CN101466417A - 用于整形外科植入物的陶瓷金属复合材料 - Google Patents
用于整形外科植入物的陶瓷金属复合材料 Download PDFInfo
- Publication number
- CN101466417A CN101466417A CNA2007800213330A CN200780021333A CN101466417A CN 101466417 A CN101466417 A CN 101466417A CN A2007800213330 A CNA2007800213330 A CN A2007800213330A CN 200780021333 A CN200780021333 A CN 200780021333A CN 101466417 A CN101466417 A CN 101466417A
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- Prior art keywords
- ceramic
- implant component
- metal
- layer
- ceramic particles
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
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- 239000007943 implant Substances 0.000 title claims abstract description 87
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- 239000002344 surface layer Substances 0.000 claims description 22
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Images
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Abstract
本发明涉及由陶瓷金属复合材料制成的整形外科植入物。所述复合材料(28、48、54)包括生物相容性的金属或金属合金的一个相和包括碳化物、氮化物和/或氧化物的陶瓷粒子实例的第二相。在一些实施方案中，所述植入物包含作为多层组合物部分的均质的陶瓷层(24)。在一些实施方案中，所述多层组合物包含均质金属层(32)。
Description
相关申请的交互参考
[0001]本申请要求2006年4月11日提交的美国临时专利申请序列号60/790,918的优先权，其通过引用结合于本文，如同全文在本文周描述一样。
技术领域
[0002]本发明一般涉及用于整形外科植入物的陶瓷/金属复合材料，更具体的说，涉及用于髋关节植入物(hip implants)的此类材料。
发明背景
[0003]就髋关节植入物而言，“硬-对-硬”轴承的现行标准是陶瓷-对-陶瓷和金属-对-金属。固有地，陶瓷性质易碎，并且总是与折裂的有限的风险相关。可制备的陶瓷组件的大小也有局限性。大尺寸的陶瓷组件(尤其是衬垫)必须薄并且具有比较高的折裂风险。金属-对-金属组件仅具有可忽略的折裂风险并且可制备较大尺寸的组件。现行标准的金属-对-金属植入物的材料是高碳Co-Cr(钴-铬)合金。金属-对-金属植入物的主要问题是从关节溶出(release)金属离子并且其对人体生理学的未知的作用。金属-对-金属植入物的优点是，它们可以以较大尺寸应用。较大尺寸的植入物使得动作范围更大。金属-对-金属植入物也已经显示，对于在想要保存骨头时应用的表面重修(resurfacing)类型是有用的。在这样的较大的关节中，常规的聚乙烯或交联的聚乙烯不是优选的，因为逆轴承(counter-bearing)表面和金属-对-金属典型地是唯一的其它选择。这是由于较大尺寸要求聚乙烯衬垫更薄这样的事实。更薄的衬垫可具有较小的机械强度，可具有进行性的蠕变(creep)并可导致进行性磨损和骨质溶解，并且最终使植入物失败。
[0004]其它的常用的硬-对-硬植入物材料是陶瓷-对-陶瓷。陶瓷-对-陶瓷植入物的现行标准的材料是氧化铝。典型地，金属离子溶出不是这些植入物的问题。但是由于陶瓷有限的韧性和易碎的性质，难以用较大的尺寸制备这些植入物。陶瓷组件具有有限概率的折裂，因而导致与关节骨折相关的潜在的关节故障和并发症。
[0005]许多的在先技术的目的是通过金属和陶瓷组件的结合减少金属离子溶出和使折裂风险降至最低。在先技术之一是使金属离子溶出风险减少的途径是，采用使用扩散或等离子方法将合金表面上的氮和/或碳融合一体使硬体或衬垫或两者的表面变硬。另一个途径是用氮化物(氮化钛、氮化铬等)、氧化物(氧化铝、氧化锆、氧化锆-氧化铝等)的陶瓷涂层或钻石样碳或钻石涂层使金属表面涂上涂层。另一个途径是使用金属硬体对陶瓷衬垫或反之亦然。在该方法中，折裂风险与金属离子溶出一起减少。已经采用的另一个途径是，减少相关节的组件之间的直径方向间隙(diametrical clearance)，由此形成帮助减少磨损的厚的润滑膜。Fisher等(美国专利公布号2005/0033442)和Khandkar等(美国专利号6,881,229)讲授金属-与-陶瓷关节的应用。Fisher等讲授到，金属组件和陶瓷组件之间的硬度的差异应该至少为4000MPa。Khandkar等特别讲授氮化硅陶瓷组件作为倚着金属组件的关节的应用。在两个例子中，目的是降低相配的对子的磨损。但是，在在两个例子中，陶瓷的折裂风险仍然是很大的。
[0006]也见到陶瓷-金属复合材料应用于在先技术中。美国专利号6,620,523公开了由金属基质复合材料制备的滑冰刀片。滑冰刀片具有钛核和金属复合材料覆盖层。金属复合材料可包含钛或锆。美国专利申请公布号2004/0243241公开了整形外科装置，诸如由金属基质复合材料形成的脊椎植入物。金属基质复合材料包括生物相容性金属合金和加固组件，诸如硬的或难熔性(refractory)材料。
[0007]然而，本领域对于降低金属离子溶出的风险和整体陶瓷折裂的风险的改善的相关节的关节存在需求。本领域还对于其中一个或两个关节联接的表面包含金属基质复合材料的改善的关节联接的关节存在需求。
[0008]本发明一个特别的优点是降低整形外科植入物折裂和金属离子溶出的风险。该风险是通过使用梯度陶瓷金属复合材料组件与陶瓷表面和陶瓷表面下的梯度表面来降低的。如在本发明的详细描述中提到的，本发明的梯度(graded)陶瓷金属复合材料提供对以上描述的有关现行使用的“硬-对-硬”轴承的问题的解决方案。虽然本发明特别适用于髋关节植入物，其一般还适用于整形外科植入物。如本发明其它实施方案的实例，本文描述的组合物适用于膝关节和脊椎植入物以及其中需要硬-对-硬关节的其它植入物。
发明简述
[0009]本发明一般涉及适用于整形外科植入物的陶瓷/金属复合材料，更具体地说，涉及用于髋关节植入物的这样的材料。
[0010]在本发明的一个方面，整形外科植入物组件包含：包含金属物质(metallic species)和第二相的均质组合物，其中所述第二相包含陶瓷且其中陶瓷粒子之间的平均自由距离小于所述陶瓷粒子的平均大小；或者，多层组合物，其中一层或多层包含陶瓷、金属物质或陶瓷和金属物质的组合。
[0011]在一些实施方案中，陶瓷选自氧化铝、氧化锆、碳化铬、氮化铬、碳化硅、氮化硅、碳化钛、碳化锆、氮化锆、碳化钽、碳化钨及其任何组合。
[0012]在一些实施方案中，所述金属物质选自钴-铬、钛-铝-钒、锆-铌和钽及其任何组合的合金。
[0013]在一些实施方案中，其中所述多层组合物具有均质的陶瓷的表层，以及包含金属物质和包含陶瓷的第二相的表面下层，所述表面下层紧接于所述表层之下、并且与所述表层形成边界。
[0014]在一些实施方案中，均质的陶瓷表层厚度为约25μm。
[0015]在一些实施方案中，表层是100％氧化铝。
[0016]在一些实施方案中，表层由80％体积的氧化铝和20％体积的氧化锆组成。
[0017]在一些实施方案中，包含金属物质和包含陶瓷的第二相的表面下层是梯度层(graded layer)，其中陶瓷的水平从所述表层的边界的最初浓度向从所述表层的所述边界沿纵深进一步减少。
[0018]在一些实施方案中，植入物组件还包含紧接所述梯度层之下的均质的金属基底层。
[0019]在一些实施方案中，金属基底层是均质的钴-铬合金。
[0020]在一些实施方案中，在所述表面下层中的所述陶瓷的所述边界的浓度以体积计是98％。
[0021]在一些实施方案中，植入物组件包含多层组合物，其中一层包含陶瓷和金属物质的组合并且形成所述植入物组件的表面，并且其中所述一层是梯度层，其中陶瓷的水平从所述表层的最初浓度向从所述表面沿纵深进一步减少。
[0022]在一些实施方案中，植入物组件包含多层组合物，其中一层包含陶瓷和金属物质的组合并且形成所述植入物组件的表面，并且其中所述一层是梯度层，其中陶瓷的水平从所述表层的最初浓度向从所述表面沿纵深进一步减少，所述陶瓷的所述表面的浓度以体积计是98％。
[0023]在一些实施方案中，植入物组件包含含有金属物质和第二相的均质组合物，其中所述第二相包含陶瓷并且其中所述陶瓷包含氧化铝。
[0024]在一些实施方案中，陶瓷是氧化铝和氧化锆的混合物。
[0025]在一些实施方案中，植入物组件包含髋关节植入物。
[0026]在一些实施方案中，植入物组件包含膝关节植入物(kneeimplant)。
[0027]在一些实施方案中，植入物组件包含含有金属物质和第二相的均质组合物，其中所述第二相包含陶瓷，并且其中陶瓷粒子之间的平均自由距离小于所述陶瓷粒子平均大小的一半。
[0028]在一些实施方案中，植入物组件包含多层组合物，其中一层或多层包含陶瓷和金属物质的组合并且其中陶瓷粒子之间的平均自由距离小于所述陶瓷粒子的平均大小。
[0029]在一些实施方案中，植入物组件包含多层组合物，其中一层或多层包含陶瓷和金属物质的组合并且其中陶瓷粒子之间的平均自由距离小于所述陶瓷粒子平均大小的一半。
[0030]在本发明的另一个方面，制备具有梯度组合物的整形外科植入物组件的方法包括以下步骤：使陶瓷组分和金属组分的粉末混合至所需比例以形成第一混合物；使陶瓷组分和金属组分的粉末混合至所需比例以形成第二混合物；将所述第一混合物铺于所述第二混合物上，以产生第一分层混合物；任选混合粉末以形成一个或多个另外的混合物并将所述一个或多个另外的混合物铺于所述第一分层混合物上；以及，烧结所述第一分层混合物或烧结所述第一分层混合物和所述一个或多个另外的混合物的组合。
[0031]在一些实施方案中，至少一个混合步骤包括采用球磨工艺进行混合。
[0032]在一些实施方案中，至少一个混合步骤包括常规的高温烧结。
[0033]在一些实施方案中，至少一个混合步骤包括电场辅助烧结。
[0034]在一些实施方案中，至少一个混合步骤包括火花等离子体烧结。
[0035]在一些实施方案中，金属组件的杨格氏模量(Young’smodulus)的范围为约60GPa至约150GPa。
[0036]在一些实施方案中，所述方法还包括改变陶瓷/金属混合物中陶瓷粒子的大小和体积分数的步骤，以使陶瓷粒子之间的平均自由距离小于所述陶瓷粒子的大小。
[0037]在本方法的一些实施方案中，改变陶瓷/金属混合物中陶瓷粒子的大小和体积分数(这样陶瓷粒子之间的平均自由距离小于所述陶瓷粒子大小)的步骤，包括改变大小和体积分数，以使陶瓷粒子之间的平均自由距离小于所述陶瓷粒子大小的一半。
[0038]本发明的更多的特征、方面和优点，以及本发明的结构和多种实施方案的实施，在下面参考所附图详细描述。
[0039]之前已经相当广泛地概述了本发明的特征和技术优点，是为了可更好地理解以下对本发明的详述。本发明的另外的特征和优点将在形成本发明权利要求书的主题的下文中描述。本领域专业人员应该认识到，公开的概念和特别的实施方案可易于被利用，作为实现本发明同样目的的修饰或设计其它结构的基础。本领域专业人员还应该了解，这样的等价的构造不背离于所附权利要求书中所提出的本发明的精神和范围。相信是本发明的特点的新颖的特征，关于实施的组织和方法，两者均与更多的目标和优点一起，在下面考虑联系附图的描述时将更好地被理解。然而，应该清楚理解的是，每一幅图只是提供阐述和描述的目的，并不意味着说明对本发明的限制。
图的简述
[0040]为了更加理解本发明及其优点，现在参考联系附图进行以下描述，其中：
[0041]图1阐述为本发明的一个实施方案的髋关节假体；
[0042]图2显示本发明多层结构的实施方案的实例的横截面视图；
[0043]图3显示本发明多层结构的实施方案的实例的横截面视图；
[0044]图4显示具有包含金属物质和第二相(其中第二相包含陶瓷)的均质组合物的实施方案的实例的横截面视图；
发明详述
[0045]如本文所用的，“一”或“一个”意指一个或多个，除非另有所指。单数包括复数并且复数包括单数。因此，提及“陶瓷”或“陶瓷组件”时，此分别意指一种或多种陶瓷和一个或多个陶瓷组件。提及“金属”或“金属物质”时，此分别意指一种或多种金属和一种或多种金属物质。金属物质可为一种金属或金属合金。
[0046]如本文所用的，术语“均质陶瓷”包括，但不限于100％的一种特别的陶瓷(例如，100％氧化铝)。这样，术语“均质陶瓷”还包括陶瓷的混合物(例如，氧化锆和氧化铝以及可能的其它陶瓷的混合物)，只要基本上无非-陶瓷组分。类似地，术语“均质金属”或“均质的金属组件”包括，但不限于100％的一种特别的金属(例如，100％锆)。这样，术语“均质的金属”或“均质的金属组件”还包括金属的混合物(例如，锆和铪以及可能的其它金属的混合物)，只要不存在非-金属。
[0047]如本文所用的，术语“整形外科植入物组件”被定义为完整的整形外科植入物的一部分或完整的整形外科植入物。
[0048]其中组合物以百分率陈述，除非另有所指，所述百分率是体积百分率。
[0049]本发明涉及由陶瓷金属复合材料制成的整形外科植入物。该复合材料包括是生物相容性合金的第一相和是碳化物、氮化物、硼化物和/或氧化物的陶瓷粒子的第二相。陶瓷层可在金属中以体积计约1％至约100％(优选以体积计从约1％至约100％)存在于关节联接的表面。可将陶瓷相的体积分数从植入物的关节联接的表面至非关节联接的底层逐渐降低(graded)。可再通过允许氮、氧、碳或其组合扩散使所述复合材料变硬。可再将硬的碳化物、氮化物、氧化物涂层或钻石-样碳或多晶的-纳米晶钻石涂层或非晶型钻石涂层涂布在陶瓷复合材料上。
[0050]实现本发明的途径是使用陶瓷层是金属基质的部分的陶瓷金属复合材料。陶瓷层可以以从约1％至约100％体积存在于金属中。该层对金属提供硬化的表面，减少金属离子溶出，因为陶瓷粒子关节联接相互紧靠，代替了相互紧靠的关节联接的金属粒子，并且还降低与整体陶瓷相关的折裂风险。最初目的是减少金属-对-金属型关节联接中的金属离子溶出，但是变硬的表面也可用于与其它材料的关节联接处。
[0051]从下文提供的详细描述中，本发明适用性的更多领域将变得明了。应该明白，详细描述和特别的实施例，虽然是指本发明的优选的实施方案，但仅意欲为了阐述的目的，并不意欲限制本发明的范围。
[0052]以下对优选的实施方案的描述在性质上仅仅是作为例证，决不意欲限制本发明、其申请或应用。以下集中在髋关节植入物的大多数讨论是为了阐述的目的，但是应该明了，本发明也可适用于其它整形外科植入物。
[0053]图1阐述髋关节假体10。髋关节假体10包括股骨干12、股骨头14、衬垫16和外壳18。股骨头14有效地(operatively)连接股骨干12，和衬垫16装配至外壳18上。股骨干12适合于安装在大腿骨(未显示)中，而外壳18适合于安装在髋臼(未显示)。股骨头14相对衬垫16形成关节联接。
[0054]在本发明的一些实施方案中，股骨头14和/或衬垫16由陶瓷金属复合材料制成，其中的陶瓷层是金属基质的部分。在一个实施方案中，厚度为约5-200μm的100％陶瓷的表层下接着是具有最初为100％陶瓷并减少到纯金属或者到稳态水平的陶瓷的陶瓷/金属复合材料的梯度层。在另一个实施方案中，表面组合物可包含从约1％至几乎100％的陶瓷(表层具有少量的金属)。陶瓷层可以以体积计从约1％至约95％存在金属中。该层对金属提供硬化的表面，并且存在的相互紧靠的关节联接的陶瓷粒子减少金属离子溶出，也降低与整体陶瓷相关的折裂风险。在图1中描述的髋关节植入物10实施方案中，髋臼(acetabular)组件18的股骨头14和衬垫16两者均由陶瓷金属复合材料制成，但是本领域专业人员应该理解，在某些情况下只有一个组件由陶瓷金属复合材料制成。例如，股骨头14的陶瓷金属复合材料可相对聚乙烯衬垫、整体陶瓷衬垫或金属衬垫形成关节联接。或者，陶瓷金属复合材料衬垫16可相对聚合体的股骨头(诸如一个由聚乙烯制成的)、整体陶瓷股骨头或金属股骨头形成关节联接。如本领域专业人员应该理解的，术语“聚乙烯”包括常规的聚乙烯和交联的聚乙烯两者。还在图1的髋关节植入物10的实施方案中，于适当的上下文中阐述股骨干12的部分。尽管图1阐述本发明的髋关节植入物的应用，应该理解的是，此仅是一个阐述性的实例并且本发明可应用于所有整形外科植入物，诸如，但不限于膝关节植入物、肩部植入物、肘部植入物和其它植入物。
[0055]所述复合材料包括为生物相容性合金(钴铬基的、钛基的、锆基的、铌基的和/或钽基的)的第一相和为碳化物、氮化物、硼化物和氧化物，诸如但不限于碳化铬、碳化钛(TiC)、碳-氮化钛(TiCN)、碳化锆(ZrC)、碳化钽(TaC)、碳化铌(NbC)、碳化钨、氧化铝(Al2O3)和氧化锆(ZrO2)的陶瓷粒子的第二相。第二相可也包括多晶的、非晶型的和或纳米晶型的钻石砂砾。该复合材料可包括一种类型的陶瓷相或多于两种或更多种类型的陶瓷相的组合。
[0056]股骨头14和衬垫16的硬度可相同或各组件的硬度可不同。例如，陶瓷复合材料股骨头14可相对整体陶瓷衬垫16形成关节联接，其中复合材料中的陶瓷粒子的硬度与整体陶瓷的不同。作为另一个实例，陶瓷复合材料股骨头14可相对陶瓷复合材料衬垫16形成关节联接，股骨头中陶瓷粒子的硬度与衬垫的不同。陶瓷相的体积分数可从约1％至约100％变化，以使各组件具有不同的硬度。或者，可用这样的方式制备组件，即陶瓷相的体积分数从植入物的表面至底层是梯度的。例如，在表面可有大约100％的陶瓷相并且逐渐减小陶瓷相的体积分数至底层的核心小于约1％。梯度复合材料的目标不会显著影响基底材料的折裂韧性(fracture toughness)。
[0057]在本发明的一些实施方案中，可采用粉末冶金学方法实现此梯度结构。在这样的方法中，将陶瓷组分和金属组分的粉末混合和烧结。在需要均匀分散的陶瓷相时可采用球磨工艺达到混合。这样的方法为本领域普通专业技术人员已知。为了得到梯度结构，在形成各层中可应用粉末，然后将它们烧结在一起。采用常规的高温烧结方法或采用低温电场辅助烧结，可实现粉末的烧结。为本领域普通专业技术人员已知的这样的烧结方法以及其它烧结方法，在本发明中是有用的。烧结的温度将依赖于想要的合金组合物和结构类型。其它合金技术，诸如表面的电子束合金，也可被用来实现这样的梯度结构。在粉末冶金学方法的应用的一个非限制性实例中，制备氧化铝和CoCr复合材料结构。将CoCr粉末与氧化铝粉末以从25％至100％的体积分数进行混合。然后将这些混合物以不同层倾入石墨模具中。第一层是100％ CoCr。第二层是有25％氧化铝的CoCr。第三层是50％CoCr和50％氧化铝。第四层是75％氧化铝和25％ CoCr。顶(表面)层是100％氧化铝。然后采用火花等离子体烧结方法于1200℃下将该分层结构烧结。火花等离子体烧结是本领域已知的另一种烧结技术。该表面是100％的氧化铝和氧化铝的分数向底层减少。氧化铝粉末具有大的粒径范围，导致在基质中形成大的不连续粒(discontinuities)。本领域专业人员应该理解，粉末大小和分布状态还可再优化。在这样的复合材料结构中，期望100％氧化铝成为关节联接的表面。期望这样的表面消除金属离子溶出。该梯度组合物确保粘附至底层CoCr的氧化铝是适当足够的。在已描述的实例中，梯度组合物中的变化可为相对急剧的。本领域专业人员应该理解，该梯度组合物中的变化可为从逐级函数(更急剧的变化)至线性形式或者任何想要的其它形状的变化。本领域专业人员应该理解，采用常规的烧结方法，可实现这样的粉末混合物的烧结。在本发明的一个方面，也能够通过选择性地熔化表面，然后使其与陶瓷粒子形成合金，形成这样的结构。在另一方面，可在熔化的合金凝固期间使陶瓷粒子沉淀。在另一方面，可将陶瓷粒子分散于合金的熔化浴中，然后使混合物冷却以获得陶瓷粒子的均匀分布。
[0058]在一些实施方案中，采用低模量合金，诸如但不限于钛、锆或铌，形成陶瓷金属复合材料。这些合金的杨格氏模量典型地范围是从约60至约150GPa。较低模量的合金导致较低的接触压力并且允许形成较厚的流体润滑薄膜。该较厚的流体润滑薄膜减少关节联接的各组件的磨损。也选择低模量合金以帮助获得关节联接的组件间的较大的间隙(clearances)，其减少使关节抽搐(seizure)的机会。在本发明的一个方面，髋关节的相配组件间的直径方向间隙维持在大于150微米。
[0059]在一些实施方案中，以诸如陶瓷粒子间的平均自由距离小于陶瓷粒子平均大小的方式制备复合材料。此通过改变陶瓷粒子的平均直径(大小)和它们在金属中的体积分数实现。粒子的体积分数(Vp)，这些粒子间的平均自由距离(λ)，和以平均截距长度(L3)表示的粒子的平均大小，其相互关系可如下提供[金属手册(Metalls Handbook)第9版，第9卷，金相学和显微结构(Metallography and Microstructures)，ASM，1989)：
[0060]对于已知粒子大小(L3)和需要的粒子间距离(λ)而言，可选择适宜的粒子体积分数(Vp)作为起点。然后可再采用已知的和标准的技术分析评价该混合物，以检验以上表达的关系。在优选的实施方案中，平均自由距离(λ)小于平均截距长度(intercept length)(L3)至少10％。以上方法可反复重复以使粒子间平均距离最优化。可通过检测经过粒子质心的粒子的粒子直径，计算平均直径和将检测的直径求平均。对于非球形的粒子的情况而言，可经过粒子的周长上的不同位置的粒子质心检测直径。例如，对于椭圆体粒子而言，将在粒子的不同位置测定直径并可测定相同的粒子的平均值。可使用本领域专业技术人员熟悉的标准立体测量学(stereological)软件用于这样的目的。通常，粒子的大小范围可从亚微米尺寸(<1微米)至大到约200微米。基于粒子大小，可使用光学显微镜或扫描电子显微镜检测粒子大小。优选，在1000x下随机选择时可检查至少10-15个视野。如果采用高于1000x的放大倍率，可能需要检查更多的视野。本领域专业人员应该理解，通过检查更多数目的视野可提高这样的检测的正确度和精确度。可采用本领域普通专业人员已知的标准指南(诸如，例如，ASTM指南)用于本目的。通过控制陶瓷粒子间的平均自由距离，可降低较硬的陶瓷相对于较软底层的关节联接的风险。在这样的复合材料中，100％陶瓷不是总是必须的，尽管其在本发明的范围之内并且可能被使用。在整形外科植入物中相互紧靠进行关节联接的两种或更多种复合材料组件的每一个中，以下可独立控制：(1)陶瓷粒子的类型，(2)陶瓷粒子的体积分数，(3)陶瓷粒子的大小，(4)陶瓷粒子的粒度分布，(5)陶瓷粒子的形状和(6)金属基底层材料。具有独立控制粒度分布和体积分数的一种或多种类型的陶瓷粒子可用于复合材料中。
[0061]在一些实施方案中，以陶瓷粒子间的平均自由距离小于陶瓷粒子的大小的如此的方式加工复合材料。在一些实施方案中，陶瓷相间的平均自由距离小于陶瓷粒子的大小。此通过改变陶瓷粒子平均直径(大小)和它们在金属中的体积分数达成。可用经过粒子质心的粒子多数直径求平均计算平均直径。可使用本领域专业技术人员熟悉的标准立体测量学软件用于这样的目的。通常，粒子的大小范围可从亚微米尺寸(<1微米)至大到约200微米。通过控制陶瓷相间的平均自由距离，可降低较硬的陶瓷相对于较软底层的关节联接的风险。在这样的复合材料中，表面并不必须是100％陶瓷。在一些实施方案中，以陶瓷粒子间的平均自由距离小于陶瓷粒子的大小一半的如此的方式加工复合材料。
[0062]如果这样的复合材料的表面不是100％陶瓷，那么可通过采用等离子体或离子植入型方法使变硬层获得额外的优点，允许氮、氧、碳或其任何组合渗入(diffusion)，进一步使其变硬。通过允许渗入活性反应性物质，诸如硼、碳、氮和氧使变硬层获得在减少组件的磨损中的额外的优点，使复合材料进一步变硬。该渗入方法可伴随反应性物质的常规的高温渗入方法或伴随离子植入或伴随等离子体辅助方法。使这样的复合材料渗入变硬的深度范围可从约1微米至约1000微米。
[0063]在一些实施方案中，陶瓷复合材料上再涂布硬的涂层，所述硬的涂层为碳化物(TiC、ZrC、TaC等)或氮化物(TiN、ZrN、CrN等)或氧化物(Al2O3、ZrO2)或硼化物涂层或钻石样碳或多晶的/纳晶的钻石涂层，以减少金属离子溶出。可采用物理气相或化学气相沉积方法，涂布这些涂层。作为实例，经涂布的股骨头可相对于涂布的或未经涂布的衬垫形成关节联接。或者，经涂布的衬垫可相对于涂布的或未涂布的股骨头形成关节联接。
[0064]可规定股骨头14和/或衬垫16的表面粗糙程度，以使精巧的表面使在关节联接时呈现最大润滑。此外，可规定股骨头14和衬垫16之间的直径方向间隙，这样，精巧的表面使在关节联接时呈现最大润滑。
[0065]现在将描述这些示例性的和非限制性的本发明实施方案。应该理解的是，这些并不代表本发明的整个范畴。具有普通专业技术的本领域人员应该理解的修改，也是本发明的部分。此包括额外材料层的应用以及每层的不同的组合特征。
[0066]在第一个示例性的非限制性的本发明实施方案中，在图2中，有一个包含均质的陶瓷材料的表层24的整形外科植入物组件20(显示其中的横截面部分)。该表层24可为，例如，100％氧化铝。或者，表层24可为陶瓷，例如，以体积计80％氧化铝和20％氧化锆的混合物。然而，也可使用本领域普通专业技术人员已知的其它可能的均质陶瓷材料。一些实例包括氮化硅和碳化硅、碳化铬和碳化钛的混合物。一般来说，可制备多种这样的陶瓷粒子组合。该陶瓷表层24的厚度优选为约25μm，然而，可用到其它的厚度。陶瓷层的厚度将取决于陶瓷粒子间的相互的粘附以及粘附于界面的底层。该厚度应该这样，其将不使陶瓷层与表面分层。在均质的陶瓷层之下，存在包含金属和陶瓷的梯度结构28的陶瓷/金属混合物。在使用氧化铝作为其第二层的陶瓷材料的阐述性的实例中，该氧化铝应该具有最初浓度，该浓度随着从表面的深度加深而单调地下降。优选地，该最初浓度为95％至99％体积，但可为100％体积或低于95％体积的某个水平，并且然后单调地下降。该层之下，有均质的金属层32。在一个实例中，第二层28可具有以体积计95％陶瓷和5％金属的最初浓度(均质的陶瓷的第一层的正下方)并且在陶瓷内容物中下降至最终浓度为以体积计10％陶瓷和90％金属。然后开始可为100％体积的金属的第三层32。各单层的厚度范围可从5微米至500微米；陶瓷体积分数可以阶梯函数(急剧变化)下降或以线性形式下降。包含陶瓷/金属混合物的各层的特征可为，其陶瓷粒子之间的平均自由距离小于所述陶瓷粒子平均大小的一半。然而，陶瓷粒子之间的平均自由距离在多层组合物中不是必需的。
[0067]第二个示例性的、非限制性实施方案40示于图3。该实施方案不同于第一个实施方案，其中第二个梯度层48降低至陶瓷/金属的某个稳态的值。第二个梯度层48在均质的陶瓷组合物的表层24的下面。在优选的实施方案中，稳态水平主要是金属性的(例如，以体积计10％的陶瓷和90％的金属)。然而，其也可主要为陶瓷。在该实施方案中，没有不连续离散的第三层并且最终稳态的组合物形成材料的底层。因而，在图3中，我们看见具有均质的陶瓷层24和梯度陶瓷/金属层48的结构40。在层48内的某个深度，存在达到稳态的陶瓷和金属组合物，然后形成底层的剩余部分。包含陶瓷/金属混合物的该层的特征可为，其陶瓷粒子之间的平均自由距离小于所述陶瓷粒子平均大小的一半。然而，此陶瓷粒子之间的平均自由距离在多层组合物中不是必需的。
[0068]在示于图4的第三个示例性的非限制性实施方案中，组件50整个是均质的，单一层54包含陶瓷和金属的某种混合物。该混合物可为从1％至25％任何比例的陶瓷和从99％至75％任何比例的金属。优选地，该水平为1％至20％陶瓷和99％至80％金属。在此实施方案中，包含陶瓷/金属混合物的各层的特征可为，其陶瓷粒子之间的平均自由距离小于所述陶瓷粒子平均大小的一半。
[0069]虽然举例说明的实施方案阐述了陶瓷金属复合材料在用于髋关节植入物中的应用，但是陶瓷金属复合材料可同样在重建的膝关节组件并且特别是与聚乙烯或其它类型的聚合物形成关节联接的股骨的膝关节组件中得到实际应用。本文描述的本发明一般可适用于整形外科植入物，尽管优选的实施方案是髋关节植入物和膝关节植入物，它还可适用于，例如，本领域专业技术人员熟悉的肩、脊椎和其它整形外科植入物中。
[0070]如同参考相应的阐述所作的以上描述的那样，由于可对作为例证的实施方案进行各种修改，但不脱离本发明的范畴，所有包含在上文描述和显示于附图中的实质内容应该被解释为是示例性的而不是限制性的。因而，以上描述的作为例证的任何实施方案应该不限制本发明的广度和范围，并且本发明的广度和范围仅应该依照随后缩附的权利要求书和它们的等价物限定。
Claims (28)
1.一种整形外科植入物组件，其包含：
包含金属物质和第二相的均质组合物，其中所述第二相包含陶瓷，并且其中陶瓷粒子之间的平均自由距离小于所述陶瓷粒子的平均大小；或者，
多层组合物，其中一层或多层包含陶瓷、金属物质或陶瓷和金属物质的组合。
2.权利要求1的植入物组件，其中所述陶瓷选自氧化铝、氧化锆、碳化铬、氮化铬、碳化硅、氮化硅、碳化钛、碳化锆、氮化锆、碳化钽、碳化钨，及其任何组合。
3.权利要求1的植入物组件，其中所述金属物质选自钴-铬、钛-铝-钒、锆-铌和钽及其任何组合的合金。
4.权利要求1的植入物组件，其中所述多层组合物具有均质陶瓷的表层，以及包含金属物质和包含紧接所述表层之下的陶瓷的第二相的表面下层，并且与所述表层形成边界。
5.权利要求4的植入物组件，其中所述均质陶瓷的表层厚度为约25μm。
6.权利要求4的植入物组件，其中所述表层是100％氧化铝。
7.权利要求4的植入物组件，其中所述表层是80％体积的氧化铝和20％体积的氧化锆。
8.权利要求4的植入物组件，其中所述包含金属物质和包含陶瓷的第二相的表面下层是梯度层，其中陶瓷的水平从所述表层的边界的最初浓度向离所述表层的所述边界的深度加深而减少。
9.权利要求8的植入物组件，其还包含紧接所述梯度层之下的均质金属基底层。
10.权利要求9的植入物组件，其中所述金属基底层是均质的钴-铬合金。
11.权利要求4的植入物组件，其中于所述表面下层中的所述陶瓷的所述边界处的所述浓度以体积计是98％。
12.权利要求1的植入物组件，其包含多层组合物，其中一层包含陶瓷和金属物质的组合并形成所述植入物组件的表面，而其中所述一层是梯度层，其中陶瓷的水平从所述表面的最初浓度向从所述表面沿纵深进一步减少。
13.权利要求12的植入物组件，其中所述陶瓷的所述表面的所述浓度以体积计是98％。
14.权利要求1的植入物组件，其包含含有金属物质和第二相的均质组合物，其中所述第二相包含陶瓷和其中所述陶瓷包含氧化铝。
15.权利要求14的植入物组件，其中所述陶瓷是氧化铝和氧化锆的混合物。
16.权利要求1的植入物组件，其中所述植入物组件包含髋关节植入物。
17.权利要求1的植入物组件，其中所述植入物组件包含膝关节植入物。
18.权利要求1的植入物组件，其包含含有金属物质和第二相的均质组合物，其中所述第二相包含陶瓷，并且其中陶瓷粒子之间的平均自由距离小于所述陶瓷粒子的平均大小的一半。
19.权利要求1的植入物组件，其包含多层组合物，其中一层或多层包含陶瓷和金属物质的组合，且其中陶瓷粒子之间的平均自由距离小于所述陶瓷粒子的平均大小。
20.权利要求19的植入物组件，其包含多层组合物，其中一层或多层包含陶瓷和金属物质的组合，且其中陶瓷粒子之间的平均自由距离小于所述陶瓷粒子的平均大小的一半。
21.一种制备具有梯度组合物的整形外科植入物组件的方法，所述方法包括以下步骤：
使陶瓷组分和金属组分的粉末混合至所需比例以形成第一混合物；
使陶瓷组分和金属组分的粉末混合至所需比例以形成第二混合物；
将所述第一混合物铺于所述第二混合物上以产生第一分层混合物；
任选使粉末混合以形成一个或多个另外的混合物，并将所述一个或多个另外的混合物铺于所述第一分层混合物上；
和，
烧结所述第一分层混合物或烧结所述第一分层的混合物和所述一个或多个另外的混合物的组合。
22.权利要求21的方法，其中至少一个混合步骤包括采用球磨工艺混合。
23.权利要求21的方法，其中至少一个混合步骤包括常规的高温烧结。
24.权利要求21的方法，其中至少一个混合步骤包括电场辅助烧结。
25.权利要求21的方法，其中至少一个混合步骤包括火花等离子体烧结。
26.权利要求21的方法，其中所述金属组件的杨格氏模量的范围为约60GPa至约150GPa。
27.权利要求21的方法，其还包括改变陶瓷/金属混合物中陶瓷粒子的大小和体积分数的步骤，以使陶瓷粒子之间的平均自由距离小于所述陶瓷粒子的大小。
28.权利要求27的方法，其中所述改变陶瓷/金属混合物中陶瓷粒子的大小和体积分数，以使陶瓷粒子之间的平均自由距离小于所述陶瓷粒子大小的步骤，包括改变大小和体积分数，以使陶瓷粒子之间的平均自由距离小于所述陶瓷粒子大小的一半。
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| US60/790,918 | 2006-04-11 | ||
| PCT/US2007/066434 WO2007121242A2 (en) | 2006-04-11 | 2007-04-11 | Ceramic metal composite for orthopaedic implants |
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| CN101466417A true CN101466417A (zh) | 2009-06-24 |
| CN101466417B CN101466417B (zh) | 2014-02-05 |
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| EP (1) | EP2037976B1 (zh) |
| JP (2) | JP2009533181A (zh) |
| CN (1) | CN101466417B (zh) |
| AU (1) | AU2007238100B2 (zh) |
| CA (1) | CA2649108A1 (zh) |
| WO (1) | WO2007121242A2 (zh) |
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- 2007-04-11 US US12/296,315 patent/US8257835B2/en active Active
- 2007-04-11 WO PCT/US2007/066434 patent/WO2007121242A2/en active Application Filing
- 2007-04-11 CN CN200780021333.0A patent/CN101466417B/zh active Active
- 2007-04-11 JP JP2009505596A patent/JP2009533181A/ja active Pending
- 2007-04-11 AU AU2007238100A patent/AU2007238100B2/en active Active
- 2007-04-11 CA CA 2649108 patent/CA2649108A1/en not_active Abandoned
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101947149A (zh) * | 2010-10-08 | 2011-01-19 | 李亚东 | 多层壳芯复合结构件组成的人工髋关节 |
| CN102009175A (zh) * | 2010-10-08 | 2011-04-13 | 李亚东 | 一种多层壳芯复合结构零件的制备方法 |
| CN101947149B (zh) * | 2010-10-08 | 2013-01-02 | 李亚东 | 多层壳芯复合结构件组成的人工髋关节 |
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| CN108348339A (zh) * | 2015-07-02 | 2018-07-31 | 米如斯有限公司 | 用于医疗装置的钼合金 |
| CN106726012A (zh) * | 2016-11-25 | 2017-05-31 | 戴闽 | 一种全陶瓷人工髋关节假体及其制备方法 |
Also Published As
| Publication number | Publication date |
|---|---|
| US9107980B2 (en) | 2015-08-18 |
| AU2007238100A1 (en) | 2007-10-25 |
| WO2007121242A2 (en) | 2007-10-25 |
| CA2649108A1 (en) | 2007-10-25 |
| JP2013226444A (ja) | 2013-11-07 |
| EP2037976A2 (en) | 2009-03-25 |
| US20090187255A1 (en) | 2009-07-23 |
| WO2007121242A3 (en) | 2008-05-08 |
| JP2009533181A (ja) | 2009-09-17 |
| US20120306121A1 (en) | 2012-12-06 |
| US8257835B2 (en) | 2012-09-04 |
| EP2037976B1 (en) | 2019-11-20 |
| CN101466417B (zh) | 2014-02-05 |
| EP2037976A4 (en) | 2012-09-05 |
| AU2007238100B2 (en) | 2013-12-19 |
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