CN109395174B - 防瘢痕可降解气管支架的制备方法及其产品 - Google Patents
防瘢痕可降解气管支架的制备方法及其产品 Download PDFInfo
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Abstract
本发明提供一种用于喉气管手术中的防瘢痕可降解的气管支架,属于医疗器械制备及加工的应用领域,其制备过程是以PTMG,HDI和PEG混合熔融制得预聚体,将预聚体溶解并加入乙酰柠檬酸三丁酯和不同浓度的氟尿嘧啶,通过熔融挤出3D打印法制备气管支架。该气管支架的组成材料为生物弹性体,生物相容性好,且可降解,对环境友好。由于其中掺入了氟尿嘧啶,可做到体内应用时缓释药物,具有防瘢痕的效果。使用3D打印技术来制备,具有特异性,可以根据不同病人气管构造的差异性来调整。
Description
技术领域
本发明涉及一种防瘢痕可降解气管支架的制备方法及其产品,属于医疗器械制备及加工的应用领域。
技术背景
喉气管狭窄一直是临床医学难题之一。导致喉气管狭窄的原因复杂,外伤,特殊感染,先天性疾病等都可能导致喉气管狭窄。而其中,外伤导致的,尤其是置入气管支架导致瘢痕组织增生形成的气管狭窄,是气管手术甚至是治疗气管狭窄本身最可能发生的后遗症,而其治疗起来却非常棘手,因此气管手术患者愈后常常遭受着一定程度的呼吸困难,进食咳呛甚至其他全身性症状,对生活质量产生极大影响。
对于抢救呼吸功能障碍患者,气管插管最重要的一种手段,而对于预防气管插管引起的瘢痕性气管狭窄,在临床治疗中主要有手术治疗和药物治疗,手术治疗包括球囊扩充,支架置入,喉气管重建术等,手术治疗可迅速解除呼吸困难,缓解临床症状,但手术治疗创伤性较高,和插管一样易导致瘢痕性增生。药物治疗创伤小,操作方便。常用的治疗气管狭窄的药物有丝裂霉素,氟尿嘧啶,甲壳素,壳聚糖及其衍生物等。其中,氟尿嘧啶已被广泛应用于病理性瘢痕的治疗,它是一种传统的抗肿瘤药物,通过抑制细胞的DNA合成,掺入RNA干扰蛋白质的合成来抑制细胞增殖和胶原蛋白过度表达,治疗瘢痕效果较好。
生物弹性体是指具有生物相容性,在人体温度范围(35~40℃)伸长率通常可达150%以上,除去外力后又可基本恢复到原长的高分子物质,可应用于诊断,治疗,组织修复,功能增强等临床领域。聚氨酯材料具有优异的力学强度,高弹耐磨,生物相容性好等优点,因而在需要长期植入的医用装置中有着广泛的应用。
熔融挤出3D打印技术通过将生物相容性的天然高分子或合成高分子等溶解在特定的溶剂中,通过加工头的加热挤压,在计算机的控制下挤出材料逐层堆积,最终得到成形的立体零件,这种成型方法维护简单,成本较低,是目前常见应用的3D打印技术。
发明内容
针对现有技术的不足,本发明目的在于提供一种防瘢痕可降解气管支架的制备方法。
本发明的再一目的在于:提供一种上述方法制备的防瘢痕可降解气管支架产品。
本发明的又一目的在于:提供一种上述产品的应用。
本发明目的通过下述方案实现:一种防瘢痕可降解气管支架的制备方法,其特征在于,包含以下步骤:
(1)气管支架预聚体的制备;
(2)预聚体和PEG的混合:
将挤出机升温至100℃预热30min,然后升温至140℃,调整转速为100r/min,依次序加入预聚体和PEG,二者质量比为10:1,挤出共混材料;
(3)预聚体和增塑剂,氟尿嘧啶的混合:
将挤出的共混材料溶解后加入1%乙酰柠檬酸三丁酯作为增塑剂,并添加浓度为0.01-0.2%的氟尿嘧啶,然后干燥除掉溶剂,制备不同含量氟尿嘧啶的打印原料;
(4)气管支架的建模及打印:
将打印原料剪成小块,混合后投入3D plotter的打印腔体内,升温至180℃并预热10min,压力设置为4bar,调整合适的挤出速度打印得到防瘢痕可降解气管支架。打印的支架形状也可以根据每个病人的生理构造做一些调整。
本发明机理是:以PTMG,HDI和PEG共混后制备的生物弹性体为主体结构材料作为力学支撑的主要成分,填料过程中掺入乙酰柠檬酸三丁酯和纳米粒度的氟尿嘧啶,然后通过熔融挤出成型3D打印法制备防瘢痕可降解气管支架。
所述步骤(1)中具体为:称取20g 聚四氢呋喃二醇(PTMG)2000于烧瓶中在110℃下真空干燥2h后,加入1,6-六甲基二异氰酸酯(HDI)3.625g,70℃预聚250min,搅拌速率60rpm,催化剂辛酸亚锡(SnOct2)浓度分数0.1%,氮气保护下制得预聚体。
所述步骤(2)中将预聚体和PEG剪成小块,在鼓风干燥箱50℃干燥5h,作为挤出共混备用料。
所述步骤(2)中预聚体和PEG的挤出共混循环三次确保混合均匀。
所述步骤(3)中氟尿嘧啶的浓度0.01-0.2%。
本发明提供一种防瘢痕可降解气管支架,根据上述任一所述方法制备得到。
气管支架为管壁镂空的圆形管状,直径为10~13mm,气管支架的长度可根据所需长度进行调节,为15~35mm;壁厚为1.5~3mm。
其管壁镂空为六边形孔洞,利于细胞粘附;六边形孔洞每边为2.5~3mm,所形成的孔壁为1.5~2mm。
本发明还提供一种防瘢痕可降解气管支架在喉气管手术中的应用。
本发明旨在提供一种含氟尿嘧啶的具有防瘢痕功能,且主体材料为生物弹性体的医用可降解气管支架,通过将氟尿嘧啶掺入到气管支架打印填料中,利用熔融挤出3D打印制备,此支架可有效减少因长期体内留置导致的气管瘢痕增生症状,且生物可降解,对环境友好,制备过程简便。
本发明的制备方法为熔融挤出3D打印法,所用仪器为3D plotter打印机。
本发明的优点在于:
1. 气管支架的材料为生物弹性体材料,生物相容性好。
2. 气管支架中掺入氟尿嘧啶,在体内应用时可缓释,具有防瘢痕功能且效果持久。
3. 气管支架可降解,对环境友好。
4. 制备方法为熔融挤出3D打印法,只需要将原料混合熔融之后加入打印机即可,非常简便且易定制,可根据病人身体构造差异来调整插管形状。
附图说明
附图1为气管支架的俯视图;
附图2为气管支架的主视图;
附图3为气管支架的左视图;
附图4为气管支架的立体视图。
具体实施方式
实施例1
一种防瘢痕可降解气管支架,按以下步骤制备:
(1)气管支架预聚体的制备:
称取20g PTMG于烧瓶中在110℃下真空干燥2h后,加入HDI3.625g,,70℃预聚250min,搅拌速率60rpm,催化剂辛酸亚锡(SnOct2)浓度分数0.1%,氮气保护。
(2)预聚体和PEG的混合:
将聚氨酯和PEG剪成小块,在鼓风干燥箱50℃干燥5h备用;将挤出机升温至100℃预热30min,然后升温至140℃,调整转速为100r/min,依次序加入预聚体和PEG,二者质量比为10:1,挤出共混材料,共混挤出工序循环三次确保混合均匀;
(3)预聚体和增塑剂,氟尿嘧啶的混合:
将挤出的共混材料溶解后加入1%乙酰柠檬酸三丁酯作为增塑剂,并添加浓度为0.01的氟尿嘧啶,然后干燥除掉溶剂,制备不同含量氟尿嘧啶的打印原料;
(4)气管支架的建模及打印:
将打印原料剪成小块,混合后塞进3D plotter的打印腔体内,升温至180℃并预热10min,压力设置为4bar,调整合适的挤出速度打印得到防瘢痕可降解气管支架。
防瘢痕可降解气管支架形状如图附图1为气管支架的俯视图、附图2为气管支架的主视图、附图3为气管支架的左视图和附图4为气管支架的立体视图所示,气管支架直径为10mm,其管壁镂空为六边形孔洞,利于细胞粘附。六边形孔洞每边为2.8mm,所形成的孔壁约为1.5mm。气管支架的长度可根据所需长度进行调节,可为15~35mm。
实施例2
一种防瘢痕可降解气管支架,按以下步骤制备:
(1)气管支架预聚体的制备:
称取20g PTMG于烧瓶中在110℃下真空干燥2h后,加入HDI3.625g,,70℃预聚250min,搅拌速率60rpm,催化剂辛酸亚锡(SnOct2)浓度分数0.1%,氮气保护,得聚氨酯。
(2)预聚体和PEG的混合:
将聚氨酯和PEG剪成小块,在鼓风干燥箱50℃干燥5h备用。将聚合物挤出机升温至100℃预热30min,然后升温至140℃,调整转速为100r/min,依次序加入预聚体和PEG,二者质量比为10:1,挤出共混材料。循环三次确保混合均匀。
(3)预聚体和增塑剂,氟尿嘧啶的混合:
将挤出的共混物溶解后加入1%乙酰柠檬酸三丁酯作为增塑剂,并添加0.05%的氟尿嘧啶,然后干燥除掉溶剂,制备不同含量氟尿嘧啶的打印原料。
(4)气管支架的建模及打印:
将打印原料剪成小块,混合后塞进3D plotter的打印腔体内,升温至180℃并预热10min,压力设置为4bar,调整合适的挤出速度开始打印。
气管支架直径为12mm,其管壁镂空为六边形孔洞,利于细胞粘附。六边形孔洞每边为3mm,所形成的孔壁约为2mm。气管支架的长度可根据所需长度进行调节,可为15~35mm。
实施例3
一种防瘢痕可降解气管支架,按以下步骤制备:
(1)气管支架预聚体的制备:
称取20g PTMG于烧瓶中在110℃下真空干燥2h后,加入HDI3.625g,,70℃预聚250min,搅拌速率60rpm,催化剂辛酸亚锡(SnOct2)浓度分数0.1%,氮气保护,得聚氨酯。
(2)预聚体和PEG的混合:
将聚氨酯和PEG剪成小块,在鼓风干燥箱50℃干燥5h备用。将聚合物挤出机升温至100℃预热30min,然后升温至140℃,调整转速为100r/min,依次序加入预聚体和PEG,二者质量比为10:1,挤出共混材料。循环三次确保混合均匀。
(3)预聚体和增塑剂,氟尿嘧啶的混合:
将挤出的共混物溶解后加入1%乙酰柠檬酸三丁酯作为增塑剂,并添加0.1%的氟尿嘧啶,然后干燥除掉溶剂,制备不同含量氟尿嘧啶的打印原料。
(4)气管支架的建模及打印:
将打印原料剪成小块,混合后塞进3D plotter的打印腔体内,升温至180℃并预热10min,压力设置为4bar,调整合适的挤出速度开始打印。
气管支架直径为11mm,其管壁镂空为六边形孔洞,利于细胞粘附。六边形孔洞每边为2.9mm,所形成的孔壁约为1.75mm。气管支架的长度可根据所需长度进行调节,可为15~35mm。
实施例4
一种防瘢痕可降解气管支架,按以下步骤制备:
(1)气管支架预聚体的制备:
称取20g PTMG于烧瓶中在110℃下真空干燥2h后,加入HDI3.625g,,70℃预聚250min,搅拌速率60rpm,催化剂辛酸亚锡(SnOct2)浓度分数0.1%,氮气保护,得聚氨酯。
(2)预聚体和PEG的混合:
将聚氨酯和PEG剪成小块,在鼓风干燥箱50℃干燥5h备用。将聚合物挤出机升温至100℃预热30min,然后升温至140℃,调整转速为100r/min,依次序加入预聚体和PEG,二者质量比为10:1,挤出共混材料。循环三次确保混合均匀。
(3)预聚体和增塑剂,氟尿嘧啶的混合:
将挤出的共混物溶解后加入1%乙酰柠檬酸三丁酯作为增塑剂,并添加0.2%的氟尿嘧啶,然后干燥除掉溶剂,制备不同含量氟尿嘧啶的打印原料。
(4)气管支架的建模及打印:
将打印原料剪成小块,混合后塞进3D plotter的打印腔体内,升温至180℃并预热10min,压力设置为4bar,调整合适的挤出速度开始打印。
气管支架直径为13mm,其管壁镂空为六边形孔洞,利于细胞粘附。六边形孔洞每边为2.5mm,所形成的孔壁约为1.8mm。气管支架的长度可根据所需长度进行调节,可为15~35mm。
Claims (5)
1.一种防瘢痕可降解气管支架的制备方法,其特征在于,所述气管支架为管壁镂空的圆形管状,直径为10-13mm,气管支架的长度可根据所需长度进行调节,为15-35mm;其管壁镂空为六边形孔洞,利于细胞粘附;六边形孔洞每边为2.5-3mm,所形成的孔壁为1.5-2mm;包含以下制备步骤:
(1)气管支架预聚体的制备;
(2)预聚体和PEG的混合:
将挤出机升温至100℃预热30min,然后升温至140℃,调整转速为100r/min,依次序加入预聚体和PEG,二者质量比为10:1,挤出共混材料;
(3)预聚体和增塑剂,氟尿嘧啶的混合:
将挤出的共混材料溶解后加入1%乙酰柠檬酸三丁酯作为增塑剂,并添加浓度为0.01-0.2%的氟尿嘧啶,然后干燥除掉溶剂,制备不同含量氟尿嘧啶的打印原料;
(4)气管支架的建模及打印:
将打印原料剪成小块,混合后投入3D plotter的打印腔体内,升温至180℃并预热10min,压力设置为4bar,调整合适的挤出速度打印得到防瘢痕可降解气管支架;其中,
所述步骤(1)中所述气管支架预聚体按下述步骤制备:称取20g 聚四氢呋喃二醇2000于烧瓶中在110℃下真空干燥2h后,加入1,6-六甲基二异氰酸酯3.625g,70℃预聚250min,搅拌速率60rpm,催化剂辛酸亚锡浓度分数0.1%,氮气保护下制得预聚体。
2.根据权利要求1所述防瘢痕可降解气管支架的制备方法,其特征在于:所述步骤(2)中,将预聚体和PEG剪成小块,在鼓风干燥箱50℃干燥5h,得挤出共混备用料。
3.根据权利要求2所述防瘢痕可降解气管支架的制备方法,其特征在于:所述步骤(2)中预聚体和PEG挤出共混循环三次确保混合均匀。
4.一种防瘢痕可降解气管支架,其特征在于根据权利要求1-3任一所述方法制备得到。
5.一种根据权利要求4所述防瘢痕可降解气管支架在制备喉气管手术材料中的应用。
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