CN115105158B - 一种封闭电极脉冲球囊扩张导管 - Google Patents
一种封闭电极脉冲球囊扩张导管 Download PDFInfo
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Abstract
本发明公开了一种封闭电极脉冲球囊扩张导管,属于医疗器械技术领域,该一种封闭电极脉冲球囊扩张导管,包括导管部件以及设置在所述导管部件远端的球囊部件,所述导管部件和所述球囊部件形成有填充区间;电极组件,所述电极组件包括外电极部件、内电极部件、绝缘部件和圆孔部件,所述内电极部件同所述圆孔部件共同形成一外端开口的电场区间。通过在圆孔部件的外侧端设置薄膜部件,即通过薄膜部件对圆孔部件开口的外侧端进行封堵,从而形成一近似封闭的电场区间,当球囊导管处于治疗态时阻止填充区间内的液体进入电场区间,能够在不增加球囊导管外径的条件下实现电场区间的防水,保证外电极部件和内电极部件在放电时的安全性和稳定性。
Description
技术领域
本发明属于医疗器械技术领域,具体涉及一种封闭电极脉冲球囊扩张导管。
背景技术
冠状动脉粥样硬化性心脏病(冠心病)可采用药物、介入和外科手术治疗,其中,介入治疗以其疗效显著、创伤小、患者痛苦少,总体疗效与冠状动脉旁路移植术相同,且明显优于单纯药物治疗,日益受到临床医生和患者的青睐,已成为冠心病治疗中不可或缺的一种重要手段,球囊导管是手术中常常用到的器具,如专利文献CN104582597A公开了一种具有多个冲击波源的冲击波球囊导管,利用冲击波源实现病变位置的治疗。
现有球囊导管中超声波发生器作用的电极的外径较大,当冠脉钙化病变处可供导管和球囊通过的间隙较小时,导管通过困难,球囊在撑开时也可能无法完全撑开并贴合在血管内壁上,起不到应有的治疗作用,通过降低电极的外径可以改善这一问题,但是由于电极外径的减小,外电极孔中本来用于在外电极和内电极放电时作为介质的空气可能会被推出外电极孔,导致造影液渗入引发短路,使得导管失去作用。
发明内容
本发明的目的在于提供一种封闭电极脉冲球囊扩张导管,以解决上述背景技术中提出现有的球囊导管在使用过程中的问题。
为实现上述目的,本发明提供如下技术方案:一种封闭电极脉冲球囊扩张导管,包括导管部件以及设置在所述导管部件远端的球囊部件,所述导管部件和所述球囊部件形成有填充区间;
电极组件,所述电极组件包括外电极部件、内电极部件、绝缘部件和圆孔部件,所述内电极部件同所述圆孔部件共同形成一外端开口的电场区间;
薄膜部件,包覆在所述圆孔部件的外侧端,当球囊导管处于治疗态时,所述薄膜部件对所述圆孔部件的外侧端进行封堵,阻止所述填充区间内的液体进入所述电场区间,并以所述薄膜部件作为声波的传递介质实现治疗。
优选的,所述薄膜部件的边缘通过粘接固定在所述外电极部件上的粘接区域。
优选的,所述薄膜部件由玻璃纤维结合纳米材料制成。
优选的,所述薄膜部件由胶质物制成。
优选的,所述胶质物以脱水态进行输送,当所述球囊导管处于治疗态时变成含水态从而在所述圆孔部件的外侧端形成保护膜。
优选的,所述胶质物是明胶。
优选的,所述薄膜部件由承载了过氧化钠或干冰的薄膜构成。
优选的,所述薄膜部件以一般态进行输送,当所述球囊部件处于治疗态时遇水释放气体阻止液体进入所述电场区间。
优选的,所述外电极部件和内电极部件的材料包括铂铱合金。
优选的,所述球囊部件的材料包括尼龙。
与现有技术相比,本发明的有益效果是:
通过在圆孔部件的外侧端设置薄膜部件,即通过薄膜部件对圆孔部件开口的外侧端进行封堵,从而形成一近似封闭的电场区间,当球囊导管处于治疗态时阻止填充区间内的液体进入电场区间,能够在不增加球囊导管外径的条件下实现电场区间的防水,保证外电极部件和内电极部件在放电时的安全性和稳定性。
附图说明
图1为本发明球囊导管治疗态结构示意图;
图2为本发明球囊导管输送态结构示意图;
图3为本发明薄膜部件结构示意图;
图4为本发明电极组件结构示意图。
图中:100、导管部件;200、球囊部件;201、填充区间;300、电极组件;301、外电极部件;302、内电极部件;303、绝缘部件;304、圆孔部件;304a、第一区段;304b、第二区段;305、电场区间;400、薄膜部件;401、粘接区域。
具体实施方式
下面将结合本发明实施例中的附图,对本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅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。
参照图1-4,一种封闭电极脉冲球囊扩张导管(以下简称球囊导管),包括导管部件100以及设置在导管部件100远端的球囊部件200,球囊部件200和导管部件100之间形成有填充区间201,通过向该填充区间201内填充液体(如造影液)使球囊部件200进行扩张,对应的,该球囊导管具有输送态和治疗态两种形态,当球囊导管处于输送态时,填充区间201内没有注入填充液,球囊部件200未进行扩张,此时球囊导管整体的直径偏小,便于其在血管中进行移动,当球囊部件200处于治疗态时,填充区间201内充满了填充液,球囊部件200进行扩张并和血管的外壁进行接触,同时该球囊导管还包括电极组件300,该电极部件设置在该填充区间201内,且沿导管部件100的长度方向进行布置,通过电极组件300产生超声波进行治疗。
其中,电极组件300包括外电极部件301、内电极部件302和绝缘部件303,内电极部件302和外电极部件301由铂铱合金等导电金属材料制成,绝缘部件303则由绝缘材料制成,电极组件300整体成层状包覆结构,外电极部件301和内电极部件302分别处于外层和内层,绝缘部件303处于中间层,通过绝缘将内电极部件302和外电极部件301分开,避免二者直接接触,具体的,绝缘部件303为一绝缘管,其内表面和内电极部件302的外表面相贴合,其外表面和外电极部件301的内表面相贴合,外电极部件301整体成套筒状,即外电极部件301套接在绝缘部件303上,内电极部件302为一片状弧形板,其紧贴在绝缘部件303的内圆周表面。
进一步的,该电极组件300沿外电极部件301的直径方向开设有圆孔部件304,该圆孔部件304从外电极部件301的外表面一直延伸至内电极部件302的外表面,即该圆孔部件304贯穿外电极部件301和绝缘部件303的侧壁,更具体的,该圆孔部件304包括和外电极部件301壁厚大致相同的第一区段304a以及和绝缘部件303壁厚大致相同的第二区段304b第一区段304a和第二区段304b的截面直径可以不同,同时由于该圆孔部件304一直延伸至内电极部件302的外表面,即通过内电极部件302对圆孔部件304的内侧端(即靠近导管部件100截面圆心的一端)进行封闭,通孔部件的外侧端和填充区间201相连通,此时内电极部件302和通孔部件共同形成一端开口的电场区间305,通过在内电极部件302和外电极部件301上施加高压脉冲,以电场区间305内的空气作为放电介质,从而形成脉冲声波,从而对钙化病变区域进行治疗。
进一步的,电极组件300还包括薄膜部件400,对应的,外电极部件301表面在圆孔部件304外侧端的四周设有粘接区域401,通过将薄膜部件400的边缘通过粘接等方式固定在粘接区域401,薄膜部件400的主体部分对通孔部件的外侧端的形成覆盖,从而在通孔部件的外侧端形成一保护层,即通过薄膜部件400将通孔部件的外侧端进行封闭,此时通孔部件的侧壁、内电极部件302的外表面同薄膜部件400共同围成一近似封闭的电场区间305,位于填充区间201内的液体无法穿过薄膜部件400进入电场区间305内造成短路,保证放电过程的安全性和稳定性。
现给出该薄膜部件400的具体实施例:
实施例一:该薄膜部件400由玻璃纤维结合纳米材料制成,由玻璃纤维结合纳米材料制成的薄膜部件400具有透明、耐热和高韧性等特点,通过在通孔部件的外侧端设置薄膜部件400,填充区间201内的填充液无法穿过该薄膜部件400进入电场区间305内,且该薄膜部件400具有和填充区间201内填充液(如造影液)相同的声波传递能力,即该薄膜部件400一方面起到了隔绝填充液而形成近似封闭的电场区间305的作用,另一方面,该薄膜部件400起到声波传递的作用,能够作为声波的传递介质,当球囊导管处于治疗态,即填充区间201内充满填充液后,和内电极部件302以及外电极部件301连接的脉冲发生器放出脉冲,内电极部件302和外电极部件301之间产生的电流击穿空气,从而形成一个短暂爆发的声压波,该声波经过薄膜部件400以及填充液的传播后穿过球囊部件200到达血管壁上的治疗区域进行治疗,同时考虑到内电极部件302和外电极部件301在放电过程中产生的高温,该薄膜部件400具有耐高温的能力,不会在高温环境下融化。
实施例二:该薄膜部件400由明胶等胶质物制成,和实施例一种薄膜特性相类似,本实施例中的薄膜部件400同样具有耐高温以及作为声波传递介质的特性,和实施例一不同的是,该薄膜部件400具有脱水态和含水态两种状态,两张状态和球囊导管的输送态和治疗态相对应,当球囊部件200处于输送态时,薄膜部件400处于脱水态,即将明胶等胶质物脱水后通过粘接等方式固定在外电极部件301上的粘接区域401,当球囊部件200运动至血管上的病变位置后,通过向填充区间201内注入填充液使其扩张,即使球囊导管处于治疗态后,由胶质物制成的薄膜部件400遇水之后恢复粘性,从而在圆孔部件304的外侧端形成一层保护膜,阻止填充区间201的内的液体进入电场区间305。
实施例三:本实施例中的薄膜部件400由承载了过氧化钠或干冰等物质的薄膜构成,和实施例一和实施例二中的薄膜部件400同样具有耐高温以及作为声波传递介质的特性,在内电极部件302和外电极部件301放电时,不会因为高温而融化,同时能够作为声波的传递介质,和实施例一和二不同的是,该薄膜部件400具有一般态和作用态两种形态,两种形态和球囊导管的输送态以及治疗态相对应,当球囊导管处于输送态时,薄膜部件400处于一般态,球囊导管处于治疗态时,薄膜部件400处于作用态,具体的,当球囊部件200到达血管上的病变位置时,通过向填充区间201内注入填充液使球囊部件200扩张,此时薄膜部件400内的过氧化钠等物质遇水之后会释放出气体从而将处于圆孔部件304外侧端的液体驱离圆孔部件304的外侧端,即阻止填充区间201内的液体进入电场区间305内造成短路。
尽管已经示出和描述了本发明的实施例,对于本领域的普通技术人员而言,可以理解在不脱离本发明的原理和精神的情况下可以对这些实施例进行多种变化、修改、替换和变型,本发明的范围由所附权利要求及其等同物限定。
Claims (9)
1.一种封闭电极脉冲球囊扩张导管,其特征在于:包括
导管部件以及设置在所述导管部件远端的球囊部件,所述导管部件和所述球囊部件形成有填充区间;
电极组件,所述电极组件包括外电极部件、内电极部件、绝缘部件和圆孔部件,外电极部件和内电极部件分别处于外层和内层,绝缘部件处于中间层,所述内电极部件同所述圆孔部件共同形成一外端开口的电场区间,圆孔部件从外电极部件的外表面一直延伸至内电极部件的外表面,圆孔部件贯穿外电极部件和绝缘部件的侧壁,内电极部件对圆孔部件的内侧端进行封闭;
薄膜部件,包覆在所述圆孔部件的外侧端,薄膜部件的边缘通过粘接固定在所述外电极部件上的粘接区域,当球囊导管处于治疗态时,所述薄膜部件对所述圆孔部件的外侧端进行封堵,阻止所述填充区间内的液体进入所述电场区间,并以所述薄膜部件作为声波的传递介质实现治疗。
2.根据权利要求1所述的一种封闭电极脉冲球囊扩张导管,其特征在于:所述薄膜部件由玻璃纤维结合纳米材料制成。
3.根据权利要求2所述的一种封闭电极脉冲球囊扩张导管,其特征在于:所述薄膜部件由胶质物制成。
4.根据权利要求3所述的一种封闭电极脉冲球囊扩张导管,其特征在于:所述胶质物以脱水态进行输送,当所述球囊导管处于治疗态时变成含水态从而在所述圆孔部件的外侧端形成保护膜。
5.根据权利要求3所述的一种封闭电极脉冲球囊扩张导管,其特征在于:所述胶质物是明胶。
6.根据权利要求1所述的一种封闭电极脉冲球囊扩张导管,其特征在于:所述薄膜部件由承载了过氧化钠或干冰的薄膜构成。
7.根据权利要求6所述的一种封闭电极脉冲球囊扩张导管,其特征在于:所述薄膜部件以一般态进行输送,当所述球囊部件处于治疗态时遇水释放气体阻止液体进入所述电场区间。
8.根据权利要求1所述的一种封闭电极脉冲球囊扩张导管,其特征在于:所述外电极部件和内电极部件的材料包括铂铱合金。
9.根据权利要求1所述的一种封闭电极脉冲球囊扩张导管,其特征在于:所述球囊部件的材料包括尼龙。
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