CN102088916B - 部分可再使用的手术缝合器 - Google Patents
部分可再使用的手术缝合器 Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- 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
- A61B17/07207—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 the staples being applied sequentially
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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
- A61B2017/0023—Surgical instruments, devices or methods, e.g. tourniquets disposable
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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
- A61B17/068—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
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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
- A61B17/068—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
- A61B2017/07285—Stapler heads characterised by its cutter
Abstract
本发明公开了一种部分可再使用的手术缝合器,其用于将缝合钉布署到组织中。所述缝合器具有主体,所述主体具有远端端部、近端端部和它们之间的纵轴。所述近端端部包括手柄,而所述远端端部包括钉仓保持器和与之相对的砧。所述缝合器还具有用于布署所述缝合钉的致动模块。所述致动模块包括用于朝所述砧顺序地发射缝合钉的至少一个可纵向运动的构件。所述致动模块能够容易地从所述主体上移除和更换。所述缝合器主体的组件能被分解、再处理和再装配以备在不同的外科手术中再使用。
Description
技术领域
本发明总体上涉及一种手术缝合器械,更具体地讲,涉及可被分解的手术缝合器,其一些部分可以被再处理和消毒以备在后续外科手术中再使用,并且其包括可拆除的致动模块,所述可拆除的致动模块在单个患者的手术过程中可相对于多个钉仓被再使用。
背景技术
在引入手术缝合器之前,外科医生不得不花费大量时间将患者的组织重新缝合到一起。这曾是外科手术最花费时间的方面。手术缝合器减少了用户将组织重新缝合到一起花费的时间量。这种手术缝合器在以下公布的美国专利中有所描述,这些专利以引用的方式并入本文,所述专利为:Chow等人的US4633861;Chow等人的US4633874;和Schulze等人的US5129570。
与手术缝合器相关的问题为确保在手术过程中所述使用的缝合器是无菌的。可再使用的缝合器通常为相对复杂的机械器械,其难以在使用之后消毒。因此,曾经希望手术缝合器是完全一次性的。由于在一次外科手术中可需要多于一个手术缝合器,基于经济的原因,研发了具有可再装填的钉仓的一次性手术缝合器。这些可再装填的钉仓具有缝合钉以及用于发射缝合钉的发射模块的组合。通常,在发射模块中包含切割器械。因此,每当缝合器被再装填新的钉仓时,也将新的小刀和发射组件插入缝合器中。在单个患者的手术过程中通常使用许多钉仓,导致针对同一患者重复地更换小刀和发射组件。由于小刀在钉仓被用空之后通常没有磨损,因此对同一患者来说,小刀和发射组件可以相对于额外的钉仓被再使用。在对单个患者的手术中再使用发射组件将不需要额外的消毒,并且可降低手术过程中产生的花费。近来,还期望使得手术缝合器的一部分可再使用,从而一部分是一次性的而一部分在后续手术中是可再使用的。缝合器的再使用的部分降低了与外科手术相关的花费,还减少了外科手术的浪费。
因此,为了降低与外科手术相关的花费,需要这样的手术缝合器,所述手术缝合器可以被分解并且所述缝合器的一部分可以被再处理以备后续使用。具体地讲,需要这样一种手术缝合器,其中在单个患者的手术过程中,所述发射和切割组件可以相对于多个钉仓被再使用,从而减少缝合器使用的材料的量。还需要这样一种手术缝合器,其可被容易地装配和分解以允许再处理和再使用一些缝合器部件。另外,需要一种部分可再使用的缝合器,其包括一次性发射模块,以允许更多复杂的切割和缝合组件在外科手术之间被容易地更换。此外,需要一种部分可再使用的手术缝合器,其中可再使用的部件具有简单的单件式设计,以有利于在手术之间有效地再处理这些部件。本发明提供实现这些目标的部分可再使用的手术缝合器。
发明内容
根据本发明,提供了一种用于将缝合钉布署到组织中的部分可再使用的手术缝合器。所述缝合器具有主体,所述主体具有远端端部、近端端部和它们之间的纵轴。所述近端端部包括手柄,而所述远端端部包括钉仓保持器和与之相对的砧。所述缝合器还具有用于布署所述缝合钉的致动模块。所述致动模块包括用于朝所述砧顺序地发射缝合钉的至少一个可纵向运动的构件。所述致动模块能够容易地从所述主体上取下和更换。
在另一实施例中,本发明提供了一种部分可再使用的手术缝合器,其具有带有近端手柄端部和远端砧端部的上夹钳构件。具有近端槽形框架和远端钉仓槽的下夹钳构件与所述上夹钳对齐。具有用于朝所述砧顺序地发射缝合钉的至少一个可纵向运动的构件的致动模块能够容易地从所述下夹钳框架上取下和更换。含有多个缝合钉的钉仓可拆卸地设置在所述钉仓槽中。用于将上夹钳构件和下夹钳构件连接在一起的闩锁构件沿着所述缝合器的纵轴被设置在中间位置。所述闩锁构件相对于所述上夹钳构件和所述下夹钳构件可运动,以将所述缝合器置于一系列不同的锁定状态。所述不同的锁定状态包括装配状态和封闭的闩锁状态,在所述装配状态下,所述闩锁构件被连接至所述夹钳构件和从所述夹钳构件分离,在所述封闭的闩锁状态下,所述闩锁构件锁定到所述夹钳构件。
附图说明
图1是示例性手术缝合器的等轴视图,显示了缝合器处于关闭位置;
图2是缝合器处于打开位置的前视图;
图3是缝合器处于打开位置的等轴视图;
图4是用于缝合器的可再使用的上夹钳构件的等轴底视图;
图5是缝合器上夹钳构件的等轴顶视图;
图6是包括仓槽的可再使用的下夹钳构件的等轴视图;
图7是一次性钉仓的等轴视图;
图8是一次性钉仓的底视图;
图9是可再使用的闩锁构件的等轴视图;
图10是可再使用的闩锁构件的前视图;
图11是闩锁构件的远端端部的详细等轴视图;
图12是缝合器的部分前视图,显示了处于准备装配状态的闩锁构件;
图13是缝合器的部分前视图,显示了处于初始插入状态的闩锁构件;
图14是缝合器的部分前视图,显示了处于旋转和部分闭锁状态的闩锁构件;
图15是缝合器的部分前视图,显示了在预关闭位置时,闩锁构件和上夹钳构件的相对位置;
图16是缝合器的部分前视图,显示了在使用中处于打开位置时,闩锁构件和上夹钳构件的相对位置;
图17是一次性致动模块的等轴视图;
图18是从近端端部向远端端部朝前看时的一次性致动模块的另一等轴视图;
图19是致动模块盘的等轴视图;
图20是致动模块的近端端部的详细等轴视图;
图21是致动模块的顶视图;
图22是致动调节器的等轴视图;
图23是导向块的等轴视图;
图24是推杆的等轴视图;
图25是小刀支撑杆的等轴视图;
图26是致动模块的远端端部的处于关闭状态的等轴视图,显示了保护器顶盖;
图27是致动模块的前视图;
图28是致动模块近端端部的截面图,显示了处于完全返回位置下的致动调节器和止动弹簧之间的关系;
图29是致动模块近端端部的截面图,显示了在发射过程中向前运动的致动调节器。
具体实施方式
现在参照附图,其中在整个附图中类似的数字指示类似的元件,图1至图3显示了本发明的第一示例性手术缝合器20。缝合器20的主体包括上夹钳构件22、下夹钳构件24和闩锁构件30。闩锁构件30相对于上夹钳构件22和下夹钳构件24可枢转,如图2-3所示。闩锁构件30可枢转以经过一系列不同的闩锁状态,从而将缝合器锁定为关闭以使用,或者以不同的角度打开所述缝合器以允许调整位于缝合器中的组织、更换钉仓或者分解所述缝合器。在完成外科手术之后,闩锁构件30可枢转至完全打开位置,以允许缝合器20被分解,以准备消毒和再使用缝合器的一部分。
如图4和图5所示,上夹钳22包括具有通过顶壁36连接的一对相对的侧壁32a、32b的单件形式的细长槽形框架。顶壁36的外表面被合适地成形以形成把手,并且包括有利于外科医生抓握和操作缝合器的上手柄凸起40。上夹钳22的远端端部包括一对向内延伸的凸缘42,其限定了缝合器的砧44。凸缘42通过沿着砧44的整个长度延伸的中心纵向狭槽46分离。每个凸缘42的内表面设置有两个纵行的均匀间隔的缝合钉成形凹坑(staple-forming pocket)50。缝合钉成形凹坑50允许当U形缝合钉在发射过程中朝着砧弹出时成型为B形缝合钉。砧44包括位于最远端端部处的锥形顶端,以有利于将缝合器插入到中空、管状的人体器官中。一对组织阻挡件52在邻近缝合钉成形凹坑50的近端端部处设置在砧44的相对的侧部上。组织阻挡件52与缝合钉成形凹坑50的近端端部横向对齐,以防止组织位于缝合器中砧44以外的位置。在砧44的近端端部处阻挡组织防止未缝合的组织被夹住或切割。
筒销54从组织阻挡件52附近的上夹钳22的相对两侧延伸。销54安装在下夹钳24上的竖直狭槽内,以将上夹钳和下夹钳连接在一起。上夹钳22还包括位于槽侧壁32a、32b的近端端部的一对弯曲的凹口60。如图2所示,凹口60与位于下夹钳24上的凸起62相互作用,以提供在使用过程中容易地对齐所述夹钳的装置。上夹钳22优选地包括单件的生物相容性金属,例如,不锈钢。利用单件形式的材料作为上夹钳22增加了缝合器的结构完整性。或者,上夹钳22可被制造为两件或更多件分离的零件,所述两件或更多件分离的零件在制造工艺中通过公知的连接方法(例如,焊接)连接在一起。
如图6所示,下夹钳24包括单件形式的细长的U形框架,其具有通过底壁66连接的一对侧壁64a、64b。在下夹钳24的远端端部,侧壁64a、64b的尺寸减小,以形成用于将单次使用的钉仓支撑在缝合器中的仓槽70。凹口72设置在邻近仓槽70的远端端部的侧壁64a、64b中。凹口72与钉仓上的侧凸起接合,以将所述仓保持在所述槽内。竖直对齐狭槽56在侧壁64a、64b的上边缘中相对于仓槽70位于近端。如上所述,上夹钳22上的销54与对齐狭槽56接合以将所述夹钳构件对齐和连接在一起。上夹钳侧壁32a、32b之间的宽度稍大于下夹钳侧壁64a、64b之间的宽度,以使得当销54插入到对齐狭槽56中并且凸起62位于凹口60中时,上夹钳被安装为覆盖下夹钳。缺口74形成在侧壁64a、64b的外表面中,相对于对齐狭槽56位于远端。缺口74有利于将致动模块附着到下夹钳构件24,在以下将对此更详细地进行描述。
开口76在沿着下夹钳24的中间位置穿过底壁66形成。侧壁64a、64b在开口76的相对两侧向下延伸以形成位于远端的成角度的凸起80。侧壁64a、64b沿着凸起80的远端边缘成形为形成具有圆形端部88的直边狭槽82。圆形端部88的直径稍大于狭槽82的宽度。在相对于凸起80的近端,侧壁64a、64b的外表面包括闩锁构件定位特征。如图6所示,所述定位特征可包括被机加工到侧壁64a、64b的表面中的多个止动凸耳84或其它表面缺口。图6仅显示了下夹钳24的前侧上的定位特征,但是,应当理解的是,下夹钳的后侧按照相同的方式成型,使得闩锁构件30可通过下夹钳的两侧保持在多个闩锁状态,如以下将描述的。在侧壁64a、64b和底壁66之间的连接处,在下夹钳24的近端端部形成保持特征86。保持特征86可包括侧壁64a、64b的向内伸展部分,其有利于在缝合器20的装配过程中与致动模块进行揿钮连接。
图7和图8显示了用于本发明的缝合器20中的示例性可拆除的钉仓90。仓90适于容纳按照至少两个横向间隔的纵行排列的多个外科手术缝合钉。仓90具有包括相对的侧壁92a、92b的主体,其被构造为可滑动地容纳在下夹钳仓槽70的内部。钉仓90通过从仓的近端端部朝着其远端端部延伸的中心细长狭槽94被纵向分割。通过仓的主体限定的多个缝合钉开口96沿着所述细长中心狭槽94设置。在图示实施例中,缝合钉开口沿着两条横向间隔的交错的行布置,每对行设置在中心纵向狭槽94的相对侧部上。在相邻两行中的缝合钉开口交错排列以提供当器械操作时对组织的更有效的固定。参照图8,钉仓90包括位于细长中心狭槽94的相对两侧上并且设置在交错排列的开口96行之间的一对纵向狭槽100。每个纵向狭槽100从仓90的近端端部朝着远端端部延伸。多个缝合钉驱动器(未示出)可滑动地安装在缝合钉开口96中,以致动装载到钉仓90内的缝合钉。每个缝合钉驱动器被设计为同时致动设置在钉仓90中位于相邻的行中的两个缝合钉。因此第一组缝合钉驱动器被设置为用于致动位于中心纵向狭槽94的一侧上的交错排列的行中的缝合钉,第二组缝合钉驱动器被设置为用于致动位于中心纵向狭槽另一侧上的一对相邻的行中的缝合钉。
钉仓90的远端端部包括有利于下夹钳构件24插入中空的管状身体器官中的锥形顶端。在锥形顶端的近端,钉仓90设置有一对向外延伸的凸起102。一对间隔开的平行的凸缘104从钉仓90的相对两侧向后延伸。腿110在钉仓的近端端部从凸缘104向下延伸。每个腿110设置有圆形的面向下的凹口112。当仓90被装配到下夹钳24上时,凸起102被松弛地容纳在下夹钳侧壁中的凹口72中,腿110延伸穿过在下夹钳底壁66中的开口76。腿的凹口112与闩锁构件30上的销接合,如以下的详细描述,以将仓保持在下夹钳槽70中。在仓90的近端端部,一对翼114从侧壁92a、92b向上和向外延伸。翼114用作允许将钉仓90手动插入下夹钳24和从下夹钳24移除的手指抓握部。通过利用翼114,仓90可被移除到夹钳开口76和凹口72之外,以在使用之后从下夹钳24中移除所述仓。另外,如图3所示,翼114与位于仓槽70的近端端部处的下夹钳侧壁64a、64b接合,以将所述仓锁定在下夹钳24中的一定位置处。短的延伸部分116形成在仓90的后方,并位于向后突出的腿110之间。中心小刀狭槽94纵向延伸穿过延伸部分116,其可在所述狭槽的近端端部的相对侧部上设置有向内倾斜的导向表面。保护销106的一端连接至延伸部分116,并且可以绕着连接点枢转。一开始,当钉仓90被装载到缝合器20中时,保护销106横向延伸越过中心小刀狭槽94。
如上所述,缝合器20包括用于在沿着缝合器的纵向长度的中间位置将上下夹钳构件连接在一起的闩锁构件30。优选地,夹钳构件22、24在邻近砧44和钉仓90的近端端部的位置被连接在一起。在优选实施例中,如图9所示,闩锁构件30包括具有通过顶壁130连接的相对的侧壁124a、124b的单件形式的槽形框架。闩锁构件30还包括用于将闩锁构件枢转地连接至下夹钳24的闩锁销122。优选地,闩锁构件由单件的不锈钢或其它类似的生物相容性金属构成。相对的闩锁构件侧壁124a、124b之间的距离足够大,以跨越下夹钳24的侧壁64a、64b。侧壁124a、124b包括向外延伸的细长的凸缘132,其用作使得闩锁臂120能够在闩锁位置之间手动地枢转的手指抓握部。闩锁臂120的外表面包括手柄延伸部134。当连接至下夹钳构件24时,手柄延伸部134与上夹钳手柄延伸部40结合,以形成便于外科医生操纵缝合器的手抓握部。
闩锁构件30的每个侧壁124a、124b包括朝远端延伸的C形钩构件140,所述钩构件140设置有用于与上夹钳销54接合的向前面对的凹口142。如图9和图10所示,钩构件140包括从钩构件的顶端向后延伸进入凹口142的内凸轮表面144。当闩锁构件30运动至关闭的工作状态时,凹口142与上夹钳销54接合,作为将闩锁构件保持在闩锁状态的偏心闩锁(over-center latch)。在凹口142下方,每个钩构件140朝远端向下突出并超出闩锁构件顶壁130的端部之外。闩锁销122在钩构件140的向下弯的端部之间延伸,如图11所示,横越闩锁构件30的端部。闩锁销122具有圆柱形形状,并且在与每个端部相邻的地方具有平坦表面152。闩锁销122的直径大于下夹钳狭槽82的狭窄开口。通过将闩锁销122插入下夹钳狭槽82中,闩锁构件30可拆卸地连接至下夹钳24。通过将闩锁构件30取向为使得平坦端部152位于与所述狭槽的直边平行,闩锁销122插入到狭槽82中。在这个位置,无论所述销的直径是否大于所述狭槽的宽度,闩锁销122都能插入到狭槽82中。在平坦端部152与狭槽82的直边一致的情况下,闩锁销122插入到狭槽中,如图12所示,直到所述销位于圆形狭槽端部88中为止,如图13所示。
缝合器20还包括用于将所述闩锁构件保持在多个不同的闩锁状态的装置。参照图9和图10,所述保持装置包括从每个闩锁构件侧壁124a、124b的顶部边缘延伸的弹簧臂150。弹簧臂150顺着钩构件140的上部轮廓朝远端向上弯曲,并且包括球状自由端部。在闩锁销122被装配于狭槽82中的情况下,闩锁构件30朝远端成一定角度,如图13所示,缝合器20处于初始的打开状态。为了关闭缝合器20,闩锁构件30朝着缝合器的近端端部旋转,以将闩锁构件拉近下夹钳构件24的主体。随着平坦端部152旋转为不与狭槽82的侧部对齐,销122和狭槽82之间的宽度差别防止销从狭槽端部88中滑出。销122因此固定于狭槽端部88中,从而将闩锁构件30锁定到下夹钳构件24中。
随着闩锁构件30旋转,钩构件140沿着下夹钳构件24的侧部被拉动。随着钩构件140在下夹钳侧壁64a、64b的旁边摆动,弹簧臂150的球形端部接触侧壁上的止动凸耳84。为了使弹簧臂150在止动凸耳84之间运动,将额外的力施加到闩锁构件30以使得弹簧臂朝着钩构件140弯曲,从而弹簧臂的端部可骑在凸耳上。当弹簧臂150位于止动凸耳84之间时,如图14所示,闩锁构件30处于部分锁定状态。在部分锁定状态下,闩锁构件30附着于下夹钳24上,并且对齐狭槽56正好相对于钩构件140的顶端位于远端。上夹钳销54可自由插入下夹钳狭槽56或从下夹钳狭槽56中移出,从而允许上夹钳构件和下夹钳构件分离并重新连接到一起。
随着闩锁销122在狭槽端部88中继续旋转,进一步将闩锁构件30拉近下夹钳构件24,钩构件内凸轮表面144旋转至对齐狭槽56的开口的上方,从而堵塞狭槽并且将上夹钳销54锁定于所述狭槽中。弹簧臂150还沿着止动凸耳84骑于其上,以与顶部凸耳的凹外边缘接合。在这种预关闭状态下,如图15所示,闩锁构件30和上夹钳构件22、下夹钳构件24连接在一起以形成缝合器20的主体,但是上夹钳销54可在狭槽56中在狭槽底部和凸轮表面144之间滑动,从而允许夹钳构件之间的相对运动。闩锁构件30保持夹钳构件处于松弛的闩锁位置,从而允许钉仓和砧之间的相对运动。在夹钳构件22、24的远端端部的相对运动允许在不用将夹钳构件彼此拆开的情况下进行组织调整。
当闩锁构件30旋转至关闭的工作状态(如图1所示)时,闩锁构件包围下夹钳构件24,并且上夹钳构件22上的销54嵌入钩构件凹口142中。弹簧臂150沿着下夹钳构件24的侧部朝远端向上行进至超出止动凸耳84。在这种状态下,上夹钳构件和下夹钳构件锁定在一起,以压缩砧表面和仓表面之间的组织,并且缝合器准备缝合和切割组织。在关闭状态下,在砧表面和仓表面之间通过间隔销160保持最小间隔。为了调整砧表面和仓表面之间的组织的布置,闩锁构件30可旋转返回到预关闭状态,如图16所示,从而将销54从钩构件凹口142中分离。随着闩锁构件30旋转返回,弹簧臂150与止动凸耳84再次接合,以将闩锁构件保持在它的位置上。返回到预关闭状态,钩构件140和销52之间的连接松懈,从而允许销在狭槽56中滑动,而不需要将上夹钳和下夹钳分开。
为了分解缝合器20,闩锁构件30从下夹钳构件24旋转离开,以将上夹钳销54拉出到钩凹口142之外。闩锁构件30可通过拉动弯曲的闩锁臂顶端162从上夹钳22和下夹钳24旋转离开。随着反向旋转力持续施加于闩锁臂120上,弹簧臂150运动经过止动凸耳84,使得钩构件140摆动经过和远离下夹钳侧壁64a、64b。闩锁构件30沿着钉仓90的方向旋转,直至闩锁构件30返回到初始的打开位置,如图13所示。在闩锁构件30位于打开状态下的情况下,闩锁销122上的平坦端部152再次被调整为与狭槽82的直边平行,使得闩锁销能够被抽出狭槽82,从而将闩锁构件从下夹钳构件24上分离。在闩锁构件30被拆卸的情况下,缝合器20可被分解为三个分离的单件式组件,即,上夹钳22、下夹钳24和闩锁构件30。这些可再使用的组件的单件形式的槽形构造为所述组件在两次使用之间提供了容易且彻底的再处理和消毒。
现在看图17和图18,其显示了用于缝合和切割被夹持在上夹钳构件22和下夹钳构件24之间的组织的致动模块170。致动模块170包括U形的纵向的模块盘172,其为致动模块组件提供支撑结构。模块盘172包括通过底壁176连接在一起的一对侧壁174(图19)。模块盘侧壁174之间的距离小于下夹钳侧壁64a、64b之间的距离,以使得模块盘能够可滑动地安装到下夹钳24的近端槽中。如图19和20所示,模块盘170的近端端部包括从侧壁174的外表面突出的一个或多个止动凸耳178。当致动模块170朝近端滑动到下夹钳槽中时,止动凸耳178与下夹钳构件24的内部槽上的保持特征86接合。止动凸耳178与保持特征86的相互作用将致动模块摁住并保持在下夹钳构件24中的它们的位置上。
如图21所示,多个可动致动构件位于模块盘172内,以在盘中相对于上夹钳构件22和下夹钳构件24纵向运动。所述致动构件包括推动器滑块180,其设置在模块盘172中,以在盘中往复纵向运动。推动器滑块180通过侧向凸缘184附着于致动调节器182上。如图3所示,当致动模块170安装在下夹钳24中时,凸缘184延伸穿过形成在下夹钳的侧壁64中的细长导向槽186。凸缘184将调节器182定位在夹钳构件22、24的外部,以允许人工操作调节器。在图3中,调节器182被显示为延伸穿过下夹钳侧壁64b中的导向狭槽186。但是,导向狭槽还可形成在相对的下夹钳侧壁64a中,在这种情况下致动调节器182将延伸到缝合器20的相对侧之外。随着调节器182通过人工沿着夹钳构件22、24的外部运动,凸缘184延伸穿过并骑在导向槽186上。
现在参看图21,致动模块170还包括一对纵向延伸的平行的推杆190。推杆190的近端端部固定在横向间隔的推动器滑块狭槽192内(在图22中显示)以允许推杆与推动器滑块180一起纵向运动通过模块盘172。推杆190从推动器滑块180朝远端延伸,并且可滑动地容纳在形成在导向块200中的纵向狭槽194内,如图23所示。如图18所示,导向块200安装在模块盘172的远端端部。模块盘侧壁174的上边缘向内弯曲超过导向块200的侧边缘,以将导向块保持在模块盘中。另外,凸块202从导向块200的侧部延伸穿过模块盘侧壁174中的开口204,以将导向块固定在所述盘中。导向块200的远端端部延伸到模块盘172的端部之外,并介于钉仓90的后凸缘104之间。导向块200内的侧向狭槽194将推杆190与钉仓90的细长缝合钉驱动器狭槽100对齐。推杆190的远端端部在导向狭槽194的前方延伸,并且设置有楔形顶端206,如图24所示,其限定了用于随着推杆穿过钉仓朝远端运动将缝合钉驱动器接合在仓90内的倾斜凸轮表面。推杆顶端206的纵向运动顺序地驱动缝合钉驱动器通过凸轮作用从仓中发射缝合钉。
参照图23,导向块200包括从属中心部分210,其从下夹钳底壁66中的开口76向下延伸。中心部分210包括在远端形成角度的,具有圆形端部218的直边狭槽212。当缝合器20被装配时,导向块狭槽212与下夹钳侧壁64a、64b中的狭槽82纵向对齐,以使得当闩锁构件30连接至缝合器时闩锁销122能够与下夹钳24和导向块200二者接合。随着闩锁销122穿过狭槽82插入到狭槽端部88中,销还穿过导向块狭槽212,并嵌入在圆形端部218中,将致动模块170和下夹钳24锁定在一起。
如图18和21所示,致动模块170还包括位于推杆190之间的刀支撑杆214。刀支撑杆214和推杆190优选地被制作成金属片组件。刀支撑杆214的近端端部被固定在推动器滑块180(图22)的中心狭槽216中,以将刀支撑杆连接到推动器滑块上,从而通过发射调节器182进行运动。在推动器滑块180的远端,刀支撑杆214可滑动地被容纳在形成在导向块200(在图23中显示)中的中心狭槽220中,以将刀支撑杆与钉仓的细长中心狭槽94对齐。如图25所示,具有斜切割边缘的倾斜刀刃222位于刀支撑杆214的前端。刀刃222的斜切割边缘相对于夹钳构件22、24成一定角度地取向,并且被可滑动地容纳在导向块200的中心纵向狭槽220中。在刀刃222的近端,刀支撑杆214包括仓闭锁凹口228和闭锁切口部分224,其为以下描述的安全保护机构的一部分。刀支撑杆214的近端端部包括由标号226指示的偏移部分。刀偏移部分226通过将刀支撑杆214的靠近近端端部的一部分切除而形成,以制成支撑杆上的两个高点230、232。
如图26和图27所示,保护器顶盖234盖住导向块200的远端端部。顶盖234的中心部分236围绕刀刃222和推杆190的楔形顶端206。向内导向的唇缘240沿着顶盖的底部边缘延伸。在装配期间,向下的压力被施加到保护器顶盖234,以将致动模块的远端端部摁到下夹钳槽中的一定位置。随着顶盖234向下受压,顶盖唇缘240被摁入下夹钳24的外表面上的凹陷74中。
在图19中显示的片簧250被一体化到导向块200下方的模块盘底壁176中。弹簧250通过在发射之后顶着导向块200抬起刀支撑杆切口224而提供安全保护特征,从而防止用空的钉仓的再发射。第二弹簧252在盘的近端端部附近被一体化到模块盘底壁176中。第二弹簧252是止动弹簧,其与推动器滑块180上的凹口相互作用,以防止致动器调节器182在装运过程中向前运动,并且当致动调节器在发射之后回复到模块盘中的最近端位置时提供听觉和触觉反馈。图28和图29更加详细地显示了止动弹簧252的操作。在图28中,弹簧252被显示为与推动器滑块180上的凹口254接合,以防止推动器滑块不经意间朝远端运动。图29显示了通过在致动调节器182上施加不经意的朝远端的力而从凹口254脱离的止动弹簧252。推杆190和刀支撑杆214通过将能够克服弹簧252抵靠凹口254的力的足够的力施加到致动调节器182而向远端前进。在弹簧252从凹口254脱离之后,推动器滑块180可通过模块盘172朝远端滑动,从而首先将推杆190从导向块200推动进入钉仓90,然后将刀支撑杆214从导向块200推动进入钉仓90。
在初始发射位置,如图28所示,在偏移部分226的近端端部点232处,推动器滑块180的向下导向的边缘与刀支撑杆214接触。致动调节器182缩回至导向狭槽186中的完全近端位置,从而将推杆190和刀刃222置于导向块200的狭槽194和220内。当朝远端的推力被施加到致动调节器182上时,弹簧252从凹口254脱离,使得推动器滑块180能够在模块盘172内纵向地前进。随着推动器滑块180运动,滑块使推杆190朝远端前进,导致推杆的倾斜顶端前进进入仓驱动器狭槽100中。在推动器滑块180的初始运动过程中,滑块的远端边缘运动穿过刀支撑杆偏移部分226,如图29所示,从而不与支撑杆本身接触。因此,刀支撑杆214在推杆190和滑块180的初始朝远端运动的过程中保持固定。
在推动器滑块180前进穿过刀偏移部分226之后,滑块的远端边缘接触刀支撑杆214的远端点230。随着调节器182的前进,推动器滑块180和刀支撑杆214之间的接触使得刀支撑杆与推动器滑块和推杆190一起开始朝远端前进。随着刀支撑杆214朝远端运动,刀刃222通过中心狭槽220和后仓延伸部分116导向并且进入钉仓90的中心纵向狭槽94和砧44的中心纵向狭槽46中。随着刀刃222前进通过仓延伸部分116,刀使保护销106偏转至前进的支撑杆的路径之外。刀刃222和推杆顶端206同时前进穿过钉仓90,从而驱动缝合钉穿过开口96并切割组织。刀刃222稍落后于推杆190前进进入钉仓90,这样,在刀刃前进并切割成行的缝合钉之间的组织之前,缝合钉形成到砧和仓之间抓住的组织中。
在刀和推杆通过调节器182完全前进(或前进到期望的向前的位置)时,通过将致动调节器穿过夹钳导向狭槽186朝近端拉回,推动器滑块180缩回至模块盘172中。一开始,推动器滑块180被朝近端拉动,推杆190朝近端拉动,同时刀支撑杆214由于支撑杆中的偏移部分226而保持在远端的、固定的位置。随着远端推动器滑块边缘缩回并与近端刀杆偏移点232接触,刀支撑杆214与推动器滑块和杆一起开始朝近端缩回。随着刀支撑杆214缩回至导向块200中,支撑杆通过片簧250上升并与导向块接触,直到刀闭锁切口部分224勾住导向块的中心柱256(图23)为止。一旦刀切口部分224与导向块的柱256接合时,刀支撑杆214被防止与推动器滑块180结合的进一步运动。优选地,随着推动器滑块180和推杆190到达完全近端位置,刀支撑杆214与锁定切口部分224接合。
如图28所示,在致动调节器182完全收回之后,闩锁构件30相对于夹钳构件22、24枢转,以将上夹钳和下夹钳分离,如上所述。随着夹钳构件分离,钉仓90可被移除并用新的仓更换。用空的仓可通过在仓翼114上向上拉动被移除,以将仓腿110从下夹钳开口76分离。随着钉仓的近端端部提升至下夹钳开口76之外,仓腿凹口112(图7)被拖动以脱离与闩锁销122的接合。在钉仓90的近端端部脱离之后,仓可以朝远端滑动至仓槽70之外并被丢弃。
通过将新的钉仓的形成凸缘的远端端部顶着下夹钳仓槽70的远端端部推动并在翼114上向下推动使腿110下降穿过夹钳开口76可将新的钉仓90装载到下夹钳24中。仓腿110被推动穿过下夹钳开口76,直到腿的凹口112被摁入闩锁销122中为止。随着钉仓90的近端端部被向下推动,仓上的保护销106克服片簧250的反作用力在闭锁凹口228处压下刀支撑杆214。安全销106的力推动刀支撑杆切口224向下并脱离与导向块中心柱256的接触。随着刀支撑杆214向下推动,支撑杆与导向块中心狭槽220再次对齐,使得支撑杆朝远端穿过狭槽并进入到新的仓中。因此,在新的钉仓的装载过程中,安全保护特征被重置。在新的仓被装载的情况下,可通过将上夹钳22布置在下夹钳24上方并且将上夹钳销54再次插入到下夹钳对齐狭槽56中来再装配缝合器。闩锁钩构件140枢转返回至狭槽56的开口上方,直到销54置于凹口142中为止。在销54锁定在钩构件凹口142中并且闩锁构件30绕下夹钳24枢转至一定位置的情况下,缝合器被关闭并准备好从新仓发射缝合钉。
以上描述的可再使用的上夹钳和下夹钳以及闩锁构件组件在非无菌包装中被提供给用户。在装配缝合器20之前,所述组件用含酶的中性清洗剂进行清洗,然后进行蒸汽高压消毒,以给所述组件消毒。这个处理过程在组件的每次后续的再使用之前也要进行。致动模块170由于其具有多个可动组件,因此被设计为针对单个患者使用,以消除清洁所述模块而带来的麻烦。致动模块以无菌的一次性包装被提供给用户,该一次性包装在无菌环境下被打开。钉仓90也作为无菌的一次性包装被递送,该一次性包装在无菌环境下被打开。
为了装配缝合器20,致动模块170被从其包装中移除并且其近端端部首先被插入到下夹钳构件24的槽的近端中。当近端止动凸耳178与下夹钳止动特征86接合时,致动模块170被摁到一定位置上。致动模块的远端端部随后向下旋转至下夹钳24的槽形的框架中。在致动模块170位于下夹钳槽中的情况下,保护器顶盖234被向下推动,以将顶盖唇缘240摁入下夹钳侧壁64a、64b上的凹陷74中。在保护器顶盖234上向下推动的过程将导向块中心部分212推动穿过下夹钳开口76,将导向块狭槽212与下夹钳狭槽82对齐,并将致动模块锁定在下夹钳构件24中的一定位置上。在致动模块170被装载到下夹钳构件24中的情况下,通过将闩锁销122插入到狭槽82和212中来将闩锁构件30附着到下夹钳,如上所述。闩锁构件30相对于下夹钳构件24旋转到部分锁定位置上,如图14所示。在该位置,闩锁构件30附着到下夹钳构件24上,但是上夹钳22能够从下夹钳分离。通过将保护器顶盖沿着远端方向移动,保护器顶盖234被从致动模块170上移除,如附图中显示的顶盖上的箭头所指示。
新的钉仓90接着按照上述方式被插入到下夹钳仓槽70中。在装载钉仓之后,上夹钳构件22被布置在下夹钳构件24上方,同时销54被插入到对齐狭槽56中。闩锁构件30相对于上夹钳构件22和下夹钳构件24枢转,以将缝合器布置在预关闭位置(如图15所示),其中钩构件凸轮表面144在开口之上延伸至对齐狭槽56,以防止销54从狭槽脱离。将被横切的组织布置在砧44和钉仓90之间,并被调整至期望位置。组织止动件52防止组织被布置为进入缝合器太多。在组织正确定位的情况下,通过将闩锁构件30旋转至与下夹钳24接触以将钩构件140布置在狭槽56上方并将销54锁定在钩构件凹口142内,缝合器关闭以准备发射。在这种状态下,组织被夹持在所述装置中。如果需要额外的组织调整,则缝合器可返回到预关闭状态,如图16所示,其中上夹钳构件和下夹钳构件的远端端部可相对于彼此稍微移动,以容许组织重定位。在组织正确地夹持在夹钳构件之间并且闩锁构件30枢转至关闭的工作位置的情况下,可通过向前推动致动调节器182使其穿过导向狭槽186直至调节器停止来发射缝合器。随着调节器前进,夹持的组织被缝合和切割。在致动调节器182接触其远端止动件时,调节器穿过导向狭槽186被朝近端拉回。在调节器路径的近端,止动弹簧252和推动器滑块凹口254的交互作用提供提示调节器被完全收回的触觉和听觉反馈,这表示致动组件从钉仓90被拉回至模块盘172中。
如果需要额外的缝合和切割步骤来完成手术,则闩锁构件30枢转返回到部分锁定状态,从而上夹钳22可被取下,并且用空的钉仓被丢弃并用新的钉仓进行更换。在新的钉仓被布置好之后,闩锁构件30可枢转经过预关闭和关闭状态返回,以使得组织可通过利用新的仓被再次定位、夹持和缝合。一旦所有需要的组织都被解剖之后,通过将闩锁构件旋转返回至打开状态(见图13)并使闩锁销122滑出到狭槽82和212之外来取下闩锁构件30。致动模块170和钉仓90随后能够从下夹钳构件24取下并丢弃。其余的组件(上夹钳、下夹钳和闩锁构件)可作为分离的组件被清洁并消毒以备再使用。
在本发明中,致动模块170是与钉仓90分离的组件,使得用空的钉仓在单个患者的手术过程中能够被更换,而不用更换致动模块。因此,针对同一患者,致动模块可相对于不同的钉仓多次使用。将单件形式的模块盘172用作用于致动模块组件的支撑结构使得致动模块能够容易地装配到下夹钳槽中和从下夹钳槽中拆卸。可再使用的缝合器组件具有简单的单件式设计,以便于部件的重复的再处理和再使用。闩锁构件的可拆卸设计有利于缝合器的可再使用的组件被容易地分解和再装配。此外,一旦缝合器被装配好,闩锁构件和下夹钳构件的保持和闭锁特征就防止在手术过程中意外分解的发生。
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最好地以多个实施例利用本发明,并且在适合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 (21)
1.一种用于将缝合钉布署到组织中的手术缝合器,所述缝合器包括:
a.主体,所述主体具有远端端部、近端端部和它们之间的纵轴,所述近端端部包括手柄和近端通道,所述远端端部包括具有钉仓槽的下夹钳构件和具有砧的相对的上夹钳构件,所述主体还包括位于所述远端端部和近端端部之间用于将所述上夹钳构件和下夹钳构件连接在一起的闩锁构件,所述主体具有将所述闩锁构件和所述上夹钳构件及下夹钳构件连接和断开的组装状态;以及
b.用于布署所述缝合钉的致动模块,所述致动模块包括至少一个可纵向运动的构件,所述可纵向运动的构件用于朝着所述砧顺序地发射缝合钉,所述致动模块还包括模块盘,所述模块盘具有用于将致动模块可滑动地安装在所述近端通道内的装置,在所述主体处于将所述闩锁构件和所述上夹钳构件及下夹钳构件连接和断开的组装状态时,所述致动模块能够容易地从所述主体上移除和更换。
2.根据权利要求1所述的手术缝合器,还包括包含有多个缝合钉的钉仓,所述钉仓被设置在所述钉仓槽中。
3.根据权利要求2所述的手术缝合器,其中所述上夹钳构件和所述下夹钳构件每个都作为单件形成,所述上夹钳构件具有一对固定销,所述下夹钳构件包括一对对齐狭槽,所述上夹钳销插入到所述下夹钳狭槽中,以将所述夹钳构件对齐。
4.根据权利要求3所述的手术缝合器,其中所述闩锁构件将所述上夹钳构件和所述下夹钳构件在沿着所述缝合器的所述纵轴的中间位置连接在一起,所述闩锁构件相对于所述上夹钳构件和所述下夹钳构件能够移动。
5.根据权利要求4所述的手术缝合器,其中所述闩锁构件相对于所述上夹钳构件和所述下夹钳构件能够移动,以将所述缝合器置于一系列不同的锁定状态。
6.根据权利要求5所述的手术缝合器,其中所述闩锁构件作为单件式组件形成,其在关闭的锁定状态下能连接至所述缝合器并且在打开的锁定状态下从所述缝合器脱离。
7.根据权利要求6所述的手术缝合器,其中所述闩锁构件还包括闩锁销,所述闩锁销能插入到所述缝合器的主体上的狭槽中以将所述闩锁构件连接到所述缝合器,以及能从所述缝合器主体上的所述狭槽中移除以使所述闩锁构件脱离所述缝合器。
8.根据权利要求7所述的手术缝合器,其中所述缝合器还包括位于所述缝合器主体上的保持装置,用于将所述闩锁构件相对于所述上夹钳构件和所述下夹钳构件保持在所述不同的锁定状态。
9.根据权利要求6所述的手术缝合器,其中所述闩锁构件是单件式组件,其中所述上夹钳构件、所述下夹钳构件和所述闩锁构件能够从所述缝合器上分解并被单独地再处理,以备在不同的患者手术中再使用。
10.根据权利要求8所述的手术缝合器,其中所述保持装置能将所述闩锁构件保持在预关闭锁定状态,在该状态下,所述上夹钳销被防止从所述下夹钳狭槽中脱离,而所述钉仓能相对于所述砧移动。
11.根据权利要求8所述的手术缝合器,其中所述保持装置能将所述闩锁构件保持在部分锁定状态,在该状态下,所述闩锁构件连接至所述下夹钳构件,而所述上夹钳销能从所述下夹钳狭槽中脱离以使得所述上夹钳构件和所述下夹钳构件能够分离。
12.根据权利要求8所述的手术缝合器,其中所述闩锁构件还包括相对于所述下夹钳构件的相对的侧壁能够移动的钩闩锁构件,所述钩闩锁构件将所述上夹钳销接合在关闭的锁定状态下,以在工作位置将所述上夹钳构件和所述下夹钳构件固定在一起。
13.根据权利要求7所述的手术缝合器,其中所述致动模块还包括有利于将所述模块安装到所述缝合器主体上和从所述缝合器主体上取下的结构。
14.根据权利要求13所述的手术缝合器,其中所述模块盘包括保持所述至少一个可纵向运动的构件的槽形盘,所述槽形盘能够插入所述下夹钳构件的槽形框架中和能从所述下夹钳构件的槽形框架中移除,以允许所述可纵向运动的构件在所述槽形盘和所述钉仓之间运动。
15.根据权利要求14所述的手术缝合器,其中所述致动模块还包括开口,所述开口沿着所述缝合器纵轴与所述缝合器主体开口对齐,当所述闩锁销连接至所述缝合器主体时,所述闩锁销能够插入所述致动模块开口中和能够从所述致动模块开口中移除,以将所述致动模块保持在所述缝合器主体中。
16.根据权利要求15所述的手术缝合器,还包括相对于所述致动模块将所述钉仓连接至所述缝合器主体和从所述缝合器主体上脱离的结构,其中在所述缝合器主体中,能与一个致动模块使用多个钉仓。
17.根据权利要求16所述的手术缝合器,其中所述可纵向运动的构件包括切割构件和一对缝合钉致动杆,所述致动模块还包括导向装置,所述导向装置用于将所述切割构件和所述缝合钉致动杆与钉仓对齐以用于在所述致动模块和所述钉仓之间的往复运动。
18.一种用于将缝合钉布署到组织中的手术缝合器,所述缝合器包括:
a.上夹钳构件,所述上夹钳构件具有包括手柄的近端端部和包括砧的远端端部;
b.下夹钳构件,所述下夹钳构件具有近端槽形框架和包括钉仓槽的远端端部;
c.用于布署缝合钉的致动模块,所述致动模块包括至少一个可纵向运动的构件,所述可纵向运动的构件用于顺序地朝所述砧发射缝合钉,所述致动模块还包括模块盘,所述模块盘具有用于将致动模块可滑动地安装在所述近端槽形框架内的装置,由此所述致动模块能够容易地从所述下夹钳槽中移除和更换;
d.含有多个缝合钉的钉仓,所述钉仓设置在所述钉仓槽中;以及
e.闩锁构件,所述闩锁构件用于将所述上夹钳构件和所述下夹钳构件在沿着所述缝合器的纵轴的中间位置连接在一起,所述闩锁构件相对于所述上夹钳构件和所述下夹钳构件能够移动,用于将所述上夹钳构件和所述下夹钳构件连接在一起,所述闩锁构件具有将所述闩锁构件和所述上夹钳构件及下夹钳构件连接和断开的组装状态以及闭合状态,在所述闩锁构件处于将所述闩锁构件和所述上夹钳构件及下夹钳构件连接和断开的组装状态时,所述致动模块能够容易地从所述下夹钳构件上移除和更换。
19.根据权利要求18所述的手术缝合器,其中所述上夹钳构件、所述下夹钳构件和所述闩锁构件是单件式组件,这些单件式组件能从所述缝合器上分解并被单独地再处理并且随后再装配,以备在不同的组织缝合手术中再使用。
20.根据权利要求18所述的手术缝合器,还包括位于所述闩锁构件上的保持装置,用于将所述闩锁构件在一个或多个所述不同的锁定状态下保持在所述下夹钳构件上。
21.根据权利要求18所述的手术缝合器,其中所述闩锁构件处于初始打开状态以用于装配到所述上夹钳构件和所述下夹钳构件,并且在操作所述缝合器之前相对于所述夹钳构件运动至关闭的锁定状态,以防止在使用过程中所述闩锁构件从所述上夹钳构件和所述下夹钳构件脱离。
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US12/137,576 US8007513B2 (en) | 2008-06-12 | 2008-06-12 | Partially reusable surgical stapler |
PCT/US2009/047009 WO2009152307A1 (en) | 2008-06-12 | 2009-06-11 | A partially reusable surgical stapler |
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2008
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2009
- 2009-06-11 CA CA2726527A patent/CA2726527A1/en not_active Abandoned
- 2009-06-11 WO PCT/US2009/047009 patent/WO2009152307A1/en active Application Filing
- 2009-06-11 AU AU2009257442A patent/AU2009257442B2/en not_active Ceased
- 2009-06-11 WO PCT/US2009/047043 patent/WO2009152333A1/en active Application Filing
- 2009-06-11 CN CN200980121940.3A patent/CN102088916B/zh active Active
- 2009-06-11 EP EP09763597.3A patent/EP2299914B1/en active Active
- 2009-06-11 CA CA2726523A patent/CA2726523C/en not_active Expired - Fee Related
- 2009-06-11 CN CN200980121944.1A patent/CN102056553B/zh active Active
- 2009-06-11 AU AU2009257417A patent/AU2009257417B2/en not_active Ceased
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WO2009152307A1 (en) | 2009-12-17 |
AU2009257417B2 (en) | 2014-05-08 |
CN102056553B (zh) | 2014-05-28 |
AU2009257417A1 (en) | 2009-12-17 |
CN102088916A (zh) | 2011-06-08 |
US20090308907A1 (en) | 2009-12-17 |
WO2009152333A1 (en) | 2009-12-17 |
EP2299914A1 (en) | 2011-03-30 |
CN102056553A (zh) | 2011-05-11 |
AU2009257442A1 (en) | 2009-12-17 |
CA2726523A1 (en) | 2009-12-17 |
AU2009257442B2 (en) | 2013-10-10 |
CA2726523C (en) | 2016-10-11 |
EP2299914B1 (en) | 2014-03-19 |
CA2726527A1 (en) | 2009-12-17 |
US8007513B2 (en) | 2011-08-30 |
US20090308909A1 (en) | 2009-12-17 |
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