CN108201635A - 一种关节软骨下骨修复用支架 - Google Patents
一种关节软骨下骨修复用支架 Download PDFInfo
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- CN108201635A CN108201635A CN201611183811.5A CN201611183811A CN108201635A CN 108201635 A CN108201635 A CN 108201635A CN 201611183811 A CN201611183811 A CN 201611183811A CN 108201635 A CN108201635 A CN 108201635A
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Abstract
一种关节软骨下骨修复用支架，自上而下由多孔盐层和多孔金属材料层构成，多孔金属材料层为梯度多孔金属材料层。该种结构的支架有效地实现了人工关节软骨下骨仿生，使软骨下骨能承受复杂、大的载荷，并具有良好的缓冲功能，实现了良好的力的传递，强度高于多孔非金属支架，克服了单一孔隙的高孔隙率多孔金属材料刚性不足的问题，多孔盐层又有利于与软骨层融合，该种支架还具有良好的渗流特性，其孔径设计既有利于细胞、营养液迁移，又有助于维持关节内的液体具有适当的压力；该种支架的孔径、材料设计又有助于细胞的迁移、寄居、分化、增值，它是真正的关节软骨下骨修复、再生支架。
Description
技术领域
本发明涉及假体，具体涉及一种关节软骨下骨修复用支架。
背景技术
人体关节具有复杂的结构，软骨下骨是关节的重要组成部分，人体运动时关节承受较大的复杂载荷，当运动时，关节承受的载荷甚至达到人的体重的7-9倍以上，这对关节软骨下骨提出了很高的要求。随着社会经济水平的提高，交通事故等严重创伤的发生率也在急速增加。在我国每年大约由于创伤引起的关节损伤大约影响数十万人的生活，每年大约有10万人需要进行人工关节置换术。疾病及社会老龄化造成的关节的发病率也在不断升高，骨性关节炎等均可引起关节的损伤或缺损，由此造成关节软骨下骨的损伤或缺损，临床上单纯关节软骨损伤比较少见，更多的是伴随软骨下骨的病变，如骨软骨炎病变引起的软骨下骨的坏死，软骨退变引起的软骨下骨的硬化等。目前治疗骨关节病所采用的人工全关节置换材料多为金属、陶瓷、超高分子量聚乙烯等硬质材料，随着使用年限的增长，容易产生材料失效、老化等问题，造成磨损、松动而导致术后并发症，使用年限短，且费用昂贵。为此，人们对关节软骨下骨修复用支架开展了很多研究。
CN103127553A一种纳米微米结构共存壳聚糖双层支架的制备方法介绍的骨/软骨修复支架的底层为三维微米壳聚糖支架，用于提供高孔隙率和力学强度，适合成骨细胞的生长，用于修复软骨下骨。
CN101219069A用于骨软骨修复的双层复合支架公开了一种用于骨软骨修复的双层复合支架，模拟软骨下骨层采用羟基磷灰石，磷酸三钙，聚醚醚酮，聚乳酸-聚羟基乙酸共聚物，聚羟基乙酸，聚乳酸，蚕丝蛋白中的一种或几种的混合物；模拟软骨下骨层的厚度为2mm -20mm，该层的孔隙率为50%-75%，其孔径为200μm -500μm。
CN102526809A一种用于骨软骨缺损修复的支架及其制备方法，该支架由具有孔隙的软骨层和具有孔隙的软骨下骨层构成，所述软骨层和软骨下骨层紧密结合为一体，其中软骨下骨层的材料为多孔钛或多孔氧化钛或多孔钛合金。
Porous tantalum biocomposites for osteochondral defect repair（E.H.Mrosek et al. Bone Joint Res. 2016；5:403-411)介绍了用多孔钽与自体骨膜复合进行了绵羊软骨-软骨下骨缺损的修复试验。结果表明，该结构未能有效促进软骨形成。
尽管人们开展了不少研究，但关节软骨下骨修复用支架的结构仍不合理，未能有效地仿生人体关节，软骨下骨用修复支架易于坍塌、损坏，其修复、再生效果不佳。
发明内容：
本发明的目的是提供一种结构合理，再生效果好的关节软骨下骨修复用支架。
本发明目的通过如下技术方案实现：
一种关节软骨下骨修复用支架，自上而下依次由多孔盐层和多孔金属材料层构成，所述多孔金属材料层为梯度多孔金属材料层。该种结构的材料有效地实现了人工关节软骨下骨仿生，避免了单一非金属材料强度不足的问题，并使软骨下骨能承受复杂、大的载荷，其中的多孔结构可使营养液、细胞传递，多孔盐层又有利于与软骨层融合，促进人工关节修复。
进一步说，所述的关节软骨下骨修复用支架，所述多孔盐层为多孔无机盐层或/和多孔有机盐层。
进一步说，所述的关节软骨下骨修复用支架，所述多孔无机盐层采用羟基磷灰石，或磷酸三钙，或透明质酸铵，或透明质酸四丁基铵制备，特别有利于与软骨层融合。
进一步说，所述的关节软骨下骨修复用支架，所述多孔有机盐层采用硫酸软骨素，或甘油磷酸，或果糖磷酸，或葡糖磷酸，或L-丝氨酸磷酸，或腺苷磷酸，或葡糖胺，或半乳糖胺，特别有利于与软骨层融合。
进一步说，所述的关节软骨下骨修复用支架，所述多孔金属材料层为多孔钽层，或多孔钛及其合金层，或多孔铌层，或多孔钴基合金层，或多孔不锈钢层，或多孔镍钛合金层，或多孔复合金属材料层。
进一步说，所述的关节软骨下骨修复用支架，所述多孔盐层的孔径为3μm -10μm，进一步说，所述的人工关节修复用材料，所述多孔盐层的孔径为3μm -10μm，该种结构的多孔盐层与其他多孔材料层复合的设置可以使关节软骨下骨修复用支架具有较好的渗流特性，一方面可使骨髓中的细胞、营养液等通过，同时一定程度上隔绝软骨与软骨下骨，使受力时关节腔的液体压力适度释放缓冲又不下降过多。
进一步说，所述的关节软骨下骨修复用支架，所述多孔金属材料层包括上下两层；其中，与所述多孔盐层相连接的多孔金属材料上层的孔径为50μm -100μm，多孔金属材料下层的孔径为100μm -1000μm，各层多孔金属材料内部及层之间的孔是相互贯通的。这种结构的材料用于人工关节修复时，其力的传递、吸收效果好，强度高，且其更便于骨组织长入，而且有利于骨细胞从多孔金属材料上层输出；或者使所述多孔金属材料层的孔径从与所述多孔盐层相邻的表面的孔径从50μm -100μm逐渐增大过渡到与所述多孔盐层背离的多孔金属材料层的远端表面的孔径达100μm -1000μm，多孔金属材料层内部的孔是相互贯通的，也具有上述两层多孔金属材料层的相当的效果。
进一步说，所述的关节软骨下骨修复用支架，所述梯度多孔金属材料层的梯度多孔金属材料为以最小梯度级的多孔金属材料为原材料制出孔径更大的孔所形成的多孔金属材料，构成梯度多孔金属材料的各梯度级多孔金属材料的孔是相互贯通的，这种结构的多孔金属材料不仅接近软骨下骨结构，还显著减小各级梯度间相接界面影响。更进一步说，所述梯度多孔金属材料层以贯通的3μm -10μm孔的多孔金属材料为原材料，制出两层更大孔径的材料，形成拥有上中下三层的梯度多孔金属材料层，其中，与所述多孔高分子材料层相邻的上层多孔金属材料层的孔径为3μm-10μm ，中间层多孔金属材料层的孔径为50μm-100μm，下层多孔金属材料层的孔径为100μm -1000μm，各层多孔金属材料内部及层之间的孔是相互贯通的，该种结构的人工关节修复用材料不仅力的传递、吸收效果更佳，其第一层、第二层起到皮质骨的作用，承受大的载荷，第三层起到松质骨作用，具有缓冲效果，而且具有较好的渗流特性，促进软骨下骨及软骨修复。
本发明提供的关节软骨下骨修复用支架，以仿生为手段，通过合理地设计多孔盐层、多孔金属材料层的结构，对关节软骨下骨结构进行仿生；梯度结构的多孔金属部分能承受复杂、大的载荷，并具有良好的缓冲功能，该种关节软骨下骨修复用支架实现了良好的力的传递，具有优良的力学性能，其强度高于多孔非金属材料，而多孔非金属材料常会强度不够或韧性不够，而且，该种关节软骨下骨修复用支架优于单一孔隙的高孔隙率多孔金属，单一孔隙的高孔隙率多孔金属材料刚性不足，在大载荷如冲击载荷作用下会变形过大造成坍塌等失效，多孔盐层又有利于与软骨层融合，同时，该种关节软骨下骨修复用支架具有良好的渗流特性，其孔径设计既有利于细胞、营养液迁移，又有助于维持关节内的液体具有适当的压力；该种关节软骨下骨修复用支架的孔径、材料设计又有助于软骨、骨细胞的寄居、分化、增值，因而它是真正的关节软骨下骨修复、再生材料。
附图说明
下面将结合附图与实施例对本发明作进一步阐述。
图1为本发明关节软骨下骨修复用支架结构示意图。
图2为实施例6中关节软骨下骨修复用支架结构示意图。
具体实施方式
下面结合附图对本发明的具体实施方式作说明，实施方式以本发明技术方案为前提，给出了详细的实施方式和具体的操作过程，但本发明的保护范围不仅限于下述的实施方式。
实施例1
参见图1，本实施例的关节软骨下骨修复用支架，自上而下依次由多孔盐层1和多孔金属材料层2构成。多孔盐层1为多孔无机盐层，采用多孔羟基磷灰石制备，其孔径为3μm-6μm，孔隙率为43%，厚度为0.5mm；多孔金属材料层1为多孔钛合金，材料为TC4，其中多孔钛合金具有两层，参见图1，其中与多孔盐层相连接的上层2-1的孔径为3μm-10μm，孔隙率为38%，厚度为2mm，下层2-2的孔径为100μm -450μm，孔隙率为82%，厚度为4mm，各层多孔钛合金内部及层之间的孔是相互贯通的。该人工关节修复用材料的制备方法如下：
（1）用钛合金TC4粉末与造孔剂混合压实烧结制备多孔钛合金上层。
（2）用泡沫浸浆法制备多孔钛合金下层。
（3）用真空扩散焊将多孔钛合金上层与多孔钛合金下层连接为一整体多孔钛合金。
（4）用真空冷冻干燥技术在整体多孔钛合金的多孔钛合金上层表面上制备多孔羟基磷灰石层，制完后即制得本实施例的关节软骨下骨修复用支架。
实施例2
本实施例的关节软骨下骨修复用支架与实施例1相似，不同之处为多孔金属材料层为多孔铌，上层的孔径为75μm-100μm，孔隙率为43%，下层的孔径为400μm -700μm，孔隙率为78%，各层多孔铌内部及层之间的孔是相互贯通的，多孔羟基磷灰石的孔径为5μm-10μm，孔隙率为36%，制备方法类似实施例1。
实施例3
本实施例的关节软骨下骨修复用支架与实施例1相似，不同之处为多孔金属材料层由镍钛合金制备，上层的孔径为50μm-80μm，孔隙率为39%，下层的孔径为700μm -1000μm，孔隙率为72%，各层多孔镍钛合金内部及层之间的孔是相互贯通的，多孔盐层采用透明质酸铵作为原材料制备，其孔径为4μm-8μm，孔隙率为38%，制备方法类似实施例1。
实施例4
本实施例的关节软骨下骨修复用支架的多孔盐层为多孔有机盐层，采用硫酸软骨素制备，其孔径为3μm-10μm，孔隙率为40%，厚度为0.6mm；多孔金属材料层采用多孔钛，该多孔钛为梯度多孔材料，其结构为：孔径从与所述多孔盐层相连接的表面的孔径为50μm -80μm逐渐增大过渡到与所述多孔盐层背离的多孔钛层的远端表面的孔径为100μm -500μm，厚度为4mm，多孔钛内部的孔是相互贯通的。其制备方法是：用计算机三维造型制备多孔钛模型，根据该模型用选择性激光烧结技术制备出多孔钛，制备硫酸软骨素溶液，将多孔钛孔径为50μm -80μm的表面浸入硫酸软骨素溶液深度0.3mm，冷冻干燥即制得具有多孔硫酸软骨素与多孔钛的组合体，即本实施例的关节软骨下骨修复用支架。
实施例5
本实施例的关节软骨下骨修复用支架与实施例4相似，不同之处为多孔金属材料层由不锈钢316L制备，其结构为：孔径从与所述多孔盐层相连接的表面的孔径为70μm-100μm逐渐增大过渡到与所述多孔盐层背离的多孔钛层的远端表面的孔径为500μm -1000μm，厚度为3.5mm，多孔盐层采用葡糖胺制备。关节软骨下骨修复用支架的制备方法类似实施例4。
实施例6
参见图2，本实施例的关节软骨下骨修复用支架，多孔盐1采用磷酸三钙制备，厚度为0.5mm。多孔金属材料层采用多孔CoCrMo合金，该多孔CoCrMo合金为上中下三层梯度多孔材料，与多孔盐层1相邻的上层多孔CoCrMo合金层3的孔径为3μm-10μm，厚度为0.8mm，中间层4的孔径为50μm-75μm，其孔的腔壁材料即为上述孔径为3μm -10μm的多孔CoCrMo合金，厚度为2mm，下层5的孔径为100μm-650μm，其腔壁材料即为上述孔径为3μm-10μm的多孔CoCrMo合金，厚度为4mm，各层多孔CoCrMo合金内部及层之间的孔是相互贯通的。制备方法如下：
（1）取粒径为30nm的CoCrMo合金粉，粒径为5μm-15μm的乙基纤维素粉，按照体积比CoCrMo合金粉：乙基纤维素粉为7：3混合，反复搅拌使其均匀混合，将混合粉放入硬质合金模具，施加10MPa压力压平，制备出上层多孔CoCrMo合金的生坯。
（2）取粒径为30nm的CoCrMo合金粉，粒径为5μm-15μm的乙基纤维素粉，粒径为65μm-85μm的尿素，按照体积比CoCrMo合金粉：乙基纤维素粉：尿素为7：3：25混合，反复搅拌使其均匀，放入含有上层多孔CoCrMo合金生坯的模具，施加10MPa压力压平，形成上层多孔CoCrMo合金与中间层多孔CoCrMo合金合成一体的生坯。
（3）取粒径30nm的CoCrMo合金粉，粒径为5μm-15μm的乙基纤维素粉，粒径为180μm-750μm的尿素，按照体积比CoCrMo合金粉：乙基纤维素粉：尿素为7：3：25混合，反复搅拌使其均匀，放入含有上层多孔CoCrMo合金与中间层多孔CoCrMo合金合成一体的生坯的模具，施加400MPa压力压实，保压27s，形成上层多孔CoCrMo合金、中间层多孔CoCrMo合金与下层多孔CoCrMo合金合成一体的生坯。
（4）将生坯放入真空炉中，进行真空烧结及热处理，即得到具有三层的梯度结构的多孔CoCrMo合金。
（5）用等离子喷涂在多孔CoCrMo合金上层表面上喷涂磷酸三钙，形成多孔磷酸三钙层，即制得本实施例的关节软骨下骨修复用支架。
实施例7
本实施例与实施例6相似，不同之处为多孔盐层采用透明质酸四丁基铵制备，多孔金属层采用钽制备，中间层4的孔径为70μm-100μm，下层5的孔径为600μm-1000μm，制备方法类似实施例6。
将实施例7的软骨下骨修复用材料制成植入体与绵羊自体骨膜复合后植入绵羊胫骨关节的软骨-软骨下骨缺陷处14周，通过组织学观察表明，骨组织长入多孔钽孔隙的94%，软骨缺损也基本得到修复。
Claims (10)
1.一种关节软骨下骨修复用支架，其特征在于：所述支架自上而下依次由多孔盐层和多孔金属材料层构成，所述多孔金属材料层为梯度多孔金属材料层。
2.如权利要求1所述的关节软骨下骨修复用支架，其特征在于：所述多孔盐层为多孔无机盐层或/和多孔有机盐层。
3.如权利要求2所述的关节软骨下骨修复用支架，其特征在于：所述多孔无机盐层采用羟基磷灰石或磷酸三钙或透明质酸铵或透明质酸四丁基铵制备而成。
4.如权利要求2所述的关节软骨下骨修复用支架，其特征在于：所述多孔有机盐层采用硫酸软骨素或甘油磷酸或果糖磷酸或葡糖磷酸或L-丝氨酸磷酸或腺苷磷酸或葡糖胺或半乳糖胺制备而成。
5.如权利要求1或2或3或4所述的关节软骨下骨修复用支架，其特征在于：所述多孔金属材料层为多孔钽层或多孔钛及其合金层或多孔铌层或多孔钴基合金层或多孔不锈钢层或多孔镍钛合金层或多孔复合金属材料层。
6.如权利要求1至5任一权利要求所述的关节软骨下骨修复用支架，其特征在于：所述多孔盐层的孔径为3μm -10μm。
7.如权利要求1至6任一权利要求所述的关节软骨下骨修复用支架，其特征在于：所述多孔金属材料层包括上下两层；其中，与所述多孔盐层相连接的多孔金属材料上层的孔径为50μm-100μm，多孔金属材料下层的孔径为100μm -1000μm，各层多孔金属材料内部及层之间的孔是相互贯通的。
8.如权利要求1至6任一权利要求所述的关节软骨下骨修复用支架，其特征在于：所述多孔金属材料层的孔径从与所述多孔盐层相连接的表面的孔径为50μm-100μm逐渐增大过渡到与所述多孔盐层背离的多孔金属材料层的远端表面的孔径为100μm -1000μm，多孔金属材料层内部的孔是相互贯通的。
9.如权利要求1至6任一权利要求所述的关节软骨下骨修复用支架，其特征在于：所述梯度多孔金属材料层的梯度多孔金属材料为以最小梯度级的多孔金属材料为原材料制出孔径更大的孔所形成的多孔金属材料，构成梯度多孔金属材料的各梯度级多孔金属材料的孔是相互贯通的。
10.如权利要求9所述的关节软骨下骨修复用支架，其特征在于：所述梯度多孔金属材料层以贯通的3μm -10μm孔的多孔金属材料为原材料，制出两层更大孔径的材料，形成拥有上中下三层的梯度多孔金属材料层，其中，与所述多孔盐层相邻的上层多孔金属材料层的孔径为3μm -10μm ，中间层多孔金属材料层的孔径为50μm-100μm，下层多孔金属材料层的孔径为100μm -1000μm，各层多孔金属材料内部及层之间的孔是相互贯通的。
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