CN110124133B - 一种难治性心力衰竭左心室功能辅助装置 - Google Patents
一种难治性心力衰竭左心室功能辅助装置 Download PDFInfo
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Abstract
本发明公开了一种难治性心力衰竭左心室功能辅助装置,吸头内部设计多条吸管与囊腔隧道,外部吸孔开口于吸头的下壁及外侧,向内通向近心端锥形囊腔,其管道内与囊腔相通处设计单向阀,经单向阀与气囊内腔相通,吸管跨瓣膜内为单通道与水滴形吸头相连接,远心端与气囊室相通,梯形侧面外壁设有单向阀,单向阀通过通道与气囊室内腔相通;囊体外侧设有4个单向阀,上端为圆锥形通过气管与气腔隧道相连接;分支气管向下经过气囊室开孔于气囊壁内侧,向上汇合成主气管,经动脉与体外相通,导丝下端与水滴型吸头相通。本发明的有益效果是在左心室功能丧失的情况下,亦可连续工作,为临床抢救,或者心脏移植争取时间。
Description
技术领域
本发明属于医疗器械技术领域,涉及一种难治性心力衰竭左心室功能辅助装置。
背景技术
急性心力衰竭:主要表现为左心功能下降,即左心室泵血功能降低,心脏泵功能不全,做功减少,左心室淤血,从而导致患者出现肺部淤血,呼吸困难。该装置可以辅助左心室做功,使肺部淤血减轻,从而减少左心室做功,使左心室泵功能恢复,减轻急性左心功能不全导致肺部淤血,肺水肿,缓解患者呼吸困难,喘憋等症状,帮助患者顺利度过急性心肌梗死,急性左心功能不全以及其他原因导致的高度危险期,顺利实现康复。目前世界各国已经在临床开始应用的心衰辅助装置主要有:1、TandemHear装置,TandemHeart经由皮肤跨隔膜心室辅助(PTVA),PTVA系统是一种左心室辅助设备LVAD,设计作为短期循环支持系统,不需要彻底的心肺通路手术。该系统由三个部分组成:TandemHeart泵,提供循环动力将氧合血液从左心房中抽吸出来,推进至全身动脉循环系统;TandemHeart套管组件,将泵通过2条经皮肤通路腹股沟穿刺点连接起来;TandemHeart控制器,为泵提供动力,为泵提供润滑剂。2、Impella系统,为一种恒速运转系统,需要切开动脉植入,虽然操作便捷,可用于左或右心室辅助循环;但同样需要左心室功能有保留,因此患者耐受性较差,且该装置无法模拟人体血流节奏型搏动,故会导致主动脉等血管持续扩张,引起患者血压升高致头痛等不适。3、Systems pLVAD,泵在体外,需要开胸植入,将泵管经皮肤与装置链接,可根据需要更换不同功率和心排量的泵,而不需重新置换导管系统;但明显增加患者耐受手术风险,增加感染几率。4、体外膜氧合器Extracorporeal membrane oxygenation,ECMO即体外“膜肺”,将静脉系统血液送至体外膜氧合器充分氧合后再输送至动脉系统,又称为全心肺支持Fullcardiopulmonary support。特点是氧合作用很好,但不能真正直接做到心脏“无负荷”工作,且因在外周血管建立了静脉-ECMO-动脉通路而增加了心脏后负荷。适合于伴有严重低氧血症的ACS。5、主动脉球囊反搏”装置(IBAP),经股动脉微创植入降主动脉,心电门控控制充放气,通过气囊充放气实现与心脏同步跳动,模拟心脏泵功能,辅助血液流动,实现向全身各脏器供血功能。
上述装置各有优缺点,缺点主要在于完全替代左心室,或者均要求左心室收缩泵功能保留,即要么完全置换左心室,不能实现生理学泵血,要么要求左心室功能保留且只能极小部分辅助左心室进行工作,而无法较大程度代替左心室的功能,而大部分急性左心功能衰竭,尤其冠脉前降支急性闭塞导致的急性心肌梗塞均为左心室泵功能丧失,故其临床应用适应症较为局限,效果较差。而且以上1,2装置需要开胸行心脏置换,或心脏部分置换,创伤大,效果差,尤其远期效果差,并发症多。大部分目前临床使用的左心室辅助装置均为非心电门控类型,不能与心室收缩同步,故不能很好地模拟人体血流动力学,对脏器的血流灌注效果较差。本实用新型装置应用于早期,是针对突发,阶段性心功能不全而应用的临时心功能辅助技术,也针对晚期心功能丧失,行异体心脏置换,或人工心脏置换过渡时期替代左室辅助装置。
发明内容
本发明的目的在于提供一种难治性心力衰竭左心室功能辅助装置,本发明的有益效果是装置工作不需要依赖左心室功能保留,即在左心室功能丧失的情况下,亦可连续工作,为临床抢救,或者心脏移植争取时间,可以有效的降低因左心功能下降,泵功能衰竭导致的死亡率。
本发明所采用的技术方案是包括螺旋形吸管和水滴型吸头,吸头内部设计多条吸管与囊腔隧道,外部吸孔开口于吸头的下壁及外侧,向内通向近心端锥形囊腔,其管道内与囊腔相通处设计单向阀,经单向阀与气囊内腔相通,吸管跨瓣膜内为单通道与水滴形吸头相连接,远心端与气囊室相通,梯形侧面外壁设有单向阀,阀门向外开放,单向阀通过通道与气囊室内腔相通;囊体为圆筒形结构,由形状记忆合金构成,体外为收缩状态,到达体内后释放即形成圆柱体,下端与心室相通,外侧设有4个单向阀,阀门向外开放,上端为圆锥形通过气管与气腔隧道相连接;分支气管向下经过气囊室开孔于气囊壁内侧,向上汇合成主气管,经动脉与体外相通,导丝下端与水滴型吸头相通。
进一步,吸管跨瓣膜段长度30-50cm,扁叶型。
进一步,囊体为360度附壁设计,排气阶段,气囊回缩,囊腔空间增大,呈负压,血液自吸头经螺旋形吸管吸入囊腔,充气时呈向心性膨胀,将血液同时向主动脉窦底近心端及主动脉弓两个方向排送,保证冠状动脉及锁骨下动脉,颈动脉及外周动脉供血。
进一步,气囊闭锁点为下部靠上1/3位置。
进一步,心电门控气泵需要进行心电门控,靠心电图上升支R波触发,即R波上升期心室收缩早期开始排气-也就是抽吸,T波开始时心室舒张早期,此时主动脉瓣关闭开始充气,此时主动脉瓣关闭-排血至主动脉内,此装置为氮气驱动装置,氮气为外部持续冷却后进行充放气工作。
附图说明
图1是本发明装置结构示意图。
图中,1、导丝;2、水滴形吸头;3、吸孔;4、螺旋形吸管;5、单向阀;6、近心端锥形囊腔;7、气囊室;8、囊体;9、分支气管;10、气管升段;11、气管弓段;12气管降段;13、心电门控气泵;14、心电导联线;15、吸管与囊腔隧道;16、气管与气腔隧道;17、吸管跨瓣膜段;18、囊腔。
具体实施方式
下面结合具体实施方式对本发明进行详细说明。
本发明装置如图1所示,室内段:分为螺旋形吸管4和水滴型吸头2两部分,吸头内部设计多条吸管与囊腔隧道15,外部吸孔3开口于吸头的下壁及外侧,向内通向近心端锥形囊腔6,其管道内与囊腔18相通处设计单向阀,经单向阀5与气囊内腔相通,血液被吸入后,保证在气囊充气阶段,血液不返流,并经囊腔单向阀5将排到主动脉内。吸管跨瓣膜段17长度30-50cm,扁叶型设计,内为单通道与水滴形吸头2相连接,远心端与气囊室7相通,梯形侧面外壁设计单向阀5,数量4个,阀门向外开放,保证冠脉供血的同时,避免射血损伤冠脉开口,单向阀5通过通道与气囊室7内腔相通。囊体8为360度附壁设计,排气阶段,气囊回缩,囊腔18空间增大,呈负压,血液自吸头经螺旋形吸管吸入囊腔18,充气时呈向心性膨胀,将血液同时向主动脉窦底近心端及主动脉弓两个方向排送,保证冠状动脉及锁骨下动脉,颈动脉及外周动脉供血。
气囊闭锁点为下部靠上1/3位置,优先下部充气,保证下壁气囊先膨胀,以保证三分之一的血液灌注冠脉,三分之二的血液向主动脉方向分流,防止较多血液灌注冠状动脉,损伤其冠脉开口。
囊体8,此部分为圆筒形结构,由形状记忆合金构成,体外为收缩状态,到达体内后释放即形成圆柱体,下端与心室相通,在其外侧设计4个单向阀5,阀门向外开放,上端为圆锥形通过气管与气腔隧道16相连接。
分支气管9为2-4根,向下经过气囊室开孔于气囊壁内侧,向上汇合成主气管,经股动脉与体外相通。导丝1下端与水滴型吸头相通,先将导丝1送至左心室,沿交换轨道导入水滴吸头2,经体外段气管与体外相通,便于交换。气管升段10、气管弓段11、气管降段12与体外相接。心电门控气泵13需要进行心电门控,靠心电图上升支R波触发,即R波上升期心室收缩早期开始排气-也就是抽吸,T波开始时心室舒张早期,此时主动脉瓣关闭开始充气,此时主动脉瓣关闭-排血至主动脉内,此装置为氮气驱动装置,氮气为外部持续冷却后进行充放气工作。本装置亦可同时在急性心梗时辅助冠脉介入治疗。
本发明装置外接气泵驱动,心电门控,通过心电导联线14与患者链接,通过气管外管连接体内气囊,通过气囊充气,放气,模拟并同步左心室收缩过程,辅助左心室搏血,减轻左心室前负荷。
本发明装置工作过程:1气囊于心室舒张末期放气,此时气囊回缩,囊腔空间扩大,并呈负压状态,从左心室抽血15-20ml,从而减少左心室血容量,降低左室收缩前负荷,降低左心室做功,降低心肌耗氧量,改善心功能。2于收缩末期即舒张极早期开始充气,此时气囊膨胀,囊腔空间被压缩,并呈正压状态,从左心室抽血15-20ml,分别经本装置的近心端及远心端排血孔,排出血液至主动脉,此时可以主动辅助主动脉瓣膜关闭,从而改善冠脉及外周供血。
本发明装置优点还在于可缓解晚期左心功能不全,延长患者寿命,改善急性心梗导致急性左心衰患者预后,PCI术中无复流,TIMI血流0-1级。可代替目前临床使用的IBAP。
以上所述仅是对本发明的较佳实施方式而已,并非对本发明作任何形式上的限制,凡是依据本发明的技术实质对以上实施方式所做的任何简单修改,等同变化与修饰,均属于本发明技术方案的范围内。
Claims (1)
1.一种难治性心力衰竭左心室功能辅助装置,其特征在于:包括螺旋形吸管和水滴型吸头,吸头内部设计多条吸管与囊腔隧道,外部吸孔开口于吸头的下壁及外侧,向内通向近心端锥形囊腔,其管道内与囊腔相通处设计单向阀,经单向阀与气囊内腔相通,吸管跨瓣膜内为单通道与水滴形吸头相连接,远心端与气囊室相通,梯形侧面外壁设有单向阀,阀门向外开放,单向阀通过通道与气囊室内腔相通;囊体为圆筒形结构,由形状记忆合金构成,体外为收缩状态,到达体内后释放即形成圆柱体,下端与心室相通,外侧设有4个单向阀,阀门向外开放,上端为圆锥形通过气管与气腔隧道相连接;分支气管向下经过气囊室开孔于气囊壁内侧,向上汇合成主气管,经动脉与体外相通,导丝下端与水滴型吸头相通;
所述吸管跨瓣膜段长度30-50cm,扁叶型;
所述囊体为360度附壁设计,排气阶段,气囊回缩,囊腔空间增大,呈负压,血液自吸头经螺旋形吸管吸入囊腔,充气时呈向心性膨胀,将血液同时向主动脉窦底近心端及主动脉弓两个方向排送,保证冠状动脉及锁骨下动脉,颈动脉及外周动脉供血;
所述气囊闭锁点为下部靠上1/3位置;
心电门控气泵需要进行心电门控,靠心电图上升支R波触发,即R波上升期心室收缩早期开始排气-也就是抽吸,T波开始时心室舒张早期,此时主动脉瓣关闭开始充气,此时主动脉瓣关闭-排血至主动脉内,此装置为氮气驱动装置,氮气为外部持续冷却后进行充放气工作。
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