CN108939257B - 一种头端可解脱球囊微导管 - Google Patents
一种头端可解脱球囊微导管 Download PDFInfo
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Abstract
本发明涉及一种头端可解脱球囊微导管,包括微导管主体,所述微导管主体的一端连通导管座,所述微导管主体的另一端还连接有可解脱的微导管头端;所述微导管主体外同轴设置有套管,所述套管两端分别连通至导管座和微导管主体上的可充盈球囊。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,具体是一种头端可解脱球囊微导管。
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,提供一种头端可解脱球囊微导管,包括微导管主体,所述微导管主体的一端连通导管座,所述微导管主体的另一端还连接有可解脱的微导管头端;所述微导管主体外同轴设置有套管,所述套管两端分别连通至导管座和微导管主体上的可充盈球囊。
导管座用于转接和固定套管、微导管主体,套管与微导管主体形成了一种同轴双腔结构,使得导管座可以向套管与微导管主体之间注射或抽取充盈液,并将导引导丝或注射液体进入微导管主体,同时确保充盈液不会泄露或与其他物质混杂;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供血动脉,一般设置为管状或杆状。
优选的,所述可充盈球囊为套于微导管主体外周面的环形结构,所述环形结构设置于微导管主体另一端的附近位置。
套于微导管主体外周面的环形结构是指在微导管主体的周向上能形成连续的膨胀体。
优选的,所述可充盈球囊由聚氨酯材质制成,所述可充盈球囊及所述套管的外表面均覆有亲水涂层。
所述亲水涂层与充盈球囊、套管表面的结合牢固不易脱落,一般采用对血管无刺激性的成分。
优选的,还包括两端用于过盈配合的套筒,所述微导管主体与微导管头端分别通过插入套筒两端形成连接;所述套筒与微导管主体的过盈值小于所述套筒与微导管头端的过盈值。
该套筒类似于袖套结构,套筒两端的管径不同,从而配合微导管主体与微导管头端形成不同的过盈值。其过盈值设置应保证可以通过体外牵拉微导管使微导管主体从该处解脱开。
优选的,所述套管、可充盈球囊、套筒一体成型制作。
一体成型制作,保证三个部件间的接口平顺性,同时方便亲水涂层的涂覆。
优选的,还包括两端用于间隙配合的套筒,所述微导管主体与微导管头端分别插入套筒两端;所述套筒远端边缘与微导管头端之间填充有接触二甲基亚砜发生缓慢降解的黏合剂,或者所述套筒近端边缘与微导管主体之间填充有接触二甲基亚砜发生缓慢降解的黏合剂。
采用远端或近端任一端配合黏合剂后,另一端固定连接,从而避免套筒意外滞留。
二甲基亚砜(DMSO)实际上是栓塞剂(Onyx胶)的溶剂,如果胶发生反流,其溶剂DMSO也会跟着反流,此时黏合剂溶解于二甲基亚砜(DMSO),即可使微导管能够在解脱部位断开。
优选的,所述微导管主体在设置可充盈球囊位置长度方向上的两侧设有显影标记。
本处所指长度方向,指的是在微导管主体的长度方向。亦即该处的显影标记间隔设置,其间隔间隙大致等于可充盈球囊的宽度。显影标记可通过一定手段在体外进行清晰的观察。
优选的,所述可充盈球囊的充盈液中含有造影剂。
造影剂配合一定手段可在体外进行清晰的观察
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。靠近这些末端位置设置有显影标记。
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,从而提升其在体外的可识别角度。
增加球囊的设计,在导管到位后,充盈球囊,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。无需超选两根微导管并填塞弹簧圈或注射医用胶,简化治疗操作过程,降低操作复杂程度,提高治疗的安全性和有效性。同时减少了微导管、弹簧圈等血管内器具的应用,降低患者的经济负担。同轴布置,能提升有效使用空间,降低系统整体的体积。
环形结构构造,将微导管主体的外周面无间隙地包裹,从而避免膨胀后微导管主体本身与血管壁接触,降低相关并发症的发生;而环形结构设置于微导管主体上靠近所述微导管头端一端的位置,降低了胶的无效使用量。
球囊材料选择聚氨酯,特点是更薄且耐用;球囊及微导管表面均有亲水涂层,令其表面光滑增加整体推送性及跟踪性,同时确保了球囊在血管内的高顺应性。
两端用于过盈配合的套筒设计,在确保解脱时不会产生散落部件的基础上,提升其运行中的可靠性。
套管、可充盈球囊、套筒一体成型制作的情况下,能够使得各个连接处不会产生多余棱角。同时方便零件拼装、消毒。
两端中任意一端用于间隙配合并配合黏合剂,使得微导管能够在解脱点在指定时段内自动断开,降低整体操作步骤和操作难度。解脱点填充有接触二甲基亚砜(DMSO)发生缓慢降解的黏合剂,当注射Onyx胶反流至解脱部位时,连接处的黏合剂便会发生缓慢溶解,这使得微导管能够在解脱点断开。
微导管主体在设置可充盈球囊位置长度方向上的两侧设有显影标记,用于判断血管内球囊的位置。
添加造影剂的作用是用于判断血管内球囊的充盈程度。当充盈液流入时,充盈液一般是先填充球囊远离微导管头端的一侧,然后逐渐填充至靠近微导管头端的一侧,填充的越多显影越明显。球囊在血管内的高顺应性也能进一步配合显影标记提升其显示精确程度。
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的作用是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。
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;
图2为本发明的可充盈球囊及其相关结构第一种实施例示意图;
图3为本发明的可充盈球囊及其相关结构第二种实施例示意图。
其中:
1-微导管主体 11-套管 2-导管座
3-微导管头端 4-可充盈球囊 5-套筒
6-显影标记 7-黏合剂
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至图2所示的一种头端可解脱球囊微导管第一种实施例,包括微导管主体1,所述微导管主体1的一端连通导管座2,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;所述微导管主体1外同轴设置有套管11,所述套管11两端分别连通至导管座2和微导管主体1上的可充盈球囊3。所述可充盈球囊3为套于微导管主体1外周面的环形结构,所述环形结构设置于微导管主体1另一端的附近位置。所述可充盈球囊3由聚氨酯材质制成,所述可充盈球囊3及所述套管11的外表面均覆有亲水涂层。还包括两端用于过盈配合的套筒5,所述微导管主体1与微导管头端3分别通过插入套筒5两端形成连接;所述套筒5与微导管主体1的过盈值小于所述套筒5与微导管头端3的过盈值。所述套管11、可充盈球囊4、套筒5一体成型制作。所述微导管主体1在设置可充盈球囊位置长度方向上的两侧设有显影标记6。所述可充盈球囊4的充盈液中含有造影剂。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。
根据图3所示的一种头端可解脱球囊微导管第二种实施例,还包括两端用于间隙配合的套筒5,所述微导管主体1与微导管头端3分别插入套筒5两端;所述套筒5远端边缘与微导管头端3之间填充有接触二甲基亚砜发生缓慢降解的黏合剂7,所述套筒5近端边缘与微导管主体1之间填充有不降解的黏合体从而实现固定。
所述亲水涂层可采用聚甲基乙烯基醚共聚马来酸和聚碳化二亚胺在球囊比表面进行交联的形式涂覆,参考刘艳等报道在《应用化工》2013年第1期上的方法;其他适宜的材料可以是Boston Scientific Corporation出品的BioslideTM润滑涂层、DSM Biomedical出品的亲水性润滑涂料等。
接触二甲基亚砜(DMSO)发生缓慢降解的黏合剂可采用α-氰基丙烯酸正丁酯为主要成分的黏合剂等形式。
适用于包括各种脑血管畸形、颅内肿瘤以及其他需要通过注射液体栓塞剂闭塞动脉或畸形血管团的各类血管病的栓塞治疗,特别适用于近端供血动脉直径为2~5mm的AVM病例。
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 (1)
1.一种头端可解脱球囊微导管,包括微导管主体,所述微导管主体的一端连通导管座,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;所述微导管主体外同轴设置有套管,所述套管两端分别连通至导管座和微导管主体上的可充盈球囊;
所述可充盈球囊为套于微导管主体外周面的环形结构,所述环形结构设置于微导管主体另一端的附近位置;
所述可充盈球囊由聚氨酯材质制成,所述可充盈球囊及所述套管的外表面均覆有亲水涂层;
还包括两端用于过盈配合的套筒,所述微导管主体与微导管头端分别通过插入套筒两端形成连接;所述套筒与微导管主体的过盈值小于所述套筒与微导管头端的过盈值;所述套管、可充盈球囊、套筒一体成型制作;
或,还包括两端用于间隙配合的套筒,所述微导管主体与微导管头端分别插入套筒两端;所述套筒远端边缘与微导管头端之间填充有接触二甲基亚砜发生缓慢降解的黏合剂,或者所述套筒近端边缘与微导管主体之间填充有接触二甲基亚砜发生缓慢降解的黏合剂;
所述微导管主体在设置可充盈球囊位置长度方向上的两侧设有显影标记;
所述可充盈球囊的充盈液中含有造影剂;
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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