CN103747816B - 液体清除治疗的心血管监测系统 - Google Patents

液体清除治疗的心血管监测系统 Download PDF

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CN103747816B
CN103747816B CN201280020933.6A CN201280020933A CN103747816B CN 103747816 B CN103747816 B CN 103747816B CN 201280020933 A CN201280020933 A CN 201280020933A CN 103747816 B CN103747816 B CN 103747816B
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blood
liquid
patient
electronic
control element
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CN103747816A (zh
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马丁·T·格伯
约翰·E·伯恩斯
S·吕
曼达·R·文卡特斯
布莱恩特·J·普迪尔
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Medtronic Inc
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Abstract

一使用包括：为一需要血液液体清除阶段的病人启动一血液液体清除阶段；监测病人的一心血管参数；确定心血管状况的指标是否超出了一预定的临界值；以及如果确定该指标超出了该临界值，则改变该血液液体清除阶段的一参数。

Description

液体清除治疗的心血管监测系统
相关申请
本申请要求申请日为2012年3月20日，申请号为13/424,490的美国专利申请的优先权，该美国专利申请要求申请号为61/480,539,61/480,544，61/480,541,61/480,535，61/480,532，61/480,530，以及申请号为61/480,528的美国临时申请的优先权，所述各优先权临时申请案的申请日均为2011年4月29日。所述各临时申请与本申请公开的内容不相矛盾的部分在此全部引用纳入本申请。
技术领域
本说明书大致涉及用于监测需要进行血液液体清除病人(例如肾脏疾病或心脏衰竭患者)的心血管状况的装置、系统和使用指示一血液清洁或液体清除。
背景技术
接受血液透析或从血液中清除液体和废物的其它治疗的病人经常会死于心脏并发症。很多可能的因素可导致这种死亡，包括由于这些病人体内液体量增加而在心脏上施加的压力。在一些情况下，液体量增加以及自身无法将废物从血液中清除也会导致电解质和pH值不平衡，这将影响心脏的收缩力和效率。此外，在血液透析或其它液体清除治疗期间，血液的液体量或pH值或电解质浓度的快速变化可能在心脏上施加额外的压力，并可能导致接受血液液体清除治疗病人的高发病率。
接受血液液体清除治疗(例如血液透析)的病人，通常有若干心血管参数，比如血压、心率或心律参数处于常规人群标准之外。例如，Secemsky等(Secemsky et al.)已经说明，接受长期血液透析的患者群体82％普遍有异常的心率变异性，75％普遍有异常的心率震荡，并且96％普遍有T波电交替(T-wave alternans)，这些都是心源性猝死的高概率指标(心律，2011年4月第8卷，第4号，592-598页(Heart Rhythm,vol.8,no.4,pp.592-598,April2011))。
通常，长期血液透析的病人接受周期性的检查，这使医疗服务提供者可以设定血液液体清除治疗的各种参数，比如，液体清除的分布图、所采用的透析液或置换液的成分等等。根据现行的医疗标准，如果病人没有其它急迫的健康问题，这些检查约一个月进行一次。但是血液透析或类似的治疗可能每周进行3至4次。这样，在改变处方(prescription)或参数前，病人可能接受10至15次或更多次血液液体清除阶段(session)。也有可能，例如在设定处方后的几天或几周后，关于透析液或置换液成分的处方将不适合病人。因此，可能希望更频繁地确定血液液体清除处方是否合适。另外，可能希望在一个血液液体清除阶段中以可以促进病人健康并减少发病率的方式来调整参数。
发明内容
本说明书公开了用于监测需要进行血液液体清除治疗的病人的心血管状况的装置、系统和使用，这些装置、系统和使用，以及使用监测到的数据来改变血液液体清除阶段。被监测的数据可以在血液液体清除阶段之间获得，以对处方进行调整，以考虑病人在距血液清除阶段更近的时间的心血管状态，与几天前或几周前的清除阶段进行对照。被监测的数据可以在一个阶段中获得，并且根据获得的数据可以在阶段中调节该血液液体清除阶段的参数。当调整阶段的参数时，可以继续进行心血管的监测以确定病人是否对液体清除参数的调节做出积极的反应。通过监测心血管参数，可以采用更合适的初始液体清除参数，或者可以在一个阶段中调节液体清除参数，以提高病人的安全性。
在此描述的各个实施例中，一种使用包括：为一需要血液液体清除治疗的病人启动一血液液体清除治疗；监测病人的一心血管参数(比如心率、心律或血压)；确定心血管状态的指标是否了一预定的临界值；以及若确定该指标超出了临界值，则改变血液清除阶段的一参数，该预定的临界值是基于在血液液体清除阶段开始之前获得的心血管参数的测量值的。
该使用还可以包括：在血液液体清除阶段开始前监测病人的心血管参数，以及根据在血液液体清除阶段开始前监测到的心血管参数设定一血液液体清除阶段的初始处方。血液液体清除阶段的初始处方可以包括一液体清除处方或一透析液或置换液的成分处方。
在此描述的实施例中，一系统，其包括：一血液液体清除装置，一用于监测一病人的一心血管参数的传感器装置(sensor)，以及电子控制装置，在一些实施例中，该电子控制装置可以置于血液液体清除装置内。所述血液液体清除装置包括：一入口，用于接收来自病人的血液；一出口，用于将来自病人的血液送回；一中间装置(medium)，用于清除血液中的液体和污物，其中该中间装置设在所述入口和第一出口之间的位置；以及一控制元件，用于控制所述中间装置从血液中清除液体的速度。所述电子控制装置可操作地与所述传感器装置和所述控制元件通信连接，该电子控制装置构造为通过控制元件来调节从血液中清除液体的速度。
在此描述的实施例中，一系统，其包括：一血液液体清除装置，一用于监测一病人的一心血管参数的传感器装置；一浓缩液源，用于容纳一包含液体浓缩成分的一浓缩溶液；一浓缩液流量控制元件，用于控制浓缩溶液进入液体源的速度；以及电子控制装置，在一些实施例中，该电子控制装置可以置于血液液体清除装置内。所述血液液体清除装置包括：(i)一入口，用于接收来自病人的血液；(ii)一出口，用于将来自病人的血液送回；(iii)一中间装置，用于清除血液中的液体和污物，该中间装置设在所述入口和第一出口之间的位置；以及(iv)一液体源，用于运输(carrying)一液体，例如透析液或置换液。如果该液体是透析液，所述液体源将该液体运输至所述中间装置。如果该液体是置换液，在血液流出中间装置后，所述液体源将该液体运输至血液。所述电子控制装置可操作地与所述传感器装置和所述浓缩液流量控制元件通信连接，该电子控制装置构造为通过该浓缩液流量控制元件根据从所述传感器装置获得的数据来调节浓缩溶液进入液体源的速度。
在此所描述的系统、装置和使用的一个或多个实施例较之现有的用于病人的血液液体清除的系统、装置和使用具有一个或多个优势。通过阅读下面的详细描述，这些优势对本领域的技术人员来说将是显而易见的。
附图说明
这些附图构成了本说明书的一部分，与说明书一起示出了本发明的几种实施方式，用来解释本发明的原理。附图只用于解释本发明的实施例，并不构成对本发明的限制。
图1-图3是示意性框图，其示出了血液液体清除装置与一病人的交互，示出了血液流动(虚线箭头)和液体流动(实线箭头)，该血液液体清除装置在这里所描述的各种实施方式中均可能用到。
图4是植入病人体内的一传感器装置的一实施例的一示意图。
图5是一示意性框图，其示出了一传感器装置的一实施例的一些选定部件。
图6是一植入传感器装置的一实施例的一示意图，该传感器装置构造为与一外部装置通信连接，该外部装置构造为与一遥控装置通信连接。
图7是一可由病人穿戴的传感器装置的一实施例的示意图。
图8-图9是示意性框图，其示出了流动路径和一些控制机构(闭环：图8；开环：图9)，该控制机构用于根据监测到的pH值或电解质控制浓缩液进入液体的流量，该液体是在一血液液体清除治疗中使用的。
图10-图11是血液液体清除装置的一些元件的示意性框图，其构造为调节液体的pH值或电解质浓度，以对与监测到的血液中的pH值或电解质水平的有关的数据作出响应。
图12-图13是流程图，其根据本文所描述的实施例示出了一般使用的概要。
这里所呈现的示意图不是必须按比例的。图中使用相同的数字指代相似的元件、步骤等等。然而，可以理解的是，在一个图中使用一个数字来指代一个元件，并非旨在限制该元件在另一图中也使用相同的数字标号。此外，使用不同的数字来指代元件，并非旨在表示不同标号的元件不能是相同或类似的。
技术方案详述
以下的详细描述引用了附图，附图构成实施方式的一部分，在附图中以示例的方式示出了装置、系统和使用的几种实施方式。可以了解的是，在不脱离本发明的范围和精神的情况下，其它实施方式也可以想到并做出的。因此，下面的详细描述不构成对本发明的限制。
这里所用的所有科技术语除非有特别的说明，都具有本领域的常用含义。此处的定义是为了便于理解这里经常用到的某些术语，并非意在限制本发明的范围。
如在本说明书和后附的权利要求中所用到的，单数形式的“一”和“该”包括具有多个所指物的实施例，除非本文内容清楚地表示了其他含义。
如在本说明书和后附的权利要求中所用到的，用语“或”通常是指包括“和/或”的含义，除非本文内容清楚地表示了其他含义。
如这里所用到的“具有”、“包含”、“包括”或类似的用语，是使用其开放式含义的，通常是指“包括，但不限于”的意思。
如这里所用到的“需要进行一血液液体清除治疗的病人”是一已经接受、正在接受或可能会接受至少一个血液液体清除阶段的病人。通常，这些病人是液体负荷过多的病人，比如患有心力衰竭、慢性肾脏疾病或急性肾衰竭的病人。通常这些病人是慢性肾脏疾病第3期至第5期的病人，对利尿剂无反应或反应低等等。
如这里所用到的“血液液体清除治疗”或类似语是指一个从病人的血液里将液体或者液体和溶质清除，再将血液送回到病人体内的过程。在大多数情况下，血液也被净化，即从血液中清除废物，干净的血液返回到病人体内。这些治疗的实例包括超滤、血液过滤、血液透析、腹膜透析、血液透析滤过等等。任何需要进行血液液体清除的病人都可以从这里所描述的装置、系统以及使用中受益。
本说明书还涉及装置、系统和使用，其用于监测需要进行血液液体清除治疗的病人的心血管状况，以及使用这些监测获得的数据来改变血液液体清除阶段。使用传感器装置来监测病人的心血管状况。该传感器装置可以植入病人体内、可以穿戴或置于病人体外。在实施例中，根据从传感器装置获得的数据设定用于一血液液体清除治疗的一初始处方。在实施例中，可以在一个阶段内根据该阶段内从传感器获得的数据改变血液液体清除治疗的参数。当调整阶段的参数时，可以继续进行心血管的监测以确定病人是否对液体清除参数的调节作出积极的反应。
任何用于将液体，或液体和污物，从血液中清除的适宜的装置或系统都可以根据本文的教示来使用。这些装置或装置的部件可以是传统的大型顾问式的，可穿戴的，或可植入的。
图1-图3示出了装置和系统的一些示例的框图。如图1所示，血液可以从病人10抽出，液体经过一血液液体清除装置100被清除，并流返至病人10。清除的液体可以被转移。在一些实施例中，血液液体清除装置100或系统或其部件被植入，可以将被清除的液体转移到病人的膀胱。血液液体清除装置100的实例是超滤和血液过滤装置，该装置可以如图1所示来运行。这些可以根据本文的教示使用的装置和其部件的实例在本领域内是公知的。可以理解的是，也可以采用将透析液引入到腹膜腔内的腹膜透析。
在其中一些装置中，由于用装置100以过大的速度或量将液体从血液中清除，所以可以将置换液导入病人血液中。置换液可以在液体清除前加入原始血液中，也可以在初始液体清除后、流返至病人的心血管系统前加入到血液中。优选地，置换液在初始液体清除后加入到血液中。置换液的pH值和电解质浓度可以设定或调节，例如，如下面更详细的描述，根据对病人心脏状况的监测来设定或调节。
如图2所示的实施例，血液液体清除装置100可以采用透析液来帮助病人血液中污物的清除，并且保持合适的pH值和电解质平衡。透析液的pH值或电解质浓度可以设定或调节，例如，如下面更详细的描述，根据pH值或电解质的监测来设定或调节。使用过的透析液和从血液中清除的液体可以被转移。在一些实施例中，尤其是在血液液体清除装置100或系统或其部件是可穿戴的或可植入的实施例中，使用过的透析液和清除的液体或它们的一部分可以再生出(虚线所示的再生系统150)新的透析液，以在血液液体清除治疗中再利用。透析液再生的一种系统是REDY系统，比如在Roberts,M，“再生透析(REDY)吸附剂系统”(theregenerative dialysis(REDY)sorbent system)，《肾脏病学》(Nephrology)4:275-278,1998中描述的，该系统可以用在这里所描述的实施例中，或简单修改后用在这里所描述的实施例中。如图2所示，可以向再生透析液中加入一浓缩液，以把再生透析液的pH值和电解质调节到一个像新透析液一样适合再使用的量。
不管透析液是否再生，以图2的实施例所示的方式运行的系统和装置包括血液透析和血液透析滤过系统。根据本文的教示可以采用的这些装置及其部件的实施例在本领域是公知的。可以理解的是，也可以采用将透析液导入到腹膜腔内的腹膜透析。
如图3所示，当图2的血液液体清除装置100以过高的速度从血液中清除液体时，在液体清除的上游或下游，可以将置换液引入病人的血液中，例如，如上文与图1相关的描述。
不管采用的装置或血液液体清除治疗是怎样的，重要的是具有一合适的初始液体清除处方以及透析液或置换液的合适的初始电解质浓度，其反映着病人在液体清除阶段那天或接近那天的心血管状态。可以期望的是，根据病人在治疗阶段的心血管系统的状态控制液体清除阶段的参数。通过监测病人的心血管状况，以及根据监测到的状况设定或修改一血液液体清除阶段的参数，可能会减少接受血液液体清除治疗的病人出现严重心脏疾病的情况。
透析液或置换液中的电解质或pH值缓冲液的浓度范围可能在一个血液液体清除阶段中是变化的，从而在一血液液体清除阶段之后达到一血液中的目标pH值和电解质浓度。在一个血液液体清除阶段期间或之后的pH值和血液电解质浓度的通常期望范围在下面的表1中列出。
表1：pH值和电解质的常用目标范围(参见《医学外科护理》(Medical SurgicalNursing),2007年第7版)
目标范围
pH 7.35-7.45
磷酸盐 2.8-4.5mg/dL
碳酸氢盐 22-26mEq/L
Cl- 96-106mEq/L
Mg2+ 1.5-2.5mEq/L
Na+ 135-145mEq/L
K+ 3.5-5.0mEq/L
Ca2+ 4.5-5.5mEq/L
然而，可以理解的是，某一病人的目标值可能与表1中所列的一个或多个电解质或pH值的值不同。也可以理解的是，缓冲液通常用于维持适当的血液pH值。
一些可以用于诸如置换液或透析液的液体中的合适的缓冲液包括碳酸氢盐，柠檬酸盐，醋酸盐，乳酸盐，氨基酸和蛋白质缓冲液。缓冲液及其组分的浓度和组成可以根据监测到的心脏状况进行调节。类似地，置换液或透析液中电解质(例如钠、钾、钙、氯化物)的浓度可以根据监测到的心脏状况设定或修改。
在一些实施例中，可以采用这里所述的使用、系统和装置，根据在一血液液体清除阶段开始之前进行的监测，来设置初始电解液浓度和初始pH值(缓冲液成分和浓度)。在一些实施例中，监测是长期的，例如，可以几天、几周、几个月或几年的间歇性地、周期性地或持续地进行监测。为了最少地干扰病人的生活，监测系统或其部件可以是可植入的或可穿戴的。
举例并参照图4-6，其示出了监测装置或系统的实施例，其具有可植入的或可穿戴的部件。在图4所示的实施例中，传感器装置200是全部植入病人10体内的，并且能够与病人体外的装置或其它植入的装置通过遥测技术或其它合适的通信方式通信连接。传感器装置200包括一装置本体201，其在一密封的壳体内容纳有电子元件。一传感元件205(比如一电极)通过一导线207与装置本体201的电子元件可操作地耦合。以这样的方式，装置本体201可以植入一从传感元件205移除的位置。在一些实施例中，传感器装置200是无线的，并且传感器(transducer)置于装置本体201中或装置本体201的一部分中，例如壳体的一部分中。不管是在一无线装置内还是在一有线装置200内，传感元件205均优选地置于本体内能够检测到关于心脏状况的合适信号的一个位置上。
例如，如果传感器装置200构造为检测心率或心律，传感元件205可以置于病人靠近心脏的其它任何可以检测到这些信号的位置。一个合适的构造为监测一病人的ECG信号的可植入传感器装置，是美敦力公司(Medtronic,Inc.)系列的植入式心脏监测器(insertable cardiac monitor)。在实施例中，该传感器装置可以是已经植入病人体内的适当安装的起搏器或除颤器。来自于这种装置的监测到的心脏信号可以传送给一血液液体清除装置或一中间装置，用于血液液体清除阶段或用于设定血液液体清除阶段的处方。
如果传感器装置200构造为检测血压，传感元件205优选地置于一血管内或一血管周围。可以置于病人的血管内的一无线压力传感装置的一个实例是美敦力公司(Medtronic,Inc.)的主动式无线压力传感器(active leadless pressure sensor，简称ALPS)，其通常以一支架的形式将所述装置固定在血管内。这一装置可以置于任何合适的血管内，比如一股动脉或肺动脉。
为了举例说明的目的，图5示出了一可植入的传感器装置200(例如如图4所示)的框图。示出的传感器装置是可植入的，并且具有一密封壳体299，用于容纳各种电子元件296，297，289，295。感测电路296(比如模数转换器、带通滤波器等等)可操作地与电源297和电子控制装置295耦合，电子控制装置295包括一处理器294和一用于存储感测到的数据和处理器指令的存储器293。感测电路296还通过导线207可操作地耦合到传感元件205(例如一电极或一压力传感器)。导线207通过一密封引线(未示出)进入壳体299。电子控制装置295与电源297可操作地耦合，电源可以是一电池或类似物，电子控制装置295还与遥测电路289可操作地耦合以与病人体外的一装置或其它植入病人体内的装置进行无线通讯。在一些实施例中，遥测电路289允许传感器装置直接向一血液液体清除装置或系统传输与一监测到的状况相关的数据，该系统或装置安装有一合适的遥测电路。在实施例中，所述传感器装置或其部件是一可植入血液液体清除系统的一部分。
现在参见图6，其示出了一传感器系统250的一实施例，其中植入的传感器装置200(示出的是无线的，但也可以如图4所示包括导线)，与一外部装置210通讯连接。该外部装置210可以穿戴并且可以进行一些由传感器装置200获取的数据的处理，以降低植入传感器装置200的电源消耗。该外部装置210也可以与遥控装置300通讯。当然，在一些实施例中，植入传感器装置200可以与遥控装置300直接通讯连接。
遥控装置300可以是与血液液体清除关联的装置，并且由外部装置210传送的数据可以用于在一血液液体清除阶段之前或期间设定或调节液体pH值和电解质浓度以及液体清除分布图。遥控装置300可以是连接到互联网或一电话网络的一计算机，个人数据助手等等，以使得检测到的数据或关于检测到的数据的其它信息可以传送到一医疗服务提供者。例如，该检测到的数据或关于检测到的数据的信息可以用于准备一合适的初始液体(比如透析液或置换液)，以用于病人的下一血液液体清除阶段。如果监测到的心脏状况超出了一设定的范围，则可以自动进行一个会见一医疗服务提供者的预约，或自动安排一血液液体清除阶段。在一些实施例中，遥控装置300是一医师编程器装置。当然，遥控装置300可以是任何其它合适的装置。
现在参见图7，其示出了一可穿戴的传感器系统200。传感器系统200包括一装置本体201，其容纳合适的电子元件(例如以上参照图6所讨论的电子元件)以及一个或多个传感元件203，205，比如电极或传感器。传感元件203，205，例如通过如图7所示的导线，与装置本体201内的电子元件可操作地耦合。可以采用任何合适的传感系统，例如一霍尔特传感系统(Holter sensor system)，其构造为监测病人10的ECG活动。一合适的可穿戴血压监测系统的实例是2010年3月9日授权的专利号为7,674,231，名称为“可穿戴脉搏波速度血压传感器及其校准的使用”(Wearable Pulse Wave Velocity Blood Pressure Sensor and UsesofCalibrationThereof)的美国专利中描述的一可穿戴的血压监测器。
如上所述的植入传感系统，一可穿戴的传感系统可以以任何合适的方式与一血液液体清除装置、遥控装置或植入装置通讯连接，该植入装置可以是一植入的血液液体清除系统。在实施例中，一可穿戴的传感系统是一可穿戴的血液液体清除系统或装置的一部分。
不管所采用的传感器装置200或其部件是可植入的、可穿戴的、一大型独立设备的一部分还是一血液液体监测装置的一部分，该传感器装置都可以监测病人任何合适的心血管参数。在各实施例中，传感器装置或监测系统构造为监测心率、心律或其一变量或血压中的一个或多个。可以测量的心律的变量的例子是心率变异性(HRV)、心率震荡(HRT)、T波电交替(TWA)、P波离散度、T波离散度、Q-T间期、室性早搏(VPD)等等。
一个或多个监测到的心血管参数可以用于为病人的下一血液液体清除阶段设定一合适的处方，或用于一血液液体清除阶段中的调节。由于这些心血管参数是公知的、被充分了解的并且是在文献中记录过的，本领域的普通技术人员可以很容易地理解根据这些参数开始或改变一血液液体清除阶段的方式。通过实例，如果病人的血压高或高于病人的正常值，那么可以降低液体清除的速度。如果病人的心率高(例如比一预定的临界值高)，则可以提高透析液钾浓度。
然而，可以理解的是，钾水平可能对于心率失常的管理尤其重要，并且血清钾浓度的突然变化能引起心率失常。因此，在很多实施例中，透析液和置换液中采用的初始钾浓度与病人体内的初始钾浓度相似，病人体内的初始钾浓度可如这里所描述的通过一传感器装置确定。进一步地，在一些实施例中，为了避免引起心率失常，可以减慢钾浓度的变化。还可以理解的是，液体清除的变化或者透析液或置换液中电解质浓度的变化与钾的变化不同，可以循序进行，而不是突然变化，以避免因突然变化引起的心率失常。
下面的表2提供了一些普通的例子，关于如何根据一监测到的心血管状况或参数改变一初始处方或改变在一血液液体清除阶段中的调整。
表2：根据心血管监测进行变化的例子
表2中的状态指的是一监测到的值相对于一预定的临界值或相对于某个病人的历史的状态。Na+浓度和K+浓度是在一血液液体清除阶段内所使用的液体(例如透析液或置换液)的浓度。可以根据监测到的数据将浓度从通常所采用的标准浓度(如以上参照表1所讨论的)调整到具体适合某一病人的浓度。在实施例中，最初，透析液或置换液中电解质的浓度与病人在治疗阶段开始时体内的电解质浓度是高度匹配的，并且例如在一个治疗阶段中，始终朝着目标范围逐渐变化。
可以在一个血液液体清除阶段的参数变化之前、之中或之后监测一个或多个心血管状况。如果病人的心血管状况随着调整继续恶化，则可以逆转血液液体清除阶段的变化或作出一不同的改变。如果病人的心血管状况随着血液液体清除阶段参数的变化而改善，参数的变化可以保持一段时间或者可以作些其它变化以确定是否可以获得进一步的改善。血液液体清除参数可以根据病人的安全性或病人的历史一次改变一个或一次改变多个。例如，如果病人之前表现出某一状况或几种状况组合的某一状态，并且之前对血液液体清除参数的调整的某些组合作出过积极的响应，那么可以同时实施这些调整。基于患者的历史参数的系统和使用在美国临时申请号为61/480,539的申请中有描述，患者的历史参数是在一血液液体清除阶段之前、之中或之后的，该申请的名称为用于血液液体清除的自适应系统，代理人案号是P0041918.00，申请日与本申请相同，上述临时申请在这里被全部引用纳入本申请中。
在一血液液体清除阶段期间，该阶段的参数可以以任何合适的方式进行调节，以达到期望的效果，比如改变液体清除的速度或改变液体的成分。以示例的方式，图8-图9示出了一血液液体清除系统的一些代表性部件，其构造为控制用于血液液体清除系统的一液体(透析液或置换液)的成分(例如各种成分的浓度)。图8是一闭环系统的实施例，图9是一开环系统的实施例。
参照图8，来自传感器装置200的数据显示在电子控制装置495上，该电子控制装置构造为控制流量控制元件415，425，435，例如阀。来自传感器装置的数据可以与电子控制装置495直接通讯，例如通过有线连接或遥测技术，或通过一与传感器装置200通讯连接的装置间接与电子控制装置495通讯。该电子控制的流量控制元件415，425，435与浓缩的电解质或缓冲溶液410，420，430，或者透析液或置换液的其它浓缩成分的供给管道液体连通，并与液体管道440液体连通，该液体管道440可以是一用于运输新透析液的导管或一用于运输置换液的导管。该电子控制的流量控制元件415，425，435通过电子控制装置495控制浓缩液410，420，430流进液体管道440的速度。浓缩液410，420，430被加入到体相流体(bulkfluid)400中，用于调节体相流体(以及血液)中成分(比如电解质)的浓度。
参见图9，来自传感器装置200的数据可以被处理，且适当的信息显示在一显示器600上，该显示器600可以是血液液体清除装置或一独立的计算机等的一部分。医疗服务提供者可以使用显示在显示器600上的信息来调节各成分(例如电解质)的浓度。例如，这可以通过一输入装置500传输一合适的指令给电子控制装置来实现。任何合适的输入装置500都可以采用。例如输入装置500可以是一键盘，一计算机，一平板电脑，一个人数据助手，一医师程序器等等。在某些实施例中，该输入装置500就是该显示器600，例如在显示器600是一触屏装置的情况下。不管指令如何输入，电子控制装置495都能够控制流量控制元件415，425，435，从而控制流入体相流体400的浓缩液410，420，430的量，体相流体400可以是透析液或置换液。
可以使用任何数量的合适的浓缩液。在实施例中，使用了一种浓缩液。这一种浓缩液可以包括，例如，希望控制的一种或多种电解质。使用一种以上浓缩液将允许独立控制或液体最终成分的更多变量，这在某些情况下是可取的。
控制元件415，425，435可以是任何适合的控制元件，例如电子控制阀，电子控制泵装置等等。
任何合适的系统可以被构造为如图8-图9所示，以根据从一个或多个传感器装置获得的数据对成分浓度的调节进行控制。作为示例，图10-图11示出了系统的两个实例的所选择的部件。图10中的系统示出了对一浓缩液进入置换液的流量进行的控制，图11中的系统示出了对一浓缩液进入透析液的流量进行的控制。图10-图11还示出了控制装置的一些实施例，其可以用于控制从一病人血液中清除液体的速度。
现在参见图10，其描绘的装置100包括在血液返回到病人体内前向血液中加入置换液的一液体流动路径。该装置100包括：一入口110，用于接收来自病人的血液；一出口140，用于将血液返回至病人体内。在入口110和出口140之间的流动路径上设有一血液流量控制元件120，以及一用于从血液中清除液体和污物的中间装置。该血液流量控制元件120与电子控制装置150可操作地耦合，该电子控制装置150提供指令以控制血液流经中间装置130的速度。通过中间装置130从血液中清除的液体和污物可以由出口180排出。
图10中示出的装置100还包括：一出口197，用于接收体相置换液；以及一置换液流量控制元件195，其与入口通信连接，并且设置为控制置换液加入到血液中的速度。电子控制装置150与置换液流量控制元件195可操作地耦合，并且构造为控制置换液流量控制元件195向血液中加入液体的速度。该装置100还包括：(i)一入口401，用于接收调节体相置换液的一种或多种成分的浓度的浓缩液；以及(ii)一浓缩液流量控制元件415，其与入口401通信连接，并且构造为在血液返回到病人体内前控制浓缩液加入到置换液或血液中的速度。优选地，浓缩液加入到置换液早于置换液加入到血液中(如图所示)，这样，浓缩液可以在加入到血液之前被混合或稀释。该装置可以包括一混合器(未示出)，其用于在加入到血液之前混合浓缩液和体相置换液。
在图10中所示的装置中，电子控制装置150与浓缩液流量控制元件415可操作地耦合，并且构造为根据来自一个或多个传感器装置200的数据控制浓缩液流量控制元件415向置换液或血液中加入液体的速度，该传感器装置200监测一心血管状况(例如如上所述)。通过控制浓缩液加入到置换液或血液中的速度，就能够控制返回的血液的一成分(例如一电解质)的浓度。
现在参照图11，图11中与图10具有相同或类似编号的部件表示相同或类似的部件，其示出了一血液液体清除装置100的所选定的部件的示意框图。在图11所示的实施例中，该装置具有：一入口110，用于接收来自病人的血液；一血液流量控制元件120，其与入口110通信连接，并且构造为控制血液流经中间装置130以从血液中去除液体和污物的速度。该装置还包括一出口140，其与中间装置130连通，用以将血液返回到病人体内。在所示的实施例中，中间装置130包括一半渗透过滤膜(filter)135，例如一血液透析过滤膜或血液透析滤过过滤膜。该膜将一血液流动腔体与中间装置130的一透析液流动腔体分开。
在图11中所示的实施例中，使用过的透析液通过流经透析液再生中间装置402或部件(例如REDY再生中间装置和部件等等)来再生出体相透析液。该装置还具有一出口180，其与中间装置130连通，用于将从血液中清除的液体转移出该装置。一流量调节元件700(比如一阀)与电子控制装置150可操作地耦合，并设置在中间装置130和出口180之间的流动路径上，以控制流出该装置的液体量(因为部分液体已经再生)。含有浓缩成分(例如一种或多种电解质)的浓缩液可以在透析液再次进入中间装置130之前被加入到再生的透析液中。
在该示出的实施例中，浓缩液410存放在一储液器410中，储液器具有一入口401，其允许不时地向储液器410补充浓缩液。浓缩液加入再生透析液的速度根据来自传感器装置200的数据由浓缩液流量控制元件415控制，该浓缩液流量控制元件415与电子控制装置150可操作地耦合，该传感器装置200监测pH值或电解质浓度(例如如上所述)。
图11中的装置100还包括一透析液流量控制元件170，用来控制透析液流入中间装置130的透析液流动腔体的速度。
在示出的实施例中，该装置100还包括一负压控制元件190，其与中间装置部件130的透析液流动腔体通讯连接。该负压控制元件190可以包括一泵或类似物，其可以用于产生或改变一穿过所述膜的压力差，来控制液体从流经中间装置部件130的血液里清除的速度。
电子控制装置150可以包括一处理器，一存储器等，该电子控制装置150与血液流量控制元件120、透析液流量控制元件170和负压控制元件190可操作地耦合，且构造为控制该血液流量控制元件120、透析液流量控制元件170和负压控制元件190。通过协调控制这些元件，可以控制液体从血液中清除的速度。可以理解的是，装置100不需要具有图11所示的所有这些控制元件120,170,190以有效控制液体从血液中清除的速度。
如图10和图11所示的各种控制元件120，150，170，195，415，其可以使用任何适合的控制元件。例如，可以采用一速度可变或可调的泵。可选地或附加地，可以采用一系列电子控制阀。在某些实施例中，这些阀与具有不同流动阻力的流动路径相连接。
可以理解的是，这里所述的血液液体清除装置和系统及其部件呈现的目的在于举例说明，而并非限制。不同于这里所描述的部件、装置和系统，或者所述部件、装置和系统的衍生，都可以被采用。进一步地，可以理解的是，在各个附图中，比如图1-图3，所描绘的这些血液液体清除装置是以在病人体外示出的，如果这些装置或其部件是植入病人体内的，这里所呈现的教导也是适用的。
以上所述的装置和系统或其部件，可以用来实现下文所述的和图12-图13所示的使用或部分使用。当然，任何适合的装置或系统都可以用来实现下文所述这些使用或部分使用。可以理解的是，以下图12-图13中任意一个所呈现的使用中的各个步骤是可以交换顺序的、可替代的，或可加入到图12至图13中另一个所呈现的步骤中去。
现在参见图12，该示出的使用包括监测病人的一心血管指数800；例如如上所述。所述监测800可以是长期的，并可以使用一个或多个可植入或可穿戴的传感器装置。该使用还包括确定监测到的心血管参数是否超出一预定的范围810。如果该参数确定超出了预定的范围值，则可发出一报警820。该报警可以是一给病人的报警，例如一振动或声音报警，由一传感器装置或一与传感器装置通讯连接的装置发出。该报警可以是一给医疗服务提供者的报警，其可以通过互联网或一合适的电话网络等等从传感器装置或与传感器装置通讯连接的装置发送至与医疗服务提供者通讯连接的一装置。可以自动安排一液体清除治疗阶段。
如果监测到的心血管参数并没有超出预定范围(或在一些情况下，即使超出了预定范围)，在监测阶段800获得的数据用于设定一血液液体清除阶段的初始参数830。这个阶段的初始参数可以包括血液液体清除速度、血液液体清除分布图或血液液体清除量，或者在清除阶段所使用的液体(例如透析液或置换液等等)成分的组成和浓度。如上所述，不同于现行的操作准则，长期监测病人的心脏参数的能力使得在各阶段之前定制一血液液体清除阶段的参数成为可能，在现行的操作准则中，液体成分是一个月调节一次(或大概一个月一次)。由于一个月内可能会进行多次血液液体清除阶段(例如每周2至3次)，因此一个月设定一次阶段参数就可能导致病人以可能不再适合该病人的阶段参数接受好几个血液液体清除阶段。
仍参见图12，一旦设定了初始阶段的参数830，就可以启动血液液体清除阶段840，并继续监测心血管参数850。确定监测到的心血管参数是否超出了一第一较高的阈值范围810或一第二较低的阈值范围860。如果参数超出了第一范围810，则发出一报警820(如上所述)，以及在某些情况下，可以停止血液液体清除阶段880。如果心血管参数没有超出第一范围810，但超出了第二范围860，则可以根据监测到的心血管参数(例如如上所述)改变血液液体清除的参数870。可以以类似的方式根据需要做进一步的改变。
如果心血管参数没有超出第一范围810或第二范围860，则可以以初始设定参数继续进行血液液体清除阶段。
现在参见图13，其示出了通过一血液液体清除系统或装置来实施的一使用。该使用包括：接收关于一监测到的心血管参数的数据900，以及根据接收到的数据设定或调节一血液液体清除阶段的一参数。该系统或装置具有电子控制装置，其构造为根据接收到的关于心血管参数的数据来设定或调节治疗阶段的参数。
这里所述的很多使用，包括图12所示的使用或其部分使用，可以由传感器装置、血液液体清除装置或其他与传感器装置或血液液体清除装置连接的装置实施。这些使用可以是编入该装置的存储器内的逻辑运算或指令，其可以由该装置的处理器或其它电子控制装置来完成。优选地，该处理器与装置中合适的控制元件通讯连接，并且构造为通过程序指令来控制这些元件，这些程序指令由合适的装置执行。可以理解的是，如上文所述，一编写有使一传感器装置、血液液体清除装置或其它适合的装置执行一使用或部分使用的指令的计算机可读介质是可以想到的。该计算机可读介质可以是非瞬时的(non-transitory)，即持续时间长于一瞬间或几秒钟。该介质可以是存储器，比如RAM或ROM，一CD或DVD，闪存等等。
这里描述了使用、装置、系统、计算机可读介质等等的各种变化情况。下面介绍某些情况的概述。
第一种情况，通过一血液液体清除装置或系统实施的一使用，其包括：(i)为一需要血液液体清除阶段的病人开始一血液液体清除阶段；(ii)监测病人的一心血管参数；(iii)确定心血管状态的指标是否超出了一预定的临界值；以及(iv)如果确定所述指标超出了临界值，则改变血液液体清除阶段的一参数。
第二种情况是第一种情况的一使用，其中所述预定的临界值是基于在血液液体清除阶段开始前所获得的心血管参数的测量值的。
第三种情况是第一或第二种情况的一使用，其还包括：监测病人在血液液体清除阶段开始前的心血管参数；以及根据在血液液体清除阶段开始前监测到的心血管参数设定血液液体清除阶段的一初始处方。
第四种情况是第三种情况的一使用，其中设定血液液体清除阶段的初始处方包括设定一液体清除处方或设定一透析液成分处方。
第五种情况是第四种情况的一使用，其中监测病人在血液液体清除阶段开始前的心血管参数包括长期监测心血管参数。
第六种情况是第五种情况的一使用，其还包括：(i)确定心血管参数是否超出了一预定的临界值；以及(ii)如果该参数超出了临界值，则安排血液液体清除阶段或发出一报警。
第七种情况是第1-6种情况中任意一种的一使用，其中监测心血管参数包括监测心率、心律或血压中的一个或多个。
第八种情况是第1-7种情况中任意一种的一使用，其中改变血液液体清除阶段的参数包括改变从病人血液中清除液体的速度。
第九种情况是第1-8种情况中任意一种的一使用，其中改变血液液体清除阶段的参数包括改变一液体的一成分的浓度，该液体选自透析液或置换液。
第十种情况是，通过一血液液体清除装置或系统实施的一使用，其包括：(i)接收关于一监测到的心血管参数的数据至一血液液体清除装置或系统；以及(ii)根据接收到的关于监测到的心血管参数的数据设定一血液液体清除阶段的一参数，其中所述参数由一血液液体清除装置或系统的电子控制装置来设定。
第十一种情况是第十种情况的一使用，其中设定血液液体清除阶段的初始处方包括设定一液体清除量处方。
第十二种情况是第十或十一种情况的一使用，其中设定血液液体清除阶段的初始处方包括设定一透析液成分或一置换液成分。
第十三种情况是第10-12种情况中的任意一种的一使用，其中所述心血管参数包括心率、心律和血压中的一个或多个。
第十四种情况是一系统，其包括：(a)一血液液体清除装置，其包括：(i)一入口，用于接收来自病人的血液，(ii)一出口，用于返回来自病人的血液，(iii)一中间装置，用于清除血液中的液体和污物，该中间装置设于所述入口和第一出口之间，以及(iv)一控制元件，用于控制所述中间装置从血液中清除液体的速度；(b)一传感器装置，用于监测病人的一心血管参数；以及(c)电子控制装置，其可操作地与所述传感器装置和所述控制元件通信连接，其中该电子控制装置构造为通过控制元件调节液体从血液中清除的速度。
第十五种情况是第十四种情况的一系统，其中所述血液液体清除装置还包括：一液体源，用于运输一系统液体，该系统液体选自透析液和置换液，其中，如果该液体是透析液，则所述液体源将该液体运输至所述中间装置，如果该液体是置换液，则在血液流出中间装置后，所述液体源将该液体运输至血液；其中所述系统还包括：(i)一浓缩液源，用于容纳一浓缩溶液，该浓缩溶液包含系统液体的一浓缩成分；以及(ii)一浓缩液流量控制元件，用于控制浓缩溶液进入液体源的速度，其中所述传感器装置可操作地与电子控制装置耦合，并且所述电子控制装置进一步构造为根据从所述传感器装置获得的数据，通过所述浓缩液流量控制元件来调节浓缩溶液进入液体源的速度。
第十六种情况是第14或15种情况的一系统，其中所述电子控制装置置于所述血液液体清除装置内。
第十七种情况是一系统，其包括：(a)一血液液体清除装置，其包括：(i)一入口，用于接收来自病人的血液，(ii)一出口，用于返回来自病人的血液，(iii)一中间装置，用于清除血液中的液体和污物，该中间装置设于所述入口和第一出口之间，以及(iv)一液体源，用于运输一液体，该液体选自透析液和置换液，其中，如果该液体是透析液，则所述液体源将该液体运输至所述中间装置，如果该液体是置换液，则在血液流出中间装置后，所述液体源将该液体运输至血液；(b)一浓缩液源，用于容纳一浓缩溶液，该浓缩溶液包含液体的一浓缩成分；(c)一浓缩液流量控制元件，用于控制浓缩溶液进入液体源的速度；(d)一第一传感器装置，用于监测病人的一心血管参数；以及(e)电子控制装置，其可操作地与所述传感器装置和所述浓缩液流量控制元件通信连接，其中该电子控制装置构造为根据从所述传感器装置获得的数据，通过该浓缩液流量控制元件来调节浓缩溶液进入液体源的速度。
第十八种情况是第十七种情况的一系统，其中所述电子控制装置置于所述血液液体清除装置内。
第十九种情况是第14-18种情况中任意一种的一系统，其还包括一计算机可读介质，其中该计算机可读介质包括指令，该指令使电子控制装置根据从传感器装置获得的数据来控制浓缩液流量控制元件，以调节浓缩溶液进入液体源的速度。
第二十种情况是，通过一血液液体清除装置或系统实施的一使用，其包括：(i)接收关于一监测到的心血管参数的数据至一血液液体清除装置或系统；以及(ii)根据接收到的关于监测到的心血管参数的数据中止一血液液体清除阶段。
第二十一种情况是第二十种情况的一使用，其中所述血液液体清除阶段在该阶段开始前中止。
至此，用于液体清除治疗的心血管监测的系统，装置和使用就均被描述了。本领域的技术人员将会认识到在不脱离本公开文本和后附的权利要求限定的精神和范围的情况下，本文所述的优选实施例是可以进行改变或修改的。

Claims (6)

1.一系统，其包括：
一血液液体清除装置，其包括：(i)一入口，用于接收来自病人的血液；(ii)一出口，用于返回来自病人的血液；(iii)一中间装置，用于清除血液中的液体和污物，该中间装置设于所述入口和出口之间；以及(iv)一控制元件，用于控制所述中间装置从血液中清除液体的速度；
一植入的传感器装置，用于监测病人的一心血管参数；以及
电子控制装置，其可操作地与所述传感器装置和所述控制元件通信连接；
其中该电子控制装置构造为基于从所述传感器装置获得的数据通过控制元件调节液体从血液中清除的速度，以及一浓缩溶液进入一液体源的速度，其中浓缩溶液含有磷酸盐、碳酸氢盐、氯、镁、钠、钾和钙的至少其中之一的浓缩物。
2.如权利要求1所述的系统，其中所述液体源用于运输一系统液体，该系统液体选自透析液和置换液的其中之一，其中，如果该系统液体是透析液，则所述液体源将该系统液体运输至所述中间装置，如果该系统液体是置换液，则在血液流出中间装置后，所述液体源将该系统液体运输至血液；其中所述系统还包括：
一浓缩液源，用于容纳所述浓缩溶液，该浓缩溶液包含系统液体的一浓缩成分；以及
一浓缩液流量控制元件，用于控制浓缩溶液进入液体源的速度；
其中所述传感器装置可操作地与电子控制装置耦合，并且所述电子控制装置进一步构造为根据从所述传感器装置获得的数据，通过所述浓缩液流量控制元件来调节浓缩溶液进入液体源的速度。
3.如权利要求1所述的系统，其中所述电子控制装置置于所述血液液体清除装置内。
4.一系统，其包括：
一血液液体清除装置，其包括：(i)一入口，用于接收来自病人的血液，(ii)一出口，用于返回来自病人的血液，(iii)一中间装置，用于清除血液中的液体和污物，该中间装置设于所述入口和出口之间，以及(iv)一液体源，用于运输一系统液体，该系统液体选自透析液和置换液的其中之一，其中，如果该系统液体是透析液，则所述液体源将该系统液体运输至所述中间装置，如果该系统液体是置换液，则在血液流出中间装置后，所述液体源将该系统液体运输至血液；
一浓缩液源，用于容纳一浓缩溶液，该浓缩溶液包含系统液体的一浓缩成分；
一浓缩液流量控制元件，用于控制浓缩溶液进入液体源的速度；
一第一传感器装置，用于监测病人的一心血管参数；以及
电子控制装置，其可操作地与所述传感器装置和所述浓缩液流量控制元件通信连接；
其中该电子控制装置构造为根据从所述传感器装置获得的数据，通过该浓缩液流量控制元件来调节浓缩溶液进入液体源的速度。
5.如权利要求4所述的系统，其中所述电子控制装置置于所述血液液体清除装置内。
6.如权利要求3所述的系统，其还包括一计算机可读介质，其中该计算机可读介质包括指令，该指令使电子控制装置根据从传感器装置获得的数据来控制浓缩液流量控制元件，以调节浓缩溶液进入液体源的速度。
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