CN103052361B - 用于外科圆形缝合器的透过壁可视化装置 - Google Patents

用于外科圆形缝合器的透过壁可视化装置 Download PDF

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CN103052361B
CN103052361B CN201180037357.1A CN201180037357A CN103052361B CN 103052361 B CN103052361 B CN 103052361B CN 201180037357 A CN201180037357 A CN 201180037357A CN 103052361 B CN103052361 B CN 103052361B
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F·E·谢尔顿四世
J·W·威利斯
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Ethicon Endo Surgery Inc
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Abstract

本发明公开了一种外科器械。多个实施例包括细长轴,所述细长轴限定中心轴线并且具有远端部分,所述远端部分能够可操作地支撑其中的圆形钉仓。至少一个检测构件能够被可操作地支撑在细长轴内。每个检测构件均可具有远侧部分,在向检测构件施加部署运动时,远侧部分可远离中心轴线径向地部署。远端部分可具有安装到远端部分的缓冲器或光源。

Description

用于外科圆形缝合器的透过壁可视化装置
技术领域
本发明整体涉及外科缝合器,并且更具体地讲本发明涉及用于保持和/或保护邻近圆形缝合器的缝合器头部的组织的装置和方法。
背景技术
在某些类型的外科手术中,外科缝钉的使用已成为接合组织的优选方法,并且因此已开发出用于这些应用的具有特殊构造的外科缝合器。例如,已开发出腔内缝合器或圆形缝合器以用于涉及低位结肠的外科手术,其中在病变部分已被切除之后将低位结肠的各部分接合在一起。用于执行此类手术的圆形缝合器公开于例如美国专利No.5,104,025、No.5,205,459、No.5,285,945和No.5,309,927中,这些专利均以相应的全文引入本文以供参考。
一般来讲,常规的圆形缝合器通常由具有近侧致动机构的细长轴和安装到该细长轴的远侧缝合器头部组成。远侧缝合器头部通常由固定的钉仓组成,钉仓内包含能够同心圆阵列的多个缝钉。圆形切刀在缝钉内被同心地安装在钉仓中以用于在其中轴向行进。从钉仓的中心轴向地延伸的是可运动的套管针轴,该套管针轴能够将缝钉砧可拆卸地联接到其上。在将缝钉驱入砧中时砧能够使缝钉的末端成形。钉仓的远侧表面与缝钉砧之间的距离通常由调节机构控制,调节机构被安装在缝合器轴的近端以用于控制套管针的轴向运动。当外科医生启动致动机构时,同时缝合和切割被夹持在钉仓和缝钉砧之间的组织。
当用圆形缝合器执行下部结肠手术时,可用穿过套管针插入的常规手术缝合器对肠的一部分进行腹腔镜下缝合。常规的手术缝合器用于将多排缝钉放置到待切除的结肠的病变部分的任一侧上。在缝合结肠的毗邻端时,同时切割目标部分或病变部分。在切除病变部分之后,外科医生通常将圆形缝合器械的砧插入缝合线远侧的腔管的远端中。这可通过将砧头部插入外科医生在远侧腔管切开的入口中来完成。用下部缝合线将结肠的组织保持在圆形仓之上。该方法密封结肠的两端,使得密封的部分被切穿和移除。这些中间步骤缝合线仅是暂时的并且有利于手术的下一个步骤。
有时,砧可经肛门放置,即通过将砧头部放在缝合器的远端上并通过直肠插入器械。一旦将砧插入肠的远侧部分,就用称为“荷包”缝合的方式将肠固定在砧轴周围。相似地通过荷包缝合将肠的近侧部分固定在缝合器头部周围。
一旦将肠的末端固定在它们相应的元件周围,外科医生即可通过合适的套管针套筒用抓持装置来抓持砧轴并将其附接到突出到缝合器头部内的套管针部分。然后外科医生合拢砧和钉仓之间的间隙,从而将肠的近端和远端夹紧在间隙中。外科医生随后启动缝合器,从而驱动多排缝钉穿过肠的两端并使其成形,因此接合末端并形成管状通道。同时,在驱动并形成缝钉时,可驱动同心的环形刀片穿过肠组织末端,从而切割邻近内排缝钉的末端。然后,外科医生从肠中取出缝合器并完成手术。
此类外科手术和装置需要外科医生安装两条荷包缝合线,这延长了完成外科手术所需的时间。此外,此类外科手术在组织切割/缝合过程中有时使组织“聚束”。
已进行多种尝试以使结肠和其它组织保留在缝合装置周围。例如,美国专利No.5,309,927、No.6,117,148和No.7,094,247公开了多种装置,除了缝合装置本身,一般来讲还采用紧固件、连接构件、环、弹簧等试图将保持组织固定。美国专利No.5,669,918公开了一种机构,其采用类似臂的抓持器以摩擦方式使组织紧靠套管针柄而固定。尽管此类装置基本上是自含式的,但实际上抓持器臂最后可能不能有效地将组织保持就位。
因此,需要的是可缩短完成外科手术所需的时间以及可解决与当采用圆形缝合器装置时将组织保持就位的相关的其它缺点和困难的装置和方法。
上述讨论仅仅为了举例说明本技术领域内目前存在的一些不足之处,而不应看作是对权利要求范围的否定。
发明内容
根据本发明的各个非限制性实施例的一个总体方面,提供了一种外科器械,该外科器械包括细长轴,细长轴限定中心轴线并且具有远端部分,远端部分能够可操作地支撑其中的圆形钉仓。至少一个检测构件被可操作地支撑在细长轴内。每个检测构件均具有远侧部分,在向检测构件施加部署运动时,远侧部分可远离中心轴线径向地部署。光源可被设置在检测构件的远侧部分上。
根据本发明的多个非限制性实施例的另一个大体方面,提供了一种外科器械,该外科器械包括柄部组件,柄部组件具有从其突出的细长轴。细长轴限定中心轴线并且具有远端部分,远端部分能够可操作地支撑其中的圆形钉仓。至少一个检测构件被可操作地支撑在细长轴内。每个检测构件均具有远侧部分,在向检测构件施加部署运动时,远侧部分可远离中心轴线径向地部署。至少一个采集构件被可操作地支撑在细长轴内。每个采集构件均具有组织穿刺远侧部分,在向采集构件施加部署运动时,组织穿刺远侧部分可远离中心轴线径向地部署。
根据本发明的各个非限制性实施例的另又一个大体方面,提供了一种外科器械,该外科器械包括柄部组件,柄部组件具有从柄部组件突出的细长轴。细长轴限定中心轴线并且具有远端部分,远端部分能够可操作地支撑其中的圆形钉仓。至少一个检测构件被可操作地支撑在细长轴内。每个检测构件均具有远侧部分,在向检测构件施加部署运动时,远侧部分可远离中心轴线径向地部署。至少一个柔性的刀构件被可运动地支撑在细长轴中。每个刀构件均具有远侧切割部分,在向刀构件施加轴向致动运动时,远侧切割部分可轴向地行进到细长轴的远端部分之外。在向刀构件施加旋转致动运动时,每个刀构件均可围绕中心轴线选择性地旋转。
根据本发明的各个非限制性实施例的又一个大体方面,提供一种用于处理管状器官的外科手术。在各个非限制性实施例中,手术包括将外科器械的圆形缝合器头部插入管状器官中。手术还包括将由外科器械可操作地支撑的至少一个发光检测构件从回缩位置部署至邻近管状器官的壁的部署位置。手术还包括透过器官壁观察来自发光检测构件的光源,以判断圆形缝合器头部在管状器官内的位置。
附图说明
被并入本文中并且构成本说明书的一部分的附图示出了本发明的实施例,并且与上文所给出的一般说明和下文所给出的详细说明一起用于解释本发明的原理。
图1为本发明的多个非限制性实施例的外科圆形缝合器械的透视图;
图1A为本发明的外科缝合器械的多个实施例的柄部的剖视图;
图2为图1的圆形缝合器械的细长轴的远端部分的剖视图;
图2A为具有联接到其上的砧的细长轴的远端的局部剖视图;
图2B为沿图2A的线2B-2B截取的细长轴的远端的局部剖视图;
图2C为本发明的实施例的柄部组件的一部分的剖视图;
图2D为本发明的多个实施例的细长轴的另一部分的剖视图;
图3为图2的细长轴的端视图;
图4为图2和3的细长轴的远端部分的局部透视图,其中组织采集构件及其刀构件处于它们的径向地部署位置;
图5为细长轴的远端的局部剖视图,细长轴的远端具有联接到其上的砧并且被插入患者的管状器官例如结肠的一部分中;
图6为图5的细长轴的远端的另一个剖视图,其中已将砧从细长轴的远端移除;
图7为图5和6的细长轴的远端的另一个剖视图,其中切割器外壳的远端部分轴向地行进超过被支撑在细长轴远端内的钉仓的远侧表面;
图8为图7的细长轴的远端的另一个剖视图,其中组织采集构件离开组织采集外壳径向地部署并刺穿结肠的一部分;
图9为图8的细长轴的远端的另一个剖视图,其中细长轴的远端的组织采集构件撤回到组织采集外壳内,以将结肠的被刺穿部分定位成邻近钉仓的远侧表面;
图10为图9的细长轴的远端的另一个剖视图,其中刀构件离开切割器外壳径向地部署并刺穿结肠的另一部分;
图11为图10的细长轴的远端的另一个剖视图,其中已旋转刀构件以将结肠的保持的被刺穿的部分从结肠的病变部分切断;
图12为图11的细长轴的远端的另一个剖视图,其中刀构件已撤回到它们在切割器外壳中对应的腔中;
图13为图12的细长轴的远端的另一个剖视图,其中已将砧固定到结肠的远侧部分并且已将其砧杆联接到圆形缝合器械的砧组件部分;
图14为图13的细长轴的远端的另一个剖视图,其中已将砧拉动至邻近钉仓的远侧表面;
图15为图14的细长轴的远端的另一个剖视图,其中缝钉已被部署,并且环形刀已轴向地行进穿过结肠的相邻部分;
图16为图15的细长轴的远端的另一个剖视图,其中结肠部分已缝合在一起,但细长轴还未从结肠取出;
图17为本发明的多个非限制性实施例的外科圆形缝合器械的透视图;
图18为图17的圆形缝合器械的细长轴的远端部分的剖视图;
图19为本发明的多个非限制性实施例的采集和部署轴的分解装配视图;
图20为图19的采集轴的局部透视图,其中采集轴的组织臂处于回缩位置;
图21为图19和20的采集轴的局部剖视图,其中采集轴的组织臂处于部署位置;
图22为图21的采集轴的透视图;
图23为本发明的多个非限制性实施例的细长轴的剖视图,其中砧附接到细长轴并插入患者的结肠的一部分中;
图24为图23的细长轴的另一个剖视图,其中砧已被移除并且采集臂部署穿过结肠的邻近结肠的目标部分或病变部分的近侧部分;
图25为沿图24中的线25-25截取的图24的细长轴的顶部剖视图,其中组织采集臂延伸穿过结肠的近侧部分;
图26为图24和25的细长轴的局部剖视图,其中正在用抓持器械移除结肠的目标部分或病变部分;
图27为沿图26中的线27-27截取的图26的细长轴的顶部剖视图;
图28为细长轴的局部剖视图,其中已将砧插入结肠的远侧部分中并用荷包缝合装置固定到其上;
图29为图28的细长轴的剖视图,其中已将砧连接到其砧组件并将其拉动成与其中的钉仓成面对关系;
图30为图29的细长轴的剖视图,其中钉仓已被击发并且环形切割构件行进穿过被缝合的组织部分;
图31为完成缝合手术后正从结肠取出的图30的细长轴的剖视图;
图32为本发明的多个非限制性实施例的另一个外科圆形缝合器械的透视图;
图33为图32的圆形缝合器械的细长轴的远端部分的剖视图;
图34为图33的细长轴的钩和检测外壳部分的局部透视图,其中它的检测构件处于回缩位置;
图35为图34的钩和检测外壳的另一个局部透视图,其中它的检测构件呈部署取向;
图36为细长轴的远端的局部剖视图,其中它的检测构件在结肠内呈部署取向;
图37为沿图36中的线37-37截取的图36的细长轴和结肠的顶部剖视图;
图38为本发明的多个非限制性实施例的另一个圆形缝合器械的透视图;
图39为图38的圆形缝合器械的细长轴的远端部分的剖视图,其中细长轴的远端部分已插入管状器官(例如结肠)的近侧部分中;
图40为本发明的多个非限制性实施例的组织采集轴、部署轴和刀轴的远端部分的分解装配视图;
图41为图40的组织采集轴的局部透视图,其中组织采集轴的组织臂处于回缩位置;
图42为图41的采集轴的透视图,其中采集轴的组织臂处于部署位置;
图43为插入结肠的近侧部分的图38的外科器械的细长轴的远端部分的局部剖视图,其中已将砧组件从细长轴的远端部分移除;
图44为细长轴的远端部分的局部剖视图,其中组织采集臂部署穿过结肠的近侧部分;
图45为沿图44中的线45-45截取的细长轴的远端部分的顶部剖视图;
图46为细长轴的远端部分的另一个局部剖视图,其中组织采集臂已部署穿过结肠的近侧部分,然后运动至回缩位置,其中刺穿的近侧部分被捕集在组织采集臂与组织采集轴之间;
图47为沿图46中的线47-47截取的图46的细长轴的远端部分的顶部剖视图;
图48为细长轴的远端部分的局部剖视图,其中正将结肠的病变部分朝近侧部分和远侧部分切断并通过常规抓持器将其从结肠移除;
图49为细长轴的局部剖视图,其中已将砧插入结肠的远侧部分中并用荷包缝合装置将其固定到远侧部分;
图50为图49的细长轴的剖视图,其中已将砧联接到其砧组件并将其拉动成与其中的钉仓成面对关系;
图51为图50的细长轴的剖视图,其中钉仓已被击发并且环形切割构件行进穿过被缝合的组织部分;
图52为缝合手术完成后正从结肠取出的图51的细长轴的剖视图;
图53为患者的打开的腹腔的一部分的视图,其中示出了邻近结肠的一部分的多个组织和结构;
图54为图53的打开的腹腔的另一个局部视图;
图55为图53的腹腔的另一个视图,其中示出了将套管针插入腹腔以将本发明的保护护套实施例递送至其中;
图56为图55的腹腔的另一个视图,其中正用常规的抓持装置将保护护套实施例从套管针套筒中取出;
图57为图56的腹腔的另一个视图,其中示出了围绕待处理的结肠的一部分的周围定位保护护套的一种方法;并且
图58为图57的腹腔的另一个视图,其中保护护套实施例已被定位成围绕待处理的结肠部分的外周。
具体实施方式
本申请的申请人还拥有以下的美国专利申请,这些专利申请与本申请同一天提交,并且其每个均以其相应的全文引入本文以供参考:
序列号为_________、名称为“SurgicalCircularStaplerWithTissueRetentionArrangements”、代理人案卷号为END6741USNP/100065的美国专利申请;
名称为“TissueAcquisitionArrangementsandMethodsForSurgicalStaplingDevices”、序列号_________、代理人案卷号为END6739USNP/100063的美国专利申请;
名称为“CircularStaplingInstrumentsWithSecondaryCuttingArrangementsandMethodsofUsingSame”、序列号________、代理人案卷号为END6740USNP/100064的美国专利申请;以及
名称为“ApparatusandMethodsForProtectingAdjacentStructuresDuringtheInsertionofaSurgicalInstrumentIntoaTubularOrgan”、序列号_________、代理人案卷号为END6737USNP/100061的美国专利申请。
现在将描述某些示例性实施例,以提供对本文所公开的装置和方法的结构、功能、制造和用途的整体理解。这些实施例的一个或多个实例示出于附图中。本领域的普通技术人员将会理解,在本文中具体描述并示出于附图中的装置和方法为非限制性的示例性实施例,并且本发明的多个实施例的范围仅由权利要求书限定。
本说明书通篇引用的“多个实施例”、“一些实施例”、“一个实施例”或“实施例”等,是指结合所述实施例描述的具体特征、结构或特性包括在至少一个实施例中。因此,本说明书通篇出现的短语“在多个实施例中”、“在一些实施例中”、“在一个实施例中”或“在实施例中”等并不一定均指相同的实施例。此外,在一个或多个实施例中,具体特征、结构或特性可按任何合适的方式结合。因此,在没有限制的情况下,结合一个实施例示出或描述的具体特征、结构或特性可全部或部分地与一个或多个其它实施例的特征、结构或特性结合。这种修改形式和变化形式旨在涵盖于本发明的范围之内。
本文所用术语“近侧”和“远侧”是相对于操纵外科器械柄部的临床医生而言的。术语“近侧”是指最靠近临床医生的部分,并且术语“远侧”是指远离临床医生的部分。还应当理解,为简洁和清楚起见,本文可结合附图使用例如“竖直”、“水平”、“上”和“下”之类的空间术语。然而,外科器械在许多方向和位置中使用,并且这些术语并非限制性的和/或绝对的。
图1示出了根据本发明的多个非限制性实施例的圆形缝合器10。在多个实施例中,圆形缝合器10包括柄部组件12,该柄部组件12具有从其突出、限定中心轴线A-A的细长轴组件14。细长轴组件14包括刚性外部护套16,该刚性外部护套16具有形成缝合器头部20的远端部分17。在多个非限制性实施例中,缝合器头部20能够可操作地支撑其中的圆形钉仓30。此类圆形钉仓30是本领域已知的,并且通常可在其中支撑一排、两排或更多排周向间隔和交错的缝钉36。参见图2和图3。例如,图3中所示的实施例具有两排(32、34)缝钉36。常规的环形刀40被同轴地且可运动地支撑在缝合器头部20内。
在某些具体实施中,圆形缝合器10还包括击发轴组件50,击发轴组件50被支撑在外部护套16内以用于在其中选择性地轴向行进。参见图2。击发轴组件50的远端部分52在其上具有外部缝钉驱动器部分54,其用于与钉仓30中的缝钉36的外排32中的每颗缝钉36接合。此外,击发轴组件50的远端部分52具有内部缝钉驱动器部分56,其能够与钉仓30中的缝钉36的内排34中的每颗缝钉36接合。如也可在图2中所见,例如击发轴组件50的远端部分52还具有能够接合环形刀40的凸缘58。因此,如将在下文中进一步详细讨论,击发轴组件50沿远侧方向“DD”的轴向行进将使得缝钉36被驱动到钉仓30之外并且使得环形刀40朝远侧行进。如在图2A中可见,击发轴组件50具有联接到击发杆53的基座部分51。
在多个非限制性实施例中,击发杆53可操作地与可操作地联接到柄部组件12的击发触发器60交接。参见图1和图1A。如在图1和1A中可见,击发触发器60可枢转地联接到柄部组件12,使得当击发触发器60朝柄部组件12枢转时,击发轴组件50沿远侧方向DD运动。此类击发触发器装置在本领域中是已知的,并且因此将不在本文详细讨论。例如,示例性的击发触发器装置公开于名称为“SurgicalStaplingInstrumentWithMechanicalIndicatortoShowLevelsofTissueCompression”的美国专利申请公布No.US2008/0078806A1中,该专利的公开内容全文引入本文以供参考。
如图2和2A中所示,多个非限制性实施例包括采集外壳70,其被同轴地支撑在击发轴组件50内并可相对于击发轴组件50轴向地运动。采集外壳70在其中具有多个采集腔72,每个采集腔均可运动地支撑采集或钩构件80。如在图3中可见,例如,多个三面采集腔72可等间隔地围绕采集外壳70的周围。在图3所示的非限制性实施例中,总共八(8)个采集腔72等间隔地围绕采集外壳70的周围。
每个采集或钩构件80可由例如镍钛诺、300或400系列不锈钢(完全硬化或四分之三硬化)制成,并且当行进到其相应的采集腔72之外时,具有如图4所示径向地向外弯曲的远端部分82。还如在图4中可见,每个钩构件80均具有在其远端部分82上形成的组织倒钩84。如在图2和3中可见,在多个非限制性实施例中,采用套筒78以有利于将钩构件80安装到它们相应的腔72中。
如在图2A中可见,每个钩构件80均联接到采集环81或从采集环81突出,采集环81具有一对附接到其上的采集杆83。采集杆83附接到被可操作地支撑在柄部组件12上的钩开关90。参见图1和图2C。在外科医生沿远侧方向(图1和2C中的箭头92)使钩开关90运动时,采集外壳70朝远侧运动。采集外壳70的此类运动使每个钩构件80的远端部分84朝远侧行进到其相应的采集腔72之外。在每个钩构件80的远端部分84行进到采集腔72之外时,钩构件80的自然弯曲动作使端部84径向地弯离中心轴线A-A,如图4所示。外科医生可通过沿近侧方向(图1和2C中的箭头94)使钩开关90运动而将采集外壳70和钩构件80回缩到它们的起始位置(图2)。
如在图2、2A、2D、3和4中还可看出,在多个非限制性实施例中,切割器外壳100被同轴地支撑在采集外壳70内。支撑切割器外壳100以便相对于采集外壳70选择性地轴向行进并沿中心轴线A-A选择性地轴向行进。在多个实施例中,一对外壳致动杆101从切割器外壳100突出,以与被可运动地支撑在柄部组件12上的刀旋钮110交接。参见图1和图2D。在多个非限制性实施例中,刀旋钮110被支撑在柄部组件12上,使得其可轴向地运动(在图1和2D中以箭头112、114表示),并还可相对于柄部组件12旋转(在图1中以箭头116表示)。外壳致动杆101联接到刀旋钮110,使得刀旋钮110沿轴向的运动在采集外壳70内使切割器外壳100轴向地运动,并且刀旋钮110的旋转还使切割器外壳100围绕中心轴线A-A旋转,如下文将详细讨论的那样。
在多个非限制性实施例中,切割器外壳100包括至少一个,并且优选地多个轴向地延伸穿过切割器外壳100的壁的刀腔102。如在图3中可看出,例如,多个刀腔102可等间隔地围绕切割器外壳100的周围。在图3中所示的非限制性实施例中,总共八(8)个刀腔102等间隔地围绕切割器外壳100的周围。如在图2和4中可看出,每个刀腔102均具有径向地向外打开的弯曲的远端部分104。
在多个非限制性实施例中,柔性的刀构件120被可滑动地容纳在每个刀腔102内。每个柔性的刀构件120均具有尖锐的远端122并附接到刀环123或从刀环123突出。一对刀致动杆125通过滑动接头装置127附接到刀环123,滑动接头装置127允许刀环123相对于致动杆125旋转。参见图2A。如在图2C中可见,刀致动杆125(该图中只示出了一个刀致动杆125)附接到刀开关130,刀开关130可操作地安装在柄部12。每个刀构件120的远端122均为基本上尖的,以使得其能够刺穿组织并且其可具有至少一个在其上形成的切割边缘124。当沿远侧方向(箭头132)使刀开关130运动时,刀构件120在刀腔102内朝远侧运动,使得尖锐的远端122“自然地”挠曲或径向地弯曲到腔102的弯曲的远端部分104之外,如图4所示。如本文所用,术语“自然地”是指材料可经受预应力,或换句话讲将材料形成为使得在材料离开腔时其远端挠曲或弯曲。同样,刀开关130沿近侧方向(在图1和2C中用箭头134表示)的运动使每个刀构件120回缩到其刀腔102中。在多个非限制性实施例中,刀构件120可由例如镍钛诺、300或400系列不锈钢(完全硬化或四分之三硬化的)制成。
如在图2A中还可见,击发轴组件50具有远端柱140,其从基座部分51突出并在切割器外壳100内同轴地延伸以用于在其中选择性地轴向行进。多个实施例还包括安装在外部护套116内的隔壁构件141。为了有利于装配,外部护套16可包括远侧外部护套部分16和近侧外部护套部分16’,如图2A所示。此外,远端柱142从隔壁51延伸并支撑远侧砧连接器150。远侧砧连接器150联接到远侧带组件151。远侧带组件151联接到控制杆组件153,控制杆组件153与被可旋转地支撑在柄部组件12上的调节旋钮160交接。此类砧轴组件和控制旋钮装置通常是已知的。例如,可根据名称为“SurgicalStaplingInstrumentWithMechanicalIndicatorToShowLevelsofTissueCompression”的公布的美国专利申请No.US2008/0078806A1中所公开的来构造控制杆组件和控制旋钮,该专利引入本文以供参考。
如在图2B中可看出,每个外壳致动杆101突穿隔壁141中的对应的弓形槽145。可将槽145的尺寸设定成限定/限制切割器外壳100可相对于中心轴线A-A旋转的量。例如,在一个其中使用总共八(8)个刀构件120的实施例中,可将槽145的尺寸设定成有利于切割器外壳100围绕中心轴线A-A弓形地或旋转地行进至少大约45°-50°。隔壁141还可具有允许远侧带组件151突穿隔壁141的孔146。此外,每个刀致动杆125均延伸穿过隔壁141中对应的开口147。相似地,每个采集杆83延伸穿过隔壁141中对应的孔148。参见图2B。
圆形缝合器10还包括砧170,如图5所示。在多个非限制性实施例中,砧170包括砧基座171和砧轴174,砧基座171里面具有一系列缝钉成型袋172,砧轴174可拆卸地附接到远侧砧连接器150上。具体地讲,联接杆176从砧轴174的近端175突出,并且尺寸设定成被可滑动地容纳在远侧砧连接器150的通道152中。在砧170上还具有砧盖178,如图5和13所示,砧盖178限定其中的组织腔体179。
将参照图5-16描述使用圆形缝合器10的一个示例性方法。圆形缝合器10的多个实施例尤其适用于执行管状器官,例如结肠,的环形吻合术。首先转到图5,将缝合器头部20通过患者肛门199插入结肠200的近侧部分201。在其中切除结肠的病变或目标部分202的应用中,缝合器头部20被定位在邻近病变部分202的地方。参见图6。
一旦将缝合器头部20插入相对于病变部分202的合适位置,就通过使刀旋钮110沿远侧方向(用图1和7中的箭头112表示)轴向地行进,而使切割器外壳100朝远侧行进。在手术的该阶段,刀构件120未行进到它们相应的刀腔102之外。其后,外科医生通过沿远侧方向(图1中的箭头92)使钩开关90运动而使采集外壳70朝远侧行进。采集外壳70沿远侧方向的运动使钩构件80轴向地运动到它们的相应采集腔72之外。当钩构件80的远端从它们的相应的采集腔72退出时,它们自然地向外径向地挠曲,从而接合并刺穿结肠200的近侧部分201。参见图8。一旦钩构件80刺穿并接合结肠200的近侧部分201,外科医生即沿近侧方向(用图1中的箭头94表示)使钩开关90运动,从而将钩构件80回缩到它们的相应采集腔72中,以及将采集外壳100回缩至其起始位置。在钩构件80远端上的倒钩84将被接合的近侧部分201拉动至图9所示的位置。因此,结肠200的被接合的近侧部分201被拉动到钉仓30的远侧表面31之上,并且部分地进入钉仓30与切割器外壳100之间的内部空间33。
一旦结肠200的被接合的近侧部分201被拉动至图9所示的位置,外科医生即通过沿远侧方向(用图1中的箭头112表示)使柄部组件12上的刀旋钮110轴向地行进而使刀构件120从它们相应的刀腔102延伸出来。通过使刀旋钮110朝远侧运动,使刀构件120行进到它们的刀腔102外面,并且每个刀腔102的弯曲部分104使其中的刀构件120径向地向外运动,如图10所示。刀构件120突入邻近结肠病变部分202的结肠200的近侧部分201。参见图10。其后,可通过旋转柄部组件12上的刀旋钮110(用图1中的箭头116表示)而将结肠病变部分202从近侧结肠部分201切下。刀旋钮110的旋转/致动将使切割器外壳100和刀构件120围绕中心轴线A-A旋转并切穿结肠组织。将病变部分202从近侧结肠部分201切除之后(图11),外科医生可通过沿近侧方向(用图1中的箭头114表示)使刀旋钮110运动而使刀构件120回缩到它们相应的刀腔102内。参见图12。
可用例如穿过延伸到邻近病变部分202的腹腔601中的套管针套筒插入的常规腹腔镜式组织切断装置(未示出)来将病变部分202从远侧结肠部分208切断(图13)。然后可通过套管针套筒移除结肠病变部分202。然后,外科医生调节砧170在远侧结肠部分206内的方向,使得砧轴174突出到远侧结肠部分206之外,如图13所示。外科医生然后使用在本领域中称为“荷包缝合”220的方法将远侧结肠部分206的末端围绕砧轴174系扎。一旦将远侧结肠部分206围绕砧轴174系扎后,则将砧轴174的联接杆176插入砧轴组件150的通道152中。联接杆176的尺寸可相对于通道152设定以在它们之间建立摩擦配合,从而在其中保持联接杆176,但允许联接杆176在以后从其移除。
外科医生然后通过沿合适的方向旋转砧控制旋钮160以朝缝合器头部20拉动砧170(沿近侧方向“PD”),直到结肠部分205、210被夹持在砧170与钉仓30之间,如图14所示。其后,外科医生启动击发触发器60以沿远侧方向“DD”使击发轴组件50轴向地行进。在击发轴组件50朝远侧行进时,外部缝钉驱动器部分54和内部缝钉驱动器部分56用于分别驱动位于外排32和内排34中的缝钉36,使其穿过结肠部分205、210,进入砧基座171中的砧成型袋172。击发轴组件50还使环形刀40行进穿过结肠部分205以将部分201从其切下。参见图15。环形刀40进一步行进,将结肠部分207从结肠部分208切断。然后外科医生沿远侧方向“DD”使砧170运动,以便从砧基座171与钉仓30的表面31之间释放缝合的结肠部分205、210。参见图16。然后可将器械10从结肠200移除。在外科医生通过患者的肛门199取出器械10时,切割部分201保留在缝合器头部20中,并且切割部分207保留在砧170中的组织腔体179中。因此,当将器械从结肠取出时,将结肠200的切断部分201、207从经修复的结肠移除。
图17示出了根据本发明的多个非限制性实施例的另一种圆形缝合器300。圆形缝合器300通常包括具有从其突出的细长轴314的柄部组件312。细长轴314可限定中心轴线A-A。如从图17中可看出,细长轴314包括将缝合器头部320支撑在其上的刚性外部护套316。在多个非限制性实施例中,缝合器头部320能够支撑其中的圆形钉仓330。此类圆形钉仓330是本领域已知的,并且通常在其中支撑一排或两排或更多排周向间隔和交错的缝钉36,如上文所述。常规的环形刀340同轴地且可运动地支撑在钉仓330内。参见图18。
在某些具体实施中,圆形缝合器300还包括击发轴350,击发轴350被可操作地支撑在刚性外部护套316内,以便在其中选择性地轴向运动,如上文所述。参见图18。击发轴350的远端部分352在其上具有外部缝钉驱动器部分354以用于与钉仓330内缝钉36的外排32中的每颗缝钉36接合。此外,击发轴350的远端部分352还具有内部缝钉驱动器部分356,其能够与钉仓330内缝钉36的内排34中的每颗缝钉36接合。如也可在图18中所见,例如,击发轴350的远端部分352还具有能够接合环形刀340的凸缘部分358。因此,如将在下文中进一步详细讨论,击发轴350沿远侧方向“DD”轴向地行进将使得缝钉36被驱动到钉仓330之外,以及使环形刀340朝远侧行进。
在多个非限制性实施例中,击发轴350与可操作地连接到柄部组件312的击发触发器360交接。如在图17中可见,击发触发器360可枢转地联接到柄部组件312,使得当击发触发器360朝柄部组件312枢转时,击发轴350沿远侧方向DD运动。如上所讨论,此类击发触发器装置在本领域中是已知的,并因此将不在本文详细讨论。
如图18所示,多个非限制性实施例还包括部署轴370,其被同轴地且可旋转地支撑在组织采集轴380内,组织采集轴380以非旋转方式被支撑在细长轴316内。部署轴370的近端可操作地与被可旋转地支撑在柄部组件312上的组织采集旋钮310交接。部署轴370以上文结合刀旋钮110所述的方式与组织采集旋钮310交接。因此,组织采集旋钮310在柄部组件312上的旋转/启动将使得部署轴370在组织采集轴380内围绕中心轴线A-A旋转。更具体地讲并结合图19,在多个实施例中,部署轴370的远端372突入采集轴380中的孔382并具有连接到其上的驱动齿轮374。采集轴380的远端384能够可操作地在其上支撑至少两个组织采集构件或组织臂400。在图19所示的非限制性实施例中,总共四个组织臂400通过相应的销386可枢转地插到组织采集轴380的远端384,使得每个组织臂400围绕对应的基本上平行于中心轴线A-A的“采集”轴线B-B旋转。参见图21和23。
如可在图19和22中所见,每个组织臂400具有可由例如不锈钢(300或400系列)或钛-钢复合材料或陶瓷等制成的主体部分402,并具有连接到其上或在其上形成的从动齿轮404。每个组织臂400的从动齿轮404被可运动地支撑在形成于组织采集轴380的远端384中的对应臂腔388内。每个从动齿轮404与部署轴370上的驱动齿轮374啮接。因此,部署轴370的旋转将使得组织臂400从图20所示的回缩位置枢转式部署到图22所示的部署位置。如在图20和22中可见,在多个实施例中,每个组织臂400具有弓形形状,使得当组织臂400处于如图20中所示的回缩位置时,它们在组织采集轴380的远端处共同形成圆盘状组件401。
在多个实施例中,每个组织臂400的主体部分402进一步具有在其上形成的或换句话讲连接到其上的组织穿刺末端406。此外,在其上形成有切割边缘410的臂刀408联接到每个组织臂400的主体部分402上或换句话讲在其上形成。在多个实施例中,臂刀408可由例如不锈钢(300或400系列)或钛-钢复合材料或陶瓷等制成,并可通过焊接或其它合适的连接方法(取决于材料)连接到对应的组织臂400的主体部分402。在优选的实施例中,如果臂刀408由上文指出的任何金属材料制成,则可能期望此类材料是硬化的。例如,38-52的洛氏硬度值可为期望的。在可供选择的实施例中,可将臂制造为具有薄结构,可将该薄结构磨成锋利边缘。如通过本发明具体实施方式的描述将会了解到,刀片的工作方式更像剪刀而不是刀,因为当它闭合时进行切割,使得408紧靠421时,它可将组织剪断。如在图19中还可见,剪切板420通过延伸到臂轴380中的螺纹紧固件孔424内的螺纹紧固件422附接到臂轴380的远端382。还在多个实施例中,多个组织采集销426等间隔地围绕组织采集轴380的周围并从其径向地突出。当组织臂400运动至它们的回缩位置时,剪切板420的外边缘421与组织臂400上的切割边缘410合作剪断在那些边缘410、421之间被拉动的组织。
在某些具体实施中,远端柱442从击发轴350的一部分突出,该击发轴350的一部分在部署轴370内同轴地延伸以在其中选择性轴向地行进。远端柱442在其中支撑连接到调节旋钮460的远侧砧连接器450,而调节旋钮则以上述多种方式被可旋转地支撑在柄部组件312上。
圆形缝合器300还包括砧470,如图18所示。在多个非限制性实施例中,砧470包括在其中具有一系列缝钉成型袋472的砧基座471。砧基座471还可限定剪切边缘473以有利于通过环形刀340来剪切组织。砧470还包括可拆卸地连接到远侧砧连接器450的砧轴474。具体地讲,联接杆476从砧轴474的近端475突出,并且尺寸设定成可滑动地容纳在砧轴组件450的通道452中。参见图23。砧组件470上还具有砧盖478,它用于限定其中的组织腔体479,如图18和23中所示。如在图18中还可见,盘状组件401的尺寸设定成延伸到砧基座471中的开口475中。
将参考图23-31描述使用圆形缝合器300的一个示例性方法。圆形缝合器300的多个实施例尤其适用于执行管状器官,例如结肠200,的环形吻合术。首先转到图23,将缝合器头部320通过患者的肛门199插入结肠200的近侧部分201。当切除结肠200的病变或换句话讲目标部分202时,缝合器头部320被定位在将病变部分202从近侧部分201切断的区域中。
一旦将缝合器头部320正确地设置在结肠内,便可通过沿第一方向(用图17中的箭头311表示)旋转组织采集旋钮310(这也使部署轴370旋转)而使组织臂400被径向地部署。部署轴370沿第一方向的旋转也使与每个组织臂400的从动齿轮部分404啮接的驱动齿轮374旋转。因此,驱动齿轮374沿第一方向的旋转使得组织臂400被径向地部署。当组织臂400被径向地部署时,其组织穿刺末端406刺穿结肠200的近侧部分201。参见图24和图25。一旦组织臂400被部署使得其组织穿刺末端406刺穿结肠200的近侧部分201,外科医生便可沿第二方向(用图17中的箭头313表示)使组织采集旋钮310旋转,从而将组织臂400运动至回缩位置。在组织臂400缩回时,它们使被刺穿的结肠200的近侧部分201聚集并将其向内朝组织采集轴380拉动。在聚集的结肠201在剪切板420与组织臂之间被拉动时,将被捕获在剪切板420的外边缘421与组织臂400上的切割边缘410之间的结肠200的部分201从结肠200的病变部分202切断。组织臂400的缩回使得结肠200的部分201被穿刺在组织保持销426上并被保留在其上,如图26所示。其后,可使用通过插入腹腔601的套管针套筒插入的常规腹腔镜式组织切断器械(未示出)将结肠200的病变部分202从远侧结肠部分208横切下来。在将病变部分202从远侧结肠部分208切掉后,可用常规抓持器械600通过套管针套筒(未示出)来移除病变部分202。参见图26。
然后,外科医生定向结肠200的远侧部分208内的砧170,使得砧轴474的砧轴联接杆476突出到结肠200的远侧部分208之外,如图28中所示。外科医生然后使用在本领域中称为“荷包缝合”220的方法将远侧结肠部分208的末端围绕砧轴474系扎。一旦将远侧结肠部分208围绕砧轴474系扎后,则将砧轴474的联接杆476插入砧轴组件450的通道452中。联接杆476的尺寸相对于通道152来设定以在它们之间建立摩擦配合,从而在其中保持联接杆176,但允许联接杆176在以后从其移除。参见图28。
外科医生然后通过沿合适的方向旋转砧控制旋钮460以朝缝合器头部420拉动砧470(沿近侧方向“PD”),直到结肠200的部分205、210被夹持在砧470与钉仓330之间,如图29所示。其后,外科医生启动击发触发器360以沿远侧方向“DD”使击发轴350轴向地行进。当击发轴350朝远侧行进时,缝钉驱动器部分354、356发挥作用以将缝钉36驱动穿过结肠200的部分205、210进入砧470中的砧成型袋472。击发轴350还使环形刀340行进穿过结肠部分205、210,以分别从结肠部分205、210切断部分201、207。外科医生然后可沿远侧方向“DD”使砧470运动,以从砧470与缝合器头部320之间释放缝合的结肠部分205、210。然后可将器械300从结肠200移除。参见图31。当外科医生将器械300通过患者的肛门撤离时,结肠200的切断部分201、207分别保留在缝合器头部320和砧470内。因此,当器械300从结肠撤离时,将结肠200的切断部分201、207从经修复的结肠移除。
圆形缝合器械通常通过肛门而不是从骨盆的腹腔侧引入。此类进入方法使外科医生观察肿瘤、肿瘤的必要边缘以及相对于远侧横切位置的那些边缘的能力复杂化,从而确保缝合器头部在开始横切之前已正确地定位在结肠中。图32-37示出了根据本发明的各种非限制性实施例的圆形缝合器700,其可在插入过程中向外科医生提供反馈。圆形缝合器700通常包括具有从其突出的细长轴组件714的柄部组件712。细长轴组件714可限定中心轴线A-A。如从图32中可看出,细长轴组件714包括具有支撑其上的缝合器头部720的远端部分的刚性外部护套716。在各种非限制性实施例中,缝合器头部720能够可操作地支撑其中的圆形钉仓730。此类圆形钉仓730是本领域已知的,并且通常可在其中支撑一排、两排或超过两排周向间隔和交错的缝钉。在图33中所示的非限制性实施例中,钉仓730在其中支撑两排732、734缝钉36。常规的环形刀740同轴地且可运动地被支撑在缝合器头部720内。
圆形缝合器700还包括被可操作地支撑在刚性外部护套716内以选择性地在其中轴向地运动的击发轴750。参见图33。击发轴750的远端部分752在其上具有外部缝钉驱动器部分754以与钉仓730中的缝钉36的外排732中的每颗缝钉36接合。此外,击发轴组件750的远端部分752还具有内部缝钉驱动器部分756,其能够与钉仓730中的缝钉36的内排734中的每颗缝钉36接合。如也可在图33中所见,例如,击发轴750的远端部分752还具有能够接合环形刀740的凸缘部分758。因此,如将在下文中进一步详细讨论,击发轴750沿远侧方向“DD”的轴向行进将使得缝钉36被驱动到钉仓730之外以及使得环形刀740朝远侧行进。
在多个非限制性实施例中,击发轴750与可操作地连接到柄部组件712的击发触发器60交接。如在图32中可见,击发触发器60可枢转地联接到柄部组件712,使得当击发触发器60朝柄部组件712枢转时,击发轴750沿远侧方向DD运动,如上文所讨论。
如图33中所示,多个非限制性实施例包括被同轴地支撑在击发轴750内并且可在其中轴向地运动的钩和检测外壳770。钩和检测外壳770在其中具有多个钩腔772,每个钩腔均在其中可运动地支撑采集钩构件780。如在图34中可见,例如,多个三面钩腔772可等间隔地围绕钩和检测外壳770的周围。例如,在图34中所示的非限制性实施例中,总共八(8)个钩腔772等间隔地围绕钩和检测外壳770的周围。每个钩构件780可由例如镍钛诺、300或400系列不锈钢(完全硬化或四分之三硬化的)等制成,并且具有当行进到其相应的钩腔772之外时,以上述方式向外自然挠曲或径向弯曲的远端部分782。与其它实施例一样,每个采集钩构件780可具有在其远端部分782上形成的组织倒钩784。如在图33和34中可见,在多个非限制性实施例中,钩和检测外壳770包括有助于采集钩构件780安装到它们相应的腔772内的钩套筒778。
在多个非限制性实施例中,钩和检测外壳770的近端部分可与被可操作地支撑在柄部712上的钩开关790可操作地交接。参见图32。当外科医生沿远侧方向(图32中的箭头792)使钩开关790运动时,钩和检测外壳770朝远侧运动。此外,每个采集钩构件780朝远侧行进到其相应的钩腔772之外,如上文所描述。外科医生可通过沿近侧方向(图32中的箭头794)使钩开关790运动而将钩构件780回缩到它们的起始位置。
多个柔性检测构件781也支撑在钩和检测外壳770内。具体地讲,多个检测腔774也提供在钩和检测外壳770中。例如,在图34中所示的非限制性实施例中,总共八(8)个检测腔774等间隔地围绕钩和检测外壳770的周围。在一个非限制性实施例中,每个检测构件781可由例如聚乙烯、尼龙、镍钛诺、钛等制成,并且当部署到其相应的检测腔774之外时具有向外自然挠曲或径向弯曲的远端部分783,如图35中所示。此外,基本上为钝的或圆形的缓冲器785可提供在每个检测构件781的远端上。在一个实施例中,缓冲器可由例如Sanoprene、聚异戊二烯、天然橡胶、聚丙烯、聚乙烯、尼龙等制成。在其它实施例中,缓冲器785可包括光源或发光二极管(LED)。在那些实施例中,导体可从柄部组件712中的电池或其它能源开始穿过检测构件781中的腔延伸至光源785。
在多个非限制性实施例中,每个检测构件770的近端部分可与被可操作地支撑在柄部组件712上的检测旋钮791交接。参见图32。在外科医生沿第一方向(图32中的箭头793)旋转检测旋钮791时,检测构件781沿远离中心轴线A-A的径向方向朝远侧部署至它们相应的腔之外的部署位置(图36)。在多个实施例中,例如所有检测构件781可附接到被可滑动地支撑在外部护套716内的圆形套筒(未示出)。圆形套筒还可具有连接到其上的齿条,所述齿条以与齿轮(未示出)啮接的方式被容纳在检测旋钮791的下侧上。检测旋钮791沿一个方向的旋转将套筒朝远侧运动,并因此使所有的检测构件781延伸。当外科医生将检测旋钮791沿第二方向(图32中的箭头795)旋转时,检测构件781被拉回到它们相应的检测腔774内并到达回缩位置。参见图34。在不脱离本发明的精神和范围的情况下,其它开关和驱动装置也可用于使检测构件选择性地延伸和回缩。
如在图33中还可看出,在多个非限制性实施例中,切割器外壳800同轴支撑在钩和检测外壳770内。切割器外壳800被支撑以用于相对于钩和检测外壳770选择性地轴向运动,并且沿中心轴线A-A选择性地轴向运动。切割器外壳800与被可运动地支撑在柄部组件712上的刀旋钮810交接。参见图32。在多个非限制性实施例中,刀旋钮810被支撑在柄部组件712上,使得其可轴向运动(在图32中以箭头812、814表示),还可相对于柄部组件712旋转(在图32中以箭头816表示)。切割器外壳800可按上述各种方式附接到刀旋钮810,使得刀旋钮810轴向地的运动在钩和检测外壳770内轴向地运动切割器外壳800,并且刀旋钮810的旋转还使切割器外壳800围绕中心轴线A-A旋转。
在多个非限制性实施例中,切割器外壳800包括轴向延伸穿过切割器外壳800的壁的多个刀腔802。如上文针对其它实施例所讨论,多个刀腔802可等间隔地围绕切割器外壳800的周围。例如,在非限制性实施例中,总共八(8)个刀腔802可等间隔地围绕切割器外壳800的周围。如在图33中可看出,每个刀腔802具有径向地向外打开的弯曲远端部分804。
在多个非限制性实施例中,柔性的刀构件820被可滑动地容纳在每个刀腔802内。每个柔性的刀构件820具有尖锐的远端822,以及与通过上述各种方式可操作地安装到柄部712的刀开关830交接的近端(未示出)。参见图32。远端822可为基本上尖的,以便使其能够刺穿组织,并且其可具有在其上形成的至少一个切割边缘。当刀开关830沿远侧方向(箭头832)运动时,刀构件820在刀腔802内朝远侧运动,使得尖锐的远端822自然挠曲或径向弯曲到腔802的弯曲远端部分804之外,如上文所描述。同样,刀开关830沿近侧方向(在图32中以箭头834表示)的运动使刀构件820回缩到它们相应的刀腔802内。在多个非限制性实施例中,刀构件820可由例如镍钛诺、300或400系列不锈钢(完全硬化或四分之三硬化的)制成。
如在图33中也可看出,多个非限制性实施例还可包括同轴支撑在切割器外壳800内用于在其中选择性地轴向运动的砧轴组件840。砧轴组件840可包括从击发轴750的一部分突出的远端柱842。远端柱842在其中支撑从远端柱842朝远侧突出的远侧砧连接器850。砧轴组件840具有与可旋转地支撑在柄部组件712上的调节旋钮760交接的近端部分,如上文针对其它非限制性实施例所讨论。圆形缝合器700还包括如图32所示的砧170。
现在将描述使用圆形缝合器700的一个示例性方法。外科医生将细长轴714通过患者的肛门199插入结肠200的近侧部分201,从而开始手术。其后,外科医生可如图36和37中所示使检测构件781延伸,以便“微调”缝合器头部720的定位。这可通过沿适当的方向旋转检测旋钮791来实现。在缓冲器785被径向推入结肠部分201的壁内时,它们形成可辨认的隆起或偏转203或向外突出的不规则区域,并且为外科医生提供可视观察缝合器头部720所处位置的方式。此类可辨认特征不同于结肠壁的实际解剖结构。基本上为钝的或圆形的缓冲器不刺穿或破坏结肠壁。此类缓冲器203允许外科医生将缝合器头部720相对于结肠的肿瘤或患病部位202定位。如果一个或多个缓冲器785包括光源,则外科医生可如图37中所示观察通过结肠壁的光。
一旦外科医生将缝合器头部720定位在结肠200近侧部分201内的所需位置,外科医生就可通过将检测旋钮791沿与其中造成检测构件781延伸的方向相对的方向旋转来将检测构件781回缩到钩和检测外壳770内。然后,采集钩构件780可被延伸,从而刺穿并且采集近侧结肠壁201的相邻部分。然而,在可供选择的实施例中,外科医生可选择将检测构件781保持在它们的延伸位置,如图37中所示。在这种情况下,检测构件781可以在结肠壁中产生一些“环向应力”,其可以通过采集钩构件780帮助采集并刺穿近侧结肠壁201。
要使采集钩780接合并刺穿近侧结肠部分201,外科医生需通过沿远侧方向(图32中的箭头792)运动钩开关790而使钩和检测外壳770朝远侧行进。钩和检测外壳770沿远侧方向的运动使采集钩构件780从它们的相应钩腔772轴向地移出。在采集钩构件780的远端从它们的相应钩腔772退出时,它们向外径向地运动以接合并刺穿近侧结肠壁201的相邻部分。参见图37。一旦钩构件780刺穿并接合近侧结肠壁201的相邻部分,外科医生便沿近侧方向(在图32中以箭头794表示)使钩开关790运动,从而将采集钩构件780回缩到它们的相应钩腔772,并将钩和检测外壳770回缩到其起始位置。采集钩构件780远侧末端上的倒钩784将近侧结肠壁201的接合部分拉入与图9中示出位置类似的位置。一旦近侧结肠部分201的部分被拉入图9中示出的位置,外科医生便可通过执行上文针对圆形缝合器10所述的相同操作来完成手术。
图38示出了根据本发明的多个非限制性实施例的另一种圆形缝合器900。圆形缝合器900通常包括具有从其突出的细长轴914的柄部组件912。细长轴914可限定中心轴线A-A。如从图38中可看出,细长轴914包括具有位于其远端917的缝合器头部920的刚性外部护套916。在各种非限制性实施例中,缝合器头部920能够可操作地支撑其中的圆形钉仓930。此类圆形钉仓930是本领域已知的,并且通常可在其中支撑一排、两排或超过两排周向间隔和交错的缝钉36,如本文上面所述。常规的环形刀940同轴地且可运动地支撑在缝合器头部920内。参见图39。
圆形缝合器900还包括支撑在刚性外部护套916内以选择性地在其中轴向运动的击发轴950。参见图39。击发轴950的远端部分952在其上具有外部缝钉驱动器部分954以与钉仓930内缝钉36的外排32中的每颗缝钉36接合。此外,击发轴950的远端部分952还具有内部缝钉驱动器部分956,其能够与钉仓930内缝钉36的内排34中的每颗缝钉36接合。如也可在图39中所见,例如,击发轴组件950的远端部分952还具有能够接合环形刀940的凸缘部分958。因此,如将在下文中进一步详细讨论,击发轴950沿远侧方向“DD”的轴向地行进将使得缝钉36被驱动到钉仓930之外以及使得环形刀940朝远侧行进。
在多个非限制性实施例中,击发轴950可与被可操作地连接到柄部组件912的击发触发器960交接。参见图38。如在图38中可见,击发触发器960可枢转地联接到柄部组件912,使得当击发触发器960朝柄部组件912枢转时,击发轴950沿远侧方向DD运动。如上所讨论,此类击发触发器装置在本领域中是已知的,并因此将不在本文详细讨论。
如图39所示,多个非限制性实施例还可包括被同轴地支撑在中空组织采集轴980内的中空部署轴970。部署轴970的近端可操作地附接到臂部署旋钮910,其以上述多种方式被可旋转地支撑在柄部组件912上。因此,臂部署旋钮910在柄部组件912上的旋转将使得部署轴970围绕中心轴线A-A旋转。更具体地讲并参照图40,在多个实施例中,部署轴970的远端972突入组织采集轴980的孔982并具有附接到其上的驱动齿轮974。组织采集轴980的远端984能够可操作地在其上支撑至少一个组织采集构件或臂1000。两个或更多个组织臂1000是优选的。在图40所示的非限制性实施例中,总共4个组织臂1000通过相应的销986可枢转地插到组织采集轴980的远端984。
每个组织臂1000可具有可由例如不锈钢(300或400系列)、钛、钛-钢复合材料、陶瓷等制成的主体部分1002并具有连接到其上或在其上形成的从动齿轮1004。每个组织臂1000的从动齿轮1004被可运动地支撑在组织采集轴980的远端984中形成的相应臂腔988内。每个从动齿轮1004与部署轴970上的驱动齿轮974啮接。因此,部署轴970的旋转将使得组织臂1000从图41所示的回缩位置枢转式部署到图42所示的部署位置。在多个实施例中,每个组织臂1000的主体部分1002可进一步具有在其上形成的或以其它方式附接到其上的组织穿刺末端1006。
在多个实施例中,刀轴1010被同轴地容纳在部署轴970内并与可旋转地支撑在柄部组件912上的刀旋钮1020(图38)交接,使得刀旋钮1020的旋转使得刀轴1010的旋转。刀轴1010还具有突出到部署轴970和组织采集轴980各自的远端972、984之外的远端1012。参见图40。刀1030通过例如销1032或其它合适的紧固件可拆卸地连接到刀轴1010的远端1012。在多个实施例中,刀1030可为基本上平坦的,并具有在其上形成的直径相对的组织穿刺点1031、1033,如图40所示。
还可如在图39中所见,多个非限制性实施例还可包括砧轴组件440,其包括从击发轴950的一部分突出的远端柱442,击发构件在部署轴970内同轴延伸以在其中选择性地轴向运动。远端柱442在其中支撑连接到调节旋钮460的远侧砧连接器450,而调节旋钮则以上述多种方式被可旋转地支撑在柄部组件312上。
圆形缝合器900还包括如图39所示的砧470。在多个非限制性实施例中,砧470包括在其中具有一系列缝钉成型袋472的砧基座471。砧基座471还可限定剪切边缘473以有利于通过环形刀940剪切组织。砧470还可包括可拆卸地连接到远侧砧连接器450的砧轴474。具体地讲,联接杆476从砧轴474的近端475突出,并且尺寸设定成可滑动地容纳在砧轴组件450的通道452中。砧470在其上还可具有用于在其中限定组织腔体479的砧盖478,如图39所示。
将参照图39和图43-51描述使用圆形缝合器900的一个示例性方法。首先转到图39,将缝合器头部920通过患者肛门199插入管状器官,例如结肠200。使缝合器头部920位于邻近病变部分202的结肠200的近侧部分201中。其后,通过沿第一方向(由图38中的箭头911表示)旋转臂部署旋钮910(同时也旋转部署轴970)而径向地部署组织臂1000。部署轴970沿第一方向的旋转也使与每个组织臂1000的从动齿轮部分1004啮接的驱动齿轮974旋转。因此,驱动齿轮974沿第一方向的旋转使得组织臂1000被径向地部署。当组织臂1000被径向地部署时,其组织穿刺末端1006刺穿结肠200的近侧部分201。参见图44和图45。外科医生然后可沿相对的方向或第二方向(由图38中的箭头913表示)旋转臂部署旋钮910,以将组织臂1000缩回至其回缩位置(图20)。当组织臂1000被缩回时,结肠200的被刺穿的近侧部分201由组织臂1000携带,使得部分201聚集在组织臂1000与邻近钉仓930处于面对位置的臂轴980之间。其后,外科医生可旋转刀旋钮1020以使刀1030旋转并从结肠201的近侧部分切断结肠200的病变部分202。可使用被插入定位在腹腔601中的套管针套筒(未示出)的常规腹腔镜式组织切断器械(未示出),从结肠的远侧部分208横切病变部分202。在将病变部分202从结肠200的近侧部分201和远侧部分208切掉后,可将病变部分202通过常规抓持器械600穿过套管针套筒移除。参见图48。
外科医生然后可在结肠200的远侧部分208内定向砧470,使得砧轴474的砧轴联接杆476突出到结肠200的远侧部分208之外,如图49所示。外科医生然后可使用在本领域称为“荷包缝合”220的方法将远侧结肠部分208的末端围绕砧轴474系扎。一旦将远侧结肠部分208围绕砧轴474系扎后,则将砧轴474的联接杆476插入砧轴组件450的通道452内。联接杆476的尺寸可相对于通道452来设定以在它们之间建立摩擦配合,从而在其中保持联接杆476,但允许联接杆476在以后从其移除。参见图49。
外科医生然后通过沿合适的方向旋转砧控制旋钮460以朝缝合器头部920拉动砧470(沿近侧方向“PD”),直到结肠200的部分205、210被夹持在砧470与钉仓930之间,如图50所示。其后,外科医生启动击发触发器960以沿远侧方向“DD”使击发轴950轴向地行进。当击发轴950朝远侧行进时,缝钉驱动器部分954发挥作用以将缝钉36驱动穿过结肠200的部分205、210进入砧471中的砧成型袋472。击发轴950还使环形刀940行进以分别从结肠部分205、210切断结肠部分201、207。外科医生然后可沿远侧方向“DD”使砧470运动,以从砧470与缝合器头部920之间释放缝合的结肠部分205、210。然后可将器械900从结肠200移除。参见图51。切断的部分207被捕获在砧腔479中,而切断的部分201则被保持在组织臂1000与臂轴980之间。因此,当将器械900从结肠撤回时,将结肠200的切断部分201、207从经修复的结肠移除。
当外科医生在身体的该区域中执行上述手术或其它相关手术时,必须格外小心以避免无意中损伤相邻的软组织和骨骼结构。图52和图53示出了邻近结肠200的一些相邻组织和骨骼结构。在图52中,腹膜1100已被切开以示出例如肛门括约肌1101、骶结节韧带1102、坐骨结节1104、坐骨肛门窝1106、肛提肌1108和第三骶椎1110。图53还示出了直肠旁窝1112、骶骨生殖皱襞(sacrogenitalfold)1114、尿管1116、输精管1118、膀胱1120、膀胱旁窝1122和膀胱皱襞(transvesicalfold)1124。外科医生当触及待切除的结肠200的部分时还必须小心不要损伤沿腹膜1100内壁的肌肉、神经、血管和动脉。
图54-57示出了使用本发明的非限制性实施例的保护护套1200。在多个实施例中,护套1200可由例如Kevlar、聚乙烯、尼龙等制成并以使其自然卷曲的方式承受张力。参见图55。在多个实施例中,可在护套1200上提供测量或参考标记1202,以帮助外科医生定位外科器械的可操作部分(例如,圆形缝合器的缝合器头部)以及防止意外损伤相邻的神经、血管和组织。在其它实施例中,护套1200可由磁敏膜制成,这将使得其能够以磁力吸引到器械的可操作部分,以使相邻的解剖结构和组织免受例如可能损伤相邻组织、肌肉、骨骼、神经等的器械部分在与其无意中接触时产生的影响。在另外的可供选择的实施例中,护套1200可具有被吸引到缝合器头部的磁相互作用环或部分。因此,护套1200的至少一部分可为有磁性的或以其它方式具有附接到其上的磁性材料。
护套1200可通过以腹腔镜插过腹壁进入腹腔的常规套管针1250的插管1252而安装,如图54中所示。常规腹腔镜抓持器械600可如图54和图55所示用于从套管针插管1252移除护套1200。其后,外科医生可使用常规抓持器械600将部署的护套1200围绕结肠200卷绕,如图56所示。图57示出了围绕结肠200卷绕之后以及开始将圆形缝合器械插入结肠之前的护套1200。护套的自然卷曲性质起到将其保持在围绕结肠200的卷曲取向的作用。
本发明的护套1200可有效地用于在使用任何上述实施例的过程中保护相邻的组织和器官。参见例如图5-16、23-31、36、39和43-51,其中护套1200已按上述方式围绕结肠200安装。此外,护套1200的非限制性实施例可有效地结合常规圆形缝合器械等使用而不脱离本发明的精神和范围。对于采用检测构件等上的光源的那些器械实施例,护套1200可由例如光敏膜制成,这将使得护套1200的部分在邻近发光检测构件的那些区域中改变颜色。参见例如图36中所示的非限制性实施例。
本发明的多个实施例代表了现有圆形缝钉构造和与之相关的手术的巨大进步。虽然已经描述了本发明的多个实施例,但显而易见的是,掌握了本发明的一些或全部优点的本领域的技术人员可能会想到这些实施例的各种修改、变型和变通形式。例如,根据多个实施例,单个部件可替换为多个部件,并且多个部件也可替换为单个部件,以执行给定的一种或多种功能。因此,在不脱离所附权利要求书限定的已公开发明的范围和精神的情况下,本专利申请旨在涵盖所有此类修改、变型和变通形式。
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发明所述的现有定义、陈述或其它公开材料相冲突的范围内并入本文。由此,在必要的程度下,本文所明确阐述的公开内容将取代以引用方式并入本文的任何相冲突材料。如果据述以引用方式并入本文但与本文所述的现有定义、陈述或其它公开材料相冲突的任何材料或其部分,仅在所并入的材料和现有的公开材料之间不产生冲突的程度下并入本文。
旨在受到保护的本发明不应被理解为受所公开的具体实施例的限制。因此应将这些实施例看作是示例性的而非限制性的。在不脱离本发明精神的情况下,其他人可以进行更改和修改。因此,需要明确指出的是,本发明应涵盖落入权利要求书所限定的本发明的精神和范围内的所有这些等同形式、变型形式和修改。

Claims (16)

1.一种外科器械,包括:
细长轴,所述细长轴限定中心轴线并且具有远端部分,所述远端部分能够可操作地支撑其中的圆形钉仓;
被可操作地支撑在所述细长轴内的至少一个采集构件,每个所述采集构件均具有组织穿刺远侧部分,在向所述采集构件施加展开运动时,所述组织穿刺远侧部分能够远离所述中心轴线径向地展开;
被可运动地支撑在所述细长轴中的至少一个柔性的刀构件,每个所述刀构件均具有远侧切割部分,在向所述刀构件施加轴向致动运动时,所述远侧切割部分能够轴向地行进到所述细长轴的所述远端部分之外,在向所述刀构件施加旋转致动运动时,每个所述刀构件均能够围绕所述中心轴线选择性地旋转;
被可操作地支撑在所述细长轴内的至少一个检测构件,每个检测构件均具有远侧部分,在向所述检测构件施加展开运动时,所述远侧部分能够远离所述中心轴线径向地展开;以及
在所述检测构件的所述远侧部分上的光源。
2.根据权利要求1所述的外科器械,其中每个所述检测构件均被可运动地支撑在检测和采集外壳中,所述检测和采集外壳被可运动地支撑在所述细长轴内。
3.根据权利要求2所述的外科器械,其中当每个所述检测构件的所述远侧部分轴向地行进到所述检测和采集外壳的远端之外时,所述远侧部分自然地径向弯离所述中心轴线。
4.根据权利要求1所述的外科器械,还包括在每个所述采集构件的所述组织穿刺远侧部分上的组织穿刺倒钩。
5.根据权利要求1所述的外科器械,其中每个所述刀构件均具有在其上形成的组织穿刺点。
6.根据权利要求1所述的外科器械,还包括环形切割构件,所述环形切割构件由所述细长轴的所述远端支撑以用于相对于所述细长轴的所述远端选择性地轴向行进。
7.根据权利要求6所述的外科器械,其中所述环形切割构件被支撑以从被可操作地支撑在所述细长轴中的击发构件接收轴向击发运动。
8.根据权利要求1所述的外科器械,其中所述至少一个采集构件包括多个采集构件。
9.根据权利要求1所述的外科器械,其中所述至少一个刀构件包括多个刀构件。
10.一种外科器械,包括:
细长轴,所述细长轴限定中心轴线并且具有远端部分,所述远端部分能够可操作地支撑其中的圆形钉仓;
被可操作地支撑在所述细长轴内的多个检测构件,每个检测构件均具有远侧部分,以及与可操作地支撑在所述细长轴上的致动器可操作交接的近侧部分,使得在向所述致动器施加致动运动时,所述多个检测构件的所述远侧部分能够远离所述中心轴线同时径向地展开;以及
被可操作地支撑在所述细长轴内的至少一个采集构件,每个所述采集构件均具有组织穿刺远侧部分,在向所述采集构件施加展开运动时,所述组织穿刺远侧部分能够远离所述中心轴线径向地展开。
11.根据权利要求10所述的外科器械,还包括被可运动地支撑在所述细长轴中的至少一个柔性的刀构件,每个所述刀构件均具有远侧切割部分,在向所述刀构件施加轴向致动运动时,所述远侧切割部分能够轴向地行进到所述细长轴的所述远端部分之外,在向所述刀构件施加旋转致动运动时,每个所述刀构件均能够围绕所述中心轴线选择性地旋转。
12.根据权利要求10所述的外科器械,其中每个所述检测构件均具有钝的远端部分。
13.根据权利要求11所述的外科器械,还包括在所述检测构件的所述远侧部分上的光源。
14.一种外科器械,包括:
细长轴,所述细长轴限定中心轴线并且具有远端部分,所述远端部分能够可操作地支撑其中的圆形钉仓;
被可操作地支撑在所述细长轴内的至少一个检测构件,每个检测构件均具有远侧部分,在向所述检测构件施加展开运动时,所述远侧部分能够远离所述中心轴线径向地展开;以及
被可运动地支撑在所述细长轴中的至少一个柔性的刀构件,每个所述刀构件均具有远侧切割部分,在向所述刀构件施加轴向致动运动时,所述远侧切割部分能够轴向地行进到所述细长轴的所述远端部分之外,在向所述刀构件施加旋转致动运动时,每个所述刀构件均能够围绕所述中心轴线选择性地旋转。
15.根据权利要求14所述的外科器械,其中每个所述检测构件均具有钝的远端部分。
16.根据权利要求14所述的外科器械,还包括在所述检测构件的所述远侧部分上的光源。
CN201180037357.1A 2010-07-30 2011-07-27 用于外科圆形缝合器的透过壁可视化装置 Active CN103052361B (zh)

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