CN1725985A - 一种固定装置 - Google Patents
一种固定装置 Download PDFInfo
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- CN1725985A CN1725985A CNA2003801062912A CN200380106291A CN1725985A CN 1725985 A CN1725985 A CN 1725985A CN A2003801062912 A CNA2003801062912 A CN A2003801062912A CN 200380106291 A CN200380106291 A CN 200380106291A CN 1725985 A CN1725985 A CN 1725985A
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Abstract
本发明涉及一种供牢固旋入到骨组织中之用的固定装置。该固定装置包括一具有外螺纹(3)的普通圆柱形紧固部分(1)。所述紧固部分包括一开在所述紧固部分(1)插入端(4)的空腔(5)。数个连接所述空腔(5)与所述紧固部分(1)外部,自所述插入端(4)延伸的通透槽(9)。每个槽由一主导槽壁(13)和一从动槽壁(12)限定,所述的主导和从动槽壁与旋入固定装置时的螺纹所限定的旋转方向(A)相关。根据本发明,至少所述从动槽壁(12)的径向最外部与径向方向限定一角并沿所述旋转方向自内向外前倾。本发明还涉及此固定装置的用途以确保假体的安全。
Description
技术领域
本发明涉及一种所谓的可供牢固旋入到骨组织中的固定装置,其包括一具有外螺纹的普通圆柱形紧固部分,所述紧固部分有一开在所述紧固部分插入端的空腔,和数个自所述插入端延伸的通透槽,其中每个槽将空腔与紧固部分外侧连接,且其中每个槽是由一个主导槽壁和一个从动槽壁来限定的,而所述的主导和从动槽壁与旋入固定装置时的螺纹所限定的旋转方向相关。
背景技术
这种固定装置在外科修复术领域中使用,其中假体、假体零件或一假体架借助于一个或多个这种固定装置被紧固于患者的骨组织中。
然而,根据本发明的固定装置首先是为用来在凹的或者管状的骨头中紧固的并且可用于如指关节、髋关节等的关节再造。固定装置也能用于固定假腿或者其它类型的假体。然而,本发明不局限于这些应用。该固定装置有一个紧固部分和一个作用部分。将该紧固部分旋入骨组织中预先钻好的孔内。紧固部分该孔的直径小于紧固部分螺丝的外径。当排除骨碎片的时候,由于紧固部分为自出渣这样当被拧紧在其中的时候就在预钻孔的壁上形成一螺丝。把紧固部分旋入所述孔中是由所述槽推动的,是由于骨碎片从孔中被紧固部分外部和槽之间形成的边缘拉松动了。这些骨碎片通过槽被送至所述的空腔中。
在EP 0 595 782中有关于这种固定装置的一个例子的描述,其中固定装置的紧固端具有四个螺旋形的延伸槽。这个现有的固定装置已被发现在许多方面是非常令人满意的并且提供了用这种固定装置加固的假体的可靠性和紧固性。
然而,该现有的固定装置存在着某些缺陷。比如说,当该固定装置旋转的时候,骨组织被紧固部分外部与各槽的从动壁之间形成的边缘所作用。在径向槽壁和所述外部接口之间的边缘通常限定一直角。当旋入紧固部分,此边缘主要通过摩擦和扯松来自预钻孔壁的松散的骨碎片来作用于骨组织。这导致了在骨组织上的不利的生硬的动作。而且,如此松散的骨碎片是过大且呈不规则的形状。这使得在所述固定装置空腔中集中的骨材质的恢复和愈合难以完成。
该现有固定装置的另外一个缺陷是,当所述部件遭受到将所述紧固部件旋入预钻孔时所产生的径向压缩作用力时,所述径向槽导致紧固部分的几何形状变得不佳。作为所述压缩力的结果,紧固部分的旋转和径向内作用力的联合作用使位于槽之间的部分变得扭曲,于是导致加固部分变形成一非圆形状。这样减弱了锚固应力。虽然这种变形可以通过增加所述部件壁的厚度得以避免,但是壁厚度的增加会导致紧固部分变得僵硬和使它难以达到预期的径向弹力以获得强有力的紧固效果。
本发明的目的是在于提供一个可消除或至少减少上述缺陷的改进的固定装置。本发明主要目的是提供一所谓的固定装置,当旋入该固定装置时利用所述固定装置可将骨碎片顺利分离。
发明内容
本发明的目的是通过在紧固部分中的从动槽壁与径向方向限定一角,且在该固定装置按旋转方向由内向外前倾所实现的,所述的角度被至少限定在所述紧固部分的径向外部。
由于从动槽壁如此倾斜,此处限定了一个在所述壁与紧固部分外部之间的锐角。这个锐角的结果是可实现骨头在预钻孔壁中更有效和更轻柔的运动,以便骨碎片能被松散的切下,而不会象相应类型的先前已知固定装置所产生的磨损松散情况。锐角这样就提供了一个锋利的边缘,在分离所述骨碎片中像解剖刀一样工作。
根据本发明固定装置的一个较佳实施例,它不仅是限定该角的所述槽壁的径向最外部分,而且也是限定了同一角的从动槽壁的整个面。关于实际的运转过程,本质上其独自即可使外面部分倾斜。通过使整个槽壁倾斜,也获得了一个有利的几何形,用于当旋入所述紧固部分时固定装置紧固部分的径向压缩。当位于槽之间的紧固部分的那些部件被径向向内挤压的时候,倾斜延伸的从动槽壁会支撑主导槽壁,也就是说即使当所述紧固部分被径向压缩的时候也会保持圆形。位于槽之间的部分可以相应制造得薄一些,以便所述部分的弹力有利于紧固部分的径向压缩。当紧固部分在保持圆形的时候,其径向压缩的可能性有助于进一步获得更强更安全的加固。
根据本发明的另一个较佳实施例,主导槽壁在该固定装置按旋转方向由内向外前倾。因为这两个槽壁都是倾斜的,几何形情况被进一步改良,于是在当旋入所述紧固部分产生了径向压缩的期间有助于保持紧固部分的圆形。
根据本发明的另一个较佳实施例,限定在从动槽壁与所述径向方向间的角是在20°至40°之间。在这个角度范围内,这个角大得足以提供一个优良的切割作用,又小得足以避免破裂的危险或在切削边缘处的类似损坏。在大多数的应用中,在27°至33°范围内的角被认为是最合适的,其中大约30°的角可能是最合适的。
根据本发明的另一个较佳实施例,槽的数量是3到10个,优选为5到7个,合适的是6个。槽的最佳数目是变化的,主要是依固定装置的尺寸而变,换句话说就是依所使用的假体而变。槽的最佳数目也可能依靠其它因素。在许多例子中,包括大约6个槽的固定装置在为获得用于旋入紧固部分且也为获得安全、持久的加固的较佳的条件所必须遵守的两个方面之间形成最好的平衡。
根据本发明的另一个较佳实施例,所述空腔有一圆形断面形状并在朝插入端的方向锥形扩展。由于此锥形形状,那些位于槽之间的部件将有朝所述插入端厚度减小的舌形形状。朝向所述插入端的舌形的灵活性因此增强,从而实现所述舌的预期的径向回弹或弹力。
根据本发明的另一个较佳实施例,在所述槽(9)的径向外端的所述槽宽相应为所述固定装置外部的两槽间外围距离的15%-35%。槽宽和槽间距之间的关系使得在固定装置功能中的运转技术和强度技术面之间能够获得最佳平衡。
根据本发明的另一较佳实施例,固定装置由钛制成。虽然固定装置可以由其它任何合适的材料制成,比如说聚合材料,合成材料或其它的金属,但是更倾向于使用钛。已发现在所谓的骨整合术中将钛接合到骨质中不会发生把异物植入身体组织内所常见的那些不良反应。钛可以在分子层与骨组织相结合并融合在一起,这样钛就与骨组织接合了。于是一钛固定装置就可以很安全地被紧固了。
本发明固定装置的这些实施例在从属权利要求中很明显。
本发明还涉及本发明的固定装置将一假体安全置于骨组织中的用途。
该创造性的应用具有相对于本发明的固定装置及其最佳实施例的上述优点的各项优点。
现参照本发明的固定装置的一个实施例和附图对本发明进行详细的说明。
附图说明
图1为根据本发明的固定装置的纵截面视图;
图2为图1所示固定装置的自其插入端所视的端视图;
图3为根据图1的本发明的固定装置应用端所视的端视图。
(附图按5∶1的比例绘制)
具体实施方式
图1是本发明的固定装置的纵截面图。所绘的固定装置是供指关节使用并且其尺寸也是为此目的定制的。该固定装置包括一紧固部分1和一作用部分2。紧固部分的长度约为20mm而作用部分的长度约为10mm。
紧固部分包括一可将固定装置旋入骨组织预钻的孔中的适合的外螺纹3。在所绘制的图中,该螺纹为一M6螺纹。预钻的孔的直径最好比该螺纹内径略小一些,即大约4.5mm的直径。该螺纹3沿所述紧固部分2的全长延伸。
所述紧固部分包括一空腔5,其在紧固部分中从其中的插入端4沿着轴向和中心延伸。该空腔大约有12mm的深度并包括最远的一短的圆柱部分6和一个位于所述的圆柱部分和插入端之间的圆锥部分7。相应于4°的锥角,该圆锥部分有大约10mm长,一个约为3mm的最小直径和一个约为4.4mm的最大直径。
紧固部分1在其插入端4有一个斜面8,有助于将紧固部分1旋入到预钻的孔中。所述斜面沿固定装置延伸约2mm并且有一个大约15°的角。
如前所述,图2从插入端所视的固定装置的端视图。如图2所示,6个槽布置于固定装置紧固部分1的四周。每个槽连接着空腔5与紧固部分1的外表面并且从插入端起沿着空腔5的主体部分轴向向上延伸。由此导致了在槽间舌状部分的形成,每个舌状部分10的厚度向插入端4方向减少。
每个槽是由两个相互平行的槽壁所限定的,即由旋入紧固部分时的旋转方向A所视的一主导槽壁13和一从动槽壁12,每个槽在所述的旋转方向向前和向外倾斜。所述槽壁12和13于是与径向方向限定一角α,所述的角α是就各槽壁与紧固部分外表面的交叉点来测的。在所描绘的实例中,角α大约为30°。
由此,在从动槽壁12和紧固部分外部之间形成一个锐边13,在旋入紧固部分时所述边就形成了一切割边,该切割边有一个约60°的顶角。每个槽的宽度大约为0.5mm,也就是说,两槽壁间距大约是0.5mm。
图3是从应用端所视的该固定装置的端视图。应用端可以用不同方法设计。在本实施方式中,所述应用端包括一直径为2.5mm的中心孔15。所述应用端上部有一六边形16,当旋入紧固部分时可以在其上使用工具。
所描述的固定装置按下面所述方式安全设置。
首先,在要加固所述固定装置的骨组织中钻一孔。所钻孔的直径应比所述紧固部分1上螺丝的内径小。
然后固定装置进入所述预钻孔,紧固部分插入端4上的斜面8使其变得容易,并且所述固定装置在一个用于六边形16的转动工具的帮助下顺着箭头A的方向旋转。接着所述固定装置旋入所述孔中,于是在此处攻出螺纹。这是在槽9尤其是在由各从动槽壁12的切割边14的帮助下达成的。
锋利的切割边14从预钻孔壁中的骨材质中切下松散的碎片,这些碎片是通过槽9传送并且收集在所述固定装置的紧固部分的空腔5中。同时,在槽9之间形成的舌状部分10被从预钻孔的限定壁施加的压力径向向内挤压,之后,各槽壁被挤压靠近在一起,从而减小槽间宽度。槽的倾斜导致在其中形成一支持作用。槽的这种倾斜和所述的支持作用使所述紧固部分或加固部分能够在被径向压缩的时候保持其圆形形状。
从骨组织所钻孔的壁上切下的碎片被收集在空腔中并且随后在重组的骨组织的紧固中有助于加强紧固。
Claims (10)
1、一种供牢固旋入到骨组织中之用的固定装置,包括一具有外螺纹(3)的普通圆柱形紧固部分(1),所述紧固部分有一开在所述紧固部分插入端(4)的空腔(5),以及数个自所述插入端(4)延伸的通透槽(9),其中每个槽(9)将所述空腔(5)与所述紧固部分(1)的外侧连接,且其中每个槽(9)由一主导槽壁(13)和一从动槽壁(12)限定,而所述的主导和从动槽壁与旋入固定装置时的螺纹(3)所限定的旋转方向(A)相关,其特征在于,至少所述从动槽壁(12)的径向最外部与径向方向限定一角(α)并沿所述旋转方向(A)自内向外前倾。
2、根据权利要求1所述的固定装置,其特征在于,整个所述从动槽壁(12)限定一相同的所述角(α)。
3、根据权利要求2所述的固定装置,其特征在于,所述主导槽壁(13)也沿所述旋转方向(A)自内向外前倾。
4、根据权利要求3所述的固定装置,其特征在于,所述槽壁(12,13)是相互平行的。
5、根据权利要求1-4中任一项所述的固定装置,其特征在于,在从动槽壁(12)的径向外端的所述角(α)为20°-40°,最佳为27°-33°。
6、根据权利要求1-5中任一项所述的固定装置,其特征在于,所述槽(9)的数目为3-10个,最好是5-7个。
7、根据权利要求1-6中任一项所述的固定装置,其特征在于,所述空腔(5)的横截面为圆形且向所述的插入端(4)的方向呈圆锥形扩展。
8、根据权利要求1-7中任一项所述的固定装置,其特征在于,在所述槽(9)的径向外端的所述槽宽相应为所述固定装置外侧的两槽间外围距离的15%-35%。
9、根据权利要求1-8中任一项所述的固定装置,其特征在于,所述固定装置是由钛制成的。
10、如权利要求1-9中任一项所述的固定装置的用途,其用于将一假体紧固于骨组织中。
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SE526682C2 (sv) | 2005-10-25 |
EP1575447B1 (en) | 2009-03-11 |
BR0317532A (pt) | 2005-11-22 |
JP2006510445A (ja) | 2006-03-30 |
KR20050091009A (ko) | 2005-09-14 |
US20060173460A1 (en) | 2006-08-03 |
WO2004056285A1 (en) | 2004-07-08 |
SE0203786D0 (sv) | 2002-12-19 |
JP4578246B2 (ja) | 2010-11-10 |
DE60326643D1 (de) | 2009-04-23 |
PT1575447E (pt) | 2009-05-08 |
CN100467003C (zh) | 2009-03-11 |
KR101021401B1 (ko) | 2011-03-14 |
AU2003289697A1 (en) | 2004-07-14 |
BR0317532B1 (pt) | 2013-05-07 |
US7753942B2 (en) | 2010-07-13 |
EP1575447A1 (en) | 2005-09-21 |
SE0203786L (sv) | 2004-06-20 |
ATE424782T1 (de) | 2009-03-15 |
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