CN1099895C - 具有可变压力驱动的腹膜透析系统 - Google Patents
具有可变压力驱动的腹膜透析系统 Download PDFInfo
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Abstract
一种用于对病人进行腹膜透析的系统,包括一个由液压操作的以便使液体向病人的腹腔流入或由病人腹腔流出的液体泵;一个可向泵导入或由泵导出流体以便操作液体泵的液体管路;一个将负压连接至管路和液体泵的真空源,以便将液体吸入液体泵;一个将正压连接至管路和液体泵的正压压力源,以便将液体从液体泵排出;和一个包括流量比例阀的流体配给系统,以便控制由相应的压力和真空源流经管路的流体的流速和压力,它可使液体泵运行,以便将液体泵入腹腔或由腹腔泵出。
Description
本申请要求在先的1995年9月8日递交的申请号为60/003452的美国临时申请的优先权。
本发明涉及一种改进的自动腹膜透析(APD)系统,供包含作为在腹膜透析时给以非经肠的液体的临床治疗用。
目前已知,患有部分或完全性肾衰竭的病人需要进行腹膜透析治疗。通常可采用的腹膜透析方法有两种类型。人工腹膜透析是使袋内的透析液靠重力通过管线进入延伸至病人腹腔的内导管中。授予Kamen等的美国专利5350357公开的装置,可以进行自动的腹膜透析。Kamen等的自动腹膜透析系统是一种供家庭使用的有吸引力的系统,它占地较小,使病人可以在晚上自己用存储在若干个包中的新鲜的透析液为自己进行若干次透析。这种自动系统包括有一个可将透析液的温度由室温加热到人体温度的加热器,还包括一个与循环控制装置相耦合的一次性液体传输组件,前者可将气动压力供给至传输组件的预定部分,以便把透析液从透析液袋通过传输组件泵给加热器袋,再由加热器袋泵给病人,再经人体至排出处。新鲜的腹膜透析溶液被注入病人的腹腔,在此通过透析交换,将诸如钠和氯离子的溶液,尿,肌酸液和水等的废弃物传递到腹腔的透析溶液中,再将其由腹腔中排出。Kamen等的系统是通过注入,中止保持,以及排出阶段一个接一个的实施的方式运行的。这种系统的优点之一就是,不论实际的落差是多少,均可仿真出一个固定的落差或不同的高度差。在给定的腹膜透析的实施条件下,该系统可以在相当低的压力模式和相当高的压力模式之间迅速的开关切换,其中相对较低的压力用在向病人注入阶段和由病人人体的排出阶段,而高压模式用在不与病人直接接触的管线之中传递透析液的阶段。然而,该系统需要使用大量的高压和低压容器,以便能将气动压力传递至气动接口,因此还需要大量与其相连接的阀。由于容器和阀的数量较多,故使得该系统相对较大,其中该系统为触发透析液泵只限于选择几种气动压力,而且,它不能获得可选的压力时间特征曲线,例如它不能根据给定的透析液治疗过程,尽可能快的或是尽可能慢的升高或降低该气动压力。
Kamen等的系统是在不对气动压力的供给水平进行调节的状态下运行的,这对于某些病人的治疗是不利的。
因此,需要提供有一种具有循环控制装置的自动腹膜透析系统,该循环控制装置能将大范围的气动压力或压力分布通过液体传输组件传递至一次性透析液的迷宫式连接盒,该盒可将透析液溶液传送给病人或由病人人体上传出。
本发明给出了一种可通过将透析液传输至病人人体并将使用过的透析液排出,实施自动腹膜透析的的系统,该系统包括一个自动腹膜透析装置或称循环控制装置,它具有一个可向气动供气或配给系统提供控制信号的电控制器。该气动供给系统包括一个或多个用于控制提供给迷宫式连接盒接口的空气压力的流量比例阀。
由于可用流量比例阀调节由压缩器或真空泵接收到的空气压力,故这种系统可减少在先技术中的气动系统所使用的那种类型的蓄气容器的需求,容器的减少,又可使气动配给系统简化,进而减少在该系统中所使用的阀数。使用一个或多个流量比例阀,还可以使到达透析液迷宫式连接盒的膜片泵处的驱动压力具有预定的特征参数,这可使其在治疗处理中具有最大的可适用性,而且可以使病人更安全,更舒适。较少数目的蓄气容器和阀,还使得本系统能小型化,且运行更安静。
迷宫式连接盒接口用于接收一次性透析液传输系统的一次性的透析液的流动及泵出迷宫式连接盒。该一次性透析液传输系统与位于迷宫式连接盒接口处的循环控制装置相连接,并用迷宫式连接盒接口给出的空气压力驱动,以便能够按照在病人人体和透析液供给包之间的动态压力分布泵出透析液,且能够在较大的透析液压力范围内将其排出,从而能够在透析液注入和透析液中止保持阶段,以及在透析液排出阶段,确保病人的安全,并使其感到舒适。
本发明的一个主要的目的,是要提供一种用于在可变的压力下将透析液供给病人,且确保病人的安全和舒适的自动腹膜透析系统。
根据本发明,提供了一种用于对病人进行腹膜透析的系统,包括:
a)一个由液压操作的以便使液体向病人的腹腔流入或由病人腹腔流出的液体泵;
b)一个可向泵导入或由泵导出流体以便操作液体泵的液体管路;
c)一个将负压连接至管路和液体泵的真空源,以便将液体吸入液体泵;
d)一个将正压连接至管路和液体泵的正压压力源,以便将液体从液体泵排出;
e)一个包括流量比例阀的流体配给系统,以便控制由相应的压力和真空源流经管路的流体的流速和压力,它可使液体泵运行,以便将液体泵入腹腔或由腹腔泵出。
本发明还提供了一种液体泵系统,其特征在于包括:
a)一个具有膜片的第一液体泵;
b)一个具有膜片的第二液体泵;
c)一个用于驱动每一个液体泵的流体配给系统,它具有
i)选择器阀装置;
ii)流量比例装置;
iii)位于选择器阀装置和流量比例装置与第一和第二液体泵之间的管路装置;
d)一个正压压力源,用于将液体从每个液体泵排出;
e)一个真空源,用于将液体吸入每个液体泵。
本发明的其它的目的通过本领域的技术人员仔细阅读了下面的参考附图给出的说明和权利要求将会更加清楚。
图1是本发明的一个实施例的自动腹膜透析(APD)系统的透视图,该系统具有一个自动腹膜透析装置或循环控制装置和一个液体输送装置;
图2是图1所示的自动腹膜透析系统的透视图;
图3是图1所示的自动腹膜透析系统的后视透视图;
图4是图1所示的自动腹膜透析系统的部分分解的透视图,它示出了其中的压缩器、真空泵、一组气动阀和一次性透析液的迷宫式连接盒保持器;
图5是图1所示的自动腹膜透析系统的方框图;
图6是图1所示的自动腹膜透析系统处于与进行透析的病人相连接的状态时的正视图;
图7是图1所示的自动腹膜透析系统的各组件的机械布置的示意图;
图8是图1所示的自动腹膜透析系统的迷宫式连接盒固定器和与其相连接的一次性透析液的迷宫式连接盒的部分分解的局部透视图;
图9是图1所示的自动腹膜透析系统的气动接口的后视图;
图10是图9所示的气动接口后视图;
图11是图9所示的气动接口后视图,它详细地示出了其中的气动式容积测量腔室;
图12是图1所示的气动接口和带有循环控制装置的门组件的另一部分的透析液迷宫式连接盒的分解的透视图;
图13是图12所示的部分门组件的分解透视图,它示出了器中的门气囊和堵塞气囊的具体结构;
图14是处于与减压后的门气囊啮合位置的门组件的剖视图;
图15是图14所示的增压后的门气囊的门组件的剖视图;
图16是部分门组件的剖面图,它详细的示出了当增压时阻塞气囊使透析液在一次性透析液传送组件流过的作用;
图17是图17所示的门组件的部分剖面图,它示出了阻塞器减压的气囊和阻塞器阻断透析液在一次性透析液传送组件中流过;
图18是一次性透析液迷宫式连接盒的剖开了的分解透视图;
图19是图18所示的一次性透析液迷宫式连接盒的主体一侧的正视图;
图20是图19所示的一次性透析液迷宫式连接盒的主体的另一侧的正视图;
图21是图18所示的的一次性透析液迷宫式连接盒的部分放大了的剖视图,它详细地示出了透析液阀;
图22是图1所示的APD系统的气动系统的示意性方框图;
图23是用于加热透析液袋的加热器回路的方框图;
图24至28是用于APD系统的第二实施例的多个阀、压缩器和真空泵的电子控制和功率配给系统的示意性方框图;
图29是图1所示的APD系统的控制器的方框图;
图30是用于操作在一次性迷宫式连接盒中的液体阀的气动阀的第一实施例的控制系统的部分示意性方框图,以便控制透析液向一次性迷宫式连接盒的左侧膜片泵的流动;
图31是用于操作在一次性迷宫式连接盒中的液体阀的气动阀的第一实施例的控制系统的部分示意性方框图,以便控制透析液向一次性迷宫式连接盒的右侧膜片泵处的流动;
图32是用于四个大型的数字型气动阀的控制系统的示意性方框图。
图33是用于提供功率控制信号的固态延迟控制电子组件的示意性方框图。
图34是压力比例电子组件的示意性方框图,该组件可响应误差信号提供比例电位阀控制信号,以控制模拟流量比例控制阀;
图35是在图29所示的触发器板内的电力连接的示意性方框图。
图36为表示在触发器板和与计算机的接口相连接的数据接收板之间的总线接线示意方框图。
图37是图29所示的传感器板的一部分的示意方框图,它具有可将14.55伏DC变换为5.000伏DC的精确参考电压;
图38是具有可将14.55伏DC变换为5.100伏DC的精确参考电压的部分传感器板的示意性方框图;
图39是具有可将14.55伏变换为10.000伏的精确参考电压的部分传感器板的示意性方框图;
图40为表示传感器板的一部分的示意性方框图,它示出了一个电缆头和三个精确参考电压;
图41是部分传感器板的示意性的说明图,它示出了一个用于将14.55伏的DC电力提供给传感器板的电缆头;
图42至47是具有热电耦且安装在传感器板上的温度传感电路的示意性方框图;
图48是安装在如图29所示的装在电力板DC电力输入组件的示意性方框图。
图49是电力供给组件的示意性方框图,它用于向加热器和压缩器电力电子组件提供电力,并安装在功率板上;
图50示出了功率供给输出头组件;
图51是AC输入模块的示意方框图;
图52是DC电力供给的示意方框图;
图53是具有多个压力传感器和与有关接口的模拟传感器输入回路的示意方框图,它用于传递由压力传感器检测到的压力和加热器包温度以及类似参数相关的信号;
图54是图1所示的APD系统的气动系统的第二实施例的示意方框图;
图55为表示如图54所示的气动回路的一个典型部分的示意方框图。
图56是气动分配组件的一个简单变型的第三实施例的示意方框图。
图57是图56所示的气动分配组件的、在体外透析液注入循环阶段过程时的一组工作压力与时间的曲线图;
图58是图56所示的气动分配组件的、在体外透析液排出循环阶段过程时的一组工作压力与时间的曲线图;
图59为表示使用如图1所示的APD系统的气动系统的第四实施例的示意方框图。
下面参考附图,特别是图1至图6进行说明。自动腹膜透析(APD)系统在图中一般用标号10表示。APD系统10包括有自动腹膜透析装置,或称循环控制装置12,它具有一个向气动供给或称配给系统16提供供给控制和驱动信号的电控制器14。气动配给系统16可在可变的压力下向气动的迷宫式连接盒接口18提供空气。反馈回路19由气动配给系统16向控制器14提供反馈信号。
一次性液体或称透析液输送系统20包括有一个一次性液体或透析液输送装置21,它与迷宫式连接盒的气动接口18相耦合。多个透析液袋22连接到一次性透析液的输送装置21上,以通过一次性透析液输送装置21提供以葡萄糖为主体的透析液。该输送装置21包括一次性透析液迷宫式连接盒23,用于与透析液排出管24相连接,并通过病人用管26与和连接对病人28的导管27相接。
循环控制装置12具有壳体32,并将电子控制器14、气动供给系统和气动的迷宫式连接盒接口18收装在其内。
正如图29和51所示,控制器14接收来自适当的电源的交流电力。
电子控制器14包括一个计算机34,后者可以是一个设置在壳体32中的置于电路板或类似物上的镶嵌式微处理器,也可以是一个分离设置型的个人计算机。计算机34亦可以是一个IBM便携式个人计算机,它具有一个与一条或多条系统总线相连接的微处理器,一个用于存储运行所需的程序指令和数据的随机存取存储器,和一个以永久形式存储程序和数据信息的、与系统总线相连接的硬盘;还有一个用以对计算机系统进行程序和数据的输入和输出的软驱。一个视频显示监测器通过视频控制模块与计算机总线相连接。该视频显示监测器可显示出与自动腹膜透析系统10的运行有关的控制和提示指示。还可包括一个用于输入命令和向系统10发出询问用的键盘。该键盘可用来响应视频显示终端的瞬时提示。该键盘还可向计算机34的其它部分发出命令,以使其能按如此方式对电控制器14的其它部分进行控制,使透析液注入操作开始,使包括被加热袋的注入操作在内的透析液中止保持操作开始,或使透析液排出操作开始。作为上述的键盘的一种替换形式,也可以将一个可用于输入命令和向系统10发出询问用的控制面板直接装在循环控制装置的壳体上或是其附近,并与计算机相连接,如果在系统中采用了镶嵌式微处理器,则采用这种变换形式更好些。
计算机34可由控制器的其它部分通过RS-232线36输入数字信息,并通过RS-232线38输出数字型信号。RS-232输入线36可接收来自传感器板40的数字信号,而计算机可向触发器板42发出命令信息。
正如图51所示,电控制器14具有一个AC输入模块50,该模块具有一对用于接收来自适当的电源的交流电流的交流电线输入端子52和54。交流电流通过端子52和54供给至开关56,当开关闭合时,便将交流电流通过一对保险丝58和60供给至AC总线62。一对功率输出插接连接件64和66连接到AC总线62上。正如图29和52所示,直流电力供给器68在插接连接件66处接收交流电流的输入,并通过插接连接件72将直流电流供给至DC总线70。而且正如图29和48所示,该直流通过插接连接件72供给至DC功率输入模块74。钽电容器76和电解电容器78用于除去直流电流中的波动,并通过导线80向控制器14的其它部分提供正的14.55伏的电位。正如图29和50所示,电流电力还通过DC功率模块82输出,并通过导线84向控制器的其它部分提供正的14.55伏的电位。
当使用者指令计算机34开始透析操作时,计算机通过串联连接线36向数模变换器板,在本实施例中是向Keithley-Metrabyte DDA06输出板90,发出装置指令信号。该数模变换器板90将指令信号变换为模拟的压缩器、加热器和气动阀控制信号。正如图36所示,该模拟控制信号可通过控制信号总线92传递。连接控制信号总线92,以便能将模拟控制信号传递到左侧阀控制信号总线94、右侧阀控制信号总线96、流量比例阀控制信号总线98、通路选择阀控制信号总线100,以及组合的加热器和压缩器控制信号总线102。
当自动腹膜透析系统10被接通时,其指令由计算机产生。耦合固态延迟控制电子模块110,以便接收来自压缩器和加热器控制总线102的信号。正如图33所示,它可以接收这些信号,使它们通过ULN 2003A驱动器112,再通过多个负载电阻器114输入至延迟控制总线116,该总线与加热器功率电子模块118和压缩器功率电子模块120相耦合。
正如图29和49所示,加热器功率模块118和压缩器功率模块120可通过DC功率供给总线80,由DC电力触发。AC电力可通过AC总线64提供,以驱动加热器功率模块118和压缩器功率模块120。三个加热器功率场效应晶体管130、132和134分另耦合在相应的门控制导线136、138和140上,各导线通过总线116相连接。加热器功率晶体管130至134控制着AC电力,从而可通过加热器电力供给导线150、152和154,驱动与其相连接的一对透析液袋加热器160和162中的一个或是两个。加热器160和162与热传导铝制加热器包底盘166有着良好导热关系,在后者的上面可放置着一个透析液袋22,即加热器透析液袋22,从而可以将其加热至大约37℃,即加热到人体的体温。
交流电流电力还通过交流电流导线64施加至一对气动驱动功率场效应晶体管170和172,它们通过压缩器导线174和176将AC电力送入至一对压缩器178。这一对压缩器178是气动控制系统16的一部分,并可将高于和低于大气压力的空气供给至气动控制系统的其它部分,以进行最终调制后再供给至气动接口18。
正如图29、36和34所示,由数模卡90给出的阀指令信号,通过阀信号总线92供给至压力比例电子模块180。更具体地说,由数模卡90给出的比例阀指令信号,可通过比例阀控制总线98输出到一组阀驱动放大器190,所述放大器与比例流量阀总线210相连接。这一组阀驱动放大器190包括有一个正的左侧放大器192、一个负的左侧放大器194、一个正的右侧放大器196,和一个负的右侧放大器198。正的左侧放大器192驱动着功率晶体管200。类似的,放大器194、196和198分别驱动着相应的功率晶体管202、204和206,并且正如图29所示,通过包括比例阀控制总线210的一部分的、相应的比例流量阀控制信号导线201、203、205和207,可将比例流量阀驱动信号输出到一组模拟阀212。每一个放大器均可作为增益约为1.25的线性放大器使用,它提供一个阀控制信号,以便按预定的量打开与其相连接的比例流量阀。正如图35所示,可用功率供给总线84提供的正的14.55伏的信号驱动压力比例电子组件180。
正如图29至32所示,数模转换模块90可响应计算机34给出的信号,通过数字型阀控制电子组件控制多个三通阀。由数模转换模块90延伸的左侧阀控制总线,可通过ULN 2003驱动器将阀控制信号供给至一组与第一组三通阀相耦合的直通阀控制导线220。类似的,右侧阀控制总线96可通过ULN 2003驱动器104,向与右侧通/断阀相连接的右侧阀控制总线222提供信号,以控制气流通过第二组位于气动接口18处的阀触发器开口。
正如图32所示,由总线100给出的气动通路选择控制阀信号供给ULN2003型驱动器224和通路选择阀控制总线226,以控制选择(routing)由压缩器到气动系统16的其它部分的高压和低压气体的流动。
压缩器178包括作为正压力泵使用的第一压缩器240和作为真空泵使用的第二压缩器242,它们分别与AC控制线174和176相连接,以接收电力,并根据计算机34的指令开始运行。压缩器178将正7.5磅/每平方英寸的高压气体供给至正压线244,并传送到一个八阀歧管246。负压或真空系统242将负7.5磅/每平方英寸的真空压施加在真空管线248。
该压力被传递到第一压力歧管管线250,用于在该八阀歧管中分配压力,并通过检测阀252供给至第二正压管线254,以提供给其它阀和两个蓄气容器或类似物。管线248中的真空被传递到第一歧管真空管线258和第二歧管真空管线260。
由歧管管线250提供的正压,可通过检测阀262到达三通阀264,后者正如图22和32所示,可由总线226中的导线之一接收信号。
系统把正压力通过高压管线270传输给门气囊272,用于把液体输送装置21的迷宫式连接盒23保持在与气动接口18良好的连接接触。压力变换器P5与管线270相连接,以测量其压力。在门气囊阀264的其它部分上,还耦合着一个排出管线。
类似的,正压歧管250通过检测阀280与亦由总线226驱动,并通过阻塞压力管线284与阻塞气囊286相连接的阻塞气囊阀门282相连接。在减压时,该阻塞气囊可产生阻塞,使液体传送组件的柔软管线弯曲,以阻塞住液体传送组件的透析液流动部分,防止在电源故障时其中的透析液流出。
十阀歧管包括有左侧正压比例流量阀290,该阀与由阀控制信号进行控制的信号导线201相耦合,它还包括有右侧正压比例流量阀292,它与信号导线205相连接以由其阀控制信号进行控制。类似的,左侧负压比例流量阀294与负压歧管258相耦合,并由导线203的信号进行控制。右侧负压比例流量阀298由导线207的信号进行控制。
左侧正压阀和真空比例流量阀290和292通过管线300与泵压传送管线302相连接,以便测量气体流速和气动接口18的传送压力,以控制传送给迷宫式连接盒23上的左侧膜片泵中之一的气动压力。类似的,由于在迷宫式连接盒中使用了两个膜片泵,即左侧膜片泵和右侧膜片泵,所以可用阀292和298由管线310向312提供所选择的调制压力,管线312用于向气动接口18提供压力,以向一次性透析液迷宫式连接盒23上的右侧膜片泵传送压力。
正如图22所示,在气动配给系统中使用一个或多个流量比例阀290、292、294、298可以调节由压缩器240输出的压力或由真空泵242输出的真空,从而可以将预定大小的压力或真空传递给泵触发器PA1和PA2。可以从能确保病人的安全和舒适的角度考虑,适当的进行压力和真空的调节,以避免被泵入至病人的腹部腔体中的透析液产生突发性的起伏,如果将压缩器输出的气动压力不进行调制就送入至泵触发器,就往往会发生上述的情况。可以对流量比例阀进行控制,以获得到任意数量的预定气动压力与时间的关系曲线中的某一条特征曲线,其方式可以是相应于压力与时间的关系曲线中的由泵P1和P2泵出的液体透析液的压力调高或调低气动泵的触发压力或真空。最好是使用接近于线性或类似曲线。流量比例阀可相对于系统10的操作给出最大的可变通性,而且因为它们可以调节由压缩器给出的原始压力或真空,所以可以减小对多个蓄气容器的需求,即使有此需要也是为了保持某些不同的压力水平。
由于在迷宫式连接盒主体中调节由气动接口18供给至液体控制阀的空气压力并不是必须的,所以亦可通过高压管线254和真空管线252将原始的高压和真空分别提供给左侧三通阀组件320和右侧三通阀组件322。左侧三通阀组件320控制着对气动接口18中的阀触发器的压力和真空的供给。它包括一个加热器气动阀324、一个排出气动阀326、一个最终的透析液气动包阀328、一个透析液供给气动阀330和一个病人用气动阀332。类似的,右侧歧管322由一个加热器气动阀340、一个排出气动阀342、一个最终的透析液气动包阀344、一个供给气动阀346和一个病人用透析液气动阀348构成。气动阀组件320和322中的气动阀,通过一组柔性供给管线349气动地与气动外围设备接口18相连接。这一组柔性供给管线349包括,一个与阀324相连接的加热器供给管线350、一个与阀326相连接的排出供给管线352、一个与阀328相连接的最终供给管线354、一个与阀330相连接的包或称透析液供给管线356和一个与阀332相连接的病人用供给管线358。
加热器供给管线350与阀触发器VA1相连接。管线352与触发器VA2相连接。在迷宫式连接盒23的右侧部分,加热器管线360与阀340相连接,排出管线372与阀342相连接,最终透析液袋管线374与阀344相连接,供给或称透析液袋管线376与阀346相连接,而且病人管线378与阀348相连接。
阀触发器VA3与加热器管线370相连接,阀触发器VA4与排出管线372相连接,阀触发器VA5与最终供给管线473相连接,阀触发器VA6与管线376相连接,阀触发器VA7与管线378相连接,阀触发器VA8与病人用供给管线358相连接,阀触发器VA9与病人用供给管线356相连接,而阀触发器VA10与病人用供给管线354相连接。
如上所述,用于气动压力调节和获得压力与时间的关系曲线的流量比例阀290、292、294、298的使用(如图22所示)使其能够减小对多个气动蓄气容器的需求,即使需要这些容器也是保持某些不同压力水平。而且,蓄气容器数量的减少又使得可以减少气动阀的数量,如在压力配给系统中使用了这种蓄气容器时往往是需要这些气动阀的。从图22可以看出,本发明所导致的气动阀数量上的减少。当泵触发器PA1和PA2由流量比例阀接收调制的气动压力或真空,以便调节由泵P1和P2泵出的透析液的压力和流量时,最好是使阀触发器VA1-10能够接收到预定大小的压力或真空,而不需要由气动流量比例阀进行调节,从而保证液体阀V1-10能够完全打开或是完全闭合,或相当快的由一种位置移动到另一种位置。
左侧的标准容积蓄气容器390通过管线392与阀394相连接,而后者与管线302相连接并由总线226进行控制。压力变换器PT3与管线392相连接,而压力变换器PT1与管线302相连接。与压力变换器PT1和PT3以及容积蓄气容器390相联通的阀394,被用来测量与迷宫式连接盒的左侧薄膜泵相关的绝对压力和泵特性以及类似参数。
类似的,右侧的标准容积蓄气容器400通过气动管线402,以便接收来自与总线226相连接的阀404的高压空气。压力变换器PT0和PT2分别与气动管线312和402相连接,由此阀404随时都可以使右侧压力触发器与标准容积蓄气容器相连接,并可以测量在连接前后的压力,从而提供压力变换器信号。压力变换器PT6与管线284相连接,以便向微处理器34提供作为着阻塞气囊的状态的信号。压力变换器P4与正压管线相连接,压力变换器PT5与门气囊管线270相连接。
在图1和12至15可以更好的看到,当包括在壳体32上铰接安装的门452的门组件450运行时,它适宜于支托和连接在门组件450中的液体输送组件的部分组件,并使其与气动接口18良好的气动连接。门组件450包括一个构成部分迷宫式连接盒保持器的前板454,该前板454通常呈矩形并具有基本上在其内形成的呈矩形的迷宫式连接盒的接受孔456。迷宫式连接盒接受孔456是在后板460内伸延出的迷宫式连接盒接受内槽458的一部分。后板460还具有一个阻塞组件的一部分上伸延穿过的槽缝462。由后板458的前面体461上伸延出的是一个用于与门452栓锁啮合的栓锁销钉466,这样,当迷宫式连接盒23位于门组件450中时,可以可靠的保持住门452。与后板470相对设置的是一个弹性泡沫材料制的弹簧元件470,它具有一个基本上在其内界定的呈矩形的窗472,并且具有一个安装在栓锁销钉466的相对侧的、用于保持迷宫式连接盒23与气动接口18的良好的气动啮合的预制成型垫片480。该预制成型垫片480包括有用于防止泄露出的透析液进入气动接口18的整体弹性防溅保护膜482,和一组在其上形成的小的空气逸出孔484,用于与柔性管线气动连通,而这些管线与阀触发器VA1-10和作为气动系统的其它部分的泵P1和P2,以及气动接口18的其它出入孔口相耦合。一对泡沫嵌入体设置在垫片480的后侧,并与气动接口18的泵触发器PA1和PA2相连接,以平滑由气动接口18到迷宫式连接盒23的压力传递。
迷宫式连接盒保持模块还包括有基本上呈矩形的压力板500,且在其后设置有一个门气囊272。在门气囊272的相对侧设置有一个保持门气囊272用的框体,而阻塞气囊286设置在框体502的另一侧。一个可移动的阻塞气囊504设置在与框体142相对的阻塞气囊286的一侧,以使阻塞气囊286设置在它们之间。当阻塞气囊286被增压,伸长了的阻塞气囊506将远离框体502的另一部分被抬起。一个伸长了的侧钩元件508配置在可移动阻塞主体504的相对侧,以便为整个主体504在阻塞气囊286的影响下移动提供一个枢轴,一对阻塞弹簧510耦合在与可移动阻塞主体504相连接的一对轴套512上。
正如图11所示,图中所示的另一种气动接口18,与如图10所示的气动接口基本上相同,只是它们的压力测量容积体VSR和VSL是附设在气动接口18的后面,并且每一个均用热传导泡沫嵌入体117充填。该热传导泡沫嵌入体可作为热传导体,它平滑了作为沿管线312和392通过流量比例阀供给的特征压力的压力变化。这有助于减少作用于病人的可能使其感到不舒适的压力峰值。
正如图21所示,迷宫式连接盒主体23包括有一个前侧582和一个后侧584。多个直立增强肋586支持着实现密封连接的中空柱590的膜片614,而中空柱在突起的阀座处形成了一个出入孔口591。当膜片与柱的上侧部分相连接时,柱内的流体不与第二出入孔口594相联通。
在使用中,透析液输送装置21的迷宫式连接盒23以这样的方式配置在迷宫式连接盒保持器中亦使多个柔性管通过阻塞体。正如图19、20和21所示,迷宫式连接盒21包括着迷宫式连接盒主体23,后者在其一侧有五个透析液出入孔。它们是加热器包孔600、排出孔602、最终透析液袋孔604、供给袋或称透析液供给孔606和病人用孔608。在该迷宫式连接盒主体中形成有许多个通道,其中的一些与这些出入孔口相连接。在其中还包括一对泵腔室P1和P2。泵腔室和通道由一对柔性塑料膜片612和614密切。
加热器包孔600与加热器包通道F1相连接。排出孔602与排出通道F2相连接。最终包孔604与最终包通道F3相连接。供给孔606与透析液供给通道504相连接,而病人用孔608与病人用透析液通道F5相连接。泵腔室P1包括一个上侧泵腔室出入孔620和一个下侧泵腔室出入孔622。泵腔室P2包括一个上侧泵腔室出入孔624和一个下侧泵腔室出入孔626。泵腔室P1的上侧泵腔室出入孔620通过泵腔室P1的上侧分配通道F6,可与加热器包通道F1或排出通道F2相耦合。泵腔室P2的上侧出入孔624通过泵腔室P2的上侧分配通道F7,可与加热器包通道F1或排出通道F2相耦合。
以一种类似的构成方式,泵腔室P1的下侧出入孔622可通过泵腔室P1的下侧泵通道F8与最终包通道F3、供给通道F4或病人用通道F5相耦合。泵腔室P2的下侧出入孔626可通过下侧泵腔室P2的分配通道F9与最终包通道F3、供给通道F4或病人用通道F5相耦合。
十阀站在主透析液通道F1至F5和泵腔室分配通道F6至F9之间提供,以使其有效耦合。具体地说就是,阀站V1使加热器包通道F1与泵通道F6相耦合。阀V2使排出通道F2与泵腔室P1的上侧分配通道F6相耦合。阀站V3使加热器包通道F1与泵腔室P2的上侧分配通道F7相耦合。阀站V4使排出通道F2与泵腔室P2的上侧分配通道F7相耦合。
阀V5使最终包通道F3与泵腔室P2的下侧通道F9相耦合。阀V6使供给通道F4与泵腔室P2的下侧分配通道F9相耦合。阀V7使病人用通道F5与泵腔室P2的下侧分配通道F9相耦合。
阀V8使病人用通道F5与泵腔室P1的下侧通道F8相耦合。阀V9使供给包通道F4与泵腔室P1的下侧分配通道F8相耦合。阀V10使最终包供给通道F3与泵腔室P1的下侧分配通道F8相耦合。
当阀V1-V10在低压状态下打开,并将低压由气动接口施加到膜片闭合的阀区域时,将使阀打开,并形成上述的选择流通连接。当高压通过相应的阀触发器VA1至VA10,施加至迷宫式连接盒上的各自的阀站V1至V10时,各个阀将保持闭合。因此,由歧管320和322上的各个阀进行的、在阀触发器VA1至VA10处的压力的控制,控制着在出入孔600至608和泵腔室P1和P2之间的透析液的分配方式。
与此同时,压力通过流量比例阀施加至泵腔室的泵触发器PA1和PA2,从而移开位于与这些腔室接近的膜片部分,从而使泵开始运行。
当透析液传递到病人,由病人传递出,以及传递到各个袋时,迷宫式连接盒有时可以由用加热器159加热了的加热袋22中引入透析液。正如图29和42至47所示,热电耦组件700提供指示加热袋的温度的温度信号。该信号temp0至temp5可由热电耦状态调节电子组件702,通过模拟温度信号总线704传递到模数变换卡706,特别是一种Keithley-MetrabyteDAS1402型模拟输入卡。模拟输入卡706再将数字温度信号通过总线36传递到计算机34,由计算机34调节由加热器功率电子组件118接收的控制信号。
更具体地,由图42至47所示的每一个电路均是类似的,且均包括有与放大器712相耦合的热电耦710,以将放大后的输出信号通过跨接器714传递到第二放大器716,再传递到第三级放大器718,由后者提供输出信号。类似的,正如图43所示,热电耦720可产生由第一放大器722、第二放大器724和第三放大器726放大后的信号。热电耦730的输出信号由放大器732、734和736放大后,供给至总线704。正如图45所示,第五热电耦740的输出信号由放大器742、744和746放大后,供给至总线704。正如图46所示,第五热电耦750的输出信号由放大器752、754和756放大后,供给至总线704。正如图47所示,第六热电耦760的输出信号由放大器762、764和766放大后,供给至总线704。
以一种类似的构成方式,压力变换器的输出信号可通过反馈总线19施加至模数模块706,这正如图29和53所示。该压力信号被数字化,并供给至计算机34,由计算机34监视各个气囊的压力,还监视流体流速,并且控制模拟阀或流量比例阀212,以选择传送压力并提供给泵触发器PA1和PA2,从而选定在迷宫式连接盒23的泵腔室P1和P2中的压力。
在典型的三阶段APD循环的注入阶段中,循环控制装置12可将透析液由加热器包22传递至病人。加热器袋22附装在迷宫式连接盒的最前端的出入孔口处。病人用管线附装在迷宫式连接盒的最上端的孔处。注入阶段包括将透析液经由初始液体通道F1和分支液体通道F6,送入迷宫式连接盒的泵腔室P1。然后,泵腔室P1将加热后的透析液通过分支液体通道F8挤出到初始液体通道F5。
为了进行泵的挤出操作,循环控制装置14最好能使与泵腔室P1相串联的泵腔室P2亦开始工作。控制器14可将加热后的透析液经由初始液体通道F1和分支液体通道F7,送入泵腔室P2。然后,泵腔室P2将该加热后的透析液通过分支液体通道F9,挤出到初始液体通道F5。控制器14可使泵腔室P1工作在泵入冲程,而使泵腔室P2工作在泵出冲程,或是相反。
在这一步骤中,加热的透析液总是被导入泵腔室P1和P2的顶部。加热的透析液总是通过泵腔室P1和P2的底部部分以隔绝空气的方式排出到病人人体。
而且,在将液体直接传递到病人人体的过程中,控制器14可以对泵触发器PA1和PA2提供相当低的正压或负压。
一旦将预定的注入体积量传递给了病人,循环控制装置12便进入第二或称中止保持阶段。在中止保持阶段,循环控制装置12可通过由源透析液袋22中的某一个传递出新鲜的透析液的方式,补充加热器袋。
补充加热器袋的阶段包括,将新鲜的透析液经由初始液体通道F4和分支液体通道F8送入迷宫式连接盒的泵腔室P1。然后,由泵腔室P1将透析液通过分支液体通道F6挤出到初始液体通道F1。
为了进行泵的挤出操作,控制器14最好能使与泵腔室P1相串联的泵腔室P2亦开始工作。循环控制装置12可将新鲜的透析液经由初始液体通道F4和分支液体通道F9送入泵腔室P2。然后,泵腔室P2将该透析液通过分支液体通道F7挤出到初始液体通道F1。
循环控制装置12可使泵腔室P1在泵入冲程工作,而使泵腔室P2在泵出冲程工作,或是相反。
在这一步骤中,新鲜的透析液总是被导入泵腔室P1和P2的底部。而且,新鲜的透析液总是通过泵腔室P1和P2的顶部排出至加热器袋。这可以使滞留的空气由泵腔室P1和P2中排出。
由于液体传递并不是直接作用于病人人体,所以控制器14可以对泵触发器PA1和PA2提供相对较高的正压和负压,而不会影响到病人。
在中止保持阶段结束后,循环控制装置12进入第三或称排出阶段。在排出阶段,循环控制装置12可将使用过的透析液由病人人体28传递至排出处。该排出阶段包括将使用过的透析液经由初始液体通道F5和分支液体通道F8送入至迷宫式连接盒的泵腔室P1。然后,由泵腔室P1将透析液通过分支液体通道F6挤出到初始液体通道F2。
为了进行泵的挤出操作,控制器最好能使与泵腔室P1相串联的泵腔室P2亦开始工作。循环控制装置12可将使用后的透析液经由初始液体通道F5和分支液体通道F9送入至迷宫式连接盒的泵腔室P2。然后,泵腔室P2将该透析液通过分支液体通道F7挤出到初始液体通道F2。
循环控制装置12可利用传感器PT1和PT2检测压力,以确定病人的腹腔是否已经排空。在排出阶段之后,可进行如前所述的下一个注入阶段和中止保持阶段。
在最后一个注入/中止保持/排出循环之后,某些APD过程还要用循环控制装置进行最终的一次注入操作。该最终的注入体积药量要在病人人体中保持一天。在晚上的下一个CCPD期间开始时再将其排出。最终的注入体积药量可以与循环控制装置进行的下一个CCPD注入/中止保持/排出循环中的注入体积药量具有不同的葡萄糖浓度。在整个一天的中止保持循环过程中,该选定的葡萄糖浓度将受到水的超滤作用。
在这一阶段中,循环控制装置由最终的注入袋向病人人体注入新鲜的透析液。该最终注入袋附装在迷宫式连接盒的第三出入孔处。
在最后的中止保持阶段,加热器袋将排空由最终注入袋传递至该加热器包的溶剂。这样,可将该最后注入溶剂传递至病人人体,以完成该最终注入阶段。
最终的中止保持阶段包括将液体经由初始液体通道F1和分支液体通道F6,由加热器袋送入泵腔室P1。然后,由泵腔室P1将该液体通过分支液体通道F6挤出到初始液体通道F2。
为了进行加热器袋的挤出排出操作,循环控制装置12能使与泵腔室P1相串联的泵腔室P2亦开始工作。循环控制装置12可将液体经由初始液体通道F1和分支液体通道F7,由加热器袋送入至泵腔室P2。然后,泵腔室P2将该液体通过分支液体通道F7,挤出到初始液体通道F2。
一旦最终注入溶剂已经加热,它就在上述的注入循环中,传递至病人人体。
根据本发明的一个方面,APD过程中的每一个重要的步骤均是由空气压力控制的。空气压力使液体流经传输组件,并根据固定的或可变化的落差高度条件模仿重力流动条件。空气压力控制着各个阀的动作,从而使液体在多个目的地和源之间流动。空气压力可密封住触发器中的迷宫式连接盒,而且当条件合适时,可对相应的管线实施安全阻塞。空气压力是进行透析液体积测量的基础,而后者是通过对液体中逸出的空气进行检测和消除,并对阻塞的液体流动条件进行检测和识别而获得的。
在如图54和55所示的本配给系统的第一替代实施例中,压缩器800把高压空气传递到管线802,然后再通过检测阀804传递到门气囊阀806和体积测量阀808。门气囊812与其均压化的阀806相连接,而门气囊压力传感器820测量门气囊的压力。高压空气也提供至选择器阀822,再传递至适用于接收其压力高于大气压力的空气的流量比例阀824,而该空气是由泵管线826施加至泵触发器PA1。不规则的或称原始高压空气被施加至高压歧管830,以及一对阀触发器歧管832和834,以便按与前述的实施例相类似的方式,将高压空气传递至阀触发器VA1至VA10。真空泵850向选择器阀822和选择器阀852提供低于大气压力的压力。
第二流量比例阀853连接至此,用于将选定的压力真空通过管线854向压力触发器PA2传递。原始真空被提供至管线860,它分配给阀组件832和834,以便当一组阀832和834中的一个或多个被选定后,向阀触发器传递压力。还连接有一个阻塞气囊。以接收高压空气,且该系统按与前述的压力调节系统相类似的方式动作,不同的是它仅依据两个流量比例阀824和852进行动作,而不是依据四个流量比例阀,所以可以降低生产成本。
这种系统的一个典型的例子如图55所示,它仅采用了一个流量比例阀使高压通过检测阀900与选择器阀902和阻塞气囊904相连接,并且具有一个与其相连接的流量和压力测量系统910。门气囊920接收来自压缩器800的高压空气,压力触发腔室922可接收流量比例阀824给出的高压或低压空气。还连接有一个用于接收不规则的高压或低压空气的阀触发器924。该系统相对简单一些,而且仅需要相对较少的出入孔,便可以获得前述的实施例所给出的压力特征曲线。
正如图56所示,本配给系统的第三实施例包括,分别与带排气孔的减压阀1004和1006相连接的压缩器或称压力源1000和真空源1002。减压阀1008使压力与阻塞气囊1010相耦合,而减压阀1012使压力与门气囊1014相耦合。负压蓄气容器1016通过阀1006与真空泵1002相连接,而门气囊和该负压蓄气容器还通过选择器阀1020与阀触发器1022相连接。选择器阀1024可将真空或正压耦合至流量比例阀1026,后者将处于被测压力下的流量提供给泵触发器1030。
包括蓄气容器1042的压力测量系统1040与泵腔室1030相耦合,以测量由此排出的液体的量。由于仅采用一个流量比例阀,即可对于一次性泵腔室完成加压和真空冲程两项工作,故该系统相对简单一些。
如图56所示的系统的运行,可用如图57所示的压力曲线图进行说明。其中,最下侧的曲线代表着真空源压力;从下边数第二条曲线代表着右侧泵腔室的腔室压力;最上侧的曲线代表着正压供给器或称压缩器的压力;而从上边数第二条曲线代表着左侧泵腔室的腔室压力。在图58中,类似的曲线代表着仅使用单一泵腔室时的场合,其中上侧和下侧曲线代表着正压和负压源的压力,中间的曲线代表着单一泵腔室的压力。
正如图59所示,该系统的另一个实施例包括一个压力调节器系统1100。该压力调节器系统1100包括与阻塞气囊1104以及一个负压蓄气容器1106相耦合的组合式压缩器和真空泵1102。高压门气囊1108与阻塞气囊平行的耦合,并具有一个与其相连接的压力变换器1110。多个三通选择器阀1120与一组包括有气动接口一部分的阀触发器1122相连接。选择器阀1130与流量比例阀1132相连接,而后者又与泵触发器1134相连接。流量测量系统1136亦与其相连接。负压蓄气容器通过管线1150与第一组选择器阀1120和第二组选择器阀1152相连接。在第二组选择器阀1152运行时,可将空气或真空传递到多个阀触发器1154处。泵触发器1160可通过流量比例阀1162被驱动,而后者可通过选择器阀1164由负压蓄气容器或高正压门气囊接收正压或是负压。该系统也可以用最少数目的组件和蓄气容器,获得压力特征曲线。流量测量系统1170与泵触发器1160相连接,以便把流量测量值返回计算机。
本发明的其它特征还包括在下述的权利要求中。
Claims (7)
1.一种用于对病人进行腹膜透析的系统,其特征在于包括:
a)一个由液压操作的以便使液体向病人的腹腔流入或由病人腹腔流出的液体泵;
b)一个可向泵导入或由泵导出流体以便操作液体泵的液体管路;
c)一个将负压连接至管路和液体泵的真空源,以便将液体吸入液体泵;
d)一个将正压连接至管路和液体泵的正压压力源,以便将液体从液体泵排出;
e)一个包括流量比例阀的流体配给系统,以便控制由相应的压力和真空源流经管路的流体的流速和压力,它可使液体泵运行,以便将液体泵入腹腔或由腹腔泵出。
2.如权利要求1所述的对病人进行腹膜透析的系统,其特征在于液体配给系统包括一个用于将真空源或压力源选择的与液体泵相连接的选择器阀。
3.如权利要求2所述的对病人进行腹膜透析的系统,其特征在于液体泵包括有一个具有膜片和流体腔室的膜片泵,而流体配给系统还进一步包括有第二流量比例控制阀和第二选择器阀,且每一个流体腔室均与一个流量比例阀和一个选择器阀相连接。
4.如权利要求1所述的对病人进行腹膜透析的系统,其特征在于流体配给系统还进一步包括一个第二流量比例控制阀和一个泵腔室。
5.如权利要求1所述的对病人进行腹膜透析的系统,其特征在于它还包括有一个用于阻止液体流入病人腹腔或由病人腹腔流出的液体阻塞器,所述的液体阻塞器与所述的流体配给系统相连接并由其操作运行;以及一个位于所述的液体配给系统中的阀,用于当系统不能阻止液体流动时,使来自阻塞器的气流能实施阻塞器的运行。
6.一种液体泵系统,其特征在于包括:
a)一个具有膜片的第一液体泵;
b)一个具有膜片的第二液体泵;
c)一个用于驱动每一个液体泵的流体配给系统,它具有
i)选择器阀装置;
ii)流量比例装置;
iii)位于选择器阀装置和流量比例装置与第一和第二液体泵之间的管路装置;
d)一个正压压力源,用于将液体从每个液体泵排出;
e)一个真空源,用于将液体吸入每个液体泵。
7.如权利要求6所述的液体泵系统,它还进一步包括多个与第一和第二液体泵相连接的液体阀,和多个用于接收来自正压液体源和真空液体源的正压液体和真空液体的触发器阀,以便把液体阀连接到流体分配系统并受其控制。
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US08/702,878 US5938634A (en) | 1995-09-08 | 1996-08-23 | Peritoneal dialysis system with variable pressure drive |
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CN1099895C true CN1099895C (zh) | 2003-01-29 |
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EP (1) | EP0790841B2 (zh) |
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CN (1) | CN1099895C (zh) |
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- 1996-09-05 AT AT96930718T patent/ATE197407T1/de active
- 1996-09-05 KR KR1019970703046A patent/KR970706856A/ko active IP Right Grant
- 1996-09-05 DE DE69610896T patent/DE69610896T3/de not_active Expired - Lifetime
- 1996-09-05 CN CN96191041A patent/CN1099895C/zh not_active Expired - Fee Related
- 1996-09-05 CA CA002204503A patent/CA2204503C/en not_active Expired - Fee Related
- 1996-09-05 EP EP96930718A patent/EP0790841B2/en not_active Expired - Lifetime
- 1996-09-05 ES ES96930718T patent/ES2153978T5/es not_active Expired - Lifetime
- 1996-09-05 JP JP51138797A patent/JP3375137B2/ja not_active Expired - Fee Related
- 1996-09-05 WO PCT/US1996/014258 patent/WO1997009074A2/en active IP Right Grant
-
2001
- 2001-02-02 GR GR20010400185T patent/GR3035360T3/el unknown
-
2002
- 2002-09-20 JP JP2002276383A patent/JP2003102834A/ja not_active Withdrawn
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
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WO1990013795A2 (en) * | 1989-05-01 | 1990-11-15 | Deka Products Limited Partnership | Enhanced pressure measurement flow control system |
EP0402505A1 (en) * | 1989-06-15 | 1990-12-19 | Alan M. Peabody | Continuous cyclic peritoneal dialysis system |
WO1994020158A1 (en) * | 1993-03-03 | 1994-09-15 | Deka Products Limited Partnership | Peritoneal dialysis system |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1829545B (zh) * | 2003-07-31 | 2010-06-16 | 生物技术公司 | 用于进行腹膜透析的系统 |
CN104436341A (zh) * | 2014-12-09 | 2015-03-25 | 昆山韦睿医疗科技有限公司 | 一种腹膜透析设备及其语音控制方法 |
Also Published As
Publication number | Publication date |
---|---|
DE69610896D1 (de) | 2000-12-14 |
DE69610896T2 (de) | 2001-05-23 |
ES2153978T3 (es) | 2001-03-16 |
GR3035360T3 (en) | 2001-05-31 |
US5938634A (en) | 1999-08-17 |
WO1997009074A2 (en) | 1997-03-13 |
EP0790841A1 (en) | 1997-08-27 |
CA2204503C (en) | 2001-11-27 |
WO1997009074A3 (en) | 1997-07-03 |
CN1165484A (zh) | 1997-11-19 |
DE69610896T3 (de) | 2005-04-07 |
JP3375137B2 (ja) | 2003-02-10 |
EP0790841B1 (en) | 2000-11-08 |
ES2153978T5 (es) | 2005-07-01 |
ATE197407T1 (de) | 2000-11-11 |
JPH10508787A (ja) | 1998-09-02 |
JP2003102834A (ja) | 2003-04-08 |
MX9702910A (es) | 1997-07-31 |
EP0790841B2 (en) | 2004-12-15 |
KR970706856A (ko) | 1997-12-01 |
BR9606629A (pt) | 1998-01-06 |
CA2204503A1 (en) | 1997-03-13 |
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