CN112603602A - 一种生物活性椎间融合器及其制造方法 - Google Patents
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Abstract
本发明公开了一种生物活性椎间融合器及其制造方法,所述椎间融合器包括外层,包裹在所述外层内的中间层,以及安装在所述中间层内的内层;所述外层为软材料,可以是水凝胶,也可以是硅胶等;所述中间层为多孔结构,内部孔道完全贯通,可以是钛合金,也可以是PEEK等;所述内层为多孔结构的生物活性陶瓷材料,内部孔道完全贯通,可以是钙镁硅酸盐,硅酸盐,或者磷酸盐等。所述的中间层包括进入口和轨道,所述内层通过所述进入口进入中间层内部,所述内层活动安装在所述轨道上。本发明的生物活性椎间融合器具有高的力学强度,良好的位置稳定性,而且具有好的生物活性。
Description
技术领域
本发明涉及一种医疗器械技术领域的器械及其制造方法,尤其是涉及一种生物活性椎间融合器及其制造方法。
背景技术
随着人口老龄化的加剧,以颈肩痛及腰腿痛为主要症状的脊柱退行性疾病正严重地影响人们的工作和生活。在椎体间进行椎体融合术是目前治疗脊柱退行性疾病主要方法之一。自从Kuslich等于1988年首次将椎间融合器用于腰椎椎间融合术以来,各种材质的椎间融合器相继问世,并逐步应用于临床。
经过科研工作者的不懈努力,不同种类的椎间融合器陆续开发出来并逐步应用于临床。理想的椎间融合器需要能纠正脊柱畸形,恢复正常的生理曲度,保持椎间隙的稳定,最重要的是促进骨融合。但是现在的融合器仍然存在很多的不足,包括融合器材料生物相容性的问题、椎间隙塌陷、迟发性炎症反应等等。
随着材料学、生物力学、组织工程学、机械等学科的发展,研究人员正通过多学科联合研究新型椎间融合器,但是无论融合器的材料怎么变化,都必须满足以下要求:融合器在人体内无毒副作用,还要有较好的生物相容性;有适合的生物力学特征;要保证椎间隙的稳定性并促进骨融合;植入人体后,要与上下椎体有更大的融合面积,在结构上要更加接近人体正常的生理曲度。
发明内容
本发明针对现有技术存在的上述不足,提供一种生物活性椎间融合器及其制造方法。
为达到上述目的,本发明采用的技术方案如下:
一种生物活性椎间融合器,所述椎间融合器包括外层,包裹在所述外层内的中间层,以及安装在所述中间层内的内层;
所述外层为软材料,可以是水凝胶,也可以是硅胶等;
所述中间层为多孔结构,内部孔道完全贯通,可以是钛合金,也可以是PEEK等;
所述内层为多孔结构的生物活性陶瓷材料,内部孔道完全贯通,可以是钙镁硅酸盐,硅酸盐,或者磷酸盐等。
优选的,所述的生物活性椎间融合器的中间层包括进入口和轨道,所述内层通过所述进入口进入中间层内部,所述内层活动安装在所述轨道上,所述中间层根据应用场合的需要,整个结构可以进行镂空处理,通过拓扑结构优化,使得整个融合器在满足力学性能要求的前提下,有更轻的重量,中间层主要用来承受外部载荷。
优选的,所述中间层的孔隙率为30~60%,孔径为50~500微米,孔形态结构可以是正方形,长方形,平行四边形,球形等等。
优选的,所述中间层内的进入口和轨道组成一个单元,所述单元可以是1个,也可以是2个,或者更多个。在实际应用的时候,根据中间层的结构和所需要的内层数量来确定单元的数量,以及通过中间层的结构来确定单元在中间层内部的位置。
优选的,所述的生物活性椎间融合器的内层的孔隙率为50~90%,孔径为300~1000微米,厚度为0.5~5mm,孔形态结构可以是网格正方形,长方形,平行四边形等等,内层可以是1个,2个或者更多个。
优选的,所述的生物活性椎间融合器的内层的外部形状跟所述中间层的进入口的形状相同,可以是三角形,圆形等,所述内层的外部形状跟所述轨道的截面形状相配合,所述内层的尺寸比所述进入口的尺寸略小,内层能够通过进入口进入到所述中间层的内部。通过进入口结构的设计,所述内层只能在一种位置状态下才能通过进入口达到中间层内部,当内层进入到中间层内部后,内层会跟所述中间层内的轨道配合,保证内层在中间层内部是一个相对稳定的位置状态,例如当内层的形状为三角形时,轨道的截面形状为V型,当内层的形状为圆形时,轨道的截面形状为半圆型,当多个内层进入到轨道上时,内层会在轨道上进行横向的水平移动,并且很难从进入口出来,保证内层一直在中间层内部。
在实际应用的时候,通过将外层包裹在中间层外面,可以避免硬材料直接跟周围硬骨接触,产生磨损。通过调节中间层的孔隙率,孔径和孔形态结构,可以调节中间层的力学强度。通过调节内层的孔隙率,孔径,孔形态结构以及中间层的孔隙率,可以控制生物材料的降解速度以及离子释放速度。通过调节内层的数量,可以控制生物活性离子的释放量。
优选的,本发明涉及上述生物活性椎间融合器的制造方法,包括以下步骤:
1)根据应用场合分别选择中间层,外层和内层的材料类型;
2)根据应用场合和中间层的材料特性设计中间层的结构,然后利用设备制造中间层;
3)根据中间层的结构和外层的材料特性,设计外层的结构,然后制造外层;
4)根据应用场合和内层的材料特性设计内层的结构,将内层材料跟溶剂混合得到分散均匀的生物墨水,然后利用3D打印设备制造内层毛坯;
5)将内层毛坯放到高温炉中高温煅烧,冷却后得到内层;
6)将多个内层结构经过中间层的进入口放置到轨道上;
7)用外层将含有内层的中间层结构包裹住,得到生物活性椎间融合器。
优选的,所述的煅烧温度为1000oC-1150oC,升温速度为1-3 oC/min,保温时间1-6小时。
与现有技术相比,本发明具有如下优点:
一、本发明制造的生物活性椎间融合器表面结构较软,不易与接触部位发生磨损。
二、本发明制造的生物活性椎间融合器在体内有好的生物活性,能够促进骨再生修复。
三、本发明的制造生物活性椎间融合器的方法操作方便,制造成本低。
附图说明
图1是本发明的生物活性椎间融合器的制造方法流程示意图;
图2是本发明的生物活性椎间融合器结构示意图;
图3是本发明的一种生物活性椎间融合器的部分结构示意图。
具体实施方式
下面对本发明的实施例作详细说明,本实施例在以本发明技术方案为前提下进行实施,给出了详细的实施方式和具体的操作过程,但本发明的保护范围不限于下述的实施例。
如图2和图3所示,本发明一种生物活性椎间融合器,所述椎间融合器包括外层,包裹在上述外层内的中间层,以及安装在上述中间层内的内层;
上述外层为软材料,可以是水凝胶,也可以是硅胶等;
上述中间层为多孔结构,内部孔道完全贯通,可以是钛合金,也可以是PEEK等;
上述内层为多孔结构的生物活性陶瓷材料,内部孔道完全贯通,可以是钙镁硅酸盐,硅酸盐,或者磷酸盐等。
上述生物活性椎间融合器的中间层包括进入口和轨道,上述内层通过上述进入口进入中间层内部,上述内层活动安装在上述轨道上,上述中间层根据应用场合的需要,整个结构可以进行镂空处理,通过拓扑结构优化,使得整个融合器在满足力学性能要求的前提下,有更轻的重量,中间层主要用来承受外部载荷。
上述中间层的孔隙率为30~60%,孔径为50~500微米,孔形态结构可以是正方形,长方形,平行四边形,球形等等。
上述中间层内的进入口和轨道组成一个单元,所述单元可以是1个,也可以是2个,或者更多个。在实际应用的时候,根据中间层的结构和所需要的内层数量来确定单元的数量,以及通过中间层的结构来确定单元在中间层内部的位置。
上述生物活性椎间融合器的内层的孔隙率为50~90%,孔径为300~1000微米,厚度为0.5~5mm,孔形态结构可以是网格正方形,长方形,平行四边形等等,内层可以是1个,2个或者更多个。
上述生物活性椎间融合器的内层的外部形状跟上述中间层的进入口的形状相同,可以是三角形,圆形等,上述内层的外部形状跟上述轨道的截面形状相配合,上述内层的尺寸比上述进入口的尺寸略小,内层能够通过进入口进入到上述中间层的内部。通过进入口特殊结构的设计,上述内层只能在一种位置状态下才能通过进入口达到中间层内部,当内层进入到中间层内部后,内层会跟所述中间层内的轨道配合,保证内层在中间层内部是一个相对稳定的位置状态,例如当内层的形状为三角形时,轨道的截面形状为V型,当内层的形状为圆形时,轨道的截面形状为半圆型,当多个内层进入到轨道上时,内层会在轨道上进行横向的水平移动,并且很难从进入口出来,保证内层一直在中间层内部。
在实际应用的时候,通过将外层包裹在中间层外面,可以避免硬材料直接跟周围硬骨接触,产生磨损。通过调节中间层的孔隙率,孔径和孔形态结构,可以调节中间层的力学强度。通过调节内层的孔隙率,孔径,孔形态结构以及中间层的孔隙率,可以控制生物材料的降解速度以及离子释放速度。通过调节内层的数量,可以控制生物活性离子的释放量。
如图1所示,是本发明的生物活性椎间融合器的制造方法流程示意图,包括以下步骤:
1)根据应用场合分别选择中间层,外层和内层的材料类型;
2)根据应用场合和中间层的材料特性设计中间层的结构,然后利用设备制造中间层;
3)根据中间层的结构和外层的材料特性,设计外层的结构,然后制造外层;
4)根据应用场合和内层的材料特性设计内层的结构,将内层材料跟溶剂混合得到分散均匀的生物墨水,然后利用3D打印设备制造内层毛坯;
5)将内层毛坯放到高温炉中高温煅烧,冷却后得到内层;
6)将多个内层结构经过中间层的进入口放置到轨道上;
7)用外层将含有内层的中间层结构包裹住,得到生物活性椎间融合器。
上述煅烧温度为1000oC-1150oC,升温速度为1-3 oC/min,保温时间1-6小时。
实施例1
用于腰椎间融合术的椎间融合器制造方法如下:
1)选择钛合金作为中间层的材料,硅胶作为外层的材料,镁含量为1.6%的钙镁硅酸盐作为内层的材料;
2)根据椎间融合器需要的力学特性以及钛合金的材料特性设计钛合金中间层的外形轮廓,内部孔隙率为30%,孔径为100微米,孔形态结构为网格型,中间层内有2个单元,分别布置在中间层的最上面和最下面,进入口的形状为三角形,轨道的截面形状为V型,然后把设计的中间层结构模型导入金属3D打印设备,通过选区激光熔融工艺层层叠加得到钛合金中间层结构;
3)根据中间层的上下表面结构和硅胶的材料特性,设计外层的结构跟中间层的上下表面结构相同,尺寸比中间层的上下表面结构略小,保证硅胶能够牢固的包裹在中间层外,然后利用浇注法制造硅胶外层结构;
4)根据腰椎间融合术需要的骨再生特性和修复特性,以及钙镁硅酸盐的材料特性设计内层的结构,孔隙率为60%,孔径为500微米,孔形态结构为网格正方形,内层的形状为跟进入口一样的三角形,但尺寸比进入口小0.5mm,内层的形状尺寸跟轨道的截面形状尺寸刚好配合,将钙镁硅酸盐粉体跟溶剂混合得到分散均匀的生物墨水,把内层的结构模型导入到3D打印设备内,然后利用3D打印设备层层叠加得到内层毛坯;
5)将内层毛坯放到高温炉中,经1100oC高温煅烧4小时后,冷却后得到内层;
6)将1个内层结构经过中间层上表面的进入口放置到轨道上,然后倾斜中间层让内层结构沿着轨道移动到轨道的另一端,接着平放中间层,让第二个内层结构经进入口放置到轨道上,再次倾斜中间层,让第二个内层结构移动到轨道的另一端,跟第一个内层结构接触,如此继续操作,直到6个内层结构都位于中间层上表面的轨道上,然后翻转中间层,往中间层的下表面的进入口中加入内层结构,跟上表面加入内层结构的操作过程一样,下表面的轨道上装满6个内层结构,最后得到载有上下表面各6个内层结构的中间层;
7)用步骤3)中得到的硅胶分别包裹住步骤6)中得到的中间层的上表面和外表面,得到生物活性椎间融合器,关键部分的结构示意图如图2所示。
Claims (4)
1.一种生物活性椎间融合器,其特征在于,所述椎间融合器包括外层,包裹在所述外层内的中间层,以及安装在所述中间层内的内层;
外层为软材料,为水凝胶或硅胶;
所述中间层为多孔结构,内部孔道完全贯通,选用钛合金或PEEK;
所述内层为多孔结构的生物活性陶瓷材料,内部孔道完全贯通,选用钙镁硅酸盐,硅酸盐或者磷酸盐;
所述的生物活性椎间融合器的中间层包括进入口和轨道,所述内层通过所述进入口进入中间层内部,所述内层活动安装在所述轨道上;
所述中间层的孔隙率为30~60%,孔径为50~500微米,孔形态结构为正方形,长方形,平行四边形或球形;
所述中间层内的进入口和轨道组成一个单元,所述单元有多个;
所述内层的孔隙率为50~90%,孔径为300~1000微米,厚度为0.5~5mm,孔形态结构为网格正方形,长方形或平行四边形,内层至少一个。
2.根据权利要求1所述的生物活性椎间融合器,其特征在于,所述的生物活性椎间融合器的内层的外部形状跟所述中间层的进入口的形状相同,所述内层的外部形状跟所述轨道的截面形状相配合,所述内层的尺寸比所述进入口的尺寸略小,内层能够通过进入口进入到所述中间层的内部。
3.一种根据权利要求1所述的生物活性椎间融合器的制造方法,其特征在于,包括以下步骤:
1)根据应用场合分别选择中间层,外层和内层的材料类型;
2)根据应用场合和中间层的材料特性设计中间层的结构,然后利用设备制造中间层;
3)根据中间层的结构和外层的材料特性,设计外层的结构,然后制造外层;
4)根据应用场合和内层的材料特性设计内层的结构,将内层材料跟溶剂混合得到分散均匀的生物墨水,然后利用3D打印设备制造内层毛坯;
5)将内层毛坯放到高温炉中高温煅烧,冷却后得到内层;
6)将多个内层结构经过中间层的进入口放置到轨道上;
7)用外层将含有内层的中间层结构包裹住,得到生物活性椎间融合器。
4.根据权利要求3所述的生物活性椎间融合器的制造方法,其特征在于,所述的煅烧温度为1000oC-1150oC,升温速度为1-3 oC/min,保温时间1-6小时。
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