CN1211132C - 可移植的心脏辅助系统 - Google Patents
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Abstract
一种用来补充患者血液循环的心脏外泵送系统(10),其任何元件都不与心脏连接,以及使用该系统的方法。该心脏外系统包括一个以最小侵入方法在腹股沟处或附近皮下移植的泵(32),其中泵被电池(44)驱动,为电池充电的设备是离体的,其中泵通过用皮下交叉合流连接液体连接到患者股动脉(26)流入导管(50)抽取血液,并通过用皮下交叉合流连接液体连接到源自患者的动脉弓的外围动脉流出导管(52)流出血液,可以连续或脉动方式进行操作,与患者的心脏同步,从而有可能降低对心脏的泵送负荷。
Description
本发明概括涉及一种用来帮助心脏的系统,特别是一种心脏外泵系统和对患者使用一个最小侵入方法补充血液循环的方法。
在最近的十年,充血性心力衰竭(CHF)已经成为心血管医学领域最重要的公共健康问题。正如在美国心脏杂志(Heart J.)126,1042(1993)中的Gilum,R.F.,心力衰竭流行病学(Epidemiology of Heart Failure)报告的那样,每年在美国诊断出四十万(400,000)CHF的新病例。据说该疾病在美国几乎影响5百万人,在全世界接近于二千万人。在过去的十五年中因CHF而住院的人数已经增长了三倍多。不幸的是,每年有近250,000患者死于心力衰竭。根据Framingham心脏研究报告,患有充血性心力衰竭的男性的5年死亡率是75%,女性是62%(Ho,K.K.L,Anderson,K.M.,Kannel,W.B.,等人.,Framingham心脏研究报告患者在充血性心力衰竭发作后的存活率(Survive After the Onset ofCongestive Heart Failure in Framingham Heart Study Subject),88循环(Circulation)107(1993))。这种疾病代表了65岁以上的患者最常见的诊断结果。尽管在过去10到20年间大多数的心血管疾病的发生率已经降低,但是充血性心力衰竭的发病率却以惊人的速率增长。这一数字将随着现存的通常将死于急性心肌梗塞(心力衰竭)的患者以及人口年龄的增长而增长。
CHF自身主要表现为运动性呼吸困难(呼吸困难或吃力)和疲劳。三种模式被用来描述CHF的原因和治疗。第一种是根据泵压功能和异常循环动力学的改变察看病情。其它模型主要基于改变的心肌细胞性能的改变或在衰退心脏中细胞基因表达的改变来描述的。以其最广义的理解,CHF可以被定义为心脏不能以所需的速度向身体泵送血液以维持足够血流和许多身体的正常功能。
为了治疗CHF,已经开展了多种的心脏辅助设备。心脏或循环辅助设备是通过增加心脏泵送功能或使得心脏有一定程度的休息来恢复心脏泵送功能而辅助损伤的心脏的。因为充血性心力衰竭可以是慢性的或急性的,存在不同种类的心脏辅助设备。除心脏移植以外,至少开发了两种慢性的心脏辅助系统。一种是使用连接心脏和主动脉的全部或部分的假体,其一个例子通常是指一种LVAD-左心室的辅助设备。此处参照图1,示出了LVAD2的一个例子。该LVAD包括一个泵和相关的阀门4,把血液直接从左心室6的顶部抽出,并引导血液到主动脉弓8。在这种应用中,左心室停止作用,并且既不收缩也不舒张。左左心室实际上成为左心房的延伸,LVAD2代替了左心室,绕过主动脉瓣。因此,该心室就成为一个低压的室。因为目的是为了接替左心室,以心脏的速率泵送血液操作LVAD。利用LVAD,就建立足以满足患者要求的充氧的血液的循环。
另一种慢性心脏辅助系统在Moulder的U.S.专利No.5,267,940示出。Moulder描述一个移植到主动脉降基部的泵,以帮助通过主动脉的血液循环。
在治疗急性CHF中已经使用了两种心脏辅助设备,一种实际上是反搏的,例如通过一种主动脉内气球泵(IABP)来进行。利用IABP,该气球在等容收缩的时候被压扁,提供一个对心脏的压力降,使心脏必须泵送血液,从而减少在心脏收缩时的负荷。然后气球膨胀,迫使血液全方向的通过动脉系统。第一种急性心脏辅助设备的另一例子使用一个或多个可压缩的室,其中在心脏收缩的时候血液被动地流入室中,如Robinson等人的美国专利No.4,240,409所示。然后室被压扁并且把血液被强制性送回主动脉。该设备模拟心的一个室并依靠一个可膨胀的气囊完成泵送作用,需要一个外部的空气的驱动器。
第二种辅助设备利用一台体外泵,例如Biomedicus离心泵,以引导血液通过患者,同时在心脏进行外科手术。在Nelson的美国专利No.4,968,293描述的例子中,该心脏辅助系统使用一个安装在患者肌肉中的离心泵以向血流增加脉动性。Nelson设备被用来绕过部分主动脉降。
在Bregman等人的美国专利No.4,080,958中显示了另一设备,利用一种可膨胀和可压扁的气囊在心脏损伤的时候辅助血液灌流,并且通过给予脉动刺激旨在补充传统心-肺机的不足。在Bregman公开的主要实施方案中,控制该气球,在心脏舒张期使主动脉根保持足够的压力以确保有足够的血液充满冠状动脉。在一个可选的实施方案中,从主动脉到下级大静脉提供了一个低阻出口以降低在心脏收缩的时候主动脉的压力,从而,减少在左心室的血液动力学负荷。
其他设备,例如在Thoma的美国专利No.4,034,742所示的设备,取决于与含可动泵送膜片的机械泵送室的交互作用和协调。这些设备主要应用在心脏附近并且在患者胸腔内部,需要大的侵入性外科手术。
许多CHF设备是在手术期紧急使用。例如安纳德的美国专利No.4,995,857公开了一种手术设备,当心脏已经衰退或已经停止时在外科手术中基本上以心脏的速率泵送血液进行心脏外科手术。Arnold系统暂时代替患者的心脏和肺并且以心脏的速度,通常5到6升/分钟泵送血液。与所有的绕过心脏和肺的系统相似,需要一个充氧器。当然,使用包括充氧器比如传统的心-肺机的任何系统,患者都不能移动。
利用早期的IABP设备,把一只聚亚胺酯气球安装在血管的导管上,插入股动脉,并且位于主动脉降中正好在左锁骨下动脉的远侧。将气球导管连接到一个泵控制台上,向该气囊泵送氦或二氧化碳,在心脏舒张期使气囊膨胀。在等容收缩的时候,例如,在主动脉瓣关闭和左心室继续收缩的短暂的时间,迅速地撤消用来操作气球的气体使气球缩小。当主动脉瓣打开时这就降低了在主动脉根的压力。反之,在心脏舒张的时候,使气球膨胀,引起心脏舒张压增加并且把主动脉的血液向远处推向身体的下一部分(气球的一侧)和向基部推向心脏和冠状动脉(在另一侧)。
这样一种反搏设备的主要优点是在心脏收缩期压缩,降低主动脉内的体积和压力,减少了两者的后负荷和心肌的氧消耗。换言之,当气球膨胀,它在主动脉人为产生一种较高的压力,对通过冠状动脉的灌注有裨益。当气球缩小,正好在主动脉瓣打开之前,主动脉压力和体积减少,减轻了心脏的一些血液动力学负担。这些生理反应改善患者的血液动力学情况,否则患者的血液动力学就有可能迅速地恶化。当有证据表明心脏具有更有效率的泵送能力,和患者的血液动力学情况得到改善,就可以中止反搏,慢慢地中断同时监视恶化情况。
在1979以前,所有的IABP导管都是通过外科造口术,通常是经股动脉插入的。自那时以后,一种经皮IABP导管的开发使得插入更迅速,并也许更安全,结果造成临床应用的治疗和开展建立更加迅速。然而,气球的膨胀和缩小,需要一个气动的泵,该泵必须足够大到能离体使用,从而限制了患者的运动,并不能进行正常的日常活动。因此,IABP设备就局限于短期使用,只有几天到几周。
如上所述,已经配置了多种心室辅助泵送系统。通常与LVAD相关的是用于入口和出口导管的阀门以确保血液单向流动。
如果在心脏的近处,必需是单向流动以避免不慎回流进心脏。使用这样的阀门也能使该LVAD设备的形成血栓的可能性减到最少。
通常,与老式的LVAD相关的泵是推板式或隔膜式的脉动流动泵,例如分别由Baxtor Novacor或TCI制造的泵。如果泵是移植在胸腔和/或腹腔内部,需要大的侵入手术。泵通常通过经皮动力传动系统驱动,该动力传动系统被一个起监视和重新编程作用的便携外部的控制台控制。
或者是,已经使用于心脏辅助系统的旋转泵,例如离心泵或轴流泵。利用离心泵,实际上血液在相同的平面进入和离开泵。相反,轴流泵沿着转子旋转的轴导引血液。虽然其他的泵配置较大,但通过阿基米德螺旋灌输,已经使轴流泵的配置小型化到大约一个铅笔擦的尺寸。虽然尺寸小,轴流泵可以足够强大产生接近老式的LVAO产生的流动,然而,通常经主动脉瓣或通过心室的顶部把泵引进左心室,并且其作用必须通过经皮管道从外部的控制台来控制。
上述所有的这些心脏辅助系统起到一个或两个目的:(1)把患者的起作用-但-患病的心脏从分类为NYHAC IV级的最小性能改善到分为I或O级的几乎正常的性能,或(2)向患者补充充氧的血液循环来满足器官的需求,这时患者需要大量的能量、体积和热消耗。
许多心脏辅助系统共有一些常规特征:1)设备实际上是心脏内型的,即,它们直接地放置在心脏内部或毗连心脏,或在与心脏(主动脉)相关的主要血管之一的内部,并且常常附到心脏和/或主动脉上;2)该设备试图复制在乳头的循环系统发现的自然脉动血液,因此,需要阀门以防止倒流;3)该设备由外部的控制台驱动,常常通过患者的心电图来触发控制;和4)血液泵的尺寸,包括其相关的连接器和附件,通常是接受者解剖学和生理学难处理的。由于具有一个或多个这些特征,现有技术的心脏辅助设备在其效力和/或实用性上是有限的。使用一种避免大的侵入手术而且避免使用严重限制患者行动的外围设备的心脏辅助系统将是有利的。
本发明的目的是克服现有技术的心脏辅助系统的缺陷,治疗泵功能的改变和循环动力学异常导致的CHF。本发明的系统不作为到患者的一个或多个器官的旁路,含有一个心脏外泵送系统,用来补充经患者的血液循环而不把它的任何元件连接到患者的心脏或主要血管。因此,它实际上是心脏外的。本发明能够应用最小侵入方法,显著改善了患者遭受CHF的病情,即使在CHF持续的时候也使患者感觉好得多了。本发明的一个辅助但是重要的益处是以这种方法应用本发明还能够降低心脏的泵送负荷,从而有可能使得心脏在使用时恢复。使用本发明,不需要体积大的泵、阀门或充氧器,也不需大心脏手术时的胸部侵入。实际上,本发明的显著特点是其简便性,同时还能达到改善患者遭受CHF病情的特定效果。
本发明的心脏外系统优选包括一台配置的旋转泵,以亚心脏的速度即,以较低于患者心脏的速率泵送血液;其他类型的泵也可以是同样有效的。通过从泵释放给血液动能和势能,泵送血液有助于使血液得到一种程度的恢复。重要的是,同现有技术配置的以心脏速率泵送的泵相比,本发明的泵送系统优先的的泵是一个需要相对地低的能量输入的泵。泵可以被移植或不被移植,这取决于性能,实用性,或患者是否移动的需要。
本系统还包括一个结合到泵的液体流入导管,以引导血液从第一个外围血管到泵中,和一个结合到泵的液体流出导管,以引导血液从泵到第二外围血管中。流入导管和流出导管与血管的连接是在皮下进行的;不象大的侵入手术那么深。换言之,是最小限度的皮下。这就允许用一个最小限度-侵入的方法应用本连接。优选,与血管的连接正好在皮肤下面或正好在第一层肌肉的下面,这取决于所连接的血管或连接的位置,虽然对某些患者而言稍微深的穿透可以是必要的。
在本心脏外系统的一实施方案中,泵是一个连续流动泵和/或脉动泵,可以被移植并被用来连接两个外围动脉,例如在流入端的股动脉和在流出端的腋动脉,虽然也可以使用其他外围血管,包括其他的动脉和/或静脉,而且可以是它们中单个和/或多个组合。一种可选的实施方案应用一台旋转泵,该泵可以是以同步式共搏或反搏式,或一些异相过渡方式控制的。在一个应用中,试图应用本发明使得心脏收缩时在主动脉根经受一个降低的压力,从而减少在心脏的血液动力学负担,从而,使心脏得到恢复。
当移植本发明的整个系统时,试图使它在皮下移植,而不需进行大的侵入手术,优选是在胸腔外。例如,可以在腹股沟部位移植泵,把流入的导管连接到临近的股动脉或回肠动脉,流出导管连接到肩部附近的腋动脉。试图通过在皮肤下穿过流出导管把泵连接到腋动脉。在移植处,优选用可移植的电池驱动泵,该电池可以被RF感应系统体外再充电或定期替换。
本发明还包括一种补充患者的血液循环的方法,有可能降低对患者心脏的泵送负荷,而不把任何足见与患者的心脏连接。发明方法包括移植一个配置好的泵以亚心脏平均体积速率泵送血液,其中泵具有与它连接的流入和流出导管;利用最小限度的侵入外科手术方法把流入导管的远端的连接到第一个外围血管使得血液从患者第一个外围血管流动到泵中;皮下移植流入导管;利用最小限度侵入外科手术方法把流出导管的末端连接到第二外围血管使得血液从泵流动到患者的第二外围血管;操作上述泵以使血液灌流经过患者的循环系统。在具体的应用中,泵可以被同步控制,其中操作泵的步骤包括在等容收缩的时候开始把血液放出泵,并且在心脏收缩后动脉瓣关闭时停止流出血液。取决于患者和本系统的具体的安排,具体的方法导致心脏的后载荷降低同时也补充循环。例如,在一个实施方案中,第一和第二血管分别是股动脉和腋动脉。
在本发明应用的一个可选方法中,泵没有被移植,流入和流出导管经皮连接到第一和第二血管,使用一个易于移动的连接管,例如套管来把每个导管的末端连接到血管中。
本发明的一个重要的优点是它利用一种IABP的益处,而不要求离体设备或需要气球或部分地阻塞血管类似的器具。从而本发明具有简便性并能长期使用。
附图简述
将参照附图描述本发明的这些和其他特征和优点,附图是用来举例说明,并不限制本发明的范围。
图1是被称为左心室辅助设备的心脏辅助设备的示意图,从图中可以看到从左心室顶部到主动脉弓有一个旁路;
图2是本发明第一个实施方案应用到一个患者的循环系统的示意图;
图3是本发明第二实施方案应用到一个患者的循环系统的示意图;
图4是图2所示移植到患者的第一个实施方案的变化的示意图;
图5是本发明第三实施方案应用到一个患者循环系统的示意图;
图6是本发明第四实施方案应用到一个患者的循环系统的示意图。
现在来看在此处提供的附图,下面提供了一个更详细描述的实施方案。然而,应该注意到,尽管某些实施方案具有在此处确定的所有的优点,但是其他的实施方案只能实现某些优点而不是所有的的优点。
本发明提供一个实际上是心脏外的心脏辅助系统。换言之,本发明补充血液灌注,不需要直接地与心脏和主动脉接口。从而,使用本发明不需要大的侵入外科手术。在某些情况,本发明也通过减少心脏收缩期在主动脉根的压力减少心脏的血液动力学负担。
参照图2所示,向有生病的心脏14和主动脉16的患者应用本发明的第一个实施方案,从其外围头臂血管延伸,包括右锁骨下动脉18,右颈动脉20,左颈动脉22,左腋窝动脉24。从主动脉降延伸的是另一组外围血管,左和右股动脉26,28。
第一个实施方案10包括用来连接弹性导管的有入口34和出口36的泵32。泵32优选是旋转泵,或者是一种轴流型或离心型的,虽然也可以使用其他的类型的泵,不论市售的的或定制的。在任一情况下,泵应该充分地小,以进行皮下移植并优选在胸腔外进行皮下移植,例如在患者的腹股沟区,不需要大的侵入手术。因为本发明是一种心脏外系统,不需要阀门。任何通过泵和/或流入导管的不慎的回流都不会伤害患者。
无论选择什么类型,调整本发明的泵32的尺寸,以亚心脏体积速率泵送血液,低于健康的心脏流动速率的平均值的大约50%,虽然上面的流动速率也可能是有效的。从而,本发明的泵32被调整尺寸和配置以每分钟0.1到3公升的范围体积流动速率流出血液,这取决于心脏辅助所需要的应用和/或需要的程度。
例如,对一个经受严重充血性心力衰竭的患者可以优选使用亚心脏平均速率为每一分钟2.5到3公升的泵。对其他的患者,特别地是那些最低的级别的心力衰竭,优选使用分钟0.5公升或较少的亚心脏平均速率的泵。
在一个实施方案中,选择的泵是一台连续流动泵以使血液连续通过循环系统灌注。在可选的实施方案中,选择的泵能够同步开动即,可能以脉动的方式开动,或者以共搏或反搏式的。对于共搏作用,通常试图在心脏收缩的时候使泵32开动流出血液,例如,在等容收缩时主动脉瓣打开之前或当主动脉瓣打开时开始开启。在心脏收缩之后同时主动脉瓣关闭时,例如,主动脉瓣关闭的时候泵是静态的,停止开动。这样一个应用将使得冠状的血液灌注增强。在这种应用中,试图使主动脉瓣打开之后心脏收缩的平衡是静态的,以减少心脏必须泵送的负担。主动脉瓣打开包括正在打开和正在关闭的时期,其中血液是流动的。
应该意识到配置的共搏和反搏是常见的,并且不限定为泵开始和停止启动时的患者心脏周期具体的点。较适合的,特别通指泵的启动,其中,泵至少部分地,分别地在心脏收缩和心脏舒张时启动。例如,试图触发泵以与本文描述的真正的共搏或反搏异相,并且仍然是同步的,这取决于患者的具体的需要或想要结果。一个可以替换的泵刺激来在先开始,在等容收缩之前或之后或以在等容膨胀之后或之前。
通常,当患者的心脏不规律地跳动时,可能需要异步脉动泵,这样由心脏外泵送系统泵送的血液就较规律。此外,可以驱动脉动泵与患者心脏异步脉动,很想搏动泵异步方式以使血液通过心脏外泵更规则灌注,从而,更有效地为器官充氧。当患者的心脏有规律地跳动,但是较弱,优选同步脉动心脏外泵。
泵被电动马达40驱动并且优选被一个可编程的控制器42控制,该控制器能够以脉动的方式开动,当需要时,也可控制泵的速度。对于同步控制,优选用EKG监测患者的心脏,由控制器42提供反馈。优选使用外部的工具编程控制器42。这可以例如使用通常在可移植的起搏器和去颤器内部使用的RF遥感勘测型电路实现。基于周围传感器监视的参数反馈,例如血压或患者KKG,控制器也可能是自动调节的,以允许泵速度自动调整和/或泵同步调整或同步的脉动。如果需要的话,也可以使用反向泵,其中控制器能够反转泵马达或叶轮的方向。当需要时使用这样的泵以选择改变具有反转两个外围血管之间的循环方向。
马达40和控制器42的动力由电池44提供,该电池优选是通过一种外部感应源(未示出)可再充电的,例如一种与电池电磁耦合的RF感应线圈以在其中感应充电。在再充电的时候泵可以暂时停止而对生命没有可感知的威胁效果,因为系统只是辅助心脏,而不是代替心脏。
尽管优选预先把控制器42和电池44装配到泵32并一起移植,也可以试图在某一位置移植泵32和马达40并且把控制器42和电池44移植在另一个位置。在一个可选的安排中,泵32可以通过一个经皮动力传动系统在外部驱动。在另一可选的配置中,泵,马达和控制器可以移植并且由一个离体电池供给动力。在后一种的情况下,电池可以附加在患者的侧边以允许完全地移动。
泵32的入口34优选连接到一个弹性流入导管50和一个弹性流出导管52上以把血液从一根外围血管引导到另一根血管。流入导管50和流出导管52可以是,例如,由涤纶,Hemashield或Gortex材料形成,虽然其他的材料也可以是适合的。在某些情况下,附加到泵的流入和/或流出导管可以是已经市售的。在需要移植泵32和导管50,52时,优选导管内径低于25毫米,虽然直径稍大也将是有效的。
在本发明优先的的应用中,第一个实施方案应用在动脉的-动脉的方式;例如,作为股动脉-腋动脉旁路,如图2所示。本技术领域的普通的技术人员应该理解在此处描述使用的本实施方案腋-股旁路也将是有效的。实际上,本技术领域的普通的技术人员应该意识到本发明可以应用到患者的任何外围血管。
流入导管50有一个与泵32入口34相连的第一个近端56和与第一个外围血管优选是患者12的左股动脉26连接的第二个远端58,虽然右股动脉或任何其他的外围动脉也是可接受的。在一个应用中,流入导管50和第一个血管之间通过末端-到-侧边交叉合流连接(anastomosis),虽然可以使用导管中流的-侧边-到-侧边交叉合流连接,其中,流入管在第二末端与另一根血管连接(未示出)。
同样,流出导管52有一个与泵32出口36相连的第一近端62,和与外围血管相连的第二远端64,外围血管优选是患者的左腋动脉24,尽管右腋动脉或其他外围血管也可以接受。在一个应用中,在流出导管52和第二血管之间的连接经末端-对-侧面交叉合流连接,尽管可以使用导管中游进行侧面-到-侧面连接,其中,流出导管第二末端还与另一根血管相连(未示出)。最好是,流出导管以某一角度连接于第二血管,使从泵出来的绝大部分血流几乎都流向主动脉和心脏,如图2所示。
优先皮下进行把本发明应用到外围血管;即,正好在皮肤第一层肌肉下面的浅处以避免大的侵入手术。还优选在胸腔外应用本发明以避免侵入患者胸腔的必要。
当需要时,本发明10的整个心脏外系统可以移植在患者12的内部。在这种情况下,可以把泵32移植到腹股沟区域,在皮下把流入导管50与临近泵32的股动脉26相连接。流出导管将在皮下穿到例如左腋动脉24中。在可选的安排中,泵32和相关的驱动和控制器可以临时固定到患者的外部皮肤上,流入和流出导管50,52经皮连接。在任一情况下,患者都是可以移动的而不受管线的限制。
当不需要交叉合流连接时,可以使用特定连接管来把导管50,52连接到外围血管上。参照图3,示出了本发明的第二实施方案,其中通过第一和第二连接管68,70把流入导管50和流出导管52连接到外围血管上,每个连接管包括三通配件。在优先的实施方案中,连接管68,70包括一个在血管内的,通常为T字形的的配件72,该配件72有一个近端74,一个远端76,和一个角分歧78,使得连接到流入和流出导管50,52和血管上。配件72的近端74,和远端76使得血管连接到配件所在的位置。
配件72的分歧78的角可以是与经过血管的流动轴成90度或较少。在另一实施方案中,连接管68,70是环绕和附着于外围血管外部的套管(未示出),在套管内部,提供了一个到血管的接口,使导管50,52的血液流动,这时它们分别地被连接到连接管68,70。其他的配置的其他的类型的连接管也可以避免交叉合流连接的需要或使得导管连接到血管上。试图通过套管进行与血管的连接,在其中套管和流入和流出导管一起移植。
分散的连接管的优点是它们潜在应用到有慢性CHF的患者上。当期望多次除去和/或代替本系统时,连接管消除了在本发明导管和外围血管之间交叉合流连接的需要。连接管可以半永久地应用的到第一和第二血管,具有用到分歧的端盖用于稍后把本发明系统连接到患者上。从这一点考虑,患者可能定期地受到本发明的益处,不需要每次都从交叉合流的血管处不重新连接或断开进行连接。每次在执行本发明时,迅速去除端盖,并把导管迅速地连接到接管。
在接管70的优先的实施方案中,分歧78被以与配件72的轴成低于90度的锐角导向的,如图3所示,这样大部分血液经流出导管52进入流向心室14的方向的血管(例如,左腋24),而不是流向外侧。在一种可选的实施方案中,本配件72的近端74的直径可以比末端76的直径大,不需要有角分歧,以获得相同的结果。
不管有或没有连接管,由于把血液流动往近端引导向主动脉,可以同时并发顺降主动脉向下的流动,造成主动脉根压力的减少。因此可以应用的本发明补充血液循环,以降低患者心脏的后负荷,即使不能使心脏完全恢复,也至少能恢复一部分。并发的流动取决于脉动的泵的操作相和与流出导管连接的第二血管的选择。
尽管可以应用本发明以产生一种动脉-动脉的旁路,考虑到本发明的性质,即,补充循环以满足器官的需求,可以同时使用静脉-动脉的旁路。例如,参照图4,本发明10一个实施方案可能应用到患者12,使得流入导管50连接到外围静脉例如左股静脉80上。以这安排,流出导管50可能连接到一个外围动脉上,例如左腋24。动脉-静脉的安排也同样好。在静脉的-动脉的病例中,当流入连接到到一个静脉上并且流出连接到一个动脉上,泵32应该调整尺寸以使得流动充分地小,这样在动脉中氧-不足的血液就不能增加到无法接受的水平。应该理解与外围静脉的连接可以是由上面描述的用于连接外围动脉的一个或多个方法。应该理解到本发明可以应用为静脉的-静脉的旁路,其中流入和流出连接到单独的外围静脉。另外,一种可选的实施方案包括两个分散的泵和导管安排,一个用作静脉-静脉旁路,和另一个用作一种动脉-动脉旁路。
尝试了本发明的一个部分外部应用,其中患者的心脏急性衰退,并且被认为不能维持很长时间,或者是在心脏衰退的早期(其中患者被纽约心脏分类协会(New York Heart Association Classification,NYHAC)功能分类为II或III)。参照图5,本发明110的第三实施方案被经皮应用到患者112到在两外围血管之间的旁路,在其中离体使用泵132和它的相关的马达和控制器。泵132有相关的流入导管150和流出导管l52,用于连接两个外围血管。流入导管150有一个第一个末端156和第二末端158,在其中第二末端经由套管180连接到第一个外围血管(例如,股动脉126)。套管180有一个第一个末端182,可密封连接到流入导管150的第二末端158。套管180也有一个第二末端184,用于经过外科开口186刺穿皮肤或第一层肌肉和刺穿到血管源(例如,股动脉126)。
类似地,流出导管152有一个第一末端162和第二末端164,其中第二末端经由一个套管180被连接到第二外围血管(例如,左腋动脉124)。与流入套管相似的,流出套管180有一个可密封的连接到流出导管152的第二末端164的第一个末端182。流出套管180也有第二末端184,用于经过外科的开口190刺穿皮肤或第一层肌肉刺穿到第二血管(例如,左腋动脉124)。通过使用一种经皮应用,本发明可以临时应用,而不需要任何方面的移植或交叉合流连接到血管上。
可以使用第三实施方案的可选的变化,其中需要周期性地治疗患者,但每次的时间短并且不使用特定的连接管。利用这种变化,通过,例如,一种交叉合流连接,试图把流入和流出导管的第二端更永久地连接到到相关的血管,其中,经皮移植与血管临近的导管的一部分和患者体外导管的外露的第一末端(或一种其插入末端)可移动的端盖,当需要提供一个循环的旁路以补充血液流动,在每一暴露的经皮-位置导管可移动的端盖可以是可移走并且泵(或附加在其上有一定长度的流入和/或流出导管的泵)被插在暴露的经皮导管之间。在这点上,患者可以周期性地受到本发明的益处,而不必每次从血管重新连接和重新断开导管。
本发明另一实施方案包括多个流入和/或流出导管。例如,参照图6,本发明的第四实施方案210包括一台与多个流入导管250A,250B和多个流出导管252A,252B液体沟通的泵232。每一对导管在通常为Y-形会聚处296会聚,在流入末端合流和在流出末端分流。每一导管可以连接到单独的外围血管,虽然是也可能,有两个连接到远处的相同血管。在一个安排中,所有的四个导管被连接到外围动脉。或者是,可以把一个或多个导管连接到静脉。在图6所示应用中,流入导管250A连接到左股动脉226,同时流入导管250B被连接到左股静脉278。流出导管252A被连接到左腋动脉224同时流出导管2528被连接到左颈动脉222。应该注意到与血管连接的任何或所有的导管都可能通过上述交叉合流连接或一个特定连接管连接。另外,可以把图6的实施方案应用到最适合患者病情的一些外围血管的任何组合上,反之亦然。最后,应该注意到多于两个导管可以被使用为流入或流出一侧,而且流入导管的数目不必等于流出导管的数目。
上面的描述解释了本发明多样的实施方案应用的一些发明特征,应当理解普通的技术人员可以进行本装置或方法形式和细节变化,而不偏离本发明的精神。本发明的范围通过未决的权利要求书表明,而不被前面的描述说明。
Claims (10)
1.一种用于补充患者身体内的血液循环的心脏外泵送系统(10),所述泵送系统(10)包括一个为将血液泵经患者体内而配置的泵(32),一个流动连接于泵(32)上引导血液流向泵(32)的流入导管(50),和一个流动连接于泵(32)上引导血液流出泵(32)的流出导管(52),所说的心脏外泵送系统(10)的特征在于:
泵送系统(10)以对患有充血性心力衰竭的患者补充血液循环的方式配置,其任何元件都不与患者的心脏相连;
所述泵(32)的平均流速为0.1-3.0升/分钟,其中,所述泵在其正常操作时的平均流速比患者心脏健康时的流速显著低,并且所述泵以用亚心脏体积速率泵送血液流经患者的方式配置;
所说的流入导管(50)的内径小于25毫米并具有第一末端,所述第一末端的尺寸和构造适于连接第一外围血管(26);以及
所说的流出导管(52)的内径小于25毫米并具有第一末端,所述第一末端的尺寸和构造适于连接第二外围血管(24)。
2.如权利要求1所述的系统,其中泵(32)被配置来能在维持时间周期内以低于约2.5升/分钟或以下的平均体积速率来循环血液。
3.如权利要求1所述的系统,其中泵(32)是脉动泵,以及其中该系统还进一步包括一控制电路(42)以同步驱动泵(32),以便在等容收缩期内开始泵送并在主动脉瓣关闭时中断泵送。
4.如权利要求1所述的系统,其中泵(32)是脉动泵,以及其中该泵送系统还包括一个控制电路(42)以在舒张期内同步驱动泵(32)和在主动脉瓣打开时泵的驱动,从而在第一和第二外围血管(24,26)之间提供反搏血流。
5.如权利要求1所述的泵送系统,其中泵(32)、流入导管(50)和流出导管(52)是这样设计尺寸和配置的,即,使能通过使用一种最小侵入的外科手术方法进行移植。
6.如权利要求5所述的系统,进一步包括一可植入的电池(44)。
7.如权利要求6所述的系统,进一步还包括一感应线圈,该感应线圈被配置来与电池(44)电磁耦合,以在植入所述电池(44)和泵(32)之后来使电池充电。
8.如权利要求1所述的系统,还包括一个连接管(70),连接管(70)用来固定到外围血管(24,26)中的一个上并用来连接到导管(50,52)中的一个上。
9.如权利要求1所述的系统,还包括至少一个附加的流入导管(250B),流入导管(50,250B)中的每一个都具有被配置来连接到外围血管(24,26)上的第一末端。
10.如权利要求1所述的系统,还包括至少一个附加的流出导管(252B),流出导管(52,252B)中的每一个都具有被配置来连接到外围血管(24,26)上的第一末端。
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US09/166,005 US6200260B1 (en) | 1997-10-09 | 1998-10-02 | Implantable heart assist system |
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1998
- 1998-09-10 UA UA2000041978A patent/UA56262C2/uk unknown
- 1998-10-02 US US09/166,005 patent/US6200260B1/en not_active Expired - Lifetime
- 1998-10-09 CN CNB988099918A patent/CN1211132C/zh not_active Expired - Fee Related
- 1998-10-09 KR KR1020007003855A patent/KR100544944B1/ko not_active IP Right Cessation
- 1998-10-09 DE DE69820466T patent/DE69820466T2/de not_active Expired - Lifetime
- 1998-10-09 BR BR9814060-4A patent/BR9814060A/pt not_active IP Right Cessation
- 1998-10-09 ES ES98952225T patent/ES2210835T3/es not_active Expired - Lifetime
- 1998-10-09 CA CA002305443A patent/CA2305443C/en not_active Expired - Fee Related
- 1998-10-09 RU RU2000107816/14A patent/RU2203686C2/ru not_active IP Right Cessation
- 1998-10-09 EP EP98952225A patent/EP1021218B1/en not_active Expired - Lifetime
- 1998-10-09 WO PCT/US1998/021424 patent/WO1999019010A1/en active IP Right Grant
- 1998-10-09 IL IL13520998A patent/IL135209A0/xx not_active IP Right Cessation
- 1998-10-09 AU AU97976/98A patent/AU728804B2/en not_active Ceased
- 1998-10-09 CZ CZ20001173A patent/CZ295454B6/cs not_active IP Right Cessation
- 1998-10-09 JP JP2000515640A patent/JP4115666B2/ja not_active Expired - Lifetime
- 1998-10-09 AT AT98952225T patent/ATE255923T1/de not_active IP Right Cessation
-
1999
- 1999-04-09 US US09/289,231 patent/US6428464B1/en not_active Expired - Lifetime
-
2000
- 2000-04-25 US US09/558,445 patent/US6299575B1/en not_active Expired - Lifetime
-
2004
- 2004-12-22 JP JP2004372152A patent/JP4532256B2/ja not_active Expired - Lifetime
-
2010
- 2010-02-23 JP JP2010037404A patent/JP5676118B2/ja not_active Expired - Lifetime
Also Published As
Publication number | Publication date |
---|---|
US6428464B1 (en) | 2002-08-06 |
BR9814060A (pt) | 2000-09-26 |
KR20010031038A (ko) | 2001-04-16 |
EP1021218A1 (en) | 2000-07-26 |
JP4532256B2 (ja) | 2010-08-25 |
CA2305443C (en) | 2003-12-16 |
US6299575B1 (en) | 2001-10-09 |
KR100544944B1 (ko) | 2006-01-24 |
ATE255923T1 (de) | 2003-12-15 |
CZ20001173A3 (cs) | 2000-08-16 |
IL135209A0 (en) | 2001-05-20 |
CN1274293A (zh) | 2000-11-22 |
AU9797698A (en) | 1999-05-03 |
UA56262C2 (uk) | 2003-05-15 |
ES2210835T3 (es) | 2004-07-01 |
JP2010148901A (ja) | 2010-07-08 |
AU728804B2 (en) | 2001-01-18 |
JP2005095667A (ja) | 2005-04-14 |
JP5676118B2 (ja) | 2015-02-25 |
JP2003520611A (ja) | 2003-07-08 |
DE69820466T2 (de) | 2004-10-28 |
CA2305443A1 (en) | 1999-04-22 |
EP1021218B1 (en) | 2003-12-10 |
DE69820466D1 (de) | 2004-01-22 |
RU2203686C2 (ru) | 2003-05-10 |
WO1999019010A1 (en) | 1999-04-22 |
CZ295454B6 (cs) | 2005-08-17 |
US6200260B1 (en) | 2001-03-13 |
JP4115666B2 (ja) | 2008-07-09 |
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