CN110903082A - 一种梯度复合棒材及其制造方法 - Google Patents
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Abstract
本发明公开了一种梯度复合棒材及其制造方法,所述棒材经两次冷冻干燥定型,两次高温烧结而成,棒材笔直,由内层和外层两部分组成,外层均匀包裹在内层外,外层的降解速度低于内层,内层的力学强度高于外层。棒材有高的力学强度和良好的生物活性,棒材在体内可持续吸收,且吸收降解过程有磷酸盐层生成,有利于骨传导。本发明棒材的梯度降解设计,为骨折愈合提供了时间和力学支撑保障,能更好的促进骨折愈合。
Description
技术领域
本发明涉及的是一种医疗器械技术领域的器械及其制造方法,尤其是涉及一种梯度复合棒材及其制造方法。
背景技术
现实生活中,经常会有人骨折,植入内固定植入物,如髓内钉是最常见的治疗方法。但是当前临床上使用的髓内钉主要由不锈钢、钛合金制成,这些合金制成的髓内钉的力学强度与人体骨不匹配,会产生应力遮挡效应,使得骨折愈合治疗效果不佳甚至失败。同时,这类髓内钉植入到体内后会缓慢释放毒性离子或粒子,引发慢性炎症,导致不易痊愈,生物活性差。此外,这类髓内钉在体内不会降解,需要二次手术将其取出,这会引起并发症,而且增加患者的经济负担和痛苦。
可吸收髓内钉可解决上述部分问题,但目前临床可吸收器械基本是聚合物材料制造,如聚乳酸、聚乙烯醇、壳聚糖等,强高低,力学性能难以满足要求,吸收过程产生的酸性物质也会引起排异反应。
因此,需要制造一种高强度的可降解的生物活性髓内钉植入物,随着骨头的愈合,该植入物在体内逐渐降解,不再需要手术取出,而且无毒,有很好的生物活性,前期具有高的力学强度,能够促进骨头愈合,后期慢慢降解完。
发明内容
本发明针对现有技术存在的上述不足,提供一种梯度复合棒材及其制造方法。
为达到上述目的,本发明采用的技术方案如下:
一种梯度复合棒材,所述棒材笔直,由两部分组成,分别内层和外层,所述内层为圆柱体,笔直,截面均匀。所述外层均匀包裹在内层外。所述外层的降解速度低于内层,内层的力学强度高于外层。
优选的,所述内层采用生物活性材料制成,所述生物活性材料是钙镁硅酸盐,镁在钙镁硅酸盐中的质量百分数为0.22~3.2%,所述外层材料可以是羟基磷灰石,磷酸三钙等材料中的一种或混合物。
优选的,所述外层的厚度为0.1~1.5mm。
优选的,本发明涉及上述梯度复合棒材的制造方法,包括以下步骤:
1)将内层和外层材料分别与聚乙烯醇,聚丙烯酸,Surfynol和去离子水按一定的比例均匀混合,得到分散均匀的生物墨水A和B。
2)根据生物墨水A和B的收缩率,分别定做相应的外轮廓A和外模具B。
3)把步骤1)中的生物墨水A慢慢注入到外轮廓A中,然后冷冻2-24小时。
4)把冷冻后的样品冷冻干燥,脱模后在高温炉中高温煅烧,冷却后得到棒材内层。
5)将棒材内层放到外模具B的中心,把步骤1)中的生物墨水B慢慢注入到棒材内层和外模具B之间的缝隙中,然后冷冻2-24小时。
6)把冷冻后的样品冷冻干燥,脱模后高温煅烧2-4小时,冷却后得到梯度复合棒材。
优选的,聚乙烯醇的浓度为4%~15%,生物墨水中所有材料的质量百分比含量为40~70%的生物材料、1~4%的聚乙烯醇、0.3~1%的聚丙烯酸、0.3~1%的Surfynol,剩余量为去离子水。
优选的,所述的外轮廓A可以根据需要随意变换尺寸,内部空心,内壁光滑,样品冷冻干燥完后,能够使外轮廓A与生物墨水分离,可以是玻璃管,石英管等。
进一步的,所述的外轮廓A的壁厚为1-4mm。
优选的,所述的外模具B包括外壳和固定在外壳一端的中心座,所述中心座的中心与棒材内层配合,使得棒材内层能够位于外壳的中心,所述外壳内壁光滑,样品冷冻干燥完后,能够使外壳与生物墨水分离。
更进一步的,通过改变外轮廓A的内径,就能直接改变棒材内层的直径,通过改变外壳的内径,也能直接改变棒材外层的厚度,而外轮廓A和外壳的尺寸很容易改变,因此可以很容易制造任意尺寸,任意外层厚度的梯度复合棒材。
优选的,所述的冷冻为速冻,速冻温度为零下60oC-80oC。
优选的,所述的煅烧温度为1100oC-1200oC,升温速度为1-3 oC/min,保温时间2-5小时。
本发明的工作原理在于,将梯度复合棒材植入到骨折相应的部位,通过棒材的梯度降解和力学强度,实现骨折的愈合,具体工作过程如下:棒材内层提供与人体骨骼匹配的力学强度,为骨折愈合提供力学支撑,前期棒材外层降解的速度慢,为骨折愈合提供时间,这一阶段以骨折愈合为主,当骨折愈合完成90%左右时,棒材外层降解完,棒材内层开始降解,这时自体骨已经能够自我承受人体的载荷,不再需要棒材提供力学支撑,而棒材内层快速降解,最后实现骨折的完美修复,同时,棒材由生物活性材料制成,有很好的生物活性,能够促进骨折愈合。
与现有技术相比,本发明具有如下优点:
一、本发明可以制造高强度的生物活性可降解棒材,弥补了可降解聚合物材料的不足,且其具有很好的笔直度。
二、在满足棒材力学强度的前提下,通过梯度复合结构的设计,能够减缓棒材的降解速度,即减慢棒材的力学强度衰弱速度,能够为骨折愈合提供足够的时间。
三、本发明的制造梯度复合棒材的方法操作方便,制造成本低。
四、本发明制造的梯度复合棒材在体内可持续吸收,且吸收降解过程有磷酸盐层生成,有利于骨传导。
附图说明
图1是本发明的梯度复合棒材的制造方法流程示意图;
图2是本发明的梯度复合棒材的结构示意图;
图3是本发明的梯度复合棒材力学强度衰变和降解示意图;
其中:1为内层,2为外层。
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,本发明所属领域的技术人员还可以对下述实施方案进行变更和修改,因此,对发明的一些修改和变更也应当落入本发明的权利要求的保护范围内。
如图2所示,本发明一种梯度复合棒材,所述棒材笔直,由2部分组成,包括内层1和外层2,所述内层1为圆柱体,笔直,截面均匀,所述外层2均匀包裹在内层外,所述外层的降解速度低于内层,内层的力学强度高于外层。
优选的,上述内层采用生物活性材料制成,所述生物活性材料是钙镁硅酸盐,镁在钙镁硅酸盐中的质量百分数为0.22~3.2%,上述外层材料可以是羟基磷灰石,磷酸三钙等材料中的一种或混合物。上述外层的厚度为0.1~1.5mm。
如图1所示,是本发明的梯度复合棒材的制造方法流程示意图,包括以下步骤:
1)将内层和外层材料分别与聚乙烯醇,聚丙烯酸,Surfynol和去离子水按一定的比例均匀混合,得到分散均匀的生物墨水A和B。
2)根据生物墨水A和B的收缩率,分别定做相应的外轮廓A和外模具B。
3)把步骤1)中的生物墨水A慢慢注入到外轮廓A中,然后冷冻2-24小时。
4)把冷冻后的样品冷冻干燥,脱模后在高温炉中高温煅烧,冷却后得到棒材内层。
5)将棒材内层放到外模具B的中心,把步骤1)中的生物墨水B慢慢注入到棒材内层和外模具B之间的缝隙中,然后冷冻2-24小时。
6)把冷冻后的样品冷冻干燥,脱模后高温煅烧2-4小时,冷却后得到梯度复合棒材。
聚乙烯醇的浓度为4%~15%,生物墨水中所有材料的质量百分比含量为40~70%的生物材料、1~4%的聚乙烯醇、0.3~1%的聚丙烯酸、0.3~1%的Surfynol,剩余量为去离子水。
上述的外轮廓A可以根据需要随意变换尺寸,内部空心,内壁光滑,样品冷冻干燥完后,能够使外轮廓A与生物墨水分离,可以是玻璃管,石英管等。
进一步的,上述外轮廓A的壁厚为1-4mm。
上述外模具B包括外壳和固定在外壳一端的中心座,所述中心座的中心与棒材内层配合,使得棒材内层能够位于外壳的中心,所述外壳内壁光滑,样品冷冻干燥完后,能够使外壳与生物墨水分离。
更进一步的,通过改变外轮廓A的内径,就能直接改变棒材内层的直径,通过改变外壳的内径,也能直接改变棒材外层的厚度,而外轮廓A和外壳的尺寸很容易改变,因此可以很容易制造任意尺寸,任意外层厚度的梯度复合棒材。
上述的冷冻为速冻,速冻温度为零下60oC-80oC。
上述的煅烧温度为1100oC-1200oC,升温速度为1-3 oC/min,保温时间2-5小时。
本发明的工作原理在于,将梯度复合棒材植入到骨折相应的部位,通过棒材的梯度降解和力学强度,实现骨折的愈合,具体工作过程如下:棒材内层提供与人体骨骼匹配的力学强度,为骨折愈合提供力学支撑,前期棒材外层降解的速度慢,为骨折愈合提供时间,这一阶段以骨折愈合为主,当骨折愈合完成90%左右时,棒材外层降解完,棒材内层开始降解,这时自体骨已经能够自我承受人体的载荷,不再需要棒材提供力学支撑,而棒材内层快速降解,最后实现骨折的完美修复,棒材的降解跟力学强度之间的关系如图3所示,同时,棒材由生物活性材料制成,有很好的生物活性,能够促进骨折愈合。
实施例1
1)将质量百分比为55%的钙镁硅酸盐粉体与2.1%的聚乙烯醇,0.5%的聚丙烯酸,0.5%的Surfynol和41.9%的去离子水均匀混合,得到生物墨水A,再将质量百分比为50%的羟基磷灰石与2.2%的聚乙烯醇,0.5%的聚丙烯酸,0.5%的Surfynol和46.8%的去离子水均匀混合,得到生物墨水B。
2)根据生物墨水A和B的收缩率,定做内径为6.8mm,壁厚为1.6mm的石英管外轮廓A,内径为6.1mm,壁厚为1mm的外壳以及与之配合的中心座。
3)把外轮廓A竖起来,然后将步骤1)中配好的生物墨水A由下往上慢慢注入到外轮廓A中,注满后将生物墨水A连同外轮廓A一起在零下70oC的环境中冷冻3小时。
4)把上述冷冻后的样品经冷冻干燥机冷冻干燥后分离生物墨水A毛坯棒与外轮廓A,把生物墨水A毛坯棒放到高温炉中,经1150oC高温煅烧4小时,冷却后得到直径为5mm的生物墨水A棒材,即棒材内层。
5)将定做的外壳和中心座组装到一起,把生物墨水A棒材放入外壳内,棒材的一端位于中心座的中心,然后把步骤1)中的生物墨水B慢慢注入到生物墨水A棒材和外壳之间的缝隙中,注满后将生物墨水B连同生物墨水A棒材和外模具B一起在零下70oC的环境中冷冻2小时。
6)把上述冷冻后的样品经冷冻干燥机冷冻干燥后分离棒材与外模具B,然后把生物墨水A棒材和生物墨水B的复合棒材放到高温炉中,经1100oC高温煅烧3小时,冷却后得到直径为6mm的梯度复合棒材。
上述实施例制备得到的棒材在满足力学强度的前提下,通过复合结构梯度降解的设计,能够更好的促进骨折愈合,而且,在体内能够降解,具有很好的生物活性。
Claims (10)
1.一种梯度复合棒材,其特征在于,所述棒材笔直,由两部分组成,分别为内层和外层;所述内层为圆柱体,笔直,截面均匀;所述外层均匀包裹在内层外;所述外层的降解速度低于内层,内层的力学强度高于外层。
2.根据权利要求1所述的梯度复合棒材,其特征在于,所述内层采用生物活性材料制成,所述生物活性材料是钙镁硅酸盐,镁在钙镁硅酸盐中的质量百分数为0.22~3.2%,所述外层材料为羟基磷灰石、磷酸三钙或两者的混合物。
3.根据权利要求1所述的梯度复合棒材,其特征在于,所述外层的厚度为0.1~1.5mm。
4.一种根据权利要求1所述的梯度复合棒材的制造方法,其特征在于,包括以下步骤:
1)将内层和外层材料分别与聚乙烯醇,聚丙烯酸,Surfynol和去离子水按一定的比例均匀混合,得到分散均匀的生物墨水A和B;
2)根据生物墨水A和B的收缩率,分别定做相应的外轮廓A和外模具B;
3)把步骤1)中的生物墨水A慢慢注入到外轮廓A中,然后冷冻2-24小时;
4)把冷冻后的样品冷冻干燥,脱模后在高温炉中高温煅烧,冷却后得到棒材内层;
5)将棒材内层放到外模具B的中心,把步骤1)中的生物墨水B慢慢注入到棒材内层和外模具B之间的缝隙中,然后冷冻2-24小时;
6)把冷冻后的样品冷冻干燥,脱模后高温煅烧2-4小时,冷却后得到梯度复合棒材。
5.根据权利要求4所述的梯度复合棒材的制造方法,其特征在于,所述的外轮廓A根据需要变换尺寸,内部空心,内壁光滑;样品冷冻干燥完后,能够使外轮廓A与生物墨水分离。
6.根据权利要求4所述的梯度复合棒材的制造方法,其特征在于,可所述的外轮廓A为玻璃管或石英管。
7.根据权利要求4所述的梯度复合棒材的制造方法,其特征在于,所述的外轮廓A的壁厚为1-4mm。
8.根据权利要求4所述的梯度复合棒材的制造方法,其特征在于,所述的外模具B包括外壳和固定在外壳一端的中心座,所述中心座的中心与棒材内层配合,所述外壳内壁光滑,样品冷冻干燥完后,能够使外壳与生物墨水分离。
9.根据权利要求4所述的梯度复合棒材的制造方法,其特征在于,所述的冷冻为速冻,速冻温度为零下60oC-80oC。
10.根据权利要求4所述的梯度复合棒材的制造方法,其特征在于,所述的煅烧温度为1100oC-1200oC,升温速度为1-3 oC/min,保温时间2-5小时。
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