CN106456166A - 外科缝合器 - Google Patents

外科缝合器 Download PDF

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CN106456166A
CN106456166A CN201480079696.XA CN201480079696A CN106456166A CN 106456166 A CN106456166 A CN 106456166A CN 201480079696 A CN201480079696 A CN 201480079696A CN 106456166 A CN106456166 A CN 106456166A
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surgical stapling
pair
screw rod
stapling device
assembly
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CN106456166B (zh
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詹辉
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Nellcor Puritan Bennett LLC
Covidien LP
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B17/115—Staplers for performing anastomosis in a single operation
    • A61B17/1155—Circular staplers comprising a plurality of staples
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B2017/07214—Stapler heads
    • A61B2017/0725—Stapler heads with settable gap between anvil and cartridge, e.g. for different staple heights at different shots
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08—Accessories or related features not otherwise provided for
    • A61B2090/0807—Indication means
    • A61B2090/0811—Indication means for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument

Abstract

提供了一种外科缝合器(10)，其具有可调节的最小组织间隙(G)。外科缝合器(10)包括近端手柄部分(20)、细长的中央主体部分(30)、远端头部部分(40)、钉砧组件(50)和逼近组件(100)。逼近组件(100)包括驱动螺杆(140)、螺杆止动件(150)和螺杆延伸件(160)。通过使用驱动螺杆(140)的第一或第二对开口(145,147)选择性地将螺杆延伸件(160)固定到驱动螺杆(140)上，这样可对可调节的最小组织间隙(140)进行调节。还提供了一种确定外科缝合器(10)的最小组织间隙(G)的方法。

Description

外科缝合器
技术领域
本公开总体涉及一种外科缝合器，更具体而言，涉及一种环形外科缝合器，其包括便于对限定在外科缝合器的钉砧组件和钉仓组件之间的组织间隙进行调节的结构。
背景技术
环形外科缝合器通常用于采用环形吻合术来连接管状组织部分。通常，环形缝合器包括钉砧组件，钉砧组件可相对于缝合器头部部分移动以夹紧组织。当钉砧组件完全逼近时，钉砧组件和缝合器头部部分限定最小组织间隙。由于待连接的组织部分的厚度根据患者和操作步骤而不同，因此，需要提供一种可容易调节最小组织间隙的装置。
发明内容
可容易地调节最小组织间隙的外科缝合器已经得到证实。该装置包括主体部分、设置在主体部分的远端上且支撑多个钉的头部部分、以及包括钉砧的钉砧组件。钉砧以相对于头部部分可在缩回位置和前进位置之间移动的方式被支撑。在缩回位置，钉砧和头部部分限定最小组织间隙。该缝合器还包括延伸通过主体部分和头部部分的逼近组件。逼近组件的远端支撑钉砧组件，可被致动以使钉砧组件相对于头部部分运动。逼近组件包括固定到驱动螺杆上的螺杆延伸件。螺杆延伸件和驱动螺杆适于以至少第一定向和第二定向被固定在一起。在第一定向时，逼近组件具有固定的第一有效长度，在第二定向时，逼近组件具有固定的第二有效长度。固定的第一有效长度大于固定的第二有效长度。在第一定向时，钉砧和头部部分之间限定第一最小组织间隙，在第二定向时，钉砧和头部部分之间限定第二最小组织间隙。
在一些实施例中，驱动螺杆的远端和螺杆延伸件的近端中的至少一个限定第一对开口和第二对开口，第一对开口的中心轴线和第二对开口的中心轴线纵向隔开。第一对开口的中心轴线和第二对开口的中心轴线之间的距离在0.05mm至5mm之间。驱动螺杆的远端和螺杆延伸件的近端中的另一个限定通孔，通孔被配置成可选择性地与第一对开口或第二对开口对准。当螺杆延伸件位于第一位置时，通孔与第一对开口对准，当螺杆延伸件位于第二位置时，通孔与第二对开口对准。第一对开口的中心轴线垂直于第二对开口的中心轴线。
在一些实施例中，螺杆延伸件位于第一位置时，多个钉的尺寸为4.8mm，当螺杆延伸件位于第二位置时，多个钉的尺寸为3.5mm。螺杆延伸件的远端包括限定多个槽的保持部件。所述多个槽之一在螺杆延伸件位于第一位置时被布置在竖直位置。所述多个槽之一在螺杆延伸件位于第二位置时被布置在水平位置。逼近组件还包括联接到驱动螺杆上的致动旋钮，所述致动旋钮能被选择性地致动以使钉砧组件相对于头部部分运动。手柄部分包括固定手柄和击发触发器。
还提供了一种用于确定外科缝合器的最小组织间隙的方法，所述方法包括以下步骤：提供外科缝合器，所述外科缝合器包括钉砧保持器，限定纵向轴线、竖直轴线和水平轴线，所述钉砧保持器的远端上限定多个槽；沿外科缝合器的纵向轴线观察钉砧保持器的远端；和，确认钉砧保持器的远端上的多个槽相对于竖直轴线和水平轴线的定向，其中，所述多个槽相对于竖直轴线和水平轴线位于第一定向时，所述最小组织间隙是第一距离，所述多个槽相对于竖直轴线和水平轴线位于第二定向时，所述最小组织间隙是第二距离。
附图说明
在此参照附图描述了目前公开的外科缝合器的各种实施例。附图如下：
图1是根据本公开的外科缝合器的透视图，图中省去了近端手柄部分的壳体的一半部分；
图2是图1所示的外科缝合器的逼近组件的透视图；
图3是图2中所示的逼近组件的驱动螺杆、止动件和连接销的放大透视图；
图4是图3中所示的驱动螺杆、止动件和连接销的分解图；
图5是驱动螺杆的远端、螺杆延伸件的近端和图2中所示的逼近组件的销的分解图；
图6是图2中所示的细节部分标示区域的放大图；
图6A是驱动螺杆的远端沿图5所示的线6A-6A剖开的截面图；
图7是图2中所示的细节部分标示区域的放大图；
图8A是图2中的逼近组件的远端视图，图中的螺杆延伸件位于第一位置；
图8B是图2中所示的逼近组件的远端视图，图中的螺杆延伸件绕其纵向轴线旋转180°。
图9A是图2中所示的逼近组件位于第二位置时的远端视图；和
图9B是图2中所示的逼近组件的远端视图，图中的螺杆延伸件绕其纵向轴线旋转180°。
具体实施方式
现在将参照附图详细描述目前公开的外科缝合器的实施例，附图中的类似数字标记表示各图中的相同或相应元件。在整个说明书中，术语“近端”表示装置最靠近使用者的部分，术语“远端”表示装置离使用者最远的部分。
图1-9B示出了当前公开的外科缝合器的实施例，其整体用参考数字标记10表示。外科缝合器10包括近端手柄部分20、细长的中央主体部分30和远端头部部分40。可对近端手柄部分20、中央主体部分30和/或远端头部部分40的长度、形状和/或直径进行选择，以适于特定的手术目的或手术治疗。例如，中央主体部分30可弯曲，以便于进入血管腔(未示出)。外科缝合器10还包括可操作地支撑在远端头部部分40的远端处的钉砧组件50，下面将对其进行更详细的描述。
下面将仅对外科缝合器10和钉砧组件50进行一定程度的描述，以满足充分公开本公开的这些方面的需要。为了详细描述示例性外科缝合器和钉砧组件的结构和功能，请参照同一受让人拥有的下列两项专利：发明人为Milliman的美国专利第7,857,187号(“theMilliman’187”)以及发明人为Gresham等的美国专利第6,945,444号(“the Gresham’444”)，这些美国专利的全部内容引入文中作为参考。
参照图1和2，外科缝合器10的近端手柄部分20包括固定手柄22、击发触发器24和致动旋钮110。致动旋钮110与逼近组件100(图2)接合，逼近组件100从近端手柄部分20的固定手柄22的近端延伸，穿过中央主体部分30，到达外科缝合器10的远端头部部分40。逼近组件100的远端支撑靠近远端头部部分40的钉砧组件50。可操作逼近组件100，来相对于外科缝合器10的远端头部部分40在完全逼近位置和完全前进位置之间调节钉砧组件50的位置。如下面更详细所述，逼近组件100的配置决定最小组织间隙“G”，其中，最小组织间隙是逼近组件100完全逼近时，钉砧组件50的钉砧头52和外科缝合器10的远端头部部分40的钉保持元件42之间的距离。
外科缝合器10的逼近组件100包括致动旋钮110、固定到致动旋钮110的可旋转套筒120、固定到套筒120的远端的轴环130、驱动螺杆140、螺杆止动件150和螺杆延伸件160。可旋转套筒120可旋转地接收并且轴向固定在外科缝合器10的近端手柄部分20的固定手柄22内。驱动螺杆140被接收在可旋转套筒120内，被配置成用于在致动旋钮110旋转时相对于可旋转套筒120纵向运动。具体而言，销132或其他接合部件安装在轴环130内，被接收在限定在驱动螺杆140的近端142上的螺旋螺纹141(图2)内。致动旋钮110的旋转引起可旋转套筒120和轴环130旋转。当轴环130旋转时，销132沿驱动螺杆140的螺旋螺纹141的运动引起驱动螺杆140纵向移动穿过轴环130。致动旋钮110沿第一方向的旋转使驱动螺杆140沿远端方向运动，即，使驱动螺杆140相对于轴环130前进，致动旋钮110沿第二方向的运动使驱动螺杆140沿近端方向运动，即，使驱动螺杆140相对于轴环130缩回。
参照图2，螺杆延伸件160的近端162固定到驱动螺杆140的远端144上，使得驱动螺杆140的纵向运动引起螺杆延伸件160相应地纵向运动。如下面将进一步详细所述，在一个实施例中，如图所示，螺杆延伸件160通过销170牢固地固定到驱动螺杆140上。在某替换实施例中，螺杆延伸件160可通过机械紧固件(未示出)、摩擦或卡扣配合、凹凸配置(未示出)或以任何其他合适方式牢固地固定到驱动螺杆140上。
参照图2-4，螺杆止动件150固定在驱动螺杆140的近端142和远端144之间，位于螺旋螺纹141远端。销148被接收在形成在驱动螺杆140上的开口143和螺杆止动件150上的开口153中，以将螺杆止动件150牢固地固定到驱动螺杆140上。对螺杆止动件150进行定位，使其接合形成在手柄部分20内的止动面(未示出)，以限制驱动螺杆140在手柄部分20内的缩回运动。螺杆止动件150接合止动面的位置限定钉砧组件50相对于远端头部部分40的完全逼近位置。为了更详细描述螺杆止动件150的操作，例如请参照专利the Milliman’187。
参照图5和6，在一个实施例中，如图所示，驱动螺杆140的远端144包括相对布置的第一对开口145和相对布置的第二对开口147。尽管示出仅具有两对相对布置的开口，但是，可以预想到驱动螺杆140可限定两对以上相对布置的开口。第一对开口145限定的第一中心轴线“x1”与由第二对相对布置的开口147限定的第二中心轴线“x2”纵向隔开一定距离“d”。在一个实例中，第一对开口145的第一中心轴线“x1”和第二对开口147的第二中心轴线“x2”之间的距离“d”是0.25mm。可选地，第一对开口145的第一中心轴线“x1”和第二对开口147的第二中心轴线“x2”之间的距离“d”可在0.05mm至5mm之间。尽管示出第一中心轴线“x1”和第二中心轴线“x2”相互垂直，但是可以预想到，第一中心轴线“x1”和第二中心轴线“x2”可相对于彼此以任意角度定向或径向偏置。
螺杆延伸件160的近端162限定通孔161，通孔161在第一定向时定位成与形成在驱动螺杆140的远端144上的第一对开口145对准，在第二定向时定位成与形成在驱动螺杆140的远端144上的第二对开口147对准。通过将销170接收在螺杆延伸件160上的通孔161和第一或第二对开口145、147中的任一对开口中，螺杆延伸件160固定到驱动螺杆140上。在某替换实施例中，螺杆延伸件160可包括第一对开口和第二对开口(未示出)，用于相对于驱动螺杆140上的通孔(未示出)选择性地定向。在又一实施例中，驱动螺杆140和螺杆延伸件160均可包括第一对开口和第二对开口(未示出)，以相对于彼此选择性地定向。以这种方式，螺杆延伸件160可以以四种不同的定向固定到驱动螺杆140上。
通过使用驱动螺杆140的第一对开口145或第二对开口147将螺杆延伸件160选择性地固定到驱动螺杆140上，这样，可将逼近组件的有效长度调节距离d。驱动螺杆140和螺杆延伸件160的有效长度，即，逼近组件的有效长度，影响钉砧组件50在完全缩回时相对于钉仓42的位置，因此，决定外科缝合器10(图1)的最小组织间隙“G”(图1)。
当螺杆延伸件160通过驱动螺杆160上的第一对开口145销接到驱动螺杆140上时，逼近组件100具有固定的第一有效长度，限定在钉砧组件50的钉砧52和外科缝合器10的远端头部部分40的钉仓42之间的最小组织间隙“G”(图1)具有第一距离。当螺钉延伸件160通过驱动螺杆140上的第二对开口147销接到驱动螺杆140上时，逼近组件100具有固定的第二有效长度，最小组织间隙“G”具有第二距离。第一距离和第二距离之差等于第一对开口145的第一轴线“x1”和第二对开口147的第二轴线“x2”之间的距离“d”。在一个实施例中，选择第一距离以适用于钉尺寸为4.8mm的外科缝合器10，选择第二距离以适用于钉尺寸为3.5mm的外科缝合器10。
驱动螺杆140和螺杆延伸件160在组装期间固定在一起。逼近组件的有效长度可在组装外科缝合器10之前选择，因此，外科缝合器10最终的最小组织间隙“G”可在外科缝合器10的组装之前选择。一旦选择了所需的最小组织间隙“G”，螺杆延伸件160的通孔161与驱动螺杆140上的相应的第一对开口145或第二对开口147之一对准，销170可定位通过通孔161和选定的一对开口145或147。如上所述，在一个实施例中，螺杆延伸件160上的通孔161与驱动螺杆140的第一对开口145对准将引起组织间隙“G”(其为0.25mm)大于螺杆延伸件160的通孔161与第二对开口147对准的情况下而产生的组织间隙。以这种方式，仅通过使螺杆延伸件160上的通孔与第一对开口145和第二对开口147中的另一对开口对准，可在外科缝合器10的组装期间调节外科缝合器10的最小组织间隙“G”。因此，调节最小组织间隙“G”不要求对外科缝合器10的现有结构进行改进，不需额外的结构。
参照图7，螺杆延伸件160的远端164包括钉砧保持器166。钉砧保持器166包括多个臂168，它们被配置成选择性地接合钉砧组件50(图1)的钉砧中心杆(未示出)。如图所示，钉砧保持器166包括成环状布置的三个臂168，用于选择性地接收钉砧组件50(图1)的钉砧中心杆(未示出)。臂168之间限定等间距布置的槽167。钉砧保持器166在固定到螺杆延伸件160的远端164上时，钉砧保持器166的槽167的定向可让使用者用肉眼确认是驱动螺钉140上的第一对开口145还是第二对开口147与螺杆延伸件160上的通孔161对准，从而确认外科缝合器10的选定的最小组织间隙“G”，下面将对此进行详细描述。
图8A和8B示出了外科缝合器(图1)的逼近组件100的远端视图，其中，螺杆延伸件160位于第一位置上，即，螺杆延伸件160的通孔161(图6)与驱动螺杆140的第一对开口145(图6)对准。当螺杆延伸件160上的通孔161与第一对开口145对准时，螺杆延伸件160的保持部件166上的槽167之一相对于逼近组件100处于竖直位置上，如图8A和8B中所示的竖直轴线“v”所示。槽167的竖直定位位于保持部件166的底部(图8A)或保持部件166的顶部(图8B)。
图9A和9B示出了外科缝合器10的逼近组件100(图1)的远端视图，其中，螺杆延伸件160位于第二位置上，即，螺杆延伸件160上的通孔161与驱动螺杆140的第二对开口147(图6)对准。当螺杆延伸件160的通孔161与第二对开口147对准时，螺杆延伸件160的保持部件166上的槽167之一相对于逼近组件100处于水平位置上，如图9A和9B中所示的水平轴线“h”所示。槽167的水平定位可在保持部件166的左侧(图9A)或保持部件166右侧(图9B)。
本领域的技术人员将理解到，文中具体所述和附图所示的装置和方法是非限制性的典型实施例。可以预料到，结合一个典型实施例所示或所述的元件和特征可与不违背本公开范围的其他元件和特征相结合。此外，本领域的技术人员将能理解本公开的基于上述实施例的其他特征和优点。因此，本公开并不局限于具体所示和所述的内容，所附的权利要求书所指明的除外。例如，如上所述，角向偏置和纵向隔开的多对开口可设置在螺杆延伸件160和/或驱动螺杆140上，以便于在更大选择范围内对缝合器的最小组织间隙进行调节。另外，通孔161可设置在螺杆延伸件160和/或驱动螺杆140上，可仅部分地延伸通过所述部件。

Claims (13)

1.一种外科缝合器，包括：
主体部分；
头部部分，其设置在主体部分的远端，支撑多个钉；
钉砧组件，其包括钉砧，所述钉砧相对于头部部分被可移动地支撑在缩回位置和前进位置之间，在所述缩回位置中，所述钉砧和头部部分限定最小组织间隙；
逼近组件，其延伸通过主体部分和头部部分，所述逼近组件的远端支撑钉砧组件，并且能被致动以使钉砧组件相对于头部部分运动；所述逼近组件包括固定到驱动螺杆的螺杆延伸件，所述螺杆延伸件和驱动螺杆适于以至少第一定向和第二定向固定在一起；其中，在第一定向，所述逼近组件具有固定的第一有效长度，在第二定向，所述逼近组件具有固定的第二有效长度；其中，固定的第一有效长度大于固定的第二有效长度；其中，在第一定向，钉砧和头部部分之间限定第一最小组织间隙，在第二定向，钉砧和头部部分之间限定第二最小组织间隙。
2.根据权利要求1所述的外科缝合器，其中，驱动螺杆的远端和螺杆延伸件的近端中的至少一个限定第一对开口和第二对开口，第一对开口的中心轴线与第二对开口的中心轴线纵向隔开。
3.根据权利要求2所述的外科缝合器，其中，第一对开口的中心轴线和第二对开口的中心轴线之间的距离在0.05mm至5mm之间。
4.根据权利要求2所述的外科缝合器，其中，驱动螺杆的远端和螺杆延伸件的近端中的另一个限定通孔，所述通孔被配置成可选择性地与第一对开口或第二对开口对准。
5.根据权利要求4所述的外科缝合器，其中，当螺杆延伸件位于第一位置时，通孔与第一对开口对准，当螺杆延伸件位于第二位置时，通孔与第二对开口对准。
6.根据权利要求1所述的外科缝合器，其中，螺杆延伸件位于第一位置时，多个钉的尺寸为4.8mm，当螺杆延伸件位于第二位置时，多个钉的尺寸为3.5mm。
7.根据权利要求2所述的外科缝合器，其中，第一对开口的中心轴线垂直于第二对开口的中心轴线。
8.根据权利要求1所述的外科缝合器，其中，螺杆延伸件的远端包括限定多个槽的保持部件。
9.根据权利要求8所述的外科缝合器，其中，所述多个槽之一在螺杆延伸件位于第一位置时被布置在竖直位置。
10.根据权利要求9所述的外科缝合器，其中，所述多个槽之一在螺杆延伸件位于第二位置时被布置在水平位置。
11.根据权利要求1所述的外科缝合器，其中，逼近组件还包括联接到驱动螺杆的致动旋钮，所述致动旋钮能被选择性地致动以使钉砧组件相对于头部部分运动。
12.根据权利要求1所述的外科缝合器，其中，手柄部分包括固定手柄和击发触发器。
13.一种用于确定外科缝合器的最小组织间隙的方法，所述方法包括：
提供外科缝合器，所述外科缝合器包括钉砧保持器，并且限定纵向轴线、竖直轴线和水平轴线，所述钉砧保持器在远端上限定多个槽；
沿外科缝合器的纵向轴线观察钉砧保持器的远端；和
确认钉砧保持器的远端上的多个槽相对于竖直轴线和水平轴线的定向，其中，当所述多个槽相对于竖直轴线和水平轴线位于第一定向时，所述最小组织间隙是第一距离，当所述多个槽相对于竖直轴线和水平轴线位于第二定向时，所述最小组织间隙是第二距离。
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CA2949253A1 (en) 2015-12-17
CN106456166B (zh) 2019-11-01

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