CN101541251A - 带紧固组织用可压缩/碎构件的外科钉和施放钉的缝合器 - Google Patents

带紧固组织用可压缩/碎构件的外科钉和施放钉的缝合器 Download PDF

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CN101541251A
CN101541251A CNA2007800419530A CN200780041953A CN101541251A CN 101541251 A CN101541251 A CN 101541251A CN A2007800419530 A CNA2007800419530 A CN A2007800419530A CN 200780041953 A CN200780041953 A CN 200780041953A CN 101541251 A CN101541251 A CN 101541251A
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nail
tissue
anvil block
hat
assembly
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CN101541251B (zh
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C·J·赫斯
J·R·摩根
W·B·威森伯格二世
J·W·沃格尔
M·S·奥尔蒂斯
M·J·斯托克斯
C·舒特莱夫
F·E·谢尔顿四世
J·S·斯韦兹
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Ethicon Endo Surgery Inc
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Abstract

本发明涉及具有用于紧固其中的组织的可压缩或可压碎构件的外科钉和用于施放所述外科钉的缝合器械。该钉具有钉冠(1302)、从钉冠延伸的可变形的腿部(1344)，以及从钉冠延伸的弹簧(1352)，该弹簧被构造成将组织压缩在弹簧和可变形的构件之间。由于弹簧具有挠性，钉可以适应较大范围的组织厚度同时仍然压缩被捕获在其中的组织。因此，单一的钉设计可以用于多种外科手术，由此减少必须向外科医生提供的钉的设计数量。在至少一种实施方式，钉包括可压碎构件。该可压碎构件可包括可塑性变形的第一部分和可弹性变形的第二部分。

Description

带紧固组织用可压缩/碎构件的外科钉和施放钉的缝合器
相关申请的交叉引用
本申请涉及与其同一日期提交的十一件共同未决、共同拥有的申请，这些申请的每一件的全部公开内容在此通过引用结合入本文，这十一件申请分别为：
(1)Frederick E.Shelton，IV，Jerome R.Morgan，Michael A.Murray，Richard W.Timm，James T.Spivey，James W.Voegele，LeslieM.Fugikawa和Eugene L.Timperman：Surgical Stapling InstrumentsHaving Flexible Channel and Anvil Features For Adjustable StapleHeights(K&LNG律师卷号No.060500CIP1/END5706USCIP1)；
(2)Frederick E.Shelton，IV，Jeffrey S.Swayze，Leslie M.Fugikawa和Eugene L.Timperman：Surgical Stapling Instruments WithCollapsible Features For Controlling Staple Height(K&LNG律师卷号No.060500CIP2/END5706USCIP2)；
(3)Frederick E.Shelton，IV和Joshua Uth：Surgical Cutting andStapling Instrument With Self Adjusting Anvil(K&LNG律师卷号No.060492/END5962USNP)；
(4)Frederick E.Shelton，IV和Jeffrey.S.Swayze：SurgicalCutting and Stapling Device With Closure Apparatus For LimitingMaximum Tissue Compression Force(K&LNG律师卷号No.060493/END5963USNP)；
(5)Todd Phillip Omaits，Bennie Thompson，Frederick E.Shelton，IV和Eugene L.Timperman：Surgical Stapling Instrument WithMechanical Mechanism For Limiting Maximum Tissue Compression(K&LNG律师卷号No.060490/END5960USNP)；
(6)Christopher J.Hess，William B.Weisenburgh，II，Jerome R.Morgan，James W.Voegele，Frederick E.Shelton，IV和Joshua Uth：Surgical Stapling Instruments and Staples(K&LNG律师卷号No.060494/END5965USNP)；
(7)Christopher J.Hess，Michael A.Murray，Jerome R.Morgan，James W.Voegele，Robert Gill和Michael Clem：Surgical StaplesHaving Dissolvable，Bioabsorbable or Biofragmentable Portions andStapling Instruments For Deploying The Same(K&LNG律师卷号No.060495/END5966USNP)；
(8)Christopher J.Hess，William B.Weisenburgh，II，Jerome R.Morgan，Frederick E.Shelton，IV，Leslie M.Fugikawa和Eugene L.Timperman：Connected Surgical Staples and Stapling Instruments ForDeploying the Same(K&LNG律师卷号No.060499/END5970USNP)；
(9)Christopher J.Hess，Jerome R.Morgan，Michael Clem，Frederick E.Shelton，IV和William B.Weisenburgh，II：SurgicalStaples Having Attached Drivers and Stapling Instruments ForDeploying the Same(K&LNG律师卷号No.060496/END5967USNP)；
(10)Christopher J.Hess，William B.Weisenburgh，II，Jerome R.Morgan，Frederick E.Shelton，IV和Darrel Powell：Surgical Staplesand Stapling Instruments(K&LNG律师卷号No.060498/END5969USNP)；以及
(11)Todd P.Omaits，Bennie Thompson，Frederick E.Shelton，IV和Eugene L.Timperman：Surgical Stapling Instrument With MechanicalIndicator To Show Levels of Tissue Compression(K&LNG律师卷号No.060491/END5961USNP)。
技术领域
本申请总的涉及内窥镜和开放式外科器械，更具体地，涉及外科钉和缝合器，包括但不限于开放式外科缝合装置、腹腔镜外科缝合装置、内窥镜和腔内外科缝合装置。
背景技术
由于较小的切口缩短了术后康复时间并减少了并发症，内窥镜和腹腔镜外科器械常常比传统的开放式外科装置更受青睐。内窥镜和腹腔镜外科手术的使用已经相当普遍，并且已经提供了另外的激励以进一步发展这些手术。在腹腔镜手术中，通过小的切口在腹部内进行外科手术。类似地，在内窥镜手术中，通过经皮肤中的小的进入创口插入的狭窄内窥镜管在身体的任何中空脏腑中进行外科手术。
腹腔镜和内窥镜手术一般需要对外科手术区域吹注气体。因此，插入到身体中的任何器械必须被密封以确保气体不会经过切口进入或者排出身体。此外，腹腔镜和内窥镜手术常常需要外科医生在距离切口很远的器官、组织和/或血管上动作。因此，在所述手术中使用的器械通常是长而窄的，同时可从器械的近端进行功能控制。
适于将远端执行器通过套管针的套管精确地设置到需要的外科手术部位的内窥镜外科器械领域已经得到了显著发展。这些远端执行器以多种方式接合组织以达到诊断或者治疗效果(例如，内切割器、抓取器、切割器、缝合器、夹具施放器、进入装置、药物/基因治疗输送装置，以及采用超声波、RF、激光的能量装置等)。
已知的外科缝合器包括同时在组织中形成纵向切口并将钉线施加到切口的相对侧上的端部执行器。端部执行器包括一对协作的钳口构件，如果器械用于内窥镜或者腹腔镜应用，这对钳口构件能够穿过套管通道。一个钳口构件容纳具有至少两排横向间隔开的钉的钉仓。另一个钳口构件限定砧座，该砧座具有与钉仓中的钉排对准的钉成形凹窝。该器械包括多个往复运动的楔形件，当被向远侧驱动时，这些楔形件穿过钉仓中的开口并接合支撑钉的驱动器，来向着砧座对钉实施击发。
近来，一种改进的“E形梁”击发杆被描述用于外科缝合和切割器械，所述器械有利地包括在上钳口(砧座)中形成的内槽中滑动的顶部销，并具有中部销和在端部执行器的下钳口(或者更具体的钉施放组件)的相对侧上滑动的底部脚部。位于中部销远侧的接触表面致动保持在形成下钳口的细长钉通道中的钉仓。在接触表面与顶部销之间，切割表面或者刀切割夹钳在砧座和下钳口的钉仓之间的组织。由于两个钳口由此由E形梁接合，E形梁保持了钳口之间的所需间隔，从而确保正确的钉成形。因此，如果夹钳了更少量的组织，E形梁提起砧座以确保用于钉的足够间隔，从而抵靠着砧座的下表面使钉正确成形。另外，如果夹钳了更大量的组织，E形梁向下拉动砧座以确保间隔不会超过钉的长度导致每个钉的端部不能充分弯曲，以实现所需的保持程度。这种E形梁击发杆在2003年5月20日提交的申请号为10/443,617、题为“Surgical StaplingInstrument Incorporating an E-Beam Firing Mechanism”、已于2005年12月27日公告的美国专利US6978921中被描述，该文献的全部内容通过引用结合入本文。
虽然E形梁击发杆具有用于外科缝合和切割器械的许多优点，但常常需要切割并缝合各种厚度的组织。薄的组织层可能导致仅仅松动地成形的钉，可能需要衬垫材料。厚的组织层可能导致成形的钉将很强的压缩力施加到被捕获的组织上，这或许导致坏死、出血或者不良的钉成形/保持。可能需要使相同的外科缝合和切割器械适用于更宽范围的组织厚度，而不是限制适于给定外科缝合和切割器械的组织厚度范围。
相应地，非常需要一种改进的外科缝合和切割器械，其结合有能根据夹钳的组织量调节的钉施放组件(端部执行器)。
另外，在现有钉施放组件中一般采用的钉驱动器传统上被制成尽可能硬以确保正确的“B”形钉高度。由于这种硬的构造，这些驱动器不提供用于根据被夹钳在组件中的特定组织厚度调节钉成形高度的任何灵活性。
因此，还非常需要一种钉驱动器，其能够便于响应于组织厚度的变化对钉成形高度进行调节。
在各种类型的内切割器设置中，砧座通过轴向致动闭合管组件被打开和闭合，所述闭合管组件用于与砧座近端上的闭合特征件连接。砧座通常形成有容纳在通道近端中的略微细长的槽中的耳轴。耳轴用于枢转地支撑钉仓并允许砧座在枢转到闭合位置时运动成轴向对准。但遗憾的是，这种设置缺少用于限制或调节在夹钳过程中施加到砧座的夹钳力的大小的部件。因此，由闭合管组件产生的相同大小的夹钳力被施加到砧座，而不考虑待夹钳于其中的组织的厚度。所述设置可能导致较薄的组织被过度夹钳，这可能导致过多出血和可能损伤或甚至破环组织。
因此，还需要一种闭合系统，该闭合系统包括基于待夹钳于砧座与钉仓之间的组织厚度来限制或调节施加到砧座上的闭合力的大小的部件。
在一些类型的外科手术中，外科钉的使用已经变成了连接组织的优选方法，并且特别配置的外科缝合器已经被发展用于这些应用。例如，腔内或者圆形缝合器已经被发展用于被称为吻合术的外科手术。对于进行吻合术有用的圆形缝合器例如在美国专利US5104025和美国专利US5309927中被公开，这些文献的内容通过引用而结合入本文。
吻合术为一种外科手术，其中，在连接部分已经被切除后肠的部分被连接在一起。手术需要将两个管状部分的端部连接在一起形成连续的管状通道。以前，这种外科手术属于费力而耗时的手术。医生必须精确地切割并使肠的端部对准且在将端部用多个缝线针脚连接起来的同时保持对准。圆形缝合器的发展已经极大地简化了吻合手术，并且还缩短了进行吻合所需要的时间。
一般说来，常规圆形缝合器典型地包括细长轴，所述细长轴具有安装在轴上的近侧致动机构和远侧缝合机构。远侧缝合机构典型地包括含有多个被设置成同心圆阵列的钉的固定钉仓。圆形切割刀同心地安装在仓中并位于钉内侧。刀可沿轴向向远侧方向运动。从仓的中心轴向延伸的是套管针轴。套管针轴可相对于仓和细长轴沿轴向运动。砧座构件被安装在套管针轴上。砧座构件具有安装到其上、用于使钉端部成形的常规钉砧座。钉仓的远侧面与钉砧座之间的距离由安装在缝合器轴的近端上的调节机构来控制。当致动机构由医生致动时，包含在钉仓与钉砧座之间的组织同时被缝合和切割。
当使用圆形缝合器进行吻合时，典型地，使用具有被安放在肠的目标部分(即样本)任一侧上的双排钉的常规外科缝合器来缝合肠。当目标部分被缝合时，该部分典型地同时被切割。接着，在除去样本后，医生典型地将砧座插入到腔的近端、钉线的近侧。这通过将砧座头部插入由医生在近侧腔中切割的进口中。有时，砧座可经肛门放置，通过将砧座头部设置在缝合器的远端上并将器械经直肠插入而经肛门放置。典型地，缝合器的远端经肛门插入。医生然后使用缝线或者其他常规结扎装置将肠的近端系到砧座轴上。接着，医生切割位于被系住位置附近的多余组织，并且医生将砧座与缝合器的套管针轴连接。医生然后封闭砧座与仓之间的间隔，从而将间隔中的肠的近端与远端接合。医生接着致动缝合器，引起数个钉排被驱动穿过肠的两端并成形，从而连接端部并形成管状通道。同时，当钉被驱动并成形时，同心圆形刀被驱动穿过肠组织端部，切割与内排钉相邻的端部。医生然后从肠中退出缝合器，吻合完成。
但是，在缝合过程中，医生必须小心地不能过度压缩被缝合的材料以避免杀死或者不利地损坏该组织。虽然一些现有缝合器配备有指示机构，该指示机构为医生提供砧座与钉仓之间的间隔的一些指示，但需要缝合器包括能提供用于避免过度压缩组织的部件的机构。
发明内容
在各种实施方式中，本发明包括钉，该钉具有钉冠、从钉冠延伸的可变形的腿部，以及从钉冠延伸的弹簧，该弹簧被构造成将组织压缩在弹簧和可变形的构件之间。在这些实施方式中，由于弹簧具有挠性，钉可以适应较大范围的组织厚度同时仍然充分压缩被捕获在其中的组织。因此，例如单一的钉设计可以用于多种外科手术，由此减少必须向外科医生提供的钉的设计数量。
在各种实施方式中，本发明包括能够插入到组织中的外科紧固件，其中，该紧固件包括钉冠、从该钉冠延伸的可变形的构件，以及从该钉冠延伸的弹簧，该弹簧被构造成偏压组织以使组织抵靠可变形的构件。在至少一种实施方式中，外科紧固件包括可压碎构件。该可压碎构件可以包括可塑性变形的第一部分和可弹性变形的第二部分。在各种实施方式中，本发明还可以包括钉冠、从该钉冠延伸的可变形的第一构件，以及用于压缩组织使其抵靠可变形的第一构件的部件。
附图说明
包含于本说明书中并构成其一部分的附图示出了本发明的实施方式，并与上面给出的本发明的总体说明和下面给出的实施方式的详细描述一起用于解释本发明的原理。
图1是具有打开的端部执行器(钉施放组件)的外科缝合和切割器械的左侧正视图，其中轴被部分切除以暴露击发构件，该击发构件由通过机架底导引并由闭合套筒包围的近侧击发杆和远侧击发杆构成。
图2是沿着图1中线2-2的纵向竖直剖面截取的图1所示外科缝合和切割器械的闭合的端部执行器(钉施放组件)的左侧视图，其具有与本发明一致的回缩力调节高度的击发杆。
图3是图2的力调节(顺应)高度击发杆的左侧等轴测图。
图4是图2的力调节高度击发杆的第一方案的远侧部分(“E形梁”)的左侧视图，其具有分别在顶部销与切割表面之间以及在中部销与切割表面之间形成的水平缝以增强竖直挠曲。
图5是图2的力调节击发杆的第二种方案的远侧部分(“E形梁”)的从左下侧观看的等轴测图，其具有上部销的带减弱下部区域(relieved lower area)以增强竖直挠曲。
图6是在沿着线6-6穿过上部销的竖直横向剖面中截取的图5所示E形梁的上部部分的主视图。
图7是在沿着线6-6的竖直横向剖面中截取的图5所示E形梁的第三种方案的上部部分的主视图，但进一步包括顶部销的带减弱的上部根部连接部以增强竖直挠曲。
图8是在沿着线6-6的竖直横向剖面中截取的图5所示E形梁的第四种方案的上部部分的主视图，但包括竖直的弹性内叠层，代替顶部销的减弱的下表面以增强竖直挠曲。
图9是在沿着线6-6的竖直横向剖面中截取的图5所示E形梁的第五种方案的上部部分的主视图，但包括由弹性材料形成的上部销，代替上部销的减弱的下表面以增强竖直挠曲。
图10是图2的力调节击发杆的第六种方案的远侧部分(“E形梁”)的从左上侧观察的等轴测图，其在底部根部上具有弹性材料以增强竖直挠曲。
图11是在经过图1的外科缝合和切割器械的端部执行器(钉施放组件)的加垫下部根部的竖直横向剖面中截取的主视图。
图12是图2的力调节击发杆的第七种方案的远侧部分(“E形梁”)的左侧视图，其具有与下部根部连接的向近侧和向上延伸的弹簧臂以增强竖直挠曲。
图13是图2的力调节击发杆的第八种方案的远侧部分(“E形梁”)的从左侧俯视的等轴测图，其具有包围下部根部的弹簧垫圈以增强竖直挠曲。
图14是处于夹钳或闭合位置中的本发明的另一种钉施放组件或者端部执行器的端剖视图。
图15是图14的钉施放组件的局部透视图，其部分元件以剖面显示。
图16是处于夹钳或闭合位置中的本发明的另一种钉施放组件或者端部执行器的端剖视图。
图17是图16的钉施放组件的局部透视图，其部分元件以剖面显示。
图18是本发明的钉施放组件的局部透视图，其夹钳了一片组织，该组织已经被部分切割并缝合。
图19是本发明的砧座实施方式的仰视图。
图20是采用图19中示出的砧座实施方式的钉施放组件的纵剖视图。
图21是沿着图20中的线21-21截取的图20所示的钉施放组件的端剖视图，其中为清楚起见一些元件以实体形式显示。
图22是其中夹钳了一片组织的图20和21的钉施放组件的另一纵向剖视图，其中组织具有变化的剖面厚度。
图23是其中夹钳了另一片组织的图20-22的钉施放组件的另一局部纵向剖视图。
图24是其中夹钳了另一片组织的图20-23的钉施放组件的另一局部纵向剖视图。
图25是处于夹钳位置中的本发明的另一钉施放组件的端剖视图。
图26是本发明的另一钉施放组件的纵向剖视图。
图27是本发明的另一钉施放组件的一部分的剖视图，其中在钉施放组件中一片组织被夹钳并缝合。
图28是本发明的偏压板实施方式的一部分的俯视图。
图29是沿着图28中的线29-29截取的图28所示偏压板的一部分的剖视图。
图30是图27的钉施放组件的端剖视图，其中为清楚起见一些元件以实体形式显示。
图30A是本发明的另一种钉施放组件的端剖视图，其中为清楚起见一些元件以实体形式显示。
图31是图27和30的钉施放组件的纵向剖视图，其中在钉施放组件中组织被夹钳并缝合。
图32是图31的钉施放组件的另一纵向剖视图，其中在钉施放组件中另一部分组织被夹钳并缝合。
图33是图30-32的钉施放组件的另一纵向剖视图，其与由本发明的各种实施方式的手柄组件支撑的流体容器流体连接。
图34是本发明的其他实施方式的钉施放组件的纵向剖视图，其中变化厚度的组织被夹钳在钉施放组件中。
图35是图34的钉施放组件的一部分的放大剖视图。
图36是处于第一(未收缩)位置中的本发明的可收缩钉驱动器实施方式的分解透视图。
图37是图36的可收缩钉驱动器实施方式的剖视图。
图38是处于第一(未收缩)位置中的本发明的另一种可收缩钉驱动器实施方式的分解透视图。
图39是图38的可收缩钉驱动器实施方式的剖视图。
图40是本发明的另一种可收缩钉驱动器实施方式的透视图。
图41是图40的可收缩钉驱动器实施方式的分解透视图。
图42是处于第一(未收缩)位置中的图40和41的可收缩钉驱动器实施方式的剖视图。
图43是图40-42的可收缩钉驱动器实施方式的另一剖视图，其中压缩力已经被施加到可收缩钉驱动器上。
图44是本发明的另一种可收缩钉驱动器实施方式的分解透视图。
图45是处于第一(未收缩)位置中的图44的可收缩钉驱动器实施方式的剖视图。
图46是图44和45的可收缩钉驱动器实施方式的分解透视图，其一些元件以剖面显示。
图47是本发明的另一种可收缩钉驱动器实施方式的分解主视图。
图48是处于第一(未收缩)位置中的图47的可收缩钉驱动器的另一主视图。
图49是在已经被压缩到完全收缩位置之后的图47和48的钉驱动器的另一主视图。
图50是本发明的另一种可收缩钉驱动器实施方式的分解组装图。
图51是图50的可收缩钉驱动器实施方式的分解主视图。
图52是被压缩到完全收缩位置后的图50和51的可收缩钉驱动器实施方式的另一主视图。
图53是本发明的另一种可收缩钉驱动器实施方式的透视图。
图54是处于第一(未收缩)位置中的图53的可收缩钉驱动器的侧视图。
图55是被压缩到完全收缩位置后的图53和54的可收缩钉驱动器实施方式的另一侧视图。
图56是本发明的各种实施方式的外科切割和缝合器械的透视图。
图57是本发明的各种实施方式的端部执行器和细长轴组件的分解组装图。
图58是本发明的各种实施方式的手柄组件和闭合梭(shuttle)设置的分解组装图，其中为了清楚起见省去了击发系统的元件。
图59是图58中示出的手柄组件的侧剖视图，该手柄组件的闭合扳机处于锁定位置。
图60是本发明的各种实施方式的闭合梭和闭合管组件的从左侧观察的分解组装图。
图61是本发明的各种实施方式的闭合梭和闭合管组件的从右侧观察的分解组装图。
图62是闭合管组件的与部分闭合的砧座相互作用的远端的局部放大图，其中为了清楚起见一些元件以剖面显示。
图63是图62的闭合管和砧座的另一局部放大图，其中砧座被示出处于完全闭合位置并且为清楚起见一些元件以剖面显示。
图64是本发明的各种实施方式的闭合管组件和砧座的局部透视图。
图65是本发明的各种实施方式的另一闭合管组件和砧座的局部透视图。
图66是本发明的各种实施方式的另一闭合管组件和砧座的局部透视图，其中砧座处于完全闭合位置。
图67是图66的闭合管和砧座设置的端剖视图，其中为清楚起见省去了细长通道。
图68是本发明的其他各种实施方式的闭合管和砧座设置的局部放大图，其中砧座处于部分闭合位置。
图69是图68的闭合管和砧座设置的另一局部放大图，其中砧座处于完全闭合位置。
图70是本发明的另一内切割器实施方式的剖视图，其砧座处于打开位置并且为清楚起见一些元件以实体形式显示。
图71是图70的内切割器实施方式的另一剖视图，其砧座处于完全闭合位置并且为清楚起见一些元件以实体形式显示。
图72是图70和71中示出的实施方式的砧座和闭合管组件的一部分的放大剖视图，其中砧座处于完全闭合位置。
图73是图70的内切割器实施方式的另一剖视图，其中砧座处于最大夹钳位置并且为清楚起见一些元件以实体显示。
图74是图73中示出的实施方式的一部分砧座和闭合管组件的放大剖视图，其中砧座处于其最大夹钳位置。
图75是夹钳了一片薄组织的图70-74中示出的内切割器的一部分的放大剖视图。
图76是夹钳了一片较厚组织的图70-75中示出的内切割器的一部分的另一放大剖视图。
图77是本发明的各种实施方式的另一缝合器械的透视图。
图78是可被图77中示出类型的各种缝合器实施方式采用的砧座和头部设置的分解组装透视图。
图79是可被图77中示出类型的各种缝合器实施方式采用的轴和扳机组件的分解透视图。
图80是本发明的轴组件和头部组件实施方式的局部剖视图，其中砧座与轴组件连接。
图81是本发明的各种实施方式的手柄组件和闭合调节器组件的剖视图。
图82是轴组件、扳机组件、钉驱动器、砧座和闭合调节器组件的透视图，其中手柄外壳、头部外壳和外部管状护罩从其上被除去。
图83是本发明的调节器组件实施方式的剖视图。
图84是沿着图83中的线84-84截取的图83所示调节器组件的剖视图。
图85是被插入到分开的肠部分中的本发明的缝合器实施方式的局部剖视图。
图86是图85的钉和肠布置的另一剖视图，其中肠的近端和远端被缝合在砧座轴周围。
图87是砧座被回缩到完全压缩位置并且在击发缝合器之前的图85和86的缝合器和肠布置的另一剖视图。
图88是钉已经被击发并且刀已经切割已缝合的肠的部分之后图85-87的缝合器和肠布置的另一剖视图。
图89是本发明的另一缝合器实施方式的透视图。
图90是图89的缝合器的一部分的局部剖视图。
图91是可被图89和90的缝合器采用的闭合致动器的剖视图。
图92是沿着图91中的线92-92截取的图91所示闭合致动器的剖视图。
图93是缝合器砧座被回缩到完全压缩位置并且在击发缝合器之前被插入到肠部分中的图89-92所示缝合器的一部分的剖视图。
图94是示出压缩力与由可与本发明的各种实施方式结合使用的变力发生器产生的阻抗负载(resistive load)之间的关系的图表。
图95是图91和92的闭合致动器的另一视图。
图96是根据本发明的实施方式的处于未施放形状的外科钉的侧视图。
图97是处于第一变形形状的图96的钉的侧视图。
图98是处于第二变形形状的图96的钉的侧视图。
图99是处于第三变形形状的图96的钉的侧视图。
图100是图99的钉的俯视图。
图101是图96的钉的透视图。
图102是图97的钉的透视图。
图103是图98的钉的透视图。
图104是图99的钉的透视图。
图105是根据本发明的实施方式的外科缝合器且以各种变形形状示出的外科钉的局部剖视图。
图106是根据本发明的替代实施方式的外科钉的侧视图。
图107是图106的钉的透视图。
图108是根据本发明的替代实施方式的钉的侧视图。
图109是图108的钉的俯视图。
图110是处于变形形状的图108的钉的侧视图。
图111是根据本发明的替代实施方式的钉的侧视图。
图112是根据本发明的替代实施方式的钉的侧视图。
图113是包括可压碎构件的根据本发明的实施方式的外科钉的侧视图。
图114是处于变形形状的图113的钉的侧视图。
图115是根据本发明的实施方式的外科钉的侧视图，该外科钉包括具有第一弹性构件和第二弹性构件的弹簧。
图116是图115的钉的俯视图。
图117是包括悬臂弹簧的根据本发明的实施方式的外科钉的侧视图。
图118是图117的钉的俯视图。
图119是包括弹簧的根据本发明的实施方式的外科钉的侧视图。
图120是处于变形形状的图119的钉的侧视图。
图121是图120的钉的俯视图。
图122是根据本发明的实施方式的钉的第一和第二可变形构件的透视图。
图123是包覆模制在图122的可变形构件上的可溶解或者可生物吸收材料的透视图。
图124是处于变形形状的图123的钉的透视图。
图125是图124的钉的透视图，其中一部分可溶解材料已经被溶解并且第一和第二可变形构件已经相对于彼此运动。
图126是可溶解材料完全被溶解之后的图125的钉的透视图。
图127是根据本发明的实施方式的外科缝合器的局部剖视图，该外科缝合器具有砧座和用于可移除地储存钉的钉仓。
图128是图127的缝合器的局部剖视图，示出一些钉处于各种变形形状。
图129是沿着图127的线129-129截取的图127的缝合器的局部剖视图。
图129A是图129的钉的详细视图。
图130是处于第一变形形状的图129A的钉的详细视图。
图131是处于第二变形形状的图129A的钉的详细视图。
图132是根据本发明的替代实施方式的钉的侧视图，其具有被包覆模制在可变形构件上的两种材料。
图133是根据本发明的替代实施方式的钉的详细视图。
图134是根据本发明的替代实施方式的钉的详细视图。
图135是根据本发明的实施方式的钉的透视图。
图136是被构造成容纳图135的钉的钉仓的俯视图。
图137是图136的钉仓的详细视图。
图138是图136的钉仓的第二详细视图。
图139是其中带有图135所示钉的图136的钉仓的剖视图。
图140是根据本发明的实施方式的缝合器的钉和钉仓的透视图。
图141是图140的钉仓的详细视图。
图142是图140的钉带的透视图。
图143是图142的钉的详细视图。
图144是图140的钉和钉仓的侧剖视图。
图145是根据本发明的替代实施方式的钉带的透视图。
图146是图145的钉的详细视图。
图147是正在施放图145所示的钉的缝合器的侧剖视图。
图148是根据本发明的替代实施方式的钉带的透视图。
图149是图148的钉的详细视图。
图150是正在施放图149的钉的缝合器的侧剖视图。
图151是根据本发明的替代实施方式的钉带的透视图。
图152是储存在钉仓中的图151的钉带的视图。
图153是沿着图152中的线153-153截取的图152的钉仓的剖视图。
图154是沿着图153中的线154-154截取的图152的钉仓的剖视图。
图155是图152的钉仓的剖视透视图，其中钉被定位在第一位置。
图156是图152的钉仓的剖视透视图，其中钉被定位在第二位置。
图157是图152的钉仓的其他剖视透视图。
图158是以“盘(puck)”的构型连接的根据本发明的实施方式的钉的透视图。
图159是被构造成容纳图158的钉的根据本发明的替代实施方式的钉仓的仰视图。
图159A是图159的钉仓的详细视图。
图160是放置在图159的钉仓的驱动器上方的图158的钉的透视图。
图161是图160的驱动器的透视图。
图162是图159的钉仓的剖视图。
图163是图159的钉仓的第二剖视图。
图164是根据本发明的替代实施方式的钉仓的仰视图。
图164A是图164的钉仓的详细视图。
图165是根据本发明的替代实施方式的钉的透视图。
图166是图165的钉的第二透视图。
图167是根据本发明的实施方式正由缝合器施放的图165的钉的剖视图。
图168是根据本发明的实施方式的钉组件的透视图。
图169是图168的钉组件的俯视图。
图170是被构造成容纳图169的钉组件的钉仓的透视图。
图171是图170的钉仓的俯视图。
图172是图168的钉和图170的钉仓的剖视图。
图173是根据本发明的替代实施方式的钉组件的透视图。
图174是用于形成非平行的钉模式的根据本发明的替代实施方式的钉组件的透视图。
图175是放置在根据本发明的实施方式的钉仓内的图174的钉的俯视图。
图176是根据本发明的钉和钉仓的俯视图。
图177是图176的钉仓的详细视图。
图178是示出图176的钉仓的可剪切仓板(deck)的剖视图。
具体实施方式
参照附图，其中相同的附图标记在全部附图中表示相同的组成元件，在图1中，外科缝合和切割器械10包括手柄部分12，该手柄部分12可被操作以放置执行部分14，该执行部分14包括在远侧连接到细长轴18的紧固端部执行器，图示为钉施放组件16。执行部分14的尺寸设置成，在钉施放组件16的上钳口(砧座)20和下钳口22通过向着手柄部分12的手枪式把手26压下闭合扳机24(这推进细长轴18的外侧闭合套筒28以枢转关闭砧座20)而被闭合的条件下，该尺寸能够通过套管针的套管(未显示)插入，用于内窥镜或腹腔镜外科手术。
一旦插入到吹注气体的体腔或者腔内，医生可通过扭转轴旋转调节器30使执行部分14围绕其纵向轴线旋转，所述轴旋转调节器30接合在手柄部分12的远端和细长轴18的近端上。由此被设置，闭合扳机24可被释放，打开砧座20，于是组织可被夹持并定位。一旦对保持在钉施放组件16中的组织感到满意，则医生按压闭合扳机24直到该闭合扳机24抵靠手枪式把手26被锁定，从而将组织夹钳在钉施放组件16的内部。
然后，击发扳机32被按压，向着闭合扳机24和手枪式把手26被拉动，由此施加击发力或者运动给该击发扳机，从而从未击发位置向远侧推进击发构件。所示击发构件包括与远侧击发杆36连接的近侧击发杆34，所述远侧击发杆被支撑在将手柄部分12与钉施放组件16连接的机架底38中。在钉击发运动过程中，击发杆36接合细长钉通道40并致动包含在其中的钉仓42，钉通道和钉仓二者形成下钳口22。击发杆36还接合闭合的砧座20。在释放击发扳机32以将回缩力或运动施加到击发杆36之后，对闭合释放按钮44的按压会松开闭合扳机24，于是闭合套筒28可被回缩以枢转并打开砧座20，以便从钉施放组件16中释放被切割和缝合的组织。
应当理解，空间术语例如竖直、水平、右、左等在这里参照附图给出，假定外科器械10的纵向轴线与细长轴18的中心轴线共轴，并且扳机24、32以锐角从手柄组件12的底部向下延伸。然而，在实际实践中，外科器械10可以各种角度使用，就此而言，这些空间术语相对于外科器械10本身被使用。此外，使用的术语“近侧”是用于表示就位于手柄组件12之后并将执行部分14向远侧或者远离他或她自身放置的医生的视角。但是，外科器械可以任何朝向和位置被使用，这些术语并不是想要对其进行限制和绝对化。
在图2中，钉施放组件16被闭合在被压缩的组织46上。在图2-3中，击发杆36具有与在钉施放组件16内平移的远侧E形梁50连接的近侧部分48。如图所示，在击发杆36回缩的情况下，E形梁50的竖直部分52基本上位于钉仓42的尾部，如同新的钉仓42已经被插入到细长钉通道40中之后那样。从E形梁50的竖直部分52的上部横向延伸出的上部销54最初位于砧座凹窝56中，该砧座凹窝56在砧座20的枢转近侧端部附近凹陷。在钉击发运动过程中当E形梁50向远侧行进时，竖直部分52穿过在砧座20的钉成形下表面60中形成的狭窄纵向砧座槽58(图1、11)、在仓42中形成的向近侧敞开的竖直槽62和在细长钉通道40中形成的下面的纵向通道槽64。
在图2、11中，狭窄纵向砧座槽58(图2)向上与尺寸设置成可滑动容纳上部销54的横向加宽的纵向砧座通道66连通。纵向通道槽64向下与容纳下部脚部70的横向加宽的纵向通道轨68连通，所述下部脚部的尺寸设置成在纵向通道轨68中滑动并与E形梁50的竖直部分52的底部连接。从E形梁50的竖直部分52延伸出的横向加宽的中部销72被设置成沿着钉仓42的底部盘74的顶面滑动，底部盘74又支撑在细长钉通道40上。在底部盘74上方的钉仓42中形成的纵向击发凹槽75的尺寸设置成允许中部销72平移通过钉仓42。
E形梁50的竖直部分52的远侧驱动表面76被设置成平移通过钉仓42的向近侧敞开的竖直槽62并向远侧驱动楔形滑动件78，该楔形滑动件78在近侧设置在钉仓42中。E形梁50的竖直部分52包括沿着位于远侧驱动表面76上方和上部销54下方的远侧边缘的切割表面80，该切割表面80在缝合进行的同时切割被夹钳的组织46。
特别参照图11，应当理解，楔形滑动件78向上驱动钉驱动器82，钉驱动器82又向上驱动钉83离开在钉仓42的钉主体85中形成的钉孔84，以便抵靠砧座20的下表面60成形钉，该下表面60与钉仓42的上表面43成面向关系(图2)。
在图2、图11中，有利地，在上部销54之间由箭头86表示的图示的间隔(图2)朝着压缩状态顺应地被偏压，其中0.015英寸的压缩组织46被包含在钉施放组件16中。但是，由于E形梁50的固有挠曲，大至大约0.025英寸的更大量的被压缩组织46也是允许的。如果钉的长度不足以形成附加高度，则可能达到0.030英寸的过度挠曲应当被避免。应当理解，这些尺寸仅仅是对于0.036英寸的钉高度而示意性给出的。但对于每个种类的钉来说同样也是如此。
在图4中，柔顺性的E形梁50a的第一种方案包括从竖直部分52a的远侧边缘开始的顶部和底部水平狭缝90、92，可由电钻机器(EDM)形成这些狭缝。竖直部分52a由此包括：具有上部销54的在竖直方向上柔顺的向远侧突出的顶部臂94，具有切割表面80的刀凸缘96，以及具有远侧驱动表面76、中部销72和下部脚部70的下部竖直部分98。水平狭缝90、92通过允许朝向远侧的顶部臂94向上枢转而允许顺应的竖直间隔，从而适应来自被压缩组织46(未显示)的增大的力。
在图5-6中，柔顺性E形梁50b的第二种方案包括形成于竖直部分52的每侧的上部销54b中的左和右下部减弱区域110、112，并分别留有左和右下部支撑点114、116。支撑点114、116的外侧位置提供了用于施加力的长的力矩臂以便挠曲。应当理解，本发明具有如下优点，即，减弱区域110、112的尺寸和用于柔顺性E形梁50b的材料的选择可考虑钉尺寸和其他情况被选择用于所需挠曲程度。
在图7中，柔顺性E形梁50c的第三种方案如上参照图5-6的描述一样，但通过在上部销54c的靠近竖直部分52的相对顶部根部表面中形成的左、右上部狭窄减弱区域120、122提供进一步的挠曲。
在图8中，柔顺性E形梁50d的第四种方案如在图2-3中的描述一样，但增加了复合/层压竖直部分52d的特征，该复合/层压竖直部分52d包括夹设于左、右竖直层132、134之间的中央弹性竖直层130，左、右竖直层132、134分别支撑上部销54d的左、右部分136、138。当左、右部分136、138向上或向下挠曲时，由此产生的左、右竖直层132、134的弯曲由中央弹性竖直层130的相应压缩或膨胀来提供。
在图9中，柔顺性E形梁50e的第五种方案如在图2-3中的描述，但增加了由通过穿过竖直部分52e的水平孔140插入的更柔性材料形成分立的上部销54e的特征。因此，分立的上部销54e的左、右外端142、144根据负载力发生挠曲。
作为对将挠曲结合到上部销54中的替代或者附加，在图10-11中，如图2-3中描述的那样的柔顺性E形梁50f的第六种方案进一步包括弹性垫150，弹性垫150与底部脚部70的上表面152连接。弹性垫150根据在底部脚部70处所承受的压缩力调节上部销54的间隔。
在图12中，柔顺性E形梁50g的第七种方案如在图2-3中的描述一样，但增加了如下特征：底部脚部(靴形件)70g具有向后上延伸的弹簧指160，所述弹簧指向下弹性促动E形梁50g以根据负载力调节竖直间隔。
在图13中，柔顺性E形梁50h的第八种方案如在图2-3中描述的那样，但增加了如下特征：卵圆形弹性垫圈170置于围绕竖直部分52的底部脚部70上面并具有向上弯曲的中央部分172，所述向上挠曲的中央部分172向下弹性促动E形梁50h以根据负载调节竖直间隔。
作为另一个例子，与本发明的各方面一致的柔顺性E形梁可包括与砧座的接合，该接合类似于在抵靠细长钉通道的相对侧滑动的两个结构的图示方案中的接合。类似地，柔顺性E形梁可通过具有横向加宽部分来接合下钳口，所述横向加宽部分在下钳口结构中形成的通道内部滑动。
作为再一个例子，在图示的方案中，钉仓42可被更换，从而使钉施放组件16的其它部分可被再次使用。应当理解，本发明具有如下优点：与本发明一致的应用可包括更大的一次性部分，诸如细长轴的远侧部分以及带有永久接合作为下钳口的一部分的钉仓的上、下钳口。
作为还一种例子，有利的是，图示的E形梁确定地将上、下钳口彼此间隔开。因此，E形梁具有向内接合的表面，该向内接合的表面在更大量的被压缩组织趋向于展开钳口的情况下的击发过程中将钳口拉到一起。由此E形梁防止钉由于超过它们的有效长度而畸形。另外，E形梁具有向外接合的表面，该向外接合的表面在少量组织或者器械的其他结构特征趋向于将钳口夹紧在一起而导致钉畸形的情况下在击发的过程中推动钳口分开。两种功能之一或者两者都可通过与本发明的各方面一致的应用来增强，其中E形梁中的固有挠曲与用于允许钳口的闭合程度或者钳口的打开程度的力相适应。
图14是外科器械10a的端剖视图，所述器械具有本发明的另一种实施方式的钉施放组件16a，其中相同的附图标记被用于表示相同的元件，并且该器械采用细长通道40a将钉仓42支撑在其中。在各种实施方式中，通道40a具有被构造成使钉施放组件16a能够有效地适应不同的组织厚度的弹性或柔性特征部。图15是钉施放组件16a的局部透视图，为清楚起见中一些元件以剖面被显示。从图14中可以看出，在该实施方式中，第一纵向延伸的减弱区域180和第二纵向延伸的减弱区域184设置在纵向通道40a中。第一纵向延伸的减弱区域180限定了第一弹性或柔性通道凸缘部分182，第二纵向延伸的减弱区域184限定了第二弹性或柔性通道凸缘部分186。E形梁50形式的击发构件的竖直部分52的上端51穿过细长通道槽64延伸，该细长通道槽64在柔性凸缘部分182、186各自的自由端183、185之间形成。从图14中可进一步看出，所述设置允许E形梁50的下部脚部70支承于柔性凸缘部分182、186上，以便当E形梁50穿过其中时适应被夹钳在砧座20与下钳口22之间的组织的厚度差。应当理解，凸缘部分182、186的厚度可被选择成为细长通道40a的那些部分提供所需挠曲程度。而且，考虑到钉尺寸和其他考虑，用于细长通道40a的材料的选择可被选择为用于所需挠曲程度。
上面描述的细长通道40a可与采用常规砧座20的钉施放组件结合使用。也就是说，纵向延伸的砧座槽58基本上可具有“T”形形状，其尺寸设置成容纳E形梁50的竖直部分52的上端51和上部销54。图14和15中示出的实施方式采用砧座20a，砧座20a具有弹性或者柔性特征部以便进一步适应被夹钳在砧座20a与下钳口22之间的组织厚度差。特别是，如从图14中可以看到的那样，第三纵向延伸的减弱区域190和第四纵向延伸的减弱区域194可设置在砧座20a中，如图所示。第三纵向延伸的减弱区域190限定了第一砧座凸缘部分192，第四纵向延伸的减弱区域194限定了第二砧座凸缘部分196，E形梁50的上部销54可支承于第一砧座凸缘部分192和第二砧座凸缘部分196上。这种设置给砧座20a提供了挠曲程度以适应被夹钳在砧座20a与下钳口22之间的组织厚度差。应当理解，凸缘部分182、196的厚度198可被选择成为砧座20a的那些部分提供所需的挠曲程度。而且，考虑到钉尺寸和其他考虑，用于砧座20a的材料选择可被选择成用于所需挠曲程度。砧座20a可与上面描述的如图14和15所示的通道设置结合使用，或者在不背离本发明的精神和范围的条件下，砧座20a可与常规通道设置结合使用。
本领域普通技术人员还将会理解，砧座20a和/或通道40a可成功地与常规E形梁设置或者在这里示出的任何E形梁设置一起使用。这里公开的E形梁可通过容纳在手柄组件中的控制设置被往复驱动。所述控制设置的例子在2005年12月27日公告的美国专利US6978921中公开，该文献的内容已经通过引用结合入本文。在不背离本发明的精神和范围的条件下，可采用其他已知的用于将击发和回缩力或者运动施加于E形梁上的击发构件布置和控制设置。
图16和17示出了采用通道40b和砧座20b的另一种方案的钉施放组件16b，所述通道和砧座每个都具有弹性或者柔性部分以适应被夹钳在砧座20b与下钳口22b之间的组织的厚度差。从那些附图中可以看到，第一对200上、下纵向延伸的减弱或底切区域202、204设置在通道40b中以限定第一悬臂型支撑凸缘206，第二对210减弱或底切区域212、214设置在通道40b中以限定第二悬臂型支撑凸缘216。第一对减弱区域202、204为第一支撑凸缘206提供了挠曲程度，使其能够如图箭头205所示那样挠曲。类似地，第二对减弱区域212、214为第二支撑凸缘216提供了挠曲程度，使其能够如图箭头215所示那样挠曲。如与上述实施方式一样，支撑凸缘206和216的厚度218可被选择成为细长通道40b的那些部分提供所需的挠曲程度，以适应不同的组织厚度。而且，考虑到钉尺寸和其他考虑，用于细长通道40b的材料选择可被选择为用于所需的挠曲程度。
图16和17进一步示出了具有T形槽58b的砧座20b，该T形槽58b限定第一侧壁部分220和第二侧壁部分222。在各种实施方式中，第一纵向延伸的底切区域224设置在第一侧壁部分220中以限定弹性或者柔性第一凸缘226。类似地，在各种实施方式中，第二纵向延伸的底切区域228设置在第二侧壁部分222中以限定弹性或者柔性第二凸缘230。从图16中可以看出，第一和第二凸缘226、230的端部227、231分别用于限定砧座槽58b被E形梁50b的上端部分51延伸穿过的部分59b。所述设置允许E形梁50b的上部销54b可支承在第一弹性凸缘226和第二弹性凸缘230上，以给砧座20b提供挠曲程度，从而适应被夹钳在砧座20b与下钳口22b之间的组织的厚度差。应当理解，凸缘226、230的厚度232可被选择成为砧座20b提供所需的挠曲程度来适应不同的组织厚度。而且，考虑到钉尺寸和其他考虑，用于砧座20b的材料的选择可被选择为用于所需挠曲程度。砧座20b可与上面描述的在图16和17中显示的通道40b结合使用，或者其可与常规通道设置一起使用。本领域技术人员还将会理解，砧座20a和/或通道40b可成功地与常规E形梁设置或者这里描述的任一E形梁一起使用。
图18示出了使用本发明的各种外科切割和缝合器械实施方式的任一种来切割和缝合组织240。图18中示出的组织240的一部分242已经被切割并缝合。在医生已经切割并缝合第一部分242之后，器械可被退出，使新的钉仓42可被安装。图18示出了在开始第二次切割和缝合过程之前执行部分14的位置。从该图可以看出，已经被缝合的组织240的部分242具有比组织240的其他部分244的厚度245小的厚度243。
图19是可与本发明的各种实施方式的钉施放组件16c一起使用的砧座20c的下侧的视图。砧座20c包括砧座主体21c，该砧座主体21c支撑限定不同钉区的可运动的钉成形凹窝。在图19所示的实施方式中，在砧座主体21c内，四个左侧钉区252、254、256、258设置在砧座槽58c的左侧250上，四个右侧钉区262、264、266、268设置在砧座槽58c的右侧260上。左侧第一钉区252由左侧第一钉成形插入件270限定，插入件270中具有一系列钉成形凹窝272。在该实施方式中，三排274、276、278钉成形凹窝272设置在插入件270中。从图19中可以看出，凹窝272的中央排276相对于凹窝272的两个外侧排274、278略微纵向偏移，并与相应钉仓42中的相应钉孔84的设置对应。本领域普通技术人员将会理解，所述设置用于以交错的方式施放钉83，如图18所示。
类似地，左侧第二钉区254可由其中可具有三排282、284、286钉成形凹窝272的左侧第二钉成形插入件280限定。左侧第三钉区256可由其中可具有三排292、294、296钉成形凹窝272的左侧第三钉成形插入件290限定。左侧第四钉区258可由其中可具有三排302、304、306钉成形凹窝272的左侧第四钉成形插入件300限定。左侧第一、第二、第三和第四钉成形插入件270、280、290、300在设置在砧座20c中位于砧座槽58的左侧250的左侧腔251中沿纵向排成一直线。
右侧第一钉区262可由其中具有一系列钉成形凹窝272的右侧第一钉成形插入件310限定。在该实施方式中，三排312、314、316钉成形凹窝272设置在插入件310中。从图19中可以看出，钉成形凹窝272的中央排314相对于两个外侧排312、316略微纵向偏移并与相应钉仓42中的相应钉孔84的设置对应。所述设置用于以交错的方式在组织切割线的右侧施放钉83。右侧第二钉区264可由其中可具有三排322、324、326钉成形凹窝272的右侧第二钉成形插入件320限定。右侧第三钉区266可由其中可具有三排332、334、336钉成形凹窝272的右侧第三钉成形插入件330限定。右侧第四钉区268可由其中可具有三排342、344、346钉成形凹窝272的右侧第四钉成形插入件340限定。右侧第一、第二、第三和第四钉成形插入件310、320、330、340在设置在砧座20c中位于砧座槽58的右侧260的右侧腔221中沿纵向排成一直线。在各种实施方式中，钉成形插入件可由不锈钢或者比制成钉的材料更硬的其他合适材料制成。例如，插入件可成功地由其他材料诸如钴铬合金、铝，17-4不锈钢、300系列不锈钢、400系列不锈钢、其他沉淀硬化不锈钢等制成。
与每个钉成形插入件270、280、290、300、310、320、330、340对应的至少一个偏压构件或者柔顺构件设置在各个左侧钉成形插入件270、280、290、300与左侧腔251的底部之间，如图20-23所示，所述至少一个偏压构件或者柔顺构件的形式为波形弹簧350或者其他合适的偏压或柔顺介质或构件。波形弹簧350或者其他合适的偏压或柔顺介质或构件也设置在每个右侧钉成形插入件310、320、330、340与右侧腔261的底面之间。位于砧座槽58c的左侧的波形弹簧350可被容纳在相应的弹簧腔253中，并且位于砧座槽58c的右侧的波形弹簧350可被容纳在相应的弹簧腔263中。为了将每个插入件270、280、290、300、310、320、330、340偏压地保持在砧座20c中，每个插入件270、280、290、300、310、320、330、340可通过例如粘合剂或者其他紧固件设置与其相应弹簧350或者偏压构件连接。另外，每个弹簧350可通过例如粘合剂或者其他机械紧固件设置与砧座20c连接，以便将波形弹簧350的一部分保持在其相应的弹簧腔253或263中。这样的弹簧/偏压构件设置用于向着组织240和钉偏压插入件270、280、290、300、310、320、330、340，并本质上作为弹性“振动吸收器”以适应组织厚度差。该优点在图22-24中被示出。
特别是，如在图22中可以看出，组织240的被夹钳在钉施放组件16c的近端17b中的部分242具有比组织240的被夹钳在钉施放组件16c的中央部分17c中的部分244的厚度(箭头245)更厚的第一厚度(箭头243)。组织部分244的厚度245大于组织240的被夹钳在钉施放组件16c的远端17a中的部分246的厚度(箭头247)。因此，由于组织厚度差，在钉施放组件16c的远端17a中成形的钉83比在钉施放组件16c的中央部分17c中成形的钉83更紧密地成形，而在钉施放组件16c的中央部分17c中成形的钉比在钉施放组件16c的近端17b中成形的那些钉83更紧密地成形。图23进一步示出了基于被夹钳在钉施放组件16c中的组织厚度变化的钉成形高度的变化。图24示出了被夹钳在钉施放组件16c的中央部分17c的组织240比被夹钳在钉施放组件16c的远端和近端的组织部分更厚的情形。因此，中央部分17c中的钉成形高度将比与钉施放组件16c的近端17b和远端17a有关的钉的钉成形高度更高。
本领域普通技术人员将会理解，图19-24中示出的实施方式的独特新颖的特征也可与上面描述的钉施放组件16c在构造和操作上基本相同的钉施放组件相结合使用，但钉成形插入件270、280、290、300、310、320、330、340中可具有仅仅一排钉成形凹窝272或者其中具有两排钉成形凹窝272。例如，图25示出了仅仅将两排钉施放在组织切割线的每一侧的实施方式。在该图中显示的是每个仅仅具有两排钉成形凹窝272d的钉成形插入件270d和310d。
本领域技术人员将会进一步理解，在砧座槽58的每侧采用的钉成形插入件的数目可变化。例如，可在砧座槽58的每一侧使用单个纵向延伸的插入件。图26示出了本发明的另一种钉施放组件16e，其在砧座槽的每一侧仅仅采用一个钉成形插入件。图26示出了砧座20e的左侧的剖视图，其中砧座支撑与单个波形弹簧350e连接的单个左侧钉成形插入件380。其他偏压构件或者多个波形弹簧或者偏压构件也可被使用。一个或多个偏压构件350e被支撑在左侧腔251e中并以上面描述的各种方式的一种与砧座20e连接。类似的右侧插入件(未显示)可在砧座槽58的右侧被使用。此外，尽管图19-24示出了在砧座槽的每侧使用四个钉成形插入件，但更多数目的钉成形插入件可被采用。
图27-29示出了本发明的另一种钉施放组件16f，其中独立的可运动钉成形插入件被提供用于每个钉83。特别是，从图27中可以看出，单个钉成形插入件400被提供用于每个钉83。每个钉成形插入件400可具有在其下侧402上形成的钉成形凹窝404以便使相应钉83的端部成形。如与上面描述的各种实施方式一样，每个插入件400具有与其相关联的偏压构件412。在图27-29所示的例子中，偏压构件412构成偏压板410的冲压部分。偏压板410可包括一片金属或者其他合适的材料，其中每个偏压构件412被冲压或者切割并与钉成形插入件400对应形成。偏压板410可包括被支撑在砧座20f中的腔251f中的单个板，或者多个板410可在砧座槽的每侧上被使用。应当理解，类似设置可在砧座槽的右侧上被采用。每个钉成形插入件400可通过粘合剂或者其他合适的紧固件设置与其相应的偏压构件412连接。因此，应当理解，在不偏离本发明的精神和范围的条件下，可采用各种不同数目和设置的可运动钉成形插入件。特别是，至少一个可运动钉成形插入件可在砧座槽的每侧上被使用。
图30-32示出了本发明的其他实施方式的另一种钉施放组件16g，其中钉成形插入件与砧座之间的偏压或者柔顺介质包括至少一个流体囊。更具体地说，如图30中可以看到的那样，左侧囊420被放置在砧座20g中的砧座槽58g的左侧上的左侧腔253g内。同样地，右侧囊430被放置在砧座20g中的右侧腔263g内。一系列左侧钉成形插入件270g、280g、290g、300g可通过合适的粘合剂或者其他紧固件设置与左侧囊430连接。同样地，右侧钉成形插入件(未显示)可通过粘合剂或者其他合适的紧固件设置与右侧囊430连接。在一种实施方式中，每个囊420、430被密封并且部分填充有液体432，例如诸如甘油或者生理盐水。本领域普通技术人员将会理解，所述设置可允许钉成形插入件运动以便更好地适应被夹钳在钉施放组件16g中的组织的厚度变化。例如，对于具有相对恒定厚度的组织来说，液体432可相对均匀地分布在每个囊420、430中以提供对于钉成形插入件的相对均匀的支撑设置，见图31。但是，当遇到更厚的组织部分时，与更厚组织对应的那些钉成形插入件将被压缩到它们各自的砧座腔中，从而迫使该囊部分中的液体流到与更薄组织部分对应的囊部分中，见图32。
在一些应用中，可能需要医生能够控制囊420、430中的压强大小。例如，当切割并缝合更脆弱的组织诸如肺组织以及类似物时可能需要较小的压强。当切割并缝合较厚的组织例如诸如胃组织、肠组织、肾组织等时可能需要更大的压强。为了为医生提供这种额外的灵活性，囊420、430每个可都通过供应管线440或导管与由器械的手柄部分12支撑的流体容器450流体连接。在图33中示出的实施方式中，医生可通用过安装在流体容器450上的调节机构2增加或减少囊420、430中的流体量并增加和降低其中产生的压强。在各种实施方式中，调节机构460可包括与调节螺栓464连接的活塞462。通过向内调节调节螺栓464，活塞462迫使流体流出容器450并流到囊420、430。相反，通过反转调节螺栓464，活塞462允许更多流体432回到或保留在容器450中。为了帮助医生确定该液压系统(整体标记为405)中的压强大小，如图所示，可采用压强计470。因此，对于需要更大压强的组织来说，医生可将囊420、430中的压强预设到适于成功夹钳并缝合该特定类型的组织的压强。虽然已经描述了活塞/螺栓设置用于控制液压系统中的压强，但本领域技术人员将会理解，在不背离本发明的精神和范围的条件下，其他控制机构也可成功地被采用。
图30A示出了本发明的其他实施方式的另一种钉施放组件16h，其中钉成形插入件与砧座之间的偏压或者柔顺介质包括至少一个可压缩聚合物构件。更具体地说，如图30A中可以看到的那样，左侧可压缩聚合物构件420h被放置在位于砧座20h中的砧座槽58h的左侧上的左侧腔253h内。类似地，右侧可压缩聚合物构件430h被放置在砧座20h中的右侧腔263h中。一系列左侧钉成形插入件270h-300h可通过合适的粘合剂或者其他紧固件设置与左侧可压缩聚合物构件420h连接。类似地，一系列右侧钉成形插入件310h-340h可通过合适的粘合剂或者其他紧固件设置与右侧压缩聚合物构件430h连接。
图34-37示出了独特新颖的可收缩或者可压缩钉驱动器设置，其通过响应于在击发过程中驱动器受到的压缩力而收缩或者压缩使各种钉驱动器能够适应不同的组织厚度。在本文中，术语“击发过程”指的是向着砧座的钉成形下表面驱动钉驱动器的过程。如上面所提到的那样，现有钉驱动器由设置成当在击发过程中受到压缩力时抵抗偏转和变形的硬/刚性材料制成。各种这样的驱动器构造是已知的。例如，一些钉驱动器被构造成支撑单个钉，而其他钉驱动器被设置成支撑多个钉。单钉和双钉驱动器的讨论以及它们可怎样可操作地在钉仓中受到支撑并被击发在Frederick E.Shelton，IV于2005年9月9日提交的申请号为11/216562、题为Staple CartridgesFor Forming Staples Having Differing Formed Staple Heights的美国专利申请中记载，该专利申请的内容通过引用结合入本文。
图34示出了包括细长通道40h的钉施放组件16h，所述细长通道具有以公知的方式与其枢转连接的砧座20h。细长通道40h被构造成将钉仓42h可操作地支撑于其中。砧座20h上具有钉成形下表面60h，其适于当砧座20h被枢转到如图34中所示的闭合位置时面对钉仓42h的上表面43h。钉83每个都被支撑在相应钉驱动器500上，所述钉驱动器的构造将在下面进一步详细讨论。
每个钉驱动器500可运动地支撑在设置在仓主体85h中的相应钉通道87h中，如图34和35所示。还可操作地支撑在仓主体85h中的是驱动构件或者楔形滑动件78，其被定向以便在击发过程中由E形梁击发构件50接合，见图34。当E形梁击发构件50和楔形滑动件78以公知的方式经过细长通道40h和钉仓42h被向远侧驱动时，楔形滑动件78在仓主体85h中向上驱动钉驱动器500。当钉驱动器500向着砧座20h的钉成形下表面60h被向上驱动时，它们携带与它们一起的各自的一个或多个钉83，所述钉被驱动成与砧座20h的钉成形下表面60h中的相应钉成形凹窝61h成形接合。当钉83的端部88与成形凹窝61h接触时，它们被弯曲从而提供具有有些像“B”字形的形状的钉83。虽然在这里已经结合E形梁击发构件对本发明的各种实施方式进行了描述，但可以想到，在不背离本发明的精神和范围的条件下，这些不同实施方式也可成功地与不同击发构件和驱动构件设置一起被使用。
本发明的一种可收缩钉驱动器实施方式在图36和37中示出。从那些图中可以看出，可收缩或者可压缩钉驱动器500包括基座部分502和钉支撑部分520，所述钉支撑部分520可响应于在击发过程中产生的压缩力从第一未收缩位置相对于基座部分502运动。在各种实施方式中，基座部分502可具有前支承柱部分504和与前支承柱部分504间隔开并大体上与其一体形成的后支承柱部分508。基座部分502还可具有直立侧部510，所述直立侧部具有从其后侧突出的肋512。直立侧部510用于限定基座部分502中的接收凸缘514以便将钉支撑部分520接收于其上。本领域普通技术人员将会理解，当钉支撑部分520被接收在凸缘514上时，钉驱动器500不能进一步收缩或压缩。
钉驱动器500的钉支撑部分520同样可包括前支承柱部分522和与前支承柱部分522间隔开并大体上与其一体形成的后支承柱部分524。当钉支撑部分520被接收在基座部分502上时，前支承柱部分504、522用于形成前柱部分530，并且后支承柱部分508、524形成后柱部分532。前钉容纳槽526在前支承柱部分522中形成，后钉容纳槽528在后支承柱部分524中形成。前钉容纳槽526和后钉容纳槽528用于将钉83支撑于其中，如图35中所示。肋512和前柱530以及后柱532可与钉仓主体85中的相应通道(未显示)协作以提供对钉驱动器500的侧向支撑，同时允许在击发过程中驱动器在仓主体85内被向上驱动。
在各种实施方式中，设置阻抗连接结构(总体标记为540’)，以便在击发操作过程中受到任何压缩力之前支撑相对于基座部分(图37)处于第一未压缩或者未收缩的方位的钉支撑部分520，并且在钉击发操作过程中允许钉支撑部分520和基座部分响应于被施加到钉支撑部分520和基座部分502上的压缩力的大小彼此相向运动(收缩或压缩)。从图36和37中可以看出，在各种实施方式中阻抗连接机构540’可包括一对连接杆540，其从钉支撑部分520的底部521突出并与基座部分502中的洞或者孔542对应。相对于孔542设计杆540的尺寸和形状以在二者之间建立过盈配合或者“轻压配合”(即大约0.001英寸的过盈)，当在钉击发操作过程中钉支撑部分520和驱动器基座部分502被压缩到一起时(将在下面进一步详述)，使钉支撑部分520和基座部分502可彼此相向压缩以降低与击发过程中受到的压缩力大小有关的钉驱动器500的总高度。在各种实施方式中，例如，钉支撑部分520和基座部分502可由相同材料制成，例如诸如塑性材料，例如
Figure A20078004195300351
在其他实施方式中，基座部分502和钉支撑部分520可由不同材料制成。例如，钉支撑部分520可由
Figure A20078004195300352
制成，而基座部分502可由填充有玻璃或者矿物质的制成。但是，其他材料也可被采用。例如，基座部分502可由尼龙6/6或者尼龙6/12制成。
在各种实施方式中，可在连接杆540与它们的相应孔542之间建立大约0.001英寸的摩擦或者过盈配合。但是，其他程度的过盈配合可被采用以达到与在缝合特定类型/厚度的组织时受到的压缩力的大小成比例的所需驱动器压缩量和压缩率。例如，在一种实施方式中，连接杆540与它们各自的孔542之间的过盈配合程度可大约为0.002到0.005英寸以便缝合组织，其中在击发操作过程中可以预期2-5磅数量级的压缩力可被产生。
图35示出了当遇到变化厚度的组织时钉驱动器500可能获得的行进和压缩的各种范围。更具体地，图35示出了被夹钳在钉仓42h的上表面43h与砧座20h的钉成形下表面60h之间的一部分组织560。如图35所示，组织560具有三种厚度。最厚部分的组织被标记为562并构成在该图右侧的组织部分。下一厚度的组织部分被标记为564，最薄部分的组织560被标记为566并位于该图的左侧。为了该解释的目的，与组织部分562相关的钉驱动器被标记为钉驱动器500a。与组织部分564相关的钉驱动器被标记为钉驱动器500b，并且与组织部分566相关的钉驱动器被标记为钉驱动器500c。应当理解，钉驱动器500a、500b、500c在结构上可以是与上面描述的钉驱动器500相同的。
首先参见钉驱动器500a，当钉驱动器500a向着砧座20h的钉成形下表面60h由楔形滑动件(在图35中未显示)向上被驱动时，其遇到抵抗钉驱动器500a的向上运动的厚组织部分562。这样的阻力(由箭头570指示)与由楔形滑动件产生的驱动力(由箭头572指示)相反并用于克服在连接杆540与它们各自的孔542之间建立的过盈量并迫使杆540进入它们各自的孔542中更深，从而允许钉驱动器500a的钉支撑部分520a和基座部分502a彼此相向运动。在钉击发操作过程中产生的压缩力作用下的这种钉支撑部分520a和基座部分502a的彼此相向运动在这里被称为“收缩”或者“压缩”。当处于钉支撑部分520a被接收在基座部分502a的凸缘514a上的完全压缩位置中时，钉支撑部分520a上的钉支撑凸缘526a、528a可优选支撑钉仓42h的上表面43h上方的钉83的底部横梁89，以避免在钉施放组件16h被退出时勾住钉仓42h上的钉83。钉驱动器500a的压缩高度由图35中的箭头574指示。
接着参见与组织部分564对应的钉驱动器500b，由于组织部分564没有组织部分562那么厚，在击发操作过程中钉驱动器500b遇到的阻力570b也不像阻力570那么大。因此，钉驱动器500b的连接销540b行进到它们各自的孔542b中不如钉驱动器500a的销540行进到它们各自的孔542中那么远。因此，钉驱动器500b的压缩高度576大于钉驱动器500a的压缩高度574。从图35中可以看出，被支撑在钉驱动器500b中的钉83的底部89被支撑在钉仓42h的上表面43h上方。
钉驱动器500c与最薄的组织部分566相关。因此，在钉击发操作过程中钉驱动器500c遇到的阻力570c小于钉驱动器500b遇到的阻力570b。因此，钉驱动器500c的销540c行进到它们各自的孔542c中不如钉驱动器500b的销540b行进到它们各自的孔542b中那么远。因此，钉驱动器500c的压缩高度578大于钉驱动器500b的压缩高度576。
从图35中可进一步看出，由于钉驱动器500c的压缩高度578大于钉驱动器500b的压缩高度576，由钉驱动器500b支撑的钉83c被压缩到比由钉驱动器500b支撑的钉83b更大的程度。因此，钉83c的成形高度小于钉83b的成形高度，钉83b的成形高度比钉83a的成形高度小，如图35中所示。
本领域普通技术人员将会理解，在不背离本发明的精神和范围的条件下，连接杆以及它们各自的孔的数目、形状、组成和尺寸可依实施方式不同而变化。连接杆与它们各自的孔之间的相互关系用于建立它们之间的摩擦过盈量，与在夹钳/缝合不同厚度的组织时受到的各种压缩力相关地，所述过盈量可被克服。在替代方案中，连接杆540可在基座部分502上形成，并且孔可设置在钉支撑部分520中。
图38和39示出了本发明的另一种钉驱动器500d的实施方式，其在构造和操作上基本上可与上面描述的钉驱动器500相同，但连接杆540d略呈锥形或者截锥形形状。在各种实施方式中，例如，连接杆540d的端部541d可被设置成与孔542相关的尺寸，使得当处于图39中所示的第一未收缩状态时在它们之间建立轻压配合。连接杆540d的锥度可适于达到与在钉击发操作过程中受到的压缩力的大小有关的所需钉驱动器压缩量。因此，在这些实施方式中，当钉驱动器500d遇到将连接杆540d更深地驱动到它们各自的孔542d中的更大压缩力时，连接杆540d与孔542之间的过盈配合量增加。在替代实施方式中，连接杆540可具有圆形形状，并且孔542可成锥形以达到与在击发操作过程中被施加到其上的期望压缩力的大小成比例的所需钉驱动器压缩量和压缩率。在替代方案中，连接杆540d可在基座部分502上形成，并且孔542可在钉支撑部分520中形成。
图40-43示出了本发明的另一种钉驱动器500e实施方式，其在构造和操作上基本上可与上面描述的钉驱动器500相同，但连接杆540e被构造或者形成为包括被定向成在击发操作过程中当钉驱动器500e受到压缩力时被从杆的剩余部分上剪掉的额外量的材料。更具体地说，参照图42，连接杆540e具有被容纳在相应孔542e中的尖部541e。尖部541e可被设置成与孔542e相关的尺寸，使得在它们之间可实现滑动配合，或者在其他实施方式中，当处于第一未收缩位置中时在那些元件之间可建立小的过盈配合。每个连接杆540e的剩余部分543e可被提供或者形成有额外量的材料545e，所述额外量的材料被设计成当钉驱动器500e在击发操作过程中受到预期压缩力时从连接杆上被剪下，参见图43。额外的材料545e可完全围绕每个连接杆540e的部分543e的圆周延伸，或者材料543e可包括一个或多个围绕连接杆540e的圆周定向的部分。例如，在图40-43中所示的实施方式中，材料543e的两部分547e在每个连接杆540e上在直径上相对，如图所示。在各种实施方式中，部分之间的直径距离可略大于孔542e的直径，当钉驱动器500e在击发操作过程中受到预期压缩力时使部分547e从杆542e的至少一部分上被剪切或者被除去。
该部分额外材料543e可构成为连接杆540e的一体部分或者额外材料543e可包括被应用于连接杆540e上并被设计成当钉驱动器500e受到预期压缩力时从其上剪切下来的第二材料。在各种实施方式中，基座部分502可由比制成连接杆540e的材料刚性更大的材料制成，和/或额外材料543e可被制成当钉支撑部分520e和基座部分502e在钉击发操作过程中被压缩在一起时使基座部分502有利于将额外材料543e剪掉。在替代方案中，连接杆540e可在基座部分502上形成，并且孔542e可设置在钉支撑部分520e中。
图44-46示出了本发明的另一种钉驱动器500f的实施方式，其在构造和操作上基本上可与上面描述的钉驱动器500相同，但基座部分502f中的孔542f可以是六角形形状或者其中可具有被设计成建立与连接杆540的过盈配合或者阻抗连接杆540进一步进入孔542f中的一个或多个表面。例如，所显示的孔542f具有在其中形成的一对平面551f，用于建立连接杆540f与孔542f之间的过盈配合或者一定程度的摩擦阻力，所述过盈配合或者一定程度的摩擦阻力可被在夹钳/缝合不同厚度的组织时受到的各种压缩力克服。在图44-46所示的实施方式中，连接杆540具有大体上圆形的横截面形状并且孔542f具有在其中形成的平面551。但是，在替代实施方案中，孔542可为圆形的并且平面被形成在连接杆540上。在替代方式中，连接杆540可设置在基座部分502f上并且孔542f可设置在钉支撑部分520中。
图47-49示出了本发明的另一种钉驱动器500g，其包括基座部分502g和钉支撑部分520g。钉支撑部分520g具有在其中形成的钉支撑槽(未显示)和从其下表面521g突出的向下突出的柄脚580。柄脚580具有两个斜面582并且其形状设置成被容纳在基座部分502g中形成的相应腔590中。腔590形成有倾斜侧面592并且其尺寸设置成将柄脚580以下面的方式容纳在其中。当驱动器钉500g受到在击发操作过程中产生的压缩力时，柄脚580被迫进入腔590中。图49示出了处于完全收缩或者压缩位置中的钉驱动器500g。钉支撑部分520g和/或柄脚580可由比制成基座部分502g的材料略微更柔顺的材料制成，使柄脚580可被迫进入基座部分502g中的腔590中，而基本上不使基座部分502g扭曲到可能妨碍钉驱动器500g被完全驱动到最终击发位置的能力的程度。例如，钉支撑部分和/或柄脚580可由
Figure A20078004195300391
制成，而基座部分502g可由玻璃填充的尼龙制成以达到在击发操作过程中受到预期压缩力时所需的驱动器压缩量。在替代方案中，柄脚580可被设置在基座部分502g上并且孔590可被设置在钉支撑部分520g中。
图50-52示出了本发明的另一种钉驱动器500h实施方式，其在构造和操作上基本上可与上面描述的钉驱动器500相同，但代替连接杆的是，钉支撑部分520h具有两个从其上突出的锥形柄脚600，所述柄脚被设计成被压缩到在基座部分502h中形成的V形腔610中。在击发操作开始之前，钉支撑部分520h被支撑在钉仓中的基座部分502h上。当在击发操作过程中钉支撑部分520h和基座部分502h被压缩在一起时，锥形柄脚600被迫向内，如图52所示。柄脚600被压缩到V形腔610中的程度取决于在击发过程中受到的压缩力的大小。
钉支撑部分500h和/或柄脚600可由比制成基座部分502h的材料略微更柔顺的材料制成，使柄脚600可被迫进入基座部分502h中的V形腔610中，而基本上不使基座部分502h扭曲到可能妨碍钉驱动器500h被完全驱动到最终击发位置的能力的程度。例如，钉支撑部分和/或柄脚600可由没有填充的尼龙制成，而基座部分502h可由填充了玻璃或者矿物质的
Figure A20078004195300401
制成以达到在击发操作过程中受到预期压缩力时所需的钉驱动器压缩量。在替代方案中，柄脚600可被设置在基座部分502h上并且腔610可被设置在钉支撑部分520h中。
图53-55示出了本发明的又一种钉驱动器500i的实施方式，其包括其中具有V形钉支撑槽630i、650i的钉支撑部分520i。在该实施方式中，钉支撑部分520i具有第一对620i从其上突出且被定向成被压进第一V形槽或腔630i中的两个锥形柄脚622i、626i，和第二对640i从其上突出且被定向成被压进第二V形槽或腔650i中的两个锥形柄脚642i、646i。更具体地说，参见图54，第一柄脚622i具有端部624i，其在钉击发操作开始之前与第二柄脚626i的端部628i间隔开。当处于图54所示的位置时，端部624i、628i被向外偏压成与第一V形槽630i的上侧壁摩擦接触以将钉支撑部分520i保持在如图54中所示的未收缩位置。虽然没有显示，但第二对640i柄脚642i、646i也类似于柄脚622i、626i那样被构造并用于以相同的方式接合第二V形槽650i。
当钉支撑部分520i和基座部分502i在击发操作过程中被压缩在一起，第一柄脚622i、626i的端部624i、628i和第二柄脚642i、646i的端部被彼此相向偏压以允许柄脚被更深地驱动到它们各自的槽630i、650i中。图55示出了处于它们的完全压缩状态下的第一对620i柄脚622i、626i，所述状态也与驱动器500i的完全压缩状态对应。柄脚被压缩到它们各自的V形槽中的程度取决于在击发过程中受到的压缩力的大小。
钉支撑部分520i和/或柄脚622i、626i、642i、646i可由比制成基座部分502i的材料略微更柔顺的材料制成，使柄脚622i、626i、642i、646i可被迫进入基座部分502i中它们各自的V形槽中，而基本上不使基座部分502i扭曲到可能妨碍钉驱动器500i被完全驱动到最终击发位置的能力的程度。例如，钉支撑部分502i和/或柄脚622i、626i、642i、646i可由
Figure A20078004195300411
制成，而基座部分502i可由填充了玻璃或者矿物质的尼龙制成以达到在击发操作过程中受到预期压缩力时所需的钉驱动器压缩量。在替代方案中，柄脚622i、626i、642i、646i可被设置在基座部分502i上并且V形槽630i、650i可被设置在钉支撑部分520i中。
上面描述的本发明的各种实施方式以及它们各自的等同结构代表了对现有钉施放组件和端部执行器的巨大改进。本发明的各种实施方式提供了砧座和/或具有柔性部分的通道，所述柔性部分允许钉的总高度随着组件中的压缩由于组织厚度引起的增大而增加。其他实施方式采用具有可响应于组织厚度的变化被压缩离开钉仓的柔性成形凹窝的砧座设置。在这样做时，成形凹窝与仓之间的固有间隙增加，用于增大钉成形高度。这些优点可提高钉线一致性并提供更好的临床结果。
图56-63示出了本发明的另一种外科缝合和切割器械1000。如同从图56可以看到的那样，器械1000包括可被操作以放置执行部分1014的手柄组件1020，所述执行部分包括在远侧连接到细长轴组件1100上的紧固端部执行器，图示为钉施放组件1016。执行部分1014的大小设置成，在钉施放组件1016的上钳口(砧座)1050和下钳口1018通过向着手柄组件1020的手枪式把手1034压下闭合扳机1040(这推进细长轴组件1100的外侧闭合套筒1130以枢转砧座1050到闭合位置，将在下面进一步详细描述)而被闭合的条件下，该尺寸能够通过套管针的套管(未显示)插入，用于内窥镜或腹腔镜外科手术。
一旦被插入到吹注气体的的体腔或者腔中，闭合扳机1040就可被释放，打开砧座1050，于是组织被夹持并定位。一旦对保持在钉施放组件1016中的组织感到满意，医生就按压闭合扳机1040直到该闭合扳机1040抵靠手枪式把手1034被锁定，将组织夹钳在钉施放组件1016的内部。然后击发扳机1046向着闭合扳机1040和手枪式把手1034被拉动，从而施加击发力或者运动给击发扳机以从未击发位置向远侧推进被支撑在执行部分1014中的击发构件。当击发构件以公知的方式行进通过执行部分或者端部执行器1014时，其切割被夹钳在端部执行器1014内的组织并击发或驱动包含在钉仓42中的钉。
如图57所示，该实施方式可采用上面描述的击发杆36和E形梁50设置。在其他替代实施方式中，也可采用在2005年9月21日提交的申请号为11/231456、题为“Surgical Stapling InstrumentHaving Force Controlled Spacing End Effector”的美国专利申请中描述的E形梁设置，该专利申请的公开内容通过引用结合入本文。另外，如在本具体实施方式中描述的那样，本领域普通技术人员将会理解，当与其他已知的非E形梁击发杆构造结合使用时由本发明的这些实施方式所提供的优点可有效地被获得。因此，本发明的这些实施方式不应当被仅仅限制为与E形梁型击发和切割设置结合使用。
图57示出了击发杆36，其包括近侧击发杆34，近侧击发杆34被支撑在连接手柄组件1020与钉施放组件1016的“机架底”或者脊组件1110中。在钉击发运动过程中，击发杆36接合细长钉通道1060并致动包含在其中的钉仓42，钉通道和钉仓二者都以上面描述的各种方式形成下钳口1018。
用于将致动力施加到击发杆36上以使击发杆36通过钉施放组件1016线性行进和回缩的各种不同击发设置是已知的。所述击发运动可手动产生，诸如通过使用在Frederick E.Shelton，IV等人于2006年6月27日提交的申请号为11/475412、题为“Manually DrivenSurgical Cutting and Fastening Instrument”的美国专利申请中公开的各种击发系统设置，该专利申请的公开内容通过引用结合入本文。还有其他致动系统，诸如在Frederick E.Shelton，IV等人于2006年8月2日提交的申请号为11/497868、题为“PneumaticallyPowered Surgical Cutting and Fastening Instrument With aVariable Control of the Actuating Rate of Firing WithMechanical Power Assist”的美国专利申请中公开的气动致动系统也可成功地被采用，该专利申请的公开内容通过引用结合入本文。其他实施方式可包括，例如，在Frederick E.Shelton，IV等人于2006年1月31日提交的申请号为11/343562、题为“Motor-DrivenSurgical Cutting and Fastening Instrument With ArticulatableEnd Effector”的美国专利申请中公开的电动马达驱动的致动系统，该专利申请的公开内容通过引用结合入本文。还有其他实施方式可包括在不背离本发明的精神和范围的条件下的其他已知的机械、电、液压和/或气动致动击发系统。
在各种实施方式中，细长轴组件1100包括被接收在脊组件1110上的闭合管组件1130，参见图57。脊组件1110可包括单个构件或者其可包括具有安装于其中的关节运动接头(未显示)的多个部分。所述关节运动接头在本领域是已知的，并且例如可以是机械、电、液压或者气动控制的。在图57和58中示出的实施方式中，脊组件1110包括近侧部分1112(图58)和远侧部分1116(图57)。如同将在下面讨论的那样，近侧部分1112可与手柄组件1020连接，使闭合管组件1130可在其上轴向运动以引起砧座1050在打开和闭合位置之间枢转。如同在图57中可以看到的那样，细长通道1060具有在近侧设置的连接腔1062，每个连接腔容纳相应通道锚固构件1118，通道锚固构件1118在远侧脊部分1116的远端上形成。细长通道1060还具有细长砧座凸轮槽1064，其可运动地容纳砧座1050上的相应砧座耳轴1052(将在下面进一步详细讨论)。
闭合管组件1130可包括远侧闭合管部分1140和近侧闭合管部分1150。远侧闭合管部分1140和近侧闭合管部分1150可由聚合物或者其他合适的材料制成。远侧闭合管部分1140和近侧闭合管部分1150每个都是中空的以便将脊组件1110的相应部分容纳在其中。闭合管组件1130被图示为包括两个独立部分1140和1150以便于整个细长轴组件1100的组装。那些部分1140和1150可在组装后通过粘合剂或者其他合适的紧固方法连接在一起。但是可以想到，闭合管组件1130可被制成为一体式。另外，如上所述，本发明的各种实施方式的脊组件可具有安装在其中的关节运动接头。对于那些实施方式，双枢轴闭合接头(未显示)可在闭合管组件1130中被采用。所述双枢轴闭合设置的例子在已通过引用结合入本文的申请号为11/497868的美国专利申请中公开。
使用时，闭合管组件1130向远侧平移以闭合砧座1050，例如响应于闭合扳机1040的致动。砧座1050通过在脊组件1110上向远侧平移闭合管组件1130而被闭合，引起远侧闭合管部分1140中的马蹄形孔1142的后侧撞击位于砧座1050上的打开/闭合翼片1052形式的闭合部件1053并引起闭合部件1053枢转到闭合位置，见图57。为了打开砧座1050，闭合管组件1130在脊组件1110上沿着近侧方向轴向运动，引起远侧闭合管部分1140上的翼片1144接触砧座1050上的打开/闭合翼片1054并推靠该打开/闭合翼片1054，将砧座1050枢转到打开位置。
图58示出了本发明的各种实施方式的非限制性手柄组件1020的分解组装图，其中为清楚起见各种击发系统元件已经被省去。在图58中示出的实施方式中，手柄组件1020具有“手枪式把手”构造并由右侧壳构件1022和左侧壳构件1028形成，这两个构件由聚合物或者其他合适材料模制成或者以其他方法制成并被设计成配合在一起。所述壳构件1022和1028可通过模制或者以其他方式在其中形成的卡扣部件、栓钉和插座，和/或通过粘合剂、螺钉、螺栓、夹具等连接在一起。右侧壳构件1022的上部1024与左侧壳构件1028的相应上部1030配合以形成被标记为1031的基本外壳部分。类似地，右侧壳构件1022的下握持部1025与左侧壳构件1028的下握持部1032配合以形成整体标记为1034的握持部分，参见图56。但是，本领域普通技术人员将会很容易理解，手柄组件1020可以各种不同形状和尺寸提供。
出于清楚的目的，图58仅仅示出了用于控制闭合管组件1130的轴向运动的元件，该闭合管组件最终控制砧座1050的打开和闭合。从该图可以看出，通过连接组件1180与闭合扳机1040连接的闭合梭1160被支撑在基本外壳部分1031中。闭合梭1160还可以两部分1162、1164的方式制成，该两部分由聚合物或者其他合适材料被模制或者以其他方式制成并被设计成配合在一起。例如，在图58、60和61所示的实施方式中，右侧部分1162可被提供有紧固柱1163，紧固柱1163被设计成被容纳在左侧部分1164中的相应插座1167(图61)中。右侧和左侧部分1162、1164可通过卡扣构件和/或粘合剂和/或螺栓、螺钉、夹具等保持在一起。从那些图中可以看出，保持槽1152设置在近侧闭合管部分1150的近端1151中。闭合梭1160的右侧部分1162具有右侧保持凸缘1165(图60)，所述凸缘适于与闭合梭1160的左侧部分1164协作，使保持凸缘1165延伸到位于近侧闭合管部分1150中的保持槽1151中。保持凸缘1165用于将闭合管组件1130连接到闭合梭1160上，同时有利于其相对于闭合梭的有限轴向运动(将在下面进一步详细讨论)。
从图58中还可以看出，右侧脊组件保持栓钉1027从右侧壳构件1024向内突出，所述栓钉1027突入位于闭合梭1160的右侧部分1162中的细长槽或窗1166中。类似的闭合梭保持栓钉(未显示)从左侧壳构件1028向内突出以被容纳在设置在闭合梭1160的左侧部分1164中的另一窗或槽1168中。保持栓钉被构造成延伸到位于近侧脊部分1110的近端1114中的孔1115中，以将脊部分1110以不可运动的方式连接到手柄组件1020上，同时允许闭合梭1160相对于其轴向运动，见图58。保持栓钉可与近侧脊部分1112的近端1114机械连接，例如通过螺栓、螺钉、粘合剂、卡扣部件等连接。另外，闭合梭1160被提供有横向延伸出的导轨1170、1172。导轨1170被构造成滑动地容纳在位于右侧壳构件1024中的导轨引导件1026内，并且导轨1172被构造成滑动地容纳在位于左侧壳构件1028中的导轨引导件(未显示)内，见图58。
闭合梭1160和闭合管组件1130沿着远侧方向(箭头“A”)的轴向运动通过使闭合扳机1040向着手柄组件1020的握持部1034运动来产生，闭合梭1160沿着近侧方向(箭头“B”)的轴向运动通过使闭合扳机1040远离握持部1034地运动产生。在各种实施方式中，闭合梭1160设置有便于闭合连接组件1180与其连接的连接翼片1174，见图58和59。闭合连接组件1180包括通过销1184枢转销接到连接翼片1174的轭部1182。闭合连接组件1180进一步具有闭合臂1186，其通过闭合销1188枢轴销接到在闭合扳机1040上形成的轭组件1043，如图58所示。闭合扳机1040通过在右侧壳构件1024与左侧壳构件1028之间延伸的枢轴销1189枢转安装在手柄组件1020内。
当医生希望闭合砧座1050以将组织夹钳在端部执行器1014内时，医生向着手枪式把手部分1034拉动闭合扳机1040。当医生向着手枪式把手部分1034拉动闭合扳机1040时，闭合连接组件1180使闭合梭1160沿着远侧“A”方向运动，直到闭合连接组件1180运动到图59中示出的锁定位置中。当处于该位置时，闭合连接组件1180将闭合梭1160保持在锁定位置中。
在各种实施方式中，为了进一步将闭合梭1160保持在闭合位置中，闭合扳机1040可被设置有可释放锁定机构1190，该可释放锁定机构1190适于接合手枪式把手部分1034并可释放地将闭合扳机1040保持在锁定位置中。其他锁定装置也可被用于可释放地将闭合梭1160保持在锁定位置中。
在图59所示的实施方式中，闭合扳机1040包括纵向柔性臂1192，所述纵向柔性臂包括从其上延伸的侧销1194。臂1192和销1194例如可由模制塑料制成。手柄组件1020的手枪式把手部分1034包括开口1036，在该开口1036中设置有横向延伸出的楔形件1037。当闭合扳机1040被回缩时，销1194接合楔形件1037，并且销1194由楔形件1037的下表面强迫向下(即臂1192顺时针旋转)。当销1194完全经过下表面时，臂1192上的沿顺时针方向的力被除去，并且销1194逆时针旋转，使销1194靠在位于楔形件1037后面的切口1038中，从而锁定闭合扳机1040。销1194通过从楔形件1037延伸出的柔性止动器1039进一步保持在锁定位置中。
为了解锁闭合扳机1040，操作人员可进一步挤压闭合扳机1040，引起销1194接合开口1036的倾斜后壁1041，迫使销1194向上通过柔性止动器1039。销1194然后自由行进离开开口1036，使闭合扳机1040不再锁定到手枪式把手部分1034。所述设置的进一步细节可在Shelton，IV等人于2006年1月31日提交的申请号为11/344020、题为“Surgical Instrument Having A Removable Battery”的美国专利申请中找到，该文献的相关部分通过引用结合入本文。其他可释放锁定设置也可被采用。
当闭合梭1160运动到锁定位置时，闭合管组件1130在脊组件1110上向远侧运动，引起砧座1050上的闭合/打开翼片1054被远侧闭合管部分1140中的马蹄形孔1142的近端接触，从而将砧座1050枢转到闭合(夹钳)位置。因此，在夹钳操作过程中由砧座1050达到的夹钳力最终取决于当闭合管组件接触砧座1050上的翼片1054时由闭合管组件产生的闭合力(在图62和63中由箭头1196表示)。如上面讨论的那样，现有闭合管设置缺少用于限制被施加到砧座1050的闭合/打开翼片1054的致动力的大小的部件。
本发明的各种实施方式通过包括用于限制由闭合管组件施加到砧座的闭合/打开翼片1054的闭合力或负载的大小的力限制构件1200，解决了现有闭合管设置的所述缺点。例如，在一种实施方式中，力限制构件1200可包括被定向在近侧关闭管部分1150的近端1151附近的缓冲构件1210。更具体地说并参见图60和61，缓冲构件1210包括可被支撑在闭合梭1160中形成的腔1169中的波形弹簧组件1212。波形弹簧组件1212可被支撑在连接柱1163与近侧闭合管部分1150的近端1151之间。在各种实施方式中，波形弹簧1212可以附图中示出的形式由弹簧钢制成。但是，其他缓冲设置或者柔顺构件设置例如诸如由橡胶、弹性体、聚合物、泡沫橡胶等制成的构件可成功地被用于为闭合管组件1130提供一些沿着近侧方向轴向运动的自由，以降低在砧座闭合过程中最终被施加到砧座1050上的夹钳力(将在下面进一步详细讨论)。
如同从图60和61中看到的那样，近侧闭合管部分1150中的保持槽1152包括直径小于近侧闭合管部分1150的外径的区域1154。区域1154沿轴向延伸以便规定闭合管组件1130相对于闭合梭1160沿轴向向远侧运动一段距离，该段距离由保持槽1152的轴向长度(图60中的箭头1155)限定。
在该实施方式中，当闭合扳机1040向着手枪式把手部分1032运动时，闭合梭1160沿着远侧方向(箭头A)行进。当闭合梭1160向远侧运动时，闭合管组件1130也被向远侧推动。如图62和63中可以看到的那样，远侧闭合管部分1140的远端1141被定向成沿着砧座1050的斜坡部分1070沿轴向运动。当远端1141接触砧座斜坡1070并继续沿着斜坡向远侧运动时，远端1141将闭合力施加到砧座1050上。砧座耳轴1052被容纳在位于细长钉通道1060的近端中的相应“肾形”槽1064中并用于在所需闭合路径中导引砧座1050，所述路径导致砧座1050的钉成形下表面与钉仓42的上表面之间的组织夹钳。当砧座1050接触组织时，所产生的阻力被传递到砧座1050并最终被传递到远侧闭合管部分1140的远端1141。所述阻力的大小受到被夹钳组织厚度的影响。与较厚的组织相比，较薄的组织将施加较小的阻力。但是，当受到阻力时，缓冲构件1210使闭合管组件1130能够向近侧运动，以最终限制由闭合管组件1130施加到砧座1050上的闭合力的大小。
对于各种厚度和类型的组织的阻力大小可被确定，并相应地设计波形弹簧1212的尺寸，使所需大小的夹钳力被施加到砧座1050与钉仓42之间的组织上。波形弹簧1212的尺寸和方位可被设置成当砧座1050处于完全压缩位置时，波形弹簧1212不是完全被压缩或者“降至最低点”。
图64和65示出了可被采用以限制施加到砧座1050上的闭合力的闭合管组件的其他方案。如同从那些图中可以看到的那样，力限制构件1200a、1200b包括实际上分别形成于远侧闭合管部分1140a、1140b中的弹簧部分1212a、1212b。虽然弹簧部分1140a、1140b被图示为本质上有些螺旋并在远侧闭合管部分1140a、1140b中形成，但本领域普通技术人员将会理解，弹簧部分1212a、1212b可在闭合管组件1130a、1130b的任何部分中提供，并且可以想到以不同构造被提供。本领域普通技术人员将会理解，在这些实施方式中，近侧闭合管部分中的保持槽1152可以不是细长的，使闭合管组件1130a、1130b基本上不能相对于闭合梭1160沿轴向运动。另外，虽然仅仅显示在闭合管组件中提供了一个弹簧部分，但应当理解，可在单个闭合管组件中形成一个以上的弹簧部分。与上面描述的方案相同，当在夹钳过程中遇到阻力时，弹簧构件1212a、1212b使它们各自的闭合管组件1130a、1130b能够向近侧运动以最终限制被施加到砧座1050上的闭合力的大小。
图66和67示出了可被采用以限制施加到砧座1050的闭合力的本发明的各种实施方式的另一闭合管组件。如同从那些图中可以看到的那样，力限制构件1200c包括在远侧闭合管部分1140c的远端1141中形成的弹簧片1212c。当闭合管组件1130c被致动向远侧运动以闭合砧座1050时，弹簧片1212c沿着砧座斜坡1070行进并径向(图67中的箭头1214)和轴向(图66中的箭头1216)自由运动。与上面描述的方案相同，当在夹钳过程中遇到阻力时，弹簧片1212c使闭合管组件1130c能够向近侧运动(箭头B)以最终限制被施加到砧座1050上的闭合力的大小。
图68和69示出了可被采用以限制由闭合管组件1130施加到砧座1050的闭合力的本发明的另一种实施方式。如同从那些图中可以看到的那样，该实施方式采用具有阶梯形斜坡1070的砧座1050d，所述阶梯形斜坡由远侧闭合管部分1140的远端1141接合。特别是，在那些图中示出的砧座1050d具有在其中形成的一系列阶梯1074d、1076d、1078d、1080d。当闭合管组件1130向远侧运动时，远端141开始沿着斜坡1070的平滑部分1072d行进直到其接触第一阶梯1074d。闭合管组件1130将不再进一步沿着斜坡1070d行进以将更大的闭合力施加到砧座上，直到被施加到闭合管组件1130的致动力达到足够大以使远端1141升高到第一台阶1074d上并继续接合下一台阶1076d。闭合管组件1130不会进一步沿着斜坡1070d行进，直到致动力的大小足够大，使得远端1141突然升到第二阶梯1076d上，，此时远端1141将接合下一阶梯1078d，如此类推。因此，阶梯形砧座1050d与闭合管组件1130协同以提供基于在夹钳过程中由闭合管组件1130产生并由此而受到的阻力的大小将最终施加到砧座1050d与钉仓42之间的组织的夹钳力的大小关联的部件。虽然公开了四个所述阶梯，但其他阶梯数也可被采用。例如，可使用仅仅一个所述阶梯，或者二、三或四个以上的阶梯也可设想被采用。
图70-76示出了本发明的各种实施方式的另一种独特新颖的内切割器执行部分1014e，其包括细长通道1060e和相对于组织厚度“自我调节”的砧座1050e设置。在各种实施方式中，砧座1050e的近端通过安装构件可枢转地连接到细长通道1060e的近端，所述安装构件可包括可运动地容纳在形成于细长通道1060e的近端1061e中的相应细长槽1064e中的耳轴1052e。从图70-74中可以看出，在细长通道1060e的每侧上的槽1064e(在图70-74中仅仅示出了一个槽1064e)中的至少一个，优选为两个槽1064e每个都具有端壁1065e，所述端壁具有在其中形成的形式为定位槽或者枢轴窝1066e、1067e、1068e、1069e的多个离散的预定位置。从这些图中可以看出，定位槽1066e、1067e、1068e、1069e的每个均可包括V形切口，这些切口适于以就座的方式容纳在相应耳轴1052e上形成的爪1080e的尖端。可以想到，其他定位槽和爪构造也可成功地被采用。如同从图70-74中可以看到的那样，该实施方式可进一步包括用于将向下的偏压力施加到砧座1050e的近端1055e的弹簧片1090或者其他合适的偏压构件。在各种实施方式中，弹簧片1090可与脊组件1110的远侧部分1116连接并被定向成支承在砧座1050e的近端1055e上。
如同从图74中看到的那样，相对于耳轴1052e设计槽1064e的大小，以允许耳轴1052e响应于被夹钳在砧座1050e与仓42之间的组织厚度和对砧座1050e进行的闭合运动施加而找到不同的夹钳高度。弹簧片1090用于将爪1080e偏压到略微向上的位置中，在该位置中爪可被容纳在切口1066e、1067e、1068e、1069e中的任何一个中。当砧座1050e通过以上面描述的方式向远侧推进闭合管组件1130而被闭合在组织上时，组织厚度本身可决定爪1080最终以坐置的方式与切口1066e、1067e、1068e、1069e中的哪一个接合。由于弹簧片1090向上偏压带尖端的爪，当没有组织位于砧座1050e与仓42之间时爪1080会找到最上部的切口1069e，这可将端部执行器1014e夹钳在最紧密闭合位置，见图71和74。但是，如果在夹钳过程中，砧座1050e和通道1060e受到阻力，弹簧片1090会被压缩并且砧座耳轴1052e将找到较低的枢轴切口，这可最终导致砧座1050e与仓42之间的更大间隙。
图70示出了处于打开位置中的砧座1050e。图71示出了处于其最紧密闭合位置中的砧座1050e。仓42与砧座1050e的下侧1051e之间的组织夹钳空间或者距离被标记为“t”。图75也示出了砧座1050e相对于钉仓42和具有厚度“t”的组织1092的位置。类似地，图73示出了处于其最上部夹钳位置的砧座1050e，其中仓42与砧座1050e的下侧1051e之间的距离被标记为“T”。图76也示出了砧座1050e相对于钉仓42和具有厚度“T”的组织1094的位置。如同从图75和76中看到的那样，较薄组织1092中的钉83比延伸穿过更厚组织1094的钉83更紧密地成形。
图77-88示出了可与圆形缝合器1600结合使用的本发明的另一种实施方式，所述圆形缝合器包括用于限制可在砧座与钉仓之间产生的压缩力的大小的独特新颖设备以避免待缝合组织的过度压缩和可能破坏。各种不同圆形缝合器在本领域是已知的。图77-88示出了可采用本发明各个方面的优点的示例性圆形缝合器设置。但是可以想到，在不背离本发明的精神和范围的条件下，本发明的各种实施方式可成功地与其他缝合器构造一起使用。
如同在图77中看到的那样，所公开的圆形缝合器1600包括头部1610、砧座1700、调节用调节器组件1800和扳机1664。头部1610通过弧形轴组件1630与手柄组件1660连接。扳机1664由手柄组件1660可枢转地支撑，并且当保险机构1670被释放时扳机1664动作以操作缝合器1600。如同将在下面进一步详细讨论的那样，当扳机1664被致动时，击发机构(在图77中未显示)在轴组件1630内操作，于是钉1618从头部1610被排出并与砧座1700进入成形接触。同时，可操作地支撑在头部1610内的刀1620动作以切割保持在被缝合组织的圆周内的组织。缝合器1600然后穿过组织被拉出而将被缝合组织留在其位置中。
图78示出了可与本发明的各种实施方式结合使用的一种形式的砧座1700和头部1610。如同从该图中看到的那样，砧座1700可具有圆形主体部分1702，所述圆形主体部分具有用于将其与套管针连接的砧座轴。砧座主体1702上具有钉成形下表面1706，并且砧座主体1702还可具有与其远端连接的护罩1708。砧座1700还可设有一对套管针保持夹具或者叶片型弹簧1710，用于可释放地保持套管针1644与砧座轴1704保持地接合(将在下面进一步详细讨论)。在图78所示的实施方式中，塑料刀板1714可配合在砧座主体1702的腔1712中。
从图78中还可以看出，头部1610可包括将形式为圆形钉驱动器组件1614的仓支撑组件支撑于其中的壳构件1612，所述圆形钉驱动器组件适于与圆形钉仓1616连接并驱动支撑于钉仓中的钉1618与砧座1700的钉成形下表面1706进入成形接触。圆形刀构件1620也可设置在钉驱动器组件1614内的中央。壳构件1612的近端可通过远侧套环构件1632与弧形轴组件1630的外部管状护罩1631连接。
图79-82示出了可与本发明的各种实施方式一起采用的弧形轴组件1630的一种形式。从图79和80中可以看出，弧形轴组件1630可包括压缩轴1634、远侧压缩轴部分1635、顶部张紧带1636、底部张紧带1638和间隔带1640，它们被组装在外部管状护罩1631内(图80)。套管针尖端1644可通过紧固件1646与顶部张紧带1636和底部张紧带1638连接。顶部张紧带1636和底部张紧带1638的近端可与调节轴1650的远端连接。从图80中可以看出，套管针尖端1644可被插入到砧座1700的砧座轴1704中并由套管针保持夹具1710保持接合。
从图80中可以看出，远侧压缩轴部分1635与钉驱动器组件1614连接。因此，压缩轴1634在外部管状护罩1631内的轴向运动引起钉驱动器组件1614在壳构件1612内轴向运动。如同下面讨论的那样，击发扳机1664的致动可引起压缩轴1634沿着远侧方向(箭头“DD”)运动，从而向远侧驱动钉驱动器组件1614以击发钉1618，使钉进入与砧座1700的钉成形下表面1706的成形接触。当钉驱动器组件1614被向远侧驱动时，其也将刀1620的远端1622驱动穿过保持在被缝合组织的圆周内的组织、进入安装在砧座1700中的刀板1714中。刀板1714可由塑性材料或者其他合适材料制成，所述材料可允许刀1620的锋利远端1622穿透被夹钳组织并实现所需切割动作。
在各种实施方式中，调节轴1650可轴向运动地支撑在手柄组件1660内，所述手柄组件可包括通过合适的紧固件设置相互连接在一起以便于组装的两个手柄壳部分1661、1662。扳机1664通过枢轴销1666与手柄组件1660枢转地连接。弹簧1668被支撑在枢轴销1666上并用于将扳机1664从手柄组件1660偏压离开并到达未致动位置。保险轭1670通过销1672与扳机组件1664枢转连接，使保险轭1670能够在安全位置和不工作位置之间枢转，其中在安全位置中，扳机1664不能向着手柄1660被按压，在不工作位置中保险轭1670不能阻止扳机组件1664向着手柄组件1660枢转行进。如同在图79中可以看到的那样，扳机1664可具有一对翅片1665，它们的尺寸设置成被容纳在位于击发夹具1674中的槽1676中，击发夹具1674通过突起1639或者其他合适的紧固件设置与压缩轴1634的近端1637连接。如同将在下面进一步讨论的那样，所述设置通过枢转扳机1664允许压缩轴1634的向远侧轴向运动(箭头“DD”)和向近侧轴向运动(箭头“PD”)。扳机1664、压缩轴部分1634、1635和击发盖1674以及其他相关元件可构成总体标记为1675的击发组件。
如同在图79和81中可以看到的那样，调节轴1650具有与顶部和底部张紧带1636、1638连接的远侧部分1651，以及通过直径减小部分1653与远侧部分1651连接的近侧部分1652。近侧部分1652轴向容纳在位于远侧闭合螺母1720中的轴向通道1722内，所述远侧闭合螺母键连接到或者以其它方式连接到近侧闭合螺母1740上，以形成总体标记为1721的闭合螺母组件，从而使远侧闭合螺母1720和近侧闭合螺母1740可一起旋转。远侧闭合螺母1720可进一步具有向远侧延伸的套节部分1724，套节部分1724抵接在手柄组件1660内部形成的向内延伸的保持凸缘1667上，见图81。所述设置允许远侧闭合螺母1720在手柄组件1660内自由旋转，但不能在手柄组件内轴向运动。同样地，调节轴1650的近侧部分1652被轴向容纳在位于近侧闭合螺母1740内的轴向通道1742内。沿周向延伸的槽1744可设置在近侧闭合螺母1740的外表面中，以容纳在手柄组件1660的近端上形成的向内突出的近侧保持凸缘1669。所述设置用于允许近侧闭合螺母1740相对于手柄组件1660自由旋转。
同样在各种实施方式中，闭合调节器组件1800与近侧闭合螺母1740的近端1741连接。例如在一种实施方式中，近侧闭合螺母1740的近端1741可形成有向近侧延伸的锥形套节部分1746，其适于以不可旋转的方式容纳在位于离合器套节部分1830中的轴向通道1832中，见图81。锥形套节部分1746还形成有键或者键条设置，以便以不可旋转的方式将套节部分1746连接到离合器套节部分1830。可采用其他紧固件设置和方法，以便以不可运动方式将近侧闭合螺母1740的套节部分1746连接到离合器套节部分1830。因此，离合器套节部分1830的旋转将引起近侧闭合螺母1740和远侧闭合螺母1720也旋转。
从图81、83和84中还可以看出，调节器组件1800可进一步包括近侧盖部1810和远侧盖部1820。离合器套节部分的近端1831可被容纳在形成于近侧盖部1810的远端中的圆形槽1814中。槽1814的尺寸可被设置成允许近侧盖部1810围绕离合器套节部分1830的近端1831旋转。另外，近侧盖部1810可具有可旋转地延伸到位于离合器套节部分1830中的轴向通道1832中的突起1812。同样在各种实施方式中，闭合调节器组件1800可包括刚性且以不可旋转的方式连接到近侧盖部1810的远侧盖部1820。本领域普通技术人员将会理解，闭合调节器组件1800可以由多个部件制成，以便于器械的各种元件的组装。在各种实施方式中，近侧盖部1810和远侧盖部1820的配合端可被构造成具有互补的凸缘部分1813、1823，分别如图81和83中所示，互补的凸缘部分1813、1823通过粘合剂、焊接等相互连接，或者其他紧固件设置也可被采用。因此，当紧固在一起时，近侧盖部1810和远侧盖部1820作为一个单元一起旋转。
从图81和83中可以进一步看到，各种实施方式可包括总体标记为1821的滑动离合器组件。滑动离合器组件1821可采取由调节用调节器组件1800支撑或者在调节器组件1800中一体形成的各种形式。在一种实施方式中，例如，远侧盖部1820可被设置有向内延伸的盖凸缘1824，盖凸缘1824被定向成与在离合器套节部分1830上形成的向外延伸的离合器凸缘1834相互面对。第一摩擦垫1840以不可旋转的方式连接到向内延伸的盖凸缘1824。垫腔1836可在离合器凸缘1834中形成，以便将第二摩擦垫1850和波形弹簧1852可运动地容纳在垫腔中。第二摩擦垫1850可被设置有键条或键(未显示)，以防止第二摩擦垫1850在腔1836中旋转、但促进第二摩擦垫在腔1836内的一些轴向行进。在各种实施方式中，第一和第二摩擦垫1840、1850例如可由液晶聚合物、尼龙、聚碳酸酯、铝等制成。
在各种实施方式中，调节轴1650的近侧部分1652具有在其中形成的小节距螺纹段1654，该小节距螺纹段1654与较大节距螺纹段1657连接，见图79。如图81中可以看到的那样，驱动销1726向内突出到轴向通道1722中以便“驱动”接合调节轴1650中的螺纹段1654、1657。另外，调节轴1650的近端1652具有适于与位于近侧闭合螺母1740的锥形套节部分1746中的螺纹腔1748螺纹接合的螺纹部分1658。在各种实施方式中，驱动销1726在远侧闭合螺母1720中被定向成，当驱动销1726仍与调节轴1650的远侧小节距螺纹段1654接合时，使调节轴1650的螺纹端1658已经与近侧闭合螺母1740的锥形套节部分1746中的螺纹腔1748充分螺纹接合，以便当闭合调节器组件1800被旋转时在螺纹腔1748中螺旋行进。特别是，当闭合调节器组件1800沿着逆时针方向(“CC”)旋转时，调节轴1650借助驱动销1726与在连接杆1650中形成的螺纹段1654和1657接合而沿着远侧方向“DD”运动。本领域普通技术人员将会理解，与当驱动杆1726与具有比螺纹段1654更大节距的螺纹段1657接合时相比，当驱动销1726与远侧螺纹段1654接合时远侧闭合螺母1720的旋转将导致调节轴1650的更快的轴向运动。调节轴1650的轴向运动使顶部和底部张紧带1636、1638、套管针尖端1644和砧座1700(当与套管针尖端1644连接时)沿着远侧“DD”方向远离头部1610运动。
为了闭合砧座1700或者使其沿着近侧“PD”方向朝着头部1610和支撑在其中的钉仓1616运动，医生开始沿着顺时针方向(“CW”)转动闭合调节器组件1800。在第一和第二摩擦垫1840、1850之间产生的摩擦力用于保持闭合调节器组件1800与离合器套节1830摩擦接合，该离合器套节1830以不可旋转的方式连接到近侧闭合螺母1740。由于近侧闭合螺母1740以不可旋转的方式固定到远侧闭合螺母1720，远侧闭合螺母1720也沿着顺时针方向旋转。远侧闭合螺母1720的旋转导致驱动销1726与螺纹段1654、1657的任一个驱动接合(取决于相对于其的调节轴1650的位置)并引起调节轴1650沿着近侧方向(“PD”)被拉动。当调节轴1650沿着近侧方向被拉动时，调节轴1650的螺纹端1658与近侧闭合螺母1740的锥形螺纹套节部分1746的螺纹腔1748螺纹接合，并且直径减小部分1653运动到驱动销附近，使驱动销不再与调节轴1650驱动接合。现在，螺纹端1652与近侧闭合螺母1740中的螺纹孔1748完全螺纹接合。闭合调节器组件1800沿着顺时针方向的进一步旋转继续沿着近侧方向“PD”拉动调节轴1650。当调节轴1650沿着近侧方向被拉动时，砧座1700向着被支撑在钉驱动器组件1614中的仓1616运动以夹钳在砧座和仓之间的一定量组织。当砧座1700继续向着钉仓1616运动时，组织被压缩在二者之间并阻止砧座1700沿着近侧方向进一步行进。
在各种实施方式中，为了防止可导致损伤或者杀死被缝合组织的组织过度压缩，第一和第二摩擦垫1840、1850的组成和弹簧1852的尺寸被选择成，当达到预定的组织压缩量时，摩擦垫1840、1850开始滑动以防止闭合调节器组件1800的进一步旋转被传递到离合器套节1830。因此，即便医生在组织已经被充分压缩之后继续旋转闭合调节器组件1800，所述进一步旋转也将不会导致调节轴1650(和砧座1700)沿着近侧方向继续运动，从而避免过度压缩组织。例如，在各种实施方式中，器械可被构造成，可被施加到砧座1700与仓1616之间的组织的最大压缩力可以为大约每平方英寸150磅。对于这种应用来说，第一和第二摩擦垫1840、1850和波形弹簧1852可被如此构造成，如果闭合调节器组件1800在已经达到最大压缩力之后继续旋转，允许在第一和第二摩擦垫1840、1850之间的滑动。在所述例子中，闭合调节器组件1800的旋转可产生例如大约15英寸磅的扭矩大小，该扭矩克服当已经达到所需压缩的最大量(其用于保持第一和第二摩擦垫1840、1850彼此之间的摩擦接合)时在第一和第二摩擦垫之间形成的摩擦力并允许在第一和第二摩擦垫之间的所需滑动。在各种实施方式中，为了确保当闭合调节器组件1800沿着逆时针方向旋转时调节轴1650向远侧运动，一系列周向延伸的棘轮齿1816可在闭合调节器组件1800的内部形成以便与在离合器凸缘1834的圆周上形成的周向延伸的接合齿1835接合，见图83和84。齿1816、1835可被构造成，当闭合调节器组件1800沿着顺时针方向旋转以使砧座1700向着仓1616运动时，使闭合调节器组件1800上的齿1816滑过离合器凸缘1834上形成的齿1835。但是，当闭合调节器组件1800沿着逆时针方向旋转时，齿1816接合离合器凸缘1834上的齿1835以引起离合器套节1830以及近侧和远侧闭合螺母1720、1740与其一起旋转，使砧座1700运动离开仓1616。
如上所述，各种实施方式可被提供有保险轭1670，当保险轭1670处于“安全”或者接合位置时其防止扳机组件1664致动。在各种实施方式中，保险弹簧1686可以轴颈方式安装在调节轴1650上并被容纳在远侧闭合螺母1720的套节部分1724上。弹簧1686可被定位在远侧闭合螺母1720与保险释放器1684的直立端壁部分1688之间，参见图81。保险弹簧1686用于沿着远侧方向偏压保险释放器1684并使之与保险轭1670接触以防止保险轭被枢转到不工作位置，在该不工作位置，扳机1664可被致动。同样在这些变型中，杆夹具1690可通过延伸穿过位于杆夹具1690中的槽(未显示)的调节螺栓1692与调节轴1650连接。杆夹具1690可被定位在调节轴1650上，当调节轴1650已经沿轴向定位在其最近侧位置中(这导致最大量的所需压缩被施加到组织)时或者处于砧座1700已经开始夹钳组织但还没有达到预定的最大压缩力的位置中时，使杆夹具1690已经接触直立端壁1688并使直立端壁向近侧运动足够的距离，以使保险释放器1684的远端1685运动脱离与保险轭1670的保持接合。医生然后可将保险轭1670枢转到不工作位置，从而使扳机1664能够被压下。
本发明的各种实施方式还可配备有可通过枢轴销1678枢转安装在手柄组件1660内的钉成形指示器1676。钉成形指示器1676可具有能够通过在手柄组件1660中形成的视窗1663(图77)被观察的指示器端部1679。端部1679可由指示器弹簧1680沿着远侧方向偏压。如同在图79中看到的那样，钉成形指示器1676可被形成有被定位成通过保险释放器1684的钩形端1685接合的翼片1682。当保险释放器1684与调节轴1650的近侧运动有关地向近侧运动时，钩形端1685引起钉成形指示器1676沿着近侧方向枢转。指示器板(未显示)可被设置在窗1663内并且如此校准，使指示器1676与指示器板协作以指示砧座1700与仓1616之间的距离大小。
现在将参照图85-88描述使用圆形缝合器1600的一种示例性方法。当使用圆形缝合器进行吻合术时，肠1900可通过将多排钉安放在肠1900的目标部分(即样本)的任一侧上而使用常规外科缝合器进行缝合。图85示出了线性钉线1910、1920。当目标部分被缝合时该部分典型地被同时切割。在图85中目标部分已经被除去。接着，在除去目标样本之后，医生将砧座1700插入到肠1900的近侧部分1902中并位于钉线1910的近侧。这可通过将砧座头部1700插入到在近侧肠部分1902中切割形成的进口中来完成，或者砧座1700可通过将砧座1700设置在缝合器1600的远端上并通过直肠插入器械来经肛门放置。接着，医生可将砧座1700与缝合器1600的套管针尖端1644连接并将砧座1700插入到肠1900的远侧部分1906中。医生然后可使用缝线1912或者其他常规结扎装置将肠1900的近侧部分1902的远端1904系到砧座轴1704上，并且还使用另一缝线1914将远侧肠部分1906的近端1908系在砧座轴周围，见图86。医生然后开始沿着顺时针方向旋转闭合调节器组件1800以向着被支撑在钉驱动器1614中的仓1616拉动砧座1700，从而封闭砧座1700与仓1616之间的间隙并由此将二者之间的间隙“G”中的远侧肠部分1906的近端1908与近侧肠部分1902的远端1904接合，参见图87。医生继续旋转闭合调节器组件1800直到第一和第二摩擦垫1840、1850滑动并达到所需的压缩量(所需间隙G)。当处于该位置中时，医生然后可将保险轭1670枢转到不工作位置并通过压下击发扳机1664击发缝合器1600。压下扳机1664引起压缩轴1634向远侧驱动钉驱动器1614以驱动待驱动的钉1618穿过肠1900的两个端部1904、1908，从而将部分1902和1906连接并形成管状通道。同时，当钉1618被驱动并成形时，刀1620被驱动穿过肠组织端部1904、1908，切割与内排钉1618相邻的端部。医生然后从肠中退出缝合器1600，吻合完成。
图89-95示出了本发明的另一种缝合器实施方式1600a。除下面详细讨论的变化以外，缝合器1600a可基本上采用上面参照缝合器1600描述的相同元件。例如，在该实施方式中，可不采用滑动离合器组件。但是，该实施方式可采用闭合致动器组件2000，该闭合致动器组件2000包括可旋转地保持在一起的近侧盖部2010和远侧盖部2040。
更具体地说，如图90和91所示，在各种实施方式中，近侧盖部2010可具有套筒部分2012，其尺寸被设置成在远侧盖部2040的外壁部分2044上方延伸并通过在套筒部分2012上形成的向内延伸的凸缘2014保持在其上。凸缘2014可卡扣在远侧盖部2020的壁部2044的圆周上形成的向外突出的边沿2046上。所述设置用于将近侧盖部2010与远侧盖部2040连接同时便于其相对于远侧盖部旋转。为了易于连接，倾斜边缘2048可设置在壁部2044的端部2041上。
如同在图90和91中还可以看到的那样，远侧盖部2040可进一步具有盖套节部分2050，所述盖套节部分具有可旋转地容纳在形成于近侧盖部2010中的圆形槽2016中的近端2052。可相对于盖套节部分2050设计槽2016的尺寸，使近侧盖部2010可围绕盖套节部分2050自由旋转。另外，近侧盖部2010可具有可旋转地延伸到位于盖套节部分2050中的轴向通道2054内的突起2018，以给闭合调节器组件2000提供额外旋转支撑。从图90中可以看出，近侧闭合螺母1740的近端1741可形成有向近侧延伸的锥形套节部分1746，其适于以不可旋转的方式容纳在位于盖套节部分2050中的轴向通道2054中。锥形套节部分1746还可形成有键或者键条设置以便将套节部分1746以不可旋转的方式连接到盖套节部分2050。其他紧固件设置和方法也可被采用以便将近侧闭合螺母1740的套节部分1746以不可运动的方式连接到盖套节部分2050。因此，该套节部分2050的旋转将引起近侧闭合螺母1740和远侧闭合螺母1720也以上面描述的同样方式旋转，并根据近侧和远侧闭合螺母旋转的方向使调节轴1650向远侧或近侧轴向行进。
近侧和远侧闭合螺母1740、1720的旋转通过相对于远侧盖部2040旋转近侧盖部2010实现。近侧盖部2010和远侧盖部2040之间的相互作用可通过变力产生构件2060来控制，所述变力产生构件与那些元件相互连接并用于将与由在砧座1700与钉仓1616之间被压缩的组织受到的压缩量有关地将阻力施加到近侧盖部2010。在各种实施方式中，例如，变力产生构件可包括螺旋弹簧2060。在一些实施方式中，螺旋弹簧2060的最内侧端部2062可被构造成如图92所示并被插入到位于近侧盖部2010中的保持槽2020中。弹簧2060的端部2062还可通过其他紧固件设置与近侧盖部2010连接。同样地，弹簧2060的外侧端部2064可被构造成如图92中所示并被容纳在远侧盖部2040中形成的保持槽2045中。但是，弹簧2060的外侧端部2064可通过其他合适的紧固件设置与远侧盖部2040连接。
在各种实施方式中，参考指示器标记2070可设置在近侧盖部2010上，当缝合器1600a处于未行进或者中性位置时使参考指示器标记2070与位于远侧盖部2040的外壁2044上的相应初始标记2072对准，参见图89和95。当处于该对准位置时，螺旋弹簧2060可基本上无负载或者其可处于将近侧盖部2010保持在该开始位置中所需的较小的负载下。近侧盖部2010沿着顺时针“CW”方向的旋转可通过弹簧2060被传递到远侧盖部2040并传递到与远侧盖部2040连接的近侧闭合螺母1740上。近侧闭合螺母1740的旋转还引起远侧闭合螺母1720旋转并沿着近侧“PD”方向轴向拉动调节轴。当调节轴1650被向近侧拉动时，调节轴1650也引起砧座1700向着仓运动，因为其与通过如上面讨论的顶部和底部张紧带1636、1638与调节轴1650连接的套管针尖端1644连接。当砧座1700运动到更接近支撑在头部1610中的钉仓1616时，被夹钳在砧座和钉仓二者之间的组织1904、1908开始压缩并阻止砧座1700进一步行进到仓，参见图93。所述压缩阻力也必须被弹簧负载克服以便使砧座1700能够进一步压缩砧座1700与仓1616之间的组织1904、1908。
在各种实施方式中，达到组织压缩的最小量(“Min”)所需的弹簧负载大小(“L1”)可被确定，并且达到组织压缩的最大量(“Max”)所要求的弹簧负载大小(“L2”)也可被确定。另外，近侧盖部2010必须从中性位置旋转以产生弹簧负载L1的距离“D1”和近侧盖部2010必须旋转以产生弹簧负载“L2”的距离“D2”可被确定。图94中所示的图形示出了这些参数之间的关系的例子。本领域普通技术人员将会理解，所述关系可基于被使用的弹簧以及各种其他因素例如诸如装置的运动元件受到的摩擦力而变化。
从图95中可以看出，当近侧盖部2010已经旋转以产生最小压缩力“Min”时与近侧盖部2010的位置对应的第二指示器标记或者标识2080设置在远侧盖部2040的外壁2044上，使第二标识2080与近侧盖部2010上的参考指示器2070重合。同样地，第三指示器标记或者标识2082可设置在远侧盖部2040的外壁2044上，当近侧盖部2010已经被旋转到产生最大压缩力“Max”的位置时使第三标识2082与近侧盖部2010上的参考指示器2070重合，参见图95。本领域普通技术人员将会认识到，在不背离本发明的精神和范围的条件下，可采用各种不同标识设置。例如，在远侧盖部2040的外壁2044上的第二标识构件2080与第三标识构件2082之间的区域2084可被着色或者涂上绿色以指示医生参考指示器2070是否位于该区域中并且是否可达到可接受的压缩力大小。
因此，在这些实施方式中，弹簧2060提供了用于将由位于砧座1700与钉仓1616之间的组织受到的压缩量与近侧盖部2010必须旋转以达到该压缩量的距离相互关联的部件。所述设置允许使用近侧和远侧盖部2010、2040上的参考指示器和标识来使医生能够精确地确定何时砧座已经位于将导致可接受的钉成形的位置中。这些参考指示器和标识可被如此定向，以便当砧座已经运动到将导致最小压缩量被施加到组织上但仍有利于密封钉成形的位置时通知医生。同样地，所述参考指示器和标识可被如此定向，以便通知医生砧座已经运动到将导致最大压缩量被施加到组织上但仍有利于密封钉成形的位置。
尽管已经通过对多种实施方式的描述阐述了本发明，并且所示出的实施方式已经被非常详细地描述，但是，本申请人并不是想将所附权利要求限制或者以任何方式限定到如此的细节。对本领域技术人员而言，其它的优点和变型是可以想到的。例如，虽然为清楚起见已经示出了各种手动操作的外科器械，但应当理解，所述装置也可是机器人辅助操作的。此外，本领域技术人员将会理解，在这里公开的实施方式、特征和改进可以很容易与其他已知的在开放式、腹腔镜、内窥镜和/或经腔外科手术中应用的外科切割/缝合器、缝合器等结合使用。特别是，所述独特新颖的特征可与线性缝合器、切割器、周线切割器等结合使用。因此，对于在这里公开的各种实施方式的范围和保护不应当仅仅被限制为内切割器型外科缝合器。
尽管已经对本发明的多种实施方式进行了描述，但显而易见的是，本领域技术人员可对各种实施方式进行各种变化、改变和修改以获得本发明的部分或全部优点。例如，根据各种实施方式，单个元件可被多个元件替代，并且多个元件可被单个元件替代以实现给定的一个或多个功能。因此，在不背离由所附权利要求书限定的本发明的范围和精神的条件下，本申请也覆盖所有所述变化、改变和修改。
在本文中公开的装置可被设置成在单次使用后被处理，或者它们可被设计成多次使用。但是，在任一情况下，装置在至少一次使用后可被再生以便重新使用。再生可包括装置的拆卸、接着清洁或替换特定部件以及随后重新组装的步骤的任一组合。特别是，装置可被拆卸，并且装置的任意数目的特定部件或部分可选择性地以任何组合被替换或者除去。当清洗和/或替换特定部分时，装置可在再生工厂或者由手术团队在外科手术前立即被重新组装以便随后的使用。本领域技术人员将会理解，装置的再生可利用用于拆卸、清洗/替换以及重新组装的各种技术。所述技术的使用以及获取的再生装置都落入本发明的范围内。
优选地，在本文中公开的本发明将在外科手术前被处理。首先，获取新的或者使用过的器械并在需要的情况下对其进行清洁，该器械然后可被灭菌。在一种灭菌技术中，容器和器械被放置在闭合并密封的容器中，诸如塑料袋或袋中。容器和器械然后被放置在可穿透容器的辐射场中，诸如γ射线、x射线或者高能电子。辐射杀死器械上以及容器中的细菌。灭菌的器械然后可被储存在灭菌容器中。密封的容器保持器械处于灭菌状态，直到其在医学场合下被打开。
在本文中使用的术语“流体连接”指的是元件与合适的管线或者其他部件连接在一起以允许加压气体从其中通过。在本文中的术语“管线”、“供应管线”或者“返回管线”指的是由刚性或者柔性导管、管、管材等形成的合适通道，用于从一个元件将流体输送到另一元件。
声称通过引用结合在本申请的任何专利、出版物或者其它公开材料，全部或部分，仅仅包含到所包含的材料不与现有定义、表述或者在该公开文本中阐明的其它公开材料相冲突的程度。这样，并到必要的程度，在本文中明确阐明的公开内容取代任何通过引用包含在本文中的相冲突的材料。声称通过引用包含在本申请中但与现有定义、表述或者其它公开材料相冲突的任何材料或者其部分仅仅被包含到不引起包含的材料与现有公开材料之间的冲突的程度。
旨在受到保护的本发明不应被解释为被限制为所公开的特定实施方式。因此实施方式被认为是解释性的而非限制性的。在不背离本发明的精神的条件下可由其他人进行变化和改变。因此，明确表示在如在权利要求书中限定的本发明的精神和范围内的所有等同物、变化和改变都由此而被包括。
如同在本领域公知的那样，外科钉可被用于在例如组织已经被切割之后将多层组织保持在一起。常常，如上面描述的那样，外科缝合器被用于使钉从未施放形状变形成施放形状、即变形形状。参见图27，钉(诸如钉83)例如包括基部或钉冠和从基部或钉冠延伸出的可变形腿部。在使用时，可变形腿部典型地由外科缝合器中的砧座向着钉冠变形。参见图27，该变形的程度常常取决于正被缝合组织的厚度。更具体地说，如果组织较薄，在砧座接触组织之前使砧座更加靠近钉仓，结果在钉抵靠砧座变形之前钉将具有更小的施放距离。例如，图27中左侧的钉的腿部穿过较薄的组织插入，而右侧的钉的腿部穿过较厚的组织插入，结果，左侧的钉的腿部变形得比右侧的钉的腿部更多。作为前述的结果，同一钉设计可以很容易适应具有不同厚度的各种组织。
如上所述并参见图27，钉83的腿部向着钉的基部或者钉冠弯曲。更具体地说，腿部的端部由缝合器的砧座卷曲直到达到所需的变形。换一种方式来说，当腿部的端部接触缝合器的砧座时，端部由砧座导引，使腿部连续弯曲成弓形构型，直到钉被变形成例如“B”字形状。在钉具有长腿部的实施方式和/或在钉被用于非常薄的组织的实施方式中，腿部可以相当大的程度被卷曲，使它们的端部从钉向外突出。在这些实施方式中，端部可以是锋利的并可撞击在周围的组织上，引起患者不适。为了改进该问题，与上面描述的连续的弓形形状不同，本发明包括可分段弯曲的钉1300。
与上面类似的并参见图96，钉1300包括钉冠1302和从钉冠1302延伸出的可变形腿部1304和1306。腿部1302、1304包括位于其中的第一切口1310、第二切口1312和第三切口1313。在使用时，参见图105，当腿部1304和1306的端部1308接触砧座1316的凹窝1314时，端部1308例如可彼此相向被导引。当钉由滑动件式驱动器78进一步向着砧座1316驱动时，参照钉1300b，腿部1304和1306可在第一切口1310处以相当大的程度弯曲。参见图97，由于腿部1304和1306在第一切口1310处的减小的横截面，腿部1304和1306在切口1310的位置处更容易变形。例如，当腿部1304和1306在切口1310处弯曲时，第一段1318例如可以相对于腿部1304和1306的第二段1320以大约90度的角度弯曲。在其他实施方式中，第一段1318可相对于第二段1320以任何合适的角度弯曲。
此外，参见图98，腿部1304和1306的第二切口1312允许第二段1320例如以大约90度的角度相对于第三段1322弯曲。在其他实施方式中，第二段1320可相对于第三段1322以任何合适的角度弯曲。与上面类似，切口1313允许第三段1322相对于第四段1325弯曲。由于切口1310、1312和1313，腿部1304和1306不能如上所述地弯曲成连续卷曲，而是它们被弯曲成分段的矩形构型。由于上述原因，具有长腿部1304、1306的钉可以被变形，使得可变形构件的端部不从钉向外延伸，而是如图99中所示它们可被定位在腿部1304和1306中间。虽然在图96-105中示出的钉的腿部具有三个切口和四个段，可以设想具有附加或者更少的切口和段的各种实施方式。此外，虽然上面描述的钉的腿部的段大体上是直的，但可以设想其中段为弧形的、曲线形的或者其他合适构造以实现所需形状的各种实施方式。
为了便于第三段1322相对于第四段1325弯曲，例如，钉冠1302可包括成形表面或者砧座，以便当它们接触钉冠1302时导引和/或变形腿部1304和1306。更具体地说，参见图99和101-104，当腿部1304和1306从图98中所示的形状被变形到图99中所示的形状时，可变形构件1304和1306的端部1308可接触钉冠1302。为了导引端部1308，钉冠1302的砧座1323包括凹槽1324，凹槽1324可引导端部1308以如图99中示出的向外运动或者沿着任何其他合适方向运动。在各种实施方式中，凹槽1324可不使腿部1304和1306明显变形，但是在图示的实施方式中，凹槽1324被构造成使腿部1304和1306以大约90度的角度变形。在各种实施方式中，缝合器的砧座1316和钉冠1302中的砧座1323能够相互协作使钉1300变形成例如图99中所示的形状或者任何其他合适形状。
在各种实施方式中，虽然没有示出，作为钉冠1302中的砧座1323的附加或者作为其替代，成形表面或者砧座可被包括在钉仓1326中。在这些实施方式中，砧座1316使腿部1304和1306变形，使端部1308接触缝合器仓1326中的凹槽。与上面类似，钉仓凹槽可被构造成当腿部1304和1306接触缝合器仓1326时导引和/或变形腿部1304和1306。在各种实施方式中，钉冠1302和缝合器仓1326两者上的砧座可被用于变形和/或导引钉。在图示的实施方式中，钉冠1302包括包覆模制到基部1301上的材料1303。如同在下面详细讨论的那样，材料1303可包括塑性材料，例如可生物吸收材料，和/或生物不可吸收材料。在这些实施方式的至少一种中，材料1303围绕构成基部1301和可变形构件1304和1306的单个连续丝形成。在其他实施方式中，可变形构件1304和1306可包括嵌入到塑性材料1303中的独立可变形构件。此外，在各种实施方式中，构成基座1301的丝可被变形以提供上面描述的凹槽和砧座。
参见图106和107，与上面类似，在各种实施方式中，钉可包括钉腿部中的多个颈缩部分，颈缩部分可被构造成引起腿部在颈缩部分处变形和/或弯曲。更具体地说，钉1340可包括允许钉腿部1344以上面描述的分段方式变形的多个颈缩部分或者锥形部分1342。与切口1310、1312和1313类似，锥形部分1342提供了应力集中区域。应力集中区域通常是被加载构件例如将会被破坏的位置。换言之，应力集中区域可放大在被加载构件的特定区域中的应力，从而导致在被加载构件的其余部分塑性应变之前使被加载构件在应力集中区域处屈服或者塑性应变。在本文中，术语“屈服”一般指的是最大应力和/或应变的点，超过该点材料将不再以完全弹性的方式起作用。但是，可以设想，在本文中使用的材料例如不具有传统屈服点的各种实施方式。这些材料可包括当它们被施加应力时立即塑性应变的材料、和/或不具有可识别的屈服点的超弹性材料。这些材料可包括形状记忆合金，诸如Nitinol，例如允许在上面描述的成形过程中较大的应变变形。典型地，工程师们被指示消除应力集中区域以实现所需目标；但是，根据本发明的教导，应力集中区域可被用于实现上面描述的目标。
在各种实施方式中，参见图108-110，钉1329包括基部1331和从基部延伸的两个可变形腿部1333。腿部1333每个可包括具有大体上为圆形横截面的第一部分1335和具有大体上扁平横截面的第二部分1337。在至少一种实施方式中，腿部1333和基部1331由金属丝构成，金属丝的端部被冲压或成形，以产生大体上平坦部分1337。如在本领域已知的那样，冲压或成形金属丝可采用在金属丝被弯曲成图108中所示的“U”形之前和/或之后进行冲压而预成形。参见图110，腿部1333被构造成使平坦部分1337可被弯曲以将组织固定在钉内同时圆形部分1335可保持基本上不被弯曲。结果，在使用时，钉1329可被用于固定较厚的组织。更具体地说，由于存在基本上不弯曲的部分1335，较厚的组织可被容纳在部分1335之间同时平坦部分1337可被弯曲以将组织保持在它们之间。其中平坦部分1337被变形的量典型地取决于被捕获在钉中的组织的厚度。
在各种实施方式中，参见图111，钉1441可包括具有锥形构造的可变形腿部1443。更具体地说，钉腿部1443可包括基部1444，该基部1444的横截面比尖部1445的横截面大。在使用时，与上面类似，钉可适用于较厚的组织，因为由于基部1444的较大的横截面，基部1444可大体上保持不弯曲同时尖部1445被弯曲以保持钉中的组织。在其他各种实施方式中，参见图112，钉1446可包括多个阶梯部分1447和1448，它们允许腿部1449的一些部分弯曲，一些部分仅仅被部分弯曲，另一些部分基本上保持不弯曲。阶梯部分的合适量和构造可被选择成适应于被固定的组织的类型和/或厚度。
参见图113和114，与钉1340类似，钉1350包括钉冠1302和可变形腿部1344。如上所述，在至少一种实施方式中，钉1340被构造成压缩可变形腿部1344与钉冠1302之间的组织。但是，例如在其中组织非常薄的应用中，可变形腿部1344与钉冠1302之间的组织的充分压缩可能是难以实现的，例如组织与腿部1344之间可能存在间隙。对于这些应用，可能需要在组织与可变形构件和/或钉冠中间包括附加构件，该附加构件不仅填充间隙，而且将组织压靠到钉冠和/或可变形构件的至少一个上。
参见图113和114，在各种实施方式中，钉1350可包括可变形或者可压缩构件1352。如上所示，参见图114，可压缩构件1352可将组织1353偏压到可变形腿部1344上。由于这种压缩的结果，组织1353中的腔或者血管可被压缩并由此减缓流经其中的血流。在至少一种实施方式中，可压缩构件1352完全是弹性的，在其已经被压缩后，即任何在可压缩构件1352上的应力增加或应力去除将导致可压缩构件1352的应力的相应线性增加或减少。换言之，在这些弹性实施方式中，可压缩构件1352可大体上起到类似于弹簧的作用。但是，在至少一种实施方式中，可压缩构件1352可以是可压碎的，即在其已经被压缩之后，至少一部分(如果不是全部)可压缩构件1352被永久变形，并且可压缩构件1352上任何应力的增加或去除都不需要导致相应线性应力。在各种实施方式中，可压缩构件1352可由泡沫构成。泡沫可以是可吸收的或者不可吸收的。泡沫可包括合成材料和/或来自哺乳动物的材料，包括但不限于：聚乙交脂三亚甲基碳酸酯共聚物、聚羟基乙酸、乙内酯/乙交脂、EPTFE和牛心包膜。此外，在至少一种实施方式中，可压缩构件1352可包括可弹性变形的第一部分和可塑性变形的第二部分。
参见图115和116，钉1360可包括可伸缩弹簧构件1362。可伸缩弹簧构件1362可包括多个第一弹性构件1363和多个第二弹性构件1364。每个第一弹性构件1363可包括弓形轮廓，弓形轮廓包括从其延伸的突起1365，并且突起1365的尺寸和构造被设置成与从每个第二弹性构件1364延伸的相应突起1366接触。更具体地说，第一弹性构件1363和第二弹性构件1364被构造成它们可彼此堆叠，当压缩负载被施加到所述堆叠上时，第一和第二弹性构件可变平并由此“收缩”弹性构件的堆叠。在图示的实施方式中，可伸缩弹簧构件1362进一步包括紧固件1367和1368。参见图115，紧固件1367可将相邻第一弹性构件1363和第二弹性构件1364的中间部分连接起来，以防止弹性构件被移动或者相对于彼此错配。类似地，紧固件1368可防止可伸缩弹簧构件1362相对于钉冠1302移动。在使用时，可伸缩弹簧构件1362可将压缩负载提供到所述可变形构件与所述钉冠之间的组织上。
参见图117和118，钉1370可包括悬臂弹簧1372。悬臂弹簧1372包括与钉冠1302连接的第一端部1373和相对于第一端部1373自由运动的第二端部1374。在使用时，当组织被压缩在弹簧1372与可变形腿部1344之间时，弹簧1372可对组织施加向上的偏压或压缩力。更具体地说，当可变形腿部1344被变形并被推靠到组织上时，弹簧1372的第二端部1374可相对于第一端部1373向下运动。这种偏转的结果是，弹簧构件1372储存势能并通过对组织施加向上的力动作以释放这种势能，由此压缩弹簧构件1372与可变形腿部1344之间的组织。在替代实施方式中，参见图119-121，钉1380的弹簧构件1382可具有分别与钉冠1302连接的第一端部1383和第二端部1384。在至少一种实施方式中，例如，弹簧1372和1382可与钉冠1302一体模制成。在这些实施方式中，弹簧1372和1382可包括可溶解、可生物吸收或者可生物降解材料，随着材料被溶解时，可使弹簧1372和1382的偏压力在整个愈合过程中降低。结果，在开始愈合阶段过程中当血液损失的限制很重要时可施加较大的压缩力，在后期愈合阶段过程中当组织再生很重要时施加较小的压缩力，其中较小的力允许组织在钉内的膨胀和生长。
在其他实施方式中，虽然没有示出，组织可被定位并压缩在钉的可压缩构件与钉冠之间。在这些实施方式中，可变形构件抵靠可压缩构件变形，结果，可压缩构件被压缩在可变形腿部与组织之间。
参见图122和123，钉1400包括钉冠1402，第一可变形构件1404和第二可变形构件1406。可变形构件1404和1406每个都包括基部1408、可变形腿部1410和第二腿部1412，在图示的实施方式中它们由单个连续的金属丝构成。在其他各种实施方式中，钉1400可以任何其他合适的方式被构造以实现在本文中描述的发明的目标。在图示的实施方式中，构件1404和1406通过被包覆模制在构件1404和1406的基部1408上的材料连接在一起。在各种实施方式中，所述材料可包括可溶解、可生物吸收或者可生物降解材料，诸如例如来自Ethicon，Inc的Vicryl和PDS。在本文中，术语可溶解、可生物吸收和可生物降解一般指的是例如在被植入到患者体内之后至少可部分被身体吸收的材料。
在使用时，钉1400可例如借助缝合器被插入到人的软组织中，并可被变形成图124中所示的构造。更具体地说，可变形构件1404和1406可由缝合器的砧座变形，使腿部1410的端部1411与钉冠1402紧密靠近。一旦钉1400被植入到组织中，钉冠1402可开始瓦解、溶解和弱化。更具体地说，参见图125，钉冠1402的可生物吸收材料正好破坏到其中第一构件1404和第二可变形构件1406开始彼此脱离连接，如图126所示。一旦第一构件1404和第二构件1406已经脱离，它们可相对于彼此运动。钉冠1402充分溶解所需的时间可取决于钉冠1402使用的材料和/或尺寸。例如市售商标名为Vicryl的Polyglatin 910材料可在7-14天内溶解。
在各种实施方式中，可溶解钉冠1402可提供多种治疗优点。例如，当钉1400被初始放置时，可变形构件1404和1406可抵靠钉冠1402显著压缩钉内的组织。在一些应用中，这种压缩可能是需要的以限制组织出血。当钉冠1402破坏时，变形构件1404和1406与钉冠1402之间的间隙会增加，从而缓解作用于组织上的压缩力。在一些应用中，在愈合过程中缓解压缩力可允许组织在一段时间内缓慢膨胀并恢复到其正常厚度。在一些实施方式中，钉冠1402可涂敷有亲水材料，其在溶解离开组织之前初始膨胀以压缩被捕获在钉内的组织。在这些实施方式中，亲水材料通过从周围组织和流体中吸收水分而膨胀。除上述以外，当钉1400被插入到组织中时，其可以非常硬，并且如果多个钉被插入到组织中时，在愈合过程中组织可不允许运动和膨胀。但是，在钉1400的钉冠1402已经溶解之后，钉的可变形构件1404和1406能够相对于彼此运动，同时仍将下面的组织保持在一起。
在各种实施方式中，可变形构件1404和1406可包括大体上不溶解或者生物不可吸收的材料。在其他实施方式中，至少一个可变形构件1404和1406可包括可溶解、可生物吸收或者可生物分解材料例如诸如镁或者铁。在至少一种实施方式中，铁为纯铁。在任一种情况下，构件1404和1406的可溶解材料可被选择成使它们以与钉冠1402的可溶解材料相同、更慢或更快的速度溶解。例如，钉冠1402的材料可被选择成，在可变形构件1404和1406仍将组织保持在一起时使钉冠完全溶解掉。此外，在各种实施方式中，第一可变形构件1404的材料可被选择成使其比第二可变形构件1406溶解得更快。因此，这些实施方式的可变形构件可允许组织交错释放。此外，在各种实施方式中，如下面详细描述的那样，至少两个相邻的钉1400可在钉已经被放置到组织中之前和/或之后通过桥接件连接。在这些实施方式中，第一钉可包括可生物吸收材料，其以比与其连接的第二钉的材料更快的速度溶解掉。类似地，连接钉的桥接件可包括以与第一钉和第二钉相同和/或不同的速度溶解掉的材料。在这些实施方式中，第一钉可在第二钉之前溶解掉，允许组织的交错释放。
上面描述的钉可被用于使组织靠近，即钉可固定被切除或者损伤的组织，使被切除或损伤的组织的强度与健康组织的强度接近。为此，使组织靠近的方法可包括：使用包括可溶解材料和不可溶解材料的外科钉缝合组织以便使组织以第一状态靠近；溶解可溶解材料以使剩余不可溶解材料使组织以第二状态靠近。在至少一种实施方式中，在第二状态中的组织靠近比第一状态下更具柔性。
除了上面描述的以外，参见图132，钉冠1402可包括至少两个包覆模制或者共同模制的材料。更具体地说，钉冠1402例如可包括包覆模制在可变形构件1404和1406上的第一材料1435和包覆模制在第一材料1435上的第二材料1436。在该实施方式中，第二材料1436可被构造成迅速溶解，从而允许可变形构件1404和1406在愈合过程中的早期就彼此分离。但是，第一材料1435可被选择成以比第二材料1436更慢的速度溶解以便使钉冠1302即便在第二材料1436已经完全溶解的情况下继续提供在组织上的压缩力。在至少一种实施方式中，第一材料1435可被注模到可变形构件1404和1406上，然后在第二材料1436注模到第一材料1435上之前允许其干燥(cure)和/或完全固化。在其他实施方式中，第一材料1435和第二材料1436可在大体相同的时间或者迅速连续注模到可变形构件1404和1406上。在这些实施方式中，第一和第二材料可以化学方式结合到一起以提供二者之间的足够强度，使钉可被处理而不需要将第一和第二材料彼此分离。在其他实施方式中，第一和第二材料可形成机械互锁部件以实现相同的结果。
在图123中所示的实施方式中，钉冠1402可包括位于部分1416和1418中间的横截面减小部分1414。在使用时，由于中间部分1414的横截面比部分1416和1418的横截面小时，其可在部分1416和1418之前完全溶解，从而允许在整个钉冠1402已经溶解之前第一构件1404与第二构件1406脱离连接(图125)。在至少一种实施方式中，部分1414、1416和1418的横截面可被选择成使可变形构件1404和1406在愈合过程中的所需阶段脱离连接。在至少一种实施方式中，参见图133，钉冠1402可包括刻痕标记1437，所述刻痕标记减小了钉冠1402在刻痕区域的厚度。在这些实施方式中，刻痕标记可在钉冠1402包覆模制到可变形构件1404和1406上时形成，或者在包覆模制之后由切割工具形成。由于刻痕标记1437，当钉冠1402溶解时，其断裂形成多个小片，在一些情况下，这些小片更容易被身体吸收。在至少一种实施方式中，参见图134，钉冠1402可包括在突出部分1439中间的多个凹窝1438。在使用时，材料中间突出的部分1439可溶解，留下在可变形构件1404和1406中间的突出部分1439的格子或者栅格。
在至少一种实施方式中，钉冠1402还包括至少一种治疗药物。在这些实施方式中，当可溶解材料破坏时，治疗药物可被周围组织吸收。在一些实施方式中，药物被分散到整个可溶解材料中，使药物在愈合过程中被稳定释放，但是，在其他实施方式中，治疗药物可在整个可溶解材料中不均匀地分散，或者夹层在材料内和/或上以在愈合过程中的特定阶段提供增加的药物剂量。
在至少一种实施方式中，带可吸收绝缘体的可吸收钉降低了例如当电灼烧装置在该位置使用时沿着钉排形成电弧的可能性。由于每个钉的顶部在正常操作条件下不导电，钉上的可吸收绝缘体或者钉冠基本上防止了电流在钉之间跳跃。结果，损伤组织的可能性被降低。
在使用时，如上所述并参照图127和128，钉1400的可变形构件1404和1406由缝合器1422的砧座1420变形。更具体地说，构件1404和1406的端部1411被容纳在砧座1420中的凹槽1424中，并且当构件1404和1406由砧座1420变形时向着钉冠1402被导引。参见图129和129A，凹槽1424可包括引起构件1404和1406的端部弯曲离开构件1412和基部1408的平面的构造。更具体地说，参见图130和131，每个凹槽1424包括多个平面，这些平面被定向成侧向然后向下的初始偏转端部1411，以使可变形腿部1410的顶部沿着可变形腿部1410的底部卷曲，如图131所示。参见图130和131，凹槽1424包括表面1426和1428，在二者之间形成顶点1430。表面1426、1428和顶点1430被构造成例如容纳可变形构件1406的端部1411。在由砧座1420施加足够的压强之后，可变形构件1406的腿部1410在顶点1430内卷曲。此后，随着腿部1410进一步变形，腿部1410还接触凹槽1424的表面1428和1434中间的顶点1432。如图131所示，顶点1432辅助将构件1406变形成所需形状。虽然上面结合钉1400描述砧座，但这些砧座可被用于变形其他不同构造的钉，包括在本申请中公开的合适的钉。
参见图96和97，钉1300包括一体成形钉冠和驱动器。更具体地说，参见图105，钉冠1302被构造成由凸轮滑动件78直接驱动。在使用时，如同将在下面详细描述的那样，凸轮滑动件78穿过钉仓从图105所示的位置向着钉仓1326的远端1327逐渐行进。当凸轮滑动件78沿着该方向运动时，钉1300由凸轮滑动件78向着砧座1316连续升高。在现有外科缝合器中，独立驱动器被定位在凸轮滑动件与钉中间。但是，本发明通过包括在钉冠1302中的特征件允许钉1300由凸轮滑动件78直接升高而简化了这些现有系统。更具体地说，参见图96和97，钉冠1302包括倾斜表面1328，其被构造成与凸轮滑动件78的倾斜表面1330协作，使钉冠1302在凸轮表面1330上滑动。在图示的实施方式中，倾斜表面1328和凸轮表面1330都被定向为与水平方向成大约30度角。结果，在本实施方式中，倾斜表面1328可与凸轮表面1330齐平地置于该凸轮表面1330上，但是，可以设想倾斜表面1328和凸轮表面1330不以相同角度定向的实施方式。此外，本发明不限于具有30度角的实施方式。相反，一个或多个任何合适的角度都可被使用。
参见图96和97，在图示的实施方式中，钉1300的基部1301被嵌入钉冠1302中。更具体地说，钉冠1302可被包覆模制到基部1301上，使钉冠1302紧紧围绕基部1301，其中在本实施方式中，基部1301由钉冠1302包封或围绕。在其他各种实施方式中，钉冠1302可单独被制造然后与基部1301组装。在任一情况下，基部1301和/或可变形构件1304和1306可至少部分地嵌入钉冠-驱动器1302中。结果，钉1300可包括比现有设计更大的可变形构件1304和1306。在这些实施方式中，由于上述原因，钉1300可在可变形构件与钉冠1302的组织接触表面1336中间容纳更多的组织。在一种实施方式中，钉冠-驱动器1302可包括可溶解或者可生物吸收材料，如上所述，当钉冠-驱动器1302溶解时，允许被压缩在钉1300中的组织膨胀和生长。在各种实施方式中，如上所述，钉冠-驱动器1302可包括或者涂敷有亲水材料，当暴露于体内的水分时其膨胀以进一步压缩钉中的组织。此外，与上面类似，钉冠-驱动器1302可被构造成增加钉冠1302与组织之间的接触面积。在一些实施方式中，增大该接触面积减小了组织表面上的局部应力，这可例如降低组织坏死的可能性。
如上所述，一体化钉冠和驱动器可减少放置钉所需要的元件的数量。结果，根据本发明的实施方式可降低生产缝合系统的成本和/或缩短制造时间。此外，没有独立驱动器元件可降低钉与凸轮滑动件之间错配的可能性。
在本发明的替代实施方式，参见图135，钉1450的每个均可包括钉冠1451和从该钉冠1451延伸的可变形腿部1452。参见图135，钉1450的钉冠可通过桥接件1455连接在一起。与上面类似，钉冠1451和桥接件1455可一体模制到钉腿1452上。还与上面类似的是，钉冠1451可包括倾斜表面1453，参见图139，倾斜表面可被构造成与凸轮驱动器1462的倾斜表面1454协作。如上所述，凸轮驱动器1462被构造成向着定位在钉仓1457的相对仓板1456上的砧座连续升高钉1450。如同将在下面更详细讨论的那样，即便在钉1450已经被放置之后，桥接件1455也可被构造成连接钉1450，或者作为替代，钉仓1457可包括使桥接件1455断开并且当钉1450被放置时分开钉1450的剪切部。
参见图136-138，钉仓1457进一步包括被构造成容纳钉1450的腔1458。在至少一种实施方式中，腔1458包括其尺寸和构造设置成配合在钉冠1451中的槽1460的键1459。更具体地说，在本实施方式中，槽1460和键1459被构造成大体上将钉1450相对于钉仓1457的运动限制成基本上为线性的运动，即在本实施方式中为向上和/或向下的运动。由于这些部件，钉1450被束缚在腔1458内或者相对于腔1458错配的可能性被降低。在替代实施方式中，腔1458可包括槽并且钉1450可具有键。
虽然表面1453在这里已经被描述为倾斜的，但表面1453不限于平坦表面。相反，可以设想表面1453为弧形、圆角形、曲线形和/或包括具有各种结构的多个部分的各种实施方式。在任何一种情况下，表面1453被构造成与凸轮滑动件1462协作，使钉1450如上面所述那样被放置。类似地，凸轮滑动件1462的表面1454不被限制为平坦表面。相反，表面1454可为弧形、圆角形、曲线形，和/或具有任何其他合适构造。
参见图140，钉仓1500包括用于容纳钉带1504的凹槽1502。参见图140和141，钉带1504包括由桥接件1508连接在一起的多个钉1506。凹槽1502包括多个凹窝1510，凹窝1510的尺寸和构造被设置成用于将钉1506容纳在凹窝1510中。在至少一种实施方式中，钉1506包括可变形构件1512，其尺寸和构造被设置成能够被压靠到凹槽1502的切口1514的侧壁上。更具体地说，可变形构件1512可被构造成在钉1506和凹窝1510之间建立压配合，使钉带1504在正常使用状态下保持安放在凹槽1502中。但是，在本实施方式中，钉带1504可被施加的适中的力从凹槽1502中除去。
如图140所示，凹槽1502开放到钉仓1500的顶面1516，使钉带1504可通过将带1504与顶面1516中的凹槽1502对准并将它们压进图141中示出的位置中而被插入到钉仓1500中。参见图141，凹槽1502进一步包括位于相邻凹窝1510中间的凹陷部分1518，凹陷部分1518的尺寸和构造被设置成容纳桥接件1508。在图140-143所示的实施方式中，桥接件1508被构造成当钉1506被插入到凹窝1510中时使相邻钉1506可相对于彼此运动。因此，桥接件1508可适应在带1504与凹槽1502对准时的尺寸差别和/或制造误差。更具体地说，每个桥接件1508可包括被构造成允许桥接件1508的部分1522相对于彼此运动的弧形部分1520。
在图示的实施方式中，每个钉1506的可变形构件包括可被弯曲成“U”和/或“V”形的单根连续丝。在本实施方式中，钉冠1513可被包覆模制到这些丝的一部分上，使丝被嵌入钉冠1513中并由钉冠1513支撑。另外，如图143所示，当钉冠1513被包覆模制在丝上时桥接件1508可与钉冠1513一体模制成。结果，在本实施方式中，桥接件1508和钉冠1513例如可包括一体的连续塑料主体。虽然没有示出，但在各种实施方式中，桥接件1508和钉冠1513可被模制成可与钉连接的一个或多个独立元件。在这些实施方式中，钉的丝例如可以压配合和/或胶粘到单独模制的元件中的凹槽中。
在使用时，参见图144，当滑动件78向前运动时，滑动件78朝着定位在相对的顶面1516上的砧座向上升高钉1506。由于滑动件78的表面1523的倾斜朝向，例如，钉1506a-1506e以连续顺序逐渐升高。更具体地说，在钉1506a和1506b由滑动件78升高的同时，钉1506a和1506b可在任何给定时刻被升高到相对于表面1516的不同相对高度。为了适应在相对位置处的这种不同，桥接件1508a可以是柔性的，当钉1506a正被放置时该桥接件1508a不会断裂。在图144中的实施方式中，桥接件1508a可被构造成在钉1506a和1506b放置过程中以及此外在患者开始愈合过程中使桥接件1508a保持与钉1506a和1506b的连接。
在其他不同实施方式中，参见图145-147，钉1506可由桥接件1526连接在一起形成钉带1528。与桥接件1508类似，当钉冠1513如上所述被包覆模制到可变形构件1512上时桥接件1526可与钉冠1513一体形成。但是，与桥接件1508不同，桥接件1526可被构造成使它们从与它们连接的两个相邻钉1506中的至少一个上断开。更具体地，参见图146和147，桥接件1526中可包括切口1530，切口1530被构造成减小桥接件1526的横截面厚度和强度。在使用时，参见图147，当钉1506a相对于钉1506b被向上升高时，桥接件1526a可从钉1506a上断开。换言之，当钉1506a被向上升高时，通过拉动钉1506a离开钉1506b在桥接件1526a中形成的应力可引起桥接件1526a断裂，特别是在桥接件1526a的具有切口1530的部分中。
在图示的实施方式中，桥接件1526a可在钉1506b已经被放置之后保持与钉1506b的连接。在其他实施方式中，桥接件1526a可保持与钉1506a连接。在任何情况下，切口1530可被设置成使桥接件1526保持与所需钉的连接。在其他实施方式中，桥接件1526可与两个相邻的钉1506分离并且落入钉仓1500和/或滑动件78内的腔(未显示)中。在这些实施方式中，分离的桥接件1526可通过除去钉仓、和/或经过在钉仓和/或滑动件任意之一中的检修孔盖板除去它们而从缝合器中被除去。在各种实施方式中，切口1530没有被包括在每个桥接件1526中。在这些实施方式中，多个钉可在被放置之后保持彼此连接而其他钉可被分离。在这些实施方式中，当插入到组织中时钉排的硬度可通过钉被连接还是分离的选择性交替来控制。
参见图146，桥接件1526可包括大体上为平坦的顶面1532，其基本上与钉冠1513的顶面齐平。桥接件1526可进一步包括在桥接件1526的底部中的大体上为弓形的表面或者凸形部(lobe)1534，使桥接件1526的最厚部分与钉1506相邻。由于这种构造，钉带1528的整体偏转可被降低，使钉带1528更容易插入到钉仓中。在其他实施方式中，参见图148-150，桥接件1536可具有朝上、即与面向桥接件1526的相反方向的凸形部1534。作为具有平坦表面1532的桥接件1526和1536的结构的替代，桥接件可包括在桥接件两侧上的弓形构造。在这些实施方式中，与图142和143中的实施方式类似，桥接件可偏转以允许在相邻钉1506之间的一些相对运动。
在各种其他实施方式中，参见图151-157，钉带可从钉仓的底部被加载到钉仓中。例如，参见图155-157，钉仓1550包括其尺寸和构造分别被设置成用于容纳钉带1540和1542的腔1552和1554。在使用时，钉带1540和1542分别与底面1551中的开口1555和1557对准并被插入到腔1552和1554中。在各种实施方式中，钉带1540和1542可被构造成使它们被压配合到腔1552和1554中。在这些实施方式中，与上面类似，可变形构件1512可与腔的侧壁接合以将钉带1540和1542保持在钉仓1550中。在各种实施方式中，钉带1540和1542的钉冠1513和/或桥接件1538的尺寸可被设置成使它们以摩擦配合的方式与腔1552和1554的侧壁接合。在其他实施方式中，钉仓1550和钉带1540和1542可包括协作的止动部件，止动部件将钉带保持在钉仓中。一旦被插入到腔中，钉带1540和1542的钉1541可被定位成使它们的可变形构件1512的一部分延伸穿过顶面1553中的开口1559和1561。如图151所示，钉1541的可变形构件1512可从钉冠1513大体上垂直延伸。
与上面类似，参见图155和156，钉带1540和1542可从图155中示出的第一位置到图156中示出的第二位置向着定位在相对的顶面1553的砧座向上行进穿过腔1552和1554。当钉带1540和1542行进到图153所示的位置中时，桥接件1538可压靠在钉仓1550的剪切部1560。此后，钉带可被进一步向上推动，引起剪切部1560将桥接件1538从一个或多个钉1541上断开，如上所述。参见图154，腔1552中的剪切部1560包括从其上延伸并被构造成将桥接件1538在位置1564处从钉冠1531上断开的突起1562(图151)。
在这里描述的任何一种实施方式中，包覆模制到钉上形成钉冠1513和桥接件1526、和/或桥接件1508的材料可包括可溶解、可生物吸收或者可生物分解材料。此外，与上面类似，在各种实施方式中，可生物吸收材料可包括例如至少一种混合到其中或者涂敷到其上的治疗药物。与上面类似，在各种实施方式中，驱动器可与钉的钉冠连接和/或与其一体模制成。
在替代实施方式中，代替带，钉例如可以“盘(puck)”构型连接。在各种实施方式中，参见图158，钉盘1571和1572包括通过桥接件1574和1575相互连接的钉1506。钉盘1571具有通过两个桥接件1574和两个桥接件1575相互连接的五个钉。如图158所示，桥接件1575连接相邻的钉1506，使它们的钉冠1513的顶部大体上彼此齐平，但是，桥接件1574连接相邻钉1506，使它们的钉冠1513的顶部彼此在垂直方向交错。类似地，钉盘1572包括由两个桥接件1574和两个桥接件1575相互连接的四个钉1506。
参见图159和159A，钉仓1576包括尺寸和构造设置成容纳钉盘1571的腔1577，并包括尺寸和构造设置成容纳钉盘1572的腔1578。参见图160，钉仓1576进一步包括尺寸和构造设置成分别将钉盘1571和1572支撑于其上的驱动器1579和1580。更具体地说，参见图161-163，驱动器1579和1580可包括剪切部1581，钉盘1571和1572被支撑在剪切部1581上。在被插入到腔1577和1578中之后，参见图163，桥接件1574和1575被定位在剪切部1581上方。在使用时，如上所述，驱动器1579和1580通过凸轮滑动件向着钉仓1576的仓板1582升高。但是，参见图163，一旦驱动器1579和1580接触桥接件1574和1575，并且钉盘1571和1572的向上运动被钉仓1576阻止，驱动器1579和1580的进一步向上运动引起剪切部1581将桥接件1574和1575断开，从而将钉1306分开。一旦桥接件1574和1575已经断开，驱动器1579和1580的支撑面1582被构造成向着砧座向上推动钉1306，如上所述。参见图164和164A，替代钉仓1583被示出，其具有尺寸和构造设置成容纳钉盘的替代构造的凹槽。
在本发明的至少一种实施方式中，参见图165和166，钉盘1584和1585可被构造成使与钉1587相互连接的桥接件1586例如包括从其上延伸的剪切部1588。在本实施方式中，参见图167，剪切部1588可被构造成切割钉仓1590的仓板1589。更具体地说，当钉盘1585由凸轮滑动件1591升高时，例如，剪切部1588可穿破仓板1589，使钉盘1585在被放置时可升高到仓板1589之上。结果，钉1587可在钉仓1590从外科部位除去之前从钉仓1590完全被放置。在替代实施方式中，虽然没有示出，钉仓还可包括将钉1587从桥接件1586上分开的剪切部，和/或在剪切部1588已经切开钉仓仓板1589之后还包括剪切部1588。与上面类似，桥接件1589可包括被构造成与凸轮滑动件1591协作的倾斜表面1592。
参见图168，钉1465每个都可包括第一可变形腿部1466、第二可变形腿部1467以及连接可变形腿部1466和1467的基部1468。与具有大体上与其腿部共面的基部的现有钉不同，基部1468可沿着横向于由腿部1466和1467限定的平面的至少一个方向延伸。更具体地说，基部1468可包括第一部分1469和第二部分1470，第一部分1469和第二部分1470分别从腿部1466和1467侧向延伸并在第一部分1469和第二部分1470之间形成一角度。在本实施方式中，参见图169，第一部分1469相对于第二部分1470形成大约90度的角度。但是，本发明不限于90度的角；而是任何合适的角度都可被使用。更具体地说，第一部分1469和第二部分1470之间的角度在一些实施方式中可以是大于90度的角度，在其他实施方式中可以是小于90度的角度。此外，在其他实施方式中，基部1468可包括多个大体上线性的段和/或弧形部分。
钉1465可进一步包括包覆模制在基部1468上的钉冠1471。更具体地说，由于如上所述的基部1468的构造，钉冠1471也可相对于由腿部1466和1467之间限定的平面横向延伸。参见图168和169，钉冠1471可包括尺寸和构造设置成用于将组织支撑于其上的组织接触表面1472。由于钉冠1471的结构，组织接触表面1472可比现有钉的组织接触表面更大。因此，更大的接触表面可降低作用在捕获于钉内的组织上的局部压强。如同该技术领域中已知的那样，降低该局部压强可降低组织坏死的可能性而不减小作用在组织上的压缩力。换言之，作用于组织上的压强是作用于组织上的力除以其作用面积的函数。增大面积可降低局部压强同时不降低由钉施加的夹钳力。
此外，由于基部1468和钉冠1471的缘故，钉冠1471的更大表面积可在钉已经被放置到组织中之后改善钉冠1471和周围组织的稳定性。更具体地说，在现有钉被放置之后，这些现有钉的相对较窄的钉冠不能防止钉相对于组织摇摆或者不能防止钉张紧围绕钉周围的组织。由于钉冠1471的构造，钉1465可降低并可能消除这些现有技术的问题。更具体地说，由于更大接触表面1472的缘故，钉冠1471更稳定，即其不太可能相对于组织旋转。此外，由于现有钉更窄的构造的缘故，现有钉的钉冠会切割经过下面的组织。由于钉冠1471的更大构造的缘故，钉1465可减少甚至消除这种可能性。在替代实施方式中，参见图173，钉组件1479可包括钉1400的多个“J”形可变形构件(图122和123)。
为了进一步改善钉1465的稳定性，例如，两个相邻钉1465可通过桥接件1473连接在一起。更具体地说，参见图168和169，第一钉的基部1468和钉冠1471可沿着一个方向侧向设置，并且第二钉的基部1468和钉冠1471可沿着相反方向侧向设置。这些相对设置的部件可通过提供在组件的相对侧上的稳定表面而改善钉的稳定性。参见图172，两个钉可从钉仓1475中由凸轮滑动件1474同时放置。为了便于钉放置，与上面类似，钉仓1475可包括槽1476，槽1476的尺寸和构造被设置成容纳从钉1465的钉冠1471延伸的键1477。更具体地说，键1477和槽1476可被构造成将钉1465相对于钉仓1475的运动限制成大体上为线性向上运动。另外，与上面类似，每个桥接件1473可包括被构造成与凸轮滑动件1474协作的一体驱动器1478。在至少一种实施方式中，钉冠1471、桥接件1473和驱动器1478可包括可溶解或者可生物吸收材料。
如同在本领域已知的那样，钉可被放置到组织中，使钉成排对准。但是，在过去，由于在钉之间的可能泄露通道，被构造成对角模式(diagonal pattern)的钉受到限制。本发明的钉可克服这些现有问题。参见图174和175，钉1480每个都包括从钉冠1482延伸的两个可变形构件1481和连接钉冠1482的桥接件1483。当钉1480被插入组织中时，如上所述，组织在钉冠1482与可变形构件1481之间被压缩。但是，在其中桥接件1483与钉1480一道被插入到身体中的实施方式中，桥接件1483还可压缩组织并闭合其间的任何泄露通道。参见图175，钉仓1484中包括被构造成容纳对角模式的钉1480的凹槽1485，使钉1480可被如上所述地放置到组织中。
在替代实施方式中，在钉放置过程中一部分钉仓可从其上断裂。该部分可被构造成定位在钉的基部与捕获在钉中的组织中间。更具体地说，参见图176-178，外科缝合系统可包括具有与钉仓1486的仓板1488一体模制成的钉垫1487的钉仓1486。钉仓1486可包括刻痕标记1489和围绕钉垫1487的槽1490，使钉垫1487可以很容易与仓板1488分离。更具体地说，参见图178，缝合系统可包括具有剪切部1492的驱动器1491，剪切部1492被构造成当基部1493紧紧靠近钉架1494时压靠钉垫1487并且“冲切”钉垫1487。在至少一种实施方式中，在钉垫已经被冲切掉之后，钉垫可被定位在基部1493与被捕获在钉中的组织之间。结果，钉垫1487可被构造成作为钉的钉冠起作用，或者在替代实施方式中，作为在钉与组织中间的支承构件起作用。在至少一种实施方式中，与上面类似，钉垫1487可包括可生物吸收材料。
上面描述的钉可在各种外科技术中使用。例如，一种外科技术可包括横切组织或者中空器官的方法，所述方法包括如下步骤：将包括至少一个上面描述的钉的外科缝合系统定位在待横切组织附近，致动该外科缝合系统以将组织压缩在一起，致动外科缝合系统以使用钉紧固并分开组织，和从手术部位除去外科缝合系统。在至少一种实施方式中，外科技术可包括吻合两个中空器官和/或固定至少两个组织。

Claims (10)

1.一种能够插入到组织中的外科紧固件(1360，1370，1380)，所述紧固件包括：
钉冠(1302)；
从所述钉冠(1302)延伸的可变形的第一构件(1344)；和
从所述钉冠(1302)延伸的弹簧(1362，1372，1382)，所述弹簧被构造成偏压所述组织以使组织抵靠所述可变形的第一构件(1344)。
2.根据权利要求1所述的外科紧固件(1360，1370，1380)，其中，所述紧固件还包括从所述钉冠(1302)延伸的可变形的第二构件(1344)，所述弹簧(1362，1372，1382)被构造成偏压所述组织以使组织抵靠所述可变形的第二构件。
3.根据权利要求1所述的外科紧固件(1370)，其中，所述弹簧(1372)包括第一端部(1373)和第二端部(1374)，所述第一端部连接到所述钉冠，所述第二端部被构造成相对于所述第一端部运动。
4.根据权利要求1所述的外科紧固件(1380)，其中，所述弹簧(1382)包括第一端部(1383)和第二端部(1384)，所述第一端部和第二端部连接到所述钉冠(1302)。
5.根据权利要求1所述的外科紧固件，其中，所述弹簧由泡沫材料构成。
6.根据权利要求1所述的外科紧固件(1360)，其中，所述弹簧(1362)包括第一弹性构件(1364)和第二弹性构件(1363)，所述第二弹性构件定位在所述第一弹性构件和所述钉冠中间。
7.根据权利要求6所述的外科紧固件，其中，所述弹簧与所述钉冠模制成一体。
8.根据权利要求1所述的外科紧固件(1360，1370，1380)，其中，所述弹簧(1362，1372，1382)和所述钉冠(1302)中的至少一个由可生物吸收材料构成。
9.一种能够在第一形状和第二形状之间变形的外科钉，所述钉包括：
钉冠(1302)；
可变形的第一构件(1344)，该可变形的第一构件从所述钉冠延伸；以及
可压碎构件，该可压碎构件在所述钉变形成所述第二形状之后定位在所述可变形的第一构件和所述钉冠中间。
10.根据权利要求9所述的外科钉，其中，所述可压碎构件被构造成偏压定位在所述可压碎构件和所述可变形的第一构件(1344)中间的组织以使组织抵靠所述可变形的第一构件。
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