CN105636620A - 盒式模块 - Google Patents

盒式模块 Download PDF

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Publication number
CN105636620A
CN105636620A CN201480044564.3A CN201480044564A CN105636620A CN 105636620 A CN105636620 A CN 105636620A CN 201480044564 A CN201480044564 A CN 201480044564A CN 105636620 A CN105636620 A CN 105636620A
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film
cassette module
functional layer
negative pressure
aforementioned
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CN105636620B (zh
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S·克雷勃
M·韦斯
M·温克
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Fresenius Medical Care Deutschland GmbH
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Fresenius Medical Care Deutschland GmbH
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    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
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Abstract

本发明涉及一种用于控制流体流的盒式模块，特别用于血液治疗系统或输液系统中，其中所述盒式模块具有至少一个第一功能层(7)和至少一个第二功能层(2)，其中，所述第一功能层(7)具有用于至少一种流体流的导流装置，并且其中所述盒式模块还具有至少两个膜(5、6)，其中第一膜(6)与用于流体流的导流装置接触，并且其中所述第二功能层(2)设置在所述两个膜(5、6)之间，并具有用于在所述膜(5、6)之间产生负压的装置(8)。

Description

盒式模块
技术领域
本发明涉及一种用于控制流体流的盒式模块，特别是用于血液治疗系统或输液系统中。
背景技术
从现有技术已知的盒式模块，例如用于特别是血液透析或腹膜透析的透析器中。借助于治疗框架内的集成功能单元，这些盒式模块有着能够控制或输送液体流，特别是血液，透析液或其它与治疗有关的液体的任务。这种功能单元是，例如，阀门，泵，通道等。血液，透析液和与治疗相关的其它液体的流动可以由其控制。
由于使用相对便宜的塑料，盒式模块可大批量生产制造且经常被用作一次性用品。
从现有技术中的盒式模块已知所述的阀门功能和泵功能。可以在盒式本体内形成能够与可移动膜接触的流道和/或开口以能够以这种方式提供所述的功能。因此可以想到，例如，使用所述膜用于泵送液体，以及依据其位置由所述膜覆盖开口等，从而提供阀门功能。
例如通过气动致动能够发生膜本身的偏转。
从EP0129554B1已知的盒式模块，其包括两个板，可移动膜设置在两个板之间。这通过气动致动控制。为了这个目的，盒式模块的板中的一个被设计为设计有通道和腔室的致动器板，根据需要能够在所述通道和腔室中产生超压或负压。
US5350357公开了能够通过在机器侧的气动致动器模块操作的盒式模块。所述盒式模块包括由膜在其前侧和后侧覆盖的基体。气动控制并因此在盒式模块内的液体流的控制可通过所述膜中之一的气动偏转而发生。
WO2008/106440A1最后公开了一种包括三个板的盒式模块，其中所述盒式模块内的液体路径基本上设置在两个外置板之间的中心板上。所需的泵功能和阀门功能能够通过各个膜产生。膜的偏转通过设置在所述板之一中的气动连接发生。
在现有技术已知的盒式模块中，由所述膜将待输送的液体与致动侧，即，与气动侧隔开。
如果发生这些膜的撕裂，这不会导致所输送液体例如血液或透析液被气动介质污染，或不会导致流经该撕裂到达盒式模块气动侧的血液或透析液的损失。
发明内容
因此，下面本发明的目的是进一步开发一种最初所述类型的盒式模块，使得减少位于所述盒式模块中的流体的污染的可能性。
所述目的通过具有权利要求1的特征的盒式模块满足。相应地提供，所述盒式模块具有至少一个第一功能层和至少一个第二功能层，其中，所述第一功能层具有至少一种流体流例如血液或透析液的导流装置，并且其中所述盒式模块还具有至少两个膜，其中第一膜与流体流的导流装置配合，并且其中所述第二功能层设置在所述两个膜之间，并具有用于在所述膜之间产生负压的装置。
根据本发明，因此提供了至少两个膜，其将能够借助盒式模块控制或输送的流体流(液体或气体)与致动器介质例如压缩空气或液体分离。
两个膜的连接由存在于两个膜之间的负压实现并避免了膜之一的非期望的定位如下垂。如果一个膜由于致动器介质如压缩空气而移动，另一膜则被相应地携带。
由真空引起的两个膜的偶合保证了，一个膜直接跟随另一膜，即两个膜在其运动进程中偶合。因此可以有效地避免负压情况下由膜下垂造成的流体通道的部分封闭。
第一功能层包括例如阀门装置或泵装置的装置，以与第一膜配合控制或调节特别是与治疗相关的液体的流动进程。
盒式模块可以有具有第三功能层，其具有用于致动所述第二膜的装置且其以这种形式与第二膜配合。所述第三功能层可以，例如，具有由于超压或负压而作用的腔室和/或流道，使得根据超压或负压是否存在而发生所述第二膜的移动，并且也由于所述的连接发生第二膜的移动。以这种方式，例如，通过泵的移动的流体输送是臆想得到的，或者还有阀门的闭合或开启等。
术语“超压”和“负压”不一定必须理解为相对于大气压力的绝对值，也可理解为相对值。
例如，在一腔室中的超压或负压因此只意味着相对于另一腔室的相对压力。由此能够想到，例如，通过操作使液体流入一腔室，由此在一腔室内产生相对于另一腔室的超压，而在另一腔室内不必须存在真空。
然而自然也可以想到，使用真空，即，相对于大气压力的负压，且也被本发明涵盖。
流体流的导流装置可以是任何所需装置，通过所述装置能够影响流体的流动。这包括，例如，一个或多个通道，阀门或泵或阀门部或泵部。
用于在膜之间产生负压的装置可包括一个或多个通道，所述通道与真空泵等连接或可与真空泵等连接。因此可以想到，例如，在机器侧提供连接到盒式模块的真空泵，使得能够在两个膜之间产生真空。
优选提供，第一膜直接接触第一功能层和第二功能层和/或第二膜直接接触第二和第三功能层。
为实现从一个膜到另一个膜的力传递的改进，可以想到，在两个膜之间存在至少一个用于改进这种力传递的装置，诸如柱塞或柱塞盘。
此外，可以提供，柱塞或具有柱塞的盘被构造为使得柱塞或盘通过第一膜在至少一个位置与导流装置配合。因此可以想到，例如，由于柱塞或柱塞板的存在，阀门可以可靠地打开或关闭。密封功能可由第一膜负责；闭合力的传递通过柱塞盘至少部分地发生。
此外，可以提供，盒式模块，特别是第二功能层，特别地在相对设置的边处具有至少两个边缘区域，所述用于在膜之间产生负压的装置向其内开口；用于产生负压的装置可以，例如，由通过在第二功能层中延伸且可以连接到真空泵等的通道形成，以便能够在膜之间实现负压。
功能层可以包括挠曲刚性材料且膜可以包括弹性材料。
所述膜是柔性的，以便一方面它们能够被致动器介质移动，另一方面，能够在流体侧进行所需的偏转。
本发明还涉及一种机器，特别是血液治疗机器或输液机，具有至少一个槽，根据权利要求1至13任一项所述的至少一个盒式模块位于其中。
所述机器，例如，可以是透析机或也可以是用于进行输液的装置。可以想到，所述透析机是血液透析机或腹膜透析机。
所述机器可以具有负压装置例如真空泵等，例如，与用于在膜之间产生负压的装置连通并在机器的操作中在那产生负压，使得所述膜尽可能地靠近彼此设置，并且其中有可能，与力传递装置接触(在所述膜之间安放了力传递装置的情况下)。
制造所述盒式模块的可以想到的方法包括使用激光辐射。在这方面，可以想到，通过使用激光器的透射焊接使膜与盒式模块的至少一个另外的构件发生连接，其中优选规定，发生了吸收激光的膜的至少一层的制热。
可以想到，所述膜具有发射激光的至少一层和吸收激光的至少一层，其中所述吸收激光的层形成所述膜对于盒式模块的至少一个另外构件的连接区域。具有激光吸收器的单层设计也被本发明所涵盖。
附图说明
将参考附图中所示的实施方式对本发明的进一步细节和优点更加详细地进行说明。
图1示出了穿过根据本发明的盒式模块的纵向剖视图。
具体实施方式
第一功能层由参考数字7标记且第二功能层由参考数字2标记。
参考数字1标记第三功能层。
如能够从图中所看出，第二功能层2位于第一功能层7和第三功能层1之间。
此外，第一膜6位于第二功能层2和第一功能层7之间且第二膜5位于第三功能层1和第二功能层2之间。
参考数字8标记真空通道，其穿过第二功能层2延伸，并且其具有提供或保持两个膜5，6之间的真空的目的。
如能够进一步从所述图中所看出，所示两个腔室中的各自的一个柱塞或各自的一个活塞板3位于膜5,6之间，其同等地充当用于闭合或释放第一功能层7中的开口70，70’的阀门。
在盒式模块插入到机器内的状态下，真空通过机器的真空泵等施加到通道8，以使两个膜5,6彼此紧密接触或紧密接触柱塞或柱塞板3。
如能够进一步从图所看出，用于至少一个液体流，如血液，透析液，输液等的导流装置位于第一功能层7内，其中在此处示出的实施方式中，所述装置以阀门的形式配置，其允许或阻止流过盒式模块的腔室14，14’。
如能够进一步从图所看出，阀门块或设计为阀门块的盒式模块具有两个这样的阀门，其中，在左边示出的在盒式模块的腔室14中具有开口70的阀门是打开的，且在右边示出的在盒式模块的腔室14’中具有开口70’的阀门是关闭的。
由于如箭头所示负压产生在气动腔室12内，发生阀门的打开。这导致，第二膜5，由于膜之间存在真空，还有第一膜6及柱塞板3被向上移动，由此开口70被膜6释放。因此，使穿过流体腔室14的流体流成为可能。如上所述，术语超压和过压不一定意味着相对于大气压力的绝对值，而是也可以被理解为相对于彼此的值。
因此可以想到，例如，在腔室12内的负压并不仅仅意味着经由泵在腔室内施加真空。也可以意味着通过盒的操作使液体流入腔室14内，然而并没有在腔室12内发生针对此的致动。
在这种情况下膜5,6也被偏转且，腔室12表示相对于腔室14的负压侧，而并非必须在腔室12内存在真空。
在功能层2中的压力低于在层1和14中的压力。
与此相反，在左侧示出的盒式模块的腔室12’中产生超压，如所示箭头所表征的，其表示了气动流体(特别是压缩空气)的流入。在右侧示出的两个膜5,6以及柱塞板3是由此被向下致动且开口70’借由第一膜6被关闭。因此腔室14’能够不被流体流过，如虚线箭头所示。
在图中所示的盒式模块是阀门块。任何所需的其它功能，诸如泵功能等，一般也由本发明所涵盖。
功能层1，2，7包括挠曲刚性塑料，即稳定形状的塑料，而膜5,6被设计为柔性的，优选弹性膜，使得能够设置所需的导流。
能够进一步从图看出，第一功能层7和第三功能层1都具有形成腔室12，14，12’，14’的展开部，所述腔室一方面，用于通过致动器介质如压缩空气控制膜以及，另一方面，用于控制流体流，如血液，透析液，输注液等。
所示出的盒式模块自然不仅适于控制液体流，而且，例如，适于控制气体流。
经由腔室12，12’的控制，也并不一定要使用气体或压缩空气发生，而是可以同样地经由流体，即液压地发生。
在腔室12，12’中，所示阀门或柱塞板3经由超压或负压到达一个或另一个端位置处并且依据其即时位置以其与气动系统或液压系统相对的一侧来关闭或打开流路或开口70，70’。
所述端位置能够，例如，通过表面或功能层，例如通过第二功能层形成。在右腔室中，柱塞板的板状区域抵接第二功能层，使得由此限定端位置。
控制回路，例如气动回路，和流路，例如用于输送血液，透析液等的回路，通过两个膜5,6的存在被可靠地分离，以使在膜撕裂时没有污染发生。
由于事实上在膜5,6之间存在真空并因此一个膜跟随另一个膜的移动，当负压存在于流体侧时，即在腔室14，14’侧或开口70，70’侧时，也能够实现阀门和开口70，70’的可靠打开。否则，可能发生如下情况，在阀门被关闭并施加负压下，通道70，70’不再能够通过在腔室12，12中施加负压而打开。
两个膜5,6优选仅通过施加负压而彼此连接。
膜5优选与功能层1和2直接接触且该膜优选与功能层2和7直接接触。
通常还可以提供附加的连接装置，例如焊接，经由其所述膜能够彼此连接。然而，本发明的一个优选的实施方案包括完全摈弃该指定焊接。
至少一个传感器被优选地提供在通道8中或与其连接的线元件中且所述传感器可以测量压力和/或在通道中的流量。因此，优选由机器，特别优选在升级(updrading)之后和仍在治疗开始之前，有可能能够在早期阶段识别膜5或膜6或两个膜的破裂。然而，破裂也能够通过连接到所述功能层的真空泵装置的可变功率提取而识别。
如果例如，发现所需的真空不能在通道8中被保持，因此也不会在位于膜之间的区域5,6中被保持，这可能是由于事实上在膜5,6的一个或两者中都存在破裂。在这种情况下，优选将盒式模块设计为一次性用品以用功能模块替换。
在这一点上指出，术语“膜”被广泛理解并涵盖可进行所述功能的任何面积的和可动材料。膜能够，例如，被配置为薄膜。
它们优选为不渗透流体或也不渗透致动器介质。而且还优选对气体大体上不透过，以使真空可以容易地维持。
本发明的进一步的优点包括：所示阀门功能的安全性，在膜5，6的连接上焊接缺陷有可能存在时也得以提高；在负压的情况下不存在经由膜下垂引起的流体通道的部分封闭，以及能够完全省去膜至阀门的焊接工艺。
由于位于膜5,6之间的柱塞盘3，由第二膜5施加的阀门功能或运动更快且更精确地发生。这使得阀门切换的时钟率更高，这是所希望的。

Claims (15)

1.一种用于控制流体流的盒式模块，特别用于血液治疗系统或输液系统中，其中所述盒式模块具有至少一个第一功能层和至少一个第二功能层，其中，所述第一功能层具有用于至少一种流体流的导流装置，并且其中所述盒式模块还具有至少一个第一和一个第二膜，其中第一膜与所述用于流体流的导流装置配合，并且其中所述第二功能层设置在所述两个膜之间，并具有用于在所述膜之间产生负压的装置。
2.根据权利要求1所述的盒式模块，其特征在于，所述盒式模块具有第三功能层，其具有用于致动所述第二膜的装置且与所述第二膜配合。
3.根据权利要求2所述的盒式模块，其特征在于，所述用于致动第二膜的装置是气动装置或液压装置，特别是其中存在或能够产生超压或负压的腔室或通道。
4.根据前述权利要求任一项所述的盒式模块，其特征在于，所述用于流体流的导流装置具有一个或多个通道，阀门部和泵部。
5.根据前述权利要求任一项所述的盒式模块，其特征在于，用于在所述膜之间产生负压的装置包括一个或多个通道或由一个或多个通道组成，所述通道连接到真空泵或能够与真空泵连接。
6.根据前述权利要求任一项所述的盒式模块，其特征在于，所述第一膜直接或间接地接触所述第一功能层且所述第一和第二膜直接或间接地接触所述第二功能层。
7.根据权利要求2-6任一项所述的盒式模块，其特征在于，所述第二膜直接或间接地接触所述第二和第三功能层。
8.根据前述权利要求任一项所述的盒式模块，其特征在于，在所述第一膜和/或第二膜中和/或在所述两个膜之间存在至少一个用于改进从一个膜到其它膜的力传递的装置。
9.根据权利要求8所述的盒式模块，其特征在于，所述装置是至少一个柱塞或连接到柱塞的至少一个盘。
10.根据权利要求9所述的盒式模块，其特征在于，所述柱塞或具有柱塞的盘被构造成使其与所述用于流体流的导流装置在至少一个位置处配合。
11.根据前述权利要求任一项所述的盒式模块，其特征在于，所述盒式模块具有至少两个边缘区域，特别是彼此相对或相邻设置的边，所述用于在膜之间产生负压的装置向其内开口；和/或在于所述盒式模块具有至少一个用于测量所述膜之间存在的压力的传感器。
12.根据前述权利要求任一项所述的盒式模块，其特征在于，至少一个，多个或全部功能层包括挠曲刚性材料，优选塑料。
13.根据前述权利要求任一项所述的盒式模块，其特征在于，所述第一和/或第二膜是弹性膜。
14.一种机器，特别是一种血液治疗机或输液机，具有至少一个槽，根据权利要求1至13任一项的至少一个盒式模块位于其中。
15.根据权利要求14所述的机器，其特征在于，所述机器具有负压装置，其与用于在所述膜之间产生负压的装置连通，且在机器运转中在那产生负压；和/或在于至少一个传感器存在于机器侧和/或盒式模块侧，用于测量所述膜之间的压力或与其相关的参数。
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US20160184502A1 (en) 2016-06-30
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CN105636620B (zh) 2018-09-18
US10926015B2 (en) 2021-02-23
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