CN114916991A - 一种一体式溶栓灌注导管组件 - Google Patents
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Abstract
本发明涉公开了一种一体式溶栓灌注导管组件,由灌注导管管体、旋转式止血阀以及显影标识构成,其中导管管体含同轴的内腔和外腔,外腔中由支杆分割成不同的独立腔室,部分腔室中国含有超声振动装置;且外腔的外表面由若干侧孔构成。该溶栓灌注导管组件,取消使用闭塞导丝,仅使用常用的导丝建立通路,简化了操作流程;由外腔支杆构成的不同的独立腔室,既可以对大的血栓进行超声破碎,再灌注单一药物,也能由各腔室独立输送药物,也可以同时向径向不同方向灌注不同的药物。
Description
技术领域
本发明属于医疗器械技术领域,尤其涉及一种一体式溶栓灌注导管组件。
背景技术
深静脉血栓形成是血液在深静脉内不正常凝结引起的静脉回流障碍性疾病,常发生于下肢。血栓脱落可引起肺动脉栓塞。深静脉血栓和肺动脉栓塞统称为静脉血栓栓塞症,是同种疾病在不同阶段的表现形式,其不良后果能够显著影响患者的生活质量,甚至导致死亡。针对深静脉血栓和肺栓塞的治疗法主要有外科手术、药物治疗和介入疗法。介入疗法包括经导管机械取栓、经导管灌注溶栓等。众多治疗方式中,外科手术创伤大、风险高、患者接受度低,常在急救等紧急情况下应用;全身药物治疗效果好,但溶栓药物全身应用带来较大的出血风险;介入疗法效果好、见效快、侵入性小、安全性有保证,但机械取栓存在损伤血管壁隐患。因此,具有微创、微给药量等特点的经导管直接灌注溶栓作为结合药物与介入手术的治疗方式受到了更多推崇。
现有的灌注导管需要先使用导引导丝建立通路,再沿导丝放入导管,接着撤出导丝送入闭塞导丝封闭给药腔。这样的操作繁琐且耗费时间。目前,用于静脉溶栓的导管均由疏水性聚合物材料制成,容易受到非特异性蛋白质吸附的影响,蛋白质又会吸引血小板和纤维蛋白聚集形成血栓。操作繁琐和材料表面特性增大了溶栓不及时带来的风险,如导管表面血栓形成引入额外血栓、溶血、血栓脱落等,操作流程亟需简化。
因此制备不需要使用闭塞导丝进行封闭,操作简单,使用方面的一体式溶栓的灌注导管是目前介入医学中的一大课题。。
发明内容
本发明的目的是克服现有技术中存在的不足,提供一种一体式溶栓灌注导管组件,其不仅具有很高的柔顺行和抗折性,且取消了闭塞导丝部件,操作简单,耗时短;远端闭塞导丝的取消可以避免远端闭塞导丝击伤血管壁;操作时间的大大缩短可以避免导管表面血栓的形成以及溶栓问题。
为实现上述目的,本发明的技术方案是:提供一种一体式溶栓灌注导管组件,包括灌注导管管体、手持底座(含旋转式止血阀)以及显影标识构成,其特征在于所述的导管管体含同轴的内腔和外腔,所述外腔的远端段外表面含有侧孔,侧孔与导管外腔贯通,与内腔隔绝;所述的手持底座具有中空内腔且与管内腔连通;所述的内腔与外腔同轴但不连通;所述的显影标识镶嵌于中空管外表面;所述外腔的远端段外表面含有侧孔,侧孔与导管外腔贯通,与内腔隔绝。
进一步地,所述的导管的内腔和外腔之间通过远端的封闭隔绝,内外腔之间不贯通,两腔之间并无物质交换。
进一步地,所述的导管为双层结构,其内腔由导管的内层构成,导管同轴的内层和外层之间构成外腔。
进一步地,所述的导管内腔与内腔与止血阀导丝孔连通,提供导引导丝通路,导管外腔与止血阀侧孔连通,提供药物灌注通路。
进一步地,所述的导管外腔中有支杆连接,将外腔沿四周等分为不同的独立腔室。
进一步地,所述的不同的独立腔室之间是互通的。
进一步地,所述的不同的独立腔室之间是隔绝的。
进一步地,所述的部分隔绝的独立腔室中含有超声振动装置。
进一步地,所述的旋转式止血阀为标准式旋转阀、多灌注口旋转式止血阀中的一种;若外腔各腔室在远端连通,则搭配使用标准旋转式止血阀;若外腔各腔室互相隔绝,则根据腔室数量搭配使用特制的多灌注口旋转式止血阀。
进一步地,所述的导管远端外表面带有规则排列的侧孔,且侧孔与导管外腔贯通。
进一步地,所述的显影标识位于侧孔区域两侧。
与现有技术相比,本发明的有益效果:采用一体式溶栓灌注导管组件,取消使用闭塞导丝,仅使用常用的导丝建立通路,简化了操作流程;同时,在外腔中设置不同的支杆结构,使得导管刚柔并济,且支杆结构将外腔划分为不同的腔室,从而既可以灌注单一药物,也可以各腔室独立输送药物,也可以同时向径向不同方向灌注不同的药物。
附图说明
图1 为本发明专利的一体式溶栓灌注导管组件的结构示意图;
图2 为本发明专利图导管管体远端段轴向截面示意图图;
图3 为本发明专利的一体式溶栓灌注导管远端的径向截面示意图;
图4 为本发明专利一体式溶栓灌注导管远端的径向侧孔截面示意图。
具体实施方式
本发明的一体式溶栓灌注导管组件可广泛应用于多种领域,尤其适用于多种医疗器械技术领域,下面通过较佳的实施例来加以说明,当然本发明并不局限于该具体实施例,本领域内的普通技术人员所熟知的一般的替换无疑覆盖在本发明的保护范围内。
本发明专利中所涉及的“近端”是指距离该灌注导管的操作者较近的一端,“远端”是指距离该灌注导管的操作者较远的一端。
实施例1
如图1所示,其为本发明专利的结构示意图,包括灌注导管管体1、标准式旋转式止血阀2以及铂铱合金显影标识3构成。如图2所示,所述的导管管体为双层结构,内层构成了内腔4,内层和外层之间构成了外腔5;如图3所示,所述的导管外腔中有数个支杆6连接,将外腔四周分为不同的独立的腔室7,腔室之间是互相连通的,当将灌注液体经标准旋转止血阀进入时外腔时,液体迅速充盈外腔的各个腔室;所述的手持底座具有中空内腔且与管内腔连通;包含着手持底座里的旋转止血阀与外腔连接;所述的内腔与外腔同轴但不连通,内外腔之间无物质交换;所述的显影标识镶嵌于中空管外表面。如图4所示,所述外腔的远端段外表面含有侧孔8,侧孔与导管外腔贯通,与内腔隔绝;当对外腔施压时,液体通过侧孔流入病变区域进行溶栓。该导管的显影标识位于侧孔区域两侧。
实施例2
如图1所示,一种一体式溶栓灌注导管组件,包括灌注导管管体1、手持底座(含多灌注口旋转式止血阀2)以及显影标识3构成。如图2所示,所述的导管管体为双层结构,内层构成了内腔4,内层和外层之间构成了外腔5;如图3所示,所述的导管外腔中有数个支杆6连接,将外腔四周分为不同的独立的腔室7,腔室之间是互相隔绝的。所述的支杆不仅起到划分各腔室的作用,其也起到支撑外腔的作用,因而能够稳定内外腔的相对位置、各腔室形状,并确保导管的刚性与径向支撑力。同时,部分独立的腔室间含有的超声振动装置,其可以先对血栓进行超声振动破碎;当将灌注的溶栓液体经多灌注口旋转止血阀进入外腔时,不同的灌注液体进入不同的外腔腔室中去;如图4所示,当对外腔各腔室施加压力时,不同的液体通过侧孔8分别流入相应的病变区域进行溶栓或其他治疗。显影标识为多个,分布区各侧孔的两边。所述的述的手持底座具有中空内腔且与管内腔连通;所述的内腔与外腔同轴但不连通;所述的导管的内腔和外腔之间通过远端的封闭隔绝,内外腔之间不贯通,两腔之间并无物质交换。所述的导管为双层结构,其内腔由导管的内层构成,导管同轴的内层和外层之间构成外腔。所述的侧孔按照一定的顺序或者形状规则的排列在导管外层的远端段;所述的导管内腔与止血阀导丝孔(手持底座)连通,提供导引导丝通路,导管外腔与止血阀侧孔连通,提供药物灌注通路。
上述描述仅仅是对本发明专利较佳实施例的描述,并非对本发明专利范围的任何限定,本发明领域的普通技术人员根据上述揭示内容做的任何变更、修饰,均属于权利要求书的保护范围。
Claims (10)
1.一种一体式溶栓灌注导管组件,包括灌注导管管体(1)、旋转式止血阀(2)以及显影标识(3)构成,其特征在于:所述的导管管体含同轴的内腔(4)和外腔(5),所述的内腔与外腔同轴但不连通;所述的显影标识镶嵌于中空管外表面;所述的导管外腔中有支杆(6)连接,将外腔沿四周等分为不同的独立腔室(7);所述外腔的远端段外表面含有侧孔(8),侧孔与导管外腔贯通,与内腔隔绝。
2.根据权利要求1所述的溶栓灌注导管组件,其特征在于:所述的内腔和外腔之间不贯通。
3.根据权利要求1所述的溶栓灌注导管组件,其特征在于所述的导管内腔与止血阀导丝孔连通,导管外腔与止血阀侧孔连通。
4.根据权利要求1所属的溶栓灌注导管组件,其特征在于所述的支杆沿径向分布。
5.根据权利要求1所述的溶栓灌注导管组件,其特征在于不同的独立腔室之间是互通的。
6.根据权利要求1所述的溶栓灌注导管组件,其特征在于不同的独立腔室之间是隔绝的。
7.根据权利要求1所述的溶栓灌注导管组件,其特征在于所述的部分独立腔室中含有声波振动装置。
8.根据权利要求1所述的溶栓灌注导管组件,其特征在于所述的旋转式止血阀为标准式旋转阀、多灌注口旋转式止血阀中的一种。
9.根据权利要求1所述的溶栓灌注导管组件,其特征在于所述的侧孔按规则排列在导管外腔的外表面,并与导管外腔相贯通。
10.根据权利要求1所述的溶栓灌注导管组件,其特征在于所述的显影标识位于侧孔区域的两侧。
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