CN1893880A - 有关节的脊骨固定杆及系统 - Google Patents
有关节的脊骨固定杆及系统 Download PDFInfo
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- CN1893880A CN1893880A CNA200480027587XA CN200480027587A CN1893880A CN 1893880 A CN1893880 A CN 1893880A CN A200480027587X A CNA200480027587X A CN A200480027587XA CN 200480027587 A CN200480027587 A CN 200480027587A CN 1893880 A CN1893880 A CN 1893880A
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Abstract
本发明总地涉及用于对准和植入矫形固定体或稳定身体内的植入物的系统和方法。在一个实施方式中,该系统包括至少两个骨锚,其中至少一个具有横向孔口和锁定零件。一方面,该系统还包括至少一个连杆,用于通过其各自的锁定零件连接两个或多个骨锚。连杆可以包括至少一个角度可调节关节,可通过驱动锁定零件固定该关节。可锁定骨锚和连杆进入适当位置,形成脊柱融合或固定假体。
Description
技术领域
本发明总地涉及医疗器械,更具体地涉及将矫形固定体或稳定植入物对齐和植入体内的系统。
背景技术
人椎骨及相关连接部分受许多疾病和病症的影响,导致疼痛和失能。这些疾病和病症包括:脊椎关节强硬、脊椎前移、脊椎不稳定性、椎骨的狭窄和退化、突出、或退化和脱出的椎间盘。此外,椎骨及相关连接部分还受包括骨折以及韧带撕裂的损伤和包括椎板切除术的外科手术的影响。
与这些疾病、病症、损伤和手术相关的疼痛和失能常常是所有或部分椎骨从其余脊柱移位的结果。已开发了许多方法,恢复移位的椎骨或部分移位的椎骨至其正常位置并将它们固定在脊柱内。例如,带有螺钉固定的切开复位术是一种目前使用的方法。用销、螺钉、杆和板连接骨的两个或多个部分的骨的外科手术,需要切开骨周围组织,并钻一个或多个通过需要连接的骨部分的孔。由于骨的大小、构型和载荷要求的明显差异,现有领域中已开发了许多骨固定装置。一般来说,目前的医疗标准依赖于许多金属线、螺钉、杆、板和夹,以在治愈或融合过程中稳定骨碎片。然而,这些方法伴有许多缺点,例如病态、高花费、长时间住院及切开手术相关的疼痛。
因此,需要疼痛和潜在并发症较少的复位和固定移位椎骨或部分移位的椎骨的装置和方法。优选地,可通过最小侵入性手术植入该装置。
发明内容
根据本发明的一方面,提供了用于最小侵入性地植入后固定硬件的系统。该系统通常包括至少两个带有横向孔口和锁定零件的骨锚。该系统通常还包括用于通过其各自的孔口连接两个或多个骨锚的连杆。杆至少具有一个角度可调节关节。在许多临床情况下,该杆具有多于一个角度可调节关节。该系统还可包括驱动件,用于使骨锚插入骨中和用锁定零件锁定角度可调节的关节。在一个实施方式中,提供了用于插入连杆的插入工具。可通过将锁定零件锁定在骨锚上,固定骨锚、连杆和关节,以在皮下形成假体。
在本发明的另一方面,可植入的固定杆包括第一区段和第二区段,第一区段具有近端和远端,第二区段具有近端和远端。关节位于第一区段和第二区段之间。关节可在第一状态和第二状态之间转换,第一状态中第一和第二区段相互之间可移动,第二状态中第一和第二区段相互之间固定。
在本发明的另一方面,提供了用于最小侵入性植入后固定硬件的方法。在一个实施方式中,该方法包括将具有锁定零件和横向孔口的第一骨锚插入第一椎体中。将具有锁定零件和横向孔口的第二骨锚插入第二椎体中。第一和第二椎骨可以相邻或通过一个或多个其它椎体隔开。将具有至少一个角度可调节关节的连杆插入通过两个骨锚的孔口。然后,锁定每个骨锚的锁定零件,固定至少一个角度可调节关节的位置,确保连杆在骨锚内,形成假体。
根据本发明的另一方面,该方法还包括将具有横向孔口和锁定零件的另一个骨锚插入另一个椎体。后一椎体可与第一和第二椎体中的一个或两个相邻,也可以与第一和第二椎体隔开。将连杆插入通过骨锚的横向孔口,形成假体。
根据本发明的另一个实施方式,该方法还包括放置一个或多个引导丝。可将引导丝插入骨中,形成插入骨锚的通道。另一个引导丝可穿过两个或多个骨锚的孔口,引导连杆的插入。
在任何上述系统和方法中,引导丝可被柔性导管代替或补充。在本发明的这些操作中,骨锚和/或连杆可通过导管内部推进。
结合附图,参考下面优选实施方式的详细描述,本发明的其它特点和优点对本领域技术人员将显而易见。
附图说明
图1是根据本发明的一个实施方式,最小侵入性后脊柱固定系统的总视图。
图2是图1的骨锚和驱动件的分解图。
图2A是图2圆圈区域的放大图。
图2B显示了根据另一个实施方式的锁帽及其辅助的内部接合件。
图2C显示了根据另一个实施方式的连接件、锁帽及其辅助的内部接合件。
图2D显示了根据另一个实施方式的具有旋转限制的角度可调节连接件。
图2E显示了根据另一个实施方式,位于骨锚头部内的具有旋转限制的角度可调节连接件的剖视图。
图2F-2H显示了另一个实施方式的连接件。
图2I-2L显示了另一个实施方式的连接件。
图3是用于图1所示最小侵入性后脊柱固定的系统的侧视图,其中固定杆脱离插入工具。
图3A是图3所示固定杆的未装配侧视图。
图3B是图3所示固定杆的一部分的装配侧视图,显示了角度调节范围。
图3C是图3所示固定杆的一部分的装配顶视图,显示了角度调节范围。
图4显示了最小侵入性后脊柱固定系统的另一个实施方式的侧视图,其中固定杆脱离其插入工具。
图4A是图4系统的另一视图。
图4B是图3固定杆的未装配侧视图。
图4C显示了另一个实施方式的最小侵入性后脊柱固定系统的侧视图,其中固定杆脱离其插入工具。
图5是图1所示最小侵入性后脊柱固定系统的另一视图,其中连杆脱离其插入工具。
图5A是图5中圆圈区域的放大图。
图6是图1所示最小侵入性后脊柱固定系统的插入工具的另一视图。
图7-12显示了使用定位工具将引导丝定位于椎体内。
图13-14显示了使用膨胀气囊导管扩张组织束。
图15-20显示放置护套邻近椎体。
图21-23显示了用于在椎体中形成孔口以接受骨锚的钻孔器。
图24-25显示了将骨锚在引导丝上向椎体前进。
图26-27显示了用于将骨锚插入椎体内的骨锚和驱动件。
图28-31显示了使用驱动件将骨锚插入椎体内。
图32显示了位于两相邻椎体中的两个骨锚。
图33是位置通过两相邻骨锚的引导丝的侧方前立体图。
图34显示了根据本发明的一方面,将引导丝放置通过骨锚的对齐装置。
图35显示了用于定位在对齐装置的弓形臂内的柔性闭孔器。
图36显示了结合第一骨锚的第一对齐装置和结合第二骨锚的第二对齐装置。
图37显示了用于定位在对齐装置上的弓形臂内的引导丝接纳装置。
图38显示第一和第二对齐装置,引导丝从第一对齐装置向第二对齐装置携带的接纳装置推进。
图39是类似图38的视图,引导丝进入引导丝接纳装置并穿过第二对齐装置的曲线臂之后。
图40是位于引导丝上的连杆的侧视图。
图41是类似图32的视图,其中连杆位于第一和第二骨锚内。
图42是类似图32的视图,其中放置驱动件以将第一骨锚锁定于连杆。
图43是类似图32的视图,其中驱动件工具的一部分向近端收缩。
图44是类似图43的视图,其中驱动件工具收缩,第一和第二骨锚被锁定在连杆上。
图45是类似图44的视图,其中插入工具与连杆脱离。
图46是类似图45的视图,其中从连杆去除了插入工具和引导丝,显示了根据本发明形成在适当位置中的一级后融合装置。
图47是类似图45的视图,显示了根据本发明的在皮下装配的两级融合或固定装置。
具体实施方式
虽然将主要在脊柱固定过程的内容中描述本发明的应用,但是本文所述系统和方法可用于可能需要连接、膨胀、支撑、支持、固定或其它假体的最小侵入性植入的许多医学应用。本文所述系统和方法也可用于用于需要将柔性构型的植入物引入体内,然后使植入物转化为基本刚性构型(例如,用夹板夹住或稳定折断或骨折的骨)的多种医疗过程。
在本发明多个实施方式中叙述的假体形成的优点之一是,能够通过最小侵入性通道到达治疗部位,并允许在治疗部位形成相对较大的假体。在一个实施方式中,将假体的各组件通过最小侵入性通道插入患者,然后连接以形成单一假体。这可通过提供带有角度可调节关节的连杆以便于进行,随着连杆穿过多个骨锚提供灵活性和角度可调节性。然后,可锁定连杆中的关节,以将连杆固定或设定为所需构型。
几个实施方式必然产生的优点是,能够放松和调节连杆中的关节,以在其植入和形成期间或之后,将假体设定为其它所需构型。这样,可在后续过程中调节假体。
根据本发明的多个实施方式,用于脊柱固定的系统和方法可通过避免开放的外科切口或其它侵入性通道手术,最大程度地降低手术发病。基础经皮通路、骨螺钉构造和植入方法,以及经皮定位固定杆穿过骨螺钉的方法和结构,所有这些对于实践本发明是有用的,公开于Teitelbaum于2000年12月21日提交的美国专利申请序列号09/747,066,题为经皮脊骨融合系统(PercutaneousVertebral Fusion System);Shaoliaii等于2001年8月29日提交的美国专利申请序列号09/943,636,题为可成形矫形固定系统(Formable Orthopedic FixationSystem);Teitelbaum等于2001年10月10日提交的美国专利申请序列号09/976,459,题为交联的可成形矫形固定系统(Formable Orthopedic FixationSystem with Cross-Linking);和Shaolian等于2002年5月31日提交的美国专利申请序列号10/161,554,题为热加速的原位成形固定系统(Formed in PlaceFixation System with Thermal Acceleration);于2003年6月13日提交的美国专利申请序列号10/_,_,代理人摘要VLINK.021A,题为最小侵入性后固定系统和方法(System and Method for Minimally Invasive Posterior Fixation),所有这些专利的内容被纳入本文作为参考。
图1提供了根据本发明的一个实施方式的最小侵入性后脊柱固定系统的总体视图。该系统包括至少两个及任选地三个或四个或更多个骨锚100和关节连接的连杆200。在图1,通过连杆200连接所示各骨锚。该系统还可包括啮合其中一个骨锚100的驱动件150和结合于连杆200的插入工具250。虽然这些组件将主要在结合两个骨锚的单连杆中叙述,一般融合应用典型地将涉及植入两个连杆,每个连杆由两个或多个骨锚装载,并两侧对称地固定在脊柱上,如本领域所理解的那样。
图2显示了骨锚100和驱动件150的放大图。骨锚100带有螺纹102,通过螺纹将其拧入椎体中。锁帽106位于骨锚100的头部108内。
驱动件150包括围绕内接合件154中心放置的外接合件152。一个接合件可以相对于另一个自由旋转。外接合件152适合啮合头部108,以将骨锚100拧入骨中。内接合件154适合啮合锁帽106,以将固定杆200固定在头部108内。在一个实施方式中,外接合件152的六角形近端156允许可通过扳手、紧固扳手或其它工具,施加扭矩于外接合件152。类似地,内接合件154的六角形近端158允许可施加扭矩于内接合件154。
可以许多方式实现驱动件和骨锚之间可释放的可旋转的啮合。在所示实施方式中,内接合件154的远端具有至少一个表面,用于配合骨锚100的近端上的互补表面,将扭矩从内接合件154传递至骨锚100,以将扭矩从内接合件154传递至锁帽106。类似地,外接合件152的远端具有至少一个表面,用于配合骨锚100的近端上的互补表面,以将扭矩从外接合件152传递至骨锚100,以使骨锚100和椎体之间可靠啮合。
在一个实施方式中,骨锚100、其锁帽106和内接合件154都具有中心轴线腔,引导丝190可穿过这些中心轴线腔。
图2A是图2中圆圈区域的放大图,显示骨锚100的近端头部108以及外接合件152和内接合件154的远端。所示锁帽106在头部108之外。
横向孔口116沿接近垂直于骨锚100的中心轴线的轴线延伸通过头部108。虽然所示头部108的横向孔口116是圆形的,它在其它实施方式中也可以是其它形状,取决于固定杆的横截面形状(例如,卵形、椭圆形、矩形、正方形等)。横向孔口116的直径通常大于固定杆200的对应部分的直径,使得在拧紧锁帽106之前,至少一部分固定杆200可插入通过孔口116。在所示实施方式中,孔口116包括头部108内的轨道或凹槽114。凹槽114的优选轮廓略大于固定杆200的对应部分的直径,但比孔口116的直径较小。在其它实施方式中,可从横向孔口116消除凹槽114。
图2B类似于上述图2A,显示了另一个实施方式的内接合件154’和锁帽106’。在一个实施方式中,内接合件154’具有Torx远端158’,该远端适合于啮合锁帽106’顶端的互补Torx孔口120’。可使用许多互补的表面结构的任一个,如参考本说明书将理解的那样。
在再一个实施方式中,骨锚100的头部108还可具有角度可调节连接件104,如图2C所示。连接件104位于锁帽106下的头部108内。在一个实施方式中,连接件104为球形,并具有延伸通过其中的孔110,在它的圆周中具有缝隙112,使得沿孔110的中心轴线来看,连接件接近C形。孔110适合插入连杆(未示出),它的直径略大于连杆的直径。本领域技术人员将理解,连接件104可为多种合适的形状。
在一个实施方式中,连接件104位于如上所述的头部108中的轨道或凹槽114上。在该实施方式中,凹槽114优选具有与连接件104的球形外表面互补的表面。连接件104可绕骨锚(或骨螺钉)100的头部108内的任何一轴线旋转。锁帽106可拧入头部108,以将连接件104锁定于连杆200,通过压缩凹槽114,将连接件104固定在头部108内。锁帽106的底部可为与连接件104的球形外表面互补的凹面(未示出),。
虽然所示连接件104的孔110是圆形的,它们在其它实施方式中可以是其它形状,取决于固定杆的横截面形状(例如,卵形、椭圆形、矩形、正方形等)。横向孔口116的直径通常小于未压缩连接件104的外径,但大于孔110的内径。在拧紧锁帽106之前,连接件104可绕头部108内的任何一轴线旋转,以适应用于固定杆的不同进入角度。这样,孔110的中心轴线和横向孔口116的中心轴线可以是同轴线或角度偏移。
在一个实施方式中,将锁帽106拧入头部108,压缩连接件104,减小缝隙112的宽度且减小孔110的截面积。这使延伸通过骨锚100的横向孔口116的连杆(未示出)轨道在孔110内。将锁帽106拧紧入头部108也可将连接件104的旋转位置固定在头部108内。
图2D显示了另一种连接件104’。类似于上述连接件104,连接件104’具有孔110’,它具有纵轴线和缝隙112’。连接件104’的球形外表面具有一个或两个或三个或多个表面结构、如凸起或凹陷111。凹陷111接受互补表面结构、如骨锚100头部108内的凸起,以限制连接件104’在头部108内的旋转角度。例如,图2E显示了示例性实施方式,其中,互补表面结构包括销钉101,该销钉可以与螺钉头部108激光焊接或其它结合或整体成形。如上所述,销钉101与凹陷111相互作用,以限制头部108内连接件104’的旋转角度。在一个具体实施方式中,连接件104’绕头部108内的任何轴线的旋转被限制在离开横向孔口116纵轴线的约30度。在另一个实施方式中,连接件104’可被限制在离开该纵轴线大到约60度的旋转范围。在一个实施方式中,连接件104’被限制在任何轴线上旋转离开该纵轴线的不大于约5度或约10度。一般来说,限制连接件104’的旋转总是通过横向孔口116暴露该孔至连杆200。
图2F显示了另一个实施方式的连接件104″。类似于上述连接件104和104’,连接件104″具有孔110″和一个或多个可压缩缝隙112″。缝隙112″具有可压缩材料,当锁帽106’将连接件104″锁紧在头部108的凹槽114内时该可压缩材料收缩。本发明几个实施方式中可使用可压缩材料,包括医疗器械领域已知的任何类型的可压缩聚合材料。本领域技术人员将理解,也可使用其它合适的柔性或可压缩材料。此外,许多类型金属(例如不锈钢、钛)的任一种的连接件104的形状使孔110可从接受连杆200通过其中的第一、大截面向第二用于在适当位置锁定连杆200的缩小的截面移动。这可通过以下方式实现:提供相对的组成部分,形成连接件104侧壁,并具有多种类型的互锁结构的任一种,如斜面和棘爪棘轮结构,或在锁帽106的压力下可使孔110直径减小的滑动配合结构。
在可选的实施方式中,部分或全部连接件104包括可压缩介质如开室泡沫材料、闭室泡沫材料或固体可压缩材料。取决于构造和所需压缩性,可使用包含聚乙烯、PEEK、尼龙和医疗器械领域已知的其它聚合物结构。一般来说,连接件104的材料和结构的组合足以实现孔110纵轴线的角度调节,以使连杆200具有各种进入角度。将连杆200放置于孔110内后,锁定零件如锁帽106的旋转和/或轴向运动具有以下两种作用:防止连杆200在孔100中的轴向移动,以及进一步防止孔110纵轴线相对于骨锚110纵轴线的角度调节。
图2G-2H更详细地显示了连接件104″、孔110″、缝隙112″和可压缩的或可折叠的膜或连接部分115。图2F是连接件104″的等立体图。图2G是沿孔110″的中心轴线观察的连接件104″的前视图。图2H是对应的侧视图。在图2F-2H所示实施方式中,通过磨削、激光蚀刻、模制形成可压缩连接部分,或形成凹面如V形通道113、保留薄连接部分115,使得当压缩连接件104″时薄连接部分115被折平。本领域技术人员将理解,可压缩材料和结构可具有多种合适的形状和形式。
在一个实施方式中,孔110’和110″倾向于回到其原来的直径,即使是在锁帽106分别依靠头部108的凹槽114压缩连接件104和104’之后。这种趋势是制造连接件104和104’的金属、合金或其它材料的回柔性的结果。在连接件104″的缝隙112″中使用可压缩材料如V-形通道113可降低或消除这种趋势,并使连杆(未示出)更稳固地固定在孔110″内。本领域技术人员将理解,连接件104和104’可由低回柔性材料构成,这可降低或消除孔110’和110″回到其原始直径的趋势。
图2I-L显示了另一个实施方式的连接件104。在该实施方式中,连接件104具有以使所述的孔110和凹陷111。连接件104的顶部为可压缩材料或可折叠连接部分117,其中包括形成进入连接件104主体的一系列V形通道。在所示构型中,通道包括一系列在连接件104的外表面上形成的40度V-形通道119,和一系列在连接件104的内表面上形成的20度V形通道121。以类似的方式,连接件104的较低部分上具有可折叠连接部分123。在本实施方式中,随着锁紧锁帽106,连接件104的顶部和底部变形,侧向被压缩以将固定杆固定在孔110内。
采用连接件104的骨锚的进一步细节和其它实施方式参见与2003年6月13日提交的待批美国专利申请序列号10/_,_,代理人摘要VLINK.021A,题为最小侵入性后固定系统和方法(System and Method for Minimally InvasivePosterior Fixation),其内容被纳入本文作为参考。
如上文参考图2所述,在一个实施方式中,外接合件152适合啮合头部108,内接合件154适合啮合锁帽106。在所示实施方式中,外接合件152远端上的凸起156适合啮合骨锚100头部108上的互补凸起118。内接合件154的六角形远端158适合啮合锁帽106顶部的互补六角形孔口120。
虽然这里描述了驱动件150和骨锚100之间的具体互锁关系,本发明者们还考虑了多种改变。例如,对于内接合件154或外接合件152或两者,可颠倒在驱动件和植入物之间的阳-阴关系。此外,每个内接合件154和外接合件152都具有与植入物上的相应组成部分转动啮合的表面结构。虽然这可通过使用对应的六角形阳和阴组成部分容易地实现,但也可采用许多类型的可选结构,其中内接合件154或外接合件152上的第一表面与骨锚110对应部分上的互补表面匹配,以实现旋转啮合,然后轴向分离。
现在参考图3和3A,将更详细地描述关节固定杆200。固定杆200优选包括第一区段204、第二区段206和中心腔202,其构型可接受引导丝,下面将更详细地描述。第一和第二区段204,206通过角度可调节关节208a结合在一起。
如下面将更详细地描述的那样,固定杆200可具有一个或多个关节208a。关节208a使固定杆200具有一定的灵活性,允许固定杆200通过非直线、不连贯的和/或曲线途径运动。这对于使固定杆200插入通过许多骨锚100的横向孔口116尤其有利。例如,通常难以使多个骨锚100的横向孔口116相互对准,这是因为脊柱表面一般是非平面和非均一的。这样,每个骨锚100可以于不同角度取向和/或高度从脊柱延伸。尤其难以对准L5椎骨中的锚与S1椎骨(即骶骨)中的锚之间的诸孔口。
因此,难以拧入通过一个以上的骨锚100的诸横向孔口116的直或甚至弯曲的固定杆。在非最小侵入性手术中,外科医生可测定诸骨锚100之间的非对准角度,弯曲固定装置和/或调节骨锚在脊柱中的位置。然而,在最小侵入性手术中,这种调节是不现实的,这是因为它们可导致延长患者暴露于和使用荧光辐射的时间。
虽然下面将详细描述关节连接的具体构型,但可采用多种结构实施本发明。一般来说,可植入的固定杆具有至少第一区段和第二区段,杆在第一状态下,第一和第二区段相互之间角度可调节,而当杆在第二状态下,它们之间相互固定。这使得,例如,当杆为第一状态时,可沿非直线途径皮下引入到患者的治疗部位。然后,杆可转化为第二状态,使其具有足够的刚性以产生所需的临床结果。这可使第一骨或骨片段相对于第二骨或骨片段刚性固定。
第一和第二区段通常由界面隔开,其中第一区段上的第一结合或界面表面与第二区段上第二互补结合或界面表面接触。这种类型界面的一个例子是球形和插口形关节,如下所述。也可形成另一种界面:例如,通过板弹簧型结构,或其它轴向零件结构,例如两个或多个通常轴向延伸的零件,这些零件相互之间可活动以实现弯曲,但通过侧向压缩相互之间锁定。
关节连接可以许多方式从活动状态转化为固定状态。一种方便的固定方式是响应可以施加的侧向压缩,例如,通过骨锚所携带的轴向移动组件(例如,螺纹轴如一套螺钉)。这样,在阳零件装配在互补阴零件内的球形和插口形结构中,外阴零件上的表面可依靠着阳零件上的互补表面弯曲或侧向向内压缩,使固定。互补表面中的一个或两个都可具有增加摩擦表面结构,如脊、打毛或微点蚀,如本领域技术人员参考本说明书将理解的那样。
参考图3和3A,关节208a包括第一区段204上形成的第一表面210和第二区段206上形成的第二互补表面。在所示实施方式中,第一表面包括插口或凹面214,第二表面包括球220,以在第一和第二区段204,206的相邻端点间形成球形关节。第一区段204包括插口部分210,插口部分包括通常为圆柱形的外表面212,其构型可延伸入骨锚100的横向孔口116中。插口部分210近端包括通常为球形的插口或凹面214。该插口部分210具有至少一个缝隙216。在所示实施方式中,至少一个缝隙216从外表面212的一侧延伸通过中心腔202并到达外表面212的对侧,因而通常将插口部分210分成两半。压缩缝隙216可减小插口214的横截面直径并固定关节208a的角度位置,如下面详细描述的那样。
插口部分214的形状可接受第二区段206远端上的球220或球形凸起。在一个实施方式中,球220被构造成可压配入插口214。也就是说,插口214形成孔口222,孔口222在松驰状态时直径小于球220的直径。在该方式中,随着将球220插入插口214中,缝隙216扩张,以增加孔口222的直径并使球220插入插口218中。优选地,一旦处于适当的位置,球220相对于插口214的轴向移动被限制,同时允许球220相对于插口216的至少有限的角度调节。这可通过以下方式实现:插口216的的直径略大于球220和/或关节208a的形状使得球220和插口214之间的摩擦允许角度调节。在该方式中,可调节第一和第二区段204,206之间的角度取向。
在所示实施方式中,可调节第二区段206至在一锥形内形成的许多角度取向的任一个,该圆锥体内具有通常位于插口214和球220的中心的顶点ν。角α(见图3B和3C)表示两区段之间的角度调节,主要由插口部分204的近端和球220近端上的颈部224之间的界面限定。通过降低颈部224的直径可增加此角度。应理解,第一和第二区段的纵轴线b,c之间的最大角度调节通常是顶点角α的一半。
取决于使用的环境,顶点角α优选在约15-90度的范围内,并且,第二区段206相对于第一区段204的纵轴线之间的角α可在这圆锥体内旋转至任何角度取向。在一个实施方式中,对于位于腰部高度的关节208,顶点角α约为15-30度的范围内,对于位于L5和S1高度的关节208,顶点角α约为45-90度的范围内。在另一个实施方式中,在腰部高度,杆200可固定(例如,不用关节形成),而在L5和S1高度,关节208的顶点可约为45-90度的范围内。
本领域技术人员将理解,在其它实施方式中,所示球关节可被许多其它类型的角度可调节结构如铰链或其它提供角度调节的滑动结构所替代。例如,可以按几种不同的方式改变插口和/或球的形状,而仍然具有上述角度可调节性。在一个具体的实施方式中,该改变和/或限制角度可调节性。这可通过以下方式实现:球220的球形外表面具有一个或两个或三个或更多个表面结构如凸起或凹陷。凹陷接受互补表面结构如插口214内的凸起,以限制球220在插口214和/或平面内的旋转角度,通过该平面可以调节角度取向。例如,在一个实施方式中,可仅仅通过一个平面(即水平面)在角度方向上调节第一和第二区段。
在所示实施方式中,插口部分210被构造成装配在头部108内的横向孔口116内(见图2-2B)或通过连接件104中的孔110(见图2C)。横向孔口116或孔104优选具有对插口部分210的圆柱形外表面212互补的表面。随着插口部分210穿过头部108,球220相对于插口214旋转可以调节第二区段206相对于第一区段204的角度取向。可将锁帽106拧入头部108,通过对着插口部分210或连接件105的外表面作用并将球220固定在插口214内,以锁定第一和第二区段204,206间的角度取向。锁帽106的底部可具有凹形表面(未示出),它与插口部分210或连接件的球形外表面212互补。
在一个实施方式中,将锁帽106拧入头部108可压缩插口部分210,减小缝隙216的宽度和减小插口214的截面积。这将球220固定在插口214内并固定第一区段204相对于第二区段206的角度取向。在使用连接件104的实施方式中,锁帽还可将连接件104在头部108内的角度位置固定。在一些实施方式中,可打毛、蚀刻(例如,机械、电、光电、化学等)和/或用材料涂覆插口214和/或球220,以增加这些组件间的摩擦。在该方式中,插口214和球220间的锁紧力增加。这种技术还可应用于连接件104和第一区段204的外表面。
在所示实施方式中,锁帽106还可将插口部分210的轴向位置固定在骨锚100内。然而,在修饰的实施方式中,这可通过单独的装置(例如一套螺钉)来实现。
一般对于腰椎应用,在锁定位置中,固定杆200优选地具有静态压力约为120-200lbs,更优选地大于约150lbs,该杆优选地具有静态扭矩约为15-25英寸磅,更优选地超过约20英寸磅。5Hz下,该杆将优选达到至少约5百万周波。一般对于颈椎应用,在锁定位置中,固定杆200优选地具有静态压力约为30-100lbs,更优选地大于约80lbs,该杆将优选地具有静态扭矩约为10-20英寸磅,更优选地超过约15英寸磅。5Hz下,该杆将优选达到至少约5百万周波。所有这些参数都是根据美国材料试验学会(American Society for Testing andMaterials(ASTM))规定方法F 1717-96中描述的方案测定,其全部内容被纳入本文作为参考。
如上所述,插口部分210和插口部分中形成的对应缝隙216优选的长度约为10-30毫米。这对关节208a提供了工作范围,其中锁帽106可用于固定关节208a的角度取向。也就是说,锁帽106可用于固定关节208a的角度取向,只要至少一部分插口部分210位于头部108中使得锁帽106压缩缝隙216。
对于单级应用,典型地将两个骨锚100插入相邻椎骨。在这种应用中,固定杆200优选包括两个关节208a,208b。如图3A所示,可在第二区段206的近端和第三或末端区段230的远端之间形成第二关节208b。在所示实施方式中,第二区段206的近端包括球形凸起或球220,其形状如上所述。末端区段230包括插口部分210,其构型如上所述,包括插口214以接受第二区段206的球220。
如图3所示,连杆200的第一区段204可具有锥形远端232。可以制造锥形远端232和作为区段204的整体部分,可以与插口部分210整体模制,或单独地形成并结合于连杆200。在一个实施过程中,锥形端232可以是聚合成分如尼龙、HDPE、PEBAX或本领域的其它已知材料。锥形端232有利于将连杆200推入推过横向孔口116。在其它实施方式中,远端232可以是圆钝的或球形,以最大程度地减小杆200从最远端锚110的孔口116的超出部分。在某些应用中,这种实施方式可有益地降低杆200远端与S1椎体之间的干扰。
继续参考图3,末端区段230可以包括六角形近端234。六角形近端234可连接插入工具,下面将更详细地描述。
用于成人单级腰椎或腰骶融合装置中的连杆200的长度通常约为30-90毫米,通常具有平均直径约为5.5-9毫米的圆形截面。在该实施方式中,第一区段204和末端区段230的长度通常约为10-40毫米。缝隙216的宽度通常约为0.5-1.5毫米,长度约为9-29毫米。插口部分210的长度通常约为10-30毫米。第二区段206的长度通常约为10-10毫米。插口214和球220的直径约为5.0-7.0毫米。
在两级应用中,典型地将三个骨锚100插入相邻椎骨中。在这种应用中,固定杆200’优选地包括四个关节208a,208b,208c,208d。见图4、4A和4B。如图所示,在图4B中,通过增加第四或中间区段238和附加的第二区段240,可以提供四个关节208a-d,其形状如上所述。紧接着的区段240包括位于区段240远端和近端的两个插口214,和延伸通过区段240整个长度的缝隙216。外表面212被构造成装配在骨锚中(见图4A),使得拧紧锁帽106可压缩中间区段238中的插口214,从而固定相应的关节208b,208c。
用于成人两级腰椎或腰骶融合装置中的连杆200’的长度通常约为70-120毫米,通常具有平均直径约为5.0-9.0毫米的圆形截面。在该实施方式中,第一区段204和末端区段230的长度通常约为10-40毫米。缝隙216的长度通常约为9-29毫米,插口部分210的长度通常约为10-30毫米。第二和中间区段206,240的长度通常约为10-40毫米。插口214和球220的直径约为5.0-7.0毫米。
在脊柱的胸椎段和颈椎段的治疗中使用的两级融合的连杆200的另一个实施方式中,杆200的长度约为100-240毫米,通常具有平均直径约为3-4毫米的圆形截面。在该实施方式中,第一区段204和末端区段230的长度通常约为10-40毫米。缝隙216的长度通常约为9-29毫米,插口部分216的长度通常约为10-30毫米。第二和中间区段206,240的长度通常约为10-40毫米。插口214和球220的直径约为5-7毫米。
图4C显示了固定杆200″修饰的实施方式。该实施方式尤其适用于骶-腰融合的两级装置。在该实施方式中,杆200″包括至少一个关节208a,优选在远端和中间骨锚100之间包括两个关节208a,208b,而中间和近端骨锚100间的固定杆200″是固定的(例如,无关节)。这样,在该修饰的实施方式中,近端和末端部分230’可比图3所示的实施方式较长,使其可延伸通过中间和近端骨锚100。取决于临床应用,末端部分230’可以是基本上是直的、部分弯曲的或弯曲的。在该实施方式中,近端锚100中的锁帽106仅仅将杆200″固定在横向孔口116内。
在上述实施方式中,取决于最终植入物所需的结构整体性,可改变杆200的截面积,在圆形截面实施方式中也可表示为直径。骨锚100的直径约为3.5-4毫米,长度约为10-55毫米。
在修饰的实施方式中,固定杆200中的缝隙216可以具有可压缩材料,当将锁帽106拧紧头部108内的圆柱体部分时,该材料压缩。本发明几个实施方式中可使用可压缩材料,包括医疗器械领域已知的多种可压缩聚合材料。本领域技术人员应理解,可也使用其它合适的柔性或可压缩材料。此外,多种金属(不锈钢、钛等)连接件的任何一个的形状可使插口214从允许球220移动通过的第一、大截面转化为锁定球220角度位置的第二、缩小的截面。这可通过以下方式实现:在相对的插口部分210中提供多种互锁结构的任一种,如斜面和棘爪棘轮结构,或在锁帽106的压力下可使插口214直径减小的滑动配合结构。
在一个修饰的实施方式中,部分或所有插口部分210包含可压缩介质,例如开室泡沫材料、闭室泡沫材料或固体可压缩材料。取决于构造和所需压缩性,可使用包含聚乙烯、PEEK、尼龙和医疗器械领域已知的其它聚合物的结构。一般来说,插口214的材料和结构的组合足以实现球220和插口214的纵轴线的角度调节,形成具有角度可调节关节208的连杆200。将插口部分214定位于横向孔口116内后,锁定零件如锁帽106的旋转和/或轴向运动具有以下两种作用:防止连杆200在孔116中的轴向移动,以及防止关节208的进一步角度调节。
在一个实施方式中,插口214倾向于回到其原来的直径,甚至在头部108内锁帽106对圆柱形部分210相应地加压之后。这种趋势是制造圆柱形部分的金属、合金或其它材料的回柔性的结果。在缝隙216中使用可压缩材料如V-形通道113可降低或消除这种趋势,并使连杆200和关节208更牢固地被固定。本领域技术人员将理解,插口214可由低回柔性材料构成,也可降低或消除插口214回到其原始直径的趋势。
在图5中,连杆200位于两相邻骨锚100之间,与插入工具250隔开。插入工具250用于将连杆200插入骨锚100中。插入工具250包括臂252和手柄254。在所示实施方式中,臂252是弯曲的,以便在患者内沿着通过至少每个第一骨锚和第二骨锚的孔110的弯曲的组织束,将连杆200插入的骨锚100中。然而,应理解在修饰的实施方式中,臂252可以是其它形状(例如直的),插入通过其它形状的组织束。
中心控制线256(大部分都以虚线表示)如扭矩传递管、杆或索延伸通过插入工具250的轴向腔,终止于插入工具250近端的控制件如旋钮258。将螺钉(未示出)拧入沿旋钮258径向延伸的通道260中,用于将控制线256固定在旋钮258内。控制线256具有螺纹末端262。旋转旋钮258而旋转控制线256及其螺纹末端262,以与连杆200啮合或脱离。
在一个实施方式中,连杆200和控制线256都具有中心轴线腔,用于在引导丝上方形成通道。
图5A是图5圆形区域的放大图,显示了外接合件152的远端、骨锚100、连杆200和插入工具的臂252的远端。连杆200被示为固定在骨锚100的头部108内。
如上所述,连杆200具有六角形近端234,适于啮合插入工具臂252远端的互补六角形插口(未示出)。在一些实施方式中,连杆200和臂252上可具有另一种互补表面结构,用于旋转固定它们相互之间的取向。在所示实施方式中,六角形近端234具有浅凹235,适于配合插入工具的臂252远端的六角形插口(未示出)内的互补小块(未示出)。浅凹235和小块(未示出)固定连杆200相对于臂252的轴线取向。控制线256的螺纹末端tip 262可拧入连杆200六角形近端234中的互补螺纹孔237中,使连杆200可拆卸式固定于插入工具的臂252。通过旋转插入工具近端处的旋钮(未示出),可将螺纹末端262拧入螺纹孔206中。从螺纹孔206拧出螺纹末端262使连杆200与插入工具250分开。
继续参考图5A,在所示实施方式中,外接合件152具有沿直径延伸的孔口160,用于外接合件152旋转取向的荧光或其它视觉观察,以对齐由外接合件152啮合的骨锚100的横向孔口116。朝向这一端,孔口160的轴线优选地与横向孔口116的轴线呈直角,如图5A所示。为观察外接合件152和骨锚100的轴位置,可暂时缩回内接合件154,使其不阻塞孔口160。在另一个实施方式中,孔口160中可按装半透明标记物,用于外接合件152的荧光或其它观察。
或者,可提供骨锚100的旋转取向的许多其它表示的任一个。例如,骨锚100近端和插入工具250远端之间的互补表面结构可以被构造成只允许两个部分间的连接在预定旋转取向中。在这种结构中,可提供保留在患者外的插入工具250的一部分的视觉指标(例如,“T”手柄,油漆或蚀刻标记或其它指标),以实现横向孔口116纵轴线旋转取向的直接肉眼观察。
图6从另一角度显示了所述插入工具。除去了旋钮及它的连接的中心索,以便清楚显示。六角形插口264适于啮合连杆的六角形近端(未示出),如上所述。小块266适于啮合连杆六角形近端(未示出)上的浅凹(未示出)。
在一些实施方式中,骨锚、连杆、驱动件以及插入工具的臂可由钛、不锈钢或任何其它合适的金属、合金或材料构成。插入工具的手柄优选由合适的防滑材料形成。本领域技术人员已知制造上述实施方式中描述的零件和装置的材料的选择。
参考图7-47,在脊柱固定手术内容中描述了按照本发明实施方式的最小侵入性地植入后固定硬件的方法。关于该方法的其它细节公开于前述被纳入本文作为参考的待批专利申请。虽然本发明方法和器械可用于开放式外科手术,但是本发明最好应用于经皮或最小侵入性手术。因此,以下方法步骤和被纳入本文作为参考的待批专利申请中的描述,用于经组织的手术。然而,为简化图示,下述图中没有显示治疗部位附近的软组织。
在图7和8中,将套针300插入通过组织束并进入椎体310。套针300包括尖头杆308(见图16),尖头杆连接于近端或上半手柄302。尖头杆308集中设置在套管304内,套管连接于套针300的下半手柄306。将套针300的上半手柄302和下半手柄306拧在一起供起始使用,如图7-8所示。将套针300插入套管患者的皮肤、肌肉和其它组织,进入椎体310。
图9显示了下半手柄306,连接的套管304嵌入椎体310内。上半手柄(未示出)已拧出,并与下半手柄306分开。在图10中,将引导丝312通过下半手柄306和套管304插入椎体310中。
在图11中,从椎体310除去下半手柄306和套管304。优选地,引导丝312保留在椎体310中的适当位置中。
图12显示在去除下半手柄306和套管304后椎体310中的引导丝312。
图13-14显示了应用的一个实施方式的其中使用了可膨胀的组织扩张器用于扩大使用的组织束。在图13中,将带有气囊316的气囊导管314在引导丝312上向椎体310推进。在图14中,膨胀气囊316以扩张与到达椎体310的通道相邻的组织。这提供了扩张的通路,用于插入护套,如下所述。
在图15中,将导管322在引导丝312上前进进入椎体310中。如图16所示,在一个实施方式中,导管322的直径约等于套针300的套管304的直径,使得导管322可插入早先由套针300形成的椎体310的孔口中。导管322用作稳定轨道,在该轨道上可使锥形的扩张圆筒324前进抵靠着椎体310。
在图16-17中,将锥形的扩张圆筒324在导管322上前进抵靠着椎体310。在一个实施方式中,锥形的扩张圆筒324的直径约等于上述图13-14中膨胀的扩张气囊316的直径。锥形的扩张圆筒324用于占据扩张气囊产生的通路,以利于护套的插入。在另一种顺序中,扩张圆筒324可没有锥形的末端,向远端前进进入在可膨胀气囊上的位置。
在图18-20中,将护套320在锥形扩张圆筒324上前进抵靠着椎体310。护套320占据了扩张气囊产生的通道。然后,除去导管322和锥形扩张圆筒324。如图20所示,放置护套320后,优选地引导丝312保留在椎体310内。
在图21-23中,将带有旋转式末端332的钻孔器330在引导丝312上前进并通过护套320。钻孔器330在椎体310中钻出适合插入骨锚100的孔口(未示出)。然后,除去钻孔器330。在图24-25中,将骨锚100在引导丝312上前进并通过护套320,向椎体310推进。
在图24和25中,将骨锚100在引导丝312上前进并通过护套320进入与椎体310啮合。虽然未示出插入工具250,在使骨锚100前进与椎体310接触的步骤之前,可将骨锚100与插入工具250连接。
图26和27显示了驱动件150的外接合件152和内接合件154,以及骨锚100,锁帽106位于骨锚100的头部108内。参考图2和2A,已详细描述了这些零件的相互关系。图26-28中所示的外接合件152还包括枢转孔153,该孔延伸通过外接合件152的直径。枢转孔153适于接合引导丝插入工具400,下面将详细描述。在图28中,这些零件被示为设置在引导丝190上。
在图28中,将驱动件150(包括外接合件152和内接合件154)上引导丝312前进直到驱动件150啮合骨锚100。在图29和30中,在外接合件152上应用扭矩,将骨锚100拧入椎体310。在图31中,除去驱动件150,原位保留骨锚100,横向孔口116的纵轴线116大约平行于脊柱的纵轴线。参考图18-25所述的、但在图28-31所讨论的步骤中未示出的护套320在这些步骤中可用于掩蔽驱动件与相邻组织隔开,如本领域技术人员所理解的那样。
在图32中,将第二骨锚340插入另一个椎体350中。虽然骨锚100和340被示为分别插入相邻椎体310和50,按照本发明实施方式的最小侵入性脊柱固定系统和方法也可应用于非相邻的诸椎体。例如,第一骨锚可位于第一椎体中,如上所述。第二骨锚可位于第二椎体中,第二椎体通过一个或多个居于中间的第三椎体与第一椎体隔开。可通过植入连杆200连接第一和第二骨锚。或者,第三骨锚可位于第三椎体中,第三椎体位于第一和第二椎体之间,以形成三级融合系统,如下所述。
优选地,骨锚定位在适当位置之后,将引导丝368(见图33)推入通过骨锚100和340的横向孔口118。本领域已知多种插入引导丝的方法,本发明并不限于某一具体方法。相反,本发明可使用多种本领域技术人员已知的引导丝插入方法和装置。
图34-40显示了一个实施方式的尤其有利的引导丝插入装置400。引导丝插入装置包括手柄410和空心进针450。手柄410与驱动件150的外接合件152可拆卸地连接。手柄410在其近端412分叉。每个分叉具有枢转销钉414,该销钉啮合外接合件152的枢转孔153(图28)。手柄410的分叉近端可略微分开以使枢转销钉414啮合枢转孔153。手柄410在驱动件150外接合件152的枢转孔153处的枢转销钉414上摆动,以使进针450插入通过骨锚100的横向孔口116。
空心进针450连接于手柄410的远端416。在一个实施方式中,进针450位于手柄410远端416处的孔口418内。将螺钉(未示出)拧入通过手柄410远端416处的螺钉孔420,以使进针450紧固在孔口418内。因此可调节进针450在孔口418内的长度位置,以使进针450通过骨锚100的横向孔口116。在一个实施方式中,进针450可在比横向孔口116的中心更低的点(朝向图2中的螺纹102)通过横向孔口116,这是因为体内插入进针450中遇到的障碍可使针450向其曲率内部和横向孔口116中心偏移。
在一些实施方式中,进针450尖锐的锥形末端452终止于孔口454。在一个实施方式中,进针450具有螺纹近端456,下面将进一步描述其目的。
图35显示了一个实施方式的引导丝插入装置400的柔性闭孔器500。闭孔器500包括管502,近端螺帽504和远端塞子506。管502的大小可使它整齐地装配入空心进针450内且占据它的空腔长度。螺帽504可由紧固在进针450螺纹近端456上的螺纹金属路厄连接件构成。塞子506可由粘合剂如Loctite3104等形成。闭孔器500占据进针450的管腔,以最大程度地减少随着它推入患者,组织或其它物质进入进针450。
图36显示了第一引导丝插入装置400和第二引导丝插入装置400’,第一引导丝插入装置400连接于可啮合第一骨锚100的第一外接合件152,第二引导丝插入装置400’连接于可啮合第二骨锚340的第二外接合件152’。在一个实施方式中,手柄410和410’相对于外接合件152和152’枢转,以使进针450和450’前进通过患者的组织,分别向骨锚100和340的横向孔口116推进。图36还显示了一个实施方式的闭孔器500,将该闭孔器插入以上参照图35所示的引导丝插入装置400的进针450中。优选地,在进针450插入患者之前,将闭孔器500插入进针450并拧在其螺纹近端456上。类似地,可将另一种闭孔器500插入进针450’。
在本发明的一个实施方式中,引导丝插入装置400还包括引导丝套圈或接纳装置530,如图37所示。引导丝接纳装置530包括位于外管534内同轴线的内管532。内管532具有内半圆锥536,外管534具有外半圆锥538。内半圆锥536可卷起并收缩入外管534内。类似地,外半圆锥536可卷起以易于插入和通过空心进针450的管腔。内半圆锥536可相对于外半圆锥538旋转取向,以形成引导丝接纳装置530的锥形漏斗540,如图38所示。当引导丝接触引导丝接纳装置530的锥形漏斗540时,引导丝被导入内管532的管腔542内。引导丝接纳装置530还包括所示实施方式中的手柄544。
在图39中,将进针450推入通过骨锚100的横向孔口116,将进针450’推入通过骨锚340的横向孔口116。将引导丝接纳装置530插入通过进针450的管腔,展开其锥形漏斗540。将引导丝368插入通过进针450’的管腔并向引导丝接纳装置530的锥形漏斗540推进。当引导丝368接触锥形漏斗540时引导丝368被导入引导丝接纳装置530内管532的管腔542。
在图40中,将引导丝368推入通过内管532的管腔542,直到其延伸通过引导丝接纳装置530的手柄544。如上所述,本领域已知多种插入引导丝的方法,且本发明不限于本文所述方法。相反,本领域技术人员已知的任何插入引导丝的方法可用于本发明。放置引导丝368之后,除去第一插入装置400和第二插入装置400’。
在修饰的实施方式中,只使用第一引导丝插入装置400,将引导丝368插入通过第一骨锚100。然后,在插入装置400的帮助下或没有插入装置400的帮助,使用常规技术将引导丝368推过后续的骨锚和组织。
可沿引导丝368推入柔性或弯曲的骨钻孔器(未示出),以在骨锚100和340的横向孔口间形成通道。在一个实施方式中,带有钻头的骨钻臂具有某种程度的柔性,使其沿引导丝368的精确、不连续和/或非直线路径通过。在骨锚100和340的横向孔口116间形成通道后,从引导丝368除去骨钻。
在图41中,连杆200及其插入工具250被示为设置在引导丝368上。参考图3-3A以上描述了连杆200和插入工具250。在图41所示实施方式中的连杆200和插入工具250的分级特征略大于参照图3-3A所述的连杆和插入工具。再参考图41,连杆200的六角形近端202上具有一个或多个凸起220。凸起220与插入工具250远端处的一个或多个孔280互补。在图34中,连杆200与插入工具250分离。以上参照图5和5A叙述了连杆200与插入工具250的连接。
在图41中,使用插入工具250在引导丝368上将连杆200向骨锚100和340推进。虽然在所示实施方式中,连杆200由喙或骶途径(尾到头)插入,在其它实施方式中它也可由尾途径(头到尾)插入。
在图42中,将连杆200插入通过骨锚100和340内的各个横向孔口116。如上所述,连杆具有一个或两个关节208。关节208使连杆200具有一定程度的灵活性。这样,即使诸横向孔口116不对齐,连杆200可跟踪由引导丝368形成的非直线、弯曲或不连贯途径上并在诸横向孔口116间延伸。
如图43-44所示,可使用用驱动件150的内接合件154将锁帽106锁紧在骨锚340内,将连杆200固定在骨锚340内并固定关节208和/或连接件104的角度关系,如参照图2-3A所示。驱动件150的外接合件152啮合骨锚340头部,以防止其随着锁帽的锁紧而旋转。骨锚340和驱动件150之间的啮合如上文参考图1-2A的骨锚100的内容中所述。
在图45中,将驱动件150(包括外接合件152和内接合件154)从骨锚340中移去。以类似的方法将锁帽106锁紧在骨锚100中,将连杆200固定在骨锚100内。
在图46中,插入工具250与连杆200分离。连杆200与插入工具250的结合和脱离如参照图5和5A所述。然后,将驱动件150、护套320和引导丝368从患者中取出。这样,图46显示了由上述过程得到的经皮组装在适当位置的假体,包括骨锚100,340和连杆200。
图47显示了一种三级假体,它包括插入附加的相邻椎体中的附加的骨锚和图4-4B的连杆,以提供三级脊柱融合。
在一个实施方式中,近端骨锚的横向孔口116包括具有第一直径的近端孔口和具有第二较小直径的远端孔口。近端区段230的外径的尺寸对应于横向孔口116,使其可通过横向孔口116上的近端孔口但不能向远端通过横向孔口116的远端孔口。在这种方式中,一旦近端区段230向远端进入头部108内的位置时,临床医生可感觉到触觉反馈。这种结构也可应用于远端骨锚,以限制第一区段向远端推进通过横向孔口116。在修饰的实施方式中,第一和近端区段204,230的外径可逐渐变细,以达到上述结果。
并非所有上述步骤对最小侵入性地植入后固定硬件都是关键的。因此,可省略一些所述步骤或以另一种顺序实施这些步骤。而且,不背离本发明的范围,参考本说明书,本领域技术人员还可考虑其它步骤。此外,根据特点应用,可容易地改变上文提及的具体尺寸和角度,如本领域技术人员参考本说明将明白的那样。
在上述说明中,本发明包括多种结构和方法部分的互换和重组。例如,采用本文结合在此供参考的待批专利申请中所述方法,可通过相邻骨锚的横向孔口放置引导丝。或者,可将套管在引导丝上前进并通过骨锚100上的横向孔口,然后除去引导丝。接着,将连杆200推入通过套管。
上述各种材料、方法和技术提供了实施本发明的多种方式。当然,应理解,不要求本文所述的任何具体实施方式必须实现所有目的和优点。因此,例如,本领域技术人员将发现,可以实现或最优化本文所述一个优点或一组优点而无须实现本文提及或描述的其它目的或优点的方式,制造所述系统零件并执行所述方法。
虽然以某些优选实施例的方式描述了本发明,但参考本说明书,包括尺寸、构型和材料变化的本发明其它实施方式对本领域技术人员将是显而易见的。此外,与本发明任一实施方式相关的所有特征可容易地适用于其它实施方式。在不同实施方式中,除非另有说明,用于描述相似特征的不同术语或标号并不意味着区别。因此,只是参照所附权利要求书描述了本发明,而不是将本发明局限于所述优选实施方式。
Claims (45)
1.一种可植入的固定杆,其包括:
具有近端和远端的第一区段;
具有近端和远端的第二区段;和
第一区段和第二区段之间的关节;
其中,关节可在第一状态和第二状态之间转换,第一状态中第一和第二区段相互之间可移动,第二状态中第一和第二区段相互之间固定。
2.如权利要求1所述的可植入的固定杆,其特征在于,所述关节响应外侧压力从第一状态转化为第二状态。
3.如权利要求1所述的可植入的固定杆,还包括第三区段,所述第三区段通过第二关节可移动地连接于第二区段。
4.如权利要求1所述的可植入的固定杆,其特征在于,在第二状态中,所述固定杆的静态压力约为120-200lbs。
5.如权利要求1所述的可植入的固定杆,其特征在于,在第二状态中,所述固定杆的静态压力约为30-100lbs。
6.如权利要求1所述的可植入的固定杆,其特征在于,所述关节的构型可使第一和第二区段纵轴线相互之间的角度最大调节至7.5度。
7.如权利要求1所述的可植入的固定杆,其特征在于,所述关节的构型使第一和第二区段纵轴线相互之间的角度最大调节至15度。
8.如权利要求1所述的可植入的固定杆,其特征在于,所述关节的构型使第一和第二区段纵轴线相互之间的角度最大调节至45度。
9.一种最小侵入性后固定假体组合装置,其包括:
连杆,所述连杆具有近端和远端、以及近端上的可拆的连接结构,所述连杆至少包括关节处连接在一起的第一区段和第二区段,所述关节被构造成可使所述第一和第二区段被定位在相互之间的多种角度取向处;和
具有孔口和锁件的骨锚,所述连杆的至少一部分可延伸通过所述孔口,所述锁件被构造成固定第一和第二区段间的角度取向。
10.如权利要求9所述的假体组合装置,其特征在于,所述连杆包括通过第二关节连接于第二区段的第三区段,所述关节被构造成可使所述第三区段和第二区段被定位在相互之间的多种角度取向处。
11.如权利要求10所述的假体组合装置,所述装置包括也具有孔口和锁件的第二骨锚,所述连杆的至少一部分可延伸通过所述孔口,所述锁件被构造成可靠地啮合所述连杆并固定第三区段和第二区段之间的角度取向。
12.如权利要求9所述的假体组合装置,其特征在于,所述骨锚包括头部,在所述头部中,形成所述孔口,所述锁件包括位于所述头部内的可旋转的连接件,所述可旋转的连接件适于可靠地啮合所述连杆并固定第一区段和第二区段之间的角度取向。
13.一种最小侵入性的后固定假体,其包括:
具有头部的骨锚;
沿垂直于所述骨锚中心轴线的轴线延伸通过所述头部的横向孔口;
延伸通过所述横向孔口的杆的第一区段,所述第一区段形成第一表面;
具有第二互补表面的杆的第二区段;
至少部分由所述第一表面和所述第二表面形成的关节;和
锁帽,所述锁帽响应侧向移动将所述第一区段固定在所述横向孔口内并固定所述关节的角度关系。
14.如权利要求13所述的假体,其特征在于,所述第一区段还包括至少一个压缩缝隙。
15.如权利要求13所述的假体,其特征在于,所述杆适合于可拆卸地固定于将所述杆插入所述横向孔口的插入工具。
16.如权利要求13所述的假体,其特征在于,还包括杆的第三区段,所述第三区段形成插口,所述插口用于接受定位在所述第二区段上的球。
17.如权利要求16所述的假体,还包括具有头部、横向孔口和锁帽的第二骨锚,所述锁帽响应侧向移动将所述第三区段固定在第二骨锚的横向孔口内并固定第三和第二区段间的角度关系。
18.如权利要求17所述的假体组合装置,其特征在于,所述第三区段可固定于插入工具,所述插入工具用于将所述杆插入所述骨锚的所述横向孔口。
19.一种治疗脊柱的方法,包括以下步骤:
将第一骨锚固定于第一椎体;
将第二骨锚固定于第二椎体;
将有关节的连接件放置在所述第一和第二骨锚之间;和
将连接件从柔性构型转化为刚性构型,以使第一骨锚固定于第二骨锚。
20.如权利要求19所述的治疗脊柱的方法,其特征在于,所述第一骨锚位于骶骨中,所述第二骨锚位于L5椎骨中。
21.如权利要求19所述的治疗脊柱的方法,其特征在于,所述固定第一骨锚的步骤包括使带螺纹的骨螺钉进入所述第一椎体内。
22.如权利要求19所述的治疗脊柱的方法,其特征在于,所述放置有关节的连接件的步骤包括将有关节的连接件推入通过至少一个第一和第二骨螺钉中的孔。
23.如权利要求22所述的治疗脊柱的方法,其特征在于,所述放置有关节的连接件的步骤包括将有关节的连接件推入通过每个第一和第二骨螺钉中的孔。
24.如权利要求19所述的治疗脊柱的方法,其特征在于,所述放置有关节的连接件的步骤包括将有关节的连接件经皮推进通过组织。
25.如权利要求19所述的治疗脊柱的方法,其特征在于,所述转化步骤包括将至少一个可枢转的关节锁定在连接件上。
26.如权利要求25所述的治疗脊柱的方法,其特征在于,所述转化步骤包括操纵骨锚上的一部分以转化连接件。
27.如权利要求26所述的治疗脊柱的方法,其特征在于,所述转化步骤包括旋转骨锚上的螺纹轴,以将压力施加于连接件。
28.一种最小侵入性的后固定方法,包括:
将骨锚固定于椎体,所述骨锚具有孔口和锁定装置;
沿通过所述孔口连接件的途径在引导丝上插入杆,所述杆具有在杆的第一区段和杆的第二区段之间的至少一个角度可调节的关节;和
调节所述锁定装置,以固定在所述第一区段和所述第二区段之间的角度位置。
29.如权利要求28所述的方法,还包括:
将第二骨锚固定于第二椎体,所述第二骨锚具有第二锁定装置;
将所述杆插入通过所述第二骨锚;和
固定所述第二锁定装置,以相对于所述第二骨锚固定所述杆并固定位于所述杆的第三区段和第二区段之间的第二角度可调节的关节。
30.如权利要求28所述的方法,其特征在于,所述第一椎体和所述第二椎体是相邻的椎体。
31.如权利要求28所述的方法,其特征在于,所述第一椎体和所述第二椎体被一个或多个其它椎体隔开。
32.一种植入脊柱融合硬件的方法,包括以下步骤:
将具有第一孔的第一骨锚放置在第一椎体中;
将具有第二孔的第二骨锚放置在第二椎体中;
推进引导丝通过所述第一和第二孔,形成非直线通路;和
沿着由引导丝形成的非直线通路推进具有至少一个角度可调节的关节的固定杆,并通过所述第一和第二孔。
33.如权利要求32所述的植入脊柱融合硬件的方法,其特征在于,所述第一和第二椎体是相邻的椎体。
34.如权利要求32所述的植入脊柱融合硬件的方法,其特征在于,所述第一和第二椎体被第三椎体隔开。
35.如权利要求32所述的植入脊柱融合硬件的方法,还包括将导管沿着引导丝推进并通过第一和第二孔的步骤。
36.如权利要求35所述的植入脊柱融合硬件的方法,还包括将固定装置推进通过导管的步骤。
37.一种植入脊柱融合硬件的方法,包括以下步骤:
将具有第一孔的第一骨锚放置在第一椎体中;
将具有第二孔的第二骨锚放置在第二椎体中;
将对准工具安装于至少一个骨锚,所述对准工具包括弯曲的导向针;
利用所述对准工具使引导丝通过第一和第二孔;和
将分段固定杆沿着引导丝推进并通过所述第一和第二孔。
38.如权利要求37所述的植入脊柱融合硬件的方法,其特征在于,在放置骨锚步骤之前,将对准工具的至少一部分安装于骨锚。
39.如权利要求37所述的植入脊柱融合硬件的方法,其特征在于,所述第一和第二椎体是相邻的椎体。
40.如权利要求37所述的植入脊柱融合硬件的方法,其特征在于,所述第一和第二椎体被第三椎体隔开。
41.如权利要求37所述的植入脊柱融合硬件的方法,其特征在于,所述安装对准工具的步骤包括将中心臂安装到骨锚上,所述中心臂可枢转地连接于径向臂,所述导向针装在所述径向臂上。
42.如权利要求41所述的植入脊柱融合硬件的方法,其特征在于,所述导向针的曲率半径约为6-15厘米。
43.如权利要求37所述的植入脊柱融合硬件的方法,还包括操纵骨锚的一部分以锁定固定杆的步骤。
44.如权利要求37所述的植入脊柱融合硬件的方法,还包括沿着引导丝推进导管并通过第一和第二孔的步骤。
45.如权利要求44所述的植入脊柱融合硬件的方法,还包括推进固定杆通过导管的步骤。
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- 2003-08-15 US US10/642,399 patent/US7083621B2/en not_active Expired - Fee Related
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Cited By (2)
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CN102599967A (zh) * | 2012-04-17 | 2012-07-25 | 上海市奉贤区中心医院 | 一种手术用骨折间接复位器 |
CN105662503A (zh) * | 2014-10-23 | 2016-06-15 | 德普伊新特斯产品公司 | 肱二头肌肌腱固定术植入物和递送工具 |
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