CN113348002A - 用于体外的血液治疗的设备 - Google Patents
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Abstract
本发明涉及一种用于体外的血液治疗的设备，其具有：体外的血液回路，在体外的血液回路中设置有透析器；以及透析液回路，其中血液回路与透析器的第一腔室流体连通而透析液回路与第二腔室流体连通，并且其中这两个腔室通过半透膜彼此分开，其中在透析液回路中存在用于输送透析溶液的透析液泵，其中所述设备具有控制单元，所述控制单元构成为，使所述设备在第一阶段和跟随第一阶段的第二阶段中运行，其中所述透析液泵在第一阶段中与在第二阶段中相比以更低的流速运行，和/或其中所述透析液泵在第一阶段中与在第二阶段中相比输送关于至少一种组分浓度更高的透析溶液。
Description
技术领域
本发明涉及一种用于体外的血液治疗的设备，所述设备具有：体外的血液回路，在所述体外的血液回路中设置有透析器；以及具有透析液回路，其中所述血液回路与透析器的第一腔室流体连通，并且所述透析液回路与透析器的第二腔室流体连通，并且其中这两个腔室通过半透膜相互分开，其中在透析液回路中存在用于输送透析溶液的透析液泵。
背景技术
这种设备用于从患者的血液中去除尿液物质，所述尿液物质经由透析器的膜进入透析溶液中并且以这种方式从患者的血液中去除。
从EP 0 942 759 B1中已知具有权利要求1的前序部分的特征的设备。在从该文献中已知的设备中，提出，在治疗期间将实际的透析效率(K/V)近似为对于患者仍可忍受的最大透析效率(K/V)max的值，也就是说，从一开始就以尽可能高的效率进行治疗，以便能够将治疗时长保持为尽可能地短。当达到规定的透析剂量(K.t/V)时，结束治疗，其中t是治疗时长，K是清除率，V是患者的分布体积。
在透析时，由于电解质或其余物质，例如钾离子或尿素从血液中转移到透析溶液中，可能会发生并发症，所述并发症引起如头痛、呕吐等不适，这也作为失衡综合症已知。
发明内容
本发明所基于的目的是，如下改进一种开始提及的类型的设备：与已知的设备相比，降低出现这种并发症的可能性和/或并发症的严重性。
所述目的通过具有权利要求1的特征的设备来实现。
据此提出，所述设备具有控制单元，所述控制单元构成用于，使所述设备在第一阶段中和跟随第一阶段的第二阶段中运行，其中透析液泵在第一阶段中与在第二阶段中相比以较低的流速运行，和/或其中透析液泵在第一阶段中与在第二阶段中相比输送关于至少一种组分浓度更高的透析溶液。
第二阶段优选紧接着第一阶段。然而，本发明包括第二阶段的开始与第一阶段的结束在时间上间隔开的情况。
因此，本发明所基于的构思是，在治疗开始时与在治疗的之后的时间点相比选择更低的透析液流量，或者在治疗开始时与在治疗的之后的时间点相比使用关于一种或多种物质浓度更高的透析溶液。优选地，所述一种或多种物质是也存在于血液中的物质，例如钠离子等。
通过这两种措施实现：在治疗开始时从血液中相对较慢地提取尿液物质，这使得患者对治疗的忍受性提升，并且显著降低出现失衡综合征的可能性或症状的严重性。因此，并非从一开始就达到或设定透析溶液的所规定的流速或浓度，而是仅在治疗的之后的时间点，例如在30分钟之后才达到或设定。
如果在第一阶段中设定相对低的透析液流量，那么物质从血液相应较慢地扩散转移到透析溶液中。这相应适用于如下情况：最初将也存在于血液中并且在其中待耗尽的组分的浓度在透析溶液中设定地高，使得在血液和透析溶液之间的浓度梯度低，这同样引起从血液中离开的最初低的扩散速率。
控制单元能够构成为，使得在第一阶段和/或第二阶段中的流速和/或浓度是恒定的或者改变，其中所述改变优选线性地、指数地或分级地发生。原则上，流速和/或浓度的任何曲线化都包含在本发明中。
可考虑的是，仅在第一阶段中进行透析溶液的至少一种物质的流速和/或浓度的固定预设的或者与一个或多个参数相关的曲线化，并且在第二阶段中与在第一阶段中相比根据不同的标准来设定透析溶液的至少一种物质的流速和/或浓度，例如根据测量值，例如所测量到的清除率。
控制单元能够设计为，使得仅在第一阶段中、仅在第二阶段中或者在第一阶段和第二阶段中改变透析溶液的流速和/或透析溶液中所提及的(多种)组分的浓度。可考虑的是，透析设备在第一和/或第二阶段中以关于透析溶液的恒定的流速和/或浓度运行。
可考虑的是，控制单元构成为，使得在第二阶段中不改变透析溶液的流速和/或不改变透析溶液的浓度。
控制单元能够构成为，使得第一阶段在15分钟至60分钟的时间段内延伸，优选在20分钟至40分钟的时间段内延伸，并且特别优选在30分钟的时间段内延伸。
显然，前述值是不限制本发明的示例。
控制单元能够构成为，在第一阶段之前存在例如5分钟至10分钟时长的调节阶段，在所述调节阶段中不进行透析，而是仅进行血液滤过。因此，在能够表示治疗开始的该阶段中，由于在膜上的压降，仅存在对流清除，但是不存在扩散清除。
在该调节阶段之后于是立即或在时间上与其间隔开地进行治疗的第一阶段。这种调节阶段例如从DE 10 2016 008 755 A1中已知，其公开内容就此成为本发明的主题。
第一阶段的时长对于所有患者能够是恒定的，或者与一个或多个治疗参数和/或患者参数例如患者的体重和/或分布体积和/或血液中的物质浓度例如透析前尿素浓度相关。第二阶段的时长优选取决于：何时达到所规定的透析剂量。
控制单元能够构成为，在第二阶段中，根据在治疗期间求取的清除率或所达到的透析剂量来设定流速和/或浓度。因此可考虑在线清除率监测，即实时进行的清除率测量，并且根据其设定透析溶液的流速和/或浓度。
也可考虑的是，在开始治疗之前或在开始治疗时设定特定的曲线以设定透析溶液在第一和/或第二阶段内的流速和/或浓度，所述曲线然后由所述控制单元并且与任何测量值无关地遍历。
从第一阶段到第二阶段的过渡能够关于浓度和/或透析液流量连续地或分级地进行。例如可考虑的是，在第一阶段中设定透析溶液的特定的第一流速和/或浓度，而在第二阶段中或者至少在第二阶段开始时或者持续地设定透析溶液的第二流速和/或浓度，使得产生阶梯状过渡。
然而，关于透析溶液的流速和/或浓度从第一阶段到第二阶段的连续的过渡也包含在本发明中。
控制单元能够构成为，使所述设备作为血液透析设备或作为血液透析滤过设备运行。换言之，所述设备能够是血液透析设备或血液透析滤过设备。可考虑的并且也包含在本发明中的是如下情况：所述设备有时作为纯血液滤过设备运行，即在透析器中不存在透析溶液。
同样可考虑的是，所述设备具有用于置换流体的一个或多个管线，所述置换流体仅在透析器的上游、仅在下游或既在上游也在下游添加给血液。在此，控制单元能够构成为，在第一阶段中于在第二阶段中相比将置换溶液的流量设定得更低。例如可考虑的是，使所述置换溶液的流量从在治疗开始时的零值升高到规定值和/或根据透析溶液的流速来设计置换速率。
关于这一点要指出的是，术语“一”和“一个”不一定指代元素中的恰好一个，虽然这是一种可能的实施方案，而是也能够指代多个元素。同样地，复数的使用也包括所提及的元素以单数的形式存在，并且相反，单数也包括多个所提及的元素。
本发明的更多细节和优点从在附图中示出的实施例中得出。
附图说明
唯一的附图示出在根据本发明的设备中透析溶液的流速关于时间的变化。
具体实施方式
在纵坐标上示出流过透析器的透析溶液的流速而在横坐标上示出时间。
如从附图中得知的那样，在调节阶段(点A)之后，在第一阶段P1中，流过透析器的透析溶液的流速升高，其中所述升高在第一阶段中随着时间增加而变小，在所述调节阶段中不进行扩散传质，而是仅进行血液经由膜进入透析溶液中的对流传质。
在附图中的竖直线表示在第一阶段和第二阶段之间的边界。在第二阶段P2中，透析溶液的流速高于在第一阶段中的流速并且是基本恒定的。
如从附图中所看到的那样，流速的变化过程的从第一阶段到第二阶段的过渡连续且无分级地进行。
在第一阶段P1中，将流速的变化曲线化，其中该曲线能够固定地预设，或者能够与一个或多个参数相关，例如患者的状态、患者的体重、其分布体积等。
在第二阶段P2中，根据在第二阶段中测量到的清除率K(OCM controlledclearance modeling，OCM受调节的清除率建模)和/或根据所规定的治疗时间或者根据所规定的期望值或期望值曲线来设定透析溶液的流速，在所述治疗时间中必须达到特定的透析剂量。
如从附图中所得知的那样，在治疗开始时，由于所产生的不平衡和与其相关的结果，有针对性地防止快速去除盐、尿素等，其方式为：设定相对小的透析液流量。也就是说，透析液的真实所规定的流速不通过透析液泵的尽可能快的高速运转来实现，而是通过缓慢地提升流速而有意地在时间上延迟地实现。
如从附图中所得知的那样，在第二阶段中能够分级地或连续地达到所述流速。
也能够如下实现在治疗开始时相对于之后的治疗更缓慢地排出尿液物质：在治疗开始时与在之后的治疗时间点相比使用不同的透析溶液。因此也能够实现所提及的物质在血液中的浓度最初较小的减小而之后较大的减小。在该方法途径中可考虑的是，使用不同的透析溶液，所述透析溶液存放在不同的袋等中，或者一种或多种内含物的浓度在透析溶液的同一储液器中线性地或分级地变化。
Claims (11)
1.一种用于体外的血液治疗的设备，所述设备具有：体外的血液回路，在所述体外的血液回路中设置有透析器；以及透析液回路，其中所述血液回路与所述透析器的第一腔室流体连通并且所述透析液回路与所述透析器的第二腔室流体连通，并且其中这两个腔室通过半透膜彼此分开，其中在所述透析液回路中存在用于输送透析溶液的透析液泵，其特征在于，所述设备具有控制单元，所述控制单元构成用于，使所述设备在第一阶段和跟随所述第一阶段的第二阶段中运行，其中所述透析液泵在第一阶段中与在第二阶段中相比以更低的流速运行，和/或其中所述透析液泵在第一阶段中与在第二阶段中相比输送关于至少一种组分浓度更高的透析溶液。
2.根据权利要求1所述的设备，其特征在于，所述控制单元构成为，使得所述流速和/或所述浓度在所述第一阶段和/或所述第二阶段中是恒定的或者改变，其中所述改变优选线性地、指数地或分级地发生。
3.根据权利要求2所述的设备，其特征在于，所述控制单元构成为，使得仅在所述第一阶段中或者既在所述第一阶段也在所述第二阶段中改变所述流速和/或所述浓度。
4.根据上述权利要求中任一项所述的设备，其特征在于，所述控制单元构成为，使得在所述第二阶段中不改变所述流速和/或不改变所述浓度。
5.根据上述权利要求中任一项所述的设备，其特征在于，所述控制单元构成为，使得所述第一阶段在15分钟至60分钟的时间段内延伸，优选在20分钟至40分钟的时间段内延伸，并且特别优选在30分钟的时间段内延伸。
6.根据上述权利要求中任一项所述的设备，其特征在于，所述控制单元构成为，使得在所述第一阶段之前存在调节阶段，在所述调节阶段中不进行透析，而是仅进行血液滤过。
7.根据上述权利要求中任一项所述的设备，其特征在于，所述控制单元构成为，使得所述第一阶段的时长与一个或多个治疗参数和/或患者参数相关。
8.根据权利要求7所述的设备，其特征在于，所述患者参数是患者的体重和/或分布体积和/或血液中的物质浓度例如透析前的尿素浓度。
9.根据上述权利要求中任一项所述的设备，其特征在于，所述控制单元构成为，使得在所述第二阶段中，根据在治疗期间所求取的清除率或所达到的透析剂量来设定所述流速和/或所述浓度。
10.根据上述权利要求中任一项所述的设备，其特征在于，所述控制单元构成为，使得连续地或分级地进行关于所述浓度和/或所述透析液流量的从所述第一阶段到所述第二阶段的过渡。
11.根据上述权利要求中任一项所述的设备，其特征在于，所述控制单元构成用于，将所述设备作为血液透析设备或作为血液透析滤过设备运行并且可选地有时作为血液滤过设备运行。
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4722798A (en) * | 1981-06-11 | 1988-02-02 | Baxter Travenol Laboratories, Inc. | Hemodialysis with dialysate osmolarity varied non-linearly with time |
| EP0613688A1 (de) * | 1993-02-19 | 1994-09-07 | Wilfried Dr.-Ing. Schäl | Verfahren zur Bereitung von bicarbonathaltigen Dialysierflüssigkeiten für die Hämodialyse |
| US20130327713A1 (en) * | 2012-06-06 | 2013-12-12 | Fresenius Medical Care-DS, s.r.o. | Apparatus for extra-corporeal blood treatment and method of presetting an initial mode of treatment for an extra-corporeal blood treatment apparatus |
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| SE9604370D0 (sv) | 1996-11-28 | 1996-11-28 | Gambro Ab | Method and system for preventing intradialytic symptomatology |
| DE19928407C1 (de) | 1999-06-22 | 2000-10-26 | Fresenius Medical Care De Gmbh | Verfahren zur Bestimmung der Leistungsfähigkeit eines Dialysators einer Dialysevorrichtung und Dialysevorrichtung zur Durchführung des Verfahrens |
| DE102008003714A1 (de) | 2008-01-09 | 2009-07-16 | Fresenius Medical Care Deutschland Gmbh | Verfahren zum Bestimmen des Anteils der Rezirkulation in einer Fistel und/oder der kardiopulmonalen Rezirkulation an der Summe von Fistelrezirkulation und kardiopulmonaler Rezirkulation |
| JP5359822B2 (ja) | 2009-11-30 | 2013-12-04 | ニプロ株式会社 | 血液透析装置 |
| DE102016008755B4 (de) | 2016-07-18 | 2024-06-06 | Fresenius Medical Care Deutschland Gmbh | Dialysegerät mit einer Steuereinheit zur Durchführung einer Konditionierung der Dialysemembran |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4722798A (en) * | 1981-06-11 | 1988-02-02 | Baxter Travenol Laboratories, Inc. | Hemodialysis with dialysate osmolarity varied non-linearly with time |
| EP0613688A1 (de) * | 1993-02-19 | 1994-09-07 | Wilfried Dr.-Ing. Schäl | Verfahren zur Bereitung von bicarbonathaltigen Dialysierflüssigkeiten für die Hämodialyse |
| US20130327713A1 (en) * | 2012-06-06 | 2013-12-12 | Fresenius Medical Care-DS, s.r.o. | Apparatus for extra-corporeal blood treatment and method of presetting an initial mode of treatment for an extra-corporeal blood treatment apparatus |
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| EP3914315A1 (de) | 2021-12-01 |
| AU2020211019A1 (en) | 2021-09-23 |
| DE102019101774A1 (de) | 2020-07-30 |
| JP7476212B2 (ja) | 2024-04-30 |
| JP2022518042A (ja) | 2022-03-11 |
| US20220096720A1 (en) | 2022-03-31 |
| WO2020152333A1 (de) | 2020-07-30 |
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