CN105163690B - 用于将植入物置入两个椎骨体之间的椎间盘间隙中的器械组和方法 - Google Patents

用于将植入物置入两个椎骨体之间的椎间盘间隙中的器械组和方法 Download PDF

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CN105163690B
CN105163690B CN201480025131.3A CN201480025131A CN105163690B CN 105163690 B CN105163690 B CN 105163690B CN 201480025131 A CN201480025131 A CN 201480025131A CN 105163690 B CN105163690 B CN 105163690B
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implant
apparatus group
sleeve
intervertebral disc
disc space
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CN105163690A (zh
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W.里斯
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Joimax GmbH
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Abstract

为了将植入物(Cage)插入两个椎骨体之间的椎间盘间隙,本发明提供一种器械组,其具有导丝、多个能套在导丝上并且能相互推套的扩张器、工作套筒和植入物,其中,工作套筒在其远身区域内设计成,使该工作套筒能够在其近身端部具有角移动性或可变化的角定向性的情况下使其远身区域在其延伸方向上固定。

Description

用于将植入物置入两个椎骨体之间的椎间盘间隙中的器械组 和方法
本发明涉及一种用于将植入物置入两个椎骨体之间的椎间盘间隙中的器械组,其具有导杆、多个能套在导杆上和可相互推套的扩张器、工作套筒和植入物,以及涉及一种用于将植入物置入两个椎骨体之间的椎间盘间隙中的方法,其中,首先置入针管,然后通过针管将导丝置入至椎间盘间隙中,移除针管,然后将分别具有更大直径的扩张器套上导丝依次并且相互推套,此外,工作套筒通过最后一个扩张器置入至椎骨体,将导丝以及扩张器从工作套筒中移除。
对于一系列脊柱损伤,尤其是椎间盘损伤,如椎间盘突出之后的椎滑脱和不稳定以及狭窄,在两个与损伤相关的椎骨体之间实施脊柱加固。为此,将(椎间)植入物(英语:Interbody Cage)置入椎骨体之间已清理的椎间盘间隙,椎骨体与植入物一同生长。这称作例如腰椎融合(腰椎椎间体融合-LIF)。针对胸脊和颈脊存在相似的方法。为此,一般实施皮肤切开,以便能够在可视的情况下深入椎间盘间隙,其中,这导致肌肉损坏。在此,附加地嵌入微创脊柱外科中的具有螺钉-杆-系统的经皮螺栓连接能有助于整体稳定。
已知的用于将植入物置入椎骨体之间的椎间盘间隙中的介入技术有许多缺点和危险。
本发明所要解决的技术问题是,提供一种用于将植入物置入椎间盘间隙中的器械组和方法,通过该器械组和方法可以以简单的方式、不复杂地并且以尽可能少的损伤病人的风险将植入物置入椎间盘间隙中。
该技术问题按本发明通过本文开头所述类型的器械组解决,该器械组的特征在于,工作套筒在其远身区域内设计成,使得它在其近身端部具有角移动可能性(或角移动能力)或可变的角定向可能性(或角定向能力)的情况下能够实现其远身区域在其延伸方向上的固定。基本上,按本发明的器械组的所有部件、尤其是进入身体的部件由金属、尤其是(不锈的)精炼刚制成。
因此本发明规定,器械组的工作套筒在进入工作位置即椎间盘间隙的路径扩宽之后,一方面可固定在该工作位置上并且这样在两个从上方和下方限定椎间盘间隙的椎骨体上存在支座且因此轴向地固定,另一方面其(尤其是其近身端部的)相对椎间盘间隙或相对限定椎间盘间隙的椎骨体或脊柱、尤其是相对其延伸方向的定向是可变的并且因此在一定范围内可移动。
在优选的设计方案中规定,工作套筒在其远身区域内是柔性的和/或工作套筒设计成楔形套筒。为此,可以优选规定,工作套筒在其远身端部区域内具有两个在留有凹处的情况下沿对角线相互对置的、轴平行地延伸的突起,其中,尤其是突起在其远身自由端部上分别设有倒圆角。
在首先提到的设计方案中,套筒在角度上的可调节性或可移动性实现的方式是,其远身端部区域是柔性的。这在第二提到的设计方案中通过以下方式实现,即,其远身端部具有所述轮廓,该轮廓能够在不同的角定向情况下实现在限定椎间盘间隙的椎骨体上的轴向固定。此外,该设计方案的其它优点是,椎间盘间隙也可以在清理椎间盘之后通过在相邻椎骨体之间的椎间盘间隙中突出的楔形突起保持敞开;那么椎骨由此保持了距离。
器械组的优选的设计方案还规定,植入物和用于置入植入物的插入器械分别具有相互共同作用的锁定元件,所述锁定元件形成共同的锁定结构,其中,尤其是插入器械和植入物的锁定结构允许这两个部分具有角度上的可移动性。
在扩展设计中可以规定,工作套筒在其远身的外周或外表面区域设有切缝,在切缝之间布置有肋条;切缝使工作套筒的远身端部区域在还具有足够刚性的同时具有弹性和柔性。切缝尤其围绕工作套筒的外周沿螺旋线、即螺旋状或螺旋线形地延伸。此外,按本发明的器械组的优选设计方案的特征在于,在螺旋线上,至少两个切缝通过隔片分隔开地前后相互对齐地布置,其中此外,切缝、肋条和隔片的宽度在0.5mm到2mm之间。
切缝尤其是从其近身端部螺旋线形地从左向右或以在从套筒近身端部观察时的顺时针方向延伸至其远身端部。由此,通过逆时针旋转较容易实现工作套筒的引入。最后,通过顺时针旋转来固定套筒,由此通过周围的肌肉纤维实现“对接”或固定。在工作期间,在此可以用内窥镜方式确定肌肉纤维和通过切缝进入套筒内部的神经以及出血。
在另一个设计方案中规定,在植入物的端面上设有作为锁定元件的具有比宽度更大的高度的开口,其中,开口在其宽度的方向上设有侧凹,其中,插入元件具有杆,该杆具有在远身端部上设计成锁定元件的、沿径向延伸的具有比高度更大的宽度的板,借助把手能使所述板围绕杆的轴线翻转或偏转。
工作套筒在远身区域内的柔性或可弯曲性原则上也可以以其它的方式实现,例如通过各两个或三个具有余下的肋条和隔片的圆周切缝在轴向方向上给定的顺序实现。螺旋状或螺纹形设计方案的优点是,工作套筒由此能更容易通过螺旋运动引入,为此,近身优选设置径向杆。
器械组的扩展设计规定,插入器械具有带近身把手套筒的管,杆延伸通过该管,使得板可相对管偏转优选不超过相对角度55°,并且支座构造在具有两个相互平行延伸的凸形的端面边棱的管上。
在按本发明的器械组的进一步优选的设计方案中规定,插入器械和植入物分别具有连续通道。由此,可以将插入器械和相连的植入物通过导丝或套在导丝上地推入椎间空间或椎间盘间隙。因此进一步地,插入器械可以在与置于椎间盘间隙中的植入物分离之后再通过导丝移除。
植入物优选设计具有网状或格栅状区域,尤其是具有金刚石晶格结构。在植入物外侧上的格栅状区域的每个开口的开口直径的数量级为500μm至700μm和/或在植入物内部的格栅状区域的开口或缺口的直径为1500μm至3200μm或统一的开口直径为500μm至3200μm。材料的壁厚在此优选在600μm,尤其是800μm的数量级上。
此外,按本发明的技术问题通过本文开头所述类型的方法解决,该方法的特征在于,推入构造在远身外周区域内的柔性的工作套筒中,使得在椎间盘从椎间盘间隙中移除之后通过工作套筒将具有至少部分多孔结构的植入物借助插入器械推入到椎间盘间隙中,通过该插入器械锁定植入物,然后松脱在植入物和插入器械之间的锁定装置,之后移除工作套筒。除了避免现有技术的其它缺点之外,在本发明的技术方案中尤其是无需小关节(Facettengelenk)-切除术。
在此尤其可以规定,将器械与棘突成大于45°且小于70°,优选大于55°且小于65°地经皮从背部引入至椎骨体,其中,还将器械从背部在横向突出部的远离背部表面的侧面引入到椎骨体上。
此外可以规定,工作套筒在其具有切缝和布置在切缝之间的隔片的远身外周区域内通过扩张器引入,其中,尤其是工作套筒借助螺旋延伸的切缝以螺旋运动方式通过扩张器引入和/或多孔设计的植入物通过该工作套筒引入椎间盘间隙中,其中,引入尤其是具有在内部更粗孔隙度以及在外部区域上更细孔隙度的植入物。
本发明的其它优点和特点由各权利要求和以下说明中获得,在本发明的实施例中参照附图详细地阐述。在此示出:
图la示出由两个椎骨构成的椎骨段的侧视图;
图lb示出椎骨的俯视图;
图lc示出具有置入的植入物(Cage)的椎骨的俯视图;
图2示出按本发明的设备的成套进入器械或各进入器械;
图3a、图3b示出两个具有不同直径的工作套筒;
图3c示出备选的楔形套筒形式的工作套筒的侧视图;
图3d示出图3c的楔形套筒从上看的轴线垂直的视图;
图4a示出形式为O-Cage的植入物的示意性立体图;
图4b示出图4a的O-Cage的示意性侧视图;
图4c示出形式为P-Cage的植入物的立体图;
图4d示出P-Cage的侧视图;
图5a示出插入器械和形式为O-Cage的植入物在设备之前的侧视图;
图5b示出剖切在引入位置中的插入器械得到的水平纵剖面;
图5c示出在与植入物的锁定位置中的插入器械的水平纵剖面;
图5d示出插入器械的近身部分的局部放大图;
图5e示出带有耦连的植入物的插入元件的远身区域图,用于说明在已锁定情况下沿垂直方向在插入器械和植入物之间的在角度上的可移动性;
图5f示出相应于图5d的改变的实施形式的纵剖面图;
图6a示出通过椎间孔放置到椎间盘间隙处的空心针管;
图6b示出带有通过其引入的导丝的空心针管;
图6c示出在移除空心针管之后的导丝;
图6d示出通过导丝引入的双插管化的导杆,其具有另一个直径更大的导丝;
图6e-图6i示出套上导杆的第一扩张器(导引套筒)(图6e)至第五扩张器(图6i);
图6j示出套上扩张器的工作套筒;
图6k示出在移除导杆和扩张器之后以柔性的远身端部区域固定在端面的椎骨体上的第一设计方案的工作套筒;
图6l示出在移除导杆和扩张器之后以其端面固定在椎骨体上的第二设计方案的楔形套筒形式的工作套筒;
图7a示出通过工作套筒引入的内窥镜,其具有通过工作套筒引入至椎骨体的可转动的用于移除椎骨体材料从而扩宽椎骨体之间空隙的铣刀;
图7b示出与椎骨段对接的工作套筒,其具有引入的内窥镜以及导引穿过内窥镜的工具,所述工具形式为两个不同的用于移除椎间盘组织的钳子;以及
图8a-图8c示出借助插入工具通过导丝将植入物置入椎骨体空隙的过程。
本发明涉及将植入物置入一般填充有椎间盘组织的处于椎骨段的两个椎骨体之间的空隙,即椎间盘间隙,以便代替椎间盘并且持久地稳定椎骨段,一般称作(腰)椎融合。
图la是由两个椎骨1.1和1.2以及它们之间的椎间盘间隙1.9构成的脊柱的椎骨段1的侧视图,在椎间盘间隙中具有椎间盘(未示出)。从图lb的俯视图中可见,椎骨1.1包括椎骨体1.2、从椎骨体1.2在形成椎管的椎孔1.3的侧面并且限定它地朝背部延伸的椎弓根1.4、接下来的椎骨弓臂1.5和(起始于椎骨弓臂并且通过椎骨弓臂连接的)中央的棘突1.6以及侧向以大致60°的角度延伸的横突1.7。在椎弓根1.4上构造有椎骨铰接面1.8.1和1.8.2,其中,椎骨的椎骨铰接面与相邻椎骨的椎骨铰接面共同作用。
在两个椎骨体1.1和1.2之间留有空隙,即椎间盘间隙1.9,在椎间盘间隙1.9中具有椎间盘(未示出)。在两个叠置的椎骨的椎弓根1.4之间构造有椎间孔1.10或椎骨间孔(Foramen Intervertebrale),该椎间孔1.10由上椎骨的椎下切迹1.10.1和下椎骨的椎上切迹1.10.2限定。
如以下还将示出的那样,本发明规定,进入椎骨体1.1和1.2之间的椎间盘间隙1.9的通路要通过椎间孔1.10或侧向地从椎间孔旁经过。
按本发明的用于将植入物(Cage)置入椎间盘间隙1.9的成套器械或器械组2在所示的实施例中首先具有下面在图2和图3a、图3b中所示的器械:空心针管2.0、侧向柔性的但轴向足够刚性的导丝2.1,用于通过尤其是以45°到70°之间,优选55°到65°之间的角度切入病人皮肤而侧向从椎间孔1.10旁经过地置入到椎间盘间隙1.9或直接地置入椎间盘间隙1.9(图6a)。
可以设置具有约1mm和约2mm的两个管腔的双插管化的导杆2.2a,用于必要时用更粗的导丝替换更细的导丝2.1。
此外,第一扩张器2.2设置为导引套筒或导引杆以及其它扩张器2.2-2.6(在具有导引套筒的所示实施例中有总共五个扩张器的),其中,根据待插入的植入物的大小使用三个、四个或所有五个扩张器。第一扩张器2.2的内径相当于导丝2.1的外径,第二扩张器2.3的内径相当于第一扩张器或导引套筒2.2的外径。其它扩张器2.4至2.6的内径分别相当于更小横截面的扩张器2.3至2.5的外径。必要时还可以设置更多的扩张器。扩张器的外径为8mm至25mm,其中,在所示的实施例中,扩张器2.5和2.6的外径为15mm或18mm。壁厚为0.5mm到2mm之间。
扩张器2.3至2.6基本上设计成柱体套或壳,但其壁在其远身端部上从外向内圆锥形变细。此外,具有相应更大直径的扩张器的长度小于具有更小直径的扩张器的长度,如从图2中可见。这样可以在之后简单地依次从内部分别移除扩张器。
进一步地,首先工作套筒3.1或3.2如在3a或图3b中所示的那样属于器械组2,其中,图3a的工作套筒3.1在直径比例上相当于图2的扩张器2.5,因此该工作套筒3.1可以套上扩张器2.4,而图3b的工作套筒3.2的内径相当于扩张器2.5的外径,因此前者可以套在后者上。
必要时三个或四个扩张器也是足够的,更小直径的工作套随后套上这些扩张器。对于工作套筒3.1,3.2,远身端部区域大致在工作套筒长度的四分之一至三分之一上设计成柔性的。这在图3a、图3b的实施方式中实现的方式是,在工作套筒3.1(或3.2)的柱体套3.3中设有完全贯穿壁的切缝3.4,在切缝3.4之间留有肋条3.5,其中,肋条3.5和切缝3.4螺纹形地(从近身端侧3.6观察顺时针地)导引。切缝3.4不是连续地在整个外周上延伸,而是在所示的实施例中仅在大致一半的外周上延伸并且通过隔片3.7中断,该隔片3.7连接两个相邻的隔片3.9。此外,工作套筒3.1,3.2的柱体套壁的远身端面3.8也通过隔片3.9封闭,因此切缝没有自由地延伸到近身端面3.6中。然而,工作套筒3.1,3.2的套壁3.3的远身端面设计成具有突起和凹处的波浪形。以此通过在两个椎骨体1.1、1.2的外侧上扩张的肌肉组织进行工作套筒的可靠固定,在椎骨体的椎间盘间隙1.9中应当插入植入物(图la、图lb)。器械组还可以包括内窥镜以及工作工具,如铣切器、骨膜剥离器或骨锉、钻机、锉刀和钳子,它们本身是已知的,但下面还要描述。在工作套筒3.1、3.2的近身端部3.6上设有径向杆3a,借助该径向杆可以容易地通过拧入将工作套筒套上扩张器。工作套筒3.1、3.2尤其是在O-Cages(O-植入物;见下文)中使用。
在图3c、图3d中示出楔形套筒形式的工作套筒3a的备选的第二设计方案。该楔形套筒在其远身端部上具有两个轴平行的突起3a.1,突起3a.1相互成对角线地对置并且在它们之间形成凹处3a.2。原则上,这种楔形套筒也可以在其远身端部区域内(相对突起3a.1近身地)与套筒3.1、3.2相应地设计为柔性,其中,柔性同样可以由切缝产生。楔形套筒优选用于置入P-Cage。
此外,属于按本发明的器械组的有至少一个植入物4以及插入器械5(尤其是图5a、图5b),该至少一个植入物4形式为O-Cage或Oblique-Cage(斜形植入物)(图4a、图4b)或者形式为P-Cage或Postorior-Cage(后部植入物)(图4c、图4d-植入物的资质说明引入方向或在病人身体上的插入点),该至少一个植入物4应当分别置入椎间盘间隙1.9中,借助插入器械5使植入物4通过工作套筒3.1或3.2置入椎间盘间隙1.9。
植入物4通过电子束熔炼(electron beam melting)由钛合金,尤其是TI6AL4V,按标准ISO5832-3制成,其中,构件在高真空中借助电子束通过金属粉末熔化而制成。由此,可以在不损失模具或型芯的情况下产生侧凹。
植入物4在结构上可以具有三个不同的区域:首先作为承载结构的实心部分4.1,然后在实心部分4.1的内部具有带粗蜂窝或格栅结构的芯,并且在四个纵向侧面的外部区域上同样具有蜂窝或格栅结构4.2。这些部分的格栅结构用于使骨材料能够向植入物4内生长,以便能够实现植入物和相邻的椎骨体1.1、1.2之间的固定连接。
植入物4的长度为22mm至35mm,优选形式为O-Cage的植入物的总长度为34mm,宽度的数量级在10mm到15mm之间,并且根据病人的身材和置入点或椎骨体和其椎间盘间隙(植入物应当置入该椎间盘间隙中)具有不同的高度,即在6mm至16mm之间,优选8mm、10mm、12mm或14mm。
以这种宽度和高度,具有最大高度的植入物可通过工作套筒3.2置入椎骨体1.1和1.2之间的椎间盘间隙1.9,其它植入物可通过工作套筒3.1置入椎骨体1.1和1.2之间的椎间盘间隙1.9。外部蜂窝或格栅结构的开口可以相等,数量级在0.5mm到3.2mm之间。备选地,可以在内部设置具有1.5mm至3.2mm的开口的更粗略的结构,而在外部设置具有0.5mm至0.7mm开口的更好的结构。
O-Cage(图4a、图4b)具有大于30mm,优选大致35mm的长度,并且以与棘突1.6(图lc)成约60°的角度引入椎间盘间隙(详细内容在下面进一步阐述)。P-Cages更短并且根据病人不同具有24mm到30mm的长度。P-Cages在背侧在棘突旁略微倾斜于其地引入椎间盘间隙中。
插入器械5首先具有把手5.1和(第一)外部管5.2,该外部管5.2通过中间部分5.1.1与把手5.1固定连接。杆或此处的(第二)内部管5.3延伸通过外部管5.2。
把手5具有轴向缺口5a,该轴向缺口与内部管5.3的空腔5.3a对齐。内部空腔5.3a通入远身开口5.3b。这样从缺口5.1a的近身端部到内部管5.3的远身端部形成连续的通道4.4(图5f)。
由此,同样具有连续通道的植入物4可以借助插入器械5经由横卧的导丝通过其导引地置入到锥间空间(椎间盘间隙)中。
锁定轮5.3.2通过锁定弓形夹5.3.1与内部管5.3的近身端部连接。锁定弓形夹5.3.1在内部管5.3的圆周上与它固定连接。锁定弓形夹5.3.1延伸通过中间部分5.1.1的径向缺口5.1.2,该径向缺口5.1.2允许杆5.3相对中间部分5.1.1并且因此也相对把手5.1和管5.2偏转90°。为此,缺口在角方向上延伸约90°。
在角端部位置上(即在具有横向锁舌5.3.3(图5c)的远身锁定元件的锁定位置中),缺口5.1.2轴平行地朝近身方向延伸,因此在该位置中,内部管5.3与锁定轮5.3.2可共同地相对于把手5.1和管5.2朝近身方向移动。进一步,直接在锁定轮5.3.2的远身侧,在中间部分5.2.1上设有闭锁轮5.4,该锁定轮5.4通过螺纹连接5.4.1与中间部分5.1.2连接。
近身锁定件进一步在图5d中示出。其在插入元件上的布置与图5b和图5c相关地可见。
图5d放大地示出与把手5.1连接的中间部分5.1.1和在中间部分5.1.1内的(一侧的)径向缺口5.1.2,该径向缺口5.1.2具有角延伸的区段5.1.2.1和轴向延伸的区段5.1.2.2。在内部管5.3的近身端部上,侧面地具有两个彼此成对角线地对置的削平部5.3.5。锁定弓形夹轴向固定且抗扭地作用在该削平部5.3.5上,该锁定弓形夹具有两个平行地径向延伸通过缺口5.1.2的榫舌5.3.1.1。在此榫舌可以在角度方面运动到缺口的区段5.1.2.1中或轴向地运动到缺口的区段5.1.2.2中。在角度方面的运动在闭锁轮5.4的解锁位置中通过锁定轮5.3.2的侧向作用进行(图5b、图图5c),而锁定弓形夹的轴向运动在锁定弓形夹的外部弓形夹弓5.2.1.2上通过闭锁轮5.4本身实现(图5c),如前面所述。
在内部管5.3的远身端部上,该内部管5.3设有锤状的锁定元件,该锁定元件包括横向延伸的具有不同高度和宽度的远身横向锁舌5.3.3-分别垂直于内部管5.3的延伸方向。横向锁舌5.3.3为此具有径向突出内部管5.3的径向凸缘5.3.4。在外部管5.2的远身端部上设有支座5.2.1,该支座5.2.1具有平行的凹形构造的(垂直的)端面边棱5.2.2。
植入物4在端面上具有侧凹的开口4.5,其开口横截面相应于插入器械5的横向锁舌5.3.3的横截面。侧凹部由此形成,即,在侧壁4.6的近身区域内的内侧上设计有圆形凹处4.7。横向凸缘5.3.4在锁定器械5与植入物4的锁定位置中啮合到圆形凹处中。侧凹的开口4.5在植入物4上形成锁定元件,由此能够实现插入元件5和植入物4的锁定。
为了将插入器械5与植入物4连接,闭锁轮5.4在中间部分5.1.1上通过螺纹连接装置5.4.1朝远身方向转动(在一般的螺纹中并且从把手5.1观察以顺时针进行)。由此,释放锁定轮5.3.2并且通过锁定轮释放锁定弓形夹5.3.1,因此它可以从缺口5.1.2的轴平行的端部区域之一进入其角区域。
由此,可以将插入器械5的横向锁舌5.3.3在垂直定向(图5a、图5b)的情况下引入植入物4的开口4.1中,其中,横向锁舌5.3.3和开口4.5的最大尺寸的延伸方向一致。在横向锁舌5.3.3通过植入物的开口4.5引入之后,横向锁舌5.3.3偏转90°。为此,锁定轮5.3.2通过锁定弓形夹5.3.1并且通过锁定弓形夹使杆5.3和板5.3.3相对把手5.1偏转90°到横向锁舌5.3.3的锁定位置中,因此横向锁舌啮合到凹处4.5中并且因此与开口4.5后方的侧凹咬合(图5a)。然后,闭锁轮5.4(逆时针地)通过螺纹连接装置5.4.1相对把手5.1旋拧。由此,锁定弓形夹5.3.1近身压入缺口5.2.1的轴平行的区域之一中并且因此将横向锁舌5.3.3拉到形成侧凹的、植入物4的近身端壁区域上并且将植入物4拉到插入器械5的支座5.2.1上并且因此拉紧。拉紧的强度可以在此以期望的方式选择。尤其是由于支座5.2.1的端面的凹形设计,植入物4和插入件5可以相对偏转不超过约15°,如这在图5d中所示。由于插入口4.5延伸至植入物4的上壁4.8的区域,还可以扩大偏转角度,优选扩大至约35°(图5e)。松脱插入元件5和植入物4以相应的方式进行;前述步骤基本上以相反的顺序执行。插入器械5和所选的植入物4以上面参考图5a至图5d描述的方式相互连接。植入物4随即与插入器械5相连地通过工作套筒3.1、3.2(优选在X射线检查的情况下)引入椎间盘间隙1.9中。
植入物4根据下列方法引入椎间盘间隙1.9内:
病人优选稳稳地侧躺(俯卧也是可行的)并且通过麻醉在手术期间可持续交谈(它不需要全身麻醉,其中,全身麻醉也是可行的)。手术医生从脊柱侧面(棘突旁边约8-18cm)切入背部皮肤,然后以55°到65°之间,优选约60°的角度穿过切口,手术医生首先将空心针管2.0直接地沿横突远离背部的一侧放置到椎间盘间隙1.9中(图6a)。在此未影响到神经导引通过的椎管1.3。
通过该针管2.0,引入导丝2.1(图6b)。取出针管2.0并且保留导丝(图6c)。通过导丝2.1引入具有两个偏心钻孔的双插管化的导杆2.2a(图6d)。借助该导杆2.2a可以置入另一根具有更大刚性和必要时具有更大直径的导丝2.1a。取出导杆2.2a和第一导丝2.1,并且保留第二导丝2.1a。然后,通过(第二)导丝2.1a将第一扩张器2.2通过椎间孔推至椎间盘间隙1.9。然后移除(可能存在的第二)导丝2.1或2.1a,并且第一扩张器2.2用作用于其它扩张器2.3至2.5(或2.6)的导引套筒。然后,分别依次通过先前引入的扩张器推套其它扩张器2.3、2.4、2.5和可能存在的2.6(图6e至图6f)。
然后,通过最后一个扩张器(2.5或2.6)将工作套筒3、3.2之一推入至椎骨体1.1、1.2的外侧并且在该处以远身波浪形端面3.6固定(图6g)。然后,扩张器2.2-2.5(或者也可能是2.6)从工作套筒3或3.2中又沿近身方向拉出,因此仅保留工作套筒(图6h)。以相同的方式,原则上也可以通过扩张器2.2至2.5(2.6)引入第二设计方案(楔形套筒)的工作套筒3a,其端部位置在图6i中示出。在此,相邻椎骨之间的突起3a.1啮合到椎间盘间隙中并且椎骨在此保持有距离。
现在可以通过工作套筒引入内窥镜6(图7a)并且通过该工作套筒引入在内窥镜观察方面适合的工具,如首先是铣切器7。借助铣切器,可以通过工作套筒3移除椎间盘材料和在椎骨体1.1、1.2的周边的骨组织。借助铣切器、钻孔器、骨膜剥离器或骨锉、钳子或通过刮刀片,为植入物4(O-Cage或P-Cage)配合精确地设置椎间盘间隙1.9。
然后,铣切器7又从内窥镜6移除并且通过内窥镜6可以引入其它器械,尤其是钳子8、9,以便将椎间盘的材料从椎间盘间隙1.9中移除,见图7b。
椎骨体可以在此以适合的方式保持距离,如通过椎弓根螺钉、楔形套筒等(这不是本发明的主题)。
在从椎间盘间隙1.9中移除椎间盘材料之后,内窥镜6和工具8、9从工作套筒3中移除。然后,借助插入器械5通过工作套筒3将植入物4引入椎间盘间隙,如这在图8a–图8c中所示。植入物4置入椎间盘间隙1.9的过程在X射线观察的情况下进行,其中,植入物4的材料(蜂窝结构的钛合金)能够实现良好地观察该置入过程。
当在图8a-图8c中示出将植入物4置入椎间盘间隙l.a(椎骨空隙)中的过程时,出于更好的直观性,不再示出与图6h或图6d相应地连接的工作套筒。
只要导丝2.1或2.1a被移除并且在借助通过内窥镜6工作的工具(图7a、b)移除椎间盘时未损坏,则在内窥镜6移除之前通过它重新引入导丝2.1或2.1a,然后移除内窥镜。于是,在病人身体内按图8a存在导丝,例如导丝2.1和工作套筒(出于上述原因未示出)。然后,与插入工具5以上述方式连接的植入物4借助插入器械5通过导丝2.1和通过工作套筒推入椎间盘间隙1.9中(图8b)。
当植入物4借助插入器械5置入椎间盘间隙1.9并且适当定位在椎间盘间隙1.9中之后,借助闭锁轮5.4解开锁定并且借助锁定轮5.3.2使板5.3.3回转(图5b、图5c),由此,插入元件5与植入物4分离并且插入元件5又可以通过工作套筒3在近身方向上与工作套筒3或导丝2.1分离。
然后在此位置中也通过内窥镜6直接地控制并且检查该植入物4。通过内窥镜的可视化控制或检查也可以通过可视的凹处(侧凹)附加地以骨(骨替代物)填充植入物4。最后还移除导丝2.1和工作套筒3,而植入物4留在椎间盘间隙1.9中。然后移除工作套筒3,缝合并且照料伤口,从而结束手术。
在外科手术的范围内,两个限定椎间盘间隙的椎骨还可以借助螺钉-杆-系统、椎弓根螺钉等拉紧或绷紧。这不是本发明的主题并且因此未示出也未描述。

Claims (17)

1.一种用于将植入物置入两个椎骨体之间的椎间盘间隙中的器械组,具有导丝(2.1)、多个能套在导丝上并且能相互推套的扩张器(2.3-2.6)、工作套筒(3)和植入物(4),其特征在于,所述工作套筒(3)只在其远身区域内柔性地设计,使得所述工作套筒能够在其近身端部具有角移动性或可变化的角定向性的情况下使其远身区域在其延伸方向上固定,其中,所述工作套筒在其远身外周区域内设有切缝(3.4),在所述切缝(3.4)之间布置有肋条(3.5)。
2.按权利要求1所述的器械组,其特征在于,所述切缝(3.4)围绕所述工作套筒(3)的外周(3.3)螺旋线形地延伸。
3.按权利要求2所述的器械组,其特征在于,在螺旋线上,至少两个切缝通过隔片(3.6)分隔开地前后相互对齐地布置。
4.按权利要求1所述的器械组,其特征在于,切缝(3.4)、肋条(3.5)和隔片(3.6)的宽度在0.5mm到2mm之间。
5.按权利要求1所述的器械组,其特征在于,所述工作套筒这样设计成楔形套筒(3a),使得所述楔形套筒在其远身端部区域内具有两个在留出凹处(3a.2)的情况下沿对角线相互对置的、轴平行地延伸的突起(3a.1)。
6.按权利要求5所述的器械组,其特征在于,所述突起在其远身自由端部处分别设有倒圆角。
7.按权利要求1所述的器械组,其特征在于,所述植入物(4)和用于置入所述植入物(4)的插入器械(5)分别具有相互共同作用的锁定元件(4.1、4.2;5.5、5.7),所述锁定元件形成共同的锁定结构。
8.按权利要求7所述的器械组,其特征在于,插入器械(5)和植入物(4)的锁定结构允许这两个部分(5、4)具有角移动性。
9.按权利要求1所述的器械组,其特征在于,所述植入物(4)在端面上具有作为锁定元件的高度大于宽度的开口(4.1),其中,所述开口(4.1)在其宽度方向上设有侧凹(4.2)。
10.按权利要求7所述的器械组,其特征在于,插入器械(5)具有杆或内部管(5.3),所述杆或内部管(5.3)具有在远身端部处设计成锁定元件的、沿径向延伸的宽度大于高度的板,借助把手(5.4)能使所述板围绕所述杆(5.3)的轴线翻转。
11.按权利要求10所述的器械组,其特征在于,所述插入器械(5)具有外部管(5.1),所述杆(5.3)延伸通过所述外部管(5.1),使得所述板(5.5)能够相对管(5.1)偏转并且能够通过把手套筒(5.2)锁定。
12.按权利要求11所述的器械组,其特征在于,在所述管(5.1)上设有支座(5.6),所述支座(5.6)具有两个相互平行延伸的凸形的端面边棱(5.7)。
13.按权利要求7所述的器械组,其特征在于,插入器械(5)和植入物(4)分别具有连续的通道。
14.按权利要求1所述的器械组,其特征在于,所述植入物(4)设计具有网状或格栅状区域(4.2、4.3)。
15.按权利要求14所述的器械组,其特征在于,所述格栅状区域(4.3)的每个开口的开口直径为0.5mm至3.2mm。
16.按权利要求4所述的器械组,其特征在于,切缝(3.4)、肋条(3.5)和隔片(3.6)的宽度在0.8到1.2mm之间。
17.按权利要求15所述的器械组,其特征在于,在所述植入物的外侧上的每个开口的开口直径在0.5mm至0.7mm的数量级上和/或在植入物内部的格栅状区域的开口或穿孔的直径为1.5mm至3.2mm。
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DE102013004964A1 (de) 2014-09-25
ES2723905T3 (es) 2019-09-03
US10342677B2 (en) 2019-07-09
WO2014146797A1 (de) 2014-09-25
EP2976046B1 (de) 2019-03-13
EP2976046A1 (de) 2016-01-27
KR20150133719A (ko) 2015-11-30
DE202013007361U1 (de) 2014-03-24
KR102292185B1 (ko) 2021-08-24
CN105163690A (zh) 2015-12-16
JP2016514503A (ja) 2016-05-23
DE102013004964B4 (de) 2016-11-03
JP6524538B2 (ja) 2019-06-05

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