EP4292096A1

EP4292096A1 - Vessel-analysis-supported medical system for determining setting values of a blood treatment device

Info

Publication number: EP4292096A1
Application number: EP22706269.2A
Authority: EP
Inventors: Florian Hubert
Original assignee: Fresenius Medical Care Deutschland GmbH
Current assignee: Fresenius Medical Care Deutschland GmbH
Priority date: 2021-02-11
Filing date: 2022-02-10
Publication date: 2023-12-20
Also published as: WO2022171728A1; US20240042110A1; DE102021103209A1; CN116888680A

Abstract

The present invention relates to a medical system (1) for determining setting values of a blood treatment device (100), having a computing device (5) with an input interface (51) for the inputting and/or reading in of results determined by means of a diagnostic device (700) for carrying out a retinal vessel analysis of a patient (P); an output interface (53) for outputting at least one technical parameter value for treating the patient (P) and/or at least one target treatment parameter value for treating the patient (P) by means of the blood treatment device (100), and/or for outputting suggested changes to existing initial settings or specifications for the technical parameter value and/or the target treatment parameter value.

Description

The present invention relates to a medical system according to claim 1, a blood treatment device according to claim 12, a treatment system according to claim 14, and a method according to claim 15; furthermore, it relates to a digital storage medium according to claim 16, a computer program product according to claim 17 and a computer program according to claim 18 or respectively according to the preambles or generic terms of these claims. For the purpose of blood treatment, setting values for variable treatment parameters can be set by a user, e.g. B. the clinic staff to enter, or to adjust existing default settings, so to change. The user of the blood treatment device can usually set or change such setting values manually, for example by means of input interfaces, e.g. B. on a screen (touch screen) or on other interfaces that are suitable for input, make or cause. In order to achieve predetermined treatment goals or specifications such as the renal dose or the ultrafiltration volume during dialysis treatment, it may be necessary to optimize the course of the treatment session that the user, when setting the setting values, which are described here as technical parameter values (such as e.g. pump rates of the involved pumps such as the blood pump or the ultrafiltration pump) or as target treatment parameter values (such as the renal dose or the duration of the treatment session, which are formulated as goals, but at the same time are implemented or pursued by setting technical parameters), a number of individual circumstances and states of the patient are taken into account. They can include the physical condition of the patient or his vital signs. An object of the present invention may consist in proposing a medical system for supporting the user in determining setting values for treatment using a blood treatment device, a blood treatment device which has a medical system according to the invention, and a treatment system and a method. Furthermore, a digital storage medium, a computer program product and a computer program are to be proposed. The object according to the invention can be achieved by a medical system with the features of claim 1. It can also be achieved by a blood treatment device having the features of claim 12, by a treatment system having the features of claim 14 and by a method having the features of claim 15. It can also be achieved by a digital storage medium with the features of claim 16, by a computer program product with the features of claim 17 and by a computer program with the features of claim 18. According to the invention, a medical system (hereinafter also abbreviated to: system ) for establishing setting values (or ranges of values therefor) of a blood treatment device, or in support of the User of the blood treatment device here, proposed, so of values (or ranges for this), which are variable and z. B. by the doctor at the blood treatment device before or during the treatment session on, or with effect on, the blood treatment device could be adjusted. The medical system according to the invention includes a computing device with an input interface. The latter is prepared for manual input or for automatically reading in results that were determined in advance or previously using a diagnostic device (also: examination device) that is designed to carry out a retinal vessel analysis of a patient and are therefore already available. The system further includes an output interface. It is configured to output at least one technical parameter value, alternatively or additionally at least one target treatment parameter value, and/or changes to existing presettings or specifications for the technical parameter value and/or the target treatment parameter value. Technical parameter value and target treatment parameter value each serve, directly or indirectly, to control or regulate the blood treatment device during a treatment session of the patient by means of the same. The computing device is programmed to, based on the results entered or read in by means of the first input interface, for the technical parameter value and/or the target treatment parameter value or for their levels, numerical values or amounts for the To determine control or regulation of the blood treatment device for the treatment of the patient or to assign one in each case. Determining or determining data can be or include examining an existence or non-existence, measuring, inferring, calculating, obtaining, reaching and/or recognizing. Alternatively or additionally, the computing device is programmed to determine or allocate required changes (or their amount, value, amount, etc.) compared to an earlier specification of the technical parameter value or the target treatment parameter value based on the results entered or read in via the first input interface. The previous default can z. B. a default setting that is already set, for example, on the blood treatment device, or a default, z. B. a value previously used for the treatment, an entry in the patient file or history, an instruction from the attending physician, etc. The computing device is further programmed to determine the technical parameter value determined by it and/or the target treatment parameter value determined by it and/or or the respective change determined by it, to be output by means of the output interface. The blood treatment device according to the invention, which is preferably designed as a dialysis device, has a medical system according to the invention or is connected to it in signal connection or communication. The treatment system according to the invention has or consists of one or more blood treatment devices, preferably as disclosed herein, and a medical system according to the invention. At least one blood treatment device is preferably configured as a dialysis device. One, several or all of the blood treatment device(s) of the treatment system on the one hand and the medical system on the other hand are separate from one another. The term “separate from each other” can be used here, e.g. B. include a spatial, physical separation and / or a separation such that there is no signal communication between the blood treatment device and the medical system. Alternatively or additionally, this can mean that one component (eg the medical system) is not part of the other component (eg one of the blood treatment devices). The method according to the invention preferably serves to prepare an upcoming treatment or treatment session for a patient, which is to be carried out using a blood treatment device, and preferably ends before the start of the treatment. Alternatively or additionally, the method according to the invention runs during the treatment session using the blood treatment device. The method comprises the following steps: providing a medical system according to the invention, a blood treatment device according to the invention, a treatment system according to the invention; alternatively, it includes using such medical system, blood treatment device or treatment system already provided; - manually inputting at least one result detected by means of the diagnostic device into the input interface of the computing device; reading at least one technical parameter value and/or at least one target treatment parameter value, or the changes proposed therefor, which is output from or at the output interface for treating the patient using the blood treatment device; and - entering the read technical parameter value and/or target treatment parameter value, or their respective change, as a setting value in an input interface of the blood treatment device. 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, CD, DVD, EPROM, FRAM (ferroelectric RAM), NOVRAM or SSD (solid state drive), in particular with electronic or optically readable control signals, is designed to to interact with a programmable computer system in such a way that a conventional computing device is reprogrammed into a computing device of a medical system according to the invention, e.g. B. when its memory content expires on the programmable computer system. A computer program product according to the invention has a program code or signal wave that is volatile, transient or stored on a machine-readable carrier, configured to interact with a programmable computer configuration of a computer system in such a way that a conventional computing device is reprogrammed into a computing device of a medical system according to the invention. According to the invention, a computer program product can mean, for example, a computer program stored on a carrier, an embedded system as a comprehensive system with a computer program (e.g. an electronic device with a computer program), a network of computer-implemented computer programs (e.g. a client/ server system, a cloud computing system, etc.) or a computer on which a computer program is loaded, running, stored, executed or developed. The term "machine-readable medium" as used herein means, in certain embodiments of the present invention, a medium containing data or information interpretable by software and/or hardware. The carrier can be a data carrier such as a floppy disk, a CD, a DVD, a USB stick, a flash card, an SD card and the like, as well as any other memory or storage medium mentioned herein. According to the invention, a computer program product can also be understood to mean a programmed application (in short: app), for example in particular for a smartphone, a tablet or another mobile hand-held device. A computer program according to the invention has a program code to cause a conventional computing device to be reprogrammed into a computing device of a medical system according to the invention when the computer program runs on a corresponding computer system. According to the invention, a computer program can be understood, for example, as a physical, marketable software product which has a program. In all preceding 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 embodiments according to the invention. Embodiments according to the invention can have one or more of the features mentioned above or below. The features mentioned here can be the subject matter of embodiments according to the invention in any combination, provided the person skilled in the art does not recognize a concrete combination as technically impossible. Embodiments according to the invention are also the subject matter of the dependent claims. 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 encompassed by the present invention and apply to all numerals used herein. Whenever a suitability or a method step is mentioned herein, the present invention preferably also includes a corresponding programming or configuration of a suitable device or a section thereof, in particular 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. Whenever an embodiment is referred to herein, it is an exemplary embodiment of the invention. Where “programmed” or “configured” is used herein, it is also disclosed to interchange these terms. When "UF" is used herein, it is a common abbreviation for ultrafiltration. Reference herein to "DVA" is a common abbreviation for dynamic retinal vascular analysis. In retinal vessel analysis, a retinal camera (also: fundus camera), the retinal vessel analyzer (see e.g. DE 102004 017 130 B4, DE 102006 018 445 A1, DE 19648 935 B4 and others), measures the diameter of arteries and veins the fundus. In dynamic retinal vessel analysis ("DVA"), a 12.5 Hz optoelectric flicker light is also used to stimulate and the change in vessel diameter is quantified. This test can follow different protocols, for example in the form of three times 20 seconds of flickering light with a wavelength, for example, between 510 nm and 580 nm with e.g. B. 80 seconds of recovery time in between. The examination is usually carried out when the patient's pupils have been dilated by medication; it is completely non-invasive and can provide a statement of a patient's cardiovascular risk profile. In some embodiments, the results from the retinal vessel analysis determined in advance by means of the diagnostic device include, in particular, the venous and/or the arterial dilatation, or are based on these. If, as provided in some embodiments, the maximum diameter of the observed vessel of the fundus or the retinal retinal diameter is divided by its base diameter (also known as "initial value", "resting diameter" or "baseline", see also the following dissertation by Karoline Bornmann). , you get a percentage that can be used as a result. The determined values of the venous and/or arterial dilatation can be displayed as a graphic in certain embodiments. In this way, a long-term history can be presented to the attending physician. Cardioprotective dialysis treatment can be indicated on the basis of increasing values of venous and/or arterial dilatation. In some embodiments of the system, this has a display device. The display device is configured or programmed to display the results from the examination using the diagnostic device. Alternatively or additionally, it is programmed to display the technical parameter value and/or target treatment parameter value determined by means of the system's computing device, or to display the optionally proposed change in each case. In some embodiments, the results are or were assigned to percentiles, tertiles, other classification units, etc., that is to say they are related to the results from measurements taken from a group of patients. A value or range of values for one or more technical parameters and/or for one or more target treatment parameters can be assigned to each percentile, tertile, further classification unit, etc., e.g. B. in data storage, look-up tables, etc. In such data storage, look-up tables, etc., values or value ranges for one or more technical parameters and / or for one or more target treatment parameters can be stored, which using models, algorithms, artificial neural networks, artificial intelligence , the comparison with a group of patients and e.g. B. assigned to their respective results and/or courses from retinal vessel analyzes and/or specified in particular using machine learning. In such data stores, look-up tables, etc., which may be part of the inventive system or treatment system, data may in some embodiments be stored by some persons, e.g. B. medical staff, technicians or others, with or without prior verification of suitability or authorization (such as requesting a password, biometric data, etc.) or, z. B. based on your own experience or after taking note of current research results. The medical system or the treatment system can therefore have an interface for changing the data stored in data stores, look-up tables, etc. In some embodiments, the output interface is or includes an optical, visual, or graphical interface for the user. Alternatively it is connected to a graphical display device such as a monitor or a printer. In some embodiments, the output interface may be configured as a GUI (Graphical User Interface) and/or may be a user interface herein. In some embodiments, the display device is programmed or configured to display values of the technical parameter or the target treatment parameter as described herein. In some embodiments, the output interface is or includes an interface with/to a control or regulation device of a blood treatment device. In some embodiments, the output interface is or includes an interface with a server, a network protocol, and/or a data store. In some embodiments, the medical system according to the invention is or includes a mobile device, hand-held device, mobile phone, smartphone, tablet, etc. Alternatively or additionally, the system is or has an application (abbreviated: app) suitable for this purpose. The Application may be loaded onto, stored on, executed by, or run on a mobile or other device. In some embodiments, the medical system further includes a diagnostic device or examination device for performing a retinal vessel analysis of a patient. This can be designed, for example, as described in one of the aforementioned property rights or applications. Their disclosure in this regard is therefore also made the subject matter of the present disclosure by reference at this point. The diagnostic device can be designed as in the medical dissertation by Karoline Bornmann (“Influence of flicker light on the retinal vessel diameter taking into account the female hormone cycle within one month” from 2014, submitted to the University of Jena). Their relevant disclosure content is also made the subject matter of the present disclosure by reference. The retinal vessel analysis can be carried out statically or dynamically, ie using flickering light, as explained above. In some embodiments of the medical system, the technical parameter values or target treatment parameter values determined by the computing device relate to or include the type of treatment and/or - the volume of ultrafiltration and/or - the duration of treatment and/or - the sodium management (e.g. the amount of sodium to be removed as a target value by dialysis during the treatment session or the concentration of sodium in the patient's blood at the end of the treatment session, for which, for example, it can be determined that it should correspond to the concentration at the beginning of the treatment session; it can correspond to 138 mmol/l, for example) and/or - the fluid management, in particular the delivery rate of the blood pump and/or the delivery rate of the substituate pump or .changes hereof. These values each relate to the current or upcoming treatment session of the patient to be treated. A renal dose can be defined as the quotient of the effluent flow or filtrate flow on the one hand and the patient's weight on the other. Depending on the type of dialysis treatment, different flows (e.g. dialysate flow, dialysis fluid flow, substituate flow, calcium flow, citrate flow, net ultrafiltration) may have to be taken into account when determining the effluent flow. The renal dose can be, for example, the target renal dose (TRD) or the effective renal dose (RRD). The renal target dose (TRD) can e.g. B. can be calculated using the following formula: Fresenius Medical Care Deutschland GmbH Where: BF blood flow or blood flow rate DF dialysis fluid flow or dialysis fluid flow rate NFRF net fluid withdrawal flow or flow rate m patient weight PostDF post-dilution flow or flow rate PreDF pre-dilution flow or flow rate. The effective renal dose (RRD) can be calculated as a function of the treatment duration t using the formula be calculated, where: BV processed blood volume DV dialysis fluid volume NFRV net fluid withdrawal volume m patient weight PostDV post-dilution volume PreDV pre-dilution volume a part of this. Alternatively, the medical system is in signal connection or communication with such. If a signal or communication connection between two components is discussed 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 (wired, wireless or implemented in some other way) signal communication, for example by coupling both components, for example by means of pairing, etc. Pairing is a process that is associated with Computer networks takes place in order to establish 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. In some embodiments, the control or regulating device is programmed to control or regulate the blood treatment device, which has a delivery device for a liquid, in particular an ultrafiltration pump, a blood pump and/or a dialysis liquid pump, using the calculated or determined technical parameter value or target treatment parameter value. In some embodiments, the blood treatment device according to the invention is designed as a hemodialysis device, hemofiltration device or Hemodiafiltration device, in particular as a device for acute, chronic renal replacement therapy or for continuous renal replacement therapy (CRRT=continuous renal replacement therapy). If a preset value is mentioned here, or a default setting, this can be a last set value, a standard value, a displayed value or a default setting. A factory or service engineer specified value herein is optional but not mandatory. In some embodiments, the input interface can optionally be used to change the determined or proposed value of a parameter value and/or a target treatment parameter value by a user, for example by manual manipulation of the input interface or optionally its switches, buttons, buttons, etc. In some embodiments, the computing device connected to the output device and/or to the input interface, preferably in signal communication, or prepared for this. In some embodiments, the input interface may be or include a suitably configured touch screen, rotary switch, slider, keyboard, or the like. In certain specific embodiments, provision can be made for results to be read in automatically at the input interface and for manual input to be permitted. Taking into account the results determined by means of the diagnostic device when determining the target treatment parameter value (or its level) or the technical parameter value (or its level) or their respective change for components of the blood treatment device, for example for the blood pump and/or dialysis fluid pump, can in some embodiments e.g . B. based on known algorithms, which in turn further parameter values, z. B. from auxiliary tables, etc. can include. These algorithms and/or further parameter values (as well as further setting values belonging to the last ones) can be stored in a memory device of the medical system, for example. The technical parameter value or target treatment parameter value, in particular the change thereof, can be actively confirmed or rejected by the user in some embodiments. Suitable input options for this, for example a save or cancel button, can be provided. The confirmation can be a simple actuation of an "OK" button or the like. In some embodiments, confirming does not include typing, inputting, selecting, etc. setting values from a large number of options or even calculating them or silently “nodding” in passing or in the head. The results collected using the diagnostic device, the technical parameter values, target treatment parameter values and/or treatment specification(s) preferably relate to the specific patient being treated at this moment using the blood treatment device or to a specific patient whose blood treatment using the blood treatment device is to take place in the near future future is pending. In some embodiments, the technical parameter values determined by the computing device are or include a setting value for the blood pump and a setting value for the dialysis fluid pump. In other words, the computing device is programmed in these embodiments, the setting value for the blood pump and the setting value for the dialysis fluid pump, which were determined or calculated based on the technical parameter value by taking into account the results of the examination using the diagnostic device, using the display device dem display or otherwise output user as technical parameter values, or as a part thereof, for information. According to the invention, in some embodiments, the medical system according to the invention is implemented in a control or regulating device of a blood treatment device, whereby the blood treatment device is in turn configured into a blood treatment device according to the invention. In these embodiments, existing input and output interfaces and the computing device of the blood treatment device could then be advantageous be used to implement the medical system according to the invention. In some embodiments, the medical system can be or include a server-based solution in which the user can call up a program running on the server, for example via a website, in order to run or initiate the steps of the method according to the invention. The medical system can thus optionally include a server. It can include user interfaces and/or user terminals such as computers, mobile phones or tablets that are set up to communicate with the server. In some embodiments, the computing device of the medical system is programmed in such a way that it is able to record additional (relevant) parameter values for the treatment session using existing or additional input interfaces. Alternatively, further parameters can be read, for example from a storage medium provided for this purpose. Alternatively or additionally, in some embodiments the medical system is programmed to display the further parameter values within existing or further output interfaces. The computing device can advantageously be configured to take these parameter values into account when determining the setting values for the pumps involved in the blood treatment device. In some embodiments, the computing device of the medical system is programmed to use the setting value for the blood pump and the setting value for the dialysis fluid pump of the selected combination display by means of the display device to the user for information. In some embodiments, the output interface and the display device can be identical. An output using the output interface can thus be a display using the display device, and vice versa. The medical system can be programmed to transfer the values determined or assigned by means of the computing device to a logistics system and/or a billing system, for example. The logistic system and/or billing system, which may be external to the medical system according to the invention, but may well be part of the system according to the invention, can in turn be programmed to monitor, record, store, issue, bill, delivery flows, orders, consumption and the like to provide and/or otherwise process. The logistics system can be configured to use values transmitted by the medical system to order liquids used during a treatment session, such as citrate solution, dialysis liquid, etc., and to arrange for delivery to the clinic in which the blood treatment took place. The billing system can be provided to use the values transmitted by the medical system for billing the services provided by the clinic in connection with the treatment session. For example, the changed values of the target treatment parameters or the entry of a treatment specification can reflect the consumption of liquids such as heparin, citrate solution, etc. This can form the basis for billing the patient or be made to a payer such as an insurance company. In some embodiments, the method includes the preferably automatic control or regulation of the blood treatment device based on values that have been changed or entered, as described herein, and technical parameter values and/or target treatment parameter values determined therefrom. In some embodiments, the diagnostic device is provided as a standalone device, e.g. B., provided on a dialysis station. In some embodiments, the diagnostic device is or is connected to a network (e.g. the clinic) and the respective results are transmitted to a server during operation, which stores the results and transmits them to the blood treatment device(s). The treating physician can view the results and set or modify technical parameter values or target treatment parameter values based on these results and using the medical system as disclosed herein. In some embodiments, the diagnostic device is attached to a blood treatment device, e.g. pivoted, e.g. B. by means of one or more ball joints. In the example of a device for retinal vessel analysis as a diagnostic device, for example, the device for retinal vessel analysis can be fixedly mounted on the blood treatment device, while the fundus camera is pivotally mounted by a joint. By means of several ball joints, the camera optimally aligned with the patient's eye fundus. After use, the camera can be pivoted back to the back of the blood treatment device. In some specific embodiments it is provided that the diagnostic device is designed in a manner similar to “VR” glasses. The diagnostic device can be provided in a housing that can accommodate both the fundus camera and the evaluation electronics. This housing can be put on by the patient "like glasses" in order to undergo a measurement. In some embodiments, the results obtained in this way are transmitted to the medical system or the blood treatment device, by cable or wirelessly. In some embodiments, the results obtained from the examination using the diagnostic device preferably influence the ultrafiltration rate (“UF rate” for short) as an example of a technical parameter. Here, for example, depending on the time that has already elapsed since the start of the treatment session (herein also: t ₀ ), the standard curve shape of the UF rate is changed over time based on the results of the examination using the diagnostic device. Different curve shapes are possible, which is described in detail in connection with FIGS. 3 to 5 . In such a case, the adjustment of the technical parameters can serve to withdraw the ultrafiltration volume (alternatively: ultrafiltration amount) in the most cardioprotective way possible by initially determining the UF rate and modifying it as best as possible over the course of the treatment session with a view to the results of the retinal vessel analysis. In some embodiments, the results from the examination using the diagnostic device preferably influence the duration of a blood treatment, the duration being an example of a value of a target treatment parameter. With an unfavorable calcium/phosphate balance, calcification leads to increased stenosis in the vascular system. Excess phosphate can be better broken down by extending the duration of the blood treatment. In some embodiments, the results from the examination using the diagnostic device preferably influence the type of treatment (in particular high volume HDF) as a further example of a target treatment parameter. If this type of treatment is supported by the blood treatment device, based on the above results, for example, a high volume HDF treatment can be activated by entering or specifying “high volume HDF” as a target treatment parameter value or setting using the input interface of the blood treatment device. In some embodiments, the results from the examination using the diagnostic device preferably have an influence on the sodium management. If the blood treatment device supports sodium management with a zero balance, ie the patient's sodium level should be at the same value before and after the treatment, sodium management with a zero balance can be activated on the blood treatment device based on the results of the diagnostic device. In some embodiments, the output interface is additionally designed to output at least one technical parameter value for treating the patient and/or at least one target treatment parameter value for treating the patient using the blood treatment device, in order to output treatment advice. This information can be a cardiological risk for the specific patient as a warning for the doctor, a recommendation, e.g. B. a drug, a substance of a drug group such. B. "prescribe / administer anti-inflammatories" or the like. The computing device can be programmed to create such indications and/or to ascertain them from memory devices with a view to the results of the examination using the diagnostic device. Some or all embodiments according to the invention can have one, several or all of the advantages mentioned above and/or below. Overhydration is common in patients with kidney failure and is closely related to cardiovascular disease, the leading cause of death in dialysis patients. Achieving an optimal fluid balance is therefore one of the central challenges in dialysis routine. One advantage of the present invention can be that the user, ie mostly the treating doctor, can specify optimal parameter values or target treatment parameter values on the blood treatment device used for the forthcoming or current Allow or facilitate treatment session and increase patient safety. Since the retinal vessel analysis can provide non-invasive information about the cardiovascular risk profile of a patient and adjustments to the blood treatment can be derived from this according to the invention, the present invention advantageously enables a suitable adjustment of the technical parameter values or target treatment parameter values for patients who require special protection with regard to their cardiovascular condition . It is thus advantageously possible by means of the present invention to initiate a cardioprotective blood treatment using the blood treatment device, which is individually adapted to the patient to be treated. This indirectly increases the quality of life of the patient and also serves his safety. A further advantage of the present invention can also consist in the fact that the facilitation of finding suitable technical parameter values and target treatment parameter values by means of the invention can also give an inexperienced user more security when making the settings. According to the invention, the probability of error when finding such values can be significantly reduced, for example because mental arithmetic steps or the risk of errors in reasoning by the user can be eliminated. On the other hand, the competence and responsibility for finding or changing the setting values can advantageously remain with the user. The user thus receives valuable support from the medical system according to the invention, but without being able to be surprised by its unauthorized action. If the blood treatment device and medical system remain separate devices, then existing blood treatment devices can be combined with the medical system according to the invention to form the treatment system according to the invention. Since interventions in the control of the blood treatment device are not necessary in this case, there is advantageously no need to re-approve the blood treatment device as a medical device. The present invention is explained below by way of example with reference to the attached drawing, in which the same reference symbols denote the same or similar components. The following applies to the figures of the drawing: FIG. 1 shows a medical system according to the invention next to a blood treatment device in a highly simplified representation; 2 shows the treatment system according to the invention in a first embodiment; Fig. 3 shows the possible establishment of a technical parameter value (here the ultrafiltration rate) using the present invention over time; 4 shows the dependency of the extracted ultrafiltration volume on the venous dilatation in one embodiment; and FIG. 5 shows the dependence of the duration of a treatment session on the venous dilatation in one embodiment. 1 shows a highly simplified representation of a medical system 1 according to the invention in a first embodiment next to a blood treatment device 100 which is optionally connected to an extracorporeal blood circuit 300. FIG. 1 thus shows a treatment system according to the invention of an exemplary embodiment. The extracorporeal blood circuit 300 has a first line 301, here in the form of an arterial line section. The first line 301 is fluidly connected to a blood treatment device, here for example a blood filter or dialyzer 303. The blood filter 303 has a dialysis fluid chamber 303a and a blood chamber 303b, which are separated from one another by a mostly semi-permeable membrane 303c. The extracorporeal blood circuit 300 also has at least one second line 305, here in the form of a venous line section. Both the first line 301 and the second line 305 can be used to connect them to the vascular system of the patient P (not shown). The first line 301 is optionally connected to a (first) hose clamp 302 for blocking or closing the line 301 . The second line 305 is optionally connected to a (second) hose clamp 306 for blocking or closing the line 305 . The blood treatment device 100 represented schematically and only by some of its devices in FIG. 1 has a blood pump 101 . The blood pump 101 pumps blood through portions of the extracorporeal blood circuit 300 and toward the blood filter or dialyzer 303 during treatment of the patient P (see FIG. 2), as indicated by the small arrowheads which generally indicate the direction of flow in each of the figures. Fresh dialysis fluid is pumped from a source 200 along the dialysis fluid supply line 104 into the dialysis fluid chamber 303a by means of a pump for dialysis fluid 121, which can be designed as a roller pump or as an otherwise occluding pump. The dialysis fluid leaves the dialysis fluid chamber 303a as dialysate, optionally enriched by filtrate, in the direction of an optional effluent bag 400 and is referred to herein as effluent. The source 200 can be a bag or a container, for example. The source 200 may also be a fluid line from which on-line and/or continuously generated or mixed liquid is provided, e.g. B. a hydraulic outlet or connection of the blood treatment device 100. A further source 201 with a substituate can optionally be provided. It may correspond to source 200 or be a source of its own. A controller or regulator 150, only implied, may be configured to regulate or control the treatment session. At the bottom right within the blood treatment device 100 in FIG. 1 it is indicated where the optional effluent bag 400 is connected to the blood treatment device 100 . In addition to the aforementioned blood pump 101 and the aforementioned pump 121 for dialysis fluid, the arrangement shown in FIG. 1 also has a number of further, each optional pumps, namely the pump 111 for substituate and the pump 131 for the effluent. The pump 131 can optionally also be used to build up a negative pressure in the sense of ultrafiltration. The pump 121 is provided to supply dialysis fluid from a source 200, for example a bag, and via an optionally present bag heater H2 with a heating bag to the blood filter 303 by means of the dialysis fluid supply line 104. The dialysis fluid supplied in this way exits the blood filter 303 again via a dialysate discharge line 102 (also: effluent feed line), supported by the optional pump 131 and can be discarded. An optional arterial sensor PS1 is provided upstream of the blood pump 101 . During treatment of patient P (not shown here), he measures the pressure in the arterial line. A further, optional pressure sensor PS2 is provided downstream of the blood pump 101, but upstream of the blood filter 303 and, if provided, upstream of an optional addition point 25 for heparin. It measures the pressure upstream of the blood filter 303 ("pre-hemofilter"). Yet another pressure sensor can be provided as PS4 downstream of the blood filter 303, but preferably upstream of the pump 131, in the dialysate outflow line 102 for measuring the filtrate pressure of the blood filter 303. Blood leaving the blood filter 303 flows through an optional venous blood chamber 29, which can have a ventilation device 31 and/or a further pressure sensor PS3. The control or regulating device 150 shown in FIG. 1 can be in wired or wireless signal communication with any of the components mentioned here—at least or in particular with the blood pump 101—for controlling or regulating the blood treatment device 100 . The optional pump 111 is provided to deliver substituate from the optional source 201, such as a bag, and to the second line 305 via an optional bag heater H1 with a heater bag. In some embodiments, a citrate solution is dispensed into the line 301 from an optionally provided source for citrate solution, here designed as a citrate bag 9, for example, optionally by means of a citrate pump 15. For example, 4% Na ₃ citrate is supplied from the source for citrate solution. An optional addition device, designed here as a calcium pump 12, is provided in order to deliver a calcium solution into the line 305 from an optional source for calcium solution, designed as a calcium bag 13 in FIG. 1 by way of example. For example, a CaCl ₂ solution is supplied from the calcium solution source. This can have a calcium concentration of 91 mmol/l, 100 mmol/l or another suitable calcium concentration. A medical system 1 according to the invention with a computing device 5 is shown on the right next to the blood treatment device 100 in FIG. 1 . The computing device 5 includes an input interface 51 for manually entering or automatically reading in results which were determined using a diagnostic device 700 (also: examination device) for carrying out a retinal vessel analysis of a patient P (see FIG. 2). Medical system 1 includes an output interface 53 for outputting at least one technical parameter value for blood treatment device 100 for treating patient P (not shown in Fig. 1) or at least one target treatment parameter value for treating patient P using blood treatment device 100. The computing device 5 is programmed, based on the results entered or read in via the input interface 51, to determine the target treatment parameter value or its level or the technical parameter value or its level, or the respective proposed or recommended change compared to a previous setting on the blood treatment device 100 or compared to a specification for the Determine control or regulation of the blood treatment device 100 for the treatment of the patient P. The change z. B. a change compared to a value previously used for treatment, an entry in the patient file or in the patient history, etc. be or include. Furthermore, the computing device 5 is programmed to output the determined technical parameter value and/or the determined target treatment parameter value, or their respective change for the operation of the blood treatment device 100, by means of an output interface 53. Such output can e.g. B. to a display device 500 done. This can be configured or programmed to display the results from the examination using the diagnostic device 700, the determined parameter values and/or the determined target treatment parameter values or their respective changes. The display device 500 can optionally be a printer. A memory device for storing or maintaining results of the examination by means of the diagnostic device, or storing such results, is provided according to the invention in some embodiments. Alternatively or additionally, the invention includes at least one device that enables data (in particular results of the examination using the diagnostic device, parameter values and/or target treatment parameter values) to be stored, kept available and/or displayed over time (ie as patient history). The present invention also encompasses the storage, provision and/or presentation of data, for example as mentioned herein, relating to patient collectives. Blood treatment device 100 and medical system 1 together represent an embodiment of a treatment system according to the invention. B. mobile phone or tablet, spatially separated from the blood treatment device 100 may be provided. In certain embodiments, the medical system 1 and the blood treatment device 100 are separate from one another. The term “separate from each other” can be used here, e.g. B. include a spatial, physical separation and / or a separation such that there is no signal communication between the blood treatment device 100 and the medical system 1. Alternatively or additionally, this can be understood to mean that one component (e.g. the medical system 1) is not part of the other component (e.g. the blood treatment device 100). In the embodiment shown in FIG. 1 , the output interface 53 of the medical system 1 has an interface with the control or regulation device 150 of the blood treatment device 100 or is in signal communication with it and/or physically connected to it or is part of it. In the latter cases, however, the devices connected in this way are no longer a treatment system according to the invention, but a blood treatment device 100 according to the invention have a data memory or are in signal connection with it. The user can call up a program running on the server via a website, for example, in order to run or initiate some steps of the method according to the invention. The medical system 1 can thus include a server. It can include user interfaces and/or user terminals such as computers, mobile phones or tablets that are set up to communicate with the server. It is also covered by the present invention that the medical system 1, in contrast to what is shown here, is identical to the control or regulation device 150 or is covered by it. Fig. 2 shows the treatment system according to the invention in a first embodiment with a medical system 1 according to the invention in cooperation with a blood treatment device 100 or its control or regulation device 150, including the treating doctor or medical staff D and a patient P. The diagnostic device 700, For example, the Retinal Vessel Analyzer from Imedos, which can operate as a standalone device and is already available on the market, is set up as a standalone device, for example on a dialysis station. The patients can be examined on it or with it, preferably non-invasively. An average examination only takes a few minutes. This can take place in different cycles and does not have to take place before each treatment. An examination at intervals of 2 to 4 weeks seems appropriate. Thus, in the example in Fig. 2, diagnostic device 700 determines the values of the ratio of the maximum venous dilatation to the base diameter of the vessel in percent (also: vMax) and the values of the ratio of the maximum arterial dilatation to the base diameter of the vessel in percent aMax (in Fig. 2 not shown) and transmits them, for example by means of a suitable network protocol, to the server, which preferably stores the treatment and patient data. The course of the values of aMax and vMax can also be saved over several examinations or treatment sessions. If the respective patient P is registered at a blood treatment device 100, then this sends in some Embodiments send a request to the server and receives the treatment data of the relevant patient P as a response. Preferably, the measured values for aMax and vMax can be displayed in a suitable view on a display device 500, which can be part of the blood treatment device 100. As a result of the measured values, the proposed technical parameter values, target treatment parameter values or further treatment modifications can be displayed and suggested to the attending physician. After the doctor or other qualified medical personnel have checked and confirmed the proposed determined parameter values or target treatment parameter values, these values can be taken over by the blood treatment device 100, in particular by means of the control or regulating device 150 of the blood treatment device 100, for the upcoming (or ongoing) treatment of the patient P and the blood treatment device 100, in particular its pumps 101, 111, 121, are controlled or regulated individually adapted to the patient P on the basis of the determined parameter values or target treatment parameter values. Fig. 3 shows the specification of the ultrafiltration rate, referred to in Fig. 3 as UF (in [ml/h]), over the period of time t ₁ , t ₂ , t ₃ (in [sec]) as an example - here over the Time changing – technical parameter value. The values of vMax and aMax as results of the retinal vessel analysis can be classified or subdivided in many ways, and different values for the technical parameters relevant to the treatment of the patient P can be assigned to them according to their class or characteristic or be assigned target treatment parameter values, such assignment being e.g. B. can be stored in data storage. A possible subdivision can be as follows, e.g. B. be done in tertiles: and or These numbers are purely exemplary and should not be understood as limiting. These values can serve as defaults, other values and other subdivisions are also contemplated. Depending on vMax, parameter values or target treatment parameter values or changes thereto are suggested. In the present example, if vMax is below the upper tertile, high volume HDF treatment is activated. This is understood here as a contribution to cardioprotective dialysis. Furthermore, in this example, the course of the UF rate is changed over time depending on the results of the retinal vessel analysis. The waveforms shown in Figure 3 are exemplary. One application to another Curve shapes are possible, equation (1) should apply for extracting the desired ultrafiltration volume U _g .

If vMax is within the upper tertile, e.g. For example, if a constant UF rate is applied, see the top curve in Fig. 3.

The ultrafiltration volume U _g to be withdrawn is specified, for example, by the attending physician or results from the measurement using a body composition monitor (BCM), if available, etc.

For U _a we get

(2)

The following applies:

(3)

If vMax is in the middle tertile, the UF rate results here as a function u ₂ (t,vMax), see the middle curve u ₂ (t,vMax) in FIG. Rate of the top representation in Fig. 3 (there: 1000 ml/h) withdraws more volume per time (now: around 1200 ml/h), but the UF rate curve should flatten out again quickly. As a result, the same ultrafiltration volume is initially withdrawn faster than in the top illustration, but later more slowly than there. For example:

(4)

where:

Ug, the total volume of ultrafiltration withdrawn over the duration of the treatment session

U _a the constant UF rate in the standard case (without modification based on the results of the retinal vessel analysis)

U ₀ the standard UF rate at the start of treatment U _0m (vMax) determined by the results of the retinal

Vascular analysis modified UF rate at baseline

U _max the maximum allowable UF rate

U ₁ vMax) the UF rate at the end of the treatment (modified by the result of the retinal vascular analysis) k a factor affecting the curvature of the function t _w the inflection point at which the change in direction of the curvature takes place t ₀ the time of the start of the Treatment session (at t=0) t ₁ the time at which the treatment session ends t ₂ (vMax) the time at which the treatment session ends, modified based on the results of the retinal vasculature analysis

If vMax is in the lower tertile, the middle curve u ₂ (t, vMax ^' ) in FIG. 3 can be changed to u ₃ (t, vMax), for example. To do this, in addition to the modifications of u ₂ (t,vMax) lengthens the duration of the treatment session (dialysis time), as shown by the bottom curve u ₃ (t,vMax) in FIG. FIG. 3 thus shows different UF rates over time, as well as the modification of the treatment duration, which for u ₃ in FIG. 3 was increased from 4 hours (4 h) to 4 hours and 33 minutes (4.55 h) as an example.

All parameters can be changed if required, e.g. B. by the doctor treating you.

Fig. 4 shows an exemplary procedure for proposing a change AU [in %] from an existing default setting U ₀ as a specification for the technical parameter value of the UF rate as a function of the venous, maximum dilatation vMax [in %].

The parameter U ₀ , which is understood here as the standard value or default setting for the UF rate, is influenced or changed by the results from the retinal vessel analysis plotted along the x-axis, for example as follows:

Based on the measured value of vMax, U ₀ , a constant start value or standard value of 1000 ml/h, for example, is B. maximum 50% of U ₀ increased.

This is done, for example, by interpolation using a straight line, as shown in FIG.

U _0m (vMax)= U _{0 *} (1+ ΔU(vMax)) (5) This course of the curve and the values used are purely exemplary and should not be understood as limiting. Any modifications are possible. It should preferably apply:

ΔU (vMax)≥ 0 and U _0m (vMax)≤ U _max

In order to keep the extracted UF volume unchanged, U ₁ (vMax ^' ) can be calculated as follows by substituting (3), (4) and (5) in

(1) and resolved by U ₁ (vMax) can be calculated:

5 shows the dependence of the change At (in [sec]) in the duration of the treatment session (as an example of a target treatment parameter) on the maximum venous dilation vMax (in [%]).

If vMax is in the lower tertile, the middle curve u ₂ (t,vMax) of FIG. 3 can be changed to u ₃ (t,vMax) as an example, as explained above. For this purpose, in addition to the modifications of u ₂ (t,vMax), the duration of the treatment session (dialysis time) is lengthened (see also the bottom curve u ₃ (t,vMax) in FIG. 3). With an unfavorable calcium/phosphate balance, calcification leads to increased stenosis in the vascular system. The excess phosphate can be better broken down as a result of a longer dialysis time, which can represent an advantage in the treatment of some patients who can be identified according to the invention. For this purpose, as with u ₂ (t, _vMax ), see above or the middle curve in FIG Start of treatment session or dialysis determined.

Further, a modified end time or duration of the treatment session or dialysis time is used as a change At to modify the preset t ₁ for the duration as

Example of target treatment parameter calculated. This is done, for example, by interpolation using a straight line, as shown in FIG. t ₂ (vMax)=t ₁ +Δt(vMax) (7) This course of the curve and the values used are purely exemplary and should not be understood as limiting. Any modifications are possible.

The following should apply: Δt(vMax)≥ 0

There are hardly any restrictions on extending the dialysis time. The longer dialysis lasts, the gentler it is for the patient. A reduction in blood flow appears appropriate here, which leads to a further change in a specification of a technical

parameter value (here the preset blood pump rate). In practice, however, the duration of dialysis may also be limited by economic and patient-related factors. So that the total volume of ultrafiltration withdrawn remains unchanged, U ₁ (vMax) can be calculated by inserting (3), (4) and (5) into (1) and solving for U ₁ (vMax):

Furthermore, if the dialysis machine has the option of sodium management, if vMax is below the upper tertile, sodium management is activated with a 0 balance, which can correspond to a possible value of the sodium balance or the target sodium level as a possible target treatment parameter.

The attending physician can modify the target sodium level in each case in order to have a positive influence on the intravascular volume. With sodium O balance, the patient's sodium level is the same before and after treatment.

In addition, when vMax is below the upper tertile, for example, the use of the Body Composition Monitor (BCM for short, which can optionally also be part of the treatment system) is recommended. When the BCM option is switched on, the treatment system or treatment device can be switched on at regular time intervals, e.g. B. every 4 weeks, request a new measured value, provided such is not transmitted automatically, for example by SmartCard or the like, or was. In some embodiments of the present invention, the determined values of vMax and aMax can be displayed as a graphic. In this way, a long-term history can be presented to the attending physician. In the case of increasing vMax and aMax values, a cardioprotective dialysis treatment may be indicated. In some embodiments, some or all changes in the parameter values or target treatment parameter values are given as a suggestion to the treating personnel. In certain specific embodiments, these suggestions must be expressly accepted before the changes are activated, ie transmitted to the control or regulating device 150 of the blood treatment device 100 (see FIGS. 1 and 2). The disclosure of the figures and their explanation are only exemplary. In particular, the curves shown do not have to be more linear. The respective course of the curve, as well as the absolute values, could be determined differently or modified by the doctor treating you.

List of reference symbols 1 medical system 5 computing device 9 source for citrate solution, here for example as a citrate bag 12 calcium pump 13 source for calcium solution, calcium bag 15 citrate pump 25 addition point for heparin (optional) 29 venous blood chamber (optional) 31 ventilation device 51 input interface 53 output interface 100 blood treatment device 101 blood pump 102 Dialysate drain line, effluent inlet line 104 Dialysis liquid inlet line 111 Pump for substituate 121 Pump for dialysis liquid, dialysis liquid pump 131 Pump for dialysate or effluent in effluent inlet line; Pump for ultrafiltration, ultrafiltration pump 150 control or regulating device 200 source with dialysis fluid 201 source with substituate, optionally 300 extracorporeal blood circuit 301 first line (arterial line section) 302 (first) hose clamp 303 blood filter or dialyzer 303a dialysis fluid chamber 303b blood chamber 303c semi-permeable membrane 305 second line (venous line section) 306 (second) hose clamp 400 effluent bag 500 display device 700 diagnostic device D attending physician; medical staff H1 bag heater H2 bag heater P patient PS1 arterial sensor PS2 pressure sensor (optional, "pre-hemofilter") PS3 pressure sensor PS4 pressure sensor t ₁ , t ₂ , t ₃ duration [sec] Δt change in duration UF ultrafiltration rate [ml/h] ΔU Change in ultrafiltration rate aMax arterial dilation; Ratio of maximum arterial dilatation to the base diameter of the vessel in percent vMax venous dilatation; Ratio of the maximum venous dilatation to the base diameter of the vessel in percent

Claims

1. Medical system (1) for determining setting values of a blood treatment device (100), with - a computing device (5) with an input interface (51) for an input and/or for reading in each case by means of a diagnostic device (700) for carrying out a results obtained from retinal vascular analysis of a patient (P); - an output interface (53) for outputting at least one technical parameter value for treating the patient (P) and/or at least one target treatment parameter value for treating the patient (P) using the blood treatment device (100), and/or for outputting proposed changes existing presets or defaults for the technical parameter value and/or the target treatment parameter value; wherein the computing device (5) is programmed - based on the results entered or read in by means of the input interface (51), the target treatment parameter value or the technical parameter value, and/or their respective proposed or advised change compared to the default setting or the specification, for the determine control or regulation of the blood treatment device (100) for treating the patient; and - to output the determined technical parameter value and/or the determined target treatment parameter value, or their respective change, by means of the output interface (53). 2. Medical system (1) according to claim 1, wherein the results are the venous and/or the arterial dilatation (aMax, vMax), build on this or include this. 3. Medical system (1) according to claim 1 or 2, further comprising - a display device (500), configured or programmed to display the results and/or the determined technical parameter value and/or the determined target treatment parameter value, or their respective change. 4. Medical system (1) according to one of the preceding claims, wherein the output interface (53) is or comprises a visual or graphic interface for the user or is connected to a graphic display device. 5. Medical system (1) according to any one of the preceding claims, wherein the output interface (53) is an interface with a control or Control device (150) of a blood treatment device (100) is or comprises. 6. Medical system (1) according to one of the preceding claims, wherein the output interface (53) is an interface with a server, a network protocol and/or a data storage device, or comprises one in each case. 7. Medical system (1) according to one of the preceding claims, wherein the medical system (1) is or has a mobile device, hand-held device, mobile phone, smartphone, tablet, etc. and/or an application suitable for this purpose. 8. Medical system (1) according to one of the preceding claims, further comprising - a diagnostic device (700) for carrying out a retinal vessel analysis of a patient (P). 9. Medical system (1) according to one of the preceding claims, wherein the technical parameter values or target treatment parameter values determined by the computing device (5) include the ultrafiltration volume for the current or forthcoming treatment session, the duration of the treatment, the type of treatment, the sodium management and/or the liquid management or each relate to or include changes hereto. 10. Medical system (1) according to any one of the preceding claims, wherein the medical system (1) has a control or regulating device (150). Blood treatment apparatus (100) or a part thereof, comprises it or is in signal communication with it. 11. Medical system (1) according to claim 10, wherein the control or regulating device (150) is programmed, the blood treatment device (100) which is a conveying device for a liquid, in particular an ultrafiltration pump (131), a blood pump (101) and/or or to control or regulate a dialysis fluid pump (121) on the basis of the calculated or ascertained technical parameter value or target treatment parameter value. 12. Blood treatment device (100), configured as a dialysis device, having a medical system (1) according to one of the preceding claims, or connected thereto. 13. Blood treatment device (100) according to claim 12, designed as a hemodialysis device, hemofiltration device or hemodiafiltration device, in particular as a device for acute, chronic renal replacement therapy or for continuous renal replacement therapy (CRRT = continuous renal replacement therapy). 14. Treatment system comprising or consisting of - one or more blood treatment devices (100), respectively designed as a dialysis device, in particular according to one of claims 12 to 13; - A medical system (1) according to any one of claims 1 to 11; wherein at least one or more of the blood treatment devices (100) on the one hand and the medical system (1) on the other hand are separate from one another. 15. A method for preparing an upcoming treatment or treatment session of a patient (P), which is to be carried out using a blood treatment device (100), comprising the steps of: - providing a medical system (1) according to the invention, a blood treatment device (100) according to the invention, a Treatment system, or using such a medical system (1), blood treatment device (100) and/or treatment system already provided; - Entering at least one result detected by means of the diagnostic device (700) into the input interface (51) of the computing device (5); and - reading from the output interface (53) at least one technical parameter value and/or at least one Target treatment parameter value, or at least a change in at least one of these values, for a treatment of the patient (P) by means of the blood treatment device (100); and - entering the read technical parameter value and/or target treatment parameter value, or their respective change, as a setting value in an input interface of the blood treatment device (100). 16. Digital storage medium, in particular in the form of a floppy disk, CD or DVD, EPROM, FRAM or SSD, with electronically readable control signals, designed to interact with a programmable computer system in such a way that a conventional computing device becomes a computing device (5) of a medical system ( 1) is reprogrammed according to any one of claims 1 to 11. 17. Computer program product, as a signal wave or with a program code stored on a machine-readable carrier, in order to interact with a programmable computer system in such a way that a conventional computing device is reprogrammed into a computing device (5) of a medical system (1) according to one of claims 1 to 11 becomes. 18. Computer program with a program code to reprogram a conventional computing device to a computing device (5) of a medical system (1) according to any one of claims 1 to 11 when the computer program runs on a computer.