CN103006283A - 外科手术钉合器 - Google Patents
外科手术钉合器 Download PDFInfo
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
- A61B17/0682—Surgical staplers, e.g. containing multiple staples or clamps for applying U-shaped staples or clamps, e.g. without a forming anvil
- A61B17/0684—Surgical 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 above the tissue during stapling
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- A61B17/064—Surgical staples, i.e. penetrating the tissue
- A61B17/0644—Surgical staples, i.e. penetrating the tissue penetrating the tissue, deformable to closed position
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- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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Abstract
一种外科手术钉合器,用在开放式疝气修补过程中,其包括细长轴,在细长轴的近端具有手柄(120),并且在细长轴的远端具有向下设置的钉合钉排出头(130)。手柄(120)上的挤压触发器(122)可被操作以使供应的钉合钉(160)选择性地从上述端口射出。一个或多个补片操纵器(150)设置于头(130)上并在用钉合钉固定之前用来帮助定位或者在其他情况下操作外科手术补片。
Description
相关申请交叉参考
本申请为申请日为2009年3月13日、申请号200980108633.1、发明名称为“具有集成的补片操纵器的疝气钉合器”的中国发明专利申请(对应的PCT申请号为PCT/US2009/037119)的分案申请。
技术领域
本申请总体上涉及用于应用外科手术钉合钉(staple)来扎牢外科手术补片(mesh,补网)的装置。更特别地,但非专门地,本申请涉及一种外科钉合器,其具有用于在应用钉合钉之前定位外科手术补片的远端操纵器。
背景技术
由Robert J.Fitzgibbons和A.Gerson Greenburg编辑,LippincootWilliams & Wilkins,Philadelphia,2002年出版的Nyhus and Condon’s Hernia的第五版149-268页,第14章,“The Transabdominal PreperitonealLaparoscopic Herniorrhaphy”,描述了用以修补腹股沟疝气的一些步骤。其中提到了一层单丝聚丙烯补片作为适于在此类步骤中使用的材料。在修补位置对补片进行成形和定位之后,它被缝合到邻近的组织。
虽然缝合是一种长期存在的固定补片的做法,但钉补法由于速度和操作起来相对容易的原因被经常采用。在一些需要将补片连接到组织的部位,钉补法是可行的,但在一些其他需要连接的部位,仅凭一双手将补片保持并钉补到组织上即使不是不可能,也可能是富有挑战性的。改进是需要的。
发明内容
本发明提供了例如在进行腹股沟疝修补时,应用外科钉合钉并使用钉合钉来保持外科手术补片的系统和技术。这些系统和技术也可被应用于腹疝/切口疝修补,用于皮肤闭合或者用于技术人员会遇到的其他外科手术过程。尽管此处所涵盖的本发明的实际特征仅能够根据所附权利要求来确定,但是将在下面简要描述以本文所公开的实施例为特征的本发明的某些方面。
根据一方面,一种改进的用以连接外科手术补片的外科钉合器包括细长轴,在细长轴的近端(proximal end)具有手柄,并且在细长轴的远端(distal end)具有向下设置的钉合钉排出端口(discharge port,发射端口)。手柄包括一个触发器,该触发器被构造为使供应的钉合钉被选择性地从排出端口排出(discharge,射出)。一个或多个补片操纵器靠近排出端口设置并可操作以便在发射钉合钉将补片固定到组织之前帮助外科手术补片定位。补片操纵器可以固定在适当位置或做成可伸缩的(retractable)。在一个特殊方面,补片操纵器是细长轴的形式,该细长轴选择性地从安装于细长轴下方的壳体延伸。在另一特殊方面,补片操纵器包括安装于排出端口的相对布置侧上的多个尖头(prong,叉头、突头)。
根据另一方面,一种新型外科钉合器包括细长轴,在细长轴的近端具有手柄,在细长轴的远端具有向下设置的排出头(discharge head),该外科钉合器还包括安装于排出头与上述轴之间的有角度的钉合钉仓(magazine of staples)。排出头中的钉合钉成形器经由延伸通过上述轴的致动件由手柄中的触发器驱动。致动件可以包含位于轴的直段中的刚性杆和跨越轴的弯曲段的柔性件。
这些和其他方面在以下进行论述。
附图说明
图1是本发明的一个实施例的侧视图。
图1A是钉合器头的一部分的局部放大图,示出了从钉合钉出口端口(exit port)伸出的钉合钉并且示出了补片定位探测金属丝(probe wire)的末端。
图2是钉合器的前视图。
图2A是钉合器头部的局部放大前视图。
图3是钉合器头部的局部放大示意图,其中钉合器头部是前弯探测金属丝型的,以将补片推进至身体组织上的期望位置以便钉合。
图3A图示了金属丝向前推进一片补片的实际应用。
图4是类似于图3的视图,但示出了探测金属丝末端部分向后成角度以拉动补片。
图4A类似于图3A,但示出了图4的的末端接合以拉动补片。
图5是成形用来定位在修补位置的一片补片的示意图,并图示了需要钉合的位置。
图6是修补位置的示意图,其中钉合器头位于开口中。
图7是修补位置的示意图,其中钉合器就位以在开口远侧将补片钉合到身体组织下侧。
图8A是安装之前的钉合钉的视图。
图8B、8C、8D和8E代表钉合钉钉合之后的四种可能的不同构型,这些形状取决于针对钉合器头中的结合所规定的钉合钉形成特征。
图9是在图7中箭头9-9方向上观察的所述位置的示意图。
图10是新型结构钉合器的侧视图。
图11是图10钉合器的分解图,为了清晰省去了手柄的第二半部。
图12是图10钉合器的钉合钉排出头(discharge head)的底视图,为了清晰省去了用于钉合钉的前壁件152和支撑仓140。
图13是图13的底视图,其中钉合钉部分成形。
图14A是从图10中的箭头14-14的方向上观察的图10钉合器的排出头部的端视图。
图14B至图14D是排出头上的尖头的可选布置的视图。
具体实施方式
参照图1-图2A,钉合器11具有手柄12,该手柄带有在14处可枢转地安装至手柄的触发器13。管16固定于手柄并且在它的远端具有钉合器头部17。该头部从轴线18向下弯大约四十度的角度(图1中的A)并且具有钉合钉排出端口19,钉合钉通过该钉合钉排出端口被射出,每拉动一下触发器便发射出一个钉合钉。耦接于钉合钉发射器的触发器是一种二阶系统,从而钉合钉21可从头部中被推进至图1和图1A所示的位置。然后,当进一步拉动触发器时,钉合钉就可被射出并穿过补片进入组织。
一个创新性特征是在钉合器的出口端口附近设置有补片操纵器(meshmanipulator)。正如在此所应用的,“补片操纵器”不包括钉合钉本身,而是一种除钉合钉以外的结构,其可被操作以用来操纵外科手术补片。在图1和图1A中,补片操纵器包括细长件或金属丝22,该细长件或金属丝具有包括末端23的远端部分,该末端在平面25(图2A)中并在头部17的下面向下伸出,上述平面25包含管16的轴线18并将手柄12一分为二。此细长件从末端部分向后延伸通过管16底部的通道24。设置在上述通道上可滑动并连接至金属丝近端的金属丝控制按钮26,以使金属丝向前滑动,进而使末端23延伸至钉合钉出口端口19下方更远处,或者当外科医生期望时将金属丝缩回至通道24内并且缩回至外科医生期望的程度。当使用者需要时,可采用金属丝控制旋钮或按钮的其他位置。一个例子是位于手柄自身内。
为了有效的补片操纵的目的,金属丝22可能经常,但不总是,被定位成使得末端23伸出超过由出口端口19限定的平面40几毫米,如图1A所示。例如,期望当末端23距离平面40至少大约2mm、3mm、4mm、5mm、6mm、7mm、8mm、9mm或10mm远时可实现有效的补片操纵。
现在参照图3和图3A,金属丝27设置有向下并向前弯曲的弯曲末端部分28,以便插入穿过补片29并在箭头31的方向上将补片向前推进,以将补片移动至钉合所需的位置。此向前运动可以通过使用手柄移动钉合器本身或者通过移动滑动按钮26来移动金属丝而实现。
参照图4和图4A,金属丝32具有向后弯曲的末端部分33,以使金属丝末端能够穿过补片29并在箭头34的方向上将补片向后拉,进而将补片定位在期望的位置处,即相对于期望穿过补片钉合至组织的位置处。
现在参照图5,这里示意性地示出了补片29,其从一大片切割成放置在外科手术位置所需的形状。示出了在补片边缘处的11个位置,其表明了需要从边缘向内侧进行钉合的位置。这是一个示例,可以根据位置的需要而选择不同尺寸和形状以及数量的钉合钉。
图6是钉合钉头插入到开口36内的位置的示意图。在本文中将最靠近外科医生的开口边缘37称为近边,而相对边缘38指远边。在近边37下面通过钉合将补片连接至组织可在钉合器如图6所示那样定向的条件下相对地直线向前,但是向外拉动以将上述头放置在近边37处,并将头向下移动至补片,进而在尖头进入下面的组织中的条件下将钉合钉向下射入补片中。在相对边缘上,将补片钉合至组织的上部内侧面。利用传统仪器这将极其困难。但本发明能够如图7和9所示的那样翻转,以使排出端口19和金属丝23向上面对组织并通过如图3或图4所示的金属丝末端被推动或拉动(这取决于将补片推动或拉动至钉合所需的位置的最有效的方法),然后在尖头通过补片并进入反转或上层组织的条件下向上射出钉合钉。
在图1中,例如并不加限制,头部17具有所示的向下成角度A的排出端口。作为示例,此角度相对于轴的中心线18可以在30至50度之间。45度可能是最佳的。
头的底部和轴的顶部之间的总偏移B优选地在12至25毫米之间。如果特殊的外科手术位置需要或必需,也可以采用其他角度和偏移尺寸。例如,头与轴16进入手柄12处的近端之间的总长度可以是85毫米。再次,可根据外科医生的偏好和外科手术位置的特性来确定其他的尺寸。对于手柄的形状和特征同样如此,图10至图11中示出了将被描述的一个不同形状的示例。例如,钉合钉的尖头之间的宽度可以是5毫米,但可以针对特殊情况选择其他宽度的钉合钉。例如,用0.5mm的钉丝来生产完全成形的盒钉(box staple),其中成形的钉合钉具有大约7.5mm的宽度和大约3.5mm的高度。在一些工具中,使轴在手柄中可旋转和/或在轴中靠近其进入手柄处提供关节连接可能被认为是理想的,但是现在,看上去简单地将手柄从图1所示的姿势翻转到图7和9所示的姿势就显得足够了。用于发射钉合钉的各种机构都可实施。例如,US 5,829,662和US 5,743,456描述了可用来实施本发明的内窥镜钉合装置。
现在参照图10至图14A,钉合器100包括位于细长轴110的两端处的手柄单元120和向下设置的排出头130。包含供应的钉合钉(例如15个)的钉仓140安装于轴110的下面。操作触发器122以使钉合钉160成形并从头130的出口端口162发射。触发器的连续拉动成形钉合钉进而从钉仓140中射出连续的钉合钉,并且钉的连续计数显示在170处的窗口中。
钉合钉的成形和射出通过推板116的单次行程完成,该推板通过延伸穿过轴130的机械联动装置与触发器112耦接。更具体地,驱动块125安装在壳体123的狭槽中,其中压缩弹簧127的一端在舌片126上方并且另一端顶着舌片124。驱动块125耦接至驱动器113或者刚性条,其可滑动地设置在轴110的上盖111与底座114之间限定的通道中。还在轴通道中设置加强杆112以增大轴110的细长直段部分的结构刚度。柔性推动件115耦接至驱动器113的端部并横穿通道的弯曲部分,该弯曲部分包括在上盖111中用于柔性推动件115的支撑肋以降低柔性推动件115弯曲(buckle,屈服/挠曲)或其他变形的可能性。推板116被层压至柔性推动件115的远端以形成无缝连接。其他连接也是可行的。
在操作中,挤压触发器112来驱动块125至右侧(图10、11),克服弹簧127、128的回复力。弹簧127和128每一个均起到复位弹簧的作用,因此提供了过剩,但它们的弹簧系数可选择成产生期望的效果(例如,在最大触发器受压时实质性地增大的回复力)。当块125向右侧行进时,单向离合组件129接合块125下侧的嵌齿(cog)(未示出),以防止块125不足满行程时就缩回。另外,穿梭板176承载在块125上方并操作以推进编号带172,该编号带夹在穿梭板176与驻留板174之间并通过邻近垫板(backing plate)170的窗口提供钉合钉的连续计数。
在行程的开始,推板116撤回到排出头130内,并且钉仓140中的第一个钉合钉被推进发射膛。如图12和13所示,钉仓140中的钉合钉为有角度的叠堆的形式,叠堆中的每一个钉合钉160都在它的发射方向上定向(也就是说,平行于膛的后壁132)并且叠堆的轴线偏离正交于发射方向的方向40-50o。
如图所示,钉合钉仓中的钉合钉通常为“M”形并且安装于支架144的前导轨之上,导轨的其中之一上都有各自的峰。盖板143固定于支架144的顶部并且弹簧推动件145朝向支架144的开放的、成角度的端部偏压钉合钉叠堆160。如图所示,弹簧偏压推动件145具有的未压缩长度比钉合钉叠堆的长度更长,这在射出钉合钉时能用来在钉合钉叠堆上提供更持续的力。导引器146定位在支架144的开放端部处并提供带角度的指状物,该指状物防止钉合钉从成角度的开放端部过早地掉出。钉仓140安装于底座114上的支撑导轨并被防护罩142盖住,并且前壁件152被固定以完成组件。
随着推板在其行程中的推进,推板116的成形指状物135从叠堆中挑出第一个钉合钉并使该钉合钉在砧座133周围成形。图13示出了从出口端口162延伸的已部分成形的钉合钉。成形指状物135则继续用来使钉合钉完全成形为所需的盒形形状,并且优选地使钉合钉尖头稍向后反转。成形指状物135的缩回释放已被放置在下行行程中的片簧134,这用来将现已成形的钉合钉从砧板133处移走。因为成形的钉合钉更窄,所以它很容易滑过出口端口162的较宽的中央开口,如图14A至图14D所示。
如图所示,钉合器100包括位于出口端口162外侧的下侧的固定突头(prong)150。突头150起到补片操纵器的作用并且这里可以以考虑到任何方式使用。图14B至图14D提供了钉合钉排出端口附近的补片操纵图头的附加或替换位置的图示。固定突头也可与可缩回的金属丝结合使用以提供操纵能力的其他组合。还可以考虑钉合器100能在没有任何用于补片操纵的装置的情况下使用。
可使用此处所述钉合器的多种变型。例如,沿着所描述的钉合器的轴提供一个或多个关节点可能是理想的。作为一例,能够90o关节活动的关节连接接头可沿着轴110,例如靠近轴110和手柄120的会合处。提供的此类关节连接接头可以使惯用右手的外科医生在进行右侧腹股沟疝手术时更加容易放置将补片连接至腹股沟韧带的钉合钉。
此处所用钉合钉是可吸收的或不可吸收的,通过在可吸收材料内部的材料来形成钉合钉。方形、圆形、G形等等。钉合钉可沿轴内部的架子(该架子利用弹簧负载作用将钉合钉引导至轴的远端)或者手柄内的机构而堆叠在一起。
过程
在全身麻醉或者采用镇静剂的情况下进行局部麻醉的条件下,对下腹部进行术前准备并遮盖。沿自然皮肤褶皱切出6到8cm的线性皮肤切口。进行止血。外部倾斜腱膜被分开,露出精索。根据疝气类型,将疝囊从毗邻组织剖离,清空其中任何容留物并将其推回腹膜腔内。待使用的补片被切割成标准形状和尺寸,并且尾端开口被安排用来容纳精索。然后使用钉合器将补片固定至直肌鞘的附着处(insertion)并且沿着腹股沟韧带。(钉合器的尺寸和形状形成为确保股骨血管和神经的安全。)补片的上边缘被钉合至直肌鞘和内部倾斜腱膜以避开髂腹下神经(iliohypogastric nerve)。然后将钉合钉或者单独的不可吸收的缝合线穿过内环高度处的尾部的下边缘。随后,在所有出血已止住并且器械和棉球数目正确之后逐层闭合伤口。伤口可以利用钉合器或者传统缝合线来闭合。
应了解到所描述的内容包括一种改进的用以连接外科手术补片的外科手术钉合器,其包括:细长轴,细长轴的近端具有手柄,并且细长轴的远端具有向下设置的钉合钉排出端口,其中手柄可被操作以使供应的钉合钉选择性地从上述端口射出;以及一个或多个补片操纵器,其靠近端口并且伸出而远离端口所限定的平面。
所描述的内容还包括一种被人用来将补片钉合至在腹股沟疝外科手术位置处的身体组织的器械,该器械包括:手柄,用于保持器械邻近外科手术位置,并具有近端和远端;轴,限定了纵向轴线,并具有近端和远端,并且该近端安装于手柄的远端;钉合钉排出头,一端具有连接至轴的远端的安装部分,并且另一端具有钉合钉出口端口;该头适于将钉合钉从所述头、通过所述端口且沿一直线并沿远离手柄的方向发射出,其中钉合钉的发射方向相对于轴的纵向轴线向下;细长件,安装于所述轴并且大体平行于该轴且在向前远离所述手柄的方向上延伸,该细长件具有在包含钉合钉发射方向的平面内的远端部分,并且所述细长件的远端部分与所述线间隔开并在此线下面;并且所述细长件的远端部分具有被构造为在腹股沟疝外科手术中与有益于嵌入体腔中的补片接合的末端,以便连接并且移动所述补片至将该补片钉合至外科手术位置处的身体组织的位置。在一项改进中,所述细长件的远端部分是狭窄的并且向下弯曲然后在上述平面内向后弯曲到上述末端。在另一项改进中,所述细长件的远端部分是狭窄的并且向下弯曲然后在所述平面内向后弯曲到所述末端。在另一项改进中,轴上的导引装置接收细长件并具有靠近手柄的近端和远端开口,该远端开口露出金属丝的远端部分(金属丝的远端部分位于所述导引装置的远端开口前方),并从细长件的远端部分向后限制细长件至邻近手柄的位置。它可以进一步包括在细长件上的邻近手柄的操纵器,用以选择性地推进和缩回细长件的末端。
同时被描述的是一种用于将补片钉合至在腹股沟疝修补位置处的身体组织的器械,该器械包括:具有近端和远端的轴;在轴的远端处的钉合钉排出头;在头内的钉合钉,钉合钉具有大体U形的结构,具有在第一平面内的间隔尖头;在上述头上的排出端口,用于从所述头通过排出端口向外射出所述钉合钉;以及补片操纵器,连接至头并具有邻近端口的末端,操纵器的末端与所述第一平面以一小段距离相间隔,以避免当钉合钉从端口向外射进入补片时,上述末端与钉合钉接触。
同时被描述的还包括,在腹股沟疝修补中,一种将覆盖疝膜的补片连接至邻近疝气位置和疝气位置周边的身体组织的方法,该方法包括:将钉合器械的头插入以所述组织为边界的开口内,并朝向所述开口的邻近侧处的所述补片向下指引钉合钉排出端口,并在所述开口近侧的多处位置处,从所述端口穿过所述补片将钉合钉发射入邻近所述疝气的一些所述组织中;移动钉合器械的头进入以所述组织为边界的开口内,并朝向在所述开口远侧的所述补片向上指引钉合钉排出端口,并在所述开口远侧的多处位置处,从所述端口穿过所述补片将钉合钉发射入一些所述组织中。此方法可进一步包括将所述补片与探针端点接合,探针端点安装于所述头并位于所述端口与所述补片之间,以及利用所述探针移动所述补片以将所述补片定位在所述组织上的位置处(在该位置钉合钉被发射到所述补片和所述组织内)。此方法可进一步包括通过用所述探针端点推动所述补片和/或用所述探针端点拉动所述补片来移动所述补片。拉动补片可被用于抬起在所述远侧上的所述补片。补片可被刺穿以有助于所述补片的所述移动。
Claims (6)
1.一种外科手术钉合器,包括:
细长轴,其近端具有手柄,且远端具有向下设置的排出头,并且所述外科钉合器还包括安装在所述排出头和所述轴之间的有角度的钉合钉仓。
2.根据权利要求1所述的外科手术钉合器,其中,所述排出头经由纵向延伸穿过所述轴的致动组件被所述手柄中的触发器驱动。
3.根据权利要求2所述的外科手术钉合器,其中,所述致动组件包括在所述轴的直线部分中的刚性杆和跨越所述轴的弯曲部分的柔性件。
4.根据权利要求1-3中任一项所述的外科手术钉合器,进一步包括从所述排出头延伸的一个或多个补片操纵器。
5.根据权利要求4所述的外科手术钉合器,其中,所述一个或多个补片操纵器包括多个固定尖头。
6.根据权利要求4所述的外科手术钉合器,其中,所述一个或多个补片操纵器是可伸缩的。
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- 2009-03-13 KR KR1020107020175A patent/KR20100135740A/ko not_active Application Discontinuation
- 2009-03-13 JP JP2010550893A patent/JP5536679B2/ja active Active
- 2009-03-13 CA CA2716820A patent/CA2716820A1/en not_active Abandoned
- 2009-03-13 WO PCT/US2009/037119 patent/WO2009114779A2/en active Application Filing
- 2009-03-13 AU AU2009223238A patent/AU2009223238A1/en not_active Abandoned
- 2009-03-13 CN CN2009801086331A patent/CN101969862B/zh not_active Expired - Fee Related
- 2009-03-13 CN CN2012103585215A patent/CN103006283A/zh active Pending
- 2009-03-13 BR BRPI0906176A patent/BRPI0906176A2/pt not_active IP Right Cessation
-
2010
- 2010-08-29 IL IL207850A patent/IL207850A0/en unknown
- 2010-09-13 US US12/880,492 patent/US8827135B2/en active Active
Patent Citations (3)
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US4540110A (en) * | 1983-06-28 | 1985-09-10 | Minnesota Mining And Manufacturing Company | Bone stapler |
US5376097A (en) * | 1991-04-05 | 1994-12-27 | Phillips; Edward H. | Surgical fastener system |
US20020117534A1 (en) * | 1991-10-18 | 2002-08-29 | Green David T. | Apparatus and method for applying surgical staples to attach an object to body tissue |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN108472034A (zh) * | 2015-12-28 | 2018-08-31 | 伊西康公司 | 具有偏轴外科紧固件递送的施用器械 |
US11491000B2 (en) | 2015-12-28 | 2022-11-08 | Ethicon, Inc. | Applicator instruments having stacked surgical fasteners for off-axis surgical fastener delivery |
Also Published As
Publication number | Publication date |
---|---|
JP2011515125A (ja) | 2011-05-19 |
CN101969862A (zh) | 2011-02-09 |
WO2009114779A2 (en) | 2009-09-17 |
EP2257227A4 (en) | 2014-03-26 |
KR20100135740A (ko) | 2010-12-27 |
IL207850A0 (en) | 2010-12-30 |
WO2009114779A3 (en) | 2009-12-17 |
MX2010009586A (es) | 2011-02-22 |
US20100327042A1 (en) | 2010-12-30 |
BRPI0906176A2 (pt) | 2019-09-24 |
CA2716820A1 (en) | 2009-09-17 |
EP2257227A2 (en) | 2010-12-08 |
JP5536679B2 (ja) | 2014-07-02 |
US8827135B2 (en) | 2014-09-09 |
AU2009223238A1 (en) | 2009-09-17 |
CN101969862B (zh) | 2012-11-21 |
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