CN103054661B - 多壁的位置支撑器 - Google Patents
多壁的位置支撑器 Download PDFInfo
- Publication number
- CN103054661B CN103054661B CN201210570791.2A CN201210570791A CN103054661B CN 103054661 B CN103054661 B CN 103054661B CN 201210570791 A CN201210570791 A CN 201210570791A CN 103054661 B CN103054661 B CN 103054661B
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- China
- Prior art keywords
- tubular body
- position holder
- shape
- tubular
- bodies
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Abstract
本发明涉及具有管状主体(4)、尤其用于椎骨或椎间盘的位置支撑器,沿着其护套表面(10)具有多个与相邻组织长在一起的通孔或开口(9)。位置支撑器包括至少一个有多个通孔和开口(9)的第二管状主体(2,3),其至少部分位于第一管状主体之内。第一和第二管状主体可以具有不同的横截面形状,可以通过压配合或过盈配合设在彼此之内,或者通过连接销或固定板连接。数个第二主体可以并排设置在第一主体中。本发明还涉及模块系统,包括:多个管状主体(2,3,4),它们在护套表面(10)上具有多个开口(9)或通孔,并具有不同的尺寸,使得至少两个不同的管状主体可以至少部分地设在彼此之内;以及连接管状主体的连接部件(8,13,14)。
Description
本申请是申请日为2006年12月25日、发明名称为“多壁的位置支撑器”的第200610161774.8号专利申请的分案申请。
技术领域
本发明涉及植入人体或动物体内的位置支撑器,具体涉及用于椎骨或椎间盘的位置支撑器,这种位置支撑器的制造方法以及模块系统。
背景技术
位置支撑器,尤其是用于椎骨或椎间盘的位置支撑器,已经公知了很长时间。例如,DE19504867C1揭示了一种圆柱-管状主体形状的位置支撑器,该圆柱管状主体具有多个按横排和竖列布置的斜方形或菱形开口。在圆柱管的末端设有对应于斜方形的突起锯齿和凹陷,用于与相邻椎骨或相邻组织接合。菱形开口促使组织向内长入植入物中,使得后者可以很好地与机体紧密结合。
此外,US2005/0015154公开了一种植入物,其具有类似于脚手架的结构,其中,格状结构延伸至植入物的全部主体或穿过整个主体。这种一体的格状结构尤其用作髋关节、膝关节、肩关节等关节的替代植入物。但是,这种一体的格状结构很难制造,而且必须进行调节并个别地制造出来以适合每种应用情况。
DE10138079A1揭示了一种可调节轴向长度的位置支撑器,其中,两个类似于套筒的部件通过杆结构可调节地一个设置在另一个之内,所述部件通过所述杆结构而连接。尽管这种装置有利于非常精确的长度调节,但是所述杆结构制造起来十分复杂。
DE19804765C2揭示了一种可调节轴向长度的、用于插在两个椎骨之间的位置支撑器。通过相对于内部管移动外部管,可以调节总长度。其长度调节是借助于钩子(catch)逐步进行的。
DE69719431T2说明了一种纵向可调的椎间盘位置支撑器,其中,两个套筒主体可伸缩地设置成其中一个位于另一个之内,可以相对于彼此进行调节,且可以通过螺钉结构而被锁定。但是,这种设置不能将荷载均匀地分布到整个螺钉连接上,且由于套筒主体的紧密设置而不能有效地允许周围组织向内生长。
US2003/0073660揭示了一种可以用作位置支撑器的植入物,其中,植入物具有皱褶的、类似于套筒的主体。这种皱褶状主体可以设置在另一个套筒主体之内。但是,一个植入物部件的皱褶形式也使得制造起来十分复杂。
EP0904751A1说明了一种用于椎骨的管状支撑主体,其具有两个在彼此中引导的机架,所述机架可以通过一个机架的护套表面上的突起柱和另一个机架的护套中的轴向凹槽彼此连接。这种设置简化了在不同深度处的锁定位置的设置。但是,凹槽限制了支撑主体的可变性。
发明内容
因此,本发明的目的在于,提供一种植入物,其易于制造,具有多种用途,另外,在分散荷载和容易向内长入人体或动物组织方面也具有优良特性。此外,本发明的植入物尤其适于用作脊骨中的位置支撑器,即用作椎间盘和椎骨的位置支撑器,而且也适用于上肢和下肢的管状骨。
上述目的通过具有权利要求1,4,5,8或9所述特征的位置支撑器以及具有权利要求43所述特征的模块系统来实现。权利要求44给出一种对应的位置支撑器的制造方法。各从属权利要求给出本发明的优选实施例。
本发明起始于DE19504867C1所揭示的位置支撑器,其在实际应用中已经证明了自身的价值,尤其是在用作椎间盘的位置支撑器、用作脊骨的椎骨的位置支撑器、以及用作上肢和下肢的管状骨的位置支撑器这些方面。按照本发明,进一步改进了这种位置支撑器,使得数个这样的管状主体设置成其中一个位于另一个之内,形成多构件或多壁的位置支撑器。
按照本发明的第一方面,数个管状主体,即第一管状主体和至少一个第二管状主体,被设置成其中一个至少部分地位于另一个之内,形成多壁的位置支撑器,其不仅具有优良的荷载吸收性能,还特别适用于允许相邻组织向内生长。所述位置支撑器的特征在于,在垂直于位置支撑器纵轴的横截面上,第一和第二主体的横截面形状不同,具体而言,设置在第一主体中的第二主体具有简单的几何基本形状。这里,简单的或基本的几何形状主要是指容易制造的形状,即,尤其是指但并不专指具有圆形、椭圆形、矩形或三角形横截面的圆柱体或立方体形状。以这种方式,第一和第二主体的简单几何基本形状可以使其具有适于使用的机械性能,同时可以简单地制造。此外,有利于在其前表面处形成与骨的大接触表面。所以,尤其是在椎骨骨质疏松的情况下,可以防止位置支撑器下沉或在相当程度上减小下沉的风险。本发明的位置支撑器可以包括多个嵌套在彼此之内的第二管状主体,它们都至少部分地位于第一管状主体中。
优选的是,第一主体可以具有圆形横截面形状,而第二主体可以具有三角形、正方形、六边形、八边形或通常为多边形、椭圆形或者肾形的横截面形状。
在另一优选实施例中,第一或外部管状主体可以具有除了圆形以外的横截面形状,尤其是椭圆形或肾形的横截面形状,这种情况下,第二主体可以具有相应调整后的不同的上述横截面形状。
按照本发明的第二方面,本发明想要独立地保护这一方面以及它与其它方面的结合,可以在第一主体中并排设置数个第二主体。因此,这种设置一方面也可以获得显著的机械稳定性和/或另一方面让周围组织易于向内生长到位置支撑器之内。尤其是,各个部件即管状主体的壁厚,可以通过这种手段保持为很小。这也就促使组织向内生长到管状主体中因而长入到植入物中。
通过在第一主体中设置数个第二主体,具体为两个或三个第二主体,可见减小各个管状主体的壁厚,同时可以提高总的荷载能力。在第一主体中设置两个、三个或数个第二主体,这种设置适用于本发明公开的所有方面。
第二主体可以相对于彼此和/或相对于第一主体隔开,这是因为,主体之间的间隙有利于促进机体组织在主体之间向内生长。此外,主体之间的间隔使得荷载输入更均匀地分布到植入物的横截面上。
在第一主体中设置数个第二主体的情况下,第二主体的设置优选使得它们的纵轴平行于第一主体的管体纵轴偏置。其结果在于,对于机械荷载的某些情况可以获得更大的稳定性。例如,主体的偏置设置可以导致在弯曲应力情况下的更大稳定性。
总体上说,第一和/或第二主体的横截面形状可以采取各种不同的形状,即圆形,三角形,方形,矩形,正方形,菱形(斜方形),多边形,六边形,八边形,尤其是带有圆角的形状,椭圆形、肾形或者任何自由形式的形状。但是,可以将该形状限定成某些基本形状,因为这会简化制造工艺。所述基本形状中,尤其包括圆形,三角形,方形,矩形,正方形,菱形,六边形,所有有角的、包括那些带圆角的形状,椭圆形以及肾形。
按照本发明的第三方面,本发明想要独立地保护这一方面以及它与其它方面的结合,第二主体借助于压配合或过盈配合容纳在第一主体中。压配合或过盈配合是指,例如,第二主体的外圆周或者压配合或过盈配合接触表面附近的外部尺寸大于第一主体或者固定部件或连接部件的内部尺寸,其中第二主体借助于压配合或过盈配合承接在第一主体或者固定部件或连接部件中。因此,仅通过第二主体和/或第一主体和/或对应连接部件或固定部件的弹性变形就可以实现过盈配合,在压配合情况下则是通过附加的塑性变形实现的。
因此,所述压配合或过盈配合可以通过第一主体与第二主体之间的接触或者连接部件的介入而直接实现。
可选择的是,按照本发明的另一方面,主体和/或连接部件之间的连接可以借助于摩擦连接、材料连接或牢固连接(结构配合)来实现。
尤其是,所述连接部件可以包括固定板和/或连接销。
所述固定板优选形成为垂直于管体纵轴设置的板或环,它们自身也是通过压配合或过盈配合或者螺钉连接或铆钉连接或者通常借助于摩擦连接、材料连接或牢固连接(结构配合)固定在第一主体中。第二主体可以优选为也通过压配合或过盈配合或通过连接销或者通常借助于摩擦连接、材料连接或牢固连接而固定。
也就是说,第二主体,例如可以与连接部件形成一个结构单元,然后借助于压配合或过盈配合将该结构单元总体固定在第一主体中。
连接销可以形成为铆钉,螺钉和/或杆,例如,所述杆可以是焊接的。
为了将第二主体设置在第一主体中,可以提供至少一个,优选数个,尤其是两个固定板。固定板的设置可以优选是位于管状主体末端作为端板或沿着管状主体的长度分布作为中间板。
更精确地说,所述固定板除了具有承接孔以外,优选还具有多个开口,借助于这些开口来承接并固定第二主体。所述多个开口也起到让相邻组织向内生长的作用。
除了固定板以外,或者作为替代固定板的选择,可以提供连接销,所述连接销尤其形成为铆钉,螺钉和/或杆,例如,所述杆是焊接的。
连接销优选具有止动表面用于间隔保持所述主体,例如可以通过对应的铆钉帽或螺钉帽提供止动表面,可以在铆钉与所述帽相对的那一端或者螺纹附近提供第二止动表面。
连接销可以设置在管状主体的护套表面的开口或通孔中,所述开口或通孔是为了与相邻组织紧密结合而提供的,或者,可以提供分离的连接开口,用于将连接部件承接在管状主体或植入物的固定板等其它部件中。
在螺钉连接的情况下,优选的是,螺纹孔平行于管体纵轴设置在第一、外部主体中,使得螺钉的螺帽位于内侧,这样的结果是,提供了一种简单的方式来得到没有突起的光滑外侧。
特别地,按照本发明的另一方面,可以借助于可拆卸连接部件或者在使用点处可以直接附着或连接上去的连接部件,将其中一个至少部分地位于另一个之内的管状主体连接起来,从而形成模块系统。这种模块系统有利于以简单方式实现所需的个体调节。因此,可以提供数个管状主体和对应连接部件的模块系统,其中,外科医生直接在使用点处组合对应的位置支撑器以适合个体需要。显然,位置支撑器也可以是预先制成的。但是,即使如此,也仍然可以在可拆卸连接部件的情况下作出改变。
另外,按照本发明想要独立保护的另一方面,本发明的位置支撑器的特征在于,仅在护套表面上的少数几个位置处和/或前面附近提供管状主体的连接,使得当沿着位置支撑器的全长看过去时,在位置支撑器之间的很宽区域中形成用于组织向内生长的自由空间。尤其是,可以将连接部件限定为总共2至24个、优选2至12个部件,和/或可以将2至4个、尤其是3个连接部件分配给护套表面中的每排开口或通孔。连接部件可以与通孔自身相配合,或者与另外的承接孔、凹陷或螺孔之类的孔相配合。
在另一实施例中,管状主体可以同心设置,使得形成平行壁区,在相同横截面形状的情况下更是如此。
在另一优选实施例中,连接部件可以优选为可变地连接在管状主体的护套表面的开口中,使得管状主体可以相对于彼此任意地排列和布置。例如,所述主体可以设置成其中一个不完全位于另一个之内,而是,例如,让其在纵向上突出在外面。这就意味着位置支撑器的长度或高度可以调节,因为相互嵌套的不同管状位置支撑器可以伸缩地从彼此中缩回,或者相反,可以推入到彼此之中,用于随后使它们固定在该位置上。这可以连续进行或按步骤进行。另外,管状主体也可以彼此逆向旋转,使得护套表面中的开口相对于例如一个或两个相邻主体或所有主体成对准排列或交叉排列。
优选的是,管状主体可以具有不同的形式,尤其是不同的壁厚,例如可以使得外部管状主体非常薄以促使周围组织快速生长在一起或向内生长穿过开口,同时内部管状主体由于具有较大的壁厚因而使位置支撑器具有必需的稳定性。
可以想到的是,可以用于横截面形状的不同形状也可以用于管状主体的护套表面的开口或通孔,因此,它们的外轮廓也可以为如下形状:圆形,三角形,方形,矩形,正方形,六边形,八边形,通常为带有或不带有圆角的多边形,菱形等。
管状主体优选设置成彼此隔开,其间隔可以是由连接管状主体的连接部件提供的,和/或可以是由分离的间隔件提供的,所述间隔件可以特别设置在护套表面的内侧和/或外侧上,优选为朝向所述外侧或内侧成直角突出的杆状或板状。由于管状主体的间隔,就提供了用于组织向内生长的足够空间。此外,由于管状主体的间隔设置,就可以在末端或前面形成相应的宽的接触表面,因此不必使用分离的端板等连接件。
优选的是,管状主体至少在一端、优选在两端具有突起和/或凹陷,所述突起和/或凹陷能够与相邻椎骨或其它组织接合并促进向内生长。
可以由销子、螺栓、钩子、螺钉、端板等形成连接部件,它们可变化地被容纳,特别是容纳在护套表面的开口或通孔处,因此不需要为连接部件设置附加的分离承接孔。这可以减小成本并简化制造工艺。虽然如此,在管状主体的护套表面处可以设有对应的分离承接孔。
在一个优选实施例中,位置支撑器在管状主体的前面处具有至少一个、优选两个端板,所述端板同时用作连接部件。为了这个目的,例如环形的端板具有切口和/或凹陷,管状主体末端处的突起可以牢固地和/或非牢固地接合在所述切口和/或凹陷中。优选的是,环形端板,其作为张紧环或弹簧环,是与分离间隙或狭缝相配合的,使得管状主体的切口或凹陷中的突起通过端板借助于摩擦而固定。
相应地,通常也可以形成中间板或固定板作为张紧环或弹簧环。
可选择的是或者另外,显然也可以借助于焊接尤其是激光焊接等方式,使端板或固定板与管状主体的结合(材料)连接也能应用于其它的连接部件,尤其是设置在护套表面附近的那些部件。
所述管状主体和/或连接部件可以经过涂敷或进行过表面处理。例如,这里要提到的涂敷是羟基磷灰石,或是等离子体处理,例如,如果用钛或钛合金作为材料,所述处理可以得到粗糙的钛表面。
总体上说,具有相应特性的所有合适的生物兼容材料可以用于上述各种部件,例如管状主体和连接部件。优选的是生物兼容性聚合物或金属,例如钛或钛合金,或者也可以是镍钛诺这种镍-钛合金。尤其是,各种部件也可以使用不同的材料。
按照另一方面,位置支撑器以如下方式形成:选择至少两个不同管状主体,准确地说是使它们至少在直径上不同,这些主体设置成其中一个至少部分地位于另一个之内,然后借助于至少一个连接部件将这些主体彼此连接,优选可拆卸连接。在这点上,如果所述连接部件可以相应地用于许多位置,则所述管状主体相对于彼此的设置优选为可以改变。尤其是,管状主体沿着纵轴和在角度排列上可以有不同的设置。
尽管在下面的实施方式中详细说明了本发明的管状主体的结构,但是也可以通过在任何位置切割长度来调节管状主体的长度和/或末端排列。其结果是进一步提高使用的可变性。
此外,所述位置支撑器不但可以在装配之后全体一起经过涂敷或进行表面处理,而且可以在各部件装配之前单独地经过涂敷或进行表面处理。因此,即使是在内侧上设有部件的情况下,例如圆柱形管状主体设置在内侧上的情况,所述主体可以在装配之前经过涂敷或进行表面处理,从而实现完整的涂敷或表面处理。
总体上说,本发明为位置支撑器提供一种模块的、单独使用的系统,其中,对应的位置支撑器因为源于数个管状主体的多壁和结构而具有非常大的表面积,因此,显著地促进向内生长和生长在一起。此外,尽管有非常大的表面积,仍能提供很好的可制造性,尤其是可涂敷性或可表面处理性,从而有利于生长在一起。尤其是,对各个部件即位于不同位置的各个圆柱形管状主体可以采取不同的涂敷。这样就大体上形成了植入物,由于其机械稳定性且同时结合了良好的易于向内生长性,所述植入物尤其适用于椎间盘或位置支撑器,因而成为整形外科手术中最佳的融合部件。
附图说明
从下面结合附图对优选实施例的说明,可以理解本发明的其它优点、特点和特征。附图仅仅是示意性的,在附图中:
图1是本发明位置支撑器的第一实施例;
图2是图1中的位置支撑器的俯视图;
图3是本发明的另一种位置支撑器的三维视图,其中详细示出了护套表面;
图4是图3中的位置支撑器的俯视图;
图5是本发明位置支撑器的第三实施例的三维视图;
图6是图5中的位置支撑器的俯视图;
图7是图5中的位置支撑器没有端板时的立体视图;
图8是图7中的位置支撑器的俯视图;
图9是两个独立管状主体和处于装配状态的位置支撑器的立体视图,以及各个管状主体的俯视图;
图10是本发明位置支撑器的另一实施例的立体图,其中详细示出了护套表面;
图11是本发明位置支撑器的另一实施例的立体视图,其中详细示出了护套表面;
图12是本发明位置支撑器的另一实施例的立体视图和俯视图;
图13具有子图a)至c),分别是本发明的另一种位置支撑器的立体视图、侧视图和俯视图;
图14是本发明位置支撑器的另一实施例的立体视图;
图15是图14所示实施例的位置支撑器为更短的变体时的立体视图;
图16是与图15对应的位置支撑器的俯视图;
图17是本发明位置支撑器的另一实施例的立体视图;
图18是图17所示位置支撑器的俯视图;
图19是本发明位置支撑器的另一实施例的立体视图;
图20是图19所示位置支撑器的俯视图;
图21是本发明位置支撑器的另一实施例的立体视图;
图22是图20所示位置支撑器的俯视图;
图23是本发明位置支撑器的另一实施例的立体视图;
图24是图23所示位置支撑器的俯视图;
图25至图29显示了本发明的管状主体的剖面形状;
图30至图35显示了本发明的管状主体或位置支撑器的护套表面中的通孔或开口的形状;
图36是螺钉连接的立体视图;
图37是图36所示的螺钉连接的剖面图;
图38是作为螺钉的连接销的立体图;
图39是铆钉连接的立体图;
图40是图39所示的铆钉连接的剖面图;
图41是图39和图40所示铆钉处于非铆接状态时的立体视图;
图42是图41所示铆钉处于铆接状态时的立体视图;
图43是示意性侧视图,显示了本发明的位置支撑器的第一使用实例;
图44是另一个示意性侧视图,显示了本发明的位置支撑器的另一个使用实例;
图45是本发明的第三应用实例的侧视图。
具体实施方式
图1是本发明位置支撑器的第一实施例的立体视图,其中,管状主体2,3和4中的一个部分地设置在另一个之内。
具有最大直径的管状主体4容纳较小直径的管状主体2和3。具有第二大直径的管状主体3容纳最小直径的管状主体2。
管状主体2和3设置在管状主体4和3中,它们每一个均在纵轴方向上突出于较大管状主体4和3的边缘5和6之外。
管状主体2,3和4通过销子8彼此连接,所述销子通过压配合可拆卸地插入且贯穿在管状主体4,3,2的切口或孔25中(见图3)。因此,当拆掉所述销子时,通过沿着位置支撑器1的纵轴、彼此相对地相互推动管状主体2,3和4,就能调节位置支撑器1的长度或高度。达到所需的长度或高度时,通过将对应的销子8插入到孔25中,可以让管状主体2,3和4彼此连接并固定在对应位置上。
销子8在其末端可以设有对应的止动装置和/或制动装置,例如钩(未示出),以确保销子8固定在孔25中。此外,其它连接部件,例如带螺孔的螺钉等,也是可以想到的。
管状主体2,3,4在它们的护套表面10上设有多个开口9,在图1所示的实施例中,这些开口为六边形且在横排和纵列上按规则布置,因而在总体上形成为蜂巢结构。由于这种蜂巢结构,就能保证组织的简单向内生长,并同时保证了位置支撑器的稳定性和强度。此外,减小了位置支撑器的重量。由于管状主体2至4的其中一个位于另一个之内的设置方式而形成的多壁结构,提高了稳定性和强度,而且至少在重叠区域中不会妨碍组织向内生长。
图3和图4分别是本发明位置支撑器1的另一实施例的立体视图(图3)和俯视图(图4),其中,相似或相同的部件用同一附图标记表示。
图3和图4中的实施例与图2和图1中的实施例的区别主要在于,管状主体2至4完全容纳在彼此之内,因而管状主体2和3没有突起于管状主体4的上部边缘5之外。
结果,管状主体2至4的边缘5,6,7形成了例如形成相邻椎骨用的共同接触平面。由于三个管状主体2至4的其中一个设置在另一个之内且彼此隔开,这与单个管状主体相比,具有更大的环状接触表面,而不需要提供附加的端板等。
图1至图4的实施例中的管状主体2至4的末端均具有突起杆或突起刺形式的突起11以及凹进12,因而形成整体上起伏的边缘5至7。准确地说,可以在接近一系列开口9的中间位置处,通过垂直于纵轴切断或切割管状主体2至4结构的长度,形成突起11和凹进12。相应地,凹进12的形状包括突起11附近的平行壁部分和与平行壁部分连接的三角形底部。
突起11和凹进12与椎骨或相邻组织等相邻机体部分相接合,并允许与对应的组织长在一起。
此外,图3中的详细视图显示了用于销子8的孔25或承接孔,所述销子用于连接管状主体2,3,4。可以使用螺钉和螺孔来代替销子8和孔25。
在图4中可以看出,同心设置的、其中每一个在图1至图4所示实施例中都形成为圆柱形状的管状主体2至4彼此隔开并由独立的细杆13固定,所述细杆彼此相隔一定的旋转角。在图4所示的实施例中,杆13彼此相隔120°的旋转角。
在用图1和图2的实施例中的位置支撑器进行外科手术时,销子8是可以直接拆卸和/或连接的,与销子8相比,杆13可以例如借助于激光焊接与管状主体2至4进行实体结合连接(材料连接),这样,位置支撑器是预先准备好的。
图5至图8显示了本发明位置支撑器的另一实施例的各个视图,就像图1至图4所示的实施例一样,该位置支撑器也可以特别用作椎骨的位置支撑器。这里,相同或相似的部件也用同一附图标记表示。
图5至图8所示的实施例中,尤其是如图8所示,设有两个管状主体3和4,它们完全设置在彼此之内,即,管状主体3完全容纳在管状主体4中。
图5至图8所示的实施例与图1和图3所示的实施例的区别在于,在每个上端和下端处,设有环形盘状的端板14,所述端板由狭缝或间隙16再划分。此外,数个矩形切口15沿环形布置在端板14中。因此,从图6中的俯视图可以非常明显地看出,切口15容纳管状主体4和3的突起11。
由于狭缝16,环形端板14起到张紧环或弹簧环的作用。例如,当设置有端板时,可以通过将端部17和18挤压在一起来弹性减小所述间隙的宽度。在端板14放置到管状主体3和4上且突起11插入切口15中之后,由于环形端板14释放时的弹性回复力,所述端板松弛,使得突起11被挤压并抵靠于切口15的边缘,因此,端板14非牢固地或通过摩擦抵靠于突起11。
这种支撑方式也可用于固定板,所述固定板不是设置在管状主体的末端处,而是沿着管状主体的长度定位在管状主体两个末端的中间位置处(中间板)。
图7和图8显示了图5和图6中的位置支撑器1没有端板14时的视图。这里可以看出,仅仅用端板使管状主体3和4保持隔开,而不需要附加的连接部件或间隔件。
图9显示了本发明位置支撑器的另一实施例,其中,开始是独立地显示了管状主体3和4,然后在右边的子图中显示了它们的装配状态。除了立体视图以外,在图9的下方显示了管状主体3和4的俯视图。此外,相同或相似的部件也用同一附图标记表示,就像前面的实施例中一样。
尽管外部管状主体4基本对应于前述的实施例,但内部管状主体3还设有板式的间隔件19,所述间隔件在管状主体3的护套表面10上垂直向外突出,形成数排。间隔件19可以与圆柱形主体3一体形成或借助于结合连接、牢固连接或非牢固连接附设在圆柱形主体3上。显然,也可以想到的是,间隔件可以类似地设置在外部管状主体的内侧或设置在两个管状主体上。
各间隔件19按照特定的角度间隔沿着管状主体3的外周面分隔开,更具体地说,在图9所示的实施例中,按照40°的间隔分隔开。显然,可以有更多或更少的间隔件围绕着所述外周面设置或者形成为一排、更多排或更少排,也可以相隔不同的间距。
在所示的实施例中,例如通过相应的制动连接或夹持连接,间隔件19也可以同时用作管状主体4与3之间的连接部件。这一点是可能的,例如,如果在管状主体4的内侧上设置对应的切口,间隔件19可以接合在该切口中。例如,管状主体4的内径尺寸和带有间隔件19的管状主体3的外径尺寸可以设计成带有间隔件19的管状主体3的外径略微大于管状主体4的内径,使得当间隔件19与管状主体4内侧上的对应切口或凹陷(未示出)接合以便同时用作连接部件时,主体3和4中的一个或两个在装配、然后释放的过程中分别弹性扩张或者压缩。
图10和图11显示了本发明位置支撑器的另外实施例,以及在椎间盘或用来替代椎间盘等情况下的应用。这里,相同或相似部件仍用同一附图标记表示。
图10和图11通过护套表面10的放大细节图特别显示出一个设置在另一个之内的管状主体3和4可以不同地排列,具体到一方面上来说,使它们的开口9如图11所示彼此齐平或对准排列,或者如图10所示彼此偏置。在开口9偏置设置时,可以看出,内部管状主体3的外覆护套的杆状区域103位于外部管状主体4的开口9后面,而外部管状主体4的护套表面的杆状区域104部分地盖住管状主体3的开口。
相比之下,在管状主体3和4的开口9齐平对准的情况下,内部管状主体3的护套表面区域103设置在外部管状主体4的护套表面区域104后面,且在护套表面10中形成贯穿开口9。
接下来,在图12中显示了椎骨用的位置支撑器,其基本上对应于前述实施例,因而用同一附图标记表示相同或相似的部件。
在图12的位置支撑器1中,管状主体2至4仍然是其中一个插在另一个之内,其具体特征在于,管状主体2至4具有不同的壁强度或厚度,这一点可以从图12的右侧子图所示的俯视图中更明显地看出。因此,内部管状主体2和外部管状主体4都薄于中间管状主体3。这样,中间管状主体3对强度和稳定性有最大贡献,而外部管状主体4和内部管状主体2由于小的壁厚而促进快速向内生长和生长在一起。这里,为了解释的目的,没有示出销子8或杆13等间隔件。
图13的三个子图a)至c)分别是用于椎间盘的位置支撑器1的立体图(a)、侧视图(b)和俯视图(c)。这里,相同或相似的部件用同一附图标记表示,就像前述实施例一样。
图13的实施例对应于图3所示的位置支撑器1,区别在于,只设置有两个管状主体4和3,且只设有单排的完整成型开口9。因此,相对于图3所示的位置支撑器1,图13所示的位置支撑器1的高度或长度显著减小。这符合不同的使用目的,即,一个是用作椎骨的位置支撑器(图3),另一个是用作椎间盘的位置支撑器(图13)。
图14显示了本发明位置支撑器的另一实施例的立体图,其中,用相同的附图标记表示相同或相似的部件,就像前述实施例中一样。
图14所示的位置支撑器1具有圆柱形管状的第一管状主体4,其设有多个菱形开口9,这些开口按横排和纵列布置,因而形成蜂巢结构。所述菱形开口或通孔由块结构10限定,这些块结构就像前述实施例中一样,在圆柱形管状主体4末端的上部边缘和下部边缘形成突起11和凹陷或凹进12。
在外部管状主体4中设有两个固定板30,它们位于管状主体4的端部区域中。固定板30完全容纳在管状主体4中并通过压配合或过盈配合固定在那里。相应地,选择固定板30的外径使其稍微大于管状主体4的内径,使得这些部件弹性张紧。也可以使用其它合适的部件来固定所述固定板。
圆形盘状的固定板30具有多个开口31,这些开口促进组织的向内生长和穿透。
此外,设置有承接孔32,在所述承接孔中容纳第二圆柱形管状主体3',3″和3′″,所述第二圆柱形管状主体在形状和形式上与外部管状主体4相对应。但是,第二管状主体3',3″和3′″在尺寸上与外部管状主体4不同,即,选择第二管状主体3',3″和3′″的直径使其远小于外部管状主体4的直径。固定板30的承接孔32设置在假想三角形的角位置处,使得第二管状主体3',3″和3′″彼此并排地容纳在外部管状主体4的内部空间中。因此,第二管状主体3',3″和3′″的管体纵轴贯穿第二管状主体3',3″和3′″的圆形横截面中心,并平行于外部管状主体4的中心管体纵轴偏置。
第二管状主体3',3″和3′″也通过压配合或过盈配合容纳在固定板30的承接孔32中。同样,选择第二管状主体3',3″和3′″的外径使其稍微大于承接孔32的直径,使得在将第二管状主体3',3″和3′″插入时,第二管状主体3',3″和3′″以及固定板30发生弹性变形,这样实现管状主体3',3″和3″在承接孔32中的压配合。
尽管图14所示的实施例可以用作椎骨的位置支撑器,但图15中立体视图显示出的变体也用作椎间盘替代物。相应地,在图15中,就像前述实施例中一样用相同的附图标记表示相同或相似的部件,位置支撑器1在长度上要短得多。相应地,只设有单个固定板30,以此代替图14所示实施例中的两个固定板。图15所示实施例中的固定板30设置成近似位于位置支撑器高度的中间位置,即,位于沿着管体纵轴的长度的中间位置。
除了这里所说明的区别以外,图15所示的实施例与图14所示的实施例没有区别,因此不再赘述。
图16显示了图15所示实施例的俯视图,其中清楚地显示了外部管状主体4以及第二内部管状主体3',3″和3′″的设置。此外,显示了设在固定板30中的、让组织向内生长和穿透的开口3l。如图所示,开口31可以具有不同的尺寸。
总的来说,在图14至图16所示的实施例中,提供了一种植入物或位置支撑器,由于所选择的压配合或过盈配合设置方式,其容易制造而且其部件有利于简单的和变化的设置。此外,通过各管状主体的设置而为外部管状主体4提供了让组织向内生长的足够自由空间。同时,也在位置支撑器1末端处提供了用于容纳和分散荷载的足够大的接触表面。
图17至图24显示了不同的实施例,其中,没有使用固定板,仍然通过压配合或过盈配合将不同形状的数个或独立的第二管状主体3容纳在不同形状的外部管状主体4中。
在图17和图18以立体图和俯视图显示的实施例中,外部管状主体4在垂直于管体纵轴即垂直于护套表面的横截面上具有肾形的形状,而容纳在外部管状主体4中的第二管状主体3',3″和3′″具有圆形横截面。相应地,在这里,第二管状主体3',3″和3′″也彼此并排地容纳在外部管状主体4中。
在图19和图20中以立体图和俯视图显示的位置支撑器1的情况下,也通过压配合或过盈配合将两个具有圆形横截面的圆柱形管状主体3'和3″设在具有椭圆形横截面的外部管状主体4中,而在图21和图22所示的实施例中,将三个圆柱形管状即具有圆形横截面的第二主体3',3″和3′″设置在圆柱形管状即也具有圆形横截面的外部管状主体4中。
在图23和图24中显示了本发明位置支撑器1的另一实施例,其中,只有两个管状主体一个设置在另一个之内。在图23和图24所示的实施例中,内部管状主体3在垂直于管体纵轴的横截面上具有三角形状,而外部管状主体4为具有圆形横截面的圆柱形管状。因此,在图23和图24所示的实施例中,只有一个管状主体3通过压配合或过盈配合容纳在管状主体4中。
在图17至图24的实施例所示的变体中,如下方案也是可以的:取代压配合或过盈配合,借助于螺钉形式的连接销等连接部件,或焊接之类的结合连接,使第一和第二管状主体4和3在接触表面处连接。
图25至图29显示了可以用于本发明的管状主体2,3,4的不同剖面形式。除了例如在图25中示出的圆形或环形横截面以外,也可以想到方形尤其是矩形且优选为正方形(图26)、六边形(图27)、椭圆形(图28)或肾形(图29)。此外,也可能使用其它的形状,例如八边形基本形状或总体上自由形式的形状。但优选的是,采取简单基本形状。尤其是,也可以让具有不同横截面形状的柱形管状主体彼此结合。
图30至图35显示了开口9的不同形状以及它们在管状主体2至4的护套表面10中的相互排列。除了图30所示的菱形(斜方形)以外,也可以想到圆形(图31)、方形尤其是正方形和矩形(图32)、六边形(图33)、椭圆形(图34)或八边形(图35)。此外,也可以想到其它合适的形状,只要它们有利于形成大面积的开口9且同时有利于嵌套结构的稳定性。
关于上述关于开口9的相互排列,可以象例如图32和图35所示的那样,这些开口按排布置,其中开口9总体上按排隔开,也可以象图30和图33中具体显示的那样,这些开口按排布置,并突起到相邻排的对应空隙中。
图中也显示出,在纵列方向上排列的开口9可以正好位于彼此下方,优选是相对于彼此偏置,以使轴向荷载分散特别得以改善。如图30至图35进一步示出的,开口9呈上下设置的那些列都是偏置的,基本上是彼此偏置一个开口的半个宽度。
图36至图42显示了借助于铆钉连接和螺钉连接等连接销进行连接的实施例的不同视图。
图36显示了护套表面或者形成管状主体3和4的护套表面10的块结构10的局部视图,其中提供了螺钉连接。螺钉13具有螺帽40,如图37中的剖面图所示,所述螺帽有一个接触表面43与管状主体3的内表面接触,而螺钉13的轴杆45突起穿过管状主体3的壁中的开口,其与螺帽40相对的螺纹端41与外部管状主体4的螺孔42配合。以这种连接方式,用于限定螺纹端41的接触表面44与外部管状主体4的内侧接触。设计螺钉连接优选使得管状主体4的外侧与螺钉13的螺纹侧端齐平。
图38显示了螺钉13的立体视图。虽然没有示出,螺帽也可以设置成与螺丝刀等致动工具相配合。
类似于螺钉连接的视图,图39至图42显示了铆钉连接。这里,铆钉连接也用于管状主体3与4之间的连接,这尤其可以从图39所示的立体视图中清楚地看出。从图40中可以看出,铆钉50的帽部在其接触表面56处接触管状主体3的内侧,同时,在铆钉50与帽部51相对的那一端,用于限定铆钉小段的接触表面57与外部管状主体4的内侧接触。每个管状主体3和4具有一个透孔式开口,铆钉50的铆钉轴杆52插在该透孔式开口中。铆接区域53具有圆柱形状的切口55,使得在铆钉50插入管状主体4的透孔式开口之后,边缘54可以卷起,因此提供可靠的连接,并防止铆钉脱离管状主体4的透孔式开口。
图41和图42分别显示了处于非铆接状态的铆钉50(图41)和处于铆接状态、带有边缘54的铆钉50(图42)。
图43和图44是示意性侧视剖视图,显示了本发明的位置支撑器的应用,图43所示的位置支撑器1用作椎间盘替代物,图44所示的位置支撑器1用于椎骨替代物。
图43和图44所示应用中的位置支撑器1都是脊柱稳定系统的一部分,在脊柱稳定系统中,椎弓根螺钉20尤其是多轴螺钉设置在椎骨中,所述椎弓根螺钉之间容纳连接杆21以相互排列并稳定脊骨。
由于脊骨中的上述排列,用于脊骨或椎间盘的位置支撑器1要承受特定的应力,尤其是动态应力。本发明的位置支撑器,具体是指其多壁结构或多构件结构,提供了一种用于应对上述应力的解决方案。
此外,本发明的位置支撑器也可以用于临床应用,例如图45所示的长骨或股骨折断后的情形,其中,在骨头22的中心区域发生损坏的情况下,本发明的相应的位置支撑器1的设置以及带有钉子23和螺钉24的稳定系统可用来再造骨结构。
按照本发明的另一方面,提供一种用于植入人体或动物体内的位置支撑器的制造方法,其包括如下步骤:将第二管状主体至少部分地插入第一管状主体之内,所述第二管状主体在其表面上具有多个开口,所述第一管状主体在其表面上具有多个开口;以及通过至少一个连接部件使所述第一管状主体和所述第二管状主体以相互隔开的结构连接。
按照本发明的另一方面,提供一种用于植入人体或动物体内的位置支撑器的制造方法,其包括如下步骤:将多个内部管状主体至少部分地插入外部管状主体之内,所述内部管状主体在它们的表面上具有多个开口,所述外部管状主体在其表面上具有多个开口;以及将所述内部管状主体设置在所述外部管状主体之内,所述内部管状主体彼此并排地容纳在所述外部管状主体中。
按照本发明的另一方面,提供一种用于植入人体或动物体内的位置支撑器的制造方法,其包括如下步骤:将第二管状主体至少部分地插入第一管状主体之内,所述第一管状主体在其表面上具有多个开口,所述第二管状主体在其表面上具有多个开口;以及将所述第二管状主体设置在所述第一管状主体之内,所述第二管状主体和所述第一管状主体借助于压配合或过盈配合相连接。
在前述的制造方法中,还包括:将第一尺寸的管状主体切割成第一长度,形成第一管状主体,将第二尺寸的管状主体切割成第二长度,形成至少一个第二管状主体。
在前述的制造方法中,还包括:对第一管状主体和第二管状主体进行表面处理。
本发明还提供一种植入人体或动物体内的模块位置支撑器系统,其包括第一、第二和第三管状主体,其中每个管状主体具有护套表面而且在其护套表面上具有多个开口,每个第一、第二和第三管状主体相对于其它管状主体具有不同的尺寸或形状。优选的是,第一和第二管状主体固定成其中一个位于另一个之内,形成第一位置支撑器;可选择的是,第一和第三管状主体固定成其中一个位于另一个之内,形成第二位置支撑器。
Claims (19)
1.一种植入人体或动物体内的位置支撑器,所述位置支撑器包括:
第一管状主体,其具有带有多个开口的护套表面,所述开口用于让相邻组织向内生长;
至少一个第二管状主体,其具有带有多个开口的护套表面,所述第二管状主体设置成位于所述第一管状主体之内,且所述第一管状主体和所述第二管状主体的端部对准以形成多壁的位置支撑器,
其特征在于,
借助于压配合或过盈配合,将所述第二管状主体直接设置或者通过一个或多个连接部件设置在所述第一管状主体中,其中,所述第二管状主体的外周边大于所述第一管状主体的内部尺寸或大于借助于压配合或过盈配合承接所述第二管状主体的所述连接部件的内部尺寸。
2.如权利要求1所述的位置支撑器,其中,
在垂直于管体纵轴的截面上,所述第二管状主体的横截面形状不同于所述第一管状主体的横截面形状。
3.如前面任一项权利要求所述的位置支撑器,其中,
所述第一管状主体和所述第二管状主体具有不同的壁厚,和/或所述第一管状主体和所述第二管状主体的横截面形状包括多边形和带圆角的形状,其中所述多边形包括三角形,方形,菱形,斜方形,六边形和八边形,所述方形包括矩形,所述矩形包括正方形,且所述带圆角的形状包括圆形、椭圆形和肾形。
4.如权利要求1所述的位置支撑器,其中,
所述第一管状主体具有圆形横截面形状,所述第二管状主体具有三角形、方形、六边形、八边形、椭圆形或肾形的横截面形状;或者所述第一管状主体具有椭圆形或肾形的横截面形状,所述第二管状主体具有多边形、椭圆形或肾形的横截面形状,所述多边形包括三角形、方形、六边形和八边形。
5.如权利要求1所述的位置支撑器,其中,
所述第二管状主体与所述第一管状主体隔开一定距离,和/或所述第二管状主体彼此隔开。
6.如权利要求1所述的位置支撑器,其中,
在所述第一管状主体中容纳有两个、三个或更多个第二管状主体和/或至少两个第二管状主体彼此并排地容纳在所述第一管状主体中。
7.如权利要求1所述的位置支撑器,其中,
所述第二管状主体设置成使得它们的管体纵轴平行于所述第一管状主体的管体纵轴偏置。
8.如权利要求1所述的位置支撑器,其中,
所述第一管状主体和所述第二管状主体同心设置。
9.如权利要求1所述的位置支撑器,其中,
所述位置支撑器具有用于连接所述第一管状主体和所述第二管状主体的连接部件,所述连接部件包括固定板。
10.如权利要求1所述的位置支撑器,其中,
设有至少一个固定板,所述固定板(30)具有承接孔(32),所述承接孔通过压配合或过盈配合容纳或固定所述至少一个第二管状主体。
11.如权利要求9或10所述的位置支撑器,其中,
所述固定板(30)作为端板设置在所述第一管状主体的端部区域中,或者作为中间板沿着所述第一管状主体的长度分布,和/或所述固定板(30)具有多个开口(31)。
12.如权利要求9所述的位置支撑器,其中,
通过非牢固连接、摩擦连接、结合连接、材料连接、牢固连接或结构配合连接,来将所述固定板支撑在所述第一管状主体中。
13.如权利要求9所述的位置支撑器,其中,通过过盈配合或压配合或者通过螺钉连接或铆钉连接,来将所述固定板支撑在所述第一管状主体中。
14.如权利要求1所述的位置支撑器,其中,
相对于相邻或所有管状主体,至少部分设置的所述第一管状主体和所述第二管状主体的所述开口以齐平或偏置方式排列,和/或所述第一管状主体和所述第二管状主体的所述开口规则设置,和/或按照包括排和列的线设置,和/或具有如下外轮廓:多边形或带圆角的形状,其中所述多边形包括三角形,方形,菱形,斜方形,六边形和八边形,所述方形包括矩形,所述矩形包括正方形,且所述带圆角的形状包括圆形和椭圆形。
15.如权利要求1所述的位置支撑器,其中,
所述第一管状主体和所述第二管状主体具有端部突起(11)和/或凹陷。
16.如权利要求1所述的位置支撑器,其中,
所述第一管状主体和所述第二管状主体和/或连接部件经过表面处理,所述表面处理包括涂覆。
17.一种模块系统,其包括:
多个管状主体(2,3,4),它们用于形成权利要求1至16中任一项所述的位置支撑器,每个管状主体在其护套表面(10)处具有多个开口(9),并具有不同的尺寸,使得至少两个不同的管状主体可以设置成其中一个至少部分地位于另一个之内;以及
用于连接所述多个管状主体的连接部件(8,13,14),所述多个管状主体用于形成权利要求1至16中任一项所述的位置支撑器。
18.如权利要求1至16中任一项所述的位置支撑器的制造方法,其中包括如下步骤:
选择至少两个不同的管状主体(2,3,4);
所述至少两个不同的管状主体设置成其中一个至少部分地位于另一个之内;以及
所述至少两个不同的管状主体中的至少两个彼此连接。
19.如权利要求18所述的方法,其中,
在使用者指定的那一侧通过切割来调节所述至少两个不同的管状主体(2,3,4)的长度和/或其末端的排列情况。
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2005
- 2005-12-23 DE DE102005061932A patent/DE102005061932A1/de not_active Ceased
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2006
- 2006-05-23 DE DE102006024168A patent/DE102006024168A1/de not_active Withdrawn
- 2006-12-15 TW TW099114491A patent/TWI355258B/zh not_active IP Right Cessation
- 2006-12-15 TW TW095147215A patent/TWI348363B/zh not_active IP Right Cessation
- 2006-12-21 KR KR1020060132070A patent/KR101317967B1/ko not_active IP Right Cessation
- 2006-12-22 JP JP2006345652A patent/JP5049583B2/ja active Active
- 2006-12-22 ES ES08167631.4T patent/ES2541549T3/es active Active
- 2006-12-22 EP EP20080167631 patent/EP2033600B1/en active Active
- 2006-12-22 US US11/645,228 patent/US20070179610A1/en not_active Abandoned
- 2006-12-22 EP EP08167635.5A patent/EP2033601B1/en active Active
- 2006-12-22 EP EP06127180.5A patent/EP1800627B1/en active Active
- 2006-12-22 EP EP08167619.9A patent/EP2039327B1/en active Active
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- 2006-12-25 CN CN201210570791.2A patent/CN103054661B/zh active Active
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