CN114191606B - 一种3d打印骨整合假肢材料及假肢及其表面处理方法 - Google Patents

一种3d打印骨整合假肢材料及假肢及其表面处理方法 Download PDF

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CN114191606B
CN114191606B CN202111446295.1A CN202111446295A CN114191606B CN 114191606 B CN114191606 B CN 114191606B CN 202111446295 A CN202111446295 A CN 202111446295A CN 114191606 B CN114191606 B CN 114191606B
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osseointegrated
surface treatment
printing
prosthesis
porous
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CN114191606A (zh
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许猛
石岩
姬涛
赵雪林
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Fourth Medical Center General Hospital of Chinese PLA
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Fourth Medical Center General Hospital of Chinese PLA
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Abstract

本发明公开了一种3D打印多孔骨整合假肢材料及假肢，所述假肢由Al‑Mg合金通过3D打印的方法得到，为了提高整合效果、缩短整合周期、降低感染率，对多孔骨整合假肢进行表面处理，包括采用高速喷丸法喷涂微小钽金属颗粒和羟基磷灰石和电解抛光处理，使得多孔骨整合假肢材料具有抗感染、易于整合的特点，并降低其成本。

Description

一种3D打印骨整合假肢材料及假肢及其表面处理方法
技术领域
本发明涉及医疗器械技术领域，更具体的说是涉及一种3D打印骨整合假肢材料及假肢及其表面处理方法。
背景技术
到2020年底，全球230个国家总人口已达到76亿，且随着人口老龄化进程的不断加快，创伤性疾病的不断增加，全球每年因工伤、疾病、交通意外、战争等因素而造成大量人员上肢、下肢截肢以保全生命，但其运动行走能力残缺，严重影响患者的工作与生活，给其心理、家庭及社会带来极大负担，为融入正常的生活、生产中，截肢患者通常需要佩戴假肢实现行走运动功能的重建。传统的假肢是在截肢残端外使用接受腔与假肢连接的壳式假肢。这种假肢的由于接受腔不能平均分配承重，难以符合生物力学要求，并且常常由于局部受力不均和摩擦造成皮肤炎症甚至破溃。此外由于接受腔密闭，常常造成局部出汗，恶臭，严重影响患者的生活质量。壳式假肢的一系列弊端呼吁临床和科研工作者尽快提出更加符合生物力学的使用便捷的假肢设计。20世纪50年代，瑞典Branemark教授发现将钛金属置入兔股骨内一定时间后难以取出，骨和金属实现了良好的锚定，他将这种结合定义为假体与骨整合：即种植体与具有活性的骨组织产生持久性的骨性接触。植入式骨整合假肢取消了传统假肢接受腔,借鉴种植牙的技术,一端插入残端骨内腔,另一端经皮肤伸出体外与假肢联接.这种残肢从根本上解决了传统假肢因接受腔-残肢界面透气性差,产生恶臭,因磨擦引起的残肢感染等问题。
外科手术中常采用人工植入物，以替换患者失效部位。临床上常金属材料作为植入部分，其包括钛合金、不锈钢以及钴铬合金等，主要作为人工关节、骨代替物等，替换患者受损或病变的硬质组织。不锈钢是发展较早，材料成本较低的金属医用植入材料，曾占据了较大部分的医用金属植入物市场。但由于不锈钢的密度较大，患者异物感强，且Fe的耐蚀性较差，使用过程中磨损释放的Ni、Cr离子对细胞毒副作用大等因素，其在植入体市场上的应用规模在不断缩小。随着生物医用合金的更新发展，具有更好生物相容性的钛及钛合金产品近年来被广泛的应用于骨组织修复上。但钛及其合金产品的弹性模量与人体骨骼相差较大，从而会导致所谓的“应力屏蔽”效应发生，长期将会导致植入体周围骨吸收，甚至导致植入体的滑落，降低骨植入的成功率。
针对现有骨整合假肢材料弹性模量大、整合周期长、成本高等问题，构建一种3D打印多孔骨整合假肢材料及假肢，为了提高整合效果、缩短整合周期、降低感染率，对多孔骨整合假肢进行表面处理，包括采用高速喷丸法喷涂微小钽金属颗粒和羟基磷灰石和电解抛光处理，使得多孔骨整合假肢材料具有抗感染、易于整合的特点，并降低其成本。
发明内容
有鉴于此，本发明提供了一种3D打印多孔骨整合假肢材料及假肢以及假肢的表面处理方法，本发明采用Al-Mg合金作为假肢材料，熔点低从而可以降低3D打印温度，提高打印速度和固化速度，进而提高生产率。
为了达到上述目的，本发明采用如下技术方案：
一种3D打印多孔骨整合假肢材料，所述骨整合假肢材料为Al-Mg合金。
优选的，所述Al-Mg合金中，Al与Mg的质量比为(1:5)～(5:1)。
上述优选带来的有益效果为：人体皮质骨的弹性模量为10～30GPa，实体Al-Mg合金的弹性模量约为40GPa，二者相差不大，从而防止“应力屏蔽”效应发生，增加整合的牢固程度，防止假肢松脱。
本发明的另一个目的在于提供一种3D打印多孔骨整合假肢，所述骨整合假肢由上述骨整合假肢材料通过3D打印方式制得，3D打印过程中采用氩气作为保护气体，温度设定为650～750℃，打印速度设定为20～200mm/s。
优选的，所述骨整合假肢的孔隙率为20～80％。
骨整合假肢的孔隙率为20～80％时，其弹性模量与人骨相差不大，可防止“应力屏蔽”效应发生，增加整合的牢固程度，另外可使骨组织长入到孔隙中，达到更好的整合效果。
本发明还有一个目的在于提供上述的一种3D打印多孔骨整合假肢的表面处理方法，包括以下步骤：
(1)高速喷丸处理
将所述骨整合假肢进行超声清洗、干燥，然后进行喷丸处理；喷丸后在显微镜下观察喷涂层，使涂层致密，达到抗菌和隔绝Al-Mg金属层的效果；
(2)电解抛光处理
针对喷丸处理后表面粗糙的骨整合假肢进行电解抛光处理。
优选的，所述超声清洗中的清洗剂为无水乙醇，超声频率为10～50Khz，处理时间为0.5～2h，超声清洗之后，烘干箱干燥处理5～10min。
优选的，所述喷丸处理包括，将质量比为(1:3)～(3:1)的钽粉和羟基磷灰石球磨成50～200μm的颗粒，然后对骨整合假肢的所有表面进行喷丸，喷涂层的厚度为200～500μm。
优选的，所述电解抛光处理中，电解液为体积分数为4％的HNO3溶液，电解液温度为20～30℃，直流电3～15V，抛光时间为15～20min。
经由上述的技术方案可知，与现有技术相比，本发明具有如下有益效果：
1.将Al-Mg合金材料采用3D打印的方式制备多孔骨整合假肢可在一定程度上节约成本，并且Al-Mg合金的弹性模量与人体骨骼相差不大可很好地避免应力屏蔽效应使假肢与人骨组织结合度更高，也可避免整合后的脱离现象。
2.Al-Mg合金的熔点较低，3D打印温度设定低，打印速度和固化速度都可提高，从而可使生产效率提高。
3.对3D打印出的多孔骨整合假肢进行表面喷丸处理和电解抛光处理一方面可隔绝Al-Mg合金与骨组织的接触，另一方面钽颗粒、羟基磷灰石都具有很好的生物学性能，可抗感染，喷丸处理和电解抛光后可提高多孔假肢表面的光洁度可进一步降低感染率。
附图说明
为了更清楚地说明本发明实施例或现有技术中的技术方案，下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本发明的实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据提供的附图获得其他的附图。
图1为本发明方法流程图。
具体实施方式
下面将对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。
实施例1
一种3D打印骨整合假肢，通过以下方法制得:
选择质量比为(2:5)的Al粉与Mg粉，将Al粉与Mg粉混合球磨至粒径约为200μm，放入3D打印机的送粉器中，将温度设定为680℃，打印速度设定为40mm/s，进行3D打印，整个打印过程采用氩气保护，最终制备出了者直径为8mm孔隙率为50％的骨整合假肢。
为使骨整合假肢表面更加光滑，将制备的骨整合假肢进行电解抛光处理，电解液为体积分数为4％的HNO3溶液，电解液温度为20℃,电解电压为5V的直流电,抛光时间为15min。
电解抛光处理后采用无水乙醇将骨整合假肢进行清洗，超声频率为10Khz,处理时间为0.5h，超声清洗之后，放入烘干箱，干燥处理10min。对骨整合假肢进行表面质量检测，如无气孔，表面开裂和缺陷即为合格品，然后在万能试验机上对骨整合假肢进行拉伸和压缩力学性能检测，拉伸和压缩速率均设定为1mm/min，实验测得假肢的弹性模量为38.4GPa,与人骨弹性模量接近，说明制备成功。
实施例2
选择质量比为(1:5)的Al粉与Mg粉，将Al粉与Mg粉混合球磨至粒径约为200μm，放入3D打印机的送粉器中，将温度设定为650℃，打印速度设定为20mm/s，进行3D打印，整个打印过程采用氩气保护，最终制备出了者直径为8mm孔隙率为20％的骨整合假肢。
对假肢表面进行高速喷丸处理，喷丸粒子选择球磨后的羟基磷灰石颗粒，粒径为80μm，喷丸层厚度100μm。为使骨整合假肢表面更加光滑，将制备的骨整合假肢进行电解抛光处理，电解液为体积分数为4％的HNO3溶液，电解液温度为20℃,电解电压为5V的直流电,抛光时间为15min。
电解抛光处理后采用无水乙醇将骨整合假肢进行清洗，超声频率为10Khz,处理时间为0.5h，超声清洗之后，放入烘干箱，干燥处理10min。对骨整合假肢进行表面质量检测，如无气孔，表面开裂和缺陷即为合格品，然后在万能试验机上对骨整合假肢进行拉伸和压缩力学性能检测，拉伸和压缩速率均设定为1mm/min，实验测得假肢的弹性模量为38.4GPa,与人骨弹性模量接近，说明制备成功。
实施例3
选择质量比为(5:1)的Al粉与Mg粉，将Al粉与Mg粉混合球磨至粒径约为200μm，放入3D打印机的送粉器中，将温度设定为680℃，打印速度设定为200mm/s，进行3D打印，整个打印过程采用氩气保护，最终制备出了者直径为8mm孔隙率为80％的骨整合假肢。
对假肢表面进行高速喷丸处理，喷丸粒子选择球磨后的钽颗粒，粒径为100μm，喷丸层厚度为50μm。为使骨整合假肢表面更加光滑，将制备的骨整合假肢进行电解抛光处理，电解液为体积分数为4％的HNO3溶液，电解液温度为30℃,电解电压为15V的直流电,抛光时间为20min。
电解抛光处理后采用无水乙醇将骨整合假肢进行清洗，超声频率为50Khz,处理时间为2h，超声清洗之后，放入烘干箱，干燥处理10min。对骨整合假肢进行表面质量检测，如无气孔，表面开裂和缺陷即为合格品，然后在万能试验机上对骨整合假肢进行拉伸和压缩力学性能检测，拉伸和压缩速率均设定为1mm/min，实验测得假肢的弹性模量为38.4GPa,与人骨弹性模量接近，说明制备成功。
本说明书中各个实施例采用递进的方式描述，每个实施例重点说明的都是与其他实施例的不同之处，各个实施例之间相同相似部分互相参见即可。对于实施例公开的装置而言，由于其与实施例公开的方法相对应，所以描述的比较简单，相关之处参见方法部分说明即可。
对所公开的实施例的上述说明，使本领域专业技术人员能够实现或使用本发明。对这些实施例的多种修改对本领域的专业技术人员来说将是显而易见的，本文中所定义的一般原理可以在不脱离本发明的精神或范围的情况下，在其它实施例中实现。因此，本发明将不会被限制于本文所示的这些实施例，而是要符合与本文所公开的原理和新颖特点相一致的最宽的范围。

Claims (6)

1.一种3D打印多孔骨整合假肢，其特征在于，所述骨整合假肢的材料为Al-Mg合金；
其中，所述Al-Mg合金由Al粉与Mg粉混合得到；
所述Al-Mg合金中，Al与Mg的质量比为（1:5）~（5:1）；
所述骨整合假肢的孔隙率为20~80%。
2.如权利要求1所述的一种3D打印多孔骨整合假肢的制备方法，其特征在于，3D打印过程中采用氩气作为保护气体，温度设定为650~750℃，打印速度设定为20~200mm/s。
3.如权利要求1所述的一种3D打印多孔骨整合假肢的表面处理方法，其特征在于，包括以下步骤：
（1）表面处理
将权利要求2所述制备方法制得的骨整合假肢进行超声清洗、干燥，然后进行表面处理；
（2）电解抛光处理
针对表面处理后表面粗糙的骨整合假肢进行电解抛光处理。
4.根据权利要求3所述的一种3D打印多孔骨整合假肢的表面处理方法，其特征在于，所述超声清洗中的清洗剂为无水乙醇，超声频率为10~50Khz，处理时间为0.5~2h，超声清洗之后，烘干箱干燥处理5~10min。
5.根据权利要求3所述的一种3D打印多孔骨整合假肢的表面处理方法，其特征在于，所述表面处理包括，将质量比为（1:3）~（3:1）的钽粉和羟基磷灰石球磨成50~200μm的颗粒，然后对骨整合假肢的所有表面进行喷涂，喷涂层的厚度为200~500μm。
6.根据权利要求3所述的一种3D打印多孔骨整合假肢的表面处理方法，其特征在于，所述电解抛光处理中，电解液为体积分数为4%的HNO3溶液，电解液温度为20~30℃，直流电3~15V，抛光时间为15~20min。
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