CN108366796A - 包括收紧构型的可植入层 - Google Patents

包括收紧构型的可植入层 Download PDF

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Publication number
CN108366796A
CN108366796A CN201680069747.XA CN201680069747A CN108366796A CN 108366796 A CN108366796 A CN 108366796A CN 201680069747 A CN201680069747 A CN 201680069747A CN 108366796 A CN108366796 A CN 108366796A
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CN
China
Prior art keywords
layer
fiber
adjunct
compressible
nail
Prior art date
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Granted
Application number
CN201680069747.XA
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English (en)
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CN108366796B (zh
Inventor
J·L·哈里斯
F·E·谢尔顿四世
M·J·温德里
S·兰德格瑞贝
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Angiotech Pharmaceuticals Inc
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Angiotech Pharmaceuticals Inc
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Priority claimed from US14/871,057 external-priority patent/US20170086829A1/en
Application filed by Angiotech Pharmaceuticals Inc filed Critical Angiotech Pharmaceuticals Inc
Publication of CN108366796A publication Critical patent/CN108366796A/zh
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Abstract

本发明公开了一种包括仓体和可植入层的钉仓组件。所述可植入层包括由第一材料和第二材料构成的纤维。所述第一材料和所述第二材料具有不同的玻璃化转变温度。在由所述第一材料和所述第二材料构成的所述纤维已经相互混合或交织之后,将所述层暴露于超过所述两个玻璃化转变温度中较低温度的温度。所述加热过程导致所述层收紧并增加其厚度。所述层在植入时可以补偿所述钉内组织厚度的变化。

Description

包括收紧构型的可植入层
背景技术
本发明涉及外科器械,并且在各种布置中,涉及被设计成缝合和切割组织的外科缝合和切割器械及与其一起使用的钉仓。
附图说明
各种实施方案的特征在所附权利要求书中进行了详细描述。然而,通过结合如下附图参考以下说明可最好地理解关于操作的组织和方法的各种实施方案及其优点:
图1为包括柄部、从柄部延伸的轴以及延伸包括砧座和钉仓的端部执行器的外科缝合和切断器械的透视图;
图2为图1的外科缝合和切断器械的钉仓的楔形滑动件的透视图;
图3为图1的外科缝合和切断器械的二件式刀和击发杆(“E形梁”)的透视图;
图4为砧座、钉仓和可压缩附属物的纵向剖面图,该砧座处于闭合位置,该钉仓包括刚性支撑部分,并且该可压缩附属物被示为具有在击发序列期间从未击发位置移动到击发位置的钉;
图5为图4的砧座和钉仓的另一个剖面图,示出了在完成击发序列后处于打开位置的砧座;
图6为根据至少一个实施方案的可压缩附属物和钉仓的侧视图;
图7为包括钉仓和可压缩层的钉仓组件的横截面图,其中出于说明的目的已经移除了可压缩附属物的一部分;
图8为包括钉仓、可压缩层和粘合层的端部执行器的局部透视图,其中出于说明的目的已经移除了可压缩层的一部分;
图9为附接到外科器械的砧座的可压缩附属物组件的横截面图;
图10为附接到外科器械的砧座的可压缩附属物组件的横截面图;
图11为附接到外科器械的砧座的可压缩附属物组件的横截面图;
图12为与附接层组装在一起的砧座的局部透视图,其中出于说明的目的已经移除了砧座的一部分;
图13为图12的附接层的透视图;
图14为根据本文所公开的至少一个实施方案的夹在两个可压缩附属物组件之间的组织的局部透视图,其中使用外科缝合和切断器械来缝合和切割该组织;
图15为图14的组织和可压缩附属物组件的横截面图;
图16为包括中间节段的附接层的透视图,该中间节段具有从其中延伸出的杆;
图17为与包括附接层和可压缩层的可压缩附属物组件组装在一起的砧座的横截面图;
图18为根据本文所述的至少一个实施方案的包括可压缩层和两个附接构件的可压缩附属物组件的局部透视图;
图19为在可压缩附属物组件已被切割刃切断后,与图18的可压缩附属物组件组装在一起的砧座的剖视图;
图20为根据本文所述的至少一个实施方案的包括可压缩层和两个附接构件的可压缩附属物组件的局部透视图;
图21为根据本文所述的至少一个实施方案的包括可压缩层和两个附接构件的可压缩附属物组件的透视图;
图22为根据本文所述的至少一个实施方案的包括可压缩层和多个附接构件的可压缩附属物组件的局部透视图;
图23为与图22的可压缩附属物组件组装在一起的砧座的横截面图;
图24为图22的可压缩附属物组件的局部纵向剖面图;
图25为根据本文所述的至少一个实施方案的包括可压缩层和多个附接构件的可压缩附属物组件的局部透视图;
图26为根据本文所述的至少一个实施方案的附接到可压缩层的附接构件的局部纵向剖面图;
图27为根据本文所述的至少一个实施方案的附接到可压缩层的附接构件的局部纵向剖面图;
图28为根据本文所述的至少一个实施方案的附接到可压缩层的附接构件的局部纵向剖面图;
图29为根据本文所述的至少一个实施方案的与两个附接层组装在一起的砧座的局部透视图;
图30为图29的附接层的附接构件的透视图;
图31为图29的附接层的远侧部分的局部透视图;
图32为图29的附接层的远侧部分的另一个局部透视图;
图33为图29的附接层的局部纵向剖面图;
图34为图29的附接层的远侧部分的另一个局部透视图;
图35为根据至少一个实施方案的包括处于附接构型的可植入附属物的钉仓组件的局部剖视图;
图36为图35的钉仓组件的局部剖视图,其中可植入附属物处于脱离构型;
图37为包括钉仓、多个钉和可植入附属物的外科缝合组件的局部侧视图,其中外科缝合组件已被部分击发并且可植入附属物的一部分已与钉仓分离;
图38为图37的外科缝合组件的局部剖视图,示出了尚未从钉仓部署的钉;
图39为包括钉仓、多个带倒钩的钉和可植入附属物的外科缝合组件的局部侧视图,其中外科缝合组件已被部分击发并且可植入附属物的一部分已与钉仓分离;
图40为图39的外科缝合组件的局部剖视图,示出了尚未从钉仓部署的钉;
图41为根据至少一个实施方案的包括钉仓和至少部分地存在于钉仓内的可植入附属物的钉仓组件的局部透视图;
图42为根据至少一个实施方案的包括钉仓和可植入附属物的钉仓组件的局部端部透视图,该可植入附属物包括主体部分和多个附接部分;
图43为根据至少一个实施方案的击发组件的滑动件的透视图;
图44为包括图42的钉仓组件的外科缝合组件和包括图43的滑动件的击发组件的局部侧视图,该外科缝合组件包括钉仓和可植入附属物,其中外科缝合组件已被部分击发并且可植入附属物的一部分已从钉仓脱离;
图45为根据至少一个实施方案的包括平台保持特征结构的钉仓组件的局部端部透视图;
图46示出了用于将可植入附属物组装到钉仓上的方法的初始步骤;
图47示出了图46所示方法中的另一个步骤;
图48示出了图46和图47所示方法中的后续步骤;
图49为根据至少一个实施方案的包括可植入层的钉仓组件的细部图;
图50为贴靠患者组织植入的图49的层的细部图;
图51为根据至少一个实施方案的可植入层组件的透视图;
图52示出了包括相互缠绕的由第一材料构成的第一纤维和由第二材料构成的第二纤维的纤维组件;
图53示出了正暴露于热量的图52的纤维组件;
图54示出了在暴露于热量后处于收缩状态的图52的纤维组件;
图55为根据至少一个实施方案的可植入层的透视图;
图56为在暴露于热量后处于收缩状态的图55的层的透视图;
图57为根据至少一个实施方案的包括可植入层的钉仓组件的透视图;
图58为根据至少一个实施方案的包括具有不同的未成形高度的钉的钉仓组件的剖视图;
图59示出了形成为不同的成形高度的图58的钉;
图60示出了根据至少一个实施方案的多个扭结纤维;
图61为图60的扭结纤维的透视图;
图62为不包括扭结纤维的可植入层的局部透视图;
图63为根据至少一个实施方案的包括图60的扭结纤维的可植入层的局部透视图;
图64为根据至少一个实施方案的包括图60的扭结纤维的可植入层的透视图;
图65示出了用于形成图60的扭结纤维的过程;
图66示出了用于形成图60的扭结纤维的过程;
图67示出了用于形成图60的扭结纤维的过程;
图68为根据至少一个实施方案的包括相互交织的图60的扭结纤维和另一组纤维的可植入层的透视图;
图69为图68的可植入层的细部图;
图70为图68的可植入层的另一个细部图;
图71为根据至少一个实施方案的包括可植入层的钉仓组件的剖视图;
图72为图71的可植入层的剖视图;
图73为根据至少一个另选的实施方案的可植入层的剖视图;
图74为根据至少一个另选的实施方案的可植入层的剖视图;
图75为根据至少一个实施方案的可植入层的剖视图;
图76为图75的可植入层的剖视图;
图77为根据至少一个实施方案的可植入层的剖视图;
图78为根据至少一个实施方案的可植入层组件的透视图;
图79为图78的可植入层组件的分解图;
图80为根据至少一个实施方案的可植入层的局部剖视图;
图81为图80的可植入层的一部分的细部图;
图82为图78的可植入层组件的一部分的平面图;
图83示出了处于拉伸状态的图82的可植入层部分;
图84为图78的可植入层组件的一部分的平面图;
图85示出了处于拉伸状态的图84的可植入层部分;
图86为根据至少一个另选的实施方案的可植入层的平面图;
图87为根据至少一个另选的实施方案的可植入层的平面图;
图88为根据至少一个另选的实施方案的可植入层的平面图;
图89A至图89C示出了根据至少一个实施方案的用于在可植入层中形成开口的制造工艺;
图90为根据至少一个实施方案的可植入层的局部剖视图;
图91为根据至少一个实施方案的可植入层的局部透视图;
图92为图91的可植入层的局部剖视图;
图93为包括多个纤维管状构件的部分组装的可压缩附属物组件的透视图;
图94为根据本文所述的至少一个实施方案来组装和热处理的图93的可压缩附属物组件的局部透视图;
图95为根据本文所述的至少一个实施方案的可压缩附属物组件插入加热模具中的局部透视图;
图96为根据本文所述的至少一个实施方案的图95的可压缩附属物组件经受热压处理的剖视图;
图97为图95的可压缩附属物组件在完成热压处理之后以及在从模具移除之后的局部透视图;
图98为根据本文所述的至少一个实施方案的与钉仓组件组装在一起的可压缩附属物组件的透视图;
图99为图98的可压缩附属物组件的前视图,其中出于说明的目的已经移除了可压缩附属物组件的一部分;
图100为图99的可压缩附属物组件的内部部分的特写视图;
图101为根据本文所述的至少一个实施方案的多个第一纤维和多个第二纤维的图示,其中多个第二纤维熔融并重新固化;
图102为根据本文所述的至少一个实施方案的可压缩附属物组件的图示;
图103为根据本文所述的至少一个实施方案的图102的可压缩附属物组件经受热压处理的剖视图;
图104为可压缩附属物组件的局部剖视图,其中出于说明的目的已经移除了可压缩附属物组件的一部分;
图105为根据本文所述的至少一个实施方案的可压缩附属物组件的局部剖视图;
图106为根据本文所述的至少一个实施方案的可压缩附属物组件的局部剖视图;以及
图107为根据本文所述的至少一个实施方案的可压缩附属物组件的局部剖视图。
在所述若干视图中,对应的参考符号指示对应的部件。本文所述的范例以一种形式示出了本发明的各种实施方案,且这种范例不应被解释为以任何方式限制本发明的范围。
具体实施方式
本申请的申请人拥有以下美国专利申请,所述美国专利申请与本申请于同一日期提交且各自全文以引用方式并入本文:
名称为“IMPLANTABLE LAYER COMPRISING PLASTICALLY DEFORMED FIBERS”的美国专利申请序列号__________;代理人案卷号END7646USNP/150081;
名称为“TUBULAR ABSORBABLE CONSTRUCTS”的美国专利申请序列号__________;代理人案卷号END7648USNP/150083;
名称为“IMPLANTABLE ADJUNCT COMPRISING BONDED LAYERS”的美国专利申请序列号__________;代理人案卷号END7649USNP/150084;
名称为“COMPRESSIBLE ADJUNCTS WITH BONDING NODES”的美国专利申请序列号__________;代理人案卷号END7650USNP/150085;
名称为“COMPRESSIBLE ADJUNCT WITH INTERMEDIATE SUPPORTING STRUCTURES”的美国专利申请序列号__________;代理人案卷号END7651USNP/150086;
名称为“COMPRESSIBLE ADJUNCT WITH CROSSING SPACER FIBERS”的美国专利申请序列号__________;代理人案卷号END7652USNP/150087;
名称为“COMPRESSIBLE ADJUNCT WITH LOOPING MEMBERS”的美国专利申请序列号__________;代理人案卷号END7653USNP/150088;
名称为“WOVEN CONSTRUCTS WITH INTERLOCKED STANDING FIBERS”的美国专利申请序列号__________;代理人案卷号END7654USNP/150089;
名称为“COMPRESSIBLE ADJUNCT AND METHODS FOR MAKING THE SAME”的美国专利申请序列号__________;代理人案卷号END7655USNP/150090;
名称为“METHOD FOR APPLYING AN IMPLANTABLE LAYER TO A FASTENERCARTRIDGE”的美国专利申请序列号__________;代理人案卷号END7656USNP/150091;
名称为“COMPRESSIBLE ADJUNCT WITH ATTACHMENT REGIONS”的美国专利申请序列号__________;代理人案卷号END7657USNP/150092;
名称为“PROGRESSIVELY RELEASABLE IMPLANTABLE ADJUNCT FOR USE WITH ASURGICAL STAPLING INSTRUMENT”的美国专利申请序列号__________;代理人案卷号END7658USNP/150093;以及
名称为“COMPRESSIBLE ADJUNCT ASSEMBLIES WITH ATTACHMENT LAYERS”的美国专利申请序列号__________;代理人案卷号END7659USNP/150094。
本申请的申请人还拥有在下文中标识的美国专利申请,这些美国专利申请各自全文以引用方式并入本文:
名称为“SURGICAL INSTRUMENTS WITH RECONFIGURABLE SHAFT SEGMENTS”的美国专利申请序列号12/894,311;现为美国专利号8,763,877;
名称为“SURGICAL STAPLE CARTRIDGES SUPPORTING NON-LINEARLY ARRANGEDSTAPLES AND SURGICAL STAPLING INSTRUMENTS WITH COMMON STAPLE-FORMING POCKETS”的美国专利申请序列号12/894,340;现为美国专利号8,899,463;
名称为“JAW CLOSURE ARRANGEMENTS FOR SURGICAL INSTRUMENTS”的美国专利申请序列号12/894,327;现为美国专利号8,978,956;
名称为“SURGICAL CUTTING AND FASTENING INSTRUMENTS WITH SEPARATE ANDDISTINCT FASTENER DEPLOYMENT AND TISSUE CUTTING SYSTEMS”的美国专利申请序列号12/894,351;现为美国专利号9,113,864;
名称为“IMPLANTABLE FASTENER CARTRIDGE HAVING A NON-UNIFORMARRANGEMENT”的美国专利申请序列号12/894,338;现为美国专利号8,864,007;
名称为“IMPLANTABLE FASTENER CARTRIDGE COMPRISING A SUPPORT RETAINER”的美国专利申请序列号12/894,369;现为美国专利申请公布2012/0080344;
名称为“IMPLANTABLE FASTENER CARTRIDGE COMPRISING MULTIPLE LAYERS”的美国专利申请序列号12/894,312;现为美国专利号8,925,782;
名称为“SELECTIVELY ORIENTABLE IMPLANTABLE FASTENER CARTRIDGE”的美国专利申请序列号12/894,377;现为美国专利号8,393,514;
名称为“SURGICAL STAPLING INSTRUMENT WITH COMPACT ARTICULATION CONTROLARRANGEMENT”的美国专利申请序列号12/894,339;现为美国专利号8,840,003;
名称为“SURGICAL STAPLING INSTRUMENT WITH A VARIABLE STAPLE FORMINGSYSTEM”的美国专利申请序列号12/894,360;现为美国专利号9,113,862;
名称为“SURGICAL STAPLING INSTRUMENT WITH INTERCHANGEABLE STAPLECARTRIDGE ARRANGEMENTS”的美国专利申请序列号12/894,322;现为美国专利号8,740,034;
名称为“SURGICAL STAPLE CARTRIDGES WITH DETACHABLE SUPPORT STRUCTURES”的美国专利申请序列号12/894,350;现为美国专利申请公布2012/0080478;
名称为“IMPLANTABLE FASTENER CARTRIDGE COMPRISING BIOABSORBABLELAYERS”的美国专利申请序列号12/894,383;现为美国专利号8,752,699;
名称为“COMPRESSIBLE FASTENER CARTRIDGE”的美国专利申请序列号12/894,389;现为美国专利号8,740,037;
名称为“FASTENERS SUPPORTED BY A FASTENER CARTRIDGE SUPPORT”的美国专利申请序列号12/894,345;现为美国专利号8,783,542;
名称为“COLLAPSIBLE FASTENER CARTRIDGE”的美国专利申请序列号12/894,306;现为美国专利号9,044,227;
名称为“FASTENER SYSTEM COMPRISING A PLURALITY OF CONNECTED RETENTIONMATRIX ELEMENTS”的美国专利申请序列号12/894,318;现为美国专利号8,814,024;
名称为“FASTENER SYSTEM COMPRISING A RETENTION MATRIX AND AN ALIGNMENTMATRIX”的美国专利申请序列号12/894,330;现为美国专利号8,757,465;
名称为“FASTENER SYSTEM COMPRISING A RETENTION MATRIX”的美国专利申请序列号12/894,361;现为美国专利号8,529,600;
名称为“FASTENING INSTRUMENT FOR DEPLOYING A FASTENER SYSTEMCOMPRISING A RETENTION MATRIX”的美国专利申请序列号12/894,367;现为美国专利号9,033,203;
名称为“FASTENER SYSTEM COMPRISING A RETENTION MATRIX AND A COVER”的美国专利申请序列号12/894,388;现为美国专利号8,474,677;
名称为“FASTENER SYSTEM COMPRISING A PLURALITY OF FASTENER CARTRIDGES”的美国专利申请序列号12/894,376;现为美国专利号9,044,228;
名称为“SURGICAL STAPLER ANVIL COMPRISING A PLURALITY OF FORMINGPOCKETS”的美国专利申请序列号13/097,865;现为美国专利申请公布2012/0080488;
名称为“TISSUE THICKNESS COMPENSATOR FOR A SURGICAL STAPLER”的美国专利申请序列号13/097,936;现为美国专利号8,657,176;
名称为“STAPLE CARTRIDGE COMPRISING A VARIABLE THICKNESS COMPRESSIBLEPORTION”的美国专利申请序列号13/097,954;现为美国专利申请公布2012/0080340;
名称为“STAPLE CARTRIDGE COMPRISING STAPLES POSITIONED WITHIN ACOMPRESSIBLE PORTION THEREOF”的美国专利申请序列号13/097,856;现为美国专利申请公布2012/0080336;
名称为“TISSUE THICKNESS COMPENSATOR COMPRISING DETACHABLE PORTIONS”的美国专利申请序列号13/097,928;现为美国专利号8,746,535;
名称为“TISSUE THICKNESS COMPENSATOR FOR A SURGICAL STAPLER COMPRISINGAN ADJUSTABLE ANVIL”的美国专利申请序列号13/097,891;现为美国专利号8,864,009;
名称为“STAPLE CARTRIDGE COMPRISING AN ADJUSTABLE DISTAL PORTION”的美国专利申请序列号13/097,948;现为美国专利号8,978,954;
名称为“OMPRESSIBLE STAPLE CARTRIDGE ASSEMBLY”美国专利申请序列号13/097,907;现为美国专利申请公布2012/0080338;
名称为“TISSUE THICKNESS COMPENSATOR COMPRISING PORTIONS HAVINGDIFFERENT PROPERTIES”的美国专利申请序列号13/097,861;现为美国专利号9,113,865;
名称为“STAPLE CARTRIDGE LOADING ASSEMBLY”的美国专利申请序列号13/097,869;现为美国专利号8,857,694;
名称为“COMPRESSIBLE STAPLE CARTRIDGE COMPRISING ALIGNMENT MEMBERS”的美国专利申请序列号13/097,917;现为美国专利号8,777,004;
名称为“STAPLE CARTRIDGE COMPRISING A RELEASABLE PORTION”的美国专利申请序列号13/097,873;现为美国专利号8,740,038;
名称为“STAPLE CARTRIDGE COMPRISING COMPRESSIBLE DISTORTION RESISTANTCOMPONENTS”的美国专利申请序列号13/097,938;现为美国专利号9,016,542;
名称为“STAPLE CARTRIDGE COMPRISING A TISSUE THICKNESS COMPENSATOR”的美国专利申请序列号13/097,924;现为美国专利申请公布2012/0083835;
名称为“SURGICAL STAPLER WITH FLOATING ANVIL”的美国专利申请序列号13/242,029;现为美国专利号8,893,949;
名称为“CURVED END EFFECTOR FOR A STAPLING INSTRUMENT”的美国专利申请序列号13/242,066;现为美国专利申请公布2012/0080498;
名称为“STAPLE CARTRIDGE INCLUDING COLLAPSIBLE DECK”的美国专利申请序列号13/242,086;现为美国专利号9,055,941;
名称为“STAPLE CARTRIDGE INCLUDING COLLAPSIBLE DECK ARRANGEMENT”的美国专利申请序列号13/241,912;现为美国专利号9,050,084;
名称为“SURGICAL STAPLER WITH STATIONARY STAPLE DRIVERS”的美国专利申请序列号13/241,922;现为美国专利申请公布2013/0075449;
名称为“SURGICAL INSTRUMENT WITH TRIGGER ASSEMBLY FOR GENERATINGMULTIPLE ACTUATION MOTIONS”的美国专利申请序列号13/241,637;现为美国专利号8,789,741;
名称为“SURGICAL INSTRUMENT WITH SELECTIVELY ARTICULATABLE ENDEFFECTOR”的美国专利申请序列号13/241,629;现为美国专利申请公布2012/0074200;
名称为“TISSUE THICKNESS COMPENSATOR COMPRISING A PLURALITY OFCAPSULES”的美国专利申请序列号13/433,096;现为美国专利申请公布2012/0241496;
名称为“TISSUE THICKNESS COMPENSATOR COMPRISING A PLURALITY OF LAYERS”的美国专利申请序列号13/433,103;现为美国专利申请公布2012/0241498;
名称为“EXPANDABLE TISSUE THICKNESS COMPENSATOR”的美国专利申请序列号13/433,098;现为美国专利申请公布2012/0241491;
名称为“TISSUE THICKNESS COMPENSATOR COMPRISING A RESERVOIR”的美国专利申请序列号13/433,102;现为美国专利申请公布2012/0241497;
名称为“RETAINER ASSEMBLY INCLUDING A TISSUE THICKNESS COMPENSATOR”的美国专利申请序列号13/433,114;现为美国专利申请公布2012/0241499;
名称为“TISSUE THICKNESS COMPENSATOR COMPRISING AT LEAST ONEMEDICAMENT”的美国专利申请序列号13/433,136;现为美国专利申请公布2012/0241492;
名称为“TISSUE THICKNESS COMPENSATOR COMPRISING CONTROLLED RELEASE ANDEXPANSION”的美国专利申请序列号13/433,141;现为美国专利申请公布2012/0241493;
名称为“TISSUE THICKNESS COMPENSATOR COMPRISING FIBERS TO PRODUCE ARESILIENT LOAD”的美国专利申请序列号13/433,144;现为美国专利申请公布2012/0241500;
名称为“TISSUE THICKNESS COMPENSATOR COMPRISING STRUCTURE TO PRODUCE ARESILIENT LOAD”的美国专利申请序列号13/433,148;现为美国专利申请公布2012/0241501;
名称为“TISSUE THICKNESS COMPENSATOR COMPRISING RESILIENT MEMBERS”的美国专利申请序列号13/433,155;现为美国专利申请公布2012/0241502;
名称为“METHODS FOR FORMING TISSUE THICKNESS COMPENSATOR ARRANGEMENTSFOR SURGICAL STAPLERS”的美国专利申请序列号13/433,163;现为美国专利申请公布2012/0248169;
名称为“TISSUE THICKNESS COMPENSATORS”的美国专利申请序列号13/433,167;现为美国专利申请公布2012/0241503;
名称为“LAYERED TISSUE THICKNESS COMPENSATOR”的美国专利申请序列号13/433,175;现为美国专利申请公布2012/0253298;
名称为“TISSUE THICKNESS COMPENSATORS FOR CIRCULAR SURGICAL STAPLERS”的美国专利申请序列号13/433,179;现为美国专利申请公布2012/0241505;
名称为“ADHESIVE FILM LAMINATE”的美国专利申请序列号13/763,028;现为美国专利申请公布2013/0146643;
名称为“TISSUE THICKNESS COMPENSATOR COMPRISING CAPSULES DEFINING ALOW PRESSURE ENVIRONMENT”的美国专利申请序列号13/433,115;现为美国专利申请公布2013/0256372;
名称为“TISSUE THICKNESS COMPENSATOR COMPRISED OF A PLURALITY OFMATERIALS”的美国专利申请序列号13/433,118;现为美国专利申请公布2013/0256365;
名称为“MOVABLE MEMBER FOR USE WITH A TISSUE THICKNESS COMPENSATOR”的美国专利申请序列号13/433,135;现为美国专利申请公布2013/0256382;
名称为“TISSUE THICKNESS COMPENSATOR AND METHOD FOR MAKING THE SAME”的美国专利申请序列号13/433,140;现为美国专利申请公布2013/0256368;
名称为“TISSUE THICKNESS COMPENSATOR COMPRISING A PLURALITY OFMEDICAMENTS”的美国专利申请序列号13/433,129;现为美国专利申请公布2013/0256367;
名称为“STAPLE CARTRIDGES FOR FORMING STAPLES HAVING DIFFERING FORMEDSTAPLE 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 HAVING STAPLE FORMINGPOCKETS OF VARYING DEPTHS”的美国专利申请序列号11/714,049;现为美国专利申请公布2007/0194082;
名称为“SURGICAL STAPLING DEVICES THAT PRODUCE FORMED STAPLES HAVINGDIFFERENT 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 OF DIFFERENTHEIGHT”的美国专利申请序列号11/711,975;现为美国专利申请公布2007/0194079;
名称为“SURGICAL STAPLING DEVICE WITH STAPLE DRIVER THAT SUPPORTSMULTIPLE 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 STACKED ACTUATOR WEDGECAMS 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 HAVING DIFFERING FORMEDSTAPLE 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 PRODUCE FORMED STAPLES HAVINGDIFFERENT LENGTHS”的美国专利申请序列号13/020,263,现为美国专利号8,636,187;
名称为“ROBOTICALLY-CONTROLLED SURGICAL STAPLING DEVICES THAT PRODUCEFORMED STAPLES HAVING DIFFERENT LENGTHS”的美国专利申请序列号13/118,278;现为美国专利申请公布2011/0290851;
名称为“ROBOTICALLY-CONTROLLED CABLE-BASED SURGICAL END EFFECTORS”的美国专利申请序列号13/369,629,现为美国专利号8,800,838;
名称为“SURGICAL STAPLING DEVICES FOR FORMING STAPLES WITH DIFFERENTFORMED HEIGHTS”的美国专利申请序列号12/695,359;现为美国专利8,464,923;
名称为“STAPLE CARTRIDGES FOR FORMING STAPLES HAVING DIFFERING FORMEDSTAPLE HEIGHTS”的美国专利申请序列号13/072,923,现为美国专利8,567,656;
名称为“LAYER OF MATERIAL FOR A SURGICAL END EFFECTOR”的美国专利申请序列号13/766,325;现为美国专利申请公布2013/0256380;
名称为“ANVIL LAYER ATTACHED TO A PROXIMAL END OF AN END EFFECTOR”的美国专利申请序列号13/763,078;现为美国专利申请公布2013/0256383;
名称为“LAYER COMPRISING DEPLOYABLE ATTACHMENT MEMBERS”的美国专利申请序列号13/763,094;现为美国专利申请公布2013/0256377;
名称为“END EFFECTOR COMPRISING A DISTAL TISSUE ABUTMENT MEMBER”美国专利申请序列号13/763,106;现为美国专利申请公布2013/0256378;
名称为“TISSUE THICKNESS COMPENSATOR COMPRISING CHANNELS”的美国专利申请序列号13/433,147;现为美国专利申请公布2013/0256369;
名称为“SURGICAL STAPLING CARTRIDGE WITH LAYER RETENTION FEATURES”的美国专利申请序列号13/763,112;现为美国专利申请公布2013/0256379;
名称为“ACTUATOR FOR RELEASING A TISSUE THICKNESS COMPENSATOR FROM AFASTENER CARTRIDGE”的美国专利申请序列13/763,035;现为美国专利申请公布2013/0214030;
名称为“RELEASABLE TISSUE THICKNESS COMPENSATOR AND FASTENER CARTRIDGEHAVING THE SAME”的美国专利申请序列号13/763,042;现为美国专利申请公布2013/0221063;
名称为“FASTENER CARTRIDGE COMPRISING A RELEASABLE TISSUE THICKNESSCOMPENSATOR”的美国专利申请序列号13/763,048;现为美国专利申请公布2013/0221064;
名称为“FASTENER CARTRIDGE COMPRISING A CUTTING MEMBER FOR RELEASING ATISSUE THICKNESS COMPENSATOR”的美国专利申请序列号13/763,054;现为美国专利申请公布2014/0097227;
名称为“FASTENER CARTRIDGE COMPRISING A RELEASABLY ATTACHED TISSUETHICKNESS COMPENSATOR”的美国专利申请序列号13/763,065;现为美国专利申请公布2013/0221065;
名称为“STAPLE CARTRIDGE COMPRISING A RELEASABLE COVER”的美国专利申请序列号13/763,021;现为美国专利申请公布2014/0224686;
名称为“ANVIL LAYER ATTACHED TO A PROXIMAL END OF AN END EFFECTOR”的美国专利申请序列号13/763,078;现为美国专利申请公布2013/0256383;
名称为“LAYER ARRANGEMENTS FOR SURGICAL STAPLE CARTRIDGES”的美国专利申请序列号13/763,095;现为美国专利申请公布2013/0161374;
名称为“IMPLANTABLE ARRANGEMENTS FOR SURGICAL STAPLE CARTRIDGES”的美国专利申请序列号13/763,147;现为美国专利申请公布2013/0153636;
名称为“MULTIPLE THICKNESS IMPLANTABLE LAYERS FOR SURGICAL STAPLINGDEVICES”的美国专利申请序列号13/763,192;现为美国专利申请公布2013/0146642;
名称为“RELEASABLE LAYER OF MATERIAL AND SURGICAL END EFFECTOR HAVINGTHE SAME”的美国专利申请序列号13/763,161;现为美国专利申请公布2013/0153641;
名称为“ACTUATOR FOR RELEASING A LAYER OF MATERIAL FROM A SURGICAL ENDEFFECTOR”的美国专利申请序列号13/763,177;现为美国专利申请公布2013/0146641;
名称为“STAPLE CARTRIDGE COMPRISING A COMPRESSIBLE PORTION”的美国专利申请序列号13/763,037;现为美国专利申请公布2014/0224857;
名称为“TISSUE THICKNESS COMPENSATOR COMPRISING TISSUE INGROWTHFEATURES”的美国专利申请序列号13/433,126;现为美国专利申请公布2013/0256366;
名称为“DEVICES AND METHODS FOR ATTACHING TISSUE THICKNESSCOMPENSATING MATERIALS TO SURGICAL STAPLING INSTRUMENTS”的美国专利申请序列号13/433,132;现为美国专利申请公布2013/0256373;
名称为“FASTENER CARTRIDGE COMPRISING A TISSUE THICKNESS COMPENSATORINCLUDING OPENINGS THEREIN”的美国专利申请序列号13/851,703;现为美国专利申请公布2014/0291382;
名称为“TISSUE THICKNESS COMPENSATOR COMPRISING A CUTTING MEMBER PATH”的美国专利申请序列号13/851,676;现为美国专利申请公布2014/0291379;
名称为“FASTENER CARTRIDGE ASSEMBLIES”的美国专利申请序列号13/851,693;现为美国专利申请公布2014/0291381;
名称为“FASTENER CARTRIDGE COMPRISING A TISSUE THICKNESS COMPENSATORAND A GAP SETTING ELEMENT”的美国专利申请序列号13/851,684;现为美国专利申请公布2014/0291380;
名称为“STAPLE CARTRIDGE INCLUDING A BARBED STAPLE”的美国专利申请序列号14/187,387,现为美国专利申请公布2014/0166724;
名称为“STAPLE CARTRIDGE INCLUDING A BARBED STAPLE”的美国专利申请序列号14/187,395,现为美国专利申请公布2014/0166725;
名称为“STAPLE CARTRIDGE INCLUDING A BARBED STAPLE”的美国专利申请序列号14/187,400,现为美国专利申请公布2014/0166726;
名称为“IMPLANTABLE LAYERS AND METHODS FOR ALTERING IMPLANTABLE LAYERSFOR USE WITH SURGICAL FASTENING INSTRUMENTS”的美国专利申请序列号14/187,383,现为美国专利申请公布2015/0238185;
名称为“IMPLANTABLE LAYERS AND METHODS FOR ALTERING ONE OR MOREPROPERTIES OF IMPLANTABLE LAYERS FOR USE WITH FASTENING INSTRUMENTS”的美国专利申请序列号14/187,386,现为美国专利申请公布2015/0239180;
名称为“IMPLANTABLE LAYERS AND METHODS FOR MODIFYING THE SHAPE OF THEIMPLANTABLE LAYERS FOR USE WITH A SURGICAL FASTENING INSTRUMENT”的美国专利申请序列号14/187,390,现为美国专利申请公布2015/0238188;
名称为“IMPLANTABLE LAYER ASSEMBLIES”的美国专利申请序列号14/187,389,现为美国专利申请公布2015/0238187;
名称为“IMPLANTABLE LAYERS COMPRISING A PRESSED REGION”的美国专利申请序列号14/187,385,现为美国专利申请公布2015/0238191;
名称为“FASTENING SYSTEM COMPRISING A FIRING MEMBER LOCKOUT”的美国专利申请序列号14/187,384,现为美国专利申请公布2015/0238186;
名称为“IMPLANTABLE LAYERS FOR A SURGICAL INSTRUMENT”的美国专利申请序列号14/827,856;
名称为“IMPLANTABLE LAYERS FOR A SURGICAL INSTRUMENT”的美国专利申请序列号14/827,907;
名称为“IMPLANTABLE LAYERS FOR A SURGICAL INSTRUMENT”的美国专利申请序列号14/827,932;
名称为“MALLEABLE BIOABSORBABLE POLYMER ADHESIVE FOR RELEASABLYATTACHING A STAPLE BUTTRESS TO A SURGICAL STAPLER”的美国专利申请序列号14/667,874;
名称为“ADJUNCT MATERIALS AND METHODS OF USING SAME IN SURGICALMETHODS FOR TISSUE SEALING”的美国专利申请序列号14/300,954;
名称为“DRUG ELUTING ADJUNCTS AND METHODS OF USING DRUG ELUTINGADJUNCTS”的美国专利申请序列号14/840,613;
名称为“METHOD FOR CREATING A FLEXIBLE STAPLE LINE”的美国专利申请序列号14/498,145;以及
名称为“IMPLANTABLE ADJUNCT SYSTEMS FOR DETERMINING ADJUNCT SKEW”的美国专利申请序列号14/865,306。
本文列出了许多具体细节,以提供对说明书中所述和附图中所示的实施方案的整体结构、功能、制造和用途的透彻理解。没有详细描述熟知的操作、部件和元件,以免使说明书中描述的实施方案模糊不清。读者将会理解,本文所述和所示的实施方案为非限制性示例,从而可认识到,本文所公开的特定结构和功能细节可为代表性和例示性的。在不脱离权利要求的范围的情况下,可对这些实施方案进行变型和改变。
术语“包括”、“具有”、“包含”、以及“含有”为开放式系动词。因此,“包括”、“具有”、“包含”或“含有”一个或多个元件的外科系统、装置、或设备具有这些一个或多个元件,但不限于仅具有这些一个或多个元件。同样,“包括”、“具有”、“包含”或“含有”一个或多个特征的系统、装置、或设备的元件具有那些一个或多个特征,但不限于仅具有那些一个或多个特征。
术语“近侧”和“远侧”在本文中是相对于操纵外科器械的柄部部分的临床医生来使用的。术语“近侧”是指最靠近临床医生的部分,并且术语“远侧”是指远离临床医生定位的部分。还应当理解,为简洁和清楚起见,本文可结合附图使用诸如“竖直”、“水平”、“上”和“下”等空间术语。然而,外科器械在许多方向和位置中使用,并且这些术语并非限制性的和/或绝对的。
提供各种示例性装置和方法以用于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,包括例如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能够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直接插入患者体内或者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。
外科缝合系统可包括轴和从轴延伸的端部执行器。端部执行器包括第一钳口和第二钳口。第一钳口包括钉仓。钉仓能够插入到第一钳口中并且能够从第一钳口移除;然而,设想到其中钉仓不能够从第一钳口移除或至少能够易于从第一钳口替换的其他实施方案。第二钳口包括被构造成能够使从钉仓射出的钉变形的砧座。第二钳口能够相对于第一钳口围绕闭合轴线枢转;然而,可设想到其中第一钳口能够相对于第二钳口枢转的其他实施方案。外科缝合系统还包括被构造成能够允许端部执行器相对于轴旋转或进行关节运动的关节运动接头。端部执行器能够围绕延伸穿过关节运动接头的关节运动轴线旋转。设想了不包括关节运动接头的其它实施方案。
钉仓包括仓体。仓体包括近侧端部、远侧端部和在近侧端部与远侧端部之间延伸的平台。在使用中,钉仓定位在待缝合的组织的第一侧上,并且砧座定位在组织的第二侧上。砧座朝向钉仓运动以将组织压缩并夹持抵靠平台。然后,可移除地储存在仓体中的钉可部署到组织中。仓体包括限定于其中的钉腔,其中钉可移除地储存在钉腔中。钉腔被布置成六纵向排。三排钉腔定位在纵向狭槽的第一侧上且三排钉腔定位在纵向狭槽的第二侧上。钉腔和钉的其它布置方式也是可以的。
钉由仓体中的钉驱动器支撑。驱动器能够在第一或非击发位置和第二或击发位置之间运动,以从钉仓射出钉。驱动器通过保持器保留在仓体中,保持器围绕仓体的底部延伸并且包括被构造成能够抓持仓体以及将保持器保持至仓体的弹性构件。驱动器能够通过滑动件在其非击发位置和击发位置之间运动。滑动件能够在与近侧端部相邻的近侧位置和与远侧端部相邻的远侧位置之间运动。滑动件包括多个斜坡表面,该斜坡表面被构造成能够朝向砧座在驱动器下方滑动以及提升驱动器,并且钉在驱动器上受到支撑。
除上述以外,滑动件还可通过击发构件朝远侧运动。击发构件被构造成能够接触滑动件并朝向远侧端部推动滑动件。限定于仓体中的纵向狭槽被构造成能够接收击发构件。砧座还包括被构造成能够接收击发构件的狭槽。击发构件还包括接合第一钳口的第一凸轮和接合第二钳口的第二凸轮。在击发构件朝远侧推进时,第一凸轮和第二凸轮可控制钉仓的平台和砧座之间的距离或组织间隙。击发构件还包括被构造成能够切入在钉仓和砧座中间捕集的组织的刀。希望刀定位成至少部分接近斜坡表面,使得钉先于刀被射出。
钉仓还可包括植入式层。植入式层被构造成能够在钉被相应的驱动器部署时连同组织被捕获在钉内。植入式层可包括支撑物、组织厚度补偿件、和/或其他助剂材料。组织厚度补偿件被构造成能够补偿组织特性的变化,诸如组织厚度例如沿钉线的变化。组织厚度补偿件可为可压缩的和弹性的。在使用中,组织厚度补偿件防止或限制缝合组织的过度压缩,同时有利于钉内和钉间的充分组织压缩。
钉仓的植入式层可以可剥离方式固定到钉仓的主体。例如,植入式层可利用可剥离粘合剂、至少一个附接插片、和/或其他附接特征结构以可剥离方式固定到钉仓的平台。除此之外或另选地,植入式层可以可剥离方式固定到第一钳口或第二钳口。植入式层可被定位到例如端部执行器的仓侧和/或端部执行器的砧座侧上。
植入式层可被构造成能够促进组织向内生长。在各种情况下,希望促进组织在植入式层中的向内生长以促进被处理组织(例如,缝合组织和/或切入组织)的愈合并且/或者加速患者的恢复。更具体地,组织在植入式层中的向内生长可降低外科部位处的炎症的发生率、范围和/或持续时间。组织在植入式层中和/或周围的向内生长可控制例如外科部位处的感染的扩散。血管尤其是白血细胞例如在植入式层中和/或周围的向内生长可抵抗植入式层及相邻组织中和/或周围的感染。组织向内生长还可促进异物(例如,植入式层和钉)被患者身体的接收,并且可降低患者身体拒绝异物的可能性。异物的拒绝可导致外科部位处的感染和/或炎症。
转到附图,其中在所有附图中相似编号指示相似部件,图1示出适于与可植入附属物诸如组织厚度补偿件一起使用的示例性外科缝合和切断器械8010。外科缝合和切断器械8010可包括砧座8014,该砧座可围绕其到细长钉通道8016的枢转附接而被反复打开和闭合。钉施用组件8012可包括砧座8014和通道8016,其中组件8012可朝近侧附接到形成工具部分8022的细长轴8018。当钉施用组件8012闭合时、或至少基本上闭合时,执行部分8022可呈现足够小的横截面,该横截面适于将钉施用组件8012穿过套管针插入。
在各种情况下,钉仓组件8012由连接至细长轴8018的柄部8020操纵。柄部8020可以包括用户控件,诸如:旋钮8030,该旋钮使细长轴8018和钉施用组件8012围绕轴8018的纵向轴线旋转;以及闭合触发器8026,该闭合触发器可以在手枪式握持部8036的前面枢转以闭合钉施用组件8012。例如,当闭合触发器8026被夹紧时,闭合释放按钮8038向外存在于柄部8020上,使得释放按钮8038可被压下以松开闭合触发器8026并打开钉施用组件8012。
可在闭合触发器8026前方枢转的击发触发器8034使钉施用组件8012同时切断和缝合被夹紧在其中的组织。在各种情况下,可使用击发触发器8034来采用多个击发行程以减少每行程需要由外科医生的手施加的力的大小。在某些实施方案中,柄部8020可包括一个或多个可旋转指示器轮,诸如可指示击发进程的可旋转指示器轮8041。如果需要,手动击发释放杠杆8042可允许击发系统在完全击发行进完成之前回缩,并且此外,在击发系统卡住和/或失效的情况下,击发释放杠杆8042可允许外科医生或其他临床医生使击发系统回缩。
关于外科缝合和切断器械8010和适于与本公开一起使用的其他外科缝合和切断器械的附加细节例如在2013年3月27日提交的名称为“FASTENER CARTRIDGE ASSEMBLY”的美国专利申请序列号13/851,693(现为美国专利申请公布2014/0291381)中有所描述,该专利的全部公开内容以引用方式并入本文。此外,通电的外科缝合和切断器械也可与本公开一起使用。参见例如2008年8月12日提交的名称为“POWERED SURGICAL STAPLING DEVICE”的美国专利申请公布2009/0090763,该专利的全部公开内容以引用方式并入本文。
结合图2和图3,击发组件(诸如击发组件9090)可与外科缝合和切断器械8010一起使用以推进包括多个楔形件9204的楔形滑动件9126,所述楔形件被构造成能够将钉从钉施用组件8012部署到捕获在砧座8014和细长钉通道8016之间的组织中。此外,在击发组件9090的远侧部分处的E形梁9102可从钉施用组件8012击发钉,以及在击发期间将砧座8014相对于细长钉通道8016定位。E形梁9102包括一对顶部销9110,可跟随楔形滑动件9126的部分9218的一对中间销9112,和底部销或支脚9114,以及锋利的切割刃9116,该切割刃可被构造成能够在击发组件9090朝远侧推进时切断所捕获的组织。此外,托住切割刃9116的每个垂直端的朝近侧突出的一体成型顶部导向件9118和中间导向件9120可进一步限定组织集结区域9122,从而有助于在切断组织前将组织引导至锋利的切割刃9116。中间导向件9120还可用于通过邻接楔形滑动件9126(图2)的阶梯式中央构件9124来接合并击发钉施用组件8012,所述楔形滑动件通过钉施用组件8012影响钉成形。
在各种情况下,钉仓可包括用于对捕获在从钉仓部署的钉内的组织的厚度进行补偿的装置。参见图4,钉仓(诸如钉仓10000)例如可与外科缝合和切断器械8010一起使用并且可包括刚性的第一部分(诸如支撑部分10010)以及可压缩的第二部分(诸如组织厚度补偿件10020)。支撑部分10010可包括仓体和多个钉腔10012。钉10030例如可以可移除地定位在每个钉腔10012中。主要参见图4和图5,每个钉10030可包括基部10031以及从基部10031延伸的一个或多个腿10032。在钉10030被部署之前,钉10030的基部10031可由定位在支撑部分10010内的钉驱动器支撑,并且同时钉10030的腿10032可至少部分地容纳在钉腔10012内。
在各种情况下,钉10030可被部署在未击发位置与击发位置之间,使得腿10032运动穿过组织厚度补偿件10020、穿透组织厚度补偿件10020的顶部表面、穿透组织T,并且接触与钉仓10000相对定位的砧座。在腿10032抵靠砧座变形时,每个钉10030的腿10032可捕获组织厚度补偿件10020的一部分以及每个钉10030内的组织T的一部分,并且将压缩力施加到组织。对上文进行进一步描述,可使每个钉10030的腿10032向下朝钉的基部10031变形以形成钉截留区域,在该钉截留区域中,组织T和组织厚度补偿件10020可被捕获。在各种情况下,钉截留区域可被限定在已变形的腿10032的内表面与基部10031的内表面之间。钉截留区域的尺寸可取决于若干因素,诸如腿的长度、腿的直径、基部的宽度和/或腿部变形的程度。
在使用中,对上文进行进一步描述并且主要参见图4,外科缝合和切断器械8010的砧座诸如砧座8014可通过按压闭合触发器8026而运动到与钉仓10000相对的闭合位置中以推进E形梁9102。砧座8014可将组织抵靠组织厚度补偿件10020定位,并且在各种情况下,例如将组织厚度补偿件10020抵靠支撑部分10010压缩。一旦砧座8014已适当定位,则可部署钉10030,同样如图4所示。
在各种情况下,如上所述,在许多方面类似于滑动件9126(参见图3)的钉击发滑动件10050可从钉仓10000的近侧端部朝远侧端部10002运动,如图5所示。当击发组件9090被推进时,滑动件10050可接触钉驱动器10040并在钉腔10012内向上提升钉驱动器10040。在至少一个示例中,滑动件10050和钉驱动器10040可各自包括一个或多个斜坡或倾斜表面,所述一个或多个斜坡或倾斜表面可协作以使钉驱动器10040从它们的未击发位置向上运动。钉驱动器10040在它们各自的钉腔10012内被向上提升时,钉驱动器10040可向上提升钉10030,使得钉10030可从其钉腔10012出现。在各种情况下,作为击发序列的一部分,滑动件10050可同时使若干钉向上运动。
参见图5,当钉10030处于它们的未击发位置时,钉10030的钉腿10032可延伸到补偿件10020中超过支撑部分10010。在各种情况下,当钉10030处于它们的未击发位置时,钉腿10032的尖端或钉腿10032的任何其他部分可能不突出穿过组织厚度补偿件10020的顶部组织接触表面10021。在某些情况下,钉腿10032的尖端可包括能够切入和穿透组织厚度补偿件10020的锋利尖端。
参见图6,示出了钉仓组件10。钉仓组件10包括钉仓12。钉仓12在许多方面类似于钉仓10000。与钉仓10000类似,钉仓12包括多个钉,该多个钉容纳在限定于钉仓12中的多个腔或凹坑22中。另外,钉仓12的多个钉可由外科缝合和切断器械8010部署。
钉仓12还包括具有外表面18的仓平台16。钉仓12还包括刀狭槽20,该刀狭槽在切割刃9116推进以切割由外科缝合和切断器械8010所捕获的组织时适应该切割刃。多个凹坑22可以从外表面18延伸到钉仓12中以用于容纳多个钉。滑动件10050穿过钉仓12的推进使得钉仓12的钉从其相应的凹坑22以与钉10030从钉仓10000部署相同或基本上相同的方式部署到组织中,如上所述。
再次参见图6,钉仓组件10还包括组织厚度补偿件或可压缩附属物14。通过将可压缩附属物14部分地熔融到外表面18上以允许可压缩附属物14的熔融部分流到外表面18上来将可压缩附属物14附接到外表面18。可压缩附属物14的熔融部分通过例如冷却而重新固化,这使得可压缩附属物14附接到外表面18。
在某些情况下,钉仓12可以包括被构造成能够加热外表面18的一个或多个加热元件(未示出)。加热的外表面18可以熔融可压缩附属物14的与外表面18接触的部分。在重新固化时,可压缩附属物14的熔融部分可以限定附接区域,该附接区域将可压缩附属物14固定到外表面18。
在至少一种情况下,均匀地加热外表面18。另选地,直接加热外表面18的特定区,而不直接加热其他区。在本文中可以将未直接加热的区称为“未加热”。可压缩附属物14的与直接加热的区接触或紧密接近的部分可以熔融然后重新固化以限定可压缩附属物14与外表面18之间的附接区。可压缩附属物14的与未加热区接触或紧密接近的部分保持不附接到外表面18。
在至少一种情况下,均匀地、或至少基本上均匀地加热外表面18,但外表面18的某些区可以具有比外表面18的其他区更大的热导率。在这类情况下,可压缩附属物14的与较高热导率区接触或紧密接近的部分可以熔融并重新固化以限定可压缩附属物14与外表面18之间的附接区,而可压缩附属物14的与较低热导率区接触或紧密接近的部分保持不附接到外表面18。
如上所述,可以使用外表面18的某些区的选择性或局部加热来限定或产生可压缩附属物14与外表面18之间的独立的附接区域。另选地,可压缩附属物14可以如图6所示专门设计以在存在均匀加热的外表面18时产生选择性附接区域。
在各种情况下,对外表面18的旨在与可压缩附属物14粘合的区进行处理以改善粘合。在至少一种情况下,此类粘合区中的一个或多个可以包括不规则形貌。例如,此类粘合区可以包括比外表面18的其余部分更大的粗糙度。根据一种非限制性理论,更大的粗糙度可以通过增加可用于与可压缩附属物14的熔融部分接触的表面积来改善与可压缩附属物14的熔融部分的粘合。
可以通过任何合适的过程例如机械研磨、化学蚀刻、喷丸法、激光喷丸和/或等离子喷涂来实现粘合区的期望粗糙度。本公开设想到用于产生期望粗糙度的其他过程。
除上述以外,可压缩附属物14还包括主体24。主体24包括面26,该面可贴靠钉仓12的外表面18的至少一部分定位。面26可以包括多个附接区域28和多个非附接区域30,如图6所示。与其中可压缩附属物的整个面附接到表面18相比,可压缩附属物14在附接区域28处到外表面18的选择性附接可以减小从仓平台16释放可压缩附属物14所需的力。
附接区域28由一种或多种生物相容性材料构成。同样,非附接区域30由一种或多种生物相容性材料构成。在各种情况下,从形成非附接区域30的生物相容性材料中排除形成附接区域28的生物相容性材料中的至少一种。在这类情况下,形成非附接区域30的一种或多种生物相容性材料的熔融温度大于附接区域28的已排除生物相容性材料的熔融温度。在某些情况下,附接区域28由生物相容性材料“A”、生物相容性材料“B”和生物相容性材料“C”构成,而非附接区域30由生物相容性材料“A”和生物相容性材料“B”构成,但排除生物相容性材料“C”。在这种情况下,生物相容性材料“C”具有比生物相容性材料“A”和生物相容性材料“B”更低的熔融温度。在将附接区域28和非附接区域30加热到生物相容性材料“C”的熔融温度时,生物相容性材料“C”熔融并从附接区域28流到外表面18上。一旦生物相容性材料“C”重新固化,就在附接区域28与外表面18之间建立了粘合。
在至少一种情况下,非附接区域30可由第一生物相容性材料构成,并且附接区域28可由与第一生物相容性材料不同的第二生物相容性材料构成。第二生物相容性材料可以具有比第一生物相容性材料更低的熔融温度。在这类情况下,使面26暴露于外表面18,该外表面被均匀地加热到大于或等于第二生物相容性材料的熔融温度但低于第一生物相容性材料的熔融温度的温度,使得附接区域28熔融并流到外表面18上。然而,当外表面18的温度低于第一生物相容性材料的熔融温度时,非附接区域30将保持在它们的固相。在重新固化时,附接区域28将可压缩附属物14的主体24可释放地固定到仓平台16的外表面18。
在各种情况下,附接区域28中的一个或多个附接区域和/或非附接区域30中的一个或多个非附接区域可以包含可生物吸收材料,例如,以商品名VICRYL出售的聚乙醇酸(PGA)、聚乳酸(PLA或PLLA)、聚二氧六环酮(PDS)、聚羟基链烷酸酯(PHA)、以商品名Monocryl出售的聚卡普隆25(PGCL)和/或聚己内酯(PCL)。在某些情况下,附接区域28中的一个或多个附接区域和/或非附接区域30中的一个或多个非附接区域可以包含一种或多种复合材料,该一种或多种复合材料包括两种或更多种聚合物,这些聚合物选自包括例如PGA、PLA、PDS、PHA、PGCL和/或PCL的组。在至少一种情况下,第二生物相容性材料由PDS构成。
在至少一种情况下,通过在可压缩附属物14贴靠仓平台16按压或定位时,在附接区域28的第二生物相容性材料中引起暂时相变,将可压缩附属物14固定到仓平台16。在某些情况下,第二生物相容性材料中的暂时相变不会伴有非附接区域30的第一生物相容性材料中的相变。
在某些情况下,通过移除或停用热源来重新固化附接区域28。在至少一种情况下,热源为烘箱,其被构造成能够接纳贴靠仓平台16定位的钉仓12和可压缩附属物14。可以在接纳钉仓12和可压缩附属物14之前和/或之后将烘箱加热到合适的温度。在至少一种情况下,热源可以为热阻电路,其可以被激活以加热外表面18。例如,热阻电路可被布置在仓平台16下方。本公开可设想到其他合适的热源。在某些情况下,除了移除或停用热源之外,还通过主动冷却热源来重新固化附接区域28。例如,可以采用风扇或任何其他冷却系统来将附接区域28冷却到低于第二生物相容性材料的熔融温度的温度。
在至少一种情况下,非附接区域30可由熔融温度大于预先确定的温度的多种生物相容性材料构成。同样,附接区域28可由多种生物相容性材料构成;然而,附接区域28的生物相容性材料包括熔融温度等于或小于预先确定的熔融温度的至少一种生物相容性材料。换句话讲,附接区域28的生物相容性材料包括熔融温度小于非附接区域30的生物相容性材料的熔融温度的至少一种生物相容性材料。在可压缩附属物14的面26加热到预先确定的温度时,附接区域28熔融,或至少部分地熔融,用于与外表面18粘合,而非附接区域30保持在它们的固相并且不粘合到外表面18。
在各种情况下,除上述以外,非附接区域30仅需排除熔融温度等于或小于在附接区域28中具有最低熔融温度的生物相容性材料的熔融温度的生物相容性材料。这就是说,附接区域28的组合物不需限制为一种生物相容性材料。相反,附接区域28可由多种生物相容性材料构成,只要附接区域28的多种生物相容性材料包括熔融温度小于非附接区域30的生物相容性材料的熔融温度的至少一种生物相容性材料。
再次参见图6,可压缩附属物14的主体24可以包括纤维构造物,该纤维构造物包括多个纤维。例如,合适的可压缩附属物可以包括网状物、其他丝状结构、非编织结构、海绵、编织或非编织材料、针织或非针织材料、毡、盐洗脱多孔材料、模制多孔材料和/或3D印刷生成的附属物。本公开可设想到用于制备可压缩附属物14的其他技术。
在至少一种情况下,非附接区域30可以包括多个第一纤维,并且附接区域28可以包括与多个第一纤维不同的多个第二纤维。例如,多个第二纤维可以具有比多个第一纤维更低的熔融温度。在这类情况下,使可压缩附属物14的面26暴露于外表面18,该外表面被均匀地加热到大于或等于多个第二纤维的熔融温度但低于多个第一纤维的熔融温度的温度,使得附接区域28的多个第二纤维熔融并流到外表面18上。然而,当外表面18的温度低于多个第一纤维的熔融温度时,非附接区域30的多个第一纤维将保持在它们的固相。
可压缩附属物14的主体24的纤维构造物可以被按压到外表面18上或贴靠外表面18定位,该外表面被均匀地加热到足以熔融附接区域28的纤维而不会熔融非附接区域30的纤维的温度。在重新固化时,附接区域28的熔融纤维将可压缩附属物14的主体24固定到仓平台16的外表面18。
在各种情况下,外表面18可以包括用于与附接区域28粘合的粘合区。在某些情况下,对粘合区进行处理以改善附接区域28与外表面18之间的粘合。在至少一种情况下,粘合区中的一个或多个粘合区可以包括不规则形貌,与外表面18的其余部分相比,这增大了粘合区的粗糙度。如上所述,增大的粗糙度可以对应于可用于与附接区域28粘合的粘合区的表面积的增大。
参见图7,钉仓组件40包括钉仓42,该钉仓在许多方面类似于钉仓12和10000。与钉仓10000类似,钉仓42包括多个钉,例如容纳在多个腔或凹坑52中的钉仓42中的多个钉43。此外,与钉仓10000的钉类似,钉43可以由外科缝合和切断器械8010从钉仓42部署到所捕获的组织中。
钉仓42包括仓平台46。与仓平台16类似,仓平台46包括外表面例如外表面48。多个凹坑52从仓平台46延伸到钉仓42中并且被构造成能够容纳多个钉43,如图7所示。当钉仓42与外科缝合和切断器械8010一起使用时,滑动件10050穿过钉仓42的推进使得钉43从其相应的凹坑52以与钉10030从钉仓10000部署相同或基本上相同的方式部署到组织中。
钉仓组件40包括层例如组织厚度补偿件或可压缩附属物。在示出的实施方案中,钉仓组件40包括可压缩附属物14。可压缩附属物14与钉仓42的仓平台46组装在一起,或贴靠该仓平台定位。可压缩附属物14固定到仓平台46上的多个粘合区56,如下文更详细地描述。
在某些情况下,粘合区56可被布置成排。每排都可以包括多个粘合区56。在图7所示的实施方案中,粘合区56被布置成在刀狭槽20的每一侧上沿仓平台46的长度延伸的三个平行排56a至56c。另选地,粘合区56可被布置成在刀狭槽20的每一侧上沿仓平台46的长度延伸的两个平行排。另选地,粘合区56可被布置成在刀狭槽20的每一侧上沿仓平台46的长度延伸的单个排。另选地,粘合区56可被布置成非平行排。在某些情况下,粘合区56可以沿仓平台46的周长或周边布置。
中间排56b相对于外部排56a、56c偏移。换句话讲,外部排56a、56c的一对粘合区与中间排56b的两个连续粘合区之间的间隙侧向地对准。间隙可以包括凹坑52。在某些情况下,多个粘合区56和多个凹坑52可被布置成排,使得每个粘合区56都设置在两个连续凹坑52之间,如图7所示。本公开可设想到粘合区56相对于仓平台46的其他布置。
如图7所示,仓平台42可以包括从外表面48延伸出的多个凹坑扩展部54。凹坑扩展部54可以提供多种功能。例如,凹坑扩展部54可以保护延伸到凹坑52外部的处于其未击发位置的钉43的腿。另外,凹坑扩展部54可以在钉43正被击发时,引导这些钉。粘合区56可以在两个不同凹坑52的两个相邻凹坑扩展部54之间延伸。换句话讲,粘合区56可以在两个相邻的无创伤凹坑扩展部54之间延伸,这两个凹坑扩展部各自保护不同钉的钉腿。
在某些情况下,多个凹坑扩展部54可以与多个粘合区56布置成排,例如排56a至56c。在至少一种情况下,这个排中的多个粘合区56中的每一个粘合区都可以定位在两个连续的无创伤凹坑扩展部54之间。例如,如图7所示,粘合区56’定位在远侧钉43a与近侧钉43b之间,使得粘合区56’在保护远侧钉43a的近侧腿45的第一凹坑扩展部54a与保护近侧钉43b的远侧腿(未示出)的第二凹坑扩展部54b之间延伸。
如上面所指出的那样,仓平台46的粘合区56可以从外表面48延伸出。换句话讲,粘合区56可以相对于外表面48升高或逐渐提升,如图7所示。在各种情况下,附接区域28可以定位在粘合区56上。粘合区56相对于外表面48的升高可以防止或至少限制附接区域28的熔融材料溢流到粘合区56外部,这可以帮助维持可压缩附属物14与仓平台46之间到由粘合区56限定的独立区域的附接。
在各种情况下,对仓平台46的粘合区56进行处理以改善它们到可压缩附属物14的对应的附接区域28的附接。在至少一种情况下,粘合区56中的一个或多个粘合区可以包括不规则形貌,如图7所示。换句话讲,粘合区56可以包括比外表面48的其余部分更大的粗糙度。更大的粗糙度改善了与熔融附接区域28的粘合。可以通过任何合适的过程例如机械研磨、化学蚀刻、喷丸法、激光喷丸和/或等离子喷涂来实现粘合区的期望粗糙度。本公开设想到用于产生期望粗糙度的其他过程。
在各种情况下,仓平台46还可以包括一个或多个附接构件58。附接构件58有助于将可压缩附属物14固定到仓平台46。在某些情况下,附接构件58包括倒钩,这些倒钩可以帮助维持在用于将可压缩附属物14粘合到仓平台46的熔融和/或重新固化期间,在粘合区56与可压缩附属物14的对应的附接区域48之间的初始对准。可压缩附属物14可以贴靠仓平台46按压,使得附接构件58接合可压缩附属物14的面26,和/或建立粘合区56与附接区域28之间的初始对准。附接区域28然后熔融到粘合区56上。在重新固化时,附接区域58将可压缩附属物14固定到粘合区56。
现在参见图8,钉仓组件60与外科缝合和切断器械例如外科缝合和切断器械8010组装在一起。钉仓组件60包括钉仓62。钉仓62在许多方面类似于钉仓12、42和10000。钉仓62包括仓平台66,该仓平台包括外表面例如外表面68。钉仓组件60还包括可压缩层64和粘合层65。粘合层65可由多种粘合岛状物67构成,如图8所示。粘合岛状物67可以彼此间隔开并以预先确定的布置设置在仓平台66的外表面68上。粘合岛状物67被布置成围绕、或至少部分地围绕刀狭槽20的图案。换句话讲,粘合岛状物67被布置成沿刀狭槽20的周边或周长的图案。本公开可设想到粘合岛状物67到外表面68上的其他布置。
在某些情况下,粘合岛状物67中的一个或多个包括圆柱形状,如图8所示。本公开还可设想到其他形状。例如,一个或多个粘合岛状物67可以包括穹顶形状。在图8所示的实施方案中,粘合岛状物67’设置在外表面68中在该外表面的远侧部分处,该远侧部分在刀狭槽20远侧。
在各种情况下,粘合层65的粘合岛状物67可以在制造期间形成在仓平台66上。另选地,例如,粘合层65可以由外科医生附接到仓平台66。可以采用任何合适的附接技术来将粘合层65固定到仓平台66。在至少一种情况下,粘合层65可以包括例如一个或多个连接带69。例如,连接带69还将粘合岛状物67互连,并且可以用于将粘合层65固定到仓平台66。
在任何情况下,可以通过将可压缩层64贴靠熔融的、或至少部分熔融的粘合岛状物67按压或定位,然而允许或引起粘合岛状物67重新固化来将可压缩层64固定到仓平台66。换句话讲,可以通过在可压缩层64贴靠粘合岛状物67按压或定位时,在粘合岛状物67中引起暂时相变来将可压缩层64固定到仓平台66。
在一个实施方案中,可压缩层64贴靠粘合岛状物67按压或定位。然后,将粘合岛状物67加热到预先确定的温度,这使得粘合岛状物67熔融、或至少部分地熔融。最终,粘合岛状物67冷却,或被允许冷却到低于预先确定的温度,从而引起粘合岛状物67重新固化,并将可压缩层64固定到仓平台66。另选地,可以在将可压缩层64贴靠粘合岛状物67按压或定位之前,将粘合岛状物67加热到预先确定的温度。
在某些情况下,通过移除或停用热源来重新固化粘合岛状物67。在其他情况下,除了移除或停用热源之外,还通过主动冷却热源来重新固化粘合岛状物67。例如,可以采用风扇或任何其他冷却系统来将粘合岛状物67冷却到低于预先确定的温度的温度。
在至少一种情况下,可压缩层64可由第一生物相容性材料构成,并且粘合岛状物67可由与与第一生物相容性材料不同的第二生物相容性材料构成。第二生物相容性材料可以具有比第一生物相容性材料更低的熔融温度。在这类情况下,将粘合岛状物67加热到第二生物相容性材料的熔融温度,但低于第一生物相容性材料的熔融温度,引起粘合岛状物67熔融并流入可压缩层64中和外表面68上。然而,可压缩层64将保持在固相。在重新固化时,粘合岛状物67将可压缩层64固定到仓平台66的外表面68。
在至少一种情况下,通过以下方式来将可压缩层64固定到仓平台66:在可压缩层64贴靠仓平台66按压或定位时,在粘合岛状物67的第二生物相容性材料中引起暂时相变或转变。在某些情况下,第二生物相容性材料中的暂时相变不会伴有可压缩层64的第一生物相容性材料中的相变。
在各种情况下,压缩层64和/或粘合层67可以包括可生物吸收材料,例如,以商品名Vicryl出售的聚乙醇酸(PGA)、聚乳酸(PLA或PLLA)、聚二氧六环酮(PDS)、聚羟基链烷酸酯(PHA)、以商品名Monocryl出售的聚卡普隆25(PGCL)和/或聚己内酯(PCL)。在某些情况下,可压缩层64和/或粘合层67可以包含复合材料,这些复合材料包括两种或更多种聚合物,这些聚合物选自包括例如PGA、PLA、PDS、PHA、PGCL和/或PCL的组。在至少一种情况下,第二生物相容性材料由例如PDS构成。
读者将会知道,本公开的可压缩附属物和/或层能够以与可压缩附属物和/或层附接到本公开的钉仓相同的方式附接到砧座,例如,外科缝合和切断器械8010的砧座8014,反之亦然。例如,可以通过将砧座8014均匀地加热到足以熔融附接区域28的纤维但不熔融非附接区域30的纤维的温度来将可压缩附属物14附接到砧座8014。在重新固化时,附接区域28的熔融纤维将可压缩附属物14的主体24固定到砧座8014。同样,可以采用粘合层65来将可压缩层64以与粘合层65将可压缩层64固定到钉仓62相同的方式固定到砧座8014。
主要参见图1和图9,外科缝合和切断器械,例如,外科缝合和切断器械8010可包括可压缩附属物组件104。可压缩附属物组件80可以附接到外科缝合和切断器械8010的钳口构件。在至少一种情况下,可压缩附属物组件104附接到砧座例如砧座84(图9),该砧座在许多方面类似于砧座8014(图1)。
另选地,可压缩附属物组件104可以附接到钉仓,例如,钉仓10000。在某些情况下,第一可压缩附属物组件104附接到砧座,并且第二可压缩附属物组件104附接到相同外科缝合和切断器械的钉仓。在这类情况下,在外科缝合和切断器械转变到闭合构型时,组织被捕获在第一和第二可压缩附属物组件104之间。
与砧座8014类似,砧座84包括延伸穿过砧座84的长度的细长狭槽86,该细长狭槽限定在细长狭槽86的第一侧90上延伸的第一外表面88,和在细长狭槽86的第二侧94上延伸的第二外表面92,如图9所示。在某些情况下,砧座84可相对于钉仓例如钉仓10000移动以将组织捕获在该砧座和钉仓之间。另选地,钉仓10000可以相对于砧座84移动以将组织捕获在该钉仓和砧座之间。另选地,砧座84和钉仓10000可以朝向彼此移动以将组织捕获在该砧座和钉仓之间。击发组件,例如,击发组件9090(图3)可以与外科缝合和切断器械8010一起用于将钉从钉施用组件8012(图1)部署到被捕获在砧座84与钉仓10000之间的组织中,如上文更详细地描述。
参见图9,第一外表面88包括多个凹坑96。同样,第二外表面92包括多个凹坑98。例如,凹坑96和98可以被构造成能够在钉从钉仓10000部署时,接纳钉并使钉变形。此外,细长狭槽86可以被构造成能够在切割刃9116(图3)推进以切割由外科缝合和切断器械8010所捕获的组织时,适应该切割刃。
参见图3和图9,砧座84的内表面100可以限定砧座84内的内部空间102。击发组件9090的销9110(图3)可以骑靠在内表面102上,并且可以在击发组件9090推进以将钉部署到由钉施用组件8012捕获的组织中时,被促动穿过内部空间102。
再次参见图9,可压缩附属物组件104包括附接层106、第一可压缩附属物108和第二可压缩附属物110。附接层106可以被构造成能够将第一可压缩附属物108和第二可压缩附属物110联接到砧座84,如下文更详细地描述。附接层106的第一节段106a可定位在细长狭槽86的第一侧90上,并且第二节段106b可定位在细长狭槽86的第二侧94上。细长狭槽86将第一节段106a与第二节段106b分开。附接层106的中间节段106c在第一节段106a与第二节段106b之间延伸。中间节段106c跨接细长狭槽86。在某些情况下,中间节段106c仅部分地跨接细长狭槽86。
在某些情况下,中间节段106c完全跨接细长狭槽86。在至少一种情况下,中间节段106c可由多个跨接部分107构成,如图9所示。每个跨接部分107都在第一节段106a和第二节段106b之间延伸。跨接部分107彼此间隔开。中间节段106b中的间隙109将跨接部分107分离。间隙109使细长狭槽86暴露。
如图9所示,跨接部分107可以沿细长狭槽86巧妙地布置,以维持附接层106的完整性,同时使得在切割刃9116(图3)推进以切割中间层106c和被捕获在钉仓与砧座84之间的组织时,驱动该切割刃所需的击发力最小化。间隙109和跨接部分107沿细长狭槽86的至少一部分交替位置。
用于制造可压缩附属物组件(例如,可压缩附属物组件104)的各种技术在名称为“IMPLANTABLE LAYERS AND METHODS FOR ALTERING IMPLANTABLE LAYERS FOR USE WITHSURGICAL FASTENING INSTRUMENTS”并且于2014年2月24日提交的美国专利申请序列号14/187,383(现为美国专利申请公布2015/0238185)中有所描述,该专利的全部公开内容以引用方式并入本文。在至少一种情况下,可以在第一可压缩附属物108和第二可压缩附属物110的制造期间,使用例如冻干工艺,将附接层106附接到第一可压缩附属物108和第二可压缩附属物110。
另选地,可以在第一可压缩附属物108和第二可压缩附属物110制成后,将附接层106附接到第一可压缩附属物108和第二可压缩附属物110。例如,如本文其他地方更详细地描述,第一可压缩附属物108可以贴靠附接层106的部分熔融的第一节段106a定位或按压。在重新固化时,第一节段106a附接到第一可压缩附属物108。例如,以类似方式,第一节段106a可以附接到第一外表面88,第二节段106b可以附接到外表面92,并且第二节段106b可以附接到第二可压缩附属物110。
如图9所示,附接层106的第一节段106a在第一可压缩附属物108和第一外表面88之间延伸。同样,附接层106的第二节段106b可以在第二可压缩附属物110和外表面92之间延伸。第一节段106a将第一可压缩附属物108与第一外表面88完全分开。此外,第二节段106b将第二可压缩附属物110与外表面92完全分开。另选地,可压缩附属物组件可以包括附接层206,该附接层将一个或多个可压缩附属物与砧座仅部分地分开。换句话讲,第一节段106a可以包括被构造成能够将第一可压缩附属物108暴露于第一外表面88的一个或多个间隙。同样,第二节段106b可以包括被构造成能够将第二可压缩附属物110暴露于外表面92的一个或多个间隙。
附接层106的高度小于第一可压缩附属物108的高度和/或第二可压缩附属物110的高度。另选地,附接层106的高度可以大于或等于第一可压缩附属物108的高度和/或第二可压缩附属物110的高度。在至少一种情况下,附接层106由膜构成,该膜可以附接到第一可压缩附属物108和/或第二可压缩附属物108。
参见图10,可压缩附属物组件204可以包括附接层206,该附接层将第一可压缩附属物208与第一外表面88部分地分离和/或将第二可压缩附属物210与外表面92部分地分离。可压缩附属物组件204在许多方面类似于可压缩附属物组件104。可压缩附属物组件204可以与砧座84组装在一起。
可压缩附属物组件204的附接层206包括可定位在细长狭槽86的第一侧90上的第一节段206a,和可定位在细长狭槽86的第二侧94上的第二节段206b。另外,附接层206的中间节段206c在第一节段206a和第二节段206b之间延伸。中间节段跨接细长狭槽86,如图10所示。在某些情况下,中间节段206c仅部分地跨接细长狭槽86。
可压缩附属物组件204的第一可压缩附属物208附接到第一节段206a,并且可压缩附属物组件204的第二可压缩附属物210附接到第二节段206b。当可压缩附属物组件204与砧座84组装在一起时,如图10所示,第一可压缩附属物208沿远离细长狭槽86的第一方向侧向地延伸超过第一节段206a。此外,第一外表面88还沿第一方向侧向地延伸超过第一节段206a。同样,第二可压缩附属物210沿远离细长狭槽86且与第一方向相反的第二方向侧向地延伸超过第二节段206b。此外,外表面92还沿第二方向侧向地延伸超过第二节段206b。因此,如图10所示,第一可压缩附属物208的外部部分208a与外表面88直接接触,而阶梯式内部部分208b通过附接层206的第一节段206a与外表面88分开。同样,第二可压缩附属物210的外部部分210a与外表面92直接接触,而阶梯式内部部分210b通过附接层206的第二节段206b与外表面92分开。
阶梯式内部部分208b和210b分别限定第一边界208c和第二边界210c。附接层206在第一边界208c与第二边界210c之间横向延伸,横跨细长狭槽86,以将第一可压缩附属物208和第二可压缩附属物210互连。当可压缩附属物组件204与砧座84组装在一起时,如图10所示,附接层206贴靠砧座84的中心区域定位,从而在内排凹坑96的与内排凹坑98之间延伸。此外,内部阶梯式部分208b和210b通过附接层206与砧座84分开。
除上述以外,第一边界208c在内排凹坑96的内部,并且第二边界210c在内排凹坑98的内部。附接层206的第一节段206a贴靠外表面88的一部分定位,从而在细长狭槽86与内排凹坑96之间延伸。此外,外部部分208a直接贴靠外表面88的凹坑96定位。同样,附接层206的第二节段206b贴靠外表面92的一部分定位,从而在细长狭槽86与内排凹坑98之间延伸。此外,外部部分210a直接贴靠外表面92的凹坑98定位。在某些情况下,边界208c和210c可以侧向地间隔开更远,以允许附接层206进一步包含一排或多排凹坑96和/或一排或多排凹坑98。
附接层206的高度小于第一可压缩附属物208的高度和/或第二可压缩附属物210的高度。另选地,附接层206的高度可以大于或等于第一可压缩附属物208的高度和/或第二可压缩附属物210的高度。在至少一种情况下,附接层206由膜构成,该膜可以附接到第一可压缩附属物208的内部阶梯式部分208b和/或第二可压缩附属物108的内部阶梯式部分210b。
参见图11至图15,可压缩附属物组件304包括附接层306,该附接层包括凸起的、升高的或逐渐提升的中间节段306c。可压缩附属物组件304在许多方面类似于可压缩附属物组件104。例如,可压缩附属物组件304可以与砧座84组装在一起,如图11所示。另外,例如,可压缩附属物组件304的第一可压缩附属物108可以附接到附接层306的第一节段306a,并且可压缩附属物组件304的第二可压缩附属物110可以附接到附接层306的第二节段306b。
中间节段306c被构造成能够突出到限定于第一可压缩附属物108与第二可压缩附属物110之间的间隙中。另选地,中间节段306c可以被构造成能够在可压缩附属物组件304与砧座84组装在一起时,突出到细长狭槽86中,如图12所示。在某些情况下,中间节段306c可以包括被构造成能够突出到细长狭槽86中的第一部分和被构造成能够突出到限定于第一可压缩附属物108与第二可压缩附属物110之间的间隙中的第二部分。
在某些情况下,中间节段306c用作用于将第一可压缩附属物108贴靠附接层306的第一节段306a对准和/或将第二可压缩附属物110贴靠附接层306的第二节段306b对准的对准特征结构。如图11所示,中间节段306c包括侧壁320和322。第一可压缩附属物108被构造成能够抵靠侧壁320,并且第二可压缩附属物108被构造成能够抵靠侧壁322。
在某些情况下,中间节段306c用作用于将附接层306贴靠砧座84在适当位置对准的对准特征结构。如图12和图13所示,中间节段306c包括能够插入细长狭槽86中的多个突出部307。突出部307彼此间隔开并且沿中间节段306c的长度纵向地布置成一排。在至少一种情况下,突出部307可以彼此等距。另选地,突出部307可以在中间节段306c的第一部分比在中间节段306c的第二部分更靠近彼此布置。在至少一种情况下,突出部307中的一个或多个突出部包括具有矩形形状、或至少基本上矩形形状的顶表面。本公开可设想到其他形状,例如,圆形形状或穹顶形状。
除上述以外,突出部307沿细长狭槽86的长度纵向地布置成一排,并且尺寸被设计为配合到细长狭槽86中。突出部307用作用于将附接层306贴靠砧座84在适当位置对准的对准特征结构。在某些情况下,突出部307的尺寸能够被设计为配合到限定于第一可压缩附属物108与第二可压缩附属物110之间的间隙中。突出部307可以用作对准特征结构,其用于将第一可压缩附属物108贴靠附接层306的第一节段306a对准和/或将第二可压缩附属物110贴靠附接层306的第二节段306b对准。
在至少一种情况下,细长狭槽86的开口略微大于突出部307的宽度。另选地,细长狭槽86的开口可以略微小于突出部307的宽度,这可能会引起突出部307在被压到细长狭槽86中时略微变形。变形的突出部307可以用作用于将可压缩附属物组件304固定到砧座84的锚定特征结构。
参见图14和图15,组织夹在可压缩附属物组件304和可压缩附属物组件311之间。使用外科缝合和切断器械例如外科缝合和切断器械8010来缝合和切割组织。将多个钉305从钉仓例如钉仓1000(图17)部署,以将组织捕获在可压缩附属物组件304与可压缩附属物组件311之间。当切割刃9116(图3)推进穿过纵向狭槽86时,将所捕获的组织与附接层306的突出部307一起切断。可压缩附属物组件304,其最初附接到砧座84,现在从砧座84释放,并与钉组织一起保留在患者体内。同样,可压缩附属物组件311,其最初附接到钉仓10000,现在从钉仓10000释放,并与钉组织一起保留在患者体内。
在图16所示的实施方案中,中间节段306c包括沿中间节段306c的长度纵向地延伸的杆309。杆309包括具有矩形形状、或至少基本上矩形形状的顶表面。本公开可设想到其他形状,例如,穹顶形状或弯曲形状。杆309沿细长狭槽86的长度纵向地延伸,并且尺寸被设计为配合到细长狭槽86中。在至少一种情况下,杆309尺寸被设计为紧密地或紧紧地配合到细长狭槽86中。在至少一种情况下,细长狭槽86的开口略微大于杆309的宽度。另选地,细长狭槽86的开口可以略微小于杆309的宽度,这可能会引起杆309在被压到细长狭槽86中时略微变形。变形的杆309可以用作用于将可压缩附属物组件304固定到砧座84的锚定特征结构。此外,杆309可以用作对准特征结构,其用于将附接层306贴靠砧座84在适当位置对准。
与突出部307类似,杆309的尺寸可以被设计为配合到限定于第一可压缩附属物108和第二可压缩附属物110之间的间隙中。杆309可以用作对准特征结构,其用于将第一可压缩附属物108贴靠附接层306的第一节段306a对准和/或将第二可压缩附属物110贴靠附接层306的第二节段306b对准。
参见图17,可压缩附属物组件404与砧座84组装在一起。可压缩附属物组件404在许多方面类似于可压缩附属物组件104。例如,可压缩附属物组件404包括附接层106。如以上更详细描述,附接层106包括在第一节段106a与第二节段106b之间延伸的跨接部分107。
如图17所示,可压缩附属物组件404还包括可压缩层或附属物408,该可压缩层或附属物408在许多方面类似于可压缩附属物108和110。此外,可压缩附属物408包括可定位在细长狭槽86的第一侧90上的第一可压缩部分408a和可定位在细长狭槽86的第二侧94上的第二可压缩部分408b。换句话讲,当可压缩附属物组件404与砧座84组装在一起时,细长狭槽86将第一可压缩部分408a与第二可压缩部分408b分离。可压缩附属物408的中间可压缩部分408c在第一可压缩部分408a和第二可压缩部分408b之间延伸。中间可压缩部分408c跨接细长狭槽86,如图17所示。在某些情况下,中间可压缩部分408c仅部分地跨接细长狭槽86。在某些情况下,中间可压缩部分408c完全覆盖细长狭槽86。
参见图17,中间可压缩部分408c包括在第一可压缩部分408a和第二可压缩部分408b之间延伸的多个跨接部分407。跨接部分407以与附接层106的跨接部分107彼此隔开相同或至少基本上相同的方式彼此间隔开。限定于跨接部分107之间的间隙109也在与跨接部分107对准的对应的跨接部分407之间延伸,使得细长狭槽86通过间隙109暴露出来。然而,在某些情况下,跨接部分107和跨接部分407可以不对准,以防止或减少完全的间隙。
附接层106的高度小于可压缩附属物408的高度。换句话讲,附接层106可能比可压缩附属物408更薄。另选地,在某些情况下,附接层106的高度可以大于或等于可压缩附属物408的高度。在至少一种情况下,附接层106由膜构成,该膜可以附接到可压缩附属物408,使得桥接部分407与桥接部分107对准,如图17所示。
参见图18和图16,可压缩附属物组件504包括可压缩层506、第一附接构件508和第二附接构件510。据设想,可压缩附属物组件504仅包括一个附接构件。另选地,可压缩附属物组件504可以包括三个或更多个附接构件。如图19所示,可压缩附属物组件504可以与外科缝合和切断器械的钳口构件例如外科缝合和切断器械8010的砧座84组装在一起。附接构件508和510被构造成能够将可压缩层506可释放地附接到砧座84。
再次参见图19,切割刃9116已将可压缩附属物组件504的可压缩层506切断成在砧座84的第一侧90上的第一可压缩部分506a和在砧座84的第二侧92上的第二可压缩部分506b。当切割刃9116推进穿过细长狭槽86时,还可以由切割刃9116切断外科缝合和切断器械8010所捕获的组织以及可压缩层506。可以将已切断组织的第一部分与第一可压缩部分506a缝合在一起,并且可以将已切断组织的第二部分与第二可压缩部分506b缝合在一起。
在某些情况下,第一可压缩部分506a和第二可压缩部分506b可以是单独地附接到砧座84的独立的构件。在此类情况下,切割刃9116可以在切断所捕获组织时,不切断可压缩层506,如上所述。相反,切割刃9116可以在第一可压缩部分506a和第二可压缩部分506b之间通过。
再次参见图18和图16,附接构件508和510彼此间隔开。通道512在附接构件508和510之间延伸,用于在切割刃9116推进穿过细长狭槽86时,适应切割刃9116。当可压缩附属物组件504与砧座84组装在一起时,第一附接构件508与砧座84的第一侧90的第一凸缘91配合地接合,并且第二附接构件510与砧座84的第二侧92的第二凸缘93配合地接合。附接构件508和510包括“C”形外形,这些外形的尺寸被设定成和/或具有足够的弹性以分别围绕凸缘93和95扣合接合,从而将可压缩附属物组件固定到砧座84。附接构件508和510的配合凹陷部514和516分别被构造成能够分别接纳凸缘91和93。
除上述以外,第一附接构件508包括第一附接部分508a,该第一附接部分可贴靠内表面100的内部部分100’定位。内部部分100’可以形成第一凸缘91的顶表面。附接构件508的第二附接部分508b附接到可压缩层506的中间可压缩部分506c。联接部分508c将第一附接部分508a和第二附接部分508b互连。联接部分508c延伸到细长狭槽86中,并贴靠凸缘91的侧壁95定位。
与第一附接构件508类似,第二附接构件510包括第一附接部分510a,该第一附接部分可贴靠内表面100的内部部分100”定位。内部部分100”可以形成第二凸缘93的顶表面。附接构件510的第二附接部分510b附接到可压缩层506的中间可压缩部分506c。与联接部分508c类似,联接部分510c将第一附接部分510a和第二附接部分510b互连。联接部分510c延伸到细长狭槽86中,并贴靠凸缘97的侧壁97定位。
如图18所示,附接构件508和510,当与可压缩层506组装在一起时,取向成使得第二附接构件510是第一附接构件508的镜像。附接构件508和510沿可压缩层506彼此并行地,或至少基本上并行地延伸。联接部分508c与联接部分510c之间的空间限定通道512,该通道被构造成能够适应切割刃9116的推进,如上所述。此外,当击发组件9090推进以将钉部署到由外科缝合和切断器械8010捕获的组织中时,击发组件9090的销9110(图3)骑靠在第一附接部分508a和510a上。
再次参见图18,附接构件508和510沿可压缩层506的整个长度延伸。另选地,附接构件508和510可以沿可压缩层506的长度的一部分延伸。在至少一种情况下,附接构件508和510可以沿可压缩层506的长度的中间部分延伸。在至少一种情况下,第一附接构件508沿可压缩层506的长度的第一部分延伸,而第二附接构件510沿可压缩层506的长度的与第一部分不同的第二部分延伸。
在某些情况下,第二附接部分508b和510b中的一者或两者可以嵌入在中间可压缩部分506c中。在至少一种情况下,第二附接部分508b和510b中的一者或两者可以插入,或部分地插入冻干以产生可压缩层506的溶液中。另选地,第二附接部分508b和510b中的一者或两者可以在可压缩层506制成后附接到可压缩层506。在将第二附接部分508b和510b附接到可压缩层506例如生物相容性粘合剂的过程中,可以采用任何附接技术。
参见图20,示出了可压缩附属物组件604。可压缩附属物组件604在许多方面类似于可压缩附属物组件504。例如,可压缩附属物组件604可以与外科缝合和切断器械的钳口构件例如外科缝合和切断器械8010的砧座84组装在一起。然而,可压缩附属物组件604不包括间隔开的附接构件。相反,附接构件以单个附接层607的形式联合在一起,该单个附接层607成形为形成附接部分508a和510a。附接层607被构造成能够将可压缩附属物组件604可释放地附接到砧座84。
在至少一种情况下,附接层607形成为平坦的,或至少基本上平坦的层或膜,其改良成包括附接部分508a和510a的期望形状。另选地,附接层607可以在形成期间采取其期望形状。例如,模具,其包括期望形状,可以接纳熔融的生物相容性材料,该熔融的生物相容性材料在模具内部固化,形成附接层607的期望形状。本公开设想到用于制造附接层607的其他技术。
再次参见图20,附接层607包括第二中间附接部分609,该第二中间附接部分替代附接部分508b和510b。中间附接部分609附接到中间可压缩部分506c。在至少一种情况下,中间附接部分609嵌入、或至少部分地嵌入中间可压缩部分506c中。此外,联接部分508c和510c沿远离可压缩层506的中间可压缩部分506c的方向从中间附接部分609的相对的两端部突出以限定通道512。切割刃9116在其切穿中间附接部分609、中间可压缩部分506c和击发序列期间捕获的组织时,在联接部分508c与510c之间穿过通道512推进。
配合凹陷部614和616在与通道512相反的侧上限定于附接层607与可压缩层506之间,如图20所示。配合凹陷部614和616被构造成能够分别接纳凸缘91和93。当可压缩附属物组件604与砧座84组装在一起时,凸缘91定位在第一附接部分508a与可压缩层506的第一可压缩部分506a之间,并且凸缘93定位在第一附接部分510a与可压缩层506的第二可压缩部分506b之间。
在某些情况下,附接层607和/或可压缩层506可以包括厚度和边缘条件的变化,以减少周围组织中组织创伤的可能性和/或帮助在附接、操纵和/或从砧座84的释放期间维持可压缩附属物组件604的完整性。在至少一种情况下,附接层607和/或可压缩层506用无创伤边缘和/或较厚边缘增强。
参见图21,附接层607’包括滚边620和622,这减少了周围组织中组织创伤的可能性。此外,附接层607’在中间附接部分609用相对较厚区域624和626增强,以改善在附接、操纵和/或从砧座84的释放期间可压缩附属物组件604的稳健性。可压缩附属物组件604的其他高应力区域也可以相同或类似的方式增强。
现在参见图22至图24,可压缩附属物组件704包括可压缩层506和多个附接构件708,该多个附接构件彼此间隔开并且沿可压缩层506的长度纵向地布置成一排。在某些情况下,附接构件708沿可压缩层506的中心部分布置。在某些情况下,附接构件708沿可压缩层506的远侧部分和/或近侧部分布置。与附接构件508和510类似,附接构件708被构造成能够将可压缩层506可释放地附接到砧座84。然而,与附接构件508和510不同,每个附接构件708都能够同时贴靠凸缘95和97定位。当切割刃9116穿过细长狭槽86推进以切割可压缩层506和所捕获的组织时,附接构件708被切割刃9116切断。
附接构件708各自包括基部710、从基部延伸出的杆状物712和从杆状物712延伸出的头部或冠部714。当可压缩附属物组件704与砧座84组装在一起时,杆状物712定位在细长狭槽86中,如图23所示,并且头部714存在于砧座84内的内部空间102中。头部714包括与穹顶形状类似的横截面积,其横向延伸越过杆状物712,以同时接合砧座84的内表面100’和100”,如图23所示。本公开可设想到头部714的其他形状。
头部714的侧向伸出部716和718分别包括平坦表面720和722,这些平坦表面分别抵靠内表面100’和100”。表面720和722不需要完全平坦。在某些情况下,表面720和722可以粗糙化以改善贴靠内表面100’和100”的牵引。抓持特征结构可以结合到表面720和722中。在某些情况下,例如,可以采用生物相容性粘合剂来将表面720和722粘合到内表面100’和100”。
再次参见图22,头部714和/或杆状物712被构造成能够在击发序列期间,在E形梁9102抵靠头部714朝远侧推进时,沿远侧方向弯曲。朝近侧突出的顶部导向件9118可以推压头部714,使头部714向前和向下弯曲,以允许为E形梁9102的通过留出空间。销9110可以穿过侧向伸出部716和718的顶部。当侧向伸出部716和718贴靠内表面100’和100”变平时,头部714可有助于阻止在E形梁9102前面的组织进入内部空间102并扰乱销9110的推进。这一附加功能可以改善击发组件9090的性能,并通过防止被处理组织被截留在砧座84内来减少对被处理组织的潜在创伤。如图22所示,头部714和杆状物712包括减小的横截面积。换句话讲,头部714和杆状物712基本上平坦化以改善弯曲和/或促进头部714到内部空间102的插入。另外,在各种情况下,头部714和/或杆状物712由、或至少部分地由弹性生物相容性材料构成,以改善弯曲和/或促进头部714到内部空间102的插入。
参见图24,基部710嵌入在可压缩层506中。在某些情况下,基部710仅部分地嵌入在可压缩层506中。在某些情况下,基部710并不嵌入在可压缩层506中,而是相反附接到它的外表面。例如,可以采用生物相容性粘合剂来将基部710附接到可压缩层506。如图24所示,基部710限定轴线A-A,轴线A-A以角度α横切由杆状物712限定的轴线B-B。角度α为90°。在某些情况下,角度α大于90°。在其他情况下,α小于90°。
如图24所示,杆状物712从基部710的近侧端部部分突出。另选地,杆状物712可以从基部710的远侧端部部分突出。另选地,杆状物712可以从基部710的中心部分突出。如图22所示,基部712包括矩形形状。当可压缩附属物组件704与砧座84组装在一起时,矩形形状的基部710沿纵向狭槽86纵向地对准。本公开可设想到基部712的其他形状、尺寸和布置。在至少一种情况下,基部712可以包括圆形形状,并且杆状物714可以从圆形基部712的中心突出。
现在参见图25至图28,可压缩附属物组件804包括可压缩层806,该可压缩层附接到多个附接构件808。可压缩附属物组件804在许多方面类似于可压缩附属物组件504、604和704。例如,可压缩附属物组件804可以与外科缝合和切断器械的钳口构件例如外科缝合和切断器械8010的砧座84组装在一起。如下面更详细描述,附接构件808将可压缩层806可释放地附接到砧座84。
可压缩层806包括在第一可压缩部分806a与第二可压缩部分806b之间纵向地延伸的中间可压缩部分806c。多个狭槽809限定于中间可压缩部分806c中。狭槽809彼此间隔开并且沿可压缩层806的长度纵向地布置成一排。在某些情况下,狭槽809沿可压缩层806的中间可压缩部分806c的中心部分布置。在某些情况下,狭槽809沿中间可压缩部分806c的远侧部分和/或近侧部分布置。当可压缩附属物组件804与砧座84组装在一起时,狭槽809与细长狭槽86对准,使得切割刃9116在切割刃9116的远侧推进期间通过狭槽809。这减少了切割刃9116上的摩擦,这延长了切割刃9116寿命和/或减小了推进击发组件9090所需的力。
参见图25,附接构件808彼此间隔开并且沿中间可压缩部分806c的长度纵向地布置,使得附接构件808在由狭槽809限定的平面的两个侧814与816之间交替。本公开可设想到附接构件808相对于可压缩层806的其他位置和布置。每个附接构件808贴靠狭槽809定位。另选地,附接构件808可以定位在两个连续狭槽809之间。
附接构件808包括大体弯曲形状,这可以改善附接构件808的刚度。本公开可设想到其他形状。如图25所示,附接构件808包括部分圆柱形框架,该部分圆柱形框架具有背向狭槽809的凹入侧820和面朝狭槽809的凸入侧818。附接构件808还包括在附接部分808a与基部808b之间延伸的联接部分808c。附接部分808a包括侧向伸出部810,这些侧向伸出部被构造成能够抵靠内表面100’或内表面100”以将可压缩附属物组件804固定到砧座84。
除上述以外,基部808b还包括被构造成能够将附接构件808固定到可压缩层806的突片824。在至少一种情况下,如图26所示,基部808b包括单个突片824,该突片被接纳在可压缩层806的分叉部分826中。在至少一种情况下,如图27所示,基部808b包括两个突片824,该两个突片被构造成能够将可压缩层806的部分828接纳在该两个突片间。在至少一种情况下,如图28所示,基部808a包括突片824,该突片包括狭槽830。可以将可压缩层806的部分828扭转并插入狭槽830中以将附接构件808固定到可压缩层806。
现在参见图29,可压缩附属物组件904与砧座984组装在一起。砧座984在许多方面类似于砧座84(图9)和砧座8014(图1)。例如,砧座984包括细长狭槽86,该细长狭槽限定在细长狭槽86的第一侧90上延伸的第一外表面988,和在细长狭槽86的第二侧94上延伸的第二外表面992。另外,砧座984可相对于钉仓例如钉仓10000移动以将组织捕获在该砧座和钉仓间。砧座984的外表面988和992是阶梯式的,如图29所示。然而,在其他实施方案中,砧座可以包括非阶梯式的平面外表面。在至少一种情况下,砧座可以包括相对于两个侧向表面偏移的中心表面。本公开可设想到具有各种形状和表面的其他砧座。
在任何情况下,可压缩附属物组件904包括可贴靠第一外表面988定位的第一附接层908和可贴靠第二外表面992定位的第二附接层910。如图29所示,第一附接层908可释放地附接到第二附接层910。附接构件916和918分别从附接层908和916侧向地延伸。附接构件916和918分别包括互锁部分912和920,并且分别包括远侧端部部分914和922。远侧端部部分914和922分别褶卷在凸缘91和93下方,以将可压缩附属物组件904固定到砧座984,如图29所示。尽管示出了一对附接构件916和918,但应当理解,第一层908可以包括多个附接构件916,该多个附接构件可以与从第二层910延伸出的多个附接构件918互锁。
参见图30,互锁部分912和920可以分别包括互锁狭槽913和921,这些互锁狭槽可以被构造成用于彼此配对接合。在至少一种情况下,可以采用生物相容性粘合剂来增强狭槽913与921之间的接合。
参见图31至图34,附接层908和910由远侧端部部分930进一步连接,该远侧端部部分包括弯曲或卷绕突片932,该弯曲或卷绕突片卷起或插入砧座984的远侧端部中以将可压缩附属物组件904固定到砧座984。如图32所示,远侧端部部分930可由分别从层908和910延伸出的两个分离的端部部分934和936构成。端部部分934和936连接在一起形成远侧端部部分930。如图33所示,端部部分934和936可以包括燕尾形横向接合部938和用于与燕尾形横向接合部938配对接合的对应的燕尾形横向接合部940。本公开可以设想到用于将端部部分934和936附接形成远侧端部部分930的其他联接特征结构。
在图35和图36中示出了包括仓体1010和可植入附属物1030的钉仓组件1000。仓体1010包括仓平台或面向附属物的表面1013和限定于平台1013中的多个钉腔1015。钉仓组件1000还包括定位在钉腔1015中的多个钉1020和被构造成能够将钉1020驱动到钉腔1015外部的多个钉驱动器1011。每个钉1020都包括钉腿1021和该钉腿1021从其延伸的钉基部1023。在未击发状态下,钉1020储存在仓体1010内,使得钉腿1021越过或在仓平台1013上方部分地延伸到钉腔1015外部。当钉1020处于其未击发状态时,钉腿1021可以至少部分地延伸到可植入附属物1030中。可以设想其中当钉处于其未击发状态时,钉腿不延伸到仓平台1013上方的实施方案。
可植入附属物1030包括至少一个附接特征结构1031,该至少一个附接特征结构包括平台附接部分1033。每个附接特征结构1031都包括例如一体结构并且被构造成能够将可植入附属物1030可释放地固持或附接到仓平台1013。每个附接特征结构1031都横穿钉腔1015,使得当钉腔1015中的钉1020从钉腔1015部署时,附接特征结构1031由钉1020的钉基部1023接合、破裂和/或撕开,以将可植入附属物1030的一部分从仓平台1013释放。附接特征结构1031可以沿垂直于钉腔1015的方向,或以相对于钉腔的角度横穿腔1015。如图35和图36所示,附接特征结构1031横跨钉腔1015侧向地延伸。可以设想各种另选的实施方案,其中多个附接特征结构横穿每个钉腔1015使得钉1020的钉基部1023必需接合并克服多个附接特征结构以将附属物1030从仓平台1013释放。可以设想其他实施方案,其中一个附接部分横跨多个钉腔,需要多于一个钉接触和去除附接部分。
附接特征结构1031以任何合适的方式附接到附属物1030。在至少一种情况下,例如,附接特征结构1031包括编织成附属物1030的纤维。在至少一种此类情况下,附属物1030由交织纤维构成,并且附接特征结构1031交织成附属物1030。在某些情况下,附接特征结构1031利用至少一种粘合剂粘附到附属物1030。在至少一种此类情况下,附属物1030包括膜,并且附接特征结构1031粘合到该膜。在任何情况下,附接特征结构1031的平台附接部分1033可以以任何合适的方式附接到平台1013。在至少一种情况下,附接部分1033可以利用至少一种粘合剂粘附到平台1013。在某些情况下,可以加热附属物1030的附接特征结构1031,然后将它压靠平台1013,以便将平台附接部分1033附接到平台1013。
将附属物以上文所述的方式附接到仓,允许附属物的各个段保持附接到仓平台,直到捕获附属物的此类段的钉被部署为止。将附属物以这种方式附接到仓,还提供了多个不同的附接位置,这些附接位置在击发组件切入并缝合组织时逐渐被释放。例如,当击发组件从钉仓组件的近侧端部行进到钉仓组件的远侧端部时,在部署最远侧钉之前从钉仓部署最近侧钉,这因此在附属物的远侧端部之前释放附属物的近侧端部。换句话讲,附接特征结构,其尚未被它们相应的钉接合,在击发进展期间保持附接到仓平台,直到击发组件达到这些钉。
除上述以外,图36示出了接合附属物1030的附接特征结构1031并将该附接特征结构从仓平台1013释放之后的钉1020的钉基部1023。附接特征结构1031包括脱落部分,这些脱落部分被构造成能够一旦由钉基部1023向附接特征结构1031施加超出阈值力的力,就失效。在达到阈值力时,附接特征结构1031被构造成能够断开、撕裂和/或撕开,以便将附属物1030从仓平台1013释放。平台附接部分1033被构造成能够在附接特征结构1031断开时,保持附接到仓平台1013。可以设想其他实施方案,其中附接部分1033从仓平台1013脱离引起附属物1030从仓平台1013释放。在此类实施方案中,附接特征结构1031从仓平台1013中完全脱离。
除此之外或者作为替代,可以在附属物1030附接到平台1013之前,处理和/或清洁平台1013。此类处理和/或清洁可以改善附属物1030与平台1013之间的粘合。在至少一种情况下,使用表面活性剂、肥皂和/或润滑剂来促进将钉装入或插入钉腔,并且在这类情况下,可以筛选平台1013,或平台1013的至少一部分,以防止或抑制表面活性剂、肥皂和/或润滑剂流到平台1013上。例如,一种此类肥皂包括硬脂酸钠。在某些情况下,可以利用激光器、等离子体和/或IR加热来清洁平台1013,或平台1013的至少一部分,以便改善附接特征结构1031与平台1013之间的粘附力。
在图37和图38中示出了外科缝合组件1100。外科缝合组件1100包括砧座1160、钉仓组件1110和可植入附属物1130。钉仓组件1110包括仓体,该仓体包括多个钉腔1111和平台表面1113、可移除地储存在钉腔1111内的多个钉1120以及被构造成能够将钉1120向着外科缝合组件1100的砧座1160驱动到钉腔1111外部的多个钉驱动器1140。钉仓组件1110还包括滑动件1150,该滑动件被构造成能够将击发组件的线性运动转换成钉驱动器1140的竖直运动,以将钉1120驱动到钉腔1111外部。滑动件1150包括初始接触斜坡1151、中间接触表面1153和最终接触斜坡1155,它们全部被构造成能够在击发组件将滑动件1150从仓组件1110的近侧端部驱动到仓组件1110的远侧端部时,接触钉驱动器1140。
每个钉驱动器1140都包括三个或更多个部分:初始提升部分1143,该初始提升部分被构造成能够在滑动件1150朝远侧行进穿过仓体时,由滑动件1150的初始接触斜坡1151接合;底表面1145,该底表面被构造成能够由滑动件1150的中间接触表面1153和最终接触斜坡1155接合;以及顶部或钉支撑表面1141。在初始提升部分1143由滑动件1150的接触斜坡1151接合后,钉驱动器1140由中间接触斜坡1153,然后由滑动件1150的最终接触斜坡1155接触。滑动件1150的最终接触斜坡1155被构造成能够驱动钉驱动器1140,使得顶表面1141被驱动到仓平台表面1113上方。将钉驱动器1140的顶表面1141提升越过仓平台1113,允许钉驱动器1140将附属物1130和/或组织T提升远离仓平台表面1113。更具体地,将钉驱动器1140的顶表面1141提升越过仓平台1113,促使附属物1130的附接部分1131从仓平台1113脱离。
除上述以外,附接部分1131附接到限定于平台1113中的钉腔1111的中间的仓平台1113。在击发组件的纵向进展期间,附属物1130在附接部分1131处与仓体脱离接合。附接部分1131被构造成能够将附属物1130的对应部分从仓体逐渐地释放,一次一个附接部分1131。更具体地,当驱动器1140通过钉腔开口提升到仓平台1113上方时,如上所述,与钉腔开口相邻的附接部分1131被释放,从而将附属物1130的对应部分从仓平台1113释放,而定位在脱离的附接部分1131远侧的附接部分1131使附属物1130保持贴靠仓平台1113,直到后续驱动器1140提升到仓平台1113上方。
在很多情况下,储存在钉仓中的全部钉都从钉仓部署。在此类情况下,附属物1130在击发过程中由钉从平台1113完全释放。然而,在其他情况下,外科医生可以选择不从钉仓击发所有的钉。在此类情况下,尚未缝合到组织的剩余的附属物保持附接到仓平台1113。可以很容易将附属物的尚未缝合到组织的部分从附属物的已经缝合到组织的部分撕开或分离。附属物的尚未缝合到组织的部分保持附接到仓,以限制或消除留在患者体内的未缝合附属物的量。在各种情况下,附属物1130在最后一个驱动器的提升到仓平台1113上方的近侧撕裂。在各种其他情况下,附属物1130在最后一个驱动器的提升到仓1113上方的远侧撕裂。
除上述以外,还可以利用任何合适的方法形成附接部分1131。在至少一种情况下,可以利用激光熔融工艺来形成附接部分1131。在某些情况下,可以利用热熔工艺来形成附接部分1131。在至少一种情况下,可以利用离散的激光熔融来对编织成的纤维附属物的各部分进行预处理,使得这些纤维在附接部分1131变粘。无论用于形成附接部分1131的方式如何,附属物1130都可以在钉腔上方紧密地保持,使得充分的张力、剪切力和/或剥离力被施加到附接部分1131以将附属物1130从平台1113脱离。
在图39和图40中示出了外科缝合组件1200。外科缝合组件1200包括砧座1260、钉仓组件1210和可植入附属物1230。钉仓组件1210包括仓体,该仓体包括多个钉腔1211和平台表面1213、可移除地储存在钉腔1211内的多个钉1220以及被构造成能够将钉1220向着外科缝合组件1200的砧座1260驱动到钉腔1211外部的多个钉驱动器1240。钉仓组件1210还包括滑动件1250,该滑动件被构造成能够将击发组件的线性运动转换成钉驱动器1240的竖直运动,以将钉1220驱动到钉腔1211外部。滑动件1250包括初始接触斜坡1251和最终接触斜坡1253,该初始接触斜坡和该最终接触斜坡被构造成能够在击发组件将滑动件1250从仓组件1210的近侧端部驱动到仓组件1210的远侧端部时,接触钉驱动器1240。
钉驱动器1240包括:一,初始提升部分1243,该初始提升部分被构造成能够在滑动件1250朝远侧行进穿过仓体时,由滑动件1250的初始接触斜坡1251接合,以引发驱动器1243的提升;二,底表面1245,这些底表面被构造成能够由滑动件1250的最终接触斜坡1253接触;以及三,顶部或钉支撑表面1241。钉1220的腿偏压抵靠钉腔1211的侧壁以将钉1220保持在钉腔1211中。钉1220的腿包括钉尖端1221,这些钉尖端具有带倒钩的构型,该构型被构造成能够将附属物1230可释放地保持或固持到仓体。因此,附属物1230由钉1220的钉尖端1221固持到仓平台1213,直到钉1220被驱动到钉腔1211外部为止。当钉1220被驱动到钉腔1211外部时,并且由于倒钩之间的交互作用,附属物1230能够在钉尖端1221朝向砧座1260移动时,随着钉1220一起行进。钉尖端1221的带倒钩的构型允许附属物1230从仓平台1213逐渐地释放。
钉尖端1221被构造成能够将附属物1230以与上述类似的方式从仓平台1213逐渐地释放。当近侧钉1220从仓体射出时,远侧钉1220将附属物1230抵靠仓平台1213保持。在临床医生决定在仅部分地击发钉仓之后从缝合部位移开外科缝合器械的情况下,尚未缝合到组织的剩余的附属物保持附接到仓平台1213。可以将附属物的尚未缝合到组织的部分从附属物的已经缝合到组织的部分撕开或分离。附属物的尚未缝合到组织的部分保持附接到仓,以限制或消除留在患者体内的未缝合附属物的量。在各种情况下,例如,附属物1230可以包括穿孔或不连续部分,这些穿孔或不连续部分被构造成能够允许毫无困难地撕裂附属物1230。例如,这些穿孔可以定位在每个钉腔1211之间。
除上述以外,例如,钉1220的钉腿可以具有第一组倒钩,该第一组倒钩被构造成能够在钉1220处于其未击发位置时,接合附属物1230。当钉1220正被击发时,第一组倒钩可以离开附属物1230。当第一组倒钩离开附属物1230时,第二组倒钩可以进入附属物1230。当钉1220处于其击发位置时,第二组倒钩可以与附属物1230接合。在至少一种情况下,例如,第一组倒钩可以包括两个倒钩,而第二组倒钩可以包括两个倒钩。无论所使用的倒钩的数量如何,第一组倒钩可以在钉1220处于其未击发位置时,定位在仓体的平台1213上方,而第二组倒钩可以在钉1220处于其未击发位置时,定位在平台1213的顶表面下方。
如图40所示,倒钩侧向向外延伸;然而,倒钩可以沿任何合适的方向,例如侧向向内延伸。除此之外或者作为替代,钉腿可以包括向内延伸以抓持附属物的尖端部分。
在图41中示出了钉仓组件1300。钉仓组件1300,其被构造用于与外科缝合器械一起使用,包括可植入附属物或材料1310和钉仓体1301。钉仓包括多个平台特征结构,诸如被构造成能够将多个钉可移除地储存于其中的钉腔1303,以及此外,被构造成能够接纳穿过其的击发组件的狭槽1305。可植入附属物1310通过热成形附接、固定和/或附连到仓体1301。例如,将仓体1301加热到具体温度,然后将可植入附属物1310压靠到仓体1301上、仓体中和/或贴靠仓体。在与仓体1301接合时,可植入附属物1310形成或模制到仓体1301的平台特征结构中,从而提供附接特征结构1311,这些附接特征结构被构造成能够允许附属物1310从仓体1301的逐渐释放。类似地,附属物1310的部分1315可以与狭槽1305的构型适形。部分1315可以沿整个狭槽1305或狭槽1305的一部分延伸。在至少一种情况下,例如,部分1315仅定位在狭槽1305的近侧端部。例如,钉仓组件1300的一个优点可以包括具有更复杂形状的可植入附属物,该可植入附属物与对应的钉仓定制配合,同时维持更简单的制造过程。
在至少一个实施方案中,除上述以外,可以将钉装载到仓体1301中以形成子组件,然后将该子组件加热到高于、处于或接近材料或者包括附属物1310的材料的玻璃化转变温度的温度。在至少一种情况下,例如,将子组件加热到约105摄氏度。然后,将附属物1310放置在仓体1301上。此时,附属物1310未被加热或在室温下;然而,可以设想的是,可以预热附属物1310。然后将附属物1310向下推动到仓体1301上,因此仓体1301将附属物1310加热到高于、处于或接近材料或者包括附属物1310的材料的玻璃化转变温度的温度。在至少一种情况下,例如,附属物1310是由PGA和/或PLA构成的泡沫。由于泡沫被加热到高于、处于或略微低于PGA和/或PLA的玻璃化转变温度的温度的事实,泡沫可以在仓体1301的特征结构和/或定位在其中的钉的周围具有新的永久形状。例如,仓体1301可以包括从平台延伸出的突出部,并且当附属物1310被推到加热的平台突出部上时,附属物1310可以围绕平台突出部永久地变形。在这类情况下,附属物1310紧紧地抓持平台突出部,直到附属物1310由钉推到突出部外部。类似地,附属物1310可以围绕加热的钉腿永久地变形并紧紧地抓持加热的钉腿。在至少一种情况下,例如,新形成的孔的直径可以比钉腿的直径小约10%。在任何情况下,可以在任何合适的时间去除施加到附属物1310的压力。在至少一种情况下,向附属物1310施加压力,直到仓体1301、钉和附属物1310的温度远低于或至少低于包括附属物1310的材料的玻璃化转变温度。另选地,当钉仓组件1300的温度处于或高于包括附属物1310的材料的玻璃化转变温度时,可以去除压力。
图42至图44示出了又一个外科缝合组件1400。外科缝合组件1400包括砧座1460、钉仓组件1410和可植入附属物1430。钉仓组件1410包括仓体,该仓体包括多个钉腔1411、平台表面1413和狭槽1415。钉仓组件1410还包括可移除地储存在钉腔1411内的多个钉1420以及被构造成能够将钉1420向着外科缝合组件1400的砧座1460驱动到钉腔1411外部的多个钉驱动器1440。钉仓组件1410还包括滑动件1450,该滑动件被构造成能够将击发组件的线性运动转换成钉驱动器1440的竖直运动,以将钉1420驱动到钉腔1411外部。滑动件1450包括:驱动器斜坡1451,这些驱动器斜坡被构造成能够接触并将钉驱动器1440朝向砧座1460驱动;以及,此外,释放部分1453,该释放部分被构造成能够将附属物1430从平台1413脱离。
释放部分1453包括延伸到平台表面1413的一部分上方的侧向凸缘。更具体地,侧向凸缘在平台表面1413上方在狭槽1415与内排钉腔1411延伸。附属物1430包括附接部分1431,这些附接部分被构造成能够将附属物1430可释放地固持到仓平台1413,直到滑动件1450的释放部分1453接合附接部分1431。当击发组件前进穿过钉仓组件1410时,释放部分1453可以例如充当犁形部件,该犁形部件被构造成能够在释放部分1453接合附接部分1431时犁沟、切割、切入和/或切开附接部分1431。当击发组件从仓体的近侧端部朝向仓体的远侧端部横贯仓体时,附接部分1431逐渐接合。
现在转向图45,示出了钉仓组件1500。钉仓组件1500包括仓体1510,该仓体包括仓平台1513、附接特征结构1515、平台特征结构1517和狭槽1519。钉仓组件1500还包括多个钉1520和由附接特征结构1515可释放地固持到仓平台1513的可植入附属物1530。当钉1520从钉仓1510射出时,平台特征结构1517引导钉1520。平台特征结构1517还限制附属物1530在由采用了钉仓组件1500的外科器械所捕获的组织的夹持和/或切割期间的运动。
例如,附接特征结构1515包括倒钩。每个倒钩1515都包括被构造成能够穿刺附属物1530的锋利的尖端和被构造成能够抑制倒钩1515退出附属物1530的保持肩部。倒钩1515可以在任何合适的位置从平台1513延伸出。例如,倒钩1515可以在仓体1510的相对侧上被布置成纵向排。在这类情况下,附属物1530可以保持在倒钩1515的纵向排之间。附属物1530可以在倒钩1515的这些排之间保持绷紧、张紧或拉伸,这可以促进穿过纵向狭槽1519的击发组件的切割构件对附属物1530的横切。当切割构件横切附属物1530时,附属物1530内的张力被释放。此外,附属物1530的被横切的部分可以响应于附属物1530内的张力的释放而远离纵向狭槽1519侧向向外移动或迁移。被横切的附属物部分的此类运动可以引起被横切的附属物部分至少部分地从倒钩1515脱离。在至少一种情况下,倒钩1515的保持肩部侧向向外,使得附属物部分的侧向向外运动倾向于将附属物部分从倒钩1515释放。
如上所述,可以制造附属物然后将其组装到钉仓。现在转向图46至图48,钉仓组件1600包括仓体1610,该仓体包括钉腔1611和限定于该钉腔中的纵向狭槽1613。钉仓组件1600还包括在仓体1610直接制造的可植入附属物。如图46所示,可植入材料1630可以分配在仓体1610的平台上。在各种情况下,例如,可植入材料可以包括熔喷非编织材料。例如,在图47中示出了这种情况。在至少一个实施方案中,利用静电纺丝来将聚合物材料熔喷到仓体1610上。在至少一个此类实施方案中,例如,聚合物材料被加热到超出聚合物材料的玻璃化转变温度的温度。在某些实施方案中,聚合物材料是溶液的一部分。在任一种情况下,聚合物材料是可流动的并且朝向仓体1610加速。聚合物材料由例如机械纺丝构件诸如喷丝头加速,和/或通过在聚合物材料与目标之间施加压差来加速。在各种情况下,聚合物材料是带电的。在至少一种情况下,聚合物材料包括嵌入其中的一种或多种磁性材料。例如,目标可以包括仓体1610和/或定位在仓体1610后面的金属板。
在一些情况下,除上述以外,熔喷非编织材料在其分配在仓体1610上之后,在仓体1610的边缘之上延伸。参见图48,可以将此类多余的材料修剪成使得材料1630的边缘与仓体1610的边缘对准,或基本上对准。一旦熔喷非编织材料的温度已充分冷却,就可以发生此类修剪。
除上述以外,还可以使用熔喷非编织材料来制造不直接形成在仓体上的可植入附属物。在至少一种此类情况下,将聚合物材料加热并喷到腔或模具中以形成可植入附属物。在聚合物材料充分冷却后,可以将聚合物材料修剪成合适的尺寸。除此之外或者作为替代,可以向仓体施加熔喷非编织材料以将可植入附属物粘附到仓体。在这类情况下,例如,可以将附属物压到熔喷非编织材料上,同时该材料仍至少部分地熔融。
现在转向图49,钉仓组件2000包括仓体2010和可植入层2030。仓体2010包括平台2011和限定于平台2011中的多个钉腔2012。层2030与平台2011相邻并且在钉腔2012之上延伸。钉2020被可移除地定位在每个钉腔2012中。每个钉腔2020都可由击发构件和/或钉驱动器系统从未击发位置移动到击发位置。如图49所示,当钉2020处于其未击发位置时,钉2020的尖端2021延伸到平台2011上方并且部分地嵌入在层2030中;然而,可以设想其中尖端2021不延伸到平台2011上方并且不嵌入在层2030中的其他实施方案。当钉2020从钉腔2012射出时,钉2020将层2030的各部分捕获在其中并抵靠患者组织T植入层2030,如图50所示。
层2030由多个第一纤维和多个第二纤维构成。第一纤维由第一材料构成,并且第二纤维由与第一材料不同的第二材料构成。第一材料具有第一热转变温度,在该第一热转变温度中第一材料改变状态。第二材料具有第二热转变温度,在该第二热转变温度中第二材料改变状态。在至少一种情况下,第一材料具有第一玻璃化转变温度,并且第二材料具有与第一玻璃化转变温度不同的第二玻璃化转变温度。当第一材料超出其玻璃化转变温度时,第一纤维将收缩。类似地,当第二材料超出其玻璃化转变温度时,第二纤维将收缩。纤维的收缩包括其最长长度的缩短。更具体地,纤维通常包括具有弯曲和/或扭转形状的股线,并且当股线被加热到高于其玻璃化转变温度时,股线的形状将倾向于变得更弯曲和/或扭转,这缩短了其最长长度,尽管股线的总长度没有改变。在这类情况下,纤维的构型将变得不那么组织化。
层2030的第一纤维和第二纤维可以任何合适的工艺混合。在至少一种工艺中,例如,第一纤维和第二纤维可以交织。例如,第一纤维可以被编织成网状物,并且第二纤维可以被交织成网状物。在纤维已适当地混合后,可以将纤维暴露于热量。这些纤维被加热到高于第一热转变温度但低于第二热转变温度的温度。因此,第一纤维收缩而第二纤维不收缩,或至少它们没有大幅收缩。尽管如此,第一纤维的收缩将使第二纤维收缩并改变层2030的整体形状。更具体地,收缩的第一纤维会将层2030的边缘向内拉动。这些边缘的此类向内运动可以增大层2030的厚度2031。在某些情况下,层将变得蓬松和/或聚成一团。在任何情况下,本文所述的加热工艺都可允许层2030呈现这样一种构型,其可以补偿钉中所捕获的组织厚度的变化。
层2030的第一材料和第二材料可以包括任何合适的材料。例如,第一材料为第一聚合物,并且第二材料为第二聚合物。例如,第一材料为聚二氧六环酮(PDS),并且第二材料为聚乙醇酸(PGA),诸如由Ethicon,Inc.制造的VICRYL。与具有较低热转变温度的第一材料相比,层2030包含更多的具有较高热转变温度的第二材料。在至少一个示例中,VICRYL(即,第二材料)与PDS(即,第一材料)的比为约7:1。在至少一个其他示例中,VICRYL(即,第二材料)与PDS(即,第一材料)的比为约5:1。其他比和材料也是可能的。
除上述以外,可以设想其中层2030被加热到处理温度使得第一纤维被加热到高于其热转变温度并且第二纤维也被加热到高于其热转变温度的各种另选的实施方案。在其中第一热转变温度低于第二热转变温度的至少一种此类情况下,第一纤维将比第二纤维收缩更多。
在层2030已经被加热以达到其如本文所述的期望性质之后,层2030被冷却和/或被允许冷却到低于第一热转变温度和第二热转变温度。层2030在组装到仓体2010之前,被冷却到低于第一热转变温度和第二热转变温度。
在各种另选的实施方案中,现在转向图57,钉仓组件2300的层2330被加热到高于第一热转变温度和第二热转变温度中的至少一个的温度,然后贴靠仓组件2300的仓体2310定位和/或压靠。然后将层2330冷却和/或允许它冷却。
除上述以外,仓体2310包括平台2311和限定于平台2311中的钉腔2312。仓体2310还包括从平台2311向上延伸的柱形件2315。当加热层2330压靠平台2311时,层2330可以与仓体2310的特征结构适形。例如,层2330的各部分可以楔进钉腔2312中并且可以呈现钉腔2312的形状以形成突出部2332。类似地,层2330的各部分可以围绕柱形件2315形成并且呈现柱形件2315的形状以形成开孔2335。另外,类似地,层2330的各部分可以楔进仓体2310的纵向刀狭槽2314中以形成突片2334。
除上述以外,加热层2330与仓体2310之间的初始对准将确定在层2330的底部如何形成这些特征结构。仓体2310包括一个或多个基准,该一个或多个基准可以有助于层2330与仓体2310之间的正确对准。仓体2310包括从仓体2310的近侧端部向上延伸的对准止挡件2318,可以利用这些对准止挡件来将层2330的近侧端部2338与仓体2310的近侧端部对准。
现在转向图52,第一纤维2231和第二纤维2232缠绕或交织。当纤维2231和2232暴露于热量Q时,第一纤维2231变得不那么无组织并且开始沿其最长维度收缩,如图52所示。如图52所示,第一纤维2231相对于第二纤维2232收缩。当第一纤维2231沿其最长维度收缩时,参见图53,第一纤维2231沿侧向方向伸展。因此,纤维2231、2232的组件可以变得有弹性并且可以在载荷下改变形状。
纤维2231和2232在层内的布置可以是随机的。在某些情况下,纤维2231和2232在层内的布置可以至少部分地组织化。现在转向图55,层2230包括第二纤维2232的网状物。第二纤维2232在节点2235处彼此附接或交织;然后,可以设想其中第二纤维2232不彼此附接的各种实施方案。第二纤维2232被布置成沿纵向轴线2233和侧向轴线2234延伸的格栅或网状物。轴线2233和2234彼此正交或基本上正交;然而,可以设想其中第二纤维2232的格栅不沿轴线的已组织阵列布置的其他实施方案。第一纤维2231交织到第二纤维2232的网状物中。当层2230暴露于超出第一材料的第一热转变温度的温度时,第一纤维2231收缩,如图56所示。因此,层2230呈现侧向扩展构型,称为层2230’。
现在转向图51,层组件2130包括第一层2131、第二层2132和第三层2133。第一层2131包括相互交织的多个第一纤维2134和多个第二纤维2135。类似地,第三层2133包括相互交织的多个第一纤维2134和多个第二纤维2135。类似于上述,第一纤维2134由具有第一热转变温度的第一材料构成,并且第二纤维2135由具有与第一热转变温度不同的第二热转变温度的第二材料构成。第二层2132定位在第一层2131和第三层2133的中间。第二层2132由膜构成;然而,可使用任何合适的材料。例如,可以利用一种或多种粘合剂来将第一层2131和第三层2133附接到第二层2132。第二层2132将第一层2131与第三层2133分开。在各种情况下,第二层2132可以允许第一层2131和第三层2133彼此独立地收缩。
在各种情况下,除上述以外,可以利用任何合适的过程来移除和/或修改层的各部分。再次参见图57,例如,可以利用层切割工艺在层2330中产生一个或多个纵向狭缝2337。桥接部2336限定于狭缝2337的中间并将层2330的两个侧向半部固持在一起。
现在转向图58,端部执行器组件2400包括钉仓体2410和砧座2490。仓体2410包括平台2411、纵向刀狭槽2414和限定于狭槽2414的相对侧上的纵向排钉腔。更具体地讲,第一纵向排钉腔2412a设置在纵向狭槽2414的每一侧上,第二纵向排钉腔2412b相对于每个第一排钉腔2412a侧向地设置,并且第三纵向排钉腔2412c相对于每个第二排钉腔2412b侧向地设置。第一钉2020a可移除地储存在每个第一钉腔2412a中,第二钉2020b可移除地储存在每个第二钉腔2412b中,并且第三钉2020c可移除地储存在每个第三钉腔2412c中。
除上述以外,第一钉2020a各自具有第一未成形高度,第二钉2020b各自具有第二未成形高度,并且第三钉2020c各自具有第三未成形高度。第一未成形高度比第二未成形高度更短,并且第二未成形高度比第三未成形高度更短。可以设想其中第一钉2020a、第二钉2020b和/或第三钉2020c具有相同的未成形高度的其他实施方案。2012年11月27日公布的名称为“SURGICAL STAPLING DEVICES THAT PRODUCE FORMED STAPLES HAVING DIFFERENTLENGTHS”的美国专利8,317,070全文以引用方式并入本文。砧座2490包括与钉腔2412a对准的第一纵向排成形凹坑2492a、与钉腔2412b对准的第二纵向排成形凹坑2492b和与钉腔2412c对准的第三纵向排成形凹坑2492c。钉2020a、2020b和2020c由定位在仓体2410中的多个钉驱动器从钉腔2412a、2412b和2412c射出,该多个钉驱动器将钉2020a、2020b和2020c提升成分别与成形凹坑2492a、2492b和2492c接触。
除上述以外,定位在仓体2410和砧座2490的成形凹坑2492a、2492b和2492c中的钉驱动器被构造成能够使钉2020a、2020b和2020c变形到不同的成形高度。更具体地,第一钉2020a变形到第一成形高度,第二钉2020b变形到比第一成形高度更高的第二成形高度,并且第三钉2020c变形到比第二成形高度更高的第三成形高度。图59示出了这种布置。可设想到其中第三成形高度与第二成形高度相同的其他实施方案。
除上述以外,再次参见图58,仓体2410的平台2411还包括倾斜支撑表面。平台2411的沿第一纵向排钉腔2412a延伸的部分高于平台2411的沿第二纵向排钉腔2412b延伸的部分。类似地,平台2411的沿第二纵向排钉腔2412b延伸的部分高于平台2411的沿第三纵向排钉腔2412c延伸的部分。平台2411包括弧形表面。在各种情况下,平台2411的倾斜支撑表面可以包括独立的阶梯式表面。例如,平台2411可以包括沿第一排钉腔2412a延伸的第一纵向台阶、沿第二排钉腔2412b延伸的第二纵向台阶和/或沿第三排钉腔2412c延伸的第三纵向台阶。平台2411还可以包括第一台阶和第二台阶中间的和/或第二台阶和第三台阶中间的倾斜表面。
除上述以外,砧座2490还包括阶梯式组织补偿表面。例如,第三纵向排成形凹坑2492c限定于纵向台阶中。在另选的实施方案中,砧座2490包括平坦的组织补偿表面。在任一种情况下,当端部执行器2400处于夹持构型时,定位在仓体2410与砧座2490之间的组织被压缩到两者间的合适压力,如图58所示。然而,此类组织压缩在端部执行器2400内不是均匀的。例如,与第一排钉腔2412a相邻的组织被压缩到第一压力,与第二排钉腔2412b相邻的组织被压缩到小于第一压力的第二压力,并且与第三排钉腔相邻的组织被压缩到小于第二压力的第三压力。可以设想到其他布置。
端部执行器2400还包括定位在平台2411上的可植入层2430。例如,第一层2430定位在纵向狭槽2414的第一侧上,并且第二层2430定位在纵向狭槽2414的第二侧上。层2430限定两者间的纵向狭槽,该纵向狭槽与限定于仓体2410中的狭槽2414和限定于砧座2490中的纵向狭槽2494对准,或至少基本上对准。仓狭槽2414、层狭槽和砧座狭槽2494被构造成能够允许击发构件纵向地移动穿过端部执行器2400。在另选的实施方案中,定位在平台2411上的层不包括层狭槽,并且当击发构件朝远侧移动时,击发构件的切割部分横切该层。
本文所述的可植入层可由交织在一起的纤维构成。例如,在图60和图61中示出了纤维3000。每个纤维3000都包括已经塑性地变形且包括限定于其中的一个或多个扭结的股线。可植入层,诸如图63所示的包括纤维3000的层3030,是弹性的并且可以补偿钉3020内所捕获的组织厚度的变化。纤维3000被编织在一起形成可以充当总距弹簧的可植入层。此外,层3030的纤维3000由于它们的扭结构型而是柔软的,并且与先前的不包括纤维3000的可植入层(例如,图62所示的层3130)相比,不太可能磨蚀组织T。
纤维3000可以任何合适的方式制造。在各种情况下,制造工艺可以利用用于在纤维3000中机械地和/或用热的方法形成扭结和/或以其他方式使纤维3000塑性地变形的任何合适的装置。现在转向图65,可以利用加热模具来使股线3000’塑性地变形以形成连续纤维3000。加热模具包括第一侧和第二侧3050,其中这些侧中的至少一个侧可在打开位置与闭合位置之间相对于另一侧运动。图65示出了处于打开构型的加热模具。当模具处于其打开构型时,未成形股线3000'的一部分定位在模具中在开口侧3050之间。在至少一种情况下,制造工艺包括卷轴3060,该卷轴被构造成能够将股线3000’拉到模具中。模具的每一侧3050都包括加热表面3051。加热表面3051包括多个突出部,该多个突出部被构造成能够接触股线3000’,并且通过机械压力和/或加热来使股线3000’塑性地变形。此时,连续股线3000’变成包在卷轴3060周围的连续纤维3000。如果需要,可以在制造工艺的后续步骤期间横切连续纤维3000。
除上述以外,现在转向图66,制造工艺包括一个或多个可旋转模具3350。每个模具3350都可围绕轴线3352旋转并且包括围绕模具3350延伸的多个齿状物3351。可旋转模具3350的齿状物3351互相啮合,并且当股线3000’通过互相啮合的齿状物3351时,使连续股线3000’变形成连续纤维3000。类似于上述,将模具3350加热并向股线3000’施加热量(Q)。现在转向图67,制造工艺包括可旋转模具3450。模具3450可围绕轴线3452旋转并且包括从其中延伸出的齿状物3451。连续股线3000’包在模具3450的周长周围并与齿状物3451接合。加热齿状物3451,并且当齿状物3451接触股线3000’时,股线3000’变成连续扭结纤维3000。可以向纤维3000施加张力以围绕模具3450拉动纤维3000。
除此之外或者作为替代,纤维3000可以任何合适的方式变形或扭结。在各种情况下,例如,可以使用空气变形和/或任何其他合适的变形形式。此外,可以利用纤维3000中的变形或扭结之间的间隔来控制纤维3000的性质。在变形或扭结之间具有较短间隔的纤维3000将比在变形或扭结之间具有较长间隔的纤维3000刚度更小。无论用于使纤维3000变形的变形方式如何,纤维3000都可以包括任何合适的横截面。在至少一种情况下,股线3000’可以包括圆形的,或至少基本上圆形的横截面,该横截面在股线3000’已变形或扭结以形成纤维3000后,至少部分地变平。在各种情况下,例如,纤维3000具有其中它们已变形的扁圆横截面。
除上述以外,纤维3000可以在用于形成可植入层的制造过程的一个或多个步骤期间经历变形或扭结过程。在至少一个过程中,纤维3000在它们在初始编织过程中编织在一起之前变形或扭结。例如,此类变形过程可以利用压力和/或热量。另选地,纤维在初始编织过程之前不经历变形过程。在任一种情况下,一旦纤维3000编织在一起,就将它们解开。编织和解开纤维3000的过程使纤维3000变形或扭结。在已解开纤维3000后,它们可能会与可能不会经历变形或扭结过程。例如,此类变形过程可以利用压力和/或热量。在纤维3000经历适当数量的预扭结过程之后,然后将纤维3000重新编织成可植入层。
在各种情况下,除上述以外,例如,仅利用预扭结纤维3000来编织可植入层,而在其他情况下,将预扭结纤维3000与其他纤维诸如未扭结纤维混合。在至少一种情况下,编织成的可植入层包括由材料构成的第一组预扭结纤维3000和由相同材料构成的第二组预扭结纤维。在另一种情况下,编织成的可植入层包括由第一材料构成的第一组预扭结纤维3000和由与第一材料不同的第二材料构成的第二组预扭结纤维。在又一种情况下,编织成的可植入层包括以第一间隔扭结的第一组预扭结纤维3000和以与第一间隔不同的第二间隔扭结的第二组预扭结纤维。由具有较高刚度的第一组纤维与具有较高刚度的第二组纤维交织构成的可植入层(例如本文所述的那些)可以为可植入层提供期望的弹性模量。
可以将本文所述的变形扭结纤维以任何合适的方式编织成可植入层。在各种情况下,可以将可植入层编织成使得它不包括接缝。现在转向图68,可以将植入层3530编织或扭结成使得它包括接缝。可植入层3530包括顶表面3531、底表面3532以及沿侧向接缝3533、纵向接缝3534和内部接缝3535彼此连接的交织纤维。参见图69,层3530由纤维3000以及(除此之外)纤维3500构成。参见图70,纤维3000和3500交织形成接缝3533、3534和3535。
接缝3533、3534和3535可以以期望密度交织以实现期望结果。例如,纵向接缝3534的密度在层3530的侧向侧比在层3530的中部更高。当层3530定位在钉仓上并插入缝合器械中时,层3530的中部与缝合器械的切割构件对准。由于层3530的与切割构件对准的中部的较低密度,层3530可以更容易地被切割构件横切,同时允许层3530在由钉捕获的区域中具有不同的密度。另外,例如,侧向接缝3533的密度在层3530的中部比在层3530的近侧端部和远侧端部更高。由于层3530的近侧端部的较低密度,切割构件可以更容易地开始其对层3530的横切。类似地,层3530的远侧端部的较低密度可在切割构件在其行程末期减速时,协助切割构件完成其切割。
在图64中示出了层3230。层3230包括顶部部分3231、底部部分3232和将顶部部分3231和底部部分3232相连的中间部分3233。中间部分3233将顶部部分3231相对于底部部分3232隔开并定位。部分3231、3232和3233由扭结纤维3000构成。纤维3000被组织或编织到侧向接缝3233和纵向接缝3234中。与层3230侧向部分相比,纵向接缝3234的密度在层3230的中间部分更高。
除上述以外,现在转向图71和图72,钉仓3600包括仓体3610和可植入层3630。仓体3610包括被构造成能够支撑层3630的平台3611。层3630包括顶表面3631、底表面3632,并且由纤维3633构成。纤维3633的密度3634在层3630的中间比层3630的侧向侧更高。事实上,纤维3633的较高密度3634与限定于仓体3610中的纵向狭槽3614对准,该纵向狭槽被构造成能够接纳击发构件的切割部分。在层3630的中部,纤维3633的较高密度3634减少层3630相对于仓体3610的屈曲或运动。
现在转向图73,可植入层3730包括顶表面3731、底表面3732和由交织纤维构成的主体。这些纤维被编织到侧向接缝3733和纵向接缝3734中。这些纤维在编织点3735彼此互连。编织点3735将在可植入层3730内侧向地和/或纵向地延伸的纤维连接。编织点3735可以在侧向接缝3733内将纤维连接。编织点3735可以在纵向接缝3734内将纤维连接。编织点3735可以在纵向接缝3734内将侧向接缝3733连接。可植入层3730中的编织点3735的密度可以控制可植入层3730的弹性或弹力。层3730的具有较高编织点密度的部分可以比层3730的具有较低编织点密度的部分弹性更小。关于图73所示的实施方案,层3730的侧向部分具有高的编织点密度,而层3730的中间部分具有低的编织点密度;然而,可以利用编织点密度的任何合适的布置。
现在转向图74,可植入层3830包括顶表面3831、底表面3832和由交织纤维构成的主体。这些纤维被编织到侧向接缝3833和纵向接缝3834中。这些纤维在编织点3835彼此互连。编织点3835将在可植入层3830内侧向地和/或纵向地延伸的纤维连接。编织点3835可以在侧向接缝3833内将纤维连接。编织点3835可以在纵向接缝3834内将纤维连接。编织点3835可以在纵向接缝3834内将侧向接缝3833连接。
在各种情况下,除上述以外,交织成可植入层的纤维可以具有相同的直径和/或长度。在其他情况下,纤维可以具有不同的直径和/或长度。再次参见图74,可植入层3830的某些纤维具有第一直径或厚度,而其他纤维具有大于第一直径的第二直径或厚度。较薄的纤维位于可植入层3830的中间,而较厚的纤维位于可植入层3830的侧向侧。当外科缝合器械的切割构件通过可植入层3830的中心时,较薄的纤维可以促进可植入层3830的切割。另选地,较厚的纤维位于可植入层3830的中间,这可以抑制层3830屈曲。
现在转向图75和图76,可植入附属物4030包括多个层。附属物4030包括第一外部层4031和第二外部层4035。第一外部层4031由交织纤维构成。类似地,第二外部层4035由交织纤维构成。例如,外部层4031、4035的纤维可由任何合适的材料诸如VICRYL和/或本申请中所描述的任何材料构成。附属物4030还包括中间层4033。中间层4033也由交织纤维构成。中间层4033可由与外部层4031、4035相同的材料和/或不同的材料构成。
再次参见75和图76,附属物4030还包括第一粘合层4032和第二粘合层4034。第一粘合层4032定位在第一外部层4031和中间层4033的中间。第二粘合层4034定位在第二外部层4035和中间层4033的中间。第一粘合层4032由具有与包括层4031、4033和4035的材料相比更低熔融温度的材料构成。类似地,第二粘合层4034由具有与包括层4031、4033和4035的材料相比更低熔融温度的材料构成。
除上述以外,将附属物4030的层4031、4032、4033、4034和4035以图75所示的方式堆叠。然后,加热附属物4030。将附属物4030加热成使得粘合层4032和4034的温度等于或超出包括粘合层4032和4034的材料的熔融温度。当粘合层4032和4034由相同材料构成时,粘合层4032和4034将以相同的温度熔融。可以将这个温度称为阈值熔融温度。当第一粘合层4032由具有第一熔融温度的第一材料构成并且第二粘合层4034由具有第二或不同熔融温度的第二材料构成时,层4032、4034中的一个层将在另一个层之前熔融。在这类情况下,阈值熔融温度包括第一熔融温度和第二熔融温度中的较高者。
当粘合层4032、4034正在熔融时,熔融材料穿透第一外部层4031、中间层4033和/或第二层4035。熔融层4032、4034穿透层4031、4033、4035的量可以取决于几个因素。例如,层4031、4033和/或4035可由交织纤维构成,并且熔融层4032、4034穿透纤维编织物的量可以取决于纤维编织物的开度。例如,与更闭合或更紧的编织物相比,熔融层4032、4034可以更深地穿透更开或更松散的编织物。换句话讲,熔融层4032、4034可能不会充分地穿透紧密针织的编织物。第一外部层4031和第二外部层4035具有相同的或至少基本上相同的编织密度。在各种另选的实施方案中,第一外部层4031和第二外部层4035具有不同的编织密度。在至少一个此类实施方案中,现在转向图77,另选的附属物4030”的第二外部层4035”具有比第一外部层4031”更紧的编织物。与第二粘合层4034”可以穿透第二外部层4035”相比,第一粘合层4032”可以更深地或更充分地穿透第一外部层4031”。
再次参见图75,附属物4030的中间层4033包括限定于中间层中的开孔4036。开孔4036包括通孔。熔融的粘合层4032、4034可以进入开孔4036以改善或增加粘合层4032、4034与中间层4033之间的粘合。在另选的实施方案中,开孔4036可能不会完全延伸穿过中间层4033。这就是说,此类开孔4036可以充分深以接纳足够量的熔融材料,从而与粘合层4032、4034形成充分的粘合。第一外部层4031和/或第二外部层4035可以包括限定于所述外部层中的开孔以改善或增加它们分别与第一粘合层4032和第二粘合层4034的粘合。
如上所述,将附属物4030加热以熔融,或至少基本上熔融粘合层4032、4034。另外,如上所述,粘合层4032、4034的熔融部分流入层4031、4033和/或4035中。在附属物已充分加热后,附属物4030冷却和/或被允许冷却。例如,可以将附属物4030放置于致冷单元中,布置在露天中,和/或暴露于空气流。当附属物4030冷却到低于阈值熔融温度时,熔融的粘合层4032、4034可以开始固化,从而将层4031、4032、4033、4034和4035锁定在一起。在各种情况下,熔融的粘合层4032和4034可以呈现与层4031、4033和4035的机械互锁构型,如图76所示。
除上述以外,附属物4030的层4031、4033和4035由熔融温度大于粘合层4032和4034的阈值熔融温度的材料构成。此外,层4031、4033和4035由熔融温度大于附属物4030所暴露于的最高处理温度的材料构成。因此,当粘合层4032和4034正熔融时,层4031、4033和4035不会熔融。在至少一种情况下,层4031、4033和4035由例如VICRYL构成,并且粘合层4032和4034由例如PDS构成。在至少一种此类情况下,例如,粘合层4032和4034由PDS膜构成。
在各种实施方案中,除上述以外,每个粘合层4032、4034都可由两种或更多种材料构成。在某些情况下,每种包括粘合层4032、4034的材料的熔融温度都等于或低于附属物4030的最大处理温度。在其他情况下,一些包括粘合层4032、4034的材料的熔融温度等于或低于最大处理温度,而其他材料的熔融温度高于最大处理温度。在此类实施方案中,层4032和4034的一些部分将熔融并穿透相邻层4032、4033和4035,而层4032和4034的其他部分将维持它们的结构完整性。
除上述以外,每个层4031、4033和4035都可由两种或更多种材料构成。在某些情况下,每种包括粘合层4031、4033、4035的材料的熔融温度都高于附属物4030的最大处理温度。在其他情况下,一些包括粘合层4031、4033、4035的材料的熔融温度高于最大处理温度,而其他材料的熔融温度等于或低于最大处理温度。在此类实施方案中,一旦附属物4030的温度冷却到低于包括附属物4030的材料中的每一种的熔融温度,层4031、4033、4035的一些部分就将熔融并与相邻粘合层4032、4034的熔融部分混合,从而改善层4031、4032、4033、4034和4035之间的粘合。
附属物4030在暴露于热量时未被按压。附属物4030的熔融材料响应于作用于熔融材料的诸如重力和/或毛细作用力的自然力而流动;然而,可以设想其中附属物4030在暴露于热量时被按压的实施方案。此类压力可以改善熔融材料在附属物4030内的流动,并改善层4031、4032、4033、4034和4035之间的粘合。可以从附属物4030除去压力,而熔融部分仍然是可流动的。另选地,可以在熔融部分重新固化后,除去压力。
附属物4030包括五个层:然而,采用了本文所公开原理的附属物可以包括任何合适数量的层。例如,附属物可以包括三个层,这三个层包括第一外部层4031、第二外部层4035和定位在第一外部层4031与第二外部层4035的中间的粘合层。
在各种另选的实施方案中,附属物可能不利用粘合层。例如,附属物可以利用第一外部层4031和第二外部层4035,其中层4031、4035中的一者或两者由熔融以流动并将层4031、4035直接粘合在一起的材料构成。类似地,附属物可以利用外部层4031、4035和定位在外部层4031、4035的中间的中间层4033,其中层4031、4033、4035中的一个或多个层由熔融以流动并将层4031、4035直接粘合到中间层4033的材料构成。
如上所述,附属物4030的层4031、4033和4035由交织纤维构成。在某些情况下,层4031、4033和4035可以具有相同或至少基本上相同的编织密度。在其他情况下,层4031、4033和4035中的至少一个层可以具有与其他层不同的编织密度。再次参见图77,附属物4030”包括第一外部层4031”、第一粘合层4032”、分隔层4033”、第二粘合层4034”和第二外部层4035”。第二外部层4035”的编织密度大于第一外部层4031”的编织密度。类似地,第一外部层4031”的编织密度大于分隔层4033”的编织密度。
如上所述,附属物4030的粘合层4032和4034,当熔融时,可以穿透相邻层4031、4033和4035。粘合层4032和4034穿透层4031、4033和4035可以改变层4031、4033和4035的刚度。更具体地,粘合层4032、4034穿透层4031、4033和4035,可以增加层4031、4033和4035的刚度,这取决于粘合层4032、4034穿透层4031、4033、4035的程度。在各种情况下,粘合层4032、4034可以强化、固定和/或支撑相邻层4031、4033、4035的纤维。
除上述以外,可以选择层4031、4033和/或4035的编织密度,以控制层4032、4034在其中的穿透。现在参见图91和图92,附属物4730包括第一外部层4731、中间层4733、定位在第一外部层4731与中间层4733的中间的第一粘合层4732、第二外部层4735以及定位在第二外部层4735与中间层4733的中间的第二粘合层4734。中间层4733的某些部分具有低的或松散的编织密度,而中间层4733的其他部分具有高的或紧密的编织密度。当附属物4730被加热到至少等于第一粘合层4732的熔融温度的温度时,与中间层4733的具有紧密编织密度的部分相比,第一粘合层4732更深地穿透中间层4733的具有松散编织密度的部分。除此之外或者作为替代,第一外部层4731和/或第二外部层4735的编织密度可能能够控制粘合层4732和4734分别进入外部层4731和4735的穿透。
除上述以外,再次参见图75,可以选择开孔4036的密度、尺寸和/或深度以控制层4032和4034穿透分隔层4033的深度。由于以上所述,可以控制附属物4030的刚度。例如,附属物4030可以包括限定于其中的纵向路径,该纵向路径具有比附属物4030的其他部分更低的刚度。在这类情况下,横切附属物4030的刀可以沿具有低刚度的路径横切附属物4030。在至少一种情况下,附属物4030的近侧端部和远侧端部可以具有比附属物4030的其他部分更低的刚度。在这类情况下,附属物4030可以在击发行程的开始和结束时对其切割和缝合提供较小的阻力。
在各种另选的实施方案中,附属物可以包括粘合层,该粘合层并不穿透,或至少基本上穿透附属物的相邻层。在此类实施方案中,粘合层可以连接相邻层而基本上不影响相邻层的刚度。现在转向图90,附属物4630包括粘合层4632,该粘合层将第一外部层4631和中间层4633固持在一起,而不会穿透第一外部层4631和/或中间层4633。类似地,附属物4630包括粘合层4634,该粘合层将第二外部层4635和中间层4633固持在一起,而不会穿透第二外部层4635和/或中间层4633。
如上所述,附属物可以包括定位在第一外部层与第二外部层的中间的粘合层。现在转向图80和图81,附属物4230包括第一外部层4231、第二外部层4235和定位在第一外部层4231与第二外部层4235的中间的中间层4233。在这个实施方案中,外部层4231和4235由具有比包括中间层4233的材料的熔融温度更低的熔融温度的一种或多种材料构成。因此,外部层4231和4235的熔融温度限定附属物4230的阈值熔融温度。附属物4230暴露于至少部分地熔融外部层4231和4235但不熔融中间层4233的处理温度。
除此之外或者作为替代,可植入附属物的一个或多个层可以包括浮雕接合部或拉伸接合部。此外,可植入附属物的一个或多个层包括限定于其中的缓冲狭槽或拉伸狭槽。现在转向图78,可植入附属物4130包括第一外部层4131、第二外部层4135以及定位在第一外部层4131和第二外部层4135的中间的粘合层4133。现在转向图79和图82,第一外部层4131包括侧向地延伸穿过层4131的浮雕接合部4137。如图83所示,侧向浮雕接合部4137使得层4131和附属物4130的纵向刚度减小,并且促进层4131和附属物4130的纵向伸展。浮雕接合部4137具有相同的长度;然而,可以设想到其中一个或多个浮雕接合部4137具有的长度与其他浮雕接合部4137的长度不同的另选的实施方案。
再次参见图79,第二外部层4135包括纵向地延伸穿过层4135的浮雕接合部4136。纵向接合部4136在附属物4130的近侧端部与远侧端部之间延伸。纵向浮雕接合部4136使得层4131和附属物4130的侧向刚度减小,并且促进层4131和附属物4130的侧向伸展。浮雕接合部4136具有相同的长度;然而,可以设想到其中一个或多个浮雕接合部4136具有的长度与其他浮雕接合部4136的长度不同的另选的实施方案。
参见图79和图84,粘合层4133包括限定于其中的狭缝4138的阵列。狭缝4138被布置成沿纵向轴线延伸的纵向排。每个狭缝4138都包括细长构型,其中每个狭缝4138的最长维度与纵向排的轴线对准。如图85所示,狭缝4138促进层4133和附属物4130的纵向和/或侧向伸展。狭缝4138具有相同的构型;然而,可以设想到其中一个或多个狭缝4138具有的构型与其他狭缝4138的构型不同的另选的实施方案。在各种情况下,附属物的任何合适的层都可以包括狭缝4138。
现在转向图86,附属物的层4233包括限定于其中的开孔4238,这些开孔被构造成能够促进层4233的纵向和/或侧向拉伸。每个开孔4238都包括菱形构型。限定于一排中的开孔4238相对于限定于相邻排中的开孔4238侧向地和纵向地偏移。现在转向图87,附属物的层4333包括限定于其中的开孔4338,这些开孔被构造成能够促进层4333的纵向和/或侧向拉伸。每个开孔4338都包括圆形构型。限定于一排中的开孔4338与限定于相邻排中的开孔4338对准。现在转向图88,附属物的层4433包括限定于其中的开孔4438,这些开孔被构造成能够促进层4433的纵向和/或侧向拉伸。每个开孔4438都包括侧向地和纵向地延伸的Z字形狭缝。一排中的开孔4438相对于相邻排中的开孔4438侧向地和纵向地偏移。
可以在层中利用任何合适的过程形成本文所述的开孔。现在转向图89A,附属物4530的层4533包括限定于其中的多个开孔4538’。利用激光器4539’在层4533中烧出开孔4538’。现在转向图89B,利用可旋转模具4539”来在层4533中冲出开孔4538”。现在转向图89C,利用冲压模具4539”’来在层4533中冲出开孔4538”’。
参见图93,可压缩附属物组件6000包括外部纤维管状构件6002、内部纤维管状构件6010、第一中间纤维管状构件6004、第二中间纤维管状构件6006和第三中间纤维管状构件6008。在某些情况下,可压缩附属物组件6000可以仅包括内部纤维管状构件和外部纤维管状构件。另选地,可压缩附属物组件6000可以包括内部纤维管状构件和外部纤维管状构件以及仅一个中间纤维管状构件。另选地,可压缩附属物组件6000可以包括内部纤维管状构件和外部纤维管状构件以及仅两个中间纤维管状构件。另选地,可压缩附属物组件6000可以包括内部纤维管状构件和外部纤维管状构件以及多于三个中间纤维管状构件。
在某些情况下,可以利用非中空的芯部纤维构造物来切换内部纤维管状构件6010。在某些情况下,可压缩附属物组件6000可以由多个中空纤维构件构成,这些中空纤维构件不是管状的或圆柱形的。在某些情况下,可压缩附属物组件6000的多个中空纤维构件可以包括正方形或矩形的横截面积。本公开可设想到其他形状。
与本公开的其他可压缩附属物组件类似,可压缩附属物组件6000可以与外科缝合和切断器械的钳口构件例如外科缝合和切断器械8010的砧座8014和/或钉仓10000组装在一起。在某些情况下,第一可压缩附属物组件6000可以与砧座8014组装在一起并且第二可压缩附属物组件6000可以与钉仓10000组装在一起,使得当外科缝合和切断器械8010处于闭合构型时,组织被捕获在第一和第二可压缩附属物组件6000之间。在任一种情况下,可将多个钉部署到可压缩附属物组件6000中以紧固由外科缝合和切断器械8010捕获的组织。
可压缩附属物组件6000的纤维管状构件沿纵向轴线L-L同心地对准,并且围绕彼此,或至少部分地围绕彼此设置,如图93所示。第二中间纤维管状构件6006设置在第一中间纤维管状构件6004与第三纤维管状构件6008之间。为简明起见,除了外部纤维管状构件6002和内部纤维管状构件6010之外,以下对可压缩附属物组件6000的讨论还集中在第二中间纤维管状构件6006上。然而,读者将会知道,以下讨论同样适用于第一中间纤维管状构件6004和第三中间纤维管状构件6008。
参见图93,内部纤维管状构件6010的尺寸设定成装配,或至少部分地装配在中间纤维管状构件6006内,以限定两者间的圆柱形空间或间隙6012。同样,中间纤维管状构件6006的尺寸设定成配合在或至少部分地配合在外部纤维管状构件6002内,以限定两者间的圆柱形空间或间隙6014。如图93所示,内部纤维管状构件6010延伸,或至少部分地延伸穿过中间纤维管状构件6006,该中间纤维管状构件延伸,或至少部分地延伸穿过外部纤维管状构件6002。
参见图93,可压缩附属物组件6000的纤维管状构件为织造的。在某些情况下,可压缩附属物组件6000的纤维管状构件中的一个或多个纤维管状构件可为非织造构造。在至少一种情况下,内部纤维管状构件6010可由非中空的非织造纤维构造物构成。在任何情况下,可压缩附属物组件6000的相邻纤维管状构件的纤维相互缠结、相互关联和/或能够彼此相互作用。
可压缩附属物组件6000的纤维管状构件和/或纤维构造中的一者或多者包括响应于可压缩附属物组件6000的热处理而收紧或收缩的至少一个纤维。
所述至少一个纤维由在加热到预定温度时会经历尺寸减小的至少一种生物相容性材料构成。在至少一种情况下,所述至少一种生物相容性材料是弹性体。在某些情况下,所述至少一种生物相容性材料具有低于环境温度的玻璃化转变温度。
在某些情况下,热处理包括将可压缩附属物组件6000加热到预定温度。例如,可将可压缩附属物组件6000插入在烘箱中,可将该烘箱加热到预定温度。本公开设想到用于将热处理输送到可压缩附属物组件6000的其他技术。
除上述以外,可压缩附属物组件6000的纤维管状构件和/或纤维构造物中的一者或多者包括响应于可压缩附属物组件6000的热处理而经历从较为有序的相到不太有序的相的转变的至少一个纤维。在至少一种情况下,可压缩附属物组件6000包括响应于热处理而经历熵增加的至少一个纤维。
参见图94,所述至少一个纤维的收缩或收紧通过使可压缩附属物组件6000的单独纤维管状构件彼此靠得更近,从而减少单独纤维管状构件之间的空白空间,由此增强可压缩附属物组件6000。所述至少一个纤维的收缩可通过使纤维管状构件的纤维聚成一团或聚集成更紧凑的半有条理或无条理的管状结构,而使可压缩附属物组件6000致密化。因此,如图94所示,单独纤维管状构件可丧失其均匀管状框架并且替代地采用具有凸起和低凹的不规则形状,从而改善可压缩附属物组件6000的结构完整性。
参见图94,可压缩附属物组件6000的纤维管状构件和/或纤维构造物中的一个或多个可包含:
可生物吸收的材料,诸如以商品名VICRYL出售的聚乙醇酸(PGA)、聚乳酸(PLA或PLLA)、聚二氧六环酮(PDS)、聚羟基链烷酸酯(PHA)、以商品名MONOCRYL出售的聚卡普隆25(PGCL)、和/或聚己内酯(PCL)。可压缩附属物组件6000的纤维管状构件和/或纤维构造物中的一者或多者可包含一种或多种复合材料,所述一种或多种复合材料包括两种或更多种聚合物,这些聚合物选自例如PGA、PLA、PDS、PHA、PGCL和/或PCL。
再次参见图93,可压缩附属物组件6000的纤维管状构件和/或纤维构造物中的一个或多个包括由第一生物相容性材料(诸如VICRYL)构成的多个第一纤维,以及由不同于第一生物相容性材料的第二生物相容性材料(诸如PDS)构成的多个第二纤维。可压缩附属物组件6000包含的第一生物相容性材料多于第二生物相容性材料。在至少一种情况下,多个第一纤维的第一生物相容性材料与多个第二纤维的第二生物相容性材料的比例可为选自例如约3:1至约10:1范围的任何值。在至少一种情况下,第一生物相容性材料与第二生物相容性材料的比例可为选自例如约4:1至约9:1范围的任何值。在至少一种情况下,第一生物相容性材料与第二生物相容性材料的比例可为选自例如约5:1至约8:1范围的任何值。在至少一种情况下,第一生物相容性材料与第二生物相容性材料的比例为7:1。在至少一种情况下,第一生物相容性材料与第二生物相容性材料的比例为例如约5:1。本公开设想到第一生物相容性材料与第二生物相容性材料的其他比例。
在至少一种情况下,可压缩附属物组件6000的所有纤维管状构件和/或纤维构造物可具有相同或至少基本上相同的第一生物相容性材料与第二生物相容性材料的比例。另选地,可压缩附属物组件6000的纤维管状构件和/或纤维构造物可具有不同的第一生物相容性材料与第二生物相容性材料的比例。
将可压缩附属物组件6000加热到预定温度,在该预定温度下,多个第二纤维响应于热处理而经历与熵增加相对应的尺寸减小。在某些情况下,多个第一纤维和多个第二纤维发生缠结,因此多个第二纤维的收缩引起一些或所有多个第一纤维拉紧在一起,从而使可压缩附属物组件6000致密化。在某些情况下,多个第二纤维处于可压缩附属物组件6000的外部纤维管状构件中,而多个第一纤维处于可压缩附属物组件6000的内部纤维管状构件中。在此类情况下,多个第二纤维在收缩时可使外部纤维管状构件收紧内部纤维管状构件。
现在参见图95至图97,可压缩附属物组件6100在许多方面类似于可压缩附属物组件6000。例如,可压缩附属物组件6100包括彼此同心地对准且设置在彼此周围或至少部分地设置在彼此周围的多个纤维管状构件6102-6110。另外,可压缩附属物组件6100可与外科缝合和切断器械的钳口构件(诸如外科缝合和切断器械8010的砧座8014和/或钉仓10000)装配在一起。如下文更详细地讨论,通过热压工艺将可压缩附属物组件6100修改成所需的形状,以便与例如外科缝合和切断器械8010一起使用。
如图95所示,可将可压缩附属物组件6100插入到模具6020中,可将该模具加热到预定温度。向可压缩附属物组件6100施加预定外部压力,以便将可压缩附属物组件6100的形状修改为所需的形状,如图96所示。将可压缩附属物组件6100在预定温度和压力条件下保持预定时间段,之后使可压缩附属物组件6100冷却或将该可压缩附属物组件强制冷却到低于预定温度,同时保持外部压力。最后,移除外部压力,如图96所示。热压工艺的附加细节在提交于2014年2月24日的名称为“IMPLANTABLE LAYERS AND METHODS FOR ALTERINGIMPLANTABLE LAYERS FOR USE WITH SURGICAL FASTENING INSTRUMENTS”的美国专利申请序列号14/187,383中有所描述,该专利申请现为美国专利申请公布No.2015/0238185,其全部内容以引用方式并入本文。
再次参见图95至图97,可压缩附属物组件6100的纤维管状构件6102-6110中的一个或多个具有多个纤维,所述多个纤维包含具有玻璃化转变温度“Tg”的生物相容性材料。上述工艺的预定温度被设定为大于或等于生物相容性材料的玻璃化转变温度“Tg”但低于熔融温度。如图96所示,采用修改构件6122向可压缩附属物组件6100施加预定外部压力。预定外部压力被设定为足以将可压缩附属物组件6100修改为所需形状的压力。例如,预定外部压力的值部分地取决于模具6120的尺寸、可压缩附属物组件6100的初始尺寸和/或形状、和/或可压缩附属物组件6100的所需尺寸和/或形状。
在至少一种情况下,例如,将预定压力在预定温度下保持大约10分钟,和/或在低于预定温度的温度下保持大约10分钟。在某些情况下,可将预定压力例如在预定温度下保持约30秒至约8小时的时间段,和/或例如在低于预定温度的温度下保持约30秒至约8小时的时间段。本公开设想到用于保持预定温度和/或压力的其他时间段。
在某些情况下,仅外部纤维管状构件6102包含玻璃化转变温度“Tg”低于预定温度的生物相容性材料。但是,通过热压工艺对外部纤维管状构件6102的修改可足以使得外部纤维管状构件6102将设置在外部纤维管状构件6102内的其余纤维管状构件6104-6110保持处于所需形状。
在某些情况下,可压缩附属物组件6100的所需形状可包括正方形或矩形横截面区域。本公开设想到其他形状。在至少一种情况下,可压缩附属物组件6100包括矩形棱柱形状的横截面区域,该矩形棱柱具有斜平或压平的边缘和端部,以便与砧座(诸如砧座8014)和/或钉仓(诸如钉仓10000)附接和/或对准。
现在参见图98至图100,可压缩附属物组件6200在许多方面类似于可压缩附属物组件6000和6100。例如,可压缩附属物组件6200包括彼此同心地对准且设置在彼此周围或至少部分地设置在彼此周围的多个纤维管状构件。另外,可压缩附属物组件6200收缩或收紧成紧凑的半有条理或无条理的结构,使得单独纤维管状构件丧失其均匀管状框架并且替代地采用如图100所示具有凸起6214和低凹6216的不规则形状,从而改善可压缩附属物组件6200的结构完整性。另外,与可压缩附属物组件6100一样,可压缩附属物组件6200已在热压工艺期间从初始大体管状形状转变为所需形状,如图99所示。组件6200适用于与外科缝合和切断器械的钳口构件(诸如外科缝合和切断器械8010的砧座8014和/或钉仓10000)装配在一起。
参见图98,通过将可压缩附属物组件6200的附接部分6204插入到钉仓6202的细长狭槽6206中,而将可压缩附属物组件6200与钉仓6202装配在一起。附接部分6204略大于细长狭槽6206。因此,附接部分6204在插入到细长狭槽6206中时发生变形,并且变形的附接部分6204与细长狭槽6206的壁之间形成的摩擦保持可压缩附属物组件6200抵靠和/或邻近钉仓6202的仓平台6208。如图99所示,附接部分6204包括侧向延伸的顶端部分6210,从而改善可压缩附属物组件6200与钉仓6202的附接。在某些情况下,可采用附加或另选的附接技术将可压缩附属物组件6200可释放地附接到钉仓6202。在至少一种情况下,生物相容性胶可替换附接部分6204或可与附接部分6204一起使用。在后一种情况下,例如,可在附接部分6204插入到细长狭槽6206中之前向该附接部分施加生物相容性胶。
除上述以外,可压缩附属物组件6200包括第一可压缩部分6232和第二可压缩部分6234。细长狭槽或通道6230限定在第一可压缩部分6232和第二可压缩部分6234之间。当可压缩附属物组件与钉仓6202装配在一起时,细长狭槽6230沿着钉仓6202的细长狭槽6206的长度延伸或至少部分地沿着该长度延伸。附接部分6204从细长狭槽6230的底部处限定的基部6236突出,如图99所示。当推进击发组件9090(图3)以将钉部署到可压缩附属物组件6200及由外科缝合和切断器械8010捕集的组织中时,切割刃9116(图3)被驱动穿过细长狭槽6230。另外,切割刃9116可切割穿过附接部分6204。
在某些情况下,从基部6236撕下附接部分6204以从钉仓6202释放可压缩附属物组件6200。另选地,当从钉仓6202释放可压缩附属物组件6200时,从钉仓6202的细长狭槽6206中拉出附接部分6204。在某些情况下,在从钉仓6202释放可压缩附属物组件6200之后,基部6236保持完整或至少部分完整。在此类情况下,在完成释放之后,基部6236继续连接第一可压缩部分6232和第二可压缩部分6234。另选地,可切断或撕下基部6236,从而使第一可压缩部分6232和第二可压缩部分6234彼此分开。
附接部分6204沿着细长狭槽6230的长度连续地延伸。在某些情况下,附接部分6204被分成多个附接构件,它们彼此间隔开并且在纵向上沿着细长狭槽6230的长度布置。在至少一种情况下,所述多个附接构件彼此等距。另选地,与细长狭槽6230的第二部分相比,在细长狭槽6230的第一部分中所述多个附接构件可布置得彼此更近。在某些情况下,附接构件可集中在例如细长狭槽6230的近侧部分、远侧部分和/或中心部分处。
在至少一种情况下,所述多个附接构件中的一个或多个附接构件可包括具有矩形或至少基本上矩形的形状的顶表面。本公开设想到其他形状,诸如圆形形状或穹顶形形状。与附接部分6204一样,附接构件中的一个或多个附接构件可包括侧向延伸的端部。
参见图101,可压缩附属物组件6000的纤维管状构件和/或纤维构造物中的一个或多个包括由第一生物相容性材料(诸如VICRYL)构成的多个第一纤维6050,以及由不同于第一生物相容性材料的第二生物相容性材料(诸如PDS)构成的多个第二纤维6052。如图101所示,所述多个第二纤维6052可被熔融和再凝固以粘结和增强所述多个第一纤维6050。
在某些情况下,可将可压缩附属物组件6000加热到预定温度,该预定温度等于或大于第二生物相容性材料的熔融温度,但小于第一生物相容性材料的熔融温度。在此类情况下,所述多个第二纤维6052被熔融。熔融的材料沿着所述多个第一纤维6050流动,流动到所述多个第一纤维上,和/或在所述多个第一纤维之间流动。在冷却时,熔融的纤维6052粘结到纤维6050并且与相邻纤维互连,从而增强可压缩附属物组件6000的结构,如图101所示。
参见图102,可压缩附属物组件6200包括缠结形成三维结构的生物相容性纤维6302。另外,可压缩附属物组件6200包括粘结介质6310,该粘结介质限定增强可压缩附属物组件6200的三维结构的连结点或粘结节点6304。粘结节点6304包括由粘结介质6310围绕或至少部分地围绕的纤维6302的相邻部分,该粘结介质附连纤维6302的此类相邻部分。
再次参见图102,第一纤维6302’在第二纤维6302”之上延伸,而粘结介质6310在纤维6302’和6302”的相邻部分之间延伸。粘结介质6310附接到纤维6302’和6302”的相邻部分,从而限定粘结节点6304’。本公开设想到纤维6302和粘结节点6304的其他布置。在至少一种情况下,例如,粘结介质6310可将一个纤维的端部与另一个纤维的中间部分接合而限定粘结节点。
粘结节点6304限定可压缩附属物组件6200内的承载区,这些承载区的特征在于与缺少粘结节点6304的周围区相比增加的密度和/或更大的刚度。承载区可用作附接区域以便将可压缩附属物组件6200固定到外科缝合和切断器械的钳口构件,诸如外科缝合和切断器械8010的砧座8014和/或钉仓10000。
在某些情况下,第一可压缩附属物组件6200可与砧座8014一起装配并且第二可压缩附属物组件6200可与钉仓10000一起装配,使得当外科缝合和切断器械8010处于闭合构型时,组织被捕集在第一可压缩附属物组件和第二可压缩附属物组件6300之间。另外,可将多个钉部署到可压缩附属物组件6200中以紧固由外科缝合和切断器械8010捕集的组织,如本公开别处更详细所述。
再次参见图10A,可压缩附属物组件6200可由多个纤维6302和多个粘结纤维制成,所述多个粘结纤维被再成形或改变而形成粘结介质6310。纤维6302和粘结纤维缠结成三维结构,该三维结构最终形成可压缩附属物组件6200。纤维6302由具有第一熔点的第一生物相容性材料制成或至少部分地由该第一生物相容性材料制成,而粘结纤维由具有第二熔点的第二生物相容性材料制成或至少部分地由该第二生物相容性材料制成,第二熔点小于第一生物相容性材料的第一熔点。此外,纤维6302缺少或不包括粘结纤维的第二生物相容性材料;然而,在某些实施方案中,纤维6302中可存在少量第二生物相容性材料。
在某些情况下,纤维6302可由熔点大于粘结纤维的一种或多种生物相容性材料的一个或多个熔点的多种生物相容性材料制成。类似地,粘结纤维可由熔点小于纤维6302的一种或多种生物相容性材料的一个或多个熔点的多种生物相容性材料制成。
除上述以外,缠结纤维6302和粘结纤维的三维结构可经受一次或多次热压处理。向缠结纤维6302和粘结纤维的三维结构施加预定压力和/或温度,从而形成可压缩附属物组件6200。在某些情况下,可移除压力并且三维结构仅经受预定温度。在其他情况下,压力可被替换为可拉伸三维结构的张力。在某些情况下,可采用压力和张力的各种组合将三维结构模制成所需形状。
参见图103,采用模具6120和修改构件6122来实施热压处理。将三维结构(最终变成可压缩附属物组件6200)插入到模具6120中。然后操作修改构件6122以向三维结构施加预定压力,从而使三维结构成为所需形状。所施加的压力使纤维6302和粘结纤维的相邻部分更为接近,以准备好粘结纤维向粘结介质6310的转变。
在保持预定压力的同时,对模具进行加热以使三维结构达到预定温度。预定温度是能够熔融粘结纤维但不能熔融纤维6302的温度或温度范围。换句话讲,预定温度是大于或等于第二生物相容性材料的熔点但小于第一生物相容性材料的熔点的任何温度或温度范围。熔融的粘结纤维沿着纤维6302流动,流动到纤维上,和/或在纤维之间流动。
当将系统强制冷却或使其冷却到低于预定温度的温度时,粘结介质6310再凝固,使得在纤维6302的相邻部分之间形成粘结节点6304。此外,如图104所示,粘结介质6310可沿着纤维6302的长度涂覆或至少部分地涂覆纤维的至少部分。可在冷却期间保持预定压力。也可在完成冷却之后将预定压力保持预定时间段。当移除压力时,新形成的粘结节点6304保持或至少部分地保持可压缩附属物组件6200的新形状。
在某些情况下,预定压力使三维结构的高度下降。在至少一种情况下,高度减小选自例如约1%至约200%的值范围。本公开设想到由预定压力的施加所引起的高度减小的其他值。本公开还设想到类似的长度和/或宽度减小。在施加张力的情况下,三维结构的一个或多个维度可经历值的增加。在任何情况下,如图103所示,所得的可压缩附属物组件6200具有适用于与外科缝合和切断器械的钳口构件(诸如外科缝合和切断器械8010的砧座8014和/或钉仓10000)装配在一起的形状。
在至少一种情况下,例如,将预定压力在加热之前保持大约10分钟,在预定温度下保持大约10分钟,和/或在低于预定温度的温度下保持大约10分钟。在某些情况下,可将预定压力例如在加热之前保持约30秒至约8小时的时间段,例如在预定温度下保持约30秒至约8小时的时间段,和/或例如在低于预定温度的温度下保持约30秒至约8小时的时间段。本公开设想到用于保持预定温度和/或压力的其他时间段。
如图102所示,可压缩附属物组件6200的纤维6302是无条理的且随机缠结的。因此,可压缩附属物组件6200的粘结节点6304也是无条理的,并且随机定位在可压缩附属物组件6200内。另选地,可能期望制备粘结节点被组织成计划框架的可压缩附属物组件。为此,三维结构的纤维被系统地组织成计划图案。在至少一种情况下,纤维被针织或织造成基体或网络,该基体或网络具有被设计成产生粘结节点的交点。
参见图104,可压缩附属物组件6400在许多方面类似于可压缩附属物组件6200。例如,可压缩附属物组件6400可以可释放地附接到外科缝合和切断器械的钳口构件,诸如外科缝合和切断器械8010的砧座8014和/或钉仓10000。另外,可压缩附属物组件6400包括彼此间隔开且大致沿第一方向布置的第一纤维6402,以及也彼此间隔开且大致沿与第一方向相交的第二方向布置的第二纤维6403。第一纤维6402和第二纤维6403相互缠结,从而形成具有多个交点的纤维的基体或网络。
可压缩附属物组件6400还包括粘结纤维,这些粘结纤维被熔融和再凝固而形成粘结介质6410,该粘结介质在第一纤维6402与第二纤维6403之间的交点处限定粘结节点6404。粘结节点6404可包括一个或多个纤维6402的部分和一个或多个纤维6403的部分。粘结纤维可策略性地布置成与纤维6402和/或6403相邻,从而允许粘结介质6410沿着纤维6402和/或6403流动,流动到纤维上,和/或在纤维之间流动。
再次参见图104,由第一纤维6402和第二纤维6403限定的框架嵌入或至少部分地嵌入在粘结介质6410中。在某些情况下,粘结节点6404形成于纤维6402与纤维6403之间的交点处。在某些情况下,粘结节点6404形成于三个纤维(包括一个纤维6402与两个纤维6403、或两个纤维6402与一个纤维6403)之间的交点处。其他粘结节点6404可包括纤维6402和6403的各种其他组合。
可压缩附属物组件6400的相邻纤维之间的距离可至少部分地决定此空间被粘结介质6410填充或桥接的程度。相邻纤维之间的距离越大,熔融的粘结纤维就越不可能桥接此类相邻纤维之间的间隙。熔融的粘结纤维的流动性和/或粘结纤维的厚度也可决定粘结介质6410是否能够填充或桥接其间的空间。保持未被填充的空间限定了可呈不同形状和尺寸的间隙6408,如图104所示。间隙6408的数量和尺寸尤其决定可压缩附属物组件6400的孔隙度。因此,可通过增加相邻纤维之间的距离来增加可压缩附属物组件6400的孔隙度。另选地,可通过减小相邻纤维之间的距离来减小可压缩附属物组件6400的孔隙度。在至少一种情况下,间隙6408由多个纤维限定,所述多个纤维包括纤维6402中的两个和纤维6403中的两个,它们相交形成间隙6408周围的四个粘结节点6404。
现在参见图105,可压缩附属物组件6500在许多方面类似于可压缩附属物组件6300和6400。例如,可压缩附属物组件6400可以可释放地附接到外科缝合和切断器械的钳口构件,诸如外科缝合和切断器械8010的砧座8014和/或钉仓10000。
另外,可压缩附属物组件6500包括顶部部分6512以及与顶部部分6512间隔开的底部部分6514。多个纤维6502和多个纤维6503在顶部部分6512与底部部分6514之间延伸。纤维6502间隔开并且彼此沿由轴线A-A限定的第一方向平行或至少基本上平行延伸。同样,纤维6503间隔开并且彼此沿由轴线B-B限定的第二方向平行或至少基本上平行延伸。顶部部分6512和底部部分6514彼此平行或至少基本上平行。轴线A-A以角度α1与顶部部分6512和底部部分6514相交,而轴线B-B以角度α2与顶部部分6512和底部部分6514相交。角度α2大于角度α1。
在某些情况下,例如,角度α2大于90°并且角度α1小于90°。在至少一种情况下,角度α1选自例如约45°至约85°的范围。在至少一种情况下,角度α2选自例如约135°至约175°的范围。在至少一种情况下,角度α1为例如约60°。在至少一种情况下,角度α2为例如约150°。本公开设想到角度α1和α2的其他值。
除上述以外,每个纤维6502包括在两个端部6502a和6502c之间延伸的中间部分6502b。同样,每个纤维6503包括在两个端部6503a和6503c之间延伸的中间部分6503b。中间部分6502b和6503b相交,从而形成其间的角度α3,如图105所示。角度α3小于90°。在某些情况下,角度α3选自例如约15°至约85°的范围。在至少一种情况下,角度α3为例如约35°。本公开设想到角度α3的其他值。
再次参见图105,纤维6502的端部6502a与相邻纤维6503的端部6503a相交,并且限定其间的角度α4。端部6502a和6503a在它们的交点处锚定到顶部部分6512。同样,端部6502c与端部6503c相交,从而限定其间的角度α5。端部6502c和6503c在它们的交点处锚定到底部部分6514。在某些情况下,角度α4和α5相同或至少基本上相同。在至少一种情况下,角度α4和α5选自例如约15至约85的范围。
除上述以外,可压缩附属物组件6500包括粘结介质6510,该粘结介质限定增强可压缩附属物组件6500的三维结构的连结点或粘结节点。粘结节点6504a包括使由粘结介质6510围绕或至少部分地围绕的端部6502a和6503a相交,该粘结介质附连相交的端部6502a和6503a。同样,粘结节点6504c包括使由粘结介质6510围绕或至少部分地围绕的端部6502c和6503c相交,该粘结介质附连相交的端部6502c和6503c。可压缩附属物组件6500包括粘结节点6504b,这些粘结节点包括使由粘结介质6510围绕或至少部分地围绕的中间部分6502b和6503b相交,该粘结介质附连相交的中间部分6502b和6503b。与可压缩附属物组件6200一样,可压缩附属物组件6500还包括粘结纤维,这些粘结纤维被熔融和再凝固,从而以与形成粘结介质6310的相同或至少基本上相同的方式形成粘结介质6510。
再次参见图105,粘结节点6504a在顶排6516中对准,粘结节点6504c在底排6518中对准,并且粘结节点6504b在顶排6516与底排6518之间的中间排6520中对准。粘结节点6504b的中间排6520不与粘结节点6504a的顶排6516和粘结节点6504c的底排6518对准。换句话讲,粘结节点6504b与两个连续粘结节点6504a之间的第一间隙和两个连续粘结节点6504c之间的第二间隙对准。该布置改善了可压缩附属物组件6500的稳定性。中间排6520与排6516和6518等距或至少基本上等距。在某些情况下,中间排6520离顶排6516比离底排6518更近。另选地,在其他情况下,中间排6520离底排6518可比离顶排6516更近。读者应当理解,本文所用的术语“顶部”和“底部”仅出于方便的目的。可压缩附属物组件6500可上下颠倒,使得底排6516位于顶部上且顶排6518位于底部上。
再次参见图105,粘结节点6504b处的粘结介质6510防止或至少抵抗横切纤维6502和6503相对于彼此的平移。该布置可至少部分地增大可压缩附属物组件6500的裂断强度和/或改善其回弹率。虽然可压缩附属物组件6500被示出为仅具有三排粘结节点,但应当理解,该排数是作为示例提供的。在某些情况下,可压缩附属物组件6500可仅包括两排粘结节点。另选地,可压缩附属物组件6500可包括四排或更多排粘结节点。
在某些情况下,可压缩附属物组件6500的第一构建块包括五个粘结节点,其中中心粘结节点6504b悬置在两个第一粘结节点6504a与两个第一粘结节点6504c之间。中心粘结节点6504b通过纤维6502或纤维6503的一部分拴系到四个粘结节点6502a和6502c每一者。拴系部分6522未被粘结介质6510覆盖。可压缩附属物组件6500的第二构建块可定位在第一构建块的第一侧上。第二构建块也可由五个粘结节点构成,并且可与第一构建块共享粘结节点。此外,可压缩附属物组件6500的第三构建块可定位在例如与第一侧相对的第一构建块的第二侧上,使得第一构建块定位在第二构建块和第三构建块之间。第三构建块也可由五个粘结节点构成,并且可与第一构建块共享粘结节点。
再次参见图105,如上所述,纤维6502和6503的拴系部分6522未被粘结介质6510覆盖。另选地,拴系部分6522中的一个或多个拴系部分可被粘结介质6510覆盖或至少部分地覆盖,以增加可压缩附属物组件6500的构建块的刚度,从而增加可压缩附属物组件6500的总体刚度。可以设想,通过改变拴系部分6522的刚度来选择性地产生更可压缩或更不可压缩的附属物6522,从而控制可压缩附属物组件6500的刚度。
现在参见图106,可压缩附属物组件6600在许多方面类似于可压缩附属物组件6300、6400和6500。例如,可压缩附属物组件6600可以可释放地附接到外科缝合和切断器械的钳口构件,诸如外科缝合和切断器械8010的砧座8014和/或钉仓10000。另外,可压缩附属物组件6600包括顶部部分6512和底部部分6514。
除上述以外,可压缩附属物组件6600包括多个构建块6630。如图106所示,构建块6630包括第一纤维6602、第二纤维6603和粘结纤维。粘结纤维被熔融和再凝固,从而以与形成粘结介质6310、6410和6510相同或至少基本上相同的方式形成粘结介质6610。构建块6630中的纤维6602和6603彼此在顶部部分6512与底部部分6514之间平行或至少基本上平行延伸。内部横向距离“A”将纤维6602和6603分开。粘结纤维沿着纤维6602和6603之间的空间中限定的横向轴线Z-Z在顶部部分6512与底部部分6514之间延伸或至少部分地延伸。
再次参见图106,粘结介质6610限定增强可压缩附属物组件6600的三维结构的连结点或粘结节点6604。粘结节点6604包括由粘结介质6110围绕或至少部分地围绕的纤维6302和6603的相邻部分,该粘结介质附连纤维6302和6603的此类相邻部分。纤维6602和6603完全嵌入在粘结介质6610中。另选地,在某些情况下,纤维6602和6603仅部分地嵌入在粘结介质6610中或被该粘结介质覆盖。
可压缩附属物组件6600的构建块6630内的内部横向距离“A”可至少部分地决定此空间被粘结介质6610填充或桥接的程度。熔融的粘结纤维的流动性和/或粘结纤维的厚度也可决定粘结介质6610是否能够填充或桥接内部横向距离“A”。保持未被填充的空间限定了可呈不同形状和尺寸的间隙6608,如图106所示。间隙6608的数量和尺寸尤其决定可压缩附属物组件6600的孔隙度。因此,可通过增加内部横向距离“A”来增加构建块6630内的可压缩附属物组件6600的孔隙度。另选地,可通过减小内部横向距离“A”来减小构建块6630内的可压缩附属物组件6600的孔隙度。
再次参见图106,相邻构建块6630以其间的足够空间间隔开,从而防止熔融的粘结纤维在相邻构建块6630之间的流动。中间距离“B”限定在相邻构建块6630之间。中间距离“B”大于内部横向距离“A”。中间距离“B”还大于由构建块6630限定的外部横向距离“C”。在至少一种情况下,外部横向距离“C”与中间距离“B”的比例为选自例如约0.1至例如约0.9的范围的任何比例。在至少一种情况下,外部横向距离“C”与中间距离“B”的比例为选自例如约0.2至例如约0.8的范围的任何比例。在至少一种情况下,外部横向距离“C”与中间距离“B”的比例为选自例如约0.3至例如约0.7的范围的任何比例。在至少一种情况下,外部横向距离“C”与中间距离“B”的比例为例如约0.4。本公开设想到外部横向距离“C”与中间距离“B”的比例的其他值。
现在参见图107,可压缩附属物组件6700在许多方面类似于可压缩附属物组件6300、6400、6500和6600。例如,可压缩附属物组件6700可以可释放地附接到外科缝合和切断器械的钳口构件,诸如外科缝合和切断器械8010的砧座8014和/或钉仓10000。另外,可压缩附属物组件6700包括顶部部分6512、底部部分6514和多个构建块6730,所述多个构建块包括第一纤维6602和第二纤维6603。另外,构建块6730包括成角度的粘结纤维,这些成角度的粘结纤维被熔融和再凝固,从而以与形成粘结介质6310、6410、6510和6610相同或至少基本上相同的方式形成粘结介质6710。
现在参见图107,构建块6730内的粘结介质6710沿着以角度α1横切顶部部分6512和底部部分6514的轴线z-z延伸或至少部分地延伸。角度α1小于90°。在某些情况下,角度α1在约15°至约85°的范围内。在至少一种情况下,角度α1为约45°。本公开设想到角度α1的其他值。
构建块6730内的粘结介质6710包括第一粘结部分6710a,该第一粘结部分在顶部部分6512与纤维6602第一侧上的第一纤维6602之间延伸。第二粘结部分6710b在第一纤维6602的第二侧与和第一纤维6602平行或至少基本上平行延伸的纤维6603的第一侧之间延伸。另外,第三粘结部分6710c在第二纤维6603的第二侧和底部部分6214之间延伸。第一粘结部分6710a将第一纤维6602附连到顶部部分6512,并且第三粘结部分6710c将第二纤维6603附连到底部部分6514。另外,第二粘结部分6710b将第一纤维6602附连到第二纤维6603。这种布置通过以下方式稳定构建块6730:分别为纤维6602和6603提供粘结部分6710a和6710c形式的附加锚定件,并且经由第二粘结部分6710b将第一纤维6602附连到第二纤维6603,如图107所示。
除上述以外,纤维部分6710a、5710b和6710c以交叉角α2和α3沿着轴线z-z延伸。在至少一种情况下,交叉角α2和α3相同。在至少一种情况下,交叉角α2和α3不同。在至少一种情况下,交叉角α2和α3中的一者或两者在例如约105°至约175°的范围内。在至少一种情况下,交叉角α2和α3中的一者或两者在例如约125°至约165°的范围内。本公开设想到交叉角α2和α3的其他值。
除上述以外,可利用任何合适的工艺制造和/或修改可植入层或附属物,从而为该层提供所需特性。在各种情况下,可利用例如熔丝制造来制造可植入附属物。在至少一种此类情况下,例如将聚合物细丝送入挤出机中,加热,然后迫使其穿过喷嘴进入模具中和/或直接置于钉仓上。通过夹送系统将细丝送入挤出机中,该夹送系统可控制细丝送入挤出机中的方向和/或速率。通过加热器块使细丝至少部分地熔融。加热器块可定位在相对于喷嘴的上游和/或喷嘴内。模具和/或钉仓定位在可动床上,该可动床可相对于喷嘴运动。可使用这种熔丝制造工艺控制可植入附属物内的孔隙度。在至少一种情况下,将受热的聚合物细丝分配成利用例如三角形、弧形、六边形和/或任何合适的多边形形状的互连图案。此外,可将受热的聚合物材料分配在一个层或彼此堆叠的多个层中。聚合物材料所分配成的一个或多个图案和层数可控制可植入附属物的孔隙度。更为多孔的可植入附属物可促进组织在可植入附属物中的向内生长。另外,这种工艺可在不使用例如冻干工艺和/或二氧杂环己烷的情况下形成可植入附属物。
除上述以外,可利用激光工艺形成可植入附属物中的开口。在至少一种情况下,可利用激光在由例如PGA和/或PCL构成的挤出膜中切出孔。该膜可具有例如大约0.003”的厚度,并且这些孔可具有例如大约0.001”的直径。这些孔可为例如微空隙,并且可包括任何合适形状的周边,诸如圆形、六边形和/或三角形。可形成任何合适数量的孔。例如,数百个孔可用于可植入附属物。这些孔可均匀地分布,或以任何合适的方式分布。在各种情况下,这些孔可分配成一定图案,该图案包括例如侧向地、纵向地和/或对角地对准的排。在各种情况下,挤出膜的若干层可彼此堆叠和粘结,从而形成可植入附属物。例如,可使用四个或五个膜层。另外,例如,可在不利用粘合剂的情况下通过将膜层加热到高于至少一个膜层的玻璃化转变温度来粘结膜层。这些膜层可具有相同孔图案或不同图案。在某些情况下,这些层中的至少一个层具有开孔,而这些层中的至少一个层没有开孔。在各种情况下,可利用激光工艺从可植入附属物或可植入附属物的一层移除本体形状。在至少一种此类情况下,可例如沿着纵向切割线和/或朝向可植入附属物的外周边在一层中形成线,从而产生阶梯状效果,尤其是当这个层与未移除此类本体形状的另一层堆叠和粘结时。在各种情况下,可利用激光工艺例如沿着可植入附属物的外边缘和/或沿着上述内线产生羽化效果。例如,可利用激光工艺沿着周边和/或在可植入附属物中限定的开口内减小可植入附属物的厚度,例如从大约0.006”减小到大约0.002”至0.003”。此外,可利用激光工艺对可植入附属物进行任何其他合适的局部改变。例如,可调谐钉所捕集的附属物的部分中的孔的密度,从而在这些区域中软化附属物。在至少一种情况下,这些孔可限于某些区。例如,可在附属物中形成与钉腿对准的更强的无孔区,而更弱的孔区与钉冠或基部对准。上述示例的反向也是可能的。虽然可利用激光工艺修改由例如膜构成的可植入附属物,但可利用激光工艺修改由例如泡沫和/或熔喷非织造材料构成的可植入附属物。除了上述激光工艺之外或代替上述激光工艺,可利用例如水切割、冲压、冲孔和/或穿孔。另外,除了上述激光工艺以外或代替上述激光工艺,可植入附属物可经历造窝工艺,该造窝工艺可局部拉伸附属物。凹窝可具有比附属物的非凹窝区域更薄的厚度。凹窝能够以与孔相同或相似的方式使用,以实现相同或相似的结果。在各种情况下,凹窝和/或孔可存在于附属物的任何合适层中。在至少一种情况下,凹窝和/或孔隐埋或存在于例如附属物的内层中。在某些情况下,在由高分子量聚合物构成的附属物内选择性使用低分子量聚合物,可用于在附属物内形成更软的区域。最后,可利用上述工艺形成具有一定孔隙度的柔顺、高弹性且可拉伸的可植入附属物,该孔隙度足以促进组织向内生长。
实施例
实施例1-一种向仓体施加可植入层的方法,包括以下步骤:获得包括钉腔的钉仓体,加热聚合物材料,以及使所加热的聚合物材料朝向钉仓体加速,使得可植入层形成在钉腔上方。
实施例2-根据实施例1所述的方法,还包括在加速步骤之前将钉插入钉腔中的步骤。
实施例3-根据实施例1或2所述的方法,还包括以下步骤:冷却所加热的聚合物材料以及在冷却步骤之后修剪该聚合物材料。
实施例4-根据实施例3所述的方法,其中仓体包括周边,并且其中在修剪步骤期间根据周边来修剪可植入层。
实施例5-根据实施例1、2、3或4所述的方法,其中加热步骤包括将聚合物材料加热到高于其玻璃化转变温度。
实施例6-根据实施例1、2、3、4或5所述的方法,其中加热步骤包括将聚合物材料加热到高于其熔融温度。
实施例7-根据实施例1、2、3、4、5或6所述的方法,还包括以下步骤:加热第二聚合物材料,以及使所加热的第二聚合物材料朝向钉仓体加速,使得第二可植入层形成在钉腔上方。
实施例8-根据实施例1、2、3、4、5、6或7所述的方法,其中所加热的聚合物材料包括加热的第一聚合物材料,并且其中加速步骤包括使加热的第二聚合物材料与加热的第一聚合物材料一起朝向钉仓体加速。
实施例9-根据实施例1、2、3、4、5、6、7或8所述的方法,其中在不将聚合物材料与溶剂混合的情况下执行该方法。
实施例10-根据实施例1、2、3、4、5、6、7、8或9所述的方法,其中
实施例11-根据实施例1、2、3、4、5、6、7、8、9或10所述的方法,其中加速步骤包括利用电荷使聚合物材料加速。
实施例12-根据实施例1、2、3、4、5、6、7、8、9、10或11所述的方法,其中加速步骤包括利用电压差使聚合物材料加速。
实施例13-根据实施例1、2、3、4、5、6、7、8、9、10、11或12所述的方法,其中加速步骤包括利用旋转构件使聚合物材料加速。
实施例14-根据实施例1、2、3、4、5、6、7、8、9、10、11、12或13所述的方法,其中加速步骤包括利用重力将聚合物材料倾倒到钉仓体上。
实施例15-根据实施例1、2、3、4、5、6、7、8、9、10、11、12、13或14所述的方法,其中加速步骤包括以下步骤:向聚合物材料施加平移加速度以及向聚合物材料施加旋转加速度。
实施例16-根据实施例1、2、3、4、5、6、7、8、9、10、11、12、13、14或15所述的方法,其中加速步骤包括在钉仓体上形成随机的多孔聚合物结构。
实施例17-根据实施例1、2、3、4、5、6、7、8、9、10、11、12、13、14、15或16所述的方法,其中加热步骤包括液化聚合物材料。
实施例18-根据实施例1、2、3、4、5、6、7、8、9、10、11、12、13、14、15或16所述的方法,其中加热步骤不包括液化聚合物材料。
实施例19-一种向仓体施加可植入层的方法,包括以下步骤:获得包括钉腔的钉仓体,加热聚合物材料,以及将所加热的聚合物材料直接施加到钉仓体上,使得可植入层形成在钉腔上方。
实施例20-一种向仓体施加可植入层的方法,包括以下步骤:获得包括钉腔的钉仓体,加热材料,以及使所加热的材料朝向钉仓体加速,使得可植入层形成在钉腔上方。
实施例21-一种钉仓组件,包括仓体,该仓体包括平台、多个钉、以及定位在平台上方的可植入层。可植入层包含由具有第一热转变温度的第一材料构成的多个第一纤维,以及由具有第二热转变温度的第二材料构成的多个第二纤维,其中第二热转变温度低于第一热转变温度,其中第二材料与第一材料相互混合,并且其中在使该层暴露于超过第二热转变温度的工艺温度的工艺期间,第二纤维在该层内收缩。
实施例22-根据实施例21所述的钉仓组件,其中多个第二纤维被布置成结构栅格框架,并且其中结构栅格框架在该工艺期间收缩。
实施例23-根据实施例21或22所述的钉仓组件,其中第二材料包括聚二氧六环酮。
实施例24-根据实施例21、22或23所述的钉仓组件,其中第一材料包括聚乙醇酸。
实施例25-根据实施例21、22、23或24所述的钉仓组件,其中可植入层是可植入层组件的一部分,该可植入层组件还包括层压膜。
实施例26-根据实施例21、22、23、24或25所述的钉仓组件,其中工艺温度小于第一热转变温度。
实施例27-一种钉仓组件,包括仓体,该仓体包括平台、多个钉、以及定位在平台上方的可植入层。可植入层包括由具有第一热转变温度的第一材料构成的网状物,以及由具有第二热转变温度的第二材料构成的纤维,其中第一热转变温度低于第二热转变温度,其中这些纤维与网状物交织在一起,并且其中在使该层暴露于超过第一热转变温度的工艺温度的工艺期间,网状物收紧。
实施例28-根据实施例27所述的钉仓组件,其中第一材料包括聚二氧六环酮。
实施例29-根据实施例27或28所述的钉仓组件,其中第二材料包括聚乙醇酸。
实施例30-根据实施例27、28或29所述的钉仓组件,其中可植入层是可植入层组件的一部分,该可植入层组件还包括层合膜。
实施例31-根据实施例27、28、29或30所述的钉仓组件,其中工艺温度小于第二热转变温度。
实施例32-一种钉仓组件,包括仓体,该仓体包括平台、多个钉、以及定位在平台上方的可植入层。可植入层包括由具有第一玻璃化转变温度的第一材料构成的多个第一纤维,以及由具有第二玻璃化转变温度的第二材料构成的多个第二纤维,其中第二玻璃化转变温度低于第一玻璃化转变温度,其中第二材料与第一材料交织在一起,并且其中此前已超过第二玻璃化转变温度,从而使第二纤维收缩。
实施例33-根据实施例32所述的钉仓组件,其中第一材料包括聚二氧六环酮。
实施例34-根据实施例32或33所述的钉仓组件,其中第二材料包括聚乙醇酸。
实施例35-根据实施例32、33或34所述的钉仓组件,其中可植入层是可植入层组件的一部分,该可植入层组件还包括层合膜。
实施例36-一种制造可植入层的方法,该方法包括以下步骤:获得由具有第一热转变温度的第一材料构成的第一纤维,获得由具有第二热转变温度的第二材料构成的第二纤维,其中第二热转变温度低于第一热转变温度,使第一纤维与第二纤维相互混合,以及在相互混合步骤之后,将第二纤维加热到超过第二热转变温度的加工温度,使得第二纤维收缩。
实施例37-根据实施例36所述的方法,其中相互混合步骤包括交织第一纤维和第二纤维。
实施例38-根据实施例36或37所述的方法,其中加工温度不超过第一热转变温度。
实施例39-根据实施例36、37或38所述的方法,其中相互混合步骤包括将第一纤维交织到第二纤维的网状物中。
实施例40-一种与外科器械一起使用的可压缩附属物,其中可压缩附属物包括中空纤维构造物以及容纳在中空纤维构造物内的芯纤维构造物,其中中空纤维构造物包含至少一种生物相容性材料,所述至少一种生物相容性材料响应于将中空纤维构造物加热到预定温度而经历从较为有序的相向不太有序的相的至少一次转变。
实施例41-根据实施例40所述的可压缩附属物,其中所述至少一次转变将中空纤维构造物收紧在芯纤维构造物周围。
实施例42-根据实施例40或41所述的可压缩附属物,其中所述至少一次转变包括熵增加。
实施例43-根据实施例40、41或42所述的可压缩附属物,其中所述至少一种生物相容性材料为弹性体。
实施例44-根据实施例40、41、42或43所述的可压缩附属物,其中芯纤维构造物包含所述至少一种生物相容性材料。
实施例45-根据实施例40、41、42、43或44所述的可压缩附属物,其中中空纤维构造物响应于所述至少一次转变而从第一尺寸转变为小于第一尺寸的第二尺寸。
实施例46-根据实施例40、41、42、43、44或45所述的可压缩附属物,还包括细长狭槽,其中细长狭槽沿着中空纤维构造物的长度延伸,并且其中细长狭槽沿着芯纤维构造物的长度延伸。
实施例47-一种与外科器械一起使用的可压缩附属物,该可压缩附属物包括中空纤维构造物,该中空纤维构造物包括在内部限定空间的第一纤维管状构件以及用至少一次热处理进行处理的第二纤维管状构件,其中该中空纤维构造物至少部分地延伸穿过该空间。
实施例48-根据实施例47所述的可压缩附属物,其中第一纤维管状构件响应于所述至少一次热处理而收缩在第二纤维管状构件周围。
实施例49-根据实施例47或48所述的可压缩附属物,其中第一纤维管状构件包含至少一种生物相容性材料,该至少一种生物相容性材料响应于所述至少一次热处理而经历从较为有序的相向不太有序的相的至少一次转变。
实施例50-根据实施例47、48或49所述的可压缩附属物,其中中空纤维构造物包含响应于所述至少一次热处理而经历临时相变的至少一种生物相容性材料。
实施例51-根据实施例49或50所述的可压缩附属物,其中所述至少一种生物相容性材料为弹性体。
实施例52-根据实施例49、50或51所述的可压缩附属物,其中所述至少一种生物相容性材料为可吸收的。
实施例53-根据实施例47、48、49、50、51或52所述的可压缩附属物,其中中空纤维构造物包含响应于所述至少一次热处理而经历临时相变的第一生物相容性材料,以及在所述至少一次热处理期间保持处于固相的第二生物相容性材料。
实施例54-根据实施例47所述的可压缩附属物,其中中空纤维构造物响应于所述至少一次热处理而从第一尺寸转变为小于第一尺寸的第二尺寸。
实施例55-一种用于制备与外科器械一起使用的可压缩附属物的方法,该方法包括提供在内部限定空间的第一纤维管状构件,提供尺寸被设定为能配合到该空间中的第二纤维管状构件,将第二纤维管状构件插入到该空间中,以及通过至少一次热处理执行第一纤维管状构件和第二纤维管状构件中的至少一者的至少一次改变。
实施例56-根据实施例55所述的方法,其中执行步骤包括使第一纤维管状构件收缩在第二纤维管状构件周围。
实施例57-根据实施例55或56所述的方法,其中第一纤维管状构件和第二纤维管状构件中的至少一者包含至少一种生物相容性材料,并且其中执行步骤包括执行所述至少一种生物相容性材料的临时相变。
实施例58-根据实施例55、56或57所述的方法,其中第一纤维管状构件和第二纤维管状构件中的至少一者包含至少一种生物相容性材料,并且其中执行步骤包括所述至少一种生物相容性材料从较为有序的相向不太有序的相的至少一次转变。
实施例59-根据实施例55、56、57或58所述的方法,其中执行步骤包括在第二纤维管状构件周围的第一纤维管状构件中的所述至少一者的尺寸的至少一次改变。
实施例60-一种钉仓组件,包括仓体,该仓体包括平台、多个钉、以及定位在平台上方的可植入层,其中可植入层包括多个交织纤维,并且其中每个纤维包括具有扭结构型的股线。
实施例61-根据实施例60所述的钉仓组件,其中通过使纤维暴露于热量来产生纤维的扭结构型。
实施例62-根据实施例60或61所述的钉仓组件,其中将扭结纤维交织成第一织造区和第二织造区,其中第一织造区具有第一密度且第二织造区具有第二密度,并且其中第一密度不同于第二密度。
实施例63-根据实施例62所述的钉仓组件,其中可植入层包括周边,其中第二密度大于第一密度,并且其中第二织造区沿着周边限定。
实施例64-根据实施例62所述的钉仓组件,其中仓体包括被构造成能够接收切割部分的纵向狭槽,其中第一密度小于第二密度,并且其中第一织造区与纵向狭槽对准。
实施例65-根据实施例62或63所述的钉仓组件,还包括锚定件,该锚定件在可植入层之上延伸以将该层可释放地保持到仓体,其中第二密度大于第一密度,并且其中锚定件与第二织造区对准。
实施例66-根据实施例65所述的钉仓组件,其中仓体还包括纵向狭槽,其中该纵向狭槽被构造成能够接收切割构件,并且其中该切割构件被构造成能够在该切割构件在纵向狭槽内运动时横切锚定件。
实施例67-根据实施例65或66所述的钉仓组件,还包括近侧端部,其中锚定件和第二织造区与近侧端部相邻。
实施例68-根据实施例67所述的钉仓组件,还包括远侧端部,该远侧端部与近侧端部相对;远侧锚定件,该远侧锚定件在可植入层之上延伸以将该层可释放地保持到仓体;以及第三织造区,该第三织造区限定在该层中并且具有大于第一密度的第三密度,其中远侧锚定件与第三织造区对准。
实施例69-根据实施例62、63、64、65、66、67或68所述的钉仓组件,其中仓体包括第一纵向排钉腔和第二纵向排钉腔,其中第一织造区与第一排钉腔对准,并且第二织造区与第二排钉腔对准。
实施例70-根据实施例60、61、62、63、64、65、66、67、68或69所述的钉仓组件,其中将扭结纤维交织成第一织造区和第二织造区,其中第一织造区具有第一弹性模量并且第二织造区具有第二弹性模量,并且其中第一弹性模量不同于第二弹性模量。
实施例71-根据实施例70所述的钉仓组件,其中可植入层包括周边,其中第二密度大于第一密度,并且其中第二织造区沿着周边限定。
实施例72-根据实施例70或71所述的钉仓组件,其中仓体包括被构造成能够接收切割部分的纵向狭槽,其中第一弹性模量小于第二弹性模量,并且其中第一织造区与纵向狭槽对准。
实施例73-根据实施例70或71所述的钉仓组件,还包括锚定件,该锚定件在可植入层之上延伸以将该层可释放地保持到仓体,其中第二弹性模量大于第一弹性模量,并且其中锚定件与第二织造区对准。
实施例74-根据实施例73所述的钉仓组件,其中仓体还包括纵向狭槽,其中该纵向狭槽被构造成能够接收切割构件,并且其中该切割构件被构造成能够在该切割构件在纵向狭槽内运动时横切锚定件。
实施例75-根据实施例73或74所述的钉仓组件,还包括近侧端部,其中锚定件和第二织造区与该近侧端部相邻。
实施例76-根据实施例75所述的钉仓组件,还包括远侧端部,该远侧端部与近侧端部相对;远侧锚定件,该远侧锚定件在可植入层之上延伸以将该层可释放地保持到仓体;以及第三织造区,该第三织造区限定在该层中并且具有大于第一弹性模量的第三弹性模量,其中远侧锚定件与第三织造区对准。
实施例77-根据实施例70、71、72、73、74、75或76所述的钉仓组件,其中仓体包括第一纵向排钉腔和第二纵向排钉腔,其中第一织造区与第一排钉腔对准并且第二织造区与第二排钉腔对准。
实施例78-一种制造可植入层的方法,该方法包括以下步骤:获得纤维,织造纤维,在织造步骤之后退织纤维,在退织步骤之后扭结纤维,以及在扭结步骤之后将纤维重织成可植入层。
实施例79-根据实施例78所述的方法,其中重织步骤包括将纤维针织成蓬松织物。
实施例80-一种与包括钉仓平台的外科器械一起使用的可压缩附属物,其中可压缩附属物包含第一生物相容性材料、熔融温度低于第一生物相容性材料的第二生物相容性材料以及主体,该主体包括可抵靠钉仓平台的长度定位的面。该面包括彼此间隔开的多个附接区域,其中所述多个附接区域包含第二生物相容性材料,并且其中该面可在所述多个附接区域处选择性地附接到钉仓平台。该面还包括在所述多个附接区域之间延伸的多个非附接区域,其中第二生物相容性材料选择性地设置在非附接区域之外。
实施例81-根据实施例80所述的可压缩附属物,其中所述多个附接区域限定附接模式。
实施例82-根据实施例80或81所述的可压缩附属物,其中该主体包括织造纤维构造物。
实施例83-根据实施例80、81或82所述的可压缩附属物,其中第一生物相容性材料和第二生物相容性材料中的至少一者为可吸收的。
实施例84-根据实施例80、81、82或83所述的可压缩附属物,其中第二生物相容性材料为聚对二氧杂环己酮(PDS)。
实施例85-一种与外科缝合器械一起使用的钉仓组件,其中该钉仓组件包括钉仓,该钉仓包括多个钉以及具有外表面的仓平台。钉仓还包括纤维构造物,该纤维构造物包括:一,主体,该主体包括由具有第一熔融温度的第一生物相容性材料构成的多个第一纤维;以及二,面,该面抵靠仓平台的外表面定位。该面包括彼此间隔开的多个附接区域,其中所述多个附接区域中的每个附接区域包括由具有低于第一熔融温度的第二熔融温度的第二生物相容性材料构成的多个第二纤维;以及在所述多个附接区域之间延伸的多个非附接区域,其中非附接区域不包括多个第二纤维,并且其中通过将该面暂时加热到大于或等于第二熔融温度但小于第一熔融温度的温度,而将该面在所述多个附接区域处选择性地附接到外表面。
实施例86-根据实施例85所述的钉仓组件,其中所述多个附接区域限定附接模式。
实施例87-根据实施例85或86所述的钉仓组件,其中纤维构造物为织造纤维构造物。
实施例88-根据实施例85、86或87所述的钉仓组件,其中第一生物相容性材料和第二生物相容性材料中的至少一者是可吸收的。
实施例89-根据实施例85、86、87或88所述的钉仓组件,其中第二生物相容性材料为聚对二氧杂环己酮(PDS)。
实施例90-根据实施例85、86、87、88或89所述的钉仓组件,其中仓平台还包括被构造成能够将纤维构造物固定到外表面的至少一个附接构件。
实施例91-根据实施例90所述的钉仓组件,其中所述至少一个附接构件包括机械倒钩。
实施例92-根据实施例85、86、87、88、89、90或91所述的钉仓组件,其中外表面包括多个粗糙区。
实施例93-根据实施例92所述的钉仓组件,其中将粗糙区蚀刻到外表面中。
实施例94-一种与外科缝合器械一起使用的钉仓组件,其中钉仓组件包括钉仓,该钉仓包括多个钉和仓平台。仓平台包括外表面,该外表面包括彼此间隔开的多个附接区以及多个粘结岛状部,其中所述多个粘结岛状部中的每个粘结岛状部设置在附接区中的一个附接区内,并且其中所述多个粘结岛状部中的每个粘结岛状部由第一生物相容性材料构成。钉仓组件还包括抵靠仓平台定位的可压缩层,其中该可压缩层由不同于第一生物相容性材料的第二生物相容性材料构成,并且其中通过第一生物相容性材料的临时相变而将可压缩层固定到仓平台。
实施例95-根据实施例94所述的钉仓组件,其中第一生物相容性材料的临时相变不伴随第二生物相容性材料的相转变。
实施例96-根据实施例94或95所述的钉仓组件,其中仓平台还包括被构造成能够将可压缩层固定到仓平台的至少一个附接构件。
实施例97-根据实施例96所述的钉仓组件,其中所述至少一个附接构件包括机械倒钩。
实施例98-根据实施例94、95、96或97所述的钉仓组件,其中将附接区蚀刻到外表面中。
实施例99-一种外科器械,包括钳口构件,该钳口构件包括沿着纵向轴线延伸的细长狭槽、该细长狭槽的第一侧上的第一外表面、以及该细长狭槽的与第一侧相对的第二侧上的第二外表面。外科器械还包括可压缩附属物组件,该可压缩附属物组件包括附接层,该附接层包括细长狭槽的第一侧上的第一区段,其中第一区段附接到第一外表面;细长狭槽的第二侧上的第二区段,其中第二区段附接到第二外表面;以及在第一区段与第二区段之间延伸的中间区段,其中中间区段至少部分地桥接细长狭槽。可压缩附属物组件还包括细长狭槽的第一侧上的第一可压缩附属物、以及细长狭槽的第二侧上的第二可压缩附属物,其中第一可压缩附属物与第二可压缩附属物间隔开,其中第一区段附接到第一可压缩附属物,并且其中第二区段附接到第二可压缩附属物。
实施例100-根据实施例99所述的外科器械,其中中间区段包括沿着中间区段的长度延伸的杆,其中杆从第一区段逐步升高,并且杆从第二区段逐步升高。
实施例101-根据实施例100所述的外科器械,其中杆与细长狭槽纵向地对准。
实施例102-根据实施例100或101所述的外科器械,其中杆突出到限定在第一可压缩附属物与第二可压缩附属物之间的间隙中。
实施例103-根据实施例100、101或102所述的外科器械,其中杆突出到细长狭槽中。
实施例104-根据实施例99、100、101、102或103所述的外科器械,其中中间区段包括用于将可压缩附属物组件固定到钳口构件的至少一个锚定特征结构。
实施例105-根据实施例99、100、101、102、103或104所述的外科器械,其中中间区段包括彼此间隔开的多个突出部。
实施例106-根据实施例105所述的外科器械,其中突出部与细长狭槽纵向地对准。
实施例107-根据实施例105或106所述的外科器械,其中突出部突出到被限定在第一可压缩附属物和第二可压缩附属物之间的间隙中。
实施例108-根据实施例105、106或107所述的外科器械,其中突出部突出到细长狭槽中。
实施例109-根据实施例100、101、102、103、104、105、106、107或108所述的外科器械,其中附接层包括膜。
实施例110-根据实施例100、101、102、103、104、105、106、107、108或109所述的外科器械,其中附接层薄于第一可压缩附属物,并且其中附接层薄于第二可压缩附属物。
实施例111-根据实施例100、101、102、103、104、105、106、107、108、109或110所述的外科器械,其中第一区段将第一可压缩附属物与第一外表面完全分开,并且其中第二区段将第二可压缩附属物与第二外表面完全分开。
实施例112-根据实施例100、101、102、103、104、105、106、107、108、109、110或111所述的外科器械,其中第一可压缩附属物沿第一方向远离细长狭槽侧向地延伸超过第一区段,并且其中第一外表面沿第一方向侧向地延伸超过第一区段。
实施例113-根据实施例112所述的外科器械,其中第二可压缩附属物沿第二方向远离细长狭槽侧向地延伸超过第二区段,其中第二外表面沿第二方向侧向地延伸超过第二可压缩附属物,并且其中第二方向与第一方向相反。
实施例114-根据实施例100、101、102、103、104、105、106、107、108、109、110、111、112或113所述的外科器械,其中第一外表面包括多个第一凹坑,其中第二外表面包括多个第二凹坑,其中附接层定位在多个第一凹坑与多个第二凹坑之间。
实施例115-一种外科器械,包括钳口构件,该钳口构件包括沿着纵向轴线延伸的细长狭槽、该细长狭槽的第一侧上的第一外表面、以及该细长狭槽的与第一侧相对的第二侧上的第二外表面。外科器械还包括可压缩附属物组件,该可压缩附属物组件包括可压缩层,该可压缩层包括细长狭槽的第一侧上的第一可压缩部分、细长狭槽的第二侧上的第二可压缩部分、以及由多个间隙分开的多个第一桥接部分,其中多个第一桥接部分在第一可压缩部分与第二可压缩部分之间延伸,其中多个第一桥接部分沿着细长狭槽的长度布置,并且其中多个第一桥接部分中的每个第一桥接部分桥接细长狭槽。可压缩附属物组件还包括附接层,该附接层包括细长狭槽的第一侧上的第一附接部分,其中第一附接部分附接到第一外表面,并且其中第一附接部分附接到第一可压缩部分;以及细长狭槽的第二侧上的第二附接部分,其中第二附接部分附接到第二外表面,并且其中第二附接部分附接到第二可压缩部分。附接层还包括由所述多个间隙分开的多个第二桥接部分,其中多个第二桥接部分在第一附接部分与第二附接部分之间延伸,其中多个第二桥接部分沿着细长狭槽的长度布置,并且其中多个第二桥接部分中的每个第二桥接部分桥接细长狭槽。
实施例116-根据实施例115所述的外科器械,其中附接层包括膜。
实施例117-根据实施例115或116所述的外科器械,其中附接层薄于可压缩层。
实施例118-一种外科器械,包括砧座,该砧座包括沿着纵向轴线延伸的细长狭槽、限定连接到细长狭槽的内部间隙的内表面、细长狭槽的第一侧上的第一外表面、以及该细长狭槽的与第一侧相对的第二侧上的第二外表面。外科器械还包括可压缩附属物组件,该可压缩附属物组件包括可压缩层,该可压缩层包括细长狭槽的第一侧上的第一可压缩部分、细长狭槽的第二侧上的第二可压缩部分、以及在第一可压缩部分和第二可压缩部分之间延伸的中间可压缩部分,其中中间可压缩部分桥接该狭槽。可压缩附属物组件还包括至少一个附接构件,该至少一个附接构件包括抵靠内表面定位的第一附接部分、附接到中间可压缩部分的第二附接部分、以及将第一附接部分连接到第二附接部分的联接部分。
实施例119-根据实施例118所述的外科器械,其中联接部分延伸到细长狭槽中。
实施例120-根据实施例118或119所述的外科器械,其中第二附接部分嵌入在中间可压缩部分中。
实施例121-一种与外科缝合器械一起使用的钉仓组件,其中该钉仓组件被构造成能够接收击发致动,使得在接收到击发致动时,击发组件被构造成能够在击发进程期间穿过钉仓组件从近侧端部平移到远侧端部,并且其中钉仓组件包括仓体、可移除地储存在仓体中的多个钉、以及可植入附属物。可植入附属物包括主体部分和多个不同的附接部分,该多个不同的附接部分被构造成能够保持附属物抵靠在仓体上,其中击发组件被构造成能够在击发进程期间接合每个附接部分,并且其中在击发组件从近侧端部向远侧端部的推进期间,附接部分逐渐从仓体释放。
实施例122-根据实施例121所述的钉仓组件,其中每个钉被构造成能够将每个附接部分与仓体分开。
实施例123-根据实施例121或122所述的钉仓组件,其中击发组件被构造成能够将可植入附属物提升离开仓体以从仓体释放可植入附属物。
实施例124-根据实施例121、122或123所述的钉仓组件,还包括多个驱动器,其中仓体包括平台表面,其中击发组件被构造成能够将驱动器提升到平台表面之上。
实施例125-根据实施例121、122、123或124所述的钉仓组件,其中仓体包括多个钉腔,并且其中附接部分至少部分地延伸到钉腔中。
实施例126-根据实施例121、122、123、124或125所述的钉仓组件,其中可植入附属物包括一体件的材料。
实施例127-根据实施例121、122、123、124、125或126所述的钉仓组件,其中仓体包括狭槽,其中附接部分定位在狭槽附近,并且其中击发组件包括释放部分,该释放部分被构造成能够在击发组件从近侧端部推进到远侧端部时接合附接部分以从仓体释放可植入附属物。
实施例128-根据实施例121、122、123、124、125、126或127所述的钉仓组件,其中可植入附属物包括第一部分和第二部分,其中第一部分被构造成能够从第二部分拆下,并且其中第二部分被构造成能够通过尚未由击发组件部署的钉保持抵靠在仓体上。
实施例129-根据实施例121、122、123、124、125、126、127或128所述的钉仓组件,其中可植入附属物还包括不连续部分,并且其中第一部分能够在不连续部分处从第二部分拆下。
实施例130-根据实施例129所述的钉仓组件,其中不连续部分包括至少一个穿孔。
实施例131-根据实施例121、122、123、124、125、126、127、128、129或130所述的钉仓组件,其中每个钉包括一对钉腿,并且其中每个钉腿包括嵌入在可植入附属物中的倒钩。
实施例132-根据实施例131所述的钉仓组件,其中倒钩向外延伸。
实施例133-根据实施例121、122、123、124、125、126、127、128、129、130、131或132所述的钉仓组件,其中仓体包括多个钉腔,并且其中每个附接部分在钉腔之上延伸。
实施例134-根据实施例121、122、123、124、125、126、127、128、129、130、131、132或133所述的钉仓组件,其中钉接合附接部分并且在钉从仓体射出时从仓体拆下附接部分。
实施例135-一种钉仓组件,包括仓体,该仓体包括近侧端部、远侧端部、平台、限定在平台中的多个钉腔、以及限定在平台中的从近侧端部朝向远侧端部延伸的纵向狭槽。钉仓组件还包括可移除地储存在钉腔内的多个钉、被构造成能够在击发构件从近侧端部朝向远侧端部的击发进程期间从钉腔射出钉的击发构件、以及可植入附属物。可植入附属物包括主体部分和多个不同的附接部分,所述多个不同的附接部分被构造成能够可释放地保持可植入附属物抵靠在仓体上,其中击发构件被构造成能够在击发进程期间从仓体逐渐释放附接部分。
实施例136-根据实施例135所述的钉仓组件,其中击发构件在平台之上延伸并且直接接合附接部分。
实施例137-根据实施例135或136所述的钉仓组件,其中钉腔被布置成纵向排,其中纵向排包括与纵向狭槽相邻的内部纵向排,并且其中附接部分定位在纵向狭槽和内部纵向排的中间。
实施例138-根据实施例137所述的钉仓组件,其中击发构件沿着平台在纵向狭槽与内部纵向排之间滑动。
实施例139-一种用于装配与外科缝合器械一起使用的外科缝合组件的方法,该外科缝合组件包括钉仓、多个钉、以及至少部分地定位在钉仓上的纤维附属物,该方法包括将纤维辅助材料倾倒到与钉仓类似的模具上,使纤维辅助材料冷却,从模具移除纤维辅助材料,以及将纤维辅助材料放置到钉仓上,其中纤维辅助材料在放置到钉仓上时保持连续的纤维结构。
实施例140-一种钉仓组件,包括仓体,该仓体包括平台、可移除地储存在仓体中的钉、以及定位在平台上方的可植入附属物。可植入附属物包括由交织纤维构成的第一外层、由交织纤维构成的第二外层、以及定位在第一外层和第二外层的中间的粘结层,其中粘结层由具有阈值熔融温度的可熔材料构成,并且其中附属物此前已暴露于超过阈值熔融温度的温度,使得粘结层与第一外层和第二外层粘结在一起。
实施例141-根据实施例140所述的钉仓组件,其中第一外层的交织纤维由具有大于阈值熔融温度的第一熔融温度的第一材料构成,并且其中第一外层的交织纤维未被熔融。
实施例142-根据实施例141所述的钉仓组件,其中第二外层的交织纤维由不同于第一熔融温度且大于阈值熔融温度的第二材料构成,并且其中第二外层的交织纤维未被熔融。
实施例143-根据实施例140、141或142所述的钉仓组件,其中粘结层包括第一粘结层,并且其中附属物还包括由熔融温度大于阈值熔融温度的材料构成的分隔层以及由可熔材料构成的第二粘结层,其中第一粘结层定位在第一外层和分隔层的中间,并且其中第二粘结层定位在第二外层和分隔层的中间。
实施例144-根据实施例143所述的钉仓组件,其中分隔层包括限定于其中的多个开口,所述多个开口被构造成能够在附属物暴露于超过阈值熔融温度的温度时接收第一粘结层和第二粘结层的熔融部分。
实施例145-根据实施例143或144所述的钉仓组件,其中第一粘结层的熔融部分已穿透第一外层,并且其中第二粘结层的熔融部分已穿透第二外层。
实施例146-根据实施例143、144或145所述的钉仓组件,其中所述多个开口被布置成在分隔层的第一部分中的第一密度和被布置成在分隔层的第二部分中的第二密度,其中第一密度大于第二密度,并且其中第一部分与粘结层之间的粘结强于第二部分与粘结层之间的粘结。
实施例147-根据实施例143、144、145或146所述的钉仓组件,其中分隔层包括膨体编织物。
实施例148-根据实施例140、141、142、143、144、145、146或147所述的钉仓组件,其中粘结层包括PDS膜。
实施例149-根据实施例140、141、142、143、144、145、146、147或148所述的钉仓组件,其中粘结层包括限定于其中的开孔。
实施例150-根据实施例140、141、142、143、144、145、146、147、148或149所述的钉仓组件,其中粘结层已穿透第一外层和第二外层。
实施例151-根据实施例140、141、142、143、144、145、146、147、148、149或150所述的钉仓组件,其中第一外层和第二外层包括由可熔材料构成的可熔部分,并且其中在附属物暴露于超过阈值熔融温度的温度之后,第一外层和第二外层的可熔部分与粘结层合并。
实施例152-一种钉仓组件,包括仓体,该仓体包括平台、可移除地储存在仓体中的钉、以及定位在平台上方的可植入层组件。可植入层包括第一层、第二层、以及定位在第一层和第二层的中间的粘结层,其中粘结层由具有阈值熔融温度的可熔材料构成,并且其中可植入层组件此前已暴露于至少等于阈值熔融温度的温度,使得粘结层与第一层和第二层中的至少一者粘结在一起。
实施例153-根据实施例152所述的钉仓组件,其中粘结层机械地粘结到第一层和第二层。
实施例154-根据实施例152或153所述的钉仓组件,其中第一层的交织纤维由具有大于阈值熔融温度的第一熔融温度的第一材料构成,并且其中第一层的交织纤维未被熔融。
实施例155-根据实施例154所述的钉仓组件,其中第二层的交织纤维由不同于第一熔融温度且大于阈值熔融温度的第二材料构成,并且其中第二层的交织纤维未被熔融。
实施例156-根据实施例152、153、154或155所述的钉仓组件,其中粘结层包括第一粘结层,并且其中可植入层组件还包括由熔融温度大于阈值熔融温度的材料构成的分隔层以及由可熔材料构成的第二粘结层,其中第一粘结层定位在第一层和分隔层的中间,并且其中第二粘结层定位在第二层和分隔层的中间。
实施例157-根据实施例156所述的钉仓组件,其中分隔层包括限定于其中的多个开口,所述多个开口被构造成能够在附属物暴露于至少等于阈值熔融温度的温度时接收第一粘结层和第二粘结层的熔融部分。
实施例158-根据实施例157所述的钉仓组件,其中所述多个开口被布置成在分隔层的第一部分中的第一密度和被布置成在分隔层的第二部分中的第二密度,其中第一密度大于第二密度,并且其中第一部分与粘结层之间的粘结强于第二部分与粘结层之间的粘结。
实施例159-根据实施例156、157或158所述的钉仓组件,其中第一粘结层的熔融部分已穿透第一层,并且其中第二粘结层的熔融部分已穿透第二层。
实施例160-一种制造钉仓组件的方法,包括以下步骤:获得第一层、第二层和粘结层,将粘结层定位在第一层和第二层的中间,将粘结层加热到使粘结层至少部分地熔融的温度,获得仓体,将钉定位在仓体中,以及将第一层、第二层和粘结层附接到仓体。
实施例161-根据实施例160所述的方法,其中加热步骤不会使第一层和第二层熔融。
实施例162-一种与外科缝合器一起使用的钉仓组件,其中钉仓组件包括钉仓,该钉仓包括仓体、仓平台、以及可穿过仓平台从仓体部署的多个钉。钉仓组件还包括可抵靠仓平台定位的可压缩附属物,其中可压缩附属物包括多个未改变的纤维,所述多个未改变的纤维包括具有第一纤维部分的第一纤维以及具有在第一纤维部分之上延伸的第二纤维部分的第二纤维。可压缩附属物还包括被熔融和再凝固的多个改变的纤维以及节点,该节点包括第一纤维部分、第二纤维部分以及所述多个改变的纤维的至少一部分,其中所述多个改变的纤维的所述至少一部分附连第一纤维部分和第二纤维部分。
实施例163-根据实施例162所述的钉仓组件,其中第一纤维和第二纤维由具有第一熔点的第一生物相容性材料构成。
实施例164-根据实施例163所述的钉仓组件,其中所述多个改变的纤维包括具有低于第一熔点的第二熔点的第二生物相容性材料。
实施例165-根据实施例164所述的钉仓组件,其中第一纤维至少部分地覆盖有第二生物相容性材料。
实施例166-根据实施例162、163、164或165所述的钉仓组件,其中所述多个未改变的纤维还包括具有在第一纤维部分之上延伸的第三纤维部分的第三纤维。
实施例167-根据实施例162、163、164、165或166所述的钉仓组件,其中该节点将可压缩附属物可释放地附接到仓平台。
实施例168-根据实施例162、163、164、165、166或167所述的钉仓组件,还包括限定附接区的多个节点。
实施例169-根据实施例168所述的钉仓组件,还包括附接区之间的非附接区。
实施例170-根据实施例169所述的钉仓组件,其中附接区具有大于非附接区的密度。
实施例171-一种与外科缝合器一起使用的钉仓组件,其中钉仓组件包括钉仓,该钉仓包括仓体、仓平台、以及可穿过仓平台从仓体部署的多个钉。钉仓组件还包括可抵靠仓平台定位的可压缩附属物,其中可压缩附属物包括多个未改变的纤维,所述多个未改变的纤维包括具有第一纤维部分的第一纤维以及具有在第一纤维部分之上延伸的第二纤维部分的第二纤维。可压缩附属物还包括被熔融和再凝固以限定粘结介质的多个改变的纤维以及节点,该节点包括第一纤维部分、第二纤维部分、以及至少部分地围绕第一纤维部分和第二纤维部分的粘结介质的至少一部分。
实施例172-根据实施例171所述的钉仓组件,其中第一纤维和第二纤维由具有第一熔点的第一生物相容性材料构成。
实施例173-根据实施例172所述的钉仓组件,其中所述多个改变的纤维包括具有低于第一熔点的第二熔点的第二生物相容性材料。
实施例174-根据实施例173所述的钉仓组件,其中第一纤维至少部分地覆盖有第二生物相容性材料。
实施例175-根据实施例171、172、173或174所述的钉仓组件,其中所述多个未改变的纤维还包括具有在第一纤维部分之上延伸的第三纤维部分的第三纤维。
实施例176-根据实施例171、172、173、174或175所述的钉仓组件,其中该节点将可压缩附属物可释放地附接到仓平台。
实施例177-根据实施例171、172、173、174、175或176所述的钉仓组件,还包括限定附接区的多个节点。
实施例178-根据实施例177所述的钉仓组件,还包括附接区之间的非附接区。
实施例179-根据实施例178所述的钉仓组件,其中附接区具有大于非附接区的密度。
实施例180-一种与外科缝合器一起使用的钉仓组件,其中钉仓组件包括钉仓,该钉仓包括仓体、仓平台、以及可穿过仓平台从仓体部署的多个钉。钉仓组件还包括可抵靠仓平台定位的可压缩附属物,其中可压缩附属物包括多个纤维,所述多个纤维包括具有第一纤维部分的第一纤维以及具有与第一纤维部分间隔开的第二纤维部分的第二纤维。可压缩附属物还包括被熔融和再凝固的粘结纤维,其中粘结纤维包括在第一纤维部分与第二纤维部分之间延伸的粘结纤维部分,其中粘结纤维部分附接到第一纤维部分,并且其中粘结纤维部分附接到第二纤维部分。
实施例181-根据实施例180所述的钉仓组件,其中第一纤维和第二纤维由具有第一熔点的第一生物相容性材料构成,并且其中粘结纤维包含具有低于第一熔点的第二熔点的第二生物相容性材料。
所公开的各种实施方案包括附接到钉仓并且/或者定位在钉仓上的辅助件。应当理解,此类教导内容适用于辅助件附接到外科器械的砧座并且/或者定位在砧座上的实施方案。事实上,设想到其中第一辅助件附接到仓并且/或者定位在仓上并且第二辅助件附接到砧座并且/或者定位在砧座上的实施方案。
本公开的可压缩附属物可抵靠钉仓的仓平台(诸如钉仓12的仓平台16)定位。在至少一种情况下,在将钉仓加载到外科器械(诸如外科缝合和切断器械8010(图1))上之前,可压缩附属物可抵靠钉仓的仓平台定位。另选地,在钉仓已加载到外科缝合和切断器械中之后,可压缩附属物可抵靠钉仓的仓平台定位。可采用加载单元将可压缩附属物沉积到钉仓的仓平台上。加载单元可包括各种附接特征结构和/或布置特征结构,以便操纵可压缩附属物并且将可压缩附属物抵靠仓平台定位。一旦可压缩附属物正确地抵靠仓平台定位,加载单元就可释放可压缩附属物。
除上述以外,可压缩附属物可抵靠仓平台定位而不附接到钉仓。另选地,在钉仓加载到外科缝合和切断器械中之前,可压缩附属物可附接到钉仓。例如,可压缩附属物可部分地熔融到仓平台上,然后通过冷却而再凝固,从而使可压缩附属物粘结到仓平台。可采用各种附接特征结构将可压缩附属物附接到钉仓,诸如缝合线、条带、倒钩和/或其他机械附接机构。
下述专利的全部公开内容据此以引用方式并入本文:
公布于1995年4月4日的名称为“ELECTROSURGICAL HEMOSTATIC DEVICE”的美国专利5,403,312;
公布于2006年2月21日的名称为“SURGICAL STAPLING INSTRUMENT HAVINGSEPARATE DISTINCT CLOSING AND FIRING SYSTEMS”的美国专利7,000,818;
公布于2008年9月9日的名称为“MOTOR-DRIVEN SURGICAL CUTTING ANDFASTENING INSTRUMENT WITH TACTILE POSITION FEEDBACK”的美国专利7,422,139;
公布于2008年12月16日的名称为“ELECTRO-MECHANICAL SURGICAL INSTRUMENTWITH CLOSURE SYSTEM AND ANVIL ALIGNMENT COMPONENTS”的美国专利7,464,849;
公布于2010年3月2日的名称为“SURGICAL INSTRUMENT HAVING AN ARTICULATINGEND EFFECTOR”的美国专利7,670,334;
公布于2010年7月13日的名称为“SURGICAL STAPLING INSTRUMENTS”的美国专利7,753,245;
公布于2013年3月12日的名称为“SELECTIVELY ORIENTABLE IMPLANTABLEFASTENER CARTRIDGE”的美国专利8,393,514;
名称为“SURGICAL INSTRUMENT HAVING RECORDING CAPABILITIES”的美国专利申请序列号11/343,803;现为美国专利7,845,537;
提交于2008年2月14日的名称为“SURGICAL CUTTING AND FASTENING INSTRUMENTHAVING RF ELECTRODES”的美国专利申请序列号12/031,573;
提交于2008年2月15日的名称为“END EFFECTORS FOR A SURGICAL CUTTING ANDSTAPLING INSTRUMENT”的美国专利申请序列号12/031,873(现为美国专利No.7,980,443);
名称为“MOTOR-DRIVEN SURGICAL CUTTING INSTRUMENT”的美国专利申请序列号12/235,782,现为美国专利8,210,411;
名称为“POWERED SURGICAL CUTTING AND STAPLING APPARATUS WITH MANUALLYRETRACTABLE FIRING SYSTEM”的美国专利申请序列号12/249,117,现为美国专利8,608,045;
2009年12月24日提交的名称为“MOTOR-DRIVEN SURGICAL CUTTING INSTRUMENTWITH ELECTRIC ACTUATOR DIRECTIONAL CONTROL ASSEMBLY”的美国专利申请序列号12/647,100;现为美国专利8,220,688;
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,现为美国专利号8,733,613;
提交于2011年2月28日的名称为“SURGICAL STAPLING INSTRUMENT”的美国专利申请序列号13/036,647,现为美国专利号8,561,870;
名称为“SURGICAL STAPLING INSTRUMENTS WITH ROTATABLE STAPLE DEPLOYMENTARRANGEMENTS”的美国专利申请序列号No.13/118,241,现为美国专利9,072,535;
2012年6月15日提交的名称为“ARTICULATABLE SURGICAL INSTRUMENTCOMPRISING A FIRING DRIVE”的美国专利申请序列号13/524,049;现为美国专利9,101,358;
提交于2013年3月13日的名称为“STAPLE CARTRIDGE TISSUE THICKNESS SENSORSYSTEM”的美国专利申请序列号13/800,025,现为美国专利申请公布2014/0263551;
提交于2013年3月13日的名称为“STAPLE CARTRIDGE TISSUE THICKNESS SENSORSYSTEM”的美国专利申请序列号13/800,067,现为美国专利申请公布2014/0263552;
提交于2006年1月31日的名称为“SURGICAL CUTTING AND FASTENING INSTRUMENTWITH CLOSURE TRIGGER LOCKING MECHANISM”的美国专利申请公布2007/0175955;以及
提交于2010年4月22日的名称为“SURGICAL STAPLING INSTRUMENT WITH ANARTICULATABLE END EFFECTOR”的美国专利申请公布2010/0264194,现为美国专利8,308,040。
虽然本文已结合某些公开的实施方案描述了装置的各种实施方案,但也可实施对这些实施方案的许多修改和变型。另外,在公开了用于某些部件的材料的情况下,也可使用其它材料。此外,根据多种实施方案,单个部件可被替换为多个部件,并且多个部件也可被替换为单个部件,以执行给定的一种或多种功能。上述具体实施方式和下述权利要求旨在涵盖所有此类修改和变型。
本文所公开的装置可被设计成在单次使用后废弃,或者其可被设计成能够使用多次。然而无论是哪种情况,该器械都可在至少使用一次后经过修复再行使用。修复可包括拆卸装置、清洁或更换具体部件以及后续重新组装的其中任意几个步骤的组合。具体地,所述装置可拆卸,而且可以任意组合选择性地更换或移除所述装置的任意数目的特定零件或部件。在清洁和/或替换特定部件后,可对所述装置进行重新组装,以便随后在修复设施处使用或就在外科手术之前由外科小组人员使用。本领域的技术人员将会理解,修复装置可利用各种技术来进行拆卸、清洁/替换和重新组装。此类技术的使用以及所得的修复装置均在本申请的范围内。
仅以举例的方式,可在外科手术之前对本文所述的方面进行处理。首先,可以获得新的或用过的器械,并且根据需要进行清洁。然后,可对器械进行消毒。在一种灭菌技术中,将所述器械放置在密闭且密封的容器(诸如,塑料或TYVEK袋)中。然后可将容器和器械置于可穿透所述容器的辐射场,例如γ辐射、X射线或高能电子。辐射可以杀死器械上和容器中的细菌。消毒后的器械随后可被存放在无菌容器中。密封容器可将器械保持处于无菌状态,直至在医疗设施中将该容器打开。还可使用本领域已知的任何其它技术对装置进行消毒,所述技术包括但不限于β或γ辐射、环氧乙烷或蒸汽。
尽管本发明已被描述为具有示例性设计,但可在本公开的实质和范围内进一步修改本发明。因此,本专利申请旨在涵盖使用本发明的一般原理的本发明的任何变型、用途或改型。
以引用方式全文或部分地并入本文的任何专利、公布或其它公开材料均仅在所并入的材料不与本公开所提出的现有定义、陈述或其它公开材料相冲突的范围内并入本文。因此,并且在必要的程度下,本文明确列出的公开内容代替以引用方式并入本文的任何冲突材料。据称以引用方式并入本文但与本文列出的现有定义、陈述或其它公开材料相冲突的任何材料或其部分,将仅在所并入的材料与现有的公开材料之间不产生冲突的程度下并入。

Claims (19)

1.一种钉仓组件,包括:
仓体,所述仓体包括平台;
多个钉;和
可植入层,所述可植入层定位在所述平台之上,其中所述可植入层包括:
多个第一纤维,所述多个第一纤维由具有第一热转变温度的第一材料构成;和
多个第二纤维,所述多个第二纤维由具有第二热转变温度的第二材料构成,其中所述第二热转变温度低于所述第一热转变温度,其中所述第二材料与所述第一材料相互混合,并且其中在使所述层暴露于超过所述第二热转变温度的工艺温度的工艺期间,所述第二纤维在所述层内收缩。
2.根据权利要求1所述的钉仓组件,其中所述多个第二纤维被布置成结构栅格框架,并且其中所述结构栅格框架在所述工艺期间收缩。
3.根据权利要求2所述的钉仓组件,其中所述第二材料包括聚二氧六环酮。
4.根据权利要求3所述的钉仓组件,其中所述第一材料包括聚乙醇酸。
5.根据权利要求1所述的钉仓组件,其中所述可植入层是可植入层组件的一部分,所述可植入层组件还包括层压膜。
6.根据权利要求1所述的钉仓组件,其中所述工艺温度小于所述第一热转变温度。
7.一种钉仓组件,包括:
仓体,所述仓体包括平台;
多个钉;和
可植入层,所述可植入层定位在所述平台之上,其中所述可植入层包括:
网状物,所述网状物由具有第一热转变温度的第一材料构成;和
纤维,所述纤维由具有第二热转变温度的第二材料构成,其中所述第一热转变温度低于所述第二热转变温度,其中所述纤维与所述网状物交织在一起,并且其中在使所述层暴露于超过所述第一热转变温度的工艺温度的工艺期间,所述网状物收紧。
8.根据权利要求7所述的钉仓组件,其中所述第一材料包括聚二氧六环酮。
9.根据权利要求8所述的钉仓组件,其中所述第二材料包括聚乙醇酸。
10.根据权利要求7所述的钉仓组件,其中所述可植入层是可植入层组件的一部分,所述可植入层组件还包括层压膜。
11.根据权利要求7所述的钉仓组件,其中所述工艺温度小于所述第二热转变温度。
12.一种钉仓组件,包括:
仓体,所述仓体包括平台;
多个钉;和
可植入层,所述可植入层定位在所述平台之上,其中所述可植入层包括:
多个第一纤维,所述多个第一纤维由具有第一玻璃化转变温度的第一材料构成;和
多个第二纤维,所述多个第二纤维由具有第二玻璃化转变温度的第二材料构成,其中所述第二玻璃化转变温度低于所述第一玻璃化转变温度,其中所述第二材料与所述第一材料交织在一起,并且其中所述第二玻璃化转变温度先前已被超过,以使所述第二纤维收缩。
13.根据权利要求12所述的钉仓组件,其中所述第一材料包括聚二氧六环酮。
14.根据权利要求13所述的钉仓组件,其中所述第二材料包括聚乙醇酸。
15.根据权利要求12所述的钉仓组件,其中所述可植入层是可植入层组件的一部分,所述可植入层组件还包括层压膜。
16.一种制造可植入层的方法,所述方法包括以下步骤:
获得由具有第一热转变温度的第一材料构成的第一纤维;
获得由具有第二热转变温度的第二材料构成的第二纤维,其中所述第二热转变温度低于所述第一热转变温度;
将所述第一纤维与所述第二纤维相互混合;以及
将所述第二纤维加热至超过所述第二热转变温度的加工温度,使得所述第二纤维在所述相互混合步骤之后收缩。
17.根据权利要求16所述的方法,其中所述相互混合步骤包括交织所述第一纤维和所述第二纤维。
18.根据权利要求16所述的方法,其中所述加工温度不超过所述第一热转变温度。
19.根据权利要求16所述的方法,其中所述相互混合步骤包括将所述第一纤维交织到所述第二纤维的网状物中。
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US14/871,056 US10478188B2 (en) 2015-09-30 2015-09-30 Implantable layer comprising a constricted configuration
US14/871,057 US20170086829A1 (en) 2015-09-30 2015-09-30 Compressible adjunct with intermediate supporting structures
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US14/871,119 US10285699B2 (en) 2015-09-30 2015-09-30 Compressible adjunct
US14/871,071 US10433846B2 (en) 2015-09-30 2015-09-30 Compressible adjunct with crossing spacer fibers
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US14/871,056 2015-09-30
US14/871,107 US10172620B2 (en) 2015-09-30 2015-09-30 Compressible adjuncts with bonding nodes
US14/871,036 US10327777B2 (en) 2015-09-30 2015-09-30 Implantable layer comprising plastically deformed fibers
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