CN1513422A - 具有紧固件的射出机构的外科器械 - Google Patents

具有紧固件的射出机构的外科器械 Download PDF

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CN1513422A
CN1513422A CNA02154283XA CN02154283A CN1513422A CN 1513422 A CN1513422 A CN 1513422A CN A02154283X A CNA02154283X A CN A02154283XA CN 02154283 A CN02154283 A CN 02154283A CN 1513422 A CN1513422 A CN 1513422A
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J·J·库恩斯
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R·L·科克
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B·汤普森
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D·K·诺尔维勒
R·P·福克斯
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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
    • A61B17/064Surgical staples, i.e. penetrating the tissue
    • 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
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/10Surgical instruments, devices or methods, e.g. tourniquets for applying or removing wound clamps, e.g. containing only one clamp or staple; Wound clamp magazines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • 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
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0409Instruments for applying suture anchors
    • 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
    • A61B2017/0647Surgical staples, i.e. penetrating the tissue having one single leg, e.g. tacks
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/0063Implantable repair or support meshes, e.g. hernia meshes

Abstract

一种用于射出多个独立的外科紧固件的射出装置。所述射出装置包括:一个具有远端和近端的驱动机构。驱动机构具有一个运动部件和一个固定的相对部件,其中,运动部件可相对于射出装置向近端和远端运动。运动部件具有一个用于刺穿组织的锋利末端。所述射出装置包括至少一个设置在第一和所述第二部件之间的外科紧固件。至少一个外科紧固件中的每一紧固件均具有一个近端和一个远端。所述装置还具有一个带有至少两个顺序位置的促动器。第一位置用于使运动部件向远端运动并刺穿组织,而第二位置用于使运动部件向近端运动,从而调度紧固件的远端。

Description

具有紧固件的射出机构的外科器械
本部分继续申请涉及以下同时待审专利申请:系列号为No.09/692,633的申请[Attorney Docket No.END-668];系列号为No.09/692,627的申请[Attorney DocketNo.END-671];系列号为No.09/692,636的申请[Attorney Docket No.END-672],这些文献可在本申请中参考使用。
发明领域
本发明通常涉及一种外科器械,更特别涉及一种具有一个输送机构的外科器械,该机构用于从外科器械输送至少一个外科紧固件,以在对组织中的缺陷(如腹股沟疝)进行修复中固定一个假体。
本发明的背景
腹股沟疝为这样一种情况,即,一小圈内脏或肠经患者下腹部肌肉壁或腹股沟内的虚弱位置或损伤处伸出。这种情况通常在人体,特别是男性内产生。这种疝可以是患者一出生便具有的先天性缺陷,或可能由全力搬运或提升重物产生。已知重物提升可以在下腹部壁上产生大量应力并且可能在下腹部肌肉的虚弱点处产生破裂或撕裂以致产生损伤或孔洞。总之,可能导致患者遗留下肠组织经损伤伸出造成的难看凸起,痛苦,减小的提升能力,并且在某些情况下,会碰撞内脏,或如果切断流向凸起组织的血流,则可能产生其它并发症。
这种问题的通常解决方法可采用外科手术。在外科手术期间,通过切开口或通过如套针这样的检查口以内窥镜接近并仔细检查损伤。在每一种情况下,都非常希望进行仔细的检查,由于血管和神经网存在于典型损伤的区域内,因此,要求外科医生以非常熟练的技术且非常仔细地进行疝的修复。在该区域内能够发现脉管结构,如胃管,外部髂血管以及下位腹上部血管,以及生殖管道,如经腹股沟板伸出的输精管道。
在外科医生熟悉患者的解剖组织的情况下,外科医生要仔细地通过损伤处将内脏推送入患者腹部。对损伤的修复可包括利用缝合或紧固件使损伤闭合,但通常包括在开口的损伤处上方设置一外科假体件,如网状补片,并且利用常规的缝合或利用外科紧固件将网状补片固定至腹股沟板。网状补片起到阻挡层的作用并且能够防止内脏经损伤处排出。将网状补片缝合在腹股沟板上非常适于打开操作,但是在采用内窥镜的操作中难度非常大且会消耗大量时间。采用内窥镜的外科手术,可以使用应用外科紧固件的内窥镜外科手术器械。但是,当使用针或紧固件刺穿如库珀氏韧带这样的结构时,腹股沟板的组织可能会对外科医生提出特殊的挑战。
目前,存在各种适用于外科手术的外科器械和紧固件,以便在内窥镜或打开操作中用于将网状补片固定至腹股沟板上。最早使用的内窥镜外科器械为一种外科夹子切断机。通常,在一个夹子芯体内可以顺次装有多个未形成的夹子或夹子束,并且可通过一个弹簧机构使所述夹子或夹子束在器械内连续前进或输送。可采用辅助阀或输送机构使最远端的夹子从夹子束分离,以固定被弹簧加载的夹子束的剩余部分,并且可以将最远端的夹子送入夹子形成机构内。在Robert Rothfuss等人的美国专利No.5,470,010以及同样是Robert Rothfuss等人的美国专利No.5,582,616中披露了这种输送机构。
另一种疝网固定器械使用了一种类似一小部分弹簧的螺旋线紧固件。可以将许多螺旋线紧固件连续存放在5mm的轴内,并且可以使这些紧固件以螺旋状前进或转动进入组织内。可以使用一根加载弹簧,在轴内向远端偏压或输送多个螺旋线紧固件。一个凸起延伸进入轴内以便能够避免由加载弹簧排出紧固件束并可以允许一转动的紧固件通过。在Lee Bolduc等人的美国专利No.5,582,616和美国专利No.5,810,882以及Jeffrey Stein等人的美国专利No.5,830,221中披露了这些类型的器械和紧固件。
鉴于以上外科器械可用于疝紧固的用途,因此它们使用了一种弹簧机构来输送多个紧固件通过外科器械。弹簧机构通常使用一种较长且柔软的螺旋弹簧来推动一束紧固件通过外科器械轴内的导引件或吊轨。这些类型的输送机构通常是简单且可靠的,但是需要一个另外的辅助阀系机构或凸起,以从紧固件束分离一个紧固件并输送该紧固件。
可将其它类型的外科紧固件用于疝网的固定,但是要使用一种能固定少量紧固件的可重新装入的单发射击器械或旋转式料箱。在Edward Phillips的美国专利No.5,203,864和美国专利No.5,290,297中披露了这些类型的外科紧固器械。这些器械尚未被外科界接受,可能的原因在于它们的单发射击能力以及较大尺寸的旋转式料箱可能会限制这种器械用于打开操作中。
鉴于所有上面的外科器械可用于疝的固定用途,因此,它们或使用了一种弹簧机构来输送多个紧固件通过外科器械,或代替输送机构使用了一种旋转式料箱。可采用其它类型的外科紧固件,如外科夹片,并且这些紧固件可以利用无需使用弹簧的输送机构来向远端输送夹片。在Fogelberg等人的美国专利Nos.5,601,573,美国专利No.5,833,700和美国专利No.5,921,997中披露了一种往复输送机构。Fogelberg等人给出了一种夹片施用器的启示,该夹片施用器具有一个利用往复输送杆来输送一串夹片束缚的输送机构。输送发射导轨可操作地与向远端运动的输送杆接合并与其一起运动,并且可滑动地与向近端运动的输送杆接合。因此,输送发射导轨利用向远端运动的输送杆可向远端改变夹片束的位置或推动夹片束并且相对于向近端运动的输送杆保持静止。也可采用一阀系统以使最远端的夹片与夹片束分离并且当最远端的夹片应用于一根血管上时保持夹片束静止。虽然Fogelberg等人给出了一种具有一个往复运动件的往复输送机构的启示,但是他并未揭示在疝网的固定中使用夹片施用器,并且也未揭示利用一个运动件来单独驱动或输送每一个夹片。
在Klieman等人的美国专利No.4,325,376中披露了另一种利用往复运动的紧固件输送机构。该文献还披露了一种夹片料箱以连续形式存储多个夹片的夹片施用器。夹片呈束的形式,其中通过一个棘爪可向远端推动或输送最近端的夹片,所述棘爪在所述器械的每次起动期间,可由一个往复运动件或棘轮叶片啮合或向远端改变位置。当棘爪向远端转换位置时,其能够向远端推动夹片束。并且,还披露了一种辅助阀机构。因此,Klieman等人的输送机构揭示了利用一个往复运动件和棘爪而向远端推动或输送夹片束,并且可采用一个用以输送最远端夹片的辅助阀机构。
DeCarlo Jr.的美国专利No.3,740,994披露了一种新型往复运动输送机构,该机构可以转换许多夹子或夹片的位置,并且可以使它们为通过相对设置的片簧组件中的一个片簧往复运动而排出作好准备。夹子连续保存在一根具有一个固定片簧组件的导轨上,所述片簧组件伸入导轨的平面内。一往复运动的片簧组件可相对地朝固定片簧组件内延伸。当往复运动的片簧组件向远端运动时,该组件中每一个独立的片簧可接合一个夹子并使其向远端运动。向远端运动的多个夹子会使固定片簧组件中限制的独立片簧转向,并且在通过夹子后,转向的片簧可返回至未转向位置。当运动片簧组件向近端运动时,固定片簧组件的片簧使夹子保持静止并阻止其向远端的运动。可以设置一辅助导轨和阀机构,以为了成形一个夹子使其从夹子束上分离,并且在形成一个夹片时,可以保持夹子束静止。
另外,在Di Giovanni等人的美国专利No.4,478,220以及Menges等人的美国专利No.4,471,780中披露了类似的输送机构。这些相关专利均揭示了这样一种往复输送机构,该机构使用了一个固定件和一个往复运动件,目的是向远端输送多个夹片和转换这些夹片的位置。可以以铰接形式将倾斜的柔性指状件固定至往复运动件上并且当其向远端运动时,可操作地接合夹片,当其向近端运动时,可滑动地与接合夹片。当夹片向远端运动后,在固定件内的倾斜柔性指状件会偏离正轨,而在夹片已通过时,所述指状件会向上弹起以制止夹片向近端运动。并且还披露了一种辅助阀机构。
因此,Di Giovanni等人以及Menges等人的输送机构在一个往复运动件和一固定件之间,可操作地接合每一夹片并且使每一夹片单独向远端运动。但是,每一种器械均需要一种辅助阀机构,以便能输送和成形最远端夹片。
大部分上述输送机构需要两个输送机构;一个用以向远端输送多个夹片的主输送机构,以及一个辅助阀或输送机构,其用以分离和输送最远端的紧固件同时防止剩余紧固件向远端的运动。这类辅助机构造价较高并且会增大器械的尺寸或直径。同样,单发射击器或旋转料箱可能具有局限性。因此,需要提供一种改进的往复输送机构,该机构无需使用一辅助阀机构,并可同步接合每一个紧固件和独立向远端驱动每一个紧固件。这种机构可具有两个往复运动件并能够提供多个优点:如低成本,复杂性降低及具有较小直径的轴。
本发明的概述
根据本发明,提供了一种用于射出多个独立的外科紧固件的射出装置。所述射出装置包括:一个具有远端和近端的驱动机构。驱动机构具有一个运动部件和一个固定的相对部件,其中,运动部件可相对于射出装置向近端和远端运动。运动部件具有一个用于刺穿组织的锋利的末端。所述装置包括至少一个设置在第一和第二部件之间的外科紧固件。至少一个外科紧固件中的每一紧固件均具有一个近端和一个远端。所述装置还具有一个带有至少两个顺序位置的促动器。第一位置用于使运动部件向远端运动并刺穿组织,而第二位置用于使运动部件向近端运动,从而调度紧固件的远端。所述装置还包括这样一种机构,该机构在促动器已完全运动至其第一位置之前,在最初向第一位置运动之后,防止促动器向第二位置运动,而在促动器已完全运动至其第二位置之前,在最初向第二位置运动之后,防止促动器向第一位置运动。
附图的简要描述
在权利要求中对本发明的新特征进行了特别说明。但是,通过以下结合附图的说明会非常清楚地理解本发明本身,包括器结构和操作方法,以及其它目的和优点,其中:
图1为一种外科器械的等角图,其中,除去了左侧手柄半体以显示在扳机处于打开位置时其内部的元件,外科器械具有可从近端位置向远端位置运动的第一和第二滑动件;
图2为图1中外科器械的等角图,其中,使扳机从图1的打开位置运动至图示的关闭位置,以使第一和第二滑动件运动至远端位置,并且使固定至第一和第二滑动件的一个端部操纵装置从外科器械伸出;
图2B为图1的外科器械中一些内部元件的分解等角视图,这些部件包括第一和第二滑动件,并且为了清楚起见,除去了一些部件;
图3为图1中外科器械的第一侧的剖面侧视图,并且除去了左侧手柄半体,其中,如图所示,组装了所有的内部部件且扳机处于打开位置;
图4为图3中外科器械的第二侧的侧视图,其具有安装就位的左侧手柄半体并且除去了右侧手柄半体,该图显示了其中的所有内部部件并且扳机处于打开位置;
图5为图3中外科器械的第一侧的侧视图,其中,扳机移动至不完全关闭位置以使第一和第二滑动件不完全运动并且使端部操纵装置从外科器械不完全延伸;
图6为图5中外科器械的第二侧的侧视图,其中,扳机运动至不完全关闭的位置处以使端部操纵装置从外科器械伸出;
图7为图5中外科器械的第一侧的侧视图,其中,扳机运动至完全关闭的位置处以使固定至第一滑动件的端部操纵装置的第一部分缩入外科器械内,并且在端部操纵装置处露出一部分紧固件;
图8为图7中外科器械的第二侧的视图,其中,使扳机运动至完全关闭的位置处以使固定至第一滑动件的端部操纵装置的上部缩入外科器械内,并且在端部操纵装置处露出一部分紧固件;
图9为本发明中紧固件的等角视图,其中,紧固件具有一对远端倒钩以及一对较长的近端腿,所述紧固件如图所示,处于不受约束的状态;
图10为图9的侧视图,其中,本发明的紧固件如图所示,处于不受约束的状态;
图11为图9中紧固件的等角视图,其中,本发明的紧固件如图所示,处于在图1中外科器械内获得的约束状态;
图12为图11的侧视图,其中,本发明的紧固件如图所示,处于被约束的状态;
图13为图12的底视图,其中,本发明的紧固件如图所示,处于被约束状态;
图14为本发明中外科器械的轴的远端的剖面侧视图,其显示了在该处正常收缩的端部操纵装置以及在该处所含有的多个本发明的外科紧固件;
图15为图9中轴和端部操纵装置的剖面图10-10,并且其显示了一条通道以及在其中所含有的本发明的一个紧固件;
图16为外科抓紧器械的局部透视图,该器械在下腹部的腹股沟板(特别是在左侧腹股沟组织)中的缺陷或疝上方设有一网状补片;
图17为图16中下腹部的腹股沟板的剖面侧视图,其说明了根据本发明,在准备修复缺陷中,网状补片设置在组织上方;
图18为下腹部的腹股沟板的剖面侧视图,其中,图14中轴的远端将网状补片向下推动至腹股沟板上,并且端部操纵装置在其内部含有一个紧固件的轴中向下运动;
图19为图18中腹股沟板及器械的剖面侧视图,其中,本发明的端部操纵装置从轴伸出并且伸入腹股沟板内,端部操纵装置中装有一个理想发明形式的紧固件;
图20为图19中腹股沟板及器械的剖面侧视图,其中,端部操纵装置的第一部分局部缩入轴内,以调度其中所装有的理想发明形式的紧固件的第一倒钩并且使第一倒钩与腹股沟板接合。
图21为图20的剖面侧视图,其中,本发明中端部操作装置的第一部分完全缩入轴内,所述完全收缩释放了理想发明形式的紧固件的臂并使其进入轴中预先由端部操纵装置的第一部分占据的部分内;
图22为图21的剖面侧视图,其中,本发明中端部操作装置的第二部分完全缩入轴内,所述完全收缩使本发明紧固件的第二倒钩与腹股沟板接合还使两个臂与轴接合;
图23为图22的剖面侧视图,其中,图22中外科器械的轴已向上移动以释放本发明的紧固件的臂,所释放的臂将外科手术网固定至腹股沟板上;
图24为图1中本发明的扳机锁定机构的局部侧视图,其具有一个锁定臂,该锁定臂牢固固定在可绕枢轴转动的扳机上,并且可操作地与一锁定轮接合;
图25为本发明中锁定机构的局部剖面图,其显示了锁定轮处于起始位置并且与一轮爪接合,其中,锁定臂从开始位置(虚线)向上运动至与锁定轮相邻的第二位置(剖面);
图26为图25的局部剖面图,其显示了向上移动的锁定臂与锁定轮的第一齿接合,其中,所述接合已使锁定轮逆时针转动了一个齿并且锁定臂准备返回至起始位置(虚线);
图27为图26的局部剖面图,其显示了向上移动的锁定臂与锁定轮的最后一个齿接合,其中,扳机的往复发射已使锁定轮转动至最后的齿,并且一个锁定倒钩位于向上移动的锁定臂(剖面)的正下方;
图28为图27的局部剖面图,其显示了向上移动的锁定臂进一步与锁定轮的最后一个齿接合,其中,锁定轮已逆时针转动以使锁定倒钩位于锁定臂的下方;
图29为图28的局部剖面图,其显示了爪臂防止锁定轮的进一步转动并且锁定臂固定至锁定在一个齿和锁定轮的锁定臂之间的扳机上;
图30为本发明的可选择外科器械的等轴视图,其中,除去了左侧手柄半体以显示其内部的元件并且可选择外科器械具有一个固定滑动件,一个运动滑动件以及一个改进的锁定机构;
图31为图30的手柄的侧视图,其中,可选择扳机处于第一打开位置且运动和固定滑动件处于第一最近端位置;
图32为图31的手柄的侧视图,其具有运动至第二关闭位置的扳机以及运动至最远端位置的运动滑动件;
图33为图29中改进扳机锁定机构的局部等角视图,其具有一个锁定臂,该锁定臂牢固地固定至可绕枢轴运动的扳机上并可操作地与锁定轮相结合;
图34为可选择外科器械中轴的远端平面侧视图,其中,轴将疝网推靠在组织上并且显示了之间装有多个外科紧固件的运动和固定滑动件的位置;
图35为图34中腹股沟板和轴的剖面侧视图,其中,运动滑动件和可选择发明的固定端部操纵装置从轴伸出且伸入疝网和腹股沟板内,所述端部操纵装置在其中装有一个理想发明的紧固件;
图36为图35中腹股沟板和轴的剖面侧视图,其中,可选择外科器械的滑动件和固定式端部操纵装置完全缩入轴内,完全收缩释放了紧固件的倒钩并使其进入腹股沟板的组织内;
图37为图36的剖面侧视图,其中,可选择外科器械的轴向上运动,以便从轴中释放紧固件的一对腿,被释放的腿将外科手术网固定在腹股沟板上。
对本发明的详细描述
本发明通常涉及一种外科器械,更特别涉及一种具有一个输送机构的外科器械,该机构用于从外科器械逐次输送至少一个外科紧固件,以在对组织中的缺陷(如腹股沟疝)的修复中固定一个假体。
例如,结合腹股沟疝的修复对本发明进行了说明和描述。但是,应理解本发明可适用于各种需要修复组织中缺陷的其它外科手术操作。
外科器械
如在图1和2中能最清楚地看到的那样,本发明的外科器械或紧固件射出装置包括一个手持外科器械35,其含有多个外科紧固件或外科部件,这些外科紧固件或外科部件通常用于将一个假体固定至组织上,或作为组织标记器。本发明的外科紧固件105可由一种超弹性镍钛合金制成,可以以压缩状态或叠并状态存放在外科器械内,并且在从外科器械释放时可以膨胀至不约束状态。器械的起动能够从器械的远端同步释放本发明的一个紧固件105并且可转换器械内多个紧固件105的位置。
本发明的外科器械35具有一个手柄40,一个从手柄40向远端伸出的细长轴92以及一个从手柄40向下延伸的扳机85。手柄40具有一个右侧半体41和一个左侧半体42,这两个半体彼此大致呈镜像设置,并且在图1和2中,省略了左侧半体42。细长轴92可以牢固地固定至手柄40上,并且细长轴92可由一种刚性空心材料(如不锈钢管件)形成。可以将一个把手43牢固地固定在手柄40的近端并且该把手从手柄40的近端向下延伸且与扳机85相邻。扳机85可绕枢轴转动地安装在手柄40内并可以从图1所示的打开位置运动至图2所示的与把手43相邻的关闭位置处。扳机85向关闭位置的运动能够使一端部操纵装置95从轴92的远端(图2)伸出,以便设置并释放一个紧固件。
图2B为在外科器械35内获得的大部分元件的等角分解视图。该分解视图用于使读者熟悉其中所装有的关键性元件和用于形成外科器械35组装的方法。为了清楚起见,可以除去多个部件,如左侧手柄半体42。图2B中的一些部件形状较为复杂且可建议读者返回该附图以便识别或理解以参考说明的特征。外科器械35的部件可以装在右侧和左侧手柄半体41,42内,右侧和左侧手柄半体可以由工程热塑料(如苯乙烯,聚碳酸酯),或多种适合材料中的任意一种制成。可以在手柄半体41,42上部的远端设置一个轴槽44,以便能够在其中接收并固定轴92。
锁定槽45可以紧靠右侧手柄半体41内的轴槽44设置并位于该轴槽的下方。锁定槽45可以为直角形状且可以确保在其中接收锁钩55。锁钩55可具有一根在远端处的刚性锁钩杆57以及一个从该处向远端延伸的直角梁56。梁56可由一种如不锈钢这样的弹性弹簧材料构成。可以锁定梁56的远端并以梁56从该处以悬臂形式充分伸出的方式将其固定在锁定槽45内。当梁56偏转时,梁56的悬臂部分能够使锁钩杆57自由向上和向下运动。在后面将对锁钩55的重要性加以说明。
第一和第二滑动件60,70可以为相对设置的元件,这些元件大致通过外科器械35的轴92和手柄40、向近端和远端延伸并形成一种用于紧固件105的驱动机构。第一和第二滑动件60,70可相对于外科器械35、彼此相对独立地向近端和远端运动,并且可以将所述第一和第二滑动件可滑动地保持在设置于每一手柄半体41,42内的一对导槽46内。在图2B中,第一和第二滑动件60,70具有近端和远端并如图所示,在组装前是分离的,以便显示出存放在它们之间的多个紧固件105。紧固件105可沿第一和第二滑动件60,70的整个长度延伸。第一和第二滑动件60,70具有可滑动地安装在轴92内的远端第一和第二供料件61,71,并且具有较大的近端侧第一和第二程序设定件62,72,所述第一和第二程序设定件可滑动地安装在手柄半体41,42内。第一和第二供料件61,71可采用半圆形剖面且可具有第一和第二外表面64,74。一对第一和第二刺穿杆64a,74a可分别从每一第一和第二外表面64,74的远端向外延伸。第一和第二接触面63,73可以分别形成第一和第二供料件61,71的半圆形剖面。第一和第二接触面63,73沿第一和第二滑动件60,70的整个长度彼此相对且具有在其中延伸的第一和第二紧固件通道65,75。在组装时,第一和第二滑动件60,70能够沿第一和第二接触面63,73的整个长度形成滑动接触,且第一和第二紧固件通道65,75可以形成一个空心矩形通道,以便通过该处顺次固定并输送紧固件105(图15)。
第一和第二滑动件60,70的紧固件通道65,75可采用“U”形形状,以便在其中接收紧固件105并且还具有一对相对设置的内表面或通道板,以便与紧固件105接合。所述内表面可具有多个凸起或紧固件驱动件,这些凸起或紧固件驱动件在内表面上留有间隔,以便与紧固件105接合。如能够在图14中最清楚地看到的那样,这些凸起或锯齿120沿第一和第二紧固件通道65,75底板的整个长度由近端向远端延伸,且可相距相等的纵向间隔“D”。间隔“D”可以在8英寸至0.05英寸之间。本发明的间隔“D”可以为4.75英寸。间隔“D”可以使紧固件彼此分离,以便在外科器械35内输送紧固件时,紧固件不会接合或碰撞。如图所示,每一锯齿120均具有一个近端斜面122和一个远端台阶121。在后面将对在紧固件105输送中锯齿120的作用进行说明。
第一和第二紧固件导引件66,76可分别设置在第一和第二紧固件通道65,75的远端,这些导引件可以在紧固件通道65,75的近端形成锥形引入端,从而有助于在其中装载紧固件105。这些紧固导引件66,76可彼此大致呈镜像设置。在图2B中,隐藏了第一紧固件导引件66。
第一和第二滑动件60,70的较大近端部分为第一和第二程序设定件62,72,这些程序设定件可以控制紧固件输送机构的定时和次序,该紧固件输送机构能够从器械的远端释放一个紧固件,并且在器械内向远端改变多个紧固件的位置或输送这些紧固件。第一程序设定件62可具有一对从任意一侧向外横向延伸的导引肋68,以及一个在近端处向上延伸的第一弹簧止动件67。导引肋68可以安装在右侧和左侧手柄半体41,42的导引槽46内且可滑动地将组装后的滑动件60,70固定在手柄40内。一对“C”形导引件通道69可设置在第一程序设定件62的近端半体的下方并且沿该近端半体纵向延伸。第二程序设定件72可具有位于第二程序设定件72近端的第二弹簧止动件77以及一个在远端向上延伸的叉形止动件78。凸轮盘79向外从第二程序设定件72的远侧朝右侧手柄半体41延伸。一对滑动件肋83沿第二程序设定件72的近端半体横向向外延伸。第一和第二滑动件60,70可形成一个由工程热塑料(如液晶聚合物,聚碳酸酯,尼龙,苯乙烯或类似材料)制成的单体件。
通过将设置在第二程序设定件72上的成对滑动件83插入第一程序设定件62的成对导引通道69内,可以将第一和第二滑动件60,70相互锁定在一起。第一和第二滑动件60,70通过在其上固定刺穿件或第一和第二倒钩板96,97,可以形成尖利的形状。随后,通过在第一和第二刺穿杆64a,74a上方设置第一和第二倒钩板96,97并且随后使组装成的倒钩板96,97和第一和第二滑动件60,70设置在空心轴92内以形成轴的副组件,可以使第一和第二倒钩板96,97固定至第一和第二滑动件60,70上。在图14中能够最清楚地看到倒钩板保持的方法。倒钩板96,97可用于在将紧固件105设置在组织内期间刺穿组织并且可由如不锈钢这样的刚性材料形成。
接着,可以将轴的副组件设置在一紧固件输送站(未示出)内,并且可以每次将一个紧固件105送入第一和第二紧固件导引件66,76内并且送入由紧固件通道65,75形成的空心通道内。可以插入紧固件105,直至紧固件105与输送机构接合,在后面将对其进行说明。一旦紧固件105就位,可以使第一和第二滑动件60,70彼此相对近端和远端往复运动,以进一步改变紧固件105的位置或将紧固件105送入轴的副组件内。对于每一新的紧固件105而言,这种过程可反复进行,直至第一和第二滑动件60,70以连续方式加满了多个紧固件105。多个紧固件105沿第一和第二滑动件60,70的整个长度有间隔相等的距离。随后,可以将装有紧固件105的轴的副组件设置在右侧轴半体41内。可以在轴槽44内接收轴92并且第一滑动件60的导引肋68可滑动地设置在轴槽46内。接着,可以在紧邻枢轴孔47的位置处,将锁定轮100设置在位于右侧手柄半体41内的一个轮接收件48内。
通过将一扳机板87和一锁定臂88设置在一扳机85的任一侧横向延伸的枢轴86上,并且通过一对销89牢固地将它们固定在扳机85上,可以构成扳机组件。一驱动臂90可以从扳机板87向上延伸且一弹性杆91从扳机板87的远侧朝右侧手柄半体41延伸。随后,将扳机弹簧104的一端(图3)设置在弹簧杆91上面。随后,通过将远侧枢轴86(未示出)设置在一枢轴孔47内,可以将扳机组件设置在右侧手柄半体41内。扳机85,扳机板87以及锁定臂88如图所示,为独立部件,但是作为可以选择的方案,可以使它们构成由工程热塑料(如聚碳酸酯,苯乙烯或类似材料)制成的整体件。
图3显示了手柄40中完全组装后的部件。在图3所示的视图之前,已使扳机弹簧104的自由端延伸并使其固定至把手43的一个弹簧销49上。扳机弹簧104自由端的固定使扳机弹簧104拉伸,并将扳机85偏压至所示的打开位置。接着,可以压缩第一复位弹簧115并使该弹簧设置于在第一滑动件60的第一弹簧止动件67和手柄半体41,42的第一弹簧肋50之间形成的第一弹簧槽内。也可以压缩第二复位弹簧116并使该弹簧设置于在第二滑动件70的第二弹簧止动件77和第二弹簧肋51之间形成的第二弹簧槽内。最后,可以将左侧手柄半体42固定至右侧手柄半体41上,以完成外科器械35的组装。为了清楚起见,已除去了左侧手柄半体42。
促动器机构
图3-8的器械显示了能够控制外科器械35内的元件定时和运动的促动器或程序设定机构的操作。通过驱动扳机85能够接合促动器机构并使驱动机构或第一和第二滑动件60,70进入至少三个顺序位置。扳机85的驱动能够同时使第一和第二滑动件60,70从第一近端位置向远端运动至第二远端位置,随后使第一滑动件60返回所述近端位置,并最终使第二滑动件70返回近端位置。这种顺序的运动能够使多个紧固件105向远端运动,并使紧固件的末端以两步进入组织内。促动器机构可由锁钩55,上述扳机组件,第一和第二复位弹簧115,116以及第一和第一滑动件60,70构成。
图3显示了图1中外科器械的第一或左侧视图,其具有安装就位的右侧手柄半体41,为了清楚起见,除去了左侧手柄半体42,并且扳机85处于其最初的打开位置。第一和第二滑动件和第二复位弹簧115,116能够在手柄41,42内向远端偏压第一和第二滑动件60,70。扳机组件中的扳机85可以处于完全打开的位置,同时驱动臂90做好可操作地接合第一程序设定件62的导引肋68近端的准备。第一和第二滑动件60,70处于第一近端位置。
图4显示了图3中外科器械的第二或右侧视图,其具有安装就位的左侧手柄半体42以及被除去的右侧手柄半体41。锁钩55在该视图中是可以看到的,并且锁钩55的锁钩杆57可操纵地与位于第一程序设定件62末端上的第一斜面69a接合。为了清楚起见,以剖面形式显示了第一和第二弹簧肋50,51的一部分以及右侧手柄半体41的锁定槽45。
图5和6分别显示了装配好的外科器械35的左侧和右侧视图,并且显示了通过扳机85可以使第一和第二滑动件60,70远离图3-4的第一位置向第二位置平移或运动。第一和第二滑动件60,70的远离运动可以使端部操纵装置95从轴92的远端延伸。扳机85处于第一局部关闭位置且可以为从扳机组件的驱动臂90释放第一滑动件60作好准备。
在图5中,当扳机85朝把手43逆时针转动时,驱动臂90能够转动至与导引肋68接合并使第一滑动件60向远端运动。当第一滑动件60向远端运动时,可以接触第二滑动件70的叉形止动件78,从而推动第二滑动件70向远端运动。如图所示,使第一和第二滑动件60,70向远端运动能够压缩第一和第二复位弹簧115,116。扳机组件的锁定臂88向上运动,从而能够使锁定轮100转动。
在图6中,当第一和第二滑动件60,70向远端运动时,它们可以使锁钩55的锁钩杆57向下偏转,以沿第一滑动件60的第一斜面69a和第二滑动件70的第二斜面80滑动。锁钩55的锁钩杆57可以通过第二斜面80并向上偏转以锁定在第二滑动件70的第三斜面81以及第一程序设定件62的底面62a上。在锁钩55处于该位置的情况下,可以使第二滑动件70锁定在远端位置处且第二滑动件70不能向近端运动。
图7和8分别显示了在第一滑动件60已往复或返回图3和4的第一近端位置以从端部操纵装置95局部释放一紧固件105后,组装好的外科器械35的左侧和右测视图。
如图7所示,在可以从驱动臂90释放导引肋68之后,第一滑动件60从图5和6所示的第二远端位置向远处互换运动至第一近端位置。通过第一复位弹簧115可以使滑动件60返回近端位置。如图所示,第一滑动件60的近端运动能够使第一刺穿板96向近端缩入轴92内并释放紧固件105的远端。锁定臂88能够从锁定轮100向上运动并与其分离。
在图8中,当第一程序设定件62向近端运动时,第一程序设定件62的底部表面62a可向远端运动从而离开能够使锁钩55向上朝图3所示的非偏转位置偏转的锁钩杆57。这种运动能够释放第二程序设定件72。在松开第二程序设定件72的情况下,被压缩的第二复位弹簧116可以使第二滑动件70返回图3的初始近端位置。当第二滑动件70互换返回第一近端位置时,通过凸轮盘79的第三斜面81可以使锁钩杆57向上偏转,以越过向远端运动的凸轮盘79的顶面82并返回图3的位置。此时,如果未起动器械的锁定,则可以释放扳机85以使器械的元件返回至图3所示的位置。
紧固件
图9-13为显示本发明中新型外科元件,锚固件或紧固件105的分解视图。本发明的多个紧固件105顺次安装在外科器械35(图2B)内且用于将如外科手术用网垫这样的修复物固定或缝合在组织上。本发明的紧固件105可具有弹性且如图所示处于图9和10中的初始不受约束的状态。当紧固件105可变形或可被约束时,在释放时其将恢复至其初始形状。紧固件105由假弹性或超弹性镍合金片或箔形成或模压而成,以便利用其假弹性或超弹性特性,或由弹性级钢,不锈钢,铜或其它镍合金制成。
最理想的是,紧固件105可由一种包括大约50.5%(此处所用的这些百分比是指原子百分率)的Ni至60%的Ni的合金制成,最好为55%的Ni,合金的剩余部分为Ti。紧固件优选在体温下具有超弹性,最好在大约15℃至大约37℃的范围内具有Af。紧固件105的超弹性设计能够使其在压扁后可以复原,其能够使较大的紧固件105保存在较小直径的轴92内。
如上面所提到的那样,本发明的紧固件105可由一种超弹性合金制成,且可由一种具有大于50.5%(原子百分比)的镍以及剩余部分为钛的合金制成。大于50.5%(原子百分比)的镍允许采用这样一种合金,其中,马氏体相完全转变为奥氏体的温度(Af温度)可以低于人体温度且可以为大约15℃至大约37℃,以便奥氏体在体温下即成为最适当的相。
图9和10中不受约束的紧固件105具有一个大致平面状连续主体件109,其具有一第一(远)端以及一个第二(近)端。至少一个倒钩能够从远端伸出,且至少两个倒钩从近端伸出。连续的主体件109具有可以是圆头或钝头的远端106。作为可选择的方案,如果希望,可以将紧固件105的远端106制成锋利或尖头状。第一和第二倒钩107,108可以沿轴向离开远端106和离开主体件109向近端延伸。第一和第二倒钩107,108可以是弯曲的。主体件109的远端可以为一对倒钩或第一和第二腿110,111,这对倒钩或第一和第二腿远离主体件109且以不同的方向彼此分离延伸。本发明的第一和第二腿110,111可以接合第一和第二部件60,70的内表面,也可以从主体件109向外弯曲,且可以形成图9和10的外翻结构f。第一和第二倒钩107,108以及第一和第二腿110,111的端部可以是钝头状。
图11-13显示了本发明中紧固件105的等角视图,侧视图以及底视图,其中,紧固件105如图所示,处于紧固件105存放在外科器械35内时所能呈现的被约束状态(图1)。当从外科器械35被释放时,紧固件105能够恢复至图9和10的不受约束的状态。当设置在组织内时,外科紧固件105也能够用作一个标记器,即,紧固件105的材料应保证其可以在诊断检查(MRI扫描,CAT扫描,X-射线或超声波)时显现出,并且外科医生能够容易地识别紧固件相对于另一主体特征的位置。
驱动机构
图14和15为图3中轴92的远端的放大局部剖面图,其显示了在第一或未启动位置处的第一和第二滑动件60,70或移动梁,其中,嵌入轴92内,并且在它们之间装有紧固件105。在第一远端位置处,外科器械35的扳机85可完全打开(图3)且第一滑动件60的锯齿120可与第二滑动件70内的锯齿120对齐并与锯齿120正对。图15显示了第一和第二紧固件通道65,75能够形成一个用于在其中接收紧固件105的通道。
驱动机构使用了自身的紧固件105作为一部分驱动机构。如图14所示,驱动机构59可具有三个截然不同的元件:第一元件或滑动件60,第二元件或滑动件70以及以串联方式存储在其间的多个紧固件105。紧固件105可固定在锯齿120之间,并且倒钩107,108向外偏转以使紧固件105在锯齿120之间对中。第一和第二腿110,111可向外偏压紧固件105,从而使它们以所示的角度接触锯齿120的表面。如果使紧固件120相对于第一或第二滑动件向近端运动,则接触第一和第二滑动件60,70的腿110,111的角部能够插入并极力向外膨胀抵靠在锯齿上。同样,腿的远端能够与锯齿120的台阶121形成可靠的接触。在第一和第二滑动件60,70内的紧固件向远端的运动能够使腿110,111的角部沿斜面122滑动。另外,倒钩107,108的角部接触斜面122,并且在它们接触第一和第二滑动件60,70时,能够与腿110,111以不同的方式起作用。第一和第二滑动件60,70的远端如图所示,在台阶121和斜面122的接合处位于槽内,且可操作地与台阶121接合并且可滑动地与斜面122接合。紧固件与台阶121的可靠接触或接合以及与斜面122的滑动接触或接合能够在往复运动的第一和第二滑动件60,70之间驱动或输送多个紧固件105并将紧固件105设置在组织内。因此,倒钩107,108以及腿110,111均能够推动紧固件。
可以理解:若给定了上述驱动机构59的部件,第一和第二滑动件60,70均向远端的运动能够使紧固件105与两个滑动件60,70的台阶121可操作地接合。这种与向远端运动的滑动件60,70的可操作接合能够形成紧固件105向远端的运动。如果滑动件中的一个(如第一滑动件60)向远端运动,同时另一个保持固定,则紧固件105可操作地与运动的滑动件60结合且与其一起运动,同时与固定的滑动件70滑动接合。并且,如果滑动件中的一个(如第一滑动件60)向近端运动,同时另一个保持固定,那么紧固件105可操作地与运动的滑动件70结合且保持固定,并与运动的滑动件60滑动接合。
通过上述运动和反应的结合,存在三种通过向远端驱动紧固件105通过外科器械35的滑动件60,70实现的不同顺序的运动(图3)。当可以将紧固件105设置在组织中时,可以选择这些运动中的一种与外科器械35一起使用。利用驱动机构59的这种驱动顺序如图所示,以步进方式由图14所示的起始位置开始,并结束于图18-22。其它的两种顺序将在后面进行描述。
本发明的促动器机构可具有至少三个连续位置。首先,促动器机构可使第一和第二滑动件60,70(图18,19)从第一近端位置(图14)向远端朝第二远端位置(图19)运动。这种运动能够可靠地使紧固件105与第一和第二滑动件60,70接合并使紧固件105从第一位置向远端朝第二位置运动。使第一和第二滑动件60,70(图14)从第一近端位置朝第二远端位置的运动能够使所有多个紧固件105在外科器械35内向远端运动。即,此时每一紧固件105(除最远端的紧固件105以外)可占据前面的紧固件105的位置。
接着,如图20,21所示,促动器机构能够使第一滑动件60从第二远端位置运动或互换返回至第一近端位置,以使第一和第二滑动件60,70的锯齿120相对对准。如图所示,紧固件105可操作地与固定第二滑动件70接合且在轴92内保持静止(纵向)。
最后,如图22所示,促动器机构可以使第二滑动件70从第二远端位置向近端运动或返回至第一近端位置,且可以使第一和第二滑动件60,70内的锯齿120重新定位。紧固件105能够可操作地与静止的第一滑动件60啮合且保持静止,并与向远端运动的第二滑动件70形成滑动接触。如图22所示,第一和第二滑动件60,70能够将最远端的紧固件105设置在组织内且能够向远端运动返回至第一位置。一个新的紧固件105如图所示,位于第一和第二滑动件60,70内,以便为设置在组织内作好准备。
如上所述,本发明存在另两个的实施例,其中,通过第一和第二滑动件60,70可以实现不同顺序的运动。这些运动的可选择顺序也向远端驱动紧固件105通过外科器械35(图3)。
在下一个或第二实施例中,运动的顺序将可以固定第一或第二滑动件中的一个(如第一滑动件60)并使剩余的滑动件70向远端从第一位置朝第二位置运动并返回至第一位置。在第三实施例中,可以改变运动的顺序,其中,使第一和第二滑动件60,70同时以相反的方向往复运动。
图30-37显示了本发明中另一种外科器械235,其使用了上述驱动机构的第二实施例,其中,一个滑动件可以是固定的,而一个滑动件可以往复运动或移动以驱动紧固件105向远端通过所述另一种外科器械235。一个运动滑动件和一个固定滑动件之间的相对运动能够使紧固件105向远端运动,并且任一个滑动件均可以是运动滑动件,只要剩余的滑动件是固定式即可。为了避免与如滑动件60,70这样的前面所述的部件发生干涉,改变另一种输送机构259内的部件以使其具有新的部件数量并在需要之处对它们进行说明。例如,将上侧滑动件称为运动滑动件260,而将下侧滑动件称为固定滑动件270。在外科器械的任意实施例中可以代替使用的紧固件105和其它部件将采用相同的部件标号。因此,所述另一种输送机构259可具有三种特殊的部件:运动滑动件260,固定滑动件270以及多个以顺次方式存储在运动滑动件和固定滑动件之间的通道(图34-37)中的紧固件105。由于运动和顺序的差异,因此,另一种输送机构259则要求采用一些辅助机械差异和紧固件的布置方法。下面将对这些差异进行说明。
图30-32显示了可选择外科器械235中可选择手柄240及其部件。为了清楚起见,已省略了可选择手柄240的左侧可选择手柄半体242(即,未在图中示出),以便能够看到部件在右侧手柄半体241内的布置和运动。图34-37显示了当紧固件105应用于组织以将疝网固定至组织上时,滑动件和其它部件在可选择的外科器械235远端的运动。图33显示了一种扳机锁定机构的另一实施例。
在图30-32中,可以使运动滑动件260位于右侧可选择滑动件半体241中的固定滑动件270的上方且运动滑动件可以径向伸入从可选择手柄240的远端伸出的管92内。第一复位弹簧115可以通过推靠在运动滑动件260的运动弹簧止动件267上而向近端朝图30-31所示的位置偏压运动滑动件260。通过一个可旋转地安装在可选择手柄240内的可选择扳机285,运动滑动件260可以在可选择外科器械235内向远端运动。可选择扳机285可以绕一对相对设置的可选择枢轴286转动,以使一个可选择驱动臂287与从运动滑动件260向外延伸的导引肋268接触。可选择扳机285从第一打开位置(图30-31)向第二关闭位置(图32)的运动能够使运动滑动件260和紧固件105从图30-31所示的最近端位置向图32所示的最远端位置运动。这种运动可以压缩右侧可选择手柄241之间的第一复位弹簧115并拉伸固定至可选择扳机285以及右侧可选择手柄241的扳机复位弹簧104(图32)。可选择扳机285从第二关闭位置的释放允许使压缩的第一复位弹簧115使运动滑动件260返回至最近端位置并允许扳机弹簧104使可选择扳机285返回至第一打开位置。一固定止动件277可以从固定滑动件270的近端向下延伸。可以将固定止动件277锁定在右侧可选择手柄半体241的狭槽250内,并且该固定止动件277能够充分约束固定滑动件270向近端和向远端的运动,从而“固定”固定滑动件270。
调控器215可以被牢固地固定至滑动件260上的调控器座264上并在可选择扳机285从第一打开位置运动至第二关闭位置时,能确保所述可选择扳机285的单向运动。一旦可选择扳机285完全关闭,调控器215可重新设定并在可选择扳机285从第二关闭位置返回完全打开的位置时能确保实现可选择扳机285的单向运动。调控器215的动作能够确保运动滑动件260相对于固定滑动件270的整个向近端和向远端的往复运动以及紧固件105在其之间的前移。调控器215可以是弹簧且可具有调控器叶片216,这些叶片从调控器215的近端向外横向延伸,以可操作地与从可选择手柄240向内延伸的至少一个调控器齿条244啮合。调控器齿条244可以是塑料手柄半体241,242的向内延伸件,或可以是牢固固定至可选择手柄240的一个或多个部件。一种方案可以将调控器看作是这样一种机构,该机构在促动器已完全运动至其第一位置之前,在其最初向第一位置运动之后,能够阻止促动器向第二位置运动,并且在促动器已完全运动至其第二位置之前,在其最初向第二位置运动之后,能够阻止促动器向第一位置运动。
在图31中,调控器215显示了向上偏转且位于调控器齿条244的下方。当使可选择扳机285从图31的第一打开位置朝图32的第二关闭位置运动时,通过调控器齿条244可以使调控器215向远端运动并向下偏转。这种运动能够使调控器叶片216的上缘与齿条锯齿247的下侧齿条245接触。可以对齿条锯齿247进行定位,以在运动滑动件260和紧固件105的整个向远端前进期间,确保与调控器叶片216形成单向滑动接合,并且如果通过打开可选择扳机285使运动滑动件260向近端运动,则可以提供锁定接合。如图32所示,可选择扳机285完全关闭且通过从下侧齿条245的下方滑出,可向上重新设置调控器215。当可选择扳机285从关闭位置恢复至打开位置时,运动滑动件260可以向近端运动,以使调控器叶片216的下缘与调控器齿条的上侧锯齿246啮合。可以对上侧齿条246的齿条锯齿247进行定位,以在可选择扳机285从关闭位置运动至打开位置时,确保向调控器叶片216提供单向滑动动作,并且如果可选择扳机285朝关闭位置向后运动,则可以提供锁定接合。调控器齿条244可以是塑料手柄240的向内延伸件,或可以是由如金属或塑料这样的备用材料形成的副件。
解剖模型
参见图16,本发明的外科器械的一种典型应用可以为对损伤,如位于腹股沟组织(腹股沟板126)处的腹股沟疝125进行修复。对患者左侧解剖组织的解剖结构进行说明,以便指出本发明的用途。
通常,经髂肌127可以接近腹股沟疝125。如所清楚理解的那样,血管和神经网存在于典型腹股沟疝125的区域中,因此其要求外科医生利用非常娴熟的技术并且非常谨慎地进行疝的修复。例如,在横向腹腱膜128中,内环129允许胃血管130以及输精管道131经该处延伸遍布腹股沟韧带132的边缘。股管133位于库珀氏韧带134附近且包含外部髂血管135以及次腹上部血管136。
在许多情况下,腹股沟韧带132的边缘以及库珀氏韧带134起到了解剖标记的作用以及能支承外科紧固件(如那些以前提到的紧固件)的支承构件。对于外科医生而言,含有外部髂血管135和输精管道131的区域通常被称为“死亡三角区”。因此,外科医生必须避免损伤上面提到的这些血管中的任何血管且在该区域内进行解剖,缝合或固定时必须倍加小心。
在图16和17中,作为在修复腹股沟疝125中的第一步,可利用外科抓紧器械145将一假体或网状补片140设置在腹股沟疝125上方。网状补片140可以采用任意理想的形状,结构或材料。但是,网状补片140最好由PROLENETM(一种由纤维制成的已知聚合物)制成并且结构最好采用网状。由于易于给定网状补片140的尺寸,如提供一侧部狭槽141,以便容纳胃血管130以及输精管道131,因此在外科医生熟练和舒适的区域内可利用PROLENETM网状补片140。
如所说明的那样,可以将网状补片140设置在腹股沟疝125的上方,以便对下腹部的内脏(未示出)提供充分的阻挡层,否则内脏会产生经腹股沟疝125伸出的趋势并使患者产生很大的痛苦和不舒适性。图17显示了设置在腹股沟板126上的网状补片140的侧视图。此时,网状补片140可以固定至腹股沟板126上。
方法
图18-23也用于说明外科器械35的利用方法。轴92远端的这些剖面侧视图显示了在将本发明的新型紧固件105设置在腹股沟板126内以将网状补片140固定至该处时,再利用外科器械35中所含的步骤。
图18为下腹部的腹股沟板126的侧视图,其中,外科医生已将轴92的远端设置在位于患者腹股沟疝125附近的区域内。外科医生选择了一个固定点或外科手术位置并利用外科器械35的远端向下将网状补片140推至腹股沟板126上。可以仔细地将轴92的远端设置在网状补片140内的开孔142的上方,以便经该处设置紧固件105。在剖面所示的轴92内的端部操纵装置95的位置表明外科医生已部分起动了扳机85。扳机85的部分运动或驱动能够使第一和第二滑动件60,70从图14所示的起始位置向远端(在图18中向下)运动。
如图19所示,外科医生继续使扳机85向第一位置(图2,5和6)驱动或运动,且使端部操纵装置95的第一和第二滑动件60,70从轴92充分延伸或运动。伸出的端部操纵装置95经网状补片140内的开孔142进入腹股沟板126内。虽然通过端部操纵装置95不会与组织接触,但是,远端紧固件105的第一和第二倒钩107,108却设置在腹股沟板126的组织内。
通过外科医生进行扳机85的持续驱动使扳机85从图5和6所示的第一不完全闭合位置运动至图7和8所示的第二完全闭合位置。在该位置处,可以驱动外科器械35的指示机构并且驱动的自动顺序由图20中箭头所示的第一滑动件60向近端的往复运动或移动开始。
在图20中,第一滑动件60已部分运动或缩入轴92内,这种驱动可以从图19所示的约束状态释放最远端紧固件105的第一和第二倒钩107,108并使第一倒钩107与腹股沟板126的组织牢固接合。当释放时,远端紧固件105的倒钩107,108能够相对于图20所示的位置突然打开,从而使最远端紧固件105弯曲。
一旦被驱动,第一滑动件60则能够持续向远端运动进入外科器械35内,直至其返回轴92内的起始开始位置,如图21所示。当第一滑动件60处于该位置时,如箭头所示,可以自动释放第二滑动件70,以向远端运动或互换至轴92内。
如图21所示,第一滑动件60处于图15的起始开始位置,并能够完全释放远端紧固件105。第二倒钩108和第二腿111可以将远端紧固件105偏压入预先由第一滑动件60的第一供料件61占据的轴92的部分。这种偏压还能够使远端紧固件105的第一倒钩107与腹股沟板126接合。
在图22中,第二滑动件70自动向远端缩入轴92内并到达第一起始位置且能完全释放远端紧固件105的第二倒钩108,以与腹股沟板126的组织接合。可以从第二滑动件70释放远端紧固件105的第二腿111并且第一和第二腿110,111能够在轴92内向外膨胀。
最后,外科医生可以释放扳机85,该扳机85返回图1的起始打开位置并拉动轴92的远端离开网状补片140和接合或固定至腹股沟板126的远端紧固件105。如图23所示,使本发明的紧固件105的第一和第二倒钩107,108牢固地扎入腹股沟板126内并且随后第一和第二腿110,111可从轴92释放,急速返回它们的原始倒置形状(图9和10)。通过紧固件105的第一和第二腿110,111可以使网状补片140牢固地固定在腹股沟板126上。此时,外科器械易于将网状补片140固定在另一个位置处。为了实现这一情况,外科医生仅需将轴92的远端重新设置在另一外科手术位置处并驱动扳机85以将另一紧固件105设置或固定在腹股沟板126内。这种过程可持续进行,直至令人满意地将网状补片140固定至腹股沟板126。
图34-37说明了当利用一紧固件105将一网状补片140固定至腹股沟板126时,可选择外科器械235的使用方法。与具有两个运动滑动件60,70的以前描述的外科器械不同,可选择的外科器械235可具有一个运动滑动件260以及一个固定式滑动件270。该外科器械可利用一种不同的顺序或运动方法将紧固件105设置在组织内。以前所述的滑动件60,70可具有内部紧固件通道65,75(图2B)以推动紧固件105通过外科器械35。运动和固定滑动件260,270可采用相同的原理并在运动滑动件260中具有一个运动通道265且在固定滑动件270中具有一个固定通道275。与前面所述的通道65,75相同,运动和固定式通道265,275也具有带有台阶121和斜面122的锯齿120。在可选择外科器械235中,台阶121之间的纵向距离为外科器械35中的一半,而往复行程的长度可以保持与外科器械35中的行程大致相等。因此,在任一外科器械35,235中,可以使紧固件105大致向远端运动相等的距离。但是,在可选择外科器械235中,当从图34的位置运动至图35的位置时,可以使紧固件105的第二腿111向远端运动两个锯齿,如由最远端紧固件105所示。
图34显示了下腹部中腹股沟板126的剖面侧视图,其中,外科医生可以利用可选择外科器械235的轴92的远端来向下推动网状补片140抵靠在腹股沟板126上。可以仔细地将轴92的远端设置在网状补片140内的开孔142的上方,以便通过该处设置紧固件105。可选择的外科器械285处于第一打开位置(图31)处且运动滑动件260可位于最近端位置处。相对于轴92固定固定式滑动件270,且运动滑动件260可随时准备向远端推动紧固件105并将最远端紧固件105(在底部所示)推入组织内。紧固件105的第二腿111可与固定滑动件270的一个台阶121接触。如图所示,运动滑动件260向远端(向下)的少量运动可以使运动滑动件260的一个台阶121与紧固件105的第一腿部110接触。可以将一块运动刺穿板296牢固地固定在运动滑动件260上,并且在图35中能够最清楚地看到。运动刺穿板296可以是一具有台阶的圆筒,其设有两个具有不同直径的部分,即一个具有较大直径的近端部分且可牢固地固定在运动滑动件260上,以及一个从该处向远端延伸的小直径远端部分298。远端部分298在远端设有一个能穿刺组织的刺穿点299。一条狭缝300可以纵向延伸通过近端部分297以及远端部分298以绕固定式滑动件270的近端提供间隙。可以在运动刺穿板296内设置最近端紧固件105,同时第一倒钩107与远端部分298的内表面接触且第二倒钩108与固定式滑动件270接触。可以将固定式滑动件270的最远端部分设置在狭缝300内。
图35显示了使可选择扳机285从第一打开位置运动至第二关闭位置的效果。设置一个箭头以显示运动方向。这种运动能够使运动滑动件260和紧固件105向远端运动至最远端位置。运动刺穿板296可以刺穿网状补片140以及腹股沟板126,以使运动刺穿板296的远端部分298设置在组织内。通过与远端部分298内表面的接触,可以约束倒钩107,108不向外运动。可操纵地使紧固件105的第一腿110与运动滑动件260的最远端台阶121接合以将最远端紧固件105固定在所示的位置处。
在图36中,已释放了可选择外科器械235的可选择扳机285并且运动滑动件260已向近端(参见箭头)返回至最近端位置(图34,37)。当运动滑动件260开始从图35所示的位置向近端运动时,运动滑动件260可以使紧固件105向近端作微量运动。这种向近端的运动可以使紧固件105的每个第二腿111的一端与固定式滑动件270的相应台阶121接触,并能阻止紧固件105进一步向近端的运动。运动刺穿板296返回进入轴92内的向近端的运动可使远端紧固件105的第一和第二倒钩107,108不与固定滑动件270接触。一旦释放,第一和第二倒钩107,108便可以完全配置在所示位置处以使最远端紧固件105保持在组织中。可以将最远端紧固件105的第一和第二腿110,111固定在轴92和固定式滑动件270的最远端锯齿120之间的所示约束位置处。
在图37中,外科医生使外科器械向近端(参见箭头)运动离开腹股沟板126和网状补片140。通过倒钩107,108可以将最远端紧固件保持在腹股沟板内,并且可选择外科器械235的向近端运动可以从轴92拉动最远端紧固件的第一和第二腿110,111。在释放时,紧固件105的第一和第二腿110,111能够急速返回原始倒置形状(图9和10),以将网状补片140固定在腹股沟板上。如图所示,通过紧固件105的第一和第二腿110,111可以使网状补片140牢固地固定在腹股沟板126上。此时,可选择的外科器械235易于将可选择网状补片140固定在另一个位置处。为了实现这一情况,外科医生仅需将轴92的远端重新设置在另一外科手术位置处并驱动扳机285以将可选择紧固件105设置或固定在腹股沟板126内即可。这种过程持续进行,直至可以令人满意地将网状补片140固定至腹股沟板126为止。
锁定机构
本发明的外科器械35(图1)含有多个紧固件105。当外科医生在假体的固定期间反复起动所述器械时,存储在其中的紧固件105的数量不断减少。当将最后的紧固件105设置在组织内时,外科医生无法知道器械排空紧固件105的时间并且可能会试图使空的外科器械35射向组织。在外科器械35内设置一锁定机构,以便在外科器械35排空时锁定扳机85。
如前面所描述的那样,扳机85可以设有一个牢固固定在该处并由该处伸出的锁定臂88。扳机85的驱动可以使锁定臂88从图3的起始位置运动至手柄40内的第一不完全闭合位置处,并且与可转动地安装在轮接收器48的锁定轮100接触,如图24所示。
在图24中,扳机85使锁定臂88逆时针转动以与锁定轮100的齿101啮合。可以使锁定片102设置在锁定臂88的正上方并且锁定片102从锁定轮100向外延伸。锁定爪103固定在右侧手柄4l上且从右侧手柄向外朝观察者延伸以便能够可操作地与锁定轮100啮合。在锁定轮l00下部内设置一个较小的切口以显示锁定爪103向外延伸的端部。
图25为图24中沿剖面25-25所示的远端视图,并且显示了关键部件的必需部分,以便读者能够理解锁定机构的操作。本发明的锁定机构可包括锁定轮100,锁定爪103以及从扳机85伸出的锁定臂88。锁定轮100如图所示,垂直于转动轴线并且可以具有与锁定齿101可操作地啮合的锁定爪103,以防止锁定轮100的顺时针转动。锁定臂由剖面25-25剖开,且横切锁定臂88给出了两个剖面。当锁定臂处于起始位置时,沿锁定臂88的远端剖面显示了第一部分88a,并且沿锁定臂88剖面显示了第二部分88b,以便显示锁定臂88的有效部分。设置一个箭头来说明锁定臂88的第二部分88b的运动方向。
当外科器械35具有紧固件105时,本发明的锁定轮100绕其周面具有相同数量的齿101。如图26所示,当充分驱动扳机85以使一个紧固件105设置在组织内时,可以使锁定臂88与锁定轮100接触,以使锁定轮100逆时针转动或改变一个齿101的位置。在驱动后释放扳机85时,当锁定臂88返回起始位置88a时,锁定爪103可以防止锁定轮100顺时针转动。因此,扳机85的一次完全动作能使锁定轮100转动一个齿101,并且射出所有的紧固件105可以使锁定轮100转动一整圈。
图27-29显示了在可以射出最后一个紧固件105时,锁定片102能够可操作地将锁定臂88(和扳机85)锁定在完全驱动或关闭的位置。在图27中,锁定轮已从图25的第一位置转动了接近一个整圈。其将由锁定片102的新位置表示。锁定臂88的第二部分88b如图所示,向上运动,刚好越过锁定片102并且能够接触最后的锁定齿101。在图28中,锁定臂88的第二部分88b如图所示,处于完全驱动或关闭的位置并且锁定片102能够在锁定臂88的第二部分88b的作用下转动。当释放扳机85时,锁定臂88的第二部分88b能够向下转动以接触锁定片102并且能够使锁定轮100顺时针转动以使齿101与锁定爪103啮合(图29)。与锁定爪103的啮合能够防止锁定轮100顺时针转动并且能够锁定锁定臂88的第二部分88b。因此,在图29中,通过能够防止外科器械35的扳机85打开的锁定爪103,可以将锁定臂88的第二部分88b(以及扳机85)锁定在第一局部关闭的位置处。
图31-33显示了可选择扳机285从第一位置(图31)向第二位置(图32)并返回第一位置(图33)的射击或往复运动时,另一种锁定机构以及其中元件的运动。可选择的锁定机构能够提供许多前述锁定机构的相同特点,如使锁定轮转动,但是可以提供将可选择扳机285锁定在打开位置的另一种锁定形式。可选择的锁定机构具有一个盘状可选择锁定轮205,该锁定轮安装在可选择手柄240上且以逆时针方向转动。可选择锁定轮205可以包括一个盘状面206以及多个从该处伸出的倾斜反向齿207。如果需要,对于存储在可选择的锁定器械235内的每一个紧固件105而言,所述锁定机构可具有一个倾斜的反向齿207。一个反向狭槽207也设置在可选择锁定轮205的盘状面206内。可以在可选择锁定轮205的背面设置一个单向棘爪臂209(图33),以防止可选择锁定轮205的顺时针转动。以特定的角度位置在盘状面206上设置一个第一标志器206a以及一个第二标志器206b,其目的在以下的组装描述中可以得知。
可选择扳机285(图30-33)可旋转地安装在可选择手柄240内,并且可具有一个从该处向近端延伸的可选择反向臂288。可选择反向臂288可具有一个与可选择锁定轮205可选择啮合的远端289。锁定杆290可以从可选择扳机285的背侧延伸(图33)。
锁定件210可包括一个细长件,其在远端具有一个保持器211,一个从锁定件210向下延伸的锁定片212以及一个与远端相邻的锁定孔213(图33)。锁定件210可以是弹簧以便其能够在操作期间偏转。
通过首先将锁定件210的保持器211锁定在右侧可选择手柄半体241中,能够组装锁定机构。锁定件210可以是一根从锁定点向远端延伸的弹簧悬臂梁。接着,可以将可选择锁定轮205设置在一根从右侧可选择手柄半体241伸出的杆(未示出)上。这种布置使一单向棘爪臂209(图33)与从右侧可选择手柄半体241(图30)伸出的多个棘爪齿248中的一个接触。可选择锁定轮205如图所示,由与锁定件210的锁定片212对准的第一标志器206b定位。当可选择外科器械装有十个紧固件105时,可以使用该对准位置,并且在启动锁定之前,可以提供十次发射。在可选择外科器械235装有20个紧固件时,可以利用第二标志器206a对可选择锁定轮205进行定位,以在驱动所述锁定之前,提供二十次发射。
最后,可以将可选择扳机285设置在右侧可选择手柄体241内,可以使扳机弹簧104与可选择的扳机285相连,并且可以固定右侧可选择手柄体241和左侧可选择手柄体242以固定可选择锁定机构以及其它部件。左侧可选择手柄体242的固定可以推动可选择锁定轮205的盘状面206的后侧与锁定件210的锁定片212接触,以使锁定件210的远端从所述接触向下偏转。在图33中,能够最清楚地看到所述偏转为锁定杆290和锁定件210之间的间隙。
可选择锁定件能够按以下方式操作。当使可选择扳机285从图31的第一打开位置向图32的第二闭合位置运动时,可选择反向臂288的近端289能够向上偏转并越过一个静止反向齿208a。反向齿208a如图31所示,位于可选择反向臂288的近端289的正上方并且大致位于该近端的后方。当单向棘爪臂209可锁定地与位于右侧可选择手柄半体241中的多个棘爪齿248(图30)的一个棘爪齿啮合时,可选择的锁定轮285在该动作期间可保持静止。该锁定啮合能够防止可选择锁定轮285的顺时针转动。另外,单向棘爪臂209能够在可选择锁定轮205的逆时针转动期间,提供滑动动作。
一旦反向臂288的近端289越过可选择锁定轮205上的反向齿208a,近端289便能够以弧形自由运动至图32的位置处。接着,可以释放可选择扳机285以从图32的第二关闭位置返回至图31&32的第一打开位置。当可选择扳机285接近第一打开位置时,反向臂288的近端289能够运动返回至与前面所述的反向齿208a接触并向下推动齿208a到达图33所示的位置处。因此,可选择扳机285的每一次射击或往复运动均能从可选择外科器械235发射一个紧固件105并且使可选择锁定轮205改变一个齿的位置。可选择扳机285的持续发射或往复运动能够从可选择外科器械排空紧固件105并且以一次发射射出一个齿的方式使可选择锁定轮205逆时针运动。该过程将持续进行直至从可选择外科器械射出最后一个紧固件105并且计数器狭槽207从图31-32所示的6:00点钟的位置逆时针运动至12:00点钟的位置(未示出)。当计数器狭槽207处于12:00点钟的位置时,可以释放锁定件210的锁定片212以弹入或运动进入计数器狭槽207内。该动作能够使锁定件210的锁定孔213运动离开右侧手柄半体241并能够利用锁定孔213锁定锁定杆290。当发射出最后的紧固件105时,该动作能够将可选择扳机285锁定在第一打开位置处。
应认识到:可以利用等同的结构来代替此处所说明和描述的结构,并且本发明的所述实施例不是唯一可用于实现所要求保护的发明的结构。作为可用于实现本发明的等同结构的例子,可采用这样一种输送机构,该机构能够使一对相对设置的元件向远端运动,这对元件能够使一个紧固件向远端运动,所述远端运动能够将紧固件的远端设置在组织内,能够通过使一个元件向近端运动而使紧固件的远端部分设置在组织内,并且能够通过使剩余元件向近端运动而使紧固件的远端完全设置在组织内。作为可用于实施本发明的等同结构的另一个例子,可以提供一种输送机构,该机构能够以相反的方向连续使一对相对设置的部件往复运动以向远端推动紧固件,并且能够通过第一次互换使紧固件的远端部分设置在组织内,通过第二次互换使紧固件完全设置在组织内。另外,应理解上述每一种结构均具有一种功能并且该结构可被认为是实现这种功能的方式。
虽然在本申请中已给出了本发明的最佳实施例,但是对于本领域技术人员来说显而易见的是,这些实施例仅是以例子给出的。在不脱离本发明的情况下,本领域技术人员可作出各种改进,变化和替换。因此,本发明应仅由所附权利要求的思想和范围限定。

Claims (17)

1.一种用于射出多个独立的外科紧固件的射出装置,所述射出装置包括:
a.一个具有远端和近端的驱动机构,所述驱动机构包括一个运动部件和一个固定的相对部件,所述运动部件可相对于所述射出装置向近端和远端运动,所述运动部件具有一个用于刺穿组织的锋利的末端;
b.至少一个设置在所述第一和所述第二部件之间的外科紧固件,所述至少一个外科紧固件中的每一紧固件均具有一个近端和一个远端;
c.一个具有至少两个顺序位置的促动器,第一位置用于使所述运动部件向远端运动并刺穿组织,而第二位置用于使所述运动部件向近端运动,从而调度所述紧固件的所述远端。
2.根据权利要求1所述的射出装置,其中:运动和固定部件具有内表面,这些内表面具有多个在其上分离的凸起,所述凸起与所述紧固件接合。
3.根据权利要求1所述的射出装置,其中:所述紧固件包括一个主体,该主体具有一个远端,一个近端以及位于运端和近端之间的一纵向轴线,所述紧固件包括至少一个沿轴向离开所述远端延伸的倒钩,以及一个沿轴向离开所述第二端部延伸的倒钩。
4.根据权利要求3所述的射出装置,其中:所述倒钩接合所述运动部件和固定件的内表面。
5.根据权利要求1所述的射出装置,其中:紧固件由不锈钢制成。
6.根据权利要求1所述的射出装置,其中:所述紧固件由一种超弹性合金制成。
7.根据权利要求6所述的射出装置,其中:超弹性合金为镍钛合金。
8.根据权利要求1所述的射出装置,其具有多个设置在所述运动部件和固定部件之间的紧固件,且所述紧固件不会彼此接合并且彼此分离。
9.一种用于射出多个独立的外科紧固件的射出装置,所述射出装置包括:
a.一个具有远端和近端的驱动机构,所述驱动机构包括一个运动部件和一个固定的相对部件,所述运动部件可相对于所述射出装置向近端和远端运动;
b.至少一个设置在所述第一和所述第二部件之间的外科紧固件,所述至少一个外科紧固件中的每一紧固件均具有一个近端和一个远端;
c.一个具有至少两个顺序位置的促动器,第一位置用于使所述运动部件向远端运动并刺穿组织,而第二位置用于使所述运动部件向近端运动,从而调度所述紧固件的所述远端;
d.一种机构,该机构在所述促动器已完全运动至其第一位置之前,在所述促动器最初向所述第一位置运动之后,防止其向所述第二位置运动,而在所述促动器已完全运动至其第二位置之前,在所述促动器最初向所述第二位置运动之后,防止其向所述第一位置运动。
10.根据权利要求9所述的射出装置,其中,第一和第二部件具有内表面,这些内表面具有多个在其上分离的凸起,所述凸起与所述紧固件接合。
11.根据权利要求9所述的射出装置,其中,所述紧固件包括包括一个主体,该主体具有一个远端,一个近端以及位于运端和近端之间的一纵向轴线,所述紧固件包括至少一个沿轴向离开所述远端延伸的倒钩,以及一个沿轴向离开所述第二端部延伸的倒钩。
12.根据权利要求11所述的射出装置,其中:所述倒钩接合所述第一部件和第二部件的内表面。
13.根据权利要求9所述的射出装置,其中:紧固件由不锈钢制成。
14.根据权利要求9所述的射出装置,其中:所述紧固件由一种超弹性合金制成。
15.根据权利要求14所述的射出装置,其中:超弹性合金为镍钛合金。
16.根据权利要求9所述的射出装置,其具有多个设置在所述第一部件和第二部件之间的紧固件,且所述紧固件不会彼此接合并且彼此分离。
17.根据权利要求9所述的射出装置,其中:所述运动部件具有一个用于刺穿组织的锋利末端。
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US7485124B2 (en) 2009-02-03
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US7905893B2 (en) 2011-03-15
ES2338710T3 (es) 2010-05-11

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