CN113662678A - 一种用于防止血管移植术后狭窄的保护套管及其制备方法 - Google Patents

一种用于防止血管移植术后狭窄的保护套管及其制备方法 Download PDF

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CN113662678A
CN113662678A CN202110947971.7A CN202110947971A CN113662678A CN 113662678 A CN113662678 A CN 113662678A CN 202110947971 A CN202110947971 A CN 202110947971A CN 113662678 A CN113662678 A CN 113662678A
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敖强
全亮
王洋
王云兵
杨立
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Abstract

本发明公开了一种用于防止血管移植术后狭窄的保护套管及其制备方法，涉及医疗器械技术领域，其技术方案要点是：血管保护套管包括内层和外层，内层与血管接触，由明胶、纤维蛋白胶、壳聚糖及海藻酸等可以快速降解的材料构成，并且含有促进血管内皮细胞生长的药物组分；外层的降解速度慢于内层，可以由聚酯类等材料构成，并且内含抑制平滑肌细胞增殖的药物组分。该保护套管具有双层结构，双层结构且分别负载不同功能药物的血管保护材料，并且该材料的药物有序释放，与吻合部位血管修复时间相匹配。

Description

一种用于防止血管移植术后狭窄的保护套管及其制备方法
技术领域
本发明涉及医疗器械技术领域，更具体地说，它涉及一种用于防止血管移植术后狭窄的保护套管及其制备方法。
背景技术
血管移植术是当血管有缺损不能直接缝合时，常用的血管桥接方法。在修复肢体动脉缺损和冠状动脉旁路手术中的主要方法是自体静脉移植。当移植的静脉血管暴露于具有较高血压的动脉循环中时，机械扩张和湍流剪切应力会使移植的静脉血管壁遭受严重损伤。而这些机械损伤会导致早期形成急性血栓形成、中期出现内膜增生以及随后由多种系统性风险因素导致的血管粥样硬化变性，而这些因素都会导致血管移植的失败。
药物抗血小板、积极的降脂治疗或外科非接触式静脉采集技术在一定程度上可以抑制移植的静脉血管内膜增生减少血栓发生，但仍旧无法长期维持血管的通畅性。在原有的血管移植部位增加外部装置可以减少机械扩张、湍流剪切应力以稳定血流动力学以及抑制内膜增生来提高血管移植术的预后。
现有的血管移植保护装置主要为镍钛合金、钛合金、医用不锈钢以及聚四氟乙烯等不可降解的医用生物材料，但这些永久性的血管保护装置长期留在体内会存在慢性炎症、局部感染、静脉外膜纤维化等潜在的并发症。因此研究一种新的血管保护材料，既能够预防血管移植术后移植部位的血管发生再狭窄和血栓发生，又能防止内膜增生，具有重要的实用价值。
专利文献CN102551930B发明公开了一种冠状动脉旁路移植术桥血管近端吻合口支撑装置及其制备方法，支撑装置的弧形本体由镍钛合金金属丝编织而成，支撑装置边缘的底边和端口用重金属材料制成，支撑边缘和弧形丝材之间通过医用不可吸收缝合线包裹固定。该发明中的装置可以支撑吻合口的血管不出现塌陷或被挤压变形；延缓吻合口闭塞；复查时易于准确快速完成术后冠状动脉造影检查。但该装置结构复杂，制备困难，而且仅仅具有防止移植静脉扩张的作用，不具备药物活性。
专利文献CN204542462U实用新型公开了一种冠状动脉旁路血装保护架。该保护架由多个细丝构成的筒形支架单元组成的筒形套装保护架，筒形支架单元结构为反复的之字形面的筒状，相邻的两个筒形支架单元相互穿绕。该保护架增加了静脉血管承受的压力，可防止血管膨胀以维持血液流速恒定，避免病变产生，提高了移植静脉血管的使用寿命。但无法避免永久性的植入材料引发潜在并发症的风险，而且仅仅具有防止移植静脉扩张的作用，不具备药物活性。
专利文献2CN101612052A提供了一种防止冠状动脉旁路移植术后桥血管再狭窄的自体双层静脉移植系统。自体双层静脉移植系统，包括内层静脉、动脉血管和外支撑静脉，内层静脉是冠状动脉旁路移植术中的移植静脉(桥血管)，外支撑静脉套于内层静脉外，作为内层静脉的外支撑。该移植系统所用材料生物相容性良好无需成本，顺应性和弹性与动脉匹配，能够限制静脉扩张、抑制新生内膜过度增殖，预防再狭窄。但该发明方法需从患者身体中选取更多更粗的静脉血管，会对患者造成更大的伤害，而且不具备药物活性。
发明内容
本发明的目的是提供一种用于防止血管移植术后狭窄的保护套管及其制备方法，该保护套管能够提供一种具有双层结构，且分别负载不同功能药物的血管保护材料，并且该材料的药物释放阶段与吻合部位血管修复阶段相匹配；且该保护材料可以根据实际情况对血管吻合部位进行包覆，提高对血管的保护作用。
本发明的上述技术目的是通过以下技术方案得以实现的：一种用于防止血管移植术后狭窄的保护套管，包括内层和外层，所述内层与血管相接触，其构成材料可快速降解，并且含有促进血管内皮细胞生长的药物组分；所述外层的降解速度慢于内层，并且内含抑制平滑肌细胞增殖的药物组分。
通过采用上述技术方案，通过设置内层和外层可以使得在血管移植术后，保护材料的内层前期发生降解和药物释放，药物分子通过血管吻合处进入血管内部，促进内表皮细胞的增殖，加快内皮化。而后外层材料发生降解释放药物，抑制血管平滑肌的过度增生，防止出现再狭窄。最后，移植的血管与原有血管完成吻合，而保护材料也完全降解。
本发明进一步设置为：所述内层由高降解率生物材料制成，所述高降解率生物材料包括明胶、纤维蛋白胶、壳聚糖或海藻酸，且所述内层含有血管内皮生长因子和/或辛伐他汀。
通过采用上述技术方案，内层可以促进血管内皮细胞生长，促进内皮化。
本发明进一步设置为：所述外层由低降解率生物材料制成，所述低降解率生物材料包括聚酯类材料及天然材料，且所述外层材料含有甲基强的松龙和/或黄芪甲苷。
通过采用上述技术方案，外层能够抑制血管平滑肌增生，防止血管狭窄。
本发明还提供了以下用于防止血管移植术后狭窄的保护套管的制备方法：
(1)将聚酯类材料或天然材料与甲基强的松龙共溶后，采用静电纺丝技术或流延法获得片状的保护套管外层；
(2)制备明胶、纤维蛋白胶、壳聚糖或海藻酸溶液，并与血管内皮生长因子和/或辛伐他汀共混，将共混溶液采用流延法在上述套管外层材料的表面形成凝胶作为血管接触层，即为内层。
综上所述，本发明具有以下有益效果：本发明的保护套管通过设置内层和外层，便于在血管移植术后，保护套管的内层前期发生降解和药物释放，药物分子通过血管吻合出进入血管内部，促进血管内皮细胞生长，加快内皮化；而保护套管的外层材料发生降解较慢，可以缓慢释放药物，抑制血管平滑肌的过度增生，防止血管出现再狭窄；最后，移植的血管与原有血管完成吻合，而保护套管材料也完全降解。
附图说明
图1是本发明实施例中一种用于防止血管移植术后狭窄的保护套管的结构示意图；
图2是本发明实施例中一种用于防止血管移植术后狭窄的保护套管在血管移植手术过程中的使用方式的示意图；
图3是本发明实施例中一种用于防止血管移植术后狭窄的保护套管保护材料的图像((A)和(B)是护套的轴向和径向照片；(C)和(D)是PLCL保护套管的SEM图像；(E)和(F)是PLCL/甲基强的松龙保护材料的SEM图像；(G)、(H)是PLCL/辛伐他汀保护材料的SEM图像；
图4是本发明实施例中一种用于防止血管移植术后狭窄的保护套管PLCL/甲基强的松龙和甲基强的松龙的1HNMR图谱；
图5是本发明实施例中一种用于防止血管移植术后狭窄的保护套管PLCL/辛伐他汀和辛伐他汀的1HNMR图谱。
图中：1、内层；2、外层。
具体实施方式
以下结合附图1-5对本发明作进一步详细说明。
实施例1：一种用于防止血管移植术后狭窄的保护套管，如图1、图2所示，包括内层和外层，内层1与血管相接触，其构成材料可快速降解，并且含有促进血管内皮细胞生长的药物组分；外层2的降解速度慢于内层，并且内含抑制平滑肌增生的药物组分。
在本实施例中，血管移植术后，保护套管的内层前期发生降解和药物释放，药物分子通过血管吻合处进入血管内部，促进血管内皮细胞生长，加快内皮化。而后外层材料发生降解释放药物，抑制血管平滑肌的过度增生，防止血管出现再狭窄。最后，移植的血管与原有血管完成吻合，而保护套管材料也完全降解。
内层1由高降解率生物材料制成，高降解率生物材料包括明胶、纤维蛋白胶、壳聚糖或海藻酸等，且内层1含有血管内皮生长因子和/或辛伐他汀。
在本实施例中，内层可以促进血管内皮细胞生长，促进内皮化。
外层2由低降解率生物材料制成，低降解率生物材料包括聚酯类材料及天然材料等，且外层2材料含有甲基强的松龙和/或黄芪甲苷。
在本实施例中，外层能够抑制血管内层平滑肌的过度增生，防止血管狭窄。
在本发明的上述实施例中，该保护套管的内层前期发生降解和药物释放，药物分子通过血管吻合出进入血管内部，促进血管内皮细胞生长，加快内皮化。而后外层材料发生降解释放药物，抑制血管内层平滑肌的过度增生，防止血管狭窄。最后，移植的血管与原有血管完成吻合，而保护套管材料也完全降解。
实施例2：一种用于防止血管移植术后狭窄的保护套管的制备方法，具体包括以下制备步骤：
(1)将聚L-丙交酯-己内酯或聚乳酸与甲基强的松龙共溶于三氟乙醇中，采用静电纺丝技术获得片状的保护套管外层；
(2)将壳聚糖溶于稀盐酸溶液中和滴加辛伐他汀溶液，将壳聚糖/辛伐他汀溶液用流延法在保护材料外层的表面形成凝胶作为内层。
实施例3：一种用于防止血管移植术后狭窄的保护套管的制备方法，具体包括以下制备步骤：
(1)将甲基强的松龙和聚L-丙交酯-己内酯共溶于三氟乙醇中，用静电纺丝技术获得片状的保护套管外层；
(2)将冻干人纤维蛋白原溶解液注入冻干人纤维蛋白原瓶内，获得冻干人纤维蛋白原溶液；将冻干人凝血酶溶解液，注入冻干人凝血酶瓶内，获得冻干人凝血酶溶液；
(3)冻干人纤维蛋白原溶液和冻干人凝血酶溶液通过Y型转换器喷涂到血管吻合口上，形成纤维蛋白胶，即内层；
(4)保护材料外层部分覆盖在内层上，实现对血管移植吻合口的保护作用。
实施例4：一种用于防止血管移植术后狭窄的保护套管的制备方法，具体包括以下制备步骤：
(1)将10％(w/w)PLCL溶解于5mL三氟乙醇中；
(2)将静电纺丝电压、工作温度和湿度分别设置为15kV、22±3℃和20-30％，注射器喷嘴和收集器之间的距离为15cm，其中收集器是外径为3mm的金属圆筒，同心注射器喷嘴，针头直径为0.51mm，流速为0.6ml/h，复合护套的纺丝时间设定为200min，最终获得PLCL保护套管。
实施例5：一种用于防止血管移植术后狭窄的保护套管的制备方法，具体包括以下制备步骤：
(1)将30mg甲基强的松龙或30mg辛伐他汀与10％(w/w)PLCL共溶于5ml三氟乙醇中；
(2)将静电纺丝电压、工作温度和湿度分别设置为15kV、22±3℃和20-30％，注射器喷嘴和收集器之间的距离为15cm，其中收集器是外径为3mm的金属圆筒，同心注射器喷嘴，针头直径为0.51mm，流速为0.6ml/h，复合护套的纺丝时间设定为200min，最终获得PLCL保护套管。
通过本发明的上述实施例2-实施例5，便于制备得本发明实施例1中的用于防止血管移植术后狭窄的保护套管。
本具体实施例仅仅是对本发明的解释，其并不是对本发明的限制，本领域技术人员在阅读完本说明书后可以根据需要对本实施例做出没有创造性贡献的修改，但只要在本发明的权利要求范围内都受到专利法的保护。

Claims (4)

1.一种用于防止血管移植术后狭窄的保护套管，包括内层(1)和外层(2)，其特征是：所述内层(1)与血管相接触，其构成材料可快速降解，并且含有促进血管内皮细胞生长的药物组分；所述外层(2)的降解速度慢于内层(1)，并且内含抑制平滑肌细胞增殖的药物组分。
2.根据权利要求1所述的一种用于防止血管移植术后狭窄的保护套管，其特征是：所述内层(1)由高降解率生物材料制成，所述高降解率生物材料包括明胶、纤维蛋白胶、壳聚糖或海藻酸，且所述内层(1)含有血管内皮生长因子和/或辛伐他汀。
3.根据权利要求1所述的一种用于防止血管移植术后狭窄的保护套管，其特征是：所述外层(2)由低降解率生物材料制成，所述低降解率生物材料包括聚酯类材料及天然材料，且所述外层(2)材料含有甲基强的松龙和/或黄芪甲苷。
4.根据权利要求1-3任意一项所述的一种用于防止血管移植术后狭窄的保护套管的制备方法，步骤如下：
(1)将聚酯类材料或天然材料与甲基强的松龙共溶后，采用静电纺丝技术或流延法获得片状的保护套管外层；
(2)制备明胶、纤维蛋白胶、壳聚糖或海藻酸溶液，并与血管内皮生长因子和/或辛伐他汀共混，将共混溶液采用流延法在上述套管外层材料的表面形成凝胶作为血管接触层，即为内层。
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CN101612052A (zh) * 2009-05-21 2009-12-30 同济大学 防止冠状动脉旁路移植术后桥血管再狭窄的自体双层静脉移植系统
US20140249618A1 (en) * 2013-02-18 2014-09-04 Elutin, Inc. Site specific drug delivery wraps, systems and methods of use thereof
CN107213512A (zh) * 2017-06-16 2017-09-29 南京医科大学第附属医院 一种错时释放双缓释涂层多功能小口径人工血管及其制备方法

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101612052A (zh) * 2009-05-21 2009-12-30 同济大学 防止冠状动脉旁路移植术后桥血管再狭窄的自体双层静脉移植系统
US20140249618A1 (en) * 2013-02-18 2014-09-04 Elutin, Inc. Site specific drug delivery wraps, systems and methods of use thereof
CN107213512A (zh) * 2017-06-16 2017-09-29 南京医科大学第附属医院 一种错时释放双缓释涂层多功能小口径人工血管及其制备方法

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