CN1226053C - 用氧化锆－氧化铝复合陶瓷制成的人工关节 - Google Patents
用氧化锆－氧化铝复合陶瓷制成的人工关节 Download PDFInfo
- Publication number
- CN1226053C CN1226053C CNB01802307XA CN01802307A CN1226053C CN 1226053 C CN1226053 C CN 1226053C CN B01802307X A CNB01802307X A CN B01802307XA CN 01802307 A CN01802307 A CN 01802307A CN 1226053 C CN1226053 C CN 1226053C
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- China
- Prior art keywords
- zirconia
- artificial joint
- joint
- composite ceramics
- bone member
- 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.)
- Expired - Fee Related
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- 239000002131 composite material Substances 0.000 title claims abstract description 88
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- 229910000422 cerium(IV) oxide Inorganic materials 0.000 claims abstract description 11
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Abstract
一种用氧化锆-氧化铝复合陶瓷制成的人工关节，其包含第一骨构件和第二骨构件，第二骨构件的一端与第一骨构件的一部分滑动接合，从而形成关节部分，其中至少一个第一骨构件和第二骨构件是用氧化锆-氧化铝复合陶瓷形成的，该复合陶瓷包含由氧化锆颗粒组成的基质相和，分散于其中的，由氧化铝颗粒组成的第二相，该氧化锆颗粒含有作为稳定剂的二氧化铈，二氧化铈的量使得基质相主要由四方晶形的氧化锆组成，且氧化锆-氧化铝复合陶瓷具有0.1-1μm，优选0.1-0.8μm，特别优选0.1-0.65μm的平均粒径。该人工关节可长期提供具有高度可靠性的关节的良好运动。
Description
技术领域
本发明涉及一种用氧化锆-氧化铝复合陶瓷制成的人工关节，其具有极好的耐磨性和较高的机械强度，且能够长期提供具有高度可靠性的，良好的关节运动和活动。
背景技术
在过去，人们已经将人工关节用于恢复患者受损关节或关节炎性关节的运动和活动。例如，传统的人工髋关节是由超高分子量聚乙烯的髋臼杯状结构及钴-铬合金或陶瓷，如氧化铝或氧化锆的骨构件组成的。该骨构件有一个基本为球形的头，其与髋臼杯状结构的内表面滑动接合，从而提供人工髋关节的关节运动。当使用聚乙烯与金属或陶瓷材料的组合物时，聚乙烯的磨损量比金属或陶瓷材料的大得多。在近几年中，报道了陶瓷材料，特别是氧化锆的使用可有效减少聚乙烯的磨损量。
另一方面，当长期使用人工关节时，可从人工关节产生精细的磨损碎屑。例如，当产生大量的聚乙烯磨损碎屑时，它可引起下述的严重问题。即，因为聚乙烯的磨损碎屑是亚微米到微米级粒径的精细粉末，因此它们可导致骨质溶解，骨质溶解是体内人工关节周围产生的骨溶解现象。此外，聚乙烯的磨耗量导致人工关节的松弛。因此，从最初进行手术直到大约10-15年后，需要用一个新的人工髋关节代替所用的人工髋关节。
作为一种传统的人工关节，例如，美国专利6,241,773公开了一种用氧化铝陶瓷制成的生物医学制品。此氧化铝陶瓷包含具有99.95％或更高纯度，及100ppm或更少氧化钙或氧化镁的氧化铝。该氧化铝陶瓷具有极好的耐磨性和600MPa或更高的三点弯曲强度。然而，普遍的观点认为氧化铝陶瓷机械性能的改变相对较大。因此，从长期提供一种具有高度可靠性的，稳定的关节运动的角度看，仍然有足够大的改进空间。除此之外，还存在这样一种问题，即它难以稳定地提高上述氧化铝陶瓷的产率。
另一方面，本发明人在日本专利[早期]公开号第11-228221中提出了一种用于生物用途的氧化锆-氧化铝复合陶瓷烧结体。该陶瓷烧结体是由氧化锆颗粒的第一相和氧化铝颗粒的第二相构成的，其中氧化锆颗粒的第一相含有作为四方晶形氧化锆稳定剂的二氧化铈和二氧化钛。此陶瓷烧结体是一种多孔结构，与传统的磷灰石相比，其具有150GPa的弹性模数，和较高的弯曲强度(170MPa)。然而，为了能在长期体内使用人工关节时增加耐磨性并提供平滑的关节运动，传统的人工关节还有足够大的，进一步改进的空间。
发明概述
本发明主要是提供一种用氧化锆-氧化铝复合陶瓷制成的人工关节，其可获得摩擦系数较低的，平滑的关节运动，同时通过改良氧化锆-氧化铝复合陶瓷材料的结构而增加耐磨性，减少所产生的磨损碎屑量。
即，本发明的人工关节包含第一骨构件和第二骨构件，第二骨构件与所述第一骨构件的一部分滑动接合，从而形成关节部分。至少一种第一和第二骨构件是用氧化锆-氧化铝复合陶瓷制成的。此氧化锆-氧化铝复合陶瓷包含氧化锆颗粒基质相和分散在基质相中的氧化铝颗粒第二相。该基质相的氧化锆颗粒含有作为稳定剂的二氧化铈，二氧化铈的含量使得基质相主要由四方晶形的氧化锆组成。本发明氧化锆-氧化铝复合陶瓷的特征在于，其平均粒径为0.1-1μm范围内，优选0.1-0.8μm，特别优选0.1-0.65μm。
在上述人工关节中，优选第一和第二骨构件均是用复合陶瓷制成的，且关节部分是通过复合陶瓷间的滑动接触而形成的。在这种情况下，当体内长期使用人工关节时，它可特别有效地减少所产生的磨损碎屑的量，并防止骨质溶解现象。
优选上述陶瓷复合物中第二相的量为25-40体积％范围内。
此外，在上述人工关节中，优选氧化铝颗粒部分分散在氧化锆颗粒内。
参考附图，并结合在下面详细描述的本发明的最佳方式，可更清楚地理解本发明由此所产生的附加特征和效果。
附图简述
图1是本发明实施例的氧化锆-氧化铝复合陶瓷人工关节的分解透视图；
图2是表示氧化锆-氧化铝复合陶瓷结构的SEM照片；和
图3是表示氧化锆-氧化铝复合陶瓷结构的SEM照片(高放大倍率)。
实现本发明的最佳方式
下面详细说明本发明用氧化锆-氧化铝复合陶瓷制成的人工关节。
图1表示本发明人工关节的实施方案。此人工关节包含一个球形的头20(第一骨构件)，和一个茎10，茎的一端可插入到孔21中，该孔21是在头20的下部形成的，以便支持该头，具有第一凹面31的内凹(cup)30(第二骨构件)，其中第一凹面31具有作为内表面的镜面抛光面，突出于外表面的螺钉42，其可用于在体内固定人工关节，和具有第二凹面41的外凹40，其中可嵌入内凹30。头的外表面是镜面抛光面，其可与内凹30的第一凹面31滑动接合，从而形成关节部分。在图1中，数字12和43分别表示在茎10和外凹40的外表面形成的多孔部分。该多孔部分可通过固定作用提高人工关节与骨之间的附着。
至少一个上述第一骨构件如头20，和上述第二骨构件如内凹30是用氧化锆-氧化铝复合陶瓷制成的，该复合陶瓷包含氧化锆颗粒基质相和分散在基质相中的氧化铝颗粒第二相。
本发明复合陶瓷中基质相的量为50体积％或更多。基质相的氧化锆颗粒主要是由四方晶形的氧化锆组成的。具体来说，基质相中四方晶形氧化锆的量为90体积％或更多，更优选95体积％或更多。当满足此条件时，按照应力导致的从四方晶到单斜晶的相转变可提高复合陶瓷的强度。
为了提供主要由四方晶形的氧化锆组成的基质相，氧化锆颗粒包含作为稳定剂的二氧化铈。特别是，为了获得上述量的四方晶形氧化锆，优选二氧化铈相对于氧化锆总量的量为8-12mol％，更优选10-12mol％。当该量小于8mol％时，不能获得足量亚稳相的四方晶。因此，由于单斜晶相对于四方晶的比例增加，可降低由应力导致的相转变所产生的机械强度。另一方面，当该量高于12mol％时，在高温开始出现稳定相的正方晶。因此，由于正方晶相对于四方晶的比例增加，在单斜晶的情况下，可降低应力导致的相转变。
如果需要，该基质相可进一步包含至少一种选自二氧化钛，氧化钙和氧化镁的物质。
因为二氧化钛可作为四方晶形氧化锆的稳定剂起作用，引起应力导致的相转变所需的临界应力值增加。因此，它可进一步提高复合陶瓷的强度。此外，二氧化钛还具有促进氧化锆颗粒的颗粒生长的作用。因此，如下所述，可使大量的氧化铝颗粒分散在氧化锆颗粒内。其可有效的，进一步提高复合陶瓷的强度。
为了获得上述效果，例如，优选二氧化钛相对于氧化锆总量的量为0.02-4mol％，特别优选0.05-1mol％。当二氧化钛的量小于0.02mol％时，不能获得由氧化锆颗粒生长所带来的充足效果。另一方面，当二氧化钛的量高于4mol％时，会很容易出现氧化锆颗粒的异常颗粒生长。因此，复合陶瓷的机械强度和耐磨性降低，不可能提供长期在体内稳定的关节运动。因而，需特别注意二氧化钛量的上限。
氧化镁和氧化钙可作为四方晶形氧化锆的稳定剂而起作用，从而提高复合陶瓷的强度和韧性。此外，由于基质相氧化锆颗粒与第二相氧化铝颗粒间的颗粒边界的调谐性提高，复合陶瓷的颗粒边界强度也提高。
为了获得上述效果，例如，优选至少一种氧化镁和氧化钙的量为0.005-0.1mol％范围内，特别优选0.05-0.1mol％。当该量小于0.005mol％时，不足以获得稳定剂的效果。另一方面，当该量为0.1mol％或更高时，可抑制四方晶形氧化锆的稳定。特别是，当使用氧化镁时，含镁复合氧化物的细长晶体可作为第三相出现，以致由于细长晶体的异常颗粒生长而降低了强度。因此，需特别注意氧化镁附加量的上限。
第二相的氧化铝颗粒分散在颗粒边界和/或基质相氧化锆颗粒的内部中。特别是，当氧化铝颗粒分散在氧化锆颗粒内时，氧化锆颗粒被加强，可提高复合陶瓷的强度。当氧化锆颗粒内的氧化铝颗粒数相对于复合陶瓷中全部氧化铝颗粒的比例为2％或更多时，此效果可被充分地证实。
优选复合陶瓷中第二相的量为0.5体积％或更多-50体积％或更少，特别优选25-40体积％。当氧化铝的量小于0.5体积％时，恐怕不足以提高复合陶瓷的耐磨性及氧化锆颗粒的强度。另一方面，当该量超过40体积％时，会出现氧化铝颗粒彼此烧结的趋势。因此，复合陶瓷强度的变化更大。此外，当该量超过50体积％时，复合陶瓷的基质相是由氧化铝颗粒组成的。在这种情况下，由于韧性的显著降低，不能获得本发明具有高度可靠性的人工关节。
为了将本发明的复合陶瓷，其中氧化铝颗粒的第二相和氧化锆颗粒的基质相是基本组分，应用于人工关节，本发明人已经发现，除上述组分外，还有许多非常重要的因素。即，如图2和3所示，本发明氧化锆-氧化铝复合陶瓷具有这样一种结构，其中极精细的氧化锆和氧化铝晶体颗粒均匀分散。特别是，用于人工关节的氧化锆-氧化铝复合陶瓷的平均粒径为0.1-1μm范围内，优选0.1-0.8μm，特别优选0.1-0.65μm。
当第一骨构件与第二骨构件在人工关节的关节部分滑动接合时，需抛光上述复合陶瓷的滑动面，从而得到超级镜面(例如，0.005μm Ra或更小的表面粗糙度)，以便获得平滑的关节运动和活动。当平均粒径超过1μm时，难以获得超级镜面，这是因为氧化锆颗粒或氧化铝颗粒很容易掉落。此外，当那些颗粒从体内长期使用的人工关节掉落的时候，耐磨性迅速降低。当平均粒径为0.8μm或更小时，那些颗粒在人工关节滑动面的掉落，即超级镜面显著降低。因此，它可为具有稳定机械性能的人工关节提供一种可作为人工关节材料的，具有高度可靠性的复合陶瓷。当平均粒径小于0.1μm时，在生产过程中，难以处理原料粉末，并充分增加了复合陶瓷的密度。
接下来，说明生产本发明氧化锆-氧化铝复合陶瓷的人工关节的方法的实施例。首先，制备作为起始材料的氧化锆和氧化铝颗粒的混合粉末，以便满足上述的配料量。如果需要，还可在上述配料量中加入二氧化钛，氧化钙，和/或氧化镁。对生产过程中的起始材料及研磨和混合条件没有限制。然而，需控制混合粉末的平均粒径，以便使在适当条件下通过烧结混合粉末而获得的烧结体具有上述平均粒径。
在用单向压和/或等静压成形模制混合粉末，从而获得具有所需形状的压制品后，在1400℃或更高-1600℃或更低的温度及大气压条件下，无压烧结该压制品。使用1400℃或更高温度的原因是可用非常长的烧结时间获得紧密的烧结体，在低于1400℃的温度即恐怕最终不能获得紧密的烧结体。此外，因为颗粒生长很容易发生在1600℃或更高的温度，因此当保持平均粒径小于1μm时，难以控制烧结过程。特别是，存在着局部发生氧化锆颗粒的异常颗粒生长的趋势。所获得的烧结体是用机械加工成所需形状的，且人工关节关节部分的滑动面是镜面-抛光的。因而，可获得本发明的人工关节。
顺便说一下，原料粉末的制备和烧结温度的控制对于获得具有0.1-0.65μm平均粒径范围内的复合陶瓷是非常重要的。即，混合粉末中氧化锆颗粒的比表面积为10-20m2/g范围内，氧化铝颗粒的平均粒径为0.5μm或更小范围内。考虑到混合粉末的模压性能，建议使用具有大约15m2/g比表面积的氧化锆颗粒及具有大约0.2μm平均粒径的氧化铝颗粒的混合粉末。
另一方面，当选择1500℃-1600℃范围内的烧结温度时，可获得具有1μm或更小平均粒径的复合陶瓷。然而，当期望生产具有0.1μm-0.65μm范围内精细平均粒径的复合陶瓷时，应选择1400℃或更高-1500℃或更低的烧结温度。因而，原料粉末制备和烧结温度控制的适当组合可稳定地提供具有超精细结构的复合陶瓷。
在本发明的人工关节中，至少一种第一和第二骨构件是用上述复合陶瓷制成的。例如，当其中一个第一和第二骨构件是用本发明的复合陶瓷制成时，另一个可用超高分子量的聚乙烯或主要含氧化铝的氧化物陶瓷制成。当使用复合陶瓷与聚乙烯的组合物时，人工关节的关节部分是通过复合陶瓷与聚乙烯间的滑动接触而形成的。类似地，当使用复合陶瓷与氧化物陶瓷的组合物时，人工关节的关节部分是通过复合陶瓷与氧化物陶瓷间的滑动接触而形成的。
当第一和第二骨构件均是用本发明的复合陶瓷制成的时，与使用聚乙烯的情况相比，长期体内使用人工关节所产生的关节部分的磨损量非常小。因此，它可避免骨质溶解的问题。此外，由于证实了复合陶瓷具有高强度和高韧性，因此与使用主要含氧化铝的氧化物陶瓷相比，它可进一步提高可靠性。因此，除人工髋关节之外，期望使用具有本发明复合陶瓷的第一和第二骨构件的人工关节作为人工膝关节，肩关节和肘关节，它们是在更苛刻的滑动条件下体内使用的。此外，因为本发明氧化锆-氧化铝复合陶瓷的人工关节具有极好的机械强度和耐磨性，因此可进一步延长其使用寿命。因此，从最初手术直到大约10-15年后，可避免进行用新的人工关节代替所用人工关节的手术。
实施例
(实施例1和对照实施例1-3)
将四方晶形的氧化锆粉末(四方晶形氧化锆的量：98体积％)，其含有相对于氧化锆总量10mol％的二氧化铈，0.05mol％的二氧化钛和0.05mol％的氧化钙，与相对于氧化锆-氧化铝复合陶瓷的总体积的30体积％的氧化铝粉末混合，获得混合粉末。用单向压和等静压成形模制混合粉末，获得具有所需形状的压制品后，在1400℃，大气压的条件下，无压烧结此压制品5小时。从而获得实施例1具有0.22μm平均粒径的氧化锆-氧化铝复合陶瓷。为了评估此复合陶瓷的耐磨性和摩擦系数，在有蒸馏水作为润滑剂的情况下，进行针盘磨损试验。
作为对照实施例，将具有1.43μm平均粒径的氧化铝烧结体用作对照实施例1。此外，将四方晶形的氧化锆烧结体用作对照实施例2，其具有0.19μm的平均粒径，并含有作为稳定剂的，相对于氧化锆总量3mol％的氧化钇。此外，将具有1.38平均粒径的氧化锆-氧化铝复合陶瓷用作对照实施例3，其是通过无压烧结与实施例1相同的混合粉末在1530℃5小时而得到的。
接下来，说明用于针盘试验的试验样品的形状。该针是一个具有5mm直径和15mm长度的圆柱状实心体，在圆柱状实心体的顶部有一个顶角为30°的圆锥。圆锥的顶端是用具有1.5mm直径的平面镜区形成的，其被用作滑动面。此滑动面的表面粗糙度为0.005μm Ra或更小。另一方面，该盘直径50mm，厚度8mm。与针接触的盘的滑动面是一种镜面抛光面，其具有0.005μm Ra或更小的粗糙度。该针和盘是用同种陶瓷材料制成的。例如，在实施例1中，将用本发明复合陶瓷制成的针和盘用于进行针盘试验。
将该针放在离盘中心，半径为22mm的圆周上后，如表1所示，以不同的盘转动速度(60mm/sec，120mm/sec)和不同的载荷(20N，40N，60N，80N，120N)进行针盘试验。滑动距离保持不变(25km)。因为针顶端的直径为1.5mm，施加在针顶端的最初摩擦力分别为11MPa(20N)，22MPa(40N)，33MPa(60N)，44MPa(80N)，66MPa(120N)。在各种试验条件下，重复该试验三次。因此，采用三次试验结果的平均值。所获得的试验结果在表1中列出。
表1
| 转动速度(mm/sec) | 载荷(N) | 比磨损率(mm3/Nm)×10-7 | 摩擦系数 | |
| 实施例1 | 60 | 20 | 0.0584 | 0.34 |
| 60 | 40 | 0.0155 | 0.37 | |
| 60 | 60 | 0.0584 | 0.29 | |
| 60 | 80 | 0.0965 | 0.22 | |
| 120 | 60 | 0.0986 | 0.38 | |
| 对照实施例1 | 60 | 20 | 1.88 | 0.30 |
| 60 | 40 | 1.35 | 0.38 | |
| 60 | 60 | 1.05 | 0.37 | |
| 60 | 80 | 0.824 | 0.36 | |
| 120 | 60 | 1.92 | 0.45 | |
| 对照实施例2 | 60 | 20 | 0.0997 | 0.27 |
| 60 | 40 | 0.0419 | 0.28 | |
| 60 | 60 | 0.126 | 0.35 | |
| 60 | 80 | 230 | 0.42 | |
| 120 | 60 | 480 | 0.49 | |
| 对照实施例3 | 60 | 80 | 74.7 | 0.39 |
| 60 | 120 | 177 | 0.41 |
使用最小刻度为0.01mg的比重计测量减少的针重量之后，用下列等式计算比磨损率(Wf)。
Wf＝(W1-W2)/P·L·ρ
其中
Wf：比磨损率(mm3/Nm)
W1：试验前针的干燥重量(g)
W2：试验后针的干燥总量(g)
P：载荷(N)
L：滑动距离(m)
ρ：试验样品的密度(g/mm3)
将该针在蒸馏水中超声波清洗10分钟后，在乙醇中清洗10分钟，然后在干燥器中充分干燥该针5天，测量该针的干燥重量。此外，使用通过阿基米德方法在水中测量的值作为各试验样品的密度，即，5.56×10-3g/mm3(实施例1，对照实施例3)，6.02×10-3g/mm3(对照实施例1)，和3.93×10-3g/mm3(对照实施例2)。
此外，摩擦系数(Cf)是用下列等式计算的。
Cf＝F/T
其中，
F：摩擦力(g)
(该值是通过测量施加在柱上的载荷而获得的，该柱用于支持具有应力仪的针)
T：总载荷(g)
(所施加的载荷及用于支持针的柱的总载荷)
从表1的结果可知，在实施例1中，在上述试验所施加载荷和转动速度的所有条件下，均获得小于1×10-8的极低的比磨损率。此外，摩擦系数也比较小。因此，在实施例1的复合陶瓷滑动接触的情况下，可获得非常平滑的滑动接合。另一方面，在对照实施例1中，在上述试验所施加载荷和转动速度的所有条件下，均获得1×10-7至1×10-8范围内的相对较小的比磨损率。然而，对照实施例1中的那些比磨损率比实施例1中的比磨损率要大。此外，在对照实施例2中，在施加直至60N载荷和60mm/sec转动速度的条件下，可获得极低的比磨损率，其水平与实施例1基本相同。然而，在80N载荷的条件下，突然发生1×10-5的相当大的磨损。此外，在60N或更小载荷及120mm/sec转动速度的条件下，发生如上所述的相当大的磨损。
在对照实施例2引起相当大磨损的试验条件下，作为润滑剂的蒸馏水的温度上升，大量的水蒸发。因此，推测由于摩擦而在滑动面产生了相当大的热。此外，从四方晶到单斜晶的晶体转变是通过拉曼光谱分析加以证实的。因此，发生基于低温降解的热相转变，这种转变是用氧化钇稳定的氧化锆所特有的。这些结果表明，使用氧化钇作为稳定剂的对照实施例2的复合陶瓷可靠性较差，不能被推荐用于在苛刻的滑动条件下提供关节运动的人工膝关节和肩关节。
此外，对照实施例3的氧化锆-氧化铝复合陶瓷与实施例1的组成相同，但与实施例1的平均粒径不同。在试验条件下，所施加的载荷相对较小，耐磨性水平基本上与实施例1的相同。然而，当所施加的载荷达到80N或更大时，与对照实施例2一样，突然发生相当大的磨损。由于此磨损量的显著增加，相信对照实施例3的复合陶瓷的平均粒径(＝1.38μm)超过1μm后，氧化锆与氧化铝颗粒间的界面强度降低，以致那些颗粒很容易由于摩擦而掉下来。因而，从实施例1与对照实施例3试验结果的比较可知，本发明氧化锆-氧化铝复合陶瓷的平均粒径对其耐磨性的影响较大。
(实施例2-5和对照实施例4)
将四方晶形的氧化锆粉末(四方晶形氧化锆的量：98体积％)，其含有相对于氧化锆总量10mol％的二氧化铈和0.05mol％的二氧化钛，与相对于氧化锆-氧化铝复合陶瓷总体积的35体积％的氧化铝粉末混合，获得混合粉末。通过单向压和等静压成形模制该混合粉末，获得所需形状的压制品后，如表2所示，在不同温度，大气压的条件下，无压烧结该压制品5小时。从而获得实施例2-5及对照实施例4的氧化锆-氧化铝复合陶瓷。在对照实施例4中，因为烧结温度为1600℃，所得复合陶瓷的平均粒径为1.65μm，其与本发明的复合陶瓷不相符。进行热处理，抛光所得烧结体的表面后，在没有将氧化锆和氧化铝区别开来的情况下，用扫描电子显微镜通过截距(infercept)方法测量平均粒径。
对按照与实施例1相似的方式获得的复合陶瓷进行针盘试验，然后计算比磨损率和摩擦系数。盘的转动速度为60mm/sec常量。此外，所施加的载荷为60N常量。所得结果连同复合陶瓷的平均粒径一起在表2中列出。
表2
| 烧结温度(℃) | 平均粒径(μm) | 比磨损率(mm3/Nm)×10-7 | 摩擦系数 | |
| 实施例2 | 1400 | 0.20 | 0.0320 | 0.30 |
| 实施例3 | 1450 | 0.35 | 0.0525 | 0.33 |
| 实施例4 | 1500 | 0.65 | 0.0789 | 0.31 |
| 实施例5 | 1550 | 0.98 | 1.53 | 0.38 |
| 对照实施例4 | 1600 | 1.65 | 35.6 | 0.39 |
从表2的结果可知，复合陶瓷的比磨损率主要取决于其平均粒径。在实施例2-4中，获得了小于1×10-8的极低的比磨损率。然而在实施例5中，该复合陶瓷具有大约1μm的平均粒径，其比磨损率增加至1.53×10-7。在对照实施例4中，该复合陶瓷具有1.65μm的平均粒径，其比磨损率比实施例5大约高二十倍，且比磨损率突然增加。对照实施例4的磨损量与使用聚乙烯和陶瓷组合物的传统的人工关节基本相同。作为具有1μm或更高平均粒径的复合陶瓷耐磨性降低的原因，相信是氧化锆与氧化铝颗粒间界面结构强度的降低导致掉落的颗粒量显著增加。
工业实用性
如上所述，因为本发明人工关节的第一和第二骨构件至少一种是用氧化锆-氧化铝复合陶瓷制成的，其中该复合陶瓷包括以二氧化铈作为稳定剂的氧化锆颗粒第一相，其主要由四方晶形的氧化锆组成，和分散于其中的氧化铝颗粒第二相，且复合陶瓷的平均粒径为0.1-1μm范围内，更优选0.1-0.8μm，该复合陶瓷的耐磨性增加，并具有高强度和高韧性。因此，可提供一种使用寿命延长的极好的人工关节，并由此避免从最初手术直到10-15年后，用新的人工关节代替所用人工关节的手术。特别是，与使用传统人工关节的情况相比，因为本发明的人工关节可在更苛刻的条件下保持良好的耐磨性，因此其也期望用于人工膝关节和肩关节中。
Claims (8)
1.一种包含第一骨构件和第二骨构件的人工关节，第二骨构件与所述第一骨构件滑动接合，从而形成关节部分，至少一种所述的第一和第二骨构件是用氧化锆-氧化铝复合陶瓷制成的，该复合陶瓷包括：
氧化锆颗粒基质相，其中含有占所述氧化锆颗粒总量8-12mol％的二氧化铈，以及占所述氧化锆颗粒总量0.02-4mol％的二氧化钛，从而使所述基质相主要由四方晶形的氧化锆组成；和
分散在所述基质相中的氧化铝颗粒的第二相，
其中所述第二相在所述复合陶瓷中的含量范围为25-40vol％，而所述复合陶瓷的平均粒径范围为0.1-0.35μm。
2.如权利要求1所述的人工关节，其中一个所述的第一和第二骨构件是用所述复合陶瓷制成的，另一个是用聚乙烯制成的，且其中所述的关节部分是通过所述复合陶瓷与聚乙烯间的滑动接触而形成的。
3.如权利要求1所述的人工关节，其中所述第一和第二骨构件均是用所述复合陶瓷制成的，且其中所述关节部分是通过所述复合陶瓷间的滑动接触而形成的。
4.如权利要求1所述的人工关节，其中一个所述的第一和第二骨构件是用所述复合陶瓷制成的，另一个是用主要成分为氧化铝的氧化物陶瓷制成的，且其中所述的关节部分是通过所述复合陶瓷与所述氧化物陶瓷间的滑动接触而形成的。
5.如权利要求1所述的人工关节，其中所述的氧化铝颗粒部分分散在所述氧化锆颗粒的内部。
6.如权利要求1所述的人工关节，其中所述的基质相进一步包含至少一种选自氧化钙和氧化镁的物质。
7.如权利要求1所述的人工关节，其中所述的基质相含有10-12mol％的二氧化铈。
8.如权利要求1所述的人工关节，其中所述的基质相含有0.05-1mol％的二氧化钛。
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| US20050272591A1 (en) * | 2004-03-23 | 2005-12-08 | Masahiro Nawa | ZrO2-Al2O3 composite ceramic material and production method therefor |
| JP4384571B2 (ja) * | 2004-09-15 | 2009-12-16 | 京セラ株式会社 | 高分子材料の物性値解析方法 |
| JP4761749B2 (ja) * | 2004-09-29 | 2011-08-31 | 京セラ株式会社 | 生体部材およびそれを用いた人工関節 |
| WO2006080741A1 (en) * | 2004-10-11 | 2006-08-03 | Lg Chem, Ltd. | Sintered bioactive ceramic composite implant and preparation thereof |
| WO2006080473A1 (ja) * | 2005-01-27 | 2006-08-03 | Kyocera Corporation | 複合セラミックス及びその製法 |
| US9078754B1 (en) * | 2005-04-29 | 2015-07-14 | Signal Medical Corporation | Harder-softer hard substance articulation for arthroplasty |
| US20070032877A1 (en) * | 2005-08-05 | 2007-02-08 | Whiteside Leo A | Coated ceramic total joint arthroplasty and method of making same |
| US20080195221A1 (en) * | 2007-01-22 | 2008-08-14 | Zimmer Gmbh | Implant and a method for partial replacement of joint surfaces |
| US10653527B1 (en) * | 2007-03-05 | 2020-05-19 | Ceramic Medical Products, L.L.C. | Ceramic with metal/alloy coating |
| US8834576B1 (en) * | 2007-03-05 | 2014-09-16 | Louis A. Serafin, Jr. | Ceramic with metal/alloy coating |
| DE102007020473B4 (de) * | 2007-04-27 | 2016-03-03 | Ceramtec Gmbh | Keramischer Werkstoff, seine Verwendung und Sinterformkörper |
| CN101934096B (zh) * | 2009-06-25 | 2013-08-21 | 四川大学 | Ca-P生物微晶玻璃复合的纳米生物陶瓷及其制备方法 |
| KR20120110129A (ko) * | 2009-12-28 | 2012-10-09 | 파나소닉 주식회사 | 지르코니아-알루미나 복합 세라믹 재료의 제조 방법, 지르코니아-알루미나 복합 과립화 분말, 및 지르코니아 비즈 |
| JP5885354B2 (ja) * | 2010-06-08 | 2016-03-15 | スミス アンド ネフュー インコーポレーテッド | インプラントの構成要素および方法 |
| US11504152B2 (en) * | 2018-06-11 | 2022-11-22 | RELIGN Corporation | Arthroscopic devices and methods |
| CN110194659A (zh) * | 2019-06-12 | 2019-09-03 | 南京赛诺特斯材料科技有限公司 | 一种基于纳米氧化锆和氧化铝复合陶瓷的口腔修复材料 |
| JPWO2022004242A1 (zh) * | 2020-07-02 | 2022-01-06 | ||
| KR102621402B1 (ko) * | 2021-12-10 | 2024-01-05 | 이부락 | 인공고관절 |
| WO2023106901A1 (ko) * | 2021-12-10 | 2023-06-15 | 이부락 | 인공고관절 |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4690911A (en) * | 1983-10-20 | 1987-09-01 | Hitachi Chemical Co., Ltd. | Zirconia ceramics and process for producing the same |
| AU6847390A (en) * | 1989-12-28 | 1991-07-04 | Tosoh Corporation | Alumina-zirconia composite sintered product and method for making the same |
| GB2305430B (en) * | 1995-09-21 | 1997-08-27 | Matsushita Electric Works Ltd | Zirconia based ceramic material and process of making the same |
| JP2945935B2 (ja) * | 1996-10-01 | 1999-09-06 | 松下電工株式会社 | ジルコニア系複合セラミック焼結体、及びその製法 |
| JPH1156884A (ja) * | 1997-08-28 | 1999-03-02 | Kyocera Corp | 人工股関節 |
| DE19752674B4 (de) * | 1997-11-28 | 2006-12-14 | Ceramtec Ag Innovative Ceramic Engineering | Künstliches Gelenk einer Prothese |
| JP3648968B2 (ja) * | 1998-02-09 | 2005-05-18 | 松下電工株式会社 | 生体用ジルコニア系複合セラミック焼結体 |
| US6974640B2 (en) * | 2001-07-09 | 2005-12-13 | The University Of Connecticut | Duplex coatings and bulk materials, and methods of manufacture thereof |
-
2001
- 2001-08-06 CN CNB01802307XA patent/CN1226053C/zh not_active Expired - Fee Related
- 2001-08-06 KR KR10-2002-7004301A patent/KR100506469B1/ko not_active IP Right Cessation
- 2001-08-06 TW TW090119110A patent/TW537907B/zh not_active IP Right Cessation
- 2001-08-06 DE DE60110197T patent/DE60110197T2/de not_active Expired - Fee Related
- 2001-08-06 EP EP01954464A patent/EP1228774B1/en not_active Expired - Lifetime
- 2001-08-06 WO PCT/JP2001/006744 patent/WO2002011780A1/ja active IP Right Grant
- 2001-08-06 US US10/110,043 patent/US20020198602A1/en not_active Abandoned
Also Published As
| Publication number | Publication date |
|---|---|
| DE60110197T2 (de) | 2006-03-09 |
| EP1228774A1 (en) | 2002-08-07 |
| WO2002011780A1 (fr) | 2002-02-14 |
| KR100506469B1 (ko) | 2005-08-05 |
| EP1228774B1 (en) | 2005-04-20 |
| CN1386067A (zh) | 2002-12-18 |
| KR20020059603A (ko) | 2002-07-13 |
| US20020198602A1 (en) | 2002-12-26 |
| TW537907B (en) | 2003-06-21 |
| EP1228774A4 (en) | 2004-03-17 |
| DE60110197D1 (de) | 2005-05-25 |
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