CN103957960A - 用于透析系统的热交换流体净化 - Google Patents
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Abstract
在此披露了小型的、重量轻的、便携式的系统,其具有可靠地、可再现地、高效地且相对便宜地提供用于家用透析的足够量净化水的来源的能力。另外,在此披露的系统在任何一次所需的净化水比现今透析通常所需的量少得多,由此进一步降低了在家运行系统的费用。
Description
相关申请的参考
本申请要求2011年10月7日申请的、名称为“Heat Exchange FluidPurification For Dialysis System”的序列号为61/545084的美国临时专利申请的优先权的权益。在此要求上述申请日的优先权并且通过引用将上述专利申请的公开内容全部并入本文中。
本申请与下列美国专利申请相关:(1)2010年6月7日申请的、名称为“Microfluidic Devices”的序列号为12/795371的美国专利申请,其要求2009年6月24日申请的、序列号为61/220117的美国临时专利申请的优先权;(2)2010年6月7日申请的、名称为“Dialysis System WithUltrafiltration Control”的序列号为12/795498的美国专利申请,其要求2009年12月5日申请的、序列号为61/267043的美国临时专利申请的优先权;(3)2010年6月7日申请的、名称为“Fluid Purification System”的序列号为12/795382的美国专利申请;(4)2010年6月7日申请的、名称为“Dialysis System”的序列号为12/795444的美国专利申请。本申请还与2010年6月7日申请的、名称为“Microfluidic Devices”的国际专利申请PCT/US2010/037621相关。通过引用将上述专利申请的公开内容全部并入本文中。
技术领域
本公开内容涉及透析系统,例如能流体地结合到透析液流和血流的微流体或流场透析器,和使用透析系统的方法。
背景技术
目前,在美国有成百上千的患者有晚期肾病。他们中的大部分都需要透析以便继续存活。美国肾脏数据系统预测透析的美国患者数量在2012年将超过600000。许多患者在透析中心接受透析治疗,其能将苛求的、限制性的和麻烦的时间表强加给患者。接受中心里的透析的患者通常必须一星期去中心至少三次并且每次坐在椅子上3至4小时,同时毒素和过量的流体被从他们的血液中滤除。治疗之后,患者必须等待打针点停止流血并使血压回复正常,这需要从他们日常生活中其他更充实的活动中占据更多的时间。此外,中心里的患者必须遵循不可协调的时间表,因为典型的中心在一天的过程中治疗三至五轮患者。结果,许多一星期透析三次的人抱怨在一次治疗后感到疲惫至少几个小时。
鉴于中心里透析的苛刻特性,许多患者把在家透析作为一种选择。在家透析提供给患者日程安排的灵活性,因为它允许患者选择治疗时间以适应其他活动,例如去上班或照顾家庭成员。不幸地,目前的透析系统一般不适合在患者的家里使用。其中一个理由是目前的系统太大和沉重以致不能安装在典型的住宅内。目前的透析系统也是能源效率低的,因为它们使用大量的能量并且需要巨量的水以便正确使用。虽然一些家用透析系统是可用的,但它们一般使用制造相对比较昂贵的复杂的流动平衡技术,并且大部分系统设计成具有会引起高噪声水平的电磁阀的系统。因此,大部分透析治疗在透析中心进行。
发明内容
鉴于上述情况,需要改进的流体净化系统,特别是水净化系统,用于准备和家用透析一道使用的流体。
在一个方面中,公开了一种水处理设备,其包括以堆叠关系布置以便形成薄片堆的至少第一薄片和第二薄片,每个薄片具有流体流场,第一薄片的流体流场配置成用于接收血液,第二薄片的流体流场配置成用于接收透析液;第一薄片中的第一切口,其中第一切口包围第一薄片的流体流场的至少一部分;第二薄片上的第二切口,其中第二切口包围第二薄片的流体流场的至少一部分,并且其中第一切口和第二切口在所述堆中垂直地彼此对齐以形成贯穿所述堆的集合切口;和在所述堆的顶部上的第一板和在所述堆的底部上的第二板,其中第一板和第二板封闭集合切口的顶部和底部,形成对所述堆的流体流场的绝热室。
每个切口可以沿着流场的至少三侧包围各自的流场,每个切口包围各自流场的至少百分之八十。所述堆可以包括两个以上的薄片。集合切口可以形成环绕所述堆的流体流场的U形。设备还可以包括插入第一流场和第二流场之间的至少一个热传递层,当在操作中时,血液的透析横穿该热传递层发生。绝热通路可以抑制从流场的一个或多个区域的热损失。在绝热室内可以形成部分真空,薄片的流体流场可以具有盘绕配置并且被盘绕的绝热室包围。
根据下面的不同实施方式的描述,其他特征和优点将是显而易见的,所述实施方式作为例子阐明了被披露的设备和方法的原理。
附图说明
图1表示透析系统的实施的高层次示意图;
图2表示透析系统的水净化系统的实施的高层次示意图;
图3表示微流体热交换系统的实施的示意性平面图,其适合于在不使用第二流体流给流体增加热量或从流体移除热量的情况下加热和冷却单个流体;
图4表示透析系统的透析液制备系统的实施的高层次示意图;
图5表示透析系统的透析器的实施的示意性横截面图;
图6表示流动平衡系统的实施的示意图;
图7A表示形成至少一个入口路径的入口薄片的示例性实施方式,在入口路径,流体沿向内方向流动通过热交换系统;
图7B表示形成至少一个出口路径的出口薄片的示例性实施方式,在出口路径,流体沿向外方向流动通过热交换系统;
图7C表示具有重叠的入口和出口薄片的示例性实施方式;
图8表示入口薄片的加热器区域的放大图;
图9表示薄片的示例性的堆805的透视图;
图10表示具有绝热结构的重叠薄片堆的另一个实施方式的平面图;
图11表示具有一对热交换区域的薄片的实施方式;
图12表示薄片的一实施方式,其具有环绕热交换区域的盘绕的流体流动路径。
具体实施方式
在此披露了小型的、重量轻的、便携式的系统,其具有可靠地、可再现地、高效地且相对便宜地提供用于家用透析的足够量净化水的来源的能力。另外,在此披露的系统在任何一次所需的净化水比现今透析通常所需的量少得多,由此进一步降低了在家运行系统的费用。另外,在此描述的系统能生产实时的、按需的用于透析的超纯水,能达到当今透析的黄金标准。在此披露了嵌入的、非批量的水净化系统,其用微流体热交换器来加热、净化和冷却水。在此描述的系统消耗比较少量的能量。在此描述的系统虽然适合于在家用透析系统中使用,但也可用于需要水净化的其他环境中。系统也可用来净化除水之外的流体。如下面更详细描述的,在此描述的系统可以连接到住宅的水源(例如提供连续的或半连续的家庭水流的自来水龙头)并能生产实时的巴氏杀菌水以在家用透析中使用,而不需要加热和冷却大量的、批量的水。
透析系统
图1表示透析系统的实施的高层次示意图。透析系统可以包括多个子系统,其共同操作以接收和净化水,用水制备透析液,并将透析液供应给透析器,透析器对患者的血液进行各种类型的透析,例如血液透析、超滤和血液透析滤过。透析系统可以包括管道系统,其为水、透析液和血液提供流体路径以流过透析系统,透析系统还包括与管道系统相连接以驱动流体流通过系统的一个或多个泵。透析系统还可以包括一个或多个传感器,例如流体流量传感器、压力传感器、电导率传感器等等,用于感测和报告流过系统的流体的一个或多个特性。
在一实施方式中,整个透析系统(包括水制备和净化系统、透析液制备系统、流动平衡器系统、透析器和硬件,例如管道系统和传感器)包含在紧凑且便携的单个外壳中。另外,透析系统可以利用例如家里的或旅馆房间里的自来水制备透析液。在一实施方式中,整个透析系统在干燥时消耗的空间小于大约22"乘14"乘9",这大体上对应于航空公司的随身行李的尺寸限制。在一实施方式中,在干燥时整个透析系统的重量小于大约五十磅。
仍然参考图1,透析系统可以包括水制备和净化系统5,其净化来自供水系统7的水。水净化系统5可以将净化水供应给透析液制备系统10,其用净化水制备透析液。透析系统还可以包括透析器15,其接收来自透析液制备系统10的透析液并对患者血液进行透析。在一实施方式中,透析器15和透析液制备系统10都可以与流动平衡器系统20相连接,该流动平衡器系统20调节透析液向透析器的流动以实现不同类型的透析,包括血液透析、超滤和血液透析滤过,如下面详细描述的。
扩散是主要机制,其中血液透析从血液中移除废产物,尤其例如尿素、肌酸酐、磷酸盐和尿酸。透析液的化学成分和透析器内血液的化学成分之间的差别使废产物通过膜从血液扩散到透析液中。超滤是透析中的过程,其中使流体穿过膜从血液移动到透析液中,典型地为了从患者的血流中移除过量的流体。连同水一起,一些溶质也通过对流而非扩散被抽过膜。超滤是血液腔和透析器中的透析液腔之间的压力差的结果,其中流体从较高压力向较低压力移动。在某些环境中,通过设计或无意的结果,透析液腔中的流体高于血液腔,使得流体从透析液腔移动到血液腔中。这一般被称为逆超滤。
在血液透析滤过中,为了增大穿过膜的对流溶质转移,产生高层次的超滤,大于从患者血液中移除流体所需的量。因而,超过从患者血液中被移除所需的量的流体量必须返回到血流中以便避免不利的血液动力学反应。这通过故意增大透析器的透析液腔中的压力以引起合适的逆超滤量来完成。与逆超滤交替的这个超滤过程通常被称为“推拉式血液透析滤过”。这是超越较普通的血液透析滤过方法的显著改进,在较普通的血液透析滤过方法中,无菌流体在透析器之外的位置中被给予患者。
在使用中,将患者与透析器15相连从而利用本领域技术人员已知的设备和技术使患者的血液流入和流出透析器15。透析系统利用来自家庭水源(例如水龙头)的水制备透析液,该水在与各种透析液成分混合以制造透析液之前已经预先通过过滤和净化准备好,然后使透析液流过与血液连通的透析器以便对血液进行一种或多种透析处理。水净化系统包括多个子系统,其共同操作以净化水,包括水的巴氏杀菌,如下面更充分描述的。然后净化水与透析液浓缩物混合形成透析液,透析液被供应给透析器15和流动平衡器系统,流动平衡器系统调节透析液向透析器15的流动以选择性地完成不同类型的透析,包括血液透析、超滤和血液透析滤过,如下面更充分描述的。透析系统将用过的透析液供应到排出口25。在一实施方式中,系统在用过的透析液去到排出口之前从用过的透析液回收热量。
透析系统的子系统
现在描述透析系统的各种子系统的实施方式,包括水净化系统5、透析液制备系统10、透析器15和流动平衡器系统20。应该理解,描述的内容是实施的例子,变化是可能的。
A.水净化子系统
图2表示水净化系统5的高层次示意图。水净化系统5包括多个子系统和/或组件,它们中的每一个都在图2中示意性地示出。虽然在净化水的背景下描述它,但水净化系统5可以用来净化除水之外的流体。水在入口位置105(来自图1中的供水系统7)进入流体净化系统并且当水沿着流动路径流向透析液制备系统10时与每个子系统和组件连通。子系统可以包括例如沉淀物过滤器系统115、活性炭过滤器系统120、反渗透系统125、超滤器系统130、辅助加热器系统135、脱气器系统140或其任意组合。
在离开流体净化系统5时,和在进入透析液制备系统10之前,流体处于净化的状态中。这优选地包括处于巴氏灭菌状态中的流体,尽管流体系统不必在所有情况下都给流体进行巴氏灭菌。图2中所示的实施方式是示例性的,并非图2中所示的所有组件都必需包含在水净化系统5中。包含在系统中的各单独组件可以不同,这取决于所需的净化或巴氏灭菌的类型和水平。图2中所示的沿着流动路径的子系统的数量和先后顺序是示例性的,并且应该理解,变化是可能的。
现在描述利用流体净化系统5净化水的方法,其包括通过系统的流体流动路径的描述。如所述的,水可以经由入口位置105进入水净化系统5。入口位置可以包括三通阀,其可以设置成使得从至少两个水源之一接收进入的水。一个这种水源可以是家庭水龙头。备选地,阀可以设置成接收循环水,循环水预先按规定路线通过水净化系统5并且再按规定路线回到系统中以便冲洗系统。当阀设置成接收循环水时,循环水可以在它流过水净化系统5时旁通绕过一个或多个子系统。
当阀设置成从家庭水龙头接收水时,进入的水可以首先流过至少一个沉淀物过滤器系统115,其包括一个或多个从流过的水中滤除沉淀物的沉淀物过滤器。在一实施方式中,沉淀物过滤器115移除小至5微米或甚至1微米的颗粒物质。压力传感器可以位于(多个)沉淀物过滤器的上游并且压力传感器也可以位于(多个)沉淀物过滤器的下游以便监视流动状态。另外,流动路径可以包含一个或多个压力调节器,其配置成调节流体压力以获得通过系统的所需流量。可以用(多个)压力调节器来补偿流量高于或低于所需范围的家庭水龙头。
然后水可以流过活性炭过滤器系统120,其可以包括一个或多个从水中滤除诸如有机化学物、氯和氯胺的物质的活性炭过滤器。在一实施方式中,活性炭过滤器系统120包括两个活性炭过滤器,样品口位于活性炭过滤器之间的流动路径中。样品口给操作者提供了接触流过系统的水的途径,例如为了质量控制的目的。在一实施方式中,至少一个压力传感器和至少一个电导率传感器位于活性炭过滤器系统120下游的流动路径中,电导率传感器提供了关于从水中移除的溶解固体的百分比的指示。另外,一个或多个泵可以位于沿着水流动路径的不同位置,例如在过滤器子系统之间。
水可以从活性炭过滤器系统120流到反渗透系统125,该反渗透系统125配置成从依据反渗透过程从水中移除颗粒。反渗透系统125可以从水中移除全部溶解固体的95%以上。反渗透系统125可以具有两个出口,包括废水出口126和纯水出口127。废水出口126从反渗透系统125输出废水。废水可以改道回到水路径的上游位置以重新进入反渗透系统125中。在这点上,诸如电导率传感器的传感器可以位于反渗透系统125的上游,作为检验水的内含物的装置。备选地,废水出口126可以将废水供应给排出口。
沉淀物过滤器系统115、活性炭过滤器系统120和反渗透系统125共同形成预处理阶段,该预处理阶段从水中移除大多数溶解固体、细菌污染和化学污染物,如果它们存在的话。因而水在离开预处理阶段时处于某程度的宏观净化状态中。因而,预处理阶段将比较干净的水供应给下游的(多个)泵以及下游的对水进行巴氏杀菌的热交换系统110。预处理阶段可以减少或消除在通过热交换系统110加热水的过程中的结垢和腐蚀。
一个或多个脱气器系统140可以位于热交换系统110上游和/或下游的流动路径中以从水中移除夹带气。脱气器系统140可以包括适合从水中移除夹带气的多种组件中的任一种。例如,脱气器系统140可以包括喷雾室和/或除泡器。
在水通过预处理阶段之后,水可以流过泵150,其将水泵入热交换(HEX)系统110。热交换系统110可以将水加热到实现水的巴氏杀菌的温度。在一实施方式中,热交换系统110是微流体热交换系统。在2010年6月7日申请的序列号为12/795382的美国专利申请和2010年6月7日申请的公开号为2010/0326916的美国专利申请中详细描述了微流体热交换系统的实施方式,其均通过引用全部并入本文中。
泵150可以用来将水压增大到高于在热交换系统110中遭遇的饱和压力的水平。这防止了热交换系统110内的水的相态变化。因而,如果在热交换系统110中达到的最高温度是150摄氏度,在该温度,水将会具有本领域技术人员公知的饱和压力,则从泵出来的水的压力将超过该饱和压力某一安全余量,例如10psi,以确保不会发生相态改变。泵可以将水压增大到处于或超过饱和压力的水平以确保没有局部沸腾。在热交换系统用于给水巴氏杀菌和水暴露于可能大于138摄氏度的高温(即充分高于水在大气压的沸点)的场合,这可能是重要的。
在离开热交换系统110之后,水可以进入节流阀160,例如限流器,其保持通过从泵150到热交换系统110出口的水路的压力。节流阀160和泵150可以被控制和调节以获得流量和所需压力配置。泵150和节流阀160可以在闭环系统中彼此通信以确保对于所需流量和温度保持所需压力。一个或多个温度传感器和/或流量传感器可以沿着热交换系统下游的流动路径放置以在控制泵150和节流阀160时使用。
在水离开节流阀160之后,它可以进到超滤器(UF)系统130,该超滤器系统130从水中移除大分子和所有或基本上所有的被巴氏杀菌过程杀死的死细菌以确保在混合透析液之前没有内毒素留在水中。大分子的存在可能对透析过程有害。然后,水可以通过加热器系统135,如果需要或希望,加热器系统135可以将水加热到所需温度,例如加热到正常体温(华氏98.6度)。从加热器系统135出来,水可以进入透析液制备系统10。
在一实施方式中,第二热交换系统位于加热器系统135上游的流动路径中。如果水高于预定的所需温度(例如37摄氏度),第二热交换系统可以用来进一步冷却从热交换系统110出来的水。第二热交换系统可以连接到单独的冷水源,于是该冷水将充当冷却剂,或者第二热交换系统可以连接到从反渗透系统125排出的水。在水源产生非常暖的水的环境中和/或当热交换系统110不能充分地冷却在透析中使用的水时,可以使用第二热交换系统。
B.微流体热交换器
如上所述,水净化系统5可以采用适合于给水巴氏杀菌的热交换系统110。图3表示微流体热交换系统110的一个实施方式的示意性的平面图,其配置成在不需要第二流体流给液体增加热量或从液体移除热量的情况下实现流过微流体热交换系统的液体(例如水)的巴氏杀菌。图3是示意性的,并且应该理解,流动路径的实际配置(例如流动路径的尺寸和形状)的变化是可能的。在2010年6月7日申请的序列号为12/795382的美国专利申请和2010年6月7日申请的公开号为2010/0326916的美国专利申请中详细描述了微流体热交换系统的实施方式,其均通过引用全部并入本文中。
如下面更充分描述的,微流体热交换系统限定了流体流动路径,该流体流动路径可以包括(1)至少一个流体入口;(2)通过至少一个加热器将进入的流体加热到巴氏杀菌温度的加热器区域;(3)滞留室,在那里,流体在预定时间段内保持处于或高于巴氏杀菌温度;(4)热交换区,在那里,进入流体从较热(相对于进入流体)的输出流体接收热量,并且输出流体在其向进入流体传递热量时会冷却;和(5)流体出口,在那里,输出流体以冷却的、巴氏杀菌的状态离开。取决于所需的输出流体温度,可以在下游使用一个或多个额外的热交换器以将输出流体的实际温度调节到例如在透析中使用的所需温度。这在较温暖的气候中是特别正确的,其中流入的水可能比在较冷的气候中供应的水高几十度,这将导致比所需的出口温度更高的出口温度,除非应用进一步的冷却。
在一实施方式中,流动路径至少部分地由一个或多个微通路形成,然而将如下面披露的微流体流场用于流体流动路径部分(例如热交换区)也处于本发明的范围内。通过提供减小的扩散路径长度和系统中反向流动路径之间的物质量,微通路的相对减小的尺寸增强了热交换系统的热传递速率。在一实施方式中,微通路具有至少一个小于大约1000μm的尺寸,微通路的尺寸可以变化并且一般设计成获得所需的热传递特性。水力直径在大约0.1至大约1mm范围内的微通路一般获得通过微通路的层流流体流,特别是在微通路的热交换区域中。微通路的小尺寸也允许热交换系统110紧凑且重量轻。在一实施方式中,微通路形成在一个或多个布置成堆叠配置的薄片中。
微流体热交换系统110的流动路径可以布置成反向流动路径配置。流动路径可以布置成使得较冷的进入流体以与较热的输出流体热连通的方式流动。较热的输出流体向较冷的进入流体传递热能以帮助加热器将进入流体加热到巴氏杀菌温度。将进入流体加热到高于其在入口处温度的温度的这个内部预热减少了加热器用来达到所需峰值温度的能量的量。另外,从输出流体向进入流体传递热能使得被预先加热的输出流体在通过流体出口离开之前冷却下来。因而,当流体进入微流体热交换系统110时,流体是“冷的”,然后在通过内部流体路径时流体被加热(首先通过热交换,然后通过加热器),并在其离开微流体热交换系统110时又是“冷的”。流体可以以第一温度进入微流体热交换系统110并被加热(通过热交换和通过加热器)到高于第一温度的第二温度。当流体沿着离开路径流动时,流体(处于第二温度)将热量传递给进入流体以使得流体降低到低于第二温度且高于第一温度的第三温度。
现在参考图3更详细地描述微流体热交换系统110的流体路径和对应组件的示例性实施方式,图3示出了卡销式热交换器,其具有在设备一侧上的入口和出口、中央的热交换部分和朝着相对端的加热区。流体可以通过入口282进入微流体热交换系统110。在所示的实施方式中,流动路径可以分支成一个或多个流入微通路284,这些流入微通路284定位成与流出微通路286呈反向流动布置。如所述的,微流体热交换系统110可以通过一堆成层的薄片形成。流入微通路284可以位于关于流出微通路286分开的多个层中以使得流入微通路284以交错的方式位于流出微通路286的上方或下方。在另一个实施方式中,流入微通路284和流出微通路286位于单个层上。
流出微通路286可以与出口288连通。在所述实施方式中,入口282和出口288位于微流体热交换系统110的相同端,然而入口282和出口288也可以相对于彼此位于不同位置。反向流动布置将流入微通路284放置在与流出微通路286热连通的位置。在这点上,流入微通路284中的流体可以沿着一方向向量流动,该方向向量定向成相对于流出微通路286中的流体流动的方向向量呈大约180度。流入和流出微通路也可以呈交叉流动配置,其中流入微通路284中的流体可以沿着一方向向量流动,该方向向量定向成相对于流出微通路286中的流体流动的方向向量呈大约180度至大约90度。流入微通路相对于流出微通路的定向可以以任何方式改变,只要其配置成在流入和流出微通路之间获得所需的热连通程度。
一个或多个加热器292可以放置成至少与流入微通路284热连通以使得加热器292能向在系统中流动的流体提供热量。加热器292可以放置在流入微通路284内以使得流体必须环绕加热器292的多个侧面流动。或者,加热器292可以放置到流入微通路284的侧面以使得流体沿着加热器292的一个侧面流动。无论如何,加热器292可以将热量传递给流体,该热量足以使流体的温度达到所需温度,在水被净化的情况下,所需温度可以包括巴氏杀菌温度。在一实施方式中,流体是水并且加热器292帮助在标准大气压下将流体加热到至少100摄氏度的温度。在一实施方式中,流体是水并且加热器292帮助将流体加热到至少120摄氏度的温度。在一实施方式中,流体是水并且加热器292帮助将流体加热到至少130摄氏度的温度。在一实施方式中,流体是水并且加热器292帮助将流体加热到至少138摄氏度的温度。在另一个实施方式中,流体是水并且被加热到在大约138摄氏度至大约150摄氏度范围内的温度。在另一个实施方式中,流体被加热到不会使流体汽化的最高可能的温度。
因而,微流体热交换系统110可以将流体保持为单相的液态。因为水典型地在大约100摄氏度从液态向气态改变其相态,所以可以给热交换系统增压以使得在上面所述温度加热的水始终保持在单相的液态。高于与热交换系统中最高温度对应的饱和压力的压力足以将流体保持在液态中。作为安全余量,压力可以保持在高于饱和压力10psi或更高。在一实施方式中,微流体热交换系统中的水的压力保持大于485kPa以防止水的沸腾,并且可以保持其显著超过该水平,例如620kPa或甚至高达900kPa,以便确保不会出现沸腾。可以利用泵和节流阀在热交换系统中保持这些压力。可以使用热交换系统上游的泵和热交换系统下游的节流阀,其中泵和节流阀在闭环控制机构(例如利用传感器)中操作以保持整个热交换系统中的所需压力和流量。
一旦流体被加热到巴氏杀菌温度,流体就可以进入滞留室294,其中流体保持被加热到巴氏杀菌温度或高于巴氏杀菌温度一个预定的时间量,其被称为“滞留时间”,或有时被称为“停留时间”。在一实施方式中,停留时间可以小于或等于一秒,在一秒和两秒之间,或至少大约两秒,其取决于流体的流动路径长度和流量。较高的温度能更有效地杀死细菌,较短的滞留时间意味着设备更紧凑。超高温巴氏杀菌定义成当水被加热到138摄氏度至150摄氏度的温度并持续至少大约两秒的停留时间时被实现,超高温巴氏杀菌被设计成杀死0.1CFU/ml到小于10-6CFU/ml浓度的微生物的所有菌落形成单位(CFU)(例如用于净化与不溶性透析液一起使用的水)。超纯透析液具有的细菌负荷不大于0.1CFU/ml。表1(在附图中示出)表明了实现各种水平的巴氏杀菌的所需温度和滞留时间。这里描述的热交换系统配置成实现表1中所示的各种水平的巴氏杀菌。
然后流体可以从滞留室294流到流出微通路286,在那里它流向流体出口288。如所述的,流出微通路286可以放置成与流入微通路284呈反向流动关系并且与流入微通路284热连通。以这种方式,输出流体(流过流出微通路286)与进入流体(流过流入微通路284)热连通。当加热的流体流过流出微通路286时,热能从加热的流体传递到流过相邻的流入微通路284的较冷流体。当流体流过流出微通路286时,热能的交换导致流体从其滞留室温度冷却下来。此外,当进入流体在到达加热器292之前流过流入微通路284时,进入流体通过热交换被预热。在一实施方式中,流出微通路284中的流体被冷却到不低于消除流体细菌侵染的最低可能温度的温度。当热交换系统给流体巴氏杀菌时,下降到所需净化水平的流体中的细菌在流体离开热交换系统时死亡。在这种情况下,流体在离开热交换系统之后的温度可以在用于透析中之前保持在室温。在另一个实施方式中,离开热交换系统的流体被冷却到处于或低于正常体温的温度。
尽管图3中的实施方式被表示为其出口通路被夹在流入通路之间,但通路的其他布置也能达到所需的加热和冷却程度以及加热器的能量要求。然而,对于所有实施方式而言共同的情况是系统内的所有流体路径都被设计成由单一流体通过,而不需要第二流体将热量加到该单一流体或从该单一流体移除热量。换句话说,在流体路径中的各个位置,单一流体依靠本身来加热和冷却本身。
微流体热交换系统110的尺寸可以改变。在一实施方式中,微流体热交换系统110足够小以拿在使用者的手中。在另一个实施方式中,微流体热交换系统110是单个本体,当干燥时其重量小于5磅。在另一个实施方式中,整个系统110的微流体热交换部分350具有大约1立方英寸的体积。可以选择微流体热交换系统110的尺寸以获得所需的温度和停留时间特性。
如所述的,微流体热交换系统110的一实施方式由彼此堆叠以形成多个薄片层的多个薄片状单元组成。所需的微流体流体流动路径可以蚀刻在每个薄片的表面中以使得当薄片彼此堆叠时,在薄片之间形成微流体通路或流场。此外,既可以用不穿透式蚀刻也可以用穿透式蚀刻形成薄片中的通路。特别地,穿透式蚀刻容许流体改变薄片的平面并移动到薄片堆的其他层。在一个实施方式中这出现在流入薄片的出口处,在那里流体进入加热器区,如下面描述的。穿透式蚀刻容许加热器区周围的所有薄片参与流体的加热而不是仅仅将流体保持在入口薄片的平面中。该实施方式提供了较大的表面积和较低的总流体速度以便于将流体加热到所需温度并且最终有助于设备的效率。
得自于薄片的不穿透式和/或穿透式蚀刻的微通路或流场形成流体流动路径。这里描述的微通路和流场可以至少部分地由一个或多个微流体流场形成,如2010年6月7日申请的序列号为12/795382的美国专利申请和2010年6月7日申请的公开号为2010/0326916的美国专利申请中披露的,通过引用将该两者全部并入本文中。
图7A表示形成至少一个入口路径的入口薄片305的实施方式的平面图,在入口路径,流体沿向内方向(如箭头307所示)流动通过热交换系统110。图7B表示形成至少一个出口路径的出口薄片310的实施方式的平面图,在出口路径,流体沿向外方向(如箭头312所示)流动通过热交换系统110。入口路径和出口路径可以各自包括一个或多个微通路。在某些实施方式中,入口和出口路径包括多个布置成平行关系的微通路。
图7A和7B表示彼此相邻放置的薄片305和310,然而在组装好的设备中,薄片以交错配置彼此堆叠。图7C表示彼此重叠的入口薄片305和出口薄片310,其示出了入口路径和出口路径。入口薄片305和出口薄片310可以彼此堆叠,其间具有流体管道,因此流体可以通过管道从入口路径流到出口路径,如下面更充分描述的。当堆叠时,传递层可以插入入口薄片305和出口薄片310之间。传递层配置成允许热量从出口路径中的流体传递给入口路径中的流体。传递层可以是能以对于所需应用足够的速率将热量从一个流体传导到另一个流体的任何材料。相关因素包括但不限于:热传递层110的导热性、热传递层的厚度和所需的热传递速率。合适的材料包括但不限于:金属、金属合金、陶瓷、聚合物或其复合物。合适的金属包括但不限于:不锈钢、铁、铜、铝、镍、钛、金、银或锡,和这些金属的合金。铜可能是特别合意的材料。在另一个实施方式中,在入口和出口薄片之间没有传递层,而是薄片本身充当流动路径之间的热传递层。
入口薄片305和出口薄片310都包括至少一个入口孔320和至少一个出口孔325。当入口薄片305和出口薄片310彼此堆叠且正确地对齐时,入口孔320对齐以共同形成贯穿所述堆且与入口薄片305的入口路径连通的流体路径,如图7C中所示。同样,出口孔325也对齐以共同形成与出口薄片310的出口路径连通的流体路径。可以将任意数量的入口薄片和出口薄片堆叠起来形成热交换系统110的多层入口和出口路径。可以选择层的数量以向微流体热交换系统110提供预定特性,例如用于改变流体中热交换的量、能由系统操纵的流体的流量等等。在一实施方式中,热交换系统110实现至少100毫升/分钟的进入液体流量。
仍参考图7A,入口路径和出口路径均包括热交换区域。热交换区域是指共同使用附图标记350和单独使用附图标记350a(用于入口路径)和附图标记350b(用于出口路径)。热交换区域350是入口路径的较冷流体(相对于出口路径中的流体)接收从出口路径的较热流体(相对于入口路径中的流体)传递来的热量的位置。如上面讨论的,流入路径中的比较冷的流体定位成以与流出路径中的比较热的流体热连通的方式流动。在该成层的实施方式中,当薄片堆叠时,流入路径的位置紧接在流出路径上方(或下方)。由于流入路径中的流体和流出路径中的流体之间的温差和分开两个路径的材料的导热性,热量越过传递层从流出路径中的流体传递到流入路径中的流体。如上所述,热交换区域也可以包括微流体流场而不是包括一连串的微通路。
仍参考图7A,流入路径中的流体从热交换区域350流入加热器区域355中。多个销357可以位于热交换区域350和加热器区域355之间的入口流动路径中(还看图8)。销357干扰流体流动并促进混合,其可以改善流体流动和热分布。在一实施方式中,流入路径在加热器区域355中分叉成至少两个流动路径以适应所需流量。替代地,可以采用仅仅一个通过加热器区域的流动路径,或可以选择三个或更多流动路径。加热器区域355包括一个或多个加热器220,其与流过该区域的流体热连通,但与流动路径密封地隔离。加热器220将热量加到进入流体,该热量足以将流体的温度升高到所需温度,所需温度可以包括巴氏杀菌温度。进入流体在它流过热交换区域350时被预先预热,这有利地减小了加热器的能量需求。加热器区域355既充当加热器220加热流体的区域又充当滞留室,在滞留室,流体保持被加热到所需温度或所需温度之上并持续一个预定的时间量。流体流动路径可以完全环绕每个加热器220以使得引导热量离开加热器220的任何垫片材料都可以具有在其上流过以接收热量的流体,由此将损失到环境中的热量减到最小。另外,环绕每个加热器220的流动路径可以比较狭窄从而避免由于与加热器220分离引起的不均匀的加热。
堆中的薄片可以包括在进入位置505处通向加热器区域355的穿透式蚀刻以使得进入加热器区域355的流体可以穿过堆中的所有薄片。穿透式蚀刻容许加热器区域355周围的所有薄片参与流体的加热而不是仅仅将流体保持在入口薄片的平面中,这在流体和加热器220之间提供了更大的表面积并且这还提供了较低的总流体速度以便于将流体加热到所需温度。
如所述的,流入路径可以分叉成多个流动路径。每个路径可以包括一个或多个布置在路径内的加热器220以便使加热器220和流过路径的流体之间的表面积接触量达到最大或以其他方式增大。在这点上,加热器220可以定位成朝向路径的中间以使得流体必须围绕加热器220的两侧环绕加热器220沿着半圆的或以其他方式沿曲线的路径流动。加热器220的配置可以变化。在一实施方式中,加热器220是直径为1/8英寸的传统的筒式加热器,其在一实施方式中可以以在大约70000和110000W/m2之间的组合率运行,对于整个堆以大约100毫升/分钟运行的情况,该组合率在一个实施方式中导致小于100W的能量使用,在另一个实施方式中导致小于200W的能量使用。在一实施方式中,系统使用六个加热器,其配置方式为每个流动路径三个加热器,其中每个加热器对于100毫升/分钟的流量耗能大约70W。在一实施方式中,迫使流体在1.6mm宽的路径中围绕加热器流动。加热器220可以包括150瓦特的McMaster-Carr筒式加热器(型号3618K451)。
仍参考图7A,流入路径从加热器区355过渡到滞留室360。在流体流入滞留室360之前,由于热交换区域350中的热交换和/或通过在加热器区355中加热,流体已经被加热到所需温度,例如巴氏杀菌温度。在堆叠多个薄片的情况下,滞留室360可以是跨越堆中的所有薄片层的单个室以使得来自每个入口薄片的流体流入滞留室360中的单个流体容积中。滞留室360配置成使得流体流动“捷径”被消除,迫使所有流体沿着流动路径移动以使得在规定流量下任何流体部分停留在滞留室360中的时间都不会小于所需持续时间,并且流体被保持在巴氏杀菌温度或巴氏杀菌温度以上的持续时间为流体在滞留室360内的时间(即,停留时间)。实际上,滞留时间是通过滞留区域的流动路径的尺寸和流量的结果。因而怎样为所需持续时间设计滞留路径对于本领域技术人员来说是明显的。
再参考图7B,出口路径在加热器220之间通过,加热器220充当流体的绝热器以减少流体在流动路径的这个阶段损失热量的可能性。然后,出口路径的被加热流体流向热交换区域350b。出口流动路径在达到热交换区域350b之前扩展,一组扩展扇状件367将流体引导到出口路径的扩展的热交换区域350b中,在那里流体与流入路径中的较冷流体热连通。如讨论的,来自较热的流出路径中的流体的热量传递到流入路径中的较冷流体,这导致流出流体的冷却和流入流体的加热。然后,流体从热交换区域350b流到出口孔325。在这个阶段,流体处于冷却的、被巴氏杀菌的状态中。
在热交换部分中分离通路的肋条的宽度可以减小,这将具有下列效果:增大可利用的热传递面积并减小设备的期望能量效率水平所要求的热交换部分的长度。能得到至少大约85%的能量效率水平,在某些实施方式中能得到至少大约90%的能量效率水平,这意味着来自输出流体的热能的90%能传递给进入流体流并被没有损失地收回。
如所述的,微流体热交换系统110可以由多个彼此堆叠并被扩散粘结的薄片形成。关于扩散粘结的其它信息由公开号为2008/0108122和2009/0092526的美国专利申请提供,其通过引用并入本文中。在一实施方式中,堆包括多组薄片,每个组都包括与出口薄片310并置的入口薄片305。每组并置的入口薄片和出口薄片形成单个热交换单元。因而薄片堆可以包括多个热交换单元,其中每个单元由耦联到出口薄片310的入口薄片305形成。每个薄片的流动路径可以通过在薄片的表面上蚀刻来形成,例如通过在每个薄片的仅仅一个侧面上蚀刻。当薄片被并置时,薄片被蚀刻的侧面密封毗连的、邻近的薄片的未蚀刻侧面。这可以提供所希望的热交换条件以及进入流体(其未被巴氏杀菌)和输出流体(其被巴氏杀菌)的分离。
图9表示薄片堆805的透视图。在堆的不同高度以局部横截面的方式示出了堆805,其包括最上面的出口薄片310、中间高度的入口薄片305a和较低高度的入口薄片305b。如所述的,堆805由彼此交错的交替的入口薄片和出口薄片形成,加热器220位于贯穿整个堆805穿过堆805中的所有薄片的切口内。滞留室360和对齐的入口孔320和出口孔325也完全贯穿堆805。薄片还可以包括一个或多个孔810,其在薄片堆叠时对齐以形成轴,对齐柱可以插入穿过该轴。薄片以实现正确的薄片对齐的方式堆叠。例如,当正确堆叠时,所有薄片的入口孔320对齐以共同形成流体流入系统中的入口通道且出口孔325对齐以共同形成出口通道,如图9中所示。正确对齐的薄片堆也可以包括一个或多个用于耦联堆中的加热器220的座部。一个或多个特征可以用于帮助堆中薄片的正确对齐,例如对齐柱和/或可见的正确对齐指示器。堆可以包括位于最上面的薄片上的顶盖和位于最底下的薄片上的底盖。
本领域中已知的透析系统可能是能源效率比较低的并且要求大量能量以便正确使用,这限制了它们在家用透析中的使用。在此描述的热交换系统110可以具有绝热的体系结构,其防止了通过其中的水的例如向外部环境的热损失。照此,全部功耗被减少或减到最少并且系统被最优化以便用于家用透析中。
在某些实施方式中,热交换系统110的薄片堆805包括外部的绝热外套。堆850也可以被装入绝热材料中以防止向外部环境的热损失。在其他实施方式中,堆805可以包括一个或多个绝热通路812,其可以防止或抑制从流场的一个或多个区域的热损失。如图10中所示,绝热通路812可以由一个或多个切口形成,所述切口各自贯穿堆中相应的薄片。切口可以如此定位以使得当薄片彼此正确堆叠时,切口彼此垂直地对齐。以这种方式,切口共同形成贯穿并横越堆中的所有薄片的室。在某些实施方式中,导致薄片粘附到彼此的堆形成方法可以导致通路812中局部真空的形成。真空可以增强通路812的绝热性。室充当防止或抑制来自流体路径的热损失的绝缘器。在这方面,室可以具有合适尺寸和形状以环绕流体路径的整个周界或部分周界延伸。例如,通路可以沿着流动路径的至少4、3、2或1侧延伸。在不同的实施方式中,通路环绕流动路径的周界的百分之50、60、70、80、90或95延伸。
通路可以具有配置成围绕一部分和全部流动路径的各种形状中的任一种。例如,在图10所示的实施方式中,每个通路812由三个直的节段形成,其环绕流动路径的三个侧面共同形成基本上“U”形形状。节段不必是直的,而是也可以是弯曲的。在另一个实施方式中,使用多个通路812,其中每个单独的通路仅仅包围流场的一部分并且该多个通路共同包围大多数流动路径。图11表示薄片的另一个实施方式,薄片包括一对热交换区域350,这些区域被供应来自入口320的流体。薄片可以包括两个或更多热交换区域350,这些区域全体地或单独地被用于使热交换区域绝热的通路812包围。在图12所示的又一个实施方式中,热交换区域350具有盘绕配置并且被类似盘绕的通路812包围。通路812用于使热交换区域350绝热。
堆805内的任一流体容积或路径都可以被一个或多个通路812包围。在某些实施方式中,至少热交换区域350基本上被一个或多个通路812包围。在另一个实施方式中,至少加热器区域355基本上被一个或多个通路812包围。或者至少滞留室360基本上被一个或多个通路812包围。在其他实施方式中,热交换区域350、加热器区域355和滞留室360基本上被一个或多个通路812包围。通路812可以充满物质或者可以是空的。在组装好的薄片堆中,通路被薄片本身沿着侧面封闭并且在顶部和底部被一个或多个板封闭以使得通路共同形成封闭室,该封闭室至少部分地包围薄片的流体路径。在使用系统时,系统内的压差可以使空气或任何其他流体从通路812排出从而形成真空或局部真空。真空用于将流体路径与外部环境隔离,防止或抑制热损失并最终减少系统的功耗。
C.透析液制备子系统
当水离开水净化系统5并流入透析液制备系统10时,水处于被巴氏杀菌的状态中。透析液制备系统10配置成将巴氏杀菌水与浓缩溶液的供应相混合以便制造透析液。图4表示透析液制备系统5的高层次示意图,图4的实施方式是示例性的并且应该理解,变型处于本发明的范围内。
透析液制备系统10可以包括酸泵170,其与用于与净化水混合的浓缩酸化透析液浓缩物的供应流体地连通。水可以从水净化系统5流到酸泵170,酸泵170将酸浓缩物泵送到水中。然后(与酸混合的)水可以流入第一混合室172中,该第一混合室172配置成例如通过产生湍流使水与酸混合。酸-水混合物可以从第一混合室172流向碳酸氢盐泵174。传感器,例如电导率传感器,可以位于第一混合室172的下游。电导率传感器配置成检测混合物中的电解质的水平。电导率传感器可以与酸泵170和控制系统闭环通信,所述控制系统可以调节酸泵的转速以获得泵送到水中的酸的所需水平。
碳酸氢盐泵174能以足以形成透析液的水平将碳酸氢盐浓缩物泵送到酸-水混合物中,最后得到的流体混合物流入第二混合室177中并且作为透析液离开第二混合室177。另一个传感器,例如电导率传感器,可以放置在第二混合室172的下游。第二电导率传感器可以与碳酸氢盐泵177闭环通信。然后,透析液可以流向流动平衡器系统和透析器。
D.透析器子系统
图5是透析器15的示意性横截面图,透析器限定了具有血液流动路径205的血液腔和具有被传递层分隔的透析液流动路径210的透析液腔,传递层由半渗透性的膜215构成。在一实施方式中,透析器包括一个或多个微流体路径,例如微型流场和/或微通路。在2010年6月7日申请的公开号为2010/0326914的美国专利中描述了采用微型流场和/或微通路的透析器和/或流场透析器的示例性实施方式,通过引用将其全文并入本文中。然而,透析系统可以使用各种各样的透析器中的任一种,包括各种各样的市场上可买到的透析器。
血液(来自患者)可以通过血液入口216进入血液流动路径205,流过血液流动路径205,并通过血液出口217离开。透析液可以通过流体入口218进入透析液流动路径210,流过透析液流动路径210,并通过流体出口219离开。半渗透性的膜215配置成容许一种或多种物质从血液流动路径205中的血液转移到透析液流动路径210中的透析液,或反之亦然。
可以用作半渗透性的膜215的材料的一些例子包括聚合物、共聚物、金属、陶瓷、复合材料和/或液膜。复合膜的一个例子是聚砜-纳米纤维素晶体复合膜,例如可从Gambro Medical得到的AN69平板膜。气-液接触器膜也可以用于在液体和气体之间转移物质,例如用于血液的充氧,藉此膜容许二氧化碳和氧的转移,以使得氧从氧气或富氧空气转移到血液中,并使二氧化碳从血液转移到气体中。也可以采用流体膜。流体膜可以包括具有穿透式切口微通路的薄片,其包含流体和第一与第二膜支撑件,第一与第二膜支撑件放置成将流体包含在微通路中。
当流过透析器15时,血液和透析液可以以反向流动的配置流动,其中血液沿一个方向流过血液流动路径205,透析液沿相反方向流过透析液流动路径210。虽然也可以使用交叉流动的配置,但是在具有反向流动的配置的情况下描述透析器15。当血液和水沿着膜215流动时,血液透析可以发生。透析器15也配置成执行超滤,其中膜215两侧的压差导致流体和溶解的溶质从血液穿过膜215到达透析液。
透析器15也配置成执行血液透析滤过,其中移动穿越半渗透性的膜215的溶质被对流而非被扩散支配。在血液流动路径205和透析液流动路径210之间的正的流体静压差驱动水和溶质从血液流动路径穿过半渗透性的膜215到达流体流动路径。小分子和大分子的溶质随同流体一起缓慢通过半渗透性的膜215。在典型的血液透析滤过过程中,水和溶质移动的方向可以在将水和溶质从血液移动到透析液中和将水和溶质从透析液移动到血液中之间振荡。在预定时间间隔上,具有从血液进入透析液的流体的净零损失和零净收益。然而,在该时间间隔内的不连续的时间段期间,可以具有从血液进入透析液中的流体的净损失和从透析液进入血液中的流体的净收益。
E.流动平衡器系统
图6表示包括透析器15的流动平衡器系统20的示意图。流动平衡器系统20适合调节进出透析器15的透析液的流动以实现不同类型的透析,包括血液透析、超滤和血液透析滤过。流动平衡器系统20可以包括用于将透析液泵入透析器的第一泵和用于将透析液泵出透析器的第二泵。系统还可以包括第三泵,其提供超滤、血液透析滤过或两者的水平的改进控制。通过改变泵的相对泵速,操作者可以改变血液过滤的水平并且还可以选择性地实现血液的超滤和血液透析滤过。
流动平衡器系统20可以包括形成多个流体流动路径的管道系统,其可以是任何类型的管道,诸如透析液的流体可以流过管道。流体流动路径可以包括入口路径250,诸如未用过的透析液的流体通过入口路径250从透析液制备系统10流向并流入透析器15。至少第一泵255沿着入口路径250放置或与入口路径250连通以便以所需流量将流体朝着透析器15泵送,一个或多个传感器S可以耦联到流体流动路径以感测进入流体的一个或多个特性,例如压力、流量、温度、电导率等等。另外,一个或多个样品口P可以耦联到流体流动路径,其提供了接触流过管道的流体的途径。图6示出了在规定位置耦联到流体流动路径的传感器S和样品口P,然而传感器S和样品口P的数量和位置可以改变。
流体流动路径还可以包括出口路径260,用过的透析液通过出口路径260从透析器15流向一个或多个排出口25。在某些实施方式中,在到达排出口25之前,离开透析器的透析液可以用来预热系统中的其他进入流体,例如进入热交换和净化系统的水流。出口路径260可以分叉成两个或多个出口路径,包括主要出口路径260a和次要出口路径260b。至少第二泵265可以沿着主要出口路径260a放置或与其连通以通过主要出口路径260a将透析液泵出透析器15并使透析液远离透析器15。
第三泵270可以沿着次要出口路径第二阀285放置或者与其连通。第三泵270可以用于增加通过流体流动路径的流体流,从而例如选择性地依据各种类型的透析(包括血液透析、超滤和血液透析滤过)来实现入口路径250和出口路径260之间的流速差别,如下文更详细地描述的那样。当系统处于透析模式时,第三泵可以通过流体流动路径泵抽透析液。当系统处于不同模式时,例如处于校准模式或清洁模式时,第三泵也可以泵抽其他流体,例如水或消毒剂。
第三泵270可以沿着透析器15的入口218上游的入口路径250放置。在该实施方式中,次要出口路径260在第一泵255下游和第一阀280上游的位置处从入口路径250分叉。第三泵270可以朝着排出口25泵送流体。在另一个实施方式中,第三泵270和第二泵265都沿着单一的、不分叉的流出路径放置。
各种类型的泵可以用于第一、第二和第三泵。在一实施方式中,泵是章动泵。在其他实施方式中,泵可以是旋转凸轮泵、螺杆泵、旋转齿轮泵、活塞泵、隔膜泵、螺旋泵、齿轮泵、液压泵、叶轮泵、再生(涡流)泵或蠕动泵,或其任意组合。也可以使用其他类型的泵。第一泵255和第二泵265可以由公共轴驱动以确保泵行程和所泵送流体体积的同步性。应该懂得,第一泵255和第二泵265也可以完全彼此独立。
如所述的,可以用各种流体管道中的任一种形成流动平衡器系统20的流体流动路径。在一实施方式中,流体流动路径的至少一部分由内径从1/8英寸至1/2英寸的管道形成。管道中的流量范围可以在大约50毫升/分钟至大约1000毫升/分钟之间。在一实施方式中,流量范围在大约100毫升/分钟和大约300毫升/分钟之间。
流体流动路径还可以包括旁路路径275,其直接流体地连接入口路径250和出口路径260。旁路路径275的示例性目的是提供流体流动路径,在该流体流动路径,流体可以流入和流出透析系统并旁通绕过透析器15,例如用于冲洗、清洁或校准系统。在一实施方式中,入口路径250和旁路路径275之间的交叉点位于透析器15的流体入口120的上游,旁路路径275和出口路径之间的交叉点位于透析器15的流体出口125的下游。然而,旁路路径275的其他配置也可以用来实现透析器15的旁路作用。
第一阀280可以位于入口路径250和旁路路径275之间的交叉点处,第二阀285可以位于旁路路径275和出口路径260之间的交叉点处。第一阀280和第二阀285可以是三通阀,例如电磁阀,其可以用来选择性地调节通过流体流动路径的流体流动。即,第一阀280可以设定成两种或更多种设定中的任一种,这些设定包括:(1)透析设定,其中第一阀将所有进入流体沿着入口路径250引导向透析器15(如图6中的箭头A所示)并防止进入流体流入旁路路径275;或(2)旁路设定,其中第一阀280将所有进入流体转向到旁路路径275中(如图6中的箭头B所示)并防止进入流体通过第一阀流向透析器15。
第二阀285也可以设定成两种设定中的任一种,这些设定包括:(1)旁路设定,其中第二阀285将来自旁路路径275的进入流体引导到出口路径260中(如图6中的箭头C所示);或(2)透析设定,其中第二阀285关闭来自旁路路径275的流动以使得来自透析器出口125的输出流体继续沿着出口路径260向外流动(如图6中的箭头D所示)。第一阀280和第二阀285一般合作地均被设定成旁路设定或透析设定。系统可以包括控制和安全系统,其确保第一阀和第二阀不会设定成不相容的设定。
图6中所示的透析系统的各种组件的布置是示例性的,其他布置是可能的。例如,流动路径和泵可以沿着流动路径安置在不同于图6中所示的位置中。在一实施方式中,第三泵270可以在流动路径中位于透析器15上游和第一阀280下游的位置,或第三泵可以位于透析器15的下游和第二阀285的上游。此外,系统可以使用多于三个的泵。
来自在此描述的系统中的净化水可以用于冲洗、准备和润滑各种子系统的各种泵的组件。例如,来自热交换系统110的净化水可以用于准备或冲洗透析液制备系统10(图4)的酸泵170和/或碳酸氢盐泵174的泵密封圈、泵压头和密封件。相似地,来自热交换系统110的净化水可以用于准备流动平衡器泵255、265、270(图6)中的一个或多个。用系统内部的净化水作为泵密封圈冲洗流体以润滑流动系统的头部减少了对来自外部来源的流体的需求并减少了系统的总耗水量,并利用了可从HEX系统得到的高纯水。在这点上,系统的管道系统可以包括专门用于将净化水引导到待冲洗的一个或多个泵的一个或多个流动路径。控制系统可以配置成自动将净化水引导到泵,或者控制系统可以配置成允许使用者选择性地将净化水引导到泵。
F.其他应用
如上所述,在此描述的流体净化系统可以用于除透析之外的目的。例如,水净化子系统5和特别是热交换系统110可以有益于流体(例如人类消耗的水源)的净化。此外,在此描述的流体净化系统不需要通过传统能源(例如通过插入电源插座)来提供动力。在此描述的流体净化系统可以通过可再生能源提供动力,包括太阳能、用户驱动的发电机或其他无电网能源。这些电源容许在紧急情况、电源故障、边远地区或任何其他远离电网的应用中使用系统,例如在世界的贫穷地区中,在那里不容易得到电并且可能高度需求干净的水。在某些实施方式中,热交换系统110可以耦联到用户驱动的发电机并且包括一个或多个电池,电池配置成运行小型电器并且能通过发电机充电。用户驱动的发电机可以例如通过用手或通过踩自行车上的踏板来摇转曲柄以给电池充电并给热交换系统110提供动力。
尽管本说明书包含许多细节,但这些细节不应被解释为对本发明要求保护的或可以要求保护的范围的限制,而应看作针对特定实施方式的特征的描述。在本说明书中在各单独的实施方式的上下文中描述的某些特征也可以在单个实施方式中组合实施。相反地,在单个实施方式的上下文中描述的不同特征也可以在多个实施方式中单独实施或以任何合适的方式组合实施。此外,虽然在上面可能将特征描述为在某些组合中起作用或甚至最初要求保护这些特征,但在某些情况下来自要求保护的组合中的一个或多个特征可以被从组合中删除,并且要求保护的组合可以被指向子组合或子组合的变型。相似地,尽管操作在图中被以特定顺序描述,但这不应被解释为要求以所示的特定顺序或以连续顺序执行这些操作,或执行所有所示的操作,来得到所希望的结果。
虽然在此参考某些方案详细描述了各种方法和设备的实施方式,但应该懂得,其他方案、实施方式、使用方法及其组合也是可能的,因而,所附权利要求的精神和范围不应局限于包含在本文中的实施方式的描述。
表1
Claims (9)
1.一种水处理设备,包括:
以堆叠关系布置以便形成薄片堆的至少第一薄片和第二薄片,每个薄片具有流体流场,所述第一薄片的流体流场配置成用于接收血液,所述第二薄片的流体流场配置成用于接收透析液;
所述第一薄片中的第一切口,其中所述第一切口包围所述第一薄片的流体流场的至少一部分;
所述第二薄片上的第二切口,其中所述第二切口包围所述第二薄片的流体流场的至少一部分,并且其中所述第一切口和第二切口在所述堆中垂直地彼此对齐以形成贯穿所述堆的集合切口;和
在所述堆的顶部上的第一板和在所述堆的底部上的第二板,其中所述第一板和第二板封闭所述集合切口的顶部和底部,形成对所述堆的流体流场的绝热室。
2.如权利要求1所述的设备,其中每个切口沿着流场的至少三个侧面包围各自的流场。
3.如权利要求1所述的设备,其中每个切口包围各自的流场的至少百分之八十。
4.如权利要求1所述的设备,其中所述堆包括超过两个薄片。
5.如权利要求1所述的设备,其中所述集合切口形成环绕所述堆的流体流场的U形。
6.如权利要求1所述的设备,还包括至少一个插入第一流场和第二流场之间的热传递层,当在操作中时血液的层透析横穿该热传递层发生。
7.如权利要求1所述的设备,其中绝热通路抑制从流场的一个或多个区域的热损失。
8.如权利要求1所述的设备,其中在所述绝热室内形成部分真空。
9.如权利要求1所述的设备,其中薄片的流体流场具有盘绕配置并且被盘绕的绝热室包围。
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Also Published As
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WO2013052680A2 (en) | 2013-04-11 |
EP2763719A4 (en) | 2015-07-01 |
ES2640953T3 (es) | 2017-11-07 |
AU2012318561B2 (en) | 2017-04-20 |
AU2012318561A1 (en) | 2014-05-29 |
EP2763719B1 (en) | 2017-08-09 |
EP2763719A2 (en) | 2014-08-13 |
CA2851245C (en) | 2019-11-26 |
WO2013052680A3 (en) | 2013-07-11 |
US9328969B2 (en) | 2016-05-03 |
US20130092361A1 (en) | 2013-04-18 |
CA2851245A1 (en) | 2013-04-11 |
CN103957960B (zh) | 2016-04-13 |
JP2014533133A (ja) | 2014-12-11 |
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