CN109481085A - 一种施加有药物的介入瓣膜 - Google Patents

一种施加有药物的介入瓣膜 Download PDF

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CN109481085A
CN109481085A CN201811589440.XA CN201811589440A CN109481085A CN 109481085 A CN109481085 A CN 109481085A CN 201811589440 A CN201811589440 A CN 201811589440A CN 109481085 A CN109481085 A CN 109481085A
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valve
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姜楠
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TIANJIN THORACIC HOSPITAL
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Abstract

本发明涉及一种介入瓣膜。本发明的瓣膜由瓣架部分、瓣叶部分和密封裙部分构成；其中瓣架和/或密封裙布上施加有药物，用于抑制介入瓣之后发生的并发症，或者用于提高植入后的康复等，进而降低植入后并发症和提高提高术后效果。

Description

一种施加有药物的介入瓣膜
技术领域
本发明属于医疗器械技术领域，具体涉及一种介入瓣膜。
背景技术
瓣膜疾病是一种常见的心脏瓣膜疾病，随着年龄的增加发病率逐渐升高。对于病变瓣膜，通常采用外科手术进行人工心脏瓣膜，但部分患者由于年龄大等原因不可接受外科手术，针对此类病人可采用介入瓣膜进行，因其不需要开胸，具有创伤小、康复快等优点，受到越来越广泛的关注和重视。
介入瓣膜最近几十年已取得了很好的发展，但植入后瓣周漏及其他并发症仍是影响其术后结果的主要问题，尤其对于严重钙化的病人，瓣周漏的发生率则更高。进而直接降低了瓣膜植入后的远期疗效，增加了术后再次手术和死亡的发生率，并限制其向低危患者等更广泛人群的应用。
目前对于降低瓣膜瓣周漏的设计方式，已出现了很多设计和发明；但因为其采用结构的和特定的方式，总会存在一些问题，比如增加瓣膜的输送直径、瓣膜植入后降低瓣周漏不彻底、或者植入后瓣架的支撑力变弱等。
同时瓣膜植入后也存在很多其他相应的并发症，如可能存在瓣膜植入部位及瓣膜上对应的血栓。血栓的产生会对瓣膜植入后的临床效果产生影响，也需要对应的方式降低此类并发症的发生。
发明内容
本发明提供一种介入瓣膜，所述瓣膜由瓣架部分、瓣叶部分和密封裙部分构成；其中瓣架和/或密封裙布上被施加有药物，用于抑制介入瓣之后发生的并发症，或者用于提高植入后的康复等，进而降低植入后并发症和提高提高术后效果。
进一步地，所述药物是具有抗凝效果的药物、用于降低介入瓣植入后的凝血和血栓；或者是具有抑制细胞增生的药物，或者是具有促进周围钙化组织溶解或软化的药物。
进一步讲所涂敷的药物仅位于需要发生作用的一面。
进一步讲所述涂敷的抗凝药物位于与血液接触面；涂敷的组织增生药物和促进钙化组织溶解或软化的药物位于与血管接触面。
在实施过程中所述药物可混合在缓释涂层内，然后将整个涂层涂敷在所述的瓣架和/或密封裙上。
并且在所述瓣架药物涂敷面具有多个密的凹陷，用于接受药物或增加涂层附着性。
进一步讲所述缓释涂层具有增加涂层与瓣架和/或密封裙粘结能力的助剂。
所述抗凝药物为华法林，阿斯匹林、肝素、磷酰胆碱，硅炭合金、炭化物等。所述抑制组织增生的为雷帕酶素、紫杉醇及相关同族或衍生物。
附图说明
图1为根据本发明一实施例的介入瓣膜的结构示意图。
具体实施方式
为使本发明的目的、技术方案和优点更加清楚，下面将结合本发明的附图和实施例，对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。
如图1示，本发明的介入瓣膜由瓣架1、瓣叶2和密封裙3构成；其中密封裙(密封裙布)通过缝线4固定在对应的瓣架上，所使用的缝线可用医用植入类缝线，缝线在满足要求前提下尽可能的细。瓣叶也同样通过缝线固定到对应的密封裙和/或瓣架上。密封裙用于防止瓣周漏。
介入瓣膜植入体内通常会发生血栓，会促使周围组织生产，压迫传导束产生传导束阻滞，影响病人的术后。本发明中，在介入瓣膜中施加药物，让药物在植入介入瓣膜后发挥作用，抑制植入后的并发症，提高植入后的康复等。
为了解决本发明的问题，所施加药物优选为抗凝药物，典型的例子肝素钠、肝素钙、肝素、伊诺肝素、替他肝素、阿地肝素、华法林、双香豆素、硝酸香豆素、枸橼酸钠、水蛭素、阿加曲班、阿斯匹林等。
本发明中被施加的药物还可以包含具有抑制细胞增生的药物，该药物可以抑制细胞的增殖，减少对传导束的压迫，降低传导束阻滞的发生。但对于涂敷的药物，一定考虑到采用适当的剂量，防止细胞在此处抑制过于庞大，或者失去控制，进而产生其他负面效应。可以用于本发明的抑制细胞增生的药物的例子包括但不限于为雷帕酶素、紫杉醇及相关同族或衍生物。
还可以施加能够促进周围钙化组织溶解或软化的药物。在病变部位或者附近存在的钙化组织具有一定的硬度，往往会阻碍植入的瓣架恢复原始形态，造成介入瓣膜与机体组织之间产生间隙。施加该药物后，钙化组织被溶解或者软化，消除了钙化组织对瓣架形变的阻碍，有利于瓣架与瓣环的贴合，从而降低相应的瓣周漏的发生率。
前述药物包括目前尚未上市，但后续上市能够具备此类功能，且可进行涂敷的所有药物。
药物可以施加在瓣架上，也可以施加在密封裙上，优先施加在密封裙上。在一种具体实施方式中，通过浸渍的方式施加药物在密封裙布上。具体而言，用密封裙布浸渍含有药物的溶液，然后干燥该密封裙布即可。另一种实施方式中，将药物制成浸膏状组合物，采用涂布的方式施加到密封裙布上。为了增加药物的附着力，可以在浸膏组合物中引入可药用粘结剂，例如淀粉、糊精、麦芽糖、阿拉伯胶、明胶、甲基纤维素、羧甲基纤维素钠、羟丙基纤维素、聚乙烯吡咯烷酮等。
在药物被施加在瓣架的情况下，优选将药物做成可涂布组合物，在瓣架上形成涂层。为了增加药物在瓣架上的附着力，优选使瓣架具有粗糙的表面，例如将瓣架放置在具有腐蚀性的材料中腐蚀预定的时间，或者在瓣架上形成密集分布的凹点，后者类似于冠脉支架的微坑设计或麻坑设计。另一种优选方式中，也向该涂层组合物中引入前述粘结剂。
在以涂层形式施加药物于瓣架的情况下，优先将药物涂敷于瓣架的需要发生药物作用的一面。例如所涂敷为抑制组织生长的药物或促进钙化组织溶解或软化的药物的时候，将药物施加在与血管接触的面。如果是抗凝药物，则优先涂敷于与血液接触的一面。
在实施过程中，药物可混合在缓释涂层内，然后将整个涂层涂敷在所述瓣架和/或密封裙上。此方式经常用于带药血管支架的设计和加工中，其工艺和方案可参照相关带药支架的方式进行。另外瓣架药物涂敷面可以具有多个密的凹陷，用于接受药物或增加涂层附着性。类似于冠脉支架的微坑设计或麻坑设计。
在药物被施加于瓣架的情况下，还可以将瓣架制成多孔结构，然后将药物施加在多孔结构的瓣架中。该多孔结构的瓣架可以以泡沫陶瓷形成，也可以是高分子材料经过高温碳化后得到的碳骨架材料，可以应用的高分子材料包括酚醛树脂、聚氨酯等。在后一种情况下，将酚醛树脂或者聚氨酯形成瓣架型坯，然后在缺氧条件进行热处理，高分子链被碳化。在获得前述多孔结构的瓣架后，以包含药物的溶液浸渍瓣架，由于瓣架具有高的比表面积，对药物具有很好的吸附作用
作为本发明的典型实施方式，尤其是采用多孔结构的瓣架的情况下，介入瓣膜在投放杨业渠道前，药物即被施加在好，医生只需简单地植入就可以。作为该实施方式的变型，可以在使用前，根据病人的病情现场配制适宜的药液，将瓣膜浸泡在药液中一段时间，在需要的情况下，进行适当干燥即可。

Claims (11)

1.一种介入瓣膜，其特征在于，所述瓣膜由瓣架、瓣叶和密封裙部分构成，其中所述瓣架和/或密封裙布上被施加有药物。
2.根据权利要求1所述的介入瓣膜，其特征在于，所述药物是抗凝药物，用于降低介入瓣膜植入后的凝血和血栓。
3.根据权利要求1所述的介入瓣膜，其特征在于，所述药物是抑制细胞增生的药物或者促进钙化组织溶解或软化的药物。
4.根据权利要求2所述的介入瓣膜，其特征在于，所述抗凝药物被施加在与血液接触的一面。
5.根据权利要求3所述的介入瓣膜，其特征在于，所述药物被施加在与血管接触的一面。
6.根据权利要求1所述的介入瓣膜，其特征在于，所述药物被浸渍在所述瓣架和/或密封裙上。
7.根据权利要求1所述的介入瓣膜，其特征在于，所述药物被涂布在所述瓣架和/或密封裙上。
8.根据权利要求7所述的介入瓣膜，其特征在于，所述药物被结合在缓释涂层内。
9.根据权利要求1所述的介入瓣膜，其特征在于，所述药物被施加在瓣架上，所述瓣架被施加药物的面具有多个凹陷，用于接受药物或增加涂层附着性。
10.根据权利要求1所述的介入瓣膜，其特征在于，所述瓣架是泡沫陶瓷，或者多孔碳材料材质，所述药物被施加在该瓣架的多孔中。
11.根据权利要求10所述的介入瓣膜，其特征在于，所述多孔碳材料的瓣架被结合有缓释材料。
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