CN101534878B - 用于腹膜透析机的数据通信系统 - Google Patents

用于腹膜透析机的数据通信系统 Download PDF

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CN101534878B
CN101534878B CN2007800407247A CN200780040724A CN101534878B CN 101534878 B CN101534878 B CN 101534878B CN 2007800407247 A CN2007800407247 A CN 2007800407247A CN 200780040724 A CN200780040724 A CN 200780040724A CN 101534878 B CN101534878 B CN 101534878B
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库尔温德尔·S·普莱海伊
特里·莱
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Abstract

一种便携腹膜透析设备(10)，其具有USB接口，用于使用USB快闪驱动器上传和下载患者的文件和记录，并用于在机器本身的显示器上播放经由USB快闪驱动器传送的PD机的培训视频。

Description

用于腹膜透析机的数据通信系统
技术领域
本发明一般涉及用于治疗晚期肾病的设备。更具体地，本发明涉及执行腹膜透析的便携设备。
背景技术
众所周知透析是用来支持那些肾功能已经衰退到肾脏不再充分地起作用的程度的患者。利用两种主要的透析方法：血液透析和腹膜透析。
血液透析中，患者的血液流经人造肾脏透析机。机器中的薄膜充当人造肾脏，用于净化血液。由于该治疗是在人体外的，因此它需要特殊的机器并需要去执行该治疗的中心，例如，医院。
为了克服与血液透析相关的不足，开发了腹膜透析(以下称之为“PD”)。PD利用患者自身的腹膜(人体腹腔的膜衬)作为半透薄膜。由于腹膜灌注佳，因此它能够充当天然的半透薄膜。
PD周期性地向腹膜腔灌注消毒的水溶液。该水溶液被称为PD溶液或简称为透析液。经过腹膜在该溶液和血流之间发生扩散和渗透交换。这些交换去除肾脏正常排泄的废物。该废物通常由诸如尿素和肌酸酐的溶解物组成。肾脏还具有维持诸如钠和水的其他物质的适当水平的作用，它们也需要通过透析来调节。在透析期间，水和溶解物经过腹膜的扩散被称为超过滤。
在连续流动的PD中，利用导尿管将透析液引入到腹膜腔，导尿管通常通过去医生那里来安放。通过扩散实现透析液和血液之间的溶解物的交换。
在许多现有技术的PD机中，去除体液(fluid)是通过提供从血液到透析液的合适的渗透梯度以允许水从血液中流出来实现的。这使得在身体中获得酸碱、电解质和体液的适当平衡。透析液简单地通过导尿管从体腔中排出。去除体液的速度是由患者和机器之间的高度差控制的。
优选的PD机是自动化的机器。这些机器被称作循环控制装置(cycler)，被设计用来自动地向患者的腹膜腔灌注、驻留PD溶液以及从患者的腹膜腔排出PD溶液。循环控制装置对PD患者特别有吸引力，因为它能够在夜晚当患者睡觉时使用。这能够免除患者日复一日地在他/她醒着时和工作时间需要连续流动的PD。
治疗通常持续若干个小时。其经常开始于初始排出循环以清空腹膜腔中失效的透析液。该程序接着是一连串相继进行的注满、驻留和排出阶段。每个阶段都称为一个循环。
本发明的目的在于提供用于PD循环控制装置的改进的数据通信。
发明内容
一方面中，根据本发明的腹膜透析机包括：控制器，用于指示PD循环控制装置上的操作顺序来执行对患者的腹膜透析；和USB数据通信接口，该接口包括在机器上的接受USB快闪驱动器的USB端口、以及USB接口控制系统，该系统用于管理腹膜透析相关数据的上传和下载，该相关数据诸如跟踪治疗的治疗数据、患者的简档和处方的数字化记录以及可使用内置的媒体播放器在机器的显示器上播放的针对相同机器的培训视频。
另一方面中，本发明包括通过在PD机上提供包括USB端口的USB接口、以及使用插入在该端口中的USB快闪驱动器来与该机器进行通信的方法，该方法或者通过向USB快闪驱动器传送患者数据并将用户的USB快闪驱动器插入到端口中来将患者数据上传到机器，或者通过向USB控制器传送治疗数据并将用户的USB快闪驱动器插入到端口中并接着传送该数据到用户的USB快闪驱动器上以传送到PC来将治疗数据下载给用户。
又一方面中，本发明包括使用用来传送文件的USB接口和用来在PD机本身的显示屏上播放培训视频的内置媒体播放器来在PD机上播放由用户的USB快闪驱动器提供的培训视频。
附图说明
在下面的附图和描述中阐述本发明的一个或多个实施例的细节。根据描述和附图以及权利要求，本发明的其他的特征、目的和优点将变得明显。
图1是在特殊手推车上的PD循环控制装置的透视图，该手推车配备有在加热盘上的加热袋和挂在该手推车上的用于更多交换的额外的PD溶液袋；
图2是该PD循环控制装置中的USB接口系统的方框图。
在几张图中，指代相同部分的标号将具有相同的参考标号。
具体实施方式
下面所描述的USB接口专门设计用于在2005年2月28日提交的、美国专利申请号为11/069,195、名称为“用于腹膜透析疗法的便携装置”中公开的那种类型的PD循环控制装置，该申请通过引用全部合并于此。另外，本申请在此通过引用合并与本申请同日由Kulwinder Plahey提交的、申请号为______(代理案卷号为18196-061001)、名称为“用于腹膜透析机的改进的盒式系统”的伴随申请(companion application)中公开的内容。前述申请被转让给同一受让人并描述了在本申请图1中所示的PD循环控制装置的实施例的某些细节。
循环控制装置(cycler)
图1中示出便携PD循环控制装置10位于手推车12的顶部，该手推车设计用于容纳PD溶液袋和相关联的配管(tubing)。循环控制装置10的前部包括控制面板12，控制面板12配备有要由患者操作的用户接口以及在铰接门(hinged door)14后面的加压盒仓(pressurized cassette compartment)。该盒(未示出)包括通道、弹性阀圆拱顶(flexible valve dome)以及覆盖泵室的膜片(diaphragm covered pumping chamber)。该泵室通过将气压阀和与盒仓接口连接的活塞紧密配合来将PD溶液通过循环控制装置从袋子引导到患者并从患者引导到排出装置(drain)。在以上引用的申请序号为11/069,195的申请中更具体地公开了该盒和盒仓。该盒本身具有沿其底边排列的配管连接器(tubing connector)16。如图1中所示，该连接器伸到门14的下面并与配管相连接。
如所示，PD溶液袋18悬挂在手推车12的侧面的指状物上。加热袋20被示出放置在形成加热盘22的浅的凹陷中。加热盘22的大小和形状可容纳一般5升的PD溶液袋。加热盘22具有多个嵌在表面下面的加热线圈(未示出)。盘22的表面略微向右下方倾斜以有助于排空所放置的加热袋，因此加热袋的排出口也在右侧，临近位于加热盘22表面的温度传感器24，该温度传感器用来为温度调节控制电路跟踪加热袋中溶液的温度，该温度调节控制电路根据需要来接通和关断加热线圈以使PD溶液保持在期望的温度。加热盘22还在内部安装有具有测压元件(load cell)(未示出)的支撑物(support)，用来提供指示PD溶液袋的容纳物的重量的电信号，来告诉循环控制装置的控制系统加热袋的PD溶液有多满。
PD循环控制装置具有基于中央编程的微处理器的控制器，用于依照患者的处方指导透析治疗。在多个患者的情况中，对于给定治疗，诸如填充的次数和体积的参数条目可以在PD循环控制装置的控制面板上给出，然后该机器将根据用户输入的数据逐步执行该过程。在该过程中，该机器记录关于实际遇到的循环次数和体积的信息，并且在该记录中记录了在过程期间产生的异常或错误情况和告警。该系统被设计用于记录日期和时间并且创建患者治疗的记录。
存在几种期望与PD循环控制装置的控制系统进行数据通信的情况。首先，有关患者的数据可以被上传。这可以包括例如患者的姓名、ID、年龄、在该过程前的体重以及其它有关患者个人简档以及建议的治疗的数据。因此，患者数据的上传可以简化给定治疗的编程并且可以提供一种监视有关患者的数据的便利的方式。
其次，在治疗之后下载存储的患者记录在很多方面都是有益的。
被提供来完成此功能的是通用串行总线或USB接口，其将允许患者或医生将具有USB接口的所谓的快闪驱动存储器插入到PD循环控制装置上的USB端口，以便向PD循环控制装置的控制系统上传数据以及从PD循环控制装置的控制系统下载数据。这能够允许用户在每一治疗之后有效地下载包含在治疗期间发生的循环的次数、填充和排出警告、流速等的“数据单表”。
在上传方面，患者能够使用简单的USB快闪驱动器来将数据输入到PD循环控制装置。该数据可以存储在任何PC上。由于现在的所有PC都具有USB端口，因此极大地增强了使用的简单性和普遍性。因此，患者可以在他或她的PC上维护具有所有有关患者简档数据以及医生建议的治疗参数的文件。这个文件当前可以由患者来维护并可以包括由医生做出的处方中的修改。在一种情况中，医生使用具有标准化格式以及适当安全性的文件，以确保通过电子邮件发给患者的处方的完整性，患者于是可以存储该处方并将其传送到USB快闪驱动器，然后使用USB快闪驱动器来将数据上传到PD循环控制装置中。类似地，患者可以将有关治疗的数据单表从PD循环控制装置下载到他的快闪存储驱动上，然后将该数据单表传送到PC并将其作为e-mail的附件转发给他的医生，用于检查并作为永久记录写入日志。
图2中示出实现这个USB接口的硬件。USB连接器30能够通过标准USB 2.0端口来实现，标准USB 2.0端口位于图1所示的PD循环控制装置外罩10的背面或该循环控制装置上的任何其它方便且安全的位置。USB连接器30连接到5伏的USB电源监视器32并通过串行2-线12Mbs数据总线连接到USB 2.0控制器34。USB控制器34检测插入到端口30的快闪驱动器或其他USB设备并且通过标准协议与所述插入到端口30的快闪驱动器或其他USB设备建立通信。控制器34管理通信顺序并将数据缓冲到32位地址及数据线上或使数据从32位地址及数据线缓冲脱离。数据和地址线连接到快闪存储器36并且最好是Power PC微处理器系统MPC-823的主机微控制器38，MPC-823还能够运行PD循环控制装置的其他功能。复杂可编程逻辑器件(CPLD)40连接在微控制器38和USB控制器之间，用来根据正在发送的数据类型帮助处理数据。
用于PD循环控制装置的USB接口的一个特征在于其可以用于由用户上传可播放媒体文件，该文件可以用于培训和指导的目的。例如，这能够通过在USB快闪驱动器上将培训视频存储为MPEG文件来实现。PD循环控制装置可以配置有内置媒体播放器。因此，仅通过将快闪驱动器插入到USB端口，在CPLD 40和微控制器38的引导下，USB控制器能够使用可用的媒体播放器和用于该循环控制装置的前端的显示器12(图1)的视频驱动器，来自动地打开并播放培训视频。音频可以作为WAV文件在嵌在循环控制装置中的扬声器上播放。这是USB接口的特别有价值的用途，因为它允许在家里在用户自己的机器上进行培训并且允许医生或临床医生针对患者拥有的PD循环控制装置的具体型号指示患者要使用的正确的当前培训视频。
已经依照具体实施例描述了本发明。其他的实施例均在后面的权利要求的范围之内。例如，本发明的各步骤可以以不同的次序来执行并仍能够达到期望的结果。

Claims (4)

1.一种腹膜透析PD机，包括：
PD溶液源；
PD循环控制装置，用于将PD溶液路由并输送到需要腹膜透析的患者；
控制器，用于指示PD循环控制装置上的操作的顺序，以执行对患者的腹膜透析；以及
USB数据通信接口，包含：
在机器上的USB端口，接受USB存储器装置，以及
USB接口控制系统，用于管理来自可拆卸地部署在USB端口中的USB存储器装置的腹膜透析相关数据的检索，该数据包括由控制器使用以指示PD循环控制装置上的操作的顺序的一个或多个患者专用处方记录。
2.根据权利要求1所述的腹膜透析机，其中，所述数据还包括包含该腹膜透析机专用的培训视频的音频可视媒体文件。
3.根据权利要求1所述的腹膜透析机，其中，USB接口控制系统被配置以在治疗后将治疗数据的数字记录写入USB存储器装置上以传送到个人计算机。
4.一种与腹膜透析PD机进行数据通信的方法，该方法包括：
提供USB接口，该USB接口包含在PD机上的USB端口；和
通过向USB存储器装置传送一个或多个患者专用处方记录并将USB存储器装置插入到该USB端口中来将所述一个或多个患者专用处方记录上传到该PD机；
其中所述一个或多个患者专用处方记录被配置以指示PD机上的操作的顺序。
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CN101534878A (zh) 2009-09-16
EP2059277A1 (en) 2009-05-20
JP2013255816A (ja) 2013-12-26
EP2059277B1 (en) 2015-08-19
AU2007289206A1 (en) 2008-03-06
JP5524619B2 (ja) 2014-06-18
CA2661670A1 (en) 2008-03-06
US20080097283A1 (en) 2008-04-24
JP5838186B2 (ja) 2016-01-06
JP2010502307A (ja) 2010-01-28
US8926550B2 (en) 2015-01-06
CA2661670C (en) 2017-03-21
WO2008027967A1 (en) 2008-03-06
EP2990065A1 (en) 2016-03-02

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