CN1622790A - 螺钉锚定的关节假体 - Google Patents

螺钉锚定的关节假体 Download PDF

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Publication number
CN1622790A
CN1622790A CNA018178472A CN01817847A CN1622790A CN 1622790 A CN1622790 A CN 1622790A CN A018178472 A CNA018178472 A CN A018178472A CN 01817847 A CN01817847 A CN 01817847A CN 1622790 A CN1622790 A CN 1622790A
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China
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screw
bone
hole
implant
cortex
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CNA018178472A
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CN1307952C (zh
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斯罗博丹·特皮克
安德鲁·W·霍奇
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Abstract

假体构件在骨髓腔内用螺钉(5)固定可解决传统的压配合无胶泥固定所遇到的微运动问题。对于全髋骨假体(10)，骨干(1)只是固定在近股骨的中皮层上，这样可省去在边皮层上钻孔的需要。骨干(1)可用特制的钻孔导引器械植入。锚定螺钉(5)被锁定在股骨构件(10)的骨干(1)内，同时螺钉头(17)上的自切割螺纹与预先钻孔的中皮层接合。这种新颖的固定原理也可应用到其他关节假体上，如手指、肩、肘和膝以及牙齿和脊柱的植入物。

Description

螺钉锚定的关节假体
技术领域
本发明总的涉及一种改进的关节假体。
本发明的背景
自从全髋骨更换(THR)被广泛接受使用以来已有三十年，矫形外科手术的医疗已发生变化。为了支持THR，一个完全新的工业已经兴起更重要的是，THR已经改善了数以百万计的病人的生活质量，其程序是外科手术历史上任何其他单项处置所不能并驾齐驱的。所有这些原本是随着胶泥粘固的THR的出现才变得可能。在跟随Charnley的先驱工作的第一个十年内，外科医生受训的广泛基础被高度刺激的工业及应允的医疗保险策略曾导致THR在世界范围内被接受，这可从做这种处置的人数的指数增长、目前在世界上每年已超过600,000取得证明。
但这种无限乐观的早期接下来就受到革新数波的冲击，这时已经有长期使用的结果，并且修正(更换或卸除THR的股骨或髋臼构件中的一个或两个)次数也开始爬升。关于修正次数的增加，大多数责备都归咎于骨胶泥，并且力图用所谓无胶泥的锚定来消除修正率的增加，这时无胶泥的锚定在第二个十年中占主导地位。接下来再一次发生变化，长期临床治疗的结果逼迫人们改变策略-因为无胶泥的THR设计不能适应用胶泥粘固的Charnley型的髋假体的整套标准设计。
尽管有合理地均匀分布的医疗培训项目和广泛地供应的和现成的专业文献，但在各个不同的地理区域内一直到现在并可能这样继续下去，在控制THR的实施的态度方面有显著的差异。在有些国家内超过95％的THR处置是胶泥粘固的(如瑞典)，但也有些国家无胶泥占优(如德国)THR的大约三分之二是无胶泥的。混合的THR(即在其中一个构件是用胶泥粘固的，而另一个不是)也曾得到强烈的追随，特别是在美国，通常髋臼构件是无胶泥而股骨骨干用胶泥粘固，但相反的方案也有一些支持者，而且后一种情况根据某些近来刊出的临床治疗的结果也不是没有优点的。
瑞典髋骨登记处(以及较晚在挪威和芬兰实现的登记处)曾用仪器清除那些功效差的方案。但目前在世界范围内可供的髋骨设计中只有有限数目的设计在瑞典被使用，其数量大到足够从中汲取任何结论。许多革新的失效还曾产生一个非常谨慎的外科手术群体，特别是在斯堪迪那维亚半岛上。从该登记处作为对植入物和外科技术的选用实行监控的结果而出版的数据(包括个别诊所完成的情况)来看，目前的瑞典所做的THR处置十个中只有一个是修正的。作为比较，较不精确的数据表明在美国五个THR处置中有一个是修正的，而在德国可以多到三个或四个THR处置中有一个是修正的。
修正外科手术的频率除了假体设计外取决于许多因素。但无可争议的是，其中一个主要因素即用胶泥粘固的THR与无胶泥的THR相比，前者的功效仍较优越。在瑞典登记处的记录内，就修正的总比率而言，无胶泥的THR比使用现代技术用胶泥粘固的THR大一倍。争论归结为用THR单一的结果参数来判断，这个参数是瑞典登记处作为依据的，即THR的“保全率”。THR设计的保全率被定义为保留在病人体内的这种THR(即不被修正的)所占的百分比。由于在十年长的时间内对于一个良好的假体和适当使用的良好的胶泥来说，保全率差不多为95％，因此看上去促使革新的压力似应比通过改变市场上现有THR的型式并继续努力改进无胶泥设计和胶泥粘固技术从而提供建议小得多。目前推动新的革新的理由之一是因为外科医生和植入物制造商都需要有一些新的东西来取得人们的赏识和市场的份额，而这是在用胶泥粘固的Charnley技术的不再分化的领域内难于取得的。
尽管用胶泥粘固的THR有95％的十年保全率，但人们认识到在长期使用时还有些问题需要解决。因此最近瑞典登记处承担了一个项目，就是要对少量没有要求修正的情况(即一直到现在还没有将使用结果报给登记处)所取得的功效进行估计。预计结果将示出在十年中大约有15％的病人具有失效的THR，但没有被修正是由于各种原因如病人的年事已高(预期剩下的寿命有限)。在青年病人中修正率较高，现有的无胶泥THR似乎并没有作出任何肯定的冲击。
因此在长期使用中需要解决的传统的THR方法所受到的限制可以总结如下：
*在适当设计的用胶泥粘固的骨干内，大多数失效是由于骨胶泥的疲劳持久极限不够而造成的(导致所谓无菌的松动)；
*在无胶泥的骨干内，大多数失效是由于骨干和骨在界面上的运动引起的骨的流失造成的；
*在髋臼构件内，由于难以使植入物与高度柔顺的海绵状骨匹配，不管是用胶泥或不用胶泥，都会在界面上导致形成软组织，以致会发展为总体不稳定；
*对发生相对运动的所有界面上产生的磨损碎屑的生物反应，不管是有意的或无意的，包括人造关节本身，都能导致活化骨的再吸收即所谓骨质溶解，这会发展到假体构件的整体松动或者甚至骨折。
本文所说明的本发明成功地向假体构件对骨的接合面问题提出挑战，它可使病人在紧接着手术后的时期内不受限制地使用更换的关节，该关节可在无限长的时间内锚定在骨上。本发明十分详细地说明全髋骨假体的股骨构件的一个例子，但显然同样的原理能被应用到许多其他假体上，例如肩(肱骨构件)、肘(两个构件)、膝(两个构件)、手指(两个构件)，还可应用到牙齿和脊柱的植入物上。在本说明中，那些其他方面的应用只是概略地提一下，本行业中设计和使用这些构件的行家仿效全髋骨假体的例子，肯定能生产出所有必需的植入物、器械和插置程序。
本发明可除去现有技术中所知全髋骨假体的用螺钉固定的股骨构件的缺点，这个缺点在美国专利5,458,654号(′654专利)中曾举例说明，即必需在股骨近端(或上端)的侧边皮层内钻出进入孔，并且伴随着还需要切开侧边皮层上面的软组织和肌肉。本行业的行家当然都知道，对软组织或骨的任何不必要的伤害最好都应避免，因为对病人身体的伤害由于健康的骨基质被拿掉并有机会被感染，会使股骨变弱。
本发明的综述
本发明的一个目的是要提供一种矫正外科的植入系统，该系统包括一个矫正外科的植入物和至少一个骨螺钉。矫正外科的植入物包括一个骨内部，该骨内部具有第一侧、第二侧和至少一个螺钉孔。螺钉孔在第一侧有一进入孔和内螺纹部。骨螺钉有一外螺纹的前端可与螺钉孔的内螺纹部接合，还有一外螺纹的头部可与骨接合。当这螺钉的前端与螺钉孔的内螺纹部接合时，螺钉便被锁定在植入物内，螺钉之被锁定除了由于螺纹接合外，还由于螺钉零件与植入物的相互配合。
这个矫正外科的植入系统可被用于具有近皮层、远皮层和骨内区域的骨；在前一种情况下，骨螺钉的外螺纹的头部与骨的近皮层接合，从而将矫正外科的植入物耦合到骨上与近皮层(的内表面)紧密接合。螺钉孔可以是通到骨内部第二侧的通孔，在后一种情况下，螺钉的前端可与骨的远皮层接合。骨螺钉在其前端和头部之间还可设有过渡部，过渡部设有自行攻丝的排屑槽。螺钉前端的螺纹可具有与头部螺纹基本相同的节距。
这个矫正外科的植入系统可包括一个导引件，该导引件锁定在植入物上并且当被锁定时其导引孔与骨内部的螺钉孔同心。
螺钉孔还可具有圆锥形的带锥度部分，其直径从进入孔到第二侧逐渐减小。螺钉的圆锥形锥度的中间部，其半圆锥角适宜为约1到约15度，更好为约3到约8度，最好为约5度。相应的骨螺钉具有的圆锥形锥度的中间部，从靠近头部的大直径到靠近前端的小直径的锥度一般与螺钉孔的锥度匹配。
在这个系统中，最好第二螺纹直径大于中间部的大直径，而第一螺纹直径小于中间部的大直径。当螺钉被插入到骨内部内时，骨螺钉的前端与螺钉孔的内螺纹部接合，随着螺钉的前进，这个接合拉动螺钉的圆锥形锥度的中间部与螺钉孔的圆锥形锥度的中间部接合，从而锁定螺钉和矫形外科的植入物。
本发明另一个目的是要提供一种髋关节假体的植入系统的实施例。在这实施例中，植入物包括一个具有骨髓腔内骨干的股骨构件。骨髓腔内骨干具有一个中侧、一个边侧、和至少一个螺钉孔。这个髋关节假体适宜用于具有中皮层、边皮层和骨髓腔内区域的股骨，在该情况下骨螺钉的外螺纹的头部与中皮层接合，从而将股骨构件耦合到股骨上与中皮层(的内表面)紧密接合。
本发明还有另一个目的是要提供一种改进的方法以资使用螺钉而不是使用胶泥将矫形外科的植入物植入到一个具有近皮层和远皮层的骨内，该植入物具有一个骨内部要被植入到病人的骨内。改进包括下列几点：将骨内部插置到病人的骨内；插入骨螺钉，首先通过近皮层，然后插入到植入物内；使螺钉的前端与植入物的骨内部接合，而螺钉的头部与骨的近皮层接合；将矫形外科的植入物耦合到骨内与近皮层(的内表面)紧密接合。
这个方法还包括下列步骤：提供一个具有骨内部的矫形外科植入物，在该骨内部上具有至少一个螺钉接纳孔；在骨的近皮层内钻出一个螺钉孔，该孔基本上与骨内部内的螺钉接纳孔对准，在骨的第二皮层内不需钻出对应的同心孔；并且其中插入骨螺钉的步骤包括插入螺钉使它通过在近皮层内的螺钉孔并进入到螺钉接纳孔内，其时转动螺钉使它在从病人骨的近皮层向远皮层的方向前进。
该方法还可包括在骨的远皮层内钻出螺钉孔的步骤，该螺钉孔一般与在骨的近皮层内的螺钉孔同心。在这情况下，持入骨螺钉的步骤包括插入螺钉使它通过近皮层内的螺钉孔并进入到螺钉接纳孔内，其时转动螺钉使它在从病人骨的近皮层向远皮层的方向前进，直到骨螺钉与远皮层内的螺钉孔接合。
该方法还可包括提供具有外螺纹的前端和外螺纹的头部的骨螺钉的步骤。在这情况下，当锚定螺钉被插入到近皮层内的螺钉孔内并进入螺钉接纳孔内时，螺钉前端的螺纹可在头部螺纹与近皮层接合之前与螺钉接纳孔的螺纹部接合。该方法还可包括这样的步骤，提供一个具有圆锥形锥度的中间部，该中间部在朝向前端的小直径到朝向头部的大直径具有锥度；以及在中间部和头部之间提供一个过渡部，该过渡部设有自行切割的排屑槽。在这情况下，当锚定螺钉被插入到近皮层内的螺钉孔内并进入螺钉接纳孔内时，螺钉前端的螺纹可在过渡部的自切割排屑槽与近皮层接合之前与螺钉接纳孔内的螺纹部接合。
该方法还可包括提供一个导引件的步骤，该导引件锁定在假体上并且当导引件锁定时其导引孔与骨内部内的螺钉孔同心，使用该导引孔可在病人骨的近皮层内钻出螺钉孔。
本发明尚有另一个目的是要提供一种方法，该方法能有效地被用来按照上面总结的原理将髋关节假体的股骨构件植入到病人股骨的骨髓腔内。
本发明再有另一个目的是要提供一种无胶泥髋关节假体用的股骨构件，该股骨构件具有一个骨髓腔内的骨干可用来插置到股骨的骨髓腔内区域，其中骨髓腔内骨干的一种大小就可用于宽广范围的股骨大小。这种股骨构件能够有效地被使用于所准备的股骨构件只具有一种大小的骨干而要配合宽广范围的股骨大小的场合。
附图的简要说明
从下面本发明的详细说明中可对本发明的特点和优点有较清楚的了解。在附图中：
图1为按照现有技术的髋假体的无胶泥股骨构件的前平面剖视图。
图2为按照本发明的髋假体的无胶泥股骨构件的前平面剖视图；
图2A为图2中沿A-A线的横断剖视图；
图2B为图2中沿B-B线的横断剖视图；
图3为按照本发明的锚定螺钉的部分侧视图和部分前平面剖视图；
图4为按照图2的股骨构件的部分侧视图和部分前平面剖视图，还示出一个插入/钻孔的导引件和相关的器械装置；
图5为图2所示假体的骨干内的螺钉接纳孔的细节的前平面剖视图；
图6为图5中的螺钉接纳孔的细节的前平面剖视图，还示出在骨内钻出的对应孔；
图7为一部分侧视图和部分前平面剖视图示出图3中的骨内攻丝的锚定螺钉部分插入到骨和股骨构件内的情况；
图8为一部分侧视图和部分前平面剖视图示出图3中的骨内攻丝锚定螺钉完全插入到骨和股骨构件内的情况；
图9为本发明的手指关节假体实施例的部分侧视图和部分前平面的剖视图。
较优实施例的详细说明
现有技术
如同上面的详细论述，关于用胶泥粘固和不用胶泥(无胶泥)的髋骨假体，现已成为一个扩展的行业，这个行业有它已被确认的问题，包括由于疲劳持久极限不够而造成的失效；由于骨干和骨在界面上的运动引起的骨的流失；在界面上形成的软组织会发展为总体不稳定；及骨质溶解会发展为假体构件的整体松动或者甚至骨折。虽然在′654专利中公开的设计解决了许多这类问题，但从外科手术的观点来看，仍有不少可以改进的空间。
无胶泥的、用螺钉固定的股骨构件为本行业所公知，这种如同在′654专利中公开的构件在图1中示出。螺钉112A到112E将股骨构件连结到中皮层152上，这样就克服了用胶泥粘固的股骨构件的一些问题。但这个设计要求对病人身体的一部分作出伤害，而这伤害是长期固定构件并不需要的。例如螺钉112的设计要求将这些螺钉首先插入通过股骨构件的骨干101，然后插入到中皮层152内并与它接合。由于这个设计，外科医生必须在边皮层154上钻出开通孔153A到153E。这些开通孔必须具有较大的直径，因为它们必须允许包括头部在内的整个螺钉通过。当然，为了制出这些开通孔，外科医生必须首先切通软组织和肌肉才能接近边皮层。要知道组织的切开和股骨侧边上的开通孔都不是将股骨构件固定在骨上所实际需要的，之所以需要只是为了使根据现有技术的假体设计的植入工艺过程得以进行而已。
按照本发明的全髋骨假体的股骨构件的锚定
图2为近(或上)股骨和锚定在位的本发明的全髋骨关节的股骨构件的剖面图。该剖面是在植入物的平面内切取的，植入物的平面相当于被切除的股骨颈的平面(该平面通常被旋转约10到15度转到抗侧转的位置，即让头部指向前方)。如同在传统的假体中那样，假体的骨干1被放置在股骨3的骨髓3的骨髓空腔2内。但与传统的用胶泥粘固的假体不同，骨干是用多个螺钉5a到5e只是锚定在中皮层上，没有与边皮层7接合。使用这种固定系统，股骨构件可被牢固地耦合在股骨上与中皮层的内表面紧密接合。在讨论中的骨的各个皮层一般可给予在上下文中规定的指称，如“第一”和“第二”皮层，或“近”和“远”的皮层。在后一种情况下，应该知道“近”皮层为接近于或面向正在特定位置考虑该骨的外科医生的皮层。与此相反，应该知道“外”皮层为离开或背离外科医生的皮层。
最好在骨干1与股骨3的边皮层7之间应有间隙6即两者不接触。这个间隙最好沿骨干的整个长度延伸。换句话说，骨干在其长度上没有一个点是完全填满骨髓腔管的。因为骨干只是部分填满骨髓腔管，因此允许该骨继续经受其正交负载应力的大部分而不会使该骨受到环状变化的应力，这种应力可从已知的无胶泥或压配合的设计中得出。另外，本发明的骨干的部分填满的方案允许用单一大小的骨干来配合一个范围很广的股骨大小。与此相反，已知的系统必须提供多到一打的骨干大小来配合众多的股骨大小。本发明这样配置和锚定的目的就是要避免在骨干和骨之间的相对运动(因此还能避免碎屑的产生和骨的再吸收)。在股骨近端部内的柔软的海绵状骨8最终会生长到填满间隙6，但假体的稳定性并不要求在这个区域内有稳定的、直接的骨接触。最近的螺钉5a的位置大致在较小转子9的水平上。股骨构件的颈10还是传统的型式，头部11也是如此。最好头部是模块式的并由陶瓷或金属制成。
在承受重量的条件下，关节力12指向中间固定部，载荷被分给各个锚定螺钉，主要是剪力。连结在较大转子上的腿的肌肉产生一个力13向上拉向骨盆，还有一个力14向下拉向膝盖。在传统的型式中，骨髓腔管填满的骨干用压配合锚定时，造成的股骨的变形不可避免地会导致在骨干和骨之间界面上的相对运动。这种剪切或“摩擦”的运动主要应受到谴责，不仅因为它最终能使构件松动，而且因为它能使大腿疼痛，这是无胶泥固定时的一种常见的临床并发症。对某些病人，这种状况能变成长期的慢性病。
图2A示出在最近螺钉的位置上的横断剖面图。从图中可见锚定螺钉5a被插入到骨干1的螺钉接纳孔15内。该螺钉接合骨干1和中皮层4。重要的是该锚定螺钉的适当功能为既填充螺钉孔的中部，又牢固地与骨干1接合或被锁定在骨干1内，使它能传递弯曲载荷以及剪切和轴向的载荷。
如从图2可见，在所示状态下骨干1的远(或下)部相对于螺钉的长度来说过窄，这样螺钉就不能完全被包含在骨干内。因此为该螺钉准备的螺钉孔就不是“盲”孔，而是一个延伸通过骨干的直径来到侧边的通孔，侧边孔的出口会令人讨厌地造成应力上升区或应力集中。为了减少在侧边孔周围的应力集中，因此在骨干的侧面上切出一个凹部16。这个凹部可从图2B的横断剖面上看到。
虽然在图2中所示的最近的螺钉5a是一个在盲孔内的短螺钉，但在另一个实施例中这个孔和螺钉为了求得不同的功能特性可被修改。这时该孔可被制成通孔从居中侧到边侧而完全通过假体，而螺钉5a将具有足够长度可接合到在骨髓腔管另一侧的边(或远)皮层的骨，包括海绵状区域8，最好还包括边皮层的骨7。这样螺钉5a就在两个位置上支承在股骨内，从而可用来承担扭转载荷，否则扭转载荷会集中在单一位置上。
锚定螺钉的设计在图3中较详细地示出。这个骨螺钉具有：一个圆柱形的小直径前端部17，在其外表面上设有机器型螺纹；一个圆锥形有锥度的中间部18；和一个圆柱形头部或骨接合部19，有一供插入工具(如螺钉旋凿)用的凹部20。头部19制有外螺纹，该螺纹最好与部分17的螺纹具有基本相同的节距。在中间部和头部之间还可有一过渡部37。这个过渡部最好设有自攻丝或自切割的排屑槽38。当该螺钉在位被转动时，这些排屑槽就开始切割中皮层内的螺纹，该螺纹与头部的螺纹接合。
头部的螺纹直径(在螺纹的顶部上测量)为DH，中间部在其大直径端的大直径为Dmaj，在其小直径端的小直径为Dmin，而前端的螺纹直径为DF。对于特定用途，上述各个直径虽可变动，但为了能适当牢固地将股骨构件锁定在股骨上，最好遵守下面的关系DF≤Dmaj≤DH。换句括说，前端的螺纹直径应小于有锥度的中间部的大直径，而后者又应小于头部的螺纹直径。采用按照该关系设计的螺钉和相应的孔，螺钉的有螺纹的部分和有锥度的部分将能适当地完成它们各自的承担载荷的功能。
中间部的锥度角或圆锥18不一定要像“莫尔斯锥度”设计中摩擦锁定所典型要求的那么小，因为它在骨干的螺钉接纳孔15内的锁定是由螺纹部17的拉紧保证的。半圆锥角(在中心线每一侧的角度即总圆锥角之半)的较优范围从约1到约5度；对于本用途(髋骨假体)，该角最优约为5度。采用这个角度，圆锥能被安全地锁定在接纳孔内，这样骨干从螺钉孔内到沿着中侧都能得到增强(支承)，这一点对于总的骨干强度很重要。如果螺钉孔留出空洞或者没有适当地被螺钉填充，那么螺钉孔能导致骨干的疲劳失效。
虽然螺钉在孔内的牢固锁定能单纯用螺钉和植入物上螺纹的配合来做到，但这种螺纹的配合关系很难用机加工足够精确地制出以致在植入后微运动还是不可避免。这种运动是不希望有的，因为它会导致磨损、腐蚀和其他与磨损有关的问题。本发明的匹配的锥度设计能够将螺钉紧密而牢固地锁定到植入物上而不会有这种微运动的问题。但将螺钉锁定在孔内并非必需用匹配的如图中所示的锥度。重要的是将螺钉锁定在植入物上，在螺钉受到轴向的、剪切的、和扭转的载荷时，螺钉须能保持牢固的固定。例如在另一个实施例中，植入物可以部分或全部由软材料(如软的金属、复合材料、或塑料)制成，并没有预先制出的螺钉孔，或者具有的螺钉孔只是部分制出。在这实施例中，螺钉可在骨干内攻出它自己的螺纹，这样来将螺钉牢固地锁定在构件上而可不用锥度。在还有另一个实施例中，螺钉孔可仍有带螺纹的部分，螺钉上可带锥度的部分，但螺钉孔内没有与螺钉上的锥度对应的带锥度的部分。而是螺钉孔在接受螺钉锥度部的部分上设有由软材料制成的嵌入物，使当螺钉前进到孔内时，螺钉的锥度部压迫嵌入物，这样来将螺钉牢固地锁定在构件上。
髋关节用传统的切开和以前的侧边接近法来接近。一旦髋关节被暴露，它就被脱位，使股骨与骨盆分离，并可接近股骨颈。然后在颈的基部切割股骨使头和颈与股骨的其余部分分离。在近股骨内暴露的海绵状骨被钻孔使骨髓腔内沟外露。然后将该沟用扩孔器或锉扩宽到足够接纳股骨构件的骨干。
假体的插入及其在近股骨上的锚定最好借助于如图4所示的特制器械来完成。与已知的用螺钉固定的股骨构件如在′654专利中公开的股骨构件(在图1中示出)所需的接近法成为尖锐的对比，本发明的植入使用的是中间接近法。股骨在外面被转动到一个极端位置使外科医生能够进入到骨的中间方面。肌肉被分离使植入物和导引组合件能够放入。如同下面还要较详细地说明的那样，螺钉从中间向侧边的方向在主肌肉嵌入物之间插入到骨内。
用螺钉23将便于插入和钻孔的导引件22牢固地锁定在骨干的颈10上，并将假体和导引件之间的旋转位置(环绕颈的轴线)固定在假体的肩部区域24内。当导引件和股骨构件这样被固定在一起时，在导引件体内的导引孔25a到25e被设置得与骨干1内的螺钉接纳孔的取向同心。
钻孔导引件22最好这样成形使骨干在中间的表面和导引件在中间的表面之间的距离26对所有的螺钉位置都相等。一旦骨干1被放置在骨髓腔管2内，便可将一个或两个部分制有螺纹的定位螺栓28插入到钻削导引孔内并将它们旋入到导引件内一直到其尖端抵压在中皮层或近皮层上，这样骨干1便与中皮层4紧密接合，从而便可将假体暂时保持在适当的位置。某些或所有钻孔的中间部29都可制有螺纹以便接纳带螺纹的定位螺栓28。
一旦外科医生判断认为骨干在股骨内的位置正确(包括所需的抗侧转角)，便可用特制的钻头30在中皮层4上钻出锚定螺钉孔。为了尽可能减少对软组织的伤害，该软组织可以，但并非必须完全从骨上后退，可使用一个振荡钻孔机来驱动钻头作正反转动如箭头31所示。钻头30的前端部32具有一个略小于骨干1内接纳孔的直径。这样钻头30的部分32和孔15便形成一个定中心系统，该系统能自动导引钻头30的切割部33对皮层所作的最终钻孔使该孔适当同心地对准螺钉接纳孔的中心。钻孔部33所产生孔的直径应等于或略小于锚定螺钉5的带螺纹的螺钉头19的心部(螺纹底部)直径(见图3)。钻头30可设有肩部34以便限制钻头的穿透而使它达到以正确的预定深度。
在第一锚定螺钉被插入后，最好在沿着骨干长度的中间位置上将其他锚定螺钉一次一个地插入到导引件上没有放置定位螺栓的孔内。然后将定位螺栓撤走并在那些位置上同样插入锚定螺钉。在将股骨构件这样牢固地与股骨接合后，植入程序的其余部分便可按照已知髋骨假体用的标准程序进行。
螺钉孔的几何形状
骨干1内的螺钉接纳孔15的形状在图5中详细示出，从其中可见骨干1与中皮层4的内表面紧密接合。另外还可见到，某些螺钉孔(具体地说，与螺钉5a-5c相关的孔)是“盲”孔，它们并不从边侧到中侧全程延伸通过骨干，而其他一些螺钉孔(具体地说，与螺钉5d和5e相关的孔)是“通”孔，它们从骨干的一侧延伸到另一侧。孔15的端部35为一内螺纹部用来接纳螺钉5(见图3)的前端或骨干接合部。该螺钉孔有一在骨干的中间表面上的进入孔和一圆锥形锥度部34，其圆锥形锥度的形状相当于锚定螺钉5(见图3)的圆锥形锥度的中间部18，该中间部的直径从靠近进入孔的端头向骨干的中侧逐渐减小。
图6示出在股骨的中皮层内(如图4所示)对应孔被钻出后的情况。在中皮层4内孔的直径36最好等于或略小于螺钉头的带螺纹的骨接合部19的心部(螺纹底部)直径。进入直径36最好与接纳孔的圆锥形部34的进入直径34大致相同。一旦该孔在中皮层内被钻出，便可将锚定螺钉插入。
最好，螺钉和孔的尺寸被这样制定，使螺钉5的前端接合骨干1内的螺纹部35发生在设有切割排屑槽38的过滤部37开始切割骨内的螺纹之前，这样在系统内就不会有预应力，如果骨内的螺纹在螺钉和骨干接合之前切割，那么预应力就会发生。将螺钉牢固地插入便可拉动螺钉的圆锥部18使它进入到螺钉孔的接纳部34内。
图7示出锚定螺钉在插入到骨干和骨内的中间位置的情况。骨干接合部17上的螺纹已有深度“x”与螺纹部接合，而骨接合部19上的螺纹则在一较小的深度“y”内切割到骨内并与骨接合。在图8中，锚定螺钉5被完全插入到骨干1的孔15内。在前端17上的螺纹将螺钉固定在股骨构件上，而在骨接合部19上的螺纹将螺钉固定在中皮层4上。这样螺钉就用机械方法将骨干1固定在中皮层4上。从图8显然可见，即使在“完全”插入位置，螺钉头19的某些部分仍旧会延伸到中皮层的表面之外。
如前所述，对于螺钉来说，重要的是须将螺钉牢固地锁定在骨干上，使任何弯曲力矩能被抵挡而螺钉在其螺钉孔内不会倾侧。使用传统螺钉就是由于这种螺钉相对于骨干会发生倾侧运动导致螺钉在骨内过早就会松开。
本发明在其他假体和植入物上的应用
本发明的主要动机是要解决在较年青的病人中完成的全髋骨更换中股骨构件的松弛问题。但本行业的行家当会知道上面所说的锚定原理能被立即用到其他植入物上，如同骨髓腔内的钉子、手指关节假体、肩部假体、牙齿植入物和脊柱植入物。确实，在任何矫形外科手术的场合，如果在一个骨的内部区域的两侧各有一个皮质骨区域(一般可被称为第一和第二皮层，或者根据参照的框架称为近和远的皮层)，本发明都可应用。这时可使用螺钉，通过骨上选定的皮层将矫形外科植入物的骨内部固定到骨内使与所选皮层的内表面紧密接合，而可不需在另一个皮层上钻孔。
例如一个骨髓腔内的钉子可被用来将断裂的骨段锁定在一起而用本发明的方法将它们固定。这个实施例的锚定螺钉可被制成单皮层的或双皮层的；如果是双皮层的，那么螺钉的前端也应制成自行攻丝的。这时在近皮层上要钻出镙钉孔，在远皮层上也要钻出同心的螺钉孔。
图9示出本发明的另一个实施例，其中在掌骨40和相应手指的第一骨41之间的自然关节已被一个球窝型的全假体56所替代。自然关节的在掌骨上的头部50已被人造关节的承窝43替代，而自然关节的底(内凹)侧已被人造关节的球42所替代。这样的颠倒可有较大的运动范围而可较方便地切除在平面51上的头部50和在平面53上的底部。可以有大于90度的弯曲48而不会有假体构件或骨的碰撞，还可有超过30度的伸展49，这一点可与这个关节的自然范围比美。假体关节的球42被承载在远骨干44上，该骨干系按本发明的方法用螺钉45a到45c固定在手指骨41上。关节的承窝43被承载在假体的近骨干46上，该骨干也是按照本发明的方法用螺钉47a到47c固定在掌骨40上。如图所示，固定在背皮层54上较好，因为外科手术方法较简单，但是要固定在掌皮层上也是可能的。
不管本发明在矫形外科上的特定应用，使用螺钉作为主要固定方法并不排除使用多孔镀层，例如钛等离子体、羟磷灰石等，这是为了增添骨向内生长的稳定性。这法如果使用，这种镀层最好应只施加在骨干上的那些骨向骨干的移动被螺钉阻止的区域。例如，在全髋骨假体中最好只是骨干的中间方面被镀覆。这种镀覆方法被用来防止所谓“应力屏蔽”产生的后果即能导致大量骨质长期流失。单独固定在中皮层比同时固定在中皮层和边皮层能较多减少正交应力式样的歪曲。而且，如果骨髓腔的一些部分保留不受损伤，或者至少不是完全被植入物填满，那么骨再生肌肉的潜力将会高得多。
虽然在上面说明了本发明的较优实施例，但显然本行业的行家是能在不离开本发明的创意和范围的情况下作出各种改变和修改的。

Claims (45)

1.一种可用来植入到病人骨内的矫形外科植入系统，该系统包括：
一个矫正外科的植入物，该植入物包括一个骨内部，该骨内部具有：
一个第一侧；
一个第二侧；和
至少一个螺钉孔，该螺钉孔有一内螺纹部；
至少一个骨螺钉，其上有：
一制有外螺纹的前端，可与螺钉孔的内螺纹部接合；和
一制有外螺纹的头部，可与该骨接合。
2.权利要求1的矫形外科植入系统，其特征在于螺钉前端与螺钉孔内螺纹部的充分接合使螺钉锁定在植入物上。
3.权利要求2的矫形外科植入系统，其特征在于螺钉除了前端以外的部分与植入物除了螺钉孔内螺纹部以外的部分的互相配合有助于将螺钉锁定在植入物上。
4.权利要求1的矫形外科植入系统，其特征在于该系统可被用于具有近皮层、远皮层和骨内区域的骨，并且其中外螺纹的螺钉头还与骨的近皮层接合，从而将矫形外科的植入物耦合到骨上与近皮层的内表面紧密接合。
5.权利要求4的矫形外科植入系统，其特征在于螺钉孔为一从植入物骨内部的第一侧延伸到第二侧的通孔，并且其中螺钉的前端还与骨的远皮层接合。
6.权利要求1的矫形外科植入系统，其特征在于骨螺钉还具有一个处在其前端和头部之间的过渡部，过渡部设有自行攻丝的排屑槽。
7.权利要求1的矫形外科植入系统，其特征在于螺钉前端的螺纹具有与螺钉头部螺纹大致相同的节距。
8.权利要求1的矫形外科植入系统，其特征在于还包括一个导引件，该导引件锁定在植入物上，并且当被锁定时，其导引孔大致与骨内部的螺钉孔同心。
9.一种用来植入到病人骨内的矫形外科植入系统，该系统包括：
一个矫形外科植入物，该植入物包括一个骨内部，该骨内部具有：
一个第一侧；
一个第二侧；和
至少一个螺钉孔，该螺钉孔具有：
一个在第一侧的进入孔，
一个从进入孔到第二侧的直径逐渐减小的具有圆锥锥度的中间孔部，和
一个处在中间孔部和第二侧之间的内螺纹部；
至少一个骨螺钉，该螺钉具有：
一个制有外螺纹的前端，用来与螺钉孔的内螺纹部接合，该前端具有第一螺纹直径；
一个制有外螺纹的头部，用来与骨接合，该头部具有第二螺纹直径；和
一个处在前端和头部之间的圆锥锥度中间螺钉部，其锥度范围从靠近头部的大直径到靠近前端的小直径。
10.权利要求9的矫形外科植入系统，其特征在于第二螺纹直径大于中间螺钉部的大直径，而第一螺纹直径小于中间螺钉部的大直径。
11.权利要求9的矫形外科植入系统，其特征在于当将螺钉插入到骨内部时，骨螺钉的前端与螺钉孔的内螺纹部接合，随着螺钉的前进，这个接合拉动中间螺钉部与中间孔部接合，从而将螺钉和矫形外科植入物锁定。
12.权利要求11的矫形外科植入系统，其特征在于该系统用于具有近皮层、外皮层和骨内区域的骨，并且其中外螺纹的螺钉头部与骨的近皮层接合，从而将矫形外科植入物耦合到骨上与近皮层的内表面紧密接合。
13.权利要求9的矫形外科植入系统，其特征在于螺钉孔为盲孔，且不延伸到骨内部的第二侧。
14.权利要求9的矫形外科植入系统，其特征在于螺钉孔为通孔，该孔延伸到骨内部的第二侧。
15.权利要求14的矫形外科植入系统，其特征在于螺钉的前端还与骨的远皮层接合。
16.权利要求9的矫形外科植入系统，其特征在于中间螺钉部的半锥角从约1度到约15度。
17.权利要求9的矫形外科植入系统，其特征在于中间螺钉部的半锥角从约3度到约8度。
18.权利要求9的矫形外科植入系统，其特征在于骨螺钉在中间螺钉部和螺钉头部之间还有一个过渡部，过渡部设有自行攻丝的排屑槽。
19.权利要求9的矫形外科植入系统，其特征在于螺钉前端的螺纹具有与螺钉头部的螺纹大致相同的节距。
20.权利要求9的矫形外科植入系统，其特征在于还具有一个导引件，该导引件锁定在植入物上，并且当锁定时其导引孔与骨内部的螺钉孔大致同心。
21.一种髋关节假体包括：
一个具有骨髓腔内骨干的股骨构件，该骨干包括：
一个中侧；
一个边侧；和
至少一个具有内螺纹部的螺钉孔；
至少一个骨螺钉，具有：
一个制有外螺纹的前端，用来与螺钉孔的内螺纹部接合，该前端具有第一螺纹直径；和
一个制有外螺纹的头部，用来与股骨的中皮层接合，该头部具有第二螺纹直径。
22.权利要求21的髋关节假体，其特征在于：
螺钉孔还包括：
一个在中侧的进入孔；
一个具有圆锥锥度的中间孔部，其直径从进入孔向边侧逐渐减小，和其中
螺钉孔的内螺纹部处在中间孔部和侧边之间，并且其中：
螺钉在头部和前端之间还包括一个具有圆锥锥度的中间螺钉部，其锥度范围从靠近头部的大直径到前端的小直径。
23.权利要求22的髋关节假体，其特征在于第二螺纹直径大于中间螺钉部的大直径，而第一螺纹直径小于中间螺钉部的大直径。
24.权利要求22的髋关节假体，其特征在于当螺钉被插入到骨干内时，螺钉的前端与螺钉孔的内螺纹部接合，随着螺钉的前进，这个接合拉动中间螺钉部与中间孔部接合，从而将螺钉和股骨构件锁定。
25.权利要求24的髋关节假体，其特征在于假体用于具有中侧、边侧和骨髓腔内区域的股骨，并且其中骨螺钉的外螺纹的头部与中皮层接合，从而将股骨构件耦合在股骨上，与中皮层的内表面紧密接合。
26.权利要求22的髋关节假体，其特征在于螺钉孔为盲孔并没有延伸到骨干的侧边。
27.权利要求22的髋关节假体，其特征在于螺钉孔为延伸到骨干侧边的通孔。
28.权利要求22的髋关节假体，其特征在于中间螺钉部的半锥角从约1度到约15度。
29.权利要求22的髋关节假体，其特征在于中间螺钉部的半锥角从约3度到约8度。
30.权利要求22的髋关节假体，其特征在于骨螺钉还具有一个在中间螺钉部和螺钉头部之间的过渡部，过渡部设有自行攻丝的排屑槽。
31.权利要求22的髋关节假体，其特征在于螺钉前端的螺纹具有与螺钉头部的螺纹大致相同的节距。
32.权利要求22的髋关节假体，其特征在于还包括一个导引件，该导引件固定在股骨构件上，并且当锁定时其导引孔与骨干上的螺钉孔大致同心。
33.一种使用螺钉而不是使用胶泥、将矫形外科植入物植入到一个具有近皮层、远皮层和骨髓腔内区域的骨内的改进方法，该植入物有一骨内部，改进包括下列几点：
将植入物的骨内部插入到骨的骨髓腔内区域内；
插入骨螺钉，首先通过近皮层，然后进入到植入物内；
使螺钉的前端部与植入物的骨内部接合；和
使螺钉的头部与骨的近皮层接合；
从而将矫形外科植入物耦合到骨内与近皮层的内表面紧密接合。
34.权利要求33的方法，其特征在于还包括下列步骤：
提供一个具有骨内部的矫形外科植入物，在该骨内部上具有至少一个螺钉接纳孔；
在骨的近皮层内钻出一个螺钉孔；和
在骨的远皮层内钻出一个螺钉孔，该孔与近皮层内的螺钉孔大致同心；
其中插入骨螺钉的步骤包括插入螺钉，使它首先通过在近皮层内的螺钉孔，然后进入到螺钉接纳孔内，转动该螺钉使它在从病人骨的近皮层向远皮层的方法上前进，而该骨螺钉与远皮层内的螺钉孔接合。
35.权利要求33的方法，其特征在于还包括下列步骤：
提供一个具有骨内部的矫形外科植入物，该骨内部具有至少一个螺钉接纳孔；和
在该骨的近皮层内钻出一个螺钉孔，而没有在该骨的第二皮层内钻出对应的同心孔，所钻螺钉孔大致与骨内部内的螺钉接纳孔对准；
其中插入骨螺钉的步骤包括插入螺钉，使它首先通过近皮层内的螺钉孔，然后进入到螺钉接纳孔内，转动螺钉使它在从病人骨的近皮层向远皮层的方向上前进。
36.权利要求35的方法，其特征在于还包括下列步骤：
提供一个外螺纹的前端和外螺纹的头部；
其中，当锚定首先通过近皮层内的螺钉孔然后被插入螺钉接纳孔内时，螺钉前端的螺纹可在头部螺纹与近皮层接合之前与螺钉接纳孔的螺纹部接合。
37.权利要求35的方法，其特征在于还包括下列步骤：
提供一个外螺纹的前端、一个外螺纹的头部、一个从靠近头部的大直径到前端的小直径逐渐缩小的圆锥锥度的中间部和一个在中间螺钉部和头部之间的过渡部，该过渡部设有自行切割的排屑槽；
其中当锚定螺钉首先通过近皮层的螺钉孔然后被插入螺钉接纳孔内时，螺钉前端的螺纹可在螺钉过渡部的自切割排屑槽与近皮层接合之前与螺钉接纳孔的螺纹部接合。
38.权利要求35的方法，其特征在于还包括下列步骤：
提供一个导引件，该导引件锁定在植入物上，并且当锁定时其导引孔与骨内部的螺钉孔大致同心；和
在引导孔内利用导引件，在病人骨的近皮层上钻出螺钉孔。
39.一种使用螺钉而不是使用胶泥将一个髋关节假体的股骨构件植入到病人股骨的骨髓腔管内的改进方法，该股骨构件具有一个骨髓腔内的骨干，改进包括下列几点：
将股骨构件的骨髓腔内骨干插入到病人股骨的骨髓腔管内；和
将骨螺钉插入首先通过股骨的中皮层然后进入到骨干内，使螺钉的前端与植入物的骨干接合，而螺钉的头部与中皮层接合，从而使股骨构件与股骨耦合与中皮层的内表面紧密接合。
40.权利要求39的方法，其特征在于还包括下列步骤：
提供一个髋关节假体的具有骨髓腔内骨干的股骨构件，而该骨髓腔内骨干具有至少一个螺钉接纳孔；和
在骨的中皮层上钻出一个螺钉孔，而未在骨的边皮层上钻出对应的同心孔，该钻出的螺钉孔大致与骨干内的螺钉接纳孔对准；
其中插入骨螺钉的步骤包括将螺钉首先通过中皮层内的螺钉孔然后插入到螺钉接纳孔内，转动螺钉使它在从病人骨的中皮层向边皮层的方向上前进。
41.权利要求39的方法，其特征在于还包括下列步骤：
提供一个具有外螺纹的前端和外螺纹的头部的骨螺钉；
其中当该锚定螺钉首先通过中皮层内的螺钉孔然后被插入螺钉接纳孔时，螺钉前端的螺纹在头部的螺纹接合中皮层之前与螺纹接纳孔的螺纹部接合。
42.权利要求39的方法，其特征在于还包括下列步骤：
提供一个骨螺钉的步骤，该骨螺钉具有一个外螺纹的前端、一个外螺纹的头部、一个从靠近头部的大直径到前端的小直径逐渐缩小的圆锥锥度的中间螺钉部和一个在中间部和头部之间的过渡部，该过渡部设有自行切割的排屑槽；
其中当锚定螺钉首先通过中皮层内的螺钉孔然后被插入螺钉接纳孔内时，螺钉前端的螺纹在过渡部的自切割排屑槽接合中皮层之前与螺钉接纳孔的螺纹部接合。
43.权利要求39的方法，其特征在于还包括下列步骤：
提供一导引件，该导引件锁定在股骨构件上，并且当将该导引件固定于股骨构件上时，其导引孔与骨干内的螺钉孔大致同心；和
在引导孔内利用导引件，在病人股骨的中皮层中钻出一个螺钉孔。
44.一种无胶泥髋关节假体用的股骨构件，该股骨构件具有一个骨髓腔内的骨干，可用来插置到股骨的骨髓腔内区域，其中骨髓腔内骨干的一种尺码适用于股骨尺码的宽广范围。
45.一种用来将一无胶泥髋关节假体的股骨构件植入到病人股骨的骨髓腔管内的改进方法，改进之处包括：
提供一个股骨构件，该构件具有一种尺码的骨干，但可配合宽广范围的股骨尺码。
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ATE486545T1 (de) 2010-11-15
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