CN101031246A - 外科缝合器械 - Google Patents

外科缝合器械 Download PDF

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CN101031246A
CN101031246A CNA200480044130XA CN200480044130A CN101031246A CN 101031246 A CN101031246 A CN 101031246A CN A200480044130X A CNA200480044130X A CN A200480044130XA CN 200480044130 A CN200480044130 A CN 200480044130A CN 101031246 A CN101031246 A CN 101031246A
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bin device
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F·比洛蒂
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Ethicon Endo Surgery Inc
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Abstract

一种外科紧固器械，包括钉紧固组件(2)，该钉紧固组件具有弧形仓装置(12)以及与仓装置(12)相对的弧形砧座(8)。仓装置(12)包括至少一排具有第一端和第二端的弧形开口钉排并具有凹面侧和凸面侧。砧座(8)具有钉形成面并适于与仓装置协作形成从仓装置(12)发射的钉的末端。砧座(8)可相对于仓装置(12)运动。容纳在仓装置(12)中并向着砧座(8)运动的刀具有第一侧和与第一侧相对的第二侧，并且被定位在至少一排钉排的凹面侧，刀的第一侧朝向所述钉排。钉紧固组件(2)包括适于在仓装置(12)和砧座(8)之间运动以便将仓装置(12)和砧座(8)对准的止动销(20)，其中止动销(20)设置在弧形钉排的第一端和第二端之间的中间区域中位于刀的第二侧上。

Description

外科缝合器械
技术领域
本发明涉及一种外科缝合器械，其可用于例如所有通过弧形缝合切割术处理的病理诊断和治疗中。
背景技术
所述缝合器械可从WO 01/91646A1中得知。WO 01/91646A1公开了具有设置在缝合器械的远侧区域中的钉紧固组件、轴和从缝合器械的近侧区域中的轴延伸的手柄的外科缝合器械。钉紧固组件包括弧形的仓装置，该仓装置包括多个具有凹面侧和凸面侧的弧形开口钉排。弧形的砧座与仓装置相对设置。砧座具有钉形成面并适于与仓装置协作，以形成从仓装置发出的钉的末端。砧座可相对于仓装置从用于将组织定位在其间的间隔位置相对运动到用于夹钳组织的闭合位置。此外，仓装置中容纳有刀，其定位在至少一排钉的凹面侧上。
在WO 01/91646A1中公开的外科缝合器械可用于切割组织(例如息肉)，并基本上立即止血。在外科手术中，缝合器械被引入例如肛管中并运动到待切除的组织部位。当仓装置和砧座处于隔开或闭合位置时，可通过单独的抓持器械将待切除组织拉到砧座和仓装置之间的区域。之后，使仓装置相对于砧座运动，以便夹钳组织。当仓装置和砧座到达闭合位置时，医生“击发”器械，这意味着钉被驱动离开仓装置，穿刺组织，钉的末端由砧座弯曲，并且刀向着砧座运动以切割组织。当器械回缩时，完全切除的组织保留在钉紧固组件中并由此安全地从患者身体除去。
在WO 01/91646A1中公开的外科缝合器械的具体优点是钉紧固组件的形状，其中仓装置和砧座具有大致弧形横截面形状。这允许对于仓装置和砧座的凹形内表面的畅通无阻的观察及接近。
在由WO 01/91646A1得知的外科缝合器械中，砧座通过从砧座一端开始延伸并大致沿与砧座相对于仓装置的相对运动的方向平行延伸的臂支撑。砧座的另一端不被支撑。因此，在夹钳了待切除组织而受到载荷时，砧座会扭曲，导致钉的端部及砧座的钉形成面的错位。对于设计成经过小直径通道插入的小的外科缝合器械而言，这尤其是问题，因为没有足够空间用于砧座端部处的具有足够尺寸的坚固支撑臂。
为了克服该缺点，已经提出了使用止动销，其不会阻止自由进入砧座和仓装置之间的空间，但在夹钳组织之后所述止动销在仓装置和砧座之间运动以便将仓装置与砧座对准。所述止动销在PCT/EP03/06352中公开。止动销靠近砧座/仓装置的自由端设置。在当待切除组织的长度小于装置的弧形长度的情况下，已知的止动销不会引起不期望地刺穿组织的风险。
但是，可能的是，待切除组织大于装置的弧形长度。在那些情况下缝合器械必须被应用一次以上，用加载的钉仓替换用过的钉仓。目前的在仓装置的自由端具有止动销的缝合器械的问题在于，止动销在由刀长度限定的切割线的外侧留下一个孔。
发明内容
本发明的目的在于提高如通常得自WO 01/91646A1的外科缝合器械的临床优点而不损害其技术性能。
该问题通过具有权利要求1的特征的外科缝合器械解决。本发明的有利方案由从属权利要求限定。
根据本发明的外科缝合器械包括具有弧形仓装置和与仓装置相对的弧形砧座的钉紧固组件。仓装置包括至少一个具有第一末端和第二末端并具有凹面侧和凸面侧的弧形开口钉排。砧座具有钉形成面并适于与仓装置协作形成从仓装置发出的钉的末端。此外，运动装置适于使砧座相对于仓装置基本上以平行关系从用于将组织定位在其间的间隔位置相对运动到用于夹钳组织的闭合位置。钉驱动装置适于驱动钉向着砧座离开仓装置。在仓装置中，包括具有第一侧和与第一侧相对的第二侧的刀。刀定位在至少一排钉的凹面侧上，刀的第一侧朝向所述钉排。刀致动装置适于使刀向着砧座运动。根据本发明，钉紧固组件包括适于在仓装置和砧座之间运动并将仓装置与砧座对准的止动销。止动销设置在刀的第二侧上位于弧形钉排的第一末端和第二末端之间的中间区域。
换言之，止动销没有设置在弧形钉排的近端，但其安放在当刀被致动时止动销运动时可由止动销穿刺的组织将被切除的区域。因此，不存在健康组织或者患者身体中的剩余组织将被止动销损伤的危险。通过下列进一步描述的本发明实施方式的描述，将更好地理解止动销的位置的重要性。
优选地，根据本发明的缝合器械包括轴装置和手柄，钉紧固组件设置在缝合器械的远侧区域并且手柄从缝合器械的近侧区域中的轴装置延伸。在本发明的优选方案中，钉紧固组件可拆卸安装在轴装置的远侧区域中。这样，可包括运动装置、钉驱动装置、刀致动装置和用于使止动销运动的元件的许多元件的轴装置可被设计成单个患者重新加载装置，而钉紧固组件可被设置成单次击发可置换制品，在其钉已经被输送之后可被替换。优选地，止动销的运动可经设置在手柄上的致动元件致动。在优选实施方式中，止动销的运动方向与砧座相对于仓装置的相对运动方向基本上平行。
砧座的钉形成面可以是大致平面的，但其它形状，例如波浪形也可以使用。
在本发明的有利方案中，钉紧固组件适于允许向着仓装置和砧座的凹面内表面畅通无阻地接近。一般得自WO 01/91646A1的所述设计极大地方便了外科手术中缝合器械的控制。
优选地，仓装置和砧座具有大致弧形形状的横截面，弧形大约在10°到350°的角度范围内延伸。
在本发明的优选方案中，砧座通过从砧座的近端开始延伸并沿与砧座相对于仓装置的相对运动的方向平行延伸的臂支撑。这种支撑允许仓装置和砧座之间更大的无障碍区域，但具有刚性比例如使用在仓装置和砧座的中央的支撑臂或者使用一个以上的支撑臂的设计差的一般缺点。但是，该缺点可由止动销的存在来克服，当特别是当仓装置和砧座彼此相向运动以迫使组织压缩到可被缝合穿过的厚度时，并且当钉然后从仓装置被“击发”并由砧座的钉形成面中的沟槽形成时，对准是关键的，在手术步骤过程中仓装置和砧座可通过止动销对准。
优选地，在闭合位置中仓装置和砧座之间的距离是可调节的。例如，运动装置可包括可调止动器以便防止仓装置(或者砧座)运动超过止动位置并防止夹钳过多的组织。或者一系列具有不同内置组织止动器的仓装置可根据组织厚度被使用。还可预期的是使用一系列仓装置，它们具有适于闭合位置中仓装置和砧座之间的所需距离的不同纵向尺寸。通过调节闭合位置中仓装置和砧座之间的距离，器械可与被缝合及切除的组织厚度和类型匹配。
在外科缝合器械的有利方案中，仓装置包括容纳有钉的可置换仓。在该方式中，如果需要，用过的没有钉的仓可被新的仓置换。当器械在相同外科手术期间被多次使用时这特别有益。
上面所公开的一些特征已经从WO 01/91646A1得知，特别是仓装置和砧座的弧形形状以及从砧座的一端开始延伸的支撑臂，这使得例如内窥镜光学外科器械或者额外的外科器械很容易接近外科部位。本发明的止动销允许更精密的外科手术而不涉及损伤不需要以样本形式从患者切除的组织的风险。
这里，术语“钉”以非常一般的意义被使用。它包括金属钉或者夹具，但也包括由合成材料制成的外科紧固件和类似的紧固件。合成紧固件通常具有保持在砧座处的配合件(止动器元件)。在这个意义上，术语“砧座”和“钉形成面”还具有广泛含义，在两部分组成的合成紧固件中包括砧座状工具及其保持止动器元件的表面以及类似装置。
一般而言，根据本发明的缝合器械可被用于在WO 01/91646A1中公开的各种外科手术中，该文献的内容通过引用包含于本申请中。
附图说明
下面，将通过实施方式对本发明进行详细描述，附图显示为：
图1：根据本发明的外科缝合器械的实施方式的钉紧固组件的等轴测图，可动仓装置处于与砧座间隔的位置中，
图2：如图1的等轴测图，仓装置已经向着砧座运动，但没有将组织(未显示)压缩到压缩力可引起仓装置与砧座对准的风险的程度，
图3：如图2的等轴测图，止动销已经运动到砧座处的配合件处以便将装置与砧座对准，准备好将组织最终压缩到所需的尺寸并准备钉的输送(“击发”)，
图4：从不同角度观察的类似于图3的等轴测图，处于已经达到最终组织间隔并且钉已经被输送的时刻，和
图5，仓装置的示意性俯视图，以阴影线示出被吸引到仓装置和砧座之间的空间中的组织，以交叉阴影线示出该由缝合器械切除的组织部分。
具体实施方式
本实施方式的外科缝合器械(以附图标记1表示)具有与在WO01/91646A1中详细描述的外科缝合器械相似的设置。但是，除此之外，所述缝合器械1包括止动销，用于将仓装置与砧座对准(将在下面解释)。
缝合器械1包括安装在轴4的远端上的钉紧固组件2。图1到4仅仅显示了轴的远侧部分。在其近侧区域，轴4与具有用于操作缝合器械1的功能(如本领域公知的那样)的致动元件的手柄连接。用于将致动元件的运动传送到钉紧固组件2的可动部分的力传递元件在轴4内部或者设置在轴4的表面处的通道中受到导引。在本实施方式中，钉紧固组件2被固定在轴4的远端。其中钉紧固组件可拆卸安装的设置也是可以想到的。
钉紧固组件2在其近侧区域中包括钉容纳部分6，和与其相对的远侧区域中的砧座8。钉容纳部分6具有导引可动仓装置12的固定导引部分10。在其一端，砧座8通过从导引部分10沿着纵向延伸、即基本上与轴4的纵向轴线平行的臂14支撑。
仓装置12包括含有至少一排、但(在本实施方式中)优选为四排开口钉排和用于切割组织的刀的仓。其几何形状和相对布置将通过图5在下面详细解释。由于该几何形状，仓装置12和砧座8具有弯曲的弧形形状，如图1到4所示。在该实施方式中，弧形以略小于90°的角度范围延伸。钉紧固组件2的几何形状允许向着仓装置12和砧座8的凹面内表面、即向着可在图1到4中观察到的钉紧固组件2的弧形表面畅通无阻地接近。
砧座8具有带钉形成凹部18的钉形成面16，当外科缝合器械1被“击发”时，所述凹部18用于形成从仓装置12发射的钉的末端，见图1。钉形成凹部18被设置成四个弧形排，以便与钉排的几何形状匹配。
在导引部分10和可动仓装置12的与轴4平行的凹面内表面的中间区域中，止动销20(见图3和4)在安装在钉容纳部分6上的导引元件22中被滑动导引，用于止动销20的致动杆滑动容纳在沿着轴4侧面安装的导引通道24中。止动销20可通过设置在缝合器械1的手柄处的致动元件(在图1中未显示)沿着远端方向运动。止动销20的远端26具有削尖或者逐渐变细的形状，见图4。当止动销20沿着远端方向运动时，其远端26配合在安装在砧座8的凹面内表面上的配合件28中。配合件28具有纵向膛孔，即使由于设计的严格限制而使砧座8稍微相对于仓装置12错位，该膛孔也很容易被削尖或者逐渐变细的远端26找到。当止动销20进一步沿着远端方向突出时，其远端与配合件28中的膛孔对准，从而对准具有钉形成凹部18的仓装置12中的钉的位置。
图1到3显示了外科缝合器械1的操作中的三个步骤。
在图1中，仓装置12处于相对于砧座8的间隔位置，在该状态中，将通过缝合器械1被切除的组织可定位在仓装置12和砧座8之间(也参见图5)。
下一步，仓装置2向着砧座8运动以便将组织轻微夹钳在仓装置12和砧座8之间，见图2。在本实施方式的有利方案中，仓装置12和砧座8之间的最终距离可被调节，以便避免施加在组织上的过多压力。适于使砧座8相对于仓装置12进行相对运动的运动装置的细节对本领域技术人员来说是已知的，也可参见WO 01/91646A1。
在图2中所示的状态下，砧座8可能稍微相对于仓装置12错位，当钉形成时这可引起问题。因此，在图3中(或者图4)显示的下一步，止动销20沿着远端方向运动直到其远端26通过配合件28已经与砧座8对准。在该状态中，缝合器械1可最终闭合并“击发”，也就是说，组织压缩冲程完成，迫使组织形成需要的厚度并且操作用于将钉排出仓装置12的致动元件。
如上所述，钉布置的几何形状、刀和止动销20由图5示出，该图基本上是仓装置12的端面30的示意图。
仓装置12设置有多个设置成同心弧的槽32。每个槽32容纳一个钉，并且使钉削尖的末端朝向端面30。在该实施方式中，有四排钉，即钉排34到37。相邻钉排(钉排34、35以及钉排36、37)的槽彼此相对交错。在钉排35和36之间，图5显示了弧形刀引导件38，即容纳弧形刀的槽。
例如，钉排34具有第一端40、第二端41、凹面(内)侧42和凸面(外)侧34。刀的第一侧44(即，其凸面侧)面对钉排34，而其第二侧45(与第一侧44相对)朝向止动销20。因此，止动销20设置在由所预想的弧形钉排(即钉排34)的第一端40和第二端44之间的中间区域中的刀引导件38容纳的刀的第二侧45上。
图5示出了当患者组织50已经由一些辅助器械吸引到仓装置12和砧座8之间的空间中的状态。在该组织已经被夹钳在仓装置12和砧座8之间后，止动销20被伸出(见前述)。这样，它穿刺组织50。这不会引起对患者的任何伤害，但是，由于立即向后，缝合器械1被“击发”。这意味着，钉被排出，交错的钉排34和35形成几乎立即止血的可靠结构。钉排36和37在组织50的交叉阴影线部分中形成类似结构，从而加固了待切割组织，并对该切割的组织部分止血。之后，刀被立即驱动出刀引导件38，从而切除组织50的交叉阴影线部分。
因此，止动销20造成的组织损伤不会保留在患者体内。
图5还示出了当待切割组织在比刀的弧形长度大的区域上方延伸的情况。其它组织的周边由虚线并用附图标记52表示。当缝合器械1被使用以便切除全部组织区域50、52时，它必须被多次应用，例如在该例子中应用两次，其中在独立的下一次应用之前用加载的钉仓来替代用过的钉仓。然而，止动销20的位置确保了在给定应用期间被止动销20穿刺的组织在相同应用过程中被切除。
在已有器械中，止动销设置在装置的末端，例如在图5中设置在标记为星号54的位置。在这种状况下当缝合器械多次使用时，存在在给定应用中被止动销54穿刺的组织在下一次应用中不被切割的可预期风险，由此对患者体内的组织造成伤害。

Claims (11)

1、一种外科紧固器械，包括：
-钉紧固组件(2)，包括弧形仓装置(12)和弧形砧座(8)，所述弧形仓装置(12)包括至少一排具有第一端(40)和第二端(41)的弧形开口钉排(34、35、36、37)并具有凹面侧(42)和凸面侧(43)，所述弧形砧座(8)与所述仓装置(12)相对，并具有钉形成面(16)且适于与所述仓装置(12)协作形成从所述仓装置(12)发射的钉的末端，
-运动装置，适于使所述砧座(8)相对于所述仓装置(12)基本上以平行关系从用于将组织(50)定位在其间的间隔位置运动到用于夹钳组织(50)的闭合位置，
-钉驱动装置，适于向着所述砧座(8)将所述钉驱动出所述仓装置(12)，
-刀，具有第一侧(44)和与所述第一侧(44)相对的第二侧(45)，所述刀容纳于所述仓装置(12)中并被定位在至少一排钉排(34、35)的所述凹面侧(42)上，所述刀的所述第一侧(44)朝向所述钉排(34、35)，和
一刀致动装置，适于使所述刀向着所述砧座(8)运动，
其特征在于：所述钉紧固组件(2)包括适于在所述仓装置(12)和所述砧座(8)之间运动以便将所述仓装置(12)和所述砧座(8)对准的止动销(20)，其中所述止动销(20)设置在所述弧形钉排(34、35)的所述第一端(40)和所述第二端(41)之间的中间区域中位于所述刀的第二侧(45)上。
2、根据权利要求1所述的缝合器械，其特征在于：还包括轴装置(4)和手柄，所述钉紧固组件(2)被设置在所述缝合器械(1)的远端区域中，并且所述手柄从所述缝合器械(1)的近端区域中的所述轴装置(4)延伸。
3、根据权利要求2所述的缝合器械，其特征在于：所述钉紧固组件可拆卸地安装在所述轴装置的所述远端区域中。
4、根据权利要求2或3所述的缝合器械，其特征在于：所述止动销(20)的运动是可由设置在所述手柄上的致动元件致动的。
5、根据权利要求1-4中任一项所述的缝合器械，其特征在于：所述止动销(20)的运动方向与所述砧座(8)相对于所述仓装置(12)的相对运动方向基本上平行。
6、根据权利要求1-5中任一项所述的缝合器械，其特征在于：所述钉紧固组件(2)能够允许向着所述仓装置(12)和所述砧座(8)的凸面内表面畅通无阻地接近。
7、根据权利要求1-6中任一项所述的缝合器械，其特征在于：所述砧座(8)的所述钉形成面(16)为大致平面。
8、根据权利要求1-7中任一项所述的缝合器械，其特征在于：所述仓装置(12)和所述砧座(8)具有大致弧形的横截面，所述弧形在10°到350°的角度范围内延伸。
9、根据权利要求1-8中任一项所述的缝合器械，其特征在于：所述砧座(8)通过从所述砧座(8)的一端开始延伸并沿与所述砧座(8)相对于所述仓装置(12)的相对运动方向大致平行延伸的臂(14)支撑。
10、根据权利要求1-9中任一项所述的缝合器械，其特征在于：在所述闭合位置中，所述仓装置(12)和所述砧座(8)之间的距离是可调节的。
11、根据权利要求1-10中任一项所述的缝合器械，其特征在于：所述仓装置(12)包括容纳有钉的可置换仓。
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BRPI0419120B1 (pt) 2015-01-13
EP1793742B1 (en) 2008-03-19
BRPI0419120A (pt) 2007-12-11
PT1793742E (pt) 2008-04-18
HK1098939A1 (en) 2007-08-03
JP4607184B2 (ja) 2011-01-05
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CA2583581C (en) 2012-04-24
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US7735704B2 (en) 2010-06-15
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DK1793742T3 (da) 2008-07-21
CN100522076C (zh) 2009-08-05
PL1793742T3 (pl) 2008-10-31
BRPI0419120B8 (pt) 2021-06-22
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JP2008514319A (ja) 2008-05-08
WO2006037352A2 (en) 2006-04-13

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