CN102630197B - 将聚合物构件与生物医学关节假体或形成其一部分的金属构件耦接的方法 - Google Patents

将聚合物构件与生物医学关节假体或形成其一部分的金属构件耦接的方法 Download PDF

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Publication number
CN102630197B
CN102630197B CN201080051236.8A CN201080051236A CN102630197B CN 102630197 B CN102630197 B CN 102630197B CN 201080051236 A CN201080051236 A CN 201080051236A CN 102630197 B CN102630197 B CN 102630197B
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polymeric member
hardware
polymer
described hardware
prosthesis
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CN102630197A (zh
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詹卢卡·扎皮尼
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Lincotek Trento SpA
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Eurocoating SpA
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Abstract

本申请描述一种用于将聚合物构件(44)与生物医学关节假体或形成其一部分的金属构件(40)耦接的方法。该方法包括以下步骤：提供所述聚合物构件；提供所述金属构件，其具有与待涂覆的所述聚合物构件的表面相同的几何形状/曲率的表面；使所述聚合物构件与所述金属构件接触；仅加热所述金属构件至等于或高于所述聚合物构件的熔融温度的工艺温度以在这两个构件之间的接触表面处实现所述聚合物构件的局部软化或熔融。

Description

将聚合物构件与生物医学关节假体或形成其一部分的金属构件耦接的方法
技术领域
本发明涉及将聚合物构件与形成生物医学关节假体的一部分的金属构件耦接的方法、以及由此获得的假体。
背景技术
在矫形外科领域，已研究了各种内用假体来替代不同骨骼构件或其部分(膝、髋、肩、手指、肘、脊柱等)，以使它们恢复其关节功能并尽可能反映其所替代部分的形态。
许多这样的内用假体由相互铰接的两个构件形成，每种这样的构件均具有铰接部分和锚固部分：铰接部分与相对的假体构件的相应铰接部分接触，而锚固部分与骨接触。
经常地，铰接部分之一由聚合物材料制得，并与第二假体构件的金属或陶瓷材料的铰接部分相对。
通常使用的聚合物材料是具有非常高的分子量的聚乙烯(UHMWPE：超高分子量聚乙烯)，其提供了非常低的摩擦系数和高耐磨性。最近，市场上已提出其他聚合物，如PEEK(聚醚醚酮)、碳纤维增强的PEEK、聚碳酸酯和聚氨酯。在任何情况下，UHMWPE仍然是使用最广泛的聚合物材料。
由于其低骨整合能力(osteointegrative capacity)和其低硬度，所以将聚乙烯UHMWPE与金属层(也称为“金属背衬”)耦接，使得假体构件的铰接部分和锚定部分由两种不同的材料构成。
例如，许多胫骨板，如图1中的那种，由与金属支持体12耦接的聚乙烯的铰接部分10构成，金属支持体12与骨14接触；髋臼杯，如图2中的那种，具有含有由聚乙烯制成的衬垫22的金属锚固壳20。
由这种类型的耦接所产生的一个问题是聚乙烯制的构件和金属支持体构件之间的微运动。由于未使用粘合剂，两种组装构件相互之间可能稍微移动并且可以在局部发生分离，导致可能出现假体不稳定的风险。另一个问题是聚合物衬垫和金属基体之间的磨损，其导致聚合物表面的磨耗，这是一个公知为“背侧磨损”的缺点，尤其在胫骨构件中。
为了避免这些缺点，理想的是能够直接用金属层覆盖聚乙烯元件，从而获得稳定的界面。
EP0761242描述一种通过热喷涂使用钛涂料涂覆聚合物构件的方法，但是该方法仅可能用于其中描述的熔点高的聚合物，如聚(芳酮)，而不适用于聚乙烯：在热喷涂过程中所达到的温度确实会使聚乙烯融化、变形，并降低其力学性能。
EP1082074描述了金属丝网与聚乙烯髋臼杯的耦接，然而，这无法保证假体构件的刚性，无论金属丝网多薄、多易变形，假体构件的刚性仍然低。
EP0726066描述了通过将三种构件或壳体连接而制造的髋臼杯假体：首先，通过将壳体插入模具中并注入聚合物、或者将壳体压入预热到熔融状态的聚合物预制件中，来将内壳与聚合物构件连接。
然而，在该专利申请中，聚合物部分仅构成预制件，该预制件必须被加工成最终形状，以能够插入第三金属外壳中。因此，尽管由于存在咬边而使得第一内壳与聚合物构件牢固地耦接，但是外壳并没有牢固地锚固。
因此，EP0726066中描述的方案并不能消除微运动的可能性和假体的不稳定性。
US4104339描述了一种在热塑性构件(人工晶状体，intraocular lens)中插入金属丝的方法，其通过将金属丝加热到稍高于热塑性塑料熔融温度的温度从而导致发生允许金属丝本身插入的局部熔融。
这一方法仅在所使用的聚合物材料在熔融状态下具有低粘度的情况下才提供令人满意的结果。
不同于人工晶状体，骨科构件基本上是由UHMWPE构成，其熔融状态下的粘度过高而不允许金属部件插入。
EP 1800700描述了通过激光烧结制造金属结构体的方法。这种结构体由多个多孔的表面层和非多孔的内部体构成，因此，具有至少3个不同孔隙度的层。通过将这种类型的金属构件与成形或腔体中的聚合物构件接触，或通过从外部施加热和压力，根据EP1800700，有可能使聚合物和金属相互渗透。聚合物可以是粉末形式，或是成品构件。如果能够获得成品构件，则该方法不考虑如下事实：通过将聚合物构件加热到其熔融温度以上的温度并通过施加外部压力，整个聚合物构件变形，由于热膨胀而产生内应力，并且聚合物本身热氧化的风险增加，尤其是当所使用的聚合物是特征在于高粘度的UHMWPE时，因此需要高压力以获得在金属构件中的相互渗透。
发明目的
本发明的目的是设计一种改进现有技术的方法。另一个目的是生产使用寿命更长、质量更好的医疗假体。
这些目的通过一种将聚合物构件与生物医学关节假体或形成其一部分的金属构件耦接的方法实现，该方法包括以下步骤：
提供所述聚合物构件，
提供所述金属构件，其具有与待涂覆的所述聚合物构件的表面相同的几何形状/曲率的表面，
使所述聚合物构件与所述金属构件接触，
仅加热所述金属构件至等于或高于所述聚合物构件的熔融温度的工艺温度，以在这两个构件之间的接触表面处实现所述聚合物构件的局部软化或熔融。
采用本发明的方法，能够将聚合物构件(例如聚乙烯)与金属构件耦接。相互的接触表面增加使得两种材料在界面处发生相互渗透，开发了聚合物在熔融状态的粘性/粘接性能和金属的导热性能。
仅加热所述金属构件，因为只有在界面区域发生熔融，所以避免整个聚合物构件的变形。
在根据本发明的方法的一个实施方案中，使所述聚合物构件与所述金属构件接触的步骤发生在加热所述金属构件的步骤之前。
适合该方法的聚合物构件为例如由UHMWPE或PEEK或碳纤维增强的PEEK、由聚碳酸酯或由聚氨酯制得的那些。
就金属构件而言，目前在骨科中使用的所有金属均适用于该目的，优选钛、钛合金、不锈钢、钴铬合金、钽、钽合金、铌、铌合金。
优选在加热步骤期间，进行使这两个构件相互倚靠挤压的步骤，以促进其沿接触表面的相互渗透。
应当指出，由于仅加热金属构件，所以可以施加压力，这提高了粘附力，并且避免了整个聚合物构件的变形。
金属构件可以是一定量的待烧结的粉末材料或成品构件。
为了促进聚合物和金属构件之间的匹配，金属构件可以是具有与待涂覆的聚合物构件的表面相同的几何形状/曲率的表面的物体。基本上，获得了形状耦接。
优选的是，为了提高界面的抗断强度，金属构件在具有相同的几何形状/曲率的所述表面处显示出粗糙性或多孔性或保持性元件(retentiveelement)或咬边以增加接触表面。关于增加接触表面的方法，参见例如PCT/IB2008/002261的内容。
在本发明的另一个实施方案中，为了促进聚合物构件和金属构件之间的匹配，金属构件可以具有与待涂覆的聚合物构件的表面相同的几何形状/曲率的表面。基本上，发生形状耦接。
在本发明的另一个实施方案中，聚合物构件和金属构件基本上具有相应的且相当的尺寸。
例如，在植入物的聚乙烯是即使在熔融状态下也具有非常高的粘度的UHMWPE时，可能并不存在最佳的结合。为了使粉末或金属构件相互渗透，因此需要有非常高的压力，该压力将使整个构件变形。
为了解决金属和聚合物构件之间的粘附力可能低的这一问题，在使它们相互接触的步骤之前，使用具有密封剂功能的、在熔融状态下流动性比聚合物构件大的聚合物的膜或粉末涂覆或覆盖聚合物构件和/或金属构件。在加热步骤中，金属构件随后被加热至等于或高于所述密封剂聚合物的熔融温度的工艺温度以在这两个构件之间的接触表面处实现所述密封剂聚合物的局部熔融或软化。
密封剂聚合物作为中间粘结层。由于其具有比聚合物构件大的流动性，所以其改善了聚合物和金属构件之间的接触和连接。此外，由于相对于聚合物构件，为了流动，其要求较小的压力，所以其避免了需要使用可能会改变聚合物构件尺寸的过高的压力。
尤其是，密封剂聚合物应基于初始构件的聚合物材料来选择：密封剂聚合物的熔融温度Ts应不高于Tp+50℃，其中Tp是形成初始构件的聚合物材料的熔融温度。非常优选的是，Ts应低于或等于Tp。
密封剂聚合物的膜或粉末优选选自聚烯烃、聚酯、聚砜、聚酮、聚酰亚胺、聚甲基丙烯酸酯、聚碳酸酯、聚氨酯或其共聚物。
在任何情况下，该方法还可以扩展到骨科中使用的其他聚合物材料。
尤其是，由于需要将UHMWPE制的构件与金属构件连接，密封剂聚合物的膜或粉末优选选自高密度聚乙烯(HDPE)、低密度聚乙烯(LDPE)、非常低密度聚乙烯(LLDPE)、线性聚乙烯(LPE)、高分子量聚乙烯(HMWPE)、超高分子量聚乙烯(UHMWPE)或这些聚合物的混合物。
本文所述的方法中的加热步骤可以例如通过在金属构件内诱导电流流通来进行：由于金属具有高导电性和导热性并由于聚合物具有低导电性和导热性，所以由焦耳效应而产生在金属构件内的热传导至金属/聚合物界面；通过辐射或通过接触，聚合物构件的表面也被加热，聚合物构件的其余部分保持在低得多的温度。挤压步骤中描述的压力可例如通过压力机施加至所述的两个构件，从而诱发这两个构件的相互渗透和/或密封剂聚合物的熔融和流体化。
能够诱导这些现象的任何装置、设备或设备组均适用于连接这两个构件。
作为优选的变化实施方案，通过SPS(放电等离子体烧结)来进行加热和挤压步骤，由于其便于能够整合加热和加压步骤。事实上，在SPS方法中，压力自然施加至模具，循环在模具本身和金属构件中的电流通过焦耳效应加热金属部件以及金属和聚合物构件之间的界面。SPS还具有提供快速(20至500℃/分钟)和在需要处(即，在金属-聚合物界面)精确加热的优点。
当最初的金属构件和密封剂聚合物均为粉末形式时，SPS方法还可以提供这样的优点：电流在金属粉末中通过，这在金属颗粒之间产生等离子体，该等离子体提高了相邻的密封剂聚合物颗粒的温度，导致它们熔融并促进金属颗粒的引入。当金属颗粒之间存在直接接触时，这种等离子体的产生，与外部压力相结合，可能导致这种金属颗粒的熔接，从而提高最终金属层的内聚力。
本发明还涉及根据上述方法获得的假体。
本发明的方法特别适合用于制造(但不仅为)髋臼杯、膝关节假体胫骨板、膝关节假体髌骨构件、肩盂假体构件、反向肩肱骨假体、假体椎间盘、假体肘关节的径向构件、腕关节或踝关节假体的构件、手和脚的指/趾假体关节，作为所得构件。
附图说明
由给出的本发明的方法的例子的说明，结合附图，本发明的其他特征和优点将变得更加清楚，这些附图中：
图1示出已知的膝关节假体的胫骨构件；
图2示出已知的髋关节假体的髋臼杯；
图3示出在根据本发明的方法中使用的可行的模具方案之一的剖视图。
图3示出一种模具，其由基体32和烧结机的导电材料(例如石墨)制成的冲头30通过SPS形成。在该模具中，UHMWPE制成的构件40、HDPE层42和金属构件44依次向上层叠。
层42比构件40在熔融状态下具有更大的流动性。
在该方法中，从外部施加轴向压力到基体32和冲头30上；采用公知的方法产生脉冲电流CR，并将其送至基体和冲头。箭头指出了电流的可能的方向。
电流CR通过焦耳效应以快速并均匀的方式仅加热构件44，构件44将热传导至层42，将其熔融。
层42除了热屏蔽构件44之外，比构件44的流体化程度也高得多并完全熔融。施加于模具的在冲头30和基体32之间的压力提高了构件40、44之间的层42的粘附力和均匀性。
简言之，获得了这样一种成品构件，其由相互完美熔接的三个元件40、42、44构成。

Claims (8)

1.一种将聚合物构件(44)与生物医学关节假体或形成其一部分的金属构件(40)耦接的方法，包括以下步骤：
提供所述聚合物构件，
提供所述金属构件，所述金属构件是在模具中的一定量的粉末材料，其设置为使得所述金属构件具有与待耦接的所述聚合物构件的表面相同的几何形状/曲率的表面，
使所述聚合物构件与所述金属构件接触，
然后，仅加热所述金属构件至等于或高于所述聚合物构件的熔融温度但是低于所述金属构件的熔融温度的工艺温度，以在这两个构件之间的接触表面处实现所述聚合物构件的局部软化或熔融、以及所述粉末材料在所述聚合物构件上的粘合。
2.根据权利要求1所述的方法，其中在所述加热步骤期间，进行使这两个构件相互倚靠挤压的步骤，以促进其沿接触表面的相互渗透。
3.一种将聚合物构件(44)与生物医学关节假体或形成其一部分的金属构件(40)耦接的方法，包括以下步骤：
提供所述聚合物构件，
提供具有密封剂功能的、在熔融状态下流动性比所述聚合物构件大的聚合物(42)的膜或粉末，
提供所述金属构件，所述金属构件是在模具中的一定量的粉末材料，其设置为使得所述金属构件具有与待涂覆的所述聚合物构件的表面相同的几何形状/曲率的表面，
使用具有密封剂功能的所述聚合物(42)的膜或粉末涂覆或覆盖所述聚合物构件和/或所述金属构件；
使得所述聚合物构件和所述金属构件接触，所述聚合物构件和所述金属构件中的之一或二者涂覆或覆盖有密封剂聚合物(42)的膜或粉末，
然后，仅加热所述金属构件至等于或高于所述密封剂聚合物的熔融温度但是低于所述金属构件的熔融温度的工艺温度，以在所述金属构件和所述聚合物构件之间的接触表面处获得所述密封剂聚合物的局部软化或熔融、以及由此的所述粉末材料到所述聚合物构件的粘合。
4.根据权利要求3所述的方法，其中所述密封剂聚合物的膜或粉末选自聚烯烃、聚酯、聚砜、聚酮、聚酰亚胺、聚甲基丙烯酸酯、聚碳酸酯、聚氨酯及其共聚物。
5.根据权利要求3所述的方法，其中所述密封剂聚合物的膜或粉末选自高密度聚乙烯(HDPE)、低密度聚乙烯(LDPE)、非常低密度聚乙烯(LLDPE)、线性聚乙烯(LPE)、高分子量聚乙烯(HMWPE)、超高分子量聚乙烯(UHMWPE)或这些聚合物的混合物。
6.根据权利要求3所述的方法，其中在所述加热步骤期间，进行使这两个构件相互倚靠挤压的步骤，以促进其沿接触表面的粘合。
7.根据权利要求1或3所述的方法，其中所述金属构件选自钛、钛合金、不锈钢、钴铬合金、钽、钽合金、铌、铌合金。
8.根据权利要求1或3所述的方法，其中所述方法得到的构件为髋臼杯、膝关节假体胫骨板、膝关节假体髌骨构件、肩盂假体构件、反向肩肱骨假体、假体椎间盘、假体肘关节的径向构件、腕关节或踝关节假体的构件、手和脚的指/趾假体关节。
CN201080051236.8A 2009-11-13 2010-11-12 将聚合物构件与生物医学关节假体或形成其一部分的金属构件耦接的方法 Expired - Fee Related CN102630197B (zh)

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