CN109069157A - 用于与圆形吻合缝合器一起使用的临时固定工具 - Google Patents
用于与圆形吻合缝合器一起使用的临时固定工具 Download PDFInfo
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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
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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
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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
- A61B17/07292—Reinforcements for staple line, e.g. pledgets
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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
- A61B17/10—Surgical instruments, devices or methods, e.g. tourniquets for applying or removing wound clamps, e.g. containing only one clamp or staple; Wound clamp magazines
- A61B17/105—Wound clamp magazines
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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
- A61B2017/07257—Stapler heads characterised by its anvil
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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
- A61B2017/07278—Stapler heads characterised by its sled or its staple holder
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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
- A61B2017/1157—Staplers for performing anastomosis in a single operation applying the staples radially
Abstract
本发明涉及圆形吻合缝合器和套件,该圆形吻合缝合器和套件包括加强支撑材料和固定工具,该加强支撑材料和固定工具可滑动地安装在此类缝合器的砧座轴上,这在将砧座插入到管状组织中期间提供了加强支撑物到圆形缝合器的砧座表面的临时机械固定。当载有支撑物的砧座处于期望位置时,沿砧座轴拉回固定工具并将固定工具移除。然后将轴连接到缝合头部并执行缝合。本发明还涉及使用套件和套件中的装置的方法。
Description
技术领域
本发明涉及用于增强由外科钉修复或接合的组织的特性的外科器械和方法,并且更具体地涉及被设计成增强目标外科手术部位处的修复或接合组织的特性的外科器械和方法,特别是在密封相邻肠节段之间的吻合部时。
背景技术
这些年来,医疗领域已经利用各种技术来将身体组织接合或粘结在一起。历史上,缝合是用于重新接合切断的组织和闭合伤口的可接受的技术。传统方法是利用外科手术针和缝合线来实现缝合,并且最近利用各种聚合物钉或金属钉来实现缝合。缝合线的预期功能是在愈合过程期间使伤口或组织的边缘彼此保持或接近,以便减少不适、疼痛、瘢痕和愈合所需的时间。当接合或吻合各种身体结构(诸如例如,肠)时,最近使用钉来替代缝合。用于施加这些钉的外科缝合装置通常被设计成同时切割和密封患者组织的延长区段。
外科医生采用线形或环形外科缝合装置来按顺序或同时将一行或多行外科紧固件(例如,钉或两部分紧固件)施加到身体组织,以用于将身体组织的区段接合在一起和/或用于形成吻合部。线形外科缝合装置通常包括一对钳口或指状结构,待接合的身体组织放置在该对钳口或指状结构之间。当致动和/或“击发”外科缝合装置时,击发杆纵向移动并接触钳口中的一个中的钉驱动构件,并且外科钉被推动穿过身体组织并进入和抵靠相对钳口中的砧座,从而将钉压接为闭合的。可提供刀片来在成行/成排的钉之间进行切割。
环形外科缝合装置通常包括环形钉仓组件(该环形钉仓组件包括多个环形钉行,通常二或三个)、与环形钉仓组件可操作地相关联的砧座组件、以及设置在钉行内部的环形刀片。一般而言,端对端吻合缝合器通常将一系列或一组钉放置到患者的肠或其它管状器官的近侧节段中。所得的吻合部包括肠的反向节段,该反向节段包括许多“B”形钉以保持肠的近侧节段之间的固定连接。
吻合渗漏可导致发病以及频繁死亡。除了使用外科钉,可将密封剂(例如,合成或生物密封剂)施加到外科手术部位以防止渗漏。通常在单独的步骤中使用双腔注射器或喷嘴将生物密封剂施加到吻合部的外部表面。密封剂的递送可能因不能到达各个钉部位处或各个钉部位之间而受到影响,并且沿钉线和组织接缝进行。
标题为“Hub for positioning annular structure on a surgical device”的美国专利7,793,813公开了一种用于在相邻肠节段之间设置环形结构的组件,该组件包括:a)环形外科缝合装置,该环形外科缝合装置具有砧座组件和管状主体部分,砧座组件具有砧座构件和砧座轴,管状主体部分承载呈环形构型的多个外科钉,管状主体部分具有设置在外科钉的径向内侧的连接构件,砧座构件的砧座轴包括凸缘并且可附接到管状主体部分的连接构件;以及b)毂,该毂适于支承在砧座轴上以接合砧座轴的凸缘,毂包括中心套筒和从中心套筒径向延伸的环形结构,该中心套筒限定穿过其的腔,该腔用于选择性地将砧座轴接收在其中,环形结构包括外环形盘和腹板,该外环形盘限定尺寸大于中心套筒的外径的中心开口,该腹板将盘与中心套筒相互连接,其中中心套筒包括基本上沿纵向延伸的至少一个弹性指状物,并且其中当毂支承在砧座轴上时,至少一个弹性指状物接合砧座轴的凸缘,以将环形结构定位在与砧座组件和管状主体部分中的每一者的组织接触表面间隔开一定距离的位置处。
标题为“Hub for positioning annular structure on a surgical device”的美国专利9,161,757公开了一种在相邻组织节段之间设置环形结构的方法,该方法包括以下步骤:a)提供包括砧座组件和主体部分的外科缝合装置,砧座组件包括支承在砧座轴上的砧座构件,并且主体部分承载多个外科钉和刀;b)提供用于在相邻组织节段之间定位环形结构的毂,毂包括中心套筒和环形结构,该中心套筒具有第一端部和第二端部,该第一端部和第二端部在它们之间限定腔,中心套筒被构造成选择性地接收和接合砧座组件的砧座轴,该环形结构从中心套筒的第一端部延伸并从其径向向外延伸;c)将砧座组件插入到第一组织节段中,使得砧座构件邻近第一组织节段的第一侧定位;d)在将砧座组件插入到第一组织节段中之后,通过将砧座轴穿过毂的第一端部并朝向毂的第二端部插入来将毂定位在砧座轴上,使得环形结构相对于砧座轴的纵向轴线同心地定位,并且使得环形结构紧邻第一组织节段的与第一组织节段的第一侧相对的第二侧定位;e)将主体部分插入到第二组织节段中;f)使砧座组件、毂和主体部分彼此接近,使得第一组织节段的端部部分、第二组织节段的端部部分和环形结构设置在砧座构件和主体部分之间;以及g)将砧座组件连接到外科缝合装置,使得砧座轴的近侧端部连接到安装在外科缝合装置的主体部分内的连接构件,其中环形结构设置在第一组织节段和第二组织节段之间。
标题为“Circular stapler buttress combination”的美国专利7,128,748公开了一种组合医疗装置,该组合医疗装置包括:a)圆形缝合器器械,该圆形缝合器器械包括具有中心凹孔的钉仓部件和具有中心凹孔的对应砧座部件,以及b)支撑材料的一个或多个部分,该支撑材料适于a)在使用之前或在使用时稳定地定位在缝合器器械的钉仓和/或砧座部件上,b)在定位在一个或多个缝合器器械部件上时,随后与缝合器器械部件一起被递送到组织部位,c)在将部件和一个或多个定位的材料部分递送到组织部位时,提供支撑材料的第一区域作为在启动缝合器器械时接合的组织节段之间的钉线支撑密封件,以及任选地d)允许在启动由缝合器器械提供的缝合器器械刀时移除支撑材料的第二区域的一个或多个部分,其中适于配合仓部件的支撑材料部分包括周向盘,该周向盘具有适于配合仓的中心凹孔的整体凸起的中心部分,并且适于配合砧座部件的支撑材料部分包括周向盘,该周向盘具有适于配合砧座的中心凹孔的整体凸起的中心部分。
标题为“Buttress Fixation for a Circular Stapler”的美国专利申请公布2014/0097224公开了一种圆形缝合装置,该圆形缝合装置包括:砧座组件,该砧座组件具有砧座构件和轴;管状主体部分,该管状主体部分具有钉仓,砧座组件的轴可连接到管状主体部分,使得砧座组件可朝向和远离管状主体部分移动,钉仓包括多个钉和推动器,该推动器具有用于驱动钉的指状物,指状物中的至少一个包括突起;支撑材料,该支撑材料通过至少一个锚定件可移除地附接到砧座组件、钉仓或两者;并且砧座组件和钉仓中的至少一者具有用于保持锚定件的凹口,推动器可移动以将突起移动成与凹口中的锚定件接合。
标题为“Buttress retainer for EEA anvil”的美国专利申请公布2014/0197224公开了一种用于将两个中空器官节段与环形阵列的外科钉接合的装置,该装置包括:钉仓组件,该钉仓组件包括成环形阵列的多个外科钉;砧座组件,该砧座组件包括砧座构件和从其延伸的轴,砧座构件包括限定用于使外科钉变形的多个钉凹坑的近侧表面,砧座组件可相对于钉仓组件在隔开位置和接近位置之间移动,以可调节地将组织夹持在钉仓和砧座组件之间;和支撑组件,该支撑组件包括:被构造成接合刀构件的环构件,环构件与砧座构件固定在一起;支撑构件,该支撑构件以叠加关系设置有多个钉凹坑,该多个钉凹坑限定在砧座构件中;以及保持构件,该保持构件具有附接构件,该附接构件被构造成与环构件固定在一起以将支撑构件固定在切割环和保持构件之间,并且使支撑构件相对于砧座组件定位。
标题为“Buttress support design for EEA anvil”的美国专利9,010,612公开了一种用于将两个中空器官节段与环形阵列的外科钉接合的装置,该装置包括:钉仓部件,该钉仓部件包括成环形阵列的多个外科钉;砧座部件,该砧座部件包括砧座构件和从其延伸的轴,砧座构件限定用于使多个外科钉变形的多个钉凹坑,砧座部件可相对于钉仓部件在隔开位置和接近位置之间移动,以可调节地将组织夹持在钉仓和砧座部件之间;支撑构件,该支撑构件与限定在砧座构件中的多个钉凹坑同心地对准;以及支撑底座,该支撑底座可拆卸地与砧座部件的轴固定在一起,支撑底座包括环形圈构件和至少一个支承构件,该至少一个支承构件从环形圈构件径向向外延伸,以将支撑构件固定到砧座构件,至少一个支承构件至少部分地位于支撑构件下方以向该支撑构件提供支承,其中支撑底座与支撑构件分离,并且支撑底座的环形圈构件固定到砧座部件的轴。
标题为“Circular Stapling Device Including Buttress Material”的美国专利申请公布2014/0217147公开了一种圆形缝合装置,该圆形缝合装置包括:柄部组件;细长主体,该细长主体从柄部组件延伸;端部执行器,该端部执行器安装在细长主体的远侧端部上并且包括仓组件和砧座组件,砧座组件包括:圆形砧座头,该圆形砧座头支承挤压环;砧座帽,该砧座帽连接到砧座头,砧座帽可相对于砧座头在接近位置和未接近位置之间移动,挤压环在砧座帽设置在接近位置时与砧座帽间隔开,并且可移动成与砧座帽接合以将砧座帽移动到未接近位置,砧座帽支承O形环;以及圆形砧座支撑构件,该圆形砧座支撑构件包括主体部分和从主体部分延伸的延伸部分,主体部分支承在砧座头的组织接合表面上,当砧座帽设置在接近位置时,延伸部分可固定在O形环和砧座头之间,当砧座帽设置在未接近位置时,延伸部分可从O形环和砧座头之间释放,使得主体部分与砧座头的组织接合表面分离。
标题为“Surgical device including buttress material”的欧洲专利申请公布2,620,107A1公开了一种用于接合组织部分的外科缝合装置,该外科缝合装置包括:柄部组件;管状主体部分,该管状主体部分支承在柄部组件的远侧端部上,管状主体部分具有包括成环形阵列的多个外科钉的钉仓组件;砧座组件,该砧座组件位于缝合装置的远侧端部处,砧座组件具有用于将砧座组件可移除地连接到管状主体部分的轴,砧座组件和管状主体部分沿轴相对于彼此并置并且被布置成相对于彼此接近;支承构件,该支承构件从管状主体部分朝向砧座组件延伸;以及支撑材料,该支撑材料由支承构件支承并且可移除地附接到支承构件,支撑材料设置在砧座组件和钉仓组件之间。
标题为“Surgical stapling apparatus including buttress attachmentviatabs”的美国专利8,967,448公开了一种用于将两个中空器官节段与环形阵列的外科钉接合的装置,该装置包括:钉仓部件,该钉仓部件包括成环形阵列布置的多个外科钉,钉仓部件包括在其中限定周向凹槽的外壁;砧座部件,该砧座部件可相对于钉仓部件在隔开位置和接近位置之间移动,以可调节地将器官节段夹持在钉仓和砧座部件之间;支撑部件,该支撑部件被构造成并且尺寸被设定成定位在钉仓部件的远侧表面上,支撑部件包括支撑构件和从支撑构件朝近侧延伸的多个周向布置的突片,每个突片具有一定长度,使得当支撑构件覆盖在钉仓部件的面向组织的表面上时,突片延伸穿过钉仓部件的周向凹槽;以及紧固构件,该紧固构件被构造成并且其尺寸被设定成使多个周向布置的突片接合到钉仓部件的周向凹槽中,以将支撑部件固定地定位在钉仓部件上。
标题为“Structure Containing Wound Treatment Material”的美国专利申请公布2013/0068819公开了一种用于圆形缝合装置的砧座组件,其中砧座组件包括砧座头,该砧座头被构造成在其上支承砧座板;轴,该轴从砧座头延伸并且被构造成选择性地接合圆形缝合装置的连接构件;砧座板,该砧座板可操作地连接到砧座头,砧座板在其中限定多个钉成形凹坑;以及伤口处理材料,该伤口处理材料设置在砧座板的每个钉成形凹坑中。伤口处理材料为粘合剂、密封剂、止血剂和药物中的至少一种。
标题为“Annular Adhesive Structure”的美国专利8,152,042公开了一种用于在吻合部位处进行密封的装置。在一些实施方案中,垫圈或结构主体被完全封装在砧座轴周围,其中钉被驱动穿过结构主体以释放密封剂。
吻合密封术的术后渗漏已被示为在一些情况下会导致发病和死亡。许多技术旨在通过使用应用于被接合的组织的支撑物或类似的加强结构来加强组织而解决渗漏。然而,由于难以进入部位并且还由于需要具有适用于外科医生可用的各种吻合缝合器的装置和方法,因此缺乏可靠且快速的技术来安装支撑物并就在缝合组织之前固定支撑物并且建立吻合接头。通过粘合剂或保持环固定支撑物的替代方法比较复杂,并且可能导致支撑物与砧座发生不可靠分离。将砧座插入到管状组织中仍然具有挑战性,因为在插入期间组织粘膜壁倾向于将支撑物与砧座表面分离。需要能够在吻合缝合之前正确定位支撑物并保持支撑物的装置。
发明内容
本发明涉及用于增强由外科钉修复或接合的组织的特性的外科器械和方法,并且更具体地涉及被设计成增强目标外科手术部位处的修复或接合组织的特性的外科器械和方法,特别是在密封相邻肠节段之间的吻合部以便改善组织活力并且防止渗漏时。
简而言之,根据本发明的一个实施方案,使用支撑物或加强O形环垫圈来增强吻合接头需要在进行缝合之前在将砧座插入到肠中期间抵靠砧座保持支撑物。可滑动地安装在砧座轴(或销)上的固定工具在将砧座插入到管状组织中期间提供了支撑物到圆形缝合器的砧座表面的临时机械固定。当载有支撑物的砧座处于期望位置时,沿砧座轴拉回固定工具并将固定工具移除,并且固定工具不再支承支撑物。然后将轴连接到缝合头部并执行缝合。
简而言之,根据另一个实施方案,固定工具在砧座轴上滑动,并且在插入到管状组织诸如肠组织或结肠中期间将支撑物推进/压进砧座中。固定工具处的凸块或突起与支撑物接合,以防止支撑物粘附到固定工具上,并防止在移除固定工具时将支撑物从砧座拉回。具有与砧座相邻的圆锥形状的固定工具改善了插入和抽出情况。
在另一个实施方案中,本发明涉及一种圆形缝合器,该圆形缝合器包括:圆形砧座,该圆形砧座具有平坦面向表面;缝合头部组件,该缝合头部组件具有相对的平坦表面;砧座轴,该砧座轴接合砧座和缝合头部组件;支撑材料,该支撑材料定位在面向表面上;以及固定工具,该固定工具在近侧端部处具有带有外圆周的细长圆柱形套筒,并且在远侧端部处具有截头圆锥形凸缘,其中内部轴向开口穿过套筒和凸缘的整个长度,所述凸缘在远侧端部处终止于平面部分,所述平面部分具有的直径大于圆柱形套筒的直径,并且多个凸块设置在所述平面部分上,所述套筒具有在近侧端部处开始并沿套筒朝向凸缘延伸的至少一个狭缝。
在另一个实施方案中,本发明涉及一种利用吻合缝合器在管状组织腔之间建立吻合接头的方法,该方法包括以下步骤:将支撑物和固定工具定位在用于圆形缝合器的砧座轴上;将固定工具在砧座轴上朝向砧座可滑动地推进;利用固定工具使支撑物抵靠砧座固定不动;将固定工具临时保持在砧座轴上的第一位置;将具有支撑物和固定工具的砧座插入到第一管状组织中;从第一管状组织移除固定工具,从而在第一管状组织内留下具有支撑物的砧座;使设置在第一管状组织内的具有支撑物的砧座接近设置在第二管状组织内的缝合头部;压缩缝合头部和具有支撑物的砧座之间的第一管状组织和第二管状组织,该支撑物设置在缝合头部和砧座之间但在第一管状组织内;击发吻合缝合器,从而在第一管状组织和第二管状组织之间建立由支撑物加强的缝合吻合接头。
附图说明
图1示出了用于执行圆形吻合缝合操作的外科吻合缝合器械或缝合装置的透视图。
图2示出了本发明的临时固定工具的透视图。
图3示出了本发明的临时固定工具的示意性正视图/透视图。
图4A示出了本发明的临时固定工具的透视图。
图4B和图4C示出了比较固定装置的透视图。
图5A示出了本发明的临时固定工具的示意性剖面侧视图。
图5B示出了比较固定装置的示意性剖面侧视图。
图6A示出了支撑物的透视图。
图6B、图6C、图6D示出了抵靠支撑物定位的临时固定工具的示意性剖面侧视图。
图7A至图7F以示意性剖面侧视图示出了执行管状组织腔的吻合接合的顺序。
具体实施方式
外科手术经常涉及将两层或更多层组织接合在一起,以及沿钉线对该组织的一部分可选地同时划分节段。例如,结直肠外科手术在许多情况下包括结肠和直肠区段的切除。结直肠切除之后,利用圆形缝合器将结肠和直肠牵拉到一起并且执行端对端吻合术。吻合术的术后渗漏已被示为导致发病和死亡。
典型的外科缝合器械具有包括钉的部件和相对的砧座部件,在从包括钉的部件递送钉之前至少两个待接合的组织层被压缩于该包括钉的部件和砧座部件之间,由此钉穿透两个组织层并且弯曲、变形、或者抵靠相对的砧座部件闭合。
现在参见图1,示出了用于执行圆形吻合缝合操作的通用外科吻合缝合器械或缝合装置,其中该图取自美国专利5,271,544“Surgical anastomosis staplinginstrument”,该专利转让给Ethicon,Inc.,Somerville,NJ并且其全文以引用方式并入本文用于所有目的。所示的缝合装置的各种修改和迭代在本领域中是已知的,其具有类似的特征。圆形吻合外科缝合器械500包括远侧缝合头部组件600,该远侧缝合头部组件由纵向弯曲的支承轴组件700连接到近侧致动器柄部组件800。缝合器械包括砧座组件或砧座1000,该砧座组件或砧座可相对于缝合头部组件600滑动并且安装在轴向延伸的可运动轴1040上。可选地可旋转的调节旋钮820设置在致动器柄部组件800的近侧端部处以用于调整缝合头部组件600和砧座组件1000之间的空间。通过柄部组件800顶部上的可选窗850,可选的可运动的指示器840为可视的,以指示通过旋转可调节的旋钮820选择的钉高度。指示器840为可运动的,其指示砧座间隙位于缝合器械500的期望操作范围内。指示器840的位置还指示所选钉高度是大还是小。
钉致动杆860可枢转地安装在致动器柄部组件800上以用于在砧座组件1000闭合以提供期望的钉高度时从缝合头部组件600驱动外科钉。枢转的闩锁构件880安装在柄部组件800上以用于在砧座间隙位于预定范围外部时锁定钉致动杆860防止其运动以消除缝合头部组件600的致动。缝合头部组件600包括管状壳体610以及壳体610的近侧端部处的中空管状连接器640,该连接器接收支承轴700的远侧端部。套圈或套筒720与管状连接器640和支承轴700的远侧端部之间的接头叠置。支承轴700的近侧端部由致动器柄部组件800的远侧端部处的管状伸出部740接收。套圈或套筒760与支承轴700的近侧端部和管状伸出部740的远侧端部之间的接头叠置。通过柄部组件800顶部上的窗850,可运动的指示器840为可视的,以指示通过旋转可调节的旋钮820选择的钉高度。
圆形外科缝合器的其它型式和修改对本领域的技术人员而言是已知的。通常存在至少两个并且很多情况下存在更多同心的缝合线或同心的圆形成行的包括钉的狭槽围绕轴1040,其中每行中的钉相对于邻行中的钉交错或偏置,以改善密封并且防止沿缝合线的渗漏。
吻合术可通过本领域已知的各种技术来执行。在一种例示性技术中,使用吻合缝合器来执行结肠与直肠的低吻合。简而言之,在穿过肛门插入缝合器500之后,将降结肠固定在砧座1000周围,其中荷包缝合线系在轴周围,并且直肠残端固定在缝合头部600周围,其中荷包缝合线也系在轴周围。然后将砧座1000拉向缝合头部600,并且随后将钉展开以在降结肠和直肠残端各自的浆膜表面处接合它们的组织,同时伴随缝合器500内的圆形刀或手术刀(未示出)切掉最靠近轴1040的多余组织(倒肠)这一动作,从而形成吻合部。然后移除缝合器500。
用于定位环形结构的临时固定工具10,诸如用于与圆形吻合缝合器一起使用的支撑物以透视图在图2和图4A中示出,以正视图/透视图在图3中示出,并且以示意性剖面侧视图在图5A中示出。固定工具10包括细长套筒20,该细长套筒在远侧端部22处具有圆锥形凸缘50。轴向开口100穿过套筒20和凸缘50,并且该轴向开口的尺寸被设定成可滑动地配合在圆形缝合器的轴上。
凸缘50在远侧端部22处终止于平面部分60,其中平面部分60具有的直径大于套筒20的直径并且靠近缝合器砧座1000(图1)的直径。平面60具有多个凸块或突起70,该多个凸块或突起具有至少2个凸块、更优选地8个凸块或多达200个或至多1000个凸块70,诸如20个、30个、40个、60个、80个凸块70。
近侧端部21处的套筒20具有可选的抓持部40,该抓持部包括多个凸起的周向脊40或多个周向沟槽(未示出)。在一些实施方案中,存在3个、4个或5个脊40。套筒20具有至少一个、优选地两个或更多个狭缝或切口30,该狭缝或切口在近侧端部21处开始并朝向凸缘50延伸穿过套筒20,但终止于凸缘50之前。示出了彼此相对的两个狭缝30,但是可以设想对称地设置在套筒20上的3个、4个、5个、6个或更多个狭缝30。狭缝30的尺寸被设定成一旦将固定工具10安装到砧座轴1040上就能够手动压缩套筒20,以用于使固定工具10在砧座1000上固定不动。
固定工具10优选地一体形成,或者其可通过将凸缘50与套筒20接合来组装。固定工具10可由任何合适的惰性材料诸如聚合物材料、复合材料、金属等制成,并且可通过注塑成型、机械加工、冲压等制造而成。
套筒20(不包括脊40或沟槽)的外径比砧座轴1040的直径大约10%至100%。在一些实施方案中,套筒20的外径为约5mm至约10mm,诸如8mm。
套筒20的长度为约15mm至约60mm,诸如20mm、30mm、40mm。
轴向开口100的直径的尺寸被设定成可滑动地配合在圆形缝合器的轴1040上,其中轴向开口100的直径相对于砧座轴1040的直径大1%至10%或20%。在一些实施方案中,轴向开口100的直径为约4mm至约10mm,诸如7mm。
平面60的直径的尺寸被设定成类似于砧座1000的最大直径,即为砧座1000的最大直径的约80%至约125%,诸如砧座1000的最大直径的90%、100%、110%。在一些实施方案中,平面60的直径为20mm、22mm、25mm、30mm。
突起70的凸块通常是球形或半球形或者椭圆形,其中高度为约0.5mm至约4mm,诸如1mm、1.5mm、2mm、3mm。如半球形实施方案中所示,高度为大约半的球直径的一半。
在一些实施方案中,抓持部40是凸起的周向脊,该凸起的周向脊具有直径为1mm至2mm诸如直径为1.6mm的半球形横截面。
狭缝30的宽度为约0.1mm至约1mm,诸如宽度为0.5mm或0.8mm,并且长度为套筒20的长度的约50%至套筒20的长度的约100%,诸如80%或90%。在一些实施方案中,狭缝30的长度为18mm、25mm或30mm。
圆锥形凸缘50通过从较大直径的平面60过渡到较小直径的套筒20而形成,其中锥角25在约25度至约65度的范围内,诸如锥角25为30度、45度、60度。固定工具10的总长度为约25mm至50mm,诸如30mm。
现在参见图4A、图4B、图4C,相对于替代实施方案,诸如在平面60中具有沟槽75的装置11(图4B)或在平面60中没有特征部的装置12(图4C),对本发明的固定工具10进行了比较测试。本文的发明人发现,在GI圆形吻合术的动物测试中,比较装置未能固定支撑物或与支撑物分离,而如图所示具有10列4个半球形凸块的本发明的固定工具10表现良好。
现在参见图5A、图5B,相对于替代实施方案,诸如装置13(图5B),对本发明的固定工具10进行了比较测试,该装置13具有整体结构和相同的凸块70,但是具有不是圆锥形凸缘的凸缘55作为本发明的固定工具10的凸缘50。本文的发明人发现,在GI圆形吻合术的动物测试中,比较装置13未能充分地固定支撑物或与支撑物分离,而具有圆锥形凸缘50的本发明的固定工具10表现良好。
现在参见图6A至图6D,固定工具10被示出为具有环形结构,诸如支撑物250,由此:图6A以透视图示出了通常为O形环的环形结构或支撑物250;图6B示出了固定工具10抵靠支撑物250的示意性剖视图,其中平面60的直径基本上等于支撑物250的直径;图6C示出了固定工具10抵靠支撑物250的示意性剖视图,其中平面60的直径小于支撑物250的直径,诸如小10%至25%;图6D示出了固定工具10抵靠支撑物250的示意性剖视图,其中平面60的直径大于支撑物250的直径,诸如大10%至25%。
现在参见图7A至图7F,以示意性剖视图示出了在吻合缝合组织期间使用固定工具10的步骤顺序。图7A示出了接近砧座1000安装在轴1040上的支撑物250,其中固定工具10可滑动地定位在轴1040上,并且凸缘50面向砧座1000。箭头A表示移动固定工具10的方向。
图7B示出了支撑物250,通过固定工具10抵靠砧座1000固定支撑物250并使支撑物250抵靠砧座1000固定不动,该固定工具抵靠砧座1000保持支撑物250。箭头B表示压缩或挤压套筒20以使固定工具10在轴1040上固定不动的方向。
图7C示出了砧座1000与支撑物250一起插入到管状组织T1(通常为肠或结肠组织)中,通过固定工具10抵靠砧座1000固定支撑物250并使支撑物250抵靠砧座1000固定不动。T1可具有荷包(未示出),其用于围绕轴1040部分地使闭合管状组织接近。
然后,沿轴1040小心地可滑动地从管状组织T1移除固定工具10,从而在管状组织T1内留下砧座1000和支撑物250,如图7D所示。
然后拉紧荷包(未示出),从而导致围绕轴1040闭合管状组织T1并覆盖砧座1000和支撑物250。然后将轴1040插入到设置在管状组织T2内的缝合头部600中。
如图7E所示,然后使设置在管状组织T1内的具有支撑物250的砧座1000与设置在管状组织T2内的缝合头部600彼此接近,同时压缩它们之间的组织T1和T2。
图7F示出了钉320被击发并且吻合缝合器被移除,从而建立由支撑物250加强的吻合接头。
在操作中,如上所示,健康专业人员执行以下步骤:
·将支撑物250和固定工具10定位在砧座轴1040上;
·将固定工具10在砧座轴1040上朝向砧座1000可滑动地推进;
·利用固定工具10使支撑物250抵靠砧座1000固定不动;
·手动挤压套筒20以将固定工具10保持或临时锁定在砧座轴1040上;
·将具有支撑物250和固定工具10的砧座1000插入到管状组织T1中;
·从管状组织T1移除固定工具10,从而在管状组织T1内留下具有支撑物250的砧座1000;
·使设置在管状组织T1内的具有支撑物250的砧座1000与设置在管状组织T2内的缝合头部600接近;
·压缩缝合头部600和具有支撑物250的砧座1000之间的组织T1和T2,该支撑物设置在缝合头部600和砧座1000之间但在组织T1内;
·击发吻合缝合器,从而在组织T1和T2之间建立由支撑物250加强的吻合接头。
有利地,如从图7F可以看出,在缝合之后,支撑物250设置在组织T1内。
虽然上文已参考本发明的具体实施方案描述了本发明,但明显的是,在不脱离本文所公开的发明构思的条件下,可作出多种变化、修改和变型。因此,本文旨在涵盖落入所附权利要求书的实质和广义范围内的所有此类变化、修改和变型。本文引用的所有专利申请、专利以及其它出版物均全文以引用方式并入。
Claims (11)
1.一种圆形缝合器,包括:
a)圆形砧座,所述圆形砧座具有平坦面向表面;
b)缝合头部组件,所述缝合头部组件具有相对的平坦表面;
c)砧座轴,所述砧座轴接合所述砧座和所述缝合头部组件;
d)支撑材料,所述支撑材料定位在面向表面上;以及
e)固定工具,所述固定工具在近侧端部处具有带有外圆周的细长圆柱形套筒并且在远侧端部处具有截头圆锥形凸缘,其中内部轴向开口穿过所述套筒和所述凸缘的整个长度,
所述凸缘在所述远侧端部处终止于平面部分,所述平面部分具有的直径大于所述圆柱形套筒的直径,并且多个凸块设置在所述平面部分上,
所述套筒具有在所述近侧端部处开始并沿所述套筒朝向所述凸缘延伸的至少一个狭缝。
2.根据权利要求1所述的缝合器,还包括设置在所述套筒的所述近侧端部处的多个周向抓持部,所述抓持部包括沿所述套筒的所述外圆周的凸起的脊或沟槽。
3.根据权利要求1所述的缝合器,其中所述固定工具包括至少两个狭缝、20至80个凸块以及三至八个平行的周向抓持部。
4.根据权利要求1所述的缝合器,其中所述固定工具的所述内部轴向开口配合在圆形缝合器的所述砧座轴上。
5.根据权利要求1所述的缝合器,其中所述支撑材料是可生物吸收的。
6.一种利用吻合缝合器在管状组织腔之间建立吻合接头的方法,包括以下步骤:
a)将支撑物和固定工具定位在用于权利要求1所述的圆形缝合器的砧座轴上;
b)将所述固定工具在所述砧座轴上朝向砧座可滑动地推进;
c)利用所述固定工具使所述支撑物抵靠砧座固定不动;
d)将所述固定工具临时保持在所述砧座轴上的第一位置;
e)将具有所述支撑物和所述固定工具的所述砧座插入到第一管状组织中;
f)从所述第一管状组织移除所述固定工具,从而在所述第一管状组织内留下具有所述支撑物的所述砧座;
g)使设置在所述第一管状组织内的具有所述支撑物的所述砧座接近设置在第二管状组织内的缝合头部;
h)压缩所述缝合头部和具有所述支撑物的所述砧座之间的所述第一管状组织和所述第二管状组织,所述支撑物设置在所述缝合头部和所述砧座之间但在所述第一管状组织内;
i)击发所述吻合缝合器,从而在所述第一管状组织和所述第二管状组织之间建立由所述支撑物加强的缝合吻合接头。
7.根据权利要求6所述的方法,其中所述缝合器还包括设置在所述套筒的所述近侧端部处的多个周向抓持部,所述抓持部包括沿所述套筒的所述外圆周的凸起的脊或沟槽。
8.根据权利要求6所述的方法,其中所述固定工具包括至少两个狭缝、20至80个凸块以及三至八个平行的周向抓持部。
9.根据权利要求6所述的方法,其中所述固定工具的所述内部轴向开口配合在圆形缝合器的所述砧座轴上。
10.根据权利要求6所述的方法,其中所述支撑材料是可生物吸收的。
11.根据权利要求6所述的方法,其中所述平面部分直径的尺寸被设定成为所述砧座的直径的约80%至约125%。
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US15/075,780 US10278703B2 (en) | 2016-03-21 | 2016-03-21 | Temporary fixation tools for use with circular anastomotic staplers |
US15/075780 | 2016-03-21 | ||
PCT/US2017/022417 WO2017165165A1 (en) | 2016-03-21 | 2017-03-15 | Temporary fixation tools for use with circular anastomotic staplers |
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US (1) | US10278703B2 (zh) |
EP (1) | EP3432808A1 (zh) |
JP (1) | JP2019511296A (zh) |
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Also Published As
Publication number | Publication date |
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MA44485A (fr) | 2019-01-30 |
EP3432808A1 (en) | 2019-01-30 |
JP2019511296A (ja) | 2019-04-25 |
US10278703B2 (en) | 2019-05-07 |
WO2017165165A1 (en) | 2017-09-28 |
BR112018069127A2 (pt) | 2019-01-22 |
US20170265867A1 (en) | 2017-09-21 |
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