CN1980615A - 用于关节假体的无接合剂锚固的双壳体植入件 - Google Patents

用于关节假体的无接合剂锚固的双壳体植入件 Download PDF

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CN1980615A
CN1980615A CNA2005800097364A CN200580009736A CN1980615A CN 1980615 A CN1980615 A CN 1980615A CN A2005800097364 A CNA2005800097364 A CN A2005800097364A CN 200580009736 A CN200580009736 A CN 200580009736A CN 1980615 A CN1980615 A CN 1980615A
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S·泰皮克
H·马尔肖
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SCYON ORTHOPAEDICS AG
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2002/3605—Femoral heads ; Femoral endoprostheses for replacing only the epiphyseal or metaphyseal parts of the femur, e.g. endoprosthetic femoral heads or necks directly fixed to the natural femur by internal fixation devices implanted without ablation of the whole natural femoral head made of two or more concentric caps fitted onto one another
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Abstract

本发明解决了通过薄的、优选是纯钛或钛基合金的、穿孔的并因此对液体开口的壳体(1；13)(该壳体与第二、未穿孔的壳体(2；14)隔开)而将假体部件锚固在柔顺、松质骨中的问题。在大部分用途中，由***的解剖学位置来确定，壳体为近似半球形形状，在赤道线上相互连接。固体壳体可以包括关节的另一铰接部件，例如聚合物或陶瓷***件，或者它自身可以起到该功能。可以根据本发明来锚固关节假体的一个或两个部件。

Description

用于关节假体的无接合剂锚固的双壳体植入件
技术领域
本发明涉及一种用于整个或部分关节假体的骨锚固部件，例如整个髋假体的髋臼杯或者用于髋关节的股骨头部的表面重修假体。它解决了通过薄的、优选是纯钛或基于钛的合金的、穿孔并因此对液体开口的壳体(该壳体与第二、未穿孔的壳体隔开)而将假体部件锚固在柔顺、松质骨中的问题。在大部分用途中，由***的解剖学位置来确定，壳体为近似半球形形状，在赤道线上相互连接。固体壳体可以包括关节的另一铰接部件，例如聚合物或陶瓷***件，或者它自身可以起到该功能。
US3905777的图4B公开了一种复合植入件壳体，该复合植入件壳体具有内层和穿孔的外层，且在它们之间没有间隙。EP0230006示出了一种扁平骨植入件，该扁平骨植入件有由网格覆盖的芯，该网格通过多个间隔物而与芯表面隔开。US5380328公开了一种扁平复合植入件结构，它有两个穿孔的钛板，多孔隔膜夹在它们之间。
背景技术
在关节替代设计中的主要目的和困难是使得假体部件快速和非常稳定地锚固，该假体部件用作运动对，以便代替自然的关节，该自然的关节例如由于软骨退化疾病而失去了它的功能。在一些情况下，自然关节的一侧仍然处于相对良好状态，而部分或一半假体能够恢复无痛功能。
通常，该目的需要解决两个部分相连的问题：(i)在骨植入交界面处的引起负载的运动；(ii)骨的应力屏蔽，特别是通过普通的刚性固体金属或金属支持部件。在Charnley类型的全髋骨更换(THR)中的骨接合剂通过就地聚合互锁来实现交界面的稳定性。在锚固在管形皮层骨中的有柄部件(例如THR的普通股骨部件)的情况下，骨接合剂也提供柔顺的覆盖层，这能够更均匀地分布负载，并因此减小应力屏蔽的效果，同时还减小了交界面剪切应力和产生微运动的危险。
所有这些在短时间内都好，但是当较长时间时就不令人满意-无菌松弛是THR的长期失效的最通常的原因。通过分析和仔细观察，认为接合剂覆盖层的疲劳失效是导致无菌松弛的过程的一个通常和重要的因素。这是后来发展无接合剂THR的主要驱动力，但是，所有不同类型的广泛测试和大量的后续实验的临床性能仍然比良好设计和良好接合剂接合THR(Malchau H，Herberts P等，Prognosis of TotalHip Replacement，Update and Validation of Results from the SwedishNational Hip Arthroplasty Registry 1979-1998，Scientific Exhibition，AAOS，2000，Orlando，USA)的临床性能差。在大部分情况下，无接合剂假体通过将更多刚性金属添加在已经刚性的芯元件上而代替柔软接合剂覆盖层。这加剧了以下两个问题：刚性上的更大的不匹配导致更明显的应力屏蔽；而且，在交界面处的剪切负载更高，因此增加了微运动的危险。
本发明解决了通过薄的、优选是纯钛或钛基合金的、穿孔并因此对液体开口的壳体(该壳体与第二、未穿孔的壳体隔开)而将假体部件锚固在柔顺的松质骨中的问题。在大部分用途中，由***的解剖学位置来确定，壳体为近似半球形形状，在赤道线上相互连接。固体壳体可以包括关节的另一铰接部件，例如聚合物或陶瓷***件，或者它自身可以起到该功能。关节假体的一个或两个部件可以根据本发明来锚固。
THR的髋臼杯-本发明的优选实施例
将髋臼杯锚固在骨盆骨中的一个难题是通过骨的向内生长而快速结合，这需要机械稳定性，而且要避免柔顺性上的较大不匹配。骨盆骨形成用于髋臼的非常柔顺的支承结构，因此，软骨层覆盖较硬的软骨下骨(由软的松质骨支持)的壳。松质骨的杨氏模量为大约100MPa-这比致密皮层骨低一百倍，比钛低一千倍。即使聚合物材料例如UHMWPE或基于PMMA的骨接合剂也硬得多。
在普通的无接合剂髋臼部件中，软骨下的壳被设计成完全被除去以便骨向内生长，或者在各种螺旋型设计中被局部保留。金属支持物通常为非常硬的结构，从而导致柔顺性很不匹配，且大大减少了完全、耐久的骨结合的可能性。由Sulzer Orthopaedics发展的线网支持的聚合物髋臼杯和Zimmer的金属泡支持物(由Implex Corp.开发)都示例表示了为解决柔顺性不匹配问题而作出的努力。
在大部分情况下，支持在骨上的金属支持物有粗糙表面，有时有相互连接的孔，这些孔伸入材料内一定深度，但是终止于封闭的盲端孔。利用骨生长和重塑时的对流输送作用，我们的首要任务是提出对液体开口的植入件的概念。
用于聚乙烯(通常是超高分子量聚乙烯，UHMWPE)***件的双壳体的金属支持物(metal-backing)的固体内部壳体悬在致密的穿孔的外部壳体内，从而在外部壳体的内壁和内部壳体的外壁之间留下了大约一毫米的自由空间，即骨自由地经过外部穿孔壳体而生长至该空间内。通过对流流体流(通过由骨的生理学负载引起的循环压力梯度而产生的运动)而加速骨的向内生长。而且，结构的弹性将导致流体在髋骨的动态负载作用下被泵入和泵出骨床以及被泵入和泵出穿孔壳体。它的主要功能不同于由Sutter发展的穿孔柱形植入件，该穿孔柱形植入件主要用于牙齿(Vuillemin T，Raveh J，Sutter F，MandibularReconstruction with the Titanium Hollow Screw Reconstruction Plate(THORP)System：Evaluation of 62 Cases，Plast Resonstr Surg，82(5)：804-14，1988)，也用于矫形术(WO85/02535)。在本发明中，流体对流增加了由包围植入件的尚存的松质骨发出的重要骨生长促进素的质量输送。
外部穿孔壳体的表面还可以通过已知的用于加强结合的方法来进行处理，例如粗糙喷砂，或者通过钛或羟磷灰石来进行等离子体涂覆。这可以提高所谓的微互锁。
为了增强用于初始稳定的压配合，外部壳体还可以包括恰好在“赤道”下面沿周向延伸的小凸起。壳体的“极点”可以稍微削平，以避免杯在“极点”处降至最低点，从而不能在“赤道”处充分接合。这些附加特征在髋臼杯设计领域中是已知的，并已经显示了它们的临床优点。
用于THR的双壳体髋臼杯的详细说明
附图说明
图1是从后侧看时髋臼杯的透视图，其中，对两个壳体进行局部剖；
图2是从前侧看时髋臼杯的透视图；
图3是髋臼杯的剖视图；
图4是对着骨且由骨向内生长的壳体的剖视图；
图5是股骨头部的表面重修假体的剖视图；
图6是整个髋关节假体的视图，其中有根据本发明锚固的两个部件。
图1中的髋臼杯100的、对着骨的外部壳体1被密集穿孔，并在赤道面4处与内部的无孔壳体2连接。这可以通过压配合和/或焊接这两个部件而实现。当装配后，两个壳体将隔开一定间隙5(图3)，该间隙5允许骨通过孔6经过外部壳体1而自由生长。由可机械加工性和强度的机械要求、制造的经济性以及与典型尺度的松质骨交接而确定的典型尺寸是：外部和内部壳体的厚度都为一毫米，在两个壳体之间的间隙为一毫米，且孔的直径为一毫米。当然，这些图只是基本表示了比例，并需要适当调节成髋臼的尺寸。例如，对于54mm直径的杯，最终尺寸选择为：两个壳体的厚度为1.2mm，间隙为1mm，孔的直径为1.2mm，而孔间距为2mm。
外部穿孔壳体1和内部无孔壳体2优选是由纯钛制造。也可以使用钛基合金，这时壳体的强度可能是个问题。杯的衬垫3(通常由聚乙烯UHMWPE制造)***内部壳体2中，这里优选是也通过在赤道面4(图1)处进行压配合。可选择地，聚乙烯衬垫可以支承用于陶瓷-陶瓷关节对的第二陶瓷衬垫。该衬垫能够形成对着股骨部件头部的低摩擦关节，该股骨部件通常由铬基合金或陶瓷来制造。
当将杯压配合装入扩孔的髋臼内时，在杯的赤道面上的肋凸起7(图3)可以用于增加机械稳定性。杯8的极点最好稍微削平，以避免杯降至最低点(bottom out)-大部分常用的扩孔器为半球形，且当杯也为完全半球形时，可能损害在赤道处的配合。
在杯周边的凹口9将容纳辅助螺钉的头部(当需要使用它们时)-这可能在形成较差或变形的髋臼中(将防止在赤道处的牢固压配合)出现。这时，螺钉应当恰好切向地布置在杯上，且它们的合适形状的头部卡住杯的轮缘。
图4是对着松质骨床10的双壳体植入件的示意图。在动负载下，当外部穿孔壳体1推至尚存的骨10上时，将迫使流体透过所有的骨出来，然后被吸收回骨内，如箭头11所示，从而将来自骨的骨生长刺激物质通过孔6输送至分开壳体1和2的间隙5中。这导致骨快速向外壳1内生长，如箭头12所示。且内部的无孔壳体2使得UHMWPE衬垫3不会与新近形成的骨进行任何接触。在机械方面，向外部壳体内生长将模拟自然髋臼的已经除去的软骨下骨组织，而不会有对支承松质骨的明显的应力屏蔽。
股骨头部的表面重修假体
通过颠倒顺序，即通过将穿孔的、朝向骨的壳体13布置在无穿孔壳体14的内部，可以进行相同原理的固定，用于股骨头部的表面重修(图5)。实际上，这里的应力屏蔽是对使用该细微侵入技术的一系列限制，因为所有已知的表面重修杯为固体、刚性的植入件，该植入件既可结合在向下扩孔的股骨头部上，或者进行压配合，以便用于无接合剂固定。
这时，外部壳体14优选是由铬基合金制造，或者由钛合金制造，头部涂覆有例如“氮化钛”或离子植入件，以便增加磨损阻力。
在本发明的另一实施例中，假体的两个部件能够通过使用双壳体原理而锚固(图6)。

Claims (17)

1.一种假体部件，用于无接合剂地结合至骨中，它包括两个隔开的壳体(1、2；13、14)，其中，对着骨的壳体(1；13)进行穿孔，以便使骨能够快速向内生长。
2.一种关节假体，其中，一个部件通过如权利要求1所述的双壳体(1、2)来锚固。
3.一种关节假体，其中，两个部件都通过如权利要求1所述的双壳体(1、2)来锚固。
4.根据权利要求1所述的用于整个髋假体的髋臼杯，其中，外部穿孔壳体(1)为近似半球形，并在赤道面(4)处与内部无孔壳体(2)连接。
5.根据权利要求1至3中任意一个所述的假体部件以及特别是根据权利要求4所述的髋臼杯，其中：壳体(1、2)由钛或钛基合金制成。
6.根据权利要求1至5所述的假体部件，特别是髋臼杯，其中：外部穿孔壳体(1)的厚度在从0.7至1.5mm的范围内，优选是大约1mm。
7.根据权利要求1至6所述的假体部件，特别是髋臼杯，其中：在外部壳体和内部壳体(1、2)之间的空间(5)在0.5至2mm的范围内，优选是大约1mm。
8.根据权利要求1至7所述的髋臼杯假体，其中：内部无孔壳体(2)包括衬垫(3)，用于低摩擦地铰接在整个髋假体的股骨部分(1)上。
9.根据权利要求1所述的用于股骨头部的表面重修假体，其中：两个壳体布置成使得对着骨的穿孔壳体(13)在外部壳体(14)的内部，该外部壳体(14)铰接在髋臼上，这两个壳体在赤道面上连接并隔开，以便允许骨向内生长。
10.根据权利要求1所述的假体部件，其中：对着骨的穿孔壳体(1)和外部壳体(2)相互装配，且在它们之间留下连续间隙(5)。
11.根据权利要求1所述的假体部件，其中：对着骨的穿孔壳体(1)由固体材料制成，并在它们的周边之间进行自支承。
12.根据权利要求1所述的假体部件，其中：在隔开的壳体(1、2)之间形成的间隙(5)沿用于骨向内生长的任意方向在壳体(1、2)的周边之间自由延伸。
13.根据权利要求1所述的假体部件，其中：隔开的壳体(1、2)只在它们的周边处相互接触。
14.根据权利要求1所述的假体部件，其中：隔开的壳体(1、2)形成为同心杯。
15.根据权利要求1所述的假体部件，其中：对着骨的穿孔壳体(1)由穿孔的单个片材制成。
16.根据权利要求1所述的假体部件，其中：对着骨的穿孔壳体(1)的厚度与孔直径的比例在0.5和2之间，优选是大约1。
17.根据权利要求1所述的假体部件，其中：在相邻孔(6)之间的中心到中心的距离大于孔直径，优选是1.2至2倍，更优选是大约1.7倍。
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