EP4096739A1

EP4096739A1 - Method and devices for determining a time for collecting pressure-measurement values

Info

Publication number: EP4096739A1
Application number: EP21703617.7A
Authority: EP
Inventors: Maria MILLÁN-GALANTE
Original assignee: Fresenius Medical Care Deutschland GmbH
Current assignee: Fresenius Medical Care Deutschland GmbH
Priority date: 2020-01-31
Filing date: 2021-01-27
Publication date: 2022-12-07
Also published as: DE102020102471A1; CN115038474A; CA3168440A1; KR20220131994A; AU2021213898A1; JP2023517466A; WO2021151932A1; US20230057779A1

Abstract

The present invention relates to a method for determining a time (t1, …, t5) for measuring pressure values of a patient, or for recommending such a time, during a blood treatment session. The method comprises monitoring the ultrafiltration rate (UF_rate) at which the patient's blood is treated, the relative blood volume (RBV) and/or a sodium concentration ([Na⁺]) or a change thereto for the presence or fulfilment in each case of a predefined criterion for corresponding values or the change thereto. The method also comprises transmitting a signal to a provided blood-pressure measuring device (700) if or as soon as the predefined criterion is fulfilled for the ultrafiltration rate (UF_rate), for the relative blood volume (RBV) and/or for the sodium concentration ([Na⁺]) or the change thereto.

Description

description

Methods and devices for determining a point in time for collecting pressure measured values

The present invention relates to a method according to claim 1. It also relates to a control or regulating device according to claim 6 and a medical set according to claim 9. Furthermore, the present invention relates to a digital storage medium according to claim 14, a computer program product according to claim 15 and a computer program according to claim 16.

Extracorporeal blood treatment by means of dialysis is known from practice. In this case, blood is taken from the patient, which is transported extracorporeally along a blood circuit and z. B. is passed through a blood filter. The blood filter has a blood chamber through which blood is passed and a dialysis fluid chamber through which

Dialysis fluid is performed on. Both chambers are separated from each other by a semi-permeable membrane. Blood and dialysis fluid are mostly passed through the blood filter using the counterflow principle. The blood is cleaned in the blood filter, the dialysis fluid is considered to be used up when it exits the blood filter and is discarded, now referred to as effluent. In addition to the dialysate, the effluent to be discarded also includes filtrate (or ultrafiltrate), which includes water that has been withdrawn from the blood in the blood filter. In the following, the filtrate and dialysate are referred to individually or collectively as the effluent. In addition to acute cases, dialysis is mainly used in patients with terminal kidney failure. Patients with end-stage renal failure are only able to excrete toxins and fluids (water) that have accumulated in the body to a limited extent or at all. These patients are therefore dependent on this accumulation being regularly reduced by the extracorporeal method of dialysis. Most patients typically have hemodialysis treatment three times a week. In addition to removing substances such as urea and potassium, an essential task of dialysis is to reduce the overhydration of the patient resulting from fluid intake by withdrawing fluid from the blood, so that the patient ideally reaches his dry weight again after dialysis.

In the body, water is distributed over various physiological compartments, which can be divided into intracellular space, extracellular space and the interstitium (Guyton & Hall, Textbook of Medical Physiology, Elsevier Saunders Verlag, Philadelphia (USA), 11th edition, 2006) .

The distribution to these compartments is mainly determined by the osmotic equilibrium, to which the sodium content in these compartments makes the main contribution. During hemodialysis, both an exchange of substances with the blood and a removal of fluid from the blood take place in the dialyzer. After the blood has returned to the body, a new equilibrium is established there through the flow of fluid from other areas of the body and through the equalization of the substance concentration. However, these processes require a certain amount of time, so that it can happen that the withdrawal of fluid from the blood by means of dialysis takes place faster than the subsequent flow of body water. This increases the volume (or amount) of water in the blood vessels is reduced, this leads to a drop in blood pressure and possibly a critical drop in blood pressure during dialysis.

It is an object of the present invention to propose a method for establishing a point in time for a pressure measurement, in particular blood pressure measurement, during the blood treatment session.

Furthermore, a control or regulating device, a medical set, a suitable digital storage medium, a suitable computer program product and a suitable computer program are to be specified.

The object according to the invention is achieved by the method with the features of claim 1, a control or regulating device with the features of claim 6 and a medical set with the features of claim 9. The object according to the invention is also achieved by a digital storage medium, a computer program product and a computer program according to claims 14, 15 and 16.

The method according to the invention relates to establishing a point in time for a pressure measurement on a patient, or to recommend that a pressure measurement be carried out. Here, the point in time of the recommendation and indirectly also of the measurement lies or will lie there during a treatment session. The treatment of the patient is one in which the patient's blood extracorporeally by means of a

Blood treatment device, in particular by performing the process of ultrafiltration, is treated.

The method according to the invention comprises monitoring (alternatively observing or following) during the Treatment session or during at least one phase thereof, the ultrafiltration rate with which the patient's blood is or will be treated, the relative blood volume of the patient and / or a sodium concentration (hereinafter also: [Na ⁺ ]). The monitoring can be or comprise the determination of a change in each of these values over time.

In particular, these values (ultrafiltration rate, relative blood volume and / or sodium concentration) or their change are monitored for the presence or fulfillment of a predetermined criterion in each case.

The method according to the invention further comprises the transmission of a signal to a provided one

Blood pressure measuring device. The signal is transmitted if or when or as soon as the predetermined criterion for the ultrafiltration rate, for the relative blood volume and / or for the sodium concentration or in each case for the change thereof is met.

Optionally, the method according to the invention also includes the provision of the blood pressure measuring device which is suitable and / or prepared for collecting blood pressure measured values of the patient.

The present invention further relates to a control or regulating device. It is configured or programmed to carry out and / or to initiate the method according to the invention or its machine steps, e.g. B. on a blood pressure measuring device provided, in particular in each of the embodiments described herein and in each possible combination of features disclosed herein, in particular of method steps.

The control or regulating device can have devices, or be connected to them in signal communication, which can execute the individual method steps or features as disclosed herein - and in particular in the claims - and are designed, configured and / or programmed accordingly for this purpose. These facilities can be named according to the step they perform or can perform.

A medical set according to the invention (also in this context: set for short) has a control or regulating device according to the invention and a blood pressure measuring device. Here, the control or regulating device and the blood pressure measuring device are in signal communication with one another.

Signal communication can include the sending and / or receiving or transmission of information, as well as the exchange of information or a configuration for this. As an example of information that the control or regulating device transmits to the blood pressure measuring device in some embodiments, a signal for preparing a blood pressure measurement, e.g. B. to inflate a

Blood pressure cuff, called. In addition or as an alternative, for example, a blood pressure measured value determined by the blood pressure measuring device can be transmitted by the latter to the control or regulating device, for example for further processing thereof. A digital, in particular non-volatile, storage medium according to the invention, in particular in the form of a machine-readable carrier, in particular in the form of a floppy disk, memory card, CD, DVD, Blu-ray Disc or (E) EPROM, FRAM (Ferroelectric RAM) or SSD (Solid-State -Drive) with electrically readable control signals, can in this way with a programmable control or regulating device

Cooperation that the, in particular machine, steps of the method according to the invention are initiated.

All, some or some of the steps of the method according to the invention that are carried out, in particular by machine, can be initiated.

As an alternative or in addition to this, the digital storage medium according to the invention can be configured so that a conventional control or regulating device can be reprogrammed into a control or regulating device according to the invention.

A computer program product according to the invention has a volatile, volatile program code or program code stored on a machine-readable carrier to initiate the, in particular machine, steps of the method according to the invention when the computer program product runs in a control or regulating device. According to the invention, a computer program product can be, for example, a computer program stored on a carrier, an embedded system as a comprehensive system with a computer program (e.g. electronic device with a computer program), a network of computer-implemented computer programs (e.g. client / server system, Cloud computing system, etc.) or a computer on which a computer program is loaded, expires, is stored, executed or developed can be understood.

As an alternative or in addition to this, the computer program product according to the invention can be configured to reprogram a conventional control or regulating device into a control or regulating device according to the invention.

In certain embodiments of the present invention, the term “machine-readable carrier” as used herein denotes a carrier that contains data or information that can be interpreted by software and / or hardware. The carrier can be a data carrier, such as a floppy disk, CD, DVD , a USB stick, a flash card, an SD card or the like as well as any other storage device mentioned herein or any other storage medium mentioned herein.

A computer program according to the invention has a program code to initiate the, in particular machine, steps of the method according to the invention when the computer program runs on a control or regulating device. According to the invention, a computer program can be understood to mean, for example, a physical, marketable software product which has a program.

As an alternative or in addition to this, the computer program according to the invention can be configured to reprogram a conventional control or regulating device into a control or regulating device according to the invention.

It also applies to the computer program product according to the invention and the computer program according to the invention that all, some or some of the steps of the method according to the invention that are carried out, in particular by machine, are initiated.

Embodiments according to the invention can have some, some or all of the following features in any combination, unless this is technically impossible for a person skilled in the art to recognize. Advantageous further developments of the present invention are each also the subject matter of the subclaims.

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

Whenever numerical words are mentioned here, the person skilled in the art understands them to indicate a numerically lower limit. If this does not lead to a contradiction that is recognizable to the person skilled in the art, the person skilled in the art therefore always reads “at least one” or “at least one” with the statement “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 encompassed by the present invention and apply to all numerical words used herein.

If an embodiment is mentioned here, this represents an exemplary embodiment according to the invention. In some embodiments, the criterion does not consist in determining a point in time for a blood pressure measurement on a patient or does not include such a determination.

In some embodiments, the criterion is or does not include a time criterion, such as the question of whether a predetermined period of time has elapsed since a predetermined event, a time or a previous pressure measurement.

In some embodiments, the blood pressure measuring device is part of the blood treatment device or is in signal connection with it during the treatment session and / or it is configured for this and / or the

Blood treatment device set up accordingly, assigned to it or “paired” with it.

In some embodiments, the method does not include an automatic blood pressure measurement, e.g. B. takes place according to predetermined time criteria (such as every 5 minutes).

In some embodiments, the method does not include multiple blood pressure measurements, the distance between which is determined on the basis of a time measurement or just a time measurement.

In some embodiments, the blood treatment device according to the invention comprises sensors which are used upstream and / or downstream of a dialyzer of the blood treatment device in order to measure the electrolyte and / or fluid balance, e.g. B. on the

Dialysis fluid side or machine side and / or on the blood side. You can use to find the

Sodium concentration as discussed herein can be used.

In some embodiments, the

Blood treatment device on a control or regulating device for their control or regulation. The control or regulating device can be one according to the invention. It can be programmed and / or configured in order to supplement the execution or initiation of the method according to the invention in cooperation with further devices, in particular a blood pressure measuring device, the

To control or regulate blood treatment device.

The control or regulating device can be configured to output machine signals that are directed as control signals to the blood treatment device, based on inputs by the doctor, or - alternatively or in addition to this - to create such machine signals based on stored algorithms. So the doctor can z. B. specify which treatment profile is to be used for treatment.

Corresponding and optionally specially provided input fields, switches, regulators, etc. for the doctor can be comprised by the control or regulating device, a display device and / or a section of the blood treatment device.

In some embodiments, the control or regulating device, the blood pressure measuring device, the set or the blood treatment device have devices which are configured to carry out steps of the method according to the invention. This applies to every step disclosed herein. In some embodiments, the method according to the invention runs on a computer or computer. An input option for the user can be provided for necessary inputs. Output or display devices can be provided for displaying results of the method or treatment instructions.

In some embodiments of the method according to the invention, the predetermined criterion for the ultrafiltration rate is met when this, or its change, reaches or exceeds a minimum value.

The predetermined criterion for the ultrafiltration rate is met in some embodiments if the ultrafiltration rate or its change is applied or aimed for over or for a predetermined duration.

Alternatively or additionally, in some embodiments the predetermined criterion for the relative blood volume is met when the relative blood volume or its measured value has reached or fallen below a minimum value and / or when its change (ie its decrease or increase in the measured value over time) reaches a maximum value or has exceeded.

Additionally or alternatively, in some embodiments of the method, the predetermined criterion for the sodium concentration, in particular the sodium concentration of the dialysis fluid or of the dialysate, is met when the sodium concentration falls below a minimum value or its change is exceeded. In addition or as an alternative to this, the predetermined criterion for the ultrafiltration rate, for the relative blood volume and / or for the sodium concentration or the change in each case is fulfilled if a predetermined event for the ultrafiltration rate, for the relative blood volume and / or for the sodium concentration is in the course of a treatment profile for the ultrafiltration rate occurs or is reached. The treatment profile is or will be set on the blood treatment device. Each point of the treatment profile shown as a curve over time can be understood here as an event.

In some embodiments of the method according to the invention, the signal to the blood pressure measuring device provided is or comprises a signal which is used to prepare the blood pressure measuring device for a blood pressure measurement or which initiates a preparation. This preparation can include, in particular, an optional inflation

Be or include blood pressure cuff of the blood pressure measuring device.

In some embodiments, the signal to the provided blood pressure measuring device is a signal for measuring an arterial blood pressure value or for measuring a venous blood pressure value of the patient or for preparing for such a measurement, or comprises such a signal. The signal can trigger such a measurement.

Based on the measured blood pressure values, on the one hand, and all the circumstances that may have influenced the measured values, on the other hand, the doctor can diagnose normotension, possibly existing hypertension or, what is more likely here, hypotension. The circumstances that must be observed in order to make such a diagnosis include, among other things, how the blood pressure measured values of the patient can be classified compared with those of a collective, or whether they have changed over time. This process can be referred to as evaluating.

In some embodiments of the method according to the invention, the monitoring of the ultrafiltration rate, the relative blood volume and / or the sodium concentration is or comprises reading out at least one set treatment parameter or treatment profile or comprises such reading out, e.g. B. from the control or regulating device. This treatment profile can be preset and / or selected on the blood treatment device that is used during the blood treatment session.

In some embodiments of the control or regulating device according to the invention, it is optionally configured to process and / or evaluate the arterial blood pressure measurement value and / or the venous blood pressure measurement value.

The processing and / or evaluation of the arterial blood pressure reading and / or the venous blood pressure reading can lead to the diagnosis of normotension, hypertension or hypotension.

In some embodiments of the control or regulating device according to the invention, this is optionally configured to trigger an alarm. It is complementary or alternative in some

Embodiments for causing an interrupt or

End of ultrafiltration configured.

In some embodiments, the control or regulating device is provided and / or configured, again in addition or as an alternative, to initiate at least one renewed determination of a blood pressure measured value. The determination of the blood pressure measured value can be followed by its processing and / or evaluation.

Alternatively or in addition, the tax or

Controller configured, in some embodiments, to initiate a bolus or an online bolus.

The following can apply to a bolus administration: A sodium concentration of 130-145 mmol / 1 in the dialysis fluid is required for treatment (depending on the patient's experience using a Kt / V measurement on the

Blood treatment device or based on measured or determined blood values) set as the start value. The set Na concentration can usually be adjusted to a maximum of 155 mmol / 1, which takes place in particular if a hypotonic state has been determined.

When giving a bolus, the bolus volume (mostly substitution fluid, administered e.g. via an optional pre- or post-dilution port or through a pre- or post-dilution valve) is between 30-240 ml. This is usually not accounted for. The bolus administration can be triggered on the basis of the values determined by means of conductivity sensors and optionally adjusted with regard to volume and / or sodium or salt content.

In some embodiments, the control or regulating device according to the invention is optionally provided and / or configured in order to output a corresponding note for the user to take note of.

Alarm, interruption, termination, renewed determination, bolus administration and / or instructions can be provided for the case that the evaluation of the arterial blood pressure measurement value and / or the venous blood pressure measurement value shows that the patient is hyper- or hypotonic or has reached a predetermined range of permissible blood pressure measurement values or has been left or the arterial blood pressure measured value and / or the venous blood pressure measured value are below a predetermined minimum value.

In some embodiments of the medical set according to the invention, it also has a blood treatment device. the

Blood treatment device is used for the extracorporeal treatment of a patient's blood, in particular by performing the process of ultrafiltration.

In some embodiments of the medical set, the blood treatment device is designed as a hemodialysis device, hemofiltration device or hemodiafiltration device, in particular as a device for acute or chronic renal replacement therapy. Renal replacement therapy can include continuous or intermittent procedures. In some embodiments, the medical set according to the invention comprises sensors. These are optionally arranged and configured to measure the sodium concentration. The measurement preferably takes place extracorporeally, in particular in the dialysate.

In some embodiments, the control or regulating device is additionally configured or programmed to control or regulate a blood treatment device based on the results of the method. The control or regulation can interrupt or terminate the blood treatment or the ultrafiltration, a reduction or regulation of the ultrafiltration rate, the renewed determination of the arterial blood pressure value and / or the venous blood pressure value, the application of a saline bolus, the treatment based on a modified treatment profile, a change the sodium concentration in the dialysis fluid, v. a. based on the instructions of the doctor, etc. be or include.

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

The determination of the relative blood volume is required regularly to control the fluid withdrawal in the treated patients. As a result of the ultrafiltration, the blood volume and thus also the relative blood volume decrease. Changes in blood volume have an important influence on a patient's intradialytic blood pressure (Drukker, Parsons und Mäh, Replacement of Renal Function by Dialysis, Kluwer Academic Publishers, Dordrecht, 5th edition, 2004). The relative blood volume (short: RBV) can, for example, be determined based on the measurement of the hematocrit:

HTC ₀

RBV = (- 1) 100

HTC- _L where:

HTCo is the hematocrit value at time t = 0 (at the start of treatment) and

HTCi is the hematocrit value at the current point in time

Various physical methods can be used to determine the relative blood volume, e.g. B. Measurement of electrical conductivity, optical density, blood viscosity or physical density, in particular by measuring the speed of sound and / or time of flight.

According to the invention, devices, for example sensors, are provided for determining and / or monitoring the relative blood volume. In this regard, reference is made to the state of the art. Such devices are also referred to herein as blood volume monitors. According to the invention, such a blood volume monitor can be provided.

Some or all of the embodiments according to the invention can have one, more or all of the advantages mentioned above and / or below.

An advantage of the present invention can be improved patient monitoring during a blood treatment session, since patient monitoring takes place primarily in the critical moments of such a blood treatment session. Discharge of the patient from the blood treatment session with a fluid overhang, which is caused by a lowering of the ultrafiltration rate during the treatment session, which was wrongly considered necessary, or the administration of a saline bolus which was not caused by blood pressure, can advantageously be avoided when using the present invention. The patient's tolerance to the blood treatment session can thus be increased indirectly, which can markedly increase the patient's quality of life.

By means of the present invention, in particular by automating the determination of the appropriate, variable times and the associated early detection of pressure changes during a blood treatment session in the patient even without the staff being active, unnecessary stress on the staff can advantageously be avoided.

A further advantage can be the saving of time and attention on the part of the staff at this point.

By means of the present invention, higher ultrafiltration volumes or rates can advantageously be aimed for without risking discomfort for the patient. Moments in which he could feel uncomfortable because of an excessively high ultrafiltration volume or an excessively high ultrafiltration rate can be recorded early according to the invention and thus ultimately advantageously avoided. Another advantage of the present invention is that it is easy to implement.

In practice, the current relative blood volume or its rate of change is regularly compared with a patient-individually definable threshold value and the rate of fluid withdrawal is reduced when the threshold value is exceeded. This can lead to the permanently withdrawn at the end of the dialysis

Liquid volume is less than planned and thus the dry weight is not reached. These circumstances can advantageously be avoided according to the invention, since z. B. the ultrafiltration rate required to achieve the dry weight in the time available can be applied. Should discomfort occur here, this could be recognized according to the invention. So she has to

The ultrafiltration rate cannot be lowered purely prophylactically to avoid discomfort on the part of the patient.

All the advantages that can be achieved with the method according to the invention can also be achieved undiminished in certain embodiments according to the invention with the devices according to the invention, and vice versa.

In the following, the present invention is described purely by way of example with reference to the accompanying figures. In them, the same reference symbols denote the same or the same components. The following applies:

Fig. 1 shows a simplified, schematic representation of a blood treatment device according to the invention with an extracorporeal blood circuit in a first embodiment or the representation of a Flow diagram of a blood treatment device according to the invention, exemplarily designed as a hemodiafiltration device;

FIG. 2 shows examples for the implementation of the method according to the invention with reference to a graphic representation of an exemplary treatment profile; FIG.

3a shows a first alternative treatment profile of a blood treatment by means of ultrafiltration;

3b shows a second alternative treatment profile of a blood treatment by means of ultrafiltration;

4 shows an example of the stipulation of times (tl,..., T5) within a blood treatment by means of ultrafiltration in a graphical representation of an exemplary treatment profile which was adapted based on the method according to the invention; and

FIG. 5 shows examples of the implementation of the method according to the invention with reference to a graphic representation of a further exemplary treatment profile.

Fig. 1 shows an extracorporeal blood circuit 300, which for a treatment by means of double-needle access, or using z. B. an additional Y-connector (reference symbol Y) as shown in Fig. 1 can be connected to the vascular system of the patient, not shown, by means of single-needle access. The bloodstream 300 can optionally present in sections thereof in or on a blood cassette.

Pumps, actuators and / or valves in the area of the blood circuit 300 are equipped with a blood treatment device 100 according to the invention or with one of these e.g. B. comprised control device 150 connected.

The blood circuit 300 has an arterial patient hose clamp 302 and an arterial connection needle of an arterial section or an arterial patient line, blood sampling line or first line 301 (or is connected to it). The blood circuit 300 also has a venous one

Patient hose clamp 306 and a venous connection needle of a venous section, a venous patient line, blood return line or second line 305 (or is connected to it).

A blood pump 101 is provided in or on the first line 301, and a substituate pump 111 is connected to a dialysis fluid supply line 104 for conveying fresh dialysis fluid which is filtered (substituate) in a further filter stage (F2). A substituate line 105 can be fluidically connected to the feed line 104. Using the

Substituate pump 101 can supply substituate by pre-dilution, via a pre-dilution valve 107, or post-dilution, via a post-dilution valve 109, via associated lines 107a or 109a in line sections, for example in the arterial line section 301 or in the venous

Line section 305 (here between a blood chamber 303b of a blood filter 303 and a venous air separation chamber or venous blood chamber 29) of the blood circuit 300 can be introduced.

The blood filter 303 has the arterial line section 301 and the venous

Line section 305 connected blood chamber 303b. 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 a dialysate drain line 102 leading away from the dialysis fluid chamber 303a, which carries dialysate, i.e. used dialysis fluid.

Dialysis fluid chamber 303a and blood chamber 303b are separated from one another by a mostly semi-permeable membrane 303c. It represents the separating sheath between the blood side with the extracorporeal blood circuit 300 and the machine side with the dialysis fluid or dialysate circuit, which is shown in FIG. 1 to the left of the membrane 303c.

The arrangement of FIG. 1 comprises an optional detector 315 for detecting air and / or blood. The arrangement of FIG. 1 further comprises one or two pressure sensors PSI (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 those shown in FIG Further pressure sensors can be provided, for example the pressure sensor PS3 downstream of the venous bladder chamber 29.

An optional single-needle chamber 317 is used in FIG. 1 as a buffer and / or compensation container in a single-needle method in which the patient only uses one of the two blood lines 301, 305 is connected to the extracorporeal blood circuit 305.

The arrangement of FIG. 1 also includes an optional detector 319 for detecting air bubbles and / or blood.

An addition point 25 for heparin can optionally be provided.

A mixing device 63 is shown on the left in FIG. 1, which consists of the containers A (for A concentrate via the concentrate supply 67) and B (for B concentrate via the concentrate supply 69) a predetermined mixture for the respective solution for use by the Blood treatment device 100 provides. The solution contains, in z. B. the heating device 61 warmed water (online, z. B. as reverse osmosis water or from bags) from the water source 55.

A pump 71, which can be referred to as a concentrate pump or a sodium pump, is fluidly connected to the mixing device 63 and a source of sodium, for example the container B, and / or conveys therefrom.

A drain 53 for the effluent can also be seen in FIG. 1. An optional heat exchanger 57 and a first flow pump 59, which is suitable for degassing, complete the arrangement shown.

Another pressure sensor can be used as 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 for measuring the filtrate pressure or Membrane pressure of the blood filter 303 may be provided. Further, optional pressure measuring points P can also be provided.

Blood leaving the blood filter 303 flows through an optional venous blood chamber 29, which has a venting device 31 and can be in fluid connection with the pressure sensor PS3.

The exemplary arrangement shown in FIG. 1 has the control or regulating device 150. It can be in wired or wireless signal connection with any of the components mentioned herein - at least or in particular with the blood pump 101 - for controlling or regulating the blood treatment device 100. It is optionally configured to carry out the method described herein, in particular automatically.

By means of the device for online mixing of the dialysis fluid, a variation of its sodium content, controlled by the control device 150, is possible within certain limits. For this purpose, in particular the measured values determined by means of conductivity sensors 163a, 163b can be included. There should be an adjustment of the sodium content of the dialysis fluid

(Sodium concentration) or the substituate result as required or desired, this can be done by adapting the delivery rate of the sodium pump 71.

In addition, the blood treatment device 100 comprises means for conveying fresh dialysis fluid and dialysate. For this purpose, the first flow pump 59 is provided upstream of the blood filter 303, which fresh Promotes dialysis fluid in the direction of the blood filter 303. A first valve can be provided between the first flow pump 59 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 e.g. B. is provided downstream of the blood filter 303, which conveys dialysate to the drain 53. 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 device 161 for balancing is preferably arranged in a line region between the first flow pump 59 and the second flow pump 169.

The blood treatment device 100 further comprises means for the exact removal of a liquid volume predetermined 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. Temperature values supplied by them can be used according to the invention to determine a temperature-compensated conductivity.

A leakage sensor 167 is optionally provided. Other river pumps in addition to or as an alternative to z. B. those with the reference number 169 can also be provided.

A number of optional valves are each designated by V in FIG. 1. Bypass valves are labeled VB.

In some embodiments, the control device 150 determines the electrolyte and / or liquid balance based on the measured values of the aforementioned optional sensors.

Filters F1 and F2 can be connected in series.

The filter Fl serves here as an example to generate sufficiently pure dialysis fluid by means of the mixing device 63 even using non-pure water, which then, for. B. in the countercurrent principle, flows through the blood filter 303.

The filter F2 is used here by way of example to remove the sufficiently pure dialysis fluid that leaves the first filter F1 by filtering z. B. pyrogenic substances to generate sterile or sufficiently filtered substituate, which can be safely fed to the patient's extracorporeal blood and thus ultimately to the patient's body.

Fig. 1 shows that the control device 150 of the blood treatment device 100 can be wired or wireless with a blood pressure measuring device 700 and / or with a blood volume monitor 800 in signal connection and for this purpose, z. B. by appropriate mutual Programming and coordination with one another, configured and prepared.

The optional blood treatment device 100 of the set according to the invention is shown in FIG. 1 as a device for hemo (dia) filtration. Hemodialysis devices, however, also fall under the present invention, although not specifically shown by means of the figure.

The present invention is not limited to the embodiment described above, this is for illustrative purposes only.

The arrowheads shown in FIG. 1 generally indicate the direction of flow in FIG. 1.

Fig. 2 shows examples of times t1,..., T5 established according to the invention within the time sequence of an exemplary treatment profile; . Shown in unit h).

Such a treatment profile can, for example, be stored in the blood treatment device and can be selected by the doctor or qualified treatment personnel for the treatment of a specific patient.

The example shown shows a treatment profile with alternating, clear changes between lower and higher ultrafiltration rates UF_rate. The sections of the treatment profile with the higher ultrafiltration rates can also be referred to as peaks, since they represent the peaks of the Ultrafiltration rate UF_rate correspond to the course of the treatment profile over time.

With knowledge and on the basis of the stored treatment profile or its predetermined course, the method according to the invention can determine ad hoc or in advance at which times t1,. Since, above all, high ultrafiltration rates UF_rate are generally more poorly tolerated by the (respective) patient, the end of such a peak is suitable for determining the current state of the patient, in particular for causing his current blood pressure measurement values to be determined. These times t1,..., T5 are identified in the diagram of FIG. 2 with an "x".

Alternatively or in addition, if the course of the treatment profile is known, the duration D of such a peak can be used to establish at least one point in time t1,..., T5. For the sake of clarity, the duration D is indicated with reference symbols only at a peak in FIG. 2.

A transmission of a corresponding signal to the blood pressure measuring device 700 initiated at such a point in time t1,. After processing the measured blood pressure measured value, for example in the control or regulating device 150 (see FIG. 1), this can be used to select an alternative treatment profile (see FIGS. 3a and 3b) or to modify the course of the selected treatment profile (see FIG. 4 ), with which in the further course of the Blood treatment session should preferably be treated further.

The number of times defined according to the invention (here five) is purely exemplary and is in no case to be understood as limiting.

Fig. 3a shows a first alternative treatment profile of a blood treatment by means of ultrafiltration.

A blood pressure measured value measured at a point in time determined by the method according to the invention can show that the ultrafiltration rate UF_rate of the selected treatment profile (for example the treatment profile with alternating changes in FIG. 2) is not tolerated sufficiently well by the treated patient. As a first alternative treatment profile, which could be used if the criteria mentioned above are met, a linear course of the

Ultrafiltration rate UF_rate can be mapped. As can easily be seen, the ultrafiltration rate UF_rate in this example of a treatment profile decreases linearly from the beginning to the end during the blood treatment session.

It can be assumed that a decreasing

Ultrafiltration rate UF_rate can be more easily tolerated by a patient who did less well with the treatment profile of FIG. 2.

Fig. 3b shows a second alternative treatment profile of a blood treatment by means of ultrafiltration. Analogously to FIG. 3a, it is again assumed in this example that the ultrafiltration rate UF_rate of the selected treatment profile (for example the treatment profile with alternating changes in FIG. 2) was not tolerated sufficiently well by the treated patient. As a second alternative treatment profile, which could be used if the criteria mentioned above are met, a step-shaped course of the ultrafiltration rate UF_rate should be mentioned here as an example. As can be clearly seen, the ultrafiltration rate UF_rate decreases in this example of a treatment profile during the blood treatment session from the beginning to the end, for example twice by one level each.

Here, too, it can be assumed that the decreasing ultrafiltration rate UF_rate can be more easily tolerated by the treated patient. According to the invention, another signal can be sent to the blood pressure measuring device 700 at the times marked with "x", which can in particular be determined by the method according to the invention, which can be followed by a determination of a further blood pressure measured value and its evaluation and / or processing. It can then be provided according to the invention at these points that

To lower or maintain the ultrafiltration rate UF_rate according to the blood pressure measured value determined.

In some embodiments, it can be envisaged to increase the ultrafiltration rate UF_rate again based on the determination and evaluation or processing of measured blood pressure values or to return to a previously used treatment profile. Fig. 4 shows an example of the stipulation of points in time t1,.

As with FIG. 3a, it is again assumed in this example that the ultrafiltration rate UF_rate of the selected treatment profile (for example the treatment profile with alternating changes in FIG. 2) was not tolerated sufficiently well by the treated patient, but this was recognized at the first point in time t1 became. In contrast to the treatment profile of FIG. 2, the treatment profile selected by the doctor is changed here in such a way that the height of the peaks of the ultrafiltration rate UF_rate is adjusted, for example lowered, on the basis of the blood pressure measured value determined at time tl, which was established according to the invention. The different heights of the peaks of the ultrafiltration rate UF_rate before and after the adaptation of the ultrafiltration rate UF_rate are illustrated in FIG. 4 by two horizontal dotted lines.

It is conceivable that the ultrafiltration rate UF_rate in such embodiments with good tolerability of the patient, i. H. in connection with blood pressure readings measured later, which are again acceptable, also to be adjusted upwards again. This is indicated in FIG. 4 in the time course of the treatment profile following the times t3 and t4 marked with “x”.

Fig. 5 shows that what is stated herein in the description of the figures relating to the criteria of the ultrafiltration rate UF_rate analogously without restriction also applies to the criteria of the relative blood volume RBV or the criteria of the sodium concentration [Na ⁺ ] within a blood treatment session.

List of reference symbols

25 addition point for heparin (optional)

29 venous blood chamber (optional)

31 Ventilation device

53 drain

55 water source

57 heat exchangers

59 first flow pump

61 heater

63 Mixing device

67 Concentrate supply

69 Concentrate supply

71 concentrate pump; Sodium pump

100 blood treatment device

101 blood pump

102 Dialysate drain line, effluent inlet line

104 dialysis fluid supply line

105 Substituate line 107 Pre-dilution valve 107a Line 109 Post-dilution valve 109a Line 111 Pump for substituate 121 Pump for dialysis fluid 131 Pump for dialysate or effluent

150 control or regulating device

161 device

163a conductivity sensor

163b conductivity sensor

165a temperature sensor

165b temperature sensor 167 leakage sensor

169 second flow pump

300 extracorporeal blood circulation

301 first line (arterial line section)

302 (first) hose clamp

303 blood filter or dialyzer 303a dialysis fluid chamber 303b blood chamber 303c semi-permeable membrane

305 second line (venous line section)

306 (second) hose clamp 315 Detector 317 Single-needle chamber 319 Detector

700 blood pressure measuring device

800 blood volume monitor

Fl filter

F2 filter

A container

B container

D predetermined duration

[Na ⁺ ] sodium concentration

P pressure measuring points PSI arterial pressure sensor (optional)

PS2 arterial pressure sensor (optional)

PS3 pressure sensor (optional)

PS4 pressure sensor for measuring the filtrate pressure (optional) RBV relative blood volume tl time UF_rate ultrafiltration rate

V valves VB bypass valves

Y Y connector

Claims

Expectations

1. Method of defining at least one

Point in time (tl, ..., t5) for a measurement of pressure values on a patient, or to recommend such, during a treatment session in which the patient's blood is extracted extracorporeally by means of a blood treatment device (100), in particular by performing (the process) an ultrafiltration, the method comprising the steps of:

Monitoring, during the treatment session or during at least one phase thereof, an ultrafiltration rate (UF_rate) with which the patient's blood is treated, a relative blood volume (RBV) and / or a sodium concentration ([Na ⁺ ]) or a change thereof in each case the presence or fulfillment of a predetermined criterion for the ultrafiltration rate (UF_rate), for the relative blood volume (RBV) and / or for the sodium concentration ([Na ⁺ ]) or the change thereof;

Transmission of a signal to a blood pressure measuring device (700) provided if or as soon as the predetermined criterion for the

Ultrafiltration rate (UF_rate), for the relative blood volume (RBV) and / or for the sodium concentration ([Na ⁺ ]) or in each case the change thereof is fulfilled.

2. The method according to claim 1, wherein the predetermined criterion for the ultrafiltration rate (UF_rate) is met if a minimum value for the

Ultrafiltration rate (UF_rate) or its change has been reached, exceeded or applied or aimed for over a predetermined duration (D); and / or wherein the predetermined criterion for the relative blood volume (RBV) is met when the relative blood volume (RBV) is undershot or its change is exceeded; and / or wherein the predetermined criterion for the

Sodium concentration ([Na ⁺ ]), in particular in the dialysis fluid or in the dialysate, is fulfilled when a minimum value of the

Sodium concentration ([Na ⁺ ]) has fallen below or its change has been exceeded; and / or wherein the predetermined criterion for the ultrafiltration rate (UF_rate), for the relative blood volume (RBV) and / or for the sodium concentration ([Na ⁺ ]) or the change in each case is met if a predetermined event in the course of one of the

Blood treatment device (100) set treatment profile for the

Ultrafiltration rate (UF_rate), for the relative blood volume (RBV) and / or for the Sodium concentration ([Na ⁺ ]) occurs or is reached.

3. The method according to claim 1 or 2, wherein the signal to the provided blood pressure measuring device (700) is a signal for preparing the

Blood pressure measuring device (700) is or comprises a process for measuring blood pressure measured values of the patient, in particular an inflation of a blood pressure cuff of the blood pressure measuring device (700).

4. The method according to any one of the preceding claims, wherein the signal to the provided blood pressure measuring device (700) is or comprises a signal for measuring an arterial blood pressure measured value or venous blood pressure measured value of the patient.

5. The method according to any one of the preceding claims, wherein the monitoring of the ultrafiltration rate (UF_rate), the relative blood volume (RBV) and / or the sodium concentration ([Na ⁺ ]) set a readout of at least one on the blood treatment device (100) used during the blood treatment session Treatment parameter or profile is or includes.

6. Control or regulating device (150) configured to carry out the mechanical steps of the method according to one of claims 1 to 5.

7. Control or regulating device (150) according to claim 6, configured for processing and / or evaluating the arterial blood pressure reading and / or venous blood pressure reading.

8. Control or regulating device (150) according to claim 7, configured to trigger an alarm, to initiate an interruption or termination of the ultrafiltration, to initiate a renewed determination of a blood pressure measurement and its evaluation, to initiate an online bolus administration and / or configured for Outputting appropriate information for the user to take note of, should the evaluation of the arterial blood pressure measured value and / or the venous blood pressure measured value show that the patient's blood pressure has reached or left predetermined ranges.

9. Medical set, comprising a control or regulating device (150) according to one of claims 6 to 8; and a blood pressure measuring device (700); wherein the control device (150) and the blood pressure measuring device (700) are in signal communication with each other.

10. The medical set according to claim 9, further comprising a blood treatment device (100) for the extracorporeal treatment of the patient's blood, in particular by performing (the process) an ultrafiltration.

11. Medical set according to claim 10, wherein the blood treatment device (100) is designed as a hemodialysis device, hemofiltration device or hemodiafiltration device, in particular as a device for acute or chronic renal replacement therapy

12. The medical kit of claim 11, wherein the renal replacement therapy comprises continuous or intermittent procedures.

13. Medical set according to one of claims 9 to 12, with sensors (163a, 163b, 165a, 165b, 800), arranged and configured to, preferably extracorporeally, the sodium concentration ([Na ⁺ ]), in particular in the dialysis fluid, im Dialysate, and / or measure the relative blood volume (RBV).

14. Digital storage medium, in particular in the form of a diskette, memory card, CD, DVD, Blu-ray Disc or (E) EPROM with electrically readable control signals, configured to interact with a programmable control or regulating device in such a way that the steps of the method according to the invention according to one of claims 1 to 5 or that a conventional control or regulating device is reprogrammed to a control or regulating device (150) according to one of claims 6 to 8.

15. Computer program product with a program code stored on a machine-readable carrier for causing the steps of the method according to the invention according to one of claims 1 to 5, when the computer program product is in a control or Control device expires or to cause a conventional control or regulating device to be reprogrammed into a control or regulating device (150) according to one of claims 6 to 8.

16. Computer program with a program code to initiate the steps of the method according to the invention according to one of claims 1 to 15, when the computer program runs on a control or regulating device or to initiate that a conventional control or

Control device to a control or

Control device (150) according to one of claims 6 to 8 is reprogrammed.