CN102573664B - 具有闭合机构的外科缝合器 - Google Patents

具有闭合机构的外科缝合器 Download PDF

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CN102573664B
CN102573664B CN201080045645.7A CN201080045645A CN102573664B CN 102573664 B CN102573664 B CN 102573664B CN 201080045645 A CN201080045645 A CN 201080045645A CN 102573664 B CN102573664 B CN 102573664B
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staple
shank
lower limb
nail
various embodiments
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CN102573664A (zh
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J·J·贝迪
J·P·米萨默
C·O·巴克斯特三世
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Ethicon Endo Surgery Inc
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064Surgical staples, i.e. penetrating the tissue
    • A61B17/0644Surgical staples, i.e. penetrating the tissue penetrating the tissue, deformable to closed position
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/0682Surgical staplers, e.g. containing multiple staples or clamps for applying U-shaped staples or clamps, e.g. without a forming anvil
    • A61B17/0686Surgical staplers, e.g. containing multiple staples or clamps for applying U-shaped staples or clamps, e.g. without a forming anvil having a forming anvil staying below the tissue during stapling
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B17/07207Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously the staples being applied sequentially
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B2017/07214Stapler heads
    • A61B2017/07257Stapler heads characterised by its anvil
    • A61B2017/07264Stapler heads characterised by its anvil characterised by its staple forming cavities, e.g. geometry or material
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B2017/07214Stapler heads
    • A61B2017/07285Stapler heads characterised by its cutter

Abstract

本发明公开了一种外科缝合器,所述外科缝合器包括第一柄部和第二柄部,所述第一柄部包括被构造成接纳钉仓的钉仓通道,所述第二柄部包括砧座。所述缝合器还包括可旋转闩锁和闩锁凸起,其中所述闩锁可旋转地连接到所述第一柄部和所述第二柄部中的一个,并且其中所述闩锁凸起从所述第一柄部和所述第二柄部中的另一个延伸。所述闩锁被构造成接合所述闩锁凸起以使所述第一柄部和所述第二柄部彼此相向运动。在多种实施例中,所述闩锁凸起包括可旋转轴承,其中所述闩锁被构造成当所述闩锁接合所述闩锁凸起时接触所述可旋转轴承。

Description

具有闭合机构的外科缝合器
相关专利申请的交叉引用
根据美国法典第35章第119(e)条的规定,本非临时性专利申请要求提交于2009年10月9日的名称为“SURGICAL STAPLER”(外科缝合器)的美国临时专利申请No.61/250,377的优先权,该临时专利申请的全部公开内容以引用的方式并入本文。
背景技术
i.技术领域
本发明涉及缝合器械,并且在多种实施例中,涉及用于制备一排或多排缝钉的外科缝合器械。
ii.背景技术
近年以来,外科医生越来越倾向于使用缝合器械缝合身体组织,例如肺、食道、胃、十二指肠和/或肠道中的其他器官。在多种情况下使用适当的缝合器械可用更短的时间将手术做得更出色,并简化此前困难的外科手术,例如胃肠吻合术。早先的直线双排和四排切割缝合器包括将缝钉单独手动加载到其中的无钉仓器械。其他早先的器械包括预消毒的一次性缝钉加载单元和切割构件,其可用于同时分割组织并将各排缝钉成形。这种外科缝合器的实例在公布于1970年3月10的名称为“INSTRUMENT FOR PLACING LATERALGASTROINTESTINAL ANASTOMOSES”(用于进行横向胃肠吻合的器械)的美国专利No.3,499,591中有所公开,该专利的全部公开内容以引用的方式并入本文。
缝合器械可包括一对配合的细长钳口构件,其中每个钳口构件均可用于插入要吻合的内部管状身体器官内。在多种实施例中,钳口构件中的一个可支承具有至少两个横向间隔的缝钉排的钉仓,同时另一个钳口构件可支承与钉仓中的缝钉排对准的具有缝钉成形凹腔的砧座。一般来讲,缝合器械还可包括可相对于钳口构件而滑动的推杆和刀片,以通过推杆上的凸轮表面将缝钉从钉仓中依次顶出。在至少一个实施例中,凸轮表面可被构造成启动由钉仓承载并与各个缝钉相随的多个缝钉驱动器,以推压缝钉靠在砧座上并在夹持在钳口构件之间的组织内形成横向间隔的变形缝钉排。然而,在典型的缝合器械中,一旦将钳口构件组装在一起就无法相对于钉仓移动砧座,并且无法调整已形成的缝钉高度。在至少一个实施例中,刀片可跟随推杆并沿着缝钉排之间的路线切割组织。此类缝合器械的实例在公布于1984年2月7日的名称为“SURGICAL INSTRUMENTS”(外科器械)的美国专利No.4,429,695中有所公开,该专利的全部公开内容据此以引用方式并入本文。
发明内容
在本发明的至少一种形式中,外科缝合器可包括具有被构造成接纳钉仓的钉仓通道的第一柄部,以及具有砧座的第二柄部。缝合器还包括可旋转的闩锁和闩锁凸起,其中闩锁可旋转地连接到第一柄部和第二柄部中的一个,并且其中闩锁凸起从第一柄部和第二柄部的另一个延伸。闩锁被构造成接合闩锁凸起以使第一柄部和第二柄部彼此相向运动。在多种实施例中,闩锁凸起包括可旋转轴承,其中闩锁被构造成当闩锁接合闩锁凸起时与可旋转轴承接触。
在本发明的至少一种形式中,外科缝合器可包括砧座,其具有在组织接触表面中形成的多个缝钉凹腔。每个缝钉凹腔可具有纵向轴线、第一成形杯和第二成形杯。第一成形杯可包括具有基本上垂直于组织接触表面的第一垂直部分的第一内侧壁。第二成形杯可包括具有基本上垂直于组织接触表面的第二垂直部分的第二内侧壁。在多种实施例中,第一垂直部分和第二垂直部分可延伸穿过纵向轴线,其中第一内侧壁和第二内侧壁可构成用于使缝钉的第一钉腿变形至纵向轴线的第一侧以及用于使缝钉的第二钉腿变形至纵向轴线的第二侧的夹钉部。
在本发明的至少一种形式中,提供了一种用于使缝钉变形的方法,该缝钉包括基部、第一钉腿和第二钉腿,其中在进行变形之前将基部、第一钉腿和第二钉腿定位在共同平面内,该方法包括:将第一钉腿定位在缝钉凹腔的第一杯内,该第一杯包括第一内平面,将第一挤压力施加于第一钉腿的末端以使第一钉腿朝基部和第二钉腿弯曲,使第一内表面与第一钉腿的末端接触以使第一钉腿的末端朝基部的第一侧面弯曲,以及使第一钉腿变形以使得第一钉腿的末端横跨限定在第一钉腿和第二钉腿之间的中线。
附图说明
通过结合附图参考本发明实施例的以下说明,本发明的上述和其他特征及优点及其获取方法将会变得更加明显,并可更好地理解发明本身,其中:
图1为根据本发明的至少一个实施例的外科缝合器械的透视图;
图2为图1的外科缝合器械的分解透视图;
图3为图1的外科缝合器械的分解正视图;
图4为图1的外科缝合器械的局部剖视图,其示出被组装在一起的第一和第二部分;
图5为图1的外科缝合器械的局部剖视图,其示出被锁定于图4的第二部分近端的图4的第一部分近端并示出朝第一部分旋转的第二部分;
图6为图1的外科缝合器械的局部剖视图,其示出可旋转地安装于第一部分的闩锁,其中闩锁与第二部分接合并且其中闩锁已旋转至部分关闭位置;
图7为图1的外科缝合器械的局部剖视图,其示出位于关闭位置的图6的闩锁;
图8为图1的外科缝合器械的钉仓组件的透视图;
图9为图8的钉仓组件的分解图;
图10为沿着图9的线10-10截取的图8钉仓组件的剖视图;
图11为图8钉仓组件的缝钉滑轨与切割构件组合的分解图;
图12为图11的缝钉滑轨与切割构件组合的透视图;
图13为图1的外科缝合器械的透视图,其示出沿着外科缝合器械的第一侧面向远侧移动的击发致动器;
图14为图1的外科缝合器械的透视图,其示出沿着外科缝合器械的第二侧面向远侧移动的图13的击发致动器;
图15为根据本发明的至少一个可供选择的实施例的外科缝合器械的剖视图,其示出位于部分关闭位置的闩锁以及与击发致动器接合的锁定机构;
图16为图15的外科缝合器械的剖视图,其中闩锁已移至关闭位置并且已使锁定机构脱离击发致动器;
图17为图1的外科缝合器械的砧座组件的透视图;
图18为图17的砧座组件的分解透视图;
图19为图17的砧座组件的另一个分解透视图;
图20为图17的砧座组件的分解的剖切正视图;
图21为图17的砧座组件的剖视组装图,其示出位于第一位置的砧座调整构件;
图22为图17的砧座组件的剖视组装图,其示出位于第二位置的图21的砧座调整构件;
图23为图17的砧座组件的剖视组装图,其示出位于第三位置的图21的砧座调整构件;
图24为根据本发明的至少一个可供选择的实施例的外科缝合器械的透视图;
图25为沿着图24中的线25-25截取的图24的外科缝合器械的剖视图;
图26为图24的外科缝合器械近端的局部分解图,该器械近端包括用于以可脱开的方式使可旋转的砧座调整构件固定就位的制动机构;
图27为图24的外科缝合器械的透视图,其中某些部件被移除而其他部件以剖视示出;
图28为图24的外科缝合器械诸部分的分解图,其示出处于第一取向的可旋转砧座调整构件;
图29为图28的可旋转砧座调整构件的透视图;
图30为图24的外科缝合器械的端视图,其中某些部件被移除而其他部件以虚线示出,其示出处于图28的第一取向的可旋转砧座调整构件;
图31为沿着图24中的线31-31截取的图24的外科缝合器械的剖切端视图;
图32为图24的外科缝合器械的端视图,其示出以第一方向旋转至第二取向的图28的可旋转砧座调整构件;
图33为图24的外科缝合器械的剖切端视图,其示出处于图32的第二取向的砧座调整构件;
图34为图24的外科缝合器械的端视图,其示出以第二方向旋转至第三取向的图28的可旋转砧座调整构件;
图35为图24的外科缝合器械的剖切端视图,其示出处于图34的第三取向的砧座调整构件;
图36为用于旋转图28的砧座调整构件的致动器的透视图;
图37为外科缝合器械的局部剖视图,该器械包括弹簧,其被构造成当缝合器械处于部分闭合构型时使第一柄部的远端偏离第二柄部的远端;
图38为类似于图17的图1的外科缝合器械的透视图;
图39为从根据本发明的至少一个可供选择的实施例的外科缝合器械的砧座延伸的闩锁凸起的细部图;
图40为示意图,其示出图39的闩锁凸起以及被构造成接合闩锁凸起并将闩锁凸起移至闩锁凹陷内的闩锁;
图41为图39的闩锁凸起的正视图;
图42为根据本发明的至少一个实施例的缝钉凹腔的透视图;
图43为图42的缝钉凹腔的俯视图;
图44为沿着图43中的线44-44截取的图42的缝钉凹腔的剖视图;
图45为沿着图43中的线45-45截取的图42的缝钉凹腔的剖视图;
图46为图42的缝钉凹腔的另一个俯视图;
图47为沿着图46中的线47-47截取的图42的缝钉凹腔的剖视图;
图48为沿着图46中的线48-48截取的图42的缝钉凹腔的剖视图;
图49为未变形形状的手术缝钉的正视图;
图50为根据本发明的至少一个实施例的变形后形状的图49的手术缝钉的正视图;
图51为图50的变形后形状的图49的手术缝钉的侧视图;
图52为图50的变形后形状的图49的手术缝钉的平面图;
图52A为图50的变形后形状的图49的手术缝钉的另一个平面图;
图53为未变形形状的手术缝钉的正视图;
图54为未变形形状的图53的手术缝钉的仰视图;
图55为根据本发明的至少一个实施例的变形后形状的图53手术缝钉的仰视图;
图56为图53的手术缝钉的局部剖视图;
图57为根据本发明的至少一个实施例的变形后形状的手术缝钉的正视图;以及
图58为变形后形状的手术缝钉的正视图。
对应参考符号表明贯穿若干视图的对应部分。本文示出的范例(以一种形式)示出本发明的优选实施例,不应将这种范例理解为是以任何方式限制本发明的范围。
具体实施方式
现在将描述一些示例性实施例以全面理解本申请公开的装置的结构原理、功能、制造和器械用途以及方法。这些实施例的一个或多个实例在附图中示出。本领域的普通技术人员将会理解,本文特别描述和在附图中示出的器械和方法为非限制性的示例性实施例,并且本发明多个实施例的范围仅由权利要求书限定。一个示例性实施例示出或描述的特征可以与其他实施例的特征组合。这种修改形式和变型形式旨在包括在本发明的范围内。
以下共同拥有的非临时性美国专利申请的全部公开内容据此以引用的方式并入本文:
“SURGICAL STAPLING INSTRUMENT WITH CUTTINGMEMBER ARRANGEMENT”(具有切割构件装置的外科缝合器械),代理人案卷号为END6414USNP/080203的美国专利申请No.12/234,149;
“SURGICAL STAPLER WITH APPARATUS FOR ADJUSTINGSTAPLE HEIGHT”(具有用于调整缝钉高度的装置的外科缝合器),代理人案卷号为END6406USNP/080195的美国专利申请No.12/234,133;
“LOCKOUT ARRANGEMENT FOR A SURGICAL STAPLER”(外科缝合器的闭锁装置),代理人案卷号为END6405USNP/080194的美国专利申请No.12/234,113;
“SURGICAL STAPLER HAVING AN INTERMEDIATE CLOSINGPOSITION”(具有中间闭合位置的外科缝合器),代理人案卷号为END6411USNP/080200的美国专利申请No.12/234,143;
“A METHOD FOR FORMING A STAPLE”(使缝钉成形的方法),其随同本专利申请于同一天提交,代理人案卷号为END6614USNP/090244;以及
“SURGICAL STAPLER COMPRISING A STAPLE POCKET”(具有缝钉凹腔的外科缝合器),其随同本专利申请于同一天提交,代理人案卷号为END6613USNP/090243。
参见图1,外科缝合器械(通常为100)可包括第一柄部102和第二柄部104。在多种实施例中,第一柄部102和第二柄部104被构造成能够例如由外科医生抓握,并可包括手持部分106。在至少一个实施例中,第一柄部102(参见图2和3)可包括附装于第一支架110的第一覆盖件108,并且类似地第二柄部104可包括附装于第二支架114的第二覆盖件112。覆盖件108和112可以具有符合人体工程学的轮廓,或以其他方式具有合适轮廓,以帮助外科医生在手术部位内操作缝合器械100。在多种实施例中,柄部覆盖件108和112例如可分别包括增大的突出部109和113,其可有助于将缝合器械100插入手术部位内。在多种实施例中,柄部覆盖件108和112可例如由塑性轻质材料和/或任何其他合适的材料制成,而柄部支架110和114可例如由不锈钢、钛和/或任何其他合适的材料制成。
在多种实施例中,再次参见图1-3,柄部102和104的远端可包括端部操纵装置120,其可被构造成例如可对手术部位内的组织进行处理。在至少一个这种实施例中,端部操纵装置120可包括被构造成接纳和/或保持钉仓的钉仓通道122,如下文更详细地进一步描述。在某些实施例中,钉仓通道122可包括从第一柄部支架110延伸的一体式细长通道形支架。在至少一个实施例中,钉仓通道122可包括由底壁126所连接的一对相对的细长侧壁124。沿着钉仓通道122的向后或近侧部分,一对间隔开的直立侧面凸缘128可从相对侧壁124向上延伸。在多种实施例中,侧面凸缘128之间的钉仓通道122的宽度可大于从第二柄部104延伸的上部钳口构件或砧座130的宽度。在至少一个实施例中,凸缘128之间的距离可被构造成在缝合器械为进行手术而被组装时允许在侧面凸缘128之间接纳砧座130的至少一部分。如图2所示,每个侧面凸缘128均可包括例如凹口或凹陷127,其可被构造成接纳例如从砧座130和/或第二柄部104的任何其他合适的部分延伸的一个或多个闩锁凸起131,如下文更详细地进一步描述。
如上文指出,再次参见图1-3,钉仓通道122可被构造成例如在端部操纵装置120内支承和/或保持钉仓,例如钉仓150,其中钉仓可包括可取出地存放于其中的一个或多个缝钉(未示出)。在多种实施例中,参见图8-10,钉仓150可包括一个或多个钉腔151,其可采用任何合适的方式配置来存放缝钉,例如采用例如至少两个横向间隔的纵排的形式。在至少一个实施例中,参见图9和10,钉仓150可包括钉仓主体152和底盘154,其中钉仓主体152和/或底盘154可被构造成限定用于在其中可滑动地接纳缝钉滑轨和/或切割构件的通道或通路。在至少一个实施例中,底盘154可例如包括柔性臂155,其可被构造成以扣合和/或压合结构来接合钉仓主体152。参见图10-12,钉仓150还可包括缝钉滑轨组件160,其可包括缝钉滑轨部分162,此外还包括切割构件164。在多种实施例中,切割构件164可例如包括刀刃165和锁臂166,其中锁臂166可被构造成在切割构件164组装到缝钉滑轨部分162时被压合和/或扣合进缝钉滑轨162中的孔163内。在其他多个实施例中,缝钉滑轨部分162可整体模制在切割构件164上。
除了上文所述,参见图8-10,钉仓主体152可包括狭槽,举例来说如狭槽156,其可被构造成在其中接纳切割构件164的至少一部分,和/或缝钉滑轨组件160以及推杆组件200(在下面进行讨论)的任何其他部分,其中狭槽156可被构造成允许切割构件164在钉仓150内的第一和第二位置之间移动。在多种实施例中,狭槽156可被构造成例如允许切割构件164在近侧位置(图10)和远侧位置之间移动以便切割定位在钉仓150和砧座130中间的组织。再参见图10-12,缝钉滑轨部分162可包括凸轮、滑道或致动器表面167,其可被构造成接合定位在钉仓150内的缝钉驱动器。在多种实施例中,参见图9,钉仓150可包括缝钉驱动器168,其可通过滑座部分162在钉腔151内向上提起或滑动,使得缝钉驱动器168的向上移动可顶出或调配至少部分地设置在钉腔151内的缝钉。虽然缝钉驱动器168事实上可垂直向上提起,但术语“向上”等等可表示例如使缝钉驱动器168例如朝钉仓的顶面即平台158和/或朝砧座130移动。在某些实施例中,如图9所示,每个缝钉驱动器168可包括以与凸轮表面167相同的角度和/或任何其他合适的角度取向的一个或多个倾斜表面169,其可在缝钉滑轨162和缝钉驱动器168之间提供相对平坦或至少基本上平坦的滑动接触表面。在多种实施例中,缝钉驱动器可被构造成仅调配一个缝钉,而在某些实施例中,缝钉驱动器可被构造成例如同时调配位于相邻排中的两个或多个缝钉。其他装置在提交于2008年2月13日的名称为“SURGICAL STAPLING INSTRUMENT WITH IMPROVED FIRINGTRIGGER ARRANGEMENT”(带有改进的击发扳机装置的外科缝合器械)的美国专利申请No.12/030,424中有所公开,该专利申请的全部公开内容以引用的方式并入本文。
在多种实施例中,如上所述,外科缝合器械可包括被构造成切割组织和调配钉仓中的缝钉的切割构件/缝钉滑轨组件。然而,在某些实施例中,外科缝合器械可能不需要或包括切割构件。在至少一个这种实施例中,钉仓可包括设置在其中的缝钉滑轨,并且/或者外科器械可被构造成使缝钉滑轨移至钉仓内以便缝合组织,而例如不另外将组织切开。在某些其他实施例中,钉仓可包括设置在其中的缝钉滑轨,其中外科器械可包括可移至钉仓内或相对于钉仓移动的切割构件。在至少一个这种实施例中,切割构件可行进至与缝钉滑轨接触,使得切割构件和缝钉滑轨可一起被推进。其后,可以充分地退回切割构件以允许钉仓脱离外科器械并由具有新缝钉滑轨的新钉仓替代。当缝钉滑轨在使用过程中可能被磨损或变形时此类实施例可能是可用的。可预想到其他实施例,其中钉仓可包括设置在其中的切割构件,其中外科器械可包括可移至钉仓内或可相对于钉仓移动的缝钉滑轨。在至少一个这种实施例中,与上文所述类似,缝钉滑轨可行进至与切割构件接触,使得切割构件和缝钉滑轨可一起被推进。其后,可以充分地退回缝钉滑轨以允许钉仓脱离外科器械并由具有新切割构件的新钉仓所替代。当切割构件在使用过程中可能被磨损或变形时此类实施例可能是可用的。在多种实施例中,如下文更详细描述,钉仓可包括保护壳体或覆盖件,其被构造成能防止或至少降低例如当外科医生或其他临床医生抓握钉仓时触摸设置在钉仓中的切割构件的可能性。
在多种实施例中,除了上文所述,钉仓通道122和/或钉仓150例如可包括例如一个或多个配合的凸起和/或凹陷,其可被构造成使钉仓150可移动地保持在钉仓通道122内。在多种实施例中,一旦将钉仓150插入钉仓通道122内,就可将第一柄部102组装到第二柄部104上。在其他多个实施例中,第一和第二柄部组装在一起之后可将钉仓插入钉仓通道内。无论哪一种情况,参见图1-7,第一柄部102和第二柄部104可分别包括近端103和105,其可被组装在一起,使得第一柄部和第二柄部可被旋转或枢转地彼此联接。在多种实施例中,参见图2和3,第一柄部102可包括从中延伸的一个或多个销或凸起111,其可被构造成滑动地接纳于第二柄部104中的一个或多个凹槽、沟槽或狭槽115内。在某些实施例中,狭槽115可被限定于第二柄部支架114中并且凸起111可从例如近端柱107(其从第一柄部110延伸)延伸。为了组装第一柄部102和第二柄部104,参见图4,狭槽115的开口端可与凸起111对准,使得例如第二柄部104可相对于第一柄部102平移,并且凸起111可在狭槽115内滑动。在至少一个实施例中,如图2和3所示,狭槽115的开口端可相对于其闭合端位于近侧。在至少一个这种实施例中,第二柄部104的近端105可相对于第一柄部102的近端103设置在远侧,使得第二柄部104可向近侧移动以便将凸起111定位在狭槽115内。在多种其他情况下,第一柄部102可相对于第二柄部104设置在近侧并向远侧滑动以便将凸起111定位在狭槽115内。
在多种实施例中,参见图5,第二柄部104可朝第一柄部102旋转,使得砧座130可相对于钉仓150和/或钉仓通道122移动就位。在某些实施例中,第一柄部102可朝第二柄部104旋转和/或第一和第二柄部可朝彼此旋转。在任何情况下,凸起111和狭槽115彼此接合时可构成枢轴,第一和第二柄部的一者或两者可相对于彼此绕该枢轴动作。在多种实施例中,第二柄部104可相对于第一柄部102移动,使得砧座130移至与钉仓150紧密相对的位置。在某些实施例中,参见图6,第二柄部104可相对于第一柄部102移动,使得从第二柄部104延伸的闩锁凸起131可与第一柄部102内的凹陷127对准和/或插入凹陷127内。在多种实施例中,主要参见图2和3,第一柄部102还可包括可旋转地安装于其上的闭锁机构180,其可用于接合从第二柄部104延伸的闩锁凸起131并将第一和第二柄部固定在一起。虽然未作图示,但可预见到其他实施例,其中闭锁机构可旋转地安装于第二柄部并且闩锁凸起可从第一柄部延伸。在任何情况下,在至少一个实施例中,闭锁机构180可通过一个或多个枢轴销182安装于第一支架110,枢轴销182可被构造成限定闩锁180能够绕其旋转的轴线。
在某些实施例中,现在参见图4和5,闭锁机构180可包括闩锁支架184,此外还包括组装至闩锁支架184的闩锁覆盖件186。在其他多个实施例中,闩锁覆盖件和闩锁支架可构成整体单元,或在某些实施例中,闭锁机构可甚至不包括覆盖件。在某些实施例中,闩锁支架184可为通道形状并且可包括一对相对的细长侧壁185,其以足以跨越第一支架部分110的距离间隔开。在至少一个实施例中,闩锁覆盖件186可例如由塑性轻质材料和/或任何其他合适的材料制成,而闩锁支架184可例如由不锈钢和/或任何其他合适的材料制成。在某些实施例中,当闭锁机构180关闭时,如图7所示,闩锁覆盖件186可与第一柄部覆盖件108对准。闩锁覆盖件186可包括轮廓部分187,其可被构造成有助于外科医生操作外科器械100,其中在至少一个实施例中,轮廓部分187可与从第一柄部覆盖件108延伸的突出部109对准或至少基本上与其对准。闭锁机构180还可包括从中延伸的一个或多个闩锁臂188,其可被构造成接合从第二柄部104延伸的一个或多个闩锁凸起131并将凸起131拉引和/或固定于凹陷127内,如图7所示。在至少一个实施例中,至少一个闩锁臂188可与闩锁支架184一体地形成。在某些实施例中,参见图6,至少一个闩锁臂188可包括远端钩189,其可被构造成环绕凸起131的至少一部分,以包围或包裹、或至少部分地包围或包裹凸起131。在至少一个实施例中,闩锁臂188可充当偏心闩锁以使闭锁机构180保持在其锁闭或关闭位置。
在使用中,在多种情况下,第一柄部102和第二柄部104的一者可定位在手术部位内的组织的第一侧,同时另一柄部可转到所述组织的对侧就位。在此类实施例中,钉仓150可定位在组织的一侧并且砧座130可定位在组织的另一侧。此后,亦如上文所作概述,可致动闭锁机构180使得其可在打开位置和关闭位置之间移动,以便将第二柄部104锁闭至第一柄部102并对设置在钉仓150和砧座130之间的组织施加夹紧力。在某些情况下,闭锁机构180可在打开位置(图5)、部分关闭或中间位置(图6)和关闭位置(图7)之间移动。在至少一个这种实施例中,参见图5和6,闭锁机构180可在其中闩锁臂188未与凸起131接合的打开位置和其中闩锁臂188与凸起131接合的部分关闭位置之间移动,使得尽管已使砧座130至少部分地与钉仓150相对,但砧座130和钉仓150之间可留有足够间隙,从而可允许例如端部操纵装置120相对于组织重新定位。一旦砧座130和钉仓150已相对于组织充分地定位,闭锁机构180就可在其部分关闭位置和关闭位置之间移动,如图7所示。
在多种实施例中,除了上文所述,外科缝合器械还可包括偏置构件,其可被构造成使缝合器械的第一柄部偏离第二柄部。在至少一个实施例中,如下文更详细地进一步描述,弹簧和/或任何具有合适回弹力的材料可设置在第一和第二柄部之间,使得缝合器械的砧座和钉仓可偏离彼此。在某些实施例中,弹簧可被构造成至少部分地分离第一和第二柄部,使得砧座和钉仓之间存在间隙,其中间隙可足以使组织能够设置在其间。在使用中,外科医生可定位此类外科缝合器械,而不必使第一和第二柄部分离并保持彼此分开。当缝合器械处于部分封闭构型并且外科医生正在手术部位内操作该器械时,此类器械可能特别有效。在外科医生对缝合器械的定位感到满意之后,外科医生可压缩弹簧和/或使弹簧脱开并将缝合器械布置成封闭构型。
在多种情况下,如上面所概述,第一柄部102的远端可相对于第二柄部104的远端移动,特别是在闭锁机构180与第二柄部104的凸起131未接合或仅部分地接合时。在此类情况下,位于第一和第二柄部近端的凸起111和狭槽115可被构造成例如当第一和第二柄部的远端相对于彼此移动时使至少第一和第二柄部的近端保持在一起。换句话讲,凸起111和狭槽115可相配合以防止或至少阻碍第一柄部102与第二柄部104完全分离。在某些实施例中,第一柄部可包括第一锁扣部,同时第二柄部可包括第二锁扣部,其中第一和第二锁扣部可被构造成彼此接合并防止第一柄部与第二柄部完全分离。在至少一个实施例中,凸起111可构成第一锁扣部并且狭槽115可构成第二锁扣部。先前的缝合器械缺少此类锁扣部,相反其依靠唯一的闭锁机构使第一和第二柄部保持在一起。在这类情况下,其中这些先前的缝合器械的闭锁机构未与第一和第二柄部两者完全接合,第一和第二柄部可能会彼此完全分离,因此例如需要外科医生重新定位并重新组装柄部。在某些情况下,这些之前缝钉的第一和第二柄部的完全分离可暴露切割构件的至少一部分。
在多种实施例中,如上面所概述,闭锁机构180可被构造成在打开位置、部分关闭位置和关闭位置之间移动。当闭锁机构180位于其打开位置时,亦如上文所作概述,凸起111可插入狭槽115中和/或从狭槽115中退出。当闭锁机构180位于其部分关闭位置时,参见图6,闩锁臂188可被构造成接合闩锁凸起131,使得无法从狭槽115中退出凸起111。在至少一个这种实施例中,闩锁臂188和闩锁凸起131可被构造成能防止或至少阻碍第二柄部104相对于第一柄部102向远侧移动,并因此防止或至少阻碍凸起111从狭槽115脱开。相应地,闩锁臂188和闩锁凸起131可被构造成能防止第一柄部102相对于第一柄部104向近侧移动。与上文所述类似,在多种实施例中,闩锁臂188和闩锁凸起131也可被构造成当闭锁机构180位于其关闭位置(图7)时防止或至少阻碍凸起111从狭槽115退出。在某些实施例中,除了上文所述,闩锁凸起131可从第二柄部104的位于其近端和远端中间的位置延伸。在至少一个这种实施例中,凸起111和狭槽115可被构造成使第一和第二柄部在其近端保持在一起,而闭锁机构180可用于使第一和第二柄部在中间位置保持在一起。在任何情况下,在某些实施例中,第一和第二柄部均无法彼此脱开,除非闭锁机构180被移至其完全打开位置。在至少一个这种实施例中,当闭锁机构180位于关闭和/或部分关闭位置时,凸起111和狭槽115无法从彼此脱开。
砧座130和钉仓150一旦被充分定位,设置在砧座130和钉仓150中间的组织就可被缝合和/或切割。在多种实施例中,参见图3,外科缝合器械100还可包括推杆组件200,其可被构造成例如使缝钉滑轨组件160在钉仓150内推进和/或退回。在至少一个实施例中,推杆组件200可包括推杆202和击发致动器204,其中击发致动器204可被构造成使推杆202和缝钉滑轨组件160向远侧移动以从钉仓150调配缝钉并使缝钉靠在砧座130上变形,如上所述。在至少一个实施例中,参见图11和12,缝钉滑轨162可包括凹槽、沟槽或狭槽161,其可被构造成接纳推杆202的远端201(图3)并且能够可操作地连接到远端201。在某些实施例中,将钉仓150插入钉仓通道122中时,缝钉滑轨组件160能够可操作地与推杆202接合。在至少一个实施例中,远端201和狭槽161可包括配合结构,其可使远端201和狭槽161能够在横向上组装,但防止或至少阻碍远端201和狭槽161在近侧方向和/或远侧方向上彼此分离。在其他实施例中,推杆202在接触并接合缝钉滑轨组件160之前可向远侧推进。在至少一个这种实施例中,缝钉滑轨组件160可保持静止,直至被推杆202接触到为止。在任何情况下,如上文概述,致动器204能够被可操作地连接到推杆202,使得推力和/或拉力可被施加于致动器204并传递到推杆202。在某些实施例中,如下文更详细描述,致动器204可被可枢转地连接到推杆202的近端203,使得致动器204可在至少第一和第二位置之间有选择地旋转。
除了上文所述,参见图1、13和14,致动器204可在外科缝合器械100(图13)的第一侧面116上的第一位置、第二侧面117(图14)上的第二位置以及位于第一柄部102的近端103和第二柄部104的近端105的中间位置(图1)之间移动。一旦使致动器204在第一侧面116和第二侧面117的一者上转到位置,就可将致动器204向远侧推进。在多种情况下,因此,外科医生可选择是使致动器204沿着第一侧面116还是第二侧面117向远侧移动。可能会出现此类情况:例如当致动器204沿着外科器械的一侧向远侧移动时,与另一侧相比,此时致动器204更可能紧密接触到手术部位周围的组织上。在多种实施例中,参见图2和3,致动器204可包括从中延伸的臂206,其中臂206可以被可枢转地安装于推杆202的近端203。在某些实施例中,再次参见图1、13和14,外科器械100可包括沿着第一侧面116延伸的第一狭槽(未示出)和沿着第二侧面117延伸的第二狭槽118,其中第一和第二狭槽可被构造成滑动地接纳致动器204的至少一部分。在至少一个实施例中,第一和第二狭槽的侧壁可限制或至少帮助限制致动器204的移动,使得其可沿着预定路径移动。参见图14,第二狭槽118例如可被限定于第一柄部102和第二柄部104之间,使得当致动器204沿着第二侧面117向远侧移动时,致动器204的臂206可在第一和第二柄部中间滑动。与上文所述类似,第一狭槽也可被限定于第一和第二柄部中间。在多种实施例中,再次参见图13和14,外科器械100还可包括中间狭槽119,其也可被构造成使臂206和/或致动器204的任何其他合适部分能够在其中滑动。在至少一个这种实施例中,中间狭槽119可连接第一和第二狭槽,使得当致动器204定位在其中间位置时,致动器204可被移入第一和第二位置中的任何一者。在某些实施例中,第一狭槽、第二狭槽117和中间狭槽119可彼此平行或至少基本上平行和/或位于相同平面内,然而可预想到其他实施例,其中狭槽中的一者或多者与其他狭槽不平行和/或位于不同平面内。此外,尽管图示实施例的第一和第二侧面位于外科器械100的相对侧上,然而可预想到其他实施例,其中第一和第二狭槽例如位于相邻侧面和/或彼此不正对的侧面上。此外,可预想到其他实施例,其中缝合器械的侧面不易于分辨,例如具有圆形和/或弧形部分的器械。
在多种实施例中,除了上文所述,外科缝合器械100还可包括锁定机构,其可防止或至少阻碍致动器204和相应的缝钉滑轨组件160过早被推进。在至少一个实施例中,锁定机构可被构造成在闭锁机构180进入关闭或至少部分关闭位置之前防止或至少阻碍致动器204向远侧推进。在某些实施例中,总体参见图5,外科缝合器械100还可包括锁定机构220,其可与致动器204接合并可在闭锁机构180处于完全打开位置(图5)和/或至少基本上打开位置时仍然与致动器204接合。在多种实施例中,锁定机构220可包括锁扣222,其可在例如由锁扣弹簧224施加至其上的偏置力作用下偏压至与致动器204接合。在至少一个这种实施例中,致动器204可包括一个或多个凹槽、沟槽或狭槽(未示出),其可被构造成接纳锁扣222的至少一部分。在使用中,锁定机构220可使致动器204固定就位,直至闭锁机构180进入其完全关闭位置(图7)和/或至少基本上关闭位置。在此类情况下,在至少一个实施例中,闭锁机构180可被构造成接合锁定机构220并使锁扣222从致动器204脱开。在至少一个这种实施例中,参见图5-7,闭锁机构180还可包括凸轮183,其可被构造成当闭锁机构180进入其关闭位置时接合锁扣222上的凸轮表面223,并因此使锁扣222从致动器204滑开和/或以其他方式移开。在多种实施例中,凸轮183可包括从闩锁覆盖件186和/或闩锁支架184延伸的壁、肋和/或脊。在任何情况下,一旦锁扣222充分从致动器204脱开,在至少一个实施例中,致动器204就可从图1所示的其中间位置进入图13和14所示的其第一和第二位置之一。
如上所述,锁定机构220可被构造成例如在闭锁机构180进入例如关闭位置和/或部分关闭位置等预定位置之前,防止或至少阻碍驱动杆202向远侧推进。有利的是,锁定机构220也可在将第一柄部102和第二柄部104组装在一起之前,防止或至少阻碍缝钉滑轨组件160推进。事实上,锁定机构220可防止定位在砧座130和钉仓150中间的组织在砧座130和钉仓150相对于该组织正确定位之前被切割和/或缝合。另外,事实上,锁定机构220可防止缝钉在对组织施加适当的夹紧力之前被调配至组织。在任何情况下,当闭锁机构180返回其完全打开位置和/或部分打开位置时,凸轮183可从锁扣222移开,使得锁扣弹簧124可再一次将锁扣222偏压至与致动器204接合。在多个其他实施例中,参见图15和16,锁定机构220’可包括具有凸轮表面223’的锁扣222’,此外还包括可限制锁扣222’相对移动的止挡226’。在至少一个实施例中,凸轮183例如可被构造成能够接触到凸轮表面223’,并且由于凸轮表面223’的带轮廓的、斜切的和/或倾斜的表面,凸轮183可被构造成向远侧推动锁扣222’,如图16所示。可向远侧推动锁扣222’,使得从锁扣222’延伸的销228’可在第一位置(图15)和第二位置(图16)之间移动,其中位于第一位置时其定位在致动器204’的孔229’内,而位于第二位置时销228’已从孔229’充分退出。在多种实施例中,止挡226’可被构造成使得向远侧推动锁扣222’时,一旦锁扣222’充分移位,止挡226’就可与凸轮183接触。在此类实施例中,止挡226’可被构造成控制锁扣222’的第二位置即已移位的位置。与上文所述类似,当致动器180移出其关闭位置并且凸轮183已脱开锁定机构220’时,锁扣弹簧224’可再次使锁扣222’移至与致动器204’接合。
在多种实施例中,如上所述,可利用击发致动器在第一和第二位置之间移动推杆、缝钉滑轨和/或切割构件。如上另外所述,推杆组件200例如可用于例如在近侧位置(图10)和远侧位置之间移动缝钉滑轨组件,例如缝钉滑轨组件160。在某些实施例中,钉仓150之类的钉仓例如可包括包含在其中的缝钉滑轨组件160,其中缝钉滑轨组件160可在钉仓组装至或插入钉仓通道122内时定位在远侧位置,如图10所示。在至少一个这种实施例中,参见图8-10,钉仓150还可包括壳体170,其可被构造成例如当缝钉滑轨组件160位于其远侧位置时覆盖切割构件164的至少一部分。在多种实施例中,壳体170可被构造成例如在抓握钉仓时、将钉仓插入外科缝合器和/或将外科缝合器的两个或更多个部分组装在一起时对外科医生进行保护。在至少一个这种实施例中,刀刃165的至少上部可伸到钉仓150的平台或顶面158之上,并且如果缺少保护壳体例如壳体170,刀刃165的上部可能会外露。
在多种实施例中,如上所述,切割构件165可至少部分地设置在狭槽或通道156内,并且如图10所示,切割构件164的至少上部或顶部可延伸到平台158以上。在至少一个实施例中,参见图8-10,壳体170可包括从钉仓主体152的第一部分157延伸的第一侧壁或部分172,从钉仓主体152的第二部分159延伸的第二侧壁或部分174,以及在第一侧壁172和第二侧壁174之间延伸的顶壁或顶部176。在某些实施例中,壳体可包括仅一个从钉仓主体延伸的支承壁或支承部分,此外还包括从其延伸的顶壁或顶部。在其他实施例中,壳体可包括一个或多个侧壁或部分,并且不包括顶壁。在至少一个这种实施例中,壳体的侧壁可被构造成例如使得它们延伸到切割构件的顶部以上,或至少延伸到切割构件的刀刃以上。在任何情况下,如图10所示,当缝钉滑轨组件160位于其近侧位置时,切割构件164的至少一部分可设置在顶壁176下面和/或侧壁172和174之间。在某些实施例中,切割构件164可完全设置在顶壁176下面,和/或完全设置在壳体170内。在至少一个实施例中,切割构件164可设置在顶壁176下面,使得切割面165不延伸于顶壁176的远侧边缘175和/或近侧边缘177之外。在至少一个实施例中,壳体170可包括后壁178,其可被构造成能限制缝钉滑轨组件160的切割构件164和/或任何其他部分的近侧移动。在多种实施例中,壳体170的至少一部分例如可与钉仓主体152一体地形成。在至少一个这种实施例中,当钉仓主体152例如注射成型时,可形成第一侧壁172、第二侧壁174、顶壁176和/或后壁178。在某些实施例中,壳体170的至少一部分可通过扣合装配、压合装配和/或任何其他合适的方式组装至钉仓主体152。
在多种实施例中,除了上文所述,切割构件164可由平坦或至少基本上平坦的主体限定,该主体具有沿着切割构件主体的至少一侧延伸的刀口。在至少一个这种实施例中,第一侧壁172和/或第二侧壁174可被构造和布置成使得它们可包括平坦或至少基本上平坦的内表面173,其与切割构件164的侧面平行或至少基本上平行。在某些实施例中,可在侧壁172和174的内表面173之间贴近地容纳切割构件164。在至少一个这种实施例中,侧壁172和174之间的距离可与狭槽156的宽度相同或至少基本上相同。在任何情况下,壳体可被构造成使得例如壳体的至少一部分延伸到狭槽156的至少一部分上方。在某些实施例中,壳体170可完全包封或包裹切割构件164和/或切割面165。在至少一个实施例中(未作图示),壳体可包括可断开和/或可切割部分,其可至少部分地分离、分隔和/或以其他方式变形,以便允许切割构件退出壳体。在至少一个这种实施例中,组织切割面可被构造成例如与壳体接触以断开和/或切割壳体壁。在多种实施例中,壳体壁可包括薄的部分、厚度减小部分、划痕和/或任何其他构型以便于壳体壁的变形和/或切割。在某些实施例中,切割构件例如可包括一个或多个额外的切割面和/或砧座,其可被构造成使壳体变形和/或切割壳体。在至少一个实施例中,壳体可包括活动的和/或柔韧的部分,例如铰接构件和/或柔韧的翼,其可被构造成充分移动和/或折曲以使切割构件能够通过。在任何情况下,可预想到这样的实施例,其中切割构件可具有切割组织的任何合适构型,并且保护壳体可具有至少部分地包封或包裹切割构件的任何合适构型。此外,虽然切割构件可具有上述尖锐刀刃,但可预想到其他合适的切割构件,例如那些供给足以切开组织的电流的切割构件。
如上所述,壳体170可被构造成当它处于其近侧位置时至少部分地覆盖、包封和/或包裹切割构件。在多种实施例中,切割构件例如可向远侧推进以切割组织,并且随后向近侧退回以便再次将切割构件定位在壳体170内。在此类实施例中,将钉仓组装至外科缝合器械以及从外科缝合器械中取出钉仓时,切割构件可至少部分地被壳体170覆盖。在某些实施例中,新的或未用完的钉仓可插入钉仓通道内以替换至少部分用尽的钉仓。在至少一个这种实施例中,新钉仓可包括设置在其中的新切割构件和/或缝钉滑轨组件,但可预想到这样的实施例,其中之前使用的切割构件和/或缝钉滑轨组件可从用尽的钉仓充分退出并推进至新钉仓以便再次使用。在其中每个新钉仓均设有新切割构件和/或缝钉滑轨组件的实施例中,每个钉仓可使用例如尖锐的刀刃。
在多种实施例中(未作图示),钉仓可包括两个或更多个壳体,其被构造成当钉仓处于两个或更多个位置时至少部分地覆盖切割构件。在至少一个实施例中,钉仓可包括近侧壳体,其被构造成例如当钉仓处于其近侧位置时至少部分地覆盖切割构件,并且此外还包括远侧壳体,其被构造成例如当钉仓处于其远侧位置时至少部分地覆盖切割构件。在至少一个这种实施例中,将钉仓组装至外科缝合器械时切割构件可设置在近侧壳体内,并且在某些实施例中,切割构件在横切了例如定位在端部操纵装置内的组织之后可被推进至远侧壳体内。在此类实施例中,因此,当从外科缝合器中取出钉仓时,切割构件可至少部分地设置在远侧壳体内。当血管例如定位在钉仓的近侧壳体和远侧壳体中间时,此类实施例可能特别有效。在多种实施例中(未作图示),切割构件可从远侧位置向近侧移至近侧位置,和/或任何其他合适的位置。
在多种实施例中,除了上文所述,砧座130可包括一个或多个孔、狭槽或凹陷179(图17),其可被构造成例如当砧座130与钉仓150紧密相对时接纳壳体170的至少一部分。在至少一个实施例中,壳体170和凹陷179之间可存在足够的间隙,使得砧座130和钉仓150可相对于彼此移动,并且两者间没有干涉或至少基本上没有干涉。在上面概述的具有不止一个切割构件壳体的实施例中,相对的砧座可具有不止一个用于接纳壳体的对应孔。在多种实施例中,砧座可包括可动的切割构件和至少一个壳体,用于至少部分地覆盖、包封和/或包裹切割构件。在某些实施例中(未作图示),砧座和钉仓两者均可包括至少一个可动的切割构件和/或至少一个壳体,其被构造成例如当它们位于近侧位置时至少部分地覆盖、包裹或包封切割构件。
如上面所概述,推杆组件200可向远侧推进以便使缝钉滑轨组件160移至钉仓组件150内。在多种实施例中,亦如上文所作概述,缝钉滑轨162的楔状凸轮表面167可移至与缝钉驱动器168上的倾斜表面169接合,以依次或同时驱动钉仓150中的缝钉紧靠砧座130并使缝钉形成任何合适的构型,例如B形构型。在至少一个这种实施例中,参见图17,砧座130可包括一个或多个缝钉成形面,例如缝钉凹腔132,其可被构造成使缝钉变形。在某些实施例中,砧座130还可包括狭槽、沟槽或凹槽133,其可被构造成例如可滑动地接纳缝钉滑轨162、切割构件164和/或推杆202的至少一部分。在至少一个实施例中(未作图示),砧座可包括砧板,其可固定地和/或不可动地设置在限定于砧座内的砧座通道内。在多个其他实施例中,如图18和19所示以及下面更详细描述的,砧座130可包括可动地设置在砧座通道136内的砧板134。在某些实施例中,砧座通道136可包括相对的侧壁137,此外还包括在侧壁137之间延伸的基部138。在至少一个实施例中,砧座130还可包括例如组装至其上的远侧前缘部分139,其中前缘部分139可被构造成例如压合和/或扣合至砧座通道136内,使得前缘部分139可牢固地保持在其中。在某些实施例中,前缘部分139可由软性和/或柔韧材料构成,例如橡胶,并且可具有任何合适形状,其可有助于例如将砧座130插入手术部位内。在一些实施例中,参见图28,前缘部分(例如前缘部分139’)可通过一个或多个紧固件139a’保持在砧座上。类似地,参见图1,钉仓通道和/或钉仓(例如钉仓150)可包括前缘部分,例如前缘部分153,其可有助于例如将钉仓150插入手术部位内。
如上文指出,缝钉可从钉仓调出并靠贴于砧座变形。在多种情况下,砧座130和缝钉滑轨162上的缝钉成形面之间的距离可决定缝钉变形的程度。例如,如果砧座130上的砧座凹腔132和缝钉滑轨162上的顶面135(图10-12)之间的距离相对较大,则与砧座凹腔132和滑座表面135之间的距离相对较小时相比,缝钉所变形的程度会较小。相应地,如果砧座凹腔132和滑座表面135之间的距离相对较小,则与砧座凹腔132和滑座表面135之间的距离相对较大时相比,缝钉所变形的程度会较大。通常,砧座凹腔132和滑座表面135之间的距离称为缝钉的成形高度。有时可在钉仓的顶面即平台和砧座上的缝钉成形面之间测量缝钉的成形高度。然而,就本专利申请而言,任何涉及缝钉成形高度等的内容均可酌情包括一种或两种测量方式和/或任何其他合适的测量方式。在任何情况下,如下文更详细描述,外科缝合器械(例如缝合器械100)可包括用于调整缝钉成形高度的装置。
在多种实施例中,除了上文所述,砧座可包括一个或多个成形面,其可朝向和/或远离钉仓移动,以便设定缝钉的成形高度。在至少一个实施例中,参见图17-23,砧座130可包括砧板134,其可以可移动和/或可滑动地设置在砧座通道136内。在某些实施例中,砧座130还可包括一个或多个保持销或导销140,其中砧板134可包括一个或多个保持槽或导槽141,其被构造成滑动地接纳销140的至少一部分。在至少一个这种实施例中,销140和/或槽141被构造成限定预定路径,砧板134可沿着该预定路径移动。参见图18,销140和槽141被构造和布置成使得砧板134可沿着直线、或至少基本上直线的路径移动,其中直线路径可至少部分地由例如轴线142和143限定。还可预想到其他实施例,其中砧板可沿着非直线路径,例如弯曲和/或曲线路径移动。在某些实施例中,销140的至少一部分可保持在侧壁137的孔144内,其中,在至少一个实施例中,销140可被压配合于孔144内。在任何情况下,如本文所述,销140可随着例如其朝向和/或远离钉仓150移动而引导砧板134。
在多种实施例中,除了上文所述,外科缝合器械(例如缝合器械100)可包括一个或多个调整构件,所述调整构件被构造成定位砧座的一部分(例如砧板134)相对于砧座组件其他部分和/或相对的钉仓的位置。在某些实施例中,参见图18和19,缝合器械100可包括砧板调整构件230,该构件可被构造成能限制砧板134的运动范围。在至少一个这种实施例中,参见图20和21,调整构件230可定位在砧板134中间的第一位置,其中调整构件230的第一表面即台阶231定位在砧座通道136的基部138和砧板134上的第一定位表面145中间。在这样的第一位置,第一台阶231可限定砧板134和砧座通道136之间可能或允许的相对移动量。例如,当如上所述砧座130被对着组织夹紧时,砧板134可接触组织并朝基部138向上滑动,直到第一定位表面145接触第一台阶231。一旦表面145和台阶231接触,调整构件230即可防止或至少阻碍砧板134进一步朝基部138移动。在至少一个这种实施例中,因此,调整构件230可作为止挡,使得基部138和砧板134上的组织接触表面148之间的距离可由第一距离234限定。虽然本例中基部138用作参考基准,但砧座130的其他部分和/或相对的钉仓例如也可用作参考基准。当调整构件230位于其第一位置时,如上所述,调整构件230的第二表面即台阶232可定位在基部138和砧板134上的第二定位表面146中间,此外,第三表面即台阶233可定位在基部138和第三定位表面147中间。参见图20,调整构件230可包括两组或更多组台阶231、232和/或233,并且砧板134可包括两组或更多组定位表面145、146和/或147。虽然第一台阶231和第一定位表面145如上文所述被构造成控制砧板134的位置,但调整构件230的第二和第三台阶(232、233)以及砧板134的第二和第三定位表面(146、147)分别也被构造成控制砧板134的位置。虽然为简洁起见,本例将针对第一表面即台阶231描述控制砧板134位置的表面,但是读者应当理解,台阶232和233也可控制砧板134的位置。
在某些实施例中,调整构件230的第一位置可提供相对较小或较短的缝钉成形高度。在其他实施例中(未作图示),调整构件的第一位置可提供中等、相对较大和/或任何其他合适的缝钉成形高度。在与调整构件第一位置相关的成形高度合适的情况下,外科医生可如上文所述着手用外科缝合器械缝合和/或切割组织。然而,在缝钉成形高度不合适的情况下,外科医生或其他临床医生可移动调整构件230,使得当砧板134接触到设置在砧座130和钉仓150中间的组织时,调整构件230可允许砧板134向上滑动另一段距离。在至少一个这种情况下,允许砧板134向上滑动的距离可以更大,从而提供更大的缝钉成形高度。相应地,在其他情况下,可移动调整构件,使得例如当砧板134接触组织时,砧板134可向上滑动较短的距离,从而提供更短的缝钉成形高度。虽然术语“向上”等可意指垂直向上,但该术语不受这样的限制;相反,“向上”可指例如朝向砧座基部和/或远离钉仓的任何方向。在任何情况下,调整构件230可在其第一位置(如图21所示)和第二位置(如图22所示)之间移动,以便增加缝钉成形高度。如图22中的箭头“P”所指,调整构件230可向近侧滑动,以便使调整构件230在其第一和第二位置之间移动,但可预想到这样的实施例,其中调整构件可向远侧和/或任何其他合适的方向滑动,以便调节调整构件230。一旦调整构件230移动至其第二位置,参见图22,第一表面即台阶231即可定位于基部138和砧板134的第二定位表面146中间。在这样的第二位置,第一台阶231可再次限定砧板134和砧座通道136之间允许的相对移动量。在至少一个实施例中,与上文所述类似,调整构件230可作为止挡,使得基部138和砧板134上的组织接触表面148之间的距离可由第二距离235限定。
除了上文所述,调整构件230可在其第二位置(如图22所示)和第三位置(如图23所示)之间移动,以便再次增加缝钉成形高度。如图23中的箭头“P”所指,调整构件230可向近侧滑动,以在其第二和第三位置之间移动调整构件230。一旦调整构件230移动至其第三位置,参见图23,第一表面即台阶231即可定位于基部138和第三定位表面147中间。在此第三位置中,第一台阶231可再次限定砧板134和砧座通道136之间的相对移动量。在至少一个实施例中,与上文所述类似,调整构件230可作为止挡,使得基部138和砧板134上的组织接触表面148之间的距离可由第三距离236限定。虽然调整构件230可在上述三个位置之间选择性移动以提供三种不同的缝钉成形高度,然而可预想到其他实施例,其包括可在超过三个位置之间移动的调整构件以提供超过三种不同的缝钉成形高度。例如,调整构件可在四个位置之间移动,以便提供四种缝钉成形高度。还可预想到这样一些实施例,其包括可在两个位置之间移动的调整构件以提供两种缝钉成形高度。此外,虽然调整构件230的表面或台阶231、232和233以降序排列,但可预想到其他排列,其中所述表面或台阶以升序排列。可预想到其他排列,其中表面或台阶不必以升序或降序排列。类似地,砧板134的定位表面145、146和147可以按升序、降序(图20)和/或任何其他合适的顺序排列。此外,虽然调整构件230可沿轴线滑动,然而可预想到其他实施例,其中调整构件可沿任何合适的路径,例如弯曲和/或曲线路径移动。
如上文所述,参见图21,调整构件230可包括三个表面或台阶231、232和233,而砧板134可包括三个相应的调整表面145、146和147。当调整构件230位于其第一位置时,例如,第一表面231可被定位成使其靠贴于或邻近第一调整表面145,第二表面232可被定位成使其靠贴于或邻近第二调整表面146,并且第三表面233可被定位成使其靠贴于或邻近第三调整表面147。由于调整构件230相对于砧板134滑动,如上文所述并参见图22和23,调整构件230的表面231、232和233可相对于砧板134的表面145、146和147顺序地换位。在至少一个这种实施例中,调整构件的台阶数可与砧板上的定位表面数相同。还可预想到其他实施例,其中调整构件的台阶多于砧板上的定位表面。在至少一个这种实施例中,例如砧板可包括一个定位表面,其中调整构件的台阶可有选择地用来限制砧板的向上运动。在多种实施例中,总体参见调整构件230和砧板134,砧板可包括一个定位表面,例如定位表面145,其中调整构件230的台阶231、232和233例如可有选择地设置在基部138和定位表面145中间。在此类实施例中,第一台阶231可具有第一厚度或高度,所述第一厚度或高度可阻挡或限制砧板134的向上运动,以便限定第一缝钉成形高度,第二台阶232可具有第二厚度或高度,所述第二厚度或高度可阻挡或限制砧板134的向上运动,以便限定第二缝钉成形高度,此外,第三台阶233可具有第三厚度或高度,所述第三厚度或高度可阻挡或限制砧板134的向上运动,以便限定第三缝钉成形高度。在至少一个实施例中,台阶231、232和/或233的厚度或高度可在调整构件230的后表面237和会接触砧板134的台阶(231、232、233)上的表面之间测量。在多种实施例中,第一台阶231和第二台阶232之间的高度或厚度差值可与第二台阶232和第三台阶233之间的高度或厚度差值相同或至少基本上相同。在至少一个这种实施例中,因此,台阶的高度可以按线性速率或至少基本上线性速率增加。在替代实施例中,第一和第二台阶之间的高度或厚度差值可与第二和第三台阶之间的高度或厚度差值不同。在至少一个这种实施例中,第一、第二和第三台阶的高度或厚度不会以线性速率增加或减少;相反(未作图示),台阶的高度或厚度可以非线性和/或几何速率增加或减少。
如上文所述,调整构件(例如调整构件230)可在两个或更多个位置之间移动。在多种实施例中,外科缝合器械可包括被构造成移动调整构件的致动器。在至少一个实施例中,参见图17-20,外科缝合器械100可包括致动器250,该致动器被可操作地附接于调整构件230,以使力可被施加于致动器250并传递给调整构件230。在某些实施例中,如上文所述,致动器250可包括抓握部即手柄252,所述抓握部即手柄例如可被构造可由外科医生抓握,以便在砧座130内推进或缩回调整构件230。在某些实施例中,抓握部252可从致动器主体251延伸,其中致动器主体251可包括一个或多个孔、槽或腔253,所述孔、槽或腔可被构造成接纳调整构件230的至少一部分。在至少一个这种实施例中,参见图19,调整构件230可包括由其延伸的锁扣254,其中锁扣254的至少一部分可被接纳于孔253内,以便将致动器主体251保持在调整构件230上。在多种实施例中,锁扣254可包括一个或多个弹性或柔性腿255,当插入孔253时,所述腿部可弯曲,但是当弹性腿255的脚256充分推过孔253后,会弹性返回或至少部分地返回到它们的未弯曲位置。在至少一个这种实施例中,脚256可防止或至少阻碍致动器主体251从调整构件230分离。
在多种实施例中,除了上文所述,外科缝合器械100还可包括制动机构,所述制动机构可被构造成将致动器250和/或调整构件230固定就位,或以可脱开的方式固定就位。在至少一个实施例中,参见图19,制动构件260可附接于致动器250,其中在至少一些实施例中,致动器主体251可包括一个或多个沟槽、凹槽或凹陷257,它们可被构造成接纳制动构件260的制动主体261和/或将其保持在其中。在至少一个实施例中,制动主体261可包括一个或多个孔263和/或任何其他合适的沟槽、狭槽或凹槽,它们例如可被构造成接纳一个或多个紧固件,用于将制动主体261固定于致动器251。制动构件260还可包括制动腿262,所述制动腿例如可被构造成接合第一支架部分110中的一个或多个凹陷、孔或凹槽101(图2-7)。更具体地讲,参见图2和3,每个侧面凸缘128可包括一个或多个限定于其中的凹陷101(101a、101b和101c),其中制动腿262可被偏压成与侧面凸缘128的顶面接合,使得制动腿262可滑入和滑出凹陷101。在示出的实施例中,每个侧面凸缘可包括三个凹陷101,所述凹陷可被构造成将致动器250可移动地保持在第一远侧位置、第二中间位置和第三近侧位置,其中致动器250的第一、第二和第三位置可分别对应于上述调整构件230的第一、第二和第三位置。例如,当致动器250位于其第一远侧位置时,制动构件260的制动腿262可定位于凹陷101a中,以便将致动器250和调整构件230可移动地保持在它们的第一位置。当施加足够的力时,致动器250可向近侧移动到其第二位置,使得制动腿162定位于凹陷101b内,并且致动器250和调整构件230保持在它们的第二位置。类似地,当施加足够的力时,致动器250可向近侧移动到其第三位置,使得制动腿162定位于凹陷101c内,并且致动器250和调整构件230保持在它们的第三位置。在多种实施例中,制动腿162可被构造成使得致动器250可返回其第一和/或第二位置。
如上文所述,致动器250可使调整构件230沿着两个或更多个位置之间的预定路径移动。在多种实施例中,外科缝合器械100例如可包括用于控制或限制调整构件230和/或致动器250移动的一个或多个导向装置。在一些实施例中,可在砧座130的侧壁137之间贴近地容纳调整构件230,使得侧壁137可引导调整构件230。在至少一个这种实施例中,侧壁137可被构造成控制或限制调整构件230的侧向或左右移动。在多种实施例中,制动构件160的制动腿162可包括弹性构件,所述弹性构件可被构造成对调整构件230施加向上的偏置力或拉力,从而将调整构件230定位在紧靠或至少邻近基部138和中间侧壁137的位置。在某些实施例中,参见图19,砧座130的基部138还可包括导槽149,所述导槽可被构造成在其中接纳调整构件230和/或致动器250的至少一部分,使得导槽149可限制调整构件230和致动器250的移动。在至少一个这种实施例中,调整构件230的锁扣254可被构造成延伸穿过导槽149,使得当锁扣254插入上述的致动器250的孔253时,可将砧座130的基部138捕获在调整构件230和致动器250中间。在某些实施例中,导槽149可被构造成能限制锁扣254的移动,使得当调整构件230位于其第一即最远侧位置时防止或至少阻碍调整构件230向远侧移动,和/或相似地当调整构件230位于其第三即最近侧位置时防止或至少限制其向近侧移动。
在多种实施例中,除了上文所述,制动构件(类似于例如制动构件260)可用于偏置第一柄部102和第二柄部104,使它们彼此离开。在至少一个实施例中,参见图37,外科缝合器械100’可包括制动构件260’,其被构造成定位第一柄部102和第二柄部104,使得砧座130和钉仓150之间存在间隙。此类结构,如上文所述,可让外科医生能够轻松操纵外科器械,而无需保持第一和第二柄部彼此分开。在某些实施例中,制动构件260’可充分安装到第二柄部104,使得从制动构件260’延伸的制动腿262’可接触凸缘128,并且当被挤压时,将偏置力施加到第一和第二柄部。如图37所示,制动腿262’可接触凸缘128上的表面101d。为了挤压制动腿262’,闩锁机构180可移动到部分关闭位置,使得闩锁臂188可接合并至少部分地包裹闩锁凸起131。在此构造中,外科医生可操纵器械,并且当对位置感到满意时,将闩锁机构180移动到关闭位置,并进一步挤压制动腿262’。与上文所述类似,制动构件260’可与致动器250固定或换句话讲可操作地接合,使得当致动器250在其上述第一、第二和第三位置之间移动时,制动腿262’可分别接合凹陷101a、101b和101c。在至少一个这种实施例中,因此,致动器250可具有预置位置,其中致动器250相对于其第一位置设于远侧,此外,表面101d可包括预置表面,当致动器250位于其预置位置时,制动腿262’可被设置成紧靠所述预置表面。
如上文所述,调整构件可在第一和第二位置之间滑动或平移,以便调整外科缝合器械所调配的缝钉的成形高度。在多种实施例中(未作图示),调整构件例如可被构造成使砧板朝向和/或远离相对的钉仓正向位移。在至少一个这种实施例中,外科缝合器械可包括一个或多个偏置构件,例如弹簧,其被构造成使砧板紧靠调整构件定位,使得当调整构件在其第一和第二位置之间移动时,调整构件可使砧板在第一和第二位置之间位移,以便设定第一和第二缝钉成形高度。在多种实施例中,由以上可得出,调整构件可被构造成将一部分砧座用凸轮使之到位。在至少一个这种实施例中,调整构件可沿轴线滑动,以使砧板正向位移。在其他实施例中,可旋转调整构件例如可被构造成使砧板朝向和/或远离钉仓正向位移。
除了上文所述,如下文更详细描述,调整构件可被转动来调整缝钉成形高度。参见图24-36,与上文所述类似,外科器械100’可包括第一柄部102’、第二柄部104’和闭锁机构180’,所述闭锁机构可用于将组织夹在砧座130’和钉仓150’中间。参见图25,同样与上文所述类似,闭锁机构180’可通过一个或多个枢轴销182’枢转地连接到第一部分102’,其中闭锁机构180’可包括一个或多个闩锁臂188’,所述闩锁臂可被构造成接合第二部分104’,并将第一和第二柄部闩锁在一起。同样与上文所述类似,参见图25和27,外科器械100’还可包括推杆组件200’,所述推杆组件可被构造成在端部操纵装置120’内推进切割构件和/或缝钉滑轨。在至少一个这种实施例中,推杆组件200’可包括近端203’和致动器204’,其中致动器204’可被可旋转地安装在近端203’,并被有选择地设置在缝合器械100’的第一和第二侧面上。在多种实施例中,外科缝合器械100’可具有与结合外科缝合器械100描述的那些特征相同或类似的特征,并且可以按与器械100相同的方式或类似的方式操作,因此这里不再重复这类细节。
在多种实施例中,参见图27,外科器械100’可包括可旋转调整构件230’,所述可旋转调整构件可被有选择地设置在至少第一和第二位置,以便提供不同的缝钉成形高度。在某些实施例中,外科器械100’可包括致动器250’,所述致动器可操作地连接到调整构件230’,使得致动器250’可在至少其第一和第二位置之间移动调整构件230’。在至少一个实施例中,参见图28,致动器250’可包括致动器主体251’和抓握部即手柄252’。致动器主体251’可包括孔258’,所述孔可被构造成接纳调整构件230’的近端238’,使得旋转运动、扭矩和/或力可在致动器250’和调整构件230’之间传递。在至少一个这种实施例中,参见图36,孔258’可具有非圆形轮廓和/或包括一个或多个平坦传动面的轮廓,所述传动面被构造成在致动器主体251’和致动器230’之间传递旋转运动。在某些实施例中,孔258’可被确定尺寸并构造成贴近地容纳致动器230’的近端238’。在至少一个实施例中,孔258’可被构造成以压合和/或扣合装配方式接纳近端238’。在多种实施例中,再次参见图28,柄部104’可包括一个或多个狭槽259’,所述狭槽可被构造成允许致动器主体251’的至少一部分延伸穿过其中,使得抓握部252’可组装到致动器主体251’,其中柄部104’的至少一部分定位于其间。在至少一个这种实施例中,第二柄部104’还可包括凹陷253’,所述凹陷可被构造成使得抓握部252’的至少一部分(如果不是全部)定位于凹陷253’内。在某些实施例中,凹陷253’可被构造成使得抓握部252’不延伸于第二柄部104’的顶面上方,但是在其他实施例中,如图30所示,抓握部252’的上部可延伸到第二柄部104上方,使得外科医生能够轻松地触及抓握部252’。
在多种实施例中,如上文所述,调整构件可在至少第一和第二位置之间转动,以便调整外科缝合器所调配的缝钉的成形高度。在某些实施例中,参见图28,外科缝合器械可包括可旋转地设置在砧座内的调整构件,其中调整构件可被构造成能限制可移动砧座部分的相对移动。在至少一个这种实施例中,外科缝合器械100’可包括砧板134’,所述砧板可通过保持销或导销140’滑动地保持在砧座通道136’内,其中导销140’可被构造成允许砧板134’在其接触组织时向上滑动,如上文所述。参见图27、30和31,调整构件230’可定位于第一位置或取向,使得其可限制砧板134’在砧座通道136’内的向上运动,并规定缝钉的缝钉成形高度。在至少一个这种实施例中,参见图30和31,调整构件230’可包括相互面对的第一表面231’,所述相互面对的第一表面可定位于砧座通道136’的基部138’和砧板134’的定位表面145’中间,使得例如当定位表面145’接触第一表面231’之一时,砧板134’的组织接触表面148’可定位在离砧座130’上的基准面129’第一距离234’的位置。相应地,成形面132’可定位在离钉仓第一距离的位置,使得从钉仓调出缝钉时,缝钉可变形至第一缝钉高度。除了上文所述,第一直径241’可在第一表面231’之间限定,其中第一直径241’可限定砧板134’在砧座通道136’内的最大向上位置。
如上文所指出,调整构件230’可被转动来调整缝钉的成形高度。在多种实施例中,调整构件230’可在其第一位置或取向(图30和31)和第二位置或取向(图32和33)之间转动。在至少一个实施例中,参见图32和33,手柄252’可在箭头“A”指示的方向上转动,以使调整构件230’在其第一和第二位置之间移动。与上文所述类似,当致动器230’位于其第二位置或取向时,致动器230’可限制砧板134’在砧座通道136’内的向上运动,并规定缝钉的缝钉成形高度。在至少一个这种实施例中,参见图32和33,调整构件230’可包括相互面对的第二表面232’,所述相对的第二表面可定位于基部138’和定位表面145’中间,使得例如当定位表面145’接触第二表面232’之一时,砧板134’的组织接触表面148’可定位在离基准面129’第二距离235’的位置。相应地,成形面132’可定位在离钉仓第二距离的位置,使得从钉仓调出缝钉时,缝钉可变形至第二缝钉高度。在多种实施例中,与上文所述类似,第二直径242’可被限定在第二表面232’之间,其中第二直径242’可限定砧板134’在砧座通道136’内的最大向上位置。虽然第一表面231’和第二表面232’通过平坦或至少基本上平坦的表面限定,然而可预想到其他实施例,其中第一表面231’和第二表面232’可包括至少部分弓形或弯曲的轮廓。在任何情况下,参见图27,调整构件230’可包括一个或多个空隙槽240’,所述空隙槽可被构造成提供致动器230’和保持销140’之间的空隙。空隙槽240’可被构造成在致动器230’位于其第一位置、第二位置和/或任何其他合适位置时提供致动器230’和保持销140’之间的空隙。
在多种实施例中,除了上文所述,调整构件230’可在其第一位置或取向(图30和31)和第三位置或取向(图34和35)之间转动。在至少一个实施例中,参见图34和35,手柄252’可在箭头“B”指示的方向上转动,以使调整构件230’在其第一和第三位置之间移动。与上文所述类似,当致动器230’位于其第三位置或取向时,致动器230’可限制砧板134’在砧座通道136’内的向上运动,并规定缝钉的缝钉成形高度。在至少一个这种实施例中,参见图34和35,调整构件230’可包括相互面对的第三表面233’,所述相互面对的第三表面可定位于基部138’和定位表面145’中间,使得例如当定位表面145’接触第三表面233’之一时,砧板134’的组织接触表面148’可定位在离基准面129’第三距离236’的位置。相应地,成形面132’可定位在离钉仓第三距离的位置,使得从钉仓调出缝钉时,缝钉可变形至第三缝钉高度。在多种实施例中,与上文所述类似,第三直径243’可被限定在第三表面233’之间,其中第三直径243’可限定砧板134’在砧座通道136’内的最大向上位置。再次参见图34和35,第三表面233’可由至少部分弓形的轮廓限定,然而可预想到其他实施例,其中第三表面233’可包括平坦或至少基本上平坦的轮廓。在至少一个实施例中,调整构件230’可构造成使得弓形的第三表面233’之间的最大距离或直径可用于限定第三缝钉高度。
如上文所述,参见图30和31,调整构件230’可定位于第一位置或取向,以设定外科缝合器械100’所调配的缝钉的第一成形高度。同样如上文所述,参见图32和33,致动器250’可用于将调整构件230’移动至其第二位置或取向,以设定缝钉的第二成形高度。要做到这一点,在至少一个实施例中,可将力施加到手柄252’,从而引起手柄252’和连接到该处的调整构件230’在箭头“A”指示的方向上转动。在至少一个实施例中,调整构件230’和/或致动器250’可被充分地保持,使得例如当调整构件230’旋转时,调整构件230’能够绕轴线,例如轴线245’(图27)旋转。在至少一个实施例中,参见图25,推杆组件200’的近端203’可包括一个或多个凹槽、沟槽或凹陷205’,所述凹槽、沟槽或凹陷可被构造成在其中接纳和/或保持调整构件230’和/或致动器250’的至少一部分。在任何情况下,如图30-33所示,与调整构件230’位于其第一位置时相比,调整构件230’的第二位置或取向可允许砧板134’在砧座通道136’内滑动更长的距离。在至少一个实施例中,因此,第二缝钉成形高度可大于第一缝钉成形高度。同样如上文所述,参见图34和35,致动器250’可用于将调整构件230’移动至其第三位置或取向,以设定缝钉的第三成形高度。要做到这一点,在至少一个实施例中,可将力施加到手柄252’,从而引起手柄252’和连接到该处的调整构件230’在箭头“B”指示的方向上转动。如图30、31、34和35所示,与调整构件230’位于其第一位置时相比,调整构件230’的第三位置或取向可允许砧板134’在砧座通道136’内滑动更短的距离。在至少一个实施例中,因此,第一和第二缝钉成形高度可大于第三缝钉成形高度。在至少一个这种实施例中,调整构件230’和致动器250’的第一位置可代表中间位置,其中调整构件230’可直接从其第一位置有选择地移动至其第二和第三位置。事实上,调整构件230’的第一位置可代表中间缝钉高度,其中调整构件230’的第二和第三缝钉位置可分别代表更高和更低的缝钉高度。在某些实施例中,参见图24,外科缝合器械100’可包括一个或多个位于其上的标记,所述标记可被构造成呈现缝钉成形高度或至少相对成形高度,这些高度是可选择的。例如,第二柄部104’可包括第一标记245’、第二标记246’和第三标记247’,所述第一标记可指示中间缝钉高度即第一缝钉高度,所述第二标记可指示较高缝钉高度即第二缝钉高度,所述第三标记可指示较低缝钉高度即第三缝钉高度。
在多种实施例中,除了上文所述,第一表面231’、第二表面232’和第三表面233’中的一个或多个可构成或限定、或至少部分地构成或限定调整构件230’的周边或外周。如上文所讨论,由于第一、第二和第三表面(231’、232’和233’)分别限定了第一、第二和第三直径(241’、242’和243’),调整构件230’的周边或外周可以是非圆形的。然而,在某些实施例中,调整构件230’的周边或外周可以是对称的、基本上对称的和/或非对称的。在多种实施例中,除了上文所述,例如调整构件可包括可旋转地设置在砧座130’的基部138’和砧板134’的调整表面145’中间的凸轮。在至少一个这种实施例中,第一表面231’、第二表面232’和第三表面233’中的一个或多个例如可构成或限定凸轮轮廓,与上文所述类似,所述凸轮轮廓可被构造成正向定位砧板134’和/或提供可由砧板134’靠贴而定位的止挡。在任何情况下(未作图示),可预想到多种实施例,其中调整构件可被滑动和转动以设定外科缝合器械所调配的缝钉的两个或更多个缝钉成形高度。在至少一个这种实施例中,调整构件可包括凸轮轮廓,所述凸轮轮廓可沿着调整构件的长度限定,其中纵向和/或旋转运动可用于在至少第一和第二位置之间移动凸轮轮廓。
在多种实施例中,与上文所述类似,外科器械100’还可包括制动机构,所述制动机构被构造成使致动器250’固定到位或至少可释放地固定到位。在至少一个实施例中,参见图25和26,外科器械100’还可包括制动构件260’,所述制动构件包括制动主体261’和一个或多个制动腿262’。参见图26,制动主体261’可包括一个或多个凹槽、凹陷或沟槽263’,所述凹槽、凹陷或沟槽可被构造成在其中接纳第二柄部104’近端105’的至少一部分,使得制动构件260’可保持在适当位置。在至少一个这种实施例中,近端105’还可包括一个或多个凹槽、沟槽或凹陷265’,所述凹槽、沟槽或凹陷可被构造成贴近地容纳制动构件260’。在某些实施例中,制动主体261’的至少一部分(例如沟槽263’)可压合、扣合和/或以其他方式合适地保持于凹陷265’中。同样如图26所示,制动构件260’的每个制动腿262’可包括一个或多个从其延伸的凸起264’,所述凸起可被构造成接合致动器主体251’,并将致动器250’可释放地固定到位。在至少一个实施例中,参见图36,致动器主体251’可包括一个或多个凹陷或小孔269’,所述凹陷或小孔可被构造成接纳凸起264’。凸起例如可被构造成在凸起264’定位于凹陷269’内时将致动器250’保持在其第一位置,直到有足够的力施加于致动器250’上而使凸起264’移出凹陷269’。更具体地讲,施加到致动器250’的力可传递到凸起264’,并且由于凸起264’和凹陷269’之间具有配合表面,与凸起264’联接的制动腿262’可向近侧弯曲或移动,以允许致动器主体251’相对于该处移动。为了适应此近侧移动,参见图25,凹陷265’可包括延长部分266’,所述延长部分可各自被构造成接纳制动腿262’的至少一部分,以使得制动腿262’可相对于柄部104’移动。当致动器250’移动到其第二或第三位置时,致动器主体251’可接触从另一条制动腿262’延伸的凸起264’,并使制动腿262’向近侧弯曲,使得致动器250’一旦位于其第二或第三位置,制动腿262’即可向前或向远侧回弹,使凸起264’可固定于凹陷269’内。在至少一个实施例中,除了上文所述,凸起264’和凹陷269’侧壁之间的相互作用使得致动器250’可被牢固地保持在例如其第一、第二和第三位置之一上,但在施加足够的力时允许致动器250’移动。在此类实施例中,制动构件260’可防止或至少阻碍致动器250’以及相应地调整构件230’被意外地移位。
如上文所讨论,并且如图2所示,第一柄部102的每个侧面凸缘128可包括例如凹口或凹陷127,所述凹口或凹陷可被构造成接纳例如从砧座130和/或第二柄部104的任何其他合适的部分延伸的一个或多个闩锁凸起131。同样如上文所讨论,主要参见图2和3,第一柄部102还可包括可旋转地安装于其上的闭锁机构180,所述闭锁机构可用于接合从第二柄部104延伸的闩锁凸起131并将第一柄部102和第二柄部104固定在一起。闭锁机构180可包括从中延伸的一个或多个闩锁臂188,所述闩锁臂可被构造成接合闩锁凸起131,并且将凸起131拉引和/或固定于凹陷127内,如图7所示。参见图6,至少一个闩锁臂188可包括远端钩189,所述远端钩可被构造成环绕凸起131的至少一部分,从而包围或包裹、或至少部分地包围或包裹凸起131。在至少一个实施例中,闩锁臂188可充当偏心闩锁以使闭锁机构180保持在其锁闭或关闭位置。
在多种实施例中,现在参见图38,每个凸起131可包括定位于凸起131的侧壁191和扩大末端或头部192中间的狭槽或凹槽190,其中狭槽190可被构造成接纳闩锁臂188的至少一部分。更具体地讲,在至少一个实施例中,狭槽190的宽度可大于闩锁臂188的宽度,使得当闩锁臂188与凸起131接合时,闩锁臂188可进入狭槽190。在一些情况下,每个狭槽190的宽度可略大于闩锁臂188的宽度,使得闩锁臂贴近地容纳于狭槽190内。在多种情况下,凸起131的狭槽190、侧壁191和头部192被尺寸确定成并构造成可防止或至少限制相对的侧向移动,即远离或朝向砧座130侧面在闩锁臂188和凸起131之间的移动。然而,除了上文所述,当闩锁臂188将凸起131移动到第一部分102的凹陷127内时,闩锁臂188可在凹槽190内纵向滑动。由于闩锁臂188和凸起131之间存在这样的相对滑动,在这二者之间会产生摩擦力,所述摩擦力可阻止闩锁臂188移动。在多种情况下,当闩锁臂188和凹槽190侧壁之间法向即垂直接触力很大时,此类摩擦力会很大。因此,在很多情况下,外科器械操作者在启动夹紧机构180时必须克服这些摩擦力。
在多个可供选择的实施例中,现在参见图39和40,外科器械可包括一个或多个具有可旋转轴承的闩锁凸起,所述轴承可减少闭锁机构的闩锁臂和闩锁凸起之间的摩擦力大小。在至少一个实施例中,砧座330在很多方面可基本上类似于砧座130,可包括从其每个侧面延伸的闩锁凸起331,其中每个闩锁凸起331可包括可旋转轴承393。在使用中,闭锁机构180的闩锁臂188例如可接触可旋转轴承393,以便将闩锁凸起331定位于凹陷127内。在多种情况下,闩锁臂188可在轴承393的整个表面即外径上滑动;然而,由于轴承393可相对于闩锁臂188旋转,闩锁臂188和凸起331之间摩擦力可小于闩锁臂188和凸起131之间摩擦力。由于存在这样的较小摩擦力,例如夹紧机构180的启动只需要较小的闭合或夹紧力。
在多种实施例中,主要参见图41,每个可旋转轴承393可包括环状或圆形外径394,此外还包括从其延伸的环状或圆形轴承孔395。在某些实施例中,每个凸起331还可包括从侧壁391延伸的轴部396,以及从轴部396延伸的增大的末端或头部392,其中,如图31所示,轴部396可延伸通过可旋转轴承393的轴承孔395。在多种实施例中,轴部396可包括环状或圆形外径,从而可贴近地容纳于轴承孔395内,使得其间的相对径向运动(如果有的话)很小。然而,轴承孔395的直径可足够大于轴部396的外径,使得轴承393可相对于轴部396绕轴线399旋转。在多种实施例中,可旋转轴承393可通过增大的头部392保持在轴部396上。更具体地讲,在至少一个实施例中,增大的头部392可大于或限定的直径大于轴承孔395的直径,使可旋转轴承393不能滑出轴部396的末端。在某些实施例中,侧壁391和头部392可限定其间的间隙距离,此外,轴承393可具有宽度,其中间隙距离可大于轴承393的宽度。在至少一个实施例中,间隙距离可略大于轴承393的宽度,使得轴承393不会或至少基本上不会相对于例如轴线399倾斜。
如上文所讨论,闭锁机构180的闩锁臂188可被构造成接合轴承393,并将轴承393定位于凹陷127内。在多个可供选择的实施例中,主要参见图40,外科器械可包括闭锁机构380,所述闭锁机构可包括在砧座331和钉仓通道324的相对的侧面上从其延伸的第一和第二闩锁臂388。在使用中,与上文所述类似,闩锁臂388可接触轴承393,以将轴承393移入钉仓通道324中的凹陷327内,并且将砧座331朝向钉仓通道324移动。此类移动在图41中用假想线示出。在多种实施例中,每个闩锁臂388可至少部分地限定其中的凹槽或狭槽397,其中每个狭槽397可被构造成接纳轴承393。在至少一个实施例中,狭槽397可包括第一传动面即侧壁398a,所述第一传动面即侧壁可紧靠轴承393定位,并且当闭合力施加到闭锁机构380上时,闩锁臂388可将闭合力施加到轴承393。在此类情况下,当闭锁机构380旋转到其关闭位置时,轴承393可被进一步移入狭槽397。在多种情况下,狭槽397还可包括第二传动面即侧壁398b,所述第二传动面即侧壁可紧靠轴承393的另一侧和/或相对侧定位,使得开启力可通过闩锁臂388施加到轴承393。当闭锁机构380被移入其打开位置时,轴承393可移出狭槽397。在任何情况下,第一传动面398a和第二传动面398b可限定其间的狭槽宽度,所述狭槽宽度可大于轴承393的外径,使得轴承393可在狭槽397内移动。在一些实施例中,狭槽宽度可略大于轴承393的外径。在至少一个实施例中,第一传动面398a和第二传动面398b的至少一些部分可以是彼此平行的、或至少基本上平行的。在至少一个这种实施例中,第一传动面398a的至少一些部分可定位在与第二传动面398b相对的位置。
如上文所述,外科缝合器械可被构造成使一个或多个手术缝钉在第一未调配构型和第二已调配构型之间变形。在多种实施例中,现在参见图39,手术缝钉(例如缝钉400)可包括基部402、从基部402延伸的第一钉腿即可变形部分404,此外还包括从基部402延伸的第二钉腿即可变形部分406。在某些实施例中,基部402、第一钉腿404和第二钉腿406可由连续线材构成,其中在至少一个实施例中,在缝钉400插入外科缝合器并在外科缝合器作用下变形之前,第一钉腿404和第二钉腿406均可以在与基部402垂直的方向上弯曲。更具体地讲,缝钉400可制造成使得基部402沿基线401取向,并且使得钉腿404和406分别沿线409和411取向,所述线与基线401垂直、或至少基本上垂直。在多种实施例中,第一钉腿404可定位于基部402的第一末端,并且第二末端406可定位于基部402的第二末端,其中,在至少一个实施例中,可限定中线403,所述中线延伸通过基部402的中点,并且在与基线401垂直的方向上延伸。当缝钉400处于其第一即未调配构型时,缝钉400可被构造成使得基部402、第一钉腿404和第二钉腿406位于、或至少基本上位于相同或共同平面上。在此类实施例中,基线401以及垂直线409和411可位于相同的平面,其中基部402沿基线401取向,钉腿404和406沿垂直线409和411取向。
在多种实施例中,除了上文所述,构成基部402、第一钉腿404和第二钉腿406的连续线材可由例如钛和/或不锈钢构成。在至少一个实施例中,第一钉腿404可包括第一末端405,并且第二钉腿406可包括第二末端407,其中末端405和407均可包括尖锐或凿形顶端,所述顶端可被构造成刺穿骨头和/或组织。在使用中,缝钉400可在外科缝合器作用下变形,以将例如组织捕获在缝钉400内。在多种实施例中,缝钉400可从钉仓调出,使得钉腿404的末端405和钉腿406的末端407分别接触面对缝钉400定位的砧座。在此类情况下,第一挤压力F 1可施加到第一钉腿404,并且第二挤压力F2可施加到第二钉腿406,而基部402由钉仓的至少一部分支持。如下面更详细地描述,砧座可包括缝钉凹腔,所述缝钉凹腔可将第一挤压力F1施加到第一钉腿404,使得钉腿404的末端405向基部402移动。类似地,缝钉凹腔可将第二挤压力F2施加到第二钉腿406,使得钉腿404的末端407也向基部402移动。除上述之外,下面还将更详细地讨论,现在参见图50-52,缝钉凹腔可将第一钉腿404弯曲到基部402的第一侧,并且将第二钉腿406弯曲到基部402的第二即相对侧。
在多种实施例中,参见图49和50,缝钉400的第一钉腿404可被弯曲以使第一钉腿404受到第一挤压力F1变形时,第一钉腿404的末端405向基部402和第二钉腿406移动。在至少一个实施例中,末端405可从中线403的第一侧410(如图49所示)移动到中线403的第二侧412(如图50所示)。类似地,缝钉400的第二钉腿406可被弯曲以使第二钉腿406受到第二挤压力F2变形时,第二钉腿406的末端407向基部402和第一钉腿404移动。在至少一个实施例中,末端407可从中线403的第二侧412(如图49所示)移动到中线403的第一侧410(如图50所示)。在缝钉400的已调配即变形构型中,如图50所示,钉腿404的末端405和钉腿406的末端407可以它们之间成一角度的方式延伸过中线403。更具体地讲,当处于变形构型时,第一钉腿404的末端405可沿着或关于第一轴线414延伸,并且类似地当处于变形构型时,第二钉腿406的末端407可沿着或关于第二轴线416延伸,使得第一轴线414和第二轴线416限定两者间的角度417。在一些实施例中,角度417可以为例如大约90度。在某些实施例中,角度417的范围可在例如大约0.1度和大约89度之间。在多种实施例中,角度417可大于90度,而在至少一个实施例中,角度417例如可大于大约90度但小于180度。
在多种实施例中,除了上文所述,第一轴线414和第二轴线416在多种实施例中可相对于彼此以横向角取向或交叉,即至少在缝钉400被从图50的侧面或正视视角观看时。更具体地讲,在查看图52时显见,虽然从侧面观察时轴线414和416在横向上延伸(图50),但是在至少一个实施例中,轴线414和416实际上并不彼此相交。在此类实施例中,例如当从顶部或底部观察缝钉400时(图52),轴线414和416可在平行的或至少基本上平行的方向上延伸。此外,在多种实施例中,读者会注意到,第一轴线414和第二轴线416不与基线401垂直。换句话讲,第一钉腿404的末端405和第二钉腿406的末端407不向下直指基部402和基线401。在至少一个这种实施例中,第一轴线414和第二轴线416例如可以各自相对于基线401成锐角延伸。
如上文所述,外科器械可被构造成使图49的缝钉400例如在未变形形状(图49)和变形形状(图50)之间变形。在多种实施例中,同样如上文所述,外科器械可包括具有缝钉凹腔的砧座,所述缝钉凹腔被构造成接纳缝钉的至少一部分并使之变形。在某些实施例中,现在参见图42,砧座可包括组织接触表面501和多个在其中形成的缝钉凹腔500,其中每个缝钉凹腔500可被构造成使缝钉400变形。在多种实施例中,每个缝钉凹腔500可包括纵向轴线599(图43),此外还包括相对于纵向轴线599定位的第一成形杯502和第二成形杯504。在使用中,第一成形杯502可被构造成接纳缝钉400的第一钉腿404,并且第二成形杯504可被构造成接纳第二钉腿406。更具体地讲,在至少一个实施例中,缝钉凹腔500可相对于缝钉400定位,使得例如当缝钉400从钉仓顶出时,第一钉腿404的末端405可进入第一成形杯502,并且第二钉腿406的末端407可进入第二成形杯504。除了上文所述,第一钉腿404的末端405可接触第一成形杯502的基部506,使得第一挤压力F1可施加到第一钉腿404,并且类似地第二钉腿406的末端407可接触第二成形杯504的基部508,使得第二挤压力F2可施加到第二钉腿406。
在多种实施例中,除了上文所述,第一成形杯502可包括内侧部分510和外侧部分512,其中,当第一钉腿404的末端405进入第一成形杯502时,末端405可进入外侧部分512。在进入成形杯502的外侧部分512时,末端405可接触基部506,并且由于基部506具有凹型曲面,末端405可向内导引至内侧部分510。更具体地讲,现在参见图46-48,基部506可朝向组织接触表面501弯曲,使得当钉腿404接触基部506时,末端405可被向下导引,即远离组织接触表面501导向,并向内沿弯曲凹面朝拐折点595导向。在多种实施例中,拐折点595可代表这样的点,基部506的凹面在该点处将开始使第一钉腿404的末端405朝向组织接触表面501向上弯折。在多种实施例中,凹面沿其长度在纵向上的曲率半径r可为恒定的或至少基本上恒定的,如图47和48所示。在某些实施例中,基部506的凹面在第一内侧壁516和第一外侧壁517之间的整个基部506的宽度上的曲率半径r可为恒定的。在任何情况下,当第一钉腿404的末端405推进成形杯502的内侧部分510时,末端405可接触到设置在基部506和第一内侧壁516中间的半径过渡段514。在此类实施例中,半径过渡段514可被构造成引导末端405靠在第一内侧壁516上。
如图43所示,除了上文所述,第一内侧壁516可以相对于缝钉凹腔纵向轴线599成一角度取向。在某些实施例中,第一内侧壁516可以相对于纵向轴线599成锐角(例如10度)取向。在多种实施例中,第一内侧壁516和纵向轴线599可以彼此既不垂直也不平行。在任何情况下,第一内侧壁516可延伸通过轴线599,使得第一内侧壁516的第一部分定位于轴线599的第一侧515上,并且第一内侧壁516的第二部分定位于轴线599的第二侧517上。在多种实施例中,因此,第一内侧壁516可在第一外侧部分512和第一内侧部分510之间延伸。当第一钉腿404的末端405接触第一内侧壁516时,如上文所述,末端405可沿第一内侧壁516并远离纵向轴线599导向,使得钉腿404远离缝钉400的共同平面朝向轴线599的第一侧515弯曲。当第一钉腿404的末端405沿第一内侧壁516导向或被第一内侧壁516弯曲时,如上文所述,钉腿404也可通过基部506导向或弯曲。换句话讲,第一侧壁516和第一基部506可配合使第一钉腿404变形,使得末端405朝基部402并且同时向基部402的第一侧改变方向,如上文所述。在第一钉腿404插入第一成形杯502过程的某个时间点,第一钉腿404的末端405可露出第一成形杯502的第一内侧部分510,并且当钉腿404被缝钉凹腔500进一步变形时,末端405可沿第一轴线414导向(图50),如上文所述。
在多种实施例中,除了上文所述,第一内侧壁516可沿第一基部506的内侧延伸,其中,在至少一个实施例中,第一成形杯502还可包括沿第一基部506的相对侧延伸的第一外侧壁517。在某些实施例中,与上文所述类似,第一成形杯502还可包括定位在基部506与外侧壁517之间的过渡半径519。在至少一个实施例中,现在参见图43,外侧壁517可沿平行于或至少基本上平行于缝钉凹腔纵向轴线599的方向延伸。同样如图43所示,第一内侧壁516和第一外侧壁517可在彼此横断的方向上延伸。在至少一个实施例中,内侧壁516可以例如相对于外侧壁517成锐角(例如大约15度)延伸。在多种实施例中,因此,第一成形杯502的外侧部分512可比内侧部分510更宽。在至少一个这种实施例中,外侧部分512和内侧部分510的宽度可在第一宽度和第二宽度之间逐渐变小。
在多种实施例中,再次参见图43,第一成形杯502的外侧部分512可包括第一外侧壁513,所述第一外侧壁可沿垂直于第一外壁517和/或纵向轴线599的方向延伸并且可限定成形杯502的最外部分。在至少一个实施例中,除了上文所述,第一外侧壁513的宽度可使得外侧部分512可捕获第一钉腿404的末端405并将其导引进杯502的内侧部分510中,如上所述。在至少一个这种实施例中,第一外侧壁513的宽度可至少为第一钉腿404的直径的两倍。在某些实施例中,第一成形杯502还可包括围绕第一内部510和第一外部512的导引面528,所述第一外部512可构造成可将钉腿404导引进和/或导引出成形杯502。在多种实施例中,内侧部分510还可包括内侧壁511,其可限定成形杯502的最内部分。与上文所述类似,内侧壁511还可限定成形杯502的最窄部分。在至少一个实施例中,内侧壁511的宽度可与第一钉腿404的直径相同或至少基本上相同,使得内侧壁511可控制末端405从缝钉成形杯502露出的位置。
在多种实施例中,除了上文所述,第二成形杯504可包括内侧部分520和外侧部分522,其中,当第二钉腿406的末端407进入第二成形杯504时,末端407可进入外侧部分522。在进入成形杯504的外侧部分522后,末端407可接触基部508,并且由于基部508具有凹型曲面,末端407可被朝内侧部分520向内导引。更具体地讲,与上文所述类似,基部508可朝向组织接触表面501弯曲,使得当钉腿406接触基部508时,末端407可被向下导引,即远离组织接触表面501导向,并向内沿弯曲凹面朝拐折点596导向。在多种实施例中,拐折点596可代表这样的点,基部508的凹面在该点处能够开始使第二钉腿406的末端407朝向组织接触表面501向上弯折。在多种实施例中,凹面沿其长度在纵向上的曲率半径r可为恒定的或至少基本上恒定的,这与图47和48所示的第一成形杯502的基部506类似。在任何情况下,当第二钉腿406的末端407行进到成形杯504的内侧部分520中时,末端407都可与定位在基部508和第二内侧壁526之间的半径过渡段524接触。在此类实施例中,半径过渡段524可构造成可将末端407靠着第二内侧壁526导引。
如图43所示,除了上文所述,第二内侧壁526可相对于缝钉凹腔纵向轴线599成一角度取向。在某些实施例中,第二内侧壁526可例如相对于纵向轴线599成锐角(例如10度)取向。在多种实施例中,第二内侧壁526与纵向轴线599彼此可以既不垂直也不平行。在任何情况下,第二内侧壁526可延伸穿过轴线599,使得第二内侧壁526的第一部分定位在轴线599的第一侧515,并且第二内侧壁526的第二部分定位在轴线599的第二侧517。在多种实施例中,因此,第二内侧壁526可在第二外侧部分522和第二内侧部分520之间延伸。当第二钉腿406的末端407以如上所述方式接触内侧壁526时,末端407可被沿内侧壁526导引,使得钉腿406远离缝钉400的共同平面弯向轴线599的第二侧517。当第二钉腿406的末端407以如上所述方式沿内侧壁526导引并被内侧壁526弯曲时,钉腿406还可被基部508导引和弯曲。换句话讲,第二内侧壁526和第二基部508可配合使第二钉腿406变形,使得末端407朝基部402改变方向并同时朝基部402的第二侧即相对侧改变方向,如上所述。在第二钉腿406插入第二成形杯504过程的某个时间点,第二钉腿406的末端407可露出第二成形杯504的第二内侧部分520,并且当钉腿406被缝钉凹腔500进一步变形时,末端407可沿第二轴线416(图50)导引,如上所述。
在多种实施例中,除了上文所述,第二内侧壁526可沿第二基部508的内侧延伸,其中,在至少一个实施例中,第二成形杯504还可包括沿第二基部508的相对侧延伸的第二外侧壁527。在某些实施例中,与上文所述类似,第二成形杯504还可包括定位在基部508与外侧壁527之间的过渡半径529。在至少一个实施例中,现在参见图43,外侧壁527可沿平行于或至少基本上平行于缝钉凹腔纵向轴线599的方向延伸。同样如图43所示,第二内侧壁526和第二外侧壁527可在彼此横断的方向上延伸。在至少一个实施例中,内侧壁526可以例如相对于外侧壁527成锐角(例如大约15度)延伸。在多种实施例中,因此,第二成形杯504的外侧部分522要比内侧部分520更宽。在至少一个这种实施例中,外侧部分522和内侧部分520的宽度可在第一宽度和第二宽度之间逐渐变小。
在多种实施例中,再次参见图43,第二成形杯504的外侧部分522可包括第二外侧壁523,所述第二外侧壁可沿垂直于第二外壁527和/或纵向轴线599的方向延伸并且可限定成形杯504的最外部分。在至少一个实施例中,除了上文所述,第二外侧壁523的宽度可使得外侧部分522可捕获第二钉腿406的末端407并将其导引进杯504的内侧部分520,如上所述。在至少一个这种实施例中,第二外侧壁523的宽度可至少为第二钉腿406的直径的两倍。在某些实施例中,第二成形杯504还可包括围绕第二内部520和第二外部522的导引面529,所述第二外部522可构造成可将钉腿406导引进和/或导引出成形杯504。在多种实施例中,内侧部分520还可包括内侧壁521,其可限定成形杯504的最内部分。与上文所述类似,内侧壁521还可限定成形杯504的最窄部分。在至少一个实施例中,内侧壁521的宽度可与第二钉腿406的直径相同或至少基本上相同,使得内侧壁521可控制末端407从缝钉成形杯504露出的位置。
如上所述,再次参见图43-45,第一成形杯502可包括第一内侧壁516并且第二成形杯504可包括第二内侧壁526。如图43所示,成形杯502的第一内侧部分510可定位在与成形杯504的第二内侧部分520紧密接近或紧密相关的位置,使得第一内侧壁516可定位在邻近第二内侧壁526的位置。在至少一个实施例中,第一内部510或其至少大部分可在第一方向515上偏离缝钉凹腔纵向轴线599,同时第二内部520或其至少大部分可在第二方向517上偏离纵向轴线599。在多种实施例中,缝钉凹腔500可包括设置在第一内侧部分510和第二内侧部分520之间的壁530,其中壁530的第一侧面可构成第一内侧壁516,并且其中壁530的第二侧面可构成第二内侧壁526。在至少一个这种实施例中,第一内侧壁516可平行于或至少基本上平行于第二内侧壁526。更具体地讲,在至少一个实施例中,第一内侧壁516可限定第一平面,并且第二内侧壁526可限定第二平面,其中第一平面与第二平面彼此平行或至少基本上平行。在多种实施例中,再次参见图44和45,第一内侧壁516可垂直于或至少基本上垂直于组织接触表面501,并且类似地第二内侧壁526可垂直于或至少基本上垂直于组织接触表面501。
在多种实施例中,除了上文所述,第一内侧壁516可包括第一垂直部分516a,所述第一垂直部分垂直于或至少基本上垂直于组织接触表面501。在至少一个实施例中,第一垂直部分516a可延伸穿过或横切纵向轴线599。在多种实施例中,第一垂直部分516a可沿第一内侧壁516的整体或仅一部分延伸。类似地,第二内侧壁526可包括第二垂直部分526a,所述第二垂直部分垂直于或至少基本上垂直于组织接触表面501。在至少一个实施例中,此类第二垂直部分526a可延伸穿过或横切纵向轴线599。在多种实施例中,第二垂直部分526a可沿第二内侧壁526的整体或仅一部分延伸。在调配缝钉400过程中,除了上文所述,在第二钉腿406的末端407接触第二内侧壁526的第二垂直部分526a的同时,第一钉腿404的末端405可接触第一内侧壁516的第一垂直部分516a。在此类情况下,第一垂直部分516a和第二垂直部分526a可构成垂直夹钉部。更具体地讲,当钉腿404和406分别接触成形杯502和504的内侧壁516和526时,垂直部分516a和526a可沿相对的方向(即在朝共同平面两侧的方向,如上所述)相配合而控制、弯折和弯曲钉腿404和406。例如,再次参见图52,第一垂直部分516a可构造成可将钉腿404弯折和弯曲到基部402的第一侧,并且第二垂直部分526a可构造成可将钉腿406弯折和弯曲到基部402的第二侧即相对侧。
在多种实施例中,除了上文所述,包括垂直部分516a和526a的垂直夹钉部可沿第一内侧壁516和第二内侧壁526的全长延伸,而在其他实施例中,垂直夹钉部可仅沿侧壁516和526的一部分延伸。在至少一个实施例中,垂直夹钉部可为约0.05英寸长,即第一垂直表面516a与第二垂直表面526a沿内表面516和526长度方向的重叠区可为例如约0.05英寸。在多种实施例中,垂直夹钉部的长度可在例如约0.03英寸和约0.10英寸之间。在某些实施例中,垂直夹钉部的长度可为例如基部506的弯曲凹面的曲率半径(r)的约两倍。在多种实施例中,垂直夹钉部的长度可例如约等于基部506的曲率半径(r)。在至少一个实施例中,垂直夹钉部的长度可在例如约0.5*r和约2*r之间。在多种实施例中,除了上文所述,垂直夹钉部可延伸穿过缝钉凹腔500的纵向轴线599,使得在至少一个实施例中,垂直夹钉部的至少一部分可定位在轴线599的第一侧和/或第二侧。在某些实施例中,垂直夹钉部可延伸穿过第一成形杯502和第二成形杯504的中心部分。
在多种实施例中,第一内侧壁516还可包括第一倾斜部分,其在至少一个实施例中可相对于组织接触表面501成锐角取向。在至少一个这种实施例中,第一倾斜部分可相对于第一垂直部分516a朝外设置。在某些实施例中,第一内侧壁516可包括朝向外侧部分512设置的倾斜部分,所述外侧部分朝第一成形杯502的内侧部分510逐渐变得更垂直,直到倾斜部分过渡到第一垂直部分516a。在多种实施例中,第二内侧壁526还可包括第二倾斜部分,其在至少一个实施例中可相对于组织接触表面501成锐角取向。在至少一个这种实施例中,第二倾斜部分可相对于第二垂直部分526a朝外设置。在某些实施例中,第二内侧壁526可包括朝向外侧部分522设置的倾斜部分,所述外侧部分朝第二成形杯504的内侧部分520逐渐变得更垂直,直到倾斜部分过渡到第二垂直部分526a。
在多种实施例中,现在参见图52A,缝钉凹腔500可构造成使第一钉腿404变形,使得第一末端405偏离基线401第一距离X1。类似地,第二钉腿406可变形成使得第二末端407偏离基线401第二距离X2。在某些实施例中,距离X1和距离X2可相同或至少基本上相同。在多个其他实施例中,距离X1和X2可不同。在至少一个这种实施例中,第一钉腿404可变形成使得例如第一末端405定位在比第二末端407更邻近基部402的位置。在此类实施例中,变形的钉腿404的第一轴线414和变形的钉腿406的第二轴线416可以不平行。更具体地讲,在至少一个实施例中,第一轴线414可相对于基线401成第一角度延伸,并且第二轴线416可相对于基线401成第二角度延伸,其中第二角度不同于第一角度。在多种实施例中,第一钉腿404和第二钉腿406可以不同角度延伸过中线403。在某些其他实施例中,第一钉腿404和第二钉腿406可相对于基线401成不同角度延伸,但钉腿404和406中的一者或两者可以不延伸过中线403。
在多种实施例中,除了上文所述,外科缝合器可包括缝钉凹腔,所述缝钉凹腔可构造成使缝钉400的一个钉腿变形,使得其与基部402位于或基本上位于共同平面,此外还使缝钉400的另一个钉腿朝基部402的一侧变形,如上所述。在至少一个实施例中,第一钉腿404可变形成使得其在与基部402共面或至少基本上共面的方向上延伸过中线403,此外,第二钉腿406可变形成使得其在横切于该平面的方向上延伸过中线403。换句话讲,在至少一个实施例中,缝钉400的轴线414和基线401可彼此共面或至少近似共面,而第二轴线416可在穿过该平面的方向上延伸。在某些实施例中,第一钉腿404和第二钉腿406中至少一者可以不延伸过中线403。
在多种实施例中,除了上文所述,缝钉凹腔500可构造成同时或至少基本上同时使缝钉400的钉腿404和406变形。在至少一个实施例中,在第二成形杯504的基部508接触第二钉腿406的末端407的同时或基本上同时,第一成形杯502的基部506可接触第一钉腿404的末端405。在某些其他实施例中,缝钉凹腔可构造成使钉腿404和406依次变形。在至少一个这种实施例中,例如可先使第一成形杯接触第一钉腿404,再使第二成形杯接触第二钉腿406。在多个可供选择的实施例中(未作图示),手术缝钉可包括超过两个钉腿,例如三个钉腿或四个钉腿,并且缝钉凹腔可包括用于使钉腿变形的相应数量的缝钉成形杯。
在多种实施例中,除了上文所述,由线材构成的手术缝钉400可具有圆形或至少基本上圆形的截面。在多个其他实施例中,现在参见图53-56,手术缝钉(例如缝钉600)例如可以具有非圆形截面。在至少一个实施例中,缝钉600可以包括基部602、第一钉腿604和第二钉腿606,其中基部602及钉腿604和606可由连续线材构成。在多种实施例中,连续线材可具有例如矩形截面。在至少一个实施例中,参见图56,矩形截面可包括底(b)和高(h),其中可相对于中心横向轴线(x)限定底(b),并且其中可相对于中心纵向轴线(y)限定高(h)。在多种情况下,矩形截面可被限定为具有两个惯性矩,即相对于轴线(x)限定的第一惯性矩(Ix)和相对于轴线(y)限定的第二惯性矩(Iy)。在至少一种情况下,第一惯性矩(Ix)可按(b*h^3)/12计算,而第二惯性矩(Iy)可按(h*b^3)/12计算。虽然缝钉600具有矩形或至少基本上矩形的截面,但也可使用任何其他合适的非圆形截面,例如扁圆形、椭圆形和/或梯形截面。
如图56所示,手术缝钉600的底(b)大于高(h),鉴于以上情况,矩形截面的惯性矩(Iy)大于惯性矩(Ix)。在多种实施例中,因此,矩形截面的惯性矩比即Iy/Ix可大于1.0。在某些实施例中,惯性矩比可在例如约2.0和约2.7之间。在某些其他实施例中,惯性矩比可在例如约1.1和约3.0之间。由以上可得出,当在钉腿604上施加力(例如压力载荷F1)时,钉腿604更可能绕轴线(x)弯曲,而不是绕轴线(y)弯曲。在任何情况下,不考虑所有其他因素,钉腿604在此类实施例中更可能在由处于未变形状态时的缝钉600限定的共同平面内弯曲,而不是弯向缝钉基部602的一侧。然而,在多种实施例中,可使用包括砧座和根据本文所述实施例的缝钉凹腔(例如缝钉凹腔500)的外科缝合器,使缝钉600的钉腿604和606在变形时弯离其共同平面。在此类实施例中,尽管事实上抵抗此类扭曲的惯性矩Iy大于惯性矩Ix,但还是会发生这种横向偏转。如图55所示,缝钉600的第一钉腿604可变形成使得其相对于其截面的轴线(x)和轴线(y)弯曲,因此,第一钉腿604可扭曲或变形成使得第一钉腿604的末端605定位在基部602的第一侧。类似地,第二钉腿606可变形成使得其相对于其截面的轴线(x)和轴线(y)弯曲,因此,第二钉腿606可扭曲或变形成使得第二钉腿606的末端607定位在基部602的第二侧。
在多种实施例中,现在参见图57,手术缝钉(例如手术缝钉700)可包括基部702,此外还包括从基部702延伸的第一钉腿704和第二钉腿706。在某些实施例中,与上文所述类似,当缝钉700为未变形或未调配构型(即,被例如外科缝合器的砧座变形前的构形)时,基部702、第一钉腿704和第二钉腿706可位于或至少基本上位于共同平面内。在缝钉700的已变形或已调配构型中,如图57所示,第一钉腿704可变形成使得末端705指向基部702和第二钉腿706。更具体地讲,在至少一个实施例中,末端705可处于沿第一轴线714或关于第一轴线714的方向,第一轴线714相对于中线703成一角度取向。类似地,第二钉腿706可变形成使得末端707指向基部702和第一钉腿704。更具体地讲,在至少一个实施例中,末端707可处于沿第二轴线716或关于第二轴线716的方向,第二轴线716相对于中线703成一角度取向。在多种实施例中,钉腿704的末端705和钉腿706的末端707可以不越过中线703。在某些实施例中,与上文所述类似,第一钉腿704的末端705可变形成使得其延伸到基部702的第一侧,并且第二钉腿706的末端707可变形成使得其延伸到基部702的第二侧即相对侧,从而例如构造发生变形的钉腿704和706并不完全与基部702共面。
在多种实施例中,手术缝钉例如缝钉800(图58)可包括基部802、第一钉腿804和第二钉腿806,其中缝钉800在处于未变形或未调配构型时可包括基本上U形的构型。在至少一个这种实施例中,钉腿804和806可相对于基部802沿垂直或至少基本上垂直的方向延伸。在多种情况下,缝钉800可变形成如图58所示的B形构型。在至少一个这种实施例中,第一钉腿804可朝基部802向下弯曲,使得延伸穿过末端805的轴线814垂直于或至少基本上垂直于基线801。类似地,第二钉腿806可朝基部802向下弯曲,使得延伸穿过末端807的轴线816垂直于或至少基本上垂直于基线801。在至少一个这种情况下,钉腿804和806可弯曲成使得轴线814和816彼此平行或至少基本上平行。在多种实施例中,再次参见图58,钉腿804和806可变形成使得它们不越过中心线803。钉腿804和806可变形成使得它们与基部802保持共面或至少基本上共面。
下述各种实例可被预想到,这些实例体现了上述多个实施例的一个或多个方面。此类实例为示例性的,并且本专利申请中所述的各种实施例的多个方面可合并在一个实施例中。在下述每个实例中,手术缝钉可包括限定基线的基部、从基部延伸的第一钉腿和第二钉腿、以及第一钉腿和第二钉腿之间的中线。
实例1
手术缝钉可变形成使得:
实例2
手术缝钉可变形成使得:
实例3
手术缝钉可变形成使得:
实例4
手术缝钉可变形成使得:
实例5
手术缝钉可变形成使得:
实例6
手术缝钉可变形成使得:
实例7
手术缝钉可变形成使得:
实例8
手术缝钉可变形成使得:
实例9
手术缝钉可变形成使得:
上述已变形缝钉中的若干种包括一个或多个越过缝钉基部中线的钉腿。在多种实施例中,因此,已变形钉腿可至少部分地相互重叠。更具体地讲,(从侧面观察)已变形钉腿可相配合从缝钉基部一端穿到另一端,其间不留间隙。此类实施例可特别有用,尤其在用于缝合血管组织时。更具体地讲,重叠的钉腿可挤压组织内的血管,无论血管在何处延伸穿过缝钉。钉腿之间有间隙或者变形时钉腿不沿缝钉基部全长延伸的缝钉可能不能够适当地挤压组织内的每条血管,因而一条或多条血管可能会渗漏。
在多种实施例中,除了上文所述,外科器械可构造成以上文所述和图50-52所示的方式调配多个缝钉400。在至少一个这种实施例中,外科缝合器可例如沿缝钉路径顺序地和/或同时地调配缝钉400。在某些实施例中,外科器械可构造成以上文所述和图55所示的方式调配多个缝钉600。在至少一个这种实施例中,与上文所述类似,外科缝合器可例如沿缝钉路径顺序地和/或同时地调配缝钉600。在多种实施例中,除了上文所述,外科器械可构造成以上文所述和图57所示的方式调配多个缝钉700。在至少一个这种实施例中,外科缝合器可例如沿缝钉路径顺序地和/或同时地调配缝钉700。
在多种实施例中,除了上文所述,手术缝钉可由钛构成,例如钛丝。在某些实施例中,手术缝钉可由含有例如钛、铝和/或钒的合金构成。在至少一个实施例中,手术缝钉可由例如外科不锈钢和/或合金构成,所述合金由钴和铬构成。在任何情况下,手术缝钉可由金属(例如钛)和金属氧化物外表面(例如氧化钛)构成。在多种实施例中,可用材料涂覆金属氧化物外表面。在某些实施例中,涂层材料可包括例如聚四氟乙烯(PTFE)(例如Teflon)和/或四氟乙烯(TFE)(例如乙烯-四氟乙烯(ETFE)、全氟烷氧基乙烯-四氟乙烯(PFA))和/或氟化乙烯丙烯(FEP)。某些涂料可包含硅。在多种实施例中,此类涂层材料可防止或至少阻碍金属进一步氧化。在某些实施例中,涂层材料可提供一个或多个润滑表面,砧座或缝钉凹腔可靠贴于这些表面而接触缝钉,以降低它们之间的摩擦力。在多种情况下,缝钉和缝钉凹腔之间的较低摩擦力可降低使缝钉变形所需的力。
本文公开的装置可被设计为在一次使用之后丢弃,或它们可被设计为多次使用。然而无论是哪种情况,该装置都可在至少使用一次后经过修复重新使用。修复的步骤可包括拆卸装置、清洗或更换具体部件以及后续重新组装步骤的任何组合。具体地讲,可拆卸该装置,并且可按照任何组合有选择地更换或拆下装置的任何数量的特定零件或部件。清洗和/或更换特定部件后,可在修理厂或在紧临外科手术前由外科手术小组将器械重新装配,以供后续使用。本领域的技术人员将会知道,修复装置的步骤可利用用于拆卸、清洁/更换和再组装的多种技术。这些技术的使用以及所得的修复装置均在本发明的范围内。
优选的是,本文所述的发明将在外科手术之前进行处理。首先,获取新的或用过的器械,并根据需要进行清洗。然后可对器械进行消毒。在一种消毒技术中,将器械置于闭合并密封的容器(诸如塑料或TYVEK口袋)中。然后将容器和器械置于可穿透该容器(诸如γ辐射、X射线或高能电子)的辐射场中。辐射将杀死器械上和容器中的细菌。然后可将消毒后的器械保存在消毒容器中。该密封容器将器械保持在无菌状态下,直到在医疗设备中打开该容器。
尽管已经将本发明作为示例性设计进行了描述,但还可以在本公开的精神和范围内对本发明进行修改。因此本发明旨在涵盖采用本发明一般原理的任何变型型式、用途或适应型式。此外,本发明旨在涵盖本发明之外但在本发明所属领域的已知或惯有实践范围内的偏差型式。

Claims (7)

1.一种外科缝合器,包括:
第一柄部,所述第一柄部包括被构造成接纳钉仓的钉仓通道;
第二柄部,所述第二柄部包括砧座;
可旋转闩锁;和
闩锁凸起,其特征在于,
所述闩锁可旋转地连接到所述第一柄部和所述第二柄部中的一个,并且其中所述闩锁凸起从所述第一柄部和所述第二柄部中的另一个延伸,其中所述闩锁被构造成接合所述闩锁凸起以使所述第一柄部和所述第二柄部彼此相向运动,其中所述闩锁凸起包括可旋转轴承,并且其中所述闩锁被构造成当所述闩锁接合所述闩锁凸起时接触所述可旋转轴承。
2.根据权利要求1所述的外科缝合器,其中所述闩锁凸起还包括轴部和从所述轴部延伸的增大部,其中所述轴承包括轴承孔,其中所述轴部延伸穿过所述轴承孔,其中所述可旋转轴承能够绕所述轴部旋转,并且其中所述增大部被构造成将所述可旋转轴承保持在所述轴部上。
3.根据权利要求1所述的外科缝合器,其中:
所述第一柄部包括可旋转地连接到所述钉仓通道的所述闩锁;
所述第二柄部包括支架;且
所述第一柄部还包括被构造成接纳所述闩锁凸起的凹陷;所述闩锁被构造成接合所述闩锁凸起并将所述闩锁凸起定位在所述凹陷内,以使所述第一柄部和所述第二柄部彼此相向运动;并且
所述闩锁凸起包括:
从所述支架延伸的轴部;
从所述轴部延伸的增大部;和
具有轴承孔的所述可旋转轴承,其中所述轴部延伸穿过所述轴承孔,其中所述可旋转轴承能够绕所述轴部旋转,其中所述可旋转轴承定位在所述支架和所述增大部中间。
4.根据权利要求1或3所述的外科缝合器,其中所述闩锁包括被构造成接纳所述闩锁凸起的闩锁凸起狭槽,其中所述闩锁凸起狭槽包括第一侧壁和第二侧壁,其中所述第一侧壁被定位成与所述第二侧壁相对,其中所述第一侧壁被构造成将闭合力施加到所述轴承以使所述第一柄部和所述第二柄部彼此相向运动,并且其中所述第二侧壁被构造成将开启力施加到所述轴承以使所述第一柄部和所述第二柄部彼此相离运动。
5.根据权利要求4所述的外科缝合器,其中所述轴承具有外径,其中所述第一侧壁和所述第二侧壁在它们之间限定狭槽宽度,并且其中所述外径略小于所述狭槽宽度。
6.根据权利要求3所述的外科缝合器,其中所述轴承孔具有圆形内轮廓,其中所述轴部具有圆形外轮廓,并且其中所述圆形外轮廓限定外径,此外径略小于由所述轴承孔的所述圆形内轮廓限定的内径。
7.根据权利要求3所述的外科缝合器,其中所述轴承孔由孔径限定,并且其中所述增大部由大于所述孔径的直径限定。
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IN2012DN03341A (zh) 2015-10-23
AU2010303713B2 (en) 2013-10-10
WO2011044026A3 (en) 2011-06-03
AU2010303708B2 (en) 2013-10-24
BR112012008269B1 (pt) 2020-11-24
US20110087276A1 (en) 2011-04-14
US8348129B2 (en) 2013-01-08
RU2552883C2 (ru) 2015-06-10
WO2011044032A3 (en) 2011-06-03
US20110084113A1 (en) 2011-04-14
CN102573664A (zh) 2012-07-11
BR112012008269B8 (pt) 2021-06-22
WO2011044020A1 (en) 2011-04-14
BR112012008251A2 (pt) 2016-03-08
CA2777039A1 (en) 2011-04-14
BR112012008269A2 (pt) 2016-03-15
RU2538048C2 (ru) 2015-01-10
WO2011044032A2 (en) 2011-04-14
PL2485655T3 (pl) 2017-05-31
BR112012008251B1 (pt) 2020-01-28
AU2010303708A1 (en) 2012-04-19
EP2485656B1 (en) 2018-05-30
US8141762B2 (en) 2012-03-27
EP2485655A1 (en) 2012-08-15
EP2485655B1 (en) 2016-11-23
CN102573663A (zh) 2012-07-11
CA2777026A1 (en) 2011-04-14
IN2012DN02855A (zh) 2015-07-24
CA2777039C (en) 2018-03-27
EP2485656A2 (en) 2012-08-15
WO2011044026A2 (en) 2011-04-14
US20110084115A1 (en) 2011-04-14
CA2777026C (en) 2017-12-19
CN102573663B (zh) 2015-04-22
RU2012118642A (ru) 2013-11-20
AU2010303713A1 (en) 2012-04-12

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