Method and device for determining when to collect pressure measurements

Abstract

The present invention relates to a method for determining or recommending times (t1, ..., t5) for measuring pressure values ​​of a patient during a blood treatment session. The method involves determining the ultrafiltration rate (UF_rate), relative blood volume (RBV), and / or sodium concentration ([Na + ]), or corresponding values ​​or changes therein, for the presence or fulfillment, in any case, of predetermined criteria for the presence or fulfillment of predetermined criteria for changes therein. The method also includes monitoring the ultrafiltration rate (UF_rate), relative blood volume (RBV), and / or sodium concentration ([Na + ]), or a change therein, if or as soon as predetermined criteria are met, transmitting a signal to the provided blood pressure measuring device (700).

Description

[Technical Field]

[0001] The present invention relates to a method according to claim 1. The present invention also relates to a control device or a closed-loop control device according to claim 6 and to 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. [Background technology]

[0002] Extracorporeal blood treatment using dialysis is known in practice. A patient's blood is extracted and pumped outside the body along a blood circuit, for example, through a hemofilter. The hemofilter comprises a blood chamber through which the blood is guided and a dialysate chamber through which the dialysate is guided. Both chambers are separated from each other by a semipermeable membrane. The blood and the dialysate are guided through the hemofilter largely by the countercurrent principle. The blood is purified in the hemofilter, and upon leaving the hemofilter, the dialysate (hereinafter referred to as effluent or drainage) is considered used and discarded. The discarded drainage includes, in addition to the dialysate, the filtrate (or ultrafiltrate), which contains the water extracted from the blood in the hemofilter. The filtrate and the dialysate, individually and collectively, are hereinafter referred to simply as drainage. Dialysis is primarily used in acute cases as well as in patients with end-stage renal failure.

[0003] Patients with end-stage renal failure are only partially or completely able to eliminate toxins and fluids (water) that accumulate in their bodies. Therefore, these patients rely on extracorporeal dialysis to periodically reduce the accumulation of these substances. For this purpose, most patients typically undergo hemodialysis treatment three times a week. In addition to removing substances such as urea and potassium, the essential purpose of dialysis is to reduce the patient's overhydration caused by fluid intake by removing fluids from the blood, thereby ideally allowing the patient to regain their dry weight after dialysis.

[0004] In the body, water is distributed among different physiological compartments: the intracellular space, the extracellular space, and the interstitium (Guyton & Hall, Textbook of Medical Physiology, Publisher Elsevier Saunders, Philadelphia (USA), 11th Edition, 2006). The distribution of water among these compartments is primarily determined by osmotic equilibrium, which is primarily driven by the sodium content of these compartments. During hemodialysis, both the exchange of substances with blood and the removal of fluid from the blood occur within the dialyzer. After the blood is returned to the body, a new equilibrium is established by the inflow of fluid from other parts of the body and by balancing substance concentrations. However, because these processes take some time, the removal of fluid from the blood by dialysis can sometimes be faster than the inflow of water into the body. This reduces the volume (or amount) of water in the blood vessels, leading to a drop in blood pressure, sometimes severe. Summary of the Invention

[0005] The object of the present invention is to recommend a method for determining the time point for taking a pressure measurement, in particular a blood pressure measurement, during a blood treatment session.

[0006] Furthermore, a control device or closed-loop control device, a medical set, a suitable digital storage medium, a suitable computer program product, and a suitable computer program are specified.

[0007] The object according to the invention can be achieved by a method having the features of claim 1, a control device or closed-loop control device having the features of claim 6, and a medical set having the features of claim 9. Furthermore, the object according to the invention can be achieved by a digital storage medium, a computer program product, and a computer program according to claims 14, 15, and 16.

[0008] The method according to the invention relates to determining or recommending a time point for performing a pressure measurement on a patient, whereby the recommended time point, and indirectly also the measurement time point, is or is during a treatment session, the patient's treatment being one in which the patient's blood is treated extracorporeally using a blood treatment device, in particular by carrying out a process of ultrafiltration.

[0009] The method according to the invention involves determining, during a treatment session or at least one stage thereof, the ultrafiltration rate at which the patient's blood is or will be treated, the patient's relative blood volume, and / or the sodium concentration (hereinafter referred to as [Na +

[0033] . Monitoring may be or may include detecting changes in each of these values ​​over a period of time.

[0010] In particular, these values ​​(ultrafiltration rate, relative blood volume, and / or sodium concentration), or changes therein, are monitored for the presence or fulfilment of predetermined criteria.

[0011] The method according to the present invention further comprises transmitting a signal to the provided blood pressure measuring device if, when, or as soon as predetermined criteria for ultrafiltration rate, relative blood volume, and / or sodium concentration, or changes therein, are met.

[0012] Optionally, the method according to the invention also comprises providing a blood pressure measurement device suitable and / or arranged to collect blood pressure measurement readings of the patient.

[0013] The invention further relates to a control device or closed-loop control device, which is configured or programmed to execute and / or initiate the method according to the invention or its mechanical steps, for example on a provided blood pressure measuring device, in particular in each of the embodiments described herein and in each possible combination of features, in particular method steps, disclosed herein.

[0014] The control device or closed-loop control device may comprise a device capable of performing the individual method steps or method features disclosed in this specification and particularly in the claims, or may be connected in signal communication with such a device suitably designed, configured, and / or programmed for this purpose.

[0015] A medical set according to the invention (also referred to herein as a set) comprises a control device or closed-loop control device according to the invention and a blood pressure measuring device, whereby the control device or closed-loop control device and the blood pressure measuring device are in signal communication with each other.

[0016] In this context, signal communication may encompass the sending and / or receiving or transmitting of information, as well as the exchange of information, or the configuration thereof. In some embodiments, an example of information that a control device or closed-loop control device sends to a blood pressure measurement device is a signal to prepare for a blood pressure measurement, e.g., a signal to inflate a blood pressure cuff. Alternatively or additionally, for example, blood pressure measurements collected by the blood pressure measurement device may be sent from the blood pressure measurement device to the control device or closed-loop control device, e.g., for further processing.

[0017] The digital, in particular non-volatile, storage medium according to the invention is in particular in the form of a machine-readable carrier, in particular a diskette, a storage card, a CD, a DVD, a Blu-ray® disc, or an (E)EPROM, FRAM® (Ferroelectric RAM) or SSD (Solid State Drive) carrying electronically readable control signals, and can be configured to interact with a programmable control device or a closed-loop control device so that in particular the mechanical steps of the method according to the invention are initiated.

[0018] Thereby, all, any or some of the steps of the method according to the invention, in particular the mechanical steps, can be initiated.

[0019] Alternatively or additionally, a digital storage medium according to the present invention may be configured to enable a conventional control device or closed-loop control device to be reprogrammed into a control device or closed-loop control device according to the present invention.

[0020] The computer program product according to the invention comprises a temporary volatile program code or a program code stored on a machine-readable carrier for initiating, in particular mechanical steps of, the method according to the invention when the computer program product is executed on a control device or a closed-loop control device. A computer program product can be understood, for example, according to the invention as a computer program stored on a carrier, an embedded system which is a comprehensive system comprising a computer program (e.g., an electronic device comprising a computer program), a network of computer-implemented computer programs (e.g., a client / server system, a cloud computing system, etc.), or a computer into which a computer program is loaded, operated, stored, executed or developed.

[0021] Alternatively or additionally, a computer program product according to the present invention may be configured to reprogram a conventional control device or closed-loop control device into a control device or closed-loop control device according to the present invention.

[0022] The term "machine-readable carrier" as used herein refers, in certain embodiments of the present invention, to a carrier containing data or information that can be interpreted by software and / or hardware. The carrier may be, for example, a data carrier such as a diskette, CD, DVD, USB stick, flash card, SD card, and any other storage device or medium mentioned herein.

[0023] The computer program according to the invention comprises a program code for initiating the steps, in particular the mechanical steps, of the method according to the invention when the computer program is run on a control device or a closed-loop control device. According to the invention, a computer program can be understood to mean, for example, a physical distributable software product comprising the program.

[0024] Alternatively or additionally, a computer program according to the present invention may be configured to reprogram a conventional control device or closed-loop control device into a control device or closed-loop control device according to the present invention.

[0025] It also applies to the computer program product according to the invention and to the computer program according to the invention, so that all, any or some of the steps, in particular the mechanical steps, of the method according to the invention can be initiated.

[0026] Embodiments according to the invention may comprise some, one or more of the above or following features in any combination, unless a person skilled in the art would recognize such a combination as technically impossible. Embodiments according to the invention are the subject of further dependent claims.

[0027] In all that follows, the use of expressions such as "may be" or "may have" should be understood as synonymous with "preferably is" or "preferably has", respectively, and is intended to exemplify embodiments according to the present invention.

[0028] Whenever numerical terms are used herein, those skilled in the art will recognize or understand them as indicating lower numerical limits. Unless this would lead the skilled artisan to an obvious contradiction, those skilled in the art will understand, for example, a designation of "one" to encompass "at least one." The present invention also equally encompasses this understanding as the interpretation that a numerical term, for example, "one," may alternatively mean "exactly one" whenever this is clearly technically possible for those skilled in the art. Both are encompassed by the present invention and apply to all numerical terms used herein.

[0029] Whenever an embodiment is described herein, it is an exemplary embodiment according to the present invention.

[0030] In some embodiments, the criteria do not include or do not involve determining a time point for measuring the patient's blood pressure.

[0031] In some embodiments, the criteria is not or does not include a predetermined event, time, or time criterion, such as asking whether a predetermined period of time has passed since the previous pressure measurement.

[0032] In some embodiments, the blood pressure measurement device is part of the blood treatment device or is in signal communication with the blood treatment device during a treatment session and / or is configured for and / or is suitably adapted for, assigned to, or "paired" to the blood treatment device.

[0033] In some embodiments, the method does not involve automated blood pressure measurements, for example, taken according to predefined time criteria (eg, every 5 minutes, etc.).

[0034] In some embodiments, the method does not involve multiple blood pressure measurements where the interval between measurements is determined based on a time measurement or only one time measurement.

[0035] In some embodiments, a blood treatment device according to the present invention includes a sensor inserted upstream and / or downstream of the dialyzer of the blood treatment device to measure electrolyte and / or fluid balance, for example, on the dialysate side or machine side and / or blood side. The sensor can be used to determine sodium concentration as described herein.

[0036] In some embodiments, the blood treatment apparatus comprises a control device or closed-loop control device to be controlled or regulated. The control device or closed-loop control device may be a device according to the invention. The control device or closed-loop control device may be programmed and / or configured to control or regulate the blood treatment device in addition to carrying out or causing the method according to the invention to be carried out in cooperation with other devices, in particular blood pressure measuring devices.

[0037] The control device or closed-loop control device may be configured to send a machine signal that is directed to the blood treatment machine as a control signal based on input from a physician, or alternatively or additionally, may be configured to generate the machine signal based on a stored algorithm, allowing the physician to specify, for example, which treatment profile to use.

[0038] Corresponding input fields, switches, controls, etc. for the physician, optionally provided specifically for this purpose, may comprise part of the control device or closed-loop control device, the display device, and / or the blood treatment apparatus.

[0039] In some embodiments, the control device or closed-loop control device, blood pressure measuring device, set or blood treatment apparatus comprises a device configured to perform the steps of the method according to the invention, which applies to any step disclosed herein.

[0040] In some embodiments, methods according to the present invention are implemented on a machine or computer. User input options may be provided for necessary input. Output or display devices may be provided for displaying the results of the method or treatment instructions.

[0041] In some embodiments of methods according to the present invention, the predetermined criterion for the ultrafiltration rate is met when the ultrafiltration rate or a change therein reaches or exceeds a minimum value.

[0042] A predetermined criterion for ultrafiltration rate is met, in some embodiments, when the ultrafiltration rate or change therein over or between predetermined time periods is an objective or goal.

[0043] Alternatively or additionally, in some embodiments, the predetermined criteria for relative blood volume are met when the relative blood volume or its measured reading reaches or falls below a minimum value and / or when its change (i.e., decrease or increase in value per time) reaches or exceeds a maximum value.

[0044] Additionally or alternatively, in some embodiments of the method, a predetermined criterion for sodium concentration, particularly the sodium concentration of the dialysis fluid or dialysate, is met when the sodium concentration falls below a minimum value or when the change in sodium concentration exceeds a maximum value.

[0045] Additionally or alternatively, a predetermined criterion for the ultrafiltration rate, relative blood volume, and / or sodium concentration, or a change in any of them, is met if a predetermined event for the ultrafiltration rate, relative blood volume, and / or sodium concentration occurs or is reached during the course of a treatment profile for the ultrafiltration rate. The treatment profile is set or will be set on the blood treatment device here. Each point in the treatment profile, represented as a curve over time, can be understood here as an event.

[0046] In some embodiments of the method according to the invention, the signal to the blood pressure measuring device provided is or comprises a signal that serves to prepare or initiate preparation of the blood pressure measuring device for blood pressure measurement, which preparation may in particular be or may comprise inflation of an optional blood pressure cuff of the blood pressure measuring device.

[0047] In some embodiments, the signal to the blood pressure measuring device provided is or includes a signal to measure an arterial blood pressure measurement of the patient, or a venous blood pressure measurement, or to prepare for such a measurement. The signal may trigger such a measurement.

[0048] Based on the blood pressure reading obtained on the one hand, and on the overall circumstances that may have influenced the reading on the other hand, the doctor can diagnose normal blood pressure, hypertension, or, more likely here, hypotension.

[0049] Circumstances that must be considered to make such a diagnosis include, among other things, how the patient's blood pressure readings can be classified compared to those of a population, or whether they have changed over time. This process can be described as an evaluation.

[0050] In some embodiments of the method according to the invention, monitoring the ultrafiltration rate, relative blood volume, and / or sodium concentration is or comprises reading out at least one set treatment parameter or treatment profile, or comprises such reading out, for example, from a control device or a closed-loop control device, which treatment profile may be pre-set and / or selected on the blood treatment device used during the blood treatment session.

[0051] In some embodiments of a control device or closed-loop control device according to the invention, the control device or closed-loop control device is optionally configured to process and / or evaluate arterial and / or venous blood pressure readings.

[0052] Arterial and / or venous blood pressure readings may be processed and / or evaluated to diagnose normal, hypertension, or hypotension.

[0053] In some embodiments of a control device or closed-loop control device according to the invention, the device is optionally configured to trigger an alarm.

[0054] Alternatively or additionally, in some embodiments it is configured to interrupt or terminate ultrafiltration.

[0055] In some embodiments, the control device or closed-loop control device is also additionally or alternatively provided and / or configured to initiate at least one new determination of a blood pressure measurement reading, which determination can be followed by processing and / or evaluation thereof.

[0056] Alternatively or additionally, in some embodiments the control device or closed loop control device is configured to administer a bolus or an online bolus.

[0057] For the administration of the bolus, the following can be applied: For treatment, a sodium concentration of 130-145 mmol / l in the dialysis fluid is set as a starting value (depending on the experience of each patient using Kt / V measurement on the blood treatment device or based on measured or determined blood values). The set Na concentration can usually be adjusted up to 155 mmol / l, especially if a hypotensive state is detected.

[0058] When administering a bolus, the bolus volume (usually substitution fluid, administered, for example, via optional pre- or post-dilution ports or pre- or post-dilution valves) is 30-240 ml, which is usually unbalanced.

[0059] The administration of the bolus may be triggered based on a value determined using the conductivity sensor, and may optionally be adjusted for volume and / or sodium or salt content.

[0060] In some embodiments, a control device or closed-loop control device according to the present invention is optionally provided and / or configured to provide appropriate prompts for the user's attention.

[0061] An alarm, interrupt, termination, redetermination, bolus administration, and / or notification may be provided if evaluation of the arterial and / or venous blood pressure readings indicates that the patient is hypertensive or hypotensive, or that a predetermined range of acceptable blood pressure measurements has been reached or exceeded, or that the arterial and / or venous blood pressure readings have fallen below a predetermined minimum value.

[0062] In some embodiments of the medical set according to the invention, the set further comprises a blood treatment device, which is used in particular for the extracorporeal treatment of a patient's blood by carrying out a process of ultrafiltration.

[0063] In some embodiments of the medical set, the blood treatment device is embodied as a hemodialysis device, a hemofiltration device, or a hemodiafiltration device, in particular as a device for acute or long-term renal replacement therapy, whereby the renal replacement therapy can include continuous therapy or intermittent therapy.

[0064] In some embodiments, the medical set according to the invention comprises sensors, which are optionally arranged and configured to measure the sodium concentration, the measurement being preferably carried out extracorporeally, in particular in the dialysis fluid.

[0065] The control device or closed-loop control device is, in some embodiments, further configured or programmed to control or adjust the blood treatment apparatus based on the results of the method, which may be or may include interrupting or terminating blood treatment or ultrafiltration, reducing or adjusting the ultrafiltration rate, redetermining arterial and / or venous blood pressure measurements, administering a saline bolus, treating based on a modified treatment profile, particularly changing the sodium concentration of the dialysis fluid based on a physician's recommendation, etc.

[0066] Whenever preferences or method steps are mentioned herein, the invention also comprises the corresponding programming or configuration of the preferred devices or parts thereof according to the invention.

[0067] Relative blood volume must be determined periodically to control fluid removal in the treated patient. As a result of ultrafiltration, blood volume, and therefore relative blood volume, decreases. Changes in blood volume have a significant impact on the patient's blood pressure during dialysis (Drukker, Parsons and Maher, Replacement of Renal Function by Dialysis, Kluwer Academic Publishers, Dordrecht, 5th Edition, 2004). Relative blood volume (abbreviated as RBV) can be determined, for example, based on hematocrit measurements.

number

[0068] To determine the relative blood volume, different physical methods can be used, for example, measuring electrical conductivity, optical density, blood viscosity, or physical density, in particular by measuring the speed of sound and / or acoustic propagation. According to the present invention, a device, for example, a sensor, is provided for determining and / or monitoring the relative blood volume. Reference is now made to the prior art. Such a device is also referred to herein as a blood volume monitor. According to the present invention, such a blood volume monitor can be provided.

[0069] Some or all of the embodiments of the present invention may have one, some, or all of the advantages listed above and / or below.

[0070] An advantage of the present invention may be improved patient monitoring during a blood treatment session, as patient monitoring occurs specifically during critical moments of the blood treatment session.

[0071] The present invention advantageously avoids patients coming out of a blood treatment session with excess fluid due to a mistakenly deemed necessary reduction in ultrafiltration rate or administration of a non-blood pressure related saline bolus during the treatment session, thus indirectly increasing the patient's tolerance to the blood treatment session and thereby significantly improving the patient's quality of life.

[0072] Use of the present invention advantageously avoids unnecessary stress on personnel, particularly by automating the determination of appropriate variable time points and with the associated benefits of early detection of pressure changes during a patient's blood treatment session without personnel intervention.

[0073] An added benefit is that it saves attention and time on the part of personnel at this point.

[0074] The invention advantageously allows for higher ultrafiltration volumes or rates to be sought without risking discomfort to the patient, and allows for early detection and therefore ultimately advantageous avoidance of moments that may cause discomfort due to too high an ultrafiltration volume or rate.

[0075] A further advantage of the present invention is that it is easy to implement.

[0076] In practice, the current relative blood volume or its rate of change is periodically compared with a threshold value individually defined for each patient, and the fluid withdrawal rate is reduced when the threshold value is exceeded. This can lead to the amount of fluid withdrawn at the end of dialysis being less than the planned amount, and therefore not reaching dry weight. The present invention advantageously avoids these situations, for example, by applying the ultrafiltration rate necessary to achieve dry weight within the available time. If any discomfort occurs, the present invention can recognize this. In this way, it is not necessary to simply preventively reduce the ultrafiltration rate to avoid discomfort on the part of the patient.

[0077] All advantages achievable with the method according to the invention can also be fully achieved with the device according to the invention, and vice versa.

[0078] The present invention will now be described, by way of example only, with reference to the accompanying drawings, in which like reference numerals refer to the same or similar elements. [Brief explanation of the drawings]

[0079] [Figure 1]1 shows a simplified schematic diagram of a blood treatment device according to the present invention having a first embodiment of an extracorporeal blood circuit, or a flow diagram of a blood treatment device according to the present invention, exemplarily embodied as a hemodiafiltration device; [Figure 2] An example of implementation of the method according to the invention is illustrated with reference to a graphical representation of an exemplary treatment profile. [Figure 3a] 1 shows a first alternative treatment profile for blood treatment using ultrafiltration. [Figure 3b] 1 shows a second alternative treatment profile for blood treatment using ultrafiltration. [Figure 4] 1 shows a graphical representation of an exemplary treatment profile adapted according to a method according to the present invention, an example for determining time points (t1, . . . , t5) during blood treatment using ultrafiltration. [Figure 5] An example of implementation of the method according to the invention will now be illustrated with reference to further exemplary graphical representations of treatment profiles. DETAILED DESCRIPTION OF THE INVENTION

[0080] Figure 1 shows an extracorporeal blood circuit 300 that can be connected to the vascular system of a patient (not shown) for treatment via double-needle access or via single-needle access using, for example, an additional Y-connector (reference number Y) as shown in Figure 1. The blood circuit 300 can optionally be in the section or on a blood cassette.

[0081] The pumps, actuators and / or valves in the region of the blood circuit 300 are connected to the blood treatment apparatus 100 according to the invention or to a control device 150 included therein, for example.

[0082] The blood circuit 300 includes (or is connected to) a patient arterial tubing clamp 302 and an arterial connection needle of the arterial section or of the patient arterial line, blood withdrawal line, or first line 301. The blood circuit 300 further includes (or is connected to) a patient venous tubing clamp 306 and a venous connection needle of the venous section, the patient venous line, blood return line, or second line 305.

[0083] A blood pump 101 is provided in or on the first line 301, and a substitution fluid pump 111 is connected to a dialysis fluid inlet line 104 for delivering fresh dialysis fluid (substitution fluid) that is filtered through a further filter (F2). A substitution fluid line 105 can be in fluid communication with the inlet line 104. Using the substitution fluid pump 101, substitution fluid can be introduced into a line section, for example, into the arterial line section 301 or the venous line section 305 of the blood circuit 300 (here, between the blood chamber 303b of the blood filter 303 and the venous air separation chamber or venous blood chamber 29), via the corresponding line 107a or 109a, by predilution via a predilution valve 107 or by postdilution via a postdilution valve 109.

[0084] Hemofilter 303 includes a blood chamber 303b connected to arterial line portion 301 and venous line portion 305. Dialysis fluid chamber 303a of hemofilter 303 is connected to dialysate inlet line 104 leading to chamber 303a and to dialysate outlet line 102 leading away from chamber 303a, which conducts dialysate, i.e., spent dialysis fluid. Dialysis fluid chamber 303a and blood chamber 303b are separated by a semipermeable membrane 303c. This membrane separates the blood side, which contains the extracorporeal blood circuit 300, from the machine side, which contains the dialysis fluid or dialysate circuit, shown to the left of membrane 303c in FIG. 1 .

[0085] The arrangement of Fig. 1 includes an optional detector 315 for detecting air and / or blood. The arrangement of Fig. 1 further includes one or two pressure sensors PS1 (upstream of the blood pump 101) and PS2 (downstream of the blood pump 101) (measuring the pressure upstream of the blood filter 303 ("pre-hemofilter")) in the locations shown in Fig. 1. Additional pressure sensors may be provided, for example, pressure sensor PS3 downstream of the venous blood chamber 29.

[0086] In FIG. 1, an optional single-needle chamber 317 is used as a buffer and / or compensation reservoir in a single-needle approach where the patient is connected to the extracorporeal blood circuit 300 via only one of the two blood lines 301, 305.

[0087] The arrangement of Figure 1 further comprises an optional detector 319 for detecting air bubbles and / or blood.

[0088] A heparin addition point 25 may optionally be provided.

[0089] 1 shows a mixing device 63 that supplies a predetermined mixture of the respective solutions used by the blood treatment device 100 from container A (for A concentrate, via concentrate supply 67) and container B (for B concentrate, via concentrate supply 69). The solutions include hot water from water source 55 (online, e.g., as reverse osmosis water, or from a bag), for example, in heater 61.

[0090] Pump 71, sometimes referred to as a concentrate pump or sodium pump, is in fluid communication with and / or conveys from mixing device 63 and a source having sodium, such as vessel B.

[0091] Furthermore, an outlet 53 for drainage can be seen in Figure 1. An optional heat exchanger 57 and a first flow pump 59 suitable for degassing complete the arrangement shown.

[0092] A further pressure sensor for measuring the filtrate pressure or membrane pressure of the hemofilter 303 may be provided as PS4 downstream of the hemofilter 303 on the water side, but preferably upstream of the ultrafiltration pump 131 in the dialysate outlet line 102. A further optional pressure measuring point P may also be provided.

[0093] The blood exits the hemofilter 303 and passes through an optional venous blood chamber 29, which may include a degassing device 31 and / or may be in fluid communication with a further pressure sensor PS3.

[0094] 1 includes a control device or closed-loop control device 150, which may be in wired or wireless signal communication with any of the components mentioned herein, specifically or in particular with blood pump 101, to control or regulate blood treatment apparatus 100. Control device or closed-loop control device 150 is optionally configured to perform the methods described herein, particularly automatically.

[0095] By using a device for online mixing of the dialysis fluid, variations in the sodium content, controlled by the control device 150, are possible within certain limits. For this purpose, measurements determined via the conductivity sensors 163a, 163b may be taken into consideration. If it is necessary or desirable to adjust the sodium content (sodium concentration) of the dialysis fluid or substitution fluid, this can be done by adjusting the delivery speed of the sodium pump 71.

[0096] Furthermore, the blood treatment device 100 comprises means for transporting fresh dialysis fluid and dialysate. For this purpose, a first flow pump 59 is provided upstream of the hemofilter 303, which transports fresh dialysis fluid towards the hemofilter 303. A first valve may be provided between the first flow pump 59 and the hemofilter 303, which opens and closes the inlet of the hemofilter 303 on the inlet side. A second optional flow pump 169 is provided, for example, downstream of the hemofilter 303, which transports the dialysate to the outlet 53. A second valve may be provided between the hemofilter 303 and the second flow pump 169, which opens and closes the outlet on the outlet side.

[0097] Additionally, blood treatment apparatus 100 optionally includes a device 161 for balancing the flow to and from machine-side dialyzer 303. Balancing device 161 is preferably located in the line section between first flow pump 59 and second flow pump 169.

[0098] The blood treatment machine 100 further includes means, such as an ultrafiltration pump 131 , for precisely removing a volume of fluid from the balancing circuit as specified by the user and / or the control device 150 .

[0099] Sensors such as optional conductivity sensors 163 a, 163 b serve to determine conductivity, which in some embodiments is temperature compensated, and fluid flow rates upstream and downstream of the dialyzer 303.

[0100] The temperature sensors 165a, 165b may be provided individually or in groups, and the temperature readings provided thereby may be used in accordance with the present invention to determine temperature compensated conductivity.

[0101] A leak sensor 167 is optionally provided.

[0102] For example, additional flow pumps may be provided in addition to or as an alternative to the one indicated by reference numeral 169 .

[0103] A bank of optional valves are each designated V in Figure 1. Bypass valves are designated VB.

[0104] In some embodiments, the control device 150 determines electrolyte and / or fluid balance based on measurement readings of the optional sensors mentioned above.

[0105] Filters F1 and F2 may be provided in series connection.

[0106] The filter F1 serves here, exemplarily, to produce, via the mixing device 63, a sufficiently pure dialysis liquid even when impure water is used, which then flows through the hemofilter 303, for example according to the countercurrent principle.

[0107] Illustratively, the filter F2 here serves to produce a sterile or sufficiently filtered substitution fluid from the sufficiently pure dialysis fluid leaving the first filter F1, for example by filtering out pyrogens, which substitution fluid can be safely added to the patient's blood flowing outside the body and thus ultimately delivered to the patient's body.

[0108] FIG. 1 shows that the control device 150 of the blood treatment apparatus 100 may be in wired or wireless signal communication with the blood pressure measuring device 700 and / or the blood volume monitor 800, and is configured and prepared for this, for example, through corresponding mutual programming and coordination.

[0109] The optional blood treatment apparatus 100 of the set according to the invention is shown in Figure 1 as a device for hemo(dia)filtration, however, hemodialysis devices are also included within the scope of the invention, even if not specifically shown in the drawings.

[0110] The invention is not limited to the above-described embodiments, which serve as examples only.

[0111] The arrows shown in FIG. 1 generally indicate the direction of flow in FIG.

[0112] FIG. 2 shows an example of time points t1, ..., t5 set in accordance with the present invention within a time sequence of an exemplary treatment profile, with the predetermined ultrafiltration rate UF_rate (e.g., in ml / h) of the treatment profile shown over time t (e.g., in h).

[0113] Such treatment profiles may be stored on the blood treatment device and may be selected by a physician or qualified medical personnel for the treatment of a particular patient.

[0114] The example given shows a treatment profile with alternating distinct changes in lower and higher ultrafiltration rates UF_rate. The parts of the treatment profile with higher ultrafiltration rates can also be called peaks, as they correspond to peaks in ultrafiltration rate UF_rate over the course of the treatment profile over time.

[0115] With knowledge of the stored treatment profile or its predetermined progression, and due to this, the method according to the invention can determine on the spot or in advance at which time points t1, ..., T5 it is considered useful to measure the patient's blood pressure measurement in accordance with the invention. Since particularly high ultrafiltration rates UF_rate are usually poorly tolerated by the (respective) patient, the end of such peaks is appropriate to determine the patient's current state, in particular to enable the determination of the patient's current blood pressure reading. These time points t1, ..., t5 are marked with an "x" in the diagram of FIG. 2.

[0116] Alternatively or additionally, if the course of the treatment profile is known, the duration D of such peaks can be used to determine at least one time point t1, ..., t5. For clarity, the duration D is indicated by a reference number in only one peak in Figure 2.

[0117] When corresponding signals are transmitted to the blood pressure measuring device 700 at such times t1, ..., t5, blood pressure readings may be measured following the method. Processing of the measured blood pressure readings, for example in the control device or closed-loop control device 150 (see FIG. 1), may cause the selection of an alternative treatment profile (see FIGS. 3a and 3b) or a change in the progression of the selected treatment profile (see FIG. 4), so that treatment should preferably continue over the further course of the blood treatment session.

[0118] The number of time points set according to the present invention (here five) is merely exemplary and should not be understood as limiting in any way.

[0119] FIG. 3a shows a first alternative treatment profile for blood treatment using ultrafiltration.

[0120] Blood pressure readings taken at set time points using the method according to the present invention may indicate that the ultrafiltration rate UF_rate of a selected treatment profile (e.g., the alternating treatment profile shown in FIG. 2) is not sufficiently well tolerated by the patient under treatment. A linear progression of the ultrafiltration rate UF_rate is shown here by way of example, which can be used as a first alternative treatment profile if the above criteria are met. As can be readily seen, the ultrafiltration rate UF_rate in this example treatment profile decreases linearly from the beginning to the end of the blood treatment session.

[0121] It can be hypothesized that a decrease in the ultrafiltration rate UF_rate may be more easily tolerated by patients who did not perform well with the treatment profile of FIG.

[0122] FIG. 3b shows a second alternative treatment profile for blood treatment using ultrafiltration.

[0123] As in Figure 3a, in this example, it is assumed that the ultrafiltration rate UF_rate of the selected treatment profile (e.g., the alternating treatment profile of Figure 2) was not sufficiently well tolerated by the patient during treatment. Here, a step-like progression of the ultrafiltration rate UF_rate is described as an example of a second, alternative treatment profile that can be used if the above criteria are met. As can be readily seen, in this example treatment profile during a blood treatment session, the ultrafiltration rate UF_rate illustratively decreases twice, by one level each time, from start to finish.

[0124] Here too, it can be assumed that a reduced ultrafiltration rate UF_rate can be more easily tolerated by the patient under treatment. According to the invention, at the time points marked with "x", which can be determined in particular by the method according to the invention, a signal is again sent to the blood pressure measuring device 700, which can be followed by the determination of further blood pressure readings and their evaluation and / or processing. According to the invention, provision can be made for the ultrafiltration rate UF_rate to be reduced or maintained at these stages depending on the determined blood pressure readings.

[0125] In some embodiments, based on the determination and evaluation or processing of blood pressure measurement readings, consideration may be given to increasing the ultrafiltration rate UF_rate again or returning to a previously used treatment profile.

[0126] FIG. 4 is a graphical representation of an exemplary treatment profile adapted in accordance with the present invention, showing an example for determining time points t1, . . . , t5 during a blood treatment session using ultrafiltration.

[0127] As in FIG. 3a, in this example, it is assumed that the ultrafiltration rate UF_rate of the selected treatment profile (e.g., the alternating treatment profile of FIG. 2) was not tolerated sufficiently well by the patient under treatment. This was detected at a first time point t1. In contrast to the treatment profile of FIG. 2, the treatment profile selected by the physician is appropriately corrected so that the height of the peak of the ultrafiltration rate UF_rate is adjusted, e.g., lowered, based on the blood pressure reading determined at time point t1 in accordance with the present invention. The different heights of the peak of the ultrafiltration rate UF_rate before and after the adjustment of the ultrafiltration rate UF_rate are illustrated in FIG. 4 by two horizontal dotted lines.

[0128] In such an embodiment, if the ultrafiltration rate UF_rate is well tolerated by the patient, i.e., in conjunction with another acceptable blood pressure reading taken later, the ultrafiltration rate UF_rate can be adjusted upward again, as shown in Figure 4 over the course of the treatment profile over time following time points t3 and t4 marked with an "x".

[0129] Figure 5 shows that what has been stated here in the figure description regarding the criteria for the ultrafiltration rate UF_rate is also relevant to the criteria for the relative blood volume RBV or sodium concentration [Na + ] criteria without restriction. The inventions described in the claims of the original application are set forth below. [1] A method for determining or recommending at least one time point (t1, ..., t5) for measuring pressure measurements of a patient during a treatment session in which the patient's blood is treated extracorporeally via a blood treatment device, in particular by performing (the process of) ultrafiltration, comprising: - Ultrafiltration rate (UF_rate), relative blood volume (RBV), and / or sodium concentration ([Na + ]), or in each case for the presence of any predetermined criteria for a change therein or for the fulfillment of said predetermined criteria, during said treatment session or at least one stage thereof, monitoring said ultrafiltration rate (UF_rate) at which said patient's blood is treated, said relative blood volume (RBV), and / or said sodium concentration ([Na + ]), or in each case monitoring said changes in any of them; - the ultrafiltration rate (UF_rate), the relative blood volume (RBV), and / or the sodium concentration ([Na + ]), or respectively, when or as soon as said predetermined criteria for said change therein are met, transmitting a signal to the provided blood pressure measuring device; A method comprising the step of: [2] - The predetermined criterion for the ultrafiltration rate (UF_rate) is met when a minimum value for the ultrafiltration rate (UF_rate) or its change is reached, exceeded, set, or targeted for a predetermined duration (D); and / or - the predetermined criterion for the relative blood volume (RBV) is met when the relative blood volume (RBV) falls below a minimum value (for the RBV) or when the change in the relative blood volume exceeds a maximum value; and / or - the sodium concentration ([Na + The determined criteria for sodium concentration ([Na + ]) falls below a minimum value or exceeds a maximum value for that change, and / or - the ultrafiltration rate (UF_rate), the relative blood volume (RBV), and / or the sodium concentration ([Na + ]), or in each case, the predetermined criteria for said change thereof, may be a change in the ultrafiltration rate (UF_rate), the relative blood volume (RBV), and / or the sodium concentration ([Na + ]) occurs or is reached, [1] The method described in [1]. [3] The method of [1] or [2], wherein the signal to the provided blood pressure measuring device is or comprises a signal to prepare the blood pressure measuring device for a procedure for measuring a blood pressure reading of the patient, in particular for inflation of a blood pressure cuff of the blood pressure measuring device. [4] The method of any one of [1] to [3], wherein the signal to the provided blood pressure measuring device is or comprises a signal for measuring the patient's arterial blood pressure reading or venous blood pressure reading. [5] The ultrafiltration rate (UF_rate), the relative blood volume (RBV), and / or the sodium concentration ([Na + ]) is or comprises reading out at least one treatment parameter or treatment profile set on the blood treatment device used during the blood treatment session. [6] A control device or closed-loop control device configured to perform the mechanical steps of the method according to any one of [1] to [5]. [7] A control device or closed-loop control device according to [6], configured to process and / or evaluate the arterial blood pressure readings and / or the venous blood pressure readings. [8] The control device or closed-loop control device of [7], configured to trigger an alarm, cause the ultrafiltration to be interrupted or terminated, cause another blood pressure measurement to be determined and evaluated, cause an online bolus to be administered, and / or output corresponding information for the user's attention when the evaluation of the arterial blood pressure reading and / or the venous blood pressure reading indicates that the patient's blood pressure has reached a predetermined range or is no longer within the predetermined range. [9] - A control device or a closed-loop control device according to any one of [6] to [8]; - a blood pressure measuring device; Equipped with The control device and the blood pressure measuring device are in signal communication with each other.

[10] The medical set according to [9], further comprising a blood treatment device for said extracorporeal treatment of a patient's blood, in particular by carrying out (the process of) ultrafiltration.

[11] The medical set according to

[10] , wherein the blood treatment device is embodied as a hemodialysis device, a hemofiltration device, or a hemodiafiltration device, in particular a device for acute or long-term renal replacement therapy.

[12] The medical set described in

[11] , wherein the renal replacement therapy comprises continuous therapy or intermittent therapy.

[13] In particular, the sodium concentration of the dialysis fluid or the dialysis solution ([Na + ]), preferably outside the body, and / or the medical set described in any one of [9] to

[12] , having a sensor arranged and configured to measure the relative blood volume (RBV).

[14] A digital storage medium, in particular in the form of a diskette, storage card, CD, DVD, Blu-ray disc or (E)EPROM, having electronically readable control signals adapted to interact with a programmable control device or closed-loop control device so that the steps of the method according to the invention as defined in any one of [1] to [5] are initiated or so that a conventional control device or closed-loop control device is reprogrammed into a control device or closed-loop control device as defined in any one of [6] to [8].

[15] A computer program product having program code stored on a machine-readable carrier, the program code being for initiating the steps of the method according to the invention as defined in any one of [1] to [5] when the computer program product is run on a control device or a closed-loop control device, or for reprogramming a conventional control device or closed-loop control device to a control device or a closed-loop control device as defined in any one of [6] to [8].

[16] A computer program having a program code for initiating the steps of the method according to any one of claims [1] to [5] when the computer program is run on a control device or a closed-loop control device, or for reprogramming a conventional control device or closed-loop control device to a control device or closed-loop control device according to any one of claims [6] to [8]. [Explanation of symbols]

[0130] 25...Heparin addition point (optional) 29...Venous blood chamber (optional) 31... Degassing device 53...Exit 55…Water supply source 57...Heat exchanger 59...First flow pump 61...Heating device 63…Mixing device 67... Concentrate supply 69…Concentrate supply 71...Concentrate pump, sodium pump 100...Blood treatment device 101...Blood pump 102...Dialysate outlet line, drainage inlet line 104...Dialysis fluid inlet line 105...Replacement fluid line 107...Pre-dilution valve 107a...Line 109...Post-dilution valve 109a...line 111... Replacement fluid pump 121...Dialysis fluid pump 131...Dialysis fluid or drainage pump 150...Control device or closed-loop control device 161...Device 163a...Conductivity sensor 163b...Conductivity sensor 165a...Temperature sensor 165b...Temperature sensor 167...Leak sensor 169...Second flow pump 300...Extracorporeal blood circuit 301...First line (arterial line part) 302...First tube clamp 303...Blood filters or dialysis machines 303a...dialysis fluid chamber 303b...Blood chamber 303c…Semi-permeable membrane 305...Second line (intravenous line) 306...(Second) Tube Clamp 315...Detector 317...Single needle chamber 319...Detector 700...Blood pressure measuring device 800...Blood volume monitor F1...Filter F2...Filter A…Container B…Container D...predetermined duration [Na + ]…Sodium concentration P...Pressure measurement point PS1...Arterial pressure sensor (optional) PS2...Arterial pressure sensor (optional) PS3...Pressure sensor (optional) PS4...Pressure sensor for measuring filtrate pressure (optional) RBV: Relative blood volume t1...time UF_rate…Ultrafiltration rate V...valve VB: Bypass valve Y...Y-connector

Claims

1. 1. A method for operating a blood treatment device for determining or recommending at least one time point (t1, . . . , t5) for measuring a pressure measurement of a patient during a treatment session in which the patient's blood is treated extracorporeally via a blood treatment device, in particular by performing (the process of) ultrafiltration, said blood treatment device comprising at least a control device and a blood volume monitor, said blood volume monitor is operative to monitor the ultrafiltration rate (UF_rate), or the sodium concentration ([Na+]), or in each case, the at least one of said changes therein, at which the patient's blood is treated, during said treatment session or at least one stage thereof, for the presence of any predetermined criterion for, or for the fulfillment of, said predetermined criterion for, said at least one of said ultrafiltration rate (UF_rate), or said sodium concentration ([Na+]), or in each case, the changes therein; said control device is operative to send a signal to a provided blood pressure measuring device when or as soon as said predetermined criteria for said ultrafiltration rate (UF_rate) and / or said sodium concentration ([Na+]) or said change thereof, respectively, are met; The method of operation comprises:

2. the predetermined criterion for the ultrafiltration rate (UF_rate) is met when a minimum value for the ultrafiltration rate (UF_rate) or its change is reached, exceeded, set or targeted over a predetermined duration (D); and / or - the sodium concentration ([Na+]), in particular of the dialysis fluid or dialysate The determined criterion is met when the sodium concentration ([Na+]) falls below a minimum value or exceeds a maximum value for its change, and / or the predetermined criteria for the ultrafiltration rate (UF_rate) and / or the sodium concentration ([Na+]), or in each case the change thereof, are fulfilled when a predetermined event for the ultrafiltration rate (UF_rate) and / or the sodium concentration ([Na+]) occurs or is reached in the course of a blood treatment profile set on the blood treatment device, The method of claim 1 .

3. 3. The method of claim 1 or 2, wherein the signal to the provided blood pressure measuring device is or comprises a signal for preparing the blood pressure measuring device for a procedure for measuring a blood pressure reading of the patient, in particular for inflation of a blood pressure cuff of the blood pressure measuring device.

4. A method according to any one of claims 1 to 3, wherein the signal to the provided blood pressure measuring device is or comprises a signal for measuring an arterial or venous blood pressure reading of a patient.

5. An operating method as described in any one of claims 1 to 4, wherein operating the blood volume monitor to monitor the ultrafiltration rate (UF_rate) and / or the sodium concentration ([Na+]) is or comprises operating the blood volume monitor to read out at least one treatment parameter or treatment profile set on the blood treatment device used during the treatment session.

6. A control device or closed-loop control device configured to carry out the mechanical steps of the method according to any one of claims 1 to 5.

7. 7. A control device or closed-loop control device according to claim 6, configured to process and / or evaluate arterial and / or venous blood pressure readings.

8. 8. The control device or closed-loop control device of claim 7, configured to trigger an alarm, cause an interruption or termination of the ultrafiltration, cause another blood pressure measurement to be determined and evaluated, cause an online bolus to be administered, and / or output corresponding information for a user's attention when the evaluation of the arterial blood pressure reading and / or the venous blood pressure reading indicates that the patient's blood pressure has reached a predetermined range or is no longer within the predetermined range.

9. a control device or a closed-loop control device according to any one of claims 6 to 8, a blood pressure measuring device; Equipped with The control device and the blood pressure measuring device are in signal communication with each other.

10. 10. The medical set according to claim 9, further comprising a blood treatment device for extracorporeal treatment of a patient's blood, in particular by carrying out a process of ultrafiltration.

11. 11. The medical set according to claim 10, wherein the blood treatment device is embodied as a hemodialysis device, a hemofiltration device or a hemodiafiltration device, in particular a device for acute or long-term renal replacement therapy.

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

13. In particular, the sodium concentration ([Na+]) of the dialysis fluid or the dialysis solution is preferably A medical set according to any one of claims 9 to 12, directly or indirectly relying on claim 2, comprising a sensor arranged and configured to measure outside the body.

14. A digital storage medium, in particular in the form of a diskette, storage card, CD, DVD, Blu-ray disc or (E)EPROM, having electronically readable control signals adapted to interact with a programmable control device or closed-loop control device so that the steps of the method according to the invention as claimed in any one of claims 1 to 5 are initiated or so that a conventional control device or closed-loop control device is reprogrammed into a control device or closed-loop control device as claimed in any one of claims 6 to 8.

15. 10. A computer program product having program code stored on a machine readable carrier for initiating the steps of the method according to the invention as claimed in any one of claims 1 to 5, or for causing a conventional control device or closed-loop control device to be reprogrammed into a control device or closed-loop control device as claimed in any one of claims 6 to 8, when the computer program product is run on a control device or closed-loop control device.

16. 10. A computer program having a program code for initiating the steps of the method according to the invention as claimed in any one of claims 1 to 5, or for reprogramming a conventional control device or closed-loop control device to a control device or closed-loop control device as claimed in any one of claims 6 to 8, when the computer program is run on a control device or closed-loop control device.

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