CN103096817A - 用于外科缝合器的具有击发锁定的外科缝合头组件 - Google Patents

用于外科缝合器的具有击发锁定的外科缝合头组件 Download PDF

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CN103096817A
CN103096817A CN2011800432724A CN201180043272A CN103096817A CN 103096817 A CN103096817 A CN 103096817A CN 2011800432724 A CN2011800432724 A CN 2011800432724A CN 201180043272 A CN201180043272 A CN 201180043272A CN 103096817 A CN103096817 A CN 103096817A
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surgical stapling
staple
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CN103096817B (zh
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A·O·津格曼
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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
    • A61B17/115Staplers for performing anastomosis in a single operation
    • A61B17/1155Circular staplers comprising a plurality of staples
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical 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
    • A61B17/07207Surgical 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
    • 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
    • A61B17/115Staplers for performing anastomosis in a single operation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/0046Surgical instruments, devices or methods, e.g. tourniquets with a releasable handle; with handle and operating part separable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/0046Surgical instruments, devices or methods, e.g. tourniquets with a releasable handle; with handle and operating part separable
    • A61B2017/00473Distal part, e.g. tip or head
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00477Coupling
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical 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
    • A61B2017/07214Stapler heads
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical 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
    • A61B2017/07214Stapler heads
    • A61B2017/07257Stapler heads characterised by its anvil

Abstract

在多个实施例中,提供了外科缝合头,所述外科缝合头可包括用于支撑一个或多个外科缝钉的钉仓、相对于所述钉仓可动的芯、从所述芯延伸的至少一个缝钉驱动器、和壳体,所述壳体能够至少部分地保持所述钉仓并可动地容纳所述芯和所述缝钉驱动器。所述壳体还可包括至少一个保持构件,所述保持构件能够在向所述保持构件施加足够的外力(例如在将缝合头组件插入于外科缝合器的轴内期间由轴提供外力)时从第一位置运动至第二位置。在所述保持构件处于所述第二位置时可防止所述缝钉驱动器从所述钉仓驱动缝钉,由此在将缝合头组件插入于外科缝合器的至少一部分内期间为缝合头组件提供击发锁定特征。

Description

用于外科缝合器的具有击发锁定的外科缝合头组件
背景技术
本发明实施例总体涉及外科缝合器,并且更具体地讲,涉及包括分立缝钉高度调节的圆形缝合器。
在某些类型的外科手术中,使用外科缝钉已成为连接组织的优选方法,并且因此已开发了用于这类用途的具有特殊构造的外科缝合器。例如,已经开发了用于被称为吻合的外科手术的腔内或圆形缝合器。用于施行这种吻合的圆形缝合器在(例如)美国专利No.5,104,025;5,205,459;5,285,945;和5,309,927、以及美国专利申请序列No.12/408,905中有所公开,这些专利文献均全文引入本文以供参考。
一种类型的吻合包括先切除患病部分然后将肠的各个段连接到一起的外科手术。该手术需要将两个管状部分的末端重新连接到一起,以形成连续的管状通道。以前,这类外科手术既费时又费力。外科医生必须准确切割和对齐肠的两端,并且在通过多次缝合将两端连起来时保持对齐状态。圆形缝合器的开发大大简化了吻合程序,并且也缩短了执行吻合所需要的时间。
一般地,常规圆形缝合器通常由安装于其上的近端驱动机构和远端缝合机构的细长轴构成。远端缝合机构通常包括固定的钉仓,钉仓内含有构造成同心圆阵列的多个缝钉。圆形切刀在缝钉内被同心地安装在钉仓中以用于在其内轴向行进。从钉仓的中心轴向地延伸的是可动的套管针轴,该套管针轴能够将缝钉砧座可脱离地联接到其上。在将缝钉驱入砧座中时,砧座能够使缝钉的末端成形。钉仓远端表面与缝合砧座之间的距离由调节机构控制,而调节机构安装在缝合器轴近端以控制套管针的轴向运动。当外科医生启动驱动机构时,对夹在钉仓和缝合砧座之间的组织同时进行缝合和切割。
通常,在执行外科吻合缝合手术中,两段腔管或管状组织,例如肠组织,通过缝钉环附接在一起。两段管状组织可以端对端附接,或者一段管状组织可以围绕形成在另一段管状组织侧面中的开口横向附接。在用缝合器械执行吻合的过程中,两段管状组织一起被夹在砧座和钉仓之间。缝钉推动器被推进以将缝钉驱入组织中并且抵靠砧座成形缝钉。另外,圆形刀被推进以切割夹在砧座和缝钉夹持器之间的多余组织。因此,组织的环形部分被从每个腔管切断并且保留在砧座轴上。通过朝远端推进砧座轴以使砧座运动远离缝钉夹持器,使通过圆形缝钉环连接的管状组织松开。牵引砧座通过由缝钉环附接的管状组织段之间的圆形开口,从而将缝合器械取出。
此外,使用圆形缝合器执行下部结肠手术时,通常采用常规的外科缝合器缝合肠,这种缝合器在待移除肠的患病部分两侧安置两排缝钉。在缝合相邻末端的同时切除目标段。移除患病部分后,外科医生通常将砧座插入腔管近端,即缝合线近端。这可通过将砧座头部插入外科医生在近腔管切开的入口来完成。有时,砧座可经肛门放置,即通过将砧座头部放在缝合器的远端上并通过直肠插入器械。然后外科医生可用缝线或其他常规的系结装置将肠的近端系在砧座轴上。接着,外科医生切除系结处附近多余的组织,并且外科医生将砧座附接到缝合器的套管针轴上。然后外科医生合拢砧座和钉仓之间的间隙,从而将肠的近端和远端夹紧在间隙中。外科医生随后启动缝合器,从而驱动多排缝钉穿过肠的两端并使其成形,因此接合末端并形成管状通道。同时,在驱动并成形缝钉时,可驱动同心的圆形刀片穿过肠组织末端,从而切割邻近内排缝钉的末端。接着,外科医生从肠中取出缝合器,并完成手术。
在上述外科手术期间,希望在缝钉高度范围内正确地成形缝钉,使得它们保留在组织中并防止渗漏和出血,并且希望实现“组织与组织”接触以促进组织愈合。通常,通过控制砧座和钉仓之间的距离或间隙,可以实现更好的缝合和愈合结果。虽然一些外科缝合器装有指示缝钉高度的可视读出器,但外科医生可能需要在手术期间专注于许多不同的事项。此外,一旦砧座已正确定位,就有必要使砧座在击发期间不运动,否则可能负面地影响正确的缝钉成形。
以上讨论仅仅旨在说明本发明所属领域的现状,而不应视为是对权利要求范围的否定。
发明内容
在多个实施例中,提供了外科缝合头组件。在至少一个实施例中,所述外科缝合头组件可包括用于支撑一个或多个外科缝钉的钉仓、相对于所述钉仓可动的芯、至少一个缝钉驱动器、和壳体,所述至少一个缝钉驱动器用于接合并驱动所述钉仓的缝钉,所述壳体能够至少部分地保持所述钉仓并可动地容纳所述芯和所述至少一个缝钉驱动器。在这些实施例中,所述至少一个缝钉驱动器可从所述芯延伸。此外,在这些实施例中,所述壳体还可包括至少一个保持构件,所述保持构件能够在向所述保持构件施加足够的外力时从第一位置运动至第二位置。此外,在这些实施例中,在所述至少一个保持构件处于所述第二位置时防止所述至少一个缝钉驱动器从所述钉仓驱动缝钉。
在多个实施例中,提供了一种外科缝合器。在至少一个实施例中,外科缝合器可包括主体、缝合头组件、驱动系统、砧座和砧座调节组件。在这些实施例中,主体可包括柄部和从柄部延伸的轴部。此外,在这些实施例中,所述缝合头组件能够可释放地联接到所述轴部。另外,在这些实施例中,所述缝合头组件可包括用于支撑一个或多个外科缝钉的钉仓、相对于所述钉仓可动的芯、至少一个缝钉驱动器、和壳体,所述至少一个缝钉驱动器用于接合并驱动所述钉仓的缝钉,所述壳体能够至少部分地保持所述钉仓并可动地容纳所述芯和所述至少一个缝钉驱动器。此外,在这些实施例中,所述至少一个缝钉驱动器可从所述芯延伸。此外,在这些实施例中,所述壳体还可包括至少一个保持构件,所述保持构件能够在向所述保持构件施加足够的外力时从第一位置运动至第二位置。此外,在这些实施例中,在所述至少一个保持构件处于所述第二位置时防止所述至少一个缝钉驱动器从所述钉仓驱动缝钉。另外,在这些实施例中,所述驱动系统能够向所述缝钉驱动器施加驱动运动。此外,在这些实施例中,所述砧座可相对于所述钉仓被可动地支撑以朝着和远离所述钉仓轴向运动。而且,在这些实施例中,所述砧座调节组件能够选择性地调节所述砧座相对于所述钉仓的轴向位置。
在至少一个实施例中,提供一种外科缝合头组件,其包括用于支撑一个或多个外科缝钉的钉仓、相对于所述钉仓可动的芯、至少一个缝钉驱动器、壳体、和锁定装置,所述至少一个缝钉驱动器从所述芯延伸并用于接合并驱动所述钉仓的缝钉,所述壳体能够至少部分地保持所述钉仓并可动地容纳所述芯和所述至少一个缝钉驱动器,所述锁定装置用于防止所述至少一个缝钉驱动器从所述钉仓驱动缝钉。
附图说明
本申请所述实施例的新颖特征在所附权利要求书中进行了详细描述。然而,关于机构和操作方法的实施例均可以通过参照结合如下附图的以下具体实施方式来更好地理解。
图1是外科缝合器的非限制性实施例的立体图,该缝合器包括圆形缝合头和位于第一位置的砧座。
图2是图1的外科缝合器的立体图,其中示出砧座在第二位置。
图3是图1的外科缝合器的分解图。
图4是图1的外科缝合器的透视图,其中缝合器的主体以虚线显示,以更好地示出主体内的缝合器部件。
图5是图1的外科缝合器的横截面图。
图6是图1的外科缝合器的砧座的后视立体图。
图7A是图1的外科缝合器的缝合头组件的前视立体图。
图7B是图7A的缝合头组件的钉仓的后视立体图;图中显示两个缝钉被从钉仓的缝钉腔中移出。
图7C是图7A的缝合头组件的切割构件和缝钉驱动器的前视立体图。
图8是图1的外科缝合器的砧座调节轴的侧视图。
图9是图8的砧座调节轴的一部分的立体图。
图10A-10C是图8的砧座调节轴的一部分的一系列侧视图,每一幅图示出了当轴围绕其纵向轴线旋转时螺旋表面的行进情况。
图11A-11C是图1的外科缝合器的砧座和缝合头组件的一系列侧视图,每一幅图分别示出了与图10A-10C所示轴位置相关的分立缝钉成形高度。
图12示出了包括参考标记的砧座调节轴的一部分的非限制性实施例。
图13示出了图12的调节轴的一部分中的三个参考标记。
图14是图1的外科缝合器的触发器的后视立体图;所述触发器包括锁定杆。
图15是图3的外科缝合器的一部分的前透视图,示出触发器和锁定杆分别与驱动带和调节轴对接。
图16是包括直的轴部的外科缝合器的非限制性实施例的立体图。
图17是图16的外科缝合器的砧座调节轴的侧视图。
图18是图16的外科缝合器的驱动杆的立体图。
图19是缝合头组件的非限制性实施例的立体图,其中以虚线显示组件的壳体以便更好地示出壳体内的特征。
图20是图19的缝合头组件的侧视图。
图21是图19的缝合头组件的缝钉驱动器芯的立体图。
图22是图19的缝合头组件在初始被插入图1的缝合器的主体内时的局部侧视图,其中以虚线显示缝合器的主体,以更好地示出位于缝合器主体内的缝合头组件的部分。
图23是图19的缝合头组件在被进一步插入图1的缝合器主体内时的局部立体图,其中以虚线显示缝合器的主体以及缝合头组件的壳体,以更好地示出其中的各种特征。
图24是图19的缝合头组件在被完全插入图1的缝合器主体内时的局部立体图,其中以虚线显示缝合器的主体,以更好地示出其中的部件。
图25是包括切割构件的缝合头组件的非限制性实施例的立体图,其中以虚线显示组件的壳体以便更好地示出壳体内的特征。
图26是图25的缝合头组件的侧视图。
具体实施方式
现在将描述某些实施例,以提供对本发明所公开的结构、功能、制造的原理、以及设备和方法的使用的全面理解。这些实施例的一个或多个实例在附图中示出。本领域普通技术人员将会理解,本文具体描述并在附图中示出的装置和方法是非限制性的实施例,并且这些实施例的范围完全由权利要求书来限定。关于一个实施例所例示或描述的特征可与其他实施例的特征进行组合。此外,当指出某一方法中的步骤顺序时,根据需要,这样的顺序可以重新安排,或者步骤可以同时进行,除非不合逻辑或明确地要求使用所列出的顺序。这样的修改形式和变型形式旨在纳入所附权利要求书的范围内。
在下面的描述中,在若干视图中,相同的附图标记指示相同或对应的部件。另外,在下面的描述中,应当理解,诸如“向前”、“向后”、“前”、“后”、“右”、“左”、“在...上方”、“在...下方”、“向上”、“向下”、“向近端”、“向远端”等词是方便型用语,不应认为是限制性术语。下面的描述是为描述各种实施例之目的,并非意图限制所附权利要求。
各种实施例总体上涉及各种外科缝合器,其能够密封组织,并且在至少一个实施例中也可切割组织。此类外科缝合器能够通过诸如肛门、口腔和/或阴道之类的天然孔口或通过切穿体壁的切口工作。此外,此类外科缝合器可设计成内窥镜式工具,包括腹腔镜式工具。一种示例性类型的外科缝合器可见于共同未决的美国专利申请No.12/635,415,其名称为“进行分立的缝钉高度调节的圆形外科缝合器(CIRCULAR SURGICALSTAPLER WITH DISCRETE STAPLE HEIGHT ADJUSTMENT)”且提交于2009年12月10日,该美国专利申请的全文以引用的方式并入本文。
现在关注非限制性实施例,如图1-4中所示,提供了圆形缝合器1,其包括管状或圆形主体10、可操作地联接到主体10的缝合头30、砧座50、由主体10支撑的砧座调节轴70、以及可动地联接到主体10的触发器90。砧座50可相对于缝合头组件被可动地支撑,以便进行朝着和远离缝合头30的选择性行进。此外,砧座调节轴70可由主体10支撑,以选择性地调节砧座相对于缝合头的位置。因此,如下面将进行的更详细的说明,调节轴70可以可操作地联接到砧座50以使砧座运动。例如,调节轴70可经由调节轴的旋钮79围绕其纵向轴线在第一旋转方向(例如顺时针“CW”方向)上旋转,以使轴70和砧座50在远端方向“DD”上相对于主体10从图1所示第一位置运动或平移至图2所示第二位置。同样,调节轴70可以在第二旋转方向(例如逆时针方向“CCW”)上旋转,以使轴70和砧座50在近端方向“PD”上相对于主体10从图2所示第二位置运动或平移至图1所示第一位置。应当理解,砧座50可位于在图1-2所示位置之间或以外的外科缝合器1允许的任何位置。此外,在至少一个实施例中,如下面将进行的更详细的说明,调节轴70能够将砧座50运动至离缝合头至少一预定距离处和/或向使用者提供触觉反馈。
当触发器90被启动时,驱动系统可在主体10内被启动,以使缝钉31(参见图3和图7B)可从缝合头30被排出,以与砧座50成形接触。同时,可操作地支撑在头部30内的切割构件32(参见图7C)将对保持在被缝合组织周围靠里的组织进行切割。然后将缝合器10从组织中拔出,将被缝合的组织保持在原位。此外,触发器90可包括弹簧91,弹簧91从杠杆92延伸,使得当杠杆92被挤压或以其他方式围绕铰链销93朝主体10运动时,杠杆91受偏压远离主体10向后,并且刀70在杠杆92释放时自动回缩。
参见图3,主体10可包括柄部11和弯曲轴部12。虽然本实施例示出了弯曲轴部12,但该轴部也可以是直的或线性的(参见例如下面讨论的图16)。柄部11可适于经由鞍形附件13容纳触发器90,鞍形附件13还可包括用来容纳铰链销93的孔16(参见图3),铰链销93也可容纳在触发器90的孔96中。柄部11可进一步限定位于主体10顶部的开口14,通过开口14可以定位触发器90的一部分。例如,凸轮表面94和锁定杆95可延伸通过开口14。如下面将进行的更详细的说明,凸轮表面94能够当触发器90相对于柄部11运动时启动驱动系统,以及在砧座50处于合适位置使得缝钉可在砧座50和缝合头30之间成形之前,锁定杆95可防止切割构件32和/或缝钉31意外击发。
参见图3和4,驱动系统可包括驱动带80,驱动带80位于主体的轴部12内部,在触发器的凸轮表面94和缝合头30的接片36之间轴向延伸。驱动带80可包括近端驱动表面81和远端驱动表面82。因此,启动触发器可使凸轮表面94旋转并推动近端驱动表面81,使得驱动带80在轴向上朝着或远离砧座50运动。缝合头的接片36可联接在驱动带的远端驱动表面82内,远端驱动表面82可采用凹口的形式以便可释放地容纳接片36。
参见图4和7A-7C,缝合头30可包括组件,该组件包括:钉仓33,其用于支撑一个或多个缝钉31;至少一个缝钉驱动器34,用于接合和驱动来自钉仓33的缝钉31;以及切割构件32(例如刀),其可动地支撑在缝合头30中。在至少一个实施例中,缝钉驱动器34和切割构件32可以一体地连接和/或形成。例如,缝钉驱动器34和切割构件33可从芯35中伸出,并且二者都可由相同材料形成。在任何情况下,驱动带80朝向钉仓33和/或砧座50的动作均可引起缝合头的接片36(可从芯35中伸出),以及切割构件32和缝钉驱动器34朝砧座50运动。此外,缝合头30也可包括壳体39,该壳体能够保持钉仓33并在其内可动地容纳缝钉驱动器34、切割构件32,和/或芯35。壳体39还可包括释放按钮37,该释放按钮能够柔性地挠曲并允许缝合头30在形成于主体轴部12中的对应孔15(参见图3)处可释放地附接到主体的轴部12。因此,参见图4,缝合头30可通过以下方式移走:按下按钮37,然后转动头部30,使得接片36从由驱动带80的远端驱动表面82形成的凹口中脱开,最后将缝合头30拉离主体10。
现在关注砧座50的调节,参见图3,在多个实施例中且如上所指,砧座50可相对于钉仓33被可动地支撑,使得砧座可以朝着和远离钉仓33轴向运动。更具体地,外科缝合器1可包括用于选择性地调节砧座50相对于钉仓33的轴向位置的砧座调节组件。砧座调节组件可包括调节轴70和套管针73,该套管针联接到调节轴70,以与调节轴70一起行进。调节轴70可包括近端部分70a和远端部分70b,这两个部分可以连接到一起以形成轴70。作为另外一种选择,近端部分70a和远端部分70b可由同一件材料一体和整体地形成(参见例如图17所示的调节轴170,以及下面的讨论)。另外,调节轴70还可包括位于远端部分70b处的环形凹槽71,该环形凹槽可以被夹住或以其他方式自由连接到砧座调节带72的近端。应当理解,“自由连接”是指在调节轴70旋转时调节带72可不旋转;然而,调节带72仍可以与轴70一起平移。调节带72的远端也可附接到套管针73。因此,调节轴70相对于主体10的轴向运动或平移可使套管针73也相对于主体10轴向运动或平移。
参见图3和4,砧座调节带72和驱动带80中的一者或两者可分别包括接片83和84,这两种接片均弯曲或以其他方式伸向主体10。接片83、84可帮助使带72、80能够行进通过主体的弯曲轴部12,同时填充空间并在其内保持合适的轴向位置。
此外,参见图3和6,如本领域已知,套管针73可通过联接到砧座和/或套管针的簧片或弹簧夹55可脱离地附接到砧座50。换句话讲,通过按压、拉拔或以其他方式操纵弹簧夹55,可从套管针中移开砧座。反之,通过使套管针运动进入砧座,使得弹簧夹55将砧座可释放地保持在套管针上,可将套管针按扣入砧座中。因此,砧座调节轴70相对于主体10的轴向运动也可以相对于主体10轴向运动或平移砧座50。此外,砧座也可包括联接到砧座主体52的护盖53(参见图3)和在击发切割构件32期间被剪切的垫圈54,如上面所讨论。垫圈54可由塑料制成并可充当切割表面,组织可以抵靠该表面被切断。
现在参见图3-5,砧座调节轴70能够进行旋转(如上面所述),使得轴70相对于主体10平移。更具体地并且在至少一个实施例中,砧座调节轴70可包括螺旋表面74,该螺旋表面可操作地与主体10的接合部(例如,通过主体中的孔固定到主体10的螺销75)接合。螺旋表面74可由形成于调节轴70中的槽限定,所述槽被构造成并且其尺寸被设定成在其内容纳销75的至少一部分。砧座调节轴70可围绕其纵向轴线L旋转(参见图8),使得螺旋表面74接触并在销75上方运动,从而使砧座调节轴70相对于主体10平移。虽然在本实施例中描述了销75,但可以使用任何其他合适的螺纹配合部分或部件(例如突起、螺纹等)来代替或辅助销75接合螺旋表面。在任何情况下,使调节轴70围绕其纵向轴线旋转可以导致轴70,继而套管针73和砧座50也相对于主体10和/或缝合头30轴向平移或运动。
如上面所提及,在多个实施例中,调节轴70能够使砧座50运动至离缝合头30至少一个预定距离处。更具体地,现在关注图8,其仅示出调节轴70,调节轴的螺旋表面74可包括至少一个斜坡部分和至少一个停顿部分。例如,螺旋表面74可包括第一斜坡部分74a和一个或多个第二停顿部分74b。至少一个限定器,例如限定器76,也可将斜坡部分74a与停顿部分74b分开。如下面将进行的更详细的讨论,斜坡部分74a可允许调节轴相对于主体10平移(参见图4),停顿部分74b可提供预定距离以维持砧座50距缝合头30的位置(参见图2),并且限定器76可向旋转砧座调节轴70的使用者提供触觉反馈以及斜坡部分和停顿部分之间的过渡。此外,在至少一个实施例中,斜坡部分74a可以在形状上至少部分是螺旋状。
接着,图8中以虚线画出的圆表示图9和10A-10C中所示砧座调节轴70的近侧端部分。现在关注图9,螺旋表面74的斜坡部分74a可引导进入至少一个停顿部分。如图所示,并且在至少一个实施例中,螺旋表面74还可包括三个停顿部分:第一停顿部分74b'、第二停顿部分74b''和第三停顿部分74b'''。砧座调节轴70围绕其纵向轴线的旋转可使螺旋表面74沿销75而过(参见图5),使得轴70相对于主体10平移(再次参见图5)。此外,当轴70按(例如)顺时针CW旋转时,螺旋表面74可以沿销75运动,使得销75接触斜坡部分,然后接触第一停顿部分74b'。然后,当轴70再次顺时针CW旋转时,该销可以接触第二停顿部分74b''。之后,轴70按顺时针CW方向继续旋转可使该销接触第三停顿部分74b'''。如下面将进行的更详细的说明,每个停顿部分可以相对于斜坡部分74a处于不同角度构造处。
此外,每个停顿部分74b'、74b''和74b'''可位于沿砧座调节轴70的不同纵向位置处,以提供预定的分立缝钉成形高度。例如,参见图10A,第一停顿部分74b'可位于距轴组件的横向凸缘77为第一距离L1处。第二停顿部分74b''可位于距横向凸缘77第二距离L2处,而第三停顿部分74b'''可位于距横向凸缘77第三距离L3处。包括横向凸缘77的任何参考点或参考平面可用于建立上述距离。在任何情况下,第一距离L1可以大于第二距离L2,第二距离可以大于第三距离L3,或者L1>L2>L3。作为另外一种选择,尽管图中未示出,然而这些距离可为其他比较次序,例如L1>L3>L2,L2>L1>L3,L2>L3>L1,L3>L2>L1,或者L3>L1>L2。此外,在相应停顿部分74b'、74b''和74b'''上的各停顿距离L1、L2和L3可以是均匀的。换句话讲,例如参见图10B,在螺旋表面的斜坡部分74a可相对于调节轴的纵向轴线L以小于90度的斜坡或螺旋角α倾斜的同时,每一停顿部分(例如图10B中的74b'')可基本上垂直于纵向轴线L,或者相对于轴线L限定近似90度的夹角θ。此外,参见图9和图10A-10C,停顿部分74b'、74b'、74b'''也可为用于限定预定的分立缝钉高度的台阶,如下文所述。当测量相对于纵向轴线L的上述角度时,应当理解,此类测量可以相对于这样的平面进行:该平面与螺旋表面74的一部分以及该平面与纵向轴线L相交的点相切,为了清晰起见,纵向轴线L沿图10A-10C中所示砧座调节轴的整个长度显示。例如,再次参见图10B,螺旋角度α在切平面“TP”和纵向轴线L之间限定,其中该切平面垂直于图10B所在的纸面平面。
现在关注图11A-11C,缝合头30和砧座50显示处于与轴的螺旋表面的停顿部分74b'、74b''和74b'''相关联的多个位置。例如,分立的缝钉成形高度D1、D2和D3可以限定于砧座50的缝钉成形表面51和钉仓33的缝钉弹出表面38之间。第一高度D1可以大于第二高度D2,第二高度可以大于第三高度D3,或者D1>D2>D3。同时参见图10A-10C和11A-11C,在旋转调节轴70的同时,每个停顿部分74b'、74b''和/或74b'''可允许砧座50保持在相应的缝钉成形高度D1、D2和/或D3处,使得停顿部分沿销75运动(参见图5)。例如,每个停顿部分74b'、74b''、74b'''可设计成在轴旋转约60度的时间段内保持砧座的位置。换句话讲,沿每个停顿部分的表面延伸的弧可以在大约60度的角度范围内延伸。
参见图9和10A-10C,在多个实施例中,至少一个过渡部可以分开每个停顿部分74b'、74b''和/或74b''',从而使得砧座调节轴70能够相对于销75前进到另一个位置(参见图5)。在至少一个实施例中,过渡部可包括另一个斜坡部分和/或部分螺旋表面。然而,在至少一个其他实施例中,过渡部也可包括至少一个限定器。如图10A-10C中可见,第一限定器76'可将螺旋表面的斜坡部分74a与第一停顿部分74b'分开,第二限定器76''可将第一停顿部分74b'与第二停顿部分74b''分开,第三限定器76'''可将第二停顿部分74b''与第三停顿部分74b'''分开。如上所述,每个限定器76'、76''和/或76'''可在使用者旋转砧座调节轴的同时向使用者提供触觉反馈。
更具体地,再次参见图9和10A-10C,每个限定器76'、76''和/或76'''可包括位于螺旋表面中的凸耳或突起。换句话讲,螺旋表面74可限定包括斜坡部分74a与停顿部分74b'、74b''和74b'''的表面形貌,并且每个限定器76'、76''和/或76'''可以是分别位于上述部分之间的表面形貌中的中断部。另外,除了限定器76'、76''和/或76'''之外,位于螺旋表面74的任何部分上的表面形貌都可以是平滑的。例如,参见图5、9和10A-10C,螺旋表面的斜坡部分74a可包括平滑形貌,使得当砧座调节轴70相对于主体10旋转时,螺旋表面74可以相对平滑地运动经过销75。然而,当销75到达斜坡部分74a的末端时,表面形貌可以被第一限定器76'中断。因此,当螺旋表面74在销75上方前进,伴随第一限定器76'接触销75(这归因于螺旋表面74的表面形貌在限定器76'处的中断),调节轴70(当轴70旋转时,其可以由近端以平滑的方式从主体10中延伸)可以不连贯或不连续的方式跳动、推动或拉动,或以其他方式向使用者提供触觉反馈。第一限定器76'在销75上方经过的动作可以向对轴70进行旋转的使用者提示销75此时已容纳在第一停顿部分74b'处,因而第一分立的缝钉成形高度D1(参见图11A)已达到。轴70在停顿期(如上所述,可以为大约60度)内的连续旋转可并不调节第一缝钉成形高度D1。因此,使用者不一定需要关注砧座调节轴70所处的准确旋转位置,只要使用者知道第一缝钉成形高度D1在轴70被进一步旋转以使另一个限定器接触销75之前将不会改变即可。此外,使用者可以来回旋转砧座调节轴70,使得销75沿着第一停顿部分74b'在第一限定器76'和第二限定器76''之间相对运动。因为限定器从第一停顿部分74b'的表面突出,当销75接触位于第一停顿部分74b'相应末端处的第一限定器76'或第二限定器76''时,使用者通过砧座调节轴70可以感觉到,从而让使用者确信已经到达第一缝钉成形高度D1
参见图5、9和10A-10C,如果使用者希望将缝钉成形高度从第一缝钉成形高度D1改变为第二缝钉成形高度D2(参见图11A-11B),则使用者可以进一步旋转砧座调节轴70,使得第二限定器76''接触销75。当销75到达第一停顿部分74b'的末端时,表面形貌可被第二限定器76''中断。因此,当螺旋表面74在销75上方前进时,伴随第二限定器76''接触销75(这归因于螺旋表面74的表面形貌在限定器76'''处的中断),调节轴70(在销75接触第一停顿部分74b'期间,其可以平滑地旋转)可以不连贯或不连续的方式跳动、推动或拉动,或以其他方式向使用者提供触觉反馈。第二限定器76''在销75上方经过的动作可以向旋转轴70的使用者提示销75此时已容纳在第二停顿部分74b''处,因而第二分立的缝钉成形高度D2(参见图11B)已达到。轴70在停顿期(如上所述,可以为大约60度)内的连续旋转可并不调节第二缝钉成形高度D2。因此,使用者不一定需要关注砧座调节轴70所处的准确旋转位置,只要使用者知道第二缝钉成形高度D2在轴70被进一步旋转以使另一个限定器接触销75之前将不会改变即可。此外,使用者可以来回旋转砧座调节轴70,使得销75沿着第二停顿部分74b''在第二限定器76''和第三限定器76'''之间相对运动。随着限定器从第二停顿部分74b''的表面突出,使用者通过砧座调节轴70可以感觉到销75何时接触位于第二停顿部分74b''相应末端处的第二限定器76''或第三限定器76''',从而让使用者确信已经到达第二缝钉成形高度D2
相似地,仍然参见图5、9和10A-10C,如果使用者希望将缝钉成形高度从第二缝钉成形高度D2改变为第三缝钉成形高度D3(参见图11B-11C),则使用者可以进一步旋转砧座调节轴70,从而使第三限定器76'''接触销75。当销75到达第二停顿部分74b''的末端时,表面形貌可以被第三限定器76'''中断。因此,当螺旋表面74在销75上方前进时,伴随第三限定器76'''接触销75(这归因于螺旋表面74的表面形貌在限定器76'''处的中断),调节轴70(在销75接触第二停顿部分74b''的同时,其可以平滑地旋转)可以不连贯或不连续的方式跳动、推动或拉动,或以其他方式向使用者提供触觉反馈。第三限定器76'''在销75上方经过的动作可以向对轴70进行旋转的使用者提供指示,以提示销75此时已容纳在第三停顿部分74b'''处,因而第三分立的缝钉成形高度D3(参见图11C)已达到。轴70在停顿期(如上所述,可以为大约60度)内的连续旋转可并不调节第三缝钉成形高度D3。因此,使用者不一定需要关注砧座调节轴70所处的准确旋转位置,只要使用者知道第三缝钉成形高度D3在轴70被进一步旋转以使阻挡件78接触销75、从而防止销75相对于螺旋表面74朝阻挡件78进一步运动之前将不会改变即可。阻挡件78可以是形成在第三限定器部分74b'''末端处的壁。此外,使用者可以来回旋转砧座调节轴70,使得销75沿着第三停顿部分74b'''在第三限定器76'''和阻挡件78之间相对运动。因为阻挡件和限定器76'''从第三停顿部分74b''的表面突出,当销75接触位于第三停顿部分74b'''相应末端处的第三限定器76'''或阻挡件78时,使用者通过砧座调节轴70可以感觉到,从而让使用者确信已经到达第三缝钉成形高度D3
在多个实施例中,参见图9和15,例如,螺旋表面74可以在斜坡部分74a闭合,而在停顿部分74b'、74b''、74b'''打开。换句话讲,螺旋表面的斜坡部分可包括近端壁和远端壁,而螺旋表面的停顿部分可仅包括近端壁。在使用中,销75可受偏压抵靠停顿部分,这是由于当砧座50位于距离头部30合适的缝钉成形高度处时,组织被夹在砧座50和缝合头30之间,如上面所讨论(参见图11A-11C)。
虽然以上所述至少一个实施例示出限定器76'、76''和/或76'''成形为螺旋表面74中的凸耳或突起,但限定器也可以采用位于螺旋表面中的缺口的形式。另外,限定器可以是与调节轴70分开的部件,使得它们可以附接到调节轴70。在任何情况下,当使用者旋转轴70时,限定器可以向使用者提供触觉反馈。此外,虽然限定器显示为将斜坡部分74a与第一停顿部分74b'等分开,但螺旋表面可以不包括一个或多个停顿部分。在此类实施例中,螺旋表面可包括被至少一个限定器以所需间隔分开的多个斜坡部分。因此,当砧座50和钉仓33之间(参见例如图11A)已经获得合适的缝钉成形高度时,使用者可以通过触觉反馈获知。
除了触觉反馈之外,外科缝合器1可包括可视参考标记,用以在达到缝钉成形高度时向使用者提示。例如,现在参见图12-13,砧座调节轴70可包括印刷或成形在轴表面上的参考标记85,该参考标记通过主体10上的标志86而在已达到诸如D1、D2、D3(参见图11A-11C)的分立缝钉成形高度时,提供相应指示。在至少一个实施例中,相应的缝钉成形高度可以是2.5mm、1.8mm和1.0mm,并且参考标记85可以指示这些高度。在任何情况下,将如上面所讨论的可视标记、限定器和/或停顿部分结合到砧座调节轴70中,可以不再需要与轴分开的缝钉高度指示机构。
另外,虽然以上所述至少一个实施例已经将螺旋表面74示出为由形成于砧座调节轴70中的槽限定,但作为另外一种选择,在至少一个实施例中,螺旋表面可由从砧座调节轴70突出的螺纹限定。在此类实施例中,可以采用销75,或者可以使用另一个螺纹配合部件来啮合螺旋表面,例如,从主体10内部伸出的叉状物。
此外,虽然上面讨论的螺旋表面74被描述作为砧座调节轴70的一部分,但应当理解,作为另外一种选择,这样的螺旋表面可作为主体10的一部分。在此类实施例中,诸如销或其他螺纹配合部件的接合部将同样被固定到调节轴70,而不是固定到主体10。在任何情况下,轴70的旋转可使螺旋表面相对于接合部旋转,使得轴70,继而砧座50相对于主体10和/或缝合头30平移。
在多个实施例中,如上面所提及并参见图5,在砧座50处于离钉仓33适当距离处之前,触发器90可与调节轴70配合,以防止触发器90实质上朝主体10运动,或换句话说,防止导致缝钉驱动器34和/或切割构件32被启动,从而防止外科缝合器1的意外击发。换句话讲,触发器可包括锁定器。例如,在至少一个实施例中并参见图8,致动轴70可包括限定第一宽度W1的第一近端部分70a和限定第二宽度W2的第二远端部分70b。此外,参见图14,触发器90可包括从杠杆92延伸的锁定杆95,杆95限定开口97,开口97的尺寸为S。锁定杆可类似于具有两个尖头的叉或者类似于托架。在任何情况下,开口97的尺寸S可小于近端部分70a的第一宽度W1,但开口97的尺寸S可大于或等于远端部分70b的第二宽度W2,或者W1>S≥W2
现在参见图15,锁定杆95可以被布置成通过主体开口14,使得杆95可操作以接合轴的近端部分70a或者轴的远端部分70b。如果锁定杆95纵向地被布置在近端部分70a上方,则触发杠杆92会由于锁定杆95和轴的近端部分70a之间的干扰作用而被阻止实质上朝主体10运动。换句话讲,由于近端部分的宽度W1(参见图8)大于锁定杆开口97的尺寸S(参见图14),可以防止触发杠杆92引起驱动带80启动,如上面所述,从而防止缝钉31和/或切割构件32意外击发(参见图3)。然而,如果锁定杆95纵向地被布置在远端部分70b上方,则触发杠杆92会由于锁定杆95和轴的远端部分70b之间没有干涉作用而被允许实质上朝主体10运动。换句话讲,由于远端部分的宽度W2(参见图8)小于或等于锁定杆的开口97的尺寸S(参见图14),可以允许触发杠杆92运动并导致驱动带80启动,如上面所述,从而击发缝钉31和/或切割构件32(参见图3)。在此类实施例中,开口97可容纳轴的远端部分70b并允许杠杆92朝主体10运动,直到远端部分70b到达开口97的末端。
此外,参见图15,轴的远端部分70b可以沿砧座调节轴70定位,使得远端部分70b与合适的缝钉成形高度相关联。例如,远端部分70b可以沿轴70轴向布置,使得当销75被容纳在停顿部分(例如第一停顿部分74b')中时,锁定杆95纵向地布置在远端部分70b上方。因此,锁定杆95可以在已达到所需缝钉成形高度时仅允许缝钉驱动器34和/或切割构件32(参见图3)被击发,而不需要与触发器90分开的锁定杠杆或机构。此外,参见图14,锁定杆95可以由与触发器弹簧91相同的同一块材料一体和整体地形成。然而,在至少一个实施例中,锁定杆95、触发器弹簧91和杠杆92可以由同一块材料一体和整体地形成。
在多个实施例中,并且如上面所提及,外科缝合器可以是直的,而不是如上所述弯曲的。因此,现在参见图16,其中示出了一种外科缝合器101。外科缝合器101可包括类似于上面所述的主体110、缝合头130、砧座150、砧座调节轴170和触发器190。然而,主体110的轴部112可以是直的。此外,缝合头130和砧座150可以是线性的,并且远离主体110轴向地伸出。应该指出的是,参见图1和16中分别示出的外科缝合器1和外科缝合器101,由于各缝合头30、缝合头130如上所述可从外科缝合器主体10、外科缝合器主体110移除,缝合头30、缝合头130和砧座50、砧座150可以例如彼此互换。除了上述头部30、头部130和砧座50、砧座150之外,还可以采用其他缝合头构造和砧座构造。
另外,现在参见图17,砧座调节轴170和套管针173可以由同一块材料一体和整体地形成。因此,轴的远端部分170b可从近端部分170a伸出并邻接套管针173。此外,参见图18,其中示出了驱动杆180。驱动杆可允许触发器190(参见图16)运动以朝缝合头130启动驱动杆180,以从中弹出缝钉和/或启动切割构件(未示出)。简而言之,驱动杆可以是细长的通常为管状的形状,并且包括近端驱动表面181和远端驱动表面182。参见图16和18,近端驱动表面181能够容纳来自触发器190的驱动,而远端驱动表面182能够在缝合头130内接合缝钉驱动器和/或切割构件(未示出),如上所述。另外,驱动杆180可包括通道187,该通道能够容纳穿过其中的砧座调节轴170(参见图17)。在至少一个实施例中,缝合器101可以不包括切割构件,并且可以主要用来缝合或密封组织,而不是横切组织。
应当理解,以上讨论的直缝合器101和弯曲缝合器1(分别参见图16和图1)可包含比市场上可获得的类似现有外科缝合器明显更少的部件。例如,参见直外科缝合器101,特别是参见砧座调节轴,将旋钮179与闭合螺钉或螺旋表面174以及套管针173组合成一个整体部件砧座调节轴170减少了外科缝合器的部件数。通过将斜坡部分174a与停顿部分174b组合成螺旋表面174,可进一步减少部件数。如上面所讨论,螺旋表面的斜坡部分174a可允许轴170相对于主体110的初始快速轴向运动,而停顿部分174b可以在砧座150和缝合头130之间建立至少一个分立的预定缝钉成形高度。总体上,忽略砧座和缝合头部件,相比现有装置中三十个以上的部件,外科缝合器101可以仅包括七个部件。参见图16-18,这七个部件可包括主体110、击发触发器190、将触发器190可枢转地联接到主体110的铰链销193、与锁定杆195一体形成的触发器弹簧191、砧座调节轴170、可操作地接合轴的螺旋表面174的螺销(未示出,参见例如图3所示的螺销75)以及驱动杆180。另外,可以进一步减少部件数。例如,通过将例如铰链止动装置或柔性接片组合到触发器190自身中,即可以取消铰链销193。此外,弹簧191和锁定杆195也可与触发器190一体形成。另外,通过加入从主体110内表面延伸的突起,使得螺旋突起可以接合螺旋表面174,从而可以取消螺销(未示出)。在任何情况下,外科缝合器101的前述部件可以提供与上面所述类似的功能。这种仅使用少许制造技术的简化的缝合器结构可以广泛地应用,并应适用于多用途可消毒装置,该装置相比类似的目前可用的外科缝合器成本明显更低,并且所需制造时间更少。因此,在至少一个实施例中,可以提供包括上述部件而减少砧座和缝合头部件的可重复使用的缝合器。此外,在至少一个实施例中,包括钉仓的砧座和/或缝合头也可以是一次性的。
在至少一个示例性实验中,通过将每个部件与部件标准列表进行对比以查看是否需要该部件,实现上述部件数的最少化。剩下的仅是以上列出和出于组装原因而需要的部件、具有独特材料性质的部件,或者相对于缝合器中其他部件运动的部件。
在多个实施例中,缝合头组件能够包括锁定特征,以便在插入至外科缝合器的一部分内期间,阻止或防止缝钉驱动器意外从钉仓击发或驱动缝钉。更详细地说,现在参见图19-20,缝合头组件230可大体类似于上述的缝合头30和/或130,从而使缝合头组件230可例如用作外科缝合器1和/或101的元件。换句话讲,缝合头组件230可如上文分别针对缝合头30和130所述而被插入至轴12或112中。
因此,更详细地说,缝合头组件230可包括钉仓233、芯235、从芯235延伸的至少一个缝钉驱动器234、和壳体239,钉仓233用于支撑一个或多个外科缝钉(图中未示出;然而,例如参见图7B中的缝钉31),芯235可相对于钉仓233活动,壳体239能够至少部分地保持钉仓233并可动地容纳芯235和缝钉驱动器234。如上文所述,缝钉驱动器234可从钉仓接合并驱动缝钉。
参见图21,在至少一个实施例中,缝钉驱动器234和芯235可以一体地连接和/或形成。例如,各缝钉驱动器234可可操作地联接到芯235,每一缝钉驱动器均可由相同的材料形成,例如由塑料材料形成。接片236可自芯上突出,这些接片236能够接合驱动带80或驱动杆180(分别参见图4和图18)。在任何情况下,如同例如上述缝合头30一样,驱动带80或驱动杆180的致动可致使芯235并进而使缝钉驱动器234击发,从而从钉仓233驱动或弹出缝钉。
如图20所示,在至少一个实施例中,壳体239可另外包括至少一个保持构件237,保持构件237能够弹性地和/或挠性地使缝合头30偏转并使缝合头30能够例如在形成于主体的轴部12中的对应孔15(参见图3)处可释放地附接到主体的轴部12。每一保持构件237可还包括释放按钮,例如如图19-20所示。因此,当被插入于缝合器主体10(图3)的轴部12中时,缝合头组件230(图19)可通过以下方式移走:按下各保持构件237上的相应按钮,然后转动头部30,使得接片36从由驱动带80的远端驱动表面82形成的凹口中脱开,最后将缝合头组件230拉离主体10。
如在下文中所更详细说明,当对保持构件施加足够的外力(例如在将缝合头组件插入至轴内期间由外科缝合器1(参见图4)的轴部12提供)时,保持构件237能够从第一位置运动至第二位置。第一位置可以是未被按下位置,而第二位置可以是被按下位置,在第二位置上,保持构件237既可接触也可不接触芯235。当保持构件237处于第二位置时,可防止缝钉驱动器234从钉仓233驱动或弹出缝钉,由此在将缝合头组件230插入于外科缝合器的至少一部分内期间为缝合头组件230提供击发锁定特征。
在至少一个实施例中,为使缝合头组件230具有额外的锁定能力,芯235还可包括凹槽240,凹槽240被构造成并且其尺寸被设定成在保持构件237处于第二位置时容纳保持构件237。例如,参见图21,凹槽240可设置于芯235的表面中,且凹槽240可限定于例如两个侧壁241与242之间。在此种实施例中,至少部分地由于被按下的保持构件237与侧壁241、242之间的干涉、和/或至少部分地由于被按下的保持构件237与芯235的表面之间的摩擦,可在保持构件237被按下至凹槽240中时防止芯235以及进而防止缝钉驱动器234相对于壳体239(参见图19)运动。
如上文所述,在多个实施例中,保持构件237可弹性地偏转。换句话讲,保持构件237可弹性地偏转,从而在因受到外力而偏转之后,保持构件237可回弹或以其他方式返回至其原始位置。更详细地说,各保持构件237可分别包括形成于壳体239中的悬臂。在此种实施例中,参见图19,悬臂式保持构件可围绕由壳体235所限定的纵向轴线“L”弯曲,以例如与外科缝合器1(参见图4)的管状主体10的曲率相关联。换句话讲,保持构件237可如图19所示围绕钉仓壳体沿径向弯曲或卷曲。作为另外一种选择,保持构件可为线性的或在与壳体239所限定的纵向轴线L平行的方向上延伸。
在至少一个实施例中,保持构件237可为一体的并与壳体239形成一体,从而使壳体239与保持构件237由同一件材料形成和/或模制而成。在此种实施例中,壳体239可由塑料材料制成,例如由尼龙、聚碳酸酯、聚醚酰亚胺(PEI)或聚醚醚酮(PEEK)制成。另外,在至少一个实施例中,芯可由塑料材料制成,例如由尼龙、聚碳酸酯、聚醚酰亚胺(PEI)或聚醚醚酮(PEEK)制成。
在至少一个实施例中,可参照图22-24来理解与芯235和/或凹槽240相互作用的保持构件237的操作。图22示出缝合头组件230的一部分被初始地插入圆形缝合器的主体10的轴部12中。主体10是以虚线进行显示,以更好地示出缝合头组件230的位于缝合器主体内的部分。保持构件237可分别包括斜面243,由图可见,在轴部12即将接触保持构件237的斜面243之前,保持构件237仍处于未偏转位置或第一位置。沿近端方向“PD”进一步推进缝合头组件可使轴部12接触保持构件237并开始使保持构件237朝芯235向内偏转。图23示出缝合头组件230被进一步插入于圆形缝合器的主体中。由图可见,圆形主体10的内壁使保持构件237保持于被按下位置或第二位置。在被按下位置或第二位置上,保持构件237可被容纳于凹槽240(参见图21)中,以由此防止芯235沿远端方向“DD”运动。另外,例如凹槽侧壁241可防止保持构件237沿远端方向DD明显地运动。通过使缝合头组件进一步沿近端方向PD(参见图22)运动并接着使保持构件237的释放按钮对准主体10中的孔15,可允许保持构件弹性地返回至未被按下位置,从而使保持构件237不仅将缝合头组件230保持于圆形缝合器主体10中、而且还使凹槽240和/或侧壁241、242通畅以便能够致动芯235和缝钉驱动器234并从钉仓233(参见图19)驱动缝钉。例如,图24示出被完全插入于圆形缝合器主体10中的缝合头组件230,其中保持构件237处于此种未被按下位置并至少部分地位于孔15内。此外,如图24所示,芯的接片236被容纳于驱动带80的凹口中,以容纳来自驱动带80的致动运动,此类似于上文关于例如缝合头30(参见图4)所述。
缝合头组件的其他型式可包括上文所述的各种特征。例如,在至少一个实施例中并参见图25-26,缝合头组件330可关于纵向轴线“L”而大体径向对称。然而,在此种实施例中,缝合头组件330可在其他方面类似于例如上文所述的缝合头组件230和/或缝合头30。例如,缝合头组件330可包括用于支撑一个或多个外科缝钉的钉仓333、相对于所述钉仓333可动的芯335、从所述芯335延伸的至少一个缝钉驱动器334、和壳体339,所述壳体339能够至少部分地保持所述钉仓333并可动地容纳所述芯335和所述至少一个缝钉驱动器334。缝钉驱动器334能够从钉仓333接合并驱动缝钉。另外,所述壳体还可包括至少一个保持构件337,所述保持构件337能够在对保持构件337施加足够的外力时从第一位置运动至第二位置。进一步,当保持构件337处于第二位置时可防止所述至少一个缝钉驱动器从钉仓驱动缝钉。在至少一个实施例中,所述芯还可包括凹槽340,凹槽340被构造成并且其尺寸被设定成在保持构件337处于第二位置时容纳保持构件337。另外,不同于缝合头组件230,组件330还可包括切割构件332,切割构件332可操作地联接到芯335。因此,当保持构件处于被按下位置以防止芯335相对于壳体339运动时,也可防止切割构件332和/或缝钉驱动器334相对于壳体339运动,从而防止切割构件332和/或钉仓333中的缝钉被意外击发。另外,芯335可包括从芯335沿横向突出的接片336,以用于可操作地接合如上文关于缝合头组件30、130和/或230所述的外科缝合器的驱动带或驱动杆。在再一些替代实施例中,壳体能够在其内可操作地支撑一个或多个外科缝钉。在此种替代实施例中,不需要具有单独的钉仓来可操作地支撑外科缝钉。而是,壳体能够支撑缝钉,从而在接触缝钉驱动器时,缝钉被驱动出壳体外。
虽然已经描述了各实施例,但应当知道,掌握了各种实施例的一些或全部优点的本领域技术人员可能会想到这些实施例的各种修改、变型和变通形式。例如,根据各种实施例,单个部件或步骤可被多个部件或步骤代替,并且多个部件或步骤可被单个部件或步骤代替,以执行给定的一个或多个功能或实现给定目的。此外,以上所述各种部件可由多种材料制成。例如,各部件可由金属、塑料和/或生物相容性材料的任何组合制成。而且,诸如触发器、驱动带和砧座调节带的各种部件可由金属片制造和弯曲或折叠而成。因此,在不脱离所附权利要求书的范围和精神的情况下,本专利申请旨在涵盖所有这类修改、变型和变通形式。
可将本发明所公开的装置设计为单次使用后即进行处理,或者可将它们设计为可多次使用。然而无论是哪种情况,该器械都可在至少使用一次后经过修复再行使用。修复的步骤可包括装置的拆卸、清洗或更换具体部件以及后续重新组装步骤的组合。具体来讲,该装置可以拆卸,并且可以任意组合对任意数目的具体部件或零件进行选择性地更换或移除。清洗和/或更换特定部件后,可在修理厂或在紧临外科手术前由外科小组人员将器械重新装配,以供后续使用。本领域技术人员将会知道,修理装置时可以采用多种不同技术来拆卸、清洗/更换和组装。这些技术的使用以及所得的修复装置均在本发明的范围内。
本申请中的所述装置可在手术之前进行处理。首先,获取新的或用过的器械,并根据需要进行清洗。然后对装置进行消毒。在一种灭菌技术中,将器械置于封闭并密封的容器中,例如塑料或
Figure BDA00002896493900201
口袋中。然后将容器和器械置于可穿透该容器的辐射场,例如γ辐射、X射线或更高能量的电子辐射。辐射将装置上和容器中的细菌杀死。然后将灭菌后的装置保存在消毒容器中。该密封容器将器械保持无菌,直到在医疗设备中打开该容器。
据述以引用方式全部或部分地并入本申请的任何专利、公布、或其它公开材料仅在所并入的材料不与本发明所述的现有定义、陈述、或其它公开材料相冲突的程度下并入本申请。由此,在必要的程度下,本文所明确阐述的公开内容将取代以引用方式并入本文的任何相冲突材料。如果据述以引用方式并入本文但与本文所述的现有定义、陈述或其它公开材料相冲突的任何材料或其部分,仅在所并入的材料和现有的公开材料之间不产生冲突的程度下并入本文。

Claims (20)

1.一种外科缝合头组件,包括壳体,所述壳体能够在其内至少部分地可操作地支撑一个或多个外科缝钉,所述壳体还能够在其内可动地容纳芯和至少一个缝钉驱动器,所述壳体还具有至少一个保持构件,所述保持构件能够在向所述保持构件施加足够的外力时从第一位置运动至第二位置,并且其中在所述至少一个保持构件处于所述第二位置时防止所述至少一个缝钉驱动器从所述壳体驱动缝钉。
2.根据权利要求1所述的外科缝合头组件,其中所述芯还包括凹槽,所述凹槽被构造成并且其尺寸被设定成在所述至少一个保持构件处于所述第二位置时容纳所述至少一个保持构件。
3.根据权利要求1所述的外科缝合头组件,其中所述保持构件是可弹性地偏转的。
4.根据权利要求3所述的外科缝合头组件,其中所述保持构件包括悬臂。
5.根据权利要求3所述的外科缝合头组件,其中所述悬臂围绕由所述壳体限定的纵向轴线弯曲。
6.根据权利要求3所述的外科缝合头组件,其中所述悬臂沿与由所述壳体限定的纵向轴线平行的方向延伸。
7.根据权利要求3所述的外科缝合头组件,其中所述保持构件是一体的并与所述壳体形成一体。
8.根据权利要求1所述的外科缝合头组件,其中所述一个或多个外科缝钉被支撑在钉仓中,所述钉仓被支撑在所述壳体中。
9.根据权利要求1所述的外科缝合头组件,其中所述芯不包括可操作地联接到所述芯的切割构件。
10.根据权利要求1所述的外科缝合头组件,还包括可操作地联接到所述芯的切割构件。
11.一种外科缝合器,包括:
主体,所述主体包括:
柄部;和
从所述柄部延伸的轴部;
可释放地联接到所述轴部的缝合头组件,所述缝合头组件包括:
壳体,所述壳体能够在其内至少部分地可操作地支撑一个或多个外科缝钉,所述壳体还能够在其内可动地支撑芯和至少一个缝钉驱动器,所述壳体还具有至少一个保持构件,所述保持构件能够在向所述保持构件施加足够的外力时从第一位置运动至第二位置,并且其中在所述至少一个保持构件处于所述第二位置时防止所述至少一个缝钉驱动器从所述壳体驱动缝钉;
驱动系统,所述驱动系统用于向所述至少一个缝钉驱动器施加驱动运动;
砧座,所述砧座相对于所述壳体被可动地支撑以朝着和远离所述壳体轴向运动;和
砧座调节组件,所述砧座调节组件用于选择性地调节所述砧座相对于所述壳体的轴向位置。
12.根据权利要求11所述的外科缝合头组件,其中所述芯还包括凹槽,所述凹槽被构造成并且其尺寸被设定成在所述至少一个保持构件处于所述第二位置时容纳所述至少一个保持构件。
13.根据权利要求11所述的外科缝合头组件,其中所述保持构件是可弹性地偏转的。
14.根据权利要求13所述的外科缝合头组件,其中所述保持构件包括悬臂。
15.根据权利要求13所述的外科缝合头组件,其中所述悬臂围绕由所述壳体限定的纵向轴线弯曲。
16.根据权利要求13所述的外科缝合头组件,其中所述悬臂沿与由所述壳体限定的纵向轴线平行的方向延伸。
17.根据权利要求13所述的外科缝合头组件,其中所述保持构件是一体的并与所述壳体形成一体。
18.根据权利要求11所述的外科缝合头组件,其中所述一个或多个外科缝钉被支撑在钉仓中,所述钉仓被支撑在所述壳体中。
19.根据权利要求11所述的外科缝合头组件,还包括可操作地联接到所述芯的切割构件。
20.一种外科缝合头组件,包括:
壳体,所述壳体能够在其内可操作地支撑一个或多个外科缝钉,所述壳体能够在其内可动地容纳芯和至少一个缝钉驱动器;和
锁定装置,所述锁定装置用于防止所述至少一个缝钉驱动器从所述钉仓驱动缝钉。
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