CN107981954A - 一种3d打印非完全性气管环可嵌入双层pcl慢降解组织工程气管支架及其应用 - Google Patents
一种3d打印非完全性气管环可嵌入双层pcl慢降解组织工程气管支架及其应用 Download PDFInfo
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Abstract
本发明涉及一种PCL慢降解气管支架,由外层支架和内层支架组成,外层支架为镂空的C型圆管,内层支架为镂空圆管,外层支架外表面上设有镂空的C型环,内层支架嵌入外层支架中。本发明还提供慢降解组织工程气管及其应用。其优点表现在:本发明的气管支架从组织结构层次上讲完全仿生,外层为气管软骨,内层为纤毛柱状上皮,既具有气管的韧性又保持了排痰能力,能够减少移植后感染的发生率,且气管环为不完全性,具有生长潜能,可应用于未成年机体。可以制作成任意直径,能够满足个体化的需求。PCL支架可以在体内完全降解且降解缓慢,对机体无毒害。
Description
技术领域
本发明涉及医疗器械技术领域,具体地说,是一种慢降解组织工程气管支架及其应用。
背景技术
目前,现有的组织工程3D打印聚己内酯(PCL)支架为完全性气管环,且为单层,只见表面仅能种植气管软骨细胞,该种支架为完全性气管环,缺乏生长潜力,且由于未能种植纤毛柱状上皮细胞,故没有排痰能力,移植术后易于发生感染,导致气管移植失败。
气管是一种由透明软骨、上皮组织、结缔组织等构成的复杂器官,其中软骨环起支撑作用,上皮组织起清洁及防御功能。基于气管的这种解剖和生理特点,构建具备完整结构与功能的组织工程气管非常有必要。
本发明通过3D打印技术分别构建外层带非完全性气管环的PCL支架,以及内层PCL支架,两层支架分别种植气管软骨细胞以及纤毛柱状上皮细胞,并可将内层支架插入带非完全性气管环的外层支架,从而构建完全符合生理架构的组织工程气管支架。
中国专利文献CN105055060A公开了一种气管支架,设有支撑环和支撑连杆,各个所述的支撑环为C型,各个支撑环由支撑连杆串联连接,使得各个支撑环和支撑连杆固定成一体。但其仅为单层。中国专利文献CN105853022A公开了一种气管支架,包括多个间隔设置的支撑环,相邻所述支撑环之间设置有中空的网状的支撑件。但其仅为单层。中国专利文献CN107174384A公开了一种3D打印气管支架,包括内层支架和外层支架;所述的内层支架和外层支架均设置为圆环状支架,且所述的外层支架的外径大于内层支架,而所述的内层支架的厚度则大于外层支架,且所述的内层支架与外层支架之间通过均匀分布的支撑杆相连;所述的内层支架的中心处设置为中心气管。但是关于本发明的一种3D打印非完全性气管环可嵌入双层PCL慢降解组织工程气管支架及其应用目前还未见报道。
发明内容
本发明的第一个目的是,针对现有技术中的不足,提供一种慢降解气管支架。
本发明的第二个目的是,提供一种慢降解气管支架的应用。
本发明的第三个目的是,提供一种慢降解组织工程气管。
本发明的第四个目的是,提供一种慢降解组织工程气管的应用。
为实现上述第一个目的,本发明采取的技术方案是:一种慢降解气管支架,所述的慢降解气管支架的材料为聚己内酯,所述的慢降解气管支架由外层支架和内层支架组成,外层支架为镂空的C型圆管,内层支架为镂空圆管,外层支架外表面上设有镂空的C型环,内层支架嵌入外层支架中。
进一步地,所述的外层支架的内径比所述的内层支架的外径大0.1mm。
进一步地,所述的外层支架的内径为5.1mm。
进一步地,所述的外层支架的C型缺口长度为3mm。
进一步地,所述的C型环之间的间隔为1.5mm,所述的C型环的高度为 1.5mm。
为实现上述第二个目的,本发明采取的技术方案是:前述慢降解气管支架在制备组织工程气管中的应用。
为实现上述第三个目的,本发明采取的技术方案是:一种慢降解组织工程气管,由前述慢降解气管支架制成,外层支架种植气管软骨细胞,内层支架种植纤毛柱状上皮细胞。
进一步地,所述的慢降解组织工程气管的制备方法包括如下步骤:(1)外层支架表面种植气管软骨细胞,内层支架内表面种植纤毛柱状上皮细胞;(2) 将外层支架和内层支架埋入皮下,待细胞成熟后取出,并将内层支架嵌入外层支架中。
进一步地,所述的步骤(2)为:将外层支架和内层支架埋入裸鼠皮下3~4 周,待细胞成熟后取出,并将内层支架嵌入外层支架中。
为实现上述第四个目的,本发明采取的技术方案是:前述慢降解组织工程气管在制备人工气管的医疗器械中的应用。
本发明优点在于:
1、从组织结构层次上讲完全仿生,外层为气管软骨,内层为纤毛柱状上皮,既具有气管的韧性又保持了排痰能力,能够减少移植后感染的发生率,且气管环为不完全性,具有生长潜能,可应用于未成年机体。
2、本发明利用3D打印技术可以顺利解决气管支架构建困难的问题,且可以制作成任意直径,能够满足个体化的需求。
3、本发明的材质为PCL,PCL支架可以在体内完全降解且降解缓慢,对机体无毒害。
附图说明
附图1是一种慢降解气管支架的结构示意图。
附图2是一种慢降解气管支架的俯视示意图。
附图3是外层支架的结构示意图。
附图4是内层支架的结构示意图。
附图5是一种慢降解气管支架的结构示意图。
具体实施方式
下面结合实施例对本发明提供的具体实施方式作详细说明。
附图中涉及的附图标记和组成部分如下所示:
1、外层支架
11、C型环
12、圆环
2、内层支架
实施例1:慢降解气管支架
请参照附图1-4,附图1是一种慢降解气管支架的结构示意图,附图2是一种慢降解气管支架的俯视示意图,附图3是外层支架的结构示意图,附图4 是内层支架的结构示意图。
所述的慢降解气管支架由外层支架1和内层支架2组成,所述的外层支架 1为镂空的C型圆管,所述的内层支架2为镂空圆管,所述的外层支架1外表面上设有镂空的C型环11,所述的内层支架2嵌入所述的外层支架1中。
所述的慢降解气管支架可采用包括但不限于PCL的可在人体内慢速降解的材料。PCL材料生物相容性好,可在人体内完全降解,并且降解缓慢,对机体无毒害。
所述的内层支架2可根据不同个体需求,设计成任意合适的直径。
需要说明的是,外层支架1、C型环11设计为C型,所述的“C型”包括与字母“C”相同或相似的形状、圆弧形和其他弧形,其与人体正常气管环(不完全性气管环)的形状是相同或者相似的。本发明将该环设计为C型,符合人体的生理架构,具有生长潜能。
本发明的气管支架设计为双层结构,不同于现有技术中的单层结构,不仅可以种植气管软骨细胞,还可种植纤毛柱状上皮细胞,既具有气管的韧性又保持了排痰能力,能够减少移植后感染的发生率。且为气管环为不完全性,具有生长潜能,可应用于未成年机体。
实施例2:慢降解气管支架
请参照附图1-4,附图1是一种慢降解气管支架的结构示意图,附图2是一种慢降解气管支架的俯视示意图,附图3是外层支架的结构示意图,附图4 是内层支架的结构示意图。
所述的慢降解气管支架的材料为PCL,所述的慢降解气管支架由外层支架 1和内层支架2组成,所述的外层支架1为网状C型圆管,所述的内层支架2 为网状圆管,所述的外层支架1外表面上设有镂空的C型环11,所述的内层支架2嵌入所述的外层支架1中。所述的外层支架1的内径为5.1mm,外层支架1的C型缺口长度为3mm。所述的内层支架2的外径为5mm,所述的内层支架2的内径为4.5mm。所述的C型环11的高度为1.5mm,C型环11径向厚度为1.5mm,相邻C型环11之间的平均距离为3mm,即相邻C型环11之间的间隔为1.5mm。
实施例3:慢降解气管支架
请参照附图5,附图5是一种慢降解气管支架的结构示意图。
所述的慢降解气管支架的材料为PCL,所述的慢降解气管支架由外层支架 1和内层支架2组成,所述的外层支架1为镂空的C型圆管,所述的内层支架2为镂空圆管,所述的外层支架1外表面上设有镂空的C型环11,所述的外层支架1的上缘和下缘为圆环12,所述的内层支架2嵌入所述的外层支架1中。所述的外层支架1的内径为5.1mm,外层支架1的C型缺口长度为3mm。所述的内层支架2的外径为5mm,所述的内层支架2的内径为4.5mm。所述的C 型环11的高度为1.5mm,C型环11径向厚度为1.5mm,相邻C型环11之间的平均距离为3mm,即相邻C型环11之间的间隔为1.5mm。
实施例4:慢降解组织工程气管
在实施例1的慢降解气管支架的基础上通过如下步骤制备:
(1)外层支架1表面种植气管软骨细胞,内层支架2内表面种植纤毛柱状上皮细胞。
(2)将外层支架1和内层支架2埋入裸鼠皮下3~4周,待细胞成熟后取出,并将内层支架2嵌入外层支架1中。
实施例5:3D打印技术
本发明可根据患者的CT等影像资料设计并采用3D打印技术制作合适尺寸的慢降解气管支架,通过3D打印技术将PCL材料制作成合适形状在本技术领域是已知的。本发明的慢降解气管支架可通过3D打印技术分别构建外层支架1和内层支架2。
例如,将PCL溶于三氟乙醇中,搅拌至完全溶解,得到透明的PCL纺丝液,通过3D打印机将PCL纺丝液通过静电纺丝装置电纺,真空干燥去除残留有机溶剂即可。
以上所述仅是本发明的优选实施方式,应当指出,对于本技术领域的普通技术人员,在不脱离本发明方法的前提下,还可以做出若干改进和补充,这些改进和补充也应视为本发明的保护范围。
Claims (10)
1.一种慢降解气管支架,其特征在于,所述的慢降解气管支架的材料为聚己内酯,所述的慢降解气管支架由外层支架和内层支架组成,外层支架为镂空的C型圆管,内层支架为镂空圆管,外层支架外表面上设有镂空的C型环,内层支架嵌入外层支架中。
2.根据权利要求1所述的慢降解气管支架,其特征在于,所述的外层支架的内径比所述的内层支架的外径大0.1mm。
3.根据权利要求1所述的慢降解气管支架,其特征在于,所述的外层支架的内径为5.1mm。
4.根据权利要求1所述的慢降解气管支架,其特征在于,所述的外层支架的C型缺口长度为3mm。
5.根据权利要求1所述的慢降解气管支架,其特征在于,所述的C型环之间的间隔为1.5mm,所述的C型环的高度为1.5mm。
6.根据权利要求1-5任一所述的慢降解气管支架在制备组织工程气管中的应用。
7.一种慢降解组织工程气管,其特征在于,所述的慢降解组织工程气管由权利要求1-5任一所述的慢降解气管支架制成,外层支架种植气管软骨细胞,内层支架种植纤毛柱状上皮细胞。
8.根据权利要求7所述的慢降解组织工程气管,其特征在于,所述的慢降解组织工程气管的制备方法包括如下步骤:(1)外层支架表面种植气管软骨细胞,内层支架内表面种植纤毛柱状上皮细胞;(2)将外层支架和内层支架埋入皮下,待细胞成熟后取出,并将内层支架嵌入外层支架中。
9.根据权利要求8所述的慢降解组织工程气管,其特征在于,所述的步骤(2)为:将外层支架和内层支架埋入裸鼠皮下3~4周,待细胞成熟后取出,并将内层支架嵌入外层支架中。
10.根据权利要求7~9任一所述的慢降解组织工程气管在制备人工气管的医疗器械中的应用。
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