CN1605366A - 一种开有非穿透性槽或盲孔的血管支架及其制作方法 - Google Patents
一种开有非穿透性槽或盲孔的血管支架及其制作方法 Download PDFInfo
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Abstract
本发明提出了一种开有非穿透性槽或盲孔的血管支架，属于医疗器械技术领域。本支架由直形主支撑条和连接主支撑条的连接条构成，所述主支撑条中部的外表面开有非穿透性的槽或打有多个盲孔，在该槽或孔中嵌有药物涂层。本发明支架的槽或孔开在主支撑条上，其深度不影响条的支撑力。槽可以是直线型的，也可以是折线或曲线型，孔的分布可以是规则的，也可以是不规则的。本发明采用激光加工、电子束加工或化学刻蚀方式在所述主支撑条上开非穿透性的槽或打盲孔。本发明的这种支架改善了药物涂层在支架上的附着能力，延长了药物的释放时间，降低了支架植入后的再狭窄率。
Description
技术领域
本发明属于医疗器械技术领域，特别涉及在治疗心血管疾病的手术中，植入冠状动脉血管的支架设计。
背景技术
在治疗心血管疾病的各种手术中，经皮球囊腔内冠状动脉成形术(PTCA)是近年来迅速发展起来的一项新的治疗手段，它通过从股动脉切入的支架/球囊导管输送系统，本申请人提出一种由直形主支撑条和连接主支撑条的马蹄形连接条构成的支架，该支架在医学影像设备的引导下，与球囊导管一切被送达冠状动脉的病变狭窄处，通过球囊的充气扩张，使支架撑开狭窄的血管，从而达到治疗的目的。
通常的金属支架在植入人体之后，由于金属表面直接与血管壁及血液接触，刺激了人体对异物的排异功能，金属表面很快被一层粘膜包覆，粘膜的生长有可能减小甚至阻塞撑开的支架所形成的血流通道，造成再狭窄，研究表明，支架植入患者的再狭窄率约30％。
为了防止再狭窄的发生，一些能阻止粘膜生长的药物被涂覆在支架的表面。由于支架在送达血管狭窄处之后被球囊撑开，形状有很大的改变，特别是一些曲率较大的连接条的弯曲处，形状的改变也很大，很容易使涂覆在此处的药物涂层发生脱落。脱落的药物块随血流运动，很可能形成血栓，造成新的危害。
发明内容
本发明的目的是为克服已有技术的不足之处，提出一种开有非穿透性槽或盲孔的血管支架，可改善药物涂层在支架上的附着能力，延长药物的释放时间。
本发明的另一目的是提出上述具有非穿透性槽或盲孔支架的加工方法，具有操作简单易行的特点。
本发明提出的开有非穿透性槽或盲孔的血管支架，由直形主支撑条和连接主支撑条的马蹄形连接条构成，其特征在于，所述主支撑条的外表面开有非穿透性的槽或打有多个盲孔，在该槽或孔中嵌入药物涂层。
本发明提出制备上述血管支架的一种方法，包括以下步骤：
1)制备(可采用已知方法)或直接选用带有主支撑条及连接条的成型支架；
2)采用激光加工、电子束加工或化学刻蚀方法，在该成型支架的主支撑条上开非穿透性的槽或打盲孔；
3)在所述槽或盲孔中涂覆药物涂层(具体可采用已知方法制备)。
本发明的特点是使药物涂层可嵌入到槽或孔中。槽或孔位于支撑条的中部，其深度不应影响条的支撑力。由于处在主支撑条上而不是连接条上，这些槽或孔在支架被压缩或撑开时基本上不发生变形，或者变形极小，避免了涂层与支架金属表面之间的相对移动，从根本上解决了涂层脱落的问题，改善了药物在支架上的附着能力。又由于药物被镶嵌在槽或孔中，其被血液冲蚀或被血管壁磨蚀的几率也很小，而涂覆的药量则可适当增加，从而延长了药物的释放时间。
本发明的有益效果是：改善药物涂层在支架上的附着能力，延长药物的释放时间，降低了支架植入后的再狭窄率。
附图说明
图1是本发明的支架的平面展开图。
图2是本发明的支架的实施例1局部结构示意图。
图3是本发明的支架的实施例2局部结构示意图。
图4是本发明的支架的实施例3局部结构示意图。
图5是本发明的支架的实施例4局部结构示意图。
具体实施方式
下面结合附图和实施例对本发明作进一步说明。
本发明的支架结构如图1所示，由直形主支撑条2和连接主支撑条的马蹄形连接条3构成，主支撑条2中部的外表面开有非穿透性的槽1(或打有多个盲孔)，在该槽或孔中可嵌有药物涂层(图中未示出)。
本发明的支架的制备方法，包括以下步骤：
1)制备(可采用已知方法)或直接选用带有主支撑条及连接条的成型支架；
2)采用激光加工、电子束加工或化学刻蚀方法，在该成型支架的主支撑条上开非穿透性的槽或打盲孔；
3)在所述槽或盲孔中涂覆药物涂层(具体采用已知方法制备)。
本发明的实施例1的结构如图2所示，图2是支架的局部示意图，在本实施例中，主支撑条2宽度为0.09mm，厚度为0.09mm。利用化学刻蚀技术制作出宽度为0.03mm，长度为0.40～1.90mm(根据不同的主支撑条的长度而定)，深度为0.02mm的非穿透性直槽1。
本实施例中采用化学刻蚀具体方法为：首先在支架表面涂一层耐蚀涂料(本实施例采用丁基橡胶)，用激光束(本实施例采用的激光功率密度为103～104W/cm2)烧蚀掉支架主支撑条上将要刻槽或打孔处的耐蚀涂料，然后将支架置于腐蚀液中进行刻蚀。
本发明的实施例2的结构如图3所示，图3是支架的局部示意图，在本实施例中，主支撑条2宽度为0.10mm，厚度为0.10mm。利用激光技术制作出直径为0.03mm，深度为0.02mm的呈直线排列的盲孔4。
本实施例采用激光加工的具体方法为：采用波长为1.06μm、光斑直径为30～40μm、激光功率密度为107～108W/cm2的脉冲激光束，在所述主支撑条上开非穿透性的槽或打盲孔；
本发明的实施例3的结构如图4所示，图4是支架的局部示意图，在本实施例中，主支撑条2宽度为0.11mm，厚度为0.10mm。利用高能电子束制作出宽度为0.04mm，端点直线距离为0.40～1.90mm(根据不同的主支撑条的长度而定)，深度为0.018mm的折线(或曲线)型非穿透性槽5。
本实施例采用电子束加工具体方法为：将所述支架放在真空室中，抽真空至10-3～10-4Pa，电流5～8mA，通过磁聚集系统将电子束汇聚成直径30～40μm的斑，使功率密度达到107W/cm2后，在该支架的支撑条上开非穿透性的槽或打盲孔。
本发明的实施例4的结构如图5所示，图5是支架的局部示意图，在本实施例中，主支撑条2宽度为0.12mm，厚度为0.12mm。利用激光技术制作(具体方法同实施例2)出直径为0.04mm，深度为0.02mm的呈不规则分布的盲孔6。
Claims (9)
1.一种开有非穿透性槽或盲孔的血管支架，由直形主支撑条和连接主支撑条的连接条构成，其特征在于，所述主支撑条的外表面开有非穿透性的槽或打有多个盲孔，在该槽或孔中嵌有药物涂层。
2.如权利要求1所述的血管支架，其特征在于，所述槽是直线型、折线型或曲线型。
3.如权利要求1所述的血管支架，其特征在于，所述盲孔的排列呈直线式，呈曲折式，或其他不规则的分布形式。
4.如权利要求1或2所述的血管支架，其特征在于，所述槽的深度为0.018～0.02mm，槽的宽度为0.03～0.04mm。
5.如权利要求1或3所述的血管支架，其特征在于，所述盲孔的深度为0.018～0.02mm，盲孔的直径为0.03～0.04mm。
6.一种开有非穿透性槽或盲孔的血管支架的制备方法，包括以下步骤：
1)制备或直接选用带有主支撑条及连接条的成型支架；
2)采用激光加工、电子束加工或化学刻蚀方法，在该成型支架的主支撑条上开非穿透性的槽或打盲孔；
3)在所述槽或盲孔中涂覆药物涂层。
7.如权利要求6所述的方法，其特征在于，所述步骤2)中采用激光加工方法为：采用波长为1.06μm、光斑直径为30～40μm、激光功率密度为107～108W/cm2的脉冲激光束，在所述主支撑条上开非穿透性的槽或打盲孔；
8.如权利要求6所述的方法，其特征在于，所述步骤2)采用电子束加工方法为：将所述支架放在真空室中，抽真空至10-3～10-4Pa，电流5～8mA，通过磁聚集系统将电子束汇聚成直径30～40μm的斑，使功率密度达到107W/cm2，在该支架的支撑条上开非穿透性的槽或打盲孔。
9.如权利要求6所述的方法，其特征在于，所述步骤2)中采用化学刻蚀方法为：首先在支架表面涂一层耐蚀涂料，用激光束烧蚀掉支架主支撑条上将要刻槽或打孔处的耐蚀涂料，然后将支架置于腐蚀液中进行刻蚀。
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| PCT/CN2005/001773 WO2006058479A1 (fr) | 2004-12-03 | 2005-10-27 | Endoprothese a rainures impenetrables ou trous borgnes et son procede de fabrication |
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| WO2009052703A1 (en) * | 2007-10-17 | 2009-04-30 | Microport Medical (Shanghai) Co., Ltd. | Nested stent in body lumen |
| WO2010048757A1 (zh) * | 2008-10-31 | 2010-05-06 | Dong Heyan | 微盲孔支架承载基因物质的制备方法 |
| WO2010051740A1 (zh) * | 2008-11-04 | 2010-05-14 | 微创医疗器械(上海)有限公司 | 开有载药槽的冠状动脉血管支架 |
| WO2010127584A1 (zh) * | 2009-05-07 | 2010-11-11 | 微创医疗器械(上海)有限公司 | 一种凹槽携载式涂层可降解型药物洗脱支架 |
| CN101327343B (zh) * | 2007-06-20 | 2012-05-23 | 乐普（北京）医疗器械股份有限公司 | 一种复合药物血管支架及其制备方法 |
| TWI407942B (zh) * | 2010-02-09 | 2013-09-11 | Univ Nat Taiwan | 具預防血管狹窄之心血管支架 |
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- 2004-12-03 CN CN200410096617.4A patent/CN1605366A/zh active Pending
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