EP4297817A1

EP4297817A1 - Method for analyzing a measured pressure value, and devices

Info

Publication number: EP4297817A1
Application number: EP22708895.2A
Authority: EP
Inventors: Pascal Kopperschmidt
Original assignee: Fresenius Medical Care Deutschland GmbH
Current assignee: Fresenius Medical Care Deutschland GmbH
Priority date: 2021-02-26
Filing date: 2022-02-23
Publication date: 2024-01-03
Also published as: WO2022180086A1; US20240139396A1; JP2024507968A; DE102021104683A1; CA3210953A1; AU2022224984A1; CN116887874A

Abstract

The present invention relates to a method for analyzing a measured pressure value, including providing a blood treatment apparatus (100), connectible to a blood tube set (300) that has an arterial blood-conducting line (301) and a venous blood-conducting line (305), the blood treatment apparatus (100) further comprising a blood pump (101), pressure gauge (PS1, PS3) for measuring the pressure in the blood-conducting lines (301, 305), while establishing at least one measured pressure value (Pax, Pvx) in each line, an alarm emitting device (500) for emitting an alarm on the basis of the measured pressure value (Pax, Pvx), and a controller (150) for open-loop or closed-loop control of the blood pump (101). The invention further comprises the step of providing an alarm criterion memory (550) for defining what is an event triggering an alarm, and of providing a reference data memory (555). The method further comprises analysis steps, such as measuring prevailing pressures, analyzing the established measured pressure values using alarm criteria, and repeating pressure measurement steps at certain delivery rates of the blood pump (101) in order to analyze, on the basis of the reference data memory, whether there is a false alarm. The method optionally comprises the step of emitting the alarm. The present invention also relates to devices for initiating or carrying out the method. (Fig. 3)

Description

description

Method for evaluating a measured pressure value, and

fixtures

The present invention relates to a method according to claim 1, a control device according to claim 11, a blood treatment device according to claim 12, also a digital storage medium according to claim 14, a computer program product according to claim 15 or according to the preambles or generic terms of these claims, and a computer program.

Alarms, particularly pressure alarms, are issued regularly when a - e.g. B. in the extracorporeal blood circuit during a blood treatment session of a patient carried out by means of a blood treatment device, for example hemodialysis - a measured pressure value obtained by means of pressure measurement deviates from a stored reference pressure value, exceeds it, falls short of it, etc.

These alarms are accompanied by an alarm signal, in particular an acoustic and/or visual alarm signal for the caregiver of the patient being treated and/or can also lead to a mostly temporary interruption of the treatment session.

In conventional blood treatment devices, for example, the pressures in the blood lines between the blood treatment device and the patient's vascular access are monitored. If an alarm is triggered, the user is asked to rectify the cause of the alarm, to acknowledge the alarm and, if necessary, to arrange for treatment to be continued.

In clinical practice, these measures in the event of an alarm require a lot of personnel and represent a hygienic risk of possible cross-contamination among patients and/or staff.

The pressure fluctuations that lead to alarms are often not critical, since they are caused either by a brief kinking of the blood circulation (alternatively: blood tubing set) or by repositioning or movements of the patient or therapy-related hemodynamic fluctuations.

An object of the present invention can therefore be to propose a method for evaluating a measured pressure value. Suitable devices should also be specified.

The object according to the invention can be achieved by the method with the features of claim 1. It can also be solved by means of the control device having the features of claim 11, the blood treatment device having the features of claim 12, the digital storage medium having the features of claim 14, the computer program product having the features of claim 15 and the computer program as described herein .

According to the invention, a method for evaluating a measured pressure value is thus proposed. The method runs on a provided blood treatment device or includes providing it, which can be connected to a blood tubing set of an extracorporeal blood circuit. Such a blood tubing set has an arterial blood line and a venous blood line.

The provided or to be provided

Blood treatment device has a blood pump, by means of which extracorporeal blood is conveyed along the arterial blood line when in use or as intended. The blood treatment device also has a pressure gauge or sensor for measuring the pressure in the arterial blood line and/or a pressure gauge or sensor for measuring the pressure in the venous blood line. They serve as intended for measuring at least one measured pressure value prevailing and/or determined in the arterial blood line or in the venous blood line.

In addition, an alarm output device for outputting an alarm or pressure alarm based on the measured pressure value determined or its level, preferably when an alarm occurs, is included in the blood treatment device or is connected to it or its pressure gauges. Furthermore, the blood treatment device has a control device for controlling or regulating the blood pump and possibly other components of the blood treatment device.

The method further includes providing an alarm criterion memory for storing at least one predetermined alarm criterion which indicates an alarm event defined, or using them.

The alarm criterion memory can be stored in the sensor, alternatively in an evaluation device, in the control device, it can be part of the programming, etc. The at least one alarm criterion can have been determined and stored beforehand. Alarm criteria can be or include, in particular, threshold values, fluctuation ranges of the measured pressure, the occurrence of pressure fluctuations over time, the occurrence of pressure patterns, etc.

The method further includes the provision of a reference data memory, or its use, which has at least one data set, which in turn contains one or more reference pressure curves,

May contain reference pressure ranges or reference pressure values. The reference data memory can optionally be part of the blood treatment device. The storage device may be or may include any embodiment of a storage device set forth herein.

The method according to the invention further comprises the following steps a) to f), which are referred to herein as evaluation steps, some of which are optional: arterial pressure and/or the pressure prevailing in the venous blood line by means of the corresponding arterial or venous pressure gauge, as a result of which a measured pressure value is determined. A measured pressure reading (e.g. in units of mm/Hg, mbar, or the like) can, for example, be a pressure measured directly in the corresponding line, alternatively the result of a determination of this pressure via auxiliary measurements or observations, conversions and the like. b) Evaluation of the pressure measurement value thus obtained using the alarm criterion stored in the alarm criterion memory. As already discussed above, the alarm criterion can be or include, for example, exceeding or falling below a limit value and/or leaving a limit range. It can depend on technical parameters such as the flow rate of a pump or the like. The evaluation includes determining whether the measured pressure value satisfies the alarm criterion or whether it fulfills an alarm criterion, and an alarm is therefore present. If it does not meet the alarm criterion or does not fulfill it, there is no alarm - at least based on the alarm criterion on which it is based. c) Controlling the blood pump in such a way that it delivers along the arterial blood line at one or more delivery rates referred to herein as reference delivery rates or applies the power required for this. According to the invention, however, this control or actuation of the blood pump only takes place if the measured pressure value satisfies the alarm criterion. The reference delivery rate, or at least one of the reference delivery rates, is lower than the initial delivery rate. The blood pump is thus controlled in order to deliver at a lower delivery rate, referred to herein as the reference delivery rate, than before after a positive determination that the measured pressure value satisfies the alarm criterion and an alarm is therefore present. d) measuring the pressure prevailing in the arterial and/or venous blood line at the one or more reference delivery rates of the blood pump by means of the corresponding pressure gauge. Here, at least one measured pressure value referred to herein as an evaluation pressure measured value is determined. Optionally, one or more arterial and/or one or more venous evaluation pressure measurement values can be collected. After the application of mathematical methods, the evaluation pressure measurement value(s) can represent one or more profiles or be or include one or more reference pressure profiles. e) Evaluation of the at least one evaluation pressure measured value using or by means of a comparison with the data set(s) stored in the reference data memory, with at least one evaluation result being determined. The evaluation result can e.g. B. be a signal. f) outputting an alarm by means of the alarm output device only if the evaluation result satisfies predetermined requirements for outputting an alarm.

For an alarm to be issued, both the alarm criterion (see above) must be met and the evaluation result (see steps e) and f)) must indicate that an alarm has occurred.

In some embodiments, the outputting of an alarm can be or include the outputting of a message which specifically refers to the evaluation result. Furthermore, the present invention relates to a control device. The control device is configured to carry out or cause the evaluation steps of the method according to the invention and/or further steps as disclosed herein, in any combination, in cooperation with a provided blood treatment device, an alarm criterion memory and a reference data memory.

The blood treatment device, which is connected to a blood tubing set that has an arterial blood line and a venous blood line, also includes a blood pump for extracorporeally conveying blood along the arterial blood line. It also includes a pressure gauge for measuring the pressure in the arterial blood line and/or a pressure gauge for measuring the pressure in the venous blood line, in each case in order to determine at least one arterial or venous pressure measurement value.

The alarm output device is for outputting an alarm or pressure alarm based on the measured pressure value or its level in an alarm event. The control device serves to control or regulate the blood pump.

The alarm criterion memory is suitable and/or provided for storing at least one predetermined alarm criterion, which defines an alarm event, and/or has stored such. The alarm criterion can be set by the manufacturer, by the service technician, by the doctor treating you, and/or was preferably set or stored before the start of the treatment session. The reference data memory contains at least one data record which includes one or more reference pressure profiles, reference pressure ranges or reference pressure values. The reference data can be stored in tabular form and/or as a functional approximation (for example using tools such as spline fit, polynomial fit, etc.).

Interaction can be or include driving, controlling or regulating. Interaction may be or require a signal connection.

If a signal or communication connection between two elements, components, etc. is mentioned here, this can be understood to mean a connection that exists during use. This can also be understood to mean that there is a preparation for such a signal connection (wired, wireless or implemented in some other way), for example by coupling both components, for example by means of pairing, etc.

Pairing is a process that takes place in the context of computer networks to create an initial link between computer units for the purpose of communication. The most well-known example of this is the establishment of a Bluetooth connection, by means of which various devices (e.g. smartphone, headphones) are connected to one another. Pairing is also sometimes referred to as bonding.

The present invention further relates to a blood treatment device. The blood treatment device according to the invention has a blood pump for delivering blood extracorporeally along the arterial blood line.

The blood treatment device also has a pressure gauge for measuring the pressure in the arterial blood line and/or a pressure gauge for measuring the pressure in the venous blood line, which are each suitable and/or provided for determining at least one arterial or venous pressure measurement value.

The blood treatment device also has an alarm output device. The alarm output device is for outputting an alarm or pressure alarm based on the measured pressure value or its level in an alarm event.

Depending on the embodiment, the alarm can be given acoustically, for example by means of a beep, visually, for example by means of a flashing light or a message, and/or haptically, for example by means of vibration, or in some other way.

The blood treatment device also has an alarm criterion memory, which is used to store at least one predetermined alarm criterion. The alarm criterion is intended to define an alarm event as set forth herein.

The blood treatment device also has a reference data memory. This contains at least one data set which includes or consists of one or more reference pressure profiles, reference pressure ranges and/or reference pressure values. The blood treatment device also has a control device according to the invention.

Alternatively, the blood treatment device is connected to the aforementioned devices.

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 diskette, memory card, CD, DVD, EPROM, FRAM (ferroelectric RAM), SSD (solid state drive) or NOVRAM, in particular with electronically or optically readable control signals, can be configured in order to configure a conventional control device into a control device according to the invention, with which the steps, in particular the evaluation steps, of the method according to the invention can be initiated.

All, some or some of the steps, in particular the evaluation steps, of this method can be initiated.

A computer program product according to the invention has a program code or a signal wave that is volatile, transient or stored on a machine-readable carrier, by means of which a conventional control device is configured into a control device according to the invention, with which the steps, in particular the evaluation steps, of the method according to the invention are initiated can if the computer program product runs on a computer. All, some or some of the steps, in particular the evaluation steps, of this method can be initiated.

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, run, stored, executed or developed.

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

A computer program according to the invention comprises a program code, by means of which a conventional control device is configured into a control device according to the invention, with which the steps, in particular the evaluation steps, of the method according to the invention can be initiated when the computer program runs on a computer. All, some or some of the steps, in particular the evaluation steps, of this method can be initiated.

According to the invention, a computer program can be understood, for example, as a physical, salable software product which has a program.

Determining or determining, in particular of data and/or values, can include examining the existence or non-existence, obtaining, detecting, measuring, evaluating, processing, comparing, estimating, assessing or estimating, inferring , calculating, achieving, collecting, achieving and/or recognizing.

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

Whenever numerical words are mentioned herein, the person skilled in the art understands them as indicating a numerical lower limit. Provided that this does not lead to a discernible contradiction for the person skilled in the art, the person skilled in the art always reads "at least one" or "at least one" when specifying "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 clearly technically possible for a person skilled in the art. Both are from present invention includes and applies to all numerals used herein.

When “programmed” or “configured” is mentioned here, it is also disclosed that these terms can be exchanged for one another.

Advantageous further developments of the present invention are the subject matter of dependent claims and embodiments.

Where reference is made herein to an embodiment, this represents an exemplary embodiment according to the invention.

If it is disclosed herein that the object according to the invention has one or more features in a specific embodiment, it is also disclosed herein that the object according to the invention expressly does not have this or these features in other embodiments that are also according to the invention, e.g. B. in the sense of a disclaimer. For each embodiment mentioned herein, the contrary embodiment, for example formulated as a negation, is also disclosed.

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

In some embodiments, the method according to the invention comprises stopping the blood pump as a further evaluation step (or step serving the evaluation), then and when the predetermined alarm criterion is met. Such a stopping can take place before the blood pump is controlled to deliver at least one reference delivery rate or a first reference delivery rate. Alternatively, instead of stopping, the delivery rate of the blood pump is lowered, starting from the initial delivery rate to a reference delivery rate below the initial delivery rate.

In some embodiments, the method includes, as a further evaluation step, the alarm output device not outputting an alarm in the event that the measured pressure value satisfies the alarm criterion stored in the alarm criterion memory, but the evaluation result does not meet the predetermined requirements for outputting an alarm.

In this case, any alarm can be omitted, the medical staff cannot be informed, at least acoustically, visually and/or in another way that may be perceived as disturbing, that measured pressure values had meanwhile satisfied the alarm criterion. Alternatively, the medical staff can be informed that pressure readings had meanwhile met the alarm criterion. Such notice may be a communication that does not require human intervention (e.g. by definition, e.g. in the manual).

In some embodiments, the method includes, as a further evaluation step, controlling the blood pump in order to trigger it again, if necessary after a time that the pump needs to start up, using the initial delivery rate or a delivery rate related thereto (e.g. with 90% of the output flow rate) or with a preset one To promote resume funding rate in the event that the evaluation result does not meet the predetermined requirements for issuing an alarm.

In some embodiments, the method includes as further evaluation steps, in particular at the beginning of a blood treatment session, controlling the blood pump to pump blood along the arterial blood line at one or more reference delivery rates, and also measuring the prevailing pressure in the arterial and/or venous blood line the one or more reference delivery rates of the blood pump.

The measurement can be carried out in each case by means of the corresponding pressure gauge in the associated line and is used to determine at least one reference pressure measurement value assigned to a reference delivery rate. A course can be determined or recorded from optionally several measured reference pressure values, in particular a characteristic curve.

In these embodiments, storing at least one data set in the reference data memory is also included in the method as an evaluation step, the data set containing the one or more

Reference pressure reading (e), or contains at least one reference pressure profile created therefrom.

When reference pressure measurement values are mentioned here, this preferably means values that serve as a reference and are themselves measured. If, on the other hand, reference pressure values are mentioned here, this preferably means values which, although they also serve as a reference, do not but necessarily actually measured. You can rather z. B. as rounded values, values averaged over several reference measurements, weighted values or otherwise changed, estimated, adjusted, etc. values that relate directly or indirectly to measured pressure values, but were not themselves collected by means of a pressure sensor. Thus, in some embodiments, the terms "reference pressure readings" measured on the same or different patients and "reference pressure readings" that have been processed in some way may be interchanged.

In some embodiments, the above idea also applies to the term "measured pressure value". This can be measured and used without processing in the method according to the invention. This term "measured pressure value" in the sense of the present invention alternatively relates to pressure values based on measured values differ from the measurement result measured in each case through processing, e.g. B. by averaging, smoothing, etc. An interchangeability of the terms "assessment pressure value" and "assessment pressure measured value" is thus also covered by the present invention.

In some embodiments of the method, the evaluation step of evaluating, by means of which the evaluation result is achieved, is or includes forming a difference between the evaluation pressure measurement value measured by means of the pressure sensor and the one or more reference pressure (measurement) value(s) contained in the data set, the latter being a notation herein that includes both measured as well as non-measured reference pressure values. Alternatively, in some embodiments, the difference between the evaluation pressure measured value measured by the pressure sensor and the reference pressure curve(s) created from the reference pressure (measured) values is/are formed.

In some embodiments, the evaluation to achieve the evaluation result includes or consists of smoothing, in particular using a median filter, of the pressure curve measured using the first pressure sensor and/or the pressure curve measured using the second pressure sensor.

In some embodiments, the evaluation to obtain the evaluation result can include the formation of a

Differential pressure profile between the reference pressure profile and a pressure profile determined for evaluation, based on the evaluation pressure measurement values, be or consist of it.

In some embodiments, the evaluation to obtain the evaluation result is or consists of integrating the differential pressure curve over time.

In some embodiments, a reference pressure curve is determined from reference pressure measurement values, which were measured using the first pressure sensor and/or using the second pressure sensor while the blood pump is pumping the fluid or is being controlled accordingly for pumping.

In some embodiments, pressure sensors are pressure gauges and vice versa. In some embodiments, the measured pressure value and/or reference pressure (measured) value are not pressure amplitudes.

In some embodiments of the blood treatment device according to the invention, the control device is further configured to use an alarm output device, which can be part of the blood treatment device, to issue an alarm in order to prevent a treatment option using the blood treatment device and/or to stop a pump of the blood treatment device, preferably a pump , Which medical liquid, in particular dialysis liquid promotes. According to the present invention, this occurs when the control device ascertains or ascertains that the evaluation result confirms the previously ascertained alarm case.

In some embodiments, the alarm criterion and/or the reference pressure curves, reference pressure ranges or reference intervals can be at the set

Orient treatment option of the blood treatment device or take this into account.

In some embodiments, the blood treatment device according to the invention is configured as a blood purification device or dialysis device for hemodialysis, hemofiltration or hemodiafiltration, as a dialysis device in any other configuration known to those skilled in the art for blood purification, or as a plasmapheresis device.

The blood treatment device is in certain

Embodiments for application for continuous venous hemodiafiltration (CW -HDF) and/or configured for use in acute dialysis or as a critical care device.

In some embodiments, in addition to the comparison of evaluation pressure measurement values recorded in the current treatment with the reference pressure profile recorded at the beginning of the treatment, the reference pressure profile itself can also be evaluated or processed. For this purpose, for example, the reference pressure curve recorded at the beginning of the treatment (or points characterizing this) can be compared with reference pressure curves or values from the history of the patient. The reference pressure curves or values from the history can be or include values recorded over previous treatment(s) of the same patient and/or other patients. In this way, incidents that influence the recorded reference pressure profile can already be recognized at the beginning of the treatment session. Thus, under certain circumstances, a changed, for example shifted, reference pressure profile could indicate problems in connection with the blood treatment. For example, an incorrectly set needle can be recognized by such a comparison of the reference pressure profile.

In some embodiments, individual, several or all devices for executing the method according to the invention, in particular the alarm criterion memory and/or the reference data memory, can be implemented in a cloud.

In these embodiments, the memory contents can advantageously be called up from a number of blood treatment devices provided for the purpose of processing, and (alarm) outputs can be sent to different terminals, e.g. B. Smartphones of the treating staff. In certain embodiments, the

Blood treatment device connected to an extracorporeal blood circuit and / or a blood tubing set.

In some embodiments, a reference pressure curve is a sequence of at least 3, 5, 30, 50 or more measurements, or a sequence of measurements at 3, 5, 30, 50 or more points in time. The points in time can be within a maximum time period of 3, 5, 10, 15, 20 or more seconds.

In some embodiments, the blood pump is controlled to measure the reference pressure reading(s) and store them at the beginning of a treatment session.

In some embodiments, the

Reference pressure readings are determined for the pressures prevailing both in the arterial and in the venous blood line. The evaluation is carried out using, in particular after a statistical evaluation, the sum and/or the mean value of the pressures prevailing in the arterial and venous blood line. Used for the evaluation, e.g. B. by comparing, a corresponding reference pressure (measured) value, which was also determined when evaluating the pressure prevailing in the arterial and venous blood line, in particular after a statistical evaluation, by forming the sum and/or the mean value.

In some embodiments, the determined reference pressure measurement values are compared with at least one data set from at least one past treatment session for the same patient and/or from past treatment sessions reference pressure (measured) values recorded by other patients are compared.

In some embodiments, the determined reference pressure measurement values are used as reference pressure measurement values for the treatment, preferably if and only if the comparison with data sets from or from previous treatment sessions satisfies predetermined criteria, in particular expected values or ranges obtained from the data sets.

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

An advantage of the present invention may be that pressure readings occurring intratherapeutically, which would conventionally suffice to trigger a pressure alarm, are first subjected to an evaluation using the present invention, which is why objectively uncritical pressure readings do not already lead to an alarm, which medical staff attention, time and requires effort. According to the invention, it can thus be possible to automatically recognize as such one or the other supposed alarm situation which, on closer inspection, does not indicate a state that would require an intervention. Since it can be recognized automatically, personnel costs can also be reduced, material resources (keyword changing gloves while treating a first patient and eliminating an - supposed - alarm condition in a second patient) saved and, moreover, hygienic risks, as explained below, can be minimized. Furthermore, the alarm range or the alarm criteria can be set comparatively narrower and/or patient-specifically by means of the individual consideration of measured pressure values that are per se suspect of an alarm and/or due to the evaluation of such measured pressure values supplemented according to the invention. This setting is possible because reference pressure (measured) values or reference characteristic curves are recorded at the beginning of the treatment. Through this targeted recording of the current reference pressure (measured) values, or reference characteristics, patient-specific and dependent on the patient's condition are thus recorded and taken into account. These can lead to customized alarm criteria, which is also encompassed by the present invention.

Possible framework conditions that lead to different reference pressure (measured) values or reference characteristic curves include the size of the needle used, the type of fistula and in particular the blood viscosity of the patient, especially at the beginning of the blood treatment session.

The system's evaluation of the alarm on the basis of combinatorial methods of sensor analysis advantageously increases safety for the patient, since the risk of misinterpretation of alarms is reduced.

Another advantage of the present invention may be that avoiding unnecessary alarms on the blood treatment device increases its user-friendliness. Ease of use increases when false alarms can be suppressed. Since the condition of a patient can advantageously be specifically checked by means of the present invention, the patient's safety can be increased.

Another advantage can be that by avoiding frequent and/or unnecessary alarms, frequent and/or unnecessary touches of the

Blood treatment device are avoided by the treating staff. A reduction in human-machine contacts advantageously leads to better hygiene and the avoidance of contamination among the actors in clinical routine, which also indirectly increases patient safety. In this context, the use of disposable gloves, in particular for acknowledging alarms, can advantageously be reduced and further costs saved as a result.

The cases managed by means of the present invention, in which supposed alarm states are recognized as such and are not brought to the attention of the medical staff, or are not brought to their attention without comment, advantageously significantly reduce the interaction of the medical staff in the case of an uncritical pressure pattern. It is estimated that the self-analysis of pressure alarms reduces the tactile interruption of treatment by about 70%, the treatment appears advantageously calmer, especially for the patient. If the 'tactile' alarm frequency is reduced, the perceived relevance of the now remaining visible alarms becomes significantly higher. The user can read a message text and react to it appropriately.

Another advantage of the present invention can be that the safe clarification of abnormal Abnormalities by means of the present invention, preferably avoiding any audio-visual alarm output where this is not required, helps to counteract the so-called 'alarm fatigue'. 'Alarm fatigue' is the lack of attention paid to alarms due to the frequency with which they occur. The hazard risk associated with 'alarm fatigue' was listed by the Emergency Care Research Institute (ECRI) in the top ten list of technology-related hazards in ICUs and intensive care units in 2008 (https://auriga.com/blog /2020/alarm-fatigue/).

The present invention is easy to implement in existing systems since, according to the invention, devices such as blood pumps, dialysate pumps, pressure gauges or sensors, hose clamps, etc. are regularly already present on conventional blood treatment devices, and the invention can be implemented using them. Retrofitting existing blood treatment devices is also possible in a simple manner by means of software updates.

The present invention is explained below by way of example with reference to the attached drawing, in which identical reference symbols denote the same or similar components. In the figures of the drawing applies:

Fig. 1 shows a schematically simplified one

Fluid line structure of a blood treatment device according to the invention in a first embodiment; 2 shows, in a schematically simplified manner, an evaluation as to whether a determined measured pressure value satisfies an alarm criterion, in an exemplary embodiment;

Fig. 3a shows schematically simplified typical

reference pressure curves as they could be recorded at the beginning of the method according to the invention or were recorded;

FIG. 3b additionally shows the representation of the reference pressure curves from FIG. 3a

evaluation pressure readings B _a x , B _v x for evaluating an alarm event; and

4 shows a greatly simplified representation

Flow chart of a medical method according to the invention in a first embodiment.

1 shows a schematically simplified fluid line structure of a blood treatment device 100 according to the invention in a first, purely exemplary embodiment. Embodiments of the blood treatment device 100 other than that shown herein are also encompassed by the present invention.

The blood treatment device 100 is connected to an extracorporeal blood circuit 300, which can be used for treatment by means of double-needle access, or using z. B. an additional Y-connector (reference symbol Y) as shown in Fig. 1 by means of single-needle access to the vascular system of the not shown patients can be connected. The blood circuit 300 can optionally be present in sections in or on a blood cassette.

Pumps, actuators and/or valves, e.g. B. in the area of blood circulation 300, are connected to the blood treatment device 100 according to the invention or to a control device 150 optionally included therein (which can optionally be a regulating device) in signal communication or connection, or prepared for this.

The blood circuit 300 has an arterial

Patient hose clamp 302 of an arterial section or an arterial patient line, blood sampling line or arterial blood line 301, here connected to an arterial connection needle (or is connected to it). The blood circuit 300 further comprises (or is connected to) a venous patient hose clamp 306 of a venous section, a venous patient line, blood return line or venous blood line 305, here connected to a venous connection needle.

A blood pump 101 is provided in or on the arterial blood line 301, 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 may be fluidly connected to the inflow line 104 . by means of

Substituate pump 111 can substituate by pre-dilution, via a pre-dilution valve 107, or by post-dilution, via a post-dilution valve 109, via associated lines 107a and 109a in line sections, for example in the arterial blood line 301 or in the venous blood line 305 (here between a blood chamber 303b of a blood filter 303 and a venous air separation chamber or venous blood chamber 329) of the blood circuit 300 are introduced.

The blood filter 303 has the blood chamber 303b connected to the arterial blood line 301 and to the venous blood line 305 . One

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 outlet line 102 leading away from the dialysis fluid chamber 303a, which conducts dialysate, ie used dialysis fluid. Suitable connectors on the serve for this purpose

Dialysis liquid inlet line 104 or on the dialysate outlet line 102 on the one hand and on the dialysate ports on the other hand, which can be connected to one another, in particular detachably.

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 liquid or dialysate circuit, which is shown on the left of the membrane 303c in FIG.

The arrangement of FIG. 1 optionally also includes a valve V24, which is arranged in the dialysis liquid supply line 104 upstream of the blood filter 303, but downstream of a pressure sensor PS5. It optionally also includes a valve V25, which is in the dialysate discharge line 102, downstream of the blood filter 303 but upstream of another pressure sensor PS4.

The arrangement of Figure 1 includes an optional detector 315 for detecting air and/or blood. The arrangement of FIG. 1 also includes at least one or more pressure sensors, here the pressure gauges or sensors PSI (here as an example upstream of the blood pump 101) and PS2 (here as an example downstream of the blood pump 101, it measures the pressure upstream of the blood filter 303 (“ 1. A further venous pressure gauge PS3, for example downstream of the venous blood chamber 329, is also provided. Further pressure sensors can be provided. Of the aforementioned pressure gauges PSI and PS3, only one is mandatory provided, the other one as well as the rest can each be provided optionally.

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 is connected to the extracorporeal blood circuit 300 by only one of the two blood lines 301, 305 .

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

An addition point 325 for heparin or another anticoagulant can optionally be provided.

An optional mixing device 163 is shown on the left in FIG providing the respective solution for use by the blood treatment device 100 . The solution contains water from a water source 155 (online, e.g. as reverse osmosis water, or from bags), which e.g. B. in the optional heater 162 is heated.

An optional pump 171, which may be referred to as a concentrate pump or sodium pump, is fluidly connected to and/or pumps from the mixing device 163 and a source of sodium, such as container A.

An optional pump 173 associated with container B, such as for bicarbonate, can also be seen.

A drain 153 for the effluent can also be seen in FIG. 1 . An optional heat exchanger 157 and a first flow pump 159 suitable for degassing complete the arrangement shown.

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

Blood leaving the blood filter 303 flows through an optional venous blood chamber 329, which is a

Have venting device 318 and can be in fluid communication with the pressure sensor PS3.

The exemplary arrangement shown in FIG. 1 has the control device 150, which can be a regulating device. It can be combined with any of the components mentioned here - in any case or in particular with the blood pump 101 - in wired or wireless signal connection for controlling or regulating the blood treatment device 100 are available.

By means of the device for online mixing of the dialysis liquid, the sodium content thereof can be varied within certain limits, controlled by the control device 150 . In particular, the measured values determined by means of conductivity sensors 163a, 163b can be included for this purpose. Should this result in an adjustment of the sodium content of the dialysis fluid

(Sodium concentration) or the substituate as required or desired, this can be done by adjusting the delivery rate of the sodium pump 171.

In addition, the blood treatment device 100 includes means for conveying fresh dialysis fluid and dialysate. So e.g. B. the valve V24 between the first flow pump 159 and the blood filter 303 can be provided, which opens or closes the inlet to the blood filter 303 on the input side. A second, optional flow pump 169 is z. B. provided downstream of the blood filter 303, which promotes dialysate to the drain 153. The valve V25 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 includes 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 area between the first flow pump 159 and the second flow pump 169 . The blood treatment device 100 further comprises means for the exact removal of a volume of liquid specified by the user and/or by the control device 150 from the balanced circuit, such as the ultrafiltration pump 131.

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

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

A leakage sensor 167 is optionally provided. Alternatively, it can also be provided elsewhere.

Other flow pumps, in addition to or as an alternative to e.g. B. that with the reference numeral 169, may also be provided.

A number of optional valves are each labeled V in FIG. Bypass valves are marked with 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.

Filter F1 and F2 can be connected in series. The filter F1 is used here, for example, to produce sufficiently pure dialysis fluid by means of the mixing device 163 itself using impure water, which can then be used, e.g. B. in the countercurrent principle, through the blood filter 303 flows.

The filter F2 is used here, for example, to remove, by filtering z. B. pyrogenic substances to generate sterile or sufficiently filtered substituate, which can safely be fed to the extracorporeal flowing blood of the patient and thus ultimately the patient's body.

At the top right of FIG. 1 are an alarm output device 500, an alarm criteria memory 550, and a

Reference data storage 555 indicated. These devices can be in signal communication or connection with one another and/or with components of the blood treatment device 100, in particular its control device 150, or be prepared for this.

The alarm output device 500 is used to output an alarm or pressure alarm, in particular to the medical staff, based on the measured pressure value P _v x , P _a x currently determined in the arterial blood line 301 and/or the venous blood line 305 (see FIG. 2).

The alarm criterion memory 550 is used to store at least one predetermined alarm criterion AK _a , AK _{V (} see FIG. 2), which defines an alarm event. The reference data memory 555 has at least one data set, which in turn contains one or more reference pressure curves 410, 420 or

contains or has reference pressure (measured) values R _v x , R _a x (see FIG. 3).

The blood treatment device 100 is shown in FIG. 1 as an optional device for hemo(dia)filtration. However, hemodialysis devices, like blood treatment devices that act differently, also fall within the scope of the present invention, although not specifically shown by means of the figure.

The present invention is not limited to the embodiment described above, which is merely illustrative.

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

Fig. 2 shows a schematically simplified evaluation of a measured pressure value P _v 1 , P _v 2 , P _a 1 , P _a 2 measured during a blood treatment session during which the blood pump 101 delivers at an initial delivery rate or is set to it, with regard to whether this corresponds to an alarm criterion AK _V , AK _a is sufficient, ie the latter is fulfilled, in an exemplary embodiment.

In the diagram of FIG. 2, the pressure P is shown over time t. The alarm criteria AK _V , AK _a were used here as an example of reaching, exceeding or falling below certain measured pressure values for the pressure in the arterial blood line 301 or in the venous blood line 305 of the extracorporeal blood tubing set 300 of the blood treatment device 100 is defined. They are stored in the alarm criterion memory 550 (see FIG. 1).

In the example of FIG. 2, the prevailing pressure in the arterial blood line 301 and in the venous blood line 305 is measured at two different points in time t1, t2.

A measured pressure value P _a l in the arterial blood line 301 and a measured pressure value P _V 1 in the venous blood line 305 of the blood tubing set 300 result for the point in time ti. As can be seen in Fig. 2, the measured pressure value P _a l is in the arterial blood line 301 above the alarm criterion AK _a , and the measured pressure value P _V 1 in the venous blood line 305 is below the alarm criterion AK _V . In this example, therefore, no alarm criterion AK _V , AK _a is met. There is therefore no alarm case, no alarm would be issued. Above all, the blood pump 101 (not shown here, see FIG. 1) would not be stopped or its delivery rate would not be reduced according to the invention, as is very well the case below for pressure measurement values other than P _a 1 , P _V 1 is.

A measured pressure value P _a 2 in the arterial blood line 301 and a measured pressure value P _v 2 in the venous blood line 305 of the blood tubing set 300 were measured for the point in time t2. As can be seen from the diagram in FIG. 2, the measured pressure value P _a 2 in the arterial blood line 301 is below the alarm criterion AK _a and the measured pressure value P _v 2 in the venous blood line 305 is above the alarm criterion AK _V . In this example, there would be two alarm criteria AK _V , AK _a - independently of one another Fulfills. In this case, the blood pump 101 would be stopped or its delivery rate would be reduced in order to carry out an assessment of the relevance of the measured pressure values P _a 2 and P _v 2 . This is described in more detail with reference to FIGS. 3 and 4 .

Alternatively or additionally, an evaluation, in particular an averaging or the sum of the arterial pressure measurement value and the venous pressure measurement value, can be compared with an alarm criterion (not shown here).

In particular, a deviation of the sum of the arterial pressure measurement value and the venous pressure measurement value from reference pressure (measurement) values or ranges can indicate the condition and the development of the condition of the fistula, in particular the presence or risk of a stenosis. is e.g. B. the sum of arterial and venous pressure reading z. B. greater than the reference pressure (measured) value, or it is outside the reference pressure range, this can be an indication of a venous stenosis.

An arterial stenosis could be characterized by a low or comparatively low sum of the arterial and venous pressure readings.

A combination of assessments or checks is also possible, so that the sum of the two pressure measurement values mentioned above and one or both individual pressure measurement values are compared with alarm criteria. The alarm criteria can differ depending on the type of measured pressure value. Likewise, the alarm criteria can be formed from a range of measured pressure values with upper and lower limit values. As in the example in FIG. 2, the definition of the alarm criteria AK _V , AK _a can include exceeding or falling below limit values. As an alternative or in addition, boundary areas, in the present example for example the area between AK _V and AK _a , can also be defined, which must not be left. In certain embodiments, limit ranges can be defined in which measured pressure readings must not fall. In the present example, these would be the areas above AK _V and below AK _a . The alarm criteria can be adjusted during treatment.

Fig. 3a shows schematically simplified typical reference pressure curves 410, 420 (e.g. in [mbar] or [hPa] over the delivery rate Q (e.g. in [ml/min])) of the blood pump 101, here in the form of pressure flow -Characteristics as they are recorded at the beginning of the method according to the invention and could be available as a reference during the treatment session.

To create the two reference pressure curves 410, 420, reference pressure measurement values R _v x , R _a x (x=1, x=2, x=3, x=4) (here: pressure-flow pairs) are first determined at the beginning of the treatment by the pressure being determined several times in the blood tubing set 300 - here by way of example both in the arterial blood line 301 and in the venous blood line 305 of the blood tubing set 300 - of the blood treatment device 100, while the blood pump 101 (see Fig. 1) is under one (here: three) promotes different reference funding rates Ql, Q2, Q3. The measured reference pressure values R _v x , R _a x determined for the different reference delivery rates Q1, Q2, Q3 are stored in a suitable reference data memory 555 provided for this purpose stored for retrieval. The ones to create

Reference pressure curves 410, 420 can thus already be present at this point, ie after determining two, three (as in the example in FIG. 3a) or more reference pressure measurement values R _v x , R _a x .

Alternatively or additionally _, continuous or solid curves or characteristic curves can be calculated or recorded from the different reference delivery rates Q1, Q2, Q3 approached by the blood pump 101 and the reference pressure measurement values _Rvx , Rax determined for this purpose. Such are shown in Fig. 3a purely as an option and can serve as reference pressure curves.

In certain embodiments, historical data of the patient to be treated and/or data of a patient collective are used in addition or as an alternative for reference formation.

Alternatively or additionally, the further processing of the determined reference pressure measurement values R _v x , R _a x can result in reference intervals L _a , L _v . These intervals can play a role in later evaluating evaluation print readings and determining evaluation results.

For example, the reference pressure readings R _v x, R _a x at the beginning of the blood treatment session by increasing the delivery rate of the blood pump 101 and repeatedly measuring the pressures prevailing at the individual delivery rates, or by reducing the delivery rate of the blood pump 101 and repeatedly measuring the pressures at the individual production rates prevailing,

Pressures are each determined as reference pressure measurement values R _v x , R _a x . The hysteresis that occurs can itself serve as a reference interval for comparing the evaluation measured values recorded later in the treatment.

The hysteresis curves themselves can serve as a reference interval, for example, by optionally multiplying the curves by a factor. In principle, this factor can assume different values for upper or lower deviations. Alternatively or in addition, the reference pressure readings can be used after equilibrating the pressures at specific blood flow rates. The confidence interval can be formed around these reference pressure measurement values or characteristic curve. The interval can be formed proportionally to the pressure value or as an absolute distance from the reference pressure measurement value. The width of a reference interval can be selected to be constant or variable (depending on the delivery rate).

The acquisition of the reference pressure measurement values R _v x, R _a x at the beginning of the treatment has the advantage that, in comparison to the limit values preset by the manufacturer, the patient-specific conditions of the current treatment, e.g. the size of the needle used, the peculiarities of the fistula and in particular the blood viscosity of the patients can be considered. As a result, more accurate reference pressure measurement values R _v x , R _a x for reference pressure profile 410 , 420 can be achieved. The reference pressure curves 410, 420 can be recorded separately for both the arterial blood line 301 and the venous blood line 305 of the blood tubing set and stored in the reference data memory 555. Processing of the reference pressure measurement values R _v x , R _a x , for example by determining and storing a reference pressure profile from the sum of the respectively associated reference pressure measurement values R _v x , R _a x , is also covered by the present invention. In such embodiments, a total of three or more different

Reference pressure curves/characteristics individually or in any combination for the purpose of evaluating

assessment pressure readings B _v x , B _a x , or their sums are available. In particular, the determined pressure-flow pairs (also: pressure-flow value pairs) or a characteristic curve created from them can be stored. Alternatively or additionally, the parameters of a characteristic curve approximation can be stored. These and other approximations, as mentioned herein, can be done by spline fit, interpolation or polynomial approximation.

In certain embodiments, historical data of the patient to be treated and/or data of a patient population are additionally or alternatively used

plausibility check used. For this purpose, for example, the reference pressure measurement values recorded at the beginning of a treatment session, or reference pressure profiles with stored reference (measurement) pressure values, or

Reference (measured) pressure curves from previous treatment sessions of the same patient are compared. Is there a - e.g. B. measured against predetermined criteria - strong or the predetermined criteria sufficient deviation, that is, a deviation which z. B. exceeds a predetermined limit value, an alarm can already be issued at this point in time. For example, this comparison or review of the reference (measured) pressure values or reference pressure curves an incorrectly set needle can be identified.

In the example of FIG. 3a, the reference pressure curves 410, 420 are shown as solid (characteristic) lines. As explained herein, the reference pressure curves 410, 420 were determined based on reference pressure measurement values R _v x , R _a x (x=1, x=2, x=3) recorded at the beginning of the treatment.

The limits of the optional reference intervals L _v , L _a , which are also determined based on these values, are represented by dotted lines.

Fig. 3b shows the reference pressure curves 410, 420 from FIG. 3a. In FIG. 3b, evaluation pressure measurement values B _a x , B _v x are additionally plotted for evaluating an alarm event.

If a measured pressure value P _v x , P _a x measured during the treatment fulfills at least one alarm criterion, as shown for example in Fig. 2 for the measured pressure values P _v 2 , P _a 2 , the current blood treatment regime is deviated from according to the invention by stopping the blood pump 101 or at least slowed down. While the delivery rate of the blood pump 101 is then gradually increased again, analogous to the determination of the reference pressure measurement values R _v x , R _a x , as was done at the beginning of the treatment and was discussed with reference to FIG. 3a, at different reference delivery rates Qx in each case the pressure currently prevailing in the arterial blood line 301 and/or the venous blood line 305 of the blood tubing set 300 is measured, which is referred to herein as the evaluation pressure measurement value B _v x or B _a x . 3b shows, purely by way of example, six such

Evaluation pressure readings B _v 1, B _v 2, B _v 3, and B _a l, B _a 2, and B _a 3, which were measured at three different reference delivery rates Q1, Q2' and Q3.

Each of the measured evaluation pressure values B _v x or B _a x , each of which can be assigned to a specific reference delivery rate Qx of the blood pump 101 that can be read from Fig. 3a or Fig. 3b, can be used for evaluation, in particular by being compared with the same reference delivery rate Qx associated, reference pressure (measured) value R _v x or R _a x, readable from the reference pressure curves 410, 420, compared or related in some other way.

This relating can, in particular, include forming a difference between the evaluation (measured) pressure value B _v x , B _a x , and the one or more reference (measured) pressure values R _v x , R _a x , in the data set of the reference data memory 555, or with the reference pressure curve(s) 410, 420 created from this.

It can be seen from the example in FIG. 3b that the venous evaluation pressure (measured) value B _V 1 determined under the first reference delivery rate Q1 exactly

Reference pressure (measured) value R _V 1 corresponds. The arterial determined for the same reference delivery rate Ql

Evaluation pressure (measured) value B _a l is still within the reference pressure interval L _a . Up to this point in the ongoing evaluation process, no alarm event would have been confirmed and no alarm triggered.

3b makes it clear that assessment pressure measurement values B _v x or Ba x cannot only be collected for reference delivery rates Qx of blood pump 101 _, for which reference pressure (measurement) values R _v x or R _a x have already been measured beforehand. It Rather, evaluation pressure measured values B _v x or B _a x can also be collected for reference delivery rates Qx, which lie between reference delivery rates Qx for which no reference pressure (measured) values R _v x or R _a x were actually measured, but their reference pressure values based on the reference pressure (measured) values R _v x or R _a x were determined, for example by interpolation.

The latter evaluation pressure measurements include the evaluation pressure measurements B _v 2 and B _a 2. The

Reference delivery rate Q2', at which they are measured, is between Q1 and Q2. The reference pressure values R _v 2 ′ and R _a 2 ′ required for their evaluation can be read from the reference pressure curves 410 , 420 completed to form characteristic curves.

The reference delivery rate Q2′ determined for the evaluation pressure (measured) values B _a 2 , B _v 2 lying between the reference delivery rate Q 1 and the reference delivery rate Q 2 also lie in the respective reference pressure interval L _a , L _v . They would not yet represent confirmation of an alarm case either, ie they would not trigger an alarm.

Of the evaluation pressure measurement values Ba 3, B _v 3 determined in Fig. 3b at the third reference delivery rate Q3, only the venous evaluation pressure measurement value B _v 3 is still in the reference pressure _interval L _v, while the arterial evaluation pressure measurement value B _a 3 is above or outside the reference pressure interval L _a lies.

The evaluation of the evaluation pressure measurement value B _a 3 thus results, with a view to the reference pressure interval L _a , that the predetermined requirements for the issuance of an alarm will suffice. As indicated in FIG. 3b for the evaluation pressure measurement value B _a 3 by means of an alarm icon, a pressure alarm can now be issued. The trigger for this was therefore not one of the pressure values measured during the treatment, as shown in FIG

Assessment pressure reading B _a 3 from the subsequent assessment method according to the invention.

In such a case, the alarm case is therefore confirmed and an alarm to the medical staff would be triggered. In such a case, the medical personnel can then continue with the usual procedures for alarm handling or elimination.

If all evaluation pressure measurement values B _v x , B _a x are within the reference pressure intervals L _v , L _a , the treatment would be continued without confirming the case of an alarm or without (further) triggering an alarm.

In this case, no alarm can be given, the medical staff cannot be informed, at least acoustically, visually and/or in another way that may be perceived as disturbing, that measured pressure values have meanwhile satisfied an alarm criterion, e.g. B. have exceeded or fallen below limit values (cf. FIG. 2). Alternatively, the medical staff can be informed that the measured pressure values have in the meantime satisfied the alarm criterion (cf. FIG. 2). Such an indication can be a notification that the result of the method according to the invention has not resulted in a confirmation of the alarm event. It can be designed in such a way that - unlike actual alarms - no human intervention such. B. Acknowledging, ending or remedying the alarm - requires (e.g. by definition, e.g. as specified in the manual).

Fig. 4 shows a flowchart of the method according to the invention in a first embodiment in a highly simplified representation.

The illustrated method optionally includes the steps of providing a blood treatment device 100, an alarm criterion memory 550 and a

Reference data memory 555, in particular as explained in FIG. 1, ahead. In the following, reference is made to the reference symbols in the previous figures.

Step S1 represents the acquisition of reference pressure (measured) values R _v x, R _a x (pressure-flow pairs) at the beginning of the treatment in the arterial blood line 301 and/or the venous blood line 305, in particular as explained herein in connection with predetermined flow rates of the blood pump 101. It also includes the storage of these reference pressure (measured) values R _v x, R _a x, directly or further processed, for example as

Reference data curves 410, 420 or reference intervals L _a ,

L _v , as data sets in a suitable reference data memory 555 provided for this purpose. In certain specific embodiments, historical data of the patient to be treated and/or data of a patient group are additionally used for reference formation.

The monitoring of the blood treatment is represented by the following steps, during step S2, in particular at regular intervals, in the arterial blood line 301 and/or in the venous blood line 305 the prevailing pressures can be determined as measured pressure values P _v x , P _a x using the pressure gauges PSI and PS3 provided there.

In step S3, the question is answered as to whether the determined measured pressure values P _v x , P _a x are predetermined, im

Alarm criteria AK _a , AK _V stored in the alarm criterion memory 550, which define an alarm event.

If the measured pressure values P _v x , P _a x do not meet an alarm criterion AK _a , AK _{V (} no case), the treatment is continued and a return is made to step S2.

If the measured pressure values P _v x , P _a x meet an alarm criterion AK _a and/or AK _{V (} yes case), the blood pump 101 is stopped in step S4 or alternatively its delivery rate is slowed down such that it is below a predetermined initial delivery rate. In this case, no alarm can be given and the medical staff cannot be informed, at least acoustically, visually and/or in some other way that may be perceived as disturbing, that measured pressure values had in the meantime satisfied the alarm criterion.

Step S5 represents increasing a

Reference delivery rate of the blood pump 101, in particular analogous to the reference delivery rates when determining the

Reference pressure (measured) values R _v x, R _a x before the start of treatment.

In step S6, at the reference delivery rate of the blood pump 101 in the arterial blood line 301 and/or in the venous blood line 305, the respectively prevailing pressure is measured using the corresponding pressure gauge PSI, PS3, and assessment pressure measurement values B _v x , B _a x are thus determined. As long as a critical pressure or the maximum delivery rate of the blood pump 101 has not yet been reached (test in step S7), the determined evaluation pressure measurement values B _v x , B _a x with the reference pressure curves 410, 420 are compared with the reference pressure (mess) in step S9 values R _v x, R _a x and den

Reference intervals L _a , L _v from the reference data store 555 are compared and the question is clarified as to whether the evaluation pressure measurement values B _v x , B _a x remain within the reference intervals L _a , L _v .

If the assessment pressure measurement values B _v x , B _a x are within the reference intervals L _a , L _v , the system returns to step S5 and the delivery rate of the blood pump is further increased according to the method according to the invention.

If the assessment pressure measurement values B _v x , B _a x are outside of the reference intervals L _a , L _v , an acoustic, visual or haptic alarm, in particular a nurse call, in particular for a treating person, is triggered in step S10.

If the check in step S7 shows that a critical pressure or the maximum delivery rate of the blood pump 101 has been reached and that all evaluation pressure measurement values B _v x , B _a x are within the reference pressure intervals L _v , L _a , the treatment is continued (step S10 ).

In this case, there can be no alarm at all, the medical staff cannot be informed, at least acoustically, visually and/or in some other way that may be perceived as disturbing, that measured pressure values in the meantime had met the alarm criterion, because e.g. B. have meanwhile exceeded or fallen below a threshold value (cf. FIG. 2). Alternatively, the medical staff can be informed that pressure readings had meanwhile met the alarm criterion. Such an indication can be a notification that the result of the method according to the invention has not resulted in a confirmation of the alarm event. It can be designed in such a way that it does not require human intervention.

reference character list

100 blood treatment device

101 blood pump

102 Dialysate drain line

104 Dialysis liquid supply line

105 substituate line

107 predilution valve

107 leading to the pre-dilution valve or associated line

109 post dilution valve

109 leading or associated line to the post-dilution valve

111 substituate pump

131 ultrafiltration pump

150 controller

153 drain

155 water source

157 heat exchangers

159 first river pump

161 Device for balancing

162 heater

163 mixing device

163a conductivity sensor

163b conductivity sensor

165a temperature sensor

165b temperature sensor

166 concentrate supply

167 leakage sensor

168 concentrate supply 169 second flow pump 171 pump; sodium pump 173 pump; bicarbonate pump

300 extracorporeal blood circuit

301 arterial blood line

302 (first) hose clamp

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

305 venous blood line

306 (second) hose clamp 315 detector

317 Single Needle Chamber

318 venting device

319 detector 325 addition point for heparin, anticoagulant 329 venous blood chamber (optional)

410 Reference pressure profile in the venous line

420 Reference pressure profile in the arterial line

500 alarm output device

550 alarm criteria memory

555 reference data storage

fl filters

F2 filters

A container for A concentrate; sodium

B container for B concentrate; bicarbonate

AK _a , AK _V alarm criterion

L _a L _v reference interval P pressure measuring points

PSI arterial pressure gauge (optional)

PS2 arterial pressure sensor (optional)

PS3 pressure gauge (optional)

PS4 second pressure sensor to measure the filtrate pressure

(optional)

PS5 pressure sensor for measuring the pressure in the

dialysis liquid supply line

B _a x assessment pressure reading for measurement in the arterial blood line

B _v x Evaluation pressure reading for measurement in the venous blood line

P _a x pressure reading when measuring in the arterial

blood line

P _v x pressure reading when measuring in the venous

blood line

Ql to Q3 reference delivery rates

Q2' reference delivery rate

R _a x reference pressure (measured) value for the measurement in the arterial line

R _v x reference pressure (measured) value for the measurement in the venous line

R _a 2' Reference pressure (measured) value for the measurement in the arterial line

R _v 2' Reference pressure value for the measurement in the arterial line

S1 to S10 method steps

V valves V24 valve

V25 valve

VB bypass valves Y Y connector

Claims

Expectations

1. Method for evaluating a measured pressure value, with the steps:

deploy one

Blood treatment device (100), connectable to a blood tubing set (300), which has an arterial blood line (301) and a venous blood line (305), the blood treatment device (100) having: a blood pump (101) for extracorporeally conveying blood along the arterial blood line (301), a pressure gauge (PSI) for measuring the pressure in the arterial blood line (301) and/or a pressure gauge (PS3) for measuring the pressure in the venous blood line (305), in each case by determining at least one measured pressure value (P _a x, P _v x; xGN), an alarm output device (500) for outputting an alarm based on the measured pressure value (P _a x, P _v x) in the event of an alarm, and a control device (150) for controlling or regulating the blood pump (101) ;

providing an alarm criteria store (550) for storing a predetermined one

Alarm criterion (AK _a , AK _V) , which defines an alarm case; Providing a reference data memory (555) which has at least one data set which contains one or more reference pressure curves (410, 420) or reference pressure (measured) values (R _a x, R _v x; xGN) or reference pressure ranges; the procedure comprising the following assessment steps:

measuring the pressure prevailing at an output delivery rate of the blood pump (101) in the arterial and/or in the venous blood line (301, 305) by means of the corresponding pressure gauge (PSI, PS3) while determining a measured pressure value (P _a x, P _v x);

Evaluation of the measured pressure value (P _a x, P _v x) based on the alarm criterion (AK _a , AK _V) stored in the alarm criterion memory (550), determining whether the measured pressure value (P _a x, P _v x) satisfies the alarm criterion and thus an alarm case exists;

Controlling the blood pump (101) to deliver along the arterial blood line (301) at one or more reference delivery rates (Qx), in the event that the pressure reading (P _a x, P _v x) satisfies the alarm criterion, the

Reference flow rates (Qx), or at least one of the reference flow rates (Qx), is lower than the initial flow rate;

Measuring the pressure prevailing at the one or more reference delivery rates (Qx) of the blood pump (101) in the arterial and/or venous blood line (301, 305) using the corresponding pressure gauge (PSI, PS3) while determining at least one evaluation pressure reading (B _a x, B _v x; x£N);

Evaluation of the at least one evaluation pressure measurement value (B _a x, B _v x) using the data record(s) stored in the reference data memory (555) or by means of a comparison with the determination of at least one evaluation result; and

Outputting an alarm by means of the alarm output device (500) only if the evaluation result satisfies predetermined requirements for outputting an alarm.

2. The method according to claim 1, with the following further evaluation step:

Stopping the blood pump (101), alternatively lowering its delivery rate to a reference delivery rate (Qx), this reference delivery rate (Qx) being below the initial delivery rate if the predetermined alarm criterion (AK _a , AK _V) is met before the blood pump (101) is activated is to promote under the at least one reference delivery rate (Qx).

3. The method according to any one of the preceding claims, with the following further evaluation step: the alarm output device (500) does not output an alarm in the event that the measured pressure value (P _a x, P _v x) although the alarm criterion (AK _a , AK _V ) stored in the alarm criterion memory (500) satisfies, the evaluation result does not meet the predetermined requirements for the outputting of an alarm.

4. The method according to any one of the preceding claims, with the following further evaluation step:

Controlling the blood pump (101) to deliver again using the initial delivery rate or a delivery rate related thereto in the event that the evaluation result does not meet the predetermined requirements for issuing an alarm.

5. The method according to any one of the preceding claims, with the following further evaluation steps:

controlling the blood pump (101) to deliver blood along the arterial blood line (301) at one or more of the reference delivery rates (Qx);

Measuring the pressure prevailing at the one or more reference delivery rates (Qx) of the blood pump (101) in the arterial and/or venous blood line (301, 305) using the corresponding pressure gauge (PSI, PS3) while determining a reference pressure measurement value (R _a x, R _v x);

storing at least one data set in the reference data store (555), the data set containing the one or more

Reference pressure reading(s) (R _a x, R _v x), or contains at least one reference pressure curve (410, 420) created therefrom.

6. The method according to claim 5, wherein the control of the blood pump (101) for measuring and storing the reference pressure measurement value or values (R _a x, R _v x) takes place at the beginning of a treatment session.

7. The method according to any one of the preceding claims, wherein the reference pressure measurement values (R _a x, R _v x) for both the arterial and the venous

Blood line (301, 305) prevailing pressures are determined, and the evaluation using, in particular after a statistical evaluation, the sum and / or the mean value of the arterial and venous blood line (301, 305) prevailing pressures, using a , or by comparison with a corresponding reference pressure (measured) value (R _a x,

R _v x), which is formed when the pressure prevailing in the arterial and venous blood line (301, 305) is evaluated, in particular after a statistical evaluation of the sum and/or the mean value.

8. The method according to any one of the preceding claims, wherein the determined reference pressure measurement values (R _a x, R _v x) are compared with at least one data set from at least one previous treatment session of the same patient and/or from previous treatment sessions of other patients.

9. The method according to claim 8, wherein the determined reference pressure measurement values (R _a x, R _v x) as Reference pressure measurement values (R _a x , R _v x) are used for the treatment if the comparison with data sets of predetermined criteria from or from previous treatment sessions, in particular expected values or ranges obtained from the data sets, is sufficient.

10. The method according to any one of the preceding claims, wherein the evaluation step of evaluating to achieve the evaluation result is or comprises:

Forming a difference between the at least one evaluation pressure measurement value (B _a x, B _v x) measured by means of the pressure gauge (PSI, PS3) and the one or more reference pressure (measurement) value(s) (R _a x) contained in the data set, R _v x), or the one(s) created from the reference pressure readings (R _a x, R _v x).

reference pressure profile(s) (410, 420).

11. Controller (150) configured to cooperate with a provided

Blood treatment device (100) which is connected to a blood tubing set (300) which has an arterial blood line (301) and a venous blood line (305), and which has: a blood pump (101) for extracorporeally pumping blood along the arterial blood line (301), a pressure gauge (PSI) for measuring the pressure in the arterial blood line (301) and/or a pressure gauge (PS3) for measuring the pressure in the venous blood line (305), in each case by determining at least one measured pressure value (P _a x, P _v x )t an alarm output device (500) for outputting an alarm based on the measured pressure value (P _a x, P _v x) in the event of an alarm, and a control device (150) for controlling or regulating the blood pump (101); an alarm criterion memory (550) for storing a predetermined alarm criterion (AK _a , AK _V ) which defines an alarm event; a reference data memory (555) which has at least one data set which contains one or more reference pressure curves (410, 420) or reference pressure values (R _a x, R _v x; xGN) or reference pressure ranges; to perform or cause the assessment steps of any preceding claim.

12. Blood treatment device (100), which has a blood pump (100) for extracorporeally conveying blood along the arterial blood line (301), and a pressure gauge (PSI) for measuring the pressure in the arterial blood line (301) and/or a pressure gauge (PS3) for measuring the pressure in the venous blood line (305), in each case by determining at least one measured pressure value (P _a x, P _v x )t and further comprises or is in signal communication with: an alarm output device (500) for outputting an alarm based on the measured pressure value (P _a x, P _v x) in an alarm event; an alarm criterion memory (550) for storing a predetermined alarm criterion (AK _a , AK _V) which defines an alarm event; a reference data memory (555) which has at least one data set which contains one or more reference pressure curves (410, 420) or reference pressure values (R _a x, R _v x), a control device (150) according to claim 11.

13. Blood treatment device (100) according to claim 12, configured as a blood purification device or dialysis device, for hemodialysis, hemofiltration or hemodiafiltration, or as a plasmapheresis device.

14. Digital storage medium, in particular in the form of a floppy disk, CD or DVD or EPROM, with electronically readable control signals, configured to a control device according to a control device (150). To configure claim 11, by means of which the evaluation steps of the method according to any one of claims 1 to 10 can be caused.

15. Computer program product with a program code stored on a machine-readable carrier in order to configure a control device into a control device (150) according to claim 11, by means of which the evaluation steps of the method according to one of claims 1 to 10 can be initiated.