CN1154442C - 带锁紧元件的外科空心铆钉 - Google Patents

带锁紧元件的外科空心铆钉 Download PDF

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CN1154442C
CN1154442C CNB998068411A CN99806841A CN1154442C CN 1154442 C CN1154442 C CN 1154442C CN B998068411 A CNB998068411 A CN B998068411A CN 99806841 A CN99806841 A CN 99806841A CN 1154442 C CN1154442 C CN 1154442C
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tubular rivet
locking element
section
locking
rivet
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���ء����߸�
罗伯特·弗里格
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AO Technology AG
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    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
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    • F16B—DEVICES FOR FASTENING OR SECURING CONSTRUCTIONAL ELEMENTS OR MACHINE PARTS TOGETHER, e.g. NAILS, BOLTS, CIRCLIPS, CLAMPS, CLIPS OR WEDGES; JOINTS OR JOINTING
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Abstract

本发明涉及用于在骨头中或骨头上固定外科植入体、丝线或组织的装置，它包括一空心铆钉(1)和一锁紧元件(2)。上述锁紧元件(2)至少在其长度的与其后端(12)相邻的部分(7)上有一多边形横截面(5)，此横截面(5)在此部分(7)上沿纵向轴线(3)朝后端(12)方向变大。当锁紧空心铆钉(1)时，后者可分割成单独的固定舌(13)。上述固定舌(13)可用锁紧元件(2)相对于纵向轴线(3)张开并形成空心铆钉(1)的锁紧头(14)。空心铆钉(1)中的通孔在锁紧部分(9)处有一多边形横截面。

Description

带锁紧元件的外科空心铆钉
本发明涉及一种用于在骨头中或骨头上固定外科植入体、丝线或组织的装置。
从非医学领域已经知道有空心铆钉，其锁紧头由单独的、能较远地张开的舌组成。这种空心铆钉已经例如从美国的Wright的专利4696610和美国的Francis的专利4580936知道。这些已知的空心铆钉有纵向的裂缝或切口，它们使之有可能在锁紧空心铆钉时形成由单独的舌组成的锁紧头。如此构成的锁紧头有大的支承面。这种已知的空心铆钉的缺点为，锁紧头通过纵向舌的弯曲形成，因而舌的端部不能作为锐利的尖角压入锁紧头侧的要连接的材料中，这样将不大可能阻止空心铆钉在要连接的材料的孔中转动。
从英国的Tucker Fasteners的专利2054082知道其它一种非医学空心铆钉，不过，它有一个圆的通孔，以致它不能防止转动。
本发明在此处将作出补救。本发明以这样的目的为基础，即建立一个固定系统，它可以通过一个小孔插入，并在固定以后，由于张开的固定舌而在骨头的内表面上有宽的支承，此时，固定舌可埋入骨头的内表面中，并由此防止空心铆钉转动。
在医学领域中，在骨折处理中，在采用现在的骨螺钉的地方，几乎可以到处使用按照本发明的固定元件，特别是：
—在有一部分只有很薄的皮质的多孔性骨头中，按照本发明的固定元件可用于板的固定，以代替螺钉；
—在骨松质中，按照本发明的固定元件可作为用于板或缝合线的锚固件或用于重新装设肌腱和韧带。在空心铆钉的锁紧头张开时形成的爪突出地固定在骨松质的小梁结构中；以及
—在如同股骨头或肱骨头这样的关节头中，按照本发明的固定元件可以作为一侧板或一骨髓内的支承件的锚固件来应用。目前都用大螺钉固定纵向支承。不过，这种螺钉在关节头的多孔性骨头中不能有最佳的固定。
类似的系统为具有可释放的爪的螺钉，髓内钉或髋部螺钉，例如用于肱骨的Seidel髓内钉。这种髓内钉在钉尖上有裂缝，后者通过一具有球形头的中心销张开，由此，舌成翼状向外弯曲。不过，这些舌只能略离钉子弯曲。
在这些已知的固定工具中，其缺点为，植入体用这些已知的固定工具在多孔性骨头中的固定至今并未解决。植入体常常只能通过将骨胶注射入骨头中而固定。这是非常成问题的，因为骨头在骨胶(Knochenzement)硬化时通过所产生的热受到损伤。此外，骨胶不再能被去掉，而这在可能产生感染时又是必需的。
这种已知的固定工具的另一缺点在于，例如一个螺钉的把持力是通过其直径给定的。在轴向过载时，将会撕出一个等于螺钉直径的骨圆柱。骨螺钉的把持力在健康的骨头中是足够的。但是在骨质疏松时，在关节区域在薄的壳状骨头中，螺钉固定常常是不够的，由于地方的原因，较大的螺钉无法应用，或者还进一步损坏还存在的骨头。
本发明在此处将作出补救。本发明另一方面以这样的目的为基础，即建立一个固定系统，它通过一个小孔插入，并在固定以后，由于张开的固定舌而在骨头的内表面上有宽的支承。
为实现上述目的，本发明提供一种用于在骨头中或骨头上固定外科植入体、丝线或组织的装置，其中：A)所述装置包括一具有纵向轴线和一共轴线的通孔的空心铆钉，以及一具有一后端和一前端的锁紧元件；B)锁紧元件至少在与其后端相邻的部段上有一多边形横截面，并且在这一部段上，横截面沿纵向轴线朝后端变大；C)在锁紧空心铆钉时，空心铆钉可通过压入锁紧元件在该空心铆钉的要锁紧的部分上分裂成单独的固定舌；以及D)固定舌可借助锁紧元件相对于纵向轴线张开，并形成空心铆钉的锁紧头，E)空心铆钉中的通孔在锁紧部分处有一多边形横截面，其特征为，F)在铆钉杆中或在其上，在多边形横截面的角部上设置预定断裂部位。
空心铆钉中的通孔在锁紧部分处有一多边形横截面，它最好为正方形，但是也可以是三角形、五边形、六边形或多边形。
按照本发明的用于在骨头内或骨头上固定外科植入体、手术线或组织的装置的一个优选的实施形式由一具有一纵向轴线和一共轴线的通孔的空心铆钉，以及一个可插在通孔中的锁紧元件组成。该锁紧元件至少在其长度的与其后端相邻的部段上有一多边形横截面，其中，在其长度的这一部段上，横截面沿纵向轴线朝锁紧元件的后端变大。锁紧元件将如此插入空心铆钉中，即使得锁紧元件的锥形部分的较小的横截面首先如此深地插入空心铆钉，直至它由于最大的横截面而靠在空心铆钉的通孔中。当通过进一步将锁紧元件压入空心铆钉的通孔中而锁紧空心铆钉时，该空心铆钉将在要锁紧的部分上通过锁紧元件的变得更大的多边形部分被分裂成单独的固定舌，该固定舌以后通过锁紧元件的变得更大的部分张开成半圆形并形成一固定在一大面积上的由许多固定舌形成的锁紧头。固定舌的数目此时对应于锁紧元件的多边形横截面的边数。
相对于前述实施形式而言，按照本发明的装置的另一实施形式的出众之处在于，锁紧元件至少在其长度的与其后端相邻的部段上有一正方形横截面。具有较少的边数的横截面的优点在于以此为基础形成的较锐利的边缘，由此，在锁紧空心铆钉时，有利于将铆钉杆分裂成单独的固定舌。
相对于前述实施形式而言，按照本发明的装置的另一实施形式的出众之处在于，锁紧元件的横截面至少在长度的与其后端相邻的部段上，沿着长度，朝锁紧元件的后端按锥形变大，此时，锥角要如此选择，以使既有利于将铆钉杆分裂成单独的固定舌，又有利于在锁紧空心铆钉时，扩大这些固定舌。
相对于前述实施形式而言，按照本发明的装置的另一实施形式的出众之处在于，空心铆钉中的通孔在锁紧部分有一正方形截面，并且在铆钉杆上在角部设置预定断裂部位，由此，在锁紧空心铆钉时，有利于将铆钉杆分裂成单独的固定舌。有利的是，预定断裂部位有一为空心铆钉直径的1％～10％，最好为5％～9％的壁厚。
相对于前述实施形式而言，按照本发明的装置的另一实施形式的出众之处在于，锁紧元件可拆地与锁紧销连接。
再有，按照本发明的装置的另一实施形式与前述实施形式的区别在于，至少一个锁紧元件是髓内钉的一部分。
再有，按照本发明的装置的另一实施形式与前述实施形式的区别在于，空心铆钉有一可拆的铆钉头。为此，可拆的铆钉头设有内螺纹，后者可拧在空心铆钉的相应的外螺纹上。如果将空心铆钉作为锚固件来使用，例如和一侧板或一髓内钉一起作为在股骨头上的固定工具来使用或作为缝合线锚固件来使用，则适用无铆钉头的空心铆钉结构。此时，无铆钉头的空心铆钉结构有这样的优点，即在张开过程中可较深地进入骨头中。这种“后滑动”在阻止空心铆钉张开时切穿骨松质。
再有，按照本发明的装置的另一实施形式与前述实施形式的区别在于，在锁紧元件的后端装上一钻头，由此，可以省去骨头的预钻孔。
再有，按照本发明的装置的另一实施形式与前述实施形式的区别在于，空心铆钉中的通孔在其长度上的与要锁紧的部分相对的部段上设有内螺纹，后者使之有可能例如将另一植入体或植入体部分拧入安装好的空心铆钉中。
再有，按照本发明的装置的另一实施形式与前述实施形式的区别在于，锁紧元件的锁紧销可以弹性地弯曲。由此，有可能将空心铆钉装在例如股骨头上，其中，锁紧销可通过整个股骨拉过。
还有，按照本发明的装置的另一实施形式的出众之处在于，在空心铆钉的要锁紧的部分上的壁厚S为空心铆钉的直径D的1％～20％。由此，使之有可能用锁紧元件上的多边形锥体将铆钉杆简单地张开成单独的固定元件。
还有，按照本发明的装置的另一实施形式的出众之处在于，固定舌可用锁紧元件相对于纵向轴线成半圆形张开，并形成空心铆钉的锁紧头。由此，例如在骨头内表面上得到一宽的支承，而且，由于通过按半圆形形成固定舌，固定舌在骨头表面上的几乎垂直地站立的端部就形成锁紧头的爪状固定件。
再有，相对于前述实施形式，按照本发明的装置的另一实施形式的特点在于，该空心铆钉由一可塑性弯曲的材料，刚如由纯钛，钛合金或者由用于植入物的钢制成，由此更容易形成上述半圆形的固定舌。
相对于前述实施形式而言，按照本发明的装置的另一实施形式的出众之处在于，在锁紧头的两个彼此相对的固定舌的两个相对的端部之间包括一长度L，它相当于空心铆钉的直径D的2倍至3倍。固定舌的这一大的扩展再次在骨头的内表面上产生一宽的支承。
通过本发明得到的优点可基本上在此处看到，即由于按照本发明的装置，只需要在骨头上钻一个小洞，而按照本发明的空心铆钉在安装以后在骨头内表面上有宽的支承。此外，例如与在髋部螺钉的情况不同，通过固定舌的半圆形锚形构造和其在骨头中的固定，可防止固定元件的头部转动。此外，在多孔性骨头中，关节头的骨松质(Spongiosa)，如果完全存在的话，在力学上是不能受载的。易言之，髋部螺钉位于空腔中，就会造成股骨头相对于髋部螺钉的位错。只有当髋部螺钉与骨头内表面接触时，髋部螺钉才能承担其职能。由于在此情况下，螺钉与骨头之间的界面常常是不够的，因此产生螺钉穿入髋关节。在按照本发明的具有半圆形固定舌的空心铆钉中，将主要用骨头的内表面作为植入体与骨头之间的界面。通过固定舌的与解剖学结构良好地吻合的形状，与骨头的接触面积更大以及可以更佳地吻合。如果将按照本发明的空心铆钉用于将髓内钉固定在股骨头上，则测得用于接纳按照本发明的空心铆钉的孔只有8mm左右。这有这样的优点，即与现有的髓内钉-髋部螺钉系统相比，髓内钉的直径可大大地减小。
下面将参考若干实施例的一部分示意图更详细地说明本发明和本发明的改进。
在图中：
图1示出了通过按照本发明的空心铆钉的一个实施形式和按照本发明的锁紧元件的一个实施形式的纵向剖面；
图2示出了通过按照本发明的空心铆钉的一个实施形式和按照本发明的锁紧元件的另一实施形式的纵向剖面；
图3示出了通过图2所示的按照本发明的锁紧元件的实施形式的横剖面；
图4示出了具有一骨板和一骨块的已经锁紧的按照本发明的空心铆钉的实施形式的纵向剖面；
图5示出了图4所示的已经锁紧的按照本发明的空心铆钉的实施形式的一个视图；
图6示出了通过按照本发明的空心铆钉的另一实施形式的纵向剖面；
图7示出了图6所示的按照本发明的空心铆钉的实施形式的正视图；
图8示出了通过按照本发明的空心铆钉的另一实施形式的纵向剖面；
图9示出了通过按照本发明的空心铆钉的另一实施形式和按照本发明的锁紧元件的另一实施形式的纵向剖面；
图10示出了图9所示的具有图9所示的按照本发明的锁紧元件的按照本发明的空心铆钉的实施形式的正视图；以及
图11示出了通过具有按照本发明的空心铆钉、髓内钉和安装套筒的股骨的纵向剖面。
在图1中示出了按照符合本发明的装置的实施形式的空心铆钉1和锁紧元件2。空心铆钉1有一纵向轴线3并由一平行于纵向轴线3延伸的圆柱形铆钉杆8、一与铆钉杆8固定地连接的铆钉头19和一沿纵向轴线3与空心铆钉1共轴线地贯穿的通孔4组成，铆钉杆8不一定必须是圆柱形的。铆钉杆8有一外径D，以使通过通孔4的宽度和外径D所限定的壁厚尺寸要如此确定，即当用锁紧元件2锁紧空心铆钉1时，空心铆钉1可在要锁紧的部分9上分割成单独的固定舌13(图4和5)，此时，固定舌13的数目对应于锁紧元件2的多边形横截面5的边数(图3)。在此处所示的空心铆钉1的实施形式中，铆钉杆8的壁厚S相当于外径D的14％。在图1所示的按照本发明的装置的实施形式中，锁紧元件2是锁紧销16的组成部分。锁紧元件2在其长度的与其后端12相邻的部段上，有一多边的、朝后端12变大的横截面5(图3)。空心铆钉1的锁紧在插入锁紧元件2之后进行，后者用作用在锁紧销16上的拉力压入空心铆钉1的要锁紧的部分9中。在压入锁紧元件2的变大的多边形部段7时，铆钉杆8的壁被张开并通过多边形横截面5的边(图3)被分割成固定舌13(图4和5)。锁紧销16可借助一预定断裂部位与锁紧元件2连接，由此，锁紧销16可在空心铆钉1锁紧以后例如通过施加扭转力而与锁紧元件2分离。
在图2中所示的按照本发明的装置的实施形式与图1中所示的实施形式的差别只在于，锁紧元件2有一与纵向轴线3共轴线地延伸的内螺纹24，而锁紧销17则有一相应的外螺纹23，由此，作为单独的元件构成的锁紧销17可可拆地拧入锁紧元件2中。在空心铆钉1锁紧以后，锁紧销17可从锁紧元件2中拧出，由此可与已经锁紧的空心铆钉1分离。
图3示出了垂直于纵向轴线、通过锁紧元件2的剖面。在此处示出的按照本发明的装置的实施形式中，多边形横截面5由一正方形横截面6组成，由此，在锁紧空心铆钉1时形成四个固定舌13。同样在图3中示出了按照图2所示的按照本发明的装置的实施形式的锁紧元件2的内螺纹24。
图4示出了通过按照符合本发明的装置的一个实施形式的已经锁紧的空心铆钉1的纵向剖面。空心铆钉1将骨板25与一骨头26连在一起。锁紧头14包括四个固定舌13，其端部31形成长度L。从此图还可看出，被固定舌13的端部31包围形成的长度L差不多相当于铆钉杆8的直径D的3倍。图4中所示的已经锁紧的具有四个固定舌13的空心铆钉1的一个视图示于图5中。
在图6和7中所示的按照符合本发明的装置的另一实施形式的空心铆钉1与图1所示的实施形式的差别只在于，通孔4在空心铆钉1的远离铆钉头19的锁紧部分9上做成正方形的。通孔4的角部15在通孔4与铆钉杆8的外径D之间形成预定断裂部位，在该处，铆钉杆8在空心铆钉1锁紧时分割成固定舌13(图4和5)。在空心铆钉1的与铆钉头19相邻的部段上，通孔4按照此处所示的符合本发明的装置的实施形式，与纵向轴线3共轴线地设置内螺纹22。
图8中所示的按照符合本发明的装置的另一实施形式的空心铆钉1与图1～7所示的实施形式的差别只在于，铆钉头20可拆地与空心铆钉1的铆钉杆8连接。铆钉头20与铆钉杆8的这一可拆的连接通过螺纹连接实施。为此，铆钉杆8设有与纵向轴线3共轴线地延伸的外螺纹27，而铆钉头20则设有相应的内螺纹28。
图9和10示出按照本发明的装置的另一实施形式。同样做成圆柱形的空心铆钉1没有铆钉头，并由一具有纵向轴线3的铆钉杆8和一与纵向轴线3共轴线的、同样是圆柱形的通孔4组成。锁紧元件2与图1所示的锁紧元件2的差别只在于，锁紧元件2的后端12设有钻孔元件21。钻孔元件21的直径d对应于空心铆钉1的外径D，以致在安装空心铆钉1时，骨头26(图4)不需要预先钻孔。当然也可以用一个麻花钻，以代替图9和10所示的扁钻21。
图11示出了将按照符合本发明的装置的一个实施形式的空心铆钉1用于将一髓内钉18闩在例如一股骨29中。通过插入空心铆钉1，髓内钉18沿轴向沿近身体中心线方向被固定。锁紧元件2在髓内钉18的远身体中心端32作为髓内钉18的组成部分装上。为了安装空心铆钉1，它被夹在锁紧元件2和一套筒30之间并与髓内钉18一起插入股骨29中。通过在髓内钉18上沿近身体中心线方向施加一拉力和在套筒30上施加一相反的把持力，则空心铆钉1上的锁紧头14就变形并闩住空心铆钉1。

Claims (19)

1.用于在骨头中或骨头上固定外科植入体、丝线或组织的装置，其中：
A)所述装置包括一具有纵向轴线(3)和一共轴线的通孔(4)的空心铆钉(1)，以及一具有一后端(12)和一前端(32)的锁紧元件(2)；
B)锁紧元件(2)至少在与其后端(12)相邻的部段(7)上有一多边形横截面(5)，并且在这一部段(7)上，横截面(5)沿纵向轴线(3)朝后端(12)变大；
C)在锁紧空心铆钉(1)时，空心铆钉可通过压入锁紧元件(2)在该空心铆钉(1)的要锁紧的部分(9)上分裂成单独的固定舌(13)；以及
D)固定舌(13)可借助锁紧元件(2)相对于纵向轴线(3)张开，并形成空心铆钉(1)的锁紧头(14)，
E)空心铆钉(1)中的通孔(4)在锁紧部分(9)处有一多边形横截面，其特征为，
F)在铆钉杆(8)中或在其上，在多边形横截面的角部(15)上设置预定断裂部位。
2.如权利要求1的装置，其特征为，锁紧元件(2)至少在与后端(12)相邻的部段(7)上有一正方形横截面(6)。
3.如权利要求1或2的任一项的装置，其特征为，锁紧元件(2)的横截面(5)至少在与后端(12)相邻的部段上沿纵向轴线(3)朝锁紧元件(2)的后端按锥形变大。
4.如权利要求1或2的任一项的装置，其特征为，锁紧元件(2)为一锁紧销(16)的组成部分。
5.如权利要求1或2的任一项的装置，其特征为，锁紧元件(2)可拆地与一锁紧销(17)连接。
6.如权利要求1或2的任一项的装置，其特征为，至少一个锁紧元件(2)是髓内钉(18)的一部分。
7.如权利要求1或2的任一项的装置，其特征为，空心铆钉(1)有一固定的铆钉头(19)。
8.如权利要求1或2的任一项的装置，其特征为，空心铆钉(1)有一可拆的铆钉头(20)。
9.如权利要求8的装置，其特征为，可拆的铆钉头(20)有一内螺纹(28)，而空心铆钉(1)则有相应的外螺纹(27)。
10.如权利要求1或2的任一项的装置，其特征为，在锁紧元件(2)的后端(12)上安装一钻头(21)。
11.如权利要求1或2的任一项的装置，其特征为，空心铆钉(1)中的通孔(4)在与要锁紧的部分(9)相对的部段上设有内螺纹(22)。
12.如权利要求1或2的任一项的装置，其特征为，锁紧元件(2)的锁紧销(16、17)可按弯曲变形。
13.如权利要求1或2的任一项的装置，其特征为，锁紧元件(2)的锁紧销(16、17)可弹性弯曲。
14.如权利要求1或2的任一项的装置，其特征为，在空心铆钉(1)的要锁紧的部分(9)上，壁厚S为空心铆钉(1)的外径D的1％～20％。
15.如权利要求1或2的任一项的装置，其特征为，固定舌(13)可借助锁紧元件(2)相对于纵向轴线(3)成半圆形张开，并形成空心铆钉(1)的锁紧头(14)。
16.如权利要求1或2的任一项的装置，其特征为，预定断裂部位有一为空心铆钉(1)的外径D的1％～10％的壁厚。
17.如权利要求1或2的任一项的装置，其特征为，预定断裂部位有一为空心铆钉(1)的外径D的5％～9％的壁厚。
18.如权利要求1或2的任一项的装置，其特征为，在锁紧头(14)的两个相对的端部(31)之间包围一长度L，这个长度相当于空心铆钉(1)的直径D的2倍至3倍。
19.如权利要求1或2的任一项的装置，其特征为，在空心铆钉(1)的要锁紧的部分(9)处，壁厚朝铆钉头(19、20)方向变厚。
CNB998068411A 1998-06-04 1999-05-11 带锁紧元件的外科空心铆钉 Expired - Fee Related CN1154442C (zh)

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AU3592799A (en) 1999-12-20
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