CN104321022A - 包含多种药物的组织厚度补偿件 - Google Patents

包含多种药物的组织厚度补偿件 Download PDF

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Publication number
CN104321022A
CN104321022A CN201380027449.0A CN201380027449A CN104321022A CN 104321022 A CN104321022 A CN 104321022A CN 201380027449 A CN201380027449 A CN 201380027449A CN 104321022 A CN104321022 A CN 104321022A
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China
Prior art keywords
nail
compensating part
tissue thickness
anvil block
tissue
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CN201380027449.0A
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CN104321022B (zh
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C·J·沙伊布
F·E·谢尔顿四世
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Ethicon Endo Surgery Inc
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Ethicon Endo Surgery Inc
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Priority claimed from US13/097,891 external-priority patent/US8864009B2/en
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    • Y10T29/49826—Assembling or joining

Abstract

本发明公开一种组织厚度补偿件，在各种实施例中，补偿件22820可以包括具有多个第一封包22824a和多个第二封包22824b的补偿件主体，其中在至少一个实施例中，每个第二封包定位在两个或多个第一封包中间。所述补偿件还可以包含定位在每个第一封包内的第一药物和定位在每个第二封包内第二药物，其中所述第一药物不同于所述第二药物。

Description

包含多种药物的组织厚度补偿件
背景技术
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。
发明内容
以下为受权利要求书保护或可受权利要求书保护的本发明的实施例的不完全列表。
1.一种补偿件，其能够附接到紧固器械的砧座，其中所述砧座包括成形表面，并且其中所述补偿件包括：
可压缩的补偿件主体，所述补偿件主体包括：
多个第一封包；和
多个第二封包，其中每个第二封包定位在两个或更多个第一封包中间；
定位在每个第一封包内的第一药物；
定位在每个第二封包内的第二药物，其中所述第一药物不同于所述第二药物；以及
能够附接到所述砧座的附接部分。
2.根据实施例1所述的补偿件，其中所述第一药物包含第一粉末并且所述第二药物包含第二粉末。
3.根据实施例1或实施例2所述的补偿件，其中所述第一药物包含藻酸盐并且所述第二药物包含钙。
4.根据前述实施例中任一项所述的补偿件，其中所述补偿件主体包括纵向轴线，并且其中所述第一封包和所述第二封包沿所述纵向轴线以交替布置方式布置。
5.根据前述实施例中任一项所述的补偿件，其中所述第一封包和所述第二封包以交替布置方式布置。
6.根据前述实施例中任一项所述的补偿件，其中所述第一药物包含非织造氧化再生纤维素。
7.一种与缝合器一起使用的缝合组件，所述缝合组件包括：
砧座，其包括：
多个成形表面；和
狭槽，所述狭槽中能够接收切割构件；
附接到所述砧座的补偿件，其中所述补偿件包括与所述狭槽对齐的多个第一封包和与所述狭槽对齐的多个第二封包，并且其中所述第一封包和所述第二封包能够被所述切割构件切割；
定位在每个第一封包内的第一药物；以及
定位在每个第二封包内的第二药物，其中所述第一药物不同于所述第二药物。
8.根据实施例7所述的缝合组件，其中所述狭槽限定用于所述切割构件的路径，并且其中所述第一封包和所述第二封包沿横向于所述路径的方向延伸。
9.根据实施例7或实施例8所述的缝合组件，其中所述补偿件包括能够配合在所述狭槽内的附接部分，并且其中所述附接部分能够被所述切割构件切割。
10.根据实施例7-9中任一项所述的缝合组件，其中所述第一药物包含第一粉末并且所述第二药物包含第二粉末。
11.根据实施例7-10中任一项所述的缝合组件，其中所述第一药物包含藻酸盐并且所述第二药物包含钙。
12.根据实施例7-11中任一项所述的缝合组件，其中所述第一封包和所述第二封包沿所述狭槽以交替布置方式布置。
13.一种与缝合器一起使用的缝合组件，所述缝合组件包括：
砧座，其包括：
多个成形表面；和
纵向狭槽；
能够在所述狭槽内运动的切割构件；
附接到所述砧座的补偿件，其中所述补偿件包括相对于所述狭槽侧向延伸的多个第一侧向腔体和相对于所述狭槽侧向延伸的多个第二侧向腔体，并且其中所述切割构件能够切割所述第一侧向腔体和所述第二侧向腔体；
定位在每个第一侧向腔体内的第一药物；以及
定位在每个第二侧向腔体内的第二药物，其中所述第一药物不同于所述第二药物。
14.根据实施例13所述的缝合组件，其中所述补偿件包括能够配合在所述纵向狭槽内的附接部分，并且其中所述切割构件能够切割所述附接部。
15.根据实施例13或实施例14所述的缝合组件，其中所述第一药物包含第一粉末并且所述第二药物包含第二粉末。
16.根据实施例13-15中任一项所述的缝合组件，其中所述第一药物包含藻酸盐并且所述第二药物包含钙。
17.根据实施例13-16中任一项所述的缝合组件，其中所述第一侧向腔体和所述第二侧向腔体沿所述纵向狭槽以交替布置方式布置。
18.根据实施例13-17中任一项所述的缝合组件，其中所述纵向狭槽限定纵向轴线，并且其中所述第一侧向腔体和所述第二侧向腔体各自限定垂直于所述纵向轴线的侧向轴线。
附图说明
通过结合附图来参考本发明实施例的以下说明，本发明的特征及优点及其获取方法将会变得更加明显，并可更好地理解发明本身，其中：
图1是外科器械实施例的剖视图；
图1A是植入式钉仓的一个实施例的透视图；
图1B-图1E示出了用植入式钉仓夹持和缝合组织的端部执行器的部分；
图2是联接到外科器械的一部分的另一个端部执行器的局部横截面侧视图，其中端部执行器支撑外科钉仓并且其砧座处于打开位置；
图3是处于闭合位置的图2的端部执行器的另一个局部横截面侧视图；
图4是图2和图3的端部执行器在刀杆开始穿过端部执行器推进时的另一个局部横截面侧视图；
图5是图2-图4的端部执行器在刀杆被部分地推进穿过其中时的另一个局部横截面侧视图；
图6A-图6D根据至少一个实施例描绘定位在可塌缩钉仓体内的外科钉的变形；
图7A是示出定位在可压溃钉仓体中的钉的示意图；
图7B是示出图7A的可压溃钉仓体被砧座压溃的示意图；
图7C是示出图7A的可压溃钉仓体被砧座进一步压溃的示意图；
图7D是示出图7A的钉处于完全成形构型并且图7A的可压溃钉仓处于完全压溃条件的示意图；
图8是根据至少一个实施例的钉仓的顶视图，该钉仓包括嵌入可塌缩钉仓体中的钉；
图9是图8的钉仓的正视图；
图10是可压缩钉仓的可供选择的实施例的分解透视图，该可压缩钉仓中包括钉和用于抵靠砧座而驱动钉的系统；
图10A是图10的钉仓的可供选择的实施例的局部剖视图；
图11为图10的钉仓的剖视图；
图12是能够横贯图10的钉仓并使钉朝砧座运动的滑动件的正视图；
图13是钉驱动器的示意图，该钉驱动器可由图12的滑动件朝砧座提升；
图14是根据本发明的至少一个实施例的钉仓的透视图，该钉仓包括与外科缝合器械一起使用的刚性支撑部分和可压缩组织厚度补偿件；
图15是图14的钉仓的局部分解图；
图16是图14的钉仓的完全分解图；
图17是图14的钉仓的另一个分解图，该钉仓没有覆盖组织厚度补偿件的包裹物；
图18是图14的钉仓的仓体或支撑部分的透视图；
图19是滑动件的顶部透视图，该滑动件可在图14的钉仓内运动以从钉仓部署钉；
图20是图19的滑动件的底部透视图；
图21是图19的滑动件的正视图；
图22是驱动器的顶部透视图，该驱动器能够支撑一个或多个钉并被图19的滑动件向上提升以将钉从钉仓射出；
图23是图22的驱动器的底部透视图；
图24是能够至少部分地围绕钉仓的可压缩组织厚度补偿件的包裹物；
图25是钉仓的局部剖视图，该钉仓包括刚性支撑部分和可压缩的组织厚度补偿件，示出了钉在第一序列期间从未击发位置运动到击发位置；
图26是图25的钉仓的正视图；
图27是图25的钉仓的细部正视图；
图28是图25的钉仓的剖面端视图；
图29是图25的钉仓的底视图；
图30是图25的钉仓的细部底视图；
图31是钉仓和处于闭合位置的砧座的纵向剖视图，该钉仓包括刚性支撑部分和可压缩的组织厚度补偿件，示出了钉在第一序列期间从未击发位置运动到击发位置；
图32是图31的砧座和钉仓的另一个剖视图，其示出了击发序列完成之后处于打开位置的砧座；
图33是图31的钉仓的局部细部图，其示出了处于未击发位置的钉；
图34是钉仓的剖面正视图，该钉仓包括刚性支撑部分和可压缩的组织厚度补偿件，示出了处于未击发位置的钉；
图35为图34的钉仓的细部图；
图36是钉仓和处于打开位置的砧座的正视图，该钉仓包括刚性支撑部分和可压缩的组织厚度补偿件，示出了处于未击发位置的钉；
图37是钉仓和处于闭合位置的砧座的正视图，该钉仓包括刚性支撑部分和可压缩的组织厚度补偿件，示出了处于未击发位置的钉以及被捕获在砧座和组织厚度补偿件之间的组织；
图38是图37的砧座和钉仓的细部图；
图39是钉仓和处于闭合位置的砧座的正视图，该钉仓包括刚性支撑部分和可压缩的组织厚度补偿件，示出了处于未击发位置的钉，示出了被定位在砧座和钉仓之间的较厚组织；
图40是图39的砧座和钉仓的细部图；
图41是图39的砧座和钉仓的正视图，其示出了被定位在砧座和钉仓之间的具有不同厚度的组织；
图42是图39的砧座和钉仓的细部图，如图41所示；
图43是示出了对被捕获在不同钉内的不同组织厚度进行补偿的组织厚度补偿件的示意图；
图44是示出了组织厚度补偿件向被钉线横切的一根或多根血管施加压缩压力的示意图；
图45是示出了其中一个或多个钉未恰当成形的情况的示意图；
图46是示出了可补偿未恰当成形钉的组织厚度补偿件的示意图；
图47是示出了被定位在其中多个钉线相交的组织区域中的组织厚度补偿件的示意图；
图48是示出了被捕获在钉内的组织的示意图；
图49是示出了被捕获在钉内的组织和组织厚度补偿件的示意图；
图50是示出了被捕获在钉内的组织的示意图；
图51是示出了被捕获在钉内的厚组织和组织厚度补偿件的示意图；
图52是示出了被捕获在钉内的薄组织和组织厚度补偿件的示意图；
图53是示出了被捕获在钉内的组织厚度补偿件以及具有中间厚度的组织的示意图；
图54是示出了被捕获在钉内的组织厚度补偿件以及具有另一中间厚度的组织的示意图；
图55是示出了被捕获在钉内的厚组织和组织厚度补偿件的示意图；
图56是外科缝合器械的端部执行器的局部剖视图，其示出了处于回缩、未击发位置的击发杆和钉击发滑动件；
图57是图56的端部执行器的另一个局部剖视图，其示出了处于部分推进位置的击发杆和钉击发滑动件；
图58是图56的端部执行器的剖视图，其示出了处于完全推进或击发位置的击发杆；
图59是图56的端部执行器的剖视图，其示出了在被击发后处于回缩位置的击发杆以及留在其完全击发位置的钉击发滑动件；
图60是图59的处于回缩位置的击发杆的细部图；
图61是根据至少一个实施例的包括保持器和两个组织厚度补偿件的保持器组件的分解图；
图62是图61所示的保持器组件的透视图；
图63是可与图61的保持器组件一起使用的砧座的透视图；
图64是示出图61所示的保持器组件的图示，所述保持器组件被插入外科缝合器的端部执行器中，所述端部执行器包括砧座和钉仓；
图65是与图64的钉仓接合的图61所示的保持器组件的侧视图；
图66是与图64的钉仓和砧座接合的图61所示的保持器组件的侧视图，其示出了处于闭合位置的砧座；
图67是从图64的端部执行器移出的图61的保持器组件的侧视图；
图68是保持器的透视图；
图69是图68的保持器以及附接到其底部表面和顶部表面的组织厚度补偿件的侧视图，其示出了与包括砧座的外科缝合器中的钉仓接合的组织厚度补偿件中的一个；
图70是示出处于闭合位置的图69的砧座的侧视图；
图71是根据至少一个实施例的保持器和组织厚度补偿件的分解透视图；
图72是图71的组织厚度补偿件和外科缝合器的砧座的分解透视图；
图73是根据至少一个实施例的保持器和组织厚度补偿件的分解顶部透视图；
图74是图73的保持器和组织厚度补偿件的分解底部透视图；
图75是与外科缝合器接合的图73的保持器和组织厚度补偿件的顶部透视图；
图76是与图75的外科缝合器接合的图73的保持器和组织厚度补偿件的底部透视图；
图77是与图75的外科缝合器接合的图73的保持器和组织厚度补偿件的侧视图；
图78是图73的保持器和组织厚度补偿件的底部透视图，其示出了附接到图75的外科缝合器的组织厚度补偿件；
图79是图73的保持器和组织厚度补偿件的顶部透视图，其示出了附接到图78的砧座的组织厚度补偿件；
图80是附接到图78的砧座的图73的组织厚度补偿件的侧视图；
图81是附接到外科缝合器的钉仓和通道的图73和图74的保持器和组织厚度补偿件的剖视图；
图82是附接到图81的外科缝合器的钉仓和通道的图73和图74的保持器和组织厚度补偿件的剖视图，其示出了与组织厚度补偿件接合的外科缝合器的砧座；
图83是附接到外科缝合器的砧座并且正移动远离保持器的图73的组织厚度补偿件的剖视图；
图84是根据至少一个实施例的保持器组件的剖视图，所述保持器组件包括保持器、安装在保持器的第一表面和第二表面上的组织厚度补偿件、和穿过保持器中的孔的连接器；
图85是图84的保持器组件的透视图，其中示出组织厚度补偿件的一部分因图示目的而被移除；
图86是与外科缝合器接合的图84的保持器组件的侧视图，所述外科缝合器包括被示为处于打开位置的砧座；
图87是图84的保持器组件和被示为处于闭合位置的图86的砧座的侧视图；
图88是图84的保持器组件的侧视图，其示出了正从保持器组件的组织厚度补偿件之间移出的保持器；
图89是从图84的组织厚度补偿件移出的保持器的侧视图；
图90是根据至少一个实施例的能够接合外科缝合器的砧座的保持器的透视图；
图91是图90的保持器的顶视图；
图92是图90的保持器的侧视图；
图93是图90的保持器的底视图；
图94示出了保持器组件，所述保持器组件包括图90的保持器和附接到用于外科缝合器的钉仓的组织厚度补偿件；
图95示出了接合外科缝合器的端部执行器的砧座的图94的保持器组件和钉仓；
图96示出了接合图95的外科缝合器的端部执行器的砧座的图94的保持器组件和钉仓；
图97示出了接合在图95的外科缝合器的砧座上的图94的保持器组件和钉仓；
图98示出了接合在图95的外科缝合器的砧座上的图94的保持器组件和钉仓以及正移动到闭合位置的砧座；
图99示出了处于打开位置的图95的外科缝合器的砧座，所述砧座具有附接到其的组织厚度补偿件和与外科缝合器的钉仓通道接合的保持器；
图100示出了与图95的外科缝合器的钉仓通道接合的图94的保持器和处于打开位置的砧座；
图101是包括组织厚度补偿件的保持器的剖视图，所述组织厚度补偿件包括能够接合外科缝合器的砧座的突起或翼部；
图102是包括组织厚度补偿件的保持器的剖视图，所述组织厚度补偿件包括能够接合外科缝合器的砧座的承套；
图103是根据至少一个实施例的包括由铰链连接的两个板的保持器的透视图；
图104是图103的保持器的侧视图；
图105是能够与图103的保持器一起使用的插入工具的实施例的后透视图；
图106是图105的插入工具的顶部透视图；
图107是图105的插入工具的后透视图，其中插入工具的一部分因图示目的而被移除；
图108是图105的插入工具的侧视图，其中插入工具的一部分因图示目的而被移除；
图109是图105的插入工具的顶视图；
图110是保持器组件的透视图，所述保持器组件包括图103的保持器、定位在保持器上的组织厚度补偿件、定位在保持器上的钉仓、以及与保持器接合的图105的插入工具，其中插入工具的一部分因图示目的而被移除；
图111是保持器组件的侧视图，所述保持器组件包括图103的保持器、定位在保持器上的组织厚度补偿件、以及与保持器接合的图105的插入工具，其中插入工具的一部分因图示目的而被移除；
图112示出了被插入包括砧座和钉仓通道的外科器械内的图110的保持器组件，其中插入工具的一部分因图示目的而被移除；
图113示出了被插入包括砧座和钉仓通道的外科器械内的图110的保持器组件，其中插入工具的一部分因图示目的而被移除；
图114示出了正相对于保持器移动以接合钉仓通道中的钉仓并且接合随同砧座的组织厚度补偿件的图105的插入工具，其中插入工具的一部分因图示目的而被移除；
图115示出了正相对于保持器移动以使保持器从组织厚度补偿件和钉仓脱离的图105的插入工具，其中插入工具的一部分因图示目的而被移除；
图116是根据至少一个实施例的附接到外科缝合器械的砧座的组织厚度补偿件的剖视图；
图117是示出变形钉的示意图，所述变形钉在其中至少部分地捕获图116的组织厚度补偿件；
图118是根据至少一个实施例的包括钉仓和砧座的外科缝合器械的端部执行器的剖视图，所述钉仓包括第一组织厚度补偿件，所述砧座包括第二组织厚度补偿件；
图119是图118的端部执行器的剖视图，其示出了得自钉仓的从未击发位置移动到击发位置的钉；
图120是根据至少一个实施例的附接到端部执行器的砧座的组织厚度补偿件的透视图，其中组织厚度补偿件包括多个胶囊；
图120A是图120的组织厚度补偿件的局部透视图；
图121是正从未击发位置移动到击发位置以刺穿图120的组织厚度补偿件的胶囊的钉的剖视图；
图122是根据至少一个实施例的砧座和组织厚度补偿件的分解图；
图123是根据至少一个实施例的砧座和组织厚度补偿件的剖视图，所述砧座包括多个钉成形凹坑，所述组织厚度补偿件包括与成形凹坑对齐的多个胶囊；
图124是图123的组织厚度补偿件的胶囊的细部图；
图125是示出相对于组织进行定位的图123的砧座和组织厚度补偿件的示意图，所述组织将通过得自定位在组织的相对侧的钉仓的钉进行缝合；
图126是示出正朝图125的钉仓移动的图123的砧座和从钉仓部分地击发的钉的示意图；
图127是示出处于完全击发构型的图126的钉和处于破裂状态的图123的组织厚度补偿件的胶囊的示意图；
图128是示出处于未击发状态的图126的钉的示意图；
图129是示出处于完全击发构型的图126的钉和处于至少部分横切状态的图123的组织厚度补偿件的示意图；
图130是根据至少一个实施例的组织厚度补偿件的可供选择的实施例的剖面透视图；
图131是组织厚度补偿件的可供选择的实施例的透视图，所述组织厚度补偿件包括与外科缝合器械的切割构件对齐的多个胶囊；
图132是图131的胶囊的细部图；
图133是图131的组织厚度补偿件的剖视图，所述组织厚度补偿件包括与外科缝合器械的砧座的刀狭槽对齐的多个胶囊；
图134和图135示出了正附接到砧座的组织厚度补偿件的可供选择的实施例；
图136是根据至少一个实施例的砧座和补偿件的剖面分解图；
图137示出了附接到砧座的图136的补偿件；
图138是根据至少一个实施例的组织厚度补偿件和切割组织厚度补偿件的切割构件的局部透视图；
图139是根据至少一个实施例的组织厚度补偿件的可供选择的实施例的局部剖视图；
图140是根据至少一个实施例的组织厚度补偿件的另一个可供选择的实施例的局部剖视图；
图141是示出根据各种实施例的组织厚度补偿件的示意图，所述组织厚度补偿件包括多个不规则和/或非对称的腔体；
图142是根据至少一个实施例的附接到外科缝合器械的砧座的组织厚度补偿件的局部剖视图；
图143是根据至少一个实施例的组织厚度补偿件的无缝挤出壳体或外管的透视图；
图144是根据至少一个实施例的组织厚度补偿件的另一个无缝挤出壳体或外管的透视图；
图145是氧化再生纤维素纤维的透视图；
图146是短于图145的纤维的氧化再生纤维素纤维的透视图；
图147是示出正利用图146的纤维织造成股线的图145的纤维的示意图；
图148示出了正被松散并且正被至少部分地切割的图147的股线；
图149示出了插过组织厚度补偿件的壳体或外管并且被定位成抓紧图147的股线的抓紧器；
图150示出了正从套管退出的图149的抓紧器和正被牵拉穿过壳体的图147的股线；
图151示出了正被分割的图150的壳体和股线；
图152示出了正进行加热焊接和/或密封的壳体的末端；
图153示出了用于产生不具有横向接缝的组织厚度补偿件的方法；
图154示出了外科缝合器的砧座和可选择性地附接到砧座的多个补偿件，其中补偿件中的每一个包括毛细管通道阵列；
图155是能够附接到砧座的补偿件的平面图；
图156是图155的补偿件的一部分的细部图；
图157是外科缝合器械的端部执行器的透视图；
图158是图157的端部执行器的另一个透视图，其示出了布置在端部执行器的组织厚度补偿件上的流体；
图159是图159的端部执行器的另一个透视图，其示出了附接到端部执行器的砧座的补偿件；
图160是位于图159的补偿件上的毛细管通道阵列的细部图；
图161是根据至少一个实施例的包括多个层的补偿件的分解图；
图162是根据至少一个实施例的外科缝合器械的补偿件和砧座的分解图；
图163是图162的补偿件和砧座的局部剖视图；
图164是根据至少一个实施例的包括细胞向内生长基质的补偿件的分解图；
图165是图164的补偿件的透视图；
图166是用于补偿件的纤维材料层的透视图；
图167是根据至少一个实施例的彼此堆叠在一起的多个纤维层的透视图；
图168是根据至少一个实施例的彼此堆叠在一起的另一多个纤维层的透视图；
图169是用于补偿件的纤维材料层的透视图；
图170是根据至少一个实施例的彼此堆叠在一起的多个纤维层的透视图，其中所述纤维沿着不同方向进行布置；
图171是根据至少一个实施例的彼此堆叠在一起的另一多个纤维层的透视图；
图172是根据至少一个实施例的外科器械的端部执行器插入件和端部执行器的透视图；
图173是根据至少一个实施例的定位在外科器械的端部执行器中的组织厚度补偿件的正视图；
图174是根据至少一个实施例的定位在外科器械的端部执行器中的组织厚度补偿件的正视图；
图175是根据至少一个实施例的定位在外科器械的端部执行器的砧座上的套管的透视图；
图176是图175的套管的分叉部的平面图；
图177是图175的套管的分叉部的正视图；
图178是图175的套管的分叉部的端视图；
图179是图175的套管的分叉部的透视图；
图180是根据至少一个实施例的套管的组织补偿件的平面图；
图181是图180的组织补偿件的透视图；
图182是图180的组织补偿件的正视图；
图183是根据至少一个实施例的套管的组织补偿件的平面图；
图184是图183的组织补偿件的透视图；
图185是图183的组织补偿件的正视图；
图186是图175的套管的鼻部的透视图；
图187是图186的鼻部的另一个透视图；
图188是图186的鼻部的平面图，其以虚线示出了内部几何形状；
图189是图186的鼻部的正视图，其以虚线示出了内部几何形状；
图190是定位在砧座上的图175的套管的另一个透视图；
图191是定位在砧座上的图175的套管的平面图；
图192是定位在砧座上的图175的套管的正视图；
图193是定位在砧座上的图175的套管的平面图，其示出了以虚线显示的平移击发杆；
图194是定位在砧座上的图175的套管的正视图，其示出了以虚线显示的平移击发杆；
图195是定位在砧座上的图175的套管的平面图，其示出了从套管释放的鼻部；
图196是定位在砧座上的图175的套管的正视图，其示出了从套管释放的鼻部；
图197是定位在砧座上的图175的套管的平面图，其以虚线示出了击发杆并且示出了从套管释放的鼻部；
图198是定位在砧座上的图175的套管的正视图，其以虚线示出了击发杆并且示出了从套管释放的鼻部；
图199是图197的套管、砧座、和击发杆的局部透视图；
图200是图197的套管、砧座、和击发杆的另一个局部透视图；
图201是图175的套管和砧座的正剖视图；
图202是图175的砧座的正剖视图，其示出了从套管释放的组织补偿件；
图203是根据至少一个实施例的端部执行器插入件的平面图；
图204是图203的端部执行器插入件的正视图；
图205是图205的端部执行器插入件的透视图；
图206是图203的端部执行器插入件的局部透视图，其示出了接合外科器械的端部执行器的砧座的端部执行器插入件；
图207是图203的端部执行器插入件的局部透视图，其示出了接合外科器械的端部执行器的钉仓的端部执行器插入件；
图208是图203的端部执行器插入件的正视图，其示出了接合外科器械的端部执行器的端部执行器插入件；
图209是定位在外科器械的端部执行器中的图203的端部执行器插入件的正视图；
图210是根据至少一个实施例的定位在端部执行器中的组织厚度补偿件的透视图，其中示出组织厚度补偿件的一部分被切除；
图211是通过静电荷固定到端部执行器的砧座的图210的组织厚度补偿件的透视图；
图212是通过抽吸元件固定到端部执行器的砧座的图210的组织厚度补偿件的透视图；
图213是通过钩-环紧固件固定到端部执行器的砧座的图210的组织厚度补偿件的透视图；
图214是通过带固定到端部执行器的砧座的图210的组织厚度补偿件的局部透视图；
图215是通过组织厚度补偿件的远侧末端处的承套固定到端部执行器的砧座的图210的组织厚度补偿件的局部透视图；
图216是根据至少一个实施例的固定到外科器械的端部执行器的砧座的组织厚度补偿件的局部透视剖视图；
图217是图216的组织厚度补偿件的正剖视图；
图218是图216的组织厚度补偿件的另一个正剖视图；
图219是根据至少一个实施例的固定到外科器械的端部执行器的砧座的组织厚度补偿件的正剖视图，其示出了处于闭合位置的闩锁；
图220是图219的组织厚度补偿件的正剖视图，其示出了处于打开位置的闩锁；
图221是根据至少一个实施例的固定到外科器械的端部执行器的砧座的组织厚度补偿件的正剖视图；
图222是根据至少一个实施例的固定到外科器械的端部执行器的砧座的组织厚度补偿件的正剖视图；
图223是根据至少一个实施例的固定到外科器械的端部执行器的砧座的组织厚度补偿件的正剖视图；
图224是根据至少一个实施例的固定到外科器械的端部执行器的砧座的组织厚度补偿件的正剖视图；
图225是根据至少一个实施例的固定到外科器械的端部执行器的砧座的组织厚度补偿件的透视剖视分解图；
图226是图225的组织厚度补偿件的透视图，其示出了朝砧座移动的组织厚度补偿件；
图227是与砧座接合的图225的组织厚度补偿件的正剖视图；
图228是根据至少一个实施例的固定到外科器械的端部执行器的砧座的组织厚度补偿件的透视剖视图；
图229是图228的组织厚度补偿件和砧座的透视剖视分解图；
图230是根据至少一个实施例的组织厚度补偿件的正视图；
图231是图230的组织厚度补偿件的透视图；
图232是图230的组织厚度补偿件的另一个透视图；
图233是图230的组织厚度补偿件的透视图，其示出了朝外科器械的端部执行器的砧座移动的组织厚度补偿件；
图234是定位在砧座上的图230的组织厚度补偿件的剖视图；
图235是定位在砧座上的图230的组织厚度补偿件的透视图；
图236是定位在砧座上的图230的组织厚度补偿件的透视图，其示出了切断组织厚度补偿件的切割元件；
图237是根据至少一个实施例的外科缝合器械的端部执行器的剖视正视图，所述端部执行器包括砧座和充电层；
图238是图237的砧座和充电层的底视图；
图239是图237的砧座和充电层以及可释放地附接到充电层的组织厚度补偿件的分解图；
图240是根据至少一个实施例的组织厚度补偿件的透视图；
图241是图240的组织厚度补偿件的平面图；
图240A是根据至少一个可供选择的实施例的组织厚度补偿件的透视图；
图241A是图240A的组织厚度补偿件的平面图；
图242是根据至少一个可供选择的实施例的组织厚度补偿件的透视图；
图243是图242的组织厚度补偿件的平面图；
图244是根据至少一个实施例的组织厚度补偿件的透视图；
图245是根据至少一个实施例的附接到砧座的组织厚度补偿件的透视图；
图246是图245的砧座和组织厚度补偿件的剖视图；
图247是图245的组织厚度补偿件的横截面图；
图248是根据至少一个可供选择的实施例的附接到砧座的组织厚度补偿件的透视图；
图249是图248的砧座和组织厚度补偿件的剖视图；
图250是处于打开构型的图248的组织厚度补偿件的剖视图；
图251是根据至少一个可供选择的实施例的附接到砧座的组织厚度补偿件的透视图；
图252是图251的砧座和组织厚度补偿件的剖视图；
图253是根据至少一个可供选择的实施例的附接到砧座的组织厚度补偿件的透视图；
图254是图253的砧座和组织厚度补偿件的剖视图；
图255是根据至少一个可供选择的实施例的附接到砧座的组织厚度补偿件的透视图；
图256是图255的砧座和组织厚度补偿件的剖视图；
图257是根据至少一个可供选择的实施例的附接到砧座的组织厚度补偿件的透视图；并且
图258是图257的砧座和组织厚度补偿件的剖视图。
贯穿多个视图，对应的参考符号指示对应的部件。本文示出的范例以一种形式示出了本发明的某些实施例，并且不应将此类范例理解为以任何方式限制本发明的范围。
具体实施方式
本申请的申请人还拥有以下的美国专利申请，这些专利申请以引用的方式各自完全并入本文：
名称为“SURGICAL INSTRUMENTS WITH RECONFIGURABLESHAFT SEGMENTS”(代理人案卷号END6734USNP/100058)的美国专利申请序列号12/894,311；
名称为“SURGICAL STAPLE CARTRIDGES SUPPORTING NON-LINEARLY ARRANGED STAPLES AND SURGICAL STAPLINGINSTRUMENTS WITH COMMON STAPLE-FORMING POCKETS”(代理人案卷号END6735USNP/100059)的美国专利申请序列号12/894,340；
名称为“JAW CLOSURE ARRANGEMENTS FOR SURGICALINSTRUMENTS”(代理人案卷号END6736USNP/100060)的美国专利申请序列号12/894,327；
名称为“SURGICAL CUTTING AND FASTENING INSTRUMENTSWITH SEPARATE AND DISTINCT FASTENER DEPLOYMENT ANDTISSUE CUTTING SYSTEMS”(代理人案卷号END6839USNP/100524)的美国专利申请序列号12/894,351；
名称为“IMPLANTABLE FASTENER CARTRIDGE HAVING A NON-UNIFORM ARRANGEMENT”(代理人案卷号END6840USNP/100525)的美国专利申请序列号12/894,338；
名称为“IMPLANTABLE FASTENER CARTRIDGE COMPRISING ASUPPORT RETAINER”(代理人案卷号END6841USNP/100526)的美国专利申请序列号12/894,369；
名称为“IMPLANTABLE FASTENER CARTRIDGE COMPRISINGMULTIPLE LAYERS”(代理人案卷号END6842USNP/100527)的美国专利申请序列号12/894,312；
名称为“SELECTIVELY ORIENTABLE IMPLANTABLE FASTENERCARTRIDGE”(代理人案卷号END6843USNP/100528)的美国专利申请序列号12/894,377；
名称为“SURGICAL STAPLING INSTRUMENT WITH COMPACTARTICULATION CONTROL ARRANGEMENT”(代理人案卷号END6847USNP/100532)的美国专利申请序列号12/894,339；
名称为“SURGICAL STAPLING INSTRUMENT WITH A VARIABLESTAPLE FORMING SYSTEM”(代理人案卷号END6848USNP/100533)的美国专利申请序列号12/894,360；
名称为“SURGICAL STAPLING INSTRUMENT WITHINTERCHANGEABLE STAPLE CARTRIDGE ARRANGEMENTS”(代理人案卷号END6849USNP/100534)的美国专利申请序列号12/894,322；
名称为“SURGICAL STAPLE CARTRIDGES WITH DETACHABLESUPPORT STRUCTURES AND SURGICAL STAPLING INSTRUMENTSWITH SYSTEMS FOR PREVENTING ACTUATION MOTIONS WHEN ACARTRIDGE IS NOT PRESENT”(代理人案卷号END6855USNP/100540)的美国专利申请序列号12/894,350；
名称为“IMPLANTABLE FASTENER CARTRIDGE COMPRISINGBIOABSORBABLE LAYERS”(代理人案卷号END6856USNP/100541)的美国专利申请序列号12/894,383；
名称为“COMPRESSIBLE FASTENER CARTRIDGE”(代理人案卷号END6857USNP/100542)的美国专利申请序列号12/894,389；
名称为“FASTENERS SUPPORTED BY A FASTENER CARTRIDGESUPPORT”(代理人案卷号END6858USNP/100543)的美国专利申请序列号12/894,345；
名称为“COLLAPSIBLE FASTENER CARTRIDGE”(代理人案卷号END6859USNP/100544)的美国专利申请序列号12/894,306；
名称为“FASTENER SYSTEM COMPRISING A PLURALITY OFCONNECTED RETENTION MATRIX ELEMENTS”(代理人案卷号END6860USNP/100546)的美国专利申请序列号12/894,318；
名称为“FASTENER SYSTEM COMPRISING A RETENTION MATRIXAND AN ALIGNMENT MATRIX”(代理人案卷号END6861USNP/100547)的美国专利申请序列号12/894,330；
名称为“FASTENER SYSTEM COMPRISING A RETENTIONMATRIX”(代理人案卷号END6862USNP/100548)的美国专利申请序列号12/894,361；
名称为“FASTENER SYSTEM COMPRISING A RETENTIONMATRIX”(代理人案卷号END6863USNP/100549)的美国专利申请序列号12/894,367；
名称为“FASTENER SYSTEM COMPRISING A RETENTION MATRIXAND A COVER”(代理人案卷号END6864USNP/100550)的美国专利申请序列号12/894,388；
名称为“FASTENER SYSTEM COMPRISING A PLURALITY OFFASTENER CARTRIDGES”(代理人案卷号END6865USNP/100551)的美国专利申请序列号12/894,376；
名称为“SURGICAL STAPLER ANVIL COMPRISING A PLURALITYOF FORMING POCKETS”(代理人案卷号END6735USCIP1/100059CIP1)的美国专利申请序列号13/097,865；
名称为“TISSUE THICKNESS COMPENSATOR FOR A SURGICALSTAPLER”(代理人案卷号END6736USCIP1/100060CIP1)的美国专利申请序列号13/097,936；
名称为“STAPLE CARTRIDGE COMPRISING A VARIABLETHICKNESS COMPRESSIBLE PORTION”(代理人案卷号END6840USCIP1/100525CIP1)的美国专利申请序列号13/097,954；
名称为“STAPLE CARTRIDGE COMPRISING STAPLES POSITIONEDWITHIN A COMPRESSIBLE PORTION THEREOF”(代理人案卷号END6841USCIP1/100526CIP1)的美国专利申请序列号13/097,856；
名称为“TISSUE THICKNESS COMPENSATOR COMPRISINGDETACHABLE PORTIONS”(代理人案卷号END6842USCIP1/100527CIP1)的美国专利申请序列号13/097,928；
名称为“TISSUE THICKNESS COMPENSATOR FOR A SURGICALSTAPLER COMPRISING AN ADJUSTABLE ANVIL”(代理人案卷号END6843USCIP1/100528CIP1)的美国专利申请序列号13/097,891；
名称为“STAPLE CARTRIDGE COMPRISING AN ADJUSTABLEDISTAL PORTION”(代理人案卷号END6847USCIP1/100532CIP1)的美国专利申请序列号13/097,948；
名称为“COMPRESSIBLE STAPLE CARTRIDGE ASSEMBLY”(代理人案卷号END6848USCIP1/100533CIP1)的美国专利申请序列号13/097,907；
名称为“TISSUE THICKNESS COMPENSATOR COMPRISINGPORTIONS HAVING DIFFERENT PROPERTIES”(代理人案卷号END6849USCIP1/100534CIP1)的美国专利申请序列号13/097,861；
名称为“STAPLE CARTRIDGE LOADING ASSEMBLY”(代理人案卷号END6855USCIP1/100540CIP1)的美国专利申请序列号13/097,869；
名称为“COMPRESSIBLE STAPLE CARTRIDGE COMPRISINGALIGNMENT MEMBERS”(代理人案卷号END6856USCIP1/100541CIP1)的美国专利申请序列号13/097,917；
名称为“STAPLE CARTRIDGE COMPRISING A RELEASABLEPORTION”(代理人案卷号END6857USCIP1/100542CIP1)的美国专利申请序列号13/097,873；
名称为“STAPLE CARTRIDGE COMPRISING COMPRESSIBLEDISTORTION RESISTANT COMPONENTS”(代理人案卷号END6858USCIP1/100543CIP1)的美国专利申请序列号13/097,938；
名称为“STAPLE CARTRIDGE COMPRISING A TISSUE THICKNESSCOMPENSATOR”(代理人案卷号END6859USCIP1/100544CIP1)的美国专利申请序列号13/097,924；
名称为“SURGICAL STAPLER WITH FLOATING ANVIL”(代理人案卷号END6841USCIP2/100526CIP2)的美国专利申请序列号13/242,029；
名称为“CURVED END EFFECTOR FOR A STAPLINGINSTRUMENT”(代理人案卷号END6841USCIP3/100526CIP3)的美国专利申请序列号13/242,066；
名称为“STAPLE CARTRIDGE INCLUDING COLLAPSIBLE DECK”(代理人案卷号END7020USNP/110374)的美国专利申请序列号13/242,086；
名称为“STAPLE CARTRIDGE INCLUDING COLLAPSIBLE DECKARRANGEMENT”(代理人案卷号END7019USNP/110375)的美国专利申请序列号13/241,912；
名称为“SURGICAL STAPLER WITH STATIONARY STAPLEDRIVERS”(代理人案卷号END7013USNP/110377)的美国专利申请序列号13/241,922；
名称为“SURGICAL INSTRUMENT WITH TRIGGER ASSEMBLY FORGENERATING MULTIPLE ACTUATION MOTIONS”(代理人案卷号END6888USNP3/110378)的美国专利申请序列号13/241,637；和
名称为“SURGICAL INSTRUMENT WITH SELECTIVELYARTICULATABLE END EFFECTOR”(代理人案卷号END6888USNP2/110379)的美国专利申请序列号13/241,629。
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：
名称为“TISSUE THICKNESS COMPENSATOR COMPRISING APLURALITY OF CAPSULES”(代理人案卷号END6864USCIP1/100550CIP1)的美国专利申请序列号_______________；
名称为“TISSUE THICKNESS COMPENSATOR COMPRISING APLURALITY OF LAYERS”(代理人案卷号END6864USCIP2/100550CIP2)的美国专利申请序列号_______________；
名称为“EXPANDABLE TISSUE THICKNESS COMPENSATOR”(代理人案卷号END6843USCIP2/100528CIP2)的美国专利申请序列号_______________。
名称为“TISSUE THICKNESS COMPENSATOR COMPRISING ARESERVOIR”(代理人案卷号END6843USCIP3/100528CIP3)的美国专利申请序列号_______________；
名称为“RETAINER ASSEMBLY INCLUDING A TISSUE THICKNESSCOMPENSATOR”(代理人案卷号END6843USCIP4/100528CIP4)的美国专利申请序列号_______________；
名称为“TISSUE THICKNESS COMPENSATOR COMPRISING ATLEAST ONE MEDICAMENT”(代理人案卷号END6843USCIP5/100528CIP5)的美国专利申请序列号_______________；
名称为“TISSUE THICKNESS COMPENSATOR COMPRISINGCONTROLLED RELEASE AND EXPANSION”(代理人案卷号END6843USCIP6/100528CIP6)的美国专利申请序列号_______________；
名称为“TISSUE TISSUE THICKNESS COMPENSATOR COMPRISINGFIBERS TO PRODUCE A RESILIENT LOAD”(代理人案卷号END6843USCIP7/100528CIP7)的美国专利申请序列号_______________；
名称为“TISSUE TISSUE THICKNESS COMPENSATOR COMPRISINGSTRUCTURE TO PRODUCE A RESILIENT LOAD”(代理人案卷号END6843USCIP8/100528CIP8)的美国专利申请序列号_______________；
名称为“TISSUE TISSUE THICKNESS COMPENSATOR COMPRISINGRESILIENT MEMBERS”(代理人案卷号END6843USCIP9/100528CIP9)的美国专利申请序列号_______________；
名称为“METHODS FOR FORMING TISSUE THICKNESSCOMPENSATOR ARRANGEMENTS FOR SURGICAL STAPLERS”(代理人案卷号END6843USCIP10/100528CP10)的美国专利申请序列号_______________；
名称为“TISSUE THICKNESS COMPENSATORS”(代理人案卷号END6843USCIP11/100528CP11)的美国专利申请序列号_______________；
名称为“LAYERED TISSUE THICKNESS COMPENSATOR”(代理人案卷号END6843USCIP12/100528CP12)的美国专利申请序列号_______________；
名称为“TISSUE THICKNESS COMPENSATORS FOR CIRCULARSURGICAL STAPLERS”(代理人案卷号END6843USCIP13/100528CP13)的美国专利申请序列号_______________；
名称为“TISSUE TISSUE THICKNESS COMPENSATOR COMPRISINGCAPSULES DEFINING A LOW PRESSURE ENVIRONMENT”(代理人案卷号END7100USNP/110601)的美国专利申请序列号_______________；
名称为“TISSUE THICKNESS COMPENSATOR COMPRISED OF APLURALITY OF MATERIALS”(代理人案卷号END7101USNP/110602)的美国专利申请序列号_______________；
名称为“MOVABLE MEMBER FOR USE WITH A TISSUETHICKNESS COMPENSATOR”(代理人案卷号END7107USNP/110603)的美国专利申请序列号_______________；
名称为“TISSUE TISSUE THICKNESS COMPENSATOR ANDMETHOD FOR MAKING THE SAME”(代理人案卷号END7103USNP/110605)的美国专利申请序列号_______________；
名称为“TISSUE TISSUE THICKNESS COMPENSATOR COMPRISINGCHANNELS”(代理人案卷号END7104USNP/110606)的美国专利申请序列号_______________；
名称为“TISSUE TISSUE THICKNESS COMPENSATOR COMPRISINGTISSUE INGROWTH FEATURES”(代理人案卷号END7105USNP/110607)的美国专利申请序列号_______________；和
名称为“DEVICES AND METHODS FOR ATTACHING TISSUETHICKNESS COMPENSATING MATERIALS TO SURGICAL STAPLINGINSTRUMENTS”(代理人案卷号END7106USNP/110608)的美国专利申请序列号_______________。
现在将描述某些示例性实施例，以从整体上理解本文所公开的装置和方法的结构、功能、制造和用途。这些实施例的一个或多个实例在附图中示出。本领域普通技术人员应当理解文中具体描述并用附图示出的装置与方法均为非限制的示例性实施例。结合一个示例性实施例示出或描述的结构可与其它实施例的结构相组合。这种修改形式和变型形式包括在本发明的范围内。
本文公开的或受权利要求书保护的用于制造、形成或换句话讲制备制品或产品的方法中的任何一个可用于制造、形成或换句话讲制备所考虑的制品或产品中的全部或部分，并且在此类方法用于制造、形成或换句话讲制备所考虑的制品或产品的部分的情况下，制品或产品的其余部分可以任何方式(包括使用本文公开的或受权利要求书保护的用于制造、形成或换句话讲制备制品或产品的其它方法中的任何一个)来制备，并且可将如此制备的各个部分以任何方式进行组合。相似地，本文公开的或受权利要求书保护的任何制品或产品可单独存在，或者可结合与其兼容的本发明所公开的任何其它制品或产品而存在，或者可作为与其兼容的本发明所公开的任何其它制品或产品的一体部分而存在。因此，结合一种制品、产品或方法示出或描述的特定特征、结构、或特性可完全地或部分地(非限制地)与一种或多种其它兼容制品、产品或方法的特征、结构、或特性进行结合。这种修改形式和变型形式包括在本发明的范围内。
在本文参照特定附图或其它方式公开本发明的特定实施例，或者特定制品，产品或方法可包括特定结构、特性、或特征的情况下，读者应当理解，这意味着这些结构、特性、或特征可以任何合适的组合实施于所考虑的制品、产品或方法中。具体地讲，多个任选结构、特性、或特征的此类公开内容应被理解为公开这些结构、特性、或特征的全部组合，例外情况是被公开作为彼此的替代形式的结构、特性、或特征。在此类结构、特性、或特征被公开作为彼此的替代形式的情况下，这应被理解为公开作为彼此的替换物的这些替代形式。
本文所用术语“近侧”和“远侧”是相对于操纵外科器械的柄部部分的临床医生而言的。术语“近侧”是指最靠近临床医生的部分，术语“远侧”是指远离临床医生的部分。还应当理解，为简洁和清楚起见，本文可以结合附图使用诸如“竖直”、“水平”、“上”和“下”之类的空间术语。然而，外科器械在许多方向和位置中使用，并且这些术语并非限制性的和/或绝对的。
提供了各种示例性装置和方法以执行腹腔镜式和微创外科手术操作。然而，读者将容易理解，本文所公开的各种方法和装置可用于多种外科手术和应用(包括与开放式外科手术结合)中。继续参阅本具体实施方式，读者将进一步理解，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和细长轴可通过所述工作通道推进。
转到附图，其中在多个视图中，类似的数字表示类似的组件，图1示出了能够实践若干独特益处的外科器械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其上的各种形式及尺寸的端部执行器12。在图1-图1E中，例如端部执行器12包括细长通道14，该细长通道形成端部执行器12的下钳口13。细长通道14能够支撑“植入式”钉仓30并且还能够运动地支撑用作端部执行器12的上钳口15的砧座20。
细长通道14可由例如300&400系列，17-4&17-7不锈钢、钛等制成，并且可与间隔开的侧壁16一起形成。砧座20可由例如300&400系列，17-4&17-7不锈钢、钛等制成，并且可具有钉成形下表面(通常标记为22)，所述钉成形下表面具有形成于其中的多个钉成形凹坑23。参见图1B-图1E。另外，砧座20具有从其向近侧突起的分为两部分的滑道组件24。砧座销26从滑道组件24的每个侧面突起，以接收在细长通道14的侧壁16中的对应狭槽或开口18内，从而有利于将砧座销可运动或可枢转地附接到所述对应狭槽或开口上。
各种形式的植入式钉仓可与本文所公开的外科器械一起使用。以下将更详细地论述特定的钉仓构型和构造。然而，在图1A中，示出了植入式钉仓30。钉仓30具有主体部分31，该主体部分由可压缩的止血材料(诸如氧化再生纤维素(“ORC”)或可生物吸收的泡沫)构成，其中支撑有多行未成形的金属钉32。为防止钉受影响并且防止止血材料在引入和定位过程期间被活化，整个仓可涂覆有或包裹有可生物降解的膜38，诸如以商标出售的六环酮膜或聚甘油癸二酸酯(PGS)膜或由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的复合物形成的其他可生物降解的膜，所述膜只有在破裂时才可渗透。钉仓30的主体31的尺寸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，其中的每个钉32均与砧座中对应的钉成形凹坑23对齐。
在使用中，一旦端部执行器12邻近靶组织而定位，端部执行器12便被操纵成将靶组织捕获或夹紧于钉仓30的顶部表面36与砧座20的钉成形表面22之间。钉32通过如下方式成形：使砧座20在基本上平行于细长通道14的路径中运动，以使钉成形表面22且更具体地使其中的钉成形凹坑23基本上同时接触钉仓30的顶部表面36。当砧座20继续运动至钉仓30中时，钉32的腿34在砧座20中接触对应的钉成形凹坑23，该钉成形凹坑用于使钉腿34弯曲以使钉32成形为“B形”。砧座20朝细长通道14的进一步运动将进一步压缩钉32以使其成形为期望的最终成形高度“FF”。
上述钉成形过程大体绘示于图1B-图1E中。例如，图1B示出端部执行器12，其中靶组织“T”位于砧座20与植入式钉仓30的顶部表面36之间。图1C示出砧座20的初始夹紧位置，其中砧座20已被合拢至靶组织“T”上，以将靶组织“T”夹紧于砧座20与钉仓30的顶部表面36之间。图1D示出初始钉成形，其中砧座20已开始压缩钉仓30，使得钉32的腿34开始通过砧座20中的钉成形凹坑23而成形。图1E示出穿过靶组织“T”而处于最终成形条件的钉32，为清晰起见已移除砧座20。一旦钉32成形并紧固至靶组织“T”，外科医生便使砧座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及钉32能够保持附连到靶组织。当两个钳口13,15共同夹紧时，端部执行器12使所有的钉同时成形。其余“被压溃的”主体材料31用作止血剂(ORC)和钉线增强剂(PGA、PDS或任何上述其他膜组合物38)。此外，由于钉32在成形期间不必离开仓体31，因此钉32在成形期间变为畸形的可能性被最小化。如本文所用，术语“植入式”是指除钉之外，支撑钉的仓体材料也将被保持在患者体内并可最终被患者身体吸收。此类植入式钉仓区别于先前的钉仓结构，该先前的钉仓构造在其已被击发之后仍然完整地定位在端部执行器内。
在各种具体实施中，端部执行器12能够联接到自柄部组件100突起的细长轴组件40。端部执行器12(在闭合时)和细长轴组件40可具有相似的横截面形状，并且其尺寸被设定成以另一种进入器械形式操作地穿过套管针管或工作通道。如本文所用，术语“可操作地穿过”是指端部执行器和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。当处于闭合位置时，端部执行器12的钳口13和15可为端部执行器提供大体圆形的横截面形状以利于其穿过圆形的通路/开口。然而，可设想本发明的端部执行器以及细长轴组件设有其他横截面形状，从而可以其他方式穿过具有非圆形横截面形状的进入通路和开口。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打算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，这是指其能够可操作地穿过直径至少为大约5mm的开口。
细长轴组件40可具有与处于闭合位置的端部执行器12的外径基本相等的外径。例如，5mm端部执行器可联接到具有5mm横截面直径的细长轴组件40。然而，继续参阅本具体实施方式，将显而易见的是，本发明可有效地结合不同尺寸的端部执行器使用。例如，10mm端部执行器可附接到具有5mm横截面直径的细长轴。相反，对于其中提供10mm或更大的进入开口或通道的应用而言，细长轴组件40可具有10mm(或更大)的横截面直径，但也能够致动5mm或10mm端部执行器。因此，外轴40的外径可与附接到其上的闭合的端部执行器12的外径相同或不同。
如图所示，细长轴组件40从柄部组件100大体上沿着直线向远侧延伸，以限定纵向轴线A-A。例如，细长轴组件40可为约9-16英寸(229-406mm)长。然而，细长轴组件40可设置为其他长度，或者可在其中具有接头或以其他方式能够有利于端部执行器12相对于轴或柄部组件的其他部分进行关节运动，如下文将更详细地论述。细长轴组件40包括脊构件50，该脊构件从柄部组件100延伸到端部执行器12。端部执行器12的细长通道14的近侧末端具有从其突起的一对保持凸耳17，该对保持凸耳的尺寸被设定成接收在脊构件50的远侧末端中所提供的对应的凸耳开口或支架52中，以使端部执行器12能够可移除地联接细长轴组件40。脊构件50可由例如6061或7075铝、不锈钢、钛等制成。
柄部组件100包括手枪抓握型外壳，该手枪抓握型外壳可出于组装目的而被制成两个或更多个部分。例如，如图所示的柄部组件100包括由聚合物或塑性材料模塑或换句话讲制成的、并被设计成配合在一起的右手壳体构件102和左手壳体构件(未示出)。可通过在其中模塑的或换句话讲形成的按扣特征结构、栓、和承窝、和/或通过粘合剂、螺钉等而将此类壳体构件附接到一起。脊构件50具有近侧末端54，在该近侧末端上形成有凸缘56。凸缘56能够可旋转地支撑在沟槽106中，该沟槽由从壳体构件102,104中的每一个向内突起的配合肋108形成。此类构造有利于脊构件50附接到柄部组件100，同时使脊构件50能够相对于柄部组件100沿360°路径围绕纵向轴线A-A旋转。
如在图1中可进一步看出，脊构件50穿过安装轴衬60并由安装轴衬60支撑，该安装轴衬60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，其限定旋转沟槽65，该旋转沟槽能够将柄部组件100的前缘部分101可旋转地接收在其间。这种构造使安装轴衬60能够相对于柄部组件100围绕纵向轴线A-A旋转。脊构件50通过脊销66不可旋转地销接至安装轴衬60。另外，旋钮70附接到安装轴衬60。例如，旋钮70具有中空安装凸缘部72，该中空安装凸缘部的尺寸被设定成将安装轴衬60的一部分接收在其中。旋钮70可由例如玻璃或碳填充尼龙、聚碳酸酯、等制成，并且也通过脊销66附连到安装轴衬60。此外，向内突起的保持凸缘74形成在安装凸缘部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钮70并使其相对于柄部组件100旋转，而使脊构件50(和附接到其上的端部执行器12)围绕纵向轴线A-A沿360°路径旋转。
砧座20由砧座弹簧21和/或另一个偏置构造保持在打开位置。通过大体被标记为109的击发系统，砧座20可从打开位置选择性地运动到各种闭合或夹紧位置以及击发位置。击发系统109包括“击发构件”110，其包括中空击发管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可由聚合物或其他合适的材料制成，并具有附接到击发系统109的击发轭114的近侧末端。例如，击发轭114可模压到击发管110的近侧末端。然而，也可采用其他紧固件构造。
如在图1中可看出，击发轭114能够可旋转地支撑在支撑衬圈120中，该支撑衬圈能够在柄部组件100中轴向运动。支撑衬圈120具有一对侧向延伸的翅片，该对翅片的尺寸设定成可滑动地接收在形成于左手壳体构件和右手壳体构件中的翅片狭槽内。因此，支撑衬圈120可在柄部外壳100中轴向滑动，同时使击发轭114和击发管110能够相对于支撑衬圈120围绕纵向轴线A-A旋转。根据本发明，穿过击发管110设置有纵向狭槽，以使脊销66能够穿过其中延伸到脊构件50中，同时有利于击发管110在脊构件50上轴向行进。
击发系统109还包括击发触发器130，该击发触发器用于控制击发管110在脊构件50上的轴向行进。参见图1。沿着击发管110的远侧方向形成与砧座20击发交互的此类轴向运动在本文中称为“击发动作”。如在图1中可看出，击发触发器130通过枢轴销132可运动地或者可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中可看出，击发触发器130具有上部134，该上部可运动地附接(销接)到击发链节136，该击发链节可运动地附接(销接)到支撑衬圈120。因此，击发触发器130从起始位置(图1)朝邻近柄部组件100的手枪式握把部107的终止位置的运动将导致击发轭114和击发管110沿着远侧方向“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的偏置力下)将导致击发轭114和击发管110在脊构件50上沿着近侧方向“PD”运动。
本发明可与不同尺寸和构型的植入式钉仓一起使用。例如，当结合第一击发衔接子140使用时，外科器械10可与支撑植入式钉仓30的约20mm长(或以其他长度)的5mm端部执行器12一起使用。这种端部执行器尺寸可尤其非常适用于例如实现相对精细的解剖及血管处理。然而，如下文所更详细所述，例如也可通过将第一击发衔接子140更换为第二击发衔接子而将外科器械10与其他尺寸的端部执行器和钉仓结合使用。作为另外的替代形式，细长轴组件40能够附接到仅一种形式或尺寸的端部执行器。
现在将阐释一种将端部执行器12可移除地联接到脊构件50的方法。通过将细长通道14上的保持凸耳17插入脊构件50中的凸耳支架52中来开始联接过程。随后，外科医生将击发触发器130朝向外壳组件100的手枪式握把107推进，以将击发管110和第一击发衔接子140向远侧推进到细长通道14的近侧末端部分47之上，从而将凸耳17保持在其各自的支架52中。第一击发衔接子140在凸耳17上的这种位置在本文中称为“联接位置”。本发明还可具有端部执行器锁定组件以用于在端部执行器12已附接到脊构件50之后将击发触发器130锁定在适当位置。
更具体地讲，端部执行器锁定组件160的一个实施例包括保持销162，该保持销被可运动地支撑在击发触发器130的上部134中。如上所述，击发管110必须首先向远侧被推进至联接位置，其中第一击发衔接子140将端部执行器12的保持凸耳17保持在脊构件50中的凸耳支架52中。外科医生通过从起始位置朝手枪式握把107牵拉击发触发器130而将击发衔接子140向远侧推进到联接位置。当击发触发器130被首先致动时，保持销162向远侧运动，直到击发管110将第一击发衔接子140推进到联接位置，此时保持销162被偏置到形成于壳体构件中的锁定腔164中。任选地，当保持销162进入锁定腔164中时，销162可发出可听见的“咔嗒”声或其他声音，而且为外科医生提供端部执行器12已被“锁定”到脊构件50上的触觉指示。另外，只要不有意地将保持销162偏置出锁定腔164，外科医生便不会无意间继续致动击发触发器130以开始使端部执行器12中的钉32成形。相似地，如果外科医生释放处于联接位置的击发触发器130，则保持销162会使击发触发器130保持在该位置，以防止击发触发器130返回至起始位置并因此从脊构件50释放端部执行器12。
本发明还可包括击发系统锁定按钮137，该击发系统锁定按钮以能够枢转的方式附接到柄部组件100。在一种形式中，击发系统锁定按钮137具有在其远侧末端上形成的闩锁138，该闩锁被取向成当击发释放按钮处于第一闩锁位置时接合击发轭114。如在图1中可看出，闩锁弹簧139用于将击发系统锁定按钮137偏置到第一闩锁位置。在各种情况下，闩锁138用于在以下点处接合击发轭114：在该点处，脊构件50上的击发轭114的位置对应于其中第一击发衔接子140即将朝远侧推进到砧座20上的夹紧滑道28上的点。应当理解，随着第一击发衔接子140轴向地向夹紧滑道28上推进，砧座20将沿路径运动，使得钉成形表面部分22基本上平行于钉仓30的顶部表面36。
在端部执行器12联接到脊构件50之后，通过首先压下击发系统锁定按钮137而开始钉成形过程，以使击发轭114能够在脊构件50上进一步向远侧运动并最终将砧座20压缩到钉仓30中。在压下击发系统锁定按钮137之后，外科医生继续朝手枪式握把107致动击发触发器130，从而将第一钉衬圈140的驱动到对应的钉成形滑道29上，以迫使砧座20与钉仓30中的钉32成形接触。击发系统锁定按钮137防止在外科医生准备好开始该过程之前无意地使钉32成形。在该实施例中，外科医生必须在击发触发器130可被进一步致动之前压下击发系统锁定按钮137以开始钉成形过程。
外科器械10可视需要而仅用作组织缝合装置。然而，本发明也可包括组织切割系统，该组织切割系统大体被标记为170。在至少一种形式中，组织切割系统170包括刀构件172，可通过致动刀行进触发器200将该刀构件选择性地从邻近侧末端部执行器12的近侧末端的未致动位置推进到致动位置。刀构件172被可运动地支撑在脊构件50内，并附接到刀杆180或换句话讲从刀杆180突起。刀构件172可由例如具有大于38HRC(洛氏硬度C级)的硬度的420或440不锈钢制成，并可具有形成于其远侧末端174上的组织切割刃176，并能够可滑动地延伸穿过砧座20中的狭槽以及在钉仓30中居中设置的狭槽33，以切穿夹紧于端部执行器12中的组织。刀杆180延伸穿过脊构件50并且具有与刀传送装置传动交接的近侧末端部分，该刀传送装置可操作地附接到刀行进触发器200。刀行进触发器200附接到枢轴销132，使得其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。根据本发明，第一刀齿轮192也附接到枢轴销132，使得刀行进触发器200的致动也使第一刀齿轮192枢转。第一刀齿轮192与柄部壳体100之间附接有击发返回弹簧202，以将刀行进触发器200偏置到起始位置或未致动位置。
刀传送装置还包括第二刀齿轮194，该第二刀齿轮可旋转地支撑在第二齿轮轴上并与第一刀齿轮192啮合。第二刀齿轮194与支撑在第三齿轮轴上的第三刀齿轮196啮合。第四刀齿轮198也被支撑在第三齿轮轴195上。第四刀齿轮198能够传动接合在刀杆180的近侧末端上的一系列环形齿轮齿或环。因此，这种构造使第四刀齿轮198能够沿远侧方向“DD”或近侧方向“PD”轴向地驱动刀杆180，同时使击发杆180相对于第四刀齿轮198围绕纵向轴线A-A旋转。因此，外科医生可通过朝柄部组件100的手枪式握把107牵拉刀行进触发器200而使击发杆180轴向地推进并最终朝远侧推动刀构件172。
本发明还包括刀锁定系统210，该刀锁定系统防止刀构件172的推进，除非击发触发器130已被牵拉至完全击发位置。因此，这种结构将防止刀推进系统170的激活，除非钉已首先被击发或成形于组织中。如在图1中可看出，刀锁定系统210的各种具体实施包括刀锁定杆211，该刀锁定杆以能够枢转的方式支撑在柄部组件100的手枪式握把部107中。刀锁定杆211具有激活端212，当击发触发器130处于完全击发位置时，激活端212能够被击发触发器130接合。另外，刀锁定杆211在其另一端上具有保持吊钩214，该保持吊钩能够以吊钩方式接合第一切割齿轮192上的闩锁杆216。采用刀锁定弹簧218来将刀锁定杆211偏置到“锁定”位置，其中保持吊钩214保持与闩锁杆216接合，从而防止刀行进触发器200的致动，除非击发触发器130处于完全击发位置。
在钉被“击发”(成形)至靶组织中之后，外科医生可压下击发触发器释放按钮167，以使击发触发器130能够在扭转弹簧135的偏置下返回至起始位置，从而使砧座20能够在弹簧21的偏置下偏置到打开位置。当处于打开位置时，外科医生可撤出端部执行器12而留下植入式钉仓30和钉32。在其中端部执行器穿过通道、工作通道等而被插入的应用中，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能够通过通道或工作通道被撤出。然而，如果外科医生想要在击发钉之后切割靶组织，则外科医生以上述方式激活刀行进触发器200，以驱动刀杆172穿过靶组织到达端部执行器的端部。随后，外科医生可释放刀行进触发器200，以使击发返回弹簧202能够使击发传送装置将刀杆172返回至起始(未致动)位置。一旦刀杆172返回至起始位置，外科医生便可打开端部执行器钳口13、15，以将植入式仓30释放于患者体内并随后从患者体内撤出端部执行器12。因此，此类外科器械有利于使用可通过相对较小的工作通道和通道而被插入的小的植入式钉仓，同时为外科医生提供如下选择：在不切割组织的情况下击发钉、或视需要在击发钉之后还切割组织。
本发明的各种独特和新型实施例采用可压缩的钉仓，所述可压缩的钉仓支撑处于基本上固定位置以用于被砧座成形接触的钉。将砧座驱动到未成形钉中，其中例如所达到的钉成形的程度取决于砧座被驱动到钉中多远。此类构造使得外科医生能够调节施加至钉的成形或击发压力的量，从而改变钉的最终成形高度。在本发明的其他实施例中，外科缝合构造可采用钉驱动元件，该钉驱动元件可将钉朝向砧座抬起。下文对这些实施例进行了更详细的描述。
任选地，参照上文，施加到可移动砧座的击发动作的量取决于击发触发器的致动的程度。例如，如果外科医生想要获得仅部分成形的钉，则仅需朝手枪式握把107部分地向内压下击发触发器。要获得更多的钉成形，外科医生仅需进一步压紧击发触发器，使得砧座被进一步驱动以与钉进行成形接触。如本文所用，术语“成形接触”是指钉成形表面或钉成形凹坑已接触钉腿的端部并已开始将腿成形或弯曲至成形位置。钉成形的程度是指钉腿被折叠的程度且最终是指上文所提及的钉的成形高度。本领域中的普通技术人员将进一步理解，因为在对砧座20施加击发动作时，砧座20是以与钉仓基本上平行的关系进行运动，所以钉基本上同时成形并具有基本上相同的成形高度。
图2和图3示出了可供选择的端部执行器12”，除以下能够容纳刀杆172’的不同点之外，端部执行器12”类似于上述端部执行器12’。刀杆172’联接到刀杆180或自刀杆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，在该实施例中，刀杆172’足够长以横贯端部执行器12”的整个长度，因此端部执行器12”中未采用单独的远侧刀构件。刀杆172’上形成有上横向构件173’和下横向构件175’。上横向构件173’被取向成滑动地横贯砧座20”中的对应细长狭槽250，并且下横向构件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。脱离狭槽(未示出)也设置在砧座20”中，使得当刀杆172’已被驱动到端部执行器12”内的终止位置时，上横向构件173’下降穿过对应的狭槽以允许砧座20”运动到打开位置以脱离缝合和切割的组织。砧座20”可除此之外与上述砧座20相同，并且细长通道14”可除此之外与上述细长通道14相同。
在这些实施例中，砧座20”被弹簧或其他打开构造(未示出)偏置到完全打开位置(图2)。砧座20”通过击发衔接子150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3)，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，以允许砧座20”远离细长通道14”运动，如图4中的虚线所示。在该实施例中，随着刀杆172”朝远侧运动，上横向构件173’和下横向构件175’一起拉动砧座20”和细长通道14”，以在刀杆172”穿过端部执行器12”朝远侧推进时实现期望的钉成形。参见图5。因此，在该实施例中，钉成形是与组织切割同时发生，但钉本身可在刀杆172”朝远侧驱动时依序成形。
本发明的各种外科钉仓及外科器械的独特且新型的结构使所述钉仓中的钉能够布置成一条或多条线性或非线性的线。细长狭槽的每个侧上可设有多条这种钉线，所述细长狭槽居中地设置在钉仓内，以用于容纳穿过其中的组织切割构件。在一种构造中，例如成一条线的钉可大体上平行于在钉的相邻线中的钉但与其偏离。作为另外的替代形式，一条或多条钉线可本质上为非线性的。也就是说，钉线中的至少一个钉的基部可沿基本上与同一钉线中的其他钉的基部横切的轴线延伸。例如，细长狭槽每侧的钉线可具有锯齿形外观。
根据本发明，钉仓可包括仓体和储存在仓体内的多个钉。在使用中，可将钉仓引入手术部位中并将其定位在所处理的组织的侧面。另外，可将钉成形砧座定位在组织的相对侧上。砧座可由第一钳口携载并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，则可从钉仓体中射出钉，使得钉可刺穿组织并接触钉成形砧座。一旦从钉仓体中部署钉，则然后可从手术部位移除钉仓体。钉仓或钉仓的至少一部分中可植入有钉。例如，如下文所更详细地描述，钉仓可包括仓体，当砧座从打开位置运动到闭合位置时，该仓体可被砧座压缩、压碎和/或塌缩。当仓体被压缩、压溃和/或塌缩时，定位在仓体中的钉可通过砧座而变形。作为另外一种选择，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，当钉至少部分地定位在仓体内时，钉可变形。在一些情况下，钉可不从钉仓射出，而在其他情况下，钉可随同仓体的一部分一起从钉仓射出。
现在参见图6A-图6D，可压缩钉仓(诸如钉仓1000)例如可包括可压缩、植入式仓体1010，以及此外定位在可压缩仓体1010中的多个钉1020，但图6A-图6D仅示出一个钉1020。图6A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被示为处于未压缩条件。在这种未压缩条件中，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6B所示，以及将组织T抵靠仓体1010定位。即使砧座1040可将组织T定位成抵靠钉仓体1010的组织接触表面1019，然而再次参见图6B，钉仓体1010此时可经受极少的(如果有的话)压缩力或压力，并且钉1020可保持在未成形或未击发条件。如图6A和图6B所示，钉仓体1010可包括一个或多个层，并且钉1020的钉腿1021可穿过这些层向上延伸。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中间，其中第三层1013可定位在第二层1012与第四层1014中间。例如，钉1020的基部1022可定位在第四层1014中的腔体1015中，并且钉腿1021可从基部1022向上延伸并且穿过第四层1014、第三层1013和第二层1012。任选地，每个可变形腿1021可包括顶端，诸如锋利的顶端1023，例如当钉仓1000处于未压缩条件时，该锋利的顶端可定位在第二层1012中。例如，顶端1023可不延伸至和/或穿过第一层1011，其中当钉仓1000处于未压缩条件时，顶端1023可不突起穿过组织接触表面1019。当钉仓处于未压缩条件时，锋利的顶端1023可定位在第三层1013和/或任何其他合适的层中。作为另外一种选择，钉仓的仓体可具有任何合适的层数目，例如少于四层或多于四层。
任选地，如下文所更详细地描述，第一层1011可由支撑物材料和/或塑性材料(例如，聚二氧杂环己酮(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/或可压缩止血材料(例如，氧化再生纤维素(ORC))构成。任选地，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钉1020保持在钉仓体1010中，并且另外可使钉1020保持相互对齐。第三层1013可由支撑物材料或相当不可压缩的或非弹性材料构成，该材料能够将钉1020的钉腿1021相对于彼此保持在适当位置。此外，定位在第三层1013的相对侧上的第二层1012和第四层1014可稳定或减少钉1020的运动，即使第二层1012和第四层1014可由可压缩的泡沫或弹性材料构成。钉腿1021的钉顶端1023可至少部分地嵌入第一层1011中。例如，第一层1011和第三层1013能够可协作地并且稳固地将钉腿1021保持在适当位置。第一层1011和第三层1013可分别由例如可生物吸收材料(诸如以商品名Vicryl出售的聚乙醇酸(PGA)、聚乳酸(PLA或PLLA)、聚二氧杂环己酮(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)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止血剂构成。
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的大约两倍、大约三倍、大约四倍、大约五倍和/或大约十倍。换句话讲，针对给定的力，第二层1012的压缩程度可为第一层1011的大约两倍、大约三倍、大约四倍、大约五倍、和/或大约十倍。第二层1012的可压缩性例如可在第一层1011的大约两倍与大约十倍之间。第二层1012可包括限定于其中的多个气隙，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的期望可压缩性。与上文相似，尽管第三层1013可为可压缩的，然而第四层1014能够比第三层1013基本上更具可压缩性。例如，第四层1014的可压缩性可为第三层1013的大约两倍、大约三倍、大约四倍、大约五倍、和/或大约十倍。换句话讲，针对给定的力，第四层1014的压缩程度可为第三层1013的大约两倍、大约三倍、大约四倍、大约五倍、和/或大约十倍。第四层1014的可压缩性可在第三层1013的大约两倍与大约十倍之间。第四层1014可包括限定于其中的多个气隙，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的期望可压缩性。在各种情况下，可通过压缩率(即，层针对给定大小的力所压缩的距离)来表达仓体或仓体层的可压缩性。例如，与具有较低压缩率的层相比，具有高压缩率的层针对施加至该层的给定大小的压缩力将压缩更大的距离。如此而言，第二层1012可比第一层1011具有更高的压缩率；相似地，第四层1014可比第三层1013具有更高的压缩率。第二层1012和第四层1014可由相同的材料构成并且可具有相同的压缩率。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且可具有相同的压缩率。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6C所示。在这种情况下，砧座1040可朝钉仓支撑件1030向下推动仓体1010的顶部表面或组织接触表面1019。钉仓支撑件1030可包括仓支撑表面1031，其能够在钉仓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可被压缩并且砧座1040可接触钉1020。更具体地讲，仓体1010的压缩和组织接触表面1019的向下运动可使钉腿1021的顶端1023刺穿仓体1010的第一层1011、刺穿组织T并且进入砧座1040中的成形凹坑1042中。当仓体1010被砧座1040进一步压缩时，顶端1023可接触限定成形凹坑1042的壁，并且例如因此腿1021可向内变形或卷曲，如图6C所示。当钉腿1021被变形时，同样如图6C所示，钉1020的基部1022可接触钉仓支撑件1030或由钉仓支撑件1030支撑。任选地，如下文更详细地描述，钉仓支撑件1030可包括多个支撑结构，诸如例如钉支撑沟槽、狭槽或槽1032，所述多个支撑结构能够在钉1020被变形时支撑钉1020或至少钉1020的基部1022。同样如图6C所示，施加至钉仓体1010的压缩力可使第四层1014中的腔体1015塌缩。除腔体1015之外，钉仓体1010还可包括一个或多个空隙(诸如空隙1016)，例如所述一个或多个空隙中可包括或不包括定位在其中的钉的一部分，所述一个或多个空隙能够允许仓体1010塌缩。腔体1015和/或空隙1016能够塌缩，使得限定腔体和/或壁的壁向下偏转并接触仓支撑表面1031和/或接触仓体1010的定位于腔体和/或空隙下方的层。
在比较图6B和图6C时，显然，第二层1012及第四层1014被砧座1040所施加的压缩压力基本上压缩。也可注意，第一层1011和第三层1013也被压缩。当砧座1040运动至其闭合位置时，砧座1040可通过朝钉仓支撑件1030向下推动组织接触表面1019而继续进一步压缩仓体1010。当仓体1010被进一步压缩时，砧座1040可使钉1020变形至其完全成形形状，如图6D所示。参见图6D，每个钉1020的腿1021可朝每个钉1020的基部1022向下变形，以便将组织T、第一层1011、第二层1012、第三层1013和第四层1014的至少一部分捕获在可变形腿1021与基部1022之间。在比较图6C和图6D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6C和图6D时也可注意，第一层1011和第三层1013也被进一步压缩。在钉1020被完全或至少充分地成形之后，砧座1040可远离组织T而被抬起，并且钉仓支撑件1030可远离和/或脱离钉仓1000运动。如图6D所示并由于上文所述，仓体1010可植入有钉1020。在各种实施例中，被植入的仓体1010可沿钉线支撑组织。在一些情况下，植入的仓体1010中包含的止血剂和/或任何其他适合的治疗药物可随着时间推移来处理组织。如上所述的止血剂可减少缝合和/或切割的组织出血，同时键合剂或组织粘合剂可随着时间推移为组织提供强度。所植入的仓体1010可由诸如ORC(氧化再生纤维素)、细胞外蛋白(诸如胶原)、以商品名Vicryl出售的聚乙醇酸(PGA)、聚乳酸(PLA或PLLA)、聚二氧杂环己酮(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的复合物的材料构成。在某些情况下，仓体1010可包括例如能够减小手术部位感染的可能性的抗生和/或抗菌材料，诸如胶体银和/或三氯生。
仓体1010的层可相互连接。例如，可利用至少一种粘合剂(诸如血纤维蛋白和/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，并且将第四层1014粘附至第三层1013。尽管未示出，但仓体1010的层可通过联锁机械特征结构连接在一起。例如，第一层1011和第二层1012可各自包括相对应的联锁特征结构，诸如榫槽结构和/或燕尾榫结构。相似地，第二层1012和第三层1013可各自包括相对应的联锁特征结构，同时第三层1013和第四层1014可各自包括相对应的联锁特征结构。尽管未示出，但钉仓1000可包括例如一个或多个铆钉，该一个或多个铆钉可延伸穿过仓体1010的一个或多个层。例如，每个铆钉可包括邻近第一层1011定位的第一末端或头部以及邻近第四层1014而定位的第二头部，该第四层可被组装到铆钉的第二末端或由铆钉的第二末端形成。例如，由于仓体1010的可压缩性质，铆钉可压缩仓体1010，使得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。例如，铆钉可由可生物吸收的材料(诸如以商品名Vicryl出售的聚乙醇酸(PGA)、聚乳酸(PLA或PLLA)、聚二氧杂环己酮(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。除通过仓体1010中所容纳的钉1020之外，仓体1010的层可不彼此连接。例如，钉腿1021与仓体1010之间的摩擦接合例如可将仓体1010的层保持在一起，并且一旦钉成形，则所述层可被捕获在钉1020中。钉腿1021的至少一部分可包括可以增大钉1020与仓体1010之间的摩擦力的粗糙化表面或粗糙涂层。
如上所述，外科器械可包括第一钳口及第二钳口，第一钳口包括钉仓支撑件1030，第二钳口包括砧座1040。任选地，如下文所更详细描述，钉仓1000可包括一个或多个保持结构，该一个或多个保持结构能够接合钉仓支撑件1030并且因此将钉仓1000可释放地保持到钉仓支撑件1030。例如，可通过至少一种粘合剂(诸如，血纤维蛋白和/或蛋白水凝胶)将钉仓1000粘附到钉仓支撑件1030。在使用中，在至少一种情况下，尤其是在腹腔镜式和/或内窥镜式手术中，第二钳口可运动至与第一钳口相对的闭合位置，例如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。例如，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其而被插入。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，该部分闭合位置可允许第一钳口和第二钳口穿过套管针被插入，而无需使钉仓体1010中所容纳的钉1020变形。例如，当第二钳口处于其部分闭合的中间位置时，砧座1040可不对钉仓体1010施加压缩力，但当第二钳口处于其部分闭合的中间位置时，砧座1040可压缩钉仓体1010。尽管当砧座1040处于这种中间位置时可压缩钉仓体1010，然而砧座1040可不完全地压缩钉仓体1010，使得砧座1040接触钉1020和/或使得钉1020被砧座1040变形。一旦第一钳口和第二钳口通过套管针而被插入手术部位中，则第二钳口可被再次打开，并且砧座1040及钉仓1000可如上所述相对于靶组织进行定位。
现在参见图7A-图7D，外科缝合器的端部执行器可包括定位于砧座1140与钉仓支撑件1130中间的植入式钉仓1100。与上文相似，砧座1140可包括组织接触表面1141，钉仓1100可包括组织接触表面1119，并且钉仓支撑件1130可包括能够支撑钉仓1100的支撑表面1131。参见图7A，可利用砧座1140将组织T定位成抵靠钉仓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，当砧座1140朝钉仓支撑件1130运动时，现在参见图7B，砧座1140可向下推动钉仓1100的顶部表面或组织接触表面1119并压缩仓体1110的第一层1111和第二层1112。随着层1111和层1112被压缩，再次参见图7B，第二层1112可被压溃，并且钉1120的腿1121可刺穿第一层1111并进入到组织T中。例如，钉1120可至少部分地定位在第二层1112中的钉腔或空隙1115中，并且当第二层1112被压缩时，钉腔1115可塌缩并因此允许第二层1112围绕钉1120塌缩。第二层1112可包括盖部分1116，该盖部分可延伸于钉腔1115之上并包围或至少部分地包围钉腔1115。图7B示出了被向下压溃至钉腔1115中的覆盖部1116。第二层1112可包括一个或多个弱化部分，其可有利于第二层1112的塌缩。任选地，此类弱化部分可包括例如能够有利于仓体1110的可控塌缩的划痕、穿孔和/或薄的横截面。第一层1111可包括能够有利于钉腿1121穿透第一层1111的一个或多个弱化部分。任选地，此类弱化部分可包括例如能够与钉腿1121对齐或至少基本上对齐的划痕、穿孔和/或薄的横截面。
再次参见图7A，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7B，组织接触表面1141与仓支撑表面1131之间的距离可由短于距离1101a的距离1101b限定。在各种情况下，砧座1140的组织接触表面1141与仓支撑表面1131之间的由距离1101b限定的间隙可大于原始的未变形的钉仓高度1102a。现在参见图7C，当砧座1140运动至更靠近仓支撑表面1131时，第二层1112可继续塌缩并且钉腿1121与成形凹坑1142之间的距离可减小。相似地，组织接触表面1141与仓支撑表面1131之间的距离可减小到距离1101c，该距离可大于、等于或小于原始的未变形仓高度1102a。现在参见图7D，砧座1140可运动至最终的击发位置，其中钉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7D所示，钉腔1115可完全或至少基本上塌缩，并且钉1120可完全或至少基本上被塌缩的第二层1112围绕。在各种情况下，砧座1140可随后远离钉仓1100运动。例如，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，相邻的钉1120之间的位置)中。压溃的仓体1110可能并不回弹性地再次扩展。成形的钉1120和另外定位在相邻的钉1120之间的仓体1110可对组织T施加压力或压缩力，这可提供各种治疗益处。
如上所述，再次参见图7A，每个钉1120可包括自其延伸的钉腿1121。例如，尽管钉1120被绘示为包括两个钉腿1121，然而也可利用可包括一个钉腿或作为另外一种选择包括超过两个钉腿(诸如三个钉腿或四个钉腿)的各种钉。如图7A所示，每个钉腿1121均可嵌入仓体1110的第二层1112中，使得钉1120固定于第二层1112中。钉1120可被插入仓体1110中的钉腔1115中，使得钉腿1121的顶端1123在基部1122之前进入腔体1115中。在顶端1123被插入腔体1115之后，顶端1123可被按压到盖部分1116中并切割第二层1112。钉1120可被坐置到第二层1112中的足够深度处，使得钉1120相对于第二层1112不运动或至少基本上不运动。钉1120可被坐置到第二层1112中的足够深度处，使得基部1122被定位或嵌入钉腔1115中。作为另外一种选择，基部1122可不被定位或嵌入第二层1112中。再次参见图7A，基部1122可在仓体1110的底部表面1118下方延伸。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。仓支撑表面1130可包括从其延伸和/或限定于其中的支撑结构，例如，钉1120的基部1122可被定位在例如钉仓支撑件1130中的一个或多个支撑沟槽、狭槽或槽1132中或由该一个或多个支撑沟槽、狭槽或槽1132支撑，如下文将更详细地描述。
现在参见图8和图9，钉仓(诸如钉仓1200)例如可包括可压缩的植入式仓体1210，该仓体包括外层1211和内层1212。与上文相似，钉仓1200可包括定位在仓体1210内的多个钉1220。任选地，每个钉1220均可包括基部1222以及从其延伸的一个或多个钉腿1221。例如，钉腿1221可插入内层1212中并被坐置到例如使钉1220的基部1222邻接和/或邻近内层1212的底部表面1218定位的深度。在图8和图9中，内层1212不包括能够接收钉1220的一部分的钉腔，而作为另外一种选择，内层1212可包括此类钉腔。对上文进行进一步描述，内层1212可由能够允许仓体1210在对其施加压缩负载时塌缩的可压缩材料(诸如可生物吸收的泡沫和/或氧化再生纤维素(ORC))构成。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商购获得并且可包括松散的织造织物(像外科海绵一样)、松散的纤维(像棉球一样)和/或泡沫。内层1212可由其中包含和/或上面涂覆有药物(诸如冷冻干燥的凝血酶和/或血纤维蛋白)的材料构成，该药物例如可被患者体内的流体水活化和/或活化。例如，冷冻干燥的凝血酶和/或血纤维蛋白可保持在例如Vicryl(PGA)基质上。然而，在某些情况下，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8和图9，外层1211可由不透水的或至少基本上不透水的材料构成，使得液体不接触或至少基本上不接触内层1212，直到仓体1210已被压缩并且钉腿已穿透外层1211之后和/或外层1211已被以一些方式切割之后。例如，外层1211可由支撑物材料和/或塑性材料(诸如聚二氧杂环己酮(PDS)和/或聚乙醇酸(PGA))构成。外层1211可包括环绕内层1212和钉1220的包裹物。更具体地讲，钉1220可被插入内层1212和外层1211中并围绕包括内层1212和钉1220的子组件而被包裹并随后被密封。
如本文所述，当砧座运动到闭合位置时，钉仓的钉可由砧座完全成形。作为另外一种选择，现在参见图10-图13，诸如钉仓4100的钉仓的钉例如可通过当砧座运动到闭合位置时的砧座，以及另外通过使钉朝闭合的砧座运动的钉驱动器系统而变形。钉仓4100可包括可压缩的仓体4110，该可压缩的仓体可例如由泡沫材料以及至少部分地定位在可压缩仓体4110内的多个钉4120构成。钉驱动器系统可包括驱动器夹持器4160、定位在驱动器夹持器4160内的多个钉驱动器4162、以及钉仓盘4180，该钉仓盘能够将钉驱动器4162保持在驱动器夹持器4160中。例如，钉驱动器4162可定位在驱动器夹持器4160中的一个或多个狭槽4163内，其中狭槽4163的侧壁可帮助朝砧座向上引导钉驱动器4162。钉4120可由钉驱动器4162支撑在狭槽4163内，其中当钉4120和钉驱动器4162处于其未击发位置时，钉4120可完全定位在狭槽4163中。作为另外一种选择，当钉4120和钉驱动器4162处于其未击发位置时，钉4120的至少一部分可穿过狭槽4163的开口端4161向上延伸。例如，现在主要参见图11，钉4120的基部可被定位在驱动器夹持器4160内，并且钉4120的顶端可嵌入可压缩仓体4110内。钉4120的大约三分之一的高度可定位在驱动器夹持器4160内，并且钉4120的大约三分之二的高度可定位在仓体4110内。参见图10A，例如钉仓4100还可包括围绕仓体4110和驱动器夹持器4160的水不可渗透的包裹物或膜4111。
在使用中，例如，钉仓4100可定位在钉仓通道内，并且砧座可朝钉仓4100运动到闭合位置。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。当砧座处于其闭合位置时，砧座可不接触钉4120。当砧座运动至其闭合位置时，砧座可接触钉4120的腿并且至少部分地使钉4120变形。在任一情形中，钉仓4100还可包括一个或多个滑动件4170，所述一个或多个滑动件可在钉仓4100沿纵向推进，使得滑动件4170可随后接合钉驱动器4162并且使钉驱动器4162和钉4120朝砧座运动。滑动件4170可在钉仓盘4180与钉驱动器4162之间滑动。在砧座的闭合已使钉4120的成形过程开始的情况下，钉4120朝砧座向上运动可完成成形过程并使钉4120变形至其完全成形的高度或至少期望的高度。在砧座的闭合未使钉4120变形的情况下，钉4120朝砧座向上运动可开始并完成成形过程并且使钉4120变形至其完全成形的高度或至少期望的高度。滑动件4170可从钉仓4100的近侧末端推进到钉仓4100的远侧末端，使得在定位于钉仓4100的远侧末端中的钉4120完全成形之前，定位于钉仓4100的近侧末端中的钉4120完全成形。参见图12，滑动件4170可各自包括至少一个成角度的或倾斜的表面4711，其能够在钉驱动器4162下方滑动并如图13所示提升钉驱动器4162。
对上文进行进一步描述，钉4120可被成形，以便将组织T的至少一部分和钉仓4100的可压缩仓体4110的至少一部分捕获在其中。在钉4120成形之后，外科缝合器的砧座和钉仓通道4130可远离已植入的钉仓4100运动。在各种情况下，仓盘4180可以固定地接合钉仓通道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可与可压缩的仓体4110分离。再次参见图10，仓盘4180可包括相对的侧壁4181，仓体4110能够可移除地定位在该相对的侧壁4181之间。例如，可压缩仓体4110可被压缩于侧壁4181之间，使得在使用期间仓体4110能够可移除地保持在其间，并且当仓盘4180被拉离时，仓体4110从仓盘4180可释放地脱离。例如，驱动器夹持器4160可连接到仓盘4180，使得当仓盘4180从手术部位移除时，驱动器保持器4160、驱动器4162和/或滑动件4170可保持在仓盘4180中。驱动器4162可从驱动器夹持器4160射出并且留在手术部位中。例如，驱动器4162可由可生物吸收的材料(诸如以商品名Vicryl出售的聚乙醇酸(PGA)、聚乳酸(PLA或PLLA)、聚二氧杂环己酮(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。驱动器4162可附接到钉4120，使得驱动器4162部署有钉4120。例如，每个驱动器4162可包括例如能够接收钉4120的基部的槽，其中所述槽能够以压力配合方式和/或搭扣配合方式接收钉基部。
对上文进行进一步描述，驱动器夹持器4160和/或滑动件4170可从仓盘4180射出。例如，滑动件4170可在仓盘4180与驱动器夹持器4160之间滑动，使得当滑动件4170推进以向上驱动钉驱动器4162和钉4120时，滑动件4170也可使驱动器夹持器4160向上运动到仓盘4180之外。例如，驱动器夹持器4160和/或滑动件4170可由可生物吸收的材料(诸如以商品名Vicryl出售的聚乙醇酸(PGA)、聚乳酸(PLA或PLLA)、聚二氧杂环己酮(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。滑动件4170可整体地形成和/或附接到驱动棒或切割构件，所述驱动棒或切割构件穿过钉仓4100而推动滑动件4170。在这种情况下，滑动件4170可不从仓盘4180射出并且可与外科缝合器保持在一起，而在其中滑动件4170不附接到驱动棒的其他情况中，滑动件4170可留在手术部位中。在任何情形中，对上文进行进一步描述，仓体4110的可压缩性可允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。作为在砧座闭合时钉被至少部分地变形的结果，可使用较高的钉(诸如具有大约0.18"钉高度的钉)，例如其中大约0.12"的钉高度可被定位在可压缩层4110中，并且其中可压缩层4110可具有大约0.14"的未压缩高度。
如本文所述，钉仓中可在其中包括多个钉。任选地，此类钉可由被变形为基本上U形构型并具有两个钉腿的金属线材构成。可设想出其中钉可包括不同构型(诸如被接合在一起并具有三个或更多个钉腿的两个或更多个线材)的替代形式。用于形成钉的一个或多个线材可包括圆的或至少基本上圆的横截面。钉线材可包括任何其他合适的横截面，诸如正方形和/或矩形的横截面。钉可由塑料线材构成。钉可由涂覆有塑料的金属线材构成。根据本发明，仓可包括除钉之外或取代钉的任何合适类型的紧固件。例如，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。可使用两部分的紧固件。例如，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。如上所述，可在钉仓内推进滑动件或驱动器以便完成钉的成形过程。可在砧座内推进滑动件或驱动器，以便使一个或多个成形构件向下运动至与相对的钉仓和钉或定位在钉仓中的紧固件接合。
如本文所述，钉仓可包括储存于其中的四个钉行。所述四个钉行可被布置成两个内侧钉行和两个外侧钉行。例如，内侧钉行和外侧钉行可被定位在钉仓内的切割构件或刀狭槽的第一侧上；相似地，内侧钉行和外侧钉行可被定位在切割构件或刀狭槽的第二侧上。钉仓可不包括切割构件狭槽；然而，作为钉仓狭槽的替代，这种钉仓可包括能够由切割构件切割的指定部分。相似地，可将内侧钉行布置在钉仓内，使得其与切割构件狭槽等距地或至少基本上等距地间隔开。相似地，可将外侧钉行布置在钉仓内，使得其与切割构件狭槽等距地或至少基本上等距地间隔开。根据本发明，钉仓可包括储存在钉仓内的多于或少于四个钉行。钉仓可包括六个钉行。例如，钉仓可在切割构件狭槽的第一侧上包括三个钉行，并且在切割构件狭槽的第二侧上包括三个钉行。钉仓可包括奇数个钉行。例如，钉仓可在切割构件狭槽的第一侧上包括两个钉行，并且在切割构件狭槽的第二侧上包括三个钉行。钉排可包括具有相同或至少基本上相同的未成形钉高度的钉。作为另外一种选择，一个或多个钉行可包括具有与其他钉不同的未成形钉高度的钉。例如，切割构件狭槽的第一侧上的钉可具有第一未成形高度，并且切割构件狭槽的第二侧上的钉可具有第二未成形高度，该第二未成形高度不同于第一高度。
任选地，如上所述，钉仓可包括仓体，该仓体包括多个限定于其中的钉腔。仓体可包括平台和顶部平台表面，其中每个钉腔可限定平台表面中的开口。还如上所述，钉可被定位在每个钉腔内，使得钉被储存在仓体内直到其从仓体被射出。在从仓体被射出之前，钉可被容纳在仓体内，使得钉不突起到平台表面上方。在此类情况下，当钉被定位在平台表面下方时，可减少钉被损坏和/或过早接触目标组织的可能性。在各种情况下，钉可在未击发位置和击发位置之间运动，在未击发位置中，其不从仓体突起，在击发位置中，其已从仓体露出并可接触被定位在钉仓对面的砧座。砧座和/或限定于砧座内的成形凹坑可被定位成距平台表面上方预定距离，使得当钉从仓体被部署时，钉变形至预定的成形高度。在一些情况下，被捕获在砧座和钉仓之间的组织的厚度可变化，因此，较厚的组织可被捕获在某些钉内而较薄的组织可被捕获在某些其他钉内。在任一种情况下，由钉施加到组织的夹紧压力或力例如可因钉而异，或在钉行的一端上的钉和钉行的另一端上的钉之间变化。在某些情况下，可控制砧座和钉仓平台之间的间隙，使得钉在每个钉内施加某一最小的夹紧压力。然而在一些此类情况下，在不同的钉内的夹紧压力的显著变化可能仍然存在。外科缝合器械在2008年6月3日公布的美国专利7,380,696中有所公开，该专利的全部公开内容以引用方式并入本文。用于外科缝合和切断器械的例证性多行程柄部在共同未决以及共同拥有的名称为“SURGICAL STAPLING INSTRUMENT INCORPORATING AMULTISTROKE FIRING POSITION INDICATOR AND RETRACTIONMECHANISM”的美国专利申请序列号10/374,026中进行了更详细的描述，该专利申请的公开内容据此全文以引用方式并入。符合本发明的其他应用可结合单击发行程，诸如在共同未决以及共同拥有的名称为“SURGICALSTAPLING INSTRUMENT HAVING SEPARATE DISTINCT CLOSING ANDFIRING SYSTEMS”美国专利申请序列号10/441,632中所描述的，该专利申请的公开内容据此全文以引用方式并入。
如本文所述，钉仓可包括如下装置：该装置用于对从钉仓部署的钉内捕获的组织的厚度进行补偿。参见图14，钉仓(诸如钉仓10000)例如可包括刚性的第一部分(诸如支撑部分10010)以及可压缩的第二部分(诸如厚度补偿件10020)。首先参见图16，支撑部分10010可包括仓体、顶部平台表面10011和多个钉腔10012。其中，类似于上文所述，每个钉腔10012可限定平台表面10011中的开口。钉10030例如可被可移除地定位在每个钉腔10012中。例如，每个钉10030可包括基部10031和从基部10031延伸的一个或多个变形腿10032。在钉10030被部署之前，还如下文更详细所述，钉10030的基部10031可由定位在支撑部分10010内的钉驱动器支撑，并且同时，钉10030的腿10032可至少被部分容纳在钉腔10012内。钉10030可在未击发位置和击发位置之间被部署，使得腿10032运动穿过组织厚度补偿件10020，穿透组织厚度补偿件10020的顶部表面，穿透组织T，并且接触被定位在钉仓10000对面的砧座。当腿10032抵靠砧座变形时，每个钉10030的腿10032可捕获组织厚度补偿件10020的一部分以及每个钉10030内的组织T的一部分，并且将压缩力施加到组织。对上文进行进一步描述，可使每个钉10030的腿10032向下朝钉的基部10031变形，以形成钉截留区域10039，在该钉截留区域，组织T和组织厚度补偿件10020可被捕获。在各种情况下，钉截留区域10039可被限定在已变形的腿10032的内表面和基部10031的内表面之间。钉截留区域的尺寸可取决于若干因素，例如腿的长度、腿的直径、基部的宽度、和/或例如腿变形的程度。
此前，外科医生常常需要针对正被缝合的组织来选择具有适当钉高度的适当钉。例如，外科医生可选择高的钉与厚组织一起使用以及选择低的钉与薄组织一起使用。然而在一些情形下，正被缝合的组织不具有一致的厚度，因此，一些钉无法实现期望的击发构型。例如，图48示出了用于薄组织中的高的钉。现在参见图49，当组织厚度补偿件(诸如组织厚度补偿件10020)例如与薄组织一起使用时，例如较大的钉可成形为期望的击发构型。
由于组织厚度补偿件的压缩率，组织厚度补偿件可对捕获在每个钉内的组织的厚度进行补偿。更具体地，现在参见图43和图44，组织厚度补偿件(例如组织厚度补偿件10020)例如可根据钉截留区域10039内容纳的组织的厚度和/或类型来占据每个钉10030的钉截留区域10039的较大和/或较小部分。例如，在较厚的组织T被捕获在钉10030内的情况下，如果较薄的组织T被捕获在钉10030内，则组织厚度补偿件10020可占据钉截留区域10039的较大部分。相应地，相较于较薄的组织T被捕获在钉10030内的情况，如果较厚的组织T被捕获在钉10030内，则组织厚度补偿件10020可占据钉截留区域10039的较小部分。这样，组织厚度补偿件可补偿较薄组织和/或较厚组织，并确保压缩力被施加到组织，而不论或至少基本上不论被捕获在钉内的组织厚度如何。除了上文所述之外，组织厚度补偿件10020可对被捕获在不同钉10030内的不同类型或不同压缩率的组织进行补偿。现在参见图44，组织厚度补偿件10020可将压缩力施加到可包括血管V的血管组织T，并因此限制血液流过不太可压缩的血管V，但是仍然将期望的压缩压力施加到周围的组织T。在各种情况下，对上文进行进一步描述，组织厚度补偿件10020还可补偿已变形的钉。参见图45，各种钉10030的变形可导致限定于此类钉内的较大的钉截留区域10039。由于组织厚度补偿件10020的回弹力，现在参见图46，即使被限定于此类已变形钉10030内的钉截留区域10039可被扩大，定位在已变形钉10030内的组织厚度补偿件10020仍可将足够的压缩力施加到组织。在各种情况下，位于相邻钉10030中间的组织厚度补偿件10020可被已变形钉10030周围的适当成形的钉10030抵靠组织T偏置，并因此将压缩压力施加到例如围绕和/或被捕获在已变形钉10030内的组织。在各种情况下，组织厚度补偿件可补偿不同的组织密度，所述不同的组织密度可例如由于钙化、纤维区域、和/或先前已缝合或处理的组织而产生。
根据本发明，固定的或不可改变的组织间隙可被限定在支撑部分和砧座之间，因此不论被捕获在钉内的组织的厚度如何均可使钉变形至预定的高度。当组织厚度补偿件用于此类情况时，组织厚度补偿件可适应被捕获在砧座和支撑部分钉仓之间的组织，并且由于组织厚度补偿件的回弹力，组织厚度补偿件可将附加的压缩力施加到组织。现在参见图50-55，钉10030已成形为预定的高度H。参照图50，组织厚度补偿件没有被使用，并且组织T占据了整个钉截留区域10039。参照图57，组织厚度补偿件10020的一部分已被捕获在钉10030内，已将组织T压缩，并且已占据钉截留区域10039的至少一部分。现在参见图52，薄组织T已被捕获在钉10030内。在该实施例中，被压缩的组织T具有大约2/9H的高度，并且被压缩的组织厚度补偿件10020具有例如大约7/9H的高度。现在参见图53，具有中间厚度的组织T已被捕获在钉10030内。在该实施例中，被压缩的组织T具有大约4/9H的高度，并且被压缩的组织厚度补偿件10020具有例如大约5/9H的高度。现在参见图54，具有中间厚度的组织T已被捕获在钉10030内。在该实施例中，被压缩的组织T具有大约2/3H的高度，并且被压缩的组织厚度补偿件10020具有例如大约1/3H的高度。现在参见图53，厚组织T已被捕获在钉10030内。在该实施例中，被压缩的组织T具有大约8/9H的高度，并且被压缩的组织厚度补偿件10020具有例如大约1/9H的高度。在各种情况下，组织厚度补偿件可包括压缩高度，该压缩高度包括：例如大约10％的钉截留高度、大约20％的钉截留高度、大约30％的钉截留高度、大约40％的钉截留高度、大约50％的钉截留高度、大约60％的钉截留高度、大约70％的钉截留高度、大约80％的钉截留高度、和/或大约90％的钉截留高度。
钉10030可包括任何合适的未成形高度。钉10030可包括例如介于大约2mm和大约4.8mm之间的未成形高度。钉10030可包括例如大约2.0mm、大约2.5mm、大约3.0mm、大约3.4mm、大约3.5mm、大约3.8mm、大约4.0mm、大约4.1mm、和/或大约4.8mm的未成形高度。钉可变形的高度H可由支撑部分10010的平台表面10011和相对的砧座之间的距离来决定。平台表面10011和砧座的组织接触表面之间的距离可例如为大约0.097"。高度H还可由限定在砧座内的成形凹坑的深度决定。成形凹坑可例如具有从组织接触表面测得的深度。任选地，如下文更详细所述，钉仓10000还可包括钉驱动器，该钉驱动器可将钉10030朝砧座抬起，并且将钉抬起或“过度驱动”到平台表面10011上方。在这种情况下，钉10030的成形高度H还可由钉10030被过度驱动的距离来决定。例如，钉10030可被过度驱动例如大约.028"，并且可导致钉10030被成形为例如大约0.189"的高度。钉10030可被成形为例如大约0.8mm、大约1.0mm、大约1.5mm、大约1.8mm、大约2.0mm、和/或大约2.25mm的高度。钉可被成形为例如介于大约2.25mm和大约3.0mm之间的高度。对上文进行进一步描述，钉的钉截留区域的高度可由钉的成形高度以及包括钉的线材的宽度和直径所决定。钉10030的钉截留区域10039的高度可包括钉的成形高度H减去线材的两个直径宽度。钉线材可包括例如大约0.0089"的直径。钉线材可包括例如介于大约0.0069"和大约0.0119"之间的直径。例如，钉10030的成形高度H可为大约0.189"，并且钉线材直径可为大约0.0089"，从而例如产生大约0.171"的钉截留高度。
对上文进行进一步描述，组织厚度补偿件可包括未压缩的或预部署的高度，并且能够变形为多个压缩高度中的一个。组织厚度补偿件可包括例如大约0.125"的未压缩高度。组织厚度补偿件可包括例如大于或等于大约0.080"的未压缩高度。组织厚度补偿件可包括未压缩的或预部署的高度，该高度大于钉的未击发高度。组织厚度补偿件的未压缩的或预部署的高度可比钉的未击发高度例如高大约10％、高大约20％、高大约30％、高大约40％、高大约50％、高大约60％、高大约70％、高大约80％、高大约90％、和/或高大约100％。组织厚度补偿件的未压缩的或预部署的高度可比钉的未击发高度高例如至多大约100％。组织厚度补偿件的未压缩的或预部署的高度可比钉的未击发高度高例如超过100％。组织厚度补偿件可包括等于钉的未击发高度的未压缩高度。组织厚度补偿件可包括小于钉的未击发高度的未压缩高度。组织厚度补偿件的未压缩的或预部署的高度可比钉的未击发高度例如低大约10％、低大约20％、低大约30％、低大约40％、低大约50％、低大约60％、低大约70％、低大约80％、和/或低大约90％。可压缩的第二部分可包括未压缩高度，该未压缩高度高于正被缝合的组织T的未压缩高度。组织厚度补偿件可包括未压缩高度，该未压缩高度等于正被缝合的组织T的未压缩高度。组织厚度补偿件可包括未压缩高度，该未压缩高度低于正被缝合的组织T的未压缩高度。
如上所述，不论是厚组织还是薄组织被捕获在钉内，组织厚度补偿件均可在多个成形钉内被压缩。例如，可使钉线或钉行内的钉变形，使得每个钉的钉截留区域包括例如大约2.0mm的高度，其中组织T和组织厚度补偿件可被压缩到该高度以内。在某些情形下，组织T可包括在钉截留区域内的大约1.75mm的压缩高度，而组织厚度补偿件可包括在钉截留区域内的大约0.25mm的压缩高度，从而得到总计为例如大约2.0mm的钉截留区域高度。在某些情形下，组织T可包括在钉截留区域内的大约1.50mm的压缩高度，而组织厚度补偿件可包括在钉截留区域内的大约0.50mm的压缩高度，从而得到总计为例如大约2.0mm的钉截留区域高度。在某些情形下，组织T可包括在钉截留区域内的大约1.25mm的压缩高度，而组织厚度补偿件可包括在钉截留区域内的大约0.75mm的压缩高度，从而得到总计为例如大约2.0mm的钉截留区域高度。在某些情形下，组织T可包括在钉截留区域内的大约1.0mm的压缩高度，而组织厚度补偿件可包括在钉截留区域内的大约1.0mm的压缩高度，从而得到总计为例如大约2.0mm的钉截留区域高度。在某些情形下，组织T可包括在钉截留区域内的大约0.75mm的压缩高度，而组织厚度补偿件可包括在钉截留区域内的大约1.25mm的压缩高度，从而得到总计为例如大约2.0mm的钉截留区域高度。在某些情形下，组织T可包括在钉截留区域内的大约1.50mm的压缩高度，而组织厚度补偿件可包括在钉截留区域内的大约0.50mm的压缩高度，从而得到总计为例如大约2.0mm的钉截留区域高度。在某些情形下，组织T可包括在钉截留区域内的大约0.25mm的压缩高度，而组织厚度补偿件可包括在钉截留区域内的大约1.75mm的压缩高度，从而得到总计为例如大约2.0mm的钉截留区域高度。
对上文进行进一步描述，组织厚度补偿件可包括小于钉的击发高度的未压缩高度。组织厚度补偿件可包括等于钉的击发高度的未压缩高度。组织厚度补偿件可包括高于钉的击发高度的未压缩高度。例如，组织厚度补偿件的未压缩高度可包括例如以下厚度，该厚度为成形钉高度的大约110％、成形钉高度的大约120％、成形钉高度的大约130％、成形钉高度的大约140％、成形钉高度的大约150％、成形钉高度的大约160％、成形钉高度的大约170％、成形钉高度的大约180％、成形钉高度的大约190％、和/或成形钉高度的大约200％。组织厚度补偿件可包括未压缩高度，该未压缩高度为钉的击发高度的两倍以上。组织厚度补偿件可包括压缩高度，该压缩高度为例如成形钉高度的大约85％至大约150％。任选地，如上所述，组织厚度补偿件可被压缩成介于未压缩厚度和压缩厚度之间。组织厚度补偿件的压缩厚度可例如为其未压缩厚度的大约10％、其未压缩厚度的大约20％、其未压缩厚度的大约30％、其未压缩厚度的大约40％、其未压缩厚度的大约50％、其未压缩厚度的大约60％、其未压缩厚度的大约70％、其未压缩厚度的大约80％、和/或其未压缩厚度的大约90％。组织厚度补偿件的未压缩厚度可例如比其压缩厚度厚大约两倍、大约十倍、大约五十倍、和/或大约一百倍。组织厚度补偿件的压缩厚度可介于其未压缩厚度的大约60％和大约99％之间。组织厚度补偿件的未压缩厚度可比其压缩厚度厚至少50％。组织厚度补偿件的未压缩厚度可比其压缩厚度厚至多一百倍。可压缩的第二部分可为弹性的，或至少部分弹性的，并且可将组织T抵靠钉的变形腿偏置。例如，可压缩的第二部分可在组织T和钉的基部之间弹性扩展，以便抵靠钉的腿推压组织T。如下文进一步详细所述，组织厚度补偿件可被定位在组织T和变形钉腿中间。在各种情况下，由于上文所述，组织厚度补偿件能够消除钉截留区域内的任何间隙。
组织厚度补偿件可包括由下述特性中的一个或多个表征的材料：例如，生物相容性、生物吸收性、生物再吸收性、生物耐用性、生物降解性、可压缩性、流体吸收性、溶胀性、自膨胀性、生物活性、药物、药物活性、抗粘附性、止血性、抗菌性、抗微生物性、抗病毒性、营养性、粘合性、渗透性、亲水性、和/或疏水性。根据本发明，包括砧座和钉仓的外科器械可包括与砧座和/或钉仓相关的组织厚度补偿件，所述组织厚度补偿件包括以下材料中的至少一种：止血剂(例如，血纤维蛋白和凝血酶)、抗生素(例如，doxycpl)、和药物(例如，基质金属蛋白酶(MMP))。
组织厚度补偿件可包括合成和/或非合成材料。组织厚度补偿件可包括聚合物组合物，所述聚合物组合物包括一种或多种合成聚合物和/或一种或多种非合成聚合物。合成聚合物可包括合成的可吸收聚合物和/或合成的非可吸收聚合物。聚合物组合物可包括例如生物相容性泡沫。生物相容性泡沫可包括例如多孔的开孔泡沫和/或多孔的闭孔泡沫。生物相容性泡沫可具有均匀的孔形态或可具有梯度孔形态(即，在一个方向的整个泡沫厚度上，小孔尺寸逐渐增加变成大孔)。聚合物组合物可包括多孔支架、多孔基质、凝胶基质、水凝胶基质、溶液基质、丝状基质、管状基质、复合基质、膜基质、生物稳定聚合物和可生物降解的聚合物中的一种或多种、以及它们的组合。例如，组织厚度补偿件可包括通过丝状基质增强的泡沫，或可包括具有附加的水凝胶层的泡沫，该附加的水凝胶层在体液存在下扩展，以在组织上进一步提供压缩。根据本发明，组织厚度补偿件还可由材料和/或第二层或第三层上的涂层构成，该涂层在体液存在下扩展，以在组织上进一步提供压缩。此类层可为水凝胶，该水凝胶可为合成的和/或天然源材料，并且例如可为生物耐用的和/或可生物降解的。组织厚度补偿件可包括微凝胶或纳米凝胶。水凝胶可包括来自碳水化合物的微凝胶和/或纳米凝胶。可使用能提供附加柔韧性、刚度、和/或强度的纤维非织造材料或纤维网眼类型元件来增强组织厚度补偿件。根据本发明，组织厚度补偿件具有多孔形态，该多孔形态表现出梯度结构，例如在一个表面上的小孔以及在另一个表面上的较大的孔。此类形态对于组织生长或止血行为而言更为理想。此外，梯度还可与变化的生物吸收剖面相组合。短期吸收剖面可为优选的，以解决止血问题，而长期吸收剖面可解决无渗漏情形下使组织更好愈合的问题。
非合成材料的例子包括但不限于冻干多糖、糖蛋白、牛心包膜、胶原、明胶、血纤维蛋白、纤维蛋白原、弹性蛋白、蛋白聚糖、角蛋白、白蛋白、羟乙基纤维素、纤维素、氧化纤维素、氧化再生纤维素(ORC)、羟丙基纤维素、羧乙基纤维素、羧甲基纤维素、甲壳质、脱乙酰壳多糖、酪蛋白、藻酸盐以及它们的组合。
合成可吸收材料的例子包括但不限于聚(乳酸)(PLA)、聚(L-乳酸)(PLLA)、聚已内酯(PCL)、聚乙醇酸(PGA)、聚(三亚甲基碳酸酯)(TMC)、聚对苯二甲酸乙二醇酯(PET)、聚羟基链烷酸酯(PHA)、乙交酯和ε-己内酯(PGCL)的共聚物、乙交酯和三亚甲基碳酸酯的共聚物、聚(癸二酸甘油酯)(PGS)、聚(二氧杂环己酮)(PDS)、聚酯、聚(原酸酯)、聚含氧酸酯、聚醚酯、聚碳酸酯、聚酰胺酯、聚酸酐、多糖、聚(酯-酰胺)、酪氨酸基聚芳酯、聚胺、酪氨酸基聚亚氨碳酸酯、酪氨酸基聚碳酸酯、聚(D,L-丙交酯-氨基甲酸酯)、聚(羟基丁酸酯)、聚(B-羟基丁酸酯)、聚(E-己内酯)、聚乙二醇(PEG)、聚[二(羧基苯氧基)磷腈]、聚(氨基酸)、拟聚(氨基酸)、可吸收聚氨酯、聚(膦嗪)、聚磷腈、聚氧化烯、聚丙烯酰胺、聚甲基丙烯酸羟乙酯、聚乙烯吡咯烷酮、聚乙烯醇、聚(己内酯)、聚丙烯酸、聚乙酸酯、聚丙烯、脂族聚酯、甘油、共聚(醚-酯)、聚草酸亚烷基二醇酯、聚酰胺、聚(亚氨基碳酸酯)、聚草酸亚烷基二醇酯以及它们的组合。聚酯可选自聚丙交酯、聚乙交酯、三亚甲基碳酸酯、聚二氧杂环己酮、聚己内酯、聚丁烯酯、以及它们的组合。
合成的可吸收聚合物可包括例如可以商标名称VICRYL(polyglactic 910)从Ethicon,Inc.商购获得的90/10聚(乙交酯-L-丙交酯)共聚物、可以商标名称DEXON从American Cyanamid Co.商购获得的聚乙交酯、可以商标名称PDS从Ethicon,Inc.商购获得的聚二氧杂环己酮、可以商标名称MAXON从American Cyanamid Co.商购获得的聚(乙交酯-三亚甲基碳酸酯)无规嵌段共聚物、可以商标名称MONOCRYL从Ethicon公司商购获得的75/25聚(乙交酯-ε-己内酯-poliglecaprolactone 25)共聚物中的一种或多种。
合成的非可吸收材料包括但不限于聚氨酯、聚丙烯(PP)、聚乙烯(PE)、聚碳酸酯、聚酰胺，z诸如尼龙、聚氯乙烯(PVC)、聚甲基丙烯酸甲酯(PMMA)、聚苯乙烯(PS)、聚酯、聚醚醚酮(PEEK)、聚四氟乙烯(PTFE)、聚三氟氯乙烯(PTFCE)、聚氟乙烯(PVF)、氟化乙烯丙烯(FEP)、聚缩醛、聚砜、硅、以及它们的组合。合成的非可吸收聚合物可包括但不限于弹性体泡沫塑料和多孔弹性体，例如硅氧烷、聚异戊二烯和橡胶。合成聚合物可包括可以商标名称GORE-TEX软组织补片从W.L.Gore&Associates,Inc.商购获得的膨体聚四氟乙烯(ePTFE)，以及可以商标名称NASOPORE从Polyganics商购获得的共-聚醚酯氨基甲酸酯泡沫塑料。
聚合物组合物可包括例如按重量计大约50％到大约90％的PLLA的聚合物组合物、以及按重量计大约50％到大约10％的PCL的聚合物组合物。聚合物组合物可包括例如按重量计大约70％的PLLA、以及按重量计大约30％的PCL。聚合物组合物可包括例如按重量计大约55％到大约85％的PGA的聚合物组合物、以及按重量计15％到45％的PCL的聚合物组合物。聚合物组合物可包括例如按重量计大约65％的PGA、以及按重量计大约35％的PCL。聚合物组合物可包括例如按重量计大约90％到大约95％的PGA的聚合物组合物、以及按重量计大约5％到大约10％的PLA的聚合物组合物。
合成的可吸收聚合物可包括可生物吸收的、生物相容性的弹性体共聚物。合适的可生物吸收的、生物相容性的弹性体共聚物包括但不限于ε-己内酯和乙交酯的共聚物(ε-己内酯与乙交酯的摩尔比优选地为约30:70至约70:30，优选地为35:65至约65:35，更优选地为45:55至35:65)；ε-己内酯和丙交酯(包括L-丙交酯、D-丙交酯、它们的共混物或乳酸共聚物)的弹性体共聚物(ε-己内酯与丙交酯的摩尔比优选地为约35:65至约65:35，并且更优选地为45:55至30:70)；对二氧杂环己酮(1,4-二氧杂环己烷-2-酮)和丙交酯(包括L-丙交酯、D-丙交酯和乳酸)的弹性体共聚物(对二氧杂环己酮与丙交酯的摩尔比优选地为约40:60至约60:40)；ε-己内酯和对二氧杂环己酮的弹性体共聚物(ε-己内酯与对二氧杂环己酮的摩尔比优选地为约30:70至约70:30)；对二氧杂环己酮和三亚甲基碳酸酯的弹性体共聚物(对二氧杂环己酮与三亚甲基碳酸酯的摩尔比优选为约30:70至约70:30)；三亚甲基碳酸酯和乙交酯的弹性体共聚物(三亚甲基碳酸酯与乙交酯的摩尔比优选为约30:70至约70:30)；三亚甲基碳酸酯和丙交酯的弹性体共聚物，包括L-丙交酯、D-丙交酯、它们的共混物或乳酸共聚物(三亚甲基碳酸酯与丙交酯的摩尔比优选为约30:70至约70:30)；以及它们的共混物。弹性体共聚物可为乙交酯和ε-己内酯的共聚物作为另外一种选择，弹性体共聚物为丙交酯和ε-己内酯的共聚物。
公布于1995年11月21日的名称为“ELASTOMERIC MEDICALDEVICE”的美国专利5,468,253以及公布于2001年12月4日的名称为“FOAM BUTTRESS FOR STAPLING APPARATUS”用于的美国专利6,325,810的公开内容各自全文以引用的方式并入本文。
组织厚度补偿件可包含乳化剂。乳化剂的例子可包括但不限于水溶性聚合物，诸如聚乙烯醇(PVA)、乙烯吡咯烷酮(PVP)、聚乙二醇(PEG)、聚丙二醇(PPG)、普流罗尼(PLURONICS)、吐温(TWEENS)、多糖以及它们的组合。
组织厚度补偿件可包含表面活性剂。
表面活性剂的例子可包括但不限于聚丙烯酸、甲基化酶、甲基纤维素、乙基纤维素、丙基纤维素、羟基乙基纤维素、羧基甲基纤维素、聚氧乙烯十六烷基醚、聚氧乙烯月桂基醚、聚氧乙烯辛基醚、聚氧乙烯辛基苯基醚、聚氧乙烯油基醚、聚氧乙烯脱水山梨糖醇单月桂酸酯、聚氧乙烯硬脂基醚、聚氧乙烯壬基苯基醚、二烷基苯氧基聚(乙烯氧基)乙醇、和泊洛沙姆。
聚合物组合物可包括药物活性剂。聚合物组合物可释放治疗有效量的药物活性剂。药物活性剂可在聚合物组合物被解吸或吸收时释放。药物活性剂可被释放到流经聚合物组合物之上或穿过聚合物组合物的流体(例如，血液)内。药物活性剂的例子可包括但不限于止血剂和药物，例如血纤维蛋白、凝血酶和氧化再生纤维素(ORC)；抗炎剂药物，例如双氯芬酸、阿司匹林、萘普生、舒林酸和氢化可的松；抗生素和抗微生物药物或抗微生物剂，例如三氯生、离子银、氨苄青霉素、庆大霉素、多粘菌素B、氯霉素；以及抗癌剂，例如顺铂、丝裂霉素、阿霉素。
聚合物组合物可包括止血材料。组织厚度补偿件可包含止血材料，其包括聚(乳酸)、聚(乙醇酸)、聚(羟基丁酸酯)、聚(己内酯)、聚(二氧杂环己酮)、聚氧化烯、共聚(醚-酯)、胶原、明胶、凝血酶、血纤维蛋白、纤维蛋白原、纤粘蛋白、弹性蛋白、白蛋白、血红蛋白、卵清蛋白、多糖、透明质酸、硫酸软骨素、羟乙基淀粉、羟乙基纤维素、纤维素、氧化纤维素、羟丙基纤维素、羧乙基纤维素、羧甲基纤维素、甲壳质、脱乙酰壳多糖、琼脂糖、麦芽糖、麦芽糖糊精、海藻酸盐、凝血因子、甲基丙烯酸盐、聚氨酯、丙烯酸酯、血小板激动剂、血管收缩剂、矾、钙、RGD肽、蛋白质、鱼精蛋白硫酸盐、ε-氨基己酸、硫酸铁、碱式硫酸铁、氯化铁、锌、氯化锌、氯化铝、硫酸铝、醋酸铝、高锰酸盐、单宁酸、骨蜡、聚乙二醇、岩藻聚糖以及它们的组合。组织厚度补偿件的特征可在于止血特性。
组织厚度补偿件的聚合物组合物的特征在于例如百分孔隙率、孔尺寸、和/或硬度。聚合物组合物可具有例如按体积计大约30％到大约99％的百分孔隙率。聚合物组合物可具有例如按体积计大约60％到大约98％的百分孔隙率。聚合物组合物可具有例如按体积计大约85％到大约97％的百分孔隙率。聚合物组合物可包括例如按重量计大约70％的PLLA和按重量计大约30％的PCL，并且可包括例如按体积计大约90％的孔隙率。例如，因此，聚合物组合物将包括按体积计大约10％的共聚物。聚合物组合物可包括例如按重量计大约65％的PGA和按重量计大约35％的PCL，并且可具有例如按体积计大约93％到大约95％的百分孔隙率。聚合物组合物可包括按体积计大于85％的孔隙率。聚合物组合物可具有例如大约5微米到大约2000微米的孔尺寸。聚合物组合物可具有例如介于大约10微米到大约100微米之间的孔尺寸。例如，聚合物组合物可包括例如PGA和PCL的共聚物。聚合物组合物可具有例如介于大约100微米到大约1000微米之间的孔尺寸。例如，聚合物组合物可包括例如PLLA和PCL的共聚物。
根据某些方面，聚合物组合物的硬度可以肖氏硬度表示。该肖氏硬度可被定义为诸如由肖氏硬度计所测定的对材料的永久凹痕的耐受性。为了评估给定材料的硬度计值，根据名称为“Standard Test Method for RubberProperty-Durometer Hardness”的ASTM程序D2240-00，用硬度计压头脚将压力施加至材料，其全文以引用的方式并入本文。可将硬度计压头脚施用到材料并持续足够的一段时间，诸如15秒，例如，其中读数从合适的标度读取。根据所用的标度类型，当压头脚完全穿透材料时，可获得读数0，并且当材料未被穿透时，可获得读数100。该读数无量纲。可例如根据ASTMD2240-00利用任何合适的标度(例如，A类和/或OO类标度)来决定硬度计。组织厚度补偿件的聚合物组合物可具有大约4A到大约16A的肖氏A硬度值，该肖氏A硬度值例如在大约45OO到大约65OO的肖氏OO范围。例如，聚合物组合物可包括例如PLLA/PCL共聚物或PGA/PCL共聚物。组织厚度补偿件的聚合物组合物可具有小于15A的肖氏A硬度值。组织厚度补偿件的聚合物组合物可具有小于10A的肖氏A硬度值。组织厚度补偿件的聚合物组合物可具有小于5A的肖氏A硬度值。聚合物材料可具有例如大约35OO到大约75OO的肖氏OO组合物值。
聚合物组合物可具有上述识别出的特性中的至少两种。聚合物组合物可具有上述识别出的特性中的至少三种。聚合物组合物可具有例如按体积计85％到97％的孔隙率、5微米到2000微米的孔尺寸、和4A到16A的肖氏A硬度值以及45OO到65OO的肖氏OO硬度值。聚合物组合物可包括按重量计70％的PLLA的聚合物组合物以及按重量计30％的PCL的聚合物组合物；所述聚合物组合物具有例如按体积计90％的孔隙率、100微米到1000微米的孔尺寸、和4A到16A的肖氏A硬度值以及45OO到65OO的肖氏OO硬度值。聚合物组合物可包括按重量计65％的PGA的聚合物组合物以及按重量计35％的PCL的聚合物组合物；所述聚合物组合物具有例如按体积计93％到95％的孔隙率、10微米到100微米的孔尺寸、和4A到16A的肖氏A硬度值以及45OO到65OO的肖氏OO硬度值。
厚度组织补偿件可包括扩展的材料。如上所述，组织厚度补偿件可包含在未压缩或部署时扩展的压缩材料。组织厚度补偿件可包含原位形成的自扩展材料。组织厚度补偿件可包含至少一种前体，所述前体被选择以在接触其他前体、水、和/或体液中的至少一者时自发地交联。根据本发明，第一前体可接触一个或多个其他前体以形成可扩展的和/或可溶胀的组织厚度补偿件。组织厚度补偿件可包含流体可溶胀的组合物，例如，水可溶胀的组合物。组织厚度补偿件可包含含水凝胶。
组织厚度补偿件可包括具有封装件的可生物降解泡沫，所述封装件包括嵌入其中的干燥水凝胶颗粒或颗粒剂。不受任何具体理论的束缚，泡沫中的封装件可通过使水凝胶前体的水性溶液和生物相容性材料的有机溶液接触以形成泡沫而形成。水性溶液和有机溶液可形成胶束。水性溶液和有机溶液可被干燥以封装泡沫内的干燥水凝胶颗粒或颗粒剂。例如，水凝胶前体(诸如亲水性聚合物)可溶解于水以形成胶束的分散体。水性溶液可接触包含聚(乙醇酸)和聚己内酯的二氧杂环己烷的有机溶液。水性溶液和有机溶液可被冻干从而形成具有分散其中的干燥水凝胶颗粒或颗粒剂的生物可降解的泡沫。不受任何具体理论的束缚，但据信，胶束形成封装件，所述封装件具有分散在泡沫结构内的干燥水凝胶颗粒或颗粒剂。该封装件可破裂，并且干燥水凝胶颗粒或颗粒剂可接触流体(诸如体液)并扩展。
任选地，如上所述，组织厚度补偿件可包括初始厚度和扩展厚度。组织厚度补偿件的初始厚度可例如为其扩展厚度的大约0.001％、其扩展厚度的大约0.01％、其扩展厚度的大约0.1％、其扩展厚度的大约1％、其扩展厚度的大约10％、其扩展厚度的大约20％、其扩展厚度的大约30％、其扩展厚度的大约40％、其扩展厚度的大约50％、其扩展厚度的大约60％、其扩展厚度的大约70％、其扩展厚度的大约80％、和/或其扩展厚度的大约90％。组织厚度补偿件的扩展厚度可例如比其初始厚度厚约2倍、约5倍、约10倍、约50倍、约100倍、约200倍、约300倍、约400倍、约500倍、约600倍、约700倍、约800倍、约900倍、和/或约1000倍。组织厚度补偿件的初始厚度可高达其扩展厚度的1％、高达其扩展厚度的5％、高达其扩展厚度的10％、和高达其扩展厚度的50％。组织厚度补偿件的扩展厚度可比其初始厚度厚至少50％、比其初始厚度厚至少100％、比其初始厚度厚至少300％、和比其初始厚度厚至少500％。如上所述，在各种情况下，组织厚度补偿件能够消除钉截留区域内的任何间隙。
如上所述，组织厚度补偿件可包含水凝胶。水凝胶可包括均聚物水凝胶、共聚物水凝胶、多元聚合物水凝胶、互穿聚合物水凝胶、以及它们的组合。水凝胶可包括微凝胶、纳米凝胶、以及它们的组合。水凝胶可大体包括能够吸收和/或保留流体的亲水性聚合物网络。水凝胶可包括非交联的水凝胶、交联的水凝胶、以及它们的组合。水凝胶可包括化学交联剂、物理交联剂、疏水片段和/或水不溶解的片段。水凝胶可通过聚合反应、小分子交联和/或聚合物-聚合物交联来化学地交联。水凝胶可通过离子相互作用、疏水相互作用、氢键结合相互作用、立体络合和/或超分子化学来物理地交联。水凝胶可因交联剂、疏水片段和/或水不溶解的片段而为基本上不溶解的，但因吸收和/或保持流体而为可扩展和/或溶胀的。前体可与内源性材料和/或组织交联。
水凝胶可包括环境敏感性水凝胶(ESH)。ESH可包括具有与环境条件相关的流体溶胀性特性的材料。环境条件可包括但不限于在手术部位的物理条件、生物条件和/或化学条件。例如，响应于温度、pH、电场、离子强度、酶和/或化学反应、电和/或磁刺激，以及其他生理的和环境的变量，水凝胶可溶胀或收缩。ESH可包括多官能的丙烯酸酯、甲基丙烯酸羟乙酯(HEMA)、弹性体丙烯酸酯、以及相关的单体。
包含水凝胶的组织厚度补偿件可包含上文所述的非合成材料和合成材料中的至少一种。水凝胶可包括合成水凝胶和/或非合成水凝胶。组织厚度补偿件可包括多个层。多个层可包括多孔层和/或无孔层。例如，组织厚度补偿件可包括无孔层和多孔层。又如，组织厚度补偿件可包括第一无孔层和第二无孔层中间的多孔层。又如，组织厚度补偿件可包括第一多孔层和第二多孔层中间的无孔层。无孔层和多孔层可以相对于钉仓和/或砧座的表面按任何顺序定位。
非合成材料的例子可包括但不限于白蛋白、藻酸盐、碳水化合物、酪蛋白、纤维素、甲壳质、脱乙酰壳多糖、胶原、血液、葡聚糖、弹性蛋白、血纤维蛋白、纤维蛋白原、明胶、肝素、透明质酸、角蛋白、蛋白质、血清和淀粉。纤维素可包括羟乙基纤维素、氧化纤维素、氧化再生纤维素(ORC)、羟丙基纤维素、羧乙基纤维素、羧甲基纤维素以及它们的组合。胶原可包括牛心包膜。碳水化合物可包括多糖，诸如冻干多糖。蛋白质可包括糖蛋白、蛋白聚糖、或它们的组合。
合成材料的例子可包括但不限于聚(乳酸)、聚(乙醇酸)、聚(羟基丁酸酯)、聚(膦嗪)、聚酯、聚乙二醇、聚环氧乙烷、聚环氧乙烷-聚环氧丙烷共聚物、共聚环氧乙烷、聚氧化烯、聚丙烯酰胺、聚甲基丙烯酸羟乙酯、聚(乙烯吡咯烷酮)、聚乙烯醇、聚(己内酯)、聚(二氧杂环己酮)、聚丙烯酸、聚乙酸酯、聚丙烯、脂族聚酯、甘油、聚(氨基酸)、共聚(醚-酯)、聚草酸亚烷基二醇酯、聚酰胺、聚(亚氨基碳酸酯)、聚含氧酸酯、聚原酸酯、聚磷腈以及它们的组合。可使用常规的方法合成地制备上述非合成材料，例如合成透明质酸。
水凝胶可由一种或多种水凝胶前体制成。前体可包括单体和/或大分子单体。水凝胶前体可包括亲电体官能团和/或亲核体亲电体官能团。一般来讲，亲电体可与亲核体反应以形成化学键。本文中使用的术语“官能团”是指能够彼此反应以形成化学键的亲电基团或亲核基团。亲电官能团的例子可包括但不限于N-羟基琥珀酰亚胺(“NHS”)、磺基琥珀酰亚胺、羰基二咪唑、磺酰氯、芳基卤化物、磺基琥珀酯、N-羟基琥珀酰亚胺酯、琥珀酰亚胺酯，诸如琥珀酰亚胺琥珀酸酯和/或琥珀酰亚胺丙酸酯、异腈酸酯、硫氰酸酯、碳化二亚胺、苯并三唑碳酸酯、环氧化合物、醛、马来酰亚胺、亚氨酸酯、它们的组合等等。亲电官能团可包括琥珀酰亚胺酯。亲核官能团的例子可包括但不限于-NH2、-SH、-OH、-PH2和-CO-NH-NH2。
水凝胶可由单个前体或多个前体形成。水凝胶可由第一前体和第二前体形成。第一水凝胶前体和第二水凝胶前体在接触时可原位或在体内形成水凝胶。水凝胶前体一般可指聚合物、官能团、大分子、小分子和/或能够参与反应以形成水凝胶的交联剂。前体可包括例如均匀溶液、不均匀的或在适当溶剂中相分离的溶液，诸如水或缓冲液。缓冲液的pH可为例如约8至约12，诸如约8.2至约9。缓冲液的例子可包括但不限于硼酸盐缓冲液。前体可在乳液中。根据本发明，第一前体可与第二前体反应以形成水凝胶。第一前体可在接触第二前体时自发地交联。根据本发明，第一前体上的第一组亲电官能团可与第二前体上的第二组亲核官能团反应。当前体混合在允许反应的环境中时(例如，当与pH、温度和/或溶剂相关时)，官能团可彼此反应以形成共价键。在前体中的至少一些与不止一个其他的前体反应时，前体可成为交联的。
组织厚度补偿件可包括至少一个单体，所述单体选自3-磺丙基丙烯酸钾盐(“KSPA”)、丙烯酸钠(“NaA”)、N-(三(羟基甲基)甲基)丙烯酰胺(“三丙烯酰基”)和2-丙烯酰胺-2-甲基-1-丙烷磺酸(AMPS)。组织厚度补偿件可包括共聚物，该共聚物包括两个或多个选自KSPA、NaA、三丙烯酰基、AMPS的单体。组织厚度补偿件可包括来源于KSPA、NaA、三丙烯酰基、AMPS的均聚物。组织厚度补偿件可包括可与其共聚的亲水性改性单体。亲水性改性单体可包括甲基丙烯酸甲酯、丙烯酸丁酯、丙烯酸环己酯、苯乙烯、苯乙烯磺酸。
组织厚度补偿件可包括交联剂。交联剂可包括低分子量二或聚乙烯交联剂，诸如乙二醇二丙烯酸酯或二甲基丙烯酸酯、二、三或四乙烯基-乙二醇二丙烯酸酯或二甲基丙烯酸酯、烯丙基(甲基)丙烯酸酯、C2-C8-亚烷基二丙烯酸酯或二甲基丙烯酸酯、二乙烯醚、二乙烯砜、二和三乙烯基苯、三羟甲基丙烷三丙烯酸酯或三甲基丙烯酸酯、季戊四醇四丙烯酸酯或四甲基丙烯酸酯、双酚A二丙烯酸酯或二甲基丙烯酸酯、亚甲基双丙烯酰胺或二甲基丙烯酰胺、乙烯双丙烯酰胺或乙烯二甲基丙烯酰胺、邻苯二甲酸三烯丙酯或邻苯二甲酸二烯丙酯。交联剂可包括N、N'-亚甲基双丙烯酰胺(“MBAA”)。
组织厚度补偿件可包括丙烯酸酯和/或甲基丙烯酸酯官能水凝胶、生物相容性光引发剂、烷基-氰基丙烯酸酯、异氰酸酯官能大分子单体中的至少一者、任选地包括胺官能大分子单体、琥珀酰亚胺酯官能大分子单体、任选地包括胺和/或巯基官能大分子单体、环氧基官能大分子单体、任选地包括胺官能大分子单体、蛋白质和/或多肽和醛交联剂的混合物、京尼平(Genipin)和水可溶解的碳化二亚胺、阴离子多糖和多价阳离子。
组织厚度补偿件可包括不饱和的有机酸单体、丙烯酸取代醇和/或丙烯酰胺。组织厚度补偿件可包括甲基丙烯酸、丙烯酸、甘油丙烯酸酯、甘油甲基丙烯酸酯、2-羟基乙基甲基丙烯酸酯、2-丙烯酸羟乙酯、2-(二甲基氨基乙基)甲基丙烯酸酯、N-乙烯基吡咯烷酮、甲基丙烯酰胺和/或N,N-二甲基丙烯酰胺聚(甲基丙烯酸)。
组织厚度补偿件可包括增强材料。增强材料可包括以上所述的非合成材料和合成材料中的至少一者。增强材料可包括胶原、明胶、血纤维蛋白、纤维蛋白原、弹性蛋白、角蛋白、白蛋白、羟乙基纤维素、纤维素、氧化纤维素、羟丙基纤维素、羧乙基纤维素、羧甲基纤维素、甲壳质、脱乙酰壳多糖、藻酸盐、聚(乳酸)、聚(乙醇酸)、聚(羟基丁酸酯)、聚(膦嗪)、聚酯、聚乙二醇、聚氧化烯、聚丙烯酰胺、聚甲基丙烯酸羟乙酯、聚乙烯吡咯烷酮、聚乙烯醇、聚(己内酯)、聚(二氧杂环己酮)、聚丙烯酸、聚乙酸酯、聚已内酯、聚丙烯、脂族聚酯、甘油、聚(氨基酸)、共聚(醚-酯)、聚草酸亚烷基二醇酯、聚酰胺、聚(亚氨基碳酸酯)、聚草酸亚烷基二醇酯、聚含氧酸酯、聚原酸酯、聚磷腈以及它们的组合。
组织厚度补偿件可包括包含增强材料的层。组织厚度补偿件的多孔层和/或无孔层可包括增强材料。例如，多孔层可包括增强材料并且无孔层可不包括增强材料。增强层可包括第一无孔层和第二无孔层中间的内层。增强层可包括组织厚度补偿件的外层。增强层可包括组织厚度补偿件的外表面。
增强材料可包括网片、单丝、复丝编织物、纤维、垫、毡、颗粒和/或粉剂。增强材料可结合到组织厚度补偿件的层中。增强材料可结合到无孔层和多孔层中的至少一者中。可使用常规技术(诸如针织、编织、梭织和/针织或来形成包括增强材料的网片。
根据本发明，多个加强材料可被取向成随机方向和/或共同方向。共同方向可为例如与钉线平行和与钉线垂直中的一者。例如，单丝和/或复丝编织物可以随机方向和/或共同方向取向。单丝和复丝编织物可与无孔层和/或多孔层相关联。组织厚度补偿件可包括在无孔层内以随机方向取向的多个增强纤维。组织厚度补偿件可包括在无孔层内以共同方向取向的多个增强纤维。
纤维可形成非织造材料，例如，垫和毡。纤维可具有任何适当的长度，例如从0.1mm到100mm和0.4mm到50mm。增强材料可被研磨成粉末。粉末可具有例如从10微米到1厘米的粒度。粉末可结合到组织厚度补偿件中。
组织厚度补偿件可原位形成。水凝胶可原位形成。组织厚度补偿件可通过共价离子和/或疏水键原位形成。物理(非共价)交联可由络合、氢键合、去溶剂化、范德瓦尔斯相互作用、离子键合、以及它们的组合引起。化学(共价)交联可通过以下多种机制中的任何一种来实现：自由基聚合、缩聚、阴离子或阳离子聚合、逐步生长聚合、亲电物质-亲核物质反应、以及它们的组合。
任选地，组织厚度补偿件的原位形成可包括使两个或多个前体反应，所述前体被物理地隔开直到原位接触和/或对环境条件作出反应从而彼此反应以形成水凝胶。原位可聚合的聚合物可由前体制备，所述前体可反应以在手术部位形成聚合物。组织厚度补偿件可通过前体在原位的交联反应形成。前体可包括能够引发用于原位组织厚度补偿件的形成的聚合反应的引发剂。组织厚度补偿件可包括在形成交联水凝胶的应用时可被激活的前体。组织厚度补偿件的原位形成可包括激发至少一个前体以形成化学键，从而形成组织厚度补偿件。任选地，激活可通过在手术部位物理条件、生物条件和/或化学条件的改变来实现，所述条件改变包括但不限于温度、pH、电场、离子强度、酶和/或化学反应、电和/或磁刺激，以及其他生理的和环境变量。前体可接触主体外部并且引入手术部位。
组织厚度补偿件可包括能够在其中储存至少一种组分的一个或多个封装件或单元。封装件能够在其中储存水凝胶前体。例如，封装件能够储存其中的两种组分。封装件能够储存其中的第一水凝胶前体和第二水凝胶前体。第一封装件能够储存其中的第一水凝胶前体并且第二封装件能够储存其中的第二水凝胶前体。如上所述，封装件可与钉腿对齐或至少基本上对齐从而在钉腿接触封装件时刺穿封装件和/或换句话讲使封装件破裂。当部署钉时，该封装件可被压缩、压溃、塌缩和/或换句话讲破裂。封装件破裂之后，储存其中的组分可流出封装件。储存其中的组分可接触其他组分、组织厚度补偿件的层和/或组织。其他组分可来自相同或不同的封装件，在组织厚度补偿件的层中提供和/或通过临床医生用于手术部位。作为以上所述的结果，储存在封装件内的组分可提供组织厚度补偿件的扩展和/或溶胀。
组织厚度补偿件可包括含有封装件的层。封装件可包括与层相关联的空隙、凹坑、圆顶、管以及它们的组合。封装件可包括层中的空隙。层可包括能够附于彼此的两个层，其中封装件可限定于两个层之间。封装件可包括层表面上的圆顶。例如，封装件的至少一部分可被定位在从层向上延伸的圆顶内。封装件可包括在层内形成的凹坑。封装件的第一部分可包括圆顶，而封装件的第二部分可包括凹坑。封装件可包括在层内嵌入的管。管可包括本文所述的非合成材料和/或合成材料，诸如PLA。组织厚度补偿件可包括生物可吸收的泡沫，诸如ORC，所述生物可吸收的泡沫包括嵌入其中的PLA管，并且该管可封装例如水凝胶。封装件可包括互相不连接的分立单元。封装件中的一个或多个可经由延伸穿过层的一个或多个通路、导管、和/或通道而相互流体连通。
来自封装件的组分的释放率可由以下所述来控制：例如组织厚度补偿件的厚度、组织厚度补偿件的组成部分、组分的尺寸、组分的亲水性、和/或在组分中的物理的和/或化学相互作用、组织厚度补偿件的组成部分、和/或外科器械。层可包括一个或多个薄部或弱化部分(诸如局部穿孔)，例如所述一个或多个薄部或弱化部分可有利于切割层并使封装件破裂。局部穿孔可未完全延伸穿过层，而在一些情况下，穿孔可完全延伸穿过层。
任选地，砧座可包括组织厚度补偿件，所述组织厚度补偿件包括具有至少一个微球颗粒的封装组分。组织厚度补偿件可包括封装件，所述封装件包括第一封装组分和第二封装组分。组织厚度补偿件可包括封装件，所述封装件包括第一微球颗粒和第二微球颗粒。
组织厚度补偿件可适于与外科器械一起使用。如上所述，组织厚度补偿件可与钉仓和/或砧座相关联。组织厚度补偿件可构造成适于配合钉仓和/或砧座的任何形状、尺寸和/或维度。如本文所述，组织厚度补偿件可以可释放地附接到钉仓和/或砧座。在缝合过程之前以及在缝合过程期间，组织厚度补偿件可以能够保持组织厚度补偿件与钉仓和/或砧座接触的任何机械的和/或化学的方式附接到钉仓和/或砧座。在钉刺穿组织厚度补偿件以后，可从钉仓和/或砧座中移除或释放组织厚度补偿件。当钉仓和/或砧座移动远离组织厚度补偿件时，可从钉仓和/或砧座中移除或释放组织厚度补偿件。
现在参见图14，钉仓(诸如钉仓10000)例如可包括支撑部分10010和可压缩的组织厚度补偿件10020。现在参见图16-图18，支撑部分10010可包括平台表面10011和限定在支撑部分10010中的多个钉腔10012。每个钉腔10012的尺寸例如可设定成并能够在其中可移除地储存钉，诸如钉10030。钉仓10000还可包括多个钉驱动器10040，当钉10030和钉驱动器10040处于其未击发位置时，每个钉驱动器能够支撑钉腔10012内的一个或多个钉10030。例如，首先参见图22和图23，每个钉驱动器10040可包括例如一个或多个支架或槽10041，该支架或槽能够支撑钉并限制钉10030和钉驱动器10040之间的相对运动。再次参见图16，钉仓10000还可包括钉击发滑动件10050；该钉击发滑动件可从钉仓的近侧末端10001运动到钉仓的远侧末端10002，以便依次将钉驱动器10040和钉10030从其未击发位置向被定位在钉仓10000对面的砧座抬起。首先参见图16和图18，每个钉10030可包括基部10031和从基部10031延伸的一个或多个腿10032，其中每个钉可为例如基本U形和基本V形中的至少一者。钉10030能够使得当钉10030处于其未击发位置时，钉腿10032的顶端相对于支撑部分10010的平台表面10011凹陷。钉10030能够使得当钉10030处于其未击发位置时，钉腿10032的顶端相对于支撑部分10010的平台表面10011齐平。钉10030能够使得当钉10030处于其未击发位置时，钉腿10032的顶端或钉腿10032的至少某部分延伸到支撑部分10010的平台表面10011上方。在这种情况下，当钉10030处于其未击发位置时，钉腿10032可延伸到进入并被嵌入到组织厚度补偿件10020中。例如，钉腿10032可例如延伸到平台表面10011上方大约0.075"。钉腿10032可例如延伸到平台表面10011上方大约0.025"和大约0.125"之间的距离。对上文进行进一步描述，组织厚度补偿件10020可包括例如大约0.08"和大约0.125"之间的未压缩厚度。
在使用中，对上文进行进一步描述并首先参见图31，砧座诸如砧座10060例如可运动到与钉仓10000相对的闭合位置。如下文更详细所述，砧座10060可将组织抵靠组织厚度补偿件10020定位以及例如将组织厚度补偿件10020压向支撑部分10010的平台表面10011。一旦砧座10060已被恰当定位，则可部署钉10030，同样如图31所示。任选地，如上所述，钉击发滑动件10050可从钉仓10000的近侧末端10001向远侧末端10002移动，如图32所示。当滑动件10050被推进时，滑动件10050可接触钉驱动器10040并在钉腔10012内将钉驱动器10040向上抬起。滑动件10050和钉驱动器10040可各自包括一个或多个斜坡或斜面，该一个或多个斜坡或斜面可协作以使钉驱动器10040从其未击发位置向上运动。例如，参见图19-图23，每个钉驱动器10040可包括至少一个斜面10042，并且滑动件10050可包括一个或多个斜面10052，其能够使得当滑动件10050在钉仓内朝远侧被推进时，斜面10052在斜面10042下滑动。当钉驱动器10040在其各自的钉腔10012内被向上抬起时，钉驱动器10040可将钉10030向上抬起，使得钉10030可通过钉平台10011中的开口从其钉腔10012中露出。在示例性击发序列期间，首先参见图25-图27，滑动件10050可首先接触钉10030a并且开始将钉10030a向上抬起。当滑动件10050朝远侧被进一步推进时，滑动件10050可开始将钉10030b,10030c,10030d,10030e和10030f以及任何其他后续钉按顺序抬起。如图27所示，滑动件10050可将钉10030向上驱动，使得与相对的砧座接触的钉的腿10032变形至期望的形状，并且从支撑部分10010被射出。在各种情况下，作为击发序列的一部分，滑动件10030可同时将多个钉向上运动。参照图27所示的击发序列，钉10030a和10030b已运动至其完全击发位置并且从支撑部分10010被射出，钉10030c和10030d处于被击发的过程中并且被至少部分地容纳在支撑部分10010内，并且钉10030e和10030f仍然处于其未击发位置。
如上所述并参见图33，当钉10030处于其未击发位置时，钉10030的钉腿10032可延伸到支撑部分10010的平台表面10011上方。进一步参照图27所示的击发序列，钉10030e和10030f示出为处于其未击发位置，并且其钉腿10032延伸到平台表面10011上方并且延伸到组织厚度补偿件10020中。当钉10030处于其未击发位置时，钉腿10032的顶端或钉腿10032的任何其他部分可能不凸穿组织厚度补偿件10020的顶部组织接触表面10021。如图27所示，当钉10030从其未击发位置运动到其击发位置时，钉腿的末端可凸穿组织接触表面10032。钉腿10032的顶端可包括能够切割和穿透组织厚度补偿件10020的锋利的顶端。组织厚度补偿件10020可包括多个孔，所述多个孔能够接收钉腿10032并且允许钉腿10032相对于组织厚度补偿件10020滑动。支撑部分10010还可包括从平台表面10011延伸的多个导向器10013。导向器10013可被定位成邻近平台表面10011的钉腔开口，使得钉腿10032可至少部分地由导向器10013支撑。导向器10013可被定位在钉腔开口的近侧末端和/或远侧末端处。根据本发明，第一导向器10013可被定位在每个钉腔开口的第一末端，并且第二导向器10013可被定位在每个钉腔开口的第二末端，使得每个第一导向器10013可支撑钉10030的第一钉腿10032，并且每个第二导向器10013可支撑钉的第二钉腿10032。参见图33，每个导向器10013可包括沟槽或狭槽，诸如沟槽10016，例如钉腿10032可被滑动地接收在该沟槽10016中。任选地，每个导向器10013可包括可从平台表面10011延伸并可延伸到组织厚度补偿件10020中的防滑钉、突起、和/或长钉。如下文更详细所述，防滑钉、突起、和/或长钉可减小组织厚度补偿件10020和支撑部分10010之间的相对运动。钉腿10032的顶端可被定位在导向器10013中并且当钉10030处于其未击发位置时可不延伸到导向器10013的顶部表面上方。例如，导向器10013可限定导向高度，并且当钉10030处于其未击发位置时可不延伸到该导向高度上方。
根据本发明，组织厚度补偿件(诸如组织厚度补偿件10020)例如可由单个材料片构成。组织厚度补偿件可包括连续材料片，该连续材料片可覆盖支撑部分10010的整个顶部平台表面10011，或作为另外一种选择，覆盖小于整个平台表面10011。材料片可覆盖支撑部分10010中的钉腔开口，然而作为另外一种选择，材料片可包括可与钉腔开口对齐的或至少部分对齐的开口。根据本发明，组织厚度补偿件可由例如多个材料层构成。现在参见图15，组织厚度补偿件可包括可压缩芯和围绕可压缩芯的包裹物。包裹物10022能够将可压缩芯可释放地保持到支撑部分10010。例如，支撑部分10010可包括例如从其延伸的一个或多个突出部，诸如突出部10014(图18)，该突出部可接收在一个或多个孔和/或狭槽内，诸如限定在包裹物10022中的孔10024内。突出部10014和孔10024能够使得突出部10014可将包裹物10022保持到支撑部分10010。突出部10014的端部可例如通过热熔处理而变形，以便扩大突出部10014的端部，并且因此限制包裹物10022和支撑部分10010之间的相对运动。包裹物10022可包括一个或多个穿孔10025，其可有利于将包裹物10022从支撑部分10010释放，如图15所示。现在参见图24，组织厚度补偿件可包括包裹物10222，该包裹物包括多个孔10223，其中孔10223可与支撑部分10010中的钉腔开口对齐或至少部分对齐。组织厚度补偿件的芯还可包括与包裹物10222中的孔10223对齐或至少部分对齐的孔。作为另外一种选择，组织厚度补偿件的芯可包括连续主体并且可延伸到孔10223的下面，使得连续主体覆盖平台表面10011中的钉腔开口。
任选地，如上所述，组织厚度补偿件可包括用于将可压缩芯可释放地保持到支撑部分10010的包裹物。例如，参见图16，钉仓还可包括保持器夹具10026，该保持器夹具能够抑制包裹物和可压缩芯过早地与支撑部分10010分离。任选地，每个保持器夹具10026可包括能够接收从支撑部分10010延伸的突出部10014的孔10028，使得保持器夹具10026可被保持到支撑部分10010。保持器夹具10026可各自包括至少一个平底部分10027，该平底部分可延伸到支撑部分10010的下面并在支撑部分10010内支撑并保持钉驱动器10040。如上所述，组织厚度补偿件可通过钉10030可移除地附接至支撑部分10010。更具体地讲，还如上所述，当钉10030处于其未击发位置时，钉10030的腿可延伸到组织厚度补偿件10020中，并因此将组织厚度补偿件10020可释放地保持到支撑部分10010。钉10030的腿可与其相应的钉腔10012的侧壁接触，其中，由于钉腿10032和侧壁之间的摩擦，钉10030和组织厚度补偿件10020可被保持在适当位置，直到钉10030从钉仓10000被部署。当钉10030被部署后，组织厚度补偿件10020可被捕获在钉10030内并且抵靠缝合的组织T被保持。当砧座随后运动到打开位置以释放组织T时，支撑部分10010可运动远离已固定至组织的组织厚度补偿件10020。可使用粘合剂以可移除地将组织厚度补偿件10020保持到支撑部分10010。可使用两部分粘合剂，其中，粘合剂的第一部分可被放置到平台表面10011上，并且粘合剂的第二部分可被放置到组织厚度补偿件10020上，使得当组织厚度补偿件10020紧贴平台表面10011放置时，第一部分可接触第二部分以启用粘合剂并将组织厚度补偿件10020可分离地粘结至支撑部分10010。任选地，可使用任何其他合适的方法将组织厚度补偿件可分离地保持到钉仓的支撑部分。
对上文进行进一步描述，滑动件10050可从近侧末端10001被推进到远侧末端10002以完全部署被容纳在钉仓10000内的所有钉10030。现在参见图56-图60，滑动件10050可在支撑部分10010内的纵向腔体10016中由击发构件或外科缝合器的刀杆10052朝远侧推进。在使用中，钉仓10000可被插入外科缝合器的钳口中的钉仓通道内，例如钉仓通道10070内，并且击发构件10052可被推进到与滑动件10050接触，如图56所示。当滑动件10050由击发构件10052朝远侧推进时，滑动件10050可接触最近侧的钉驱动器或驱动器10040，并且将钉10030从仓体10010击发或射出，如上所述。如图56所示，击发构件10052还可包括切割刃10053，当钉10030被击发时，该切割刃可通过支撑部分10010中的刀狭槽朝远侧被推进。根据本发明，相应的刀狭槽可延伸穿过被定位在钉仓10000对面的砧座，使得切割刃10053可在砧座和支撑部分10010之间延伸并切割被定位在其间的组织和组织厚度补偿件。在各种情况下，滑动件10050可由击发构件10052朝远侧推进，直到滑动件10050到达钉仓10000的远侧末端10002，如图58所示。此时，击发构件10052可朝近侧回缩。滑动件10050可随击发构件10052朝近侧回缩，但是现在参见图59，当击发构件10052回缩时，滑动件10050可被留在钉仓10000的远侧末端10002中。一旦击发构件10052已充分回缩，砧座可被再次打开，组织厚度补偿件10020可与支撑部分10010分离，并且已耗尽钉仓10000的剩余的非植入部分，包括支撑部分10010，可从钉仓通道10070中被移除。
当已耗尽钉仓10000已从钉仓通道中被移除后，对上文进行进一步描述，新的钉仓10000或任何其他合适的钉仓可被插入钉仓通道10070中。对上文进行进一步描述，钉仓通道10070、击发构件10052、和/或钉仓10000可包括协作结构，该协作结构可在新的未击发钉仓10000没有被定位在钉仓通道10070中时防止击发构件10052再次或随后朝远侧被推进。更具体地讲，再次参见图56，当击发构件10052被推进到与滑动件10050接触时，并且当滑动件10050处于其近侧未击发位置时，击发构件10052的支撑鼻部10055可被定位在滑动件10050上的支撑凸缘10056上和/或之上，使得击发构件10052被保持在足够向上的位置，以防止从击发构件10052延伸的锁或横梁10054落入被限定在钉仓通道内的锁凹槽中。由于锁10054不会落入锁凹槽时，在此类情况下，当击发构件10052被推进时，锁10054可不邻接锁凹槽的远侧侧壁10057。当击发构件10052将滑动件10050朝远侧推动时，击发构件10052可由于靠在支撑凸缘10056上的支撑鼻部10055而被支撑在其向上击发位置。当击发构件10052相对于滑动件10050回缩时，如上所述并如图59所示，当支撑鼻部10055不再靠在滑动件10050的支撑凸缘10056上时，击发构件10052可从其向上位置下落。例如，外科钉可包括能够将击发构件10052偏置到其向下位置的弹簧10058和/或任何其他合适的偏置元件。一旦击发构件10052已完全回缩，如图60所示，击发构件10052不能再次穿过用尽的钉仓10000朝远侧被推进。更具体地讲，当此时处于操作顺序的滑动件10050已被留在钉仓10000的远侧末端10002处时，击发构件10052不能被滑动件10050保持在其上部位置。因此，如上所述，如果击发构件10052在没有替换钉仓的情况下被再次推进，则锁横梁10054将接触锁凹槽的侧壁10057，这将防止击发构件10052再次朝远侧被推进到钉仓10000中。换句话讲，一旦用尽的钉仓10000已被新的钉仓替换，新的钉仓将具有近侧定位的滑动件10050，该近侧定位的滑动件可将击发构件10052保持在其向上位置，并且使击发构件10052再次朝远侧被推进。
如上所述，滑动件10050能够将钉驱动器10040在第一未击发位置和第二击发位置之间运动，以便将钉10030从支撑部分10010中射出。在钉10030已从支撑部分10010被射出以后，钉驱动器10040可被容纳在钉腔10012内。支撑部分10010可包括能够阻止钉驱动器10040从钉腔10012中射出或掉出的一个或多个保持结构。作为另外一种选择，滑动件10050能够将钉驱动器10040从具有钉10030的支撑部分10010中射出。例如，钉驱动器10040可由例如可生物吸收的和/或生物相容性材料构成，诸如聚醚酰亚胺(Ultem)。钉驱动器可附接到钉10030。例如，钉驱动器可被模塑在每个钉10030的基部之上和/或周围，使得驱动器与钉一体形成。2006年9月29日提交的名称为“SURGICAL STAPLES HAVING COMPRESSIBLE ORCRUSHABLE MEMBERS FOR SECURING TISSUE THEREIN ANDSTAPLING INSTRUMENTS FOR DEPLOYING THE SAME”美国专利申请序列号11/541,123全文以引用方式并入本文。
如上所述，外科缝合器械可包括能够接收钉仓的钉仓通道、可旋转地联接到钉仓通道的砧座、和包括刀刃的击发构件，该击发构件可相对于砧座和钉仓通道运动。在使用中，钉仓可被定位在钉仓通道内，并且当钉仓被至少部分地消耗后，钉仓可从钉仓通道移除并被新的钉仓替换。例如，外科缝合器械的钉仓通道、砧座、和/或击发构件可与替换钉仓一起被重复使用。作为另外一种选择，钉仓可包括部分一次性加载单元组件，该一次性加载单元组件例如可包括钉仓通道、砧座、和/或击发构件，这些可作为替换一次性加载单元组件的一部分随钉仓一起被替换。某些一次性加载单元组件公开于2008年2月15日提交的名称为“END EFFECTOR COUPLINGARRANGEMENTS FOR A SURGICAL CUTTING AND STAPLINGINSTRUMENT”的美国专利申请序列号12/031,817中，该专利申请的全部公开内容以引用方式并入本文。
组织厚度补偿件可包括可挤出、可浇铸和/或可模塑的组合物，其包括本文所述的合成材料和/或非合成材料中的至少一种。组织厚度补偿件可包括具有两层或更多层的膜或片。组织厚度补偿件可使用常规方法获得，例如混合、共混、组合、喷涂、芯吸、溶剂蒸发、浸渍、刷涂、气相沉淀、挤出、压延、浇铸、模塑等等。挤出时，开口可以包括至少一个开口的模具的形式为露出的挤出物赋予形状。压延时，开口可包括两个辊之间的辊隙。常规的模塑方法可包括但不限于吹塑、注塑、泡沫注射、压塑、热成形、挤出、发泡挤出、薄膜吹塑、压延、旋压、溶剂熔接，涂布方法诸如浸涂和旋涂、溶液流延和薄膜铸塑、增塑溶胶加工(包括刮刀涂布、辊涂和浇铸)，以及它们的组合。注塑时，开口可包括喷嘴和/或通道/流道和/或模具腔体和特征结构。压塑时，组合物可定位在模具腔体内，加热到合适的温度，并通过在相对高压下受到压缩而成形。浇铸时，组合物可包含液体或浆液，其注入或换句话讲提供到模具或物体的里面、上面和/或周围，以复制模具或物体的特征结构。浇铸后，组合物可被干燥、冷却和/或固化以形成固体。
根据本发明，制造包括至少一种保存和/或吸收于其中的药物的组织厚度补偿件的方法可大体包括提供组织厚度补偿件，以及使组织厚度补偿件和药物接触以将药物保留在组织厚度补偿件中。制造包含抗菌剂材料的组织厚度补偿件的方法可包括提供水凝胶、干燥水凝胶、在硝酸银水溶液中溶胀水凝胶、使水凝胶和氯化钠溶液接触，以形成具有抗菌特性的组织厚度补偿件。组织厚度补偿件可包括分散在其中的银。
现在参见图116，组织厚度补偿件(例如，组织厚度补偿件22020)可例如附接到外科缝合器械的砧座(例如，砧座22060)。组织厚度补偿件22020可包括限定在第一膜22026和第二膜22027之间的腔体22024，其中第一膜22026的至少部分附接到第二膜22027。例如，第一膜22026可沿着例如横向接缝22028a和横向接缝22028b附接到第二膜22027。第一膜22026可沿密封的周边附接到第二膜22027，以便密封地包封腔体22024。第一膜22026和第二膜22027可例如沿横向接缝22028a、22028b和/或连接膜22026和膜22027的任何其他接缝来进行热焊接。再次参见图116，砧座22060可包括多个钉成形凹坑22062，所述多个钉成形凹坑22062各自能够接收钉的腿并且使其变形，其中第二膜22027可包括可延伸到成形凹坑22062内的突出部22022。突出部22022的尺寸和构造可设定成使其紧密地配合在成形凹坑22062内并且能够将组织厚度补偿件22020保持到砧座22060。如图所示，砧座22060可包括例如六行成形凹坑22062，其中组织厚度补偿件22020可类似地包括与成形凹坑22062对齐的六行突出部22022。可使用包括多于或少于六行成形凹坑22062和/或突出部22022的其他实施例。可使用一种或多种粘合剂来将组织厚度补偿件22020保持到砧座20060。
如上所述，组织厚度补偿件22020可包括限定于其中的腔体22024。腔体22024可沿着砧座22060纵向延伸。再次参见图116，组织厚度补偿件22020可包括定位在腔体22024内的可压缩材料。现在参见图117，钉(例如钉22030)可例如从钉仓射出，以使得钉22030在接触砧座22060之前穿透组织T并且随后穿透组织厚度补偿件22020。当钉22030的腿通过砧座22060进行变形时，腿可向下翻转，以再次穿透组织厚度补偿件22020。在任何情况下，一旦钉22030已穿透组织厚度补偿件22020，容纳在腔体22024内的一种或多种流体就例如可从组织厚度补偿件22020流出或渗出到组织T上。腔体22024可包括例如容纳于其中的一种或多种粉末，所述粉末在组织厚度补偿件22020一旦已被钉22030至少部分地破裂就可逸出腔体22024。根据本发明，定位在腔体内的材料22025可在钉22030变形成其击发构型时被压缩或挤压在钉22030内，以使得储存在材料22025内的流体可例如从材料22025压出。再次参见图117，钉22030还能够捕获组织厚度补偿件(例如，补偿件22029)，所述补偿件例如可移除地附接到紧靠组织T的另一侧的钉仓。
对上文进行进一步描述，材料22025可包括例如冷冻干燥的凝血酶、冷冻干燥的血纤维蛋白、和/或细纤维非织造氧化再生纤维素。材料22025可包括压缩的粉末晶片。密封腔体22024可包括内部气体，所述内部气体的压力低于围绕组织厚度补偿件22020的大气的压力。在这种情况下，内部腔体22024中的气体与大气之间的压差可导致膜22027和膜22028被向内拖曳。当内部腔体22024被钉22030破裂之后，如上所述，内部腔体22024内的真空可与周围大气取得平衡并且材料22025可逸出内部腔体22024，另外如上所述。在此类情况下，组织厚度补偿件22020可向捕获在钉20030内的组织T扩展并施加压缩力。在材料22025被真空封装在组织厚度补偿件22020内的情况下，材料22025可在内部腔体22024已被刺穿之后扩展。膜22026、22027可由可生物吸收性材料构成，并且能够在一旦放置在患者内时就溶解。每个膜22026、22027可由层或层合体构成，所述层或层合体具有例如介于大约0.25密耳和大约0.50密耳之间的厚度。在任何情况下，对上文进行进一步描述，当钉22030从其钉仓击发时，包括材料22025的组织厚度补偿件22020可被切割元件横切。
再次参见图116，组织厚度补偿件22020的腔体22024和材料22025可被定位在钉成形凹坑22062的四个内侧行下面，而接缝22028a、22028b可被定位在成形凹坑22062的外侧行下面。在这种情况下，外侧钉行中的钉可不接合材料22025，并且因此它们可在其中不捕获材料22025。相反，此类钉可仅沿着接缝22028a、22028b来捕获膜22026和膜22027。作为另外一种选择，现在参见图118和图119，组织厚度补偿件22120可按照类似于上文的方式包括第一膜22126、第二膜22127、以及捕获在第一膜22126和第二膜22127之间的多个材料22125a-d。例如，主要参见图118，第一材料22125a可与钉仓22000中的钉22030的外侧行和砧座22060中的钉腔22062的外侧行对齐，第二材料22125b和第三材料22125c可各自与钉22030和钉腔22062的两个内侧行对齐，并且第四材料22126d可与钉22030和钉腔22062的另一个外侧行对齐。在这种情况下，现在参见图119，钉22030中的全部可被布置成使其可在其中捕获材料22125a-22125d中的至少一者。如图118和图119所示，对上文进行进一步描述，钉22030可在未击发位置和击发位置之间通过定位在钉仓22000内的钉驱动器22040来向上提升。
再次参见图118和图119，层22126和层22127可限定其中可设置材料22125a-d的一个或多个密封腔体。层22126和层22127可沿着周边例如利用任何合适的方法(例如，热焊接和/或激光焊接)密封在一起，所述周边可包括横向接缝22128a和横向接缝22128b。材料22125a-22125d中的每一者可密封在单独腔体内，而作为另外一种选择，材料22125a-22125d中的两者或更多者可密封在同一腔体内。材料22125a-22125d可由相同的材料构成，而作为另外一种选择，材料22125a-22125d中的一者或多者可由不同的材料构成。材料22125a-22125d中的一者或多者可由例如硬脂酸钠和/或LAE构成。材料22125a-22125d可包括润滑剂。在此类情况下，当钉腿穿透组织厚度补偿件22120的材料22125a-22125d时，可使钉22030的腿暴露于润滑剂。在腿穿过组织厚度补偿件22120之后，腿可接触砧座22060，其中润滑剂可降低钉腿与砧座22060之间的摩擦系数和摩擦力。在此类情况下，可降低击发钉22030所需的力。由于组织厚度补偿件22120紧靠砧座22060的定位，钉22030的钉腿可在离开组织厚度补偿件22120之后直接接触砧座22060，由此降低了在钉腿接触砧座22060之前可从钉腿擦掉润滑剂的可能性。相似地，钉22030的钉腿可在暴露于组织厚度补偿件22120内的一种或多种药物之后直接接触砧座22060，由此降低了在钉腿重新进入组织T之前可从钉腿擦掉药物的可能性。在一些情况下，当钉腿向下变形时，钉腿可重新进入组织厚度补偿件22120，以使得钉腿可例如在重新进入组织T之前重新暴露于药物。任选地，与上文相似，第二膜22127可包括例如可紧密地接收在钉腔22062内的多个突出部22122，以便例如将组织厚度补偿件22120保持到砧座22060。
现在参见图120和图121，外科缝合器械的端部执行器可包括组织厚度补偿件(例如，补偿件22220)，所组织厚度补偿件可例如包括与砧座22060的钉成形凹坑22062对齐的多个腔体22222。补偿件22220可由第一层或底层22226和第二层或顶层22227构成，其中第一层22226和/或第二层22227可包括可限定腔体22222的多个凸起部分或局部气泡。如图120所示，补偿件22220可附接到砧座22060，以使得腔体22222与砧座22060的钉成形凹坑22062对齐或至少基本上对齐。任选地，每个腔体22222可包括容纳于其中的一种或多种药物，例如，氧化再生纤维素、钙、和/或藻酸盐。在使用期间，每个腔体22222可在例如由从钉仓22000射出的钉22030刺穿之前处于密封、未刺穿状态。现在参见图121，在钉22030的腿已穿过组织T之后，每个钉腿可刺穿和穿透第一层22226并且进入腔体22222，其中钉腿随后可在刺穿和穿透第二层22227之前穿过容纳于其中的一种或多种药物。与上文相似，钉22030的腿可随后接触砧座22060。
腔体22222可在破裂之前保持储存于其中的一种或多种药物处于干燥状态或至少基本上干燥的状态。在腔体22222已破裂之后，流体(例如，血液)可进入腔体22222并且与一种或多种药物混合。流体与药物的混合物可导致药物在腔体22222内膨胀，其中例如药物可包括例如至少一种水凝胶。药物可包括例如至少一种止血材料。第一层22226和/或第二层22227可由柔性材料构成，所述柔性材料可拉伸以适应药物的膨胀。层22226、22227可由例如CAP/GLY材料构成。在任何情况下，药物的膨胀可例如对捕获在钉22030内和/或定位在钉22030周围的组织施加压缩力。在各种情况下，药物的膨胀可导致腔体22222破裂。例如，第一组腔体22222可在其中包括第一药物，而第二组腔体22222可在其中包括第二药物。例如，第一药物能够膨胀第一量和/或以第一速率膨胀，而第二药物能够膨胀第二量和/或以第二速率膨胀，例如，其中第一量可不同于第二量并且/或者第一速率可不同于第二速率。对上文进行进一步描述，一个或多个腔体22222可包括储存在每个腔体中的一种或多种药物，其中药物可包括例如第一药物和第二药物。腔体22222可在破裂之前保持第一药物和第二药物处于干燥状态或至少基本上干燥的状态。如上所述，在腔体22222已破裂之后，血液例如可进入腔体22222内并且与第一药物和第二药物混合，其中第一药物和第二药物可形成膨胀的凝胶。
现在参见图122-124，组织厚度补偿件(例如，补偿件22320)可包括可分别与钉成形凹坑22062a和钉成形凹坑22062b对齐的多个第一腔体22322a和多个第二腔体22322b。主要参见图123，钉成形凹坑22062a和钉成形凹坑22062b可限定在砧座22060上的单独阶梯表面中。更具体地讲，例如，成形凹坑22062a可限定在砧座22060的第一表面22069a中，并且成形凹坑22062b可限定在第二表面22069b中，其中第一表面22069a可被定位成偏离或高于第二表面22069b组织厚度补偿件22320的第一腔体22322a可大于第二腔体22322b，其中例如第一腔体22322a可高于第二腔体22322b而延伸。由于上文所述，第一腔体22322a可向上延伸到第一钉成形凹坑22062a中，同时第二腔体22322可向上延伸到第二钉成形凹坑22062b中。任选地，每个第一腔体22322a能够例如比第二腔体22322b包含更大的药物量。作为另外一种选择，第一腔体22322a和第二腔体22322b可在其中包含相同或至少基本上相同的药物量，即使腔体22322a和腔体22322b可具有不同的尺寸。
对上文进行进一步描述，第一腔体22322a可被布置在特定行中，而第二腔体22322b可被布置在不同行中。组织厚度补偿件可包括与每个成形凹坑对齐的腔体，而作为另外一种选择，参见图130，组织厚度补偿件(例如，补偿件22420)例如可包括与成形凹坑中的仅一些对齐的腔体。再次参见图123，补偿件22320可附接到砧座22060。腔体22322a和/或腔体22322b可被构造成使其分别紧密地配合在钉成形凹坑22062a和/或钉成形凹坑22062b内。补偿件22320可被组装到砧座22060，以使得补偿件22320的第二层22327被定位成紧靠砧座22060的第二表面22069b。作为另外一种选择，现在参见图125和126，补偿件22320可被定位成邻近砧座22060，以使得当砧座22060朝钉仓22000移动以将组织T压缩在其间时，补偿件22320可邻接砧座22060。现在参见图127，一旦钉22030已从钉仓22000击发并且通过砧座22060进行变形，补偿件22320就可紧靠组织T被钉22030捕获并且砧座22060就可移动远离补偿件22320。在某些情况下，现在参见图128，钉22030中的一个或多个可未通过砧座22030得到正确地变形。在此类情况下，现在参见图129，当钉被击发时，覆在未击发或未成形的钉上面的组织厚度补偿件中的腔体可未被刺穿。例如，组织厚度补偿件可由可生物吸收性材料构成，所述可生物吸收性材料可溶解并随后释放容纳在未刺穿腔体中的药物。
对上文进行进一步描述，组织厚度补偿件22320的第一腔体22322a和/或第二腔体22322b可包括例如密封在其中的气体，例如，空气、二氧化碳、和/或氮气。腔体22322a和/或腔体22322b可包括气泡，所述气泡可在钉22030击发穿过腔体22322a和/或腔体22322b时爆裂，以释放容纳在其中的气体。这种爆裂可为正在使腔体22322a和腔体22322b破裂的外科医生提供声音反馈。然而，在一些情况下，一些钉22030可为未击发的，如上所述，并且与其相关联的腔体22322a和腔体22322b可未被爆裂。在各种情况下，外科医生可对缝合的组织扫描任何未爆裂的气泡、或腔体22322a和腔体22322b，并且确定是否需要采取任何纠正措施。
如上所述，现在参见图131，外科缝合器械可包括击发构件，例如，击发构件22080，所述击发构件22080可包括切割构件或切割刃22081，所述切割构件或切割刃22081可在击发构件22080推进穿过仓22000以从其部署钉22030时推进穿过组织T和一个或多个组织厚度补偿件。主要参见图133，补偿件(例如，补偿件22520)可附接到外科缝合器械的砧座22060，其中砧座22060可包括尺寸和构造设定成接收切割构件22081的至少一部分的刀狭槽22061。相似地，钉仓22000可包括尺寸和构造也可设定成接收切割构件22081的至少一部分的刀狭槽22011。再次参见图131，补偿件22520可包括例如沿补偿件22520的切割线22521定位的一个或多个腔体，例如，腔体22522，其中腔体22522可与限定在砧座22060中的刀狭槽22061对齐。当切割构件22081朝远侧行进穿过钉仓22000以部署钉22030时，切割构件22081可切割组织T和补偿件22520的腔体22522。与上文相似，主要参见图132，每个腔体22522可限定密封的腔体22524，所述密封的腔体22524可在其中包含一种或多种药物22525。腔体22522中的一个或多个能够包含流体，所述流体可在腔体22522被切割构件22081至少部分地切割时释放。在各种情况下，切割构件22081可连续地切割腔体22522，并且因此可连续地释放包含于其中的药物。
主要参见图133，补偿件22520可包括沿其侧面延伸的横向突出部或翼部22529。突出部22529可利用例如一种或多种粘合剂固定到砧座表面22069a和/或砧座表面22069b。突出部22522的尺寸和构造可设定成紧密地配合在砧座22060的刀狭槽22061内，以使得例如突出部22522可将补偿件22520保持到砧座22060。横向突出部22529的尺寸和构造可设定成使其延伸到或覆在钉成形凹坑22062b和/或钉成形凹坑22062a上。作为另外一种选择，现在参见图134和图135，补偿件22620可包括横向突出部22629，所述横向突出部22629并未延伸到或覆在例如砧座22060的钉成形凹坑22062a和22062b和/或任何其他钉成形凹坑上。例如，补偿件22620可未被捕获在从钉仓22030射出的钉22030内。在任何情况下，再次参见图131，切割构件22081可在补偿件22520被钉22030固定到组织T时横切补偿件22520。在此类情况下，补偿件22520可与砧座22060分离并且与组织T保持在一起。再次参见图134和图135所示的补偿件22620，钉22030可未将补偿件22620固定到砧座22060，并且可在切割构件22081已横切补偿件22620之后将补偿件保持附接到砧座22060。
现在参见图136和图137，外科缝合器械的端部执行器可包括组织厚度补偿件，例如补偿件22720，所述补偿件22720可附接到或者能够附接到砧座，例如砧座22760等等。与上文相似，砧座22760可包括多个钉成形凹坑22762和纵向刀狭槽22761，在切割构件推进穿过端部执行器时，所述纵向刀狭槽22761中能够接收切割构件。补偿件22720可包括可彼此附接以限定腔体22724的第一膜层22726和第二膜层22727。例如，第一膜层22726可沿密封的外周边22728附接到第二膜层22727，其中密封的外周边22728可例如容纳腔体22724中的至少一种药物22725。如图137所示，腔体22724和药物22725可在全部钉腔22762下方延伸，并且密封的周边22728可相对于最外侧钉腔22762横向地定位。补偿件22720还可包括例如纵向肋22721，所述纵向肋22721能够向上延伸到刀狭槽22761内。例如，肋22721的尺寸和构造可设定成紧密地配合在刀狭槽22761内，以便将补偿件22720固定到砧座22760。肋22721能够使补偿件22720与砧座22760对齐或中心对准。相似地，参见图138，组织厚度补偿件22820可包括保持肋22821，所述保持肋22821可例如被定位在刀狭槽22761内，以便将补偿件22820固定到砧座22760。再次参见图137，在各种情况下，当切割构件推进穿过刀狭槽22761时，切割构件可横切肋22721并且使补偿件22720从砧座22760释放。例如，这种切割构件在图138中示为击发构件22080的一部分。
再次参见图138，组织厚度补偿件22820可包括第一层22826和第二层22827，所述第一层22826和第二层22827可被构造和布置成限定多个第一封包22824a和多个第二封包22824b。第一封包22824a中的每一个能够包含第一药物，并且第二封包22824b中的每一个能够包含第二药物，其中第二药物可不同于第一药物。第一封包22824a和第二封包22824b可以交替布置方式布置。例如，第一封包22824a和第二封包22824b可横向地延伸横跨组织厚度补偿件22820，以使得例如第二封包22824b定位在两个第一封包22824a中间并且第一封包22824a定位在两个第二封包22824b中间。当切割构件22080行进穿过补偿件22820时，如图138所示，切割构件22080可横切第一封包22824a，之后是第二封包22824b，之后是第一封包22824a，之后是第二封包22824b等等。相应地，在此类情况下，例如，切割构件22080可以交替布置方式连续地释放例如容纳在第一封包22824a中的第一药物和容纳在第二封包22824b中的第二药物。在第一封包22824a和第二封包22824b被定位成彼此相邻的情况下，当第一药物和第二药物从其相应的第一封包22824a和第二封包22824b释放时，第一药物能够与第二药物混合。例如，切割构件穿过补偿件22820的推进可使得第一药物与第二药物混合。
对上文进行进一步描述，第一药物可包括第一粉末，而第二药物可包括第二粉末。第一药物和/或第二药物可由例如止血材料、氧化再生纤维素、藻酸盐、和/或钙构成。第一药物和/或第二药物可包括流体。第一封包22824a中的一个或多个和/或第二封包22824b中的一个或多个可包括润滑剂，所述润滑剂可减小推进击发构件22080穿过补偿件22820和/或组织T所需的力。第一膜层22826和/或第二膜层22827可由例如可生物吸收材料(例如PDS)构成。第一膜层22826和第二膜层22827可彼此附接，以使得第一封包22824a在被击发构件22080切割之前与第二封包22824b密封隔离。第一封包22824a和/或第二封包22825b可具有一定的破裂强度，以便耐受一定的破裂压力。更具体地讲，当砧座(例如，砧座22760)朝着背对砧座22760定位的钉仓移动补偿件22820时，封包22824a、封包22824b可被定位成紧靠设置在封包22824a、封包22824b与钉仓中间的组织，其中砧座22760可随后向下朝钉仓推压或夹紧，以便压缩定位在其间的组织。在此类情况下，封包22824a、封包22824b可经受压缩压力。在一些情况下，期望封包22824a和/或封包22824b保持完整，直至它们被切割构件22080切割和/或由从钉仓击发的钉刺穿。在某些其他情况下，期望封包22824a和/或封包22824b因施加到其的压缩夹紧负荷而破裂。
如上所述，第一封包22824a和第二封包22842b可横向地延伸横跨补偿件22820。例如，第一封包22824a可沿着横向轴线22823a延伸，而第二封包22824b可沿着横向轴线22823b延伸。第一轴线22823a和/或第二轴线22823b可垂直于、或至少基本上垂直于补偿件22820的纵向轴线22083。例如，纵向轴线22083可限定击发构件22080的切割路径。第一轴线22823a和/或第二轴线22823b可不垂直于纵向轴线22083并且可相对于纵向轴线22083倾斜。任选地，如上所述，第一封包22824a和第二封包22824b可以交替布置方式布置。作为另外一种选择，可使用第一封包22824a和第二封包22824b的任何其他合适的构型。例如，布置在组织厚度补偿件中的封包序列可包括第一封包22824a、第二封包22824b、第二封包22824b、和第一封包22824a。组织厚度补偿件还可包括多个第三封包，所述第三封包包括不同于第一药物和第二药物的第三药物。例如，第一封包、第二封包、和第三封包可以交替布置方式布置。例如，布置在组织厚度补偿件中的封包序列可包括例如第一封包、之后是第二封包、之后是第三封包。
再次参见图138，组织厚度补偿件22820的第一封包22824a和/或第二封包22824b可限定例如U形的、或至少基本上U形的横截面。现在参见图139，组织厚度补偿件22920的封包22924可限定例如圆形的、或至少基本上圆形的横截面。现在参见图140，组织厚度补偿件23020的封包23024可限定例如卵圆形的和/或椭圆形的横截面。再次参见图138，第一腔体22824a和第二腔体22824b可包括限定在平行的或至少基本上平行的行中的对称的或至少几乎对称的构型。作为另外一种选择，现在参见图141，组织厚度补偿件(例如，补偿件23120)可包括限定在其中的非对称腔体23122，所述非对称腔体23122可具有例如不规则的和/或非重复的图案。例如，腔体23122中的每一个可在其中包含一种或多种不同的药物。
现在参见图142，组织厚度补偿件(例如，组织厚度补偿件23220)可包括壳体23226，所述壳体23226限定其中的腔体23224和定位在腔体23224内的材料23225。壳体23226可由例如可吸收聚合物、PDS、PGA、PLLA、Cap Gly、和/或PCL构成，而材料23225可由例如止血剂、氧化再生纤维素、Hercules、血纤维蛋白、和/或凝血酶构成，所述材料23225可采用任何合适的形式，例如粉末、纤维、和/或凝胶。可利用挤出工艺来制造壳体23226。在此类情况下，壳体23226可包括沿其长度恒定的或至少基本上恒定的横截面，所述壳体23226可在不必焊接有接缝的情况下来产生。例如，腔体23224可由围绕其整个周边延伸的侧壁限定，所述侧壁不具有限定于其中的开口。壳体23226可由具有限定于其中的开口的网片和/或稻草状材料构成。可在壳体23226中通过例如激光切割工艺和/或冲切工艺来切割开口。
作为制造材料23225的一部分，现在参见图145-147，股纱可利用纤维和/或纤维材料(例如，氧化再生纤维素)来形成。可将图145所示的较长纤维23325和图146所示的较短纤维23425按照图147所示的方式混合在一起，以形成材料23225的股纱。股纱可在张力下进行拉延和/或可设置在张力下，以便沿纵向方向来拉伸包含于其中的纤维。现在参见图148，材料23225的股纱可通过抓紧器23290进行松散，所述抓紧器23290可抓紧和扭曲材料23225以增加股纱的体积。例如，当股纱正相对于例如抓紧器23290移动时，抓紧器23290可松散材料23225。再次参见图148，可例如在材料23225的股纱中利用切割构件23291来制备小切口和/或微切口。与上文相似，当股纱正相对于切割构件23291移动时，切割构件23291可切割材料23225。材料23225的股纱可在制备上述切口之前被松散，而作为另外一种选择，材料23225的股纱可在其松散之前被切割。
一旦材料23225的股纱已被合适地制备，就可将材料23225定位在壳体23226内。现在参见图149，两个或多个壳体23226可作为上述挤出工艺的一部分形成在一起，其中壳体23226可连接在一起以作为管23227的一部分。材料23225的股纱可定位在或拉延到限定于管23227中的腔体23224内。材料23225的股纱可被定位在腔体23224的第一开口端23221附近和/或内部，其中可通过腔体23224的第二开口端23222插入抓紧器23292。然后可推压抓紧器23292穿过腔体23224，直到抓紧器23292的钳口23292a穿过第一开口端23222并且/或者相对于第一开口端23222进行定位，以使得抓紧器钳口23292a可被操纵以抓紧材料23225的股纱。抓紧器可包括例如钩构件，所述钩构件能够抓紧材料23225的股纱。在任何情况下，一旦抓紧器23292已充分地抓紧材料23225的股纱，抓紧器23292就可撤回腔体23224内，以便将材料23225的股纱牵拉到腔体23224内。抓紧器23292能够在股纱被牵拉到管23227内之前、期间、和/或之后来扭曲材料23225的股纱。
一旦材料23225的股纱已合适地定位在管23227内，抓紧器23292就可随后被操纵以释放材料23225的股纱。可在股纱已被牵拉穿过管23227的第二开口端23222之前释放股纱，而作为另外一种选择，可在股纱已被牵拉穿过第二开口端23222之后释放股纱，如图150所示。在某些情况下，可将股纱牵拉穿过第二开口端23222，以使得当释放股纱时，股纱可通过第二开口端23222收缩或回弹到管23227内。在各种情况下，可在邻近第一开口端23221的位置处切割股纱，以使得股纱可通过第一开口端23222收缩或回弹到管23227内，与上文相似。在各种情况下，对上文进行进一步描述，抓紧器23292可对材料23225的股纱施加张力，以使得当抓紧器23292释放股纱和/或当股纱被切割时，股纱内的张力可被释放，从而允许股纱收缩。
现在参见图151，一旦材料23225的股纱已充分地定位在管23227内，就可将管23227和材料23225切割成多个区段，其中每个区段可被制备成例如组织厚度补偿件23220。延伸穿过每个此类区段的覆盖件23226的腔体23224可包括位于其相对末端的开口端。例如，可通过例如热铆焊、热焊接、和/或激光焊接工艺来封闭和/或密封开口端中的一者或两者。参见图152，可将包括覆盖件23226和其中的材料23225的一部分的区段定位在模具内，所述模具能够封闭和/或密封覆盖件23226的开口端。更具体地讲，模具可例如包括基座23294和可移动部分23296，其中区段可被定位在限定于基座23294中的腔体23295内。一旦被定位，可移动部分23296就可向下移动，以对区段施加力。任选地，可经由基座23294和/或可移动部分23296来对区段加热，其中施加到区段的热和/或力可使覆盖件23226变形。更具体地讲，可移动部分23296可限定凹坑23297，所述凹坑23297可为成轮廓的以对覆盖件23226的某些部分(例如其开口端)施加夹紧力，以便封闭、压平、和/或颈缩组织厚度补偿件23220的这些部分。例如，凹坑23297能够形成组织厚度补偿件23220的封闭端23228并且压平定位在封闭端23228中间的组织厚度补偿件23220部分。在组织厚度补偿件23220已合适地形成之后，可将可移动部分23296移动到打开位置并且可从模具移出组织厚度补偿件23220。然后可将组织厚度补偿件23220定位在冷却容器中，其中可允许补偿件23220冷却到室温和/或任何其他合适的温度。
作为另外一种选择，对上文进行进一步描述，可在材料23225已定位在管23227中之后来将该管定位在热成形模具内。在管23227和定位在其中的材料23225已成形之后，则可将管23227和材料23225分割成例如多个组织厚度补偿件23220。再次参见图142，组织厚度补偿件23220可包括例如能够附接到砧座22060的横向翼部或夹具23229。例如，当在模具部分23294和模具部分23296之间形成组织厚度补偿件23220时，可在覆盖件23226中形成横向翼部23229，如上所述。现在参见图143，组织厚度补偿件23320可包括从覆盖件23326延伸的横向翼部23329。现在参见图144，组织厚度补偿件23420可例如包括具有一个或多个横向挠性接合部23428的覆盖件23426，所述一个或多个横向挠性接合部23428可允许覆盖件23426当在上述热成形模具中经受压缩压力时挠曲和变平。任选地，由于上文所述，组织厚度补偿件23220可不包括横向接缝。在此类情况下，再次参见图142，材料23225可例如延伸到砧座22060的横向边缘。
如上所述，可将股纱牵拉穿过管并且随后切割成一定长度以形成一个或多个组织厚度补偿件。对上文进行进一步描述，可利用刚性材料股线来将股纱牵拉或推压穿过管。可将聚合物材料(例如PCL)的刚性股线例如加热到超过其玻璃化转变温度并且拉伸成变形的形状。例如，刚性股线可包括未变形的螺线形状，所述未变形的螺线形状在拉伸成其变形形状时可包括例如直线的或至少基本上直线的形状。然后，可将刚性股线冷却到低于玻璃化转变温度，同时约束刚性股线以使刚性股线可保持其变形形状。一旦刚性股线处于其变形的纤维中，就可例如围绕刚性股线形成股纱。ORC股纱可例如卷绕、聚集、和/或折叠在刚性股线上。作为另外一种选择，例如，可将刚性股线插入到ORC纤维内。刚性股线可包括能够卷在和/或浸在ORC纤维内的粘性表面。在任何情况下，随后可将刚性股线和ORC纤维插入到管内，与上文相似，并且再次加热到超过刚性股线的玻璃化转变温度。在此类情况下，刚性股线可为无约束的或至少基本上无约束的，并且可允许返回或至少基本上返回到其初始未变形的形状。例如，刚性股线可在返回其初始形状时收缩并且使ORC纤维回缩到管内。当刚性管收缩时，可夹紧管的中心以将刚性股线和ORC纤维保持在管的中心。与上文相似，可密封管的末端，以包封其中的刚性股线和ORC纤维。
现在参见图244，组织厚度补偿件33320可包括外壳33326、定位在外壳33326内的可压缩芯、和能够将可压缩芯容纳在外壳33326内的封闭端33328。对上文进行进一步描述，外壳33326可由连续挤出工艺制得并且可包括沿其长度的连续横截面形状。现在参见图245-247，组织厚度补偿件33420可包括外壳33426、限定在外壳33426中的腔体33424、和定位在腔体33424内的芯33425。例如，外壳33426可包括由连续挤出形状形成的膜主体，并且芯33425可包括纤维药物芯，例如ORC。外壳33426可包括一个或多个柔性腿33423，所述一个或多个柔性腿33423能够延伸到限定于砧座22060中的刀狭槽22063内并且将组织厚度补偿件33420可释放地保持到砧座22060。现在参见图248-250，组织厚度补偿件33520可包括外壳33526、限定在外壳33526中的腔体33524、和定位在腔体33524内的芯33425。例如，外壳33526可包括由连续挤出形状形成的膜主体，并且芯33425可包括纤维药物芯，例如ORC。外壳33526可包括一个或多个保持构件33528，所述一个或多个保持构件33528能够围绕砧座22060的外表面延伸并且可将组织厚度补偿件33520可释放地保持到砧座22060。例如，主要参见图250，外壳33526可包括可移动部分33527和限定在可移动部分33527之间的间隙33523，其中在组织厚度补偿件33520已与砧座22060分离之后，可移动部分33527可弹开以暴露容纳于其中的芯33425。现在参见图251-252，组织厚度补偿件33620可包括外壳33626、限定在外壳33626中的腔体33424、和定位在腔体33424内的芯33425。例如，外壳33626可包括由连续挤出形状形成的膜主体，并且芯33425可包括纤维药物芯，例如ORC。外壳33626可包括薄部33623，所述薄部33623可与限定在砧座22060中的刀狭槽22063对齐，以使得穿过组织厚度补偿件33620的切割构件可穿过薄部33623并且减小横切组织厚度补偿件33620所需的力或能量。现在参见图253-254，组织厚度补偿件33720可包括外壳33726、限定在外壳33726中的腔体33424、和定位在腔体33424内的芯33425。例如，外壳33726可包括由连续挤出形状形成的膜主体，并且芯33425可包括纤维药物芯，例如ORC。外壳33726可包括一个或多个保持构件33723，所述保持构件33723能够包绕砧座22060的外表面并且可将组织厚度补偿件33720可释放地保持到砧座22060。现在参见图255-256，组织厚度补偿件33820可包括外壳33826、限定在外壳33826中的腔体33424、和定位在腔体33424内的芯33425。例如，外壳33826可包括由连续挤出形状形成的膜主体，并且芯33425可包括纤维药物芯，例如ORC。例如，外壳33826可包括基本上矩形的腔体33424和基本上平坦的组织接触表面33829，相比之下，图254中示出了弧形的腔体33424和组织接触表面。现在参见图257-258，组织厚度补偿件33920可包括外壳33926、限定在外壳33926中的多个腔体33924、和定位在每个腔体33924内的芯33925。例如，外壳33926可包括由连续挤出形状形成的膜主体，并且芯33925可各自包括纤维药物芯，例如ORC。芯33925可由不同的材料构成。外壳33926可包括一个或多个保持构件33923，所述保持构件33923能够延伸到砧座22060的刀狭槽22063中。
现在参见图153，可利用折叠工序来形成组织厚度补偿件。根据本发明，可将材料23525(例如，氧化再生纤维素)放置在覆盖片23526上，所述覆盖片23526可被折叠并且随后被密封以便包封材料23525。例如，覆盖片23526可由例如细胞骨架相关蛋白质甘氨酸构成。可利用连续工序，其中覆盖片23526可在料斗23592下穿过，所述料斗23592能够将材料23525分配到覆盖片23526上。例如，在将材料23525放置在覆盖片23526上之前，可在辊23591和砧座23590之间压平覆盖片23526。可将材料23525放置在覆盖片23526的一个侧面或半部上，其中可将覆盖片23526的另一侧面或半部折叠或翻转到材料23525上。在材料23525已放置在覆盖片23526上之前、期间和/或之后，可折叠或至少部分地折叠覆盖片23526。砧座23590可包括例如凸轮表面23594，所述凸轮表面23594能够例如提升纵向移动覆盖片23526的边缘或侧面并且随后对折覆盖片23526。凸轮表面23594可包括三维凸轮或圆筒凸轮，所述三维凸轮或圆筒凸轮在覆盖片23526经过凸轮表面23594时逐步提升并且翻转覆盖片23526的一部分。
在覆盖片23526已被折叠到材料23525上之后，折叠的覆盖片23526和定位在其中的材料23525可穿过模具23593，所述模具23593可压缩和/或压实折叠的覆盖片23526和材料23525以形成管23527。可利用诸如热焊接和/或激光焊接之类的任何合适工艺来密封折叠的覆盖片23526的边缘。管23527还可例如在管23527的侧壁已被密封之前通过一个或多个辊23595来压平。管23527还可在管23527的侧壁已被密封之后通过一个或多个辊来压平。在任何情况下，可将管23527分割成部分以产生单独的组织厚度补偿件。可利用诸如热焊接和/或激光焊接之类的任何合适工艺来密封组织厚度补偿件的末端，然而作为另外一种选择，组织厚度补偿件的一个或两个末端可保持在开口构型。
现在参见图154，补偿件可附接到砧座，例如，砧座22060，其中补偿件能够在其中储存至少一种药物。补偿件23620可包括中央主体部分23626以及能够附接到砧座22060的横向附接部分23628。补偿件23620还可包括限定在补偿件23620的组织接触表面23625中的毛细管通道23627的阵列，其中毛细管通道23627能够在其中储存一种或多种药物。例如，药物可包括流体，所述流体因流体张力而可被保持在毛细管通道23627的侧壁之间。在各种情况下，可在补偿件23620附接到砧座22060之前来将药物施用到补偿件23620，而在一些情况下，可例如在补偿件已附接到砧座22060之后来将药物施用到补偿件23620。在任何情况下，补偿件23620能够接触定位在砧座22060和背对砧座22060的钉仓之间的组织，其中储存于毛细管通道23627中的药物可流到组织上。在各种情况下，药物可流到毛细管通道23627内。
再次参见图154所示的补偿件23620，所述系列的毛细管通道23627可被构造和布置成交叉影线图案，其中第一数量的通道23627可沿着第一方向延伸并且第二数量的通道23627可沿着第二方向延伸。第一数量的通道23627可与第二数量的通道23627相交并且流体连通。现在参见图155，补偿件23920可包括主体23926，所述主体23926包括限定于组织接触表面23925中的毛细管通道23927的阵列。通道23927可沿着线性路径来限定，同时通道23927可沿着非线性路径来限定。例如，第一数量的通道23927可沿着轴线23923延伸，而第二数量的通道23927可沿着轴线23924延伸，其中轴线23923可沿着不同于轴线23924的方向延伸。轴线23923可垂直于或者至少基本上垂直于轴线23924，其中通道23627可在其间限定岛状物23922。例如，岛状物23922的顶部表面可限定补偿件23920的组织接触表面23925。补偿件23920可包括纵向轴线23921并且通道23627可沿着相对于纵向轴线23921横向或斜向的方向延伸。再次参见图154，补偿件23720可包括主体23726和限定于主体23726中的多个毛细管通道23727。补偿件23720还可包括可与毛细管通道23727流体连通的纵向通道23721。任选地，可将一种或多种药物储存在纵向通道23721中，其中药物可例如在通道23721和毛细管通道23727之间流动。通道23721可限定可向上延伸到限定于砧座22060中的纵向刀狭槽22061内的纵向突起。
如上所述，再次参见图154，限定于补偿件中的毛细管通道阵列可包括交叉影线图案。然而，作为另外一种选择，毛细管通道阵列可包括任何合适的形状或构型。例如，参见图154所示的补偿件23820，限定于补偿件23820的主体23826中的通道23827可包括例如平行、倾向通道，所述平行、倾向通道朝着中央通道23821会聚并且/或者远离中央通道23821而发散。现在参见图158，外科缝合器械的端部执行器可包括钉仓24000，所述钉仓24000包括组织厚度补偿件24010，其中组织厚度补偿件24010可在其中和/或在其上包括至少一种药物，例如，药物24001。现在参见图159，可将附接到砧座24060的补偿件24020例如移动到闭合位置，以便将补偿件24020放置成与组织厚度补偿件24010接触。在此类情况下，可将药物24001例如从组织厚度补偿件24010转移到补偿件24020。现在参见图160，补偿件24020可包括可与组织厚度补偿件24010接触的组织接触表面24025，其中药物24001可流到限定于组织接触表面24025中的毛细管通道24027内。现在参见图157，补偿件24020可在其上和/或在其中包括诸如药物24002之类的至少一种药物，所述至少一种药物可从补偿件24020转移到组织厚度补偿件24010。
现在参见图240和图241，组织厚度补偿件33020可包括限定于其表面中的多个通道和/或井凹。组织厚度补偿件33020可包括沿着穿过组织厚度补偿件33020限定的纵向轴线延伸的纵向通道33026。例如，纵向通道33026的末端可与组织厚度补偿件33020的周边流体连通。组织厚度补偿件33020还可包括多个井凹33022以及与井凹33022和纵向通道33026流体连通的多个斜向通道33024。组织厚度补偿件33020还可包括可与井凹33022和组织厚度补偿件33020的周边流体连通的多个入口-出口通道33027。任选地，由于上文所述，流体可在组织厚度补偿件已被植入到患者组织之前、期间、和/或之后流入和/或流出组织厚度补偿件33020。限定于组织厚度补偿件33020的组织接触表面33025中的通道33024、33026和33027以及井凹33022的图案可限定抓持边缘，所述抓持边缘能够接触组织并且限制组织厚度补偿件33020和组织之间的滑动。现在参见图240A和图241A，组织厚度补偿件33120可包括限定于其表面中的多个圆形通道。组织厚度补偿件33120可包括同心圆形通道33127，所述同心圆形通道33127包括限定于组织厚度补偿件33120的周边中的开口。与上文相似，流体可通过通道33127流入和/或流出组织厚度补偿件33120。组织厚度补偿件33120可包括同心圆形通道33122，所述同心圆形通道33122可不包括限定于组织厚度补偿件33120的周边中的开口。现在参见图242和图243，组织厚度补偿件33220可包括从其延伸的多个脊33227，所述脊33227能够抓持紧靠组织厚度补偿件33220定位的组织。例如，脊33227可为直的或者脊33227可包括弯曲轮廓。尽管上述的脊和通道可用于组织厚度补偿件，但此类脊和通道可与任何合适的可生物吸收的和/或生物相容性的层一起使用。
根据本发明，补偿件可由多个层构成。例如，补偿件可包括第一层和附接到第一层的第二层。第一层可包括组织接触表面和限定于组织接触表面中的多个毛细管通道。第一层还可包括限定于面向第二层并且背向组织接触表面的侧面中的毛细管通道。第二层可包括限定于其中的毛细管通道。井凹可限定在补偿件的第一层和第二层之间。可例如在形成层的模塑工艺期间和/或在热铆焊工艺期间利用任何合适的方法来将毛细管通道形成于补偿件的层中。例如，可利用热铆焊工艺来将补偿件的层彼此附接在一起。例如，层可由下述材料构成，所述材料在被施加热时可变成可变形的，例如，CAP/GLY(36/64)。在任何情况下，限定于补偿件的组织接触表面中的毛细管通道可在其间限定抓持表面，所述抓持表面可改善可施加到定位在外科缝合器械的砧座和钉仓之间的组织的抓持和控制。换句话讲，限定于补偿件的组织接触表面的毛细管通道可减小补偿件可接触组织的面积。在此类情况下，对于给定的力而言，补偿件和组织之间的较小接触面积可导致较高的接触压力。在各种情况下，较高的接触压力可降低补偿件和组织之间的滑动。
任选地，可将一种或多种药物定位在限定于第一层和第二层内和/或之间的毛细管通道和/或空隙内。构成补偿件的多个层可包括一组治疗剂层或治疗剂。例如，第一层可由第一药物构成并且第二层可由第二药物构成，其中第一药物可不同于第二药物。例如，限定于第一层中的毛细管通道可储存第三药物，并且限定于第二层中的毛细管通道可储存第四药物，其中第一药物、第二药物、第三药物和/或第四药物可例如为不同的。第一药物、第二药物、第三药物和/或第四药物可例如为不同的。现在参见图161，补偿件24120可包括多个层，例如，层24121-24125。第一层24121和/或第五层24125可包括可夹置第二层24122、第三层24123和/或第四层24124的平材料片。任选地，层24121-24125中的一个或多个可包括限定于其中的一个或多个通道24127。通道24127可从补偿件24120的一端延伸到另一端，并且通道24127可从补偿件24120的一侧延伸到另一侧。通道24127可在补偿件24120的任何合适的侧面和/或末端之间沿着任何合适的方向延伸。现在参见图164和图165，补偿件24820可包括例如可限定横向通道24822的两个或更多个内层24827，所述横向通道24822从补偿件24820的一侧延伸到另一侧。再次参见图161，限定于层24121-24125中的一个内的通道24127可与限定于与其相邻定位的层中的通道对齐。限定于层24121-24125中的一个内的通道24127可面向或开口朝向与其相邻定位的层上的平坦表面。再次参见图161，层24121-24125中的一个或多个可包括限定于其中的至少一个井凹24129。井凹24129可与限定于层中的一个或多个通道24127流体连通。与上文相似，井凹24129可包括开口朝向或面向相邻层的开口，其中相邻层可覆盖开口。
对上文进行进一步描述，通道24127和/或井凹24129能够在其中包含一种或多种药物。通道24127可包括可允许药物流出通道24127的一个或多个开口端。相似地，通道24127可包括能够允许流体(例如，血液)流到通道24127内的一个或多个开口。在此类情况下，流体可流到补偿件24120内、吸收药物和/或层24121-24125的至少一部分、并且随后流出补偿件24120。再次参见图164和图165，补偿件24820可包括例如限定于外层24826中的孔24828。再次参见图161，层24121-24125可由任何合适的材料构成，例如，可生物吸收的聚合物、PLA、和/或PGA。层24121-24125中的全部可由相同的材料构成。作为另外一种选择，层24121-24125中的一个或多个可由不同的材料构成。任选地，层24121-24125的一个或多个可包括贯穿延伸的通孔24128，所述通孔24128例如能够允许诸如血液之类的流体流到通道24127内、井凹24126内、和/或层24121-21135中的两个或更多个之间。可利用例如热焊接和/或激光焊接工艺来将层24121-24125中的一个或多个彼此连接在一起。在此类情况下，流到补偿件24120内的流体可溶解层24121-24125的焊接部分，并且允许层24121-24125分离和/或剥离。层24121-24125中的一个或多个可由以下材料构成，所述材料以快于和/或慢于构成其他层24121-24125的材料的速率溶解。例如，补偿件24120的内层24122-24124可由例如以快于构成外层24121和24125的材料的速率溶解的材料构成。在此类情况下，当补偿件24120的内部被溶解掉时，补偿件24120可保持一致的或者至少基本上一致的整体形状。补偿件的最外层可由例如以快于构成补偿件的最内层的材料的速率溶解的材料构成。例如，层可包括具有介于大约1密耳和大约4密耳之间的厚度的材料片。
现在参见图162和图163，诸如补偿件24220之类的补偿件可包括能够附接到砧座(例如，砧座22060)和/或钉仓的支撑层24226。补偿件24220还可包括附接到支撑层24226的支架24222，其中支架24222可包括多个支架层24227。支架可包括例如三维结构化基质。任选地，支架层24227中的每一个可由多个纤维构成。现在参见图166，每个支架层24227可由纤维编织物构成，所述纤维编织物包括沿第一方向延伸的第一多个纤维24228和沿第二或不同方向延伸的第二多个纤维24229。每个纤维编织物可包括多个凹坑或腔体24223，其中层24227、纤维24228、24229、以及腔体24223可限定有助于组织和细胞向内生长的基质。纤维24228、24229和/或任何其他合适的纤维可由可生物吸收材料构成。纤维可由例如止血剂、结合活性剂(例如，具有生物活性和/或药理学活性的那些)、和/或支撑构件(其可彼此交织在一起)构成。在任何情况下，可选择纤维的材料以导致所需的生物反应，例如，细胞迁移到支架24222内、ECM分泌、和/或结构化支撑细胞的增殖。
对上文进行进一步描述，支撑层24226能够在结构上支撑支架24222。可例如利用一种或多种可生物吸收粘合剂来将支架24222附接到支撑层24226。相似地，可利用例如一种或多种生物相容性粘合剂来将支撑层24226附接到砧座或钉仓。可以任何合适的方式来布置或堆叠支架24222的层24227。每个层24227可包括纤维的图案，其中层24227可被布置在支架24222中以使得层24227的图案为彼此对齐的。参见图167，可将层24227堆叠在彼此之上，使得第一层24227中的纤维24228与第二层24227中的纤维24228对齐。同样，可将层24227堆叠在彼此之上，使得第一层24227中的纤维24229与第二层24227中的纤维24229对齐。现在参见图168，支架24422可包括多个支架层24427，其中每个支架层24427中的纤维24429沿着相同方向进行取向，例如，纵向方向。现在参见图170，每个支架层24227可包括纤维的图案，其中层24227可被布置在支架24322中以使得层24227的图案彼此不对齐。可将层24227堆叠在彼此之上，使得第一层24227中的纤维24228沿着横向于或者斜向于第二层24227中的纤维24228的方向延伸。同样，可将层24227堆叠在彼此之上，使得第一层24227中的纤维24229沿着横向于或者斜向于第二层24227中的纤维24229的方向延伸。现在参见图171，支架24522可包括例如多个支架层24427，所述多个支架层24427被取向成使得每个支架层24427中的纤维24229沿着不同方向进行取向。
对上文进行进一步描述，支架24222的第一支架层24227例如可由第一材料构成，而支架24222的第二支架层24227可由第二或不同材料构成。例如，第一材料可包括第一药物，而第二材料可包括第二或不同药物。对上文进行进一步描述，例如，支架24222的第一支架层24227例如可包括被吸收到其纤维内的第一药物，而支架24222的第二支架层24227可包括被吸收到其纤维内的第二或不同药物。例如，第一材料可包括第一药物，而第二材料可包括第二或不同药物。支架可包括具有任何合适纤维密度的任何合适数目的层，所述纤维由任何合适数目的材料构成。
可利用保持器来将组织厚度补偿件安装在外科装置(例如，外科切割和缝合装置)中。保持器可包括抓持表面并且允许外科医生、护士、技术人员或其他人员将组织厚度补偿件中的一个或多个与外科器械的特征(例如，砧座和/或钉仓)对齐。保持器可包括通过接合外科器械的钉仓来对齐一个或多个组织厚度补偿件的特征。保持器可包括通过接合外科器械的砧座来对齐一个或多个组织厚度补偿件的特征。用于外科器械的钉仓可与保持器包括在一起，并且使保持器与外科器械接合可将钉仓安装在外科器械中并可对齐组织厚度补偿件中的一个或多个。在组织厚度补偿件已对齐并且附接到外科器械之后，可使保持器与组织厚度补偿件分离，并且随后从外科器械移除。
图61-67示出了例如可用于将第一组织厚度补偿件19002附接到砧座19040并且将第二组织厚度补偿件19004附接到外科缝合器的钉仓19050的保持器19000的实施例。可提供包括保持器19000、第一组织厚度补偿件19002和第二组织厚度补偿件19004的保持器组件19060。一般来讲，在使用期间，可将保持器组件19060插入到砧座19040和能够支撑钉仓19050的通道之间。然后，可闭合砧座19040。通过闭合砧座19040，可将砧座19040向下推压到第一组织厚度补偿件19002上，以使得第一组织厚度补偿件19002可附接到砧座19040。闭合砧座19040向下推压保持器19000并且将钉仓19050设置在外科器械的通道内。当重新打开砧座19040时，第一组织厚度补偿件19002可与保持器19000分离，并且当随后从外科装置移除保持器19000时，保持器19000可与第二组织厚度补偿件19004分离。外科装置随后准备就绪，以与附接到砧座19040的第一组织厚度补偿件19002和附接到钉仓19050的第二组织厚度补偿件19004一起使用。
参见图61，保持器19000可包括抓持件19014，所述抓持件19014可供准备外科器械的人员(例如，外科医生、护士或技术人员)抓持保持器19000。保持器19000可包括其上可定位第一组织厚度补偿件19002的第一表面19001和其上可定位第二组织厚度补偿件19004的相对的第二表面19003。任选地，可将一种或多种粘合剂施用到第一表面19001和/或第二表面19003，以用于向其附接第一组织厚度补偿件19002和第二组织厚度补偿件19004。保持器19000还可包括例如可接合外科装置的钉仓19050的夹具。参见图64，保持器19000可包括能够接合钉仓19050的远侧末端处的凹槽19056的远侧夹具19108、和/或能够接合钉仓19050上的脊或边缘19054的近侧夹具19106。
参见图61，第一组织厚度补偿件19002可包括面向保持器表面19006和面向砧座表面19010。可通过例如粘合剂和/或接合特征来将面向保持器表面19006附接到保持器19000的第一表面19001。面向砧座表面19010可在其上包括至少一种粘合剂，所述粘合剂可将第一组织厚度补偿件19002附接到外科装置的砧座19040。例如，粘合剂可包括可附着到砧座19040的钉成形表面19044(图63)的可活化粘合剂。
参见图61和图63-66，第一组织厚度补偿件的面向砧座表面19010可包括接合砧座19040上的相似接合特征19042的接合特征19020。因此，第一保持力可将第一组织厚度补偿件19002保持到保持器19000，并且第二保持力可将第一组织厚度补偿件19002保持到砧座19040。第二保持力可大于第一保持力，以使得当从端部执行器移除保持器19000时，第一组织厚度补偿件19002可保持附接到砧座19040并且可与保持器19000分离。
再次参见图61，第二组织厚度补偿件19004可包括面向保持器表面19008和面向钉仓表面19012。可通过一种或多种粘合剂和/或接合特征来将面向保持器表面19006附接到保持器19000的第一表面19001。面向钉仓表面19012可在其上包括粘合剂，所述粘合剂可将第二组织厚度补偿件19004附接到外科装置的钉仓19050。例如，参见图64，粘合剂可将第二组织厚度补偿件19004附着到钉仓19050的钉平台19052。面向钉仓表面19012还可包括接合钉仓19050上的协作接合特征的接合特征。因此，第一保持力可将第二组织厚度补偿件19004保持到保持器19000，并且第二保持力可将第二组织厚度补偿件19004保持到钉仓19050。第二保持力可大于第一保持力，以使得当从端部执行器移除保持器19000时，第二组织厚度补偿件19004可保持附接到钉仓19050并且可与保持器19000分离。
如图64所示，可将保持器组件19060按照箭头A所示的方式附接到钉仓19050。如上所述，保持器19000上的远侧夹具19018可接合钉仓中的凹槽19056，并且保持器上的近侧夹具19016可接合钉仓19050上的边缘或脊19054。此时，保持器19000附接到钉仓19050，如图65所示，并且第二组织厚度补偿件19004可附接到钉仓19050。如图66所示，外科装置的砧座19040沿箭头B方向的闭合可使得砧座的表面19044(例如，钉成形表面和/或组织接触表面)与第一组织厚度补偿件19002接触。如上所述，接触第一组织厚度补偿件19002的砧座19040可使得第一组织厚度补偿件19002附接到砧座19040。
在保持器组件19060已附接到钉仓19050并且砧座19040已闭合之后，可将第一组织厚度补偿件19002附接到砧座19040，并且可将第二组织厚度补偿件19004附接到钉仓19050。如上所述，将第一组织厚度补偿件19002保持到保持器19000的保持力可小于将第一组织厚度补偿件19002保持到砧座19040的保持力。因此，当重新打开砧座19040时，第一组织厚度补偿件19002可与保持器19000分离并且可与砧座19040保持在一起，如图67所示。另外如上所述，将第二组织厚度补偿件19004保持到保持器19000的保持力可小于将第一组织厚度补偿件19004保持到钉仓19050的保持力。因此，当沿着图67所示的箭头C和箭头D的方向移除保持器19000时，保持器19000可与第二组织厚度补偿件19004分离。图67所示的外科缝合器包括附接到砧座19040的第一组织厚度补偿件19002和附接到钉仓19050的第二组织厚度补偿件19004，并且已准备就绪可供使用。
图390-396示出了正与第一组织厚度补偿件19002和第二组织厚度补偿件19004一起使用的保持器19000。保持器19000还可与第一组织厚度补偿件19002和第二组织厚度补偿件19004中的仅一者一起使用。例如，可省去第一组织厚度补偿件19002。
图68-70示出了可包括表面19101上的接合特征19108的保持器19100的实施例。如图69和图70所示，保持器19100上的接合特征19108接合第一组织厚度补偿件19102上的协作接合特征19109。
图71和图72示出了可包括能够将组织厚度补偿件19210对齐和附接到砧座19230的表面19202的保持器19200的实施例。保持器19200可包括从表面19202延伸的对齐栓19204。图71和图72所示的保持器19200包括四个对齐栓19204，但可提供更多或更少的对齐栓19204。参见图72，组织厚度补偿件19210可包括主体19212，所述主体19212包括孔19216，所述孔19216可被定位成使其对应于从保持器19200延伸的对齐栓19204的位置。组织厚度补偿件19210中的每个孔19216配合在对齐栓19204上，并且由于孔19216和栓19204之间的紧密配合，可将组织厚度补偿件19210与保持器19200对齐。任选地，每个孔19216可略小于其对应的栓19204，使得每个孔19216在置于其栓19204上时扩展。这种扩展可将孔19216保持在栓19204上。每个孔19216可在其中包括粘合剂，以在栓19204和组织厚度补偿件19210之间产生可释放的粘结。
组织厚度补偿件19220可包括从组织厚度补偿件19220的主体19212延伸的能够被砧座19230中的狭槽19234接收的插片19220。砧座19230中的狭槽19234可例如定位在钉成形表面19232中。在保持器19200已附接到钉仓之后，与上文相似，砧座19230可紧靠保持器19200上的组织厚度补偿件19210进行闭合。当砧座19230闭合时，参见图72，组织厚度补偿件19210上的插片19220可接合狭槽19234，从而将组织厚度补偿件19210附接到砧座19230。主要参见图71，每个插片19220可包括将插片19220引导到砧座19230的狭槽19234内的渐缩部分19222。渐缩部分19222可包括倾斜壁并且可具有沿其长度递增的横截面积。每个插片19220的基体部分19226可具有小于渐缩部分19222的最大横截面积的横截面积。渐缩部分19222可包括锁定表面19224，其中当插片19220进入狭槽19234时，锁定表面19224可卡扣到狭槽19234的唇缘19235上。因此，锁定表面19224可将插片19220保持在狭槽19234内，从而将组织厚度补偿件19210保持到砧座19230。限定于组织厚度补偿件19210中并且延伸在插片19220之间的狭槽19228可允许插片19220向内挠曲并且配合在狭槽19234内。正利用狭槽19234保持的插片19220可限定将组织厚度补偿件19210保持到砧座19230的第一保持力，并且正保持在栓19204上的组织厚度补偿件19210中的孔19216可限定第二保持力。第一保持力可大于第二保持力，使得当从端部执行器移除保持器19200时，第一组织厚度补偿件19210可保持附接到砧座19230并且可与保持器19200分离。
图71和图72中的组织厚度补偿件19210的主体19212还可在其内限定狭槽19214。狭槽19214可沿着组织厚度补偿件19210的纵向轴线对齐。例如，可将狭槽19214布置在纵向轴线上，使得当将组织厚度补偿件19210附接到砧座19230时，狭槽19214与外科装置的切割刀的纵向路径对齐。狭槽19214可降低切割刀切穿组织厚度补偿件19210所需的能量值。
图73-83示出了包括夹具19310的保持器19300的实施例，所述夹具19310能够将组织厚度补偿件19340保持在保持器19300的第一表面19302上。当砧座19360闭合在保持器19300上时，与上文相似，砧座19360可向外推压和移动夹具19310，并且由此使保持器19300从组织厚度补偿件19340脱离。当重新打开砧座19360时，砧座19360紧靠组织厚度补偿件19340进行挤压并且移动远离保持器19300，由此使得组织厚度补偿件19340可附接到砧座19360。
保持器19300可包括钉仓安装夹具19312和19314，所述钉仓安装夹具19312和19314可与上文相对于图61-70所述的那些相似。除了上文所述的第一表面19302之外，保持器19300还可包括能够承载第二组织厚度补偿件的第二表面19304。第二表面19304可包括对齐结构，例如，凸起脊19308。凸起脊19308可接合例如第二组织厚度补偿件中的狭槽和/或钉仓19370中的狭槽。
参见图75-77，在使用期间，可通过夹具19314和19312来将保持器19300附接到钉仓19370。第一组织厚度补偿件19340可定位在保持器19300处的第一表面19302上，并且可通过夹具19310保持固定。主要参见图81-83，每个夹具包括可紧靠保持器19300的第一表面19302夹持第一组织厚度补偿件19340的扁平件19313。每个夹具19310可包括面向内的锥形或弯曲表面19311。当砧座19360沿着箭头E的方向移动时，参见图82，砧座19360的边缘19366可接触夹具19310的面向内的弯曲表面19311。当砧座19360继续沿着箭头E的方向移动时，砧座19360的边缘19366和夹具19310的弯曲表面19311之间的干扰可沿着箭头F的方向向外推压夹具19310，如图82所示。当夹具19310沿着箭头F的方向移动时，第一组织厚度补偿件19340从夹具19310的扁平件19313释放。
当砧座19360继续沿着箭头E的方向移动时，其还接触并且附接到组织厚度补偿件19340。例如，当砧座19360沿着箭头E的方向移动时，组织厚度补偿件19340上的接合特征(例如，凸起脊19344)接合砧座19360中的通道19364。凸起脊19344能够与通道19364具有过盈配合，以使得组织厚度补偿件19340附接到砧座19360。组织厚度补偿件19340可包括附着到砧座19360的表面的粘合剂。凸起脊19344可包括附着到通道19364的表面的粘合剂。同样，组织厚度补偿件19340的主体19342的表面可包括附着到砧座19360的表面19362的粘合剂。在组织厚度补偿件19340附接到砧座19360之后，当砧座19360通过沿着箭头G的方向移动而返回到其打开位置时，如图83所示，组织厚度补偿件19340可从保持器19300提升并且可与砧座19360保持在一起。
图84示出了保持器19400的实施例的剖视侧视图。第一组织厚度补偿件19410定位在保持器19400的第一侧面19402上，并且第二组织厚度补偿件19420定位在保持器19400的第二侧面19404上。保持器19400限定贯穿延伸的一个或多个孔19406。通过延伸穿过孔19406的连接件19430并穿过孔来连接第一组织厚度补偿件19410和第二组织厚度补偿件19420。第一组织厚度补偿件19410、第二组织厚度补偿件19420、以及连接件19430全部可由单一材料形成。例如，可将第一组织厚度补偿件19410、第二组织厚度补偿件19420、以及连接件19430重叠注塑到保持器19400上。作为另外一种选择，连接件19430可形成为组织厚度补偿件中的一者(例如，第一组织厚度补偿件19410)的部分。连接件19430可穿过孔19406，并且随后附接到剩余的组织厚度补偿件，例如，第二组织厚度补偿件19420。可例如通过利用粘合剂或通过连接件的末端与第二组织厚度补偿件19420中的接纳端口(未示出)之间的过盈配合来将连接件19430附接到第二组织厚度补偿件19420。连接件19430可为单独部件，所述单独部件放置在孔19406内并且可通过例如利用粘合剂或者连接件19430的末端与第一组织厚度补偿件19410和第二组织厚度补偿件19420中的接纳端口之间的过盈配合来附接到第一组织厚度补偿件19410和第二组织厚度补偿件19410。
在保持器19400已放置在钉仓19450上之后，例如，可将外科装置的砧座19440沿着箭头H的方向移动到闭合位置。当砧座19440闭合时，第一组织厚度补偿件19410的表面19414上的粘合剂和/或接合特征可将第一组织厚度补偿件19410附接到砧座19440。同样，第二组织厚度补偿件19420的表面19424上的粘合剂和/或接合特征可将第二组织厚度补偿件19420附接到钉仓19450。在砧座19440闭合并且第一组织厚度补偿件19410和第二组织厚度补偿件19420分别附接到砧座19440和钉仓19450之后，可沿着箭头I的方向(图88)牵拉保持器19400以从第一组织厚度补偿件19410和第二组织厚度补偿件19420之间移除保持器19400并且使连接件19430断裂。如图89所示，在连接件19430断裂和保持器19400已被移除之后，可重新打开砧座19440，第一组织厚度补偿件19410将附接到砧座19440并且第二组织厚度补偿件19420将附接到钉仓19450。
根据本发明，保持器19400中的每个孔19406的近侧部分19407可包括切割刃。当沿着箭头I(图88)的方向牵拉保持器时，通过孔19406的近侧部分19407传送牵拉力以使连接件断裂。每个孔19406的近侧部分19407处的切割刃将传送的力集中在每个连接件的相对较小的区域上。因此，连接件将较容易地断裂并且可需要较小的牵拉力来从第一组织厚度补偿件19410和第二组织厚度补偿件19420之间移除保持器19400。
如上所述，保持器组件可包括定位在第一组织厚度补偿件和第二组织厚度补偿件之间的保持器，其中在两个组织厚度补偿件已插入并且附接到外科器械的端部执行器时，保持器可从组织厚度补偿件之间进行牵拉并且可从端部执行器移除。保持器可提供第一组织厚度补偿件和第二组织厚度补偿件之间的屏障。一旦从第一组织厚度补偿件和第二组织厚度补偿件之间移除保持器，第一组织厚度补偿件之中和/或之上的物质就例如可与第二组织厚度补偿件之中和/或之上的物质发生反应。组织厚度补偿件中的一个或两个可包括可将物质包封在组织厚度补偿件的膜。可将膜附接到保持器，其中当从组织厚度补偿件之间牵拉保持器时，如上所述，保持器可牵拉膜远离组织厚度补偿件以暴露容纳于其中的物质。此时，每个组织厚度补偿件内的物质均可彼此相互作用。
图90-100示出了接合外科装置(例如，外科缝合器)的砧座的保持器的实施例。保持器可将第一组织厚度补偿件与砧座对齐并且将第二组织厚度补偿件与钉仓对齐。闭合砧座导致第一组织厚度补偿件附接到砧座，并且导致第二组织厚度补偿件附接到钉仓。保持器还可承载钉仓，其中组织厚度补偿件任选地设置在保持器和钉仓之间。闭合砧座导致钉仓附接到外科缝合器的通道并且导致第一组织厚度补偿件附接到砧座。
图90-93示出了保持器19500的实施例。保持器19500包括可供外科医生、护士、技术人员或其他人员操纵保持器19500的抓持件19502。抓持件19502可包括可提供较好的抓持表面的纹理化表面，例如凸起部分19503。保持器19500可包括其上可安装组织厚度补偿件的表面19504。表面19504可包括一个或多个突出部19506，其中突出部19506可接合组织厚度补偿件中的凹槽并且相对于保持器19500的表面19504来对齐组织厚度补偿件。组织厚度补偿件中的凹槽可略小于突出部19506，使得当与凹槽接合时，突出部19506可将组织厚度补偿件保持到表面19504。突出部19506可穿过组织厚度补偿件中的孔并且接合狭槽(例如，图95所示的砧座19550中的切割刀狭槽19558)，从而使组织厚度补偿件与保持器19500对齐并且提供保持器19500与砧座19550的附加对齐。组织厚度补偿件19540可包括如上所述的表面19542上的粘合剂和/或接合特征以用于将组织厚度补偿件附接到砧座19550。
如图94a所示，可将钉仓19530附接到保持器19500。可通过从保持器19500延伸的夹具19510和19512来将钉仓19530附接到保持器19500。保持器19500上的夹具19512可接合钉仓19530中的狭槽19534。保持器19500的夹具19510可围绕钉仓19532的底部19532。根据本发明，可将第二组织厚度补偿件附接到钉仓19530。可将第二组织厚度补偿件附接到钉仓19530的钉平台19536。
如图95和图96所示，可将包括保持器19500、组织厚度补偿件19540和钉仓19530的保持器组件19590沿着箭头L的方向滑动到外科装置(例如，外科缝合器)的砧座19550上。保持器19500上的引导插片19508可围绕砧座19550的边缘19552，并且相对于砧座19550来定位保持器组件19590。在保持器组件19590接合到砧座19550上之后，如图97和图98所示，可沿着箭头M的方向来闭合砧座。砧座19550的闭合可将钉仓19530定位在外科装置的通道19560中。砧座19550的闭合可导致从保持器19500延伸的夹具19510接合通道19560的脊19562，以便将钉仓19530牢固地定位在通道19560中。当沿着箭头N的方向重新打开砧座19550时，现在参见图99和图100，组织厚度补偿件19540可保持附接到砧座19550并且与保持器19500分离。然后可沿着箭头O(图99和图100)的方向来从外科器械移除保持器19500，从而留下位于外科装置的通道19560中的钉仓19530和附接到砧座19550的组织厚度补偿件19540。
图101和图102分别示出了组织厚度补偿件19570和19580的两个可供选择的实施例的例子。图101是附接到保持器19501的组织厚度补偿件19570的剖视图，其中组织厚度补偿件19570可包括突起19574，所述突起19574可接触砧座19550的边缘19552并且部分地围绕砧座19550的外表面19556。突起可抓持砧座19550和/或可利用一种或多种粘合剂附接到砧座19550。为了在已相对患者组织植入补偿件19570之后从砧座19550释放组织厚度补偿件19570，突起19574可从砧座19550向外挠曲，从而允许组织厚度补偿件19570被牵拉远离砧座19550。图102是附接到图101所示的保持器19501的组织厚度补偿件19580的剖视图。组织厚度补偿件19580包括承套19584，所述承套19584可包围砧座19550以使组织厚度补偿件19580与砧座19550对齐并且/或者将组织厚度补偿件19580保持在砧座19550上。承套19584可将组织厚度补偿件19580保持在砧座19550上。为了使承套19584与砧座19550分离，组织厚度补偿件19580例如可在穿孔19586处撕裂以离开承套19584。因此，承套19584可保持在砧座19550上，而组织厚度补偿件19580的其余部分可保持缝合到患者组织。
组织厚度补偿件(例如，组织厚度补偿件19570)可包括内部部分，所述内部部分包括定位在其中的生物相容性物质。生物相容性物质可包括例如抗炎剂、凝结剂、和/或抗生素。根据本发明，可将诸如晶片之类的主体插入到组织厚度补偿件内的内部部分中。例如，可将晶片通过组织厚度补偿件的开口端插入到限定于其中的腔体内。晶片可通过过盈配合保持在组织厚度补偿件的腔体内。用于将晶片组装到组织厚度补偿件内的步骤可包括加热组织厚度补偿件以使组织厚度补偿件扩张的第一步骤。当组织厚度补偿件扩张时，限定于其中的腔体也可扩张。当组织厚度补偿件处于扩张状态时，根据第二步骤，可将晶片插入到腔体内。然后，当组织厚度补偿件冷却时，根据第三步骤，腔体可收缩到晶片上并且将晶片保持在腔体内的适当位置。
图103-115示出了包括独立插入工具的保持器的实施例。插入工具可用于将组件插入到诸如外科缝合器之类的外科器械内。插入工具还可将保持器组件的钉仓和一个或多个组织厚度补偿件挤压到外科器械内的适当位置。参见图103和图104，保持器19600可包括第一板19620和第二板19622。第一板19620和第二板19622可通过铰链19612进行连接。铰链19612可将第一板19620定位成相对于第二板19622成一角度，并且还可允许第一板19620相对于第二板19622围绕铰链19612旋转。
第一板19620可包括向外表面19604和向内表面19606。同样，第二板19622可包括向外表面19610和向内表面19608。第一板19620的向内表面19606可包括凸轮突起19614。相似地，第二板19622的向内表面19608可包括凸轮突起19616。参见图110-115，第一板的向外表面19604可包括定位在其上的组织厚度补偿件。第二板19622的向外表面19601也可包括定位在其上的组织厚度补偿件。可例如利用粘合剂、接合特征、和/或其他合适的附接部件来将组织厚度补偿件附接到外表面19604和19610。保持器19600可包括从第二板19622延伸的能够接合钉仓19690的夹具19618，如图110和图112-115所示。
现在参见图105-109，插入工具19630可包括第一末端19632和第二末端19634。第一末端19632可为足够大的，以供例如外科医生、护士和/或技术人员抓紧。第二末端19634限定腔体19640，其中腔体可包括定位在其中的凸轮19648。凸轮19648的第一侧面可包括第一突出部19642、第二突出部19644、和定位在两者间的第一下凹部19646。凸轮19648的第二侧面可包括第三突出部19643、第四突出部19645、和定位在两者间的第二下凹部19647。例如，突出部和下凹部可以镜像方式进行布置。换句话讲，可将第一突出部19642以正对凸轮19648的第二侧面上的第三突出部19643的方式布置在凸轮19648的第一侧面上。同样，可将第二突出部19644以正对凸轮19648的第二侧面上的第四突出部19645的方式布置在凸轮19648的第一侧面上。另外，可将第一下凹部19464以正对凸轮19648的第二侧面上的第二下凹部19647的方式布置在凸轮19648的第一侧面上。
在使用期间，可将插入工具19630的第二末端19634放置在保持器19600的第一板19620和第二板19622之间，使得例如第一板19620上的凸轮突起19614与下凹部19646接合并且使得第二板19622上的凸轮突起19616与下凹部19647接合。如图112和图113所示，可将包括保持器19600、插入工具19630、一个或多个组织厚度补偿件、和钉仓19690的插入组件19700插入到外科器械内。外科器械(例如，外科缝合器)可包括砧座19720和能够接收钉仓19690的通道19740。可将插入组件19700沿着箭头P的方向(图113)插入到外科器械内以将钉仓19690锁定在通道19740内。在此位置中，凸轮19614和19616可分别与下凹部19646和19647对齐。
在钉仓19690锁定在通道19740内之后，如图114所示，插入工具19600可相对于外科器械继续沿着箭头Q的方向进行移动。插入工具19600沿箭头Q的方向的进一步移动可使第一突出部19642与第一凸轮突起19614对齐，并且使第三突出部19634与第二凸轮突起19616对齐。这种对齐可导致保持器板19620和19622围绕铰链19612沿着箭头R的方向(图114)以彼此远离的方式旋转。在此类情况下，保持器板19620和组织厚度补偿件19670可移向砧座19720，并且保持器板19622可移向且接触砧座19720。任选地，由于上文所述，可将组织厚度补偿件19670置于砧座19720上。在组织厚度补偿件19670附接到砧座19720之后，可沿着箭头S的方向(图115所示)回缩或移动插入工具19630。插入工具19630沿箭头S的方向的移动可导致凸轮突起19614和19616分别与第一突出部19642和第三突出部19643分离，并且变为分别与第一下凹部19646和第二下凹部19647再次对齐。第二突出部19642和第四突出部19645可分别邻接凸轮突起19614和19616，并且可阻止插入工具19630与保持器19600完全分离。在凸轮突起19614和19616与下凹部19646和19647再次对齐的情况下，第一板19620可围绕铰链19612至少部分地朝着第二板19622并且远离砧座19720而旋转。还可使保持器19600与通道19740分离，并且随后沿着箭头S的方向移出，从而留下例如附接到砧座19720的组织厚度补偿件19670。
如本文所述，保持器组件可用于将一个或多个组织厚度补偿件安装到外科缝合器械的端部执行器内。保持器组件可将除组织厚度补偿件之外的层安装到外科器械内。层可包括例如可吸收材料和/或生物相容性材料。
参见图172，端部执行器12能够接收端部执行器插入件25002。端部执行器12可包括下钳口25070以及能够相对于下钳口25070枢转的砧座25060。端部执行器插入件25002可包括能够枢转地连接到砧座插入件25004的钉仓25000。端部执行器12能够接收端部执行器插入件25002，使得钉仓25000配合在例如下钳口25070的钉仓通道25072内并且使得砧座插入件25004接触例如砧座25060。下钳口25070可包括能够将钉仓25000固定到钉仓通道25072的多个固定构件25074。砧座插入件25004可包括能够接合砧座25060中的至少一个保持沟槽的至少一个保持突起。砧座插入件25004能够在砧座25060朝下钳口25070枢转时相应地朝钉仓25000枢转，如本文更详细地描述。
仍参见图172，端部执行器插入件25002还可包括保持器25010。保持器25010可牢固地接合钉仓25000和砧座插入件25004中的至少一者。保持器25010可包括可夹住、接合、卡扣、夹紧、和/或勾住钉仓25000的至少一个固定夹具25012。如图172所示，保持器25010可包括例如位于其每一纵向侧的两个固定夹具25012。例如，固定夹具25012能够夹在例如钉仓25000的一部分上。根据本发明，组织厚度补偿件可通过保持器25010来相对于端部执行器插入件25002保持固定。例如，可将组织厚度补偿件定位在保持器25010和钉仓25000之间。
任选地，当操作者正将端部执行器插入件25002插入到端部执行器12内时，保持器25010可提供固体的或基本上固体的元件以供操作者抓紧。此外，保持器25010可阻止由例如保持器25010限定的组织厚度补偿件的过早变形。可在利用端部执行器12切割和/或紧固组织之前将保持器25010从端部执行器12移除。作为另外一种选择，保持器25010可保持定位在端部执行器12中。例如，当钉从钉仓25000的腔体25002(图207)击发时，可通过切割元件25052(图)击发时，可通过切割元件25052横切端部执行器插入件28010。保持器25010可包括聚合物组合物，例如，可生物吸收的生物相容性弹性体聚合物。保持器25010还可包括可生物吸收的聚合物，例如，冻干多糖、糖蛋白类、弹性蛋白、蛋白聚糖、明胶、胶原和/或氧化再生纤维素(ORC)。保持器25010可包括至少一种治疗剂，例如药物活性剂或药物。
参见图173，端部执行器26012可包括砧座26060和下钳口26070。根据本发明，可将组织补偿件26020可释放地固定到砧座26060、下钳口26070、和/或砧座26060和下钳口26070两者。例如，可将第一组织补偿件26020可释放地固定到下钳口26070中的钉仓26000，并且可将第二组织补偿件26022可释放地固定到砧座26060。第一组织补偿件26020和第二组织补偿件26022可为可变形的和/或弹性的，这类似于本文所述的至少一个组织厚度补偿件。例如，第一组织补偿件26020和第二组织补偿件26022可包括聚合物组合物，例如可生物吸收的生物相容性弹性体聚合物。第一组织补偿件26020和第二组织补偿件26022还可包括可生物吸收的聚合物，例如，冻干多糖、糖蛋白类、弹性蛋白、蛋白聚糖、明胶、胶原和/或氧化再生纤维素(ORC)。第一组织补偿件26020和第二组织补偿件26022可包括至少一种治疗剂，例如药物活性剂或药物。
组织补偿件26020、26022可包括牢固的或基本上牢固的保护帽26024、26026。例如，第一保护帽26024可定位在第一组织补偿件26020的远侧末端处，并且第二保护帽26026可定位在第二组织补偿件26022的远侧末端处。保护帽26024、26026可阻止或限制组织补偿件26020、26022的过早变形。例如，当组织补偿件26020、26022例如移动穿过套管针和/或围绕患者组织进行操作时，保护帽26024、26026可保护组织补偿件26020、26022。相似地，参见图174，端部执行器12可包括可释放地固定到下钳口25070中的钉仓25000的第一组织补偿件25020、以及可释放地固定到砧座25060的第二组织补偿件25022。根据本发明，可将保护帽25026定位在第二组织补偿件25022的远侧末端处。可将保护帽25026定位成邻近组织补偿件25022的可变形/弹性部分。保护帽25026可在组织补偿件25022之上和/或周围延伸，使得保护帽25026保护组织补偿件25022的远侧末端和中间部分。
参见图175-202，套管27010能够接合例如外科器械的端部执行器12的砧座25060。套管27010可包括分叉部27040(图176-179)、鼻部27080(图186-189)和补偿件27120(图180-182)。套管27010能够在平移击发杆25052(图196)接近侧末端部执行器12的远侧末端时释放补偿件27020。补偿件27020可为可变形的和/或弹性的，这类似于本文所述的至少一个组织厚度补偿件。例如，补偿件27020可包括聚合物组合物，例如可生物吸收的生物相容性弹性体聚合物。补偿件27020还可包括可生物吸收的聚合物，例如，冻干多糖、糖蛋白类、弹性蛋白、蛋白聚糖、明胶、胶原和/或氧化再生纤维素(ORC)。补偿件27020可包括至少一种治疗剂，例如药物活性剂或药物。主要参见图175，可将分叉部27040定位在砧座25060的外表面25061之上和/或周围。可将套管27010的鼻部27080定位在砧座25060的远侧部分处和/或周围。可将补偿件27020定位在砧座25060的内表面之上和/或周围。
仍参见图175，分叉部27040可包括至少一个叉27042a。任选地，如图505-508所示，分叉部27040可包括第一叉27042a和第二叉27042b。例如，叉27042a、27042b可为对称的或者基本上对称的。第一叉27042a可相对于第二叉27042b为对称的。第一叉27042a和/或第二叉27042b可在其远侧末端处变窄。例如，每个叉27042a、27042b可包括狭窄末端27048。主要参见图178，分叉部27040可例如为成轮廓的。再次参见图175，分叉部27040的轮廓可例如匹配或者基本上匹配砧座25060的外表面25061的轮廓。主要参见图178和图179，分叉部27040还可包括从第一叉27042a延伸的至少一个扣件27044a。第一扣件27044a可定位在分叉部27040的第一侧，并且第二扣件27044b可定位在分叉部27040的第二侧。扣件27044a、27044b可例如定位在分叉部27040的近侧末端处或附近。扣件27044a、27044b可例如沿着第一叉27042a和/或第二叉27042b定位在分叉部27040的远侧末端处或附近。扣件27044a、27044b可沿着分叉部27040的较长长度和/或分叉部27040的较短长度延伸。例如，多个扣件27044a、27044b可沿着分叉部的每一纵向侧进行定位。主要参见图179，第一扣件27044a可包括第一扣件延伸件27046a和/或第二扣件27044b可包括第二扣件延伸件27046b。例如，第一扣件延伸件27046a可从扣件27044a的至少一部分突出，并且第二扣件延伸件27046b可从扣件27044b的至少一部分突出。此外，第一扣件延伸件27046a和第二扣件延伸件27046b各自能够接合补偿件27020中的间隙27128(图181)，如本文更详细地描述。
现在参见图201，用于套管27010的补偿件27020可包括纵向突起27024和位于补偿件27020的每一纵向侧的边缘27026。可将补偿件27020定位成邻近邻砧座25060的内表面25063。另外，当将套管27010定位在砧座25060上时，纵向突起27024可基本上对齐砧座25060中的纵向狭槽25062并且/或者定位在砧座25060中的纵向狭槽25062内。补偿件27020的边缘27026可朝着外表面25061至少部分地包绕砧座25060。主要参见图180-181，用于套管27110的补偿件27120可包括主体27122，所述主体27122具有沿其至少一部分延伸的纵向突起27124。例如，纵向突起27124可限定沿主体27122的中线的纵向路径。当将套管27110定位在砧座25060上时，纵向突起27124可被砧座25060中的纵向狭槽25062(图201)接收。主要参见图182，纵向突起27124可包括圆形突出部。例如，纵向突起27124的横截面可形成弧和/或部分圆环。作为另外一种选择，纵向突起27124可包括有角的和/或阶梯状的突出部。补偿件27120还可包括边缘27126，所述边缘27126可为例如直的、弯曲的、有凹槽的、波浪形的、和/或之字形的。边缘27126可包括间隙27128，所述间隙27128能够在组装的套管27110定位在砧座25060上时接收扣件延伸件27046a、27046b(图179)。扣件延伸件27046a、27046b可配合穿过间隙27128以接合砧座25060，使得扣件延伸件27046a，27046b例如有助于将套管27110固定到砧座25060。
主要参见图183-185，用于套管27210的补偿件27220可包括主体27222，所述主体27222包括沿其至少一部分延伸的纵向突起27224。任选地，与上文相似，当将套管27210定位在砧座25060上时，纵向突起27224可被砧座25060中的纵向狭槽25062(图202)接收。主要参见图185，纵向突起27224可包括有角的突出部，使得突出70224的横截面形成基本上矩形的形状。补偿件27220还可包括边缘27226，所述边缘27226可为例如直的、弯曲的、有凹槽的、波浪形的、和/或之字形的。边缘27226可包括间隙27228，所述间隙27228能够在组装的套管27210定位在砧座25060上时接收扣件延伸件27046a、27046b(图179)。扣件延伸件27046a、27046b可配合穿过间隙27228并且接合砧座25060，使得扣件延伸件27046a，27046b例如有助于将套管27210固定到砧座25060。补偿件27220还可包括横贯补偿件27220的主体27222的多个肋27229。当将套管27210定位在砧座25060并且/或者当补偿件27220接触组织时，肋27229可支撑补偿件27220的主体27222。
参见图386-390，套管27010的鼻部27080可包括对齐脊27082，所述对齐脊27082可与砧座25060中的纵向狭槽25062(图201)基本上对齐。当对齐脊27082与纵向狭槽25062对齐时和当套管27010定位在砧座25060上时，鼻部27082可至少部分地包围套管27010的分叉部27040的远侧部分。例如，当将套管27010定位在砧座25060上时，每个叉27042a、27042b的狭窄末端27048可定位在鼻部27080内。如本文更详细地描述，当将分叉部27042与鼻部27080接合时，鼻部27080可使叉27042a、27042b以彼此更靠近和/或向下的方式挠曲。此外，如图190所示，当将分叉部27040的狭窄末端27048定位在鼻部27080内时，分叉部27040上的扣件27044a、27044b可接合例如补偿件27020的边缘27026。由于这种接合，可将补偿件27010固定到砧座25060。
参见图191-195，当鼻部27080与套管27010的分叉部27040接合时，可将补偿件27020固定到砧座25060。当击发杆25050沿着砧座25060中的纵向狭槽25062的一部分平移时，鼻部27080可保持与分叉部27040接合。现在参见图195-200，当击发杆25050上的切割元件25052和/或击发杆25050的任何其他合适部分(例如，保持凸缘25054)接近砧座25060的远侧末端时，击发杆25050可使鼻部27080与分叉部27040分离。击发杆25050可例如接触鼻部27080并且将鼻部27080推离砧座25060，使得鼻部27080与套管27010的分叉部27040分离。现在参见图202，当鼻部27080与分叉部27040分离时，第一叉27042a和第二叉27042b能够挠曲远离砧座25060。例如，当分叉部27070与鼻部27080接合时，叉27042a、27042b可朝向砧座25060以彼此更靠近和/或向下的方式进行挠曲并且可通过鼻部27080保持在这种位置。可通过鼻部27080将叉27042a、27042b保持在弹簧负荷下，使得叉27042a、27042b在鼻部27080一旦与叉27042a、27042b分离，就试图回弹到中立构型。作为另外一种选择，叉27042a、27042b可为充分变形的，使得叉27042a、27042b在鼻部27080一旦与其分离，就可通过击发杆25050向外变形或扩展。当叉27042a、27042b移动远离砧座25060时，沿每个叉27042a、27042b的纵向侧的扣件27044a、27044b可脱离补偿件27020，这可允许从砧座25060释放补偿件27020。
参见图203-209，外科器械的端部执行器12例如能够接收端部执行器插入件28010。端部执行器插入件28010可包括补偿件主体28012和至少一个夹具28014a、28014b。端部执行器插入件28010可包括例如补偿件主体28012的近侧末端处的近侧夹具28014b、和补偿件主体28012的远侧末端处的远侧夹具28014a。主要参见图206，可将远侧夹具28014a在砧座25060的远侧末端处或附近固定到端部执行器12的砧座25060。例如，远侧夹具28014a可与砧座25060的纵向狭槽25062基本上对齐并且/或者可部分定位在砧座25060的纵向狭槽25062内。主要参见图207，可将近侧夹具28014b固定到端部执行器12的下钳口25070中的钉仓25000(图208)。可将近侧夹具28014b在钉仓25000的近侧末端处或附近固定到钉仓25000。例如，近侧末端夹具28014b可与钉仓25000中的纵向狭槽25004基本上对齐并且/或者可定位在钉仓25000中的纵向狭槽25004内。
现在参见图208和209，可将端部执行器插入件28010插入到外科器械的端部执行器12内。任选地，端部执行器插入件28010的至少一部分(例如，补偿件主体28012、远侧夹具28014a、和/或近侧夹具28014b)可例如为可变形的和/或弹性的。当将端部执行器插入件28010插入到端部执行器12内时，远侧和/或近侧夹具28014a、28014b可弯曲或挠曲。当夹具28014a、28014b例如挠曲时，夹具28014a、28014b例如可试图返回其初始未变形的构型并且可产生相应的回弹力或恢复力。任选地，当将端部执行器插入件28010定位在端部执行器12内时，端部执行器插入件28010可对端部执行器12施加弹簧负荷。端部执行器插入件28010可为固体的或基本上固体的，使得操作者在正将端部执行器插入件28010和钉仓25000插入到端部执行器12内时可抓紧插入件28010。
端部执行器插入件28010可在端部执行器12的切割和/或紧固操作之前来从端部执行器12移除。作为另外一种选择，端部执行器插入件28010可在切割和/或击发操作期间保持定位在端部执行器12中。例如，当钉从其钉仓25000中的钉腔25002(图207)击发时，可通过切割元件25052横切端部执行器插入件28010。端部执行器插入件28010可包括组织厚度补偿材料，这类似于本文所述的组织厚度补偿件中的至少一个。例如，端部执行器插入件28010可包括聚合物组合物，例如可生物吸收的生物相容性弹性体聚合物。端部执行器插入件28010还可包括可生物吸收的聚合物，例如，冻干多糖、糖蛋白类、弹性蛋白、蛋白聚糖、明胶、胶原和/或氧化再生纤维素(ORC)。端部执行器插入件28010可包括至少一种治疗剂，例如药物活性剂或药物。
参见图210-215，可将组织厚度补偿件29020定位在外科器械的端部执行器12中。组织厚度补偿件29020可基本上类似于本文所述的组织厚度补偿件中的至少一个。例如，组织厚度补偿件29020可为充分变形的和弹性的，使得组织厚度补偿件29020的变形产生回弹力或恢复力。主要参见图211，静电荷可将组织厚度补偿件29020吸引到端部执行器12的砧座25060，使得静电荷将组织厚度补偿件29020固定到砧座25060。可中和静电荷，使得砧座25060释放组织厚度补偿件29020。除此之外或作为另外一种选择，现在参见图212，可通过至少一个吸力元件29022来将组织厚度补偿件29020固定到砧座25060。例如，组织厚度补偿件29020的表面上的多个微吸力元件29022可将组织厚度补偿件29020可释放地固定到砧座25060。除此之外或作为另外一种选择，参见图213，钩-环紧固件29024可将组织厚度补偿件29020固定到砧座25060。例如，组织厚度补偿件29020的表面可包括多个钩紧固件29024a，并且砧座25060的表面可包括例如多个环紧固件29024b。钩紧固件29024a可接合环紧固件29024b，使得组织厚度补偿件29020可释放地固定到砧座25060。
除此之外或作为另外一种选择，现在参见图214，可通过带29026来将组织厚度补偿件29020固定到砧座25060。带29026可包括弹性体聚合物并且/或者可围绕砧座25060系结或打结。当从砧座25060移除带29026时，可从砧座25060释放组织厚度补偿件29020。为了有利于带29026的移除，其例如可进行拉伸和/或切割。根据本发明，多个带29026可将组织厚度补偿件29020固定到砧座25060。作为另外一种选择或除此之外，现在参见图215，可通过定位在组织厚度补偿件29020的远侧末端处的承套29028来将组织厚度补偿件29020固定到砧座25060。承套29028能够在其中接收例如砧座25060的远侧末端。组织厚度补偿件29020上的对齐边缘29029可与砧座25060中的纵向狭槽25062对齐并且/或者可定位在砧座25060中的纵向狭槽25062内。例如，当将组织厚度补偿件29020定位在砧座25060上和/或从砧座25060移除时，对齐边缘29029可在纵向狭槽25062内滑动。
参见图216-218，可将组织厚度补偿件30020定位在外科器械的端部执行器12的砧座25060上。组织厚度补偿件30020可包括主体30022和凹坑30024。例如，可将补偿件材料30026保持在主体30022和凹坑30024之间。补偿件材料30026可包括可生物吸收的聚合物，例如冻干多糖、糖蛋白类、弹性蛋白、蛋白聚糖、明胶、胶原和/或氧化再生纤维素(ORC)。除此之外或作为另外一种选择，补偿件材料30026可包括至少一种治疗剂，例如药物活性剂或药物。组织厚度补偿件30020可为可变形的和/或弹性的，这类似于本文所述的至少一个组织厚度补偿件。例如，组织厚度补偿件30020可包括聚合物组合物，例如可生物吸收的生物相容性弹性体聚合物。组织厚度补偿件30020还可包括可生物吸收的聚合物，例如，冻干多糖、糖蛋白类、弹性蛋白、蛋白聚糖、明胶、胶原和/或氧化再生纤维素(ORC)。
主要参见图217，组织厚度补偿件30020的主体30022可包括对齐元件30028，所述对齐元件30028可在组织厚度补偿件30020固定到砧座25060时接收在砧座25060的纵向狭槽25062内。主体30022可包括阶梯状厚度，使得主体30022的几何结构基本上相应于砧座25060的几何结构。另外，主体30022可包括纵向凸缘30029。例如，纵向凸缘30029可例如沿着组织厚度补偿件30020的主体30022的每个纵向侧延伸。纵向凸缘30029可至少部分地包绕砧座25060以将组织厚度补偿件30020固定到砧座25060。另外，例如，纵向凸缘30029可为充分弹性的，使得纵向凸缘30029可挠曲以适应和/或接合砧座25060。当凸缘30029接合砧座25060时，纵向凸缘30029可对砧座25060施加夹紧力。凹坑30024可包括凹痕30025。当将组织厚度补偿件30020固定到砧座25060时，可例如使凹痕30025与砧座25060中的纵向狭槽25062基本上对齐。组织厚度补偿件30020在凹痕30025处可较薄，使得平移切割元件25052(图207)在较薄位置处切断组织厚度补偿件30020。
现在参见图219和图220，组织厚度补偿件30120可包括主体30122，所述主体30122能够在其中保持补偿材料30026。组织厚度补偿件30120可包括对齐元件30128、凹痕30125、和/或纵向凸缘30129。组织厚度补偿件30120还可包括可在打开位置与闭合位置之间移动的闩锁30124。当闩锁30124处于闭合位置时，如图219所示，可将补偿材料30026包封在组织厚度补偿件30120的主体30122内，并且当闩锁30124处于打开位置时，如图220所示，补偿材料30026可从主体30122逸出。类似于本文所述的组织厚度补偿件中的至少一个，组织厚度补偿件30120可为可变形的和/或弹性的。例如，组织厚度补偿件30120可包括聚合物组合物，例如可生物吸收的生物相容性弹性体聚合物。组织厚度补偿件30120还可包括可生物吸收的聚合物，例如，冻干多糖、糖蛋白类、弹性蛋白、蛋白聚糖、明胶、胶原和/或氧化再生纤维素(ORC)。由于组织厚度补偿件30120的弹性，主体30122的至少一部分可进行挠曲以使闩锁30124在打开位置和闭合位置之间移动。当从外科部位移除砧座时，组织厚度补偿件30120的主体30122可保持附接到砧座。例如，主体30122能够撕裂以离开其中可已经捕获主体30122的任何钉。
参见图221，组织厚度补偿件30220可包括主体30222和凹坑30224。例如，可将补偿件材料30026保持在主体30222和凹坑30224之间。组织厚度补偿件30220可包括对齐元件、凹痕和/或纵向凸缘30229。此外，至少一个纵向凸缘30229可包括沟槽或狭槽30228，所述沟槽或狭槽30228能够接收从组织厚度补偿件30220的凹坑30224延伸的插片30225。在这种情况下，沟槽30228与插片30225的接合可连接主体30222和凹坑30224。此外，在这种情况下，沟槽30028与插片30025的连接可将补偿材料30026包封和/或保持在组织厚度补偿件30220内。现在参见图222a，组织厚度补偿件30320的凹坑30324可包括从其延伸的锚定件30325。此外，组织厚度补偿件30320可包括具有开口30328的主体30322。锚定件30325可从凹坑30324延伸以接合主体30322中的开口30328。在这种构型中，凹坑30324和主体30222可包封两者间的补偿材料30026。组织厚度补偿件30320还可包括一个或多个凸缘30229，所述一个或多个凸缘30229可安装到砧座以便将主体30322保持到砧座。
现在参见图223，组织厚度补偿件30420可包括主体30422和凹坑30424。可将补偿材料30026保持在组织厚度补偿件30420的主体30422和凹坑30424之间。主体30422可包括孔口30428，并且凹坑30424可包括锚定件30425。例如，锚定件30425可从凹坑30424并且穿过主体30422的孔口30428延伸。例如，当将组织厚度补偿件30420固定到砧座25060时，锚定件30425可接合砧座25060。锚定件30525可为充分可变形的和弹性的，使得锚定件30425在接合砧座25060时挠曲。此外，挠曲的锚定件30425可对砧座25060施加夹紧力以将组织厚度补偿件30420固定或辅助固定到砧座25060。作为另外一种选择，锚定件可未完全延伸穿过补偿件主体中的孔口。参见图224，组织厚度补偿件30520的凹坑30524上的锚定件30525可接合组织厚度补偿件30520的主体30522中的孔口30528。锚定件30525可接合孔口30528以将凹坑30524固定到主体30522。例如，孔口30528可包括延伸到承窝的颈缩部分。锚定件30525可包括固定边缘，所述固定边缘可穿过颈缩部分并且接合承窝以将锚定件20525固定在孔口30528内。例如，组织厚度补偿件30520还可包括对齐元件、凹痕和/或纵向凸缘30529。
参见图225-227，组织厚度补偿件31020能够接合外科器械的端部执行器31012的砧座31060。组织厚度补偿件31020可包括外膜31022、内膜31024、以及定位在两者间的补偿材料31026。组织厚度补偿件31020可为可变形的和/或弹性的，这类似于本文所述的组织厚度补偿件中的至少一个。例如，补偿材料31026可包括聚合物组合物，例如可物吸收的生物相容性弹性体聚合物。组织厚度补偿件31020还可包括可生物吸收的聚合物，例如，冻干多糖、糖蛋白类、弹性蛋白、蛋白聚糖、明胶、胶原和/或氧化再生纤维素(ORC)。组织厚度补偿件31020可包括至少一种治疗剂，例如药物活性剂或药物。组织厚度补偿件31020的补偿材料31206可包括治疗剂。
例如，可将内膜31024定位成邻近砧座31060中的钉成形凹坑31066。主要参见图225，内膜31024可包括阶梯状几何形状，使得内膜31024的几何形状基本上对应于砧座31060的几何形状。内膜31024还可包括对齐脊31028，所述对齐脊31028可例如与砧座31060中的纵向狭槽31062基本上对齐和/或平行。如本文更详细地描述，内膜31024可包括从内膜31024的每个纵向侧延伸并且端接在扣件31027中的内凸缘31025。外膜31022可包括例如主体31021和至少一个外凸缘31023。任选地，例如，外凸缘31023可从主体31021的每个纵向侧延伸。可将外凸缘31023固定到内凸缘31025，使得补偿材料31026保持在外膜31022和内膜31024之间。
主要参见图227，砧座31060可包括外表面31061和沿着外表面31061的至少一部分的至少一个沟槽31064。根据本发明，可将内膜31024a的内凸缘31025上的扣件31027定位在沟槽31064内。参见图226，例如，组织厚度补偿件31020可围绕砧座31060进行滑动。砧座31060上的沟槽31064可延伸到砧座31060的远侧末端。在此类情况下，组织厚度补偿件31020的扣件31027可在沟槽31064内并且沿着组织厚度补偿件31020的长度滑动。
现在参见图228和图229，组织厚度补偿件31120可包括补偿材料31026和至少一个连接件31124。每个连接件31124可围绕补偿材料31026延伸并且可在其相对末端端接在扣件31127中。可将扣件31127定位在砧座31060的沟槽31064内以将组织厚度补偿件31120紧固到砧座31060。砧座31060上的沟槽31164可延伸到砧座31060的远侧末端。在此类情况下，连接件31124的扣件31127可滑动到沟槽31064内。作为另外一种选择，连接件31224可为弹性的，使得它们可围绕砧座31060挠曲和卡扣。在使用期间，连接件31224可将补偿材料31026保持在适当的位置，直至补偿材料31026与砧座31060分离。在某些情况下，连接件31224可保持附接到砧座31060并且可与砧座一起从外科部位移除。在某些其他情况下，连接件31224可与砧座31060分离并且可与补偿材料31026一起被植入。
参见图230-236，组织厚度补偿件32020可包括主体部分32022、至少一个纵向凸缘32024、和至少一个凹坑32026。组织厚度补偿件31020可为可变形的和/或弹性的，这类似于本文所述的组织厚度补偿件中的至少一个。例如，补偿材料31026可包括聚合物组合物，例如可生物吸收的生物相容性弹性体聚合物。组织厚度补偿件31020还可包括可生物吸收的聚合物，例如，冻干多糖、糖蛋白类、弹性蛋白、蛋白聚糖、明胶、胶原和/或氧化再生纤维素(ORC)。纵向凸缘32024可沿主体部分32022的每个纵向侧延伸。主要参见图233，组织厚度补偿件32020的纵向凸缘32024能够接合砧座25060。例如，组织厚度补偿件32020可滑动到砧座25060和纵向凸缘32024上，并且可至少部分地包绕砧座25060的一部分。在此类情况下，例如，凸缘32024可将组织厚度补偿件32020固定到砧座25060。任选地，当将组织厚度补偿件32020固定到砧座时，组织厚度补偿件32020的主体部分32022可与砧座25060表面上的钉成形凹坑25066重叠。
对上文进行进一步描述，多个凹坑32026可横向地横贯主体部分32022。主要参见图234，多个凹坑32026可包括至少一种治疗剂，例如药物活性剂或药物。根据本发明，多个第一凹坑32026a可包括第一治疗剂或其组合，并且多个第二凹坑32026b可包括第二治疗剂或其组合。第一凹坑32026a和第二凹坑32026b可例如沿着主体部分32022交替地进行定位。此外，当从第一凹坑32026a释放第一治疗剂并且从第二凹坑32026b释放第二治疗剂时，第一治疗剂和第二治疗剂能够彼此发生反应。参见图236，例如，当击发杆25050上的切割元件25052沿着砧座25060中的纵向狭槽25062平移时，凹坑32026可释放保持在其中的治疗剂。
现在参见图237，外科缝合器械的端部执行器可包括砧座32560和具有组织厚度补偿件32520的钉仓32500。与上文相似，钉仓32500可包括至少部分地容纳于其中的多个钉32530，所述多个钉32530可从钉仓射出以在其中捕获组织厚度补偿件32520。另外与上文相似，钉32530可穿透组织厚度补偿件32520并且接触限定于砧座32560中的钉成形凹坑32562。现在参见图239，砧座32560还可包括与其附接的层32570，所述层32570能够将组织厚度补偿件32580保持到砧座32560。例如，层32570可包括充电层，所述充电层能够保持和/或产生静电荷并且吸引组织厚度补偿件32580。更具体地讲，范德瓦尔斯分子力(无论主动致动还是被动致动)例如可将组织厚度补偿件32580保持到层32570。充电层32570可与外科缝合器械的柄部电连通，所述柄部可包括控制件，所述控制件能够使充电层32570与电源选择性地联接并且因此允许在充电层32570内选择性地产生静电荷。例如，充电层32570可包括例如嵌入在聚合物内的导电电极。在任何情况下，静电层32570可吸引组织厚度补偿件32580中的带相反电荷的颗粒，并且将组织厚度补偿件32580保持到砧座。现在参见图238，充电层32570可包括彼此电连通的导体32571的网格或栅格。例如，导体可被定位和布置成使得它们围绕限定于砧座32560中的钉成形凹坑32562。在此类情况下，钉32530可从钉仓32500射出，随后可通过砧座32560进行变形，且不会在其中捕获导体32571。在各种情况下，可在钉32530已与组织厚度补偿件32580接合之后，使充电层32570与电源断开，以使得层32570中的静电荷可耗散。在某些其他情况下，可在钉32530正被击发之前来使充电层32570与电源断开。在任何情况下，当静电荷耗散时，可重新打开砧座32560并且可将层32570移动远离组织厚度补偿件32580。静电荷可需要在层32570可从组织厚度补偿件32580分离之前完全耗散，而作为另外一种选择，层32570可在层32570中的静电荷已完全耗散之前从组织厚度补偿件32580分离。由于上文所述，可在不使用化学粘合剂的情况下来将组织厚度补偿件32580附接到砧座32560。
对上文进行进一步描述，层32570还可为外科缝合器械的柄部提供反馈能力。例如，层32570可为压敏的并且能够通过例如砧座32560来检测正对其施加的夹紧压力。
对上文进行进一步描述，组织厚度补偿件可由生物相容性材料构成。生物相容性材料(例如，泡沫)可包括增粘剂、表面活性剂、填料、交联剂、颜料、染料、抗氧化剂、和其它稳定剂、和/或它们的组合，从而为材料提供所需的特性。生物相容性泡沫可包括表面活性剂。表面活性剂可施用到材料的表面和/或可分散在材料内。不受任何具体理论的束缚，施用到生物相容性材料的表面活性剂可降低接触材料的流体的表面张力。例如，表面活性剂可降低接触材料的水的表面张力，以促进水渗透到材料内。水可充当催化剂。表面活性剂可增加材料的亲水性。
表面活性剂可包括阴离子表面活性剂、阳离子表面活性剂、和/或非离子表面活性剂。表面活性剂例子包括但不限于聚丙烯酸、methalose、甲基纤维素、乙基纤维素、丙基纤维素、羟乙基纤维素、羧甲基纤维素、聚氧乙烯鲸蜡基醚、聚氧乙烯月桂基醚、聚氧乙烯辛基醚、聚氧乙烯辛基苯基醚、聚氧乙烯油基醚、聚氧乙烯山梨糖醇单月桂酸酯、聚氧乙烯硬脂基醚、聚氧乙烯壬基苯基醚、二烷基苯氧基聚(乙烯氧)乙醇、泊洛沙姆、以及它们的组合。表面活性剂可包括聚乙二醇和聚丙二醇的共聚物。表面活性剂可包括磷脂表面活性剂。磷脂表面活性剂可提供抗菌稳定特性，并且/或者可将其它材料分散在生物相容性材料中。
组织厚度补偿件可包括至少一种药物。组织厚度补偿件可包括本文所述的天然材料、非合成材料、和/或合成材料中的一种或多种。组织厚度补偿件可包括生物相容性泡沫，所述生物相容性泡沫包含明胶、胶原、透明质酸、氧化再生纤维素、聚乙醇酸、聚己内酯、聚乳酸、聚二氧杂环己酮、多羟基链烷酸酯、聚卡普隆、以及它们的组合。组织厚度补偿件可包括含有至少一种药物的膜。组织厚度补偿件可包括含有至少一种药物的可生物降解膜。药物可包括液体、凝胶、和/或粉末。药物可包括抗癌药，例如，顺铂、丝裂霉素、和/或阿霉素。
组织厚度补偿件可包含生物降解材料，以在生物降解材料降解时提供至少一种药物的受控洗脱或释放。当可生物降解材料接触激活剂(例如，激活剂流体)时，可生物降解材料可降解、可分解、或损失结构完整性。激活剂流体可包括例如盐水溶液或任何其它电解质溶液。可生物降解材料可通过常规技术(包括但不限于喷涂、浸渍、和/或刷涂)来接触激活剂流体。使用时，例如，外科医生可将包括含至少一种药物的组织厚度补偿件的端部执行器和/或钉仓浸渍到激活剂流体(包括盐溶液，例如，氯化钠、氯化钙、和/或氯化钾)内。当组织厚度补偿件降解时，组织厚度补偿件可释放药物。药物从组织厚度补偿件的洗脱或释放可由快速的初始洗脱或释放速率和较慢的持续洗脱或释放速率来表征。
根据本发明，组织厚度补偿件例如可由生物相容性材料构成，所述生物相容性材料可包括氧化剂。氧化剂可为有机过氧化物和/或无机过氧化物。氧化剂的例子可包括但不限于过氧化氢、过氧化脲、过氧化钙、和过氧化镁、以及过碳酸钠。氧化剂可包括过氧基氧化剂和次氯酸基氧化剂，例如，过氧化氢、次氯酸、次氯酸盐、hypocodites和过碳酸盐。氧化剂可包括碱金属亚氯酸盐、次氯酸盐和过硼酸盐，例如，亚氯化钠、次氯酸钠和过硼酸钠。氧化剂可包括钒酸盐。氧化剂可包括抗坏血酸。氧化剂可包括活性氧生成物。根据本发明，组织支架可包括含氧化剂的生物相容性材料。
生物相容性材料可包括液体、凝胶、和/或粉末。氧化剂可包括例如微粒和/或纳米颗粒。例如，可将氧化剂研磨成微粒和/或纳米颗粒。可通过使氧化剂悬浮于聚合物溶液中来将氧化剂掺入到生物相容性材料中。可在低压冻干过程中来将氧化剂掺入到生物相容性材料中。在低压冻干之后，氧化剂可附接到生物相容性材料的单元壁，以在接触时与组织相互作用。氧化剂可并非化学键合到生物相容性材料。可将过碳酸盐干粉嵌入在生物相容性泡沫内，以通过氧气的缓慢释放来提供长效生物效应。可将过碳酸盐干粉嵌入在具有非织造结构的聚合物纤维内，以通过氧气的缓慢释放来提供长效生物效应。生物相容性材料可包括氧化剂和药物，例如，强力霉素和抗坏血酸。
生物相容性材料可包括快速释放的氧化剂和/或较慢持续释放的氧化剂。氧化剂从生物相容性材料的洗脱或释放可由快速的初始洗脱或释放速率和较慢的持续洗脱或释放速率来表征。当氧化剂接触体液(例如，水)时，氧化剂可产生氧气。体液的例子可包括但不限于血液、血浆、腹膜液、脑脊髓液、尿液、淋巴液、滑液、玻璃体液、唾液、胃肠腔内容物、和/或胆汁。不受任何具体理论的束缚，氧化剂可降低细胞死亡、增强组织活力、并且/或者保持可在切割和/或缝合期间损害的组织-组织的机械强度。
生物相容性材料可包括至少一个微粒和/或纳米颗粒。生物相容性材料可包括本文所述的天然材料、非合成材料、和合成材料中的一种或多种。生物相容性材料可包括具有约10nm到约100nm和/或约10μm到约100μm(例如45-50nm和/或45-50μm)的平均直径的颗粒。生物相容性材料可包括生物相容性泡沫，所述生物相容性泡沫包括嵌入其中的至少一个微粒和/或纳米颗粒。微粒和/或纳米颗粒可并非化学键合到生物相容性材料。微粒和/或纳米颗粒可提供药物的受控释放。微粒和/或纳米颗粒可包括至少一种药物。微粒和/或纳米颗粒可包括例如止血剂、抗微生物剂、和/或氧化剂。组织厚度补偿件可包括生物相容性泡沫，所述生物相容性泡沫包括含氧化再生纤维素的止血剂、含强力霉素和/或庆大霉素的抗微生物剂、和/或含percarbant的氧化剂。微粒和/或纳米颗粒可提供例如至多三天的药物受控释放。
微粒和/或纳米颗粒可在制造过程期间嵌入到生物相容性材料中。例如，生物相容性聚合物(例如，PGA/PCL)可接触溶剂(例如，二氧杂环己烷)以形成混合物。生物相容性聚合物可进行研磨以形成颗粒。含有或不含有ORC颗粒的干燥颗粒可接触混合物以形成悬浮液。可冻干悬浮液以形成生物相容性泡沫，所述生物相容性泡沫包含PGA/PCL，所述PGA/PCL具有干燥颗粒和/或嵌入其中的ORC颗粒。
本文所公开的组织厚度补偿件或层可由例如可吸收聚合物构成。组织厚度补偿件可由例如以下物质构成：泡沫、膜、纤维织造物、纤维非织造物PGA、PGA/PCL(聚(乙醇酸-共-己内酯))、PLA/PCL(聚(乳酸-共-聚己内酯))、PLLA/PCL、PGA/TMC(聚(乙醇酸-共-三亚甲基碳酸酯))、PDS、PEPBO、或其它可吸收的聚氨酯、聚酯、聚碳酸酯、聚原酸酯、聚酐、聚酯酰胺、和/或聚含氧酸酯。根据本发明，组织厚度补偿件由例如PGA/PLA(聚(乙醇酸-共-乳酸))和/或PDS/PLA(聚(对-二氧环己酮-共-乳酸))构成。根据本发明，组织厚度补偿件可由例如有机材料构成。组织厚度补偿件可由例如羧甲基纤维素、藻酸钠、交联透明质酸、和/或氧化再生纤维素构成。根据本发明，组织厚度补偿件可包括例如3-7肖氏A硬度(30-50肖氏OO硬度)范围内的硬度计，其中最大刚度为15肖氏A硬度(65肖氏OO硬度)。组织厚度补偿件在3lbf负荷下可发生40％的压缩，在6lbf负荷下可发生60％的压缩，并且/或者在20lbf负荷下可发生80％的压缩。一种或多种气体(例如，空气、氮气、二氧化碳、和/或氧气)可被鼓入组织厚度补偿件中并且/或者可容纳在组织厚度补偿件内。组织厚度补偿件可在其中包括颗粒，所述颗粒可占构成组织厚度补偿件的材料硬度的大约50％至大于75％。
根据本发明，组织厚度补偿件可包括例如透明质酸、营养素、血纤维蛋白、凝血酶、富含血小板的血浆、柳氮磺吡啶(–5ASA+磺胺吡啶偶氮键))–前体药物–结肠细菌(偶氮还原酶)、氨水杨酸(具有用于延缓释放的不同前体药物结构的5ASA)、(5ASA+丙烯酸树脂-S涂布的–pH>7(涂层溶解))、(5ASA+乙基纤维素涂布的–时间/pH依赖型缓释)、(5ASA+丙烯酸树脂-L涂布的–pH>6)、奥沙拉嗪(5ASA+5ASA–结肠细菌(偶氮还原酶))、巴柳氮(5ASA+4氨基苯甲酰基-B-丙氨酸)-结肠细菌(偶氮还原酶))、粒状氨水杨酸、Lialda(氨水杨酸的缓释和SR制剂)、HMPL-004(可抑制TNF-α、白介素-1β、和核-k B激活的草本植物混合物)、CCX282-B(干扰T淋巴细胞运输到肠粘膜内的口服趋化因子受体拮抗剂)、利福昔明(不可吸收的广谱抗生素)、英夫利昔单抗、murine chymieric(靶向于TNF-α的单克隆抗体，所述TNF-α被核准用于降低迹象/症状、保持服用中等量/重度量苯巴比妥的成年/儿童患者的临床缓解、并且对不充分反应常规治疗的Crohn病造瘘)、阿达木单抗、人IgG1(抗-TNF-α单克隆抗体-被核准用于降低Crohn病的迹象/症状并且可用于降低和保持患有不充分反应常规治疗的中度/重度活性Crohn病或者不耐受英夫利昔单抗的成年患者的临床缓解)、Certolizumabpegoll、人化的抗-TNF FAB’(链接到聚乙二醇的单克隆抗体片段-被核准用于降低Crohn病的迹象/症状并且可用于降低和保持患有不充分反应常规治疗的中度/重度病的成年患者的反应)、那他珠单抗、第一非-TNF-α抑制剂(被核准用于Crohn病的生物化合物)、人化的单克隆IgG4抗体(靶向于α-4整联蛋白-被FDA核准用于诱导和保持患有存在炎症迹象的中度/重度疾病并且不充分反应或不能够耐受常规Crohn治疗和TNF-α抑制剂的患者的临床反应和缓解)、可能与英夫利昔单抗一起给药的伴随免疫调制剂)、硫唑嘌呤-6-巯嘌呤(嘌呤合成抑制剂-前体药物)、甲氨蝶呤(结合二氢叶酸还原(DHFR)酶，其参与四氢叶酸酯合成、抑制所有的嘌呤合成物)、别嘌呤醇和硫唑嘌呤治疗、PPI、用于酸抑制以保护愈合线的H2、C-Diff–Flagyl、万古霉素(粪便易位处理；有益菌种；正常腔内菌群的再增殖)、和/或利福昔明(细菌过度生长的治疗(显著地肝性脑病)；未被胃肠道吸收且不作用于管腔内细菌)。
如本文所述，组织厚度补偿件可例如补偿组织厚度的变化，所述组织被捕获在从钉仓射出的钉内和/或被容纳在钉线内。换句话讲，钉线内的某些钉可捕获组织的较厚部分，而钉线内的其它钉可捕获组织的较薄部分。在此类情况下，组织厚度补偿件可在钉内呈现不同的高度或厚度，并且可将压缩力施加到捕获在钉内的组织，而不管所捕获的组织厚还是薄。根据本发明，组织厚度补偿件可补偿组织硬度的变化。例如，钉线内的某些钉可捕获组织的高度压缩部分，而钉线内的其它钉可捕获组织的较低压缩部分。在此类情况下，组织厚度补偿件能够例如在已捕获具有较低压缩率或较高硬度的组织的钉内呈现较小的高度，并且相对应地，在已捕获具有较高压缩率或较低硬度的组织的钉内呈现较大的高度。在任何情况下，组织厚度补偿件例如无论是否补偿组织厚度变化和/或组织硬度变化均可称为例如“组织补偿件”和/或“补偿件”。
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、然后清洗或替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替换或移除该装置任意数目的特定零件或部分。清洗和/或替换特定部分后，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/替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，本文所述的本发明将在手术前得以处理。首先，获取新的或用过的装置，并在必要时对装置进行清洁。然后对装置进行消毒。在一种消毒技术中，将该装置置于闭合并密封的容器中，例如塑料或TYVEK袋中。然后将容器和装置置于能够穿透该容器的辐射区，例如γ辐射、x-射线或高能电子。辐射将装置上和容器中的细菌杀死。然后将灭菌后的装置保存在消毒容器中。该密封容器将器械保持无菌，直到在医疗设备中打开该容器。
以引用方式全文或部分地并入本文的任何专利、专利公开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的材料。如果据述以引用方式并入本文但与本文所述的现有定义、陈述或其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另外的修改。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、用途或适应型式。此外，本专利申请旨在涵盖本发明所属领域中出自已知或惯有实践范围内的背离本公开的型式。

Claims (18)

1.一种补偿件，其能够附接到紧固器械的砧座，其中所述砧座包括成形表面，并且其中所述补偿件包括：
可压缩的补偿件主体，其包括：
多个第一封包；和
多个第二封包，其中每个第二封包定位在两个或更多个第一封包中间；
定位在每个第一封包内的第一药物；
定位在每个第二封包内的第二药物，其中所述第一药物不同于所述第二药物；以及
能够附接到所述砧座的附接部分。
2.根据权利要求1所述的补偿件，其中所述第一药物包含第一粉末并且所述第二药物包含第二粉末。
3.根据权利要求1或权利要求2所述的补偿件，其中所述第一药物包含藻酸盐并且所述第二药物包含钙。
4.根据前述权利要求中任一项所述的补偿件，其中所述补偿件主体包括纵向轴线，并且其中所述第一封包和所述第二封包沿所述纵向轴线以交替布置方式布置。
5.根据前述权利要求中任一项所述的补偿件，其中所述第一封包和所述第二封包以交替布置方式布置。
6.根据前述权利要求中任一项所述的补偿件，其中所述第一药物包含非织造氧化再生纤维素。
7.一种与缝合器一起使用的缝合组件，所述缝合组件包括：
砧座，其包括：
多个成形表面；和
狭槽，所述狭槽中能够接收切割构件；
附接到所述砧座的补偿件，其中所述补偿件包括与所述狭槽对齐的多个第一封包和与所述狭槽对齐的多个第二封包，并且其中所述第一封包和所述第二封包能够被所述切割构件切割；
定位在每个第一封包内的第一药物；以及
定位在每个第二封包内的第二药物，其中所述第一药物不同于所述第二药物。
8.根据权利要求7所述的缝合组件，其中所述狭槽限定用于所述切割构件的路径，并且其中所述第一封包和所述第二封包沿横向于所述路径的方向延伸。
9.根据权利要求7或权利要求8所述的缝合组件，其中所述补偿件包括能够配合在所述狭槽内的附接部分，并且其中所述附接部分能够被所述切割构件切割。
10.根据权利要求7-9中任一项所述的缝合组件，其中所述第一药物包含第一粉末并且所述第二药物包含第二粉末。
11.根据权利要求7-10中任一项所述的缝合组件，其中所述第一药物包含藻酸盐并且所述第二药物包含钙。
12.根据权利要求7-11中任一项所述的缝合组件，其中所述第一封包和所述第二封包沿所述狭槽以交替布置方式布置。
13.一种与缝合器一起使用的缝合组件，所述缝合组件包括：
砧座，其包括：
多个成形表面；和
纵向狭槽；
能够在所述狭槽内运动的切割构件；
附接到所述砧座的补偿件，其中所述补偿件包括相对于所述狭槽侧向延伸的多个第一侧向腔体和相对于所述狭槽侧向延伸的多个第二侧向腔体，并且其中所述切割构件能够切割所述第一侧向腔体和所述第二侧向腔体；
定位在每个第一侧向腔体内的第一药物；以及
定位在每个第二侧向腔体内的第二药物，其中所述第一药物不同于所述第二药物。
14.根据权利要求13所述的缝合组件，其中所述补偿件包括能够配合在所述纵向狭槽内的附接部分，并且其中所述切割构件能够切割所述附接部分。
15.根据权利要求13或权利要求14所述的缝合组件，其中所述第一药物包含第一粉末并且所述第二药物包含第二粉末。
16.根据权利要求13-15中任一项所述的缝合组件，其中所述第一药物包含藻酸盐并且所述第二药物包含钙。
17.根据权利要求13-16中任一项所述的缝合组件，其中所述第一侧向腔体和所述第二侧向腔体沿所述纵向狭槽以交替布置方式布置。
18.根据权利要求13-17中任一项所述的缝合组件，其中所述纵向狭槽限定纵向轴线，并且其中所述第一侧向腔体和所述第二侧向腔体各自限定垂直于所述纵向轴线的侧向轴线。
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