CN114849494B - 分子筛膜在制造ecmo设备中的应用 - Google Patents

分子筛膜在制造ecmo设备中的应用 Download PDF

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CN114849494B
CN114849494B CN202210158666.4A CN202210158666A CN114849494B CN 114849494 B CN114849494 B CN 114849494B CN 202210158666 A CN202210158666 A CN 202210158666A CN 114849494 B CN114849494 B CN 114849494B
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张玉亭
周跃
顾学红
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Abstract

本发明涉及分子筛膜在制造ECMO设备中的应用，具体涉及一种基于高硅(或全硅)分子筛膜肺材料的体外膜肺氧合(Extracorporeal Membrane Oxygenation，ECMO)技术。在ECMO过程中，患者血液中的二氧化碳通过所述膜肺材料与氧源气体发生气体交换实现血液氧合，由于采用的膜肺材料孔径规整、孔隙率高，膜肺的二氧化碳渗透率和分离选择性都非常优异；并且膜肺材料是高硅(或全硅)结构，因此具有很强的疏水性和很好的化学稳定性，有利于减少血渗现象和延长使用寿命，从而提高ECMO的安全性和降低膜肺的使用成本。

Description

分子筛膜在制造ECMO设备中的应用
技术领域
本发明涉及一种基于高硅（或全硅）分子筛膜肺材料的ECMO技术，属于分子筛膜应用技术领域。
背景技术
体外膜氧合技术（Extra-Corporeal Membrane Oxygenation，简称ECMO）俗称人工肺，通过将体内血液从静脉中抽出，流经膜肺氧合血红蛋白同时降低CO2浓度，氧合后的血液再输入体内达成循环。目前主要的膜肺材料是聚4-甲基-戊烯（PMP），价格昂贵且原料完全依赖进口，完全被国际公司垄断，因此开发新的膜肺替代材料十分重要。膜肺材料需要满足具有适当的孔径，血液相容性好，成本较低等要素。其中血液相容性是指血液对外源性物质或材料产生合乎要求的反应，一般是指材料与血液各成分之间的相容性。评价标准包括以下三个方面：防止血栓形成、凝血形成以及不妨碍血小板机能。关键在于血清蛋白在膜阵列上的吸附、血小板的粘附和激活以及血液的凝血动力学。否则会产生炎症反应、血栓形成、纤维化和感染。
发明内容
本发明提供了一种基于高硅（或全硅）分子筛膜肺材料的ECMO技术，具体涉及膜肺材料的种类、表面改性方法和气体分离性能，基于高硅（或全硅）分子筛的膜肺材料孔道规整、孔隙率高，用于ECMO过程中的CO2/O2交换表现出很高的的气体渗透率与分离选择性，且高硅（或全硅）分子筛的疏水性强、化学稳定性好，有利于减少血渗现象和延长膜肺的使用寿命，从而提高ECMO的安全性和降低膜肺的使用成本。
分子筛膜在制造ECMO设备中的应用。
所述的分子筛膜的材质是高硅或全硅分子筛膜。
所述的高硅或全硅分子筛膜的材质为MFI、DDR或者CHA分子筛膜。
所述的分子筛膜是以中空纤维作为构型。
所述的中空纤维的通道直径为0.1-3mm。
一种基于分子筛膜的ECMO设备，其中所使用的膜肺材料是高硅或全硅分子筛膜。
所述的高硅或全硅分子筛膜的材质为MFI、DDR或者CHA分子筛膜。
所述的分子筛膜安装于管壳式组件中，且壳程与泵血设备连通，管程与氧源气体源连通。
还包括：抗凝剂添加设备，用于向血液中添加抗凝剂。
所述的抗凝剂是柠檬酸钠。
有益效果
与大多数有机膜相比，高硅（或全硅）分子筛膜（例如MFI、DDR、CHA等分子筛膜）孔径规整、化学稳定性好、机械强度高，在CO2分离研究中表现出很高的气体渗透性和分离选择性。采用多孔陶瓷中空纤维作为载体制备分子筛膜，有利于提高膜的装填密度和降低膜的制备成本，便于实现膜肺的小型化和低成本。
基于高硅（或全硅）分子筛的ECMO膜材料，孔道规整、孔隙率高，气体渗透率高，CO2/O2分离选择性非常接近人体肺泡膜本身的扩散选择性。膜肺材料为高硅（或全硅）结构，疏水性强、化学稳定性好，能够减少血渗现象和延长使用寿命，并且能够承受高温或者紫外消毒杀菌处理，具有再生利用的可行性。与商品化膜肺材料相比，分离效率更高、使用寿命更长且具有可再生性。
附图说明
图1人工肺工作原理
图2 实验室用模拟气体交换流程图
实施方式
针对普通的分子筛膜会与血液发生血液相容性，CO2/O2分离选择性不高问题，本发明采用的是一种全硅疏水性分子筛膜。图1显示，整套人工肺作用装置是由气体搅拌器，氧合器（包括分子筛膜），以及真空泵组成。经由气体搅拌器之后的氧气与空气混合后由于具有压强梯度，两股气体进入氧合器中，经过氧合器中的膜之后气体发生分离，氧气进入血液相中经血流进入人体，参加其他循环，而循环后的废气经由泵的作用重新进入氧合器被膜吸附与氧气发生交换进入空气侧排出体外。
具体的运行过程如下：
(1) 贫氧的患者血液和氧源气体分别流入膜肺两侧，血液与膜表面接触后，血液中的CO2由膜侧经过膜肺的孔道扩散至载体侧，同时载体侧O2经过膜肺的微孔孔道扩散至膜侧的血液中发生氧合。
(2) 血液沿所述膜肺表面流动，通过血泵控制膜表面血液的剪切流速，同时通过流量控制器控制氧源气体的流量，获得优化的O2渗透速率和分离选择性。
(3) 参与血液循环时需要使用滤器放置于供血管路中，用于除去血栓成分。
图2显示，整套实验室用模拟气体交换流程图中，CO2与O2经质量流量控制器经鼓泡反应器和血液混合首先测试未进行气体交换时的含氧量，在经过膜组件气体交换后利用测试模块进行测试，再将气体交换后的血液中含氧量进行测试，P1为小型蠕动泵，用于使血液参与循环，V1为液体箱，B13、B14分别为CO2与O2，可以通过改变配比进行不同比例的交换。
具体的实验过程是：采用人工血液，以全硅疏水性分子筛膜（采用DDR膜，中空纤维载体）作为膜肺材料，调控O2分压5.0 kPa，CO2分压6.5 kPa，作为贫氧血；同时，调控O2分压13.0 kPa，CO2分压3.0 kpa，作为富氧血；变温器使整个体系的温度保持在410 K，进行气体氧合处理过程后，计算O2和CO2通量以及分离性能。
Figure SMS_1
表1显示，与3M公司的聚4-甲基-戊烯膜肺材料对比发现，基于全硅或高硅分子筛的膜肺材料机械强度高，CO2渗透通量和分离选择性高，有望成为替代的ECMO膜肺材料。另外，分子筛膜在分离过程中相对于商品化的膜肺材料来说具有更优异的运行稳定性，在运行56 h后，其主要分离运行参数如下：
Figure SMS_2
。

Claims (3)

1.一种基于分子筛膜的ECMO设备，其特征在于，所述的ECMO设备由气体搅拌器、氧合器以及真空泵组成；
氧合器中所使用的膜肺材料是全硅疏水性分子筛膜，所述的全硅疏水性分子筛膜是DDR膜；所述的分子筛膜的构型为中空纤维，中空纤维的通道直径为0.1-3mm；所述的分子筛膜安装于管壳式组件中，且壳程与泵血设备连通，管程与气体搅拌器连通；
经由气体搅拌器之后的氧气与空气混合后由于具有压强梯度，两股气体进入氧合器中，经过氧合器中的膜之后气体发生分离，氧气进入血液相中经血流进入人体，参加其他循环，而循环后的废气经由真空泵的作用重新进入氧合器被膜吸附与氧气发生交换进入空气侧排出体外。
2.根据权利要求1所述的ECMO设备，其特征在于，还包括：抗凝剂添加设备，用于向血液中添加抗凝剂。
3.根据权利要求2所述的ECMO设备，其特征在于，所述的抗凝剂是柠檬酸钠。
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