CN113046860A - 一种聚己内酯纤维及其双层血管再生支架的制备方法 - Google Patents

一种聚己内酯纤维及其双层血管再生支架的制备方法 Download PDF

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CN113046860A
CN113046860A CN201911372565.1A CN201911372565A CN113046860A CN 113046860 A CN113046860 A CN 113046860A CN 201911372565 A CN201911372565 A CN 201911372565A CN 113046860 A CN113046860 A CN 113046860A
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Abstract

本发明所述聚己内酯纤维及其双层血管再生支架的制备方法，属于血管支架领域，其特征在于：通过静电纺丝溶液的配制备；静电纺丝；乙醇处理；泡水处理；冷冻干燥所制的聚己内酯纤维及其双层血管再生支架，内层纤维分布均匀，孔隙相对较小，可在一定程度上降低血液渗透性，为内皮细胞提供更多的黏附位点，加快内皮层的形成，而外层纤维网孔隙较大，能够引导平滑肌细胞的迁入，从而形成有功能性分区的血管支架。

Description

一种聚己内酯纤维及其双层血管再生支架的制备方法
技术领域
本发明属于血管支架领域，尤其涉及一种聚己内酯纤维及其双层血管再生支架的制备方法。
背景技术
动脉硬化、栓塞、老化以及破损等血管疾病是世界范围内致死率极高的疾病。据世界卫生组织估计，2013年全球大约有1700万人死于心脑血管疾病，其中发展中国家占到80%。中国心血管病报告显示，我国心脑血管疾病患者有2.3亿，每年死于心脑血管疾病的人数约为350万，占各类疾病死因的 41%。
血管移植手术是血管疾病治疗的一个重要手段。目前，临床使用的血管移植物主要包括自体血管及非降解性合成材料管两类。尽管自体血管替换病变血管的术后效果满意，但却由于来源有限和供区创伤等原因难以满足临床需求。
发明内容
本发明旨在解决上述问题，提供一种聚己内酯纤维及其双层血管再生支架的制备方法。
本发明所述聚己内酯纤维及其双层血管再生支架的制备方法，包括如下步骤：
（1）静电纺丝溶液的配制备；将SF多孔材料以HFIP为溶剂，配成浓度 9 %的溶液，用保鲜膜密封后，充分搅拌后静置除去气泡后室温保存备用；
将 PCL 加入到 HFIP：CH2Cl2以8:2的比例混合溶剂中，磁力搅拌器搅拌使其混合均匀，配成浓度为 7%的纺丝溶液，静置除去气泡后室温保存备用；
PEO 溶于 HFIP 中配置浓度为 10%的溶液，用保鲜膜密封后充分搅拌并静置除去气泡后室温保存备用；
（2）静电纺丝；采用同轴静电纺丝技术纺丝，使纤维具备皮/芯结构，其中皮层为SF，芯层为PCL；该技术有两套供液系统，分别控制SF溶液和PCL 溶液的送液速率；纺丝喷头为自制的同轴针头，设置皮层 SF 溶液推进速度为 1.8 mL/h；芯层 PCL 溶液的推进速度为0.6 mL/h；纺丝距离为 12 cm；纺丝电压约在 12 kV；PEO 溶液采用单喷头静电纺丝技术单独纺丝，设置送液速率2.4mL/h，纺丝距离为12cm，纺丝电压为 12 kV；两种静电纺丝的喷丝头都固定在横动装置上，以 5 mm/min 的横动速度来回移动，横动距离 5 cm。
（3）乙醇处理将制备的管状支架连同接收的金属棒一起放入80%的乙醇浸泡2 h；
（4）泡水处理；管状支架连同金属棒经乙醇处理后，共同放入到 50 ℃的水中，并在摇床上震荡6 h，期间每 1 h 换水一次；
（5）冷冻干燥；经泡水后，管状支架连同金属棒一起放入冷冻干燥机-50 ℃冷冻干燥 2天，然后将管状支架从金属棒上取下备用。
进一步，本发明所述聚己内酯纤维及其双层血管再生支架的制备方法，所述管状支架的制备采用的接收方式：首先，用直径为1mm的金属棒作为接收装置接收 C-SF/PCL 纤维，金属棒外绕有直径为0.5mm金属铜丝，转速设为1000rpm；分别1h和2h 后，辅以引导电极后同时接收 C-SF/PCL和PEO纤维3h和2h，静电纺纤维卷绕在金属转轴上，形成管状支架。
进一步，本发明所述聚己内酯纤维及其双层血管再生支架的制备方法，所述纺丝喷头的喷丝头的内外同轴喷丝头的内直径分别是0.3与1.2 mm。
本发明所述聚己内酯纤维及其双层血管再生支架的制备方法，所制备的聚己内酯纤维及其双层血管再生支架，模拟 ECM 的拓扑结构，其中，内层纤维分布均匀，孔隙相对较小，可在一定程度上降低血液渗透性，为内皮细胞提供更多的黏附位点，加快内皮层的形成，而外层纤维网孔隙较大，能够引导平滑肌细胞的迁入，从而形成有功能性分区的血管支架。
具体实施方式
下面通过实施例对本发明所述聚己内酯纤维及其双层血管再生支架的制备方法进行详细说明。
本发明所述聚己内酯纤维及其双层血管再生支架的制备方法，包括如下步骤：
（1）静电纺丝溶液的配制备；将SF多孔材料以HFIP为溶剂，配成浓度 9 %的溶液，用保鲜膜密封后，充分搅拌后静置除去气泡后室温保存备用；
将 PCL 加入到 HFIP：CH2Cl2以8:2的比例混合溶剂中，磁力搅拌器搅拌使其混合均匀，配成浓度为 7%的纺丝溶液，静置除去气泡后室温保存备用；
PEO 溶于 HFIP 中配置浓度为 10%的溶液，用保鲜膜密封后充分搅拌并静置除去气泡后室温保存备用；
（2）静电纺丝；采用同轴静电纺丝技术纺丝，使纤维具备皮/芯结构，其中皮层为SF，芯层为PCL；该技术有两套供液系统，分别控制SF溶液和PCL 溶液的送液速率；纺丝喷头为自制的同轴针头，设置皮层 SF 溶液推进速度为 1.8 mL/h；芯层 PCL 溶液的推进速度为0.6 mL/h；纺丝距离为 12 cm；纺丝电压约在 12 kV；PEO 溶液采用单喷头静电纺丝技术单独纺丝，设置送液速率2.4mL/h，纺丝距离为12cm，纺丝电压为 12 kV；两种静电纺丝的喷丝头都固定在横动装置上，以 5 mm/min 的横动速度来回移动，横动距离 5 cm。
（3）乙醇处理将制备的管状支架连同接收的金属棒一起放入80%的乙醇浸泡2 h；
（4）泡水处理；管状支架连同金属棒经乙醇处理后，共同放入到 50 ℃的水中，并在摇床上震荡6 h，期间每 1 h 换水一次；
（5）冷冻干燥；经泡水后，管状支架连同金属棒一起放入冷冻干燥机-50 ℃冷冻干燥 2天，然后将管状支架从金属棒上取下备用。
本发明所述聚己内酯纤维及其双层血管再生支架的制备方法，所述管状支架的制备采用的接收方式：首先，用直径为1mm的金属棒作为接收装置接收 C-SF/PCL 纤维，金属棒外绕有直径为0.5mm金属铜丝，转速设为1000rpm；分别1h和2h 后，辅以引导电极后同时接收 C-SF/PCL和PEO纤维3h和2h，静电纺纤维卷绕在金属转轴上，形成管状支架。在本实施例中所述纺丝喷头的喷丝头的内外同轴喷丝头的内直径分别是0.3与1.2 mm。
作为小口径血管再生支架材料，应具有良好的力学性能，才能够满足细胞生长和材料的使用要求。静电纺纤维支架的力学性能主要依靠纤维的几何结构、材料的力学性质及材料间的相互作用来决定的。
本实施例所制备的双层小口径血管支架的整体、表面、截面及表面的形貌。管状支架成型良好，支架内径约为 2mm，壁厚约为 650μm，由疏密排列的两层纤维组成，其中内层厚度约为200μm，为紧密、均匀、无序排列的纤维，外层厚度约为 450μm，由疏松、均匀、定向排列的纤维组成。
双层纤维支架在拉伸断裂过程中曲线的变化规律相似，都存在明显的两个峰值，说明支架的双层纤维会不同时断裂，其中第一个峰值表示支架的外层先断裂，第二个峰值表示支架的内层断裂，支架的外层先于内层断裂。其原因是：双层支架的内层纤维随机排列，受拉伸过程中纤维先伸直趋向周向排列，然后再伸长直至断裂；而外层纤维多数为沿着周向排列，纤维直接伸直直至断裂，因此两层在拉伸至断裂的过程中的伸长不同，从而存在支架两层的断裂不同时性。
血管支架必须具备足够的拉伸强度与断裂伸长率以承受人体血液的流动对管壁产生的剪切作用。内层纺 1 h 的双层血管支架的径向拉伸强度明显大于单层血管支架，双层血管支架的轴向强度度显著小于单层血管支架。内层纺 1 h 的双层支架的径向断裂伸长率小于单层血管支架，而两者的轴向断裂伸长率无明显差异。内层纺 1 h的双层支架的径向弹性模量大于无序纤维支架，而轴向弹性模量相似。以上数据说明：随着外层厚度的增加，支架的径向强力增加，取向的纤维结构增强了支架径向强度，也增大了支架的径向弹性模量。

Claims (3)

1.一种聚己内酯纤维及其双层血管再生支架的制备方法，其特征在于包括如下步骤：
（1）静电纺丝溶液的配制备；将SF多孔材料以HFIP为溶剂，配成浓度 9 %的溶液，用保鲜膜密封后，充分搅拌后静置除去气泡后室温保存备用；
将 PCL 加入到 HFIP：CH2Cl2以8:2的比例混合溶剂中，磁力搅拌器搅拌使其混合均匀，配成浓度为 7%的纺丝溶液，静置除去气泡后室温保存备用；
PEO 溶于 HFIP 中配置浓度为 10%的溶液，用保鲜膜密封后充分搅拌并静置除去气泡后室温保存备用；
（2）静电纺丝；采用同轴静电纺丝技术纺丝，使纤维具备皮/芯结构，其中皮层为SF，芯层为PCL；该技术有两套供液系统，分别控制SF溶液和PCL 溶液的送液速率；纺丝喷头为自制的同轴针头，设置皮层 SF 溶液推进速度为 1.8 mL/h；芯层 PCL 溶液的推进速度为0.6 mL/h；纺丝距离为 12 cm；纺丝电压约在 12 kV；
PEO 溶液采用单喷头静电纺丝技术单独纺丝，设置送液速率2.4mL/h，纺丝距离为12cm，纺丝电压为 12 kV；
两种静电纺丝的喷丝头都固定在横动装置上，以 5 mm/min 的横动速度来回移
动，横动距离 5 cm；
（3）乙醇处理将制备的管状支架连同接收的金属棒一起放入80%的乙醇浸泡2 h；
（4）泡水处理；管状支架连同金属棒经乙醇处理后，共同放入到 50 ℃的水中，并在摇床上震荡6 h，期间每 1 h 换水一次；
（5）冷冻干燥；经泡水后，管状支架连同金属棒一起放入冷冻干燥机-50 ℃冷冻干燥 2天，然后将管状支架从金属棒上取下备用。
2. 根据权利要求1所述聚己内酯纤维及其双层血管再生支架的制备方法，其特征在于：所述管状支架的制备采用的接收方式：首先，用直径为1mm的金属棒作为接收装置接收C-SF/PCL 纤维，金属棒外绕有直径为0.5mm金属铜丝，转速设为1000rpm；分别1h和2h 后，辅以引导电极后同时接收 C-SF/PCL和PEO纤维3h和2h，静电纺纤维卷绕在金属转轴上，形成管状支架。
3. 根据权利要求2所述聚己内酯纤维及其双层血管再生支架的制备方法，其特征在于：所述纺丝喷头的喷丝头的内外同轴喷丝头的内直径分别是0.3与1.2 mm。
CN201911372565.1A 2019-12-27 2019-12-27 一种聚己内酯纤维及其双层血管再生支架的制备方法 Pending CN113046860A (zh)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117339013A (zh) * 2023-12-04 2024-01-05 山东百多安医疗器械股份有限公司 一种能提高软骨修复能力的水凝胶复合支架

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117339013A (zh) * 2023-12-04 2024-01-05 山东百多安医疗器械股份有限公司 一种能提高软骨修复能力的水凝胶复合支架
CN117339013B (zh) * 2023-12-04 2024-02-13 山东百多安医疗器械股份有限公司 一种能提高软骨修复能力的水凝胶复合支架

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