CN106604700B - 人工关节臼杯 - Google Patents

人工关节臼杯 Download PDF

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Publication number
CN106604700B
CN106604700B CN201580046451.1A CN201580046451A CN106604700B CN 106604700 B CN106604700 B CN 106604700B CN 201580046451 A CN201580046451 A CN 201580046451A CN 106604700 B CN106604700 B CN 106604700B
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CN
China
Prior art keywords
cup
cotyla
cotyla cup
ceramics
mortar
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Expired - Fee Related
Application number
CN201580046451.1A
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English (en)
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CN106604700A (zh
Inventor
A·乔希
A·迈耶霍夫
M·施密特
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Jossi Holding AG
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Jossi Holding AG
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Abstract

本发明涉及一种用于植入骨中的腔中的人工关节臼杯(2)且特别是髋关节臼杯。该关节臼杯(2)尤其基本呈具有凸形外表面(3)和凹形内表面(4)的球冠臼杯的形式。另外，该关节臼杯(2)包括外径(OD)和内径(ID)。所述外径(OD)和内径(ID)之差(D)同外径(OD)的比值在0.5到0.07之间、优选在0.3到0.075之间、更优选在0.2到0.1之间的范围内。本发明的特征在于所述关节臼杯(2)由陶瓷材料制成并且所述凸形外表面(3)具有宏观结构。

Description

人工关节臼杯
技术领域
本发明涉及根据权利要求1的前序部分的人工关节臼杯。
背景技术
当患者的关节窝例如髋臼出现损伤时，通常的做法是植入人工关节窝。这样的关节窝的各种设计是已知的。一方面，它们可以是分体式的，例如由外关节臼杯(外臼杯)和内关节臼杯(内臼杯)组成。外臼杯在这种情况下用于将关节窝嵌入骨中，而插入外臼杯中的内臼杯形成用于相应的关节头的支承面。另一方面，仅具有一个臼杯的一体式人工关节窝也是已知的。这两种类型的关节窝已经在临床实践中使用了很长一段时间。
如果例如由外臼杯和内臼杯组成的或仅有一个臼杯的关节窝作为预组装单元被植入，则它被称为所谓的整体式臼窝。这种关节窝降低了内臼杯从外臼杯中脱出的风险。它们非常稳定，但是它们的设计和各自材料的所需厚度造成它们相对较大。
结果，即使在对患者的自然关节窝例如髋臼损伤相当小的情况下，特别是当软骨损伤但骨完整无损时，在准备用于植入的骨时必须去除相当多的材料。特别是在年轻患者情况下，这意味着当准备骨以容纳人工关节窝时相当多的骨物质在早期已经损失，因此，对于后期可能需要进行的后续手术无法再提供如此多的骨物质以供使用。
常规的关节臼杯的另一个问题是，由于关节臼杯的所需壁厚，与自然关节相比，关节球比较小。由此，球窝关节特性被不利地改变。此外，由于关节球小，故非常高的负荷以点状出现在关节中。最后，人工关节臼杯的厚壁特别是在需要植入非常小的关节臼杯的患者的情况下是成问题的。
EP1025815A1公开了一种人工关节臼杯用于植入在患者的骨中的相应腔中，其壁厚为约2.5mm至3mm。所述关节臼杯由金属、特别是钴铬合金制成。此外，所述关节臼杯的内表面和外表面都可以涂覆有不同的材料。
然而，在这种关节臼杯中，小的壁厚造成在金属结构情况下只能困难地获得臼杯结构的所需的机械稳定性。此外，根据关节头材料的选择，关节头在金属臼杯的内表面上的滑动性能成问题，由此一来，关节臼杯的内表面有可能必须涂覆有另外的非金属材料。然而，只能相当费力地实现将特别光滑的涂层施加到关节臼杯的内表面上。另一个问题是将臼杯稳固嵌入患者的骨中。无法总确保稳定保持。此外，有时特别是在外表面上无法得到臼杯材料的生物相容性。
发明内容
因此，本发明的目的是克服现有技术的缺点。
特别是，本发明的目的是提供一种具有整体构型的且骨材料损失尽可能少地被装入髋骨中的关节臼杯。根据本发明的关节臼杯应该还允许使用具有与自然关节头基本相同的直径的关节头。该关节臼杯还应该能够以非常小的直径实现，并因此适于植入特别小的患者。关节臼杯应该还确保非常高的机械稳定性。此外，根据本发明的关节臼杯应该被患者良好地耐受，尤其应该具有高的生物相容性。但它尤其应该能够牢固锚定在骨结构中并且在短时间内与患者的骨建立稳固结合。
这些目的通过具有权利要求1的特征的关节臼杯来实现。
本发明涉及一种用于植入骨中的腔中的人工关节臼杯，特别是髋关节臼杯。特别是，关节臼杯基本上呈带有凸形外表面和凹形内表面的球冠臼杯形式。此外，关节臼杯具有外径(OD)和内径(ID)。在本文中，外径(OD)是指球的直径，该球的表面具有与根据本发明的关节臼杯的凸形外表面的平均曲率相同的曲率。内径(ID)是指其表面相当于本关节臼杯的凹形内表面的球的直径。外径(OD)和内径(ID)之差(D)同外径(OD)的比值在这里在0.5到0.07之间、优选在0.3到0.075之间、特别优选在0.2到0.1之间的范围内。
在4.0cm的臼杯外径(OD)情况下，它在相应的球冠臼杯情况下对应于在10mm到1.4mm之间、优选在6mm到1.5mm之间、更优选在4mm和2mm之间的范围内的壁厚。在9.0cm臼杯外径(OD)情况下，壁厚相应地在22.5mm和3.2mm之间、优选在13.5mm和3.4mm之间、更优选在9mm和4.5mm之间的范围内。
本发明的特征在于，关节臼杯由陶瓷材料制成并且凸形外表面具有宏观结构。
通过使用陶瓷作为臼杯材料，可以制造具有特别高的机械强度的非常薄的关节臼杯。因此，当将这种臼杯植入患者时，骨材料损失是最小的。此外，这种臼杯允许提供人工球窝关节，其关节头具有与在对应的自然关节中的关节头基本相同的的尺寸。由此获得尽量自然的关节特性。此外，避免了在较小关节球中经常发生的非常高的机械载荷。
此外，这种臼杯具有很高的身体耐受性，特别是优异的生物相容性。通过选择陶瓷作为臼杯材料，关节窝可以无任何问题地被植入患者骨中，在此，在短时间内出现臼杯外表面与骨结构的牢固结合。
在此，凸形外表面上的宏观结构起到重要作用。这种宏观结构显著增大关节臼杯的外表面。这额外促进了关节臼杯和其所植入的骨之间的牢固结合。
凹形内表面可以形成用于待容纳在关节臼杯中的关节球的支承面。通过这种整体式结构，所述臼杯不需要内臼杯(嵌体)，凹形支承表面也不必在生产过程中被涂覆。可以采用用于支承面和关节球的传统的材料组合，由此确保关节的最佳滑动性能。但或者，该凹形内表面也可以形成用于待容纳在关节臼杯中的内臼杯的保持表面。相应构造的关节窝可以仅作为外臼杯或以整体形式被植入。这种使用的多样性使得本发明关节臼杯可以应用在广泛的医学适应症中。
在关节臼杯的凸形外表面上的宏观结构可以包括多个结构元件。结构元件可以通过凹陷、优选通过材料蚀除部来限定并且具有0.3mm至3mm的尺寸。根据表面结构，可以实现这种关节臼杯的非常高效的制造，因为表面例如在生坯制造后可以被切削加工、研磨、蚀刻、喷砂、激光烧蚀或其它材料去除方法来加工。另一种可能性是在陶瓷关节臼杯的模制期间已经形成表面的宏观结构。对此例如考虑粉浆铸造作为可能的制造方法。将结构元件安排在更光滑的表面同样是可能的。
然而，所述宏观结构还可以包括具有尺寸为0.03mm至3mm的多个腔的多孔结构。这种多孔表面结构可以例如通过由多孔陶瓷材料制造关节臼杯或通过将多孔外陶瓷层施加到坯件上而获得。
这种宏观结构可适用于骨的小梁结构的向内生长。小梁结构，也称为骨松质，是在骨内部的细小的小梁的海绵状系统。这种骨结构长入关节臼杯表面的宏观结构中造成在关节臼杯和骨之间的很牢固的结合(骨整合)。
在根据本发明的关节臼杯的一个优选实施例中，将一行中的结构元件彼此分开的凹陷可被布置成相对于将相邻行中的结构元件彼此分开的凹陷彼此相对错移。通过这种布置，可以产生便于将植入物引入骨中的表面结构。此外，获得允许植入物在骨中良好锚定的表面结构。此外，作用在植入物上的力被最佳分散到周围骨组织。
界定结构元件的凹陷特别是材料蚀除部也可以通过具有相反斜率的交叉沟槽形成。这种表面结构还允许关节窝被良好锚定在骨中。此外，这种结构可以以非常简单和成本划算的方式被施用在关节窝表面上。
所述结构元件可以成形为立方体、角锥体、四面体、楔形体、多面体或具有锐角鞍形屋顶的形状。结构元件的形状取决于凹陷的形状，特别是取决于材料去除。因此，通过适当选择造型，可以提供大量的结构元件形状。通过这种方式，表面结构可以适配于相应类型的骨结构，由此根据存在的医学适应症可以实现植入物在骨中的理想锚定。
通过凹陷特别是材料蚀除部，可以形成凹形表面区域，其弯曲具有至少0.1mm的曲率半径。这在生产陶瓷关节臼杯的情况下在生坯表面在烧结之前被加工时是特别重要的。当半径小于0.1mm时，由于烧结期间的切口应力集中效应，断裂可能出现在植入物中。
制造关节臼杯的陶瓷材料可具有骨传导性能。与此相关，术语骨传导是指骨传导材料可以形成用于骨细胞的支持结构，由此促进自然骨生长。因此，由陶瓷制成的骨传导杯材料支持植入后的骨愈合过程并促进臼杯植入物和骨之间形成稳固结合。
制造关节臼杯的陶瓷材料可以由骨传导氧化物烧结陶瓷、优选是氧化锆陶瓷或氧化铝/氧化锆混合陶瓷组成。这种材料的特征在于优异的生物相容性、良好的机械加工性和高机械强度。
关节臼杯的凸形外表面优选具有骨传导涂层。由此可以只根据机械强度标准来选择陶瓷臼杯材料并且通过选择合适的涂层材料实现最佳的骨传导性。
骨传导涂层可以具有微观结构。这样的微观结构可以例如包括具有尺寸为0.003mm至0.3mm的多个腔的多孔结构。
由于所述的微观结构，骨传导涂层尤其还可以是骨整合的。与此相关，术语骨整合表面是指可以出现与有机化的活骨组织的直接的功能和结构结合的表面。由此可以实现植入物在为此所提供的骨中的最牢固的锚固。
骨传导性的且还优选是骨整合的涂层可以由骨传导金属、优选是骨传导过渡族金属组成。金属涂层特别适合用于陶瓷表面。作为可能的涂覆方法，为此考虑等离子体涂覆、气相沉积(化学气相沉积、物理气相沉积)、溅射、溶胶-凝胶沉积、沉淀或电泳。因此，骨传导涂层可以由铂或第二或第三过渡族元素、优选钛、锆、铌或钽组成。这种材料被广泛用于植入物的临床实践。
此外，骨传导性的且还优选骨整合的涂层可以由羟基磷灰石或骨传导氧化物烧结陶瓷、优选是氧化锆陶瓷或氧化铝/氧化锆混合陶瓷组成。陶瓷涂层非常适合于所述植入物，因为它们可以在植入物的生产期间被施加到生坯上，因此它们在烧结过程中与之材料融合。此外，这些材料的特征在于优异的生物相容性以及非常良好的骨传导性和骨整合性。
制造关节臼杯的陶瓷材料可由氧化物烧结陶瓷、优选氧化铝陶瓷、氧化锆陶瓷或氧化铝/氧化锆混合陶瓷构成。在生产过程中，这些材料可以被低成本且高效地加工、(特别是涂覆)。此外，它们允许高精度制造关节臼杯，该关节臼杯具有很高的机械强度。
此外，制造关节臼杯的陶瓷材料可以选自碳化钛陶瓷、碳氧化钛陶瓷、氮化钛陶瓷、碳氮化钛陶瓷、氮化铝钛陶瓷、碳氮化钛铝陶瓷、氮化钛锆陶瓷和氮化硅陶瓷。这些材料的特征在于非常坚硬，这给予关节臼杯非常高的刚性，此外在一体式关节臼杯情况下能够改善关节球在凹形支承面上的滑动性能。
附图说明
从下面对多个实施例的描述以及附图中得到本发明的其它优点和个别特征，其中：
图1示出了根据本发明的关节臼杯的俯视图；
图2示出了根据图1的关节臼杯的截面图；
图3示出了根据本发明的关节臼杯的替代实施例的截面图；
图4示出了根据本发明的具有螺旋沟槽的关节臼杯的俯视图；
图5示出了根据图4的关节臼杯的侧视图；
图6示出了根据本发明的关节臼杯的另一实施例的透视图；
图7示出了根据图6的关节臼杯的表面轮廓的细节图；
图8示出了根据本发明的具有反向螺旋沟槽的关节臼杯的另一实施例的俯视图；
图9示出了根据图8的关节臼杯的侧视图；
图10示出了根据本发明的具有涂层的关节臼杯的截面图；
图11示出了根据本发明的具有涂层的关节臼杯的替代实施例的截面图；
图12示出了根据图11的关节臼杯的截面图的一部分的放大细节。
具体实施方式
图1示出了根据本发明的具有关节臼杯的一体式关节窝1的俯视图。在这里，凹形支承面4同时还形成用于待插入关节窝1中的关节球的支承面6。
图2示出了根据图1的根据本发明的具有关节臼杯2的一体式关节窝1的截面。该关节臼杯呈具有凸形外表面3和凹形支承面4的球冠臼杯形式。关节臼杯具有外径(OD)和内径(ID)。
图3示出了根据本发明的具有关节臼杯2的分体式关节窝1的截面，内臼杯5被插入该关节臼杯中。该内臼杯5被刚性连接到关节臼杯2的凹形内表面4并且形成用于待插入关节窝1中的关节球的支承面11。
图4和图5示出了根据本发明的关节臼杯2的实施例的俯视图和侧视图。在这里，该臼杯的凸形外表面上的宏观结构包括多个结构元件7，这些结构元件由凹陷8界定，在这种情况下是由螺旋沟槽界定。
图6示出了根据本发明的关节窝2的替代实施例的透视图。所述关节窝2的表面轮廓在图7中被放大示出。可以看出，将一行的结构元件7彼此分开的凹陷9布置成相对于将相邻行的结构元件7彼此分开的凹陷10相对错移。
图8和图9示出了根据本发明的关节窝2的另一替代实施例的俯视图和侧视图。界定结构元件7的凹陷11在这里由具有相反斜率的多个交叉沟槽形成。
图10示出了根据本发明的具有光滑的凸形外表面3的关节窝2的截面局部。所示的关节臼杯2具有球冠臼杯形状。凸形外表面3具有骨传导涂层12。相反，凹形支承面4是未涂覆的。
图11示出了根据本发明的关节臼杯2的另一替代实施例的截面局部。在这种情况下，关节杯2具有宏观结构化的外表面3。该外表面3设置有骨传导涂层12。相反，在球冠臼杯的内表面上的凹形内表面4在这里也未涂覆。
图12示出了根据图11的根据本发明的关节臼杯2的截面局部的放大细节。可以看出，又具有孔13的骨传导涂层12位于宏观结构的结构元件7上。通过这些孔，表面可以允许与骨组织形成直接的功能和结构结合。

Claims (20)

1.一种用于植入骨中的腔中的人工关节臼杯(2)，其呈带有凸形外表面(3)和凹形内表面(4)的球冠臼杯形式，具有外径(OD)和内径(ID)，所述关节臼杯(2)由陶瓷材料制成，并且所述凸形外表面(3)具有宏观结构，其特征在于，所述外径(OD)和内径(ID)之差(D)同外径(OD)的比值在0.2到0.1之间的范围内，并且制造所述关节臼杯(2)的陶瓷材料选自碳化钛陶瓷、碳氧化钛陶瓷、氮化钛陶瓷、碳氮化钛陶瓷、氮化铝钛陶瓷、碳氮化钛铝陶瓷、氮化钛锆陶瓷和氮化硅陶瓷。
2.根据权利要求1所述的关节臼杯(2)，其特征在于，所述凹形内表面(4)形成用于待容纳在所述关节臼杯(2)中的关节球的支承面(6)。
3.根据权利要求1所述的关节臼杯(2)，其特征在于，所述凹形内表面(4)形成用于待容纳在所述关节臼杯(2)中的内臼杯(5)的保持表面。
4.根据权利要求1所述的关节臼杯(2)，其特征在于，所述宏观结构包括通过凹陷(8)来界定的并具有0.3mm至3mm的尺寸的多个结构元件(7)。
5.根据权利要求1所述的关节臼杯(2)，其特征在于，所述宏观结构包括具有尺寸为0.03mm至3mm的多个腔的多孔结构。
6.根据权利要求1所述的关节臼杯(2)，其特征在于，所述宏观结构适于骨的小梁结构的向内生长。
7.根据权利要求4所述的关节臼杯(2)，其特征在于，将一行中的结构元件(7)彼此分开的凹陷(9)布置成相对于将相邻行中的结构元件彼此分开的凹陷(10)相对错移。
8.根据权利要求4所述的关节臼杯(2)，其特征在于，界定所述结构元件的凹陷(11)由具有相反斜率的多个交叉沟槽形成。
9.根据权利要求4所述的关节臼杯(2)，其特征在于，所述结构元件(7)成形为多面体或具有锐角鞍形屋顶的形状。
10.根据权利要求4或权利要求7至9中任一项所述的关节臼杯(2)，其特征在于，所述凹陷(8,9,10,11)形成凹形表面区域，其弯曲具有至少0.1mm的曲率半径。
11.根据权利要求1所述的关节臼杯(2)，其特征在于，制造所述关节臼杯(2)的所述陶瓷材料具有骨传导性能。
12.根据权利要求11所述的关节臼杯(2)，其特征在于，制造关节臼杯(2)的陶瓷材料由骨传导氧化物烧结陶瓷构成。
13.根据权利要求1所述的关节臼杯(2)，其特征在于，所述凸形外表面(3)具有骨传导涂层(12)。
14.根据权利要求13所述的关节臼杯(2)，其特征在于，所述骨传导涂层(12)具有微观结构。
15.根据权利要求14所述的关节臼杯(2)，其特征在于，所述微观结构包括具有尺寸为0.003mm至0.3mm的多个腔(13)的多孔结构。
16.根据权利要求13至15中任一项所述的关节臼杯(2)，其特征在于，所述骨传导涂层(12)还是骨整合的。
17.根据权利要求13所述的关节臼杯(2)，其特征在于，骨传导性的涂层(12)由骨传导金属构成。
18.根据权利要求17所述的关节臼杯(2)，其特征在于，骨传导性的涂层(12)由铂或第二或第三过渡族元素构成。
19.根据权利要求13所述的关节臼杯(2)，其特征在于，骨传导性的涂层(12)由羟基磷灰石或骨传导氧化物烧结陶瓷构成。
20.根据权利要求13所述的关节臼杯(2)，其特征在于，制造所述关节臼杯(2)的陶瓷材料由氧化物烧结陶瓷构成。
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