CN107693172A - 一种3d打印个性化定制人工椎体及其制备方法 - Google Patents
一种3d打印个性化定制人工椎体及其制备方法 Download PDFInfo
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Abstract
一种3D打印个性化定制人工椎体及其制备方法。本发明对缺损椎体行术前CT扫描建立三维模型,通过优化设计,打印出3D多孔仿生个体化脊柱椎体,并通过生物活性处理提高其生物相容性。本发明与现技术相比,个性化椎体精准替代缺损,提高了人工椎体即时稳定性,活性处理改善椎体生物相容性,提高椎体与周围骨结合能力,有利于人工椎体在体内的长期稳定。
Description
技术领域
本发明设计了一种全脊柱椎体切除术后,脊柱椎体重建领域,具体涉及一种3D打印个性化定制人工椎体及其制备方法。
背景技术
椎体肿瘤、结核、骨折等多种因素常常可导致椎体严重的破坏,造成脊柱骨折,失稳,出现神经、脊髓损害症状,甚至出现截瘫。这类患者往往需要手术将病椎切除,使得脊髓充分减压,从而缓解疼痛,改善神经激素功能。但是手术会造成局部骨质缺损,脊柱连续性破坏,严重影响脊柱支撑功能以及稳定性。因而恢复脊柱的连续性,重建脊柱的稳定性就显得至关重要。目前脊柱肿瘤的发病率逐年提高,脊柱结核和脊柱骨折导致的椎体破坏也呈上升趋势,每年都有大量的患者需要进行全椎体的置换,对整个社会都是沉重的医疗负担。目前对于椎体重建采用的方法主要有:①植骨重建,包括自体骨块与异体骨块移植;②假体重建,包括钛网和人工椎体。
目前自体髂骨移植,存在骨量不足、供骨区并发症及不能提供即刻稳定等缺点,异体骨移植但存在免疫排斥反应、感染病毒、异体骨被取代慢,临床应用受到限制。而对于传统钛网和钛合金人工椎体,其强度大,但弹性模量(110GPa)远远高于天然骨(皮质骨约3-12GPa),存在金属-骨的界面问题,会产生应力屏蔽,导致骨吸收而发生植入体松动,塌陷,移位等并发症。
发明内容
本发明的目的在于提供一种通过3D打印实现个体化定制假体,使其更好的与上下椎体匹配。同时通过生物活性处理提高人工椎体的生物相容性,诱导新骨生长,从而达到良好的骨整合,促进人工椎体的骨性融合的3D打印个性化定制人工椎体及其制备方法。
为达到上述目的,本发明3D打印个性化定制人工椎体包括中空、两端通透的高度与缺损椎体相邻的正常椎体终板之间距离相等的多孔纺锤型人工椎体,椎体两端直径小于病椎相邻的正常椎体终板外径2mm-4mm;椎体中段直径为两端终板等比缩小25%-35%并与两端连接形成流线体,多孔纺锤型人工椎体的孔径0.4mm-0.6mm,丝径0.25mm-0.4mm,孔隙率55%-75%;椎体上、下两端有向内平行延伸1mm-3mm,厚度为2mm的上、下端屋檐多孔结构,沿上、下端屋檐多孔结构向内平行延伸有厚1mm-1.5mm,宽2mm的上、下端环形实体梁,椎体中部设置有中间环形实体梁,椎体中轴线的矢状位和冠状位各设置一组高度与椎体一致厚1.5mm-2.5mm,宽3mm的前后、左右实体梁。
所述的多孔结构8采用正十二面体结构或者骨小梁结构。
本发明3D打印个性化定制人工椎体的制备方法包括以下步骤:
1)多孔钛合金个性化人工椎体制备
将待打印的个性化定制人工椎体模型数据输入EBM设备,并在EBM设备中加入钛合金粉末,首先在650℃以30mA的电子束流,以15000mm/s的扫描速度预热粉末,然后以6mA的电子束流,400mm/s的扫描速度逐层熔化钛合金粉末,最后制备成与预期形状一致的多孔钛合金个性化人工椎体;
2)人工椎体活性处理
2-1)构建微米级氧化钛活性表面涂层
将制备的多孔钛合金个性化人工椎体作为工作电极,采用恒电压模式制备涂层:将制备的多孔钛合金个性化人工椎体置于醋酸钙浓度为0.2mol/L,β甘油磷酸钠浓度为0.04mol/L的电解液,在频率为200Hz,占空比为15%,以恒定350V电压下脉冲-直流电源对试件进行微弧氧化处理后在恒温水浴下再处理5min,得到表面具有氧化钛的多孔钛合金个性化人工椎体;
2.2构建纳米级钛酸钡压电活性表面涂层
以表面具有氧化钛的多孔钛合金个性化人工椎体作为钛源,原位自转化合成钛酸钡压电陶瓷涂层:在100-120℃下不锈钢高压反应釜中,将表面具有氧化钛的多孔钛合金个性化人工椎体置于Ba2+浓度为0.25mol/L的Ba(OH)2溶液中,采用NaOH调节PH值至13,反应压力控制在0.7-1.1MPa,反应时间1-3小时,氧化钛溶解与溶液中的钡离子原位反应在氧化钛的多孔钛合金个性化人工椎体表面生成钛酸钡。
本发明通过3D打印技术,对需要修复的缺损椎体行个体化设计重建,使人工椎体与邻近阶段精确匹配。在保证足够机械强度的前提下,通过控制孔隙率、孔径大小、孔的形状及分布等多种参数,有效降低人工椎体的弹性模量,实现与自然骨的弹性模量相匹配。同时通过多多孔钛合金人工椎体得活化处理,促进骨组织长入,增强人工椎体的机械锁固,从而获得更好的长期固定效果。
由于反应不外加钛源,钛合金或氧化钛溶解与钛酸钡形成同步发生,钛酸钡晶体在钛合金表面优先形核,钛合金或氧化钛不断溶解供给钛酸钡晶体长大。从而获得结合牢固、负载均匀压电陶瓷涂层。
附图说明
图1为本发明制备的个性化定制人工椎体的整体结构示意图;
图2为本发明制备的个性化定制人工椎体的剖视图。
具体实施方式
下面结合附图对本发明作进一步详细说明。
参见图1,2,本发明包括中空、两端通透的高度与缺损椎体相邻的正常椎体终板之间距离相等的多孔纺锤型人工椎体,多孔结构8采用正十二面体结构或者骨小梁结构,椎体两端直径小于病椎相邻的正常椎体终板外径2mm-4mm;椎体中段直径为两端终板等比缩小25%-35%并与两端连接形成流线体,多孔纺锤型人工椎体的孔径0.4mm-0.6mm,丝径0.25mm-0.4mm,孔隙率55%-75%;椎体上、下两端有向内平行延伸1mm-3mm,厚度为2mm的上、下端屋檐多孔结构4、5,沿上、下端屋檐多孔结构4、5向内平行延伸有厚1mm-1.5mm,宽2mm的上、下端环形实体梁1、3,椎体中部设置有中间环形实体梁2,椎体中轴线的矢状位和冠状位各设置一组高度与椎体一致厚1.5mm-2.5mm,宽3mm的前后、左右实体梁6、7。
本发明的制备方法如下:
1)多孔钛合金个性化人工椎体制备
将待打印的个性化定制人工椎体模型数据输入EBM设备,并在EBM设备中加入钛合金(Ti6Al4V)粉末,首先在650℃以30mA的电子束流,以15000mm/s的扫描速度预热粉末,然后以6mA的电子束流,400mm/s的扫描速度逐层熔化钛合金粉末,最后制备成与预期形状一致的多孔钛合金个性化人工椎体;
2)人工椎体活性处理
2-1)构建微米级氧化钛活性表面涂层
将制备的多孔钛合金个性化人工椎体作为工作电极,采用恒电压模式制备涂层:将制备的多孔钛合金个性化人工椎体置于醋酸钙浓度为0.2mol/L,β甘油磷酸钠浓度为0.04mol/L的电解液,在频率为200Hz,占空比为15%,以恒定350V电压下脉冲-直流电源对试件进行微弧氧化处理后在恒温水浴下再处理5min,得到表面具有氧化钛的多孔钛合金个性化人工椎体;
2.2构建纳米级钛酸钡压电活性表面涂层
以表面具有氧化钛的多孔钛合金个性化人工椎体作为钛源,原位自转化合成钛酸钡压电陶瓷涂层:在100-120℃下不锈钢高压反应釜中,将表面具有氧化钛的多孔钛合金个性化人工椎体置于Ba2+浓度为0.25mol/L的Ba(OH)2溶液中,采用NaOH调节PH值至13,反应压力控制在0.7-1.1MPa,反应时间1-3小时,氧化钛溶解与溶液中的钡离子原位反应在氧化钛的多孔钛合金个性化人工椎体表面生成钛酸钡。
本发明采用多孔钛合金融合器由电子束熔融技术(Electron Beam Melting)制备,其外部形态为仿生的纺锤形椎体结构,采用规则骨小梁结构,弹性模量等力学性能类似于椎体骨皮质。外周于椎体中轴线的矢状位和冠状位各一组承重梁,高度与椎体一致。
椎体表面活性处理,采用氧化钛活性涂层和纳米级的钛酸钡压电活性表面涂层复合处理。用微弧氧化方法在材料表面产生火花放电斑点,在热化学、等离子体化学和电化学的共同作用下生成氧化钛活性涂层,经过处理的内植物表现出优良的生物学特性。再此基础上采用原位生长的技术制备BaTiO3纳米压电陶瓷涂层,压电陶瓷是一种可以在力学刺激下产生电流,具有压电效应的新型材料,通过力电效应刺激可以有效提高骨长入能力。本方法在保留压电陶瓷压电特性的前提下,大大提高了其与基底材料的结合强度,解决了压电陶瓷涂层与基底材料结合能力较差的问题,使得力学-电学效应在促进骨长入中所发挥效能。从而赋予人工椎体一定的压电性能,提高其骨诱导长入能力,使其早期形成骨整合。
本发明所提供的人工椎体具有与自然骨组织相近的弹性模量,多孔结构允许体液的传输及新生骨组织长入,解决了骨-材料界面结合问题,具有比致密材料更好的力学相容性与骨整合能力。其外周的椎体梁结构,使其具有更高的强度,个体化的纺锤体设计,使其在手术中更容易被安放。中空的设计为植骨预留了空间,使得骨整合更加容易。微米级氧化钛活性涂层和纳米级的钛酸钡压电活性表面涂层复合处理,通过压电效应能发挥持续的骨诱导作用,促进早期骨整合及椎体间骨性融合,达到椎体间的长期稳定。
Claims (3)
1.一种3D打印个性化定制人工椎体,其特征在于,包括中空、两端通透的高度与缺损椎体相邻的正常椎体终板之间距离相等的多孔纺锤型人工椎体,椎体两端直径小于病椎相邻的正常椎体终板外径2mm-4mm;椎体中段直径为两端终板等比缩小25%-35%并与两端连接形成流线体,多孔纺锤型人工椎体的孔径0.4mm-0.6mm,丝径0.25mm-0.4mm,孔隙率55%-75%;椎体上、下两端有向内平行延伸1mm-3mm,厚度为2mm的上、下端屋檐多孔结构(4、5),沿上、下端屋檐多孔结构(4、5)向内平行延伸有厚1mm-1.5mm,宽2mm的上、下端环形实体梁(1、3),椎体中部设置有中间环形实体梁(2),椎体中轴线的矢状位和冠状位各设置一组高度与椎体一致厚1.5mm-2.5mm,宽3mm的前后、左右实体梁(6、7)。
2.根据权利要求1所述的3D打印个性化定制人工椎体,其特征在于,所述的多孔纺锤型人工椎体的多孔结构(8)采用正十二面体结构或者骨小梁结构。
3.一种3D打印个性化定制人工椎体的制备方法,其特征在于:
1)多孔钛合金个性化人工椎体制备
将待打印的个性化定制人工椎体模型数据输入EBM设备,并在EBM设备中加入钛合金粉末,首先在650℃以30mA的电子束流,以15000mm/s的扫描速度预热粉末,然后以6mA的电子束流,400mm/s的扫描速度逐层熔化钛合金粉末,最后制备成与预期形状一致的多孔钛合金个性化人工椎体;
2)人工椎体活性处理
2-1)构建微米级氧化钛活性表面涂层
将制备的多孔钛合金个性化人工椎体作为工作电极,采用恒电压模式制备涂层:将制备的多孔钛合金个性化人工椎体置于醋酸钙浓度为0.2mol/L,β甘油磷酸钠浓度为0.04mol/L的电解液,在频率为200Hz,占空比为15%,以恒定350V电压下脉冲-直流电源对试件进行微弧氧化处理后在恒温水浴下再处理5min,得到表面具有氧化钛的多孔钛合金个性化人工椎体;
2.2构建纳米级钛酸钡压电活性表面涂层
以表面具有氧化钛的多孔钛合金个性化人工椎体作为钛源,原位自转化合成钛酸钡压电陶瓷涂层:在100-120℃下不锈钢高压反应釜中,将表面具有氧化钛的多孔钛合金个性化人工椎体置于Ba2+浓度为0.25mol/L的Ba(OH)2溶液中,采用NaOH调节PH值至13,反应压力控制在0.7-1.1MPa,反应时间1-3小时,氧化钛溶解与溶液中的钡离子原位反应在氧化钛的多孔钛合金个性化人工椎体表面生成钛酸钡。
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