CN108434580B - 一种头端设双涂层的可解脱微导管 - Google Patents
一种头端设双涂层的可解脱微导管 Download PDFInfo
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Abstract
本发明涉及一种头端设双涂层的可解脱微导管，包括微导管主体，所述微导管主体的一端连通的导管座，所述微导管主体的另一端还连接有可解脱的微导管头端，所述微导管头端外表面涂覆有可膨胀的内层涂层，所述内层涂层上还密封压紧包覆有可变松散的外层涂层。本发明的有益效果是能提高微创介入治疗脑血管畸形的治愈性栓塞率，降低因液体栓塞剂返流导致的并发症及栓塞不全相关的出血，简化治疗过程，减少经济负担。
Description
技术领域
本发明涉及医用微导管设计，具体是一种头端设双涂层的可解脱微导管。
背景技术
脑动静脉畸形(arterioovenous malformation，AVM)是颅内常见的先天性血管疾病，治疗方法主要包括手术切除、血管内栓塞以及立体定向放射治疗。近年来，随着栓塞材料和技术的进步，应用新型液体栓塞剂(Onyx、Phil等，下称“胶”)经血管内栓塞治疗已成为治疗脑AVM的一种重要方法。栓塞过程中通常需要少量栓塞剂的返流，以阻断近端供血动脉，以保证后续的注胶更好的向目标位置弥散。但是返流的胶可能造成多种风险，一是返流进入正常脑组织的供血动脉导致脑梗，另一方面会粘滞导管，使其无法拔除，或在拔管中导致血管破裂出血风险。而由于担心这两种风险的发生又会导致返流不足，无法使胶充分向病灶内弥散，从而无法达到预期的目标。头端可解脱设计的微导管(detachable tipmicrocatheter,DTM)近年已被应用于临床，并显著降低了拔管困难及相关的并发症。但是返流导致正常动脉闭塞仍是重要的潜在风险。目前可以通过配合另一根微导管向栓塞微导管近端填塞弹簧圈或注射医用胶帮助阻断近端血流，这种技术被称为“压力锅技术”。在临床实践中已经证实这种技术的有效性，但是在操作上由于双导管的操作增加了手术的复杂程度，手术并发症率以及手术费用。而供血动脉的直径也会限制这种技术的应用，当供血动脉直径过细时，无法使两根导管同时到位进行上述操作。
发明内容
本发明的目的在于克服现有技术的不足，解决单微导管实现“压力锅技术”操作复杂的难题。
为达到上述发明目的，提供一种头端设双涂层的可解脱微导管，包括微导管主体，所述微导管主体的一端连通的导管座，所述微导管主体的另一端还连接有可解脱的微导管头端，所述微导管头端外表面涂覆有可膨胀的内层涂层，所述内层涂层上还密封压紧包覆有可变松散的外层涂层。
导管座用于转接；微导管主体是用于进入患者大血管的一段，一般设置为管状；微导管头端用于超选远端血管部分，一般设置为管状或杆状。使用时，导丝或注射液体通过导管座进入微导管。
微导管头端的连接部位设扩径管，其相较微导管头端的远端管径增大，微导管主体插入扩径管的远端，可以通过在体外牵拉微导管使微导管主体从扩径管断开。
密封压紧是指把所述内层涂层完全包裹住，使之不与外界环境接触，同时维持内层涂层在输送至目标血管之前处于压缩状态。
可变松散是指外层涂层在经过特定的物理或化学反应后，本密封压紧的形态变得疏松/融化/溶解/降解等情况，让得原先封闭于其内部的内层涂层材料接触到外界。
优选的，所述内层涂层为套于微导管头端外周面的环形结构，所述环形结构设置于微导管头端上靠近所述微导管主体一端的位置。
套于微导管头端外周面的环形结构是指在微导管头端的周向上连续涂覆。
优选的，所述内层涂层为套于微导管头端外周面的环形结构，且多个环形结构之间分隔布置。
分隔布置亦可被描述为，在长度方向上呈节段性环形固定在微导管头端管外。环形结构之间的间隙可以直接裸露微导管头端管，也可以用外层涂层填充。
优选的，所述内层涂层为水凝胶泡沫材料。
水凝胶泡沫材料的特性为亲水、大孔、聚合，一般可采用含有泡沫稳定剂和可自由基聚合的亲水烯烃单体与多烯官能团的交联剂交联的聚合物或共聚物。
优选的，所述水凝胶泡沫材料中添加显影剂。
显影剂一般可采用钽粉。
优选的，所述内层涂层成分主要为均质铺设固定在微导管头端外周面上的颗粒，所述外层涂层包裹于颗粒外表面。
所述颗粒通过粘结剂或物理镶嵌等方式，以不可释放的形态连接在微导管头端外表面。
优选的，所述外层涂层成分为一种与二甲基亚砜接触发生降解且难溶于水的材料。
与二甲基亚砜(DMSO)接触发生降解且难溶于水的材料一般可选用3,3’,4,4’-二苯砜四羧酸二酐(DSDA)作为外层涂层的主要成分。
优选的，所述外层涂层为临界点稍高于人体的温度敏感涂料。
本处所指的温度敏感涂料在稍高于人类体温下崩解。应用时，使用加热的微导丝或注射热盐溶液短暂进入，外层涂层即会融化降解。
优选的，所述外层涂层为水溶性可降解材料。
水溶性可降解材料可选用淀粉、壳聚糖等。
优选的，所述微导管头端的靠近末端位置和微导管主体的靠近另一端位置各有一个显影标记。
微导管头端的末端是指微导管头端上远离微导管主体的端部，即其自由端。微导管主体的另一端即是指微导管主体连接微导管头端一侧的端部。显影标记皆设置于靠近末端位置。
显影标记可设置为套于微导管头端、微导管主体外表面的环状，从而提升其在血管内的可识别角度。
内层涂层外有外层涂层保护，一方面提高导管的通过性，另一方面避免内层涂层提前膨胀；在微导管到位后，内层涂层遇血液后缓慢膨胀，可完全阻断该血管血流，有效防止在注射栓塞过程中发生栓塞剂返流；由于内层涂层膨胀后充分固定微导管头端，完成注胶后，在解脱位置离断微导管本体将更加容易，减少拔管相关并发症。
内层涂层的环形结构构造，将微导管头端的外周面无间隙地包裹，从而避免膨胀后微导管头端本身与血管壁接触，降低相关并发症的发生；而环形结构设置于微导管头端上靠近所述微导管主体一端的位置，降低了胶的无效使用量。
多个环形结构之间分隔布置，可避免使微导管头端顺应性变差，增加其在迂曲血管中的通过能力，同时增加了内层涂层整体与血管的摩擦力。
内层涂层采用水凝胶泡沫材料，遇血液后有自我扩张能力，使用含有泡沫稳定剂和可自由基聚合的亲水烯烃单体与多烯官能团的交联剂交联的聚合物或共聚物后，其直径可增加25倍以上，水凝胶对血管壁也不易产生刺激；另一方面，如需加速膨胀，也可通过经由微导管本体注射盐溶液增强和促进膨胀，在微导管本体出口与涂层接近的情况下，能实现膨胀的快速响应。
水凝胶泡沫材料中添加显影剂，如钽粉，使植入物能够通过常规的影像技术可见。
均质铺设固定的颗粒，避免了水凝胶在膨胀时可能发生的表层破裂，降低因此产生预测外缝隙的可能性，使得封堵效率的可控性提升。
外层涂层采用与二甲基亚砜接触发生降解且难溶于水的材料(如DSD A)时，在导管到位后可向血管内注射二甲基亚砜(DMSO)促进涂层降解，内层水凝胶暴露于血液发生膨胀。
外层涂层采用临界点稍高于人体的温度敏感涂料时，可让其在稍高于人类体温下实现崩解；必要时，也可使用加热的微导丝或注射热盐溶液短暂进入使得外层融化，在微导管本体出口与涂层接近的情况下，能实现膨胀的快速响应。
外层涂层采用水溶性可降解材料，如淀粉、壳聚糖等，使得内层涂层得以延迟膨胀。
两个显影标记的设置，使得在透视下明确微导管的远端在血管内的定位、与栓塞剂的相对位置以及与是否最终成功解脱。
使用时，外层涂层维持内层涂层在输送至目标血管之前处于压缩状态，微导管到达目标位置后外层涂层缓慢变得松散暴露出内层涂层吸水膨胀，闭塞血管阻断血流。
本发明的有益效果是能提高微创介入治疗脑血管畸形的治愈性栓塞率，降低因液体栓塞剂返流导致的并发症及栓塞不全相关的出血，简化治疗过程，减少经济负担。
附图说明
图1为本发明的整体示意图。
其中：
1-微导管主体 2-导管座 3-微导管头端
4-内层涂层 5-外层涂层 6-显影标记
具体实施方式
以下结合附图和具体实施例，对本发明做进一步说明。
根据图1所示的一种头端设双涂层的可解脱微导管，包括微导管主体1，所述微导管主体1的一端连通的导管座2，导管座2采用鲁尔接头，该鲁尔接头用于连接其他医疗设备如注射器，或用于插入导丝的导管或注射液体进入微导管主体1；微导管头端3的连接部位设扩径管，其相较微导管头端3的远端管径增大，微导管主体1插入扩径管的远端，使其可以通过在体外牵拉微导管使微导管主体1从扩径管断开；所述微导管主体1的另一端还连接有可解脱的微导管头端3，所述微导管头端3外表面涂覆有可膨胀的内层涂层4，所述内层涂层4上还密封压紧包覆有可变松散的外层涂层5。
所述内层涂层4为套于微导管头端3外周面的环形结构，所述环形结构设置于微导管头端3上靠近所述微导管主体1一端的位置，且多个环形结构之间分隔布置。所述内层涂层4为水凝胶泡沫材料，具体是一种含有泡沫稳定剂和可自由基聚合的亲水烯烃单体与多烯官能团的交联剂交联的聚合物或共聚物。所述水凝胶泡沫材料中添加显影剂，显影剂具体为钽粉。所述内层涂层4成分主要为均质铺设固定在微导管头端3外周面上的颗粒，所述外层涂层5包裹于颗粒外表面。所述微导管头端3的靠近末端位置和微导管主体1的靠近另一端位置各有一个显影标记6。
所述外层涂层5成分可以有三种具体实施例，第一种为与二甲基亚砜接触发生降解且难溶于水的材料，具体可以是3,3’,4,4’-二苯砜四羧酸二酐(DSDA)；第二种为临界点稍高于人体的温度敏感涂料；第三种为水溶性可降解材料，具体可以是淀粉、壳聚糖等。
温度敏感涂料的具体材质可采用生物可降解的聚己内酯和淀粉醋酸酯共混物，再通过过氧化苯甲酰为引发剂进行交联，最终形成熔点在50℃左右的涂料。
水凝胶泡沫材料的具体材质及其配比可采用泡沫稳定剂和自由基可聚合的亲水烯烃单体的聚合体或共聚体(如丙烯酰胺与聚丙烯酸脂钠交联形成共聚体)，其中该单体与约0.1％-10％重量的多烯烃功能交联剂交联；此泡沫基质的特征在于快速胀大和高的水胀率。还可以是多孔的水合聚乙烯醇泡沫(PAF)凝胶、聚甲基丙烯酸-2-羟乙酯(PHEMA)等材质。
以上已对本发明创造的较佳实施例进行了具体说明，但本发明创造并不限于所述的实施例，熟悉本领域的技术人员在不违背本发明创造精神的前提下还可以作出种种的等同的变型或替换，这些等同变型或替换均包含在本申请权利要求所限定的范围内。
Claims (2)
1.一种头端设双涂层的可解脱微导管，包括微导管主体，所述微导管主体的一端连通的导管座，其特征在于，所述微导管主体的另一端还连接有可解脱的微导管头端，所述微导管头端外表面涂覆有可膨胀的内层涂层，所述内层涂层上还密封压紧包覆有可变松散的外层涂层；
所述内层涂层为套于微导管头端外周面的环形结构，所述环形结构设置于微导管头端上靠近所述微导管主体一端的位置；
所述内层涂层为套于微导管头端外周面的环形结构，且多个环形结构之间分隔布置；
所述内层涂层为水凝胶泡沫材料；
所述水凝胶泡沫材料中添加显影剂；
所述内层涂层成分主要为均质铺设固定在微导管头端外周面上的颗粒，所述外层涂层包裹于颗粒外表面；
所述外层涂层成分为一种与二甲基亚砜接触发生降解且难溶于水的材料，或者所述外层涂层为临界点稍高于人体的温度敏感涂料，或者所述外层涂层为水溶性可降解材料。
2.根据权利要求1所述的头端设双涂层的可解脱微导管，其特征在于，所述微导管头端的靠近末端位置和微导管主体的靠近另一端位置各有一个显影标记。
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