EP3980092A1

EP3980092A1 - Calculation apparatus and dialysis apparatus

Info

Publication number: EP3980092A1
Application number: EP20731814.8A
Authority: EP
Inventors: Andreas Maierhofer
Original assignee: Fresenius Medical Care Deutschland GmbH
Current assignee: Fresenius Medical Care Deutschland GmbH
Priority date: 2019-06-07
Filing date: 2020-06-03
Publication date: 2022-04-13
Also published as: KR20220018979A; CN114080247A; US20220313879A1; DE102019115553A1; WO2020245151A1; JP2022535899A; CA3140734A1; AU2020286932A1; BR112021024436A2; JP7566797B2

Abstract

The invention relates to a calculation apparatus (100) for determining an interdialytic sodium administration (m_inter) of a patient and/or for determining a non-osmotically based interdialytic fluid administration (V_{excess drink}), having a storage apparatus (101) and/or an input apparatus (103) configured for storing and inputting parameter values of the patient; a computing device (105) configured for calculating the interdialytic sodium administration (m_inter) of the patient and/or for calculating their non-osmotically based interdialytic fluid administration (V_{excess drink}); and an output apparatus (107) for outputting a signal for open-loop or closed-loop control of a communication apparatus (109) and/or a medical blood treatment apparatus (4).

Description

description

Calculation device and dialysis device

The present invention relates to a

Calculation device according to the preamble of claim 1 and a medical blood treatment device according to the preamble of claim 10 and a method.

Numerous studies show that an increased

Saline intake in the general population leads to an increased incidence of cardiovascular diseases, and cardiavascular events such as heart attack and stroke could be reduced by reducing the intake of table salt (NaCl). In particular, an increased consumption of table salt leads to increased blood pressure in part of the population. Recent studies also leave a negative one

Suspect an influence on the immune system (Afar et al., Salt Intake and Immunity, Hypertension 72 p. 19ff; Evans et al., Emerging evidence of an effect of salt on innate and adaptive immunity, NDT, published online 2018, December 5).

People with impaired kidney function depend on the fact that excess sodium is removed from them by means of dialysis. It is therefore particularly relevant for them to know the amount of salt they have consumed. Nutritional advice and following the rules learned can be helpful here.

Nutritional advice currently takes place mainly on the basis of nutritional tables. With regard to the salt content, there are tables with the typical salt content of Food. In the case of ready-made foods, there is also information relating to the overall product, typical portions or per

Weight unit. At the same time, they actually have to

consumed products and quantities for a calculation

be determined. In practice, the determination regularly turns out to be uncomfortable.

It is an object of the present invention to provide a

Calculator for sodium intake at

Dialysis patients and another medical one

To propose blood treatment device.

The object of the invention is achieved by a

Computing device with the features of claim 1 solved. It is also achieved by means of the medical blood treatment device having the features of claim 8.

According to the invention, a calculation device is therefore proposed. The calculation device is configured to determine an interdialytic (ie between two consecutive dialysis sessions, in particular since the last or the previous dialysis session (also short: dialyses)) and / or daily

Sodium intake (also referred to herein as _middle ) one

Patients (also: dialysis patients, albeit mostly briefly referred to as patients). As an alternative or in addition to this, the calculation device is configured to determine an interdialytic drinking amount, in particular an interdialytic drinking amount or fluid supply that is not osmotically based (also referred to herein as V _exC ess drink). For this purpose, the calculation device has a

Storage device and / or an input device, further a computing device and an output device.

The storage device is configured to store parameters (or parameter characteristics or values) of the patient. The input device is configured to input parameter values of the patient.

The computing device is configured and / or programmed to calculate the interdialytic data

_Sodium intake _with the dialysis patient and / or to the

Calculate the interdialytic hydration V _{excess drink} .

The calculation can be based on stored formulas or

Support algorithms such as disclosed herein. The

As an alternative or in addition, the calculation can be based on the parameter values that can be called up by the computing device from the storage device or the input device.

The output device can be configured to output a signal for controlling a communication device and / or for controlling or regulating a medical one

Blood treatment device.

The communication device can be designed as a display device, monitor, display, printer, database, etc. or contain one.

The communication device can optionally be part of the

Computing device or medical Be blood treatment device or herewith in each case

be connected.

According to the invention there is also a medical

Blood treatment device (short: treatment device) proposed.

The blood treatment device according to the invention has:

Fluid lines, which at least one

Dialysis fluid supply line and / or a dialysate drain line, which are optionally connected to one another in fluid connection, for example by means of a connector; at least one delivery device for delivering a dialysis fluid within the

Dialysis fluid supply line and / or the dialysate drain line; and at least one control and / or

Control device.

The medical blood treatment device is configured to use a dialysis fluid supply line and a dialysate drain line each with a

To be connected to the dialysis fluid chamber of a blood filter which, in addition to the dialysis fluid chamber, has a blood chamber, the dialysis fluid chamber and the blood chamber being separated from one another by a semipermeable membrane. The control and / or regulating device is configured, a blood treatment by means of the medical blood treatment device by means of hemofiltration,

Initiate or effect hemodialysis or hemodiafiltration. The control and / or regulating device is provided with a calculation device according to the invention in FIG

Signal transmission connected or has such.

In all of the above and all of the following statements, the use of the expression “can be” or “may have” etc. is to be understood as synonymous with “is preferably” or “preferably” etc. and is intended to explain an embodiment according to the invention.

Whenever numerical words are mentioned here, the person skilled in the art understands them to indicate a numerically lower limit. Unless this is not recognizable to the expert

If there is a contradiction, the person skilled in the art therefore always reads “at least one” or “at least one” when indicating “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 technically possible for the person skilled in the art. Both are from the

present invention includes and applies to all numerical words used herein.

When "programmed" or "configured" is mentioned herein, it is also disclosed that these terms can be exchanged for one another or for "software-programmed". Whenever a suitability or a method step is mentioned herein, the present invention also includes a corresponding programming or configuration of a suitable device or a section thereof - e.g. B. the blood treatment device - as well as devices programmed in this way.

Advantageous further developments of the present invention are each the subject of subclaims and

Embodiments.

If an embodiment is mentioned here, this represents an exemplary embodiment according to the invention.

Embodiments according to the invention can have one or more of the features mentioned above and / or below in any technically possible combination.

When it is mentioned herein that a value is calculated on the basis of a parameter value (or another variable), it can be included here that the calculation is based on an estimate of the parameter value or an approximation of the

Parameter value (or to the other size) is calculated.

In some embodiments, the computing device is configured and / or programmed (both terms are interchangeable herein) to perform interdialytic

_Sodium intake _with and / or interdialytic

Fluid intake V _exC ess drink based on that prevailing at the beginning of the dialysis session n Plasma sodium concentration c _pr e (n) and / or der

To calculate concentration of sodium in the urine _U c rine.

In some embodiments, the sodium intake was interdialytisch mi _nter and / or the liquid supply interdialytic V _exC ess drink using one of the mentioned herein formulas 1 3 5 8 11 12 13 14 are,,,,,,, calculated 17th

When the interdialytic fluid supply or the fluid supply V _exC ess drink is mentioned here, this can be understood to mean a volume of fluid that is to be calculated here (and preferably removed by dialysis). It can be a

Act as the volume of fluid that the patient has consumed without this being necessary to maintain fluid balance. Therefore, it is optionally referred to herein as the liquid supply V _exC ess drink.

In some embodiments, the computing device is in signal communication, directly or indirectly, with components of the medical blood treatment device. The

Signal communication is provided in this way or

configured that multiple values which run off during a by means of the blood treatment device

Dialysis session from the medical

Blood treatment device are measured, such as. B. the plasma sodium or an intradialytic salt transfer, e.g. B. by means of the input device or by means of

Communication device to the computing device

be transmitted. This can be done by querying these values from the medical blood treatment device. It but can also take place by means of a transmission function that originates from the medical blood treatment device. Based on these values, the calculation of the

Interdialytic sodium supply and / or the interdialytic liquid supply can be carried out or repeated several times during the ongoing dialysis session. Since later measured values are regularly more precise than those obtained at an earlier point in time, this procedure can be too

lead to more precise calculation results for sodium intake and / or fluid intake.

In some embodiments, the output device is capable of outputting a signal for controlling a

Communication device is configured, further

configured to values for the interdialytic sodium intake and / or the interdialytic

Fluid supply on a display device as

Display, output and / or store communication device, which is a monitor, a display, a printer, a storage element or a database or the like.

In some embodiments, the output device is used to output the signal for controlling a

Communication device is configured, further

configured to provide a prescription based on interdialytic sodium intake and / or non-osmotic interdialytic hydration. The prescription can relate to the ongoing or a pending dialysis session. She can do one

Influence on the adjustable on the machine side

Be treatment parameters. In some embodiments, the output device is configured to use the signals output by it to the medical blood treatment device to transmit the

to control medical blood treatment device in such a way that the current dialysis session or the treatment of the blood ends when or after the determined, interdialytic sodium supply and / or interdialytic fluid supply is withdrawn from the treated blood.

In some embodiments, the calculation device or any of its components, devices or devices is configured to read in values of at least one or more of the following parameters in any combination. B. from the

Input device and / or the storage device can be done:

V volume of distribution of the patient, i.e. H. the

Water content of the patient without overhydration or after removing his overhydration by means of

Dialysis. This parameter can e.g. B. from anthropometric formulas (z. B. the Watson formula) or by means of bioimpedance measurements;

ÄF interdialytic excess fluid;

mostly corresponds to the interdialytic weight gain. Dehydration V _UF = AF is often prescribed for the dialysis session; Plasma sodium concentration at the beginning of the current

Dialysis session (dialysis session n); she is z. B. determined from laboratory measurements or from conductivity-based online determination using OCM (Online Clearance Monitoring) (cf. EP 3 183 013 A1 or WO 2016/026569 A1 cited therein); Plasma sodium concentration at the end of the

previous dialysis session (referred to as dialysis session n-1); she can z. B. can be determined from laboratory measurements or from conductivity-based online determination, e.g. B. by means of OCM. This value is preferably at the end of the previous one

Dialysis session n-1 patient-related stored on a suitable storage medium such as the storage device mentioned herein and in the

current dialysis session made available again;

Imrine accumulated residual excretion between the

considered dialysis sessions n and n-1. This value can be determined by the patient at home (keyword: urine collection). In the case of constant habits, a representative value can be stored for the patient, advantageously as a daily amount (alternatively as a volume), so that this can be used for different lengths of time

interdialytic intervals the total amount can be calculated; curtn @ sodium concentration in urine, e.g. B. out

Laboratory measurements or as an assumption

Plausibility considerations determined. In particular, this value and its possible errors in Dependence on Kr a can be estimated: Since the dialysis patient has severe renal insufficiency, the upper limit for this value can be be accepted. The lower limit can e.g. B. the possible dilution capacity of the kidney in this state can be assumed, e.g. B. ^c pre, mm = SO mmol /! .

NA Number of days between the end of the last

Dialysis session n-1 and current dialysis session n, determined from the current date and the saved date of the previous one

Dialysis session.

If dialysis fluid is mentioned here, then in case of doubt this refers to the fresh, the

Dialysis fluid chamber of the blood filter over the

Dialysis fluid supply line fluid supplied on the machine side. If dialysate is mentioned here, then in case of doubt this refers to the consumed from the

Dialysis fluid chamber of the blood filter on the machine side via the dialysate drain line.

In some embodiments, the

Communication device output signals together with the indication of the qualitative and / or quantitative accuracy of the signal or a means of signal

transmitted value, the size of an error, a

(Z. B. a confidence interval) uncertainty of a possible range of values, etc. of signal or value, in particular the sodium intake interdialytisch carried rni _nter and / or the liquid supply interdialytischen V _exC ess drink or these concerning, transmitted. It is also possible to specify a standard deviation, variance, a color coding with optionally several colors, a traffic light display, etc. This can help to better understand an associated, displayed value.

In some embodiments, the qualitative and / or quantitative accuracy of the value can thus be determined by numerical specification of an error (e.g. standard deviation) or a possible range of values (e.g. confidence interval) or by a different type of characterization of the reliability of the value, e.g. B. in color according to a traffic light model, be or will be communicated.

In some embodiments, the qualitative and / or quantitative accuracy may be or include the size of an error, an uncertainty and / or an imprecision.

In some embodiments it can be configured to input some or all of the parameter values either directly on the medical blood treatment device or to have them input by the dialysis machine from external sources (storage medium, network, etc.). It is also possible that the

Calculation z. B. the interdialytic, daily and

mean daily salt intake and / or the

The amount of liquid on external devices is carried out and the measured values of the medical

Blood treatment device are continuously transmitted to the external device.

A "dialysis session" can, for example, be a

Treatment unit using hemodialysis, hemofiltration, Hemodiafiltration and / or a cell separation process and for the treatment and / or purification of blood. A suitable blood treatment device is used to carry out such a blood treatment.

During hemodialysis, the concentration of small-molecule substances between blood and blood is balanced

Dialysis fluid over a semipermeable membrane, which the blood side and the hydraulic side of the

Blood treatment device separates from each other. In this way, mainly toxins and other substances that are responsible for the kidneys are removed from the blood to be purified

Dialysis fluid are included.

The blood treatment device is in some

Embodiments prepared to reduce the sodium content of the

Dialysis fluid, controlled by the control or regulation device, to vary.

Sensors can be provided to determine the

temperature compensated conductivity and des

Fluid flow upstream and downstream of the blood filter.

These can be used to determine the temperature compensated

Conductivity be designed for ion-selective measurement, or for measurement according to other methods.

Based on the sensor values obtained, the control or regulation device in some embodiments carries out mathematical calculations to determine the electrolyte and liquid balance. It can also use user specifications and stored algorithms to determine the default value for the electrolyte and electrolyte to be achieved in the current treatment

Determine fluid balance. User specifications and the Calculated values or the progress of treatment can be displayed, for example, via a user interface.

For a possible calculation of minter or V _exC ess drink, the following considerations and formulas made elsewhere can be used as examples:

If a patient is described in the so-called single pool model by a distribution volume V (preferably normohydrated, i.e. without overhydration) with the sodium concentration c, the following applies to the sodium balance between two dialysis sessions):

Here (n) means the status at the current one

Dialysis session and (n-1) those of the immediate

preceding, the indices "pre" and "post" give the

Point in time, namely at the beginning or at the end of

Dialysis session. The index "urine" denotes values in the urine, with the index "j" here all urine collections in the

called interdialytic interval. If there is no more residual diuresis, ^ urine, / ⁼ ^.

The distribution volumes and ^ vo can e.g. B. out

Bioimpedance measurements are determined. However, it can be more practicable and optionally more precise to determine only one of these values directly and add e.g. B. to assume that the

Volume difference AV versus V of the interdialytic

Weight gain, which can be determined by weighing the patient after and before the dialysis session:

The irtter corresponds to the interdialytic sodium intake. The interdialytic salt intake of the patient can be determined by laboratory measurements of the blood sodium concentration before and after the dialysis session as well as by collecting the urine between the considered dialysis sessions n and n-1 and laboratory measurements of the sodium concentration in the collected urine from the interdialytic interval without an analysis the diet is necessary.

However, since frequent blood analyzes are not practicable in everyday clinical practice, an automated and / or

Calculating the salt balance is extremely advantageous.

It is assumed that the interdialytic

Volume increase completely through the interdialytic

Dehydration VUF by means of ultrafiltration in the

subsequent treatment is compensated.

With the _dehydration, sodium is withdrawn m _Wf at the same time _;

Here, ^c do represents the sodium concentration downstream of the dialyzer. This can be determined from the temperature-compensated conductivity CD measured in the outflowing dialysate using a kinetic model for the influence of the concentration of electrolytes other than sodium, such as e.g. B. Potassium (CK) and

Bicarbonate ( ^C BIC), can be determined (see EP 2 413 991 Bl) In the absence of residual kidney excretion, miip corresponds to interdialytic sodium uptake if the plasma sodium concentration does not change as a result of the dialysis (i.e. in isonatremic dialysis), ie if there is no salt transfer between the blood and the blood during the dialysis session

Dialysate takes place. This is the case when the blood and dialysate sodium concentrations differ only slightly. In this case:

Otherwise, the change in the plasma sodium concentration due to diffusive transfer ^ra difl between dialysate and blood during the dialysis session can be taken into account:

This then generally applies: The calculation of ^m dtff on the dialysate side by continuously measuring the temperature-compensated conductivity upstream and downstream of the dialyzer or blood filter with correction using a kinetic model is also in

EP 2 413 991 B1 discloses.

If the predialytic plasma sodium concentration corresponds to a physiologically normal state, it is

advantageous to adapt the dialysis fluid sodium concentration so that ^m d = 0. This condition is reached when the salt intake is compensated for by drinking an appropriate amount of water in the interdialytic interval so that the plasma sodium concentration does not change. If this is not the case, e.g. B. because the patient drinks more than at the time for reasons that are not related to the feeling of thirst

Compensation of the salt intake is necessary and thus the amount of liquid that is not osmotically justified is consumed, so the resulting amount represents

Plasma sodium concentration is a pathological condition. Diffusive salt transfer during the dialysis session, i. H . HhüfF ^ ß, this condition can be compensated again. This can be described in the physiological concept of "free water removal": If the kidney is functioning, a positive free water clearance means that the

Sodium concentration in the urine is lower than in the plasma, ie the kidneys hold back sodium and thus increase the plasma sodium concentration. On the other hand, if the free water clearance is negative, the sodium concentration in the urine is higher than that in the plasma, ie the kidneys excrete sodium and thus lower the plasma sodium concentration. This can be applied to the during the

Transfer relevant parameters to the dialysis session:

The "free water removal" y ^ ws denotes that

(virtual) volume of salt-free water, which the

Withdrawn patient who has a volume of distribution V

(V _VWR > 0) or supplied (ypwR <0) to its

Change plasma sodium concentration from ^c ure to OBI. This change corresponds to the change in

Plasma sodium concentration due to the diffusive salt transfer during the dialysis session:

Algebraic transformation according to ^ FWE gives:

Similarly, the drinking volume ^ _{ΪOBEB drinf} e can be determined in the interdialytic interval (i.e. the time between two consecutive dialysis sessions n-1 and n), which has led to a change in the plasma sodium concentration, and which the patient in the interdialytic interval, so to speak, “via thirst "drank

This additional fluid uptake then led to a shift in his "physiological" plasma sodium level towards a pathological state.

By removing ^ pwi = ^ eicessdririk z. B. by increasing the plasma sodium concentration through dialysis, this drinking volume is balanced again.

In the presence of residual diuresis, the amount of salt ingested with food is greater than that during

Dialysis session certain amount. To determine the amount of salt excreted in the urine, z. B. the

Gurine sodium concentration needed. This can e.g. B. by laboratory measurements of urine collection under typical conditions.

With falling residual excretion the ability of the kidneys to concentrate the sodium concentration was increasingly disappearing, then the sodium concentration in the urine that ^c urine increasing the plasma sodium concentration ^c ure approaches. An estimate can therefore also be made under these conditions:

To better understand the daily eating and drinking

Drinking habits, it is advantageous to refer to daily quantities V ^' FWR and ^m inter by dividing these sizes by the Number of AD of days to be divided in the interdialytic interval:

With the predominant dialysis regimen of three dialysis sessions per week, the interdialytic interval is over

Weekend a day longer than the other two

Intervals, so that in this interval the accumulation of fluid and salt in the patient is increased compared to the two other intervals. However, since the dialysis session typically lasts the same length on all three treatment days, in clinical practice, in order to improve the tolerability of the dialysis, it regularly happens that the treatment does not include the entire treatment after the long interval

Overhydration is withdrawn again, but this only takes place gradually in the two remaining dialysis sessions of the week. In these cases it is beneficial to go through

__ ^y pws

Storage of ^ er and ^PWK ' ^d »a and by averaging the values over all values z. B. one week to calculate the respective values, where N is the number of dialysis treatments and

Nw represent the number of days in the averaging period:

In particular with a view to the display of what has been calculated according to the invention, the following ideas can be used in the context of the present invention: So you can calculate and / or display the

interdialytic, daily and weekly salt intake or amount of fluid some or some of the following and e.g. T. parameters already mentioned above are taken into account:

• F: volume of distribution; H. Patient's water content after removal of the overhydration. This can be from

anthropometric formulas (e.g. Watson's formula) or by means of bioimpedance measurements;

• AF: interdialytic excess fluid corresponding to the interdialytic weight gain. Often used for the

Dialysis prescribed _dehydration V _UF = AV;

• N _ä : Number of days between the end of the last dialysis and the current dialysis, determined from the current date and the saved date of the previous dialysis; Plasma sodium concentration at the start of dialysis,

determined from laboratory measurements or from

Conductivity-based online determination using OCM (cf. EP 3 183 013 Al or

WO 2016/026569 A1); - 1): plasma sodium concentration at the end of the

previous dialysis, determined from laboratory measurements or from conductivity-based online determination using OCM. At the end of the previous dialysis, this value is stored patient-related on a suitable storage medium and is used again for the current dialysis

Provided; • t _mrine ¹ cumulative residual excretion between dialyses. Determined by the patient at home. With constant habits, a representative value for the

Patients are deposited, advantageously as a daily amount, so that from this for different lengths

interdialytic intervals the total amount can be calculated;

• ^c _rine ^: sodium concentration in urine, from laboratory measurements

or as an assumption based on plausibility considerations.

In particular, the value and its possible error in

Dependency on 1 _{ri e can be} estimated: Since at

Dialysis patients with severe renal insufficiency can be assumed as the upper limit c _pre (n). As

Lower limit can be the possible in this state

Ability of the kidney to be diluted, e.g. B.

C _pre ,. ™ = SO mmol / l.

All parameters mentioned herein or their values can be checked either directly on the dialysis machine or medical

Blood treatment device entered or from

Dialysis machine can be read from external sources (storage medium, network, etc.). It is also possible that the

Calculation of the interdialytic, daily and mean daily salt intake is carried out on external devices and the medical values required for the calculation

Blood treatment device are continuously transmitted to the external device.

One aspect of the representation on the display device of the medical blood treatment device or on a external medium is that an estimate of the parameter of interest is presented as soon as possible. If further data are available during the dialysis session, e.g. B. from determinations of the plasma sodium concentration or des

intradialytic salt transfers, this estimated value is refined so that at the end of dialysis the value is available with the highest possible accuracy. The actual

The accuracy of the value can be determined by numerically specifying an error (such as standard deviation) or a possible

Value range (e.g. confidence interval) or by another type of identification of the reliability of the value, e.g. B. colored according to a traffic light model.

The calculation of the interdialytic and / or daily

In some embodiments, salt intake is initially carried out separately for the portion of the residual _diuresis . Are F _Hrine and

_{Car «} ™ both known, then m _urine = calculated directly.

If only F _{mrinfl is} known, the maximum salt excretion via the urine is calculated, for example, based on the plasma sodium:

An estimate for can be calculated by for a value typical for dialysis patients, e.g. B. 138 mmol / 1, or a value from laboratory measurements or calculations from previous treatments is used. A lower limit m _{Hrine, Hiin is also} calculated. This can be a fixed proportion of or a function of the residual excretion V _{vri ne} and c _pre (»), in particular a linear function assuming a maximum dilution c _{UTi TB iniTi} with a residual diuresis that has a maximum value _urineRia3S

exceeds and assuming that decreases with decreasing

Residual diuresis e _arinfi c _pre («) approximates. For V _mriIiS <V _{uriR & maji} it is then assumed: For ^assumed illurnienin ^ ^ urine irinenii _*

The one to be removed by dialysis or that has already been removed

Share of interdialyti see salt intake = 0) can also initially be estimated in different ways and then specified with increasing accuracy in the course of the treatment:

• Only F _{up given} as a prescription: where c _{pre; est} an estimated

typical value of the predialytic plasma sodium, e.g. B.

138 mmol / l, or a value derived from previous treatments;

• In addition c _poBt (n— 1) known: estimate z. B. by means of

Formula 1 with estimated value for c _pre ; • If in the course of treatment c _VFe out

conductivity-based measurements have been determined, this value can replace the previously used estimate;

• In the further course, the actual salt withdrawal according to formula 4 and formula 5 or formula 8 for the

Calculation can be used. This calculation will

preferably after reaching the prescribed

Ultrafiltration amount used. In the meantime, the initially estimated value can be continuously corrected by the current measured value, the measured value being the ratio of the currently reached

Ultrafiltration amount to the prescribed

The amount of ultrafiltration can be weighted:

From the proportions calculated in this way for the residual diuresis and the amount removed by dialysis, the calculation and display of the total amount m _inter , based on the interdialytic, daily or average daily salt intake, can then take place in some embodiments.

To display the interdialytic "free water removal" and the interdialytic excess drinking quantity

for example according to formula 10, with multiple or

continuous determination of m _j m (e.g. as in

EP 2 413 991 B1, the content of which is here also made the subject of this disclosure in full by reference is), repeatedly or continuously the current "free water removal" V _{¥ W} can be calculated and displayed during the dialysis session.

For c _pre , before a value determined during the treatment according to a known method (such a method is e.g. in EP 3 183 013 A1 (published as

WO 2016/026569 A1), the content here

is also made the subject of this disclosure in full by reference) is present, initially a

population-related estimate (e.g. 138 mmol / 1), a patient-related historical value, or a laboratory value can be used.

Alternatively, V _{exceEE drir] l £} = V _{¥ vm can} also be calculated according to formula 11 by adding the at the end of the previous dialysis

automatically determined value of the plasma sodium c _poBt (n - 1) is read from an internal or external storage medium.

The display of F _PWK based on estimated values can in turn be marked optically. After one

The intradialytic measured value for c _pre is then used for the further calculation, at least in the current dialysis session.

To support nutritional _advice, l _{xce, EEdrink} = V _FWK can also be _specified during the treatment, but in any case at the end of the treatment, if on

Dialysis machine a prescription of salt transfer

was made. This prescription can also be through Prescribe a relative change in plasma sodium & c according to m _diff = VAc.

In addition to V _PWR , V _FWRd and V _{F Eed} can also be displayed.

Here, display and calculation can be done using the

Calculation device take place both directly and as part of the medical blood treatment device.

In some embodiments according to the invention, the

Knowledge of the interdialytic salt intake m _inte.T and / or the free water removal F _{PWK used} as dialysis prescription. A suitable and optionally provided method is described below:

The z. B. by means of the display device to inform all parties involved values displayed _inter and _{bcobEE3Gϊpΐi} represent the salt intake and the water intake, which lead to a

(pathological) changes in the plasma sodium.

With the aim of making it easier to implement

Prescription dialysis it is now possible to use these values directly to prescribe therapy. Such a one

Prescription then optionally replaces the previous one

Prescription of ultrafiltration quantities and / or

Dialysis fluid sodium concentrations. In particular, according to formula 6, from m _jnter ff _mriine = 0) the

Ultrafiltration amount l _{up will} be calculated as soon as c _pre

has been determined or estimated.

Likewise, from the prescription of a "free water removal"

V _p the corresponding diffusive salt transfer m _diff according to formula 10 was calculated. A control algorithm, e.g. B. as in o. G. EP 2 413 991 B1 described, can then

Adjust the dialysis fluid sodium during the treatment in such a way that nt _{jiH is reached} in the course of the treatment, preferably at the end.

For purely exemplary application examples, reference is also made to the attached figures and / or their description.

The present invention further relates to a method for determining the interdialytic sodium supply of a patient and / or for determining the, in particular not osmotically based, interdialytic fluid supply, the method comprising: calculating the

Interdialytic sodium supply of the patient and / or the calculation of an interdialytic fluid supply of the patient - in particular non-osmotically based

Patients; and optionally outputting a signal to the

Controlling or regulating a communication device and / or a medical blood treatment device.

In some embodiments, the method includes

Calculate the interdialytic sodium intake of the dialysis patient and / or his interdialytic

Fluid intake based on the beginning of the Dialysis session (s) prevailing plasma sodium concentration and / or the sodium concentration in the urine.

In some embodiments, the method includes multiple polling (during one using the

Blood treatment device running dialysis session (s) measured by the medical blood treatment device

Values) e.g. B. by medical

Blood treatment device in order to use the

interdialytic sodium intake and / or the

Repeated or interdialytic hydration

to calculate precisely.

In some embodiments, the method includes

Provide a prescription based on interdialytic sodium intake and / or interdialytic

Hydration.

In some embodiments, the method comprises one or more of the method steps mentioned herein or steps carried out in any combination by means of one of the devices mentioned herein, in particular when they are used as intended or according to their suitability or configuration.

By means of some embodiments according to the invention, one or more of the advantages mentioned herein can be achieved, which include the following:

As stated in the introduction and proven by numerous studies, an increased salt intake can lead to a

increased incidence of cardiovascular disease and favor cardiovascular incidents such as heart attack and stroke.

The table salt ingested with food is used in the

Most of the normal population excreted in the urine, whereby the kidneys have the ability to regulate the salt content in the urine in such a way that both an excess and a relative deficiency of sodium in the blood can be compensated for.

These harmful effects associated with salt intake

Mechanisms are also relevant for patients with missing or severely impaired kidney function. As with these

Patients only excretion of salt with the urine

is limited or no longer possible, an increased salt intake also leads to an increased amount of drinking due to the resulting feeling of thirst, which leads to overhydration of the patient. This leads to a load on the circulation and manifests itself e.g. B. in edema and water retention in the lungs. This overhydration is avoided in patients with kidney failure as part of hemodialysis, which is typically performed several times a week, by means of dehydration

Ultrafiltration degraded again. The higher the amount of fluid to be withdrawn, the higher the withdrawal rate has to be because of the usually fixed dialysis time. However, the higher the withdrawal rate, the higher the risk of

intradialytic (i.e. during dialysis or

Dialysis session) blood pressure drops, which also lead to

Cause long-term damage. Table salt is contained in many foods, especially hidden in ready-made products, where it is used as a cheap seasoning. The salt content of some ready-made pizzas already corresponds to the daily recommended by the WHO

Salt absorption of approx. 5 g NaCl. Despite information on many

Foods with their salt content, these are often ignored and only personal re-salting as salt intake

perceived. So it happens that many dialysis patients, despite regularly prescribed high amounts of ultrafiltration, are not aware that the cause is ultimately in the

(hidden) absorption of salt in the interdialytic

Interval.

It is therefore the task of the treating dialysis doctor and his / her nursing staff, in these cases by a

Nutritional advice on reducing the intake

Amount of salt to act. However, as described, the latter is often not fully consciously perceived, making it difficult to argue with the patient.

For the success of nutritional advice, it is essential to provide the best possible estimate of the interdialytic and daily salt intake. The present invention can be of valuable assistance in this regard. It is also particularly suitable to be used by the patient himself to obtain information about his food intake and in particular his salt or water intake if professional advice is not available. The invention can also be as good as possible for the patient

Estimated physiologically unnecessary and potential

give harmful amount of drink. In addition to drinking, which is triggered by the feeling of thirst caused by salt intake, referred to herein as osmotically controlled drinking, some patients also drink for other reasons

(Habit, "social drinking", etc.). In addition to increasing overhydration, this also leads to a decrease in the

Plasma sodium concentration, which is a pathological condition. Also for recognizing that there is a large amount of fluid

be consumed beyond what can be osmotically justified due to the salt intake, the present invention can advantageously contribute.

The present invention can advantageously be of z. B. the idea of a manual calculation based on the assumption that the prescribed fluid withdrawal corresponds to the interdialytic weight gain and no other way interdialytic salt was excreted again. Are in such a procedure z. B. that occurred during an ultrafiltration treatment

Dehydration with a typical concentration of sodium in the blood, e.g. B. 138 mmol / 1, multiplied in order to estimate the amount of sodium removed from this, this would, however, neither patient-specific deviations of the

Also take into account possible excretions via residual kidney function. The present invention can offer advantages in terms of this as described above.

Thus, by means of the present invention, the interdialytic and daily (dietary) sodium intake as well as the non-osmotic drinking quantity can advantageously be calculated and displayed, even in patients with residual diuresis. In particular, it can be possible by means of the present invention:

• The calculation and display of interdialytic salt and / or fluid intake, the latter referring to deviations from the "ideal", i.e. the

Leave the plasma sodium concentration unchanged,

Drinking amount refers;

• The consideration of the residual diuresis, determined from

external data, when calculating;

• The relation of these quantities to daily or averaged

daily sizes, for this purpose storage of and access to values of previous treatments;

• To offer a display of these values as early as possible during dialysis, for which at first estimated values are used, which then gradually increase as

Information gain through calculations based on

Measured values are replaced;

• The possibility of calculation and display both on the medical blood treatment device and on an external computing and display unit that can also be used on an outpatient basis.

In the following, the present invention is based on

preferred embodiments of the same with reference to the attached drawings. In the figures: Fig. 1 shows schematically simplified sections of a medical device according to the invention

Blood treatment device in an exemplary embodiment, exemplarily connected to a blood cassette for carrying out a

Patient treatment, controlled and / or regulated by a control device, which in

Signal communication is connected to a computing device according to the invention;

Fig. 2 shows a user interface as part of a

computing device according to the invention; and

Fig. 3 shows an exemplary embodiment according to the invention

Computing device.

Fig. 1 shows an extracorporeal blood circuit 1, which can be used for treatment by means of a double-needle access, or using, e.g. B. an additional Y-connector, by means of single-needle access, with the vascular system of the not

presented patient would be connected. The

Blood circuit 1 is optionally available in sections thereof in or on a blood cassette 2. This blood cassette 2 is designed to also be used in other types of treatment,

for example, a single needle treatment to find use.

Pumps, actuators and / or valves in the area of the

Blood circuit 1 are equipped with an inventive

Blood treatment device 4 or connected to a control device 29 comprised by this. The blood circuit 1 has an arterial

Patient hose clamp 6 and an arterial

Connection needle 5 (as an example of an access device) of an arterial section or an arterial

Patient line or blood collection line 9 on. The

Blood circuit 1 also has a venous

Patient hose clamp 7 and a venous connection needle 27 (as an example of a further or second access device) of a venous section or a venous patient line or blood return line 23.

A blood pump 11 is provided in the arterial section 9, and a substituate pump 17 is connected to a substituate line 17a. The substituate line 17a can be connected to a substituate source by means of a, preferably automatic, substituate port 18. Using the

The substituate pump 17 can supply substituate by pre-dilution or by post-dilution via associated lines 13 or 14 in

Line sections, for example in the arterial

Section 9 or into a venous section 23a (between a blood chamber 19a of a blood filter 19 and a venous air separation chamber 21) of the blood circuit 1.

The blood filter 19 has the blood chamber 19a connected to the arterial section 9 and to the venous section 23. A dialysis fluid chamber 19b of the blood filter 19 is provided with a dialysis fluid supply line 31a leading to the dialysis fluid chamber 19b and one leading away from the dialysis fluid chamber 19b

Dialysate drain line 31b connected. The dialysis fluid supply line 31a optionally has a valve V24, by means of which the flow within the

Dialysis fluid supply line 31a can be prevented. The dialysate drain line 31b optionally has a

Valve V25, by means of which the flow within the

Dialysate discharge line 31b can be prevented.

The dialysis fluid supply line 31a is also

optionally connected to a compressed air source 26 by means of a further, machine-internal valve. The

Compressed air source 26 can be part of the

Blood treatment device 4 or be separate therefrom. Downstream of the compressed air source 26 can be a

Pressure sensor 37 may be provided.

By means of an optional

Connection portion 24 can be a venous connection with z. B. the venous section 23 or 23a can be achieved.

The control device 29 can be part of a control device of the blood treatment device 4 or embody the same. The arrangement of FIG. 1 comprises an optional detector 15 for detecting air and / or blood. The arrangement of FIG. 1 further comprises one or two pressure sensors 33a, 33b at the locations shown in FIG. 1. Further pressure sensors can be provided, e.g. B. the pressure sensor 37.

The single-needle chamber 36 is used in FIG. 1 as a buffer and / or compensation container in a single-needle method in which the patient is connected to the extracorporeal blood line 9, 23 by means of only one of the two blood lines

Blood circuit 1 is connected. The arrangement of FIG. 1 also includes an optional detector 25 for detecting substituate and / or blood.

The calculation device 100 according to the invention is shown in FIG. 1 by way of example in signal communication with the control and / or regulating device 29.

The present invention is not limited to that herein

Embodiments described are limited, these are for illustrative purposes only.

2 shows an exemplary user interface as an example of an input device 103 and / or display device 109 for a calculation device 100 according to the invention

Display and prescribe the salt and

Fluid balance.

Such a user interface can be accessed directly on the

Hemodialysis machine and / or to an external with the

Dialysis machine connected display and computing unit

(Computer, laptop, tablet device, ...). By doing

For example, the display and input elements are arranged in rows according to their function, with other arrangements,

Labels, etc. are possible. Not all elements have to be present, or further data can be displayed. This can either be further

Dialysis parameters, or the conversion of values of the displayed displays into other units.

Line 1 contains input elements for prescribing a

Hemodialysis treatment (includes HD and all types of HDF and HF): • V (UF) in field F 1 of FIG. 2: Prescription of dehydration by means of ultrafiltration. The volume set here by the doctor will therefore be withdrawn from the patient until the end of the treatment.

• Target plasma sodium change (field F 2), target diffusive sodium removal (field F 3), target free water removal (field F 4): These three input elements can alternatively

can be used because the parameters contained herein are closely related to one another: As described in the formulas, with additional knowledge of V (urea) and plasma sodium (pre)

convert into each other. It is also possible to select the displayed physical unit within the elements with the aid of internally stored conversion factors (e.g. conversion of “mmol NaCl” into “g NaCl”). Negative values for diffusive Na removal mean one

Sodium transfer into the patient, corresponding to a positive "free water removal"

Line 2 includes input elements for entering auxiliary variables that are required to convert the prescription from line 1 into specific settings of dialysis parameters, in particular the dialysis fluid sodium concentration, or to be able to determine the physiologically relevant variables of lines 4 to 6 from measured variables of the dialysis machine :

• V (urea) (field F 5): volume of distribution of the patient.

Used to convert changes in concentration in

Patient needs on amounts of substance.

• Daily Residual diuresis (field F 6), Na in the urine (field F 7): Is required to calculate the total salt intake. Line 3 includes input elements, the values of which can come from different sources:

• Plasma sodium (pre) (field F 8): plasma sodium des

Patients at the start of dialysis. This value can be preset from electronic records, e.g. B. from current or historical laboratory data. Manual entry at the beginning of treatment is also possible. In the course of the treatment, this value is automatically determined by the device and the initial value is replaced by the determined value.

Line 4 includes display elements that display the

Mark treatment progress:

• V (UF) act (field F 9): amount of liquid removed by ultrafiltration up to the current point in time

• Total Na distance (field F 10): up to the current one

Time in total amount of salt removed by ultrafiltration and diffusion (possible display in different units)

• Na distance diffusive (field F 11): up to the current one

Time amount of salt removed by diffusion. This can be positive or negative. A negative value corresponds to salt transfer into the patient.

• Free water removal (field F 12): up to the current one

Time reached "free water removal" as volume. Since the free water removal is included in the plasma sodium (pre) value displayed here, which is initially only available as an estimate, in addition to the numerical display of the value, an identification can be made here as to whether it is a preliminary Calculation based on estimated values or an updated or even final calculation based on intradialytic measurement values.

Line 5 includes display elements for the salt intake

Patients:

• "Interdialytic salt intake" (field F 13): calculated from residual diuresis and sodium in the urine, as well as the total

Sodium removal (ultrafiltration and diffusion) during dialysis. At the beginning of the treatment, the prescription values are used and the displayed result, as in the case of the "Free water distance" display, is marked as an estimated value. Up to the end of the treatment, the accuracy is then gradually improved with the measured values obtained during the treatment

Sodium balance, which can also be made visible. In addition, because of the uncertainty of determining the sodium content in urine instead of a

individual value for interdialytic salt intake, a range of values corresponding to a confidence interval can be displayed. The physical unit can be selected.

• "Daily salt intake since last dialysis" (field F 14): as described, display modalities as above. The number of days required for the calculation since the last dialysis can be accessed by accessing an internal or

external storage medium showing the date of

previous dialysis of the patient received, determined or entered by means of the input device 103.

• "Average daily salt intake" (field F 15): as described, display modalities as above. For this purpose, e.g. by accessing an external or internal Storage medium or, after input, the values determined in previous dialyses are used.

Line 6 includes display elements for the patient's drinking quantity:

• "Interdialytic excess drinking volume" (field F 16):

Drinking amount that leads to a change in

Plasma sodium concentration has led; positive if the plasma sodium concentration has decreased. The

Calculation can be done according to formula 10, based on the

current prescription, or Formula 11 based on plasma sodium level at the end of the previous one

Treatment, read from an internal or external

Storage medium. As with the values in line 5, the temporary use of estimates can be visualized

• "Daily excess drink since last dialysis"

(Field F 17): Calculation analogous to "Daily salt intake since last dialysis"

• "Average daily excess drinking" (field F 18): Calculation analogous to "Average daily salt intake" from field F15

3 shows a computing device 100 according to the invention for determining an interdialytic one

_Sodium intake _with a patient and / or to determine a mostly non-osmotically based interdialytic

Fluid intake V _exC es _S drink.

The computing device 100 has a

Storage device 101 and / or an input device 103 on. They are used to save or enter

Parameter values of the patient.

The computing device 100 further comprises a

Computing device 105. It is configured to calculate the interdialytic sodium intake _under the

Patient and / or to calculate his non-osmotically based interdialytic fluid supply V _exC ess drink. Corresponding algorithms and formulas, for example as disclosed herein, can for this purpose be stored in the computing device 105 or can be read out by this from suitable sources, for example the storage device 101.

Finally, the computing device 100 has a

Output device 107 off. It is used to output a signal for controlling or regulating an optional

Communication device 109 and / or the medical blood treatment device 4.

The communication device 109 can be configured for a wired or wireless signal connection to a component of the medical blood treatment device 4, e.g. B. their control or regulating device 29.

The communication device 109 can additionally or alternatively be connected to an optionally provided display device or be designed as such. The display device 109 can be or have the user interface shown in FIG. 2.

Communication device 109 can, in particular as

Display device configured, part of the Be the computing device 100 or the medical blood treatment device 4.

Where this is not technically impossible, some of the aforementioned devices can be combined to form a common unit.

Reference character list

1 extracorporeal blood circulation

2 blood cassette

4 blood treatment device

5 access device, for example arterial

Incision needle

6 arterial patient hose clamp

7 venous patient hose clamp

8 supply line

9 arterial section or arterial

Blood collection line or arterial patient line

11 blood pump

13 Addition point for substituate (predilution)

14 Addition point for substituate (post-dilution)

15 arterial air-blood detector

17 conveyor device, for example a

Substituate pump

17a substituate line

18 automatic substituate port

19 blood filters

19a blood chamber

19b dialysis fluid chamber

21 venous air separation chamber

23 venous section or venous blood return line or venous patient line

23a venous section

24 connection point, connection section

25 venous substituate blood detector

26 compressed air source

27 Access device, for example venous

Connection needle 29 control and / or regulating device 31a dialysis fluid supply line

31b dialysate drain line

33a pressure sensor

33b pressure sensor

35 single needle valve

36 single needle chamber

37 pressure sensor

41 connector

100 calculation device

101 storage device

103 Input device

105 computing device

107 output device

109 communication and / or display device

F 1 to F 16 display fields of the interface

V24 valve

V25 valve

Claims

Expectations

1. Calculation device (100) for determining a

Interdialytic sodium supply (niinter) of a patient and / or to determine an interdialytic, in particular non-osmotically based

Fluid supply (V _exC ess drink), _comprising : a storage device (101) and / or a

Input device (103) configured to store or enter parameter values of the patient; a computing device (105) configured to calculate the interdialytic results

Sodium intake (npnter) of the patient and / or to calculate an interdialytic - in particular non-osmotically based -

Fluid intake (V _exC ess drink) of the patient; and an output device (107) for outputting a signal for controlling or regulating a

Communication device (109) and / or a medical blood treatment device (4).

2. Calculating device (100) according to claim 1, wherein the computing means (105) for calculating the

Interdialytic sodium supply (np _nter ) of the dialysis patient and / or his interdialytic fluid supply (V _exC ess drink) is configured to the interdialytic sodium supply (rninter) and / or the interdialytic

_Calculate fluid intake (V _exC ess drink) based on the plasma sodium concentration (c _pr e (n)) and / or the sodium concentration in the urine (c _U nne) at the beginning of the dialysis session (s).

3. Computing device (100) according to claim 1 or 2, wherein the computing device (105) is configured to be in signal communication with the medical

Blood treatment device (4) to stand in such a way that several times during one means of the medical

Blood treatment device (4) expiring

Dialysis session (s) from the medical

Blood treatment device (4) to query or receive measured values from the medical blood treatment device (4) in order to calculate the interdialytic sodium _supply (np _nter) and / or the interdialytic

Repeat or clarify fluid intake (V _exC ess drink).

4. Calculation device (100) according to one of the

preceding claims, wherein the

The output device (107) is configured to display the interdialytic sodium supply (np _nter) and / or the interdialytic fluid supply (V _exC ess drink) on a display device as

Display, output and / or store communication device (109) which is or has a monitor, a display, a printer, a storage element or a database.

5. computing device (100) according to any one of the preceding claims, wherein the

Computing device (105) and / or the

Output device (107) are configured to

calculated values, in particular the sodium intake carried out interdialytically (minter) and / or the

interdialytic fluid supply (V _exC ess drink), _dispensing , storing and / or on the

Display the display device as a communication device (109), together with an indication of a qualitative and / or quantitative accuracy of the displayed, output and / or stored value.

6. Calculation device (100) according to one of the

preceding claims, wherein the specification of the

qualitative and / or quantitative accuracy of the displayed value, the specification of a value range, a confidence interval, a representation in one of several predetermined colors, the size of an error, an uncertainty, a possible value range, in particular a confidence interval, the specification of a standard deviation, variance, a Color coding with optionally several colors and / or a traffic light display is or includes.

7. Calculation device (100) according to one of the

preceding claims, wherein the

Output device (107) for outputting a signal for controlling a communication device (109)

configured to prescribe based on interdialytic sodium intake (minter) and / or the interdialytic

_Indicate fluid intake (V _exC ess drink).

8. Calculation device (100) according to one of the

preceding claims, wherein the

Output device (107) is configured to use the signals it outputs to the medical blood treatment device (4) to send the medical

To control the blood treatment device (4) in such a way that the dialysis session (s) ends when or after the determined, interdialytic sodium _supply ( _min) and / or to the treated blood

Fluid supply (V _eX cess dnnk) is withdrawn.

9. Calculation device (100) according to one of the

preceding claims, configured to read in values of at least one or more of the following parameters:

V volume of distribution of the patient;

A interdialytic excess fluid

corresponding to the interdialytic

Weight gain; Plasma sodium concentration at the beginning of the

Dialysis session (s); cpoetC ^{n ~} l) plasma sodium concentration at the end of the

previous dialysis session (n-1); i'urine accumulated residual excretion between the

Dialysis sessions; duri »Sodium concentration in urine; and

Number of days between the end of the last dialysis session and the current dialysis session, determined from the current date and the saved date of the previous one

Dialysis session.

10. Medical blood treatment device (4) with

Fluid lines, which at least one

Dialysis fluid supply line (31a) and / or a dialysate drain line (31b), which are optionally connected to one another in fluid connection, for example by means of a connector (41); at least one delivery device for delivering a dialysis fluid within the dialysis fluid inlet line (31a) and / or the dialysate drain line (31b); at least one control and / or

Control device (29); wherein the medical blood treatment device (4) is configured to use

Dialysis fluid supply line (31a) and by means of dialysate drain line (31b) each with one

Dialysis fluid chamber (19b) of a blood filter (19) to be connected, which in addition to the dialysis fluid chamber (19b) has a blood chamber (19a), the dialysis fluid chamber (19b) and blood chamber (19a) being separated from one another by a semipermeable membrane; wherein the control and / or regulating device (29) is configured to initiate or effect a blood treatment by means of the medical blood treatment device (4) by means of hemofiltration, hemodialysis or hemodiafiltration, for which the control and / or regulating device (29) with a

Calculating device (100) according to one of the

preceding claims in signal transmission is connected or has such.

11. Medical blood treatment device (4) according to

Claim 10, suitable and / or configured for

Carrying out a blood treatment, in particular hemodialysis, hemofiltration, a

Hemodiafiltration or a separation procedure.