CN106620892B - 一种可降解高分子冠脉血管支架及其制备方法 - Google Patents
一种可降解高分子冠脉血管支架及其制备方法 Download PDFInfo
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Abstract
本发明涉及可植入医疗器械领域,具体为一种可降解高分子冠脉血管支架,包括:镁合金、复合层、可降解聚酯聚合物和淀粉;所述镁合金包括有(按质量百分比计):锌15‑23%、硅0.3‑0.7%、钙1‑2%、微量元素2‑3.6%,余量为镁;所述复合层包括有(按质量百分比计):加固纤维12‑23%、磷酸三钙15‑21%和琼脂61‑72%,余量为水。本发明还公开了一种可降解高分子冠脉血管支架的制备方法,该血管支架由以下步骤制得:S1:骨架制作;S2:粗糙度处理;S3:复合层制取;S4:将S3步骤中制得的复合层均匀涂抹在血管支架主体上;本发明的配方更加简单,并且更加的科学合理,能够很大程度上降低患者的痛苦,减少药物的使用,避免后期的手术次数,利于推广。
Description
技术领域
本发明涉及可植入医疗器械领域,具体为一种可降解高分子冠脉血管支架及其制备方法。
背景技术
随着医疗技术的不断进步和发展,可植入医疗器械越来越受到重视,并被普及使用,在对冠脉血管进行相关的医疗操作时,需要用到血管支架对导管进行支撑作用,支架在满足使用刚性的同时,还需要达到被身体吸收和降解的目的,进而更为方便患者的使用,减少患者的医疗费用以及痛苦,现有技术下的可降解血管支架技术相对不成熟,不能够更好的方便使用,效果较差。
发明内容
本发明的目的在于提供一种可降解高分子冠脉血管支架及其制备方法,以解决上述背景技术中提出的问题。
为实现上述目的,本发明提供如下技术方案:一种可降解高分子冠脉血管支架,包括:镁合金、复合层、可降解聚酯聚合物和淀粉;
所述镁合金包括有(按质量百分比计):锌15-23%、硅0.3-0.7%、钙1-2%、微量元素2-3.6%,余量为镁;
所述复合层包括有(按质量百分比计):加固纤维12-23%、磷酸三钙15-21%和琼脂61-72%,余量为水。
优选的,所述镁合金包括有(按质量百分比计):锌16%、硅0.4%、钙1.3%、微量元素2.4%,镁79.9%,所述复合层包括有(按质量百分比计):加固纤维14%、磷酸三钙17%和琼脂67.5%,水1.5%。
优选的,所述镁合金包括有(按质量百分比计):锌18%、硅0.5%、钙1.7%、微量元素3%,镁76.8%,所述复合层包括有(按质量百分比计):加固纤维18%、磷酸三钙16%和琼脂63%,水2%。
优选的,所述镁合金包括有(按质量百分比计):锌22%、硅0.6%、钙1.8%、微量元素3.6%,镁72%,所述复合层包括有(按质量百分比计):加固纤维13%、磷酸三钙18%和琼脂68%,水1%。
优选的,所述微量元素由硅、钇、锰、铝、铜中的一种或多种组成。
优选的,所述可降解聚酯聚合物为聚乙醇酸、聚已内酯、聚己二酸乙二醇酯和聚乳酸-乙 醇酸共聚物。
优选的,所述加固纤维为可降解短纤维。
一种可降解高分子冠脉血管支架的制备方法,该血管支架由以下步骤制得:
S1:骨架制作:将锌、硅、钙、微量元素及镁作为原料,一体铸造出骨架和连接件,并且通过连接件合理制作出血管支架主体;
S2:粗糙度处理:将血管支架主体放置在喷涂设备中,将熔融状态下的石蜡通过喷涂设备在血管支架主体的表面进行喷涂,石蜡在血管支架主体表面形成不规则点状凸起,然后将血管支架主体经过酸洗,控制酸洗时间在10-35s之间,将血管支架主体拿出,用水洗净;
S3:复合层制取:将琼脂放入到容器中,控制加热时间在20-35min,缓慢加热溶解,将加固纤维、磷酸三钙依次加入到容器中,搅拌,保温,得到复合层;
S4:将S3步骤中制得的复合层均匀涂抹在血管支架主体上,保持复合层的厚度小于0.13mm ;
S5:在淀粉中加入水以及可降解聚酯聚合物,搅拌,微热,保持加热温度在35℃以下,搅拌均匀后涂抹在复合层的表面;
S6:将S5步骤中得到的血管支架主体通过镜面处理,至此该可降解高分子冠脉血管支架制备完成。
与现有技术相比,本发明的有益效果是:本发明的配方更加简单,并且更加的科学合理,设置的镁合金,能够在保持刚性需求的同时,达到被身体降解吸收的作用,通过设置的复合层,能够很好的在初期延迟身体对镁合金的吸收和降解的作用,当复合层被吸收降解之后,镁合金能够快速被身体降解吸收,使用效果好,本发明相比传统技术下设置的冠脉血管支架,使用质量更佳,并且能够很大程度上降低患者的痛苦,减少药物的使用,避免后期的手术次数,利于推广。
具体实施方式
下面将对本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅是本发明一部分实施例,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做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。
实施例一
本发明提供一种技术方案:一种可降解高分子冠脉血管支架,包括:镁合金、复合层、可降解聚酯聚合物和淀粉,其中,镁合金包括有(按质量百分比计):锌16%、硅0.4%、钙1.3%、微量元素2.4%,镁79.9%,复合层包括有(按质量百分比计):加固纤维14%、磷酸三钙17%和琼脂67.5%,水1.5%。
微量元素由硅、钇、锰、铝、铜中的一种或多种组成,可降解聚酯聚合物为聚乙醇酸、聚已内酯、聚己二酸乙二醇酯和聚乳酸-乙 醇酸共聚物,加固纤维为可降解短纤维。
一种可降解高分子冠脉血管支架的制备方法,该血管支架由以下步骤制得:
S1:骨架制作:将锌、硅、钙、微量元素及镁作为原料,一体铸造出骨架和连接件,并且通过连接件合理制作出血管支架主体;
S2:粗糙度处理:将血管支架主体放置在喷涂设备中,将熔融状态下的石蜡通过喷涂设备在血管支架主体的表面进行喷涂,石蜡在血管支架主体表面形成不规则点状凸起,然后将血管支架主体经过酸洗,控制酸洗时间在10s,将血管支架主体拿出,用水洗净;
S3:复合层制取:将琼脂放入到容器中,控制加热时间在20min,缓慢加热溶解,将加固纤维、磷酸三钙依次加入到容器中,搅拌,保温,得到复合层;
S4:将S3步骤中制得的复合层均匀涂抹在血管支架主体上,保持复合层的厚度为0.12mm;
S5:在淀粉中加入水以及可降解聚酯聚合物,搅拌,微热,保持加热温度在35℃以下,搅拌均匀后涂抹在复合层的表面;
S6:将S5步骤中得到的血管支架主体通过镜面处理,至此该可降解高分子冠脉血管支架制备完成。
实施例二
本发明提供一种技术方案:一种可降解高分子冠脉血管支架,包括:镁合金、复合层、可降解聚酯聚合物和淀粉,其中,镁合金包括有(按质量百分比计):锌18%、硅0.5%、钙1.7%、微量元素3%,镁76.8%,复合层包括有(按质量百分比计):加固纤维18%、磷酸三钙16%和琼脂63%,水2%。
微量元素由硅、钇、锰、铝、铜中的一种或多种组成,可降解聚酯聚合物为聚乙醇酸、聚已内酯、聚己二酸乙二醇酯和聚乳酸-乙 醇酸共聚物,加固纤维为可降解短纤维。
一种可降解高分子冠脉血管支架的制备方法,该血管支架由以下步骤制得:
S1:骨架制作:将锌、硅、钙、微量元素及镁作为原料,一体铸造出骨架和连接件,并且通过连接件合理制作出血管支架主体;
S2:粗糙度处理:将血管支架主体放置在喷涂设备中,将熔融状态下的石蜡通过喷涂设备在血管支架主体的表面进行喷涂,石蜡在血管支架主体表面形成不规则点状凸起,然后将血管支架主体经过酸洗,控制酸洗时间在20s,将血管支架主体拿出,用水洗净;
S3:复合层制取:将琼脂放入到容器中,控制加热时间在25min,缓慢加热溶解,将加固纤维、磷酸三钙依次加入到容器中,搅拌,保温,得到复合层;
S4:将S3步骤中制得的复合层均匀涂抹在血管支架主体上,保持复合层的厚度为0.10mm ;
S5:在淀粉中加入水以及可降解聚酯聚合物,搅拌,微热,保持加热温度在35℃以下,搅拌均匀后涂抹在复合层的表面;
S6:将S5步骤中得到的血管支架主体通过镜面处理,至此该可降解高分子冠脉血管支架制备完成。
实施例三
本发明提供一种技术方案:一种可降解高分子冠脉血管支架,包括:镁合金、复合层、可降解聚酯聚合物和淀粉,其中,镁合金包括有(按质量百分比计):锌22%、硅0.6%、钙1.8%、微量元素3.6%,镁72%,复合层包括有(按质量百分比计):加固纤维13%、磷酸三钙18%和琼脂68%,水1%。
微量元素由硅、钇、锰、铝、铜中的一种或多种组成,可降解聚酯聚合物为聚乙醇酸、聚已内酯、聚己二酸乙二醇酯和聚乳酸-乙 醇酸共聚物,加固纤维为可降解短纤维。
一种可降解高分子冠脉血管支架的制备方法,该血管支架由以下步骤制得:
S1:骨架制作:将锌、硅、钙、微量元素及镁作为原料,一体铸造出骨架和连接件,并且通过连接件合理制作出血管支架主体;
S2:粗糙度处理:将血管支架主体放置在喷涂设备中,将熔融状态下的石蜡通过喷涂设备在血管支架主体的表面进行喷涂,石蜡在血管支架主体表面形成不规则点状凸起,然后将血管支架主体经过酸洗,控制酸洗时间在30s,将血管支架主体拿出,用水洗净;
S3:复合层制取:将琼脂放入到容器中,控制加热时间在30min,缓慢加热溶解,将加固纤维、磷酸三钙依次加入到容器中,搅拌,保温,得到复合层;
S4:将S3步骤中制得的复合层均匀涂抹在血管支架主体上,保持复合层的厚度为0.11mm;
S5:在淀粉中加入水以及可降解聚酯聚合物,搅拌,微热,保持加热温度在35℃以下,搅拌均匀后涂抹在复合层的表面;
S6:将S5步骤中得到的血管支架主体通过镜面处理,至此该可降解高分子冠脉血管支架制备完成。
三组实施例均能够制作出可降解高分子冠脉血管支架,并且相比传统的冠脉血管支架,本发明能够实现保持刚性使用需求的同时,能够实现可降解,在进行冠脉血管手术时,能够避免因支架存在导致晚期再狭窄的问题,有身体自行降解和吸收,以镁合金为骨架,在保持基础刚性的同时,能够达到更好和更快的吸收效果,相比传统技术下的血管支架,本发明具有更好的使用效果,应用前景广泛。利于推广。
尽管已经示出和描述了本发明的实施例,对于本领域的普通技术人员而言,可以理解在不脱离本发明的原理和精神的情况下可以对这些实施例进行多种变化、修改、替换和变型,本发明的范围由所附权利要求及其等同物限定。
Claims (8)
1.一种可降解高分子冠脉血管支架,其特征在于,包括:镁合金、复合层、可降解聚酯聚合物和淀粉;
所述镁合金包括有(按质量百分比计):锌15-23%、硅0.3-0.7%、钙1-2%、微量元素2-3.6%,余量为镁;
所述复合层包括有(按质量百分比计):加固纤维12-23%、磷酸三钙15-21%和琼脂61-72%,余量为水。
2.根据权利要求1所述的一种可降解高分子冠脉血管支架,其特征在于:所述镁合金包括有(按质量百分比计):锌16%、硅0.4%、钙1.3%、微量元素2.4%,镁79.9%,所述复合层包括有(按质量百分比计):加固纤维14%、磷酸三钙17%和琼脂67.5%,水1.5%。
3.根据权利要求1所述的一种可降解高分子冠脉血管支架,其特征在于:所述镁合金包括有(按质量百分比计):锌18%、硅0.5%、钙1.7%、微量元素3%,镁76.8%,所述复合层包括有(按质量百分比计):加固纤维18%、磷酸三钙16%和琼脂63%,水2%。
4.根据权利要求1所述的一种可降解高分子冠脉血管支架,其特征在于:所述镁合金包括有(按质量百分比计):锌22%、硅0.6%、钙1.8%、微量元素3.6%,镁72%,所述复合层包括有(按质量百分比计):加固纤维13%、磷酸三钙18%和琼脂68%,水1%。
5.根据权利要求1所述的一种可降解高分子冠脉血管支架,其特征在于:所述微量元素由硅、钇、锰、铝、铜中的一种或多种组成。
6. 根据权利要求1所述的一种可降解高分子冠脉血管支架,其特征在于:所述可降解聚酯聚合物为聚乙醇酸、聚已内酯、聚己二酸乙二醇酯和聚乳酸-乙 醇酸共聚物。
7.根据权利要求1所述的一种可降解高分子冠脉血管支架,其特征在于:所述加固纤维为可降解短纤维。
8.一种如权利要求1-6任意一项所述的可降解高分子冠脉血管支架的制备方法,其特征在于,该血管支架由以下步骤制得:
S1:骨架制作:将锌、硅、钙、微量元素及镁作为原料,一体铸造出骨架和连接件,并且通过连接件合理制作出血管支架主体;
S2:粗糙度处理:将血管支架主体放置在喷涂设备中,将熔融状态下的石蜡通过喷涂设备在血管支架主体的表面进行喷涂,石蜡在血管支架主体表面形成不规则点状凸起,然后将血管支架主体经过酸洗,控制酸洗时间在10-35s之间,将血管支架主体拿出,用水洗净;
S3:复合层制取:将琼脂放入到容器中,控制加热时间在20-35min,缓慢加热溶解,将加固纤维、磷酸三钙依次加入到容器中,搅拌,保温,得到复合层;
S4:将S3步骤中制得的复合层均匀涂抹在血管支架主体上,保持复合层的厚度小于0.13mm;
S5:在淀粉中加入水以及可降解聚酯聚合物,搅拌,微热,保持加热温度在35℃以下,搅拌均匀后涂抹在复合层的表面;
S6:将S5步骤中得到的血管支架主体通过镜面处理,至此该可降解高分子冠脉血管支架制备完成。
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