CN103619268A - 包括具有不同特性的部分的组织厚度补偿件 - Google Patents
包括具有不同特性的部分的组织厚度补偿件 Download PDFInfo
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- CN103619268A CN103619268A CN201280031895.4A CN201280031895A CN103619268A CN 103619268 A CN103619268 A CN 103619268A CN 201280031895 A CN201280031895 A CN 201280031895A CN 103619268 A CN103619268 A CN 103619268A
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Abstract
紧固件仓可包括支撑部分、相对于所述支撑部分定位的组织厚度补偿件、以及定位在所述支撑部分和/或所述组织厚度补偿件中可用于紧固组织的多个紧固件。在使用中,紧固件仓可被定位在外科紧固装置的第一钳口中,其中第二钳口或砧座可被定位在所述第一钳口的对面。为部署紧固件,钉部署构件被推进穿过所述紧固件仓以使紧固件朝砧座运动。当紧固件被部署时,所述紧固件可捕获其中的组织厚度补偿件的至少一部分,连同正被紧固的组织的至少一部分。
Description
相关申请的交叉引用
本非临时性专利申请为根据35U.S.C.§120的2010年9月30日提交的名称为“Surgical Stapling Instrument With Interchangeable Staple CartridgeArrangements”的美国专利申请序列号12/894,322的部分继续申请,其全部公开内容据此以引用的方式并入本文。
背景技术
本发明涉及一种外科器械,并且在各种实施例中涉及被设计成用于切割和缝合组织的外科切割和缝合器械及其钉仓。
附图说明
通过结合附图来参考本发明实施例的以下说明,本发明的特征及优点及其获取方法将会变得更加明显,并可更好地理解发明本身,其中:
图1是外科器械实施例的剖视图;
图1A是植入式钉仓的一个实施例的透视图;
图1B-1E示出了用植入式钉仓夹持和缝合组织的端部执行器的多个部分;
图2是联接到外科器械的一部分的另一个端部执行器的局部横截面侧视图,其中端部执行器支撑外科钉仓并且其砧座处于打开位置;
图3是图2所示的端部执行器处于闭合位置的另一局部横截面侧视图;
图4是图2和图3所示的端部执行器在刀杆开始穿过端部执行器推进时另一局部横截面侧视图;
图5是图2至图4所示的端部执行器在刀杆被部分地推进穿过其中时的另一局部横截面侧视图;
图6是安装在外科切割和缝合装置中的可供选择的钉仓实施例的透视图;
图7是图6所示装置的外科钉仓和细长通道的顶视图;
图8是安装在端部执行器的细长通道中的另一个外科钉仓实施例的顶视图;
图9是砧座的底视图;
图10是形成钉行的一部分的多个钉的局部透视图;
图11是图10的钉行的另一个局部透视图,其钉为在由外科切割和缝合装置的砧座接触成形之后;
图12是形成另一钉行的一部分的可供选择的钉的局部透视图;
图13是形成另一钉行的一部分的可供选择的钉的局部透视图;
图14是形成另一钉行实施例的一部分的可供选择的钉的局部透视图;
图15是支撑钉仓的端部执行器的剖视图;
图16是图15所示端部执行器的细长通道部在从其移除植入式钉仓主体部分和钉之后的剖视图;
图17是支撑另一个钉仓的端部执行器的剖视图;
图18A-18D根据至少一个实施例描绘定位在可塌缩钉仓体内的外科钉的变形;
图19A是示出定位在可压溃钉仓体中的钉的示意图;
图19B是示出图19A所示的可压溃钉仓体被砧座压溃的示意图;
图19C是示出图19A所示的可压溃钉仓体被砧座进一步压溃的示意图;
图19D是示出图19A所示的钉处于完全成形构型并且图19A所示的可压溃钉仓处于完全压溃状态的示意图;
图20是绘示抵靠钉仓支撑表面而定位的钉和示出钉与钉仓支撑表面之间的潜在相对运动的示意图;
图21是钉仓支撑表面的剖视图,所述钉仓支撑表面包括狭槽或槽,以稳定图20所示的钉的基部;
图22是根据至少一个可供选择的实施例的钉的剖视图,所述钉包括重叠注塑的冠部和能够容纳所述冠部的一部分的狭槽或槽;
图23是根据至少一个实施例的钉仓的顶视图,所述钉仓包括嵌入可塌缩钉仓体中的钉;
图24是图23所示钉仓的正视图;
图25是根据至少一个实施例的钉仓的正视图,所述钉仓包括围绕定位在可塌缩钉仓体内的钉的保护层;
图26是沿图25中的线26-26截取的图25所示钉仓的剖视图;
图27是根据至少一个实施例的钉仓的正视图,所述钉仓包括至少部分地延伸于可塌缩钉仓体外的钉和围绕所述钉仓体的保护层;
图28是沿图27中的线28-28截取的图27所示钉仓的剖视图;
图29是根据至少一个实施例的钉仓的局部切除视图,所述钉仓包括至少部分地嵌入可塌缩钉仓体中的钉,所述钉至少部分地位于所述钉仓体中的钉腔隙中;
图30是是沿图29中的线30-30截取的图29所示钉仓的剖视图;
图31是根据至少一个实施例的钉仓的局部切除视图;
图32是根据至少一个实施例的钉仓的局部切除视图,所述钉仓包括至少部分地嵌入可塌缩钉仓体内的钉以及连接所述钉并使所述钉相对于彼此对齐的对齐矩阵;
图33是沿图32中的线33-33截取的图32所示钉仓的剖视图;
图34是可压缩钉仓体的内层的局部切除视图;
图35是示出了在传送板和支撑板之间被压缩的图34所示的内层的示意图;
图36是示出钉被插入图35所示的经压缩的内层中的示意图;
图37是示出图35所示支撑板从内层被移除的示意图;
图38是示出包括图34所示内层和被插入外层中的图36所示钉的子组件的示意图;
图39是示出图38所示外层被密封以形成密封钉仓的示意图;
图40是图39所示密封钉仓的剖视图;
图41是根据至少一个实施例的钉仓和钉仓通道的剖视图;
图42是示出图41所示钉仓的一部分处于变形状态的示意图;
图43是外科缝合器的端部执行器的正视图,所述端部执行器包括处于打开位置的砧座和定位在钉仓通道内的钉仓;
图44是图43所示端部执行器的正视图,其示出处于闭合位置的砧座和被压缩于砧座与钉仓通道之间的钉仓;
图45是图43所示端部执行器的正视图,其示出图43所示的钉仓以替代方式位于钉仓通道内;
图46是外科缝合器的端部执行器的剖视图,所述端部执行器包括位于钉仓通道内的可压缩钉仓和附接到砧座的一块支撑材料;
图47是图46所示端部执行器的剖视图,其示出处于闭合位置的砧座;
图48是外科缝合器的端部执行器的可供选择的实施例的剖视图,所述端部执行器包括具有不透水层的钉仓;
图49是外科缝合器的端部执行器的另一可供选择的实施例的剖视图;
图50是外科缝合器的端部执行器的可供选择的实施例的剖视图,所述端部执行器包括阶梯式砧座和具有阶梯式仓体的钉仓;
图51是外科缝合器的端部执行器的另一可供选择的实施例的剖视图;
图52是外科缝合器的端部执行器的可供选择的实施例的剖视图,所述端部执行器包括倾斜的组织接触表面;
图53是外科缝合器的端部执行器的另一可供选择的实施例的剖视图,所述端部执行器包括倾斜的组织接触表面;
图54是外科缝合器的端部执行器的可供选择的实施例的剖视图,所述端部执行器包括能够支撑钉仓的支撑插入件;
图55是外科缝合器的端部执行器的可供选择的实施例的剖视图,所述端部执行器包括具有多个可压缩层的钉仓;
图56是外科缝合器的端部执行器的可供选择的实施例的剖视图,所述端部执行器包括具有阶梯式可压缩仓体的钉仓;
图57是外科缝合器的端部执行器的另一可供选择的实施例的剖视图,所述端部执行器包括具有阶梯式可压缩仓体的钉仓;
图58是外科缝合器的端部执行器的可供选择的实施例的剖视图,所述端部执行器包括具有弯曲的组织接触表面的钉仓;
图59是外科缝合器的端部执行器的可供选择的实施例的剖视图,所述端部执行器包括具有倾斜的组织接触表面的钉仓;
图60是可压缩钉仓的剖视图,所述可压缩钉仓包括钉且其中存储有至少一种药剂;
图61是示出图60所示的可压缩钉仓被压缩且其中所容纳的钉变形之后的示意图;
图62是根据至少一个实施例的钉仓的局部切除视图;
图63是图62所示钉仓的剖视图;
图64是根据至少一个可供选择的实施例的所植入钉仓的透视图;
图65是图64所示所植入钉仓的剖视图;
图66是钉仓的可供选择的实施例的透视图,所述钉仓包括自钉仓的外层延伸的可变形构件;
图67是钉仓的可供选择的实施例的透视图,所述钉仓包括组装至内层的钉仓外层;
图68是钉仓的可供选择的实施例的剖视图,所述钉仓包括多个钉、可压缩层、和脱脂棉层;
图69是图68所示脱脂棉层的透视图;
图70是从图68所示的脱脂棉层分割出的脱脂棉以及与脱脂棉中的沟槽对齐的钉的透视图;
图71是来自图68所示脱脂棉层的两个相连脱脂棉的透视图;
图72是图68所示脱脂棉层的脱脂棉支撑框架被从所分割出的脱脂棉移除的透视图;
图73是可压缩钉仓的可供选择的实施例的分解透视图,所述可压缩钉仓中包括钉和用于抵靠砧座而驱动钉的系统;
图73A是图73所示钉仓的可供选择的实施例的局部切除视图;
图74是图73所示钉仓的剖视图;
图75是能够横贯图73所示的钉仓并使钉朝砧座行进的滑动件的正视图;
图76是示出钉驱动器的示意图,所述钉驱动器可由图75所示的滑动件朝砧座提升;
图77是根据至少一个可供选择的实施例的钉仓的切除视图,所述钉仓包括位于钉驱动器内的钉;
图78是图77所示的钉仓位于钉仓通道内时的剖视图;
图79是图77所示钉仓的剖视图,其示出运动到闭合位置的砧座和通过砧座而变形的容纳于钉仓内的钉;
图80是图77所示钉仓的剖视图,其示出朝砧座向上运动的钉;
图81是钉仓的可供选择的实施例的透视图,所述钉仓包括连接钉仓的各柔性侧的带;
图82是滑动件和切割构件组件的透视图;
图83是示出使用图82所示的滑动件和切割构件组件来提升图77所示钉仓的钉的示意图;
图84是示出能够接合钉并朝砧座提升钉的滑动件和能够选择性地使滑动件向远侧运动的锁定系统的示意图;
图85A-85C示出将钉插入钉冠部中的过程;
图86是包括支撑盘或保持器的钉仓的剖视图;
图87是根据至少一个可供选择的实施例的可压缩钉仓的局部剖视图;
图88是示出图87所示的钉仓处于植入状态时的示意图;
图89是根据至少一个可供选择的实施例的可压缩钉仓的局部切除视图;
图90是图89所示钉仓的局部剖视图;
图91是示出图89所示的钉仓处于植入状态时的示意图;
图92是根据至少一个可供选择的实施例的可压溃钉仓的局部剖视图;
图93是根据至少一个实施例的包括多个可塌缩元件的可塌缩钉仓的局部切除视图;
图94是图93所示的可塌缩元件处于非塌缩状态时的透视图;
图95是图94所示的可塌缩元件处于塌缩状态时的透视图;
图96A是外科缝合器械的端部执行器的局部剖视图,所述端部执行器包括钳口、与所述钳口相对地定位的钉仓通道、以及位于所述钉仓通道内的钉仓,其中所述钳口包括附接到钳口的保持矩阵;
图96B是图96A所示端部执行器的局部剖视图,其示出朝钉仓通道行进的钳口、被砧座和保持矩阵压缩的钉仓、以及钉,所述钉至少部分地延伸穿过位于保持矩阵与钉仓中间的组织;
图96C是图96A所示端部执行器的局部剖视图,其示出处于最终位置的钳口和与图96B所示的钉接合的保持矩阵;
图96D是图96A所示端部执行器的局部剖视图,其示出钳口和钉仓通道远离植入的钉仓和保持矩阵运动;
图97是根据至少一个可供选择的实施例的保持矩阵的保持孔的透视图,所述保持孔包括多个保持构件,以用于接合延伸穿过所述保持孔的紧固件支腿;
图98是根据至少一个可供选择的实施例的保持矩阵的保持孔的透视图,所述保持孔包括六个保持构件;
图99是根据至少一个可供选择的实施例的保持矩阵的保持孔的透视图,所述保持孔包括八个保持构件;
图100是根据至少一个可供选择的实施例的保持矩阵的保持孔的透视图,所述保持孔包括多个保持构件,以用于接合延伸穿过所述保持孔的紧固件支腿;
图101是根据至少一个可供选择的实施例的保持矩阵的保持孔的透视图,所述保持孔包括六个保持构件;
图102是根据至少一个可供选择的实施例的保持矩阵的保持孔的透视图,所述保持孔包括八个保持构件;
图103是根据至少一个可供选择的实施例的保持矩阵的保持孔的透视图,所述保持孔包括由金属片冲压而成的多个保持构件;
图104是根据至少一个可供选择的实施例的保持矩阵的保持孔的透视图,所述保持矩阵包括沿所述保持孔的周边延伸的多个孔;
图105是根据至少一个可供选择的实施例的保持矩阵的保持孔的顶视图;
图106是根据至少一个可供选择的实施例的保持矩阵的保持孔的顶视图;
图107是根据至少一个可供选择的实施例的保持矩阵的保持孔的顶视图;
图108是根据至少一个可供选择的实施例的保持矩阵的保持孔的顶视图;
图109是根据至少一个可供选择的实施例的保持矩阵的保持孔的顶视图;
图110是根据至少一个实施例的保持矩阵的保持孔的顶视图,所述保持孔包括延伸至所述保持孔中的保持插片;
图111是根据至少一个可供选择的实施例的保持矩阵的保持孔的顶视图,所述保持孔包括延伸至所述保持孔中的保持插片;
图112是紧固系统的透视图,所述紧固系统包括多个钉、与所述钉接合的保持矩阵、以及能够对齐所述钉的对齐矩阵;
图113是图112所示保持矩阵的透视图;
图114是图112所示对齐矩阵的透视图;
图115是图112所示的保持矩阵与图112所示的钉接合时的局部顶视图;
图116是图112所示的保持矩阵与图112所示的钉接合时的局部底视图;
图117是图112所示紧固系统的局部正视图;
图118是图112所示紧固系统的局部透视图;
图119是图112所示的保持矩阵与图112所示的钉接合时的局部剖视图;
图120是图112所示紧固系统的局部剖视图;
图121是图112所示紧固系统的透视图,所述紧固系统还包括组装至钉腿的保护帽;
图122是图121所示紧固系统结构的底部透视图;
图123是图121所示紧固系统结构的局部透视图;
图124是图121所示紧固系统结构的局部剖视图;
图125是根据至少一个实施例的端部执行器的正视图,所述端部执行器包括处于打开位置的钳口、位于钳口中的保持矩阵和多个保护帽、以及位于钉仓通道中的钉仓;
图126是图125所示的端部执行器处于闭合位置时的正视图;
图127是图125所示的端部执行器处于击发位置时的正视图;
图128是图125所示的保持矩阵和保护帽组装至图125所示的钉仓时的正视图;
图129是图128所示结构的细部图;
图130是图125所示端部执行器的正视图,其示出处于打开位置的钳口和位于保持矩阵与钉仓之间的较薄组织;
图131是图125所示端部执行器的正视图,其示出抵靠图130所示的较薄组织而处于闭合位置的钳口;
图132是图125所示端部执行器的正视图,其示出处于击发位置以在保持矩阵与钉仓之间捕获图130所示较薄组织的钳口;
图133是图125所示保持矩阵和保护帽组装至图125所示的钉仓并使图130所示的薄组织位于其间时的正视图;
图134是图133所示结构的细部图;
图135是根据至少一个可供选择的实施例的位于钉腿末端上的保护帽的剖视图;
图136是嵌于材料片内的多个保护帽的透视图;
图137是钳口的透视图,所述钳口包括多个凹陷部以用于将多个保护帽容纳于其中;
图138是钳口的一部分的细部图,所述一部分包括用于覆盖位于图137所示钳口内的保护帽的薄片;
图139是根据至少一个可供选择的实施例的位于钉腿末端上的保护帽的剖视图,其中所述保护帽包括内部成形表面;
图140是图139所示保护帽的另一剖视图,其示出抵靠成形表面而变形的钉腿;
图141是保持矩阵的可供选择的实施例的顶视图,所述保持矩阵包括多个相连的矩阵元件;
图142是保持矩阵的可供选择的实施例的顶视图,所述保持矩阵包括多个相连的矩阵元件;
图143是保持矩阵的可供选择的实施例的顶视图,所述保持矩阵包括多个相连的矩阵元件;
图144是保持矩阵阵列的可供选择的实施例的顶视图,所述保持矩阵阵列包括多个相连的矩阵元件;
图145是保持矩阵的可供选择的实施例的顶视图,所述保持矩阵包括多个相连的矩阵元件;
图146是包括保持矩阵的钳口的部分分解视图,所述保持矩阵包括可压缩盖;
图147是图146所示保持矩阵的细部图;
图148是包括保持矩阵的紧固系统的局部剖视图,所述保持矩阵包括可压缩层和包封一种或多种药物的多个单元;
图149是示出钉腿在与保持矩阵接合时刺穿图148所示单元的示意图;
图150是包括保持矩阵的紧固系统的局部剖视图,所述保持矩阵包括可压缩层;
图151是紧固件仓插入组件的正视图,所述紧固件仓插入组件包括夹持器、第一紧固件仓、和第二紧固件仓;
图152是外科缝合器的端部执行器的正视图,所述外科缝合器包括第一钳口和第二钳口,所述第二钳口被示为处于开口构型;
图153是图152所示端部执行器的正视图,其示出处于闭合构型的第二钳口以及用于为第一钳口加载第一仓且为第二钳口加载第二仓的图151所示的紧固件仓插入组件;
图154是已加载的图153所示端部执行器的正视图,其示出自端部执行器移除的仓插入组件、再次处于开口构型的第二钳口、以及位于第一钳口与第二钳口中间的组织;
图155是图154所示已加载的端部执行器处于击发构型的正视图;
图156是处于植入状态的第一仓和第二仓的正视图;
图157是图152所示端部执行器的正视图,其根据至少一个实施例示出仍与第一钳口接合的第一仓的一部分;
图158是紧固件仓插入组件的可供选择的实施例的正视图,所述紧固件仓插入组件包括夹持器、第一紧固件仓、和第二紧固件仓;
图159是用于为端部执行器的第一钳口加载第一仓且为第二钳口加载第二仓的图158所示紧固件仓插入组件的正视图;
图160是图159所示已加载端部执行器的剖视图;
图161是根据至少一个实施例的包括底部钳口和顶部钳口的外科缝合器的透视图,其中外科缝合器的某些部分已被移除;
图162是已移除顶部钳口的图161所示外科缝合器的透视图;
图163是图161所示外科缝合器的顶部钳口的可滑动砧座系统的透视图,所述可滑动砧座系统包括第一可滑动砧座和第二可滑动砧座;
图164是图163所示可滑动砧座系统的端视图;
图165是图163所示可滑动砧座系统的顶视图;
图166是示出图163所示的可滑动砧座系统处于未击发状态的示意图;
图167是示出图163所示可滑动砧座系统的第一可滑动砧座处于未击发位置且位于底部钳口内的钉处于未部署位置的示意图;
图168是示出位于底部钳口中的钉处于已部署构型且图167所示第一可滑动砧座被拉向近侧以使第一组钉的钉腿变形的示意图;
图169是示出图168所示第一组钉变形至完全变形状态的示意图;
图170是示出图163所示可滑动砧座系统的第二可滑动砧座被推向远侧以使第二组钉腿变形的示意图;
图171是根据至少一个实施例的包括多个成形凹坑的砧座的局部透视图;
图172是图171所示砧座的横截面端视图;
图173是示出制造图171所示成形凹坑的第一步骤的示意图;
图174是示出制造图171所示成形凹坑的第二步骤的示意图;
图175是图171所示砧座的成形凹坑结构的顶视图;
图176是示出用于制造砧座的制造工艺的第一步骤的示意图;
图177是示出图176所示制造工艺的第二步骤的示意图;
图178是示出图176所示制造工艺的第三步骤的示意图;
图179是外科缝合和切断器械的左前透视图,其中柄部部分包括连杆触发的自动回缩机构和棘轮手动回缩机构;
图180是图179的外科缝合和切断器械的右后透视图,其中细长轴的一部分被切除并且柄部外壳的右半壳被移除以显示自动击发端行进回缩机构以及手动击发回缩机构;
图181是图179的外科缝合和切断器械的柄部部分和细长轴的右后透视分解视图;
图182是图31的外科缝合和切断器械的右后透视图,其中右半壳和工具部分的外部被移除以显示处于初始状态的闭合和击发机构;
图183是图182的部分分解的外科缝合和切断器械的右侧立面视图;
图184是图182的部分分解的外科缝合和切断器械的右后透视图,其中闭合机构闭合且夹紧,并且侧棘爪击发机构完成第一冲程,并且其中手动回缩机构被移除以显示连杆式齿条的远侧连杆,该远侧连杆触发击发机构的自动回缩;
图185是图183的部分分解的外科缝合和切断器械的右后透视图,其中侧棘爪击发机构脱离并且远侧连杆接近自动回缩;
图186是处于初始状态的图183的部分分解的外科缝合和切断器械的左侧立面视图,在该初始状态时,端部执行器打开并且防倒退机构被接合;
图187是图186的柄部部分的右半壳和防倒退释放杠杆的左侧细部图;
图188是图179的分解的外科缝合和切断器械的左侧细部立面视图,其中闭合触发器被夹紧、击发触发器执行最后冲程、并且远侧连杆被定位成触发自动回缩;
图189是远侧连杆已朝向防倒退释放杠杆致动并锁定,从而使连杆式齿条回缩后的图188的分解的外科缝合和切断器械的左侧细部立面视图;
图190是图179的外科缝合和切断器械的手动回缩机构的空转齿轮和后齿轮以及手动回缩杠杆和棘轮制转杆的右分解透视图;
图191是图190的手动回缩机构的右透视图,其中手动回缩杠杆被部分切除以在接合棘轮制转杆的后齿轮上露出较小直径的棘轮齿轮;
图192是图179的外科缝合和切断器械的部分分解的左侧立面视图,其中防倒退机构接合到完全击发的连杆式齿条,在图190的手动回缩杠杆制动之前,该连杆式齿条与组合的张力/压缩弹簧脱离;
图193是图192的外科缝合和切断器械的部分分解的左侧立面视图,其中防倒退释放杠杆、后齿轮、以及手动击发释放杠杆的隐藏部分以虚线显示;
图194是当手动击发释放杠杆的致动已使连杆式齿条手动回缩后的图193的外科缝合和切断器械的部分分解的左侧立面视图;
图195是图194的外科缝合和切断器械的部分分解的左侧立面视图,其中连杆式齿条被省略,示出了手动击发释放杠杆与防倒退机构脱离;
图196是用于图179的外科缝合和切断器械的可供选择的防倒退释放杠杆和柄部外壳的左侧细部图;
图197是图196的可供选择的防倒退释放杠、后齿轮轴以及自动回缩凸轮的左透视分解视图;
图198是图196的可供选择的防倒退释放机构的右侧立面视图,其中连杆式齿条处于回缩位置,并且防倒退释放杠杆朝近侧被定位在接合到击发连杆的防倒退板内;
图198A是图198的后齿轮、自动回缩凸轮以及最远侧连杆的右侧细部立面视图;
图199是在第一击发冲程之后的图198的防倒退释放机构的右侧立面视图;
图199A是图199的后齿轮、自动回缩凸轮以及第二连杆的右侧细部立面视图;
图200是在第二击发冲程之后的图199的防倒退释放机构的右侧立面视图;
图200A是图200的后齿轮、自动回缩凸轮以及第三连杆的右侧细部立面视图;
图201是在第三击发及最后冲程之后的图200的防倒退释放机构的右侧立面视图;
图201A是图201的后齿轮、自动回缩凸轮以及最近侧第四连杆的右侧细部立面视图;
图202是在另一个击发冲程使自动回缩凸轮朝远侧滑动并锁定防倒退释放杠杆,从而与防倒退释放机构分离之后的图201所示的自动释放机构的右侧立面视图;
图203是打开的钉施用组件的左前透视图,其中可替换钉仓的右半部分被包括在钉槽内;
图204是图203所示的具有完整的可替换钉仓和非关节运动的轴构型的钉施用组件的分解透视图;
图205是图203所示的钉施用组件的拼合式刀和击发杆(E型横梁)的透视图;
图206是钉施用组件的钉仓的楔形滑动件的透视图;
图207是沿图203所示的钉施用组件的中心线207-207在纵向横截面中截取的左侧立面视图;
图208是图203所示的打开的钉施用组件的透视图,其中没有可替换钉仓、邻近拼合式刀和击发杆的中间销的钉槽的一部分,并且没有钉槽的远侧部分;
图209是沿图203所示的钉施用组件的中心线209-209在横截面中截取的前立面视图,示出了钉仓的内部钉驱动器以及拼合式刀和击发杆的各部分;
图210是大致沿图203所示的闭合的钉施用组件的纵向轴线207-207截取的左侧立面视图,以包括位于拼合式刀和楔形滑动件之间的中心接触点,但也侧向偏置以示出钉仓内的钉和钉驱动器;
图211是图210所示的钉施用组件的左侧细部立面视图,其中拼合式刀回缩稍多,这对于钉仓替换而言是典型的情况;
图212是图211所示的钉施用组件的左侧细部立面视图,其中拼合式刀开始击发,对应于图210所示的构型;
图213是在拼合式刀和击发杆已朝远侧击发后的图210所示的闭合的钉施用组件的左侧横截面立面视图;
图214是在钉仓的击发以及拼合式刀的回缩之后的图213所示的闭合的钉施用组件的左侧横截面立面视图;
图215是图214所示的钉施用组件的左侧横截面立面视图,其中拼合式刀被允许落入锁定位置中;
图216是根据本发明的至少一个实施例的钉仓的透视图,钉仓包括与外科缝合器械一起使用的刚性支撑部分和可压缩的组织厚度补偿件;
图217是图216所示的钉仓的部分分解图;
图218是图216所示的钉仓的完全分解图;
图219是图216所示的钉仓的另一个分解图,该钉仓没有覆盖组织厚度补偿件的包裹物;
图220是图216所示的钉仓的仓体或支撑部分的透视图;
图221是滑动件的顶部透视图,该滑动件能够在图216所示的钉仓内运动,以从钉仓部署钉;
图222是图221所示的滑动件的底部透视图;
图223是图221所示的滑动件的正视图;
图224是驱动器的顶部透视图,该驱动器能够支撑一个或多个钉并被图221所示的滑动件向上抬起以将钉从钉仓射出;
图225是图224所示的驱动器的底部透视图;
图226是能够至少部分地围绕钉仓的可压缩组织厚度补偿件的包裹物;
图227是钉仓的局部剖视图,钉仓包括刚性支撑部分和可压缩的组织厚度补偿件,示出了钉在第一序列期间从未击发位置运动到击发位置;
图228是图227所示的钉仓的正视图;
图229是图227所示的钉仓的细部正视图;
图230是图227所示的钉仓的横截面端视图;
图231是图227所示的钉仓的底视图;
图232是图227所示的钉仓的细部底视图;
图233是钉仓和处于闭合位置的砧座的纵向剖视图,钉仓包括刚性支撑部分和可压缩的组织厚度补偿件,示出了钉在第一序列期间从未击发位置运动到击发位置;
图234是图233所示的砧座和钉仓的另一个剖视图,示出了当击发序列完成之后处于打开位置的砧座;
图235是图233所示的钉仓的局部细部图,示出了处于未击发位置的钉;
图236是钉仓的横截面正视图,该钉仓包括刚性支撑部分和可压缩的组织厚度补偿件,示出了处于未击发位置的钉;
图237是图236所示的钉仓的细部图;
图238是钉仓和处于打开位置的砧座的正视图,钉仓包括刚性支撑部分和可压缩的组织厚度补偿件,示出了处于未击发位置的钉;
图239是钉仓和处于闭合位置的砧座的正视图,钉仓包括刚性支撑部分和可压缩的组织厚度补偿件,示出了处于未击发位置的钉以及被捕获在砧座和组织厚度补偿件之间的组织;
图240是图239所示的砧座和钉仓的细部图;
图241是钉仓和处于闭合位置的砧座的正视图,钉仓包括刚性支撑部分和可压缩的组织厚度补偿件,示出了处于未击发位置的钉,示出了被定位在砧座和钉仓之间的较厚的组织;
图242是图241所示的砧座和钉仓的细部图;
图243是图241所示的砧座和钉仓的正视图,示出了被定位在砧座和钉仓之间的具有不同厚度的组织;
图244是图241所示的砧座和钉仓的细部图,如图243所示;
图245是示出了对捕获在不同钉内的不同组织厚度进行补偿的组织厚度补偿件的示意图;
图246是示出了组织厚度补偿件向被钉行横切的一根或多根血管施加压缩压力的示意图;
图247是示出了其中一个或多个钉未恰当成形的情况的示意图;
图248是示出了可补偿未恰当成形钉的组织厚度补偿件的示意图;
图249是示出了被定位在多个钉行相交的组织区域中的组织厚度补偿件的示意图;
图250是示出了捕获在钉内的组织的示意图;
图251是示出了捕获在钉内的组织和组织厚度补偿件的示意图;
图252是示出了捕获在钉内的组织的示意图;
图253是示出了捕获在钉内的厚组织和组织厚度补偿件的示意图;
图254是示出了捕获在钉内的薄组织和组织厚度补偿件的示意图;
图255是示出了捕获在钉内的组织厚度补偿件以及具有中间厚度的组织的示意图;
图256是示出了捕获在钉内的组织厚度补偿件以及具有另一中间厚度的组织的示意图;
图257是示出了捕获在钉内的厚组织和组织厚度补偿件的示意图;
图258是外科缝合器械的端部执行器的局部剖视图,示出了处于回缩、未击发位置的击发杆和钉击发滑动件;
图259是图258所示的端部执行器的另一个局部剖视图,示出了处于局部推进位置的击发杆和钉击发滑动件;
图260是图258所示的端部执行器的剖视示意图,示出了处于完全推进或击发位置的击发杆;
图261是图258所示的端部执行器的剖视图,示出了在被击发后处于回缩位置的击发杆、以及留在其完全击发位置的钉击发滑动件;
图262是图261所示的处于回缩位置的击发杆的细部图;
图263是包括钉仓的外科缝合器械的端部执行器的局部剖视图,该钉仓包括组织厚度补偿件和至少部分定位在其中的钉;
图264是图263所示的端部执行器的另一个局部剖视图,示出了相对于被定位在钉仓对面的砧座至少部分运动和/或旋转的钉;
图265是根据至少一个实施例的外科缝合器械的端部执行器的局部剖视图;
图266是根据至少一个可供选择的实施例的端部执行器的局部剖视图;
图267是根据另一个可供选择的实施例的端部执行器的局部剖视图;
图268是根据至少一个实施例的外科缝合器械的端部执行器的透视图;
图269是示出为处于挠曲状态的图268所示的端部执行器的局部剖视图;
图270是处于释放状态的图269所示的端部执行器的局部剖视图;
图271是包括组织厚度补偿件套的端部执行器的透视图;
图272是图271中的组织厚度补偿件套的后透视图;
图273是包括多个导轨的端部执行器的透视图,该多个导轨从支撑部分以及具有限定于其中的纵向腔体的组织厚度补偿件延伸;
图274是图273所示的组织厚度补偿件的透视图;
图275是端部执行器的透视图,该端部执行器包括从支撑部以及与其接合的组织厚度补偿件延伸的多个齿状物;
图276是根据至少一个实施例的包括凹坑阵列的砧座的透视图;
图277是图276所示的砧座的局部细部图;
图278是图276所示的砧座的局部纵向剖视图;
图279是图276所示的砧座的横向剖视图;
图280是包括基本上B形构型的击发钉的正视图;
图281是包括向内变形的一个腿和向外变形的一个腿的击发钉的正视图;
图282是包括向外成形的两个腿的击发钉的正视图;
图283是钉仓的支撑部分的局部透视图,该钉仓包括可拆卸和/或可替换的钉腿导向装置;
图284是图283所示的钉仓的局部剖视图,示出了从钉仓部署的钉;
图285是在钉仓已被击发后图284所示的剖视图的细部图;
图286是包括组织厚度补偿件的钉仓的分解图,该组织厚度补偿件包括限定于其中的空隙;
图287是示出了抵靠组织被植入的图286所示的组织厚度补偿件的示意图;
图288是示出了抵靠组织被植入的图286所示的组织厚度补偿件的另一个示意图;
图289是包括侧向保持构件的钉仓的横截面透视图,该侧向保持构件从其支撑部分延伸,能够将组织厚度补偿件保持就位;
图290是用于缝合组织的图289所示的钉仓的剖视图;
图291是图289所示的钉仓的另一个剖视图,示出了正运动远离植入的组织厚度补偿件的支撑部分;
图292是钉仓的横截面透视图,该钉仓包括能够将组织厚度补偿件保持到支撑部分的侧向保持构件;
图293是用于缝合组织的图292所示的钉仓的剖视图;
图294是图292所示的钉仓的另一个剖视图,示出了正运动远离植入的组织厚度补偿件的支撑部分;
图295是根据至少一个实施例的将组织厚度补偿件保持到钉仓的支撑部分的保持器的横截面细部图;
图296是根据至少一个实施例的包括具有不同高度的钉驱动器的钉仓的局部剖视图;
图296A是示出了图296所示的钉驱动器以及被支撑于其上的具有不同未击发高度的钉的示意图;
图297是示出了包括变化厚度的组织厚度补偿件、具有不同高度的钉驱动器、以及具有不同未成形高度的钉的示意图;
图298是示出了被植入组织的图297所示的钉和组织厚度补偿件的示意图;
图299是根据至少一个实施例的包括具有变化厚度的组织厚度补偿件的钉仓的局部剖视图;
图300是处于打开构型的外科缝合器械的端部执行器的剖视图;
图301是示出为处于部分击发构型的图300所示的端部执行器的剖视图;
图302是示出为处于再次打开构型的图300所示的端部执行器的剖视图;
图303是根据至少一个实施例的外科缝合器械的端部执行器的剖视图,该外科缝合器械包括具有不同高度和波状平台表面的钉驱动器;
图304是根据至少一个实施例的外科缝合器械的端部执行器的剖视图,该外科缝合器械包括具有不同高度和阶梯式平台表面的钉驱动器;
图305是使用钉仓施用装置加载到外科缝合器械的执行器中的钉仓的透视图;
图306是图305所示的钉仓施用装置的底部透视图;
图307是组装到钉仓的图305所示的钉仓施用装置的侧视图;
图308是图307所示的组件的剖视图;
图309是根据至少一个实施例的钉仓施用装置组件的透视图,该钉仓施用装置组件还包括定位在钉仓施用装置的顶部表面上的上部组织厚度补偿件;
图310是图309所示的上部组织厚度补偿件和钉仓施用装置的分解图;
图310A是包括牵拉构件的钉仓施用装置组件的分解图,该牵拉构件能够使附着到钉仓施用装置的上部组织厚度补偿件分离;
图311是根据至少一个可供选择的实施例的钉仓施用装置组件的部分分解图;
图312是钉仓施用装置组件的透视图,该钉仓施用装置组件包括上部组织厚度补偿件和钉仓,上部组织厚度补偿件包括从其延伸的多个保持结构并且钉仓包括下部组织厚度补偿件;
图313是图312所示的钉仓施用装置组件的正视图,该钉仓施用装置组件被定位在钉仓通道以及在钉仓施用装置组件上闭合的砧座内;
图314是处于再次打开位置的图313所示的砧座、以及正从端部执行器被移除的图312所示的钉仓施用装置的正视图;
图314A是被定位在图312所示的上部组织厚度补偿件和下部组织厚度补偿件中间的组织的剖视图;
图314B是示出了通过切割构件被缝合至组织、并被切断的上部组织厚度补偿件和下部组织厚度补偿件的剖视图;
图315是根据至少一个实施例的示出了将组织厚度补偿件插入砧座中的示意图;
图316是图315所示的组织厚度补偿件的剖视图;
图317是根据至少一个可供选择的实施例的组织厚度补偿件和砧座的分解图;
图318是根据至少一个实施例的钉仓施用装置组件的透视图,该钉仓施用装置组件包括能够附接到砧座的上部组织厚度补偿件;
图319是图318所示的钉仓施用装置组件的正视图,该钉仓施用装置组件被定位在钉仓通道以及正朝向上部组织厚度补偿件运动的砧座内;
图320示出了在上部组织厚度补偿件已与砧座接合之后,正从端部执行器被移除的图318所示的钉仓施用装置;
图321是朝向图318所示的上部组织厚度补偿件运动的砧座的横截面端视图;
图322是与上部组织厚度补偿件接合的砧座的横截面端视图;
图323是包括钉仓的外科缝合器械的端部执行器的剖视图,该钉仓包括通过多个紧固件附接到钉仓的支撑部分的可分段的组织厚度补偿件;
图324是图323所示的端部执行器的剖视图,示出了处于部分击发位置的击发构件;
图325是图323所示的端部执行器的剖视图,示出了正运动远离部分植入的组织厚度补偿件的支撑部分;
图326是图323所示的支撑部分的局部透视图;
图327是根据至少一个实施例的钉部署滑动件的透视图;
图328是图327所示的滑动件的正视图;
图329是包括钉仓的外科缝合器械的端部执行器的透视图,该钉仓包括组织厚度补偿件和定位在组织厚度补偿件上的多个钉导向装置;
图330是处于未击发构型的图329所示的组织厚度补偿件和钉导向装置的局部剖视图;
图331是处于击发构型的图329所示的组织厚度补偿件和钉导向装置的局部剖视图;
图332是根据至少一个实施例的包括组织厚度补偿件和支撑部分的钉仓的剖视图;
图333是组织厚度补偿件、钉导向层、以及处于未击发位置的钉的局部剖视图;
图334是根据至少一个可供选择的实施例的组织厚度补偿件、钉导向层、以及处于未击发位置的钉的局部剖视图;
图335是根据至少一个可供选择的实施例的组织厚度补偿件、钉导向层、以及处于未击发位置的钉的局部剖视图;
图336是根据至少一个可供选择的实施例的组织厚度补偿件、钉导向层、以及处于未击发位置的钉的局部剖视图;
图337是根据至少一个可供选择的实施例的组织厚度补偿件、钉导向层、以及处于未击发位置的钉的局部剖视图;
图338是根据至少一个可供选择的实施例的组织厚度补偿件、钉导向层、以及处于未击发位置的钉的局部剖视图;
图339是根据至少一个可供选择的实施例的组织厚度补偿件、钉导向层、以及处于未击发位置的钉的局部剖视图;
图340是围绕图339所示的钉的末端的区域的细部图;
图341是根据至少一个可供选择的实施例的组织厚度补偿件、钉导向层、以及处于未击发位置的钉的局部剖视图;
图342是围绕图341所示的钉的末端的区域的细部图;
图343是根据至少一个可供选择的实施例的组织厚度补偿件、钉导向层、以及处于未击发位置的钉的局部剖视图;
图344是根据至少一个可供选择的实施例的钉导向层和处于未击发位置的多个钉的透视图;
图345是能够与圆形外科缝合器一起使用的组织厚度补偿件的端视图;
图346是图345所示的组织厚度补偿件和圆形外科缝合器的透视图;
图347是根据至少一个可供选择的实施例能够与圆形外科缝合器一起使用的组织厚度补偿件的端视图;
图348是图347所示的组织厚度补偿件和圆形外科缝合器的透视图;
图349是能够与圆形外科缝合器一起使用的组织厚度补偿件的端视图;
图350是处于局部伸展构型的图349所示的组织厚度补偿件的端视图;
图351是根据至少一个实施例的包括钉仓的外科缝合器械的正视图;
图352是相对于组织定位的图351所示的外科缝合器械的端视图;
图353是图351所示的外科缝合器械的端视图,该外科缝合器械还包括定位在钉仓和组织之间的组织厚度补偿件;
图354是从不具有组织厚度补偿件的图351所示的外科缝合器械部署到组织中的钉的局部透视图;
图355是从具有组织厚度补偿件的图351所示的外科缝合器械部署到组织中的钉的局部透视图;
图356是图351所示的外科缝合器械的端部执行器的局部剖视图,包括处于第一位置的砧座板;
图357是图351所示的外科缝合器械的端部执行器的局部剖视图,示出了处于第二位置的图356所示的砧座板;
图358是包括钉仓的外科缝合器械的端部执行器的剖视图,该钉仓包括间隙设定元件;
图359是示出了击发构件的透视图,该击发构件在击发构件的击发冲程结束时切割图358所示的间隙设定元件;
图360是包括钉仓的外科缝合器械的端部执行器的剖视图,该钉仓包括柔性鼻部;
图361是图360所示的端部执行器的剖视图,示出了处于挠曲构型的鼻部;
图362是包括钉仓的外科缝合器械的端部执行器的剖视图,该钉仓包括可滑动部分;
图363是图362所示的端部执行器的剖视图,示出了朝远侧滑动的可滑动部分;
图364是包括支撑部分和组织厚度补偿件的外科缝合器械的端部执行器的剖视图,该支撑部分包括倾斜的平台表面并且该组织厚度补偿件包括变化的厚度;
图365是包括支撑部分和组织厚度补偿件的外科缝合器械的端部执行器的剖视图,该支撑部分包括倾斜的平台表面并且该组织厚度补偿件包括一致的厚度;
图366是包括具有变化厚度的组织厚度补偿件的钉仓的透视图;
图367是图366所示的钉仓的端视图;
图368是包括纵向层的组织厚度补偿件的横截面透视图;
图369是根据至少一个可供选择的实施例的包括多个层的组织厚度补偿件的横截面透视图;
图370是一次性加载单元的透视图,该一次性加载单元包括能够将组织厚度补偿件可释放地保持到其的保持构件;
图371是组织厚度补偿件的透视图,该组织厚度补偿件包括能够将组织厚度补偿件可释放地保持到一次性加载单元的保持构件;
图372是附接到一次性加载单元的图371所示的组织厚度补偿件的透视图;
图373是图372所示的一次性加载单元的端视图;
图374是组织厚度补偿件的透视图,该组织厚度补偿件包括能够将组织厚度补偿件可释放地保持到一次性加载单元的保持构件;
图375是附接到一次性加载单元的图374所示的组织厚度补偿件的透视图;
图376是图375所示的一次性加载单元的端视图;
图377是组织厚度补偿件的透视图,该组织厚度补偿件包括能够将组织厚度补偿件可释放地保持到一次性加载单元的保持构件;
图378是附接到一次性加载单元的图377所示的组织厚度补偿件的透视图;
图379是定位在一次性加载单元的执行器内的组织厚度补偿件施用装置的透视图;
图380是图379所示的组织厚度补偿件施用装置的顶部透视图;
图381是图379所示的组织厚度补偿件施用装置的底部透视图;
图382是根据至少一个可供选择的实施例定位在一次性加载单元的执行器内的组织厚度补偿件施用装置的透视图;
图383是图382所示的组织厚度补偿件施用装置的顶部透视图;
图384是图382所示的组织厚度补偿件施用装置的底部透视图;
图385是一次性加载单元的正视图,该一次性加载单元包括能够支撑钉仓的可枢转钳口;
图386是根据至少一个实施例的钉仓的剖视图,该钉仓包括附接到钉仓的支撑部分的组织厚度补偿件;
图387是根据至少一个实施例的钉仓的剖视图,该钉仓包括附接到钉仓的支撑部分的组织厚度补偿件;
图388是根据至少一个实施例的钉仓的剖视图,该钉仓包括附接到钉仓的支撑部分的组织厚度补偿件;以及
图389是图387所示的组织厚度补偿件的透视图。
贯穿多个视图,对应的参考符号指示对应的部件。本文示出的范例以一种形式示出了本发明的某些实施例,并且不应将此类范例理解为以任何方式限制本发明的范围。
具体实施方式
本申请的申请人还拥有以下美国专利申请,这些专利申请于2010年9月30日提交,并且每个都以引用的方式各自完全并入本文:
名称为“Surgical Stapling Instrument With a Variable Staple FormingSystem”的美国专利申请序列号12/894,360;
名称为“Surgical Stapling Instrument With Interchangeable StapleCartridge Arrangements”的美国专利申请序列号12/894,322;
名称为“Surgical Cutting and Fastening Instruments With Separate andDistinct Fastener Deployment and Tissue Cutting Systems”的美国专利申请序列号12/894,351;
名称为“Surgical Stapling Instrument With Compact Articulation ControlArrangement”的美国专利申请序列号12/894,339;
名称为“Jaw Closure Arrangements For Surgical Instruments”的美国专利申请序列号12/894,327;
名称为“Surgical Instruments With Reconfigurable Shaft Segments”的美国专利申请序列号12/894,311;
名称为“Surgical Staple Cartridges Supporting Non-Linearly ArrangedStaples and Surgical Stapling Instruments With Common Staple-FormingPockets”的美国专利申请序列号12/894,340;
名称为“Surgical Staple Cartridges With Detachable Support Structuresand Surgical Stapling Instruments With Systems For Preventing ActuationMotions When a Cartridge is Not Present”的美国专利申请序列号12/894,350;
名称为“Implantable Fastener Cartridge Having a Non-UniformArrangement”的美国专利申请序列号12/894,338;
名称为“Implantable Fastener Cartridge Comprising Multiple Layers”的美国专利申请序列号12/894,312;
名称为“Selectively Orientable Implantable Fastener Cartridge”的美国专利申请序列号12/894,377;
名称为“Implantable Fastener Cartridge Comprising BioabsorbableLayers”的美国专利申请序列号12/894,383;
名称为“Compressible Fastener Cartridge”的美国专利申请序列号12/894,389;
名称为“Fasteners Supported By a Fastener Cartridge Support”的美国专利申请序列号12/894,345;
名称为“Collapsible Fastener Cartridge”的美国专利申请序列号12/894,306;
名称为“Fastener System Comprising a Plurality of Connected RetentionMatrix Elements”的美国专利申请序列号12/894,318;
名称为“Fastener System Comprising a Retention Matrix and anAlignment Matrix”的美国专利申请序列号12/894,330;
名称为“Fastener System Comprising a Retention Matrix”的美国专利申请序列号12/894,361;
名称为“Fastening Instrument For Deploying a Fastener SystemComprising a Retention Matrix”的美国专利申请序列号12/894,367;
名称为“Fastener System Comprising a Retention Matrix and a Cover”的美国专利申请序列号12/894,388;
名称为“Fastener System Comprising a Plurality of Fastener Cartridges”的美国专利申请序列号12/894,376;以及
名称为“Implantable Fastener Cartridge Comprising a Support Retainer”的美国专利申请序列号12/894,369。
本申请的申请人还拥有以下美国专利申请,这些专利申请与本申请同一天提交,并且每个都以引用方式各自完全并入本文:
名称为“Compressible Staple Cartridge Assembly”的美国专利申请序列号____,代理人案卷号为END6848USCIP1/100533CIP1;
名称为“Staple Cartridge Comprising an Adjustable Distal Portion”的美国专利申请序列号____,代理人案卷号为END6847USCIP1/100532CIP1;
名称为“Tissue Thickness Compensator For a Surgical Stapler”的美国专利申请序列号____,代理人案卷号为END6736USCIP1/100060CIP1;
名称为“Surgical Stapler Anvil Comprising a Plurality of FormingPockets”的美国专利申请序列号__,代理人案卷号为END6735USCIP1/100059CIP1;
名称为“Staple Cartridge Loading Assembly”的美国专利申请序列号____,代理人案卷号为END6855USCIP1/100540CIP1;
名称为“Staple Cartridge Comprising a Variable Thickness CompressiblePortion”的美国专利申请序列号____,代理人案卷号为END6840USCIP1/100525CIP1;
名称为“Tissue Thickness Compensator Comprising DetachablePortions”的美国专利申请序列号__,代理人案卷号为END6842USCIP1/100527CIP1;
名称为“Tissue Thickness Compensator For a Surgical Stapler Comprisingan Adjustable Anvil”的美国专利申请序列号____,代理人案卷号为END6843USCIP1/100528CIP1;
名称为“Compressible Staple Cartridge Comprising AlignmentMembers”的美国专利申请序列号_,代理人案卷号为END6856USCIP1/100541CIP1;
名称为“Staple Cartridge Comprising a Releasable Portion”的美国专利申请序列号____,代理人案卷号为END6857USCIP1/100542CIP1;
名称为“Staple Cartridge Comprising Compressible Distortion ResistantComponents”的美国专利申请序列号____,代理人案卷号为END6858USCIP1/100543CIP1;
名称为“Staple Cartridge Comprising a Tissue Thickness Compensator”的美国专利申请序列号____,代理人案卷号为END6859USCIP1/100544CIP1;
名称为“Staple Cartridge Comprising Staples Positioned Within aCompressible Portion Thereof”的美国专利申请序列号____,代理人案卷号为END6841USCIP1/100526CIP1。
现在将描述某些示例性实施例,以从整体上理解本文所公开的装置和方法的结构、功能、制造和用途。这些实施例的一个或多个实例在附图中示出。本领域的普通技术人员将会理解,本文特别描述和在附图中示出的装置和方法为非限制性的示例性实施例,并且本发明各种实施例的范围仅由权利要求书限定。就一个示例性实施例进行图解说明或描述的特征,可与其他实施例的特征进行组合。这种修改形式和变化形式旨在包括在本发明的范围之内。
本说明书通篇引用的“各种实施例”、“一些实施例”、“一个实施例”或“实施例”等,是指结合所述实施例描述的具体特征、结构或特性包括在至少一个实施例中。因此,本说明书通篇出现的短语“在多个实施例中”、“在一些实施例中”、“在一个实施例中”或“在实施例中”等并不一定都指相同的实施例。此外,在一个或多个实施例中,具体特征、结构或特性可按任何合适的方式组合。因此,在无限制的情况下,结合一个实施例示出或描述的具体特征、结构或特性可全部或部分地与一个或多个其他实施例的特征、结构或特性结合。这种修改形式和变化形式旨在包括在本发明的范围之内。
本文所用术语“近侧”和“远侧”是相对于操纵外科器械柄部部分的临床医生而言的。术语“近侧”是指最靠近临床医生的部分,术语“远侧”是指远离临床医生的部分。还应当理解,为简洁和清楚起见,本文可以结合附图使用诸如“竖直”、“水平”、“上”和“下”之类的空间术语。然而,外科器械在许多方向和位置中使用,并且这些术语并非限制性的和/或绝对的。
提供了各种示例性装置和方法以执行腹腔镜式和微创外科手术操作。然而,本领域中的普通技术人员将容易理解,本文所公开的各种方法及装置可用于许多外科手术操作及应用(包括例如与开放式外科手术操作相结合的应用)中。继续参阅本具体实施方式,本领域中的普通技术人员将进一步理解,本文所公开的各种器械可以任何方式插入体内,例如通过自然腔道、通过形成于组织中的切口或穿刺孔等。器械的工作部分或端部执行器部分可被直接插入患者体内或可通过具有工作通道的进入装置插入,外科器械的端部执行器及细长轴可通过所述工作通道而推进。
参见附图,其中在多个视图中,类似的数字代表类似的元件,图1示出了能够实践本发明所特有的多种有益效果的外科器械10。外科缝合器械10被设计成用于操纵和/或致动可操作地附接到外科缝合器械10的各种形式及尺寸的端部执行器12。在图1-1E所示的实施例中,例如端部执行器12包括细长通道14,该细长通道形成端部执行器12的下钳口13。细长通道14能够支撑“植入式”钉仓30并且还活动地支撑用作端部执行器12的上钳口15的砧座20。
在各种实施例中,细长通道14可由例如300和400系列、17-4和17-7不锈钢、钛等制成,并且与间隔侧壁16一起形成。砧座20可由例如300和400系列、17-4和17-7不锈钢、钛等制成,并且具有钉成形下表面,通常标记为22,所述钉成形下表面具有多个形成于其中的钉成形凹坑23。参见图1B-1E。另外,砧座20具有从其向近侧突起的分为两部分的滑道组件24。砧座销26从滑道组件24的每个横向侧突起,以容纳在细长通道14的侧壁16中的对应狭槽或开口18中,从而有利于将砧座销可运动或可枢转地附接到所述对应狭槽或开口。
各种形式的植入式钉仓可与本文所公开的外科器械的各种实施例一起使用。以下将更详细地论述特定的钉仓构型和构造。然而,在图1A所示的实施例中,示出了植入式钉仓30。在至少一个实施例中,钉仓30具有主体部分31,该主体部分中支撑有多排未成形的金属钉32,主体部分由可压缩的止血材料(例如氧化再生纤维素(ORC)或可生物吸收的泡沫)组成。在至少某些实施例中,为防止钉受影响并防止止血材料在引入和定位过程期间被活化,整个仓可涂覆有或包裹有可生物降解的膜38,例如以商标出售的六环酮膜或以聚甘油癸二酸酯(PGS)膜、或以由PGA(聚乙醇酸,以商标Vicryl出售)、PCL(聚己内酯)、PLA或PLLA(聚乳酸)、PHA(聚羟基链烷酸酯)、PGCL(聚卡普隆25,以商标Monocryl出售)或由PGA、PCL、PLA、PDS的复合物形成的其他可生物降解的膜,所述膜只有在破裂时才可渗透。钉仓30的主体31的尺寸设定成可移除地支撑在如图所示的细长通道14内,使得当砧座20被驱动至与钉仓30成形接触时,其中的每个钉32均与砧座中对应的钉成形凹坑23对齐。
在使用中,一旦端部执行器12邻近靶组织而定位,端部执行器12便被操纵以将靶组织捕获或夹紧于钉仓30的顶部表面36与砧座20的钉成形表面22之间。钉32通过如下方式成形:在基本上平行于细长通道14的路径中运动砧座20,以使钉成形表面22尤其是其中的钉成形凹坑23基本上同时接触钉仓30的顶部表面36。当砧座20继续运动至钉仓30中时,钉32的腿34在砧座20中接触对应的钉成形凹坑23,该钉成形凹坑用于使钉腿34弯曲以使钉32成形为“B形”。砧座20朝细长通道14的进一步运动将会进一步压缩钉32,并使钉32成形为期望的最终成形高度“FF”。
上述钉成形过程大体绘示于图1B-1E中。例如,图1B示出端部执行器12,其中靶组织“T”位于砧座20与植入式钉仓30的顶部表面36之间。图1C示出砧座20的初始夹紧位置,其中砧座20已被合拢至靶组织“T”上,以将靶组织“T”夹紧于砧座20与钉仓30的顶部表面36之间。图1D示出初始钉成形,其中砧座20已开始压缩钉仓30,使得钉32的腿34开始通过砧座20中的钉成形凹坑23而成形。图1E示出穿过靶组织“T”而处于最终成形状态的钉32,为清晰起见已移除砧座20。一旦钉32成形并紧固至靶组织“T”,外科医生便运动砧座20至打开位置,以在从患者撤出端部执行器12时使仓体31及钉32能够保持附连到靶组织。当两个钳口13,15共同夹紧时,端部执行器12使所有的钉同时成形。其余“被压溃的”主体材料31用作止血剂(ORC)及钉行加固剂(PGA、PDS、或任何上述其他膜组合物38)。此外,由于钉32在成形期间不必离开仓体31,因此钉32在成形期间变为畸形的可能性被最小化。如本文所用,术语“植入式”是指除钉之外,用于支撑钉的仓体材料也将被保持在患者体内并可最终被患者身体吸收。此类植入式钉仓区别于先前的钉仓构造,该先前的钉仓构造在其已被击发之后仍然完整地定位在端部执行器内。
在各种具体实施中,端部执行器12能够联接到从柄部组件100突出的细长轴组件40。端部执行器12(在闭合时)及细长轴组件40可具有相似的横截面形状,并且其尺寸被设定成可操作地穿过套管针管或呈另一进入器械形式的工作通道。如本文所用,术语“可操作地穿过”是指端部执行器及细长轴组件的至少一部分可通过通道或管开口插入或可穿过通道或管开口,并可视需要在通道或管开口中对其进行操纵以完成外科缝合手术。在一些实施例中,当处于闭合位置时,端部执行器12的钳口13和15可为端部执行器提供大致圆形的横截面形状以利于其穿过圆形的通道/开口。然而,可设想本发明的各种实施例的端部执行器以及细长轴组件实施例具有其他横截面形状,从而可穿过具有非圆形横截面形状的进入通道及开口。因此,闭合的端部执行器的横截面的总体尺寸将与端部执行器将穿过的通道或开口的尺寸相关。因此,一个端部执行器例如可被称为“5mm”端部执行器,此是指其能够可操作地穿过直径至少为大约5mm的开口。
在多个实施例中,细长轴组件40可以具有与处于关闭位置的端部执行器12的外径基本相等的外径。例如,5mm端部执行器可联接到具有5mm横截面直径的细长轴组件40。然而,继续参阅本具体实施方式,将显而易见的是,本发明的各种实施例可有效地结合不同尺寸的端部执行器使用。例如,10mm端部执行器可附接到具有5mm横截面直径的细长轴。相反,对于其中提供10mm或更大的进入开口或通道的应用而言,细长轴组件40可具有10mm(或更大)的横截面直径,但也能够致动5mm或10mm端部执行器。因此,外轴40的外径可与附接到其的闭合的端部执行器12的外径相同或不同。
如图所示,细长轴组件40从柄部组件100大体沿直线向远侧延伸,以限定纵向轴线A-A。在各种实施例中,例如细长轴组件40可为大约9-16英寸(229-406mm)长。然而,细长轴组件40可设置为其他长度,并且在其他实施例中,细长轴组件中可具有接头或换句话讲能够有利于端部执行器12相对于轴或柄部组件的其他部分进行铰接,以下将更详细地论述。在各种实施例中,细长轴组件40包括脊构件50,该脊构件从柄部组件100延伸至端部执行器12。端部执行器12的细长通道14的近端具有从其突起的一对保持凸耳17,该对保持凸耳的尺寸设定成容纳在脊构件50的远端中所提供的对应的凸耳开口或支架52中,以使端部执行器12能够可移除地联接细长轴组件40。脊构件50可由例如6061或7075铝、不锈钢、钛等制成。
在各种实施例中,柄部组件100包括手枪抓握型壳体,所述手枪抓握型壳体可被加工成两个或更多个部分以用于组装。例如,如图所示的柄部组件100包括由聚合物或塑性材料模制或换句话讲加工成的、并被设计成配合在一起的右手壳体构件102和左手壳体构件(未示出)。可通过在其中模制或换句话讲形成的按扣结构、栓、和承窝、和/或通过粘合剂、螺钉等而将此类壳体构件附接到一起。脊构件50具有近端54,在该近端上形成有凸缘56。凸缘56能够旋转地支撑在沟槽106中,该沟槽由从壳体构件102,104中的每一者向内突起的配合肋108形成。这种结构有利于脊构件50附接到柄部组件100,同时使脊构件50能够相对于柄部组件100沿360°路径围绕纵向轴线A-A旋转。
如在图1中可进一步看出,脊构件50穿过安装轴衬60并由安装轴衬60支撑,该安装轴衬可旋转地附连到柄部组件100。安装轴衬60具有近侧凸缘62和远侧凸缘64,该近侧凸缘和远侧凸缘限定旋转沟槽65,该旋转沟槽能够将柄部组件100的前缘部分101可旋转地容纳在其间。这种结构使安装轴衬60能够相对于柄部组件100围绕纵向轴线A-A旋转。脊构件50通过脊销66不可旋转地销接至安装轴衬60。另外,旋转旋钮70附接到安装轴衬60。在一个实施例中,旋转旋钮70具有中空安装凸缘部72,该中空安装凸缘部的尺寸设定成将安装轴衬60的一部分容纳在其中。在各种实施例中,旋转旋钮70可由例如玻璃或碳填充尼龙、聚碳酸酯、等加工而成,并且也通过脊销66附连到安装轴衬60。另外,向内突起的保持凸缘74形成于安装凸缘部72上并能够延伸至形成于安装轴衬60中的径向沟槽68中。因此,外科医生可通过抓紧旋转旋钮70并使其相对于柄部组件100旋转而使脊构件50(及附接到脊构件50的端部执行器12)围绕纵向轴线A-A沿360°路径旋转。
在各种实施例中,砧座20由砧座弹簧21和/或另一个偏置构造保持在打开位置。砧座20可通过击发系统从打开位置选择性地运动至各种闭合或夹紧位置以及击发位置,所述击发系统一般被标记为109。击发系统109包括“击发构件”110,在各种实施例中,该“击发构件”包括中空击发管110。中空击发管110可在脊构件50上轴向运动,因此形成细长轴组件40的外部。击发管110可由聚合物或其他合适的材料加工而成,并具有附接到击发系统109的击发轭114的近端。例如在各种实施例中,击发轭114可模压至击发管110的近端。然而,也可采用其他紧固件结构。
如在图1中可看出,击发轭114能够可旋转地支撑在支撑衬圈120中,该支撑衬圈能够在柄部组件100中轴向运动。在各种实施例中,支撑衬圈120具有一对侧向延伸的翅片,该对翅片的尺寸设定成可滑动地容纳在形成于左手壳体构件和右手壳体构件中的翅片狭槽内。因此,支撑衬圈120可在柄部壳体100中轴向滑动,同时使击发轭114及击发管110能够相对于支撑衬圈120围绕纵向轴线A-A旋转。在各种实施例中,穿过击发管110设置有纵向狭槽,以使脊销66能够穿过纵向狭槽延伸至脊构件50中,同时有利于击发管110在脊构件50上轴向行进。
击发系统109还包括击发触发器130,该击发触发器用于控制击发管110在脊构件50上的轴向行进。参见图1。此类击发管110在远侧方向上的轴向运动产生与砧座20的击发相互作用在本文中称为“击发运动”。如在图1中可看出,击发触发器130通过枢轴销132可运动地或可枢转地联接联接到柄部组件100。采用扭转弹簧135来偏置击发触发器130使其远离柄部组件100的手枪式握把部107而到达未致动的“打开”或起始位置。如在图1中可看出,击发触发器130具有上部134,该上部可运动地附接(销接)到击发链节136,该击发链节可运动地附接(销接)到支撑衬圈120。因此,击发触发器130从起始位置(图1)向邻近柄部组件100的手枪式握把部107的结束位置运动将使击发轭114和击发管110沿远侧方向“DD”运动。击发触发器130远离柄部组件100的手枪式握把部107的运动(在扭转弹簧135的偏置作用下)将使击发轭114和击发管110在脊构件50上沿近侧方向“PD”运动。
本发明的各种实施例可与不同尺寸和构型的植入式钉仓一起使用。例如,当与第一击发衔接子140结合使用时,外科器械10可与用于支撑植入式钉仓30的大约20mm长(或具有其他长度)的5mm端部执行器12一起使用。这种端部执行器尺寸可尤其非常适用于例如实现相对精细的解剖及血管处理。然而,如下文所更详细所述,例如也可通过将第一击发衔接子140更换为第二击发衔接子而将外科器械10与其他尺寸的端部执行器和钉仓结合使用。在另一些实施例中,细长轴组件40能够附接到仅一种形式或尺寸的端部执行器。
现在将阐释一种用于将端部执行器12可移除地联接到脊构件50的方法。通过将细长通道14上的保持凸耳17插入脊构件50中的凸耳支架52中来开始联接过程。随后,外科医生将击发触发器130朝外壳组件100的手枪式握把107推进,以将击发管110和第一击发衔接子140朝远侧推进细长伸长通道14的近端部分47之上,从而将凸耳17保持在其各自的支架52中。第一击发衔接子140在凸耳17上的此类位置在本文中被称为“联接位置”。本发明的各种实施例也可具有端部执行器锁定组件,以用于在端部执行器12附接到脊构件50之后将击发触发器130锁定就位。
更具体地,端部执行器锁定组件160的一个实施例包括保持销162,该保持销可运动地支撑在击发触发器130的上部134中。如上所述,击发管110必须首先朝远侧被推进至联接位置,其中,第一击发衔接子140将端部执行器12的保持凸耳17保持在脊构件50中的凸耳支架52中。外科医生通过从起始位置朝手枪式握把107牵拉击发触发器130而将击发衔接子140向远侧行进至联接位置。当击发触发器130首先致动时,保持销162朝远侧运动,直到击发管110将第一击发衔接子140推进到联接位置,此时保持销162被偏置到形成于壳体构件中的锁定腔164中。在各种实施例中,当保持销162进入锁定腔164中时,销162可发出可听见的“咔嗒”声或其他声音,并会为外科医生提供端部执行器12已被“锁定”到脊构件50上的触觉指示。另外,只要不有意地将保持销162偏置出锁定腔164,外科医生便不会无意间致动击发触发器130以开始使端部执行器12中的钉32成形。相似地,如果外科医生释放处于联接位置的击发触发器130,则保持销162会使击发触发器130保持在该位置,以防止击发触发器130返回至起始位置并因此从脊构件50释放端部执行器12。
本发明的各种实施例还可包括击发系统锁定按钮137,该击发系统锁定按钮以能够枢转的方式附接到柄部组件100。在一种形式中,击发系统锁定按钮137具有在其远端上形成的闩锁138,该闩锁被取向成当击发释放按钮处于第一闩锁位置时闩锁138接合击发轭114。如在图1中可看出,闩锁弹簧139用于将击发系统锁定按钮137偏置到第一闩锁位置。在各种情况下,闩锁138用于在以下点处接合击发轭114:在该点处,脊构件50上的击发轭114的位置对应于其中第一击发衔接子140即将朝远侧前进到砧座20上的夹紧滑道28上的点。应当理解,随着第一击发衔接子140轴向地向夹紧滑道28上推进,砧座20将沿路径运动,使得钉成形表面部分22基本上平行于钉仓30的顶部表面36。
在端部执行器12联接到脊构件50之后,通过首先压下击发系统锁定按钮137而开始钉成形过程,以使击发轭114能够在脊构件50上进一步向远侧运动并最终将砧座20压缩至钉仓30中。在压下击发系统锁定按钮137之后,外科医生继续朝手枪式握把107致动击发触发器130,从而将第一钉衬圈140驱动到对应的钉成形滑道29上,以迫使砧座20与钉仓30中的钉32成形接触。击发系统锁定按钮137防止在外科医生准备好开始钉成形过程之前使钉32意外成形。在此类实施例中,外科医生必须在击发触发器130可被进一步致动之前压下击发系统锁定按钮137以开始钉成形过程。
外科器械10可视需要而仅用作组织缝合装置。然而,本发明的各种实施例也可包括组织切割系统,该组织切割系统一般被标记为170。在至少一种形式中,组织切割系统170包括刀构件172,可通过致动刀行进触发器200将该刀构件选择性地从邻近端部执行器12的近端的未致动位置推进到致动位置。刀构件172被活动地支撑在脊构件50中并附接到刀杆180或换句话讲从刀杆180突起。刀构件172可由例如具有大于38HRC(洛氏硬度C级)的硬度的420或440不锈钢加工而成,并可具有形成于其远端174上的组织切割刀刃176,并能够可滑动地延伸穿过砧座20中的狭槽以及在钉仓30中居中设置的狭槽33,以切穿夹紧于端部执行器12中的组织。在各种实施例中,刀杆180延伸穿过脊构件50并具有与刀传送装置传动交接的近端部分,该刀传送装置可操作地附接到刀行进触发器200。在各种实施例中,刀行进触发器200附接到枢轴销132,使得刀行进触发器200可在无需致动击发触发器130的情况下进行枢转或换句话讲被致动。在各种实施例中,第一刀齿轮192也附接到枢轴销132,使得刀行进触发器200的致动也使第一刀齿轮192枢转。第一刀齿轮192与柄部壳体100之间附接有击发返回弹簧202,以将刀行进触发器200偏置到起始位置或未致动位置。
刀传送装置的各种实施例也包括第二刀齿轮194,该第二刀齿轮可旋转地支撑在第二齿轮轴上并与第一刀齿轮192啮合。第二刀齿轮194与支撑在第三齿轮轴上的第三刀齿轮196啮合。第四刀齿轮198也支撑在第三齿轮轴195上。第四刀齿轮198能够传动接合位于刀杆180的近端上的一系列环形齿轮齿或环。因此,这种结构使第四刀齿轮198能够沿远侧方向“DD”或近侧方向“PD”轴向地驱动刀杆180,同时使击发杆180相对于第四刀齿轮198围绕纵向轴线A-A旋转。因此,外科医生可通过朝柄部组件100的手枪式握把107牵拉刀行进触发器200而使击发杆180轴向地推进并最终朝远侧推动刀构件172。
本发明的各种实施例还包括刀锁定系统210,该刀锁定系统防止刀构件172的推进,除非击发触发器130已被牵拉至完全击发位置。因此,这种结构将防止刀推进系统170的激活,除非钉已首先被击发或成形于组织中。如在图1中可看出,刀锁定系统210的各种具体实施包括刀锁定杆211,该刀锁定杆被以能够枢转的方式支撑在柄部组件100的手枪式握把部107中。刀锁定杆211具有激活端212,当击发触发器130处于完全击发位置时,激活端212能够被击发触发器130接合。另外,刀锁定杆211在其另一端上具有保持吊钩214,该保持吊钩能够以吊钩方式接合第一切割齿轮192上的闩锁杆216。采用刀锁定弹簧218来将刀锁定杆211偏置到“锁定”位置。在该“锁定”位置中,保持吊钩214保持与闩锁杆216接合,从而防止刀行进触发器200的致动,除非击发触发器130处于完全击发位置。
在钉被“击发”(成形)至靶组织中之后,外科医生可压下击发触发器释放按钮167,以使击发触发器130能够在扭转弹簧135的偏置作用下返回至起始位置,从而使砧座20能够在弹簧21的偏置作用下偏置到打开位置。当处于打开位置时,外科医生可撤出端部执行器12而留下植入式钉仓30和钉32。在其中端部执行器穿过通道、工作通道等插入的应用中,外科医生将通过激活击发触发器130而使砧座20返回至闭合位置,以使端部执行器12能够通过所述通道或工作通道被撤出。然而,如果外科医生想要在击发钉之后切割靶组织,则外科医生以上述方式激活刀行进触发器200,以驱动刀杆172穿过靶组织到达端部执行器的端部。随后,外科医生可释放刀行进触发器200,以使击发返回弹簧202能够使击发传送装置将刀杆172返回至起始(未致动)位置。一旦刀杆172返回至起始位置,外科医生便可打开端部执行器钳口13,15,以将植入式仓30释放于患者体内并随后从患者体内撤出端部执行器12。因此,此类外科器械有利于使用可通过相对较小的工作通道和通路而插入的小的植入式钉仓,同时为外科医生提供如下选择:在不切割组织的情况下击发钉、或视需要在击发钉之后还切割组织。
本发明的各种独特和新型实施例采用可压缩的钉仓,所述可压缩的钉仓支撑处于基本上固定位置以用于由砧座成形接触的钉。在各种实施例中,砧座被驱动到未成形钉中。其中,在至少一个此类实施例中,所达到的钉成形的程度取决于砧座被驱动到钉中多远。此类构造使得外科医生能够调节施加至钉的成形或击发压力的大小,从而改变钉的最终成形高度。在本发明的其他各种实施例中,外科缝合构造可采用钉驱动元件,该钉驱动元件可将钉朝向砧座抬起。下文对此类实施例进行了更详细的描述。
在各种实施例中,参照上述详细描述的实施例,施加到活动砧座的击发运动的大小取决于击发触发器的致动的程度。例如,如果外科医生想要获得仅部分成形的钉,则仅需朝手枪式握把107部分地向内压下击发触发器。要想获得更多的钉成形,外科医生仅需进一步压紧击发触发器,使得砧座被进一步驱动以与钉进行成形接触。如本文所用,术语“成形接触”是指钉成形表面或钉成形凹坑已接触钉腿的末端并已开始将腿成形或弯曲至成形位置。钉成形的程度是指钉腿被折叠的程度且最终是指上文所提及的钉的成形高度。本领域中的普通技术人员将进一步理解,因为在对砧座20施加击发运动时,砧座20是以与钉仓基本上平行的关系进行运动,所以钉基本上同时成形并具有基本上相同的成形高度。
图2和图3示出了可供选择的端部执行器12”,除以下能够容纳刀杆172’的不同点之外,端部执行器12”类似于上述端部执行器12’。刀杆172’联接到刀杆180或从刀杆180突起,并且除此之外以上文中关于刀杆172所述的方式进行操作。然而,在该实施例中,刀杆172’足够长以横贯端部执行器12”的整个长度,因此端部执行器12”中未采用单独的远侧刀构件。刀杆172’上形成有上横切构件173’和下横切构件175’。上横切构件173’被取向成可滑动地横切砧座20”中对应的细长狭槽250,并且下横切构件175’被取向成横切端部执行器12”的细长通道14”中的细长狭槽252。还在砧座20”中提供脱离狭槽(未示出),使得当刀杆172’被驱动到端部执行器12”中的结束位置时,上横切构件173’通过对应的狭槽下落,使砧座20”能够运动至打开位置,脱离被缝合和切割的组织。砧座20”可除此之外与上述砧座20相同,并且细长通道14”可除此之外与上述细长通道14相同。
在这些实施例中,砧座20”被弹簧或其他打开结构(未示出)偏置到完全打开位置(图2)。砧座20”通过击发衔接子150的轴向行进以上述方式在打开位置与完全夹紧位置之间运动。一旦击发衔接子150推进至完全夹紧位置(图3),外科医生随后便可以上述方式朝远侧使刀杆172”推进。如果外科医生想要将端部执行器用作抓紧装置来操纵组织,则可将击发衔接子朝近侧运动,以容许砧座20”远离细长通道14”运动,如图4中的虚线所示。在该实施例中,当刀杆172”朝远侧运动时,上横切构件173’和下横切构件175’同时牵拉砧座20”及细长通道14”,以在刀杆172”穿过端部执行器12”朝远侧推进时获得期望的钉成形。参见图5。因此,在此实施例中,钉成形与组织切割同时发生,但钉本身可在刀杆172”朝远侧被驱动时依序成形。
本发明的各种外科钉仓及外科器械的独特且新型的结构使所述钉仓中的钉能够排列成一个或多个线性或非线性的行。细长狭槽的每个侧上可设置有多个此类钉行,所述细长狭槽居中地设置在钉仓内,以用于穿过所述细长狭槽而容纳组织切割构件。在一种排列方式中,例如一个行中的钉可大体上平行于位于相邻钉行中的钉但与其错开。在另一些实施例中,一个或多个钉行可本质上为非线性的。换句话讲,钉行中的至少一个钉的基部可沿基本上与同一钉行中的其他钉的基部横切的轴线延伸。例如,如下文将更详细地论述,在可供选择的实施例中,细长狭槽的每个侧上的钉行可具有锯齿形外观。与现有技术的钉仓中所采用的各种线性钉排列方式相比,此类非线性的钉排列方式可使用更少的钉获得更好的组织紧固结果。
图6示出了端部执行器实施例612’中外科钉仓实施例900的使用。如在图6和图7中可看出,外科钉仓900的实施例具有仓体902,该仓体具有居中设置的细长狭槽904,该细长狭槽穿过近端903而延伸至与远端905相邻的区域。细长狭槽904能够在以上述方式进行组织切割操作期间容许刀主体穿过细长狭槽904轴向运动。在至少一个实施例中,仓体902由例如氧化再生纤维素(ORC)或例如由PGA(聚乙醇酸,以商标Vicryl出售)、PCL(聚己内酯)、PLA或PLLA(聚乳酸)、PDS(聚对二氧环己酮)、PHA(聚羟基链烷酸酯)、PGCL(聚卡普隆25,以商标Monocryl出售)或PGA、PCL、PLA及PDS的复合物加工而成的可生物吸收的泡沫等可压缩的止血材料组成,在所述可压缩的止血材料中支撑有未成形钉922形成的行920,930。然而,仓体902也可由其他材料加工而成,该材料用于将未成形钉922支撑在期望取向中,使得当砧座910’与未成形钉922接触时,未成形钉922可被压缩。与上述各种其他实施例一样,钉仓900为植入式的,且在缝合手术完成之后保持附接到被缝合的组织。在至少某些实施例中,为防止钉922受影响以及止血材料在引入和定位过程期间被活化,整个仓900可涂覆有或包裹于可生物降解的膜906中,例如以商标出售的六环酮膜或聚甘油癸二酸酯(PGS)膜、或例如由PGA(聚乙醇酸,以商标Vicryl出售)、PCL(聚己内酯)、PLA或PLLA(聚乳酸)、PHA(聚羟基链烷酸酯)、PGCL(聚卡普隆25,以商标Monocryl出售)或PGA、PCL、PLA、PDS的复合物形成的膜,所述膜只有在破裂时才可渗透。钉仓900的仓体902的尺寸设定成可移除地支撑在端部执行器612’的细长通道内。
在图6、图10、及图11所示的实施例中,外科钉仓900可操作地在细长狭槽904的一个横向侧907上支撑钉922形成的第一行920,并在细长狭槽904的另一横向侧909上支撑钉922形成的第二行930。在各种实施例中,钉922可由例如钛、钛合金(例如6Al-4V钛、3al-2.5V钛)、不锈钢等金属材料加工而成并具有钉基部924以及从钉基部924突起的两个直立的钉腿926。每个钉腿926上可形成有组织刺穿末端928。在钉922形成的第一行920中,至少一个钉922的钉基部924与另一钉922的钉基部重叠。在一个优选的实施例中,除位于第一钉行920每个末端上的最后钉922的基部924之外,每个钉922的钉基部924均与两个相邻钉922的钉基部924重叠。参见图10。因此,第一钉行920具有基本上非线性的形状。更具体地,当从上方观察时,第一钉行920具有基本上锯齿形的外观。
如在图9中可看出,砧座90具有两个顺序的纵向钉成形凹坑912,每个纵向钉成形凹坑912具有与钉922形成的第一行920的形状对应的基本上锯齿形的形状,使得当砧座910与钉922进行成形接触时,钉的腿926如图11所示成形。因此,一个钉的远侧腿与在纵向上的下一钉的近侧腿共享同一凹坑。这种结构能够形成更密集的凹坑图案,甚至达到钉自身进行相互作用(例如跨过彼此而折叠)的程度。在现有技术的钉凹坑结构中,一般来讲,一组凹坑与下一组凹坑之间必须具有0.005英寸至0.015英寸之间的金属/空间。然而,例如本发明的此类实施例具有0至0.02英寸的干涉/重叠间隔结构(本质上,a-0.020”),这是因为一个钉与下一个钉配合。这种结构使得能够在相同的空间中包括多出15%至30%的钉。此外,当各钉互锁时,对多个侧向钉排的需求减少。现有的结构通常在组织切割线的每个侧上采用三排钉,以防止存在血液可流过的开放路径。互锁钉行形成血液可流过的路径的可能性更小。本发明的各种互锁钉结构所提供的另一明显的优点涉及与撕开钉行开口所需力的大小相关的改良的“破裂强度”。
另一个钉成形凹坑构造可包括共用的钉成形凹坑。如本文所用,术语“共用的钉成形凹坑”是指,与其中针对每个预成形钉的每个腿来设置独立形成凹坑的现有技术的砧座设计不同,一个成形凹坑可使单个钉行中的所有钉成形。
图12示出另一钉实施例922’,其中基部924’具有偏置部929,以利于各基部924’进行更紧密的重叠。如上所述,钉仓900具有支撑在细长狭槽904的第二横向侧909上的钉922的第二行930。钉922的第二行930与钉922的第一行920基本上相同。因此,砧座910具有对应于第二钉行930的第二共用钉成形凹坑912,以与第二钉行930成形接触。然而,在可供选择的实施例中,钉922的第二行930可在形状上并可能在钉数目上不同于第一钉行920。
图8示出外科钉仓900’,除支撑在其中的钉922形成的行920’、930’之外,外科钉仓900’与上述钉仓900基本上相同。例如,在此实施例中,钉922的线920’相对于彼此设定成使得至少一个钉基部924的基部轴线S-S基本上横切至少一个另一相邻钉922的钉基部924的基部轴线S-S。当从上方观察时,此类预定的钉图案包括基本上锯齿形的排列。在图13所示的实施例中,钉922的各基部924上可另外重叠注塑有基部支撑构件927,如图所示。在各种实施例中,基部支撑构件927可由例如不可吸收的塑料(例如聚醚醚酮“PEEK”)或可吸收的塑料(例如聚乙醇酸“PGA”、聚乳酸“PLA”或“PLLA”、聚对二氧环己酮“PDS”、PCL(聚己内酯)、PHA(聚羟基链烷酸酯)、PGCL(聚卡普隆25,以商标Monocryl出售)或PGS、PDS、PLA、PGA、和PCL的各种复合混合物)加工而成。基部支撑构件927有利于在不使钉自身重叠的情况下使各钉之间进行互锁。因此,此类结构可在不使钉自身的腿重叠的情况下使钉成形为“B”形或倒“W”形。然而,由于冠部通过基部支撑构件相连,因此冠部像重叠的钉一样起作用。此类构造使组合凹坑具有针对每个腿的两条离散路径。
图14所示的实施例采用钉行920”,在钉行920”中,邻近钉922的腿926通过以模制或其他方式附接到腿926的联接器部分929联接在一起。每个联接器部分929可由例如聚醚醚酮“PEEK”或可吸收的塑料(例如聚乙醇酸“PGA”、聚乳酸“PLA”或“PLLA”、聚对二氧环己酮“PDS”、PCL(聚己内酯)、PHA(聚羟基链烷酸酯)、PGCL(聚卡普隆25,以商标Monocryl出售)或PGS、PDS、PLA、PGA、和PCL的各种复合混合物)加工而成。当从上方观察时,此类钉行920”具有基本上锯齿形的外观。尽管已结合端部执行器612’的使用来解释各种外科钉仓实施例900,900’,然而应当理解,钉仓900,900’可有效地与上文所述的各种其他端部执行器及外科器械一起使用。其中这些器械的砧座中设置有合适的钉成形凹坑结构,以便在砧座运动到与钉成形接触时达到期望的钉成形量。
图15和图16示出了被支撑在外科器械10的细长通道14中的另一个外科钉仓940实施例。在至少一个实施例中,外科钉仓940包括仓体942,该仓体具有居中设置的细长狭槽944,该细长狭槽至少部分地穿过仓体942延伸。细长狭槽944能够在以上述方式进行组织切割操作期间容许外科器械10的刀主体穿过细长狭槽944轴向地运动。在各种实施例中,仓体942由例如氧化再生纤维素(ORC)或上述或下述类型的可生物吸收的泡沫等可压缩的止血材料组成,所述止血材料中支撑有未成形钉922形成的行946,948,950,和952。在至少某些实施例中,为防止钉922受影响以及止血材料在引入和定位过程期间被活化,整个仓940可涂覆有或包裹于可生物降解的膜954中,例如以商标出售的六环酮膜或聚甘油癸二酸酯(PGS)膜、或例如由PGA(聚乙醇酸,以商标Vicryl出售)、PCL(聚己内酯)、PLA或PLLA(聚乳酸)、PHA(聚羟基链烷酸酯)、PGCL(聚卡普隆25,以商标Monocryl出售)或PGA、PCL、PLA、PDS的复合物形成的膜,所述膜只有在破裂时才可渗透。
在图15所示的实施例中,仓940还包括联接到仓体942的仓支撑构件960。在各种实施例中,仓支撑构件960可由例如钛、不锈钢、铝、上述材料形成的任何合金等刚性金属加工而成,并可部分地嵌入仓体942内。在各种实施例中,仓支撑构件960可由例如膜954保持就位。在需要限制性结合的另一些实施例中,可零星地使用氰基丙烯酸盐粘合剂来将两个元件“胶合”在一起。在另一些实施例中,可将仓体942加热并“焊接”或“熔融”至仓支撑构件960。在各种实施例中,仓支撑构件960形成仓体942的底部表面的至少一部分以与细长通道14配合。在至少一个实施例中,仓支撑构件960具有从其突起的一个或多个按扣结构962,用于将仓支撑构件960可释放地联接到细长通道14。可采用其他形式的按扣结构/紧固件结构将仓支撑构件960可释放地联接到细长通道14。
在各种实施例中,仓支撑构件960上形成有一系列支撑脊964,966,968,970,972,974,976,以向钉行946,948,950,952中的钉922的基部924提供一些侧向支撑,如图15所示。因此,在至少某些实施例中,支撑脊与钉行基本上共延。图17示出可供选择的与仓940基本上相同的钉仓实施例940’,不同之处在于,钉仓实施例940’包括分别从支撑脊964,966,968,970,972,976突起以对钉922提供额外侧向支撑的直立翅片部分978,979,980,981,982,983。在各种实施例中,翅片部分可与仓支撑构件960形成为一体,并且其高度可为大约1/2或小于仓高度。因此,在各种实施例中,例如用于支撑泡沫的任何直立结构均无法延伸到泡沫的最大压缩高度以上。因此,如果仓被设计成例如在被击发时压缩至其原始高度的1/3,则翅片将在未压缩高度的66%一路下降到未压缩高度的10%之间。
在使用中,一旦钉922通过以上述方式接触砧座20而成形,则将砧座20打开并将端部执行器12拉离经缝合的组织。当将端部执行器12拉离经缝合的组织时,仓体942保持紧固至经缝合的组织,并随后与保持联接到细长通道14的仓支撑构件960分离。在各种实施例中,仓支撑构件960的颜色不同于包括仓体942的材料的颜色以及细长通道14的颜色。此类布置为外科医生提供端部执行器中不存在钉仓的可容易识别的指示。因此,外科医生不会无意地试图在未在端部执行器中安装新的钉仓的情况下再次插入/使用端部执行器。为此,外科医生仅需使仓支撑构件960的按扣结构与细长通道14脱离,以使新的钉仓940的仓支撑构件960能够被放置在细长通道14中。尽管结合外科器械10解释钉仓940、940’,然而应当理解,在不背离本发明的实质和范围的条件下,这些仓可有效地与本文所公开的许多其他外科器械实施例一起使用。
在各种实施例中,钉仓可包括仓体及存储于仓体中的多个钉。在使用中,可将钉仓引入手术部位中并将其定位在所处理的组织的侧上。另外,可将钉成形砧座定位在组织的相对侧上。在各种实施例中,砧座可由第一钳口承载且钉仓可由第二钳口承载,其中第一钳口和/或第二钳口可朝另一钳口运动。一旦钉仓及砧座相对于组织定位,则可从钉仓体中射出钉,使得钉可刺穿组织并接触钉成形砧座。一旦从钉仓体中部署钉,则可从手术部位移除钉仓体。在本文所公开的各种实施例中,钉仓或钉仓的至少一部分中可植入有钉。在至少一个此类实施例中,如下文所更详细地描述,钉仓可包括仓体,当砧座从打开位置运动到闭合位置时,所述仓体可被所述砧座压缩、压溃和/或塌缩。当仓体被压缩、压溃和/或塌缩时,位于仓体中的钉可通过砧座而变形。作为另外一种选择,用于支撑钉仓的钳口可朝砧座运动至闭合位置。在两种情形的任一种中,在各种实施例中,当钉至少部分地位于仓体内时,钉可变形。在某些实施例中,钉可不从钉仓中被射出,而在一些实施例中,钉可与仓体的一部分一起从钉仓中被射出。
现在参见图18A-18D,可压缩钉仓(例如钉仓1000)例如可包括可压缩、植入式仓体1010,以及此外位于可压缩仓体1010中的多个钉1020,但图18A-18D仅示出一个钉1020。图18A示出由钉仓支撑件或钉仓通道1030支撑的钉仓1000,其中钉仓1000被示出处于未压缩状态。在此类未压缩状态中,砧座1040可接触或不接触组织T。在使用中,砧座1040可从打开位置运动至接触组织T,如图18B所示,以及将组织T抵靠仓体1010定位。即使砧座1040可将组织T定位成抵靠钉仓体1010的组织接触表面1019,然而再次参见图18B,钉仓体1010此时可受到极少的(如果有的话)压缩力或压力,并且钉1020可保持在未成形或未击发状态。如图18A和图18B所示,钉仓体1010可包括一个或多个层,并且钉1020的钉腿1021可穿过这些层向上延伸。在各种实施例中,仓体1010可包括第一层1011、第二层1012、第三层1013和第四层1014,其中第二层1012可被定位在第一层1011与第三层1013之间,其中第三层1013可被定位在第二层1012和第四层1014之间。在至少一个实施例中,例如钉1020的基部1022可被定位在第四层1014中的腔1015中,并且钉腿1021可从基部1022向上延伸并穿过第四层1014、第三层1013和第二层1012。在各种实施例中,每个可变形腿1021可包括末端,例如锋利的末端1023,例如当钉仓1000处于未压缩状态时,锋利的末端1023例如可被定位在第二层1012中。在至少一个此类实施例中,末端1023可不延伸至和/或穿过第一层1011,其中在至少一个实施例中,当钉仓1000处于未压缩状态时,末端1023可不突起穿过组织接触表面1019。在某些实施例中,当钉仓处于未压缩状态时,锋利的末端1023可被定位在第三层1013和/或任何其他合适的层中。在各种可供选择的实施例中,钉仓的仓体可具有任何合适数目的层,例如少于四层或多于四层。
在各种实施例中,如下文所更详细地描述,第一层1011可由支撑材料和/或塑性材料(例如聚对二氧环己酮(PDS)和/或聚乙醇酸(PGA))构成,并且第二层1012可由可生物吸收的泡沫材料和/或可压缩的止血材料(例如氧化再生纤维素(ORC))构成。在各种实施例中,第一层1011、第二层1012、第三层1013、和第四层1014中的一个或多个可将钉1020保持在钉仓体1010中,并且另外可使钉1020保持相互对齐。在各种实施例中,第三层1013可包含支撑材料或相当不可压缩的或非弹性材料,所述材料能够将钉1020的钉腿1021相对于彼此保持就位。此外,位于第三层1013的相对两侧上的第二层1012和第四层1014可稳定或减少钉1020的运动,即使第二层1012和第四层1014可包含可压缩的泡沫或弹性材料。在某些实施例中,钉腿1021的钉末端1023可至少部分地嵌入第一层1011中。在至少一个此类实施例中,第一层1011和第三层1013能够可协作地且稳固地将钉腿1021保持就位。在至少一个实施例中,第一层1011和第三层1013可分别包含可生物吸收材料(例如以商品名Vicryl出售的聚乙醇酸(PGA)、聚乳酸(PLA、PLLA)、聚对二氧环己酮(PDS)、聚羟基链烷酸酯(PHA)、以商品名Monocryl出售的聚卡普隆25(PGCL)、聚己内酯(PCL)、和/或PGA、PLA、PDS、PHA、PGCL、和/或PCL的复合物)形成的薄片,并且第二层1012和第四层1014可分别包含至少一种止血材料或止血剂。
尽管第一层1011可为可压缩的,然而第二层1012可基本上比第一层1011更可压缩。例如,第二层1012的可压缩性可为第一层1011的大约两倍、大约三倍、大约四倍、大约五倍和/或大约十倍。换句话讲,针对给定的力,第二层1012的压缩程度可为第一层1011的大约两倍、大约三倍、大约四倍、大约五倍、和/或大约十倍。在某些实施例中,第二层1012的可压缩性可在第一层1011的大约两倍与大约十倍之间。在至少一个实施例中,第二层1012中可限定有多个气隙,其中第二层1012中的气隙的量和/或尺寸可被控制以提供第二层1012的期望压缩。与上文相似,尽管第三层1013可为可压缩的,然而第四层1014能够比第三层1013基本上更具可压缩性。例如,第四层1014的可压缩性可为第三层1013的大约两倍、大约三倍、大约四倍、大约五倍、和/或大约十倍。换句话讲,针对给定的力,第四层1014的压缩程度可为第三层1013的大约两倍、大约三倍、大约四倍、大约五倍、和/或大约十倍。在某些实施例中,第四层1014的可压缩性可在第三层1013的大约两倍与大约十倍之间。在至少一个实施例中,第四层1014中可限定有多个气隙,其中第四层1014中的气隙的量和/或尺寸可被控制以便提供第四层1014的期望压缩。在各种情况下,可通过压缩率(即,层针对给定大小的力所压缩的距离)来表达仓体或仓体层的可压缩性。例如,与具有较低压缩率的层相比,具有高压缩率的层针对施加至该层的给定大小的压缩力将压缩更大的距离。如此而言,第二层1012可比第一层1011具有更高的压缩率;相似地,第四层1014可比第三层1013具有更高的压缩率。在各种实施例中,第二层1012和第四层1014可包含相同的材料并可具有相同的压缩率。在各种实施例中,第二层1012和第四层1014可包含具有不同压缩率的材料。相似地,第一层1011和第三层1013可包含相同的材料并可具有相同的压缩率。在某些实施例中,第一层1011和第三层1013可包含具有不同压缩率的材料。
当砧座1040朝其闭合位置行进时,砧座1040可接触组织T并对组织T和钉仓1000施加压缩力,如图18C所示。在这种情形中,砧座1040可朝钉仓支撑件1030向下推动仓体1010的顶部表面或组织接触表面1019。在各种实施例中,钉仓支撑件1030可包括仓支撑表面1031,当钉仓1000被压缩于仓支撑表面1031与砧座1040的组织接触表面1041之间时所述仓支撑表面1031能够支撑钉仓1000。由于砧座1040所施加的压力,仓体1010可被压缩且砧座1040可接触钉1020。更具体地,在各种实施例中,仓体1010的压缩和组织接触表面1019向下的运动可使钉腿1021的末端1023刺穿仓体1010的第一层1011、刺穿组织T、并进入砧座1040中的成形凹坑1042中。当仓体1010被砧座1040进一步压缩时,末端1023可接触限定成形凹坑1042的壁,并且因此例如腿1021可向内变形或卷曲,如图18C所示。当钉腿1021变形时,同样如图18C所示,钉1020的基部1022可接触钉仓支撑件1030或由钉仓支撑件1030支撑。在各种实施例中,如下文将更详细地描述,钉仓支撑件1030可包括多个支撑结构,例如钉支撑沟槽、狭槽、或槽1032,所述多个支撑结构能够当钉1020变形时支撑钉1020或至少钉1020的基部1022。同样如图18C所示,施加至钉仓体1010的压缩力可使第四层1014中的腔1015塌缩。除腔1015之外,钉仓体1010还可包括一个或多个空隙(例如空隙1016),例如所述一个或多个空隙中可定位有或未定位有钉的一部分,所述一个或多个空隙能够允许仓体1010塌缩。在各种实施例中,腔1015和/或空隙1016能够塌缩,以使限定腔和/或空隙的壁向下挠曲并接触仓支撑表面1031和/或接触仓体1010的位于腔和/或空隙下方的层。
在比较图18B和图18C时,显然,第二层1012及第四层1014被砧座1040所施加的压缩压力基本上压缩。也可注意,第一层1011和第三层1013也被压缩。当砧座1040运动至其闭合位置时,砧座1040可通过朝钉仓支撑件1030向下推动组织接触表面1019而继续进一步压缩仓体1010。当仓体1010被进一步压缩时,砧座1040可使钉1020变形至其完全成形形状,如图18D所示。参见图18D,每个钉1020的腿1021可朝每个钉1020的基部1022向下变形,以便将组织T、第一层1011、第二层1012、第三层1013和第四层1014的至少一部分捕获在可变形腿1021与基部1022之间。在比较图18C和图18D时,更显然,第二层1012和第四层1014进一步被砧座1040所施加的压缩压力显著压缩。在比较图18C和图18D时也可注意,第一层1011和第三层1013也被进一步压缩。在钉1020被完全或至少充分地成形之后,砧座1040可远离组织T而被抬起,并且钉仓支撑件1030可远离和/或脱离钉仓1000运动。如图18D所示并由于上文所述,仓体1010可植入有钉1020。在各种实施例中,被植入的仓体1010可沿钉行支撑组织。在某些情形中,被植入的仓体1010中容纳的止血剂和/或任何其他合适的治疗药物可随时间来处理组织。如上所述的止血剂可减少所缝合和/或所切割的组织出血,同时结合剂或组织粘合剂可随着时间的推移为组织提供强度。所植入的仓体1010可包含例如ORC(氧化再生纤维素)、蛋白基质、以商品名Vicryl出售的聚乙醇酸(PGA)、聚乳酸(PLA或PLLA)、聚对二氧环己酮(PDS)、聚羟基链烷酸酯(PHA)、以商品名Monocryl出售的聚卡普隆25(PGCL)、聚己内酯(PCL)、和/或PGA、PLA、PDS、PHA、PGCL、和/或PCL的复合物等材料。在某些情形中,仓体1010可包括能够减少手术部位感染的可能性的抗菌材料和/或抗微生物材料,例如胶体银和/或三氯生。
在各种实施例中,仓体1010的各层可相互连接。在至少一个实施例中,可利用至少一种粘合剂(例如纤维蛋白和/或蛋白水凝胶)将第二层1012粘附至第一层1011,将第三层1013粘附至第二层1012,并将第四层1014粘附至第三层1013。在某些实施例中,尽管未示出,然而仓体1010的各层可通过互锁机械结构连接在一起。在至少一个此类实施例中,第一层1011和第二层1012可各自包括对应的互锁结构,例如榫槽结构和/或燕尾榫结构。相似地,第二层1012和第三层1013可各自包括对应的互锁结构,同时第三层1013和第四层1014可各自包括对应的互锁结构。在某些实施例中,尽管未示出,然而钉仓1000可例如包括一个或多个铆钉,所述一个或多个铆钉可延伸穿过仓体1010的一个或多个层。在至少一个此类实施例中,每个铆钉可包括邻近第一层1011定位的第一端部或头部以及邻近第四层1014而定位的第二头部,所述第四层可被组装到铆钉的第二端部或由铆钉的第二端部形成。由于仓体1010的可压缩性质,在至少一个实施例中,例如铆钉可压缩仓体1010,以使铆钉的头部可相对于仓体1010的组织接触表面1019和/或底部表面1018凹陷。在至少一个此类实施例中,各铆钉可包含例如以商品名Vicryl出售的聚乙醇酸(PGA)、聚乳酸(PLA或PLLA)、聚对二氧环己酮(PDS)、聚羟基链烷酸酯(PHA)、以商品名Monocryl出售的聚卡普隆25(PGCL)、聚己内酯(PCL)、和/或PGA、PLA、PDS、PHA、PGCL、和/或PCL的复合物等可生物吸收的材料。在某些实施例中,除通过仓体1010中所容纳的钉1020之外,仓体1010的各层可不彼此连接。在至少一个此类实施例中,钉腿1021与仓体1010之间的摩擦接合例如可将仓体1010的各层保持在一起,并且一旦钉成形,则各层可被捕获在钉1020中。在某些实施例中,钉腿1021的至少一部分可包括能够增大钉1020与仓体1010之间的摩擦力的粗糙化表面或粗糙涂层。
如上所述,外科器械可包括第一钳口及第二钳口,第一钳口包括钉仓支撑件1030,第二钳口包括砧座1040。在各种实施例中,如下文所更详细描述,钉仓1000可包括一个或多个保持结构,所述一个或多个保持结构能够接合钉仓支撑件1030并因此将钉仓1000可释放地保持到钉仓支撑件1030。在某些实施例中,可通过至少一种粘合剂(例如,纤维蛋白和/或蛋白水凝胶)将钉仓1000粘附至钉仓支撑件1030。在使用中,在至少一种情形中,尤其是在腹腔镜式和/或内窥镜式手术中,例如第二钳口可运动至与第一钳口相对的闭合位置,使得第一钳口和第二钳口可通过套管针而被插入手术部位中。在至少一个此类实施例中,套管针可限定大约5mm的孔或插管,第一钳口和第二钳口可通过所述孔或插管而被插入。在某些实施例中,第二钳口可运动至处于打开位置与闭合位置之间的部分闭合位置,所述部分闭合位置可容许第一钳口和第二钳口穿过套管针被插入,而无需使钉仓体1010中所容纳的钉1020变形。在至少一个此类实施例中,当第二钳口处于其部分闭合的中间位置时,砧座1040可不对钉仓体1010施加压缩力,而在某些其他实施例中,当第二钳口处于其部分闭合的中间位置时,砧座1040可压缩钉仓体1010。尽管当砧座1040处于此类中间位置时可压缩钉仓体1010,然而砧座1040可不完全地压缩钉仓体1010,以使砧座1040接触钉1020和/或使得钉1020被砧座1040变形。一旦第一钳口和第二钳口通过套管针而被插入手术部位中,则第二钳口可被再次打开,并且砧座1040及钉仓1000可如上所述相对于靶组织进行定位。
现在参见图19A-19D,在各种实施例中,外科缝合器的端部执行器可包括位于砧座1140与钉仓支撑件1130之间的植入式钉仓1100。与上文相似,砧座1140可包括组织接触表面1141,钉仓1100可包括组织接触表面1119,并且钉仓支撑件1130可包括能够支撑钉仓1100的支撑表面1131。参见图19A,可利用砧座1140将组织T定位成使其抵靠钉仓1100的组织接触表面1119而不使钉仓1100变形,并且当砧座1140处于此类位置时,组织接触表面1141可被定位成与钉仓支撑表面1131相距距离1101a,并且组织接触表面1119可被定位成与钉仓支撑表面1131相距距离1102a。随后,当砧座1140朝钉仓支撑件1130运动时,现在参见图19B,砧座1140可向下推动钉仓1100的顶部表面或组织接触表面1119并压缩仓体1110的第一层1111和第二层1112。当层1111及层1112被压缩时,再次参见图19B,第二层1112可被压溃,并且钉1120的腿1121可刺穿第一层1111并进入组织T。在至少一个此类实施例中,钉1120可至少部分地定位在第二层1112中的钉腔或空隙1115中,并且当第二层1112被压缩时,钉腔1115可塌缩并因此容许第二层1112围绕钉1120而塌缩。在各种实施例中,第二层1112可包括覆盖部分1116,该覆盖部分可延伸于钉腔1115之上并围绕或至少部分地围绕钉腔1115。图19B示出了被向下压溃至钉腔1115中的覆盖分部1116。在某些实施例中,第二层1112可包括一个或多个弱化部分,所述一个或多个弱化部分可有利于第二层1112的塌缩。在各种实施例中,此类弱化部分可包括例如能够有利于仓体1110进行可控塌缩的划痕、穿孔、和/或薄的横截面。在至少一个实施例中,第一层1111可包括能够有利于钉腿1121穿透第一层1111的一个或多个弱化部分。在各种实施例中,此类弱化部分可包括例如能够与钉腿1121对齐或至少基本上对齐的划痕、穿孔、和/或薄的横截面。
再次参见图19A,当砧座1140处于部分闭合的未击发位置时,砧座1140可被定位成与仓支撑表面1131相距距离1101a,使得其间限定有间隙。此间隙可由具有钉仓高度1102a的钉仓1100及组织T填充。当砧座1140向下运动以压缩钉仓1100时,再次参见图19B,组织接触表面1141与仓支撑表面1131之间的距离可由短于距离1101a的距离1101b限定。在各种情况下,砧座1140的组织接触表面1141与仓支撑表面1131之间的由距离1101b限定的间隙可大于原始的未变形的钉仓高度1102a。现在参见图19C,当砧座1140运动至更靠近仓支撑表面1131时,第二层1112可继续塌缩且钉腿1121与成形凹坑1142之间的距离可减小。相似地,组织接触表面1141与仓支撑表面1131之间的距离可减小至距离1101c,在各种实施例中,距离1101c可大于、等于、或小于原始的未变形仓高度1102a。现在参见图19D,砧座1140可运动至最终的击发位置,在最终的击发位置中,钉1120完全成形或至少成形至期望高度。在此类位置中,砧座1140的组织接触表面1141可与仓支撑表面1131相距距离1101d,其中距离1101d可短于原始的未变形仓高度1102a。同样如图19D所示,钉腔1115可完全或至少基本上塌缩,并且钉1120可完全或至少基本上被塌缩的第二层1112围绕。在各种情况下,砧座1140可随后远离钉仓1100运动。一旦砧座1140与钉仓1100脱离,则仓体1110可例如至少部分地再次伸展于各种位置(即,相邻的钉1120之间的位置)中。在至少一个实施例中,压溃的仓体1110可能不以弹性方式再次伸展。在各种实施例中,成形的钉1120及另外位于相邻的钉1120之间的仓体1110可对组织T施加压力或压缩力,这可提供各种有益的治疗效果。
如上所述,再次参见图19A所示的实施例,每个钉1120可包括从其延伸的钉腿1121。尽管钉1120被绘示为包括两个钉腿1121,然而也可利用可包括一个钉腿或作为另一选择包括超过两个钉腿(例如三个钉腿或四个钉腿)的各种钉。如图19A所示,每个钉腿1121均可嵌入仓体1110的第二层1112中,使得钉1120固定于第二层1112中。在各种实施例中,钉1120可被插入仓体1110的钉腔1115中,使得钉腿1121的末端1123在基部1122之前进入腔1115中。在各种实施例中,在末端1123被插入腔1115之后,末端1123可被按压至覆盖部分1116中并切割第二层1112。在各种实施例中,钉1120可被密封至第二层1112中的足够深度处,使得钉1120相对于第二层1112不运动或至少基本上不运动。在某些实施例中,钉1120可被密封至第二层1112中的足够深度处,使得基部1122被定位或嵌入钉腔1115中。在各种其他实施例中,基部1122可不被定位或嵌入第二层1112中。再次参见图19A,在某些实施例中,基部1122可在仓体1110的底部表面1118下方延伸。在某些实施例中,基部1122可承靠于仓支撑表面1130上或直接抵靠仓支撑表面1130定位。在各种实施例中,仓支撑表面1130可包括从其延伸和/或限定在其中的支撑结构,其中在至少一个此类实施例中,钉1120的基部1122可被定位在例如钉仓支撑件1130中的一个或多个支撑沟槽、狭槽、或槽1132中或由所述一个或多个支撑沟槽、狭槽、或槽1132支撑,如下文将更详细地描述。
对上文进行进一步描述,现在参见图20,钉1120的基部1122可直接抵靠钉仓支撑件1130的支撑表面1131而定位。在各种实施例中,包括如下实施例:其中钉基部1122包括圆形或弓形底部表面1124,例如钉基部1122可沿钉仓支撑表面1131运动或滑动。当砧座1140在钉成形过程期间被压抵钉腿1121的末端1123时会发生此类滑动。在某些实施例中,如上所述且现在参见图21,钉仓支撑件1130中可包括一个或多个支撑狭槽1132,所述一个或多个支撑狭槽能够消除或至少减少钉基部1122与仓支撑表面1131之间的相对运动。在至少一个此类实施例中,每个支撑狭槽1132均可由表面轮廓限定,所述表面轮廓与位于支撑狭槽1132中的钉底部表面的轮廓相匹配或至少基本上相匹配。例如,图21所示的基部1122的底部表面1124可包括圆形或至少基本上圆形的表面,并且支撑狭槽1132也可包括圆形或至少基本上圆形的表面。在至少一个此类实施例中,用于限定狭槽1132的表面可由大于或等于限定底部表面1124的曲率半径的曲率半径限定。尽管狭槽1132可有助于防止或减少钉1120与钉仓支撑件1130之间的相对滑动运动,然而狭槽1132也能够防止或减少钉1120与钉仓支撑件1130之间的相对旋转运动。更具体地,在至少一个实施例中,狭槽1132能够紧密地容纳基部1122,以便防止或减少钉1120围绕轴线1129的旋转,例如以使钉1120在变形时不会旋转或扭曲。
在各种实施例中,对上文进行进一步描述,每个钉1120均可由圆的或至少基本上圆的线材形成。在某些实施例中,每个钉的腿及基部均可由具有非圆形横截面(例如矩形横截面)的线材形成。在至少一个此类实施例中,钉仓支撑件1130可包括对应的非圆形狭槽(例如矩形狭槽),所述非圆形狭槽能够容纳此类钉的基部。现在参见图22,在各种实施例中,每个钉1120均可包括重叠注塑至基部1122上的冠部诸如冠部1125,其中每个冠部1125均可被定位在钉仓支撑件1130中的支撑狭槽内。在至少一个此类实施例中,每个冠部1125均可包括例如正方形和/或矩形的横截面,所述横截面能够容纳在例如钉仓支撑件1130中的正方形和/或矩形的狭槽1134内。在各种实施例中,冠部1125可包含可生物吸收的塑料(例如以商品名Vicryl出售的聚乙醇酸(PGA)、聚乳酸(PLA或PLLA)、聚对二氧环己酮(PDS)、聚羟基链烷酸酯(PHA)、以商品名Monocryl出售的聚卡普隆25(PGCL)、聚己内酯(PCL)、和/或PGA、PLA、PDS、PHA、PGCL、和/或PCL的复合物),并可通过例如注塑方法围绕钉1120的基部1122形成。各种冠部及用于形成各种冠部的方法公开于2006年9月29日提交的名称为“SURGICAL STAPLES HAVING COMPRESSIBLEOR CRUSHABLE MEMBERS FOR SECURING TISSUE THEREIN ANDSTAPLING INSTRUMENTS FOR DEPLOYING THE SAME”的美国专利申请序列号11/541,123中。再次参见图22,狭槽1134还可包括导入部或斜角1135,该导入部或斜角能够有利于将冠部1125插入狭槽1134中。在各种实施例中,当钉仓1100被组装至钉仓支撑件1130时,钉1120的基部和/或冠部可被定位在狭槽1134内。在某些实施例中,当钉仓1100被组装至钉仓支撑件1130时,钉1120的冠部1125可与狭槽1134对齐。在至少一个此类实施例中,冠部1125可不进入狭槽1134中,直至对钉腿1121施加压缩力且钉1120的基部和/或冠部被向下推动至狭槽1134中。
现在参见图23和图24,在各种实施例中,钉仓诸如钉仓1200例如可包括可压缩植入式仓体1210,该仓体包括外层1211及内层1212。与上文相似,钉仓1200可包括位于仓体1210内的多个钉1220。在各种实施例中,每个钉1220均可包括基部1222以及从基部延伸的一个或多个钉腿1221。在至少一个此类实施例中,钉腿1221可插入内层1212中并被密封至例如使钉1220的基部1222邻接和/或邻近内层1212的底部表面1218定位。在图23和图24所示的实施例中,内层1212不包括能够容纳钉1220的一部分的钉腔,而在其他实施例中,内层1212可包括此类钉腔。在各种实施例中,对上文进行进一步描述,内层1212可包含能够容许仓体1210在对其施加压缩负载时塌缩的可压缩材料(例如可生物吸收的泡沫和/或氧化再生纤维素(ORC))。在各种实施例中,内层1212可包含例如包含聚乳酸(PLA)和/或聚乙醇酸(PGA)的冻干泡沫。ORC可以商品名Surgicel商购获得并可包括松散的织造物(类似外科用海绵)、散纤维(类似棉球)和/或泡沫。在至少一个实施例中,内层1212可由其中包含和/或上面涂覆有药物(例如冷冻干燥的凝血酶和/或纤维蛋白)的材料构成,所述药物例如可被患者体内的流体水活化和/或活化。在至少一个此类实施例中,冷冻干燥的凝血酶和/或纤维蛋白可保持在例如Vicryl(PGA)基质上。然而,在某些情形中,例如当钉仓1200插入患者体内的手术部位中时,可活化的药物可被无意地活化。再次参见图23和图24,在各种实施例中,外层1211可由水不可渗透的或至少基本上水不可渗透的材料构成,以使液体不接触或至少基本上不接触内层1212,直至仓体1210被压缩且钉腿穿透外层1211之后和/或外层1211以某种方式被切开之后。在各种实施例中,外层1211可包含支撑材料和/或塑性材料(例如聚对二氧环己酮(PDS)和/或聚乙醇酸(PGA))。在某些实施例中,外层1211可包括环绕内层1212及钉1220的包裹物。更具体地,在至少一个实施例中,钉1220可被插入内层1212及外层1211中并围绕包括内层1212和钉1220的子组件而被包裹并随后被密封。
现在参见图25和图26,在各种实施例中,钉仓诸如钉仓1300例如可包括可压缩植入式仓体1310,该仓体包括外层1311及内层1312。与上文相似,钉仓1300还可包括位于仓体1310内的钉1320,其中每个钉1320均可包括基部1322以及从基部1322延伸的一个或多个腿1321。类似于钉仓1200,钉1320的基部1322可在内层1312的底部表面1318下方延伸,并且外层1311可围绕基部1322。在至少一个此类实施例中,外层1311可具有足够的柔性来包围每个钉基部1322,使得外层1311适形于基部1322的轮廓。再次参见图24,在至少一个可供选择的实施例中,外层1211可具有足够的刚性,使得其围绕基部1222延伸而不适形于每个基部1222。在任何情形中,在各种实施例中,外层1311可被定位在钉1320的基部1322与用于支撑钉仓1300的钉仓支撑表面(例如支撑表面1031或1131)之间。在至少一个此类实施例中,外层1311可被定位在基部1322与限定在钉仓支撑表面中的支撑狭槽(例如狭槽1032或1132)之间。在至少一个此类实施例中,对上文进行进一步描述,外层1311能够限制基部1322的运动和/或增大基部1322与钉仓支撑表面和/或支撑狭槽之间的摩擦系数以便减少其间的相对运动。现在参见图27和图28,在各种可供选择的实施例中,钉仓诸如钉仓1400的外层可不完全地围绕位于其中的钉。在至少一个此类实施例中,在钉1420的钉腿1421插入仓体1410中之前,可压缩植入式仓体1410的外层1411可被组装至内层1412。由于上文所述,钉1420的基部1422可延伸于外层1411的外面,并且在至少一个此类实施例中,例如基部1422可直接定位在钉仓支撑表面1031或1131内的支撑狭槽1032或1132中。在各种实施例中,当钉腿1421插入穿过外层1411时,钉腿1421可切开外层1411。在各种情况下,由钉腿1421形成的孔可紧密地围绕钉腿1421,使得钉腿1421与外层1411之间泄漏极少(如果存在的话)的流体,这能够减少或防止钉仓体1410中容纳的药物被过早地活化和/或泄漏出仓体1410的可能性。
如上所述,再次参见图23和图24,钉1220的腿1221可嵌入仓体1210内,并且钉1220的基部1222可自内层1212的底部表面1218向外延伸。在各种实施例中,对上文进行进一步描述,内层1212可不包括能够容纳钉1220的钉腔。现在参见图29和图30,在各种其他实施例中,钉仓诸如钉仓1500例如可包括可压缩植入式仓体1510,该仓体包括能够在其中容纳钉1520的至少一部分的钉腔1515。在至少一个此类实施例中,钉1520的钉腿1521的顶部可嵌入内层1512中,而钉腿1521的底部和基部1522可被定位在钉腔1515内。在某些实施例中,基部1522可完全定位在钉腔1515中,而在一些实施例中,基部1522可至少部分地在内层1512的底部表面1518下方延伸。与上文相似,外层1511可围绕内层1512和位于内层1512中的钉1520。现在参见图31,在某些其他实施例中,钉仓1600可包括位于可压缩植入式仓体1610中的钉腔1615内的钉1620,其中钉1620的至少一部分未被外层1611包围。在至少一个此类实施例中,每个钉1620均可包括至少部分地嵌入内层1612中的钉腿1621以及围绕外层1611向外延伸的基部1622。
现在参见图32和图33,在各种实施例中,钉仓诸如钉仓1700例如可包括可压缩植入式仓体1710以及至少部分地位于仓体1710内的多个钉1720。仓体1710可包括外层1711、内层1712、和对齐矩阵1740,该对齐矩阵能够将钉1720对齐和/或在仓体1710内保持就位。在至少一个实施例中,内层1712可包括能够在其中容纳对齐矩阵1740的凹陷部1741。在各种实施例中,对齐矩阵1140可压配于凹陷部1741内和/或换句话讲利用至少一种粘合剂(例如,纤维蛋白和/或蛋白水凝胶)恰当地固定至内层1712。在至少一个实施例中,凹陷部1741能够使得对齐矩阵1740的底部表面1742与内层1712的底部表面1718对齐或至少基本上对齐。在某些实施例中,对齐矩阵的底部表面1742可相对于第二层1712的底部表面1718凹陷和/或从底部表面1718延伸。在各种实施例中,每个钉1720均可包括基部1722以及从基部1722延伸的一个或多个腿1721,其中钉腿1721的至少一部分可延伸穿过对齐矩阵1740。对齐矩阵1740还可包括例如延伸穿过其中的多个孔和/或狭槽,所述多个孔和/或狭槽能够在其中容纳钉腿1721。在至少一个此类实施例中,每个孔均能够紧密地容纳钉腿1721,使得钉腿1721与孔的侧壁之间发生很小的(如果有的话)相对运动。在某些实施例中,对齐矩阵孔可不完全延伸穿过对齐矩阵1740,并且当钉腿1721被推动穿过对齐矩阵1740时,钉腿1721可需要切开对齐矩阵1740。
在某些实施例中,对齐矩阵1740可由模制的塑性主体构成,在至少一个实施例中,所述模制的塑性主体可比内层1712和/或外层1711更硬或可压缩性更低。在至少一个此类实施例中,对齐矩阵1740可包含塑性材料和/或任何其他合适的材料(例如聚对二氧环己酮(PDS)和/或聚乙醇酸(PGA))。在某些实施例中,对齐矩阵1740可组装至内层1712,并且随后钉腿1721可插入穿过对齐矩阵1740并嵌入内层1712中。在各种实施例中,对齐矩阵1740的底部表面1742可包括能够至少部分地容纳钉1720的基部1722的一个或多个沟槽、狭槽、或槽。与上文相似,外层1711可放置在包括内层1712、对齐矩阵1740、和钉1720的子组件的周围。作为另外一种选择,外层1711可放置在包括内层1712及对齐矩阵1740的子组件的周围,其中钉1720可随后插入穿过外层1711、对齐矩阵1740、和内层1712。在任一情形中,由于上文所述,内层1712、对齐矩阵1740、和/或外层1711能够将钉1720保持就位,直到砧座如上所述使钉1720变形,和/或在砧座如上所述使钉1720变形之后,内层1712、对齐矩阵1740、和/或外层1711能够将钉1720保持就位。在至少一个此类实施例中,对齐矩阵1740可用于在钉仓1700被植入患者体内之前将钉1720保持就位,以及在钉仓1700被植入之后沿钉行固定组织。在至少一个实施例中,例如钉1720可被固定在对齐矩阵1740内而不嵌入内层1712和/或外层1711中。
现在参见图34-40,在各种实施例中,可通过压缩内层1812、将钉诸如钉1820插入内层1812中、并用外层1811包裹内层1812来组装钉仓诸如钉仓1800。首先参见图34,可压缩的内层1812被示为包括限定在其中的多个钉腔1815,然而也可设想出如上所述其中内层1812不包括钉腔的其他实施例。现在参见图35,可压缩的内层1812可被定位在传送板1850与支撑板1860之间并被分别压缩于传送板1850的压缩表面1852与支撑板1860的压缩表面1862之间。如图35所示,内层1812的顶部表面及底部表面可朝向彼此压缩,并且响应于此,内层1812可沿侧向向外膨胀。在某些实施例中,内层1812可被压缩至例如其原始高度的大约三分之一的高度处,并且在其压缩状态中可具有例如大约0.06"至大约0.08"之间的高度或厚度。同样如图35所示,传送板1850还可包括例如位于多个钉井1853内的多个钉诸如钉1820。另外,传送板1850还可包括多个驱动器1851,所述多个驱动器能够将钉1820向上推出钉井1853外。现在参见图36,可利用驱动器1851将钉1820的钉腿1821推入压缩的内层1812中并使其穿过压缩的内层1812。在各种实施例中,驱动器1851能够使得当钉1820从传送板1850的钉井1853中被完全部署时,驱动器1851的顶部表面被定位成与传送板1850的压缩表面1852齐平或至少几乎齐平。在某些实施例中,同样如图36所示,支撑板1860可包括多个容纳孔1861,所述多个容纳孔1861能够在钉腿1821被推动穿过内层1812之后容纳钉腿1821或至少钉腿1821的末端。在其中内层1812已被压缩至短于钉1820高度的高度处的实施例中,容纳孔1861或类似结构可为必需的,因此当钉1820从钉井1853中被完全射出时,钉腿1821可从压缩的内层1812的顶部表面突起。在某些其他实施例中,内层1812可被压缩至高于钉1820高度的高度处,因此不需要支撑板1860中的容纳孔1861。
现在参见图37,在钉1820被插入内层1812中之后,支撑板1860可远离传送板1850运动,以便容许内层1812减压。在这种情形中,内层1812可以弹性方式再次伸展至其原始的未压缩高度或至少接近原始的未压缩高度。当内层1812再次伸展时,内层1812的高度可增大至超过钉1820的高度且钉1820的钉腿1821不再从内层1812的顶部表面突起。在各种情况下,容纳孔1861能够将钉腿1821保持就位,至少直到支撑板1860已运动至足够远而使腿1821不再位于容纳孔1861内。在这种情形中,容纳孔1861可在内层1812再次伸展时有助于内层1812内的钉1820保持相对对齐。在各种情况下,内层1812及位于其中的钉1820可包括子组件1801,现在参见图38,子组件1801可例如被插入外层1811中。在至少一个此类实施例中,外层1811可包括限定在其中的腔体1802,所述腔体能够在其中容纳子组件1801。在各种情况下,可利用工具例如镊子1855将外层1811牵拉至子组件1801上。现在参见图39,一旦子组件1801完全位于外层1811内,则外层1811可被密封。在各种实施例中,可利用向外层1811的一部分施加热能来密封外层1811。更具体地,在至少一个实施例中,外层1811可包含塑性材料,其中外层1811的开口端可由一种或多种被加热的元素或铁1856热熔,以便将外层1811的开口端的周边结合和/或密封在一起。现在参见图40,在至少一个此类实施例中,外层1811的多余部分1857可被移除,并且随后可如本文所述来使用钉仓1800。
如上所述,钉仓可位于钉仓附接部中和/或固定到钉仓附接部。现在参见图41和图42,在各种实施例中,钉仓附接部可包括钉仓通道诸如钉仓通道1930,该钉仓通道例如能够在其中容纳钉仓诸如钉仓1900的至少一部分。在至少一个实施例中,钉仓通道1930可包括底部支撑表面1931、第一侧向支撑壁1940和第二侧向支撑壁1941。在使用中,钉仓1900可被定位在钉仓通道1930内,使得钉仓1900抵靠和/或邻近底部支撑表面1931定位,并位于第一侧向支撑壁1940与第二侧向支撑壁1941之间。在某些实施例中,第一侧向支撑壁1940与第二侧向支撑壁1941之间可限定有侧向间隙。在至少一个此类实施例中,钉仓1900可包括侧向宽度1903,该侧向宽度和支撑壁1940与1941之间所限定的侧向间隙的宽度相同和/或宽于支撑壁1940与1941之间所限定的侧向间隙,使得钉仓1900的可压缩植入式仓体1910可牢固地配合于壁1940与1941之间。在某些其他实施例中,钉仓1900的侧向宽度1903可短于第一侧壁1940与第二侧壁1941之间所限定的间隙。在各种实施例中,壁1940和1941以及底部支撑表面1931的至少一部分可由冲压的金属通道限定,而在至少一个实施例中,侧向支撑壁1940和/或侧向支撑壁1941的至少一部分可包含柔性材料(例如弹性体材料)。首先参见图41,钉仓通道1930的第一侧壁1940和第二侧壁1941均可由从底部支撑表面1931向上延伸的刚性部分1933以及从刚性部分1933向上延伸的柔性部分1934构成。
在各种实施例中,对上文进行进一步描述,钉仓1900的仓体1910可由一个或多个可压缩的层例如第一层1911和第二层1912构成。当仓体1910被砧座以上述方式压缩抵靠底部支撑表面1931时,仓体1910的侧部可侧向地伸展。在其中钉仓1930由刚性侧壁构成的实施例中,刚性侧壁可防止或至少限制仓体1910的侧向伸展,因此仓体1910内可产生显著量的内部压力或应力。在钉仓1930的至少一部分由柔性侧壁构成的实施例中,柔性侧壁能够侧向地挠曲并容许仓体1910的侧部侧向伸展,从而减小仓体1910内所产生的内部压力或应力。在仓通道不包括侧壁或所包括的侧壁相对地短于钉仓的实施例中,钉仓的侧部可不受抑制地或至少基本上不受抑制地沿侧向伸展。现在参见图42,在任何情形中,钉仓通道2030可包括侧壁2040和2041,该侧壁可完全包含柔性材料,诸如弹性体材料。钉仓通道2030还可包括沿钉仓通道2030的底部支撑表面2031的边延伸的侧向狭槽2033,该侧向狭槽能够在其中容纳并固定侧壁2040和2041的至少一部分。在某些实施例中,侧壁2040和2041可经由搭扣配合和/或压配结构而固定在狭槽2033中,而在至少一些实施例中,侧壁2040和2041可通过一种或多种粘合剂固定在狭槽2033中。在至少一个实施例中,侧壁2040和2041可在使用期间与底部支撑表面2031分离。在任何情形中,当仓体2010中植入有钉2020时,可压缩植入式仓体2010可与侧壁2040和2041分离和/或脱离。
现在参见图43,在各种实施例中,外科器械可包括轴2150以及从轴2150的远端延伸的端部执行器。与上文相似,端部执行器可包括钉仓通道2130、可在打开位置与闭合位置之间运动的砧座2140、以及位于钉仓通道2130与砧座2140之间的钉仓2100。同样类似于上文,钉仓2100可包括可压缩植入式仓体2110以及位于仓体2110中的多个钉2120。在各种实施例中,钉仓通道2130可包括底部支撑表面2131、远端2135和近端2136,钉仓2100可抵靠底部支撑表面2131而定位。在至少一个实施例中,如图43所示,钉仓2100可包括第一端部2105和第二端部2106,所述第一端部2105可被定位在钉仓通道2130的远端2135中,所述第二端部2106可被定位在钉仓通道2130的近端2136中。在各种实施例中,钉仓通道2130的远端2135可包括至少一个远侧保持结构(例如保持壁2137);相似地,近端2136可包括至少一个近侧保持结构(例如保持壁2138)。在至少一个此类实施例中,远侧保持壁2137与近侧保持壁2138之间可限定有缝隙,所述缝隙可等于或小于钉仓2100的长度,使得当钉仓2100被插入钉仓通道2130中时,钉仓2100可牢固地配合于钉仓通道2130内。
再次参见图23和图24,在各种实施例中,钉仓诸如钉仓1200例如可包括平的或至少基本上平的组织接触表面1219。在至少一个此类实施例中,钉仓1200的钉仓体1210可包括第一端部1205和第二端部1206,所述第一端部可由第一高度或厚度1207限定,所述第二端部1206可由第二高度或厚度限定,其中第一高度1207可等于或至少基本上等于第二高度1208。在某些实施例中,仓体1210可在第一端部1205与第二端部1206之间包括恒定的或至少基本上恒定的高度或厚度。在至少一个此类实施例中,组织接触表面1219可平行或至少基本上平行于仓体1210的底部表面1218。再次参见图43,在各种实施例中,钉仓2100的仓体2110的第一端部2105可由第一高度2107限定,该第一高度不同于第二端部2106的第二高度2108。在所示实施例中,第一高度2107大于第二高度2108,然而在可供选择的实施例中,第二高度2108可大于第一高度2107。在各种实施例中,仓体2110的高度可在第一端部2105与第二端部2106之间线性地和/或几何地减小。在至少一个此类实施例中,在第一端部2105与第二端部2106之间延伸的组织接触表面2119可沿第一端部2105与第二端部2106之间限定的角度进行取向。在至少一个此类实施例中,组织接触表面2119可不平行于仓体2110的底部表面2118和/或不平行于钉仓通道2130的支撑表面2131。
再次参见图43和图44,在各种实施例中,砧座2140可包括组织接触表面2141,当砧座2140处于闭合位置时,组织接触表面2141可平行于或至少基本上平行于钉仓通道2130的支撑表面2131,如图44所示。当砧座2140处于闭合位置时,砧座2140对钉仓2100的第一端部2105的压缩程度可大于第二端部2106,这是因为第一端部2105的高度较高,而第二端部2106的高度较低。在一些情形中,包括其中位于组织接触表面2119与2141之间的组织T具有恒定的或至少基本上恒定的厚度的情形,组织T及仓2100中在端部执行器的远端处所产生的压力可大于在端部执行器的近端处所产生的压力。更具体地,当砧座2140与钉仓2100之间的组织T具有基本上恒定的厚度时,位于砧座2140的远端2145与钉仓2100的第一端部2105之间的组织T被压缩的程度可大于位于砧座2140的近端2146与钉仓2100的第二端部2106之间的组织T。在各种实施例中,端部执行器的近端与远端之间的组织T中可产生压力梯度。更具体地,在至少一个实施例中,当砧座2140与钉仓2100之间的组织T具有基本上恒定的厚度且钉仓2100的高度从端部执行器的远端到近端线性地减小时,组织T中的压力可从端部执行器的远端到端部执行器的近端线性地减小。相似地,在至少一个实施例中,当砧座2140与钉仓2100之间的组织T具有基本上恒定的厚度且钉仓2100的高度从端部执行器的远端到近端几何地减小时,组织T中的压力可从端部执行器的远端到端部执行器的近端几何地减小。
再次参见图43,在各种实施例中,位于钉仓2100与砧座2140之间的组织T可不具有自始至终恒定的厚度。在至少一个这种情形中,位于砧座2140的近端2146与钉仓2100的第二端部2106之间的组织T可厚于位于砧座2140的远端2145与钉仓2100的第一端部2105之间的组织T。因此,在这种情形中,较厚的组织T可通常位于钉仓2100的较低的近端2106上方,并且较薄的组织T可通常位于较高的远端2105上方。在使用中,轴2150的击发衬圈2152可沿轴脊2151朝远侧推进,使得击发衬圈2152接合砧座2140的凸轮部分2143,并使砧座2140朝钉仓2100旋转,如图44所示。一旦砧座2140旋转至完全闭合的位置,则组织T可被压缩于组织接触表面2119与2141之间,并且尽管钉仓2100的高度可在端部执行器的近端与远端之间不恒定,然而施加至组织T的压力或压缩力在组织T中可为恒定的或至少基本上恒定的。更具体地,当较薄的组织T可与钉仓2100的较高的高度相关,并且较厚的组织T可与钉仓2100的较低的高度相关时,组织T及钉仓2100的累加高度或高度之和可在端部执行器的近端与远端之间为恒定的或至少基本上恒定的,因此砧座2140对此累加高度的压缩在累加高度中可为恒定的或至少基本上恒定的。
再次参见图43和图44,在各种实施例中,钉仓2100可包括非对称构型。在至少一个此类实施例中,例如钉仓2100在其第一端部2105处的高度可高于钉仓2100在其第二端部2106处的高度。在某些实施例中,钉仓2100和/或钉仓通道2130可包括一个或多个对齐和/或保持结构,所述一个或多个对齐和/或保持结构能够确保钉仓2100仅沿一个方向(即,其中第一端部2105位于钉仓通道2130的远端2135中且第二端部2106位于近端2136中的方向)定位在钉仓通道2130内。在各种可供选择的实施例中,钉仓2100和/或钉仓通道2130可包括一个或多个对齐和/或保持结构,所述一个或多个对齐和/或保持结构能够容许钉仓2100沿不止一个方向定位在钉仓通道2130内。现在参见图45,例如钉仓2100可被定位在钉仓通道2130内,以使钉仓2100的第一端部2105可被定位在钉仓通道2130的近端2136中且第二端部2106可被定位在远端2135中。因此,在各种实施例中,较低高度的钉仓2100可邻近远侧保持壁2137定位,而较高高度的钉仓2100可邻近近侧保持壁2138定位。在至少一个此类实施例中,钉仓2100可被恰当地设置以向在端部执行器的远端内具有较厚部分而在端部执行器的近端内具有较薄部分的组织T施加恒定的或至少基本上恒定的夹紧压力。在各种实施例中,钉仓2100例如可在钉仓通道2130内选择性地取向。在至少一个此类实施例中,钉仓2100的对齐和/或保持结构可为对称的,并且外科医生可沿例如图43和图45所示的方向在钉仓通道2130内对钉仓2100进行选择性取向。
对上文进行进一步描述,植入式仓体2110可包括纵向轴线2109,当钉仓2100被定位在钉仓通道2130中时,纵向轴线2109可在端部执行器的近端与远端之间延伸。在各种实施例中,仓体2110的厚度可在第一端部2105与第二端部2106之间沿纵向轴线2109大致减小和/或大致增大。在至少一个此类实施例中,底部表面2118与组织接触表面2119之间的距离或高度可在第一端部2105与第二端部2106之间大致减小和/或大致增大。在某些实施例中,仓体2110的厚度沿纵向轴线2109既可增大也可减小。在至少一个此类实施例中,仓体2110的厚度可包括在厚度上增大的一个或多个部分以及在厚度上可减小的一个或多个部分。在各种实施例中,钉仓2100可包括定位在其中的多个钉2120。在使用中,如上所述,当砧座2140运动至闭合位置时,钉2120可变形。在某些实施例中,每个钉2120可具有相同的或至少基本上相同的高度。在至少一个此类实施例中,可例如从钉基部的底部到钉最高腿的顶部或末端来测量钉的高度。
在各种实施例中,钉仓内的钉可具有不同的钉高度。在至少一个此类实施例中,钉仓可包括具有第一钉高度的第一组钉和具有第二钉高度的第二组钉,所述第一组钉定位在可压缩仓体的第一部分中,并且第二组钉被定位在可压缩仓体的第二部分中。在至少一个实施例中,第一钉高度可高于第二钉高度,并且第一组钉可被定位在钉仓2100的第一端部2105中,而第二组钉可被定位在第二端部2106中。作为另外一种选择,较高的第一组钉可被定位在钉仓2100的第二端部2106中,而较低的第二组钉可被定位在第一端部2105中。在某些实施例中,可利用多个钉组,其中每个组各自具有不同的钉高度。在至少一个此类实施例中,具有中间钉高度的第三组可在第一组钉与第二组钉之间被定位在仓体2110中。在各种实施例中,钉仓中的钉排内的每个钉可各自包括不同的钉高度。在至少一个实施例中,钉排内的最高钉可定位在钉排的第一端部上,并且最低的钉可定位在该钉排的相对端上。在至少一个此类实施例中,位于最高钉与最低钉之间的钉可设置成使得钉高度例如在最高钉与最低钉之间下降。
现在参见图46,在各种实施例中,外科缝合器的端部执行器可包括砧座2240、钉仓通道2230、以及由钉仓通道2230支撑的钉仓2200。钉仓2200可包括可压缩植入式仓体2210以及被定位在仓体2210中的多个钉,诸如钉2220a和钉2220b。在各种实施例中,钉仓通道2230可包括仓支撑表面2231以及限定在仓支撑表面2231中的多个钉支撑狭槽,诸如支撑狭槽2232a和2232b。在至少一个此类实施例中,钉仓2200可包括两个外侧钉2220a排和两个外侧钉2220b排,其中支撑狭槽2232a能够支撑钉2220a,并且支撑狭槽2232b能够支撑钉2220b。参见图46和图47,砧座2240可包括限定在其中的多个钉成形凹坑2242,当砧座2240朝钉仓2200运动时,所述多个钉成形凹坑2242能够容纳钉2220a和2220b并使其变形。在至少一个此类实施例中,支撑狭槽2232a的底部表面可与钉成形凹坑2242的顶部表面相距第一距离2201a,而支撑狭槽2232b的底部表面可与钉成形凹坑2242的顶部表面相距第二距离2201b。在至少一个此类实施例中,由于其中限定有支撑狭槽2232b的支撑表面2231中具有升高的台阶,因此支撑狭槽2232b更靠近砧座2240定位。由于具有不同的距离2201a和2201b,因此在各种实施例中,外侧钉2220a排和内侧钉2220b排可变形至不同的成形高度。在各种情况下,变形至不同成形高度的钉可对所缝合的组织T施加不同的夹紧压力或夹紧力。除上文所述之外,钉可在起初具有不同的未成形钉高度。再次参见图46,在至少一个此类实施例中,外层钉2220a的初始未成形高度可大于内侧钉2220b的初始未成形高度。如图46和图47所示,未成形高度低于外侧钉2220a的内侧钉2220b也可具有低于外侧钉2220b的成形高度。在各种可供选择的实施例中,内侧钉2220b可具有比外侧钉2220a高的未成形高度而具有比外侧钉2220a低的变形钉高度。
在各种实施例中,对上文进行进一步描述,砧座2240可运动到闭合位置中,如图47所示,以便压缩仓体2210并使钉2220a及2220b变形。在某些实施例中,包括图46和图47所示端部执行器的外科缝合器例如还可包括切割构件,所述切割构件能够横切位于砧座2240与钉仓2200之间的组织T。在至少一个此类实施例中,砧座2240、钉仓通道2230和/或钉仓2200可限定狭槽,所述狭槽能够在其中可滑动地容纳切割构件。更具体地,砧座2240可包括狭槽部分2249,钉仓通道2230可包括狭槽部分2239,并且钉仓2200可包括狭槽部分2203,当砧座2240处于闭合位置或至少基本上闭合的位置时,狭槽部分2249、狭槽部分2239、和狭槽部分2203可相互对齐或至少基本上对齐。在各种实施例中,在砧座2240闭合且钉2220a、2220b变形之后,切割构件可从端部执行器的近端朝端部执行器的远端运动。在至少一个实施例中,切割构件能够以与钉变形过程不相关的方式运动。在某些实施例中,切割构件可在钉变形的同时被推进。在任何情形中,在至少一个实施例中,切割构件能够沿位于内侧钉2220b排之间的路径切开组织。
在各种实施例中,如图47所示,内侧钉2220b可成形至低于外侧钉2220a的高度,其中内侧钉2220b可向与切割构件所形成的切割线相邻的组织施加较大的夹紧压力或夹紧力。在至少一个此类实施例中,内侧钉2220b所形成的较大夹紧压力或夹紧力可提供各种有益的治疗效果,例如使被切开组织T减少出血,而外侧钉2220a所形成的较小的夹紧压力可在缝合的组织内提供灵活性。再次参见图46和图47,在各种实施例中,砧座2240还可包括附接到砧座2240的至少一块支撑材料,诸如支撑材料2260。在至少一个此类实施例中,钉2220a,2220b的腿能够当钉仓2200被砧座2240压缩并随后接触砧座2240中的钉成形凹坑2242时,钉2220a,2220b的腿切开支撑材料2260和/或穿过支撑材料2260中的孔。当钉2220a,2220b的腿变形时,所述腿可再次接触和/或切开支撑材料2260。在各种实施例中,支撑材料2260可改善所缝合组织的止血能力和/或为所缝合组织提供强度。
再次参见图46和图47,在各种实施例中,仓体2210的底部表面可包括阶梯式轮廓,所述阶梯式轮廓与仓支撑表面2231的阶梯式轮廓匹配或至少基本上匹配。在某些实施例中,仓体2210的底部表面可变形以匹配或至少基本上匹配仓支撑表面2231的轮廓。现在参见图48,在各种实施例中,类似于图46所示端部执行器的端部执行器例如可包括定位在其中的钉仓2300。钉仓2300可包括具有内层2312和外层2311的可压缩植入式主体2310。其中对上文进行进一步描述,在至少一个实施例中,外层2311可包含水不可渗透的材料。在各种实施例中,外层2311可围绕钉2220a,2220b延伸并可分别位于钉2220a,2220b与支撑狭槽2232a,2232b之间。现在参见图49,在各种实施例中,类似于图46所示端部执行器的端部执行器例如可包括定位在其中的钉仓2400。类似于钉仓2300,钉仓2400的可压缩植入式仓体2410可包括内层2412和外层2411;然而,在至少一个实施例中,仓体2410可以不包括其中的切割构件狭槽。在至少一个此类实施例中,切割构件可需要例如在其穿过钉仓而被推进时切开内层2412和/或外层2411。
现在参见图50,在各种实施例中,外科缝合器的端部执行器可包括砧座2540、钉仓通道2530、以及定位在钉仓通道2530中的钉仓2500。与上文相似,钉仓2500可包括可压缩植入式仓体2510、外侧钉2220a排、以及内侧钉2220b排。钉仓通道2530可包括平的或至少基本上平的仓支撑表面2531及限定在仓支撑表面2531中的钉支撑狭槽2532。砧座2540可包括阶梯式表面2541以及限定在阶梯式表面2541中的多个钉成形凹坑,例如成形凹坑2542a和2542b。与上文相似,成形凹坑2542a与支撑狭槽2532之间可限定有距离,所述距离大于成形凹坑2452b与支撑狭槽2532之间的距离。在各种实施例中,砧座2540还可包括附接到砧座2540的阶梯式表面2541的一块支撑材料2560。在至少一个此类实施例中,支撑材料2560可适形于或至少基本上适形于阶梯式表面2541。在各种实施例中,支撑材料2560可通过至少一种粘合剂(例如,纤维蛋白和/或蛋白水凝胶)可移除地附接到表面2541。在某些实施例中,仓体2510还可包括阶梯式外形,在至少一个实施例中,所述阶梯式外形平行于或至少基本上平行于砧座2540的阶梯式表面2541。更具体地,在至少一个实施例中,砧座2540可包括朝钉仓2500延伸的台阶2548,其中台阶2548可包括台阶高度,所述台阶高度等于或至少基本上等于从仓体2510延伸的台阶2508的台阶高度。在至少一个此类实施例中,由于上文所述,例如可压缩仓体2510可被捕获在第一钉2220a中的量可不同于可压缩仓体2510可被捕获在第二钉2220b中的量。
现在参见图51,在各种实施例中,端部执行器可包括砧座2640、钉仓通道2530、以及位于砧座2640与钉仓通道2530之间的钉仓2600。钉仓2600可包括可压缩植入式仓体2610,仓体2610包括内层2612、外层2611、以及定位在仓体2610中的多个钉(例如钉2220a和2200b)。在各种实施例中,砧座2640可在表面2641中包括多个钉成形凹坑2642,并且钉仓通道2530可包括限定在支撑表面2531中的多个钉成形狭槽2532。如图51所示,砧座表面2641可平行于或至少基本上平行于仓支撑表面2531,其中每个成形凹坑2642可被定位成与相对的且相对应的钉支撑狭槽2532相距相等或至少基本上相等的距离。在各种实施例中,钉仓2600所包括的钉可具有相同或至少基本上相同的初始未成形钉高度以及相同或至少基本上相同的成形钉高度。在某些其他实施例中,外侧钉排可包括钉2220a且内侧钉排可包括钉2220b,其中如上所述,钉2220a和2220b可具有不同的未成形钉高度。当砧座2640朝钉仓2600运动至闭合位置时,钉2220a和2220b可被成形为使钉2220a和2220b具有相同的或至少基本上相同的成形钉高度。在至少一个此类实施例中,由于上文所述,成形外侧钉2220a和内侧钉2220b可以具有相同,或至少基本上相同数量的包含于其中的可压缩的仓体2610;然而,例如由于外侧钉2220a具有比内侧钉2220b更高的未成形钉高度,但可具有相同的成形钉高度,外侧钉2220a中可生成比内侧钉2220b更大的夹紧压力。
现在参见图52,在各种实施例中,外科缝合器的端部执行器可包括砧座2740、钉仓通道2530、以及定位在钉仓通道2530中的钉仓2700。与上文相似,钉仓2700可包括可压缩植入式仓体2710,该仓体包括内层2712、外层2711、以及定位在仓体2710中的多个钉(例如钉2220a和2220b)。在至少一个实施例中,仓体2710的厚度可在其整个宽度上发生变化。在至少一个此类实施例中,仓体2710可包括中心部2708和侧部2709,其中中心部2708的厚度可大于侧部2709的厚度。在各种实施例中,仓体2710的最厚的部分可位于中心部2708处,而仓体2710的最薄的部分可位于侧部2709处。在至少一个此类实施例中,仓体2710的厚度可在中心部2708与侧部2709之间逐渐减小。在某些实施例中,仓体2710的厚度可在中心部2708与侧部2709之间线性地和/或几何地减小。在至少一个此类实施例中,仓体2710的组织接触表面2719可包括从中心部2708朝侧部2709向下倾斜的两个倾斜的或成角度的表面。在各种实施例中,砧座2740可包括两个倾斜的或成角度的表面,所述两个倾斜的或成角度的表面平行于或至少基本上平行于倾斜的组织接触表面2719。在至少一个实施例中,砧座2740还可包括附接到砧座2740的倾斜表面的至少一块支撑材料2760。
在各种实施例中,对上文进行进一步描述,钉仓2700中的内侧钉排可包括较高的钉2220a,并且外侧钉排可包括较低的钉2220b。在至少一个实施例中,较高的钉2220a可被定位在较厚的中心部2708中和/或与中心部2708相邻,而钉2220b可被定位在侧部2709中和/或与侧部2709相邻。在至少一个此类实施例中,由于上文所述,较高的钉2220a可比较低的钉2220b捕获更多的植入式仓体2710的材料。这种情形可使钉2220a比钉2220b对组织T施加更大的夹紧压力。在某些实施例中,尽管较高的钉2220a中可比较低的钉2220b捕获更多的仓体2710的材料,然而由于钉成形凹坑2742a和2742b具有倾斜的结构,因此较高的钉2220a可比较低的钉2220b具有更高的成形钉高度。可利用此类考虑因素在钉2220a和2220b所捕获的组织中获得期望的夹紧压力,因此例如钉2220a中的夹紧压力可大于、小于、或等于钉2220b对组织施加的夹紧压力。在图52所示端部执行器的各种可供选择的实施例中,较低的钉2220b可被定位在仓体2710的较厚的中心部2708中和/或邻近中心部2708,并且较高的钉2220a可被定位在较薄的侧部2709中和/或邻近侧部2709。此外,尽管钉仓2700被绘示成包括内侧及外侧钉排,然而钉仓2700可包括附加的钉排,例如位于内侧钉排与外侧钉排之间的钉排。在至少一个此类实施例中,例如中间钉排的未成形钉高度可介于钉2220a的未成形钉高度与钉2220b的未成形钉高度之间,并且中间钉排的成形钉高度可介于钉2220a的成形钉高度与钉2220b的成形钉高度之间。
现在参见图53,在各种实施例中,外科缝合器的端部执行器可包括砧座2840、钉仓通道2530、以及定位在钉仓通道2530中的钉仓2800。与上文相似,钉仓2800可包括可压缩植入式仓体2810,该仓体包括内层2812、外层2811、以及定位在仓体2810中的多个钉(例如钉2220a和2220b)。在至少一个实施例中,仓体2810的厚度可在其整个宽度上发生变化。在至少一个此类实施例中,仓体2810可包括中心部2808和侧部2809,其中中心部2808的厚度可小于侧部2809的厚度。在各种实施例中,仓体2810的最薄的部分可位于中心部2808处,而仓体2810的最厚的部分可位于侧部2809处。在至少一个此类实施例中,仓体2810的厚度可在中心部2808与侧部2809之间逐渐增大。在某些实施例中,仓体2810的厚度可在中心部2808与侧部2809之间线性地和/或几何地增大。在至少一个此类实施例中,仓体2810的组织接触表面2819可包括从中心部2808朝侧部2809向上倾斜的两个倾斜的或成角度的表面。在各种实施例中,砧座2840可包括两个倾斜的或成角度的表面,所述两个倾斜的或成角度的表面平行于或至少基本上平行于倾斜的组织接触表面2819。在至少一个实施例中,砧座2840还可包括附接到砧座2840的倾斜表面的至少一块支撑材料2860。在各种实施例中,对上文进行进一步描述,钉仓2800中的外侧钉排可包括较高的钉2220a,并且内侧钉排可包括较低的钉2220b。在至少一个实施例中,较高的钉2220a可被定位在较厚的侧部2809中和/或与侧部2809相邻,而钉2220b可被定位在中心部2808中和/或与中心部2808相邻。在至少一个此类实施例中,由于上文所述,较高的钉2220a可比较低的钉2220b捕获更多的植入式仓体2810的材料。
如上文参照图46的实施例所述,例如,钉仓通道2230可包括阶梯式支撑表面2231,该阶梯式支撑表面能够相对于砧座2240将钉2220a及2220b支撑在不同高度处。在各种实施例中,钉仓通道2230可由金属构成,并且支撑表面2231中的台阶可通过例如研磨操作而形成于支撑表面2231中。现在参见图54,在各种实施例中,外科器械的端部执行器可包括钉仓通道2930,该钉仓通道包括定位在其中的支撑插入件2935。更具体地,在至少一个实施例中,钉仓通道2930可被形成为使其具有例如平的或至少基本上平的支撑表面2931,该支撑表面能够支撑插入件2935,该支撑插入件包括用于将钉仓2200的钉2220a和2220b支撑在不同高度处的阶梯式表面。在至少一个此类实施例中,插入件2935可包括平的或至少基本上平的底部表面,所述底部表面可抵靠支撑表面2931定位。插入件2935还可包括支撑狭槽、沟槽、或槽2932a和2932b,支撑狭槽、沟槽、或槽2932a和2932b能够将钉2220a和2220b分别支撑在不同高度处。与上文相似,插入件2935可包括限定在其中的刀狭槽2939,该刀狭槽能够容许切割构件穿过其中。在各种实施例中,钉仓通道2930可由相同或不同于支撑插入件2935的材料构成。在至少一个此类实施例中,钉仓通道2930及支撑插入件2935两者均可例如由金属构成,而在其他实施例中,钉仓通道2930可例如由金属构成,并且支撑插入件2935可例如由塑料构成。在各种实施例中,支撑插入件2935可被紧固和/或焊接到钉仓通道2930中。在某些实施例中,支撑插入件2935可搭扣配合和/或压配到钉仓通道2930中。在至少一个实施例中,可使用粘合剂将支撑插入件2935固定在钉仓通道2930中。
现在参见图55,在各种实施例中,外科缝合器的端部执行器可包括砧座3040、钉仓通道3030、以及位于钉仓通道3030中的可压缩植入式钉仓3000。与上文相似,砧座3040可包括限定在其中的多个钉成形凹坑3042以及能够将切割构件可滑动地容纳在其中的刀狭槽3049。同样类似于上文,钉仓通道3030可包括限定在其中的多个钉支撑狭槽3032以及也能够将切割构件可滑动地容纳在其中的刀狭槽3039。在各种实施例中,钉仓3000可包括第一层3011、第二层3012、以及定位在钉仓3000中的多个钉(例如钉3020a及3020b)。在至少一个实施例中,钉3020a的未成形钉高度可高于钉3020b的未成形钉高度。在各种实施例中,第一层3011可包含第一可压缩材料,并且第二层3012可包含第二可压缩材料。在某些实施例中,第一可压缩材料的压缩率可高于第二可压缩材料,而在某些其他实施例中,第一可压缩材料的压缩率可低于第二可压缩材料。在至少一个实施例中,第一可压缩材料可由可包含第一弹性比率的弹性材料构成,并且第二可压缩材料可由可包含第二弹性比率的弹性材料构成,所述第二弹性比率不同于所述第一弹性比率。在各种实施例中,第一可压缩材料的弹性比率可大于第二可压缩材料的弹性比率。在某些其他实施例中,第一可压缩材料的弹性比率可小于第二可压缩材料的弹性比率。在各种实施例中,第一可压缩层可包含第一刚度,并且第二可压缩层可包含第二刚度,其中第一刚度不同于第二刚度。在各种实施例中,第一可压缩层的刚度可大于第二可压缩层的刚度。在某些其他实施例中,第一可压缩层的刚度可小于第二可压缩层的刚度。
再次参见图55,在各种实施例中,钉仓3000的第二层3012可在其整个宽度上包括恒定的或至少基本上恒定的厚度。在至少一个实施例中,第一层3011的厚度可在其整个宽度上发生变化。在至少一个此类实施例中,第一层3011可包括一个或多个台阶3008,该台阶可在仓体3010的某些部分(例如中心部)中增大仓体3010的厚度。再次参见图55,较低的钉3020b可被定位在台阶3008(即仓体3010的较厚部分)中或与台阶3008对齐,并且较高的钉3020a可被定位在仓体3010的较薄部分中或与所述较薄部分对齐。在各种实施例中,由于仓体3010的较厚部分及较薄部分,仓体3010沿内侧钉3020b排的刚度可大于沿外侧钉3020a排的刚度。在各种实施例中,第一层3011可连接到第二层3012。在至少一个此类实施例中,第一层3011和第二层3012可包括互锁结构,所述互锁结构可将层3011和3012保持在一起。在某些实施例中,第一层3011可包括第一层合物并且第二层3012可包括第二层合物,其中第一层合物可通过一种或多种粘合剂粘附至第二层合物。在各种实施例中,钉仓3000可包括刀狭槽3003,该刀狭槽能够在其中可滑动地容纳切割构件。
现在参见图56,在各种实施例中,钉仓3100可包括可压缩植入式仓体3110,该仓体包括单层可压缩材料以及定位在仓体3110中的多个钉(例如,钉3020b)。在至少一个实施例中,仓体3110的厚度可在其整个宽度上变化。在至少一个此类实施例中,仓体3110可包括沿其侧部延伸的台阶3108。现在参见图57,在各种实施例中,钉仓3200可包括可压缩植入式仓体3210,该仓体包括单层可压缩材料以及定位在仓体3210中的多个钉(例如,钉3020b)。在至少一个实施例中,仓体3210的厚度可在其整个宽度上变化。在至少一个此类实施例中,仓体3210可包括沿其中心部延伸的台阶3208。现在参见图58,在各种实施例中,钉仓3300可包括可压缩植入式仓体3310,其中与上文相似,仓体3310的厚度可在其整个宽度上变化。在至少一个实施例中,仓体3310的厚度可在仓体3310的侧部与中心部之间几何地增大。在至少一个此类实施例中,仓体3310的厚度可由弓形或弯曲的外形限定并可包括弓形或弯曲的组织接触表面3319。在某些实施例中,仓体3310的厚度及组织接触表面3319的轮廓可由例如一个曲率半径或作为另一选择由多个曲率半径限定。现在参见图59,在各种实施例中,钉仓3400可包括可压缩植入式仓体3410,其中仓体3410的厚度可在仓体3410的侧部与中心部之间线性地或至少基本上线性地增大。
现在参见图60,在各种实施例中,钉仓3500可包括可压缩植入式仓体3510以及定位在其中的多个钉3520。植入式仓体3510可包括第一内层3512、第二内层3513、和外层3511。在至少一个实施例中,第一内层3512可包含第一厚度并且第二内层3513可包含第二厚度,其中第二内层3513可厚于第一内层3512。在至少一个可供选择的实施例中,第一内层3512可厚于第二内层3513。在另一可供选择的实施例中,第一内层3512与第二内层3513可具有相同或至少基本上相同的厚度。在某些实施例中,每个钉3520可包括基部3522以及从基部3522延伸的一个或多个可变形腿3521。在各种实施例中,每个腿3521可包括嵌入第一内层3511中的末端3523,另外,钉3520的每个基部3522可嵌入第二内层3512中。在至少一个实施例中,第一内层3512和/或第二内层3513可包括存储在其中的至少一种药物,并且在各种实施例中,外层3511可包封并密封第一内层3512和第二内层3513,使得只有当外层3511被钉3520刺穿之后药物才会流出钉仓体3510。更具体地,对上文进行进一步描述,可抵靠着抵靠钉仓3500的组织接触表面3519而定位的组织向下推动砧座,使得仓体3510被压缩且表面3519朝钉末端3523向下运动并至少部分地在钉末端3523下方运动,使得末端3523使外层3511破裂或刺穿外层3511。在钉腿3521使外层3511破裂之后,至少一种药物M可从围绕钉腿3521的仓体3510流出。在各种情况下,仓体3510的额外压缩可将附加的药物M挤出仓体3510,如图61所示。
再次参见图60,在各种实施例中,外层3511可包括水不可渗透的或至少基本上不可渗透的包裹物,所述包裹物能够1)防止药物过早地流出钉仓3500;以及2)防止例如手术部位内的流体过早地进入钉仓3500中。在某些实施例中,第一内层3512可包括存储或吸收于其中的第一药物,并且第二内层3513可包括存储或吸收于其中的第二药物,其中第二药物可不同于第一药物。在至少一个实施例中,仓体3510的使外层3511破裂的初始压缩通常可使第一内层3512释放出第一药物,并且仓体3510的后续压缩通常可使第二内层3513释放出第二药物。然而,在此类实施例中,第一药物和第二药物的某些部分可同时被释放,但最初被释放的药物的大部分可由第一药物构成,并且随后被释放的药物的大部分可由第二药物构成。在某些实施例中,对上文进行进一步描述,第一内层3512可由比第二内层3513具有更大可压缩性的材料构成,使得可低于后续压缩力或压力的初始压缩力或压力可在第一内层3512中产生比第二内层3513中更大的初始挠曲量。第一内层3512中的此类较大的初始挠曲量可使从第一内层3512中释放出的第一药物的部分大于从第二内层3513中释放出的第二药物。在至少一个实施例中,第一内层3512可比第二内层3513更加多孔和/或更具柔性。在至少一个此类实施例中,第一内层3512可包括限定在其中的多个孔或空隙3508,并且第二内层3513可包括限定在其中的多个孔或空隙3509,其中在各种实施例中,孔3508能够将第一药物存储在第一内层3512中,并且孔3509能够将第二药物存储在第二内层3513中。在某些实施例中,第一内层3512中的孔3508和第二内层3513中的孔3509的尺寸及密度可被选择成提供本文所述的所需结果。
再次参见图60及图61,在各种实施例中,外层3511、第一内层3512、和/或第二内层3513可由可生物吸收的材料构成。在至少一个实施例中,第一内层3512可包含第一可生物吸收的材料,第二内层3513可包含第二可生物吸收的材料,并且外层3511可由第三可生物吸收的材料构成,其中第一可生物吸收的材料、第二可生物吸收的材料、和/或第三可生物吸收的材料可由不同的材料构成。在某些实施例中,第一可生物吸收的材料可以第一速率被生物吸收,第二可生物吸收的材料可以第二速率被生物吸收,并且第三可生物吸收的材料可以第三速率被生物吸收,其中第一速率、第二速率、和/或第三速率可不同。在至少一个此类实施例中,当材料以特定的速率被生物吸收时,此类速率可被定义成在单位时间内被患者身体吸收的材料质量的量。众所周知,不同患者的身体可以不同的速率吸收不同的材料,因此此类速率可被表达成平均速率以解释此类可变性。在任何情形中,与较慢的速率相比,较快的速率可为在单位时间内更多的质量被吸收的速率。再次参见图60和图61,在各种实施例中,第一内层3512和/或第二内层3513的构成材料可比外层3511的构成材料更快地被生物吸收。在至少一个此类实施例中,第一内层3512和/或第二内层3513可由可生物吸收的泡沫、组织密封剂、和/或止血材料(例如氧化再生纤维素(ORC))构成,并且外层3511可由支撑材料和/或塑性材料(例如以商品名Vicryl出售的聚乙醇酸(PGA)、聚乳酸(PLA或PLLA)、聚对二氧环己酮(PDS)、聚羟基链烷酸酯(PHA)、以商品名Monocryl出售的聚卡普隆25(PGCL)、聚己内酯(PCL)、和/或PGA、PLA、PDS、PHA、PGCL、和/或PCL的复合物)构成。在此类实施例中,第一内层3512和/或第二内层3513例如可直接处理组织并可减少组织出血,其中外层3514可提供长期的结构支撑并可以较慢的速率被生物吸收。
对上文进行进一步描述,由于外层3511的可生物吸收的速率较慢,因此外层3511可在钉行内的组织愈合时支撑组织或在结构上增强组织。在某些实施例中,第一内层3512和第二内层3513其中之一的构成材料可比另一者的构成材料更快地被生物吸收。在至少一个实施例中,其中的一层可提供治疗材料的初始释放,并且另一层可提供相同治疗材料和/或不同治疗材料的缓释。在至少一个此类实施例中,治疗材料可从层3512,3513被释放的速率可取决于其中吸收或分散有药物的最底层的可吸收性。例如,在至少一个实施例中,包括第一内层3512的基板可比包括第二内层3513的基板更快地被生物吸收,因此例如药物从第一内层3512释放的速度可快于从第二内层3513的释放的速度。在各种实施例中,如本文所述,仓体3510的层3511,3512,和3513中的一个或多个可通过至少一种粘合剂(例如,纤维蛋白和/或蛋白水凝胶)相互粘附。在某些实施例中,粘合剂可为可水溶的并能够当钉仓3500被植入时和/或被植入某段时间之后释放各层之间的连接。在至少一个此类实施例中,粘合剂能够比外层3511、第一内层3512、和/或第二内层3513更快地被生物吸收。
现在参见图62及图63,在各种实施例中,钉仓(例如,钉仓3600)例如可包括仓体3610,该仓体包括可压缩的第一层3611、附接到第一层3611的第二层3612、以及附接到第二层3612的可移除的可压缩层3613。在至少一个此类实施例中,例如第一层3611可由可压缩的泡沫材料构成,第二层3612可包括利用一种或多种粘合剂粘附到第一层3611的层合材料,并且第三层3613可包括利用一种或多种粘合剂可移除地粘附到第二层3612的可压缩泡沫材料。在各种实施例中,钉仓3600还可包括位于仓体3610中的多个钉(例如钉3620)。在至少一个此类实施例中,例如每个钉3620可包括位于第三层3613中的基部3622以及从基部3622穿过第二层3612而向上延伸至第一层3611中的一个或多个可变形腿3621。在使用中,对上文进行进一步描述,钉仓体3610的顶部表面3619可被砧座向下推动,直至钉腿3621穿透顶部表面3619及靶组织并接触砧座。在钉腿3621完全变形之后,砧座可远离钉仓3600运动,使得钉仓3600的可压缩层可至少部分地再次伸展。在各种情况下,钉穿过组织而插入时可使组织出血。在至少一个实施例中,第三层3613可由吸收材料(例如蛋白水凝胶)构成,所述吸收材料可从被缝合的组织吸除血液。除上文之外或作为上文的替代,第三层3613可由止血材料和/或组织密封剂(例如经冷冻干燥的凝血酶和/或纤维蛋白)构成,所述止血材料和/或组织密封剂能够减少组织出血。在某些实施例中,第三层3613可对第一层3611和第二层3612提供结构支撑,其中第三层3613可由可生物吸收的材料和/或不可生物吸收的材料构成。在任何情形中,在各种实施例中,在钉仓3610被植入之后,第三层3613可与第二层3612分离。在其中第三层3613包括具有植入式特性的材料的实施例中,外科医生可选择是否移除仓体3610的第三层3613。在至少一个实施例中,第三层3613能够以整体形式从第二层3612移除。
在各种实施例中,第一层3611可由第一泡沫材料构成,并且第三层3613可由第二泡沫材料构成,第二泡沫材料可不同于第一泡沫材料。在至少一个实施例中,第一泡沫材料可具有第一密度并且第二泡沫材料可具有第二密度,其中第一密度可不同于第二密度。在至少一个此类实施例中,第二密度可高于第一密度,因此第三层3613可比第一层3611的可压缩性更小或具有更低的压缩率。在至少一个可供选择的实施例中,第一密度可高于第二密度,因此,第一层3611可比第三层3613的可压缩性更小或具有更低的压缩率。现在参见图64和图65,在各种实施例中,类似于钉仓3600,钉仓3700可包括仓体3710,该仓体包括第一可压缩的泡沫层3711、附接到第一层3711的第二层3712、以及可移除地附接到第二层3712的可拆卸的第三可压缩泡沫层3713。在至少一个此类实施例中,第三层3713可包括多个钉容纳狭槽或切口3709,所述多个钉容纳狭槽或切口可分别能够在其中容纳钉3620的至少一部分(例如钉基部3622)。在某些实施例中,钉3620能够在钉容纳狭槽3709中滑动,或换句话讲,例如当钉仓3700抵靠靶组织而定位并被砧座压缩时,第三层3713能够相对于钉3620滑动。在至少一个实施例中,容纳狭槽3709能够使钉3620与容纳狭槽3709的侧壁之间存在空隙。在至少一个此类实施例中,由于上文所述,当钉3620变形时,钉3620可不将第三层3713的一部分捕获在其中,如图64和图65所示。在某些其他实施例中,钉容纳狭槽3709的邻近第二层3712的末端可由第三层3713的一部分闭合,因此当钉3620变形时,第三层3713的至少一部分可被捕获在钉3620内。在任何情形中,第三层3713例如可包括一个或多个穿孔和/或划痕3708,所述一个或多个穿孔和/或划痕能够容许第三层3713以两个部分或更多个部分从第二层3712被移除,如图64所示。在图64中,第三层3713的其中一部分被示为通过工具3755移除。在各种实施例中,穿孔3708可沿位于第一排钉与第二排钉中间的线设置。
再次参见图64和图65,在各种实施例中,钉3620的基部3622可位于容纳狭槽3709中,其中在至少一个实施例中,容纳狭槽3709的侧壁能够接触钉腿3621并将钉腿3621可释放地保持就位。在某些实施例中,尽管未示出,然而第三层3713可包括围绕钉行内所有钉的细长狭槽。在至少一个此类实施例中,包括四个钉排的钉仓例如可包括与钉仓底层中的每个钉排对齐的细长狭槽。对上文进行进一步描述,钉仓3600和/或钉仓3700的至少一部分可被植入患者体内,并且钉仓的至少一部分可从患者体内移除。再次参见图64和图65,在至少一个实施例中,第一层3711和第二层3712可被捕获在钉3620内并可与钉3620一起被植入,而第三层3713可任选地从钉仓3700中被移除或分离。在各种情况下,移除已植入钉仓的一部分可减少患者身体必须吸收的材料的量,这可提供各种有益的治疗效果。在例如通过腹腔镜式工具3755将钉仓的一部分分离并移除的情形中,所分离的钉仓部分可通过套管针(例如具有5mm孔的套管针)从手术部位被移除。在某些实施例中,仓体可包括多于一个的可被移除的层。例如,仓体3710可包括第四层,其中仓体3710的第三层3713可由止血材料构成,并且第四层可由支撑层构成。在至少一个此类实施例中,外科医生例如可移除支撑层并随后选择是否移除止血层。
现在参见图66,在各种实施例中,钉仓(例如,钉仓3800)例如可包括仓体3810,该仓体包括外层3811及内层3812。内层3812可由可压缩的泡沫材料构成,并且外层3811可至少部分地围绕内层3812进行包裹。在至少一个实施例中,外层3811可包括第一部分3811a和第二部分3811b,该第一部分能够定位在内层3812的第一侧上,该第二部分能够定位在内层3812的第二侧上,其中第一部分3811a和第二部分3811b可通过柔性铰链(例如铰链3809)连接。在至少一个此类实施例中,可对内层3812的第一侧和/或第二侧涂覆至少一种粘合剂(例如,纤维蛋白和/或蛋白水凝胶)以将外层3811的某些部分固定至第一侧和/或第二侧。在各种实施例中,外层3811可包括从其延伸的一个或多个紧固构件。在至少一个此类实施例中,外层3811可包括从外层3811的一侧延伸并可被安放在可压缩内层3812中的多个可变形腿3821。在至少一个此类实施例中,腿3821可不从内层3812的第二侧突起,而在至少一个可供选择的实施例中,腿3821可至少部分地从内层3812突起。当可压缩仓体3810被压缩时,在使用中,腿3821能够刺穿内层3812及外层3811的第二部分3811b。在某些实施例中,外层3811的第二部分3811b可包括限定在其中的孔(例如孔3808),所述孔能够容纳钉腿3821。在某些实施例中,钉仓3800的至少某些部分可包括刀狭槽3803,该刀狭槽能够在其中可滑动地容纳切割构件。在至少一个此类实施例中,刀狭槽3803可不完全穿过仓体3810的厚度而延伸,因此当切割构件相对于仓体3810运动时,切割构件可切开仓体3810。
现在参见图67,在各种实施例中,与钉仓3800相似,钉仓3900可包括仓体3910,该仓体包括内层3812及外层3811,其中外层3811可包括邻近内层3812的第一侧而定位的第一部分3811a以及邻近内层3812的第二侧而定位的第二部分3811b。在至少一个实施例中,与上文相似,外层3811可包括从其延伸的一个或多个紧固构件。在至少一个此类实施例中,外层3811可包括自外层3811的一侧延伸并可被安放于可压缩内层3812中的多个可变形腿3921。在某些实施例中,每个可变形腿3921可包括从其突起的至少一个吊钩或倒钩3923,所述至少一个吊钩或倒钩能够接合外层3811的第二部分3811b并因此将外层3811保持到内层3812。在至少一个此类实施例中,倒钩3923能够从内层3812的第二侧突起并延伸穿过外层3811的第二部分3811b中的孔3808,使得倒钩3923可接合外层3811的外表面并将外层3811锁定到内层3812。为构造钉仓3900,内层3812可被至少部分地压缩,以使倒钩从内层3812突起并进入孔3808中。在至少一个此类实施例中,例如当钉仓3900被插入钉仓中时,钉仓3900可被至少部分地预压缩。在某些实施例中,对上文进行进一步描述,腿3921的至少一部分可嵌入外层3811的第一部分3811a中,其中在至少一个实施例中,外层3811可由塑性材料(例如聚对二氧环己酮(PDS)和/或聚乙醇酸(PGA))构成,并且所述塑性材料可围绕腿3921的至少一部分重叠注塑。
现在参见图68-72,在各种实施例中,钉仓(例如,钉仓4000)可包括仓体4010,该仓体包括可压缩的第一层4011、第二层4012、以及定位在仓体4010中的多个钉4020。参见图70,在某些实施例中,每个钉4020可包括基部4022以及从基部4022延伸的至少一个可变形腿4023。参见图68,在至少一个实施例中,钉仓4000可被定位在钉仓通道4030与外科缝合器的端部执行器的砧座4040之间,其中仓体4010的第二层4012和/或钉4020的基部4022可抵靠钉仓通道4030定位。现在参见图69,在各种实施例中,第二层4012可包括一层脱脂棉4060,所述一层脱脂棉通过脱脂棉支撑框架4061彼此互连。在至少一个此类实施例中,脱脂棉4060及脱脂棉支撑框架4061可由模制的塑性材料(例如聚乙醇酸(PGA))构成。每个脱脂棉4060可包括一个或多个孔或狭槽4062,所述一个或多个孔或狭槽能够容纳延伸穿过其中的钉腿4021,如图70和图71所示。每个脱脂棉4060还可包括限定在其中的容纳狭槽4063,该容纳狭槽能够容纳钉4020的基部4022。再次参见图69,在各种实施例中,脱脂棉4060和/或脱脂棉支撑框架4061可包括多个划痕、穿孔或类似结构,所述多个划痕、穿孔或类似结构能够容许脱脂棉4060在所需位置处与脱脂棉支撑框架4061分离。相似地,参见图71,一个或多个脱脂棉4060例如可沿包括穿孔和/或划痕4064的线彼此连接。在使用中,可压缩的泡沫层4011可抵靠靶组织T而定位,并且仓体4010可由砧座4040压缩以使砧座4040能够使钉4020变形。当钉4020变形时,每个钉4020的钉腿4021可将组织T、第一层4011的一部分、以及脱脂棉4060捕获在变形的钉内。当钉仓通道4030远离已植入的钉仓4060运动时,例如脱脂棉支撑框架4061可与脱脂棉4060分离和/或各脱脂棉4060可彼此分离。在某些情形中,当钉4020被砧座4040以上述方式变形时,脱脂棉4060可与框架4061和/或彼此分离。
在本文所述的各种实施例中,当砧座运动到闭合位置时,钉仓的钉可由砧座完全成形。现在参见图73-76,在各种其他实施例中,钉仓(例如钉仓4100)的钉例如可通过运动至闭合位置的砧座以及使钉朝闭合的砧座运动的钉驱动器系统而变形。钉仓4100可包括可压缩仓体4110,该可压缩仓体可例如由泡沫材料以及至少部分地位于可压缩仓体4110内的多个钉4120构成。在各种实施例中,钉驱动器系统可包括驱动器夹持器4160、位于驱动器夹持器4160内的多个钉驱动器4162、以及钉仓盘4180,该钉仓盘能够将钉驱动器4162保持在驱动器夹持器4160中。在至少一个此类实施例中,钉驱动器4162可被定位在驱动器夹持器4160中的一个或多个狭槽4163内,其中狭槽4163的侧壁可帮助朝砧座向上引导钉驱动器4162。在各种实施例中,钉4120可由钉驱动器4162支撑在狭槽4163内,其中在至少一个实施例中,当钉4120及钉驱动器4162处于其未击发位置时,钉4120可完全位于狭槽4163中。在某些其他实施例中,当钉4120及钉驱动器4162处于其未击发位置时,钉4120的至少一部分可穿过狭槽4163的开口端4161向上延伸。现在首先参见图74,在至少一个此类实施例中,钉4120的基部可被定位在驱动器夹持器4160内,并且钉4120的末端可嵌入可压缩仓体4110内。在某些实施例中,钉4120的大约三分之一的高度可被定位在驱动器夹持器4160内,并且钉4120的大约三分之二的高度可被定位在仓体4110内。参见图73A,在至少一个实施例中,例如钉仓4100还可包括围绕仓体4110及驱动器夹持器4160的水不可渗透的包裹物或膜4111。
在使用中,例如,钉仓4100可位于钉仓通道内,并且砧座可朝钉仓4100运动到闭合位置。在各种实施例中,当砧座运动至其闭合位置时,砧座可接触并压缩可压缩仓体4110。在某些实施例中,当砧座处于其闭合位置时,砧座可不接触钉4120。在某些其他实施例中,当砧座运动至其闭合位置时,砧座可接触钉4120的腿并至少部分地使钉4120变形。在任一情形中,钉仓4100还可包括一个或多个滑动件4170,所述一个或多个滑动件可在钉仓4100内沿纵向推进,使得滑动件4170可随后接合钉驱动器4162并使钉驱动器4162及钉4120朝砧座运动。在各种实施例中,滑动件4170可在钉仓盘4180与钉驱动器4162之间滑动。在其中砧座的闭合已使钉4120的成形过程开始的实施例中,钉4120朝砧座向上运动可完成成形过程并使钉4120变形至其完全成形的高度或至少期望的高度。在其中砧座的闭合未使钉4120变形的实施例中,钉4120朝砧座向上运动可开始并完成成形过程并使钉4120变形至其完全成形的高度或至少期望的高度。在各种实施例中,滑动件4170可从钉仓4100的近端推进到钉仓4100的远端,使得在位于钉仓4100的远端中的钉4120完全成形之前,位于钉仓4100的近端中的钉4120完全成形。参见图75,在至少一个实施例中,滑动件4170可各自包括至少一个成角度的或倾斜的表面4711,其能够在钉驱动器4162下方滑动并如图76所示提升钉驱动器4162。
在各种实施例中,对上文进行进一步描述,钉4120可被成形,以便将组织T的至少一部分及钉仓4100的可压缩仓体4110的至少一部分捕获在其中。在钉4120成形之后,外科缝合器的砧座及钉仓通道4130可远离已植入的钉仓4100运动。在各种情况下,仓盘4180可以固定方式接合钉仓通道4130,因此当钉仓通道4130被拉离已植入的仓体4110时,仓盘4180可与可压缩仓体4110分离。再次参见图73,在各种实施例中,仓盘4180可包括相对的侧壁4181,该仓体4110能够可移除地定位在相对的侧壁4181之间。在至少一个此类实施例中,可压缩仓体4110可被压缩于侧壁4181之间,使得在使用期间仓体4110能够可移除地保持在侧壁4181之间,且当仓盘4180被拉离时,仓体4110从仓盘4180可释放地脱离。在至少一个此类实施例中,驱动器夹持器4160可连接到仓盘4180,使得当仓盘4180自手术部位被移除时,驱动器保持器4160、驱动器4162、和/或滑动件4170可保持在仓盘4180中。在某些其他实施例中,驱动器4162可从驱动器夹持器4160中被射出并留在手术部位中。在至少一个此类实施例中,各驱动器4162可由例如以商品名Vicryl出售的聚乙醇酸(PGA)、聚乳酸(PLA或PLLA)、聚对二氧环己酮(PDS)、聚羟基链烷酸酯(PHA)、以商品名Monocryl出售的聚卡普隆25(PGCL)、聚己内酯(PCL)、和/或PGA、PLA、PDS、PHA、PGCL、和/或PCL的复合物等可生物吸收的材料构成。在各种实施例中,驱动器4162可附接到钉4120,使得驱动器4162部署有钉4120。在至少一个此类实施例中,每个驱动器4162可包括例如能够容纳钉4120的基部的槽,其中在至少一个实施例中,所述槽能够以压配方式和/或搭扣配合方式容纳钉基部。
在某些实施例中,对上文进行进一步描述,驱动器夹持器4160和/或滑动件4170可从仓盘4180中被射出。在至少一个此类实施例中,滑动件4170可在仓盘4180与驱动器夹持器4160之间滑动,使得当滑动件4170推进以向上驱动钉驱动器4162及钉4120时,滑动件4170也可使驱动器夹持器4160向上运动到仓盘4180之外。在至少一个此类实施例中,驱动器夹持器4160和/或滑动件4170可由例如以商品名Vicryl出售的聚乙醇酸(PGA)、聚乳酸(PLA或PLLA)、聚对二氧环己酮(PDS)、聚羟基链烷酸酯(PHA)、以商品名Monocryl出售的聚卡普隆25(PGCL)、聚己内酯(PCL)、和/或PGA、PLA、PDS、PHA、PGCL、和/或PCL的复合物等可生物吸收的材料构成。在各种实施例中,滑动件4170可整体地形成和/或附接到驱动棒或切割构件,所述驱动棒或切割构件穿过钉仓4100而推动滑动件4170。在此类实施例中,滑动件4170可不从仓盘4180中被射出并可与外科缝合器保持在一起,而在滑动件4170未附接到驱动棒的其他实施例中,滑动件4170可留在手术部位中。在任何情形中,对上文进行进一步描述,仓体4110的可压缩性可容许在外科缝合器的端部执行器中使用较厚的钉仓,这是因为当缝合器的砧座闭合时,仓体4110可压缩或塌缩。在某些实施例中,由于在砧座闭合时钉被至少部分地变形,因此可使用较高的钉(例如具有大约0.18"钉高度的钉),例如其中大约0.12"的钉高度可被定位在可压缩层4110中,并且其中可压缩层4110可具有大约0.14"的未压缩高度。
现在参见图77-80,在各种实施例中,钉仓(例如,钉仓4200)例如可包括可压缩仓体4210、位于可压缩仓体4210中的多个钉4220、以及多个柔性的横向支撑构件4234。现在参见图78,在各种实施例中,钉仓4200可被定位在砧座4240与钉仓通道4230中间,其中在至少一个实施例中,侧向支撑构件4234可附接到钉仓通道4230。当砧座4240向下运动以压缩仓体4210并至少部分地使钉4220变形时,如图79所示,仓体4210的侧部可侧向地膨胀并向外推动侧向支撑构件4234。在至少一个此类实施例中,侧向支撑构件4234可附接到仓体4210,并且当仓体4210如上所述侧向地膨胀时,侧向支撑构件4234可与仓体4210分离,如图79所示。在至少一个实施例中,侧向支撑构件4234可利用至少一种粘合剂(例如,纤维蛋白和/或蛋白水凝胶)粘附到仓体4210。与上文相似,砧座4240闭合时可仅部分地使钉4220变形,其中可通过如图80所示穿过钉仓4200推进一个或多个滑动件4270来完成钉4220的成形。现在参见图82和图83,在各种实施例中,滑动件4270可被切割构件4280从钉仓4200的近端推进到钉仓4200的远端。在至少一个此类实施例中,切割构件4280可包括切割元件或刀4283,所述切割元件或刀4283可穿过组织T和/或可压缩仓体4210而推进。在某些实施例中,切割构件4280可包括凸轮构件4282,该凸轮构件可沿钳口4230及4240的外表面推进并将所述钳口运动或保持就位。在各种实施例中,由于上文所述,钉4220可在组织T被切开的同时或至少基本上同时被成形至其最终形状。在至少一个此类实施例中,滑动件4270可相对于刀4283被定位在远侧,使得仅在组织的推进部分被完全缝合时组织T才被切开。
再次参见图82和图83,在各种实施例中,滑动件4270可包括单独的可滑动构件,所述可滑动构件一起由切割构件4280推进。在至少一个此类实施例中,滑动件4270可被容纳在钉仓4200中,并且切割构件4280可被击发杆4281推进至钉仓4200中,使得切割构件4280接合滑动件4270并朝远侧推进滑动件4270。在某些实施例中,各滑动件4270可彼此连接。在任一种情形中,每个滑动件4270可包括成角度的表面或凸轮4271,该成角度的表面或凸轮能够提升在钉排中对齐的钉4220。在某些实施例中,成角度的表面4271可与切割构件4280形成为整体。再次参见图82和图83,在至少一个实施例中,每个钉4200可包括基部及冠部4229,至少一个可变形构件从基部延伸,并且冠部4229重叠注塑到钉4200的基部和/或可变形构件的至少一部分上、和/或围绕所述至少一部分而定位。在各种实施例中,例如此类冠部4229能够由滑动件4270直接驱动。更具体地,在至少一个实施例中,钉4220的冠部4229能够使得在滑动件4270的成角度的表面4271与冠部4229之间未定位有钉驱动器的情况下,成角度的表面4271可在冠部4229下方滑动并直接接触冠部4229。在此类实施例中,每个冠部4229均包括至少一个协作的成角度或倾斜的表面,所述至少一个协作的成角度或倾斜的表面可由滑动件4270的成角度的表面4271接合,使得当滑动件4270在钉4220下方滑动时,协作的成角度表面可向上驱动钉4220。
现在参见图81,在各种实施例中,钉仓(例如,钉仓4300)例如可包括可压缩的主体4310以及定位在可压缩的主体4310中的多个钉4320。与上文相似,钉仓4300可包括柔性的侧向支撑件4334,该柔性的侧向支撑件可附接到钉仓通道和/或粘附到可压缩的主体4310。除上文所述者之外,柔性的侧向支撑件4334可由一个或多个支柱或连接构件4335连接到一起,所述一个或多个支柱或连接构件4335能够将侧向支撑件4334保持在一起。在使用中,连接构件4335能够防止或至少抑制侧向支撑件4334过早地与仓体4310分离。在某些实施例中,连接构件4335能够在钉仓4300被砧座压缩之后,该连接构件将侧向支撑件4334保持在一起。在此类实施例中,侧向支撑件4334可抵抗仓体4310的侧部的侧向膨胀或位移。在某些实施例中,切割构件(例如切割构件4280)能够当切割构件4280在仓体4310中朝远侧运动时,切割构件会横切连接构件4335。在至少一个此类实施例中,切割构件4280能够朝远侧推动一个或多个滑动件(例如滑动件4270),以便使钉4320抵靠砧座而成形。滑动件4270可引导切刃4283,使得切割构件4280不会横切连接构件4335,直至邻近连接构件4335的钉4320完全成形或至少成形至期望高度。在各种情况下,连接构件4335与侧向支撑件4334协作可防止或至少减少可压缩仓体4310的侧向运动,并同时防止或至少减少位于仓体4310内的钉4320的侧向运动。在这种情形中,连接构件4335可将钉4320保持就位,直至钉4320变形,并且连接构件4335可随后切割以释放仓体4310的侧部。如上所述,侧向支撑件4334可连接到钉仓通道,因此在钉仓4300被植入之后,侧向支撑件4334可与钉仓通道一起从手术部位被移除。在某些实施例中,侧向支撑件4334可由植入式材料构成并可被留在手术部位中。在至少一个实施例中,连接构件4335可被定位在仓体4310与组织T中间,并且在连接构件4335与侧向支撑件4334分离之后,连接构件4335可保持植入患者体内。在至少一个此类实施例中,连接构件4335可由植入式材料构成,并且在某些实施例中,连接构件4335可例如由与侧向支撑构件4334相同的材料构成。在各种实施例中,连接构件4335和/或侧向支撑件4334可由例如以商品名Vicryl出售的聚乙醇酸(PGA)、聚乳酸(PLA或PLLA)、聚对二氧环己酮(PDS)、聚羟基链烷酸酯(PHA)、以商品名Monocryl出售的聚卡普隆25(PGCL)、聚己内酯(PCL)、和/或PGA、PLA、PDS、PHA、PGCL、和/或PCL的复合物等柔性的可生物吸收的材料构成。在各种实施例中,连接构件可包括用于连接各侧向支撑件4334的材料片。在某些实施例中,钉仓可包括延伸穿过仓体4310的顶部表面的连接构件以及围绕仓体4310的底部表面而延伸的连接构件。
现在参见图84,在各种实施例中,钉仓可包括钉(例如,钉4420),所述钉例如可包括被插入冠部中的线材部。在至少一个实施例中,冠部可由金属(例如钛和/或不锈钢)和/或塑料(例如聚对二氧环己酮(PDS)和/或聚乙醇酸(PGA))构成。在至少一个实施例中,冠部分可由金属(例如钛和/或不锈钢)和/或塑料(例如聚对二氧环己酮(PDS)和/或聚乙醇酸(PGA))构成。在某些实施例中,每个钉4420的线材部可包括基部4422以及从基部4422延伸的可变形腿4421,其中每个钉4420的冠部可包括冠部4429,该冠部能够在其中容纳基部4422的至少一部分。现在参见图85A-85C,为组装每个钉4420的各部分,可将线材部的腿部4421插入冠部4429中的开口4426中,其中开口4426能够将腿4421引导至基部腔室4427中。线材部还可被插入冠部4429中,使得腿4421离开基部腔室4427且线材部的基部4422进入基部腔室4427中。在至少一个此类实施例中,基部腔室4427能够使得当基部4422进入基部腔室4427时,线材部在冠部4429中旋转,以使钉腿4421指向向上的或至少基本上向上的方向。再次参见图84,在各种实施例中,冠部4429可包括出口孔4425,该出口孔能够在其中容纳钉腿4421。
在各种实施例中,对上文进行进一步描述,外科缝合器可包括滑动件4470,该滑动件能够横贯钉仓4400和钉仓通道4430并使仓体4410内所容纳的钉4420朝砧座运动。在各种情况下,滑动件4470可从钉仓通道4430的近端运动到仓通道4430的远端,以植入仓体4410和钉4420。在某些情形中,滑动件4470可缩回或返回到仓通道4430的近端,并且另一钉仓4400可被插入仓通道4430中。一旦新的钉仓4400被定位在仓通道4430中,则滑动件4470可再次朝远侧推进。在各种实施例中,外科缝合器可包括一个或多个锁定结构,所述一个或多个锁定结构可在仓通道4430中未定位有新的钉仓4400的情况下防止滑动件4470再次朝远侧推进。再次参见图84,在至少一个此类实施例中,钉仓通道4430可包括锁定肩部4439,该锁定肩部能够防止或至少限制滑动件4470朝远侧运动。更具体地,除非滑动件4470由提升结构4428至少部分地向上提升超过肩部4439,否则滑动件4470能够邻接肩部4439,提升结构4428例如在钉仓4400内的最近侧钉4420之间延伸。换句话讲,当新的钉仓4400中不存在最近侧钉4420时,滑动件4470无法推进。因此,当仓通道4430中存在已用过的钉仓4400时或仓通道4430中不存在任何钉仓4400时,滑动件4470无法在仓通道4430中推进。
现在参见图86,对上文进行进一步描述,钉仓(例如,钉仓4500)例如可被定位在钉仓通道4530中并可包括可压缩仓体4510、定位在仓体4510中的多个钉4520、以及仓盘或保持器4580。在各种实施例中,可压缩仓体4510可包括外层4511及内层4512,其中在至少一个实施例中,外层4511可以密封方式包围内层4512。在至少一个此类实施例中,外层4511可在内层4512与仓盘4580之间延伸。在某些其他实施例中,外层4511可仅部分地围绕内层4512,并且在至少一个此类实施例中,外层4511和仓盘4580可协作以包围或至少基本上包围内层4512。在各种实施例中,对上文进行进一步描述,钉4520可由仓盘4580支撑,其中仓盘4580可包括能够支撑钉4520的一个或多个钉支撑通道。在某些实施例中,仓盘4580可附接到仓体4510,其中在至少一个此类实施例中,仓体4510可在仓盘4580的相对的侧壁之间被侧向地压缩。在各种实施例中,仓盘4580的侧壁可侧向地支撑仓体4510,在至少一个此类实施例中,仓盘4580可包括从底部支撑件4583向上延伸至仓体4510中的一个或多个壁或翅片4582。在至少一个此类实施例中,仓体4510中可包括一个或多个狭槽或通道,所述一个或多个狭槽或通道能够容纳壁4582和/或与壁4582互锁。在各种实施例中,壁4582可部分地或几乎全部地延伸穿过仓体4510。在至少一个此类实施例中,壁4582可在第一排钉4520与第二排钉4520之间纵向延伸穿过钉仓4500。
在各种实施例中,仓体4510和/或仓盘4580可包括协作保持结构,所述协作保持结构可在仓盘4580与仓体4510之间提供搭扣配合。在某些实施例中,钉仓4500可被定位在仓通道4530中,使得仓盘4580抵靠仓通道4530而定位和/或附接到仓通道4530。在至少一个实施例中,仓盘4580能够可分离地联接到仓通道4530,使得在钉仓4500被砧座4540压缩且钉4520变形之后,仓盘4580可与仓通道4530分离并可与仓体4510一起被植入。在至少一个此类实施例中,仓盘4580可由例如以商品名Vicryl出售的聚乙醇酸(PGA)、聚乳酸(PLA或PLLA)、聚对二氧环己酮(PDS)、聚羟基链烷酸酯(PHA)、以商品名Monocryl出售的聚卡普隆25(PGCL)、聚己内酯(PCL)、和/或PGA、PLA、PDS、PHA、PGCL、和/或PCL的复合物等可生物吸收的材料构成。在某些实施例中,外科缝合器还可包括击发机构和/或驱动器,所述击发机构和/或驱动器可在仓盘4580上在钉仓通道4530与底部驱动表面中间滑动,所述底部驱动表面能够从仓通道4530中提升或射出仓盘4580。在某些实施例中,仓体4510能够可分离地联接到仓盘4580,使得在钉仓4500被砧座4540压缩且钉4520变形之后,仓体4510可从仓盘4580分离。在至少一个此类实施例中,仓盘4580可保持以固定方式接合仓通道4530,使得仓盘4580与仓通道4530一起从手术部位被移除。在某些实施例中,外科缝合器还可包括击发机构和/或驱动器,所述击发机构和/或驱动器可在仓体4510上在钉仓盘4580与底部驱动表面中间滑动,所述底部驱动表面能够从仓盘4580中提升或射出仓体4510。在至少一个此类实施例中,钉仓4500还可包括位于仓盘4580与钉4520中间的钉驱动器,使得当击发机构朝远侧滑动时,钉驱动器及钉4520可朝砧座被向上驱动。在至少一个此类实施例中,钉驱动器可至少部分地嵌入可压缩仓体4510中。
在各种实施例中,与上文相似,钉仓4500可包括锁定结构,所述锁定结构能够防止或至少限制切割构件朝远侧运动,除非钉仓通道4530中已定位有未击发的钉仓4500。在某些实施例中,钉仓盘4580可包括例如用于在钉仓通道4530内向上提升切割构件并使其超过锁定表面的表面。在其中仓通道4530中不存在包括仓盘4580的钉仓4500的情形中,切割构件无法推进。在至少一个实施例中,钉仓4500内的最近侧钉和/或任何其他合适的钉可包括提升表面,所述提升表面可完全将切割构件提升超过锁定表面。除上文所述之外或替代上文所述,钉仓4500的各部分可由具有不同颜色的材料构成。在此类实施例中,外科医生能够在视觉上识别钉仓通道4530中何时存在未击发和/或击发的钉仓。在至少一个此类实施例中,仓体4510的外层4511可具有第一颜色,仓盘4580可具有第二颜色,并且钉仓通道4530可具有第三颜色。在外科医生看到第一颜色的情形中,外科医生可知道未击发的仓4500存在于钉仓通道4530中;在外科医生看到第二颜色的情形中,外科医生可知道击发的仓4500存在于钉仓通道4530中,并且剩余的仓盘4580需要移除;以及在外科医生看到第三颜色的情形中,外科医生可知道钉仓4500的任何部分都不保持在钉仓通道4530中。
现在参见图87,在各种实施例中,钉仓(例如,钉仓4600)例如可包括可压缩植入式仓体4610以及定位在仓体4610中的多个钉4620。仓体4610可包括外层4611和内层4612。在某些实施例中,内层4612可包括限定在其中的多个凹坑(例如凹坑或腔4615),所述多个凹坑可有利于仓体4610的塌缩。在至少一个此类实施例中,内层4612可包括波纹形或蜂窝构型的点阵,所述点阵能够承受压缩力或压力,只要该压缩力或压力不超过特定的阈值即可。当未超过阈值时,内层4612可相对于所施加的压缩力或压力而以线性的或至少基本上线性的速率变形。在压缩力或压力超过阈值之后,内层4612可由于压缩负载而突然屈服于大挠曲并塌缩或弯曲。在各种实施例中,内层4612的点阵可由能够连接到一起的多个子层4612a构成。在至少一个实施例中,每个子层4612a可包括多个交替的沟与脊或波,所述多个交替的沟与脊或波可与相邻子层4612a的交替的沟与脊对齐。在至少一个此类实施例中,子层4612a的沟可被定位成与第二子层4612a的脊相邻;相似地,第一子层4612a的脊可被定位成与第二子层4612a的沟相邻。在各种实施例中,相邻的子层4612a可通过至少一种粘合剂(例如,纤维蛋白和/或蛋白水凝胶)相互粘附和/或粘附到外层4611。图88示出了在仓体4610已塌缩、且钉4620已变形以抵靠仓体4610而捕获并保持组织T之后的钉仓4600。
现在参见图89-91,在各种实施例中,钉仓(例如,钉仓4700)例如可包括可压缩植入式仓体4710以及定位在仓体4710中的多个钉4720。与上文相似,仓体4710可包括外层4711和内层4712,其中内层4712可包括多子层亚层4712a。同样与上文相似,每个子层4712a可包括交替的沟4717和脊4718,所述交替的沟和脊可相互对齐以在其间限定凹坑或腔4715。在至少一个此类实施例中,沟4717和/或脊4718可沿相互平行的和/或平行于纵向轴线4709的轴线延伸。在各种实施例中,钉4720可在多个钉排中对齐,所述多个钉排可沿相互平行的和/或平行于纵向轴线4709的轴线延伸。再次参见图87和图88,在各种可供选择的实施例中,仓体4600中所容纳的钉4620可沿轴线延伸,所述轴线横跨或垂直于由子层4612a的沟和脊所限定的轴线。再次参见图89-91,钉4720可延伸穿过沟4717和脊4718,其中钉4720与子层4712a之间的摩擦力可将钉4720保持在仓体4710中。在某些实施例中,所述多个子层4712a可由支撑材料和/或塑性材料(例如聚对二氧环己酮(PDS)和/或聚乙醇酸(PGA))构成,所述支撑材料和/或塑性材料可例如能够将钉4720保持在直立的取向、和/或将钉4720保持成相对于彼此对齐,如图89和图90所示。图91示出在仓体4710已塌缩、且钉4720已变形以抵靠仓体4710而捕获并保持组织T之后的钉仓4700。
再次参见图89-91,在各种实施例中,当仓体4710被压缩时,仓体4710可有回弹力地或以弹性方式塌缩。在至少一个此类实施例中,当仓体4710被压缩时,沟4717及脊4718在每个子层4712a中所形成的波可被平化或至少基本上被平化,此可使沟4717与脊4718之间所限定的腔体4715塌缩或至少基本上塌缩。在各种情况下,当从仓体4710移除压缩力或压力之后,仓体4710或仓体4710的至少多个部分可有回弹力地或以弹性方式再次伸展。在至少一个此类实施例中,当仓体4710被压缩时,相邻子层4712a的沟4717与脊4718之间的连接可保持未受损或至少基本上未受损,使得在从仓体4710上移除压缩力之后,子层4712a可偏置沟4717与脊4718本身使其远离彼此,并因此使仓体4710至少部分地再次伸展。在某些实施例中,当仓体4710被压缩时,其可以塑性方式变形或被压溃,因此在从仓体4710上移除压缩力或压力之后,仓体4710可不再次伸展。现在参见图92,在某些实施例中,钉仓(例如钉仓4800)例如可包括可压溃的仓体4810,该可压溃的仓体包括外层4811和内层4812,其中内层4812可包括波纹形的、蜂窝构型的点阵,所述点阵具有在其中限定的多个凹坑或腔4815。在各种实施例中,限定内层4812的点阵的壁可包括一个或多个弱化的或薄的横截面4819,所述一个或多个弱化的或薄的横截面4819能够容许限定点阵的壁在仓体4810被压缩时破裂。在这种情形中,当钉仓4800被植入时,仓体4810可被压溃。
现在参见图93-95,在各种实施例中,钉仓(例如,钉仓4900)例如可包括仓体4910,该仓体包括外层4911以及定位在外层4911的顶部与底部之间的多个可塌缩元件4912。首先参见图93和图94,钉仓4900还可包括多个钉4920,其中每个钉4920可被定位在可塌缩元件4912中。更具体地,每个可塌缩元件4912可包括第一部分4912a、第二部分4012b、和第三部分4012c,所述第一部分4912a、第二部分4012b和第三部分4012c可协作地在其中限定腔体4915,所述腔体能够容纳钉4920。在使用中,对上文进行进一步描述,钉仓4900可被定位在钉仓通道中并可对组织接触表面4919施加压缩力以压缩仓体4910。当组织接触表面4919向下运动时,可塌缩元件4912可塌缩。在这种情形中,每个可塌缩元件4912的第二部分4912b可塌缩至对应的第一部分4912a中;相似地,每个可塌缩元件4912的第三部分4912c可塌缩至对应的第二部分4912b中。当仓体4910被压缩且可塌缩元件4912塌缩时,位于可塌缩元件4912中的钉4920可变形,如图95所示。在各种实施例中,每个可塌缩元件4912的第二部分4912b可摩擦接合对应的第一部分4912a和/或压配于对应的第一部分4912a中,使得一旦对可塌缩元件4912施加的压缩力超过用于将第一部分4912a和第二部分4912b保持在其延伸位置(图94)中的保持力,则第一部分4912a和第二部分4912b可开始相对于彼此滑动。相似地,每个可塌缩元件4912的第三部分4912c可摩擦接合对应的第二部分4912b和/或压配于对应的第二部分4912b中,使得一旦对可塌缩元件4912施加的压缩力超过用于将第二部分4912b和第三部分4912c保持在其延伸位置(图94)中的保持力,则第二部分4912b和第三部分4912c可开始相对于彼此滑动。
在许多本文所述的实施例中,钉仓中可包括多个钉。在各种实施例中,此类钉可由变形为基本上U形构型并具有两个钉腿的金属线材构成。可设想出其中钉可包括不同构型(例如被接合在一起并具有三个或更多个钉腿的两个或更多个线材)的其他实施例。在各种实施例中,用于形成钉的一个或多个线材可包括圆的或至少基本上圆的横截面。在至少一个实施例中,钉线材可包括任何其他合适的横截面,例如正方形和/或矩形的横截面。在某些实施例中,钉可由塑料线材构成。在至少一个实施例中,钉可由涂覆有塑料的金属线材构成。在各种实施例中,除钉之外或作为钉的替代,仓可包括任何合适类型的紧固件。在至少一个此类实施例中,此类紧固件可包括可枢转的臂,所述臂在被砧座接合时会被折叠。在某些实施例中,可利用分为两部分的紧固件。在至少一个此类实施例中,钉仓可包括多个第一紧固件部分,并且砧座可包括多个第二紧固件部分;当砧座抵靠钉仓而被压缩时,第二紧固件部分连接到第一紧固件部分。在某些实施例中,如上所述,可在钉仓内推进滑动件或驱动器以便完成钉的成形过程。在某些实施例中,可在砧座内推进滑动件或驱动器,以便使一个或多个成形构件向下运动至与相对的钉仓及钉或位于钉仓中的紧固件接合。
在本文所述的各种实施例中,钉仓可包括存储于其中的四个钉排。在至少一个实施例中,所述四个钉排可被设置成两个内侧钉排和两个外侧钉排。在至少一个此类实施例中,内侧钉排及外侧钉排可被定位在钉仓内的切割构件或刀狭槽的第一侧上;相似地,内侧钉排和外侧钉排可被定位在切割构件或刀狭槽的第二侧上。在某些实施例中,钉仓可以不包括切割构件狭槽;然而,作为钉仓狭槽的替代,此类钉仓可包括能够被切割构件切开的指定部分。在各种实施例中,可将各内侧钉排设置在钉仓内,使得其与切割构件狭槽等距地或至少基本上等距地间隔开。相似地,可将各外侧钉排设置在钉仓内,使得其与切割构件狭槽等距地或至少基本上等距地间隔开。在各种实施例中,钉仓可包括多于或少于四个钉排存储在钉仓内。在至少一个实施例中,钉仓可包括六个钉排。在至少一个此类实施例中,钉仓可在切割构件狭槽的第一侧上包括三个钉排,并且在切割构件狭槽的第二侧上包括三个钉排。在某些实施例中,钉仓可包括奇数个钉排。例如,钉仓可在切割构件狭槽的第一侧上包括两个钉排,并且在切割构件狭槽的第二侧上包括三个钉排。在各种实施例中,钉排可包括具有相同或至少基本上相同的未成形钉高度的钉。在某些其他实施例中,一个或多个钉排可包括与其他钉具有不同的未成形钉高度的钉。在至少一个此类实施例中,例如切割构件狭槽的第一侧上的钉可具有第一未成形高度,并且切割构件狭槽的第二侧上的钉可具有第二未成形高度,所述第二未成形高度不同于所述第一高度。
现在参见图96A-96D,在各种实施例中,外科缝合器的端部执行器可包括:仓附接部(例如,钉仓通道5030);可移除地位于钉仓通道5030中的紧固件仓(例如,钉仓5000);以及与钉仓5000及钉仓通道5030相对地定位的钳口5040。钉仓5000可包括可压缩主体5010及多个钉5020、和/或至少部分地位于可压缩主体5010中的任何其他合适的紧固件。在至少一个此类实施例中,每个钉5020可包括基部5022以及从基部5022向上延伸的腿5021,其中腿5021的至少一部分可被嵌入仓体5010中。在各种实施例中,可压缩主体5010可包括顶部表面或组织接触表面5019及底部表面5018,其中底部表面5018可抵靠钉仓通道5030的支撑表面5031而定位并由支撑表面5031支撑。与上文相似,支撑表面5031例如可包括限定在其中的多个支撑狭槽5032(图96D),所述多个支撑狭槽5032能够容纳并支撑钉5020的基部5022。在各种实施例中,外科缝合器的端部执行器还可包括保持矩阵(例如保持矩阵5050),所述保持矩阵能够接合钉5020,并将组织捕获在保持矩阵与钉5020之间。在至少一个此类实施例中,保持矩阵5050能够可移除地安装到钳口5040。在使用中,一旦钉仓5000被定位在钉仓通道5030中,则钳口5040及附接到钳口5040的保持矩阵5050可朝钉仓5000和钉仓通道5030运动。在至少一个实施例中,钳口5040可沿轴线5099向下运动,使得当钳口5040闭合时,钳口5040及钉仓通道5030保持彼此平行或至少基本上平行。更具体地,在至少一个此类实施例中,钳口5040可被闭合,以使当钳口5040朝钉仓5000运动时,保持矩阵5050的组织接触表面5051平行于或至少基本上平行于钉仓5000的组织接触表面5019。
现在参见图96A,在各种实施例中,保持矩阵5050能够可分离地固定到钳口5040,使得当保持矩阵5050附接到钳口5040时,保持矩阵5050与钳口5040之间存在很小的(如果有的话)相对运动。在至少一个实施例中,钳口5040可包括一个或多个保持结构,所述一个或多个保持结构能够将保持矩阵5050保持就位。在至少一个此类实施例中,保持矩阵5050可搭扣配合和/或压配于钳口5040中。在某些实施例中,可利用至少一种粘合剂将保持矩阵5050粘附至钳口5040。在任何情形中,钳口5040可运动至如下位置中:其中保持矩阵5050接触组织T且组织T抵靠钉仓5000的组织接触表面5019而定位。当组织T被钳口5040定位成抵靠钉仓5000时,所述钉仓5000的可压缩主体5010可被钳口5040压缩或可不被其压缩。在任一种情形中,在各种实施例中,钉5200的腿5021可不穿过钉仓5000的组织接触表面5019突起,如图96A所示。此外,同样如图96A所示,在保留矩阵5050不接合钉5020的情况下,钳口5040能够抵靠可压缩主体5010来保持组织T。此类实施例可容许外科医生多次打开和闭合钳口5040,以便例如在不损坏组织T的情况下获得端部执行器在手术部位中的期望定位。然而,设想了其他实施例,其中钉末端5023能够在仓体5010被砧座5040压缩之前从组织接触表面5019突起。现在参见图96B,一旦端部执行器被恰当地定位,则钳口5040可朝钉仓通道5030向下运动,使得可压缩主体5010被砧座5040压缩,并使得组织接触表面5019相对于钉5020被向下推动。当组织接触表面5019被向下推动时,钉腿5021的末端5023可刺穿组织接触表面5019并刺穿组织T的至少一部分。在这种情形中,保持矩阵5050可被定位在钉5020上方,使得保持矩阵5050的保持孔5052与钉腿5021的末端5023对齐或至少基本上对齐。
现在参见图96C,当沿轴线5099向下推动保持矩阵5050时,钉5020的钉腿5021可进入保持孔5052中。在各种实施例中,钉腿5021可接合保持孔5052的侧壁。在某些实施例中,如下文所更详细描述,保持矩阵5050可包括延伸至保持孔5052中和/或围绕保持孔5052的一个或多个保持构件,所述一个或多个保持构件能够接合钉腿5021。在任一种情形中,钉腿5021可被保持在保持孔5052中。在各种情况下,钉腿5021的末端5023可进入保持孔5052中并可摩擦接合保持构件和/或孔5052的侧壁。当保持矩阵5050朝钉5020的基部5022被推动时,钉腿5021可相对于侧壁和/或保持构件滑动。由于上文所述,钉腿5021与保持矩阵5050之间可产生滑动摩擦力,其中此类滑动摩擦力可抵抗保持矩阵5050插入到钉5020上。在各种实施例中,当保持矩阵5050沿钉5020的钉腿5021向下滑动时,保持矩阵5050与钉5020之间的滑动摩擦力可为恒定的或至少基本上恒定的。在某些实施例中,由于例如钉腿5021、保持孔5052、和/或延伸至保持孔5052中和/或围绕保持孔5052的保持构件在几何形状上的变化;当保持矩阵5050沿钉腿5021向下滑动时,滑动摩擦力可增大和/或减小。在各种实施例中,钉仓5000的可压缩主体5010也可抵抗保持矩阵5050插入钉5020中。更具体地,可压缩主体5010可例如由弹性材料构成,所述弹性材料可对保持矩阵5050施加抗力;当可压缩主体5010被压缩的距离增大时,所述抗力增大。在至少一个此类实施例中,由仓体5010产生的抗力的增大可与仓体5010被压缩的距离线性地成比例或至少基本上线性地成比例。在某些实施例中,由仓体5010产生的抗力的增大可与仓体5010被压缩的距离几何地成比例。
在各种实施例中,对上文进行进一步描述,可对钳口5040和保持矩阵5050施加足够的击发力,以克服上述抗力及摩擦力。在使用中,保持矩阵5050可相对于钉5020被安放至任何合适的深度处。在至少一个实施例中,保持矩阵5050可相对于钉5020的基部5022被安放至一深度处,以便将两层或更多层组织固定到一起并在组织内产生压缩力或压力。在各种情况下,包括保持矩阵5050及钉5020的系统可容许外科医生通过选择保持矩阵5050被安放的深度来选择对组织施加的压缩力或压力的大小。例如,保持矩阵5050可朝钉5020的钉基部5022被向下推动,直至保持矩阵5050被安放至与支撑狭槽5032的底部相距特定深度5011,其中越浅的深度5011可产生施加至组织T的越高的压缩力或压力,而越深的深度5011可产生施加至组织T的越低的压缩力或压力。在各种实施例中,施加到组织T的压缩力或压力可与保持矩阵5050被安放的深度5011线性地成比例或至少基本上线性地成比例。在各种情况下,施加到组织T的压缩力或压力可取决于位于保持矩阵5050与钉仓5020之间的组织T的厚度。更具体地,对于给定的距离5011,较厚组织T的存在可比较薄组织T的存在产生更高的压缩力或压力。
在各种情况下,对上文进行进一步描述,外科医生可调整保持矩阵5050被安放的深度以导致位于端部执行器内的较厚和/或较薄的组织,并以与组织厚度无关的方式对组织T施加特定的或预定的压力。例如,当紧固较薄的组织T时,外科医生可将保持矩阵5050安放至较浅的深度5011,或当紧固较厚的组织T时将其安放至较深的深度5011,以便在组织内达到相同或至少基本上相同的压缩力。在某些实施例中,对上文进行进一步描述,外科医生可选择性地确定对位于保持矩阵5050与钉仓5010之间的组织T施加的压缩力的大小。在各种情况下,外科医生可将保持矩阵5050与钉5020接合,并将保持矩阵5050定位成与钉5020的基部5022相距第一距离,以便对组织施加第一压缩压力。作为另外一种选择,外科医生可将保持矩阵5050定位成与基部5022相距第二距离,所述第二距离短于所述第一距离,以便对组织施加大于第一压力的第二压缩压力。作为另外一种选择,外科医生可将保持矩阵5050定位成与基部5022相距第三距离,所述第三距离短于所述第二距离,以便对组织施加大于第二压力的第三压缩压力。在各种实施例中,包括保持矩阵5050及钉5020的紧固系统能够容许外科医生对靶组织施加宽范围的压缩压力。
现在参见图96D,在各种实施例中,钉腿5021可穿过保持矩阵5050而被插入,使得钉腿末端5023延伸至保持矩阵5050的顶部表面上方。再次参见图96C,在至少一个实施例中,钳口5040还可包括限定在其中的间隙孔5042,当钉腿末端5023穿过保持矩阵5050中的保持孔5052时,该间隙孔能够容纳钉腿末端5023。在至少一个此类实施例中,间隙孔5042可与保持孔5052对齐,使得腿5021不接触钳口5040。在各种实施例中,间隙孔5042可具有足够的深度,使得不论保持矩阵5050被安放的距离为何,钉腿5021均不接触钳口5040。现在参见图96D,在保持矩阵5050与钉5020接合并被安放到所需位置之后,钉仓通道5030及钳口5040可远离组织T运动。更具体地,钉仓通道5030可与所植入的钉仓5000分离,并且砧座5040可与所植入的保持矩阵5050分离。当钳口5040远离保持矩阵5050而行进且钉支撑件5032远离钉基部5022运动时,尽管钳口5040和钉仓通道5030不再对保持矩阵5050及基部5022提供支撑,然而仍可保持保持矩阵5050与基部5022的底部之间的距离5011。在各种实施例中,尽管被压缩的仓体5010和/或被压缩的组织T对保持矩阵5050施加偏置力,然而钉腿5021与保持矩阵5050之间的静摩擦力可足以将保持矩阵5050保持就位。在至少一个此类实施例中,仓体5010可由弹性材料构成,所述弹性材料在被压缩时可对保持矩阵5050和钉5020施加弹性偏置力,使得所述弹性偏置力趋于推动保持矩阵5050及钉5020以使其分开,然而此类运动受到钉腿5021与保持矩阵5050之间的摩擦接合的抵抗。
在各种实施例中,如上所述,保持矩阵可包括多个保持孔,其中每个保持孔能够在其中容纳紧固件的腿。在至少一个实施例中,现在参见图97,其中示出保持矩阵5150的一部分,该部分可包括由周边5156限定的保持孔5152。在各种实施例中,孔5152的周边5156可包括圆形或至少基本上圆形的外形和/或任何其他合适的外形。在某些实施例中,保持矩阵5150可包括一个或多个保持构件(例如保持构件5153),所述一个或多个保持构件延伸至孔5152中并能够当紧固件支腿插入孔5152中时,所述孔5152接合该紧固件支腿。在至少一个此类实施例中,每个保持构件5153可包括朝中心轴线5159(即,朝孔5152的中心)向内延伸的悬臂。在各种实施例中,每个悬臂可包括第一端部和第二端部,所述第一端部附接到保持矩阵主体5158,所述第二端部形成保持孔5152的周边5156。在某些实施例中,保持孔5152的周边5156可由第一直径或宽度限定,并且紧固件支腿可由第二直径或宽度限定,其中所述第二直径可大于所述第一直径。在至少一个此类实施例中,紧固件支腿能够接触保持构件5153中的一个或多个并使其挠曲,以便在紧固件支腿插入保持孔5152中时使保持孔5152的直径增大。在某些实施例中,对上文进行进一步描述,紧固件支腿所限定的周边可大于保持孔5152的周边5156,使得当紧固件支腿插入周边5156中时,紧固件支腿可使周边5156扩展。
再次参见图97,在各种实施例中,孔5152可由可变形构件5153限定,其中每个可变形构件5153能够相对于或独立于其他可变形构件5153挠曲。在至少一个此类实施例中,相邻的可变形构件5153可被狭槽5154分开,该狭槽能够容许每个可变形构件5153相对于其他可变形构件5153挠曲。在某些实施例中,每个狭槽5154可包括位于保持矩阵主体5158中的第一端部5155、通向保持孔5152的第二端部、以及在第一端部5155与第二端部之间延伸的恒定的或至少基本上恒定的宽度。在各种其他实施例中,每个狭槽5154的宽度可不一致,并且每个狭槽5154在其第一端部与第二端部之间的宽度可增大和/或减小。在某些实施例中,狭槽5154的第一端部5155可包括放大部分(例如圆形部分),所述放大部分既可为附接到保持矩阵主体5158的可变形构件5153的基部提供张力释放,也可增大可变形构件5153的柔性。在各种实施例中,可变形构件5153和/或狭槽5154的几何形状可被选择成为可变形构件5153提供期望的柔性。在某些实施例中,例如狭槽5154可被加长,以形成更长的可变形构件5153,该更长的可变形构件可比具有较短长度的可变形构件5153更具柔性。在至少一个实施例中,每个可变形构件5153的宽度可被选择成为其提供期望的柔性。更具体地,具有较薄宽度的可变形构件可比具有较厚宽度的可变形构件更具柔性。再次参见图97,在某些实施例中,可变形构件5153的悬臂的附接到保持矩阵主体5158的第一端部可宽于悬臂的第二端部。在至少一个此类实施例中,悬臂可在其第一端部与第二端部之间以线性或至少基本上线性的方式逐渐变细。
再次参见图97,在各种实施例中,保持矩阵主体5158可包括具有组织接触表面5151和顶部表面5157的平的或至少基本上平的材料片。在至少一个此类实施例中,组织接触表面5151与顶部表面5157可相互平行或至少基本上相互平行。在各种实施例中,每个可变形构件5153可包括第一部分5153a和第二部分5153b,其中第一部分5153a可沿第一方向延伸,并且第二部分5153b可沿不同方向或第二方向延伸。在至少一个此类实施例中,保持矩阵主体5158可限定平面,并且可变形构件5153的第一部分5153a可位于此平面内。在各种实施例中,可变形构件5153的第二部分5153b可相对于第一部分5153a成角度地延伸。在至少一个此类实施例中,第二部分5153b可沿远离保持矩阵主体5158的顶部表面5157的方向延伸,并且在某些实施例中,第二部分5153b可朝保持孔5152的中心轴线5159会聚。在任何情形中,在各种实施例中,当紧固件支腿穿过第二部分5153b而被插入时,第二部分5153b能够远离中心轴线5159挠曲。在其中钉5020的钉腿5021插入保持孔5152中的实施例中,可变形构件5153可沿大致远离钉5120的基部5122的方向变形。因此,在某些实施例中,可变形构件5153可沿与钉腿5021被插入的方向相同或至少基本上相同的大致方向挠曲。
再次参见图BD,在各种实施例中,可变形构件5153的第二部分5153b例如可各自包括锋利的末端,所述锋利的末端能够当钉腿5021插入其中时,所述末端抵靠钉腿5021滑动。如果钉腿5021沿相反方向(即,将钉腿5021从保持孔5052移除的方向)被牵拉,则第二部分5153b的尖锐末端也能够咬合至钉腿5021中。在某些情形中,第二部分5153b可相对于钉腿5021的边倾斜大于90度的角度,因此当钉腿5021受到趋于从保持孔5052中撤出钉腿5021的力时,第二部分5153b可挖入或掘入钉腿5021的边中。在某些实施例中,钉腿5021可在其表面中包括压痕和/或凹度(例如微压痕),所述压痕和/或凹度能够例如在其中容纳可变形构件5053的末端。在至少一个此类实施例中,当对钉腿5021施加撤出力时,可变形构件5053的末端可被困于或掘入钉腿5021的压痕中。在各种实施例中,由于第二部分5153b掘入钉腿5021中,为从保持孔5022中移除钉腿5021而作用的力可仅将第二部分5153b安放至钉腿5021中的更深处并增大移除钉腿5021期望的力。此外,由于第二部分5153b向上倾斜,因此在至少一个实施例中,第二部分5153b可更容许钉腿5021插入保持孔5152中且更抵抗钉腿5021的撤出。因此,在至少一个实施例中,将钉腿5021插入保持孔5022中期望的力可小于从保持孔5022中移除钉腿5021期望的力。在各种实施例中,例如从保持孔5022中移除钉腿5021期望的力可比将钉腿5021插入保持孔5022中期望的力大约50%。在各种其他实施例中,例如移除钉腿5021期望的力可比插入钉腿5021期望的力大约10%至大约100%之间。在某些实施例中,例如移除钉腿5021期望的力可为插入钉腿5021期望的力的大约100%、大约150%、大约200%、和/或比插入钉腿5021期望的力大约200%。
再次参见图97,在某些实施例中,第二部分5153b可围绕孔5152沿圆周设置并可在第二部分5153b与孔5152之间限定凹坑。更具体地,第二部分5153b可限定凹坑5160,该凹坑能够当紧固件支腿被插入保持孔5152中时,凹坑5160容纳紧固件支腿的末端。在各种实施例中,可变形构件5153的第二部分5153b可包括环形的或至少基本上环形的轮廓,所述轮廓例如可协作地限定凹坑1560的环形的或至少基本上环形的外形。在至少一个此类实施例中,第二部分5153b可限定锥形的或截锥形的凹坑。在各种实施例中,凹坑可由合适数目的可变形构件限定,例如四个可变形构件5153(图97)、六个可变形构件5153(图98)、或八个可变形构件5153(图99)。现在参见图100,在某些实施例中,保持矩阵(例如保持矩阵5250)的可变形构件例如可形成锥体形状或至少基本上为锥体的形状。在各种实施例中,保持矩阵5250例如可包括多个保持孔(例如保持孔5252),所述多个保持孔可由周边5256限定。在各种实施例中,周边5256可包括多边形的或至少基本上为多边形的外形和/或其他合适的外形。在某些实施例中,保持矩阵5250可包括一个或多个保持构件(例如保持构件5253),所述一个或多个保持构件延伸至孔5252中并能够当紧固件支腿插入孔5252中时,所述孔5252接合该紧固件支腿。在至少一个此类实施例中,每个保持构件5253可包括朝中心轴线5259(即,朝孔5252的中心)向内延伸的悬臂。在各种实施例中,每个悬臂可包括第一端部和第二端部,所述第一端部附接到保持矩阵主体5258,所述第二端部形成保持孔5252的周边5256。在某些实施例中,保持孔5252的周边5256可由第一直径或宽度限定,并且紧固件支腿可由第二直径或宽度限定,其中所述第二直径可大于所述第一直径。在至少一个此类实施例中,紧固件支腿能够接触保持构件5253中的一个或多个并使其挠曲,以便在紧固件支腿插入保持孔5252中时使保持孔5252的直径增大。在某些实施例中,对上文进行进一步描述,紧固件支腿所限定的周边可大于保持孔5252的周边5256,使得当紧固件支腿插入周边5256中时,紧固件支腿可使周边5256扩展。
再次参见图100,在各种实施例中,孔5252可由可变形构件5253限定,其中每个可变形构件5253能够相对于或独立于其他可变形构件5253挠曲。在至少一个此类实施例中,相邻的可变形构件5253可被狭槽5254分开,狭槽5254能够容许每个可变形构件5253相对于其他可变形构件5253挠曲。在各种实施例中,保持矩阵主体5258可包括具有组织接触表面5251及顶部表面5257的平的或至少基本上平的材料片。在至少一个此类实施例中,组织接触表面5251与顶部表面5257可相互平行或至少基本上相互平行。在各种实施例中,每个可变形构件5253可包括第一部分5253a和第二部分5253b,其中第一部分5253a可沿第一方向延伸,并且第二部分5253b可沿不同方向或第二方向延伸。在至少一个此类实施例中,保持矩阵主体5258可限定平面,并且可变形构件5253的第一部分5253a可位于此平面内。在各种实施例中,可变形构件5253的第二部分5253b可相对于第一部分5253a成角度地延伸。在至少一个此类实施例中,第二部分5253b可沿远离保持矩阵主体5258的顶部表面5257的方向延伸,并且在某些实施例中,第二部分5253b可朝保持孔5252的中心轴线5259会聚。在任何情形中,在各种实施例中,第二部分5253b能够当紧固件支腿穿过第二部分5253b而被插入时,第二部分5253b会远离中心轴线5259挠曲。再次参见图100,在某些实施例中,第二部分5253b可围绕孔5252沿圆周设置并可在第二部分与孔之间限定凹坑。更具体地,第二部分5253b可限定凹坑,当紧固件支腿被插入保持孔5252中时,所述凹坑能够容纳紧固件支腿的末端。在各种实施例中,可变形构件5253的第二部分5253b例如可限定多边形或至少基本上为多边形的凹坑。在各种实施例中,凹坑可由合适数目的可变形构件限定,例如可限定正方形的四个可变形构件5253(图100)、可限定六边形的六个可变形构件5253(图101)、或可限定八边形的八个可变形构件5253(图102)。
现在参见图103,在各种实施例中,保持矩阵(例如,保持矩阵5350)例如可由平的或至少基本上平的材料(例如,钛和/或不锈钢)薄片形成。在至少一个此类实施例中,可通过一个或多个冲压过程在保持矩阵5350的主体5358中形成多个孔5352。材料片可被定位在冲压模具中,所述模具在致动时可将材料的某些部分冲压出,以便形成例如狭槽5354、狭槽5354的孔5355、和/或保持孔5352的周边5356。冲压模具也能够将可变形构件5353弯曲成合适的构型。在至少一个此类实施例中,冲压模具可使第二部分5353b沿折线5353c相对于第一部分5353a向上变形。现在参见图104,在各种实施例中,保持矩阵(例如,保持矩阵5450)例如可包括多个保持孔5452。与上文相似,每个保持孔5452的周边5456可由被狭槽或狭缝5454间隔开的多个可变形构件5453限定。在至少一个此类实施例中,每个可变形构件5453的整体均可被向上弯曲,其中包括可变形构件5453的悬臂的自由端可限定周边5456。在各种实施例中,保持矩阵5450可包括围绕或至少基本上围绕保持孔5452的多个孔5455。在至少一个此类实施例中,孔5455可围绕或包围由可变形构件5453的悬臂的固定端限定的周边而被布置成圆形阵列。在某些实施例中,每个孔5455可包括圆形或至少基本上圆形的周边和/或任何其他合适的周边。在使用中,孔5455既可为附接到保持矩阵主体5458的可变形构件5453的基部提供张力释放,又可增大可变形构件5453的柔性。在各种实施例中,较大的孔5455与较小的孔5455相比可使可变形构件5453更具柔性。此外,更靠近可变形构件5453的孔5455与更远的孔5455相比可提供更大的柔性。
现在参见图105,在各种实施例中,保持矩阵(例如,保持矩阵5550)例如可包括多个保持孔5552。每个保持孔5552均可包括细长狭槽5554,该细长狭槽具有放大的圆形或至少基本上圆形的末端5555。在至少一个此类实施例中,末端5555可由宽于狭槽5554的直径限定。在某些实施例中,细长狭槽5554和末端5555可沿纵向轴线5559定位和/或居中。在各种实施例中,狭槽5554及末端5555可限定两个相对的插片5553,所述两个相对的插片5553能够接合紧固件的腿,并且在紧固件支腿穿过插片5553而被插入时,所述两个相对的插片5553会发生挠曲。在至少一个实施例中,具有越大周长或直径的末端5555可限定越长的插片5553,所述插片5553可比具有较小周长或直径的末端5555所限定的插片5553更具柔性。在各种实施例中,末端5555可具有相同的周长及直径,并且在至少一个此类实施例中,每个插片5553可关于与纵向轴线5559垂直或至少基本上垂直的轴线对称。作为另外一种选择,末端5555可具有不同的周长和/或直径,其中在至少一个实施例中,每个插片5553可不关于其轴线对称。在至少一个此类可供选择的实施例中,当紧固件支腿穿过保持孔5552而被插入时,插片5553可绕其轴线扭曲。现在参见图106,在各种实施例中,保持矩阵(例如,保持矩阵5650)例如可包括多个保持孔5652。每个保持孔5652均可包括细长狭槽5654,该细长狭槽包括圆形或至少基本上圆形的末端5655。在至少一个此类实施例中,细长狭槽5654及末端5655可沿纵向轴线5659定位和/或居中。在各种实施例中,每个末端5655均可由与狭槽5654的宽度相同或至少基本上相同的直径限定。
现在参见图107,在各种实施例中,保持矩阵(例如,保持矩阵5750)例如可包括多个保持孔5752。每个保持孔5752可包括具有放大末端5755的多个狭槽(例如狭槽5754)。在至少一个此类实施例中,狭槽5754及末端5755可沿纵向轴线5759定位和/或居中。在各种实施例中,轴线5759可沿垂直于或横向于彼此的方向延伸。在某些实施例中,狭槽5754和末端5755可例如限定四个插片5753,所述四个插片5753能够接合紧固件支腿,并且当紧固件支腿穿过保持孔5752而被插入时,所述四个插片5753发生挠曲。在至少一个实施例中,每个插片5753可包括三角形的或至少基本上为三角形的构型(例如等边三角形)。现在参见图108,在各种其他实施例中,保持矩阵(例如保持矩阵5850)例如可包括多个保持孔5852。每个保持孔5852可包括具有末端5855的多个狭槽(例如狭槽5854),其中狭槽5854和末端5855可沿纵向轴线5859定位和/或居中。在各种实施例中,轴线5859可沿垂直于或横向于彼此的方向延伸。在某些实施例中,狭槽5854及末端5855可限定插片5853,插片5853能够接合紧固件支腿,并且当紧固件支腿穿过保持孔5852而被插入时,插片5853发生挠曲。在至少一个实施例中,每个插片5853可包括弓形的外形。更具体地,与图105中所示的尖的末端不同,每个插片5853可包括弯曲的末端,所述末端能够接触紧固件支腿。
现在参见图109,在各种实施例中,保持矩阵(例如,保持矩阵5950)例如可包括多个保持孔5952。每个保持孔5952可包括多个狭槽(例如狭槽5954),其中每个狭槽5954可沿轴线5959延伸和/或居中。在各种实施例中,轴线5959可横向于彼此,并且在至少一个此类实施例中,轴线5959可被设置成使得所有轴线5959延伸穿过保持孔5952的中心且彼此等距地或至少基本上等距地间隔开。在至少一个实施例中,每个狭槽5954可包括面向保持孔5952的中心的开口端以及位于狭槽5954的相对末端处的第二或闭合端部5955。与上文相似,狭槽5954及末端5955可例如限定三个插片5953,所述三个插片5953能够接合紧固件支腿,并且当紧固件支腿穿过保持孔5952而被插入时,所述三个插片5953发生挠曲。在各种实施例中,每个插片5953可包括在狭槽5954的相邻末端5955之间延伸的弓形构型。现在参见图110,在各种实施例中,保持矩阵(例如,保持矩阵6050)例如可包括多个保持孔6052。每个保持孔6052可包括插片6053,所述插片能够接合紧固件支腿,并且当紧固件支腿被插入保持孔6052中时,插片6053发生挠曲。在至少一个此类实施例中,插片6053可包括固定到保持矩阵主体6058的基部以及包括弓形或弯曲外形6056的自由端,所述自由端能够接触紧固件支腿。在某些实施例中,紧固件支腿可为由圆形线材构成的钉腿,其中弯曲的外形6056能够与圆形线材的弯曲外表面匹配或至少基本上匹配。
再次参见图110,在各种实施例中,保持矩阵主体6058可包括多个狭槽6054和孔6055,所述多个狭槽6054和孔6055能够限定插片6053和保持孔6052的各个部分。在至少一个实施例中,插片6053可包括矩形构型,所述矩形构型包括平行的或至少基本上平行的边。现在参见图111,在某些实施例中,保持矩阵(例如保持矩阵6150)例如可包括多个保持孔6152。每个保持孔6152可包括插片6153,该插片能够接合紧固件支腿,并且当紧固件支腿被插入保持孔6152中时,该插片发生挠曲。在至少一个此类实施例中,插片6153可包括固定到保持矩阵主体6158的基部以及包括弓形或弯曲外形6156的自由端,所述自由端能够接触紧固件支腿。在各种实施例中,保持矩阵主体6158可包括多个狭槽6154及孔6155,所述多个狭槽6154及孔6155能够限定插片6153及保持孔6152的各个部分。在至少一个实施例中,插片6153可包括逐渐变细的构型,所述逐渐变细的构型包括弓形的边。在至少一个此类实施例中,插片6153可几何地逐渐变细,例如使得基部宽于自由端。
在各种实施例中,如上所述,紧固系统可包括多个钉,所述多个钉包括穿过保持矩阵中的多个保持孔而被插入的钉腿。在某些实施例中,如下文所更详细地描述,钉可被保持在第一钳口中,并且保持矩阵可被保持在第二钳口中,其中第一钳口与第二钳口中的至少一者可朝另一者运动。在各种情况下,位于第一钳口中的钉可被固定在其中,使得当保持矩阵与钉腿接合时,钉腿与保持孔对齐。参见图112和图113,在某些实施例中,紧固件系统可包括例如位于外科缝合器的第一钳口中的钉仓6200以及例如位于外科缝合器的第二钳口中的保持矩阵6250。现在参见图119和图120,对上文进行进一步描述,保持矩阵6250可包括多个保持孔6252,其中每个保持孔6252可包括由一个或多个可挠曲构件6253限定的周边6256。在至少一个此类实施例中,对上文进行进一步描述,用于限定每个孔6252的可挠曲构件6253可限定凹坑6201。在各种实施例中,每个凹坑6201可包括例如弯曲和/或凹形表面,所述弯曲和/或凹形表面例如能够在钉腿与保持孔6252未对齐并首先接触可挠曲构件6253和/或组织接触表面6251的情形中将钉腿的末端引导至孔6252中。
在各种实施例中,对上文进行进一步描述,紧固系统还可包括多个钉6220,所述多个钉6220包括可穿过保持矩阵6250中的保持孔6252而被插入的钉腿6221。在至少一个此类实施例中,每个钉6220可包括例如基本上为U形的构型,所述构型包括基部6222,所述钉腿6221可从基部6222向上延伸。现在参见图115和图116,在各种实施例中,保持矩阵6250中的保持孔6252可被布置成例如两个平行的或至少基本上平行的纵行,所述纵行可沿保持矩阵的纵向轴线或平行于所述纵向轴线延伸。在某些实施例中,第一排中的保持孔6252可相对于第二排中的保持孔6252偏置或错列。在至少一个此类实施例中,每个钉6220可包括位于第一排的保持孔6252中的第一钉腿6221以及位于第二排的保持孔6252中的第二钉腿6221,因此基部6222可沿横跨保持矩阵6250的纵向轴线的方向延伸。在至少一个此类实施例中,钉6220可相互平行或至少基本上相互平行。更具体地,例如钉6220a的基部6222a可平行于或至少基本上平行于钉6220b的基部6222b,所述钉6220b的基部6222b可平行于或至少基本上平行于钉6220c的基部6222c。在至少一个实施例中,例如钉6220a的钉腿6221a所限定的平面可平行于或至少基本上平行于钉6220b的钉腿6221b所限定的平面,并且钉6220b的钉腿6221b所限定的平面可平行于或至少基本上平行于钉6220c的钉腿6221所限定的平面。
现在参见图112和图114,在各种实施例中,钉仓6200可包括多个钉6220以及包括多个对齐引导件(例如,狭槽、沟槽和/或孔)的对齐矩阵6260,所述多个对齐引导件能够对齐钉6220。在各种情况下,对齐矩阵6260能够使得在保持矩阵6250接合钉腿6221之前,钉6220的钉腿6221与保持矩阵6250中的保持孔6252对齐。现在参见图117和图118,在各种实施例中,对齐矩阵6260可包括多个对齐孔6262,所述多个对齐孔能够紧密地容纳钉6220的钉腿6221。在至少一个此类实施例中,每个钉6220可包括基部6222以及从基部6222延伸的两个钉腿6221,其中钉6220的基部6222可围绕保持矩阵6260的底部表面6264延伸,并且钉腿6221可穿过对齐孔6262而向上延伸。在某些实施例中,每个对齐孔6262可为圆形的或至少基本上圆形的,并且限定对齐孔6262的直径可等于或稍大于穿过其中而延伸的钉腿6221的直径。在各种实施例中,对齐矩阵6260还可包括多个凸起的构件6263,所述多个凸起的构件可从对齐矩阵6260的顶部表面6261向上延伸并围绕或至少部分地围绕对齐孔6262。在某些实施例中,凸起的构件6263可提供更长的对齐孔6262,其中在各种情况下,较长的孔6262可比较短的孔6262更好地控制钉腿6221的对齐。
在使用中,在各种实施例中,支撑钉仓6200的第一钳口可位于将被缝合的组织的一侧上,并且支撑保持矩阵6250的第二钳口可被定位在组织的另一侧上。在某些实施例中,一旦钳口相对于组织被适当地定位,则第二钳口及保持矩阵6250可朝钉仓6200运动。在各种实施例中,当钉腿6221穿过保持矩阵6250的保持孔6252而被插入时,保持矩阵6250的组织接触表面或底部表面6251可接触组织并将组织压抵于对齐矩阵6260的组织接触表面或顶部表面6261上。在各种其他实施例中,如下文将更详细地描述,钉仓6200还可例如包括位于对齐矩阵6260的顶部表面6261上方并可接触组织的可压缩仓体。再次参见图114和图118,在某些实施例中,对齐矩阵6260还可包括限定在其中的一个或多个孔6203;当对齐矩阵6260抵靠组织而定位时,所述一个或多个孔能够在其中容纳组织的一部分。在其中可压缩仓体位于对齐矩阵6260上方和/或抵靠对齐矩阵6260的实施例中,当仓体被压缩时,可压缩仓体的一部分可进入孔6203中。相似地,保持矩阵6250可包括多个孔6202,当保持矩阵6250抵靠组织而定位时,所述多个孔6202能够在其中容纳组织的至少一部分。
对上文进行进一步描述,当钉6220的钉腿6221穿过保持矩阵6250的保持孔6252而被插入时,钉腿6221的末端可从保持矩阵6250的顶部表面6257向上突起。在各种情况下,如上所述,钉腿6221的末端可在穿过保持孔6252而被插入之后保持未弯曲。现在参见图121-124,在某些实施例中,包括钉仓6200及保持矩阵6250的紧固系统可包括多个保护帽或盖(例如帽6270),所述多个保护帽或盖可安装至突起于保持矩阵6250上方的钉腿6221。在各种实施例中,每个帽6270可完全或至少部分地覆盖钉腿6221的尖锐末端,使得所述尖锐末端不会接触与其相邻的组织。现在参见图124,在至少一个实施例中,每个帽6270可包括限定在其中的孔6271,该孔能够在其中紧密地容纳钉腿6221的末端。在各种实施例中,帽6270可由弹性材料(例如硅氧烷、聚异戊二烯、Sanoprene、和/或天然橡胶)构成。在至少一个实施例中,孔6271的周长或直径可小于插入其中的钉腿6221的周长或直径。在至少一个此类实施例中,保护帽6270中的孔6271可扩展以在其中容纳钉腿6221。在各种可供选择的实施例中,帽6270可不包括孔,并且当腿6221插入帽6270时,钉腿6221的末端能够切开帽6270。在任何情形中,在各种实施例中,每个帽6270均可被安放至钉腿6221上,直至帽6270的基部6272邻接或邻近保持矩阵6250的顶部表面6257而定位。在各种情况下,帽6270能够使得其被紧密地安放至钉腿6221的末端上,以使其不会轻易地从所述末端上被移除。在某些实施例中,每个帽6270可例如包括锥形的或至少基本上锥形的外表面。在各种实施例中,帽6270可包括任何合适的形状,例如包括抛物线形或至少基本上抛物线形的外表面的形状。
在各种实施例中,例如可使用图125-127中所示的外科缝合器来部署例如上述紧固件系统。在各种实施例中,端部执行器可包括第一钳口或钉仓通道6230和第二钳口6240,第一钳口或钉仓通道6230能够将钉仓6200支撑在其中,并且第二钳口6240能够支撑保持矩阵6250及所述多个保护帽6270。首先参见图125,其示出处于打开构型的第二钳口6240,钳口6230和6240可相对于组织T被定位成使得组织T位于保持矩阵6250与钉仓6200之间。在各种实施例中,如上所述,钉仓6200还可包括可压缩仓体(例如仓体6210),所述可压缩仓体中可定位有钉6220和对齐矩阵6260。在至少一个此类实施例中,组织T可抵靠仓体6210的顶部表面而定位。在某些实施例中,第二钳口6240可包括多个凹陷部或孔6245以及一个或多个保持结构或保持器,所述多个凹陷部或孔6245能够容纳多个保护帽6270,并且所述一个或多个保持结构或保持器能够相对于帽6270将保持矩阵6250保持就位。在至少一个此类实施例中,保持矩阵6250能够将帽6270保持在孔6245中。现在参见图137,在各种实施例中,每个孔6245均能够将帽6270的一部分或全部容纳在其中。在某些实施例中,孔6245的尺寸被足够地设定成且能够例如使得可通过压配和/或搭扣配合结构中的至少一者将帽6270固定在孔6245中。在某些实施例中,可利用至少一种粘合剂来将帽6270固定在孔6245中。在至少一个此类实施例中,此类粘合剂可被选择成使得在帽6270接合钉腿6221且第二钳口6240远离已植入的紧固件组件运动之后,帽6270可与第二钳口6240分离。现在参见图138,在某些实施例中,第二钳口6240还可包括至少一个覆盖片6246,所述至少一个覆盖片可组装至第二钳口6240并可在帽6270上方延伸且将帽6270保持在孔6245中。在至少一个此类实施例中,例如可利用至少一种粘合剂将覆盖片6246的至少一部分固定到钳口6240。在使用中,在至少一个实施例中,在端部执行器被插入手术部位之前,覆盖片6246可至少部分地与钳口6240分离。在某些实施例中,覆盖片6246可由植入式材料(例如PDS和/或PGA)构成,当钉腿6221从保持矩阵6250显示时,所述植入式材料可被钉腿6221切开。在至少一个此类实施例中,覆盖片6246可在盖6270与保持矩阵6250之间被固定在紧固系统中。
现在参见图126,对上文进行进一步描述,钳口6240可从打开位置运动到闭合位置,在闭合位置中,组织T抵靠保持矩阵6250及仓体6210而定位。在此类位置中,保持矩阵6250可不接合钉6220。在各种实施例中,钳口6240可通过致动器6235而在其打开位置与其闭合位置之间运动。在至少一个此类实施例中,钳口6240可包括从其延伸的远侧销6243和近侧销6244,其中远侧销6243可在限定在仓通道6230中的远侧狭槽6233内垂直地或至少基本上垂直地滑动,并且其中近侧销6244可在同样限定在钉仓通道6230中的近侧狭槽6234内垂直地或至少基本上垂直地滑动。在使用中,致动器6235可朝近侧缩回,以将销6243和6244驱动至其相应的狭槽6233和6234的上端中,如图126所示。在至少一个此类实施例中,致动器6235可包括远侧驱动狭槽6236和近侧驱动狭槽6237,其中驱动狭槽6236和6237的侧壁能够分别接触远侧销6243和近侧销6244,并在致动器6235朝近侧运动时向上驱动销6243和6244。更具体地,当致动器6235朝近侧运动时,远侧销6243可使远侧驱动狭槽6236的倾斜的第一部分6236a向上滑动至中间部分或第二部分6236b中;相似地,近侧销6244可使远侧驱动狭槽6237的倾斜的第一部分6237a向上滑动至中间部分或第二部分6237b中。当销6243和6244两者均向上运动时,钳口6240可朝组织T向下旋转至闭合位置。
现在参见图127,对上文进行进一步描述,致动器6235可进一步朝近侧被拉动,以朝第一钳口6230向下推动第二钳口6240、压缩仓体6210、并使保持矩阵6250及多个保护帽6270与钉6220的钉腿接合。在至少一个此类实施例中,致动器6235的附加的近侧运动可使驱动狭槽6236和6237的侧壁分别接触销6243和6244,并分别朝狭槽6233和6234的底端向下驱动销6243和6244。在这种情形中,致动器6235可朝近侧被牵拉,使得远侧销6243离开驱动狭槽6236的第二部分6236b并进入倾斜的第三部分6236c,并且相似地,近侧销6244离开驱动狭槽6237的第二部分6237b并进入倾斜的第三部分6237c。当销6243和6244两者均向下运动时,第二钳口6240可朝第一钳口6230向下运动至击发位置。在至少一个此类实施例中,第二钳口6240可向下运动,使得保持矩阵6250保持平行于或至少基本上平行于仓体6210的顶部表面和/或平行于或至少基本上平行于对齐矩阵6260。在任何情形中,一旦保持矩阵6250及保护帽6270接合钉6220的钉腿6221,如图129所示,则第二钳口6240可返回至打开的或至少基本上打开的位置。在至少一个此类实施例中,致动器6235可朝远侧被推动,以将销6243和6244分别驱动至狭槽6233和6234的末端,并且随后一旦销穿过相应的驱动狭槽6236和6237的中间部分6236b和6237b,则致动器6235朝狭槽6233和6234的底端被向下驱动。一旦第二钳口6240被打开,则第一钳口6230可与已植入的钉仓6200分离,并且第一钳口6230和第二钳口6240可从已植入的紧固件组件移除,如图128所示。
再次参见图127,读者应注意,尽管保持矩阵6250和帽6270已接合钉腿6221,然而图中并未将销6243及6244示出为被安放于其相应狭槽6233及6234的最底部中。当厚组织T位于保持矩阵6250与仓体6210之间时会发生这种情形。现在参见图130,在其中较薄组织T位于保持矩阵6250与仓体6210之间的情形中,销6243和6244可进一步被向下驱动至其相应的狭槽6233和6234中,如图132所示。一般来讲,在至少一个此类实施例中,致动器6235可朝近侧被牵拉,以便通过上述和图130-132所示的进程来向上及向下驱动销6243和6244,并且由于组织T较薄,保持矩阵6250及保护帽6270可进一步被驱动至钉6220的钉腿6221上,如图133和图134所示。在各种实施例中,由于保持矩阵6250所提供的可调整性,无论捕获在端部执行器内的组织是厚的还是薄的,均可在所紧固的组织中获得相同的或至少基本上相同的压缩压力。在某些实施例中,保持矩阵6250所提供的可调整性可容许外科医生通过选择保持矩阵6250被安放的深度来选择对组织施加较大的压缩压力还是较小的压缩压力。在至少一个此类实施例中,保持矩阵6250可被安放至钉腿6221上的范围例如可通过狭槽6233和6234的长度或范围确定。
在各种实施例中,如上所述,保护帽6270可由例如能够抓紧钉腿6221的末端的柔软的或柔性的材料构成。在某些实施例中,保护帽6270可由可生物吸收的塑料(例如以商品名Vicryl出售的聚乙醇酸(PGA)、聚乳酸(PLA或PLLA)、聚对二氧环己酮(PDS)、聚羟基链烷酸酯(PHA)、以商品名Monocryl出售的聚卡普隆25(PGCL)、聚己内酯(PCL)、和/或PGA、PLA、PDS、PHA、PGCL、和/或PCL的复合物)和/或生物相容性金属(例如钛和/或不锈钢)构成。如图124所示,在至少一个实施例中,每个帽6270可不连接至其他帽6270。在某些其他实施例中,一个或多个帽6270可被安装至保持矩阵6250。在至少一个此类实施例中,帽6270可例如通过至少一种粘合剂连接到保持矩阵6250,其中帽6270中的孔6271可与保持矩阵6270中的保持孔6252对齐或至少基本上对齐。现在参见图135,在各种实施例中,保护帽(例如帽6370)例如可限定内腔或穹窿6374,内腔或穹窿6374例如能够将钉腿6221的末端容纳在其中。在至少一个此类实施例中,帽6370可包括底部6372和延伸穿过底部6372的孔6371。在各种实施例中,孔6371可由一个或多个可挠曲的构件6373限定,当钉腿6221穿过其中而被插入时,所述一个或多个可挠曲的构件6373可发生挠曲。在某些实施例中,例如两个或更多个帽6370可连接在一起以形成帽6370的阵列。现在参见图136,在至少一个此类实施例中,多个帽6370可通过材料片6375而连接在一起。在某些实施例中,片6375可具有足够的刚性以便保持帽6370的期望的排列和/或对齐方式。在至少一个实施例中,帽6370可由生物相容性金属(例如钛和/或不锈钢)构成,并且片6375可由可生物吸收的塑料(例如以商品名Vicryl出售的聚乙醇酸(PGA)、聚乳酸(PLA或PLLA)、聚对二氧环己酮(PDS)、聚羟基链烷酸酯(PHA)、以商品名Monocryl出售的聚卡普隆25(PGCL)、聚己内酯(PCL)、和/或PGA、PLA、PDS、PHA、PGCL、和/或PCL的复合物)构成。在各种实施例中,片6375可由其中存储和/或分散有抗菌剂(例如胶体银和/或三氯生)的可生物吸收的材料构成,例如在片6375被生物吸收时,所述抗菌剂可被释放。
在各种实施例中,对上文进行进一步描述,例如可利用注塑方法将片6375注塑于帽6370周围,使得帽6370被嵌入片6375中。在某些其他实施例中,例如可利用注塑方法来模制片6375,其中例如在注塑方法期间和/或注塑方法之后,可利用冲压方法在片6375中形成孔6376。在任一种情形中,可将帽6370插入孔6376中并利用压配和/或搭扣配合互连方法和/或至少一种粘合剂将其固定在孔6376中。在某些实施例中,每个帽6370可包括围绕或至少部分地围绕帽6370周边的环形沟槽,所述环形沟槽能够将孔6376的周边容纳在其中。在某些实施例中,片6375可由能够容许帽6370之间进行相对运动的柔性和/或柔韧材料构成。在至少一个此类实施例中,柔性片6375可由例如橡胶、塑料、和/或硅氧烷材料构成,并且帽6370可由刚性材料(例如金属)构成。在至少一个此类实施例中,与上文相似,可将柔性材料模制于帽6370周围。在某些实施例中,例如可将帽6370按压至预先模制的片6375中。在各种实施例中,可将柔性材料的硬度选择成提供片6375期望的刚度。在某些实施例中,片6375可被构造成包括柔性的带。在任何情形中,片6375可有利于将帽6370组装至端部执行器中,这是因为可同时将多个帽6370定位和/或对齐于端部执行器中。此外,用于连接帽6370的片6375一旦被植入,则可例如沿钉行来强化或支持钉。除用于连接帽6370的薄片之外或作为所述薄片的替代,帽6370可通过多个链节连接在一起。在至少一个此类实施例中,此类链节可为柔性的并可容许帽6370之间进行相对运动。
现在参见图139和图140,在各种实施例中,保护帽(例如,帽6470)可包括成形表面,所述成形表面能够使钉腿的末端变形。在至少一个此类实施例中,帽6470可包括基部6472,该基部可包括延伸穿过其中的孔6471。在各种实施例中,孔6471能够将钉腿(例如钉腿6221)紧密地容纳在其中。在至少一个此类实施例中,限定孔6471的直径或周长可等于或大于钉腿6221的直径或周长。在各种实施例中,帽6470还可包括腔或穹窿6474,该腔或穹窿能够当钉腿6221被插入帽6470中时容纳钉腿6221的末端。首先参见图140,帽6470还可包括砧座或成形表面6473,该砧座或成形表面能够使钉腿6221挠曲并变形。在某些情形中,成形表面6473例如可为弯曲的和/或凹形的,并能够当钉腿6221被插入帽6470时使钉腿6221卷曲。在某些实施例中,钉腿6221可被充分地变形以使其无法穿过孔6471而被撤出,因此帽6470可被锁定至钉腿6221。在至少一个此类实施例中,帽6470的基部6472可限定围绕孔6471而延伸的唇缘,所述唇缘可防止已变形的钉腿6221从腔6474中被移除。在各种情况下,由于上文所述,一个或多个帽6470可防止或抑制保持矩阵(例如保持矩阵6250)从钉6220倒退或脱离。在各种实施例中,尽管未示出,然而帽6470可对称地或至少基本上对称地形成,并且孔6471可沿穿过帽6470延伸的中心轴线6479定位。再次参见图139,在各种可供选择的实施例中,孔6471可相对于中心轴线6479偏置。在至少一个此类实施例中,偏置的孔6471可容许钉腿6221接触成形表面6473的一侧并卷曲到成形表面6473的另一侧,而不是接触成形表面6473的中心,如在上述包括居中设置的孔6471的实施例中可能发生的一样。
在各种实施例中,如上所述,保持矩阵(例如,保持矩阵6250)可由材料片及穿过所述材料片而延伸的多个保持孔6252构成。在至少某些实施例中,构成保持矩阵6250的材料片可为刚性的或基本上不可挠曲的。在某些其他实施例中,保持矩阵可由保持矩阵元件的阵列以及用于连接所述保持矩阵元件的多个柔性连接件或链节构成。现在参见图141,在各种实施例中,保持矩阵或保持矩阵6550的一部分可包括多个元件主体6505,所述多个元件主体可由一个或多个连接链节6507连接在一起。在至少一个实施例中,每个元件主体6505均可包括多个可变形构件6553,所述多个可变形构件可在其中限定保持孔6552。在某些实施例中,保持矩阵6550的元件主体6505及连接链节6507可形成为一体并可包括一体式材料块。在各种实施例中,保持矩阵6550可例如由金属材料(例如钛和/或不锈钢)冲压或浇铸而成。在至少一个实施例中,保持矩阵6550可由塑料构成,例如聚醚醚酮(PEEK)、以商品名普理灵(Prolene)出售的聚丙烯、聚酯、以商品名Ethibond和Mersilene出售的聚对苯二甲酸乙二醇酯、聚偏二氟乙烯、聚偏二氟乙烯-共-六氟丙烯、以商品名Pronova出售的聚六氟丙烯-VDF、和/或以商品名Ethilon和Nurolon出售的长链脂肪族聚合物尼龙6和尼龙6,6,并且可通过例如注塑方法形成。在某些实施例中,元件主体6505可不与连接链节6507形成一体。在各种实施例中,可产生多个单一的元件主体6505,所述多个单一的元件主体6505随后被连接在一起并被嵌入保持矩阵中。在至少一个此类实施例中,元件主体6505可由金属材料(例如钛和/或不锈钢)冲压而成并被放置在塑料注射模具中,其中可将塑性材料注入模具中以形成围绕或至少部分地围绕元件主体6505的边缘6506以及从边缘6506延伸的连接链节6507。在某些其他实施例中,一个或多个连接件点阵可被形成为包括限定在多个边缘6506中的孔,其中每个此类孔均能够将元件主体6505容纳在其中。在至少一个实施例中,每个元件主体6505可包括圆形的或至少基本上为圆形的外周边;相似地,每个边缘6506中可限定有圆形的或至少基本上为圆形的孔,其中所述孔的直径可等于或小于元件主体6505的直径。在至少一个此类实施例中,元件主体6505可压配或嵌入边缘6505中的孔中。在某些实施例中,可利用至少一种粘合剂将元件主体6505固定在孔中。
在某些实施例中,对上文进行进一步描述,保持矩阵可包括多个元件主体6505以及多个连接链节6507,所述多个连接链节6507可以任何合适的阵列(例如,图142-145所示的那些)来连接元件主体6505。不论阵列的图案为何,在各种实施例中,连接链节6507能够容许元件主体6505与保持孔6552相对于彼此进行运动。在至少一个此类实施例中,构成保持矩阵6550的元件主体6505及连接链节6507的点阵一旦与组织接合便能够拉伸、扭曲、塌缩、和/或换句话讲挠曲,以便容许组织内的至少一些运动而同时抵抗组织进行较大的运动。在各种实施例中,每个连接链节6507可包括柔性构件,所述柔性构件能够拉伸、扭曲、和/或塌缩,以便例如容许保持矩阵6550在保持矩阵元件6505之间挠曲。再次参见图141,限定从边缘6506延伸的每个链节6507的宽度可窄于元件主体6505和/或边缘6506的宽度。参见图142-145,在某些实施例中,一个或多个链节6507可包括直的部分,所述直的部分例如沿相邻的元件主体6506之间的线延伸。在至少一个此类实施例中,每个链节6507可包括附接到第一边缘6506的第一端部和附接到第二边缘6506的第二端部。再次参见图141,在某些实施例中,两个或更多个链节6507可彼此连接。在至少一个此类实施例中,例如两个或更多个链节6507可被连接于中间铰链6509处。在各种实施例中,例如铰链6509的横截面厚度与链节6507的横截面厚度相比可沿一个或多个方向减小,这可容许相连的链节6507相对于彼此运动。在某些实施例中,保持矩阵6550还可包括铰链6508,铰链6508可将链节6507连接到边缘6506并容许链节6507与边缘6506之间相对运动。与铰链6509相似,例如铰链6508的横截面厚度与链节6507的横截面厚度相比可沿一个或多个方向减小。
在各种实施例中,对上文进行进一步描述,相连的链节6507可沿不同的方向延伸。在至少一个此类实施例中,第一链节6507可沿第一方向延伸,并且第二链节6507可沿第二方向延伸,其中所述第一方向可不同于所述第二方向。在某些实施例中,第一链节6507可沿第一行延伸,并且第二链节6507可沿第二行延伸,其中所述第一行与所述第二行可成角度(例如大约30度、大约45度、大约60度、和/或大约90度)地相交。在各种实施例中,铰链6508和/或铰链6509可包括活动铰链,所述活动铰链可容许链节6507相对于彼此多次运动而不会断裂。在某些实施例中,铰链6508和/或铰链6509可包括易碎或易断裂的部分,所述易碎或易断裂的部分可在过度挠曲和/或过多次数地挠曲时断裂。在至少一个此类实施例中,此类易碎部分可容许保持矩阵6550的一个或多个部分与保持矩阵6550的另一部分断开。在各种实施例中,铰链6508和/或铰链6509例如可包括保持矩阵6550的比保持矩阵6550的其他部分更容易切割的段。更具体地,已植入的保持矩阵及由已植入的保持矩阵紧固的组织可时常出于各种原因被切割构件切开,并且为了有利于进行此类横切,铰链6508和/或铰链6509例如可提供途径或薄层,切割构件可穿过所述途径或薄层更容易地穿过保持矩阵6550。在各种实施例中,对上文进行进一步描述,连接链节6507可包括例如限定在其中的一个或多个铸造结构或材料镦锻,所述一个或多个铸造结构或材料镦锻可有利于连接链节6507的弯曲、断裂、和/或切割。
在各种实施例中,保持矩阵可包括多个保持矩阵元件(例如,矩阵元件主体6505),所述多个保持矩阵元件可嵌入柔性材料片或材料带中。在至少一个实施例中,柔性材料片可由可生物吸收的弹性体材料(例如硅氧烷)形成,其中所述柔性薄片可产生有限定在其中的多个孔。在至少一个此类实施例中,可模制出实心的柔性薄片并在所述柔性薄片中穿孔形成多个孔。在各种可供选择的实施例中,可模制柔性薄片并在模制过程中形成限定在其中的孔。在任一种情形中,保持矩阵元件6505例如可被插入并保持在柔性薄片中。在某些其他实施例中,与上文相似,柔性薄片可形成于矩阵元件6505周围。在至少一个实施例中,柔性薄片可例如由机织网和/或任何其他合适的材料构成。对上文进行进一步描述,此类机织网可易于横切。
现在参见图146和图147,在各种实施例中,包括保持矩阵(例如,保持矩阵6250)的紧固件系统还可包括盖(例如,盖6670),当钉腿6221的末端延伸至保持矩阵6250的顶部表面6257上方时,所述盖可覆盖所述末端。在各种实施例中,盖6670可附接到保持矩阵6250。在某些实施例中,盖6670和/或保持矩阵6250可包括保持结构,所述保持结构能够将盖6670保持到保持矩阵6250。在至少一个实施例中,可利用至少一种粘合剂将盖6670粘附到保持矩阵6250。在至少一个实施例中,盖6670可由单个层构成,然而盖6670被示出为包括两个层,如下文所更详细地描述。在各种实施例中,首先参见图147,钉腿6221的末端可延伸穿过盖6670的底部表面6673;然而,盖6670可包括足够的厚度,使得钉末端不延伸穿过盖6670的顶部表面6675。因此,在至少一个此类实施例中,钉腿6221的末端可不从盖6670突起。在各种实施例中,盖6670可包括多个层。在至少一个此类实施例中,盖6670可包括第一层6671和第二层6672。在至少一个实施例中,第一层6671和第二层6672可相互附接,其中在至少一个实施例中,第二层6672可包括附接到第一层6671的底部表面6676。在各种实施例中,第一层6671和第二层6672可包括不同的厚度,而在某些实施例中,其可包括相同的厚度。在至少一个实施例中,第一层6671和第二层6672可包括基本上相同的宽度和/或长度。在可供选择的实施例中,层6671和6672可包括不同的宽度和/或长度。
在各种实施例中,对上文进行进一步描述,第一层6671可由能够被钉腿6211切开的可压缩泡沫、网状材料、和/或水凝胶构成。在至少一个实施例中,第二层6672可由更坚韧的材料或皮肤(例如PGA和/或PDS)和/或任何合适的支撑材料构成。在至少一个此类实施例中,钉腿6221能够穿透第一层6671;然而,在各种实施例中,钉腿6221可能无法穿透第二层6672。在某些实施例中,第二层6672可由具有足够弹性和/或韧性的材料构成,所述材料可容许第二层6672被钉腿6221接触并移位,但不被钉腿6221的钉末端切割或仅被少量地切割。尽管图中未示出,然而盖可包括不止两个层,其中这些层中的一个或多个可为防刺穿的。在至少一个此类实施例中,在使用中,保持矩阵6250可抵靠组织定位以被紧固并朝远侧推动,使得钉6220的钉腿6221穿过组织T及保持矩阵6250中的保持孔6252而被推动,并进入盖6270的第一层6271中。在各种实施例中,钉腿6221的末端可不进入或至少基本上不进入盖6270的第二层6272中。在保持矩阵6250被适当地定位之后,钳口6240可被打开,并且盖6670及保持矩阵6250可与钳口6240分离,如图146所示。如图146所示,钳口6640能够保持不止一个保持矩阵6250及盖6670。在至少一个此类实施例中,钳口6640可包括两个通道6679,所述两个通道6679可分别能够在其中容纳盖6670以及相对于盖6670定位的保持矩阵6250,使得每个保持矩阵6250的组织接触表面6251从钳口6240的底部向悬垂。在至少一个此类实施例中,保持矩阵6250及盖6270可在刀狭槽6678的每个侧上容纳在钳口6640中。在使用中,保持矩阵6250及盖6670两者可同时被部署和/或相对于穿过其而定位的相对的钉仓(例如仓6200)被部署于相同的深度处。随后,在各种实施例中,可由横贯刀狭槽6678的切割构件沿切割线切开被紧固的组织,其中钳口6640可随后被再次打开。在某些实施例中,盖6670可不附接到保持矩阵6250。在至少一个此类实施例中,盖6670可被定位在通道6679中并可通过能够被固定到钳口6640的保持矩阵6250而被保持在通道6679中。在各种实施例中,每个保持矩阵6250可宽于和/或长于其相应的盖6670,使得保持矩阵6250可将其盖6670的整体保持就位。在某些实施例中,每个保持矩阵6250可例如与其相应的盖6670包括相同的宽度和/或长度。
在各种实施例中,如上所述,紧固件系统可包括能够附接到保持矩阵(例如,保持矩阵6250)的材料层。现在参见图150,在至少一个实施例中,材料层6870可附接到保持矩阵6250的底部表面6251。在某些实施例中,层6870和/或保持矩阵6250可包括保持结构,所述保持结构能够将层6870保持到保持矩阵6250。在至少一个实施例中,可利用至少一种粘合剂将层6870粘附到保持矩阵6250。在任何情形中,层6870可包括底部表面或组织接触表面6873,底部表面或组织接触表面6873能够当保持矩阵6250朝钉6220向下运动以使保持孔6252与钉腿6221接合时,底部表面或组织接触表面6873接触组织T。在至少一个此类实施例中,层6870可由可压缩材料(例如可生物吸收的泡沫)构成,所述可压缩材料可被压缩于保持矩阵6250的底部表面6251与组织T之间。在各种实施例中,层6870还可包括存储和/或吸收于其中的至少一种药物,所述至少一种药物可在层6870被压缩时从层6870中释放。在至少一个实施例中,所述药物可包括至少一种组织密封剂、止血剂、和/或抗菌材料(例如离子银和/或三氯生)。在各种实施例中,层6870的压缩可从层6870中挤出药物,使得组织T的表面的全部或至少很大一部分涂覆有药物。此外,当层6870被压缩且钉腿6221穿透组织T及层6870时,药物例如可沿钉腿6221流下并治疗已被钉腿6221切开的组织。在各种实施例中,保持矩阵6250的主体可包括由生物相容性材料(例如钛和/或不锈钢)构成的第一层,并且底层6870可包括由可生物吸收材料(例如氧化再生纤维素(ORC)、如(液态的或被冷冻干燥的)纤维蛋白和/或凝血酶等生物活性剂、甘油、处于蓬松或泡沫构型的可吸收猪明胶、和/或例如离子银和/或三氯生等抗菌物)构成的第二层。另外的可生物吸收材料可包括例如Surgicel Nu-Knit、Surgicel Fibrillar、以商品名Promogran出售的胶原/ORC(其为与胶原矩阵形式构建物的混合物)、以商品名Vicryl出售的聚乙醇酸(PGA)、聚乳酸(PLA或PLLA)、聚对二氧环己酮(PDS)、聚羟基链烷酸酯(PHA)、以商品名Monocryl出售的聚卡普隆25(PGCL)、聚己内酯(PCL)、和/或PGA、PLA、PDS、PHA、PGCL、和/或PCL的复合物。尽管图150中仅示出一个层6870,然而可使用任何合适数目的层。在至少一个实施例中,包括第一药物的第一层可附接到保持矩阵6250,并且包括第二药物或不同药物的第二层可附接到第一层。在至少一个此类实施例中,可使用多个层,其中每个层可包括容纳在其中的不同药物和/或不同的药物组合。
现在参见图148,在各种实施例中,紧固件系统可包括附接到保持矩阵6250的底部表面6251的材料层6770。在某些实施例中,层6770和/或保持矩阵6250可包括保持结构,所述保持结构能够将层6770保持到保持矩阵6250。在至少一个实施例中,可利用至少一种粘合剂将层6770粘附到保持矩阵6250。在任何情形中,层6770可包括底部表面或组织接触表面6773,底部表面或组织接触表面6773能够当保持矩阵6250朝钉6220向下运动以使保持孔6252与钉腿6221接合时,底部表面或组织接触表面6773接触组织T。在至少一个此类实施例中,层6770可由可压缩材料(例如可生物吸收的泡沫)构成,所述可压缩材料可被压缩于保持矩阵6250的表面6251与组织T之间。在各种实施例中,层6770还可包括一个或多个囊或胞6774,所述一个或多个囊或胞6774能够在其中存储至少一种药物。参见图149,在某些实施例中,囊6774可与保持孔6252对齐或至少基本上对齐,使得当钉腿6221穿过组织T及层6770而被推动时,钉腿6221可刺穿囊6774和/或换句话讲使囊6774破裂。在囊6774破裂之后,存储在囊6774中的至少一种药物M可流出至组织T上。在至少一个此类实施例中,药物M可包括流体,所述流体可沿钉腿6221流下或通过钉腿引流并治疗刚被钉腿切开的组织T。由于上文所述,存储在囊6774中的药物可对组织提供局部治疗。在某些实施例中,薄片6770中的囊6774中可存储有不同的药物。例如,第一组囊6774中可存储有第一药物或第一药物组合,并且第二组囊中可存储有不同的药物或不同的药物组合。在各种实施例中,层6770可由柔性的硅氧烷薄片构成,并且囊6774可代表硅氧烷薄片中的空隙。在至少一个此类实施例中,硅氧烷薄片可包括能够相互附接的两个层,其中囊6774可被限定在所述两个层之间。在各种实施例中,层6770可包括一个或多个薄层或弱化部分(例如局部穿孔),所述一个或多个薄层或弱化部分可有利于腿6221切开层6770并使囊6774破裂。在某些实施例中,囊6774的至少一部分可被定位在穹窿6777中,其中穹窿6777可从薄片6770向上延伸。在至少一个此类实施例中,穹窿6777和/或囊6774的至少一部分可被定位在保持矩阵6250中所形成的凹坑6201内。在某些实施例中,囊6774可包括不彼此连接的独立的胞。在某些其他实施例中,囊6774中的一个或多个可经由延伸穿过层6770的一个或多个通路、导管、和/或通道而相互流体连通。公布于2010年8月24日且名称为“ADHESIVE AND MECHANICAL FASTENER”的美国专利7,780,685的公开内容据此全文以引用方式并入本文。
在各种实施例中,对上文进行进一步描述,其中包括仓体、钉、和/或对齐矩阵的钉仓可被加载至端部执行器的第一钳口中,并且相似地,保持矩阵和/或一个或多个盖可被加载至端部执行器的第二钳口中。现在参见图151,在某些实施例中,可使用器械(例如仓加载器6990)将两个或更多个紧固件仓同时插入端部执行器中。在至少一个实施例中,例如仓加载器6990可包括柄部6991及仓载体6992,其中仓载体6992可包括第一保持部和第二保持部,所述第一保持部能够将钉仓6200的仓体6210保持到仓载体6992,并且所述第二保持部能够保持仓体6980,该仓体6980在其中支撑多个保护帽6270并沿仓体6980的底部表面支撑保持矩阵6250。在各种实施例中,第一保持部和第二保持部可各自包括一个或多个保持构件,所述一个或多个保持构件能够可释放地接合仓体6210和6980。现在参见图152和图153,在使用中,端部执行器可包括第一钳口或底部钳口6230和第二钳口或顶部钳口6940,其中钉仓6200可被加载至第一钳口6230中,并且仓体6980可被加载至第二钳口6940中。在各种情况下,顶部钳口6940可通过致动器6235而从打开位置(图152)旋转到闭合位置(图153),其中致动器6235的操作如上所述,为简明起见此处不再赘述。现在参见图153,一旦顶部钳口6940处于其闭合位置,则仓载体6992的远端6993可被插入端部执行器中,使得钉仓6200穿过第一钳口6930的远端6938而滑动至第一钳口6230中的第一附接部或通道6939中。相似地,仓载体6992的远端6993可被插入端部执行器中,使得仓体6980穿过第二钳口6940的远端6948而滑动至第二钳口6940中的第二附接部或通道6949中。手持仓加载器6990的柄部6991的外科医生或其他临床医生可分别穿过通道6939和6949而推动钉仓6200及仓体6980,直至钉仓6200及仓体6980被完全安放于通道6939和6949中。
当钉仓6200和仓体6980被安放时,钉仓6200和仓体6980可分别接合其相应的钳口6230和6940中的一个或多个保持部,如下文所更详细地描述。现在参见图154,在任何情形中,一旦钉仓6200及仓体6980被安放,则仓加载器6990可与钉仓6200及仓体6980分离并从端部执行器上移除。在至少一个此类实施例中,用于将钉仓6200保持在第一钳口6230中的保持力可大于用于将钉仓6200保持到仓载体6992的保持力,使得当仓载体6992朝远侧被推出端部执行器时,钉仓6200可保持在第一钳口6230后方。相似地,用于将仓体6980保持在第二钳口6940中的保持力可大于用于将仓体6940保持到仓载体6992的保持力,使得当仓载体6992朝远侧被推出端部执行器时,仓体6940可保持在第二钳口6940后方。一旦仓加载器6990从端部执行器被移除,则所加载的第一钳口6230及所加载的第二钳口6940可相对于将被缝合的组织T进行定位。现在参见图155,第二钳口6940可从打开位置(图154)运动到击发位置(图155),以便使仓体6980所承载的保持矩阵6250及所述多个保护帽6270与位于钉仓6200中的钉6220接合。
现在参见图156及图157,第二钳口6940可被再次打开,并且所述多个保护帽6270及保持矩阵6250可与仓体6980分离,使得帽6270及保持矩阵6250可保持与组织T及钉仓6200接合。在至少一个实施例中,仓体6980可包括多个凹坑及一个或多个保持狭槽,所述多个帽6270能够可移除地定位在所述多个凹坑中,并且所述一个或多个保持狭槽能够将保持矩阵6250可移除地保持到仓体6980。在各种实施例中,在第二钳口6940打开之后,第二钳口6940的与仓体6980接合的保持构件可将仓体6980保持在第二钳口6940中。在某些实施例中,仓体6980能够当第二钳口6940打开时撕裂,使得仓体6980的一部分与帽6270及保持矩阵6250一起被植入,并且仓体6980的一部分保留在第二钳口6940中。相似地,再次参见图156和图157,在第二钳口6940打开之后,第一钳口6230的与仓体6210接合的保持构件可将仓体6210保持在第一钳口6230中。在某些实施例中,仓体6210能够当第一钳口6230远离已植入的仓6200被牵拉时撕裂,使得仓体6210的一部分与钉6220及对齐矩阵6260一起被植入,并且仓体6210的一部分保留于第一钳口6230中。现在参见图158-160,在各种实施例中,钉仓(例如钉仓6900)例如可包括沿仓体6910的长度延伸的一个或多个纵向保持狭槽6913,例如当钉仓6900被插入钳口6930中时,所述一个或多个纵向保持狭槽6913能够在其中容纳从钳口6930延伸的一个或多个纵向保持导轨6916。在使用中,在至少一个实施例中,例如在钉仓6900穿过保持通道6939的远端6938而滑动之前,保持狭槽6913的末端可与保持导轨6916的远端对齐。
再次参见图160,在各种实施例中,钳口6940可包括两个保持通道6949,其中每个保持通道6949能够在其中容纳包括多个帽6270及保持矩阵6250的仓体6980。在某些实施例中,每个仓体6980可包括一个或多个纵向保持肩部6917,所述一个或多个纵向保持肩部能够当仓体6980被插入钳口6940中的其相应的保持通道6949中时,所述一个或多个纵向保持肩部6917沿第二钳口6940的一个或多个纵向保持导轨6918滑动。在各种实施例中,当仓体6980与存储在其中的帽6270及保持矩阵6250上分离时,保持导轨6918及保持肩部6917可协作地将仓体6980保持在第二钳口6940中。现在参见图159,在各种实施例中,第二钳口6940还可包括从其延伸的一个或多个远侧凸块或保持构件6915,所述一个或多个远侧凸块或保持构件能够将仓体6980可移除地锁定在其相应的保持通道中。在至少一个此类实施例中,第二钳口6940可包括远侧凸块6915,远侧凸块6915相对于每个保持通道6949被配置及定位成使得当仓体6980被插入通道6949中时,每个仓体6980可围绕凸块6915挠曲,其中,就在仓体6915被完全安放于通道6949中时,仓体6980的远端可越过凸块6915并按扣于凸块6915上方。为在仓体6980被用过之后将其移除,如上所述,可将仓体6980拉回到凸块6915上方并将其从保持通道6949上移除。与上文相似,第一钳口6930可包括从其延伸的一个或多个远侧保持凸块6914,当钉仓6900被完全安放时,所述一个或多个远侧保持凸块能够容纳于仓体6910中的一个或多个保持沟槽或狭槽6912(图158)中。
在各种实施例中,对上文进行进一步描述,其中定位有多个第一紧固件的第一紧固件仓可被定位在外科紧固装置的第一钳口中,并且其中定位有多个第二紧固件的第二紧固件仓可被定位在外科紧固装置的第二钳口中。在使用中,第一钳口和/或第二钳口中的一者可朝另一者运动,以便使第一紧固件与第二紧固件接合并将组织固定在其间。在某些实施例中,当第一紧固件与第二紧固件接合时,第一紧固件仓可与第二紧固件仓接合。在至少一个实施例中,第一紧固件仓的主体可由第一可压缩材料构成,并且第二紧固件仓的主体可由第二可压缩材料构成,其中第一主体和/或第二主体可抵靠被紧固的组织而被压缩。在组织被紧固之后,第一钳口可远离已植入的第一紧固件仓运动,并且第二钳口可远离已植入的第二紧固件仓运动。随后,第一钳口可再次加载有另一个第一紧固件仓或类似元件,并且第二钳口可再次加载另一个第二紧固件仓或类似元件,并可再次使用外科紧固器械。尽管可在一些实施例中使用钉,然而也可设想出包括其他类型的紧固件(例如当相互接合时锁定在一起的分为两部分的紧固件)的其他实施例。在至少一个此类实施例中,第一紧固件仓可包括用于存储第一紧固件部分的第一存储部,并且第二紧固件仓可包括用于存储第二紧固件部分的第二存储部。在各种实施例中,本文所述的紧固系统可利用包括任何合适类型的材料和/或形式的紧固件。在某些实施例中,紧固件可包括穿透构件。此类穿透构件可例如由聚合物、复合物、和/或多层式基板构成。多层式基板的例子可为具有弹性体或聚合物涂层的线材或薄片基板。其可为薄的薄片,并且被形成为使得穿透构件被取向成垂直于或至少基本上垂直于连接构件。穿透构件可包括矩形的外形、半圆形的外形、和/或任何横梁外形。在各种实施例中,可利用任何合适的方法(例如线材挤出方法)来制造本文所述的紧固件。另一种可能性是使用精密加工方法来形成中空的穿透构件。这些穿透构件可由不同于线材挤出方法且使用材料组合的方法加工而成。
如上所述,钉腿的穿过保持矩阵突起的末端可由一个或多个帽和/或盖覆盖。在某些实施例中,钉腿的末端在插入穿过保持矩阵之后可变形。在至少一个实施例中,用于保持保持矩阵的钳口还可包括位于保持孔上方和/或与保持孔对齐的砧座凹坑,所述砧座凹坑能够在钉腿突起于保持矩阵上方时使钉腿变形。在各种实施例中,每个钉的钉腿可例如朝彼此和/或朝钉的中心向内卷曲。在某些其他实施例中,钉的钉腿中的一个或多个可远离其他钉腿和/或远离钉的中心而向外卷曲。在各种实施例中,不论钉腿沿哪一方向卷曲,钉腿的末端均可接触保持矩阵的主体并可不再次进入已被钉紧固的组织中。在至少一个实施例中,钉腿在穿过保持矩阵之后的变形可将保持矩阵锁定在定位中。
现在参见图161及图162,在各种实施例中,外科缝合器械(例如,外科缝合器7000)可包括第一钳口7030和第二钳口7040,其中第二钳口7040可通过致动器6235的运动而朝向和远离第一钳口7030运动。致动器6235的操作如上所述,为简明起见此处不再赘述。在各种实施例中,第一钳口7030可包括远端7031及近端7032,其中第一钳口7030可限定在远端7031与近端7032之间延伸的通道,所述通道能够容纳钉仓。为便于图示,图161中未绘示出此类钉仓的仓体,然而此类钉仓可包括仓体、位于仓体内的钉6220、以及位于钉6220下方的钉驱动器7012。在某些实施例中,尽管为简明起见未在图161中示出,然而第二钳口7040能够将保持矩阵(例如保持矩阵6250)保持在钉6220之上和/或如上所述移将保持矩阵运动至与钉6220的腿接合。在至少一个实施例中,外科缝合器7000还可包括例如位于第一钳口7030中的滑动件7010,滑动件7010可从第一钳口7030的远端7031朝近端7032滑动并朝第二钳口7040的保持矩阵提升钉驱动器7012及支撑在钉驱动器7012上的钉6220。在各种其他实施例中,例如滑动件7010可从近端7032朝远端7031运动,以便部署钉6020。在至少一个实施例中,滑动件7010可包括一个或多个倾斜的斜坡或凸轮7011,所述一个或多个倾斜的斜坡或凸轮能够在钉驱动器7012下方滑动并向上提升钉驱动器7012。在各种实施例中,外科缝合器7000还可包括例如可操作地联接到滑动件7010的拉杆或推杆,所述拉杆或推杆可通过位于外科缝合器7000的柄部和/或轴上的致动器而朝近侧和/或朝远侧运动。
再次参见图161,在各种实施例中,外科缝合器7000的第二钳口7040可包括框架7041、远端7048、及与远端7048相对定位的近端7049。在某些实施例中,第二钳口7040还可包括导向系统,所述导向系统包括沿框架7041的纵向轴线延伸的一个或多个导轨(例如导轨7045及7046),如下文所更详细地描述,所述一个或多个导轨能够引导能够在钉6220的钉腿6221穿过保持矩阵之后接合钉6220的钉腿并使其变形的一个或多个砧座或凸轮。在至少一个此类实施例中,导轨7045及7046可包括导向线或缆线,所述导向线或缆线例如沿框架7041的顶部或表面、围绕远侧柱7047、并返回沿框架7041的顶部或表面而延伸。如上所述,并且现在首先参见图163和图165,在各种实施例中,第二钳口7040还可包括一个或多个砧座或凸轮(例如第一砧座7050和第二砧座7060),所述一个或多个砧座或凸轮可沿第二钳口7040纵向地运动,以便在钉6220的腿穿过保持矩阵之后使所述腿变形。在至少一个实施例中,外科缝合器7000还可包括连接到和/或可操作地联接到第一砧座7050的第一砧座驱动器或致动器7051,该第一砧座驱动器或致动器能够朝近侧牵拉第一砧座7050和/或朝远侧推动第一砧座7050。相似地,在至少一个实施例中,外科缝合器7000还可包括连接到和/或可操作地联接到第二砧座7060的第二砧座驱动器或致动器,所述第二砧座驱动器或致动器能够朝远侧推动第二砧座7060和/或朝近侧牵拉第二砧座7060。在各种实施例中,第一砧座7050可包括导槽7052,并且第二砧座7060可包括导槽7062,该导槽7052和导槽7062可分别能够将导轨7045或导轨7046可滑动地容纳在其中。在至少一个此类实施例中,导轨7045及7046可被紧密地容纳在导槽7052及7062内,使得可防止或至少限制导轨7045及7046与导槽7052及7062之间发生相对的侧向运动或左右运动。
在某些实施例中,对上文进行进一步描述,可朝近侧拉动第一砧座7050并可朝远侧拉动第二砧座7060。参见图161,在至少一个实施例中,导轨7045及7046和远侧柱7047可包括滑轮系统,所述滑轮系统能够朝远侧牵拉第二砧座7060和/或朝近侧牵拉第二砧座7060。在至少一个此类实施例中,导轨7045及导轨7046可包括围绕远侧柱7047而延伸的连续线材或缆线,其中所述连续线材的一部分可被牵拉以使线材围绕远侧柱7047而轮转。在各种实施例中,导轨7046例如可被安装至第二砧座7060,使得当连续缆线沿第一方向轮转时,第二砧座7060可朝钳口7040的远端7048而被拉向远侧,并且当连续缆线沿第二方向或相反方向轮转时,第二砧座7060可朝近端7049而被拉向近侧。现在参见图163,在至少一个实施例中,导轨7046可被固定在导槽7062中,使得可在其间传递拉力。在至少一个此类实施例中,导轨7045能够在另一导槽7062中滑动。在各种实施例中,第一砧座7050能够以与第二砧座7060无关的方式工作,并且滑轮系统及限定在第一砧座7050中的导槽7052能够可滑动地容纳导轨7045及7046,使得容许滑轮系统及导槽7052与导轨7045及7046之间进行相对运动。在各种实施例中,构成导轨7045及7046的连续缆线可具有足够的柔性,以便适应顶部钳口7040的打开及闭合。连续缆线也可具有足够的柔性以便适应第二钳口7060朝向及远离底部钳口7030的垂直运动,下文将更详细地描述。
再次参见图163及图165,在各种实施例中,第一砧座7050可包括从其延伸的凸轮从动件7055,所述凸轮从动件7055能够骑跨于限定在第二钳口7040的框架7041中的一个或多个凸轮狭槽或导槽例如凸轮狭槽7070(图166)中。更具体地,在至少一个实施例中,框架7041可包括沿框架7041的第一侧纵向延伸的第一凸轮狭槽7070以及沿框架7041的第二侧或相对侧纵向延伸的第二凸轮7070,其中自第一砧座7050的第一侧延伸的凸轮从动件7055可骑跨于第一凸轮狭槽7070中,并且从第一砧座7050的第二侧延伸的凸轮从动件7055可骑跨于第二凸轮狭槽7070中。在至少一个此类实施例中,每个凸轮狭槽7070的轮廓可为相同的或至少基本上相同的,并可相互对齐或至少基本上对齐。相似地,在各种实施例中,第二砧座7060可包括从其延伸的凸轮从动件7065,所述凸轮从动件7065能够骑跨于限定在第二钳口7040的框架7041中的凸轮狭槽7070(图166)中。更具体地,在至少一个实施例中,从第二砧座7060的第一侧延伸的凸轮从动件7065可骑跨于第一凸轮狭槽7070中,并且从第二砧座7060的第二侧延伸的凸轮从动件7065可骑跨于第二凸轮狭槽7070中。在使用中,第一砧座7050的凸轮从动件7055和第二砧座7060的凸轮从动件7065可在凸轮狭槽7070内滑动,使得当第一砧座7050和第二砧座7060被拉向近侧和/或被推向远侧时,第一砧座7050和第二砧座7060沿凸轮狭槽7070的轮廓推进。在各种实施例中,每个凸轮狭槽7070可包括多个停歇部分或上部7071以及多个驱动器部或下部7072,所述多个停歇部分或上部7071以及所述多个驱动器部分或下部7072能够在砧座7050及7060沿纵向(即,在框架7041的远端7048与近端7049之间)运动的同时垂直地(即,朝向及远离底部钳口7030)运动砧座7050及7060,如下文所更详细地描述。
当外科缝合器7000处于未击发状态时,参见图166,第一砧座7050可定位在框架7041的远端7048,并且第二砧座7060可定位在框架7041的近端7049;此外,现在参见图167,当外科缝合器7000处于未击发状态时,定位在第一钳口7030的钉6220可能未插入组织T和/或定位于其上的保持矩阵。现在参见图168,在使用中,钉驱动器7012可在钉仓的钉腔7033内向上驱动钉6220;另外,第一砧座7050可从框架7041的远端7048朝远端7049向近侧运动,以便接合钉6220的钉腿6221。在至少一个实施例中,在第一砧座7050与钉6220的钉腿6221接合之前可向上驱动钉6220。在各种实施例中,在第一砧座7050推进至接触钉腿6221之前,滑动件7010可向上部署所有的钉6220,或作为另外一种选择,滑动件7010可在第一砧座7050朝近侧运动的同时朝近侧运动,然而滑动件7010可充分地引导第一砧座7050以将钉6220部署于第一砧座7050前方。在各种实施例中,如图168所示,凸轮狭槽7070能够或被布置成使得例如当第一凸轮7050穿过停歇部或上部时,第一凸轮7050的成形表面(例如成形表面或凸轮表面7053及7054)可接触钉腿6221中的至少一些。在各种情况下,第一砧座7050的凸轮从动件7055可分别被定位在凸轮狭槽7070的停歇部7071中,使得成形表面7053及7054处于抬高的位置,并使得当砧座7050由此穿过停歇位置中时,钉腿6221仅部分地变形。当第一凸轮7050沿凸轮狭槽7070进一步运动时,如图169所示,第一砧座7050的凸轮从动件7055可被驱动至凸轮狭槽7070的驱动部或下部7072中,使得成形表面7053及7054朝钉腿6021向下垂直运动,以便将钉腿6021驱动至其最终成形的构型中。随后,当第一砧座7050进一步沿凸轮狭槽7070推进时,第一砧座7050可被向上垂直驱动至凸轮狭槽7070的另一组停歇部7071中。如图168和图169所示,读者应注意,第一砧座7050可仅接合某些钉腿而不接合其他钉腿。在至少一个此类实施例中,第一砧座7050能够例如仅使包括钉6220的远侧钉腿6221的一组钉腿变形。在至少一个此类实施例中,第一砧座7050能够使远侧钉腿6221朝钉6220的中心变形。在各种实施例中,每个近侧钉腿6221均可两次被第一砧座7050(即,被第一成形表面7053及与第一成形表面7053对齐的第二成形表面7054)接触。在至少一个此类实施例中,当第一砧座7050处于停歇部或上部中时,第一成形表面7053可使远侧钉腿6221变形至部分变形构型,并且当第一砧座7050运动至驱动部或下部中时,第二成形表面7054可使远侧钉腿6221变形至完全成形构型。现在参见图163和图164,在各种实施例中,第一砧座7050可包括多个第一成形表面7053及多个第二成形表面7054,以便在钉腿6221被布置成不止一排或一行时使钉6220的远侧钉腿6221变形。在各种实施例中,如下文所更详细地描述,例如第二砧座7060可使钉6020的近侧钉腿6221变形。
在各种实施例中,对上文进行进一步描述,第一砧座7050可从框架7041的远端7048运动至近端7049,以便使钉6220的所有远侧钉腿6221变形。读者应注意,第一砧座7050可相对于未变形的近侧钉腿6221向上及向下运动,并且为适应此类相对运动,在各种实施例中,第一砧座7050可包括一个或多个间隙狭槽7057(图165),所述一个或多个间隙狭槽7057能够当第一砧座7050使远侧钉腿6221弯曲时容纳未弯曲的近侧钉腿6221。相似地,再次参见图163,第二砧座7060可包括间隙狭槽7067,该间隙狭槽能够当第一砧座7050如上所述在其停歇部与驱动部之间运动时适应上下运动的第一凸轮致动器7051的垂直运动。在所有远侧钉腿6221被弯曲之后,在至少一个实施例中,砧座致动器7061可使第二砧座7060从框架7041的近端7049运动至远端7048。与上文相似,现在参见图170,例如第二砧座7060的凸轮从动件7065可在凸轮狭槽7070内滑动,使得第二砧座7060在停歇部或上部与驱动部或下部之间运动,以便使近侧钉腿6221朝钉6220的中心向内变形。与上文相似,第二砧座7060可包括多个第一成形或凸轮表面7063以及多个第二成形或凸轮表面7064,所述多个第一成形或凸轮表面7063以及所述多个第二成形或凸轮表面7064可分别能够使近侧钉腿6021中的一个或多个至少部分地变形和/或完全变形。再次参见图164,第二砧座7060可包括多个第一成形表面7063及多个第二成形表面7064,所述多个第一成形表面7063及所述多个第二成形表面7064能够使排列成多个排或多个行的钉6220的近侧钉腿6221变形。同样如图164所示,第二砧座7060的第一成形表面7063和第二成形表面7064可不与第一砧座7050的第一成形表面7053和第二成形表面7054对齐,因此钉6220的近侧腿6221可与钉6220的远侧腿6221位于不同的排或行中。读者还应注意,当第二砧座7060朝远侧运动时,第二砧座7060可推动第一砧座7050。在至少一个此类实施例中,第二砧座7060可将第一砧座7050推回至框架7041的远端7048中,使得第一砧座7050可返回至其初始位置或未击发位置。在钉6220的所有近侧钉腿6221均变形之后,第二砧座7060可朝近侧缩回并返回至其初始位置或未击发位置。如此一来,外科缝合器7000可复位成使得可在第一钳口7030中定位新的钉仓,并可在第二钳口7040中定位新的保持矩阵,以便再次使用外科缝合器7000。
在各种实施例中,如上所述,外科缝合器可包括两个或更多个砧座,所述两个或更多个砧座可纵向地行进以便沿横向接合多个钉的腿。在某些实施例中,外科缝合器可包括朝近侧运动的砧座,例如以使第一组钉腿变形并例如使第二组钉腿变形。在至少一个此类实施例中,此类砧座可包括例如面向近侧的成形表面及面向远侧的成形表面。
现在参见图171,在各种实施例中,砧座诸如砧座7140可包括底部表面或组织接触表面7141以及限定在底部表面或组织接触表面7141中的多个成形凹坑7142。在至少一个实施例中,砧座7140可包括能够焊接到框架7144中的不止一个板,例如凹坑板7143。在至少一个此类实施例中,每个凹坑板7143均可被定位在框架7144中的板通道7145中并通过延伸穿过框架7144的焊接狭槽7146而被焊接到框架7144以便形成纵向焊接件7147。在各种实施例中,纵向焊接件7147例如可包括沿焊接狭槽7146的整个长度延伸的连续焊接件或沿焊接狭槽7146的长度延伸的一系列在空间上间隔开的焊接点。在各种实施例中,每个凹坑板7143均可包括已被焊接到一起的两个或更多个板部分。在至少一个此类实施例中,每个凹坑板7143均可包括能够沿接缝7148焊接到一起的第一板部分7143a和第二板部分7143b。在各种实施例中,在板7143被焊接到框架7144中的板通道7145中之前,每个板7143的第一板部分7143a和第二板部分7143b可被焊接到一起。在至少一个此类实施例中,第一板部分7143a和第二板部分7143b可包括能够配合到一起以形成紧密接缝7148的协作外形,例如图171中所示的齿状外形。在至少一个实施例中,每个板7143可包括例如大约.02"的高度,所述高度可高于板通道7145的深度,使得板7143的组织接触表面7141从砧座7040的框架7044延伸。现在参见图172,在某些实施例中,板7143可例如通过位于板7143的远端处的至少一个焊接件7149而连接到一起。
如图171和图172所示,每个凹坑板7143均可包括被限定在其中的多个成形凹坑7142。在各种实施例中,可通过任何合适的制造方法(例如研磨方法和/或电极燃烧方法)在板7143中形成成形凹坑7142。现在参见图173和图174,在至少一个此类实施例中,例如可通过以下方法来制造每个成形凹坑7142:首先形成深井7150,随后围绕深井7150形成弓形的或弯曲的表面7151,然后在弯曲的表面7151中形成钉腿引导沟槽7152。在各种其他实施例中,可以任何合适的顺序来执行这些步骤。现在参见图175,在各种实施例中,钉成形凹坑7142可被形成为使成形凹坑的内缘7153被一致的或至少基本上一致的间隙7154间隔开。在至少一个此类实施例中,间隙7154可例如为大约.008"。此外,在至少一个此类实施例中,成形凹坑7142可沿两个或更多个行或线定位,成形凹坑7142的中心线可被一致的或至少基本上一致的间距7155间隔开。在至少一个此类实施例中,中心线之间的间距7155可例如为大约.035"。再次参见图175,在各种实施例中,每个成形凹坑7142可在窄的宽度7156与宽的宽度7157之间逐渐变细。在至少一个此类实施例中,例如窄的宽度7156可为大约.045",并且宽的宽度7157可为大约.075"。在各种实施例中,板7143可由与框架7144相同的材料构成。在至少一个此类实施例中,板7143及框架7144两者均可例如由不锈钢(例如300系列或400系列的不锈钢)和/或钛构成。在各种其他实施例中,板7143及框架7144可由不同的材料构成。在至少一个此类实施例中,板7143可例如由陶瓷材料构成,并且框架7144可例如由不锈钢和/或钛构成。在各种情况下,根据所使用的材料,例如除上述焊接方法之外或作为上述焊接方法的替代,还可使用至少一种硬钎焊方法将板7143固定在框架7144中。
现在参见图176-178,在各种实施例中,砧座7240可包括框架7244以及可被插入框架7244中的多个凹坑板7243。与上文相似,每个凹坑板7243可包括限定在其中的多个成形凹坑7242。在至少一个实施例中,砧座框架7244可包括限定在其中的保持狭槽7246,该保持狭槽能够容纳从凹坑板7243延伸的保持导轨7247。为将凹坑板7243组装到砧座框架7244,该砧座框架7244的侧壁7245可向外挠曲或展开(如图177所示),以使保持狭槽7246变宽,从而使每个保持狭槽7246可在其中容纳凹坑板7243的保持导轨7247。一旦保持导轨7247被定位在保持狭槽7246中,侧壁7245即可被释放(如图178所示),从而容许框架7244以弹性方式缩回和/或返回至其未挠曲状态。在这种情形中,保持狭槽7246可缩回并因此将保持导轨7247捕获在其中。在某些实施例中,保持导轨7247和/或保持狭槽7246可包括一个或多个协作的锥形表面;在挠曲的保持狭槽7246被释放之后,所述一个或多个配合的锥形表面可形成能够将保持导轨7247保持在保持狭槽7246中的锥形锁接合。与上文相似,凹坑板7243可由与框架7244相同或不同的材料构成。在至少一个此类实施例中,板7243可例如由陶瓷材料构成,并且框架7244可例如由不锈钢和/或钛构成。在各种情况下,根据所使用的材料,例如可使用至少一种硬钎焊方法和/或至少一种焊接方法将板7243固定在框架7244中。
在图179和180中,外科缝合和切断器械8010可包括砧座8014,该砧座可围绕其到细长钉槽8016的枢转附接而被反复打开和闭合。钉施用组件8012可包括砧座8014和槽8016,其中组件8012可朝近侧附接到形成工具部分8022的细长轴8018。当钉施用组件8012闭合时,或至少基本上闭合时,工具部分8022可呈现足够小的横截面,该横截面适于使钉施用组件8012通过套管针插入。在各种实施例中,组件8012可由连接至轴8018的柄部8020操纵。柄部8020可包括用户控件诸如旋转旋钮8030,该旋转旋钮使细长轴8018和钉施用组件8012围绕轴8018的纵向轴线旋转。闭合触发器8026可被压下以闭合钉施用组件8012,该闭合触发器可在手枪式握把8036前围绕横跨柄部外壳8154侧向接合的闭合触发器销8152(图181)枢转。在各种实施例中,当闭合触发器8026被夹紧时,闭合释放按钮8038可向外存在于柄部8020上,使得释放按钮8038可被压下以松开闭合触发器8026并打开钉施用组件8012,如下文更详细所述。可在闭合触发器8026前枢转的击发触发器8034可使钉施用组件8012同时切断和缝合被夹持在其中的组织。在各种情况下,如下文更详细所述,可使用击发触发器8034采用多个击发冲程以减少每冲程需要由外科医生的手所施加的力的大小。在某些实施例中,柄部8020可包括可指示击发进度的可旋转的右指示器轮8040和/或左指示器轮8041(图181)。例如,完全击发行程可能需要击发触发器8034的三个完全击发冲程,因而指示器轮8040,8041各自可在击发触发器8034的每冲程旋转至多三分之一转。如下文更详细所述,如果需要,手动击发释放杠杆8042可允许击发系统在完全击发行程完成之前回缩,并且此外,如果击发系统卡住和/或失效,击发释放杠杆8042可允许外科医生或其他临床医生使击发系统回缩。
结合图179和图181,细长轴8018可包括外部结构,该外部结构包括在纵向上往复运动的闭合管8024,该闭合管响应于柄部8020的闭合触发器8026的近侧下压而使砧座8014朝向其闭合位置枢转。细长槽8018可通过闭合管8024内部的框架8028(图181)连接至柄部8020。框架8028可旋转地接合至柄部8020,使得旋转旋钮8030(图179)的旋转可使工具部分8022旋转。具体参见图181,旋转旋钮8030可由两个半壳构成,该两个半壳可包括一个或多个向内突出部8031,该突出部可延伸穿过闭合管8024中的一个或多个细长的侧开口8070并接合框架8028。因此,旋转旋钮8030和框架8028可一起或同时被旋转,使得旋钮8030的旋转位置决定工具部分8022的旋转位置。在各种实施例中,较长开口8070的纵向长度足够长,以允许闭合管8024的纵向闭合运动和打开运动。关于产生闭合管8024的闭合运动,首先参见图181和图183,闭合触发器8026的上部8160可通过闭合连杆8164向前推动闭合轭8162。闭合连杆8164在其远端处通过闭合轭销8166以能够枢转的方式附接至闭合轭8162,并且在其近端处通过闭合连杆销8168以能够枢转的方式附接。在各种实施例中,闭合触发器8026可被闭合触发器拉伸弹簧8246推进至打开位置,该拉伸弹簧朝近侧连接至闭合触发器8026的上部8160以及由右半壳8156和左半壳8158形成的柄部外壳8154。由拉伸弹簧8246施加的张力可被施加至闭合触发器8026的闭合力克服,以便朝远侧推进轭8162、闭合连杆8164以及闭合管8024。
如上所述,当闭合触发器8026被致动或压下时,如果需要,闭合释放按钮8038可被定位成使得外科医生或其他临床医生能够按下闭合释放按钮8038,并且使闭合触发器8026以及外科器械的其余部分返回至未致动状态。在各种实施例中,闭合释放按钮8038可通过中央侧向枢轴8173连接至枢转锁定臂8172,使得可在释放按钮8038和锁定臂8172之间传递运动。再次参见图181,压缩弹簧8174可将闭合释放按钮8038朝近侧偏置,即,如从右面观察,围绕中央侧向枢轴8173顺时针偏置,并且闭合触发器8026的上部8160可包括具有后凹口8171的近侧齿顶8170。当闭合触发器8026被压下时,枢转锁定臂8172可骑跨在近侧齿顶8170上,并且当闭合触发器8026到达其完全压下位置时,应当理解,后凹口8171存在于枢转锁定臂8172下面,该枢转锁定臂在压缩弹簧8174的迫使下落入并锁紧后凹口8171。此时,闭合释放按钮8038的手动下压使枢转锁定臂8172向上并从后凹口8171中旋转出,从而将闭合触发器8026解锁并使闭合触发器8026返回至其未夹紧位置。
一旦闭合触发器8026朝近侧被夹紧,如上所述,则击发触发器8034可被拉向手枪式握把8036,以便从柄部8020朝远侧推进击发连杆8032。在各种实施例中,击发触发器8034可围绕击发触发器销8202枢转,该击发触发器销横向穿过柄部8020的右半壳8156和左半壳8158并与其接合。当被致动时,击发触发器8034可推进连杆式传动击发机构8150。连杆式传动击发机构8150可被弹簧8184迫使至回缩的、未击发位置。该弹簧:1)附接至柄部8020的手枪式握把8036;以及2)附接至例如连杆式传动击发机构8150的其中一个连杆,如下文更详细所述。弹簧8184可包括连接至外壳8154的非运动端部8186和连接至钢带8192的近端8190的运动端部8188。钢带8192的设置于远侧的端部8194可附接至多个连杆8196a-8196d中的前连杆8196a上的附接结构8195,所述多个连杆形成连杆式齿条8200。连杆式齿条8200可为柔性的,使得其可容易地回缩进手枪式握把8036并最小化柄部8020的长度,然而形成直的刚性的齿条组件,该齿条组件可将显著的击发力传递至和/或穿过击发连杆8032。如下文更详细所述,击发触发器8034可在击发触发器8034的第一致动期间与第一连杆8196a接合,在击发触发器8034的第二致动期间与第二连杆8196b接合,在击发触发器8034的第三致动期间与第三连杆8196c接合,并且在击发触发器8034的第四致动期间与第四连杆8196d接合,其中击发触发器8034的每次致动可将连杆式齿条8200朝远侧推进递增的量。在各种实施例中,对上文进行进一步描述,击发触发器1034的多个冲程可使右指示器轮1040和左指示器轮1041旋转,以指示连杆式齿条8200已推进的距离。
现在参见图181和图183,防倒退机构8250可防止组合拉伸/压缩弹簧8184使连杆式齿条8200在击发冲程之间回缩。在各种实施例中,联接滑动管8131邻接第一连杆8196a并连接至击发连杆8032以传递击发运动。击发连杆8032朝近侧延伸出框架8028的近端并延伸穿过防倒退板8266的通孔8408。通孔8408的尺寸设定成当与击发连杆8032垂直对齐时滑动地容纳击发连杆8032,而当倾斜时使击发连杆在通孔中轧紧不动。下部插片附接件8271从框架8028的近端的下唇缘朝近侧延伸,延伸穿过防倒退板8266的下边缘上的孔8269。该下部插片附接件8271将防倒退板8266的下部拉动到邻近框架8028,使得当击发连杆8032朝远侧被推进时防倒退板8266为垂直的,并且当击发连杆8032试图回缩时防倒退板8266能够使顶部向后倾斜至束缚状态。防倒退压缩弹簧8264被框架8028的近端朝远侧约束,并且朝近侧邻接防倒退板8266的顶部,从而将防倒退板8266偏置到锁定状态。防倒退凸轮管8268抵抗弹簧偏置而滑动地环绕联接滑动管8131并且邻接防倒退板8266。附接至防倒退凸轮管8268的朝近侧突出的防倒退轭8256延伸超出闭合轭8162。
参见图181,连杆触发的自动回缩机构8289结合到外科缝合和切断器械8010中,以使刀在完全击发行程结束时回缩。为此,远侧连杆8196d包括柄脚8290,当远侧连杆8196d被推进至形成于闭合轭8162中的齿条槽8291(图181)中时柄脚向上突起。对齐该柄脚8290以启动防倒退释放杠杆8248(图186)上的底部近侧凸轮8292。具体参见图186和图187,形成于右半壳8156和左半壳8158中的结构约束防倒退释放杠杆8248的运动。分别形成于右半壳8156和左半壳8158之间的销插座8296和圆形销8293穿过纵向细长的孔8294被容纳,该孔形成于底部近侧凸轮8292远侧的防倒退释放杠杆8248中,从而允许纵向平移以及围绕圆形销8293旋转。在右半壳8156中,朝近侧打开的槽8295包括与向上地且朝远侧成角度的部分8295b连通的近侧水平部分8295a,该向上地且朝远侧成角度的部分8295b容纳防倒退释放杠杆8248的近端附近的向右的后销8297(图187),从而当防倒退释放杠杆8248到达其平移的最远侧部分时,该向上地且朝远侧成角度的部分8295b赋予向上的旋转。一旦防倒退释放杠杆8248被组装,形成于邻近防倒退释放杠杆8248的右半壳8156中的阻挡结构防止防倒退释放杠杆8248朝近侧运动,以使向右的后销8297保持在朝近侧打开的槽8295中。
对上文进行进一步描述,如图187和图188所示,防倒退释放杠杆8248的远端8254因而朝远侧及向下被驱使,使向右的前销8298落入形成于右半壳8156中的朝远侧打开的阶梯结构8299中,该接合通过将压缩弹簧8300(图188)固定至位于向右的前销8298和纵向细长的孔8294之间的防倒退释放杠杆8248上的向左的钩8301而实现。压缩弹簧8300的另一端附接至形成于右半壳8156中在闭合轭8266的紧上方更近且更低的位置处的钩8302(图186、图188、图189)。压缩弹簧8300因而将防倒退释放杠杆8248的远端8254向下和向后牵拉,使向右的前销8298在朝远侧被推进时锁定到朝远侧打开的阶梯结构8299中。因此,一旦被松开,参见图189,防倒退释放杠杆8248保持向前,垂直地保持防倒退板8266,从而使连杆式齿条8200回缩。当在松开端部执行器8012的情况下闭合轭8266随后回缩时,闭合轭8266上的向上突起的复位柄脚8303接触防倒退释放杠杆8248的底部远侧凸轮8305,将向右的前销8298从朝远侧打开的阶梯结构8299中抬起,使得防倒退压缩弹簧8264可将防倒退凸轮管8268和防倒退释放杠杆8248朝近侧推动至其回缩位置(图186)。
在各种实施例中,参见图179和图189,击发触发器8034能够以任何合适的方式可操作地接合至连杆式齿条8200。具体参见图180和图185,击发触发器8034围绕连接至外壳8154的击发触发器销8202枢转。当击发触发器8034朝手枪式握把8036压下时,击发触发器8034的上部8204围绕击发触发器销8202朝远侧运动,从而将朝近侧放置的击发触发器拉伸弹簧8206(图181)拉伸,该拉伸弹簧朝近侧连接在击发触发器8034的上部8204和外壳8154之间。在每次击发触发器下压期间,击发触发器8034的上部8204经由弹簧偏置的侧制转杆机构8210接合连杆式齿条8200。当击发触发器被释放时,侧制转杆机构与连杆式齿条8200分离,并且击发触发器可返回至未压下或未击发位置。在使用中,由连杆8196a-8196d的每个中面向近侧和向右的斜面8284所形成的倾斜的右侧轨道由侧制转杆组件8285接合。具体地,制转杆滑块8270(图181和图183)具有左下部导轨和右下部导轨8272,该左下部导轨和右下部导轨分别在形成于齿条槽8291下方的闭合轭8266中的左轨道8274(图181)中并且在闭合轭导轨8276中的右轨道8275中滑动。闭合轭导轨8276平行于齿条槽8291并附接至齿条槽盖8277,该齿条槽盖关闭闭合轭8266中的齿条槽8291的向右打开部分,所述向右打开部分位于制转杆滑块8270的行进的远侧。在图181、图182和图185中,压缩弹簧8278被附接在闭合轭导轨8276上的顶部近侧位置上的钩8279以及制转杆滑块8270的远端右侧上的钩8280之间,这使得制转杆滑块8270朝近侧向下与击发触发器8034的上部8204接触。
具体参见图181,制转杆块8318位于制转杆滑块8270上,围绕垂直的后销8320枢转,该后销穿过制转杆块8318和制转杆滑块8270的左侧近侧拐角。踢出块凹槽8322形成于块8318的顶部表面的远侧部分上,以容纳由垂直销8326以能够枢转的方式固定于其中的踢出块8324,该垂直销的底部末端延伸到制转杆滑块8270的顶部表面上的制转杆弹簧凹槽8328中。制转杆弹簧凹槽8328中的制转杆弹簧8330延伸到垂直的前销8326的右侧,迫使制转杆块8318在从上方观察时逆时针旋转至与倾斜的右侧轨道8282接合。踢出块凹槽8322中的小的卷簧8332迫使踢出块8324在从上方观察时顺时针旋转,使其近端被迫与形成于齿条槽8291上方的闭合轭8266中的波状唇缘8334接触。如图184所示,制转杆弹簧8330相较于小的卷簧8332而言所具有的更强的机械优势意味着制转杆块8318易于与顺时针旋转的踢出块8324接合。在图185中,当击发触发器8034被完全压下并开始被释放时,踢出块8324在制转杆滑块8270回缩时遇到波状唇缘8334的脊8336,迫使踢出块8324在从上方观察时顺时针旋转,从而将制转杆块8318踢出与连杆式齿条8200的接合。踢出块凹槽8322的形状使踢出块8324的顺时针旋转停止,使其处于垂直于波状唇缘8334的方向,在完全回缩期间保持该脱离从而消除棘轮噪音。
在图181、图183、图190和图195中,外科缝合和切断器械8010可包括手动回缩机构8500,该手动回缩机构提供击发机构的手动释放、手动回缩,并且在一种型式(图196-202)中在完全击发行程结束时还执行自动回缩。现在参见图181、图190和图191,具体地,前空转齿轮8220与连杆式齿条8200的齿状左上表面8222接合,其中前空转齿轮8220还接合具有较小右侧棘轮齿轮8231的后空转齿轮8230。前空转齿轮8220和后空转齿轮8230可旋转地连接至分别位于前空转轮轴8232和后空转轮轴8234上的柄部外壳8154。后空转轮轴8232的每端延伸穿过相应的右半壳8156和左半壳8158,并且附接至左指示器轮8040和右指示器轮8041,并且由于后轮轴8234在柄部外壳8154中自由旋转并以键合方式接合至后齿轮8230,因此指示器轮8040,8041和后齿轮8230一起旋转。可有利地选择连杆式齿条8200、空转齿轮8220和后齿轮8230之间的齿轮关系,使得齿状上表面8222具有强度适当的齿尺寸,并且使得在连杆式传动击发机构8150的完全击发行程期间,后齿轮8230的转动不超过一圈。齿轮机构8502除了直观地指示击发行程或进度之外,齿轮机构8502还可用于使刀手动回缩。在各种实施例中,后空转齿轮8230的较小的右侧棘轮齿轮8231延伸到手动回缩杠杆8042的轮毂8506中,具体地与将轮毂8506对分的垂直的纵向对齐狭槽8508(图190)对齐。轮毂8506的侧向通孔8510和上部凹槽8512连通。前部8514被成形为容纳朝近侧引导的锁定制转杆8516,该锁定制转杆围绕形成于上部凹槽8512的远端中的向右的侧向销8518枢转。后部8520被成形为容纳L型弹簧插片8522,该弹簧插片迫使锁定制转杆8516向下与右侧较小的棘轮齿轮8231接合。阻挡结构8524(图186和图193)从右半壳8156突起到上部凹槽8512中;当手动回缩杠杆8042向下时(图193),该阻挡结构阻止锁定制转杆8516接合较小的右侧棘轮齿轮8231。卷簧8525(图181)迫使手动回缩杠杆8042向下。
在使用中,如图192和图193所示,组合拉伸/压缩弹簧8184可与定位在远侧的连杆式齿条脱离。在图194和图195中,当手动回缩杠杆8042抬起时,锁定制转杆8516顺时针旋转并不再被阻挡结构8524阻止,并接合较小的右侧棘轮齿轮8231,从而使后空转齿轮8230在从左侧观察时顺时针旋转。因此,前空转齿轮8220逆时针响应,使连杆式齿条8200回缩。此外,向右的弯曲脊8510从轮毂8506突出,并且其尺寸设定成接触并朝远侧运动防倒退释放杠杆8248,以当手动回缩杠杆8042旋转时,该防倒退释放杠杆释放防倒退机构8250。
在图196-202中,外科缝合和切断器械8010a的自动回缩机构8600可在完全击发行程结束时将自动回缩结合到具有齿8602的前空转齿轮8220a中;该前空转齿轮在凸轮8606中的圆形沟槽8604内运动,直到在对应于三个击发冲程的将近全程旋转之后遇到阻碍物8608。在此类情况下,向右的脊8610向上旋转到接触底部凸轮凹槽8612,以朝远侧运动防倒退释放杠杆8248a。具体参见图197,防倒退释放杠杆8248a包括如在前所述操作的远端8254。分别形成于右半壳8156和左半壳8158之间的圆形销8293和销插座8296穿过形成于底部凸轮8192后面的防倒退释放杠杆8248a中的大致矩形的孔8294a被容纳,从而允许纵向平移以及防倒退释放杠杆8248a的远端8254的向下锁定运动。在右半壳8156中,水平的朝近侧打开的槽8295a容纳防倒退释放杠杆8248a的近端附近的向右的后销8297。
在操作中,在图198,198A中的击发之前,连杆式齿条8200和防倒退凸轮管8268处于回缩位置,从而当防倒退压缩弹簧8264使防倒退板8266朝近侧倾斜时,防倒退机构8250被锁定。自动回缩机构8600处于初始状态,其中防倒退释放杠杆8248a回缩,连杆8196a与前空转齿轮8220a接触。齿8602处于六点整的位置,其中圆形沟槽8604的全行程逆时针进行,向右的脊8610刚好邻近齿8602。在图199、图199A中,已发生一个击发冲程,将一个远侧连杆8196b向上运动到与前空转齿轮8220a接触。齿8602已通过固定凸轮8606的圆形沟槽8604前进了三分之一转。在图200、图200A中,已发生第二个击发冲程,将又一个连杆8196c向上运动到与前空转齿轮8220a接触。齿8602已通过固定凸轮8606的圆形沟槽8604前进了三分之二转。在图201、图201A中,已发生第三个击发冲程,将一个远侧连杆8196d向上运动到与前空转齿轮8220a接触。齿8602已围绕圆形沟槽8604全程前进到与阻碍物8608接触,从而启动凸轮8606的逆时针旋转(当从右侧观察时),从而使向右的脊8608与防倒退释放杠杆8248a接触。在图202中,防倒退释放杠杆8248a作为响应已朝远侧运动,从而将向右的前销8298锁定到朝远侧打开的阶梯结构8299中并且释放防倒退机构8250。相似的外科缝合器械公开于2006年8月1日公布的美国专利7,083,075中,该专利的全部公开内容以引用方式并入本文。
参见图203,外科缝合器械9010的钉施用组件9012实现如下功能:在组织上夹紧、通过沿轴9016相对于轴架9070纵向向下传递的两种不同运动来驱动钉以及切断组织。轴架9070朝近侧附接至外科缝合器械的柄部并联接至其,以围绕纵向轴线旋转。用于外科缝合和切断器械的例证性多冲程柄部在共同未决以及共同拥有的名称为“SURGICAL STAPLINGINSTRUMENT INCORPORATING A MULTISTROKE FIRING POSITIONINDICATOR AND RETRACTION MECHANISM”的美国专利申请序列号10/374,026中进行了更详细的描述,该专利申请的公开内容全文以引用方式并入。符合本发明的其他应用可结合单击发冲程,例如在共同未决以及共同拥有的名称为“SURGICAL STAPLING INSTRUMENT HAVINGSEPARATE DISTINCT CLOSING AND FIRING SYSTEMS”美国专利申请序列号10/441,632中所描述的那样,该专利申请的公开内容全文以引用方式并入。
具体参见图204,轴架9070的远端附接至钉槽9018。砧座9022具有近侧枢转端9072,该近侧枢转端以能够枢转的方式容纳在钉槽9018的近端9074内,正好位于其与轴架9070附接处的远侧。当砧座9022向下枢转时,砧座9022使组织接触表面9028和成形凹坑9026朝相对的钉仓运动,如下文进一步更详细所述。砧座9022的枢转端9072包括闭合结构9076,该闭合结构邻近其与钉槽9018的附接处但是在其与钉槽附接处的远侧。因此,闭合管9078(其远端包括接合该闭合结构9076的马蹄形孔9080)选择性地在近侧纵向运动期间将打开运动赋予砧座9022,并且在闭合管9078的远侧纵向运动期间将闭合运动赋予砧座9022,该闭合管9078响应于闭合触发器在轴架9070之上滑动,类似于上文所述。轴架9070促使并引导击发运动从柄部穿过纵向往复运动的拼合式刀和击发杆9090。具体地,轴架9070包括纵向击发杆狭槽9092,该纵向击发杆狭槽容纳拼合式刀和击发杆9090的近侧部分,具体地为层合渐缩的击发杆9094。应当理解,层合渐缩的击发杆9094可由实心的击发杆和/或任何其他合适的材料代替。
E型横梁9102为拼合式刀和击发杆9090的远侧部分,其有利于单独闭合和击发,以及在击发期间将砧座9022和细长钉槽9018间隔开。具体参见图204和图205,除了任何附接处理例如硬钎焊和粘合剂外,刀和击发杆9090还由形成于E型横梁9102中的凹形垂直附接孔9104形成,该孔容纳由层合渐缩的击发杆9094在远侧呈现的相应的凸形附接构件9106,从而使每个部分由适于其不同功能(例如强度、柔韧性、摩擦力)的选定的材料和方法形成。E型横梁9102可有利地由具有合适材料特性的材料形成,以形成一对顶部销9110、一对中间销9112以及底部销或支脚9114,以及能够获得锋利刀刃9116。此外,托住刀刃9116的每个垂直端的一体成型且朝近侧突出的顶部导向装置9118和中间导向装置9120还限定了组织集结区域9122,有助于在切断组织前将组织引导至锋利刀刃9116。中间导向装置9120还用于通过邻接楔形滑动件9126(图206)的阶梯式中央构件9124来接合并击发钉施用设备9012,从而通过钉施用组件9012实现钉的形成,如下文更详细所述。相比于由多个部件来进行组装而言,与E型横梁9102整体地形成这些结构(例如,顶部销9110、中间销9112和底部支脚9114)有利于在相对于彼此更紧密度的容限下进行制造,从而确保了在击发和/或与钉施用组件9012的各种锁定结构的有效相互作用期间进行期望的操作。
在图207和图208中,钉施用组件9012被示为打开的,其中E型横梁9102完全回缩。在组装期间,E型横梁9102的下部支脚9114穿过扩大孔9130落入钉槽9018中,并且E型横梁9102随后被推进,使得E型横梁9102沿着形成于钉槽9018中的下轨道9132朝远侧滑动。具体地,下轨道9132包括狭槽9133,其在钉槽9018的下表面上打开作为扩大狭槽9134,以在侧向横截面中形成反转的T型,如在图208和图209中具体所示;该狭槽9133与扩大孔9130连通。一旦被组装,在近侧联接至层合渐缩的击发杆9094的部件不允许下部支脚9114再次朝近侧行进至扩大孔9130以允许脱离。参见图210,层合渐缩的击发杆9094有利于将钉施用组件9012穿过套管针插入。具体地,当E型横梁9102完全回缩时,更远侧的向下的突出部9136抬起E型横梁9102。这通过向下的突出部9136在某一点发生位移来实现;在该点处,该突出部在钉槽9018中的扩大孔9130的近侧边缘上向上凸轮。现在参见图211,层合渐缩的击发杆9094还增强某些锁定结构的操作,所述锁定结构可通过包括更近侧的向上的突出部9138而结合到钉槽9018中;所述突出部在击发行程的初始部分期间由轴架9070向下驱使。具体地,侧向杆9140被限定在轴架9070(图204)中的一对方形孔9142之间。向下包围侧向杆9140的夹子弹簧9144迫使层合渐缩的击发杆9094的一部分从纵向击发杆狭槽9092中朝远侧突出,确保适当的时候某些有利的锁定结构被接合。当向上的突出部9138接触夹子弹簧9144时,该推动力更为明显或仅局限于击发行程的那部分。
在图207和图208中,E型横梁9102回缩,其顶部销9110位于砧座9022的枢转近端附近的砧座凹坑9150内。向下打开的垂直砧座狭槽9152(图203)将砧座9022侧向扩大成砧座内部轨道9154,当E型横梁9102的顶部销9110在击发期间朝远侧推进时,砧座内部轨道捕获E型横梁9102的顶部销9110,如图210和图211所示,将砧座9022与钉槽9018断然间隔开。因此,当E型横梁9102回缩后,外科医生能够反复打开和闭合钉施用组件9012,直到对捕获于其中待缝合和切断的组织的放置和取向感到满意,而且E型横梁9102甚至对于具有减少的直径和相应地减少刚度的钉施用组件9012而言也有助于组织的恰当定位。在图203、图204、图206、图207、图209和图215中,钉施用组件9012示出为具有包括楔形滑动件9126的可替换钉仓9020。纵向对齐且平行的多个向下打开的楔形狭槽9202(图209)容纳楔形滑动件9126必需的相应的楔形物9204。在图209-211中,楔形滑动件9126因此向上凸轮多个钉驱动器9206,所述多个钉驱动器在钉驱动器凹槽9208内可垂直滑动。在该例证性型式中,每个钉驱动器9206包括两个垂直插针,每个垂直插针向上平移到相应的钉孔9210或腔体9024中,以将靠在砧座9022的钉成形表面9214(图211)上的钉9023向上挤出并使其变形。限定在邻近钉槽9018的钉仓9020内的中央击发凹槽9216(图204)允许楔形滑动件9126的底部水平部分9218(图206)以及E型横梁9102的中间销9112通过。具体地,钉仓托盘9220(图204、图209)附接至聚合物钉仓体9222并位于其下面;该聚合物钉仓体具有形成于其中的钉驱动器凹槽9208、钉孔9210和中央击发凹槽9216。当钉9023因此在任一侧成形时,锋利刀刃9116进入垂直通槽9230,除了该垂直通槽的仅最远端之外,该垂直通槽穿过钉仓9020的纵向轴线。
如图211所示,当将拼合式刀和击发杆9090朝近侧牵拉直到向下的突出部9136将E型横梁9102上的中间导向装置9120向上和向后凸轮时,开始击发钉施用组件9012,从而当砧座9022如图203和207打开时,使新的钉仓9020插入钉槽9018中。在图212中,拼合式刀和击发杆9090已朝远侧被推进一小段距离,从而使得当夹子弹簧9144作用于层合渐缩的击发杆9094的向上的突出部9138时,向下的突出部9136落入下轨道9132的扩大孔9130中。中间导向装置9120防止由于抵靠在楔形滑动件9126的阶梯式中央构件9124上而产生的进一步的向下旋转,从而将E型横梁的中间销9112保持在中央击发凹槽9216内。在图213中,拼合式刀和击发杆9090已朝远侧被击发,从而推进楔形滑动件9126,以当将夹持在砧座9022和具有锋利刀刃9116的钉仓9020之间的组织9242切断时使钉9023成形。随后,在图214中,拼合式刀和击发杆9090回缩,使楔形滑动件9126在远侧定位。在图215中,中间销9112被允许向下平移到形成于钉槽9018(还可参见图208、图211)中的锁定凹槽9240内。因此,当楔形滑动件9126(未在图215中示出)没有在近侧定位(例如,钉仓9020缺失或钉仓9020耗尽)时,如果中间销9112遇到锁定凹槽9240的远侧边缘,则操作者将会接收到触觉指示。类似的外科缝合器械在2008年6月3日公布的美国专利7,380,696中有所公开,该专利的全部公开内容以引用方式并入本文。
在各种实施例中,如上所述,钉仓可包括仓体,该仓体包括多个在其中限定的钉腔。仓体可包括平台和顶部平台表面,其中每个钉腔可限定平台表面中的开口。还如上所述,钉可被定位在每个钉腔内,使得钉被储存在仓体内直到其从仓体被射出。在各种实施例中,在从仓体被射出之前,钉可被容纳在仓体内,使得钉不突出到平台表面上方。在此类实施例中,当钉被定位在平台表面下方时,可减少钉被损坏和/或过早接触靶组织的可能性。在各种情况下,钉可在未击发位置和击发位置之间运动。在未击发位置时,其不从仓体突出,在击发位置时,其已从仓体露出并可接触被定位在钉仓对面的砧座。在各种实施例中,砧座和/或限定于砧座内的钉成形凹坑可被定位成距平台表面上方一预定距离,使得当钉从仓体被部署时,钉变形至一预定的成形高度。在一些情况下,被捕获在砧座和钉仓之间的组织的厚度可变化,因此,较厚的组织可被捕获在某些钉内而较薄的组织可被捕获在某些其他钉内。在任一种情况下,由钉施加到组织的夹紧压力或紧压力例如可因钉而异,或在钉排的一端上的钉和钉排的另一端上的钉之间变化。在某些情况下,可控制砧座和钉仓平台之间的间隙,使得钉在每个钉内施加某一最小的夹紧压力。然而在一些此类情况下,在不同的钉内的夹紧压力的显著变化可能仍然存在。
在本文所述的各种实施例中,钉仓可包括如下装置:该装置用于对被从钉仓部署的钉捕获的组织的厚度进行补偿。在各种实施例中,参见图216,钉仓诸如钉仓10000例如可包括刚性的第一部分诸如支撑部分10010,以及可压缩的第二部分诸如厚度补偿件10020。在至少一个实施例中,首先参见图218,支撑部分10010可包括仓体、顶部平台表面10011和多个钉腔10012。其中,类似于上文所述,每个钉腔10012可限定平台表面10011中的开口。钉10030例如可被可移除地定位在每个钉腔10012中。在至少一个此类实施例中,首先参见图245并且如下文更详细所述,每个钉10030可包括基部10031和从基部10031延伸的一个或多个腿10032。在钉10030被部署之前,还如下文更详细所述,钉10030的基部10031可由定位在支撑部分10010内的钉驱动器支撑,并且同时,钉10030的腿10032可至少被部分容纳在钉腔10012内。在各种实施例中,钉10030可在未击发位置和击发位置之间被部署,使得腿10032运动穿过组织厚度补偿件10020,穿透组织厚度补偿件10020的顶部表面,穿透组织T,并且接触被定位在钉仓10000对面的砧座。当腿10032抵靠砧座变形时,每个钉10030的腿10032可捕获组织厚度补偿件10020的一部分以及每个钉10030内的组织T的一部分,并且将压缩力施加到组织。对上文进行进一步描述,可使每个钉10030的腿10032向下朝钉的基部10031变形,以形成钉截留区域10039,在该钉截留区域,组织T和组织厚度补偿件10020可被捕获。在各种情况下,钉截留区域10039可被限定在已变形的腿10032的内表面和基部10031的内表面之间。钉截留区域的尺寸可取决于若干因素,例如腿的长度、腿的直径、基部的宽度、和/或例如腿变形的程度。
在先前的实施例中,外科医生常常需要针对正被缝合的组织选择具有适当钉高度的合适的钉。例如,外科医生可选择高的钉与厚组织一起使用以及选择低的钉与薄组织一起使用。然而在一些情况下,正被缝合的组织不具有一致的厚度,因此,一些钉无法实现期望的击发构型。例如,图250示出了用于较薄组织中的较高的钉。现在参见图251,当组织厚度补偿件诸如组织厚度补偿件10020例如与薄组织一起使用时,例如较大的钉可成形为期望的击发构型。
由于组织厚度补偿件的压缩率,组织厚度补偿件可对捕获在每个钉内的组织的厚度进行补偿。更具体地,现在参见图245和图246,组织厚度补偿件诸如组织厚度补偿件10020,例如可根据钉截留区域10039内容纳的组织的厚度和/或类型来占据每个钉10030的钉截留区域10039的较大和/或较小的部分。例如,相较于较厚的组织T被捕获在钉10030内的情况,如果较薄的组织T被捕获在钉10030内,则组织厚度补偿件10020可占据钉截留区域10039的较大部分。相应地,相较于较薄的组织T被捕获在钉10030内的情况,如果较厚的组织T被捕获在钉10030内,则组织厚度补偿件10020可占据钉截留区域10039的较小部分。这样,组织厚度补偿件可补偿较薄组织和/或较厚组织,并确保压缩力被施加到组织,而不论或至少基本上不论被捕获在钉内的组织厚度如何。除了上文所述之外,组织厚度补偿件10020可对被捕获在不同钉10030内的不同类型或不同压缩率的组织进行补偿。现在参见图246,组织厚度补偿件10020可将压缩力施加到可包括血管V的血管组织T,并因此限制血液流过不太可压缩的血管V,但是仍然将期望的压缩力施加到周围的组织T。在各种情况下,对上文进行进一步描述,组织厚度补偿件10020还可补偿已变形的钉。参见图247,各种钉10030的变形可导致限定在此类钉内的较大的钉截留区域10039。由于组织厚度补偿件10020的回弹力,现在参见图248,即使被限定在已变形钉10030内的钉截留区域10039可被扩大,定位在该已变形钉10030内的组织厚度补偿件10020仍然可将足够的压缩力施加到组织T。在各种情况下,位于相邻钉10030中间的组织厚度补偿件10020可被已变形钉10030周围的适当成形的钉10030抵靠组织T偏置,并因此将压缩力施加到例如围绕和/或被捕获在已变形钉10030内的组织。在各种情况下,组织厚度补偿件可补偿不同的组织密度,所述不同的组织密度可例如由于分类、纤维区域、和/或先前已缝合或处理的组织而产生。
在各种实施例中,固定的或不可改变的组织间隙可被限定在支撑部分和砧座之间。因此不论被捕获在钉内的组织的厚度为何均可使钉变形至预定的高度。当组织厚度补偿件与这些实施例一起使用时,组织厚度补偿件可适应被捕获在砧座和支撑部分钉仓之间的组织,并且由于组织厚度补偿件的回弹力,组织厚度补偿件可将附加的压缩力施加到组织。现在参见图252-257,钉10030已成形为预定的高度H。参照图252,组织厚度补偿件没有被使用,并且组织T占据了整个钉截留区域10039。参照图259,组织厚度补偿件10020的一部分已被捕获在钉10030内,已将组织T压缩,并且已占据钉截留区域10039的至少一部分。现在参见图254,薄组织T已被捕获在钉10030内。在该实施例中,被压缩的组织T具有大约2/9H的高度,并且被压缩的组织厚度补偿件10020具有例如大约7/9H的高度。现在参见图255,具有中间厚度的组织T已被捕获在钉10030内。在该实施例中,被压缩的组织T具有大约4/9H的高度,并且被压缩的组织厚度补偿件10020具有例如大约5/9H的高度。现在参见图256,具有中间厚度的组织T已被捕获在钉10030内。在该实施例中,被压缩的组织T具有大约2/3H的高度,并且被压缩的组织厚度补偿件10020具有例如大约1/3H的高度。现在参见图255,厚组织T已被捕获在钉10030内。在该实施例中,被压缩的组织T具有大约8/9H的高度,并且被压缩的组织厚度补偿件10020具有例如大约1/9H的高度。在各种情况下,组织厚度补偿件可包括压缩高度,该压缩高度包括:例如大约10%的钉截留高度、大约20%的钉截留高度、大约30%的钉截留高度、大约40%的钉截留高度、大约50%的钉截留高度、大约60%的钉截留高度、大约70%的钉截留高度、大约80%的钉截留高度、和/或大约90%的钉截留高度。
在各种实施例中,钉10030可包括任何合适的未成形高度。在某些实施例中,钉10030可包括例如介于大约2mm和大约4.8mm之间的未成形高度。钉10030可包括例如大约2.0mm、大约2.5mm、大约3.0mm、大约3.4mm、大约3.5mm、大约3.8mm、大约4.0mm、大约4.1mm、和/或大约4.8mm的未成形高度。在各种实施例中,钉可变形的高度H可由支撑部分10010的平台表面10011和相对的砧座之间的距离来决定。在至少一个实施例中,平台表面10011和砧座的组织接触表面之间的距离可例如为大约0.097"。高度H还可由限定在砧座内的成形凹坑的深度决定。在至少一个实施例中,成形凹坑例如可具有从组织接触表面测量的深度。在各种实施例中,如下文更详细所述,钉仓10000还可包括钉驱动器。该钉驱动器可将钉10030朝砧座抬起,并在至少一个实施例中将钉抬起或“过度驱动”到平台表面10011上方。在此类实施例中,钉10030的成形高度H还可由钉10030被过度驱动的距离来决定。在至少一个此类实施例中,钉10030可被过度驱动例如大约.028",并且可导致钉10030被成形为例如大约0.189"的高度。在各种实施例中,钉10030可被成形为例如大约0.8mm、大约1.0mm、大约1.5mm、大约1.8mm、大约2.0mm、和/或大约2.25mm的高度。在某些实施例中,钉可被成形为例如大约2.25mm和大约3.0mm的高度。对上文进行进一步描述,钉的钉截留区域的高度可由钉的成形高度以及包括钉的线材的宽度和直径所决定。在各种实施例中,钉10030的钉截留区域10039的高度可包括钉的成形高度H减去线材的两个直径宽度。在某些实施例中,钉线材可包括例如大约0.0089"的直径。在各种实施例中,钉行可包括例如介于大约0.0069"和大约0.0119"的直径。在至少一个示例性实施例中,钉10030的成形高度H可为大约0.189",并且钉线材直径可为大约0.0089",从而例如产生大约0.171"的钉截留高度。
在各种实施例中,对上文进行进一步描述,组织厚度补偿件可包括未压缩的或预部署的高度,并且能够变形为多个压缩高度中的一个。在某些实施例中,组织厚度补偿件可包括例如大约0.125"的未压缩高度。在各种实施例中,组织厚度的补偿件可包括例如大于等于大约0.080"的未压缩高度。在至少一个实施例中,组织厚度补偿件可包括未压缩的或预部署的高度,该高度大于钉的未击发高度。在至少一个实施例中,组织厚度补偿件的未压缩的或预部署的高度可比钉的未击发高度例如高大约10%、高大约20%、高大约30%、高大约40%、高大约50%、高大约60%、高大约70%、高大约80%、高大约90%、和/或高大约100%。在至少一个实施例中,组织厚度补偿件的未压缩的或预部署的高度可比钉的未击发高度高例如至多大约100%。在某些实施例中,组织厚度补偿件的未压缩的或预部署的高度可比钉的未击发高度高例如超过100%。在至少一个实施例中,组织厚度补偿件可包括等于钉的未击发高度的未压缩高度。在至少一个实施例中,组织厚度补偿件可包括小于钉的未击发高度的未压缩高度。在至少一个实施例中,组织厚度补偿件的未压缩的或预部署的高度可比钉的未击发高度例如低大约10%、低大约20%、低大约30%、低大约40%、低大约50%、低大约60%、低大约70%、低大约80%、和/或低大约90%。在各种实施例中,可压缩的第二部分可包括未压缩高度,该未压缩高度高于正被缝合的组织T的未压缩高度。在某些实施例中,组织厚度补偿件可包括未压缩高度,该未压缩高度等于正被缝合的组织T的未压缩高度。在各种实施例中,组织厚度补偿件可包括未压缩高度,该未压缩高度低于正被缝合的组织T的未压缩高度。
如上所述,不论是厚组织还是薄组织被捕获在钉内,组织厚度补偿件均可在多个成形钉内被压缩。在至少一个示例性实施例中,可使钉行或钉排内的钉变形,使得每个钉的钉截留区域包括例如大约2.0mm的高度,其中组织T和组织厚度补偿件可被压缩到该高度以内。在某些情况下,组织T可包括在钉截留区域内的大约1.75mm的压缩高度,而组织厚度补偿件可包括在钉截留区域内的大约0.25mm的压缩高度,从而得到总计为例如大约2.0mm的钉截留区域高度。在某些情况下,组织T可包括在钉截留区域内的大约1.50mm的压缩高度,而组织厚度补偿件可包括在钉截留区域内的大约0.50mm的压缩高度,从而得到总计为例如大约2.0mm的钉截留区域高度。在某些情况下,组织T可包括在钉截留区域内的大约1.25mm的压缩高度,而组织厚度补偿件可包括在钉截留区域内的大约0.75mm的压缩高度,从而得到总计为例如大约2.0mm的钉截留区域高度。在某些情况下,组织T可包括在钉截留区域内的大约1.0mm的压缩高度,而组织厚度补偿件可包括在钉截留区域内的大约1.0mm的压缩高度,从而得到总计为例如大约2.0mm的钉截留区域高度。在某些情况下,组织T可包括在钉截留区域内的大约0.75mm的压缩高度,而组织厚度补偿件可包括在钉截留区域内的大约1.25mm的压缩高度,从而得到总计为例如大约2.0mm的钉截留区域高度。在某些情况下,组织T可包括在钉截留区域内的大约1.50mm的压缩高度,而组织厚度补偿件可包括在钉截留区域内的大约0.50mm的压缩高度,从而得到总计为例如大约2.0mm的钉截留区域高度。在某些情况下,组织T可包括在钉截留区域内的大约0.25mm的压缩高度,而组织厚度补偿件可包括在钉截留区域内的大约1.75mm的压缩高度,从而得到总计为例如大约2.0mm的钉截留区域高度。
在各种实施例中,对上文进行进一步描述,组织厚度补偿件可包括小于钉的击发高度的未压缩高度。在某些实施例中,组织厚度补偿件可包括等于钉的击发高度的未压缩高度。在某些其他实施例中,组织厚度补偿件可包括高于钉的击发高度的未压缩高度。在至少一个此类实施例中,组织厚度补偿件的未压缩高度可包括例如如下厚度:该厚度为成形钉高度的大约110%、成形钉高度的大约120%、成形钉高度的大约130%、成形钉高度的大约140%、成形钉高度的大约150%、成形钉高度的大约160%、成形钉高度的大约170%、成形钉高度的大约180%、成形钉高度的大约190%、和/或成形钉高度的大约200%。在某些实施例中,组织厚度补偿件可包括未压缩高度,该高度为钉的击发高度的两倍以上。在各种实施例中,组织厚度可包括压缩高度,该高度为例如成形钉高度的大约85%至大约150%。在各种实施例中,如上所述,组织厚度补偿件可被压缩成介于未压缩厚度和压缩厚度之间。在某些实施例中,组织厚度补偿件的压缩厚度可例如为其未压缩厚度的大约10%、其未压缩厚度的大约20%、其未压缩厚度的大约30%、其未压缩厚度的大约40%、其未压缩厚度的大约50%、其未压缩厚度的大约60%、其未压缩厚度的大约70%、其未压缩厚度的大约80%、和/或其未压缩厚度的大约90%。在各种实施例中,组织厚度补偿件的未压缩厚度可例如比其压缩厚度厚大约两倍、大约十倍、大约五十倍、和/或大约一百倍。在至少一个实施例中,组织厚度补偿件的压缩厚度可介于其未压缩厚度的大约60%至大约99%。在至少一个实施例中,组织厚度补偿件的未压缩厚度可比其压缩厚度厚至少50%。在至少一个实施例中,组织厚度补偿件的未压缩厚度可比其压缩厚度厚至多一百倍。在各种实施例中,可压缩的第二部分可为弹性的,或至少部分弹性的,并且可将组织T抵靠钉的变形腿偏置。在至少一个此类实施例中,可压缩的第二部分可在组织T和钉的基部之间弹性伸展,以便抵靠钉的腿推动组织T。在某些实施例中,如下文将进一步详细讨论,组织厚度补偿件可被定位在组织T和变形的钉腿中间。在各种情况下,由于上文所述,组织厚度补偿件能够消除钉截留区域内的任何间隙。
在各种实施例中,组织厚度补偿件可包括聚合物组合物。聚合物组合物可包括一种或多种合成聚合物和/或一种或多种非合成聚合物。合成聚合物可包括合成的可吸收聚合物和/或合成的非可吸收聚合物。在各种实施例中,聚合物组合物可包括例如生物相容性泡沫。生物相容性泡沫可包括例如多孔的开孔泡沫和/或多孔的闭孔泡沫。生物相容性泡沫可具有均匀的孔形态或可具有梯度孔形态(即,在一个方向的整个泡沫厚度上,小孔尺寸逐渐增加变成大孔)。在各种实施例中,聚合物组合物可包括多孔支架、多孔基质、凝胶基质、水凝胶基质、溶液基质、丝状基质、管状基质、复合基质、膜基质、生物稳定聚合物和可生物降解的聚合物中的一种或多种、以及它们的组合。例如,组织厚度补偿件可包括通过丝状基质增强的泡沫,或可包括具有附加的水凝胶层的泡沫,该附加的水凝胶层在体液存在下扩展,以在组织上进一步提供压缩。在各种实施例中,组织厚度补偿件还可由材料和/或第二层或第三层上的涂层构成,该涂层在体液存在下扩展,以在组织上进一步提供压缩。此类层可为水凝胶,该水凝胶可为合成的和/或天然源材料,并且例如可为生物耐用的和/或可生物降解的。在某些实施例中,可使用能提供附加柔韧性、刚度、和/或强度的纤维非织造材料或纤维网眼类型元件来增强组织厚度补偿件。在各种实施例中,组织厚度补偿件具有多孔形态,该多孔形态表现出梯度结构,例如在一个表面上的小孔以及在另一个表面上的较大的孔。此类形态对于组织生长或止血行为而言更为理想。此外,梯度还可与变化的生物吸收剖面相组合。短期吸收剖面可为优选的,以解决止血问题,而长期吸收剖面可解决无渗漏情况下使组织更好愈合的问题。
非合成聚合物的例子包括但不限于冻干多糖、糖蛋白类、弹性蛋白、蛋白聚糖、明胶、胶原和氧化再生纤维素(ORC)。合成的可吸收聚合物的例子包括但不限于聚(乳酸)(PLA)、聚(L-乳酸)(PLLA)、聚己内酯(PCL)、聚乙醇酸(PGA)、聚(三亚甲基碳酸酯)(TMC)、聚对苯二甲酸乙二酯(PET)、多羟基链烷酸酯(PHA)、乙交酯和ε-己内酯(PGCL)的共聚物、乙交酯和三亚甲基碳酸酯的共聚物、聚(癸二酸甘油酯)(PGS)、聚对二氧环己酮、聚(原酸酯)、聚酸酐、多糖、聚(酯-酰胺)、酪氨酸基聚芳酯、酪氨酸基聚亚氨碳酸酯、酪氨酸基聚碳酸酯、聚(D,L-丙交酯-氨基甲酸酯)、聚(B-羟基丁酸)、聚(E-己内酯)、聚乙二醇(PEG)、聚[二(羧基苯氧基)磷腈]、聚(氨基酸)、拟聚(氨基酸)、可吸收的聚氨酯以及它们的组合。在各种实施例中,聚合物组合物可包括例如按重量计大约50%到大约90%的PLLA的聚合物组合物,以及按重量计大约50%到大约10%的PCL的聚合物组合物。在至少一个实施例中,聚合物组合物可包括例如按重量计大约70%的PLLA,以及按重量计大约30%的PCL。在各种实施例中,聚合物组合物可包括例如按重量计大约55%到大约85%的PGA的聚合物组合物,以及按重量计15%到45%的PCL的聚合物组合物。在至少一个实施例中,聚合物组合物可包括例如按重量计大约65%的PGA,以及按重量计大约35%的PCL。在各种实施例中,聚合物组合物可包括例如按重量计大约90%到大约95%的PGA的聚合物组合物,以及按重量计大约5%到大约10%的PLA的聚合物组合物。
在各种实施例中,合成的可吸收聚合物可包括可生物吸收的、生物相容性弹性体共聚物。合适的可生物吸收的、生物相容性弹性体共聚物包括但不限于ε-己内酯和乙交酯的共聚物(优选地ε-己内酯与乙交酯的摩尔比为约30:70至约70:30,优选地35:65至约65:35,还更优选地45:55至35:65)、ε-己内酯和丙交酯(包括其L-丙交酯、D-丙交酯共混物或乳酸共聚物)的弹性体共聚物(优选地ε-己内酯与丙交酯的摩尔比为约35:65至约65:35,还更优选地45:55至30:70)、对二氧杂环己酮(1,4-二氧杂环己烷-2-酮)和丙交酯(包括L-丙交酯、D-丙交酯和乳酸)的弹性体共聚物(优选地对二氧杂环己酮与丙交酯的摩尔比为约40:60至约60:40)、ε-己内酯和对二氧杂环己酮的弹性体共聚物(优选地ε-己内酯与对二氧杂环己酮的摩尔比为约30:70至约70:30)、对二氧杂环己酮和三亚甲基碳酸酯的弹性体共聚物(优选地对二氧杂环己酮与三亚甲基碳酸酯的摩尔比为约30:70至约70:30)、三亚甲基碳酸酯和乙交酯的弹性体共聚物(优选地三亚甲基碳酸酯与乙交酯的摩尔比为约30:70至约70:30)、三亚甲基碳酸酯和丙交酯(包括其L-丙交酯、D-丙交酯共混物或乳酸共聚物)的弹性体共聚物(优选地三亚甲基碳酸酯与丙交酯的摩尔比为约30:70至约70:30)及其共混物。在一个实施例中,弹性体共聚物为乙交酯和ε-己内酯的共聚物。在另一个实施例中,弹性体共聚物为丙交酯和ε-己内酯的共聚物。
公布于1995年11月21日的名称为“ELASTOMERIC MEDICALDEVICE”的美国专利5,468,253以及公布于2001年12月4日的名称为“FOAM BUTTRESS FOR STAPLING APPARATUS”用于的美国专利6,325,810的公开内容各自全文以引用的方式并入本文。
在各种实施例中,合成的可吸收聚合物可包括例如可以商标名称VICRYL(polyglactic910)从Ethicon,Inc.商购获得的90/10聚(乙交酯-L-丙交酯)共聚物、可以商标名称DEXON从American Cyanamid Co.商购获得的聚乙交酯、可以商标名称PDS从Ethicon,Inc.商购获得的聚对二氧环己酮、可以商标名称MAXON从American Cyanamid Co.商购获得的聚(乙交酯-三亚甲基碳酸酯)无规嵌段共聚物、可以商标名称MONOCRYL从爱惜康公司商购获得的75/25聚(乙交酯-E-己内酯-poliglecaprolactone25)共聚物中的一种或多种。
合成的非可吸收聚合物包括但不限于聚氨酯泡沫塑料、聚丙烯(PP)、聚乙烯(PE)、聚碳酸酯、聚酰胺,例如尼龙、聚氯乙烯(PVC)、聚甲基丙烯酸甲酯(PMMA)、聚苯乙烯(PS)、聚酯、聚醚醚酮(PEEK)、聚四氟乙烯(PTFE)、聚三氟氯乙烯(PTFCE)、聚氟乙烯(PVF)、氟化乙烯丙烯(FEP)、聚缩醛、聚砜、以及它们的组合。合成的非可吸收聚合物可包括但不限于弹性体泡沫塑料和多孔弹性体,例如硅氧烷、聚异戊二烯和橡胶。在各种实施例中,合成聚合物可包括膨体聚四氟乙烯(ePTFE)(可以商标名称GORE-TEX Soft Tissue Patch从戈尔公司(W.L.Gore&Associates,Inc.)商购获得)和共聚醚酯聚氨酯泡沫(可以商标名称NASOPORE从Polyganics商购获得)。
组织厚度补偿件的聚合物组合物的特征在于例如百分孔隙率、孔尺寸、和/或硬度。在各种实施例中,聚合物组合物可具有例如按体积计大约30%到大约99%的百分孔隙率。在某些实施例中,聚合物组合物可具有例如按体积计大约60%到大约98%的百分孔隙率。在各种实施例中,聚合物组合物可具有例如按体积计大约85%到大约97%的百分孔隙率。在至少一个实施例中,聚合物组合物可包括例如按重量计大约70%的PLLA和按重量计大约30%的PCL,并且可包括例如按体积计大约90%的孔隙率。在至少一个此类实施例中,因此,聚合物组合物将包括按体积计大约10%的共聚物。在至少一个实施例中,聚合物组合物可包括例如按重量计大约65%的PGA和按重量计大约35%的PCL,并且可具有例如按体积计大约93%到按体积计大约95%的百分孔隙率。在各种实施例中,聚合物组合物可包括按体积计大于85%的孔隙率。聚合物组合物可具有例如大约5微米到大约2000微米的孔尺寸。在各种实施例中,聚合物组合物可具有例如介于大约10微米到大约100微米之间的孔尺寸。在至少一个此类实施例中,聚合物组合物可例如包括PGA和PCL的共聚物。在某些实施例中,聚合物组合物可具有例如介于大约100微米到大约1000微米之间的孔尺寸。在至少一个此类实施例中,聚合物组合物可包括例如PLLA和PCL的共聚物。根据某些方面,聚合物组合物的硬度可以肖氏硬度表示。该肖氏硬度可被定义为诸如由肖氏硬度计所测定的对材料的永久凹痕的耐受性。为了评估给定材料的硬度计值,根据名称为“Standard Test Method for Rubber Property-Durometer Hardness”(橡胶特性-硬度计硬度的标准测试方法)的ASTM程序D2240-00,用硬度计压头脚将压力施加至材料,其全文以引用的方式并入本文。可将硬度计压头脚施用到材料并持续足够的一段时间,诸如15秒,例如,其中读数从合适的标度读取。根据所用的标度类型,当压头脚完全穿透材料时,可获得读数0,并且当材料未被穿透时,可获得读数100。该读数无量纲。在各种实施例中,可例如根据ASTM D2240-00根据任何合适的标度诸如A类和/或OO类标度来决定硬度计。在各种实施例中,组织厚度补偿件的聚合物组合物可具有大约4A到大约16A的肖氏A硬度值,该肖氏A硬度值例如在大约45OO到大约65OO的肖氏OO范围。在至少一个此类实施例中,聚合物组合物可包括例如PLLA/PCL共聚物或PGA/PCL共聚物。在各种实施例中,组织厚度补偿件的聚合物组合物可具有小于15A的肖氏A硬度值。在各种实施例中,组织厚度补偿件的聚合物组合物可具有小于10A的肖氏A硬度值。在各种实施例中,组织厚度补偿件的聚合物组合物可具有小于5A的肖氏A硬度值。在某些实施例中,聚合物材料可具有例如大约35OO到大约75OO的肖氏OO组合物值。
在各种实施例中,聚合物组合物可具有上述识别出的特性中的至少两种。在各种实施例中,聚合物组合物可具有上述识别出的特性中的至少三种。聚合物组合物可具有例如按体积计85%到97%的孔隙率、5微米到2000微米的孔尺寸、和4A到16A的肖氏A硬度值以及45OO到65OO的肖氏OO硬度值。在至少一个实施例中,聚合物组合物可包括70重量%的PLLA的聚合物组合物以及30重量%的PCL的聚合物组合物;所述聚合物组合物具有例如按体积计90%的孔隙率、100微米到1000微米的孔尺寸、和4A到16A的肖氏A硬度值以及45OO到65OO的肖氏OO硬度值。在至少一个实施例中,聚合物组合物可包括65重量%的PGA的聚合物组合物以及35重量%的PCL的聚合物组合物;所述聚合物组合物具有例如按体积计93%到95%的孔隙率、10微米到100微米的孔尺寸、和4A到16A的肖氏A硬度值以及45OO到65OO的肖氏OO硬度值。
在各种实施例中,聚合物组合物可包括药物活性剂。聚合物组合物可释放治疗有效量的药物活性剂。在各种实施例中,当聚合物组合物被解吸或吸收时药物活性剂可被释放。在各种实施例中,药物活性剂可被释放到流体诸如流经聚合物组合物之上或穿过聚合物组合物的血液中。药物活性剂的例子可包括但不限于止血剂和药物,例如纤维蛋白、凝血酶和氧化再生纤维素(ORC);抗炎药,例如双氯芬酸、阿司匹林、萘普生、舒林酸和氢化可的松;抗生素和抗微生物药物或试剂,例如三氯生、离子银、氨苄青霉素、庆大霉素、多粘菌素B、氯霉素;以及抗癌剂,例如顺铂、丝裂霉素、阿霉素。
在各种实施例中,现在参见图216,钉仓诸如钉仓10000例如可包括支撑部分10010和可压缩的组织厚度补偿件10020。现在参见图218-220,支撑部分10010可包括平台表面10011和限定在支撑部分10010中的多个钉腔10012。每个钉腔10012的尺寸例如可设定成并能够在其中可移除地储存钉诸如钉10030。钉仓10000还可包括多个钉驱动器10040。当钉10030和钉驱动器10040处于其未击发位置时,每个钉驱动器能够支撑钉腔10012内的一个或多个钉10030。在至少一个此类实施例中,首先参见图224和图225,每个钉驱动器10040可包括例如一个或多个支架或槽10041,该支架或槽能够支撑钉并限制钉10030和钉驱动器10040之间的相对运动。在各种实施例中,再次参见图218,钉仓10000还可包括钉击发滑动件10050;该钉击发滑动件可从钉仓的近端10001运动到钉仓的远端10002,以便依次将钉驱动器10040和钉10030从其未击发位置朝向被定位在钉仓10000对面的砧座抬起。在某些实施例中,首先参见图218和图220,每个钉10030可包括基部10031和从基部10031延伸的一个或多个腿10032,其中每个钉例如可为基本U形和基本V形中的至少一者。在至少一个实施例中,钉10030可被配置成使得当钉10030处于其未击发位置时,钉腿10032的末端相对于支撑部分10010的平台表面10011凹陷。在至少一个实施例中,钉10030可被配置成使得当钉10030处于其未击发位置时,钉腿10032的末端相对于支撑部分10010的平台表面10011齐平。在至少一个实施例中,钉10030可被配置成使得当钉10030处于其未击发位置时,钉腿10032的末端或钉腿10032的至少某部分延伸到支撑部分10010的平台表面10011上方。在此类实施例中,当钉10030处于其未击发位置时,钉腿10032可延伸到并被嵌入到组织厚度补偿件10020中。在至少一个此类实施例中,钉腿10032可例如延伸到平台表面10011上方大约0.075"。在各种实施例中,钉腿10032可例如延伸到平台表面10011上方大约0.025"和大约0.125"之间的距离。在某些实施例中,对上文进行进一步描述,组织厚度补偿件10020可包括例如大约0.08"和大约0.125"之间的未压缩厚度。
在使用中,对上文进行进一步描述并首先参见图233,砧座诸如砧座10060例如可运动到与钉仓10000相对的闭合位置。如下文更详细所述,砧座10060可将组织抵靠组织厚度补偿件10020定位,并且在各种实施例中,例如将组织厚度补偿件10020压向支撑部分10010的平台表面10011。一旦砧座10060已被恰当定位,则可部署钉10030,同样如图233所示。在各种实施例中,如上所述,钉击发滑动件10050可从钉仓10000的近端10001朝向远端10002运动,如图234所示。当滑动件10050被推进时,滑动件10050可接触钉驱动器10040并在钉腔10012内将钉驱动器10040向上抬起。在至少一个实施例中,滑动件10050和钉驱动器10040可各自包括一个或多个斜坡或斜面,该一个或多个斜坡或斜面可协作以使钉驱动器10040从其未击发位置向上运动。在至少一个此类实施例中,参见图221-225,每个钉驱动器10040可包括至少一个斜面10042,并且滑动件10050可包括一个或多个斜面10052,其可被配置成使得当滑动件10050在钉仓内朝远侧被推进时,斜面10052在斜面10042下滑动。当钉驱动器10040在其各自的钉腔10012内被向上抬起时,钉驱动器10040可将钉10030向上抬起,使得钉10030可通过钉平台10011中的开口从其钉腔10012中露出。在示例性击发序列期间,首先参见图227-229,滑动件10050可首先接触钉10030a并且开始将钉10030a向上抬起。当滑动件10050朝远侧被进一步推进时,滑动件10050可开始将钉10030b,10030c,10030d,10030e和10030f以及任何其他后续钉顺序抬起。如图229所示,滑动件10050可将钉10030向上驱动,使得与相对的砧座接触的钉的腿10032变形至期望的形状,并且从支撑部分10010被射出。在各种情况下,作为击发序列的一部分,滑动件10030可同时将多个钉向上运动。参照图229所示的击发序列,钉10030a和10030b已运动至其完全击发位置并且从支撑部分10010被射出,钉10030c和10030d处于被击发的过程中并且被至少部分地容纳在支撑部分10010内,并且钉10030e和10030f仍然处于其未击发位置。
如上所述并参见图235,当钉10030处于其未击发位置时,钉10030的钉腿10032可延伸到支撑部分10010的平台表面10011上方。进一步参照图229所示的击发序列,钉10030e和10030f示出为处于其未击发位置,并且其钉腿10032延伸到平台表面10011上方并且延伸到组织厚度补偿件10020中。在各种实施例中,当钉10030处于其未击发位置时,钉腿10032的末端或钉腿10032的任何其他部分可能不凸穿组织厚度补偿件10020的顶部组织接触表面10021。如图229所示,当钉10030从其未击发位置运动到其击发位置时,钉腿的末端可凸穿组织接触表面10032。在各种实施例中,钉腿10032的末端可包括能够切割和穿透组织厚度补偿件10020的锐利末端。在某些实施例中,组织厚度补偿件10020可包括多个孔,该多个孔能够容纳钉腿10032并且使钉腿10032相对于组织厚度补偿件10020滑动。在某些实施例中,支撑部分10010还可包括从平台表面10011延伸的多个导向装置10013。导向装置10013可被定位成邻近平台表面10011的钉腔开口,使得钉腿10032可至少部分地由导向装置10013支撑。在某些实施例中,导向装置10013可被定位在钉腔开口的近端和/或远端处。在各种实施例中,第一导向装置10013可被定位在每个钉腔开口的第一端部,并且第二导向装置10013可被定位在每个钉腔开口的第二端部,使得每个第一导向装置10013可支撑钉10030的第一钉腿10032,并且每个第二导向装置10013可支撑钉的第二钉腿10032。在至少一个实施例中,参见图235,每个导向装置10013可包括沟槽或狭槽,例如沟槽10016;钉腿10032例如可被滑动地容纳在该沟槽中。在各种实施例中,每个导向装置10013可包括可从平台表面10011延伸并可延伸到组织厚度补偿件10020中的夹板、突起、和/或长钉。在至少一个实施例中,如下文更详细所述,夹板、突起、和/或长钉可减少组织厚度补偿件10020和支撑部分10010之间的相对运动。在某些实施例中,钉腿10032的末端可被定位在导向装置10013中,并且当钉10030处于其未击发位置时可不延伸到导向装置10013的顶部表面上方。在至少此类实施例中,导向装置10013可限定导向高度,并且当钉10030不处于其未击发位置时可不延伸到该导向高度上方。
在各种实施例中,组织厚度补偿件诸如组织厚度补偿件10020,例如可由单个材料片构成。在至少一个实施例中,组织厚度补偿件可包括连续材料片,该连续材料片可覆盖支撑部分10010的整个顶部平台表面10011,或者覆盖少于整个平台表面10011。在某些实施例中,材料片可覆盖支撑部分10010中的钉腔开口,而在其他实施例中,材料片可包括可与钉腔开口对齐的或至少部分对齐的开口。在各种实施例中,组织厚度补偿件可由多层材料构成。在一些实施例中,现在参见图217,组织厚度补偿件可包括可压缩芯和围绕可压缩芯的包裹物。在某些实施例中,包裹物10022能够将可压缩芯可释放地保持到支撑部分10010。在至少一个此类实施例中,支撑部分10010可包括例如从其延伸的一个或多个突出部,诸如突出部10014(图220),该突出部可容纳在一个或多个孔和/或狭槽内,例如限定在包裹物10022中的孔10024内。突出部10014和孔10024可被配置成使得突出部10014可将包裹物10022保持到支撑部分10010。在至少一个实施例中,突出部10014的端部可例如通过热熔处理而变形,以便扩大突出部10014的端部,并因此限制包裹物10022和支撑部分10010之间的相对运动。在至少一个实施例中,包裹物10022可包括一个或多个穿孔10025,其可有利于将包裹物10022从支撑部分10010释放,如图217所示。现在参见图226,组织厚度补偿件可包括包裹物10222,该包裹物包括多个孔10223,其中孔10223可与支撑部分10010中的钉腔开口对齐或至少部分对齐。在某些实施例中,组织厚度补偿件的芯还可包括与包裹物10222中的孔10223对齐或至少部分对齐的孔。在其他实施例中,组织厚度补偿件的芯可包括连续主体并可延伸到孔10223的下面,使得连续主体覆盖平台表面10011中的钉腔开口。
在各种实施例中,如上所述,组织厚度补偿件可包括用于将可压缩芯可释放地保持到支撑部分10010的包裹物。在至少一个此类实施例中,参见图218,钉仓还可包括保持器夹具10026,该保持器夹具能够抑制包裹物和可压缩芯过早地与支撑部分10010分离。在各种实施例中,每个保持器夹具10026可包括能够容纳从支撑部分10010延伸的突出部10014的孔10028,使得保持器夹具10026可被保持到支撑部分10010。在某些实施例中,保持器夹具10026可各自包括至少一个盘部分10027,该盘部分可延伸到支撑部分10010的下面并可将钉驱动器10040支撑并保持在支撑部分10010内。在某些实施例中,如上所述,组织厚度补偿件可通过钉10030可移除地附接至支撑部分10010。更具体地,还如上所述,当钉10030处于其未击发位置时,钉10030的腿可延伸到组织厚度补偿件10020中,并因此将组织厚度补偿件10020可释放地保持到支撑部分10010。在至少一个实施例中,钉10030的腿可与其相应的钉腔10012的侧壁接触,其中,由于钉腿10032和侧壁之间的摩擦,钉10030和组织厚度补偿件10020可被保持就位,直到钉10030从钉仓10000被部署。当钉10030被部署后,组织厚度补偿件10020可被捕获在钉10030内并且抵靠缝合的组织T被保持。当砧座随后运动到打开位置以释放组织T时,支撑部分10010可运动远离已固定至组织的组织厚度补偿件10020。在某些实施例中,可使用粘合剂以将组织厚度补偿件10020可移除地保持到支撑部分10010。在至少一个实施例中,可使用两部分粘合剂,其中在至少一个实施例中,粘合剂的第一部分可被放置到平台表面10011上,并且粘合剂的第二部分可被放置到组织厚度补偿件10020上,使得当组织厚度补偿件10020紧贴平台表面10011放置时,第一部分可接触第二部分以启用粘合剂并将组织厚度补偿件10020可分离地粘结至支撑部分10010。在各种实施例中,可使用任何其他合适的方法将组织厚度补偿件可分离地保持到钉仓的支撑部分。
在各种实施例中,对上文进行进一步描述,滑动件10050可从近端10001被推进到远端10002以完全部署被容纳在钉仓10000内的所有钉10030。在至少一个实施例中,现在参见图258-262,滑动件10050可在支撑部分10010内在纵向腔体10016中由击发构件或外科缝合器的刀杆10052朝远侧推进。在使用中,钉仓10000可被插入外科缝合器的钳口中的钉仓通道内,例如钉仓通道10070内,并且击发构件10052可被推进到与滑动件10050接触,如图258所示。当滑动件10050由击发构件10052朝远侧推进时,滑动件10050可接触最近侧的钉驱动器或驱动器10040,并且将钉10030从仓体10010击发或射出,如上所述。如图258所示,击发构件10052还可包括切刃10053,当钉10030被击发时,该切刃可通过支撑部分10010中的刀狭槽朝远侧被推进。在各种实施例中,相应的刀狭槽可延伸穿过被定位在钉仓10000对面的砧座,使得在至少一个实施例中,切刃10053可在砧座和支撑部分10010之间延伸并切割被定位在其间的组织和组织厚度补偿件。在各种情况下,滑动件10050可由击发构件10052朝远侧推进,直到滑动件10050到达钉仓10000的远端10002,如图260所示。此时,击发构件10052可朝近侧回缩。在一些实施例中,滑动件10050可随击发构件10052朝近侧回缩,但是在各种实施例中,现在参见图261,当击发构件10052回缩时,滑动件10050可被留在钉仓10000的远端10002中。一旦击发构件10052已充分回缩,砧座可被再次打开,组织厚度补偿件10020可与支撑部分10010分离,并且已耗尽钉仓10000的剩余的非植入部分,包括支撑部分10010,可从钉仓通道10070中被移除。
当已耗尽钉仓10000已从钉仓通道中被移除后,对上文进行进一步描述,新的钉仓10000或任何其他合适的钉仓可被插入钉仓通道10070中。在各种实施例中,对上文进行进一步描述,钉仓通道10070、击发构件10052、和/或钉仓10000可包括协作结构,该协作结构可在新的未击发钉仓10000没有被定位在钉仓通道10070中时防止击发构件10052再次或后续次朝远侧被推进。更具体地,再次参见图258,当击发构件10052被推进到与滑动件10050接触时,并且当滑动件10050处于其近侧未击发位置时,击发构件10052的支撑鼻部10055可被定位在滑动件10050上的支撑凸缘10056上和/或之上,使得击发构件10052被保持在足够向上的位置,以防止从击发构件10052延伸的锁或横梁10054落入被限定在钉仓通道内的锁凹槽中。由于锁10054不会落入锁凹槽时,在此类情况下,当击发构件10052被推进时,锁10054可不邻接锁凹槽的远侧侧壁10057。当击发构件10052将滑动件10050朝远侧推动时,击发构件10052可由于靠在支撑凸缘10056上的支撑鼻部10055而被支撑在其向上击发位置。当击发构件10052相对于滑动件10050回缩时,如上所述并如图261所示,当支撑鼻部10055不再靠在滑动件10050的支撑凸缘10056上时,击发构件10052可从其向上位置下落。在至少一个此类实施例中,外科钉可包括能够将击发构件10052偏置到其向下位置的弹簧10058和/或任何其他合适的偏置元件。一旦击发构件10052已完全回缩,如图262所示,击发构件10052不能再次穿过用尽的钉仓10000朝远侧被推进。更具体地,当此时处于操作顺序的滑动件10050已被留在钉仓10000的远端10002处时,击发构件10052不能被滑动件10050保持在其上部位置。因此,如上所述,如果击发构件10052在没有替换钉仓的情况下被再次推进,则锁横梁10054将接触锁凹槽的侧壁10057,这将防止击发构件10052再次朝远侧被推进到钉仓10000中。换句话讲,一旦用尽的钉仓10000已被新的钉仓替换,新的钉仓将具有近侧定位的滑动件10050,该近侧定位的滑动件可将击发构件10052保持在其向上位置,并且使击发构件10052再次朝远侧被推进。
如上所述,滑动件10050能够将钉驱动器10040在第一未击发位置和第二击发位置之间运动,以便将钉10030从支撑部分10010中射出。在各种实施例中,在钉10030已从支撑部分10010被射出时,钉驱动器10040可被容纳在钉腔10012内。在某些实施例中,支撑部分10010可包括能够阻止钉驱动器10040从钉腔10012中射出或掉出的一个或多个保持结构。在各种其他实施例中,滑动件10050能够将钉驱动器10040从具有钉10030的支撑部分10010中射出。在至少一个此类实施例中,钉驱动器10040可由例如可生物吸收的和/或生物相容性材料构成,诸如聚醚酰亚胺。在某些实施例中,钉驱动器可附接到钉10030。在至少一个此类实施例中,钉驱动器可被模制在每个钉10030的基部之上和/或周围,使得驱动器与钉一体成型。2006年9月29日提交的名称为“SURGICAL STAPLESHAVING COMPRESSIBLE OR CRUSHABLE MEMBERS FOR SECURINGTISSUE THEREIN AND STAPLING INSTRUMENTS FOR DEPLOYINGTHE SAME”美国专利申请序列号11/541,123全文以引用方式并入本文。
在各种实施例中,对上文进行进一步描述,可压缩的组织厚度补偿件可相对于钉仓的下面的刚性支撑部分运动、扭曲、和/或偏转。在各种实施例中,支撑部分和/或钉仓的任何其他合适的部分可包括能够限制组织厚度补偿件和支撑部分之间相对运动的一个或多个结构。如上所述,钉10030的至少一部分可延伸到支撑部分10010的平台表面10011上方,其中,在某些情况下,现在参见图263和图264,施加到组织厚度补偿件10120的侧向力例如可被从支撑部分10010延伸的钉10030和/或夹板10013抵挡。在各种情况下,钉10030在抵挡组织厚度补偿件10120的侧向运动时可在钉腔10012内倾斜和/或弯曲,其中在各种实施例中,钉腔10012和钉10030的尺寸可设定成并且能够保持钉10030的腿10032和相对的砧座10060中的成形凹坑10062之间的相对对齐,使得钉10000在钉成形过程期间正确成形。在各种实施例中,钉10030和/或夹板10013能够防止或至少限制组织厚度补偿件10020内的侧向扭曲,如图264所示。在至少一个此类实施例中,钉10030和/或夹板10013例如能够加强或限制组织厚度补偿件的第一或组织接触表面10021相对于第二或底部表面10029的侧向和/或纵向运动。在各种实施例中,钉仓和/或其中定位有钉仓的钉仓通道可包括至少一个扭曲最小化构件,该扭曲最小化构件可向上延伸以限制组织厚度补偿件的侧向和/或纵向运动或扭曲。如上所述,至少部分地围绕组织厚度补偿件的包裹物也可防止或至少限制组织厚度补偿件的侧向和/或纵向运动或扭曲。
在各种实施例中,再次参见图263和264,组织厚度补偿件诸如组织厚度补偿件10120例如可包括芯10128和外皮10122。外皮10122和可压缩芯10128可由不同材料或相同材料构成。在任一种情况下,外皮10122可具有比芯10128更高的密度。在外皮10122包括组织厚度补偿件10120的顶部的情况下,钉腿10032的末端可嵌入外皮10122中。在外皮包括组织厚度补偿件10120的底部的实施例中,钉腿10032可延伸穿过外皮并进入芯中。在任一种情况下,组织厚度补偿件的外皮可有助于保持钉腿10032与砧座10060的成形凹坑10062对齐。在各种实施例中,外皮10122可包括如下密度:该密度例如比芯10128的密度大大约10%、比芯10128的密度大大约20%、比芯10128的密度大大约30%、比芯10128的密度大大约40%、比芯10128的密度大大约50%、比芯10128的密度大大约60%、比芯10128的密度大大约70%、比芯10128的密度大大约80%、比芯10128的密度大大约90%、比芯10128的密度大大约100%。在各种实施例中,外皮10122可包括如下密度,该密度例如大于芯10128的密度并且小于芯10128的密度的两倍。在各种实施例中,外皮10122可包括如下密度,该密度例如大于芯10128的密度的两倍。在各种实施例中,对上文进行进一步描述,外皮10122和芯10128可同时被成形或制造。在至少一个此类实施例中,包含本文所公开的任何合适材料的流体可被倒入碟中或被模制,并且当流体凝固时,流体可形成具有比剩余材料更高密度的外皮或层。在各种实施例中,材料中的多个层可通过使用如下方法形成:在该方法中,材料的一个或多个后续层被倾倒到先前固化的层上。在某些实施例中,两个或更多个层可例如通过粘合剂彼此粘合。在一些实施例中,两个或更多个层可例如通过一个或更多个紧固件和/或一个或更多个机械互锁结构附接到彼此。在至少一个此类实施例中,相邻层可例如通过一个或更多个燕尾接合连接在一起。在某些实施例中,外皮可包括可防止或至少限制流体穿过其中流动的密封表面。在某些其他实施例中,外皮可包括例如开孔的多孔结构。
在各种实施例中,对上文进行进一步描述,可从组织厚度补偿件剪掉外皮。在至少一个实施例中,组织厚度补偿件可从较大的材料块切除,使得组织厚度补偿件不包括外皮。在至少一个此类实施例中,组织厚度补偿件可由例如包括大孔的同质或至少基本上同质的材料构成。
在各种实施例中,钉仓可包括多个钉腔,每个钉腔容纳定位在其中的钉,其中钉腔可被布置成多行,并且其中被定位在钉仓对面的砧座可包括与钉仓中的钉腔对应的多个成形凹坑。换句话讲,砧座可包括多个成形凹坑行,其中每个成形凹坑可被定位在钉仓中的钉腔的对面。在各种实施例中,每个成形凹坑可包括能够容纳钉10030的钉腿10032的两个成形杯,其中每个成形杯能够容纳钉腿10032,并且使钉腿10032例如朝向其他钉腿10032成形或卷曲。在各种情况下,腿10032可能缺少成形杯或没有正确地进入成形杯,因此钉腿10032可能在击发序列期间发生变形。在本文所述的各种实施例中,砧座可包括成形凹坑阵列或网格,其各自能够容纳并形成钉腿。在至少一个此类实施例中,成形凹坑阵列可包括一些成形凹坑,该成形凹坑的数量超过钉仓内容纳的钉的数量。在至少一个实施例中,钉仓可包括例如六个纵向行的钉腔,其中砧座可包括与六行钉腔对齐的六行成形凹坑,并且此外成形凹坑被定位在成形凹坑行的中间。例如,在砧座的一侧上,砧座可包括可被定位在第一排钉腔之上的第一排成形凹坑、可被定位在邻近第一排钉腔的第二排钉腔之上的第二排成形凹坑、以及此外被定位在第一排成形凹坑和第二排成形凹坑中间的一排成形凹坑。在各种实施例中,现在参见图276-279,砧座10260可包括六排成形凹坑10261,其能够被放置在钉仓10200中的相应的六排钉腔之上。在至少一个此类实施例中,多排中间成形凹坑10262可被定位在多排成形凹坑10261中间和/或邻近多排成形凹坑10261。在某些实施例中,现在参见图277、图278和图280,每个成形凹坑10261和10262可包括两个成形杯,其中每个成形杯包括能够使钉腿10032朝近侧成形或卷曲的远侧部分10263以及能够使钉腿10032朝远侧成形或卷曲的近侧部分10264。在各种其他情况下,钉10030可通过多种其他方式成形。例如,钉10030可成形为使得一个腿10032向外成形并且另一个腿10032向内成形(图281),或是的两个腿10032都向外成形(图282),这取决于例如1)钉腿10032进入那个成形杯,和/或2)腿10032是否进入每个成形杯的近侧部分10263或远侧部分10064。
在各种实施例中,对上文进行进一步描述,每个成形凹坑10261和/或成形凹坑10262可包括例如三角形或菱形形状。在至少一个实施例中,成形凹坑的每个远侧部分10263和/或每个近侧部分10264可包括三角形形状,其中在至少一个此类实施例中,远侧部分10263和近侧部分10264的三角形形状可被布置成使得其具有指向相对方向的顶点。在某些实施例中,砧座可包括例如一系列基本上正方形的成形凹坑。在至少一个此类实施例中,每个正方形的成形凹坑的成形表面可包括在正方形的侧面之间延伸的弓形表面。在一些实施例中,砧座可包括例如一系列圆形或球形凹坑。在各种实施例中,对上文进行进一步描述,成形凹坑10261可沿一个或多个行被定位,并且相似地,成形凹坑10262也可沿一个或多个行被定位。在各种其他实施例中,成形凹坑10261和/或成形凹坑10262可被布置成一个或多个圆形行。在至少一个此类实施例中,成形凹坑10261可沿主圆周被布置,并行成形凹坑10262可沿不同的圆周被布置。在各种实施例中,主圆周和不同的圆周可为同心的或基本上同心的。在某些实施例中,成形凹坑10262可例如沿内圆周和/或外圆周被布置;所述内圆周相对于主圆周径向向内定位,所述外圆周相对于主圆周径向向外定位。在各种实施例中,主圆周可由主直径限定,内圆周可由内直径限定,并且外圆周可由外直径限定。在至少一个此类实施例中,内直径可短于主直径,并且外直径可长于主直径。
在各种实施例中,如上所述,砧座例如可从打开位置运动到闭合位置,以便抵靠钉仓的组织厚度补偿件诸如组织厚度补偿件10020压紧组织。在各种情况下,在组织厚度补偿件相对于组织定位之前,组织厚度补偿件可邻近钉仓的支撑部分定位。在某些实施例中,组织厚度补偿件10020可处于如下位置:在该位置,在砧座运动到其闭合位置之前,组织厚度补偿件邻接支撑部分10018。在某些其他实施例中,组织厚度补偿件10020可处于如下位置:在该位置,间隙存在于组织厚度补偿件10020和支撑部分10018之间。至少一个此类实施例中,砧座可使组织和组织厚度补偿件10020向下位移,直到组织厚度补偿件10020邻接支撑部分10018,其中,砧座此时可运动到其闭合位置并且在组织内产生压缩。如果对砧座和钉仓之间的组织的定位感到不满意,则外科医生可打开砧座,调整砧座和钉仓的位置,并且再次闭合砧座。由于钉仓相对于组织的此类定位和重新定位,在各种情况下,组织厚度补偿件10020的远端可例如与支撑部分10010分离。在一些此类情况下,组织厚度补偿件10020的远端可接触组织,并从支撑部分10010剥离或相对于支撑部分10010卷起。在各种实施例中,如下文进一步所述,钉仓可包括能够将组织厚度补偿件可释放地保持到钉仓的下面的支撑部分的一个或多个结构。
在各种实施例中,现在参见图265,钉仓10300可包括支撑部分10310、由支撑部分10310支撑的组织厚度补偿件10320、以及包括鼻部10303的远端10302,该鼻部能够将组织厚度补偿件10320的远端10325可释放地保持就位。在至少一个实施例中,鼻部10303可包括能够容纳组织厚度补偿件10320的远端10325的狭槽10305。在各种实施例中,远端10325可被压缩或楔入在狭槽10305中,使得当钉仓10300相对于组织定位时,远端10325可被保持就位。在至少一个此类实施例中,狭槽10305可沿平行于或至少基本平行于支撑部分10310的平台表面10311的方向取向。在各种实施例中,狭槽10305可相对于平台表面10311为水平的。在各种其他实施例中,现在参见图266,钉仓10400可包括支撑部分、由支撑部分支撑的组织厚度补偿件10420、以及包括鼻部10403的远端10402,该鼻部能够将组织厚度补偿件10420的远端10425可释放地保持就位。在至少一个实施例中,远端10425可包括从其延伸的突出部,并且鼻部10403可包括能够容纳远端10425的突出部的竖直狭槽10405。在各种实施例中,远端10425和/或从其延伸的突出部可被压缩或楔入在狭槽10405中,使得当钉仓10400相对于组织定位时,远端10425可被保持就位。在某些实施例中,组织厚度补偿件10420例如可包括狭槽诸如狭槽10429,该狭槽能够在其中容纳鼻部10403的至少一部分。在至少一个实施例中,狭槽10405可沿垂直于或至少基本垂直于支撑部分的平台表面10411的方向取向。在各种实施例中,现在参见图267,钉仓10500可包括支撑部分、由支撑部分支撑的组织厚度补偿件10520、以及包括鼻部的远端10502,该鼻部能够将组织厚度补偿件10520的远端10525可释放地保持就位。在至少一个实施例中,鼻部可包括能够容纳组织厚度补偿件10520的远端10525的竖直狭槽10505。在各种实施例中,远端10525可被压缩或楔入在狭槽10505中,使得当钉仓10500相对于组织定位时,远端10525可被保持就位。
在各种实施例中,再次参见图265,组织厚度补偿件10320可包括顶部表面10324,该顶部表面可被定位在鼻部10303的顶部表面10304上方。图238示出了另一个示例性实施例,在该示例性实施例中,组织厚度补偿件的顶部表面被定位在钉仓的鼻部上方,其中组织厚度补偿件10720的顶部表面10721例如被定位在鼻部10003的顶部表面10004上方。在使用中,再次参见图265,组织可在鼻部10303的顶部表面10304之上滑动,并且在一些情况下,组织可接触组织厚度补偿件10320的远端10325,并且可将力施加到组织厚度补偿件10320,从而使组织厚度补偿件10320从支撑部分10310剥离。在本文所述的实施例中,该剥离力可被鼻部10303内楔入的远端10325的部分所抵抗。在任何情况下,一旦组织已相对于钉仓13000恰当定位,砧座可被旋转到闭合位置以抵靠支撑部分10310压缩组织和组织厚度补偿件10320。在至少一个此类实施例中,砧座可被旋转到如下位置:在该位置,砧座接触鼻部10303的顶部表面10304,因此可防止砧座进一步旋转。在各种情况下,由于组织厚度补偿件10320的顶部表面10324被定位在鼻部10303的顶部表面10304上方,当砧座正被闭合时,顶部表面10324可朝支撑部分10310被向下推动,并且在一些情况下,顶部表面10324例如可被推动到鼻部10303的顶部表面10304下方。如本文所述,当容纳在钉仓10300内的钉已被部署并且组织厚度补偿件10320已被切割后,支撑部分10310和鼻部10303可运动远离组织厚度补偿件10320,使得组织厚度补偿件10320的远端10325可滑出狭槽10305。
如上所述,砧座诸如砧座10060例如可被旋转到闭合位置,在该闭合位置,砧座10060接触钉仓诸如钉仓10000的顶部鼻部表面10004。一旦砧座已到达其闭合位置,则组织厚度补偿件诸如组织厚度补偿件10020被压缩的量除了别的之外将取决于组织厚度补偿件的未压缩厚度或高度以及组织的厚度。现在参见图236和图237,组织厚度补偿件10920可包括与鼻部10003的顶部表面10004齐平或至少基本齐平的顶部表面。在此类实施例中,组织厚度补偿件10920的顶部表面可被推动到鼻部10003的顶部表面10004下方。现在参见图241和图242,组织厚度补偿件诸如组织厚度补偿件10820例如可包括顶部表面10821。在组织厚度补偿件10820被组织T和砧座10060压缩之前,该顶部表面被定位在顶部鼻部表面10004下方。如图239和图240所示,在组织T相对较薄的情况下,组织厚度补偿件10920可能经受相对较小的压缩。现在参见图241和图242,当组织T相对较厚时,组织厚度补偿件10820可能经受较大的压缩。如图243和图244所示,在组织T同时具有薄层和较厚层的情况下,组织厚度补偿件10820可当其被定位在较厚组织T下面时被压缩较大量,并且当其被定位在较薄组织下面时被压缩较小的量。如上所述,以这种方式,组织厚度补偿件可补偿不同的组织厚度。
在各种实施例中,现在参见图268-270,外科缝合器械可包括1)能够容纳钉仓16600的仓通道16670,以及2)以能够枢转的方式联接至仓通道16670的砧座16660。钉仓16600可包括支撑部分16610和组织厚度补偿件16620,其中组织厚度补偿件16620的远端16625可由钉仓16600的远端16602处的鼻部16603可释放地保持到支撑部分16610。在至少一个实施例中,鼻部16603可包括狭槽16605并且可由柔性材料构成。在使用中,首先参见图269,鼻部16603可向下挠曲,以便扩大狭槽16605的开口。在某些实施例中,鼻部16603可包括凹口或切口16606,该凹口或切口能够使鼻部16603向下挠曲。在任何情况下,在各种情况下,狭槽16605的扩大的开口可有利于将组织厚度补偿件16620的远端16625插入狭槽16605中。一旦组织厚度补偿件16620已恰当定位,鼻部16603可被释放,并且由于组成鼻部16603的材料的回弹力,鼻部16603可返回或至少基本返回至其未挠曲状态,并在平台表面16611上捕获组织厚度补偿件16620的远端16625,如图270所示。在使用中,类似于上文所述,当支撑部分16610运动远离缝合的组织时,远端16625可被牵拉出狭槽16605。在各种情况下,当组织厚度补偿件16620与支撑部分16610分离时,柔性鼻部16603能够偏转。在各种实施例中,再次参见图270,组织厚度补偿件16620可包括与鼻部16603的顶部表面16604对齐或至少基本对齐的顶部表面16621。
在各种实施例中,参见图271,外科缝合器械可包括1)能够容纳钉仓10700的通道10770,以及2)可旋转地联接至通道10770的砧座10760。钉仓10700可包括支撑部分10710和组织厚度补偿件10720。在各种实施例中,组织厚度补偿件10720可由鼻部套10703保持就位,该鼻部套可在支撑部分10710之上滑动。在至少一个实施例中,首先参见图272,鼻部套10703可包括一个或多个侧狭槽10707,该一个或多个侧狭槽能够可移除地容纳例如沿支撑部分10710延伸的一个或多个附接件。在各种实施例中,组织厚度补偿件10720可被定位在侧狭槽10707中间。在某些实施例中,鼻部套10703还可包括远端10702和限定在远端10702中的腔体10706,其中腔体10706还能够在其中容纳例如支撑部分10710的至少一部分。在使用中,鼻部套10703可在支撑部分10710上从远侧至近侧的方向滑动。在各种实施例中,组织厚度补偿件10720可被可移除地安装至鼻部套10703,使得在钉已击发穿过组织厚度补偿件10720后,当支撑部分10710和鼻部套10703运动远离组织厚度补偿件10720时,组织厚度补偿件10720可与鼻部套10703分离。在各种实施例中,组织厚度补偿件10720的顶部表面10721可被定位在鼻部10703的顶部表面10704下方。
在各种实施例中,现在参见图273和图274,外科缝合器械可包括1)能够容纳钉仓11000的钉仓通道11070,以及2)可旋转地联接至通道11070的砧座11060。钉仓11000可包括支撑部分11010和组织厚度补偿件11020。在各种实施例中,组织厚度补偿件11020可由从支撑部分11010的平台11011延伸的一个或多个纵向导轨11019保持就位。在至少一个实施例中,纵向导轨11019可被嵌入在组织厚度补偿件11020中。在某些实施例中,首先参见图274,组织厚度补偿件11020可包括能够容纳纵向导轨11019的纵向凹槽11029。在至少一个此类实施例中,凹槽11029的尺寸可设定成并且能够容纳例如压配式构造的导轨11019。对上文进行进一步描述,此类结构能够防止或至少限制组织厚度补偿件11020和支撑部分11010之间相对的侧向运动,并且此外,限制组织厚度补偿件11020例如被过早地从支撑部分11010释放。在各种实施例中,现在参见图275,外科缝合器械可包括1)能够容纳钉仓11100的钉仓通道11170,以及2)可旋转地联接至通道11170的砧座11160。钉仓11100可包括支撑部分11110和组织厚度补偿件11120。在各种实施例中,组织厚度补偿件11120可由从支撑部分11110的平台11111延伸的长钉或齿状物11119的一个或多个纵向行保持就位。在至少一个实施例中,长钉的纵向行11119可被嵌入在组织厚度补偿件11120中。
参照图273所示的实施例。对上文进行进一步描述,当钉从限定在其中的钉腔10012被射出时,钉仓11000的组织厚度补偿件11020可从支撑部分11010被逐渐释放。更具体地,对上文进行进一步描述,定位在钉腔10012中的钉可在钉仓11000的近端11001和钉仓11000的远端11002之间被依次射出,使得当钉被射出时,钉将向上的偏置力施加到组织厚度补偿件11020,该偏置力作用以将组织厚度补偿件11020推离导轨11019。在此类情况下,当钉从最近侧钉腔10012被射出时,组织厚度补偿件11020的近端11006可从支撑部分11010被释放。当钉从钉仓11000的近端11001和远端11002之间的支撑部分11010被逐渐射出时,组织厚度补偿件11020随后可从支撑部分11010被逐渐释放。当定位在最远侧钉腔10012内的钉从支撑部分11010被射出时,组织厚度补偿件11020的远端11007可从支撑部分11010被释放。参照图275所示的实施例,当钉从尖端11101和远端11102之间的钉仓被逐渐射出时,组织厚度补偿件11120可从自支撑部分11110延伸的长钉1119被逐渐释放。
如上所述,当钉从支撑部分被逐渐射出并接触组织厚度补偿件时,组织厚度补偿件可从钉仓的支撑部分被逐渐释放。在各种实施例中,例如在没有将组织厚度补偿件从支撑部分释放的情况下,钉的腿诸如钉腿10032能够穿过组织厚度补偿件。在此类实施例中,组织厚度补偿件可保持与支撑部分接合,直到钉的基部诸如基部10031接触组织厚度补偿件并将其向上推动。然而在各种实施例中,夹板和/或从支撑部分延伸的其他保持结构例如可阻碍组织厚度补偿件从支撑部分的释放。在某些实施例中,如下文更详细所述,支撑部分可包括保持结构,当钉从钉仓被逐渐击发时,该保持结构能够逐渐将组织厚度补偿件从支撑部分释放。现在参见图283,钉仓诸如钉仓11200例如可包括支撑部分11210,该支撑部分包括能够将组织厚度补偿件11220(图284)可释放地保持到支撑部分11210的保持结构11213。在各种实施例中,保持结构11213可被定位在例如每个钉腔11212的端部处,其中每个保持结构11213可包括限定在其中的导向沟槽11216,该导向沟槽能够可滑动地容纳钉10030的钉腿10032。在此类实施例中,钉腿10032和保持结构11213能够将组织厚度补偿件11220可释放地保持到支撑部分11210。在使用中,现在参见图284,容纳在支撑部分11210内的钉驱动器10040可由滑动件10050向上驱动,如上所述,其中钉驱动器10040能够接触保持结构11213,使保持结构11213与支撑部分11210至少部分地分离,并且使保持结构11213向外并远离钉10030和钉腔11212位移。当保持结构11213与支撑部分11210分离和/或向外位移时,如图284所示,保持结构11213可不再能够将组织厚度补偿件11220保持到支撑部分11210,因此,组织厚度补偿件11220可从支撑部分11210被释放。类似于上文所述,当钉10030例如从钉仓朝砧座诸如砧座11260被逐渐射出时,组织厚度补偿件11220可从支撑部分11210被逐渐释放。在各种实施例中,当钉驱动器10040的顶部表面例如与支撑部分11210的平台表面11211共平面或至少基本上共平面时,钉驱动器10040可接触保持结构11213。在此类实施例中,在钉10030被形成为其完全成形或完全击发构型的同时和/或在钉10030被形成为其完全成形或完全击发构型之前,组织厚度补偿件11220可从支撑部分11210释放。在至少一个此类实施例中,首先参见图285,驱动器10040可被过度驱动,使得其被推动到平台表面11211上方以使钉10030完全成形,并且在被过度驱动的过程期间,使保持结构11213与支撑部分11210脱离。在各种实施例中,再次参见图284,保持结构11213在分离或向外位移之前可延伸到或悬垂到钉腔11212之上并进入到钉腔中,使得刚好当驱动器10040到达平台表面11211时,驱动器10040可接触保持结构11213。在任何情况下,一旦组织厚度补偿件11220已从支撑部分11210被释放,现在参见图285,则支撑部分11210可运动远离植入的组织厚度补偿件11220。
如上所述,当钉从钉仓被击发或部署时,钉仓的可压缩的组织厚度补偿件可从钉仓的支撑部分或仓体被逐渐释放。在各种情况下,此类释放可包括使组织厚度补偿件从支撑部分逐渐松开,其中在一些情况下,直到砧座被打开并且支撑部分运动远离植入的组织厚度补偿件,组织厚度补偿件才可能与支撑部分完全分离。在各种实施例中,现在参见图289,钉仓诸如钉仓11300例如可包括可释放地保持到支撑部分11310的组织厚度补偿件11320。在至少一个实施例中,支撑部分11310可包括从其延伸的多个保持构件11313,该多个保持构件能够将组织厚度补偿件11320可释放地压缩并保持到支撑部分11310。在至少一个此类实施例中,每个保持构件11313可包括能够在其中容纳组织厚度补偿件11320的纵向侧的面向内的通道或狭槽11316。在各种情况下,多个保持构件11313可沿支撑部分11310的第一纵向侧延伸,并且多个保持构件11313可沿支撑部分11310的第二纵向侧延伸。其中,在某些情况下,保持构件11313能够防止或至少限制组织厚度补偿件11320和支撑部分11310之间相对的侧向运动,并且此外防止或至少限制组织厚度补偿件11320过早地从支撑部分11310释放。在各种实施例中,保持构件11313可与支撑部分11310一体成型,并且在至少一个实施例中,参见图290,保持构件11313能够与支撑部分11310分离或至少部分分离,以便使组织厚度补偿件11320与支撑部分11310分离,例如如图291所示。在某些实施例中,砧座诸如砧座11360例如能够压缩组织厚度补偿件11320,并且响应于组织厚度补偿件11320中产生的压力,组织厚度补偿件11320可侧向伸展至使保持构件11313与组织厚度补偿件11320至少部分地分离或脱离。在各种实施例中,如上所述,推进刀构件穿过砧座11360和钉仓11300可部署被容纳在其中的钉,并且同时挤压砧座11360和钉仓11300使其更靠近彼此,这可将增加的压缩力施加到组织厚度补偿件11320,从而当刀构件穿过钉仓11300时使保持构件11313依次分离。
在各种实施例中,现在参见图292-294,钉仓诸如钉仓11400例如可包括可移除地附接到支撑部分11410的组织厚度补偿件11420。在至少一个实施例中,钉仓11400可包括能够将组织厚度补偿件11420的纵向侧保持到平台表面11411的一个或多个保持器杆11413。在至少一个此类实施例中,每个保持器杆11413可包括相对臂11418,该相对臂限定其间的通道11416。在此类实施例中,臂11418中的一个能够延伸到组织厚度补偿件11420之上,并且另一个臂11418能够延伸到从支撑部分11410延伸的唇缘11419下面。首先参见图292,每个保持器杆11413的通道11416的尺寸可设定成并且能够在使用钉仓11400前将压缩力施加到组织厚度补偿件11420的纵向侧。在使用期间,首先参见图293,钉仓11400可被定位在钉仓通道内,并且一旦钉仓11400已恰当定位,砧座诸如砧座11460例如可运动到其可压缩组织厚度补偿件11420的位置中。类似于上文所述,当被压缩时,组织厚度补偿件11420可侧向或向外伸展,并因此使保持器杆11413与钉仓11400分离。在某些其他实施例中,砧座11460的闭合可使保持器杆11413不与钉仓分离或不与钉仓完全分离。在至少一个此类实施例中,如上所述,推进击发杆穿过钉仓11400可从支撑部分11410部署钉10030,并且同时挤压砧座11460和钉仓11400使其更靠近彼此,以便将压缩力施加到组织厚度补偿件11420,该压缩力足以使组织厚度补偿件11420侧向伸展,并且使保持器杆11413与钉仓11400分离。一旦保持器杆11413已与钉仓11400分离,参见图294,支撑部分11410可运动远离植入的组织厚度补偿件11420并从手术部位移除。在某些可供选择的实施例中,现在参见图295,钉仓11400’可包括保持器杆11413’,该保持器杆类似于上文所述可包括从其延伸的臂11418’。在至少一个此类实施例中,臂11418’中的每一个可包括能够将保持器杆11413’可释放地闩锁到钉仓11400’的楔-锁斜面11417’。更具体地,在至少一个实施例中,钉仓11400’的支撑部分11410’可包括底切11419’,该底切与楔-锁斜面11417’协作,能够将保持器杆11413’可释放地保持到钉仓11400,并抑制组织厚度补偿件11420过早地与支撑部分11410’分离。在使用其间,类似于上文所述,当足够的压缩力被施加到组织厚度补偿件11420时,保持器杆11413’可与钉仓11400’分离。
在各种情况下,如上所述并再次参见图259和图260,钉仓10000的滑动件10050和外科缝合器械的击发构件10052可从钉仓10000的近端10001运动到钉仓10000的远端10002(图219),以便从支撑部分10010部署钉10030。在至少一种此类情况下,每个钉10030可从未击发位置运动到击发位置,并从支撑部分10010射出以在定位于砧座10060和钉仓10000之间的组织上捕获整个组织厚度补偿件10020。在某些情况下,外科医生可能不需要从钉仓10000中击发所有钉10030,并且外科医生可能使滑动件10050和击发杆10052的前进被阻挡于位于钉仓10000的近端10001和远端10002中间的点处。在此类情况下,组织厚度补偿件10020可仅被部分植入组织T内,以便使组织厚度补偿件10020的未植入部分与支撑部分10010分离。外科医生可将支撑部分10010远离部分植入的组织厚度补偿件10020牵拉,使得未植入部分从支撑部分10010剥离或脱落。尽管此类实施例适于各种情况,图300-302示出了改进,其中组织厚度补偿件诸如钉仓11500的组织厚度补偿件11520例如可包括能够彼此分离的多个连接片段。在至少一个此类实施例中,组织厚度补偿件11520可包括第一或最近侧片段11520a、可移除地连接至第一片段11520a的第二片段11520b、可移除地连接至第二片段11520b的第三片段11520c、可移除地连接至第三片段11520c的第四片段11520d和可移除地连接至第四片段11520d的第五片段11520e。在各种实施例中,组织厚度补偿件11520可包括定位在任意两个相邻片段11520a-11520e中间的能够限定预定的破裂点或分离点的至少一个薄层11529,组织厚度补偿件片段可在该破裂点或分离点彼此分离。在某些实施例中,组织厚度补偿件可包括任何合适的穿孔、薄层、和/或用于在组织厚度补偿件内产生分离点的任何其他装置。首先参见图301,砧座11560示为处于闭合位置,并且击发构件10052示为已被部分推进穿过钉仓11500,使得第一片段11520a、第二片段11520b和第三片段11520c下面的钉10030被击发以在组织T上捕获组织厚度补偿件11520。在该位置,击发构件10052还未被推进以部署例如第四片段11520d和第五片段11520e下面的钉10030。现在参见图302,砧座11560已运动到打开位置,并且钉仓11500的支撑部分11510已运动远离组织厚度补偿件11520的植入部分。如图302所示,位于第三片段11520c和第四片段11520d中间的薄层11529(图300)已使组织厚度补偿件11520的未植入部分与植入部分分离。
在各种实施例中,对上文进行进一步描述,钉仓可包括多个紧固件,该多个紧固件能够将组织厚度补偿件可释放地保持到钉仓的支撑部分。在某些实施例中,支撑部分可包括例如限定在平台表面中的多个孔,其中紧固件可延伸穿过组织厚度补偿件并且可被可释放地保持在支撑部分孔中。在使用中,当钉从支撑部分被逐渐射出时,紧固件可从支撑部分被逐渐释放。在至少一个此类实施例中,紧固件可随组织厚度补偿件一起被植入,并且在至少一个实施例中,紧固件可例如由至少一种可生物吸收的材料构成。在某些实施例中,在组织厚度补偿件已被至少部分植入之后,并且当支撑部分运动远离植入的组织厚度补偿件时,紧固件可与支撑部分分离。在各种实施例中,现在参见图323-325,钉仓诸如钉仓11600例如可包括通过多个紧固件11613被可释放地安装到支撑部分11610的组织厚度补偿件11620。每个紧固件11613可包括嵌入组织厚度补偿件11620内和/或与组织厚度补偿件11620接合的第一端部11618、与支撑部分11610接合的第二端部11618、以及将第一端部11618连接至第二端部11618的连接器11616。在各中实施例中,紧固件11613可延伸穿过限定在支撑部分11610中的刀狭槽11615。在使用中,如上所述,击发构件10052可使刀刃运动穿过支撑部分11610中的刀狭槽11615并且切割紧固件11613,以便从支撑部分11610释放组织厚度补偿件11620。在至少一个此类实施例中,击发杆10052可从钉仓11600的近端11601被推进到钉仓11600的远端11602,以便1)如上所述将滑动件10050朝远侧推进并逐渐击发钉10030,并且2)逐渐切割紧固件11613和/或使紧固件11613断裂以从支撑部分11610逐渐释放组织厚度补偿件11620。在某些实施例中,类似于上文所述,组织厚度补偿件11620可包括多个可分离片段11620a-11620e,该多个可分离片段例如可各自通过一个或多个紧固件11613保持到支撑部分11610。如图324所示,如果击发构件10052被阻挡于钉仓11600的近端11601和远端11602中间,在砧座11660被打开并且支撑部分11610运动远离组织T之后,如图325所示,紧固件11613可有助于将组织厚度补偿件11620的未植入部分保持到支撑部分11610。在各种实施例中,对上文进行进一步描述,击发构件10052的切刃10053能够切割紧固件11613和/或使紧固件11613断裂。在某些可供选择的实施例中,现在参见图327和图328,钉部署滑动件诸如滑动件11650例如可包括刀刃11653,当滑动件11650横贯钉仓11600时,该刀刃能够切割紧固件11613的连接器11616。在至少一个此类实施例中,每个连接器11616可包括在紧固件11613的T形端部11618之间延伸的圆柱形构件,其中刀刃11653可包括内弧形面11653,该内弧形面例如能够容纳圆柱形连接器11616。
如上所述,钉仓可被装载到外科缝合器械的钉仓通道内。在各种情况下,外科医生或其他临床医生可通过将向下的力施加到钉仓上而将钉仓插入钉仓通道中以将钉仓锁定就位。在某些此类情况下,临床医生可例如将其拇指放置在钉仓的顶部表面上来施加此类向下的力。在各种实施例中,钉仓的顶部表面可包括组织厚度补偿件的顶部表面,其中,如上所述,组织厚度补偿件可为可压缩的,并且在某些实施例中,施加到组织厚度补偿件的向下的力可使组织厚度补偿件压缩到如下的点:在该点,临床医生的拇指与储存在支撑部分中的钉的末端接触。在各种实施例中,可利用钉仓施用装置将钉仓插入钉仓通道中,该钉仓施用装置能够防止或至少限制临床医生触碰到钉仓中的钉的可能性。在钉仓已被正确定位在钉仓通道中之后,如下文更详细所述,施用装置可与钉仓分离。
在某些实施例中,现在参见图305和图306,钉仓施用装置可例如包括可附接到钉仓10000的刚性盖诸如盖10080。对上文进行进一步描述,当钉仓10000被插入钉仓通道中时,盖10080能够例如防止或至少抑制临床医生的拇指接触定位在钉仓10000内的钉10030的末端。现在参见图307和图308,盖10080可延伸到组织厚度补偿件10020的顶部表面10021或顶部表面10021的至少一部分之上,并且可包括1)可延伸到组织厚度补偿件10020之上和/或邻接组织厚度补偿件10020的底部表面10081,以及2)可为临床医生提供按压表面以向其施加向下的力的顶部表面10082。在使用中,临床医生可抓握盖10080的柄部部分10084,将钉仓10000的支撑部分10010与钉仓通道对齐,并至少部分地将钉仓10000插入钉仓通道内。然后,临床医生可通过向盖10880的顶部表面10082施加向下的力来使钉仓10000完全坐置在钉仓通道中。在各种实施例中,该向下的力可被直接传递到支撑部分10010。在至少一个此类实施例中,盖10080可包括近侧支撑件10087,该支撑件可向下延伸并接触支撑部分的平台表面10011。在某些实施例中,盖10080还可包括能够邻接鼻部10003的远侧支撑部分10083。当向盖10080施加向下的力时,该向下的力可通过近侧支撑件10087和/或远侧支撑部分10083被传递,而不会或至少基本上不会将该向下的力通过组织厚度补偿件10020传递到支撑部分10010。在各种情况下,由于上文所述,临床医生可不直接接触组织厚度补偿件10020。还由于上文所述,当钉仓10000被插入钉仓通道中时,盖10080可不压缩或至少基本上不压缩组织厚度补偿件10020。在各种实施例中,盖可包括任何合适数量的支撑件,该支撑件能够将向下的力传递到支撑部分,而不会或至少基本上不会通过组织厚度补偿件传递该向下的力。在某些实施例中,支撑件可延伸到组织厚度补偿件的近端、远端、和/或纵向侧的周围。在某些实施例中,支撑件可延伸穿过组织厚度补偿件。在至少一个此类实施例中,支撑件可延伸穿过组织厚度补偿件中的孔并邻接支撑部分的平台。在某些实施例中,至少一些支撑件可以在向下的力施加到盖之前不接触平台;然而,在各种实施例中,盖能够挠曲,或向下运动直到支撑件接触支撑部分的平台。此时,可阻止或至少基本上阻止盖的向下的挠曲或运动进一步挠曲。
如上所述,盖10080可附接到钉仓10000并可用于调控钉仓10000的位置。在各种实施例中,盖10080可包括任何合适数量的夹持构件,该夹持构件例如能够将盖10080可释放地保持到钉仓10000的支撑部分10010。在至少一个此类实施例中,盖10080例如还可包括一个或多个保持构件,诸如锁臂10088和/或10089。在各种实施例中,锁臂10089能够延伸到鼻部10003的侧面周围并接合鼻部10003的底部表面10009(图306)。相似地,锁臂10088可延伸到锁突出部10008的侧面周围,该锁突出部从支撑部分10010延伸并接合锁突出部10008的底部表面。在各种实施例中,这些锁臂能够将盖10080定位在如下区或区域之上:在该区或区域中,钉被储存在支撑部分10010中。在任何情况下,一旦钉仓10000已被正确定位,盖10080可与钉仓10000分离。在至少一个实施例中,临床医生可向柄部10084施加向上的提升力,以便将盖10080的远端与钉仓10000的远端10002分离。在至少一个此类实施例中,在柄部10084被向上抬起时,锁臂10088和10089可向外挠曲,使得锁臂10088和10089可分别围绕锁突出部10008和鼻部10003挠曲。然后,盖10080的近端可被提离钉仓的近端10001,并且盖10080可运动远离钉仓10000。
在某些实施例中,现在参见图309和图310,除了将钉仓诸如钉仓10600例如定位在钉仓通道内之外,钉仓施用装置诸如钉仓施用装置10680例如还能够将上部组织厚度补偿件诸如组织厚度补偿件10690例如相对于砧座定位。类似于上文所述,施用装置10680可包括能够与锁突出部10608可释放地接合的锁臂10688,该锁突出部从钉仓10600的支撑部分10610延伸,使得施用装置可被保持在钉仓10600的组织厚度补偿件10620之上的位置处。在各种实施例中,上部组织厚度补偿件10690能够可移除地附接到钉仓施用装置10680,使得外科器械的砧座诸如砧座10060例如可在施用装置10680上闭合,接合组织厚度补偿件10690,并使组织厚度补偿件10690与施用装置10680分离。在各种实施例中,组织厚度补偿件10690和/或砧座10060可包括一个或多个保持结构,该保持结构能够将组织厚度补偿件10690可释放地保持到砧座10060。在至少一个此类实施例中,组织厚度补偿件10690可包括例如从组织厚度补偿件10690的顶部表面10691延伸的纵向导轨10695,该纵向导轨可被容纳于限定在砧座10060内的纵向刀狭槽10065中。在各种实施例中,组织厚度补偿件10690和纵向导轨10695可例如由任何合适的可压缩材料构成,诸如描述于该专利申请中的那些,其中纵向导轨10695例如可被压缩和/或楔入在刀狭槽10065内。一旦砧座10060已与组织厚度补偿件10690接合,则砧座10060可返回到打开位置,并且在此类情况下,组织厚度补偿件10690可与施用装置10680分离。然后,施用装置10680可与钉仓10600分离,使得砧座10060和钉仓10600可相对于将被缝合和/或切割的组织定位。在使用中,钉部署滑动件诸如滑动件10050(图236)例如可由击发构件10052(图236)朝远侧推进穿过钉仓10600,例如以便将钉从钉仓10060射出,如上所述。由于钉变形,因此每个钉可在组织的顶部表面捕获组织厚度补偿件10690的一部分,并且在组织的底部表面捕获组织厚度补偿件10620的一部分。同时,击发构件10052可推进刀刃10053(图236)穿过组织厚度补偿件10620和/或组织厚度补偿件10690。其中在至少一个实施例中,刀刃10053可通过纵向导轨10695被推进,以便切割导轨10695并且使组织厚度补偿件10690与砧座10060逐渐分离。在钉已被部署之后,砧座10060可被再次打开并运动远离植入的组织厚度补偿件10690,并且类似地,钉仓10600的支撑部分10610可运动远离植入的组织厚度补偿件10620。在各种实施例中,对上文进行进一步描述,组织厚度补偿件10620和/或组织厚度补偿件10690可包括多个可分离片段。如果仅组织厚度补偿件10620和10690的部分被通过钉植入时,可分离片段能够彼此分离。
在各种实施例中,对上文进行进一步描述,施用装置10680可包括能够将组织厚度补偿件10690可释放地保持到施用装置10680的一个或多个保持结构。在至少一个此类实施例中,首先参见图310,施用装置10680可包括能够被容纳在纵向保持狭槽10694中的纵向保持导轨10685,该纵向保持狭槽以压配方式被限定在组织厚度补偿件10690的底部表面10692中。在各种情况下,保持导轨10685和保持狭槽10694能够将组织厚度补偿件10690保持到施用装置10680,直到通过砧座10060向组织厚度补偿件10690施加足够的向上的提升力,如上所述。在至少一个此类实施例中,从施用装置10680延伸的保持导轨10685还可包括定位在保持导轨10685的近端和远端处的端部止挡件10686,该端部止挡件能够防止或至少限制组织厚度补偿件10690和施用装置10680之间的相对纵向运动。在某些实施例中,再次参见图310,一种或多种粘合剂诸如纵向粘合带10693例如可被置于组织厚度补偿件10690的接触表面10691上,使得当砧座10060接触组织厚度补偿件10690时,如上所述,粘合剂能够将组织厚度补偿件10690可释放地附接到砧座10060。在各种实施例中,除了上述可压缩的保持结构外或代替上述可压缩的保持结构,例如可使用一种或多种粘合剂。在某些实施例中,可使用一种或多种粘合剂将组织厚度补偿件可释放地保持到钉仓施用装置。在至少一个实施例中,现在参见图310A,盖10080例如可包括一个或多个粘结垫12185,该一个或多个粘结垫能够将上部组织厚度补偿件诸如组织厚度补偿件12190例如可释放地保持到盖10080的顶部表面10082。在至少一个此类实施例中,类似于上述实施例,砧座可在组织厚度补偿件12190上被闭合以接合组织厚度补偿件12190的纵向保持导轨12195。在某些实施例中,释放机构可被定位在组织厚度补偿件12190和盖10080中间。该释放机构可用于打破将组织厚度补偿件12190保持到盖10080的粘结,并且使组织厚度补偿件12190与盖10080分离。在至少一个实施例中,释放机构可包括拉舌12196和套环12197,其中套环12197可包括附接到拉舌12196的第一端部和第二端部。套环12197可例如包括缝合线,该缝合线可限定界定粘结垫12185的周边,使得当拉舌12196朝远侧被牵拉时,缝合线可在组织厚度补偿件12190和盖10080之间滑动并接触组织垫12185。在此类情况下,缝合线例如可完成以下功能中的至少一种:使粘结垫12185与组织厚度补偿件12190分离;使粘结垫12185与盖10080分离;和/或切断粘结垫12185。
在各种实施例中,现在参见图311,钉仓可例如包括支撑部分10710。类似于上文所述,该支撑部分可包括贯穿延伸的纵向刀狭槽10715。在至少一个此类实施例中,钉仓施用装置诸如施用装置10780例如可包括纵向保持和对齐构件10786,该纵向保持和对齐构件延伸到支撑部分10710中的刀狭槽10715内。在某些实施例中,保持构件10786例如能够以压配方式接合刀狭槽10715的侧壁,使得施用装置10780能够被可释放地保持到支撑部分10710。在各种实施例中,尽管未示出,组织厚度补偿件的第一部分可被定位在保持构件10786的第一侧上,并且组织厚度补偿件的第二部分可被定位在保持构件10786的相对的或第二侧上。类似于上文所述,组织厚度补偿件的第一部分和第二部分例如可通过保持构件10013被安装到钉仓的支撑部分10710。还类似于上文所述,上部组织厚度补偿件10790能够通过从施用装置10780的装载表面10782延伸的纵向保持构件10785而被可移除地安装到施用装置10780。其中保持构件10785例如能够被可释放地压配到限定在组织厚度补偿件10790的底部表面10792中的纵向狭槽10794内。在各种实施例中,还类似于上文所述,组织厚度补偿件10790还可包括从组织厚度补偿件10790的顶部表面10791延伸的纵向保持构件10795,该纵向保持构件能够被可释放地保持在限定于砧座10060内的纵向刀狭槽10065中。在至少一个此类实施例中,纵向保持构件10795可包括楔形横截面,该楔形横截面包括大于底部的顶部,其中底部例如可将保持构件10795附接到组织厚度补偿件10790。
在各种实施例中,现在参见图312和图313,包括支撑部分10810和组织厚度补偿件10820的钉仓10800例如可随钉仓施用装置10880被装载到钉仓通道中。类似于上文所述,钉仓施用装置10880例如还能够将上部组织厚度补偿件10890相对于砧座诸如砧座10060定位,使得当砧座10060闭合时,砧座10060可接触并接合组织厚度补偿件10890。在至少一个实施例中,组织厚度补偿件10890可包括从组织厚度补偿件10890的顶部表面10891延伸的多个保持腿10895,该保持腿能够接合砧座10060并将组织厚度补偿件10890可释放地保持到砧座10060。在至少一个此类实施例中,腿10895可被布置成纵向排,其中每个腿10895可包括至少一个脚,该脚能够进入并接合被限定在砧座10060中的刀狭槽10065。在某些实施例中,腿10895的一些脚可沿一个方向延伸,而其他脚可沿另一个方向延伸。在至少一个实施例中,一些脚可沿相对的方向延伸。在任何情况下,一旦砧座10060已与组织厚度补偿件10890接合,现在参见图313和图314,砧座10060可被再次打开,并且临床医生可将钉仓施用装置10880移离组织厚度补偿件10820和10890。然后,参见图314A,上部组织厚度补偿件10890可被定位在靶组织的第一侧,并且可包括下部组织厚度补偿件的组织厚度补偿件10820可被定位在组织的第二侧上。当组织厚度补偿件10820和10890已被正确定位后,现在参见图314B,击发构件的刀刃诸如刀刃10053例如可被推进穿过组织和组织厚度补偿件。在各种实施例中,现在参见图318,钉仓施用装置诸如施用装置12280例如可包括可分离地安装到其的组织厚度补偿件12290。如图319所示,当砧座10060运动到闭合位置时,该组织厚度补偿件可类似于上文所述被插入钉仓通道中并由砧座10060接合。在至少一个此类实施例中,组织厚度补偿件12290可包括从组织厚度补偿件12290的顶部表面12291向上延伸的多个保持构件12295。其中每个保持构件12295可包括多个柔性腿12296,该多个柔性腿能够插入砧座10060中的刀狭槽10065内。首先参见图321和图322,每个保持构件12295的柔性腿12296可被间隙12298分开,使得当腿12296插入刀狭槽10065中时,腿12296可向内挠曲,并且一旦柔性腿12296的扩大的脚已穿过刀狭槽10065,则腿12296随后向外回弹。在各种实施例中,柔性腿12296的扩大的脚可在被限定于砧座10060中的相对的保持唇缘12297后面挠曲,并且由于腿12296和唇缘12297的相互作用,组织厚度补偿件12290可被保持到砧座10060。然后,钉仓施用装置12280可运动远离组织厚度补偿件12290,如图320所示。在使用中,一旦组织厚度补偿件12290例如已通过从钉仓10000部署的钉植入到组织上,则砧座10060可被再次打开,并且当砧座10060运动远离植入的组织厚度补偿件12290,保持构件12995的腿12296可向内挠曲,使得其可从刀狭槽10065被牵拉出。
在各种实施例中,现在参见图315和图316,组织厚度补偿件诸如组织厚度补偿件11990例如可被纵向装载到砧座诸如砧座11960中。更具体地,在至少一个实施例中,组织厚度补偿件11990可包括一个或多个纵向导轨11995,该一个或多个纵向导轨可插入砧座11960的刀狭槽11965中的远侧开口内,并随后朝远侧推动,直到组织厚度补偿件11990已恰当地坐置在砧座11960中。在至少一个此类实施例中,每个导轨11995可包括可被定位在纵向保持唇缘11997后面的纵向保持脚11996,该纵向保持唇缘例如至少部分限定刀狭槽11965。如图316所示,脚11996可沿相对的方向延伸,以便被定位在保持唇缘11997的后面,该保持唇缘被定位在刀狭槽11965的相对侧上。在各种实施例中,纵向间隙11998可被限定在导轨11995之间,当组织厚度补偿件11990与砧座11960分离时,该纵向间隙能够使导轨11995朝向彼此向内挠曲。在某些实施例中,现在参见图317,组织厚度补偿件诸如组织厚度补偿件12090例如可包括延伸到砧座诸如砧座12060的侧面周围的一个或多个锁臂12098。在使用中,锁臂12098可接合砧座12060并将组织厚度补偿件12090可释放地保持到砧座12060。在至少一个此类实施例中,砧座12060例如可包括一个或多个凹口或锁肩12097,该一个或多个凹口或锁肩各自能够容纳从锁臂12098延伸的脚。在使用中,当组织厚度补偿件12090至少被部分植入之后,在臂12098可向外挠曲,并且当砧座12060运动远离组织厚度补偿件12090时与砧座12060分离。
如上所述,外科缝合器械可包括能够容纳钉仓的钉仓通道、可旋转地联接到钉仓通道的砧座、和包括刀刃的击发构件,该击发构件可相对于砧座和钉仓通道运动。在使用中,钉仓可被定位在钉仓通道内,并且当钉仓被至少部分地消耗后,钉仓可从钉仓通道移除并被新的钉仓替换。在一些此类实施例中,外科缝合器械的钉仓通道、砧座、和/或击发构件可与替换钉仓一起被重复使用。在某些其他实施例中,钉仓可包括部分一次性加载单元组件,该一次性加载单元组件例如可包括钉仓通道、砧座、和/或击发构件,这些可随钉仓一起被替换,作为替换一次性加载单元组件的一部分。某些一次性加载单元组件公开于2008年2月15日提交的名称为“END EFECTOR COUPLING ARRANGMENTS FOR A SURGICALCUTTING AND STAPLING INSTRUMENT”的美国专利申请序列号12/031,817中,该专利申请的全部公开内容以引用方式并入本文。现在参见图370,一次性加载单元诸如一次性加载单元12500例如可包括支撑部分12510、可旋转地联接到支撑部分12510的砧座12560、以及从支撑部分12510延伸的细长轴12570。类似于本文所述的钉仓,支撑部分12510可包括多个钉腔10012和钉,例如定位在每个钉腔10012中的钉10030。一次性加载单元12500还可包括击发构件12552,该击发构件可朝远侧被推进以便将砧座12560从打开位置运动到闭合位置,如图370所示。在各种实施例中,一次性加载单元12500还可包括定位在支撑部分12510上和/或附接到支撑部分12510的组织厚度补偿件12520。其中,当砧座12560处于其闭合位置时,砧座12560可被定位在组织厚度补偿件12520的对面,并且在一些实施例中,当砧座12560处于其闭合位置时,砧座12560可至少部分地压缩组织厚度补偿件12520。在任一种情况下,击发构件12552可被进一步推进,以便将钉从支撑部分12510射出。当钉被射出后,钉可通过砧座12560变形,并捕获其中的组织厚度补偿件12520的至少一部分。然后,击发构件12552可朝近侧回缩,砧座12560可被再次打开,并且支撑部分12510可运动远离植入的组织厚度补偿件12520。
在各种实施例中,对上文进行进一步描述组织厚度补偿件12520可被可分离地安装到支撑部分12510。在至少一个此类实施例中,支撑部分12510可包括安装到其每个侧的纵向保持导轨12526,其中每个导轨12526可包括一个或多个孔12528,该一个或多个孔能够在其中容纳组织厚度补偿件12520的至少一部分。一旦组织厚度补偿件12520已至少被部分植入,则在支撑部分12510被移离时可将组织厚度补偿件12520从孔12528中牵拉出。各种实施例中,现在参见图371-373,一次性加载单元12600可包括支撑部分12610、可分离地安装到支撑部分12610的组织厚度补偿件12620、和一个或多个保持导轨12626,该一个或多个保持导轨能够延伸到组织厚度补偿件12620下面,并且将组织厚度补偿件12620安装到支撑部分12610。每个保持导轨12626例如可包括多个保持钩12628,该多个保持钩可通过例如限定在支撑部分12610中的保持狭槽12614接合到支撑部分12610。在使用中,在至少一个此类实施例中,当组织厚度补偿件12620至少被部分植入并且支撑部分12610运动远离组织厚度补偿件12620之后,组织厚度补偿件12620能够与保持导轨12626分离。在各种实施例中,现在参见图374-376,一次性加载单元12700可包括一个或多个保持导轨12726,该一个或多个保持导轨可各自包括可延伸到组织厚度补偿件12720下面的底杆12725、以及延伸到组织厚度补偿件12620的顶部表面12621之上的顶杆12727。在某些实施例中,组织厚度补偿件12620可在顶杆12727和底杆12725之间至少被部分压缩,使得保持导轨12726可相对于支撑部分12610保持组织厚度补偿件12620。在至少一个此类实施例中,每个保持导轨12726可包括一个或多个保持钩12728,该一个或多个保持钩可与支撑部分12610接合以将保持导轨12726保持到支撑部分12610。
在各种实施例中,现在参见图377和图378,一次性加载单元12800可包括保持构件12822,该保持构件能够将组织厚度补偿件12620安装到支撑部分12610。在至少一个此类实施例中,保持构件12822可包括定位在支撑部分的平台表面12611上的材料片,其中组织厚度补偿件12620例如可通过至少一种粘合剂附接到材料片。保持构件12822还可包括纵向保持导轨12825,该纵向保持导轨能够向下延伸到限定在支撑部分12610中的刀狭槽12615内。在至少一个此类实施例中,保持导轨12825的尺寸可设定成并且被配置成使得其在刀狭槽12615的侧壁之间被压缩。在使用中,击发构件12552可包括刀刃,在击发构件12552朝远侧被推进并纵向横切组织厚度补偿件12620和保持导轨12825时,该刀刃可穿过刀狭槽12615。另外,在使用中,从支撑部分12610射出的钉可穿透保持构件12822、组织厚度补偿件12820、以及定位在组织厚度补偿件12820和砧座12560之间的组织。在各种实施例中,保持构件12822可由生物相容性和/或可生物吸收的材料构成。在某些实施例中,保持构件12822可由可充分压缩的材料构成,以包括组织厚度补偿件12620下面的组织厚度补偿件。在各种实施例中,现在参见图379-381,一次性加载单元12900可包括加载组件,该加载组件包括能够可移除地附接到支撑部分12610的底部12922、能够可移除地附接到砧座12560的顶部12990、以及连接底部12922和顶部12990的柔性接头12991。类似于上文所述,纵向保持导轨12825可从底部12922向下延伸到限定在支撑部分12610中的刀狭槽12615内,使得底部12922可被可释放地保持到支撑部分12610。相似地,纵向保持导轨12995可从顶部12990向上延伸到限定在砧座12560中的刀狭槽内,使得顶部12990可被可释放地保持到砧座12560。如图380和图381所示,组织厚度补偿件12620可被安装到加载组件的底部12922,其中,为了相对于支撑部分12610定位组织厚度补偿件12620,临床医生可使顶部12990和底部12922朝彼此挠曲,将加载组件定位在砧座12560和支撑部分12610之间,并且释放挠曲的加载组件,使得加载组件可抵靠砧座12560来弹性伸展和偏置顶部12990,并抵靠支撑部分12610来弹性伸展和偏置底部12922。在至少一个实施例中,现在参见图382-384,加载组件还可包括例如从其延伸的一个或多个锁钩诸如锁钩12994,该锁钩能够将顶部12990可释放地连接至砧座12560,和/或将底部12922可释放地连接至支撑部分12610。
在各种实施例中,现在参见图385,一次性加载单元15900例如可包括砧座15960和钉仓通道15970,其中钉仓通道15970可相对于砧座15960旋转。在至少一个此类实施例中,砧座15960可能不能够旋转。在某些实施例中,组织可被定位在砧座15960和钉仓通道15970之间,并且随后钉仓通道15970可朝组织旋转以抵靠砧座夹持组织。在至少一个此类实施例中,一次性加载单元15900还可包括能够接触组织的组织厚度补偿件15920。
如上所述并参见图332,钉仓诸如钉仓10000例如可包括支撑部分10010和组织厚度补偿件10020,其中多个钉10030可至少被部分储存在支撑部分10010中,并且当钉10030处于其未击发位置时可延伸到组织厚度补偿件10020中。在各种实施例中,当钉10030处于其未击发位置时,钉10030的末端不从组织厚度补偿件10020突起。当钉10030被钉驱动器10040从其未击发位置运动到其击发位置时,如上所述,钉10030的末端可穿过组织厚度补偿件10020和/或穿过上层或外皮10022。在某些可供选择的实施例中,当钉10030处于其未击发位置时,钉10030的末端可凸穿组织厚度补偿件10020的顶部表面和/或外皮10022。在任一种情况下,当钉10030在被部署之前向上延伸出支撑部分10010时,钉10030可相对于支撑部分倾斜和/或偏转,同样如上所述。在各种实施例中,现在参见图329,钉仓诸如钉仓13000例如可包括多个导向构件或保持器,该多个导向构件或保持器能够限制钉仓13000的支撑部分13010和定位在其中的钉的末端之间的相对运动。首先参见图330,钉仓13000可包括安装到支撑部分13010的组织厚度补偿件13020,以及此外附接到组织厚度补偿件13020的顶部表面13021的多个脱脂棉13022。在各种实施例中,每个脱脂棉13022可包括限定在其中的多个孔13029,该多个孔能够在其中可滑动地容纳和/或引导钉13030的腿13022。除了孔之外或代替孔,脱脂棉例如可包括任何合适的开口,诸如狭槽、导向装置、和/或沟槽,其能够可滑动地容纳和/或引导腿13022。在某些实施例中,如图330所示,当钉13030处于其未击发位置时,钉腿13032的末端可被定位在孔13029内。在至少一个此类实施例中,当钉处于其未击发位置时,钉腿13032的末端可突起到脱脂棉13022上方。在某些其他实施例中,当钉13030处于其未击发位置时,钉腿13032的末端可被定位在脱脂棉13022的紧下方,使得当钉13030被向上运动穿过组织厚度补偿件13020时,钉腿13032可进入脱脂棉13022的孔13029中并滑动穿过该孔。在任何情况下,当钉13030的腿13032被定位在脱脂棉内时,可限制钉腿13032的侧向和/或纵向运动,而当钉13030被部署时不阻止钉腿13032的向上运动。当钉13030被部署时,现在参见图331,钉腿13032可向上滑动穿过脱脂棉13022,以穿透组织T,接触定位在钉仓13030对面的砧座,并向下变形以捕获其中的组织T和组织厚度补偿件13030。
在各种实施例中,对上文进行进一步描述,脱脂棉13022例如可使用至少一种生物相容性和/或可生物吸收的粘合剂附接到组织厚度补偿件13020。在某些实施例中,脱脂棉13022和/或从每个脱脂棉延伸的保持构件可至少部分嵌入组织厚度补偿件13020中。在至少一个此类实施例中,组织厚度补偿件13020可包括限定在其中的能够至少部分容纳脱脂棉13022的凹坑。在某些实施例中,在模制制造过程中,组织厚度补偿件13020可被整体模制或在脱脂棉13022周围形成。在各种实施例中,脱脂棉13022可包括可彼此独立运动的离散的保持器。在至少一个实施例中,首先参见图330,每个脱脂棉13022可包括互锁和/或键合结构,该互锁和/或键合结构能够允许并一定程度上限制脱脂棉13022之间相对的侧向和纵向运动。在至少一个此类实施例中,每个脱脂棉13022例如可包括突出部13026和一个或多个凹槽13027,其中第一脱脂棉13022的突出部13026可被定位在相邻的第二脱脂棉和第三脱脂棉13022的凹槽13027内,和/或相对于相邻的第二脱脂棉和第三脱脂棉13022的凹槽13027对齐。在各种实施例中,间隙可存在于相邻的脱脂棉13022之间,该间隙可使脱脂棉13022相对于彼此运动或滑动,直到其接触相邻的脱脂棉13022。在某些实施例中,脱脂棉13022可松散地互连。在各种实施例中,脱脂棉13022能够可分离地连接至彼此。在至少一个此类实施例中,脱脂棉13022可被制造为一片互连的脱脂棉。其中,当向该片施加足够的力时,脱脂棉13022中的一个或多个可与其他脱脂棉脱离。在某些实施例中,再次参见图329,第一片13024脱脂棉13022可被定位在纵向狭槽13025的第一侧上,并且第二片13024脱脂棉13022可被定位在狭槽13025的第二侧上。在至少一个实施例中,对上文进行进一步描述,延伸穿过组织厚度补偿件13020的纵向狭槽13025能够有利于击发构件的刀刃穿过组织厚度补偿件13020,并且当击发构件经过时,击发构件可向所述片13024施加压缩力,并且使脱脂棉13022中的至少一些分开或分离。
在各种实施例中,脱脂棉13022例如可由生物相容性和/或可生物吸收的塑料构成。在某些实施例中,脱脂棉13022例如可由实心材料、半实心材料、和/或柔性材料构成。在某些实施例中,脱脂棉13022可嵌入组织厚度补偿件内,使得脱脂棉13022随组织厚度补偿件运动。在至少一个此类实施例中,脱脂棉13022可为足够柔性的,使得其可随组织厚度补偿件的顶部表面挠曲。在某些实施例中,脱脂棉13022能够保持被嵌入到组织厚度补偿件中,而在某些其他实施例中,脱脂棉13022能够从组织厚度补偿件弹出或与组织厚度补偿件分离。在各种实施例中,脱脂棉13022可包括与组织厚度补偿件的顶部表面齐平的顶部表面。在某些实施例中,脱脂棉13022的顶部表面可被定位在组织厚度补偿件的顶部表面上方和/或下方。在各种实施例中,脱脂棉13022的顶部表面可被定位成使得当从组织厚度补偿件的顶部表面观察时其为可见的,而在其他实施例中,脱脂棉13022的顶部表面例如可被定位在组织厚度补偿件的层的下方。在某些实施例中,导向结构例如可被模制到组织厚度补偿件的顶部表面中。在至少一个此类实施例中,组织厚度补偿件可不包括复合材料,并且例如可包括一块整体的材料。
在各种实施例中,现在参见图338,钉仓例如可包括组织厚度补偿件13620以及外皮或顶层13621。在至少一个此类实施例中,一个或多个脱脂棉或保持器13622例如可嵌入外皮13621。在某些实施例中,每个保持器13622可包括其中限定的一个或多个孔13629,当钉13030处于其未击发位置时,该一个或多个孔能够在其中容纳钉13030的钉腿13032,如图338所示。在使用中,对上文进行进一步描述,当钉13030从其未击发位置运动到其击发位置时,钉腿10032可滑动穿过孔13629,直到钉13030的基部13031接触组织厚度补偿件13620,并且例如抵靠脱脂棉13622的底部表面来压缩组织厚度补偿件13620的至少一部分。在各种实施例中,现在参见图333,钉仓例如可包括组织厚度补偿件13120以及外皮或顶层13122。在至少一个此类实施例中,组织厚度补偿件13120例如可包括可从组织厚度补偿件13120的顶部表面13121向上延伸的锥形凸耳、突出部、和/或突起部13128。当钉13030处于其未击发位置时,突出部13128能够容纳和包封钉13030的钉腿13032的末端,如图333所示。顶层13122还可包括与突出部13128对齐或至少基本上对齐的锥形凸耳、突出部、和/或突起部13129。在使用中,钉腿10032可穿透突出部13128和13129,并从组织厚度补偿件13120露出。在各种实施例中,现在参见图337,钉仓例如可包括组织厚度补偿件13520以及外皮或顶层13522。在至少一个此类实施例中,外皮13522例如可包括可从组织厚度补偿件13520的顶部表面13521向上延伸的锥形凸耳、突出部、和/或突起部13529。类似于上文所述,当钉13030处于其未击发位置时,突出部13529能够容纳和包封钉13030的钉腿13032的末端,如图337所示。在使用中,钉腿10032可穿透突出部13529并从外皮13522露出。
在各种实施例中,现在参见图334,钉仓例如可包括组织厚度补偿件13220以及外皮或顶层13222。在至少一个此类实施例中,组织厚度补偿件13220例如可包括可向下延伸到组织厚度补偿件13220的顶部表面13221中的锥形凹坑和/或凹槽13128。在各种实施例中,当钉13030处于其未击发位置时,钉腿13032的末端可延伸穿过凹槽13128,如图334所示。在至少一个实施例中,顶层13222还可包括可与凹槽13228对齐或至少基本上对齐的锥形凹坑和/或凹槽13229。在各种实施例中,现在参见图335,钉仓例如可包括组织厚度补偿件13320以及外皮或顶层13322。在至少一个此类实施例中,外皮13320可包括可向下延伸到组织厚度补偿件13320的顶部表面13321中的厚的部分13329。在各种实施例中,当钉13030处于其未击发位置时,厚的部分13329能够在其中容纳钉13030的钉腿13032的至少一部分,如图335所示。在此类实施例中,厚的部分13329可将钉腿13032保持就位,使得腿13032与定位在组织厚度补偿件13320对面的砧座的钉成形凹坑对齐或至少基本上对齐。在各种实施例中,现在参见图336,钉仓例如可包括组织厚度补偿件13420以及外皮或顶层13422。在至少一个此类实施例中,外皮13422可包括可从组织厚度补偿件13420的顶部表面13421向上延伸的厚的部分13429。在各种实施例中,当钉13030处于其未击发位置时,厚的部分13429能够在其中容纳钉13030的钉腿13032的至少一部分,如图336所示。在此类实施例中,厚的部分13429可将钉腿13032保持就位,使得腿13032与定位在组织厚度补偿件13420对面的砧座的钉成形凹坑对齐或至少基本上对齐。
在各种实施例中,现在参见图339和图340,钉仓例如可包括组织厚度补偿件13720以及外皮或顶层13721。在至少一个此类实施例中,组织厚度补偿件13720例如可包括可从组织厚度补偿件13720的顶部表面13721向上延伸的锥形和/或阶梯式凸耳、突出部、和/或突起部13728。当钉13030处于其未击发位置时,突出部13728能够容纳并包封钉13030的钉腿13032的末端,如图340所示。相似地,顶层13721可包括可与突出部13728对齐或至少基本上对齐的锥形和/或阶梯式凸耳、突出部、和/或突起部13729。在各种实施例中,外皮13721还可包括从突出部13729向上延伸的一个或多个齿状物13727,该齿状物能够接合抵靠顶层13721定位的组织,并且防止或至少限制组织、顶层13721、和/或钉腿13032的末端之间相对的侧向和/或纵向运动。在使用中,当钉13030从其未击发位置运动到其击发位置时,钉腿13032可穿透突出部13728和13729并从组织厚度补偿件13720露出。在各种实施例中,现在参见图341和图342,钉仓例如可包括组织厚度补偿件13820以及外皮或顶层13821。在至少一个此类实施例中,组织厚度补偿件13820例如可包括可从组织厚度补偿件13820的顶部表面13821向上延伸的锥形和/或阶梯式凸耳、突出部、和/或突起部13828。当钉13030处于其未击发位置时,突出部13828能够容纳并包封钉13030的钉腿13032的末端,如图342所示。相似地,顶层13821可包括可与突出部13828对齐或至少基本上对齐的锥形和/或阶梯式凸耳、突出部、和/或突起部13829。在各种实施例中,顶层13821还可包括向下延伸到组织厚度补偿件13820中的一个或多个齿状物13827,该齿状物例如能够防止或至少限制顶层13821和组织厚度补偿件13820之间相对的侧向和/或纵向运动。在使用中,当钉13030从其未击发位置运动到其击发位置时,钉腿10032可穿透突出部13828和13829并从组织厚度补偿件13820露出。
在各种实施例中,现在参见图343,钉仓可包括组织厚度补偿件诸如组织厚度补偿件13920,该组织厚度补偿件例如可包括限定在其中的脊13923和谷13924。在至少一个实施例中,谷13924可被限定在脊13923之间。在各种实施例中,每个脊13923可包括相同的高度、基本上相同的高度、或不同的高度。相似地,每个谷13924可包括相同的深度、基本上相同的深度、或不同的深度。在各种实施例中,多个钉13030可至少部分储存在组织厚度补偿件13920中,使得钉13030的末端可被定位在脊13923中。在至少一个此类实施例中,当钉13030被储存于其未击发位置时,钉13030的钉腿13032例如可不从组织厚度补偿件13920和/或附接到组织厚度补偿件13920的外皮或顶层13921突起。在各种实施例中,脊13923和/或谷13924可横跨钉仓侧向延伸。在至少一个此类实施例中,钉仓可包括纵向刀狭槽,其中脊13923和谷13924可沿横向于和/或垂直于刀狭槽的方向延伸。在各种情况下,脊13923能够将钉腿13032的末端保持就位,直到钉13030从其未击发位置运动到其击发位置。在各种实施例中,现在参见图344,组织厚度补偿件和/或覆盖组织厚度补偿件的外皮可包括纵向脊和/或谷。在至少一个此类实施例中,组织厚度补偿件可包括由脊14023和谷14024限定的顶部表面,其中谷14024例如可被限定在脊14023之间。在各种实施例中,组织厚度补偿件可包括外皮14021,该外皮可包括限定在其中的多个孔14029,每个孔各自能够容纳钉腿13032。在某些实施例中,孔14029可被限定在脊14023中,其中钉腿13032的末端可被定位在脊14029的顶点14028下方、被定位成与顶点14028齐平、和/或被定位在顶点14028上方。在某些实施例中,除了上文所述之外或代替上文所述,孔14029例如可被限定在谷14024中。在某些实施例中,每个孔例如可被压花围绕或至少部分围绕,该压花可增强围绕孔的外皮和/或组织厚度补偿件。在任何情况下,对上文进行进一步描述,外皮14021可以任何合适的方式附接到组织厚度补偿件,例如包括使用至少一种粘合剂。
如上所述并再次参见图233,外科缝合器械例如可包括砧座诸如砧座10060,该砧座可在打开位置和闭合位置之间运动,以便例如抵靠钉仓10000的组织厚度补偿件10020压缩组织T。在各种情况下,砧座10060可朝钉仓10000旋转,直到其向下运动被钉仓10000的某部分和/或定位有钉仓10000的通道的某部分所阻止。在至少一个此类实施例中,砧座10060可向下旋转,直到其向下运动被钉仓10000的鼻部10003和/或定位在鼻部10003和钉仓10000中间的组织T所抵抗。在一些情况下,砧座10060可充分压缩组织厚度补偿件10020,以使组织T接触钉10030的末端。在某些情况下,根据组织T的厚度,砧座10060可充分压缩组织厚度补偿件10020,使得等到砧座10060已到达其完全闭合位置时,砧座10060与钉10030接触。换句话讲,在此类情况下,在击发构件10052被推进到钉仓10000中以击发钉10030之前,砧座10060可使钉10030变形。此类情况在某些实施例中是可接受的;然而现在参见图358和图359,设想了其他实施例。在所述其他实施例中,例如可使用远侧间隙设定元件诸如元件10059来限制如下距离:在击发杆10052被推进到钉仓10000中之前,砧座10060可在该距离处被闭合。在各种实施例中,元件10059可从组织厚度补偿件10020的顶部表面10021向上延伸,使得当组织T抵靠元件10059被压缩并且其间产生抗力时,砧座10060的向下运动可被阻止。在使用中,如上所述,击发构件10052可朝远侧朝向钉仓10000的远端10002被推进到钉仓10000中,以便将钉10030从支撑部分10010射出。同时,击发构件10052可接合砧座10060,并将砧座10060定位在正被成形的钉10030之上、距支撑部分10010的平台表面10011(图218)期望距离。这样,击发构件10052可控制砧座10060的组织接触表面和在具体位置处的平台表面10011之间的距离或间隙。其中,当击发构件10052朝远侧被推进时,该具体位置可朝远侧被推进。在各种情况下,该间隙距离可短于砧座10060和平台表面10011之间的间隙,该间隙由组织厚度补偿件10020的远端处的远侧间隙设定元件10059所控制或决定。在各种实施例中,现在参见图359,当击发构件10052到达组织厚度补偿件10020的远端时,击发构件10052的刀刃10053能够横切远侧间隙设定元件10059,使得当元件10059已被横切之后,击发构件10052可将砧座10060朝向支撑部分10010向下牵拉,并且当在钉仓10000的远端处击发钉10030时,将间隙闭合至期望的间隙高度。在某些可供选择的实施例中,当击发构件接近钉仓的远端时,远侧间隙设定元件能够合拢。在至少一个此类实施例中,远侧间隙设定元件可包括柱形物,该柱形物可如上所述提供针对砧座的阻力,并且当击发构件接近钉仓的远端时一旦达到间隙设定元件的扣紧强度,则该柱形物然后突然扣紧。在至少一个实施例中,该扣紧力例如可为大约10lbf。在某些实施例中,当向间隙设定元件施加例如超过预定量的力时,间隙设定元件能够向下落入支撑部分的平台中。在某些其他实施例中,远侧间隙可被钉仓的鼻部控制。在至少一个此类实施例中,砧座10060的向下运动可被鼻部限制,直到击发构件已到达仓的远端。其中,施加到鼻部的压缩力此时可使鼻部塌缩。在某些实施例中,鼻部可包括由腔壁限定的腔体。一旦施加到腔体的压缩力超过预定的力,则可使腔体塌缩。在至少一个此类实施例中,腔体可由可塌缩壁限定。
在各种实施例中,如上所述,砧座诸如砧座10060例如可在打开位置和闭合位置之间被运动,以便在砧座和钉仓的支撑部分之间压缩组织厚度补偿件。在某些情况下,现在参见图360和图361,当组织厚度补偿件14120抵靠钉仓14100的支撑部分14110被压缩时,钉仓的组织厚度补偿件诸如钉仓14100的组织厚度补偿件14120例如可侧向和/或纵向伸展。在某些实施例中,组织厚度补偿件14120的端部和/或侧面可不被支撑部分14110和/或砧座10060约束。因此,在组织厚度补偿件14120内不产生压缩压力或至少非期望的压缩压力的情况下,组织厚度补偿件14120可沿那些方向伸展。在此类实施例中,击发构件诸如穿过组织厚度补偿件14120的击发构件10052(图236)例如可不会被组织厚度补偿件14120中非期望的压缩力不当阻止。在某些其他实施例中,再次参见图360,组织厚度补偿件14120的远端14125例如可被钉仓14100的鼻部14103约束。在该具体实施例中,类似于上文所述,组织厚度补偿件14120的远端14125可被鼻部14103约束,以便减少组织厚度补偿件14120与支撑部分14110过早分离的可能性。在任何情况下,由于上文所述,大的内部压力可产生于远端14125内,该内部压力可阻止击发构件10052的推进,尤其当击发构件10052到达远端14125时。更具体地,在某些情况下,当击发构件10052横切组织厚度补偿件14120时,击发构件可朝远侧推动、犁除、和/或转移组织厚度补偿件14120。因此,甚至更大的内部压力可产生于组织厚度补偿件14120的远端14125内。为了至少部分消除组织厚度补偿件14120内的该压力,鼻部14103可由柔性材料构成。该柔性材料可使鼻部14103例如朝远侧挠曲,并为组织厚度补偿件14120产生附加的空间。在某些实施例中,现在参见图362和图363,钉仓的鼻部可包括可朝远侧滑动的部分。更具体地,钉仓14200的鼻部14203可包括可滑动部分14204,该可滑动部分能够可滑动地连接至鼻部14203,使得当砧座10060被闭合和/或击发构件10052被推进到钉仓14200的远端中时,可滑动部分14204可朝远侧滑动并为组织厚度补偿件14200产生附加的空间,并且至少部分缓解其中的内部压力。在至少一个实施例中,鼻部14203和可滑动部分14204中的一者可包括一个或多个导轨,并且鼻部14203和可滑动部分14204中的另一者可包括能够在其中滑动地容纳导轨的一个或多个通道。在至少一个此类实施例中,通道和导轨例如能够协作限制可滑动部分14204到纵向远侧通道的运动。
在各种情况下,对上文进行进一步描述,钉仓内的诸如最远侧钉例如可捕获组织厚度补偿件的相较于钉仓内的近侧钉而言更大的部分。在此类情况下,因此,相较于近侧钉而言,可向远侧钉中所捕获的组织施加大的夹紧压力。如上所述,尽管组织厚度补偿件可由具有基本上恒定厚度的基本上同质的材料构成,但是当组织厚度补偿件的至少一部分被转移到和/或在使用期间聚集到钉仓的远端处时,可出现这些情况。在各种情况下,期望某些钉与其他钉相比向组织施加更大的夹紧压力。其中,在各种实施例中,支撑部分和/或组织厚度补偿件可被构造成并被布置成控制哪些钉可向组织施加更大的夹紧力以及哪些钉可向组织施加较小的夹紧力。现在参见图364,钉仓14300可包括支撑部分14310,并且除此之外定位在支撑部分14310的平台表面14311上的组织厚度补偿件14320。与本专利申请中所公开的包括具有平坦的或至少基本上平坦的平台表面的支撑部分14310的其他实施例相比,平台表面14311可在支撑部分14310的远端14305和近端14306之间倾斜和/或下降。在至少一个实施例中,支撑部分14310的平台表面14311可包括其远端14305处的平台高度,该平台高度低于其近端14306处的平台高度。在至少一个此类实施例中,钉仓14300的远端处的钉10030相比于近端处的钉10030可延伸到平台表面14311上方更大的距离。在各种可供选择的实施例中,支撑部分的平台表面可包括其远端处的高度,该高度高于其近端处的高度。再次参见图364,组织厚度补偿件14320可包括沿其纵向长度不同的厚度。在各种实施例中,组织厚度补偿件14320例如可包括其远端14325处的厚度,该厚度厚于其近端14326。在至少一个此类实施例中,组织厚度补偿件14322可包括底部表面14322,该底部表面可倾斜或下降,以匹配或至少基本上匹配支撑部分14310的倾斜或下降的平台表面14311。因此,组织厚度补偿件14320的顶部或组织接触表面14321可包括上面可定位有组织T的平坦的或至少基本上平坦的表面。在任何情况下,由于组织厚度补偿件14320在其远端14325处较厚,因此远侧钉10030相比于近侧钉10030可捕获其中的组织厚度补偿件14320的较大部分。因此,远侧钉10030可向组织T施加更大的压缩力,尤其当砧座10060和平台表面14311之间的间隙距离在钉仓的近端和远端处为恒定的或基本上恒定的时。然而在某些情况下,砧座10060可到达完全闭合位置,因此砧座10060和平台表面14311之间的间隙距离在钉仓14300的远端处比近端处更大。在各种情况下,远侧钉10030可能没有完全成形,应此远侧钉10030可能不向组织T施加期望的夹紧压力。在组织厚度补偿件在钉仓的远端处较厚的实施例中,组织厚度补偿件可补偿未成形钉并向组织T施加足够的压力。
在各种实施例中,现在参见图365,钉仓诸如钉仓14400例如可包括支撑部分14410以及除此之外被定位在支撑部分14410的平台表面14411上的组织厚度补偿件14420。类似于上文所述,平台表面14411可倾斜和/或下降,使得在至少一个实施例中,支撑部分14410的远端14405例如可具有低于近端14406处的平台高度的平台高度。在某些实施例中,组织厚度补偿件14420沿其长度可包括恒定的或至少基本上恒定的厚度。因此,组织厚度补偿件14420的顶部或组织接触表面14421可平行于或至少基本上平行于平台表面14411的轮廓。在各种实施例中,当钉10030处于其未击发位置时,钉仓14400的钉10030可完全嵌入组织厚度补偿件14420和支撑部分14410内。在某些实施例中,当钉10030处于其未击发位置时,被定位在钉仓14400的近端处的钉10030可完全嵌入组织厚度补偿件14420和支撑部分14410内;而由于平台14411和顶部表面14421的下降斜坡,当钉10030处于其未击发位置时,某些钉10030,包括被定位在钉仓14400的远端处的钉10030,可凸穿组织厚度补偿件14420的顶部表面14421。
在各种实施例中,如上所述,组织厚度补偿件可由单个材料构成,其中整个组织厚度补偿件可自始至终具有相同的或至少基本上相同的材料特性,诸如密度、刚度、弹性比率、硬度、和/或弹性。在各种其他实施例中,现在参见图368,组织厚度补偿件诸如组织厚度补偿件14520例如可包括多种材料或材料层。在至少一个实施例中,组织厚度补偿件14520可包括第一或中央层14520a、在其相对侧上附接到第一层14520a的第二或中间层14520b、以及附接到第二层14520b中的每一者的第三或外层14520c。在某些实施例中,可利用至少一种粘合剂将中间层14520b附接到中央层14520a,并且相似地,可使用至少一种粘合剂将外层14520c附接到第二层14520。除了粘合剂之外或代替粘合剂,例如可通过一个或多个互锁结构和/或紧固件将层14520a-14520c保持在一起。在任何情况下,内层14520a例如可由具有第一组材料特性的第一材料构成;中间层14520b可由具有第二组材料特性的第二材料构成;并且外层14520c可由具有第三组材料特性的第三材料构成。这几组材料特性例如可包括密度、刚度、弹性比率、硬度、和/或弹性。在某些实施例中,钉仓例如可包括六排钉10030,其中一排钉10030例如可至少被部分定位在外层14520c中的每一者中以及内层14520b中的每一者中,并且其中两排钉10030可至少被部分定位在内层14520a中。在使用中,类似于上文所述,钉10030可从钉仓射出,使得钉10030的钉腿10032穿透组织厚度补偿件14520的顶部表面14521,穿透由砧座抵靠顶部表面14521而定位的组织、并随后接触砧座,使得腿10032变形以捕获钉10030内的组织厚度补偿件14520和组织。还类似于上文所述,当击发构件被推进穿过钉仓时,组织厚度补偿件14520可被击发构件横切。在至少一个此类实施例中,击发构件例如可沿由轴线14529限定的通道横切内层14520a和组织。
在各种实施例中,对上文进行进一步描述,定位在内层14520a中的多排钉10030可包括最接近被横切的组织的边缘的钉排。相应地,定位在外层14520c中的多排钉10030可包括距离被横切的组织的边缘最远的钉排。在某些实施例中,包括内层14520a的第一材料例如可包括如下密度:该密度高于包括中间层14520b的第二材料的密度;并且相似地,第二材料的密度可高于包括外层14520c的第三材料的密度。在各种情况下,因此,相较于被定位在中间层14520b和外层14520c中的钉10030内产生的压缩力而言,更大的压缩力可在被定位于内层14520a中的钉10030内产生。相似地,相较于被定位在外层14520c中的钉10030内产生的压缩力而言,更大的压缩力可在被定位于中间层14520b中的钉10030内产生。在各种可供选择的实施例中,包括内层14520a的第一材料例如可包括如下密度:该密度低于包括中间层14520b的第二材料的密度;并且相似地,第二材料的密度可低于包括外层14520c的第三材料的密度。在各种情况下,因此,相较于被定位在中间层14520b和内层14520a中的钉10030内产生的压缩力而言,更大的压缩力可在被定位于外层14520c中的钉10030内产生。相似地,相较于被定位在内层14520a中的钉10030内产生的压缩力而言,更大的压缩力可在被定位于中间层14520b中的钉10030内产生。在各种其他实施例中,可使用任何其他合适构造的层、材料、和/或材料特性。在任何情况下,在各种实施例中,组织厚度补偿件14520的层14520a-14520c能够在其被植入后保持彼此附接。在某些其他实施例中,组织厚度补偿件14520的层14520a-14520c能够在其被植入后保持彼此分离。在至少一个此类实施例中,层14520a-14520c可利用一种或多种可生物吸收的粘合剂结合到一起,该一种或多种可生物吸收的粘合剂可首先将层保持到一起,然后随时间推移使层从彼此释放。
如上所述,钉仓的组织厚度补偿件诸如组织厚度补偿件14520例如可包括多个纵向层。在各种其他实施例中,现在参见图369,钉仓可包括组织厚度补偿件诸如组织厚度补偿件14620,该组织厚度补偿件例如可包括多个水平层。在至少一个此类实施例中,组织厚度补偿件14620可包括第一或底层14620a、附接到底层14620a的第二或中间层14620b、以及附接到中间层14620b的第三或顶层14620c。在各种实施例中,第一层14620a例如可包括平坦的或基本上平坦的底部表面14626a以及三角形或锥形的顶部表面14625a。在至少一个此类实施例中,第二层14620b可包括三角形或锥形的底部表面14626b,该底部表面可平行于并邻接第一层14620a的顶部表面14625a。类似于上文所述,第二层14620b可包括三角形或锥形的顶部表面14625b,该顶部表面例如可平行于并邻接第三层14620c的底部三角形或锥形的底部表面14626c。在各种实施例中,第三层14626c的顶部表面可包括平坦的或至少基本上平坦的组织接触表面14621。还类似于上文所述,组织厚度补偿件14620例如能够在其中至少部分地储存六排钉诸如钉10030,其中击发构件例如可沿延伸穿过轴线14629的通道横切两个最内侧的钉排之间的组织厚度补偿件14620。类似于上文所述,每个层14620a,14620b,和14620c可由包括不同材料特性的不同材料构成,并且由于层14620a-14620c的三角形或锥形构型,组织厚度补偿件14620可在其内各个位置处具有不同的总体特性。例如,最外侧的多排钉10030可在其中捕获比第一层14620a更多的第三层14620c,而最内侧的多排钉10030可捕获比第一层14620a更少的第三层14620c。因此,尽管组织厚度补偿件14620可具有横跨其的相同的或至少基本上相同的总体厚度,但是组织厚度补偿件14620例如能够以不同于压缩被捕获在最内侧钉10030内的组织的方式来压缩被捕获在最外侧钉10030内的组织。
在各种实施例中,现在参见图286,钉仓的组织厚度补偿件,诸如钉仓14700的组织厚度补偿件14720,例如可包括限定在其中的可使组织厚度补偿件14720的厚度发生变化的空隙、凹坑、通道、和/或沟槽。在至少一个此类实施例中,组织厚度补偿件14720可抵靠钉仓14700的支撑部分14710的平台表面14711定位,使得限定在组织厚度补偿件14720的底部表面14722中的空隙14723可覆在某些钉腔10012上面而不是其他钉腔上。在各种实施例中,空隙14723可横向于至支撑部分14710的刀狭槽14715、垂直于刀狭槽14715、和/或平行于刀狭槽14715延伸。在某些实施例中,空隙14723可在组织厚度补偿件14720的底部表面14722中限定支承面图案。在任何情况下,当钉诸如钉10030例如从支撑部分14710被部署时,现在参见图287和288,某些钉10030可在包含空隙14723的区域内捕获组织厚度补偿件14720;而其他钉10030可在被定位于空隙14723中间的区域内捕获组织厚度补偿件14720。除了上文所述之外或代替上文所述,组织厚度补偿件14720例如可包括限定在顶部或组织接触表面14721中的空隙、凹坑、通道、和/或沟槽。在某些实施例中,现在参见图366和图367,钉仓14800可包括组织厚度补偿件14820,该组织厚度补偿件可包括多个支承面14823,该多个支承面例如为以下情况中的至少一种:从组织厚度补偿件14820的顶部表面14821向上延伸、朝中央沟槽14825向内延伸、和/或朝钉仓14800的远端朝远侧延伸。在至少一个此类实施例中,支承面14823例如可被通道、狭槽、和/或沟槽诸如通道14824分开。在各种情况下,由于上文所述,组织厚度补偿件的总体厚度可在钉排之间变化和/或在钉排内的钉之间变化。在某些情况下,支承面或厚的部分可被构造为并布置成使得当组织厚度补偿件被压缩时,支承面或厚的部分可沿期望的方向诸如向内流动。
在各种实施例中,现在参见图303,钉仓诸如钉仓14900例如可包括支撑部分14910以及除此之外抵靠支撑部分14910被定位的组织厚度补偿件14920。类似于上文所述,支撑部分14910可包括可由钉部署滑动件向上抬起的钉驱动器,以便抬起钉诸如钉10030,该钉例如朝向砧座,诸如被定位在钉仓14900对面的砧座10060而至少被部分定位在支撑部分14910中。在某些实施例中,支撑部分14910可包括六排钉腔,诸如外侧的两排钉腔、内侧的两排钉腔、以及定位在内侧排和外侧排中间的中间两排钉腔。其中砧座10060可包括与钉腔对齐或至少基本上对齐的六排成形凹坑10062。在各种实施例中,内侧钉腔排可包括定位在其中的钉驱动器14940a;中间钉腔排可包括定位在其中的钉驱动器14940b;并且外侧钉腔排可包括定位在其中的钉驱动器14940c。其中钉驱动器14940a中的每一个可包括能够支撑钉10030的支架14949a;其中钉驱动器14940b中的每一个可包括能够支撑钉10030的支架14949b;并且其中钉驱动器14940c中的每一个可包括能够支撑钉10030的支架14949c。在其未击发位置处,即,当钉驱动器14940a-14940c被置于延伸到支撑部分14910下面的驱动器支撑件14926上时,相比于钉驱动器14940b的支架14949b和钉驱动器14940c的支架14949c,钉驱动器14940a的支架14949a可更靠近砧座10060定位。在此类位置,第一成形距离可被限定在支架14949a和定位在支架14949a之上的成形凹坑10062之间;第二成形距离可被限定在支架14949b和定位在支架14949b之上的成形凹坑10062之间;并且第三成形距离可被限定在支架14949c和定位在支架14949c之上的成形凹坑10062之间。其中,在各种实施例中,例如第一成形距离可短于第二成形距离,并且第二成形距离可短于第三成型距离。当钉驱动器14940a-14940c从其未击发位置(图303)运动到其击发位置时,每个钉驱动器14940a-14940c可被钉部署滑动件朝砧座10060向上运动相等的或至少基本上相等的距离,使得第一驱动器14940a将其各自的钉10030驱动第一成形高度;第二驱动器14940b将其各自的钉10030驱动第二成形高度;并且第三驱动器14940c将其各自的钉10030驱动第三成形高度。其中,例如第一成形高度可短于第二成形高度,并且第二成形高度可短于第三成形高度。设想了各种其他实施例,其中第一钉驱动器14940a被向上移位第一距离;第二钉驱动器14940b被向上移位第二距离,并且第三钉驱动器14940c被向上移位第三距离。其中,第一距离、第二距离、第三距离中的一个或多个可不同。
在各种实施例中,再次参见图303,相对于砧座10060的组织接触表面10061,支撑部分14910的平台表面14911可在高度上有所变化。在某些实施例中,该高度变化可在侧向上产生,并且在至少一个实施例中,例如围绕内侧钉腔排的平台表面14911的高度可高于围绕外侧钉腔排的平台表面14911的高度。在各种实施例中,组织厚度补偿件14920的底部表面14922可平行于或至少基本上平行于支撑部分14910的平台表面14911。对上文进行进一步描述,组织厚度补偿件14920还可在厚度上有所变化。其中,在至少一个实施例中,组织厚度补偿件14920的顶部或组织接触表面14921可从其外边缘或侧向边缘向内倾斜。在至少一个此类实施例中,由于上文所述,组织厚度补偿件14920可在被定位于内侧钉腔排之上的区域内较薄,并且在被定位于外侧钉腔排之上的区域内较厚。在各种实施例中,现在参见图304,支撑部分15010的平台表面例如可包括阶梯式平台表面,其中阶梯式表面的最高台阶可围绕内侧钉腔排,并且阶梯式表面的最低台阶可围绕外侧钉腔排。在至少一个此类实施例中,具有中间高度的台阶可围绕中间钉腔排。在某些实施例中,组织厚度补偿件诸如组织厚度补偿件15020例如可包括底部表面,该底部表面平行于且邻接支撑部分15010的平台表面。在至少一个实施例中,组织厚度补偿件的顶部或组织接触表面15021例如可包括弓形的、抛物线的、和/或弯曲的表面,在至少一个此类实施例中,该表面可从组织厚度补偿件15020的第一横向侧延伸到组织厚度补偿件15020的第二横向侧,其中顶点与钉仓15000的中心对齐或至少基本上对齐。在各种实施例中,现在参见图299,钉仓15300例如可包括支撑部分15310、可运动地定位在限定于支撑部分15310中的钉腔内的多个钉驱动器15340、以及定位在支撑部分15310的平台表面15311上方的组织厚度补偿件15320。钉仓15300还可包括一个或多个底部盘部分15326,该底部盘部分可附接到支撑部分15310并延伸到支撑部分15310的底部周围,并支撑驱动器15340和处于其未击发位置的钉15330。当钉部署滑动件被推进穿过钉仓时,随着滑动件将钉驱动器15340和钉15330向上抬起穿过组织厚度补偿件15320,滑动件还可由底部盘部分15326支撑。在至少一个实施例中,组织厚度补偿件15320可包括定位在内侧钉腔排之上的第一或内部15322a、定位在中间钉腔排之上的第二或中间部分15322b、以及定位在一排钉腔之上的第三或外部15322c。其中,例如内部15322a可厚于中间部分15322b,并且中间部分15322b可厚于外部15322c。在至少一个实施例中,组织厚度补偿件15320例如可包括限定在其中的纵向通道,该纵向通道可产生组织厚度补偿件15320的较薄部分15322b和15322c。在各种可供选择的实施例中,纵向通道可被限定在组织厚度补偿件的顶部表面和/或底部表面中。在至少一个实施例中,组织厚度补偿件15320的顶部表面15321例如可包括平坦的或至少基本上平坦的表面。
在各种实施例中,现在参见图296,钉仓例如可包括组织厚度补偿件诸如组织厚度补偿件15120,该组织厚度补偿件可包括具有不同厚度的多个部分。在至少一个实施例中,组织厚度补偿件15120可包括具有第一厚度的第一或内部15122a、从第一部分15122a延伸的可具有第二厚度的第二或中间部分15122b、以及从第二部分15122b延伸的可具有第三厚度的第三或外部15122c。在至少一个此类实施例中,例如第三厚度可厚于第二厚度,并且第二厚度可厚于第一厚度,但在各种其他实施例中可使用任何合适的厚度。在各种实施例中,组织厚度补偿件15120的部分15122a-15122c可包括具有不同厚度的台阶。在至少一个实施例中,类似于上文所述,钉仓可包括多排钉10030和具有不同高度的多个钉驱动器,该钉驱动器可使钉10030变形至不同的成形高度。还类似于上文所述,钉仓可包括第一钉驱动器15140a,其可驱动支撑在其上的钉10030至第一成形高度、第二钉驱动器15140b,其可驱动支撑在其上的钉10030至第二成形高度、以及第三钉驱动器,其可驱动支撑在其上的钉10030至第三成形高度。其中,例如第一成形高度可短于第二成形高度,并且第二成形高度可短于第三成形高度。在各种实施例中,如图296所示,每个钉10030可包括相同的或基本上相同的未成形或未击发高度。在某些其他实施例中,现在参见图296A,第一驱动器15140a、第二驱动器15140b、和/或第三驱动器15140c可支撑具有不同未成形高度的钉。在至少一个此类实施例中,第一钉驱动器15140a可支撑具有第一未成形高度的钉15130a,第二钉驱动器15140b可支撑具有第二未成形高度的钉15130b,并且第三钉驱动器15140c可支撑具有第三未成形高度的钉15130c。其中,例如第一未成形高度可短于第二未成形高度,并且第二未成形高度可短于第三未成形高度。在各种实施例中,再次参见图296A,钉15130a,15130b和/或15130c的末端可位于或至少基本上位于相同的平面中,而在其他实施例中,钉15130a,15130b和/或15130c的末端可不位于相同的平面中。在某些实施例中,现在参见图297,钉仓可包括具有多个部分的组织厚度补偿件15220,该多个部分具有不同的厚度,该组织厚度补偿件可通过钉15130a,15130b和15130c被抵靠组织T而植入,如上所述。在至少一个实施例中,现在参见图298,钉15130a,15130b和/或15130c可变形至不同的成形高度。其中第一钉15130a可变形至第一成形高度,第二钉15130b可变形至第二成形高度,并且第三钉15130c可变形至第三成形高度,并且其中第一成形高度例如可短于第二成形高度,并且第二成形高度可短于第三成形高度。设想了其他实施例,其中钉15130a,15130b和15130c可成形为任何合适的成形高度和/或任何相对的成形高度。
在各种实施例中,如上所述,外科缝合器械的砧座可在打开位置和闭合位置之间运动。在此类情况下,当砧座运动到其闭合位置时,砧座的组织接触表面可运动到其最终的或成形位置。一旦砧座处于其闭合位置,在某些实施例中,组织接触表面可不再为可调式的。在某些其他实施例中,现在参见图351,外科缝合器诸如外科缝合器15500例如可包括砧座通道15560以及定位在砧座通道15560内的可调式组织接触砧座调节板15561。在此类实施例中,砧座板15561可在砧座通道15560内被提升和/或降低,以便相对于定位在砧座板15561对面的钉仓来调节砧座板15561的组织接触表面的位置。在各种实施例中,外科缝合器15500可包括调节滑块15564。参见图356和图357,该调节滑块可在砧座通道15560和砧座板15561中间滑动,以便控制砧座板15561和钉仓之间的距离。在某些实施例中,再次参见图351和图352,外科缝合器15500还可包括联接至调节滑块15564的致动器15562,该致动器可朝近侧滑动以便使调节滑块15564朝近侧滑动、和/或朝远侧滑动以便使调节滑块15564朝远侧滑动。在各种实施例中,再次参见图356和图357,致动器15562可在两个或更多个预定位置之间滑动,以便分别在两个或更多个位置之间调节砧座板15561。在至少一个实施例中,此类预定位置例如可在外科缝合器15500上被划分为分界线15563(图351)。在某些实施例中,参见图357,调节滑块15564例如可包括多个支撑表面,诸如第一支撑表面15565a、第二支撑表面15565b和第三支撑表面15565c,该多个支撑表面可分别与砧座板15561的背面上的多个板定位表面对齐,诸如第一定位表面15569a、第二定位表面15569b和第三定位表面15569c,以便将砧座板15561定位在第一位置。为了将砧座板15561定位在第二位置中,致动器15562和滑块15564例如可朝近侧滑动,以便将滑块15564的支撑表面15565a-15565c相对于砧座板15561的定位表面15569a-15569c重新对齐。更具体地,参见图356,滑块15564可朝远侧滑动,使得滑块15564的第一支撑表面15565a可被定位在砧座板15561的第二定位表面15569b后面,并且使得滑块15564的第二支撑表面15565b可被定位在砧座板15561的第三定位表面15569c后面,以便将砧座板15561运动到更靠近钉仓。当砧座板15561从其第一位置运动到其第二位置时,在此类情况下,可调式砧座板15561可进一步压缩定位在砧座板15561和钉仓之间的组织T。除了上文所述之外,当砧座板15561被调节并且限定在砧座板15561中的成形凹坑将运动到更靠近和/或更远离钉仓时,钉的成形高度可由砧座板15561相对于钉仓的位置来控制。尽管上文仅描述了两个位置,但是滑块15564可滑动到合适数量的位置中,以将砧座板15561运动到更靠近和/或更远离钉仓。在任何情况下,一旦砧座板15561已被正确定位,钉部署滑动件15550可在钉仓内朝远侧滑动,以便将钉驱动器15540和钉15530朝向砧座板15561抬起并缝合组织T,如图354所示。相似的外科缝合器公开于2011年2月28日提交的名称为“SURGICAL STAPLING INSTRUMENT”的美国专利申请序列号13/036,647,其全部公开内容以引用方式并入本文。
在各种实施例中,现在参见图353,钉仓可被定位在外科缝合器15500的钉仓通道15570内,该钉仓通道例如可包括组织厚度补偿件,诸如组织厚度补偿件15520。当砧座板15561朝钉仓运动时,如上所述,砧座板15561可压缩组织厚度补偿件15520和/或定位在砧座板15561和组织厚度补偿件15520中间的组织T。当钉15530从钉仓被部署时,参见图355,钉15530可抵靠组织T压缩并植入组织厚度补偿件15520。在各种实施例中,当砧座板15561抵靠滑块15564定位并且组织还未被置于砧座板15561和组织厚度补偿件15520之间时,可当砧座板15561处于其第一位置时在砧座板15561和组织厚度补偿件15520的顶部表面15521之间限定间隙。当砧座板15561运动到第二位置时,砧座板15561可接触组织厚度补偿件15520。在各种可供选择的实施例中,当砧座板15561抵靠滑块15564定位并且组织还未被置于砧座板15561和组织厚度补偿件15520之间时,可当砧座板15561处于其第一位置和/或第二位置时在砧座板15561和组织厚度补偿件15520的顶部表面15521之间限定间隙。在至少一个此类实施例中,砧座板15561可不与组织厚度补偿件15520接触。在另外的可供选择的实施例中,当砧座板15561抵靠滑块15564定位并且组织还未被置于砧座板15561和组织厚度补偿件15520之间时,砧座板15561例如可与组织厚度补偿件15520的顶部表面15521接触,而不论砧座板15561是否处于第一位置和/或第二位置。尽管本文仅描述了砧座板15611的两个位置,砧座板15611可被定位或索引到任何合适数量的位置中。
在各种实施例中,由于上文所述,外科缝合器械可包括用于调节钉的成形高度的装置,该装置可在各种情况下补偿不同的组织厚度。此外,外科缝合器械例如可包括用于补偿不同的组织厚度和/或组织内的厚度变化的装置。在至少一个此类实施例中,砧座板15561可被向上调节或调节成远离相对的钉仓,以增加钉的成形或击发高度。相应地,砧座板15561可被向下或朝向相对的钉仓调节,以减少钉的成形或击发高度。在各种实施例中,对砧座板15561的调节例如可调节限定在砧座板15561中的成形凹坑之间的间隙、以及钉驱动器的击发高度、或更具体地例如钉驱动器支架的击发高度。即使具有调节钉的成形高度的此类能力以例如负责处理较厚和/或较薄的组织,组织厚度补偿件还可补偿较厚和/或较薄的组织,和/或补偿组织内的厚度变化,如上所述。在此类实施例中,可在同一个外科缝合器械内为外科医生提供多个补偿装置。
如上所述并如多个实施例所示,外科缝合器械可使用钉仓,该钉仓具有线性布置的钉腔和钉,其中击发构件可朝远侧被推进穿过钉仓以从钉腔部署钉。在某些实施例中,钉仓可包括弯曲的钉腔和钉排。在至少一个实施例中,现在参见图345和图346,外科缝合器械诸如缝合器15600例如可包括限定在圆形或环形支撑部分15610中的一个或多个圆形或环形钉腔排。此类圆形钉排例如可包括圆形的内侧钉腔15612排和圆形的外侧钉腔15613排。在至少一个此类实施例中,圆形的钉腔排可围绕限定在缝合器15600中的圆形或环形孔15615,该孔可容纳可移除地定位在其中的圆形或环形刀。在使用中,组织可抵靠支撑部分15610的平台表面15611定位,并且砧座(未示出)可通过延伸穿过和/或定位在孔15615内的致动器组装到外科缝合器15600,使得当致动器被致动时,砧座可朝支撑部分15610被夹紧,并且抵靠平台表面15611压缩组织。一旦组织已被充分压缩,定位在钉腔15612和15613中的钉可从支撑部分15610射出并穿过组织,使得钉可接触砧座并充分变形以捕获其中的组织。当钉正被击发和/或当钉已被击发之后,圆形刀可被推进以横切组织。然后,砧座可运动远离支撑部分15610和/或与外科缝合器15600分离,使得砧座和外科缝合器15600可从手术部位被移除。此类外科缝合器15600和此类外科技术在各种实施例中可被利用,以例如连接大肠的两部分。在各种情况下,圆形钉行能够在组织愈合的情况下将大肠的多个部分保持在一起,并与此同时使大肠的多个部分弹性伸展。相似的外科缝合器械和外科技术公开于1994年2月15日提交的名称为“SURGICAL ANASTOMOSIS STAPLINGINSTRUMENT”的美国专利5,285,945中,其全部公开内容以引用方式并入本文。
在各种实施例中,对上文进行进一步描述,组织厚度补偿件例如可抵靠外科缝合器15600的支撑部分15610定位和/或附接到外科缝合器15600的支撑部分15610。在至少一个实施例中,组织厚度补偿件可由圆形或环形材料环构成,该材料环例如包括内半径和外半径。在某些情况下,组织可抵靠该材料环定位,并且当砧座用于将组织朝支撑部分15610运动时,组织厚度补偿件可在组织和平台表面15611之间被压缩。在使用期间,钉可被击发穿过组织厚度补偿件和组织,使得钉接触砧座并变形至其击发位置,以将组织和组织厚度补偿件的部分捕获在钉内。在各种情况下,对上文进行进一步描述,包括组织厚度补偿件的材料环必须足够有回弹力,以使围绕钉行的大肠的多个部分伸展。在各种实施例中,再次参见图345和图346,柔性的组织厚度补偿件15620例如可包括圆形或环形的柔性内环15624,该内环在至少一个实施例中可限定圆形或环形孔15625。在某些实施例中,内环15624可被构造为使其不被捕获在从外科缝合器15600部署的钉内;相反,在至少一个实施例中,内环15624可以相对于内侧钉腔15612排径向向内定位。在至少一个此类实施例中,组织厚度补偿件15620可包括例如从其延伸的多个附接件,诸如内附接件15622和外附接件15623,使得当钉变形时附接件可至少被部分捕获在钉内。更具体地,首先参见图345,每个内附接件15622可包括如下头部:该头部被定位在限定于外科缝合器15600中的钉腔15612之上,其中头部例如可通过颈部15626附接到内环15624;并且相似地每个外附接件15623可包括如下头部:该头部被定位在限定于外科缝合器15600中的钉腔15613之上,其中头部例如可通过颈部15627附接到内环15624。在各种实施例中,内附接件15622和外附接件15623的头部例如可包括任何合适的形状,诸如圆形、卵形和/或椭圆形。颈部15626和/或15627还可包括任何合适的形状,其中在至少一个实施例中,将外附接件15623的头部连接到内环15624的颈部15627能够在支撑部分15610中的相邻的内侧钉腔15612之间延伸,使得颈部15627不被捕获在从内侧钉腔15612部署的钉内。
在各种实施例中,现在参见图347和图348,柔性的组织厚度补偿件15720例如可包括圆形的或环形的柔性外环15724。在某些实施例中,外环15724可被构造为使其不被捕获在从外科缝合器15600部署的钉内;而是,在至少一个实施例中,外环15724可以相对于外侧钉腔15613排径向向外定位。在至少一个此类实施例中,组织厚度补偿件15720可包括例如从其延伸的多个附接件,诸如内附接件15622和外附接件15623,使得当钉变形时附接件可至少被部分捕获在钉内。更具体地,首先参见图347,每个内附接件15622可包括如下头部:该头部被定位在限定于外科缝合器15600中的钉腔15612之上,其中头部例如可通过颈部15726附接到外环15724;并且相似地每个外附接件15623可包括如下头部:该头部被定位在限定于外科缝合器15600中的钉腔15613之上,其中头部例如可通过颈部15727附接到外环15724。在各种实施例中,内附接件15622和外附接件15623的头部例如可包括任何合适的形状,诸如圆形、卵形和/或椭圆形。颈部15726和/或15727还可包括任何合适的形状,其中在至少一个实施例中,将内附接件15622的头部连接到外环15724的颈部15727能够在相邻的外侧钉腔15613之间延伸,使得颈部15726不被捕获在从外侧钉腔15613部署的钉内。在某些可供选择的实施例中,组织厚度补偿件可包括圆形或环形的柔性内环、圆形或环形的柔性外环、以及除此之外可连接至内环和/或外环的多个附接件。在至少一个实施例中,某些附接件可连接至内环,并且某些其他附接件可连接至外环。在某些实施例中,附接件中的至少一些可连接至内环和外环两者。在任何情况下,对上文进行进一步描述,组织厚度补偿件15620的内环15624、组织厚度补偿件15720的外环15724、和/或任何其他合适的组织厚度补偿件能够弹性伸展和/或收缩,以便适应组织的伸展和/或收缩,该组织厚度补偿件已抵靠该组织被植入。此外,尽管各种实施例在本文被描述为包括圆形或环形支撑环,但是组织厚度补偿件可包括用于将附接件连接至其的任何合适形状的支撑结构。在各种实施例中,对上文进行进一步描述,由外科缝合器推进以对被捕获在砧座和支撑部分之间的组织进行切割的圆形刀还可切割支撑材料。在至少一个此类实施例中,刀可例如可通过切割附接件的颈部将内支撑环与附接件分开。
在各种实施例中,对上文进行进一步描述,组织厚度补偿件可包括可分离的和/或相对可运动的位置,该位置能够使组织厚度补偿件伸展和/或收缩,以便适应组织的运动,该组织厚度补偿件已抵靠该组织被植入。现在参见图349和图350,当组织厚度补偿件15820正抵靠组织被植入时,圆形或环形的组织厚度补偿件15820可抵靠可被保持在未伸展位置(图349)的外科缝合器15600的平台表面15611定位,和/或由可被保持在未伸展位置的外科缝合器15600的平台表面15611支撑;当组织厚度补偿件15820已被植入后,组织厚度补偿件15820能够向外伸展,如图350所示。在各种实施例中,组织厚度补偿件15820可包括多个弓形部分15822,该多个弓形部分例如可通过内环15824被连接在一起。在至少一个实施例中,弓形部分15822可被接缝15828彼此分开。在至少一个其他实施例中,弓形部分15822可彼此连接,其中在至少一个此类实施例中,孔的构造可使弓形部分15822彼此分开。在任何一种情况下,在各种实施例中,弓形部分15822例如可包括互锁结构,诸如突出部15826和凹口15823,该互锁结构可协作以在组织厚度补偿件15820被植入之前限制弓形部分15822之间的相对运动。对上文进行进一步描述,每个弓形部分15822例如可通过一个或多个连接器15827连接至内环15824,该一个或多个连接器能够将弓形部分15822可释放地保持就位。当已使用钉例如储存在支撑部分15610内的钉10030来抵靠组织植入组织厚度补偿件15620后,首先参见图350,连接器15827可与内环15824分离,并使组织厚度补偿件15820至少部分伸展以适应下面的组织内的运动。在各种情况下,所有弓形部分15822可与内环15824分离,而在其他情况下,弓形部分15822中的仅一些可与内环15824分离。在某些可供选择的实施例中,弓形部分15822可由柔性部分连接,该柔性部分可使弓形部分15822相对于彼此运动但不彼此分离。在至少一个此类实施例中,柔性部分可不在其中容纳钉,并能够伸展和/或收缩以适应弓形部分15822的相对运动。在图349和图350所示的实施例中,组织厚度补偿件15820例如可包括八个弓形部分15822。在某些其他实施例中,组织厚度补偿件例如可包括任何合适数量的弓形部分,诸如两个或更多个弓形部分。
对上文进行进一步描述,组织厚度补偿件15620,15720和/或15820例如能够补偿被捕获在砧座和外科器械15600的支撑部分15610之间的较厚和/或较薄的组织。在各种实施例中,类似于上文所述,可通过朝向和/或远离支撑部分15610运动砧座来调节钉的成形或击发高度。更具体地,砧座可运动到更靠近支撑部分15610以减少钉的成形高度,而相应地,砧座可被进一步运动到远离支撑部分15610以增加钉的成形高度。在此类实施例中,因此,外科医生可将砧座调节成远离支撑部分15610以负责处理厚组织,并且调节成朝向支撑部分15610以负责处理薄组织。在各种其他实施例中,外科医生可决定不调节砧座,并依靠组织厚度补偿件来负责处理较薄和/或较厚的组织。在各种实施例中,因此,外科器械15600可包括至少两个装置用于补偿不同的组织厚度和/或组织厚度变化。
在各种实施例中,如上所述,组织厚度补偿件可附接到钉仓的支撑部分。在某些实施例中,组织厚度补偿件的底部表面可包括钩层或套环层中的一者,而支撑部分的平台表面可包括钩层和套环层中的另一者。在至少一个此类实施例中,钩和套环能够彼此接合并将组织厚度补偿件可释放地保持到支撑部分。在各种实施例中,每个钩例如可包括从颈部延伸的扩大的头部。在某些实施例中,包括套环的多个垫例如可粘合到组织厚度补偿件的底部表面,而包括钩的多个垫可粘合到支撑部分的平台表面。在至少一个实施例中,支撑部分例如可包括一个或多个孔和/或凹槽,该一个或多个孔和/或凹槽能够在其中容纳包括钩和/或套环的插入物。除了上文所述之外或代替上文所述,组织厚度补偿件例如能够使用此类钩和套环被可移除地安装到砧座。在各种实施例中,钩和套环例如可包括纤维表面。
在各种实施例中,如上所述,钉仓可包括支撑部分和附接到支撑部分的组织厚度补偿件。在某些实施例中,还如上所述,支撑部分可包括能够在其中容纳切割构件的纵向狭槽,并且组织厚度补偿件可包括可被保持在纵向狭槽中的保持构件。在至少一个实施例中,现在参见图386,钉仓16000可包括支撑部分16010,该支撑部分包括平台表面16011和纵向狭槽16015。钉仓16000还可包括定位在平台表面16011上方的组织厚度补偿件16020。在各种实施例中,组织厚度补偿件16020可包括向下延伸到纵向狭槽16015中的纵向保持构件16025。在至少一个此类实施例中,保持构件16025可被下压到狭槽16015中,使得保持构件16025和狭槽16015之间的相互作用可抵制支撑部分16010和组织厚度补偿件16020之间的相对运动。在各种实施例中,组织厚度补偿件16020的主体可由第一材料构成,并且保持构件16025可由第二或不同材料构成。在某些实施例中,组织厚度补偿件16020的主体可由具有第一硬度的材料构成,并且保持构件16025可由具有第二硬度的材料构成,其中第二硬度例如可高于第一硬度。在使用中,在至少一个实施例中,钉10030可被钉驱动器10040向上推动,使得钉10030的末端可穿过组织厚度补偿件16020的主体并从组织接触表面16021露出,并抵靠靶组织捕获组织厚度补偿件16020的至少一部分。在各种实施例中,当钉10030正被部署时,穿过狭槽16015的切割构件可横切保持构件16025。一旦组织厚度补偿件16020已被植入,在各种实施例中,保持构件16025被牵拉出狭槽16015。在某些其他实施例中,组织厚度补偿件16020的主体能够与保持构件16025分离。
现在参见图387和图389,钉仓17000可包括支撑部分17010,该支撑部分包括平台表面17011和纵向狭槽17015。钉仓17000还可包括定位在平台表面17011上方的组织厚度补偿件17020。在各种实施例中,组织厚度补偿件17020可包括向下延伸到纵向狭槽17015中的纵向保持构件17025。在至少一个此类实施例中,保持构件17025可被下压到狭槽17015中,使得保持构件17025和狭槽17015之间的相互作用可抵制支撑部分17010和组织厚度补偿件17020之间的相对运动。在各种实施例中,保持构件17025可延伸穿过整个组织厚度补偿件17020至其顶部表面17021,其中组织厚度补偿件17020的主体部分17024可附接到保持构件17025的相对侧。在至少一个此类实施例中,保持构件17025还能够例如抵制组织厚度补偿件17020的侧向偏转。在各种实施例中,主体部分17024可由第一材料构成,并且保持构件17025可由第二或不同材料构成。在某些实施例中,主体部分17024可由具有第一硬度的材料构成,并且保持构件17025可由具有第二硬度的材料构成,其中第二硬度例如可高于第一硬度。在各种实施例中,对上文进行进一步描述,当钉10030正被部署时,穿过狭槽17015的切割构件可横切保持构件17025。一旦组织厚度补偿件17020已被植入,在各种实施例中,保持构件17025被牵拉出狭槽17015。在某些其他实施例中,主体部分17024能够与保持构件17025分离。
现在参见图388,钉仓18000可包括支撑部分18010,该支撑部分包括平台表面18011和纵向狭槽18015。钉仓18000还可包括定位在平台表面18011上方的组织厚度补偿件18020。在各种实施例中,组织厚度补偿件18020可包括向下延伸到纵向狭槽18015中的纵向保持构件18025。在至少一个此类实施例中,保持构件18025可被下压到狭槽18015中,使得保持构件18025和狭槽18015之间的相互作用可抵制支撑部分18010和组织厚度补偿件18020之间的相对运动。在各种实施例中,保持构件18025可延伸穿过整个组织厚度补偿件18020至其顶部表面18021,其中组织厚度补偿件18020的主体部分18024可附接到保持构件18025的相对侧。在至少一个实施例中,保持构件18025可包括放大部分18026,该放大部分可容纳在限定于狭槽18015中的腔体18016内。在至少一个此类实施例中,放大部分18026可抵制保持构件18025从狭槽18015撤出。
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,在任一种情况下,所述装置均可进行修复,以在至少一次使用后再次使用。重新修复可包括如下步骤的任意组合:拆卸该装置、然后清洗或置换某些部分以及随后组装。具体地,所述装置可以拆卸,而且可以任意组合选择性地置换或移除该装置任意数目的特定零件或部分。清洗和/或置换特定部分后,该装置可以在修复设施处重新组装以便随后使用,或者在即将进行外科手术前由外科手术队重新组装。本领域的技术人员将会知道,装置的修复可利用多种用于拆卸、清洗/置换和重新组装的技术。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。
优选的是,在手术前处理本文所述的装置。首先,获取新的或用过的装置,并在必要时对装置进行清洁。然后对装置进行消毒。在一种消毒技术中,将该装置置于闭合并密封的容器中,例如塑料或TYVEK袋中。然后将容器和装置置于能够穿透该容器的辐射区,例如γ辐射、x-射线或高能电子。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。
以引用方式全文或部分地并入本文的任何专利、公布或其他公开材料均仅在所并入的材料不与本发明所述的现有定义、陈述或其他公开材料相冲突的范围内并入本文。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的材料。如果据述以引用方式并入本文但与本文所述的现有定义、陈述或其他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。
尽管已经将本发明作为示例性设计进行了描述,但还可以在本公开的实质和范围内对本发明进行修改。因此本专利申请旨在涵盖采用本发明一般原理的任何变型型式、用途或改型。此外,本专利申请旨在涵盖本发明所属领域中出自已知或惯有实践范围内的脱离本公开的型式。
Claims (20)
1.一种与外科缝合器一起使用的钉仓,所述钉仓包括:
仓体,所述仓体包括:
近端;
远端;
在所述近端和所述远端之间延伸的平台;
定位在所述平台上方的植入式可压缩部分,其中所述可压缩部分包括阶梯式表面,所述阶梯式表面包括第一台阶和第二台阶,所述第一台阶包括第一厚度,所述第二台阶包括第二厚度,并且其中所述第一厚度不同于所述第二厚度;以及
限定在所述平台内的多个钉腔,其中所述钉腔沿着限定在所述近端和所述远端之间的钉成形路径定位,其中所述第一厚度和所述第二厚度沿着所述钉成形路径定位,并且其中每个所述钉腔包括位于所述平台中的开口;以及
多个钉,其中每个所述钉的至少一部分可移除地存储于所述钉腔内,其中每个所述钉能够在未击发位置和击发位置之间运动,其中当每个所述钉在所述未击发位置和所述击发位置之间运动时,每个所述钉能够在未击发构型和击发构型之间变形,并且其中所述可压缩部分能够捕获在所述钉内,并且当所述钉在所述未击发构型和所述击发构型之间变形时,所述可压缩部分在不同的所述钉内采取不同的压缩高度。
2.根据权利要求1所述的钉仓,其中所述平台包括沿着所述钉成形路径定位的多个第一台阶和多个第二台阶。
3.根据权利要求1所述的钉仓,其中所述第一台阶与所述第二台阶交替。
4.根据权利要求3所述的钉仓,其中所述组织厚度补偿件还包括在所述第一台阶和所述第二台阶之间延伸的倾斜表面。
5.根据权利要求1所述的钉仓,其中所述钉成形路径包括第一成形路径,其中所述钉腔沿着限定在所述近端和所述远端之间的第二钉成形路径定位,其中所述第二钉成形路径平行于所述第一钉成形路径,并且其中多个所述第一台阶和多个所述第二台阶沿着所述第二钉成形路径定位。
6.根据权利要求5所述的钉仓,其中沿着所述第一钉成形路径定位的所述第一台阶相对于沿着所述第二钉成形路径定位的所述第一台阶偏置,并且其中沿着所述第一钉成形路径定位的所述第二台阶相对于沿着所述第二钉成形路径定位的所述第二台阶偏置。
7.根据权利要求5所述的钉仓,其中沿着所述第一钉成形路径定位的所述第一台阶与沿着所述第二钉成形路径定位的所述第一台阶对齐,并且其中沿着所述第一钉成形路径定位的所述第二台阶与沿着所述第二钉成形路径定位的所述第二台阶对齐。
8.根据权利要求1所述的钉仓,其中所述组织厚度补偿件还包括第三台阶,所述第三台阶包括第三厚度,其中所述第三厚度不同于所述第一厚度和所述第二厚度,并且其中所述第三台阶沿着所述钉成形路径定位。
9.根据权利要求1所述的钉仓,其中所述钉成形路径是直的。
10.一种与外科缝合器一起使用的钉仓,所述钉仓包括:
仓体,所述仓体包括:
近端;
远端;
在所述近端和所述远端之间延伸的平台,其中所述平台包括波状表面,所述波状表面包括多个峰和多个谷;以及
限定在所述平台内的多个钉腔,其中所述钉腔沿着限定在所述近端和所述远端之间的钉成形路径定位,其中所述峰和谷沿着所述钉成形路径定位,其中每个所述钉腔包括位于所述平台中的开口,并且其中至少一个钉腔开口限定在所述峰内,并且至少一个钉腔开口限定在所述谷内;
邻近所述支撑部分定位的植入式可压缩部分,其中所述可压缩部分能够适形于所述波状表面;以及
多个钉,其中每个所述钉的至少一部分可移除地存储于所述钉腔内,其中每个所述钉能够在未击发位置和击发位置之间运动,其中当每个所述钉在所述未击发位置和所述击发位置之间运动时,每个所述钉能够在未击发构型和击发构型之间变形,并且其中所述可压缩部分能够捕获在所述钉内,并且当所述钉在所述未击发构型和所述击发构型之间变形时,所述可压缩部分在不同的所述钉内采取不同的压缩高度。
11.根据权利要求10所述的钉仓,其中所述峰与所述谷交替。
12.根据权利要求10所述的钉仓,其中所述钉成形路径是直的。
13.一种与外科缝合器一起使用的钉仓,所述钉仓包括:
仓体,所述仓体包括:
平台;以及
限定在所述平台内的多个钉腔,其中所述钉腔沿着钉成形路径定位,并且其中每个所述钉腔包括位于所述平台中的开口;
邻近所述平台定位的植入式可压缩部分,其中所述可压缩部分能够适形于所述平台表面,其中所述可压缩部分包括限定于其中的至少一个空隙,并且其中所述至少一个空隙沿着所述钉成形路径定位;以及
多个钉,其中每个所述钉的至少一部分可移除地存储于所述钉腔内,其中每个所述钉能够在未击发位置和击发位置之间运动,其中当每个所述钉在所述未击发位置和所述击发位置之间运动时,每个所述钉能够在未击发构型和击发构型之间变形,并且其中所述可压缩部分能够捕获在所述钉内,并且当所述钉在所述未击发构型和所述击发构型之间变形时,所述可压缩部分在不同的所述钉内采取不同的压缩高度。
14.根据权利要求13所述的钉仓,其中所述至少一个空隙包括与所述钉成形路径对齐的沟槽。
15.根据权利要求13所述的钉仓,其中所述钉腔被布置成第一纵向排和第二纵向排,并且其中所述至少一个空隙包括定位在所述第一纵向排中的所述钉腔的所述开口之上的沟槽。
16.根据权利要求15所述的钉仓,其中所述沟槽定位在所述第二纵向排中的所述钉腔的所述开口之上。
17.根据权利要求16所述的钉仓,其中所述沟槽具有与钉腔的所述第一纵向排对齐的第一深度以及与钉腔的所述第二纵向排对齐的第二深度。
18.根据权利要求13所述的钉仓,其中所述钉腔被布置成第一纵向排和第二纵向排,并且其中所述至少一个空隙包括定位在所述第一纵向排中的所述钉腔的所述开口之上的第一沟槽以及定位在所述第二纵向排中的所述钉腔的所述开口之上的第二沟槽。
19.根据权利要求18所述的钉仓,其中所述第一沟槽包括第一深度,并且所述第二沟槽包括第二深度。
20.根据权利要求13所述的钉仓,其中所述至少一个空隙包括多个封闭的凹坑。
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CN201280031895.4A Active CN103619268B (zh) | 2010-09-30 | 2012-04-13 | 包括具有不同特性的部分的组织厚度补偿件 |
CN201280032663.0A Active CN103635151B (zh) | 2010-09-30 | 2012-04-13 | 包括可释放部分的钉仓 |
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