CN104334093A - 用于将组织厚度补偿材料附接到外科缝合器械的装置和方法 - Google Patents
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Abstract
本发明公开了外科缝合器械。至少一个实施例包括支撑多个外科钉的第一钳口和相对于所述第一钳口可运动的第二钳口。各种装置包括组织厚度补偿件,该组织厚度补偿件能够被捕获在所述外科钉内并且能够在对所述外科钉施加击发动作时在不同的外科钉内呈现不同的压缩高度。各种附接突起装置被公开以将组织厚度补偿件机械地附接到第一钳口或第二钳口。
Description
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。
1.一种外科缝合器械,包括:
第一钳口,所述第一钳口在其中支撑多个外科钉,所述多个外科钉能够操作地响应于对其施加的击发动作;
第二钳口,所述第二钳口能够相对于所述第一钳口运动地支撑,以使得在对所述第二钳口施加闭合动作时,所述第二钳口的一部分能够相对于所述第一钳口运动成面对关系;
组织厚度补偿件,所述组织厚度补偿件能够被捕获在所述外科钉内并且能够在对所述外科钉施加所述击发动作时在不同的外科钉内呈现不同的压缩高度;以及
至少一个附接突起,所述至少一个附接突起位于所述第一钳口和第二钳口中的至少一个上以用于将所述组织厚度补偿件的对应部分可移除地机械附连到对应钳口。
2.根据实施例1所述的外科缝合器械,其中所述组织厚度补偿件包括纤维主体结构,并且其中所述至少一个附接突起包括能够可移除地保持接合所述纤维主体结构的多个附接突起。
3.根据实施例1或实施例2所述的外科缝合器械,其中所述组织厚度补偿件包括由膜封装的可压缩主体,并且其中所述至少一个附接突起能够可移除地保持接合所述膜上的至少一个其它对应的其它附接突起。
4.根据前述实施例中任一项所述的外科缝合器械,其中所述至少一个附接突起包括以下的至少一个区域:
具有棱锥形状的附接突起;
具有六边形形状的附接突起;
包括突起主体部分和与所述主体部分不共轴的远端部分的附接突起;
包括大于其横截面积的高度的附接柱;
钩形附接突起;
环形突起;
T形突起;和
微纤维。
5.根据实施例3所述的外科缝合器械,其中所述膜包括形成于其上的至少一个流体芯吸构件区域。
6.根据前述实施例中任一项所述的外科缝合器械,其中所述组织厚度补偿件包括由织造材料制成的可压缩主体。
7.根据权利要求1-5中任一项所述的外科器械,其中所述组织厚度补偿件包括由非织造材料制成的可压缩主体。
8.根据前述实施例中任一项所述的外科缝合器械,其中所述第一钳口包括限定平台表面的仓体,所述平台表面包括穿过所述平台表面的多个钉腔,并且其中所述多个外科钉被定位在所述钉腔内。
9.根据实施例8所述的外科缝合器械,其中所述至少一个附接突起从所述平台表面突起。
10.根据实施例8或实施例9所述的外科缝合器械,其中所述至少一个附接突起一体地形成在所述平台表面上。
11.根据权利要求8-10中任一项所述的外科缝合器械,其中所述组织厚度补偿件包括纤维主体结构,并且其中所述至少一个附接突起包括能够可移除地保持接合所述纤维主体结构的多个附接突起。
12.根据权利要求8-11中任一项所述的外科缝合器械,其中所述组织厚度补偿件包括由膜封装的可压缩主体,并且其中所述至少一个附接突起能够可移除地保持接合所述膜上的对应的至少一个其它附接突起。
13.根据权利要求8-12中任一项所述的外科缝合器械,其中所述仓体包括穿过所述平台表面形成的纵向延伸的平台狭槽以用于在其中接收组织切割构件的一部分,并且其中所述至少一个附接突起包括位于所述平台狭槽的一侧的至少一个附接突起区域和位于所述平台狭槽的另一侧的至少一个其它附接突起区域。
14.根据前述实施例中任一项所述的外科缝合器械,其中所述第二钳口包括砧座,所述砧座在其上包括钉成形表面,并且其中所述至少一个附接突起从所述钉成形表面突起。
15.根据实施例14所述的外科缝合器械,其中所述至少一个附接突起包括形成于对应的附接载体上的附接突起区域,所述对应的附接载体能够保持联接到所述砧座。
16.根据实施例15所述的外科缝合器械,其中所述对应的附接载体中的每个能够卡扣地接合所述砧座。
17.根据实施例15或实施例16所述的外科缝合器械,其中所述附接突起区域由粘合剂附接到所述对应的附接载体。
18.根据实施例15或实施例16所述的外科缝合器械,其中所述附接突起区域一体地形成在所述对应的附接载体上。
19.一种外科手术缝合器械,包括:
钉仓,所述钉仓包括:
仓体,所述仓体限定平台表面,所述平台表面具有穿过所述平台表面的多个钉腔;
定位在所述钉腔内的多个钉;
砧座,所述砧座在其上包括钉成形表面并且能够相对于所述钉仓运动地支撑,使得所述钉成形表面响应于对所述砧座施加的闭合动作而相对于所述仓体的平台表面形成面对关系;
组织厚度补偿件,所述组织厚度补偿件能够被捕获在所述钉内并且在不同的钉内呈现不同的压缩高度;和
至少一个附接突起区域,所述至少一个附接突起区域位于所述砧座的钉成形表面上以用于将所述组织厚度补偿件可移除地附接到所述钉成形表面。
20.一种外科缝合器械,包括:
钉仓,所述钉仓包括:
仓体,所述仓体限定平台表面,所述平台表面包括穿过所述平台表面的多个钉腔;
定位在所述钉腔内的多个钉;
砧座,所述砧座在其上包括钉成形表面并且能够相对于所述钉仓运动地支撑,使得所述钉成形表面响应于对所述砧座施加的闭合动作而相对于所述仓体的平台表面形成面对关系;
组织厚度补偿件,所述组织厚度补偿件能够被捕获在所述钉内并且在不同的钉内呈现不同的压缩高度;和
至少一个附接突起区域,所述至少一个附接突起区域位于所述平台表面上以用于将所述组织厚度补偿件可移除地附接到所述平台表面。
21.一种外科缝合器械,包括:
第一钳口,所述第一钳口在其中支撑多个外科钉,所述多个外科钉能够操作地响应于对其施加的击发动作;
第二钳口,所述第二钳口能够相对于所述第一钳口运动地支撑,使得在对所述第二钳口施加闭合动作时,所述第二钳口的一部分能够相对于所述第一钳口运动成面对关系;
组织厚度补偿件,所述组织厚度补偿件能够被捕获在所述外科钉内并且能够在对所述外科钉施加所述击发动作时在不同的外科钉内呈现不同的压缩高度,所述组织厚度补偿件能够在所述组织厚度补偿件与所述第一钳口和第二钳口中的一者之间建立抽吸保持力。
22.一种外科钉仓,包括:
仓体,所述仓体限定平台表面,所述平台表面包括穿过所述平台表面的多个钉腔;
定位在所述钉腔内的多个钉;和
至少一个附接突起区域,所述至少一个附接突起区域位于所述平台表面上以用于将组织厚度补偿件可移除地附接到所述平台表面。
发明内容
根据至少一个一般形式,提供了一种外科缝合器械。在至少一个形式中,外科缝合器械包括第一钳口,所述第一钳口支撑多个外科钉,所述多个外科钉能够操作地响应于对其施加的击发动作。第二钳口能够相对于第一钳口运动地支撑,使得在对第二钳口施加闭合动作时,第二钳口的一部分可相对于第一钳口运动成面对关系。组织厚度补偿件能够被捕获在外科钉内并且能够在对外科钉施加击发动作时在不同的外科钉内呈现不同的压缩高度。至少一个附接突起设置在第一钳口和第二钳口中的至少一个上,以用于将组织厚度补偿件的对应部分可移除地机械地附连到对应钳口。
根据至少一个其它一般形式,提供了一种外科缝合器械。在至少一个形式中,外科缝合器械包括钉仓,所述钉仓包括仓体,所述仓体限定平台表面,所述平台表面具有贯穿延伸的多个钉。多个钉被定位在钉腔内。所述器械还包括砧座,所述砧座具有钉成形表面并且能够相对于钉仓运动地支撑,使得钉成形表面响应于对砧座施加的闭合动作而相对于仓体的平台表面形成面对关系。组织厚度补偿件能够被捕获在钉内并且在不同的钉内呈现不同的压缩高度。至少一个附接突起区域设置在砧座的钉成形表面上,以用于将组织厚度补偿件可移除地附接到所述钉成形表面。
根据又一个一般形式,提供了一种外科缝合器械。在至少一个形式中,所述外科缝合器械包括钉仓,所述钉仓包括仓体,所述仓体限定平台表面,所述平台表面具有贯穿延伸的多个钉。多个钉被定位在钉腔内。所述外科缝合器械还包括砧座,所述砧座在其上具有钉成形表面并且能够相对于钉仓运动地支撑,使得钉成形表面响应于对砧座施加的闭合动作而相对于仓体的平台表面形成面对关系。组织厚度补偿件能够被捕获在钉内并且在不同的钉内呈现不同的压缩高度。所述装置还包括至少一个附接突起区域,所述至少一个附接突起区域位于平台表面上以用于将组织厚度补偿件可移除地附接到所述平台表面。
根据其它一般方面,提供了一种外科缝合器械,所述外科缝合器械具有在其中支撑多个外科钉的第一钳口,所述外科钉能够操作地响应于对其施加的击发动作。所述外科缝合器械包括第二钳口,所述第二钳口能够相对于第一钳口运动地支撑,使得在对第二钳口施加闭合动作时,第二钳口的一部分可相对于第一钳口运动成面对关系。所述器械还包括组织厚度补偿件,所述组织厚度补偿件能够被捕获在外科钉内并且能够在对外科钉施加击发动作时在不同的外科钉内呈现不同的压缩高度。在至少一个实施例中,所述组织厚度补偿件还能够在所述组织厚度补偿件与第一钳口和第二钳口中的一者之间建立抽吸保持力。
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为可结合各种实施例使用的外科缝合器械的侧视图;
图2为沿图1中的线2-2截取的图1的外科缝合器器械的端部执行器部分的剖视图;
图3为其砧座处于打开位置的图2所示的端部执行器的端部透视图;
图4为图1的外科缝合器械的一部分的分解组件图;
图5为一个实施例的砧座的一部分的透视图;
图6为示出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7为示出向已被钉线横切的一根或多根血管施加压缩力的组织厚度补偿件的示意图;
图8为示出其中一个或多个钉未恰当成形的情况的示意图;
图9为示出可补偿未恰当成形钉的组织厚度补偿件的示意图;
图10为示出被定位在多个钉线已相交的组织区域中的组织厚度补偿件的示意图;
图11为示出被捕获在钉内的组织的示意图;
图12为示出被捕获在钉内的组织和组织厚度补偿件的示意图;
图13为示出被捕获在钉内的组织的示意图;
图14为示出被捕获在钉内的厚组织和组织厚度补偿件的示意图;
图15为示出被捕获在钉内的薄组织和组织厚度补偿件的示意图;
图16为示出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17为示出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18为示出被捕获在钉内的厚组织和组织厚度补偿件的示意图;
图19为图5的砧座和组织厚度补偿件实施例的底视图;
图20为一个实施例的突起区域的一部分的透视图;图21为另一个实施例的突起区域的一部分的透视图;
图22为另一个实施例的突起区域的一部分的透视图;
图23为砧座和组织厚度补偿件实施例的局部透视图;
图24为砧座和组织厚度补偿件实施例的局部分解组件图;
图25为图11的砧座的一部分的剖视图,其中组织厚度补偿件附接到该砧座;
图26为另一个砧座和组织厚度补偿件实施例的局部分解组件图;
图27为图26的砧座的一部分的剖视图,其中组织厚度补偿件附接到该砧座;
图28为另一个砧座和组织厚度补偿件实施例的局部分解组件图;
图29为图28的砧座的一部分的剖视图,其中组织厚度补偿件附接到该砧座;
图30为另一个砧座和组织厚度补偿件实施例的局部分解组件图;
图31为图30的砧座的一部分的透视图;
图32为另一个砧座和组织厚度补偿件实施例的局部分解组件图;
图33为图32的砧座的一部分的透视图;
图34为另一个砧座和组织厚度补偿件实施例的局部分解组件图;
图35为图34的砧座的一部分的透视图;
图36为另一个端部执行器实施例和组织厚度补偿件实施例的局部侧视图;
图37为图36的端部执行器和组织厚度补偿件的一部分的放大视图;
图38为另一个砧座和组织厚度补偿件实施例的局部分解组件图;
图39为模具实施例的剖视图;
图40为图38的组织厚度补偿件的一部分的透视图;并且
图41为另一个端部执行器实施例和组织厚度补偿件实施例的透视图。
贯穿若干视图,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 COMPRISINGA PLURALITY OF MEDICAMENTS”(代理人案卷号END7102USNP/110604)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。此类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。此类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,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置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中,包括与开放式外科手术结合。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中,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直接插入患者体中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,其中类似的数字在全部若干视图中代表类似的部件,图1和图2示出了外科缝合和切断器械10。示例性外科缝合和切断器械更详细地描述于2008年4月29日公布的名称为“Surgical Stapling InstrumentIncorporating a Multistroke Firing Position Indicator and Retraction Mechanism”的美国专利7,364,061中,该专利的全部公开内容以引用方式并入本文。多种其它外科缝合和切断器械是已知的。继续参阅本具体实施方式,本领域的普通技术人员将理解本发明的独特和新颖属性可有效地结合各种其它形式的外科缝合和切断器械来使用,且不脱离本发明的实质和范围。例如,其它形式的外科缝合和切断器械公开于名称为“Surgical Stapling Instrument HavingSeparate Distinct Closing and Firing Systems”的美国专利号7,000,818中,该专利的公开内容全文以引用方式并入本文。其它外科缝合器械可包括例如开放式外科缝合器、线性外科缝合器、圆形外科缝合器等等。
参见图1和图2,示例性的外科缝合和切断器械10包括端部执行器12,该端部执行器12具有相对于第一钳口13枢转地支撑的第二钳口15。例如,第一钳口13包括能够操作地支撑外科钉仓120的细长通道16,并且第二钳口15包括能够运动地附接到细长通道16的砧座100。端部执行器12通过轴18联接到柄部20。在由抓握柄部20的外科医生控制时,由端部执行器12和轴18形成的执行部分22的尺寸可有利地设定成插过套管针或小的腹腔镜开口以执行内窥镜式外科手术。柄部20有利地包括以下特征结构,所述特征结构允许端部执行器12的闭合动作与击发动作的分离、以及允许启用多个击发行程以用于施加击发动作来实现端部执行器12的击发(即,切断和缝合),同时向外科医生指示击发的程度。
为了这些目的,将轴18的闭合管24联接在闭合触发器26和砧座100之间,以使端部执行器12的闭合。在闭合管24内,框架28联接在细长通道16和柄部20之间,以纵向地定位和支撑端部执行器12。旋钮30与框架28联接,并且这两个元件可旋转地联接到柄部20以实现围绕轴18的纵向轴线的旋转运动。此类构造使得外科医生能够通过旋转旋钮30来旋转端部执行器12。闭合管24也通过旋钮30进行旋转,但保持相对于旋钮的纵向运动程度,以使端部执行器12闭合。在框架28内,击发连杆32被定位用于纵向运动并且联接在端部执行器12的砧座100和多行程击发触发器34之间。闭合触发器26位于柄部20的手枪式握把36的远侧,并且击发触发器34位于手枪式握把36和闭合触发器26两者的远侧。
在内窥镜式操作中,一旦执行部分22插入患者体中以接触手术部位,外科医生就参照内窥镜装置或其它诊断成像装置来将组织定位在砧座100和细长通道16之间。通过抓握闭合触发器26和手枪式握把36,外科医生可重复地抓握和定位组织。一旦对组织相对于端部执行器12的位置和在其中的组织的量满意,外科医生就将闭合触发器26完全地按压到手枪式握把36,由此夹紧端部执行器12中的组织并且将闭合触发器26锁定在此夹紧(闭合)位置。如果不满意此定位,则外科医生可通过按压闭合释放按钮38来释放闭合触发器26,并且然后重复此过程以夹紧组织。
如果夹紧为恰当的,则外科医生可继续击发外科缝合和切断器械10。具体地,外科医生抓握击发触发器34和手枪式握把36,按压击发触发器34预定次数。基于以下因素来符合人体工程学地确定所需的击发行程的数目:最大的手尺寸、每次击发行程期间施加到器械的力的最大量、以及击发期间需要通过击发连杆32传递到端部执行器12的纵向距离和力。
可使用的其它外科缝合和切断器械包括用于推进和回缩钉驱动滑动件和刀组件的马达动力传动轴构造。此类器械的实例公开于名称为“PoweredArticulatable Surgical Cutting and Fastening Instrument With Flexible DriveMember”的美国专利8,020,743中,该专利的全部公开内容以引用方式并入本文。也可使用机器人控制的外科切割和切断器械,诸如2011年5月27日提交的名称为“Surgical Stapling Instruments With Rotatable Staple DeploymentArrangements”的美国专利申请序列号13/118,241中所公开的那些,该专利的全部公开内容以引用方式并入本文。
现在参见图4,执行部分22还包括响应击发连杆32的击发动作的部件。根据本发明,击发连杆32的远端可旋转地接合具有纵向凹槽68的击发槽构件66。击发槽构件66直接响应击发连杆32的纵向运动而在框架28内纵向运动。闭合管24中的纵向狭槽70能够操作地联接旋钮30,并且与纵向狭槽70径向对准的框架28中的短纵向狭槽72被接合到旋钮30。闭合管24中的纵向狭槽70的长度为足够长的,以便允许利用旋钮30的相对纵向运动,由此分别实现击发动作和闭合动作。
如图所示,框架槽构件66的远端附接到击发杆76的近端,该击发杆76随在其中包括导向装置78的框架28运动,使得E形梁80朝远侧突起到端部执行器12中。如上所示,端部执行器12包括由E形梁80致动的钉仓120。钉仓120具有保持钉仓体126、楔形滑动件驱动器128、钉驱动器130和钉132的托盘122。应当理解,楔形滑动件驱动器128在位于仓托盘122和仓体126之间的凹槽134内纵向运动。楔形滑动件驱动器128存在接触并向上提升钉驱动器130的凸轮表面,以从钉孔136向上驱动钉132来接触砧座100的钉成形表面102的钉成形凹坑104,从而产生成形的“B”形钉。具体地参照图3,钉仓体126还包括朝近侧开放的、竖直的平台狭槽127,用于E形梁80的通道。沿着E形梁80的远端提供了切割表面82,以在组织被缝合后来切割组织。
在示出的实例中,砧座100首先通过包括砧座安装部分105来响应来自柄部20的闭合动作,所述砧座安装部分包括一对侧向突出的砧座耳轴108,所述砧座耳轴位于竖直突出的砧座特征110的远侧(图4)。砧座耳轴108在细长通道16中的肾形开口58内平移,以相对于细长通道16来打开和闭合砧座100。砧座特征56接合弯曲凸块59(图2),该弯曲凸块向内延伸到位于闭合管24的远端62的凸块孔60(图4)中,后者朝远侧端接推压安装部分104的远侧边缘64。因此,当闭合管24从其打开位置朝近侧运动时,闭合管24的弯曲凸块59朝近侧牵拉砧座特征110,并且砧座枢转耳轴108沿着槽16的肾形开口58运动,使得砧座100同时地朝近侧移动并向上旋转到打开位置。当闭合管24朝远侧运动时,凸块孔60从砧座特征110释放,并且远侧边缘64推压在砧座安装部分104上,从而闭合砧座100。
具体地,示出了有利于端部执行器12的击发的E形梁80的特征。在图2中,楔形滑动件驱动器128位于其完全近侧位置,由此来指示未击发的钉仓120。中间销83被对准,以进入钉仓120中的击发凹槽127,从而朝远侧驱动楔形滑动件驱动器128。E形梁80的底部销或盖85沿细长通道16的底表面滑动,因此中间销83和底部销85滑动地接合细长通道16。在图2的打开和未击发状态下,E形梁80的顶部销87位于砧座100的砧座凹坑112内,并且因此不会阻止砧座100的重复打开和闭合。当端部执行器12处于夹紧和预击发状态时,E形梁80的顶部销87与砧座100中的砧座狭槽114对准,该砧座狭槽位于砧座凹坑112的远侧并且与砧座凹坑112连通。当端部执行器被击发时,E形梁80朝远侧推进穿过端部执行器,以切割组织并且击发钉。当E形梁80朝远侧运动时,上部销87沿着砧座狭槽114平移,从而在切割表面82切断夹紧的组织时肯定将砧座100与细长通道16间隔开。同时,中间销85已致动钉仓120。然后,E形梁80在打开端部执行器12和替换钉仓120之前回缩,以用于另外的操作。
任选地,如上所述,钉仓120可包括在其中具有多个钉腔140的仓体126。仓体126可包括具有顶部平台表面144的平台142,其中每个钉腔140在平台表面144中限定开口。另外如上所述,钉132定位在每个钉腔140内,使得钉132被储存在仓体126内直到其从仓体射出。在从仓体126射出之前,钉132可容纳在仓体126内,使得钉132不突起到平台表面144上方。当钉132定位在平台表面144下方时,在这种情况下,可降低钉132被损坏和/或过早接触目标组织的可能性。在各种情况下,钉132可在未击发位置和击发位置之间运动,在未击发位置时,其不从仓体126突出;在击发位置时,其已从仓体126露出并且可接触定位在钉仓120对面的砧座100。砧座100和/或限定在砧座100内的成形凹坑104可在平台表面144上方定位预定距离,使得当钉132从仓体126被部署时,钉132变形为预定的成形高度。在一些情况下,被捕获在砧座100和钉仓120之间的组织的厚度可变化,因此,较厚组织可被捕获在某些钉132内而较薄组织可被捕获在某些其它钉132内。在任一种情形下,由钉132施加到组织的夹紧压力或力可例如因钉而异,或可在钉排的一端上的钉和钉排的另一端上的钉之间变化。在某些情况下,可控制砧座100和钉仓平台142之间的间隙,使得钉132在每个钉132内施加某一最小夹紧压力。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。
首先参见图6并且如下文更详细所述,每个钉132可包括基部133和从基部133延伸的一个或多个腿135。在钉132被部署之前,钉132的基部133可由定位在仓体126内的钉驱动器130支撑,并且同时钉132的腿135可至少部分地容纳在钉腔140内。
用于补偿被捕获在从钉仓部署的钉内的组织的厚度的各种装置公开于2011年4月29日提交的名称为“Tissue Thickness Compensator For a SurgicalStapler Comprising An Adjustable Anvil”的美国专利申请序列号13/097,891中,该专利申请的全部公开内容以引用方式并入本文。使用组织厚度补偿件200。钉132可在未击发位置和击发位置之间被部署,使得腿135运动穿过组织厚度补偿件200,穿透组织厚度补偿件200的顶表面,穿透组织T,并且接触被定位在钉仓120对面的砧座100。当腿135抵靠砧座100变形时,每个钉132的腿135可将组织厚度补偿件200的一部分和组织T的一部分捕获在每个钉132内,并且可对组织T施加压缩力。对上文进行进一步描述,每个钉132的腿135可向下朝钉132的基部133变形,以形成可捕获组织T和组织厚度补偿件200的钉截留区域137。在各种情况下,钉截留区域137可被限定在已变形的腿135的内表面和基部133的内表面之间。钉截留区域的尺寸可取决于若干因素,诸如例如腿的长度、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。图11示出了用于薄组织中的高钉。现在参见图12,当组织厚度补偿件(诸如,组织厚度补偿件200)例如用于薄组织内时,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6和图7,组织厚度补偿件(例如组织厚度补偿件200)例如可根据钉截留区域137内容纳的组织的厚度和/或类型来占据每个钉132的钉截留区域137的较大和/或较小部分。例如,相比于较厚的组织T被捕获在钉132内的情形,如果较薄的组织T被捕获在钉132内,则组织厚度补偿件200可占据钉截留区域137的较大部分。相应地,相比于较薄的组织T被捕获在钉132内的情形,如果较厚的组织T被捕获在钉132内,则组织厚度补偿件200可占据钉截留区域137的较小部分。这样,组织厚度补偿件200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200可对被捕获在不同钉132内的不同类型或不同压缩率的组织进行补偿。现在参见图7,组织厚度补偿件200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200还可补偿已变形的钉。参见图8,各种钉132的变形可导致限定在此类钉内的较大的钉截留区域137。由于组织厚度补偿件200的回弹力,现在参见图9,即使被限定在此类已变形钉132内的钉截留区域137可被扩大,定位在已变形钉132内的组织厚度补偿件200仍可将足够的压缩力施加到组织。在各种情况下,位于邻近钉132中间的组织厚度补偿件200可被已变形钉132周围的适当成形的钉132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132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另加的压缩力施加到组织。现在参见图13-18,钉132已成形为预定的高度H。参照图13,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137。参照图14,组织厚度补偿件200的一部分已被捕获在钉132内,已将组织T压缩,并且已占据钉截留区域137的至少一部分。现在参见图15,薄组织T已被捕获在钉132内。在该实施例中,例如,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200具有大约7/9H的高度。现在参见图16,具有中间厚度的组织T已被捕获在钉132内。在该实施例中,例如,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200具有大约5/9H的高度。现在参见图17,具有中间厚度的组织T已被捕获在钉132内。在该实施例中,例如,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200具有大约1/3H的高度。现在参见图18,厚组织T已被捕获在钉132内。在该实施例中,例如,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200具有大约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132可包括任何合适的未成形高度。钉132可包括例如介于大约2mm和大约4.8mm之间的未成形高度。钉132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可由钉仓126的平台表面144和相对的砧座100之间的距离来决定。平台表面144和砧座100的钉成形表面102之间的距离可为例如大约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量的深度。
如上所述,钉仓120包括钉驱动器130,该钉驱动器可朝砧座100提升钉132并且可将钉提升或“过度驱动”到平台表面144上方。在这种情况下,钉132成形的高度H还可由钉132被过度驱动的距离来决定。例如,钉132可被过度驱动例如大约.028",并且可导致钉132被成形为例如大约0.189"的高度。钉132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132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132的钉截留区域137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",从而产生例如大约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,可使钉线或钉排内的钉变形,使得每个钉的钉截留区域包括例如大约2.0mm的高度,其中组织T和组织厚度补偿件可被压缩到该高度以内。在某些情形下,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聚合物组合物。聚合物组合物可包括一种或多种合成聚合物和/或一种或多种非合成聚合物。合成聚合物可包括合成的可吸收聚合物和/或合成的非可吸收聚合物。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,在一个方向在整个泡沫厚度上,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的存在下扩展,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/或天然源的材料,并且例如可为生物耐用的和/或可生物降解的。可利用能够提供附加柔韧性、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。
非合成聚合物的实例包括但不限于冻干多糖、糖蛋白类、弹性蛋白、蛋白聚糖、明胶、胶原和氧化再生纤维素(ORC)。合成的可吸收聚合物的实例包括但不限于聚(乳酸)(PLA)、聚(L-乳酸)(PLLA)、聚己内酯(PCL)、聚乙醇酸(PGA)、聚(三亚甲基碳酸酯)(TMC)、聚对苯二甲酸乙二酯(PET)、多羟基链烷酸酯(PHA)、乙交酯和ε-己内酯(PGCL)的共聚物、乙交酯和三亚甲基碳酸酯的共聚物、聚(癸二酸甘油酯)(PGS)、聚对二氧环己酮、聚(原酸酯)、聚酸酐、多糖、聚(酯-酰胺)、酪氨酸基聚芳酯、酪氨酸基聚亚氨碳酸酯、酪氨酸基聚碳酸酯、聚(D,L-丙交酯-氨基甲酸酯)、聚(B-羟基丁酸)、聚(E-己内酯)、聚乙二醇(PEG)、聚[二(羧基苯氧基)磷腈]、聚(氨基酸)、拟聚(氨基酸)、可吸收的聚氨酯以及它们的组合。聚合物组合物可包括例如按重量计大约50%至大约90%的PLLA的聚合物组合物和按重量计大约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和按重量计大约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的聚合物组合物和按重量计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和按重量计大约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的聚合物组合物和按重量计大约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。
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商购获得的75/25聚(乙交酯-E-己内酯-poliglecaprolactone 25)共聚物中的一种或多种。
合成的非可吸收聚合物包括但不限于聚氨酯泡沫塑料、聚丙烯(PP)、聚乙烯(PE)、聚碳酸酯、聚酰胺,例如尼龙、聚氯乙烯(PVC)、聚甲基丙烯酸甲酯(PMMA)、聚苯乙烯(PS)、聚酯、聚醚醚酮(PEEK)、聚四氟乙烯(PTFE)、聚三氟氯乙烯(PTFCE)、聚氟乙烯(PVF)、氟化乙烯丙烯(FEP)、聚缩醛、聚砜、以及它们的组合。合成的非可吸收聚合物可包括但不限于弹性体泡沫塑料和多孔弹性体,例如硅氧烷、聚异戊二烯和橡胶。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。
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%至大约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微米至大约2000微米的孔尺寸。聚合物组合物可具有例如介于大约10微米至大约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微米至大约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 Rubber Property-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,诸如例如15秒,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ASTM D2240-00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例如大约4A至大约16A的肖氏硬度A值,该肖氏硬度A值在大约45OO至大约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的肖氏硬度A值。组织厚度补偿件的聚合物组合物可具有小于10A的肖氏硬度A值。组织厚度补偿件的聚合物组合物可具有小于5A的肖氏硬度A值。聚合物材料可具有例如大约35OO至大约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%至97%的孔隙率、5微米至2000微米的孔尺寸、和4A至16A的肖氏硬度A值以及45OO至65OO的肖氏硬度OO值。聚合物组合物可包括按重量计70%的PLLA的聚合物组合物和按重量计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微米至1000微米的孔尺寸、和4A至16A的肖氏硬度A值以及45OO至65OO的肖氏硬度OO值。聚合物组合物可包括按重量计65%的PGA的聚合物组合物和按重量计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%至95%的孔隙率、10微米至100微米的孔尺寸、和4A至16A的肖氏硬度A值以及45OO至65OO的肖氏硬度OO值。
聚合物组合物可包含药物活性剂。聚合物组合物可释放治疗学上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)中。药物活性剂的实例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;和抗癌剂,例如顺铂、丝裂霉素、阿霉素。如本文所用,术语“组织厚度补偿件”可包含上述补偿件组合物中的任何一种。
公开了用于将各种组织厚度补偿件可移除地附接到外科缝合器械的第一和第二钳口13、15中的至少一个的装置。例如,图5和图19示出了砧座100的钉成形下表面102,该钉成形下表面包括至少一个附接突起区域150以用于将厚度补偿件可移除地附接到砧座100的钉成形表面102。例如,附接突起区域150可包括未被形成的钉成形凹坑104占据的整个钉成形表面102或者此表面102的较小百分比。在图5和图19中,例如,四个分立的附接突起区域150设置在砧座100的钉成形下表面102上,所述四个分立的附接突起区域150被设计用于配合设置在厚度补偿件200’上的对应的四个附接突起区域160。
厚度补偿件200’包括可压缩主体或泡沫构件202,该可压缩主体或泡沫构件可包括上文所述的各种泡沫组合物/构型中的任何一种。可压缩主体202可承载生物材料,例如,氧化再生纤维素“ORC”、血纤维蛋白、凝血酶、非织造可吸收聚合物股线、富含血小板的血浆、钙&白蛋白、胶原、透明质酸等等。泡沫构件202由膜204进行包装或密封或保护,以防经受流体。膜204可包括由65/35PCL/PGA制成的膜。然而,膜可由上文所述的可吸收聚合物或它们的共聚物中的任何一种制成。如在图19中可见,对应的附接突起区域160附接到膜204并且能够可移除地配合砧座100上的附接突起区域150。区域150、160可包括对应的钩和环构件的区域,所述钩和环构件以商品名进行市售。作为另外一种选择,区域150、160可包括具有突起主体部分172的突起170,所述突起主体部分具有基本上不与主体部分172同轴对准的远端174。例如,突起170可为一定程度地钩形的。参见图20。每个突起170的高度“H”可显著大于其横截面积。突起170可由例如上述类型的可吸收聚合物材料制成,例如,PGA、PCL、PLA、PEO(聚氧化乙烯)、TMC、DMTMC。然而,如果突起与所述装置保持在一起并且不是植入的,则突起可由例如规则尼龙、聚碳酸酯、Ultem或聚乙烯制成。此类突起170可例如被设置成每平方英寸面积大约130个至1700个突起的密度,使得当区域150和160形成配合接合时,厚度补偿件200’保持附连到砧座100的钉成形表面102。然而,突起170可由其它合适的材料制成并且可被设置成有助于将组织厚度补偿件200’可移除地附连到砧座100的其它合适的密度。因此,术语“附接突起区域”旨在涵盖能够可释放地接合组织厚度补偿件的至少一个附接突起以及各种密度的多附接突起构造。
作为另外一种选择,区域150、160可包括具有基本上六边形形状的突起180。如在图21中可见,例如,每个突起180从其基部182渐缩至六边形远端184。突起180可由例如上述类型的可吸收聚合物材料制成,例如,PGA、PCL、PLA、PEO(聚氧化乙烯)、TMC、DMTMC。然而,如果突起与所述装置保持在一起并且不是植入的,则突起可由例如规则尼龙、聚碳酸酯、Ultem或聚乙烯制成。此类突起180可例如被设置成每平方英寸面积大约130-1700个突起的密度,使得当区域150和160形成配合接合时,厚度补偿件200’保持附连到砧座100的钉成形表面102。然而,突起180可由其它合适的材料制成并且可被设置成其它有助于将组织厚度补偿件200可移除地附连到砧座100的合适的密度。
作为另外一种选择,区域150、160可包括基本上椎体形状的突起190。如在图22中可见,例如,每个突起190具有从基部192渐缩至尖形远端196的四个基本上三角形的侧面194。突起180可由例如上述类型的可吸收聚合物材料制成,例如,PGA、PCL、PLA、PEO(聚氧化乙烯)、TMC、DMTMC。然而,如果突起与所述装置保持在一起并且不是植入的,则突起可由例如规则尼龙、聚碳酸酯、Ultem或聚乙烯制成。此类突起180可例如被设置成每平方英寸面积大约130-1700个突起的密度,使得当区域150和160形成配合接合时,厚度补偿件200’保持附连到砧座100的钉成形表面102。然而,突起180可由其它合适的材料制成并且可被设置成有助于将组织厚度补偿件200’可移除地附连到砧座100的其它合适的密度。
所采用的附接突起的各种实施例用于将组织补偿件200’可移除地附接到砧座100,而不使用粘合剂作为唯一的附接介质,所述粘合剂通常不适于促进将组织补偿件200’可移除地附接到砧座。作为另外的可供选择的形式,可通过将聚苯乙烯颗粒添加到突起中来改善区域150和区域160之间的粘附力。它们还有助于避免用于将组织厚度补偿件200附接到砧座100的装置阻塞砧座100中的狭槽114。在任何情况下,一旦端部执行器12已被击发并且组织厚度补偿件已被切割并且缝合到靶组织,附接突起区域150、160就促进端部执行器12与组织厚度补偿件200分离。
作为另外的可供选择的形式,附接突起区域150可一体地形成在砧座100中。作为另外的可供选择的形式,附接突起区域150设置在钉仓120的平台表面144上并且能够保持的配合组织厚度补偿件200’上的对应突起区域160。作为另外一种选择,突起区域150可一体地形成在平台142中。区域150可进行定位,以便避免阻塞平台狭槽127。
图23示出了能够可移除地附接到砧座100的另一个组织厚度补偿件实施例300。组织厚度补偿件300包括可压缩主体或泡沫构件302,所述可压缩主体或泡沫构件可包括上文所述的各种泡沫组合物/构型中的任何一种。泡沫构件302由膜304进行包装或密封或保护,以防经受流体。膜304可包括由65/35PCL/PGA制成的膜。然而,膜可由上文所述的可吸收聚合物或它们的共聚物中的任何一种制成。可通过使用本文所公开的突起构造中的任何一个来将组织厚度补偿件300可移除地附接到砧座100的钉成形表面102。在该实施例中,膜304为基本上水溶性的,并且可具有形成于其中的纳米芯吸特征312的多个区域310。纳米芯吸特征可有助于促进亲水性芯吸,由此可有助于膜304的融化。作为另外一种选择,可通过本文所公开的突起构造中的任何一个来将组织厚度补偿件300附接到钉仓120。
图24和图25示出了另选的实施例,其中两个突起区域150形成于对应的附接载体410上,所述对应的附接载体能够卡扣到形成于砧座100中的对应的附接腔体420内。图24和图25所示的附接载体410包括附接平台412,该附接平台具有从其突起的附接杆414。杆414端接在尖卡口型顶端416中,该尖卡口型顶端能够卡扣接合对应的附接卡扣腔体420。本文所公开的各种形式的突起可一体地形成到附接载体410的平台412中,或者它们可通过适当的粘合剂附接到平台412。在图25中,突起430为钩形的,并且极其适用于将上文所述的各种类型和组合物的组织压缩构件400保持钩挂到砧座100。例如,组织压缩构件400可包括泡沫或纤维氧化再生纤维素(ORC)材料。附接载体并非为植入式的并且与砧座100保持在一起以供再利用。附接特征410被定位成使得突起区域150位于砧座100中的狭槽114的每侧并且使得它们不阻塞或妨碍钉成形凹坑104中的任何一个。一旦端部执行器12已被击发并且组织厚度补偿件400已被切割和缝合到靶组织,附接载体410就释放组织厚度补偿件400,而载体410保持附接到砧座100。作为另外一种选择,载体410可以类似的方式而非以紧固到砧座100的形式附接到钉仓120。
图26和图27示出了另选的实施例,其中两个突起区域150形成于对应的附接载体410’上,该对应的附接载体能够卡扣到形成于砧座100中的对应的附接腔体420’中。图26和图27所示的附接载体410’包括附接平台412’,该附接平台具有从其突起的附接杆414’。杆414’端接在尖顶端416’中,该尖卡口型顶端能够卡扣接合对应的附接卡扣腔体420’。本文所公开的各种形式的突起可一体地形成到附接载体410’的平台412’中,或者它们可通过适当的粘合剂附接到平台412’。在图27中,突起430为钩形的,并且极其适用于将具有上文所述的各种类型和组合物的组织压缩构件400保持钩挂到砧座100。例如,组织压缩构件400可包括泡沫或纤维氧化再生纤维素(ORC)材料。附接载体并非为植入式的并且与砧座100保持在一起以供再利用。附接特征410’被定位成使得突起区域150位于砧座100中的狭槽114的每侧并且使得它们不阻塞或妨碍钉成形凹坑104中的任何一个。一旦端部执行器12已被击发并且组织厚度补偿件400已被切割和缝合到靶组织,附接载体410就释放组织厚度补偿件400,而载体410’保持附接到砧座100。作为另外一种选择,载体410’可以类似的方式而非以紧固到砧座100的形式附接到钉仓120。
图28和图29示出了另选的实施例,其中两个突起区域150形成于对应的附接载体410”上,该对应的附接载体能够卡扣到形成于砧座100中的对应的附接腔体420”中。图28和图29所示的附接载体410”包括附接平台412”,该附接平台具有从其突起的附接杆414”。如图所示,杆414”具有基本上圆形的横截面形状,并且能够保持插入到对应的附接卡扣腔体420”中的对应的六边形孔422”中。作为另外一种选择,附接杆414”具有基本上六边形的横截面形状,并且孔422”为圆形的。本文所公开的各种形式的突起可一体地形成到附接载体410”的平台412”中,或者它们可通过适当的粘合剂附接到平台412”。在图29中,突起430为钩形的,并且极其适用于将具有上文所述的各种类型和组合物的组织压缩构件400保持钩挂到砧座100。例如,组织压缩构件400可包括泡沫或纤维氧化再生纤维素(ORC)材料。附接载体并非为植入式的并且与砧座100保持在一起以供再利用。附接特征410”被定位成使得突起区域150位于砧座100中的狭槽114的每侧并且使得它们不阻塞或妨碍钉成形凹坑104中的任何一个。一旦端部执行器12已被击发并且组织厚度补偿件400已被切割和缝合到靶组织,附接载体410”就释放组织厚度补偿件400,而载体410”保持附接到砧座100。作为另外一种选择,载体410”可以类似的方式而非以紧固到砧座100的形式附接到钉仓120。
图30和图31示出了在构造方面类似于上述砧座100的可供选择的砧座600。然而,该实施例采用形成于下表面602上的多个微纤维610。例如,微纤维由塑性材料或聚合物材料形成并且可通过适当的粘合剂附接到下侧面602,在另一种构造中,条带具有形成于其两个侧面上的微纤维610。微纤维可具有0.05至0.1英寸的近似长度,并且使用至少50根微纤维。例如,其上形成有微纤维610的条带构造(称为“壁虎条带”)可附接到位于纵向狭槽604每侧的区域中的砧座600的下表面602,使得它们不妨碍钉成形凹口606,如图30所示。多根微纤维610用于将组织厚度补偿件400可移除地附连到砧座600的下侧面602。微纤维610通过不可避免地被压缩到组织厚度补偿件400的表面中可不附接到组织厚度补偿件400,相反可需要平行于组织厚度补偿件400的表面的滑动运动来使纤维610弯曲并且附接。一旦端部执行器已被击发并且组织厚度补偿件400已被切割和缝合到靶组织,微纤维610就在砧座600从已缝合组织移除时从组织厚度补偿件400释放。作为另外一种选择,微纤维可从钉仓120的平台表面144突起。
图32和图33示出了在构造方面类似于上述砧座100的可供选择的砧座700。然而,该实施例使用钩形突起或纤维710的至少一个区域150,所述钩形突起或纤维能够可释放地接合组织厚度补偿件400。例如,四个区域150被定位成如图32所示。如在该图中可见,突起710可形成于条带构造上,该条带构造可粘附到砧座700的下侧面702。作为另外一种选择,区域150一体地形成于砧座200的下侧面702中。区域150可被定位在纵向狭槽704的每侧,使得它们不妨碍钉成形凹坑706。纤维710可具有0.05至0.1的近似长度,并且每个区域150可具有150-700的纤维密度。一旦端部执行器已被击发并且组织厚度补偿件400已被切割和缝合到靶组织,纤维710就在砧座700从已缝合组织移除时从组织厚度补偿件400释放。作为另外一种选择,区域150设置在钉仓120的平台144上。
图34和图35示出了在构造方面类似于上述砧座100的可供选择的砧座800。然而,该实施例使用突起810的至少一个区域150,该突起具有尖顶端812,该尖顶端能够刺穿到组织厚度补偿件400中并且将组织厚度补偿件400可释放地附接到砧座800的下侧面802。突起810具有基本上棱锥形状。作为另外一种选择,突起具有细长主体,该细长主体具有相对尖的末端以刺穿到组织厚度补偿件400中。例如,四个区域150被定位成如图34所示。如在该图中可见,突起810可形成于条带构造上,该条带构造可粘附到砧座800的下侧面802。作为另外一种选择,突起一体地形成于砧座800的下侧面802上。区域150可被定位在纵向狭槽804的每侧,使得它们不妨碍钉成形凹坑806。一旦端部执行器已被击发并且组织厚度补偿件400已被切割和缝合到靶组织,突起810就在砧座800从已缝合组织移除时从组织厚度补偿件400释放。作为另外一种选择,区域150设置在钉仓120的平台144上。
图36和图37示出了在构造方面类似于上述砧座100的可供选择的砧座900。然而,该实施例使用多个突起910,所述突起具有如图所示的基本上T形形状。突起910可形成于条带构造上,该条带构造可粘附到砧座900的下侧面902。作为另外一种选择,突起可一体地形成于砧座900的下侧面902上。突起能够可释放地接合组织厚度补偿件950,该组织厚度补偿件包括织造纤维氧化再生纤维素(ORC)或类似材料。一旦端部执行器已被击发并且组织厚度补偿件950已被切割和缝合到靶组织,突起910就在砧座900从已缝合组织移除时从组织厚度补偿件950释放。作为另外一种选择,区域150设置在钉仓120的平台144上。
图38到40示出了可供选择的组织厚度补偿件1000,该组织厚度补偿件能够可移除地附接到砧座100的下侧面102或钉仓120的平台表面144。在该实施例中,组织厚度补偿件可由上述各种可吸收聚合物泡沫制成。添加相异聚合物的固体元件,该固体元件将不被溶剂溶解,该溶剂为泡沫模具的芯。例如,可将PLA/PCL悬浮于叶绿素中,该叶绿素将不溶解任何PGA基材料。腔体由不溶性材料制成。在至少一个构造中,模具1010具有主体部分1012,该主体部分限定引入材料的腔体。模具1010还具有盖1014,该盖能够在组织厚度补偿件1000的上表面1002中形成一系列吸盘结构1004。为了将组织厚度补偿件1000可移除地附接到砧座100,将上表面1002按压成接合砧座100的下侧面102。吸盘结构1004用于将组织厚度补偿件1000可移除地附着到砧座100。作为另外一种选择,吸盘结构1004能够将组织厚度补偿件1000可移除地附着到外科钉仓120的平台142。
图41示出了端部执行器1112,该端部执行器具有钉仓1114、支撑在钉仓1114上的组织厚度补偿件1200、和砧座1120。名称为“Tissue ThicknessCompensator For a Surgical Stapler Comprising an Adjustable Anvil”的美国专利申请序列号13/097,891公开了此类端部执行器装置的实例,该专利申请全文此前以引用方式并入本文。图28使用了一对组织接合条带1300,所述组织接合条带附接到组织厚度补偿件1200的上表面1202。组织接合条带1300包括粘合剂条带,该粘合剂条带具有从其突起的组织接合突起1310。条带1300被定位在钉仓1114中的狭槽(未示出)的每侧,所述狭槽容纳组织切割构件(未示出)。条带1300可具有均匀分布在它们的整个长度中的突起1310,或者它们可被布置在分立区或区域1312中。例如,在图28中,突起1310在每个条带1300上布置在三个区域1312中。突起1310可包括本文所公开的突起构型中的任何一种。如图所示,例如,每个突起1310具有形成于它们的末端上的钩1314以接合被夹紧在砧座1120和组织厚度补偿件1200之间的组织。组织接合条带1300可包括例如以商品名“Velcro”销售的钩条带。条带1300可通过粘合剂、缝编、或其它合适的紧固构造附接到组织厚度补偿件1200。压缩时,突起1310接合夹紧的组织,以改善组织上的牵引力。
本文所公开的各种实施例和它们的相应的等同结构尤其适用于将纤维或泡沫组织厚度补偿件构造附接到外科缝合器械的一部分。例如,本为所公开的各种突起构造能够“机械地保持接合”组织厚度补偿件的结构以将组织厚度补偿件可移除地附接到外科缝合器械的一部分。如本文所用,术语“机械地保持接合”旨在涵盖对应的突起之间和/或突起与组织厚度补偿件之间的用于将组织厚度补偿件紧固到外科缝合器械,而不使用化学粘合剂来完成粘结的保持接合的形式。本文所公开的其它突起构造极其适用于保持接合由泡沫材料制成的组织厚度补偿件。这些构造可区别于以下那些外科缝合器构造,其中使用基本上平滑的、类似于聚脂薄膜的支撑物材料,并且其中使用化学粘合剂来在支撑物材料和缝合器械结构之间建立粘结。此外,尽管本文已参照某些实施例公开了附接突起区域,但在其它情况下,可使用仅一个附接突起,所述一个附接突起被配置并被成形用于机械地接合组织厚度补偿件的结构,以将组织厚度补偿件可移除地附着到外科缝合器械的一部分。例如,附接突起可包括端接在钩状结构中的突起,所述钩状结构极其适用于以钩的形式接合组织厚度补偿件的纤维或织造部分。
此外,应当理解,本文所公开的各种实施例可有效地结合多种不同的外科缝合器装置来进行使用。例如,除了附图所示的各种外科缝合装置之外,各种实施例可有效地结合开放式缝合器、线性缝合器、圆形缝合器等等来进行使用。这些缝合器可为手动控制的、马达控制的、和/或机器人控制的。此外,尽管本文已结合将组织厚度补偿材料附接到外科缝合装置的砧座或外科钉仓来描述了各种实施例,但各种实施例可用于将组织厚度补偿件附接到外科缝合器的其它部分。
对上文进行进一步描述,组织厚度补偿件可包含生物相容性材料。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中。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。表面活性剂实例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含至少一种药物。组织厚度补偿件可包含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含生物相容性泡沫,该生物相容性泡沫包括明胶、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含含有至少一种药物的膜。组织厚度补偿件可包含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可生物降解材料,以在可生物降解材料降解时提供所述至少一种药物的受控洗脱。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)中。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可由快速的初始洗脱速率和较慢的持续洗脱速率来表征。
根据本发明,组织厚度补偿件例如可包含生物相容性材料,该生物相容性材料可包括氧化剂。氧化剂可包括有机过氧化物和/或无机过氧化物。氧化剂的实例可包括但不限于过氧化氢、过氧化脲、过氧化钙、和过氧化镁、和过碳酸钠。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可由快速的初始洗脱速率和较慢的持续洗脱速率来表征。当氧化剂接触体液(例如,水)时,氧化剂可产生氧气。体液的实例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至约100nm和/或约10μm至约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,该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结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,该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,该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肖氏硬度A(30-50肖氏OO硬度)范围内的硬度计,其中最大刚度为15肖氏硬度A(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%和大于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中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,该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)、Certolizumab pegoll、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。在这种情况下,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、然后清洗或置换某些部分以及随后组装。特别是,所述装置可以拆卸,而且可以任意组合选择性地置换或移除该装置任意数目的特定零件或部分。清洗和/或置换特定部分后,该装置可以在修复设施处重新组装以便随后使用,或者在即将进行外科手术前由外科手术队重新组装。本领域的技术人员将会知道,装置的修复可利用多种用于拆卸、清洗/置换和重新组装的技术。这些技术的使用以及所得的修复装置均在本发明的范围内。
优选的是,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精神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 (22)
1.一种外科缝合器械,包括:
第一钳口,所述第一钳口在其中支撑多个外科钉,所述多个外科钉能够操作地响应于对其施加的击发动作;
第二钳口,所述第二钳口能够相对于所述第一钳口运动地支撑,使得在对所述第二钳口施加闭合动作时,所述第二钳口的一部分能够相对于所述第一钳口运动成面对关系;
组织厚度补偿件,所述组织厚度补偿件能够被捕获在所述外科钉内并且能够在对所述外科钉施加所述击发动作时在不同的外科钉内呈现不同的压缩高度;和
至少一个附接突起,所述至少一个附接突起位于所述第一钳口和第二钳口中的一个上以用于将所述组织厚度补偿件的对应部分可移除地机械附连到所述钳口。
2.根据权利要求1所述的外科缝合器械,其中所述组织厚度补偿件包括纤维主体结构,并且其中所述至少一个附接突起包括能够可移除地保持接合所述纤维主体结构的多个附接突起。
3.根据权利要求1或权利要求2所述的外科缝合器械,其中所述组织厚度补偿件包括由膜封装的可压缩主体,并且其中所述至少一个附接突起能够可移除地保持接合所述膜上的至少一个其它对应的其它附接突起。
4.根据前述权利要求中任一项所述的外科缝合器械,其中所述至少一个附接突起包括以下的至少一个区域:
具有棱锥形状的附接突起;
具有六边形形状的附接突起;
包括突起主体部分和与所述主体部分不共轴的远侧末端部分的附接突起;
包括大于其横截面积的高度的附接柱;
钩形附接突起;
环形突起;
T形突起;和
微纤维。
5.根据权利要求3所述的外科缝合器械,其中所述膜包括形成于其上的至少一个流体芯吸构件区域。
6.根据前述权利要求中任一项所述的外科缝合器械,其中所述组织厚度补偿件包括由织造材料制成的可压缩主体。
7.根据权利要求1-5中任一项所述的外科器械,其中所述组织厚度补偿件包括由非织造材料制成的可压缩主体。
8.根据前述权利要求中任一项所述的外科缝合器械,其中所述第一钳口包括限定平台表面的仓体,所述平台表面包括穿过所述平台表面的多个钉腔,并且其中所述多个外科钉被定位在所述钉腔内。
9.根据权利要求8所述的外科缝合器械,其中所述至少一个附接突起从所述平台表面突起。
10.根据权利要求8或权利要求9所述的外科缝合器械,其中所述至少一个附接突起一体地形成在所述平台表面上。
11.根据权利要求8-10中的任一项所述的外科缝合器械,其中所述组织厚度补偿件包括纤维主体结构,并且其中所述至少一个附接突起包括能够可移除地保持接合所述纤维主体结构的多个附接突起。
12.根据权利要求8-11中任一项所述的外科缝合器械,其中所述组织厚度补偿件包括由膜封装的可压缩主体,并且其中所述至少一个附接突起能够可移除地保持接合所述膜上的对应的至少一个其它附接突起。
13.根据权利要求8-12中任一项所述的外科缝合器械,其中所述仓体包括穿过所述平台表面形成的纵向延伸的平台狭槽,所述平台狭槽用于在其中接收组织切割构件的一部分,并且其中所述至少一个附接突起包括位于所述平台狭槽的一侧上的至少一个附接突起区域和位于所述平台狭槽的另一侧上的至少一个其它附接突起区域。
14.根据前述权利要求中任一项所述的外科缝合器械,其中所述第二钳口包括砧座,所述砧座在其上包括钉成形表面,并且其中所述至少一个附接突起从所述钉成形表面突起。
15.根据权利要求14所述的外科缝合器械,其中所述至少一个附接突起包括形成于对应的附接载体上的附接突起区域,所述对应的附接载体能够保持联接到所述砧座。
16.根据权利要求15所述的外科缝合器械,其中所述对应的附接载体中的每个能够卡扣地接合所述砧座。
17.根据权利要求15或权利要求16所述的外科缝合器械,其中所述附接突起区域通过粘合剂附接到所述对应的附接载体。
18.根据权利要求15或权利要求16所述的外科缝合器械,其中所述附接突起区域一体地形成在所述对应的附接载体上。
19.一种外科缝合器械,包括:
钉仓,所述钉仓包括:
仓体,所述仓体限定平台表面,所述平台表面具有穿过所述平台表面的多个钉腔;
多个钉,所述多个钉定位在所述钉腔内;
砧座,所述砧座在其上包括钉成形表面并且能够相对于所述钉仓运动地支撑,以响应于对所述砧座施加的闭合动作使所述钉成形表面相对于所述仓体的平台表面成面对关系;
组织厚度补偿件,所述组织厚度补偿件能够被捕获在所述钉内并且在不同的钉内呈现不同的压缩高度;和
至少一个附接突起区域,所述至少一个附接突起区域位于所述砧座的钉成形表面上以用于将所述组织厚度补偿件可移除地附接到所述钉成形表面。
20.一种外科缝合器械,包括:
钉仓,所述钉仓包括:
仓体,所述仓体限定平台表面,所述平台表面包括穿过所述平台表面的多个钉腔;
多个钉,所述多个钉定位在所述钉腔内;
砧座,所述砧座在其上包括钉成形表面并且能够相对于所述钉仓运动地支撑,以响应于对所述砧座施加的闭合动作使所述钉成形表面相对于所述仓体的平台表面成面对关系;
组织厚度补偿件,所述组织厚度补偿件能够被捕获在所述钉内并且在不同的钉内呈现不同的压缩高度;和
至少一个附接突起区域,所述至少一个附接突起区域位于所述平台表面上以用于将所述组织厚度补偿件可移除地附接到所述平台表面。
21.一种外科缝合器械,包括:
第一钳口,所述第一钳口在其中支撑多个外科钉,所述多个外科钉能够操作地响应于对其施加的击发动作;
第二钳口,所述第二钳口能够相对于所述第一钳口运动地支撑,使得在对所述第二钳口施加闭合动作时,所述第二钳口的一部分能够相对于所述第一钳口运动成面对关系;
组织厚度补偿件,所述组织厚度补偿件能够被捕获在所述外科钉内并且能够在对所述外科钉施加所述击发动作时在不同的外科钉内呈现不同的压缩高度,所述组织厚度补偿件能够在所述组织厚度补偿件与所述第一钳口和第二钳口中的一者之间建立抽吸保持力。
22.一种外科钉仓,包括:
仓体,所述仓体限定平台表面,所述平台表面包括穿过所述平台表面的多个钉腔;
多个钉,所述多个钉定位在所述钉腔内;和
至少一个附接突起区域,所述至少一个附接突起区域位于所述平台表面上以用于将组织厚度补偿件可移除地附接到所述平台表面。
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US13/433,132 US20130256373A1 (en) | 2012-03-28 | 2012-03-28 | Devices and methods for attaching tissue thickness compensating materials to surgical stapling instruments |
PCT/US2013/034104 WO2013148836A2 (en) | 2012-03-28 | 2013-03-27 | Devices and methods for attaching tissue thickness compensating materials to surgical stapling instruments |
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- 2013-03-27 WO PCT/US2013/034104 patent/WO2013148836A2/en active Application Filing
- 2013-03-27 MX MX2014011775A patent/MX2014011775A/es not_active Application Discontinuation
- 2013-03-27 JP JP2015503529A patent/JP2015513964A/ja active Pending
- 2013-03-27 RU RU2014143272A patent/RU2635319C2/ru not_active IP Right Cessation
- 2013-03-27 EP EP13161496.8A patent/EP2644126A3/en not_active Withdrawn
- 2013-03-27 BR BR112014024221-6A patent/BR112014024221B1/pt active IP Right Grant
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CN108024810A (zh) * | 2015-07-30 | 2018-05-11 | 伊西康有限责任公司 | 包括用于允许组织的任选横断的系统的外科器械 |
CN108135600A (zh) * | 2015-09-25 | 2018-06-08 | 伊西康有限责任公司 | 用于确定辅助件偏斜的植入式辅助件系统 |
CN108366797B (zh) * | 2015-09-30 | 2021-04-16 | 伊西康有限责任公司 | 具有附接层的可压缩附属物组件 |
CN108289673A (zh) * | 2015-09-30 | 2018-07-17 | 伊西康有限责任公司 | 具有互锁直立纤维的织造构造 |
CN108366797A (zh) * | 2015-09-30 | 2018-08-03 | 伊西康有限责任公司 | 具有附接层的可压缩附属物组件 |
CN109069154A (zh) * | 2016-05-06 | 2018-12-21 | 伊西康公司 | 外科缝合器/切割器和延伸支撑物 |
CN109069154B (zh) * | 2016-05-06 | 2022-01-18 | 伊西康公司 | 外科缝合器/切割器和延伸支撑物 |
CN110099629B (zh) * | 2016-12-21 | 2022-10-25 | 爱惜康有限责任公司 | 外科端部执行器及其适合的击发构件 |
CN110099629A (zh) * | 2016-12-21 | 2019-08-06 | 爱惜康有限责任公司 | 外科端部执行器及其适合的击发构件 |
CN110461250A (zh) * | 2017-02-17 | 2019-11-15 | 爱惜康有限责任公司 | 具有用于与附属物配合的延伸特征部的端部执行器 |
CN110461251A (zh) * | 2017-02-17 | 2019-11-15 | 爱惜康有限责任公司 | 用于将附属物联接到端部执行器的系统和方法 |
CN110402112A (zh) * | 2017-02-17 | 2019-11-01 | 爱惜康有限责任公司 | 将附属物抽吸附接到外科器械 |
CN110461251B (zh) * | 2017-02-17 | 2023-06-23 | 爱惜康有限责任公司 | 用于将附属物联接到端部执行器的系统和方法 |
CN110402112B (zh) * | 2017-02-17 | 2023-10-24 | 爱惜康有限责任公司 | 将附属物抽吸附接到外科器械 |
CN114403964A (zh) * | 2021-12-30 | 2022-04-29 | 苏州英途康医疗科技有限公司 | 一种缝合钉带和外科缝合器 |
CN114403964B (zh) * | 2021-12-30 | 2023-12-12 | 苏州英途康医疗科技有限公司 | 一种缝合钉带和外科缝合器 |
Also Published As
Publication number | Publication date |
---|---|
RU2635319C2 (ru) | 2017-11-10 |
US20130256373A1 (en) | 2013-10-03 |
JP2015513964A (ja) | 2015-05-18 |
RU2014143272A (ru) | 2016-05-20 |
BR112014024221A2 (zh) | 2017-06-20 |
CN104334093B (zh) | 2019-09-13 |
EP2644126A2 (en) | 2013-10-02 |
WO2013148836A2 (en) | 2013-10-03 |
BR112014024221B1 (pt) | 2022-09-27 |
WO2013148836A3 (en) | 2014-05-22 |
MX2014011775A (es) | 2015-03-05 |
EP2644126A3 (en) | 2014-02-19 |
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