CN109843348A - 用血泵和氧合器进行体外膜氧合的系统 - Google Patents
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Abstract
在用于体外膜氧合的系统中,所述系统包括血泵和氧合器,所述氧合器包括堆叠在壳体中并且彼此平行地布置的纤维垫子,并且所述血泵包括控制单元,该控制单元提供流量随时间的连续变化。
Description
技术领域
本发明涉及一种用于用血泵和氧合器进行体外膜氧合的系统,其中,血泵包括允许流量随时间连续变化的控制件。
背景技术
流量随时间的连续变化被认为意指流量的非由于血泵的接通和断开所引起的变化。它也不被认为意指由于血泵的类型所引起的流量变化,诸如例如在滚压泵或者还有离心泵的情况下,这些泵由于它们的设计而不会产生绝对连续的流。
流量随时间的连续变化是由外部影响对泵的控制而导致通过流量变化来控制泵的控制相关的重叠引起的。通过这种方式,例如可以产生脉动流,其像在较长时间上振荡的正弦曲线或矩形脉冲那样引起流量的变化。然而,基于与患者身体的当前状况匹配的测量,可以使体积流量变化,这些体积流量变化又优选地与心跳周期性地匹配,确定限定的体积流率或限定的体积流量变化。
通过流量的变化,用于体外膜氧合的系统的操作可以适于患者的当前心脏状况。可以实施医生确定的与连续体积流量的偏差(特别是在幅度和/或波长的变化方面),并且还可以使用血泵的脉动控制件来释放陷在系统中的气泡以便使系统更快地排气。
例如,从DE 102013012433A1已知此类系统。
对于这些系统,如EP 0765689中所描述的装置被用作氧合器。这使得有可能使血液富含氧并以简单的方式使其达到正确的温度。这些氧合器还对血泵上出现的压力峰值进行缓冲。
这种类型的系统通常经由插管连接到人的血液循环,特别是连接到心脏。布置在心脏中的插管上的出口处的脉动性应当对应于由医生精确地预定的脉动性。由于测量心脏中的插管出口处的脉动性将是费力的,因此在泵出口处测量血液的流动值,并且相对于血泵、氧合器和插管的系统,医生估计在设置泵控制件时,心脏中的插管出口处将出现什么样的脉动性。
发明内容
本发明的目标是进一步开发此类系统。
根据第一方面,根据本发明,系统的氧合器包括堆叠在壳体中的具有纤维的垫子,所述纤维彼此平行地布置。
血液可以垂直于堆叠的垫子流动通过这种类型的膜式氧合器,然后表现出特别小的压力下降。这导致与在氧合器处测量的血液的流动行为有关的值在很大程度上对应于心脏中的插管出口处的值。
由于通过氧合器的脉动性血液流几乎不改变,因此氧合器之前的脉动性几乎精确地对应于氧合器之后的脉动性。这能实现系统出口处的脉动的血液流以及同时血液在系统内的泵处的平缓加速。
特别有利的是这样一种形式的实施例,即其中控制件连接到ECG。这使得有可能直接地或以经处理的形式将用ECG测量的值用于控制血泵。通过这种方式,在最简单的情况下,由ECG测量的周期可以用于用于控制泵。另外,使ECG值偏移使得能够进行系统控制以便经由血泵确定心脏处的流动行为。
本发明的另外的方面涉及转子的设计。具有转子的血泵已证明是特别有利的,该转子的外直径小于4 cm,优选地小于3.5 cm,并且具有大于1 cm的直径。上述小型转子导致小的泵壳体。另外,通过减小转子直径,其惯性矩减小。这使得有可能特别快速地改变转子速度,以便实现体积流量随时间的特殊流量分布。较大的转子直径可产生较大的压力以克服阻力。然而,此类大型转子必然是缓慢和不精确的。通过特殊的惯性矩,所提出的转子直径能实现针对脉冲的最佳定时。这对于使用任何类型的氧合器都是有利的。特别是结合堆叠在壳体中的具有彼此平行地布置的纤维的垫子,当血液流动通过系统向上通过心脏中的插管出口时,该流量分布在很大程度上保持不变。
因此提出,血泵包括转子,惯性矩小于5000 g/mm2,并且优选地小于1000 g/mm2。为了保证血泵的运行,其惯性矩大于200 g/mm2。在转子具有约660 g/mm2的惯性矩的情况下,取得了积极的结果。
有利的是,血泵具有转子,该转子经由磁体连接到使转子围绕轴线旋转的致动器,其中,磁体布置成距轴线处于5至10 mm的平均距离处。一方面,这导致磁体的运行被优化,其应当从而应只轻微地增加转子的惯性矩,并且另一方面允许转子和马达之间经由磁体的良好联接。
最重要的是合适,因为血泵是仅具有小的径向流部分的血泵。因此提出,血泵具有产生轴向流部分的转子。特别地,这些是轴向或对角泵。
氧合器的特别有利的设计设想,使垫子之前的血液流入部的截面增加,以便降低血液的流速。在通往氧合器的途中,这使得有可能将血液输送到具有小线直径和高流动速度的氧合器,并且在血液所流入其中的垫子之前不久降低血液的速度,因为在那里可用于流动的截面大大增加。
因此,也可以在流动通过的垫子之后减小血液流入部的截面,以便增加血液的流速。
表示本发明的另外的方面的实施例的特殊形式设想,压力释放装置布置在泵与氧合器之间。以这种方式,可以拦截压力峰值以便减小泵和/或氧合器的机械负载。压力释放装置优选地沿流动方向布置在泵和氧合器之间。具有气垫的均衡容器(equalisationvessel)或由柔性材料制成的线路可以用作压力释放装置。此类柔性线路可以短暂地扩张,以便通过增加截面来拦截压力峰值。
然而,还可以通过柔性的或柔性地支承的血液分配板来实现压力释放。此类血液分配板具有防止直接流动到中空纤维的附加优点。
还提出,压力释放装置包括具有气垫的均衡容器或具有至少一个柔性壁区域的线路。
对压力波动进行缓冲的另一种可能性是将氧合器中的垫子可移动地保持在框架中。特别地,如果氧合器的垫子被可移动地保持在框架中,则有利的是,框架相对于壳体保持可移动。通过这种方式,垫子最终相对于壳体可移动,其结果是,可以实现对短暂压力峰值的缓冲。
更特别地,体积流量随时间的变化与在必要的情况下仅对体积流量峰值的轻微缓冲的组合导致了保护垫子的有效通流。
还实现了紧凑的结构和对血液的保护性处理,因为血泵和氧合器之间的连接线路的长度小于20 cm,优选地小于15 cm,并且特别优选地小于5 cm。因此,血泵和氧合器被布置成尽可能彼此靠近,并且优选地甚至保持在同一壳体中。
通过垫子的不同实施例以及特别是通过垫子相对于彼此的布置,产生了其他优点。因此,最初设想,垫子从一个平面到下一个平面以与彼此成90°的角度布置。该角度描述了支承在彼此顶部的垫子的主要流动方向之间的角度。
还提出,垫子为矩形并且优选地在设计上是二次的。
实施例的另外的形式设想,氧合器包括圆柱形壳体,垫子平行于该圆柱形壳体的正交截面圆形区域布置在所述圆柱形壳体中。
产生了简单的结构,因为氧合器具有中心入口并且优选地还具有中心出口。替代地,氧合器还可以具有偏离中心的入口和偏离中心的出口。
特别优选的实施例变型设想,氧合器具有气泡传感器。这使得有可能直接在氧合器处确定系统中存在的气体,以便在必要的情况下通过流量的变化(例如,通过切换到脉动流入)将气体排出氧合器。
取决于使用目的,产生了有利的实施例变型,因为氧合器位于泵的下游或泵位于氧合器的下游。
附图说明
在附图中示出了并且在下文将更详细地解释实施例的有利形式。此处
图1示出了圆形氧合器,其具有用于进口和出口的中心连接件,
图2示意性地示出了具有偏离中心的入口和出口的圆形氧合器,
图3示意性地示出了具有偏离中心的入口和出口的角形氧合器,
图4示意性地示出了具有中心连接件和控制件的圆形氧合器,
图5示意性地示出了具有偏离中心的连接件的圆形氧合器,
图6示意性地示出了具有中心连接件的角形氧合器,
图7示意性地示出了在没有磁体的情况下在泵的转子下方正交于泵的转子轴线的剖平面中的剖面,
图8示意性地示出了在具有磁体的情况下图7中所示的剖面,以及
图9示意性地示出了具有中心连接件和均衡容器的圆形氧合器,所述中心连接件具有渐增的截面。
具体实施方式
图1中所示的系统1包括圆形氧合器2和泵3。由箭头4和5指示的流动方向表明:流最初穿过泵3,然后穿过氧合器2。氧合器2具有壳体6,具有中空纤维的示意性地指示的垫子7堆叠在该壳体中。
氧合器2具有作为第一连接件的中心入口9和作为第二连接件的中心出口8。
图2示出了类似的构造,其中氧合器10具有直接连接到泵13的偏离中心的入口12以及具有偏离中心的出口11。
图3示出了另外的氧合器14,其包括中心入口16和偏离中心的出口15,并且其壳体17在设计上是二次的。
图4示出了图1中所示的圆形氧合器2的俯视图,其具有被覆盖的中心连接件8和与控制件18连接的血泵3,该控制件使得流量有可能随时间而连续变化。控制件18与示意性地指示的ECG 19连接。
图5和图6以示意性地类似构造分别示出了构造根据图2和图3的系统的视图—但是这些系统分别具有血泵20和21,所述血泵分别借助于22和23连接到圆柱形氧合器24和二次氧合器25。
图7示出了转子26的下侧,其具有大约2.5或3 cm的外直径27。磁体与轴线29的5mm的较小平均径向距离用箭头28指示,并且10 mm的较大平均径向距离用箭头30指示。
若干磁体31、32、33和34作为小型圆磁体片布置在环35中。4至8个小磁体片抑或环形磁体可以被用作磁体。这些小磁体片围绕轴线29同心地布置在壳体36内并且形成磁体系统37,致动器(未示出)的力通过该磁体系统传送到转子26。
在图6中,示意性地指示了具有气泡传感器38的氧合器25。
图9示出了来自氧合器40的出口39,该出口在氧合器之后不久以漏斗形的方式变宽,使得血液流到氧合器中的垫子的速率慢于在氧合器之后的线路中的速率。因此,沿流动方向,入口可以设置在氧合器之前,该入口以漏斗状的方式变宽以便保护流所指向的板。此类漏斗状入口或出口适合于任何类型的氧合器,以便降低氧合器中的流速并由此保护流动所指向的板。
图9还示出了均衡容器41,气垫设置在该均衡容器中以便对系统中的波动压力进行缓冲。此类均衡容器41可以布置在系统的任何点处,并且优选地布置在氧合器附近。
附图示出了通过系统的流,其中血液首先流动通过血泵,然后流动通过氧合器。然而,所述流还可以沿相反方向穿过系统,使得血液首先流动通过氧合器,并且在其后流动通过血泵。
Claims (21)
1.一种用于体外膜氧合的系统(1),所述系统具有血泵(3、13)和氧合器(2、10),其中,所述血泵(3、13)包括使得流量有可能随时间连续变化的控制件(18),所述系统的特征在于,所述氧合器(2、10)包括堆叠在壳体(6)中的具有纤维的垫子(7),所述纤维彼此平行地布置。
2.根据权利要求1所述的系统,其特征在于,所述控制件(18)与ECG(19)连接。
3. 根据特别是权利要求1至2所述的系统,其特征在于,所述血泵(3、13)包括转子(26),所述转子的外直径(27)小于4 cm,优选地小于3.5 cm。
4. 根据前述权利要求中任一项所述的系统,其特征在于,所述血泵(3、13)包括转子(26),所述转子的惯性矩小于5000 g/mm2,并且优选地小于1000 g/mm2。
5. 根据前述权利要求中任一项所述的系统,其特征在于,所述血泵(3、13)包括转子(26),所述转子通过磁体(31至34)与使所述转子(26)围绕轴线(29)旋转的致动器连接,其中,所述磁体(31至34)布置成距所述轴线(29)处于5至10 mm的平均径向距离(28、30)处。
6.根据前述权利要求中任一项所述的系统,其特征在于,所述血泵(3、13)包括转子(26),所述转子引起轴向流部分。
7.根据前述权利要求中任一项所述的系统,其特征在于,压力释放装置布置在所述血泵(3、13)与所述氧合器(2、10)之间。
8.根据权利要求7所述的系统,其特征在于,所述压力释放装置包括具有气垫的均衡容器(41)。
9.根据权利要求7所述的系统,其特征在于,所述压力释放装置包括具有至少一个柔性壁区域的线路。
10. 根据前述权利要求中任一项所述的系统,其特征在于,所述血泵(3、13)与所述氧合器(2、10)之间的所述连接线路(22、23)小于20 cm,优选地小于15 cm,并且特别优选地小于5 cm。
11.根据前述权利要求中任一项所述的系统,其特征在于,所述流动所指向的在所述垫子之前的所述血液入口(39)的截面被扩大,以便降低所述血液的流速。
12.根据前述权利要求中任一项所述的系统,其特征在于,所述氧合器的所述垫子以可移动的方式被保持在框架中。
13.根据权利要求12所述的系统,其特征在于,所述框架相对于所述壳体以可移动的方式被保持。
14.根据前述权利要求中任一项所述的系统,其特征在于,所述垫子以从一个平面布置到下一个平面成90°的角度布置。
15.根据前述权利要求中任一项所述的系统,其特征在于,所述垫子为矩形并且优选地在设计上是二次的。
16.根据前述权利要求中任一项所述的系统,其特征在于,所述氧合器(2、10)具有圆柱形壳体,所述垫子平行于截面圆形区域布置在所述圆柱形壳体中。
17.根据前述权利要求中任一项所述的系统,其特征在于,所述氧合器(10)具有偏离中心的入口(12),并且优选地还具有偏离中心的出口(11)。
18.根据前述权利要求中任一项所述的系统,其特征在于,所述氧合器(2)具有中心入口(9),并且优选地还具有中心出口(8)。
19.根据前述权利要求中任一项所述的系统,其特征在于,氧合器(25)具有气泡传感器(38)。
20.根据前述权利要求中任一项所述的系统,其特征在于,所述氧合器(3、13)位于所述血泵(3、13)的下游。
21.根据前述权利要求中任一项所述的系统,其特征在于,所述血泵位于所述氧合器的下游。
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DE102016006013.1A DE102016006013A1 (de) | 2016-05-18 | 2016-05-18 | System für die extrakorporale Membranoxygenierung mit einer Blutpumpe und einem Oxygenator |
DE102016006013.1 | 2016-05-18 | ||
PCT/DE2017/000116 WO2017198244A1 (de) | 2016-05-18 | 2017-04-27 | System für die extrakorporale membranoxy genierung mit einer blutpumpe und einem oxygenator |
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JP (1) | JP2019514628A (zh) |
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DE (2) | DE102016006013A1 (zh) |
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WO2021257347A1 (en) * | 2020-06-17 | 2021-12-23 | Tc1 Llc | Extracorporeal blood pump assembly and methods of assembling same |
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- 2017-04-27 CN CN201780044946.XA patent/CN109843348B/zh active Active
- 2017-04-27 DE DE112017002519.2T patent/DE112017002519A5/de active Pending
- 2017-04-27 ES ES17731799T patent/ES2867030T3/es active Active
- 2017-04-27 US US16/302,151 patent/US20190209760A1/en not_active Abandoned
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EP3895756A1 (de) | 2021-10-20 |
US20190209760A1 (en) | 2019-07-11 |
EP3458124B1 (de) | 2021-03-31 |
DE102016006013A1 (de) | 2017-11-23 |
CN109843348B (zh) | 2021-08-10 |
JP2019514628A (ja) | 2019-06-06 |
EP3458124A1 (de) | 2019-03-27 |
WO2017198244A1 (de) | 2017-11-23 |
ES2867030T3 (es) | 2021-10-20 |
DE112017002519A5 (de) | 2019-01-31 |
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