CN1142351A - 房间隔缺损闭合器 - Google Patents
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本发明是一种房间隔缺损闭合器。用于治疗先心病房间隔缺损畸形。它具有外包膜1,1中置有压缩的闭合器主体2和3及顶棒4和5,主体3为二根密圈的细弹簧,主体2为两根不锈钢丝架,其中一根中间带有圆环10。主体2与3中央段相互粘或焊牢而外段游离。两细线6穿行3与5中,另一细线穿过10与4使两主体与两顶棒相连。主体2上被覆布织品7,7中央缝以圆形薄层海绵8。本发明可避免开胸手术之苦,安全可靠,价廉简便,容易推广采用。
Description
本发明涉及医疗器械,具体是一种房间隔缺损闭合器。
房间隔缺损(ASD)是一种最常见的先天性心脏病,发病率居先心病之首位,以往均靠开胸手术治疗。1974年国外发明了一种非开胸手术治疗本病的介入治疗方法,其采用一种房间隔缺损封堵器经心导管术来封闭房间隔缺损,为非手术治疗先心病开辟了又一新路,该技术在国内尚处起步阶段,其原因在于国外现有的房间隔缺损介入治疗技术也还不够完善,且进口的房间隔缺损封堵装置十分昂贵,而国内在此领域迄今还无自己设计的装置。到目前为止,国外主要有以下几种房间隔缺损的封堵装置,双盘补片式,单盘带钩式,双伞式,自动定心式及双盘扣合式等闭合器,但均不太理想,这些方法主要存在的缺点是:1、操作复杂,有的需多个步骤完成;2、运送装置粗大,不适合较幼小儿童,且血管损伤大;3、不易定中心,闭合器常偏向一侧而造成闭合不严;4、对较大的房间隔缺损闭合效果较差;5、闭合器送入左房后,不易定位,稳定性亦差,且不易取出;6、价格昂贵,每套闭合器及配套装置进口价达5万元人民币。
近年来,国外有些学者对上述问题作了些改进,但仍不甚尽人意,临床应用仍有很大限度。
尽管外科手术治疗房间隔缺损已相当安全,但介入治疗毕竟是一种不用开胸的方法,应大力研究,以取代手术治疗。目前要解决的主要问题是:1、简化操作,最好能一次到位;2、能自动定中心,到位后不会移动;3、大、小房间隔缺损均适宜,且闭合充分;4、运送系统要细小;5、安全可靠,送取方便;6、价格便宜。
本发明的目的是针对目前介入法治疗房间隔缺损的上述问题,提供一种操作简便,价格低廉,运送系统较细小,适合各年龄患者,不受缺损大小的限制,能自动定中心,定位稳定牢靠,使用安全,且能撤换的房间隔闭合器。
本发明是这样实现的:房间隔缺损闭合器包括外包膜、闭合器主体、顶棒及细线或和带钩钢丝。闭合器主体主要是由二根十字交叉的不锈钢丝架及粘或焊有与之平行的密圈细弹簧构成,不锈钢丝的两端发分别有一园孔,其中一根不锈钢丝中间还带有园环,钢丝架上缝有弹性好的涤沦布或其他布织品,密圈细弹簧中央段与钢丝架焊牢或粘贴紧,两侧为游离状,细弹簧内可穿过细线。闭合器主体的密圈细弹簧内分别引进两条细线并反折成双穿过粗顶棒内,钢丝架中央的园环可引进细线并反折穿过细顶棒,也可从细顶棒内送入一钢丝挂钩与园环相扣。前者细顶棒与园环脱离是通过切断一侧细线并将之拉出实现;后者园环与带钩不锈钢丝的扣合是将其挂钩置于园环内再把细筒将两者套住而成,若将细筒后撤则挂钩与园环无法固定而自动脱开。
闭合器主体可以压缩与顶棒一起装于外包膜内。
闭合器主体的不锈钢丝架可以是直式的,也可以是折曲式两种类型,直式是指钢丝架为直的十字架结构,折曲式是指钢丝架的中央折曲呈凹形的交叉结构,中央折曲的距离依房间隔缺损大小而定。密圈细弹簧可以是整条均为细弹簧式,也可以中央拉直为细丝而外侧为密圈细弹簧;密圈细弹簧折曲与否与不锈钢丝架相反,前者直式则后者折曲,反之亦然。
闭合器主体被覆的布织品,可以是单层,也可以在折曲式钢丝架的凹陷部加缝一层园形涤纶布或泡沫海棉等。
推进闭合器用的顶棒由两个同心的园筒构成,一粗一细,粗筒内接收穿行于密圈细弹簧内的两对细线与主体相连;细筒与主体相连则有两种方式,一是通过接收穿过园环的一对细线与主体相连,另一是通过带挂钩的可脱性细钢丝与主体之园环扣合相接;粗细双筒间可以活动;粗园筒的顶端有四个对称的侧孔。
使用时,与心导管及长静脉鞘管配合,先将长鞘管经股静脉——下腔静脉——右房——房间隔缺损送至左房内,然后把闭合器沿鞘管送到左房,鞘管撤回右房,再用顶棒将闭合器主体推出外包膜,使之展开,先拉紧细筒内的细线或带挂钩的可脱性不锈钢丝,使细筒顶住主体钢丝架,粗筒稍向后撤,再拉紧密圈细弹簧内的细线,使外段未焊接或粘贴的游离状密圈细弹簧,弯曲呈倒锥形。固定好各细线,然后慢慢回拉整个闭合器,因密圈细弹簧已呈倒锥形,故回拉时其能自动定中心,使十字交叉的钢丝架均匀对称地紧贴于房间隔缺损的左房侧壁上,而弯成倒锥形的密圈细弹簧则自动定中心并越过房间隔缺损,进到右房侧。此时,固定细筒,将粗筒内的两对穿过密圈细弹簧的细线松开,则密圈细弹簧回弹到原位与对侧的钢丝架一道分别卡在房间隔缺损的两侧,因钢丝架上缝有布织品或薄层海棉,从而把房间隔缺损封闭。检查闭合器到位及稳定情况满意后,先分别拉出粗筒内即穿过密圈细弹簧内的细线,最后才抽出细筒内的细线或使可脱性不锈钢丝与主体之园环脱钩,使闭合器主体与顶棒分离,撤出鞘管及顶棒,主体留于体内封闭房间隔缺损,房间隔缺损介入治疗闭合术完毕。在顶棒与主体脱离之前,若定位不满意还可反复调整,若闭合器主体与缺损大小不相配,则可将闭合器主体拉入鞘管内,再行撤换或其他处理。
本发明可避免开胸手术带来的痛苦,在门诊便可进行,克服了现有其他一些介入治疗方法存在的不足,安全可靠成本低,容易推广采用。
图1是本发明的结构图;图2是闭合器主体(直式)展开后正面结构经细线与顶棒联系图;图3是闭合器主体(折曲式)展开后斜面结构经细线和带钩不锈钢丝与顶棒联系图;图4是闭合器主体(直式)与细筒内可脱性不锈钢丝联系侧面图;图5是闭合器主体(直式)经细线与顶棒联系侧面图;图6是闭合器主体(折曲式)密圈细弹簧拉紧后与顶棒联系侧面图;图7是经长鞘管运送闭合器至左房示意图;图8是闭合器于左房展开后回拉并自动定中心示意图;图9是密圈细弹簧越过房间隔缺损后示意图;图10是闭合器主体完全封闭房间隔缺损示意图。图7至图10是表示本闭合器与长静脉鞘管配合封闭房间隔缺损的操作过程图。
上述图中的代号分别代表:1为外包膜,2是闭合器主体之一的不锈钢钢丝架,3是另一闭合器主体密圈细弹簧;4是细顶棒,5是粗顶棒,6是细线,7是布织品,8是海棉或布织品,9是可脱性细不锈钢丝,10是主体2中间的园环,11是可脱性不锈钢丝9顶端的挂钩,12是主体2两端的园孔,13是粗顶棒顶端四个对称的侧孔,14是房间隔缺损的壁,15是长静脉鞘管。
下面结合附图对本发明作进一步说明:房间隔缺损闭合器包括外包膜1,闭合器主体2和3,顶棒4和5,及细线6或和可脱性不锈钢丝9。闭合器主体2被覆有涤沦布等布织品7,布织品7的中央可以加厚成双层或加缝以薄层海棉8。细线6将闭合器主体2、3分别与顶棒4、5连接,压缩后的闭合器主体及顶棒一起装在外包膜1中。
闭合器主体结构之一的2为二根十字交叉样不锈钢丝架,两根不锈钢丝的两端分别有一园孔12,园孔具有防止刺伤心内结构及便于布织品缝牢固定作用,其中一根中间还带有园环10,不锈钢丝架可是直式(图2、4、5)或折曲式(图3、6、8、9、10);闭合器主体3为两条绕成密圈的细弹簧,其可整根均为密圈细弹簧(图5),也可中央段为直钢丝而外侧段则绕成密圈细弹簧(图2、3、4、6、8、9、10),与直式不锈钢丝架相配的密圈细弹簧的外侧段可稍呈折曲式(图4,5)。顶棒4为一细直筒,由金属或塑料等制成,顶棒5为一较粗的园筒,由塑料或高分子材料制成,其顶端有四个对称的侧孔13(图5、6),穿行于密圈细弹簧内的两对细线便穿过这四个对称的侧孔13进入粗顶棒5内。
细线6可以是抗拉性的尼龙线,顶棒4细直筒内的细线亦可用可脱性带挂钩的不锈钢丝9代替。应用时,不锈钢丝9的挂钩11置于闭合器主体之一2的园环10内,顶棒4细直筒把园环10及挂钩11套住并固定(图3、6),欲脱钩时,把顶棒4松开后撤离园环10,则挂钩11与园环10自动脱离(图4)。顶棒4和5与闭合器主体2和3分离后,闭合器主体2和3以及其附件7或和8留于体内封闭房间隔缺损,其余部分均撤出入体。
其具体操作如下:穿刺右股静脉,按常规操作把长静脉鞘管15经下腔静脉、右房送过房间隔缺损14进入至左房,再经鞘管15把房间隔闭合器送入左房(图7),撤离鞘管15至右房,并把闭合器顶出外包膜1,使闭合器主体2、3充分展开。先拉紧细筒内之细线,使顶棒4紧靠于主体2的园环10上或拉紧可脱性不锈钢丝9并固定,再拉紧粗筒5内的细线,使主体3密圈细弹簧对称地弯曲成倒锥形,固定好粗、细顶棒4、5及细线6,慢慢后撤整个闭合器(图8);闭合器借助主体3的倒锥形结构,自动定中心并越过房间隔缺损14,使主体2的游离段均匀地贴紧房间隔缺损的左房侧壁(图9),这时仍固定细顶棒4,先松开粗顶棒5里的细线,则主体3细弹簧钢圈靠其自身弹性自动复位,贴于房间隔缺损的右房侧壁上,并和主体2一起将房间隔缺损闭合器卡住房间隔缺损,因主体2上缝有布织品7或和薄层海棉8,故房间隔缺损被完全闭合(图10);在确定闭合器位置固定牢靠后,先撤出粗顶棒5中的两对细线,万无一失后再撤去细顶棒4中的细线或可脱性带挂钩之不锈钢丝。这样,闭合器便与输送装置顶棒4和5、外包膜1及静脉鞘管15完全脱离,前者留于体内将房间隔缺损封闭,后者则全部撤出体外,房间隔缺损介入性封闭术完毕。
若在闭合器主体与细顶棒4脱离之前,发现房间隔缺损闭合器闭合不严,固定不牢可以移动,或闭合器与房间隔缺损大小不相配匹时,还可将闭合器拉入静脉鞘管15内撤出,再根据情况决定是撤换另一型号的闭合器还是改为手术治疗。即使由于房间隔缺损情况特殊而介入性治疗失败,也完全不影响开胸手术治疗效果。
Claims (8)
1、一种房间隔缺损闭合器,包括外包膜,闭合器主体,顶棒和细线或和带钩细钢丝,其特点在于闭合器主体之一是十字交叉的二根不锈钢丝架,钢丝架两端分别有一园孔,其中一根不锈钢丝架中间还带有园环;二根不锈钢丝架上粘或焊有另一闭合器主体即二根密圈细弹簧,粘或焊接部位于不锈钢丝架及密圈细弹簧的中央段,其外段呈游离状;钢丝架上还被覆缝有涤沦布或其他布织品,涤沦布的中央还可缝有园形的相同或不同布织品或薄层海棉等;密圈细弹簧内能让细线通过;闭合器主体通过穿行于不锈钢丝架上的园环及密圈细弹簧内的对折细线或和带挂钩的不锈钢丝与顶棒相连;闭合器主体可以压缩并与顶棒一起装入外包膜内。
2、按权利要求1所述的房间隔缺损闭合器,其特征在于闭合器的主体不锈钢丝架为直式,而密圈细弹簧为折曲式。
3、按权利要求1所述的房间隔缺损闭合器,其特征在于闭合器主体的不锈钢丝架为折曲式,而密圈细弹簧为直式。
4、按权利要求1所述的房间隔缺损闭合器,其特征在于闭合器主体的密圈细弹簧为一完整连贯的细弹簧。
5、按权利要求1所述的房间隔缺损闭合器,其特征在于闭合器主体的密圈细弹簧的中央段为未绕成弹簧结构而是拉直为一条直不锈钢丝。
6、按权利要求1所述的房间隔缺损闭合器,其特征在于闭合器主体均由细线与粗、细两个顶棒相连。
7、按权利要求1所述的房间隔缺损闭合器,其特征在于闭合器主体的密圈细弹簧通过细线与粗顶棒相连,而闭合器主体不锈钢丝架中央的园环与细顶棒间通过可脱性带挂钩的不锈钢丝相连。
8、按权利要求1所述的房间隔缺损闭合器,其特征在于顶棒分粗、细二根,为同心园筒可互相活动;粗园筒顶端有四个对称的侧孔。
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