CN1897884B - 骨锚定元件和包括这种类型的骨锚定元件的用于骨或脊椎骨的稳定装置 - Google Patents

骨锚定元件和包括这种类型的骨锚定元件的用于骨或脊椎骨的稳定装置 Download PDF

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CN1897884B
CN1897884B CN2004800381328A CN200480038132A CN1897884B CN 1897884 B CN1897884 B CN 1897884B CN 2004800381328 A CN2004800381328 A CN 2004800381328A CN 200480038132 A CN200480038132 A CN 200480038132A CN 1897884 B CN1897884 B CN 1897884B
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anchoring element
osseous anchoring
bar
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bone
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CN1897884A (zh
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L·比德曼
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Biedermann Technologies GmbH and Co KG
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Biedermann Motech GmbH and Co KG
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Abstract

本发明涉及一种骨锚定元件例如骨螺钉(1)，其包括一用于锚定在骨中的钉杆(2)，其中该钉杆具有一弹性部分(4)。弹性部分(4)优选构成为螺旋弹簧。还涉及一种用于骨例如脊椎骨的稳定装置，其具有至少一个本发明的骨锚定元件(1)、一第二骨锚定元件和一将各骨锚定元件连接的杆或板。

Description

骨锚定元件和包括这种类型的骨锚定元件的用于骨或脊椎骨的稳定装置
技术领域
本发明涉及一种骨锚定元件和一种包括这种类型的骨锚定元件的用于骨或脊椎骨的稳定装置。
背景技术
为了固定骨折部分或稳定脊椎柱已知多种固定以及稳定装置，其包括至少两个在骨或脊椎骨中锚定的并经由一板或一杆连接的骨螺钉。这样的刚性系统不允许相对彼此固定的各骨部分或脊椎骨的运动。
但为了某些症状，需要动态的稳定，其中待稳定的各骨部分或脊椎骨可以进行一受控的有限的相互运动。一种实现动态的稳定装置的可能性在于采用一可移动的元件来代替一连接各骨锚定元件的刚性杆，如其例如在EP 0 669 109 B1或US 2003/010 9880 A1中所描述的。
由US 5 474 555已知一种多轴骨螺钉的形式的骨锚定元件用以与一杆相连接，所述骨锚定元件包括一螺钉元件和一容纳件，其中待固定于骨中的螺钉元件与容纳件连接成使在螺钉元件与容纳件之间的转动运动是可能的。但所述解决方案不允许具有一受控的局部运动的各骨部分彼此之间的稳定。
由EP 1 273 269已知一种具有柔性钉杆的骨螺钉。螺钉这样安装，即螺钉将骨部分或两骨相互连接并且用作为牵引元件。通过柔性钉杆阻止在牵引方向上的相对运动，而允许在其它的方向较小范围的运动。如果安装两个或更多个螺钉，则它们并不相互连接。分别由DE 299 15204 U1和US 4 959 064已知一种类似的螺钉。
发明内容
本发明的目的是，提供一种骨锚定元件和一种用于骨或脊椎骨的包括一这样的骨锚定元件的稳定装置，它们允许在待稳定的骨部分或脊椎骨受控地局部运动的情况下稳定骨或脊椎骨。
上述目的通过这样的骨锚定元件实现，其包括一用于锚定在骨中的钉杆，所述钉杆具有一可锚定在骨中的第一部分和一弹性构成的第二部分；以及包括一钉头，所述钉头构造成用于连接一将至少两个骨锚定元件相连接的杆，其中所述第二部分具有一与钉杆轴线共轴的孔，并且第二部分具有一在钉杆的壁中沿钉杆轴线方向螺旋形延伸的间隙。
上述目的此外通过这样的用于稳定骨的稳定装置实现，其包括至少两个骨锚定元件和一个将它们连接的外部的装置，其中至少一个骨锚定元件具有包括一弹性部分的钉杆，所述弹性部分具有一与钉杆轴线共轴的孔，并且所述弹性部分具有一在钉杆的壁中沿钉杆轴线方向螺旋形延伸的间隙。优选钉头和钉杆相互铰接连接。此外优选钉头相对于钉杆的角位置是可锁定的。
本发明的优点是，骨锚定元件由于一弹性部分吸收沿其钉杆轴线方向的轴向力、弯曲应力和扭应力.借此允许骨部分或脊椎骨的通过回复力限定的运动，骨锚定元件固定在所述骨部分或脊椎骨中.制造时按简单的方式通过改变弹性部分的尺寸实现骨锚定元件的弹性特性.该骨锚定元件可与已知的连接元件如板和杆连接.因此在使用传统的板或杆的应用情况下通过选择具有适当的弹性特性的骨锚定元件可以提供一种具有一期望的运动限制的动态的稳定装置.
附图说明
由借助附图阐述的各实施例得出本发明的其它的特征和合理性。其中：
图1骨锚定元件的第一实施形式的剖视图；
图2按第一实施形式的一稳定装置的示意图，其具有按图1的骨锚定元件；
图3a  按第二实施形式的骨锚定元件的侧视图，其包括一插入的杆；
图3b  按图3a的线I-I截取的骨锚定元件的局部剖面图；
图3c  图3a的骨锚定元件的透视图，无插入的杆；
图4第三实施形式的骨锚定元件的局部剖面图；
图5按第二实施形式的一稳定装置的示意图，其采用按第三实施形式的骨锚定元件；
图6a  骨锚定元件的第四实施形式的分解图；
图6b  图6a的包括一进一步构造的实施形式的一部分的剖面图；
图6c  图6b的所述部分沿线A-A截取的剖视图；
图7a  按第五实施形式的骨锚定元件的侧视图；
图7b  按图7a的骨锚定元件的剖视图；以及
图8稳定装置的第三实施形式的示意图。
具体实施方式
如由图1和2显而易见的，骨锚定元件1在第一实施形式中构成为一体的骨螺钉，其包括一钉杆2，钉杆2具有一待固定于骨中的包括骨螺纹的第一部分3和一邻接第一部分3的无骨螺纹的第二部分4；以及包括一邻接第二部分的钉头5。从钉头5的自由端开始共轴于螺钉轴线A延伸一盲孔6，其以预定的直径穿过钉头5和第二部分4。在第二部分4的区域内钉杆2具有一沿螺钉轴线方向以预定的螺距螺旋形延伸的、沿一预定的长度延伸的并且在径向方向通入孔6的间隙7。借此第二部分4以一螺旋弹簧的形式构成为弹性的。弹性部分沿螺钉轴线方向的长度L、间隙7沿螺钉轴线方向的高度H、螺旋线的螺距和共轴的孔6的直径选择成使螺旋弹簧相对于作用到骨螺钉上的轴向力、弯曲力和扭转力具有一要求的刚度。
钉头5在所示实施例中构成透镜状的并且在其自由端具有一用于内六角扳手的六角形凹槽8。但其它的钉头形式和/或其它的凹槽例如十字凹槽也可以用于嵌入一拧紧工具。
一按照第一实施形式的稳定装置如图2中所示包括一按照图1的骨螺钉形式的第一骨锚定元件1和一第二骨锚定元件11，此第二骨锚定元件可以构成为传统的无弹性部分的骨螺钉，以及包括一板12，其具有孔隙12、13用于穿过骨螺钉的钉杆。
在图2所示的应用实例中稳定装置设置用来稳定两个脊椎骨15、16，这两个脊椎骨在移除椎间盘以后或在移除居中的脊椎骨以后应该经由一融合元件17例如一钛圆柱体相互刚性连接。
在操作中首先将骨螺钉1、11的钉杆穿过板的孔隙12、13并紧接着拧紧入相应的脊椎骨15、16中，直到板12紧贴脊椎骨。此时骨螺钉1的弹性部分4埋入脊椎骨中。在这种情况下使脊椎骨只能在螺钉轴线的方向作有限的运动。当融合元件向内生长时它开始沉入骨中，骨螺钉由于弹性部分而稍微松弛。由此防止产生不利的应力。
在所示的稳定装置中也可以采用两个或更多个具有弹性部分4的骨螺钉。在多于两个螺钉的情况下板具有相应数目的孔隙。该稳定装置不仅适用于在脊椎柱上的应用，而且可应用于其它的实施板接骨术的情况中。
一按照图3a至3c中所示的第二实施形式的骨锚定元件21构成为单轴骨螺钉，用于与杆100相连接。单轴骨螺钉包括一钉杆22，其具有一待固定于骨中的包括骨螺纹的第一部分23和一邻接第一部分23的无骨螺纹的第二部分24，单轴骨螺钉还包括一与钉杆22一体连接的用于容纳杆100的容纳部分25。容纳部分25基本上圆柱形构成并且从其自由端开始具有一U形横截面的凹槽26，凹槽26的尺寸刚好确定成，使得杆100可以插入并且配合入凹槽26的底部中。通过U形的凹槽26构成两个自由侧臂27、28，它们在自由端的邻近处具有内螺纹29，所述内螺纹29与一待在两侧臂之间拧入的内螺钉31的相应的外螺纹30相配合，以便固定杆100。
如特别是由图3b显而易见的，一共轴的具有预定深度的孔32从U形凹槽26的底部向骨螺纹部分23的方向延伸穿过无骨螺纹的部分24。如同在第一实施形式中，钉杆在第二部分24的区域内也具有一沿螺钉轴线方向螺旋形延伸的间隙33，其在径向方向通入孔32。由此第二部分24是弹性的并用作螺旋弹簧。
一按照第二实施形式的稳定装置包括至少一个骨锚定元件，其构成为包括弹性部分24的单轴螺钉；一第二骨锚定元件，其构成为传统的无弹性部分的单轴或多轴的骨螺钉；以及一杆。代替使用传统的单轴或多轴的骨螺钉作为第二固定元件，稳定装置也可具有两个按照图3a-3c的单轴骨螺钉。
在操作中将骨锚定元件拧紧入相应的骨中或在应用在脊椎柱上时拧紧入相应的脊椎骨中，紧接着将杆100插入容纳部分中，然后经由内螺钉将其固定。此时将单轴骨螺钉21拧入到这种程度，使得弹性部分24至少部分地凸出于骨或脊椎骨的表面。在骨或脊椎骨从待稳定的静止位置开始运动时，经由弹性部分24对骨或脊椎骨施加一回复力，此回复力使它们再次回到静止位置并从而限制运动。
可替换地，可以将骨螺钉拧入到这种程度，使得弹性部分24不或仅仅微小地凸出于骨的表面。在这种情况下由于弹性部分的弹性作用可以在校准之后形成松弛。
在图4中所示的第四实施形式中，骨锚定元件41构成为多轴骨螺钉。所述多轴骨螺钉包括一体构成的钉杆42，此钉杆42具有一待锚定于骨中的第一部分43和一与所述第一部分43邻接的无骨螺纹的第二部分44；以及一邻接第二部分44的截球形的钉头45。钉头45支承在一容纳部分46中。第二部分44如同在上述各实施形式中构成为螺旋弹簧并且具有一共轴的孔47，其从钉头的自由端延伸穿过第二部分，并且在壁中具有一成螺旋形延伸的间隙48。
容纳部分46基本上圆柱形构成并在其一端具有一轴向对称对准的第一孔49，此孔的直径大于钉杆42的直径，小于钉头45的直径。此外容纳部分46具有一共轴的第二孔50，此第二孔50在对置于第一孔49的端部是敞开的并且其直径选择得足够大，使得螺钉元件通过所述敞开的端部，钉杆穿过第一孔49，直至钉头45紧贴第一孔49的边缘。容纳部分46如同上述的实施形式的容纳部分25具有一从自由端向第一孔49的方向延伸的U形凹槽，由此U形凹槽构成两自由侧臂52、53。侧臂52、53在邻接它们的自由端的区域内具有内螺纹，其与一内螺钉54的相应的外螺纹相配合，以便固定杆100。
此外设置一压力元件55以便将钉头固定在容纳部分中，该压力元件构成为使得在其面向钉头45的一侧具有球形的凹槽56，其半径基本上等于钉头45的截球形部分的半径。压力元件55的外径选择成使得压力元件可在容纳部分46中向钉头45那边移动。该压力元件还具有一共轴的孔57，其允许拧紧工具嵌入钉头45中的一未示出的凹槽。
一按照第三实施形式的稳定装置包括至少两个骨锚定元件和一杆，其中至少一个骨锚定元件构成为具有一钉杆的多轴骨螺钉，所述钉杆具有一弹性部分44。第二骨锚定元件可以构成为传统的无弹性部分的单轴或多轴骨螺钉或构成为具有一上述弹性部分的单轴或多轴骨螺钉。
在操作中首先将螺钉元件插入容纳部分中，直至钉头45紧贴第一孔49的边缘。然后将螺钉元件拧紧入骨或脊椎骨中，其中弹性部分44至少部分地凸出于骨表面。紧接着插入杆，校准容纳部分相对于螺钉元件的角位置并紧接着通过内螺钉的拧紧固定。如在上述的实施形式中，通过弹性部分能够实现围绕静止位置的有限的运动。
可替换地，也可以将杆如此拧紧入骨中，使得弹性部分不或只微小地凸出于骨表面。
图5为一按照第三实施形式的稳定装置的应用实例，用以稳定两个脊椎骨58、59，它们经由一应当替换一移除的椎间盘的融合无件60相互连接。如以上所述进行操作。脊椎骨58、59相互的有限的运动导致一提高的循环的局部载荷，借此促进骨生长并快速加速成骨。
图6a中所示的骨错定元件61的第四实施形式与图4中所示的第三实施形式的区别在于螺钉元件的构成。所有其它的构件相同于第三实施形式。
在按第四实施形式的螺钉元件中骨螺纹部分63、弹性部分64和钉头65构成为单独的部分。弹性部分64包括一圆柱形管，其具有一贯通的共轴的孔66和成螺旋形沿圆柱轴线方向在壁中延伸的间隙67，其在径向方向通入孔66。借此构成一如同在上述各实施形式中的螺旋弹簧。弹性部分64在各个自由端的邻近处在两端具有一沿一预定的长度延伸的内螺纹68。骨螺纹部分63在其对置于待拧入的尖端的端部具有一包括外螺纹的圆柱形的伸出部分69，所述外螺纹与弹性部分64的内螺纹68相配合。
钉头65在其对置于削平的端部的一侧具有一包括外螺纹的圆柱形伸出部分70，所述外螺纹与弹性部分的内螺纹68相配合。
在操作中不同于上述的实施形式首先通过将骨螺纹部分63、弹性部分64和钉头65拧在一起而组装成螺钉元件并然后将其插入容纳部分中。此外的操作如同在上述实施形式中那样进行。
按该实施形式的骨锚定元件的优点是，制造简化了.此外其优点是，可以提供不同长度和不同刚度的弹性部分64，并且根据应用在使用之前进行选择并且可以与一定尺寸的钉头和预定长度的螺纹杆组合成一螺钉元件.
图6b示出图6a的弹性部分64的进一步构成。按图66的弹性部分640在其内部具有一芯体641。芯体在其备端642构成圆柱形的，其直径确定成使芯体可插进弹性部分640的空腔中。备圆柱形部分642和弹性部分640具有横向延伸的孔，在其中插入销643以便固定芯体。芯体在两圆柱形端部之间具有一基本上矩形横截面的部分644，如特别由图6c显而易见的。在一改变方案中芯体具有其它的横截面，例如椭圆形或不对称的。芯体可以调整弹性部分的弯曲刚度和/或扭转刚度。弹性部分相对在一确定方向上的弯曲的刚度取决于芯体在弹性部分内的定向。优选芯体由具有比弹性部分的材料的刚度小的材料构成。所示的芯体的固定只是示例性说明。
在图7a和7b中所示的另一实施形式中骨锚定元件构成为自攻螺钉81(Schanz screw)。自攻螺钉81具有一第一螺纹部分82和一与其相邻的圆柱形的无螺纹的无钉头的钉杆部分83，一从自由端到螺纹部分延伸的共轴的盲孔84延伸穿过所述钉杆部分。在圆柱形部分83的一预定的区域85内在壁中设置一成螺旋形在螺钉轴线方向上在预定长度上延伸的间隙86，正如在上述的各实施形式中构成一螺旋弹簧形式的弹性部分。此外圆柱形钉杆部分在圆周面具有以一预定的彼此间距设置的圆形的刻槽87。圆柱形钉杆部分邻接其自由端具有一六角形凹槽88或一任何其他的凹槽以便嵌入拧紧工具。
在操作中特别在一外部的固定器中将自攻螺钉81与传统的自攻螺钉以及传动的连接元件和固定杆一起应用。将自攻螺钉81拧紧入待固定的骨断片中，使得弹性部分85凸出骨表面以外，可选择地也可凸出皮肤表面以外。根据弹性部分的刚度能够在预定的位置作有限的运动。
图8示出一按图7a和7b的进一步构成在一外部的固定器中的应用，以便稳定一断裂的管状骨的管状骨部分90、91。自攻螺钉92为此如同第三实施形式的多轴螺钉41具有一(未示出的)截球形钉头，此钉头支承在一容纳部分93中。经由自攻螺钉92和传统的多轴骨螺钉94稳定骨部分90、91，所述自攻螺钉92和传统的多轴骨螺钉94经由一连接元件95与杆100、101相互连接。
上述各实施形式的改变是可能的。特别是一实施形式的各元件可以与另一实施形式的各元件相组合。按照图6a的实施形式的螺钉元件的多元件的构成也可以用在按照图3a至3c的单轴骨螺钉中，其中容纳部分可拧紧入弹性部分中。此外按图7a和7b的自攻螺钉也可构成多元件的。在另一改变中骨螺纹部分和弹性部分结合成一件并且只可拧入钉头或容纳部分。
在另一实施形式中设置一单独的圆柱形芯体，其插入穿过弹性部分的孔中。借此可以附加调整弹性部分的刚度。在另一实施形式中弹性部分具有不同于骨螺纹部分的另一直径。在一较大的直径的情况下可以提高刚度。芯体也可以具有不同于圆柱形的形状。例如它可以具有一矩形横截面的部分，如图6b和6c中所示。
本发明并不限于具体描述的各个单轴和多轴的骨螺钉的实例。其其它的构成特别是对于容纳部分和固定装置而言是可能的。决定性的是，钉杆具有一弹性部分。此外本发明也可应用在钩子上。
在另一实施形式中弹性部分设有一软管状的外套，其阻止组织材料或血管的长入.
在全部上述的实施形式中的优点是，骨部分或脊椎骨的有限的运动可能性导致提高的循环的局部载荷，其促进骨生长。
按照本发明的稳定装置包括至少两个骨锚定元件，它们分别与一外部的装置例如一板或一杆相连接。骨锚定元件与板或杆之间的连接优选是牢固的。在骨或骨部分运动时经由外部的装置作用到骨锚定元件的钉头上的力通过弹性钉杆与锚定脱离联系，从而降低在骨中锚定松弛的危险。稳定装置可特别用于稳定椎柱。
采用身体适宜的材料作为骨锚定元件或其构件的材料。例如采用身体适宜的材料例如钛或一种身体适宜的塑料。也可以使用一种具有已知的超弹性特性的形状记忆合金例如Nitinol。在这种情况下骨锚定元件可以完全由这样的合金构成，包括在弹性部分中的芯体在内，或仅仅芯体或仅仅弹性部分由所述合金构成。同样可设想对固定元件的不同的部分采用不同的材料。

Claims (15)

1.一种骨锚定元件，包括一用于锚定在骨中的钉杆(2；22；42；63；64；82，83)，所述钉杆具有一可锚定在骨中的第一部分(3；23；43；63；82)和一弹性构成的第二部分；以及包括一钉头，所述钉头构造成用于连接一将至少两个骨锚定元件相连接的杆，其中所述第二部分(4；24；44，64；85)具有一与钉杆轴线共轴的孔(6；32；47；66；86)，并且第二部分具有一在钉杆的壁中沿钉杆轴线方向螺旋形延伸的间隙(7；33；48；67；86)。
2.按照权利要求1所述的骨锚定元件，其特征在于，钉杆(2；12；42；82，83)是一体构成的。
3.按照权利要求1所述的骨锚定元件，其特征在于，第二部分构成为单独的部分(64)。
4.按照权利要求1所述的骨锚定元件，其特征在于，用于与一杆(12；100)相连接的钉头(5；25；45)与钉杆一体构成。
5.按照权利要求1所述的骨锚定元件，其特征在于，用于与一杆(12；100)相连接的钉头(65)构成为与钉杆分离的部分。
6.按照权利要求4或5所述的骨锚定元件，其特征在于，第二部分设置成与钉头邻接。
7.按照权利要求1至3之一项所述的骨锚定元件，其特征在于，骨锚定元件为一骨螺钉(1；21；41；61；81)。
8.按照权利要求1至3之一项所述的骨锚定元件，其特征在于，钉头基本上圆柱形构成，并且在其远离钉杆的端部具有一用于插入杆的U形凹槽。
9.按照权利要求1至3之一项所述的骨锚定元件，其特征在于，钉头和钉杆相互刚性连接。
10.按照权利要求1至3之一项所述的骨锚定元件，其特征在于，钉头和钉杆相互铰接连接。
11.按照权利要求10所述的骨锚定元件，其特征在于，钉头相对于钉杆的角位置是可锁定的。
12.一种用于稳定骨的稳定装置，包括至少两个骨锚定元件和一个将它们连接的外部的装置，其中至少一个骨锚定元件具有包括一弹性部分的钉杆，所述弹性部分具有一与钉杆轴线共轴的孔(6；32；47；66；86)，并且所述弹性部分具有一在钉杆的壁中沿钉杆轴线方向螺旋形延伸的间隙(7；33；48；67；86)。
13.按照权利要求12所述的稳定装置，其特征在于，各骨锚定元件与板或杆固定连接。
14.按照权利要求12或13所述的稳定装置，其特征在于，外部的装置为一板。
15.按照权利要求12或13所述的稳定装置，其特征在于，外部的装置为一杆并且至少一个骨锚定元件按照权利要求1至11之任一项进行构造。
CN2004800381328A 2003-11-07 2004-11-06 骨锚定元件和包括这种类型的骨锚定元件的用于骨或脊椎骨的稳定装置 Expired - Fee Related CN1897884B (zh)

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DE2003151978 DE10351978A1 (de) 2003-11-07 2003-11-07 Knochenverankerungselement und Stabilisierungseinrichtung für Knochen bzw. für Wirbel mit einem derartigen Knochenverankerungselement
US60/518,469 2003-11-07
US52394603P 2003-11-21 2003-11-21
US60/523,946 2003-11-21
US55018204P 2004-03-03 2004-03-03
US60/550,182 2004-03-03
PCT/EP2004/012592 WO2005044123A1 (de) 2003-11-07 2004-11-06 Knochenverankerungselement und stabilisierungseinrichtung mit einem derartigen knochenverankerungselement

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EP1925264A2 (de) 2008-05-28
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EP2263583A3 (de) 2011-01-19
CN100581493C (zh) 2010-01-20
EP1684652A1 (de) 2006-08-02
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EP1696809A2 (de) 2006-09-06
EP1832241A1 (de) 2007-09-12
DE502004011714D1 (de) 2010-11-11
CN1897884A (zh) 2007-01-17
CN1893884A (zh) 2007-01-10
EP1832241B1 (de) 2010-08-18
EP1696809B1 (de) 2009-08-05
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