CN101068510A - 假体元件 - Google Patents

假体元件 Download PDF

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Publication number
CN101068510A
CN101068510A CNA2005800379549A CN200580037954A CN101068510A CN 101068510 A CN101068510 A CN 101068510A CN A2005800379549 A CNA2005800379549 A CN A2005800379549A CN 200580037954 A CN200580037954 A CN 200580037954A CN 101068510 A CN101068510 A CN 101068510A
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CN
China
Prior art keywords
prosthetic element
guide
hole
prosthetic
anchor cavity
Prior art date
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Pending
Application number
CNA2005800379549A
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English (en)
Inventor
埃纳尔·萨德曼
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Individual
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Individual
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Publication of CN101068510A publication Critical patent/CN101068510A/zh
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Abstract

本发明涉及一种假体元件(1)，其具有为周围的骨骼或纤维组织限定了界面的外表面，其中，所述假体元件(1)设有至少一个用于组织生长的内锚定腔(6)和至少一个用于切割工具的引导机构(5)。引导机构(5)和锚定腔(6)基本上定位在由所述假体元件(1)的所述外表面所限定的所述假体元件的周边/周围内。锚定腔(6)和引导机构(5)是互连的，并且锚定腔(6)和/或引导机构(5)中的至少一个在外表面中具有开口，以便组织生长到元件(1)内。

Description

假体元件
发明领域
本发明大体涉及一种假体元件。根据本发明的假体元件可应用于关节替换外科手术，其中利用了将假体元件锚定在活组织如骨骼上的方法。根据本发明，假体元件的构造便于假体元件在必要时取下。
发明背景
假体元件，在较大滑膜关节像髋关节、膝关节或肩关节中的关节替换外科手术中，可以通过骨骼粘固粉(cement)，或通过像压配合或通过纤维和骨骼向上生长的锚定或在孔内的向内生长一样的非粘固粉式固定而锚定到骨骼上。目前，用骨骼粘固粉的固定已对年长的以及年轻的患者产生了最好的长期成效。因此，比粘固粉的元件更多的无粘固粉的元件已被取消，并且随后对胜任的替换外科手术的需求成为必要。
对于成功的替换外科手术，尽可能多地保存骨骼原质被认为是必要的。因此，理想地，无粘固粉的假体元件应允许对像骨骼一样的活组织适当的刚性锚定，并且另外，应对其进行设计，以便其可以被撤回(retrieved)，而不浪费成功的替换外科手术所需的活组织原质。本发明的目的就是满足这些需求。
用具有多个凹进的或凸起的部分的假体元件的无粘固粉的固定，如果骨骼向上生长，那么可以对像股骨一样的骨骼产生好的固定。因此，这种元件可能很难撤回。然而，这种凹进的或凸起的部分不能阻止在元件/组织界面处的微动动作。因为微动动作对行走的患者造成痛苦，当前的需求是消除或至少减小这些微动动作。而且，这种不稳定性导致不希望有的骨骼改变。这种设计因此已在患者体内产生了不良的效果。
假体元件的替换在许多场合下都是必要的。统计显示，与初次的操作相比，已经1到6次地作出了这种修正。这说明，需要找到取下这种假体元件的好的方案。
如果骨骼组织生长在粗糙表面上，那么像髋骨柄部(stem)一样的假体元件的精密压配合就可以对骨骼产生好的锚定。表面越粗糙，锚定越好。但是，表面越粗糙，越难以撤回。因此，粗糙表面的元件的撤回会非常麻烦。而必要骨骼原质的损失是不可避免的。
已为通过骨骼向内生长将假体元件锚定在骨骼上提出了若干种手段。这些手段之一包括，对例如髋关节移植物的移植物的一部分表面施加烧结球的涂层。
该方法的目的在于，提供表面多孔性，以促进骨骼向内生长。这种方法具有若干缺点，例如，会不利地影响材料的性能，难以控制涂有球的移植物的表面几何形状，以及表面的球可以从移植物迁移而在人造关节本身内造成严重的第三体磨损。另外，取下完全涂有球的髋关节或肩关节柄部会是灾难性的；即使临时取下大部分的骨骼，仍然有使骨骼破裂为若干块的风险。
在例如1983年9月2日公开的发明人为William H.Harris的US4406023和1985年8月27日公开的发明人为Jorge O.Galante等人的US 4536894的发明中，在移植物一部分上的网格件已用于锚定。像烧结球一样的这些网格件产生了好的锚定。尽管阻碍接近柄部下面的凸缘仅仅是中间地提供在上述发明中，但是取下这种移植物会是非常困难的。而必要骨骼原质的损失是不可避免的。
Austin More为股骨的断裂颈状部设计的无粘固粉的半假体移植物具有便于插入和可能撤回的光滑表面。为了获得近端的负载转换，提供了凸缘(collar)。而在柄部中具有两个用于骨块锚定的很大的开口。但是这种锚定不能阻止在骨骼/组织界面的不希望的微动动作。而且，为了撤回这种假体，锚定的骨块必须通过锯或使用凿子取下。凸缘自然地阻碍接近下面的柄部。因此，为了去除锚定，所需的手术开口越大，损失的骨骼原质越多。
为了获得比上述Austin More发明的1994年7月19日公开的名为髋关节的股骨部分的设计专利US 5,330,536设计更多的骨锚定，Karl H.Tager和Hans E.Harder为中空部假体添加了多个Austin More型的洞。自然地，锚定的洞越多，固定的越好，但是如认为必要的撤回也越困难。假设柄部的内部充填有骨骼组织，那么就可以促使通过骨骼向内生长穿过这些很大洞的锚定。从假体上部延伸到下部的中空空间为圆锥形的渐缩形远侧，以便帮助从上面地对充满在其内的多孔组织进行压缩。本发明的目的在于“为髋关节假体的柄部设计一种有效的构造，借此促进多孔材料的充填”。尽管该多孔材料的一些可能从假体的中空空间内取下，但是该程序不会独自将假体充分地松动到能够从股骨上去除假体。这种假体的取下包括，通向假体外部的较大手术开口来切割骨骼材料，以释放假体。该操作具有类似于用于上述的完全涂有球的柄部的方法的特征，并且导致骨骼原质的较大损失。
为了近端的负载转换，可能需要凸缘。US 4,623,353公开了一种柄部型股骨的假体，其包括设有用于切除机构的接近槽的凸缘，1986年11月18日Fredrick F.Buechel和Michael J.Pappas发明人因此在凸缘的每一个侧部都提供了一个接近槽。该接近槽提供了对柄部的近端部分的通道，但是，在假体元件的外部上使用锯或凿子会不可避免地导致骨骼原质的损失。而且，上述的槽仅产生了对于柄部的最上面部分的通道。
Maurice E.Muller为发明人的1982年7月24日公开的名称为Gerader，blattartiger Schaft für eine Gelenkendoprothese的发明EP 0078888经设计而没有阻碍接近在用于锚定骨块的柄部中的很大的Austin-More型的洞的凸缘。为了稍微减少撤回的问题，该发明还包括浅的纵向孔道，当用锤截断锚定件时，该孔道沿着移植物部分地引导凿子。然而，如以上所述，这种骨块锚定不能阻止在移植物/骨骼界面的不希望有的微动移动。其次，在撤回时，凿子(或锯)不可避免地破坏骨骼原质。远端的切割越多，骨骼原质的损失就越多。否则，股骨将破裂。
Michael A.Masini为发明人的2001年2月13日公开的名称为假体元件取下的装置和方法的US 6,187,012 B1包括一种“指引切割工具进入在假体和周围的骨骼之间的界面以产生更多的用于修正或其它目的的可控的分离的引导机构”。该引导机构可能在假体的外部上，或位于假体外部附近作为在外部打开的半圆形的平行的具有在假体的外部表面中的开口的孔道。这些引导必须是平行和平直的，否则外部的切割工具会被卡住。因此这些引导仅可以用于弯曲的假体元件的上部。并且如上所述，使用切割工具进入在假体和周围的骨骼之间的界面会不可避免地导致骨骼原质的损失，或者会使骨骼破裂。
EP 181586涉及一种假体元件，其包括设有分布在假体主体的圆周周围的突出肋条的假体主体。肋条在纵向方向沿着假体主体的上面部分延伸。若干通孔形成在肋条内，以便骨骼组织的向内生长。假体元件的可能的取下会造成骨骼的大量损失。在纵向肋条之间的空间可以为切割工具提供一些引导，但是，这些空间的形状不提供保护，以便减小骨骼原质的损失。另外，肋条的每一个外缘都是有齿轮的，并且假体元件的末梢部分具有多个结构，以确保假体元件的固定。因为全部的设计显示了假体元件的目的在于提供确保对股骨的可靠的固定的假体，而假体的容易取下不是EP 181566发明的目的。
已提出了用于锚定无粘固粉的假体元件的若干机构，并且如上所述，有不少是便于它们的撤回的。但是，锚定的越好，撤回的困难越多。而上述假体设计的撤回不可避免地导致骨骼原质的损失，或者使骨骼破裂成两块或多块，或者是二者均有。这种可能性是不希望的。相反地，本发明设法提供避免在撤回时的这种严重复杂化的移植物。
发明概要
本发明的目的在于提供一种假体元件，其具有允许锚定在像骨骼一样的活组织上的构造，并且减小了与假体元件的撤回有关的问题。该目的根据独立权利要求1和在下面的从属权利要求中限定的本发明的实施例而完成。
根据本发明的假体元件可以用于在人或动物体内的各种矫正术的替换。假体元件可以用于骨架重建，用于下肢和上肢的例如髋关节、膝关节、肩关节和肘关节等的较大滑膜关节。或者假体元件可以用作口腔内的移植物。
尽管主要是为人或动物例如狗的人造关节的无粘固粉式固定，或者是作为人造牙齿的锚定装置而进行设计，但是如因其它原因而认为必要的话，移植物可以通过骨骼粘固粉进行固定，除非仅仅为纤维组织的向内生长而设计时(图3)。
假体元件具有给周围的骨骼或纤维组织限定界面的外表面，其中假体元件设有至少一个用于组织生长的内锚定腔和至少一个用于切割工具的引导机构。
用于切割工具的引导元件在US 6,187,012中显示。与该发明相反，提供了这些引导元件，用于引导切割工具在假体元件外部完成切割操作，而用于松开根据本发明的假体元件的切割操作在如上述的假体元件内完成。
在公开于EP 181586中的假体元件的肋条之间的空间可以理解为用于切割工具的引导元件。至于US 6187012的假体元件，EP 181586的假体元件需要从待取下的假体元件的外部来够到。在EP 181586的肋条之间的空间和引导元件没有定位在假体元件内。
根据本发明的假体元件的外表面优选地是光滑的，以便于假体元件的如认为必要的撤回。
假体元件的锚定通过纤维或骨骼组织的向内生长在锚定腔中或二者兼有地进行提供，该锚定腔可以由在假体元件内的任何几何形状的传统的洞或孔构成。然而，与传统的洞或孔相反，锚定腔全部被定向并且连接到一个或多个引导机构上，以便假体周围的组织的锚定在撤回时可以通过适当的切割工具取下。
锚定腔可以由洞，缝，孔道，沟槽，孔或微孔或其它能使组织向内生长到假体元件中的空腔构成。当洞或孔的直径大于0.25mm时，获得了最好的骨骼锚定，并且假体元件是由像钛一样的有利于骨骼向上生长的材料制成。为了排斥骨骼有利于纤维组织向内生长，孔的最大直径优选应小于0.1mm，而假体元件由有利于纤维组织包囊的材料如不锈钢制成。
引导机构和锚定腔基本定位在由假体元件外表面所限定的假体元件的周边/周围内。锚定腔和引导机构是互连的，并且至少一个锚定腔和/或引导机构在外表面中具有开口，用于组织生长到元件中。因此，引导元件和/或锚定腔可以定位在外表面附近或深处。
通过将引导机构定位在假体元件内，以及将引导机构与锚定空腔互连，将能够去除假体元件的组织的切割就基本上在假体元件进行。包围假体元件的骨骼原质因此由于引导机构的定位而提供了改进的保护。与以上引用的现有技术相比，将包围假体元件的骨骼原质去除以达到接近外表面的需要被消除或减小了。因此，当去除根据本发明的假体元件时，骨骼原质的损失将被减少。
引导元件和锚定空腔在假体元件内的定位以及在这两个之间的互连，就产生了好的锚定和容易取下假体元件的可能性的协同效应。
引导机构可以采取各种形状，以满足使切割工具能够去除基本上向内生长的锚定在孔或洞内的组织，而不损害假体周围的组织原质的目的。引导机构可以像凹槽，凹部，中空部，孔道，沟槽或管道等一样的形状，以便插入切割工具。另外，引导机构的横截面可以是球形的、半球形的或采取任何其它的适当的形式。引导机构的横截面的形状和/或尺寸可以是均匀的或沿着引导机构的纵向方向而变化。引导机构例如可以在假体元件的近端部分具有圆形横截面，而在远端部分的横截面稍微多于半圆形(或者就为半圆形)。
在例如近端股骨部件的具有柄部的假体的特定情况下，本发明优选地提供了全部或部分纵向沿着移植物的抛光的柄部的一个或多个引导机构。这些引导机构优选设计成以便像刚性的或尤其是柔性的钻头一样的切割工具不能偏离正道。在这方面，柄部的凸缘还可以设有将钻孔器准确地引导到柄部的引导机构的洞。
锚定腔以与引导机构成一定角度地进行定向，优选地垂直于引导机构。优选地，引导机构在元件的纵向方向上延伸并且锚定腔在元件的横向方向上延伸。在一个实施例中，锚定腔在元件的纵向方向和横向方向上延伸，并且在假体元件的外表面中具有纵向开口。引导机构和锚定腔以及它们的分别在纵向方向和横向方向的延伸部的数量随着各种应用领域的条件而变化。空腔不必从一个引导机构延伸到相对地定位的引导机构。
在本发明的一个实施例中，引导机构定位在元件的外表面附近，每一个引导机构都在外表面中具有一个例如与假体元件的圆周一致的纵向开口。当在引导机构中引导切割工具以用于切割用途时，这可以在某种程度上影响包围假体元件的骨骼原质，这是因为根据该实施例，切割工具没有完全与骨骼原质分开。虽然如此，当应用该实施例时的骨骼原质的损失与现有技术相比显著地减少了。如果必要，切割工具对骨骼原质的碰撞可以通过进一步远离圆周地定位引导元件而减少。
这些引导机构的上端可以是有螺纹的，以便适当的短螺钉可以将它们关闭。有螺纹的部分还可以用于锚定适当的器械以便插入或取下假体。根据一个特定实施例，整个引导机构可以形成为螺纹以便用作固定表面。
根据一个备选实施例，在引导机构之间没有提供空腔。作为替代，在引导机构内的表面或一部分表面可以设有一层多孔材料，以便纤维或骨骼组织的向内生长。
假体元件可以通过传统的机构或者通过像金属印刷方案(MPP)、电子束熔化(EBM)工艺或激光设计的净成形技术(LENS)一样的快速原型和快速制造工艺制成。假体元件的柄部还可以是弯曲的。这当使用柔性的钻孔器时不导致任何问题。
附图简介
图1是具有中间凸缘的近端股骨内假体的示意性侧视图，用于纤维或骨骼组织向内生长在孔或洞内，该孔或洞定向成横向于纵向的在外部打开的用于切割工具的槽或孔道。
图1A和图1B是图1的横截面图。
图2是如图1所示近端股骨的内假体的一种改型的示意性侧视图，用于纤维或骨骼组织向内生长到孔或洞内，该孔或洞延伸完全穿过移植物，朝向用于在移植物的相对侧的切割工具的引导机构。
图2A和图2B是图2的横截面图。
图3是近端股骨的内假体的示意性侧视图。在通过纤维组织仅向内生长来提供锚定的特殊情况下，用于切割工具的圆形引导机构可以位于柄部内。
图3A、图3B和图3C是图3的横截面图。
图4A-图4D是显示了本发明另一实施例的四个视图，图4C和图4D显示了上述的定位。
图5是当使用原则上根据按照图4进行设计的试验性柄部的实施例时的本发明效果的图。
图6是其中引导孔道被多孔层(未依比例绘制)覆盖的另一实施例的截面图。
图7是髋臼杯(acetabular cup)的外壳的示意性侧视图。
图7A是图7的示意性的横截面图。
图8和图9是用于锚定人造牙齿的牙齿移植物的示意性剖视图。
图10是具有弯曲的股骨的柄部的实施例。
本发明的详细描述
尽管本说明书集中在将本发明应用于近端股骨的假体，但是，该本发明同样可应用到其它类型的无粘固粉的或具有粘固粉的假体。也就是说，切割引导机构可以应用到具有不同几何形状的其它类型的装置。
图1显示了近端的模块化类型的股骨的内假体(1)，具有用于球的传统Morse渐缩形上端(2)和渐缩的、抛光的、圆锥形末端(3)。纵向沿着柄部的显示为缝或孔道(6)的若干锚定空腔提供了用于纤维或骨骼组织向内生长的通道。如图所示，锚定空腔可以具有沿着假体的全部长度或沿着一部分长度的纵向延伸部。
用于切割工具的纵向引导机构(5)稍微深入地位于柄部内，通过如图1A-图1B所示的缝(6)向外敞开。
引导机构还可以如图2所示地非常浅表层地设置，其中引导机构(5)的横截面形状优选地稍大于半圆形，以便阻止切割工具偏离正道。
图中仅显示了中间的凸缘(4)。在提供了完整环形的凸缘的情况下，对于近端的负载转换，引导机构完全通过凸缘，并且这种凸缘不会因此而阻碍假体的可控撤回。
如图2A和图2B所示，组织直接生长到引导机构(5)中是可能的，或者可能如图1A所示通过缝(6)生长到引导机构(5)中。最重要的是，通过组织在与引导机构(5)横向互连的孔、洞或小的沟槽(7)内生长，或者在从一个引导机构到在移植物(图2A-图2B和图4)的另一侧的一个引导机构地延伸完全通过移植物的洞或孔内生长，或者在这二者内生长，来提供进一步的锚定。
引导机构的最上端可以具有螺纹，以便适当的短螺钉可以关闭引导。有螺纹的部分(5a)的示例在图2中所示。有螺纹的部分(5a)还可以用于锚定适当的器械，以便插入或取下假体，或用于钻头引导。
为了促进骨骼向内生长在引导机构(5)中，并且尤其进入锚定洞或孔(7)内，它们可以涂以促进组织向上生长的像羟基磷灰石一样的材料，或者如1990年的发明人为Einar Sudmann等人的US 4,913,903中所介绍的维持药物释放物质。
如上所述，假体元件可以通过组织向内生长而锚定到活组织上。通过骨骼或纤维组织的锚定仅会对患者产生最为长期的结果，但是这必须被确定。然而，在人和动物体内非常好的锚定“移植物”牙齿是被纤维组织锚定的，被多个小的胶原纤维锚定的。而且这种仅通过纤维组织的锚定已经受了数百万年的试验。
图3显示了用于纤维组织锚定的假体移植物。如上所述，为了阻止骨骼组织向内生长，用于纤维组织锚定的孔优选地应具有小于0.1mm的最大直径。图3中的孔(8)因此未依比例绘制。必要的部分在于，孔与用于切割工具的引导机构(5)垂直(图3A-图3B)或以任何角度地定向。每一个孔或洞(8)的外部开口都可以指向作为微型切割装置的远端周边(9)，该微型切割装置在撤回时切割其内的向内生长的组织(图3C，图8-图9)。图3A显示了连接于每一个引导机构上的多个孔/洞的示例。在假体元件的左边部分，引导机构(5)连接于从假体元件的一侧延伸到另一侧的通孔(8)，而在假体元件的右边部分在垂直于厚度方向的方向上提供了另外的洞。同样，技术人员应明白洞(8)的构造可以以各种方式完成。
图4A-图4D介绍了本发明的另外实施例。股骨的半假体(用于动物)的示意图原则上是与图2的实施例相同的类型，但是在每一侧上仅有一个引导机构。在引导机构之间提供了空腔或通孔7。假体元件的凸缘4具有特别的设计。上部具有一定厚度并且设有终止于各自的引导机构或沟槽5的洞9。当元件1将被取下时，钻孔器10插入洞9内，并且钻孔器如图4D所示地在空腔7内切割锚定组织。然后，元件可以分离。
图5显示了本发明的效果。图表中的上部曲线(A)显示了用于推出/抽出试验假体元件所必要的载荷，而下部曲线(B)显示了经根据本发明的处理之后所需的显著减小的载荷。
另一个实施例在图6中说明。例如如图2或图4所示的构造可以构造成无空腔7。作为备选，引导机构5的至少一部分内表面设有适于骨骼或纤维组织向内生长的层11。层具有相通的孔并且可以具有500μm的厚度。孔的尺寸应是小的，例如小于100μm，如果仅希望纤维组织的向内生长。
这样，有可能通过骨骼和/或纤维组织达到好的锚定，而在厚的元件内没有从一侧到另一侧的通孔。
图7显示了用于髋关节的衬垫可以如何进行设计。用于柔性切割器械的引导机构(5)从圆顶向周围扩展，并且锚定孔或洞(7)互连这些引导机构，或者完全通过外壳。
图8显示了用于人造牙齿的底部的牙齿移植物。如上所述，锚定通过骨骼或纤维组织或这二者固定在朝向用于切割装置的纵向引导机构(5)开口的洞或孔(7)内。移植物可以为如图所示的圆形或任何需要的形状。表面是经过抛光的，并且为了初步固定在钳口内，圆形移植物可以像螺钉一样地形成。
图9显示了用于人造牙齿的底部的牙齿移植物。然而，锚定此时通过纤维组织在如图3所示的孔(8)内向内生长而提供。移植物可以为如图所示的圆形或任何需要的形状。表面是经过抛光的，并且为了初步固定在钳口内，圆形移植物可以像螺钉一样地形成。
图10中显示了具有弯曲的假体元件(3)的一个实施例。引导机构的上部像如图2所示的一样地为螺纹(5a)。在该实施例中，必须使用柔性的钻孔器。
在像膝关节或踝关节假体一样的移植物内的锚定钉可以如图8-图9所示地进行设计。这些钉的横截面可以为圆锥形，圆形，椭圆形，或者处于这些形状之间的任何形状。为了接近凸起部件如股骨的钉中的引导机构(5)，去除移植物的预成型的变弱部可能是必要的。
在本发明范围内的许多变更都是可能的。引导机构和空腔的构造以及它们的关系可以更改。然而，上述的纵向螺纹引导机构或孔道将适合于通过骨骼组织仅向上生长的锚定，而不是通过纤维组织。柄部可以是平直的或者是如图所示的圆锥形，但是本发明还适合于使用柔性钻孔器的弯曲柄部。

Claims (16)

1.一种假体元件，具有为周围的骨骼或纤维组织限定了界面的外表面，其中，所述假体元件设有至少一个用于组织生长的内锚定腔和至少一个用于切割工具的引导机构，
其特征在于，
所述引导机构和所述锚定腔基本上定位在由所述假体元件的所述外表面限定的所述假体元件的周边/周围内，其中，所述锚定腔和所述引导机构是互连的，并且所述锚定腔和/或所述引导机构中的至少一个在所述外表面内具有开口，以便组织生长到所述元件内。
2.根据权利要求1所述的假体元件，其特征在于，所述引导机构是由凹部、凹槽、中空部、孔道、管道或沟槽构成。
3.根据权利要求1或2所述的假体元件，其特征在于，锚定腔由孔、洞、缝、孔道、沟槽或具有小于0.1mm的最大直径的孔形成。
4.根据权利要求1-3中任一项所述的假体元件，其特征在于，所述锚定腔是在至少部分地覆盖了引导机构内表面的表面层中的孔。
5.根据权利要求1-4中的任一项所述的假体元件，其特征在于，所述锚定腔定向成与所述引导机构之间形成一定的角度，优选垂直于所述引导机构。
6.根据权利要求1-5中的任一项所述的假体元件，其特征在于，所述引导机构在所述元件的纵向方向上延伸，并且所述锚定腔在所述元件的横向方向上延伸。
7.根据权利要求1-6中的任一项所述的假体元件，其特征在于，所述锚定腔在所述元件的纵向方向和横向方向上延伸，并且每一个所述锚定腔在所述假体元件的所述外表面中具有纵向开口。
8.根据权利要求1-7中的任一项所述的假体元件，其特征在于，所述引导机构定位在所述元件的所述外表面附近，其中每一个引导机构在所述外表面中具有纵向开口。
9.根据权利要求1-8中的任一项所述的假体元件，其特征在于，所述外表面是光滑的。
10.根据权利要求1-9中的任一项所述的假体元件，其特征在于，所述引导机构至少在所述元件的近端部分中具有至少半圆形的横截面。
11.根据权利要求1-10中的任一项所述的假体元件，其特征在于，所述引导机构和/或所述锚定腔的横截面沿着纵向方向是均匀的或不均匀的。
12.根据权利要求1-11中的任一项所述的假体元件，其特征在于，至少一个锚定洞在所述假体元件的所述外表面附近设有尖锐的结构，所述尖锐的结构具有切割装置的功能。
13.根据权利要求1-12中的任一项所述的假体元件，其特征在于，所述引导机构的上端是带螺纹的。
14.根据权利要求1-13中的任一项所述的假体元件，其特征在于，所述引导机构的至少大部分是带螺纹的。
15.根据权利要求1-14中的任一项所述的假体元件，其特征在于，所述引导机构是位于所述元件两侧的沟槽，所述沟槽具有在两侧连接所述沟槽的腔洞，并且在所述元件上端的凸缘设有通向各自沟槽的贯通孔。
16.根据权利要求1-15中的任一项所述的假体元件，其特征在于，所述假体元件用于：
-骨架重建；
-用于下肢和上肢的较大滑膜关节，例如髋关节，膝关节，肩关节和肘关节；
-口腔内的移植物。
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