CN1292665A - 一种用于封闭血管中的开口的缝合装置 - Google Patents

一种用于封闭血管中的开口的缝合装置 Download PDF

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CN1292665A
CN1292665A CN998038695A CN99803869A CN1292665A CN 1292665 A CN1292665 A CN 1292665A CN 998038695 A CN998038695 A CN 998038695A CN 99803869 A CN99803869 A CN 99803869A CN 1292665 A CN1292665 A CN 1292665A
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安东尼·A·诺布尔斯
斯蒂文·E·德克尔
本杰明·G·布罗舍
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
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    • AHUMAN NECESSITIES
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    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0491Sewing machines for surgery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00637Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for sealing trocar wounds through abdominal wall
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00646Type of implements
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00672Locating means therefor, e.g. bleed back lumen
    • AHUMAN NECESSITIES
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    • A61B2017/00867Material properties shape memory effect
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0469Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
    • A61B2017/0472Multiple-needled, e.g. double-needled, instruments
    • AHUMAN NECESSITIES
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    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06004Means for attaching suture to needle
    • A61B2017/06042Means for attaching suture to needle located close to needle tip
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
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    • A61B2017/2911Handles rings

Abstract

一种允许医师远距离地缝合在血管(16)或其它生物组织内的切口(26)的缝合装置(520),该装置(520)包括:一个带有末端(515,522)的延伸管状体(514,515),该延伸体可用来经过切口(26)经皮插进血管(16)中。该末端(515,522)至少具有从延伸体(514,515)末端(515,522)伸出的第一和第二可伸缩性夹臂(524,525,525’,630,630’,660,662),该夹臂能够在血管(16)内可释放性地抓住缝线(40)。沿延伸体(514,515)邻近可伸缩性夹臂(524,525,525’,630,630’,660,662)的位置提供了第一和第二可伸缩性针(546,650),每根针被配置成可从相应夹臂(524,525,525’,630,630’,660,662)中抓住缝线(40)。医师可使用一个由装置(520)末端部分所提供的手柄(550,600,700)或其它的控制机械装置来远距离移动可伸缩性夹臂(524,525,525’,630,630’,660,662)和第一和第二可伸缩性针(546,650)。在操作过程中,夹臂(524,525,525’,630,630’,660,662)首先在血管(16)内展开以抓住在管状体之外的缝线(40)的一端。针(546,650)然后展开再缩进延伸体(514,515)内,同时,针(546,650)刺进切口(26)大体两侧的血管(16)壁(22),从可伸缩性夹臂(524,525,525’,630,630’,660,662)中释放缝线头,通过血管壁(22)拉回缝线(40)。该缝合装置对于在进行导管插入操作过程之后进行动脉内切口(22)的闭合十分有用。在一个实施例中,在缝合过程中,所使用的用于完成导管插入操作的导管鞘插入器(6)被留在适当的位置。

Description

一种用于封闭血管中的开口的缝合装置
本发明涉及一种医疗缝合装置。尤其涉及一种用于闭合动脉开口或医师难于直接接触的其它生物组织开口的缝合装置。
医师通常使用缝合技术来闭合人体的不同生物组织(如血管)中的切口、穿口或其它开口。
在一个动脉导管插入操作步骤中,需要在大腿或其它的动脉中做一个相对较小的经皮的切口。将一个导管通过切口插入并沿一动脉管道引向一目标区域(如心脏),以完成一项或更多的操作(如血管成形术)。这些操作过程是设计用来针对相对快速的“门诊病人”的步骤。
一旦完成导管插入步骤,医师通过对病人的大腿施加直接压力而使切口附近的血液凝结从而形成一个“血栓斑”。因为没必要通过施压而使大腿动脉完全阻塞(闭合),因此医师通常在该插入操作之后的第一个二十分钟期间用手施加直接压力。在此期间,医师可以感到脉冲以确定动脉未被闭合。此后,医师将该操作过程移交给助手,该助手则通过沙袋、夹具或其它的装置来施加直接压力。使用这种方法的一个显著的问题在于,通常需要施加更长时间的压力(如24小时或更长时间)。
使用血栓斑方法的另一问题在于,当对大腿施加直接压力或移去直接压力时,在动脉中的高血压可以引起血栓斑的破裂或爆裂。这就使得必需重复进行整个操作步骤。如果不修复血栓斑的破裂,将会导致病人出血死亡。由于血栓斑经常爆裂,所以病人必须经常彻夜呆在医院或导管插入实验室以作观察。这样,仅仅因为难以制造一个血栓斑,就使得这些“门诊病人”操作过程变成了“住院病人”操作过程。另外,住院也增加了病人的不便和住院费用。这也和所进行的实际医疗过程不相称。
而且,如果不能形成一个血栓斑,医师可能需要对病人进行麻醉,阻塞流向动脉的血液,在大腿上制造一个大的切口以允许使用传统方法来用针线进行缝合,再恢复流向动脉的血液,缝合大腿上的切口。这样会导致病人额外的不便并增加医疗费用。
如果在进行导管插入之后立即进行血管缝合步骤,也许可以避免上述问题,但是同时又引发另一个问题,即动脉的尺寸和位置使得缝合十分困难。特别是,大腿的开口太小太深而使得不能够为使用传统方法缝合动脉提供足够的工作空间。这样,为了用传统方法缝合动脉,将会显著扩宽在大腿中的开口,从而增加了病人额外的痛苦、也增加了形成瘢痕和影响健康的危险。
本发明通过提供一种用于缝合在生物组织壁(如器管或血管)中的开口的缝合装置及其缝合方法来提及上述问题的。该装置尤其适合于缝合在伴随有导管插入操作的动脉(如大腿动脉)中所作的开口。该装置无需对病人大腿施加延长周期的压力,也免除了制造血栓斑所带来的复杂性和费用的问题。
在一最佳实施例中,该装置包括一个细长的带有末端的管状体,该管状体可用来通过一个最初切口经皮被插入进血管中。该末端具有一对可伸缩自如的臂,该臂可在血管内从延伸体的末端延伸出去并可释放性地抓住缝线。该臂可从延伸体的相应两侧缩进和伸出。
沿延伸体邻近可伸缩臂提供了第一和第二可伸缩的针,每根针被设置成可从相应的可伸缩臂抓住缝线或缝线的环端。医师可使用手柄或其它的由该装置末端提供的控制机械装置对臂和针进行远距离移动。可通过针从延伸体远侧地朝外伸展(最好在使用过程中通过弯曲朝外)以抓住缝线。
在操作过程中,一个标准的导管鞘插入器(CSI)被用来将导管插入进血管中,紧随该导管插入操作之后,通过该CSI将延伸体的末端插入进血管中。在缝合过程中,最好将CSI大体留在所插入的位置中。在插入过程中,将可伸缩臂保留在其收缩位置。一旦进入血管,该臂在细长导管状体(延伸体)的边缘之外展开抓住缝线的一端。使用一个控制柄,可使针展开然后缩进延伸体内,在此期间,针刺穿切口的大体相对两侧边上的组织壁,通过可伸缩臂释放及抓紧缝线端,然后拉着缝线一端穿过组织壁。然后臂移至其收缩位置,将该装置从血管中及带有缝线头的病人体内收回。在切口位置作一个结或加一个缝合夹以闭合该切口。
根据本发明,由此提供了一种远距离封闭在血管或其它的生物组织内的切口的缝合装置。该缝合装置包括一个带有可通过切口插入到血管内的末端部分的延伸体,该末端部分具有一个带有由此而形成的第一和第二孔的外壁。延伸体进一步包括邻近末端的第一和第二针端口,以使得当末端部分位于血管之内时,该针端仍保留在血管外。该装置进一步包括可分别从第一和第二孔缩进和伸出的第一和第二臂,该臂可释放性地抓住缝线。双臂可远程移动到展开位置,在此位置双臂可从延伸体内伸出抓住离开延伸体的缝线。分别从第一和第二针端口伸出第一和第二针以抓住缝线。针可在收缩位置和伸展位置之间远程移动,在收缩位置时,针藏进延伸体内;在伸展位置时,针朝向延伸体外从针端口向远侧伸展。针从收缩位置向伸展位置移动,再回到收缩位置,同时,双臂在血管中展开并抓住缝线,使得针刺穿血管,双臂释放缝线,从血管中拉回一部分缝线。
延伸体的末端区(包括针和针端口)最好设置成可通过一个用于完成导管插入操作的标准CSI来经皮插入病人体内,以使得无需从病人体内移去CSI便可以使针伸展和收缩以抓住及拉回缝线。在延伸体的基部区的外表面最好包括一个标尺,以指示CSI可部分回拉以暴露针端口的纵向位置。
当在收缩位置时,针最好成一个较直的形状,而在伸展位置时,则最好呈从体内向外弯曲的形状。针端口最好包括一个针标,利用该针标可施加一个外加压力给针以向外弯曲。在一个实施例中,每根针包括一个可抓住缝线环的凹槽。在其它的实施例中,每根针包括一个环形刻槽,该刻槽是用来连接缝线环或者固定在缝线末端的。
第一和第二臂最好与一个可活动的弹性合页内部连接起来,当合页在松驰状态时处于部分张开位,此时可支撑双臂。活动合页最好和一对在延伸体体腔内伸展的传动杆相连,当给传动杆施加近端力时可使双臂从部分张开状态移至展开状态,而给传动杆施加末端力时可使双臂从部分张开状态移至收缩状态。当双臂收缩进延伸体内时,第一和第二臂的外表面最好与延伸体的外表面齐平,且双臂大体与延伸体平行。当双臂处于张开位置时,第一和第二臂最好与延伸体大体呈90°向外延伸。双臂最好在延伸体的末端尖处分隔开,以免在操作过程中双臂接触切口对面的血管壁。
延伸体的末端最好包括至少一个血液端口,通过该端口与延伸体内的腔液体联结。内腔延伸到延伸体的近端部分以允许医师来确定末端部分是否进入血管中。内腔还可以与一个压力传感器相连以便指示末端部分是否进入血管中。
图1A是根据本发明对在一个示范使用环境中的一个缝合装置末端部分的示意图,其中该缝合装置是以切断形式表示的。
图1B是图1A所示缝合装置的横截面示意图。
图2是根据本发明一个实施例中对于图1A所示缝合装置的结构横截面示意图,其中该装置的末端是插入到血管壁内。
图3是图2所示缝合装置的横截面示意图,其中,夹臂处于部分张开状态。
图4A是图2所示缝合装置的透视切断图,其中显示了一个缝合夹臂、一个传动器和一个空心延伸体。
图4B是图4A所示的缝合夹臂、枢轴和传动杆的暴露图。
图4C是根据本发明另一实施例中的两片缝合夹臂的透视图。
图4D是图4C中所示的两片缝合夹臂的截面示意图,以及一个在缝合插入器头部内的展开器。
图5是图2中所示的缝合插入器头部和夹臂构件的透视图。
图6是图2中所示的缝合装置的透视图,其中缝合夹臂部分张开并抓住一根缝线。
图7是图2中所示的缝合装置的透视切断图。
图8是图2中所示的缝合装置的横截面示意图,其中缝合夹臂完全张开并在血管内抓住一根缝线。
图9是图1A中所示的缝合装置的另一实施例的横截面示意图。
图10是根据本发明一个实施例中对图1A中所示的缝合装置的手柄的横截面示意图。
图11是图10所示手柄的透视图。
图12是根据本发明另一个实施例中的一个手柄的横截面示意图。
图13A是图1A中所示的缝合装置的另一实施例的透视图。
图13B是图13A所示装置的横截面示意图。
图14A-14B是图13A所示的缝合夹臂的两片配置的透视图。
图15是图13A所示装置的透视图,其中缝合夹臂部分张开。
图16是图13A所示装置的透视图,其中缝合夹臂完全张开。
图17是图13A所示装置的透视图,其中缝合夹臂完全张开,针与缝合夹臂啮合。
图18是对带有如图10所示手柄的图1A所示缝合装置的透视图。
图19-20是根据本发明另一个实施例中的四臂卡具装配的透视图。
图21是根据本发明另一个实施例中的手柄的暴露图。
图22是图21所示手柄的透视图。
本发明提供了一种用于缝合生物组织的缝合装置。该缝合装置的不同实验例描述如下。在所公开的实施例中,该缝合装置适合于封塞血管中的切口。熟悉本领域的技术人员将会明白,该缝合装置也可用于封塞其它类型的生物组织的切口,如明显的管状动脉、心脏缺陷、或者刺穿伤口。
图1A-1B图1A是根据本发明一个最佳实施例中对在一个示范使用环境中的一个缝合装置520的示意图。在图1A-1B中,缝合装置520是被用来在经皮导管插入操作过程之后进行缝合血管16的。在经皮导管插入操作过程中,医师对病人2的上部大腿12制作了一个初始切口20。然后医师将一根针(未显示)插入进切口20中。当从插入部位中渗出血液,医师即可得知针已通过血管切口26刺进大腿动脉16中。医师再通过针插入一只引导线(未显示)进入到动脉16中。一旦引导线就位,医师就拨出针并在导线上插入一支塑料针(未显示)。然后再取出引导线。
利用这支到位的针,医师可以插入一个导管鞘插入器(CSI)6,也可称之为插入器鞘。插入器鞘6一般是一个在其近端带有一个阀的单腔导管。阀是用来防止过多的血液回渗或者将药物引入病人体内。血管切口26提供了医疗装置和要插入到动脉管16内的探针的入口。缝合装置可通过一个插入器鞘6插进动脉16中以完成不同的医疗操作。例如,可通过一个插入器鞘6将导管插入并沿动脉管道指向目标区(如心脏)来完成一项或更多项的经皮方法操作(如血管成形术)。
在完成上述医疗操作之后,医师通过导管鞘插入器CSI6将缝合装置的末端部分520插进生物组织14中,如图1A-1B所示。缝合装置的末端部分520通过导管鞘插入器CSI6再进过血管切口26进入到大腿动脉16内。缝合装置520被用来将缝线经过血管16的壁22放在血管切口26的每一侧,以使得可有效可靠地地闭合切口26。
在下面将会详细叙述到,末端部分包括一对可在血管16内可释放性地抓住缝线的可伸缩臂524(见图1B)。一套具弹性的可伸缩的针546(见图2)被用来刺穿切口26相对两侧的血管16,从臂中抓住缝线头,从血管16中拉回缝线头。在以下实施例中将会叙述,医师可以通过使用一个操作杆来按需要远程展开和收缩臂和针。一旦抓住缝线头并从血管16中拉回,则可从CSI和病人大腿抽回带着缝线头的缝合装置520。
图2是图1A所示缝合装置的最佳实施例的横截面示意图,其中,该装置末端经过切口26插入血管壁22中。在图2中,缝合装置520包括一个缝合插入器头522,一个延伸体514,一个传动杆50,一个传动杆内腔530,一个缝合夹具500,一个轴针502,一对缝合夹孔508,一对可活动的针546,在每根针546上的一个缝合扣锁38,一对针端口或孔510,一对针插入导标512,一对容纳针的内腔516,一根缝线40,以及在缝合插入器头522末端的一个孔540。缝合夹具500包括一对缝线夹臂524,一对前突(缝线夹臂止动器)528,一对缝线夹臂524的合页部分542以及一对缝线夹544。图2所示装置是在插入血管16之后但未展开缝线夹臂524之前的示意图。如图1B和图2所示以及下述内容,在插入该缝合装置之后,CSI6从血管16中抽回将针端口510暴露出来,但仍保留在大腿内。如图9所示,装置520可调整其结构,将一个单独的缝合插入器头522替换成一个整体或壳515。
缝隙合装置的尺寸可根据缝合位置以及要缝合的生物组织而改变。在一种用来缝合大腿动脉16的配置中,缝合插入器头522的直径大约为0.105英寸,空的延伸体514的直径在约为0.098英寸。
如图3和图5-8所示,每个针的端口510对应于一个相应的缝线夹臂524。每根针端口510包括一个朝外弯曲的槽或沟的针导标部分512(“针标”),该部分是用来引导相应针546沿特定轨迹运行的。针标512可在缝合插入器头522内作为模的一部分而形成(如图2所示),或者是在制作过程中被插入到缝合插入器头522的分离片(未显示)。
如图8所示,针的末端展开到伸展位,针标使针546朝外弯曲以使其刺穿切口26两侧的血管,然后联接伸展开的缝线夹臂524以抓住相应的缝线40头上的环。此后,针546收缩并通过由针穿出的穿切口248将缝线40的一端拉回。
图7显示了一个带有五个内腔的中空延伸体514的较好配置。内腔516中的两个被用来装针546(图2),腔530被用来装传动杆50,腔532被用来控制缝线40的长度以免其缭绕在一起。缝线40可装进传动杆内腔或在一个钻进缝线夹臂500中的孔中。
第五个内腔534最好是用于“回渗”,以使医师可由此判断在部分移去CSI6后的缝合插入器头522的末端504是否仍在动脉16中。回渗是通过在缝合插入器头522的末端504上的孔540(图5)、缝线夹臂孔508、以及任何其它的在缝合插入器头522中的开口来完成的。图2和图9中示意出了回渗的血液流动方向。缝合插入器头522的末端504仍在动脉16中,由血液流入孔540中所测得的血压将高于末端504不在动脉16中所测得的血压。在一个实施例中,回渗腔534延伸到一个在该缝合装置近端部分的一个端口(未示),医师可以从该端口通过监测血流来观察经过回渗腔534的血压。例如,回渗腔534可连接到一个气球上,当缝合插入器头522的末端504在动脉16中时该气球就会膨胀。在另一实施例中,将一个压力传感器与回渗腔534相边以使医师可以进行定量观测。可以替换地,第五个内腔534也可用于注射药物或者用于诊断目的。
如图7所示,在延伸体514的外部刻有两条细斑纹带。斑纹条538可通过指示两根针538的圆周位置来指示缝合插入器头的旋转方向。斑纹条538沿病人肉体14之外的延伸体514的一部分伸展。斑纹条538可帮助医师将针546与血管16对齐,以使针的刺口248(图8)纵向排列。如图2所示,缝线40最好垂直于血液流动方向来闭合动脉血管开口26,因为这是最有效的闭合开口26的方向。针546的正常插入也减少了损坏血管壁22的危险。可选择地,在另一种配置中,仅有一个斑纹条提示两根针546中的一根针的圆周位置。由于另一根针与这一根针处于180°角度的位置,因此医师也可以判断另一根针的位置。
如图7所示,延伸体514的外表面包括一个标尺539,该标尺是用来指示在缝合装置520的末端部分插入血管16之后的CSI6应部分拉回以暴露针孔510的距离近端的位置。下面将会描述CSI6被部分拉回的过程。标尺539是以可视标记显示的,但是也可以是脊、槽、或是其它的能与CSI的相应构件相作用的物理构件,以使得医师可以通过感觉来定位CSI6。例如,当CSI6沿延伸体514到达正常位置时,CSI6和延伸体514可配置成可放开连接或内部连接。一种包括这种内部连接结构的特殊形式的CSI6均在本发明所述范围之内。可以沿延伸体514的方向提供一种或多种的纵向标记(未显示),以指示CSI6和延伸体514的其它相对位置,如在可伸缩臂524暴露在CSI6之外的位置。
如图2-4B所示,缝合装置520包括附在传动杆50之上的一个简单的有弹性的缝合夹具500。图中所示的是这种弹性缝合夹具500的整体构造。缝线夹臂500包括一个中心或合页部分542以及两个缝线夹臂524(一个用于每根针546)。每个缝线夹臂524的头部带有一个缝线夹544。
缝合夹具500的合页部分542是个“有生命的合页”,因为它带有记忆,当(通过杆50)释放压力时,它可以引起缝合夹具500返回到部分张开的未收缩位置的状态(如图2和3所示)。在图3中,缝合夹具500在动脉中在其预置的位置(松驰或自然地)展开。在图2中,当缝合夹具500的处于压缩(应力或张力)位置时即会缩进缝合插入器头522中。通过对传动杆50施加一末端压力,即可使臂524移到收缩位置,从而引起臂接触偏转面518(如图3所示)。
缝合夹具500最好由具弹性的形状记忆材料如NITENOL组成。缝合夹具500也可以由一些具有弹性的替代性材料组成,如塑料、弹性钢、不锈钢或其它的类似材料。进一步地,缝合夹具500也可以由双臂组成,该双臂以枢纽式连接在传动杆50上而不用弹性合页,如图4C和4D所示,下面也会详述。
活性合页的配置很易于修改成具有三个臂(间隔成120度角)或改成四个臂(间隔成90度角)。若是三个臂,则在延伸体514内最好有3个针546和6个腔。由此,其它的配置以臂数也可以包含进该缝合装置中以完成特定的工作需求。
针546是可弯曲的,最好是由形状记忆材料如SUPERFLEX NITENOL组成。可替代地,针546也可以由弹性钢、外科不锈钢或其它的类似材料组成。针546的直径最好是0.019英寸,但也可根据本发明使用另外的直径。
当针546以末端前进并与插入导标512接触时,插入导标512使针546径向朝外弯曲。当针546与缝线夹臂546的角面545相接触时,它们也最好可以进一步略微弯曲(径向朝外),如图8所示。当针546缩进针腔516中时,针546在弹性作用下恢复成直的形状。尽管在图2-9中使用了在展开过程中可弯曲的针,但是我们还可以使用不能弯曲的针(或直或弯)。
如图4A-4B所示的切断图,传动杆50通过一个轴钉502与弹性缝合夹具500相连。以这种配置的传动杆50最好包括一个简单的柄(如图所示),但是在其它的配置中也可以包括多个柄。
图4C是非活性合页或一个双片缝合夹具501的透视图。图4D是双片缝合夹具501和在缝合插入器头522内的一个滑道或展开器523的横截面图。可替代地,在其它的配置中,缝合夹具501的合页部分类似于图14中所示的合页部分(将在下面叙述)。展开器523可以是一个附着在缝合插入器头522内的单独的片。可替代地,展开器和缝合器插入器头522也可以包括一个单独的模片。
缝线夹臂525的长度最好是0.174英寸左右,两个缝线夹臂525及525′在其完全伸展位置(两臂展开互相平行)时的长度约为0.288英寸。在其它的缝线夹臂525及525′的配置中,其尺寸也可以变化。
在图40中,当传动杆50以近端拉双片缝合夹具501(当双片缝合夹具501处于收缩位时)时,展开器523的末端与缝线夹臂525及525′的顶部相接触。展开器523引起两个缝线夹臂525及525′相对于传动杆50径向向外张开。在一种较好的操作方法中,传动杆50继续以近端拉双片缝合夹具501直到双片缝合夹具501的中心与展开器523的中心相啮合。为了将缝线夹臂525及525′缩进到缝合夹具有收缩位,传动杆50以末端式前进,插入器头522的内部边缘518与缝线夹臂525及525′相接触。插入器头522的内部边缘518引起两个缝线夹臂525及525′相对于传动杆50径向向内缩进。如下所述,对双片缝合夹具501的一般操作和使用与图4A中所示的单片缝合夹具的操作相类似。
缝合装置520的近端部分最好包括一个可使医师从外部操作在血管16中的缝线夹臂524和针546的手柄。该手柄有三个作用:第一个作用是使传动杆50对合页部分542施加一个近端的压力以展开并保持臂524在一完全朝外的位置(图8);第二个作用是使针546末端式前进(图8)并用一个或更多的弹簧近端式拉回针546;第三个作用是传动杆50施加一个末端力给合页部分542以收缩臂524(图2,4D或9)。
可替换地,手柄可以具有两个功能,其中一个功能是将上述三功能式手柄中的两个功能接合起来。例如,在第一个功能中,使传动杆50对合页部分542施加一个近端的压力以展开并保持臂524在一完全伸展的位置(图8)。当臂524处于完全伸展的位置时,针546自动末端式前进(图8)并近端式收缩以抓住缝线40的环端。这种双功能的第二个作用是使传动杆50施加一个末端力给合页部分542以收缩缝线夹臂524(图2,4D或9)。这种双功能形式的手柄适合于在操作这种缝合装置524有更多操作经验的医师。对于这项技术中的一般技巧之一,很明显地,可以使用一功能或四功能式的手柄(插入和拉回针546是作为两个单独的功能),或者也可以使用分离的或触发手柄以用于不同的功能。下面将会叙述不同的手柄设计。
图10是根据本发明一个实施例的一个手柄550的横截面示意图。该手柄被可操作性地连接在中空延伸体(虚线显示)的近端,这种手柄可在本发明所公开的任一实施例中使用。图11是图10中所示手柄550的横截面切断透视图。图18是整个缝合装置520的透视图,其中包括图10中所示的手柄550。
手柄550包括一个传动杆孔551,一个主外壳552,一对合页柄554,一个带有锁定槽576的缝线夹臂阀556,一个至少带有一个上升主端562的针阀560,一个带有锁定止动器572的释放器568,一个轴钉570,一个释放器撑杆574,一个压缩弹簧(未附)被可活动性地置于在缝线夹臂阀556和针阀560之间的弹簧凹座578,带有至少一个刻槽凹处564和针夹584的针阀支撑筒580。
在一种配置中,外壳552被附着在图2中的中空延伸体514或图9中的简单缝合插入及收缩室或图13A的缝合装置之上或作为它们的一个延续。在另外的配置中,外壳552与图2中的中空延伸体514或图9中的简单缝合插入及收缩室或图13A的缝合装置相分离的。在这种配置中,传动杆50将外壳552与图2中的中空延伸体514或图9中的简单缝合插入及收缩室或图13A的缝合装置相连接。
如图2,4D或9所示的传动杆50的近端部分通过传动杆孔551滑到外壳552的末端部分。传动杆50的近端附着在缝线夹臂阀556的末端558上,使后者可以滑动性收缩进主外壳552中。一个压缩弹簧(未附)置于缝线夹臂阀556和针阀560之间的外壳552的弹簧凹座578并同时施加两个压力:一个是对缝线夹臂阀556的末端力,一个是对针阀560的近端力。
针阀560的针夹584抓住针546的近端。针阀560在腔室553的末端部分内被滑动地接收。针阀支撑筒580被附着在外壳552上并最好与外壳552不产生相对移动。
释放器568以枢纽为支点绕轴钉570径向向内或向外移动。释放器支撑杆574对释放器568施加一个径向向外的力。当锁定槽576被安置到正确位置以接收锁定止动器572时,该力可引起释放器568绕轴转动并锁定止动器572使之落进缝线夹臂阀556的锁定槽576中。释放器支撑杆574最好由一种弹性形状记忆材料如NITENOL组成。释放器支撑杆574也可以由其它的具有类似弹性的材料组成,如塑料、弹性钢、不锈钢或其它的类似材料。下面将参照图12,21和22对手柄的另外实施例进行描述。
下面参照图1A-11进一步详细描述缝合装置520和手柄550的使用和操作。在操作过程中,利用伸进病人动脉16(未显示)内的CSI6,医师缝合装置的末端通过CSI6插入进动脉16中(图1A-1B),使得针端口保持在动脉510之外。然后沿缝合装置520的延伸体514近端式部分拉回CSI6并从动脉16中移去CSI6以暴露针孔510,如图2所示。CSI6的部分移开的距离(大致相对于延伸体514)大体小于在肉体14内的延伸体514的长度。在延伸体514的外表面有一个或更多个标记539(图7)是用来指示医师应该拉回CSI6以暴露针孔510的距离。通过CSI6插入和拉回缝合装置520的能力具有一个重要的优势:即可以减少干扰和损害病人大腿12和血管切口26的周围肉体14。
插入器头522的末端504具有一个光滑浑圆的表面以防止在插入插入器头522时伤害到对面的血管壁506。另外,由于插入器头522并未闭塞动脉16,因此在动脉16中的血液流动不受干扰。医师可以使用位于插入器头522的末端上的孔540和回渗腔534来确定何时插入器头522的末端504已在动脉16中。
如图2所示,当插入器头522已插入动脉16中时,传动杆50使弹性缝合夹具500在插入器头522内保持压缩位置。当插入器头522的内缘518对两个缝线夹臂524施加一个向内的力时,传动杆50则施加一个向下的力。两股力接合起来引起位于两个夹臂524之间的缝合夹具500的合页部分542塑性变形或压缩。如图2和图4A所示,缝线夹544抓住在缝线夹544的斜槽中的缝线40的环端。缝线40的环端被缝线夹544牢牢抓住,但又置于一个易于被针546的缝线抓38移去的位置。
当缝合装置520被置于血管16中的适当位置时(图2或9),医师可以通过向相对外壳552的方向(图11)拉指柄554来展开缝线夹臂524(图3)。医师可以通过将其食指和中指放在指柄554上并推外壳552的近端582来拉缝线夹臂阀556。其作用类似于操作一个标准的注射器。这种移动沿近端方向压缩了处于手柄550的弹簧凹座578内的弹簧(不显示)。当缝线夹臂阀556近端移动时,传动杆50沿近端方向相对于延伸体514或外壳515移动(如图3中箭头所示方向)。这一移动使得缝合夹具500展开或打开至其预置的或自然的位置(如图3所示)。缝合夹具500从插入器头522展开通过两个缝线夹臂孔508(图3)进入血管16,两个夹具分别位于插入器头522的两侧。
当医师将缝线夹臂阀556拉至一定的近端距离(相对于外壳522)时,位于释放器568末端的锁定止动器572径向向内移动并落进阀556的锁定槽576中。锁定止动器572与锁定槽576相联合阻止缝线夹臂阀556末端式前进。在凹座578内的弹簧的力阻止缝线夹臂阀556近端式前进。在针546末端式前进之前,缝线夹臂阀556的锁定使缝线夹臂524稳定在被锁定的位置。
在被锁定位置上,缝线夹臂524最好能够到达其完全伸展状态(如图8所示)。在这种完全伸展状态,传动杆50(附着在缝线夹臂阀556之上)已将弹性缝合夹具500拉起,孔508的近端内缘536已与缝合夹具500的臂524相接触(图8所示)。传动杆50的拉和孔508的固定内缘536可使得臂524向回弯曲直到臂524互相纵向排列(如图8所示)。这样,弹性缝合夹具500从其自然状态再次变形,但这次不是处于压缩位置而是处于伸展位置。在这种伸展位置下,当针546末端式前进并从缝线夹544抓住缝线40的头部时,医师可以近端式移动缝合装置520以使夹臂524接触到血管壁22的内部。
下一步,医师顺时针或反时针拧动针阀560直到针阀560升起的主体部分562与针阀支撑筒580的刻槽凹处564相配合。针阀支撑筒580的刻槽凹处564允许针阀560升起的主体部分562末端式前进。否则,如果升起的主体部分562与刻槽凹处564不相配合,针阀560则不能末端式前进。针阀支撑筒580和针阀560升起的主体部分562可防止针546过早或非正常地末端式前进。针过早或非正常地末端式前进可能会损害病人周围组织14(图1B)或血管16。
针阀560升起的主体部分562与针阀支撑筒580的刻槽凹处564相配合时,医师可以以相对于外壳552的近端582的末端方向使针阀560的近端前进(使用大姆指或手掌)。这种移动以末端方向压缩位于弹簧凹座578内的弹簧。当针阀560末端式前进时,针546和在针上的缝线夹38(图8)也末端式前进。
图8示意出了针546的路径。针546沿针腔516滑动并通过针孔510从缝合装置520出来。当针546与针插入导标512相接触时,针546开始径向朝外弯曲。当针546退出时,被针插入导标512径向向外与传动杆50呈锐角进行引导。针的偏转角度最好是13.2度。偏转角度也可考虑在10-15度和5-20度的范围。
然后针546以一定角度刺穿血管壁22并在主血管切口26的两侧创造切口248。由于与缝线夹臂的角面(图8)相接触,针546与缝线夹臂546相接触时,也最好略微弯曲(径向朝外)。针546上的缝线夹544和缝线抓38联合起来,可在缝线40的环端端制造一个扣,以使当针546与缝线夹臂500相接时而不使缝线头离开。
医师使针阀560呈末端式前进,直到压缩弹簧的阻力阻止了针阀560进一步地前进。在此位置,针546已充分进入到血管16中,此时当针546近端式拉回时,针546上的缝线抓38将会从缝线夹544中抓住缝线40的环端。如8图所示,夹臂524抓住远离缝合插入器头522的缝线环,使得针546刺入血管22中并抓住在缝合插入器头522圆周之外的缝线环。
当医师推进针阀560至其最远的末端位置时,释放针阀560。压缩的弹簧引起针阀560立即近端回弹。这一移动引起针546的末端部分立即近端回弹进行针腔516,同时也将附着在缝线抓38之上的缝线40的环端带入。
当针546近端回缩时,在针546之上的缝线抓38抓住夹在缝线夹544中的缝线环并通过针孔248将缝线40的末端拉起。当针546缩进针腔516中时,即恢复成直的形状。当针546回缩时,缝线40的长度被放开(由于收缩针546所引起的张力所造成的),从留在缝线腔532内的位置,通过缝合插入器头522的末端504上的孔540再进入到动脉16中。
要缩回缝线夹臂524(图2,4D或9),医师可沿径向向内压释放器568的近端部分。这一动作可以引起释放器568以枢纽式活动。锁定止动器572径向向外移动并释放锁定槽576。压缩弹簧的力引起缝线夹臂阀556和传动杆50以末端前进。结合插入器头522的近端内缘518,传动杆50向下的力可引起弹性缝线夹具500缩回至其压缩位置。如图5和图6中所示,缝线夹臂524缩进插入器头522的外表面上的相应的孔或槽508中。在这种缩回状态,夹臂524大体与延伸体514平行。如图5所示,夹臂524的外表面与插入器头522的外表面对齐。这样就减少了在拉回过程中夹臂524抓住血管壁22、肉体14或CSI6的可能性。现在就可以准备将缝合装置520从血管16中移去。
医师通过CSI6从血管16和病人大腿12的肉体14中拉回缝合装置520。当拉回缝合装置520后(CSI6仍在体14内),医师拉回缝线40头并关闭主血管切口26。医师然后用缝线40头系成一个结并经过CSI6滑下或拉下至切口26处。可替换地,医师也可以给缝线40头上拴一个小的环形的不锈钢夹(未显示)并通过CSI6将夹滑下到血管开口26处以闭合开口26。然后切断并移去不用的缝线40头(过长部分)。最后从病人体内将CSI6移去。
缝线夹臂524从缝合装置体的两侧径向展开(图2-3,8),而不超出装置520的末端504,这样就减少了缝线夹臂524接触和损害切口26对面的血管内壁506的可能性。
当针546与缝线夹臂524接触并抓住缝线40时,缝线夹臂524的锁定位置(参照图8所述)为抓住缝线40的环端提供了一个稳定的基座。缝线夹臂524最好通过施加在传动杆50、孔508的固定内缘和位于每根臂524的“眉”端的突出528上的近端力而在锁定位置被锁定。特别地,当缝线夹臂524大体互相平行时(即每个臂524与传动杆大致成90度),位于每根臂524的“眉”端的突出528则互相接触从而阻止缝线夹臂524过度弯曲超过图8中所示的情形。当针546以末端式插入并与缝线夹臂524相接触时,突出528最好能够阻止缝线夹具500无意识地移动或弯曲(张开过大)。这样就避免了在针546与缝线夹544相联时缝线40环端意外地从缝线夹544上移位。由此,由传动杆50、孔508的固定内缘、两个突起供同施加的力的组合能够使缝线夹臂524保持在一个严格的锁定位置以便于将缝线环端从缝线夹544中正常移去。
图2-9中的缝线夹544的倾斜槽的形状和位置提供了另外的优势。图2-9中的缝线夹544的槽以近端径向向内倾斜。因此,缝线40的环端面面向近端径向向内的方向。这种配置可以避免缝线40的环端不正常或过早地从缝线夹544中脱落。当针546与缝线夹臂524相合时,最好缝线40的环端的移动只有一个方向,即近端径向向内的方向,这是与插入的针546相对的方向。当针546近端式收缩(如图8所示)时,缝线40的环端可安全地落进针546的缝线夹38中。在图2-9中的实施例中的针546的近端式移动可引起针546的缝线夹38夹住缝线40的环端。
在参照图1A-9所述的不同实施例中,可伸缩的缝线夹臂被用来抓住超出管状腔外缘(由此也超出切口26的边界)的缝线40,而具弹性的针546则用来抓住在外缘之外的缝线40。在另外的执行过程中(未显示),缝线夹装配可以是以一种固定(不活动)组件的方式在腔室周围之内或附近抓住缝线40。在这种操作中,可以使用弯曲的针来刺入腔室周围之外的血管壁,然后“内曲”以抓住缝线。弯曲的针可以拉回从血管壁22出来的缝线头。
图12是柄600的另一实施例的横截面图,该手柄可用来替代图10中的手柄。图12中的手柄包括一个带有弹簧凹座622的外壳602、一对外部指柄604(图12中未显示)、一个带有锁定槽608的缝线臂阀606,一个带有锁定头610和针阀止动器618的释放器612、一个轴钉614、一个带有针夹616的和一个弹簧624的针阀620。
手柄600也包括一个第二弹簧(未显示),它可以使释放器612向一个位置倾斜,该位置是锁定头610与槽608相啮合的位置。与图10和11中所示的手柄550相类似,指柄604伸出外壳602之外以允许医师相对于外壳602移动阀606。图12中的针546的近端被附着在针夹616之上,二者均附着在针阀620之上。传动杆50(图2)被附着在缝线夹臂阀606之上(图12)。
图12所示的手柄600的一般操作与图10-11所示的手柄550的操作类似。在图12中,针阀止动器618防止针阀620过早或非正常地末端式前进。这一功能和图10-11中所示的上升主端562和手柄550的的刻槽凹处564的作用相似。在图12中,医师近端式推进缝线臂阀606同时对抗弹簧614的编斜力(通过近端式拉指柄604)以展开缝线夹臂524(图3)直至释放器612的锁定头610径向向内移动并落进锁定槽608中。在此位置,缝线夹臂524处于如图8所示的完全展开或张开的位置。这一移动引起了释放器612的近端部分径向向外前进直到针阀止动器618不再闭合针阀620。在此,医师可以末端式推进针阀620进入凹座622以引起针546末端式前进并抓住缝线40。当医师释放针阀620时,弹簧614近端式移动针阀至朝外的位置,引起针546带着缝线40缩回。最后,医师压下释放器612的外部杠杆部分以释放缝线夹臂阀606;这就引起了缝线夹臂524返回到收缩位置,由此可从动脉16中拉回缝合装置520。
在这种工艺中的一般技术将会期望有对这种附着在缝合装置520近端上的手柄有更多种可能的配置。在一种配置中(未显示),至少有两根弹簧或两套弹簧(未显示)来代替由图10-11中的手柄550和图12中的手柄600使用的单个压缩弹簧。在这个双弹簧的实施例中,第一个弹簧对针546施加一个近端力,同时第二个弹簧对手柄内的传动杆50施加一个末端力。在另外一种配置中,代替第二套弹簧或一个触发器,医师可以手动以近端式将针546收回进针腔516中。
图13A-17显示了根据本发明另一实施例的图1A的缝合装置。在此实施例中,为缝线40的末端提供了一个特殊的环或小配件41以啮合针650(图16)。如图14A所示,第一缝线夹臂630包括一个带有一个用于轴钉502的孔642的合页部分636(图4C)。第一缝线夹臂630进一步包括一个用于传动杆50的末端(图4B)的弯曲部分638和一个第二缝线夹臂630′的合页部分(图14B)。第一缝线夹臂630进一步包括一个用于抓住缝线环端41的角状凹座632、一个用于缝线40长度的狭缝640、以及一个倾斜端634。图14B显示了第二缝线夹臂630′与第一缝线夹臂630相类似,区别在于第二缝线夹臂630′没有一个用于传动杆50的末端的弯曲部分638(图4B)。
第一缝线夹臂630的长度最好是0.174英寸左右,两个缝线夹臂630及630′在其完全伸展位置(两臂展开互相平行)时的长度约为0.288英寸。在其它的缝线夹臂630及630′的配置中,其尺寸也可以变化。
如图16-17所示,每个可弯曲的针650包括一个展开的柄、一个刺入末端针尖654、以及在末端附近的一个刻槽652。针槽652是作为一个棘爪或缝线抓。在好的配置中,针槽652围绕针650的整个圆周伸展。在另外的配置中,针槽652沿针650的径向边缘呈部分圆周。环41的直径一般与等于针650的槽652的直径,但是在响应对针650的向下的力时必须具有足够的弹性来扩展直径。
缝线40的环端41可以这样形成:加热缝线的一端直到该端变成一个球形,然后将球形端压缩成一个盘形,在盘形端的中心作一个孔从而形成一个环。在一种配置中,缝线40包括一根单纤维或塑性缝线材料。在形成环端一种方法中,代替加热缝线段的一端,缝线端只被简单压缩并形成一个孔。线端进一步被切或印成一个圆环形。
在其它的配置中,代替在缝线端预形成孔,可利用针650的传动(参照图7如下所述)来形成孔并将缝线端系在针650上。在另外的配置中,一个单独形成的环可被成模插入、粘接、压制、或用类似的方法将其附着在缝线段的端头。
每个环41可以具有如图13A所示的环形形状,或者可以具有其它的恰当的形状如椭圆形、三角形、长方形、六边形或八边形。
图13A-17中所示的缝合装置的一般使用及操作大体与参照图2-9所述的相同。特别地,缝线40的环端41被置于缝线夹臂630,630′的角状凹座632内(图13A,15)。缝线插入器头522被插入到生物组织14(与图1A-2类似)中,缝线夹臂630,630′被近端径向向外展开(图16)。刺入的可弯曲针650经过生物组织至被缝线夹臂630,630′相啮合(图17)。
当针尖654经过缝线40的环端41,环端41立即径向向外弯曲。当针650继续末端式前进时,环端41与槽652相接触。由于环端材料具有弹性,环端径向向内收缩并系住针槽652,使得近端式拉针以引起缝线端41跟随针650的近端移动。由此,针槽652与上述参照图2-3和8所述的缝线夹(图2)的作用相同。
图19-20是一个四臂缝线夹装配的透视图。它可被用于与图1A-2所示的缝合装置520相类似的装置上。这种缝线夹装配包括四个缝线夹臂662-668。每个夹臂对应于该缝合装置的相应的针(未显示)和针端口(未显示)。四个缝线夹臂662-668中的每支臂均包括一个用于缝线段的角状凹座和槽。在一个实施例中,如图19-20中所示的装置使用了两根缝线,每根缝线均被一对缝线夹臂662-668抓紧。每根缝线的两端均有一个环,该环被置于缝线夹臂662-668的一个角状凹座中。也可以为缝线夹臂662-668提供上述公开的其它类型的缝线夹结构。
图21和22显示了根据本发明另一实施例的一个手柄700。手柄700包括一个姆指环702、一个活塞704、一个活塞末端706、一个主腔壳710、一个近端孔708、一个食指环712、一个倾斜的浮钉槽714、一个浮夹槽715、一个末端孔716、一个浮子720、一根钉718、一个浮夹锁722、一个浮夹724、一根驱动线(传动杆50)夹726、一个卡针具后座728、一个针卡具730、一个浮夹钉732、一个浮夹孔734、一根弹簧736、一根活塞钉738、一具L形锁定凹座740、以及一个推出(中空的延伸体514)夹742。
弹簧736、浮子720、浮夹锁722、浮夹724、驱动线夹726、卡针具后座728、针卡具730、浮夹钉732被可操作地收在主腔壳710之内。活塞704的柄通过浮子720、浮夹锁722、浮夹724被滑动性收入主腔内。
活塞704的方形或矩形柄配合在浮子720的方形或矩形轴向凹座之内,使得顺时针旋转活塞702就可以引起浮子720的顺时针旋转。活塞末端706被挤进(或类似的自附着于)卡针具后座728内。活塞钉738沿形成于主腔壳710内部的L形锁定凹座740被滑动性地接收。
在一个最佳配置中,L形锁定凹座740、浮钉槽714和浮夹槽715都是铸模成型、雕刻或类似方法形成形成于主腔壳710内。弹簧736也为浮子720提供了一个末端的倾斜力。
浮钉718沿倾斜的浮钉槽714被滑动性地接收。浮子720的末端挤入并锁进浮夹锁722的近端部分。浮夹锁722被胶合、连接或以类似的方法联连在浮夹724上。驱动线夹726装配在浮夹724的浮夹孔734之内。驱动线夹726被胶合、连接或以类似的方法联连在一根驱动线或传动杆50(图13B)上(或图2或图9)。
推出(中空的延伸体514)夹742被胶合、连接或以类似的方法联连在图13A所示的中空的延伸体514的近端部分。针卡具730最好被胶合、连接或以类似的方法联连在卡针具后座728上。图2中的针546或图16中的针650的近端部分最好被胶合、连接、成模或以类似的方法联连在针卡具730上。
现在参照图21来描述对手柄700的使用和操作。当手柄700处于其初始状态并送给最终用户时,在L形锁定凹座740内的活塞钉738阻止活塞704相对于主腔壳710近端式移动。当医师用姆指环702顺时针旋转活塞704时,活塞钉738沿L形锁定凹座圆周移动直至活塞钉738被置于末端式滑下到L形锁定凹座740的纵向部分内。
当医师旋转活塞704时,浮子720也随之顺时针旋转。钉718在倾斜的浮钉槽714内移动引起浮子720近端式移动。由于驱动线夹726被连接在驱动线或传动杆50(图13A)上,浮子720的近端式移动会引起浮夹锁722、浮夹724、驱动线夹726和传动杆50的近端式移动,使得缝线夹臂630及630′径向朝外展开(图13A-13B)。
一旦活塞702被完全旋转,同时活塞钉738被置于末端式滑下到L形锁定凹座740的纵向部分内时,医师就可以末端式推进活塞702。活塞702的末端式推进会引起针546(图8)或针650(图16)以末端式推进,进一步刺穿生物组织,与缝线夹臂524,630及630′相啮合(图8及16)。
以上显示和描述了本发明的实施例和应用,熟悉本领域的技术人员将会明白,对此所做的任何变动均在本发明的保护范围之内。因此,在下面的权利要求项中将会进一步对本发明的保护范围加以说明。

Claims (19)

1.一种用于远距离地缝合在血管壁或其它生物组织内的切口的缝合装置,该装置包括:
一个带有末端的延伸体,该延伸体可用来经过切口插入进血管中。该末端具有一个带有由此形成的第一和第二孔的外壁,该延伸体进一步包括位于临近末端的第一和第二针端口,以使得当末端部分插入血管中时针端口仍保留在血管外;
可分别从第一和第二针孔缩进和伸出的第一和第二夹臂,该臂可以可释放性抓住缝线,并可远程移至其展开位置,在此位置时,双臂从延伸体内向外展开抓住远离延伸体的缝线;以及
分别从第一和第二针孔伸出的用以抓住缝线的第一和第二针,该针可在收缩位置(针装在延伸体内)和展开位置(针从延伸体向外从针端口末端式向外展开的位置)之间远程地移动;
其中针从收缩位置向展开位置移动,再返回至收缩位置,同时,夹臂在血管内展开并抓住缝线,导致针刺进血管,从夹臂上释放缝线,从血管中拉回缝线的一部分。
2.根据权利要求1所述的缝合装置,其特征在于:
其中的延伸体的末端部分(包括针和针端口)被配置成使用一个标准的鞘插入器(CSI)经皮插入病人体内来完成一个导管插入过程,使得可以伸展和收缩针以抓住和拉回缝线而无需从病人体内移去CSI。
3.根据权利要求2所述的缝合装置,其特征在于:
延伸体的近端部分进一步包括一个在外表面的标尺,利用它可以用于指示部分拉回CSI以暴露针端的纵向位置。
4.根据权利要求1所述的缝合装置,其特征在于:
其中的针在收缩位置时大体保持直的形状,当在展开位置时,从延伸体向外弯曲。
5.根据权利要求4所述的缝合装置,其特征在于:
其中的针端口包括针标,该针标对针施加一个向外的力从而引起针的弯曲。
6.根据权利要求1所述的缝合装置,其特征在于:
该装置进一步包括一个联接在延伸体近端部分的手柄,该手柄包括用于远程移动针和夹臂的控制部分。
7.根据权利要求1所述的缝合装置,其特征在于:
其中的第一和第二臂与一个可活动的有弹性的合页内部分相连,当该合页处于松驰状态时,合页以部分张开的位置抓紧夹臂。
8.根据权利要求7所述的缝合装置,其特征在于:
其中的可活动性合页与一个在延伸体内伸展的传动杆相连接,对传动杆施加一个近端力会引起夹臂从部分张开位置移向展开位置,并且对传动杆施加一个远端力引起臂从部分张开位置移向收缩位置。
9.根据权利要求1所述的缝合装置,其特征在于:
当臂在延伸体内收缩时,其中的第一和第二臂的外表面与延伸体的外表面对齐。
10.根据权利要求1所述的缝合装置,其特征在于:
当缩进孔内时,其中的第一和第二臂大体平行于延伸体。
11.根据权利要求10所述的缝合装置,其特征在于:
当处于展开位置时,其中的第一和第二臂从延伸体以90度角径向朝外延伸
12.根据权利要求1所述的缝合装置,其特征在于:
其中的末端部分至少包括一个血液端口,该端口与延伸体的内腔可进行流体式相连,延伸到延伸体的近端部分的内腔可允许医师判断末端部分是否已在血管中。
13.根据权利要求12所述的缝合装置,其特征在于:
内腔与一个压力传感器相连,该传感器可为医师提供判断末端部分是否已在血管中的可视性指示。
14.根据权利要求1所述的缝合装置,其特征在于:
其中的双臂从延伸体的末端尖被近端式隔离开,使得在双臂的展开过程中,可防止双臂与切口对面的血管壁相接触。
15.根据权利要求1所述的缝合装置,其特征在于:
每根针都包括一个圆周式形成的槽,槽被配置成可与缝线环端相啮合。
16.根据权利要求1所述的缝合装置,其特征在于:
该装置进一步包括第三个和第四个夹臂,这些臂可从末端部分的第三和第四个孔缩进和伸出,并可释放性地抓住一个第二根缝线。
17.根据权利要求1所述的缝合装置,其特征在于:
该装置进一步包括至少一个标尺,以可视性地指示末端部分的旋转方向。
18.一种在导管插入操作之后闭合病人血管开口的方法,在此,导管鞘插入器(CSI)被用来将导管插入进血管中,它包括:
利用插入病人的皮肤再进入血管中的CSI,通过CSI插入缝合装置的延伸体的末端部分并进入到血管中,同时末端部分可释放性地抓住一根缝线;
利用在血管中的末端部分,沿延伸体近端式移动CSI而不从病人体内移出CSI,以沿延伸体暴露出针端口,针端口与末端邻近以使得针端口保持在血管外;以及
利用延伸经过CSI的延伸体,推动缝合装置的缝线夹具以引起该装置的可收缩针从针端口内伸出刺入进血管中并从末端部分释放缝线,然后缩进针端口内以从血管中拉回缝线部分;以及
经过CSI从病人体内拉回延伸体的末端。
19.根据权利要求18所述的缝合装置,其特征在于:
其中的延伸体包括一个标尺,以及近端式移动CSI的步骤包括使用该标尺以正常确定CSI相对于延伸体的位置。
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US8709020B2 (en) 2014-04-29
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