CN1741774A - 具有插入股骨内的柄轴的髋关节假体 - Google Patents

具有插入股骨内的柄轴的髋关节假体 Download PDF

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Publication number
CN1741774A
CN1741774A CN03825958.3A CN03825958A CN1741774A CN 1741774 A CN1741774 A CN 1741774A CN 03825958 A CN03825958 A CN 03825958A CN 1741774 A CN1741774 A CN 1741774A
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CN
China
Prior art keywords
rotor
bone
prosthese
hip prosthesis
arbor
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Granted
Application number
CN03825958.3A
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English (en)
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CN100571656C (zh
Inventor
H·D·林克
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Waldemar Link GmbH and Co KG
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Waldemar Link GmbH and Co KG
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    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
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    • A61F2310/00976—Coating or prosthesis-covering structure made of proteins or of polypeptides, e.g. of bone morphogenic proteins BMP or of transforming growth factors TGF

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Abstract

具有一个柄轴(12)的髋关节假体，该柄轴被插入到股骨内并包括凸出到骨骼转子区域(4)内的部分(13)。出于更密切连接骨骼的目的，该部分(13)具有一层包含骨诱导物质的覆层(16)。

Description

具有插入股骨内的柄轴的髋关节假体
股骨干骺端的骨松质具有骨小梁的复杂结构，通过它，在股骨颈、大转子、小转子和骨干处受到压缩载荷和拉伸载荷的骨骼部分以传递压缩和拉伸的方式被连接。他们总体上形成连续的拉伸和压缩轨迹(医学色谱，第7卷：运动器I.，Thieme出版社，斯图加特，1992)。当髋关节假体的柄轴被插入时，初级拉伸轨迹，特别是将股骨颈连接到相对的骨骼的粗隆间表面区域的大部分被打断。当他们因此不再参与载荷传递，他们会萎缩。该情况特别应用于使用假体时，其假体柄轴被夹持在骨干内且其中股骨的相邻的、干骺端区域，尤其在其侧部，几乎不能参与载荷传递。采用被称为拉伸杆柱的结构，已经进行了许多尝试以将假体柄轴连接到大转子区域，并通过这种方式使后者参与载荷的流动。连接到假体柄轴的杆被引导穿过大转子且杆的外部具有锁紧螺母，这样，在髋部假体载荷的作用下，拉伸被施加到大转子上(US-A-3,995,323，EP-B-93230，DE-B-1943598)。然而，已经发现这种力学拉伸杆柱很快由于恒定交替的载荷会变得松动，也因此只能有效一小段时间。还已知用这样的方式来设计该柄轴或从其侧向凸出到大转子区域内的翼：密切接触由骨质生长进入该翼的小孔或开口来获得(GB-A-1030145，FR-A-2356465，EP-A-A128036，EP-A-222236，EP-A-95440，EP-B-601223，EP-A-1044665)。为了促进骨骼与假体表面的连接，还已知可以使假体表面骨传导。该假体表面表示容许邻接骨骼生长的表面。它们包括由钛合金制成的表面以及包含磷酸钙或羟基磷灰石的覆层。
本发明的目的是提供一种假体，该假体在使用一个髋关节假体时使股骨干骺端的转子区域更强烈地参与载荷的流动。根据本发明的解决方案存在于权利要求的特征之中。
因此规定，至少部分假体的转子表面具有骨诱导的物质。与骨传导物质相反，骨诱导物质被理解为将无差别的多能的干细胞刺激转换为骨骼细胞的物质(Albrechtsson，Johansson：骨诱导、骨传导和骨整合，收录于：Gunzburg印刷(Hrsg)：骨质在脊骨外科中ob[原文如此]应用；springer.Denissen，H.等人：陶瓷羟基磷灰石植入用于二磷酸盐的释放；收录于：骨骼与矿物质1994，123-124页。Yoshinari，M.等人：磷酸钙覆盖和二磷酸盐固定的钛合金植入sto[原文如此]骨骼响应；收录于：生物材料2002，2879-2885页。Yoshinari，M.等人：表面修正的钛合金上二磷酸盐的固定；收录于：生物材料2002，709-715页)。这些物质包括二磷酸盐或BMPs(骨骼形态蛋白质)。在根据本发明的应用中这些是优选的。
对于该物质而言被混合在外部有意做成多孔的覆层内是特别有利的。覆层可以是任何想要的类型。例如，可以是一种多孔金属层。特别具有优势的覆层是这些覆层，其例如是天生骨传导的并且例如包括磷酸钙或羟基磷灰石。
本发明的效果在于，在手术之后，骨骼细胞立刻非常快速地生长接近和连接于假体表面。其结果是，不会由于骨骼表面和骨骼之间的相对运动最初就形成一个缝隙或一个中间连接薄层，该缝隙或中间连接薄层使接下来的密切连接受到不利影响或不可能。本发明正是基于这种认识，即使至今在假体表面和骨质之间看起来已经密切连接的情况下，实际上仍存在着间隔，即使只是存在微观的薄中间层。借助本发明的优点，会有更快的骨骼积聚发生在假体的转子的表面上，以及更快的骨骼生长到所述转子表面的小孔或凹槽内，这样使得转子的骨骼区域快速实现与假体的持久连接，并且作为这样设计的一个结果是骨骼区域参与载荷传递。
根据本发明的措施，通常只为假体的转子区域而提供。虽然本发明的范围不应排除骨诱导修正表面还应用于其他假体区域的可能性，这通常说来不期望如此，这是因为，由于所引起的密切接触，使得很难在后续的手术中将假体从骨骼上去除。
优选地，包含骨诱导物质的、转子假体部分的表面部分相对于侧向具有小孔或底切部分，这样由于骨诱导而形成的骨质不但可以附着于该表面并且可以通过形状连接锚固其上。
假体的转子表面被认为是在通常的植入之后意欲处于股骨转子区域内的表面。骨骼的转子部分是附图1中的阴影部分。开始于股骨颈部的中线和骨干近端中线之间的交点，转子区域侧向于从该交点到髋骨头部上边缘所绘出的切线，以及侧向于连接该切线的股骨颈部中线的一部分。假体的转子表面是其意欲位于骨骼转子部分的那部分表面。该表面部分可在其植入前容易地在假体上确定，因为人们知道它如何被植入以及因此它通常应当在骨骼内处于哪个位置。
在骨骼转子部分的中间，松质骨有时密度会比其靠近皮质的部分低。由于这种原因，假体的转子的、骨诱导表面部分的指向腹侧和背侧方向的部分最好间隔骨骼中位面一定距离。因此，形成这些表面部分的假体部分不应该在AP方向上太薄。优选地，其厚度以及从而在所述表面部分之间形成的距离超过6mm，更优选地超过9mm到大约15mm。
新鲜骨骼细胞在假体表面上的生长可通过所述表面部分的压配合得到促进。因此合适的是，所述表面以及它们的配合表面在假体被插入骨骼的方向内做成楔形，并且属于假体的且用于形成假体柄轴接收区域的锉刀(Raspel)具有稍小的横截面尺寸，这样，当假体柄轴被插入到由锉刀形成的空间内时，所述表面部分使骨质移位。
下面结合附图更详细地解释本发明，其中：
附图1显示了在包括柄的纵轴的平面内穿过股骨最近的部分的纵截面；
附图2显示了沿附图1中直线II-II的横截面；以及
附图3显示了沿附图1中直线III-III的假体截面。
骨骼外轮廓由实线显示在附图1中。骨密质1的内边界线也由实线表示，其厚度明显可见。这是骨干2区域内的情况。在干骺端3内，皮质在大部分部位很薄以至于只能以一条线表示。
干骺端3以及骨干上部的一些部位被骨松质(未示出)填充。在当前这种情况下只是对已知作为配属于大转子的转子区域4这一方面感兴趣，并且这已经由阴影显示出来。为了本发明的目的，它由边界线H和T界定。其中第一条线是股骨颈5和髋骨头6的中线。第二条线是经过线H和最近的骨干的中心轴线M的交点S的、位于绘图平面内的髋骨头6的切线。骨骼转子部分还包括位于绘图平面前后、处于阴影表面4的区域内的骨部分。
被插入骨骼内的假体由虚线表示于附图1中，并由实线表示在附图2和3中。它包括一个头部10、颈部11和柄轴12，凸出部13从中突出进入骨骼的转子区域4中。凸出部13具有孔14，这些孔形成面向腹部方向的表面区域。它们沿着侧向17底切。生长进入这些孔中的骨质在底切表面的后面抓紧，从而可以将拉伸载荷从假体传递到转子的骨骼区域。可以想到凸出部和底切表面还可用其他已知方式设计。例如，凸出部可以是片形或弓形的。代替孔，可以用更大的孔或肋条来形成底切表面。在正确的移植之后，通常情况下有意被置于转子区域4内的假体的这些部分被指定为转子部分或假体的转子表面。这些部分特别包括凸出部13。
假体类型被显示出来，其柄轴12以这种方式被设计和植入：使得其被坚固地锚固在骨骼的骨干2内。这种锚固的方式使得转子的骨区域上压力的极大地减轻。基于这种原因，本发明的应用对于这种假体类型特别具有优势。当然，它也可以应用在被锚固到干骺端的大范围上的和/或通过一个领子(Kragen)(未示出)支承在切除表面15上的其他假体类型。
柄轴12的表面或部分柄轴可以用公知的方式设计或安装以促使骨骼的连接。例如，可设有一个多孔的和/或包括磷酸钙或羟基磷灰石的覆层。这样的一个层还可以整体或部分地提供给假体的转子区域。例如，附图1中的交叉阴影线和附图2、3中的虚线表示具有覆层的区域16。根据本发明的该覆层包含一种骨诱导物质。
相应区域16内的骨诱导覆层引起在直接接触假体表面的区域还有任何底切的区域内强化的骨生长。因此，施加在假体上的力能够有效地从其表面传递到骨骼的转子区域4。由此，骨骼的转子区域也参与力流中，并防止骨骼断裂。
附图2描述了凸出部13在前后方向上具有巨大的厚度。其前面的和后面的表面部分16因此从中间区域被移除，中间区域中骨松质在一些情况下会被耗尽，且这些表面部位于一个靠近皮质的密集区域。骨骼表面和骨质之间良好连接的概率因此进一步提高。
附图3描述了凸出部13在近似相当于插入方向的III-III方向内的横截面形状。如果借助一个锉刀备好的、用于接收假体的空腔的形状稍小于假体形状，这种楔形往骨骼内的插入与骨皮质的移位以及因此与由骨质施加在假体表面的压力的增长相关。这也促使假体表面与骨骼之间迅速而密切的接触。
在描述的实施例中，只有凸出部13的覆层16具有一种骨诱导物质。从而，在假体表面和骨骼之间获得的密切接触在修正情况下会成问题的，因为所述假体部分不损害骨骼地从所述骨骼上去除是困难的。根据本发明这一特殊的特征，凸出部13因此被设计成可以从柄轴12上分离。例如，沿着附图1和2中用虚线表示的连接接头17借助螺纹件18或其他连接工具，凸出部13可被连接到柄轴12，并可在柄轴从骨骼上去除之前从后者上分离。凸出部因此可以更容易地从围绕它以及生长在它之上的骨骼上分离。

Claims (9)

1、具有一个柄轴(12)的髋关节假体，该柄轴被插入到股骨中且具有一个意欲位于转子区域(4)内的转子表面部分，其特征在于至少假体转子表面的一部分包括一种骨诱导物质。
2、根据权利要求1所述的髋关节假体，其特征在于，骨诱导物质由一层覆层形成或是部分覆层。
3、根据权利要求1或2所述的髋关节假体，其特征在于，骨诱导物质包括一种二磷酸盐或一种BPM。
4、根据权利要求1或2所述的髋关节假体，其特征在于，至少包含骨诱导物质的、转子的假体表面部分是多孔的。
5、根据权利要求1或2所述的髋关节假体，其特征在于，骨诱导物质被应用于沿侧向(17)底切的转子的假体表面的表面部分上。
6、根据权利要求1或2所述的髋关节假体，其特征在于，转子的假体表面包括一个腹面和一个背面，该腹面和背面具有一层骨诱导覆层(16)且彼此之间在AP方向上具有大于6mm，最好大于9mm的距离。
7、根据权利要求1至6中任一项所述的髋关节假体，其特征在于，转子的假体表面至少部分地通过一个从柄轴(12)突出的凸出部(13)而形成。
8、根据权利要求7所述的髋关节假体，其特征在于，凸出部(13)在植入方向上是楔形的，且一个配属于假体的锉刀在该凸出部区域内具有较小的体积。
9、根据权利要求8所述的髋关节假体，其特征在于，凸出部(13)可从柄轴上分离。
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ES2328808T3 (es) 2009-11-18
KR20050095647A (ko) 2005-09-29
JP2006513753A (ja) 2006-04-27
US20040158329A1 (en) 2004-08-12
CN100571656C (zh) 2009-12-23
BR0318096A (pt) 2005-12-20
WO2004069102A1 (de) 2004-08-19
CA2515065A1 (en) 2004-08-19
ATE435627T1 (de) 2009-07-15
KR101045407B1 (ko) 2011-06-30
AU2003232803B2 (en) 2010-02-25
US20050246033A1 (en) 2005-11-03
EP1592369A1 (de) 2005-11-09
DE50311696D1 (de) 2009-08-20
JP4347813B2 (ja) 2009-10-21
CA2515065C (en) 2011-07-12
EP1592369B1 (de) 2009-07-08
AU2003232803A1 (en) 2004-08-30

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