CN112603603A - 一种兼具有抗菌和促骨作用的个性化假体及其制造方法 - Google Patents
一种兼具有抗菌和促骨作用的个性化假体及其制造方法 Download PDFInfo
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Abstract
本发明公开了一种兼具有抗菌和促骨作用的个性化假体及其制造方法，该个性化假体包括主要承受作用力的基体部分以及位于基体部分上与人体残余骨骼贴合连接的接触面部分，基体部分为实体，接触面部分是一层具有规律性的多孔结构或者具有随机性的轻量化结构。个性化假体表面涂覆有含有Li+、Zn2+、Cu2+的生物陶瓷浆料，Zn2+和Cu2+能够起到杀菌和抗菌的作用，Li+和生物陶瓷能够促进细胞的增殖分化，进而促进人体残余骨骼与个性化假体连接的可靠性和安全性，特别适用于感染性骨缺损的修复。本发明制造的个性化假体不仅具有良好的力学性能，还可以在前期抗菌抑制感染，后期持续促进人体残余骨骼与个性化假体的整合。
Description
技术领域
本发明属于个性化假体制造技术领域，具体涉及一种兼具有抗菌和促骨作用的个性化假体及其制造方法。
背景技术
感染性骨病的治疗是骨科临床的一大难题，感染性骨缺损病灶局部存在炎症刺激，导致局部成骨细胞不足，骨再生能力低下等诸多不利于成骨的微环境因素，人体残余骨骼难以与个性化假体植入物很好地实现骨整合，致使后期容易出现假体松动的现象。由于感染部位特殊的骨缺损，其病情复杂、病程漫长，临床上具有感染复发率高，难以治愈的特点。此类疾病给患者带来沉重的经济负担，大大降低了患者的生活质量，同时耗费了大量的医疗和公共资源。
目前临床上多采用病灶清除辅以植骨、抗生素治疗为主。但自体骨移植治疗骨缺损存在破坏供区，导致二次损伤等缺点，同时自体骨来源有限难以用于较大骨缺损的治疗；此外，同种异体骨也存在传播疾病、排斥反应等缺点。目前常规应用抗生素治疗存在作用时效短暂，病灶局部血药浓度低，同时频繁注射给药费用高，病人顺应性差，加重患者身体、心理及经济负担等弊端，若局部应用高浓度抗生素则会抑制成骨细胞、内皮细胞生长进而影响骨折愈合。因此，针对病灶局部病理特点，如何更安全有效地治愈及修复感染性骨缺损是目前骨科面临的巨大挑战和研究热点。
近年来国内大量研究基本聚焦在局部负载抗生素骨修复材料缓释系统的研制，一系列研究证实，同种异体骨复合庆大霉素，负载妥布霉素的硫酸钙小球与脱矿骨基质复合，载药的自凝固磷酸钙骨水泥组合异种骨，明胶组合异种脱蛋白骨复合抗生素植骨材料以及载药纳米羟基磷灰石复合胶原材料等在体内可吸收且具有一定的抗感染及骨传导作用。但载药修复支架仍存在滥用抗生素从而对机体带来不良反应，及细菌产生耐药性等风险。因此，本发明所制造的个性化假体具有抗菌和促骨双重作用，可以适应任意形状，任意位置的骨缺损；涂覆烧结后的个性化假体表面的Zn2+与Cu2+金属离子在前期能够快速释放起到杀菌和抗菌的作用，并避免了抗生素的耐药性的问题；Li+和生物陶瓷能够缓慢的释放促进细胞的增殖和分化，进而促进骨缺损的快速修复以及个性化假体的置换。
发明内容
本发明的目的是，针对目前感染性骨缺损修复中存在病情复杂、病程漫长、临床上具有感染复发率高、难以治愈等问题，为了促进感染性骨缺损的快速修复，提出的一种兼具有抗菌和促骨作用的个性化假体及其制造方法，在个性化假体表面涂覆含有Li+、Zn2+、Cu2+的生物陶瓷浆料，Zn2+和Cu2+能够起到杀菌和抗菌的作用，Li+和生物陶瓷能够促进细胞的增殖分化，进而促进人体残余骨骼与个性化假体连接的可靠性和安全性，特别适用于感染性骨缺损的个性化修复。
本发明采用如下技术方案来实现的：
一种兼具有抗菌和促骨作用的个性化假体，该个性化假体包括主要承受作用力的基体以及位于基体上与人体残余骨骼贴合连接的接触面；其中，
接触面上设计成一层具有规律性的多孔结构或者具有随机性的轻量化结构，以形成一层厚度为0.5-3mm，孔隙率为5%-30%，孔隙大小为0.5-3mm的多孔结构，并深入至基体内，且基体和接触面为同一假体的两部分，制造时一体成型；
该个性化假体表面涂覆有含有Li+、Zn2+、Cu2+的生物陶瓷浆料，Zn2+和Cu2+能够起到杀菌和抗菌的作用，Li1+和生物陶瓷能够促进细胞的增殖分化，进而促进人体残余骨骼与个性化假体连接的可靠性和安全性，特别适用于感染性骨缺损的修复。
本发明的进一步改进在于，该个性化假体的接触面上的规律性多孔结构或者随机性轻量化结构的孔隙率和孔隙大小可以根据假体的受力状况及假体尺寸大小通过结构设计来进行调整。
一种兼具有抗菌和促骨作用的个性化假体的制造方法，包括以下步骤：
1）个性化假体的设计及打印文件的准备
将患者的CT数据重建成三维模型，基于该三维模型，根据医生的手术方案设计出满足要求的个性化假体初始实体模型。根据假体的受力情况及安装要求确定多孔结构层厚度、孔隙大小及孔隙率。最后，将设计好的最终假体模型进行分层切片处理。
2）个性化假体制造
根据实际应用需求，将处理好的切片文件导入不同类型的3D打印机中进行直接打印成型，进行去支撑、打磨、热处理等后处理操作；或者先制造出个性化假体的模具，进而通过注塑或者铸造的方式得到个性化假体。
3）具有抗菌和促骨作用的浆料的制备
将含有Li、Zn和Cu元素的化合物粉末与生物陶瓷粉末进行混合，以蒸馏水作为溶剂，制备成具有一定浓度的混合浆料。
4）浆料涂覆烧结
将步骤2）中制造出的个性化假体放入步骤3）制得的混合浆料中，待涂覆稳定后放入烧结炉中进行烧结。烧结温度为200-250℃，烧结时间为5-30min，得到最终的兼具有抗菌和促骨作用的个性化假体。
本发明的进一步改进在于，步骤2）中个性化假体是通过3D打印技术直接制造成型或者利用3D打印技术间接成型。其中，直接成型方法为材料挤出工艺制造个性化聚醚醚酮及其复合材料假体或者粉末床熔融工艺制造个性化钛合金假体；间接成型方法为利用3D打印技术制造模具，通过注塑技术制造个性化聚醚醚酮及其复合材料假体或者通过铸造技术制造个性化钛合金假体。
本发明的进一步改进在于，步骤3）中所述的含Li元素的化合物为LiCl，含Zn元素的化合物为ZnCl2或ZnSO4，含Cu元素的化合物为CuCl2或CuSO4，所述的生物陶瓷为羟基磷灰石、磷酸三钙、硅酸钙、氧化锆和二氧化钛中的一种或者几种的组合。
本发明的进一步改进在于，步骤3）所述的浆料溶液中Zn2+与Cu2+的摩尔比为1:10-10:1，Li+与生物陶瓷的摩尔比为1:10-10:1，Zn2+和Cu2+的总含量与Li+和生物陶瓷总含量的摩尔比为1:2-2:1，混合浆料的质量浓度为10%-40%。
本发明具有如下有益的技术效果：
1.该个性化假体的制造过程可以只用到材料挤出工艺3D打印机或者粉末床熔融工艺3D打印机设备即可实现任意部位的个性化需求，因此，制造工艺简单，降低了设备以及人力物力费用，进而降低了制造成本的20%-30%；
2.个性化假体的性能可控，可以根据实际应用需求，在三个方面进行选择：1）在假体设计时对接触面（2）部分的多孔结构进行孔隙大小和孔隙率的调整；2）在打印个性化假体时可以选择不同的材料；3）可以选择直接打印成型或者间接注塑、铸造成型，后者具有更加优异的综合力学性能；
3.Zn2+和Cu2+能够有效地起到杀菌和抗菌的作用，解决了临床上抗生素产生的耐药性的问题，Li+和生物陶瓷能够快速地促进细胞的增殖分化，进而促进人体残余骨骼与个性化假体连接的可靠性和安全性，而且其成本较低；
4.个性化假体包含基体部分和接触面部分，接触面部分由于直接与人体残余骨骼连接配合，因此设计的多孔结构，一方面能够增加接触面部分附近Li+、Zn2+、Cu2+以及生物陶瓷的含量，从而更好地促进该连接部位炎症消退后的细胞增殖分化，另一方面多孔结构能够为骨生长提供更大的空间，长入多孔结构中的骨骼能够进一步加强个性化假体与人体残余骨骼连接的可靠性与安全性；
5.个性化假体包含基体部分和接触面部分，基体部分由于与软组织及关节窝配合，因此外表较光滑，避免了损伤软组织，接触面部分由于考虑到上述优点4的情况，设计成多孔结构。因此该设计具有较好的结构合理性与实用性；
6.烧结工艺能够保证Li+、Zn2+、Cu2+以及生物陶瓷与个性化假体具有较高的粘附力。
附图说明
图1为本发明的具有实体基体部分和多孔结构连接面部分的个性化假体；
图2为本发明的工艺流程图。
具体实施方式
以下结合附图和实施例对本发明做出进一步的说明。
实施例1
如图1所示，一种兼具有抗菌和促骨作用的个性化假体，该个性化假体包括主要承受作用力的基体1以及位于基体上与人体残余骨骼贴合连接的接触面2；其中，接触面2上设计成一层具有规律性的多孔结构或者具有随机性的轻量化结构，以形成一层厚度为0.5-3mm，孔隙率为5%-30%，孔隙大小为0.5-3mm的多孔结构，并深入至基体内，且基体和接触面为同一假体的两部分，制造时一体成型。
该个性化假体的接触面2上的规律性多孔结构或者随机性轻量化结构的孔隙率和孔隙大小可以根据假体的受力状况及假体尺寸大小通过结构设计来进行调整。
该个性化假体表面涂覆有含有Li1+、Zn2+、Cu2+的生物陶瓷浆料，Zn2+和Cu2+能够起到杀菌和抗菌的作用，Li+和生物陶瓷能够促进细胞的增殖分化，进而促进人体残余骨骼与个性化假体连接的可靠性和安全性，特别适用于感染性骨缺损的修复。
实施例2
本实施例的兼具有抗菌和促骨作用的个性化假体的制造方法如下：
（1）将患者的CT数据导入mimics软件中重建成三维模型，基于该三维模型，根据医生的手术方案，在3-matic软件中设计出满足要求的个性化假体初始实体模型。根据假体的受力情况及安装要求确定多孔结构层厚度为3mm、孔隙大小为3mm及孔隙率为30%。将设计完成后的具有实体部分和多孔结构部分的个性化假体导入Jugao AM切片软件中以0.1mm的层厚进行切片，填充方案选择同心圆填充，添加支撑结构。将切片文件导入陕西聚高聚醚醚酮3D打印机中进行打印，对打印完成的零件进行去支撑，打磨，热处理等后处理工艺，得到个性化聚醚醚酮假体。
（2）将含有Li、Zn和Cu元素的化合物粉末与生物陶瓷粉末进行混合，制备成质量浓度为40%的混合浆料，浆料中Zn2+与Cu2+的摩尔比为1:10，Li+与生物陶瓷的摩尔比为1:10，Zn2+和Cu2+的总含量与Li+1和生物陶瓷总含量的摩尔比为1:2；将制造出的个性化假体放入制得的混合浆料中，待涂覆稳定后放入烧结炉中进行烧结。烧结温度为200℃，烧结时间为5min，得到最终的兼具有抗菌和促骨作用的个性化聚醚醚酮假体。
实施例3
本实施例的兼具有抗菌和促骨作用的个性化假体的制造方法如下：
（1）将患者的CT数据导入mimics软件中重建成三维模型，基于该三维模型，根据医生的手术方案，在3-matic软件中设计出满足要求的个性化假体初始实体模型。根据假体的受力情况及安装要求确定多孔结构层厚度为0.5mm、孔隙大小为0.5mm及孔隙率为5%。将设计完成后的具有实体部分和多孔结构部分的个性化假体导入Renishaw Quant AM切片软件中以0.03mm的层厚进行切片，添加支撑结构。将切片文件导入英国雷尼绍RenAM500型号3D打印机中进行打印，对打印完成的零件进行去支撑，打磨，热处理等后处理工艺，得到个性化钛合金假体。
（2）将含有Li、Zn和Cu元素的化合物粉末与生物陶瓷粉末进行混合，制备成质量浓度为10%的混合浆料。浆料中Zn2+与Cu2+的摩尔比为10:1，Li+与生物陶瓷的摩尔比为10:1，Zn2+和Cu2+的总含量与Li+和生物陶瓷总含量的摩尔比为2:1。将制造出的个性化假体放入制得的混合浆料中，待涂覆稳定后放入烧结炉中进行烧结。烧结温度为250℃，烧结时间为30min，得到最终的兼具有抗菌和促骨作用的个性化钛合金假体。
显然，以上所描述的实施例仅仅是本发明两种实施例，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作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。
Claims (6)
1.一种兼具有抗菌和促骨作用的个性化假体，其特征在于：该个性化假体包括承受作用力的基体（1）以及位于基体（1）上与人体残余骨骼贴合连接的接触面（2）；其中，
接触面（2）上设计成一层具有规律性的多孔结构或者具有随机性的轻量化结构，以形成一层厚度为0.5-3mm，孔隙率为5%-30%，孔隙大小为0.5-3mm的多孔结构，并深入至基体（1）内，且基体（1）和接触面（2）为同一假体的两部分，制造时一体成型；
该个性化假体表面涂覆有含有Li+、Zn2+、Cu2+的生物陶瓷浆料。
2.根据权利要求1所述的兼具有抗菌和促骨作用的个性化假体，其特征在于：所述接触面（2）上规律性的多孔结构或者随机性的轻量化结构的孔隙率和孔隙大小可以根据假体的受力状况及假体尺寸大小通过结构设计来进行调整。
3.根据权利要求1或2所述的兼具有抗菌和促骨作用的个性化假体的制造方法，其特征在于，包括以下步骤：
1）个性化假体的设计及打印文件的准备：将患者的CT数据重建成三维模型，基于该三维模型，根据医生的手术方案设计出满足要求的个性化假体初始实体模型，根据假体的受力情况及安装要求确定多孔结构层厚度、孔隙大小及孔隙率，最后，将设计好的最终假体模型进行分层切片处理；
2）个性化假体制造：根据实际应用需求，将处理好的切片文件导入不同类型的3D打印机中进行直接打印成型，进行去支撑、打磨、热处理操作；或者先制造出个性化假体的模具，进而通过注塑或者铸造的方式得到个性化假体；
3）具有抗菌和促骨作用的浆料的制备：将含有Li、Zn和Cu元素的化合物粉末、生物陶瓷粉末以蒸馏水为溶剂进行混合，制备成具有一定浓度的混合浆料；
4）浆料涂覆烧结：将步骤2）中制造出的个性化假体放入步骤3）制得的混合浆料中，待涂覆稳定后放入烧结炉中进行烧结，烧结温度为200-250℃，烧结时间为5-30min，得到兼具有抗菌和促骨作用的个性化假体。
4.根据权利要求3所述的兼具有抗菌和促骨作用的个性化假体的制造方法，其特征在于，该个性化假体是通过3D打印技术直接制造成型或者利用3D打印技术间接成型；其中，直接成型方法为材料挤出工艺制造个性化聚醚醚酮及其复合材料假体或者粉末床熔融工艺制造个性化钛合金假体；间接成型方法为利用3D打印技术制造模具，通过注塑技术制造个性化聚醚醚酮及其复合材料假体或者通过铸造技术制造个性化钛合金假体。
5.根据权利要求3所述的兼具有抗菌和促骨作用的个性化假体的制造方法，其特征在于，所述的含Li元素的化合物为LiCl，含Zn元素的化合物为ZnCl2或ZnSO4，含Cu元素的化合物为CuCl2或CuSO4，所述的生物陶瓷为羟基磷灰石、磷酸三钙、硅酸钙、氧化锆或二氧化钛中的一种或者几种的组合。
6.根据权利要求5中所述的兼具有抗菌和促骨作用的个性化假体的制造方法，其特征在于，混合浆料中Zn2+与Cu2+的摩尔比为1:10-10:1，Li+与生物陶瓷的摩尔比为1:10-10:1，Zn2+和Cu2+的总含量与Li1+和生物陶瓷总含量的摩尔比为1:2-2:1，混合浆料的质量浓度为10%-40%。
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| CN114146218A (zh) * | 2021-12-03 | 2022-03-08 | 中国人民解放军空军军医大学 | 一种多孔peek材料的人工骨及其制备方法 |
| CN115137533A (zh) * | 2022-05-05 | 2022-10-04 | 浙江德康医疗器械有限公司 | 一种个性化动态监测成骨活性脊柱融合系统 |
| CN115414159A (zh) * | 2022-09-19 | 2022-12-02 | 中国人民解放军联勤保障部队第九二〇医院 | 一种人工舟骨假体及其制备方法与制备工具 |
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| CN115137533A (zh) * | 2022-05-05 | 2022-10-04 | 浙江德康医疗器械有限公司 | 一种个性化动态监测成骨活性脊柱融合系统 |
| CN115414159A (zh) * | 2022-09-19 | 2022-12-02 | 中国人民解放军联勤保障部队第九二〇医院 | 一种人工舟骨假体及其制备方法与制备工具 |
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