CN107951595A - 一种带有可吸收覆膜的血管支架 - Google Patents
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Abstract
本发明公开了一种带有可吸收覆膜的血管支架,包括管状支架和覆膜单元;管状支架为柔性管状结构,包括依次排布的近端、中间部分和远端;覆膜单元包覆在管状支架上;覆膜单元由可降解高分子材料构成。本发明中的覆膜单元可以被生物组织吸收,减少内膜增生和再狭窄风险,保持正常血流通道,能更加有效地治疗血管狭窄。
Description
技术领域
本发明涉及一种血管支架,具体涉及一种带有可吸收覆膜的血管支架。
背景技术
为避免外科手术高风险,血管内介入治疗逐渐成为治疗动脉瘤的主要方法,血管内介入治疗具有创伤小、并发症少、安全性高、患者痛苦少以及年高病情重也能耐受的优势。覆膜支架,又称为带膜支架,由支架与薄层的膜共同组成,指裸管状支架内面或外面部分或完全覆盖膜性材料的人工体内移植物;利用支架的支撑功能与膜的覆盖功能,起到封闭破裂或穿孔的血管作用,还可用于封堵动脉瘤或动脉瘘。覆膜支架既保留了普通支架的支撑功能,又具有膜性材料的特性,能有效改善病变血管的异常血流动力学。除了动脉瘤相关的介入治疗,在急慢性血管损伤和外周血管病变的治疗中,覆膜支架得到了广泛的应用。比如治疗血管狭窄。然而在手术过程中血管可能被导丝、导管等器械损伤造成穿孔。
早期的覆膜材料主要是聚乙烯、尼龙、涤纶、聚氨酯和ePTFE(多孔聚四氟乙烯)等,由于无法降解,不利于细胞黏附,容易引起内膜增生、管腔狭窄以及异物所引起的不良反应,因而已逐渐被淘汰。
目前,用于临床的冠状动脉覆膜支架有雅培血管仪器公司(Abbott VascularInstruments Deutschland GmbH)生产的JOSTENT GraftMaster预装带膜支架系统。该系统仍存在诸多缺点:①由于采用双层管状支架与ePTFE的夹心设计,总厚度高达0.3mm,其柔顺性与通过性均较差,一般不适用于处理远段血管穿孔或直径<2.75mm的穿孔;当穿孔的近段存在严重钙化、严重扭曲或已置入支架时,往往很难将带膜支架送至穿孔部位。②由于覆膜材料ePTFE无法有效降解,很难完全内皮化,有可能增加迟发血栓风险。③置入覆膜支架后的再狭窄率高出31.6%,且多位于支架边缘,如支架边缘和中央的发生率分别为29.8%和8.8%。
因此,为避免血管狭窄手术过程中血管易被导丝、导管等器械损伤造成穿孔的问题,更好的保障手术安全,本发明采用生物可降解材料制成的可吸收覆膜,临时封堵穿孔,长时间后被人体降解不至于发生血管再狭窄,减少血管内膜增生风险。
发明内容
有鉴于现有技术的上述缺陷,本发明所要解决的技术问题是如何减少血管内膜增生和再狭窄风险。
针对治疗血管狭窄手术过程中血管易被导丝、导管等器械损伤造成穿孔的问题,本发明提供了一种带有可吸收覆膜的血管支架,为覆膜支架中的一种。该带有可吸收覆膜的血管支架包括管状支架和覆膜单元;管状支架为柔性管状结构,包括依次排布的近端、中间部分和远端;覆膜单元包覆在管状支架上;覆膜单元由可降解高分子材料构成。其覆膜单元临时封堵穿孔,长时间后被人体降解不至于发生血管再狭窄。
进一步地,管状支架具有第一状态和第二状态;在输送时,管状支架处于第一状态;当到达患病部位时,管状支架转变为第二状态;第二状态为可扩展的热定形结构,其直径大于第一状态下管状支架的直径。
进一步地,第一状态下管状支架的直径在8mm以下,以便通过血管输送到患病部位。
进一步地,中间部分被设置为通过响应轴向压力而扩展成直径大于近端和远端的直径。
进一步地,中间部分被设置为通过响应轴向压力而扩展成直径小于或等于血管畸形的直径。
进一步地,管状支架由弹性金属材料构成。
进一步地,弹性金属材料包括不锈钢和/或镍钛合金。
进一步地,管状支架为单层结构。
进一步地,可降解高分子材料包括聚乳酸、聚羟基乙酸和聚己内酯中的一种或者多种。覆膜单元为单层膜。
在一个具体实施方式中,采用热熔工艺将覆膜单元固定包覆在管状支架的外表面。
在另一个具体实施方式中,覆膜单元为编织结构;覆膜单元为通过缝线缝合固定在管状支架的外表面;缝线采用可吸收材料制成。
本发明的有益效果为:
较之于现有技术,支架的整体厚度更薄,更容易通过血管的狭窄部位;采用可降解吸收覆膜,减少内膜增生和再狭窄风险。
以下将结合附图对本发明的构思、具体结构及产生的技术效果作进一步说明,以充分地了解本发明的目的、特征和效果。
附图说明
图1是本发明的一个较佳实施例的一种带有可吸收覆膜的血管支架的结构示意图。
具体实施方式
以下参考附图来详细描述本发明的优选实施例。
如图1所示,本发明提供了一种带有可吸收覆膜的血管支架,用于治疗管腔内血管畸形。该带有可吸收覆膜的血管支架包括:管状支架1和覆膜单元2,管状支架1为柔性管状结构,包括依次排列的近端、中间部分和远端;覆膜单元2包覆在管状支架1上。其中,覆膜单元2为编织结构,覆膜单元2通过可吸收缝线缝合固定在管状支架1的外表面,缝线采用可吸收材料制成。或者采用热熔工艺将覆膜单元2固定包覆在管状支架1的外表面。优选地,管状支架1为单层结构;覆膜单元2为单层膜。
管状支架1具有第一状态和第二状态;在输送时,管状支架1处于第一状态;当到达患病部位时,管状支架1转变为第二状态;第二状态为可扩展的热定形结构,其直径大于第一状态下管状支架1的直径。第一状态下管状支架1的直径在8mm以下,以便顺利通过血管输送到患病部位。
管状支架1的中间部分被设置为通过响应轴向压力而扩展成直径大于近端和远端的直径。进一步地,管状支架1的中间部分被设置为通过响应轴向压力而扩展成直径小于或等于血管畸形的直径。管状支架1由弹性金属材料构成,弹性金属材料包括不锈钢和/或镍钛合金。
覆膜单元2由可降解高分子材料构成。以可降解的成膜材料(即可降解高分子材料)作为覆膜单元2,在生物体内可控分解并参与人体的新陈代谢,并最终排出体外。生物可控降解材料的优点在于,在置入带有可吸收覆膜的血管支架数月、血管损伤修复后,覆膜单元2能完全降解,降低了支架血栓和再狭窄发生率。
可降解的成膜材料包括聚乳酸(PLA)、聚羟基乙酸或聚己内酯(PCL)等可降解高分子材料。PCL为半结晶性高分子,极易与其他高分子共混;同时,PCL作为脂肪族聚酯类高分子,生物相容性良好,可降解及速率可控,有一定的孔隙及机械强度,具有较高韧性。本实施例利用PCL制备覆膜单元2,使得单层带有可吸收覆膜的血管支架具有可控降解特性、柔韧性和良好拉伸性,既能有效封堵动脉破口,又能在血管破口完全修复后实现覆膜完全降解,从而有效降低支架血栓和再狭窄的发生率。
以上详细描述了本发明的较佳具体实施例。应当理解,本领域的普通技术人员无需创造性劳动就可以根据本发明的构思作出诸多修改和变化。因此,凡本技术领域中技术人员依本发明的构思在现有技术的基础上通过逻辑分析、推理或者有限的实验可以得到的技术方案,皆应在由权利要求书所确定的保护范围内。
Claims (10)
1.一种带有可吸收覆膜的血管支架,其特征在于,包括管状支架和覆膜单元;所述管状支架为柔性管状结构,包括依次排布的近端、中间部分和远端;所述覆膜单元包覆在所述管状支架上;所述覆膜单元由可降解高分子材料构成。
2.根据权利要求1所述的带可吸收覆膜的血管支架,其特征在于,所述管状支架具有第一状态和第二状态;在输送时,所述管状支架处于所述第一状态;当到达患病部位时,所述管状支架转变为所述第二状态;所述第二状态为可扩展的热定形结构,其直径大于所述第一状态下所述管状支架的直径。
3.根据权利要求2所述的带可吸收覆膜的血管支架,其特征在于,所述第一状态下所述管状支架的直径在8mm以下,以便通过血管输送到患病部位。
4.根据权利要求2所述的带可吸收覆膜的血管支架,其特征在于,所述中间部分被设置为通过响应轴向压力而扩展成直径大于所述近端和远端的直径。
5.根据权利要求2所述的带可吸收覆膜的血管支架,其特征在于,所述中间部分被设置为通过响应轴向压力而扩展成直径小于或等于血管畸形的直径。
6.根据权利要求1所述的带可吸收覆膜的血管支架,其特征在于,所述管状支架由弹性金属材料构成。
7.根据权利要求6所述的带可吸收覆膜的血管支架,其特征在于,所述弹性金属材料包括不锈钢和/或镍钛合金;所述管状支架为单层结构。
8.根据权利要求1所述的带可吸收覆膜的血管支架,其特征在于,所述可降解高分子材料包括聚乳酸、聚羟基乙酸和聚己内酯中的一种或者多种;所述覆膜单元为单层膜。
9.根据权利要求1-8任一项所述的带可吸收覆膜的血管支架,其特征在于,采用热熔工艺将所述覆膜单元固定包覆在所述管状支架的外表面。
10.根据权利要求1-8任一项所述的带可吸收覆膜的血管支架,其特征在于,所述覆膜单元为编织结构;所述覆膜单元为通过缝线缝合固定在所述管状支架的外表面;所述缝线采用可吸收材料制成。
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CN101951856A (zh) * | 2008-02-18 | 2011-01-19 | Aga医药有限公司 | 用于修补血管畸形的支架/覆膜支架及相关方法 |
EP2596754A1 (en) * | 2011-11-23 | 2013-05-29 | Occlutech Holding AG | Medical implant and manufacturing method thereof |
CN106175980A (zh) * | 2015-05-04 | 2016-12-07 | 聂绍平 | 生物可降解高分子膜单层金属覆膜支架 |
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CN101951856A (zh) * | 2008-02-18 | 2011-01-19 | Aga医药有限公司 | 用于修补血管畸形的支架/覆膜支架及相关方法 |
EP2596754A1 (en) * | 2011-11-23 | 2013-05-29 | Occlutech Holding AG | Medical implant and manufacturing method thereof |
CN106175980A (zh) * | 2015-05-04 | 2016-12-07 | 聂绍平 | 生物可降解高分子膜单层金属覆膜支架 |
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CN113017914A (zh) * | 2021-03-17 | 2021-06-25 | 复旦大学附属中山医院 | 一种防止覆膜支架出入口内膜增生的外周血管复合支架 |
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