CN111772710A - 一种治疗颅内动脉瘤的可降解弹簧圈系统 - Google Patents
一种治疗颅内动脉瘤的可降解弹簧圈系统 Download PDFInfo
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Abstract
本发明属于医疗器械领域中的神经介入技术，具体涉及一种治疗颅内动脉瘤的可降解弹簧圈系统。该发明包括由可降解的锌合金金属丝制备的多孔裸金属弹簧圈本体、涂覆于弹簧圈表面的药物涂层、导丝和微导管组成。本发明将可降解金属材料锌应用于弹簧圈的制备，通过调节合金中各金属材料的比例，控制弹簧圈在动脉瘤中的降解速度，提高了弹簧圈植入后的生物相容性。本发明的多孔结构易于促凝药物的附着，在电流和超声刺激下或者在自然降解过程中释放促凝药物到周围的血液和组织中，进一步地促进血管瘤的愈合。本发明所公开的可降解弹簧圈材料丰富易得、安全性好、成本低，适用于大量生产，具有较高应用价值。
Description
技术领域
本发明涉及医疗器械技术领域，特别涉及一种治疗动脉瘤的可降解弹簧圈系统。
背景技术
颅内动脉瘤由血管动脉壁的局部膨出形成。随着动脉瘤的增大，血管壁顺应性降低、张力增加，动脉瘤会发生破裂。破裂的动脉瘤会引起脑血管痉挛、意识障碍、神经功能障碍，甚至发生死亡。目前颅内动脉瘤的手术方式主要有显微外科夹闭术、血管内介入术、颅内外动脉搭桥术。近年来，由于血管介入术创伤小、恢复快等优势，已成为一种具有广泛前景的治疗手段。此外，在一些位置深、开颅风险大、手术难以夹闭或与周围组织不易分离的动脉瘤的治疗中，血管介入术已成为最优选择。血管介入术主要分为单独使用弹簧圈、支架加弹簧圈、球囊扩张血管加弹簧圈治疗。目前主要采用支架加弹簧圈的治疗方式，通过向动脉瘤内置入弹簧圈促进瘤内血栓形成和血管壁重塑，达到治疗动脉瘤的目的。
目前动脉瘤介入治疗采用的弹簧圈主要有金属弹簧圈和水凝胶弹簧圈。金属弹簧圈主要存在以下问题：1. 金属弹簧圈多为钨铂合金材料，其价格昂贵，给患者带来较大的经济负担；2. 钨铂合金重量较大，大量的填塞弹簧圈容易引起占位效应或者质量效应，对周围组织和血管有压迫影响；3. 长期存在于动脉瘤内的弹簧圈会因松弛使部分脱出，在血管内形成血栓；4. 金属材料会产生金属虚像，影响后续随访治疗。因此，一种材料丰富、价格便宜、可降解的金属弹簧圈具有较好的应用前景。
专利可降解医用弹簧圈（201510954601 .0）公布了一种镁合金可降解弹簧圈，其合金材料主要为镁锌锰钙，镁所占比例在80%以上，镁合金存在降解速度较快的问题，无法保证镁合金降解后内膜完全修复。且相对于镁，锌元素在神经系统、新陈代谢、内皮细胞生长中发挥重要作用，铁元素对血液系统、铜元素对脑细胞发育及铁的吸收均有重要作用。
专利201720368473 .6公开了一种血管内介入医学用可降解弹簧圈，使用医用可降解缝合线体在直线芯棒上绕制成螺旋弹簧来实现短暂性栓塞，如产后子宫出血、急性消化道出血的的应急控制；受损区或手术区供血动脉短时供血控制等情形。在这些紧急情况消除后，血管恢复通畅。此种方法所制作的弹簧圈支撑力差，无法短时间内消除血管瘤出血风险。且降解速度过快，有堵塞不足和复发的风险。
专利201920039718.X公布了一种镁合金可降解弹簧圈，便于将弹簧体稳定的导入血管或者从血管中回收，提高了弹簧体的输送和回撤能力。但此种弹簧圈由镁合金制成，未给出镁合金的成分组成，且不含药物涂层，无法快速形成血栓。
发明内容
针对现有技术中的不足，本发明提供了一种治疗颅内动脉瘤的可降解弹簧圈系统，主要解决弹簧圈金属材料昂贵、弹簧圈的占位效应以及快速血栓化的问题。
本发明一种治疗颅内动脉瘤的可降解弹簧圈系统包括：包裹导丝和弹簧圈的微导管、导丝、由锌铁铜合金制备的金属弹簧圈本体和弹簧圈表面的药物涂层。
优选地，本发明一种治疗颅内动脉瘤的可降解弹簧圈中，弹簧圈本体锌铁铜合金的质量百分比分别为锌92%，铁5%，铜的成分占比2%。
优选地，本发明一种治疗动脉瘤的可降解弹簧圈中，金属丝直径为0.04，圈状结构直径为0.03 mm。
优选地，本发明一种治疗动脉瘤的可降解弹簧圈中，导丝为不锈钢材质，末端与可降解弹簧圈相连接。在植入到靶位置后，通直流电促进药物涂层的释放，并通过电解反应释放可降解弹簧圈，使其与导丝分离。
优选地，本发明一种治疗颅内动脉瘤的可降解弹簧圈中，所述药物涂层包含载药物载体和促凝药物成分。
优选地，本发明一种治疗颅内动脉瘤的可降解弹簧圈中，载药载体包括金箔微球、聚乙二醇-聚乳酸共聚物、纳米粒、中空微球和脂质体的一种或多种组成。
优选地，本发明一种治疗颅内动脉瘤的可降解弹簧圈中，药物涂层中包含促凝血物质为蛇毒血凝酶、维生素K、冻干人凝血因子Ⅷ、凝血酶原复合物、凝血酶和冻干人纤维蛋白原、氨甲苯酸、氨甲环酸、抑肽酶和氨基己酸、安络血和酚磺乙胺等一种或多种。
优选地，本发明一种治疗动脉瘤的可降解弹簧圈中，所述药物涂层在电流或超声刺激下破裂快速释放促凝药物。
与现有技术相比，本发明具有以下优点：
（1）本发明利用锌合金材料替代钨铂合金，解决材料成本问题，由于锌铁铜元素均对人体新陈代谢有重要影响，可降解弹簧圈在降解后的元素可为人体所利用；
（2）所选材料为锌铁铜合金，可在体内完全降解无残留，避免了占位效应，不会产生金属伪影进而影响后期的影像学随访；
（3）电流或超声刺激后，药物涂层中的促凝物质释放，促进血栓的快速形成，避免了颅内血管瘤急性出血。
附图说明
图1可降解弹簧圈系统横截面结构示意图。其中1为包裹导丝和弹簧圈的微导管，2为导丝，3为载药的可降解弹簧圈，31为弹簧圈表面的药物涂层，32为弹簧圈的多孔表面，33为弹簧圈本体。
图2为可降解弹簧圈填满动脉瘤示意图。其中4为血管，5为动脉瘤，6为植入动脉瘤的可降解弹簧圈。
具体实施方式
下面结合实施方式对本发明的进行具体描述。
本发明提出了一种治疗颅内动脉瘤的可降解弹簧圈系统。如图1和图2所示，该可降解医用弹簧圈包括：1微导管、2导丝、3裸金属弹簧圈本体，其由锌合金材料制备；弹簧圈表面经多孔处理形成32多孔表面；药物涂层31被覆于所述裸金属弹簧圈本体及多孔孔隙的外表面，该药物涂层31包含促凝药物。
上述治疗动脉瘤的可降解弹簧圈本体由可锌合金制备，具体为锌铁铜合金，可降解弹簧圈的质量百分比组成中，锌的成分介于90%-95%，铁的成分介于3%-8%，铜的成分占比1%-2%。锌元素在神经系统、新陈代谢、内皮细胞生长中发挥重要作用，铁元素对血液系统、铜对脑细胞发育及铁的吸收均有重要作用。本发明克服本领域技术偏见，利用锌合金柔软性高、可降解及讲解产物无毒的特点，以锌为基础材料应用于医学领域。
通过调整锌合金中各种元素(锌、铁、铜)的比例，使锌合金制备的可降解弹簧圈满足治疗动脉瘤的要求（硬度、柔韧性、降解时间等）。经过实验锌合金材料按以下质量百分比进行配比可满足实用性要求。
表1不同锌合金材料质量百分比组成(％)
| 锌 | 铁 | 铜 |
| 95 | 4 | 1 |
| 90 | 8 | 2 |
| 93 | 6 | 1 |
上述锌合金材料通过机器拉丝形成直径为0 .03～0 .05mm的金属丝。金属丝通过火焰喷涂法、电镀法、化学腐蚀法、机械加工法、烧结法、丝网覆盖法、复合法、鋳造法、沉积法形成多孔表面。
上述多孔表面丝状材料经处理模具形成直径介于0 .30～0 .40mm的弹簧圈结构。药物涂层10包括促凝药物。药物涂层通过浸润或喷涂涂覆于弹簧圈表面，所述促凝物质为蛇毒血凝酶、维生素K、冻干人凝血因子Ⅷ、凝血酶原复合物、凝血酶和冻干人纤维蛋白原、氨甲苯酸、氨甲环酸、抑肽酶和氨基己酸、安络血和酚磺乙胺。促凝药物在弹簧圈填充动脉瘤后在电流或超声刺激下释放，其释放速率可通过调节电流大小或超声频率进行调控，药物释放时会在动脉瘤内快速形成血栓，不会流溢出动脉瘤在血管内形成血栓。
在弹簧圈到达动脉瘤后，通过导丝通直流电，弹簧圈吸引带负电荷的血液成分(红细胞、白细胞、血小板等)发生电凝，在动脉瘤内形成血栓，同时弹簧圈与不锈钢导丝相连部分因电解而溶断，弹簧圈解脱留于动脉瘤中。
需要说明的是，裸金属弹簧圈本体表面被覆的药物涂层并非本发明所必须的，在某些情况下也可以省略。
实施例1：
本实施例一种治疗动脉瘤的可降解弹簧圈系统包括：1微导管、2不锈钢导丝、3金属弹簧圈本体以及涂覆于金属弹簧圈表面的31药物涂层。33金属弹簧圈本体由锌铁铜材料制成，质量百分比为95%锌，4%铁，1%铜。该金属弹簧圈本体的直径是0 .30～0 .40mm。根据弹簧柔软度的不同要求，弹簧丝径的最佳范围是0 .03～0 .05mm。
金属丝表面经多孔处理形成32多孔表面。图2为经导管输送系统释放后可降解医用弹簧圈在释放状态填满动脉瘤或动静脉畸形内局部可降解医用弹簧圈的放大示意图。促血栓药物(例如蛇毒血凝酶、维生素K)由超声喷涂涂敷于可降解弹簧圈表面，载药量为1~500 μg/cm2.
图2为本实施例可降解医用弹簧圈填满动脉瘤内的示意图。
当这些可降解医用弹簧圈经由导管输送系统植入动脉瘤中后，可降解医用弹簧圈表面药物涂层内的促血栓药物(例如蛇毒血凝酶、维生素K)会在电刺激下释放出来，通过控制电流大小控制药物失访速度，在动脉瘤快速的产生血栓，直到最后将整个动脉瘤完全栓塞，当病变区被栓塞后，实际能够溢出病变区的促血栓药物很少，即使有一些，也会被流动的血液迅速的稀释到更低的浓度，因此不会对血管的其他部位造成堵塞。
在可降解医用弹簧圈植入动脉瘤一段时间内(30～45天)，裸金属弹簧圈本体表面的可降解载体在体内降解后的最终产物是二氧化碳和水，且可降解载体的降解产生的低聚物会促进血栓转化为动脉瘤愈合所需的纤维细胞组织，从而加速动脉瘤的愈合。同时裸金属弹簧圈本体的金属成分锌离子会缓慢释放入血液，并通过肝肾循环代谢。
实施例2：
本实施例可降解医用弹簧圈与第一实施例大体相同，区别仅在于裸金属弹簧圈本体由锌铁铜合金材料制备。
在该锌铁铜合金材料中，各种组分的质量百分比组成为：锌的成分为90％；铁的成分为8％；铜的成分为2％。
实验证明，该可降解医用弹簧圈满足应用要求。
实施例3：
本实施例可降解医用弹簧圈与第一实施例大体相同，区别仅在于裸金属弹簧圈本体由锌铁铜合金材料制备。
在该锌铁铜合金材料中，各种组分的质量百分比组成为：锌的成分为93％；铁的成分为6％；铜的成分为1％。
实验证明，该可降解医用弹簧圈满足应用要求。
实施例4：
本实施例可降解医用弹簧圈与第一实施例大体相同，区别仅在于药物涂层使用浸渍方式涂敷于可降解弹簧圈表面，药物浓度为1~500 μg/cm2。
Claims (9)
1.一种治疗颅内动脉瘤的可降解弹簧圈系统，其特征在于，包括：包裹导丝和弹簧圈的微导管、导丝、金属弹簧圈本体和药物涂层，裸金属弹簧圈本体是由锌铁铜合金组成的螺旋弹簧，具有多孔表面；药物涂层均匀涂覆于所述裸金属弹簧圈本体及孔隙的外表面。
2.根据权利要求1所述治疗颅内动脉瘤的可降解弹簧圈系统，其特征在于，所属弹簧圈圈状结构直径介于0.20～0 .40mm之间。
3.根据权利要求1所述治疗颅内动脉瘤的可降解弹簧圈系统，其特征在于，所述弹簧圈本体由特殊配方的金属丝材料加工制成。
4.根据权利要求3所述治疗颅内动脉瘤的可降解弹簧圈系统，其特征在于组成弹簧圈本体的金属丝中锌铁铜合金的质量百分比（wt%）分别为：锌90%-95%，铁3%-8%，铜1%-2%。
5.根据权利要求3所述治疗颅内动脉瘤的可降解弹簧圈，其特征在于，所述金属丝直径介于0 .03～0 .05mm之间。
6.根据权利要求1所述的治疗颅内动脉瘤的可降解弹簧圈系统，其特征在于，所述裸金属弹簧圈本体表面具有多孔结构。
7.根据权利要求1所述的治疗颅内动脉瘤的可降解弹簧圈系统，其特征在于，所述药物涂层由超声喷涂、激光镂空、浸涂、喷涂、热喷涂、静电涂敷、溶胶凝胶和超临界液态等工艺中的一种或多种涂覆于可降解弹簧圈表面。
8.根据权利要求1所述的治疗颅内动脉瘤的可降解弹簧圈系统，其特征在于，所述药物涂层所涂覆的促凝药物可以包含但不限于蛇毒血凝酶、维生素K、冻干人凝血因子Ⅷ、凝血酶原复合物、凝血酶和冻干人纤维蛋白原、氨甲苯酸、氨甲环酸、抑肽酶和氨基己酸、安络血和酚磺乙胺的一种或多种。
9.根据权利要求1所述的治疗颅内动脉瘤的可降解弹簧圈系统，其特征在于，所述药物涂层的促凝药物可在电流、超声刺激下快速释放，或在自然扩散和降解过程中缓慢释放。
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| CN112617949A (zh) * | 2020-12-31 | 2021-04-09 | 微创神通医疗科技（上海）有限公司 | 弹簧圈及其制备方法 |
| CN112617949B (zh) * | 2020-12-31 | 2022-04-15 | 神遁医疗科技(上海)有限公司 | 弹簧圈及其制备方法 |
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