CN101947149B - 多层壳芯复合结构件组成的人工髋关节 - Google Patents

多层壳芯复合结构件组成的人工髋关节 Download PDF

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Publication number
CN101947149B
CN101947149B CN2010102991477A CN201010299147A CN101947149B CN 101947149 B CN101947149 B CN 101947149B CN 2010102991477 A CN2010102991477 A CN 2010102991477A CN 201010299147 A CN201010299147 A CN 201010299147A CN 101947149 B CN101947149 B CN 101947149B
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China
Prior art keywords
artificial
shell
hip joint
ceramic
core composite
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CN2010102991477A
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CN101947149A (zh
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李亚东
李亚军
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Suzhou Ding an Technology Co., Ltd.
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李亚东
李亚军
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Priority to CN2010102991477A priority Critical patent/CN101947149B/zh
Publication of CN101947149A publication Critical patent/CN101947149A/zh
Priority to US13/878,234 priority patent/US9333083B2/en
Priority to PCT/CN2011/076625 priority patent/WO2012045248A1/zh
Application granted granted Critical
Publication of CN101947149B publication Critical patent/CN101947149B/zh
Priority to US15/095,164 priority patent/US10327903B2/en
Priority to US15/095,163 priority patent/US10010420B2/en
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Abstract

本发明公开了一种多层壳芯复合结构件组成的人工髋关节，包括互相配合的人工髋臼和人工股骨头，其特征在于：所述人工髋臼具有多层壳芯复合结构，由陶瓷髋臼内衬、过渡层和多孔金属、多孔合金或多孔增韧陶瓷髋臼外壳构成；所述人工股骨头具有多层壳芯复合结构，由陶瓷球壳层、过渡层和增韧陶瓷内芯构成。本发明的人工髋臼内衬和人工股骨头球壳层具有高硬、耐蚀和耐磨性能；人工髋臼外壳层和股骨头内芯层具有高强韧、耐冲击性能；过渡层采用组成介于壳层、内芯层材料之间的梯度复合材料，具有增加壳层与内芯层间结合强度和降低壳层与内芯层间界面应力等功能，人工髋关节具有长寿命、高可靠和高性能等特点。

Description

多层壳芯复合结构件组成的人工髋关节
技术领域
本发明属于医学假肢体领域，涉及一种人工髋关节，特别是包含多层壳芯复合结构的人工髋臼和多层壳芯复合结构的人工股骨头两种构件的人工髋关节。
背景技术
人工髋关节置换术已成为治疗髋关节创伤、老化、炎症和病变，减轻患者疼痛，恢复患者活动能力和提高患者生活质量最有效的途径。人工髋关节的活动功能是通过人工髋臼和人工股骨头间的滑动来实现的。
现有的人工髋臼主要包括组合式和一体式两种结构。组合式人工髋臼主要由金属臼杯(髋臼外衬)与超高分子量聚乙烯内衬或陶瓷内衬机械组合而成，因此，金属臼杯与内衬之间仍然留有微小间隙，在使用中会有微动产生并生成磨损微粒，这些微粒被巨噬细胞吞噬后所产生的溶骨素将最终导致人工髋关节周围骨溶解，增加术后并发症(包括疼痛、撞击、脱位、松动或下沉等)的出现。同时，在微创手术过程中，狭小的施术空间等原因会造成组合式髋臼安装困难。
一体式人工髋臼避免了上述组合式人工髋臼存在的金属臼杯与内衬结合不牢固，防旋、防脱效果不理想等问题。但是，金属臼杯与超高分子量聚乙烯内衬组成的一体式人工髋臼因要保证超高分子量聚乙烯有足够的厚度，人工股骨头直径一般为28mm，致使患者髋关节的活动度受到限制，人工股骨柄(颈)易与髋臼边缘发生撞击，造成髋臼松动、甚至容易出现脱位。全金属一体式人工髋臼与人工股骨头界面磨损可带来金属离子溶出，金属磨损微粒(如：铝、钛、钴、铬)可能致癌，且可能导致造血系统障碍及影响智力水平，因此，在孕妇、儿童或患有血液系统疾病、肝肾功能不全等人群中不易使用。全陶瓷一体式人工髋臼虽然具有良好的组织相容性，避免了具有潜在毒性的金属离子的释放，而且表面硬度高，具有很好的耐磨性，但是，陶瓷的断裂韧性低，抗冲击承载能力差，临床应用风险大。
如何有效避免现有人工髋臼在临床使用中存在的磨损微粒、金属离子溶出和脆性断裂等问题，迄今没有理想的解决办法。
长期以来，钴基、钛基等合金作为人工股骨头材料虽然已得到普遍采用，但是，同样存在全金属一体式人工髋臼一样的风险。为此，美国专利6,241,773，日本专利No.2579212分别公开了一种用高纯氧化铝陶瓷制成的人工股骨头。但是，氧化铝陶瓷脆性大、断裂韧性低，抗冲击承载能力差，氧化铝陶瓷股骨头在临床使用中易发生脆性断裂。显然，单一的氧化铝陶瓷不能成为用于人工髋关节各组成构件的理想材料。2005年，日本松下电工株式会社公开了一种用氧化锆-氧化铝复合陶瓷制成的人工髋关节(CN1386067A)，该复合陶瓷包含由四方晶形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。虽然，复合陶瓷的断裂韧性得到了明显改善，但是与高纯氧化铝相比机械强度(硬度)、耐磨性和相的稳定性降低，难以提供体内持久稳定的关节运动。现有人工髋关节离“终身使用”尚存甚大距离，远不符合广大患者的夙愿。
发明内容
本发明的目的是，提供一种多层壳芯复合结构件组成的人工髋关节，从根本上避免现有人工髋关节使用中因活动关节界面产生的磨损微粒所导致的人工髋关节无菌性松动或下沉、金属离子过敏、股骨头脱位和脆性断裂等现象，获得一种具有长寿命、高可靠和高性能等特点的人工髋关节，减少再次手术率。
为达到上述目的，本发明采用的技术方案是：一种多层壳芯复合结构件组成的人工髋关节，包括互相配合的人工髋臼和人工股骨头，所述人工髋臼具有多层壳芯复合结构，由陶瓷髋臼内衬、过渡层和多孔金属、多孔合金或多孔增韧陶瓷髋臼外壳构成；所述人工股骨头具有多层壳芯复合结构，由陶瓷球壳层、过渡层和增韧陶瓷内芯构成。
上述技术方案中，具有多层壳芯复合结构的人工髋臼和多层壳芯复合结构的人工股骨头两种滑动配合构件形成关节，多层壳芯复合结构人工髋臼是一种具有外壳层、过渡层和内衬(芯)层多层组织结构的一体式人工髋臼，其内衬用陶瓷制成，外壳层用多孔金属(合金)或多孔增韧陶瓷制成，经高温烧结而成的多层壳芯复合结构人工髋臼具有高硬(HV＞1900)、耐磨、耐蚀、表面光洁度高的陶瓷内衬；冲击韧性高(KIC＞10MPa·m-1/2)、抗弯强度和承受冲击载荷能力强的多孔金属(合金)或多孔增韧陶瓷外壳层；髋臼外壳层和内衬层之间结合强度高。
人工髋臼外壳层的多孔金属(合金)或多孔增韧陶瓷具有类似松质骨的孔结构和孔形貌，三维气孔率在50～80％范围内，孔直径在50～250μm范围内，有利于诱导骨组织和血管生长，得到广泛的骨性支持，三维连通的孔结构更加有利于骨组织的迅速长入形成强的附着，获得更高的骨界面剪切强度，有利于人工髋臼长期的稳定性。同时，多孔金属(合金)或多孔增韧陶瓷不仅具有生物相容性，而且有与松质骨更为相似的弹性模量。
上述技术方案中，人工股骨头为陶瓷球壳层、过渡层和增韧陶瓷内芯复合制成的人工股骨头，经高温烧结而成的多层壳芯复合结构人工股骨头具有高硬(HV＞1900)、耐磨、耐蚀、表面光洁度高的陶瓷外球壳层；冲击韧性高(KIC＞10MPa·m-1/2)、抗弯强度和承受冲击载荷能力强的增韧陶瓷内芯复合组织结构；陶瓷外球壳层与内芯具有结合强度高，抗冲击力学承载能力强和持久稳定性好等优点。
根据实际使用材料的性质和多层壳芯复合结构要求，所述人工髋臼中的过渡层为一层或多层结构；所述人工股骨头中的过渡层为一层或多层结构。过渡层采用多层结构的目的是，改善髋臼内衬与髋臼外壳间、人工股骨头与内芯间的物理、化学和力学性能的匹配效果，减小上述层间的界面应力和进一步提高层间的结合强度。
上述技术方案中，各层的厚度可以为0.1～20mm。
上述技术方案中，所述人工髋臼中的过渡层采用由髋臼内衬、髋臼外壳材料混合的粉末经烧结而成的复合材料；所述人工股骨头中的过渡层采用由壳层、内芯材料混合的粉末经烧结而成的复合材料。
所述髋臼内衬和人工股骨头这两种构件为采用粉末注射成形方法制成的生坯经烧结成形获得的多层壳芯复合结构，其中所使用的陶瓷包括：超细氧化铝、氧化锆、碳化铬、氮化硅、碳化硅、碳化钛、碳化锆、氮化锆、碳化钽、碳化钨或它们中多种的混合物烧结而成的氧化物或非氧化物陶瓷；金属或合金包括：铌、锆、钛、钽、钴、钼、钒、铬、铝、镁、它们中多种的混合物或不锈钢粉末经烧结而成的金属或合金；增韧陶瓷为由上述陶瓷、金属所组成的金属基、陶瓷基金属陶瓷或氧化锆、晶须或纤维增韧陶瓷。
进一步的技术方案，在所述髋臼外壳表面设有多头螺旋凹纹或螺旋凸纹。上述技术进一步增加了人工髋臼外壳与骨组织的接触面积，产生更高的抓持力，使髋臼和骨组织之间的剪切应力转换成为压应力，提高了人工髋臼植入时的初始稳定和人工髋关节置换术的成功率。
由于上述技术方案运用，本发明与现有技术相比具有下列优点：
1.本发明的人工髋臼采用多层壳芯复合结构，与现有一体式人工髋臼相比，髋臼内衬不仅采用了硬度高、耐磨好的陶瓷材料，而且还可以大大减小内衬厚度，因此，可以在提高使用寿命的前提下，采用直径为36mm甚至更大的人工股骨头，故用其组成的人工髋关节的撞击率、脱位率必将明显降低，患者髋关节的活动度可以更大。这是现有组合式和一体式人工髋臼所难以同时兼顾获得的。
2.本发明的多层壳芯复合结构人工髋臼外壳表面所采用的多孔金属(合金)或多孔增韧陶瓷层以及外壳表面设有的多头螺旋凹纹或螺旋凸纹可以更好地保证人工髋臼与骨组织之间形成良好的骨性接连，进一步提高人工髋臼与骨组织之间的接触面，提高人工髋关节植入的初期稳定性。
3.多层壳芯复合结构人工股骨头不仅能够有效避免现有陶瓷股骨头因脆性而易导致临床使用时突然发生开裂的危险，而且可以避免现有氧化锆-氧化铝复合陶瓷人工股骨头表面硬度低、耐磨性和相的稳定性低(与氧化铝人工股骨头相比)，难以提供体内持久稳定的关节运动等缺陷。
4.本发明的多层壳芯复合结构件组成的人工髋关节不仅具有良好的组织相容性，显著减少了磨损微粒的形成，避免了具有潜在毒性的金属离子释放和人工髋关节无菌性松动或下沉现象的出现，而且人工髋臼和人工股骨头的关节活动表面硬度高，具有很好的耐磨性，可抵抗研磨性磨损和第三体磨损，具有抗弯强度、断裂韧性高，抗冲击承载能力好等优点；同时，由人工髋臼和人工股骨头所构成的陶瓷关节活动表面具有良好的亲水性，能使摩擦界面保持表面润滑作用，减少粘着性磨损，特别适用于年轻及运动量大的患者；并且具有抗冲击力学承载能力强和持久稳定性好等优点。
附图说明
图1、2是本发明实施例的两种多层壳芯复合结构件组成的人工髋关节的分解透视示意图；
图3、4是本发明实施例的设有表面多头螺旋凸纹的两种多层壳芯复合结构人工髋臼的局部剖面图；
图5、6是本发明实施例的设有表面多头螺旋凹纹的两种多层壳芯复合结构人工髋臼的局部剖面图；
图7～11是本发明实施例的五种多层壳芯复合结构人工股骨头的剖面图；
图12是本发明实施例中人工股骨头的制备方法流程示意图。
具体实施方式
下面结合附图及实施例对本发明作进一步描述：
图1、2给出的是本实施例涉及的多层壳芯复合结构件组成的人工髋关节的分解透视图。此人工髋关节包含一个多层壳芯复合结构人工髋臼1和一个多层壳芯复合结构人工股骨头2两个构件，其中，人工髋臼1有两种结构形式，即外壳层1-4的表面设有多头螺旋凸纹(见图1)和凹纹(见图2)，可以根据使用要求选择。人工髋臼1与股骨头2组成一个由人工髋臼内衬层1-1凹球面和股骨头壳层2-1球面滑动配合的活动关节，其中人工髋臼内衬层1-1凹球面和股骨头壳层2-1球面均被加工成镜面并可进行相对自由滑动。人工髋关节植入时，人工髋臼1被固定在人体原骨髋臼处，股骨头2被固定在与人体股骨髓腔配合的人工股骨柄的颈部，然后，将股骨头2安装在人工髋臼内衬层1-1内，以实现人工髋关节的活动功能。
实施例一：
一种多层壳芯复合结构件组成的人工髋关节中的多层壳芯复合结构人工髋臼，它由高纯超细氧化铝陶瓷髋臼内衬层1-1、氧化铝基(25vol％铌)金属陶瓷过渡层1-2、氧化铝基(65vol％铌)金属陶瓷过渡层1-3和铌多孔金属髋臼外壳层1-4四部分组成，其髋臼外壳层1-4的表面设有多头螺旋凸纹(见图3)或多头螺旋凹纹(见图4)两种形式，可以根据使用要求选择。高纯超细氧化铝粉末的纯度大于99.9wt％，颗粒尺寸为0.5～10μm；铌金属粉末的纯度大于99.8wt％，颗粒尺寸为0.5～20μm。所述的高纯超细氧化铝陶瓷髋臼内衬层1-1与氧化铝基(25vol％铌)金属陶瓷过渡层1-2、氧化铝基(65vol％铌)金属陶瓷过渡层1-3和铌多孔金属髋臼外壳层1-4均采用多材料粉末共注射技术逐层注射成一体，在髋臼开口边缘处内衬层1-1、过渡层1-2、1-3和外壳层1-4四层平行重叠。
实施例二：
一种多层壳芯复合结构件组成的人工髋关节中的多层壳芯复合结构人工髋臼，它由高纯超细氧化铝陶瓷髋臼内衬层1-1、Ti6Al4V-60vol.％Al2O3过渡层1-2、Ti6Al4V-20vol.％Al2O3过渡层1-3和Ti6Al4V髋臼外壳层1-4四部分组成，其髋臼外壳层1-4的表面设有多头螺旋凸纹(图5)或多头螺旋凹纹(图6)两种形式，可以根据使用要求选择。高纯超细氧化铝粉末的纯度大于99.9wt％，颗粒尺寸为0.5～10μm；Ti6Al4V粉末的纯度大于99.0wt％，颗粒尺寸为5～25μm。所述的高纯超细氧化铝陶瓷髋臼内衬层1-1与Ti6Al4V-60vol.％Al2O3过渡层1-2、Ti6Al4V-20vol.％Al2O3过渡层1-3和Ti6Al4V髋臼外壳层1-4均采用多材料粉末共注射技术逐层注射成一体，在髋臼开口边缘处高纯超细氧化铝陶瓷髋臼内衬层1-1完全包覆过渡层1-2、1-3和外壳层1-4。
实施例三：
一种多层壳芯复合结构件组成的人工髋关节中的多层壳芯复合结构人工股骨头，它由高纯超细氧化铝陶瓷球壳层2-1、ZrO2(3Y2O3)-80wt.％Al2O3增韧陶瓷过渡层2-5和ZrO2(3Y2O3)-20wt.％Al2O3增韧陶瓷内芯2-2三部分组成。高纯超细氧化铝粉末的纯度大于99.9wt％，颗粒尺寸为0.5～10μm；ZrO2粉末的纯度大于99.8wt％，颗粒尺寸为0.5～10μm。所述的高纯超细氧化铝陶瓷球壳层2-1、ZrO2(3Y2O3)-80wt.％Al2O3增韧陶瓷过渡层2-5和ZrO2(3Y2O3)-20wt.％Al2O3增韧陶瓷内芯2-2均采用多材料粉末共注射技术逐层注射成一体，具体多层壳芯结构如图7～11，可以根据使用要求选择。
本实施例中，人工股骨头的制备方法，参见附图12所示，(1)分别配制高纯超细氧化铝粉末、ZrO2(3Y2O3)-80wt.％Al2O3增韧陶瓷复合粉末和ZrO2(3Y2O3)-20wt.％Al2O3增韧陶瓷粉末注射成形喂料。配制好的粉末分别与聚醛树脂基粘结剂(89wt.％聚甲醛、5wt.％高密度聚乙烯和6wt.％其它粘结助剂)混合并在180℃条件下混炼2.5h，获得装载量(固含量)大于55Vol.％的聚醛体系喂料。
(2)采用三套模具先后对多层壳芯复合结构股骨头的内芯、过渡层和球壳层进行注射成形，得到多层壳芯复合结构股骨头生坯。注射温度为170～180℃，注射压力为110～130MPa，保压压力为70～80MPa，冷却时间为3～4min。
(3)对多层壳芯复合结构股骨头生坯的球壳面和内芯上的锥孔进行必要的外形修整。
(4)将多层壳芯复合结构股骨头坯放在110～120℃气氛炉中催化脱脂，采用硝酸作为脱脂催化剂，脱脂载气为氮气，脱脂时间为5h。
(5)将脱脂后的多层壳芯复合结构股骨头生坯放入气氛保护热等静压炉中控制烧结，烧结温度1450℃，35MPa和保温时间1h。
(6)根据产品尺寸要求，对烧结体的球壳面和锥孔进行微量加工；
(7)最后，采用SiC超细粉和金刚石研磨膏对球壳面进行抛光，得到具有一定表面光洁度和锥孔与股骨柄尺寸配合良好的多层壳芯复合结构股骨头。
实施例四：
一种多层壳芯复合结构件组成的人工髋关节中的多层壳芯复合结构人工股骨头，它由高纯超细氧化铝陶瓷球壳层2-1、Al2O3-30vol％(Ce-TZP)增韧陶瓷过渡层2-5和Al2O3-70vol％(Ce-TZP)增韧陶瓷内芯2-2三部分组成。高纯超细氧化铝粉末的纯度大于99.9wt％，颗粒尺寸为0.5～10μm；ZrO2粉末的纯度大于99.8wt％，颗粒尺寸为0.5～10μm。所述的高纯超细氧化铝陶瓷球壳层2-1、Al2O3-30vol％(Ce-TZP)增韧陶瓷过渡层2-5和Al2O3-70vol％(Ce-TZP)增韧陶瓷内芯2-2均采用多材料粉末共注射技术逐层注射成一体，具体多层壳芯结构如图7～11，可以根据使用要求选择。

Claims (4)

1.一种多层壳芯复合结构件组成的人工髋关节，包括互相配合的人工髋臼和人工股骨头，其特征在于：所述人工髋臼具有多层壳芯复合结构，由陶瓷髋臼内衬、过渡层和多孔增韧陶瓷髋臼外壳构成，所述人工髋臼中的过渡层为多层结构；所述人工股骨头具有多层壳芯复合结构，由陶瓷球壳层、过渡层和增韧陶瓷内芯构成；
所述人工髋臼和人工股骨头这两种构件为采用粉末注射成形方法制成的生坯经烧结成形获得的多层壳芯复合结构，其中所使用的陶瓷包括：超细氧化铝、氧化锆、碳化铬、氮化硅、碳化硅、碳化钛、碳化锆、氮化锆、碳化钽、碳化钨或它们中多种的混合物烧结而成的氧化物或非氧化物陶瓷；增韧陶瓷为氧化锆、晶须或纤维增韧陶瓷。
2.根据权利要求1所述的多层壳芯复合结构件组成的人工髋关节，其特征在于：所述人工股骨头中的过渡层为一层或多层结构。
3.根据权利要求2所述的多层壳芯复合结构件组成的人工髋关节，其特征在于：所述人工髋臼中的过渡层采用由髋臼内衬、髋臼外壳材料混合的粉末经烧结而成的复合材料；所述人工股骨头中的过渡层采用由壳层、内芯材料混合的粉末经烧结而成的复合材料。
4.根据权利要求1所述的多层壳芯复合结构件组成的人工髋关节，其特征在于：在所述髋臼外壳表面设有多头螺旋凹纹或螺旋凸纹。
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