CN100528104C - 包括插入股骨的轴的髋关节假肢 - Google Patents

包括插入股骨的轴的髋关节假肢 Download PDF

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Publication number
CN100528104C
CN100528104C CNB2005800266502A CN200580026650A CN100528104C CN 100528104 C CN100528104 C CN 100528104C CN B2005800266502 A CNB2005800266502 A CN B2005800266502A CN 200580026650 A CN200580026650 A CN 200580026650A CN 100528104 C CN100528104 C CN 100528104C
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Prior art keywords
bone
artificial limb
hip joint
axle
joint artificial
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CN1993091A (zh
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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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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
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Abstract

本发明涉及一种包括可以插入股骨中的轴(3)的髋关节假肢，所述假肢的表面具有骨诱导物质。所述物质仅在轴(3)的干骺端部分(5)中并且在相对于该轴横截面最大AP尺寸的线(7)的旁边上。因此该干骺端假肢更加有效地结合在力的分布中，而不会不利地影响假肢的再次手术能力。

Description

包括插入股骨的轴的髋关节假肢
股骨干骺端中的松质骨组织包括复杂的骨小梁结构，该结构在股骨颈较大的转节、较小的转节和骨干上传递压载荷和拉伸载荷地连接受压和拉载荷的骨的部分。在总体上，它们形成了连续的压和拉伸轨迹(Farbatlanten der Medizin[Colour Atlas of Medicine]，第7卷：Bewegungs apparatus I.，Verlag Thieme，Stuttgart，1992)。当插入髋关节假肢的轴时，特别地，将股骨颈连接到骨头的相对的转节间表面区域上的主要拉伸轨迹大部分被中断了。随后当它们不再参与力的传递时，它们就会退化。这特别是对于以下假肢，该假肢轴被夹持在骨干中，并且其中股骨的近端的干骺端区域，特别是在侧向部分很少进行力传递。曾尝试使用所谓的拉伸锚，将假肢轴连接到较大转节的区域上，这样将其包含在力流中。连接到假肢轴上的连杆被引导通过较大的转节并且在外侧有锁紧螺母，因此一旦加载了髋部假肢，就在较大的转节上施加拉伸力(US-A-3,995,323，EP-B-93230，DE-B-1943598)。然而已经发现，由于恒定的交替负载，这类型的机械拉伸锚会快速地松开，因此只在很短时间内有效。还已知构造使该轴或者从其侧向突入到较大转节的区域中的翼，从而紧密连接长入到该翼片的孔或开口中的骨物质(GB-A-1030145，FR-A-2356465，EP-A-128036，EP-A-222236，EP-A-95440，EP-B-601223，EP-A-1044665，US-A-5755811，US-A-4718915，US-A-5370698，FR-C-2194123)。为了促进骨头和假肢表面的连接，还已知要使得假肢表面设计成骨诱导。该术语表示该表面可以允许相邻骨头生长。它们包括由钛合金和包括磷酸钙或羟磷灰石的覆盖层所制成的表面(EP-A-761182，WO9308771)。
最近，已经知道了不仅可允许与骨诱导表面相似的骨头成长，还可刺激无差别多能干细胞用于形成骨细胞的物质(Albrechtsson，Johansson：Osteoinduction，Osteoconduction andOsseointegration，Gunzburg Hrsg：The use of bone substitutes inspine surgery中；Springer.Denissen，H.et al.：Ceramic hydroxyapatiteimplants for release of bisphosphonate，Bone and Mineral 1994中，第123-134页，Yoshinari，M.et al.：Bone response to calciumphosphate-coated and bisphosphonate-immobilized titanmium implants，Biomaterials 2002中，第2879-2885页，Yoshinari，M.et al.：Immobilization of bisphosphonates on surface-modified titanium，Biomaterials 2001中，第709-715页)。这些物质包括双磷酸盐(bisphosphonate)和骨形成蛋白质(bone morphogenic proteins)(BMP)。这些也可以用于完成骨头假肢，包括髋部假肢的表面(US-A-2002/0049497，US-A-2002/0127261)。它们使得假肢表面与骨头非常紧密地连接，而这在随后的外科手术中是不理想的，因为它会妨碍要从骨头上取出的假肢的松开。
本发明的目的是改进股骨髋部假肢在骨头中的固定，并且不会损害随后进行手术的能力。根据本发明的解决方法特征在于权利要求中的特征。
因此，对于具有插入股骨中的轴的髋关节假肢，仅在轴的干骺端部分中位于最大AP尺寸的线横旁边的部分设置了骨诱导覆盖层。
在此前的不属于出版现有技术的专利申请中(PCT/EP03/05292)，提出仅在转节区域中提供骨诱导物质，如以下所限定。从股骨颈中心线和近骨干端中心线之间交叉点开始，则转节区域位于从该交叉点到髋骨头部的顶部边缘的切线的旁边及在股骨颈中心线的延续该切线的部分的旁边。
根据本发明，不同地限定出要设有骨诱导物质的表面区域的边界。根据本发明的限定是使在干骺端部段的有许多法向包含侧向分量的表面区域的部分中设置假肢骨诱导表面。此前的经验表明，在这些表面区域中，并不期望与骨头的传递拉伸力的连接。然而由于骨诱导覆盖层，可能最大的部分地有这样的连接。此前申请的权利要求5提出在相对于横向方向为下切，即向着中间的方向看的表面区域上，布置覆盖层。
特别有利的是，将该物质设到理想地为多孔的覆盖层中。该覆盖层可以为任何想要的类型。例如，它可以是多孔金属层。特别有利的覆盖层原本就为骨诱导的，例如包括磷酸钙或者羟磷灰石。
本发明的效果在于，在手术之后在假肢的附近快速产生并快速与假肢表面连接。这样的结果是，骨头表面和骨头之间不会由于相对运动最初造成间隙或者连接组织中间层，其使得后来的紧密连接受不利影响或不可能。根据本发明，可以更快速地在假肢的转节表面上累积骨头以及更快速地将骨头结合在其孔或凹陷之内，因此骨头的转节区域快速地持久连接到假肢上，并且由此，参与力的传递。相反的，在其它表面区域上，只以当前已知的程度连接到骨头上。在转节的易于被随后的外科手术所触及的以及即使在骨头非常牢固结合时也不会产生任何问题的区域之外，在再手术的时候，医师会发现正是他非常习惯的情况。
表面的包括骨诱导物质的部分有利地包括孔或者关于横向的下切，因此由于骨诱导而形成骨质不仅可以通过附在表面上，还可以用形状配合连接而锚固在其上。
在骨头转节的部分的中间，该松质物质有时密度低于附近的皮层。由于该原因，假肢的骨诱导表面区域的指向腹侧和背侧方向的这些部分，优选地与骨头的中间面隔开一定的距离并且更靠近皮层。因此，假肢的形成这些表面的部分在AP方向上不应当太薄。其厚度，以及所述背侧和腹侧表面区域之间的距离，优选为超过6mm，更有利地是超过9mm到大约15mm。
可以通过所述的表面区域的压配合而促进新鲜骨细胞到假肢表面上的成长。因此有利的是，如果所述的表面和它们的配合表面，在假肢插入骨头的方向上被制成楔形形状，并且如果分配给假肢并且形成用于在假肢轴的接收空间的粗锉刀具有较小的横截面尺寸，从而当假肢轴被推入由粗锉刀形成的空间中时，所述的表面区域挤压骨质。
下面将参考附图更详细地叙述本发明，其中：
图1示出了股骨髋关节假肢的腹侧图，
图2示出了沿着图1中II-II线的横截面，
图3和4示出了可选的横截面形状，
图5示出了沿着图1中V-V线的横截面。
根据图1的髋部假肢包括关节头1，以及具有轴3的颈2。其具有要锚固在骨干中的骨干部段4，以及要锚固在骨头干骺端中的干骺端部分5。骨干部段的尺寸使其锚固在股骨的骨干中。熟悉本领域的人员从图1可以看出，假肢是如何位于骨头中，而且将会知道骨干部段和干骺端部段之间的界线8位于何处。
轴的骨干部段4可以支承在骨干的强壮的皮层骨上并且在那里的实现锚固，而干骺端部段主要位于干骺端的松质骨组织中。
图2示出了轴3在AP方向上(前后(antero-posterior))具有最大尺寸的位置7。在图2中用线7示出了最大AP尺寸的位置的连接。它在假肢的整个长度上延伸。对于本发明，只关注其在干骺端部段5中的延伸。在该线的侧面，图3中所示实施例中的轴表面仅由表面区域构成，其中该表面的法线具有在侧向方向指向的分量。这表示通过常规的方式不可能在这些表面和骨头之间获得可以承受中间方向假肢力的连接。这些力事实上以这些表面区域和骨头之间的拉伸连接为前提。在根据图4或图5的所示实施例中，在位置或线7的旁边上还具有下切表面区域，在下切表面区域中该表面的法线没有在侧向方向上指向的分量。然而，向侧向的表面部分在这里还是最主要的。
根据本发明，轴表面位于干骺端部段中的(就是说在线8以上的部分)并且在线7横向方向的部分6有骨诱导物质。其在图中用点表示。装置优选地包括一层骨诱导材料，例如羟磷灰石。通过该装置，可以强化相应的表面区域和骨组织之间的连接，使得它可以传递拉伸力。就是说松质骨组织中的拉伸轨迹部分参与力的承受，因此不会被破坏。
在图1所示的实施例中，根据本发明设置的区域包括位于干骺端的转节区域中的突起9。该转节突起为通常用于改善骨组织中轴的锚固，并且用于防止该轴相对于骨头转动。
也可以在轴3的其它区域中提供促进连接到骨头上的表面构造，即线7的中间和远离线8，例如带有羟磷灰石或者磷酸钙的覆盖层。然而，它那里应当不包括骨诱导成份，因为否则在随后的外科手术中从骨头中取出假肢轴会很困难。
图2示出突起13在前后方向上具有相当大的厚度。因此其前和后表面区域6不在在一些情况下松质骨质会耗尽的中心区域，而在更靠近皮层骨的更致密的区域。因此，进一步加强了在骨头表面和骨质之间形成良好连接的可能性。
图5示出了突起9在大致对应于插入方向的截面方向V-V上的横截面形状。如果通过粗锉刀准备的为了接受假肢的空腔略微小于假肢的形状，将该楔形形状插入骨头会使得挤压骨质，并且由此使得由骨质施加到假肢表面上的压力增加。这样还会促进假肢表面和骨头的快速成长的以及紧密的接合。
为了确保转节突起的表面和骨头之间的紧密连接不会妨碍随后的处理，突起9可以从轴3上卸下。例如，它可以通过螺钉或者其它连接装置连接到轴3上，并且可以在将轴从骨头上移走之前从所述轴3上卸下。该突起随后可以易于从围绕着它的并与之生长的骨头取出。
根据本发明设置的表面不限于图1和2所示的假肢形状。在图3和4中示出了其它横截面形状的示例。其中附图标记7在此表示在AP方向上最大厚度的横截面位置，本发明可以在其旁设置骨诱导的假肢表面。

Claims (9)

1.髋关节假肢，带有要插入股骨的轴(3)，其表面有骨诱导的设置，其特征在于，该骨诱导的设置仅设在轴(3)的在干骺端部段(5)中的位于该轴横截面最大AP尺寸的线(7)旁边的部分(6)中。
2.根据权利要求1所述的髋关节假肢，其特征在于，该骨诱导物质由覆盖层形成或者包括在覆盖层中。
3.根据权利要求1或2所述的髋关节假肢，其特征在于，骨诱导物质包括双磷酸盐或者骨形成蛋白质。
4.根据权利要求1或2所述的髋关节假肢，其特征在于，至少假肢表面的包括骨诱导物质的部分(6)为多孔的。
5.根据权利要求1或2所述的髋关节假肢，其特征在于，设置骨诱导物质的假肢的部分(6)包括至少两个腹侧或背侧相对表面，其在AP方向上的距离大于6mm。
6.根据权利要求1或2所述的髋关节假肢，其特征在于，设置骨诱导物质的假肢的部分(6)至少部分地由从该轴(3)延伸出的突起(13)形成。
7.根据权利要求6所述的髋关节假肢，其特征在于突起(13)可以从该轴上卸下。
8.由根据权利要求6或7所述的髋关节假肢以及用于在髋关节假肢轴上形成接收空间的粗锉刀构成的套件，其特征在于突起(13)在植入方向上为楔形形状，并且粗锉刀在该突起的区域中具有较小的体积。
9.根据权利要求5所述的髋关节假肢，其特征在于，所述距离大于9mm。
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AU2005270361A2 (en) 2006-02-16
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CA2575568A1 (en) 2006-02-16
US20110190900A1 (en) 2011-08-04
CA2575568C (en) 2012-05-15
US20080033568A1 (en) 2008-02-07
BRPI0513069B8 (pt) 2021-06-22
AU2005270361A1 (en) 2006-02-16
EP1776068B1 (de) 2010-01-20
JP2008508914A (ja) 2008-03-27
TW200607482A (en) 2006-03-01
ES2338440T3 (es) 2010-05-07
WO2006015812A1 (de) 2006-02-16
ATE455517T1 (de) 2010-02-15
CN1993091A (zh) 2007-07-04
AR054675A1 (es) 2007-07-11
US7947084B2 (en) 2011-05-24
EP1623685A1 (de) 2006-02-08
TWI377053B (en) 2012-11-21
BRPI0513069B1 (pt) 2020-06-23
AU2005270361B2 (en) 2010-08-26
KR101186437B1 (ko) 2012-09-27
JP4564533B2 (ja) 2010-10-20
KR20070056085A (ko) 2007-05-31
BRPI0513069A (pt) 2008-04-22

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