CN106620850A - 骨科植入器材表面生物兼容性涂层及制备方法 - Google Patents

骨科植入器材表面生物兼容性涂层及制备方法 Download PDF

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CN106620850A
CN106620850A CN201710031176.7A CN201710031176A CN106620850A CN 106620850 A CN106620850 A CN 106620850A CN 201710031176 A CN201710031176 A CN 201710031176A CN 106620850 A CN106620850 A CN 106620850A
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implantation equipment
preparation
coating
orthopaedics implantation
hydroxyapatite
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焦敬
李乃义
隋宏
高峰
高齐辉
孙丰伟
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Abstract

本发明提供了骨科植入器材表面生物兼容性涂层的制备方法，包括如下步骤：(1)将金属待处理样品洗涤后，浸泡于配方溶液，取出干燥后金属样品的表面制得化学反应层和化学转换膜；(2)将步骤(1)处理后的金属样品洗涤后放置于羟基磷灰石悬浊液浸泡、干燥后表面制得羟基磷灰石涂层；所述金属待处理样品为金属基质的骨科植入器材。本发明以化学链接为主要结合方式的涂装方法可实现羟基磷灰石快速稳固的涂覆，从而完成生物兼容性涂层的制备。

Description

骨科植入器材表面生物兼容性涂层及制备方法
技术领域
本发明涉及金属表面涂层的制备，特别是涉及骨科植入器材金属表面高度生物兼容性涂层及其制备方法。
背景技术
目前，而手术器械、植入材料与其它医疗设备的主要材料为医用合金，生物兼容性较差。生物与医学需要对金属涂覆一种材料，其生物兼容性与自然牙齿或骨骼相近。羟基磷灰石(hydroxyapatite，简写为HA或HAP，分子式为Ca10(OH)2(PO4)6)是牙齿和骨骼的主要(无机)成分，在前沿医学上也作为人造骨的最佳成分。羟基磷灰石生物兼容性好，是能刺激或者诱导骨组织生长并能与骨组织形成骨性结合的天然陶瓷材料，生物兼容性及生物活性均优于磷酸三钙及其它磷钙陶瓷材料。羟基磷灰石的使用，有助于细胞的粘附、增殖及功能发挥，在直接作为骨、牙等替代或缺损修复材料的基础上，不但是优异的骨组织工程载体材料，也可作为其它医学功能材料或药物的载体材料。骨科植入器材类型较多，包括人工肱骨头，人工膝、肩、肘、踝、腕、掌指、掌趾、指间等关节，钉板系统及包含钢板、螺钉、锁钉等，钉棒系统及包含的钢板、螺钉、锁钉、横连接等，线缆系统及包含线缆、缆索接头等，矫形系统及包含螺钉(单向/万向)、连接棒、连接器等，融合系统(融合器)及包含钢板、螺钉、螺帽等部件。由于各种器材形状各异，大小不一，等离子真空喷涂或溅射等方法容易造成各项不均匀性，需要一种简便、经济的方法进行均匀涂覆，最好是溶液自生长方法。
发明内容
本发明的目的是解决现有骨科植入器材金属基底表面成膜技术中存在的部分问题，提供骨科植入器材表面生物兼容性涂层及其制备方法。
本发明的目的是通过以下技术方案实现的：
骨科植入器材表面生物兼容性涂层的制备方法，包括如下步骤：
(1)将金属待处理样品洗涤后，浸泡于配方溶液，取出干燥后金属样品的表面制得化学反应层和化学转换膜；
(2)将步骤(1)处理后的金属样品洗涤后放置于羟基磷灰石悬浊液浸泡、干燥、洗涤、干燥后表面制得羟基磷灰石涂层；
所述金属待处理样品为金属基质的骨科植入器材。
优选地，所述步骤(1)中浸泡温度为20-30℃，时间为30-60分钟。
优选地，所述步骤(1)中配方溶液为正磷酸、植酸、缓蚀剂、酒石酸钠、柠檬酸钠的混合液。
优选地，所述配方溶液中各成分的浓度为正磷酸3-5mol/l，植酸0.5-1mol/l，缓蚀剂0.6-3mol/l，酒石酸钠0.5-2g/l，柠檬酸钠0.5-2g/l。
优选地，所述配方溶液还包含磷酸二氢铁0.5-1g/l、氧化锌0.1-0.2g/l、磷酸钛0.5-1g/l、纳米氧化钛0.1-0.2g/l的任一种。
优选地，所述缓蚀剂为氨羟二磷酸、奥帕膦酸、唑来膦酸、利塞膦酸中的一种或多钟。
优选地，所述步骤(2)中的羟基磷灰石悬浊液的浓度为5-40g/l，羟基磷灰石颗粒大小为0.1-100微米；所述浸泡温度为20-30℃，时间为2-5分钟。
优选地，所述步骤(1)和步骤(2)中的干燥均为放置于燥箱中50-70℃干燥5-20分钟或20-30℃空气中干燥2-4小时。
本发明的另一方面，骨科植入器材表面生物兼容性涂层，由上述任一所述方法制备而得，依次包括金属基底、化学反应层、化学转换膜和羟基磷灰石涂层。
优选地，所述化学转换膜的厚度为0.1-10微米；羟基磷灰石涂层的厚度为1-100微米。
本发明的有益效果：
本发明提供的一种高效、简易的生物兼容性材料在骨科植入器材金属表面成膜方法，实现生物材料其与骨科植入器材金属基底的化学链接，提高骨科植入器材金属表面的生物兼容性能。本发明适用于各种尺寸、各类金属基底，如不锈钢，碳钢，螺纹钢，冷轧钢，热轧钢，锰钢，铝，铝合金，钛，钛合金，钴合金，镁铝合金等的一种。多数的金属医疗器械均是裸金属器械，本发明可有效改进生物兼容性问题，当本发明的转换化学层形成后，在骨科植入器材金属的表面可以吸附羟基磷灰石粉末成膜。这种以化学链接为主要结合方式的涂装方法可实现羟基磷灰石快速稳固的涂覆，从而完成骨科植入器材表面生物兼容性涂层的制备不同于物理或化学气相沉积等复杂昂贵的方法。
附图说明
图1是本发明产品的层结构示意图；
图2是实施例1产品的扫描电子显微镜检测示意图；
图3是实施例2产品的扫描电子显微镜检测示意图；
图4是实施例3产品的光电子能谱仪检测示意图。
具体实施方式
为了更好地说明本发明，下面结合本发明实施例中的附图，对本发明实施例中的技术方案进行清楚、完整地描述。
骨科植入器材表面生物兼容性涂层，包括金属基底12、金属表面13、化学反应层14、化学转换膜18和羟基磷灰石涂层16。所述化学转换膜的厚度为0.1-10微米；羟基磷灰石涂层的厚度为1-100微米。
制备方法如下：骨科植入器材的金属基底12与表面氧化物(如铁锈)等杂物或污染物，其中间分界为新鲜金属表面13；将骨科植入器材用去离子水超声洗涤后，根据需要选择去油、碱洗、抛喷丸等前处理工艺，放入常温浓度为正磷酸5mol/l，植酸1mol/l，缓蚀剂3mol/l，酒石酸钠0.5g/l，柠檬酸钠0.5g/l的配方溶液中，浸泡2分钟，利用溶液的酸性除去表面氧化物(铁锈)等杂物，可看到新鲜的金属表面13形成。继续浸泡30分钟，在缓蚀剂与其它配方的共同作用下，金属表面13上逐步形成一层以磷酸盐或膦酸盐为主的化学反应层14。这层盐的形成可参考引用文献，必要时可采用除氧装置。
将处理过的骨科植入器材取出在空气中干燥，化学反应层14上会形成一层化学转换膜18，多余的溶液可通过水流冲洗掉，剩余化学转换膜18厚度为10微米。
化学转换膜18形成后，将上述处理过的骨科植入器材在20℃下不断进行搅拌浸泡20g/l的羟基磷灰石(HA)悬浊液中放置5分钟，羟基磷灰石颗粒大小为50微米悬浊于水中的羟基磷灰石颗粒将在化学转换膜18的表面形成羟基磷灰石涂层16，厚度为1微米。
实施例1：
(1)将完成前处理的骨科植入器材表面的304不锈钢板用去离子水超声洗涤后，20℃浸泡于浓度为正磷酸5mol/l，植酸1mol/l，氨羟二磷酸3mol/l，酒石酸钠0.5g/l，柠檬酸钠0.5g/l、磷酸二氢铁0.5-1g/l的配方溶液中，浸泡30分钟，取出后放置于70℃干燥箱中干燥20分钟。
(2)将(1)步骤所得骨科植入器材用去离子水洗涤后，放置于5g/l的羟基磷灰石悬浊液中，不断进行搅拌20℃浸泡2分钟，羟基磷灰石颗粒大小为0.1微米；
(3)将(2)步骤所得骨科植入器材放置于干燥箱中60℃温度干燥15分钟；
(4)将(3)步骤所得骨科植入器材放置于去离子水中洗涤30秒；
(5)将(4)步骤所得骨科植入器材放置于30℃温度干燥2小时；
(6)将(5)步骤所得样品放置于扫描电子显微镜(SEM)中，放大500倍观察。
实施例2：
(1)将骨科植入器材表面的304不锈钢板用去离子水超声洗涤后，放置于20℃温度干燥4小时；
(2)将(1)步骤所得骨科植入器材用去离子水洗涤后，放置于40g/l的羟基磷灰石悬浊液中，不断进行搅拌30℃浸泡5分钟，羟基磷灰石颗粒大小为0.1微米；
(3)将(2)步骤所得骨科植入器材放置于干燥箱中65℃温度干燥18分钟；
(4)将(3)步骤所得骨科植入器材放置于去离子水中洗涤30秒；
(5)将(4)步骤所得骨科植入器材放置于干燥箱中35℃温度干燥3小时；
(6)将(5)步骤所得骨科植入器材放置于扫描电子显微镜(SEM)中，放大500倍观察。
实施例3：
(1)将骨科植入器材表面的304不锈钢板用去离子水超声洗涤后，30℃浸泡于浓度为正磷酸5mol/l，植酸1mol/l，缓蚀剂3mol/l，酒石酸钠0.5g/l，柠檬酸钠0.5g/l、氧化锌0.1-0.2g/l的配方溶液中，浸泡50分钟，放置于70℃干燥箱中干燥20分钟。
(2)将(1)步骤所得骨科植入器材用去离子水洗涤后，放置于30g/l的羟基磷灰石(HA)悬浊液中，不断进行搅拌25℃浸泡3分钟，羟基磷灰石颗粒大小为100微米；
(3)将(2)步骤所得骨科植入器材放置于干燥箱中65℃温度干燥20分钟；
(4)将(3)步骤所得骨科植入器材放置于去离子水中洗涤30秒；
(5)将(4)步骤所得骨科植入器材放置于干燥箱中30℃温度干燥3小时；取后放入光电子能谱仪(XPS)进行检测。
图2-3显示实施例1与实施例2产品的表面成膜情况。图2是形成化学转换膜的后的羟基磷灰石涂覆表面；图3是没有化学转换膜表面的羟基磷灰石涂覆表面。实施例1的骨科植入器材表面明显具有一层羟基磷灰石涂层，并有未冲洗掉的多余颗粒分布。实施例2骨科植入器材基本为钢材表面，几乎无羟基磷灰石涂层形成。上述实施例及附图有效的说明了在使用本发明的配方溶液后，金属表面形成的化学装换膜层可有效诱导羟基磷灰石涂层形成。
图4是实施例3的光电子能谱，结果表明使用了本发明完成化学转换膜后，金属表面涂覆了完整的羟基磷灰石涂层。
测试结果说明，本发明实施例1在使用了化学装换膜层后，可以有效吸附羟基磷灰石陶瓷粉体形成生物兼容性涂层；而不使用本发明的实施例2则无法进行涂覆。
以上所述，仅为本发明较佳的具体实施方式，但本发明的保护范围并不局限于此，任何熟悉本技术领域的技术人员在本发明披露的技术范围内，可轻易想到的变化或替换，都应该涵盖在本发明的保护范围之内。因此，本发明的保护范围应该以权利要求书的保护范围为准。

Claims (10)

1.骨科植入器材表面生物兼容性涂层的制备方法，其特征在于，包括如下步骤：
(1)将金属待处理样品洗涤后，浸泡于配方溶液，取出干燥后金属样品的表面制得化学反应层和化学转换膜；
(2)将步骤(1)处理后的金属样品洗涤后放置于羟基磷灰石悬浊液浸泡、干燥后表面制得羟基磷灰石涂层；
所述金属待处理样品为金属基质的骨科植入器材。
2.根据权利要求1所述的骨科植入器材表面生物兼容性涂层的制备方法，其特征在于，所述步骤(1)中浸泡温度为20-30℃，时间为30-60分钟。
3.根据权利要求1所述的骨科植入器材表面生物兼容性涂层的制备方法，其特征在于，所述步骤(1)中配方溶液为正磷酸、植酸、缓蚀剂、酒石酸钠、柠檬酸钠的混合液。
4.根据权利要求3所述的骨科植入器材表面生物兼容性涂层的制备方法，其特征在于，所述配方溶液中各成分的浓度为正磷酸3-5mo l/l，植酸0.5-1mol/l，缓蚀剂0.6-3mol/l，酒石酸钠0.5-2g/l，柠檬酸钠0.5-2g/l。
5.根据权利要求4所述的骨科植入器材表面生物兼容性涂层的制备方法，其特征在于，所述配方溶液还包含磷酸二氢铁0.5-1g/l、氧化锌0.1-0.2g/l、磷酸钛0.5-1g/l、纳米氧化钛0.1-0.2g/l的任一种。
6.根据权利要求4所述的骨科植入器材表面生物兼容性涂层的制备方法，其特征在于，所述缓蚀剂为氨羟二磷酸、奥帕膦酸、唑来膦酸、利塞膦酸中的一种或多钟。
7.根据权利要求1所述的骨科植入器材表面生物兼容性涂层的制备方法，其特征在于，所述步骤(2)中的羟基磷灰石悬浊液的浓度为5-40g/l，羟基磷灰石颗粒大小为0.1-100微米；所述浸泡温度为20-30℃，时间为2-5分钟。
8.根据权利要求1所述的骨科植入器材表面生物兼容性涂层的制备方法，其特征在于，所述步骤(1)和步骤(2)中的干燥均为放置于燥箱中50-70℃干燥5-20分钟或20-30℃空气中干燥2-4小时。
9.根据权利要求1-8任一所述的方法制备的骨科植入器材表面生物兼容性涂层，其特征在于，依次包括金属基底、化学反应层、化学转换膜和羟基磷灰石涂层。
10.根据权利要求9所述的骨科植入器材表面生物兼容性涂层，其特征在于，所述化学转换膜的厚度为0.1-10微米；羟基磷灰石涂层的厚度为1-100微米。
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CN107441554A (zh) * 2017-09-25 2017-12-08 四川大学 具有植酸‑金属离子‑羟基磷灰石涂层的骨修复材料及其制备方法
CN111996521A (zh) * 2020-08-26 2020-11-27 西南交通大学 一种在生物可降解锌表面构建无机微米花嵌合金属-有机复合纳米簇改性功能层的方法
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CN107441554A (zh) * 2017-09-25 2017-12-08 四川大学 具有植酸‑金属离子‑羟基磷灰石涂层的骨修复材料及其制备方法
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CN115591011A (zh) * 2022-09-22 2023-01-13 北京大学深圳医院（Cn） 一种可降解锌金属表面动态功能性涂层及其制备方法
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