CN1268894A - 心内血泵 - Google Patents
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- A61M60/126—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
- A61M60/148—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
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Abstract
心内血泵(10)有一个驱动部分(11)和一个泵部分(12)。在泵部分(12)上连接一个挠性的泵软管(14)。为了从右心房(21)向肺动脉(26)布置泵软管(14),在泵软管(14)的远端设有一个气囊(35),此气囊在血流中充当引导元件,并被自然血流推动。以此简化了血泵在心脏中的安放。
Description
本发明涉及一种心内血泵,尤其是涉及这样一种血泵,它可以经邻接的血管完全地进入心脏,以支持心脏的自然泵血功能,或者通过连续的泵运转替代心脏的自然泵血功能。
WO94/09835(Jarvik)专利文件描述了一种用于支持心脏的泵装置。该泵装置有相互独立的泵,它们各由一个泵部分和一个与之牢牢连接的驱动部分组成。一个泵的泵部分经过一个尖穿的手术开口穿过,如此导入左心室,使它从左心室出来送入主动脉。另一个泵部分从另一个优选的尖穿的手术开口穿过,如此导入右心室,使它从右心房出来进入肺动脉。这些泵各在其泵出口由一个管形出口细管延长,这些出口细管可被导过相应的心脏瓣膜。
由WO97/37696(Ran等)公开一种从主动脉穿经主动脉瓣导入左心室的心内泵。在这种情况下,泵入口通过一个管子延长,该管穿过主动脉瓣。
由WO97/37697(Rau等)公开一种血管内血泵,它可以通过血管推移。该血泵也在其入口端通过一根抽吸管延长。此抽吸管带有一个可充气的气囊,气囊起阻塞装置的作用,以从侧面阻滞经过抽吸管的血流。
最后,由美国专利4 753 221(Kensey等)公开一种泵导管,它有一个用于植入心脏的泵。此泵由一个叶轮和一个包围此叶轮的泵壳组成。该泵壳可以塌缩的状态植入心脏,然后通过给一个与该泵壳相连接的气囊充气而使之膨胀起来。
另外,公知为了诊断目的,用小内径导管去探测血压和血流量,在导管远端有一个可充气的气囊。此气囊用于把导管顶端置入肺动脉。
对于穿经血管导入心内血泵,有难于把血泵准确地放置在心脏内的问题。尤其是,如果把血泵经过上腔静脉导入,以从右心房向肺动脉内泵血时,难于正确地放置血泵,因为必须要把血泵进行近180度的掉头,从而使抽吸口放在右心房中,泵出口放在肺动脉内。此外,在右心室内有许多腱束,它们固定三尖瓣,防止帆状瓣被击穿并保证心脏形状稳定。经腔静脉导入的血泵须穿过这些腱束。
本发明的目的是,创造一种相对容易地放置在心脏内的心内血泵。
此目的的解决方案是根据本发明以权利要求1指出的特征实现。
在根据本发明的血泵中,在泵出口接有一个挠性软管,其远端有一个在血流中起引导元件作用的气囊。本发明利用这样的情况,就是心脏中的自然血流由腔静脉入右心房,经过右心室导入肺动脉。在软管远端装有一个气囊的血泵恰沿此途径导入,从而在血流中漂浮着的气囊自动地找到其由右心房至肺动脉中去的路径。在泵部分处在右心房中时,软管的出口紧接着被稳定在肺动脉中。泵软管在此时经有一个近于180度的弯曲。以此方式实现把血泵(包括泵软管)准确地放置在心脏中,用不着试探着把软管出口碰触心室壁,也不需要诊断性辅助装置(X光机、超声波仪)。
本发明意义上的心内包括心室、心房以及邻接脉管端段。
如果按其在心内最终占据的位置,把泵软管预先弯曲是适宜的。这要求至少弯曲150度左右。为了穿过腔静脉导入,泵软管必须能够伸直,但是在松弛状态它应该为U字型或者V字型。如果泵软管有一个从近端向远端减小的抗弯曲强度是特别有优越性的。以此方式,此远端可作为探路器轻易地被运动,从而使气囊较好地顺血流而行。
气囊不必直接安在泵软管上。它也可以固定在一根导管上,导管是泵软管的组成部分,并从内或外通过泵软管。无论如何必须有一个管腔通向气囊,经它可以为气囊充气。还可以设计附加的第二管腔,其中导入一根引导线,以方便泵软管经脉管***推进。抽出引导线之后可以把第二管腔用作血压测量通路。
根据一个优选的实施例,气囊包绕泵软管成为环形气囊。环形气囊的优点是,通过气囊,软管远端外径加大,并由此固定在肺动脉瓣上。以此方式,在软管出口处在肺动脉中时,气囊帮助把软管管端固定在肺动脉瓣上。以此防止软管出口从肺动脉滑脱。另一个优点在于,环形气囊形成泵软管的一个倒圆的末端,从而不会由泵软管引起对血管和心壁或者心脏其它部分的伤害。最后还防止软管端在心脏内挂在瓣膜壁或者腱囊上。
因为泵部向泵软管内泵血,自动地保持泵软管开启。此处泵软管可用一个其壁形不稳定的、可塌陷的软管,例如薄膜软管。一根导管可穿过此软管通向安置在远端的气囊。
对于带有挠性泵软管的心内血泵,存在一个危险,即从软管出口流出的血液对软管形成一个反冲,会造成软管向回推移。以此方式可发生软管从肺动脉瓣滑脱的现象。为此,本发明的另一个目的是创造一种避免有该液压反作用力引起软管位移的心内血泵。
根据本发明,这个目的由权利要求13的特征完成。按此,在软管的远端固定一个受泵出血流冲击的牵引元件。在该牵引元件上可以有一个蓬或者是一个气囊。从软管出来的血流冲击在该牵引元件上,从而产生一个与软管的反作用力对抗作用的前向的力。以此方式,该牵引元件起稳定泵软管定位的作用。
下面参照附图简述本发明的实施例。其中;
图1为心脏的横截面图,带有安装在其中的血泵;
图2为图1中的血泵图示;
图3为图2的局部III的截面图;
图4为血泵的第二实施例;
图5为第三实施例;而
图6为图5实施例中导管的放大示意图。
根据图1的血泵10是一种血管内血泵,也就是说,一种可以经过患者的血管***推移,以***到心脏中的血泵。这种血泵的外径在最细处大于8mm。泵10有一个驱动部分11和一个与其牢牢连在一起的泵部分12。此泵与WO97/37696所述的泵相应,因此其内部结构本文不再讲述。在驱动部分11和泵部分12之间的过渡区域有一个吸入孔13,经此孔径向地从外面吸入血液。泵部分12含有一个在轴向上驱动血液的叶轮(图中未示)。在泵部分12的泵出口上接有一个泵软管14。此软管有一个与泵出口连接的近端15和一个构成软管出口的远端16。
泵10的近端连接一根导管17,该导管还含有一个为驱动部分11供电的电源线。另外导管17还有一个空腔,它可以接在一个压力气源上。
泵软管14和导管17是挠性的。泵10的刚性部分长度不超过35mm,以此该泵可以穿经血管***的弯曲道。泵软管14的长度至少是泵的刚性部分长度的两倍。泵软管长度约12cm,外径约8mm,其壁厚约0.05mm至0.2mm。软管弯曲的曲率半径为40mm至60mm。
在图1中表示心脏20的一个横截面。下腔静脉22和上腔静脉23汇入右心房21。在右心房21和右心室24之间有三间瓣25。在右心室24的肺动脉26之间有肺动脉瓣27。血液从肺动脉26流向肺,并从肺流回到左心房28中再流向左心室29。在左心室29和主动脉30之间是主动脉瓣31。
泵10被布置为右心泵,它从右心房21送入肺动脉26,为此,在图示的实施例中是通过上腔静脉23安放的。还可以经过下腔静脉22安放。在导入泵10时,泵软管14在此泵前方,也就是说它在顺着泵10流动、包围此泵的血流流动方向上。
在泵软管14的远端16有一个气囊35,此气囊根据图2和图3形成为环行气囊。这个用气体(例如空气、氦气、二氧化碳)或者液体膨胀起来的气囊35的外径大于泵软管14的外径。因此,气囊35形成一个引导元件,自然血流作用在其上,以牵引引导元件。这样,气囊35在自然血流通道上,先冲入右心室24,然后冲入肺动脉26。
通过在泵软管14的压力腔36中产生压力使气囊35膨胀。压力腔36经孔37与环行气囊35连通。在泵软管14中,血液经由血流腔38流动,血液腔的横截面远大于压力腔36的横截面。压力腔36连接在近导管17端的相应的压力腔上,从而,其压力可以在体外控制。
在图2中表示泵软管14为松弛状况。泵软管预弯为U字形或V字形,也就是说它具有形状记忆力,从而根据图1所示,它在心脏中不会受到什么约束,而且从它这方面也不会对心脏施加什么约束。在图2中,打点区域的灰度指示出泵软管14的硬度。在近端15此硬度很大,然后向远端16递减。这意味着,在其上有气囊35的远端16可以通过气囊***和引导。
由图3可见,气囊35在远端突出于泵软管14的末端39,使气囊35形成一个倒圆的软管末端40,它没有挂在障碍物上的危险。在气囊35的近端,它形成一个环状的后切迹41,肺动脉瓣27的尖端可以***其中,如图1所示,从而肺动脉瓣阻止软管末端的回缩。
如图2和3所示,在软管出口42上绷着一个圆顶蓬形的牵引元件43。该牵引元件43由一个薄的挠性膜组成,它与桥片44固定在气囊35上。从软管出口42流出的血液流向牵引元件43,并以此在泵软管14上作用一个与反冲作用相对的牵引力。从而防止泵软管的远端16由于液压反冲作用而移动并可能发生从肺动脉瓣27滑出。
泵软管14优选地由胺酯制造,此材料被证明为特别适用。
在图4的实施中,在泵10上接一个泵软管14a,它含有一个以碳或者金属制的螺旋线形式的弹性支撑结构45。该支撑结构45保持泵软管张开,并且产生所要求的抗弯强度,此抗弯强度还可在软管长度上变化。一个导管46穿过泵软管45,在导管的远端设有一个气囊35a。此气囊构成泵软管14a的引导元件。导管46含有一个压力腔。导管外径远小于泵软管14a的直径,从而在泵软管中为血流提供足够的横截面。导管46与导管17连接。
作为牵引元件43a,一个小球安排在软管42后面相隔一段距离并固定在导管46上。压向牵引元件43a的血流阻止远端的软管末端16向泵10回缩。泵软管14a用一个止动装置47固定在牵引元件43a上。
在图5和图6的实施例中。泵软管14b是一个可松塌的泵软管,由没有自身形状稳定性的薄膜材料制造。一根导管48穿经泵软管14b走行,该导管48的远端带有一个气囊35a。此导管48与导管17连接。泵软管14b的远端16连接导管48,而且泵软管14b有一个血液流出的出口49。按照图5,在引入泵时,泵没有工作,从而泵软管14b是松塌的。借助于气囊35a把软且有挠性的导管48放入心脏并定位泵软管14b。接着使泵运转,这样使泵软管扩张。
为了易于放置,按照图6,导管48除了包括导向气囊35a的压力腔49之外,还可以含有另一个腔50,用于容纳一个引导线51,并在取走此引导线之后用于体外测定压力。同样穿过导管17和泵10的引导线51能使手术人员控制泵软管的布置。然后抽出引导线51。
根据图6,可以在导管48上设一个与腔50相连并被引导线51堵住的开口52。从腔50抽出引导线51之后,血液经孔52流入腔50中。腔50可以与一个血压表相连,以此,测量泵血时肺动脉的血压,并在必要时对之施加影响。
由于安置泵软管时不带有引导线,从而可以借助于可测的在另一个腔50中的压力分布,在位置52测量压力,由压力分布可以测量远端的泵软管管端的准确位置。
气囊的直径不应该过大,以免严重阻碍流经肺动脉26的血流,或者甚至堵塞肺动脉。一般,此直径不应大于30毫米。另外,有别于伸展气囊,所述的气囊应当有较高的弹性。气囊的材料,出于弹性的关系,宜采用硅橡胶、乳胶,并优选地采用聚胺酯。
作为导管软管的引导元件在血流中漂浮时,气囊可用高压力大大地扩张,然后通过释放压力而缩小,用以起受泵出血液冲击的牵引元件的作用。
Claims (13)
1.心内血泵,带有一个径向吸吮和轴向输送的泵部分(11),此泵部分连接一个导管(17),还有一个与此泵出口连接的挠性泵软管(14),该泵软管有一个与泵出口邻接的近端(15)和一个构成软管出口的远端(16),其特征在于,泵软管(14) 在其远端附近有一个被血流运送的、起引导元件作用的气囊(35)。
2.根据权利要求1的心内血泵,其特征在于,泵软管预先弯曲100°以上,优选地预弯曲150°左右。
3.根据权利要求1或2的心内血泵,其特征在于,泵软管(14)有一从近端(15)向远端(16)递减的抗弯曲强度。
4.根据权利要求1至3之一的心内血泵,其特征在于,泵软管内或外有一根导管(46;48),它突出于泵软管的远端(16),并在其远端侧带有一个气囊(35a)。
5.根据权利要求1至3之一的心内血泵,其特征在于,气囊(35)环绕泵软管(14)成为环形气囊。
6.根据权利要求5的心内血泵,其特征在于,环形气囊形成一个圆形的软管前端(40)。
7.根据权利要求1至6之一的心内血泵,其特征在于,泵软管(14b)是一个可松塌的软管。
8.根据权利要求1至7之一的心内血泵,其特征在于,泵软管(14a)包含有一个弹性支撑结构(45)。
9.根据权利要求1至8之一的心内血泵,其特征在于,泵软管(14b)有一个导管(48),以及在导管(48)中设有一个可以导入的引导线(51)。
10.根据权利要求1至9之一的心内血泵,其特征在于,导管(48)中有一个用于放置引导线(51)的空腔(50)和一个压力腔(49)。
11.根据权利要求1至10之一的心内血泵,其特征在于,导管(48)有一个可用作压力测量腔的空腔(50)。
12.根据权利要求1至11之一的心内血泵,其特征在于,气囊的直径在气囊充起的状态下不大于30mm。
13.心内血泵,有一个用于径向吸吮并轴向输送的泵部分(11),此泵部分连接一个导管(17),还有一个与此泵出口连接的挠性泵软管(14),该泵软管有一个与泵出口邻接的近端(15)和一个构成软管出口的远端(16),其特征在于,在泵软管(14)的远端(16)固定有一个受泵血流冲击的牵引元件(43)。
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DE19821307A DE19821307C1 (de) | 1998-05-13 | 1998-05-13 | Intrakardiale Blutpumpe |
DE19821307.7 | 1998-05-13 |
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CN99800718A Pending CN1268894A (zh) | 1998-05-13 | 1999-04-24 | 心内血泵 |
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- 1999-04-24 AT AT99920778T patent/ATE288771T1/de not_active IP Right Cessation
- 1999-04-24 EP EP99920778A patent/EP0996472B1/de not_active Expired - Lifetime
- 1999-04-24 CN CN99800718A patent/CN1268894A/zh active Pending
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- 1999-04-24 IL IL13363199A patent/IL133631A0/xx unknown
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- 1999-04-24 US US09/446,770 patent/US6544216B1/en not_active Expired - Lifetime
- 1999-04-24 AU AU38228/99A patent/AU749458B2/en not_active Expired
- 1999-04-24 PL PL99337993A patent/PL337993A1/xx unknown
- 1999-04-24 KR KR1020007000104A patent/KR20010021546A/ko not_active Application Discontinuation
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Also Published As
Publication number | Publication date |
---|---|
EP0996472A1 (de) | 2000-05-03 |
AU3822899A (en) | 1999-11-29 |
KR20010021546A (ko) | 2001-03-15 |
DE19821307C1 (de) | 1999-10-21 |
PL337993A1 (en) | 2000-09-25 |
WO1999058170A1 (de) | 1999-11-18 |
CA2295951A1 (en) | 1999-11-18 |
IL133631A0 (en) | 2001-04-30 |
AU749458B2 (en) | 2002-06-27 |
JP2002514472A (ja) | 2002-05-21 |
EP0996472B1 (de) | 2005-02-09 |
DE59911583D1 (de) | 2005-03-17 |
US6544216B1 (en) | 2003-04-08 |
NO996232D0 (no) | 1999-12-16 |
ATE288771T1 (de) | 2005-02-15 |
NO996232L (no) | 2000-03-13 |
JP4163384B2 (ja) | 2008-10-08 |
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