CN1071585C - 血液过滤和血浆过滤的装置和方法 - Google Patents
血液过滤和血浆过滤的装置和方法 Download PDFInfo
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- CN1071585C CN1071585C CN95191976A CN95191976A CN1071585C CN 1071585 C CN1071585 C CN 1071585C CN 95191976 A CN95191976 A CN 95191976A CN 95191976 A CN95191976 A CN 95191976A CN 1071585 C CN1071585 C CN 1071585C
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Abstract
公开了体外处理血的装置和方法，它们能有效地用于血浆过滤或血液过滤。该装置包括与平行板透析器(PPD)串联的空心纤维膜组件(HFD)。与对蓄液罐(104)施加交替的正压和负压作用相呼应，吸附剂袋(101)中的吸附剂悬浮液首先流入PPD的吸附剂入口(102)，再流出吸附剂出口(103)，而被引入蓄液罐(104)，再由蓄液罐(104)排出并通过单向阀(105)。然后该吸附剂悬浮液流入HFD入口(106)并通过HFD的外室，从而使该吸附剂悬浮液在搅拌混合作用下与HFD中空心纤维(107)的外表面接触。该吸附剂悬浮液从HFD出口(108)流出，经过血漏泄检测器(109)再返回到吸附剂袋(101)中。
Description
参考相关申请
本申请是一件美国专利申请的部分继续申请，原美国专利申请的序列号为07/832,080，1992年2月6日提交，现正待决。
发明背景
本发明广泛涉及体外处理血或血级分例如血滤液或血浆的装置和方法，该装置和方法用来选择性地去除血和血级分中的毒素。
作为背景，曾广泛地致力于发现安全而有效的方法，通过将患者的血进行体外处理以除去患者体内带有的毒素。上述努力包括许多针对传染、肝硬变、毒物损伤或其它原因引起的肝衰竭的体外处理方法所进行的研究。已提出了许多方法来去除那些认为能引起昏迷和肝衰竭病的小分子毒素、与蛋白质结合的分子或较大分子。迄今已经明显知道，引起有害作用的是那些未与蛋白质结合的小分子，例如氨、酚、硫醇、短链脂肪酸、芳族氨基酸、神经抑制剂(GABA，谷氨酸盐)、假神经传递质(真蛸胺)、和胆汁盐。其中酚和硫醇，与胆红素和细菌内毒素一起，还形成牢固的与蛋白质结合的毒素，因而更难以从血中有效地去除。此外，还有多种中等分子量的肝功能衰竭的毒素，其分子量为约300至约10,000，它们也难以有效地去除。
至于特效的处理方法，以前提出并使用的包括在异质肝部分上或越过与肝细胞接触的膜进行血灌注。还提出并使用的是通过涂覆了的活性炭柱或大网络树脂柱的血液灌注法、血交换法、以血浆置换的血浆除去法、通过能结合胆红素和芳族氨基酸的吸附剂的以血浆灌注的血浆除去法、标准血液透析法、带有氨基酸透析液和血浆交换的标准血液透析法、高渗透的血液透析法、用浸有活性炭的膜进行的透析法、连续血液过滤法、腹膜透析法、口服吸附剂和许多其它疗法。
上述各种处理方法中的一些方法，对于昏迷二期和三期在神经病学方面有些改进，并有助于肝在损害后的再生，但对于昏迷四期用呼吸器的患者而言，未见有多大临床上的好转。此外，这些各种各样的处理方法，每种都对患者产生有害的作用而抵消其益处。通常可参阅Ash,S.R.,Treatment of Acute Hepatic Failure With Encephalopathy:AReview,Int.J.of Artif.Organs,Vol.14,pp.191-195(1991)。
例如，虽然每天进行活性炭血液灌注，对于肝衰竭和昏迷的患者在神经病学方面和生理方面有所改进，参见Winchester,J.F.,Hemoperfusion,inReplacement of Renal Function by Dialysis(Maher,J.F.,ed.),Dordrecht:Kluwer Academic Publishers,pp.439-459,(1989)，然而血液灌注需要系统的抗凝固措施，并还会减少血中的凝血因子和血小板。此外，在血液灌注柱中所用的相对较大的吸附剂颗粒，其表面积有限(约为1000-10,000m2)。因而可利用的吸附剂表面积在几小时内就被饱和，对结合型化学毒物的清除能力迅速降低而必须换用新柱。
另外，活性炭血液灌注法的临床得益，可能被生物不配伍性的有害影响所抵消。在一个实例中，在对一些急性肝衰竭患者都进行深入细致护理，包括对大脑内压的监测的情况下，对照研究结果表明，用血液灌注法治疗的患者通常比仅采用深入细致护理的患者的存活率低。据报导，唯一的例外是对因A型肝炎或B型肝炎而引起的急性肝衰竭患者而言，采用活性炭灌注法治疗有提高存活的趋势。参见O’Grady,J.G.et al.,ControlledTrials of Charcoal Hemoperfusion and Prognostic Factors inFulminant Hepatic Failure,Gastroenterology,Vol.94,pp.1186-92(1988)。
如上所述，也曾研究将标准血液透析法(即只用透析液的血透析法)当作治疗肝衰竭的可能方法。然而，血液透析的得益可能因一些已知并不是肝衰竭毒素的物质(例如尿素)被除去而受到掩盖。此外，血液透析需用大量的透析液，这限制了透析设备的机动性并增加其复杂性，或需要配备吸附柱来“再生”该透析液。
根据上述背景情况可见，为了有效地去除毒素，包括可溶性毒素和与蛋白质结合的毒素，仍需有更好的用于体外处理血或血级分的装置和方法。本发明可以满足上述需要。
发明概述
本发明提供了一种独特的过滤方法(例如血液过滤法或血浆过滤法)，该法可高度有效地去除与蛋白质结合的毒素和中等分子量的毒素。本发明的方法包括以下步骤：将一种液体，例如含有与蛋白质结合的毒素或中等分子量血毒素的血，通过空心纤维膜的内部；以及在血通过之际，将吸附剂悬浮液紧贴着该空心纤维膜的外表面循环。另一个步骤是，在血通过和吸附剂悬浮液循环之际，使血中的血浆级分交替地离开和再进入该空心纤维膜的内部。由此，血浆在从该膜的内部离开之际即与吸附剂悬浮液接触，以实现从血中去除这些毒素。本发明的这一实施方案优选适用于全血；然而本发明并不局限于此，因为本发明也可以应用于处理其它含中等分子量毒素和/或与蛋白质结合的血毒素的液体，例如分离的血浆之类的血级分，或含有其它血毒素的液体，如血滤液之类。
本发明的另一个优选实施方案提供了一种装置，该装置可高度有效地从诸如血、血浆或血滤液之类的液体中去除与蛋白质结合的毒素或中等分子量毒素。本发明的这一优选的装置包括空心纤维膜和与该膜的内部灵活地(fluidly)相连的泵，该泵适用于将血(或其它含毒素的液体)通过该膜的内部。该装置还包括环绕着空心纤维膜的外室，该室还与含固体吸附剂微粒的吸附剂悬浮液供应源灵活地相连。用泵将此吸附剂悬浮液循环通过该外室而与该空心纤维膜外表面接触。还配备有可使在该膜内部流通的血或其它液体或它们的级分交替地离开和再进入此空心纤维膜内部的装置。
本发明的再一个优选实施方案提供了一种在体外处理血或血级分的装置中将吸附剂悬浮液循环的方法。本发明的这种方法包括在装置中配有以膜与膜间分开的吸附剂循环回路和血循环回路，该膜具有柔性，它能与交替施加于吸附剂循环回路的正压和负压相呼应而扩张和收缩，由此推动吸附剂悬浮液通过该吸附剂悬浮液循环回路。还配有一个蓄液罐，它与吸附剂循环回路灵活地相连，并能与交替施加于其上的负压和正压相呼应而将吸附剂悬浮液交替地蓄积和排出。由此，蓄液罐将这样交替的负压和正压传递给吸附剂循环回路。本方法还包括交替施加正压和负压于蓄液罐上，以致同样地将其传递给吸附剂循环回路并使上述柔性膜扩张和收缩，从而推动吸附剂悬浮液通过吸附剂悬浮液回路。
本发明的又一个优选实施方案提供了一种用于体外处理血或血级分的装置。该装置具有通过膜与膜间分开的吸附剂循环回路和血循环回路，其中的这些膜具有柔性，能与交替施加于吸附剂循环回路的正压和负压相呼应而扩张和收缩，由此推动吸附剂悬浮液通过吸附剂悬浮液循环回路。在吸附剂循环回路上灵活地连结有一个蓄液罐，该罐能与交替施加于其上的负压和正压相呼应而将吸附剂悬浮液交替地蓄积和排出，该罐从而可将交替的负压和正压传递给吸附剂循环回路。本装置还包括正压和负压源，它与蓄液罐灵活地相连。当交替的正压和负压交替地施加于蓄液罐上时，同样地将其传递给吸附剂循环回路而使上述柔性膜扩张和收缩，从而推动吸附剂悬浮液通过吸附剂悬浮液回路。
这样，本发明提供了可以实现从血、血浆或血滤液中显著地去除与蛋白质结合的血毒素和中等分子量血毒素的方法和装置，借此还可在许多不同类型体外处理装置的吸附剂一侧实现吸附剂的有效循环。本发明另外的目的、特征和优点，可从以下的阐述明显看出。
附图简述
图1是可用于本发明的优选压缩空气/真空操作透析系统的透视图。
图2是图1透析系统中液流系统的示意图。
图3是在血流入的初始期间(图3A)和血流入的其余期间以及血流出的期间(图3B)，图1优选的直接压缩空气/真空操作透析系统的操作结构示意图。
图4是将图1系统与空心纤维血浆过滤器串连在一起的联合装置的液流回路示意图。
图5(a)所示为图4联合装置中图1系统与血浆过滤器之间血的一侧，在几次流入-流出循环期间的压力曲线。
图5(b)所示为图4联合装置的血浆过滤膜组件中吸附剂一侧的压力曲线。血-吸附剂平均压差近似为零。
图6(a)所示为活性炭从首先与磺溴酞钠(BSP)结合的盐水(上部曲线)和猪血浆(下部曲线)中结合此BSP的朗格缪尔等温线。
图6(b)所示为活性炭从首先与非结合型胆红素结合的猪血浆中结合此胆红素的朗格缪尔等温线。
优选实施方案的描述
为了促进对本发明原理的理解，将提及某些实施方案，并将专门加以描述。然而，应认为绝不因此而限制本发明所涉及的范围，对于与本发明有关领域的技术人员而言，通常总是会企图对本文所述的本发明原理作一些变换、进一步修改和应用。
如上所述，本发明的一种优选实施方案涉及可安全、有效且始终如一地去除毒素的方法，所述毒素包括与蛋白质结合的血毒素和中等分子量血毒素，该方法可用于血或血级分的体外过滤处理，例如血浆过滤(其中血浆穿过滤膜)或血液过滤(其中分子量约300至约10,000的中等分子量分子穿过滤膜)。本过滤法可单独使用，或者与血或血级分的透析法连用，例如用我以前在1992年2月6日提交的美国专利申请(其申请序列号为07/832,080)所述的透析装置和方法，现特将其作为一个整体引入本文作为参考。同样地，以前的这项发明所述的有利的吸附剂循环系统和方法，对推动吸附剂悬浮液通过空心纤维血浆过滤器和血液过滤器而言，也是有效的，并可广泛应用来推动吸附剂悬浮液通过各种以膜将血和吸附剂两侧分开的体外处理装置，因此这种吸附剂循环系统和方法也成为本申请人发明的一部分。
本发明所用的吸附剂悬浮液可包括粉状表面吸附剂、生理电解质和大分子流动诱导剂。一般都存在有效量的这些组分，使得从患者的血中去除毒物能达到所需程度，并使患者的血能达到电解质平衡，同时还能保持该吸附剂悬浮液的稳定性和流动性。因为用于本发明的血浆过滤膜有可能使内毒素透过，所以优选的吸附剂悬浮液应不合可测出的内毒素。通常的吸附剂悬浮液配制技术已能满足这些要求，如果必要，还可采取措施对悬浮液进行消毒或灭菌，例如用加热或辐射(如γ-辐射)，以保证该悬浮液基本上没有细菌或其它可能产生内毒素或别的有害物质的微生物滋长。
粉状表面吸附剂可以是许多已知用于本领域的吸附剂中的任一种，但优选的是粉状活性炭。再者，优选的粉状表面吸附剂，其平均粒径应不大于约100微米。更优选的是，其平均粒径应小于约50微米，而且其中90％或以上的微粒粒径应不大于约75微米。如果必要，可将粒径超过75微米的微粒筛除。例如，American Norit Company,Inc.of Jacksonville,Florida,U.S.A.，可提供适宜的细粉状活性炭，并可将那些大于所需粒径的微粒筛除。
大分子流动诱导剂的作用是保持配成的吸附剂悬浮液的稳定性(即帮助防止固体从悬浮液中沉下来)和保持该悬浮液的流动性。合乎需要的流动诱导剂之一是非离子型的含羟基聚合物，例如乙二醇衍生物。BASFWyandotte of Parsippany,New Jersey,U.S.A.，可提供适宜的这类药剂，其商标为“Pluronic”多元醇。这些Pluronic多元醇是丙二醇的聚氧化烯衍生物。至今为止，本申请人已采用Pluronic F68来作为流动诱导剂和消泡剂。另一已包含在优选的悬浮液中的流动剂是大网状的聚乙烯吡咯烷酮。
在配成的悬浮液中所含的电解质类型和数量根据患者的具体需要而定，通过内科医生或其他本领域的技术人员很容易确定。这些电解质通常包括钠和氯离子(例如任选由氯化钠提供)，还包括碳酸氢根、钾、钙或任何其它的患者有待调节的电解质。然而，如上所述，电解质的类型和数量可能随患者需要而有很大改变。
配成的吸附剂悬浮液还可以包括离子交换剂以结合患者血中可能存在的离子型化学物质，例如铵离子等。许多适宜的离子交换剂，包括树脂类和其它材料例如沸石，在本领域都是已知的。当包括离子交换剂时，优选采用钠型或钙型阳离子交换树脂。例如，至今聚苯乙烯磺酸钠是一种优选的材料。
表面吸附剂、电解质、流动诱导剂和任何其它添加剂通常约占配成的吸附剂悬浮液总量的5％至30％(重量)，其余部分为水。通常，固体吸附剂约占悬浮液配方总量的2％至25％(重量)，电解质约占悬浮液配方总量的1％至5％(重量)。在这些参数中，更优选配成的吸附剂悬浮液包括约2％至20％的粉状表面吸附剂、至多约10％的离子交换剂和至多约1％的流动剂，例如多元醇和/或聚乙烯吡咯烷酮。
吸附剂悬浮液还可包括活的肝细胞，例如异种的或异发的细胞，单独使用或与上述的一种或多种固体吸附剂和其它材料合用，以有助于有效去除毒素。例如，按Dixit等人所述，参见Hepatology 1990:12:1342，可将肝细胞从适宜的给体组织中分出，加以纯化和装于微囊中。然后这些装在微囊中的细胞可直接用在吸附剂悬浮液中或冷冻贮藏直至使用，例如按Dixit等人所述的方法进行，参见Transplantation 1993；55:616-22。当如此使用肝细胞时，血浆透过血浆过滤器的膜而有效地从血中分出，蛋白质和毒素则借对流与膜外循环的肝细胞接触。在这些肝细胞对毒素起作用后，血浆再通过该膜返回并流回患者体内。
关于血浆过滤或血液过滤的装置和方法，已知有许多种适用于血的血浆过滤或血液过滤的空心纤维膜，本领域的技术人员能很容易地选用适合本发明的膜。例如这种膜可以是纤维质膜(例如乙酸纤维素)，其孔尺寸应大到足以使血浆蛋白质透过(例如血浆过滤时)和/或使中等分子量血毒素透过(例如血液过滤时)，适宜的截止分子量约为50,000或以上，例如50,000至6,000,000。适宜的血浆过滤和血液过滤膜包括，例如，下述的几种牌号：F-80(截止分子量50,000,Fresenius USA,Inc.,WalnutCreek,CA)；Altrex 140(截止分子量70,000,Althin Medical,Inc.,MiamiLakes,FL)；CT190G(截止分子量60,000,Baxter,Deerfield,IL)；和Plasmaflo AP-05H(L)(截止分子量约1,000,000,Asahi MedicalCo.,Ltd.,Tokyo,Japan)。更优选的血浆过滤膜，其孔尺寸应能以高于对较大分子的选择性透过白蛋白或中等分子量的分子，因此可在尽量减小对其它血功能的影响的同时，实现毒素的去除。例如，Plasmaflow AP-05H(L)的血浆分离器(0.5平方米)在单向过滤时白蛋白的拒斥率约为5％，但巨球蛋白的拒斥率约为80％。
关于本发明使用的透析法，已知有许多用于透析体液例如血的透析器膜，本领域的技术人员可很容易地选用适合本发明的膜。有一种适宜的膜是纤维质膜，特别是由再生的铜铵纤维素组成的膜(铜纺(Cuprophan))。
在只需要血或其它液体的血浆过滤或血液过滤(不需要透析)时，透析器中的膜不需要用透析膜，因此可用一种不透血及其组分的膜，例如由适宜的柔性塑料膜制成的膜。再者，当只需要血浆过滤或血液过滤时，完全不需要用透析器，任何将吸附剂悬浮液循环接触空心纤维膜外面，同时将血或其它流体通过该膜的内部(并能使血或流体双向透过该膜)的方法都将是适宜的。例如，空心纤维膜外筒的吸附剂悬浮液接口可与一装满吸附剂悬浮液的容器相连。当利用，例如，滚柱泵将吸附剂悬浮液循环通过该外筒时，血一侧的压力变化(由滚柱泵自动引起的)可引起所需的血浆或其它液体双向透过该膜。这种系统既非常简单又价格低廉，对与蛋白质结合的毒素或中等分子量毒素能有高的清除效果。
本发明创造性的血浆过滤或血液过滤方法在与优选的透析系统联用时，包括用平行板透析器和通过直接对透析液一侧交替施加负压和正压来使吸附剂悬浮液作逆液运动是有利的。下列实施例1和实施例2中有详细描述。该优选系统还可使配成的吸附剂悬浮液产生轻微的前后运动，这可起到搅拌、局部混合和有助于避免悬浮液沉降的作用。
本发明体外处理血的方法可用来安全而有效地治疗昏迷和肝衰竭病，并改善患者生理方面和神经病学方面的临床状况。本发明的方法还可成功地用于医治过量服药，即使是能与蛋白质高度结合的药物(即有75％或以上能与蛋白质结合的药物)。可以预期的是，本发明的方法和装置还可有效地治疗肾衰竭、尿毒症或其它症状，经去除血中毒素后能有益处的患者。再者，本发明的血浆过滤和/或透析方法可用于血液过滤以处理和除去血液过滤的超滤液中的毒素。以这种方式可将使用大量无菌置换液的局面改善或消除。
现将参照以下的一些具体实施例详细说明本发明，这些实施例是说明性的，对本发明绝无限制。
实施例1
优选真空/压缩空气操作流通式透析系统的
操作和其组成部分
图1是放在标准医院手推车上的优选透析系统11的透视图，该系统可在本发明的方法中使用。一般说来，优选透析系统11在一些方面与我以前的1987年4月28日颁发的美国专利4,661,246中公开的透析器相似，现特将其作为一个整体引入本文作为参考。然而，为了使透析器充满血和排空血，本系统采取直接应用压缩空气和真空来产生透析液的正压和负压的变化。这增加血的流动、提高配成的吸附剂悬浮液的混合强度，并有助于保持穿过透析膜的最佳化学物质浓度梯度。
继续参见图1，透析系统11包括底座12、贮液槽13、贮槽盖14、装有吸附剂悬浮液物料的吸附剂袋15、一次性的组件16(包括平板透析器)和动力源17(提供真空、压缩空气和直流电源至底座。现再参见图2和图3，图2是该透析系统的液流示意图；图3分成部分A和部分B分别概述该系统在血流入和血流出期间操作的结构和液流状态。一般说来，在下述的讨论中，编号20至47将用来标示一次性的组件16上的各组成部分，而编号50和以上将标示底座12上的各组成部分。在图1中，底座12和一次性的组件16是分开表示的。当然，使用时是在一起的，组件16安放在底座12上，它们的各组成部分一般按如下方式装配。
将真空/压缩空气管线20从蓄液罐22顶部接口21连至底座12上的真空/压缩空气接口50，它从动力源17中相应的真空源和压缩空气源提供真空和压缩空气。将起动液管23放入起动/冲洗夹51的上部并通过起动液传感器52。将血流入管24放入起动冲洗夹51的下部、血流入夹53和血流入传感器54中。将血流出管25放入血流出夹55和血流出传感器56中，并将液面传感器57放在蓄液罐22上。将再输注液管26装入再输注液泵58和再输注液传感器59中。将透析液管27(“Y”岔管以前的部分)装在透析液泵60中，并将该管的端部连在水接口61上。将与透析器30上的透析液进口29相连的透析液支管28(“Y”岔管以后的部分)放入透析液流入夹62中。将滤液管线31装入滤液泵63和滤液传感器64中。滤液管线31还与有排气孔的滤液处置袋32相连。将3升无菌水加入贮液槽13中。再将吸附剂袋15从贮液槽盖14悬挂下来。将管33(通至透析液进口29)和管34(通至蓄液罐22的出口，并经管线36与透析液出口35相连)与装在吸附剂袋15上并引入其中的管线37和管线38相连。
下述各步骤都是在无菌条件下进行的。将血流入管线24和血流出管线25分别与透析器30上的血进口39和血出口40相连。将再输注液(例如CaCl2溶液和适量的KCl和/或NaCl溶液)注入再输注液袋41中。将再输注液管线26与再输注液袋41相连，并将该管线上的滴注器部分充满。将起动液管23与装有起动液，例如5％葡萄糖的起动液瓶42相连。如果需要，可经过液体置换管线43提供置换液。
这样，在完成上述组装工作后，从单路进血管线44来的血流入管24和血流出管25，经过夹子53和55以及光学检测器54和56而与透析器30的血一侧的顶部开孔39和底部开孔40相连。园筒形蓄液罐22与透析器30的透析液一侧的顶部开孔35处的透析液相接触，而蓄液罐22中交替的强烈真空(即负压)和适中的正压(由管线20经该蓄液罐液面上的接口21提供)将透析液交替地引入和排出蓄液罐，并使透析器30的膜经受扩张和压缩(如图5中以箭头所示)，这时自动控制的血流入夹53和血流出夹55保证血单方向流过透析器30，其平均流速至多为250ml/min(5个循环平均)。流入/流出循环的时间比决定其超滤速度，从时间比约为1.45的最小超滤速度约200ml/hr至时间比约为2.45的超滤速度约600ml/hr。
在本实施例使用的优选透析系统11中，透析器是1.6m2COBE平行筛板式透析器，其透析膜是由再生的铜铵纤维素组成的膜(铜纺)，该膜的截止功能分子量约3000道尔顿，即只有约3000道尔顿或更低的分子可透过该膜。
与许多以前所知的透析系统相反，用在本发明中的这种系统，其透析液中含有吸附剂悬浮体而不是仅为一种透析溶液。该悬浮液一般是逆流流动，且在蓄液罐22和透析器30之间作双向流动，而且在透析器30和吸附剂袋15之间作循环流动。
总起来说，在血流入的初始期间(详见图3A)，透析液流入管线33上的夹子62打开，使吸附剂悬浮液从吸附剂袋15流过整个透析器30，并注入蓄液罐22直至其中液面到达传感器57。然后夹子62关闭，而且在血流入的其余期间和全部血流出期间(详见图3B)，该夹子一直保持关闭状态，当蓄液罐22中为正压时，使一部分悬浮液返回至透析器30，并使另一部分经过单向阀45沿透析液返回管线34返回至吸附剂袋15。在典型操作中，每分钟约有900ml吸附剂悬浮液流入蓄液罐22(5个循环平均)。其中600ml吸附剂悬浮液流回至透析器30中，300ml从蓄液罐22流至吸附剂袋15。这与透析器膜的扩张和收缩一起使吸附剂悬浮液在透析器膜的表面处充分地混合。典型的血一侧和透析液一侧的压力，以及该透析器在如此操作期间的血体积情况示于图4。可以看出，血一侧和透析液一侧的压力都是时而正压，时而负压，与此同时平板透析器膜的弹性作用保证从血一侧向透析液一侧持续地存在有正压梯度。
在一个适宜的系统中，吸附剂袋15起初装有干的吸附剂材料，在该系统起动期间，1.5升无菌水自动地从贮液槽13经接口61加至吸附剂袋15中。这一操作是由透析液泵60驱动的。对下述实施例而言，吸附剂袋15中的吸附剂材料包括如下组分：
140克粉状活性炭(300,000平方米表面积，平均粒径5微米至53微米，最大粒径70微米)；
80克阳离子交换剂(聚苯乙烯磺酸钠，PSS,80mEq交换容量(functional binding))；
1.5克Pluronic F68；
3.0克聚乙烯吡啶烷酮；
碳酸氢钠和氯化钠，其量为在该系统起动后含吸附剂悬浮体的透析液中应达到生理起始浓度(钠为140mEq/L，碳酸氢根为35mEq/L，氯根为105mEq/L)。
用于该透析系统血一侧的起动液是1升5％的葡萄糖溶液，它来自经管23与血流入管24相接的容器42。在起动期间，起动/冲洗夹自动打开起动液管23，同时关闭血流入管24。这样，不是将血而是将起动液抽入该系统中。这时葡萄糖透过透析器30的膜，有20克葡萄糖与透析液中的活性炭相结合，与此同时氯化钠和碳酸氢钠则从该悬浮液移至起动液中。在透析期间，葡萄糖从活性炭上离解而返回至患者(除非患者的葡萄糖量太高)。在整个治疗过程中，用再输注液泵58将无菌氯化钙和氯化钾再输注液从容器41经管26以缓慢速度送至血流出管线25中，以补偿被阳离子交换剂除去的量。
为使操作安全、简单和高度自动化，该系统还装有各种传感器，这包括：
一台磅秤，这是用来秤得整个装置的最高总重(entire top)，从而计量从患者超滤出的和返回至患者的液体体积；
血传感器(54和56)，这是用来检测血流入管24和血流出管25中血的泡沫、气泡和微粒，并检测血流入管24中的流速；
血红蛋白传感器46，用于化学法检验吸附剂悬浮液中的血红蛋白，如果有膜出现血漏泄的话；为此，滤液收集器47将无固体的透析液试样提供给血红蛋白灵敏试带，如有血红蛋白存在，则该试带会变色；该试带自动地受到透析液试样的润湿、向前移动再受到反射计监测其颜色变化；该试带的润湿由滤液泵63控制，该泵还将多余的滤液经过管31送至收集容器32中；
装在所有充满液体的各管线上的空管传感器；
环绕着吸附剂袋15的贮液槽13中液体的温度传感器(最好用配在装置中的加热元件加热至约37°至40℃)。
该系统的计算机使许多处理步骤自动化，这包括：
装置的起动，观察各管线，确认其中所有空气都已除去；
当达到所需的最终装置重量时或根据指令(这时自动调节超滤过程来达到所需的最终装置重量)，将液体返回至患者；
在治疗结束时冲洗透析器和血管线；和
记录、储存和传递有关每次治疗进展的数据。
实施例2
透析/血浆过滤或血液过滤联合装置
图4给出了按照本发明的透析/血浆过滤联合装置的液流示意图。如图所示，该装置将平行板透析器(“PPD”)与空心纤维膜组件(“HFD”)串连在一起。关于这一点，应该认为本发明并不局限于这种联合装置，而HFD可以单独使用来处理血。再者，当与PPD联合使用时，HFD可以在PPD的吸附剂循环一侧的任何适宜位置处相连。优选的是，HFD应如此连接，使得血浆达到高速地双向透过HFD的膜，而其净流量约为零以避免增加吸附剂的体积(这将增加白蛋白分布的体积，并增加患者白蛋白的损失)。该HFD还需要如此连接，使得血处理速度大于150ml/min，并使与蛋白质结合的物质或中等分子量物质有高的透过该膜的过滤速度和得到高的清除效果。
在图4中，HFD与PPD如此串连起来，使离开吸附剂袋的吸附剂悬浮液先通过PPD，再通过HFD。更具体而言，吸附剂首先从吸附剂袋101中抽出，进入PPD的吸附剂进口102。吸附剂离开吸附剂出口103而抽至蓄液罐104中，之后，将吸附剂从蓄液罐104中排出并通过单向阀105。然后该吸附剂悬浮液流入HFD入口106并通过HFD的外室，这样即与HFD中的空心纤维107的外表面相接触。吸附剂悬浮液从出口108离开该HFD，再流过血漏泄检测器109后，返回至吸附剂袋101中。PPD可按以上实施例1中所述的方式来适宜地操作。这样，在HFD中膜的表面处吸附剂悬浮液也能得到有效的搅拌和混合。此外，当交替的正压和负压通过蓄液罐104施加于吸附剂回路时，单向阀105可阻止负压施加于HFD的吸附剂一侧而仅形成周期性的正压(图5(b))。在该系统中，血一侧的(见图5(a))和透析液一侧的压力随每一循环而变化，但平均起来是平衡的，这样在第一循环中即形成一双向流动而使其净过滤量为零(在HFD中有净的吸附剂一侧至血一侧的过滤量以抵消PPD的超滤量，约几百ml/hr。)。
在血一侧，血从患者进血管线流至PPD的血入口110内，其间从受器111添加盐水。在PPD中装有透析膜(与不透性膜相反)的情况下，血如以上所述那样在该PPD中得到透析。然后血经出口112离开PPD而流入HFD的空心纤维的内部通道中(HFD组件商品是一种装有许多空心纤维膜的组件)。这时施加于吸附剂一侧的交替的正压和负压使血浆双向透过这些空心纤维膜，即血浆离开然后再进入这些空心纤维膜。当在血液过滤或血浆过滤膜的外部时，中等分子量毒素和/或血浆蛋白质，包括结合有毒物的蛋白质，即与吸附剂悬浮液接触。这些毒物被吸附剂吸附，在血浆过滤时，这些已除去毒素的蛋白质又返回至空心纤维膜内部。这样，在血通过该HFD时，它可得到有效的血浆过滤或血液过滤。血经过出口113离开HFD，再通过患者进血管线返回至患者。
血一侧和吸附剂一侧的压力随所用的特定HFD组件的不同而异。因此，对一特定的HFD组件而言，可进行体外试验测定其过滤速度，调节用来操作该系统的真空和压缩空气以达到零净过滤量。再者，为了优化血流动情况，可对流入/流出时间比进行调节。如同实施例1所述的系统，这种PPD/HFD联合系统可用将整个装置，包括吸附剂袋在内，秤量最高总重的方法来计量超滤速度。但是，由于目标是净超滤量约为零，所以不需要实施例1系统那样的长流入时间。采用大约相等的流入和流出时间，可得到更好的血流动情况。在进行体外试验(例如用猪血)期间，驱动压力可按上述方法调节，然后测定净血流速(通过观察每一循环期间3升容器的重量变化的情况)。然后调节流入-流出时间，以达到最大血流速。优选的是，将实施例1系统的平均血流速保持为200-225ml/min。
实施例3
用透析/血浆过滤或血液过滤装置处理血
活性炭具有非常有效地吸附中等分子量分子和与蛋白质结合的毒素的能力(例如，参见图6(a)和图6(b)提供的从血浆和盐水中吸附BSP的朗格缪尔等温线和从血浆中吸附胆红素的朗格缪尔等温线)。在下述研究中，采用实施例2所述的PPD/HFD装置来测定从血中清除一些与蛋白质结合的物质和中等分子量物质的效率。在3升新鲜猪血中掺入不同物质(列于下述表1中)，再将该血用PPD/HFD装置处理。在数小时的处理期间，将该血与这些物质以预定的速度连续输注以保持一恒定浓度(由预计的该系统的清除效率来计算的)。然后用掺入物质的稳态浓度除输注速度求得清除效率。如果血体积变化，则将这种变化包括在清除效率的计算中。结果列于表1中，表中“Creat”=肌酸酐，“Bili”=胆红素，“BSP”=磺溴酞钠和“Vanco”=万古霉素。其中，肌酸酐是小分子量的非与蛋白质结合的物质，胆红素、盐酸阿米替林和SBP是小的与蛋白质高度结合的分子，而万古霉素是中等分子量的非与蛋白质结合的物质。
表1
血流速和清除效率(ml/min)
Ave膜 Ob． 肌酸酐 胆红素 磺溴酞钠 盐酸阿米替林 万古霉素只用PPD 200 140 0 0 12 0F-80 150 130 12 n/a 40 -Altrex140 180 130 5 n/a - -(70K)Althin* 140 90 5 n/a 19 37CT190G 160 85 0 - - 62Plasmaflo 140 95 43 n/a n/a 35AP-05H(L)-(短划)=无数据n/a=目前尚未取得数据*Althin Medical,Inc.开发的过滤膜，截止分子量=100,000。
可以看出，使用HFD可明显提高对中等分子量的物质和与蛋白质结合的物质的清除效率；在与PPD联用时可对小分子和较大分子的，与蛋白质结合的或非与蛋白质结合的物质进行有效的总清除。
尽管已用图和前面的描述来对本发明作了详细阐述，但仍应看作是说明性的而绝非是限制性的，应该理解所列出和描述的只是优选的实施方案，所有来自本发明的精神范围的改变和改进都要求加以保护。
Claims (10)
1．一种去除血毒素的过滤方法，该方法包括：
将含有与蛋白质结合的血毒素和/或中等分子量血毒素的液体通过空心纤维膜的内部；
在该液体通过之际，将吸附剂悬浮液紧贴着该空心纤维膜的外表面循环；
在该液体通过和吸附剂悬浮液循环之际，将周期性的正压脉冲施加于该吸附剂悬浮液，使该液体或其级分交替地离开和再进入该空心纤维膜的内部，其中所述离开空心纤维膜内部的液体或级分含有与蛋白质结合的毒素和/或中等分子量的毒素，它与所述的吸附剂悬浮液接触以实现从该液体中去除这些毒素，并将所述毒素传递给所述吸附剂悬浮液中。
2．权利要求1的方法，其中所述的空心纤维膜是一种血液过滤膜，可借以将中等分子量毒素从该液体中去除。
3．权利要求1的方法，其中所述的空心纤维膜是一种血浆过滤膜，可借以将中等分子量毒素和与蛋白质结合的毒素从该液体中去除。
4．权利要求1的方法，其中所述的液体是血。
5．权利要求3的方法，其中所述的血浆过滤膜能以高于对较大蛋白质的选择性透过白蛋白。
6．一种血透析装置，该装置包括：
一种空心纤维膜；
一种与该空心纤维膜内部灵活地相连的泵，该泵适用于将含有中等分子量的血毒素和/或与蛋白质结合的血毒素的液体通过该空心纤维膜内部；
一个环绕着该空心纤维膜的外室，该室还与吸附剂悬浮液供应源灵活地相连；
一种适用于将所述吸附剂悬浮液循环通过所述外室，而与该空心纤维膜外表面接触的泵；和
用来使在该空心纤维膜内部流过的所述液体或其级分交替地离开和再进入该膜内的装置。
7．权利要求6的装置，其中所述的空心纤维膜是一种血液过滤膜。
8．权利要求6的装置，其中所述的空心纤维膜是一种血浆过滤膜。
9．权利要求8的装置，其中所述的血浆过滤膜能以高于对较大蛋白质的选择性透过白蛋白。
10．权利要求6的装置，该装置还包括一种与该空心纤维膜内部灵活地串连的适用于透析所述液体的透析器。
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| US08/180,080 | 1994-01-11 | ||
| US08/180,080 US5536412A (en) | 1992-02-06 | 1994-01-11 | Hemofiltration and plasmafiltration devices and methods |
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- 1995-01-11 BR BR9506474A patent/BR9506474A/pt not_active Application Discontinuation
- 1995-01-11 JP JP7518691A patent/JPH09507414A/ja not_active Ceased
- 1995-01-11 AU AU16782/95A patent/AU1678295A/en not_active Abandoned
- 1995-01-11 DE DE69531192T patent/DE69531192D1/de not_active Expired - Lifetime
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Also Published As
| Publication number | Publication date |
|---|---|
| CA2180455A1 (en) | 1995-07-13 |
| KR100367186B1 (ko) | 2003-02-26 |
| BR9506474A (pt) | 1997-10-07 |
| EP0739234B1 (en) | 2003-07-02 |
| EP0739234A4 (en) | 1999-03-03 |
| CN1143334A (zh) | 1997-02-19 |
| WO1995018671A1 (en) | 1995-07-13 |
| EP0739234A1 (en) | 1996-10-30 |
| JPH09507414A (ja) | 1997-07-29 |
| DE69531192D1 (de) | 2003-08-07 |
| AU1678295A (en) | 1995-08-01 |
| US5536412A (en) | 1996-07-16 |
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