CN107727532B - 腹膜透析液流径感测 - Google Patents
腹膜透析液流径感测 Download PDFInfo
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- CN107727532B CN107727532B CN201710669451.8A CN201710669451A CN107727532B CN 107727532 B CN107727532 B CN 107727532B CN 201710669451 A CN201710669451 A CN 201710669451A CN 107727532 B CN107727532 B CN 107727532B
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- peritoneal dialysis
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- External Artificial Organs (AREA)
Abstract
本发明涉及用于感测在治疗期间注入患者体内和从患者移除的腹膜透析液的流体特性的系统和方法。所述系统和方法包括用于基于所述腹膜透析液的所述流体特性确定患者健康状况的传感器、处理器和流径。所述系统可以是腹膜透析循环机,所述腹膜透析循环机可以包括输注线路;流出线路;位于所述输注和/或流出线路中的至少一个泵;以及流体地连接至所述流出线路的至少一个传感器。所述传感器可以是流量传感器、离子选择性电极、pH值传感器、压力传感器、折射率传感器和温度传感器中的至少一者。所述方法可以包括经由输注线路注入腹膜透析液;经由流出线路移除腹膜透析液;以及确定所述流出线路中的所述腹膜透析液的至少一个流体特性。
Description
相关申请的交叉引用
本申请要求2016年8月10日提交的美国临时专利申请No.62/373,133的利益和优先权,本申请的全部公开内容以引用方式并入本文中。
技术领域
本发明涉及用于感测在治疗期间注入患者体内和从患者移除的腹膜透析液的流体特性的系统和方法。所述系统和方法包括用于基于腹膜透析液的流体特性确定患者健康状况的传感器、处理器和流径。
背景技术
腹膜透析(PD)是与血液透析(HD)不同的一种透析疗法,因为血液没有从体内移除并且经过透析器,而是将导液管放在腹膜腔中并且将透析液移除并直接引入腹膜腔中。血液是在患者体内使用患者自身的腹膜作为一类透析膜来进行净化。PD的两个主要类别是连续不卧床腹膜透析(CAPD)和连续循环腹膜透析(CCPD)(或自动化腹膜透析(APD))。在CAPD中,通过将一袋腹膜透析液放在肩部水平处并且使用重力将流体拉入腹膜腔中来连续地进行透析。之后将用过的透析液从腔中排出并丢弃。透析液在腔中的时段被称作滞留时间并且可以是30分钟至4个小时或更长。通常,在患者清醒时在24小时的时段中执行CAPD三次、四次或五次。CAPD不需要循环机来递送和移除流体。
确定注入患者体内和从患者移除的腹膜透析液的特定流体特性使得可以优化治疗并且在健康状态恶化的情况下进行早期的医疗干预。已知的系统未提供适当的机制来确定在治疗期间在腹膜透析中使用的透析液的流体特性。明确地说,已知的系统不允许感测从患者移除的废液或滤出液。
因此,需要用于确定腹膜透析液的流体特性的系统和方法。所述需要扩展到在治疗期间监测流体特性的系统和方法。还需要用于在治疗的过程中移除部分腹膜透析液以在腹膜透析液在患者的腹膜腔中时确定腹膜透析液的任何变化的系统和方法。
发明内容
本发明的第一方面涉及一种腹膜透析循环机。在任一实施方案中,所述腹膜透析循环机可以包括:组合式输注-流出线路,用于将腹膜透析液递送至腹膜腔以及从腹膜腔接收腹膜透析液;至少一个泵,所述泵位于所述组合式输注-流出线路中;以及至少一个传感器,所述传感器流体地连接至所述组合式输注-流出线路,其中所述至少一个传感器选自由以下各者组成的组:流量传感器、离子选择性电极、pH值传感器、压力传感器、折射率传感器、和温度传感器。在任一实施方案中,所述组合式输注-流出线路可以分开成两个不同的线路,所述线路可以被称作输注线路和流出线路。
在任一实施方案中,所述腹膜透析循环机可以包括:取样流径,所述取样流径流体地连接至所述组合式输注-流出线路,其中所述至少一个传感器位于所述取样流径中;阀,所述阀将所述组合式输注-流出线路连接至所述取样流径;以及至少一个泵,所述至少一个泵位于所述取样流径中。
在任一实施方案中,所述腹膜透析循环机可以包括流体地连接至所述取样流径的可拆卸取样储集器。
在任一实施方案中,所述腹膜透析循环机可以包括流体地连接至所述组合式输注-流出线路的腹膜透析液生成流径;所述腹膜透析液生成流径具有:水源;水净化模块;至少一个浓缩物源,所述浓缩物源流体地连接至所述腹膜透析液生成流径;以及至少一个传感器,所述传感器位于所述腹膜透析液生成流径或输注线路中。如果使用两个单独的输注线路和流出线路,那么所述腹膜透析液生成流径可以流体地连接至所述输注线路。
在任一实施方案中,所述腹膜透析循环机可以包括透析液再生模块;所述透析液再生模块流体地连接至所述组合式输注-流出线路以及所述腹膜透析液生成流径。如果使用两个单独的输注线路和流出线路,那么所述透析液再生模块可以流体地连接至所述流出线路。
在任一实施方案中,所述透析液再生模块可以位于所述取样流径下游。
在任一实施方案中,所述腹膜透析循环机可以包括与所述至少一个传感器通信的处理器;所述处理器从所述传感器接收数据并且将所述数据存储于机器可读存储媒体中。
在任一实施方案中,所述处理器可以包括输入/输出接口,所述输入/输出接口将来自所述至少一个传感器的数据提供给用户。
在任一实施方案中,所述腹膜透析循环机可以包括流体地连接至所述组合式输注-流出线路的取样口。如果使用两个单独的输注线路和流出线路,那么所述取样口流体地连接可以流体地连接至所述流出线路。
在任一实施方案中,所述取样口可以被可刺穿隔膜覆盖。
被公开为本发明的第一方面的部分的特征可以单独地或以组合方式存在于本发明的第一方面中。
本发明的第二方面涉及一种方法。在任一实施方案中,所述方法可以包括以下步骤:经由组合式输注-流出线路将腹膜透析液注入患者体内;以及确定所述流出线路中的所述腹膜透析液的至少一个流体特性。在任一实施方案中,所述方法可以包括以下步骤:经由单独的输注线路将腹膜透析液注入患者体内;经由单独的流出线路从所述患者移除腹膜透析液。
在任一实施方案中,所述方法可以包括将所述腹膜透析液从所述流出线路泵送至取样储集器的步骤;其中确定所述腹膜透析液的至少一个流体特性的所述步骤包括确定所述取样储集器中的所述腹膜透析液中的所述流体特性。
在任一实施方案中,所述方法可以包括在确定所述流体特性之前向所述取样储集器中的所述腹膜透析液添加一种或多种试剂的步骤。
在任一实施方案中,所述方法可以包括经由取样口从所述组合式输注-流出线路移除一部分流体的步骤,其中确定所述腹膜透析液的至少一个流体特性的所述步骤包括在所述所移除流体中确定所述流体特性。如果使用两个单独的输注线路和流出线路,那么可以使用所述流出线路来执行移除一部分流体的步骤。
在任一实施方案中,所述方法可以包括确定所述组合式输注-流出线路中的所述腹膜透析液的至少一个流体特性的步骤。如果使用两个单独的输注线路和流出线路,那么可以使用所述输注线路来执行确定所述腹膜透析液的至少一个流体特性的步骤。
在任一实施方案中,可以在所述组合式输注-流出线路、所述输注线路和所述流出线路中的任一者中确定至少一个流体特性。
在任一实施方案中,所述流体特性可以选自由所述流体的pH值与所述流体的体积组成的组。
在任一实施方案中,所述方法可以包括以下步骤:在第一时间时经由所述流出线路从所述患者移除所述腹膜透析液中的一部分;在第二时间时经由所述流出从所述患者移除所述腹膜透析液中的一部分;以及在所述第一时间和所述第二时间时确定所述流体特性。
在任一实施方案中,所述流体特性可以选自由pH值和一种或多种溶质的浓度组成的组。
在任一实施方案中,所述方法可以包括将所述流体特性传送至处理器中的机器可读存储媒体的步骤。
被公开为本发明的第二方面的部分的特征可以单独地或以组合方式存在于本发明的第二方面中。
附图说明
图1是用于感测流径中的腹膜透析液的流体特性的系统的示意图。
图2是用于感测腹膜透析液的流体特性的再生腹膜透析系统的示意图。
图3是示出了在腹膜透析液的样本中确定流体特性的方法的流程图。
具体实施方式
除非另外定义,否则所用的所有科技术语一般具有与本领域的普通技术人员通常所理解的意义相同的意义。
冠词“一”和“一个”用于指所述冠词的语法宾语中的一个或一个以上(即,至少一个)。举例来说,“一个元件”表示一个元件或一个以上元件。
术语“组合式输注-流出线路”是指用于递送流体以及从患者的腹膜腔移除流体的流体连接器。组合式输注-流出线路可以任选地分开成独立的输注线路和独立的流出线路。
术语“通信”是指两个组件之间的电子或无线链路。
术语“包含”包括但不限于跟在词语“包含”后面的任何东西。所述术语的使用表明所列出的元件是必要的或强制性的但其它元件是任选的并且可能存在。
“浓缩物源”是一种或多种溶质的源。浓缩物源可以具有溶质浓度大于将用于进行透析的溶质浓度的一种或多种溶质。浓缩物源中的浓缩物还可以低于透析中一般使用的溶质浓度以便生成低浓度透析液。
术语“浓度”和“溶质浓度”是指在给定量的溶剂中溶解的溶质的量。
术语“电导率传感器”是指能够测量流体的电导或电阻的任何组件。
术语“由……组成”包括并且限于跟在短语“由……组成”后面的任何东西。所述短语表明有限的元件是必要的或强制性的并且不可以存在其它元件。
术语“基本上由……组成”包括跟在术语“基本上由……组成”后面的任何东西以及不会影响设备、结构或方法的基本操作的额外的元件、结构、动作或特征。
术语“可拆卸”是指可以与本发明的系统、模块、盒或任何组件分开的任何组件。“可拆卸”还可以指可以用最少时间或努力从较大系统中取出的组件。在某些情况下,所述组件是用最少的时间或努力就可以拆卸,但在其它情况下可能需要额外的努力。所拆下的组件可以任选地再附接至所述系统、模块、盒或其它组件。
术语“确定”是指弄清系统或变量的特定状态。
术语“透析液再生模块”是指能够将废物从流体中移除的一个组件或多个组件。
术语“下游”是指流径中的第一组件相对于第二组件的位置,其中在正常的操作中流体将先经过第二组件再经过第一组件。第一组件可以说是在第二组件的“下游”,而第二组件在第一组件的“上游”。
术语“流出线路”是指用于从患者的腹膜腔移除流体的流体连接器。术语“流出线路”还可以指组合式流出-输注线路。
术语“流量传感器”是指能够测量移动通过导管的流体的体积或速率的任何组件。
“流体”是在流体中任选地具有气相与液相的组合的液体物质。明显地,液体因此还可以具有物质的气相与液相的混合物。
“流体特性”是流体的任何被感测特性,包括温度、压力、浓度、颜色或任何其它特性。
术语“可流体地连接”、“流体地连接”、“流体连接”、“可流体地连接”或“流体地连接”是指使流体、气体或其混合物从一个点传递至另一点的能力。所述两个点可以是在隔间、模块、系统和组件中的任何一者或多者内或之间,所述隔间、模块、系统和组件全都可以是任一类型的。
术语“注入”或将“注入”流体是指腹膜透析液至患者的腹膜腔中的移动。
“输注线路”是用于将腹膜透析液载运至患者的体腔或部分(诸如腹膜腔)中的流体线路。术语“输注线路”还可以指组合式流出-输注线路。
术语“输入/输出接口”是指处理器或计算系统的模块,所述模块允许数据被所述处理器或计算系统接收并且通过所述处理器或计算系统提供。输入/输出接口可以自动地接收和提供来自传感器的数据,或可以接收通过接口(诸如键盘)手动输入的数据。
“集成循环机”是用于将流体移入和移出患者的腹膜腔的组件,其中所述集成循环机形成整体系统的一部分。举例来说,集成循环机可以与用于腹膜透析的其它组件一起容纳在壳体中并且与所要组件成流体和电连接。
术语“离子选择性电极”是指能够基于检测到的电位确定流体中的特定离子的浓度的任何组件。
术语“机器可读存储媒体”是指能够以数字格式存储信息以便被计算机、处理器或其它电子装置读取的任何电子装置。
“患者”或“受试者”是任何动物物种的成员,优选是哺乳类物种,任选为人类。受试者可以是很健康的个体、患病的个体或正在治病的个体。
“腹膜透析液”是将用于腹膜透析中的、在纯度和无菌性上具有指定参数的透析溶液。腹膜透析液不同于血液透析中使用的透析液,但腹膜透析液可以用在血液透析中。
“腹膜透析液生成流径”是在生成适合于腹膜透析的透析液的过程中使用的路径。
“腹膜透析”是其中将透析液注入腹膜腔中的疗法,所述腹膜腔用作天然的透析器。一般来说,废物成分经由浓度梯度从患者的血流穿过腹膜扩散至透析溶液中。一般来说,呈血浆水形式的过量流体经由渗透梯度从患者的血流穿过腹膜流入透析溶液中。一旦注入的腹膜透析溶液已捕获到足量的废物成分,就移除所述流体。可以在每天或按需要来重复所述循环几个循环。
术语“腹膜透析循环机”或“循环机”是指用于在有或没有用于生成腹膜透析液或执行额外功能的额外组件的情况下将流体移入和移出患者的腹膜腔的组件。
术语“pH值”是指流体中的氢离子浓度。
术语“pH值传感器”是指能够测量流体中的氢离子浓度的任何组件。
术语“可刺穿隔膜”是指针头或注射器可以从中插入以从流径中抽出流体的组件。
术语“部分流体”是指少于流径、容器或储集器中的流体总量的一定量的流体。
术语“定位”是指组件的位置。
术语“压力传感器”是指能够确定由流体施加的力的任何组件。
术语“处理器”是广义术语并且被给予其一般的意义和本领域的普通技术人员惯用的意义。所述术语是指但不限于被设计成使用逻辑电路执行算术或逻辑运算的计算机系统、状态机、和/或处理器,所述逻辑电路对驱动计算机的基本指令作出响应并且处理所述指令。在第一、第二、第三和第四发明的任一实施方案中,所述术语可以包括与之相关联的ROM(“只读存储器”)和/或RAM(“随机存取存储器”)。
术语“泵”是指通过施加吸力或压力使流体或气体移动的任何装置。
术语“泵送”、“已泵送”或将“泵送”是指使用本领域的普通技术人员已知的任何一类泵来使流体移动或流动。
术语“试剂”是指将与第二物质反应以使溶液发生可观察到的变化的物质。
术语“接收”或将“接收”表示从任何源获得信息。
“折射率传感器”是能够检测光穿过流体的速度与光穿过水的速度的比率的任何组件。可以基于折射率来确定流体中的一种或多种溶质的浓度。
术语“移除”流体是指使流体从容器、系统或患者中流出。
术语“取样流径”是指从主流径改道的流径,在所述流径中可以确定取样流径中的流体的流体特性。
术语“取样口”是指流径中的流体口,通过所述流体口,可以移除流径中的部分流体来用于分析。
术语“取样储集器”是指与系统的其余部分分开的、用于收集部分流体以便对流体进行分析的容器。
“传感器”是能够确定系统中的一个或多个变量的一个或多个状态的组件。
“溶质”是溶解在或打算要溶解在溶剂中的物质。
术语“存储”或将“存储”是指将电子数据或信息保存在机器可读媒体中。
“温度传感器”是能够测量流体的温度的任何组件。
术语“发射”或将“发射”是指电子地发送信息。
“阀”是能够通过打开、封闭或堵塞一条或多条通路来引导流体或气体的流动以允许流体或气体在路径中行进的装置。被构造用于实现所要流的一个或多个阀可以被构造成“阀组合件”。
术语“体积”是指流体的量。
术语“水净化模块”是指能够将生物或化学污染物从水中移除的一个组件或多个组件。
术语“水源”是指可以获得饮用水的源。
腹膜透析流体路径感测
图1示出用于对从患者的腹膜腔10移除的腹膜透析液进行取样的系统100。系统100可以包括组合式腹膜透析液流出线路和输注线路128(本文中被称作流出线路)、腹膜透析液生成流径104、至少一个传感器106-106h、腹膜透析循环机116和计算装置120。导液管中的流出线路128具有用于废液的填充与移除的单个通道。本领域的技术人员将理解,可以使用单独的流出线路和输注线路。系统100可以在集成循环机中实现,其中腹膜透析循环机116包括形成用于对从腹膜腔10移除的腹膜透析液进行取样的系统100的腹膜透析液流出线路128、腹膜透析液生成流径104和至少一个传感器106-106h。替代地,腹膜透析循环机116可以是非集成的,不具有腹膜透析液生成流径104。腹膜透析液可以是离线制备的并且提供给循环机116。计算装置120可以是腹膜透析循环机116(无论是集成还是非集成的)的一部分,或可以是与传感器通信的单独装置。
腹膜透析液流出线路128可以流体地连接至废物储集器(未图示)以收集废液。任选地,取样流径130可以与腹膜透析液流出线路102流体连通以便分析所述流体。循环机中的阀(未图示)可以使流体从流出线路128转移至取样流径130。系统100可以使流经腹膜透析液流出线路102的废液的样本转移以允许在循环机116外部确定流体特性。所述样本可以是连续地或按特定间隔并且按预定量来进行转移。可以包括阀(未图示)以选择性地将腹膜透析液从腹膜透析液流出线路102转移至取样流径130中。泵(未图示)可以提供用于使腹膜透析液移动通过取样流径130的额外驱动力。可以通过将一定体积的所生成的腹膜透析液转移至取样流径130中来对所生成的腹膜透析液进行类似分析。对所生成的腹膜透析液的分析可以用作对新生成的腹膜透析液的质量检查以及通过将透析液的感测值与已知值进行比较进行对传感器的校准。对新生成的透析液的分析还可以被系统用于进行自我学习或机器学习以将透析液组合物调整至超过已知系统的能力范围的精度。对所生成的腹膜透析液的分析还可以用作安全系统以确保腹膜透析液中溶质的浓度是在预计值的预定阈值内。
替代地或另外地,系统100可以包括取样口134。取样口134可以流体地连接至腹膜透析液流出线路102。取样口134可以替代地流体地连接至取样流径130。取样口134可以被可刺穿隔膜覆盖。用户可以将针头或注射器插入穿过可刺穿隔膜以从流出线路102或取样流径130中抽出部分腹膜透析液。可刺穿隔膜可以在针头或注射器移除之后被重新密封以免污染腹膜透析液。
当用于集成循环机时,腹膜透析液生成流径104可以包括水源108、一个或多个水净化模块110、浓缩物源112、灭菌模块114和腹膜透析循环机116。浓缩物源112可以含有一种或多种溶质。水源108、水净化模块110、浓缩物源112、灭菌模块114和腹膜透析循环机116可以是可流体地连接至腹膜透析液生成流径104。腹膜透析液生成流径104可以流体地连接至组合式输注-流出线路128以将腹膜透析液注入腹膜腔10中。本领域的技术人员将理解,在单个浓缩物源的情况下,可以在不改变每一溶质的相对比例的情况下更改透析液中的溶质。在多个浓缩物源的情况下,每一单独溶质可以独立于所有其它溶质来进行调整。离子浓缩物源中的离子化合物的浓度还可以低于透析中一般使用的浓度以便生成低浓度透析液。可以使用任何数目的浓缩物源和浓缩物泵。可以使用单独的渗透剂源和离子浓缩物源来独立地调整渗透剂浓度和其它溶质浓度。可用于腹膜透析中的任何溶质可以包括在浓缩物源中。水源108可以是非净化水源,诸如自来水,其中来自水源108的水可以通过所述系统来净化。非净化水源可以提供未经另外净化的水,诸如来自市政水源的自来水、经过某一程度的净化但不满足所提供的“净化水”的定义的水(诸如瓶装水或过滤水)。水源可以含有满足在Guidelines for Drinking Water Quality,World Health Organization,Geneva,Switzerland,第4版,2011中提供的WHO可饮用水标准的水。替代地,水源108可以是净化水的源,表示满足在未经另外净化的情况下在腹膜透析中使用的适用标准的水。所述系统将水从水源泵送至水净化模块以移除流体中的化学污染物以便制备透析液。水净化模块可以是容纳阴离子和阳离子交换树脂和/或活性炭的吸附剂盒。所述系统可以将流体泵送至灭菌模块114以在腹膜透析液注入患者体内之前对腹膜透析液进行灭菌。灭菌模块114可以包括第一超滤器、第二超滤器和UV光源中的一者或多者、或其任何组合。灭菌模块可以是能够对腹膜透析液进行灭菌的任何组件或组件组。
浓缩物源112可以含有用于由净化水生成腹膜透析液的一种或多种溶质。利用浓缩物源112中的浓缩物来生成与透析处方匹配的腹膜透析流体。与处理器或计算单元通信的浓缩物泵(未图示)控制流体从浓缩物源112至腹膜透析液生成流径104中的移动。本领域的技术人员将理解,可以使用任何数目的浓缩物源,每一浓缩物源含有一种或多种物质的浓缩物。举例来说,浓缩物源112可以包括相组合的或在单独的浓缩物源中的任何数目的浓缩物。除了单个离子浓缩物源之外,还可以包括一个或多个渗透剂源。替代地,可以使用多个离子浓缩物源,其中每一离子浓缩物在单独的浓缩物源中。任何数目的浓缩物源中的浓缩物的任何组合可以用于本发明。所述浓缩物源可以输注每一特定浓缩物以提供比特定患者的规定量低的注入离子浓度。一个所要结果可能是使特定离子的浓度低于患者的透析前离子浓度。另外地,如果将通过浓缩物源来递送多个离子源,那么本系统可以在保持其它离子的浓缩水平的同时选择性地稀释所要离子。因此,本发明可以避免在新增稀释液可能会不利地影响已在正常范围中的离子浓度的情况下下调每一离子。
可以通过一个或多个传感器106-106h来确定从患者移除的腹膜透析液中的一个或多个流体特性。传感器106-106h可以流体地连接至腹膜透析液流出线路128、取样流径130、取样储集器132和腹膜透析液生成流径104中的一者或多者。为了与非侵入式传感器一起使用,传感器106可以位于流出线路128中,并且取样流径130可以是任选的。样本可以在处于腹膜透析液流出线路128、腹膜透析液生成流径104或取样流径130中时进行化验。另外地或替代地,样本可以从腹膜透析液流出线路102转移并且之后进行化验。举例来说,样本可以转移至流体地连接至腹膜透析液流出线路102的取样流径130中。样本可以通过取样流径130转移至流体地连接至取样流径130的可拆卸取样储集器132中以便将透析液从循环机116移除并进行离线化验。某些流体特性,诸如透析液的颜色或透明度,可能需要流出线路128或取样流径130中未包括的专门设备。可拆卸取样储集器132允许移除一部分腹膜透析液以便用不存在于流出线路128或取样流径130中的传感器来确定任何流体特性。样本可以是在处于取样流径130和/或可拆卸取样储集器132中时进行化验。替代地,可以将样本直接转移至单独系统,诸如血液分析仪,以进行分析。血液分析仪可以确定若干流体特性,所述血液分析仪可以包括在系统中。单独分析仪的一个非限制性实例是Nova Biomedical制造的StatCritical Care Xpress分析仪,然而,可以使用任何分析仪。单独分析仪可以与系统的处理器或计算单元通信以向系统提供分析结果。可以使用具有T形接头或阀的专用管件来将一定体积的流体转移至取样流径或单独分析仪中。在一个实施方案中,一个或多个传感器106-106h可以是在腹膜透析循环机116外部并且样本可以是在取样流径130中在腹膜透析循环机116外部进行化验。系统还包括用多个位置中的重复传感器进行重复分析。举例来说,同一类传感器可以包括在流出线路128与取样流径130中。替代地,可以包括单独分析仪,用于进行重复分析。分析的重复允许校准传感器并且用作安全检查以确保所述传感器正常工作。重复的传感器可以附接至循环机116或在单独系统中。
所述一个或多个传感器可以是单独的传感器或一个或多个组合传感器。所述一个或多个传感器106-106h可以是与腹膜透析液流出线路128、取样流径130、可拆卸取样储集器132和腹膜透析液生成流径104中的一者或多者流体连通并且位于其中或沿着其定位。
所述一个或多个传感器106-106h的多个实例示出于图1中。举例来说,流量传感器106a可以测量从患者移除的腹膜透析液的体积。溶质浓度传感器106b可以测量从患者移除的腹膜透析液的溶质浓度。溶质浓度传感器106b可以包括用于确定从患者移除的腹膜透析液的离子组分的浓度的电导率传感器或离子选择性电极。折射率传感器106c可以测量从患者移除的腹膜透析液中的葡萄糖或其它渗透剂浓度。电导率传感器106d可以测量从患者移除的腹膜透析液的电导率。压力传感器106e可以测量从患者移除的腹膜透析液的压力和/或在包括在输注线路104中时可以测量用于将腹膜透析液注入患者体内的压力。温度传感器106f可以测量从患者移除的腹膜透析液的温度。pH值传感器106g可以测量从患者移除的腹膜透析液的pH值。离子选择性电极106h可以测量从患者移除的腹膜透析液中的一种或多种特定溶质的浓度。表1提供可以确定各种溶质的溶质浓度的传感器和方法的非限制性实例。可以将表1中的试剂中的任何一者或多者添加至腹膜透析液以确定流体特性。本领域的技术人员将理解,可以使用替代的或额外的方法,并且可以合并本领域中已知的任何传感器或方法。
表1
参考表1中所列的试验,UV/可见光分光光度计是在可见或紫外光谱范围中工作的吸收光谱或反射光谱技术。UV/可见光分光光度计将化学样本暴露在预定波长的光下并且测量所产生的吸收或反射光谱。溶液的吸光率与吸收物质的浓度和路径长度成比例,因此可以使用校准曲线来量化未知样本的浓度,其中所述校准曲线是使用一连串具有已知浓度的样本来产生。通过测量280nm(A280)处的吸光率来确定蛋白质浓度是基于蛋白质溶液中的芳香氨基酸色氨酸和酪氨酸以及胱氨酸、二硫键半胱氨酸残基对UV光的吸收来进行。吸收与浓度相关,可以使用校准曲线来量化浓度,其中所述校准曲线是使用已知浓度的标准来产生。Bradford(考马斯)测定法将考马斯蓝染料与蛋白质在酸性/甲醇溶液中进行反应。蛋白质-染料络合物呈蓝色,而未键结染料呈褐色。可以通过测量595nm处蓝色的明度并且将其与校准曲线进行比较来量化溶液中蛋白质的量,其中所述校准曲线是用已知浓度的标准来产生。BCA(Smith)测定法主要依赖于两个反应。首先,蛋白质中的肽键将硫酸铜(II)中的Cu2+离子还原成Cu+(与温度相关的反应)。被还原的Cu2+的量与溶液中存在的蛋白质的量成比例。接下来,二喹啉甲酸的两个分子与每一Cu+离子螯合,形成强烈地吸收562nm波长处的光的紫色络合物。已开发出其它的市售蛋白质测定法以提供更强的特异性和/或解决可能会减少上述测定法的效用的干扰。其中许多测定法使用专有的染料分子,但所有的测定法全都使用制备蛋白质-染料络合物的一般程序,所述络合物导致可以用分光光度法检测到的颜色变化。钙离子(Ca2+)与邻甲酚酞络合剂在碱性溶液中反应以形成亮紫罗兰色的络合物,所述络合物在577nm处最大程度地吸光。可以添加2,3 8-羟喹啉以通过镁和铁移除干扰。在所述方法中,在570/660nm处用双色法来测量Ca-oCPC络合物的吸光率。反应混合物的吸光率的所致增大与样本中的钙浓度成正比。离子选择性电极(ISE)是将溶解于溶液中的特定离子的活度转换成电位的变换器(或传感器)。根据能斯特方程式,电压在理论上取决于离子活度的对数。ISE具有电极上面的涂层,所述涂层允许特定离子与电极相互作用,但排斥其它离子。许多类型的ISE是市场上可购得的,针对特定应用按需要具有不同的特异性和耐用性。ISE电极可用于钙、镁、钾和PD流体中的其它相关离子。可以使用利用葡萄糖氧化酶的传感器来量化葡萄糖。葡萄糖氧化酶是将葡萄糖氧化成葡萄糖内酯-1,5内酯+过氧化氢的酶。所生成的过氧化氢可以在铂电极上被还原以产生与浓度成比例的电信号。替代地,过氧化物可以与活性染料(诸如红试剂(10-乙酰基-3,7-二羟基吩恶嗪))络合以生成有色络合物,可以使用UV/可见光分光光度计来量化所述络合物。其它过氧化物活性染料是市场上可购得的,用于测量过氧化物浓度。
计算装置120可以包括一个或多个处理器122、存储器124和一个或多个输入/输出接口126。本领域的普通技术人员将认识到,存储器124可以包括长期存储器和操作存储器,和/或用作长期存储器与操作存储器的存储器。存储器124可以是机器可读存储媒体。存储器124可以与处理器122通信并且存储指令,所述指令在被执行时执行本发明的方法中的任一者。输入/输出接口126可以包括用于从一个或多个传感器106-106h接收信息的输入端口以及用于向用户输出数据(诸如关于样本的通知)的输出接口。处理器122可以与至少一个传感器106-106h通信并且将从至少一个传感器106-106h接收到的数据存储在存储器124中。如同本申请的所有特征一样,介入组件(诸如输入/输出接口126)可以存在于处理器122与传感器106-106h之间。计算装置120可以是独立于腹膜透析循环机116的单独装置,或可以是腹膜透析循环机116的一部分。计算装置120可以是与传感器106-106h网络通信(诸如经由因特网)的远程装置。
图2示出用于对腹膜透析液进行取样以确定从患者移除的透析液的一个或多个流体特性的替代系统200。系统200与系统100之间的差异是提供了腹膜透析液生成模块210。为简洁起见,省去了对与系统100的特征类似的一些特征的讨论。
腹膜透析循环机216可以包括泵218、组合式输注-流出线路228(本文中被称作流出线路)和透析液再生线路202。流出线路228可以流体地连接至在灭菌模块114下游的腹膜透析液生成流径204。腹膜透析液再生线路202可以流体地连接至在腹膜透析液再生模块210上游的腹膜透析液生成流径204。腹膜透析液再生模块210可以位于任选的取样流径230的下游。
某些流体特性的确定需要用到额外试剂或染料。在一个非限制性实例中,葡萄糖浓度的确定需要葡萄糖与葡萄糖氧化酶发生反应以生成过氧化氢。通过在过氧化物酶存在的情况下与4氨基安替比林(4-AAP)和苯酚反应而形成的过氧化氢得到红色喹诺密林(quinoeimine)染料,可以在505nm处用分光光度法来测量所述染料。替代地,过氧化氢可以与适当电极传感器发生反应,使得产生与葡萄糖浓度成比例的电流。类似地,可以通过任何合适的蛋白质生物测定法来检测腹膜透析液废液中的蛋白质含量。在一个非限制性实例中,考马斯亮蓝G-250染料与蛋白质发生反应以形成可以用分光光度法进行检测的有色络合物。色彩明度与蛋白质浓度成比例。本领域的技术人员将理解,可以使用替代试剂来确定相同或不同的流体特性。其中许多所述试剂在腹膜透析液再生以及再用时无法传回患者体内。取样流径230允许向在改道的流径中的、从患者移除的透析液添加必要的试剂,确保试剂不会传回透析液生成流径204中并且不会传回患者体内。不要求添加试剂的传感器可以替代地存在于流出线路128中,并且取样流径130是任选的。可拆卸取样储集器可以允许对从患者移除的一部分腹膜透析液进行离线分析。
系统200可以包括腹膜透析液流出线路228、腹膜透析液生成流径204、至少一个传感器106-106h、腹膜透析循环机216和如图1中所示的计算装置120。
图1和图2中的系统100、200的操作示出于图3中,图3是用于对从患者的腹膜腔10移除的腹膜透析液进行取样的示例性计算机化方法300的图示。在操作302中,方法300可以开始。在操作302中,腹膜透析会话可以是正在开始或已经在进行当中。
在操作304中,可以由系统100、200的处理器122发出开始腹膜透析会话的循环的控制信号,所述处理器控制腹膜透析液生成流径104、204的组件。可以经由流出线路128、228将腹膜透析液注入患者的腹膜腔10中。所述方法可以前进至操作306。
在操作306中,可以由系统100、200的处理器122发出结束腹膜透析时段的循环的控制信号。所述控制信号可以使腹膜透析循环机116、216开始所述循环的排放部分。可以经由腹膜透析液流出线路128、228将腹膜透析液从患者10的腹膜腔移除。所述方法可以前进至操作308。
在操作308中,可以由处理器122发出转移流经腹膜透析液流出线路128、228的腹膜透析液的样本的控制信号。操作308的多个实例描绘于图3中。举例来说,在操作308a中,控制信号可以致使样本从流经腹膜透析液流出线路128、228的腹膜透析液中移除并流入取样流径130、230中。在操作308b中,控制信号可以致使样本从流经腹膜透析液流出线路128、228的腹膜透析液中移除并流入可拆卸取样储集器132中。在任一实施方案中,可以将样本从流出线路128、228泵送出、经过阀进入取样流径130中并且任选地流入可拆卸取样储集器132中。替代地,可以从腹膜透析液流出线路128、228转移样本并且将样本直接转移至可拆卸取样储集器132或单独的分析仪中。在操作308c中,可以经由取样口将腹膜透析液从流出线路128、228移除。举例来说,可以机械地或手动地将注射器针头插入穿过可刺穿隔膜,并且可以移除一部分腹膜透析液以进行离线分析。替代地,传感器中的一者或多者可以位于流出线路128、228中,并且系统不需要转移一部分废液。方法300可以前进至操作310。
在操作310中,可以通过处理器122从传感器106-106h接收关于样本的数据。举例来说,与取样流径130流体连通的一个或多个传感器可以接收表示腹膜透析液的特性的数据。替代地,腹膜透析液流出线路128、228、腹膜透析液生成流径104、204或单独分析仪中的一个或多个传感器可以接收表示腹膜透析液的特性的数据。另外地或替代地,在操作312中可以通过处理器122分析在操作310中接收的数据以确定腹膜透析液的特性。在操作310中从所述传感器接收到的数据可以存储于机器可读存储媒体中。方法300可以前进至操作314,并且可以将从传感器接收到的数据传输给用户。再举例来说,与可拆卸流体储集器132流体连通的一个或多个传感器可以接收表示腹膜透析液流出线路128、228中的腹膜透析液的特性的数据。又举例来说,在使用取样口134移除腹膜透析液之后,一个或多个传感器106-106h可以输出来自样本的数据。在操作312中确定腹膜透析液的特性的步骤可以包括在使用取样口134移除腹膜透析液之后确定腹膜透析液的特性。
本领域的普通技术人员将认识到,可以通过图1和图2中的系统100、200的传感器106-106h对多个流体特性进行取样。表2列出了传感器106-106h的非限制性实例以及腹膜透析液的对应的取样特性。
表2
传感器 | 流体特性 |
流量传感器 | 流体的体积 |
折射率传感器 | 流体中的渗透剂浓度 |
电导率传感器 | 流体的电导率 |
压力传感器 | 用于递送/移除流体的压力 |
温度传感器 | 流体的温度 |
pH值传感器 | 流体的pH值 |
离子选择性电极 | 流体中特定离子的浓度 |
可以确定在输注线路中正注入患者体内的腹膜透析液与在流出线路中的腹膜透析液的流体特性。在输注线路与流出线路中确定流体特性使得可以在腹膜透析液在滞留时段期间在患者的腹膜腔内时确定腹膜透析液的变化。举例来说,注入患者体内的腹膜透析液的pH值和从患者移除的腹膜透析液的pH值允许确定在滞留时段期间pH值的变化。在滞留时段期间透析液pH值的下降可以表明患者体内的感染或弱的膜转移效率。可以使用输注线路和流出线路中的流量传感器来确定注入患者体内的腹膜透析液的体积和从患者移除的腹膜透析液的体积。注入患者体内的腹膜透析液的体积与从患者移除的腹膜透析液的体积之间的差值提供了来自患者的净流体移除或超滤。
所述系统可以在多个时间时将腹膜透析液转移至流出线路中。可以在第一时间和第二时间时移除患者的腹膜腔中的一部分腹膜透析液,允许确定流体特性的变化。透析液的pH值随着时间过去而减小可以表明感染或弱的膜转移效率。还可以通过在滞留时段期间在多个时间时测量透析液的溶质浓度的变化来计算膜转移效率。还可以使用在滞留时段期间在多个时间时测得的溶质的浓度来确定结束腹膜透析循环的最佳时间。举例来说,一种或多种溶质的浓度(包括渗透剂浓度)达到平稳状态可以表明患者与透析液之间的平衡已实现并且新的循环开始。
本领域的技术人员将理解,可以取决于操作的特定需要而对系统和方法进行各种组合和/或修改以及改变。被说明或描述为本发明的一方面的部分的特征可以单独地或以组合方式用于本发明的所述方面中。
Claims (17)
1.一种腹膜透析循环机,包括:
组合式输注-流出线路,用于将腹膜透析液递送至腹膜腔以及从所述腹膜腔接收所述腹膜透析液;
至少一个泵,所述泵位于所述组合式输注-流出线路中;以及
至少一个传感器,所述传感器流体地连接至所述组合式输注-流出线路,其中所述至少一个传感器选自由以下各者组成的组:流量传感器、离子选择性电极、pH值传感器、压力传感器、折射率传感器、电导率传感器和温度传感器;
其特征在于,所述腹膜透析循环机还包括:
取样流径,所述取样流径流体地连接至所述组合式输注-流出线路,其中所述至少一个传感器位于所述取样流径中;
阀,所述阀将所述组合式输注-流出线路连接至所述取样流径;
至少一个泵,所述至少一个泵处于所述取样流径中。
2.如权利要求1所述的腹膜透析循环机,还包括流体地连接至所述取样流径的可拆卸取样储集器。
3.如权利要求1或2所述的腹膜透析循环机,其还包括流体地连接至所述组合式输注-流出线路的腹膜透析液生成流径,其中所述腹膜透析液生成流径具有:
水源;
水净化模块;
至少一个浓缩物源,所述浓缩物源流体地连接至所述腹膜透析液生成流径;以及
至少一个传感器,所述传感器位于所述腹膜透析液生成流径中。
4.如权利要求3所述的腹膜透析循环机,还包括透析液再生模块;所述透析液再生模块流体地连接至所述组合式输注-流出线路和所述腹膜透析液生成流径。
5.如权利要求4所述的腹膜透析循环机,其中所述透析液再生模块位于所述取样流径下游。
6.如权利要求1所述的腹膜透析循环机,还包括与所述至少一个传感器通信的处理器;所述处理器从所述传感器接收数据并且将所述数据存储于机器可读存储媒体中。
7.如权利要求6所述的腹膜透析循环机,所述处理器包括输入/输出接口,所述输入/输出接口将来自所述至少一个传感器的数据传输给用户。
8.如权利要求1所述的腹膜透析循环机,还包括流体地连接至所述组合式输注-流出线路的取样口。
9.如权利要求8所述的腹膜透析循环机,其中所述取样口被可刺穿隔膜覆盖。
10.如权利要求1所述的腹膜透析循环机,其中所述组合式输注-流出线路包括单独的流径。
11.一种对权利要求1所述的腹膜透析循环机内的腹膜透析液进行分析的方法,包括以下步骤:
将腹膜透析循环机内的组合式输注-流出线路中的腹膜透析液样本送至取样流径;以及
确定腹膜透析液样本的至少一个流体特性。
12.如权利要求11所述的方法,还包括将所述腹膜透析液从所述组合式输注-流出线路泵送至取样储集器的步骤;并且确定所述取样储集器中的所述腹膜透析液中的至少一个流体特性。
13.如权利要求12所述的方法,还包括在确定所述流体特性之前向所述取样储集器中的所述腹膜透析液添加一种或多种试剂的步骤。
14.如权利要求11所述的方法,还包括经由取样口从所述组合式输注-流出线路移除一部分流体的步骤,并且确定所移除流体中的所述腹膜透析液中的至少一个流体特性。
15.如权利要求11所述的方法,其中在所述组合式输注-流出线路中确定至少一个流体特性。
16.如权利要求15所述的方法,其中所述流体特性是选自由所述流体的pH值与所述流体的体积组成的组。
17.如权利要求11所述的方法,包括以下步骤:在第一时间时经由所述组合式输注-流出线路从所述腹膜透析循环机移除所述腹膜透析液中的一部分;在第二时间时经由所述组合式输注-流出线路从所述腹膜透析循环机移除所述腹膜透析液中的一部分;以及在所述第一时间和所述第二时间时确定所述流体特性。
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CN111912744A (zh) | 2020-11-10 |
US10994064B2 (en) | 2021-05-04 |
EP3659643A1 (en) | 2020-06-03 |
EP3281658A1 (en) | 2018-02-14 |
ES2778443T3 (es) | 2020-08-10 |
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