EP3755395A1 - Mélange d'un liquide de dialyse basé sur un modèle pour un appareil de dialyse - Google Patents

Mélange d'un liquide de dialyse basé sur un modèle pour un appareil de dialyse

Info

Publication number
EP3755395A1
EP3755395A1 EP19706535.2A EP19706535A EP3755395A1 EP 3755395 A1 EP3755395 A1 EP 3755395A1 EP 19706535 A EP19706535 A EP 19706535A EP 3755395 A1 EP3755395 A1 EP 3755395A1
Authority
EP
European Patent Office
Prior art keywords
dialysis fluid
component
dialysis
substance
conductivity
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
EP19706535.2A
Other languages
German (de)
English (en)
Inventor
Pia Daniel
Alfred Gagel
Carsten Mueller
Christoph Wiktor
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.)
Fresenius Medical Care Deutschland GmbH
Original Assignee
Fresenius Medical Care Deutschland 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 Fresenius Medical Care Deutschland GmbH filed Critical Fresenius Medical Care Deutschland GmbH
Publication of EP3755395A1 publication Critical patent/EP3755395A1/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
    • 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
    • A61M2205/18—General characteristics of the apparatus with alarm
    • 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
    • A61M2205/60—General characteristics of the apparatus with identification means
    • 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
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/65—Impedance, e.g. conductivity, capacity

Definitions

  • the present invention relates to a monitored and model-based mixture of a dialysis fluid for a dialysis machine. It relates in particular to a mixing device, to a dialysis machine with such a mixing device and to a method for operating the mixing device.
  • Dialysis machines are blood treatment devices in which a patient's fluid is delivered via a fluid line to a fluid treatment component, treated by the fluid treatment component, and returned to the patient via the fluid line that can be divided into an arterial and a venous branch.
  • Examples of such blood treatment devices are in particular flämodialyse Erasmus.
  • Such a blood treatment device is the subject of DE 198 49 787 C1 of the Applicant, the content of which is hereby incorporated in full in the disclosure of the present application.
  • Dialysis is a procedure for purifying the blood of patients with acute or chronic renal insufficiency. Basically, a distinction is made here between methods with an extracorporeal blood circulation, such as flämodialysis, flämofiltration or flämodiafiltration and peritoneal dialysis, which has no extracorporeal blood circulation.
  • the blood is passed in the flaemodialysis in an extracorporeal blood circulation through the blood chamber of a dialyzer, which is separated by a semipermeable membrane of a dialysis fluid chamber.
  • the dialysis fluid chamber is traversed by a blood electrolyte contained in a certain concentration dialysis fluid.
  • the substance concentration of the blood electrolytes in the dialysis fluid corresponds to the concentration of blood electrolytes in the blood of a healthy person.
  • the patient's blood and the dialysis fluid on both sides of the semipermeable membrane are generally passed countercurrently at a predetermined flow rate.
  • Urinary substances diffuse through the membrane from the blood chamber into the dialysis fluid chamber, while electrolytes present in the blood and dialysis fluid diffuse from the higher concentration chamber to the lower concentration chamber, respectively. If a pressure gradient from the blood side to the dialysate side is established on the dialysis membrane, for example by a pump which withdraws dialysate from the dialysate circuit downstream of the dialysis filter on the dialysate side, water comes out of the dialysate
  • ultrafiltrate is withdrawn from the patient's blood by applying a transmembrane pressure in the dialyzer without dialysis fluid being passed on the side of the membrane of the dialyzer opposite the patient's blood.
  • a sterile and pyrogen-free substituate solution can be added to the patient's blood.
  • this Substituatains is added upstream of the dialyzer or downstream, it is called pre- or post-dilution. The mass transfer takes place at the
  • Hemodiafiltration combines the methods of hemodialysis and hemofiltration. There is both a diffusive mass transfer between the patient's blood and dialysis fluid via the semipermeable membrane of a dialyzer instead, as well as a filtration of plasma water contained in the blood by a
  • Plasmapheresis is a blood treatment procedure in which the patient's blood is separated into the blood plasma and its corpuscular components (cells). The separated blood plasma is purified or replaced with a substitution solution, and the purified blood plasma or the substitution solution is returned to the patient.
  • peritoneal dialysis the abdominal cavity of a patient is filled via a guided through the abdominal wall catheter with a dialysis fluid having a concentration gradient of blood substances such as electrolytes (for example, sodium, calcium and magnesium) against the body's own fluids.
  • blood substances such as electrolytes (for example, sodium, calcium and magnesium) against the body's own fluids.
  • electrolytes for example, sodium, calcium and magnesium
  • peritoneum peritoneum
  • the method for peritoneal dialysis is usually carried out with the aid of automatic peritoneal dialysis machines, such as those sold by the Applicant.
  • RO reverse osmosis
  • a water tank for the RO water and containers for different concentrates or components for producing the dialysis fluid can be used.
  • the concentrates can be provided in solid and / or liquid form.
  • dialysis fluid acidic concentrate A component
  • B component a basic one Concentrate
  • the basic concentrate usually consists of a sodium bicarbonate solution of defined concentration.
  • the acidic concentrate contains all the other ingredients necessary for the dialysis treatment. These are mainly the electrolytes sodium, potassium, calcium, magnesium and moreover the components chloride, acetate.
  • the acidic concentrate may also include glucose.
  • the mixture is carried out by means of a volumetric mixing method in which water and concentrate are mixed with one another in a certain predetermined volumetric ratio.
  • a second method for the production of dialysis fluid is the conductivity-controlled method, in which the ratio of the water and concentrate components is controlled so that in the final dialysis a certain conductivity is established, resulting from the electrolyte or substance concentrations in the final dialysis.
  • This second conductivity controlled method aims to improve the present invention.
  • the composition of the dialysis fluid is monitored.
  • the standard ISO EN DIN 60601-2-16 requires dialysis machines to monitor the composition of the sodium and bicarbonate dialysis fluid.
  • the protection system must be defined
  • the conductivity of the ready-mixed dialysis fluid is used as the measured variable.
  • the expected value of the conductivity with the specified setpoint values is calculated on the basis of the electrolyte
  • the electrolyte concentrations must be known to the device.
  • the concentrations of the individual electrolytes Na, K, Ca, Mg, Cl, acetate, citrate, bicarbonate
  • other components eg, possibly glucose
  • the present invention has therefore set itself the task to automate the mixing of the dialysis fluid and to improve while maintaining the flexible ability to change the sodium and bicarbonate values.
  • the composition of the Dialysis fluid to be subjected to an automatic review.
  • the mixture and consequently the overall treatment should be made safer.
  • a numerical calculation model based on a simplified calculation should be the basis.
  • the data thus calculated are provided as a result data set, which comprises quasi a formulation with an expected value for the conductivity of the resulting dialysis fluid.
  • a second approach (operating procedure) to check whether the previously determined recipe is complied with.
  • the mixing result should be monitored for compliance with the specifications of the previously determined recipe.
  • sensors for measuring the conductivity provided that compare the measured conductivity with the calculated expected value from the result data set.
  • the second method is performed after the first method. Both methods solve the same problem, but in principle can be used independently.
  • the invention relates to a method for calculating a result data set for the composition of a dialysis fluid to be mixed (at least two) to be mixed (for use in a dialysis machine) on the basis of a calculation model for the conductivity of the dialysis fluid, comprising the following method steps:
  • a component eg A concentrate, acidic
  • B component eg B concentrate, basic, only salts
  • RO water another (or second or third) component
  • it can also be user-determined and via a
  • User interface can be entered by the user. It is also possible to add further constituents or components of the dialysis fluid.
  • component parameters comprising a first substance concentration parameter representing the concentration of a substance in the A component and a second substance concentration parameter representing the concentration of the substance in the B component.
  • the component parameters refer to concentrations in the individual components or concentrates in a not yet mixed state. In particular, they do not relate to concentrations in the dialysis fluid to be mixed (mixed state).
  • the component parameters refer to chemical Details of the components in not yet mixed state (raw state, eg as concentrate).
  • composition in particular resulting from the read-in mixing ratio data set and the detected component parameters of the (to be produced) dialysis fluid, comprising an indication of substance concentrations (in particular electrolyte concentrations) in the (to be produced) dialysis fluid and an expected value for the Conductivity of the (to be produced) dialysis fluid based on the calculation model.
  • the result data set refers to the mixed state of the dialysis fluid.
  • the method comprises:
  • Result data set each lie in a predefined normal range and, if so, save the mixing ratio record as confirmed
  • This embodiment has the advantage that only confirmed formulations can be stored in the system, ie those which fulfill predefinable standard range specifications.
  • the A-concentrate contains salts and the acid.
  • the B concentrate contains only salts, d. H. no acid.
  • the first and second substance concentration parameters relate to the concentration of a particular substance (in particular salt) in the different components in the
  • an acid concentration can also be detected for selected components.
  • the read-in mixture ratio record acts as a (confirmed) recipe in the case of a successful check, wherein the recipe is uniquely assigned an ID number or an identification code. This can be used very efficiently
  • the method additionally comprises (after calculating the result data set) the following method step (e):
  • Dialysis fluid used by the current conductivity of the prepared dialysis fluid is measured and compared with target specifications (in particular from a recipe) and / or with the calculated expectation value for the conductivity to an error message in case of mismatch
  • the substance concentrations are, in particular, salt concentrations. In another advantageous embodiment of the invention, this is based
  • the calculation model serves to predict the conductivity of the resulting dialysis fluid as a solution containing several different ones
  • the calculated result data set can be used for dialysis
  • Electrolytes can be read from pre-stored tables for different concentrations.
  • V a Dosing volume of A concentrate in the respective A pump [mL] Vmix total dialysis fluid volume per batch or mixing cycle
  • the mix ratio record is entered with the sum of all
  • Dialysis fluid salts are computer-based and automatically calculated.
  • the dialyzing fluid mixture ratio with respect to the solution of the A concentrate can be expressed mathematically as follows:
  • Component or can be derived in the concentrate A can be calculated by
  • V a Volume of concentrate A in which the masses mx are dissolved [L]; Mx is the molar mass of the substance X [g / mmol];
  • the calculation model for calculating the expected value for the conductivity of the dialysis fluid to be generated is based on the finding that the chemical bonds between the electrolytes, partially or completely interrupted when the substances are dissolved in water. They then dissociate into positively and negatively charged ions.
  • the mobile charge carriers carry the electricity in the aqueous solution.
  • Increasing electrolyte concentrations C usually increase the conductivity K, which is defined as:
  • K l / A cell constant of the LF sensor [1 / m].
  • the slope of the conductivity decreases with increasing concentration C, due to the weakened mobility of the ions. This can be experimentally measured in the molar conductivity
  • the calculation model is based on the simplification that the molar conductivity of the individual electrolytes / salts is regarded as only dependent on the total electrolyte concentration Q, and from this an expected value for the conductivity of the dialysis fluid is determined. The consideration of the interdependencies between the individual components is not necessary and is therefore not calculated in the calculation model.
  • the salt strength Q can thus be calculated in the calculation model as the sum of the molar concentrations of all salts.
  • the unit is mol / liter.
  • the salt strength Q can be represented in the following formula for an exemplary dialysis fluid.
  • C indicates the molar concentrations of the respective salts NaCl, NaBic, KCl, CaCl, MgCl, NasCit, NaAc.
  • KNaCI ANSCI * CNSCI [uS / cm]
  • Kka Lka * CKCI [uS / cm]
  • the expected value CDü.exp for the conductivity in the result data set is calculated as the sum of all conductivity distributions, with:
  • the component parameters comprise a glucose concentration. This may represent the molar concentration of glucose in the A component.
  • the method or method of operation for a mixing device additionally comprises (after calculating the result data set) the following method step:
  • the calculated result data set can be subjected to an automatic check.
  • the calculated result data set may be e.g. be checked for compliance with normal standards. Furthermore, a plausibility check of the calculated result data set.
  • the invention relates to a computing unit for calculating a result data set for establishing a dialysis fluid from a plurality of components on the basis of a calculation model for the conductivity of the dialysis fluid, comprising:
  • Dataset is determined, which represents a mixing ratio of at least one A-component (A-concentrate) and - optionally a B-component (B-concentrate) and - another (or possibly third) component (RO-water);
  • Parameter is determined, comprising a first substance concentration parameter, the concentration of a substance and in particular the concentration of salt in the A component
  • a second substance concentration parameter representing the Concentration of the substance and in particular represents the concentration of salt in the B component
  • a processor used to calculate the result data set for
  • Composition of the dialysis fluid comprising an indication of the substance resulting in the mixture to be generated.
  • the arithmetic unit may include an output unit (e.g., graphic Ul).
  • the arithmetic unit may additionally include:
  • a user interface via which an actuation signal can be received via which an actuation signal can be received;
  • Computing unit additionally include:
  • a sensor interface for receiving sensor signals for the measured conductivity of the dialysis fluid
  • the arithmetic unit is designed to measure the measured conductivity of the dialysis fluid with DESIRED specifications, e.g. from the recipe and / or with the calculated expectation value for the conductivity to match in order to output an error message if there is no match. If they match, a validation signal may be output that initiates the delivery of dialysis fluid to the dialysis machine.
  • the invention relates to a mixing device for producing a dialysis fluid from a plurality of components with:
  • An A connection to a first container to provide an A component optionally: a B-connection to a second container to provide a B-component;
  • the mixing device can be operated in different operating modes.
  • a 1 MIX process can be used in which only the acid and salt containing A component is mixed with RO water.
  • a 2MIX method can be used in which, in addition to the A component, the
  • the invention relates to an operating method for such a mixing device, in which the mixing means for mixing the dialysis fluid are controlled with control commands, wherein the control commands from the
  • Result data set to be calculated In the operating method, it is preferably automatically checked whether the components (or constituents) indicated in the formulation each have the
  • corresponding storage containers e.g., in the form of canisters
  • corresponding storage containers for mixing have been connected to the mixing device or to the dialysis machine by comparing a component-identifying code at the respective storage container with a respective stored reference to agreement. This can advantageously be excluded errors that are based on a wrong choice of the concentrate bag.
  • the invention relates to a dialysis machine with such a computing unit and / or with such a mixing device.
  • the arithmetic unit is an electronic component. It can be designed in hardware and / or software and serves to calculate a result data set for the composition of the dialysis fluid with an expected value for the conductivity.
  • a dialysis machine for example a hemodialysis machine or a peritoneal dialysis machine.
  • the invention can be equally applied or applied to other medical, computer controlled, or fluid management or blood treatment equipment that mixes concentrates in a particular mixing ratio
  • Dialysis fluid must be supplied.
  • the dialysis fluid is a dialysis solution that typically contains solutes, such as:
  • Buffers for example bicarbonate, acetate, lactate .
  • glucose or other osmotic agents, as an osmotic agent in peritoneal dialysis or to maintain blood sugar levels during hemodialysis;
  • Acids or salts of acids for example, HCl or CI, acetic acid
  • Citric acid which may contribute to the neutralization of basic dialysis dialysis solutions or present as counter-ions in the electrochemical equilibrium.
  • the recipe is a confirmed result record. As a recipe, therefore, only those component mixtures for the dialysis fluid are stored in the system or memory, the predefined target specification, e.g. Observe the limits and limits required for dialysis.
  • Another task solution is a computer program product that is loaded or loadable into a memory of a computer or a dialysis machine with a computer program for carrying out the method described in more detail above, when the computer program is executed on the computer or the dialysis machine.
  • a further task solution provides a computer program for carrying out all method steps of the method described in more detail above, when the computer program is executed on a computer, an electronic or medical device. It is also possible that the computer program is stored on a readable for the computer or the electronic or medical device medium.
  • Fig. 1 shows a schematic representation of a dialysis machine with a
  • Fig. 2 is an alternative embodiment of a dialysis machine with integrated
  • Containers and integrated mixing device with an integrated computing unit Containers and integrated mixing device with an integrated computing unit.
  • FIG. 3 shows a schematic representation of a computing unit and the read and output signals or data sets according to a further exemplary embodiment of the invention.
  • Verification procedure for testing mixed dialysis fluid based on sensor-measured conductivity and related controls.
  • Fig. 1 shows schematically a dialysis machine or a dialysis machine DG with other modules.
  • the dialysis machine DG For dialysis treatment, the dialysis machine DG must be supplied with a dialysis fluid df.
  • the dialysis fluid df is mixed from several concentrates or components according to a predetermined or user-defined formulation. The components are usually provided in separate containers 1A, 1B, 1C.
  • the dialysis fluid df necessary for the extracorporeal blood treatment can - as shown in FIG. 1 - be mixed by a separate mixing device M.
  • Fierstellen the dialysis fluid df can be prepared by mixing (wet / dry) concentrates (acidic A component, basic B component) with RO water, the i.d.R. is provided by a central RO water treatment within the dialysis station, take place after a certain prescribed mixing ratio.
  • the dialysis fluid df is an aqueous solution of electrolytes, buffers and possibly glucose.
  • the kidney of patients on dialysis is no longer able to excrete acid via the urine, which increases the risk of latent acidosis.
  • the dialysis fluid should assume a physiological PH value that corresponds to that of a healthy person.
  • acidic and basic components (A and B component or concentrate) are mixed together with RO water.
  • the basic component often used is sodium bicarbonate powder (NaHCO 3) dissolved in RO water.
  • the mixture with RO water produces sodium and bicarbonate in the finished dialysis fluid.
  • Bicarbonate acts as a pH buffer in the patient's blood.
  • bicarbonate diffuses across the membrane of the dialysis filter into the patient's blood and "buffers" the desired pH in the blood, ie keeps it stable at a level.
  • the present invention is based on the monitoring of the dialysis fluid composition, in particular on the monitoring of the conductivity by comparison with an expected value.
  • the values for the volume fractions of concentrates A (11) and B (eg 1,831) and RO water (eg 341) given on the concentrate containers were entered into the dialysis machine.
  • the substance concentrations given on the concentrate containers 1 A, 1 B in this case relate to the stated mixing ratio of the components A, B and RO water. As a rule, this mixing ratio is not changed. However, there is the possibility of changing the values for the sodium concentration and for the bicarbonate concentration, for example in order to achieve a specific therapeutic goal (adjustment of the sodium content in the patient's blood).
  • a change of said values automatically results in a change of the aforementioned mixing ratio.
  • the electrolyte concentrations indicated on the concentrate containers 1A, 1B therefore no longer correspond to reality in this case.
  • the previous method is thus error-prone, especially if the substance concentrations are changed by the user.
  • This has the technical background that the sodium and the acid concentration of a mutual dependence are subject, because their concentration changes by chemical reaction with each other in the other concentrate containers substances.
  • the present invention proposes to solve the above-described problem in previous systems that, instead of the electrolyte concentrations, the concentrations of the salts (NaCl, Kcl etc.) and the acids (acetic acid, citric acid) of the concentrates (in unmixed state) are entered into the dialysis machine ,
  • these values must always be completely determined by the manufacturers of the concentrate Containers 1A, 1B are provided.
  • the values can either be entered manually or automatically by the user (eg via correspondingly applied identification codes which are read in and automatically assigned to the respective ingredient by means of an electronically stored table). From these data, according to the invention, the electrolyte or substance concentrations in the ready-mixed dialysis fluid df and the resulting expectation value for the conductivity of the finished dialysis fluid df are calculated using a mathematical-chemical calculation model.
  • the mixing device M can be controlled by control commands sb, which receives them from a - in this embodiment, separate - arithmetic unit R.
  • the control commands control mixing means of the mixing device and are calculated based on the result data set.
  • the mixing device is used for mixing and preparation of the dialysis fluid df, which is transmitted to the dialysis machine DG.
  • the different containers for the components for mixing the dialysis fluid df can be provided with identification codes.
  • the A-component contained in the A-container 1A is identified with the identification code 1 Ai.
  • the respective identification code thus indicates in a mathematically unambiguous manner the container and indirectly the ingredient and / or the substance concentration contained therein (in particular salt concentration).
  • the B container 1 B with the B component or with the B concentrate is eg provided with the identification code 1 Bi.
  • the identification code may be a digital code (bar code, QR code) or any other identifying tag (NFC tag) deposited on the container.
  • the assignment between code and container is stored in the arithmetic unit R. In this way, a check can be made on the arithmetic unit R as to whether the corresponding, correct containers are also connected or used for mixing for the respectively prescribed formulation for the dialysis fluid df. This check will be explained in more detail below in connection with FIG.
  • the architecture of the system with separate modules M, R, DG, shown by way of example in FIG. 1, can alternatively also be varied. Fig.
  • the dialysis machine DG comprises the above-mentioned modules of the mixing device M with the integrated computing unit R. Also included are the chambers or containers 1A, 1B, 1C, 1D for the individual concentrates for mixing the dialysis fluid df. In this example, 4 components are used. The number of components is variable. Usually, 3 components (2 concentrates with RO water) are mixed. For a person skilled in the art, it is in the Flanders that other variations of the architecture are within the scope of this invention. Thus, for example, certain modules can be connected as separate modules via a corresponding connection, such as the containers, for example, can be provided as mobile units and connected to the dialysis machine DG via corresponding hose connections.
  • the arithmetic unit R comprises a processor P as
  • the processor P is in data exchange with a memory MEM, in which the calculation model BM is stored and with a further memory, which may be formed as a database DB.
  • a large number of confirmed recipes are stored in the database DB.
  • the database DB and / or the memory MEM can in alternative
  • Embodiment also be outsourced so that the arithmetic unit can be made slimmer (smaller).
  • the arithmetic unit R further comprises different interfaces: An input interface 31 for reading in the mixture ratio data set 311, a component interface 32 for detecting component parameters, in particular for detecting a first one
  • Concentration parameter 322-2 Both concentration parameters relate to the concentrates from the containers 1A, 1B (and possibly other containers or components).
  • the concentration parameters 322-1, 322-2 preferably comprise a salt concentration in the respective component. In particular, they do not relate to the dialysis fluid df to be admixed, as was provided in the prior art.
  • the information necessary for the concentrate parameters can all be taken from the information on the containers or they can - as explained above - also be recorded automatically.
  • the acquired and read data are transmitted to the processor P.
  • the processor P is used to calculate a result data set 331.
  • the result data set 331 can first on a user interface Ul for
  • the result data set 331 is used to specify the composition of the dialysis fluid df to be mixed.
  • the result data set 331 comprises an indication of substance concentrations, in particular to electrolyte and salt concentrations of the dialysis fluid df to be admixed and an expected value for the conductivity of the liquid df to be admixed.
  • the calculation of the processor P is based on the calculation model BM.
  • the result data set 331 is output on the user interface U1, which can be designed as a graphical user interface. This allows the user to confirm the result data set 331 with an acknowledgment signal 34.
  • the result data set 331 is then transmitted to the mixing device M for mixing the dialysis fluid df.
  • the result data set is here enriched with control commands sb, which allow the mixing device to be controlled in such a way that the stored recipe is obtained, which is then provided to the dialysis machine DG.
  • the invention proposes a specific menu guide that instructs the user to make the necessary and necessary for the calculation step by step inputs. Through appropriate masks on a screen surface, it is passed through an input menu. This reduces the risk of errors. After entering the data required for the calculation, it is automatically executed to provide the result data set 331 (particularly on the user interface).
  • the arithmetic unit R comprises, in addition to the aforementioned interfaces, a further interface 34 for detecting sensor signals for the measured conductivity 41 of the dialysis fluid produced by the mixing device.
  • the arithmetic unit R receives the signals from at least one (preferably several) conductivity sensor (s) S via the interface 34 and forwards the conductivity signals 41 to the processor P for checking to ensure that the conductivity is within the intended range was defined by the recipe and / or in the result data set 331.
  • the ongoing operation of a mixing device M can be monitored, which increases the overall safety of the dialysis machine DG.
  • the arithmetic unit R for checking a ready-mixed dialysis fluid df for compliance with the specifications of the formulation and, in particular, for checking the substance composition.
  • the sensors S for measuring the conductivity of the dialysis fluid df are preferably provided at different positions.
  • a plurality of sensors S for redundant detection of the conductivity at different positions eg at the mixing device M, in the connection between mixing device M and dialysis machine DG and / or on the dialysis machine DG itself
  • the sensors S send their measurement result with the currently measured conductivity 41 as a signal to the computing unit R for checking. This receives the conductivity values via the interface 34 (not shown in Fig. 4).
  • target specifications and / or the recipe with the result data set 331 are stored. If there is a match, the mixed Dialysis fluid df as planned, transmitted to the dialysis machine DG without further message. If the currently measured conductivity 41 does not correspond to the specifications or the expected value, an error message 43 is output.
  • the error message 43 can be output on the mixing device (represented in FIG. 4 by the arrow to the mixing device M) and / or on the dialysis machine DG and / or on a central control and monitoring unit in order to initiate corrective measures. The latter is represented in FIG. 4 by the downwardly pointing arrow with the error message 43.
  • control unit sb is provided by the arithmetic unit R in order to operate and control the mixing device in accordance with the specifications of the result data set 331.
  • the arithmetic unit R additionally assumes the task of controlling and regulating the mixing device M.
  • Fig. 5 is a flow chart of an input method for concentrate parameters.
  • the information about the intended mixing ratio is read in step 51.
  • the mixture ratio data set is read in. This can be done by means of a user input on a user interface (eg the surface of the computing unit R).
  • the information is user-defined.
  • the above-mentioned data it is also possible for the above-mentioned data to be predefined and read in from the memory via the interface 31.
  • the component parameters are detected, that is, the first salt concentration parameter 322-1 and the second salt concentration parameter 322-2.
  • the first and second substance concentration parameters are referred to as salt concentration parameters.
  • the information can either be acquired via the user interface U1 in a first embodiment of the invention.
  • the identification code 1 Ai, 1 Bi next to Identification notice still another data field, in which the respective salt concentration parameter 322-1 and 322-2 of the respective components is represented.
  • the further data field can also be provided separately, for example as a QR code on the container of the manufacturer of the concentrate.
  • an assignment table be deposited, in which the component parameters are stored for the respective identification code of the concentrate or the component. Through an access (eg look-up table) to this table, the component parameters can thus also be detected automatically in this third variant of step 52.
  • the resulting dialysis fluid parameters are calculated.
  • a tabular listing can be displayed in a separate screen mask, which contains the resulting electrolytes and the conductivity to the respective concentrate (with a uniquely assigned ID number). This list may be subject to a review, in particular an audit for compliance with predefined admissibility values or ranges.
  • step 53 the result data set 331 is calculated by accessing the calculation model BM.
  • step 54 it is checked whether the resulting concentrations are within the predefinable standard range for dialysis. If no, a warning message is issued in step 56. If necessary, a hint can be issued on the surface U1 informing the user about the wrong formulation and giving further indications as to which values were decisive for the exceeding of the limit value. If the test in step 54 is successful, the recipe can be confirmed in step 56. Only confirmed recipes can subsequently be stored in the memory DB in step 57. The process then ends or is executed repeatedly.
  • An operating method for a mixing device that can be integrated in a dialysis machine DG or connected as a separate device of the dialysis machine DG, for example, could have the following sequence:
  • a new formulation proposal for a dialysis fluid is entered, in which the mixing ratio (mixing ratio data set : A, B concentrate, RO water) is selected and the salt and, if necessary, the glucose concentration and glucose concentration (glucose is an optional ingredient) is entered as a component parameter in the menu.
  • This recipe proposal can already be assigned an ID number for the purpose of identification.
  • the formulation proposal is hereafter examined by using the stored calculation model, the resulting substance concentrations of the prepared according to the recipe proposal dialysis fluid are determined and displayed in a screen.
  • the arithmetic unit R or the dialysis machine DG with the arithmetic unit R is configured in such a way that the internally or externally determined recipe and in particular the calculated result data set is used to appropriately prepare and monitor the dialysis fluid by suitable means.
  • the dialysis machine has devices or connections for connecting the concentrate container and the RO water, and means for conveying and mixing of the components according to the selected recipe (dosing pumps, mixing chambers, etc., not shown in the figures), and conductivity sensors S preferably in a fresh dialysate liquid line for monitoring the conductivity with respect to the expected value of the conductivity calculated in the result data set.
  • the temperature of the dialysis fluid can be regulated to a physiologically sensible value and the conductivity measurement is temperature-compensated.
  • the solution proposed here has the technically advantageous effect that the concentrate parameters 322-1, 322-2 are detected redundantly. This has the advantage that errors can be detected by information on the
  • Concentrate containers 1A, 1B result, which refer to other mixing ratios (different from the recipe). Errors may arise, for example, in that two different details are printed on the concentrate bag that contradict each other.
  • the electrolyte concentrations given in the first field result in a dilution of the A concentrate by a factor of 1:34.
  • the A concentrate is diluted by a factor of 1: 36.83 in dialysis fluid preparation (as indicated in the second panel).
  • Treatmenthafate can thus be detected automatically if the specified electrolyte concentrations refer to a different dilution or mixing ratio than the recipe corresponds.
  • incorrectly printed values can also be recognized in the lists of ingredients on the concentrate bags 1A, 1B. If e.g. the acetate concentration is given in a first list on the pouch 1A at 3.0mmol / L and in a second list of another pouch 1A '0.3mmol / L, although in both A concentrates the same amount of acetic acid (H - Acetate) is weighed, this source of error can be detected automatically.
  • an important advantageous effect of the approach presented here is that the calculation model for determining the conductivity of the dialysis fluid mixed from concentrates with a plurality of electrolytic constituents and RO water for determining the molar conductivity takes into account only the total concentration of all electrolytic constituents; this is also referred to as salt strength Q. Dependencies between the individual electrolytic components are not considered. Tests have shown that this simplification allows the conductivity of the resulting dialysis fluid to be modeled with sufficient accuracy and thus a qualitatively good result can be provided.
  • MEM memory for storing the calculation model and / or data

Abstract

La présente invention concerne un procédé et une unité de calcul (R) pour le calcul d'un jeu de données de résultat (331) destiné à la composition d'un liquide de dialyse (df) à mélanger à partir de plusieurs composants sur la base d'un modèle de calcul (BM) pour la conductivité du liquide de dialyse, ainsi qu'un dispositif de mélange (M). Ledit procédé comprend les étapes suivantes : - lecture (51) d'un jeu de données de rapport de mélange (311) qui représente un rapport de mélange d'au moins un composant A et un composant B et d'un troisième composant; - acquisition (52) des paramètres de composants, comprenant un premier paramètre de concentration en substance qui représente en particulier la concentration en sel dans le composant A et un deuxième paramètre de concentration en substance qui représente en particulier la concentration en sel dans le composant B; - calcul (53) du jeu de données de résultat (331) destiné à la composition résultante du liquide de dialyse, comprenant une indication de concentrations en substance dans le liquide de dialyse et une valeur escomptée pour la conductivité du liquide de dialyse sur la base du modèle de calcul (BM).
EP19706535.2A 2018-02-21 2019-02-18 Mélange d'un liquide de dialyse basé sur un modèle pour un appareil de dialyse Pending EP3755395A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102018103845.3A DE102018103845A1 (de) 2018-02-21 2018-02-21 Modellierbasierte Mischung einer Dialysierflüssigkeit für ein Dialysegerät
PCT/EP2019/053951 WO2019162227A1 (fr) 2018-02-21 2019-02-18 Mélange d'un liquide de dialyse basé sur un modèle pour un appareil de dialyse

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EP3755395A1 true EP3755395A1 (fr) 2020-12-30

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EP19706535.2A Pending EP3755395A1 (fr) 2018-02-21 2019-02-18 Mélange d'un liquide de dialyse basé sur un modèle pour un appareil de dialyse

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EP (1) EP3755395A1 (fr)
CN (1) CN111757763A (fr)
DE (1) DE102018103845A1 (fr)
WO (1) WO2019162227A1 (fr)

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3223051C2 (de) * 1982-06-21 1984-09-13 Fresenius AG, 6380 Bad Homburg Dialysevorrichtung mit geregelter Dialysierlösung
US6139754A (en) * 1991-11-15 2000-10-31 Baxter International Inc. Hemodialysis conductivity servo-proportioning system and method
DE19849787C1 (de) 1998-10-28 2000-02-24 Fresenius Medical Care De Gmbh Blutbehandlungsgerät
WO2006125198A2 (fr) * 2005-05-17 2006-11-23 Fresenius Medical Care Holdings, Inc. Procedes et appareil d'hemodialyse
US10434236B2 (en) * 2015-05-25 2019-10-08 Gambro Lundia Ab Extracorporeal blood treatment apparatus having dialysis fluid parameter data entry

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CN111757763A (zh) 2020-10-09
WO2019162227A1 (fr) 2019-08-29

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