EP4221776A1 - Dispositif destiné à la production d'un concentré de dialyse - Google Patents

Dispositif destiné à la production d'un concentré de dialyse

Info

Publication number
EP4221776A1
EP4221776A1 EP21790386.3A EP21790386A EP4221776A1 EP 4221776 A1 EP4221776 A1 EP 4221776A1 EP 21790386 A EP21790386 A EP 21790386A EP 4221776 A1 EP4221776 A1 EP 4221776A1
Authority
EP
European Patent Office
Prior art keywords
mixing
value
designed
mixing process
optimization
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP21790386.3A
Other languages
German (de)
English (en)
Inventor
Patrick BEßLER
Stefan EBERLEIN
Andreas HEMM
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Vivonic GmbH
Original Assignee
Vivonic GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Vivonic GmbH filed Critical Vivonic GmbH
Publication of EP4221776A1 publication Critical patent/EP4221776A1/fr
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • 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
    • A61M1/1654—Dialysates therefor
    • A61M1/1656—Apparatus for preparing dialysates
    • A61M1/1666—Apparatus for preparing dialysates by dissolving solids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3327—Measuring
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3368—Temperature

Definitions

  • the present invention relates to a device for producing a dialysis concentrate, the device having an inlet for solvent and a receptacle for a concentrate raw material to be dissolved or mixed with the solvent, and a mixing container for mixing solvent and concentrate raw material.
  • the main parameters that influence the mixing process are: 1. Mechanical energy, such as that introduced by stirring, operating pumps, etc.,
  • Thermal energy such as the dialysis water temperature, the mixture temperature, the operation of a heater, etc.
  • the framework conditions of dialysis water temperature, ambient temperature, required date, etc. are in turn dependent on many other framework conditions.
  • Dialysis water is metered into a mixing container 2 of the mixing system 6 by means of the dialysis water inlet 1 . Furthermore, the concentrate raw material is dosed manually or automatically in individual components or pre-dosed containers. In the mixing container 2, mixing takes place using one or more mixing methods, such as stirring, circulation or any other mixing method. Mixture of concentrate raw material with dialysis water and thus the production of the dialysis concentrate.
  • the dialysis concentrate being produced is fed to the measuring device 3 by means of the pump 4 for the purpose of quality control for process control or for release before the end of the mixing process. It is possible for a reference liquid, such as dialysis water, to be supplied to the measuring device before and/or after each of these mixing processes, so that an automatic process for revalidating or calibrating the measuring device 3 can take place.
  • the object of the present invention is to improve a device and a method for producing dialysate concentrate so that the production of the dialysis concentrate is resource-saving.
  • the device has a controller or a controller unit, which comprises the following: a parameter unit, which is designed to record or determine at least one input parameter value, an optimization unit, which is used to determine an optimization of the mixing process of concentrate raw material and solvent based on the at least one input parameter value, and a control or regulation unit, which is designed to control or regulate the manufacturing process of the device using one or more output parameter values based on the determined optimization.
  • a controller or a controller unit which comprises the following: a parameter unit, which is designed to record or determine at least one input parameter value, an optimization unit, which is used to determine an optimization of the mixing process of concentrate raw material and solvent based on the at least one input parameter value, and a control or regulation unit, which is designed to control or regulate the manufacturing process of the device using one or more output parameter values based on the determined optimization.
  • one or more input parameters are taken into account, such as, for example, one or more environmental parameters, such as the temperature, etc., and an optimization of the production process is carried out on the basis of these.
  • the production process is controlled or regulated by means of one or more output parameters, such as the duration of the mixing process, its start, etc. If there is regulation, the controller is designed to carry out the mixing process in such a way that a target value is achieved as far as possible, such as a specific target duration, specific target costs or a specific capacity.
  • the parameter unit can be designed to receive the at least one input parameter value from a sensor, from a database or other data source or by manual input by the user.
  • the parameter unit can thus either receive one or more input parameter values, such as from one or more sensors, such as temperature sensors, or by input from a user. In the latter case, the parameter unit thus has an interface for a user, such as a keyboard. It is also possible for the parameter unit to be designed to determine the input parameter(s) itself, for example based on historical values or generally by means of a prediction, e.g. by predicting the ambient temperature.
  • the device may include a measuring device, such as a sensor, for determining at least one input parameter value.
  • a measuring device such as a sensor
  • This can include, for example, the temperature of the ambient air, the dialysis water supplied, etc., or the solution in the mixing container.
  • the measuring device can preferably be connected to the mixing container by a line system provided with a pump.
  • the inlet for the solvent is a dialysis water inlet. It is dialysis water preferably water that has been cleaned by a filtration process, the water being the permeate of the filter.
  • the receptacle for the concentrate raw material can be formed by the mixing tank itself.
  • the concentrate raw material to be dissolved or mixed is placed in the mixing container.
  • the receptacle is formed by a component of the device that is different from the mixing container.
  • the concentrate raw material can be a dry concentrate or a liquid concentrate or a slurry-form concentrate raw material.
  • the “mixing of a concentrate raw material with a solvent” is therefore to be understood as a pure mixing process and/or a dissolving process.
  • the optimization unit is preferably designed in such a way that it carries out the optimization of the mixing process using a computer-aided analysis method and/or optimization method. Examples include neural networks, correlations, machine learning, etc.
  • the controller can be designed to influence or provide one or more of the following output parameters during control or regulation: time of dialysis water dosing, time between dosing and the mixing process, time of initiating the mixing process, duration of the mixing process, proportions of mechanical, electrical and /or thermal energy. These or other output parameters are then applied to the mixing process.
  • the parameter unit can be designed to receive a target value for an optimization parameter to be optimized, with the controller also being designed to control or regulate the mixing process in such a way that the target value is obtained in full or within a certain deviation.
  • Conceivable optimization parameters are the production costs, the production time or the capacity. In the latter case, an optimization is carried out with regard to how much dialysis water is available and/or when a point in time for the dialysis concentrate is required.
  • the parameter unit is designed to record or determine a sensor value and/or a value entered by the user and/or a value determined by prediction as the input parameter value.
  • the present invention also relates to a method for producing a dialysis concentrate, the method comprising mixing a concentrate raw material with a solvent in which the concentrate raw material is soluble or with which the concentrate raw material is miscible, and based on one or more input parameter values an optimization of the Mixing process is carried out.
  • the optimization can be carried out as open-loop or closed-loop control.
  • the input parameter value can be a measured value, a value entered by the user or a determined value.
  • the determined value can be, for example, a value determined by prediction or a predicted value.
  • the optimization preferably supplies one or more output parameter values, which are then used in the course of producing the dialysis concentrate.
  • the output parameters can form one or more of the following parameters: time of dialysis water dosing, time between dosing and the mixing process, time of initiation of the Mixing process, duration of the mixing process, proportions of mechanical, electrical and/or thermal energy.
  • the method according to the invention is preferably carried out by means of a device according to the invention.
  • the present invention further relates to a system comprising a device according to one of Claims 1 to 8 and a blood treatment device, the device being a component part of the blood treatment device or being fluidically connected to it.
  • the blood treatment machine is preferably a dialysis machine.
  • the figure shows a device for the production of dialysis concentrate according to the invention.
  • the mixing system 6 described in more detail above as an example is connected to a controller 5 or the controller 5 is part of the mixing system 6.
  • the controller 5 is designed to record and analyze measured values and based on this to influence or optimize the mixing process.
  • the mixing process optimized by the controller 5 is then implemented by the mixing system 6 using one or more output parameter values.
  • the controller 5 generally stands for any hardware and/or software-based hardware and/or software unit.
  • the controller 5 can be designed to receive data from the mixing system 6 and/or other data, such as environment data or environmental data, which are identified by the reference numeral 7 in the figure. This can be, for example, the dialysis water temperature, the ambient temperature, the temperature of the solution and/or data from other systems, etc.
  • the controller 6 collects and processes this data. Based on this data, it determines the optimal mixing process for the production of a dialysis concentrate.
  • the controller 6 optimizes the mixing process using one, several or all control options.
  • These control options i.e. output parameter values, can, for example, be one or more of the following:
  • Time of the mixing process (energy costs) • Optimization of the proportions of mechanical energy, electrical energy, thermal energy and/or mixing time in the mixing process.
  • the controller 6 can be designed to optimize the mixing process with regard to one or more variables.
  • One or more of the following target values are conceivable as target values:
  • the controller can be designed to forecast the framework conditions for the mixing process and to control the mixing process based on the forecast. This prognosis can be made, for example, on the basis of the following data:
  • Forecast data such as the weather forecast affecting the inlet water temperature and/or affecting the ambient temperature
  • Seasonal Profiles Information on different concentrate raw materials, such as grain size, different compositions of the individual components of the concentrate raw material.
  • Input parameters or their values for the optimization process can be transferred to the controller via an interface. It is possible for the controller to be designed in such a way that the input parameter values are entered via a user interface or determined and/or provided by a sensor. Alternatively or additionally, it is possible for the data to be used via an interface from any database or data source. For example, input parameter values from historical and/or current values and/or from prediction systems for the future are conceivable, which provide certain future values by prediction.
  • the values can be historical, current or estimated values or sensor signals, such as temperature, pressure, flow, consumption, prices and availability of energy, media properties, composition, particle size, properties of the starting material(s), etc.
  • One or more optimization goals can be transferred to the controller via an interface, such as the required time for the completion of the concentrate, the energy consumption for the concentrate production, the time or duration of the production process, the total costs for the production, etc.
  • the controller determines the parameters and their values of the manufacturing process, by means of which the target can be achieved and controls the mixing process accordingly.
  • a scheme is also conceivable, to the effect that one or more values are reported back to the controller during the manufacturing process and the Controller carries out a comparison between the actual value and the target value. If a deviation is determined, the controller can be designed to influence the production process, ie the mixing process, in such a way that the difference is minimized or assumes the value zero.
  • the controller 5 can, for example, optimize the mixing process of the mixing or preparation system using computer-aided analysis methods and/or optimization methods such as correlations, neural networks, machine learning etc. This can involve, for example, lengthening or shortening the mixing time, adjusting the temperature during the mixing process, controlling and supplying energy, such as mechanical energy, to the mixing process. In this way, the controller 5 can evaluate and ensure the required quality of the dialysis concentrate.
  • the controller 5 receives one or more data or input parameters, i.e. actual values of parameter values, either by input or by retrieval.
  • This can be data from databases, manually entered data or sensor data.
  • Example data are:
  • Forecast data such as weather forecasts that affect the temperature of the inlet water or the ambient temperature •
  • Daily profiles of the dialysis water temperature and/or the ambient temperature such as water consumption, heating control, individual profiles of the treatment centers,
  • the controller can use computer-aided analysis methods such as correlations, neural networks, machine learning, etc. with regard to one or more specified goals, such as costs, time or duration, capacity (e.g. availability of dialysis water and/or the time when the dialysis concentrate is required) to optimize the process carry out.
  • computer-aided analysis methods such as correlations, neural networks, machine learning, etc. with regard to one or more specified goals, such as costs, time or duration, capacity (e.g. availability of dialysis water and/or the time when the dialysis concentrate is required) to optimize the process carry out.
  • Time of the mixing process (energy costs) • Optimization of the proportions of mechanical energy, electrical energy, thermal energy and/or mixing time in the mixing process.
  • the parameter(s) optimized for the mixing process or the output parameter values are transferred to the mixing system 6 or the controller 5 carries out the mixing process based on these parameters.
  • the mixing process preferably takes place by control or regulation by means of the controller 5.
  • the mixing process takes place using the optimized parameters, with the mixing process preferably taking place as described at the outset with regard to the prior art.
  • the parameters of the manufacturing process for the dialysis concentrate no longer have to be designed for the worst case, such as low temperatures, high energy costs, etc. Rather, according to the invention, the parameter or parameters of the manufacturing process for the dialysis concentrate are adapted to the historical, current or future circumstances, so that resources can be conserved.
  • the mixing process can be adapted to the historical, current or future circumstances. It is also possible to mix the mixing process with a process that is specifically adapted to this situation in phases where the basic conditions are optimal, such as temperature etc.
  • the communication between different devices is a further optimization of the overall process to enable dialysis treatment and the associated conservation of resources possible.

Landscapes

  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Urology & Nephrology (AREA)
  • Anesthesiology (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Emergency Medicine (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • External Artificial Organs (AREA)

Abstract

La présente invention concerne un procédé et un dispositif pour la production d'un concentré de dialyse, le dispositif comprenant une arrivée pour le solvant ainsi qu'un élément de réception pour une matière première de concentré, à dissoudre au moyen du solvant ou miscible avec le solvant, et un récipient de mélange permettant de mélanger le solvant et la matière première de concentré, ledit dispositif étant en outre pourvu d'un contrôleur qui comprend une unité de paramètres conçue pour recevoir ou déterminer au moins une valeur de paramètre d'entrée, une unité d'optimisation conçue pour déterminer une optimisation du processus de mélange sur la base de ladite au moins une valeur de paramètre d'entrée, et une unité de commande ou de régulation conçue pour commander ou réguler le processus de fabrication du dispositif au moyen d'une ou de plusieurs valeurs de paramètre de sortie sur la base de l'optimisation déterminée.
EP21790386.3A 2020-10-01 2021-09-30 Dispositif destiné à la production d'un concentré de dialyse Pending EP4221776A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102020125648.5A DE102020125648A1 (de) 2020-10-01 2020-10-01 Vorrichtung zur Herstellung eines Dialysekonzentrats
PCT/EP2021/076909 WO2022069612A1 (fr) 2020-10-01 2021-09-30 Dispositif destiné à la production d'un concentré de dialyse

Publications (1)

Publication Number Publication Date
EP4221776A1 true EP4221776A1 (fr) 2023-08-09

Family

ID=78087329

Family Applications (1)

Application Number Title Priority Date Filing Date
EP21790386.3A Pending EP4221776A1 (fr) 2020-10-01 2021-09-30 Dispositif destiné à la production d'un concentré de dialyse

Country Status (5)

Country Link
US (1) US20230405195A1 (fr)
EP (1) EP4221776A1 (fr)
CN (1) CN116322818A (fr)
DE (1) DE102020125648A1 (fr)
WO (1) WO2022069612A1 (fr)

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5591344A (en) * 1995-02-13 1997-01-07 Aksys, Ltd. Hot water disinfection of dialysis machines, including the extracorporeal circuit thereof
DE10034368C1 (de) 2000-06-17 2001-08-30 Fresenius Medical Care De Gmbh Dialysevorrichtung und Verfahren zum Betreiben einer Dialysevorrichtung
CN105233358B (zh) * 2015-10-28 2017-10-17 成都圣仁康医学研究院（有限合伙） 一种透析液配液机及其控制方法
DE102016101648A1 (de) 2016-01-29 2017-08-03 Fresenius Medical Care Deutschland Gmbh Verfahren zum Regeln einer Heizvorrichtung zum Erwärmen eines Fluids für einen Dialysierflüssigkeitskreislauf, Steuervorrichtung sowie Blutbehandlungsvorrichtung
DE202016002935U1 (de) 2016-05-09 2016-05-27 Fresenius Medical Care Deutschland Gmbh Fluidsystem für eine medizinische Behandlungsvorrichtung, insbesondere eine Vorrichtung zur extrakorporalen Blutbehandlung, und Vorrichtung zur extrakoroporalen Blutbehandlung mit einem derartigen Fluidsystem
DE102017001770B4 (de) 2017-02-23 2023-06-22 Fresenius Medical Care Deutschland Gmbh Extrakorporale Blutbehandlungsvorrichtung zum Betreiben einer extrakorporalen Blutbehandlungsvorrichtung
US11207454B2 (en) * 2018-02-28 2021-12-28 Nxstage Medical, Inc. Fluid preparation and treatment devices methods and systems

Also Published As

Publication number Publication date
US20230405195A1 (en) 2023-12-21
DE102020125648A1 (de) 2022-04-07
WO2022069612A1 (fr) 2022-04-07
CN116322818A (zh) 2023-06-23

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