CN101156796A - 用于单腔进入吻合的紧固件的施放器 - Google Patents

用于单腔进入吻合的紧固件的施放器 Download PDF

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CN101156796A
CN101156796A CNA2007101627227A CN200710162722A CN101156796A CN 101156796 A CN101156796 A CN 101156796A CN A2007101627227 A CNA2007101627227 A CN A2007101627227A CN 200710162722 A CN200710162722 A CN 200710162722A CN 101156796 A CN101156796 A CN 101156796A
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CN101156796B (zh
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B·J·托普森
M·S·奥尔蒂斯
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Ethicon Endo Surgery Inc
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B17/1114Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis of the digestive tract, e.g. bowels or oesophagus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B2017/1139Side-to-side connections, e.g. shunt or X-connections

Abstract

一种用于单腔进入吻合的紧固件的施放器,环装置具有由近侧和远侧铰接臂连接的近侧、中央和远侧环,环装置未被致动时铰接臂具有基本上为长方形的径向回缩的形状,环装置被致动时铰接臂具有折叠的径向突出的形状,施放器包括:细长的执行部分和连接到其上的手柄;远侧致动构件,包括在锁定位置径向向外突出以接合所述远侧环的锁扣装置;近侧致动构件,其能够接合近侧环;致动机构,其布置在手柄处并能够使近侧和远侧致动构件沿着执行部分的纵向轴线朝向彼此运动,以接近近侧和远侧环,使铰接臂致动。远侧致动构件可绕着纵向轴线从锁定位置旋转到释放位置,由此沿着执行部分处的偏离表面滑动,能够径向向内推动锁扣装置使其与远侧环脱离。

Description

用于单腔进入吻合的紧固件的施放器
技术领域
本发明整体上涉及用于外科修复器官和脉管的装置和方法。更具体而言,本发明涉及用于将两个器官连接在一起的吻合装置,例如用于将两段小肠彼此连接、将一段小肠连接到胃上、或者在胆总管十二指肠吻合术中将胆总管连接到十二指肠上。
背景技术
世界上患病态肥胖症的人口比例正稳步增长。严重肥胖的人患心脏病、中风、糖尿病、肺病和其它意外疾病的风险增加。由于病态肥胖症对患者生活的影响,一直在研究治疗病态肥胖症的方法。
已经尝试各种非手术病态肥胖症治疗方法,但没有获得长效的成功。饮食咨询、行为矫正、用线将患者鄂关闭、药理方法都已经进行了尝试,尽管暂时有效,但不能根本矫正肥胖。另外,将例如食管-胃囊的物体导入胃中以填充胃的方法已经被用来治疗肥胖症。但是,这些方法易于引起胃功能紊乱,而且不能长期有效。
通过外科手术治疗肥胖症获得越来越大的成功。这些方法可以归结为:减小胃的有效尺寸,从而限制进食量的方法;以及引起所进食物的吸收不良的方法。例如,一些患者从可调节的胃束带(AGB)受益,所述胃束带在腹腔镜下围绕胃部放置,以形成所需尺寸的造口,允许食物填充胃的上部,从而引起饱涨感。为了能够在植入后调节造口的尺寸,流体导管在AGB的内置流体囊和经皮放置在患者胸骨前面的流体注射端口之间连通。然后,注射器针头可以根据需要注射或抽回流体以调节AGB。
尽管某种治疗肥胖症的方法对一些患者有效,但是其它患者发现他们的生活方式被不希望地改变,而进食量的限制使这种改变成为必须。另外,患者的身体状况暗示需要更长久有效的解决方案。为此,外科方法已经用来改变胃和/或小肠的用于消化食物的部分。产生吻合或者说在两根正常情况下不同的脉管之间通过外科方法形成通道是许多外科手术的关键步骤。在将小肠的两个部分连接在一起或者将小肠的另一部分连接到患者的胃上的胃旁路术尤其如此。在胰腺癌手术中通过从胆管将胆汁排向小肠以减轻胆总管的堵塞的手术中也是如此。
特别对于胃旁路手术,用于胃旁路术的进行腹腔镜吻合的现有方法包括钉合、缝合、以及放置可生物变碎环的方法,每种方法都具有大的挑战。例如,缝合很费时,并且取决于技术和熟练程度。钉合需要放置钉砧,钉砧是不能通过套管针端口导入的较大装置。必须通过剖腹来导入端口,这由于将内腔拉到剖腹手术进入部位而增加了伤口感染的机会。
作为钉合方法的一个例子,美国专利No.6543456公开的用于胃旁路术的方法包括将近侧和远侧吻合构件(例如钉砧)用抓钳经口插入。通过外科切割和钉合器械在内窥镜下横切胃和小肠,以形成胃囊、排出环以及鲁氏翼(Roux limb)。在内窥镜下插入的圆形钉合器连接到远侧吻合构件上以将排出环连接到小肠的远侧部分上,圆形钉合器连接到近侧吻合构件上以将鲁氏翼连接到胃囊上。之后,移除吻合构件以在胃和小肠的连接部分之间形成开孔。这种方法减小了腹腔镜端口的数量,避免了在腹腔镜下将吻合器械(例如圆形钉合器)插入扩大的手术端口,并消除了对肠切开和肠闭合的需要。
对于许多吻合术,医生使用圆形钉合器,直线型钉合器,或者手工缝合。但是,为了减小切口尺寸,并使手术过程技术要求更低更不费时,已经提出了单件式吻合装置,其在通过吻合施放器展开期间可变形以将组织部分保持在一起。美国专利公开2005/0070926A1和2005/0070935(通过引用将其包含在这里)描述了具有执行部分的吻合施放器,该执行部分接收具有圆柱的未致动形状的吻合环装置,该吻合环装置一端具有近侧环,另一端具有远侧环。该环装置还具有连接到近侧环上的近侧臂和连接到远侧环上的远侧臂。远侧臂的指向内侧的端部在中央环处连接到近侧环的指向内侧的端部上,使得当环在施放器致动期间被拉向一起时臂向外致动。闩锁机构将环锁定在铆钉状致动形状下。施放器包括径向突出的锁扣,其与环接合,使得可通过锁扣的平移运动来减小远侧环与中央环之间的间距和近侧环与中央环之间的间距。为了从致动的闩锁的环装置移除施放器,在每个锁扣的近侧设置释放斜面,当释放斜面与下一个完全致动的更近侧的环接触时使锁扣向内运动。美国专利申请US2005/0070926A1和US2005/0070935公开的吻合施放器和环装置使得可通过存在的套管针端口进行单腔进入吻合术,并在腔之间形成吻合连接,使得减轻对外科缝合和钉合的需要。
尽管如此,这些已知的装置的缺点在于,释放机构首先响应于锁扣的轴向运动而被击发,这使得环装置变形,然后响应于释放斜面与环装置的直接接触而被击发。因此,施放器可仅通过一次预定环变形来展开环装置,否则施放器从展开的环装置的回缩是不可能的。这意味着必须提供不同的施放器用于不同的组织厚度或不同的组织压缩程度,并且在环装置展开期间对组织压缩进行调节(远侧环和近侧环之间的距离的调节)是不可能的。
发明内容
因此,本发明目的在于改进已知的吻合施放器,使得可进行环压缩或者环逼近(即组织厚度)的调节并且可使用可调节的环装置。
通过根据后附权利要求1所述的吻合施放器来实现这些和其它目的。有利的实施方式是从属权利要求的目的。
根据本发明,提出一种用于吻合术环装置的施放器,所述环装置具有分别由近侧铰接臂和远侧铰接臂连接的近侧环、中央环和远侧环,当所述环装置未被致动时所述铰接臂具有基本上为长方形的径向回缩的形状,当所述环装置被致动时所述铰接臂具有折叠的径向突出的形状。所述施放器包括:细长的执行部分;连接到所述执行部分上的手柄;远侧致动构件,其包括锁扣装置,所述锁扣装置在锁定位置径向向外突出,以接合所述远侧环;近侧致动构件,其能够接合所述近侧环;致动机构,其布置在所述手柄处并能够使所述近侧和远侧致动构件沿着所述执行部分的纵向轴线朝向彼此运动,以接近所述近侧和远侧环,由此使所述铰接臂致动,其中,所述远侧致动构件可绕着所述纵向轴线从所述锁定位置旋转到释放位置,由此沿着所述执行部分处的偏离表面滑动,从而能够径向向内推动所述锁扣装置使其与所述远侧环脱离。由于绕执行部分的纵向轴线的旋转释放运动,释放独立于致动构件的轴向平移,并因此独立于环装置的变形的状态。这使得可利用吻合施放器来可调节地展开可闩锁的环装置,实现不同的环距离和不同的组织厚度。此外,通过在施放器的执行部分处设置偏离表面而不是将其形成在环装置上,可以优化环装置的设计用于两个组织部分的吻合连接,而无须考虑施放器结构。同样,施放器具有更多功能并且更不依赖于环装置。因此,不同的环装置(当然所有的都具有前面描述的基本特征)可通过吻合施放器展开。
根据本发明的有利的实施方式,致动机构适于使近侧致动构件向远侧运动并使远侧致动构件向近侧运动,从而使所述环装置的铰接臂致动,同时使所述中央环在所述执行部分上基本上保持固定。通过同时使两个致动构件朝向彼此运动,可将吻合环装置从其原始的圆柱形状展开并偏转成致动的铆钉形状,避免了施放器相对于组织的运动。对于现有技术,这种施放器的运动是必须的,以补偿环装置的中心沿着执行轴的运动。
根据本发明的另一方面,致动机构能够独立于远侧致动构件的轴向平移使近侧致动构件轴向平移,反之亦然。这使得施放器可选择地分别致动远侧和近侧铰接臂中的仅一组,以在组织夹紧之前辅助或改进组织定位和接近。此外,近侧和远侧致动构件的独立的平移运动使得可使环装置(即其中央环)例如在铰接臂展开和致动期间或者之前以受控的方式沿着执行部分平移。
根据本发明的一种替代实施方式,致动机构适于使远侧致动构件轴向平移,而近侧致动构件包括面向远侧的固定捕获表面,所述捕获表面形成在所述执行部分处,使得整体上形成特别简单且坚固的致动机构和施放器。本领域技术人员应当理解,通过朝着捕获表面向近侧拉动远侧致动构件,环装置会同时向近侧平移并且变形成其致动的铆钉形状。
回到施放器的释放机构,根据本发明的一个方面,执行部分包括具有轴向延伸的远侧窗槽的基本上圆柱形的外壳,远侧致动构件包括可滑动地接收于所述外壳内的轴和多个翼片形状的锁扣,多个翼片形状的锁扣从所述轴向外突出并通过所述远侧窗槽延伸,使得在处于所述锁定位置时,所述多个锁扣接合吻合环装置的远侧环。在该锁定位置,翼片能够径向或者切向延伸,或者在径向和切向之间成一角度倾斜地延伸。优选地,翼片沿着与致动构件从锁定位置转向释放位置的方向相反的方向偏斜或者倾斜,由此便于通过相应的窗槽的侧纵向边缘使翼片向内偏离,所述边缘用作上述偏离表面。
根据一种优选实施方式,圆柱形外壳还限定了多个轴线延伸的近侧窗槽,近侧致动构件包括可滑动地接收于所述外壳内的轴和多个翼片形状的锁扣,多个翼片形状的锁扣从所述轴向外突出并通过所述近侧窗槽延伸,使得在锁定位置时,所述多个锁扣接合吻合环装置的近侧环。近侧锁扣的布置、形状和释放机构优选与前面描述的远侧锁扣相同。远侧和近侧窗槽也可纵向连接并连续,从而相同窗槽的近侧和远侧部分分别用作近侧和远侧窗槽。
有利地,近侧和远侧致动构件被布置成可相对于彼此轴向滑动,而在绕纵向轴线旋转方面相联接,从而可通过两个致动构件相对于执行部分外壳的一个共同的旋转运动使远侧和近侧锁扣同时到达释放位置。
本发明具体涉及:
(1)、一种用于吻合环装置的施放器,所述环装置具有分别由近侧铰接臂和远侧铰接臂连接的近侧环、中央环和远侧环,当所述环装置未被致动时所述铰接臂具有基本上为长方形的径向回缩的形状,当所述环装置被致动时所述铰接臂具有折叠的径向突出的形状,所述施放器包括:
细长的执行部分和连接到所述执行部分上的手柄;
远侧致动构件,其包括锁扣装置,所述锁扣装置在锁定位置径向向外突出,以接合所述远侧环;
近侧致动构件,其能够接合所述近侧环;
致动机构,其布置在所述手柄处并能够使所述近侧和远侧致动构件沿着所述执行部分的纵向轴线朝向彼此运动,以接近所述近侧和远侧环,由此使所述铰接臂致动,
其特征在于,所述远侧致动构件可绕着所述纵向轴线从所述锁定位置旋转到释放位置,由此沿着所述执行部分处的偏离表面滑动,从而能够径向向内推动所述锁扣装置使其与所述远侧环脱离。
(2)、根据第(1)项所述的施放器,其中,所述致动机构能够使所述近侧致动构件向远侧运动并使所述远侧致动构件向近侧运动,从而使所述环装置的铰接臂致动,同时使所述中央环在所述执行部分上基本上保持固定。
(3)、根据第(1)项所述的施放器,其中,所述致动机构能够独立于所述远侧致动构件的轴向平移使所述近侧致动构件轴向平移,并且所述致动机构能够独立于所述近侧致动构件的轴向平移使所述远侧致动构件轴向平移。
(4)、根据第(1)项所述的施放器,其中,所述近侧致动构件包括面向远侧的固定捕获表面,所述捕获表面形成在所述执行部分处并能够接合所述近侧环,所述致动机构能够使所述远侧致动构件朝着所述捕获表面向近侧平移。
(5)、根据前述任一项所述的施放器,其中,所述执行部分包括具有轴向延伸的远侧窗槽的基本上圆柱形的外壳,所述远侧致动构件包括可滑动地接收于所述外壳内的轴,多个远侧锁扣从所述轴向外突出并通过所述远侧窗槽延伸,使得所述多个远侧锁扣接合吻合环装置的远侧环,在处于所述锁定位置时,所述远侧锁扣能够响应于所述远侧致动构件从所述锁定位置到所述释放位置的旋转而通过所述远侧窗槽的侧边缘径向向内偏离。
(6)、根据前述任一项所述的施放器,其中,所述圆柱形外壳还包括多个轴向延伸的近侧窗槽,所述近侧致动构件包括可滑动地接收于所述外壳内的轴,多个近侧锁扣从所述轴向外突出并通过所述近侧窗槽延伸,使得所述多个近侧锁扣接合吻合环装置的近侧环,在处于所述锁定位置时,所述近侧锁扣能够响应于所述近侧致动构件从所述锁定位置到所述释放位置的旋转而通过所述近侧窗槽的侧边缘径向向内偏离。
(7)、根据第(5)或(6)项所述的施放器,其中,所述锁扣基本上为翼片形状,在所述锁定位置,所述翼片沿着与所述致动构件从所述锁定位置旋转到所述释放位置的方向相反的方向倾斜,以便于使所述翼片通过所述窗槽的侧边缘)向内偏离。
(8)、根据第(5)或(6)项所述的施放器,其中,所述近侧和远侧致动构件被布置成可相对于彼此轴向滑动,而在绕纵向轴线旋转方面相联接,从而可通过两个致动构件相对于外壳的一个共同的旋转运动使远侧和近侧锁扣同时到达释放位置。
(9)、根据前述任一项所述的施放器,包括布置在近侧致动构件和远侧致动构件之间的中央致动构件,所述中央致动构件具有锁扣装置,所述锁扣装置能够接合所述环装置的中央环,以在所述远侧和/或近侧致动构件的致动运动期间控制其位置,所述中央致动构件能够绕纵向轴线从锁定位置旋转到释放位置,由此沿着执行部分处的偏离表面滑动,从而能够径向向内推动所述锁扣装置使其与所述远侧环脱离。
(10)、根据前述任一项所述的施放器,其中,所述中央致动构件本身也可通过中央环滑动控制器朝着近侧致动构件向近侧轴向运动和/或朝着远侧致动构件向远侧轴向运动。
(11)、根据第(9)或(10)项所述的施放器,其中,所述中央致动构件和远侧致动构件,或者所述中央致动构件、远侧致动构件和近侧致动构件被布置成可轴向滑动,而在转动方面相联接,从而可通过所有致动构件相对于外壳的一个共同的旋转运动使远侧、中央和近侧锁扣同时到达释放位置。
(12)、根据前述任一项所述的施放器,包括闩锁机构,所述闩锁机构能够携带可拆卸的按扣部件,所述按扣部件与环装置分离并且能够使所述近侧环与所述远侧环压扣连接,以将所述环装置锁定在其致动构型中。
(13)、根据前述任一项所述的施放器,其中,所述闩锁机构包括一个或多个可纵向平移的推动部分,所述推动部分相对于所述近侧锁扣或所述近侧捕获表面布置在近侧,并能够接合所述按扣部件的近侧端面并将按扣部件向近侧推动成与所述吻合环装置压扣接合。
(14)、根据前述任一项所述的施放器,其中,所述施放器装备有所述按扣部件,所述按扣部件包括环形近侧肩部和纵向部分,所述环形近侧肩部能够接合近侧环的近侧端面,所述纵向部分从环形近侧肩部向远侧突出并形成从纵向部分径向向外延伸的弹性支撑的按扣齿,以使远侧环能压扣接合,所述按扣部件的纵向部分限定了与所述近侧锁扣或捕获表面对齐并且与所述远侧锁扣对齐的槽,从而所述按扣部件可被推动成与所述环装置接合,而不会与所述致动构件发生干涉。
(15)、根据第(14)项所述的施放器,其中,所述按扣部件能够锁定所述环装置,使所述近侧环和所述远侧环之间具有不同的可调节距离。
(16)、根据前述任一项所述的施放器,其中,所述按扣部件包括多个按扣齿,所述多个按扣齿布置成沿着纵向部分的纵向延伸的列,从而所述环形近侧肩部与相同列的不同的按扣齿之间的距离对应于环装置的近侧和远侧环之间的不同的可调节距离。
(17)、根据第(15)或(16)项所述的施放器,其中,所述按扣部件的环形近侧肩部包括向远侧突出的具有外螺纹的调节部分,所述调节部分与设置在纵向部分的近侧基部处的内螺纹配合,从而可通过将调节部分或多或少地拧入纵向部分来调节肩部和按扣齿之间的距离。
(18)、根据第(17)项所述的施放器,其中,所述具有螺纹的调节部分也带有槽,以便在所述环装置的锁定期间不会与所述近侧锁扣或者捕获表面发生干涉。
(19)、根据第(13)或(17)项所述的施放器,其中,所述推动部分能够绕纵向轴线转动,并且能够接合按扣部件的环形肩部,从而所述旋转调节运动使得环形肩部可调节地拧入纵向部分。
附图说明
本发明的这些和其他特征和优点通过下面示例地示出了本发明的实施方式的附图将会变得更加清楚,这些附图和上面的总的描述以及下面对实施方式的具体描述一起用于解释本发明的原理,其中:
图1是用于内腔吻合的单腔进入的可展开的环的透视图,其安装于在腹腔镜下插入患者小肠的两个部分中每一个上的吻合目标部位的施放器上;
图2是单腔进入的可展开的环致动以接近小肠的两个部分之后的图1的施放器的视图;
图3是施放器的执行部分的详细的透视图,其携带了单腔进入的可展开的环,该环处于长方形的未致动的构型,施放器致动构件处于锁定位置;
图4是施放器的执行部分的详细的透视图,其携带了单腔进入的可展开的环,该环处于折叠的致动构型,施放器致动构件还是处于锁定位置;
图5是施放器的执行部分的详细的透视图,其携带了单腔进入的可展开的环,该环处于折叠的致动构型,施放器致动构件回缩在释放位置;
图6是施放器的执行部分和单腔进入的可展开的环的详细的透视图,该环处于折叠的致动构型,施放器通过环的中心移出;
图7和8是分别处于锁定位置和释放位置的施放器致动部分的放大的剖视图;
图9是根据本发明示例性实施方式的施放器的致动机构的详细的示意性透视图;
图9A是根据本发明示例性第二实施方式的施放器的致动机构的详细的示意性透视图;
图10-13示出了根据本发明第二实施方式的施放器的不同的操作构型;
图14-17示出了根据本发明第三实施方式的施放器的不同的操作构型;
图18-22示出了根据本发明的施放器的可拆卸的可调节按扣元件的不同方式。
具体实施方式
参照附图,其中所有附图中相同的附图标记表示相同的部件,图1示出了具有细长执行部分2的施放器1,该细长执行部分的尺寸适于通过套管针或者腹腔镜端口插入组织壁3、4以吻合两个内腔。施放器1的远侧引导尖端5通过吻合部位7处的开口6穿刺以定位致动部分8,该致动部分8保持用于单腔吻合的环装置9。环装置9具有三个主环,分别为近侧环10、中央环11和远侧环12,这些环彼此成一圆柱对齐。近侧环10通过近侧臂13纵向连接到中央环11上,中央环11又通过远侧臂14连接到远侧环12上。近侧臂13和远侧臂1 4分别通过铰接接头15和16分成两部分,铰接接头15和16限定了铰接到中央环11上的内壁段17、18和分别铰接到近侧环10和远侧环12上的外壁段19、20。在如图1所示的未致动状态,壁13、14基本上是长方形,并且环装置9至少大致是圆柱形。内壁段17、18和外壁段19、20的相对长度可以被选择以提供与组织壁3、4成需要的角度进行接触。在示例性形式中,这种关系类似于与内壁段17、18的悬臂接触,内壁段17、18致动成与组织壁3、4成大致平行关系。
手柄部分21在近侧连接到执行部分2的轴22上。轴22可以是刚性的或柔性的,是柔性时适于插入内腔,例如通过食道。手柄21包括用于纵向定位环装置9的环10、11、12的控制器。在示例性形式中,这包括远侧环滑动控制器23和近侧环滑动控制器24。尽管为了清楚示出了手动定位和致动的施放器1,但是应当理解,根据本发明的各个方面可以使用遥控定位和致动的施放器,以例如允许以更受控的方式放置,从而避免扰乱显像方式,或者其他别的原因。手柄21还可包括用于远侧尖端照明能力的控制器,使得远侧臂14在远侧内腔中的致动可以从内窥镜在近侧观察。应当理解,这里使用的术语“近侧”和“远侧”是相对于握持施放器1的手柄部分21的临床医生而言的。
在图2中,远侧环滑动控制器23已经向近侧回缩,近侧环滑动控制器24已经向远侧推进,使得远侧环12和近侧环10与中央环11锁定地接近,中央环11保持基本上不动。响应于此,近侧臂13和远侧臂14从环装置9的纵向轴线向外枢转,形成中空铆钉或沙漏形状,用于将组织壁3、4置于附近。中央环11座于内腔之间的组织接头处,远侧环12和近侧环10靠在相应的内腔中。通过在致动时将环10、11、12相互闩锁,环装置9保持在致动位置,弯曲的壁13、14接近组织。如图所示,近侧臂13可以与远侧臂14交错,以形成用于压缩的组织的弯曲路径。或者,壁13和14可以对齐以直接彼此配合。图3-8示例性示出了根据本发明第一实施方式的施放器1。
执行部分2包括基本上圆柱形的外壳25,其在致动部分8的区域中限定了多个轴向延伸的远侧窗槽26和多个轴向延伸的近侧窗槽27,远侧窗槽26和近侧窗槽27分别沿着远侧环12和近侧环10的致动运动的轨迹延伸。
远侧致动构件28包括轴29,其可滑动地收纳于外壳25中并可操作地通过拉杆31与远侧环滑动控制器23连接。多个翼片状的远侧锁扣30从轴29向外突出并通过远侧窗槽26延伸,使得它们在锁定位置时结合远侧环12的远端表面。在这种情况下,可通过使远侧环滑动控制器23在近侧方向移动而使远侧环12向近侧运动。
同样,近侧致动构件32包括轴33,其可滑动地收纳于外壳25中并可操作地通过推杆34与近侧环滑动控制器24连接。多个翼片状的近侧锁扣35从轴33向外突出并通过近侧窗槽27延伸,使得它们在锁定位置时结合近侧环10的近端表面。在这种情况下,可通过使近侧环滑动控制器24在远侧方向移动而使近侧环10向远侧运动。
如图9示意性示出的,近侧和远侧致动构件28、32能够相对于彼此(优选独立于彼此)平移,但它们在绕着执行部分2的纵向轴线X旋转方面例如通过几何连接件35相对于彼此有利地锁定。
手柄21包括释放控制器,例如旋钮37,其连接到拉杆31和/或推杆34上,并适于至少使远侧致动构件28(并优选使致动构件28和32)围绕执行部分2的纵向轴线X从锁定位置旋转到释放位置,在释放位置,锁扣30、35从吻合环装置9脱离,使得施放器的执行部分可通过环装置9的中央开口向近侧回缩。
如上面已经描述的,根据本发明,施放器1从环装置9的脱离通过如下特征实现:在致动构件28、32的旋转过程中,环装置的一部分在执行部分处(特别是在外壳25处)沿着偏离表面滑动,这能够径向向内推动锁扣30、35,至少使它们与远侧环12脱离。本领域技术人员应当理解,为了从环装置回缩施放器,近侧锁扣不必回缩。
根据附图所示的实施方式,锁扣30、35优选沿着与从锁定位置转向释放位置的方向相反的方向偏斜或者倾斜,由此便于通过相应的窗槽26、27的侧纵向边缘38使锁扣向内偏离,所述边缘38用作上述偏离表面。
在示例性形式中,外壳25和每个致动构件28、32由刚性聚合物或者金属片材形成。
在图3中,长方形的未致动的环装置9施加到施放器1的致动部分8上,远侧锁扣30和近侧锁扣35通过相应的窗槽26、27向外突出,并且与环装置9的远侧和近侧环12、10接合。
图4示例性示出了远侧环滑动控制器23已经向近侧移动并且近侧环滑动控制器24已经向远侧移动之后的情形,致动构件28、32使远侧环12和近侧环10朝着中央环11逼近,并且环装置9通过未示出的闩锁特征锁定在其致动的铆钉形状。在这种构型中,远侧和近侧锁扣30、35还处于其锁定位置,即,它们向外突出并防止施放器1从致动的环装置9回缩。
图5示例性示出了释放控制器37已经被旋转之后的情形,使得致动构件28、32围绕纵向轴线X从锁定位置旋转到释放位置,在释放位置,锁扣30、35通过窗边缘38向内弯曲并且与环装置9脱离。如图6所示,现在可将施放器1通过已致动且已展开的环装置9的中央开口向近侧移出。
图9-12示例性示出了根据本发明的第二实施方式的吻合施放器40,其中近侧致动构件和近侧环滑动控制器被去除,并且由固定的近侧捕获表面39替代,近侧捕获表面39适于与近侧环10的近侧端面接触,而远侧致动构件28基本上实施为参照图3-7描述的实施方式,除了远侧锁扣30的运动轨迹并因此远侧窗槽26的长度和远侧环滑动控制器23的滑动轨迹的长度对应于环装置的整个致动长度。
根据第三实施方式,如图14-17所示,施放器41包括闩锁机构,其适于携带与环装置9分离的可拆卸的按扣部件42,并适于使近侧环10和远侧环12压扣连接,以将环装置9锁定在其致动的铆钉形状。闩锁机构包括一个或多个可纵向平移的推动部分43,其相对于近侧锁扣35或近侧捕获表面39布置在近侧并且适于与按扣部件42的近端表面42接合并将按扣部件42向远侧推动成与吻合环装置9接合。推动部分43通过推杆(例如施加到执行部分2外部的管状推杆44)连接到专用的闩锁滑动控制器,例如推杆44的布置在手柄部分21附近的凸缘部分45。这允许在环装置9致动之后锁定环装置9,由此防止了可能妨碍对环逼近和施加到由环装置9夹紧的组织壁3、4上的压力的进行微调的自动锁定。
根据该实施方式,按扣部件42包括适于接合近侧环10的近端表面的环状近侧肩部46和从近侧肩部46向远侧突出并形成弹性支撑的按扣齿48的纵向部分47,所述按扣齿48从纵向部分47径向向外延伸,使远侧环12可压扣接合。按扣部件的纵向部分47和按扣齿48限定了与近侧锁扣35或捕获表面39对齐并优选与施放器1、40、41的远侧锁扣30对齐的槽49或者窗口,以能够将按扣部件42推动成与远侧环12对齐,而不会与施放器1的致动构件28、32发生干涉。
根据一种实施方式,按扣部件42适于锁定环装置9使近侧环10和远侧环之间12具有不同的可调节距离。该特征和施放器的上述适于独立于环装置的特定致动构型来释放环装置的环释放机构一起,使得可以以不同的组织厚度和压力等级来展开吻合环装置,并在环装置施放期间调节环构型和组织压力。
根据按扣部件42的示例性第一实施方式(图18、19),多个按扣齿48、48′(其中至少两个)布置成沿着纵向部分47的纵向延伸的列,使得环形近侧肩部46与相同列的不同的按扣齿48、48′之间的距离对应于环装置9的近侧环和远侧环10、12之间的不同的可调节距离。
根据示例性第二实施方式(图20、21),按扣部件42的纵向部分47限定了按扣齿48的仅一个周向排(至少两个沿直径相对布置的按扣齿),其适于与远侧环12压扣接合,而环形近侧肩部46包括向远侧突出的外部有螺纹的调节部分50,其与设置在纵向部分47的近侧基部51处的内螺纹配合,使得可通过或多或少地将调节部分50旋拧到纵向部分47中来调节肩部46和按扣齿48之间的距离。为了使按扣部件与施放器的致动机构相适应,有螺纹的调节部分50可开槽,以在闩锁期间不会与锁扣35或捕获表面39发生干涉。在该具体实施方式中,螺纹调节必须按分别与槽49或锁扣30、35的角度偏移相对应的角度逐步进行。
回到图14-17的实施方式,管状推杆44的凸缘部分45除了用作闩锁滑动控制器(平移闩锁运动)之外,优选用作用于使推动部分43围绕执行部分2的纵向轴线转动的旋转调节控制器。为此,推动部分43优选包括几何连接装置(例如齿、凹槽),其适于接合按扣部件42的环形肩部46,从而推动部分43的旋转调节运动使得环形肩部46拧入纵向部分47或者从其拧出。
根据示例性第三实施方式(图22),按扣部件42包括粗调装置和附加的微调装置。粗调装置由多个按扣齿48、48′实施,多个锁扣齿48、48′(其中至少两个)布置成沿着纵向部分47的纵向延伸的列,使得环形近侧肩部46与相同列的不同的按扣齿48、48′之间的距离与环装置9的近侧环和远侧环10、12之间的不同的可粗调距离相对应。微调装置由有外螺纹的调节部分50实施,其从环形近侧肩部46向远侧突出并与设置在纵向部分47的近侧基部51处的内螺纹配合。这样,可通过或多或少地将调节部分50旋拧到纵向部分47中来微调肩部46和所选的按扣齿48之间的距离。
根据又一种实施方式(图中未示出),按扣部件42本身限定了用于接收一组针或者缝钉的座,使得响应于推动部分43的远侧运动,按扣部件42运动成与环10、12压扣接合,并同时在吻合环装置9中推动该组针或者缝钉,由此穿刺保持在近侧环臂和远侧环臂之间的组织3、4。在这种情况下,该组针可有利地包括自支撑针环,其可布置在按扣部件42的环形肩部46上。
根据本发明的又一实施方式,其特征可与前述实施方式中描述和示出的特征相适应或着相结合,施放器1还包括中央致动构件52,其布置在近侧致动构件32和远侧致动构件28之间并具有锁扣装置53,该锁扣装置53适于接合环装置的中央环11,以在近侧和/或远侧致动构件的致动运动期间将其保持固定。
为了轴向锁定中央环11的位置,中央致动构件52的锁扣装置53包括合适的锁定表面,其径向向外突出并与中央环11的相应的凹槽或锁定表面接合,或者包围中央环或者其一部分,从而防止中央环沿近侧和远侧方向运动。
根据一种实施方式,中央致动构件52轴向固定但可绕着纵向轴线X从锁定位置转动到释放位置,由此在执行部分2处沿着偏离表面滑动,这能够径向向内推动锁扣装置53,以使其与中央环11脱离,如对于远侧或近侧致动构件的描述一样。
根据又一实施方式,中央致动构件52本身可通过中央环滑动控制器(图中未示出)朝着近侧致动构件向近侧轴向运动和/或朝着远侧致动构件向远侧轴向运动,该控制器优选构造成如远侧和近侧环滑动控制器23、24描述的一样。
具体而言,可独立于近侧和/或远侧致动构件的致动来优选保持中央致动构件52的固定位置或者进行中央致动构件52的纵向平移。
就致动构件从环装置的释放操作而言,根据一种实施方式,中央致动构件52和远侧致动构件28或者中央、远侧和近侧致动构件52、28和32布置成可轴向滑动但是转动相联的关系,使得可通过所有的致动构件相对于外壳25围绕纵向轴线X的一个共同的旋转运动使远侧、中央和近侧锁扣可同时到达其释放位置。
在使用中,环装置9接收在施放器1的执行部分2的致动部分8上。具体而言,环装置9的近侧环10靠在近侧锁扣35上,并且远侧环致动构件28的远侧锁扣30接合环装置9的远侧环12。临床医生操纵手柄21以将执行部分2插入穿过套管针的插管、腹腔镜端口或者穿过例如食道的内腔,以插入到吻合部位7。组织壁3、4放置在远侧(从医生的视角看),并且执行部分2的导入尖端5穿过形成在这些壁3、4中的开口6。导入尖端可具有穿刺形状和/或具有电磁或者热增强的切割特征,以辅助形成开口6。一旦环装置9的远侧臂14位于远侧内腔内,远侧环滑动控制器23可向近侧运动以将远侧臂致动成部分致动的环形。如此保持的远侧组织壁4可在必要时向近侧回缩,使得近侧臂13位于第一内腔内。
向远侧逐渐推动近侧环滑动控制器24使得近侧臂13部分致动。如果定位是正确的,则滑动控制器23、24可完全滑动,使得近侧和远侧臂13、14完全致动。如果环装置9设有自己的闩锁机构,其可在完全致动构型中自动闩锁,否则向远侧滑动和闩锁滑动控制器45,按扣部件42进入环装置9的内径内,并且与其近侧环和远侧环压扣接合。现在可通过旋转使得锁扣径向回缩的释放控制器37,来使得将施放器1保持到环装置9上的锁扣30、35脱离。然后,施放器的远侧尖端5从环装置9回缩,保持环装置9展开,形成吻合连接。随着时间经过,组织壁3、4永久地愈合在一起并且环装置9可以排出消化道,尤其是当其可生物变碎时更是如此。
尽管已经通过几种实施方式的描述示例性描述了本发明,尽管示例性实施方式已经描述得相当详细,但是申请人并不意图将后附权利要求的范围限制或者以任何方式限定为这些细节。本领域技术人员清楚地了解其它优点和变型。
例如,本发明的各个方面可应用于内窥镜和腹腔镜外科手术,也可应用于开放手术。这些或者类似术语的使用不应理解为将本发明限制成仅仅一类外科手术。
又如,尽管已经描述了用于使胃肠道的部分形成旁路的肥胖症手术,应当理解,通过吻合施放器和具有这里描述的各个方面的环装置可以使其它手术受益,例如胆管和血管旁路术。

Claims (4)

1.一种用于吻合环装置(9)的施放器(1),所述环装置具有分别由近侧铰接臂(13)和远侧铰接臂(14)连接的近侧环(10)、中央环(11)和远侧环(12),当所述环装置(9)未被致动时所述铰接臂(13、14)具有基本上为长方形的径向回缩的形状,当所述环装置(9)被致动时所述铰接臂(13、14)具有折叠的径向突出的形状,所述施放器(1)包括:
细长的执行部分(2)和连接到所述执行部分(2)上的手柄(21);
远侧致动构件(28),其包括锁扣装置(30),所述锁扣装置(30)在锁定位置径向向外突出,以接合所述远侧环(12);
近侧致动构件(32),其能够接合所述近侧环(10);
致动机构(23、24),其布置在所述手柄(21)处并能够使所述远侧和近侧致动构件(28、32)沿着所述执行部分(2)的纵向轴线(X)朝向彼此运动,以接近所述近侧和远侧环(10、12),由此使所述铰接臂(13、14)致动,
其特征在于,所述远侧致动构件(28)可绕着所述纵向轴线(X)从所述锁定位置旋转到释放位置,由此沿着所述执行部分(2)处的偏离表面(38)滑动,从而能够径向向内推动所述锁扣装置(30)使其与所述远侧环(12)脱离。
2.根据权利要求1所述的施放器(1),其中,所述致动机构能够使所述近侧致动构件(32)向远侧运动并使所述远侧致动构件(28)向近侧运动,从而使所述环装置(9)的铰接臂(13、14)致动,同时使所述中央环(11)在所述执行部分(2)上基本上保持固定。
3.根据权利要求1所述的施放器(1),其中,所述致动机构能够独立于所述远侧致动构件(28)的轴向平移使所述近侧致动构件(32)轴向平移,并且所述致动机构能够独立于所述近侧致动构件(32)的轴向平移使所述远侧致动构件(28)轴向平移。
4.根据权利要求1所述的施放器(1),其中,所述近侧致动构件(32)包括面向远侧的固定捕获表面(39),所述捕获表面(39)形成在所述执行部分(2)处并能够接合所述近侧环(10),所述致动机构(23)能够使所述远侧致动构件(28)朝着所述捕获表面(39)向近侧平移。
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EP1908422B1 (en) 2009-07-08
US7871418B2 (en) 2011-01-18
US20080221596A1 (en) 2008-09-11
CN101156796B (zh) 2010-11-17
DE602006007712D1 (de) 2009-08-20
EP1908422A1 (en) 2008-04-09

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