组织部分之后,缝合器将张开的缝钉腿部向内拉回,以形成穿过组织的缝钉。
本发明还提供具有小外形的缝钉,以用于穿过薄型缝合器而进给。缝钉在进给期间呈小宽度、闭合的套环状态。在部署期间,缝钉转变至第二状态,该第二状态中具有用于夹持组织的较大宽度的开口。在夹持到一个或多个组织部分上之后,缝钉转换至不同的第三闭合状态,其中组织被缝钉腿部牢固地保持。不同状态之间的转换时的塑性变形区域相异,以有助于在缝钉背跨距部的较长长度范围内加工硬化,从而增加缝钉的强度。
另外,本发明提供用于在腹膜腔内卷绕和固定组织的方法。该方法包括使缝钉前进并移出薄型缝合器的开口端并且将缝钉打开至张开状态,在该张开状态中缝钉尖头面向待连接的组织区域的方向。单独的间隔开的组织部分被缝钉尖头夹持和并置。缝合器形成穿过尖头之间的组织的缝钉,以将并置的组织保持在一起。
附图说明
图1为示出处于初始未部署状态的本发明的示例性缝钉实施例的俯视图;
图2为示出处于中间部署状态的图1的缝钉的俯视图;
图3为图1的缝钉的俯视图,其示出处于最终部署状态的缝钉;
图4为本发明的示例性薄型手术缝合器的等轴视图;
图5为图4的手术缝合器的近端的等轴视图,其示出已局部移除柄部覆盖件;
图6为图4的缝合器的局部剖视的等轴视图;
图7为图4的缝合器的远端的分解等角视图;
图8为缝合器的远端的沿图6的线9-9截取的剖视图;
图9为缝合器的远端视图;
图10A为形成器本体的局部剖视的俯视分解图;
图10B为形成器本体的局部剖视的侧视分解图;
图10C为形成器本体的局部剖视的等轴视图;
图11A为形成器端盖的局部剖视的俯视分解图;
图11B为形成器端盖的局部剖视的侧视分解图;
图11C为形成器端盖的局部剖视的等轴视图;
图12A为夹具的侧视图;
图12B为夹具的俯视图;
图12C为夹具的等轴视图;
图13A为缝钉分度器(indexer)的俯视图;
图13B为缝钉分度器的侧视图;
图13C为缝钉分度器的等轴视图;
图13D为缝钉分度器的底部透视图;
图14A为砧座的侧视图;
图14B为砧座的俯视图;
图14C为砧座的等轴视图;
图15A为砧座分离器的分解侧视图;
图15B为砧座分离器的分解俯视图;
图15C为砧座分离器的分解等轴视图;
图16为示出缝合器的远端的局部剖视的分解等轴视图,其示出初始部署位置;
图17为已移除缝钉引导件和缝钉分度器的远侧缝合器端部的局部俯视剖视图,其示出初始部署位置;
图18为处于初始部署状态的缝合器的近端的侧视剖视图;
图19为缝合器柄部部件的分解等轴视图;
图20为处于初始部署状态的缝合器的近端的等轴剖视图;
图21为沿缝合器纵向轴线截取的缝合器的远端的侧视剖视图,其示出缝钉部署组件处于初始部署状态;
图22为远侧缝合器端部的侧视分解局部剖视图,其示出缝钉部署组件处于初始部署状态;
图23为缝合器的近端的侧视剖视图,其示出分离器驱动器向远侧运动以使分离器和夹具前进;
图24为缝合器的近端的等轴剖视图,类似于图23,其示出分离器驱动器向远侧运动以使分离器和夹具前进;
图2为缝合器的远端的等轴局部剖视图,示出了夹具和缝钉靠着砧座向远侧前进;
图26为沿缝合器纵向轴线截取的缝合器的远端的侧视剖视图,其示出在部署过程的第二阶段期间夹具靠着缝钉和砧座向远侧前进;
图27为远侧缝合器端部的侧视分解局部剖视图,与图26类似,其示出夹具和缝钉靠着砧座向远侧前进;
图28为已移除缝钉引导件和缝钉分度器的远侧缝合器端部的俯视局部剖视图,其示出与图26类似的部署阶段;
图29为缝合器的远端的分解等轴视图,其示出在打开的缝合器端部外侧通过夹具和砧座尖齿保持处于完全前进位置中的缝钉;
图30为沿缝合器纵向轴线截取的缝合器的侧视剖视图,其示出在部署过程的中间阶段期间通过砧座和夹具保持在打开的缝合器端部外侧的缝钉;
图31为远侧缝合器端部的侧视分解局部剖视图,其示出在打开的缝合器端部外侧处于完全前进位置中的夹具、缝钉和砧座尖齿;
图32为缝合器的近端的侧视剖视图,其示出用于砧座和夹具的远端阻挡件,以及进一步向远侧驱动砧座分离器的分离器触发器;
图33为缝合器的近端的等轴剖视图,其示出与图32相同的部署阶段;
图34为远侧缝合器端部的俯视局部剖视图,其示出在部署过程的中间阶段期间通过砧座和夹具保持在缝合器外侧的缝钉;
图35为缝合器的远端的等轴分解局部剖视图,其示出在打开的缝合器端部外侧通过砧座和分离器张开的缝钉;
图36为沿缝合器纵向轴线截取的远侧缝合器端部的侧视剖视图,其示出在打开的缝合器端部外侧通过砧座和分离器张开的缝钉;
图37为远侧缝合器端部的侧视分解局部剖视图,其示出在打开的缝合器端部外侧通过砧座和分离器张开的缝钉;
图38为远侧缝合器端部的俯视局部剖视图,其示出在打开的缝合器端部外侧张开的缝钉;
图39为近侧缝合器端部的侧视剖视图,其示出分离器触发器,其完全致动到用于分离器、砧座和夹具的远端阻挡件;
图40为缝合器的近端的等轴剖视图,其示出与图39相同的部署阶段;
图41为缝合器的近端的等轴剖视图,其示出处于完全枢转位置中的分离器和形成器触发器;
图42为近侧缝合器端部的侧视剖视图,与图41类似,其示出处于完全枢转位置中的分离器和形成器触发器;
图43为远侧缝合器端部的局部剖视的分解等轴视图,其示出通过形成器端盖形成的缝钉;
图44为沿缝合器纵向轴线截取的远侧缝合器端部的侧视剖视图,其示出形成的缝钉;
图45为远侧缝合器端部的侧视分解局部剖视图,其示出与图44相同的部署阶段;
图46为远侧缝合器端部的俯视局部剖视图,其示出与图44相同的部署阶段;
图47为缝合器的远端的局部剖视的分解等轴视图,其示出从形成的缝钉缩回的形成器;
图48为沿缝合器纵向轴线截取的远侧缝合器端部的侧视剖视图,其示出与图47相同的部署阶段;
图49为远侧缝合器端部的侧视局部剖视图,其示出与图47相同的部署阶段;
图50为远侧缝合器端部的俯视局部剖视图,其示出与图47相同的部署阶段;
图51为近侧缝合器端部的侧视剖视图,其示出使分离器触发器棘爪缩回打开和行进的形成器触发器;
图52为缝合器的近端的等轴剖视图,其示出与图51相同的部署阶段;
图53为近侧缝合器端部的侧视剖视图,其示出缩回打开的分离器和形成器触发器;
图54为缝合器的近端的等轴剖视图,其示出与图53相同的部署阶段;
图55为远侧缝合器端部的俯视局部剖视图,其示出在缝钉释放之前从缝钉和砧座尖齿缩回的夹具;
图56为缝合器的远端的局部剖视的分解等轴视图,其示出与图55相同的部署阶段;
图57为沿缝合器纵向轴线截取的远侧缝合器端部的侧视剖视图,其示出与图55相同的部署阶段;
图58为远侧缝合器端部的侧视分解局部剖视图,其示出与图55相同的部署阶段;
图59为缝合器的近端的等轴剖视图,其示出被释放以完全缩回砧座的砧座扣件;
图60为近侧缝合器端部的侧视剖视图,其示出与图59相同的部署位置;
图61为缝合器的远端的局部剖视的分解等轴视图,其示出在缝钉释放之后在缝合器外壳内缩回的砧座尖齿;
图62为沿缝合器纵向轴线截取的远侧缝合器端部的侧视剖视图,其示出与图61相同的部署阶段;
图63为远侧缝合器端部的侧视分解局部剖视图,其示出与图61相同的部署阶段;
图64为远侧缝合器端部的俯视局部剖视图,其示出与图61相同的部署阶段;
图65为缝合器的近端的等轴剖视图,其示出近端阻挡件处的砧座和被释放以完全缩回夹具的夹具扣件;
图66为近侧缝合器端部的侧视剖视图,其示出与图65相同的部署位置;
图67为缝合器的远端的局部剖视的分解等轴视图,其示出在堆叠中的远侧缝钉下方缩回的砧座和夹具;
图68为沿缝合器纵向轴线截取的远侧缝合器端部的侧视剖视图,其示出与图67相同的部署阶段;
图69为远侧缝合器端部的侧视分解局部剖视图,其示出与图67相同的部署阶段;
图70为远侧缝合器端部的俯视局部剖视图,其示出与图67相同的部署阶段;
图71为内窥镜-腹腔镜混合手术期间的患者示意图;
图72为砧座的等轴视图,其示出额外的任选的缝钉弹射构件;
图73为远侧砧座端部的俯视图,其示出任选的缝钉弹射构件;
图74为缝合器的远端的局部剖视的等轴视图,其示出处于初始部署位置中的可供选择的缝合器实施例;
图75为远侧缝合器端部的侧视局部剖视图,与图74类似,其示出在部署序列开始时通过垫座堆积到排出通道中的缝钉;
图76为示出处于初始未部署状态的示例性缝钉的俯视图,该缝钉用于从图74和75的可供选择的缝合器实施例进行部署;
图77为图74和75所示扩张器的等轴视图;
图78为可供选择的形成器本体的等轴视图;
图79为图78所示的形成器本体的局部剖视的等轴视图;
图80为用于图78和79的形成器本体的插入部件的等轴视图;
图81为用于图74所示实施例的远侧缝合器端部的局部剖视的等轴视图;
图82为缝钉分度器的可供选择的实施例的等轴视图;
图83为图74的缝合器的局部剖视的等轴视图,其示出扩张器前进以在部署序列期间靠着砧座尖齿保持缝钉;
图84为远侧缝合器端部的侧视局部剖视图,其示出与图83相同的部署阶段;
图85为图74的缝合器的局部剖视的等轴视图,其示出扩张器前进以在缝合器外侧靠着砧座尖齿保持缝钉;
图86为远侧缝合器端部的侧视局部剖视图,其示出与图85相同的部署阶段;
图87为图74的缝合器的局部剖视的等轴视图,其示出扩张器前进以在缝合器外侧张开缝钉;
图88为远侧缝合器端部的侧视局部剖视图,其示出与图87相同的部署阶段;
图89为图76的缝钉的俯视图,其示出处于中间完全打开状态的缝钉;
图90为图74的缝合器的局部剖视的等轴视图,其示出形成器前进以闭合缝钉;
图91为远侧缝合器端部的侧视局部剖视图,其示出与图90相同的部署阶段;
图92为图76的缝钉的俯视图,其示出处于最终闭合状态的缝钉;
图93为图74的缝合器的局部剖视的等轴视图,其示出形成器从闭合的缝钉缩回;
图94为远侧缝合器端部的侧视局部剖视图,其示出与图93相同的部署阶段;
图95为图74的缝合器的局部剖视的等轴视图,其示出从闭合的缝钉缩回的扩张器以及准备好释放缝钉的砧座尖齿;
图96为远侧缝合器端部的侧视局部剖视图,其示出与图95相同的部署阶段;
图97为图74的缝合器的局部剖视的等轴视图,其示出扩张器和砧座在缝钉释放之后处于部分缩回位置中;
图98为远侧缝合器端部的侧视局部剖视图,其示出与图97相同的部署阶段;
图99为图74的缝合器的局部剖视的等轴视图,其示出扩张器在缝钉堆叠下方缩回,以允许下一个缝钉堆积到砧座尖齿上方;
图100为远侧缝合器端部的侧视局部剖视图,其示出与图99相同的部署阶段;
图101为缝合器的另一个可供选择的实施例的俯视局部视图,其示出处于初始部署状态的缝钉和扩张器;
图102为图101的可供选择的缝合器实施例的俯视局部视图,其示出扩张器向远侧前进以打开缝钉;
图103为图101的可供选择的缝合器实施例的俯视局部视图,其示出处于闭合状态的缝钉;
图104为示出处于初始未部署状态的可供选择的缝合器实施例的俯视图;
图105为缝合器的远端的局部等轴视图,其示出另一个可供选择的缝合器实施例,其中缝钉在砧座尖齿上方,夹具在打开之前接合缝钉背跨距部;
图106为图105所示的可供选择的缝合器实施例和部署阶段的局部俯视图;
图107为图104的可供选择的缝钉的俯视图,其示出处于部分打开状态的缝钉;
图108为图105的缝合器的局部等轴视图,其示出扩张器在砧座尖齿之间前进以部分地打开缝钉;
图109为图108所示的可供选择的缝合器实施例和部署阶段的局部俯视图;
图110为图104的可供选择的缝钉的俯视图,其示出处于完全打开状态的缝钉;
图111为图105的缝合器的局部等轴视图,其示出夹具靠着砧座尖齿驱动缝钉背跨距部以完全打开缝钉;
图112为图111所示的可供选择的缝合器实施例和部署阶段的局部俯视图;
图113为图104的可供选择的缝钉的俯视图,其示出处于最终闭合状态的缝钉;
图114为图105的缝合器的局部等轴视图,其示出形成器靠着缝钉腿部前进以闭合缝钉;以及
图115为图114所示的可供选择的缝合器实施例和部署阶段的局部俯视图。
具体实施方式
现在参见附图,其中在所有视图中相同的编号表示相同的元件,图1示出处于初始未部署构型的本发明的第一示例性紧固件或缝钉10。如图1所示,缝钉10包括一段线材,该段线材形成为背跨距部12以及与背跨距部的相对两端相交的第一和第二腿部14、16。线材具有圆柱形横截面,但是也可以具有其他形状(例如矩形、椭圆形等),以针对应用提供最佳强度,或者帮助进给缝钉,并且该线材沿着线材的长度可以是均匀的或者可以不是均匀的。腿部14、16以大约90°的角度α与背跨距部12相交并且以基本上平行的方式从背跨距部向前延伸。在其中部署装置包括多个缝钉的实施例中,大致平行的腿部能够滑动穿过具有均匀矩形横截面的通道,同时严格保持其定向,从而允许在不卡住的情况下可重复击发该装置。在一个实施例中,角度α被选择成大于90°,以通过增大系统中的摩擦以消除不期望的缝钉运动而帮助缝钉的进给。在可供选择的实施例中,角度α被选择成小于90°,以通过减小系统中的摩擦从而使柄部中的力传递要求最小化来帮助缝钉的进给。对于大致平行的腿部来说,腿部14、16不必是直的。缝钉腿部14、16之间的距离描述了缝钉10的初始宽度尺寸wi。缝钉线材可以具有圆柱形横截面或其他形状(例如矩形、椭圆形等)的横截面,以针对应用提供最佳强度,并且横截面形状沿着线材的长度可以是均匀的或者可以不是均匀的。在一个实施例中,圆形线材的区域已经改变成具有平的表面,或者已经将其横截面修改成更加卵形或椭圆形的形状,以便提供用于在上面推动的更加平的表面。这样的表面包括但不限于背跨距部12或端部区段22。
在与背跨距部12相对处,腿部14、16向内弯曲以形成缝钉端部区段20、22。在初始构造(用于进给)中,缝钉可以具有闭合形式的套环形状,其中套环的每一侧都具有形成该形状的一段线材的至少一部分。在套环形状下,可以将两段线材设置在该形状的整个一侧上,以封闭该形状,如端部区段20、22所示。端部区段20、22的尖端成一定角度,以形成用于刺穿组织的锋利尖头26。尖头26可以在端部区段20、22上以任何所需的方式形成,并可以具有复合的特征件,以帮助穿透组织或钩住(如用倒刺钩住等)已被穿透的组织。然而,优选的是尖头26由从端部区段的外边缘向其内边缘向内渐缩的坡面形成。背跨距部12在腿部14、16之间优选地为非线性的。通过在跨距部的中点处设置浅的凹陷部,如编号30所示,或者沿着跨距部的长度在一个或多个点处设置其它类型的线材变形,可以使背跨距部形成为非线性的。非线性的背跨距部有助于在部署期间进给和对准缝钉。本领域技术人员将会认识到,在不脱离本发明的精神的情况下,可以对缝钉10增加其它特征,以帮助进给和对准缝钉。
缝钉腿部14、16在端部区段20、22处弯曲,使腿部中的一个比另一个腿部长至少一个线材直径。一个腿部(即图1中的缝钉腿部14)具有较长的长度使得端部区段20、22能够处于与背跨距部12共同的平面中。延长一个缝钉腿部相对于另一个缝钉腿部的长度使缝钉处于未部署状态时的竖直外形最小化,从而允许将缝钉穿过缝合器内较小的区域进给。处于未部署状态时,端部区段20、22被弯曲成长度小于或等于背跨距部12的长度。通过将由一个腿部和端部区段(如图1中的腿部16和区段22所示)限定的角度改变至小于90°,同时保持端部区段基本上是直的,可以使端部区段20、22的长度形成为相等的。在可供选择的实施例(未示出)中,通过使端部区段22具有弯曲或弯头部分来实现这个目的。这两种构型仍然保持了闭合形状,并且是不对称的形状。此外,端部区段22成角度可以有助于防止缝钉一旦植入组织中就旋转。在另一个可供选择的实施例中,缝钉腿部14、16也可以沿向外的方向略微弯曲或呈弓形,以使得在其最终成形位置中,组织张力通常将使缝钉的背跨距部12与被紧固的组织保持平行。在一些应用中,这可以有利地帮助固定缝钉,并防止腿部从被紧固的组织旋转出来。在不脱离本发明整体范围的情况下,端部区段22还可以基本上平行于端部区段20(并且因此具有较短的长度)。
本专利申请中使用的缝钉优选地为生物相容的、可植入的、并且可以任选地为可吸收的。候选材料的非限制性列表包括:金属(诸如钛及其多种合金)、不锈钢、镍钛诺、镁、和铁;塑料(诸如PEEK、ProleneTM);可吸收材料(诸如PDSTM、VicrylTM、和聚乳酸(PLA));以及这些类型材料的组合。这些紧固件还可以包含随时间推移选择性释放或立即释放的治疗剂,以有助于愈合、防止感染(如三氯生)、减轻溶胀或浮肿等。
图2示出处于第二中间部署状态的缝钉10。在这个中间状态中,缝钉腿部14、16向外弯曲,以在缝钉腿部的远侧尖端之间描述最大宽度wm。在图2中,示出缝钉腿部14、16张开大约180°,从而与初始背跨距部位置基本上侧向对准,其中端部区段20、22向远侧伸出。然而,应当理解,缝钉腿部14、16可以张开至小于或大于180°的角度。通过在腿部和背跨距部12之间的相交处附近向每个缝钉腿部14、16的内侧施加部署力(图1中的箭头32所示),使缝钉腿部14、16向外弯曲。将向外的部署力32施加到缝钉腿部14、16,而背跨距部12保持固定。对固定的缝钉腿部14、16施加力32而将缝钉腿部向外拉,从而张开缝钉。当缝钉腿部14、16向外弯曲时,背跨距部12保持非线性特征。缝钉腿部14、16的向外弯曲在缝钉10中形成放大的开口,该开口优选地处于缝合器外壳的宽度的两倍范围内。
通过向沿着缝钉腿部14、16侧向地间隔开的点施加力,将缝钉10转变为图3所示的第三完全部署形式。这种力的施加由图2中的箭头34所示。应当理解,在从中间向完全部署状态转变过程中的力的施加点不同于在从初始向中间部署状态转变过程中的力的施加点。在部署过程中,单独的力的施加点或弯曲点增加了线材的经受加工硬化的长度,从而增大了缝钉的强度。在最终部署状态下,缝钉腿部14、16被朝向缝钉的中心拉回,其中尖头26再次向内指向并穿过居间组织(未示出),以穿透和保持组织。缝钉10的长度在初始和最终部署状态之间减小,缝钉宽度随之增加,以使得形成的缝钉的最终宽度尺寸Wf(用缝钉腿部14、16之间的距离描述)大于初始宽度尺寸Wi。在部署期间,缝钉10以一系列步骤在初始、中间和最终形成状态之间转变,该一系列步骤可以是基本上同时进行的,但是优选地按顺序执行,以便首先将缝钉打开到图2的中间状态,然后将缝钉腿部14、16中的每一个向后弯曲成图3所示的形成状态。注意,缝钉端部20、22的不对称构造将转变为形成的缝钉中的类似不对称形状,如图3所示。在缝钉转变期间,缝钉背跨距部保持基本上相同的尺寸和形状。图1-3所示的缝钉旨在作为具有基本平行腿部的闭合形式的缝钉的一个非限制性实例。2009年1月26日提交的名称为“A SURGICAL STAPLER FORAPPLYING A LARGE STAPLE THROUGH A SMALL DELIVERY PORTAND A METHOD OF USING THE STAPLER TO SECURE A TISSUE FOLD(用于穿过小递送端口施加大缝钉的手术缝合器和利用该缝合器固定组织褶皱的方法)”的序列号为12/359,351的共同待审的美国专利申请中公开了另外的缝钉设计、施加器、手术应用以及使用方法,该申请以引用方式全文并入本文中。在将序列号为12/359,351的美国专利申请中公开的缝钉设计应用于本发明时,该缝钉设计将优选地包括非线性背跨距部。除了本文公开的缝钉设计之外,预期在不脱离本发明的范围的情况下,还可以设想其它可供选择的缝钉设计并且将其与本发明一起使用。
现在转到图4,其示出用于部署根据本发明的缝钉10的示例性薄型缝合器40。如图4所示,缝合器40包括柄部42,柄部42具有成型为供外科医生抓握的手枪式握把44。致动器组件46可活动地连接到柄部42,柄部42在缝钉部署期间将被拉向手枪式握把44。细长缝钉外壳50从柄部42向远侧延伸。外壳50具有足够的长度(大约18″),以允许在肥胖症患者体内的多个套管针进入部位处能够使用。同样,外壳50的尺寸被形成为允许穿过小(3-5mm)直径套管针,但在不脱离本发明的总体范围的前提下,也可以穿过直径更大的功能装置。下述缝钉部署组件至少部分地设置在外壳50内部,以用于从远侧部署开口52释放缝钉。致动器组件46既有利于缝钉10穿过外壳50前进,又有利于从远侧开口52部署缝钉。或者,可以将单独的致动机构结合到缝合器40中,以用于将缝钉传送到远侧缝合器开口52并在外部将缝钉从缝合器部署到相邻组织中。
在外科手术应用中,缝合器40通过包括一个或多个端口的套管针进行操作(在传统的腹腔镜式手术、单个部位腹腔镜式手术等中)或者在柔性内窥镜式平台上进行操作(在自然孔口、内腔、经腔或单个部位腹腔镜式手术中),以使得部署开口52与待紧固的组织相邻。缝钉外壳50可以相对于柄部42旋转,以改变部署开口52的定向。旋转外壳50的一种方式是借助于旋钮54,该旋钮绕外壳的周围连接。旋钮54包括凸缘56,如图5所示,凸缘56在柄部42的远端处的狭槽内旋转。一个或多个旋钮销58穿过旋钮54而延伸进入或穿过外壳50的壁。随着旋钮54旋转,外壳50继而通过销58与外壳的相互作用而旋转。在旋钮54与外壳50内部的缝钉部署组件之间也存在连接,如以下将更详细地描述,以使得旋钮的旋转也会使缝钉部署组件绕外壳的纵向轴线产生旋转。因此,当外壳50旋转时,缝钉10的腿部相对于周围组织旋转,从而改变部署期间缝钉尖头将刺穿组织的位置。所示缝合器40具有用于开放式外科手术应用或使用套管针的腹腔镜式应用的刚性外壳50。在用于开放式外科手术应用或使用套管针的腹腔镜式应用的可供选择的实施例中,外壳50为大体刚性的,但在不脱离本发明范围的情况下具有至少一个铰接接头,以允许外壳50以受控方式从外壳50的主轴线偏转,从而增加缝合器的可操作范围。在另一个可供选择的构造中,外壳50为大致柔性的,并且具有增加的长度,从而允许通过创伤更小的自然孔口(如经口腔等)进入至需要治疗的患者部位(如在患者的腹膜腔内)。在这些构造的每一者中,可以想到的是,该装置还可以与包括多个端口的单个套管针相容。
图6至9提供了用于缝合器40的示例性缝钉部署组件的多个视图。如这些视图中所示,缝钉部署组件包括缝钉形成器,该缝钉形成器附接到外壳50的远端并且从该远端延伸,以形成和闭合缝钉。在该示例性实施例中,缝钉形成器包括圆柱形本体62和附接的端盖64。如图10A-10C中较详细地示出,形成器本体62包括内部的沿纵向延伸的通道66,该通道66具有台阶式的基本上平行的侧壁。如图8所示,形成器本体侧壁的上部间隔开的距离基本上等于缝钉的初始宽度wi和缝钉腿部直径,以允许未形成的缝钉无阻挡地穿过形成器本体。形成器本体侧壁的下部间隔开的距离基本上等于一对砧座臂164的宽度,以允许砧座臂穿过形成器本体。
沿直径方向相对的调整半径部70从形成器本体62的远端向前伸出。调整半径部70具有向内凹的表面,该表面基本上贴合缝钉线材的外周围。调整半径部70(在图10A-10C中示出了一个)在形成期间冲击缝钉10,从而使背跨距部12和缝钉腿部14、16之间的相交处的外边缘塑性变形。这种变形减小在这些区域内缝钉材料的外部部分中的张力,并有助于减小或消除过度弯曲的必要性,从而有助于消除可能出现的微小裂缝。调整半径部70的半径(S)的一般关系为:S=1.4(WD)+(BR),其中(WD)为线材直径,且(BR)为由砧座几何形状限定的缝钉的内部弯曲半径。如图10C所示,形成器本体62还包括沿着通道66的底部大致在通道的整个宽度中间位置处纵向延伸的凹部72。凹部72容纳砧座分离器,如以下更详细地描述。
回到图7,形成器端盖64连接到形成器本体62的远端,以便与形成器本体和缝钉外壳50同轴地伸出。如图11A-11C中更详细地示出,端盖64包括抵靠形成器本体62的通道66和凹部72的纵向延伸的内通道76和凹部80。端盖通道76的高度从形成器本体通道66的高度减小,以限制能够穿过端盖的缝钉部署部件。端盖64还包括形成到通道76的侧壁中的沿直径方向相对的凹槽82。从图9中可以看出,每个凹槽82的半径基本上与缝钉线材的半径相同,以允许当形成器在部署期间在缝钉上方前进时凹槽与缝钉腿部14、16接合。形成器本体62上的调整半径部70向远侧、向前伸到凹槽82中。端盖64还包括如84所表示的向内弯曲的远侧表面。向内弯曲部84和端盖64的成角度的表面提供暴露的打开的缝钉10的腹腔镜式或内窥镜式的更佳可视性。虽然在本文中将缝钉形成器示出为和描述为由两个分开但接合的部件构成,但是在不脱离本发明的范围的情况下形成器也可以制造成具有所述特征的单个部件。除了对于本领域技术人员而言传统的或者说是标准的制造技术之外,还可以想到的是,一体式形成器将能够很好地适合于金属注模(MIM),金属注模将允许这个部分以合理的价格制成更大的体积。
回到图7,缝钉引导件90在缝钉外壳50内部位于形成器本体62的近侧。缝钉引导件90的外周边的形状被形成为贴合外壳50的内周围。缝钉引导件90在缝钉外壳50内同中心地延伸,并且包括用于接纳旋钮销58的近侧开口92。销58穿过缝钉引导件开口92和缝钉外壳开口60而延伸,以便将引导件和外壳沿侧向固定在一起以进行旋转。将旋钮销58插入到缝钉引导件开口92中将固定缝钉引导件90的纵向位置。如图6和7所示,缝钉外壳开口60为槽形形状,其纵向长度比缝钉引导件开口92和旋钮销58的纵向长度大。外壳狭槽60的较长长度使得缝钉外壳50能够沿着缝合器纵向轴线相对于固定的缝钉引导件90往复运动。当外壳狭槽60相对于固定销58滑动时,缝钉形成器在外壳50的远端处前进和缩回。外壳狭槽60的近端和远端可以起到用于缝钉形成器的前进和缩回的端部阻挡件的作用。
如图7所示,缝钉10的堆叠100在缝钉引导件90下方沿纵向延伸穿过外壳50。在部署之前,缝钉10在堆叠100内传送到缝合器的远端。在堆叠100内,每个缝钉10都定向成使得缝钉的邻接的端部区段20、22定位在最靠近打开的缝合器端部52处。最远侧缝钉的背跨距部12邻接第二缝钉的端部区段20、22,而第二缝钉的背跨距部邻接第三缝钉的端部区段,在堆叠的整个长度上以同样的方式继续。每个缝钉10的腿部14、16都基本上平行地对准,并且可以与缝钉引导件90的壁接触,以保持缝钉的向前定向。堆叠100内可以包括任意数量的缝钉10,其中优选的缝合器实施例能够保持20或更多个缝钉。
缝钉夹具110和夹具延伸部112在缝钉堆叠100下方在与缝钉引导件90相对一侧上延伸。如图12A-12C更详细地示出,缝钉夹具110包括细长条,该细长条具有基本上平的上表面和下表面,其宽度稍稍大于未形成的缝钉10的初始宽度wi。夹具110的远端的形状被形成为与缝钉背跨距部12匹配接合。在图12A-12C中,示出夹具110具有从远端延伸的弓形凸起114。当缝钉准备好(staged)进行部署时,弓形凸起114靠着图1所示的示例性缝钉的径向凹陷部30装配。弓形凸起114与径向凹陷部30匹配,以确保缝钉10的对准(缝钉在夹具100上居中以及平面对准),从而在排出通道的平面中穿过端盖64。另外,夹具110的远端包括由116表示的向内半径,该向内半径基本上等于缝钉背跨距部12的半径。半径116有助于夹具110在部署过程期间接合和保持缝钉10。图12A-12C示出了夹具110上的凹槽116和弓形远侧凸起114,然而,应当理解,远侧夹具表面可以具有其他形状(例如,矩形、椭圆、成角度等)或特征,以便在缝钉部署期间提供夹具和缝钉背跨距部之间的最佳的且稳固的接触。
在各个缝钉掉落到排出通道中以进行部署之前,缝钉堆叠100的远端沿着夹具110的表面驻留。夹具110的近端在相对侧上形成凹口,以形成T形连接器120。通过回到图7可以看到,夹具延伸部112包括有凹口的远端122,T形连接器120插入到该远端122中以将夹具附接到延伸部。在该附接的近侧,夹具延伸部112包括细长条,该细长条具有直立侧边缘,该直立侧边缘在缝钉外壳50内同轴地延伸穿过外壳的近侧打开的端部。夹具延伸部112在条的整个宽度的中点处包括纵向延伸的槽124,该槽124在缝钉堆叠100下方延伸。虽然夹具110和夹具延伸部112示出为通过匹配的T形连接器和凹口进行附接,但是预期在不脱离本发明的精神和范围的情况下,可以采用许多其他的附接方法来连接本发明的夹具和夹具延伸部。
缝钉推动器126沿着夹具延伸部112的表面位于夹具延伸部和缝钉堆叠100之间。夹具延伸部112的直立侧边缘提供用于在夹具延伸部上沿侧向对准缝钉推动器126的框架。缝钉推动器126的近端抵靠夹具延伸部112上的台阶式边缘,以防止缝钉推动器相对于夹具延伸部向近侧运动。缝钉推动器126与夹具延伸部112一起在外壳50内部前进和缩回,以向远侧分度缝钉堆叠100。缝钉推动器126包括一系列沿纵向间隔开的开口,所述开口用编号130表示,连续的开口间隔开的距离大于或最少基本上等于未形成的缝钉10中的缝钉腿部14、16的长度。可以想到的是,连续的开口之间均匀的较大距离将有助于增加装置的可靠性,从而允许部件公差。向远侧延伸的弹簧臂132连接在每个缝钉推动器开口130的近端处,以及连接在缝钉推动器126的远端处。每个弹簧臂132的自由端朝向堆叠100中的缝钉10向上倾斜。在远侧尖端,每个弹簧臂132向下弯曲,基本上与臂的长度垂直,以形成缝钉邻接面。每个缝钉邻接面的下边缘向下延伸到夹具延伸部槽124中。弹簧臂表面抵靠未形成的缝钉10上的最内侧的可能成一定角度的端部区段22,其中每个弹簧臂132与堆叠100中不同的缝钉接触。每个弹簧臂缝钉表面的角度被形成为与缝钉端部区段22的角度重合,以使得弹簧臂和缝钉端部区段抵靠弹簧臂的基本上整个宽度。随着夹具延伸部112向远侧运动,弹簧臂132对缝钉端部区段22施加压力,以便在外壳50内向远侧推动缝钉堆叠100。
缝钉分度器134邻近缝钉堆叠100在与缝钉推动器126相对一侧上沿纵向延伸。缝钉分度器134与缝钉引导件90、夹具110和夹具延伸部112相组合以形成盒状通道,缝钉堆叠100通过该盒状通道进行传送。缝钉分度器134例如通过图7所示的近侧和远侧铆钉销136附接到缝钉引导件90,以将缝钉分度器固定在缝钉部署组件内的静止位置中。在图13A-13D更详细地示出的示例性实施例中,缝钉分度器134包括具有悬置侧边缘的平的本体140。在一个侧边缘中形成有一系列缝钉保持臂142。保持臂142在近端处连接到本体140,同时远端在本体下方延伸并且相对于缝钉分度器本体的纵向轴线是柔性的。在缝钉部署组件内,每个保持臂142向下悬置到堆叠100中的不同缝钉的套环中。在折叠的缝钉10内,保持臂142的远侧尖端接触内折叠的端部区段22,以形成用于缝钉的近端阻挡件。静止的保持臂142和层叠的缝钉10之间的接触将防止缝钉堆叠100在外壳50内向近侧运动,尤其是在缝钉部署之后夹具延伸部112缩回期间。
除了沿着本体140的侧面的保持臂142之外,在缝钉分度器134的远端附近形成有中心保持臂144。中心保持臂144悬置穿过缝钉分度器134中的开口146并且与堆叠100中的最远侧缝钉接触。随着堆叠100向远侧前进,保持臂142、146弯折到层叠的缝钉的闭合套环中以及从该闭合套环中弯折出去,以使得在每次部署之后,堆叠100中的缝钉向远侧被分度一个保持臂。垫座150以柔性的方式在缝钉分度器134的远端处延伸。在部署过程期间,垫座150将各个缝钉10从堆叠100转移到排出通道,如以下将更详细地所述。作为对图13A-13D所示的缝钉分度器134的可供选择的方式,缝钉分度器可以沿着本体的纵向长度形成有一系列开口146。在该可供选择的实施例中,中心保持臂144从分度器本体的中点向下悬置,穿过开口146,并且进入折叠的缝钉10的每个套环中,从而取代图13A-13D所示的侧保持臂142。在不脱离本发明的范围的情况下,可以想到的是,侧保持臂142或中心保持臂144可以作为另外一种选择沿着背跨距部12的一个或多个点接合未形成的缝钉10。还可以想到的是,可将缝钉引导件90和缝钉分度器134制造成单个部件。在优选的实施例中,组合的引导件和分度器由塑料模制而成,其中保持臂被设计成在缝钉10的远侧分度期间变形,同时防止缝钉10的近侧分度。
现在回到图7,砧座本体160在夹具110下方在与缝钉堆叠100相对一侧上纵向地延伸。如图14A-14C更详细地示出,砧座160包括近端处的T形连接器162。在连接器162的远侧,砧座本体160分叉为由间隙分隔开的一对纵向延伸的砧座弹簧臂164。随着臂之间的间隙沿远侧方向减小,砧座臂164具有向内的偏压。砧座臂164在臂间隙的远端处向远侧朝向砧座的纵向中心线向内成一定角度。每个砧座臂164都端接在向上弯曲的缝钉保持尖齿166中。砧座尖齿166基本上垂直于砧座臂164的纵向长度而延伸。每个砧座尖齿166的近侧表面都优选地具有在其中形成的半径,并在外边缘周围被倒圆,并且向远侧朝向砧座的纵向中心线向内成一定角度。在每个砧座尖齿166的近侧表面上形成的半径有助于在部署过程期间将缝钉10牢固地保持在定位上。砧座本体160与夹具110的远侧表面和形成器本体62组合,以形成缝钉部署组件的排出通道。夹具110基本上沿着砧座臂164的表面延伸并且将堆叠100的远端处的缝钉传送到排出通道。夹具110优选地具有小到覆盖砧座臂164所必需的长度。
砧座本体160的近端通过围绕砧座延伸部170上的一对凸起172安装砧座T形连接器162而附接到该延伸部的远端。如图7所示,砧座延伸部170在夹具延伸部112下方从砧座160向近侧延伸穿过外壳50的开口端。砧座延伸部170为沿着延伸部的纵向中心线的用174表示的裂缝,以便容纳砧座分离器180。分离器180在砧座延伸部裂缝174内基本上穿过外壳50的长度而纵向地延伸。如图15A-15C中更详细地示出,分离器180的用182表示的远端具有增大的高度,以便使分离器能够从砧座本体160下方向上延伸到砧座臂164之间的间隙中。分离器远端182包括向内成角度的尖端184,以方便分离器在砧座臂间隙的远端处在砧座臂164之间的运动。分离器180的近端也具有增大的高度并且包括凹口186,该凹口186用于将分离器连接到驱动器,如以下将更详细地描述。在部署过程期间,分离器180前进和缩回,以使分离器尖端184从砧座臂间隙中的位置运动到砧座尖齿166之间的位置。随着分离器尖端184在砧座尖齿166之间前进,分离器抵抗砧座臂164的向内的偏压而将尖齿拉开。扩张的砧座尖齿166向保持在尖齿上的缝钉的缝钉腿部14、16施加向外的力32(图1所示),从而张开缝钉。优选地,分离器远端182具有的宽度足以使砧座尖齿166被拉开足够的距离,以使缝钉腿部14、16向后弯曲至大约180°的角度,如图2所示。
如上所述,垫座150从缝钉分度器134的远端柔性地延伸,以用于将缝钉从堆叠100转移到缝钉排出通道中以进行部署。在每个部署序列期间,垫座150将一个缝钉从盒状通道中的堆叠100分度到排出通道内的准备位置(staging position)中。如图13A-13D所示,垫座150包括一对向下偏压的侧轨道152。侧轨道152间隔开的距离基本上等于预先部署的缝钉10中的缝钉腿部14、16之间的宽度wi。侧轨道152的面向近侧的端部倾斜成方便缝钉在垫座150下方的运动。一旦缝钉处于垫座下方,则侧轨道152就在缝钉腿部14、16上施加向下的力。在图16所示的初始预击发位置中,垫座150刚好在缝钉堆叠100的远侧,并且处于排出通道内已准备好的各个缝钉10上方。在这个位置中,垫座侧轨道152向下推到准备好的缝钉的腿部14、16上,以将缝钉保持在定位上。当垫座150向下推到缝钉10上时,处于初始向内偏压位置中的砧座尖齿166向上延伸穿过缝钉的闭合的套环。图17更详细地示出由砧座尖齿166保持的准备好的缝钉10。
在部署过程期间,夹具110向远侧运动通过排出通道,靠着缝钉10的背跨距部前进,并且将缝钉卡在夹具和砧座尖齿166之间。当夹具110前进时,垫座150的近端通过前进的夹具与侧轨道152的近侧倾斜表面之间的接触抵抗向下的偏压而被向上提升。当夹具110继续前进时,堆叠100中最远侧缝钉在垫座150下方通过运动的堆叠的力而被推动。当缝钉在垫座150下方运动时,垫座侧轨道152将缝钉腿部14、16向下推到夹具110上。在打开和形成前一个缝钉期间,该缝钉保持在这个位置中:位于垫座150和夹具110之间,并且靠着端盖64的近侧表面。当最远侧缝钉在垫座150下方运动时,剩下的缝钉堆叠100由于缝钉推动器126的前进而在盒状通道内通过夹具延伸部112向远侧分度。当在缝钉形成之后夹具110缩回时,垫座150将缝钉向下推到远侧夹具表面和缩回的砧座尖齿166之间的排出通道中,从而将缝钉准备好以用于下一个部署序列。在本发明中,外壳50内的缝钉部署部件的尺寸基本上与预先部署的缝钉10的尺寸相同,以便使缝钉的尺寸最大化,并且由此使部署期间的组织提升最大化,同时保持缝合器的小(3-5mm)的外形。端盖64中的远侧部署开口52的尺寸被形成为允许夹具110、砧座尖齿166、分离器180和部署缝钉10在部署过程期间穿过到形成器外侧,同时端盖的近侧表面起到缝钉堆叠100的端部阻挡件的作用。
现在转到图5、18、19和20,其示出了处于初始部署位置中的缝合器40的近侧柄部端部。柄部42包括以数个部分形成的覆盖件190,这些部分通过本领域已知的多个合适方式中的任何者在制造工艺期间接合在一起。如上所述,旋钮54连接在柄部覆盖件190的远端处,以相对于柄部旋转。缝钉外壳50穿过旋钮54而向近侧延伸并且进入形成器套筒192中。多个凸缘194(图7所示)从外壳50的近端延伸。外壳50通过套筒端部和外壳夹具螺钉196之间的锁定凸缘194固定在形成器套筒192内。形成器远侧阻挡件200和形成器复位弹簧202在套筒和旋钮54之间刚好在形成器套筒192的远侧环绕外壳50。
夹具延伸部112穿过外壳50的打开的近端并且进入夹具套筒204。夹具延伸部112的近端通过连接器206锁定在夹具套筒204内。夹具弹簧212在夹具套筒204和外壳夹具螺钉196之间环绕夹具延伸部112。分离器180和砧座延伸部170穿过夹具套筒204而延伸超出夹具延伸部112的近端。在夹具套筒204的近侧,分离器180中的凹口186接合分离器驱动器214中具有相似尺寸的切口,以用于将分离器附接到驱动器。分离器弹簧216在夹具套筒204和分离器驱动器214之间环绕砧座延伸部170和分离器180,以用于将分离器驱动器偏压到近侧缩回位置。分离器弹簧216相对于柄部42中的其他弹簧具有高的弹簧常数并且能够以部分压缩的预加载构造加载在装置中。该较高的弹簧常数和/或预加载保持分离器弹簧216在夹具110和砧座160已经到达远端阻挡件之前不被压缩。在砧座160和夹具110已经到达最远侧位置之后,分离器弹簧216的压缩允许分离器180继续相对于砧座160和夹具110向远侧运动以扩张砧座尖齿166。砧座延伸部170穿过外壳50的开口端而向近侧延伸,并且超出分离器180和分离器驱动器214,而延伸到柄部42的近端。砧座套筒220通过一个或多个图19所示的连接器222而与砧座延伸部170的近端相邻地附接。砧座阻挡件224通过螺母或其它保持构件226在砧座套筒220的近侧连接到砧座延伸部170。砧座阻挡件224的直径小于砧座套筒220的内径,以允许砧座阻挡件在套筒内运动。砧座弹簧230在砧座阻挡件224和砧座套筒220的远端之间延伸,以用于将砧座阻挡件224偏压到近侧位置。
砧座扣件240位于砧座阻挡件224的下方,以用于在部署过程的一部分期间将砧座160保持在向前位置中。砧座扣件240通过销242而枢转地连接在柄部覆盖件190之间。销242使得砧座扣件240能够在柄部42内向上和向下枢转。砧座扣件弹簧244将砧座扣件240向上偏压至与砧座阻挡件224接触。砧座扣件240的近端延伸出柄部覆盖件190的打开的近端,以允许手动复位该扣件。在图18和20所示的初始部署位置中,砧座阻挡件224处于最近侧位置中,并且砧座扣件240的上表面上的上升尖端248被偏压至与砧座阻挡件的外侧表面接触。在这个位置中,砧座阻挡件224在柄部42内自由运动,其中扣件尖端248沿着阻挡件的外表面行进。
夹具扣件246刚好位于砧座扣件240的远侧,以用于在部署过程期间将夹具110保持在远侧位置中。夹具扣件246通过销250而枢转地连接在柄部覆盖件190之间。销250使得夹具扣件246能够在柄部42内向上和向下枢转。夹具扣件弹簧252沿夹具套筒204的方向偏压夹具扣件246。在图18和20所示的初始部署位置中,夹具扣件246靠着夹具套筒204的外侧表面被向上偏压。砧座扣件240和夹具扣件246均包括沿径向向外延伸的掣子,分别用编号254和256表示。这两个扣件上的掣子254、256朝向彼此延伸到扣件之间的空间中。掣子254、256的尺寸和间距被形成为当砧座扣件240在扣件手动复位之后绕销242枢转时进行接触。在部署过程期间,掣子254、256之间的间距在砧座160的缩回和夹具110的缩回之间产生时间延迟。该时间延迟使得砧座尖齿166能够在缝钉释放之后在夹具110之前缩回,以闭合砧座尖齿和远侧夹具表面之间的间隙。
如图5所示,致动器组件46包括初始分离器触发器260和辅助形成器触发器262。分离器触发器260和形成器触发器262由向近侧开口的通道状的框架构成。分离器触发器260和形成器触发器262的上突出部被倒圆并且向上延伸到柄部覆盖件190中。分离器触发器260的上突出部沿着分离器驱动器214的侧面定位在驱动器的近端和远端之间的开口中。形成器触发器262的上突出部在夹具套筒204的相对侧上延伸,并且在触发器握把朝向手枪式握把44枢转时向近侧与形成器套筒192的近端间隔开,但是与该近端对准而接触。枢转销264、266在柄部覆盖件190的侧面之间延伸,并且独立地穿过分离器触发器260和形成器触发器262,以将致动器组件连接到柄部。分离器触发器260绕销264枢转,同时形成器触发器262绕销266枢转,以便使触发器相对于柄部42独立地旋转。如图18-20所示,枢转销264还延伸穿过分离器片簧270的中间部分,以将弹簧附接到分离器触发器260。分离器片簧270的臂在分离器触发器260的内通道与手枪式握把44之间延伸,以使得弹簧随着分离器触发器被挤压闭合而压缩。第二形成器片簧272绕形成器触发器枢转销266连接。形成器片簧272的臂在形成器触发器262的内通道与分离器触发器260之间延伸。形成器片簧272随着形成器触发器262被挤压闭合而压缩。当触发器上的挤压力释放时,分离器片簧270和形成器片簧272中的压缩力使分离器260和形成器触发器262返回到图18和20所示的初始打开状态。
触发器闩锁274固定在手枪式握把44的端部附近,而棘爪276附接到分离器触发器260的下端部附近。棘爪276通过销278而枢转地附接到分离器触发器260。闩锁274和棘爪276包括分别在连接内侧上的一个或多个齿状物280、288,其在分离器触发器260被拉向手枪式握把44时被牵拉在一起。闩锁上的齿状物280和棘爪上的齿状物288在分离器触发器260到达完全挤压状态时互锁。棘爪弹簧282附接到分离器触发器260内侧,接触棘爪276,以便将棘爪偏压到接合闩锁274的位置中。棘爪276包括向下延伸的尖端284。触发器释放件286附接到形成器触发器262的下端部,以从触发器向近侧向后延伸。触发器释放件286的近端包括指向棘爪尖端284方向的上升的释放件头部290。触发器释放件286在一位置处附接到形成器触发器262,以允许在部署过程期间当形成器触发器枢转通过闩锁的分离器触发器260时使释放件头部290接触棘爪尖端284。棘爪尖端284和释放件头部290成一定角度,以允许在形成器触发器262被挤压闭合时触发器释放件286弯折且在棘爪尖端下方向近侧通过,但是当形成器触发器在挤压力停止之后向后枢转而打开时与棘爪驱动接触。缩回释放件头部290和棘爪尖端284之间的接触使棘爪276抵抗棘爪弹簧282的偏压而绕连接销278旋转。当棘爪276旋转时,棘爪齿状物288从闩锁齿状物280脱离,棘爪与闩锁274分离,从而允许分离器触发器260在分离器片簧270的力的作用下向后枢转到完全打开位置。
为了部署缝钉10,将缝合器40穿过小直径端口或柔性的内窥镜式平台而插入,以到达体腔内部的期望组织区域。在适当的组织位置处,缝合器端部52被设置成邻近将欲缝合的组织或组织褶皱,并且根据需要旋转旋钮54,以定位缝钉尖头26。当缝合器40适当对准时,沿手枪式握把44的方向对分离器触发器260进行手动挤压,以启动缝钉部署。在图18和20所示的初始部署位置中,分离器触发器260的上突出部接触分离器驱动器214的远端,同时形成器触发器262的上突出部与形成器套筒192向近侧间隔开。外壳50和附接的缝钉形成器处于近侧缩回位置中,其中准备好的缝钉10位于形成器本体通道66内,刚好邻近形成器端盖通道76,如图17、21和22所示。垫座150上的侧轨道152向下推到排出通道中的准备好的缝钉上,同时堆叠100中下一个缝钉保持在保持臂144和夹具110的上表面之间。在排出通道内,夹具110处于最近侧位置中,其中远侧夹具表面与准备好的背跨距部12相邻。砧座160缩回到形成器本体62内,砧座尖齿166被向内和向上牵拉穿过准备好的缝钉的套环。分离器180也处于最近侧位置,其中分离器尖端184缩回到砧座臂164之间的间隙内侧。
当扩张器触发器260被挤压以开始部署缝钉时,触发器绕销264枢转,使得触发器上突出部推靠分离器驱动器214,从而使驱动器在柄部42内向远侧运动,如图23和24所示。当分离器驱动器214运动时,驱动器由于驱动器和分离器凹口186之间的分级连接而向远侧推动分离器180。分离器驱动器214的远侧运动还对分离器弹簧216施加力,该分离器弹簧216由于弹簧的刚性特性而将力传递至夹具套筒204的近端,从而向前驱动套筒和附接的夹具延伸部112。坐在夹具延伸部112内的缝钉推动器126也随着分离器触发器260被挤压而向远侧运动;使得推动器臂132朝向远侧缝合器端部52驱动堆叠100中的各个缝钉(图25中仅仅示出了一个)。夹具延伸部112使夹具110在排出通道内向前运动,远侧夹具表面和砧座尖齿166之间的间隙减小,从而靠着砧座尖齿的近侧倒圆表面牵拉准备好的缝钉10,如图25至27所示。当夹具110使缝钉10靠着砧座尖齿166运动时,缝钉背跨距部12容纳在远侧夹具表面的向内半径116内,并且夹具表面上的弓形凸起114接合径向凹陷部30,如图28所示。
在缝钉10通过销连接在夹具110和砧座尖齿166之间时,触发器260作用在分离器驱动器214上的连续的力使分离器180和夹具110进一步向远侧前进;将此前静止的准备好的缝钉10和砧座尖齿166推动穿过形成器通道66和76,并且推出形成器端盖64的远端,如图29-31所示。当向远侧推动砧座160时,在柄部42内部,运动的砧座延伸部170抵抗砧座弹簧230的反作用力在砧座套筒220内向远侧拉动砧座阻挡件224,如图32和33所示。当砧座阻挡件224抵靠砧座套筒220的远端时,砧座套筒和砧座阻挡件之间的接触将防止砧座尖齿166以及排出通道内的夹具110和缝钉堆叠100进一步向远侧运动。在这个位置,夹具110已经将准备好的缝钉10和砧座尖齿166完全推出打开的缝合器端部52,如图34所示。当砧座阻挡件224到达砧座套筒220内部的远端阻挡件时,砧座阻挡件的近端向远侧运动通过砧座扣件240上的尖端248,从而允许扣件在扣件弹簧244的力的作用下向上枢转成与砧座阻挡件的近端接触。砧座扣件尖端248和砧座阻挡件224之间的接触将砧座160保持在前进位置中,其中尖齿166处于打开的缝合器端部52外侧,并且该接触防止砧座在缝钉形成和释放期间向近侧缩回。同样,随着夹具套筒204运动超过夹具扣件246的远端,夹具扣件在夹具扣件弹簧252的力的作用下向上枢转到夹具套筒路径中。
当阻止砧座160和夹具110进一步向远侧运动时,分离器触发器260上继续的挤压将分离器驱动器214在柄部42内进一步向远侧推动。当分离器驱动器214前进时,驱动器迫使分离器弹簧216靠着现在静止的夹具套筒204压缩。在这点之前,由于与系统中其它弹簧相比分离器弹簧具有较高的弹簧常数和/或预加载,所以分离器弹簧216发生很小的变形或不发生变形。分离器触发器260上额外的力使分离器180相对于静止的砧座160、缝钉10和夹具110继续向远侧前进。该额外的运动允许分离器尖端184在砧座臂164的端部之间向远侧运动超过砧座间隙。分离器尖端184的角度,以及砧座臂164的向内的角度,利于臂之间的分离器尖端在形成器的开口端52的外侧运动。在分离器触发器行程期间,分离器端部182运动穿过砧座臂间隙和形成器凹部72、80,而到达打开的缝合器端部52。
当分离器尖端184在砧座臂164之间运动时,臂被驱动而分隔开,使得砧座尖齿166向缝钉腿部14、16施加向外的扩张力。缝钉腿部14、16上的这个向外的扩张力在图1中用箭头32表示。对缝钉腿部14、16的力将缝钉10拉到打开状态。当缝钉10从其初始闭合形式的形状张开时,尖头尖端26从向内交叠的位置向上述打开的扩张位置运动,从而使缝钉的宽度尺寸增加。在介于封闭的折叠缝钉状态和开放的伸展缝钉状态之间的宽度大幅增加使得缝钉能够在利用小直径递送轴的同时获得较大的组织提升。当缝钉尖头26面向基本向前的方向时,缝钉腿部14、16限定了大约180°的角度,并与缝钉背跨距部12对准,如图35-38所示。通过控制砧座臂164的侧向扩张,可以根据需要实现更小的开口角度。这可以例如通过减小分离器尖端184的宽度来实现。
当分离器驱动器214靠着夹具套筒204的近端降至最低时,分离器180到达最远侧位置,从而扩张砧座尖齿166且打开缝钉10,如图39-40所示。当分离器驱动器214降至最低时,触发器260枢转至完全闭合位置,在该完全闭合位置中,棘爪276在触发器闩锁274下方行进。在棘爪276处于闩锁274下方时,棘爪弹簧282向上推压近侧棘爪端部,以接合棘爪齿状物280和闩锁齿状物288。在棘爪276通过齿状物280、288保持靠着闩锁274时,分离器触发器260锁定在完全枢转位置中,以将夹具110、砧座160和打开的缝钉10保持在缝合器端部52外侧。触发器棘爪276与手枪式握把闩锁274的接合在部署过程中提供了暂停,从而允许放松致动器组件上的压力。在这种状态下暂停缝合器40使得外科医生能够相对于周围组织或材料操纵打开的暴露缝钉10,以将尖头26插入在期望的位置处。此前以引用方式并入本申请的序列号为12/359,351的美国专利申请中描述了用于操纵组织的示例性方法。棘爪276靠着闩锁274的运动可产生听觉以及触觉反馈,从而告知外科医生缝钉已张开并且可以插入组织。还通过手枪式握把44和分离器触发器260之间的接触提供额外的触觉反馈。
最多至部署过程中的这一点,缝钉部署组件已经仅仅通过分离器触发器260的挤压而被致动。辅助(形成器)触发器262保持在其初始位置中,从而利用外壳狭槽60的远端处的销58沿着缝合器纵向轴线保持外壳50静止。在张开的缝钉10的尖头26已经插入到期望的组织位置处之后,缝钉形成为通过向形成器触发器262施加挤压压力而穿过组织。形成器触发器262上的压力将触发器突出部推靠着形成器套筒192,从而向前驱动套筒并且压缩形成器复位弹簧202。由于套筒和外壳夹具螺钉196的外壳近端的锁定,所以当形成器套筒192向远侧运动时,外壳50也运动,从而使销58滑动通过外壳狭槽60。外壳50使形成器端盖64向远侧运动,从而靠着张开的缝钉腿部14、16牵拉端盖凹槽82。张开的缝钉通过夹具110和砧座尖齿166而相对于运动的形成器端盖64保持固定。端盖64对张开的缝钉腿部14、16的远侧推力迫使腿部绕固定的砧座尖齿166向前弯曲,从而将弯曲的腿部牵拉到端盖凹槽82中。
应当理解,缝钉腿部14、16响应形成器端盖64的力而弯曲的点与之前用于张开缝钉的弯曲点沿侧向向外间隔开,从而沿形成的缝钉的背跨距部引起附加的加工硬化。附加的加工硬化将增加形成的缝钉的强度。形成器凹槽82的内表面之间的距离略小于张开的砧座尖齿166和缝钉腿部14、16的宽度的组合,以当形成器沿缝钉的外侧边缘行进时在形成器凹槽和缝钉腿部之间形成过盈配合。形成器凹槽82和缝钉腿部14、16之间的过盈配合初始引起缝钉的向内过度弯曲。缝钉在形成过程中的过度弯曲通常将小于10°,但其取决于缝钉的材料特性。当形成器端盖64在缝钉形成之后缩回时,缝钉回弹至闭合的大致矩形的构造,在该构造中缝钉腿部再次大致平行。因此,当缝合器闭合时,介于成形器和缝钉腿部之间的过盈配合会“拉伸”缝钉10,以产生大致矩形的最终形状。在金属形成方面,有多种方法可以在一块金属片中形成90°弯头。“Forming a 90 deg.Bend”,MetalForming Magazine,1991年8月,pp.59-60,和“Fractures in MetalStampings”,MetalForming Magazine,1996年11月,pp.84-85中描述了实例和有益效果,这些文献以引用方式全文并入本文中。可以将该领域的技术以新颖的方式应用于缝钉成形领域。
在最终的闭合形状下,由于沿缝钉长度的弯曲点不同,缝钉的宽度大于此前未部署时的宽度。该缝钉宽度的变化使得缝钉能够在递送过程中具有薄型轮廓,而在穿过组织形成时具有更大的轮廓。当缝钉腿部14、16向前弯曲时,尖头26被向内拉回,从而在尖头之间的范围内抓取到组织或材料上。当尖头26向内运动时,缝钉端部20、22穿过组织行进一段弧线,从而将组织拉入闭合的缝钉中。当尖头26到达向内的优选交叠的位置时,形成器端盖64到达其最远侧位置,在该向内的优选交叠的位置中,缝钉10穿过所夹持的组织。在该最远侧位置处,形成器凹槽82的近端处的调整半径部70冲击缝钉背跨距部12和缝钉腿部14、16之间的弯曲,以使背跨距部和缝钉腿部之间相交处的外边缘塑性变形,如上所述。在柄部42内部,形成器套筒192接触形成器远侧阻挡件200的近端,从而压缩套筒和旋钮54之间的弹簧202,并且防止套筒进一步向远侧前进。作为对形成器套筒192和形成器阻挡件200之间形成的端部阻挡件的可供选择的方式,可以通过销58靠着外壳狭槽60的近端降至最低而实现端部阻挡件。当形成器到达远端阻挡件时,形成器触发器262到达完全枢转位置,如图41-42所示,并且触发器释放件286被拉回,以将释放件头部290定位到棘爪尖端284的近侧。如图43-46所示,在该点处,缝钉10穿过组织(未示出)而完全形成,并且防止了进一步挤压致动组件46。
在形成缝钉10之后,形成器触发器262上的挤压压力被释放,从而允许触发器在形成器片簧272的力的作用下枢转回而打开。当形成器触发器262枢转打开时,触发器上突出部旋转返回,从而允许形成器复位弹簧202在柄部内向近侧推进形成器套筒192。随着形成器套筒192向近侧运动,套筒同样迫使外壳夹具螺钉196返回,从而通过锁定的凸缘194将外壳50向近侧拉回。随着外壳50缩回,销58运动到外壳狭槽60的远端,并且形成器端盖64被拉离形成的缝钉,从而将缝钉从形成器释放,如图47-50所示。随着形成器端盖64向近侧缩回,形成的缝钉10保持锁定在组织(未示出)中,并且在砧座尖齿166和夹具110之间保持在打开的缝合器端部52的外侧。
随着触发器262枢转打开,触发器释放件286在棘爪276下方向远侧旋转,其中释放件头部290使棘爪尖端284行进,如图51-52所示。运动的释放件头部290和棘爪尖端284之间的接触抵抗棘爪弹簧282的力而使棘爪276绕销278枢转,从而向下牵拉棘爪齿状物288并且使得棘爪齿状物288与触发器闩锁274脱开。棘爪齿状物288与闩锁齿状物280脱开使得分离器触发器260从锁定状态释放,从而允许触发器在分离器片簧270的力的作用下枢转返回而打开,如图53-54所示。随着分离器触发器260枢转返回打开,触发器的上突出部沿近侧方向推靠分离器驱动器214。分离器驱动器214上的这个近侧力向近侧拉回驱动器和附接的分离器180。分离器驱动器214在分离器触发器260的力的作用下继续向近侧拉动分离器180,直到分离器缩回到初始部署位置。分离器驱动器214有助于通过张开分离器弹簧216而向近侧运动。随着分离器180向近侧运动,分离器尖端184从砧座尖齿166之间收回,从而允许尖齿向内拉动返回而离开缝钉腿部14、16的侧面,如图55-58所示。在接触棘爪尖端284之后,形成器触发器262继续枢转打开,直到触发器的上边缘旋转至与柄部覆盖件190的倾斜边缘接触,在图59-60中用292表示,从而防止触发器的进一步打开。
分离器驱动器214的近侧运动还释放夹具套筒204,以便在张开的夹具弹簧212的力的作用下向近侧运动。随着夹具套筒204向近侧运动,套筒向近侧拉回附接的夹具延伸部112和夹具110,从而将夹具从形成的缝钉缩回,如图55-58所示。如上所述,缝钉堆叠100沿着夹具110和夹具延伸部112的表面行进。随着夹具110向远侧前进,缝钉堆叠100与夹具一起前进。在缝钉形成之后,夹具110缩回到敞开的缝合器端部52内侧。如上所述,缝钉分度本体140沿着缝钉堆叠100的上表面延伸。分度本体140连接到缝钉引导件90,以便在缝钉部署过程期间保持静止。缝钉分度本体140包括多个保持臂142,该多个保持臂142接合堆叠100中的各个缝钉。随着夹具110在缝钉形成之后缩回,保持臂142的远端推靠各个缝钉12上的最内侧端部22,如图56中294处所示。静止的保持臂140和缝钉10之间的接触防止缝钉堆叠100与夹具110一起缩回,从而将堆叠保持在远侧位置中以用于将下一个缝钉分度到排出通道中。如图53-54所示,缩回夹具套筒204接触夹具扣件246的远端,从而阻止夹具110的近侧运动。夹具扣件246和夹具套筒204之间的接触在部署过程中提供了暂停,以用于将形成的缝钉10从缝合器40释放。
在夹具110和分离器180向近侧缩回之后,如果需要的话,形成的缝钉10可以通过操纵砧座160(经由柄部42)离开缝钉而从缝合器40释放。缝钉弹射构件也可以结合到砧座160中,以用于帮助将形成的缝钉从砧座释放。如图72和73所示,缝钉弹射构件可以包括弹簧296,可以在准备好的缝钉下方在砧座臂164内触及该弹簧。弹簧296被偏压到向外暴露位置中。随着夹具110向远侧移过砧座臂164,以使缝钉10在部署期间前进,夹具将弹簧296向下推到砧座臂内的凹部中,并且离开缝钉。随着夹具110和分离器180在缝钉形成之后缩回,弹簧296上的夹具的向下压力被释放,从而允许弹簧向外弯折成与缝钉背跨距部接触。弹簧296的力大于砧座尖齿(该砧座尖齿在分离器180缩回之后向内折叠)的保持力,从而允许弹射弹簧将缝钉推离砧座。为了防止缝钉10的过早释放,弹射构件的向上的弹簧力小于垫座150的相反的向下的力,以使得垫座能够在部署序列结束时将另一个缝钉沉积到砧座尖齿上,而不需要将缝钉弹射或定位到具有夹具110的平面之外。
在缝钉10释放之后,砧座160和夹具110在缝合器40内通过在砧座扣件240的近侧暴露端部上向下压而缩回。压力施加给砧座扣件240,以克服砧座扣件弹簧244的向上的力。由拇指或其他外力在砧座扣件240上产生的向下的压力使砧座扣件240沿向下的方向绕销242枢转。随着砧座扣件240绕销242枢转,砧座扣件尖端248运动成不与砧座阻挡件224的近端接触,从而允许砧座阻挡件在砧座弹簧230的力的作用下向近侧运动,如图59-60所示。随着砧座阻挡件224向近侧运动,砧座延伸部170和附接的砧座160缩回到形成器端盖64的远端内侧,如图61-64所示。
随着砧座扣件240向下枢转,位于枢转销242的近侧上的砧座掣子254沿着向上的方向朝向夹具扣件掣子256旋转,如图65-66所示。在扣件尖端248已经脱离砧座阻挡件224的近端之后,砧座掣子254接触夹具扣件掣子256。砧座掣子254对夹具掣子256的力使扣件夹具246沿着相反的方向绕夹具扣件销250旋转。随着扣件夹具246旋转,扣件的远端被牵拉成不与夹具套筒204的近端接触,从而使得套筒能够在夹具弹簧212的力的作用下继续向近侧缩回。掣子254、256绕相应的砧座和夹具扣件240、246定位,从而在砧座缩回的开始与夹具缩回的继续之间产生时间延迟。该停留时间允许砧座尖齿166朝向夹具110缩回,以在砧座和夹具一起缩回到形成器本体62中之前闭合砧座尖齿和远侧夹具表面之间的间隙,如图67-70所示。
在夹具套筒204从夹具扣件246释放之后,套筒在夹具弹簧212的力的作用下继续缩回,直到夹具弹簧张开返回到其初始状态,如图65所示。同样,砧座阻挡件224继续向近侧缩回,直到砧座弹簧230返回到初始未压缩状态。砧座160在夹具110之前停止缩回,使得夹具能够在排出通道内缩回超出砧座尖齿166,从而在远侧夹具表面和砧座尖齿之间留下间隙。随着夹具110和砧座尖齿166向近侧运动返回,夹具和砧座尖齿在堆叠100的远端处在缝钉下方通过。随着在夹具110和砧座尖齿166之间形成间隙,垫座150的向下的力将远侧缝钉从堆叠100向下推入排出通道。侧轨道152向下推到缝钉腿部14、16上,以使得缝钉腿部与形成器本体通道66的侧壁、远侧夹具表面和砧座尖齿之间的缝钉背跨距部12以及向上延伸穿过闭合的缝钉套环的砧座尖齿平行。随着缝钉10在排出通道下落到这个准备好的位置中,夹具110结束缩回到其初始部署位置(图18-20所示),从而完成缝合器的复位。在致动器组件46和缝钉部署组件完全复位到其初始部署状态以及新的缝钉在砧座尖齿166上准备好时,缝合器40准备再次击发以部署下一个缝钉。
现在转到图74和75,其示出了缝合器40的可供选择的实施例。在该实施例中,缝合器修改为包括扩张器310,该扩张器310用于在部署序列期间打开缝钉10。扩张器310通过向缝钉背跨距部12施加指向远侧的力而打开缝钉10(图76所示),同时缝钉通过销抵靠砧座尖齿166的近侧表面。扩张器310的力施加到背跨距部12的中间部分,同时背跨距部通过砧座尖齿保持固定在背跨距部和缝钉腿部14、16之间的相交处。抵抗腿部相交处的相对固定力的扩张器310的力将缝钉腿部14、16向外拉,从而张开缝钉,而基本上同时使背跨距部12的中心凹入。扩张器310在缝合器40内具有与前述实施例的夹具110类似的形状和位置,除了远侧扩张器端部312之外,该远侧扩张器端部312向内倾斜至中心尖端,如图77所示。远侧扩张器端部312相对于缝合器的纵向轴线的角度优选地为大约45°,但是较小或较大的角度也可以应用于扩张器端部,以改变打开尺寸、打开速度或者调节缝钉的保持力。扩张器310的远侧倾斜表面包括向内半径,由314表示,以用于匹配缝钉背跨距部的外周围。扩张器310的近端包括T形连接器316,以用于附接到前述实施例中与夹具110相关地描述的延伸部112。延伸部112使扩张器310在排出通道中向远侧前进,以便在部署序列期间使准备好的缝钉的背跨距部变形。
同样在该实施例中,形成器本体62修改为包括中心肋322,如图78和79中更详细地示出,该中心肋322纵向延伸到形成器本体通道66中。随着缝钉被垫座150向下推入排出通道,肋322接触缝钉10,从而随着缝钉在排出通道内准备好而提供对缝钉的远端(即端部区段20、22)的支承。随着砧座、缝钉和扩张器310在部署期间前进穿过形成器本体62,肋322定位成坐落在砧座臂164之间。随着扩张器310推靠缝钉10,缝钉沿着肋322的上表面运动并且在打开的缝合器端部52的外侧运动。
在该实施例中,形成器本体62还修改为包括侧向支架324,以用于在盒状通道内支承最远侧缝钉。如图80中更详细地示出,支架324可以成形到插入部件326中,该插入部件326定位在形成器本体62的凹口330(图78和79所示)中,以使得支架324的上表面与扩张器310的上表面共面。支架324与扩张器310的上缝钉保持表面共面,以便随着扩张器在缝钉堆叠下方前进和缩回而在盒状通道内提供对最远侧准备好的缝钉10的支承。支架324防止盒状通道中最远侧缝钉在扩张器310缩回期间过早地倾斜到排出通道中。支架324使得扩张器310能够向近侧缩回超出缝钉堆叠的远端,同时确保缝钉在排出通道内的正确放置。如图77和81所示,扩张器310的纵向侧被部分地切去,如332表示的,以允许扩张器随着扩张器在部署期间前进和缩回而在支架324之间滑动。虽然支承支架324示出为对形成器本体62的插入部件的一部分,但是应当理解,在不脱离本发明的范围的情况下,插入部件(包括支架)可以形成为具有形成器本体62的一体部件。
图82示出了缝合器40的另一个可能的修改。如该图中所示,缝钉分度器134修改为包括缝钉保持臂142对,其从分度器的相对纵向侧向下扩大。每个保持臂对都接合堆叠100中单独的缝钉,其中臂的远端在端部区段和缝钉腿部之间的相交处附近接触缝钉端部区段。每个保持臂142都可以相对于缝钉分度本体140的平面扭转,以在臂的远端和缝钉套环的内侧之间提供较大的倾斜的接触区域。优选的扭转角度为与分度本体140的平面成大约45°。另外,缝钉分度本体140的中心部分可以具有一段增大的深度以形成间隔件340,如图74和75所示。间隔件340在缝钉堆叠100上方纵向地延伸并且接触堆叠内的缝钉的上表面。当堆叠在盒状通道内分度时,间隔件340和缝钉堆叠100之间的接触抑制了缝钉在堆叠内的相对竖向运动。垫座150可以在中心区域(未示出)中具有开口,以允许砧座尖齿166通过,从而允许垫座150将缝钉更牢固地推靠着砧座臂164和肋322。
为了部署缝钉10,在前述实施例中限定为分离器触发器的初始触发器260被朝向手枪式握把44挤压。挤压力使触发器260绕枢转销264旋转,从而使触发器上突出部对分离器驱动器214施加力,该力又向远侧推夹具套筒204。在该实施例中,套筒204向远侧推夹具延伸部112,使扩张器310在排出通道内前进。随着扩张器310向远侧前进,远侧扩张器端部312处的向内半径314接合准备好的缝钉的外周围并且将缝钉推靠砧座尖齿166的近侧表面,从而将缝钉背跨距部保持固定在扩张器尖端和砧座尖齿之间。随着初始触发器260继续向驱动器214施加力,扩张器310继续推靠缝钉10,从而朝向打开的缝合器端部向前驱动缝钉和砧座尖齿166,如图83和84所示。随着砧座尖齿166和准备好的缝钉10行进穿过远侧缝合器开口,砧座尖齿在缝钉腿部14、16和背跨距部12之间的相交处附近保持向内偏压。在缝钉10通过扩张器310和砧座尖齿166保持在打开的缝合器端部的外侧时,砧座阻挡件224靠着砧座套筒220降至最低,从而停止砧座160的进一步远侧运动。
当砧座160到达其完全远侧位置时,如图85和86所示,缝钉10的背跨距部牢固地保持在扩张器端部312和砧座尖齿166的近侧表面之间。在砧座160到达其远侧阻挡件之后,初始触发器260继续使驱动器214前进,从而使扩张器310相对于固定的砧座尖齿前进。随着扩张器310前进,扩张器尖端312在砧座尖齿166之间运动,从而在缝钉腿部14、16和背跨距部12之间的相交处将尖齿向外推靠着缝钉10的内边缘。前进的扩张器尖端312对砧座尖齿166之间的缝钉背跨距部12中的凹陷部30施加了指向远侧的力。如图87和88所示,扩张器310的指向远侧的力将砧座臂164沿侧向逐出,并且使背跨距部12在砧座尖齿之间变形。扩张器310对固定的背跨距部12的变形力将砧座尖齿166侧向地驱动到缝钉腿部14、16中,从而将缝钉10张开到图89所示的状态。在张开中,缝钉10在沿着基部区段12的两个点处弯曲,其中这两个点与砧座尖齿166的近侧表面相对,处于背跨距部和缝钉腿部14、16之间的相交处的紧内侧。随着缝钉10张开,缝钉腿部14、16靠着扩张器尖端312的远侧倾斜表面弯曲返回。缝钉腿部14、16弯曲打开的角度可以变化,这部分地取决于扩张器远侧尖端312的角度,并且还取决于砧座尖齿166和扩张器310之间相对运动的大小。在缝钉10完全张开且稳定在扩张器310和砧座尖齿166时,缝钉可以被缝合器40向前推动,以刺穿或以另外的方式接合预期的组织或其他目标。随着缝钉10张开,初始触发器260枢转到完全闭合位置,其中棘爪276接合闩锁274,以暂停部署过程,从而允许外科医生相对于围绕组织或材料操纵打开的暴露的缝钉10以将尖头26插入在期望位置处。
为了闭合张开的缝钉,挤压形成器触发器262,从而向形成器套筒192施加力,以相对于固定的张开的缝钉10向远侧驱动套筒、外壳50、形成器本体62和形成器端盖64。形成器端盖64的远侧运动将靠着张开的缝钉腿部14、16牵拉端盖凹槽82,如此前的实施例中所述,从而迫使缝钉腿部绕固定的砧座尖齿166向前弯曲以闭合缝钉10,如图90-92所示。在该实施例中,缝钉形成器以与此前所述实施例的类似的方式进行操作以闭合缝钉。在缝钉10闭合之后,形成器触发器262被释放,从而允许形成器套筒将外壳50、形成器本体62和端盖64从缝钉向近侧缩回和牵拉返回,如图93和94所示。随着形成器被向近侧牵拉,缝钉10保持固定在扩张器310和砧座尖齿166之间。随着形成器触发器262枢转打开,触发器释放初始触发器260,如上所述,从而允许触发器上突出部在柄部42内推靠驱动器214并且从缝钉10向近侧牵拉返回扩张器310。图95和96示出了缩回在形成器本体62内的扩张器310。当扩张器310缩回时,砧座160保持处于远侧,闭合的缝钉10锁定在组织(未示出)中,并且被砧座尖齿166保持在打开的缝合器端部的外侧。随着扩张器310缩回,砧座臂164向内缩回,从而释放砧座尖齿166对缝钉腿部14、16的压力。随着移除砧座的向外的力,可以通过按照要求操纵砧座160离开缝钉或任选地通过利用如上所述的缝钉弹射构件来从缝合器释放缝钉10。
在缝钉10释放之后,通过以如上所述的方式释放砧座扣件240而向近侧拉回砧座160。随着砧座扣件240被释放,砧座阻挡件224向近侧运动,从而将附接的砧座延伸部170和砧座160靠着扩张器310的表面拉回到形成器本体62内,如图97和98所示。当砧座160缩回时,扩张器310在缝钉堆叠100的远端下方继续缩回。扩张器310缩回到堆叠100中最远侧缝钉近侧的位置,以允许垫座150将最远侧缝钉向下推入排出通道,如图99和100所示。扩张器310比砧座尖齿166向近侧缩回得更远,以在远侧扩张器尖端和砧座尖齿之间提供用于缝钉背跨距部12的间隙。随着最远侧缝钉通过垫座150在扩张器310前方和砧座尖齿166上方堆积在排出通道中,支架324提供对堆叠100中第二缝钉的支承。支架324使得扩张器310能够充分地缩回,以确保最远侧缝钉堆积到排出通道中,而仍然将剩余缝钉堆叠保持在扩张器的表面上的平面中。形成器通道66中的肋322在排出通道中支承堆积的缝钉的远端(即端部区段20、22),以保持缝钉处于与扩张器310的表面平行的水平平面中。利用肋322将缝钉10支承在排出通道中会将缝钉保持在最佳位置中,以在下一个部署序列开始时与远侧扩张器尖端接合。
在该实施例中,初始实施例的夹具和分离器的功能结合到单个扩张器部件中。为了适应这些改变,可以去除柄部中刚性的分离器弹簧216,原因在于在夹具110已经到达远侧阻挡件之后向前驱动分离器180的弹簧功能在该实施例中不是必要的。通过初始触发器260的上突出部与驱动器214的相互作用而向远侧驱动扩张器310,这又向远侧驱动夹具套筒204。夹具套筒204和延伸部112(在该实施例中其连接到扩张器310)之间的连接使得套筒204上的指向远侧的力能够靠着缝钉和砧座向前驱动扩张器。
图101至103示出了缝合器40的另一个可供选择的实施例,其中具有单独的间隔开的砧座臂164的砧座160被替换为单个实心缝钉支承件350,该支承件350具有连续缝钉接合表面。支承件350包括边沿352,该边沿352延伸超出支承件的远端处的表面平面。边沿352具有倒圆的远端,该远端用于接合缝钉10的背跨距部中的凹陷部30。边沿352的半径的尺寸形成为允许扩张器310的远侧尖端前进到边沿的近侧轮廓中,以将缝钉背跨距部锁定在扩张器和边沿之间。在部署序列期间,缝钉10通过垫座或与前述实施例类似的结构(未示出)堆积在缝钉支承件350上,其中边沿352向上延伸穿过缝钉套环,如图101所示。在部署期间,扩张器310靠着缝钉的背跨距部12前进,同时缝钉在背跨距部12和缝钉腿部14、16之间的相交处保持靠着边沿352的端部。随着扩张器310前进,扩张器使缝钉背跨距部12变形到边沿352中,从而迫使打开缝钉腿部14、16,如图102所示。在缝钉10打开之后,形成器外管353和形成器端盖64靠着张开的缝钉腿部前进,与前述实施例一样,以绕边沿352的外近侧边缘闭合缝钉,如图103所示。与前述弹簧296类似的弹射构件可以容纳在支承件350中,以方便将形成的缝钉从边沿352移除。
图104-106示出了缝合器40的另一个可供选择的实施例的第一部署阶段。在该实施例中,缝钉10被重新构造,如图104所示,以包括相对的向内凹陷部354,该凹陷部354在基本线性的背跨距部12和缝钉腿部14、16之间的相交处延伸到缝钉套环中。凹陷部354使得背跨距部12相对于缝钉的其余段形成减小的宽度。如图105和106所示,当重新构造的缝钉10堆积在砧座尖齿166上方时,该宽度减小的背跨距部12配合在被修改的夹具110的凹的远端356中。砧座尖齿166定位在凹陷部354和缝钉腿部14、16、背跨距部12的远侧之间的连接处。凹陷部354将近侧缝钉端部的宽度降低到小于闭合的砧座尖齿166的宽度。在缝钉10堆积在排出通道中之后,夹具110靠着背跨距部12前进,以将缝钉牢固地保持在夹具和砧座尖齿166之间。
随着缝钉10保持固定,分离器180在砧座臂164之间前进,与上述初始实施例中一样,以靠着缝钉腿部14、16的内边缘侧向地逐出砧座尖齿。砧座尖齿166在缝钉套环内部对缝钉腿部14、16的力将缝钉从初始阶段状态稍稍打开(在大约10°的范围内),如图107-109所示。随着分离器180将砧座尖齿166保持间隔开,夹具110靠着缝钉背跨距部12前进。推动较窄宽度的缝钉背跨距部12的夹具110靠着砧座尖齿166的较宽的近侧表面的力在背跨距部和凹陷部354之间的位置处将缝钉10拉开,如图110-112所示。随着缝钉打开,缝钉腿部14、16向近侧弯回,其中凹陷部354与在形成器362的远端表面中形成的凹槽接触。随着打开的缝钉10保持固定在夹具110、扩张砧座尖齿166和形成器362之间,形成器靠着缝钉腿部14、16向远侧前进。随着形成器362前进,形成器使缝钉腿部14、16在缝钉腿部和凹陷部354之间的相交处沿远侧方向弯曲。随着缝钉腿部14、16向前弯曲,端部区段20、22向内运动并且尖头26叠置,从而闭合缝钉,如图113-115所示。随着形成器362向远侧推靠凹陷部354的弯曲处,形成器使得缝钉稍稍向内过度弯曲。缝钉在形成期间的过度弯曲将通常在8-10°的范围内。随着形成器362在缝钉形成之后缩回,缝钉回弹至闭合的大致矩形的构造,在该构造中缝钉腿部大致平行。因此,当缝合器闭合时,成形器和缝钉腿部之间的过盈配合“拉伸”缝钉10,以产生矩形的最终形状。如在该实施例中,修改缝钉10和夹具110降低了从夹具到打开缝钉所需的力的大小。另外,远侧夹具端部靠着固定扩张的砧座尖齿166前进的凹的形状提供了可预知的缝钉10的开口,从而确保每次缝钉部署期间相符的结果,而不需要如前所述的设定弯曲的拐角。在缝钉10闭合之后,形成器362、夹具110和分离器180向近侧缩回,与前述实施例一样,从而允许砧座尖齿166离开缝钉10的内侧表面而向内缩回。在砧座160缩回之后,缝钉可以从缝合器释放,如上所述。
如上所述,缝合器40的多个应用之一是胃减容(GVR)手术。在GVR手术中,例如图71中概略地示出,在胃腔300的壁中形成褶皱。要进行GVR手术,将套管针端口穿过腹壁中的凹口插入。本发明的缝合器40穿过套管针端口(例如,单个端口腹部套管针、包括多个端口的腹部套管针、经阴道的套管针端口等)并且进入腹膜腔。除了缝合器40之外,其他器械可以插入穿过腹壁或其他进入装置,以方便进行手术。在优选的手术中,经由标准切开手段,胃的较大曲率与连接点无关,该连接点例如网膜和短的胃脉管,并且目标褶皱大约为胃的较大曲率。当缝合器40在胃腔的内部时,向致动器组件46施加压力,以将缝钉10推进至缝合器开口端的外部。缝钉腿部14、16在缝合器的外部被张开,以使得尖头26面向胃腔壁。当缝钉腿部14、16打开时,可操纵缝合器40,以用尖头26抓住、刺穿或以其他方式接合胃腔壁302的节段。抓握器或其他组织操纵装置可以有助于组织和其他目标的定位。当缝钉尖头抓到单独的胃腔壁段上时,该段被拉到一起,以将浆膜组织并置在缝钉腿部之间。当胃腔壁段被拉到一起时,组织向内卷入胃腔300中,从而形成褶皱。当组织段被尖头26折叠和保持时,可将额外的压力施加在致动器组件46上,以穿过组织形成缝钉10。当缝钉10被形成器闭合时,尖头26和缝钉端部区段20、22在胃腔壁内拉到一起,以将组织段固定到一起。
在缝钉10穿过组织形成以将褶皱保持就位后,致动器组件46被释放以将缝钉从缝合器弹出。在部署第一缝钉之后,缝合器40优选地沿预期褶皱线运动至胃腔壁上的第二位置。附加的缝钉优选地沿胃腔壁部署,以延伸褶皱的长度。在此前以引用方式并入本申请的序列号为12/359,351的共同转让的美国专利申请中可以找到关于GVR手术的另外的细节和缝合装置(例如本发明的缝钉部署装置)在GVR手术中的使用;以及本发明的缝合装置的其他外科应用。
在这些手术中,折叠的组织可能产生浮肿。如果褶皱没有通过外科医生形成正确的尺寸,那么这种浮肿或褶皱的肿胀可能会暂时堵塞或阻塞胃腔。这种浮肿将在数天的时间内消散。要解决浮肿就需要外科医生产生较小的褶皱,该较小的褶皱在浮肿消退时限制较小。将诸如支架的装置植入褶皱区域允许外科医生产生更加限制性的褶皱,其中支架在存在浮肿时保持开放内腔。在浮肿消退之后,开放内腔保持不需要支架提供的支承。支架可以是永久植入物,但是优选地是可移除的、可消化的或者以其它方式可吸收的。支架还可以设计成在一些降解之后自然地消逝。能够应用的支架的一个实例是PolyflexEsophageal Stent,其可得自马萨诸塞州内蒂克的Boston Scientific Corporation。例如这些的支架在本领域中是已知的并且被设计成保持腔内不闭合。
优选的是,本文所述的发明将在外科手术之前进行处理。首先,获取新的或用过的器械,并根据需要进行清洗。然后可对器械进行消毒。在一种消毒技术中,将器械置于闭合并密封的容器(诸如塑料或TYVEK口袋)中。然后将容器和器械置于可穿透该容器的辐射场中,诸如γ辐射、X射线、环氧乙烷(EtO)气体、或高能电子。辐射将杀死器械上和容器中的细菌。然后可将消毒后的器械保存在消毒容器中。该密封容器将器械保持在无菌状态下,直到在医疗设备中打开该容器。
以引用方式全文或部分地并入本文的任何专利、公布、专利申请或其他公开材料,被认为仅在所并入的材料不与本公开所阐述的现有定义、陈述或其他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。
为了举例说明和描述起见,已经提供了本发明优选实施例的上述具体实施方式。这些具体实施方式并非意图为详尽的或将本发明限定为所公开的具体形式。根据上述教导可以对本发明进行明显的修改或改变。本文所选择和描述的实施例是为了最好地示出本发明的原理及其实际用途,从而允许本领域的普通技术人员能够最好地以多个实施例利用本发明,并且在适合可设想的具体应用的情况下进行各种修改。本文所附的权利要求旨在限定本发明的范围。
Claims (10)
1.一种部署外科紧固件的方法,包括以下步骤:
a.在所述紧固件处于第一形状的同时引导所述紧固件进入到患者体内,所述第一形状包括第一套环,所述第一套环具有背跨距部,所述背跨距部具有初始尺寸和形状;
b.使所述紧固件的端部区段基本上沿着其整个长度远离彼此运动,同时保持所述背跨距部基本上处于其初始尺寸和形状;以及
c.将所述紧固件成形为宽度比所述第一套环的宽度大的第二套环。
2.根据权利要求1所述的方法,其中将所述紧固件成形为宽度比所述第一套环的宽度大的第二套环的步骤还包括保持所述背跨距部基本上处于其初始尺寸和形状的步骤。
3.根据权利要求1所述的方法,其中引导所述紧固件的步骤还包括提供紧固件的步骤,所述紧固件包括:
a.基部和两个腿部,所述腿部从所述基部延伸离开,所述腿部具有远端区段;
b.第一形状,在所述第一形状中所述远端区段朝彼此向内弯曲,以使得所述远端区段邻近并将所述紧固件成形为第一套环;
c.第二形状,在所述第二形状中所述远端区段基本上沿其整个长度彼此间隔开;以及
d.第三形状,在所述第三形状中所述远端区段朝彼此向内弯曲,以使得所述远端区段邻近并将所述紧固件成形为第二套环,所述第二套环的宽度大于所述第一套环的宽度。
4.根据权利要求1所述的方法,其中成形所述紧固件的步骤包括使组织位置靠近,所述组织位置分隔开的距离大于所述紧固件的所述端部区段之间的最大宽度。
5.根据权利要求4所述的方法,还包括通过所述紧固件的所述端部区段运动所述组织位置。
6.根据权利要求4所述的方法,还包括通过利用至少一个额外的组织操纵器运动所述组织位置。
7.一种部署外科紧固件的方法,包括以下步骤:
a.在所述紧固件处于第一形状的同时引导所述紧固件进入到患者胃腔体内,所述第一形状包括第一套环,所述第一套环具有背跨距部,所述背跨距部具有初始尺寸和形状;
b.使所述紧固件的端部区段基本上沿着其整个长度远离彼此运动,同时保持所述背跨距部基本上处于其初始尺寸和形状;以及
c.围绕胃肠组织将所述紧固件成形为宽度比所述第一套环的宽度大的第二套环。
8.根据权利要求7所述的方法,其中围绕胃肠组织成形所述紧固件的步骤包括形成胃组织的褶皱和减小胃容积。
9.根据权利要求7所述的方法,还包括将可植入的材料固定到患者的组织。
10.根据权利要求7所述的方法,还包括将治疗剂经由所述紧固件引入患者体内的步骤。
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US12/608,860 US9713468B2 (en) | 2009-01-26 | 2009-10-29 | Surgical stapler for applying a large staple through a small delivery port and a method of using the stapler to secure a tissue fold |
US12/608,860 | 2009-10-29 | ||
PCT/US2010/053736 WO2011059666A2 (en) | 2009-10-29 | 2010-10-22 | Surgical stapler for applying a large staple through a small delivery port and a method of using the stapler to secure a tissue fold |
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2009
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-
2010
- 2010-10-22 CN CN201080060299XA patent/CN102686169A/zh active Pending
- 2010-10-22 CA CA2778448A patent/CA2778448A1/en not_active Abandoned
- 2010-10-22 BR BR112012010112A patent/BR112012010112A2/pt not_active Application Discontinuation
- 2010-10-22 AU AU2010318524A patent/AU2010318524A1/en not_active Abandoned
- 2010-10-22 RU RU2012122069/14A patent/RU2012122069A/ru unknown
- 2010-10-22 WO PCT/US2010/053736 patent/WO2011059666A2/en active Application Filing
Cited By (4)
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CN108273186A (zh) * | 2017-01-05 | 2018-07-13 | 柯惠Lp公司 | 用于近距离放射治疗额可植入紧固件、施用器和方法 |
CN108273186B (zh) * | 2017-01-05 | 2022-01-11 | 柯惠Lp公司 | 用于近距离放射治疗额可植入紧固件、施用器和方法 |
US11559700B2 (en) | 2017-01-05 | 2023-01-24 | Covidien Lp | Implantable fasteners, applicators, and methods for brachytherapy |
CN115120786A (zh) * | 2022-06-17 | 2022-09-30 | 上海卓阮医疗科技有限公司 | 生物材料在制备限制胃容积产品中的用途 |
Also Published As
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US20100191282A1 (en) | 2010-07-29 |
WO2011059666A2 (en) | 2011-05-19 |
BR112012010112A2 (pt) | 2016-06-07 |
CA2778448A1 (en) | 2011-05-19 |
US9713468B2 (en) | 2017-07-25 |
AU2010318524A1 (en) | 2012-05-10 |
RU2012122069A (ru) | 2013-12-10 |
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