CN102245111B - 具有能够收回的部件的手术针体和锚杆系统 - Google Patents
具有能够收回的部件的手术针体和锚杆系统 Download PDFInfo
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Abstract
提供多种手术导引器针体和锚杆系统。该系统可以包括导引器针体和组织支撑植入物或悬带装置。植入物装置可以包括一个或多个锚固装置。导引器针体装置可以包括手柄组件和针体组件。针体组件可以包括大致空心的针体和可在针体中来回移动的线。该线可以包括远端尖端,所述远端尖端适于在部署锚杆和/或植入物时从所接合的锚固装置选择地收回或撤回。
Description
相关申请
本申请要求享有2008年10月27日提交的美国临时申请No.61/108,686、2009年4月28日提交的美国临时申请No.61/173,396以及2009年6月12日提交的美国临时申请No.61/186,616的优先权和权益,每个所述申请的全部内容通过参考包含于此。
技术领域
本发明总体上涉及手术方法和设备,并且更具体地,本发明涉及一种手术针体,所述手术针体适于选择地接合一个或多个植入锚杆,所述植入锚杆例如是用于锚固到软组织的那些植入锚杆。
背景技术
男性和女性的骨盆健康是重要性日益增加的医学领域,这至少部分是由于人口的老龄化。常见骨盆疾病的示例包括失禁(大便失禁和尿失禁)、骨盆组织脱垂(例如,女性阴道脱垂)和骨盆底的病况。
除了其它类型之外,尿失禁可以进一步分类为包括不同的类型,例如压力性尿失禁(SUI)、急迫性尿失禁、混合型尿失禁。其它骨盆底病症包括膀胱膨出、直肠膨出、阴道后疝、和脱垂,所述脱垂例如是肛门脱垂、子宫脱垂和阴道穹窿脱垂。膀胱膨出是通常进入阴道和阴道口中的膀胱突出。诸如这些病症的骨盆病症可能是由于正常的骨盆支撑系统的弱化或损伤所导致的。
在其最严重的形式中,阴道穹窿脱垂可能导致阴道顶端膨胀到阴道外部。阴道后疝是一种阴道突出,其中含有小肠的一部分的腹膜囊延伸到直肠阴道空间中。阴道穹窿脱垂和阴道后疝对于外科医生来说表示骨盆病症的挑战形式。这些手术经常包括冗长的手术时间。
尿失禁的特征可以体现在随着膀胱由尿液填充而维持尿道括约肌关闭的能力的丧失或降低。当患者身体上受到压力时出现男性或女性的压力性尿失禁(SUI)。
骨盆健康的特定区域是骨盆底的损伤,例如提肌(“肛提肌”)的损伤或尾骨肌的损伤(统称为骨盆底)。骨盆底由提肌和尾骨肌构成,并且提肌由包括耻骨直肠肌、耻尾肌和髂尾肌的组成部分构成。因为多种原因,提肌会受到弱化或损伤,例如提肌裂孔、气胀或提肌撕脱的伤害,这些伤害中的任一种都可能导致诸如脱垂、大便失禁或其它骨盆病况的症状。
提肌缺陷(弱化或损伤)可以影响提肌的任何部分,并且可以在包括耻尾肌和耻骨直肠肌的肛提肌的耻骨部分中尤为普遍。这些缺陷例如在具有阴道脱垂的女性中是较普遍的。缺陷也可以存在于髂尾肌处。另外其它的缺陷是阴道旁缺陷的形式,例如肛提肌从骨盆侧壁的inferiomedial(下内侧)方面的撕脱;撕脱可以涉及到组织从耻骨分开,并且可以先于骨盆病况之前出现。另一种提肌缺陷是提肌气胀,所述提肌气胀涉及提肌胀大。
不同的提肌缺陷是提肌裂孔的缺陷,其可以降低骨盆底的稳定性并且可能导致性功能障碍、排便功能障碍、直肠脱垂和大便失禁。提肌裂孔也认为在脱垂的进程中发挥重要的作用。
期望得到一种微创但仍高效的针体和锚固系统,所述针体和锚固系统可以用于治疗失禁、骨盆器官脱垂和其它病况。
发明内容
在一个实施例中,手术导引器针体和锚杆套件或系统包括:可植入的支撑设备,例如悬带、网状物或带;手柄组件和具有可收回的线的针体组件;以及一个或多个锚固装置,所述一个或多个锚固装置通常附装在支撑设备的一个或多个端部处。每个锚杆装置都适于附装到患者的骨盆内的组织,使得附装到患者组织允许选择性地放置支撑设备以支撑患者的膀胱、尿道或其它器官或组织。手柄和针体组件适于操作地和选择地接合和引导该系统的锚杆和支撑设备。
针体和锚固组件可以构造成在接合锚杆装置或植入物方面以及在部署时从锚杆收回针体或针体的一部分方面提供增大的精确度、可靠性和实用性。本发明的针体系统的多种实施例可以包括手柄,所述手柄与插管状针体和内线或类似结构操作地联接,以便使线的远端尖端可选择地与植入物或锚杆接合或从植入物或锚杆收回。内线和相应的远端尖端能够借助诸如滑动器致动器的至少一个致动器在针体内部收回。
手柄组件的其它实施例可以包括闭锁组件,以在部署期间限制线远端尖端的向后行进,其中尖端能够在使用至少一个致动器时收回。
手柄组件的另外其它实施例可以包括作为至少一个致动器的卡锁或触发器(clicker or toggle)机构,以选择地触发线远端尖端的收回和延伸。
可以包括多种锚杆系统以提供安全性,以便使锚杆将不容易在插入期间从针体分开或脱离,而同时仍然允许在将锚杆部署在例如患者的骨盆区域内的软组织内期间准确地放置锚杆和使锚杆从针体分开。例如,针体或针体的一部分从锚杆的收回促进稳定且准确的定位,这是因为没有迫使锚杆从针体装置分开或者将锚杆从针体装置推离(致使锚杆位置运动或移动)。相反,锚杆牢固地落座成与针体邻接接触(例如,倒钩防护装置),以便使针体或线的收回没有总体上改变锚杆的角度、定位或位置。
附图说明
图1是根据本发明的实施例的手术导引器针体和锚杆系统的透视图;
图2是根据本发明的实施例的手术导引器针体和锚杆系统的俯视图;
图3是根据本发明的实施例的手术导引器针体和锚杆系统的侧视图;
图3a是沿着图3的线3a-3a得到的手术导引器针体和锚杆系统的示意性剖视图;
图4是根据本发明的实施例的、具有闭锁组件的手术导引器针体和锚杆系统的示意图;
图5是根据本发明的实施例的、具有闭锁组件的手术导引器针体和锚杆系统的示意图;
图5a是根据本发明的实施例的、具有闭锁组件的手术导引器针体和锚杆系统的示意图;
图5b是根据本发明的实施例的、具有闭锁组件的手术导引器针体和锚杆系统的示意图;
图6是根据本发明的实施例的针体组件的示意性俯视图;
图7是根据本发明的实施例的针体组件的示意性侧视图;
图8是根据本发明的实施例的致动器线的示意性俯视图;
图9是根据本发明的实施例的线远端尖端部分的示意性侧视图;
图10是根据本发明的实施例的、与远端尖端部分联接的致动器线的示意性侧剖视图;
图11是根据本发明的实施例的手柄致动器的示意性俯视图;
图12是根据本发明的实施例的针体组件和手柄致动器的示意性俯视图;
图13是根据本发明的实施例的对准部分和针体的示意性正剖视图;
图14是根据本发明的实施例的远端针体部分和线尖端的示意图;
图15是根据本发明的实施例的远端针体部分、线尖端和锚杆装置的示意性俯视图;
图16是根据本发明的实施例的远端针体部分、线尖端和锚杆装置的示意性俯视图;
图17是根据本发明的实施例的具有端部锚杆装置的悬带植入物的示意性俯视图;
图18是根据本发明的实施例的、与端部锚杆装置联接的悬带植入物的示意图;
图19是根据本发明的实施例的、具有触发器机构的手术导引器针体和锚杆系统的透视图;
图20是根据本发明的实施例的、具有触发器机构的手术导引器针体和锚杆系统的示意图;
图21是根据本发明的实施例的、具有触发器机构的手术导引器针体和锚杆系统的示意图;
图22是根据本发明的实施例的楔入配合针体和锚杆系统的示意性剖视图;
图23至24是根据本发明的实施例的咬合配合针体和锚杆系统的示意性剖视图;
图25至26是根据本发明的实施例的裂开的尖端和楔入针体和锚杆系统的示意图;
图27至28是根据本发明的实施例的管和楔入锁定针体和锚杆系统的示意图;
图29a至31b是根据本发明的实施例的锁定倒钩针体和锚杆系统的示意图;
图32a至32c是根据本发明的实施例的咬合配合针体和锚杆系统的示意图;
图33至34是根据本发明的实施例的挤压锁定针体和锚杆系统的示意图;
图35是根据本发明的实施例的受限的压配合针体和锚杆系统的示意图;
图37至38是根据本发明的实施例的单侧区域性的压配合针体和锚杆系统的示意图。
具体实施方式
总体上参照图1至21,其中示出了手术导引器针体和锚杆系统10的多种实施例。通常,系统10可以包括针体装置和组织支撑植入物或悬带装置。植入装置可以包括一个或多个锚固装置。锚固装置可以称为自固定锚杆或尖端。导引器针体装置可以包括手柄组件18和针体组件20。系统10可以用于将植入物锚固在女性体内以支撑组织,从而治疗失禁、脱垂或其它骨盆健康病况。本发明可以用于校正中央缺陷、中线缺陷、同时校正中央缺陷和中线缺陷二者、以及校正其它类似的病况。另外,系统10的多种部件可以由诸如聚合物、金属或其它类似材料的材料构造,对于本领域的技术人员来说,这些材料适合于与手术针体、手柄以及锚杆装置和系统一起相容使用。
可以预见到的是,本文中详细说明的多种系统10、特征和方法用于与许多已知的植入物和修复系统(例如,用于男性和女性)、特征和方法一起使用,这些植入物和修复系统、特征和方法包括在美国专利No.7,351,197和6,691,711、国际专利公开No.WO 2008/057261和WO 2007/097994、美国专利公开No.2002/151762和2002/147382、以及2008年7月25日提交的国际专利申请No.PCT/US2008/009066中所公开的那些。因此,以上列出的公开整体通过参考包含于此。
总体上参照图1至18,其中示出了手柄组件18和可收回的针体组件20。手柄组件18可以设置成具有蛤壳构造,并且可以由聚合物材料、金属以及对于本领域的技术人员来说已知的其它材料构造。手柄18可以构造成包括第一部分18a和第二部分18b,所述第一部分18a和第二部分18b适于彼此咬合或以其它方式相互紧固或联接。可以采用多种已知的紧固件、配件、轴套和柱体、以及类似的附装构造和技术来将手柄18的部分18a、18b连结或附装在一起。手柄组件18还可以包括一个或多个致动器34,例如两个致动器滑动器34a、34b,所述两个致动器滑动器34a、34b可以滑动、被加压或以其它方式接合,以使针体组件20的至少一部分伸出或收回。布置在手柄组件18的空腔或其它部分内的是诸如弹簧的偏压构件36。如本文中详细地说明的那样,在一个实施例中,偏压构件36将一个或多个致动器34偏压在伸出位置中。
每个外壳部分18a、18b都可以包括颈部部分22以及通道或凹陷部24。当外壳部分18a、18b联接起来时,凹陷部24限定开口26,所述开口26适于为致动器34a、34b提供空间,以供致动器34a、34b沿着所述空间或在所述空间内来回移动(traverse)或滑动,同时致动器34a、34b的至少一部分从开口26伸出来。类似地,外壳部分18a、18b的联接将多个颈部部分22连结起来,以限定用于环箍(shrouding)针体组件20的一部分的开口。
如图6至7中所示,针体组件20可以包括细长的插管状针体40,所述细长的插管状针体40具有近端端部42和接合尖端或远端端部44,其中内腔43延伸通过所述插管状针体40。近端端部42适于与手柄组件18相互配合或操作地连接到手柄组件18。因而,近端端部42可以包括对准部分45,所述对准部分45例如是对准块体,所述对准块体适于将近端端部42搁置或以其它方式对准和固定在手柄组件18内或所述手柄组件18的部件内,从而总体上在使用期间将针体40保持在固定的位置中。
在一个实施例中,针体40的至少一部分大致被弯曲或者是弓形的(例如图1、3和7),以帮助骨盆导引和可操作性。针体40可以构造成具有介于约4英寸和6英寸之间的总长度,其中大致直的部分介于3英寸和4英寸之间,而曲线部分将剩余的长度延伸到远端端部44。针体40的这种设计可以具有约0.07英寸至0.10英寸的外径,内腔43可以具有多种内径(例如,大约0.030英寸)。然而,在其它的实施例中,针体40可以沿着其整个长度是大致直的,或者可以采用其它已知的形状和尺寸构造的变型方案。针体40或针体40的一部分可以由相容的聚合物或包括不锈钢在内的金属构造。在外壳组件18内,针体40的近端端部42可以延伸通过并越过对准部分45,并且可以被固定或构造成限制针体40的转动运动。
另外,如图8至10中所示,针体组件20可以包括致动器线50,所述致动器线50能够至少沿着针体内腔43的内径的一部分来回移动。线50或线50的一部分可以由相容的聚合物或包括不锈钢在内的金属构造。线50包括线近端部分52和线远端部分或尖端54。线近端部分52适于操作地与手柄组件18内的部件或结构相互作用或连接,所述手柄组件18内的部件或结构例如是一个或多个致动器34的一部分。在一个实施例中,线远端部分或尖端54可以是与线50的端部联接的单独构件。例如,远端尖端54的直径可以显著地大于线50的直径,从而包括限定在所述远端尖端54中的联接通道或凹陷部54a,所述联接通道或凹陷部54a用于接收和固定相对较细的线50(图9至10)。线50能够沿着内腔43的一段距离收回和伸出,以便使线远端部分54能够从针体40的远端端部44和内腔43延伸或延伸出来。在其它的实施例中,线50或线50的至少一部分可以沿着针体的外侧布置或横过针体的外侧,例如通过针体外部的套管、沿着针体的外部长度、通过或沿着总体上与针体分开或截然不同的内腔或结构等等。
如本文中所提供的那样,对准部分45可以适于与针体40的近端端部42的一部分匹配或联接,以用于整合在手柄组件18内,如图12中所示。例如,在一个实施例中,对准部分45可以是大致H状的,其中,在所述对准部分45中限定内腔47以接收针体40的近端端部42。这样,可以在对准部分45内设置接收通道49,以可滑动地接收致动器34的多个部分。
在图11至13中所绘制的实施例中,一个或多个致动器34可以构造成包括两个致动器34a、34b、本体部分35、近端基部37和缺口39。本体部分35可以从相应的致动器34a、34b延伸到外壳18中,以在它们之间限定缺口39。近端基部37可以适于接收线50的近端部分52,例如通过将线50的近端部分52卷曲(crimping)或以其它方式固定到近端基部37的一部分(图12)。在一个实施例中,线50的近端部分52可以卷曲在近端基部37的固定部分37a处。另外,近端基部37中可以包括孔或凹陷部,以接收偏压构件36的至少端部区域,同时偏压构件36的另一个端部区域抵靠在手柄半体18a、18b中的至少一个内的一个或多个结构上。
从致动器34a、34b延伸的本体部分35可以布置在针体40的对准部分45的作为导向部件的相对应的接收通道49内,或者从致动器34a、34b延伸的本体部分35可以延伸到所述相对应的接收通道49内,以便使相应的本体部分35可以在接收通道49内滑动,同时对准部分45基本上保持固定。在这种构造中,本体部分35可以在通过致动器34a、34b的最终用户激活或接合时在通道49内或者沿着通道49滑动,同时仍然保持部件在手柄组件18内的放置和固定。因此,针体40被大致固定,并且联接到致动器的近端基部37(例如,在部分37a处)的线50适于相对应地与致动器34a、34b一起行进。在不脱离本发明的精神和范围的情况下,也可以采用手柄组件18(包括它的滑动、导向和联接部件)的其它构造和设计。
总体上参照图4至5以及14至16,当致动器34a、34b处于例如大致远离手柄组件18的伸出位置时,线远端部分54也处于例如大致远离针体40的远端端部44的伸出位置或可接合位置(例如,从内腔43伸出)。类似地,当致动器34a、34b朝向手柄组件18滑动或以其它方式运动到脱离位置时,线50和相对应的线远端部分54朝向针体40的远端端部44收回或收回到针体40的远端端部44中(例如,到内腔43中)。
如图15至18中所示,线远端部分或尖端54适用于且构造成与锚杆16接合。锚杆16可以是设置在悬带植入物17(例如,网状物或其它已知的组织支撑结构)的端部处的固定的、或自固定的组织锚杆。植入物17的锚杆16适于附装在患者的骨盆区域的目标组织内或者通过所述目标组织附装,包括在本文中和在所包含的参考文献中所公开的那些。
在伸出的位置中,线远端部分54可以滑动成或咬合成与锚杆16接合。锚杆16和/或线远端部分54可以包括用于帮助接合和保持锚杆16直到线远端部分54从与锚杆16的接合收回为止的特征。在一个实施例中,线远端部分54的形状和尺寸设计成(例如,渐缩的、球根状的,等等)延伸到锚杆16内的内部通道或孔60中,以迫使它或以其它方式使它与锚杆16能够匹配地接合。线远端部分54的至少一部分能够从所接合的锚杆16伸出一定距离(图15)。在致动器34a、34b以及相对应的线远端部分54收回时,锚杆16总体上脱离与针体40及它的部件的接合。在本文中更加详细地公开了构造成帮助锚杆16与线远端部分54或针体远端端部44选择地接合的其它实施例。
如图15至16中所示,针体组件40还可以包括倒钩防护装置64,所述倒钩防护装置64设置在远端端部44附近。倒钩防护装置64可以包括联接部分67和一个或多个延伸构件65。倒钩防护装置64的形状设计成并且构造成与锚杆16的延伸的尖齿61接合。例如,倒钩防护装置64可以包括一个或多个延伸构件65。延伸构件65可以是直线的、曲线的、向外展开的和/或成角度的,或者可以采用多种其它相容构造。倒钩防护装置64可以防止尖齿61与组织接合,直到线远端部分54与锚杆16脱离为止,并且当在激活一个或多个致动器34a、34b的情况下线远端部分54被收回或向后拉以脱离锚杆16时,倒钩防护装置64可以提供用于锚杆16的邻接面。
在一个实施例中,如图4至5b中所示,手柄组件18包括闭锁组件70。闭锁组件70通常在手柄80中提供这样的部件,即,所述部件适于在部署期间或者在致动器34a、34b接合以收回尖端54之前,阻止远端尖端54收回或向后行进。这种部件能够有利于在锚杆16停靠(docking)在尖端54上期间阻止尖端54收回。另外,这种部件在这些手术中可以是有利的,在所述手术中,尖端54可能会与骨头、装置或植入结构、或其它的实心或不期望的表面进行强迫接触,由此防止尖端54在部署锚杆16完成之前收回。
闭锁组件70可以包括本体部分71和邻接部件75。本体部分71包括一个或多个翼状构件72。在一个实施例中,翼状构件72向外张开一定角度,其中在翼状构件72的端部处限定翼状尖端74a、74b。翼状构件72可以由例如聚合物或金属的材料构造,翼状构件72具有显著的柔性水平,以便使翼状构件72可以朝向本体部分71内变形、弯曲、枢转或以其它方式运动至少一小段距离。邻接部件75可以通过设有对准部分45的一个或多个壁部分或设置在对准部分45内的凹陷部限定,例如近端基部37(图5a)。邻接部件75的多个壁可以在定位的翼状构件72附近成角度。这样,本体部分71落座在邻接部件75内或与邻接部件75相邻。另外,翼状尖端74a、74b从对准部分45的一部分或表面延伸出来,以接合手柄部分18a、18b中的至少一个中的相对应的结构(图5b)。例如,翼状尖端74a、74b的尺寸和形状可以设计成接合手柄部分18a、18b中的凹口、槽或其它结构。
在尖端54从针体40延伸的初始的落座位置中,本体部分71落座在邻接部件75内,翼状构件72松开或完全延伸,并且翼状尖端74a、74b与手柄18的相应部分接合。在这个初始的位置中,在致动器34a、34b没有接合的情况下,将抵抗针体尖端54上的压力,以便大致防止向后行进或收回。即,翼状尖端74a、74b根据翼状尖端74a、74b在手柄18的匹配结构内的落座位置而抵抗向后运动,并且因此操作地联接的远端尖端54不会收回。然而,在致动器34a、34b朝向手柄18接合时,对准部分45将开始运动,这继而使所包括的围绕本体部分71的邻接部件75运动。结果,邻接部件75的成角度的壁将开始接触翼状构件72。翼状构件72上的这个压力将致使翼状构件72至少向内轻微地变形或弯曲,使得翼状尖端74a、74b同样向内运动,直到它们从壳体18中的结构(它们初始地落座或固定在这些结构处)释放的点为止。在翼状尖端74a、74b从固定的位置释放的情况下,致动器34a、34b连同这些致动器的相对应的本体部分35和基部部分37一起自由运动,以便收回操作地联接的远端尖端54。
系统10的其它实施例,例如图3a中所绘制的实施例,可以构造成没有本文中说明的闭锁组件70。
在一般用法中,手柄组件40的致动器34a、34b最初可以处于延伸的或可接合的位置中,使得线远端部分54也处于延伸的/可接合的位置(图3至4和14)。这样,诸如软组织锚杆的锚杆16可以插入、配合、咬合、或以其它方式联接到远端端部54(图15)。如所阐述的那样,网状物、悬带或支撑装置或结构17可以与组织锚杆16连接(图17至18)。针体40、远端端部54和组织锚杆16插入到患者的骨盆区域中到达目标组织位置,在所述目标组织位置处锚杆16可以插入到目标组织中或插入通过目标组织。用户可以继而激活或接合致动器34a、34b,以使致动器朝向手柄组件18滑动(图5)。这继而压缩偏压构件36并且致使线50收回,使得远端部分54相对应地撤回(图5和16)。在某些实施例中,致动器34a、34b的激活进一步使闭锁组件70脱离,以允许远端部分54收回(图5a至5b)。在收回过程中的一点处,远端部分54通过锚杆孔60撤回,由此从锚杆16脱离或拉离锚杆16,将锚杆16以及网状物、悬带或其它支撑装置17或所锚固的结构留在目标组织内。手柄18中的听得见的咔嚓声或混响可以给用户提供锚杆16和线远端部分54脱离的指示。可以重复这个处理,以用于多个锚杆16插入和目标组织锚固手术。
系统10的其它实施例可以包括卡锁或触发器机构80,所述卡锁或触发器机构80适于选择地伸出和收回针体40内的线远端部分54。例如,触发器机构80可以操作地联接到手柄组件18和针体组件16。触发器机构80可以包括外壳82和致动器84,其中触发器机构80设有手柄组件18,并且至少部分地容纳在手柄组件18内。机构80可以根据本文中所说明的其它实施例构造,其中机构80用于替换致动器34a、34b,使得致动器84的激活控制线远端部分54的延伸和收回。在这种实施例中,可以全部或部分地采用先前所述的实施例的针体20、线50和手柄18部件。
本发明的多种实施例所采用的触发器机构80可以效仿或模仿多种书写的笔产品中所使用的已知的转动锁定机构。例如,致动器84的加压导致操作联接的构件(例如,针体90)在延伸的位置和收回的位置之间触发。
如图19至21中所示的采用触发器机构的其它实施例可以效仿本文中先前说明的实施例的那些。然而,这些实施例可以包括大致实心的针体90(例如,不是空心的)、手柄组件92和管状构件94。手柄组件92可以设置成蛤壳构造,以限定两个手柄部分92a、92b。手柄组件92还可以包括弹簧36,所述弹簧36与触发器机构80操作地联接。针体90从远端端部或尖端91延伸到近端端部93,所述近端端部93操作地联接到触发器机构80。针体90可以包括垫圈49a,所述垫圈49a附装到针体90并且适于邻接弹簧49的近端端部,同时针体90延伸通过弹簧49。
管状构件94构造成覆盖或包围针体90的从手柄组件92延伸出来的一部分。管状构件94的近端端部94a布置在手柄组件92内,以将近端端部94a固定在大致固定的位置中,同时针体90可在管状构件94内滑动。管状构件94可以在其远端端部94b处包括倒钩防护装置96,其中针体90的远端端部91适于从远端端部94b延伸出来和收回到远端端部94b中。
在某些触发器机构实施例的一般用法中,针体尖端91初始处于延伸的/可接合的位置中(图19至20)。这样,诸如软组织锚杆的锚杆16可以插入、配合、咬合或以其它方式联接到尖端91(图19)。如所阐述的那样,网状物、悬带或支撑装置或结构17可以与组织锚杆16连接(图17至18)。针体90、尖端91和组织锚杆16插入到患者的骨盆区域中到达目标组织位置,在所述目标组织位置处锚杆16可以插入到目标组织中或插入通过目标组织。用户可以继而激活或接合致动器84(例如,卡锁或触发器按钮),这继而致使针体90收回以使偏压构件36减压。该减压进一步使针体尖端91从其最初的延伸位置撤回(图21,示出为没有倒钩防护装置)。在收回过程中的一点处,尖端91通过锚杆孔60撤回,由此使尖端91脱离锚杆16或拉离锚杆16,将锚杆16以及网状物、悬带或其它支撑装置17或所锚固的结构留在目标组织内。手柄92中的听得见的咔嚓声或反响可以给用户提供锚杆16和针体尖端91脱离的指示。可以重复这个处理,以用于多个锚杆16的插入和目标组织锚固手术。
本文中所公开的、以其它方式已知的和/或先前通过参考结合的多种手术导引器针体和锚杆系统可以包括多种机构、部件或装置,所述多种机构、部件或装置构造成在保持和释放植入锚杆方面提供更高的可靠性和实用性。本发明的锚杆系统的多种实施例可以包括硬停楔入装置(hard stop wedge devices)、切口的咬合配合装置、裂开的针体尖端楔入装置、管和楔入锁定装置、锁定倒钩装置、咬合配合装置、挤压锁定装置、受限的压配合装置、单侧的区域性的压配合装置以及类似的装置或构造。
总体上如图22至39中所示的示例性的锚杆系统100可以包括锚杆101,所述锚杆101具有内部通道或孔102,所述内部通道或孔102从近端端部104朝向远端端部106沿着锚杆101的总纵向长度的至少一部分延伸。内部通道102能够接收插入工具的长形针体110的远端端部(例如,针体或线尖端),以允许诸如自固定尖端的锚杆在植入手术期间被推动到骨盆组织内的位置中。这种锚杆系统100提供安全性,使得锚杆101不容易在插入期间从针体分离或脱离,同时仍然允许用于在将锚杆部署在患者的骨盆区域内(例如软组织内)期间准确地放置锚杆和从针体分离锚杆。
图22绘制出了具有硬停和楔入部件120的锚杆系统100的实施例,所述硬停和楔入部件120适于将针体110和锚杆101相互锁定以选择地接合和脱离。锚杆101可以包括邻接表面103。楔块120在针体110内的相对应的缩进的或有凹口的行进路径121内滑动,以产生硬停干涉,来将锚杆101保持在适当的位置中并且在激活时提供选择性释放。楔块120可以操作地联接到针体、联接到布置在针体内的线、或联接到锚杆,用于相对应的滑动,以帮助针体110与锚杆101的接合/脱离。在多种实施例中,针体器械可以由不锈钢或其它相容的材料构造,而锚杆可以由多种材料构造,例如,聚丙烯、生物相容的金属、陶瓷、一般的聚合物和可再吸收的聚合物。
图23至24绘制出了具有切口的咬合配合部件124的锚固系统100的实施例,所述切口的咬合配合部件124适于将针体110和锚杆101相互锁定,以用于选择地接合和脱离。部件124可以沿着锚杆101或孔102的一部分包括突起124a,所述突起124a能够与针体40中的相对应的缩进部或凹口125咬合接合。图24绘制出了部件124的实施例,其中突起124a设置成与锚杆101的远端尖端相距一定距离,以产生更大的弯曲,并且由此帮助咬合接合。
图25至26绘制出了具有裂开的针体尖端110和楔入部件130的锚固系统100的实施例,所述裂开的针体尖端110和楔入部件130适于将针体110和锚杆101相互锁定,以用于选择性接合和脱离。这个实施例可以包括:针体110,所述针体110沿着自身具有裂口;和可滑动的楔块132,所述可滑动的楔块132设置成使得将楔块向后拉动使针体在针体的远端端部附近展开。这继而使针体110的端部展开,以将锚杆101保持在适当的位置中。反向执行这些步骤可以类似地释放对锚杆101的保持,从而允许锚杆从针体的选择释放。楔块132可以选择地联接到系统中的拉动装置,所述拉动装置包括线、缝线或其它的联接构件。
图27至28绘制出了具有管和楔入部件138的锚固系统100的实施例,所述管和楔入部件138适于将针体110和锚杆101相互锁定,以用于选择性的接合和脱离。楔块139作为针体系统110的一部分附装或以其它方式沿着管状构件140的一部分设置。这样,针体110与管状构件140的相对运动驱动楔块139在针体110的槽141中运动。楔块139的这个运动使锚杆101与针体110选择性地接合。附装构件143可以联接管状构件140和楔块139,以帮助楔块139运动。另外,附装构件143可以停驻在槽144中和/或在槽144中行进。
图29a至31b绘制出了具有锁定倒钩和防护部件148的锚固系统100的实施例,所述锁定倒钩和防护部件148适于将针体110和锚杆101相互锁定,以用于选择性的接合和脱离。倒钩部件148可以沿着针体110的远端部分包括倒钩或短小突出部150或其它突起,其中倒钩150适于选择地接合锚杆101中的相对应的缩进部件151,以用于使锚杆101与针体110选择性地接合。也公开了倒钩和防护部件148的其它变型方案。例如,图31a至31b的实施例还可以包括趋向于保持在打开位置的相对柔性的防护部件148(图31a)。可以包括管构件152,使得当管152向前滑动时,倒钩防护部件运动到关闭位置,以使倒钩150与锚杆缩进部151或锚杆的其它部分接合(图31b)。
图32a至32c绘制出了具有咬合配合部件156的锚固系统100的实施例,所述咬合配合部件156适于将针体110和锚杆101相互锁定,以用于选择性地接合和脱离。锚杆101可以包括突起158、短小突出部、或类似部件,所述突起158、短小突出部、或类似部件适于与针体110中的相对应的缩进或槽部件160接合。替换地,突起158可以沿着针体110的一部分设置,同时锚杆101包括可接合的缩进或槽部件160。也公开了咬合配合部件156的其它变型方案,其中锚杆101中的突起158通过模制处理设置或形成(例如,通过塑孔栓形成和/或通过模制部分或半体形成)。
图33至34绘制出了具有挤压锁定部件164的锚固系统100的实施例,所述挤压锁定部件164适于将针体110和锚杆101相互锁定,以用于选择性地接合和脱离。挤压锁定部件164可以包括线166或其它机构,使得针体110的尖端在所施加的张力下张开。这种张开提供锚杆101上的保持(图34)。当张力释放时,针体尖端返回到其放松的状态,从而允许锚杆101从针体110滑落(图33)。
图35绘制出了具有受限的压配合部件170的锚固系统100的实施例,所述受限的压配合部件170适于将针体110和锚杆101相互锁定,以用于选择性地接合和脱离。受限的压配合部件170可以限于这样的结构,例如沿着针体110的有限的或预定的长度的台阶部件172。因而,远端针体尖端110的最终长度的尺寸可以设计成提供用于滑动配合在锚杆110内,而另一个预定的长度或部件172包括略大的直径或宽度,以提供与锚杆101的压力配合。这继而允许锚杆101与针体110选择性地接合。
图36至38绘制出了具有压配合部件176的锚固系统100的实施例,所述压配合部件176适于将针体110和锚杆101相互锁定,以用于选择性地接合和脱离。在一个实施例中,压配合部件176限制到针体110的一侧或区域,使得当压配合部件176与锚杆101的内部通道102接合时,增加的厚度产生压配合。也公开了压配合部件176的其它变型方案,包括锚杆通道内的内部肋部182和其它结构180,以提供锚杆101与针体110的选择性接合。在图36中,例如,仅在针体110的一侧或区域上而不是围绕针体110周围设置压配合部件176。图37公开了包括突起或短小突出部180的压配合部件176,所述突起或短小突出部180设置在锚杆的内部通道102内,以帮助压配合到针体110。图38公开了一种压配合部件176,其中锚杆101的内部通道102包括多个肋部182,以帮助压配合到针体100。
系统10、100和它们的多种组成部分、结构、部件、材料和方法可以具有先前接合的参考文献中示出和描述的多个适当的构造。
多种材料可以用于形成本文中所述的系统10、100的部分、结构或组成部分,所述多种材料包括镍钛诺、聚合物、弹性体、热塑性弹性体、金属、陶瓷、弹簧、线、塑料管和类似物。
本文中引用的所有专利、专利申请和公布的全部内容通过参照包含于此,好像各个包含于此一样,并且包括那些包含在所述的专利、专利申请和公布中的参考文献。
显然,根据本文的教导,本发明的多种修改和变型方案都是可能的。因此,将应当理解,在所附权利要求书的范围内,可以以本文中具体描述的方式之外的方式实施本发明。
Claims (16)
1.一种手术针体装置,所述手术针体装置包括:
针体组件,所述针体组件包括:
大致固定的针体,所述大致固定的针体具有穿过所述针体限定的内腔;
线,所述线具有远端尖端部分,其中所述线能够沿着针体内腔的至少一部分来回移动;
针体远端端部,所述针体远端端部包括倒钩防护装置,所述倒钩防护装置具有至少一个倒钩构件,所述至少一个倒钩构件延伸超出所述大致固定的针体;
手柄组件,所述手柄组件包括至少一个致动器和偏压构件,其中所述至少一个致动器与所述线和所述偏压构件操作地联接,使得所述偏压构件将所述线的远端尖端部分偏压到与所述针体内腔外侧相距一定距离的延伸的接合位置,同时在激活所述至少一个致动器时,所述远端尖端部分能够收回;和
组织锚杆装置,所述组织锚杆装置具有至少一个延伸的尖齿,所述至少一个延伸的尖齿能够选择性地邻接到停止在所述至少一个倒钩构件上,
其中,所述组织锚杆装置能够在所述倒钩防护装置的远侧接合在针体的远端端部处,并且其中,所述倒钩构件的形状设计成并且构造成与所述延伸的尖齿接合,使得所述倒钩构件减小沿近端方向移动组织锚杆装置穿过组织所需的力。
2.根据权利要求1所述的手术针体装置,其中,所述组织锚杆装置包括穿过所述组织锚杆装置的孔,使得当所述线的远端尖端部分处于所述延伸的接合位置时,所述远端尖端部分延伸通过所述孔并从所述孔延伸出来。
3.根据权利要求1所述的手术针体装置,其中,所述锚杆装置包括两个延伸的尖齿,所述两个延伸的尖齿有助于软组织接合。
4.根据权利要求2所述的手术针体装置,所述手术针体装置还包括悬带植入物,所述悬带植入物与所述锚杆装置联接。
5.根据权利要求4所述的手术针体装置,其中,所述悬带植入物由相容的网状物材料构造。
6.根据权利要求1所述的手术针体装置,其中,所述至少一个致动器包括两个滑动致动器,所述两个滑动致动器与所述偏压构件和所述线操作地联接。
7.根据权利要求1所述的手术针体装置,所述手术针体装置还包括闭锁组件,所述闭锁组件与所述线的远端尖端部分操作相连,所述闭锁组件包括本体部分和邻接部件,所述本体部分具有至少一个延伸的翼状构件,所述至少一个延伸的翼状构件选择地能够与所述手柄组件的一部分接合,所述邻接部件能够接收所述本体部分的至少一部分,使得所述线的远端尖端部分阻止所述针体内腔内的向后行进。
8.根据权利要求7所述的手术针体装置,其中,所述至少一个致动器与所述邻接部件操作地相连,使得所述至少一个致动器的运动致使所述邻接部件抵靠在所述至少一个延伸的翼状构件上,以使所述至少一个延伸的翼状构件与所述手柄组件脱离,使得所述线的远端尖端部分能够在所述针体内腔内收回。
9.一种手术针体系统,所述手术针体系统包括:
组织锚杆,所述组织锚杆具有一个或多个延伸的尖齿;
针体组件,所述针体组件包括:
针体,所述针体具有穿过所述针体限定的内腔;
线,所述线具有远端尖端部分,其中所述线能够沿着针体内腔的至少一部分来回移动;
倒钩防护装置,所述倒钩防护装置具有一对倒钩构件,每个所述倒钩构件都从所述针体侧向地伸出,其中,所述组织锚杆能够在所述倒钩防护装置的远侧接合在针体的远端端部处,其中,所述组织锚杆的延伸的尖齿的后表面能够邻接地停止在所述倒钩防护装置的相应的倒钩构件的前表面上;和
手柄组件,所述手柄组件包括滑动器致动器和偏压构件,其中所述滑动器致动器与所述线和所述偏压构件操作地联接,使得所述偏压构件将所述线的远端尖端部分偏压成与所述针体内腔外侧相距一定距离,以帮助与所述组织锚杆接合,其中在激活所述滑动器致动器时,所述远端尖端部分能够收回,以使所述远端尖端部分从所述组织锚杆脱离。
10.根据权利要求9所述的手术针体系统,所述手术针体系统还包括悬带植入物,所述悬带植入物与所述组织锚杆联接。
11.根据权利要求10所述的手术针体系统,其中,所述悬带植入物由相容的网状物材料构造。
12.根据权利要求9所述的手术针体系统,所述手术针体系统还包括闭锁组件,所述闭锁组件与所述线的远端尖端部分操作地相连,所述闭锁组件包括本体部分和邻接部件,所述本体部分具有至少一个延伸的翼状构件,所述至少一个延伸的翼状构件选择地能与所述手柄组件的一部分接合,所述邻接部件能够面对所述至少一个延伸的翼状构件的至少一部分,使得所述线的远端尖端部分阻止所述针体内腔内的向后行进。
13.根据权利要求12所述的手术针体系统,其中,所述滑动器致动器与所述邻接部件操作地相连,使得所述滑动器致动器的运动致使所述邻接部件抵靠在所述至少一个延伸的翼状构件上,以使所述至少一个延伸的翼状构件从所述手柄组件脱离,使得所述线的远端尖端部分能够在所述针体内腔内收回。
14.根据权利要求12所述的手术针体系统,其中,所述滑动器致动器的近端基部容纳在所述手柄组件内,并且所述邻接部件至少部分地限定在所述滑动器致动器的近端基部内。
15.根据权利要求9所述的手术针体系统,其中,所述针体的近端部分牢固地容纳在所述手柄组件内,使得所述针体基本固定。
16.根据权利要求9所述的手术针体系统,所述手术针体系统还包括用于选择性地附装所述组织锚杆与所述远端尖端部分以及选择性地从所述远端尖端部分分开所述组织锚杆的设备。
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US61/186,616 | 2009-06-12 | ||
PCT/US2009/062197 WO2010051273A1 (en) | 2008-10-27 | 2009-10-27 | Surgical needle and anchor system with retractable features |
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CN102245111B true CN102245111B (zh) | 2014-07-16 |
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CN (1) | CN102245111B (zh) |
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CN102245111A (zh) | 2011-11-16 |
EP2349018A1 (en) | 2011-08-03 |
US8944990B2 (en) | 2015-02-03 |
USD733298S1 (en) | 2015-06-30 |
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AU2009308934A1 (en) | 2010-05-06 |
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US20130217958A1 (en) | 2013-08-22 |
KR101719512B1 (ko) | 2017-04-04 |
CA2742686A1 (en) | 2010-05-06 |
EP2349018B1 (en) | 2018-08-01 |
US20100105979A1 (en) | 2010-04-29 |
WO2010051273A1 (en) | 2010-05-06 |
US20220273296A9 (en) | 2022-09-01 |
AU2009308934B2 (en) | 2015-03-19 |
BRPI0920253A2 (pt) | 2017-06-27 |
US20190298344A1 (en) | 2019-10-03 |
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