CN110461449A - 体外血液回路 - Google Patents
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Abstract
本公开涉及用于血液中的气体交换的体外血液回路,特别是用于心肺分流术的回路。
Description
技术领域
本公开涉及用于血液中的气体交换的体外血液回路,特别是用于心肺分流术的回路。
相关技术的描述
心肺分流术(CPB)常用于对患者的心脏或肺进行的各种外科手术中。实例包括冠状动脉搭桥手术、心脏瓣膜修复和/或置换、大间隔缺损的修复、先天性心脏缺陷的修复和/或缓解、移植、肺动脉血栓内膜剥脱术或肺血栓切除术。机器泵送血液,并且使用氧合器允许红细胞获得氧,以及允许二氧化碳水平降低。这分别模仿心脏和肺的功能。CPB使血液机械地进行全身循环并为身体血液充氧,同时绕过心脏和肺部。当外科医生在无血手术区工作时,其使用心肺机(HLM)来维持对其他身体器官和组织的灌注。
在外科手术过程中,必须通过例如超滤从患者体内除去过量的水。在心肺机上,血液过滤器常用于该目的。
体外膜氧合(ECMO),也称为体外生命支持(ECLS),是一种体外技术,其为心脏和肺部无法提供足够量的气体交换以维持生命的人提供心脏和呼吸支持。ECMO通过从人体内去除血液并人为地去除二氧化碳和为红细胞充氧来起作用。在静脉-动脉(VA)ECMO中,该血液返回到动脉系统;在静脉-静脉(VV)ECMO中,血液返回到静脉系统。
在体外血液循环期间,产生炎症介质如细胞因子和内毒素,其可导致全身性炎症反应。多年来已经开发了多种措施来减少炎症释放。最近,已经提出将捕获细胞因子的吸附柱整合到体外回路中。
发明内容
本公开内容提供了一种体外回路,其中将超滤和炎症介质的吸附组合在单个装置中。
详细说明
提供了一种体外血液回路,其包括气体交换装置和扩散和/或过滤装置。扩散和/或过滤装置包括半透膜,该膜包括i)丙烯腈和甲基烯丙基磺酸钠的共聚物;ii)聚乙烯亚胺;和iii)肝素。在本公开的体外回路的一个实施方案中,扩散和/或过滤装置是包括多个半透性中空纤维膜的毛细管透析器,该膜包括:i)丙烯腈和甲基烯丙基磺酸钠的共聚物;ii)聚乙烯亚胺;和iii)肝素。
毛细管透析器的血液隔室(其包括中空纤维膜的内腔)连接到体外血液回路。换句话说,在体外血液回路的操作期间,体外血液回路中的血流通过毛细管透析器的血液隔室并因此通过中空纤维膜的内腔,这与透析器的常规设置相同。
包括半透膜的扩散和/或过滤装置是本领域已知的,该膜包括:i)丙烯腈和甲基烯丙基磺酸钠的共聚物;ii)聚乙烯亚胺;和iii)肝素。
US 2003/0021826 A1公开了将抗凝剂以稳定的方式结合到半透膜的表面上,该半透膜基本上由丙烯腈和至少一种阴离子和可阴离子化的单体的共聚物组成。公开了一种半透性复合膜,其包含半透性支持膜和适于通过体外循环处理血液或血浆的抗凝剂,所述半透性支持膜基本上由携带有阴离子或可阴离子化的基团的聚丙烯腈构成;旨在用于与血液或血浆接触的半透性支撑膜的表面依次涂覆有携带有阳离子基团的阳离子聚合物和携带有能够与所述阳离子聚合物的阳离子基团形成离子键的阴离子基团的抗凝剂(例如肝素),其中阳离子基团可与聚丙烯腈的阴离子或可阴离子化的基团形成离子键,阳离子聚合物(例如聚乙烯亚胺,PEI)包含足以不穿过半透性支撑膜的链尺寸。
WO 2007/148147 A1描述了在优选基于丙烯腈和甲基烯丙基磺酸钠的共聚物的膜上使用携带有阴离子或可阴离子化的基团的聚合物的胶体形式和酸性介质中的溶液,特别是通过例如将携带有阴离子或可阴离子化的基团的聚合物溶液与有机多元酸溶液以相对于所述聚合物的特定比例进行混合,这导致接枝到膜表面的聚合物的量和在该膜涂层的表面上的游离的阳离子或可阳离子化的基团的可用性增加。所述膜允许结合携带有阴离子或可阴离子化的基团的大量化合物。建议用于治疗败血综合征,特别是用于吸附生物流体中含有的内毒素,用于通过体外循环纯化血液或血浆中含有的某些分子,和用于在体外血液或血浆处理期间减少患者的全身抗凝。WO 2007/148147 A1中还描述了制备膜的方法。
扩散和/或过滤装置通过超滤从患者体内去除过量的水,并且还从患者的血液中吸附炎症介质。合适的扩散和/或过滤装置的实例包括可从Gambro Lundia AB以商品名和获得的商业毛细管透析器。
包含AN69型膜的现有产品的一个实例是Evodial透析器,其是配备有基于肝素接枝的丙烯腈的膜(如上述WO 2007/148147 A1中所述的,所谓的HeprAN膜)的血液透析器。Evodial膜的特征还在于,源自阴离子磺酸盐基团的带电表面被聚阳离子生物聚合物聚乙烯亚胺中和。表面处理还允许通过肝素的负电荷和阳离子聚合物的游离正电荷之间的非常强的离子结合而将所述肝素几乎不可逆地固定。具有固定肝素能力的膜是非常需要的,因为它进一步降低了对肝素全身剂量的需要。
在体外血液回路的一个实施方案中,扩散和/或过滤装置的膜包括每平方米膜表面积10至100mg,例如25至50mg的聚乙烯亚胺以及每平方米膜表面积1,500至10,000UI,例如3,000到6,000UI,例如4,500±1,500UI的肝素。
在一个实施方案中,扩散和/或过滤装置包括中空纤维膜,其内径为180至260μm,例如210μm或240μm。在一个实施方案中,中空纤维膜的壁强度为30至60μm,例如40至50μm。在一个实施方案中,扩散和/或过滤装置中膜的总表面积为1至3m2,例如1.0至2.2m2。
在一个实施方案中,当在37℃下在蛋白质含量为60g/l的牛血浆中测量时,扩散和/或过滤装置中的中空纤维膜显示以下筛分系数:对于菊粉,>0.95;对于肌红蛋白,>0.55;对于白蛋白,<0.01。
扩散和/或过滤装置中的膜具有通过吸附将炎症介质和内毒素固定到其表面的显著能力。在一个实施方案中,在具有QB=400ml/min,QD=700ml/min且UF=100ml/min的HDF模式中,对IL-6的清除率为20至40ml/min。
本公开的体外血液回路还包括气体交换装置。气体交换装置在患者的血液中进行气体交换,即,它从血液中除去二氧化碳和/或为血液充氧。在体外回路的一个实施方案中,气体交换装置是膜式氧合器。膜式氧合器在本领域中是已知的,并且市场上有各种各样的装置。膜式氧合器包括半透性聚合物膜。合适的聚合物的实例包括聚丙烯、聚乙烯、聚-4-甲基戊烯(PMP)、聚偏二氟乙烯(PVDF)和聚四氟乙烯(PTFE)。在另一个实施方案中,气体交换装置是鼓泡式氧合器。鼓泡式氧合器也是本领域已知的,并且是可商购的。
在一个实施方案中,本公开的体外血液回路是心肺分流术(CPB)。在一个实施方案中,心肺分流术是静脉-动脉分流术。在另一个实施方案中,心肺分流术是静脉-静脉分流术。在一个实施方案中,体外血液回路包括心肺机(HLM)。在另一个实施方案中,体外血液回路被配置用于体外膜氧合(ECMO)。在一个实施方案中,体外血液回路被配置用于静脉-动脉(VA)ECMO。在另一个实施方案中,体外血液回路被配置用于静脉-静脉(VV)ECMO。
本公开还涉及包括半透膜的扩散和/或过滤装置在心肺分流术或ECMO中的用途。该膜包括:i)丙烯腈和甲基烯丙基磺酸钠的共聚物;ii)聚乙烯亚胺;和iii)肝素。在一个实施方案中,扩散和/或过滤装置是毛细管透析器,其包括多个半透性中空纤维膜。在一个实施方案中,心肺分流术包括膜式氧合器。在进一步的实施方案中,心肺分流术包括心肺机。
当来自患者的血液通过本公开的体外回路时,气体交换装置从血液中除去二氧化碳和/或为其充氧,即向其补充氧气。炎症介质和内毒素被扩散和/或过滤装置吸附;通过超滤从血流中抽出水。本公开的体外回路的优点在于,使用单个扩散和/或过滤装置实现了炎症介质和内毒素的去除以及过量水从患者体内的去除。这极大地简化了体外回路的组装和操作。假设与仅用血液过滤器去除过量水的心肺分流术相比,炎症介质和内毒素的额外去除对需要CPB的外科手术的结果产生积极影响。
对于本领域技术人员显而易见的是,在不偏离本发明的范围和精神的情况下,可以对本文公开的发明进行各种替换和修改。
通过非限制性实施例说明本发明,所述实施例在附图中进一步详述,以进一步促进对于本发明的理解。
实施例
测试有效表面积为1.5m2的毛细管透析器(Gambro Lundia AB)对于炎症介质和内毒素的去除。透析器包括中空纤维膜,其包含丙烯腈和甲基烯丙基磺酸钠的共聚物。纤维表面包含30mg/m2的高MW聚乙烯亚胺(PEI)并用4,500±1,500UI/m2的肝素接枝。纤维的内径为240μm,壁强度为40μm。
白细胞介素-10(IL-10;MW=18kDa)、白细胞介素6(IL-6;MW=26kDa)、高迁移率族蛋白1(HMGB-1;MW=30kDa)和肿瘤坏死因子α(TNF-α;MW=51kDa)用作细胞因子。脂多糖(LPS;MW>100kDa)用作内毒素。
使用500ml用[25-75]EU/ml的LPS理论浓度稳定化的来自健康志愿者的、蛋白质含量为60±5g/l的冷冻的人血浆池进行体外实验。在循环开始之前,分别以500pg/mL、1,500pg/mL、30ng/mL和250pg/mL的浓度掺入IL-10、IL-6、HMGB-1和TNF-α细胞因子。
选择了n=3的多个样本(包括n=3多个批次),已经发现这足以证明全身去除机制,并且考虑到与内毒素/细胞因子去除相关的临床结果可能根据患者的病理状况而显著不同(预见的细胞因子吸附量与血浆最终循环细胞因子水平之间没有直接的临床相关性)。循环条件代表标准的CRRT实践。
在血浆池循环之前,用1.5L肝素化(5UI/mL)的盐水溶液以150ml/min洗涤透析器的血液隔室。使用额外的500ml溶液,通过超滤来冲洗透析液隔室。
将血浆池以150ml/min闭环循环120分钟。在循环期间,在基线和在t=5、t=10、t=30、t=60和t=120min时,直接从血浆池进行取样。
使用匹配的抗体对和重组体(Quantikine R&D system,France;和IBLinternational,Germany,用于人HMGB-1),通过酶联免疫吸附测定(ELISA)一式两份地测量细胞因子的浓度。通过鲎变形细胞溶解物(LAL)显色方法(K-QCL Lonza测定)一式两份地测量LPS浓度。
使用以下公式计算每个介质在循环结束(t=120min)时的去除率规格:
RR(t=120min)=[1-C(t=120min)/C(t=0min)]x 100
其中
C(t=0min):血浆池中的初始浓度(基线样本)
C(t=120min):t=120min时,血浆池中的最终浓度
结果总结在表1中。
表1:在t=120min时对IL-10、IL-6、HMGB-1、TNF-α细胞因子和LPS的平均计算去除率
体外实验证实了膜对所考察的不同细胞因子(IL-10/IL-6/HMGB-1和TNF-α)以及内毒素LPS的高亲和力。这些观察结果似乎与现有的临床证据一致,表明该装置具有选择性消除炎症介质和相关的改善患者状况(改善SOFA评分和心血管功能)的能力。
Claims (11)
1.一种体外血液回路,其包括
a)气体交换装置;和
b)包含多个半透性中空纤维膜的毛细管透析器,所述膜包括:i)丙烯腈和甲基烯丙基磺酸钠的共聚物;ii)聚乙烯亚胺;和iii)肝素,所述透析器的血液隔室包括与体外血液回路连接的半透性中空纤维膜的内腔。
2.根据权利要求1所述的体外血液回路,其中所述气体交换装置是膜式氧合器。
3.根据权利要求1或2所述的体外血液回路,其中所述体外血液回路是心肺分流术(CPB)。
4.根据权利要求3所述的体外血液回路,其中所述血液回路包括心肺机(HLM)。
5.根据权利要求1至3中任一项所述的体外血液回路,其中所述体外血液回路被配置用于体外膜氧合(ECMO)。
6.根据权利要求3所述的体外血液回路,其中所述心肺分流术是静脉-动脉分流术。
7.根据权利要求3所述的体外血液回路,其中所述心肺分流术是静脉-静脉分流术。
8.包括半透膜的扩散和/或过滤装置在心肺分流术中的用途,所述膜包括:i)丙烯腈和甲基烯丙基磺酸钠的共聚物;ii)聚乙烯亚胺;和iii)肝素。
9.根据权利要求8所述的用途,其中所述扩散和/或过滤装置是毛细管透析器,所述毛细管透析器包括多个半透性中空纤维膜。
10.根据权利要求8或9所述的用途,其中所述心肺分流术包括膜式氧合器。
11.根据权利要求8至10中任一项所述的用途,其中所述心肺分流术包括心肺机。
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