CN101352367B - 骨固定装置 - Google Patents

骨固定装置 Download PDF

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CN101352367B
CN101352367B CN200810134158.2A CN200810134158A CN101352367B CN 101352367 B CN101352367 B CN 101352367B CN 200810134158 A CN200810134158 A CN 200810134158A CN 101352367 B CN101352367 B CN 101352367B
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bone
bone screw
thread portion
hole
screw
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CN101352367A (zh
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L·比德尔曼
W·马蒂斯
O·施瓦岑巴赫
M·帕布斯特
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Biedermann Technologies GmbH and Co KG
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    • A61F2/00—Filters 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
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Abstract

一种用于骨的固定装置(100)，该固定装置包括元件(1)，该元件将被固定到一个或多个骨(40，42)并且具有用于接收骨螺钉(30)的至少一个孔(2a-2c，2′，2″)，其中所述至少一个孔包括第一内螺纹部分(22a-22c，22′)。穿过所述孔插入骨中的骨螺钉具有：设有第一外螺纹部分(32)的第一锚杆部分，所述第一外螺纹部分布置成与所述至少一个孔的内螺纹部分配合；和头部(36)，其直径大于所述锚杆部分的直径以提供锁扣部，该锁扣部布置成与形成于所述孔中的止动部接合。所述骨螺钉进一步具有第二锚杆部分，该第二锚杆部分包括在所述头部的锁扣部和第一锚杆部分的外螺纹(32)之间延伸的间隙槽(34a)。所述间隙槽允许两个螺纹部分脱离啮合，使得当骨螺钉在相邻骨例如椎体内松动时防止骨螺钉被旋出所述孔。所述元件可以包括用在椎间植入装置中的支架的侧壁(4)，或者可以代表骨板组件的板。

Description

骨固定装置
技术领域
本发明涉及一种用于在人体的骨之间提供刚性或挠性连接的固定装置。本发明特别涉及一种椎间植入装置，该椎间植入装置包括装置主体，该装置主体具有分别用于与上和下椎体的终板接合的上表面和下表面、侧壁以及至少一个孔，所述孔形成于所述侧壁中用于接收作为固定元件将插入椎体中的骨螺钉。
背景技术
骨螺钉典型地具有锚杆部分和头部，所述锚杆部分具有布置成将锚固在相邻椎体中的外螺纹部分，所述头部的直径大于锚杆部分的直径以提供锁扣部，该锁扣部布置成与形成于装置主体的孔中的止动部接合。
文献US 2006/0085071 A1公开了一种包括主体的椎间植入装置，所述主体具有上侧面、下侧面以及前表面，适于容纳相应的骨螺钉的四个钻孔形成于所述前表面中。所述主体可以由身体相容塑料材料形成。为了向装置提供刚度和强度，由金属材料例如钛或钛合金制成的小前板附连到前表面。位置与塑料主体的相应钻孔对应的四个钻孔形成于前板中。骨螺钉均可以穿过前板的钻孔插入，然后还延伸穿过塑料主体的钻孔。
前板的钻孔设有内螺纹。这些内螺纹对应于设在骨螺钉的相应头部上的外螺纹。为了能够固定和压缩，带螺纹的头部成形为圆锥形，由此朝着骨螺纹的锚杆部分渐缩。
关于这样的构造，可能产生的问题是螺钉会松动并且通过施加作用于椎体上的外力会慢慢地被旋出，这会导致例如相邻血管的严重损伤和整个植入物的松动。为此，US 2006/0085071 A1进一步提出将固定板附连到前板。固定板覆盖前板中的钻孔的相应开口，从而固定插入其中的骨螺钉。结果，骨螺钉不能被旋出或掉落。
用于实现上述椎间植入装置的部件的数量增加并且装置的尺寸会不利地变大。进一步地，外科医生必须施加额外的旋拧步骤以便固定螺钉防止掉落。
文献EP 1 280 481 A1说明了一种包括支架(cage)的躯体内植入装置，所述支架由侧壁组成。然而，并未说明设在支架侧壁中的钻孔或孔用于容纳待插入其中的骨螺钉。
发明内容
因此一个目的是提供一种改进的椎间植入装置，该装置简化了将装置插入两个椎体之间的操作，当装置安装好时该装置增强了其抵抗外力的稳定性，该装置所使用的部件被有效小型化和/或该装置保护骨螺钉在松动的情况下不会被旋出或掉落。
所述目的由一种固定装置实现。
本固定装置布置用于提供一种机构，即使作为固定元件的骨螺钉松动，该机构也可以将骨螺钉固定就位，所述骨螺钉将插入相邻骨例如椎体中。为此，骨螺钉的锚杆具有两个部分：设有外螺纹部分的一个部分和设有间隙槽的另一个部分。
外螺纹部分可以与设在装置主体中的孔的内螺纹部分啮合。包括间隙部分的锚杆部分在骨螺钉的头部和包括外螺纹部分的锚杆部分之间延伸。
因此，首先可以使用骨螺钉的外螺纹部分将骨螺钉拧入孔的内螺纹部分中。然后当进一步拧入骨螺钉时，由于间隙槽的原因，一旦装置主体的孔中的内螺纹沿纵向方向的整个长度与间隙槽相对，外螺纹部分则与内螺纹部分脱离啮合。
然而，进一步可以使固定元件继续旋转例如大约90至大约270度的角度，以便使骨螺钉的外螺纹的螺纹尾部相对于孔的内螺纹部分的螺纹入口的定向独立。因此，即使固定在骨例如椎体中的骨螺钉随着时间松动，在螺纹尾部位置处的外螺纹的螺旋突起由于例如90-270度的错定向而邻接围绕孔的开口的端面。因此，装置主体迫使骨螺钉分别在骨内或在该例子中的椎体内被保持就位。
根据本发明的可供选择的但是类似的方面，骨螺钉在头部设有第二外螺纹部分。该第二螺纹部分与内螺纹部分配合，而第一外螺纹部分(即骨螺纹)与骨材料配合。圆柱形导引部分与内螺纹部分相邻地形成于孔内，以便当第二螺纹与孔中的内螺纹部分脱离啮合时接收头部。
在第二螺纹的螺纹尾部处的螺旋突起的邻接原理与第一方面中的相同。即在螺纹尾部相对于内螺纹部分的螺纹入口错定向例如90-270度的情况下，在与第二外螺纹部分脱离啮合之后，突出部抵靠在孔内部的相应端面上。因此，可以获得与第一方面中相同程度的防止骨螺钉掉落的保护。
应当注意的是，这里提出的固定装置包括待固定到一个或多个相邻骨的元件以及作为固定元件的骨螺钉。在一个实施例中，该元件可以实施为用于连接相邻椎体的支架。
然而，所述装置并不限于关于借助于这样的支架替换椎间盘的应用。相反地根据其它实施例，所述元件可以取决于应用具有板状、套筒状或任何其它合适的形状，以便固定或稳定脊柱的骨和其余骨骼的其它区域。
提供了其它几种固定装置，所述固定装置包括使用骨螺钉固定颈椎的板或侧向固定胸腰椎的板。还可以实施所有其它类型的板组件。
附图说明
通过参考结合附图的以下详细描述本固定装置的进一步特征和优点将变得显而易见并且将更好地理解。
图1示出根据第一实施例的椎间植入装置的透视分解图；
图2示出根据图1的装置的平面图；
图3A和3B示出根据图1的装置插入两个椎体之间的过程的示意图；
图4以三个截面图示意性地示出根据第二实施例将具有间隙槽的固定元件插入装置主体中的步骤；
图5与图4相同，但是具有根据第三实施例的直径增加的间隙槽；
图6与图4相同，但是相对于图1-3中所示的实施例；
图7A示出根据第一实施例正被插入孔中的固定元件的局部放大透视分解图，其中获得了在锁定之前的压缩状态；
图7B示出处于图7A中所示状态的固定元件的外螺纹的螺纹尾部和装置主体的孔的内螺纹的螺纹入口的相对定向的示意图；
图8A与图7A相同，但是处于锁定之后的状态，即进一步旋转90-270度；
图8B与图7B相同，但是由图8A的状态中所示的锁定旋转产生螺纹尾部相对于螺纹入口的相应错定向；
图9示出本发明的可供选择的实施例的示意图。
具体实施方式
图1以透视分解图示出根据本发明第一实施例的固定装置，在该实例中所述固定装置是椎间植入装置100。图2示出装置100的平面图。装置100包括装置主体1，该装置主体具有支架的形式。支架由生物相容材料例如钛、钛合金或PEEK(聚醚醚酮)制成并且设有封闭一个或多个内部中空空间的基本垂直的侧壁。所述空间通向支架1的上和下表面3a、3b。
支架1的侧壁由前壁4、后壁5、右侧壁6和左侧壁7组成，所述壁一体地形成，使得右和左侧壁与前和后壁彼此连接。前壁4表示支架1的前部壁，而后壁5表示支架1的后部壁。
支架1的刚性进一步由两个内壁8、9稳定，所述内壁8、9从后壁5朝着前壁4以弧形延伸。两个内壁关于矢状平面(sagittal plane)S对称。
进一步具有两个内壁10、11，所述内壁10、11从后壁分别朝着右和左侧壁6、7以弧形延伸。类似于内壁8、9，两个壁10、11关于矢状平面对称。壁8-11均具有朝着矢状平面凹入的弧形形状，而左和右侧壁6、7相对于矢状平面凸出。已发现侧壁和内壁的这种布置在支架-骨接合处提供最佳的载荷传递。
由侧壁和内壁限定的五个空间设计成填充有骨移植材料。进一步地，小齿16设在每个壁的上和下边缘上，即在支架1的上和下表面上，以便于两个表面嵌入相邻椎体40、42的终板中。一系列小齿的形状正好对应于壁的形状并且进一步被优化以在解剖学上适合相邻的椎体，即良好的应力分布和扭转稳定性。
支架1还设有各自用于接收或容纳骨螺钉的三个孔2a、2b、2c。孔2a-2c位于支架1的前壁4上，其中一个中心孔2b向下倾斜并且两个侧孔2a、2c向上倾斜。也可以布置成相反的情况，即中心孔2b向上倾斜并且两个侧孔2a、2c向下倾斜。如从图2的俯视图中可以看出的，孔2a、2c各自分别具有通向支架1的上表面3a的开口18a、18c。由于内壁8-11的特定形状和布置，三个孔的每一个还(以相对于横向平面的相应倾斜度)通向其自身的、由这些壁8-11限定的不同内部空间。
对于当前用于替换椎间盘的支架的应用，典型地可以布置45°±20°的倾角。在应用于固定板的情况下典型地将利用大约90°±30°的倾角。然而，本发明不应当限制在上面指出的特定值或范围。
孔的开口22a和22c设在相应的端面20a、20c中，所述端面形成前壁4朝着支架1的内部空间倾斜的内表面部分。端面20a、20c基本垂直于孔2a-2c的相应纵向轴线定向。如下所述，所述端面形成朝着形成于骨螺钉30a-30c上的间隙槽的螺纹尾部突出部的邻接区域。
图3A和3B示出了支架1插入两个相邻椎体40、42之间。为此保持狭槽14设在支架1的两侧，即设在右侧壁6和左侧壁7内。保持狭槽14是细长的并且沿支架1的横向平面T延伸。该狭槽允许由便于支架1插入的保持器械接合。在该实施例中，支架1代表前腰椎体间融合支架(ALIF支架)，其中该支架将从前部方向被引入腰部脊柱的两个相邻椎骨之间，以便例如替换脊椎盘。
一旦支架1大致定位在椎体40、42之间，骨螺钉30a-30c插入相应的孔2a-2c中并且拧入椎体40、42的终板中(图3B)。为了解释目的，在图4的实施例4中示出孔2′和相应骨螺钉30′的简化构造。图中类似的附图标记表示相同或类似的部件。
根据该实施例的骨螺钉30′(首先参见图4的上部)基本由三个部分组成：头部36、限定骨螺纹的第一(螺纹)锚杆部分以及包括间隙槽34a的第二锚杆部分。第一锚杆部分具有外骨螺纹32，该外骨螺纹设计成钻入和切入椎体40、42的相邻终板的骨材料中。骨螺纹由螺旋凹槽39和螺旋突起38形成。
第二锚杆部分具有间隙槽34a，该间隙槽从外螺纹的螺纹尾部朝着头部36延伸。在该实施例中，第二锚杆部分具有的直径与螺纹部分32的底径(core diameter)31(即相对于外螺纹的螺旋凹槽测得的直径)基本相同。换句话说，间隙槽34a的直径小于形成螺纹32的螺旋突起38的直径(外径)。
首先将骨螺钉插入形成于前壁4中的孔2′中，所述孔2′具有内螺纹部分22和圆柱形导引部分52。圆柱形导引部分52布置成容纳骨螺钉的头部36，其中相应的直径基本相同以便提供合适的导引。而且，导引部分52的直径大于内螺纹部分22的直径，其中这两个部分之间的过渡部由圆锥形止动部(stop)50表示，当到达压缩状态时所述止动部50可以由形成于骨螺钉30′的头部36上的相应圆锥形锁扣部(catch)35接合(图4的下部)。
骨螺钉的外骨螺纹32和孔的内螺纹22适于彼此啮合。因此，骨螺纹可以旋拧通过内螺纹22(图4的中间部分)。间隙槽34的纵向长度与内螺纹22的纵向长度基本相同。更准确地说，间隙槽的该长度与止动部50和通向支架1的前壁4的端面20′的开口18′之间的距离基本相同。结果，当锁扣部35抵靠在止动部50上时螺纹部分22、32脱离啮合。
进一步的旋拧导致支架1压靠在椎体40、42的终板上。然而，进一步的旋拧还导致在螺纹尾部处的螺旋突起37相对于内螺纹22的螺纹入口54(即进入开口18′的内螺纹的凹槽)错定向(misorientation)。因此，当进一步旋拧(旋转骨螺钉30′)时，在螺纹尾部处的外螺纹32的螺旋突起37抵靠在端面20′上。
图5以类似的简化构造示出本发明的可供选择的实施例。相同的附图标记表示相同或类似的部件。在该实施例中，骨螺钉30″的头部36与前面的第二实施例相比显著缩短。在插入时稳定地导引骨螺纹方面产生的不足由间隙槽34b的特征补偿，在该实施例中所述间隙槽与螺纹部分32的底径31相比具有增加的厚度。
然而，由于螺纹部分32的螺旋突起，间隙槽34b的直径实际上小于外径，使得间隙槽可以穿过孔2″的内螺纹部分。由此，间隙槽34b紧密接触孔的内螺纹部分的相应突起(未详细示出)，以便对骨螺钉起到紧密导引作用。换句话说，内螺纹部分22同时用作导引部分52b。附图标记52a(图5的上部)仅仅表示缩短的头部36的基座。
图6示出骨螺钉机构相对于图1-3中所示的第一实施例的相应构造。相同附图标记表示与其它实施例中相同或相似的部件。示出以下步骤：插入59骨螺钉、旋拧60骨螺钉30a-30c穿过孔2a-2c的内螺纹部分以及进一步旋转61骨螺钉以锁定该骨螺钉，如上面参考图4具体所述。还示出了通过锁扣部35作用在头部36上和通过外螺纹部分作用在骨螺钉30a-30c的第一锚杆部分上的合力F1、F2(图6的下部)。
图7A、7B、8A和8B示出了锁定或固定根据第一实施例的椎间植入装置100的操作。在该特定实施例中，使用六角头骨螺钉并且应用六角扳手以旋拧图7A和8A所示的骨螺钉30c。图7A示出一种状态，在该状态中锁扣部35抵靠在止动部50上，并且间隙槽34c延伸穿过前壁4内的孔2c的整个内螺纹部分22c。因此，当进一步旋拧时开始压缩。
在进一步压缩的同时，进一步旋转61螺钉30c例如85度使在外螺纹部分32的螺纹尾部处的螺旋突起37相对于孔2c的开口22c中的螺纹入口54(由于图7和8是截面图所以在图7和8中不可见)错定向。在图7B和8B的示意图中示出该定向。当骨螺钉松动时，只要螺纹尾部未能会合孔2c的螺纹入口54，作用在骨螺钉30c上以将其旋出的任何力将导致突起37更加地抵靠在前壁的端面20c上。因此，用本实施例实现了固定功能。
图9示出一个可供选择的实施例。相同的附图标记表示与先前的实施例中所示相同或类似的部分和部件。一个区别在于骨螺钉缺少间隙槽。然而，通过为骨螺钉300，更具体地为骨螺钉300的头部36设置第二螺纹部分330，获得防止螺钉掉落的保护或固定机构。
形成于支架的前壁400(或当考虑骨固定板时板组件的板400)中的孔200包括第一内螺纹部分220和与该内螺纹部分相邻的圆柱形导引部分520。在该实施例中，骨螺钉300的第二外螺纹部分330与头部的内螺纹部分配合，而第一螺纹部分(骨螺纹)32仅仅与相邻骨的骨材料配合。
为此，用于接收骨螺钉的锚杆部分的窄开口180不设有螺纹。
固定机构如下：在将骨螺钉插入支架的前壁400或板的孔200中之后，旋拧第二螺纹部分(头部螺纹)330穿过孔200的内螺纹220。由于头部螺纹的螺纹长度L1与圆柱形导引部分520的长度相同，所以当锁扣部35抵靠在止动部50上时，外螺纹330刚好离开或脱离内螺纹220。
由于导引部分520的圆柱形对称性，骨螺钉现在可在孔内自由旋转。因此，当骨螺纹被进一步更深地拧入相邻骨材料中例如80或90度至270或280度时，实现了锁扣部进一步压靠在止动部上。在头部螺纹330的螺纹尾部处的螺旋突起37由此相对于孔200内的内螺纹220的螺纹入口被错定向。因此，突起37在内螺纹220和圆柱形导引部分520之间的过渡部处抵靠在孔内的相应端面201上。
因此，螺钉不容易从支架或板掉落，即使螺钉在骨材料中松动。相反地，头部将牢固地保持在圆柱形导引部分520内。
应当理解的是，本发明不应当由如这里所述的具体特征限制。相反地，在本发明的范围内对上述实施例应用各种修改。例如骨螺钉可以通过本领域中公知的除了六角头螺钉以外的机构和工具拧入骨材料中。另外，作为例子，可以根据特定需要选择用于支架和螺钉的材料。
更进一步地，尽管利用三个孔容纳三个骨螺钉的实施例已被发现并且被描述成提供关于应力和扭矩分布的优化设计，但是还可以利用两个、四个或更多孔和骨螺钉的其它设计。另外，本发明并不局限于如本实施例中所示的支架的内和外侧壁的特定布置。特别地，本发明包含关于骨板或类似骨固定装置的应用。

Claims (1)

1.一种用于骨的固定装置(100)，该固定装置包括：
元件(400)，其将固定到一个或多个骨并且具有用于接收骨螺钉(300)的至少一个孔(200)，其中至少一个孔(200)包括内螺纹部分(220)和与所述内螺纹部分相邻的圆柱形导引部分(520)；
穿过所述孔插入骨中的骨螺钉(300)，所述骨螺钉具有：
设有第一外螺纹部分(32)的锚杆部分，所述第一外螺纹部分(32)布置成与骨的材料配合；
头部(36)，其直径大于所述锚杆部分的直径以提供锁扣部(35)，该锁扣部布置成与形成于所述孔(200)中的止动部(50)接合，并且所述头部包括第二外螺纹部分(330)，所述头部的第二外螺纹部分(330)布置成与所述孔的内螺纹部分(220)配合，并且当将骨螺钉(300)拧入所述孔(200)中之后，当所述锁扣部(35)与所述止动部(50)接合时所述第二外螺纹部分由所述圆柱形导引部分(520)接收，
其中所述圆柱形导引部分(520)定位在所述内螺纹部分(220)和所述止动部(50)之间，并且所述第二外螺纹部分(330)的螺纹长度(L1)与所述圆柱形导引部分(520)的长度相同。
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US8834570B2 (en) 2014-09-16
TW200904380A (en) 2009-02-01
CN103860248A (zh) 2014-06-18
ES2387506T3 (es) 2012-09-25
CN103860248B (zh) 2016-03-23
JP2009028537A (ja) 2009-02-12
TWI428117B (zh) 2014-03-01
US8790405B2 (en) 2014-07-29
JP2013106979A (ja) 2013-06-06
KR20090012109A (ko) 2009-02-02
KR101559861B1 (ko) 2015-10-13
CN101352367A (zh) 2009-01-28
US20130066428A1 (en) 2013-03-14
JP5485435B2 (ja) 2014-05-07
EP2340776B1 (en) 2013-01-30
JP5221232B2 (ja) 2013-06-26
US20090030520A1 (en) 2009-01-29
ES2404883T3 (es) 2013-05-29
EP2018827B1 (en) 2012-05-02
EP2340776A1 (en) 2011-07-06
EP2018827A1 (en) 2009-01-28

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