CN103717243B - 肾病患者的液体量监测 - Google Patents
肾病患者的液体量监测 Download PDFInfo
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- CN103717243B CN103717243B CN201280020931.7A CN201280020931A CN103717243B CN 103717243 B CN103717243 B CN 103717243B CN 201280020931 A CN201280020931 A CN 201280020931A CN 103717243 B CN103717243 B CN 103717243B
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Abstract
一种使用,其包括开始一患者的一血液液体清除阶段;监测患者在血液液体清除阶段中组织液体量的一个指标,或部分组织液体量的一个指标;监测患者在血液液体清除阶段中的血液液体量的一个指标;确定组织液体量的指标与血液液体量的指标的一比值是否超出一预定范围;及若确定该比值超出所述预定范围,改变在血液液体清除阶段的液体清除的速率。一血液液体清除系统可以被构造为实现该使用。
Description
相关申请
本申请要求申请日为2012年3月20日,专利申请号为13/424,454的美国专利申请的优先权,该美国专利申请要求临时申请号为61/480,539,61/480,544,61/480,541,61/480,535,61/480,532,61/480,530及61/480,528的美国临时申请的优先权,所述各优先权临时申请的申请日均为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
本公开文本大致涉及用于监测肾病患者的液体量的装置、系统及使用,例如,接受血液透析和超滤以及需要监测血液液体量和组织液体量之间平衡的患者。
背景技术
血液透析和超滤都将过量液体的清除作为其一个主要目标。在治疗阶段前确定待清除的液体量,且其与患者治疗前的体重、在治疗期间的液体添加及患者理论上的干体重有关。清除的液体量和清除速率在透析机和过滤机上设定,并且以重量分析法来确认。
但是,很难准确地确定患者的干体重,干体重被认为是在人体肾脏正常工作时人的体重。某一患者在其肾脏正常工作时的体重往往是一未知的变量且会随着时间而变化。然而,患者干体重的准确确定对于一液体清除治疗(fluidremovalsession)的疗效是至关重要的。
遗憾的是,一般地,无法不断地计算或重新评估患者的干体重。不像患者的实际体重,其是在液体清除治疗之前和之后测得,通常确定干体重的频次更少;例如,每月一次,并且在确定一干体重和一给定液体清除治疗之间的时间内的干体重会变化很大,通常液体清除治疗一周三次。尽管作为液体清除考虑因素中的关键变量,但是通常很难计算干体重且有可能在治疗期间发生变化。
错误的液体清除量能在血液透析治疗时或血液透析治疗后导致严重的低血压和患者病危。猝死和心脏死亡(包括充血性心力衰竭,心肌梗塞和猝死)常见于血液透析患者中。请参阅刊登于1999年的第55卷的《国际肾脏期刊》的第1552-1559页,作者为布莱耶等人,名称为《血液透析患者中的猝死和心脏死亡率》的一文[Bleyeretal,"Suddenandcardiacdeathratedinhemodialysispatients,"KidneyInternational,(1999),55:1552-1559]。
为了更大程度地避免此类猝死,在血液透析阶段可以调节液体清除速率用于防止过快的清除或用于获得一具体的清除分布图。清除速率通过调节泵的参数来控制,且液体的清除量以重量分析来确认(即通过称重)。然而,现行的血液透析护理标准不包括任何用于获得实际液体状态的一准确读数的组织内液体量的监测。已经给出一些建议,即在透析中监测红细胞比容水平来监测血量,以试图避免潜在的液体失衡的可怕后果。然而,仅监测血液液体量并不能像监测血液量与组织量的比值,以及为了患者的安全确保在血液透析过程中该比值在预定的参数值内那样提供一个精确的图片。
发明内容
除了其他之外,本发明描述了在液体清除治疗中用于监测患者血液腔和组织腔内的液体量的装置、系统及使用,例如,血液透析、超滤等,并根据监测到的液体量来控制液体从血液中清除的速率。通过监测组织的液体量和血液液体量,可以调节在一血液净化阶段中从血液中清除液体的速率,以维持液体在血液和组织之间一种可接受的平衡(的状态),从而提升患者的安全性并提高血液清理的效率。
在本发明描述的各实施例中,一种使用,包括:(i)开始一患者的一血液液体清除治疗;(ii)监测患者在血液液体清除治疗中的组织液体量或部分组织液体量的一指标;(iii)监测患者在血液液体清除治疗中的血液液体量的一指标;(iv)确定组织液体量指标与血液液体量指标的比值是否超出一预定范围;及(v)若确定该比值超出预定范围,改变在血液液体清除治疗期间的液体清除速率。
在本发明描述的多个实施例中,一系统,包括一血液液体清除装置,该装置具有:(i)一用于接收患者血液的入口;(ii)一用于返回清除液体后的血液至患者(体内)的第一出口;(iii)一用于清除血液中液体的中间装置,所述中间装置设置于所述入口和所述第一出口之间;(iv)一液体清除速率控制器;及(v)一用于被清除的液体和污物流的第二出口。该系统还包括:(i)用于监测组织液体量指标的一第一传感器;(ii)用于监测血液液体量指标的一第二传感器;及(iii)一处理器,与用于监测组织液体量指标的传感器、所述用于监测血液液体量指标的传感器及所述液体流速清除控制器可操作地(通信)连接。所述处理器构造为根据从所述第一传感器和所述第二传感器获得的数据来调节液体清除的速率。
在此所描述的所述系统、装置和使用的一个或多个实施例较之现有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
这些附图融入并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。附图只用于举例说明本发明的实施例,并不构成对本发明的限制。
图1-图4为示意性框图,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5-图7为在患者血液腔和组织腔之间的液体流动的示意性框图,呈现的这些附图有助于理解这里描述的某些原理。
图8为一示意性框图,根据本发明记载的各实施例,显示了在患者的组织腔和血液腔与血液液体清除装置之间的血液流动(虚线箭头)和液体流动(实线箭头),同时也显示了监测液体的可能的位置。
图9为一传感器选定部件的示意性框图,该传感器用于监测关于管道(tubing)的血液液体量指标。
图10-图11为抗阻传感器的选定部件在患者体外(图10)及植入患者体内(图11)的示意性框图。
图12-图16为流程示意图,其根据这里描述的各实施例,显示了使用的整个流程。
图17-图18为示意性框图,根据本发明记载的各实施例,示出了可能采用的血液液体清除装置或系统的选定部件。
图19为显示了各传感器和电子控制装置之间交互的一示意性框图。
图20为显示了传感器的选定部件的一示意性框图。
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。
具体实施方式
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例。可以理解的是,在不脱离本发明的范围和精神的情况下,也可以想到并做出其它实施例。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,除非内容清楚地表示其他含义。
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。
如本文所用,“组织液体量”表示患者的组织或部位内的液体量(相对于细胞或固体),患者可以是整个身体。组织“液体”通常被称为间质液。在各实施例中,根据本发明记载的教导,监测一个或多个组织液体量、组织液体量的变化率等等。
如本文所用,“血液液体量”表示相对于血液中的细胞或固体,液体所占血液量的含量或百分比。在各实施例中,根据本发明记载的教导,监测一个或多个血液液体量、血液液体量的变化率等等。
如本文所用,“血液液体清除过程(process)”等,是指将液体从患者血液中清除并且血液返回至患者体内的过程。在多数实施例中,血液也被净化,即废物从血液中清除且干净的血液返回至患者体内。血液液体清除过程的实例包括超滤,血液过滤,血液透析,血液透析滤过或腹膜透析等。任一被指示进行血液液体清除的患者都可以从这里所描述的装置、系统和使用中受益。
如本文所用,“被指示进行血液液体清除治疗的患者”是指已经接受,正在接受或将要去接受至少一次血液液体清除过程的患者。通常,此类患者为液体超负荷患者,例如,心脏衰竭患者,慢性肾病患者或急性肾衰竭患者。通常这些患者为第三期至第五期的慢性肾病患者,或对利尿剂不反应或反应迟钝的患者等。
除了其他之外,本发明涉及了在一血液液体清除治疗过程中用于在(患者的)血液腔和组织腔之间维持一适宜的液体平衡的系统及使用。传感器用于监测组织液体量和血液液体量,并基本所获取的数据,调节在一血液液体清除治疗过程中液体清除的速率,以确保在两腔室间的一适宜的液体平衡,并同时优化治疗时间。
任何适于将液体,或液体和污物,从血液中清除的装置或系统都可以根据这里所介绍的教导来使用。这些装置或其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至图4示出了装置和系统的一些实施例的框图。如图1所示,血液可以从患者10(体内)流出且液体可以通过一血液液体清除装置100被清除,然后送回到患者(体内)。清除出的液体可以被转移。在某些实施例中,血液液体清除装置100或系统,或其部件是植入的,清除出的液体可以转移至患者膀胱。血液液体清除装置100的实施例是超滤和血液过滤装置,可以如图1所示运行。根据这里介绍的教导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,也可以采用腹膜透析,即透析液进入到腹膜腔内。图1所示的虚线在某些实施例中表示:(i)被清除的液体可能被重新引入或收集后被重新引入至患者的血液中,以避免、缓解或改善低血压症状,或者(ii)可以返回,通过血液净化装置100过滤。
通过某些此类装置,液体可以以过快的速率被清除。相应地并参阅图2,置换液可以被引入患者血液中。如图2所示,置换液可以在液体清除前添加到原始的血液中或在初次液体清除后并在回到患者心血管系统前添加到血液中。优选地,置换液在初次液体清除后进行添加。置换液或被清除的液体可以引入患者的血液中,以避免、缓解或改善低血压症状;例如,可以被这里所描述的系统所检测到。当然,以上就图1所讨论的以及如图2所示,被清除的液体可以返回,通过血液净化装置100过滤。
如图3所示的实施例,血液液体清除装置100可以采用透析液以协助从患者血液中清除污物,以及协助维持适当的pH值和电解质平衡。已用过的透析液和从血液中清除的液体可以被转移。在某些实施例中,特别在血液液体清除装置100或系统或其部件是可穿戴或可植入的实施例中,已用过的透析液和被清除的液体,或其中的部分可以被再生以生成新的透析液以在血液液体清除过程中再次使用。一用于透析液再生的系统为REDY系统,如刊登于1998年出版的《肾脏学》杂志第4卷的第275至278页,名称为《再生透析吸附剂系统》,作者为罗伯特,M的一文所描述的[Roberts,M,"Theregenerativedialysis(REDY)sorbentsystem,"Nephrology4:275-278,1998],可以采用该系统或简单修改后用于这里所描述的实施例中。以图3的实施例所示的方式操作的系统或装置包括血液透析和血液透析滤过系统。根据这里所介绍的教导采用此类装置及其部件的实例在本领域中是公知的。如需要或期望,可以将新的透析液,已用过的透析液或被清除的液体引入血液中;例如,以避免、缓解或改善低血压症状。再次,被清除的液体可以返回,通过血液净化装置100过滤。
如图4所示,在图3(所示)的血液液体清除装置100以过快的速率将液体从血液中清除的情况下,置换液可以在液体清除的上游或下游被引入患者的血液中。
不管所采用装置或血液液体清除过程,重要的是,控制液体清除的量和速率以避免被清除血液液体的患者(产生)严重的低血压、心脏衰竭或心脏猝死。同样重要的是,为了效率而控制液体清除的量和速率。也就是说,即使非常慢地清除液体通常更为安全,但是这样慢的清除可导致血液液体清除阶段持续相当长的时间。尽管这样慢的清除对于可穿戴或可植入的血液液体清除系统是可接受的,但是对于需要患者去医院的大型独立系统是不可接受的。通常患者的生活质量已经很低,可能(还要)在医院中经受更长的时间,这些时间对系统缓慢地从血液中清除液体是必需的。理想地,血液液体清除装置或系统通过控制液体清除的速率来平衡健康问题和效率问题。
当然,被清除液体的量对于维持患者健康而言也是一项重要的变量。如果液体清除过少,患者将负荷过量的液体直到下一次血液液体清除阶段或直到液体清除处方改变,这能导致心脏衰竭,高血压或其他疾病。如果液体清除过多,患者可能会经受低血压、病危,心脏猝死等。相应地,希望不仅以一可接受的速率,还要以一可接受的量从血液中清除液体。
现参阅图5至图7所示的在患者10的组织腔14和血液腔12中的液体量之间的关系。如图5所示,任意一个腔室中短缺的液体清除,在组织腔14和血液腔12之间达到液体流动和液体量的平衡(以箭头标出)。如图6至图7所示,通过一血液液体清除过程,例如,血液透析或超滤,将液体从血液腔内清除,会引起从组织腔14到血液腔12中的液体流动的转换。然而,如果自血液腔12的液体清除速率过快(见图6所示的粗箭头),则自组织腔的液体流动速率(见图6所示的粗箭头)可能不足以与血液腔12的液体流失的速率保持一致,这样会令患者的健康处于危险状态。从患者健康角度来说,可能需要一种在腔室之间的更适度的液体流失差(参阅如图7所示的实施例)。当然,如上所述,只要液体清除速率是安全的,希望最大化血液的液体清除速率以提高血液液体清除过程的效率,并减少患者接受液体清除治疗的时间。
在实施例中,可以使用增加透析液(如果使用的话)的渗透压从而增加血液的渗透压的药剂,来提高液体从患者的组织腔传输至血液腔的速率。也就是说,通过增加透析液中渗透压促进剂的浓度,液体可以以一更快的速率从血液中被清除。然而,如果渗透压促进剂也可以穿过透析膜,并且血液中的浓度增加,返回到患者体内的血液可能比从患者体内流出的血液具有一更高的渗透压。而且具有一更高的渗透压的血液将易于导致从组织至血液的更快的液体清除。用于透析液的渗透压促进剂的浓度在治疗过程中可以变化;例如,在(治疗)开始时浓度较高而在(治疗)结束时浓度较低。可采用的渗透压促进剂实例包括钠和葡萄糖。当然,其他的渗透压促进剂也是可以采用的。
为了提高患者的安全或(治疗的)效率,希望监测流出和进入组织室14和血液室12的液体量,并确定相关的流出量和流入量是否在一安全范围内。可以根据不同患者来确定或可以根据人口统计初始设置适合的组织液体量与血液液体量的比值。作为一般规则,每小时8~10%的血液量的下降速率能够马上引起血容量不足。因此,对于多数患者而言,从血液中液体清除的速率应被设定为小于每小时8~10%。当然,如果使用渗透压促进剂,例如钠,则可以采用更高的速率,以提高液体从组织至血液的传输速率。
根据通常的血液和通常的血液总量或干体重可在开始时考虑合适的组织液体量。干体重是基于患者的身高,体重,性别,身体成分或血压。在血液液体清除治疗中以及当诸如绞痛等不适发生时,通过监测血压可以确定干体重。组织液体量的监测指标值可以被设定成不超出在已确定的干体重下液体清除的一监测值。根据这些初始设置和监测指标,一适当的液体量比例可以基于液体从组织至血液的传输速率和方向。在任何情况下,一旦确定适当的液体清除速率,可以将监测到的组织液体量(或其指标)与监测到的血液液体量(或其指标)结合使用,以确保维持适当的比例。
现参阅图8,组织腔14、血液腔12的液体流出量或液体量,或通过血液液体清除装置100的液体损失可以被监测,以确保在血液液体清除治疗期间维持血液腔12和组织腔14中的适合的液体比例。可以采用一个或多个传感器200,210,220或诸如此类的装置,用于在一个或多个的这些位置监测液体流或液体量。例如,传感器200可用于监测组织液体量,传感器210可用于监测血液液体量,传感器220可用于监测从血液中转移的液体流或液体量。
在置换液被引入血液中以补偿从血液中清除的液体的情况下(参阅,例如图2和图4以及上述相关内容),可能希望监测加入该置换液后这一点的血液液体量。如虚线传感器210所示,送回至患者10体内的血液的血液液体量可被监测。当然,可能希望监测在血液液体离开患者体内和送回患者体内时的血液液体量。血液液体量的差异将决定从血液腔12(流出)的有效液体量。也就是说,当在血液液体送回至患者体内前向血液中加入一些液体时,在血液液体清除过程中从血液中清除的液体可能多于血液腔12的总液体损失。
在某些实施例中,传感器220可被用来确定从血液腔12(流出)的液体损失。从血液中提取的液体通过用过的透析液转移的情况下,(参阅,例如图3和图4以及上述相关内容),液体量的差值是:(i)已用过的透析液和清除的血液液体和(ii)被引入的用于确定液体提取量的新的透析液之间的差。同时,在确定从血液腔12清除多少液体时需要考虑在血液液体送回患者体内之前的液体添加量(参阅,例如图2和图4及上述相关内容)。
任何适合的传感器可以用于监测液体损失,液体损失率或液体量。通常,传感器间接地测量液体量,且由此直接地监测液体量的一个指标。例如,在某些实施例中,传感器210间接地监测红细胞比容(红细胞所占血量的比例)。可以采用任何适合的红细胞比容传感器,例如,来自于HEMAMETRICS公司的CRIF-LINE监测仪(参阅HEMAMETRICS公司,CRIT-LINE红细胞比容的准确性,2003年2月24日出版,卷1,技术指引第11号(修订版D))[HEMAMETRICS,CRIT-LINEhematocritaccuracy,Vol.1,TechnNoteNo.11(Rev.D)February24,2003]。一个健康的成年男性的通常的红细胞比容水平约在40%和54%之间,或约为48%,同时,一个健康的成年女性的通常的红细胞比容水平约在37%和47%之间,或约为42%。在一血液液体清除治疗前,肾病患者血液的液体量可能是高的,因此,红细胞比容水平可能会低于期望值。在血液液体清除治疗结束时,希望患者的红细胞比容水平是一个健康成人的红细胞比容水平的10%或5%的范围内。相应地,血液液体量将在一个普通的健康成人的血液液体量的10%或5%的范围内。
因此,红细胞比容水平,或红细胞比容水平的一近似值,或红细胞比容水平的一指标,可以用于监测血液液体量。在某些实施例中,血红蛋白水平被作为红细胞比容水平和血液液体量的一指标被监测,原因在于血红蛋白浓度通常是与红细胞浓度成比例的。任何适合的传感器可以用来测量血红蛋白浓度,如使用于脉冲血氧计中的传感器,其通过测量(人体对)红光和红外光的吸收以分别确定氧合血红蛋白和脱氧血红蛋白的浓度。传感器(其可包括相关联的光源(s))可以放置于任何适当的位置,如将血液从患者体内输送至血液液体清除装置的输血管的周围或将血液从血液液体清除装置输送至患者体内的输血管的周围中,或在血液液体清除装置内等。在某些实施例中,传感器210被植入患者体内,并设置在一血管周围用以测量血红蛋白水平,以及红细胞比容和血液液体水平。
通过实例并参照图9,图9示出了一传感器210和管子300的示意图,管子300可能为一血管。一具有适合的波长(红光或红外光)的光源213设置于管子300的一侧,以使得光穿过管子300打到检测器215上。如果管子300中存在较高浓度的血红蛋白,更多的光被吸收(更少的光打到检测器215上)。如果合适的话,一导线212将电源及其他电信号从传感器装置本体211传导至光源213,传感器装置本体211中可以包括电源和其他控制或检测电子设备。导线217将电信号从检测器215传送至传感器装置本体211内的部件。
无论传感器210的放置(位置),该传感器可以通过监测流过管子300(不论是血管或是与血液液体清除装置一起使用的管子)、具有已知的红细胞比容水平的血液流动来校正。已获取的数值可以存储于查找表中,用于一血液液体清除治疗期间的参考,或当传感器处于使用状态时的其他需要。在某些实施例中,血液液体量的变化速率可以通过比较光吸收的变化率来确定;例如,当液体从血液中清除时。
根据这里介绍的关于血液液体量监测的教导,提供上述关于血红蛋白检测的内容,作为一个如何使用已知的检测技术和部件的例子。可以理解的是,其他技术和部件可用于监测血液液体量。例如,总血蛋白浓度或总白蛋白的浓度和血压,单独或组合使用,可用于评估血容量。通过实例的方式,高血压与低红细胞比容或高血压与低血蛋白共同表明血液液体超负荷的可能性较高。可选择地或附加地,血粘度可用作血液液体量的一个指标,并且可通过压力或流量测得。
再次参阅图8,关于监测在患者10的组织腔14内的液体量,可以采用任何适合的传感器200。通过举例的方式,可以监测电流通过患者组织的阻抗作为组织中的液体量的一项指标。参阅图10-图11,阻抗传感器200(图10)可以是外置的(图10)或可植入的(图11)。当组织中的液体量上升时,阻抗下降。可以理解的是,也可以采用电容,介电常数和其他相似测量(方法),因为这些(参数)是与阻抗相关的。为了本发明公开的目的,监测组织的与抗阻相关的电性能(参数)被认为是属于监测“阻抗”的定义。
如图10所示,在两个电极203、205之间监测阻抗。电极203、205通过导线可操作地与控制和处理电子设备201耦合。电子设备201被构造为在电极203,205之间生成一电压差,(这样)可以测得电流和计算阻抗。该测量可以在直流电或交流电模式下进行。阻抗或相位角可能与组织液体量相关。根据这里所述的教导,可以采用适合的外部抗阻监测仪200及其部件在本领域中是公知的。
如图11所示的实施例,含有电子控制装置201的导电壳体作为电极205的参比电极。在组织中壳体和电极205之间监测阻抗。电极205通过导线207与电子控制装置210耦合。如图11所示,电子控制装置201被构造为与患者体外的一个设备无线(通讯)连接,目的是发送监测到的阻抗数。此类无线通讯(设备)也可与任意一种类型的可植入的传感器一起使用。
为了监测组织液体量而检测组织阻抗是有据可查的。一个充分研究过的系统的实例是美敦力公司(Medtronic,Inc.)的液体状态监测系统,其可以在这里使用或经修改后在这里使用。这一系统,或其他类似的系统,具有用于确定组织阻抗以及液体量的可接受范围的程序,在文献中有完善的记录。参见,如(i)刊登于期刊《临床监测和计算》(2010),第24卷第449页-451页,作者为Siegenthalar等人的文章,及(ii)刊登于《心脏病》,第99期(增刊):3G-L-G,2007年5月21日,作者为Wang,Am.J.的文章[(i)Siegenthalar,etal.JournalofClinicalMonitoringandComputing(2010):24:449-451,and(ii)Wang,Am.J.Cardiology,99(Suppl):3G-l-G,May21,2007]。可选择地或附加地,在一段适当的时间内监测组织阻抗以建立适合的基线,同时患者标识(patientmarkers)或医生输入信息可以用于指示患者是否液体过载或不足。由阻抗传感器获取的数据和在传感器数据获取时患者液体状态的输入数据可以用于建立适合的阻抗值范围。
在某些实施例中,一个以上的植入式阻抗传感器,如采用一个以上的液体状态监测系统。这些传感器可以被设置或放置用于监测不同组织的阻抗,同一组织不同区域的阻抗等。万一传感器发生故障或作为从另一个传感器获得的读数的核查时,重复的传感器会提供(数据)冗余。在某些情况下,由传感器检测到的组织液体的变化可能是由于其他情况而非慢性心脏衰竭或肾病。例如,增加的肺液可能源于肺炎。这种液体是不需要指示进行血液液体清除治疗的。通过设置一第二阻抗传感器用于监测,例如,腹部液体,在放置和设置为用于监测肺部液体量的传感器上可以设置一个检查。该传感器可被构造为与其他各或其他的设备(通信)连接,以确定传感器读数是否显著地不同。
根据这里所介绍的关于组织液体量监测的教导,提供上述关于阻抗监测的内容,作为一个如何使用已知的检测技术和部件的例子。可以理解的是,可以采用其他技术和部件用来监测组织液体量。例如,电解质浓度,如可以使用离子选择性电极在组织中测得钠,钾或钙,其浓度越高组织液体量越低。通过进一步的实例,压力传感器设置于组织内用来在测量液体量变化时的组织的扩张或收缩,应力和应变传感器用于测量组织的模量或应力-应变曲线,且可以用于与不同的组织液体量相关联,组织的应力松弛或蠕变分布图可被测得并与不同的液体量等相关联。又例如,间接组织液监测的另一个例子是肺噪声的测量(方法),其由于空气流动的阻抗而在液体过载时更为严重。
再次参阅图8,传感器220可以是一个流量传感器,重量传感器,或任何其他能够监测液体量或其指标的适合的传感器。可以采用一个或多个这样的传感器220用于协助确定在血液液体清除治疗中从血液中清除多少液体。其它用来确定液体量的适合方法,包括利用一计量泵或利用一个压力传感器和已知的管径来计算流量。
尽管在图8中示出的是分开的,可以理解的是,一个或多个传感器200,210,220或其部件,可置于单个壳体内,如包含传感器电子装置的一壳体或血液液体清除装置的一壳体。
现参阅图12-16,这里所采用的一些典型的使用作为流程图呈现,这些使用是关于监测血液液体量和组织液液体量的。可以理解的是,所示的各流程图用来突显在此所描述的使用的某些相关方面,尽管它们显示于不同的流程图,显示于同一流程图中的使用步骤可以容易地与另一个流程图中的步骤互换或加入于另一个流程图中的步骤中。
在图12所示的实施例中,开始一血液液体清除治疗500,监测组织液体量的指标510和血液液体量的指标520。当然,血液液体清除阶段基本上是连续的,特别是以可植入的血液液体清除装置。无论血液液体清除阶段是否持续一段确定的时间或不确定的时间,比较组织液体量与血液液体量的比值,并确定这一个比值是否超出预定的可接受的范围530。若确定该比值没有超出预定的范围,血液液体清除阶段以先前设定的血液液体清除的参数继续进行。若确定该比值超出预定范围,则改变从血液中清除液体的速率540。
例如,如果组织液体量与血液液体量的比值高于预定阈值时,可以降低液体清除的速率,也就是说,如果过多的液体从血液中流出,或如果液体清除的速率快于从组织中流出以填补血容量的液体的速率,组织液体量与血液液体量的比值会上升。如果该比值上升到超出预定可接受水平的程度时,可降低液体清除速率,以为液体从组织流入到血液多留些时间时间,并且使得血液腔和组织腔中的液体达到适当的平衡,避免不希望出现的液体失衡,其对患者健康会产生不良后果。
与此相反,如果组织液体量与血液液体量的比值低于预定阈值时,可以提高液体清除的速率。例如,为了实现效率,希望在组织腔和血液腔之间维持小的但安全的液体失衡以在一个安全且有效率的速率下清除过多的液体。尽管组织液体量与血液液体量的比值低不会导致患者的健康风险(前提是最终清除了足够的液体量),但是可能会不必要地延长患者接受血液液体清除过程的时间。因此,通过在一血液液体清除治疗阶段监测组织液体量和血液液体量,根据监测到的指标能够精确地控制液体清除的速率,以提高患者的安全性和血液液体清除过程的效率。
组织液体量与血液液体量的比值过低也可以表示在血液送回到患者体内前过多的置换液被添加到血液中。因此,可以降低置换液的添加速率(为了本发明的目的这有效地提升了液体清除的速率)。
组织液体量与血液液体量比值的一适当范围可以以任一适合的方式来确定。例如,可以以患者的干体重时的比值作为参考(值)。在通常情况下,血液约占身体体重的7%,总组织液体约占身体体重的60%(包括血液,细胞外和细胞内的液体)。因此,通常一个健康人的组织液体量与血液液体量的比值为53/7,或约为7.6(例如,在6~9的范围内的)。这可以作为达到组织液体量与血液液体量一个适合的比值的起点。可选择地或附加地,可以通过在治疗过程中的学习步骤获得该参考比例,且该参考比例取决于患者。通过学习步骤可以优化组织(液体)量与血液(液体)量的比值(或及其指标)的变化图形。当获得一优化图形时,其可被用来指导个性化的治疗,以在不同患者中达到更好的疗效。
在某些实施例中,采用观察血液和组织的变化率的学习算法或进化算法。变化率的差异可用来确定在组织腔和血液腔之间的液体交换的时间常量。当考虑组织腔和血液腔之间更慢传输的时候,该信息可以用于建立一个红细胞比容目标值(或其他的血液液体量的指标)作为一最终状态。这可以用来动态调节液体清除速率。由患者或医生输入信息建立临界值。初始校准可以是已知的或可利用其他信息,如体重或其他外部实验室输入信息。
现参阅图13,其显示了类似于图12所示的一使用。在图13中,该使用包括根据监测到的指标510计算组织液体量的值515,以及根据监测到的指标520计算血液液体量的值525。可以根据这些计算值530来确定组织液体量与血液液体量的比值,而并非如图12中所示的根据监测到的指标本身所获取的数值。在两者中的任一情况下,假如组织和血液液体量的指标能够预测流量,指标的不同被考虑其中,其结果基本上相同。
例如,如果组织液体量是由阻抗决定的,组织液体量的增加会导致阻抗的增加。然而,如果红细胞比容水平用于确定血液液体量,血液液体量的增加会导致红细胞比容的减少。因此,如果图12的实施例中比例的确定考虑到了红细胞比容的增加表明了血液液体量的减少(的因素),其最终结果与通过图13的使用获得的结果基本相同。换句话说,如果理解了且解释了阻抗与红细胞比容的比值的变化不同于组织液体量与血液液体量的比值的变化,图12和图13的使用将产生类似的结果,该结果是关于改变液体从血液中清除的速率。
如图14中所示,在这里所述的使用,在某些实施例中,除了所述比值外,为了患者的安全,可以单独使用监测到的组织液体量的指标510或血液液体量的指标520。如图14中所示,可以确定监测到的组织液体量或血液液体量的指标是否分别在预定的可接受的范围内590。例如,如果组织液体量或血液液体变得不可接受地低(即使两者的比值可能在可接受的范围之内)或太高,可以改变从血液中清除液体的速率540。通过举例的方式,如果组织液体量的指标值显示接近干体重的一液体量,可以降低从血液中清除液体的速率以允许在到达干体重的液体量前达到一个适合的组织液体量与血液液体量之比。因此,在某些实施例中,用于确定监测到的组织液体量的血液的指标是否超出预定范围的阈值可以根据组织液体量与血液的液体量的比值来变化。例如,如果组织与血液的液体量的比值高(表示液体从血液中清除的速率快),则组织液体量的下限(如接近于干体重)可高于当组织与血液的液体量的比值低时的组织液体量的下限(建议液体从血液中清除的速率更慢),以避免超出干体重的组织液体量。
也如图14所示的,发出一警示496,如一音频或可视警报,用以提醒患者或医疗服务提供者在组织中或血液中太高或太低的液体量会存在潜在的危及患者健康的状况。
现参阅图15,其显示了类似于图12所示的一使用。图15中的使用包括:在开始血液液体清除治疗500之前,获取组织液体量的一个指标的基线值498或获取血液液体量的一个指标的基线值499。可以使用一个或两个基准值用于确定血液液体清除治疗的液体清除的初始剂量或处方490。可以在血液液体清除治疗期间根据治疗期间的监测510,520来调节液体从血液中清除的速率540。
现参阅图16,其显示了类似于图12所示的一使用。在图16中的使用,与图15所示的使用类似,包括:在开始血液液体清除治疗500之前,获取组织液体量的一个指标的基线值498或获取血液液体量的一个指标的基线值499。如果这些值被确定为超出预定可接受的范围497,开始一血液液体清除治疗500。这一使用可以优先适用于血液液体清除装置和监测传感器被植入或正在连续操作或可以连续操作的情况,因为血液液体清除治疗可以自动启动。可选地或附加地,在图16中所示的使用可包括向患者或医疗服务提供者发出一警示496,表明建议一血液液体清除治疗。
在透析中,低血压是主要的并发症(25-60%)。通过这里所述的使用,(在此使用中)可包括实时血压传感器或其他血液量传感器,可以预测即将发生的血压变化或血压值,例如,在一前馈的基础上。相应地,根据血液液体清除治疗期间收集的数据可以调节液体清除的速率,以避免低血压的情况,其与现行的护理标准不同,现行的护理标准是只有(当患者或医疗服务提供者)看见这些问题时才开始调节液体清除速率。例如,如上所述,从一个患者的治疗过程中得知的干体重和优化后的组织与血液的液体量的比例,可以有助于这个预测治疗更为有效且实用。若必要或需要时,置换液,透析液或被清除的液体可以在血液送回患者体内前引入至血液中,以避免、减轻或改善低血压症状;例如,如以上对图1-图4所描述的。
如上所述的使用,如图12-图16所述和所示的使用,可以通过任何适合的血液液体清除装置或系统来应用,例如以上图1-图4图所述和所示的血液液体清除装置或系统。此外,可以采用任何适合的传感器及传感器的配置,位置或方向,比如以上图8-图11所述和所示的血液液体清除装置或系统用于实现这里所述的使用。在以下的图17-20中,其显示了血液液体清除装置100或系统的各种具体配置,以及传感器200,210,220。然而,可以理解的是,示出具体装置100和传感器200,210,220的相互作用是为了举例说明的目的,而且可采用其他装置和配置。
现参阅图17,其显示了血液液体清除装置100的选定部件的一示意性框图。在所示实施例中,该装置具有:一入口110,用于接收来自于患者的血液,一血液流量控制元件120,与入口110(通信)连接且被构造为控制血液流过中间装置130的速率,该中间装置用于从血液中清除液体和污物。该装置还包括一出口140,与中间装置130(通信)连接,用于将血液送回患者体内。在所示实施例中,中间装置130包括一半透膜135,例如一血液透析过滤器或血液透析滤过的过滤器,膜将中间装置的血液流动腔体与透析流动腔体分开。装置100具有一入口160,用于接收新的透析液。入口160与一透析流量控制元件170(通信)连接,该透析流量控制元件用于控制透析液引入中间装置130的透析流动腔体的速率。该装置还有一出口180,与中间装置130(通信)连接,用于将使用过的透析液和从血液中清除的液体转移至装置外。在所示实施例中,如必需或需要的话,该装置还包括一负压控制元件190,与中间装置部件130的透析液腔体(通信)连接。装置100还包括电子控制装置150,其可以包括一处理器等,处理器可操作地耦合到血液流量控制元件120、透析流量控制元件170和负压控制元件190,并被构造为控制血液流量控制元件120、透析流量控制元件170和负压控制元件190。
根据从监测血液液体量或组织液体量的传感器接收到的信息,电子控制装置150可以控制一个或多个血液流量控制元件120、透析流量控制元件170及负压控制元件190,用于调节液体从患者血液中清除的速率。例如,(通过血液流量控制元件120)改变血液穿过中间装置部件130的流速可以改变穿过膜的液体清除。(通过透析流量控制元件170)改变透析液穿过中间装置部件130的流量可以同样地改变穿过膜的液体清除。(通过负压控制元件190)在膜135的透析液腔体一侧施加负压,由于对流作用,负压可以引起更多的穿过膜的液体清除。可以理解的是,装置100并不需要具有图17所示的所有可控制元件120,170,190,来根据监测组织液体量和血液液体量的指标的传感器的数据有效地控制从血液中清除液体的速率。
任何适合的血液流量控制元件120可以用于控制流过膜部件130的血液流量。例如,可以采用一个速度可变或可调的泵。可选地或附加地,可以采用一系列的电子可控制阀,该阀与具有不同的流动阻力的流动路径相连通(在这种情况下,限流器优选地(设置于)中间装置部件130的下游)。透析流量控制元件170可包含类似部件或类似地构造为血液流量控制元件120。负压控制元件190可包括泵等。
现参阅图18,图18中编号与图17相同的部件指的是相同或类似的部件,装置100可以包括一液体管路,用于在血液送回至患者体内前向血液中添加置换液。装置100包括一个入口197,用于接收置换液,以及一置换液流量控制元件195,与入口(通信)连接并且被构造为控制置换液添加至血液的速率。电子控制装置150与置换液流量控制元件195可操作地耦合,并被构造为根据监测组织液体量和血液液体量的指标的传感器的数据来控制置换液流量控制元件195添加液体至血液的速率。通过控制液体流入血液的速率,从而控制从血液中液体有效清除的速率。
任何适合的置换液流量控制元件195可以用于控制在血液送回患者体内前置换液进入血液的流量。置换液流量控制元件195包含如以上图18所示的血液流量控制元件120类似的部件或类似的构造。
如以上所述并如图19所示,一个或多个传感装置200,210,220或传感部件可以与一血液液体清除装置100或系统的电子控制装置150(通信)连接。该(通信)连接可以是直接或间接的。也就是说,一检测器和适合的电子设备,如过滤器,模拟-数字转换器等,可以直接地通过导线与装置100的传感电子设备150耦合。可选地,一传感装置可以获取被监测数据并将其传输至装置的传感电子设备。在任何情况下,传感电子设备被构造为根据所感测到的信息来控制液体从血液中清除的速率,例如,如上所述。
在某些实施例中,一种计算机可读介质包含指令,该指令使得所述电子控制装置的处理器执行上述使用的,例如,以上在图12-图16中所述和所示的使用。计算机可读介质可以是非瞬时的(non-transitory)。(例如,存储于存储器内等)。
为了举例说明的目的,图20显示了一独立传感装置200的框图。所示传感装置为一阻抗传感器,但是关于这种传感器的讨论很容易适用于其他类型的传感器。所示传感器是可植入的且具有一个密封的导电壳体299以作为电极205的一对置电极。电极205通过导线207可操作地与阻抗检测及电压生成电路296耦合,导线通过一引线(未显示)进入壳体。电路296可操作地与电源297和电子控制装置295耦合,电子控制装置包括一处理器294和一用于存储感测到的数据和处理器指令的存储器293。电子控制装置也可操作地与电源297和遥测电路289耦合,电源可以是一个电池或类似物,遥测电路用于和本发明之外的一设备无线(通信)连接。在某些实施方式中,遥测电路允许传感器装置200直接向装配有合适的遥测电路的一血液液体清除装置或系统传输监测到的液体量指标的数据(未在图17-18中显示)。
当然,以根据这里介绍的教导,在数据被传送到血液液体清除装置或系统之前,传感装置可以与一个或多个中间设备(通信)连接,用于使用这些数据来控制液体从血液中清除的速率。
这里描述了使用、系统、设备、计算机可读介质等的各种情况,这些情况归纳如下。
在一第一种情况中,由一血液液体清除装置实施的一使用。该使用包括:(i)开始一患者的一血液液体清除阶段;(ⅱ)监测患者在血液液体清除阶段中组织液体量的一个指标,或部分组织液体量的一个指标;(ⅲ)监测患者在血液液体清除阶段中的血液液体量的一个指标;(iv)确定组织液体量的指标与血液液体量的指标的一比值是否超出一预定范围;及(iv)若确定该比值超出所述预定范围,改变在血液液体清除阶段的液体清除的速率。
第二种情况是第一种情况的一使用,其中所述预定范围是基于血液液体清除阶段开始之前所获得的组织液体量和血液液体量的指标的测量值。
第三种情况是第一种情况或第二情况的一使用,其中如果组织液体量的指标与血液液体量的指标的比值超出所述预定范围且表明超出组织液体量对血液液体量的一阈值,则降低液体清除速率。
第四种情况是第一至第三种情况中任意一种的一使用,其中如果组织液体量的指标与血液液体量的指标的比值超出所述预定范围且表明低于组织液体量对血液液体量的一阈值,则提高液体清除速率。
第五种情况是第一至第四种情况中任意一种的一使用,还包括在开始血液液体清除阶段前监测患者组织液体量或血液液体量的指标;以及根据在开始血液液体清除阶段前监测到的组织液体量或血液液体量的指标来设定血液液体清除阶段的一初始液体清除量处方。
第六种情况是第五种情况的一使用,其中在开始血液液体清除阶段前监测患者的组织液体量或血液液体量的指标包括长期监测组织液体量的指标。
第七种情况是第六种情况的一使用,还包括:(i)确定在开始血液液体清除阶段前监测到的组织液体量的指标或血液液体量的指标是否超出了一预定阈值;及(ii)若指标超出了所述阈值,安排血液液体清除阶段或作出一警示。
第八种情况是第一至第七种情况中任意一种的一使用,还包括:(i)确定组织液体量的指标是否超出一预定范围或确定血液液体量的指标是否超出一预定范围;及(ii)若确定组织液体量的指标或血液液体量的指标超出一预定范围,改变液体清除的速率。
第九种情况是第八种情况的一使用,其中根据组织液体量的指标与血液液体量的指标的比值来确定组织液体量的指标的预定范围或血液液体量的预定范围。
第十种情况是第八种或第九种情况的一使用,其中确定组织液体量的指标是否超出一预定范围。
第十一种情况是第一种至第十种情况中任意一种的一使用,其中所述组织液体量的指标是患者组织中的电流阻抗。
第十二种情况是第十一种情况的一使用,其中在与患者皮肤接触的两个电极之间测量所述阻抗。
第十三种情况是第一种至第十二种情况中任意一种的一使用,其中监测血液液体量的指标包括检测一红细胞比容水平或其一指标。
第十四种情况是第十三种情况的一使用,其中检测红细胞比容水平或其一指标包括测量氧合血红蛋白浓度。
第十五种情况是一使用,其包括:(i)开始一患者的一血液液体清除阶段;(ii)监测患者在血液液体清除阶段中的组织液体量的一个指标,或部分组织液体量的一个指标;(iii)根据监测到的组织液体量的指标计算表明组织液体量的一数值;(iv)监测患者在血液液体清除阶段中的血液液体量的一个指标;(v)根据监测到的血液液体量的指标计算表明血液液体量的一数值;(vi)确定组织液体量的数值与血液液体量的数值的一比值是否超出一预定范围;以及(vii)如果确定该比值超出所述预定范围,改变血液液体清除阶段的液体清除的速率。
第十六种情况是一系统,其包括:(a)一血液液体清除装置,其包括(i)一用于接收一患者的血液的入口;(ⅱ)一用于将患者血液送回的第一出口;(ⅲ)一用于从血液中清除液体和污物的中间装置,该中间装置设于所述入口和所述第一出口之间;(iv)一液体清除速率控制器;及(v)一用于清除出的液体流和污物流的第二出口;(b)一用于监测组织液体量的一个指标的第一传感器;(c)一用于监测血液液体量的一个指标的第二传感器;(d)电子控制装置,与用于监测组织液体量的一个指标的传感器、用于监测血液液体量的一个指标的传感器及液体清除速率控制器可操作(通信)连接;其中该电子控制装置构造为根据从第一传感器和第二传感器获取的数据来调节清除液体的速率。
第十七种情况是第十六种情况的一系统,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第一传感器和第二传感器所获取的数据来调节清除液体的速率。
第十八种情况是第十六种情况的一系统,其中计算机可读介质包括指令,该指令使电子控制装置(i)根据从所述第一传感器和所述第二传感器所获取的数据分别计算组织液体量的指标与血液液体量的指标的一比值;(ii)确定所计算的比值是否超出一预定范围;及(iii)如果确定该比值超出所述预定范围,改变液体清除的速率。
第十九种情况是第十六种情况的一系统,其中计算机可读介质包括指令,该指令使电子控制装置(i)根据从所述第一传感器所获取的数据计算表明组织液体量的一数值;(ii)根据从所述第二传感器所获取的数据计算表明血液液体量的一数值;(iii)确定组织液体量的数值与血液液体量的数值的一比值是否超出一预定范围;及(iv)如果确定该比值超出所述预定范围,改变液体清除的速率。
第二十种情况是第十六至第十九种情况中的任意一种的一系统,其中所述液体清除速率控制器包括一个或多个血液流量控制元件、一负压控制元件,一透析流量控制元件及一新液体流量控制元件。
第二十一种情况是第十六至第二十种情况中的任意一种的一系统,其中所述用于从血液中清除液体和污物的中间装置包括一滤膜。
第二十二种情况是第十六至第二十一种情况中的任意一种的一系统,其中所述第一传感器、所述第二传感器及所述电子控制装置的一个或多个元件容纳于所述血液液体清除装置内。
至此,用于肾病患者的液体量监测的系统、装置和使用均已被描述。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。
在后续的权利要求中,“第一”、“第二”、“第三”等是用来区别元件而不是用来列举元件或限定元件的顺序的。例如,一“第三”传感器不是暗示有三个传感器,而是区别于“第一”传感器。再进一步举例,一“第三”传感器并不必须是排在一“第一”传感器之后的。
Claims (6)
1.一种血液液体清除系统,其包括:
一血液液体清除装置,其特征在于,该血液液体清除装置包括:
(i)一用于接收血液的入口;
(ii)一用于将血液送回的第一出口;
(iii)一用于从血液中清除液体和污物的中间装置,该中间装置设于所述入口和所述第一出口之间;
(iv)一液体清除速率控制器;及
(v)一用于清除出的液体流和污物流的第二出口;
一用于监测组织液体量的一个指标的第一传感器;
一用于监测血液液体量的一个指标的第二传感器;
电子控制装置,其与所述用于监测组织液体量的一个指标的传感器、所述用于监测血液液体量的一个指标的传感器及所述液体清除速率控制器可操作地通信连接;其中该电子控制装置构造为根据从监测组织液体量的一个指标的所述第一传感器和监测血液液体量的一个指标的所述第二传感器获取的数据的比值来调节清除液体的速率。
2.如权利要求1所述的系统,其特征在于,其还包括一非瞬时的计算机可读介质,该计算机可读介质包括指令,该指令使电子控制装置(i)根据从所述第一传感器和所述第二传感器所获取的数据分别计算组织液体量的指标与血液液体量的指标的一比值;(ii)确定所计算的比值是否超出一预定范围;及(iii)如果确定该比值超出所述预定范围,改变液体清除的速率。
3.如权利要求1所述的系统,其特征在于,其还包括一非瞬时的计算机可读介质,该计算机可读介质包括指令,该指令使电子控制装置(i)根据从所述第一传感器所获取的数据计算表明组织液体量的一数值;(ii)根据从所述第二传感器所获取的数据计算表明血液液体量的一数值;(iii)确定组织液体量的数值与血液液体量的数值的一比值是否超出一预定范围;及(iv)如果确定该比值超出所述预定范围,改变液体清除的速率。
4.如权利要求1所述的系统,其特征在于,所述液体清除速率控制器包括一个或多个血液流量控制元件、一负压控制元件,一透析流量控制元件及一新液体流量控制元件。
5.如权利要求1所述的系统,其特征在于,所述用于从血液中清除液体和污物的中间装置包括一滤膜。
6.如权利要求1所述的系统,其特征在于,所述第一传感器、所述第二传感器及所述电子控制装置的一个或多个元件容纳于所述血液液体清除装置内。
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