CN116059010A - 一种双重梯度排布类骨力学性能的支架及其制备方法和用途 - Google Patents
一种双重梯度排布类骨力学性能的支架及其制备方法和用途 Download PDFInfo
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Abstract
本发明提供了一种双重梯度排布类骨力学性能的支架及其制备方法和用途,属于生物材料技术领域。该支架同时具有随机晶格梯度排布和杆径梯度排布结构。该支架可模仿骨结构和性能,具有仿生优势。该支架在高孔隙率的同时可保证良好的力学性能,接近真实骨骼结构,满足承重区骨骼力学要求;同时,该支架具有良好的生物活性,在骨重建过程中,可以防止应力遮挡发生,提高骨整合的能力,有效地诱导支架内部血管化以及骨长入。此外,该支架建模难度小,并结合3D打印技术,流程简单,耗时短,患者可以及时手术进行治疗。本发明支架在骨缺损区域骨修复中有很强的实用价值。
Description
技术领域
本发明属于生物材料技术领域,具体涉及一种双重梯度排布类骨力学性能的支架及其制备方法和用途。
背景技术
近年来,随着材料学、工程学、生命科学的快速发展,骨组织工程支架材料用于骨缺损修复的研究受到广泛的关注,传统制备工艺加工的多孔支架材料内部孔隙结构不可控、外形与宿主骨缺损不完全匹配,很难满足实际需求。利用3D打印技术制备的多孔支架材料不仅可以构建与缺损骨组织相匹配的复杂外形,还可以精确调控内部孔隙结构,同时可携带生物活性因子及细胞进行骨缺损部位的原位打印,从而获得理想的骨修复效果。
由于骨骼的三维不均匀结构,具有从宏观到纳米尺度的复杂特征。在多孔支架材料中重现天然骨骼的所有细节是不可能完成且没有必要的。但在理想情况下,植入骨支架应在多个尺度上具有相似的层次结构,并且具有与宿主骨骼和周围组织相似的特性。为了获得简化的模型,研究人员通常假设支架是由沿各个方向周期性重复的晶格构成的,而微晶格的结构可以清楚地定义支架的宏观特性,晶格排布方式可以控制支架的微孔结构。
骨支架的多孔结构可以显著影响其机械性能和体内细胞行为。在构建3D支架时,常采用自下而上的方法。也就是说,首先制作晶格单元,然后将其组装到3D支架中。使用这种方法可以基于多孔结构设计来微调机械性能。已有科研团队开发出了计算机辅助系统用于设计组织支架,其可以自动地创建具有受控结构的高度多孔的三维支架模型,并精确天然解剖结构的外表面轮廓相符。根据已有的文献资料,两种最常见的3D打印支架多孔结构是周期性多孔结构与不规则多孔结构。
但是,传统周期性支架晶格排列具有规律性和周期性,不具有仿生性能,无法满足骨组织在生物学性能和机械性能方面的梯度需求。而制造不规则多孔结构所需要的3D打印工艺较高,目前传统支架3D打印工艺缺少深度优化;并且不规则多孔结构建模难度较大,在创建多孔结构网络时,如果需要高质量的渲染,则用小细节表示大表面所需的体素数量可能会轻易超过个人计算机的存储容量。且针对个体的特殊性方面存在较大的设计盲目性。
同时,传统多孔支架有支撑作用和孔隙率不能平衡的矛盾。在支撑作用与孔隙率间的矛盾下很难实现支架的降解速率可控化,并且不具备骨诱导的能力。在力学性能满足修补骨所需的条件下,支架的孔隙率偏小,材料的降解速率明显慢于骨自身的重建速度,并且在该孔隙率下,支架诱导骨再生的能力较低,不利于骨重建。而高孔隙度通常以较低的机械强度为代价而获得,尤其是疲劳强度达不到承重区骨骼的力学要求。
因此,研究一种结构满足生物学性能和机械性能,且方便设计和打印的支架具有重要意义。
发明内容
本发明的目的是提供一种双重梯度排布类骨力学性能的支架及其制备方法和用途。
本发明提供了一种双重梯度排布类骨力学性能的支架,所述支架同时具有随机晶格梯度排布和杆径梯度排布结构。
进一步地,所述随机晶格梯度排布结构中,由支架中心到支架边缘晶格大小逐渐增大,呈线性关系变化。
进一步地,所述随机晶格梯度排布结构中,晶格大小为0.4~1mm。具体是指最小的晶格为0.4mm,最大的晶格为1mm。
进一步地,所述杆径梯度排布结构中,由支架中心到支架边缘杆径大小逐渐增大,呈线性关系变化。
进一步地,所述杆径梯度排布结构中,杆径大小为0.3~0.4mm。具体是指杆径最小为0.3mm,杆径最大为0.4mm。
进一步地,所述支架的孔隙率≥70%,孔径大小处于微米级。
进一步地,所述支架为金属支架;
优选地,所述金属为不锈钢、镍钛合金、铁锰合金或钽金属。
本发明还提供了一种制备前述的支架的方法,它包括如下步骤:
(1)利用ntopology软件设计具有随机晶格梯度排布和杆径梯度排布结构的支架模型;
(2)按照步骤(1)设计的模型,将原料进行3D打印,即得;
优选地,所述3D打印为选择性激光熔融法。
进一步地,所述原料为金属粉末;
优选地,所述金属为不锈钢、镍钛合金、铁锰合金或钽金属。
本发明还提供了前述的支架在制备骨组织修复材料中的用途。
本发明的有益效果:
(1)结构学上,本发明支架同时具有随机晶格梯度排布和杆径梯度排布,随机晶格梯度排布模仿松质骨的孔隙大小和排布,杆径梯度排布模仿松质骨和皮质骨的密度结构和力学性能,该支架具有仿生性能,可以满足骨组织在生物学性能和机械性能方面的梯度需求。
(2)力学性能上,本发明支架承重区力学匹配性良好,可以在高孔隙率的同时保证机械强度,尤其是疲劳强度达到承重区骨骼的力学要求。
(3)生物学上,本发明支架降解可控,有骨诱导的能力,且降解速率可控。
(4)设计上,本发明支架模型建模难度小,使用ntopology软件,成品支架大小仅几百兆。
(5)打印工艺上,本发明支架采用3D打印工艺深度优化,且可以设计出匹配个体的骨修复支架。
综上,本发明设计了具有特定双重梯度排布结构的支架,该支架同时具有随机晶格梯度排布和杆径梯度排布,可模仿骨结构和性能,具有仿生优势。该支架在高孔隙率(≥70%)的同时可保证良好的力学性能(如弹性模量达到4.0GPa以上,压缩强度达到68MPa以上),接近真实骨骼结构,满足承重区骨骼力学要求;同时,该支架具有良好的生物活性,支架降解可控,且具有骨诱导的能力,在骨重建过程中,可以防止应力遮挡发生,提高骨整合的能力,有效地诱导支架内部血管化以及骨长入。此外,该支架建模难度小,并结合3D打印技术,流程简单,耗时短,患者仅需在骨缺损发生后,接受短时间的生物力学和三维受损骨区域数据的采集过程,即可在短时间内获得3D打印的定制产品,可以及时手术进行治疗。本发明支架在骨缺损区域骨修复中有很强的实用价值。
显然,根据本发明的上述内容,按照本领域的普通技术知识和惯用手段,在不脱离本发明上述基本技术思想前提下,还可以做出其它多种形式的修改、替换或变更。
以下通过实施例形式的具体实施方式,对本发明的上述内容再作进一步的详细说明。但不应将此理解为本发明上述主题的范围仅限于以下的实例。凡基于本发明上述内容所实现的技术均属于本发明的范围。
附图说明
图1为实施例1支架模型的主视图。
图2为实施例1支架模型的俯视图。
具体实施方式
本发明具体实施方式中使用的原料、设备均为已知产品,通过购买市售产品获得。
本发明基于仿生骨骼结构,利用随机晶格梯度排布模仿松质骨的孔隙大小和排布,利用杆径梯度排布模仿松质骨和皮质骨的密度结构和力学性能,然后通过扫描骨缺损区域、计算机3D建模以及几何拓扑优化技术,设计具有随机晶格梯度排布和杆径梯度排布,且有良好力学支撑能力和有诱导支架内部血管化和骨长入能力的个性化骨缺损区域修复骨支架。
具体支架的制备方法如下:
1、计算机3D建模
使用ntopology软件进行支架模型的设计,支架晶格类型选择随机晶格梯度排布,使其内部致密、外部稀疏,晶格大小和到中心的距离呈线性关系变化的;支架杆径类型选择杆径梯度排布,使其内部细,外部粗,杆径大小和到中心的距离呈线性关系变化。支架整体孔隙率大于70%,孔径大小处于微米级。
2、3D打印支架
利用SLM(选择性激光熔融)方法,按照上述建模,使用3D打印机进行支架打印,得到本发明支架。所用打印原材料为金属粉末(如:不锈钢、镍钛合金、铁锰合金或钽金属)。
实施例1、本发明的支架制备方法
1、计算机3D建模
使用ntopology软件进行支架模型的设计,支架模型的形状如图1和图2所示,支架模型为内部空心的圆柱体,该圆柱体内径为3mm,外径为11mm,高度为20mm。设置好支架尺寸后,晶格类型选择随机晶格梯度排布,晶格大小为0.4~1mm,内径向外径晶格逐渐增大,且呈线性增大;同时支架杆径类型选择杆径梯度排布,杆径大小为0.3~0.4mm,内径向外径杆径逐渐增大,且呈线性增大。
该结构孔隙率为70%。
2、3D打印支架
利用SLM(选择性激光熔融)方法,按照上述建模,使用3D打印机进行支架打印,得到本发明支架。所用打印原材料为Fe-30Mn(30wt%Mn铁锰合金,即Mn含量为30%的铁锰合金)。
对比例1、其他结构支架的制备
1、计算机3D建模
使用ntopology软件进行支架模型的设计,支架模型的形状与实施例1相同,为内部空心的圆柱体,该圆柱体内径为3mm,外径为11mm,高度为20mm。设置好支架尺寸后,晶格类型选择均匀的金刚石结构,晶格大小为2mm;同时支架杆径大小均匀为0.5mm。
该结构孔隙率为70%。
2、3D打印支架
利用SLM(选择性激光熔融)方法,按照上述建模,使用3D打印机进行支架打印,得到本发明支架。所用打印原材料为Fe-30Mn(30wt%Mn铁锰合金)。
将实施例1和对比例1制备的支架分别进行力学性能测试。材料压缩实验在常温下采用(5565,INSTRON,America)进行,压缩速率为2mm/min。得到的结果如表1所示。
表1.实施例1和对比例1制备的支架的力学性能结果
分组 | 弹性模量(GPa) | 压缩强度(MPa) |
实施例1 | 4.0 | 68.2 |
对比例1 | 1.3 | 66.2 |
该结果说明:本发明同时具有随机晶格梯度排布和杆径梯度排布的支架在高孔隙率的情况下具有良好的力学性能,与其他结构的支架相比,可以在保证甚至提高压缩强度的同时,显著提高弹性模量,更有利于作为骨修复材料使用。
综上,本发明设计了具有特定双重梯度排布结构的支架,该支架同时具有随机晶格梯度排布和杆径梯度排布,可模仿骨结构和性能,具有仿生优势。该支架在高孔隙率(≥70%)的同时可保证良好的力学性能(如弹性模量达到4.0GPa以上,压缩强度达到68MPa以上),接近真实骨骼结构,满足承重区骨骼力学要求;同时,该支架具有良好的生物活性,支架降解可控,且具有骨诱导的能力,在骨重建过程中,可以防止应力遮挡发生,提高骨整合的能力,有效地诱导支架内部血管化以及骨长入。此外,该支架建模难度小,并结合3D打印技术,流程简单,耗时短,患者仅需在骨缺损发生后,接受短时间的生物力学和三维受损骨区域数据的采集过程,即可在短时间内获得3D打印的定制产品,可以及时手术进行治疗。本发明支架在骨缺损区域骨修复中有很强的实用价值。
Claims (10)
1.一种双重梯度排布类骨力学性能的支架,其特征在于:所述支架同时具有随机晶格梯度排布和杆径梯度排布结构。
2.根据权利要求1所述的支架,其特征在于:所述随机晶格梯度排布结构中,由支架中心到支架边缘晶格大小逐渐增大,呈线性关系变化。
3.根据权利要求2所述的支架,其特征在于:所述随机晶格梯度排布结构中,晶格大小为0.4~1mm。
4.根据权利要求1所述的支架,其特征在于:所述杆径梯度排布结构中,由支架中心到支架边缘杆径大小逐渐增大,呈线性关系变化。
5.根据权利要求4所述的支架,其特征在于:所述杆径梯度排布结构中,杆径大小为0.3~0.4mm。
6.根据权利要求1~5任一项所述的支架,其特征在于:所述支架的孔隙率≥70%,孔径大小处于微米级。
7.根据权利要求1~5任一项所述的支架,其特征在于:所述支架为金属支架;
优选地,所述金属为不锈钢、镍钛合金、铁锰合金或钽金属。
8.一种制备权利要求1~7任一项所述的支架的方法,其特征在于:它包括如下步骤:
(1)利用ntopology软件设计具有随机晶格梯度排布和杆径梯度排布结构的支架模型;
(2)按照步骤(1)设计的模型,将原料进行3D打印,即得;
优选地,所述3D打印为选择性激光熔融法。
9.根据权利要求8所述的方法,其特征在于:所述原料为金属粉末;
优选地,所述金属为不锈钢、镍钛合金、铁锰合金或钽金属。
10.权利要求1~7任一项所述的支架在制备骨组织修复材料中的用途。
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