CN103747819B - 血液液体清除的自适应系统 - Google Patents
血液液体清除的自适应系统 Download PDFInfo
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- CN103747819B CN103747819B CN201280022402.0A CN201280022402A CN103747819B CN 103747819 B CN103747819 B CN 103747819B CN 201280022402 A CN201280022402 A CN 201280022402A CN 103747819 B CN103747819 B CN 103747819B
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Abstract
用于监测患者参数和监测血液液体清除系统参数的使用包括识别引起患者参数的改善或患者参数的恶化的那些系统参数。通过比较患者先前对系统参数或系统参数的改变的反应,一血液液体清除系统可能可以避免后续采用会危害患者的参数,并且可能可以获知哪些参数在一血液液体清除阶段可能对治疗患者是效果最好的。
Description
相关申请
本申请要求申请日为2012年3月20日,申请号为13/424,533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
本公开文本大致涉及用于监测血液液体清除阶段(session)的患者和系统参数的装置、系统及使用。
背景技术
接受血液透析或从血液中清除液体的其它治疗的患者经常会死于心脏并发症。很多因素可能导致这种死亡,包括由于这些患者体内血液液体量增加而在心脏上施加的压力。液体浓度增加以及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。另外,在血液透析或其它液体清除治疗期间,液体量或血液的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患者的高发病率。
当患者到达一个需要进行常规血液液体清除治疗的值时,患者接受定期检查,以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,这些检查通常一个月进行一次。
尽管此类月度检查能够根据患者需求为定制的血液液体清除阶段(session)或多或少地提供评估,然而,理想的是,提供患者及血液液体清除阶段参数的一更为系统的评估,以实现一种更具患者特异性的治疗。
发明内容
除了其他的以外,本公开文本描述了用于监测患者参数和血液液体清除系统参数及识别引起患者参数的改善(效果更好)或患者参数的恶化(效果更差)的那些系统参数的装置、系统及使用。通过比较患者先前对系统参数和系统参数的改变的反应,一血液液体清除系统可能可以避免后续采用会危害患者的参数,并且可能可以获知哪些参数在一血液液体清除阶段可能对治疗患者是效果最好的。
在本文描述的各实施例中,一种使用包括:(i)以初始系统参数开始一血液液体清除阶段;(ii)获得关于一个或多个患者生理参数的一第一数据集;(iii)将所述第一数据集存储至一“最好的”或“迄今为止效果最好的”的数据集存储器中;(iv)将在一效果提高查找表格中的初始系统参数与所述第一数据集相关联;(v)调节血液液体清除阶段的至少一个参数,以得到调整过的系统参数(adjustingatleastoneparameterofthebloodfluidremovalsessiontoarriveatadjustedsystemparameters);(vi)在血液液体清除阶段的至少一个参数被调整后,获得关于一个或多个患者生理参数的一第二数据集;以及(vii)若所述第二数据集中的至少一值相较于所述第一数据集中的至少一值的相应值更接近目标值,则:用所述第二数据集替换在“迄今为止效果最好的”的数据集存储器中的所述第一数据集;在所述效果提高查找表格中存储关于第二数据集的数据;并将关于调整过的系统参数的数据与所述第二数据集相关联。
在实施例中,一种由一血液液体清除系统实施的一使用包括:(i)获得关于一个或多个患者生理参数以及距离上一个血液液体清除阶段的时间中的一个或多个的数据;(ii)获得关于一血液液体清除阶段的一个或多个的目标结果的数据;(iii)确定一个或多个目标结果的至少其中之一是否在存储于一查找表格中的至少一相应的在先目标结果的一预定范围内,其中,所述查找表格包括关于患者的一个或多个的在先血液液体清除阶段采用的系统参数的数据;(iv)确定采用在先血液液体清除阶段的系统参数是否实现了至少一个目标结果;(v)若确定该至少一个目标结果已经实现,则确定患者参数的至少其中之一或距离上一个血液液体清除阶段的时间是否在存储于所述查找表格中的至少一个相应参数的一预定范围内;及(vi)若确定至少一个患者参数或距离上一个血液液体清除阶段的时间在一预定范围内,则采用在先血液液体清除阶段使用的系统参数来开始一血液液体清除阶段。
在实施例中,一种由一血液液体清除系统实施的一使用包括:(i)采集关于一患者的第一数据,该数据包括一个或多个生理参数的数据及距离上一个血液液体清除阶段的时间;(ii)采集关于患者血液液体清除阶段使用的系统参数的第二数据;(iii)根据采集到的第一和第二数据,判断系统参数的采用是否改善了患者的至少一个生理参数;(iv)确定当前患者数据的一值是否在采集到的第一数据的一相应值的一预定范围内;及(v)若确定这些参数存在且若确定当前患者数据在所述预定范围内,则采用引起改善的系统参数。
在本文中所描述的用于实施上述使用的血液液体清除系统也可以表现为计算机可读介质,其被执行时,使得一血液液体清除系统实施本文所述的使用。
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用于患者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
这些附图被纳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。附图只用于解释本发明的实施例,并不构成对本发明的限制。
图1-图7为流程图,其根据本文所描述的各实施例来解释使用。
图8为用于解释本发明的图形示意图,其显示了监测到的数据(非实际数据)。
图9为流程图,其显示了本文所描述的一使用的一实施例。
图10-图12为示意框图,其显示了血液液体清除装置和一患者之间的交互作用,其显示了血液流动(虚线箭头)和液体流动(实线箭头),该血液液体清除装置可用于本文所描述的各实施例中。
图13为示意框图,其显示了流动路径以及一些控制装置,这些控制装置用来控制浓缩液流入血液液体清除治疗使用的液体的流动。
图14-图15为血液液体清除装置中一些部件的示意框图,该血液液体清除装置被设置为各种系统参数。
这里所呈现的示意图并不是必须按比例的。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,在一特定的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方式。可以理解的是,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。
本文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,除非本文清楚地指出了其他含义。
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,除非本文清楚地指出了其他含义。
如本文所用到的“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。
如本文所用到的“血液液体清除治疗(bloodfluidremovalprocess)”或类似语是指一个从患者的血液里将液体清除再将血液返回到患者体内的过程。在大多数情况下,血液也被净化,即从血液中清除废物,被净化的血液返回到患者体内。血液液体清除治疗的实例包括超滤、血液过滤、血液透析、血液透析滤过、腹膜透析等等。任何需要进行血液液体清除的患者都可以从这里所描述的装置、系统以及使用中受益。
如本文所用到的“有效的”等,由于其与患者参数有关,因此其是指一个或多个患者参数离该一个或多个参数的一个或多个目标有多近。因此,一迄今为止“效果最好的”患者参数是在一给定时间的一患者参数,其比在任意之前时间测得的相同参数都要更接近目标。一“效果更好的”的患者参数是在一给定时间测得的一参数,其比在另一时间测得的相同参数更接近目标。一迄今为止“效果最差的”患者参数是在一给定时间的一患者参数,其较之在任何之前时间测得的相同参数更远离目标。一“效果更差的”患者参数是在一给定时间测量或观测到的一患者参数,其较之在另一时间测得的相同参数更远离目标。
除其他以外,本文描述了用于监测患者生理参数和血液液体清除系统参数以及识别这些导致生理参数改善(或更有效果)或恶化的系统参数的装置、系统和使用。通过比较患者对系统参数或系统参数改变的过去反应,一血液液体清除系统可以避免会对患者造成损害的参数的后续使用,并且还可以获知哪些参数对于治疗血液液体清除阶段的患者可能是最有效果的。
参阅图1,其示出了本案实施例的一高度概括的示意概览。如图1所示,采用一学习算法520根据输入确定什么系统参数效果好,以产生期望的患者生理结果。任何合适的输入变量500都可以由算法520在学习过程中进行考虑。例如,可以输入诸如自患者上一次血液液体清除阶段起多长时间的变量。此类输入可能是重要的,因为例如正以周一,周三,周五计划安排接受血液透析的患者,最有可能在周一的血液液体清除阶段之前、期间或之后,就遭受不利的心脏病。因此,当患者在72小时内没有接受一个治疗阶段时,算法520可以考虑相对于患者在48小时内没有接受一个治疗阶段,是否应当采用一组不同的系统参数。输入变量500也可以包括患者是否在限定的时间内接受一血液液体清除治疗阶段。算法520可以根据患者对快速液体清除速度的反应历史,确定是否应采用一更快的液体清除速度,或者确定是否在一部分阶段采用一减缓的液体清除速度可能效果最好。可替代地,患者可以有额外的时间来进行一血液液体清除阶段,且算法520可以将此类输入500纳入考虑,以根据患者历史,确定减缓液体清除速度或减缓一电解质浓度的调整是否有利。当然,可以理解的是,其他任何关于目标结果(例如,快速阶段,长期阶段等)、患者历史(如从上一个阶段起的时间)等合适的输入变量500都是可以输入的。在实施例中,考虑到后续患者的行为或需要的输入可以被输入到系统中。例如,如果一患者知道其将错过一个阶段或者知道距离其下一阶段的时间由正常被延迟,那么距离下一阶段的时间可以被输入,其可能会影响系统参数(例如,可能清除额外的液体等)。以另一个例子举例来说,如果患者知道其在治疗阶段之前将会吃掉或喝掉比最佳量更多的量,那么可以在系统中输入预期的消耗水平。
如图1所示,根据输入变量500以及患者的生理变量510,算法520可以根据在该算法下的血液液体清除阶段的患者历史,确定采用合适的系统变量530。在一血液液体清除阶段中,系统变量530可能发生改变,且对改变的系统变量做出反应的患者生理反应可以被监测。如果患者生理变量510中的一个或多个有改善或者变为“效果更好的”,那么算法520可以将改变的系统变量530和效果提高的患者结果联系起来,这样当患者具有一组类似的生理变量510时,改变的系统变量530就可以用于阶段的后期或一后续的阶段中。如果患者的生理变量510中的一个或多个恶化了,那么算法520可以将改变的系统变量530与一效果更差的患者结果联系起来,这样当患者具有一组类似的生理变量510时,就可以避免在阶段的后期或一后续的阶段中使用改变的系统变量530。
在实施例中,通过传感器装置监测生理变量510,该传感器装置将关于变量的数据直接传送至算法520内或运行算法的电子元件。该传感器装置可以监测患者血液中的液体量、患者组织中的液体量、患者血液中的电解质浓度、患者血液的pH值、患者心血管参数的一个或多个,例如血压,心律,心率或其组合(combinations)或这些参数的指标。该传感器装置可以在血液液体清除阶段之前、期间或之后监测患者生理参数。
可以采用任何合适的传感器装置。关于血液液体量和组织液体量的传感器装置和系统的实例在美国临时申请号为61/480,528,申请日为2011年4月29日,名称为“肾病患者的液体量监测”,代理人案卷号为P0041416.00的临时申请专利中有介绍,且在美国临时申请号为61/480,530,申请日为2011年4月29日,名称为“监测肾病患者的液体量”,代理人案卷号为P0041417.00的临时申请专利中也有介绍;这两个临时专利申请以其各自与本案公开的内容不相矛盾的部分在此全部引用纳入本案。用于监测组织液体量、血液液体量、从血液中转移出的液体的流动或从血液中转移出的液体量等的传感器装置通常间接监测液体,并直接监测液体量、液体流动等的一指标。例如,一可以间接地监测红细胞比容(血液量中红细胞所占的比例)传感器装置。任何适宜的红细胞比容传感器装置,例如HEMAMETRICS公司的CRIT–LINE监测器(参见HEMAMETRICS,CRIT–LINE红细胞比容的准确性,卷1,技术指引No.11(修订版D),2003年2月24日)[HEMAMETRICS,CRIT-LINEhematocritaccuracy,Vol.1,TechnNoteNo.11(Rev.D)February24,2003)]均可被使用,并且可以作为血液液体量的一指示器。一构造为监测血红蛋白水平的传感器装置也可以作为血液液体量的一指示器使用,因为血红蛋白浓度通常与红细胞浓度是成比例的。因此,较低的血红蛋白浓度可能表征着较高的血液液体量。任何合适的传感器装置均可被用来测量血红蛋白浓度,例如用于脉搏血氧计的传感器装置,脉搏血氧计通过测量吸收的红光和红外光来分别确定氧合血红蛋白和脱氧血红蛋白的浓度。该传感器装置(可包括相关联的光源)可设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,或在血液液体清除装置内等。另外地或可替代地,一传感器装置可被植入患者体内,并设置在血管附近以测量血红蛋白水平以及由此的红细胞比容和血液液体水平。进一步举例来说,总血蛋白或白蛋白浓度,以及血压,其中一个或其组合可用于评估血容量(bloodvolume)。高血压结合低红细胞比容或低血蛋白可能表征着血液液体过多的可能性较高。可替代地或另外地,血粘度可以被用作血液液体量的一个指标,且可通过测量压力或流速得到。可以采用阻抗、电容或介电常数传感器装置监测液体量。例如,可以监测两个电极之间的阻抗。该电极可以可操作地与电子控制装置和处理装置通过导线连接。该电子元件构造为在电极之间产生一电压差,电流可以被测量,并计算出阻抗。测量可以在直流或交流模式下进行。阻抗或相位角可能与组织液体量相关。为了监测组织液体量而感测组织阻抗已有详细记载。一个充分研究过的系统的实例是美敦力公司(Medtronic,Inc.)的OptiVol液体状态监测系统,其可以用于本案或经调整后用于本案。这一系统,或其他类似的系统,具有详尽记载的用于确定组织阻抗以及由此的液体量的可接受范围的程序。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-1-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]。可替代地或另外地,可在一段适当的时间内监测组织的阻抗以建立合适的基线,且患者标记(patientmarkers)或临床医生的输入也可用于指示患者的液体是过多还是不足。从阻抗传感器装置获得的数据以及输入数据可用于建立阻抗值的合适范围,该输入数据是关于在获得传感器装置数据时患者液体状态的。
用于监测pH值和电解质浓度的传感器装置和系统的实例公开于美国临时申请号为61/480,532,申请日为2011年4月29日,名称为“液体清除治疗的电解质和pH值监测”,代理人案卷号为P0041418.00的美国临时专利申请中,该专利申请与本案公开的内容不相矛盾的部分在此全部引用纳入本案。当然,任意合适的用于监测pH值和电解质浓度的传感器装置或系统均可被采用。例如,可以采用一传感器(transducer)检测pH值或电解质。合适的传感器可以包括一离子选择性电极,其构造为检测H+离子、K+离子、Na+离子、Ca2+离子、Cl-离子、磷酸盐离子、镁离子、醋酸盐离子、氨基酸离子等。此类电极以及采用此类电极的传感器装置的部件在本领域内是公知的,并可用于或调整后用于本文所述的监测中。可以采用一个或多个传感器装置检测一种或多种离子,以测量血液中的pH值或电解质。在一些实施例中,一个传感器装置可以具有一个以上的传感器,即使是无线的,也可以监测一种以上的离子种类。通过测量多种离子种类,可以对各电解质的水平或血液成分有更详细的了解。例如,某些患者在某种情况下,一种电解质可能处于升高的水平,而另一种可能处于下降的水平。在一些实施例中,采用一个以上的传感器装置测量同一种离子,是为了达到确认和重复测量的结果,这能够提高可靠性和准确性。在一些实施例中,用于同一种离子的传感器装置可以构造为准确地测量离子浓度的不同范围。在实施例中,一个以上的传感器出现在一个单元中。这方便了数据采集和电路设计,因为可以在一个地方同时采集所有的数据。进一步地,多个传感器可以共享同一液体收集装置(例如,在植入病例中的一微量透析仪),并且如果有需要或有要求的话,可以共享同一数据处理和存储部件。为了监测电解质或pH值,一检测pH值或电解质浓度等的传感器装置(或传感器)可以放置在任意合适的位置。例如,传感器装置可以植入患者体内,可以设于患者体外一血液液体清除装置的上游,或可以设于患者体外一血液液体清除装置的下游等。
用于监测心血管参数的传感器装置和系统的实例公开于美国临时申请号为61/480,535,申请日为2011年4月29日,名称为“液体清除治疗的心血管监测”,代理人案卷号为P0041857.00的美国临时专利申请中,该申请与本案公开的内容不相矛盾的部分在此全部引用纳入本案。当然,任何合适的用于监测心血管参数的传感器装置均可被采用。在实施例中,pH值或电解质传感器装置,例如如上文所述的,可以用于监测心血管参数。可以采用监测心率或心律的传感器装置。一种构造为监测患者的ECG信号的适宜的可植入的传感器装置是美敦力公司的Reveal系列的可植入式心脏监视器(Medtronic,Inc.’sRevealseriesinsertablecardiacmonitor)。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。(prescription)。可以采用血压监测器,其可以是外置的或可植入的(例如美敦力公司的主动式无线压力传感器(activeleadlesspressuresensor,ALPS)),其通常以一支架的形式将所述装置固定在血管内。这样一种装置可以设置在任何合适的血管内,例如在一股动脉内或在一肺动脉内。一可穿戴的传感器系统,例如霍尔特传感器系统(Holtersensorsystem),可以用于监测患者的ECG活动。无论采用的传感器装置或传感器系统或其部件是否是可植入的,可穿戴的,一大型独立装置的一部分,或一血液液体监测装置的一部分,该传感器装置都可以监测到一患者的任何适当的心血管参数。在各实施例中,传感器装置或监测系统构造为监测心率、心律或其变量,或者血压中的一个或多个。可被测量的心律变量的实例有心率变异性(HRV)、心率震荡(HRT)、T波电交替(TWA)、P波离散度、T波离散度、Q-T期间、室性早搏(VPD)等等。
如上所表明的,用于监测患者生理参数的传感器装置可以是可植入的或可穿戴的,或者其具有的部件是可植入的或可穿戴的。在实施例中,多个传感器装置可以通过遥测技术、车身总线等连接。这些连接的传感器装置可以是相同或不同类型的(例如,pH值或阻抗)。这类连接的传感器装置是为了在患者身体的不同位置进行监测而设置的(例如体内或体外)。
监测可以在一个血液清除阶段期间进行,或在各血液清除阶段之间进行。在实施例中,血液液体清除是长期进行的,例如当一血液液体清除装置或其一部件是可穿戴的或可植入的时,监测就是长期进行的。与血液液体清除相关的长期监测在美国临时申请号为61/480,544,申请日为2011年4月29日,名称为“pH值或电解质的长期监测”,代理人案卷号为P0041857.00的美国临时专利申请中有描述,该申请与本案公开的内容不相矛盾的部分在此全部引用纳入本案。
可替代地或另外地,监测可以包括接收患者或医生关于患者状况的反馈。例如,患者可以指出开始痉挛(其常常发生于当过多的液体被清除时)的时间点。血液液体监测装置可以包括一输入装置,例如用于输入这些数据的一键盘或触屏显示器。可替代地,一分离的装置,诸如一患者编程器、笔记本电脑、平板电脑、个人数据辅助设备、智能手机等,都可以用于输入数据等。
任何合适的系统变量530都是可以被调整的。图10-15以及与其相关的下文描述了一些合适的血液液体清除系统以及可被调整的变量。在很多情况下,液体清除速度、血液流动速度,或置换液或透析液中的电解质浓度或pH缓冲液的成分均是可以调整的。期望通过监测血液液体清除系统的参数来确保该系统以一预期的方式运行。例如,期望通过对液体清除速度进行监测而不仅仅是通过调整与液体清除速度相关的一系统变量,来确保调整过的系统变量以预期的方式实际调整液体清除速度。可以采用任何合适的系统和使用来监测此类系统的运行。用于监测系统运行的系统和使用的实例在美国临时申请号为61/480,541,申请日为2011年4月29日,名称为“血液液体清除系统运行监测”,代理人案卷号为P0041858.00的临时专利申请中有描述,该申请与本案公开的内容不相矛盾的部分在此全部引用纳入本案。例如,可以采用设于血液液体清除装置的上游或下游的流量传感器装置,诸如一声波多普勒测速仪、一光学流量计、一热流量计、一文丘里流量计、一液体内桨式流量计等来监测系统的运行。构造为监测血液中或从血液中清除出的液体中的一化合物的一指标的传感器装置可以用来监测系统的运行。该传感器装置可以构造为监测血液的成分,该血液被设置为在某些血液液体清除过程中被清除,例如在血液透析中。上述化合物的实例包括尿素、肌酸酐、硫酸盐、磷酸盐、β-2-微球蛋白等。能够测量此类化合物的传感器装置在本领域内是公知的,且可以经简单调整后用于本案。例如,诺瓦公司(NovaBiomedical)生产的各种能够检测血液成分(例如肌酸酐、磷酸盐、尿素等)的传感器装置,该传感器装置可以用于本案或经调整后用于本案。可以用于本案或经过调整后可以用于本案的其他尿素传感器检测技术在作者为Zhong等人的,《临床生物技术期刊》,1992;8(l):57-65中有描述(Zhongetal.,Clin.J.Biotechnol.1992;8(l):57-65)。可以用于本案或经调整后可以用于本案的β-2-微球蛋白传感器检测技术在作者为Brynda等人的,《生物传感器与生物电化学》,1999;14(4):363-8(Bryndaetal.,BiosensBioelectron.1999;14(4):363-8)以及作者为Nedelkov等人的,《蛋白质组学》,2002;2(4):441-6(Nedelkovetal,Proteomics.2002;2(4):441-6)中有描述。当然,可以采用任何合适的传感器技术。进一步举例来说,可以采用压力传感器装置来监测穿过一血液液体清除膜的压力差,以监测系统的运行。
现参阅图2,其示出了一使用的一高度概括的流程图。该使用包括提供输入600,例如向一血液液体清除系统输入与图1相关的上文所述的变量。该使用还包括启动或开始一血液液体清除阶段700,并从该阶段中学习800。该学习800可以是如上文与图1相关的描述所描述的,采用被改变的系统参数和被监测的患者生理参数来确定哪个系统参数的调整会产生想要的患者生理结果。
举例并参照图3,其显示了发生于一血液液体清除阶段期间的一学习过程的一实施例的更多细节。开始该血液液体清除阶段700,以及监测患者810。存储监测到的患者参数(例如上文所述的患者生理变量)820,例如存储于血液液体清除系统的存储器中。调整该系统参数(例如上文所述的系统变量)830并存储该系统参数840,例如,存储到血液液体清除系统的存储器中,该系统参数可以包括从血液中清除液体的速度或一透析液或置换液的电解质浓度;并且继续监测患者810。将该组已经存储的患者参数820与一组已经存储的系统参数840相关联850,以使系统可以回忆起某一系统参数,该某一系统参数在患者具有一组给定的参数时被采用。关于存储的患者参数820和存储的系统参数840的数据可以采用例如一时间事件进行标记,以将两组数据进行关联。当然,可以采用任何其他合适的用于关联该数据集的使用或装置。在一些实施例中,该被关联的数据或其一部分被置于一查找表格中,该查找表格860对改变系统参数的患者生理反应的历史进行跟踪。
图4显示了一更详细的实施例。在图4所示的实施例中,在一血液液体清除阶段期间对患者进行监测810。希望能够确定从对患者进行的监测获得的数据是否超出了范围813。如本文所用的,“超出范围”是指一监测到的参数的一值超出了(例如,低于或高于)一预定的范围值。该预定的范围值可以表征一患者的安全性。如果数据超出了范围,那么就可以发出一警报815,或是停止该阶段817。在某些情况下,可能希望继续进行该阶段,即使该监测到的数据或其某些方面已经超出了范围。在所示的实施例中,如果该阶段继续进行,(例如,出于选择或是由于监测到的数据没有超出范围),关于监测到的患者参数的数据就会被存储820,并与先前获得的(例如,在一先前的阶段中或该阶段的早期)、已经存储的患者数据进行比较。可以做出判断是否当前患者参数数据较之由系统参数调整830引起的已存储的患者参数数据的效果更差,该系统参数的调整830发生在系统参数当前设定之前。如果确定该数据效果更差823,那么已存储的当前患者参数820可以与已存储的当前系统参数840相关联,例如如上文所述的。在某些情况下,可能希望,例如通过将当前患者数据与一采集到的患者数据历史进行比较,来确定当前患者参数数据或其一部分或其一方面是否是效果最差的825,其已在一当前或先前的血液液体清除阶段中在患者体内被检测到。如果当前患者数据是迄今为止观测到的效果最差的825,则已存储的当前患者参数820可以与已存储的当前系统参数840相关联851。这样,只有“效果最差的”患者状态被跟踪,不同于跟踪全部患者状态,其可以节约存储空间和处理能力。在任何情况下,一旦患者和系统参数数据相关联851,该系统参数就可以被调整830,并且该过程可以重复。
如果确定当前患者参数数据较之由系统参数调整(其就发生在系统参数当前设定之前)而引起的已存储的患者参数数据没有效果更差,那么就做出当前患者参数数据较之由系统参数调整830(其就发生在系统参数当前设定之前)而引起的已存储的患者参数数据是否效果更好的判断833。如果该数据被判断为效果更好833,那么已存储的当前患者参数820就可以与已存储的当前系统参数840相关联852,例如如上文所述的。在某些情况下,可能希望通过例如将当前患者数据与一采集到的患者数据历史(例如,图3中的历史表格)进行比较,来确定当前患者参数数据或其一部分或其一方面是否是效果最好的835,其已在一当前或先前的血液液体清除阶段中在患者体内被检测到。如果当前患者数据是迄今为止观测到的效果最好的835,那么已存储的当前患者参数820就可以与已存储的当前系统参数840相关联852。这样,只有“最佳”或效果最好的患者状态被跟踪,不同于跟踪全部患者状态,其可以节约存储空间和处理能力。在任何情况下,一旦患者和系统参数数据相关联852,该系统参数830就可以被调整,并且该过程可以重复。
现参阅图5,其显示了一种使用的一个实施例,在该使用中一个以上的患者参数变量被评估,采用的方式和与图4相关的描述类似。在图5所示的实施例中,评估两个患者参数变量。然而,可以理解的是,任何数量的患者参数变量均可以采用如图5所示的使用或者其他任何合适的使用来评估。在图5所示的实施例中,变量被标记为“首要的”和“次要的”,因为希望将患者参数变量按优先次序区分。例如,在某些情况下,可能希望监测血压并试图在整个阶段获得一在一目标范围或一目标范围附近的稳定血压,因为低血压是血液液体清除阶段中最常见的副作用的之一。也就是说,只要其他患者参数没有超出一预定的范围,该系统就可以试图保持血压受到控制,并为了该目的而进行调整。然而,在某些情况下,减少心律失常是首要目的,因为很多需要接受血液液体清除治疗的患者死于由于心律失常的并发症。如果将心律失常确定为首要的患者参数,那么血液液体清除系统就可以试图保持心律失常受到控制,并为了这一效果进行调整,而不再考虑其他患者参数,例如,只要其他患者参数维持在可接受的限度内。
图5所示的使用包括监测患者参数810(至少一首要的患者参数和次要的患者参数),存储患者参数数据820,并确定一参数或其一方面是否超出了一预定的范围813。如果该参数超出了范围,则可以发出一警报815,血液液体清除阶段可以停止817或可以继续进行。如果确定该参数没有超出范围813,则该系统参数可以被调整843并存储840。然后可以通过例如将当前患者参数数据与由系统参数调整(其就发生在系统参数当前设定之前)而引起的已经存储的患者参数数据进行比较,来做出该首要的患者参数是否效果更差的判断843。如果该首要的患者参数被判断为效果更差843,那么当前存储的患者参数数据可以与当前存储的系统参数相关联。可替代地或另外地,可以做出与该首要的参数相关的当前患者参数数据是否是效果最差的判断845,其已经在一当前或先前的血液液体清除阶段中在患者体内被检测到,例如如上文关于图4的描述。如果是效果最差,那么可以将当前存储的患者参数数据与当前存储的系统参数数据相关联853,如上文关于图4的描述。可以做出类似地关于首要的患者参数数据是否是效果更好的853或迄今为止效果最好的855判断,并且可以将已存储的系统参数和患者参数相关联854。可以做出类似地关于次要的患者参数或与其相关的一值是否是效果更差的863,效果最差的865,效果更好的873,效果最好的875判断,并且可以做出恰当的关联855,856。这样,该系统可以识别并学习系统参数如何可以单独地影响被监测的患者参数,例如血压、心率,液体量和电解质浓度。根据这些信息,系统可以选择采用哪种系统参数以产生可能对患者有利的结果。
现参阅图6,其为一流程图,其显示了两个或更多的患者参数对系统参数的变化830的组合反应被跟踪的过程。为了方便,以上关于图4和图5中所示以及所描述的部分步骤在图6中被省略了。然而,可以理解的是,可以采用关于在图6中所示的使用中相同的或类似的步骤。在所示的实施例中,患者参数和系统参数只有在首要的和次要的患者参数被确定为变得效果更差843,863或效果更好的853,873的情况下,才被存储857,858。这样,系统可以识别或学习哪种系统参数会导致多个患者参数发生期望的(或不期望的)改变。
通过如图3-图6所示的以及如上文所述的患者参数数据与系统参数数据的关联,可以获得患者对于系统参数变化的反应历史。该历史可以是一个或多个查找表格的形式,该历史可以在一血液液体清除阶段之前或期间被查询,以确定在一给定时间点的给定患者生理参数,哪种系统参数更有可能使得患者产生积极的反应,以及哪种系统参数更有可能使得患者产生消极的反应。因此,系统可以通过调整参数来对那些更可能使得患者产生积极反应的参数做出反应。
举例并参阅图7,其为一流程图,其显示了如何使用已存储和相关联的数据(例如,如上文关于图3-图6所描述的)来确定在一血液液体清除阶段的一给定的时间采用哪种系统参数的图示和实施例。该使用包括启动或开始一血液液体清除阶段700,监测患者810,查询历史查找表格880,该历史查找表格可以通过如上文关于图3-图6所述的将系统参数和患者参数相关联而生成。将与当前患者参数数据关联的一值和与查找表格中一相应值相关的数据进行比较,并确定当前患者参数是否与存储于历史表格中的先前患者参数相似882。举例来说,可以确定一当前患者参数数据集的值与查找表格中的一相应值相似,如果值的偏差在10%以内。如果有一个以上的相应值在被认为是相似的(例如,10%以内)预定临界值(cutoff)内,则系统可以搜寻查找表格以识别最接近的相应值。如本文所用的,一“相应”值是指在不同时间获取的相同参数的值。该值可以是一大小、一变化率、一平均值或其他。该参数可以是血压、心率、液体量、电解质浓度等。
如果将一个以上参数或一参数的值与查找表格中的数据相比较,则系统可以确定各参数的各值是否在被认为是相似的预定临界值内,并且可以通过优先排序或加权参数,或通过合计所有当前值和查找表格中相应值之间的百分比差,来将一先前患者参数数据集确定为最相似的。无论系统是如何确定一当前患者参数数据集较之存储于历史表格中的先前患者数据集是否是相似的或最相似的,均可以做出患者对于系统参数的反应是否是积极的反应884的判断,例如如上文关于图4-图6所描述的,是“更好”(或“效果更好的”)或“最好”(或“效果最好的”),该系统参数与已存储的患者参数数据表格相关联。如果先前的患者反应被判断为是一良好的或“有效果”的反应,则可以根据存储于查找表格中的参数设定当前系统参数892。如果先前的患者反应被认为是不相似的882或没有效果的884,则会对一系统默认的表格进行查询888,该系统默认的表格中包含非患者特异性(non-patientspecific)的系统参数,这种系统参数在一般情况下通常被认为是合适的,或被认为对于表现出当前生理参数的一患者是合适的。然后该系统参数可以根据存储于系统默认表格中的参数设定890。
可以理解的是,先前的患者消极反应(例如,“效果更差的”或“效果最差的”)可以存储于一查找表格中,该查找表格可以以与图7中“有效果的”反应相关的描述类似的方式被读取或使用。在一些实施例中,将“有效果的”的反应和“无效果的”反应分别置于分开的表格中,例如分别置于一“效果提高”的数据表格和一“效果下降”的数据表格中。在一些实施例中,“效果提高”查找表格和“效果下降”的查找表格是同一数据表格,其存储患者参数和关联的系统参数,该关联的系统参数会引起“效果更好的”、“效果最好的”、“效果更差的”或“效果最差的”的患者参数。
为了举例并清楚地说明一血液液体清除系统是如何确定患者参数数据“超出了范围”、“效果更好”、“效果更差”等,(如上文关于图4-图6所描述的),图8所示的数据示意图示出了血压(BP)、心率(HR)和患者血液中钾浓度([K+])的监测数据(非实际数据)的表现。在该示意图中,系统参数在T1,T2,T3和T4的时间点发生改变。图中显示了患者参数(BP、HR、[K+])对血液液体清除系统参数的改变做出的反应变化。如图所示,并非所有的患者参数对一系统参数的改变的反应都是相似的(例如,效果更好或效果更差)。在所示的示意图中,其显示了各患者参数均有一期望的目标值。如果监测到的数据值达到或接近目标值,则可以确定系统参数的改变对于该参数产生了一效果改善或“效果更好”的状况。如果监测到的数据值偏离了目标值,则可以确定系统参数的改变对于该参数产生了一效果恶化或“效果更差”的状况。可以理解的是,对于各患者参数来说,其对系统参数的改变做出反应的时间可以是各不相同的。在某些情况下,患者参数的变化可以在系统参数变化的几秒或几分钟内就可以观测到。在另外一些情况下,患者参数对于系统参数变化的改变可能需要几个小时或更长时间才能被充分地注意或观测到。
在图8示出的监测到的数据的图形描绘中,水平虚线绘出了一下限阈值和一上限阈值。如果一患者参数的监测数据超过了上限阈值或低于下限阈值,则可以确定该参数的值“超出了范围”。
可以理解的是,对于慢性肾病患者,其病情通常会随着时间而恶化。因此,目标值和上限阈值、下限阈值可能随着时间而变化。这些目标值和阈值可以根据例如患者的健康状况或患者参数的状态,通过例如来自一医疗服务提供者的输入而不时地改变。可替代地,该系统可以根据人群数据或一表明一般恶化状况的一特定患者数据,来随着时间自动调整目标值或阈值。如果目标值或阈值被调整到或接近预定的临界值,则可以发出一警报。
进一步地,一个或多个参数的目标值或阈值可以按阶段地进行调整。例如,如果在一给定的治疗阶段之前,患者的液体太多,那么下一个阶段或当前阶段的组织液体水平的目标值或阈值就可以向上调整一些。在一个治疗阶段内清除过多的液体或以过快的速度清除液体带来的消极后果可能会超过患者体内具有较高液体水平带来的消极后果。可以采用额外的或更频繁的液体清除阶段使患者回归到更想要的液体水平。
如图8示出的实例所示的,患者参数随着时间而变化。在实施例中,考虑到可能出现的波动,在一段时间内的一个或多个患者参数的值被平均了。该平均值可以与目标值或阈值相比较,以确定患者状况是否正在改善。通过将一段时间内的值进行平均,明显偏离目标值或超出边界的异常值的影响可能会被削弱。当然,例如如果那些异常值的出现表示患者面临着紧急的健康问题,那么可以为一单一异常值的出现设定阈值。在实施例中,明显偏离于其他附近监测值的一个单一异常值的出现可能会导致一检测后续类似偏差的子程序或监测使用的启动在实施例中,连续不断的明显偏差,在一个给定的样本数中明显偏差占一定的百分比等,都可能导致启动或发出一警告或警报。
在实施例中,患者参数在离散的时间窗口内被测量或被监测,而不是连续地被测量或被监测。这种时间采样对于可植入的系统或具有可植入部件的系统来说是有价值的,因为相对于持续监测,这样可以降低对电源和处理的要求。
关于图3-图8的描述主要针对血液液体清除系统和发生在一血液液体清除阶段的步骤,将系统参数数据和患者参数数据关联起来以改善血液液体清除阶段或定制血液液体清除治疗以进行患者特异性治疗。可以理解的是,可以采用任何合适的使用或过程来达到这样的结果,并且在本文中采用这些使用或过程是可以预想到的。进一步地可以理解的是,可以采用相似的使用或过程在开始一血液液体清除阶段前来改善或定制系统参数,这样可以在一个治疗阶段的开始就设定患者特异性参数。
举例并参阅图9,其为显示了一使用的一流程图,采用该使用来确定在一血液液体清除阶段的开始选定哪种系统参数。所描绘的使用在许多方面与图7所描绘的使用相似。在图9中,该使用包括接收,输入或获取患者或医师的输入900以及患者生理参数910。如上文关于图1的所述,医师或患者的输入可以包括自患者上一次血液液体清除阶段的时间,对于给定的血液液体清除阶段患者需要接受多久的治疗等等。在某些实施例中,系统生成的输入是根据上一阶段期间采集的数据而提供的。患者生理参数可以与上文所描述的那些参数相似。可以查询一历史查找表格920,并且根据患者或医师的输入,患者的生理参数或其他输入等,来确定该患者是否在一相似的情况下在先接受过一血液液体清除阶段930。如果确定该患者在相似的情况下接受过在先血液液体清除阶段930,那么做出何种确定通常是如上文关于图7所述的,做出患者对用于这种在先阶段的系统参数的反应是否是积极的或具有“有效果”的判断940。如果确定患者具有一有效果的反应,那么初始系统参数就可以根据存储于历史表格中的参数来设定950。如果确定患者在相似的情况下没有接受过一血液液体清除阶段930或不具有一有效果的反应940,那么可以查询一默认表格960(例如,与上文关于图7所描述的相似)并根据默认表格中的参数来设定初始系统参数970。
可以理解的是,如上描述的关于图1-图7和图9的过程及其组成,均是用于对本案进行解释而不作为对本案的限制。除了本文所描述的过程步骤,也可以采用该步骤或实施该步骤部件的的衍生。进一步地,图中所示以及文中所描述的过程步骤可以酌情地与可替换的实施例的过程进行互换、替代,或加入到可选的实施例的过程中,或从可选的实施例的过程中省略。
上文所述的过程可以采用任何合适的将液体或液体和污物从血液中清除的装置或系统。该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10-图12为示出了一些装置和系统实例的框图。如图10所示,血液可以从患者10体内抽出,且液体可以通过一血液液体清除装置100被清除,并返回至患者10体内。被清除的液体可以被转移。在一些实施例中,在血液液体清除装置100或系统或其部件是植入的情况下,被清除的液体可以被转移至患者的膀胱。如图10所示进行操作的血液液体清除装置100的实例是超滤和血液过滤装置。此类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。采用某些此类装置,如果装置100以过高的速度或过大的量从血液中清除液体,那么可以将置换液加入到患者血液中。该置换液可以在液体清除前加入到原始血液中,或者可以在血液经过初始的液体清除后且返回至患者的心血管系统前,加入到血液中。优选地,置换液在初始液体清除后被加入。置换液的pH值和电解质浓度是可以被设定或调整的,例如,如下文更详细的描述。
如图11所描绘的实施例所示的,血液液体清除装置100可以采用透析液以帮助从患者血液中清除污物,并维持合适的pH值和电解质平衡。透析液的pH值和电解质浓度是可以被设定或调整的,例如,如下文更详细的描述。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,使用过的透析液和被清除的液体或它们中的一部分可以再生(虚线所表示的再生系统150)成新的透析液,以在血液液体清除阶段中再次利用。用于透析液再生的一种系统是REDY系统,比如在作者为Roberts,M,名称为“再生透析(REDY)吸附剂系统”(theregenerativedialysis(REDY)sorbentsystem),刊登于《肾脏病学》(Nephrology)4:275-278,1998的文中所描述的,该系统可以用于或简单调整后用于本文所描述的实施例中。如图11所示,可以向再生透析液中加入一浓缩液,以将再生透析液的pH值和电解质调节到一个像新的透析液一样适合再使用的量。
无论透析液是否再生,以图11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此类装置及其部件的实例在本领域是公知的。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。
如图12所示,当图11所示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,可以在液体清除的上游或下游将置换液引入到患者的血液中,例如,如上文关于图10所描述的。
无论采用的装置或血液液体清除治疗是怎样的,诸如液体清除速度、血液流动速度或者电解质或pH缓冲液的成分或浓度之类的系统参数均是可控的。图13显示了一些控制透析液或置换液(以及由此的血液)的电解质或pH值的示意性框图,在该图中示出了一用于调节液体的pH值和电解质浓度的一闭环系统的一个实例的代表性部件。
参阅图13,输入数据600(例如,如上文关于图2所描述的输入600)或“获知的”参数可以被呈现在电子控制装置495上,或在其内部被处理,该电子控制装置495构造为控制流量控制元件415,425,435,例如阀。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的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,以调节体相流体(以及由此的血液)中电解质的浓度或pH值。
可以使用任何数量的合适的浓缩液。例如,当确定病人血液内的电解质较低而加入较多量的浓缩液时,以及当确定病人血液内的电解质较高而加入较少量的浓缩液时,一种浓缩物可能是足够的。例如当希望独立地控制pH值和电解质浓度或独立控制不同电解质的浓度时,可能要用到一种以上的浓缩物。
如图13所示的和上文所述的控制元件415,425,435可以是任意合适的控制元件,例如电子控制的阀,电子控制的泵装置等。
任何合适的系统可以被构造为如图13所示的,用于根据输入数据600或“获知的”参数对pH值或电解质的调节进行控制。举例来说,图14-图15阐释了两个示例性系统的所选定的部件。
参阅图14,所示的装置100包括在血液返回到患者体内前向血液中加入置换液的一液体路径。该装置100包括一入口110,用于接收来自患者的血液,以及一出口140,用于将血液返回至患者体内。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14所示的装置100还包括一入口197,用于接收体相置换液(bulkreplacementfluid),一置换液流量控制元件195与入口通信连接,该置换液流量控制元件构造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,用于接收一调节体相置换液的pH值或电解质浓度的浓缩液,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患者体内前控制浓缩液加入到置换液或血液中的速度。优选地,在置换液加入到血液中之前将浓缩液加入到置换液中(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),以在加入到血液之前混合浓缩液和体相置换液。
在图14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。通过控制浓缩液引入到置换液或血液中的速度,就能够控制返回的血液的浓度或pH值(或缓冲量(bufferingcapacity))。
现参阅图15,图15中与图14中编号相同的部件代表相同或类似的部件,其示出了一血液液体清除装置100的所选定部件的一示意框图。在图15所示的实施例中,该装置具有用于接收来自一患者的血液的入口110,一血液流量控制元件120与入口110通信连接,并且构造为控制血液流经中间装置130以从血液中清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相连通,用以将血液返回到患者体内。在所示的实施例中,中间装置130包括一半渗透过滤膜(filter)135,例如一血液透析膜或血液透析滤过膜。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15所示的实施例中,使用过的透析液经过透析液再生中间装置402或部件再生,例如REDY再生中间装置和部件等,以再生出体相透析液。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,例如一阀,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)。通常,再生中间装置或部件402从透析液中清除大量的pH缓冲液或电解质。因此,一含有浓缩的电解质和pH缓冲液的浓缩液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。在某些实施例中,一传感器装置299设在再生中间装置402的下游,用来监测再生透析液成分水平。该传感器装置299可以是一pH值或电解质传感器,从传感器装置299获得数据可以用于确定向再生液体中加入多少浓缩液(该数据可以提供给电子控制装置150)。该传感器装置299可以是一监测血液废物(比如尿素)的传感器装置,以确定该再生中间装置402是否正常工作。废物水平增多或可检出可能表示再生中间装置402或部件可能需要更换或再生。
在所示的实施例中,浓缩液410存放在一储液器410中,储液器410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可以根据如上文所述的输入数据600或“获知的”参数通过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。
图15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。
在所示的实施例中,该装置100还包括一负压控制元件190,其与中间装置部件130的透析液流动腔体相连接。该负压控制元件190可以包括一真空泵或类似物,其可以用于产生或改变一穿过所述膜的压力差,以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,存储器等,其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,从而控制液体从血液中清除的速度。可以理解的是,装置100不需要具有如图15所示的所有这些控制元件120,170,190,用以有效地控制液体从血液里清除的速度。
图14和图15所示的各种控制元件120,150,170,195,415,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。可替代地或另外地,可以采用一系列电子控制的阀。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。
图14和图15示出了设置在一个单元内的部件,可以理解的是,一个或多个部件也可以置于独立的单元内。例如,电子控制装置或其一部分可以置于一独立的装置内,比如一计算机,一平板电脑,一医师编程器等等。所述计算机,平板电脑等可以接收来自传感器装置的输入信息,确定采取恰当的行动,并指示一血液液体清除装置中适当的部件来执行该恰当的行动。
可以理解的是,呈现本文所述的血液液体清除装置和系统及其部件的目的在于解释说明,而并非限制。不同于本文所描述的部件、装置和系统,或者本文描述的部件、装置和系统的衍生,均可以被采用。另外,以上所示和所述装置的部件是可以酌情地在可替换的实施例中进行互换、替换,或可以加入到可替换的实施例的部件中。此外,可以理解的是,在各个附图中,比如图9-图11,尽管所示的各种形状的血液液体清除装置是以在患者体外的方式示出的,如果这些装置或其部件是植入患者体内的,本文所提供的教示也是适用的。
以上所述的装置和系统或其部件,可以用来实施如图1-图7及图9所示的使用或部分使用。当然,任何合适的装置或系统都可以用来实施上文所述的使用或部分使用。
本文所述的使用,包括图1-图7及图9所示的使用,可以由血液液体清除装置或系统,或其他与血液液体清除装置或系统通信连接的装置实施的。这些使用可以是编入该装置的存储器内的算法或指令,其可以由处理器或装置的其他电子控制装置来实施的。优选地,该处理器与装置中合适的控制元件通信连接,并且构造为通过编入的程序指令来控制这些元件,这些编入的程序指令由合适的装置执行。可以理解的是,如上文所述,一编入有使一传感器装置、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,诸如RAM或ROM,一CD或DVD,闪存等。
本文公开了使用、装置、系统、计算机可读介质等的各个情况,下面呈现本文所描述的某些选定情况的概述。
第一种情况是一种由一血液液体清除系统实施的一使用,其包括:(a)以初始系统参数开始一血液液体清除阶段;(b)获得关于一个或多个患者生理参数的一第一数据集;(c)将该第一数据集存储至一迄今为止效果最好的数据集存储器中;(d)将一效果提高查找表格中的所述初始系统参数与所述第一数据集相关联;(e)调整血液液体清除阶段的至少一个参数,以得到调整过的系统参数;(f)在血液液体清除阶段的至少一个参数被调整后,获得关于一个或多个患者生理参数的一第二数据集;以及如果所述第二数据集中的至少一值相较于所述第一数据集中的至少一相应值更接近目标值,则:用所述第二数据集替换迄今为止效果最好的数据集存储器中的所述第一数据集;将关于第二数据集的数据存储在所述效果提高查找表格中;并将关于调整过的系统参数的数据与所述第二数据集相关联。
第二种情况是第一种情况的一使用,其还包括:(a)将所述第一数据集存储至一迄今为止效果最差的数据集存储器中;(b)将一效果下降查找表格中的所述初始系统参数与血液液体清除阶段的至少一个参数调整前的所述第一数据集相关联;以及(c)如果所述第二数据集中的至少一值相较于所述第一数据集中的至少一相应值不是更接近目标值,则:用所述第二数据集替换迄今为止效果最差的数据集存储器中的所述第一数据集;将关于第二数据集的数据存储在所述效果下降查找表格中;并将关于调整过的系统参数的数据与所述第二数据集相关联。
第三种情况是第一或第二种情况的一使用,其还包括:(a)进一步调整血液液体清除阶段的至少一个参数,以得到进一步调整过的系统参数;(b)在血液液体清除阶段的至少一个参数被调整后,获得关于一个或多个患者生理参数的一第三数据集;以及(c)如果所述第三数据集中的至少一值相较于存储在迄今为止效果最好的数据集存储器中的至少一相应值更接近目标值,则:用所述第三数据集替换迄今为止效果最好的数据集存储器中的数据集;并将关于第三数据集的数据存储于所述效果提高查找表格中,且将关于进一步调整过的系统参数的数据与所述第三数据集相关联。
第四种情况是第二种情况的一使用,其还包括:(a)进一步调整血液液体清除阶段的至少一个参数,以得到进一步调整过的系统参数;(b)在血液液体清除阶段的至少一个参数被进一步调整后,获得关于一个或多个患者生理参数的一第四数据集;以及(c)如果所述第四数据集中的至少一值相较于存储在迄今为止效果最差的数据集存储器中的至少一相应值不是更接近目标值,则:用所述第四数据集替换迄今为止效果最差的数据集存储器中的数据集;并将关于第四数据集的数据存储于所述效果下降查找表格中,且将关于进一步调整过的系统参数的数据与所述第四数据集相关联。
第五种情况是第一至第四种情况中任意一种的一使用,其还包括:(a)获得关于一个或多个患者生理参数的一第五数据集;(b)将所述第五数据集与所述效果提高查找表格进行比较;以及(c)如果存储于所述效果提高查找表格中的一数据集的至少一个参数在所述第五数据集的一预定范围内,则调整系统参数,该系统参数与存储于所述效果提高查找表格中的数据集相关联。
第六种情况是第一至第五种情况中任意一种的一使用,其还包括:(a)停止血液液体清除阶段;(b)获得关于一个或多个患者生理参数的一第六数据集;(c)将所述第六数据集与所述效果提高查找表格进行比较;以及(d)如果存储于所述效果提高查找表格中的一数据集的至少一个参数在所述第六数据集的至少一个参数的一预定范围内,则以系统参数开始一第二血液液体清除阶段,该系统参数与存储于所述效果提高查找表格中的数据集相关联。
第七种情况是第一至第六种情况中任意一种的一使用,其中一个或多个患者参数的至少其中之一选自血压,心率,pH值和一电解质的。
第八种情况是第七种情况的一使用,其中所述电解质为钾。
第九种情况是第一至第七种情况中任意一种的一使用,其中所述系统参数包括液体清除速度中的一个或多个以及一种或多种电解质的浓度。
第十种情况是一血液液体清除系统,其包括:(a)一血液液体清除中间装置,其构造为清除来自于一患者的血液,其中血液进入所述中间装置,液体从血液中被清除,并且血液流出所述中间装置;(b)一个或多个控制元件,其构造为控制:(i)所述中间装置从血液中清除液体的速度,或(ii)从所述中间装置流出的血液的电解质浓度或pH值;(c)一个或多个传感器装置,其构造为监测患者的一个或多个生理参数;以及(d)电子控制装置,其包括存储器和一处理器,其中所述电子控制装置与一个或多个传感器装置可操作地通信连接,该电子控制装置与一个或多个控制元件可操作地耦合,其中所述电子控制装置构造为执行如第一至第九种情况中的任意一种的一使用。
第十一种情况是第十种情况的一系统,其中所述血液液体清除中间装置和所述电子控制装置容纳于一血液液体清除装置中。
第十二种情况是第十种情况或第十一种情况的一系统,其还包括一计算机可读介质,其中所述计算机可读介质包括指令,该指令使得所述电子控制装置来执行如权利要求1至9中任意一项所述的使用。
第十三种情况是一种血液液体清除系统,其包括:(a)一血液液体清除中间装置,其构造为清除来自于一患者的血液,其中血液进入所述中间装置,液体从血液中被清除,并且血液流出所述中间装置;(b)一个或多个控制元件,其构造为控制:(i)所述中间装置从血液中清除液体的速度,或(ii)从所述中间装置流出的血液的电解质浓度或pH值;(c)一个或多个传感器装置,其构造为监测患者的一个或多个生理参数;以及(d)电子控制装置,其包括存储器和一处理器,其中所述电子控制装置与一个或多个传感器装置可操作地通信连接,该电子控制装置与一个或多个控制元件可操作地耦合,其中所述电子控制装置构造为:(i)以初始系统参数开始一血液液体清除阶段;(ii)获得关于一个或多个患者生理参数的一第一数据集;(iii)将所述第一数据集存储至一迄今为止效果最好的数据集存储器中;(iv)将一效果提高查找表格中的所述初始系统参数与所述第一数据集相关联;(v)调整血液液体清除阶段的至少一个参数,以得到调整过的系统参数;(vi)在血液液体清除阶段的至少一个参数调整后,获得关于一个或多个患者生理参数的一第二数据集;以及(vii)如果所述第二数据集中的至少一值相较于所述第一数据集中的至少一相应值更接近目标值,则:用所述第二数据集替换迄今为止效果最好的数据集存储器中的所述第一数据集;将关于第二数据集的数据存储在所述效果提高查找表格中;并将关于调整过的系统参数的数据与所述第二数据集相关联。
第十四种情况是一种计算机可读介质,其包括指令,当该指令通过一血液液体清除装置执行时,其使得该装置:(a)以初始系统参数开始一血液液体清除阶段;(b)获得关于一个或多个的患者生理参数的一第一数据集,存储所述第一数据集至一迄今为止效果最好的数据集存储器中;(c)将一效果提高查找表格中的所述初始系统参数与所述第一数据集相关联;(d)调整血液液体清除阶段的至少一个参数,以得到调整过的系统参数;(e)在血液液体清除阶段的至少一个参数被调整后,获得关于一个或多个患者生理参数的一第二数据集;以及(f)如果所述第二数据集中的至少一值相较于所述第一数据集中的至少一相应值更接近目标值,则:用所述第二数据集替换迄今为止效果最好的数据集存储器中的所述第一数据集;将关于第二数据集的数据存储在所述效果提高查找表格中;并将关于调整过的系统参数的数据与所述第二数据集相关联。
第十五种情况是一种由一血液液体清除系统实施的一使用,其包括:(a)获得关于下列项中的一个或多个的数据:(i)一个或多个患者生理参数;和(ii)距离上一个血液液体清除阶段的时间;(b)获得关于一血液液体清除阶段的一个或多个目标结果的数据;(c)确定一个或多个目标结果的至少其中之一是否在一预定范围内,该预定范围是存储于一查找表格中的、至少一相应在先目标结果的一预定范围,其中,所述查找表格包括关于用于患者的一个或多个在先血液液体清除阶段的系统参数的数据;(d)判断至少一个目标结果是否是以用于在先血液液体清除阶段的系统参数来实现的;(e)若该至少一个目标结果被判断为已经实现,则判断至少一个患者参数或距离上一个血液液体清除阶段的时间是否在一预定的范围内,该预定范围是存储于所述查找表格中的至少一个相应参数的一预定范围;及(f)若至少一个患者参数或距离上一个血液液体清除阶段的时间被判断为在一预定范围内,则采用在先血液液体清除阶段使用的系统参数来开始一血液液体清除阶段。
第十六种情况是第十五种情况的一使用,其中所述一个或多个患者参数的至少其中之一选自血压,心率,pH值和一电解质的浓度。
第十七种情况是第十六种情况的一使用,其中所述电解质是钾。
第十八种情况是第十五至第十七种情况中的任意一种的一使用,其中所述系统参数包括液体清除速度中的一个或多个以及一种或多种电解质的浓度。
第十九种情况是一种血液液体清除系统,其包括:(a)一血液液体清除中间装置,其构造为清除来自于一患者的血液,其中血液进入所述中间装置,液体从血液中被清除,并且血液流出所述中间装置;(b)一个或多个控制元件,其构造为控制:(i)所述中间装置从血液中清除液体的速度,或(ii)从所述中间装置流出的血液的电解质浓度或pH值;(c)一个或多个传感器装置,其构造为监测患者的一个或多个生理参数;(d)一输入装置,其构造为输入关于患者参数或系统参数的数据;以及(e)电子控制装置,其包括存储器和一处理器,其中所述电子控制装置与一个或多个传感器装置可操作地通信连接,该电子控制装置与一个或多个控制元件以及输入装置可操作地耦合,其中所述电子控制装置构造为执行如第十五至第十八种情况中的任意一种的一使用。
第二十种情况是第十九种情况的一系统,其中所述血液液体清除中间装置和所述电子控制装置容纳于一血液液体清除装置中。
第二十一种情况是第十九种或第二十种情况的一系统,其还包括一计算机可读介质,其中所述计算机可读介质包括指令,该指令使得所述电子控制装置执行第十五至第十八种情况中的任意一种所述的使用。
第二十二种情况是一血液液体清除系统,其包括:(a)一血液液体清除中间装置,其构造为清除来自于一患者的血液,其中血液进入所述中间装置,液体从血液中被清除,并且血液流出所述中间装置;(b)一个或多个控制元件,其构造为控制:(i)所述中间装置从血液中清除液体的速度,或(ii)从所述中间装置流出的血液的电解质浓度或pH值;(c)一个或多个传感器装置,其构造为监测患者的一个或多个生理参数;(d)一输入装置,其构造为输入关于患者参数或系统参数的数据;以及(e)电子控制装置,其包括存储器和一处理器,其中所述电子控制装置与一个或多个传感器装置可操作地通信连接,该电子控制装置与一个或多个控制元件以及输入装置可操作地耦合,其中所述电子控制装置构造为:(i)获得关于下列项中的一个或多个的数据:一个或多个患者生理参数;距离上一个血液液体清除阶段的时间;(ii)获得关于一血液液体清除阶段的一个或多个目标结果的数据;(iii)判断一个或多个目标结果的至少其中之一是否在一预定范围内,该预定范围是存储于一查找表格中的、至少一相应在先目标结果的一预定范围,其中,所述查找表格包括关于用于患者的一个或多个在先血液液体清除阶段的系统参数的数据;(iv)判断至少一个目标结果是否是以用于在先血液液体清除阶段的系统参数来实现的;(v)若确定该至少一个目标结果已经实现,则判断至少一个患者参数或距离上一个血液液体清除阶段的时间是否在一预定的范围内,该预定范围是存储于所述查找表格中的至少一个相应参数的一预定范围;及(vi)若确定至少一个患者参数或距离上一个血液液体清除阶段的时间在一预定范围内,则采用在先血液液体清除阶段使用的系统参数来开始一血液液体清除阶段。
第二十三种情况是一种计算机可读介质,其包括指令,当指令通过一血液液体清除装置执行时,其使得该装置:(a)获得关于下列项中的一个或多个的数据:一个或多个患者生理参数;距离上一个血液液体清除阶段的时间;(b)获得关于一血液液体清除阶段的一个或多个目标结果的数据;(c)判断一个或多个目标结果的至少其中之一是否在一预定范围内,该预定范围是存储于一查找表格中的至少一相应在先目标结果的一预定范围,其中,所述查找表格包括关于用于患者一个或多个在先血液液体清除阶段的系统参数的数据;(d)判断至少一个目标结果是否是以用于在先血液液体清除阶段的系统数据来实现的;(e)若确定至少一个目标结果已经实现,则判断至少一个患者参数或距离上一个血液液体清除阶段的时间是否在一预定的范围内,该预定范围是存储于所述查找表格中的至少一个相应参数的一预定范围;及(f)若确定至少一个患者参数或距离上一个血液液体清除阶段的时间在一预定范围内,则采用在先血液液体清除阶段使用的系统参数来开始一血液液体清除阶段。
第二十四种情况是由一血液液体清除系统实施的一使用,其包括:(a)采集关于一患者的第一数据,该数据包括一个或多个生理参数以及距离上一个血液液体清除阶段的时间;(b)采集关于患者血液液体清除阶段采用的系统参数的第二数据;(c)根据采集到的第一和第二数据,判断系统参数的采用是否改善了至少一个患者生理参数;(d)判断当前患者数据的一值是否在一预定范围内,该预定范围是采集到的第一数据的一相应值的一预定范围;及(e)如果确定这些参数存在,且如果确定当前患者数据在预定范围内,则采用引起改善的系统参数。
第二十五种情况是一血液液体清除系统,其包括:(a)一血液液体清除中间装置,其构造为清除来自于一患者的血液,其中血液进入所述中间装置,液体从血液中被清除,并且血液流出所述中间装置;(b)一个或多个控制元件,其构造为控制:(i)所述中间装置从血液中清除液体的速度,或(ii)从所述中间装置流出的血液的电解质浓度或pH值;(c)一个或多个传感器装置,其构造为监测患者的一个或多个生理参数;(d)一输入装置,其构造为输入关于患者参数或系统参数的数据;以及(e)电子控制装置,其包括存储器和一处理器,其中所述电子控制装置与一个或多个传感器装置可操作地通信连接,该电子控制装置与一个或多个控制元件以及输入装置可操作地耦合,其中所述电子控制装置构造为执行第二十四种情况的一使用。
第二十六种情况是第二十五种情况的一系统,其中所述血液液体清除中间装置和所述电子控制装置容纳于一血液液体清除装置中。
第二十七种情况是第二十四种或第二十五种情况的一系统,其还包括一计算机可读介质,其中所述计算机可读介质包括指令,该指令使得所述电子控制装置执行如第二十四种情况所述的使用。
第二十八种情况是一血液液体清除系统,其包括:(a)一血液液体清除中间装置,其构造为清除来自于一患者的血液,其中血液进入所述中间装置,液体从血液中被清除,并且血液流出所述中间装置;(b)一个或多个控制元件,其构造为控制:(i)所述中间装置从血液中清除液体的速度,或(ii)从所述中间装置流出的血液的电解质浓度或pH值;(c)一个或多个传感器装置,其构造为监测患者的一个或多个生理参数;(d)一输入装置,其构造为输入关于患者参数或系统参数的数据;以及(e)电子控制装置,其包括存储器和一处理器,其中所述电子控制装置与一个或多个传感器装置可操作地通信连接,该电子控制装置与一个或多个控制元件以及输入装置可操作地耦合,其中所述电子控制装置构造为:(i)采集关于一患者的第一数据,该数据包括一个或多个生理参数以及距离上一个血液液体清除阶段的时间;(ii)采集关于患者血液液体清除阶段采用的系统参数的第二数据;(iii)根据采集到的第一和第二数据,判断系统参数的采用是否改善了至少一个患者生理参数;(iv)判断当前患者数据的一值是否在一预定范围内,该预定范围是采集到的第一数据的一相应值的一预定范围;及(v)如果确定这些参数存在,且如果确定当前患者数据在预定范围内,则采用引起改善的系统参数。
第二十九种情况是一种计算机可读介质,其包括指令,当指令通过一血液液体清除装置执行时,该指令使得该装置:(a)采集关于一患者的第一数据,该数据包括一个或多个生理参数以及距离上一个血液液体清除阶段的时间;(b)采集关于患者血液液体清除阶段采用的系统参数的第二数据;(c)根据采集到的第一和第二数据,判断系统参数的采用是否改善了至少一个患者生理参数;(d)判断当前患者数据的一值是否在一预定范围内,该预定范围是采集到的第一数据的一相应值的一预定范围;及(e)如果确定这些参数存在,且如果确定当前患者数据在预定范围内,则采用引起改善的系统参数。
这样,血液液体清除的自适应系统的系统,装置和使用就均在本文被描述了。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。
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”数据集并不一定是暗示有三个数据集,而是区别于“第一”数据集的。再进一步举例,一“第三”数据集并不必须是排在一“第一”数据集之后的。
Claims (6)
1.一种血液液体清除系统,其包括:
一血液液体清除中间装置,其构造为清除来自于一患者的血液,其中血液进入所述中间装置,液体从血液中被清除,血液流出所述中间装置;
一个或多个控制元件,其构造为控制:(i)所述中间装置从血液中清除液体的速度,或(ii)从所述中间装置流出的血液的电解质浓度或pH值;
一个或多个传感器装置,其构造为监测患者的一个或多个生理参数;以及
电子控制装置,其包括存储器和一处理器,其中所述电子控制装置与一个或多个传感器装置可操作地通信连接,该电子控制装置与一个或多个控制元件可操作地耦合,其中所述电子控制装置构造为执行一使用,该使用包括:
以初始系统参数开始一血液液体清除阶段;
获得关于一个或多个患者生理参数的一第一数据集;
将该第一数据集存储至一迄今为止效果最好的数据集存储器中;
将一效果提高查找表格中的所述初始系统参数与所述第一数据集相关联;
调整血液液体清除阶段的至少一个参数,以得到调整过的系统参数;
在血液液体清除阶段的至少一个参数被调整后,获得关于一个或多个患者生理参数的一第二数据集;以及
如果所述第二数据集中的至少一值相较于所述第一数据集中的至少一相应值更接近目标值,则:用所述第二数据集替换迄今为止效果最好的数据集存储器中的所述第一数据集;将第二数据集的数据存储在所述效果提高查找表格中;将调整过的系统参数的数据与所述第二数据集相关联。
2.如权利要求1所述的系统,其中所述血液液体清除中间装置和所述电子控制装置容纳于一血液液体清除装置中。
3.如权利要求1所述的系统,其还包括一计算机可读介质,其中所述计算机可读介质用于使得所述电子控制装置执行所述使用。
4.一种血液液体清除系统,其包括:
一血液液体清除中间装置,其构造为清除来自于一患者的血液,其中血液进入所述中间装置,液体从血液中被清除,血液流出所述中间装置;
一个或多个控制元件,其构造为控制:(i)所述中间装置从血液中清除液体的速度,或(ii)从所述中间装置流出的血液的电解质浓度或pH值;
一个或多个传感器装置,其构造为监测患者的一个或多个生理参数;
一输入装置,其构造为输入关于患者参数或系统参数的数据;以及
电子控制装置,其包括存储器和一处理器,其中所述电子控制装置与一个或多个传感器装置可操作地通信连接,该电子控制装置与一个或多个控制元件以及输入装置可操作地耦合,其中所述电子控制装置构造为执行一使用,该使用包括:
采集关于一患者的第一数据,该数据包括一个或多个生理参数和距离上一个血液液体清除阶段的时间;
采集关于患者血液液体清除阶段采用的系统参数的第二数据;
根据采集到的第一和第二数据,判断系统参数的采用是否改善了至少一个患者生理参数;
判断当前患者数据的一值是否在一预定范围内,该预定范围是采集到的第一数据的一相应值的一预定范围;以及
如果确定这些参数存在,且如果确定当前患者数据在预定范围内,则采用引起改善的系统参数。
5.如权利要求4所述的系统,其中所述血液液体清除中间装置和所述电子控制装置容纳于一血液液体清除装置中。
6.如权利要求4所述的系统,其还包括一计算机可读介质,其中所述计算机可读介质用于使得所述电子控制装置执行所述的使用。
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