DE102023004226A1 - Computer system for assisting a user in the preparation and execution of a blood treatment session - Google Patents

Abstract

The present invention relates to a computer system (1) for assisting a user in preparing or conducting a blood treatment session for a patient using a blood treatment device (100). The computer system (1) comprises a computing device (5), an input interface (501), and an output interface (503). The input interface (501) is configured for the user to enter input values, which include setting values that are or have been suggested by the user for setting machine parameters of a blood treatment device (100) for extracorporeal blood treatment of the patient during the treatment session. Furthermore, the computing device (5) is programmed to predict, based on the input of the input values, at least one value resulting at a point in time during the treatment session, or a curve resulting over a period of time during the treatment session, for at least one blood parameter of the patient or for at least one test parameter. By means of signal transmission, the computing device (5) can transmit the predicted value or the predicted course to the output interface (503) for the user's information and from there, for example, to an output device (505).

Description

The present invention relates to a computer system according to claim 1, a blood treatment device according to claim 13 and a computer-implemented method according to claim 17 or in each case according to the preambles or generic terms of these claims.

Patients indicated for continuous extracorporeal renal replacement therapy suffer from severe, even fatal, electrolyte and acid-base imbalances. These disturbances manifest themselves in the composition of the blood, the concentrations of its components, or other properties, which are referred to herein as "blood parameters."

A correction of the severely pathological blood composition to physiological blood composition by means of the blood treatment device that is too rapid or too slow must be avoided because of the complications associated with certain blood parameters with irreversible long-term damage to the patient, for example through the formation of edema in sensitive areas, such as the central nervous system, or through central pontine myelinolysis.

For the purpose of blood treatment, setting values for variable treatment parameters must be entered by a user, e.g., clinical staff, on the blood treatment device used for this purpose. The user can initiate changes to such setting values by manual input, for example, via input interfaces, e.g., on a screen (touchscreen) or other interfaces suitable for input.

To achieve predetermined treatment goals or targets, such as the renal dose in dialysis treatment, the user may be required to determine or change a series of settings, some of which interact with each other, which is why setting the blood treatment device can be a demanding and error-prone activity.

This is further complicated by the fact that patient characteristics, such as distribution volumes or the activity of metabolic processes, are also relevant for achieving the aforementioned treatment goals and specifications and can change over time. Furthermore, functional parameters of components of the blood treatment device can change during treatment, which in turn influences the achievement of the aforementioned treatment goals and specifications.

An object of the present invention may be to propose a computer system for assisting a user in the preparation, implementation or simulation of an extracorporeal blood treatment session of a patient carried out by means of a blood treatment device, as well as a blood treatment device for the extracorporeal blood treatment of a patient, which has a computer system according to the invention or is prepared for signal connection to such a system and a computer-implemented method therefor.

The object of the invention can be achieved by a computer system having the features of claim 1. It can further be achieved by a blood treatment device having the features of claim 13 and by means of a computer-implemented method having the features of claim 17.

According to the invention, a computer system is proposed for assisting a user in the preparation or implementation or simulation of an extracorporeal blood treatment session of a patient, in particular in the future, by means of a blood treatment device.

The computer system may be separate from the blood treatment device, it may be connected to the blood treatment device, it may or may not be in signal communication with it.

The computer system comprises a computing device, an input interface and an output interface.

The input interface is configured to input (actively by the user) or read input values, for example suggested by the user or specified via or by a blood treatment device, e.g. via its control device, and/or another device of the computer system, for example stored in a suitable storage device provided for this purpose.

The input values include setting values. These are values used to set or specify machine parameters on the blood treatment device when a patient's blood treatment session is to be performed using the blood treatment device.

The computing device comprised by the computer system according to the invention is programmed to carry out a method to predict, based on the input or reading of the input values, at least one value resulting at a point in time during the treatment session, or a course resulting over a period of time during the treatment session, for at least one blood parameter of the patient or for at least one check or test parameter.

Test or assay parameters, as referred to herein, are parameters that may, for example, relate to the concentration reduction of a test substance, particularly an injected one, particularly as described herein. All of the following statements regarding blood parameters may, in certain embodiments, also apply to test or assay parameters; this is also disclosed.

Furthermore, when carrying out the method, the computing device can transmit the predicted value or curve to a unit beyond the computing device by means of signal transmission, for example to an output interface, for example in order to output the predicted value or curve for the user's information or evaluation, for his orientation or for monitoring the patient and/or the blood treatment session, for example by means of an output device.

Alternatively or additionally, the computing device can be programmed to initiate the control or regulation of the blood treatment device, for example, by changing or adjusting machine parameters already set therein, in particular by means of the control device of the blood treatment device. The change can be based on the predicted value or curve or can be derived therefrom.

According to the invention, a blood treatment device for extracorporeal blood treatment of a patient is proposed, which device has a computer system according to the invention, a display and a control device, is in signal connection with these components or is prepared for signal connection with these components.

Whenever reference is made here to a signal or communication connection between two components, this may be understood as a connection that is already in use. It may also be understood as a preparation for such signal communication (wired, wireless, or implemented in another way), for example, by coupling the two components, such as by pairing, etc.

Pairing is a process that occurs in the context of computer networks to establish an initial connection between computer units for the purpose of communication. The most common example is establishing a Bluetooth connection, which connects different devices (e.g., smartphones, headphones) to each other. Pairing is sometimes also referred to as bonding.

According to the invention, a computer-implemented method is proposed for assisting a user in preparing an extracorporeal blood treatment session of a patient using a blood treatment device.

• - Bereitstellen eines erfindungsgemäßen Computersystems;
• - Eingeben von Eingabewerten, vorgeschlagen durch den Nutzer, aus einem Speichersystem für Daten des Patienten einschließlich Behandlungsdaten oder einem Patientendatenmanagementsystem allgemein stammend oder von dort ausgelesen, oder vorgegeben durch z. B. eine Blutbehandlungsvorrichtung, z. B. deren Steuervorrichtung, und/oder eine Einrichtung des Computersystems, welche Einstellwerte umfassen, welche ihrerseits zum Einstellen oder Festlegen von Maschinenparametern an der Blutbehandlungsvorrichtung zum Durchführen der Behandlungssitzung des Patienten vorgesehen und/oder geeignet sind;
• - Prognostizieren (z. B. basierend auf einer Bilanzierung, etwa einer Stoffbilanz und/oder einer Massenbilanz), basierend auf der erfolgten Eingabe der Eingabewerte wenigstens eines sich zu einem Zeitpunkt während der Behandlungssitzung ergebenden Werts, oder über einen Zeitraum während der Behandlungssitzung ergebenden Verlaufs, für wenigstens einen Blutparameter des Patienten oder wenigstens einen Prüfparameter, und
• - Übermitteln des prognostizierten Werts oder Verlaufs mittels Signalübertragung zur Kenntnisnahme durch den Nutzer mittels der Ausgabeschnittstelle an eine Ausgabevorrichtung.

The computer-implemented procedure includes the following steps:

• - Providing a computer system according to the invention;
• - Entering input values, suggested by the user, originating from or read from a storage system for patient data, including treatment data, or a patient data management system in general, or specified by, for example, a blood treatment device, for example its control device, and/or a device of the computer system, which include setting values which in turn are intended and/or suitable for setting or specifying machine parameters on the blood treatment device for carrying out the patient's treatment session;
• - Forecasting (e.g. based on a balance, such as a material balance and/or a mass balance), based on the input values of at least one value resulting during the treatment session, or over a period of time during the treatment session, for at least one blood parameter of the patient or at least one test parameter, and
• - Transmitting the predicted value or trend by means of signal transmission to an output device for the user's information via the output interface.

In some embodiments, the blood treatment device(s) and the computer system are separate from each other. The term "separate from each other" can encompass, for example, a spatial, physical separation and/or a separation such that no signal communication exists between the blood treatment device and the computer system. In other embodiments, the treatment device(s) and the computer system are connected to each other via signal communication.

In all preceding and following statements, the use of the expression “may be” or “may have” etc. is to be understood as synonymous with “is preferably” or “preferably has” etc. and is intended to explain embodiments of the invention.

Embodiments of the invention may comprise one or more of the features mentioned above or below. The features mentioned herein may be the subject of embodiments of the invention in any combination, provided that a person skilled in the art does not recognize a specific combination as technically impossible.

Embodiments according to the invention are further subject matter of the subclaims.

Whenever numerical terms are mentioned herein, the person skilled in the art will understand these as indicating a numerical lower limit.

Unless this leads to a contradiction recognizable to the skilled person, the skilled person will therefore always read "at least one" or "at least one" alongside the term "a" or "an." This understanding is also encompassed by the present invention, as is the interpretation that a numerical word such as "a" can alternatively be meant as "exactly one," wherever this is recognizably technically possible to the skilled person. Both are encompassed by the present invention and apply to all numerical words used herein.

Whenever a suitability or a method step is mentioned herein, the present invention preferably also comprises a corresponding programming or configuration of a suitable device, in particular according to the invention, or a section thereof.

If it is disclosed herein that the subject matter according to the invention has one or more features in a specific embodiment, it is also disclosed herein that the subject matter according to the invention expressly does not have precisely this or these features in other, likewise inventive embodiments, e.g., by way of a disclaimer. Thus, for each embodiment mentioned herein, the opposite embodiment, for example, formulated as a negation, is also disclosed.

Whenever an embodiment is mentioned herein, it is an exemplary embodiment of the invention.

In the event of doubt on the part of the person skilled in the art, the terms “top” and “bottom” are to be understood as absolute or relative spatial specifications which refer to the orientation of the component in question during its normal use.

Whenever an "output device" is mentioned herein, it can be any device known in the art capable of presenting data provided by any device of a computer system, such as an output interface, for use by a user. An output device can be or include a display device (with or without a GUI (Graphical User Interface)), such as a monitor, display or screen, a printer, or the like.

Whenever an “input device” is mentioned herein, it can be any device of the prior art which is capable of inputting data which is entered by a user. to any device within a computer system, for example, to an input interface, for further processing. An input device can be or include a correspondingly configured touchscreen, a rotary switch, a slider, a keyboard, or the like.

The input device and output device can be identical, i.e., implemented as a single, common device. Alternatively, they can be different and/or independent of each other. The input device and output device can be implemented as a touchscreen.

When reference is made herein to a setting value or a preset, this can be a value last set, for example, by the physician or other medical personnel, a suggested value, a displayed value, or a default setting for setting machine parameters of the blood treatment device, particularly for extracorporeal blood treatment of a patient in a treatment session. A value set at the factory or by a service technician is optional but not mandatory.

In some embodiments of the computer system according to the invention, the setting values include pump rates for the pumps of the blood treatment device, ultrafiltration volumes, heating rates, sodium and/or bicarbonate concentrations of the dialysis fluid, treatment modes, and/or the like. In some embodiments, setting values can include all those values that can be set or are usually set by the user on the blood treatment device for treating the patient.

In some embodiments, the input values further comprise measured or otherwise collected values of the patient's blood parameter, collected prior to the start of the procedure and/or treatment session. These may be known from blood samples, the patient's medical record, or patient history.

• - Natriumkonzentration oder Natriumionenkonzentration
• - Kreatin, Harnstoff, Bicarbonat, Kalium, Calcium, Chlorid.

In some embodiments, the blood parameter(s) comprise(s) one or more of the following blood parameters:

• - Sodium concentration or sodium ion concentration
• - Creatine, urea, bicarbonate, potassium, calcium, chloride.

In some embodiments, the input values further comprise measured or otherwise collected values of the patient's blood parameter, collected after the start of the procedure or treatment session. These may be known from blood samples taken after the start of the procedure or blood treatment session. The input values may also be time series of the blood parameters.

In some embodiments, the computer system according to the invention is further programmed to make a statement about the condition of a blood filter used for blood treatment according to predetermined rules based on the predicted value or progression of the blood parameter. The predetermined rules can, for example, be stored in a suitable storage device provided for this purpose.

The rules may, for example, involve comparing a predicted value or trend with an actual, e.g., measured value or trend. If there is no deviation or an acceptable deviation (e.g., measured against a threshold value), it can be assumed that the blood filter is in sufficiently good condition, functioning as expected of a perfectly functioning blood filter. If there is a deviation, it can be assumed that the condition of the blood filter precludes treatment such that the predicted value or trend occurs, for example, because its membrane permeability to certain substances has decreased. Empirical values can be used to estimate the exact condition of the blood filter. These values can be stored in the memory device.

A rare but possible complication during blood treatment sessions is the phenomenon known in practice as "clogging.""Clogging" represents a decreasing exchange capacity across the semi-permeable membrane of the blood filter during the course of the treatment. In such cases, the value or trend of a reference substance predicted by the computer system (e.g., the theoretically expected concentration of the same in the patient's blood) does not correspond to the actually measured value or the value determined by other methods, including approximate methods, or does not correspond to the actual trend of the concentration. or the like of the reference substance in the patient's blood (i.e., the actual concentration), or vice versa. The visualization provided by the computer system allows such "clogging" cases to be detected early, and by changing the dialyzer, an increasing concentration of malignant substances in the patient's blood can be advantageously avoided.

The detection of such “clogging” cases or other conditions of the blood filter is carried out in some embodiments by the user, in some embodiments automatically or semi-automatically by the computer system according to the invention.

In some embodiments, the computer system is further programmed to predict, according to predetermined rules, a state of a blood filter used for blood treatment for at least one point in time in the future based on the predicted value or progression of the blood parameter.

It is therefore possible not only to determine the current condition of the blood filter, for example, at the moment when a current blood analysis is available and thus a real value is available, but also to approximate the condition at a later time. For example, by drawing on experience or empirical values that may be stored in the memory, it may be possible to make a prediction, based on deviations between the predicted value or trend and the real value or trend, when a specific condition of the blood filter will occur or have occurred. The result of this analysis may be that the blood filter will continue to filter sufficiently well for the next hour but should be replaced afterward, or that an extension of the treatment session will be necessary, etc.

In some embodiments, the computer system is further programmed to make a statement about the patient's metabolic activity or other patient characteristics relevant for blood treatment according to predetermined rules based on the predicted value or progression of the blood parameter. For example, citrate can be used for anticoagulation during blood treatment, some of which then enters the patient and is metabolized by them. If this metabolism is inadequate, effects on certain blood parameters result. The computer system according to the invention can then infer a likely altered metabolic activity with regard to citrate from deviations between predicted and subsequently occurring values and at least provide a corresponding indication to the user. Another example is a deviation between the predicted and expected calcium concentration in the blood or the required amounts of calcium to be administered during blood treatment. In such a case, the computer system according to the invention can alert the user to the possibility that relevant amounts of calcium are being mobilized from deep compartments such as the bone.

In some embodiments, the computer system according to the invention can optionally be used for education and training purposes. In this way, life-threatening scenarios for patients can be simulated in a safe digital environment, thus avoiding errors in reality.

In some embodiments, the computer system is further programmed to measure the predicted value or trend against single-sided or multi-sided limit values or boundary ranges or reference values or reference ranges, to compare it with them, and/or to display it in dependence thereon. Trends, indications, and/or alarms can be displayed or output.

In some embodiments, the computer system according to the invention further comprises an output device, in particular as described herein, for example in the form of a monitor.

The output device is prepared or configured to receive and output, in particular to indicate, the predicted value or the predicted course of the at least one blood parameter in signal connection with the output interface, in particular over the time axis.

In some embodiments, the computer system is further prepared, configured, programmed, or the like to suggest at least one change to at least one setting value or input setting value, or a substitute therefor, according to predetermined rules. The suggestion may be based on or take into account the predicted value or progression of the blood parameter and may be performed such that upon setting this suggested setting value, the subsequently re-predicted ized or predictable value or course of at least one blood parameter as described herein lies between limit values or within limit ranges or between reference values or within reference ranges.

In some embodiments, the computer system further comprises a blood treatment device with a control device configured to receive the setting values transmitted via signal transmission. The computer system may be configured to transmit the setting values to be received.

In some embodiments of the computer system, the control device is programmed to control or regulate the blood treatment device based on the setting values transmitted via signal transmission.

Changing at least one setting value or input setting value, or specifying a substitute therefor, can be done, for example, based on known algorithms, derived from auxiliary tables, etc. These algorithms and/or setting values can be stored, for example, in a memory device of the computer system.

In some embodiments, the user may be required to actively confirm or reject the changed setting. Suitable input options, such as a Save or Cancel button, may be provided for this purpose.

Confirmation can be a simple click of an “OK” button or something similar.

In some embodiments, the first output interface is preferably a visual or graphical interface for the user, is connected to such an interface, or includes such an interface.

In some embodiments, the output interface is or includes a common interface with a control or regulating device of the blood treatment device.

In some embodiments, the computer system is a mobile device, handheld device, cell phone, smartphone, tablet, etc., or at least includes one such device.

In some embodiments, the computer system is a fixed computer terminal, a desktop computer, etc., or at least comprises such a device. In these embodiments, it can be provided, for example, in a central monitoring room, in particular an intensive care unit.

In some embodiments, the computer system comprises a computer program or an application (short: app) that can be loaded onto such a mobile device or other device or is stored, can be executed, is executed or runs on such a device.

In some embodiments, the technical parameter values determined by the computing device are or include a setting value for the blood pump and a setting value for the dialysis fluid pump, e.g., target values and/or flow rates. In other words, in these embodiments, the computing device is programmed to display or otherwise output the setting value for the blood pump and the setting value for the dialysis fluid pump, which were determined or calculated based on changing the preset value of the target treatment parameter or by entering a treatment specification, to the user as technical parameter values, or as a part thereof, by means of the display device via the first output interface for information purposes.

In some embodiments, the computer system according to the invention is a control or regulating device of the blood treatment device or a part thereof or is in signal communication therewith.

In some embodiments, the computer system according to the invention is implemented in or connected to a control or regulating device of a blood treatment device, whereby the blood treatment device is or would be configured to form a blood treatment device according to the invention. In these embodiments, existing input and output interfaces and the computing device of the blood treatment device can be advantageously used to implement the computer system according to the invention.

In some embodiments, the computer system may be or include a server-based solution in which the user can call a program running on a server, for example, via a website, to execute or initiate the steps of the method described herein. The computer system may thus optionally include a server. It may include user interfaces and/or user terminals such as computers, mobile phones, or tablets configured to communicate with the server.

In some embodiments, the output interface and the display device may be identical. Output via the output interface may thus be display via the display device, and vice versa.

In some embodiments, the blood treatment device according to the invention comprises a control device which is prepared for receiving the setting values transmitted by signal transmission.

In some embodiments, the blood treatment device for extracorporeal blood treatment of a patient is designed as a dialysis device, hemodialysis device, hemofiltration device or hemodiafiltration device, in particular as a device for acute, chronic renal replacement therapy or for continuous renal replacement therapy (CKRT).

In some embodiments of the blood treatment device, the computer system is part of the control device and/or the output device is the display of the blood treatment device.

In some embodiments of the computer-implemented method, the setting values include pumping rates, ultrafiltration volumes, pressures, limits of pressure ranges to be monitored, compositions of solutions used for treatment, and/or the like.

In some embodiments of the computer-implemented method, the input values comprise one or more blood parameters such as electrolyte concentrations and/or other values characterizing the treated patient such as body weight, body surface area and/or estimated volume of distribution.

In some embodiments, the present invention can provide support. For example, it is envisaged that the user can be supported by setting (possibly on a trial basis) various sodium concentrations, for example for the solutions used, such as substituate, dialysis fluid, etc. (possibly via a drop-down menu or other suitable display), and can choose the option that appears most suitable.

In some embodiments, the computer system or the computer-implemented method allows the user to enter a sodium target value for the patient's blood (e.g., in 12 hours from the start of treatment, as a desired sodium change per hour, or similar) and suggestions regarding suitable setting values, solutions to be used or their concentrations and/or rates are brought to the attention of the user or for selection.

In certain embodiments, the input values include patient measurements, for example, a sodium value from a blood gas analysis, a hematocrit measurement (also known as Hc, Hct or Hkt), or the like.

In some embodiments of the computer-implemented method, this comprises comparing the predicted value or course with real treatment data that become known later, possibly with a reference to the user regarding possible deviations between the prognosis and the real course, preferably including optional, conceivable explanations for the cause of the deviation, or supports the user in doing so or thereby.

In some embodiments of the method, the input values further comprise measured or otherwise collected values of the patient's at least one blood parameter collected before the start of the method and/or treatment session.

• - Natriumkonzentration oder Natriumionenkonzentration
• - Kreatin, Harnstoff, Bicarbonat, Kalium, Calcium, Glucose, Chlorid, Hämatokrit
• - pCO₂, pH, HCO₃ ^-, BE (Basenüberschuss) , pO₂, SpO₂, SaO2 (arterielle Sauerstoffsättigung)

In some embodiments of the method, the measured or otherwise collected values of the patient's blood parameter include one or more of the following blood parameters:

• - Sodium concentration or sodium ion concentration
• - Creatine, urea, bicarbonate, potassium, calcium, glucose, chloride, hematocrit
• - pCO ₂ , pH, HCO ₃ ^- , BE (base excess), pO ₂ , SpO ₂ , SaO2 (arterial oxygen saturation)

In some embodiments of the method, the input values further comprise measured or otherwise collected values of the patient's blood parameter collected after the start of the method or treatment session.

In some embodiments of the computer-implemented method, a statement about the condition of a blood filter used for blood treatment is made according to predetermined rules based on the predicted value or progression of the blood parameter. This is done in particular in comparison with a value of the patient's blood parameter measured or otherwise collected, preferably after the start of the method or treatment session.

In some embodiments of the method, a condition of a blood filter used for blood treatment is predicted for at least one point in time according to predetermined rules based on the predicted value or progression of the blood parameter. This is done in particular in comparison with a value of the patient's blood parameter measured or otherwise collected, preferably after the start of the method or treatment session.

In some embodiments of the method, the predicted value or curve is measured against limit values or ranges or reference values or ranges, compared with them and/or displayed as a function thereof.

In certain embodiments, deviations from the predicted value or trend can be used to draw conclusions about possible conditions of the patient and/or the blood filter. The user can be informed of the results of these conclusions.

In some embodiments of the method, the predicted value or profile of the at least one blood parameter is received and output by means of an output device in signal connection with the output interface.

In some embodiments, the method comprises proposing at least one change to at least one setting value according to predetermined rules based on the value or progression of the predicted value such that when this setting value is set, the subsequently re-predicted or predictable value or progression of the at least one blood parameter lies between limit values or within limit ranges or between reference values or within reference ranges.

In some embodiments of the method, the computer system further comprises a blood treatment device with a control device, wherein setting values are transmitted to the control device via signal transmission.

In some embodiments of the computer-implemented method, the control device controls or regulates the blood treatment device based on the setting values transmitted via signal transmission.

In some embodiments, instead of a patient's blood parameter, a preferably inert test substance or its concentration profile is observed. This test substance can be injected into the extracorporeal bloodstream, for example, at a designated injection site, e.g., as a bolus dose. Such a substance can be, for example, icodextrin. An analysis of the step response, or in other words, what of the substance is removed across the membrane of the blood filter, can also provide an indication of the functionality of the blood filter or allow conclusions to be drawn about it.

The following example illustrates how the computer system might function using sodium as a reference blood parameter in conjunction with regional citrate anticoagulation. Since the administration of trisodium citrate results in additional sodium being introduced into the patient's blood, this example places increased demands on the computer system compared to other reference blood parameters that are not additionally administered to the patient as part of the therapy.

The computer system determines, e.g., calculates, the amount of sodium (amount of substance to be dialyzed) to be removed between the blood inlet and the blood outlet in order to achieve the goal of reinfusing the patient with the same blood sodium concentration as the blood drawn from the patient for treatment, unless a specific target deviation is desired. This can be taken into account that in the event of a negative volume balance, sodium will be removed from the patient accordingly.

The computer system also determines or calculates the amount of sodium that can be dialyzed (amount of substance that can be dialyzed) under the selected setting values (device flow conditions).

The comparison between the amount of sodium to be dialyzed and the amount that can be dialyzed indicates whether the sodium concentration in the patient's blood is likely to rise or fall. The patient-dependent distribution volume (total body water) is taken into account, as is known from the state of the art, for example, according to the well-known Watson formula.

The computer system determines the changing concentration (in this example, sodium) in the patient's blood over the desired period and displays the corresponding values graphically, e.g., over a time axis. If the actual patient measurements for the reference substance, in this case sodium, are also stored in the computer system, these values can also be displayed graphically.

By comparing the prognosis with the actual patient measurements, medical staff can determine whether the dialyzer is still fully functional or when, for example, a reduced exchange capacity of the dialyzer membrane will set in, due to the clogging described above. In such a case, the prognosis and actual patient measurements diverge (particularly in a scissor-like manner).

wobei

QBein

die Rate (oder der Fluss) der in den Blutfilter einlaufenden Flüssigkeit in der Einheit [ml/min];

QBMaschine

die Rate der von der Maschinenpumpe geförderten Flüssigkeit in der Einheit [ml/min)]; und

Qcitrat

die Rate, mit welcher Citratlösung in der Einheit [ml/min] zudosiert wird, ist.

In some embodiments, the blood flow conditions can be described as follows: $$\begin{array}{c}{\text{QB}}_{\text{ein}}={\text{QB}}_{\text{Maschine}}\\ ={\text{QB}}_{\text{Patient}}+{\text{Q}}_{\text{Citrat}}\end{array}$$

where

QBein

the rate (or flow) of fluid entering the blood filter in units [ml/min];

QBMachine

the rate of fluid delivered by the machine pump in units [ml/min]; and

Qcitrate

is the rate at which citrate solution is added in units of [ml/min].

The rate of added citrate solution Q _citrate can also be described here as citrate dosage divided by the citrate concentration of the citrate solution multiplied by QB _ein .

wobei

HcPatient

der Hämatokrit des Patienten, dimensionslos;

QBPatient

die Rate des vom Patient an den Blutfilter gelieferte Bluts in der Einheit [ml/min];

CNaCitrat

die Natriumkonzentration der Citratlösung in der Einheit [mmol/l]; und

CNaPatient

die beim Patienten im Blut gemessene Natriumkonzentration in der Einheit [mmol/l] ist.

The amount of sodium Na _blood flowing into the blood filter per minute can therefore be expressed in the unit [mmol/min] as follows: $${\text{Na}}_{\text{Blutein}}=\left(1-{\text{Hc}}_{\text{Patient}}\right)*{\text{QB}}_{\text{Patient}}\text{/}1000*{\text{C}}_{\text{NaPatient}}+{\text{Q}}_{\text{Citrat}}\text{/}1000*{\text{c}}_{\text{NaCitrat}}$$

where

HcPatient

the patient's hematocrit, dimensionless;

QBPatient

the rate of blood delivered by the patient to the blood filter in units [ml/min];

CNaCitrate

the sodium concentration of the citrate solution in units [mmol/l]; and

CNaPatient

the sodium concentration measured in the patient's blood in the unit [mmol/l].

When specifying the hematocrit as a percentage, the corresponding decimal value should be inserted into the formula, e.g., for 35% hematocrit, the numerical value in the formula would be 0.35.

cBeinNa

kann optional so korrigiert werden, dass erwartbare Wasserverschiebungen zwischen Blutzellen und dem Plasma und/oder zwischen anderen Kompartimenten oder Verteilungsräumen berücksichtigt werden.

Furthermore, the sodium concentration c _Beinua , of the fluid flowing into the blood filter (ie into its blood chamber), i.e. the sodium concentration of Q _Bein , can be determined as follows (unit [mmol/l]): $${\text{c}}_{\text{BeinNa}}={\text{Na}}_{\text{Blutein}}\text{/}\left(\left(1-{\text{Hc}}_{\text{Patient}}\right)\cdot {\text{QB}}_{\text{Patient}}\text{/}1000+{\text{Q}}_{\text{Citrat}}\text{/}1000\right)$$

cBeinNa

can optionally be corrected to take into account expected water shifts between blood cells and plasma and/or between other compartments or distribution spaces.

wobei

QDaus

die Rate der auf der Dialysatseite aus dem Blutfilter ausströmenden Dialysierflüssigkeit in der Einheit [ml/min];

QDein

die Rate der auf der Dialysatseite in den Blutfilter einströmenden Dialysierflüssigkeit in der Einheit [ml/min]; und

QFgesamt

die Rate der gesamten im Blutfilter über die Membran von der Blutseite entzogenen Flüssigkeit in der Einheit [ml/min] ist.

On the dialysate side (i.e. into or out of the dialysis fluid chamber), the resulting flows can be described as follows: $${\text{QD}}_{\text{aus}}={\text{QD}}_{\text{ein}}+{\text{QF}}_{\text{gesamt}}$$

where

QDaus

the rate of dialysis fluid flowing out of the blood filter on the dialysate side in units [ml/min];

QYour

the rate of dialysis fluid flowing into the blood filter on the dialysate side in units of [ml/min]; and

QFtotal

is the rate of total fluid removed from the blood side in the blood filter via the membrane in the unit [ml/min].

As a rule, the rate of dialysis fluid flowing into the blood filter on the dialysate side QD _in (unit [ml/min]) and the sodium concentration of the incoming dialysis fluid c _DiainNa (unit [mmol/l]) are known.

From this, the amount of sodium Na _Diaein flowing into the blood filter per minute on the dialysate side can be determined in the unit [mmol/min]: $${\text{Na}}_{\text{Diaein}}={\text{QD}}_{\text{ein}}\text{/}1000\cdot {\text{C}}_{\text{DiaeinNa}}$$

The amount of sodium removed by diffusion Na _diff per minute, assuming a functioning blood filter, is as follows (unit [mmol/min]): $${\text{Na}}_{\text{diff}}={\text{QD}}_{\text{ein}}\text{/}1000\cdot \left({\text{c}}_{\text{BeinNa}}-{\text{c}}_{\text{DiaeinNa}}\right)$$

For the convectively removed sodium amount Na _conv per minute (unit [mmol/min]) under the same assumption: $${\text{Na}}_{\text{konv}}={\text{QF}}_{\text{gesamt}}\text{/}1000\cdot {\text{c}}_{\text{BeinNa}}$$

This results in a total (diffusively and convectively) removed amount of sodium Na _ges , also in the unit [mmol/min] : $${\text{Na}}_{\text{ges}}={\text{Na}}_{\text{diff}}+{\text{Na}}_{\text{konv}}$$

Assuming that the dialysate leaving the blood filter on the dialysate side is saturated to the blood inlet concentration, the amount of sodium leaving the blood filter on the _dialysate side per minute can be expressed using the following formula (unit [mmol/min]): $${\text{Na}}_{\text{Diaaus}}={\text{QD}}_{\text{aus}}\text{/}1000\cdot {\text{c}}_{\text{BeinNa}}$$

mit

QFPatient =

die dem Patientenblut im Blutfilter entzogenen Flüssigkeit in [ml/min]

QFCitrat = QCitrat =

die Rate der zudosierten Citratlösung in [ml/min]

QFCalcium =

die dem Patientenblut nach dem Blutfilter zudosierte Rate an Calciumlösung in [ml/min] unter der Annahme, dass die Calciumlösung kein Natrium enthält (andernfalls wäre diese als Natriumquelle zu berücksichtigen);

Furthermore: $$Q{F}_{\text{gesamt}}=Q{F}_{\text{patient}}+Q{F}_{\text{citrat}}+Q{F}_{\text{calcium}}$$

with

QFPatient =

the fluid removed from the patient's blood in the blood filter in [ml/min]

QFCitrate = QCitrate =

the rate of added citrate solution in [ml/min]

QFCalcium =

the rate of calcium solution added to the patient's blood after the blood filter in [ml/min], assuming that the calcium solution does not contain sodium (otherwise it would have to be considered as a sodium source);

The amount of sodium that is transported per minute by the incoming dialysis fluid (unit [mmol/min]) is calculated as follows: $${\text{Na}}_{\text{Diaweg}}\left[\text{mmol}/\text{min}\right]={\text{Na}}_{\text{Diaaus}}-{\text{Na}}_{\text{Diaein}}$$

wobei

QCalcium

die Rate der stromabwärts des Blutfilters zudosierten Calciumlösung ist.

On the blood side, the prevailing flow rates from the blood filter result _in a fluid flow QB flowing back to the patient (unit [ml/min]): $$Q{B}_{\text{aus}}=Q{B}_{\text{ein}}-Q{F}_{\text{gesamt}}+Q_{\text{Calcium}}$$

where

QCalcium

is the rate of calcium solution added downstream of the blood filter.

mit $$Q{B}_{\text{einPlasma}}=\left(1-{\text{Hc}}_{\text{Patient}}\right)\cdot Q{B}_{\text{Patient}}$$

und $$Q{B}_{\text{ausPlasma}}=\left(1-{\text{Hc}}_{\text{Patient}}\right)\cdot Q{B}_{\text{Patient}}-Q{F}_{\text{Patient}}$$

wobei

NaBlutaus

die Natriummenge ist, die blutseitig pro Minute aus dem Blutfilter ausläuft in der Einheit [mmol/min]; und

QFPatient

die Rate des Flüssigkeitsvolumens mit dem der Patient entwässert wird in der Einheit [ml/min] ist.

The fluid flowing back to the patient has a sodium concentration C _PatientNa in [mmol/l]. If the patient is not to experience a change in concentration, the amount of sodium Na to be removed (dialyzed) per minute _{from the bloodstream} (unit [mmol/min]) is calculated as follows: $$\begin{array}{c}{\text{Na}}_{\text{Blutweg}}={\text{Na}}_{\text{Buletin}}-{\text{Na}}_{\text{Blutaus}}\\ =\left(Q{B}_{\text{einPlasma}}/1000\cdot {\text{C}}_{\text{NaPatient}}+Q_{\text{Citrat}}/1000\cdot {\text{C}}_{\text{NaCitrat}}\right)-\\ \left(Q{B}_{\text{ausPlasma}}/1000\cdot {\text{C}}_{\text{NaPatient}}\right)\end{array}$$

with $$Q{B}_{\text{einPlasma}}=\left(1-{\text{Hc}}_{\text{Patient}}\right)\cdot Q{B}_{\text{Patient}}$$

and $$Q{B}_{\text{ausPlasma}}=\left(1-{\text{Hc}}_{\text{Patient}}\right)\cdot Q{B}_{\text{Patient}}-Q{F}_{\text{Patient}}$$

where

NaBlutaus

is the amount of sodium that flows out of the blood filter per minute in the unit [mmol/min]; and

QFPatient

is the rate of fluid volume at which the patient is drained in units of [ml/min].

For a sodium concentration change Δ _NaPatient per hour in the patient, the result is: $${\Delta }_{\text{Na Patient}}=\left({\text{Na}}_{\text{Bweg}}-{\text{Na}}_{\text{Diaweg}}\right)\cdot 60/\text{Verteilungsvolumen}$$

The volume of distribution is calculated, for example, using the Watson formula (Total Body Water).

In certain embodiments, the present formulas and considerations can be used by the computer system to predict the blood parameter or test parameter, here using sodium as an example.

The present formulas contain approximations typically permissible for CKRT. Those skilled in the art can easily extend the formulas used to include additional aspects to achieve more precise modeling if necessary. The possibility of such extensions is also disclosed.

The above formula set only applies to continuous veno-venous hemodialysis (CVVHD) with citrate anticoagulation. For extensions to continuous veno-venous hemodiafiltration (CVVHDF), the substituate flow would also have to be included in the formulas. If switching to continuous veno-venous hemofiltration (CVVH) with one or more substituate flows but no dialysate flow, the formula set would also have to be adjusted. In these cases, the outflowing dialysate would be clinically referred to as filtrate, or effluent would be chosen as the generic term.

Whenever reference is made to “programmed” or “configured,” it is also disclosed that these terms may be used interchangeably.

Some or all embodiments of the invention may have one, several or all of the advantages mentioned above and/or below.

An advantage of the present invention may be the possibility of displaying the expected development of the relevant blood parameters over a longer period of time (for example, 72 hours or more) before the start of treatment by entering and evaluating the intended setting values.

A further advantage of the present invention may be that medical personnel can conduct various simulations and, if necessary, once they have gained an overview of the expected course of treatment, can make new settings on the blood treatment device, which directs the course of blood treatment in the desired direction for the patient. This significantly increases patient safety, especially for intensive care patients, since adjustments to the electrolyte balance of the patient's blood need to be made neither too quickly nor too slowly.

Furthermore, a further advantage of the present invention may be that medical personnel can be alerted early on to developments that are dangerous for the patient. Examples include the detection of a change in blood parameters that indicates inadequate citrate metabolism or the detection of significant calcium depletion, which indicates bone demineralization.

The fact that medical staff then have the opportunity to view the predicted consequences of possible countermeasures or adjustments, particularly graphically over time, and to study and evaluate this display can be a further advantage. Based on the predicted values and/or the predicted progression with adjustment of the machine parameters, clinical staff can particularly advantageously determine when the desired correction is likely to be achieved or whether the desired correction can be achieved in time with the selected settings. This also significantly increases patient safety.

An increasing deviation of values, for example the sodium level, from the simulation can also give medical personnel an indication of the risk of a non-functional blood filter (particularly due to "clogging"), since the optimal function of the blood filter assumed in the simulation is no longer present. In "clogging," the fiber membrane is coated with a layer, the inner diameter of the hollow fibers affected by "clogging" is smaller than normal, and the exchange through the membrane is disrupted. Detection of this suboptimal function, especially at an early stage, can represent a further advantage of the present invention. Advantageously, countermeasures can then be taken in a timely manner or a timely replacement of the blood filter can be planned. This can also contribute to patient safety and also help save time and costs.

A further advantage of the present invention may be that early detection of maldevelopments due to possibly incorrectly or inadequately selected treatment parameters or “clogging” contributes to a higher quality of treatment and leads to a better patient outcome.

The present invention can further be used advantageously for education and training purposes, for example to anticipate life-threatening scenarios in a digital safe space for the benefit of a patient and to avoid errors in reality, as well as for simulation purposes.

Selecting targeted and individualized treatment parameters for continuous renal replacement therapy is difficult in these cases and requires years of experience and highly specialized expertise in treating such patients and operating the blood treatment device for continuous renal replacement therapy. The present invention can help to anticipate the effect of selecting specific settings for certain treatment parameters by reviewing the predicted values or progressions.

This can also indirectly increase patient safety.

However, the responsibility for determining or changing the settings can advantageously remain with the user. The user thus receives valuable support from the computer system according to the invention, but cannot be surprised by its unauthorized actions.

If the blood treatment device and computer system remain separate devices, existing blood treatment devices can be combined with the computer system according to the invention to form the system according to the invention. Since interventions in the control system of the blood treatment device are not required, the blood treatment device does not require re-approval as a medical device.

• 1 zeigt in stark vereinfachter Darstellung ein erfindungsgemäßes Computersystem;
• 2 zeigt schematisch vereinfacht einen Fluidleitungsaufbau einer erfindungsgemäßen Blutbehandlungsvorrichtung in einer beispielhaften Ausführungsform;
• 2a zeigt schematisch vereinfacht einen Fluidleitungsaufbau einer erfindungsgemäßen Blutbehandlungsvorrichtung in einer weiteren Ausführungsform;
• 3a zeigt eine exemplarische Ausgabe des Ergebnisses einer Prognose mittels des erfindungsgemäßen Computersystems bei einem normalen Verlauf einer Behandlung;
• 3b zeigt eine exemplarische Ausgabe des Ergebnisses einer Prognose mittels des erfindungsgemäßen Computersystems bei einem zunächst suboptimalen Verlauf einer Behandlung;
• 3c zeigt eine exemplarische Ausgabe des Ergebnisses einer Prognose mittels des erfindungsgemäßen Computersystems bei Auftreten einer mangelnden Funktionalität des Blutfilters („clogging“); und
• 4 zeigt schematisch vereinfacht einen exemplarischen Ablauf eines erfindungsgemäßen Verfahrens.

The present invention is explained below by way of example with reference to the accompanying drawings, in which like reference numerals designate identical or similar components. In the figures of the drawing:

• 1 shows a highly simplified representation of a computer system according to the invention;
• 2 shows a simplified schematic view of a fluid line structure of a blood treatment device according to the invention in an exemplary embodiment;
• 2a shows a simplified schematic view of a fluid line structure of a blood treatment device according to the invention in a further embodiment;
• 3a shows an exemplary output of the result of a prognosis using the computer system according to the invention during a normal course of treatment;
• 3b shows an exemplary output of the result of a prognosis using the computer system according to the invention in the case of an initially suboptimal course of treatment;
• 3c shows an exemplary output of the result of a prognosis using the computer system according to the invention when a lack of functionality of the blood filter (“clogging” occurs); and
• 4 shows a simplified schematic of an exemplary sequence of a method according to the invention.

1 shows a highly simplified representation of a computer system 1 according to the invention, which assists a user, e.g. a doctor, in the preparation or implementation of a blood treatment device 100 (see 2 ) blood treatment session of a patient.

The computer system according to the invention comprises a computing device 5, an input interface 501 and an output interface 503.

The input interface 501 is configured to enter/read or read input values.

Such input values can, for example, be entered by the user via an input device 500, for example a touchscreen monitor, a touchscreen display or the like. In other embodiments, the input interface 501 can read the input values from a blood treatment device 100 or its control device 150 or read them in via such a device (in 1 not shown), read or input from a central unit ZE, for example a cloud, and/or read or input from another device of the computer system intended and suitable for this purpose.

The input values read in or out as above comprise at least setting values of machine parameters of a blood treatment device 100 for extracorporeal blood treatment of the patient in the treatment session (see 2 ).

The computing device 5 is programmed to predict, based on the input of the input values, at least one value resulting at a time during the treatment session, or a course resulting over a period of time during the treatment session, for at least one blood parameter of the patient.

In addition, the computing device 5 is programmed to transmit the predicted value or curve to a unit beyond the computing device 5, for example the output interface 503, by means of signal transmission, in order to subsequently output this via an output device 505, in the example the 1 a display of the computer system 1.

The output of the predicted value or the predicted course of the blood parameter(s) is intended for the information or evaluation by the user, for his/her orientation and/or for the monitoring of the patient, his/her treatment and/or the treatment session by the user, for example medical personnel.

In some embodiments, the predicted value or the predicted course is used to calculate adjusted, new setting values for controlling a blood treatment device, calculated by the computer system of the blood treatment device or suggested by the user.

Such adjusted setting values can also be transmitted to the output interface 503 for subsequent output via an output device 505.

In some embodiments, such adjusted setting values can be transmitted automatically or semi-automatically, for example after confirmation by the user, to the control device 150 of the blood treatment device 100 (see 2 ) in order to use the adjusted setting values to also adapt or change the corresponding machine parameters of a blood treatment device 100 for extracorporeal blood treatment of the patient before or during the treatment session.

Setting values may include, among others, the following machine parameters, e.g., the pumping rates of the existing pumps, ultrafiltration volumes, heating rates, sodium and/or bicarbonate concentration in the dialysis fluid, treatment modes, and/or the like.

In some embodiments, the input values further comprise measured or otherwise collected values of at least one blood parameter of the patient, collected before the start of the procedure or treatment session.

• - Natriumkonzentration oder Natriumionenkonzentration
• - Kreatin, Harnstoff, Bicarbonat, Kalium, Calcium, Glucose, Chlorid, Hämatokrit
• - pCO₂, pH, HCO₃ ^-, BE (Basenüberschuss) , pO₂, SpO₂, SaO2 (arterielle Sauerstoffsättigung)

The blood parameter(s) may include one or more of the following blood parameters:

• - Sodium concentration or sodium ion concentration
• - Creatine, urea, bicarbonate, potassium, calcium, glucose, chloride, hematocrit
• - pCO ₂ , pH, HCO ₃ ^- , BE (base excess), pO ₂ , SpO ₂ , SaO2 (arterial oxygen saturation)

In some embodiments, the input values further comprise measured or otherwise collected values of the patient's at least one blood parameter, collected after the start of the procedure or treatment session. These may have been entered by the user using the input device via the input interface.

The computer system 1 can be further programmed to make a statement about the condition of a blood filter 303 used for blood treatment according to predetermined rules based on the predicted value or predicted course of the at least one blood parameter (see 2 ) at the time of the forecast.

The computer system 1 can be further programmed to predict a state of a blood filter 303 used for blood treatment for at least one point in time in the future according to predetermined rules based on the predicted value or predicted course of the at least one blood parameter.

The computer system 1 can, in turn, be in signal connection with a central unit ZE, here, for example, a cloud, represented by a dashed double arrow, or include this. The central unit ZE can alternatively or additionally also be in direct signal connection with the control device 150 (in 1 not shown).

2 shows a simplified schematic view of a fluid line structure of a blood treatment device 100 according to the invention in an exemplary embodiment.

The blood treatment device 100, which is shown in an at least partially upgraded state of use, is connected to an extracorporeal blood circuit 300, which can be used for treatment by means of double-needle access, or using, for example, an additional Y-connector (reference symbol Y), as in 2 shown, can be connected to the vascular system of the patient (not shown) via single-needle access or via a central venous catheter and optionally does not belong to the blood treatment device 100, but in other embodiments does. The blood circuit 300 can optionally be present in sections thereof in or on a blood cassette.

Pumps, actuators and/or valves in the area of the blood circuit 300 are connected in a signal connection to the blood treatment device 100 according to the invention or to a control device 150 comprised therein, for example, where necessary for control or regulation.

The blood circuit 300 includes (or is connected to) an arterial patient tube clamp 302 and an arterial connection needle of an arterial section or an arterial patient line, blood collection line, or first line 301. The blood circuit 300 further includes (or is connected to) a venous patient tube clamp 306 and a venous connection needle of a venous section, a venous patient line, blood return line, or second line 305.

A blood pump 101 is provided in or on the first line 301. A substituate pump 111 is connected to a dialysis fluid supply line 104 for conveying fresh dialysis fluid, which is filtered in a further filter stage F2 (substituate). A substituate line 105 can be fluidically connected to the dialysis fluid supply line 104. By means of the substituate pump 111, substituate can be introduced by pre-dilution, via a pre-dilution valve 107, or by post-dilution, via a post-dilution valve 109, via associated lines 107a or 109a into line sections, for example into the arterial line section 301 or into the venous line section 305 (here between a blood chamber 303b of a blood filter 303 and a venous air separation chamber or a venous bubble trap 329) of the blood circuit 300.

The blood filter 303 has the blood chamber 303b connected to the arterial line section 301 and to the venous line section 305. A dialysis fluid chamber 303a of the blood filter 303 is connected to the dialysis fluid inlet line 104 leading to the dialysis fluid chamber 303a and to a dialysate outlet line 102 leading away from the dialysis fluid chamber 303a, which carries dialysate, i.e., used dialysis fluid. Suitable connectors are provided for this purpose on the dialysis fluid inlet line 104 and the dialysate outlet line 102, respectively, on the one hand, and on the dialyzer ports, on the other hand, which connectors can be connected to one another, in particular detachably.

Dialysis fluid chamber 303a and blood chamber 303b are separated from each other by a mostly semi-permeable membrane 303c. This represents the separating wall between the blood side with the extracorporeal blood circuit 300 and the machine side with the dialysis fluid or dialysate circuit, which in 2 shown to the left of the membrane 303c.

The arrangement of the 2 further comprises a valve V24, which is arranged in the dialysis fluid supply line 104 upstream of the blood filter 303, but downstream of a pressure sensor PS5. It further comprises a valve V25, which is arranged in the dialysate outlet line 102, downstream of the blood filter 303, but upstream of another pressure sensor PS4.

The arrangement of the 2 includes an optional detector 315 for detecting air and/or blood. The arrangement of the 2 further comprises one or two pressure sensors PS1 (upstream of the blood pump 101) and PS2 (downstream of the blood pump 101, it measures the pressure upstream of the blood filter 303 (“pre-hemofilter”)) at the 2 shown locations. Additional pressure sensors may be provided, e.g., pressure sensor PS3 downstream of venous bubble trap 329.

Blood leaving the blood filter 303 flows through the optional venous bubble trap 329, which may have a venting device 318 and may be in fluid communication with the pressure sensor PS3.

An optional single-needle chamber 317 comes in 2 as a buffer and/or compensation container in a single-needle procedure in which the patient is connected to the extracorporeal blood circuit 300 by means of only one of the two blood lines 301, 305.

The arrangement of the 2 also includes an optional detector 319 for detecting air bubbles and/or blood.

An addition site 325 for heparin or another anticoagulant may be provided optionally.

Links in 2 A mixing device 163 is shown, which provides a predetermined mixture for the respective solution for use by the blood treatment device 100 from containers A (for A concentrate via concentrate supply 166) and B (for B concentrate via concentrate supply 168). The solution contains water from the water source 155 (online, e.g., as reverse osmosis water or from bags), which is heated, e.g., in the heating device 162.

A pump 171, which can be referred to as a concentrate pump or sodium pump, is fluidly connected to and/or pumps from the mixing device 163 and a source of sodium, such as container A. An optional pump 173, which is assigned to container B, such as for bicarbonate, can be seen.

Further on, 2 An outlet 153 for the effluent can be seen. An optional heat exchanger 157 and a first flow pump 159, suitable for degassing, complement the arrangement shown.

The pressure sensor PS4 downstream of the blood filter 303 on the water side, but preferably upstream of the ultrafiltration pump 131 in the dialysate drain line 102, can be provided for measuring the filtrate pressure or membrane pressure of the blood filter 303.

The 2 The exemplary arrangement shown shows the control device 150. The latter can be in wired or wireless signal connection with each of the components mentioned herein - in any case or in particular with the blood pump 101 - for controlling or regulating the blood treatment device 100.

Using the device for online mixing of the dialysis fluid, it is possible to vary its sodium content within certain limits, controlled by the control device 150. For this purpose, the measured values determined by conductivity sensors 163a, 163b can be incorporated. Should an adjustment of the sodium content of the dialysis fluid (sodium concentration) or of the substituate prove necessary or desired, this can be achieved by adjusting the delivery rate of the sodium pump 171.

Furthermore, the blood treatment device 100 comprises means for conveying fresh dialysis fluid and dialysate. A first valve can be provided between the first flow pump 159 and the blood filter 303, which opens or closes the inlet to the blood filter 303 on the inlet side. A second, optional flow pump 169 is provided, for example, downstream of the blood filter 303, which conveys dialysate to the outlet 153. A second valve can be provided between the blood filter 303 and the second flow pump 169, which opens or closes the outlet on the outlet side.

Furthermore, the blood treatment device 100 optionally comprises a device 161 for balancing the flow flowing into and out of the dialyzer 303 on the machine side. The balancing device 161 is preferably arranged in a line region between the first flow pump 159 and the second flow pump 169.

The blood treatment device 100 further comprises means for precisely removing a volume of liquid specified by the user and/or by the control device 150 from the balanced circuit, such as the ultrafiltration pump 131.

Sensors such as the optional conductivity sensors 163a, 163b are used to determine the conductivity, which in some embodiments is temperature compensated, as well as the fluid flow upstream and downstream of the dialyzer 303.

Temperature sensors 165a, 165b can be provided individually or in groups. According to the invention, the temperature values they provide can be used to determine a temperature-compensated conductivity.

An optional compressed air source 175, for example in the form of a compressor, can be provided on the machine side upstream of the blood filter 303.

A leakage sensor 167 is provided as an option. It can also be installed elsewhere.

Further flow pumps, in addition to or as an alternative to, for example, that with the reference numeral 169, may also be provided.

A range of optional valves is available in 2 each marked with V. Bypass valves are marked with VB.

Based on the measured values of the aforementioned optional sensors, in some embodiments, the control device 150 determines the electrolyte and/or fluid balance.

Filters F1 and F2 can be connected in series.

The filter F1 serves here as an example to produce sufficiently pure dialysis fluid by means of the mixing device 163 even using non-pure water, which then flows through the blood filter 303, e.g. in the countercurrent principle.

The filter F2 serves here as an example to generate sterile or sufficiently filtered substituate from the sufficiently pure dialysis fluid that leaves the first filter F1 by filtering out, for example, pyrogenic substances, which can be safely added to the patient's extracorporeal blood and thus ultimately to the patient's body.

The blood treatment device 100 is in 2 Although shown optionally as a device for hemo(dia)filtration, hemodialysis devices also fall within the scope of the present invention, even though they are not specifically illustrated by the figure.

The 2 The arrowheads shown generally indicate the direction of flow.

Furthermore, the control device 150 is connected to the computer system 1 according to the invention, which in the example of 2 may be physically separated from the blood treatment device 100, in a wired or preferably wireless signal connection (in 2 generally represented as dashed double arrows) for retrieving or sending data, such as setting values and/or forecast data.

The control device 150 can be configured to receive the setting values transmitted via signal transmission from the computer system 1. Alternatively or additionally, it can be programmed to control or regulate the blood treatment device 100 based on the setting values transmitted via signal transmission.

The blood treatment device 100 according to the invention in the example of 2 further comprises a display 160, which is optionally provided and configured for interaction with the user and/or for providing information to the user. The display 160 can be the output device and/or the input device.

2a shows a simplified schematic view of a fluid line structure of an exemplary blood treatment device 100 according to the invention in a further embodiment, in particular as used for acute dialysis.

The medical treatment device 100 is optionally connected to an extracorporeal blood circuit 300 and further optionally to an effluent bag 400.

The extracorporeal blood circuit 300 has a first line 301, here in the form of an arterial line section.

The first line 301 is optionally in fluid connection with a blood treatment device, here exemplarily a blood filter or dialyzer 303, which is exemplarily as to 2 can be designed in an executed manner.

The extracorporeal blood circuit 300 further comprises at least one second line 305, here in the form of a venous line section. Both the first line 301 and the second line 305 can serve to connect it to the vascular system of the patient (not shown).

The first line 301 is optionally connected to a (first) hose clamp 302 for blocking or closing the line 301. The second line 305 is optionally connected to a (second) hose clamp 306 for blocking or closing the line 305.

The 2a The medical treatment device 100, represented schematically only by some of its features, has a blood pump 101. During the patient's treatment, the blood pump 101 pumps blood through sections of the extracorporeal blood circuit 300 and toward the blood filter or dialyzer 303, as indicated by the small arrowheads. Prior to a treatment session, the blood pump 101 serves to fill and flush parts of the medical treatment device 100 and sections of the extracorporeal blood circuit 300 with fluid.

By means of a first flow pump 159, which can be configured in particular as a volumetric pump, fresh, ready-to-use dialysis fluid, e.g., from a container 200, is pumped through or along the dialysis fluid supply line 104 toward the blood filter 303. The first container 200 can, for example, be a bag or a container.

The dialysis fluid supply line 104 opens downstream into the dialysis fluid chamber 303a of the blood filter 303. The dialysis fluid chamber 303a of the blood filter 303 is separated from a blood chamber 303b of the blood filter 303 by a semi-permeable membrane 303c.

The dialysis fluid leaves the dialysis fluid chamber 303a as dialysate, possibly enriched with filtrate, via the dialysate drain line 102 toward the optional effluent bag 400 or toward a spout and is referred to herein as the effluent. A second flow pump 169 for conveying the dialysate or effluent through or along the dialysate drain line 102 may be provided, as may an optional pressure sensor PS3.

The elements and features discussed below can be provided optionally, in any combination of elements and/or features. They can also be omitted individually or in any combination, unless deemed indispensable by a person skilled in the art for a specific combination of features.

From the optional effluent bag 400, the effluent can be discarded into a sink via an effluent drain line. In some embodiments, the effluent is discarded directly into a sink via the dialysate drain line 102 (not shown here).

The dialysis fluid supply line 104 of the 1 Optionally, the device comprises or is connected to a heating bag. The heating bag is inserted into a heating device 162 to supply heated dialysis fluid to the blood filter 303. This serves to counteract the cooling of the patient being treated.

Citrate can be supplied from a container 211 for citrate solution, for example trisodium citrate solution, to the patient's blood conveyed in the first line 301 by means of a pump 207. This preferably takes place upstream of the blood filter 303.

Calcium can be supplied from a container 213 for calcium solution, for example, calcium chloride solution, to the patient's blood conveyed in the second line 305 by means of a pump 209. This preferably takes place downstream of the blood filter 303.

Blood leaving the blood chamber 303b of the blood filter 303 flows through the optional venous bubble trap 329, which may have a venting device and may be in fluid communication with the pressure sensor PS4.

An addition site 325 for heparin or another anticoagulant may be provided optionally.

To avoid repetition, the description of the control device 150, the computer system 1 according to the invention and the display 160 is referred to in the description of 2 referred to.

The pressure sensors PS1 and PS2 were 2 already pointed out.

In the following, reference is made to the reference symbols and descriptions of the preceding figures where appropriate.

3a shows the output of a prognosis by means of the computer system according to the invention during a normal course of treatment with a functional blood filter 303. 3a shows a diagram as an example of an output of a predicted course Vp of the sodium level (in [mmol/l]) for the patient's blood as an example of a blood parameter (y-axis) over time (in [h]), here over the treatment duration (x-axis). The course could be output in this way or similarly on an output device 505, as described herein.

The predicted course Vp of the sodium level, as it should be found in the patient's blood after modeling, is shown as a dashed-dotted line for better clarity, while the real course Vr of this patient parameter over time is shown by a solid line.

The small deviation between the predicted course Vp and the actual course Vr shows that with the current settings of the treatment device 100, the appropriate setting values for the treatment of the patient were selected, particularly in view of the condition of the blood filter, which is why for the example of 3a the sodium level in the patient's blood is developing in the desired direction. A target value could be in the range of the physiological concentration, for example, 140 units on the y-axis of the figure.

3b shows an exemplary output of the result of a prognosis created a posteriori using the computer system according to the invention to check the usefulness of the computer system retrospectively, i.e. after the treatment of a specific patient, after an initially less than optimal course of treatment of the patient.

3b thus shows in a similar way to that of the 3a analogous diagram another example of an output of a - albeit subsequently created - predicted course Vp of the sodium level in the patient as an example of a blood parameter (y-axis) over time, here over the treatment duration (x-axis).

The predicted Vp course of the patient's sodium level, again shown as a dashed line, initially deviates from the actual Vr course of the patient parameter, again shown as a solid line. This may be because, given the circumstances that are sometimes not always known or understandable for the specific case, a sub-ideal treatment parameter setting was chosen. The actual Vr course of the patient's sodium level had to develop as it did with the selected settings in the given context. This may have reasons that are not attributable to the condition of the blood filter.

After 40 hours of treatment (highlighted by a dotted line), the settings of the treatment parameters or the setting values were adjusted by the responsible physician, which This resulted in the subsequent forecasted course Vp and the actual course Vr changing together after this point in time. The two curves remain relatively close to each other, but their course changes direction. The forecast and the actual course are thus close together, meaning the forecast would have been a good one.

In the example of 3b In some embodiments, the computer system 1 could have communicated or communicated this fact to the medical staff during an interim sample analysis of the patient's blood, possibly as early as four hours later (highlighted by a dotted line), since at this point in time, the actual course Vr and the predicted course Vp with the selected settings of the treatment device 100 had already developed in an undesirable direction.

In the example of 3b a forecast over 72 hours is shown, which, had the computer system 1 already existed in this form, would advantageously not have been over the entire period shown as in 3b shown, since computer system 1 could or would always make and display a changed, i.e. adjusted and current, forecast for the future when changes to the setting values were made in the light of the displayed forecast.

As already explained, after entering the settings for the patient to be treated at time zero, the user of computer system 1 can receive a forecast for the future course of the blood parameter in question for precisely these settings. If the user changes the calcium dosage and thus the settings, for example, after 12 hours, they will receive a new, revised forecast for the future after this time and will then already know how the patient is likely to develop or should develop with the given settings.

3c shows an exemplary structure of a prognosis by means of the computer system 1 according to the invention when a lack of functionality of the blood filter 303 (“clogging”) occurs.

3c shows a diagram as an example of an output of a predicted course Vp for the sodium level of the patient's blood (left y1-axis) as an example of a blood parameter over time, here over the treatment duration (x-axis), as it could be output on an output device 505 as described herein.

The diagram shows that additional blood parameters or patient parameters could be predicted and displayed using computer system 1. In the example of 3c This is the predicted course V _Bi of the bicarbonate level in the patient's blood (right y2 axis). The bicarbonate level is chosen purely as an example and should not be understood as limiting. The display of further or other patient parameters, in particular blood parameters, is also encompassed by the present invention.

The predicted Vp curve of the sodium level in the patient's blood, again shown as a dashed line, differs significantly from the actual Vr curve of this blood parameter, again shown by a solid line. Both curves diverge from each other in a scissor-like manner starting approximately 48 hours later (highlighted by a dotted line), which suggests a "clogging" of blood filter 303, i.e., a reduction in its functionality, starting around this point.

The computer system 1 according to the invention can be further programmed to measure a predicted value or predicted course at one-sided or multi-sided limit values, limit ranges, reference values or reference ranges, to compare them with these and/or to have them displayed or to display them as a function thereof.

4 shows an exemplary sequence of a computer-implemented method according to the invention.

Method step S1 represents the provision of a computer system according to the invention.

In method step S2, the user can now enter input values that they propose for the treatment of the patient in question. Alternatively, the input values can be predetermined, e.g., by a blood treatment device, e.g., its control device, and/or a device of the computer system. The input values include at least setting values, which in turn intended and/or suitable for setting or specifying machine parameters on the blood treatment device for carrying out the patient's treatment session.

A prediction, based on the input of the input values, of at least one value resulting at a point in time during the treatment session, or a course resulting over a period of time during the treatment session, for at least one blood parameter of the patient is represented by method step S3.

Finally, method step S4 represents a transmission of the predicted value or curve, possibly including further information as an aid to interpretation, to an output device for the user's information, for example by means of signal transmission via an output interface.

List of reference symbols

1

computer system

5

Calculating device

100

Blood treatment device

101

blood pump

102

Dialysate drain line

104

Dialysis fluid supply line

105

Substitute line

107

Predilution valve

107a

line belonging to the predilution valve

109

Postdilution valve

109a

line belonging to the post-dilution valve

111

Substitution pump

131

Ultrafiltration pump

150

Control device

153

Drain for effluent

155

water source

157

heat exchanger

159

first river pump

160

Display

161

Device for balancing

162

heating device

163

Mixing device

163a

Conductivity sensor

163b

Conductivity sensor

165a

Temperature sensor

165b

Temperature sensor

166

Concentrate supply

167

Leakage sensor

168

Concentrate supply

169

second flow pump

171

pump; sodium pump

173

pump; bicarbonate pump

175

Compressed air source

200

Container for ready-to-use dialysis fluid

207

Pump for citrate solution

209

Pump for calcium solution

211

Container for citrate solution

213

Container for calcium solution

300

extracorporeal blood circulation

301

first line; arterial line section; blood collection line; arterial patient line

302

arterial patient tube clamp

303

Blood filter or dialyzer

303a

Dialysis fluid chamber

303b

blood chamber

303c

semi-permeable membrane

305

second line; venous line section; blood return line; venous patient line

306

venous patient tube clamp

315

Detector for detecting air bubbles and/or blood

317

Single-needle chamber

318

Ventilation device

319

Detector for detecting air bubbles and/or blood

325

Addition site for anticoagulant, e.g., heparin

329

Venous air separation chamber; venous bubble trap (optional)

400

Effluent bag

500

Input device

501

Input interface

503

Output interface

505

Dispensing device

A

Container for A concentrate; sodium

B

Container for B concentrate; bicarbonate

F1

filter

F2

further filter stage

PS1

arterial pressure sensor (optional)

PS2

arterial pressure sensor (optional)

PS3

Pressure sensor (optional)

PS4

Pressure sensor (optional)

PS5

pressure sensor

V

valves

V24

valve

V25

valve

VB

Bypass valves

VBi

Course of bicarbonate levels in the patient

Vp

predicted course of sodium levels in the patient's blood

VR

actual course of the sodium level in the patient's blood

X

x-axis

Y

Y-connector

y

y-axis

y1

left y1 axis

y2

right y2-axis

ZE

central unit; cloud

Claims (28)

A computer system (1) for assisting a user in preparing, conducting, or simulating an extracorporeal blood treatment session of a patient using a blood treatment device (100), comprising: - a computing device (5), - an input interface (501), - an output interface (503); wherein the input interface (501) is configured to input or read input values, suggested by the user or specified by, for example, a blood treatment device (100), e.g., its control device (150), and/or a device of the computer system, which include: - setting values for setting or specifying machine parameters on the blood treatment device (100) for conducting the patient's treatment session; wherein the computing device (5) is programmed to execute a method to - predict, based on the input values entered, at least one value resulting at a point in time during the treatment session, or a progression resulting over a period of time during the treatment session, for at least one blood parameter of the patient or for at least one test parameter, and to - transmit the predicted value or progression to an output device (505) by means of signal transmission for the user's information by means of the output interface (503). Computer system (1) according to Claim 1 , the setting values comprising: - pumping rates, ultrafiltration volumes, heating rates, sodium and/or bicarbonate concentration in the dialysis fluid, treatment modes, pressures, limits of pressure ranges to be monitored, compositions of solutions used for treatment and/or the like. Computer system (1) according to one of the preceding claims, wherein the input values further comprise: - measured or otherwise collected values of the patient's blood parameter or of the at least one test parameter, collected before the start of the procedure and/or the treatment session. Computer system (1) according to the preceding claim, wherein the blood parameter(s) comprise one or more of the following blood parameters: - sodium concentration or sodium ion concentration - creatine, urea, bicarbonate, potassium, calcium, glucose, chloride, hematocrit - pCO ₂ , pH, HCO ₃ ^- , BE (base excess), pO ₂ , SpO ₂ , SaO 2 (arterial oxygen saturation) Computer system (1) according to one of the two preceding claims, wherein the input values further comprise: - measured or otherwise collected values of the patient's blood parameter or of the at least one test parameter, collected after the start of the procedure or treatment session. Computer system (1) according to one of the preceding claims, further programmed to make a statement about the state of a blood filter (303) used for blood treatment according to predetermined rules based on the predicted value or course of the blood parameter or the at least one test parameter, in particular in comparison with a, preferably after the start of the method ren or the treatment session, measured or otherwise recorded value of the patient's blood parameter or of at least one test parameter. Computer system (1) according to one of the preceding claims, further programmed to predict a state of a blood filter (303) used for the blood treatment for at least one point in time according to predetermined rules based on the predicted value or course of the blood parameter or the at least one test parameter, in particular in comparison with a value of the patient's blood parameter measured or otherwise collected, preferably after the start of the method or treatment session. Computer system (1) according to one of the preceding claims, further programmed to measure the predicted value or profile at limit values or ranges or reference values or ranges, to compare it with these and/or to have it displayed as a function thereof and/or to draw conclusions about possible conditions of the patient and/or the blood filter (303) from deviations from the predicted value or profile and preferably to inform the user thereof. Computer system (1) according to one of the preceding claims, further comprising an output device (505) prepared to receive and output, in particular to indicate, the predicted value or profile of the at least one blood parameter or at least one test parameter in signal connection with the output interface (503). Computer system (1) according to one of the preceding claims, further prepared for proposing at least one change to at least one setting value according to predetermined rules based on the predicted value or profile of the blood parameter or at least one test parameter such that when this setting value is set, the subsequently re-predicted or as described herein predictable value or profile of the at least one blood parameter or at least one test parameter comes to lie between limit values or within limit ranges or between reference values or within reference ranges. Computer system (1) according to one of the preceding claims, further comprising a blood treatment device with a control device prepared for receiving the setting values transmitted by signal transmission. Computer system (1) according to the preceding claim, wherein the control device is programmed to control or regulate the blood treatment device based on the setting values transmitted by signal transmission. Blood treatment device for extracorporeal blood treatment of a patient, comprising or being in signal connection or prepared for signal connection with - a computer system (1) according to one of the Claims 1 until 12 ; - a display (160) for interacting with and/or informing the user; and - a control device (150). Blood treatment device (100) according to the preceding claim, comprising a control device prepared for receiving the setting values transmitted by signal transmission. Blood treatment device (100) according to Claim 13 or 14 for the extracorporeal blood treatment of a patient, designed as a dialysis device, hemodialysis device, hemofiltration device or hemodiafiltration device, in particular as a device for acute, chronic renal replacement therapy or for continuous renal replacement therapy (CKRT). Blood treatment device (100) according to one of the Claims 13 until 15 , wherein the computer system (1) is part of the control device (150) and/or the output device (505) is the display (160). Computer-implemented method for assisting a user in the preparation or implementation of an extracorporeal blood treatment session of a patient or simulation carried out by means of a blood treatment device (100), comprising the steps: - providing a computer system according to one of the Claims 1 until 12 ; - Entering input values, suggested by the user, originating from a storage system with Data of the treated patient or specified by, for example, a blood treatment device (100), for example its control device (150), and/or a device of the computer system, which comprise: - setting values for setting or specifying machine parameters on the blood treatment device (100) for carrying out the patient's treatment session; - predicting, based on the input of the input values, at least one value resulting at a point in time during the treatment session, or a curve resulting over a period of time during the treatment session, for at least one blood parameter of the patient or at least one test parameter, and - transmitting the predicted value or curve by means of signal transmission for information by the user via the output interface (503) to an output device (505). Computer-implemented method according to Claim 17 , the setting values comprising: - pumping rates, ultrafiltration volumes, heating rates, sodium and/or bicarbonate concentration in the dialysis fluid, treatment modes, pressures, limits of pressure ranges to be monitored, compositions of solutions used for treatment and/or the like. Computer-implemented method according to Claim 17 or 18 , wherein the input values further comprise: - measured or otherwise collected values of the patient's blood parameter or at least one test parameter, collected before the start of the procedure and/or the treatment session. Computer-implemented method according to the preceding claim, wherein the blood parameter(s) comprise one or more of the following blood parameters: - sodium concentration or sodium ion concentration - creatine, urea, bicarbonate, potassium, calcium, glucose, chloride, hematocrit - pCO ₂ , pH, HCO ₃ ^- , BE (base excess), pO ₂ , SpO ₂ , SaO 2 (arterial oxygen saturation) A computer-implemented method according to one of the two preceding claims, wherein the input values further comprise: - measured or otherwise collected values of the patient's blood parameter or at least one test parameter collected after the start of the procedure or treatment session and/or - other data characterizing the treated patient. Computer-implemented method according to one of the Claims 17 until 21 , wherein, according to predetermined rules, a statement is made about the condition of a blood filter (303) used for the blood treatment based on the predicted value or progression of the value of the blood parameter or at least one test parameter, in particular in comparison with a value of the patient's blood parameter or at least one test parameter measured or otherwise recorded, preferably after the start of the method or the treatment session. Computer-implemented method according to one of the Claims 17 until 22 , wherein, according to predetermined rules, a state of a blood filter (303) used for the blood treatment is predicted for at least one point in time based on the predicted value or progression of the value of the blood parameter, in particular in comparison with a value of the patient's blood parameter or at least one test parameter measured or otherwise collected, preferably after the start of the method or treatment session. Computer-implemented method according to one of the Claims 17 until 23 , whereby the predicted value or trend is measured against limit values or ranges or reference values or ranges, compared with them and/or presented in dependence thereon. Computer-implemented method according to one of the Claims 17 until 24 , wherein the predicted value or profile of the at least one blood parameter or at least one test parameter is received and output by means of an output device (505) in signal connection with the output interface (503). Computer-implemented method according to one of the Claims 17 until 25 , further comprising proposing at least one change to at least one setting value according to predetermined rules based on the value or progression of the predicted value such that when this setting value is set, the subsequently re-predicted or predictable value or progression as described herein of at least one blood parameter or at least one test parameter lies between limit values or within limit ranges or between reference values or within reference ranges. Computer-implemented method according to one of the Claims 17 until 26 , wherein the computer system is further connected to a blood treatment device comprising a control device to which setting values are transmitted via signal transmission. Computer-implemented method according to the preceding claim, wherein the control device controls or regulates the blood treatment device based on the setting values transmitted by signal transmission.

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