CN1331574A - 一种假体构件 - Google Patents

一种假体构件 Download PDF

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CN1331574A
CN1331574A CN99814923A CN99814923A CN1331574A CN 1331574 A CN1331574 A CN 1331574A CN 99814923 A CN99814923 A CN 99814923A CN 99814923 A CN99814923 A CN 99814923A CN 1331574 A CN1331574 A CN 1331574A
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prosthesis structure
joint
fixture
composition surface
prosthesis
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CN1178630C (zh
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M·雅各布松
S·温贝里
L·卡尔松
T·雷斯特伦德
B·阿尔布雷克特松
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Astra Tech AB
AstraZeneca AB
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Abstract

一种假体构件(1),用于锚固于人体或动物体中关节的关节部(11)的关节端,该假体构件包括:一接合件(3),该接合件具有一用于与设置在所述关节端的互补关节端表面(14)接合的平的或大致平的接合表面(3b);以及一细长形固定件(4),其被连接至接合面且与接合面相间置,以便插入距所述关节端表面(14)一定距离处设置在所述关节端的一互补孔(12)内。细长形固定件(4)与接合表面(3b)形成一个锐角(β)。

Description

一种假体构件
本发明涉及一种假体构件，其锚固于人体或动物体中一个关节的关节部的关节端，该假体构件包括：一接合件，该接合件具有一用于与设置在关节端的互补关节端表面接合的平的或大致平的接合表面；及一细长形固定件，其被连接至接合面且与接合面间置，以便被插入距所述关节端表面一定距离处设置在所述关节端的一互补孔内(一种“限定型式的假体”)。
由以前的专利申请公开文件FR-A-26300639(LeBeguec)及WO93/22990(Astra AB)已知限定型式的假体构件被用于人体构件的外科手术，并且其中已知的假体构件用于分别锚固于人的胫骨或股骨的膝关节端部上。在FR-A-26300639及WO93/22990的假体构件中，使固定件的纵向轴线平行于接合面设置。在此处可参考使用的WO93/22990(Astra AB)还披露了使所述固定件以与在构件的延长或前侧和构件的弯曲或后侧之间延伸的膝关节的主关节平面成一定角度地进行定位。
本发明的目的在于修改细长形固定件和限定型式假体的接合面之间的关系，以便改进假体构件的锚固能力。
本发明的提供了一种如此型式的假体构件，其中细长形固定件与接合面形成一个锐角。因此，通过设置具有一纵向轴线的孔，所述纵向轴线沿预定插入方向、以几乎对应于在细长固定件和接合面之间形成的角度的锐角倾斜地远离开关节端表面，可将细长固定件以预定的插入方向插入所述孔内，以便通过由离接合面最远的细长形固定件之端部导引，该细长形表面能够逐步接近所述关节端表面。另外，以彼此相距相当于接合表面和细长固定件间之距离的间距可形成所述孔和关节端表面，以此使假体构件的接合面在离最终锚固位置不远的中间插入位置处与关节端表面形成一初始接触。结果，将通过楔形压迫效应阻碍假体构件朝最终锚固位置的进一步移动，从而必须大致平行于关节端的方向、强迫假体构件从中间插入位置移动以达到最终锚固位置。因此，在骨和假体构件之间获得一压入配合和预应力，因此使被锚固的假体构件具有较高的转动和侧向稳定性。因此，在不使用螺钉和螺栓这样的其它紧固装置的情况下，便可实现假体构件良好地锚固于关节端部上。
细长形固定件和接合面之间的锐角优选在1°-5°的范围内，且该角度范围在1°-3°的范围内特别理想。
在如后文所述的本发明的一个实施例中，该细长形固定件为第一细长形固定件且假体构件包括一个或更多其它的细长形固定件，所述固定件被连接至接合面且与之间置，以便插入距所述关节端表面一定距离处设置在关节端的一互补孔内，每一其它的细长形固定件以与接合面成一锐角地倾斜配置且大致平行于第一细长固定件延伸。
每一固定件可通过一个或多个肋状元件被连接至接合面上。
在如后文所述的本发明的一个实施例中，每一固定件的插入端部均具有一缩小的横剖面。其是通过斜切该朝向接合面之侧部上的插入端部来实现的，在这种装置情况下，斜切该插入端部之程度最好应使该插入端部之面向接合面的侧面与固定件之剩余部分的对应侧边(母线)形成的夹角在1°-4°范围内，且角为大约2°是特别理想的。
在如后文所述的本发明的一个实施例中，接合表面设有一个或多个骨组织接收腔，它们在将假体构件锚固于关节端时，适于接收关节端表面的骨组织。骨组织接收腔可包括一个或多个形成在接合表面上的纵向沟槽，所述纵向沟槽沿大致每一固定件的方向延伸。
在如后文所述的本发明的一个实施例中，该或每一细长的固定件均以与该相反对应侧延伸的总体方向成一倾斜角度地在接合元件的相反对应侧之间延伸。
该或每一固定件均可具有一个平滑连续的周表面。另外，该或每一固定件可设置如上文WO93/22990所描述的轴向延伸的键槽。
在本发明的一个实施例中，当锚固假体组件时，接触骨组织的假体构件的一个或多个表面需接受增强骨整合(osseointegration)的表面处理。作为一个例子，可采用骨接触表面的喷射处理。
为了方便起见，接合元件和每一固定件可形成一体件。
在如后文所述的本发明的一个实施例中，假体构件为一关节假体组件的锚固元件部分，用于使所述关节中关节部分的关节端进行局部或整体移位。为此，接合件可以是一种板状件，其具有一形成接合表面的第一主表面及一用于支承关节组件中其它元件的第二相反对应的主表面。
在如后文所述的本发明的一个实施例中，假体构件适于锚固于人体或动物关节中一个关节部分的关节端上。
现在通过例子，参照附图对本发明的实施例进行说明，其中：
图1为一膝关节假体组件的透视图，该组件包括一本发明第一实施例的假体构件，该假体构件包括一板状接合件，从该接合件垂挂两根杆状的具有一斜切端的固定件。
图2为图1中膝关节假体组件的透视侧视图，
图3为图1中膝关节假体组件的假体构件的底部平面图。
图4为图1中膝关节假体组件的假体构件的侧面正视图。
图5a为图1中图1中膝关节假体组件的假体构件的局部横剖面侧视图，在胫骨的髁端将其装配在被处理骨组织期间，该组件位于中间插入位置。
图5b为沿图5a中箭头A的方向的视图。
图5c为为沿图5a中箭头A的总体方向的剖开透视图。
图6a为在胫骨髁端处完全插入并锚固位置的图1中膝关节假体组件之假体构件的局部横剖面侧视图。
图6b为沿图5a中箭头b的方向的视图。
图6c为沿图6a中箭头B的总体方向的局部剖开透视图。
图7为用于本发明第二实施例的膝关节假体组件之假体构件的局部横剖面侧视图，除了杆状固定件的端部未被斜切以外，该实施例对应于图1-6中的第一实施例。
在所绘制的附图中，在两个实施例中利用相同的标号表示相同的部件。
图1-4描述了一种用于膝关节的胫骨侧的双髁膝关节假体组件2，根据本发明，其包括一个假体构件或固定部件1，其用于锚固于胫骨的膝关节端。
假体构件1为由钛制成的一整体件，且由于在胫骨膝关节端处的髁的非对称性，因此包括一个非对称形式的板状接合件3。接合件3具有一平的上部表面3a和一平的下部接合表面3b，以便与通过切除髁部分形成在胫骨的膝关节端上的互补骨组织表面相接合，如下文将更详细说明的那样。
假体构件1还包括第一和第二细长形、平行的杆状固定件4，5，用于以前后方向、以在由髁部分的切除形成的骨组织表面下方的一定距离处滑动地插入到在胫骨之膝关节端的前部侧和后部侧之间钻制的互补孔内，如下文将更详细说明的那样。第一和第二固定件4，5具有一平滑、连续的圆周表面且由第一和第二肋条6，7以间距地被连接至板状接合件3的接合面3b上。
并且，如图4所示，第一和第二杆状固定件4，5中的每一个均与接合面3b形成一个锐角β，其意味着每一个固定件均具有一个与另一端(“后端”)相比、距离接合面更远的一端(“前端”)。在第一和第二固定件4，5和接合面3b之间形成的锐角β在1°-5°的范围内，最好为大约2°。
如图2所示，第一固定件4的前端由一前端部分4a表示，由于前端部在朝向接合面3b的上侧被斜切，因此前端部分具有缩小的横剖面。前端部分4a的斜切上侧面与第一固定件4的中部4b之对应的上侧边和表现为其后端的第一固定件4的后端部4c形成一夹角δ。前端部4a的斜切上侧面与第一固定件4的中部和后端部4b，4c的相应上侧边(母线)形成一夹角δ，角δ在1°-4°的范围内，最好为大约2°。虽未示出，但是第二固定件5具有一相应的斜切前端部分。
参照图1和2，第一和第二固定件4，5的后端设有插孔，用于接收外科工具，例如通过斜切前端部的导引使第一和第二固定件4，5滑入互补孔12，13的插入工具。
如图3中能最清楚所示那样，下部接合面3b设有呈纵向槽形式的骨组织接收腔6a，6b，7a，7b，它们在肋状元件6，7的两侧、大致以第一和第二固定件4，5的方向延伸。作为替代，也可使骨组织接收腔6a，6b，7a，7b从接合面3b成台阶式或倾斜上升，在下文将对它们的作用进行说明。
如图1和2所示，膝关节假体组件2还包括一铰接件8，其位于板状接合件3的上表面3a，用于支承膝关节的胫骨髁部或锚固于膝关节股骨侧上的膝关节假体组件的一辅助铰接件。铰接件8包括一装配在接合面3b上的支承板9和一装配在支承板9上的滑动件10。板状件3的上表面3a和支承板9的下表面应适于使支承板9稳定地保持在上表面3a或允许支承板9横过上表面3a进行特定但有限的运动。支承板9可由铬/钴合金，铬/钴/.钼合金或陶瓷材料制成。滑动件10可由人超高分子量聚乙烯这样的耐用塑料材料制成。
在进行用于植入膝关节假体组件2的手术之前，患者将经受手术前的x射线分析和计划阶段，以确定允许假体组件2的元件尺寸的正确选择所需的测量和参数。随后，可利用与上文WO93/22990中披露的大致相同的作业进行所述植入操作。可在一阶段操作中实现植入。
如图5a-5c中所示，以前后方向穿过胫骨11的膝关节端钻出第一和第二孔12，13。第一孔12的前端由12a表示，后端由12b表示。第一和第二孔12，13的直径应使它们几乎与第一和第二固定件4，5的直径一致。通过偏离胫骨11的膝关节端之末端的第一和第二孔12，13使第一和第二孔12，13处于相对健康的骨头中，从而当被插入第一和第二孔12，13时，能起到进一步促进第一和第二固定件4，5的骨整合(osseointegration)的作用。第一和第二固定件4，5的骨整合能力(osseointegratability)可由对其表面的粗糙化处理或使其表面具有某种结构，例如通过喷砂来进一步加强。也可对接合面3b施加相同的表面扩大处理，以促进该表面的骨整合能力。
在钻孔作业后，切除胫骨11的髁部分以提供一骨表面14，该表面具有与接合面3b互补的形状，如图5c所示。当患者直立以支承膝关节的功能性运动时，通常该被切削的骨表面14沿前后方向相对水平方向倾斜。被切削的骨表面14相对水平方面的倾斜角度在2°-9°的范围内，最好为大约6°。参照附图5b，在被切削的骨表面14和第一和第二孔12，13之间分别设置第一和第二缝槽15，16，以便在第一和第二固定件4，5插入第一和第二孔12，13时，第一和第二肋状件6和7能够通过。
如图5a所示，第一和第二孔12，13均与被切削的骨表面14形成一角度，该角度对应于第一和第二杆状固定件4，5中每一根杆与平的接合面3b之间的夹角β，第一和第二孔12，13的角度应能使第一和第二孔12，13的后端比前端距离被切削的骨表面14更远。为此，当以前后方向将第一和第二固定件4，5插入第一和第二孔12，13内时，假体构件1的接合面3b将逐步接近被切削的骨表面14。
由图3应注意到，第一和第二固定件4，5以与该相反对应侧延伸的总体方向成一倾斜角度地在板状接合件3的相反对应侧之间延伸。如图5c所示，第一和第二孔12，13在胫骨的前侧和后侧11a，11b之间相应地倾斜，从而使第一和第二固定件4，5与膝关节的一个主关节平面P形成一个夹角α，当将第一和第二固定件12，13插入第一和第二孔12，13时，所述主关节面P在胫骨11的前侧和后侧11a，11b之间大致垂直地延伸。与膝关节的主关节面P的夹角α在10°-45°的范围内，最好为大约20°。
考虑到第一和第二固定件4，5与主关节面P成夹角α地被插入胫骨11内，因此应使第一和第二固定件4，5具有不同的长度，以便(i)第一和第二固定件4，5能大致同时进入第一和第二孔12，13的前端，(ii)大致同时从第一和第二孔12，13的后端露出，且(iii)最好在假体构件1的最终锚固位置处不从第一和第二孔12，13的前端伸出。
图4显示了第一固定件4的前端部4a以预定间距D2与板状接合件3的接合面3b相间置。另外，对于第二固定件5来说也是这样的(未示出)。现参照附图5a，能清楚地看到相对于被切削的骨表面14对第一和第二孔12，13进行定位，以便在第一和第二孔12，13的前端和后端之间的中间位置以预定间距D1与被切削的骨表面14相间置，所述间距D1等于接合面3b与第一和第二杆状固定件4，5的前端部之间的间距D2。这一尺寸的结果是使假体构件1中接合件3的接合面3b在离最终锚固位置不远的中间插入位置处与被切削的骨表面14形成初始的接触。
在图5a-c中显示了假体构件1的中间插入位置，从这些图中将会了解到由于被切削的骨表面14以预定间距D3与第一和第二孔12，13的后端相间置，其中因第一和第二孔12，13以一角度倾斜于被切削的骨表面14，因此所述预定间距D3大于预定间距D2，所以假体构件1从中间插入位置至在图6a-c中所示的最终锚固位置的运动将会受到楔形压迫效应的阻碍。预定间距D3和D2之间的差值一般在0.1mm-0.9mm的范围内，且该差值为大约0.35mm时较为理想。作为一个例子，预定间距D3可为大约10mm。从前边的描述中将会了解到，必须使假体构件1以基本上平行于被切削的骨表面14的方向从中间插入位置强行移动，以达到图6a-c所说明的最终锚固位置，从而克服楔形压迫效应。
如图6a-c所说明的那样，当迫使假体构件1从中间插入位置移动至最终锚固位置时，楔形压迫效应会导致骨组织从被切削的骨表面14挤入在接合件3的接合面3b中的骨组织接收腔6a，6b，7a，7b内。此外，楔形压迫效应会导致被切削的骨表面14压靠在接合面3b上。这样在接合面3b和被切削的骨表面14以及第一和第二杆状固定件4，5的上侧和第一和第二孔12，13中的骨组织之间会产生一预应力，为此，仅通过一压入配合和预应力，即无需使用如螺钉和螺栓这样的其它紧固件便可将假体构件1锚固于胫骨11中。由于所述的楔形压迫效应，假体构件1在最终锚固位置也具有较高的转动和侧向稳定性。
通过图7所示的实施例说明了斜削该第一和第二固定件4，5的前端部分的原因，其中，第一(及第二固定件)固定件4具有一个未被斜削的前端部4a’。在假体构件1从中间插入位置移动至最终锚固位置期间，未斜削的前端部4a’本身要插入骨内并在其前部形成压力，从而会导致后部皮层骨的分裂及在锚固的假体构件1后部中的预应力丧失。
在本发明的范围内可想到对上面参照附图描述的实施例可作出几种改进。例如，代替具有平滑连续的表面，固定件可如上文WO93/22990所示那样被刻有键槽或开有缝槽以增强其与骨组织的相互影响。为了增强稳定性，如WO93/22990所示，也可对接合件的接合面制出键槽。另外，如果需要可使用不止两个固定件，而在本发明的基本形式中仅使用了一个固定件。在不脱离本发明的情况下，也可省略设置在接合表面中的骨组织接收腔。另外，本领域技术人员应理解，在膝关节的股骨侧或另一个人或动物的关节处可使用本发明的假体构件。

Claims (15)

1.一种假体构件(1)，用于锚固于人体或动物体中关节的关节部分(11)的关节端上，该假体构件包括：一接合件(3)，该接合件具有一用于与设置在所述关节端上的互补关节端表面(14)相接合的平的或大致平的接合表面(3b)；以及一细长形固定件(4)，其被连接至接合面且与之间置，以便插入距所述关节端表面(14)一定距离处设置在所述关节端上的一互补孔(12)中，其特征在于：该细长形固定件(4)与接合表面(3b)形成一个锐角(β)。
2.根据权利要求1所述的假体构件，其特征在于：所述锐角(β)大于或等于1°。
3.根据权利要求1或2所述的假体构件，其特征在于：所述锐角(β)小于或等于5°。
4.根据权利要求1-3中任意一条所述的假体构件，其特征在于：所述锐角(β)在1°-3°的范围内。
5.根据前述权利要求中任一所述的假体构件，其特征在于：该细长形固定件为第一细长形固定件(4)且所述构件(1)包括一个或更多其它相应的细长形固定件(5)，所述固定件(5)大致平行于所述第一细长固定件(4)延伸，以用于插入距所述关节端表面(14)一定距离处设置在所述关节端的相应数目的其它互补孔(13)内。
6.根据前述权利要求中任一所述的假体构件，其特征在于：每一固定件(4，5)的一个插入端部分(4a)具有缩小的横剖面。
7.根据权利要求6所述的假体构件，其特征在于：每一插入端部(4a)均在朝向接合面(3b)的一侧被斜切，以便获得所述缩小的横剖面。
8.根据权利要求7所述的假体构件，其特征在于：斜切每一插入端部(4a)，其程度应使朝向接合表面(3b)的插入端部分的侧面与固定件(4，5)中保持部分(4b，4c)的相应侧边形成在1°-4°范围内的夹角(δ)。
9.根据权利要求8所述的假体构件，其特征在于：在每一插入端部分(4a)的斜切侧面和固定件(4，5)中保持部分(4b，4c)的相应侧边之间的夹角(δ)为大约2°。
10.根据前述权利要求中任一所述的假体构件，其特征在于：接合表面(3b)设有一个或多个骨组织接收腔(6a，6b，7a，7b)，它们在将假体构件锚固于关节端时，适于接收关节端表面的骨组织。
11.根据权利要求10所述的假体构件，其特征在于：每一骨组织接收腔(6a，6b，7a，7b)的形式为形成在接合表面(3b)上的纵向槽，所述纵向槽大致沿每一固定件(4，5)的方向延伸。
12.根据前述权利要求中任一所述的假体构件，其特征在于：每一细长的固定件(4，5)均以与相反对应侧在其中延伸的一般方向成一定倾斜角度地在接合件(3)的相反对应侧之间延伸。
13.根据前述权利要求中任一所述的假体构件，其特征在于：假体构件(1)为一关节假体组件(2)的锚固元件部分，用于使所述关节中关节部分(11)的关节端进行局部或整体移位。
14.根据前述权利要求中任一所述的假体构件，其特征在于：假体构件(1)适于锚固于人体或动物膝关节中一个关节部分(11)的膝关节端上。
15.一种大致参照相关附图所描述的适于锚固于人体或动物关节中一个关节部分的关节端的假体构件(1)。
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SE9804492D0 (sv) 1998-12-22
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KR20020015682A (ko) 2002-02-28
EP1139927B1 (en) 2005-02-02
ATE288237T1 (de) 2005-02-15
CA2356979A1 (en) 2000-06-29
WO2000036998A1 (en) 2000-06-29
DE69923589D1 (de) 2005-03-10
US7250061B2 (en) 2007-07-31
US20020022890A1 (en) 2002-02-21
AU2136900A (en) 2000-07-12
AU743145B2 (en) 2002-01-17
JP2002532191A (ja) 2002-10-02
US20040083005A1 (en) 2004-04-29

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