CN104994798A - 可释放材料层和具有该可释放材料层的外科端部执行器 - Google Patents

可释放材料层和具有该可释放材料层的外科端部执行器 Download PDF

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CN104994798A
CN104994798A CN201480008056.XA CN201480008056A CN104994798A CN 104994798 A CN104994798 A CN 104994798A CN 201480008056 A CN201480008056 A CN 201480008056A CN 104994798 A CN104994798 A CN 104994798A
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material layer
end effector
slit
installed part
fastener cartridge
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CN104994798B (zh
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F·E·谢尔顿四世
J·S·斯韦兹
K·J·施密德
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Ethicon Endo Surgery Inc
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Ethicon Endo Surgery Inc
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Priority claimed from US13/097,954 external-priority patent/US10136890B2/en
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Abstract

本发明公开了一种与外科器械一起使用的端部执行器组件(5400)。该端部执行器组件可包括紧固件仓(5402)、多个紧固件、第一连接器(5480a)、第二连接器(5480b),以及通过第一连接器并通过第二连接器可释放地固定至紧固件仓的材料层(5468)。该材料层可具有安装件(5460),当材料层被固定到紧固件仓时,安装件(5460)延伸到紧固件仓中的位于第一连接器和第二连接器之间的狭槽或凹口(5456)中。材料层可为支撑材料和/或组织厚度补偿件。另外,材料层可具有加强特征结构和/或围绕其周边的至少一部分的圆齿状边缘。

Description

可释放材料层和具有该可释放材料层的外科端部执行器
相关申请的交叉引用
本非临时性专利申请为根据35U.S.C.§120的2008年2月15日提交的名称为“SURGICAL END EFFECTOR HAVING BUTTRESS RETENTIONFEATURES”的美国专利申请序列号12/032,002(现在为美国专利公布2009/0206143)的部分继续申请,该专利的全部公开内容以引用方式并入本文。
背景技术
本发明涉及外科器械,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。
附图说明
通过结合附图参考本发明示例性实施例的以下说明,本发明的特征和优点及其获取方法将会变得更加显而易见,并且可更好地理解发明本身,其中:
图1为根据本发明的一个非限制性实施例的附接到外科器械的远侧端部的端部执行器组件的透视图;
图2为根据本发明的一个非限制性实施例的包括至少一片支撑材料的端部执行器组件的透视图,其中所述端部执行器组件处于打开构型;
图3为图2的端部执行器组件的钉仓的透视图,其中支撑材料可释放地保持到其上;
图4为移除了一些部件的端部执行器组件的局部透视图,其中所述端部执行器组件包括被构造成能够可释放地保持至少一片支撑材料的可回缩构件;
图5为图2的端部执行器组件的砧座的透视图,其中该砧座具有可释放地保持到其上的至少一片支撑材料;
图6为根据本发明的一个非限制性实施例的包括钉仓和砧座的端部执行器组件的分解图;
图7为移除了一些部件的图6的端部执行器组件的分解图;
图8为钉仓和支撑材料片的分解透视图,其中支撑材料片包括从其延伸的多个构件;
图9为根据本发明的一个非限制性实施例的支撑材料片的剖视图,该支撑材料片包括与钉仓的钉腔接合的构件;
图10为图9的分解图,示出了根据本发明的一个非限制性实施例的与钉仓的钉腔分开的构件;
图11为外科缝合器械的柄部组件的分解透视图;
图12为图11中所示的外科缝合器械的侧剖视图,示出了处于未致动位置的柄部组件;
图13为图11中所示的外科缝合器械的一部分的分解透视图;
图14为图12中所示的细节指示区的放大图;
图15为可与图11中所示的外科缝合器械一起使用的非关节运动一次性加载单元的透视图;
图16为可与图11中所示的外科缝合器械一起使用的关节运动一次性加载单元的透视图;
图17为可与图11的外科缝合器械一起使用的一次性加载单元的透视图;
图18为可与图11的外科缝合器械一起使用的一次性加载单元的另一个透视图;
图19为与图11的外科缝合器械一起使用的端部执行器的分解透视图;
图20为与图11中所示的外科缝合器械一起使用的钉仓的远侧端部的放大透视图;
图21为沿着图20中所示的剖面线截取的侧剖视图;
图22为图20中所示的钉仓的底部透视图;
图23为图21中所示的致动滑动件、推动器和紧固件的放大透视图;
图24为图17中所示的安装到近侧外壳部分的远侧端部部分的一次性加载单元的安装组件的放大透视图;
图25为图17中所示的移除了上半部外壳的一次性加载单元的近侧外壳部分和安装组件的放大透视图;
图26为图17中所示的移除了上半部外壳的一次性加载单元的近侧外壳部分和安装组件的透视图;
图27为部件分开的轴向驱动组件的透视图;
图28为图11中所示的外科缝合装置的透视图,其中图17的一次性加载单元从其脱离;
图29为图1的外科缝合器械的另一个透视图;
图30为与图29的外科缝合器械一起使用的端部执行器组件的分解图;
图31为图30的端部执行器组件的钉仓部分的透视图;
图32为与图29的外科缝合器械一起使用的端部执行器的局部透视图;
图33为图32的端部执行器的局部细部图;
图33A为根据各种实施例的缝合器械的端部执行器的分解透视图,该端部执行器包括钉仓和组织厚度补偿件;
图34为根据各种实施例的紧固至组织的组织厚度补偿件的透视图;
图35为根据各种实施例的组织厚度补偿件的局部剖视图,该组织厚度补偿件包括多个开口和多个腔;
图36为根据各种实施例的组织厚度补偿件的透视图,该组织厚度补偿件包括金字塔形防滑钉;
图37为图36中的组织厚度补偿件的剖视图;
图38为根据各种实施例的波纹形组织厚度补偿件的透视图;
图39为图38中的组织厚度补偿件的剖视图;
图40为根据各种实施例的组织厚度补偿件的透视图,该组织厚度补偿件包括圆齿状外边缘;
图41为根据各种实施例的组织厚度补偿件的透视图,该组织厚度补偿件包括圆齿状外边缘;
图42为根据各种实施例的组织厚度补偿件的透视图,该组织厚度补偿件包括缓冲构件;
图43为图42中的组织厚度补偿件的剖视图;
图44为根据各种实施例的紧固至组织的图42的组织厚度补偿件的剖视图;
图45为根据各种实施例的组织厚度补偿件的透视图,该组织厚度补偿件包括卷曲外边缘;
图46为图45中的卷曲外边缘的局部剖视图;
图47为根据各种实施例的缝合器械的端部执行器的分解透视图,该端部执行器包括钉仓和组织厚度补偿件;
图48为根据各种实施例的图47中的组织厚度补偿件的剖视图;
图49为根据各种实施例的组织厚度补偿件的顶视图,该组织厚度补偿件包括多个圆形片;
图50为根据各种实施例的组织厚度补偿件的顶视图,该组织厚度补偿件包括多个圆形片;
图51为根据各种实施例的组织厚度补偿件的剖视图;
图52为根据各种实施例的组织厚度补偿件的顶视图;
图53为根据各种实施例的组织厚度补偿件的顶视图,该组织厚度补偿件包括多个六边形片;
图54为根据各种实施例的紧固组织厚度补偿件的顶视图,该紧固组织厚度补偿件包括多个片;
图55为根据各种实施例的组织厚度补偿件的顶视图,该组织厚度补偿件包括多个狭缝;
图55A为根据各种实施例的缝合器械的端部执行器的分解透视图,该端部执行器包括钉仓和组织厚度补偿件;
图55B为根据各种实施例的紧固至组织的组织厚度补偿件的剖视图;
图56为根据各种实施例的组织厚度补偿件的透视图;
图57为图56中的组织厚度补偿件的细部图;
图58为至少部分地彼此重叠的两个层的平面图;
图59为使用图58中所示的层中的一个层的钉仓的透视图;
图60为被构造成能够结合钉仓使用的层的透视图;
图60A为图60的附接到钉仓的层的透视图;
图60B为至少部分地彼此重叠的相邻层的细部图;
图61为包括仓体和层组件的钉仓组件的分解图,该层组件包括第一层和第二层;
图62为通过来自图61的钉仓组件的击发钉而捕获在层组件之间的组织T的侧视图;
图63为图61的层组件的剖视图,示出第一层和第二层;
图64为根据本公开的各种实施例的与端部执行器组件一起使用的紧固件仓组件的透视图,示出了从紧固件仓组件的仓体被释放的材料层;
图65为各种元件从其移除的图64的紧固件仓组件的正视图,示出了材料层通过近侧连接器并通过远侧连接器被固定到仓体,并且进一步示出了处于非击发位置的击发组件;
图66为各种元件从其移除的图64的紧固件仓组件的正视图,示出了材料层通过远侧连接器被固定到仓体,并且进一步示出了处于部分击发位置的击发组件;
图67为根据本公开的各种实施例的与端部执行器组件一起使用的紧固件仓组件的透视图,示出了材料层从紧固件仓组件的仓体被释放;
图68为图67的紧固件仓组件的透视图,示出了材料层通过近侧连接器并通过远侧连接器被固定到仓体;
图69为沿图68中指示的平面截取的图67的紧固件仓组件的剖面透视图,示出了材料层通过近侧连接器被固定到仓体;
图70为沿图68中指示的平面截取的图67的材料层的剖面正视图;
图71为根据本公开的各种实施例的与端部执行器组件一起使用的材料层的剖面正视图;
图72为根据本公开的各种实施例的与端部执行器组件一起使用的紧固件仓组件的透视图,示出了材料层从紧固件仓组件的仓体被释放;
图73为图72的紧固件仓组件的透视图,示出了材料层通过第一连接器并通过第二连接器被固定到仓体;
图74为沿图73中指示的平面截取的图72的紧固件仓组件的剖面透视图,示出了材料层通过图73的近侧连接器被固定到仓体;
图75为沿图73中指示的平面截取的图72的材料层的剖面正视图;
图76为根据本公开的各种实施例的与端部执行器组件一起使用的紧固件仓组件的透视图,示出了材料层从紧固件仓组件的仓体被释放;
图77为图76的紧固件仓组件的透视图,示出了材料层通过近侧连接器并通过远侧连接器被固定到仓体;
图78为根据本公开的各种实施例的与端部执行器组件一起使用的紧固件仓组件的透视图,示出了材料层从紧固件仓组件的仓体被释放;
图79为图78的紧固件仓组件的剖面正视图,示出了材料层被固定到仓体;
图80为图78的紧固件仓组件的剖面透视图,示出了材料层被固定到仓体;
图80A为根据本公开的各种实施例的与端部执行器组件一起使用的材料层的透视图;
图80B为图80A的材料层的透视图;
图81为根据本公开的各种实施例的端部执行器组件的钳口的局部透视图,示出了材料层通过远侧连接器被固定到仓体,并且进一步示出了处于预致动位置的致动器;
图82为图81的钳口的局部透视图,示出了抵靠致动器的释放止动件的击发组件,示出了处于致动位置的致动器,并且进一步示出了通过致动器断裂的远侧连接器;
图83为图81的钳口的局部透视图,示出了致动器的通过击发组件断裂的释放止动件,并且进一步示出了击发组件的在释放止动件远侧的支脚;
图84为通过击发组件断裂的图83的释放止动件的详细透视图;
图85为根据本公开的各种实施例的端部执行器组件的钳口的透视图,该钳口具有从其移除的各种元件,示出了处于预致动位置的致动器,并且进一步示出了远侧连接器;
图86为图85的钳口的局部透视图,示出了处于致动位置的致动器,并且进一步示出了通过致动器断裂的远侧连接器;
图87为根据至少一个实施例的钉仓和组织厚度补偿件的分解图;
图88A为图87的钉仓和组织厚度补偿件的剖视图,示出了由钉驱动器支撑的未成形钉;
图88B为由成形钉捕获的图87的组织厚度补偿件的剖视图;
图88为根据至少一个实施例的组织厚度补偿件的剖视图;
图89为根据至少一个实施例的组织厚度补偿件的剖视图;并且
图90为根据至少一个实施例的组织厚度补偿件的剖视图。
具体实施方式
本申请的申请人还拥有以下美国专利申请,这些专利申请的每个都各自全文以引用的方式并入本文:
名称为“SURGICAL INSTRUMENTS WITH RECONFIGURABLESHAFT SEGMENTS”的美国专利申请序列号12/894,311(现为美国专利公布2012/0080496);
名称为“SURGICAL STAPLE CARTRIDGES SUPPORTING NON-LINEARLY ARRANGED STAPLES AND SURGICAL STAPLINGINSTRUMENTS WITH COMMON STAPLE-FORMING POCKETS”的美国专利申请序列号12/894,340(现为美国专利公布2012/0080482);
名称为“JAW CLOSURE ARRANGEMENTS FOR SURGICALINSTRUMENTS”的美国专利申请序列号12/894,327(现为美国专利公布2012/0080499);
名称为“SURGICAL CUTTING AND FASTENING INSTRUMENTSWITH SEPARATE AND DISTINCT FASTENER DEPLOYMENT ANDTISSUE CUTTING SYSTEMS”的美国专利申请序列号12/894,351(现为美国专利公布2012/0080502);
名称为“IMPLANTABLE FASTENER CARTRIDGE HAVING A NON-UNIFORM ARRANGEMENT”的美国专利申请序列号12/894,338(现为美国专利公布2012/0080481);
名称为“IMPLANTABLE FASTENER CARTRIDGE COMPRISING ASUPPORT RETAINER”的美国专利申请序列号12/894,369(现为美国专利公布2012/0080344);
名称为“IMPLANTABLE FASTENER CARTRIDGE COMPRISINGMULTIPLE LAYERS”的美国专利申请序列号12/894,312(现为美国专利公布2012/0080479);
名称为“SELECTIVELY ORIENTABLE IMPLANTABLE FASTENERCARTRIDGE”的美国专利申请序列号12/894,377(现为美国专利公布2012/0080334);
名称为“SURGICAL STAPLING INSTRUMENT WITH COMPACTARTICULATION CONTROL ARRANGEMENT”的美国专利申请序列号12/894,339(现为美国专利公布2012/0080500);
名称为“SURGICAL STAPLING INSTRUMENT WITH A VARIABLESTAPLE FORMING SYSTEM”的美国专利申请序列号12/894,360(现为美国专利公布2012/0080484);
名称为“SURGICAL STAPLING INSTRUMENT WITHINTERCHANGEABLE STAPLE CARTRIDGE ARRANGEMENTS”的美国专利申请序列号12/894,322(现为美国专利公布2012/0080501);
名称为“SURGICAL STAPLE CARTRIDGES WITH DETACHABLESUPPORT STRUCTURES AND SURGICAL STAPLING INSTRUMENTSWITH SYSTEMS FOR PREVENTING ACTUATION MOTIONS WHEN ACARTRIDGE IS NOT PRESENT”的美国专利申请序列号12/894,350(现为美国专利公布2012/0080478);
名称为“IMPLANTABLE FASTENER CARTRIDGE COMPRISINGBIOABSORBABLE LAYERS”的美国专利申请序列号12/894,383(现为美国专利公布2012/0080345);
名称为“COMPRESSIBLE FASTENER CARTRIDGE”的美国专利申请序列号12/894,389(现为美国专利公布2012/0080335);
名称为“FASTENERS SUPPORTED BY A FASTENER CARTRIDGESUPPORT”的美国专利申请序列号12/894,345(现为美国专利公布2012/0080483);
名称为“COLLAPSIBLE FASTENER CARTRIDGE”的美国专利申请序列号12/894,306(现为美国专利公布2012/0080332);
名称为“FASTENER SYSTEM COMPRISING A PLURALITY OFCONNECTED RETENTION MATRIX ELEMENTS”的美国专利申请序列号12/894,318(现为美国专利公布2012/0080480);
名称为“FASTENER SYSTEM COMPRISING A RETENTION MATRIXAND AN ALIGNMENT MATRIX”的美国专利申请序列号12/894,330(现为美国专利公布2012/0080503);
名称为“FASTENER SYSTEM COMPRISING A RETENTIONMATRIX”的美国专利申请序列号12/894,361(现为美国专利公布2012/0080333);
名称为“FASTENING INSTRUMENT FOR DEPLOYING A FASTENERSYSTEM COMPRISING A RETENTION MATRIX”的美国专利申请序列号12/894,367(现为美国专利公布2012/0080485);
名称为“FASTENER SYSTEM COMPRISING A RETENTION MATRIXAND A COVER”的美国专利申请序列号12/894,388(现为美国专利公布2012/0080487);
名称为“FASTENER SYSTEM COMPRISING A PLURALITY OFFASTENER CARTRIDGES”的美国专利申请序列号12/894,376(现为美国专利公布2012/0080486);
名称为“SURGICAL STAPLER ANVIL COMPRISING A PLURALITYOF FORMING POCKETS”的美国专利申请序列号13/097,865(现为美国专利公布2012/0080488);
名称为“TISSUE THICKNESS COMPENSATOR FOR A SURGICALSTAPLER”的美国专利申请序列号13/097,936(现为美国专利公布2012/0080339);
名称为“STAPLE CARTRIDGE COMPRISING A VARIABLETHICKNESS COMPRESSIBLE PORTION”的美国专利申请序列号13/097,954(现为美国专利公布2012/0080340);
名称为“STAPLE CARTRIDGE COMPRISING STAPLES POSITIONEDWITHIN A COMPRESSIBLE PORTION THEREOF”的美国专利申请序列号13/097,856(现为美国专利公布2012/0080336);
名称为“TISSUE THICKNESS COMPENSATOR COMPRISINGDETACHABLE PORTIONS”的美国专利申请序列号13/097,928(现为美国专利公布2012/0080490);
名称为“TISSUE THICKNESS COMPENSATOR FOR A SURGICALSTAPLER COMPRISING AN ADJUSTABLE ANVIL”的美国专利申请序列号13/097,891(现为美国专利公布2012/0080489);
名称为“STAPLE CARTRIDGE COMPRISING AN ADJUSTABLEDISTAL PORTION”的美国专利申请序列号13/097,948(现为美国专利公布2012/0083836);
名称为“COMPRESSIBLE STAPLE CARTRIDGE ASSEMBLY”的美国专利申请序列号13/097,907(现为美国专利公布2012/0080338);
名称为“TISSUE THICKNESS COMPENSATOR COMPRISINGPORTIONS HAVING DIFFERENT PROPERTIES”的美国专利申请序列号13/097,861(现为美国专利公布2012/0080337);
名称为“STAPLE CARTRIDGE LOADING ASSEMBLY”的美国专利申请序列号13/097,869(现为美国专利公布2012/0160721);
名称为“COMPRESSIBLE STAPLE CARTRIDGE COMPRISINGALIGNMENT MEMBERS”的美国专利申请序列号13/097,917(现为美国专利公布2012/0083834);
名称为“STAPLE CARTRIDGE COMPRISING A RELEASABLEPORTION”的美国专利申请序列号13/097,873(现为美国专利公布2012/0083833);
名称为“STAPLE CARTRIDGE COMPRISING COMPRESSIBLEDISTORTION RESISTANT COMPONENTS”的美国专利申请序列号13/097,938(现为美国专利公布2012/0080491);
名称为“STAPLE CARTRIDGE COMPRISING A TISSUE THICKNESSCOMPENSATOR”的美国专利申请序列号13/097,924(现为美国专利公布2012/0083835);
名称为“SURGICAL STAPLER WITH FLOATING ANVIL”的美国专利申请序列号13/242,029(现为美国专利公布2012/0080493);
名称为“CURVED END EFFECTOR FOR A STAPLINGINSTRUMENT”的美国专利申请序列号13/242,066(现为美国专利公布2012/0080498);
名称为“STAPLE CARTRIDGE INCLUDING COLLAPSIBLE DECK”的美国专利申请序列号13/242,086;
名称为“STAPLE CARTRIDGE INCLUDING COLLAPSIBLE DECKARRANGEMENT”的美国专利申请序列号13/241,912;
名称为“SURGICAL STAPLER WITH STATIONARY STAPLEDRIVERS”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”的美国专利申请序列号13/241,637(现为美国专利公布2012/0074201);
名称为“SURGICAL INSTRUMENT WITH SELECTIVELYARTICULATABLE END EFFECTOR”的美国专利申请序列号13/241,629(现为美国专利公布2012/0074200);
名称为“TISSUE THICKNESS COMPENSATOR COMPRISING APLURALITY OF CAPSULES”的美国专利申请序列号13/433,096(现为美国专利公布2012/0241496);
名称为“TISSUE THICKNESS COMPENSATOR COMPRISING APLURALITY OF LAYERS”的美国专利申请序列号13/433,103(现为美国专利公布2012/0241498);
名称为“EXPANDABLE TISSUE THICKNESS COMPENSATOR”的美国专利申请序列号13/433,098(现为美国专利公布2012/0241491);
名称为“TISSUE THICKNESS COMPENSATOR COMPRISING ARESERVOIR”的美国专利申请序列号13/433,102(现为美国专利公布2012/0241497);
名称为“RETAINER ASSEMBLY INCLUDING A TISSUE THICKNESSCOMPENSATOR”的美国专利申请序列号13/433,114(现为美国专利公布2012/0241499);
名称为“TISSUE THICKNESS COMPENSATOR COMPRISING ATLEAST ONE MEDICAMENT”的美国专利申请序列号12/433,136(现为美国专利公布2012/0241492);
名称为“TISSUE THICKNESS COMPENSATOR COMPRISINGCONTROLLED RELEASE AND EXPANSION”的美国专利申请序列号13/433,141(现为美国专利公布2012/0241493);
名称为“TISSUE THICKNESS COMPENSATOR COMPRISING FIBERSTO PRODUCE A RESILIENT LOAD”的美国专利申请序列号13/433,144(现为美国专利公布2012/0241500);
名称为“TISSUE THICKNESS COMPENSATOR COMPRISINGSTRUCTURE TO PRODUCE A RESILIENT LOAD”的美国专利申请序列号13/433,148(现为美国专利公布2012/0241501);
名称为“TISSUE THICKNESS COMPENSATOR COMPRISINGRESILIENT MEMBERS”的美国专利申请序列号13/433,155(现为美国专利公布2012/0241502);
名称为“METHODS FOR FORMING TISSUE THICKNESSCOMPENSATOR ARRANGEMENTS FOR SURGICAL STAPLERS”的美国专利申请序列号13/433,163(现为美国专利公布2012/0248169);
名称为“TISSUE THICKNESS COMPENSATORS”的美国专利申请序列号13/433,167(现为美国专利公布2012/0241503);
名称为“LAYERED TISSUE THICKNESS COMPENSATOR”的美国专利申请序列号13/433,175(现为美国专利公布2012/0253298);
名称为“TISSUE THICKNESS COMPENSATORS FOR CIRCULARSURGICAL STAPLERS”的美国专利申请序列号13/433,179(现为美国专利公布2012/0241505);
名称为“TISSUE THICKNESS COMPENSATOR COMPRISINGCAPSULES DEFINING A LOW PRESSURE ENVIRONMENT”的美国专利申请序列号13/433,115;
名称为“TISSUE THICKNESS COMPENSATOR COMPRISED OF APLURALITY OF MATERIALS”的美国专利申请序列号13/433,118;
名称为“MOVABLE MEMBER FOR USE WITH A TISSUETHICKNESS COMPENSATOR”的美国专利申请序列号13/433,135;
名称为“TISSUE THICKNESS COMPENSATOR AND METHOD FORMAKING THE SAME”的美国专利申请序列号13/433,140;
名称为“TISSUE THICKNESS COMPENSATOR COMPRISINGCHANNELS”的美国专利申请序列号13/433,147;
名称为“TISSUE THICKNESS COMPENSATOR COMPRISING TISSUEINGROWTH FEATURES”的美国专利申请序列号13/433,126;
名称为“DEVICES AND METHODS FOR ATTACHING TISSUETHICKNESS COMPENSATING MATERIALS TO SURGICAL STAPLINGINSTRUMENTS”的美国专利申请序列号13/433,132;以及
名称为“TISSUE THICKNESS COMPENSATOR COMPRISING APLURALITY OF MEDICAMENTS”的美国专利申请序列号13/433,129。
本申请的申请人还拥有以下美国专利申请,这些专利申请的每个都各自全文以引用的方式并入本文:
名称为“STAPLE CARTRIDGES FOR FORMING STAPLES HAVINGDIFFERING FORMED STAPLE HEIGHTS”的美国专利申请序列号11/216,562(现为美国专利7,669,746);
名称为“SURGICAL STAPLING DEVICE WITH ANVIL HAVINGSTAPLE FORMING POCKETS OF VARYING DEPTHS”的美国专利申请序列号11/714,049(现为美国专利公布2007/0194082);
名称为“SURGICAL STAPLING DEVICES THAT PRODUCE FORMEDSTAPLES HAVING DIFFERENT LENGTHS”的美国专利申请序列号11/711,979(现为美国专利8,317,070);
名称为“SURGICAL STAPLING DEVICE WITH STAPLE DRIVERS OFDIFFERENT HEIGHT”的美国专利申请序列号11/711,975(现为美国专利公布2007/0194079);
名称为“SURGICAL STAPLING DEVICE WITH STAPLE DRIVERTHAT SUPPORTS MULTIPLE WIRE DIAMETER STAPLES”的美国专利申请序列号11/711,977(现为美国专利7,673,781);
名称为“SURGICAL STAPLING DEVICE WITH MULTIPLE STACKEDACTUATOR WEDGE CAMS FOR DRIVING STAPLE DRIVERS”的美国专利申请序列号11/712,315(现为美国专利7,500,979);
名称为“STAPLE CARTRIDGES FOR FORMING STAPLES HAVINGDIFFERING FORMED STAPLE HEIGHTS”的美国专利申请序列号12/038,939(现为美国专利7,934,630);
名称为“SURGICAL STAPLING SYSTEMS THAT PRODUCEFORMED STAPLES HAVING DIFFERENT LENGTHS”的美国专利申请序列号13/020,263(现为美国专利公布2011/0147434);
名称为“ROBOTICALLY-CONTROLLED SURGICAL STAPLINGDEVICES THAT PRODUCE FORMED STAPLES HAVING DIFFERENTLENGTHS”的美国专利申请序列号13/118,278(现为美国专利公布2011/0290851);
名称为“ROBOTICALLY-CONTROLLED CABLE-BASED SURGICALEND EFFECTORS”的美国专利申请序列号13/369,629(现为美国专利公布2012/0138660);
名称为“SURGICAL STAPLING DEVICES FOR FORMING STAPLESWITH DIFFERENT FORMED HEIGHTS”的美国专利申请序列号12/695,359(现为美国专利公布2010/0127042);以及
名称为“STAPLE CARTRIDGES FOR FORMING STAPLES HAVINGDIFFERING FORMED STAPLE HEIGHTS”的美国专利申请序列号13/072,923(现为美国专利公布2011/0174863)。
本申请的申请人还拥有以下美国专利申请,这些专利申请与本申请于同一天提交,并且每个都各自全文以引用的方式并入本文:
名称为“SURGICAL STAPLING CARTRIDGE WITH LAYERRETENTION FEATURES”(代理人案卷号END7104USCIP1/110606CIP1)的美国专利申请序列号_______________;
名称为“ADHESIVE FILM LAMINATE”(代理人案卷号END6843USCIP19/100528CP19)的美国专利申请序列号_______________;
名称为“ACTUATOR FOR RELEASING A TISSUE THICKNESSCOMPENSATOR FROM A FASTENER CARTRIDGE”(代理人案卷号END6848USCIP2/100533CIP2)的美国专利申请序列号_______________;
名称为“RELEASABLE TISSUE THICKNESS COMPENSATOR ANDFASTENER CARTRIDGE HAVING THE SAME,”(代理人案卷号END6848USCIP3/100533CIP3)的美国专利申请序列号_______________;
名称为“FASTENER CARTRIDGE COMPRISING A RELEASABLETISSUE THICKNESS COMPENSATOR”(代理人案卷号END6848USCIP4/100533CIP4)的美国专利申请序列号_______________;
名称为“FASTENER CARTRIDGE COMPRISING A CUTTINGMEMBER FOR RELEASING A TISSUE THICKNESS COMPENSATOR”(代理人案卷号END6848USCIP5/100533CIP5)的美国专利申请序列号_______________;
名称为“FASTENER CARTRIDGE COMPRISING A RELEASABLYATTACHED TISSUE THICKNESS COMPENSATOR”(代理人案卷号END6848USCIP6/100533CIP6)的美国专利申请序列号_______________;
名称为“STAPLE CARTRIDGE COMPRISING A RELEASABLECOVER”(代理人案卷号END7201USNP/120294)的美国专利申请序列号_______________;
名称为“ANVIL LAYER ATTACHED TO A PROXIMAL END OF ANEND EFFECTOR”(代理人案卷号END7102USCIP2/110604CIP2)的美国专利申请序列号_______________;
名称为“LAYER COMPRISING DEPLOYABLE ATTACHMENTMEMBERS”(代理人案卷号END7102USCIP3/110604CIP3)的美国专利申请序列号_______________;
名称为“END EFFECTOR COMPRISING A DISTAL TISSUEABUTMENT MEMBER”(代理人案卷号END7102USCIP4/110604CIP4)的美国专利申请序列号_______________;
名称为“LAYER ARRANGEMENTS FOR SURGICAL STAPLECARTRIDGES”(代理人案卷号END6232USCIP1/070348CIP1)的美国专利申请序列号_______________;
名称为“IMPLANTABLE ARRANGEMENTS FOR SURGICAL STAPLECARTRIDGES”(代理人案卷号END6232USCIP2/070348CIP2)的美国专利申请序列号_______________;
名称为“MULTIPLE THICKNESS IMPLANTABLE LAYERS FORSURGICAL STAPLING DEVICES”(代理人案卷号END6840USCIP2/100525CIP2)的美国专利申请序列号_______________;
名称为“ACTUATOR FOR RELEASING A LAYER OF MATERIALFROM A SURGICAL END EFFECTOR”(代理人案卷号END6232USCIP4/070348CIP4)的美国专利申请序列号_______________;以及
名称为“STAPLE CARTRIDGE COMPRISING A COMPRESSIBLEPORTION”(代理人案卷号END7200USNP/120302)的美国专利申请序列号_______________。
现将描述某些示例性实施例,以从整体上来理解本文所公开的装置和方法的结构、功能、制造和用途的原理。这些实施例的一个或多个实例在附图中示出。本领域的普通技术人员将会理解,在本文中具体描述并示出于附图中的装置和方法为非限制性示例性实施例,并且本发明的多个实施例的范围仅由权利要求书限定。结合一个示例性实施例进行图解说明或描述的特征可与其他实施例的特征进行组合。此类修改和变型旨在包括在本发明的范围之内。
本说明书通篇提及的“各种实施例”、“一些实施例”、“一个实施例”或“实施例”等意味着结合所述实施例描述的具体特征、结构或特性包括在至少一个实施例中。因此,本说明书通篇出现的短语“在各种实施例中”、“在一些实施例中”、“在一个实施例中”或“在实施例中”等并不一定都指相同的实施例。此外,在一个或多个实施例中,具体特征、结构或特性可以任何合适的方式结合。因此,在无限制的情形下,结合一个实施例示出或描述的具体特征、结构或特性可全部或部分地与一个或多个其他实施例的特征、结构或特性结合。此类修改和变型旨在包括在本发明的范围之内。
本文所用术语“近侧”和“远侧”是相对于操纵外科器械的柄部的临床医生而言的。术语“近侧”是指最靠近临床医生的部分,并且术语“远侧”则是指远离临床医生的部分。还应当理解,为方便和清楚起见,本文可以结合附图使用诸如“垂直”、“水平”、“上”和“下”之类的空间术语。然而,外科器械能够在许多取向和位置使用,并且这些术语并非限制性和/或绝对的。
提供各种示例性装置和方法以执行腹腔镜式和微创外科手术操作。然而,本领域的普通技术人员将容易理解,本文所公开的各种方法和装置可用于许多外科手术和应用中,包括例如与开放式外科手术相结合。继续参阅本具体实施方式,本领域中的普通技术人员将进一步理解,本文所公开的各种器械可以任何方式插入体内,诸如通过自然腔道、通过形成于组织中的切口或穿刺孔等。器械的工作部分或端部执行器部分可被直接插入于患者体内或可通过具有工作通道的进入装置来插入,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。
在各种实施例中,外科缝合器械诸如器械10,例如可包括柄部、从柄部延伸的轴、以及从轴延伸的被构造成能够处理患者的组织的端部执行器。参见图1,器械10的柄部组件12可附接到器械轴16的第一或近侧端部13,此外,端部执行器组件14被构造成能够附接到器械轴16的第二或远侧端部15。在各种实施例中,在微创外科手术过程中,端部执行器组件14和器械轴16的至少一部分被构造成能够定位在插管或套管针内,并且至少部分地通过其插入患者体内。多种外科器械在以下美国专利申请中更详细地描述:提交于2006年1月10日的名称为“SURGICAL INSTRUMENTHAVING AN ARTICULATING END EFFECTOR”的美国专利申请序列号11/329,020,提交于2006年1月31日的名称为“SURGICAL CUTTINGAND FASTENING INSTRUMENT WITH CLOSURE TRIGGER LOCKINGMECHANISM”的美国专利申请序列号11/343,321,以及提交于2006年9月29日的名称为“SURGICAL STAPLES HAVING ATTACHED DRIVERSAND STAPLING INSTRUMENTS FOR DEPLOYING THE SAME”的美国专利申请序列号11/529,935,所述专利的全部公开内容据此以引用方式并入本文。
在各种实施例中,进一步地,端部执行器组件14可包括第一钳口构件20和第二钳口构件424,其中第一钳口构件和第二钳口构件中的至少一个被构造成能够相对于另一个钳口构件运动,使得患者的组织可被夹紧在两者间。参见图1至图3和图5,第一钳口构件20可包括钉仓422,此外,第二钳口构件424可包括砧座426。在至少一个实施例中,钉仓422可包括平台,其具有限定于其中的多个钉腔。砧座426可包括砧座盖427和砧座面,其中所述砧座面可具有限定于其中的多个砧座凹坑。在各种实施例中,每个钉腔被构造成能够将钉可移除地储存在其中,并且每个砧座凹坑被构造成能够在钉被部署时使钉的至少一部分变形。在各种实施例中,钉仓和砧座中的至少一个可包括一个或多个夹持特征结构或脊435,其被构造成能够将组织保持在端部执行器内。
进一步地,端部执行器组件14可包括至少一片支撑材料436和/或436’,其被构造成能够定位在第一钳口构件和第二钳口构件中间并且能够可释放地保持到例如仓平台和/或砧座面之一上。在至少一个实施例中,支撑材料片上的表面被构造成能够在组织被夹紧在第一钳口构件和第二钳口构件之间时接触组织。在此类实施例中,支撑材料表面可用于将压缩夹紧力分配在组织上方、从组织移除多余的流体、以及/或者改善钉的紧抓。在各种实施例中,可将一片或多片支撑材料定位在端部执行器组件内。在至少一个实施例中,可将一片支撑材料436附接到钉仓422,并且可将一片支撑材料436’附接到砧座426。在至少一个其他实施例中,例如可将两片支撑材料436定位在仓平台上,并且可将一片支撑材料436’定位在砧座面上。在其他多种实施例中,任何合适数目的支撑材料片可定位在端部执行器组件内。在任何情况下,在各种实施例中,支撑材料片可由以下材料构成,诸如可生物吸收的材料、可生物分解的材料和/或可溶解的材料,例如使得支撑材料在愈合过程期间可被吸收、分解和/或溶解。在至少一个实施例中,支撑材料片可至少部分地由治疗药物构成,所述治疗药物例如被构造成能够随时间推移而释放以有助于组织愈合。在另外的各种实施例中,支撑材料片可包括例如不可吸收和/或不可溶解的材料。
在各种实施例中,端部执行器组件可包括至少一个连接构件或紧固件,诸如连接构件38,例如其可用于将支撑材料片可释放地保持到例如砧座和钉仓中的至少一者。在各种实施例中,连接构件被构造成能够从端部执行器释放并且沿着支撑材料片部署。在至少一个实施例中,连接构件的头部部分被构造成能够与连接构件的主体部分分离,使得头部部分可部署有支撑材料片,而主体部分保持附接到端部执行器。在其他多种实施例中,当支撑材料片从端部执行器脱离时,连接构件的整体可保持与端部执行器接合。在任何情况下,在至少一个实施例中,连接构件可至少部分地由可生物吸收的材料、可生物分解的材料和可溶解的材料中的至少一种构成,使连接构件可被吸收、分解和/或溶解在体内。在各种实施例中,连接构件由治疗药物构成,所述治疗药物例如被构造成能够随时间推移而释放以有助于组织愈合。在另外的各种实施例中,连接构件可包括例如不可吸收和/或不可溶解的材料,诸如塑料。
在各种实施例中,连接构件可以任何合适的模式或构型来布置。在至少一个实施例中,连接构件可例如围绕支撑材料片436的外周边定位。在至少一个实施例中,连接构件可定位在支撑材料片的一个或多个侧面和/或端部的近侧,例如以在端部执行器通过套管针插入或与组织接合时防止或至少有助于防止支撑材料从钉仓平台和/或砧座面剥离。在各种实施例中,连接构件可与任何合适的粘合剂诸如氰基丙烯酸酯结合使用,例如以将支撑材料片或支撑材料的至少一部分可释放地保持到端部执行器。在至少一个实施例中,可在连接构件与支撑材料片、钉仓和/或砧座中的孔接合之前将粘合剂施加到连接构件。
参见图4,保持构件被构造成能够在端部执行器内在第一位置与第二位置之间运动以将组织厚度补偿件可释放地保持到端部执行器。端部执行器组件214可包括具有钉仓222的第一钳口和具有砧座226的第二钳口,其中保持构件262可相对于钉仓222和砧座226运动。例如,保持构件262可在远侧端部264附近的第一或延伸位置至近侧端部263附近的第二或回缩位置之间运动。在其延伸位置中,保持构件262可在端部执行器214被插入到手术部位中时将组织厚度补偿件诸如组织厚度补偿件236保持在适当位置。其后,端部执行器214可闭合到例如组织上,并且钉可通过补偿件236部署到组织中。保持构件262可运动到其回缩位置中,使得保持构件262能够可操作地脱离补偿件236。另选地,保持构件262可在钉被部署之前回缩。在任何情况下,鉴于上文所述,端部执行器214可被打开并且从手术部位撤回,留下缝合的补偿件236和组织。
在各种实施例中,参见图6和图7,至少一个弹性构件可用于将支撑材料片可释放地保持到端部执行器的钉仓和/或砧座。与上文相似,端部执行器的第一钳口520可包括钉仓522,并且第二钳口524可包括砧座526。在至少一个实施例中,至少一个弹性构件诸如弹性构件550或550’例如可包括第一端部诸如第一端部552或552’,该第一端部被构造成能够附接到第一钳口构件520和第二钳口构件524中的至少一者,或者与其整体地形成。在至少一个实施例中,每个弹性构件550可包括第二端部诸如第二端部554或554’,该第二端部例如被构造成能够接触支撑材料片诸如支撑材料片536并且将其可释放地保持到例如第一钳口构件和第二钳口构件中的至少一者。在各种实施例中,第二端部554可包括顶端558,其被构造成能够夹持例如支撑材料片536的至少一部分。在各种实施例中,顶端558可被成形和/或被构造成能够包括粗糙或有棱纹的表面,例如以便摩擦接合支撑材料片。相似地,每个第二端部554’可包括顶端558’,其被构造成能够将支撑材料片接合并保持到砧座。
在各种实施例中,再次参见图6和图7,多个弹性构件可被设置在钳口构件的至少两侧上以将支撑材料片的侧面部分保持到钳口构件。在至少一个实施例中,每个独立弹性构件550的第一端部552可通过例如连接构件诸如连接构件或棒556或556’来附接到彼此。在各种实施例中,连接构件556可附接到第二钳口构件524,使得连接构件556可向弹性构件550提供支撑。在其他各种实施例中,可在不使用连接构件的情况下将多个弹性构件550附接到第一钳口构件和第二钳口构件中的至少一者。在此类实施例中,弹性构件的第一端部可直接附接到例如第一钳口构件和第二钳口构件中的一者。在至少一个实施例中,弹性构件550例如被构造成能够在钉已通过支撑材料部署之后以及/或者在支撑材料脱离端部执行器时释放支撑材料536。在至少一个实施例中,弹性构件可由例如弹性材料诸如金属或塑料构成。
如上文所概述,端部执行器组件可包括钉仓、砧座、以及定位在钉仓与砧座中间的至少一片支撑材料。在至少一个实施例中,参见图8,一片支撑材料诸如支撑材料336被构造成能够按扣配合到钉仓322和/或砧座中的至少一者,以使该支撑材料片可释放地保持在端部执行器内。钉仓322可包括第一侧壁302和与第一侧壁302相背对的第二侧壁,其中第一侧壁和第二侧壁中的至少一者可包括从其向外延伸的唇缘306。在各种实施例中,支撑材料336可包括第一边缘或侧308、第二边缘或侧310和至少部分沿边缘308和310的长度延伸的至少一个唇缘312。在至少一个实施例中,唇缘312被构造成能够以按扣配合的方式接合唇缘306,以便将支撑材料336可释放地保持到钉仓322。
进一步地,支撑材料336可包括表面316,该表面被构造成能够与钉仓322的平台328相邻定位,或抵靠其定位。在至少一个实施例中,侧边缘308和310可包括侧壁,该侧壁可相对于表面316在垂直或横向方向上延伸。在此类实施例中,唇缘312可从这些侧壁延伸,使得唇缘312可被联锁在钉仓322的唇缘306后。在各种实施例中,当从钉仓322部署钉时,支撑材料336的唇缘312可脱离钉仓322的唇缘306。更具体地讲,当部署钉时,钉可接触支撑材料336,向支撑材料336施加向上力,并且将支撑材料336从钉仓322分离。因此,有利的是,当如上所述从钉仓322部署钉时和/或当打开端部执行器时,支撑材料336可自动地脱离钉仓322。
在各种实施例中,支撑材料片可包括从其延伸的至少一个构件,该构件被构造成能够将支撑材料可释放地保持到钉仓和/或砧座之一。在至少一个实施例中,一个或多个构件318可从支撑材料336沿着垂直于或横向于表面316的方向延伸。在各种实施例中,每个构件318可以摩擦配合或压力配合方式与限定在平台328中的钉腔320接合,以将该支撑材料片336可释放地保持到钉仓。在某些实施例中,支撑材料片可包括接合砧座中的凹坑的构件。类似于上文所述,在各种实施例中,从钉腔320部署的钉可向支撑材料336施加向上力,并且使构件318脱离钉腔320。在各种实施例中,钉可刺穿突出部318和/或支撑材料336,以将该支撑材料固定到组织,如上文所概述。
如图8所示,支撑材料片可包括从其延伸的多于一个构件或突出部来将支撑材料片保持到钉仓和砧座之一。在各种实施例中,参见图9和图10,多于一个构件318’可例如从支撑材料片336’延伸。在至少一个实施例中,构件318’可压力配合到钉仓322’的钉腔320’中和/或砧座(未示出)的砧座凹坑中,使得构件可将该支撑材料片摩擦地保持到钉仓和/或砧座,如上文所概述。在各种实施例中,除了限定在钉仓中被构造成能够摩擦地接收构件318’的钉腔之外,钉仓可在其中包括狭槽或孔。同样,在各种实施例中,除了限定在其中被构造成能够摩擦地接收构件318’的钉成形凹坑之外,砧座可在其中包括狭槽或孔。
图11和图28示出了外科缝合器械的一个实施例。简而言之,外科缝合器械包括柄部组件12和细长轴14。一次性加载单元或DLU16可释放地固定到轴14的远侧端部。一次性加载单元16包括工具组件17,该工具组件具有仓组件18外壳、多个外科钉、以及相对于仓组件18可运动地固定的砧座组件20。一次性加载单元16被构造成能够施加长度测量为约30mm至约60mm的线性钉排。还设想到具有其他长度例如,45mm的线性钉排的一次性加载单元。柄部组件12包括固定的柄部构件22、可动柄部构件24、以及筒形部分26。可旋转构件28被安装在筒形部分26的前端上,以有利于细长主体14相对于柄部组件12的旋转。关节运动杠杆30也安装在筒形部分26的前端上邻近可旋转旋钮28,以有利于工具组件17的关节运动。一对回缩旋钮32沿着筒形部分26可运动地定位,以使外科缝合装置10返回到回缩位置,如下文将详述。
柄部组件12包括由模制外壳半部分36a和36b形成的外壳,其形成柄部组件12的固定柄部构件22和筒形部分26(参见图1)。可动柄部构件24围绕枢轴销38被可枢转地支撑在外壳半部分36a和36b之间。作为扭转弹簧的偏置构件40使可动柄部24偏置远离固定柄部22。致动轴46被支撑在外壳36的筒形部分26内并且包括带齿齿条48。具有带有侧向延伸翼43a和43b的齿条接合指状物43的驱动棘爪42围绕枢轴销44可枢转地安装到可动柄部24的一个端部。同样作为扭转弹簧的偏置构件50被定位成迫使驱动棘爪42的接合指状物43朝向致动轴46的带齿齿条48。可动柄部24能够枢转以使驱动棘爪42的接合指状物43运动成与致动轴46的带齿齿条48接触,以将致动轴沿远侧方向线性地推进。致动轴46的前端可旋转地接收控制杆52的近侧端部49,使得致动轴46的线性推进导致控制杆52的相应线性推进。具有齿条接合构件55的锁定棘爪54围绕枢轴销57可枢转地安装在外壳36内,并且通过偏置构件56朝向带齿齿条48偏置,该偏置构件同样为扭转弹簧。锁定棘爪54的接合构件55可运动成与带齿齿条48接合,以将致动轴46保持在纵向固定位置。
包括一对牵开器旋钮32的回缩机构58通过联接杆60连接到致动轴46的近侧端部。联接杆60包括用于接收牵开器旋钮32的右接合部分62a和左接合部分62b、以及中心部分62c,该中心部分的尺寸设定成并被构造成能够在形成于邻近其近侧端部的致动轴46中的一对纵向狭槽34a内平移。释放板64与致动轴46操作地相联,并且被安装用于响应于牵开器旋钮32的操纵而相对于其运动。一对间隔开的销66从致动轴46的侧面向外延伸,以接合形成于释放板64中的一对对应的成角度凸轮狭槽68。在牵开器旋钮32向后运动时,销66可相对于致动轴46并且相对于带齿齿条48向下释放板64,使得释放板64的底部部分在带齿齿条48下面延伸以使驱动棘爪42的接合指状物43从带齿齿条48。横向狭槽70在释放板64的近侧端部处形成,以容纳联接杆60的中心部分62c,并且细长狭槽34(参见图1)被限定在柄部组件12的筒形部分26中,以在回缩旋钮32被向后牵拉来使致动轴46回缩,从而使控制杆52向后回缩时适应联接杆60的纵向平移。致动轴46通过弹簧72朝近侧偏置,该弹簧在一个端部处通过连接器74被固定到联接杆部分62,并且在另一个端部处被固定到致动轴46上的柱76。
进一步地,柄部组件12包括击发闭锁组件80,该击发闭锁组件包括柱塞82和可枢转锁定构件83。柱塞82通过偏置弹簧84而被偏置到中心位置并且包括环形渐缩凸轮表面85。柱塞82的每个端部穿过邻近固定柄部22的上端的外壳36延伸。可枢转锁定构件83围绕枢轴销86在外壳半部分36a和36b之间可枢转地附接在其远侧端部处,并且包括锁定表面88和具有形成于其中的狭槽89的近侧延伸部90。锁定构件83通过弹簧92被逆时针偏置(如图11所示),以使锁定表面88运动成邻接致动轴46的远侧端部,从而防止轴46的推进和缝合装置的随后击发。环形渐缩凸轮表面85被定位成延伸到近侧延伸部90中的渐缩狭槽89中。柱塞82抵抗任一弹簧84的偏置而沿任一方向的侧向运动使渐缩凸轮表面85运动成与渐缩狭槽89的侧壁接合,从而围绕枢轴销86顺时针枢转锁定构件83,如图11所示,以使阻挡表面88运动到一位置以允许致动轴46的推进,从而允许缝合装置10的击发。阻挡表面88通过凹槽保持在该位置中,该凹槽接收凸轮表面85的渐缩顶端以将锁定构件83锁定在逆时针位置中。击发闭锁组件80的操作将在下文中进一步说明。
进一步地,柄部机构12还包括抗逆转离合器机构,该抗逆转离合器机构包括可旋转地安装在第一轴96上的第一齿轮94和安装在第二轴100上的第二齿轮98、以及可滑动地安装在外壳36内的滑动板(未示出)。滑动板包括尺寸设定成并且被构造成能够围绕锁定棘爪枢轴销57可滑动地定位的细长狭槽、被构造成能够与第二齿轮98的齿啮合的齿轮板、以及凸轮表面。在回缩位置中,滑动板的凸轮表面接合锁定棘爪54,以防止锁定棘爪54接合带齿齿条48。致动轴46包括与近侧组齿轮齿间隔的远侧组齿轮齿,所述近侧组齿轮齿被定位成在致动轴46运动的过程中接合致动轴46的第一齿轮94。当通过围绕枢轴销38枢转可动柄部24来推进致动轴46时,致动轴46上的远侧齿轮齿与第一齿轮94和第一轴96啮合并使其旋转。第一轴96通过弹簧离合器组件连接到第二轴100,使得第一轴96的旋转将导致第二轴100的对应旋转。第二轴100的旋转导致第二齿轮98的对应旋转,该第二齿轮与滑动板上的齿轮板接合以导致滑动板的线性推进。滑动板的线性推进受细长狭槽的长度的限制。当滑动板已被推进狭槽的长度时,凸轮表面释放锁定棘爪54,使得其运动成与带齿齿条48接合。致动轴46的继续推进最终使远侧齿轮齿运动成与齿轮板接合。然而,由于滑动板纵向被固定在合适的位置,弹簧离合器被迫释放,使得致动轴46得以继续远侧推进。
当致动轴46(通过朝近侧牵拉回缩旋钮34,如上所述)返回到回缩位置时,远侧齿轮齿接合第一齿轮94以使第二齿轮98沿反向方向旋转,以使滑动构件在外壳36内朝近侧回缩。滑动构件的近侧运动将凸轮表面推进到锁定棘爪54中,然后在锁定棘爪54与带齿齿条48之间接合,从而将锁定棘爪54推动到一位置以允许致动轴46回缩。
再次参见图11,柄部组件12包括围绕被支撑在外壳半部分36a和36b之间的枢转构件114可枢转地安装在外壳36内的应急返回按钮112。返回按钮112包括定位在筒形部分26的近侧端部上的在外部定位的构件116。构件116能够围绕枢转构件114运动成与锁定棘爪54的近侧端部接合,以推动齿条接合构件55脱离与带齿齿条48的接合,从而允许致动轴46在缝合装置10的击发行程期间回缩。
如上所述,在致动轴46的夹持部分的推进过程中,滑动板使棘爪54脱离齿条48,因此不需要返回按钮112的致动来使致动轴46回缩。图12至图14示出细长主体14和柄部组件12的互连。外壳36包括被构造成能够接收形成于旋转构件28的近侧端部上的环形肋118的环形通道117,旋转构件28由模制半部分28a和28b形成。环形通道117和肋118允许旋转构件28与外壳36之间的相对旋转。细长主体14包括内部外壳122和外部壳体124。内部外壳122的尺寸设定成被接收在外部壳体124内,并且包括内部镗孔126,该内部镗孔延伸穿过内部外壳并且其尺寸设定成可滑动地接收第一关节运动联接件123和控制杆52。外壳122和壳体124的近侧端部各自分别包括一对沿直径相对的开口130和开口128,所述开口的尺寸设定成接收形成于旋转构件28的远侧端部上的径向突出部132。突出部132以及开口128和开口130固定地将旋转构件28和细长主体14相对于彼此纵向且可旋转地固定。旋钮28相对于柄部组件12的旋转从而导致细长主体14相对于柄部组件12的对应旋转。
关节运动机构120被支撑在可旋转构件28上,并且包括关节运动杠杆30、凸轮构件136、平移构件138和第一关节运动联接件123。关节运动杠杆30围绕枢转构件140可枢转地安装,该枢转构件从旋转构件28向外延伸并且与其整体地形成。突出部142从关节运动杠杆30向下延伸以与凸轮构件136接合。平移构件138的远侧端部包括臂160,该臂包括被构造成能够接收从关节运动联接件123的近侧端部延伸的指状物164的开口162。具有由非研磨材料例如特氟隆构成的外壳168的销166被固定到平移构件138,并且其尺寸设定成被接收在阶梯式凸轮表面内。在组装的条件下,凸轮构件136的近侧阶梯部分150和远侧阶梯部分152被定位在凸缘诸如凸缘170下,该凸缘形成于旋转构件28上以限制凸轮构件136相对于缝合装置10的纵向轴线横向运动。当关节运动杠杆30围绕枢转构件140枢转时,凸轮构件136在旋转构件28上横向运动,以使阶梯式凸轮表面148相对于销166横向运动,从而迫使销166沿着阶梯式凸轮表面148朝近侧或朝远侧运动。由于销166固定地附接到平移构件138,平移构件138朝近侧或朝远侧运动以实现第一致动联接件123的相应近侧或远侧运动。
一次性加载单元感测机构在缝合器械内从细长主体14延伸到柄部组件12中。感测机构包括传感器管176,该传感器管被可滑动地支撑在细长主体14的镗孔26内。传感器管176的远侧端部朝向细长主体14的远侧端部定位,并且传感器管176的近侧端部经由一对接合块180固定在传感器圆筒178的远侧端部内。传感器联接件182的远侧端部被固定到传感器圆筒178的近侧端部。传感器联接件182具有球状端部184,该球状端部将凸轮表面接合在可枢转锁定构件83上。当一次性加载单元插入细长主体14的远侧端部中时,一次性加载单元接合传感器管176的远侧端部以朝近侧驱动传感器管176,从而朝近侧驱动传感器圆筒178和传感器联接件182。传感器联接件182朝近侧的运动导致传感器联接件182的球状端部184朝凸轮表面的远侧运动,以允许锁定构件83在弹簧92从允许缝合装置10的击发的位置偏置到阻挡位置的情况下枢转,其中阻挡构件83被定位成接合致动轴46并且防止缝合装置10的击发。传感器联接件182和锁定构件83用于防止外科缝合装置10在一次性加载单元已被固定到细长主体14之后击发,无需第一操作击发闭锁组件80。
进一步地,凸轮构件136可包括限定在其底部部分中的凹槽。具有被构造成能够被接收在该凹槽内的接合块部分186的锁定环184可围绕传感器圆筒178定位在控制接片部分188与近侧凸缘部分190之间。定位在凸缘部分190与锁定环184之间的弹簧192围绕传感器圆筒178朝远侧推动锁定环。当具有延伸插入顶端193的关节运动一次性加载单元(图16)被插入缝合装置10的细长主体14的远侧端部中时,插入顶端193致使接片部分188朝近侧运动成与锁定环184接合,以朝凸轮构件136中的凹槽154的近侧推动锁定环184和接合块186。利用定位在凸轮构件136中的凹槽的近侧的接合块186,凸轮构件136自由地横向运动以实现缝合装置10的关节运动。非关节运动一次性加载单元可不具有延伸插入顶端。因此,当非关节运动一次性加载单元被插入细长主体14中时,传感器圆筒178不朝近侧回缩足以使接合块186从凹槽154运动的距离。因此,通过锁定环184的接合块186防止凸轮构件136横向运动,该接合块被定位在限定于凸轮构件136中的凹槽中,并且关节运动杠杆30锁定在其中心位置。
参见图15至图18,一次性加载单元,诸如一次性加载单元16a和/或16b,例如包括适于可释放地接合主体部分14的远侧端部的近侧外壳部分200。安装组件202可枢转地固定到外壳部分200的远侧端部,并且被构造成能够接收工具组件17的近侧端部,使得安装组件202围绕垂直于外壳部分200的纵向轴线的轴线的枢转运动使工具组件17围绕枢轴销244进行关节运动。一次性加载单元16的外壳部分200可包括(一)用于可释放地接合细长轴14的接合块254和(二)插入顶端193。接合块254与轴14的远侧端部形成卡口式联接。第二关节运动联接件的尺寸设定成被可滑动地定位在形成于外壳部分200的外壳半部之间的狭槽258内。
参见图19至图27,工具组件17包括砧座组件20和仓组件18。砧座组件20包括砧座部分204,该砧座部分具有多个钉变形凹部206以及固定到砧座部分204的顶部表面以在其间限定腔210的覆盖板208。提供覆盖板208以防止在外科缝合装置夹紧和击发过程中组织紧缩。腔210的尺寸设定成接收轴向驱动组件212的远侧端部。纵向狭槽214延伸穿过砧座部分204以有利于轴向驱动组件212的固定凸缘284进入砧座腔210中。形成于砧座部分204上的凸轮表面209被定位成接合轴向驱动组件212以有利于夹紧组织198。形成于砧座部分204上的一对枢转构件211被定位在形成于载体216中的狭槽213内,以在打开位置和夹紧位置之间引导砧座部分。一对稳定构件可接合形成于载体216上的相应肩部217,以防止砧座部分204在凸轮表面209变形时相对于钉仓220轴向滑动。
仓组件18包括载体216,其限定细长支撑通道218。细长支撑通道218的尺寸设定成并被构造成能够接收钉仓220。沿着钉仓220和细长支撑通道218形成的对应接片222和狭槽224用于将钉仓220保持在支撑通道218内。形成于钉仓220上的一对支撑柱223被定位成静置在载体216的侧壁上,以进一步将钉仓220稳定在支撑通道218内。钉仓220包括用于接收多个紧固件226和推动器228的保持狭槽225。多个间隔开的纵向狭槽230延伸穿过钉仓220以容纳致动滑动件234的直立凸轮楔形件232。中心纵向狭槽282沿着钉仓220的长度延伸以有利于刀片280通过。在外科缝合器操作过程中,致动滑动件234平移穿过钉仓220的纵向狭槽230,以推进凸轮楔形件232与推动器228连续接触,以使推动器228在狭槽225内竖直地平移并且将紧固件226从狭槽225推动到砧座组件20的钉变形腔206中。
进一步地,外科缝合器械的轴可包括上安装部分236和下安装部分238。每个安装部分包括在其每个侧面上的螺纹镗孔240,该螺纹镗孔的尺寸设定成接收螺纹螺栓242,以将载体216的近侧端部固定到其上。一对中心定位的枢转构件244通过一对联接构件在上部安装部分和下部安装部分之间延伸,所述联接构件接合外壳部分200的远侧端部。一次性加载单元的外壳部分200可包括容纳在外部壳体251内的上半部外壳和下半部外壳。第二关节运动联接件256的尺寸设定成被可滑动地定位在形成于外壳半部之间的狭槽内。一对防爆板254邻近与轴向驱动组件212的远侧端部相邻的外壳部分200的远侧端部定位,以防止在工具组件17的关节运动过程中驱动组件212向外凸出。第二关节运动联接件256包括至少一个细长金属板。优选地,堆叠两个或更多个金属板以形成联接件256。关节运动联接件256的近侧端部包括被构造成能够接合第一关节运动联接件123的钩部分258,并且远侧端部包括尺寸设定成接合形成于安装组件202上的突出部262的环260。突出部262与枢轴销244侧向偏置,使得第二关节运动连接件256的线性运动导致安装组件202围绕枢轴销244枢转,从而使工具组件17进行关节运动。
驱动梁266的远侧端部由支撑刀片280和邻接表面283的竖直支撑柱278限定,在缝合手术期间,所述邻接表面接合致动滑动件234的中心部分。在表面283的基部处的表面285被构造成能够接收沿着钉仓220的底部可滑动地定位的支撑构件287。刀片280定位成在致动滑动件234后面略微平移通过钉仓220中的中间纵向狭槽282,以在缝合的身体组织排之间形成切口。固定凸缘从竖直支撑柱向远侧突出,并且在其远侧端部处支撑圆柱形凸轮辊286。凸轮辊286的尺寸设定成并且被构造成能够接合砧座主体204上的凸轮表面209以抵靠身体组织夹紧砧座部分204。
在各种实施例中,现在参见图30和图31,外科缝合器械的端部执行器可包括具有钉仓组件的第一钳口680和第二钳口670。第一钳口680可包括盘680a、可定位在盘680a中的仓体682、以及滑动件690,该滑动件可运动穿过仓体682以朝仓体682的平台682a提升驱动器692并且射出可移除地储存在限定于其中的钉腔中的钉684。仓体682还可包括多个狭槽682b,所述狭槽各自被构造成能够接收滑动件690的凸轮,诸如凸轮690a-690c,例如,所述凸轮被构造成能够接合并提升驱动器692。钉仓组件还可包括层B2,该层可使用连接器S3和S4附接到仓体682。在各种实施例中,每个连接器S3和S4可包括将层B2系到仓体682的缝合线。例如,连接器S3可将层B2的远侧端部安装到仓体682的远侧端部682f,而连接器S4可将层B2的近侧端部安装到仓体682的近侧端部682e。在使用中,切割构件,诸如切割构件660,例如可被推进穿过仓体682并且切入或以其他方式克服连接器S3和S4。例如,切割构件660可包括主体662、被构造成能够分别接合第二钳口670和第一钳口680的凸缘664a和664b、以及被构造成能够横穿限定在仓体682a中的纵向狭槽682c的切割构件66。切割构件660可通过击发构件组件650朝远侧推进穿过仓体682。击发构件组件650可包括由多个层组成的轴652,所述多个层包括接合在切割构件主体662内的远侧端部654以及被构造成能够接收施加到其上的击发力的近侧端部656。
进一步地,当击发力被施加到击发构件650时,凸缘664a可接合第二钳口670并且使第二钳口670朝向第一钳口680向下枢转。第二钳口670可包括砧座组件623,该砧座组件可包括框架672和具有多个限定在其中的砧座凹坑的砧座板。在击发构件650被朝远侧推进时,切割构件660可穿过限定在砧座板中的纵向狭槽670b。类似于上文所述,第二钳口670还可包括例如通过一个或多个连接器诸如连接器S1和S2附接到其上的层B1。同样类似于上文所述,连接器S1和S2可各自包括缝合线,其中连接器S1被构造成能够将层B1的远侧端部可释放地保持到砧座组件623的远侧端部670e,并且其中连接器S2被构造成能够将层B2的远侧端部可释放地保持到砧座组件623的近侧端部670c。在各种实施例中,砧座组件623可包括组装到框架672的远侧前缘676,并且可包括限定在其中的被构造成能够接收连接器S1的狭槽676a。相似地,框架672的近侧端部可包括限定在其中的被构造成能够接收连接器S2的狭槽672a。在任一种情况下,在各种实施例中,连接器S1和S2可围绕整个砧座框架672延伸,而在其他实施例中,连接器S1和S2可接合砧座组件623的侧面。当切割构件660穿过砧座组件623朝远侧推进时,切割构件660可切断或以其他方式克服连接器S1和S2,以从砧座组件623释放层B1。更具体地讲,在各种实施例中,层B1可被定位在患者组织的一侧上,并且层B2可被定位在患者组织的相对侧上,其中当击发构件650朝远侧推进时,钉684可随后击发穿过层B2、患者组织和层B1。在击发构件650朝远侧推进时,切割构件660可在层B1和层B2被切割构件660逐步切断时逐步切断连接器S1-S4。例如,切割构件660可在行程开始时切断连接器S2和S4,并且在行程结束时切断连接器S1和S3。在各种实施例中,现在参见图32和图33,端部执行器716可包括第一钳口718和第二钳口720,其中连接器774可被嵌入限定于第二钳口720的砧座772中的狭槽770e内。
参见图33A,外科缝合器械的端部执行器可包括第一钳口和第二钳口,其中第一钳口和第二钳口中的至少一者被构造成能够相对于另一者运动。例如,端部执行器可包括具有钉仓通道1050的第一钳口和具有砧座的第二钳口,其中砧座可朝向和/或远离钉仓通道1050枢转。在各种另选的实施例中,包括钉仓的第一钳口可朝向和/或远离包括砧座的第二钳口枢转。在任一种情况下,钉仓通道1050被构造成能够接收钉仓1060,例如,其能够可移除地保持在钉仓通道1050内。钉仓1060可包括仓体1062、仓平台1064和组织厚度补偿件1000,其中如图33A所示,组织厚度补偿件1000能够可移除地抵靠或邻近仓平台1064定位。类似于本文所述的其他实施例,现在参见图33A和图34,仓体1062可包括多个钉腔1066和定位在每个钉腔1066内的钉1002。另外类似于本文所述的其他实施例,钉1002可由被定位在仓体1062内的钉驱动器支撑,其中滑动件和/或击发构件例如可被推进穿过钉仓1060,以将钉腔1066内的钉驱动器向上提升,并且从钉腔1066中射出钉1002。
参见图34,组织厚度补偿件诸如组织厚度补偿件1000和1000’可被紧固到组织T,以便例如向紧固的组织T提供支撑。如图34所示,组织厚度补偿件1000和1000’可被紧固到组织T的相背对侧。组织厚度补偿件,诸如组织厚度补偿件1000,例如可包括内部部分1004和外部部分1006,该外部部分可形成至少部分地围绕内部部分1004的外周边。外部部分1006可比内部部分1004更具有柔性。在各种情况下,外部部分1006可具有足够的柔性以向组织T提供无创伤组织接触表面,并且内部部分可具有足够的刚性以向紧固的组织T提供足够的支撑。
再次参见图34,组织厚度补偿件1000的外部部分1006可包括外边缘1008。为了提高其柔性,外部部分1006可包括多个狭缝1010。此外,外边缘1008和外部部分1006的多个片可被切割或移除以提高外部部分1006的柔性。如图34所示,狭缝1010可开始于外边缘1008处并且可沿循终止于外部部分1006内的各种路径。例如,狭缝诸如狭缝1010A可开始于外边缘1008处,然后沿循终止于外部部分1006内的基本上垂直于外边缘1008的路径。在另一个实例中,狭缝诸如狭缝1010B也可开始于外边缘1008处,然后沿循也终止于外部部分1006内的与外边缘1008成锐角的路径。组织厚度补偿件1000可制造成具有外部部分1006中的狭缝1010。另选地,组织厚度补偿件1000可制造成不具有狭缝1010,该狭缝例如可结合到外部部分1006中,然后将其植入。
如上所述,并且如图34所示,当钉1002从其非击发位置运动到其击发位置时,钉1002被构造成能够至少部分地捕获组织厚度补偿件1000。此外,钉1002可成排击发,并且每一排可包括多个钉1002。钉1002的排,例如排1012,可被紧固到组织厚度补偿件1000的外部部分1006上,使得狭缝1010可定位在排1012的钉1002之间以允许向钉1002提供足够的支撑,同时保持外部部分1006内的足够柔性。另选地,在某些情况下,狭缝1010可定位在钉1002内,例如以提供钉1002内的柔性。
现在参见图35,组织厚度补偿件1000可包括延伸穿过其中的多个开口1014。如图35所示,开口1014可具有大体圆柱形形状。另选地,开口1014可具有锥形形状,该锥形形状可在组织厚度补偿件1000的一侧较窄,并且在另一侧较宽。可在本公开的范围内设想开口1014的其他几何形状。组织厚度补偿件1000还可包括多个腔1016。如图35所示,腔1016可具有大体圆柱形形状,有时具有渐缩外部部分。可在本公开的范围内设想腔1016的其他几何形状。例如,腔1016可包括末端闭合的锥形。开口1014和/或腔1016可在组织厚度补偿件1000内提供局部柔性的区域,并且可定位在外部部分1006、内部部分1004和/或部分1004与部分1006两者内,以增强组织厚度补偿件1000的柔性。此外,如图35所示,组织厚度补偿件1000可包括狭缝1010、开口1014和/或腔1016的组合,以产生所需程度的柔性。
现在参见图36至图39,为了提高组织厚度补偿件1000的柔性,其厚度可包括能够提供局部柔性区域的图案。此类图案可为压花图案,其可被模制或雕刻到组织厚度补偿件1000中。如图36所示,组织厚度补偿件1000可包括图案1020,该图案包括可例如成排布置的多个锥体1018。如图37所示,锥体1018可彼此分开距离“D”。组织厚度补偿件1000的柔性程度可通过增加或减小锥体1018之间的距离“D”来部分地控制。锥体1018可以其他图案布置方式来布置,所述图案布置方式可在本公开的范围内设想到。此外,还可使用并且可在本公开的范围内设想到其他几何形状(例如,锥形)以及它们的组合。如图38所示,组织厚度补偿件1000可包括波纹形图案1022。图38示出组织厚度补偿件1000的波纹形图案1022的剖视图,其可包括多个峰1024和多个谷1026。本文所示出的各种图案及其组合可定位在外部部分1006和/或内部部分1004内,以增强组织厚度补偿件1000的柔性。
进一步地,参见图40和图41,组织厚度补偿件1000的外边缘1008可包括大体无创伤轮廓,其可在例如通过钉1002捕获组织T和组织厚度补偿件1000期间和/或之后最大程度减轻施加到组织T上的负担。例如,如图40和图41所示,外边缘1008可包括大体圆齿状轮廓。例如也可在本公开的范围内设想外边缘1008的其他无创伤轮廓诸如羽状轮廓。此外,组织厚度补偿件1000还可包括无创伤前缘部分1028和/或无创伤尾部部分1030。如图40和图41所示,无创伤前缘部分1028可具有例如大体弯曲形状,并且无创伤尾部部分1030可包括例如具有柔性端部1032的裂开尾部。也可在本公开的范围内设想前缘部分1028和/或尾部部分1030的其他无创伤形状。
再次参见图40和图41,组织厚度补偿件1000可包括夹持构件1034,当组织厚度补偿件1000抵靠仓平台1064放置时,该夹持构件可减小组织厚度补偿件1000与仓平台1064之间的滑移。如图40所示,夹持构件1034可包括例如多个圆柱形的突起1036,该突起可与仓平台1064中的对应凹槽接合。如图41所示,夹持构件1034可包括箭头形状的突起1038,该突起可与仓平台1064中的对应凹槽配合。可在本公开的范围内设想用于将组织厚度补偿件1000夹持到仓平台1064的其他夹持装置。如图40和图41所示,夹持构件1034可定位在前缘部分1028中。另选地,夹持构件1034可定位在组织厚度补偿件1000的其他部分中,诸如尾部部分1030。
现在参见图42至图44,组织厚度补偿件1000的外部部分1006可包括缓冲构件1043,该缓冲构件可在例如通过钉1002捕获组织T和组织厚度补偿件1000期间和/或之后提供接触组织T的柔韧边缘。在至少一个实施例中,如图44所示,缓冲构件1043可具有足够的结构弹性以在抵靠组织T压缩时塌缩和/或弯曲。如图43所示,缓冲构件1043可在外边缘1008上方部分地延伸,并且可通过例如粘合剂附接到外边缘1008。可在本公开的范围内设想用于将缓冲构件1043附接到外边缘1008的其他附接装置。另选地,缓冲构件1043可为可与其一起制造的组织厚度补偿件1000的整体部分。缓冲构件1043可包括生物相容性泡沫,其可由可生物降解材料例如诸如PGA、PCL、PLLA、和/或它们的组合构成。此外,缓冲构件1043可至少部分地由藻酸盐和/或氧化再生纤维素(ORC)构成。例如,缓冲构件1043可包括多个藻酸盐和/或ORC珠,其可在植入患者体内时变软,这可增加缓冲构件1043的柔软性。
补偿件1000的外边缘1008可包括比外部部分1006的厚度更大的厚度。外边缘1008的更大厚度可提供接触组织T的无创伤表面。参见图45和图46,组织厚度补偿件1000的外部部分1006可包括卷曲外边缘1046,其可围绕外部部分1006至少部分地延伸并且朝向内部部分1004向内卷曲。类似于上文所述,在例如通过钉1002捕获组织T和组织厚度补偿件1000期间和/或之后,卷曲外边缘1046可提供接触组织T的柔韧外边缘。
参见图47至图49,如上所述,钉仓通道1050被构造成能够接收包括仓体1062、仓平台1064的钉仓1060。另外,组织厚度补偿件例如组织厚度补偿件1100能够可移除地定位成抵靠仓平台1064或者与仓平台1064相邻,如图47所示。
再次参见图47至图49,组织厚度补偿件在植入患者体内后被构造成能够被吸收。此吸收过程最初可使组织厚度补偿件分解成较小的片,所述片可包括对周围组织T可具有不利影响的粗糙边缘。为了减轻这些影响,组织厚度补偿件1100可至少部分地由多个片1140组装,所述片各自可具有无创伤外周边,并可接合在一起以形成单个结构,如图48所示。片1140可按照以下方式接合以形成组织厚度补偿件1100,所述方式使得吸收过程可首先使组织厚度补偿件1100分解成片1140,从而使出现粗糙边缘的可能性降至最低。例如,片1140可具有圆形轮廓,并且可通过热粘结接合在一起以形成组织厚度补偿件1100。还在本公开的范围内设想了片1140的其他轮廓以及将片1140接合在一起的其他方式。在一个实例中,可通过粘合剂1143将片1140接合在一起(参见图48),所述粘合剂被构造成能够比片1140更快地被吸收,以允许片1140在吸收过程的初始阶段便分开。如图48所示,片1140可被布置成重叠阵列,其中一个片1140的端部部分可与另一个片1140的端部部分重叠,使得片1140的两个端部部分可释放地附接到彼此,例如通过粘合剂。在某些情况下,片1140可被布置成另一种重叠阵列,其中一个片1140可定位在多个片1140上方并可释放地附接到多个片1140,如图49所示。
参见图50至图53,如上所述,组织厚度补偿件被构造成能够在植入患者体内后被吸收,并且吸收过程最初可使组织厚度补偿件随机分解成较小的片。如上所述,通过利用具有无创伤外边缘的小片开始,可实现对吸收过程的引导以产生具有无创伤外边缘的小片。另一种方法可包括以如下方式修改组织厚度补偿件,所述方式允许该组织厚度补偿件在吸收过程的初始阶段分离成具有无创伤周边的较小的片。例如,如图50所示,组织厚度补偿件1200可例如包括图案诸如图案1212,该图案可被模制到或刻入组织厚度补偿件1200中,以产生例如多个圆形部分1210。部分1210可通过沿圆形部分1210的周长1214减小组织厚度补偿件1200的厚度来限定,如图51中的剖视图所示。因此,沿圆形部分1210的周长1214可产生更快速吸收,这可使圆形部分1210在吸收过程的初始阶段彼此分开。还在本公开的范围内设想了包括具有其他几何形状和无创伤外周边的部分的其他图案。例如,如图52所示,组织厚度补偿件1200’可包括具有部分1218的图案1216,所述部分可包括沿着组织厚度补偿件1200’的长度以波形轮廓纵向延伸的轮廓。在另一个实例中,如图53所示,组织厚度补偿件1200”可包括图案1220,该图案可包括六边形形状的部分1222。
参见图54,如上所述,组织厚度补偿件诸如组织厚度补偿件1250可例如沿组织T被钉诸如钉1002捕获,并且被构造成能够例如在被植入患者体内后在吸收过程的初始阶段分解成无创伤片诸如片1226。一旦分开,片1226可相对彼此运动和/或滑动,这可影响周围组织T。为了最大程度减小片1226之间的相对运动,可使击发的钉1002在空间上布置到组织厚度补偿件1250上,使得钉1002可捕获多个片1226,如图54所示。这还可有助于组织厚度补偿件1250保持基本上单一的结构,即使在片1226在吸收过程的初始阶段中彼此分开之后。因此,在片1226在吸收过程的初始阶段中彼此分开后,组织厚度补偿件1250可继续向由钉1002捕获的组织T提供支撑。
进一步地,现在参见图55,可采用又一种方法引导组织厚度补偿件的吸收过程以产生具有无创伤外边缘的片。例如,如图55所示,组织厚度补偿件诸如组织厚度补偿件1300可包括多个狭缝1310,所述狭缝被有策略地定位,以如上所述提高组织厚度补偿件1300的柔性。另外,狭缝1310可将组织厚度补偿件1300部分地分成多个部分1312,所述部分可在吸收过程的初始阶段彼此分开。狭缝1312可沿部分1312的外周边1314减小组织厚度补偿件1300的宽度,如图55所示。宽度的减小可导致沿部分1312的外周边1314的更快速吸收,这可导致组织厚度补偿件1300在吸收过程的初始阶段分解成分开的部分1312。
总体参见图55A至图57,如上所述,钉仓通道1050被构造成能够接收例如钉仓1060,在至少一个实施例中,该钉仓能够可移除地保持在钉仓通道1050内。在各种实施例中,钉仓1060可包括仓体1062、仓平台1064和组织厚度补偿件1400,其中在至少一个实施例中,如图55A所示,组织厚度补偿件1400能够可移除地定位成抵靠或邻近仓平台1064,并且可包括突起(未示出),如上文针对与凹槽1402的配合接合所述。
再次参见图55A至图57,补偿件1400可包括多个层。例如,补偿件1400可包括第一层1400A,以及可定位在第一层1400A上方的第二层1400B。此外,第二层1400B的外周边1418可至少部分地延伸超过第一层1400A的外周边1420。此外,第一层1400A和第二层1400B可具有不同程度的刚度。例如,第二层1400B被构造成能够比第一层1400A更具柔性。如图55B所示,这种布置可使组织厚度补偿件1400具有足够刚性的内部区域和足够柔性的外部区域,所述内部区域由第一层1400A和第二层1400B构成,其可适于向钉1002提供充分支撑;所述外部区域由第二层1400B构成,其可适于提供足够的柔性,以例如在组织T和组织厚度补偿件1400被钉1002捕获期间和/或之后减轻组织T上的负担。层1400A和层1400B可例如通过粘合剂接合在一起。可在本公开的范围内设想用于将第一层1400A附接到第二层1400B的其他附接装置。
进一步地,再次参见图55A,第一层1400A可包括内部部分1404和至少部分地围绕内部部分1404的外部部分1406,其中外部部分1406被构造成能够比内部部分1404更具柔性。例如,如图55A所示,外部部分1404可包括多个狭缝1410,如上所述,该狭缝可增加外部部分1404的柔性。此外,如上所述,第二层1400B被构造成能够比第一层1400A更具柔性。这种布置方式可向组织厚度补偿件1400提供具有不同刚性的三个区域,包括具有最大刚性的第一内部区域,该内部区域由第一层1400A和第二层1400B的内部部分1404构成;具有中等刚性的中间区域,该中间区域由第一层1400A和第二层1400B的外部部分1408构成;以及具有最小刚性的第三外部区域,该第三区域仅由第二层1400B构成。
现在参见图56和图57,组织厚度补偿件1400的第二层1400B可包括织造结构1440,该织造结构可包括可织造成织造结构1440的多根纤维1442。织造结构1440可提供具有足够柔性的第二层1400B,以便例如在被钉1002捕获组织T和组织厚度补偿件1400期间和/或之后减轻组织T上的负担。此外,外周边1418可由纤维1042构成,所述纤维可提供无创伤组织接触表面,从而如上所述最大程度减轻组织T上的负担。织造结构1440和纤维1042可由生物相容性材料构成。此外,织造结构1040和/或纤维1042可例如由可生物吸收的材料诸如PLLA、PGA、PCL和/或它们的组合构成。
现在参见图60至图60B,如下文更详细所述,组织厚度补偿件11050可包括近侧端部11053和远侧端部11055,其中近侧端部11053和/或远侧端部11055可包括一个或多个应变消除部分,该应变消除部分可减小组织厚度补偿件11050的刚性以及被缝合的组织的刚性。组织厚度补偿件11050的远侧端部11055可包括限定于其中的一个或多个狭槽11058。狭槽11058可例如包括限定于组织厚度补偿件11050中的切口和/或凹口。狭槽11058可限定突出部或接片11056,所述突出部或接片被构造成能够相对于彼此和/或组织厚度补偿件11050的主体部分至少部分地运动和/或挠曲。换句话说,狭槽11058可向组织厚度补偿件11050和下面的组织提供局部应变消除。在某些情况下,第一组织厚度补偿件11050的接片11056可与第二组织厚度补偿件11050的近侧端部11053重叠。在各种情况下,狭槽11058可允许第一组织厚度补偿件11050和第二组织厚度补偿件11050相对彼此枢转。在某些情况下,主要参见图60B,第一组织厚度补偿件11050的接片11056可与第二组织厚度补偿件11050的接片11056重叠。在各种情况下,重叠的远侧端部11055中的狭槽11058还可降低下面的组织的刚性。虽然组织厚度补偿件11050的示出实施例只在其一端布置有接片11057和狭槽11058,但该组织厚度补偿件也可例如在其两端布置有接片11056和狭槽11058。
在某些实施例中,进一步地,每个接片11056可包括渐缩的轮廓。例如,每个接片11056可包括基部和位于其相对端的自由端,该基部附接到组织厚度补偿件11050的主体并具有基部宽度,该自由端具有端部宽度,其中基部宽度可比端部宽度宽。在某些实施例中,端部宽度可比基部宽度宽。主要参见图60B,端部11055可包括多个接片11056,该接片具有不同构型。例如,接片11056可具有不同的长度。如图60B所示,例如,最末端的接片11056a可具有第一长度,第二个接片11056b可具有比第一长度长的第二长度,第三个接片11056c可具有比第二长度长的第三长度,第四个接片11056d可具有比第三长度长的第四长度,第五个接片11056e可具有比第四长度长的第五长度,第六个接片11056f可具有比第五长度长的第六长度。在此类实施例中,接片11056可朝组织厚度补偿件11050的远侧端部逐渐地变短。在其他实施例中,接片11056长度可按照任何其他合适的布置方式来布置。
在各种情况下,进一步地,层可包括限定层的周边的边缘。在某些情况下,这些边缘可为笔直的、基本上笔直的、线性的、和/或基本上线性的。在一些此类情况下,层边缘可冲击和/或以其他方式影响周围组织。另外,在一些此类情况下,边缘可为刚性的,并且可刚性地支撑组织。实际上,组织的某些部分不受该层支撑,所述部分与组织的由该层刚性支撑的其他层相邻,两个部分之间没有过渡。再次参见图60至图60B,组织厚度补偿件11050的周边可具有波状构型,该波状构型可向下方组织提供具有渐变刚性的区域。组织厚度补偿件11050的周边可包括限定于其中的多个凹口或凹槽11059,所述凹口或凹槽可限定接片11057。类似于上文所述,接片11057可从组织厚度补偿件11050的主体延伸,并可相对于主体运动。同样类似于上文所述,每个接片11057可包括基部端部和自由端,该基部端部附接到组织厚度补偿件11050的主体,该自由端部能够相对于基部端部运动。在某些情况下,接片11057的自由端的宽度可比接片11057的基部端部的宽度窄,而在其他情况下,接片11057的自由端的宽度可比接片11057的基部端部的宽度宽。接片11057可例如具有任何合适的构型,诸如半圆形构型,或至少部分地弓形构型。鉴于上文所述,位于组织厚度补偿件11050的主体部分下面和/或紧固到其的组织可由主体部分刚性地支撑,位于接片11057下面和/或紧固到其的组织可由接片11057较小刚性的支撑,并且与接片11057相邻但不位于接片11057下面的组织可不由组织厚度补偿件11050支撑。
现在参见图58和图59,钉仓组件11100可包括仓体11110和附接到仓体11110的组织厚度补偿件11150。仓组件11100还可包括一个或多个附接构件11160,该附接构件11160被构造成能够将组织厚度补偿件11150可释放地保持到仓体11110。在至少一种情况下,每个附接构件可包括条带,该条带围绕仓体11110和组织厚度补偿件11150延伸。在使用中,进一步地,击发构件10030可被推进穿过钉仓11100以切入组织厚度补偿件11150,将至少部分地储存在仓体11110中的钉击发,并且将附接构件11160切断。组织厚度补偿件11150可包括第一或近侧端部11157和第二或远侧端部11155。远侧端部11155可包括细长突出部11156,该突出部从组织厚度补偿件11150的主体部分11153延伸。如图58所示,该细长突出部11156可相对于最远侧附接构件11160朝远侧延伸。在至少示出的实施例中,仓体11110可包括平台11113,在该平台内可限定有仓体11110的钉腔。在各种情况下,组织厚度补偿件11150的主体11153被构造成能够并被布置成覆盖限定于仓体11110中的平台11113和钉腔。在至少一些情况下,同样如图58所示,细长突出部11156可从平台11113朝远侧延伸,并相对于被限定在平台11113中的钉腔朝远侧延伸。
在使用中,进一步地,组织厚度补偿件11150可如本文所述紧固到组织,并且可提供组织厚度补偿特性。类似于上文所述,位于组织厚度补偿件11150下面的组织可被组织厚度补偿件11150和固定该组织的钉刚性支撑,而围绕组织厚度补偿件11150的组织可不由组织厚度补偿件11150支撑并且可为柔性的。在此类情况下,在未支撑的柔性组织和位于组织厚度补偿件11150下面被刚性支撑的组织之间的组织即过渡组织可经历不期望程度的应变。此类应变可对过渡组织产生不利影响。例如,在将组织厚度补偿件固定到例如肺组织后,立即围绕住组织厚度补偿件的周边的组织,即周边组织,在某些情况下可撕裂,尤其是邻近和/或围绕组织厚度补偿件的远侧端部的周边组织,即端部周边组织。然而,组织厚度补偿件11150的远侧突出部11156可支撑端部周边组织。换句话讲,远侧突出部11156可向端部周边组织提供过渡支撑。此类过渡支撑可小于组织厚度补偿件11150的主体提供的支撑,并且可减轻未支撑组织与组织厚度补偿件11150下面的被充分支撑的组织之间的应变改变。在各种情况下,远侧突出部11156提供扩大区域,在该扩大区域中,力可在未缝合组织与已缝合组织之间传递。远侧突出部11156被构造成能够挠曲并与未支撑组织和组织厚度补偿件11150一起运动。在各种情况下,远侧突出部11156可相对于组织厚度补偿件11150的主体部分和/或未支撑组织运动。
再次参见图58和图59,组织厚度补偿件11150还可包括限定于其近侧端部11153中的凹口11157。凹口11157可限定于两个朝远侧延伸的突出部11158之间。凹口11157可例如具有任何合适的形状,诸如抛物线形状。类似于上文所述,朝远侧延伸的突出部11158可向近侧端部周边组织提供过渡支撑。此类过渡支撑可小于组织厚度补偿件11150的主体提供的支撑,并且可减轻未支撑组织与组织厚度补偿件11150下面的被充分支撑组织之间的应变改变。在各种情况下,近侧突出部11158可提供扩大区域,在该扩大区域中,力可在未缝合组织与已缝合组织之间传递。近侧突出部11158被构造成能够挠曲并与未支撑组织和组织厚度补偿件11150一起运动。在各种情况下,近侧突出部11158可相对于组织厚度补偿件11150的主体部分、相对于彼此、和/或相对于未支撑组织运动。还设想了从组织厚度补偿件的近侧端部和/或远侧端部延伸的多于两个的突出部的各种另选实施例。
如图59所示,可沿路径以端部对端部的方式植入两个或更多个组织厚度补偿件11150。在此类情况下,第一组织厚度补偿件11150的远侧端部11155可与第二组织厚度补偿件11150的近侧端部11153重叠。类似地,第二组织厚度补偿件11150的远侧端部11155可与第三组织厚度补偿件11150的近侧端部11153重叠。在各种情况下,第一组织厚度补偿件11150的远侧突出部11156可与第二组织厚度补偿件11150的凹槽11157对准、或至少大致对准。另外,在各种实施例中,远侧突出部11156和近侧凹槽11158的尺寸可设定成并且被构造成能够使得它们具有基本上相同的尺寸和/或形状。在各种情况下,远侧突出部11156被构造成能够定位在相邻组织厚度补偿件11150的近侧凹槽11157内。
在各种实施例中,现在参见图61,钉仓组件16000可包括仓体16010和层组件16020。仓体16010可包括平台16011和限定在平台16011中的纵向狭槽16012,该纵向狭槽被构造成能够在其中可滑动地接收切割构件16030。仓体16010还可包括限定在其中的多个钉腔,所述钉腔各自被构造成能够将钉可移除地储存在其中。钉腔可为两个或更多个组的一部分。例如,钉腔可被分成第一组钉腔16015和第二组钉腔16016。在各种情况下,钉腔组可按排来布置,而在其他情况下,钉腔组可彼此重叠或相互分散。在任一种情况下,层组件16020可包括可在钉腔上方延伸的多个层。在使用中,如下文进一步更详细地描述,当钉从钉腔射出时,钉可将层组件16020的至少一部分捕获在其中。层组件16020的层被构造成能够使得层组件16020的仅某些层在某些钉腔上方延伸。例如,层组件16020可包括可在第一组钉腔16015和第二组钉腔16016上方延伸的第一层16050,另外还包括可在第二组钉腔16016上方延伸但可不在第一组钉腔16015上方延伸的第二层16040。
在使用中,作为上述的结果,并主要参见图62,从钉仓16000部署的某些钉可捕获层组件16020的仅第一层16050,而其他钉可捕获层组件16020的仅第二层16040。例如,一个或多个外钉排16061可捕获仅第一层16050,而一个或多个内钉排16063可捕获第一层16050和第二层16040两者。在各种实施例中,一个或多个中间钉排16062可包括捕获仅第一层16050的一些钉以及捕获第一层16050和第二层16040两者的其他钉。在至少一个实施例中,第二层16040可包括被构造成能够被捕获在中间排钉16062内的多个接片16043。接片16043可由狭槽16044分开,该狭槽可允许接片16043相对于彼此运动和挠曲。例如,狭槽16044和接片16043的布置方式可在缝合组织内引入柔性。在某些实施例中,接片16043可充分地间隔开,使得中间钉16062的一些可将接片16043捕获在其中,而其他钉则不可。再次主要参见图61,第二层16040可包括从其延伸的纵向突出部16042,该突出部被构造成能够延伸到限定于仓体16010中的纵向狭槽16012中。在各种情况下,纵向突出部16042能够可释放地固定或在纵向狭槽16012内。在至少一个实施例中,纵向突出部16042可经由例如压力配合接合而紧密配合在纵向狭槽16012内。在任何情况下,纵向狭槽16012与纵向突出部16042之间的接合可保持第二层16040与仓体16010之间的对齐。此外,第一层16050可安装到第二层16040,使得突出部16042还可将第一层16050保持在适当位置。
进一步地,层组件16020的第一层16050可覆盖第一组钉腔,并且第二层16040可覆盖第二组钉腔。换句话说,层组件16020的第一层16050可具有与第二层16040不同的占用面积。在各种实施例中,层组件16020的第一层16050和第二层16040可由不同材料构成。在至少一个此类实施例中,第二层16040可包括刚性材料并且被构造成能够支撑第一层16050。第一层16050可由柔性材料、或至少比构成第二层16050的材料更具柔性的材料构成。主要参见图62,柔性第一层16050可侧向延伸超过第二层16040。在此类情况下,第一层16050可提供层组件16020的更柔性侧向边缘。在层组件16020已通过钉抵靠组织T植入并且由切割构件16030切断之后,主要参见图62,第二层16050可支撑与切断线相邻定位的组织T,而第一层16040可在组织T旁边侧向延伸离开。在各种情况下,第一层16040可提供被第二层16050支撑的组织T与未被层组件16020支撑的组织T之间的柔性过渡。在各种情况下,第一层16050可包括组织厚度补偿件,并且第二层16040可包含例如层合材料。
在各种实施例中,主要参见图61,层组件16020可附接到仓体16010。在至少一个实施例中,仓组件16000可包括至少一个系结或连接器,其可将层组件16020可释放地保持到仓体16010。例如,仓组件16000可包括将层组件16020的远侧端部16021可释放地保持到仓体16010的远侧端部的第一连接器和将层组件16020的近侧端部16022保持到仓体16010的近侧端部的第二连接器。在将击发构件16030从仓体16010的近侧端部推进到远侧端部以从其部署钉并且切入层组件16020时,击发构件16030还可切断和/或以其他方式克服将层组件16020保持到仓体16010的连接器。
现在参见图64至图66,端部执行器组件5400可包括第一钳口(在别处示出)和第二钳口5402。在各种实施例中,第二钳口5402可包括紧固件仓体5450和可释放地固定到紧固件仓体5450和/或第二钳口5402的材料层5458。紧固件仓体5450和可释放地固定到其上的材料层5458可例如构成紧固件仓组件。在各种实施例中,材料层5458可包括例如支撑材料片和/或组织厚度补偿件。在某些实施例中,材料层5458可为例如可释放地固定到紧固件仓体5450的支撑材料片。第二钳口5402可具有近侧部分5404和远侧部分5406。在各种实施例中,第二钳口5402可具有位于近侧部分5404处的近侧连接器5480a(图65和图66)和位于远侧部分5406处的远侧连接器5480b(图66)。近侧连接器5480a和远侧连接器5480b可相对于仓体5450固定材料层5458。连接器5480a,5480b可包括例如带和/或绳索。
主要参见图64,仓体5450可包括平台5452。狭槽5456可例如从第二钳口5402的近侧部分5404朝向远侧部分5406延伸,并且可被限定在例如平台5452的一部分中。在各种实施例中,紧固件腔5454也可被限定在平台5452中。另外,第二钳口5402可包括可移除地定位在紧固件腔5454中的例如紧固件,诸如外科缝合器。举例来说,紧固件能够以可射出的方式定位在仓体5450的每个紧固件腔5454中。在各种实施例中,紧固件可在击发行程期间通过滑动件5434从其相应的紧固件腔5454射出(图65和图66)。
主要参见图65和图66,击发组件5430可包括击发杆5432、切割刃5436和支脚5438。切割刃5438可切割例如组织和/或材料层5458,并且支脚5438可例如沿着仓体5450中的狭槽5456引导击发组件5430(图64)。在各种实施例中,击发组件5430可在击发行程期间沿着仓体5450中的狭槽5456运动。击发组件5430可接合仓体5430中的滑动件5434并且可驱动滑动件5434至少部分地穿过例如仓体5450。在某些实施例中,滑动件5434可具有能够在击发行程期间接合紧固件腔5454中的驱动器的凸轮表面或斜坡5442。当斜坡5442接合紧固件腔5454中的驱动器时,斜坡5442可使驱动器和相应的紧固件朝向仓平台5452进行凸轮运动,并且可例如使紧固件从紧固件腔5454射出。在某些实施例中,主要参见图65,在击发行程开始时,击发组件5430可定位在第二钳口5402的近侧部分5404处。在此类实施例中,主要参见图66,击发杆5432可在击发行程期间朝远侧驱动击发组件5430。在各种实施例中,切割刃5436可在击发行程期间切割近侧连接器5480a和远侧连接器5480b。切割刃5436可例如在击发行程开始时和/或开始一会儿后切割近侧连接器5480a,并且可例如在击发行程结束时或将要结束时切割远侧连接器5080b。
仍参见图64至图66,材料层5458可通过近侧连接器5480a(图65)并通过远侧连接器5480b(图65和图66)被固定到仓体5450的平台5452(图64)。此外,材料层5458可包括至少一个安装件5460。安装件5460可例如与材料层5458一体成型。在某些实施例中,当材料层5458被固定到平台5452时,安装件5460可从材料层5458延伸到仓体5450的狭槽5456中。主要参见图65,安装件5460可例如延伸到近侧连接器5480a与远侧连接器5480b之间的狭槽5456(图64)中。换句话讲,安装件5460可从材料层5458的中间部分5468延伸。在各种实施例中,当将材料层5458定位在仓体5450的平台5452上时,安装件5460的尺寸可设定成配合到狭槽5456中。此外,当将材料层5458从仓体5450提起和/或剥离时,安装件5460的尺寸可设计成用于从狭槽5456非强制移除。例如,安装件5460可不摩擦配合在狭槽5456中,在某些实施例中,当安装件5460定位在狭槽5456中时,安装件5460和狭槽5456之间可存在空隙或间隙。空隙可例如为大约0.12mm。在某些实施例中,空隙可例如最多至大约0.24mm。在一些实施例中,例如在安装件5460与狭槽5456之间可存在大约0.01mm至大约0.12mm的过盈,使得安装件5460例如在定位在例如狭槽5456中时被压缩。
仍参见图64至图66,安装件-狭槽接合可防止和/或限制材料层5458的中间部分5468的侧向移位和/或屈曲。例如,当端部执行器组件5400相对于手术部位处的组织放置和/或运动时,安装件5460可保持定位在狭槽5456(图64)内,以相对于仓平台5452将中间部分5468保持在适当位置。材料层5458的一些移位可能是由于例如限定在安装件5460与狭槽5456之间的空隙。在各种实施例中,安装件5460可不抵抗远离仓体5450提起和/或剥离材料层5458。例如,安装件5460可不摩擦配合在狭槽5456中,并且当将材料层5458远离仓体5450的平台5452被提起时,例如在切割刃5436切割近侧连接器5680a和远侧连接器5680b之后,安装件5460可易于从狭槽5456移除。例如,当击发组件5430在击发行程期间朝远侧驱动时,击发组件5430的元件可接触狭槽5456内的安装件5460。主要参见图66,当滑动件5434被击发组件5430朝远侧驱动时,滑动件5434可接触安装件5460。另外,滑动件5434可使安装件5460挠曲离开滑动件的路径并且离开狭槽5456。换句话讲,滑动件5434可使安装件5460挠曲以从狭槽5456移除安装件5460。
在各种实施例中,材料层5458可包括多个安装件5460,其可从材料层5458延伸到仓体5450中的狭槽5456(图64)中。安装件5460可例如沿着狭槽5456的长度的至少一部分间隔。在某些实施例中,至少一个安装件5460可定位在第二钳口5402的近侧部分5404中,并且至少一个安装件5460可定位在第二钳口5402的远侧部分5406中。另外,安装件5460可例如定位在近侧连接器5480a与远侧连接器5480b中间(图65)。当击发组件5430(图65和图66)在击发行程期间朝远侧击发时,滑动件5434可依次接合狭槽5456中的每个安装件5460,以使每个安装件5460挠曲并从狭槽5456移除。当每个安装件5460从狭槽5456释放并且近侧连接器5480a与远侧连接器5480b被切割或以其他方式被克服时,材料层5458相对于仓体5450的平台5452可未固定。
仍参见图64至图66,安装件5460可包括柔性杆5462和头部5464。当击发组件5430的元件诸如滑动件5434在击发行程期间推压头部5464时,安装件5460的柔性杆5462可挠曲。在某些实施例中,头部5464可具有放大的圆形形状,以使头部5464与仓体5450的狭槽5456之间的空隙最小。在各种实施例中,头部5464可配合在狭槽5456内,并且当将材料层5458远离仓体5450提起和/或剥离时可容易且平滑地从狭槽5456移除。
现在参见图67至图70,端部执行器组件5500可包括第一钳口(在别处示出)和第二钳口5502。在各种实施例中,第二钳口5502可包括仓体5450和可释放地固定到仓体5450和/或第二钳口的材料层5558。仓体5450和可释放地固定到其上的材料层5558可例如构成紧固件仓组件。在各种实施例中,材料层5558可包括例如支撑材料片和/或组织厚度补偿件。在某些实施例中,材料层5558可为可释放地固定到仓体5450的支撑材料片。另外,第二钳口5502可具有近侧部分5504和远侧部分5506。在各种实施例中,第二钳口5502可具有位于近侧部分5504处的近侧连接器5580a(图68和图69)和位于远侧部分5506处的远侧连接器5580b(图68)。近侧连接器5580a和远侧连接器5580b可相对于仓体5450固定材料层5558。在各种实施例中,材料层5558可包括脊5560。脊5560可例如与材料层5558一体成型。主要参见图67,脊5560可沿着材料层5558的长度的至少一部分纵向延伸。
主要参见图69,当材料层5558被固定到仓体5460时,脊5560可延伸到仓体5450的狭槽5456中。脊5560可延伸到例如近侧连接器5580a与远侧连接器5580b之间的狭槽5456中。在各种实施例中,当将材料层5558定位在仓体5450上时,脊5560的尺寸可设定成配合在狭槽5456中。此外,当将材料层5558远离仓体5458提起和/或剥离时,脊5560的尺寸可设定成用于从狭槽5456非强制移除。例如,脊5560可不摩擦配合在狭槽5456中,并且在某些实施例中,当脊5560与狭槽5456一起定位时,脊5560和狭槽5456之间可存在空隙或间隙。空隙可例如为大约0.08mm。在某些实施例中,空隙可例如最多至大约0.24mm。在一些实施例中,例如在脊5560与狭槽5456之间可存在大约0.01mm至大约0.06mm的过盈,使得脊5560例如在定位在例如狭槽5456中时被压缩。
在各种实施例中,脊-狭槽接合可防止和/或限制材料层5558相对于仓体5450的平台5452的侧向移位和/或屈曲。例如,当端部执行器组件5500相对于手术部位处的组织放置和/或运动时,脊5560可保持定位在狭槽5456中,以相对于仓平台5452将材料层5558保持在适当位置。材料层5558相对于仓体5450的一些移位可能是由于例如限定在脊5560与狭槽5456之间的空隙。在各种实施例中,脊5560可不抵抗远离仓体5450提起和/或剥离材料层5558。例如,脊5560可不摩擦配合在狭槽5456中,并且当将材料层5550远离仓体5450的平台5452提起时,例如在切割刃5436切割近侧连接器5680a和远侧连接器5680b之后,脊5560可容易且平滑地从狭槽5456移除。在各种实施例中,当切割刃5436在击发行程期间朝远侧驱动时,击发组件5430的切割刃5436可切割例如材料层5558,以及脊5560。
主要参见图68至图70,材料层5558可包括加强特征结构5570,其可沿着材料层5558的长度的至少一部分延伸。加强特征结构5570可例如从第二钳口5502的近侧部分5504朝向第二钳口5502的远侧部分5506延伸。加强特征结构5570可例如与材料层5558一体成型。在各种实施例中,加强特征结构5570可增大材料层5558的惯性矩,使得加强特征结构5570可加强、支撑和/或硬化材料层5558。例如,当切割刃5436(图65和图66)在击发行程期间横穿材料层5558时,加强特征结构5570可防止和/或限制材料层5558相对于仓体5450的移位和/或屈曲。另外,加强特征结构5570可接合夹紧在端部执行器组件5500的第一钳口与第二钳口5502之间的组织。在某些实施例中,加强特征结构5570可例如防止和/或限制夹紧组织相对于仓体5450的移位。在各种实施例中,材料层5558可包括多个加强特征结构5570,其可沿着材料层5558的长度的至少一部分延伸。加强特征结构5570可例如为平行的,并且可例如在脊5560的任一侧或两侧上延伸。在各种实施例中,加强特征结构5570和/或脊5560可沿着材料层5558的长度的一部分延伸,并且可在到达其远侧部分之前停止。在远侧部分处没有加强特征结构5570和/或脊5560可为材料层5558的远侧部分提供柔性。
现在参见图71,与端部执行器组件一起使用的材料层5588可具有例如类似于脊5560的纵向脊5590。在各种实施例中,材料层5588和/或脊5590可为例如支撑材料片和/或组织厚度补偿件。脊5590可沿着材料层5558的长度的至少一部分延伸。另外,脊5590可被接收在例如端部执行器中的狭槽内,诸如仓体5450中的狭槽5456(图67)。在某些实施例中,脊5590可向材料层5588提供足够的加强、支撑和刚性,而不用增加例如补充加强特征结构。
现在参见图72至图75,端部执行器组件5600可包括第一钳口(在别处示出)和第二钳口5602。在各种实施例中,第二钳口5602可包括仓体5450和可释放地固定到仓体5450和/或第二钳口5602的材料层5658。在各种实施例中,仓体5450和可释放地固定到其上的材料层5458可例如构成紧固件仓组件。材料层5658可包括例如支撑材料片和/或组织厚度补偿件。在某些实施例中,材料层5658可为例如可释放地固定到仓体5450的支撑材料片。另外,第二钳口5602可具有近侧部分5604和远侧部分5606。在各种实施例中,第二钳口5602可具有位于近侧部分5604处的近侧连接器5680a(图73和图74)和位于远侧部分5606处的远侧连接器5680b(图73)。近侧连接器5680a和远侧连接器5680b可相对于仓体5450固定材料层5658。在各种实施例中,材料层5658可包括脊5660。脊5660可例如与材料层5658一体成型。主要参见图72,脊5660可沿着材料层5658的长度的至少一部分纵向延伸。在各种实施例中,脊5660可为材料层5658的折叠部分。例如,材料层5658可在其自身上卷曲、起皱和/或折叠以形成较厚的部分,该部分可为脊5660。主要参见图74和图75,脊5660可折叠成例如U形,并且可包括倒圆顶端5662。
主要参见图74,当材料层5658被固定到仓体5460时,脊5660可延伸到仓体5450的狭槽5456中。在某些实施例中,狭槽5456的结构可被设计成接收脊5660。当将材料层5658定位在仓体5450上时,脊5660的尺寸可设定成配合到狭槽5456中。此外,当将材料层5658远离仓体5458提起和/或剥离时,脊5660的尺寸可设定成用于从狭槽5456非强制移除。例如,脊5660可不摩擦配合在狭槽5456中,并且在某些实施例中,当脊5660被定位在狭槽5456内时,脊5660和狭槽5456之间可存在空隙或间隙。空隙可例如为大约0.12mm。在某些实施例中,空隙可例如最多至大约0.24mm。在一些实施例中,例如在脊5660与狭槽5456之间可存在大约0.01mm至大约0.18mm的过盈,使得脊5660例如在定位在例如狭槽5456中时被压缩。
在各种实施例中,脊-狭槽接合可防止和/或限制材料层5658的侧向移位和/或屈曲。例如,当端部执行器组件5600相对于手术部位处的组织放置和/或运动时,脊5660可保持定位在狭槽5456中,以相对于仓平台5452将材料层5658保持在适当位置。材料层5658相对于仓体5450的移位可由空隙限制。例如,材料层5658的一些移位可能是由于限定在脊5660与狭槽5456之间的空隙。在各种实施例中,脊5660可不抵抗远离仓体5450提起和/或剥离材料层5658。例如,脊5660可不摩擦配合在狭槽5456中,并且当将材料层5658远离仓体5450的平台5452提起时,例如在切割刃5436切割近侧连接器5680a和远侧连接器5680b之后,脊5660可易于从狭槽移除。在各种实施例中,当击发组件5430(图65和图66)在击发行程期间沿着狭槽5456击发时,击发组件5430的滑动件5434和/或另一个元件可例如容易且平滑地从狭槽5456释放脊5660,以从仓体5450释放材料层5658。当切割刃5436在击发行程期间朝远侧驱动时,击发组件5430的切割刃5436可切割例如材料层5658以及脊5660。
主要参见图73至图75,材料层5658可包括加强特征结构5670,其可沿着材料层5658的长度的至少一部分延伸。加强特征结构5670可例如从第二钳口5602的近侧端部延伸到第二钳口5602的远侧端部。加强特征结构5670可例如与材料层5658一体成型。在各种实施例中,加强特征结构5670可为材料层5658的折叠部分。例如,材料层5658可在其自身上起皱、卷曲和/或折叠以形成较厚的部分,该部分可形成加强特征结构5670。主要参见图74和图75,加强特征结构5670可卷曲成V形形状,并且可包括例如尖的顶端5672。在各种实施例中,加强特征结构5670可加强、支撑和/或硬化材料层5658。在一些实施例中,加强特征结构5670被构造成能够沿着其顶端5672弯曲,以抵抗沿着材料层5658的边缘施加的侧向力,使得材料层5658保持定位在仓体5450上。例如,当切割刃5436(图65和图66)在击发行程期间横穿材料层5658时,加强特征结构5670可防止和/或限制材料层5658相对于仓体5450的移位和/或屈曲。另外,加强特征结构5670可接合夹紧在端部执行器组件5600的第一钳口与第二钳口5602之间的组织。例如,加强特征结构5670可防止和/或限制夹紧组织相对于仓体5450的移位。尖的顶端5672可接合组织,并且可例如在击发行程期间相对于材料层5658将组织保持在适当位置。在各种实施例中,材料层5658可包括多个加强特征结构5670,其可沿着材料层5658的长度的至少一部分延伸。加强特征结构5670可例如为平行的,并且可例如在脊5660的任一侧或两侧上延伸。
现在参见图76和图77,端部执行器组件5700可包括第一钳口(在别处示出)和第二钳口5702。在各种实施例中,第二钳口5702可包括仓体5750和可释放地固定到仓体5750和/或第二钳口5702的材料层5758。在各种实施例中,仓体5750和可释放地固定到其上的材料层5758可例如构成紧固件仓组件。材料层5758可包括例如支撑材料片和/或组织厚度补偿件。在某些实施例中,材料层5758可为例如可释放地固定到仓体5750的支撑材料片。第二钳口5702可具有近侧部分5704和远侧部分5706。在各种实施例中,第二钳口5702可具有位于近侧部分5704处的近侧连接器5780a(图77)和位于远侧部分5706处的远侧连接器5780b(图77)。近侧连接器5780a和远侧连接器5780b可相对于仓体5750固定材料层5758。
主要参见图76,仓体5750可包括平台5752。狭槽5756可例如从第二钳口5702的近侧部分5704朝向远侧部分5706延伸,并且可被限定在例如平台5752的一部分中。在各种实施例中,紧固件腔5754可被限定在平台5752中。第二钳口5702还可包括可移除地定位在紧固件腔5754中的紧固件,诸如外科缝合器。例如,紧固件能够以可射出的方式定位在仓体5750的每个紧固件腔5754中。在各种实施例中,紧固件可在击发行程期间通过类似于滑动件5434的滑动件从仓体5750中其相应的紧固件腔5754射出(图65和图66)。
仍参见图76和图77,击发组件诸如击发组件5430(图65和图66)可在击发行程期间沿着仓体5750中的狭槽5756运动。如上所述,击发组件5430可包括例如击发杆5432、切割刃5436、和支脚5438(图65和图66)。在各种实施例中,击发组件5430可接合仓体5730中的滑动件,并且可在击发行程期间驱动滑动件至少部分地穿过仓体5750。在某些实施例中,滑动件可具有能够在击发行程期间接合紧固件腔5754中的驱动器的凸轮表面或斜坡。当斜坡接合紧固件腔5754中的驱动器时,斜坡可使驱动器和对应的紧固件朝向仓平台5752进行凸轮运动,并且可例如使紧固件从紧固件腔5754射出。在各种实施例中,切割刃5436可在击发行程期间切割近侧连接器5780a和远侧连接器5780b(图77)。切割刃5436可例如在击发行程开始时和/或开始一会儿后切割近侧连接器5780a,并且可例如在击发行程结束时或将要结束时切割远侧连接器5780b。
仍参见图76和图77,材料层5758可通过近侧连接器5780a并且通过远侧连接器5780b可释放地固定到仓体5750的平台5752(图77)。在各种实施例中,仓体5750可包括至少一个凹口5748a(图76),其可例如被限定在平台5752中。凹口5748a可例如被定位在近侧连接器5780a和远侧连接器5780b之间。另外,在各种实施例中,材料层5758可包括安装件5760a(图76),其可例如与材料层5758一体成型。在某些实施例中,当材料层5758被固定到平台5752时,安装件5760a可从材料层5758延伸到仓体5750的凹口5748a中。安装件5760a可保持定位在凹口5748a内,以相对于仓体5750的平台5752保持材料层5758。当材料层5758定位在仓体5750上时,安装件5760a的尺寸可设定成配合在凹口5748a中。此外,当材料层5758远离仓体5758提起和/或剥离时,安装件5760a的尺寸可设定成用于从凹口5748a非强制移除。例如,安装件5760可不摩擦配合在凹口5748a中,并且在某些实施例中,当安装件5760a定位在凹口5748a中时,安装件5760a和凹口5748a之间可存在空隙或间隙。空隙可例如为大约0.08mm。在某些实施例中,空隙可例如最多至大约0.24mm。在一些实施例中,例如在安装件5760a与凹口5748a之间可存在大约0.01mm至大约0.06mm的过盈,使得安装件5760a例如在定位于凹口5748a中时被压缩。
在各种实施例中,安装件-凹口接合可防止和/或限制材料层5758相对于仓体5750的侧向移位和/或屈曲。例如,当端部执行器组件5700相对于手术部位处的组织放置和/或运动时,并且/或者当切割刃5436(图65和图66)切割材料层5758时,安装件5760a可保持定位在凹口5748a中,以相对于仓平台5752将材料层5758保持在适当位置。在某些实施例中,材料层5758相对于仓体5750的移位可由限定在安装件5760a与凹口5748a之间的空隙限制。例如,材料层5758的一些移位可能是由于空隙造成的。另外,在切割刃5436切割近侧连接器5780a和远侧连接器5780b之后,安装件5760a可在将材料层5758远离仓体5750提起和/或剥离时从凹口5748a平滑地脱离和/或移除。
主要参见图76,仓体5750可包括至少一对凹口5748a,5748b,并且材料层5758可包括一对安装件5760a,5760b。第一凹口5748a可例如定位在仓体5750的第一纵向侧上,并且第二凹口5748b可例如定位在仓体5750的第二纵向侧上。换句话讲,该对凹口5748a,5748b中的每个凹口可定位在仓体5750中的狭槽5756的相对侧上。在某些实施例中,第二凹口5748b可例如为第一凹口5748a跨过狭槽5756的镜像反射。另外,当材料层5758被固定到仓体5750时,该对安装件5760a,5760b中的每个安装件可与该对凹口5748a,5748b中的凹口对准,使得第一安装件5760a延伸到第一凹口5748a中,并且第二安装件5760b延伸到第二凹口5748b中。在各种实施例中,仓体5750中的该对凹口5748a,5748b可定位在仓体5750的周边处。另外,在某些实施例中,该对安装件5760a,5760b可定位在材料层5758的周边处。
在各种实施例中,仓体5750的两侧上的安装件-凹口接合可进一步防止和/或限制材料层5758的两个纵向侧的侧向移位和/或屈曲。例如,当击发组件5430的切割刃5436(图65和图66)切割材料层5758时,该对安装件5760a,5760b可保持定位在该对凹口5748a,5748b中,以相对于仓平台5752的周边将材料层5758的周边保持在适当位置。换句话讲,该对安装件5760a,5760b可防止材料层5758的至少一部分相对于仓平台5752侧向滑移。另外,在将材料层5758远离仓体5750提起和/或剥离时,例如在切割刃5436切割近侧连接器和远侧连接器之后,该对安装件5760a,5760b可从该对凹口5748a,5748b容易且平滑地移除。在各种实施例中,材料层5758可包括多对安装件5760a,5760b,并且仓体5750可包括多对凹口5748a,5748b。当将材料层5758固定到仓体5750时,材料层5758的每对安装件5760a,5760b可例如与一对凹口5748对准。在此类实施例中,沿着较低钳口5702的一定长度的周边的安装件-凹口接合可进一步防止和/或限制一定长度的材料层5758相对于仓体5750的侧向移位和/或屈曲。
现在参见图78至图80,端部执行器组件5800可包括第一钳口(在别处示出)和第二钳口5802。在各种实施例中,第二钳口5802可包括仓体5850和可释放地固定到仓体5850和/或第二钳口5802的材料层5858。在各种实施例中,仓体5850和可释放地固定到其上的材料层5858可例如构成紧固件仓组件。材料层5858可包括例如支撑材料片和/或组织厚度补偿件。在某些实施例中,材料层5858可为例如可释放地固定到仓体5850的支撑材料片。第二钳口5802可具有近侧部分5804和远侧部分5806。在各种实施例中,第二钳口5802可具有位于近侧部分5804处的类似于近侧连接器5780a的近侧连接器(图77)和位于远侧部分5406处的类似于远侧连接器5880b的远侧连接器(图77)。近侧连接器和远侧连接器可相对于仓体5850固定材料层5858。
主要参见图78,仓体5850可包括平台5852。狭槽5856可例如从第二钳口5802的近侧部分5804朝远侧部分5806延伸,并且可被限定在例如平台5852的一部分中。在各种实施例中,紧固件腔5854可被限定在平台5852中。第二钳口5802还可包括可移除地定位在紧固件腔5854中的紧固件,诸如外科缝合器。举例来说,紧固件能够以可射出的方式定位在仓体5850的每个紧固件腔5854中。在各种实施例中,紧固件可在击发行程期间通过类似于滑动件5434的滑动件从仓体5850中其相应的紧固件腔5854射出(图65和图66)。
击发组件,诸如击发组件5430(图65和图66)可在击发行程期间沿着仓体5850中的狭槽5856运动。击发组件5430可包括例如击发杆5432、切割刃5436和支脚5438。在各种实施例中,击发组件5430可接合仓体5850中的滑动件,并且可在击发行程期间驱动滑动件至少部分地穿过仓体5850。在某些实施例中,滑动件可具有能够在击发行程期间接合紧固件腔5854中的驱动器的凸轮表面或斜坡。当斜坡接合紧固件腔5854中的驱动器时,斜坡可使驱动器和对应的紧固件朝向仓平台5852进行凸轮运动,并且可使紧固件从例如紧固件腔5854射出。在各种实施例中,切割刃5436可在击发行程期间切割近侧连接器和远侧连接器。切割刃5436可例如在击发行程开始时和/或开始一会儿后切割近侧连接器,并且可例如在击发行程结束时或将要结束时切割远侧连接器。
仍参见图78至图80,仓体5850可包括至少一个凹口5848,其可被限定在平台5852中(图78)。凹口5848可例如被定位在近侧连接器与远侧连接器之间。另外,在各种实施例中,材料层5858可包括一对安装件5860a,5860b。该对安装件5860a,5860b可例如与材料层5858一体成型。在某些实施例中,当材料层5858被固定到平台5852时,该对安装件5860a,5860b可从材料层5858延伸到仓体5850的凹口5848中。该对安装件5860a,5860b可定位在凹口5848中,以相对于仓体5850的平台5852保持材料层5858。在各种实施例中,当材料层5858定位在仓体5850上时,该对安装件5860a,5860b的尺寸可设定成配合在凹口5848中。此外,当将材料层5858从仓体5850提起和/或剥离时,该对安装件5860a,5860b的尺寸可设定成用于从凹口5848非强制移除。在某些实施例中,当该对安装件5860a,5860b定位在凹口5848内时,每个安装件5860a,5860b与凹口5848之间可存在空隙或间隙。空隙可例如为大约0.12mm。在某些实施例中,空隙可例如最多至大约0.24mm。在一些实施例中,例如在每个安装件5860a,5860b与凹口5848之间可存在大约0.01mm至大约0.18mm的过盈,使得每个安装件5860a,5860b例如在定位于凹口5848中时被压缩。
在各种实施例中,安装件-凹口接合可防止和/或限制材料层5858的侧向移位和/或屈曲。例如,当切割刃5436(图65和图66)切割材料层5858时,该对安装件5860a,5860b可保持定位在凹口5848中,以相对于仓平台5852将材料层5858保持在适当位置。材料层5858相对于仓体5850的移位可由限定在每个安装件5860a,5860b与凹口5848之间的空隙限制。例如,材料层5858的一些移位可能是由于空隙造成的。在各种实施例中,安装件5860a,5860b可不抵抗远离仓体5850提起和/或剥离材料层5858。例如,安装件5860a,5860b可不摩擦配合在凹口5848中,并且当将材料层远离仓体5850的平台提起时,例如在切割刃5436切割近侧连接器和远侧连接器之后,安装件5860a,5860b可容易且平滑地从凹口5848移除。
主要参见图78,凹口5848可从仓体5850中的狭槽5856延伸,并且可例如与狭槽5856相交。在此类实施例中,当该对安装件5860a,5860b延伸到凹口5848中时,例如安装件5860a可定位在狭槽5856的第一侧上,并且安装件5860b可定位在狭槽5856的第二侧上。在某些实施例中,安装件5860b可为例如安装件5860a跨过狭槽5856的镜像反射。另外,主要参见图79,该对安装件5860a,5860b可例如不与狭槽5856重叠。在此类实施例中,击发组件5430的切割刃5436(图65和图66)可例如在击发行程期间切断材料层5858,而不切割安装件5860a,5860b。换句话讲,击发组件5430可在击发行程期间在该对安装件5860a,5860b之间穿过。在此类实施例中,狭槽5856的两侧上的安装件-凹口接合可例如进一步防止和/或限制材料层5858的两个纵向侧的侧向移位和/或屈曲。主要参见图78,仓体5850可包括沿着仓体5850的长度的一部分间隔的多个凹口5848。另外,材料层5858可包括多对安装件5860a,5860b。当将材料层5858固定到仓体5850时,材料层5758的该对安装件5860a,5860b可例如与凹口5748对准。在此类实施例中,沿着较低钳口5802的长度的一部分的安装件-凹口接合可进一步防止和/或限制一定长度的材料层5858的侧向移位和/或屈曲。
现在参见图80A和图80B,与端部执行器一起使用的材料层5958可具有限定材料层5958的边缘的周边5970。在各种实施例中,材料层5958可为例如支撑材料片和/或组织厚度补偿件。另外,周边5970可包括轮廓5974和凹陷5972。在各种实施例中,凹陷5972可定位在每个轮廓5974中间,以沿着周边5970的至少一部分形成圆齿状边缘。在各种实施例中,周边可为圆齿状周边。在某些实施例中,周边5970的一部分可为圆齿状周边,并且周边的一部分还可为非圆齿状周边。在材料层5958相对于手术部位定位时,周边5970的圆齿状边缘可防止和/或限制对接触周边5970的组织的擦伤和/或其他损伤。
仍参见图80A和图80B,材料层5958可包括顶部表面5962(图80A)和底部表面5966(图80B)。顶部表面5962可例如相对于端部执行器的第一钳口或砧座定位,并且底部表面5966可例如相对于端部执行器的第二钳口或紧固件仓定位。在各种实施例中,材料层5958可包括近侧部分5904和远侧部分5906。在某些实施例中,材料层5958可包括从其顶部表面5962和/或底部表面5966延伸的安装件5960,5964。在各种实施例中,安装件5960,5964可定位在端部执行器5902中的凹陷或凹口中,诸如仓体和/或砧座中的凹口。在某些实施例中,安装件5960,5964可支撑、加强和/或硬化材料层5958。例如,当切割刃5436(图65和图66)在击发行程期间横穿材料层5958时,安装件5960可防止和/或限制材料层5958相对于仓体的移位和/或屈曲。另外,安装件5960,5964中的一个可例如接合夹紧在端部执行器5902的第一钳口与第二钳口之间的组织。在此类实施例中,安装件5960,5964可例如防止和/或限制夹紧组织相对于仓体的移位。主要参见图80A,安装件5960可位于材料层5958的远侧部分5906处。安装件5960可包括例如从顶部表面5962延伸的多个突出部或按钮。在各种实施例中,安装件5960的按钮可例如以三角形布置。主要参见图80B,安装件5964可例如从材料层5958的底部表面5966延伸。安装件5964可在材料层5958的远侧部分5906处,并且可为例如V形形状。
现在参见图81至图84,端部执行器组件5000可包括第一钳口(在别处示出)和第二钳口5002。在各种实施例中,第二钳口5002可包括紧固件仓组件,该紧固件仓组件包括紧固件仓体5050和可释放地固定到紧固件仓体5050的材料层5058。在各种实施例中,材料层5058可包括组织厚度补偿件和/或支撑材料片。例如,材料层5058可为可释放地固定到紧固件仓体5050的支撑材料片。主要参见图81,紧固件仓体5050可具有限定在其中的紧固件腔5054。另外,第二钳口5002和/或紧固件仓体5050可例如包括紧固件(诸如外科钉),所述紧固件可以可移除地定位在紧固件腔5054中。例如,紧固件能够以可射出的方式定位在仓体5050的每个紧固件腔5054中。在某些实施例中,仓体5050可包括狭槽5056,该狭槽可从第二钳口5002的近侧部分5004朝远侧部分5006延伸。在各种实施例中,击发组件5030可沿着仓体5050的狭槽5056平移。例如,击发组件5030可在击发行程期间在狭槽5056内平移,并可在击发行程期间将紧固件从紧固件腔5054射出。
仍参见图81至图84,击发组件5030可包括击发杆、切割刃5036(图81和图82)、横杆5038(图81和图82)、前缘5040(图81)和支脚5034。在击发组件5030在击发行程期间被击发穿过第二钳口5002时,切割刃5036可切割组织并且/或者切割材料层5058。例如,横杆5038可接合第一钳口,诸如其砧座中的狭槽,以相对于仓体5050保持第一钳口,并且支脚5034可接合第二钳口5002,诸如仓体5050中的狭槽5056(图81),以相对于仓体5050保持击发组件5030。在各种实施例中,击发组件5030可在击发行程期间接合仓体5050中的滑动件。击发组件5030的元件,诸如前缘5040例如可接合滑动件,并且在击发行程期间将滑动件朝远侧推动以例如将紧固件从紧固件腔5054射出。
主要参见图81,材料层5058可通过至少一个连接器可释放地固定到仓体5050。在某些实施例中,多个连接器可将材料层5058固定到仓体5050。例如,近侧连接器可在第二钳口5002的近侧部分5004处将材料层5058固定到仓体5050,并且远侧连接器5080可在第二钳口5002的远侧部分5006处将材料层5058固定到仓体5050。在各种实施例中,安装件5064可在第二钳口5002的远侧部分处从材料层5058延伸。远侧连接器5080可围绕第二钳口5002和/或仓体5050以及安装件5064的至少一部分延伸或缠绕,以例如相对于仓体5050保持材料层5058。在某些实施例中,可使用另外的连接器将材料层5058固定到仓体5050。在此类实施例中,另外的连接器可沿仓体5050的长度的至少一部分间隔,并可例如定位在近侧连接器与远侧连接器5080之间。在各种实施例中,连接器可为带、系结和/或缝合线,并且可包括例如编织的和/或缠绕的纤维。切割和/或切断连接器的端部例如可为锋利的,并且在外科医生从患者组织移除端部执行器组件时可刺穿和/或撕裂相邻组织。然而,编织的连接器的端部比非编织的连接器的端部较不锋利。例如,编织的连接器的切割端部可磨损,这可产生较不锋利的端部。利用编织的连接器,通过连接器的切割和/或切断端部可减少和/或基本上消除对组织的刺穿和/或撕裂。在各种实施例中,编织的连接器可例如具有与非编织的连接器至少基本上相同的拉伸保持强度。另外,在某些实施例中,例如,当编织的连接器被切割和/或切断时,其可具有比非编织的连接器显著更小的压缩强度。
仍主要参见图81,远侧连接器5080可相对于仓体5050保持材料层5058。当远侧连接器5080以及任何另外的连接器断裂、被切割、移位、或以其他方式被克服时,材料层5058可从仓体5050被释放。在某些实施例中,在击发组件5030在击发行程期间沿紧固件仓5050中的狭槽5056平移时,击发组件5030可克服远侧连接器5080。例如,在击发行程期间,击发组件5030可切割夹紧在第一钳口与第二钳口5002之间的组织,并且还可使紧固件从紧固件腔5054运动到被夹紧的组织和材料层5058中。在各种实施例中,击发组件5030可在击发行程期间朝远侧推动滑动件。滑动件可具有例如能够接合紧固件腔5054中的驱动器的凸轮表面或斜坡。当斜坡接合驱动器时,斜坡可将驱动器朝材料层5058推动,以使紧固件从紧固件腔5054射出。另外,击发组件5030可在击发行程期间切割材料层5058和/或远侧连接器5080。
仍参见图81至图84,在各种实施例中,第二钳口5002可在击发行程开始时和/或开始一会儿后克服一个或多个连接器诸如或包括远侧连接器5080。换句话讲,第二钳口5002的元件可在击发行程开始时和/或开始一会儿后克服远侧连接器5080。第二钳口5002和/或紧固件仓组件可包括例如致动器5010,该致动器可在紧固件从紧固件腔5054射出之前克服远侧连接器5080。致动器5010可克服远侧连接器5080,并且材料层5058可从仓体5050释放,即便击发行程过早终止,也就是说,在击发组件5030到达第二钳口5002的远侧部分5006之前。在各种实施例中,致动器5010可包括底侧5016、侧壁5018和/或边缘5026。侧壁5018可从底侧5016延伸,并围绕仓体5050的至少一部分延伸。边缘5026可从侧壁5018延伸,并围绕仓体5050的至少一部分延伸。在各种实施例中,边缘5026可例如延伸到仓体5050中的狭缝5052中。底侧5016、侧壁5018和/或边缘5026可延伸经过仓体5050和定位在其紧固件腔5054中的紧固件,并且/或者围绕仓体5050和定位在其紧固件腔5054中的紧固件延伸。另外,致动器5010可相对于仓体5050被可运动地保持。例如,致动器5010可从预致动位置(图81)运动到致动位置(图82)。在某些实施例中,当致动器5010相对于仓体5050运动时,致动器5010的边缘5026可在仓体5050中的狭缝5052中滑动。当致动器5010在相对于仓体5050运动时,致动器5010可相对于定位在仓体5050的紧固件腔5054中的紧固件滑动。例如,致动器5010可滑过定位于仓体5050中的紧固件,以及/或者围绕其滑动。
主要参见图81至图84,致动器5010可包括狭槽5012,当致动器5010相对于仓体5050定位时,该狭槽可从第二钳口5002的近侧部分5004朝远侧部分5006延伸。致动器5010中的狭槽5012可例如与仓体5050中的狭槽5056(图81)对应和/或对准。另外,在击发组件5030在击发行程期间在仓体5050中的狭槽5056内平移时,击发组件5030可在致动器5010中的狭槽5012内平移。在各种实施例中,击发组件5030可接合致动器5010,以便当击发组件5030处于击发行程一开始时或开始一会儿后使致动器5010朝远侧运动。在此类实施例中,击发组件5030可在第二钳口5002的近侧部分5004处致动致动器5010。举例来说,当致动器5010被致动并朝远侧运动时,致动器5010的远侧端部可切割远侧连接器5080,或以其他方式克服远侧连接器5080。换句话讲,致动器5010朝近侧致动可实现材料层5058从仓体5050朝远侧释放。在各种实施例中,致动器5010仅可朝远侧移位以克服远侧连接器5080。在至少一个实施例中,致动器5010可移位大约1.0mm,然后克服远侧连接器5080。在某些实施例中,致动器5010可移位大约0.5mm至大约5.0mm,然后克服远侧连接器5180。
主要参见图81和图82,当击发组件5030在一段击发行程期间在非击发位置与部分击发位置之间运动时,致动器5010可从预致动位置(图81)向致动位置(图82)运动。在各种实施例中,致动器5010中的狭槽5012可包括释放止挡件5014。例如,释放止挡件5014可包括跨过狭槽5012的脆弱桥接件。主要参见图82,击发组件5030的元件可在击发组件5030在击发行程期间沿着狭槽5056(图81)平移时推压释放止挡件5014。例如在击发行程开始时和/或开始一会儿后,击发组件5030可推压释放止挡件5014。在某些实施例中,释放止挡件5014可位于狭槽5012的近侧端部附近,并且击发组件5030的元件,诸如前缘5040,在击发行程一开始便可邻接释放止挡件5014。当前缘5040定位成抵靠释放止挡件5014时,前缘5040可推压致动器5010并且使致动器5010朝远侧运动。在某些实施例中,主要参见图85B,致动器5010可例如朝远侧运动,直到其接触硬止挡件5060。硬止挡件5060可例如位于第二钳口5002的远侧部分5006处,并且可防止致动器5010进一步朝远侧运动。在各种实施例中,致动器5010可在击发组件5030将紧固件从紧固件腔5054射出之前邻接硬止挡件5060。在某些实施例中,在击发组件5030从紧固件腔5054射出至少一个紧固件时,并且/或者在击发组件5030从紧固件腔5054射出至少一个紧固件后,致动器可邻接硬止挡件5060。
仍参见图82,当致动器5010被击发组件5030朝远侧推动时,致动器5010可切割远侧连接器5080,或以其他方式克服远侧连接器5080,以在第二钳口5002的远侧部分5006处从仓体5050释放材料层5058。在某些实施例中,致动器5010可包括凹口5024以用于接收并保持远侧连接器5080。在致动器5010朝远侧向硬止挡件5060移位时,凹口5024可保持远侧连接器5080。另外,致动器5010可例如包括沿着凹口5024的一部分的切割刃5020。在某些实施例中,当致动器5010朝硬止挡件5060运动时,可在硬止挡件5060与致动器5010的切割刃5020之间推动远侧连接器5080。在各种实施例中,当切割刃5020被推入硬止挡件5060中时,切割刃5020可切割远侧连接器5080。在此类实施例中,远侧连接器5080可在击发行程开始时和/或开始一会儿后,并且在紧固件从紧固件腔5054击发之前被致动器5010的切割刃5020切割。在各种实施例中,致动器5010能够在不切割远侧连接器5080的情况下克服远侧连接器5080。例如,致动器5010可迫使远侧连接器5080离开适当位置或可将远侧连接器5080拉离适当位置,使得远侧连接器5080不再相对于仓体5050保持材料层5058。在各种实施例中,致动器5010的远侧运动可克服约束件或解锁,诸如凸轮锁,其将远侧连接器5080锁定或/绷紧在材料层5058周围。例如,参见图30,约束件694可被定位在较低钳口680中,并且例如可被定位在盘680a与仓体682之间。在各种实施例中,当组装端部执行器时,可使用约束件694,并且可将连接器S3连接到其上。当约束件694被推动并固定就位时,约束件694可围绕层B2绷紧连接器S3,并且能够可调整地定位以调整连接器S3围绕层B2的紧密度。在各种实施例中,再次参见图82,致动器5010可例如解锁约束件,诸如约束件694(图30)。致动器5010可使约束件进行凸轮运动,使得约束件松开和/或释放远侧连接器5080。
在各种实施例中,沿仓体5050的长度的另外的连接器可在击发行程开始时和/或开始一会儿后被致动器5010切割,或以其他方式被克服。例如,致动器5010上的近侧切割刃可切割另外的近侧连接器,并且/或者致动器5010上的中间切割刃可切割另外的中间连接器。在击发行程开始时和/或开始一会儿后,各种切割刃和/或致动器5010的部分可切割每个连接器或以其他方式克服其。除此之外或另选地,击发组件5030的切割刃5036可切割另外的连接器或以其他方式克服其。例如,击发组件5030的切割刃5036可切割第二钳口5002的近侧部分5004处的连接器,并且致动器5010的切割刃5020可在紧固件从仓体5050的紧固件腔5054射出之前切割远侧连接器5080。在某些实施例中,致动器5010可在至少一个紧固件从紧固件腔5054射出时以及/或者在至少一个紧固件从紧固件腔5054射出之后克服远侧连接器5080。
主要参见图83和图84,当致动器5010被硬止挡件5060阻挡进一步远侧运动时,击发组件5030可推动穿过致动器5010的狭槽5012中的释放止挡件5014。例如,击发组件5030的前缘5040可使释放止挡件5014的脆弱桥接件断裂,以在击发行程期间沿着狭槽5012继续朝远侧运动。脆弱桥接件可为足够刚性的以在致动器5010朝远侧向硬止挡件5060移位时承受击发组件5030的力,并且脆弱桥接件可为足够脆弱的以在致动器5010到达硬止挡件5060时断裂,而不需要电机和/或操作者施加过大的力。致动器5010和/或其脆弱桥接件可包含例如不锈钢、钛、铝、液晶聚合物(LCP)、尼龙和/或聚醚酰亚胺。在某些实施例中,致动器5010可包含不锈钢,并且脆弱桥接件可包含不锈钢薄片。在某些实施例中,脆弱桥接件可包括穿孔,该穿孔可增加其脆弱性。穿孔的尺寸和形状可被选择成使得脆弱桥接件适当易断裂。在各种实施例中,致动器5010可在紧固件从紧固件仓5050击发之前克服远侧连接器5080。在某些实施例中,在致动器5010克服远侧连接器5080时或之前,至少一个紧固件可从紧固件腔击发。在冲破释放止挡件5014时,击发组件5030可沿着仓体5050中的狭槽5056(图81)并且沿着致动器5010中的狭槽5012继续朝远侧运动,以在击发行程的剩余部分期间从紧固件仓5050射出紧固件。换句话讲,击发组件5030可在击发行程的第一阶段或部分期间致动致动器,并且可从紧固件腔5054击发紧固件,以及/或者在击发行程的第二阶段或部分期间切割组织和/或材料层5058。
现在参见图85和图86,端部执行器组件可包括第一钳口5102和在别处示出的第二钳口。在各种实施例中,第一钳口5102可包括砧座框架5170和可释放地固定到砧座框架5170的材料层。材料层可包括例如组织厚度补偿件和/或支撑材料片,类似于材料层5058(图81-84)。例如,材料层可为可释放地固定到砧座框架5170的支撑材料片。在某些实施例中,砧座框架5170可包括狭槽5172,该狭槽可从第一钳口5102的近侧部分5104朝远侧部分5106延伸。在各种实施例中,击发组件5130可沿着砧座框架5170的狭槽5172平移。在各种实施例中,击发组件5130可在击发行程期间沿着狭槽5172平移。击发组件5130沿着狭槽5172的平移可对应于击发元件穿过端部执行器组件的第二钳口的平移。在击发元件平移穿过例如第二钳口时,击发元件可将紧固件从第二钳口射出进入到夹紧在第一钳口5102与第二钳口之间的材料层和组织中。主要参见图85,击发组件5130可包括击发杆5132和前缘5136。在各种实施例中,击发组件5130的前缘5136可包括用于切割夹紧在第一钳口5102与第二钳口之间的组织和材料层的切割刃。
主要参见图85,材料层可通过至少一个连接器可释放地固定到砧座框架5170。在某些实施例中,多个连接器可将材料层固定到砧座框架5170。例如,近侧连接器可在第一钳口5102的近侧部分5104处将材料层固定到砧座框架5170,并且远侧连接器5180可在第一钳口5102的远侧部分5106处将材料层固定到砧座框架5170。在某些实施例中,另外的连接器可将材料层固定到砧座框架5170。在此类实施例中,另外的连接器可沿砧座框架5170的长度的至少一部分间隔,并可例如定位在近侧连接器与远侧连接器5180之间。
仍主要参见图85,远侧连接器5180可相对于砧座框架5170保持材料层。当远侧连接器5180和任何另外的连接器断裂、被切割、移位、或以其他方式被克服时,材料层可从砧座框架5170被释放。在某些实施例中,在击发组件5130在击发行程期间沿砧座框架5170中的狭槽5172平移时,击发组件5130可克服远侧连接器5180。在各种实施例中,第一钳口5102的元件可在击发行程开始时和/或开始一会儿后克服一个或多个连接器诸如或包括远侧连接器5180。换句话讲,在击发行程开始时和/或开始一会儿后,以及在紧固件被射入夹紧组织之前,第一钳口5102可克服远侧连接器5180。在各种实施例中,第一钳口5102可包括例如致动器5110,该致动器可在击发行程开始时和/或开始一会儿后克服远侧连接器5080。致动器5110可克服远侧连接器5180,并且材料层5158可从砧座框架5170被释放,即便击发行程过早终止,也就是说,在击发组件5130到达第一钳口5102的远侧部分5106之前。在各种实施例中,致动器5110可包括沿着砧座框架5170的长度延伸的纵向板。在某些实施例中,该板可包括在砧座狭槽5172的一侧上的纵向部分,在砧座狭槽5172的另一侧上的另一个纵向部分,以及在纵向部分之间延伸以加强致动器5110的远侧端部的远侧桥接件5174。致动器5110可延伸穿过第一钳口5102,并且可定位在例如第一钳口5102的紧固件成形表面与外表面之间。另外,致动器5110可相对于砧座框架5170可运动地保持。例如,致动器5110可从预致动位置(图85)运动到致动位置(图86)。
主要参见图85,致动器5110可包括狭槽5112,当致动器5110相对于砧座框架5170定位时,该狭槽可从第一钳口5102的近侧部分5104朝向远侧部分5106延伸。致动器5110中的狭槽5112可例如与砧座框架5170中的狭槽5172对应和/或对准。另外,在击发组件5130在击发行程期间沿着砧座框架5170中的狭槽5172平移时,击发组件5130可沿着致动器5110中的狭槽5112平移。在各种实施例中,击发组件5130可接合致动器5110,以在击发组件5130处于击发行程开始或开始一会儿后时使致动器5110朝远侧运动。在此类实施例中,击发组件5130可在第一钳口5102的近侧部分5104处致动致动器5110。例如,当致动器5110被致动并朝远侧运动时,其远侧端部可切割远侧连接器5180,或以其他方式克服远侧连接器5180。换句话讲,致动器5110的近侧致动可实现材料层从砧座框架5172朝远侧释放。在各种实施例中,致动器5110仅可朝远侧移位,以克服远侧连接器5180。在至少一个实施例中,致动器5110可在克服远侧连接器5180之前移位大约1.0mm。在某些实施例中,致动器5110可在克服远侧连接器5180之前移位大约0.5mm至大约5.0mm。
仍参见图85和图86,当击发组件5130在一段击发行程期间在非击发位置与部分击发位置之间运动时,致动器5110可从预致动位置(图85)运动到致动位置(图86)。在各种实施例中,致动器5110中的狭槽5112可包括释放止挡件5114。释放止挡件5114可具有例如比狭槽5112的与释放止挡件5114相邻的部分更窄的宽度。主要参见图85,击发组件5130的元件可在击发组件5130在击发行程期间沿着狭槽5172平移时推压释放止挡件5114。例如在击发行程开始时和/或开始一会儿后,击发组件5130可推压释放止挡件5114。在某些实施例中,释放止挡件5114可位于狭槽5112的近侧端部附近,并且击发组件5130的元件,诸如前缘5136,在击发行程一开始时便可邻接释放止挡件5114。当前缘5136定位成抵靠释放止挡件5114时,前缘5136可推压致动器5110并且使致动器5110朝远侧运动。在某些实施例中,致动器5110可例如朝远侧运动,直到其接触硬止挡件5160。硬止挡件5160可在第一钳口5102和/或砧座框架5170的远侧部分5106处,并且例如可防止致动器5110进一步朝远侧运动。
主要参见图86,当致动器5110被击发组件5130朝远侧推动时,致动器5110可切割远侧连接器5180,或以其他方式克服远侧连接器5180,以在第一钳口5102的远侧部分5106处从砧座框架5172释放材料层。在某些实施例中,致动器5110可包括凹口5124,以用于接收和保持远侧连接器5180。当致动器5110朝远侧向硬止挡件5160移位时,凹口5124可保持远侧连接器5180。另外,致动器5110可例如包括沿着凹口5124的切割刃5120。在某些实施例中,当致动器5110朝硬止挡件5160运动时,可在硬止挡件5160与致动器5110的切割刃5120之间推动远侧连接器5180。在各种实施例中,当切割刃5120被推入硬止挡件5160中时,切割刃5120可切割远侧连接器5180。在此类实施例中,远侧连接器5080可在击发行程开始时和/或开始一会儿后被致动器5110的切割刃5120切割。在各种实施例中,致动器5110能够在不切割远侧连接器5180的情况下克服远侧连接器5080。例如,致动器5110可迫使远侧连接器5180离开适当位置或可将远侧连接器5180拉离适当位置,使得远侧连接器5180不再相对于砧座框架5170保持材料层。
在各种实施例中,沿砧座框架5170的长度的另外的连接器可在击发行程开始时和/或开始一会儿后被致动器5110切割,或以其他方式被克服。例如,致动器5110上的近侧切割刃可切割另外的近侧连接器,并且/或者致动器5110上的中间切割刃可切割另外的中间连接器。在击发行程开始时和/或开始一会儿后,各种切割刃和/或致动器5110的部分可切割每个连接器或以其他方式克服其。除此之外或另选地,击发组件5130的切割刃可切割另外的连接器或以其他方式克服其。例如,击发组件切割刃可切割第一钳口5102的近侧部分5104处的连接器,并且致动器5110的切割刃5120可在紧固件从第二钳口的仓体射出之前切割远侧连接器5180。在某些实施例中,致动器5110可在至少一个紧固件从紧固件腔的射出时,以及/或者在至少一个紧固件已从紧固件腔的射出之后克服远侧连接器5180。当致动器5110被硬止挡件5160阻挡进一步远侧运动时,击发组件5130可推动穿过致动器5110的狭槽5112中的释放止挡件5114。当击发组件5130推动穿过释放止挡件5114时,击发组件5130可加宽狭槽5112的宽度,以允许击发组件5130穿过其中。例如,击发组件5130的前缘5136可加宽释放止挡件5114,使得击发杆5132可延伸穿过释放止挡件5114并且沿着狭槽5112平移。在各种实施例中,释放止挡件5114可为足够刚性的,以在致动器5110朝远侧向硬止挡件5160移位时承受击发组件5130的力,并且释放止挡件5114可为足够柔性的,以在致动器5110到达硬止挡件5160时加宽,而不需要电机和/或操作者施加过大的力。致动器5110和/或其释放止挡件5114可包含例如不锈钢、钛、铝、液晶聚合物(LCP)、尼龙和/或聚醚酰亚胺。在各种实施例中,致动器5110可在紧固件从第二钳口的紧固件仓击发之前克服远侧连接器5180。在某些实施例中,远侧连接器5180可在至少一个紧固件从紧固件腔的射出之后和/或与此同时被克服。在延伸穿过释放止挡件5114时,击发组件5130可沿着砧座框架5172中的狭槽5172并且沿着致动器5110中的狭槽5112继续朝远侧运动。
在各种实施例中,当致动器被击发组件致动时,其可朝近侧移位。近侧移位致动器可例如克服近侧连接器。在某些实施例中,致动器的第一片可在致动时朝远侧移位,并且致动器的第二片可在致动时朝近侧移位。致动器的第一片和致动器的第二片可同时克服连接器。例如,在致动器的第二片克服远侧连接器时,致动器的第一片可克服近侧连接器。
在各种实施例中,端部执行器组件可包括第一钳口和第二钳口。在某些实施例中,一个材料层能够可释放地固定到第一钳口,并且另一材料层能够可释放地固定到第二钳口。例如,第一材料层能够可释放地固定到第一钳口和/或砧座框架,并且第二材料层能够可释放地固定到第二钳口和/或紧固件仓组件。在某些实施例中,致动器诸如致动器5010例如可从第一钳口释放第一材料层,并且第二致动器诸如致动器5110例如可从第二钳口释放第二材料层。由第一致动器释放第一材料层并且由第二致动器释放第二材料层可被定时。例如,致动器可被布置和/或被构造成能够使得第一材料层和第二材料层可从端部执行器组件同时以及/或者顺序地释放。
总体参见图87至图90,外科缝合器械的端部执行器可包括第一钳口和第二钳口,其中第一钳口和第二钳口中的至少一者被构造成能够相对于另一者运动。端部执行器可包括具有钉仓通道的第一钳口和具有砧座的第二钳口,所述砧座诸如砧座2030(图88A),其可包括多个成形凹坑2032(图88A),其中砧座2030可朝向和/或远离钉仓通道枢转。钉仓通道被构造成能够接收钉仓2010(图87),该钉仓能够可移除地保持在钉仓通道内。当砧座2030朝向钉仓通道枢转时,组织T可例如捕获在砧座2030与钉仓2010之间。
主要参见图87,钉仓组件,诸如钉仓组件2000可包括例如组织厚度补偿件诸如组织厚度补偿件2020和钉仓诸如钉仓2010,该钉仓可包括仓体2012和多级仓平台2014。如图87所示,仓平台2014可包括纵向延伸穿过其中的狭槽2016,其中狭槽2016被构造成能够接收切割构件,该切割构件能够可滑动地运动穿过狭槽2016。
进一步地,如图87所示,仓平台2014可包括沿着狭槽2016纵向延伸的多个表面2018a-c,其中表面2018a可比表面2018b更靠近狭槽2016,表面2018b可比表面2018c更靠近狭槽2016。例如,表面2018b可沿远离狭槽2016的方向与表面2018a侧向偏置,并且表面2018c也可沿远离狭槽2016的方向与表面2018b侧向偏置。此外,表面2018a-c可彼此竖直偏置。例如,表面2018a-c可各自位于或至少基本上位于单独平面中,其中表面2018a-c的平面可彼此竖直偏置。
进一步地,再次参见图87至图88B,仓2010可包括仓体2012内的多个钉腔2022,其中腔2022可包括仓平台2014的表面2018a-c中的开口。钉可被定位在每个钉腔2022中。例如,钉2024a-c可定位在腔2022中,并且可由钉驱动器2026a-c支撑在仓体2012内。滑动件和/或击发构件例如可被推进穿过钉仓2010,以将钉腔2022内的钉驱动器2026a-c向上提起,并且通过表面2018a-c中的开口从腔2022分别射出钉2024a-c。在砧座2030处于闭合位置中时,钉2024a-c可通过抵靠限定在砧座2030中的对应成形凹坑2032推进钉2024a-c来形成。
如图88A所示,当砧座2030处于闭合位置中时,驱动器2026a-c可被定位在距限定在砧座2030中的对应成形凹坑2032不同的非击发距离处。例如,如图88A所示,驱动器2026a可定位在距其对应成形凹坑2032第一非击发距离处,驱动器2026b可定位在距其对应成形凹坑2032第二非击发距离处,并且驱动器2026c可定位在距其对应成形凹坑2032第三非击发距离处,其中例如第一距离可短于第二距离,并且其中第二距离可短于第三距离。现在参见图88B,钉驱动器2026a可驱动支撑在其上的钉2024a至第一成形高度2021a;钉驱动器2026b可驱动支撑在其上的钉2024b至第二成形高度2021b,并且钉驱动器2026c可驱动支撑在其上的钉2024c至第三成形高度2021c,其中例如第一成形高度2021a可短于第二成形高度2021b,并且第二成形高度2021b可短于第三成形高度2021c。钉2024a-c可包括相同的或基本上相同的未成形或非击发高度。另选地,驱动器2026a-c可支撑具有不同未成形高度的钉。此外,如图88A所示,未成形钉2024a-c的顶端在处于非击发位置时可位于或至少基本上位于不同的平面中。另选地,钉仓2010可包括具有钉顶端的未成形钉,所述钉顶端可位于或至少基本上位于单个平面中。设想了其他实施例,其中钉2024a-c可成形为任何合适的成形高度和/或任何相对的成形高度。
再次参见图87至图88B,组织厚度补偿件2020可包括多个部分,诸如部分2020a-c(参见图87),所述部分可分别由钉2024a-c捕获。如图88A所示,部分2020a-c可彼此侧向偏置。例如,部分2020b可沿远离狭槽2016的方向与部分2020a侧向偏置,并且部分2020c也可沿远离狭槽2016的方向与部分2020b侧向偏置。此外,如图88A所示,部分2020a-c可包括平台接触表面2036a-c,其中补偿件2020可定位成抵靠仓平台2014,使得平台接触表面2036a-c能够分别可移除地定位成抵靠或邻近平台2014的表面2018a-c。类似于表面2018a-c,平台接触表面2036a-c可彼此竖直地偏置。例如,如图88A所示,表面2036a-c可各自位于或至少基本上位于单独平面中,其中表面2036a-c的平面可彼此竖直偏置。换句话讲,表面2036a可位于第一平面中,表面2036b可位于第二平面中,并且表面2036c可位于第三平面中,其中第一平面比第二平面距基准面更近,并且第二平面比第三平面距基准面更近,所述基准面诸如砧座2030处的基准面2031。如图88A所示,基准面2031可包括在砧座2030处于闭合位置时穿过砧座2030的平面,其中基准面2031可与表面2036a-c平行或基本上平行。
进一步地,如图88A所示,表面2036a和2036b的平面之间的距离可与表面2036b和2036c的平面之间的距离相同或至少基本上相同。另选地,表面2036a和2036b的平面之间的距离可与表面2036b和2036c的平面之间的距离不同。例如,表面2036a和2036b的平面之间的距离可小于表面2036b和2036c的平面之间的距离。
再次参见图87至图88B,部分2020a-c可包括组织接触表面2034a-c,其可定位成抵靠或邻近组织T。类似于表面2018a-c,如图88A所示,组织接触表面2034a-c可彼此竖直偏置。例如,如图88A所示,表面2034a-c可各自位于或至少基本上位于单独平面中,其中表面2034a-c的平面可彼此竖直偏置。换句话讲,表面2034a可位于第一平面中,表面2034b可位于第二平面中,并且表面2034c可位于第三平面中,其中第一平面比第二平面距基准面更近,并且第二平面比第三平面距基准面2031更近,其中基准面2031可与表面2036a-c平行或基本上平行。
进一步地,表面2034a和2034b的平面之间的距离可与表面2034b和2034c的平面之间的距离相同或至少基本上相同。另选地,表面2034a和2034b的平面之间的距离可与表面2034b和2034c的平面之间的距离不同。例如,表面2034a和2034b的平面之间的距离可小于表面2034b和2034c的平面之间的距离。
参见图88至图90,补偿件2020的部分2020a-c可包括均匀或基本上均匀的未压缩厚度。例如,如图88中的剖视图所示,部分2020a可包括表面2034a与表面2036a之间的第一未压缩厚度,并且部分2020b可包括表面2034b与表面2036b之间的第二未压缩厚度,其中第一未压缩厚度可与第二未压缩厚度相同或基本上相同。此外,部分2020c可包括表面2034c与2036c之间的第三未压缩厚度,其中第三未压缩厚度可与第一未压缩厚度和/或第二未压缩厚度相同或基本上相同。
另选地,补偿件2020可包括具有不同未压缩厚度的部分,其中部分2020a-c中的全部或一些可包括不同未压缩厚度。例如,如图89所示,部分2020c的第三未压缩厚度可大于部分2020a的第二未压缩厚度,而部分2020a的第一未压缩厚度可包括与部分2020b的第二未压缩厚度相同或基本上相同的未压缩厚度。在某些情况下,第二未压缩厚度可大于第一未压缩厚度,并且第三未压缩厚度可大于第二未压缩厚度,从而形成厚度梯度。因此,补偿件2020可具有厚度梯度,其中补偿件2020的某些部分的未压缩厚度可取决于这些部分的相对位置。例如,补偿件2020可包括具有最小未压缩厚度的中心部分、具有最大未压缩厚度的周边部分、以及具有中等未压缩厚度的中间部分。另选地,中心部分可具有最大未压缩厚度,并且周边部分可具有最小未压缩厚度。读者将会理解,部分2020a-c的厚度及其在补偿件2020内的相对位置被构造成能够为成形钉2024a-c内的组织T提供所需厚度补偿。
进一步地,如图88B所示,成形钉2024a-c可捕获组织T和/或补偿件2020,其中所捕获的组织T和所捕获的补偿件2020可竞争成形钉2024a-c内的空间。因此,组织T和/或补偿件2020可在由成形钉2024a-c施加到其上的压缩力下被压缩,该压缩力可至少部分地取决于钉2024a-c的成形高度、组织T的可压缩性、补偿件2020的可压缩性、组织T厚度,和/或补偿件2020厚度。因此,这些参数中的一些或全部可被操纵,以在成形钉2024a-c内的组织T中产生所需压缩。
进一步地,组织T的可压缩性可至少部分地取决于组织T的弹性模量,并且补偿件2020的可压缩性可至少部分地取决于补偿件2020的弹性模量,其中较大弹性模量可产生较大可压缩性。例如,如图88B所示,钉2024a可捕获补偿件2020的对应部分2020a以及对应你组织T,这可导致部分2020a和对应组织T在成形钉2024a内对空间的竞争。在图88B中示出的实例中,组织T可具有比对应部分2020a更大的弹性模量。因此,成形钉2024a可将组织T压缩至比对应部分2020a更大的程度。此外,如上所述并且如图88B所示,钉2024a的成形高度2021a可短于钉2024b的成形高度2021b,并且成形高度2021b可短于钉2024c的成形高度2021c。因此,成形钉2024a内可用的空间可小于成形钉2024b内可用的空间,并且成形钉2024b内可用的空间可小于成形钉2024c内可用的空间。结果,成形钉2024a内的组织T可被压缩至比成形钉2024b内的组织T更大的程度,并且成形钉2024b内的组织T可被压缩至比成形钉2024c内的组织T更大的程度。
进一步地,补偿件2020的部分2020a-c可具有不同弹性模量,这可导致补偿件2020上的不同程度的可压缩性。例如,部分2020a可具有大于部分2020b的弹性模量,并且部分2020b可具有大于部分2020c的弹性模量。结果,补偿件2020上可存在弹性模量梯度,其中中心部分(例如,部分2020a中的一个)可具有大于周边部分(例如,部分2020c中的一个)的弹性模量。此外,中间部分(例如,部分2020b中的一个)可具有大于周边部分的弹性模量,以及小于中心部分的弹性模量。因此,成形钉2024a-c内的组织T被构造成能够通过操纵对应部分2020a-c的弹性模量来经受所需压缩力。
再次参见图88B,如上所述,组织T和补偿件2020所经受的压缩力可至少部分地取决于成形钉2024a-c的高度2021a-c,该高度可确定成形钉2024a-c内可用的总空间,以用于组织T和补偿件2020的对应部分2020a-c在其中竞争。例如,如图88B所示,成形钉2024c内可用的空间可大于成形钉2024b内可用的空间,并且成形钉2024b内可用的空间可大于成形钉2024a内可用的空间。结果,组织T和对应部分2020a在钉2024a内所经受的压缩力可大于组织T和对应部分2020b在成形钉2024b内所经受的压缩力。此外,组织T和对应部分2020b在成形钉2024b内所经受的压缩力可大于组织T和对应部分2020c在成形钉2024c内所经受的压缩力。因此,可建立组织压缩梯度,其中成形钉2024a内的组织T可经受大于成形钉2024b内的组织T所经受的压缩,并且钉2024b内的组织T可经受大于钉2024c内的组织T所经受的压缩。设想了其他实施例,其中组织厚度补偿件和成形钉可被制成通过成形钉内的组织T产生合适的压缩。
进一步地,参见图89,组织厚度补偿件2020’可包括多个部分2020’a-c。在正被钉2024a-c捕获时,组织T和补偿件2020’所经受的压缩力可至少部分地取决于补偿件2020’的部分2020’a-c的厚度。部分2020’a-c可包括不同未压缩厚度。例如,如图89所示,部分2020’c可具有大于部分2020’a和2020’b的未压缩厚度,这可导致由钉2024c捕获的组织T中的压缩大于由钉2024a和2024b捕获的组织T中的压缩。在某些情况下,捕获的组织T和捕获的补偿件2020’所经受的压缩力可与补偿件2020’的厚度成正比。
现在参见图90,组织厚度补偿件复合物诸如复合物2060可包括多个组织厚度补偿件。例如,复合物2060可包括组织厚度补偿件2020和组织厚度补偿件2080,其中补偿件2080可至少部分地定位成邻近或抵靠补偿件2020。例如,补偿件2080可选择性地定位在补偿件2020的某些部分上方,以提供例如所需厚度和/或适形性。如图90所示,补偿件2080可包括部分2080c,其可定位在例如补偿件2020的部分2020c上方。
进一步地,补偿件2080和补偿件2020可例如通过粘合剂接合在一起。可在本公开的范围内设想用于将补偿件2020附接到补偿件2080的其他附接装置。类似于补偿件2020,补偿件2080的部分可包括各种厚度、弹性模量、和/或相对空间布置。此外,补偿件2080的部分和补偿件2020的对应部分可包括相同或不同的未压缩厚度和/或弹性模量。例如,部分2080c可包括高于部分2020c的弹性模量,以并且可在复合物2080的周边区域上提供适形组织接触表面。
进一步地,补偿件2020和/或补偿件2080可由生物相容性材料构成。此外,补偿件2020和/或补偿件2080可由例如可生物降解材料诸如PGA、PCL、PLLA和/或它们的组合构成。补偿件2020和补偿件2080可由相同材料或不同材料构成,以在复合物2080上产生所需局部可压缩性。
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/或被包含在钉线内。换句话讲,钉线内的某些钉可以捕获组织的较厚部分,而钉线内的其他钉可以捕获组织的较薄部分。在这种情况下,组织厚度补偿件可在钉内呈现不同高度或厚度,并将压缩力施加到被捕获在钉内的组织,而不论被捕获组织是厚还是薄。在各种实施例中,组织厚度补偿件可补偿组织刚度的变化。例如,钉线内的某些钉可捕获组织的高度压缩部分,而钉线内的其他钉可捕获组织的较低压缩部分。在这种情况下,组织厚度补偿件被构造成能够例如在已捕获具有较低可压缩性或较高刚度的组织的钉内呈现较小的高度,并且相对应地,在已捕获具有较高可压缩性或较低刚度的组织的钉内呈现较大的高度。在任何情况下,例如,无论组织厚度补偿件是否补偿组织厚度的变化和/或组织刚度的变化,其均可被称为“组织补偿件”和/或“补偿件”。
可将本文所公开的装置设计为单次使用后丢弃,或者可将它们设计为可多次使用。然而,在任一种情况下,该装置均可进行修复,以在至少一次使用后再次使用。修复可包括如下步骤的任意组合:拆卸装置、然后清洗或更换特定零件、以及重新组装。特别是,该装置可以拆卸,而且可以任意组合选择性地更换或移除该装置任意数目的特定零件或部件。清洗和/或更换特定部件后,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团队重新组装。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/更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,本文所述的发明将在手术前进行处理。首先,获取新的或用过的器械,并根据需要进行清洗。然后对器械进行灭菌。在一种灭菌技术中,将器械放置在闭合且密封的容器中,诸如塑料或TYVEK袋中。然后将容器和器械置于可穿透该容器的辐射区,诸如γ辐射、x-射线或高能电子。辐射杀灭器械上和容器中的细菌。然后将灭菌后的器械保存在无菌容器中。该密封容器使器械保持无菌,直到在医疗设施中打开该容器为止。
本文所述的各种实施例在钉的上下文中有所描述,所述钉可移除地储存在钉仓内以与外科缝合器械一起使用。在一些情况下,钉可包括线材,所述线材在接触外科缝合器的砧座时变形。此类线材可例如由金属诸如不锈钢,和/或任何其他合适的材料构成。此类实施例以及其教导内容可应用于包括紧固件的实施例,所述紧固件可移除地储存在紧固件仓内,以与任何合适的紧固器械一起使用。
本文描述的各种实施例在附接到钉仓和/或紧固件仓、以及/或者与钉仓和/或紧固件仓一起使用的组织厚度补偿件的上下文中进行描述。此类组织厚度补偿件可用于补偿从钉仓的一端到另一端的组织厚度变化,或用于补偿捕获在一个钉或紧固件内的组织厚度较之捕获在另一个钉或紧固件内的组织厚度的变化。此类组织厚度补偿件还可用于补偿从钉仓的一侧到另一侧的组织厚度变化。此类实施例及其教导内容可应用于包括附接到钉仓和/或紧固件仓、以及/或者与钉仓和/或紧固件仓一起使用的一个或多个材料层的实施例。层可包含支撑材料。
本文所述的各种实施例在线性端部执行器和/或线性紧固件仓的上下文中有所描述。此类实施例及其教导内容可应用于非线性端部执行器和/或非线性紧固件仓,诸如圆形和/或波状端部执行器。例如,各种端部执行器,包括非线性端部执行器,在提交于2011年2月28日,名称为“SURGICALSTAPLING INSTRUMENT”的美国专利申请序列号13/036,647(现为美国专利申请公布2011/0226837)中公开,该专利申请据此全文以引用方式并入。另外,提交于2012年9月29日的名称为“STAPLE CARTRIDGE”的美国专利申请序列号12/893,461(现为美国专利申请公布2012/0074198)据此全文以引用方式并入。提交于2008年2月15日的名称为“ENDEFFECTORS FOR A SURGICAL CUTTING AND STAPLINGINSTRUMENT”的美国专利申请序列号12/031,873(现为美国专利7,980,443)也据此全文以引用方式并入。
据述以引用方式全文或部分地并入本文的任何专利、公布或其他公开材料均仅在所并入的材料不与本发明所述的现有定义、陈述或其他公开材料相冲突的程度下并入本文。因此,在必要的情况下,本文明确陈述的公开内容可取代任何与之冲突的以引用方式并入本文的材料。据述以引用方式并入本文但与本文所述的现有定义、陈述或其他公开材料相冲突的任何材料或其部分,仅在所并入的材料和现有公开材料之间不产生冲突的程度下并入本文。
尽管本发明已被描述为具有示例性的设计,但可在本公开的实质和范围内对本发明进行进一步修改。因此本申请旨在涵盖采用本发明一般原理的任何变型、用途或修改型式。此外,本申请旨在涵盖本发明所属领域中属于已知或惯有实践范围内的与本公开不同的型式。

Claims (25)

1.一种与外科器械一起使用的端部执行器组件,所述端部执行器组件包括:
紧固件仓,所述紧固件仓包括:
多个腔;和
狭槽;
多个紧固件,其中每个所述紧固件被定位在所述腔中;
第一连接器和第二连接器;
材料层,所述材料层通过所述第一连接器并通过所述第二连接器可释放地固定到所述紧固件仓,其中所述紧固件被构造成能够在所述紧固件运动到击发位置时至少部分地捕获所述材料层,其中所述材料层包括安装件,并且其中当所述材料层被固定到所述紧固件仓时,所述安装件延伸到位于所述第一连接器与所述第二连接器中间的所述狭槽中。
2.根据权利要求1所述的端部执行器组件,其中所述材料层包括支撑材料或组织厚度补偿件中的一者。
3.根据权利要求1所述的端部执行器组件,包括用于使所述安装件挠曲并将所述安装件从所述狭槽释放的挠曲-释放装置。
4.根据权利要求3所述的端部执行器组件,其中所述挠曲-释放装置被构造成能够沿所述狭槽运动经过所述安装件,并且其中当所述挠曲-释放装置运动经过所述安装件时,所述挠曲-释放装置使所述安装件挠曲。
5.根据权利要求1所述的端部执行器组件,其中所述安装件包括:
柔性杆;和
头部,所述头部从所述柔性杆延伸,其中当所述材料层被固定到所述紧固件仓时,所述头部装配在所述狭槽中。
6.根据权利要求5所述的端部执行器组件,包括击发元件,所述击发元件被构造成能够沿所述狭槽运动经过所述头部,其中所述柔性杆在所述击发元件运动经过所述头部时挠曲,并且其中当所述柔性杆挠曲时,所述头部从所述狭槽脱开。
7.根据权利要求6所述的端部执行器组件,其中所述击发元件包括切割刃,并且其中当所述击发元件沿所述狭槽运动时,所述切割刃切断所述材料层。
8.根据权利要求6所述的端部执行器组件,其中所述狭槽沿所述紧固件仓纵向延伸,并且其中所述材料层包括多个安装件,当所述材料层被固定到所述紧固件仓时,所述多个安装件延伸到所述狭槽中。
9.根据权利要求8所述的端部执行器组件,其中当所述击发元件沿所述狭槽运动经过每个所述安装件时,所述击发元件使每个所述安装件挠曲。
10.根据权利要求1所述的端部执行器组件,其中所述安装件包括纵向脊,并且其中所述纵向脊与所述材料层一体成型。
11.根据权利要求10所述的端部执行器组件,其中所述纵向脊包括所述材料层的折叠部分。
12.根据权利要求1所述的端部执行器组件,其中所述材料层包括加强特征结构。
13.一种与外科器械一起使用的端部执行器组件,所述端部执行器组件包括:
紧固件仓,所述紧固件仓包括:
多个紧固件,所述多个紧固件可移除地定位在所述紧固件仓中,其中每个所述紧固件被构造成能够从非击发位置运动到击发位置;
第一凹口,所述第一凹口位于所述紧固件仓的第一侧上;和
第二凹口,所述第二凹口位于所述紧固件仓的第二侧上;和
材料层,所述材料层可释放地固定到所述紧固件仓,其中当所述紧固件从所述非击发位置运动到所述击发位置时,所述材料层至少部分地被所述紧固件捕获,并且其中所述材料层包括:
位于第一侧上的第一安装件;和
位于第二侧上的第二安装件,其中当所述材料层被固定到所述紧固件仓时,所述第一安装件延伸到所述第一凹口中,并且所述第二安装件延伸到所述第二凹口中。
14.根据权利要求13所述的端部执行器组件,包括第一附接特征结构和第二附接特征结构,其中所述第一附接特征结构和所述第二附接特征结构被构造成能够将所述材料层附接到所述紧固件仓,并且其中所述第一凹口和所述第二凹口位于所述第一附接特征结构与所述第二附接特征结构中间。
15.根据权利要求13所述的端部执行器组件,其中所述第一安装件和所述第二安装件与所述材料层一体成型。
16.根据权利要求13所述的端部执行器组件,其中所述第一凹口定位在所述紧固件仓的边缘上,并且其中所述第二凹口定位在所述紧固件仓的相对的边缘上。
17.根据权利要求13所述的端部执行器组件,其中所述紧固件仓包括纵向狭槽,并且其中所述第一凹口和所述第二凹口与所述纵向狭槽相交。
18.一种与外科器械一起使用的端部执行器组件,所述端部执行器组件包括:
砧座;
紧固件仓,所述紧固件仓包括:
平台;
多个腔,所述多个腔被限定在所述平台中;和
多个紧固件,其中每个所述紧固件可移除地定位在所述腔中,并且其中所述紧固件被构造成能够从非击发位置运动到击发位置;以及
材料层,所述材料层可释放地固定在所述砧座与所述紧固件仓之间,其中所述紧固件被构造成能够在所述紧固件从所述非击发位置运动到所述击发位置时捕获所述材料层的至少一部分,其中所述材料层包括周边,并且其中所述周边包括圆齿状部分。
19.根据权利要求18所述的端部执行器组件,其中所述材料层包括支撑材料或组织厚度补偿件中的一者。
20.根据权利要求18所述的端部执行器组件,其中所述材料层包括加强特征结构。
21.根据权利要求20所述的端部执行器组件,其中所述加强特征结构包括沿所述材料层的长度延伸的肋。
22.根据权利要求18所述的端部执行器组件,其中所述材料层包括:
远侧部分;和
位于所述远侧部分处的安装件,其中当所述材料层可释放地固定在所述砧座与所述紧固件仓之间时,所述安装件延伸到所述砧座和所述紧固件仓之一的凹口中。
23.一种与外科器械一起使用的端部执行器组件,所述端部执行器组件包括:
砧座;
紧固件仓,所述紧固件仓包括多个腔;
多个紧固件,其中每个所述紧固件可移除地定位在所述腔中;
凹口;以及
材料层,所述材料层可释放地固定在所述砧座与所述紧固件仓之间,其中所述材料层被构造成能够在所述紧固件被从所述紧固件腔击发时至少部分地被所述紧固件捕获,并且其中所述材料层包括:
远侧部分;和
位于所述远侧部分处的安装件,其中当所述材料层可释放地固定在所述砧座与所述紧固件仓之间时,所述安装件装配在所述凹口中。
24.根据权利要求23所述的端部执行器组件,其中所述安装件形成V形形状。
25.根据权利要求23所述的端部执行器组件,其中所述凹口为第一凹口,其中所述端部执行器组件包括第二凹口,其中所述第一凹口被限定在所述砧座中,并且所述第二凹口被限定在所述紧固件仓中,并且其中所述材料层包括:
砧座表面,其中所述安装件为第一安装件,并且其中所述第一安装件从所述砧座表面延伸到所述第一凹口中;和
仓表面,所述仓表面包括第二安装件,其中所述第二安装件从所述仓表面延伸到所述第二凹口中。
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US13/097,954 US10136890B2 (en) 2010-09-30 2011-04-29 Staple cartridge comprising a variable thickness compressible portion
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