CN1864642A - 具有塑料闭合板的外科钉合器 - Google Patents

具有塑料闭合板的外科钉合器 Download PDF

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CN1864642A
CN1864642A CNA2006100825550A CN200610082555A CN1864642A CN 1864642 A CN1864642 A CN 1864642A CN A2006100825550 A CNA2006100825550 A CN A2006100825550A CN 200610082555 A CN200610082555 A CN 200610082555A CN 1864642 A CN1864642 A CN 1864642A
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威廉·D·凯利
迈克尔·L·克鲁斯齐恩斯基
安东尼·T·恩格延
理查德·F·施威姆伯杰
彼得·伍库西克
戴维·L·科恩
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Ethicon Endo Surgery Inc
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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
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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
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    • 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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    • 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
    • A61B2017/07221—Stapler heads curved

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Abstract

一种用于将多个外科紧固件施加到身体组织的外科器械。所述外科器械包括一个具有近端和远端的框架，并且在近端处有一个手柄，在远端处有一个支撑结构。所述支撑结构适于支撑容纳有多个外科紧固件的筒。所述器械还包括一个闭合构件，用于支撑所述筒的至少一部分，用于将其从支撑结构的近端运动到支承结构的远端，其中闭合构件的至少一部分由塑料制成。

Description

具有塑料闭合板的外科钉合器
相关申请的交叉参考
本申请是2004年12月20日提交的序列号为11/014,910的美国专利申请的部分继续申请，该美国专利申请要求了2003年12月20日提交的序列号为60/532,912的美国临时专利申请的优先权，并将该申请在此引入作为参考。
技术领域
本发明涉及一种外科钉合和切割器械，其适于在通过钉合切除处理的病理的诊断和治疗中使用。更具体地说，本发明涉及这样一种外科钉合和切割器械，其具有特别适于人类男性骨盆的解剖的曲率。
背景技术
外科钉合和切割器械通常用在通过钉合切除处理的病理的诊断和治疗中。外科钉合器械提供了这样一种机构，其扩展了通过肛管、口腔、胃以及检查口导入的机械缝合装置的经腔利用。尽管外科钉合及切割器械最常用于直肠病理学，但是外科钉合及切割器械可在多种环境中使用。
随着时间的发展，外科钉合及切割器械得到了发展。这些器械通常包括支撑框架，与所述支撑框架连接的砧座和含有多个钉或者紧固件的筒模块。所述器械还包括在筒模块中的驱动器，所述驱动器将所有钉或紧固件同时推出到砧座中，以将钉形成为大致B形，或者将多部分聚合物紧固件连接在一起，将组织缝合在一起。此外，这些器械包括接近机构，用于将筒模块从相对于用于容纳组织的砧座隔开的位置运动到闭合位置，在此处所述组织被夹紧于砧座和筒模块之间。最后，所述器械包括发射部件，用于钉驱动器向前运动，以在砧座上形成钉。
发明内容
根据本发明，提供了一种用于将多个外科紧固件施加到身体组织上的外科器械。所述外科器械包括具有近端和远端的框架，在近端具有手柄，在远端具有支撑结构。所述支撑结构适于支撑包含多个外科紧固件的筒。所述器械还包括闭合构件，用于支撑筒的至少一部分，以使其从支撑结构的近端运动到支撑结构的远端，其中至少一部分闭合构件由塑料制成。
(1)本发明涉及一种外科器械，其用于将多个外科紧固件施加到身体组织，所述器械具有一个打开位置，以及一个用于施加所述紧固件的闭合位置，所述外科器械包括：
a.一个框架，在其近端具有一个手柄，在其远端具有一个支撑结构，所述支撑结构适于支撑所述多个外科紧固件；
b.一个闭合构件，用于支撑所述多个外科紧固件的至少一部分，用于将其从所述打开位置到所述关闭位置的运动，其中所述闭合构件的至少一部分包括塑料。
(2)如第(1)项所述的外科器械，还包括发射机构，其用于施加所述外科紧固件。
(3)如第(1)项所述的外科器械，其中，所述支撑结构基本上为C形。
(4)如第(3)项所述的外科器械，其中，所述支撑结构具有最大大约为7.8英寸直径的曲率半径。
(5)如第(3)项所述的外科器械，其中，所述支撑结构具有大约为1英寸直径到大约4英寸直径之间的曲率。
(6)如第(3)项所述的外科器械，其中，所述支撑结构具有适于配合在3.62英寸乘3.00英寸的椭圆形封套中。
(7)如第(1)项所述的外科器械，其中，所述装置适于施加至少一列外科紧固件。
(8)如第(1)项所述的外科器械，还包括用于切割组织的刀。
(9)如第(1)项所述的外科器械，其中，所述闭合构件至少部分地由选自如下组中的热塑性聚合物形成，包括：聚酰胺、聚苯硫醚、聚对苯二甲酸乙二醇酯、聚缩醛、聚酯、聚砜、聚醚砜、聚醚酰亚胺、液晶聚合物、丙烯腈丁二烯苯乙烯共聚物、聚碳酸酯、尼龙、聚氨酯、聚邻苯二甲酰胺、聚醚酮。
(10)如第(1)项所述的外科器械，其中，所述外科紧固件包括钉。
(11)本发明还涉及一种外科器械，其用于将多个外科紧固件施加到身体组织，所述外科器械包括：
a.一个框架，在其近端具有一个手柄，在其远端具有一个支撑结构，所述支撑结构适于支撑所述多个外科紧固件；
b.一个闭合构件，用于支撑所述多个外科紧固件的至少一部分，用于将其从所述打开位置到所述闭合位置的运动，其中所述闭合构件基本上完全由塑料制成。
(12)如第(11)项所述的外科器械，还包括发射机构，其用于施加所述外科紧固件。
(13)如第(11)项所述的外科器械，其中，所述支撑结构基本上为C形。
(14)如第(11)项所述的外科器械，其中，所述闭合构件至少部分地由选自如下组中的热塑性聚合物形成，包括：聚酰胺、聚苯硫醚、聚对苯二甲酸乙二醇酯、聚缩醛、聚酯、聚砜、聚醚砜、聚醚酰亚胺、液晶聚合物、丙烯腈丁二烯苯乙烯共聚物、聚碳酸酯、尼龙、聚氨酯、聚邻苯二甲酰胺、聚醚酮。
(15)如第(11)项所述的外科器械，其中，所述外科紧固件包括钉。
(16)本发明还涉及一种外科器械，其用于将多个外科紧固件施加到身体组织，所述外科器械包括：
a.一个框架，在其近端具有一个手柄，在其远端具有一个支撑结构，所述支撑结构适于支撑所述多个外科紧固件；
b.一个闭合构件，用于支撑所述多个外科紧固件的至少一部分，用于将其从所述打开位置到所述闭合位置的运动，其中所述闭合构件完全由单件模制塑料制成。
(17)如第(11)项所述的外科器械，还包括发射机构，其用于施加所述外科紧固件。
(18)如第(11)项所述的外科器械，其中，所述闭合构件至少部分地由选自如下组中的热塑性聚合物形成，包括：聚酰胺、聚苯硫醚、聚对苯二甲酸乙二醇酯、聚缩醛、聚酯、聚砜、聚醚砜、聚醚酰亚胺、液晶聚合物、丙烯腈丁二烯苯乙烯共聚物、聚碳酸酯、尼龙、聚氨酯、聚邻苯二甲酰胺、聚醚酮。
附图说明
图1是根据本发明的线性外科钉合器的透视图。
图2是线性外科钉合器的透视图，其中移除了筒模块。
图3是线性外科钉合器的透视图，其中筒外壳运动到中间位置。
图4是线性外科钉合器的透视图，其中筒外壳运动到闭合位置。
图5是线性外科钉合器的透视图，其中发射触发器处于发射位置。
图6是筒模块的分解图。
图7是筒模块的前透视图，其中保持器固定在其上。
图8是筒模块的前透视图，其中移除了保持器。
图9是筒模块的后方透视图，详细地显示出了筒外壳狭缝。
图10、11和12显示出了保持器组件。
图13是处于非致动方位的线性外科钉合器的局部剖视图。
图14是销致动机构的分解图。
图15是线性外科钉合器的局部剖视图，其中闭合触发器略微缩回。
图16是线性外科钉合器的局部剖视图，其中闭合触发器几乎完全缩回。
图17是线性外科钉合器的局部剖视图，其中闭合触发器完全缩回。
图18是线性外科钉合器的局部剖视图，其中发射触发器和闭合触发器都完全缩回。
图19是在外科医生压下释放按钮后，线性外科钉合器的局部剖视图。
图20是当释放闭合和发射触发器而不回到中间停止位置时，线性外科钉合器的局部剖视图。
图21-29显示出了筒模块的插入和定位凹槽的移除。
图30-38显示出了在本发明的线性外科钉合器的致动中涉及的多个步骤。
图39和40是筒外壳的详细主视图。
具体实施方式
这里对本发明的详细实施例进行描述。但是，应当理解，所公开的实施例仅仅作为可以多种形式体现的本发明的示例性例子。因此，这里公开的细节不应解释为限制，而仅仅是作为启示本领域技术人员如何制造和/或使用本发明的基础。
参见图1并结合图2-5，显示了外科钉合及切割器械，具体地说，显示出了一种线性外科钉合器20，其被设计成钉合和切割组织。所述线性外科钉合器20具有位于第一近端的手柄21和位于相对的远端的端部执行器80。根据本发明的优选实施例，所述端部执行器80是弯曲的。右侧和左侧结构板(通常称为“手柄板”)34、35分别将手柄21与器械的端部执行器80连接(左手柄板在图1中未显示)。手柄21具有右侧罩22，其与左侧罩联接(左侧罩在图1中未显示)。手柄21还具有主体部分23，其用于握持并操纵线性外科钉合器20(见图2-5)。
根据本发明的线性外科钉合器20特别适用于插入人类男性骨盆中。特别地说，男性骨盆包括相对较小因而在需要器械到达在齿状线附近的骨盆内的低位前切除(LAR)过程中难以接近的部分。本发明的外科钉合器20的形状和大小特别设置为在低位前切除过程中用于接近男性骨盆。特别地，线性外科钉合器20的端部执行器80适于在3.62英寸乘3.00英寸的椭圆形包络中配合并发挥作用。
因此，根据本发明的优选实施例，所述线性外科钉合器20包括具有组织端部执行器80的远端，所述端部执行器80具有直径为7.8英寸或者更小的曲率，更优选为4英寸或者更小，以便配合男性骨盆的最小包络。更具体地说，端部执行器80具有直径位于大约1英寸到大约四英寸之间的曲率，更优选位于大约两英寸到大约四英寸之间。根据更优选的实施例，端部执行器80具有直径大约为3英寸的曲率。
尽管下面公开的本发明的端部执行器80适于与具有多个元件的可置换筒模块120结合使用，但是在不背离本发明的精神的情况下，作为本发明基础的原理可用于各种端部执行器和筒模块结构。
端部执行器80是一种外科紧固组件，其包括筒模块120(参见图6-9)和C形支撑结构81。术语C形在说明书全文中用于描述支撑结构81和筒模块120的凹形性质。C形构造便于增强功能性，并且在本说明书中术语C形的使用应当解释为包括多种凹陷形状，它们同样增强了外科钉合及切割器械的功能性。闭合构件28的远端30设置为容纳筒模块120。端部执行器80还包括安全锁闭机构180(最好参见图31)，用于防止在发射筒模块120之前发射。筒模块120具有与砧座122联接的筒外壳121。筒模块120还包括定位销125、刀126、可移除的保持器160和组织接触面127，所述组织接触面127显示出具有多个容纳钉的狭槽128，其在刀126的任一侧沿着一列或多列(即，钉的列)成错开的形式。钉(未显示)从筒外壳121抵着面对筒外壳121的组织接触表面127的砧座22的钉形成表面129而发射。
如同将基于下列内容所明示的那样，本发明的线性外科钉合器20设计为具有可替换筒模块120的多发射装置。然而，应理解，在不背离本发明的精神的情况下，许多本发明的原理可同样以单个发射装置使用。
端部执行器80的支撑结构81分别通过从支撑结构81伸入手柄板34、35中的容纳孔中的台肩铆钉82和柱83与右和左手柄板34、35连接。根据本发明的一个优选实施例，支撑结构81由单件式结构形成。更具体地说，支撑结构81通过挤压件例如铝形成，随后机加工形成按照本发明公开的支撑结构81。通过以这种方式构造支撑结构81，不需要多个部件，因而大大地降低了制造和组装成本。此外，认为支撑结构81的整体式结构增加了本发明的线性外科钉合器20的整体稳定性。此外，支撑结构81的整体式挤压结构提供了减轻的重量，由于钴放射有效地穿过挤压的铝，也更容易灭菌，并且基于经挤压得到的光滑外表面，其提供了对组织更小的创伤。
线性外科钉合器20的手柄21包括把手24，其使医生能够用他的手掌握持(见图2到5)。把手24由右侧罩手柄25(见图1)和左侧罩手柄(左侧罩手柄在图1中未显示)构成。闭合触发器26和发射触发器27从手柄21的下侧可枢转地延伸。在图1中所示的线性外科钉合器20显示闭合和发射触发器26、27均位于其未致动位置，并且筒模块120插入而且移除了保持器160。因此，筒外壳121与砧座122间隔开，以将组织放置在筒外壳121和砧座122之间。
线性外科钉合器20的手柄21包括组织定位销致动机构100。组织定位销致动机构100包括定位于手柄21的顶面上的马鞍形滑块101。手动使滑块101运动导致推杆102向远侧运动。推杆102与筒模块120的定位销125联接。推杆102的向远侧运动和向近侧的回缩导致定位销125的相应的运动。定位销致动机构100还在手柄21中可释放地与闭合触发器26联接，从而闭合触发器26的致动导致定位销125如果不是已经被手动移动到其最近侧位置的话自动向远侧运动。
简要参考图2-5，显示出了当筒模块120被加载并且闭合和发射触发器26，27顺序向着把手24挤压来致动线性外科钉合器20的端部执行器80时所发生的事情。如图2所示，线性外科钉合器20加载了筒模块120，并且保持器160被移除。如在图1中所示，线性外科钉合器20现在准备容纳组织。
当闭合触发器26被部分地挤压而停靠在图3中所示的其第一止动位置时，如下面更详细讨论的，筒外壳121从其完全打开位置移动到位于打开和闭合位置之间的中间位置。同时，组织定位销致动机构100使定位销125从筒外壳121通过砧座122中的开口向前运动。在该位置，已经放置到筒外壳121和砧座122之间的组织可被正确定位，并且确保了筒外壳121和砧座122之间的组织的保持。因此，当闭合触发器26已经致动到其中间位置时，筒121和砧座122相应地定位在它们的组织保持位置。
当闭合触发器26被完全挤压从而使其邻近把手24的前端时，如图4所示，筒外壳121的组织接触表面127和砧座122的钉形成表面129彼此邻近，并且已被正确定位和保持组织因此被完全夹紧。此外，发射触发器27向着把手24逆时针旋转，以使外科医生能够握持发射触发器27，以发射钉。因此，发射触发器27现在位于外科医生对其进行挤压来钉合并切割组织的适当位置。当发射触发器27已经被完全挤压来发射钉时，如图5所示，发射触发器27停留在靠近闭合触发器26附近。
现参照图6-9，提供了对筒模块120的更详细的描述。本发明的筒模块120提供了在线性外科钉合器20中使用的切割和密封机构，其中在装置致动期间钉合及切割功能沿着相同的方向运行。尽管本发明的筒模块120特别适合与线性外科钉合装置结合使用，在不背离本发明的精神的情况下，本发明的筒模块120的设计还可用于其它外科装置。具体地说，本发明的筒模块120提供了在切割过程中与相应的垫圈123结合使用的刀126。本发明的筒模块120确保线性外科钉合器20的多次发射不会损害切割性能。这可通过使砧座122、具体地说使切割冲洗装置123包含于筒模块120来实现。通过将垫圈123和刀120与筒模块126结合，每次筒模块120被替换时，提供了新的垫圈123和刀126，导致切割性能的改进。
还通过如下方式提供增强的性能，即，将砧座122和筒外壳121平行定位，从而使它们相对于彼此运动，并且砧座122和筒外壳121的相对表面保持在平行方位。这能使得压力穿过组织均匀分布，防止了组织以如下方式被挤压，即其可能使组织成束，并迫使部分组织从砧座122和筒外壳121之间限定的所需间隔脱出。
更具体地说，筒模块120包括筒外壳121，其具有多个定位在容纳钉的狭槽128中的钉(未显示)。紧邻钉的后面设置驱动器131，其设置成推动钉脱出钉狭槽128。刀架130设置在紧靠筒外壳121中的驱动器131近侧。刀架130包括狭槽172和凸缘173，用于与刀收缩钩状件45(见图37)相互作用，所述刀收缩钩状件45的功能将在下面更详细讨论。刀架130与从刀架130经过驱动器中的狭槽200和经过筒外壳121中的狭槽199向远侧延伸的刀126连接。尽管根据本发明的优选实施例，刀描述为设置在外壳中，也可采用其它构造，而不会背离本发明的精神；例如，可以构想，筒模块能够构造为没有刀，如果专门应用如此规定。
刀架130具有止动柱138，其通过筒外壳121中的狭槽137延伸。在刀126和刀架130纵向运动期间，刀架止动柱138被设置成与筒狭槽137的止动突起139接触。类似地，驱动器131具有止动柱140，其被设置成分别与筒狭槽137的近侧和远侧止动突起141、142接触。
刀126和狭槽199、200的定位使至少一列钉位于刀的任一侧。根据本发明的优选实施例，在筒外壳121的狭槽199的每侧上提供两列钉狭槽128(以及两列钉)。
筒外壳121包括两个位于刀狭槽199的任一端的通常为圆形的开口143、144。位于筒外壳121基部的通常为圆形的开口143的形状和大小设置成使导向销124穿过筒外壳121而通过。位于筒外壳121顶部的通常为圆形的孔144的形状和大小设置成使定位销125穿过筒外壳121而通过。如此布置钉狭槽128，即，使钉经过通常为圆形的孔143、144横向地延伸。
根据本发明的优选实施例，砧座122包括塑料的垫圈123和金属的钉形成表面129。砧座122设置成将钉形成表面129保持为与钉匹配的构造。定位销125通过定位销125中的周向狭槽135以及联接器133中的沟槽134与联接器133连接(如图14中最好的显示的)。联接器133设置于筒外壳121的臂145中，并由端帽146保持在臂145内。
导向销124和定位销125分别包括狭槽147a、147b(最好参见图8、9、36、39及40)，在所述槽中设置有刀126的端部126a、126b。导向销124的近端148与砧座122的近端149连接。导向销124的远端150从筒外壳121伸出，并通过砧座122的狭槽151延伸。切割垫圈123借助砧座122上的沟糟152在砧座122上滑动，所述沟槽152在垫圈123上的舌状件153下匹配。切割垫圈123的相对端155在砧座臂155下滑动，并通过销156销接于砧座臂155中。在该位置，垫圈123的切割表面157通过砧座122的狭槽151向上延伸。切割垫圈123与砧座122的装配将导向销124捕获于由砧座狭槽151和切割表面157形成的开口中，由此操作上将砧座122与筒外壳121连接。如图7所示，保持器160与筒模块120连接，以将筒模块120的部件保持在所需的方位，直到插入端部执行器80中。
转到图6-12，并结合图25-29，将对保持器160进行更为详细的描述。保持器160具有沟槽161，其围绕筒外壳121的突起159设置。保持器160包括弹性的内弹簧臂162，其设置成在保持器160中往复运动。保持器160包括保持槽163，其部分围绕导向销124延伸。弹簧臂162包括保持槽164，其部分围绕导向销124延伸，但构造成面向与保持槽163相反的方向。保持器160定位于筒模块120上，从而使保持槽163、164围绕导向销124并将保持器160捕获于筒模块120上。弹簧臂162包括分离键片165，其从保持器160向下延伸到砧座臂155的下方。同样，保持器160不易于从筒模块120上移除，直到筒模块120正确安放在端部执行器80中。当筒模块120正确安放在端部执行器80中时，分离键片165与端部执行器80接合以释放保持器160。
再次参见图1并结合图2和图13，提供了线性外科钉合器20的元件的更为详细的描述。线性外科钉合器20包括通常具有U形横截面的细长闭合构件28，其从手柄21伸入到端部执行器80的外科紧固组件中。根据本发明的优选实施例，闭合构件28是模制的塑料构件，其形状设置用于根据本发明的运动和功能性。通过由塑料制造闭合构件28，降低了制造成本，也减轻了线性外科钉合器20的重量。此外，线性外科钉合器20更容易用钴放射灭菌，因为塑料比不锈钢易于穿透。适合的类型的塑料包括称为热塑性塑料的塑料种类，包括但不限于聚酰胺、聚苯硫醚、聚对苯二甲酸乙二醇酯、聚缩醛、聚酯、聚砜、聚醚砜、聚醚酰亚胺、液晶聚合物、丙烯腈丁二烯苯乙烯共聚物(ABS)、聚碳酸酯、尼龙、聚氨酯、聚邻苯二甲酰胺、聚醚酮，它们可以、或者可以不与例如玻璃、芳族聚酰胺纤维(aramid fiber)或碳纤维或者小珠(bead)的添加剂一起模制，以增加其强度。
可以以具有紧密公差的高度控制的形状来生产模制的元件。这将对构件28形成弯曲的形状和复杂的结构。此外，不再需要将多个板连接在一起。这种单件式模制消除了对将闭合的子系统保持在一起的例如铆钉的紧固件的需要。用于锁闭销和用于导向铆钉的其它孔由于一次在相同的工具中模制，因此可精确地对准。此外，塑料的重量远小于不锈钢，使装置的总重量减轻。就灭菌而言，塑料元件比一些不锈钢层压板更容易使钴放射穿透。最后，整体模制的闭合构件的使用允许不需要紧固件、不锈钢闭合板、塑料定位片，使组装更容易。
闭合构件28的远侧部分穿过支撑结构81的壁84。远端设置成容纳并保持筒模块120的筒外壳121。闭合构件28的中央部分分别定位在右侧和左侧手柄板34、35之间。右侧和左侧闭合连接件36、37通过第一一体的闭合连接销38分别枢转连接在闭合构件28的右侧和左侧近端。在闭合连接件36、37的相对端，闭合连接件36、37与第二一体的闭合连接销39枢转连接。第二一体的闭合连接销39将闭合连接件36、37与带狭槽的闭合臂连接件40相连。带狭槽的闭合臂连接件40在闭合触发器轴销41处枢转地安装到线性外科钉合器20的手柄板34、35上。闭合触发器26从带狭槽的闭合臂连接件40处下倾，以围绕闭合触发器轴销41向着和离开把手24枢转。当医生向着把手24挤压闭合触发器26时，容纳于手柄21的把手24中的闭合弹簧42被固定到带狭槽的闭合臂连接件40上，以提供所需的阻力，并朝开放位置偏压闭合触发器26。
参见图13和14，现在将详细描述定位销致动机构100的组成。手柄21包括马鞍形滑块101，其安装于手柄21的顶部，用于线性运动。滑块101与从推杆驱动器104经过手柄21中的狭槽105(见图2)向外延伸的柱103相连。推杆驱动器104由槽105限制，以沿着线性外科钉合器20的长轴纵向运动。推杆104通过推杆102上的周向沟槽107与推杆102相连，所述推杆102咬合于推杆104的狭槽108中。推杆102的远端具有周向沟槽109，其与筒模块120的联接器133的近端中的沟槽132相互连接(最好参见图22)。联接器133的远端具有沟槽134，用于与定位销125上的周向狭槽135相互连接。
闭合构件28包含柱29，其在手柄21内侧的闭合构件28的两侧横向地延伸。这些柱29与轭形件111的L形狭槽110可滑动地连接。所述轭形件111通过轭形件111上的轴销112枢转地安装到手柄21上。所述轭形件111包含凸轮销113，其定位成推动推杆驱动器104上的凸轮形表面114。
参见图13和图37，现在将描述发射传送组件的组成。发射传送组件具有细长的发射杆43，其从手柄21伸入端部执行器80的外科紧固组件中。发射杆43定位于闭合构件28的U形横截面中。发射杆43的远端伸入筒外壳121中，并紧邻刀架130和驱动器131的近侧定位。发射杆43的远端与具有刀收缩钩状件45的刀收缩器44连接。
发射杆43具有矩形的保持槽46，其位于发射杆43的容纳于手柄21中的那部分中(见图13)。第一一体的闭合连接销38通过保持槽46延伸。发射杆43还具有近端部分47。发射杆43的近端部分47的下侧具有滑动表面48。近端部分47还具有终端侧接合表面49，其从滑动表面48延伸。发射触发器27通过发射触发器轴销50枢转地安装到手柄板34、35上，所述发射触发器轴销50与闭合触发器轴销41间隔开，从而使每个轴销围绕相互独立的轴线枢转。发射触发器27包括拱形发射触发器连接件51，其在发射触发器轴销50处从发射触发器27伸向顶点52，所述顶点52停靠在发射杆43的近端部分47的滑动表面48上。在手柄21中，发射触发器27分别与第一及第二发射触发器弹簧臂53、54连接。发射触发器弹簧臂53、54将扭转弹簧(未显示)支撑在发射触发器27的右侧半部上。最后，发射杆回复弹簧55在发射杆43的位于手柄21中的那部分处被固定到发射杆43的下侧上，以朝发射杆的未致动位置偏压发射杆43。
当闭合触发器26被向着把手24挤压时，带槽的闭合臂连接件40和闭合连接件36和37在发射杆43的容纳槽46中向远侧运动。这种向远侧的运动导致闭合构件28相应地向远侧运动。同样地，发射杆43与闭合构件28一起同时向远侧运动，因为其上连接有闭合连接件36、37的第一一体式闭合连接销38延伸通过发射杆43中的容纳槽46。
下面将结合图13-20和图1来描述限定中间闭合止动位置以及将闭合触发器26从一个致动位置释放到其初始未致动位置的机构。带槽的闭合臂连接件40的顶侧具有一个夹紧滑动表面56，其显示具有一个中间止动件57和闭合止动件58。一个释放爪59在夹紧滑动表面56上滑动，并可与中间及闭合止动件57、58接合。释放爪59具有一个位于其远端的侧向延伸的爪凸块60(如图1最清楚可见的)。释放爪59位于手柄21中，并且其一体地连接于设置在手柄21外部上的释放按钮61。释放按钮61具有一个拇指支座62，并且释放按钮61与手柄21通过一个释放耳轴63可枢转地连接。释放按钮61从手柄21向外偏置，因此，释放爪59通过释放弹簧64向着夹紧滑动表面56向下偏置，所述释放弹簧64通过弹簧定位销65安装于手柄21上，并通过按钮弹簧柱66安装于释放按钮61上。带槽的闭合臂连接件40具有一个位于中间和闭合止动件57、58之间的拱形凹槽67。位于拱形凹槽67中用于旋转运动的是左侧拉钳68，其与右侧拉钳(右侧拉钳未显示)一体地连接。每个拉钳68具有一个拉钳臂69，其可与爪凸块60接合。爪凸块60具有凹陷的近侧表面70，以在拉钳臂69和爪凸块60之间提供间隙。
下面将参考图31(筒和支撑结构的剖视图)描述发射装置闭锁机构180的构成。
如同基于下列描述所能理解的那样，一旦已击发该装置，闭锁机构180会阻止筒外壳121向其第二闭合位置的运动，但允许筒外壳121和砧座122的相对再接近运动，从而再接近运动提供了器械没有出故障的指示。当处于第一间隔位置时，允许再接近为筒外壳121和砧座122之间的总距离的大约1/4到大约2/3，更优选地，当处于第一间隔位置时，其为筒外壳和砧座之间的总距离的1/4、1/3或者1/2。
闭锁机构180包括闭锁杆181，其通过销182可枢转地安装于闭合构件28的远端30上。闭锁杆181由一个弹簧(未显示)向下弹性偏压向支撑结构81的基部。闭锁杆181分别包括近端和远端184、185。近端184具有一个凸轮形表面186和闭锁槽187。端部执行器80的支撑结构81包括凸缘85，其设置为当闭锁机构180接合时与闭锁槽187相互作用。支撑结构81包括一个位于各壁84之间的基面86。基面86设置为当闭锁杆181未接合时与凸轮形表面186相互作用。
筒模块120、闭合机构、止动销机构、发射传送组件、中间和闭合止动件57、58、释放机构和闭锁机构180的装载操作将在下面详细描述。参见图7到12以及图21到28，描述了将筒模块120装载到端部执行器80中。筒模块120的形状和大小设置为能从线性外科钉合器20的组织端部执行器80中选择性地插入和移除。
在将筒模块120插入到线性外科钉合器20的端部执行器80中之前，如图7中所示，由于沟槽161设置在保持器160的顶端围绕突起159以阻止其分离，不容易将保持器160从筒模块120中移除。而且，如图25所示，保持器的保持槽163、164设置在保持器160的底部围绕导销124以阻止其分离。连接的保持器160提供了对筒模块120结构的支撑，并提供了用于夹持的延伸表面区域，这两个特征均使装载更容易。在随机处理期间，保持器160还防止钉从筒外壳121中脱离，并在随机处理期间防止刀126意外地暴露。
在装载之前和装载过程中，刀126的运动和钉的运动通过一系列止动件被进一步阻止。参见图9，通过筒外壳槽137上的止动突起139防止刀架130上的止动柱138向近侧和远侧运动。通过止动柱140与套筒外壳槽137上的止动突起141相互作用，可防止驱动器131由于随机处理以及在将筒模块120装载到线性外科钉合器20中期间向远侧的运动。
筒模块120被装载到组织执行器80中，使筒外壳121滑进闭合构件28的远端30中，如图21到24所示。在装载过程中，闭合构件28上的壁31a和31b滑进筒外壳121的槽170a、170b中。同时，键片174(见图8)滑进C形支撑结构81的沟槽88中。当止动件171卡合到闭合构件远端30的止动槽32上时，筒模块120的装载完成，如图21到24所示。
在图24中显示的位置，筒模块120完全装载，并且联接器133的近侧槽132与推杆102的远侧周向槽109接合，从而使筒模块120中的止动销125与止动销行进机构100连接。在装载过程中，刀架131的槽172与刀回缩钩状件45接合，从而在筒模块120装载完成时使钩状件45与刀架130上的回缩凸缘173接合。
在筒模块120装载完成时，一个定位于驱动器131上的柱188与闭锁杆181的远端185接触(见图31)。这种接触使闭锁杆181围绕闭锁杆销182枢转到某一位置，从而使凸轮形表面186与U形支撑结构81的基面86水平对准。
保持器160现在可从端部执行器80中移除。特别地，筒模块120装载的完成引起分离键片165与支撑结构81接触(见图23)，导致当筒模块120完全装载时弹簧臂162向上运动，如图24所示。这种向上运动使保持槽164向上移位，使导销124不再被包含(见图25与26)。现在参见图27到29，施加到拇指垫166上的去除力导致保持器160围绕突起159向外枢转，直到沟槽161能够使突起159滑脱。保持器160的除去使得装载的线性外科钉合器20可被利用。
在图15中，闭合触发器26已经从如图1与13所示的打开的未致动位置被部分挤压。当闭合触发器26被部分挤压时，其围绕闭合触发器轴销41沿着逆时针方向向着把手24枢转。随着其枢转，带槽的闭合臂连接件40和闭合板闭合连接件36、37向前运动，因而使闭合构件28和发射杆43向远侧运动。随着带槽的闭合臂连接件40向前运动，释放爪59的爪凸块60在夹紧滑动表面56上滑动。爪凸块60与拉钳68的拉钳臂69的远端接合，并由此使拉钳68沿着顺时针方向枢转。随着带槽臂闭合连接件40响应于闭合触发器26向着把手24的枢转运动而继续向前运动，释放爪59的爪凸块60将最终移动到中间止动件57中。一旦定位于中间止动件57中，闭合弹簧42就不能将闭合触发器26回复到其初始未致动位置。闭合触发器26现在位于其中间的部分闭合位置，以在筒外壳121和砧座122之间正确定位并保持组织，如图15所示。此外，随着闭合构件28和发射杆43向远侧运动，拱形发射触发器连接件51的顶点52在发射杆43的近端部分47的滑动表面48上滑动。
在从打开到中间位置的闭合冲程过程中，止动销机构100致动。闭合构件28的向前运动使一体柱29向远侧运动。柱29与轭形件111的L形槽110接触。因此，柱29的向远侧运动使L形槽110进行仿形运动，引起轭形件围绕销112枢转。旋转造成轭形件111上的支承柱113与推杆驱动器104上的凸轮形表面114接触。轭形件111的进一步旋转运动引起支承柱113通过在表面114上的仿形接触使推杆驱动器104向远侧运动。推杆驱动器104与推杆102接触，从而向远侧运动推杆102。推杆102又使联接器133和止动销125向远侧运动。到达中间止动件57位置的闭合冲程的完成导致止动销125通过筒外壳121的孔144向远侧运动，通过垫圈123和砧座122的孔159，并进入支撑结构81中的孔(未显示)中。置于筒外壳121的接触表面127和砧座122之间的组织现在被陷获于止动销125和导销124之间。
这种相同的结果可在闭合之前通过手工向远侧运动马鞍状滑块101获得。滑动运动将导致推杆102、联接器133和止动销125向前运动，直到止动销125完全通过砧座122、垫圈123和在支撑结构81中的孔89放置。在止动销125已经手工向前运动后闭合冲程的致动将仍可导致轭形件111的旋转，如上所述，但止动销致动机构100没有任何附加的运动。
当闭锁杆181通过销182与闭合构件28连接时，从打开到中间止动件57的位置的闭合冲程使闭锁杆181向远侧运动，如图31(打开)和图32(中间位置)所示。闭锁杆181的向远侧运动引起凸轮形表面186与支撑结构81的闭锁凸缘85接触，导致闭锁杆181顺时针旋转并与支撑结构81的基面86滑动接触。在该位置，闭锁杆181的远端185已经旋转脱离驱动器131上的柱188。
现在特别参见图16，当闭合触发器26被从中间止动件57位置向着把手24挤压时，拉钳68的拉钳臂69与爪凸块60脱离接合。相应地，随着拉钳68继续沿着顺时针方向旋转，释放爪凸块60架在拉钳臂69上，并且其随着闭合触发器26的运动落入止动件58中。在释放爪59架在拉钳臂69上时，其使释放按钮61围绕枢轴63顺时针旋转。在释放爪60落入闭合止动件58中时，能听见的卡嗒音警告外科医生已经达到闭合位置。
另外，随着发射杆43继续向前运动，拱形发射触发器连接件51的顶点52与发射杆43的近端部分47的侧接合表面49接触。相应地，在组织已经完全被夹紧后，发射触发器27运动到其可连续向远侧运动发射杆43来发射钉的位置中。当拱形发射触发器连接件51的顶点52运动到与近端部分47的接合表面49接合时，响应于发射触发器27的右手侧上的扭转弹簧的动作(扭转弹簧未显示)，发射触发器27开始沿着逆时针方向向着把手24枢轴旋转。发射触发器27独立于闭合触发器26的枢转运动而枢转，但其枢轴旋转被阻碍，直到发射杆43已经向远侧运动到能够使发射触发器连接件51与发射杆43的终端接合表面接合。
特别转到图17，当闭合触发器26已经完全被挤压并邻近把手24时，在释放爪59远端处的爪凸块60容纳于闭合止动件58中。在该止动件58的位置，组织已经完全被夹紧在筒外壳121和砧座122之间，并且闭合弹42不能使闭合触发器26回复到其初始位置。因此，闭合触发器26被限制在图4中显示的位置。
与闭合触发器26的逆时针运动同时，发射触发器27通过扭转发射杆回复弹55的动作连续逆时针旋转，直到发射触发器27相对于线性外科钉合器20的手柄21处于相对垂直方向。在完全夹紧位置，拱形发射触发器连接件51的顶点52已经完全与发射杆43的近端部分47的接合表面接合，因此，发射触发器27位于进一步将发射杆43向远侧运动的位置，以将钉发射到组织中。
在完全闭合位置，筒外壳121的钉袋128与砧座122的钉形成表面129对准，如图33所示。止动销125与砧座122的顶部对准，并且筒外壳121和导销124将筒外壳121的底部与砧座122的底部对准。
如图18和图34所示，发射触发器27可被挤压而使其向着把手24枢轴旋转，直到其定位在闭合触发器26附近。在发射触发器27枢轴旋转过程中，发射杆43向远侧运动，与刀架130接触。刀架130的向远侧的运动导致刀126与驱动器131的接触。驱动器131向远侧的运动导致钉(未显示)向远侧行进到砧座122的钉形成表面129中，从而导致形成大致为B形的钉。与钉形成同时的，刀126在导销124和止动销125的槽147中向远侧行进。这些槽147将刀126引导到切割垫圈123的切割表面157上，从而导致任何捕获于其间的组织的横切。
对发射触发器27手动施压的释放导致发射杆回复弹55将发射杆43回缩，并将发射触发器27回复到图17中显示的位置。这种运动导致回缩钩状件45将刀架130上的回缩凸缘173和刀126回缩。产生的近侧运动将刀126回缩到筒外壳121中，如图35所示。刀架130上的止动柱138回缩成与筒外壳121上的止动件139接合，以将刀架130和刀126保持在该回缩位置。驱动器131通过与驱动器131上的止动柱140与筒槽137的接合止动件142的接合被限制在其最远侧(发射)位置。
如果对于刀126存在冲突(用户错误切入另一外科器械)，使得来自发射杆回复弹簧55的力不足以回缩发射杆43，因而不足以将刀126回缩到筒外壳121中，用户可通过在发射触发器27上顺时针推动来手工回缩切割系统。手动顺时针运动引起拱形发射触发器连接件51顺时针旋转，直到其撞击发射杆43的近端47上的发射杆回缩键片71。顺时针运动的拱形发射触发器连接件51和发射杆回缩键片71的接触导致发射杆43向近侧回缩，并返回到图17中显示的位置。这又引起回缩钩状件45将刀架130上的回缩凸缘173和刀126缩回。因此，这种安全零件使用户能够将切割机构回缩到安全位置，并将发射系统返回到使线性外科钉合器20能够被打开的位置，如下所述。
参见图19，当医生压下释放按钮61时，释放爪59围绕释放耳轴63以顺时针方向枢转，以将爪凸块60从闭合止动件58的位置移出来。随着其被移出，爪凸块60架在拉钳臂69上，以绕过在夹紧连接件40上的中间止动件位置57。这样，响应于从闭合弹簧42和发射杆回复弹簧55所产生的偏压，闭合和发射触发器26、27可返回到它们最初的未致动位置。当爪凸块60架在拉钳68的拉钳臂上时，在闭合和发射触发器26、27沿顺时针方向旋转以返回到它们的最初未致动位置时，拉钳臂69逆时针旋转。因此，医生可释放闭合和发射触发器26、27，使它们返回到图20所示的位置，而不需要返回到中间止动件57的位置。
线性外科钉合器20释放到图20中所示的打开位置导致闭合构件28和连接的闭锁杆181回缩到如图36所示的完全打开位置。在该位置，驱动器131上的柱188不再设置为向下保持闭锁杆远端185。如上所述，驱动器131已经通过柱140和筒止动件142定位于向前的位置处。因此，当闭锁杆181(其近端184沿着支撑臂表面86滑动)完全回缩时，它现在能自由地逆时针旋转并落入位于C形支撑结构81上的凸缘185下方的闭锁槽187中。当筒模块120如图37所示被移除时，闭锁杆181将保留在该位置。
闭合已经被发射的线性外科钉合器20的任何未来的企图都会导致将闭锁槽187钩在凸缘85中，如图38所示，从而为先前发射装置的用户提供反馈。如果保持器160在装载之前已经被移除，并且筒模块120已经被错误装载，而筒模块120没有处在正确的位置，闭锁槽187和凸缘85将接合。在这种情况下，如上所述，驱动器柱188将不会处于将闭锁杆181运动到在表面86上向上突出的位置中的正确位置。同样地，已经击发的筒模块120也将不会释放闭锁机构180。重要的是，注意在钩入凸缘85中的闭锁槽187接合之前，在闭锁机构180中允许存在闭合冲程。该冲程向用户表明，装置没有因为一些故障而被阻塞，如像闭锁机构180没有冲程可能反应的那样。因此，当闭锁机构接合时，用户知道装置没有被阻塞，但没有被正确装载。
在图1和2中显示的将装置释放返回到打开位置后，止动销机构100必须通过在马鞍101上向近侧拉动来手工回缩。这种回缩引起止动销125回缩到筒外壳121中。在手工回缩完成后，发射的筒模块120可卸载并用新的筒模块120替换。
上述装置不仅适用于弧形钉合器，本发明还可等同适用于非弧形钉合器，例如Witt等的在1997年2月25日授权的美国专利US5,605,272；Brinkerhoff等的美国专利US5,275,322，以及美国专利US5,706,998，它们都通过引用而包含于本申请中。
尽管在此已经示出并说明了本发明的优选实施例，但是对本领域普通技术人员来说显而易见的是，这些实施例仅仅作为例子提供。现在，本领域普通技术人员可做出各种变化、改变和替代而不背离本发明。例如，如同对本领域普通技术人员来说显而易见的那样，这里的描述在机器人辅助外科学中具有相同的应用。此外，应当理解，上面描述的每种结构具有一种功能，并且所述结构可被认为是一种执行所述功能的部件。因此，旨在本发明仅仅由所附的权利要求书的精神和范围来限定。

Claims (10)

1.一种外科器械，其用于将多个外科紧固件施加到身体组织，所述器械具有一个打开位置，以及一个用于施加所述紧固件的闭合位置，所述外科器械包括：
a.一个框架，在其近端具有一个手柄，在其远端具有一个支撑结构，所述支撑结构适于支撑所述多个外科紧固件；
b.一个闭合构件，用于支撑所述多个外科紧固件的至少一部分，用于将其从所述打开位置到所述关闭位置的运动，其中所述闭合构件的至少一部分包括塑料。
2.如权利要求1所述的外科器械，还包括发射机构，其用于施加所述外科紧固件。
3.如权利要求1所述的外科器械，其中，所述支撑结构基本上为C形。
4.如权利要求3所述的外科器械，其中，所述支撑结构具有最大大约为7.8英寸直径的曲率半径。
5.如权利要求3所述的外科器械，其中，所述支撑结构具有大约为1英寸直径到大约4英寸直径之间的曲率。
6.如权利要求3所述的外科器械，其中，所述支撑结构具有适于配合在3.62英寸乘3.00英寸的椭圆形封套中。
7.如权利要求1所述的外科器械，其中，所述装置适于施加至少一列外科紧固件。
8.如权利要求1所述的外科器械，还包括用于切割组织的刀。
9.如权利要求1所述的外科器械，其中，所述闭合构件至少部分地由选自如下组中的热塑性聚合物形成，包括：聚酰胺、聚苯硫醚、聚对苯二甲酸乙二醇酯、聚缩醛、聚酯、聚砜、聚醚砜、聚醚酰亚胺、液晶聚合物、丙烯腈丁二烯苯乙烯共聚物、聚碳酸酯、尼龙、聚氨酯、聚邻苯二甲酰胺、聚醚酮。
10.如权利要求1所述的外科器械，其中，所述外科紧固件包括钉。
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