CN103140182B - 包括多个层的可植入紧固件仓 - Google Patents
包括多个层的可植入紧固件仓 Download PDFInfo
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- CN103140182B CN103140182B CN201180047613.5A CN201180047613A CN103140182B CN 103140182 B CN103140182 B CN 103140182B CN 201180047613 A CN201180047613 A CN 201180047613A CN 103140182 B CN103140182 B CN 103140182B
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- staple
- nail bin
- end effector
- anvil block
- percussion
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Abstract
本发明提供了一种紧固件仓,所述紧固件仓可包括可压缩、可塌缩和/或可压溃的仓体以及嵌入所述仓体内的紧固件,所述紧固件可用于紧固组织。在使用中,所述紧固件仓可被定位在外科紧固装置的第一钳口中,其中所述第一钳口可与第二钳口或砧座相对地定位。所述砧座可与所述紧固件仓接合以压缩、塌缩和/或压溃所述仓体,并且使包含在仓体中的紧固件变形或换句话讲对所述紧固件进行部署。当紧固件变形或被部署时,紧固件可将仓体的至少一部分连同被紧固组织的至少一部分捕获在其中。在各种实施例中,所述仓体可包括由不同材料构成的多个层,所述多个层可对组织施加压力。这些不同的材料可具有不同的刚度和/或弹簧比率。
Description
背景技术
技术领域
本发明涉及一种外科器械,并且在各种实施例中,本发明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。
背景技术
内窥镜式外科器械常常优于传统的开放式外科器件,因为较小的切口往往会降低术后恢复时间和并发症。因此,已对适用于将端部执行器穿过套管针的套管精确地设置在所需外科手术部位处的内窥镜式外科器械进行了显著的开发。这些远侧端部执行器以多种方式接合组织以实现诊断或治疗效果(例如腔内切割缝合器、抓紧器、切割器、缝合器、施夹器、进入装置、药物/基因治疗递送装置以及利用超声波、RF、激光等的能量装置)。
在许多内窥镜式外科应用中,希望采用仅具有完成特定外科手术所需大小的端部执行器。端部执行器越小,手术部位的可视化就越好。较小的端部执行器也能够在紧密空间中更顺利地进入及操纵。这种端部执行器的设计者在试图开发小的端部执行器时面临许多挑战。制造小的端部执行器并且更具体地讲制造被设计成用于切割和缝合组织的小的腔内切割缝合器的能力受到致动力大小的限制,所述致动力通常是使成行的缝钉成形所必需的。这种致动力也可随着被处理的组织的厚度及组成而改变。例如,切割及缝合厚的组织通常需要更大的致动力。然而,切割及缝合较薄的组织期望的致动力较小。因此,许多现有的腔内切割缝合器通常采用强健的砧座闭合系统及缝钉驱动系统,所述砧座闭合系统及所述缝钉驱动系统能够适应特定范围的组织厚度。然而,这种装置常常并不适用于处理较薄的组织。
先前的腔内切割缝合器装置通常也在缝钉被驱动并在切口每一侧上的组织中成形时切割组织。尽管这种装置对于需要切割并紧固组织的手术而言非常有效,然而其无法令外科医生在不切割组织的情况下安装紧固件。同样,尽管已开发出各种形式的铰接式腔内切割缝合器来改善进入,然而这种装置中所通常采用的元件必须基本上足够容纳可从装置的柄部产生并传送足够的击发及闭合力至端部执行器的结构。因此,这种端部执行器常常过大而无法有效进入体内的紧密空间。
因此,需要提供能够解决上述许多挑战的外科切割和缝合器械和钉仓装置。
上述讨论仅仅为了举例说明本技术领域内目前存在的一些不足之处,而不应看作是对权利要求范围的否定。
发明内容
在至少一种形式中,一种钉仓可包括多个缝钉、以及可植入的钉仓本体,所述可植入的钉仓本体包括:由第一材料构成的第一可压缩层,其中缝钉被嵌入所述第一可压缩层中;以及由第二材料构成的第二可压缩层,其中所述第一可压缩层包含第一刚度,其中所述第二可压缩层包含第二刚度,并且其中所述第一刚度不同于所述第二刚度。
在至少一种形式中,一种紧固件仓可包括多个紧固件以及可植入的仓体,所述可植入的仓体包括:由第一材料构成的第一可压缩层合物,其中缝钉被嵌入所述第一可压缩层合物中;以及由第二材料构成的第二可压缩层合物,其中所述第一可压缩层合物包含第一刚度,其中所述第二可压缩层合物包含第二刚度,并且其中所述第一刚度不同于所述第二刚度。
在至少一种形式中,一种紧固件仓可包括多个紧固件以及可植入的仓体,所述可植入的仓体包括用于存储所述多个紧固件的装置以及可压缩层,其中所述装置包含第一刚度,其中所述可压缩层包含第二刚度,并且其中所述第一刚度不同于所述第二刚度。
附图说明
通过结合附图参考本发明实施例的以下说明,本发明的上述和其它特征和优点和其实现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是本发明的外科器械实施例的剖视图;
图1A是本发明的可植入钉仓的一个实施例的透视图;
图1B-1E示出本发明各种实施例的端部执行器的用于夹紧和缝合组织的部分以及本发明的可植入钉仓实施例;
图2是本发明的端部执行器实施例和外科缝合器械实施例的一部分的分解组装剖视图;
图3是本发明的砧座实施例的侧正视图;
图4是图1所示柄部组件的一部分的剖视图;
图5是沿图1中的线5-5截取的图1所示柄部组件的局部剖视图;
图6是本发明的击发传递实施例的一部分的透视图;
图7是沿图1中的线7-7截取的图1所示柄部组件的局部剖视图;
图8是沿图7中的线8-8截取的图7所示柄部组件的一部分的局部剖视图;
图9是本发明的外科器械实施例在端部执行器已联接到外科器械的脊部之后且在所述端部执行器被锁定至所述脊部之前的剖视图;
图9A是图10所示的端部执行器与外科器械的一部分的放大视图;
图10是图9所示外科器械在端部执行器已被锁定至外科器械的脊部之后的剖视图;
图10A是图10所示的端部执行器与外科器械的一部分的放大视图;
图11是图9和图10所示的外科器械在第一击发衔接子已被推进至砧座的夹紧滑道部的起点之后的剖视图;
图11A是图11所示的端部执行器与外科器械的一部分的放大视图,其中其砧座与钉仓之间容纳有组织;
图12是图9至图11所示的外科器械在第一击发衔接子已在砧座的夹紧滑道部上推进之后的剖视图;
图12A是图12所示的端部执行器与外科器械的一部分的放大视图;
图13是图9至图12所示的外科器械在第一击发衔接子已在缝钉成形滑道上推进从而在可植入钉仓内使缝钉完全成形之后的剖视图;
图13A是图13所示的端部执行器与外科器械的一部分的放大视图;
图14是图9至图13所示的外科器械在第一击发衔接子已在缝钉成形滑道上推进从而在可植入钉仓内使缝钉完全成形之后以及在刀杆沿纵向推进穿过端部执行器之后的剖视图;
图14A是图14所示的端部执行器与外科器械的一部分的放大视图;
图15是本发明的另一端部执行器实施例与本发明外科器械实施例的脊构件的一部分的分解剖视图;
图16是图15所示的端部执行器实施例处于打开位置并附接到外科器械实施例的局部剖视图;
图17是图15和图16所示的端部执行器实施例处于完全夹紧位置的另一局部剖视图;
图18是图15至图17所示的端部执行器实施例处于完全击发位置且在远端刀具构件推进之前的另一局部剖视图;
图19是图15至图18所示的端部执行器实施例处于完全击发位置且在远端刀具构件完全推进之后的另一局部剖视图;
图20是本发明的另一柄部组件实施例的一部分的剖视图;
图21是沿图20中的线21-21截取的图20所示柄部组件的一部分的局部剖视图;
图22是沿图20中的线22-22截取的图20所示柄部组件的一部分的局部剖视图;
图23是沿图20中的线23-23截取的图20所示柄部组件的一部分的局部剖视图;
图24是本发明的另一柄部组件实施例的一部分的剖视图;
图25是本发明的另一端部执行器实施例联接到本发明外科器械实施例的一部分的局部剖面侧视图,其中端部执行器支撑本发明的外科钉仓实施例,并且端部执行器的砧座处于打开位置;
图26是图25所示的端部执行器处于闭合位置的另一局部剖面侧视图;
图27是图25和图26所示的端部执行器在刀杆开始穿过端部执行器而被推进时的另一局部剖面侧视图;
图28是图25至图27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剖面侧视图;
图29是本发明的另一端部执行器实施例联接到本发明外科器械实施例的一部分的局部剖面侧视图,其中端部执行器支撑本发明的另一外科钉仓实施例,并且端部执行器的砧座处于打开位置;
图30是图29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剖面侧视图;
图31是本发明的另一外科器械实施例的剖视图,其端部执行器的砧座处于打开位置;
图32是图31所示的端部执行器实施例和外科缝合器械实施例的一部分的分解组装剖视图;
图33是图31所示的端部执行器和外科器械的细长轴组件的一部分的俯视图,其中某些部分显示于沿线图31中的33-33截取的横截面中;
图34是图31所示外科器械的端部执行器和细长轴组件的一部分的俯视图,其中某些部分显示于横截面中;
图35是图31所示外科器械的端部执行器和细长轴组件的一部分的另一俯视图,其中端部执行器处于铰接式取向且端部执行器处于打开位置;
图36是图35所示端部执行器的另一俯视图,其中端部执行器处于闭合或夹紧位置;
图37是图36所示端部执行器和外科器械实施例的一部分的放大视图;
图38是图31所示外科器械的柄部组件的一部分的剖视图;
图39是沿图38中的线39-39截取的图38所示柄部组件的一部分的另一剖视图;
图40是本发明各实施例的关节球和承窝结构的局部分解透视图;
图41是本发明的处于非铰接式取向的另一外科器械实施例的端部执行器和细长轴组件的一部分的俯视图;
图42是图41所示端部执行器和细长轴组件的部分处于铰接位置时的另一俯视图;
图43是本发明另一外科器械实施例的剖视图;
图44是图43所示外科器械实施例的铰接式轴组件的一部分的局部剖视图;
图44A是图44所示铰接式轴组件的一部分的剖视图;
图44B是图44所示铰接式轴组件的另一部分的另一剖视图;
图44C是图44所示铰接式轴组件的另一部分的另一剖视图;
图44D是图44所示铰接式轴组件的另一部分的另一剖视图;
图44E是图44所示铰接式轴组件的另一部分的另一剖视图;
图44F是图44所示铰接式轴组件的另一部分的另一剖视图;
图45是沿图44中的线45-45截取的图44所示铰接式轴组件的局部剖视图;
图46是沿图44中的线46-46截取的图44所示铰接式轴组件的局部剖视图;
图47是图43所示外科器械的另一剖视图,其中所述外科器械的端部执行器显示于完全铰接位置中;
图48是图47所示端部执行器的剖视图,其中波纹管状覆盖件延伸越过铰接接头;
图49是本发明另一外科器械实施例的柄部组件的剖视图;
图50是图49所示端部执行器与细长轴组件的远端的分解组装剖视图;
图51是图50所示端部执行器和细长轴组件的部分的另一剖视图,其中端部执行器处于打开位置;
图52是端部执行器和细长轴组件的部分的另一剖视图,其中端部执行器处于闭合位置;
图53是图49至图52所示端部执行器和细长轴的另一剖视图,其中刀构件处于完全击发位置;
图54是图51至图53所示的端部执行器处于打开位置的透视图;
图55是沿图51中的线55-55截取的图51至图54所示端部执行器的剖视图;
图56是本发明另一实施例的细长轴组件的局部透视图,所述细长轴组件附接到本发明的端部执行器实施例;
图57是本发明另一外科器械实施例的柄部组件的局部剖视图;
图58是沿图57中的线58-58截取的图56和图57所示细长轴组件的一部分的剖视图;
图59是图57所示柄部组件的一部分的放大视图;
图60是图56至图59所示细长轴组件的远端部分的剖视图;
图61是本发明另一实施例的细长轴组件的局部透视图,所述细长轴组件附接到本发明的端部执行器实施例;
图62是图61所示细长轴的可重构的轴区段的一部分的剖视图;
图63是本发明另一实施例的细长轴组件的局部透视图,所述细长轴组件附接到本发明的端部执行器实施例;
图64是本发明另一外科器械实施例的柄部组件的剖视图;
图65是沿图64中的线65-65截取的图63和图64所示细长轴组件的一部分的剖视图;
图66是图64所示柄部组件的一部分的放大视图;
图67是图63所示可重构的轴区段的一部分的剖视图,其中所述部分的各管状链节部基本上沿直线对齐;
图68是图63和图67所示可重构的轴区段的一部分的剖视图,其中所述部分的各管状链节部以基本上弯曲(非同轴)的取向对齐;
图69是本发明的替代钉仓实施例的透视图,所述钉仓安装在本发明的外科切割和缝合装置实施例中;
图70是图69所示装置的外科钉仓和细长通道的俯视图;
图71是本发明的另一外科钉仓实施例的俯视图,所述外科钉仓安装在本发明的端部执行器实施例的细长通道中;
图72是本发明的砧座实施例的仰视图;
图73是用于形成本发明缝钉线实施例的一部分的多个缝钉的局部透视图;
图74是图73所示缝钉线实施例在其缝钉通过与外科切割和缝合装置的砧座相接触而成形后的另一局部透视图;
图75是用于形成本发明另一缝钉线实施例的一部分的替代缝钉的局部透视图;
图76是用于形成本发明另一缝钉线实施例的一部分的替代缝钉的局部透视图;
图77是用于形成本发明另一缝钉线实施例的一部分的替代缝钉的局部透视图;
图78是本发明的端部执行器实施例的剖视图,所述端部执行器实施例支撑本发明的钉仓实施例;
图79是图78所示端部执行器的细长通道部在移除可植入钉仓本体部和缝钉之后的剖视图;
图80是本发明的端部执行器实施例的剖视图,所述端部执行器支撑本发明的另一钉仓实施例;
图81是本发明的外科缝合器械实施例的局部剖视图,其中在所述外科缝合器械的端部执行器中支撑钉仓,以使钉仓锁定系统运动至解锁位置;
图82是图81所示外科缝合器械的另一局部剖视图,其中钉仓自端部执行器移除且钉仓锁定系统处于锁定位置;
图83A-83D根据至少一个实施例描绘位于可塌缩钉仓本体内的外科缝钉的变形;
图84A是示出位于可压溃钉仓本体中的缝钉的图;
图84B是示出图84A所示的可压溃钉仓本体被砧座压溃的图;
图84C是示出图84A所示的可压溃钉仓本体被砧座进一步压溃的图;
图84D是示出图84A所示的缝钉处于完全成形构型且图84A所示的可压溃钉仓处于完全压溃状态的图;
图85是绘示抵靠钉仓支撑表面而定位的缝钉和示出缝钉与钉仓支撑表面之间的潜在相对运动的图;
图86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,以用于稳定图85所示的缝钉;
图87是根据至少一个可供选择的实施例的缝钉的剖视图,所述缝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88是根据至少一个实施例的钉仓的俯视图,所述钉仓包括嵌入可塌缩钉仓本体中的缝钉;
图89是图88所示钉仓的正视图;
图90是根据至少一个实施例的钉仓的正视图,所述钉仓包括围绕位于可塌缩钉仓本体内的缝钉的保护层;
图91是沿图90中的线91-91截取的图90所示钉仓的剖视图;
图92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本体外的缝钉和围绕所述钉仓本体的保护层;
图93是沿图92中的线93-93截取的图92所示钉仓的剖视图;
图94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本体中的缝钉,所述缝钉至少部分地位于所述钉仓本体中的缝钉腔隙中;
图95是沿图94中的线95-95截取的图94所示钉仓的剖视图;
图96是根据至少一个实施例的钉仓的局部切除视图;
图97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本体内的缝钉以及连接所述缝钉并使所述缝钉相对于彼此对齐的对齐矩阵;
图98是沿图97中的线98-98截取的图97所示钉仓的剖视图;
图99是可压缩钉仓本体的内层的局部切除视图;
图100是示出图99所示的内层被压缩于转移板与支撑板之间的图;
图101是示出缝钉被插入图100所示的经压缩的内层中的图;
图102是示出图100所示支撑板被自内层移除的图;
图103是示出包括图99所示内层和被插入外层中的图101所示缝钉的子组件的图;
图104是示出图103所示外层被密封以形成密封钉仓的图;
图105是图104所示密封钉仓的剖视图;
图106是根据至少一个实施例的钉仓和钉仓通道的剖视图;
图107是示出图106所示钉仓的一部分处于变形状态的图;
图108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位于钉仓通道内的钉仓;
图109是图108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110是图108所示端部执行器的正视图,其示出图108所示的钉仓以替代方式位于钉仓通道内;
图111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112是图111所示端部执行器的剖视图,其示出处于闭合位置的砧座;
图113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114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115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以及包括阶梯式仓体的钉仓;
图116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117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118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119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用于支撑钉仓的支撑插入件;
图120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121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122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123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124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125是可压缩钉仓的剖视图,所述可压缩钉仓包括缝钉且其中存储有至少一种药剂;
图126是示出图125所示的可压缩钉仓被压缩且其中所容纳的缝钉变形之后的图;
图127是根据至少一个实施例的钉仓的局部切除视图;
图128是图127所示钉仓的剖视图;
图129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130是图129所示所植入钉仓的剖视图;
图131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132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133是钉仓的可供选择的实施例的剖视图,所述钉仓包括多个缝钉、可压缩层、和脱脂棉层;
图134是图133所示脱脂棉层的透视图;
图135是自图133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缝钉的透视图;
图136是来自图133所示脱脂棉层的两个相连脱脂棉的透视图;
图137是图133所示脱脂棉层的脱脂棉支撑框架被自所分割出的脱脂棉移除的透视图;
图138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缝钉和用于抵靠砧座而驱动缝钉的系统;
图138A是图138所示钉仓的可供选择的实施例的局部切除视图;
图139是图138所示钉仓的剖视图;
图140是能够横贯图138所示的钉仓并使缝钉朝砧座行进的橇的正视图;
图141是示出缝钉驱动器的图,所述缝钉驱动器可由图140所示的橇朝砧座提升;
图142是根据至少一个可供选择的实施例的钉仓的切除视图,所述钉仓包括位于缝钉驱动器内的缝钉;
图143是图142所示的钉仓位于钉仓通道内时的剖视图;
图144是图142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缝钉;
图145是图142所示钉仓的剖视图,其示出朝砧座向上行进的缝钉;
图146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挠性侧的带;
图147是橇和切割构件组件的透视图;
图148是示出使用图147所示的橇和切割构件组件来提升图142所示钉仓的缝钉的图;
图149是示出能够接合缝钉并朝砧座提升缝钉的橇和能够选择性地使橇向远端行进的闭锁系统的图;
图150A-150C示出将缝钉插入缝钉冠部中的过程;
图151是包括支撑盘或保持器的钉仓的剖视图;
图152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153是示出图152所示的钉仓处于植入状态时的图;
图154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155是图154所示钉仓的局部剖视图;
图156是示出图154所示的钉仓处于植入状态时的图;
图157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158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159是图158所示的可塌缩元件处于非塌缩状态时的透视图;
图160是图159所示的可塌缩元件处于塌缩状态时的透视图;
图161A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留矩阵;
图161B是图161A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、被砧座和保留矩阵压缩的钉仓、以及缝钉,所述缝钉至少部分地延伸穿过位于保留矩阵与钉仓之间的组织;
图161C是图161A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161B所示的缝钉接合的保留矩阵;
图161D是图161A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所植入的钉仓和保留矩阵而行进;
图162是根据至少一个可供选择的实施例的保留矩阵的保留孔的透视图,所述保留孔包括多个保留构件,以用于接合延伸穿过所述保留孔的紧固件支腿;
图163是根据至少一个可供选择的实施例的保留矩阵的保留孔的透视图,所述保留孔包括六个保留构件;
图164是根据至少一个可供选择的实施例的保留矩阵的保留孔的透视图,所述保留孔包括八个保留构件;
图165是根据至少一个可供选择的实施例的保留矩阵的保留孔的透视图,所述保留孔包括多个保留构件,以用于接合延伸穿过所述保留孔的紧固件支腿;
图166是根据至少一个可供选择的实施例的保留矩阵的保留孔的透视图,所述保留孔包括六个保留构件;
图167是根据至少一个可供选择的实施例的保留矩阵的保留孔的透视图,所述保留孔包括八个保留构件;
图168是根据至少一个可供选择的实施例的保留矩阵的保留孔的透视图,所述保留孔包括由金属片冲压而成的多个保留构件;
图169是根据至少一个可供选择的实施例的保留矩阵的保留孔的透视图,所述保留矩阵包括沿所述保留孔的周边延伸的多个孔;
图170是根据至少一个可供选择的实施例的保留矩阵的保留孔的俯视图;
图171是根据至少一个可供选择的实施例的保留矩阵的保留孔的俯视图;
图172是根据至少一个可供选择的实施例的保留矩阵的保留孔的俯视图;
图173是根据至少一个可供选择的实施例的保留矩阵的保留孔的俯视图;
图174是根据至少一个可供选择的实施例的保留矩阵的保留孔的俯视图;
图175是根据至少一个实施例的保留矩阵的保留孔的俯视图,所述保留孔包括延伸至所述保留孔中的保留凸片;
图176是根据至少一个可供选择的实施例的保留矩阵的保留孔的俯视图,所述保留孔包括延伸至所述保留孔中的保留凸片;
图177是紧固系统的透视图,所述紧固系统包括多个缝钉、与所述缝钉接合的保留矩阵、以及能够对齐所述缝钉的对齐矩阵;
图178是图177所示保留矩阵的透视图;
图179是图177所示对齐矩阵的透视图;
图180是图177所示的保留矩阵与图177所示的缝钉接合时的局部俯视图;
图181是图177所示的保留矩阵与图177所示的缝钉接合时的局部仰视图;
图182是图177所示紧固系统的局部正视图;
图183是图177所示紧固系统的局部透视图;
图184是图177所示的保留矩阵与图177所示的缝钉接合时的局部剖视图;
图185是图177所示紧固系统的局部剖视图;
图186是图177所示紧固系统的透视图,所述紧固系统还包括组装至缝钉腿的保护性帽;
图187是图186所示紧固系统结构的底部透视图;
图188是图186所示紧固系统结构的局部透视图;
图189是图186所示紧固系统结构的局部剖视图;
图190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、位于钳口中的保留矩阵和多个保护性帽、以及位于钉仓通道中的钉仓;
图191是图190所示的端部执行器处于闭合位置时的正视图;
图192是图190所示的端部执行器处于击发位置时的正视图;
图193是图190所示的保留矩阵和保护性帽组装至图190所示的钉仓时的正视图;
图194是图193所示结构的细部图;
图195是图190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留矩阵与钉仓之间的较薄组织;
图196是图190所示端部执行器的正视图,其示出抵靠图195所示的组织而处于闭合位置的钳口;
图197是图190所示端部执行器的正视图,其示出处于击发位置以在保留矩阵与钉仓之间捕获图195所示较薄组织的钳口;
图198是图190所示保留矩阵和保护性帽组装至图190所示的钉仓并使图195所示的薄组织位于其间时的正视图;
图199是图198所示结构的细部图;
图200是根据至少一个可供选择的实施例的位于缝钉腿顶端上的保护性帽的剖视图;
图201是嵌于材料片内的多个保护性帽的透视图;
图202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性帽容纳于其中;
图203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202所示钳口内的保护性帽的薄片;
图204是根据至少一个可供选择的实施例的位于缝钉腿顶端上的保护性帽的剖视图,其中所述保护性帽包括内部成形表面;
图205是图204所示保护性帽的另一剖视图,其示出抵靠成形表面而变形的缝钉腿;
图206是保留矩阵的可供选择的实施例的俯视图,所述保留矩阵包括多个相连的矩阵元件;
图207是保留矩阵的可供选择的实施例的俯视图,所述保留矩阵包括多个相连的矩阵元件;
图208是保留矩阵的可供选择的实施例的俯视图,所述保留矩阵包括多个相连的矩阵元件;
图209是保留矩阵阵列的可供选择的实施例的俯视图,所述保留矩阵阵列包括多个相连的矩阵元件;
图210是保留矩阵的可供选择的实施例的俯视图,所述保留矩阵包括多个相连的矩阵元件;
图211是包括保留矩阵的钳口的局部分解视图,所述保留矩阵包括可压缩覆盖件;
图212是图211所示保留矩阵的细部图;
图213是包括保留矩阵的紧固系统的局部剖视图,所述保留矩阵包括可压缩层和包封一种或多种药物的多个单元;
图214是示出缝钉腿在与保留矩阵接合时刺穿图213所示单元的图;
图215是包括保留矩阵的紧固系统的局部剖视图,所述保留矩阵包括可压缩层;
图216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217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218是图217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216所示的紧固件仓插入组件;
图219是已加载的图218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之间的组织;
图220是图219所示已加载的端部执行器处于击发构型的正视图;
图221是处于植入状态的第一仓和第二仓的正视图;
图222是图217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223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224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223所示紧固件仓插入组件的正视图;
图225是图224所示已加载端部执行器的剖视图;
图226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227是已移除顶部钳口的图226所示外科缝合器的透视图;
图228是图226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229是图228所示可滑动砧座系统的端视图;
图230是图228所示可滑动砧座系统的俯视图;
图231是示出图228所示的可滑动砧座系统处于未击发状态的图;
图232是示出图228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缝钉处于未部署位置的图;
图233是示出位于底部钳口中的缝钉处于已部署构型且图232所示第一可滑动砧座被拉向近侧以使第一组缝钉的缝钉腿变形的图;
图234是示出图233所示第一组缝钉变形至完全变形状态的图;
图235是示出图228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缝钉腿变形的图;
图236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237是图236所示砧座的横截面端视图;
图238是示出制造图236所示成形凹坑的第一步骤的图;
图239是示出制造图236所示成形凹坑的第二步骤的图;
图240是图236所示砧座的成形凹坑结构的俯视图;
图241是示出用于制造砧座的制造工艺的第一步骤的图;
图242是示出图241所示制造工艺的第二步骤的图;并且
图243是示出图241所示制造工艺的第三步骤的图。
在所述这些图式中,对应的参考符号均表示对应的部件。本文示出的范例以一种形式示出本发明的优选实施例,不应将这种范例理解为是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的美国专利申请,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整体并入本文:
美国专利申请序列号_________,名称为“Surgical Stapling InstrumentWith a Variable Staple Forming System”,代理人案卷号END6848USNP/100533;
美国专利申请序列号_________,名称为“Surgical Stapling InstrumentWith Interchangeable Staple Cartridge Arrangements”,代理人案卷号END6849USNP/100534;
美国专利申请序列号_________,名称为“Surgical Cutting andFastening Instruments With Separate and Distinct Fastener Deployment andTissue Cutting Systems”,代理人案卷号END6839USNP/100524;
美国专利申请序列号_________,名称为“Surgical Stapling InstrumentWith Compact Articulation Control Arrangement”,代理人案卷号END6847USNP/100532;
美国专利申请序列号_________,名称为“Jaw Closure ArrangementsFor Surgical Instruments”,代理人案卷号END6736USNP/100060;
美国专利申请序列号_________,名称为“Surgical Instruments WithReconfigurable Shaft Segments”,代理人案卷号END6734USNP/100058;
美国专利申请序列号_________,名称为“Surgical Staple CartridgesSupporting Non-Linearly Arranged Staples and Surgical Stapling InstrumentsWith Common Staple-Forming Pockets”,代理人案卷号END6735USNP/100059;
美国专利申请序列号_________,名称为“Surgical Staple CartridgesWith Detachable Support Structures and Surgical Stapling Instruments WithSystems For Preventing Actuation Motions When a Cartridge is Not Present”,代理人案卷号END6855USNP/100540;
美国专利申请序列号_________,名称为“Implantable FastenerCartridge Having a Non-Uniform Arrangement”,代理人案卷号END6840USNP/100525;
美国专利申请序列号_________,名称为“Implantable FastenerCartridge Comprising a Support Retainer”,代理人案卷号END6841USNP/100526;
美国专利申请序列号_________,名称为“Selectively OrientableImplantable Fastener Cartridge”,代理人案卷号END6843USNP/100528;
美国专利申请序列号_________,名称为“Implantable FastenerCartridge Comprising Bioabsorbable Layers”,代理人案卷号END6856USNP/100541;
美国专利申请序列号_________,名称为“Compressible FastenerCartridge”,代理人案卷号END6857USNP/100542;
美国专利申请序列号_________,名称为“Fasteners Supported By aFastener Cartridge Support”,代理人案卷号END6858USNP/100543;
美国专利申请序列号_________,名称为“Collapsible FastenerCartridge”,代理人案卷号END6859USNP/100544;
美国专利申请序列号_________,名称为“Fastener System Comprising aPlurality of Connected Retention Matrix Elements”,代理人案卷号END6860USNP/100546;
美国专利申请序列号_________,名称为“Fastener System Comprising aRetention Matrix and an Alignment Matrix”,代理人案卷号END6861USNP/100547;
美国专利申请序列号_________,名称为“Fastener System Comprising aRetention Matrix”,代理人案卷号END6862USNP/100548;
美国专利申请序列号_________,名称为“Fastening Instrument ForDeploying a Fastener System Comprising a Retention Matrix”,代理人案卷号END6863USNP/100549;
美国专利申请序列号_________,名称为“Fastener System Comprising aRetention Matrix and a Cover”,代理人案卷号END6864USNP/100550;以及
美国专利申请序列号_________,名称为“Fastener System Comprising aPlurality of Fastener Cartridges”,代理人案卷号END6865USNP/100551。
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示出于附图中。本领域的普通技术人员将会理解,在本文中具体描述并示出于附图中的装置和方法为非限制性的示例性实施例,并且本发明的多个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,可与其它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“在各种实施例中”、“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结合。因此,在没有限制的情况下,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它实施例的特征、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的临床医生而言的。术语“近侧”是指最靠近临床医生的部分,并且术语“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例如“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,其中在所有视图中,类似的数字代表类似的元件,图1绘示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和图2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14形成端部执行器12的下钳口13。细长通道14能够支撑“可植入的”钉仓30并且还可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例如可由300&400系列17-4&17-7不锈钢、钛等加工而成,并可形成有间隔侧壁16。砧座20例如可由300&400系列17-4&17-7不锈钢、钛等加工而成,并可具有缝钉成形下表面,所述缝钉成形下表面总体被标示为22且其中形成有多个缝钉成形凹坑23。参见图1B-1E。另外,砧座20具有从砧座20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的每一横侧突起,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26可动地或枢转地附接到所述对应狭槽或开口18。
各种形式的可植入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及构造。然而,在图1A和图9-14所示的实施例中示出可植入钉仓30。在至少一个实施例中,钉仓30具有本体部31,本体部31中支撑有多排未成形的金属缝钉32,本体部31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,为了防止缝钉受影响并防止止血材料在引入及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的复合物形成的其它可生物降解的膜,所述膜只有在破裂时才可渗透。钉仓30的本体31的尺寸被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形成接触时,其中的每一缝钉32均与对应的缝钉成形凹坑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便被操纵成将靶组织捕获或夹紧于钉仓30的顶面36与砧座20的缝钉成形表面22之间。缝钉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,以使缝钉成形表面22及更尤其是其中的缝钉成形凹坑23基本上同时接触钉仓30的顶面36。随着砧座20继续运动至钉仓30中,缝钉32的腿部34在砧座20中接触对应的缝钉成形凹坑23,缝钉成形凹坑23用于使缝钉腿34弯曲以使缝钉32成形为“B形”。砧座20朝细长通道14的进一步行进将会进一步压缩缝钉32并使缝钉32成形为所需的最终成形高度“FH”。
上述缝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与可植入钉仓30的顶面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的顶面36之间。图1D示出初始缝钉成形,其中砧座20已开始压缩钉仓30,使得缝钉32的腿部34开始通过砧座20中的缝钉成形凹坑23而成形。图1E示出穿过靶组织“T”而处于最终成形状态的缝钉32,为清晰起见已移除砧座20。一旦缝钉32成形并紧固至靶组织“T”,外科医生便将砧座20运动至打开位置,以在自患者撤出端部执行器12时使仓体31及缝钉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使所有的缝钉同时成形。其余“被压溃的”本体材料31用作止血剂(ORC)及缝钉线加固剂(PGA、PDS、或任何上述其它膜组合物38)。此外,由于缝钉32在成形期间从不需要离开仓体31,因此缝钉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“可植入的”是指除缝钉之外,用于支撑缝钉的仓体材料也将被保持在患者体内并最终被患者身体吸收。这种可植入的钉仓可区别于现有技术中与端部执行器保持在一起并与其一起移除的仓结构。这些“可移除的”钉仓通常包括缝钉驱动器组件,因此其可比本发明的端部执行器大得多,本发明的端部执行器被设计成结合本发明的某些独特且新型的可植入钉仓实施例使用。
在各种具体实施中,端部执行器12能够联接到自柄部组件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及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它横截面形状,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。
在本发明的各种实施例中,细长轴组件40的外径可与处于闭合位置的端部执行器12的外径基本上相同。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的外径可与附接到外轴40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自柄部组件100大体上沿直线向远侧延伸,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可设置为其它长度,并且在其它实施例中,细长轴组件40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它部分进行铰接,以下将更详细地论述之。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留凸耳17,该一对保留凸耳17的尺寸被设定成被容纳在对应的凸耳开口或支架52中,所述凸耳开口或支架52设置于脊构件50的远端中,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便于组装。例如,如图所示的柄部组件100包括右手壳体构件102和左手壳体构件104(图5、7和8),所述右手壳体构件和左手壳体构件是由聚合物或塑性材料模制而成或换句话讲加工而成,并被设计成彼此配合在一起。这种壳体构件102及104可通过在其中模制而成的或换句话讲形成的按扣结构、钉和承窝和/或通过粘合剂、螺钉而附接到一起。脊构件50具有近端54,在该近端上形成有凸缘56。凸缘56能够被旋转地支撑在沟槽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°路径绕纵向轴线A-A旋转。
如在图1和图4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72的尺寸被设定成将安装轴衬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,向内突起的保留凸缘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或其它偏置结构保持于打开位置,如图1、图9A、图10A、和图11A所示。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,所述击发系统被总体上标记为109。击发系统109包括“击发构件”110,在各种实施例中,“击发构件”110包括中空击发管110。中空击发管110可在脊构件50上轴向地运动,因此形成细长轴组件40的外部。击发管110可由聚合物或其它适宜的材料加工而成,并具有附接到击发系统109的击发轭114的近端112。参见图4。在各种实施例中,例如击发轭114可被重叠注塑至击发管110的近端112。然而,也可采用其它紧固件结构。
如在图1和图4中可看出,击发轭114可以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内轴向地运动。在各种实施例中,支撑衬圈120具有一对侧向延伸的翅片122,所述一对翅片的尺寸设定成被可滑动地容纳在翅片狭槽103及105中,所述翅片狭槽103和105分别形成于左手壳体构件102及右手壳体构件104中。参见图7。因此,支撑衬圈120可在柄部壳体100中轴向地滑动,同时使击发轭114及击发管110能够相对于支撑衬圈120而围绕纵向轴线A-A旋转。如在图4中可看出,穿过击发管110设置有纵向狭槽111,以使脊销66能够穿过纵向狭槽111延伸至脊构件50中,同时有利于击发管110在脊构件50上轴向地行进。
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。击发管110的此种沿远侧方向运动至与砧座20进行击发相互作用的轴向运动在本文中被称为“击发运动”。如在图1中可看出,击发触发器130通过枢轴销132而可动地或枢转地联接到柄部组件100。采用扭转弹簧135来偏置击发触发器130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和图4中可看出,击发触发器130具有上部134,该上部可动地附接(销接)到击发链节136,该击发链节可动地附接(销接)到支撑衬圈120。因此,击发触发器130从起始位置(图1和图9)朝与柄部组件100的手枪式握把部107相邻的结束位置(图14)的运动将使击发轭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可植入钉仓一起使用。例如,当与第一击发衔接子140结合使用时,外科器械10可与用于支撑可植入钉仓30的大约20mm长(或具有其它长度)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,如以下所更详细地论述,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150而将外科器械10与其它尺寸的端部执行器及钉仓结合使用。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。在此类实施例中,例如压力表面146或158(通常分别设置于击发衔接子140、150上)将整体地形成于击发管110的远端中—根据与其一起使用的端部执行器的特定尺寸而定。
如在图2中可看出,第一击发衔接子140是基本上中空的并具有第一弹簧部142,该第一弹簧部能够延伸至击发管110的开口的远端116中。第一保持器按钮144形成于第一弹簧部142上,并且其尺寸设定成被容纳在保留孔117中,该保留孔设置在击发管110的远端部分中。参见图1和图2。因此,为从击发管110上拆卸第一击发衔接子140,使用者仅需压下保持器按钮144使其离开保留孔117并将第一击发衔接子140撤出击发管110。在图2中也可看出,第一击发衔接子140具有内部压力表面146,该内部压力表面能够与砧座20的分为两部分的滑道组件24交接。
在各种具体实施中,砧座20上的分为两部分的滑道组件24包括一对尖齿45,所述一对尖齿被刀片容纳沟槽(未示出)间隔开。每一尖齿45均具有近侧表面27,当砧座20处于闭合位置时,近侧表面27基本上平行于细长通道14的底部。随后,近侧表面27过渡至远离近侧表面27的夹紧滑道28。参见图3。夹紧滑道28被取向成相对于近侧表面27成夹紧角“A”。在各种实施例中,例如夹紧角“A”可为大约15度至30度。如以下所更详细地论述,当第一击发衔接子140的第一压力表面146接触夹紧滑道28时,砧座20将朝细长通道14运动,更具体地讲,朝细长通道14中的钉仓30运动。随着第一击发衔接子140进一步向远侧运动,第一压力表面146接触每一砧座尖齿45上的缝钉成形滑道29,以将砧座20进一步驱动至钉仓30中,从而使钉仓30中的缝钉32成形。同样如图3所示,缝钉成形滑道29相对于夹紧滑道27以成形角“B”取向。在各种实施例中,例如成形角“B”可为大约5度至20度。砧座20的滑道组件24上还可具有倾斜的下表面25(例如角“C”为大约5至40度),使得当砧座20处于打开位置时,倾斜的下表面25的表面使砧座20能够枢转至15度的打开极限(图11A中的角“β”)。
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上的保留凸耳17插入脊构件50中的凸耳支架52中来开始联接过程。随后,外科医生朝壳体组件100的手枪式握把107行进击发触发器130,以使击发管110和第一击发衔接子140向远侧推进超过细长通道14的近端部分47,从而将凸耳17保持在其各自的支架52中。参见图10和图10A。第一击发衔接子140相对于凸耳17的此种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160,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。
更具体地讲,参照图5、图7、和图8,端部执行器锁定组件160的一个实施例包括保留销162,该保留销被可动地支撑在击发触发器130的上部134中。保留弹簧166将保留销162朝左手壳体构件104进行弹簧偏置。当击发触发器130处于非致动(起始)位置时,保留销162被偏置至与起始棘爪163进行邻接接触,该起始棘爪从左手壳体构件104向内突起。参见图7和图8。如上所述,击发管110必须首先向远侧推进至联接位置,在联接位置中,第一击发衔接子140将端部执行器12的保留凸耳17保持在脊构件50中的凸耳支架52中。外科医生通过自起始位置朝手枪式握把107牵拉击发触发器130而使击发衔接子140向远侧推进至联接位置。当击发触发器130被开始致动时,保留销162在与起始棘爪163进行邻接接触的同时进行滑动,直至击发管110使第一击发衔接子140推进至联接位置为止,此时保留销162被偏置到形成于左手壳体构件104中的锁定腔164中。参见图8。在各种实施例中,当保留销162进入锁定腔164中时,销162可发出可听见的“咔嗒”声或其它声音,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,只要不有意地将保留销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中的缝钉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,则保留销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。
在各种具体实施中,击发触发器释放按钮167安装在柄部组件100的左侧壳体构件104中,以使外科医生能够有意地释放保留销162,从而使击发触发器130能够被进一步致动或返回至起始位置。参见图5、图7、和图8。击发触发器释放按钮167被可动地安装在锁定腔164中并被弹簧偏置至非激活位置(图8)。当击发触发器释放按钮167被向内按压时,其会接触保留销162并使保留销162运动出锁定腔163外,以使击发触发器130能够被进一步激活。
如到目前为止所述,外科器械10可用作用于操纵/定位组织的抓紧装置。在触发器130被解锁(通过压下保持释放按钮167)之后,击发触发器130朝手枪式握把部107的进一步运动将使击发衔接子140接触砧座20上的夹紧滑道28。随着第一击发衔接子的压力表面部146滑动到夹紧滑道28上,砧座将在细长通道14中朝钉仓30运动。因此,外科医生可朝钉仓30或远离钉仓30而操纵砧座20,以在其间抓紧及释放组织而不使缝钉成形。
本发明的各种实施例还可包括击发系统锁定按钮137,击发系统锁定按钮137枢转地附接到柄部组件100。参见图1和图4。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和图4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(图11和图12)。如以下将更详细地解释,闩锁138用于在以下时刻接合击发轭114:此时脊构件50上的击发轭114的位置对应于其中第一击发衔接子140的压力表面146将朝远侧向砧座20的夹紧滑道28推进的点。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,使得缝钉成形表面部22基本上平行于钉仓30的顶面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而开始缝钉成形过程,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。参见图13。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,从而将第一缝钉衬圈140的压力表面146驱动于对应的缝钉成形滑道29上,以迫使砧座20与钉仓30中的缝钉32进行成形接触。击发系统锁定按钮137防止在外科医生准备好开始缝钉成形过程之前无意地使缝钉32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以开始缝钉成形过程。
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,该组织切割系统被总体上标记为170。在至少一种形式中,组织切割系统170包括刀构件172;可通过致动刀推进触发器200使刀构件172从与端部执行器12的近端相邻的未致动位置(图1和图9-13)选择性地推进至致动位置(图14)。刀构件172被可动地支撑在脊构件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(以C分度表示的洛氏硬度)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31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。参见图14A。如在图4中可看出,刀杆180延伸穿过脊构件50并具有近端部分182。近端部分182以驱动方式与刀传送装置190相互作用,该刀传送装置可操作地附接到刀推进触发器200。在各种实施例中,刀推进触发器200附接到枢轴销132,使得刀推进触发器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,使得刀推进触发器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,以将刀推进触发器200偏置到起始位置或未致动位置。参见图1和图4。
参见图5和图6,刀传送装置190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193上并与第一刀齿轮192啮接。第二刀齿轮194与第三刀齿轮196啮接,该第三刀齿轮被支撑在第三齿轮轴195上。第四刀齿轮198也被支撑在第三齿轮轴195上。第四刀齿轮198能够以驱动方式接合位于刀杆180的近端上的一系列环形齿轮齿或环184。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牵拉刀推进触发器200而使击发杆180轴向地推进且最终向远侧推动刀构件172。
本发明的各种实施例还包括刀锁定系统210,刀锁定系统210防止刀构件72的推进,除非击发触发器130已被拉动至完全击发位置(图13和图14)。因此,这种结构将防止刀推进系统170的激活,除非缝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211被枢转地支撑在柄部组件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相接合,从而防止刀推进触发器200的致动,除非击发触发器130处于完全击发位置。参见图9。
现在将结合图9、9A、10、10A、11、11A、12、12A、13、13A、14、和14A来解释用于操作本发明的至少一个外科器械实施例的各种方法。结合图1、图9、和图9A可理解,当刀杆172处于所示的“起始”位置或未致动位置时,组织切割刀刃176邻近第一击发衔接子140的远端,使得锋利的组织切割刀刃176不会暴露于使用者。在细长轴组件被制造成与单一形式或尺寸的端部执行器一起使用(例如其中未采用击发衔接子140、150)的可供选择的实施例中,刀杆172的切割刀刃176将邻近击发管的远端定位,以同样在这些实施例中防止组织切割刀刃176暴露于使用者。
图9和9A示出通过将端部执行器12上的保留凸耳17插入脊构件50中的凸耳支架52中而被附接到脊构件50之后的端部执行器12。如图9所示,击发触发器130处于未致动位置或起始位置,并且端部执行器12尚未被第一击发衔接子140锁定至脊构件50。“PO”表示在第一击发衔接子140开始向砧座20的夹紧滑道部28上行进之前击发触发器130可行进的距离。刀推进触发器200也处于锁定的未致动位置。
图10及图10A示出击发触发器130在被推进至其中端部执行器12被第一击发衔接子140锁定至脊构件50的位置之后的位置。这种位置在本文中被称为“联接”位置。当处于联接位置时,保留销162已被按扣至锁定腔164(图8)中,从而为外科医生提供端部执行器12现在已被锁定至脊构件50的听觉及触觉指示。直到外科医生有意地压下击发触发器释放按钮167(图5、图7和图8)以将保留销62偏置出锁定腔164外,击发触发器130才能被进一步致动。第一击发衔接子140的远端141已行进的距离被表示为距离“l”(图10A),并且击发轭114在脊构件50上已行进的对应距离被表示为距离“l’”。图11及图11A示出在释放按钮(未示出)被压下且外科医生已激活击发触发器130以将第一击发衔接子140运动至砧座20上的夹紧滑道28的起点之后击发触发器130的位置。如在这些图中可看出,砧座弹簧21已将砧座20偏置到打开位置。第一击发衔接子140的远端的行进被表示为距离“l1”,并且击发轭114在脊构件50上已行进的对应距离被表示为距离“l’1”。图12及图12A示出第一击发衔接子140在被推进至砧座20的缝钉成形滑道29的起点之后的位置。此位置表示在缝钉成形开始之前可获得的最大夹紧量。此位置在本文中被称为“最大夹紧位置”。如在图12中可看出,击发轭114已接触击发触发器释放按钮137上的闩锁138,因此直到击发触发器释放按钮137被压下时,击发轭114才能被进一步向远侧推进。如在图12A中可看出,砧座20的缝钉成形表面22基本上平行于钉仓30的顶面31。砧座20的缝钉成形部22与细长通道14的顶部保持表面之间的距离被表示为“Cmax”。在各种实施例中,对于具有基本上相等厚度的本体部31的各钉仓30而言,Cmax可例如为0.085英寸至0.144英寸(大约2.15mm至3.65mm)。在至少一个实施例中,例如仓厚度可大于缝钉尺寸大约0.01英寸至0.03英寸(大约0.25mm至0.76mm)。第一击发衔接子140从起始位置到此最大夹紧位置所行进的总距离被表示为“l2”,并且击发轭114在脊构件50上已行进的对应距离被表示为“l’2”。图13及图13A示出击发轭114处于完全击发位置时的位置,在完全击发位置中,钉仓30中的缝钉32被完全成形。当处于该位置时,砧座20的缝钉成形部22与细长通道14的顶部保持表面之间的距离被表示为“Cmin”。在各种实施例中,对于用于支撑未成形时腿部为大约0.075英寸至0.134英寸(大约1.90mm至3.40mm)长(图1A中的距离“UF”)且完全成形时的完全成型高度例如为大约0.025英寸至0.04英寸(大约0.63mm至1.01mm)(包括图1D中的距离“FF”)的缝钉的钉仓而言,“Cmin”可为例如大约0.015英寸至0.030英寸(大约0.38mm至0.76mm)。第一击发衔接子140从起始位置到此完全击发位置所行进的总距离被表示为“l3”,并且击发轭114在脊构件50上已行进的对应距离被表示为“l’3”。同样在图13中可看出,击发触发器130处于完全击发位置并已接触刀锁定杆211的激活端212,以偏置保持吊钩214而使其与第一切割齿轮192上的闩锁杆216脱离。
横切,尤其是血管的横切可为任何外科手术中难度最大的步骤之一。在腹腔镜式环境中,横切的难度更大,这是因为如果出现任何失败,则整个手术可能需要几乎立即转换成开放式手术,以防止发生灾难性事件。因此,期望采用一种能够在部署缝钉之后任选地切割组织的外科缝合器械。本发明的各种实施例能够满足这种需求。
在缝钉被“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而留下可植入的钉仓30和缝钉32。在其中端部执行器穿过通道、工作通道等而被插入的应用中,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缝钉之后切割靶组织,则外科医生以上述方式激活刀推进触发器200,以驱动刀杆72穿过靶组织而到达端部执行器的末端,如图14、14A所示。图14示出在针对不同长度的端部执行器/钉仓的各种实施例中刀推进触发器200的运动量,其中刀杆72已推进至端部执行器12中的完全击发位置。随后,外科医生可释放刀推进触发器200,以使击发返回弹簧202能够使击发传送装置将刀杆72返回至起始(非致动)位置(图13、13A)。一旦刀杆72返回至起始位置,外科医生便可打开端部执行器钳口13、15,以将可植入的仓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,本发明的这种外科器械有利于使用可通过相对较小的工作通道及通道而被插入的小的可植入钉仓,同时为外科医生提供击发缝钉而不切割组织或视需要在击发缝钉之后也切割组织的选择。
如上所述,外科器械10可与支持其它尺寸的钉仓的其它端部执行器结合使用,所述其它尺寸的钉仓容纳有其它尺寸及数目的缝钉。图15-19示出端部执行器12’的使用,端部执行器12’可操作地支撑钉仓30’,该钉仓所具有的缝钉32’大于钉仓30中的缝钉32。例如,钉仓30中的缝钉32可为大约0.080英寸至0.085英寸(大约2.03mm至2.15mm)的缝钉,而钉仓30’中的缝钉32’可为大约0.075英寸(大约1.90mm)。在各种实施例中,钉仓30’长于钉仓30。例如,钉仓30可为大约0.78英寸(大约20mm)长;而钉仓30’可为大约1.57英寸(大约40mm)长。图15是端部执行器12’、第二击发衔接子150、及脊构件50的远端55的分解视图。如在图15中可看出,细长通道14’具有一对间隔开的侧壁16’,每一侧壁16’中具有狭槽或开口18’,该狭槽或开口的尺寸被设定成容纳对应的砧座销26’。砧座20’与细长通道14’可共同形成端部执行器12’,该端部执行器的总直径将容许端部执行器12’穿过具有至少大约0.20英寸(大约5.0mm)直径的开口。砧座20’也具有缝钉成形部22’及分为两部分的滑道组件24’,所述缝钉成形部22’中形成有多个缝钉成形凹坑,并且分为两部分的滑道组件24’从砧座20’朝近侧突起。细长通道14’的近端15’具有从其突起的一对保留凸耳17’,该一对保留凸耳的尺寸设定成被容纳在脊构件50中所设置的对应的凸耳支架52中。
如在图15中可看出,第二击发衔接子150具有基本上中空的本体部151以及近侧衬圈部152,近侧衬圈部152中具有向内延伸的保持突起154。本体部151与近侧衬圈部152之间设置有狭槽156,以使衬圈部152能够相对于本体部151被偏置,以利于将保持突起154插入击发管110中的保留孔117中。为从击发管110上拆卸第二击发衔接子150,外科医生需压下近侧衬圈部152以将保持突起154移出保留孔117外,从而使第二击发衔接子150能够朝远侧被拉离击发管110。
在各种实施例中,砧座20’具有分为两部分的滑道组件24’,分为两部分的滑道组件24’具有一对尖齿45’,所述一对尖齿45’中的每一者均具有近侧表面27’,近侧表面27’过渡至远离近侧表面27’的夹紧滑道28’。参见图15。夹紧滑道28’被取向成相对于近侧表面27’成角度“A’”。在各种实施例中,例如角度“A’”可为大约50至30度。如以下所更详细地论述,当第二击发衔接子150的第二压力表面158接触夹紧滑道28’时,砧座20’将朝细长通道14’运动,更具体地讲,朝细长通道14中的钉仓30’运动。参见图17。当第二击发衔接子150进一步向远侧运动时,第二压力表面158接触砧座尖齿45上的缝钉成形滑道29’,以进一步朝钉仓30’驱动砧座20’,从而使钉仓30中的缝钉32成形。参见图18。缝钉成形滑道29’被取向成相对于夹紧滑道27’成角度“B’”。在各种实施例中,例如角度“B’”可为大约5至20度。滑道组件24’与细长通道14’的底部之间可设置有弹簧(未示出),以将砧座20’偏置到打开位置。
图16示出在外科医生已将第二击发衔接子150朝远侧推进至夹紧滑道部28’的起点之后第二击发衔接子150的位置。击发触发器130以上文中关于第一击发衔接子140所述的方式来控制第二击发衔接子150的操作。图17示出第二击发衔接子150处于完全夹紧位置时的位置。图18示出第二击发衔接子150处于完全击发位置时的位置;在所述完全击发位置中,钉仓30’中的缝钉32’已穿过所夹紧的组织(未示出)而成形。
如上所述,可植入钉仓30’比可植入钉仓30长。因此,如图15所示,端部执行器12’也包括远侧刀构件124,该远侧刀构件被可动地支撑在细长通道14’中。远侧刀构件124具有组织切割刀刃125和近侧部分126,该近侧部分能够由刀杆72进行接合。因此,如果外科医生想要在缝钉已被击发之后切割组织,则外科医生需如上所述激活击发触发器200,以朝远侧驱动刀杆172使其接触远侧刀构件124,从而驱动远侧刀构件124穿过组织,如图19所示。远侧刀构件124上可具有至少一个保持器部,该保持器部能够穿过细长通道14’中的对应成型的狭槽(未示出)而滑动。这种结构使端部执行器12’能够在缝钉成形且组织被切割之后打开。远侧刀构件124保持在砧座20’中并在从患者体内被撤出时与端部执行器12’一起被移除。
因此,外科器械10的各种实施例具有单独的缝合机构和组织切割机构,使得外科医生可在不切割组织的条件下缝合组织。本发明缝合器械的各种实施例可顺利地与能够击发不同尺寸和数目的缝钉的不同尺寸的端部执行器一起使用。外科器械可按包括器械10和第一击发衔接子140和第二击发衔接子150的套件形式来提供,第二击发衔接子150使器械能够用于击发不同尺寸的可植入钉仓。
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被砧座成形接触的缝钉。与现有技术中采用缝钉驱动元件的外科缝合结构不同,本发明各种实施例的钉仓中的缝钉不被驱动至砧座中。在本发明的各种实施例中,砧座被驱动至未成形的缝钉中。所获得的缝钉成形程度取决于砧座被驱动至缝钉中的程度。这种结构使得外科医生能够调整施加至缝钉的成形或击发压力的大小,从而改变缝钉的最终成形高度。
在各种实施例中,施加至可行进砧座的击发运动的量取决于击发触发器的致动程度。例如,如果外科医生想要获得仅部分成形的缝钉,则仅需朝手枪式握把107部分地向内压下击发触发器。要想获得更多的缝钉成形,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缝钉进行成形接触。如本文所用,术语“成形接触”是指缝钉成形表面或缝钉成形凹坑已接触缝钉腿的末端并已开始将腿部成形或弯曲至成形位置。缝钉成形的程度是指缝钉腿被折叠的程度且最终是指上文所提及的缝钉的成形高度。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,所以缝钉基本上同时成形并具有基本上相同的成形高度。
图20-23示出采用缝钉高度指示器组件220的可供选择的外科器械10。在各种实施例中,缝钉高度指示器组件220包括指示器棒222,指示器棒222附接到击发触发器130的上部134,以与上部134一起枢转地行进。当击发触发器130朝柄部组件100的手枪式握把107枢转以如上所述将砧座20压紧至钉仓30中时,可透过左手壳体构件104中的视窗223观察到指示器棒222。在此类实施例中,缝钉高度指示器组件220也包括形成于左手壳体构件104中且对应于缝钉成形的三个阶段的一系列棘爪24、26、28。具体地讲,一旦击发触发器130被初始地致动,保留销162便在与起始棘爪163邻接接触的同时进行滑动,直至击发管110将击发衔接子140或150推进至上述锁定位置为止,此时保留销162被偏置到形成于左手壳体构件104中的锁定腔164中。当外科医生想要开始闭合端部执行器12的钳口13、35时,需压下保持释放按钮167,以使击发触发器130能够被进一步致动。当击发触发器释放按钮167被向内按压时,其会接触保留销162并使保留销162运动出锁定腔163外,以使击发触发器130能够被激活。如上所述,外科医生现在可使用端部执行器12的底部钳口13及顶部钳口15来抓紧并操纵组织。当外科医生想要开始缝钉成形过程时,需将击发触发器释放按钮167压下,从而在外科医生继续压下击发触发器130时使击发轭114能够朝远侧推进。
击发触发器130的进一步推进会使砧座20运动至与钉仓30中的缝钉32进行成形接触。随着击发触发器130被进一步按下,保留销162的平端165将滑动离开起始棘爪163并接触对应于第一缝钉成形量的第一棘爪224,所述第一缝钉成形量由左手壳体构件104上的第一缝钉高度符号230表示。参见图20。如图所示,第一缝钉高度符号230包括缝钉刚开始成形的图片。可使用其它符号/标记来标识缝钉成形的此阶段。当保留销162接合第一棘爪224时,外科医生可听见咔嗒声。保留销162与第一棘爪224的接合也可通过击发触发器130对外科医生提供某种触觉反馈。另外,可透过与第一高度缝钉符号230相邻的观察窗口223观察到缝钉高度指示器棒222。如果外科医生想要使钉仓中的缝钉32进一步成形,则通过形成于第二侧壳体构件104中的释放按钮240来按压保留销162以使其与第一棘爪224脱离。在各种实施例中,例如释放按钮240可利用铰链部242而整体地形成于左手壳体构件104中,铰链部240是左手壳体构件104的一部分。这种结构使释放按钮240能够被按压到保留销162的末端165中,以使末端165运动而与第一棘爪224、第二棘爪226和第三棘爪228中的任一者脱离。一旦保留销162被按压至第一棘爪224外,击发触发器130便可被进一步压下,直至保留销162接合第二缝钉成形棘爪226为止。击发触发器130的这种位置使得砧座20进一步运动,以与钉仓30中的缝钉32进行缝钉成形接触。同样,保留销162按扣至第二缝钉成形棘爪226中,并为外科医生提供击发触发器130处于第二缝钉成形位置的听觉及触觉反馈。当处于该位置时,缝钉高度指示器棒222可透过观察窗口223而被观察到且邻近第二缝钉高度符号232。如果外科医生想要使钉仓30中的缝钉32进一步成形,则通过压下释放按钮240来按压保留销162使其与第二棘爪226脱离。随后,可进一步压下击发触发器130,直至保留销162接合与缝钉成形的最后阶段相对应的第三缝钉成形棘爪228为止。同样,保留销162按扣至第三缝钉成形棘爪228中,并为外科医生提供击发触发器130处于第三缝钉成形位置的听觉及触觉反馈。当处于该位置时,缝钉高度指示器棒222可透过观察窗口223而被观察到且邻近缝钉高度符号234。在缝钉成形为期望的量之后,外科医生可偏置保留销162使其离开第三缝钉高度棘爪228,以使击发触发器130能够返回至起始位置。或者,如果需要,外科医生随后可在将击发触发器130返回至起始位置之前开始上述组织切割手术。
图24示出其中被总体上标识为220’的缝钉高度指示器组件不包括与各种缝钉成形对应的一系列棘爪的可供选择的实施例。然而,此实施例包括缝钉高度指示器棒222和观察窗口223。因此,外科医生可通过透过观察窗口223监视缝钉高度指示器棒222的位置来监视所达到的缝钉成形量。此实施例不包括上述缝钉高度指示器符号230、232和234。另外,此实施例也可包括与起始位置相对应的未成形缝钉符号229,在所述起始位置中,缝钉32尚未开始通过砧座20而成形。另外,此实施例将以与上述相同的方式操作。
图25和26示出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或自刀杆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,在此实施例中,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’及下横切构件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’被取向成横贯端部执行器12”的细长通道14”中的细长狭槽252。砧座20”中也设置有脱离狭槽(未示出),使得当刀杆172’被驱动至端部执行器12”内的结束位置时,上横切构件173’穿过对应的狭槽而下落,以使砧座20”能够运动至打开位置,从而与所缝合和切割的组织脱离。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”被弹簧或其它打开结构(未示出)偏置到完全打开位置(图25)。砧座20”通过击发衔接子150以上述方式进行的轴向行进而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26),外科医生便可随后以上述方式朝远侧推进刀杆172”。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”而运动,如图27中的虚线所示。在此实施例中,当刀杆172”朝远侧运动时,上横切构件173’和下横切构件175’同时拉动砧座20”和细长通道14”,以在刀杆172”穿过端部执行器12”朝远侧推进时达到期望的缝钉成形。参见图28。因此,在此实施例中,缝钉成形是与组织切割同时发生,但缝钉本身可在刀杆172”朝远侧被驱动时依序成形。
图29和30示出具有砧座20”的端部执行器12”的使用,砧座20”例如由不锈钢、钛、PGA(聚乙醇酸)或其它可吸收的塑料加工而成,并且在某种程度上是挠性的。这些图也示出保留矩阵6250及对齐矩阵6206的使用,以下将更详细地说明。如在图29中可看出,当刀杆172”穿过砧座20”朝远侧被驱动时,砧座20”屈曲至完全成形位置。
在许多外科应用中,可取的或有利的是采用如下外科切割和缝合器械,所述外科切割和缝合器械具有可相对于细长轴组件进行铰接的端部执行器。然而,现有技术中的可铰接器械进入紧密区域的能力常常由于用于对端部执行器进行铰接的构件的尺寸及构造而受限。图31-40示出本发明的另一外科器械实施例,所述外科器械能够使端部执行器相对于细长轴进行铰接,并且所述外科器械在柄部组件中采用相对紧凑的铰接控制结构。
此实施例的外科器械310基本上类似于上述各种外科器械实施例10,不同之处在于,此实施例采用铰接式轴组件312,以利于相对于细长的纵向轴线A-A而选择性地定位端部执行器12。尽管本文将描述外科器械310是与上述类型的端部执行器12结合使用,然而本领域中的普通技术人员应理解,外科器械310也可与第二击发衔接子150结合使用以致动端部执行器12’或其它端部执行器结构。如在图31和图32中可看出,铰接式轴组件312包括远侧轴组件部314,该远侧轴组件部枢转地联接到近侧轴组件部316,该近侧轴组件部可操作地联接到柄部组件100。在各种实施例中,例如远侧轴组件314包括远侧脊构件320,该远侧脊构件中具有一对凸耳支架322以用于将凸耳17容纳在其中。参见图32。远侧脊构件320具有近端324,该近端包括枢轴基座326,该枢轴基座具有从其突起的枢轴销328。
如在图32中可看出,近侧轴组件部316包括近侧脊区段330,近侧脊区段330具有近侧枢轴基座和附接到所述近侧枢轴基座的刀导轨332。刀导轨332可例如使用粘合剂或其它紧固件结构而焊接或附接到近侧脊段330。近侧枢轴基座刀导轨332中设置有枢轴孔334以将枢轴销328可旋转地容纳在其中,从而使远侧脊段320能够相对于近侧脊段330绕第一枢轴线FA-FA枢转,所述第一枢轴线FA-FA基本上横切纵向轴线A-A。外科器械310还包括远侧击发管段370,该远侧击发管段枢转地联接到一对击发管链节380、382,以围绕第二轴线SA-SA枢转地行进。远侧击发管段370具有保持器孔372,以用于将第一击发衔接子140的保持器按钮144容纳在其中。所述一对击发管链节380、382枢转地联接到近侧击发管390,以相对于近侧击发管390绕第三枢转轴线TA-TA枢转运动。参见图32。
在各种实施例中,近侧击发管390附接到旋转旋钮400,旋转旋钮400可旋转地附接到柄部组件100。参见图31、图38、和图39。旋转旋钮400可由聚合物或塑性材料模制而成,并可包括中心部402及与中心部402间隔开的凸缘部404。柄部组件100的前缘部分101被容纳在中心部402与凸缘部404之间,以使旋转旋钮400能够相对于柄部组件100绕纵向轴线A-A旋转。在其它实施例中,旋转旋钮400可由其它适宜的材料加工而成。在所示实施例中,近侧击发管390和近侧脊段330分别非可动地附接到旋转旋钮400。如在图38和图39中可看出,近侧脊段330和近侧击发管390通过销406销接至旋转旋钮400。因此,外科医生可通过对旋转旋钮400进行旋转而相对于柄部组件100沿360度路径绕纵向轴线A-A旋转端部执行器12。
参见图37、图38及图40,在各种实施例中,端部执行器12可通过一对铰接构件420、430及铰接球440而相对于纵向轴线A-A选择性地进行铰接,所述一对铰接构件420、430附接到远侧枢轴基座326,并且铰接球440可旋转地支撑在旋转旋钮400中的承窝408内。在各种实施例中,铰接构件420、430例如可包括由多线缆线、镍钛诺、钛等加工成的缆线。第一或右侧铰接构件420具有远端422,该远端上形成有耳状物424,该耳状物的尺寸被设定成能够压配到远侧枢轴基座326中所设置的第一缆线附接孔327中。同样,第二或左侧铰接构件430具有远端432,该远端上形成有耳状物434,该耳状物434的尺寸被设定成能够压配到远侧枢轴基座326中所设置的第二缆线附接孔329中。参见图37。因此,可通过牵拉第一或右侧铰接构件420来使端部执行器12绕第一轴线FA-FA(图35和图36)枢转到右侧,并可通过牵拉第二或左侧铰接构件430来使端部执行器12绕第一轴线FA-FA枢转到左侧。在各种实施例中,右侧铰接构件420可被滑动地容纳于在近侧脊段330中形成的右侧缆线槽336中,并且左侧铰接构件430可被滑动地容纳在近侧脊段330中的左侧缆线槽338中。
参照图38-40,第一铰接构件420具有近端426,近端426上锻造有或换句话讲附接有保持球428,保持球428能够容纳于铰接球440中的第一保留狭槽442内,铰接球440可旋转地支撑在旋转旋钮400中的承窝401内。同样,第二铰接构件430具有近端436,该近端上锻造有或换句话讲附接有保持球438,该保持球能够被容纳在铰接球440中的第二保留狭槽444内。如在图40中可最尤其看出,铰接球440还具有穿过铰接球440的致动器狭槽446,该致动器狭槽有利于在其中为近侧击发管段390形成畅通无阻的通道。如图38所示,致动器狭槽446可从较宽的开口部448、450到铰接球440的中心中的通道452逐渐变细,该通道容许近侧击发管段390以滑动方式通过。如以下所进一步论述,铰接球440可旋转地或被枢转地支撑在承窝401内,并且从中性位置(在图38中以实线示出)选择性地运动至第一铰接控制位置和第二铰接控制位置(在图38中以虚线示出)。铰接球440也在承窝401内轴向地运动。
如在图40中可看出,外科器械310可包括被总体上标识为453的锁定装置,以用于将铰接球440锁定在中性位置、第一铰接控制位置、及第二铰接控制位置中的任一者。在各种实施例中,锁定装置453包括一系列锁定棘爪段454,所述一系列锁定棘爪段454设置于铰接球440上并能够与形成于凹陷部408内的锁定肋410相配合,所述凹陷部形成于中心部402中,所述中心部被取向于旋转旋钮400的承窝区域401中。致动器通道412延伸穿过中心部402并与铰接球440中的致动器狭槽446对齐,以容纳穿过致动器通道412的近侧击发管段390。如在图38和图39中可看出,致动器球弹簧456在旋转旋钮400的弹簧保持中心部414上推进以朝近侧偏置铰接球440,使得锁定棘爪454与中心部402中的锁定肋410以保持方式进行接合。
为利于对铰接球440施加铰接运动,一对横向延伸的铰接柄458、460从铰接球440沿径向相对的方向突起。在各种实施例中,铰接球440可例如由无填充的、玻璃填充的、碳填充的、矿物填充等的聚碳酸酯、尼龙、加工而成,并且铰接球440上可机加工或模制有锁定棘爪454。铰接柄458、460可通过压配合、焊接等方式附接到铰接球440。这种锁定装置使铰接球440能够被锁定至中性位置、或第一铰接位置或第二铰接位置中的任一者。一旦外科医生将铰接球440运动至达到端部执行器期望的铰接位置,外科医生便可释放铰接球440,以使致动器球弹簧456能够朝近侧偏置铰接球440,使得锁定棘爪454与中心部402中的锁定肋410以保持方式接合。在各种实施例中,致动器球弹簧456的尺寸可被设定成当铰接的端部执行器通过套管针或相似的开口而被强制拉回时,铰接球440可弹回至中性位置。此外,铰接柄458、460的使用使得能够根据特定的外科应用来“微调”铰接程度。
如在图38中可看出,第一铰接柄或右侧铰接柄458穿过旋转旋钮400中的右侧狭槽416突起,并且第二铰接柄或左侧铰接柄460穿过旋转旋钮400中的左侧狭槽418突起。为使端部执行器12相对于纵向轴线A-A进行铰接,外科医生需首先沿远侧方向“DD”轴向地运动右侧铰接柄458和左侧铰接柄460,以使锁定棘爪454从旋转旋钮400的中心部402中的锁定肋410脱离。随后,外科医生可通过沿期望方向运动铰接柄458、460以对铰接构件420、430施加铰接运动而使铰接球440进行枢转。例如,可通过以下方式使端部执行器12枢转至右侧:沿近侧方向“PD”运动右侧铰接柄458,并沿远侧方向“DD”运动左侧铰接柄460,以对右侧铰接构件420施加牵拉运动(铰接运动)且对左侧铰接构件430施加推动运动。相似地,可通过以下方式使端部执行器12枢转至左侧:沿近侧方向“PD”运动左侧铰接柄460,并沿远侧方向“DD”运动右侧铰接柄458,以对左侧铰接构件430施加牵拉运动(铰接运动)且对右侧铰接构件420施加推动运动。右侧铰接柄458和左侧铰接柄460的各种运动范围以虚线示于图38中。如此一来,端部执行器12可例如通过顺时针或逆时针调整角度而最佳地定位在各种成角度的位置中,而无需使细长轴组件40进行旋转或其它运动。图35示出角α,在各种实施例中,角α可为0°至45°。
外科器械310的各种实施例包括穿过刀支撑狭槽333并被可动地支撑在中空的近侧脊区段330中的刀杆472,刀支撑狭槽333从窄的近侧部分335到宽的远侧部分337呈锥形,以使刀杆472能够围绕刀支撑狭槽333而屈曲,从而适应端部执行器12绕纵向轴线A-A的铰接。参见图37。在各种实施例中,刀杆472可由例如300或400系列的不锈钢加工而成,并可具有形成于其远端上的组织切割刀刃476。如在图37中可进一步看出,刀杆472可滑动地穿过远侧枢轴基座326中的刀狭槽473。刀杆472的近端478附接到延伸穿过近侧脊段330的刀杆480,从而如上所述以驱动方式接合击发传送装置190。参见图31。保留销406延伸至近侧击发管段390中的纵向狭槽392(图38)中并穿过近侧脊段330中的孔339(图39)而进入刀杆480中的纵向狭槽482中,以使近侧击发管段390及刀杆480能够相对于近侧脊段330及柄部组件100轴向地运动。因此,外科医生可通过以上述方式操作刀推进触发器200来选择性地操作刀杆472以切割组织。
各种铰接结构公开于2010年5月7日提出申请的、授予Frederick E.Shelton IV且名称为“Laparoscopic Devices With Articulating End Effectors”的美国专利申请No.12/775,809(代理人案卷号END6755USNP)及2010年5月7日提出申请的、授予Frederick E.Shelton IV等人且名称为“BendableShaft For Handle Positioning”的美国专利申请No.12/775,699(代理人案卷号END6756USNP)中,上述美国专利申请中的每一者的公开内容相应全文以引用方式并入本文中。图41和图42示出可供选择的铰接式轴组件490,该铰接式轴组件490与铰接式轴组件340基本上相同并以基本上相同的方式进行操作,不同之处在于中间击发管段492取代了铰接式轴组件340中所采用的击发管链节380。如在图41和图42中可看出,中间击发管段492从远侧击发管段370延伸至近侧击发管段390。在各种实施例中,中间击发管段492可由尼龙、或其它挠性塑料加工而成。在各种实施例中,中间击发管段492具有两个纵向延伸的压缩脊部494,由空间498间隔开的多个间隔开的肋段496从压缩脊部494延伸以形成基本上中空的管段,所述脊组件的其它元件及刀杆可操作地穿过所述基本上中空的管段。脊部494能够从近侧击发管段390向远侧击发管段370传递压缩运动,所述压缩运动的大小足以将砧座20致动至完全击发位置,同时使端部执行器12能够相对于纵向轴线A-A选择性地铰接。中间击发管段492具有远端部分491和近侧部分493,所述远端部分491通过例如销、开槽的套筒、按扣结构等附接到远侧击发管段,所述近侧部分493通过相同或相似的装置附接到近侧击发管段390。在此实施例中,端部执行器12可例如通过顺时针或逆时针调整角度而最佳地定位在各种成角度的位置中,而无需使细长轴组件490进行旋转或其它运动。图42示出角度α,在各种实施例中,角度α可为0°至45°。
图43-47示出本发明的另一外科器械实施例。除以下所述各种不同点之外,此实施例的外科器械510基本上类似于上述外科器械实施例310。尽管本文将描述外科器械510是与上述类型的端部执行器12结合使用,然而本领域中的普通技术人员将理解,外科器械也可与第二击发衔接子150结合使用以致动端部执行器12’或可与其它端部执行器结构结合使用。外科器械510的各种实施例包括铰接式轴组件512,以利于相对于纵向轴线A-A选择性地定位端部执行器12。如在图43和图44中可看出,铰接式轴组件512包括远侧脊构件520,该远侧脊构件中具有一对凸耳支架522以用于将凸耳17容纳在其中。远侧脊构件520具有近端521,该近端枢转地联接到近侧脊段530的远端531。具体地讲,远侧脊段520的近端521具有用于支撑铰接销524的一对间隔开的远侧脊尖齿523,所述铰接销524延伸穿过近侧脊段530的远端531,以限定基本上横切纵向轴线A-A的铰接轴线AA-AA。参见图46。
在本发明的各种实施例中,端部执行器12可绕纵向轴线A-A铰接成各种不同的取向。例如,图47中的角度α’可介于180°到90°的范围内。端部执行器12通过至少一个联接到铰接链节540的铰接构件550而进行铰接。铰接链节540通过远侧销542而枢转地联接到远侧脊段520的远端521。参见图43。铰接链节540通过铰接杆销554而枢转地联接到铰接杆550的远端552,如图46所示。如在图43中可看出,铰接构件550延伸穿过铰接式轴组件512并具有近端556,该近端556延伸至旋转旋钮560中,该旋转旋钮560可旋转地联接到柄部组件100。铰接构件550的近端556联接到铰接控制构件或按钮558,所述铰接控制构件或按钮558可滑动地联接到旋转旋钮560以相对于旋转旋钮560进行选择性的轴向行进。因此,沿远侧方向“DD”轴向滑动铰接按钮558将使端部执行器12以图47中所示的方法绕纵向轴线A-A进行枢转。为使端部执行器返回至其中端部执行器以同轴方式对齐于纵向轴线A-A上的起始非铰接位置,外科医生仅需在旋转旋钮560上沿近侧方向“PD”滑动致动器按钮558。
与上述实施例中的某些实施例一样,旋转旋钮560不可旋转地联接到安装轴衬570,安装轴衬570可旋转地附连到柄部组件100。参见图43和图47。安装轴衬570具有近侧凸缘572和远侧凸缘574,该近侧凸缘572和远侧凸缘574之间限定有旋转沟槽575,以将柄部组件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570能够相对于柄部组件100绕纵向轴线A-A旋转。近侧脊段530不可旋转地销接或换句话讲(焊接、利用粘合剂等)附接到安装轴衬570,使得旋转旋钮560绕纵向轴线A-A的旋转能够使端部执行器12绕纵向轴线A-A旋转。应当理解,这种结构可有利于端部执行器12沿360°路径绕纵向轴线A-A旋转。
此实施例也具有远侧击发管区段580,远侧击发管区段580联接到第一击发衔接子140并可在远侧脊段520上轴向地行进。具体地讲,第一击发衔接子140上的保持器按钮144以上述方式被容纳在远侧击发管段580中的保持器孔581内。远侧击发管段580由附接到远侧击发管段580的至少一个击发构件致动。在一个优选的实施例中,远侧击发管段580由附接到远侧击发管段580的一对击发带582、584致动。击发带582、584附接到带底座585,该带底座联接到近侧击发管段590,该近侧击发管段590以上述方式附接到击发轭114。覆盖管592也在近侧脊段530上推进并联接到旋转旋钮560以与旋转旋钮560一起旋转。近侧击发管590及带底座585可相对于覆盖管592轴向地运动。击发带582、584可滑动地容纳在远侧脊构件520中的侧向带通道526内,如图44C所示。在各种实施例中,击发带582、584各自包括可由例如不锈钢加工而成的薄的挠性构件,并且分别能够推动远侧击发管段580,从而以上述方式致动或闭合砧座20以使可植入钉仓30中的缝钉32成形。通过以上述方式牵拉击发触发器130而实现击发缆线582、584的致动。击发触发器130返回至起始位置时会牵拉击发缆线582、584并使第一击发衔接子140将砧座20牵拉至打开位置或使第一击发衔接子140运动至其中弹簧(未示出)将砧座20偏置到打开位置的位置处。
外科器械510还可包括刀534,刀534被可动地支撑在远侧脊段520中的刀支撑狭槽528内。参见图44B。在各种实施例中,刀杆534可由例如300或400不锈钢等加工而成,并可具有形成于其远端上的组织切割刀刃535。刀杆534附接到可由300或400系列的不锈钢加工而成的刀带536。刀带可例如包括0.007英寸至0.012英寸厚的不锈钢带材料,所述不锈钢带材料比杆更为坚硬。刀缆线536延伸穿过远侧脊构件520,并且近侧脊段530附接到刀杆480,该刀杆如上所述以驱动方式接合击发传送装置190。因此,外科医生可通过以上述方式操作刀推进触发器200来选择性地操作刀杆534以切割组织。各种实施例也可采用波纹管状的覆盖构件594以防止灰尘、组织、碎屑等对铰接接头造成污染。参见图48。
图49-53示出本发明的另一外科器械实施例。除以下所解释的不同点之外,此实施例的外科器械610基本上类似于上述外科器械实施例10。外科器械610能够致动具有两个可运动钳口613、615的端部执行器612。在各种实施例中,端部执行器612联接到从柄部组合件100突起的细长轴组合件655。参见图49。细长轴组件655包括细长的脊组件658及细长的闭合管组件680,细长的闭合管组件680可在脊组件658上沿近侧方向及远侧方向轴向地运动。如图所示,细长轴组件655沿纵向轴线A-A从柄部组件100大体上成直线地朝远侧延伸。在各种实施例中,细长轴组件655可为大约9英寸到16英寸(大约228.8mm至406.4mm)长。然而,细长轴组件655也可被设置成其它长度。
参见图50和图51,在各种实施例中,端部执行器612的下钳口613包括细长通道614,并且上钳口615包括砧座620。细长通道614具有一对间隔开的侧壁616,所述一对间隔开的侧壁616分别终止于向上突起的闭合末端或末端618中。细长通道614可由例如17-4或400系列的不锈钢加工而成,并且其尺寸可被设定成能够在其中可操作地支撑钉仓630或其它形式的钉仓。砧座620可由416、17-4、17-7不锈钢等加工而成。在至少一个实施例中,例如端部执行器612(当处于闭合位置时)及细长轴组件655各自具有最大外径以容许装置可操作地穿过具有至少大约8mm至12mm(大约0.31英寸至0.47英寸)直径的开口。然而,端部执行器612及细长轴组件655可具有其它直径及形状。端部执行器612还包括远侧脊段660,远侧脊段660能够可移除地联接到近侧脊段670的远端,下文将进一步说明。
砧座620具有缝钉成形部622,缝钉成形部622中形成有多个缝钉成形凹坑。另外,砧座620具有分为两部分的闭合部624,该闭合部包括至少一个且优选地包括一对向下延伸的闭合末端625。如在图50-53中可看出,在至少一个实施例中,闭合末端625及细长通道614的对应的闭合末端或末端618通过枢轴销626枢转地销接至脊组件658的远侧脊段660的分为两部分的远端662的脊耳633(图55),使得当从侧面观察时,闭合末端625和闭合末端618形成被总体上标识为628的可运动的“剪刀状”闭合结构。在其它实施例中,砧座620可动地联接到细长通道614。
端部执行器612的各种实施例也包括可轴向地行进的刀组件640,刀组件640包括刀板642,刀板642包括从刀板642朝远侧突起的一对间隔开的刀杆644,所述一对间隔开的刀杆644能够在远侧脊段660的脊耳663之间轴向地滑动。参见图55。刀构件646附接到或换句话讲形成于刀杆644的远端上。在各种实施例中,刀杆644及刀构件646可由例如300或400系列的不锈钢加工而成。刀构件646的远端上形成有组织切割刀刃648。刀构件646的下部649能够接合缝钉驱动橇650,该缝钉驱动橇被可动地支撑在细长轴614内。缝钉驱动橇650可保持在细长通道614内的狭槽或狭槽结构(未示出)中,以利于缝钉驱动橇650从起始位置(图50-52)轴向地运动至结束位置(图53),同时保持连接至细长通道614。缝钉驱动橇650上具有一个或多个缝钉驱动表面652,所述缝钉驱动表面被取向成以驱动方式接合钉仓630中的缝钉632,并在刀构件646穿过端部执行器612而朝远侧推进时朝砧座620的缝钉成形部622向上驱动缝钉632。
此外,在各种实施例中,远侧脊螺母668可旋转地联接到远侧脊段660的近端664,以相对于近端664绕纵向轴线A-A可旋转地行进。远侧脊螺母668具有一对向内延伸的凸耳669,所述一对向内延伸的凸耳669的尺寸被设定成能够容纳于近侧脊区段670的自柄部组件100突起的远端672中的对应凸耳狭槽674中,以使远侧脊段660能够相对于近侧脊区段670旋转。如在图49中可看出,近侧脊段670销接至旋转旋钮70(通过销66),该旋转旋钮70以上述方式可旋转地安装至柄部组件100,以利于端部执行器612绕纵向轴线A-A沿360°路径进行旋转。
如在图49中可看出,近侧脊区段670的近端671上形成有凸缘676。凸缘676能够旋转地支撑在沟槽106中,该沟槽由自壳体构件102、104中的每一者向内突起的配合肋108形成。这种结构有利于将近侧脊段670附接到柄部组件100,同时使近侧脊段670能够相对于柄部组件100沿360°路径绕纵向轴线A-A旋转。近侧闭合管段682可由聚合物或其它适宜的材料加工而成并可具有近端683,该近端683附接到击发轭114,所述击发轭114以上述各种方式构造并被可动地安装在柄部组件100内。在各种实施例中,例如击发轭114可被重叠注塑至近侧闭合管段682的近端683。然而,也可采用其它紧固件结构。如上所述,击发轭114可被旋转地支撑在支撑衬圈120中,该支撑衬圈120能够在柄部组件100中轴向地运动。如在图49中可看出,穿过近侧闭合管段682设置有纵向狭槽681,以使脊销66能够穿过纵向狭槽681而延伸至近侧脊段670中,同时有利于近侧闭合管段682在远侧脊段670上进行轴向行进。
如在图49中可看出,击发触发器130具有相对于击发链节636、638可枢转(销接)的上部134,击发链节636、638相对于支撑衬圈120可枢转(销接)。因此,击发触发器130朝柄部组件100的手枪式握把部107的运动将使击发轭114和近侧闭合管段682沿近侧方向“PD”(在图49中以虚线示出)运动。夹具和击发触发器130远离柄部组件100的手枪式握把部107的运动将使击发轭114和击发管110在近侧脊段670上沿近侧方向“DD”运动。
如在图50-53中可看出,近侧闭合管段682具有远端684,远端684能够附接到远侧闭合管段690的近端692。在所示实施例中,远侧闭合管段690能够通过螺纹附接到近侧闭合管段682的远端684。远侧闭合管段690的远端694中具有逐渐变细的驱动构件696,该逐渐变细的驱动构件696能够与剪刀状的闭合结构628交接,使得当远侧闭合管段690处于图51所示的位置时,位于细长通道614与砧座620之间的一个或多个端部执行器弹簧617用于将砧座620偏置到该图所示的打开位置。然而,当沿近侧方向“PD”牵拉远侧闭合管段690时,逐渐变细的驱动构件696会接触剪刀状的闭合结构628,以使钳口613(细长通道614)与615(砧座620)朝彼此枢转。参见图52和图53。
外科器械610还可包括刀推进系统639,刀推进系统639包括延伸穿过近侧脊区段670的刀杆700并具有以驱动方式与击发传送装置190交接的近端部分702,击发传送装置190以上述方式可操作地附接到刀推进触发器200。因此,外科医生可通过以上述方式牵拉刀推进触发器200而使刀杆700朝远侧推进。如在图52和图53中可看出,刀杆700具有分为两部分的远端704,该分为两部分的远端包括上刀杆段706和下刀杆段708,所述上刀杆段706和下刀杆段708能够接合刀板642。如在图51-54中可看出,上刀杆段706能够穿过脊螺母668中的上狭槽773而滑动,并且下刀杆段708能够穿过脊螺母668中的下狭槽775而滑动。
为使用外科器械610,通过将脊螺母668上的凸耳669插入近侧脊区段670中与其对应的凸耳支架674中而将端部执行器612附接到近侧脊区段670的远端672。参见图50。随后,外科医生或临床医生可相对于细长轴组件655旋转端部执行器612,以将远侧闭合管段690螺接到近侧闭合管段682上,从而形成闭合管组件680。端部执行器612中可具有钉仓630,或者临床医生可在此时或稍后将钉仓安装至细长通道614中。一旦端部执行器612附接到外科器械610的细长轴组件655,外科医生可通过延伸至患者体内的进入通道(例如通过套管针或内窥镜等,或通过切口—在开放式手术的情形中)插入端部执行器612及细长轴组件655,以抓紧端部执行器钳口613、615之间的靶组织。与上述各种实施例一样,通过相对于柄部组件100的手枪式握把107操纵击发触发器130来闭合钳口613、615。一旦靶组织被抓紧于端部执行器钳口613、615之间,外科医生便可通过以上述方式将砧座620压紧至钉仓630中而将缝钉632“击发”或成形到靶组织中。如果手术无需切割靶组织,则外科医生可随后释放击发触发器130,以容许砧座620运动至打开位置(在来自弹簧617的偏置运动下),从而从端部执行器612释放可植入钉仓630。随后,外科医生可再次闭合端部执行器钳口613、615,以容许端部执行器612通过进入通道或工作通道被撤出。然而,如果外科医生想要切割缝钉线632之间的靶组织,则外科医生可通过以上述方式操作刀推进触发器200来击发刀组件640,以朝远侧驱动刀构件648穿过靶组织。随着刀构件648穿过端部执行器612朝远侧运动,刀构件648会接触缝钉驱动橇650,该缝钉驱动橇用于进一步驱动缝钉632以使其与砧座620的缝钉成形表面622进行成形接触,从而使缝钉632进一步成形。参见图53。随后,外科医生可打开端部执行器612以从端部执行器612释放切割/缝合的靶组织和可植入钉仓630。
因此,通过朝远侧运动闭合管来闭合端部执行器钳口的独特且新型的闭合管结构使得能够采用更小的闭合结构,同时仍保持产生使缝钉成形所需的大的闭合力的能力。另外,本发明的此类实施例为外科医生提供在无需切割组织的应用中缝合而不切割组织的灵活性。
图56-60示出可供选择的外科器械实施例810,除以下所论述的不同点之外,外科器械实施例810与外科器械610基本上相同。外科器械810例如包括挠性脊组件820,该挠性脊组件具有近端,所述近端上具有凸缘822,该凸缘可旋转地容纳在沟槽106内,所述沟槽106由自形成柄部组件100的壳体构件102、104中的每一者向内突起的配合肋108形成。参见图57和图58。这种安装结构有利于挠性脊组件820相对于柄部组件100可旋转地运动。在各种实施例中,挠性脊组件820可由例如尼龙、丙烯腈丁二烯苯乙烯(ABS)、聚碳酸酯、液晶聚合物、不锈钢、钛等加工而成,并能够与上述类型的端部执行器612一起使用。
外科器械810还包括被总体上表示为830的细长轴组件。在各种实施例中,例如细长轴组件830包括可重构轴段840和近侧轴段844。如在图56中可看出,例如可重构轴段840可具有远侧安装衬圈842,该远侧安装衬圈例如通过粘合剂、焊接、紧固件等非可动地附接到挠性脊组件820的一部分。可重构轴段840可在其中可重构的段840的所有部分均基本上以同轴方式相互对齐(即,其形成基本上直的中空管状结构)的线性构型与其中可重构的段840的所述部分中的至少一部分不以同轴方式或线性方式与另一部分对齐的构型之间选择性地重构。在图56所示的实施例中,例如可重构轴段840可由尼龙、丙烯腈丁二烯苯乙烯(ABS)、聚碳酸酯等加工而成,并可具有多个肋846,所述多个肋846有利于段840从线性或同轴对齐的取向重构至非线性或非同轴的(例如蜿蜒的、弯曲的等)取向并保持这种取向,直至使用者用手或通过使用其它外科器械(例如抓紧装置等)来重构轴段840。因此,可重构轴段840是“可被动铰接的”,这是指该装置未配备有用于主动控制段840的铰接的铰接装置。
在各种实施例中,近侧轴区段844例如通过互锁结构或销而联接到可重构的轴区段840,并用于有利于可重构的轴区段840可旋转地附接到柄部组件100。在至少一个实施例中,例如近侧轴段844联接到安装轴衬60,该安装轴衬以上述方式可旋转地附连到柄部组件100。参见图57和图59。
此外,在各种实施例中,闭合管段832被可动地安装在挠性脊组件820上,以在挠性脊组件820上选择性地行进。参见图56和图60。如在图60中可看出,在至少一个实施例中,闭合管段832及脊组件820分别形成有相对的凸缘部833、821,使得能够防止闭合管段832从脊组件820上滑脱,同时保持被可动地安装在脊组件820上。在各种实施例中,挠性闭合构件848联接到击发轭114或包括击发轭114的一部分。参见图57和图59。挠性闭合构件848可由例如不锈钢等加工而成并可具有延伸穿过脊组件820中的细长狭槽834以联接到闭合管段832的远端部分849。这种结构有利于通过以上述方式致动击发触发器130而使闭合管段832在脊组件820上沿远侧方向“DD”及近侧方向“PD”运动。
如在图56中可看出,外科器械810可与上文中所详细描述的端部执行器612一起使用。具体地讲,可通过将脊螺母668上的凸耳669插入脊组件820的远端825中对应的凸耳狭槽825中而将端部执行器612可移除地联接到挠性脊组件820。参见图60。闭合管段832的远端835能够以上述方式通过螺纹附接到远侧闭合管段690的近端692。
在至少一个实施例中,外科器械810还包括刀推进系统639,刀推进系统639包括延伸穿过脊组件820的刀杆700并具有以驱动方式与击发传送装置190交接的近端部分702,击发传送装置190以上述方式可操作地附接到刀推进触发器200。因此,外科医生可通过以上述方式牵拉刀推进触发器200而使刀杆700朝远侧推进。刀杆700具有分为两部分的远端704,该分为两部分的远端704包括上刀杆段706和下刀杆段708,所述上刀杆段706和下刀杆段708能够接合端部执行器612中的刀板642。参见图60。
为使用外科器械810,通过将脊螺母668上的凸耳669插入与其对应的凸耳支架825中而将端部执行器612附接到脊组件820的远端823。随后,外科医生或临床医生可旋转端部执行器612以将远侧闭合管段690螺接到闭合管段832上。端部执行器612中可具有钉仓630,或者临床医生可在此时将钉仓安装至细长通道614中。一旦端部执行器612附接到外科器械810的细长闭合管组件830,外科医生便可将可重构轴段840构造成使得各细长轴组件部分以同轴方式对齐,以通过延伸至患者体内的开口或工作通道(例如通过套管针或内窥镜等,或通过切口—在开放式手术的情形中)插入。随后,外科医生可将可重构轴段840重构,使得其各部分不以同轴方式相互对齐,以相对于靶组织将附接到可重构轴段840的端部执行器612取向于期望的位置中。与上述各种实施例一样,通过相对于柄部组件100的手枪式握把107操纵击发触发器130来闭合钳口613、615。一旦靶组织被抓紧于端部执行器钳口613、615之间,外科医生便可通过以上述方式将砧座620压紧至钉仓630中而将缝钉632“击发”或成形到靶组织中。如果手术无需切割靶组织,则外科医生可随后释放击发触发器130,以容许砧座620运动至打开位置(在来自弹簧617的偏置运动下),从而从端部执行器612释放可植入钉仓630。随后,外科医生可再次闭合端部执行器钳口613、615并对可重构轴段840进行重构,以容许端部执行器612通过进入通道或工作通道而被撤出。然而,如果外科医生想要切割缝钉线632之间的靶组织,则外科医生可通过以上述方式操作刀推进触发器200来击发刀组件640,以朝远侧驱动刀构件648穿过靶组织。随着刀构件648穿过端部执行器612朝远侧运动,刀构件648会接触缝钉驱动橇650,该缝钉驱动橇用于进一步驱动缝钉632以使其与砧座620的缝钉成形表面622进行成形接触,从而使缝钉632进一步成形。随后,外科医生可打开端部执行器612以从端部执行器612释放切割/缝合的靶组织和可植入钉仓630。
图61和62示出另一外科器械实施例810’,外科器械实施例810’与上述外科器械810实施例基本上相同,不同之处在于,可重构的轴区段850包括细长轴组件830’的可操作地联接到柄部组件100的一部分,以用于操作端部执行器612。在各种实施例中,可重构轴段850包括可动地互连的多个管状链节852。每一管状链节852可例如由具有或不具有玻璃或碳填充的尼龙、丙烯腈丁二烯苯乙烯(ABS)、聚碳酸酯等加工而成,并可具有管状本体部854。管状本体部854上可形成有球形或球状联接器部856,该球形或球状联接器部具有穿过其中的脊容纳通道858。另外,管状脊容纳通道858延伸至形成于管状本体部854中的中空承窝860中,该中空承窝的尺寸被设定成可动地容纳相邻管状链节852的球状联接器部856。球状联接器部856的尺寸相对于承窝860被设定成容许球状联接器部856按扣于其中并保持在其中轴段基本上成直线的期望构型至其中轴850可具有弯曲构型(图62)或蜿蜒状构型(图61)的构型。
尽管球状联接器部856及承窝860的尺寸可相对于彼此设定成在其间形成小的摩擦力,以将区段850保持在期望取向中直至对其施加外力为止,然而图60和图61所示的实施例采用锁定系统862,以将各管状链节852一起可释放地保持或非可动地锁定在期望构型中。如在这些图中可看出,锁定装置862包括在其一端853附近形成于管状链节852的周边上至少一个、优选地多个挠性闩锁结节或构件864。在一个优选的实施例中,采用4个闩锁结节864。其它实施例可具有1、2、3个或多于4个闩锁结节864。每一管状链节852还包括与邻近链节852另一端865的每一闩锁结节864相对应的锁定构件866。每一锁定构件866中具有闩锁容纳凹口868,该闩锁容纳凹口能够在其中可释放地容纳形成于相邻管状链节852上的对应闩锁结节864的一部分。
为使用外科器械810’,需以上述方式将端部执行器612附接到脊组件820的远端823。端部执行器612的远侧闭合管段690螺接至闭合管段832上。一旦端部执行器612附接到外科器械810’的细长闭合管组件830,则外科医生可将可重构轴段850构造成使得各细长轴组件部分以同轴方式对齐,以通过延伸至患者体内的开口或工作通道(例如通过套管针或内窥镜等,或通过切口—在开放式手术的情形中)插入。随后,外科医生可例如采用抓紧器械869来将可重构轴段850的可运动的链节852构造至期望取向,并随后将每一链节852上的适当锁定结节864按压至其对应的闩锁容纳凹口868中,以将各链节852锁定在期望取向中。参见图62。与上述各种实施例一样,通过相对于柄部组件100的手枪式握把107操纵击发触发器130来闭合钳口613、615。一旦靶组织被抓紧于端部执行器钳口613、615之间,外科医生便可通过以上述方式将砧座620压紧至钉仓630中而将缝钉632“击发”或成形到靶组织中。如果手术无需切割靶组织,则外科医生可随后释放击发触发器130,以容许砧座620运动至打开位置(在来自弹簧617的偏置运动下),从而从端部执行器612释放可植入钉仓630。随后,外科医生可再次闭合端部执行器钳口613、615并使用抓紧器械869将各锁定结节864从其对应的闩锁容纳凹口868中移除,以容许各链节852对齐,从而容许装置能够通过进入通道或工作通道而被撤出。然而,如果外科医生想要切割缝钉线632之间的靶组织,则外科医生可通过以上述方式操作刀推进触发器200来击发刀组件640,以朝远侧驱动刀构件648穿过靶组织。随着刀构件648穿过端部执行器612朝远侧运动,刀构件648会接触缝钉驱动橇650,该缝钉驱动橇用于进一步驱动缝钉632以使其与砧座620的缝钉成形表面622进行成形接触,从而使缝钉632进一步成形。随后,外科医生可打开端部执行器612以从端部执行器612释放切割/缝合的靶组织及可植入钉仓630。
图63-68示出另一外科器械实施例810”,除细长轴组件的可重构的轴区段870及相关的锁定系统882之外,外科器械实施例810”与上述外科器械实施例810、810’基本上相同。在各种实施例中,可重构轴段870包括可动地互连的多个管状链节872并联接到近侧轴段871,该近侧轴段联接到安装轴衬60,该安装轴衬60如上文详细所述被旋转地支撑在柄部组件100中。每一管状链节872可例如由尼龙、丙烯腈丁二烯苯乙烯(ABS)、聚碳酸酯等加工而成,并可具有管状本体部874。参见图67。管状本体部874上可形成有球形或球状联接器部876,球形或球状联接器部876具有穿过其中而延伸的脊容纳通道878。另外,管状脊容纳通道878延伸至形成于管状本体部854中的中空承窝880中,该中空承窝的尺寸被设定成可动地容纳相邻管状链节872的球状联接器部876。球状联接器部876的尺寸相对于承窝880被设定成容许球状联接器部876按扣于其中并保持在其中可重构轴段870基本上成直线(图67)的期望构型至其中轴870可具有弯曲的(图68)或蜿蜒状构型的构型。
尽管在至少一个实施例中,球状联接器部876及承窝880的尺寸可相对于彼此被设定成在其间形成小的摩擦力,以将可重构的轴区段870的管状链节872保持在期望取向中直至对其施加外力为止,然而图63-68所示的实施例采用锁定系统882,以将各管状链节872一起可释放地保持或非可动地锁定在期望构型中。如在图67和图68中可看出,锁定装置882包括延伸穿过处于直径相对位置的管状链节872的至少一个、且优选地两个能选择性膨胀的锁囊884。在各种实施例中,锁囊884可例如由尼龙膜等加工而成并能够容纳来自加压流体源886的加压流体。在图64所示的实施例中,加压流体源886包括流体泵结构888,该流体泵结构888能够在压力作用下将空气供给至锁囊884中。具体地讲,在至少一个实施例中,流体泵结构888包括其中具有活塞890的汽缸889。活塞890具有围绕于其周边的O形环或其它密封结构891并附接到螺纹泵柄部892,该螺纹泵柄部892螺纹接合柄部组件100的一部分。因此,通过将泵柄部892旋入柄部组件100中,汽缸890中的空气会在压力作用下通过自汽缸890延伸至歧管组件894的供给管道893而被泵送,该歧管组件被容纳在脊组件820上。可通过沿相反方向旋动泵柄部894而将气压释放于锁囊884中。
如在图65中可看出,歧管组件894包括由O形环或其它密封件896密封于每一侧上的环形歧管区域895。环形歧管区域895与供给管线897连通,该供给管线延伸穿过近侧轴段871并联接到锁囊884或在锁囊884中卸料。这种结构用于将加压空气供给至锁囊884中,同时有利于脊组件820相对于柄部组件100绕纵向轴线A-A可旋转地运动。如本文所用,术语“加压流体”可包括例如空气、盐溶液、或优选地为甘油。在可供选择的实施例中,管状构件可填充有硬度非常低的橡胶或弹性体。当对橡胶材料施加压力时,橡胶材料会变形以填充空隙并以与流体实施例差不多的方式锁定轴。
为使用外科器械810”,需以上述方式将端部执行器612附接到脊组件820’的远端823。端部执行器612的远侧闭合管段690螺接至闭合管段832上。一旦端部执行器612附接到外科器械810”的细长轴组件830”,则外科医生可将可重构轴段870构造成使得各细长轴组件部分830”以同轴方式对齐,以通过延伸至患者体内的开口或工作通道(例如通过套管针或内窥镜等,或通过切口—在开放式手术的情形中)插入。随后,外科医生可采用例如抓紧器械来将可重构轴段870的可运动链节872构造至期望取向。一旦可重构轴段870取向在期望取向中,则外科医生可随后将泵柄部892旋至柄部壳体100中以对锁囊884加压,从而将可运动的链节872锁定在如图68所示的位置。与上述各种实施例一样,通过相对于柄部组件100的手枪式握把107操纵击发触发器130来闭合钳口613、615。一旦靶组织被抓紧于端部执行器钳口613、615之间,外科医生便可通过以上述方式将砧座620压紧至钉仓630中而将缝钉632“击发”或成形到靶组织中。如果手术无需切割靶组织,则外科医生可随后释放击发触发器130,以容许砧座620运动至打开位置(在来自弹簧617的偏置运动下),从而从端部执行器612释放可植入钉仓630。随后,外科医生可再次闭合端部执行器钳口613、615并通过沿相反的方向旋动泵柄部892而释放锁囊884中的压力。可采用抓紧器械来将可运动的链节872调控至基本上同轴对齐的取向(图67)或使装置能够从患者体内被撤出期望的其它方向。然而,如果外科医生想要切割缝钉线632之间的靶组织,则外科医生可通过以上述方式操作刀推进触发器200来击发刀组件640,以朝远侧驱动刀构件648穿过靶组织。随着刀构件648穿过端部执行器612朝远侧运动,刀构件648会接触缝钉驱动橇650,该缝钉驱动橇用于进一步驱动缝钉632以使其与砧座620的缝钉成形表面622进行成形接触,从而使缝钉632进一步成形。随后,外科医生可打开端部执行器612以从端部执行器612释放切割/缝合的靶组织及可植入钉仓630。
本文所公开的包括可重构的轴区段的各种实施例大大改良了采用可锁定铰接接头的传统的可铰接外科器械结构。这种外科器械的端部执行器在横切部位的放置通常被限制到1或2个自由度。本发明的各种实施例使得端部执行器的可能位置范围更宽并因此使外科医生在通过单个入口使用装置时具有更大的灵活性。
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缝钉能够排列成一条或多条线性或非线性的线。细长狭槽的每一侧上可设置有多条这种缝钉线,所述细长狭槽居中地设置于钉仓内,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,例如成一条线的缝钉可大体上平行于位于相邻缝钉线中的缝钉但与其偏离。在另一些实施例中,一条或多条缝钉线可本质上为非线性的。换言之,缝钉线中的至少一个缝钉的基部可沿基本上与同一缝钉线中的其它缝钉的基部横切的轴线延伸。例如,如以下将更详细地论述,在可供选择的实施例中,细长狭槽的每一侧上的缝钉线可具有锯齿形外观。这种非线性的缝钉排列方式可行的原因在于,缝钉不被向上驱动至砧座中。相反,在这些各种实施例中,砧座与不运动的缝钉的末端进行成形接触。与其中缝钉实际被向上驱动以与砧座进行成形接触的现有技术的钉仓中所采用的各种线性缝钉排列方式相比,这种非线性的缝钉排列方式可使用更少的缝钉获得更好的组织紧固结果。
图69示出本发明的端部执行器实施例612’中的外科钉仓实施例900的使用。端部执行器612’可以上述各种方式与外科器械610结合使用。除以下所述不同点之外,端部执行器612’可与上述端部执行器612相同。如在图69和图70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605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外科器械610的刀本体646穿过细长狭槽904轴向地运动。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缝钉922形成的线920、930。然而,仓体902也可由用于将未成形的缝钉922支撑在期望取向以使砧座910与成形的缝钉922接触时未成形的缝钉922可被压缩的其它材料加工而成。与上述各种其它实施例一样,钉仓900是可植入的且在缝合手术完成之后被留下并附接到被缝合的组织。在至少某些实施例中,为防止缝钉922受影响并防止止血材料在引入及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的尺寸设定成被可移除地支撑在端部执行器612’的细长通道614内。
在图69、图73、及图74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上支撑缝钉922形成的第一线920,并在细长狭槽904的另一横向侧909上支撑缝钉922形成的第二线930。在各种实施例中,缝钉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缝钉基部924和从缝钉基部924突起的两个直立的缝钉腿926。每一缝钉腿926上可形成有组织刺穿末端928。在缝钉922形成的第一线920中,至少一个缝钉922的缝钉基部924与另一缝钉922的缝钉基部交搭。在一个优选的实施例中,除位于第一缝钉线920每一末端上的最后缝钉922的基部924之外,每一缝钉922的缝钉基部924均与两个相邻缝钉922的缝钉基部924交搭。参见图73。因此,第一缝钉线920具有基本上非线性的形状。更具体地讲,当从上方观察时,第一缝钉线920具有基本上锯齿形的外观。
如在图72中可看出,砧座90具有两个相继形成的纵向缝钉成形凹坑912,每一纵向缝钉成形凹坑912具有与缝钉922形成的第一线920的形状对应的基本上锯齿形的形状,使得当砧座910与缝钉922进行成形接触时,缝钉922的腿部926如图74所示成形。因此,一个缝钉的远侧腿部与在纵向上的下一缝钉的近侧腿部共享同一凹坑。这种结构能够形成更密集的凹坑图案,甚至达到缝钉自身进行相互作用(例如跨过彼此而折叠)的程度。在现有技术的缝钉凹坑结构中,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/交搭间隔结构(本质上,a-0.020"),这是因为一个缝钉与下一个缝钉相配合。这种结构使得能够在相同的空间中包括多出15%至30%的缝钉。此外,当各缝钉互锁时,对多个侧向缝钉排的需求减少。现有的结构通常在组织切割线的每一侧上采用三排缝钉,以防止存在血液可流过的开放路径。互锁缝钉线形成血液可流过的路径的可能性更小。本发明的各种互锁缝钉结构所提供的另一明显的优点涉及与撕开缝钉线开口所需力的大小相关的改良“破裂强度”。
本发明的另一缝钉成形凹坑结构可包括共用的缝钉成形凹坑。如本文所用,术语“共用的缝钉成形凹坑”是指,与其中针对每一预成形缝钉的每一腿部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缝钉线中的所有缝钉成形。
图75示出另一个缝钉实施例922’,其中基部924’具有偏移部928,以利于各基部924’进行更紧密的交搭。如上所述,钉仓900具有支撑在细长狭槽904的第二横侧909上的缝钉922的第二线930。缝钉922的第二线930与缝钉922的第一线920基本上相同。因此,砧座910具有对应于第二缝钉线930的第二共用缝钉成形凹坑912,以与第二缝钉线930成形接触。然而,在可供选择的实施例中,缝钉922的第二线930可在形状上并可能在缝钉数目上不同于第一缝钉线920。
图71示出外科钉仓900’,除支撑在其中的缝钉922形成的线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,缝钉922的线920’相对于彼此被设定成使得至少一个缝钉基部924的基部轴线S-S基本上横切至少一个另一相邻缝钉922的缝钉基部924的基部轴线S-S。当从上方观察时,这种预定的缝钉图案包括基本上锯齿形的排列。在图76所示的实施例中,缝钉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有利于在不使缝钉自身交搭的情况下使各缝钉之间进行互锁。因此,这种结构可在不使缝钉自身的腿部交搭的情况下使缝钉成形为“B”形或倒“W”形。然而,由于冠部通过基部支撑构件相连,因此冠部像交搭的缝钉一样起作用。这种结构容许相结合的凹坑针对每一腿部具有两个独立的路径。
图77所示的实施例采用缝钉线920”,在缝钉线920”中,相邻缝钉922的腿部926通过以模制或其它方式附接到腿部926的联接器部929联接在一起。每一联接器部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,这种缝钉线920”具有基本上锯齿形的外观。尽管结合与端部执行器612’及外科缝合器械610一起使用来解释各种外科缝钉实施例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它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适当的缝钉成形凹坑,以便在砧座运动至与缝钉进行成形接触时达到期望的缝钉成形量。
图78和79示出支撑在本发明外科器械10的细长通道14中的另一外科钉仓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的刀本体穿过细长狭槽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缝钉922形成的线946、948、950和952。在至少某些实施例中,为防止缝钉922受影响并防止止血材料在引入及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78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中。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相配合。在一个优选的实施例中,仓支撑构件960具有从其突起的一个或多个按扣结构962,以用于将仓支撑构件960可释放地联接到细长通道14。可采用其它形式的按扣结构/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、及976,以对缝钉线946、948、950、及952中的缝钉922的基部924提供某种程度的横向支撑。因此,在至少某些实施例中,支撑脊与缝钉线是基本上同延的。图80示出可供选择的钉仓实施例940’,钉仓实施例940’与仓940基本上相同,不同之处在于,钉仓实施例940’包括分别自支撑脊964、966、968、970、972、和976突起以对缝钉922提供额外侧向支撑的直立翅片部978、979、980、981、982、和983。在各种实施例中,翅片部可与仓支撑构件960形成为一体,并且其高度可为仓高度的大约1/2或以下。因此,在优选的实施例中,例如任何用于支撑泡沫的直立结构皆无法延伸至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,一旦缝钉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。这种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,外科医生仅需将仓支撑构件960的按扣结构从细长通道14脱离,以使新的钉仓940的仓支撑构件960能够被放置于细长通道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它外科器械实施例一起使用。
图81和82示出外科器械实施例10结合端部执行器990的使用,除可动地联接到细长通道14或换句话讲支撑在细长通道14中的闭合锁定装置991之外,端部执行器990与上述端部执行器12基本上相同。在各种实施例中,闭合锁定装置991包括具有远端993和近端994的锁定臂992。锁定臂992绕枢轴构件或凸耳995枢转地联接到细长通道。远端部分具有附接到远端部分的片簧996或其它偏置构件以将锁定臂992偏置到致动或锁定位置;在致动或锁定位置中,近端994接合第一击发衬圈141的远端141以防止第一击发衬圈140朝远侧推进至“击发”位置。然而,当细长通道14中安装有钉仓30时,钉仓30会使锁定臂992运动至非致动或非锁定位置中,使得击发衬圈140可朝远侧推进超过锁定臂992,以完成缝钉击发过程。参见图81。
当处于锁定位置时,击发衬圈140无法朝远侧被推进而完成击发过程。另外,击发触发器130无法推进至完全击发位置,在完全击发位置中,刀锁定杆210运动至解锁位置,从而使外科医生能够使刀杆172推进。因此,当端部执行器990中不存在仓时,闭合锁定装置991处于锁定位置,这最终会防止刀杆172推进。因此,除非端部执行器990中存在仓30,否则外科医生无法使刀杆172推进来切割组织。应当理解,在不背离本发明的实质和范围的条件下,上述闭合锁定装置991可有效地合并于本文所公开的许多外科器械实施例中。
在各种实施例中,钉仓可包括仓体及存储在仓体中的多个缝钉。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,可将缝钉成形砧座定位在组织的相对侧上。在各种实施例中,砧座可由第一钳口携载且钉仓可由第二钳口携载,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被定位,则可从钉仓本体中射出缝钉,使得缝钉可刺穿组织并接触缝钉成形砧座。一旦从钉仓本体中部署缝钉,则可从手术部位移除钉仓本体。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缝钉。在至少一个此类实施例中,如以下所更详细地描述,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,位于仓体中的缝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,当缝钉至少部分地位于仓体中时,缝钉可被变形。在某些实施例中,缝钉可不从钉仓中被射出,而在一些实施例中,缝钉可与仓体的一部分一起从钉仓中被射出。
现在参见图83A-83D,可压缩的钉仓(例如钉仓1000)例如可包括可压缩、可植入的仓体1010,另外,位于可压缩仓体1010中的多个缝钉1020绘示于图83A-83D中(然而图中仅示出一个缝钉1020)。图83A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。在这种未压缩状态中,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83B所示)以及组织T抵靠仓体1010的位置。即使砧座1040可将组织T定位成抵靠钉仓本体1010的组织接触表面1019,然而再次参见图83B,钉仓本体1010可受到小的(如果有的话)压缩力或压力,使得缝钉1020可保持在未成形或未击发状态。如图83A和图83B所示,钉仓本体1010可包括一个或多个层,并且缝钉1020的缝钉腿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可定位在第一层1011与第三层1013之间,其中第三层1013可定位在第二层1012和第四层1014之间。在至少一个实施例中,例如缝钉1020的基部1022可定位在第四层1014中的腔1015中,并且缝钉腿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,每一可变形腿部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可定位在第三层1013和/或任何其它适宜的层中。在各种可供选择的实施例中,钉仓的仓体可具有任何适宜数目的层,例如少于四层或多于四层。
在各种实施例中,如以下所更详细地描述,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中的一者或多者可将缝钉1020保持在钉仓本体1010中,并且另外可使缝钉1020保持相互对齐。在各种实施例中,第三层1013可由支撑材料或相当不可压缩的或非弹性材料构成,所述材料能够将缝钉1020的缝钉腿1021相对于彼此保持就位。此外,即使能够由可压缩的泡沫或弹性材料构成,位于第三层1013的相对两侧上的第二层1012和第四层1014也可稳定或减少缝钉1020的运动。在某些实施例中,缝钉腿1021的缝钉末端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缝钉腿1021保持就位。在至少一个实施例中,第一层1011和第三层1013可分别由可生物吸收材料(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)形成的薄片构成,并且第二层1012和第四层1014可分别由至少一种止血材料或剂构成。
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的约两倍、约三倍、约四倍、约五倍、和/或约十倍。换言之,针对给定的力,第二层1012的压缩程度可为第一层1011的约两倍、约三倍、约四倍、约五倍、和/或约十倍。在某些实施例中,第二层1012的可压缩性可在第一层1011的约两倍与约十倍之间。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能够为可压缩的,然而第四层1014能够比第三层1013基本上更可压缩。例如,第四层1014的可压缩性可为第三层1013的约两倍、约三倍、约四倍、约五倍、和/或约十倍。换言之,针对给定的力,第四层1014的压缩程度可为第三层1013的约两倍、约三倍、约四倍、约五倍、和/或约十倍。在某些实施例中,第四层1014的可压缩性可在第三层1013的约两倍与约十倍之间。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。在各种情形中,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可由相同的材料构成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可由具有不同压缩率的材料构成。相似地,第一层1011和第三层1013可由相同的材料构成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可由具有不同压缩率的材料构成。
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83C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,仓支撑表面1031能够当钉仓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可接触缝钉1020。更具体地讲,在各种实施例中,仓体1010的压缩和组织接触表面1019向下的运动可使缝钉腿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,并且因此腿部1021可向内变形或卷曲,例如图83C所示。当缝钉腿1021被变形时,同样如图83C所示,缝钉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,如以下将更详细地描述,钉仓支撑件1030可包括多个支撑结构,例如缝钉支撑沟槽、狭槽、或槽1032,所述多个支撑结构能够当缝钉1020被变形时支撑缝钉1020或至少缝钉1020的基部1022。同样如图83C所示,施加至钉仓本体1010的压缩力可使第四层1014中的腔1015塌缩。除腔1015之外,钉仓本体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缝钉的一部分,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83B和图83C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可使缝钉1020变形至其完全成形形状(如图83D所示)。参见图83D,每一缝钉1020的腿部1021可朝每一缝钉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的一部分捕获在可变形腿部1021与基部1022之间。在比较图83C和图83D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83C和图83D时也可注意,第一层1011和第三层1013也被进一步压缩。在缝钉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而运动。如图83D所示,作为上文的结果,仓体1010可植入有缝钉1020。在各种实施例中,被植入的仓体1010可沿缝钉线支撑组织。在某些情形中,被植入的仓体1010中容纳的止血剂和/或任何其它适宜的治疗药物可随着时间来处理组织。如上所述的止血剂可减少所缝合和/或所切割的组织出血,同时键合剂或组织粘合剂可随着时间的进行为组织提供强度。所植入的仓体1010可由例如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的复合物等材料构成。在某些情形中,仓体1010可包括能够减小手术部位感染的可能性的抗生和/或抗菌材料,例如胶体银和/或三氯生。
在各种实施例中,仓体1010的各层可彼此连接。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可分别包括相对应的互锁结构,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可分别包括相对应的互锁结构,同时第三层1013和第四层1014可分别包括相对应的互锁结构。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,每一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,除通过仓体1010中所容纳的缝钉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,缝钉腿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,并且一旦缝钉成形,则各层可被捕获在缝钉1020中。在某些实施例中,缝钉腿1021的至少一部分可包括能够增大缝钉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,如以下所更详细描述,钉仓1000可包括一个或多个保留结构,所述一个或多个保留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,而无需使钉仓本体1010中所容纳的缝钉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可不对钉仓本体1010施加压缩力,而在某些其它实施例中,当第二钳口处于其部分闭合的中间位置时,砧座1040可压缩钉仓本体1010。尽管当砧座1040处于这种中间位置时可压缩钉仓本体1010,然而砧座1040可不完全地压缩钉仓本体1010,以使砧座1040接触缝钉1020和/或使得缝钉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84A-84D,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之间的可植入钉仓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84A,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处于这种位置时,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,现在参见图84B,当砧座1140朝钉仓支撑件1130运动时,砧座1140可向下推动钉仓1100的顶面或组织接触表面1119并压缩仓体1110的第一层1111和第二层1112。再次参见图84B,当层1111及层1112被压缩时,第二层1112可被压溃,并且缝钉1120的腿部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,缝钉1120可至少部分地定位在第二层1112中的缝钉腔或空隙1115中,并且当第二层1112被压缩时,缝钉腔1115可塌缩并因此容许第二层1112围绕缝钉1120而塌缩。在各种实施例中,第二层1112可包括覆盖部1116,该覆盖部可延伸于缝钉腔1115之上并围绕或至少部分地围绕缝钉腔1115。图84B示出被向下压溃至缝钉腔1115中的覆盖部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,这种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可包括能够有利于缝钉腿1121穿透第一层1111的一个或多个弱化部分。在各种实施例中,这种弱化部分可包括例如能够与缝钉腿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84A,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84B,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。在各种情形中,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84C,当砧座1140运动至更靠近仓支撑表面1131时,第二层1112可继续塌缩且缝钉腿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84D,砧座1140可运动至最终的击发位置,在最终的击发位置中,缝钉1120完全成形或至少成形至期望高度。在这种位置中,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84D所示,缝钉腔1115可完全或至少基本上塌缩,并且缝钉1120可完全或至少基本上被塌缩的第二层1112围绕。在各种情形中,砧座1140可随后远离钉仓1100运动。一旦砧座1140从钉仓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,相邻的缝钉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,成形的缝钉1120及另外位于相邻的缝钉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84A所示的实施例,每一缝钉1120可包括自其延伸的缝钉腿1121。尽管缝钉1120被绘示为包括两个缝钉腿1121,然而也可利用可包括一个缝钉腿或作为另一选择包括超过两个缝钉腿(例如三个缝钉腿或四个缝钉腿)的各种缝钉。如图84A所示,每一缝钉腿1121均可嵌入仓体1110的第二层1112中,使得缝钉1120固定于第二层1112中。在各种实施例中,缝钉1120可被插入仓体1110的缝钉腔1115中,使得缝钉腿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1116中并切割第二层1112。在各种实施例中,缝钉1120可被密封至第二层1112中的足够深度处,使得缝钉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,缝钉1120可被密封至第二层1112中的足够深度处,使得基部1122被定位或嵌入缝钉腔1115中。在各种其它实施例中,基部1122可不被定位或嵌入第二层1112中。再次参见图84A,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,缝钉1120的基部1122可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,以下将更详细地叙述之。
对上文进行进一步描述,现在参见图85,缝钉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,包括其中缝钉基部1122包括圆形或拱形底部表面1124的实施例,例如缝钉基部1122可沿钉仓支撑表面1131运动或滑动。当砧座1140在缝钉成形过程期间被压抵缝钉腿1121的末端1123时会发生这种滑动。在某些实施例中,如上所述且现在参见图86,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1132能够消除或至少减少缝钉基部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,每一支撑狭槽1132均可由表面轮廓限定,所述表面轮廓与位于支撑狭槽1132中的缝钉底部表面的轮廓相匹配或至少基本上相匹配。例如,图86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可帮助防止或减少缝钉1120与钉仓支撑件1130之间的相对滑动运动,然而狭槽1132也能够防止或减少缝钉1120与钉仓支撑件1130之间的相对旋转运动。更具体地讲,在至少一个实施例中,狭槽1132能够紧密地容纳基部1122,以便防止或减少缝钉1120绕轴线1129的旋转,例如以使缝钉1120在被变形时不会旋转或扭曲。
在各种实施例中,进一步对上文进行描述,每一缝钉1120均可由圆的或至少基本上为圆的线材形成。在某些实施例中,每一缝钉的腿部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这种缝钉的基部。现在参见图87,在各种实施例中,每一缝钉1120均可包括重叠注塑至基部1122上的冠部1125(例如冠部1125),其中每一冠部1125均可定位在钉仓支撑件1130中的支撑狭槽内。在至少一个此类实施例中,每一冠部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,并可通过例如注模方法围绕缝钉1120的基部1122而形成。各种冠部及用于形成各种冠部的方法公开于2006年9月29日提出申请的名称为“SURGICALSTAPLES HAVING COMPRESSIBLE OR CRUSHABLE MEMBERS FORSECURING TISSUE THEREIN AND STAPLING INSTRUMENTS FORDEPLOYING THE SAME”的美国专利申请序列号11/541,123中。再次参见图87,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,缝钉1120的基部和/或冠部可定位在狭槽1134内。在某些实施例中,当钉仓1100被组装至钉仓支撑件1130时,缝钉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,直至对缝钉腿1121施加压缩力且缝钉1120的基部和/或冠部被向下推动至狭槽1134中。
现在参见图88和图89,在各种实施例中,钉仓(例如,钉仓1200)可包括可压缩并可植入的仓体1210,仓体1210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内的多个缝钉1220。在各种实施例中,每一缝钉1220均可包括基部1222和从基部1222延伸的一个或多个缝钉腿1221。在至少一个此类实施例中,缝钉腿1221可插入内层1212中并被密封至例如使缝钉1220的基部1222邻接和/或邻近内层1212的底部表面1218定位。在图88和图89所示的实施例中,内层1212不包括能够容纳缝钉1220的一部分的缝钉腔,而在其它实施例中,内层1212可包括这种缝钉腔。在各种实施例中,对上文进行进一步描述,内层1212可由能够容许仓体1210在对其施加压缩负载时进行塌缩的可压缩材料(例如可生物吸收的泡沫和/或氧化再生纤维素(ORC))构成。在各种实施例中,内层1212可由例如包含聚乳酸(PLA)和/或聚乙醇酸(PGA)的冻干泡沫构成。ORC可以商品名Surgicel商购获得并可包括松的织物(像外科海绵一样)、松的纤维(像棉球一样)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被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88和图89,在各种实施例中,外层1211可由水不可渗透的或至少水基本上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被压缩且缝钉腿穿透外层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。在某些实施例中,外层1211可包括环绕内层1212及缝钉1220的包裹物。更具体地讲,在至少一个实施例中,缝钉1220可被插入内层1212及外层1211中并围绕包括内层1212和缝钉1220的子组件而被包裹并随后被密封。
现在参见图90和图91,在各种实施例中,钉仓(例如,钉仓1300)可包括可压缩并可植入的仓体1310,仓体1310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内的缝钉1320,其中每一缝钉1320均可包括基部1322和从基部1322延伸的一个或多个腿部1321。类似于钉仓1200,缝钉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可具有足够的挠性来包围每一缝钉基部1322,使得外层1311适形于基部1322的轮廓。再次参见图89,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延伸而不适形于每一基部1222。在任何情形中,在各种实施例中,外层1311可定位在缝钉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92和图93,在各种可供选择的实施例中,钉仓(例如钉仓1400)的外层可不完全地围绕位于其中的缝钉。在至少一个此类实施例中,在缝钉1420的缝钉腿1421插入仓体1410中之前,可压缩并可植入的仓体1410的外层1411可被组装至内层1412。作为上文的结果,缝钉1420的基部1422可延伸于外层1411的外侧,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,当缝钉腿1421插穿外层1411时,缝钉腿1421可切开外层1411。在各种情形中,由缝钉腿1421形成的孔可紧密地围绕缝钉腿1421,使得缝钉腿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本体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88和图89,缝钉1220的腿部1221可嵌入仓体1210内,并且缝钉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可不包括能够容纳缝钉1220的缝钉腔。现在参见图94和图95,在各种其它实施例中,钉仓(例如钉仓1500)可包括可压缩并可植入的仓体1510,该仓体包括能够在其中容纳缝钉1520的至少一部分的缝钉腔1515。在至少一个此类实施例中,缝钉1520的缝钉腿1521的顶部可嵌入内层1512中,而缝钉腿1521的底部及基部1522可定位在缝钉腔1515内。在某些实施例中,基部1522可完全定位在缝钉腔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中的缝钉1520。现在参见图96,在某些其它实施例中,钉仓1600可包括位于可压缩并可植入的仓体1610中的缝钉腔1615内的缝钉1620,其中缝钉1620的至少一部分未被外层1611围绕。在至少一个此类实施例中,每一缝钉1620均可包括至少部分地嵌入内层1612中的缝钉腿1621以及围绕外层1611向外延伸的基部1622。
现在参见图97和图98,在各种实施例中,钉仓(例如,钉仓1700)可包括可压缩并可植入的仓体1710以及至少部分地位于仓体1710内的多个缝钉1720。仓体1710可包括外层1711、内层1712、和对齐矩阵1740,该对齐矩阵能够将缝钉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)适宜地固定至内层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,每一缝钉1720均可包括基部1722和从基部1722延伸的一个或多个腿部1721,其中缝钉腿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缝钉腿1721。在至少一个此类实施例中,每一孔均能够紧密地容纳缝钉腿1721,使得缝钉腿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,并且当缝钉腿1721被推动穿过对齐矩阵1740时,缝钉腿1721可需要切开对齐矩阵1740。
在某些实施例中,对齐矩阵1740可由模制的塑性本体构成,在至少一个实施例中,所述模制的塑性本体可比内层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可由塑性材料和/或任何其它适宜的材料(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,对齐矩阵1740可组装至内层1712,并且随后缝钉腿1721可插穿对齐矩阵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缝钉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可放置于包括内层1712、对齐矩阵1740、和缝钉1720的子组件周围。作为另外一种选择,外层1711可放置于包括内层1712及对齐矩阵1740的子组件周围,其中缝钉1720可随后插穿外层1711、对齐矩阵1740、和内层1712。在任一情形中,作为上文的结果,内层1712、对齐矩阵1740、和/或外层1711能够将缝钉1720保持就位,直至和/或在缝钉1720以上述方式被砧座变形。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缝钉1720保持就位,以及在钉仓1700被植入之后沿缝钉线固定组织。在至少一个实施例中,例如缝钉1720可被固定于对齐矩阵1740内而不被嵌入内层1712和/或外层1711中。
现在参见图99-105,在各种实施例中,可通过压缩内层1812、将缝钉(例如,缝钉1820)插入内层1812中、并用外层1811包裹内层1812来组装钉仓(例如,钉仓1800)。主要参见图99,可压缩的内层1812被示为包括被限定在其中的多个缝钉腔1815,然而也可设想出如上所述其中内层1812不包括缝钉腔的其它实施例。现在参见图100,可压缩的内层1812可定位在传送板1850与支撑板1860之间并被压缩于传送板1950的压缩表面1852与支撑板1860的压缩表面1862之间。如图100所示,内层1812的顶面及底部表面可朝向彼此而被压缩,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约0.06”至约0.08”之间的高度或厚度。同样如图100所示,传送板1850还可包括位于多个缝钉井1853内的多个缝钉(例如缝钉1820)。另外,传送板1850还可包括多个驱动器1851,所述多个驱动器1851能够将缝钉1820向上推出缝钉井1853外。现在参见图101,可利用驱动器1851将缝钉1820的缝钉腿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能够使得当缝钉1820从传送板1850的缝钉井1853中被完全部署时,驱动器1851的顶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101所示,支撑板1860可包括多个容纳孔1861,所述多个容纳孔1861能够在缝钉腿1821被推动穿过内层1812之后,容纳孔1861容纳缝钉腿1821或至少缝钉腿1821的末端。在其中内层1812已被压缩至短于缝钉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,因此当缝钉1820从缝钉井1853中被完全射出时,缝钉腿1821可从压缩的内层1812的顶面突起。在某些其它实施例中,内层1812可被压缩至高于缝钉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102,在缝钉1820被插入内层1812中之后,支撑板1860可远离传送板1850而行进,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缝钉1820的高度且缝钉1820的缝钉腿1821不再从内层1812的顶面突起。在各种情形中,容纳孔1861能够将缝钉腿1821保持就位,至少直到支撑板1860已运动至足够远而使腿部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再次伸展时帮助内层1812内的缝钉1820保持相对对齐。在各种情形中,内层1812及位于其中的缝钉1820可包括子组件1801,现在参见图103,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可包括被限定在其中的腔1802,腔1802能够在其中容纳子组件1801。在各种情形中,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104,一旦子组件1801完全位于外层1811内,则外层1811可被密封。在各种实施例中,可利用对外层1811的一部分施加热能来密封外层1811。更具体地讲,在至少一个实施例中,外层1811可由塑性材料构成,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105,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106和图107,在各种实施例中,钉仓附接部可包括钉仓通道(例如钉仓通道1930),该钉仓通道能够在其中容纳钉仓(例如钉仓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,侧向宽度1903相同于和/或宽于支撑壁1940与1941之间所限定的侧向间隙,使得钉仓1900的可压缩并可植入的仓体1910可牢固地配合于壁1940与1941之间。在某些其它实施例中,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的至少一部分可由挠性材料(例如弹性体材料)构成。主要参见图106,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和从刚性部分1933向上延伸的挠性部分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可由一种或多种可压缩的层(例如,第一层1911及第二层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的侧部可侧向地延伸。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的至少一部分由挠性侧壁构成的实施例中,挠性侧壁能够侧向地屈曲并容许仓体1910的侧部侧向地伸展,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延伸。现在参见图107,在任何情形中,钉仓通道2030可包括侧壁2040和2041,所述侧壁2040和2041可完全由挠性材料(例如弹性体材料)构成。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/或压配结构而固定于狭槽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于狭槽2033中。在至少一个实施例中,侧壁2040和2041可在使用期间从底部支撑表面2031拆卸。在任何情形中,当仓体2010中植入有缝钉2020时,可压缩并可植入的仓体2010可从侧壁2040和2041拆卸和/或脱离。
现在参见图108,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可包括可压缩并可植入的仓体2110以及位于仓体2110中的多个缝钉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,所述钉仓2100可抵靠底部支撑表面2130而定位。在至少一个实施例中,如图108所示,钉仓2100可包括第一端部2105和第二端部2106,所述第一端部可定位在钉仓通道2130的远端2135中,所述第二端部2106可定位在钉仓通道2130的近端2136中。在各种实施例中,钉仓通道2130的远端2135可包括至少一个远端保留结构(例如保留壁2137);相似地,近端2136可包括至少一个近端保留结构(例如保留壁2138)。在至少一个此类实施例中,远端保留壁2137与近端保留壁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88和图89,在各种实施例中,钉仓(例如,钉仓1200)可包括平的或至少基本上为平的组织接触表面1219。在至少一个此类实施例中,钉仓1200的钉仓本体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108,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108和图109,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109所示。当砧座2140处于闭合位置时,砧座2140能够对钉仓2100的第一端部2105的压缩程度大于第二端部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。更具体地讲,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。更具体地讲,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108,在各种实施例中,位于钉仓2100与砧座2140之间的组织T可不具有遍及其中的恒定的厚度。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2143,并使砧座2140朝钉仓2100旋转,如图109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。更具体地讲,当较薄的组织T可与钉仓2100的较高的高度相关且较厚的组织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108和图109,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/或保留结构,所述一个或多个对齐和/或保留结构能够确保钉仓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/或保留结构,所述一个或多个对齐和/或保留结构能够容许钉仓2100沿不止一个方向定位在钉仓通道2130内。现在参见图110,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可定位在钉仓通道2130的近端2136中且第二端部2106可定位在远端2135中。因此,在各种实施例中,较低高度的钉仓2100可邻近远侧保留壁2137定位,而较高高度的钉仓2100可邻近近侧保留壁2138定位。在至少一个此类实施例中,钉仓2100可被适宜地设置以对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加紧压力。在各种实施例中,钉仓2100例如可在钉仓通道2130内被选择性地取向。在至少一个此类实施例中,钉仓2100的对齐和/或保留结构可为对称的,并且外科医生可沿例如图108和图110所示的方向可在钉仓通道2130内对钉仓2100进行取向。
对上文进进一步描述,可植入的仓体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。再次参见图Z,在各种实施例中,钉仓2100可包括定位在其中的多个缝钉2120。在使用中,如上所述,当砧座2140运动至闭合位置时,缝钉2120可变形。在某些实施例中,每一缝钉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,可例如从缝钉基部的底部到缝钉最高腿部的顶部或末端来测量缝钉的高度。
在各种实施例中,钉仓内的缝钉可具有不同的缝钉高度。在至少一个此类实施例中,钉仓可包括具有第一缝钉高度的第一组缝钉和具有第二缝钉高度的第二组缝钉,所述第一组缝钉被定位在可压缩的仓体的第一部分中,并且第二组缝钉被定位在可压缩的仓体的第二部分中。在至少一个实施例中,第一缝钉高度可高于第二缝钉高度,并且第一组缝钉可被定位在钉仓2100的第一端部2105中,而第二组缝钉可被定位在第二端部2106中。作为另外一种选择,较高的第一组缝钉可被定位在钉仓2100的第二端部2106中,而较低的第二组缝钉可被定位在第一端部2105中。在某些实施例中,可利用多个缝钉组,其中每一组各自具有不同的缝钉高度。在至少一个此类实施例中,具有中间缝钉高度的第三组可在第一组缝钉与第二组缝钉之间被定位在仓体2110中。在各种实施例中,钉仓中的缝钉排内的每一缝钉可分别包括不同的缝钉高度。在至少一个实施例中,缝钉排内的最高缝钉可被定位在缝钉排的第一端部上,并且最低的缝钉可被定位在该缝钉排的相对端上。在至少一个此类实施例中,位于最高缝钉与最低缝钉之间的缝钉可被设置成使得缝钉高度例如在最高缝钉与最低缝钉之间下降。
现在参见图111,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可包括可压缩并可植入的仓体2210以及被定位在仓体2210中的多个缝钉(例如缝钉2220a及缝钉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中的多个缝钉支撑狭槽(例如支撑狭槽2232a和2232b)。在至少一个此类实施例中,钉仓2200可包括缝钉2220a的两个外侧行和缝钉2220b的两个内侧行,其中支撑狭槽2232a能够支撑缝钉2220a,并且支撑狭槽2232b能够支撑缝钉2220b。参见图111和图112,砧座2240可包括被限定在其中的多个缝钉成形凹坑2242,所述多个缝钉成形凹坑2242能够当砧座2240朝钉仓2200运动时所述多个缝钉成形凹坑2242容纳缝钉2220a和2220b并使其变形。在至少一个此类实施例中,支撑狭槽2232a的底部表面可与缝钉成形凹坑2242的顶面相距第一距离2201a,而支撑狭槽2232b的底部表面可与缝钉成形凹坑2242的顶面相距第二距离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,缝钉2220a的外侧行及缝钉2220b的内层行可变形至不同的成形高度。在各种情形中,变形至不同成形高度的缝钉可对所缝合的组织T施加不同的夹紧压力或力。除上文所述之外,缝钉可在起初具有不同的未成形缝钉高度。再次参见图111,在至少一个此类实施例中,外层缝钉2220a的初始未成形高度可大于内侧缝钉2220b的初始未成形高度。如图111和图112所示,未成形高度低于外侧缝钉2220a的内侧缝钉2220b也可具有低于外侧缝钉2220b的成形高度。在各种可供选择的实施例中,内侧缝钉2220b可具有高于外侧缝钉2220a的未成形高度而具有低于外侧缝钉2220a的变形缝钉高度。
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(如图112所示),以便压缩仓体2210并使缝钉2220a及2220b变形。在某些实施例中,包括图111和图112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。更具体而言,砧座2240可包括狭槽部2249,钉仓通道2230可包括狭槽部2239,并且钉仓2200可包括狭槽部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2249、狭槽部2239、和狭槽部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被闭合且缝钉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,切割构件可以与缝钉变形过程不相关的方式运动。在某些实施例中,切割构件可在缝钉变形的同时推进。在任何情形中,在至少一个实施例中,切割构件能够沿位于缝钉2220b形成的内侧行之间的路径切开组织。
在各种实施例中,如图112所示,内侧缝钉2220b可被成形至低于外侧缝钉2220a的高度,其中内侧缝钉2220b可对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力。在至少一个此类实施例中,内侧缝钉2220b所形成的较大夹紧压力或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,而外侧缝钉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111和图112,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(例如支撑材料2260)。在至少一个此类实施例中,缝钉2220a、2220b的腿部能够当钉仓2200被砧座2240压缩并随后接触砧座2240中的缝钉成形凹坑2242时,缝钉2220a、2220b的腿部切开支撑材料2260和/或穿过支撑材料2260中的孔。当缝钉2220a、2220b的腿部变形时,所述腿部可再次接触和/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111和图112,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113,在各种实施例中,类似于图111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的可压缩并可植入的本体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可由水不可渗透的材料构成。在各种实施例中,外层2311可围绕缝钉2220a、2220b延伸并可分别位于缝钉2220、2220b与支撑狭槽2232a、2232b之间。现在参见图114,在各种实施例中,类似于图111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的可压缩并可植入的仓体2410可包括内层2412及外层2411;然而,在至少一个实施例中,仓体2410中可不包括切割构件狭槽。在至少一个此种实施例中,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115,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、以及定位于钉仓通道2530中的钉仓2500。与上文相似,钉仓2500可包括可压缩并可植入的仓体2510、缝钉2220a的外侧行、以及缝钉2220b的内侧行。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中的缝钉支撑狭槽2532。砧座2540可包括阶梯式表面2541以及限定在阶梯式表面2541中的多个缝钉成形凹坑(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。更具体地讲,在至少一个实施例中,砧座2540可包括朝钉仓2500延伸的阶梯2548,其中阶梯2548可包括阶梯高度,所述阶梯高度等于或至少基本上等于从仓体2510延伸的阶梯2508的阶梯高度。在至少一个此类实施例中,作为上文的结果,例如可压缩仓体2510可被捕获在第一缝钉2220a中的量可不同于可压缩仓体2510可被捕获在第二缝钉2220b中的量。
现在参见图116,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可包括可压缩并可植入的仓体2610,仓体2610包括内层2612、外层2611、以及定位在仓体2610中的多个缝钉(例如缝钉2220a和2200b)。在各种实施例中,砧座2640可在表面2641中包括多个缝钉成形凹坑2642,并且钉仓通道2530可包括限定在支撑表面2531中的多个缝钉成形狭槽2532。如图116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,其中每一成形凹坑2642可被定位成与相对的且相对应的缝钉支撑狭槽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所包括的缝钉可具有相同或至少基本上相同的初始未成形缝钉高度以及相同或至少基本上相同的成形缝钉高度。在某些其它实施例中,外侧缝钉排可包括缝钉2220a且内侧缝钉排可包括缝钉2220b,其中如上所述,缝钉2220a和2220b可具有不同的未成形缝钉高度。当砧座2640朝钉仓2600运动至闭合位置时,缝钉2220a和2220b可被成形为使缝钉2220a和2220b具有相同的或至少基本上相同的成形缝钉高度。在至少一个此种实施例中,作为上文的结果,成形的外侧缝钉2220a及内侧缝钉2220b中可容纳有相同的或至少基本上相同的量的可压缩仓体2610;然而,当外侧缝钉2220a具有高于内侧缝钉2220b的未成形缝钉高度然而可具有相同的成形缝钉高度时,例如,外侧缝钉2220a中所产生的夹紧压力可大于内侧缝钉2220b中所产生的夹紧压力。
现在参见图117,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、以及定位于钉仓通道2530中的钉仓2700。与上文相似,钉仓2700可包括可压缩并可植入的仓体2710,仓体2710包括内层2712、外层2711、以及定位在仓体2710中的多个缝钉(例如缝钉2220a和2220b)。在至少一个实施例中,仓体2710的厚度可穿过其宽度而发生变化。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向下比降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中的内侧缝钉排可包括较高的缝钉2220a,并且外侧缝钉排可包括较低的缝钉2220b。在至少一个实施例中,较高的缝钉2220a可被定位在较厚的中心部2708中和/或与中心部2708相邻,而缝钉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,作为上文的结果,较高的缝钉2220a可比较低的缝钉2220b捕获更多的可植入仓体2710的材料。这种情形可使缝钉2220a比缝钉2220b对组织T施加更大的夹紧压力。在某些实施例中,尽管较高的缝钉2220a中可比较低的缝钉2220b捕获更多的仓体2710的材料,然而由于缝钉成形凹坑2742a和2742b具有倾斜的结构,因此较高的缝钉2220a可比较低的缝钉2220b具有更高的成形缝钉高度。可利用这种考虑因素在缝钉2220a和2220b所捕获的组织中达到期望的夹紧压力,其中作为结果,例如缝钉2220a中的夹紧压力可大于、小于、或等于缝钉2220b对组织施加的夹紧压力。在图117所示端部执行器的各种可供选择的实施例中,较低的缝钉2220b可定位在仓体2710的较厚的中心部2708中和/或邻近中心部2708,并且较高的缝钉2220a可定位在较薄的侧部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缝钉排,然而钉仓2700可包括额外的缝钉排,例如位于内侧缝钉排与外侧缝钉排之间的缝钉排。在至少一个此类实施例中,例如中间缝钉排的未成形缝钉高度可介于缝钉2220a的未成形缝钉高度与缝钉2220b的未成形缝钉高度之间,并且中间缝钉排的成形缝钉高度可介于缝钉2220a的成形缝钉高度与缝钉2220b的成形缝钉高度之间。
现在参见图118,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、以及定位于钉仓通道2530中的钉仓2800。与上文相似,钉仓2800可包括可压缩并可植入的仓体2810,仓体2810包括内层2812、外层2811、以及定位在仓体2810中的多个缝钉(例如缝钉2220a和2220b)。在至少一个实施例中,仓体2810的厚度可穿过其宽度而发生变化。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向上比降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中的外侧缝钉排可包括较高的缝钉2220a,并且内侧缝钉排可包括较低的缝钉2220b。在至少一个实施例中,较高的缝钉2220a可被定位在较厚的侧部2809中和/或与侧部2809相邻,而缝钉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,作为上文的结果,较高的缝钉2220a可比较低的缝钉2220b捕获更多的可植入仓体2810的材料。
如上文参照图111的实施例所述,例如,钉仓通道2230可包括阶梯式支撑表面2231,阶梯式支撑表面2231能够相对于砧座2240将缝钉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中的阶梯可通过例如研磨操作而形成于支撑表面2231中。现在参见图119,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。更具体地讲,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的缝钉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而定位。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能够将缝钉2220a和2220b分别支撑在不同高度处。与上文相似,插入件2935可包括被限定在其中的刀狭槽2939,刀狭槽2939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,而在其它实施例中,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固定于钉仓通道2930中。
现在参见图120,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中的可压缩并可植入的钉仓3000。与上文相似,砧座3040可包括被限定在其中的多个缝钉成形凹坑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可包括被限定在其中的多个缝钉支撑狭槽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中的多个缝钉(例如缝钉3020a及3020b)。在至少一个实施例中,缝钉3020a的未成形缝钉高度可高于缝钉3020b的未成形缝钉高度。在各种实施例中,第一层3011可由第一可压缩材料构成,并且第二层3012可由第二可压缩材料构成。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,而在某些其它实施例中,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。在某些其它实施例中,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。在某些其它实施例中,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120,在各种实施例中,钉仓3000的第二层3012可穿过其宽度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的厚度可穿过其宽度而发生变化。在至少一个此类实施例中,第一层3011可包括一个或多个阶梯3008,阶梯3008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120,较低的缝钉3020b可定位在阶梯3008(即仓体3010的较厚部分)中或与阶梯3008对齐,并且较高的缝钉3020a可定位在仓体3010的较薄部分中或与所述较薄部分对齐。在各种实施例中,作为仓体3010的较厚部分及较薄部分的结果,仓体3010的沿缝钉3020b形成的内侧行的刚度可大于沿缝钉3020a形成的外侧行的刚度。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,刀狭槽3003能够在其中可滑动地容纳切割构件。
现在参见图121,在各种实施例中,钉仓3100可包括可压缩并可植入的仓体3110,仓体3110包括单层可压缩材料以及定位于仓体3110中的多个缝钉(例如,缝钉3020b)。在至少一个实施例中,仓体3110的厚度可穿过其宽度而变化。在至少一个此类实施例中,仓体3110可包括沿仓体3110的边延伸的台阶3108。现在参见图122,在各种实施例中,钉仓3200可包括可压缩并可植入的仓体3210,该仓体3210包括单层可压缩材料以及定位在仓体3210中的多个缝钉(例如缝钉3020b)。在至少一个实施例中,仓体3210的厚度可穿过其宽度而变化。在至少一个此类实施例中,仓体3210可包括沿仓体3210的中心部延伸的台阶3208。现在参见图123,在各种实施例中,钉仓3300可包括可压缩并可植入的仓体3310,其中与上文相似,仓体3310的厚度可穿过其宽度而变化。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的厚度可由拱形或弯曲的外形限定并可包括拱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124,在各种实施例中,钉仓3400可包括可压缩并可植入的仓体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125,在各种实施例中,钉仓3500可包括可压缩并可植入的仓体3510以及位于仓体3510中的多个缝钉3520。可植入的仓体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,每一缝钉3520可包括基部3522和从基部3522延伸的一个或多个可变形腿部3521。在各种实施例中,每一腿部3521可包括嵌入第一内层3511中的末端3523,另外缝钉3520的每一基部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,使得只有外层3511被缝钉3520刺穿之后药物才会流出钉仓本体3510。更具体地讲,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朝缝钉末端3523并至少部分地在缝钉末端3523下方向下运动,使得末端3523使外层3511破裂或刺穿外层3511。在缝钉腿3521使外层3511破裂之后,至少一种药物M可流出围绕缝钉腿3521的仓体3510。在各种情形中,仓体3510的额外压缩可将额外的药物M挤出仓体3510,如图126所示。
再次参见图125,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层,所述包裹层能够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中的这种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/或更具挠性。在至少一个此类实施例中,第一内层3512可包括被限定在其中的多个孔或空隙3508,并且第二内层3513可包括被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125及图126,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可由第一可生物吸收的材料构成,第二内层3513可由第二可生物吸收的材料构成,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,这种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,因此这种速率可被表达成平均速率以解释这种可变性。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125和图126,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、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可在缝钉线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中的一者或多者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127及图128,在各种实施例中,钉仓(例如,钉仓3600)可包括仓体3610,仓体3610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中的多个缝钉(例如缝钉3620)。在至少一个此类实施例中,例如每一缝钉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部3621。在使用中,对上文进行进一步描述,钉仓本体3610的顶面3619可被砧座向下推动,直至缝钉腿3621穿透顶面3619及靶组织并接触砧座为止。在缝钉腿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。在各种情形中,缝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可从第二层3612上拆卸。在其中第三层3613包括具有可植入品质的材料的实施例中,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,其中作为结果,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,其中作为结果,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129和图130,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3710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可包括多个缝钉容纳狭槽或切口3709,所述多个缝钉容纳狭槽或图案3709可分别能够在其中容纳缝钉3620的至少一部分(例如缝钉基部3622)。在某些实施例中,缝钉3620能够在缝钉容纳狭槽3709中滑动,或换言之,第三层3713能够例如当钉仓3700抵靠靶组织而定位并被砧座压缩时,第三层3713相对于缝钉3620滑动。在至少一个实施例中,容纳狭槽3709能够使缝钉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,作为上文的结果,当缝钉3620变形时,缝钉3620可不将第三层3713的一部分捕获在其中,如图129和图130所示。在某些其它实施例中,缝钉容纳狭槽3709的邻近第二层3712的末端可由第三层3713的一部分闭合,因此当缝钉3620变形时,第三层3713的至少一部分可被捕获在缝钉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3708能够容许第三层3713以两部分或更多部分从第二层3712被移除,如图129所示。在图129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可沿位于第一缝钉排与第二缝钉排中间的线设置。
再次参见图129及图130,在各种实施例中,缝钉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的侧壁能够接触缝钉腿3621并将缝钉腿3621可释放地保持于定位上。在某些实施例中,尽管未示出,然而第三层3713可包括围绕缝钉线内所有缝钉的细长狭槽。在至少一个此类实施例中,包括四个缝钉排的钉仓例如可包括与钉仓底层中的每一缝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129和图130,在至少一个实施例中,第一层3711和第二层3712可被捕获在缝钉3620内并可与缝钉3620一起被植入,而第三层3713可任选地从钉仓3700中被移除或拆卸。在各种情形中,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将钉仓的一部分拆卸并移除的情形中,所拆卸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,仓体可包括不止一个可被移除的层。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131,在各种实施例中,钉仓(例如,钉仓3800)可包括仓体3810,仓体3810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可通过挠性铰链(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可包括自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中的多个可变形腿部3821。在至少一个此类实施例中,腿部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,腿部3821可至少部分地从内层3812突起。当可压缩的仓体3810被压缩时,在使用中,腿部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可包括被限定在其中的孔(例如孔3808),所述孔能够容纳缝钉腿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132,在各种实施例中,与钉仓3800相似,钉仓3900可包括仓体3910,仓体3910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中的多个可变形腿部3921。在某些实施例中,每一可变形腿部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钩3923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能够自内层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,以使倒钩自内层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,腿部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部3921的至少一部分重叠注塑。
现在参见图133-137,在各种实施例中,钉仓(例如,钉仓4000)可包括仓体4010,仓体4010包括可压缩的第一层4011、第二层4012、以及定位于仓体4010中的多个缝钉4020。参见图135,在某些实施例中,每一缝钉4020可包括基部4022和从基部4022延伸的至少一个可变形腿部4023。参见图133,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/或缝钉4020的基部4022可抵靠钉仓通道4030定位。现在参见图134,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4060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。每一脱脂棉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4062能够容纳延伸穿过其中的缝钉腿4021,如图135和图136所示。每一脱脂棉4060还可包括被限定在其中的容纳狭槽4063,该容纳狭槽能够容纳缝钉4020的基部4022。再次参见图134,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在所需位置处从脱脂棉支撑框架4061被拆卸。相似地,参见图136,一个或多个脱脂棉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能够使缝钉4020变形。当缝钉4020变形时,每一缝钉4020的缝钉腿4021可将组织T、第一层4011的一部分、以及脱脂棉4060捕获在变形的缝钉内。当钉仓通道4030远离已植入的钉仓4060而运动时,例如脱脂棉支撑框架4061可从脱脂棉4060拆卸和/或各脱脂棉4060可自彼此拆卸。在某些情形中,当缝钉4020被砧座4040以上述方式变形时,脱脂棉4060可从框架4061和/或彼此拆卸。
在本文所述的各种实施例中,当砧座运动到闭合位置时,钉仓的缝钉可由砧座完全成形。现在参见图138-141,在各种其它实施例中,钉仓(例如钉仓4100)的缝钉可通过运动至闭合位置的砧座以及使缝钉朝闭合的砧座运动的缝钉驱动器系统而变形。钉仓4100可包括可压缩的仓体4110,可压缩的仓体4110可例如由泡沫材料以及至少部分地位于可压缩仓体4110内的多个缝钉4120构成。在各种实施例中,缝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内的多个缝钉驱动器4162、以及钉仓盘4180,该钉仓盘能够将缝钉驱动器4162保持在驱动器夹持器4160中。在至少一个此类实施例中,缝钉驱动器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缝钉驱动器4162。在各种实施例中,缝钉4120可由缝钉驱动器4162支撑在狭槽4163内,其中在至少一个实施例中,当缝钉4120及缝钉驱动器4162处于其未击发位置时,缝钉4120可完全位于狭槽4163中。在某些其它实施例中,当缝钉4120及缝钉驱动器4162处于其未击发位置时,缝钉4120的至少一部分可穿过狭槽4163的开口端4161向上延伸。现在主要参见图139,在至少一个此类实施例中,缝钉4120的基部可定位在驱动器夹持器4160内,并且缝钉4120的末端可嵌入可压缩的仓体4110内。在某些实施例中,缝钉4120的大约三分之一的高度可定位在驱动器夹持器4160内,并且缝钉4120的大约三分之二的高度可定位在仓体4110内。参见图138A,在至少一个实施例中,例如钉仓4100还可围绕仓体4110及驱动器夹持器4160而包括水不可渗透的包裹层或膜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的仓体4110。在某些实施例中,当砧座处于其闭合位置时,砧座可不接触缝钉4120。在某些其它实施例中,当砧座运动至其闭合位置时,砧座可接触缝钉4120的腿部并至少部分地使缝钉4120变形。在两种情形中的任一情形中,钉仓4100还可包括一个或多个橇4170,所述一个或多个橇4170可在钉仓4100内沿纵向推进,使得橇4170可随后接合缝钉驱动器4162并使缝钉驱动器4162及缝钉4120朝砧座运动。在各种实施例中,橇4170可在钉仓盘4180与缝钉驱动器4162之间滑动。在其中砧座的闭合已使缝钉4120的成形过程开始的实施例中,缝钉4120朝砧座向上运动可完成成形过程并使缝钉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缝钉4120变形的实施例中,缝钉4120朝砧座向上运动可开始并完成成形过程并使缝钉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,橇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的远端中的缝钉4120完全成形之前,位于钉仓4100的近端中的缝钉4120完全成形。参见图140,在至少一个实施例中,橇4170可分别包括至少一个成角度的或倾斜的表面4711,所述至少一个成角度的或倾斜的表面4711能够在缝钉驱动器4162下方滑动并如图141所示提升缝钉驱动器4162。
在各种实施例中,对上文进行进一步描述,缝钉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。在缝钉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而运动。在各种情形中,仓盘4180可以固定方式接合钉仓通道4130,其中作为结果,当钉仓通道4130被拉离已植入的仓体4110时,仓盘4180可自可压缩的仓体4110拆卸。再次参见图138,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,可压缩的仓体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/或橇4170可保持在仓盘4180中。在某些其它实施例中,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可附接到缝钉4120,使得驱动器4162部署有缝钉4120。在至少一个此类实施例中,每一驱动器4162可包括例如能够容纳缝钉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缝钉基部。
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/或橇4170可从仓盘4180中被射出。在至少一个此类实施例中,橇4170可在仓盘4180与驱动器夹持器4160之间滑动,使得当橇4170推进以向上驱动缝钉驱动器4162及缝钉4120时,橇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/或橇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,橇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而推动橇4170。在此类实施例中,橇4170可不从仓盘4180中被射出并可与外科缝合器保持在一起,而在橇4170未附接到驱动棒的其它实施例中,橇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,作为在砧座闭合时缝钉被至少部分地变形的结果,可使用较高的缝钉(例如具有约0.18”缝钉高度的缝钉),例如其中约0.12”的缝钉高度可被定位在可压缩层4110中,并且其中可压缩层4110可具有约0.14”的未压缩高度。
现在参见图142-145,在各种实施例中,钉仓(例如,钉仓4200)可包括可压缩的仓体4210、位于可压缩仓体4210中的多个缝钉4220、以及多个挠性的横向支撑构件4234。现在参见图143,在各种实施例中,钉仓4200可定位在砧座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并至少部分地使缝钉4220变形时,如图144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可从仓体4210拆卸,如图144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缝钉4220变形,其中可通过如图145所示穿过钉仓4200推进一个或多个橇4270来完成缝钉4220的成形。现在参见图147和图148,在各种实施例中,橇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/或可压缩的仓体4210而推进。在某些实施例中,切割构件4280可包括凸轮构件4282,凸轮构件4282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,作为上文的结果,缝钉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,橇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147和图148,在各种实施例中,橇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,橇4270可被容纳在钉仓4200中,并且切割构件4280可被击发棒4281推进至钉仓4200中,使得切割构件4280接合橇4270并朝远侧推进橇4270。在某些实施例中,各橇4270可彼此连接。在两种情形中的任一种情形中,每一橇4270可包括成角度的表面或凸轮4271,该成角度的表面或凸轮4271能够提升在缝钉排中对齐的缝钉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147和图148,在至少一个实施例中,每一缝钉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重叠注塑到缝钉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,例如这种冠部4229能够由橇4270直接驱动。更具体地讲,在至少一个实施例中,缝钉4220的冠部4229能够使得在橇4270的成角度的表面4271与冠部4229之间未定位有缝钉驱动器的情况下,成角度的表面4271可在冠部4229下方直接接触冠部4229而滑动。在此类实施例中,每一冠部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橇4270的成角度的表面4271接合,使得当橇4270在缝钉4220下方滑动时,协作的成角度表面可向上驱动缝钉4220。
现在参见图146,在各种实施例中,钉仓(例如,钉仓4300)可包括可压缩的本体4310以及定位于可压缩的本体4310中的多个缝钉4320。与上文相似,钉仓4300可包括挠性的侧向支撑件4334,该挠性的侧向支撑件可附接到钉仓通道和/或粘附到可压缩的本体4310。除上文所述者之外,挠性的侧向支撑件4334可由一个或多个支杆或连接构件4335连接到一起,所述一个或多个支杆或连接构件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过早地从仓体4310拆卸。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橇(例如橇4270),以便使缝钉4320抵靠砧座而成形。橇4270可引导切割刀刃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的缝钉4320完全成形或至少成形至期望高度为止。在各种情形中,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内的缝钉4320的侧向运动。在这种情形中,连接构件4335可将缝钉4320保持就位,直至缝钉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可由可植入的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从侧向支撑件4334拆卸之后,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可由可植入的材料构成,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的复合物等挠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的材料薄片。在某些实施例中,钉仓可包括延伸穿过仓体4310的顶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149,在各种实施例中,钉仓可包括缝钉(例如,缝钉4420),所述缝钉可包括被插入冠部分中的线材部。在至少一个实施例中,线材部可由金属(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,每一缝钉4420的线材部可包括基部4422和从基部4422延伸的可变形腿部4421,其中每一缝钉4420的冠部分可包括冠部4429,冠部4429能够在其中容纳基部4422的至少一部分。现在参见图150A-150C,为组装每一缝钉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能够将腿部4421引导至基部腔4427中。线材部还可被插入冠部4429中,使得腿部4421离开基部腔4427且线材部的基部4422进入基部腔4427中。在至少一个此类实施例中,基部腔4427能够使得当基部4422进入基部腔4427时,线材部在冠部4429中旋转,以使缝钉腿4421指向向上的或至少基本上向上的方向。再次参见图149,在各种实施例中,冠部4429可包括离孔4425,离孔4425能够在其中容纳缝钉腿4421。
在各种实施例中,对上文进行进一步描述,外科缝合器可包括橇4470,橇4470能够横贯钉仓4400和钉仓通道4430并朝砧座行进仓体4410内所容纳的缝钉4420。在各种情形中,橇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和缝钉4420。在某些情形中,橇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,则橇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的情况下防止橇4470再次朝远侧推进。再次参见图149,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橇4470朝远侧运动。更具体地讲,橇4470能够除非橇4470由提升结构4428至少部分地向上提升超过肩部4439,否则橇4470邻接肩部4439,提升结构4428例如在钉仓4400内的最近侧缝钉4420之间延伸。换言之,当新的钉仓4400中不存在最近侧缝钉4420时,橇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,橇4470无法在仓通道4430中推进。
现在参见图151,对上文进行进一步描述,钉仓(例如,钉仓4500)可被定位在钉仓通道4530中并可包括可压缩的仓体4510、定位于仓体4510中的多个缝钉4520、以及仓盘或保持器4580。在各种实施例中,可压缩的仓体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。在某些其它实施例中,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可协作地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,缝钉4520可由仓盘4580支撑,其中仓盘4580可包括能够支撑缝钉4520的一个或多个缝钉支撑通道。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可在缝钉4520形成的第一行与缝钉4520形成额第二行之间沿纵向延伸穿过钉仓4500。
在各种实施例中,仓体4510和/或仓盘4580可包括协作保留结构,所述协作保留结构可在仓盘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能够可拆卸地联接到仓通道4530,使得在钉仓4500被砧座4540压缩且缝钉4520变形之后,仓盘4580可从仓通道4530拆卸并可与仓体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能够可拆卸地联接到仓盘4580,使得在钉仓4500被砧座4540压缩且缝钉4520变形之后,仓体4510可从仓盘4580拆卸。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与缝钉4520中间的缝钉驱动器,使得当击发机构朝远侧滑动时,缝钉驱动器及缝钉4520可朝砧座被向上驱动。在至少一个此类实施例中,缝钉驱动器可至少部分地嵌入可压缩的仓体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内的最近侧缝钉和/或任何其它适宜的缝钉可包括提升表面,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。如果外科医生看见第一颜色,则外科医生可知道钉仓通道4530中存在未击发的仓4500;如果外科医生看见第二颜色,则外科医生可知道钉仓通道4530中存在击发的仓4500且需要将剩余的仓盘4580移除;且如果外科医生看见第三颜色,则外科医生可知道仓通道4530中未保留有钉仓4500的任何部分。
现在参见图152,在各种实施例中,钉仓(例如,钉仓4600)可包括可压缩并可植入的仓体4610以及定位于仓体4610中的多个缝钉4620。仓体4610可包括外层4611和内层4612。在某些实施例中,内层4612可包括被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可包括波纹形或蜂巢构型的点阵,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可关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被压垮至大的挠曲量并塌缩或弯曲。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亚层4612a构成。在至少一个实施例中,每一亚层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亚层4612a的交替的沟与脊对齐。在至少一个此类实施例中,第一亚层4612a的沟可被定位成与第二亚层4612a的脊相邻;相似地,第一亚层4612a的脊可被定位成与第二亚层4612a的沟相邻。在各种实施例中,相邻的亚层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153示出在仓体4610已塌缩且缝钉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154-156,在各种实施例中,钉仓(例如,钉仓4700)可包括可压缩并可植入的仓体4710以及定位于仓体4710中的多个缝钉4720。与上文相似,仓体4710可包括外层4711和内层4712,其中内层4712可包括多个亚层4712a。同样与上文相似,每一亚层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,缝钉4720可在多个缝钉排中对齐,所述多个缝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152和图153,在各种可供选择的实施例中,仓体4600中所容纳的缝钉4620可沿轴线延伸,所述轴线横跨或垂直于由亚层4612a的沟及脊所限定的轴线。再次参见图154-156,缝钉4720可延伸穿过沟4717和脊4718,其中缝钉4720与亚层4712a之间的摩擦力可将缝钉4720保持在仓体4710中。在某些实施例中,所述多个亚层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缝钉4720保持在直立的取向、和/或将缝钉4720保持成相对于彼此如图154和图155所示对齐。图156示出在仓体4710塌缩且缝钉4720变形以抵靠仓体4710捕获并保持组织T之后的钉仓4700。
再次参见图154-156,在各种实施例中,当仓体4710被压缩时,仓体4710可弹性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在每一亚层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4715塌缩或至少基本上塌缩。在各种情形中,当从仓体4710上移除压缩力或压力之后,所述仓体或仓体的至少某些部分可弹性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,相邻亚层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,亚层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157,在某些实施例中,钉仓(例如钉仓4800)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、蜂巢构型的点阵,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158-160,在各种实施例中,钉仓(例如,钉仓4900)例如可包括仓体4910,仓体4910包括外层4911以及定位于外层4911的顶部与底部之间的多个可塌缩元件4912。主要参见图158和图159,钉仓4900还可包括多个缝钉4920,其中每一缝钉4920可被定位在可塌缩元件4912中。更具体地讲,每一可塌缩元件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4915,所述腔能够容纳缝钉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,每一可塌缩元件4912的第二部分4912b可塌缩至对应的第一部分4912a中;相似地,每一可塌缩元件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中的缝钉4920可变形,如图160所示。在各种实施例中,每一可塌缩元件4912的第二部分4912b可带有摩擦地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159)中的保留力,则第一部分4912a和第二部分4912b可开始相对于彼此进行滑动。相似地,每一可塌缩元件4912的第三部分4912c可带有摩擦地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159)中的保留力,则第二部分4912b和第三部分4912c可开始相对于彼此进行滑动。
在许多本文所述的实施例中,钉仓中可包括多个缝钉。在各种实施例中,这种缝钉可由被变形为基本上U形构型并具有两个缝钉腿的金属线材构成。可设想出其中缝钉可包括不同构型(例如被接合在一起并具有三个或更多个缝钉腿的两个或更多个线材)的其它实施例。在各种实施例中,用于形成缝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,缝钉线材可包括任何其它适宜的横截面,例如正方形和/或矩形的横截面。在某些实施例中,缝钉可由塑料线材构成。在至少一个实施例中,缝钉可由涂覆有塑料的金属线材构成。在各种实施例中,除缝钉之外或作为缝钉的替代,仓可包括任何适宜类型的紧固件。在至少一个此类实施例中,这种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,并且砧座可包括多个第二紧固件部;当砧座抵靠钉仓而被压缩时,第二紧固件部连接到第一紧固件部。在某些实施例中,如上所述,可在钉仓内推进橇或驱动器以便完成缝钉的成形过程。在某些实施例中,可在砧座内推进橇或驱动器,以便使一个或多个成形构件向下运动至与相对的钉仓及缝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,钉仓可包括存储在其中的四个缝钉排。在至少一个实施例中,所述四个缝钉排可被设置成两个内侧缝钉排和两个外侧缝钉排。在至少一个此类实施例中,内侧缝钉排及外侧缝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,内侧缝钉排和外侧缝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,钉仓可不包括切割构件狭槽;然而,作为钉仓狭槽的替代,此种钉仓可包括能够由切割构件切开的指定部分。在各种实施例中,可将各内侧缝钉排设置于钉仓内,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,可将各外侧缝钉排设置于钉仓内,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缝钉排存储在钉仓内。在至少一个实施例中,钉仓可包括六个缝钉排。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缝钉排,并且在切割构件狭槽的第二侧上包括三个缝钉排。在某些实施例中,钉仓可包括奇数个缝钉排。例如,钉仓可在切割构件狭槽的第一侧上包括两个缝钉排,并且在切割构件狭槽的第二侧上包括三个缝钉排。在各种实施例中,缝钉排可包括具有相同或至少基本上相同的未成形缝钉高度的缝钉。在某些其它实施例中,一个或多个缝钉排可包括与其它缝钉具有不同的未成形缝钉高度的缝钉。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缝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缝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161A-161D,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);紧固件仓(例如,钉仓5000),可移除地位于钉仓通道5030中;以及钳口5040,与钉仓5000及钉仓通道5030相对地定位。钉仓5000可包括可压缩本体5010及多个缝钉5020、和/或至少部分地位于可压缩本体5010中的任何其它适宜的紧固件。在至少一个此类实施例中,每一缝钉5020可包括基部5022和从基部5022向上延伸的腿部5021,其中腿部5021的至少一部分可被嵌入仓体5010中。在各种实施例中,可压缩本体5010可包括顶面或组织接触表面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例如可包括被限定在其中的多个支撑狭槽5032(图161D),所述多个支撑狭槽5032能够容纳并支撑缝钉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留矩阵(例如保留矩阵5050),所述保留矩阵能够接合缝钉5020并将组织捕获在保留矩阵与缝钉5020之间。在至少一个此类实施例中,保留矩阵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的保留矩阵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。更具体地讲,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,保留矩阵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161A,在各种实施例中,保留矩阵5050能够可拆卸地固定到钳口5040,使得当保留矩阵5050附接到钳口5040时,保留矩阵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留结构,所述一个或多个保留结构能够将保留矩阵5050保持就位。在至少一个此类实施例中,保留矩阵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留矩阵5050粘附至钳口5040。在任何情形中,钳口5040可运动至其中保留矩阵5050接触组织T且组织T抵靠钉仓5000的组织接触表面5019而定位的位置中。当组织T被钳口5040定位成抵靠钉仓5000时,所述钉仓5000的可压缩本体5010可被钳口5040压缩或可不被其压缩。在两种情形中的任一种情形中,在各种实施例中,缝钉5200的腿部5021可不穿过钉仓5000的组织接触表面5019而突起,如图161A所示。此外,同样如图161A所示,在保留矩阵5050不接合缝钉5020的情况下,钳口5040能够抵靠可压缩本体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,设想了其它实施例,其中缝钉末端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161B,一旦端部执行器被适宜地定位,则钳口5040可朝钉仓通道5030向下运动,使得可压缩本体5010被砧座5040压缩,并使得组织接触表面5019相对于缝钉5020被向下推动。当组织接触表面5019被向下推动时,缝钉腿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,保留矩阵5050可定位在缝钉5020上方,使得保留矩阵5050的保留孔5052与缝钉腿5021的末端5023对齐或至少基本上对齐。
现在参见图161C,当沿轴线5099向下推动保留矩阵5050时,缝钉5020的缝钉腿5021可进入保留孔5052中。在各种实施例中,缝钉腿5021可接合保留孔5052的侧壁。在某些实施例中,如以下所更详细描述,保留矩阵可包括延伸至保留孔5052中和/或围绕保留孔5052的一个或多个保留构件,所述一个或多个保留构件能够接合缝钉腿5021。在两种情形中的任一种情形中,缝钉腿5021可被保持在保留孔5052中。在各种情形中,缝钉腿5021的末端5023可进入保留孔5052中并可带有摩擦地接合保留构件和/或孔5052的侧壁。当保留矩阵5050朝缝钉5020的基部5022被推动时,缝钉腿5021可相对于侧壁和/或保留构件进行滑动。作为上文的结果,缝钉腿5021与保留矩阵5050之间可产生滑动摩擦力,其中这种滑动摩擦力可抵抗保留矩阵5050插入至缝钉5020上。在各种实施例中,当保留矩阵5050沿缝钉5020的缝钉腿5021向下滑动时,保留矩阵5050与缝钉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,由于例如缝钉腿5021、保留孔5052、和/或延伸至保留孔5052中和/或围绕保留孔5052的保留构件在几何形状上的变化;当保留矩阵5050沿缝钉腿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的可压缩本体5010也可抵抗保留矩阵5050插入缝钉5020中。更具体地讲,可压缩本体5010可例如由弹性材料构成,所述弹性材料可对保留矩阵5050施加抗力;当可压缩本体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,由于仓体5010而使抗力产生的增大可与仓体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,由于仓体5010而使抗力产生的增大可与仓体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和保留矩阵5050施加足够的击发力,以克服上述抗力及摩擦力。在使用中,保留矩阵5050可相对于缝钉5020被安放至任何适宜的深度处。在至少一个实施例中,保留矩阵5050可相对于缝钉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。在各种情形中,包括保留矩阵5050及缝钉5020的系统可容许外科医生通过选择保留矩阵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,保留矩阵5050可朝缝钉5020的缝钉基部5022被向下推动,直至保留矩阵5050被安放至与支撑狭槽5032的底部相距特定深度5011为止,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留矩阵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。在各种情形中,施加到组织T的压缩力或压力可取决于位于保留矩阵5050与钉仓5020之间的组织T的厚度。更具体地讲,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。
在各种情形中,对上文进行进一步描述,外科医生可调整保留矩阵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,外科医生可将保留矩阵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留矩阵5050与钉仓5010之间的组织T施加的压缩力的大小。在各种情形中,外科医生可将保留矩阵5050与缝钉5020接合,并将保留矩阵5050定位成与缝钉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,外科医生可将保留矩阵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,外科医生可将保留矩阵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,包括保留矩阵5050及缝钉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161D,在各种实施例中,缝钉腿5021可穿过保留矩阵5050而被插入,使得缝钉腿顶端5023延伸至保留矩阵5050的顶面上方。再次参见图161C,在至少一个实施例中,钳口5040还可包括被限定在其中的间隙孔5042,该间隙孔能够当缝钉腿末端5023穿过保留矩阵5050中的保留孔5052时容纳缝钉腿末端5023。在至少一个此类实施例中,间隙孔5042可与保留孔5052对齐,使得腿部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,使得不论保留矩阵5050被安放的距离为何,缝钉腿5021均不接触钳口5040。现在参见图161D,在保留矩阵5050与缝钉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而运动。更具体地讲,钉仓通道5030可从所植入的钉仓5000拆卸,并且砧座5040可从所植入的保留矩阵5050拆卸。当钳口5040远离保留矩阵5050而行进且缝钉支撑件5032远离缝钉基部5022而行进时,尽管钳口5040及钉仓通道5030不再对保留矩阵5050及基部5022提供支撑,然而仍可保持保留矩阵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对保留矩阵5050施加偏置力,然而缝钉腿5021与保留矩阵5050之间的静摩擦力可足以将保留矩阵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留矩阵5050和缝钉5020施加弹性偏置力,使得所述弹性偏置力趋于推动保留矩阵5050及缝钉5020以使其分开,然而这种运动受到缝钉腿5021与保留矩阵5050之间的摩擦接合的对抗。
在各种实施例中,如上所述,保留矩阵可包括多个保留孔,其中每一保留孔能够在其中容纳紧固件的腿部。在至少一个实施例中,现在参见图162,其中示出保留矩阵5150的一部分,该部分可包括由周边5156限定的保留孔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/或任何其它适宜的外形。在某些实施例中,保留矩阵5150可包括一个或多个保留构件(例如保留构件5153),所述一个或多个保留构件延伸至孔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,每一保留构件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,每一悬臂可包括第一端部和第二端部,所述第一端部附接到保留矩阵本体5158,所述第二端部形成保留孔5152的周边5156。在某些实施例中,保留孔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留构件5153中的一者或多者并使其挠曲,以便在紧固件支腿插入保留孔5152中时使保留孔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留孔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162,在各种实施例中,孔5152可由可变形构件5153限定,其中每一可变形构件5153能够相对于或独立于其它可变形构件5153而挠曲。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,该狭槽能够容许每一可变形构件5153相对于其它可变形构件5153屈曲。在某些实施例中,每一狭槽5154可包括位于保留矩阵本体5158中的第一端部5155、开口至保留孔5152中的第二端部、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。在各种其它实施例中,每一狭槽5154的宽度可不一致,并且每一狭槽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(例如圆形部),所述放大部既可为附接到保留矩阵本体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的挠性。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提供期望的挠性。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更具挠性。在至少一个实施例中,每一可变形构件5153的宽度可被选择成为其提供期望的挠性。更具体地讲,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挠性。再次参见图162,在某些实施例中,可变形构件5153的悬臂的附接到保留矩阵本体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162,在各种实施例中,保留矩阵本体5158可包括具有组织接触表面5151及顶面5157的平的或至少基本上平的材料薄片。在至少一个此类实施例中,组织接触表面5151与顶面5157可相互平行或至少基本上相互平行。在各种实施例中,每一可变形构件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,保留矩阵本体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可沿远离保留矩阵本体5158的顶面5157的方向延伸,并且在某些实施例中,第二部分5153b可朝保留孔5152的中心轴线5159会聚。在任何情形中,在各种实施例中,第二部分5153b能够当紧固件支腿穿过第二部分5153b而被插入时,第二部分5153b会远离中心轴线5159而挠曲。在其中缝钉5020的缝钉腿5021插入保留孔5152中的实施例中,可变形构件5153可沿大致远离缝钉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可沿与缝钉腿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例如可分别包括锋利的顶端,所述锋利的顶端能够当缝钉腿5021插入其中时,所述顶端抵靠缝钉腿5021进行滑动。第二部分5153b的锋利末端也能够如果缝钉腿5021沿相反方向(即,将从保留孔5052移除缝钉腿5021的方向)被牵拉,则所述锋利末端咬合至缝钉腿5021中。在某些情形中,第二部分5153b可相对于缝钉腿5021的边倾斜大于90度的角度,因此当缝钉腿5021受到趋于从保留孔5052中撤出缝钉腿5021的力时,第二部分5153b可挖入或掘入缝钉腿5021的边中。在某些实施例中,缝钉腿5021可在其表面中包括压痕和/或腔(例如微压痕),所述压痕和/或腔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,当对缝钉腿5021施加撤出力时,可变形构件5053的末端可被困于或掘入缝钉腿5021的压痕中。在各种实施例中,作为第二部分5153b掘入缝钉腿5021中的结果,为从保留孔5022中移除缝钉腿5021而作用的力可仅将第二部分5153b安放至缝钉腿5021中的更深处并增大移除缝钉腿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可更容许缝钉腿5021插入保留孔5152中且更抵抗缝钉腿5021的撤出。因此,在至少一个实施例中,将缝钉腿5021插入保留孔5022中期望的力可小于从保留孔5022中移除缝钉腿5021期望的力。在各种实施例中,例如从保留孔5022中移除缝钉腿5021期望的力可比将缝钉腿5021插入保留孔5022中期望的力约50%。在各种其它实施例中,例如移除缝钉腿5021期望的力可比插入缝钉腿5021期望的力约10%至约100%之间。在某些实施例中,例如移除缝钉腿5021期望的力可为插入缝钉腿5021期望的力的约100%、约150%、约200%、和/或比插入缝钉腿5021期望的力约200%。
再次参见图162,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。更具体地讲,第二部分5153b可限定凹坑5160,凹坑5160能够当紧固件支腿被插入保留孔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可限定锥形的或截头锥形的凹坑。在各种实施例中,凹坑可由适宜数目的可变形构件(例如四个可变形构件5153(图162)、六个可变形构件5153(图163)、或八个可变形构件5153(图164))限定。现在参见图165,在某些实施例中,保留矩阵(例如保留矩阵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,保留矩阵5250例如可包括多个保留孔(例如保留孔5252),所述多个保留孔可由周边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/或其它适宜的外形。在某些实施例中,保留矩阵5250可包括一个或多个保留构件(例如保留构件5253),所述一个或多个保留构件延伸至孔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,每一保留构件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,每一悬臂可包括第一端部和第二端部,所述第一端部附接到保留矩阵本体5258,所述第二端部形成保留孔5252的周边5256。在某些实施例中,保留孔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留构件5253中的一者或多者并使其挠曲,以便在紧固件支腿插入保留孔5252中时使保留孔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留孔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165,在各种实施例中,孔5252可由可变形构件5253限定,其中每一可变形构件5253能够相对于或独立于其它可变形构件5253而挠曲。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能够容许每一可变形构件5253相对于其它可变形构件5253屈曲。在各种实施例中,保留矩阵本体5258可包括具有组织接触表面5251及顶面5257的平的或至少基本上平的材料薄片。在至少一个此类实施例中,组织接触表面5251与顶面5257可相互平行或至少基本上相互平行。在各种实施例中,每一可变形构件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,保留矩阵本体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可沿远离保留矩阵本体5258的顶面5257的方向延伸,并且在某些实施例中,第二部分5253b可朝保留孔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165,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5253b与孔5252之间限定凹坑。更具体地讲,第二部分5253b可限定凹坑,所述凹坑能够当紧固件支腿被插入保留孔5252中时,所述凹坑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,凹坑可由适宜数目的可变形构件(例如可限定正方形的四个可变形构件5253(图165)、可限定六边形的六个可变形构件5253(图166)、或可限定八边形的八个可变形构件5253(图167))限定。
现在参见图168,在各种实施例中,保留矩阵(例如,保留矩阵5350)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留矩阵5350的本体5358中形成多个孔5352。材料薄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/或保留孔5352的周边5356。冲压模具也能够将可变形构件5353弯曲成适宜的构型。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169,在各种实施例中,保留矩阵(例如保留矩阵5450)可包括多个保留孔5452。与上文相似,每一保留孔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,每一可变形构件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,保留矩阵5450可包括围绕或至少基本上围绕保留孔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,每一孔5455可包括圆形或至少基本上圆形的周边和/或任何其它适宜的周边。在使用中,孔5455既可为附接到保留矩阵本体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的挠性。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更具挠性。此外,更靠近可变形构件5453的孔5455与更远的孔5455相比可提供更大的挠性。
现在参见图170,在各种实施例中,保留矩阵(例如,保留矩阵5550)可包括多个保留孔5552。每一保留孔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可限定两个相对的凸片5553,所述两个相对的凸片5553能够接合紧固件的腿部,并且在紧固件支腿穿过凸片5553而被插入时,所述两个相对的凸片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可限定越长的凸片5553,所述凸片5553可比具有较小周长或直径的末端5555所限定的凸片5553更具挠性。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,每一凸片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,每一凸片5553可不关于其轴线对称。在至少一个这种可供选择的实施例中,当紧固件支腿穿过保留孔5552而被插入时,凸片5553可绕其轴线扭曲。现在参见图171,在各种实施例中,保留矩阵(例如保留矩阵5650)可包括多个保留孔5652。每一保留孔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,每一末端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172,在各种实施例中,保留矩阵(例如,保留矩阵5750)可包括多个保留孔5752。每一保留孔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可沿相互垂直或横跨的方向延伸。在某些实施例中,狭槽5754和末端5755可例如限定四个凸片5753,所述四个凸片5753能够接合紧固件支腿,并且当紧固件支腿穿过保留孔5752而被插入时,所述四个凸片5753发生挠曲。在至少一个实施例中,每一凸片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173,在各种其它实施例中,保留矩阵(例如保留矩阵5850)可包括多个保留孔5852。每一保留孔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可沿相互垂直或横跨的方向延伸。在某些实施例中,狭槽5854及末端5855可限定凸片5853,凸片5853能够接合紧固件支腿,并且当紧固件支腿穿过保留孔5852而被插入时,凸片5853发生挠曲。在至少一个实施例中,每一凸片5853可包括拱形的外形。更具体地讲,与图170中所示的尖的末端不同,每一凸片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174,在各种实施例中,保留矩阵(例如,保留矩阵5950)可包括多个保留孔5952。每一保留孔5952可包括多个狭槽(例如狭槽5954),其中每一狭槽5954可沿轴线5959延伸和/或居中。在各种实施例中,轴线5959可彼此横跨,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延伸穿过保留孔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,每一狭槽5954可包括面向保留孔5952的中心的开口端以及位于狭槽5954的相对末端处的第二端部或封闭端5955。与上文相似,狭槽5954及末端5955可例如限定三个凸片5953,所述三个凸片5953能够接合紧固件支腿,并且当紧固件支腿穿过保留孔5952而被插入时,所述三个凸片5953发生挠曲。在各种实施例中,每一凸片5953可包括在狭槽5954的相邻末端5955之间延伸的拱形构型。现在参见图175,在各种实施例中,保留矩阵(例如保留矩阵6050)可包括多个保留孔6052。每一保留孔6052可包括凸片6053,凸片6053能够接合紧固件支腿,并且当紧固件支腿被插入保留孔6052中时,凸片6053发生挠曲。在至少一个此类实施例中,凸片6053可包括固定到保留矩阵本体6058的基部以及包括拱形或弯曲外形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缝钉腿,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175,在各种实施例中,保留矩阵本体6058可包括多个狭槽6054和孔6055,所述多个狭槽6054和孔6055能够限定凸片6053和保留孔6052的各个部分。在至少一个实施例中,凸片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176,在某些实施例中,保留矩阵(例如保留矩阵6150)可包括多个保留孔6152。每一保留孔6152可包括凸片6153,该凸片能够接合紧固件支腿,并且当紧固件支腿被插入保留孔6152中时,该凸片发生挠曲。在至少一个此类实施例中,凸片6153可包括固定到保留矩阵本体6158的基部以及包括拱形或弯曲外形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,保留矩阵本体6158可包括多个狭槽6154及孔6155,所述多个狭槽6154及孔6155能够限定凸片6153及保留孔6152的各个部分。在至少一个实施例中,凸片6153可包括逐渐变细的构型,所述逐渐变细的构型包括拱形的边。在至少一个此类实施例中,凸片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缝钉,所述多个缝钉包括穿过保留矩阵中的多个保留孔而被插入的缝钉腿。在某些实施例中,如以下所更详细地描述,缝钉可被保持在第一钳口中,并且保留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。在各种情形中,位于第一钳口中的缝钉可被固定于其中,使得当保留矩阵与缝钉腿接合时,缝钉腿与保留孔对齐。参见图177和图178,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留矩阵6250。现在参见图184和图185,对上文进行进一步描述,保留矩阵6250可包括多个保留孔6252,其中每一保留孔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,用于限定每一孔6252的可挠曲构件6253可限定凹坑6201。在各种实施例中,每一凹坑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缝钉腿与保留孔6252未对齐并首先接触可挠曲构件6253和/或组织接触表面6251的情形中将缝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缝钉6220,所述多个缝钉6220包括可穿过保留矩阵6250中的保留孔6252而被插入的缝钉腿6221。在至少一个此类实施例中,每一缝钉6220可包括例如基本上为U形的构型,所述构型包括基部6222,所述缝钉腿6221可从基部6222向上延伸。现在参见图180和图181,在各种实施例中,保留矩阵6250中的保留孔6252可被布置成例如两个平行的或至少基本上平行的纵行,所述纵行可沿保留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,第一行中的保留孔6252可相对于第二行中的保留孔6252偏移或错列。在至少一个此类实施例中,每一缝钉6220可包括位于第一行的保留孔6252中的第一缝钉腿6221以及位于第二行的保留孔6252中的第二缝钉腿6221,其中作为结果,基部6222可沿横跨保留矩阵6250的纵向轴线的方向延伸。在至少一个此类实施例中,缝钉6220可相互平行或至少基本上相互平行。更具体地讲,例如缝钉6220a的基部6222a可平行于或至少基本上平行于缝钉6220b的基部6222b,所述缝钉6220b的基部6222b可平行于或至少基本上平行于缝钉6220c的基部6222c。在至少一个实施例中,例如缝钉6220a的缝钉腿6221a所限定的平面可平行于或至少基本上平行于缝钉6220b的缝钉腿6221b所限定的平面,并且缝钉6220b的缝钉腿6221b所限定的平面可平行于或至少基本上平行于缝钉6220c的缝钉腿6221所限定的平面。
现在参见图177和179,在各种实施例中,钉仓6200可包括多个缝钉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缝钉6220。在各种情形中,对齐矩阵6260能够使得在保留矩阵6250接合缝钉腿6221之前,缝钉6220的缝钉腿6221与保留矩阵6250中的保留孔6252对齐。现在参见图182和图183,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6262能够紧密地容纳缝钉6220的缝钉腿6221。在至少一个此类实施例中,每一缝钉6220可包括基部6222和从基部6222延伸的两个缝钉腿6221,其中缝钉6220的基部6222可围绕保留矩阵6260的底部表面6264延伸,并且缝钉腿6221可穿过对齐孔6262而向上延伸。在某些实施例中,每一对齐孔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缝钉腿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6263可从对齐矩阵6260的顶面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,其中在各种情形中,较长的孔6262可比较短的孔6262更好地控制缝钉腿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,并且支撑保留矩阵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,则第二钳口及保留矩阵6250可朝钉仓6200运动。在各种实施例中,当缝钉腿6221穿过保留矩阵6250的保留孔6252而被插入时,保留矩阵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面6261上。在各种其它实施例中,如以下将更详细地描述,钉仓6200还可例如包括位于对齐矩阵6260的顶面6261上方并可接触组织的可压缩仓体。再次参见图179和图183,在某些实施例中,对齐矩阵6260还可包括被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6203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,保留矩阵6250可包括多个孔6202,所述多个孔6202能够当保留矩阵6250抵靠组织而定位时,所述多个孔6202在其中容纳组织的至少一部分。
对上文进行进一步描述,当缝钉6220的缝钉腿6221穿过保留矩阵6250的保留孔6252而被插入时,缝钉腿6221的顶端可从保留矩阵6250的顶面6257向上突起。在各种情形中,如上所述,缝钉腿6221的末端可在穿过保留孔6252而被插入之后保持未弯曲。现在参见图186-189,在某些实施例中,包括钉仓6200及保留矩阵6250的紧固系统可包括多个保护性帽或覆盖件(例如帽6270),所述多个保护性帽或覆盖件可安装至突起于保留矩阵6250上方的缝钉腿6221。在各种实施例中,每一帽6270可完全或至少部分地覆盖缝钉腿6221的锋利末端,使得所述锋利末端不会接触与其相邻的组织。现在参见图189,在至少一个实施例中,每一帽6270可包括被限定在其中的孔6271,该孔能够在其中紧密地容纳缝钉腿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缝钉腿6221的周长或直径。在至少一个此类实施例中,保护性帽6270中的孔6271可扩展以在其中容纳缝钉腿6221。在各种可供选择的实施例中,帽6270可不包括孔,并且缝钉腿6221的末端能够当腿部6221插入帽6270时,所述末端切开帽6270。在任何情形中,在各种实施例中,每一帽6270均可被安放至缝钉腿6221上,直至帽6270的基部6272邻接或邻近保留矩阵6250的顶面6257而定位为止。在各种情形中,帽6270能够使得其被紧密地安放至缝钉腿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,每一帽6270可例如包括锥形的或至少基本上为锥形的外表面。在各种实施例中,帽6270可包括任何适宜的形状,例如包括抛物线形或至少基本上为抛物线形的外表面的形状。
在各种实施例中,例如可使用图190-192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能够支撑保留矩阵6250及所述多个保护性帽6270。主要参见图190,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位于保留矩阵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缝钉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以及一个或多个保留结构或保持器,所述多个凹陷部或孔6245能够容纳多个保护性帽6270,并且所述一个或多个保留结构或保持器能够相对于帽6270将保留矩阵6250保持就位。在至少一个此类实施例中,保留矩阵6250能够将帽6270保持在孔6245中。现在参见图202,在各种实施例中,每一孔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固定于孔6245中。在某些实施例中,可利用至少一种粘合剂来将帽6270固定于孔6245中。在至少一个此类实施例中,这种粘合剂可被选择成使得在帽6270接合缝钉腿6221且第二钳口6240远离已植入的紧固件组件运动之后,帽6270可从第二钳口6240拆卸。现在参见图203,在某些实施例中,第二钳口6240还可包括至少一个覆盖薄片6246,所述至少一个覆盖薄片6246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薄片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,覆盖薄片6246可至少部分地从钳口6240拆卸。在某些实施例中,覆盖薄片6246可由可植入材料(例如PDS和/或PGA)构成,当缝钉腿6221从保留矩阵6250暴露时,所述可植入材料可被缝钉腿6221切开。在至少一个此类实施例中,覆盖薄片6246可在覆盖件6270与保留矩阵6250之间被固定于紧固系统中。
现在参见图191,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抵靠保留矩阵6250及仓体6210而定位。在这种位置中,保留矩阵6250可不接合缝钉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可包括自其延伸的远侧销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191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。更具体地讲,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192,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、并使保留矩阵6250及多个保护性帽6270与缝钉6220的缝钉腿接合。在至少一个此类实施例中,致动器6235的额外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,使得保留矩阵6250保持平行于或至少基本上平行于仓体6210的顶面和/或平行于或至少基本上平行于对齐矩阵6260。在任何情形中,一旦保留矩阵6250及保护性帽6270接合缝钉6220的缝钉腿6221,如图194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可从已植入的钉仓6200拆卸,并且第一钳口6230和第二钳口6240可远离已植入的紧固件组件而被移除,如图193所示。
再次参见图192,读者应注意,尽管保留矩阵6250和帽6270已接合缝钉腿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。当厚的组织T位于保留矩阵6250与仓体6210之间时会发生这种情形。现在参见图195,在其中薄的组织T位于保留矩阵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197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195-197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,保留矩阵6250及保护性帽6270可进一步被驱动至缝钉6220的缝钉腿6221上,如图198和图199所示。在各种实施例中,作为保留矩阵6250所提供的可调整性的结果,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,保留矩阵6250所提供的可调整性可容许外科医生通过选择保留矩阵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,保留矩阵6250可被安放至缝钉腿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,保护性帽6270可由例如能够抓紧缝钉腿6221的末端的柔软的或挠性的材料构成。在某些实施例中,保护性帽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189所示,在至少一个实施例中,每一帽6270可不连接至其它帽6270。在某些其它实施例中,一个或多个帽6270可被安装至保留矩阵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留矩阵6250,其中帽6270中的孔6271可与保留矩阵6270中的保留孔6252对齐或至少基本上对齐。现在参见图200,在各种实施例中,保护性帽(例如帽6370)可限定内腔或穹窿6374,内腔或穹窿6374可例如能够将缝钉腿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,所述一个或多个可挠曲的构件6373能够当缝钉腿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201,在至少一个此类实施例中,多个帽6370可通过材料薄片6375而连接在一起。在某些实施例中,薄片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,并且薄片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,薄片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,例如在薄片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,例如可利用注模方法将薄片6375注模于帽6370周围,使得帽6370被嵌入薄片6375中。在某些其它实施例中,例如可利用注模方法来模制薄片6375,其中例如在注模方法期间和/或注模方法之后,可利用冲压方法在薄片6375中形成孔6376。在两种情形中的任一种情形中,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于孔6376中。在某些实施例中,每一帽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,薄片6375可由能够容许帽6370之间进行相对运动的挠性和/或柔韧材料构成。在至少一个此类实施例中,挠性薄片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,可将挠性材料模制于帽6370周围。在某些实施例中,例如可将帽6370按压至预先模制的薄片6375中。在各种实施例中,可将挠性材料的硬度选择成提供薄片6375期望的刚度。在某些实施例中,薄片6375能够使其包括挠性的带。在任何情形中,薄片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的薄片6375一旦被植入,则可例如沿缝钉线来强化或支持缝钉。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,这种链节可为挠性的并可容许帽6370之间进行相对运动。
现在参见图204和205,在各种实施例中,保护性帽(例如,帽6470)可包括成形表面,所述成形表面能够使缝钉腿的顶端变形。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能够将缝钉腿(例如缝钉腿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缝钉腿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,该腔或穹窿能够当缝钉腿6221被插入帽6470中时容纳缝钉腿6221的末端。主要参见图205,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缝钉腿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,并能够当缝钉腿6221被插入帽6470时使缝钉腿6221卷曲。在某些实施例中,缝钉腿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可被锁定至缝钉腿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缝钉腿6221从腔6474中被移除。在各种情形中,作为上文的结果,一个或多个帽6470可防止或抑制保留矩阵(例如保留矩阵6250)从缝钉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204,在各种可供选择的实施例中,孔6471可相对于中心轴线6479偏移。在至少一个此类实施例中,偏移的孔6471可容许缝钉腿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,保留矩阵(例如,保留矩阵6250)可由材料薄片及穿过所述材料薄片而延伸的多个保留孔6252构成。在至少某些实施例中,构成保留矩阵6250的材料薄片可为刚性的或基本上不可挠曲的。在某些其它实施例中,保留矩阵可由保留矩阵元件的阵列以及用于连接所述保留矩阵元件的多个挠性连接件或链节构成。现在参见图206,在各种实施例中,保留矩阵或保留矩阵6550的一部分可包括多个元件本体6505,所述多个元件本体6505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,每一元件本体6505均可包括多个可变形构件6553,所述多个可变形构件6553可在其中限定保留孔6552。在某些实施例中,保留矩阵6550的元件本体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,保留矩阵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,保留矩阵6550可由塑料(例如,聚醚醚铜(PEEK)、以商品名缝线(Prolene)出售的聚丙烯、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&Nurolon出售的长链脂肪族聚合物尼龙6及尼龙6,6)构成,并可例如通过注模方法形成。在某些实施例中,元件本体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本体6505,所述多个单一的元件本体6505随后被连接在一起并被嵌入保留矩阵中。在至少一个此类实施例中,元件本体6505可由金属材料(例如钛和/或不锈钢)冲压而成并被放置于塑料注射模具中,其中可将塑料材料注入模具中以形成围绕或至少部分地围绕元件本体6505的边缘6506和从边缘6506延伸的连接链节6507。在某些其它实施例中,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,其中每一这种孔均能够将元件本体6505容纳在其中。在至少一个实施例中,每一元件本体6505可包括圆形的或至少基本上为圆形的外周边;相似地,每一边缘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本体6505的直径。在至少一个此类实施例中,元件本体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本体6505固定于孔中。
在某些实施例中,对上文进行进一步描述,保留矩阵可包括多个元件本体6505以及多个连接链节6507,所述多个连接链节6507可以任何适宜的阵列(例如,图207-210所示者)来连接元件本体6505。不论阵列的图案为何,在各种实施例中,连接链节6507能够容许元件本体6505与保留孔6552相对于彼此进行运动。在至少一个此类实施例中,构成保留矩阵6550的元件本体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/或换句话讲屈曲,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,每一连接链节6507可包括挠性构件,所述挠性构件能够拉伸、扭曲、和/或塌缩,以便例如容许保留矩阵6550在保留矩阵元件6505之间屈曲。再次参见图206,限定自边缘6506延伸的每一链节6507的宽度可窄于元件本体6505和/或边缘6506的宽度。参见图207-210,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本体6506之间的线延伸。在至少一个此类实施例中,每一链节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206,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,保留矩阵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可沿第一线延伸,并且第二链节6507可沿第二线延伸,其中所述第一线与所述第二线可成角度(例如约30度、约45度、约60度、和/或约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屈曲和/或过多次数地屈曲时断裂。在至少一个此类实施例中,这种易碎部可容许保留矩阵6550的一个或多个部分与保留矩阵6550的另一部分断开。在各种实施例中,铰链6508和/或铰链6509例如可包括保留矩阵6550的比保留矩阵6550的其它部分更容易切割的段。更具体地,已植入的保留矩阵及由已植入的保留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这种横切,铰链6508和/或铰链6509例如可提供途径或薄的段,切割构件可穿过所述途径或薄的段更容易地穿过保留矩阵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,保留矩阵可包括多个保留矩阵元件(例如,矩阵元件本体6505),所述多个保留矩阵元件可嵌入挠性材料薄片或材料带中。在至少一个实施例中,挠性材料薄片可由可生物吸收的弹性体材料(例如硅氧烷)形成,其中所述挠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,可模制出实心的挠性薄片并在所述挠性薄片中穿孔形成多个孔。在各种可供选择的实施例中,可模制挠性薄片并在模制过程中形成限定在其中的孔。在两种情形中的任一种情形中,保留矩阵元件6505例如可被插入并保持在挠性薄片中。在某些其它实施例中,与上文相似,挠性薄片可形成于矩阵元件6505周围。在至少一个实施例中,挠性薄片可例如由机织网和/或任何其它适宜的材料构成。对上文进行进一步描述,这种机织网可易于横切。
现在参见图211和212,在各种实施例中,包括保留矩阵(例如,保留矩阵6250)的紧固件系统还可包括覆盖件(例如,覆盖件6670),当缝钉腿6221的顶端延伸至保留矩阵6250的顶面6257上方时,所述覆盖件可覆盖所述顶端。在各种实施例中,覆盖件6670可附接到保留矩阵6250。在某些实施例中,覆盖件6670和/或保留矩阵6250可包括保留结构,所述保留结构能够将覆盖件6670保持到保留矩阵6250。在至少一个实施例中,可利用至少一种粘合剂将覆盖件6670粘附到保留矩阵6250。在至少一个实施例中,覆盖件6670可由单个层构成,然而覆盖件6670被示出为包括两个层,如以下所更详细地描述。主要参见图212,在各种实施例中,缝钉腿6221的顶端可延伸穿过覆盖件6670的底部表面6673;然而,覆盖件6670可包括足够的厚度,以使缝钉顶端不会延伸穿过覆盖件6670的顶面6675。因此,在至少一个此类实施例中,缝钉腿6221的末端可不从覆盖件6670突起。在各种实施例中,覆盖件6670可包括多个层。在至少一个此类实施例中,覆盖件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可由能够被缝钉腿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/或任何适宜的支撑材料构成。在至少一个此种实施例中,缝钉腿6221能够穿透第一层6671;然而,在各种实施例中,缝钉腿6221可无法穿透第二层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被缝钉腿6221接触并移位,但不被缝钉腿6221的缝钉末端切割或仅被少量地切割。尽管图中未示出,然而覆盖件可包括不止两个层,其中这些层中的一者或多者可为耐渗透的。在至少一个此类实施例中,在使用中,保留矩阵6250可抵靠组织而定位并被紧固且朝远侧推动,使得缝钉6220的缝钉腿6221穿过组织T及保留矩阵6250中的保留孔6252而被推动,并进入覆盖件6270的第一层6271中。在各种实施例中,缝钉腿6221的末端可不进入或至少基本上不进入覆盖件6270的第二层6272中。在保留矩阵6250被适当地定位之后,钳口6240可被打开,并且覆盖件6670及保留矩阵6250可从钳口6240拆卸,如图211所示。如图211所示,钳口6640能够保持不止一个保留矩阵6250及覆盖件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覆盖件6670以及相对于覆盖件6670而定位的保留矩阵6250,使得每一保留矩阵6250的组织接触表面6251从钳口6240的底部向下靠。在至少一个此类实施例中,保留矩阵6250及覆盖件6270可在刀狭槽6678的每一侧上容纳在钳口6640中。在使用中,保留矩阵6250及覆盖件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,覆盖件6670可不附接到保留矩阵6250。在至少一个此类实施例中,覆盖件6670可被定位在通道6679中并可通过能够被固定到钳口6640的保留矩阵6250而被保持在通道6679中。在各种实施例中,每一保留矩阵6250可宽于和/或长于其相应的覆盖件6670,使得保留矩阵6250可将其覆盖件6670的整体保持就位。在某些实施例中,每一保留矩阵6250可例如与其相应的覆盖件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留矩阵(例如,保留矩阵6250)的材料层。现在参见图215,在至少一个实施例中,材料层6870可附接到保留矩阵6250的底部表面6251。在某些实施例中,层6870和/或保留矩阵6250可包括保留结构,所述保留结构能够将层6870保持到保留矩阵6250。在至少一个实施例中,可利用至少一种粘合剂将层6870粘附到保留矩阵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能够当保留矩阵6250朝缝钉6220向下运动以使保留孔6252与缝钉腿6221相接合时,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留矩阵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(例如电离的银和/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被压缩且缝钉腿6221穿透组织T及层6870时,药物例如可沿缝钉腿6221流下并治疗已被缝钉腿6221切开的组织。在各种实施例中,保留矩阵6250的本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/或例如电离的银和/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215中仅示出一个层6870,然而可使用任何适宜数目的层。在至少一个实施例中,包括第一药物的第一层可附接到保留矩阵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,其中每一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213,在各种实施例中,紧固件系统可包括附接到保留矩阵6250的底部表面6251的材料层6770。在某些实施例中,层6770和/或保留矩阵6250可包括保留结构,所述保留结构能够将层6770保持到保留矩阵6250。在至少一个实施例中,可利用至少一种粘合剂将层6770粘附到保留矩阵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能够当保留矩阵6250朝缝钉6220向下运动以使保留孔6252与缝钉腿6221相接合时,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留矩阵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214,在某些实施例中,囊6774可与保留孔6252对齐或至少基本上对齐,使得当缝钉腿6221穿过组织T及层6770而被推动时,缝钉腿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,所述流体可沿缝钉腿6221留下或依靠毛细作用流下并治疗被缝钉腿切开的组织T。作为上文的结果,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可由挠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的段或弱化部分(例如局部穿孔),所述一个或多个薄的段或弱化部分可有利于腿部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留矩阵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。在某些其它实施例中,囊6774中的一者或多者可经由延伸穿过层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No.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、缝钉、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,保留矩阵和/或一个或多个覆盖件可被加载至端部执行器的第二钳口中。现在参见图216,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可包括第一保留部和第二保留部,所述第一保留部能够将钉仓6200的仓体6210保持到仓载体6992,并且所述第二保留部能够保持仓体6980,该仓体6980在其中支撑多个保护性帽6270并沿仓体6980的底部表面支撑保留矩阵6250。在各种实施例中,第一保留部和第二保留部可分别包括一个或多个保留构件,所述一个或多个保留构件能够可释放地接合仓体6210和6980。现在参见图217和图218,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。在各种情形中,顶部钳口6940可通过致动器6235而从打开位置(图217)旋转到闭合位置(图218),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218,一旦顶部钳口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的外科医生或其它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中的一个或多个保留部,如以下所更详细地描述。现在参见图219,在任何情形中,一旦钉仓6200及仓体6980被安放,则仓加载器6990可从钉仓6200及仓体6980上拆卸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中的保留力可大于用于将钉仓6200保持到仓载体6992的保留力,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中的保留力可大于用于将仓体6940保持到仓载体6992的保留力,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220,第二钳口6940可从打开位置(图219)运动到击发位置(图220),以便使仓体6980所携载的保留矩阵6250及所述多个保护性帽6270与位于钉仓6200中的缝钉6220相接合。
现在参见图221及图222,第二钳口6940可被再次打开,并且所述多个保护性帽6270及保留矩阵6250可从仓体6980上拆卸,使得帽6270及保留矩阵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留狭槽,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留狭槽能够将保留矩阵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相接合的保留构件可将仓体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及保留矩阵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221和图222,在第二钳口6940打开之后,第一钳口6230的与仓体6210相接合的保留构件可将仓体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的一部分与缝钉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223-225,在各种实施例中,钉仓(例如钉仓6900)可包括沿仓体6910的长度延伸的一个或多个纵向保留狭槽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留狭槽6913能够在其中容纳从钳口6930延伸的一个或多个纵向保留导轨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,保留狭槽6913的末端可与保留导轨6916的远端对齐。
再次参见图225,在各种实施例中,钳口6940可包括两个保持通道6949,其中每一保持通道6949能够在其中容纳包括多个帽6270及保留矩阵6250的仓体6980。在某些实施例中,每一仓体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6917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留导轨6918滑动。在各种实施例中,当仓体6980从存储在其中的帽6270及保留矩阵6250上拆卸时,保留导轨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224,在各种实施例中,第二钳口6940还可包括自其延伸的一个或多个远侧凸块或保留构件6915,所述一个或多个远侧凸块或保留构件6915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相对于每一保持通道6949能够及定位成使得当仓体6980被插入通道6949中时,每一仓体6980可围绕凸块6915屈曲,其中,就在仓体6915被完全安放于通道6949中时,仓体6980的远端可清洁凸块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可包括自其延伸的一个或多个远侧保留凸块6914,所述一个或多个远侧保留凸块6914能够当钉仓6900被完全安放时,所述一个或多个远侧保留凸块6914被容纳在仓体6910中的一个或多个保留沟槽或狭槽6912(图223)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于其间。在某些实施例中,当第一紧固件与第二紧固件接合时,第一紧固件仓与第二紧固件仓可相互接合。在至少一个实施例中,第一紧固件仓的本体可由第一可压缩材料构成,并且第二紧固件仓的本体可由第二可压缩材料构成,其中第一本体和/或第二本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第一紧固件仓或类似元件,并且第二钳口可再次加载另一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缝钉,然而也可设想出包括其它类型的紧固件(例如当相互接合时锁定在一起的分为两部分的紧固件)的其它实施例。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适宜类型的材料和/或形式的紧固件。在某些实施例中,紧固件可包括穿透构件。这种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,可利用任何适宜的方法(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,缝钉腿的穿过保留矩阵突起的顶端可由一个或多个帽和/或覆盖件覆盖。在某些实施例中,缝钉腿的末端在插穿保留矩阵之后可变形。在至少一个实施例中,用于保持保留矩阵的钳口还可包括位于保留孔上方和/或与保留孔对齐的砧座凹坑,所述砧座凹坑能够在缝钉腿突起于保留矩阵上方时使缝钉腿变形。在各种实施例中,每一缝钉的缝钉腿可例如朝彼此和/或朝缝钉的中心向内卷曲。在某些其它实施例中,缝钉的缝钉腿中的一者或多者可远离其它缝钉腿和/或远离缝钉的中心而向外卷曲。在各种实施例中,不论缝钉腿沿哪一方向卷曲,缝钉腿的末端均可接触保留矩阵的本体并可不再次进入已被缝钉紧固的组织中。在至少一个实施例中,缝钉腿在穿过保留矩阵之后的变形可将保留矩阵锁定在定位中。
现在参见图226及图227,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的运动而朝向并远离第一钳口7030行进。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226中未绘示出这种钉仓的仓体,然而这种钉仓可包括仓体、位于仓体内的缝钉6220、以及位于缝钉6220下方的缝钉驱动器7012。在某些实施例中,尽管为简明起见未在图226中示出,然而第二钳口7040能够将保留矩阵(例如保留矩阵6250)保持在缝钉6220之上和/或如上所述移将保留矩阵运动至与缝钉6220的腿部接合。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中的橇7010,橇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的保留矩阵提升缝钉驱动器7012及支撑在缝钉驱动器7012上的缝钉6220。在各种其它实施例中,例如橇7010可从近端7032朝远端7031运动,以便部署缝钉6020。在至少一个实施例中,橇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7011能够在缝钉驱动器7012下方滑动并向上提升缝钉驱动器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橇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226,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),如以下所更详细地描述,所述一个或多个导轨能够引导能够在缝钉6220的缝钉腿6221穿过保留矩阵之后接合缝钉6220的缝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可包括沿引导线材或缆线,所述引导线材或缆线例如沿框架7041的顶部或顶面、围绕远侧柱7047、并返回沿框架7041的顶部或顶面而延伸。如上所述,并且现在主要参见图228和图230,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,以便在缝钉6220的腿部穿过保留矩阵之后使所述腿部变形。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226,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228,在至少一个实施例中,导轨7046可被固定于导槽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可以与第二砧座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挠性,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挠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228及图230,在各种实施例中,第一砧座7050可包括自其延伸的凸轮从动件7055,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231))中。更具体地讲,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,每一凸轮狭槽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可包括自其延伸的凸轮从动件7065,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231)中。更具体地讲,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,每一凸轮狭槽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,如以下所更详细地描述。
当外科缝合器7000处于未击发状态时,参见图231,第一砧座7050可被定位在框架7041的远端7048处,并且第二砧座7060可被定位在框架7041的近端7049处;此外,现在参见图232,当外科缝合器7000处于未击发状态时,位于第一钳口7030中的缝钉6220可尚未被插入组织T和/或位于组织T上方的保留矩阵中。现在参见图233,在使用中,缝钉驱动器7012可在钉仓的缝钉腔7033内向上驱动缝钉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,以便接合缝钉6220的缝钉腿6221。在至少一个实施例中,在第一砧座7050与缝钉6220的缝钉腿6221接合之前可向上驱动缝钉6220。在各种实施例中,在第一砧座7050推进至接触缝钉腿6221之前,橇7010可向上部署所有的缝钉6220,或作为另外一种选择,橇7010可在第一砧座7050朝近侧运动的同时朝近侧运动,然而橇7010可充分地引导第一砧座7050以将缝钉6220部署于第一砧座7050前方。在各种实施例中,如图233所示,凸轮狭槽7070能够或被设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)可接触缝钉腿6221中的至少一些缝钉腿6221。在各种情形中,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由此穿过停歇部中时,缝钉腿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234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朝缝钉腿6021向下垂直运动,以便将缝钉腿6021驱动至其完全成形的构型中。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233和图234所示,读者应注意,第一砧座7050可仅接合某些缝钉腿而不接合其它缝钉腿。在至少一个此类实施例中,第一砧座7050能够例如仅使包括缝钉6220的远侧缝钉腿6221的一组缝钉腿变形。在至少一个此类实施例中,第一砧座7050能够使远侧缝钉腿6221朝缝钉6220的中心变形。在各种实施例中,每一近侧缝钉腿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可使远侧缝钉腿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可使远侧缝钉腿6221变形至完全成形构型。现在参见图228和图229,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,以便在缝钉腿6221被布置成不止一行或一条线时使缝钉6220的远侧缝钉腿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可使缝钉6020的近侧缝钉腿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,以便使缝钉6220的所有远侧缝钉腿6221变形。读者应注意,第一砧座7050可相对于未变形的近侧缝钉腿6221向上及向下运动,并且为适应这种相对运动,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230),所述一个或多个间隙狭槽7057能够当第一砧座7050使远侧缝钉腿6221弯曲时容纳未弯曲的近侧缝钉腿6221。相似地,再次参见图228,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。在所有远侧缝钉腿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235,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,以便使近侧缝钉腿6221朝缝钉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可分别能够使近侧缝钉腿6021中的一者或多者至少部分地变形和/或完全变形。再次参见图229,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能够使排列成多个行或多条线的缝钉6220的近侧缝钉腿6221变形。同样如图229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,其中作为结果,缝钉6220的近侧腿部6221可与缝钉6220的远侧腿部6221位于不同的行或线中。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。在缝钉6220的所有近侧缝钉腿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中定位新的保留矩阵,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沿纵向行进以便沿横切方向接合多个缝钉的腿部。在某些实施例中,外科缝合器可包括朝近侧运动的砧座,例如以使第一组缝钉腿变形并例如使第二组缝钉腿变形。在至少一个此类实施例中,这种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236,在各种实施例中,砧座(例如,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,每一凹坑板7143均可定位在框架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,每一凹坑板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,每一凹坑板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,每一板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的相配合的外形(例如图236中所示的锯齿形外形)。在至少一个实施例中,每一板7143可包括例如约.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237,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236和图237所示,每一凹坑板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,可通过任何适宜的制造方法(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238和图239,在至少一个此类实施例中,例如可通过以下方法来制造每一成形凹坑7142:首先形成深井7150,随后围绕深井7150形成拱形的或弯曲的表面7151,然后在弯曲的表面7151中形成缝钉腿引导沟槽7152。在各种其它实施例中,可以任何适宜的顺序来执行这些步骤。现在参见图240,在各种实施例中,缝钉成形凹坑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240,在各种实施例中,每一成形凹坑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。在各种其它实施例中,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。在各种情形中,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,还可使用至少一种钎焊方法将板7143固定于框架7144中。
现在参见图241-243,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,每一凹坑板7243可包括被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可包括被限定在其中的保留狭槽7246,该保留狭槽能够容纳从凹坑板7243延伸的保留导轨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可向外屈曲或展开(如图242所示),以使保留狭槽7246变宽,从而使每一保留狭槽7246可在其中容纳凹坑板7243的保留导轨7247。一旦保留导轨7247被定位在保留狭槽7246中,侧壁7245即可被释放(如图243所示),从而容许框架7244以弹性方式缩回和/或返回至其未屈曲状态。在这种情形中,保留狭槽7246可缩回并因此将保留导轨7247捕获在其中。在某些实施例中,保留导轨7247和/或保留狭槽7246可包括一个或多个相配合的锥形表面;在屈曲的保留狭槽7246被释放之后,所述一个或多个相配合的锥形表面可形成能够将保留导轨7247保持在保留狭槽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。在各种情形中,根据所使用的材料,例如可使用至少一种钎焊方法和/或至少一种焊接方法将板7243固定于框架7244中。
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。重新恢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。特别是,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。该密封容器保持装置无菌直到在医疗设施中打开该容器。
以引用方式全文或部分地并入本文的任何专利、公布或其它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、陈述或其它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材料。如果据述以引用方式并入本文但与本文所述的现有定义、陈述或其它公开材料相冲突的任何材料或其部分,仅在所并入的材料和现有的公开材料之间不产生冲突的程度下并入本文。
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、用途或改型。此外,本专利申请旨在涵盖本发明所属领域中属于已知或惯有实践范围内的与本公开不同的型式。
Claims (2)
1.一种钉仓,包括:
多个缝钉,其中每一所述缝钉包括基部以及从所述基部延伸的可变形构件,其中每一所述可变形构件包括末端;
可植入的钉仓本体,所述可植入的钉仓本体包括:
由第一材料构成的第一可压缩层,其中所述基部被嵌入所述第一可压缩层中;
由第二材料构成的第二可压缩层,其中所述末端被嵌入所述第二可压缩层中,其中所述第一可压缩层包含第一刚度,其中所述第二可压缩层包含第二刚度,并且其中所述第一刚度不同于所述第二刚度;以及
围绕所述第一可压缩层和所述第二可压缩层的包裹物,其中当所述可植入的钉仓本体被砧座压缩时,所述末端能够切割所述包裹物。
2.一种紧固件仓,包括:
多个紧固件,其中每一所述紧固件包括基部以及从所述基部延伸的可变形构件,其中每一所述可变形构件包括末端;以及
可植入的仓体,所述可植入的仓体包括:
由第一材料构成的第一可压缩层合物,其中所述基部被嵌入所述第一可压缩层合物中;
由第二材料构成的第二可压缩层合物,其中所述末端被嵌入所述第二可压缩层合物中,其中所述第一可压缩层合物包含第一刚度,其中所述第二可压缩层合物包含第二刚度,并且其中所述第一刚度不同于所述第二刚度;以及
围绕所述第一可压缩层合物和所述第二可压缩层合物的包裹物,其中当所述可植入的仓体被砧座压缩时,所述末端能够切割所述包裹物。
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CN201180046490.3A Active CN103153206B (zh) | 2010-09-30 | 2011-09-23 | 支撑非线性排列缝钉的外科钉仓以及具有共用缝钉成形凹坑的外科缝合器械 |
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CN201180046498.XA Expired - Fee Related CN103118606B (zh) | 2010-09-30 | 2011-09-23 | 具有可重构轴段的外科器械 |
CN2011800476188A Pending CN103124529A (zh) | 2010-09-30 | 2011-09-27 | 具有可变缝钉成形系统的外科缝合器械 |
CN201180047613.5A Active CN103140182B (zh) | 2010-09-30 | 2011-09-27 | 包括多个层的可植入紧固件仓 |
CN201180047217.2A Active CN103153207B (zh) | 2010-09-30 | 2011-09-27 | 可选择性取向的可植入紧固件仓 |
CN201180047047.8A Active CN103124527B (zh) | 2010-09-30 | 2011-09-28 | 包括可生物吸收层的可植入的紧固件仓 |
CN201180047614.XA Active CN103124528B (zh) | 2010-09-30 | 2011-09-28 | 具有可拆卸的支撑结构的外科钉仓 |
CN201180047225.7A Active CN103153202B (zh) | 2010-09-30 | 2011-09-29 | 包括保持矩阵的紧固件系统 |
CN201180047369.2A Active CN103140181B (zh) | 2010-09-30 | 2011-09-29 | 可塌缩的紧固件仓 |
CN201180046991.1A Active CN103140177B (zh) | 2010-09-30 | 2011-09-29 | 包括多个连接的保持矩阵元件的紧固件系统 |
CN2011800472242A Pending CN103153208A (zh) | 2010-09-30 | 2011-09-29 | 包括多个紧固件仓的紧固件系统 |
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CN201180046490.3A Active CN103153206B (zh) | 2010-09-30 | 2011-09-23 | 支撑非线性排列缝钉的外科钉仓以及具有共用缝钉成形凹坑的外科缝合器械 |
CN201180047616.9A Active CN103140179B (zh) | 2010-09-30 | 2011-09-23 | 用于外科器械的钳口闭合装置 |
CN201180046498.XA Expired - Fee Related CN103118606B (zh) | 2010-09-30 | 2011-09-23 | 具有可重构轴段的外科器械 |
CN2011800476188A Pending CN103124529A (zh) | 2010-09-30 | 2011-09-27 | 具有可变缝钉成形系统的外科缝合器械 |
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CN201180047047.8A Active CN103124527B (zh) | 2010-09-30 | 2011-09-28 | 包括可生物吸收层的可植入的紧固件仓 |
CN201180047614.XA Active CN103124528B (zh) | 2010-09-30 | 2011-09-28 | 具有可拆卸的支撑结构的外科钉仓 |
CN201180047225.7A Active CN103153202B (zh) | 2010-09-30 | 2011-09-29 | 包括保持矩阵的紧固件系统 |
CN201180047369.2A Active CN103140181B (zh) | 2010-09-30 | 2011-09-29 | 可塌缩的紧固件仓 |
CN201180046991.1A Active CN103140177B (zh) | 2010-09-30 | 2011-09-29 | 包括多个连接的保持矩阵元件的紧固件系统 |
CN2011800472242A Pending CN103153208A (zh) | 2010-09-30 | 2011-09-29 | 包括多个紧固件仓的紧固件系统 |
CN201180047030.2A Active CN103153205B (zh) | 2010-09-30 | 2011-09-29 | 由紧固件仓支撑件支撑的紧固件 |
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