EP4292096A1 - Système médical assisté par analyse vasculaire permettant de définir des valeurs de réglage d'un dispositif de traitement du sang - Google Patents

Système médical assisté par analyse vasculaire permettant de définir des valeurs de réglage d'un dispositif de traitement du sang

Info

Publication number
EP4292096A1
EP4292096A1 EP22706269.2A EP22706269A EP4292096A1 EP 4292096 A1 EP4292096 A1 EP 4292096A1 EP 22706269 A EP22706269 A EP 22706269A EP 4292096 A1 EP4292096 A1 EP 4292096A1
Authority
EP
European Patent Office
Prior art keywords
treatment
medical system
parameter value
blood treatment
blood
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP22706269.2A
Other languages
German (de)
English (en)
Inventor
Florian Hubert
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Fresenius Medical Care Deutschland GmbH
Original Assignee
Fresenius Medical Care Deutschland GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Fresenius Medical Care Deutschland GmbH filed Critical Fresenius Medical Care Deutschland GmbH
Publication of EP4292096A1 publication Critical patent/EP4292096A1/fr
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1601—Control or regulation
    • A61M1/1603—Regulation parameters
    • A61M1/1605—Physical characteristics of the dialysate fluid
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B3/00—Apparatus for testing the eyes; Instruments for examining the eyes
    • A61B3/10—Objective types, i.e. instruments for examining the eyes independent of the patients' perceptions or reactions
    • A61B3/12—Objective types, i.e. instruments for examining the eyes independent of the patients' perceptions or reactions for looking at the eye fundus, e.g. ophthalmoscopes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4836—Diagnosis combined with treatment in closed-loop systems or methods
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/40—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/0014—Special media to be introduced, removed or treated removed from the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/0042—Special media to be introduced, removed or treated filtrate, i.e. the fluid passing through the filter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/04—Liquids
    • A61M2202/0413—Blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/10—General characteristics of the apparatus with powered movement mechanisms
    • A61M2205/103—General characteristics of the apparatus with powered movement mechanisms rotating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/12—General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit
    • A61M2205/125—General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit with incorporated filters
    • A61M2205/126—General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit with incorporated filters with incorporated membrane filters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/12—General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit
    • A61M2205/127—General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit with provisions for heating or cooling
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3327—Measuring
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A61M2205/502—User interfaces, e.g. screens or keyboards
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/005—Parameter used as control input for the apparatus

Definitions

  • 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.
  • 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.
  • 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.
  • a medical 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.
  • 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.
  • 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 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.
  • 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.
  • machine-readable medium 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.
  • 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.
  • a computer program can be understood, for example, as a physical, marketable software product which has a program.
  • 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 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.
  • UF ultrafiltration
  • DVA dynamic retinal vascular analysis
  • a retinal camera also: fundus camera
  • the retinal vessel analyzer measures the diameter of arteries and veins the fundus.
  • DVA dynamic retinal vessel analysis
  • 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.
  • 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.
  • 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.
  • the system's computing device 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the output interface is or includes an interface with a server, a network protocol, and/or a data store.
  • 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.
  • 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.
  • 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.
  • 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.
  • the renal dose can be, for example, the target renal dose (TRD) or the effective renal dose (RRD).
  • TRD target renal dose
  • RRD effective renal dose
  • the renal target dose (TRD) can e.g. B. can be calculated using the following formula: Fresenius Medical Care 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 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the computing device connected to the output device and/or to the input interface, preferably in signal communication, or prepared for this.
  • the input interface may be or include a suitably configured touch screen, rotary switch, slider, keyboard, or the like.
  • provision can be made for results to be read in automatically at the input interface and for manual input to be permitted.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the diagnostic device is provided as a standalone device, e.g. B., provided on a dialysis station.
  • the diagnostic device is or is connected to a network (e.g.
  • the diagnostic device is attached to a blood treatment device, e.g. pivoted, e.g. B. by means of one or more ball joints.
  • 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.
  • the camera can be pivoted back to the back of the blood treatment device.
  • 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.
  • the results obtained in this way are transmitted to the medical system or the blood treatment device, by cable or wirelessly.
  • 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.
  • 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 .
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 .
  • 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.
  • 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 may be configured to regulate or control the treatment session. At the bottom right within the blood treatment device 100 in FIG.
  • the optional effluent bag 400 is connected to the blood treatment device 100 .
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • one component e.g. the medical system 1
  • the blood treatment device 100 e.g. the blood treatment device 100
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the proposed technical parameter values, target treatment parameter values or further treatment modifications can be displayed and suggested to the attending physician.
  • 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.
  • 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.
  • 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.
  • 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.
  • BCM body composition monitor
  • 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:
  • the middle curve u 2 (t, vMax ' ) in FIG. 3 can be changed to u 3 (t, vMax), for example.
  • 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. 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.
  • 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:
  • a constant start value or standard value of 1000 ml/h, for example, is B. maximum 50% of U 0 increased.
  • U 1 (vMax ' ) can be calculated as follows by substituting (3), (4) and (5) in
  • the middle curve u 2 (t,vMax) of FIG. 3 can be changed to u 3 (t,vMax) as an example, as explained above.
  • the duration of the treatment session (dialysis time) is lengthened (see also the bottom curve u 3 (t,vMax) in FIG. 3).
  • 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.
  • u 2 (t, vMax ) see above or the middle curve in FIG Start of treatment session or dialysis determined.
  • 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
  • t 2 (vMax) t 1 + ⁇ t(vMax) (7)
  • U 1 (vMax) can be calculated by inserting (3), (4) and (5) into (1) and solving for U 1 (vMax):
  • 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.
  • the patient's sodium level is the same before and after treatment.
  • vMax 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.
  • BCM Body Composition Monitor
  • 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.
  • 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.
  • some or all changes in the parameter values or target treatment parameter values are given as a suggestion to the treating personnel.
  • 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.

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Abstract

La présente invention concerne un système médical (1) permettant de définir des valeurs de réglage d'un dispositif de traitement du sang (100), lequel système comprend un dispositif de calcul (5) pourvu d'une interface d'entrée (51) pour une entrée et/ou pour la lecture respectivement de résultats déterminés au moyen d'un dispositif de diagnostic (700) pour l'exécution d'une analyse vasculaire rétinienne chez un patient (P) ; d'une interface de sortie (53) pour délivrer au moins une valeur de paramètre technique pour le traitement du patient (P) et/ou au moins une valeur de paramètre de traitement cible pour un traitement du patient (P) au moyen du dispositif de traitement du sang (100) et/ou pour délivrer des modifications proposées de spécifications ou préréglages existants pour la valeur de paramètre technique et/ou la valeur de paramètre de traitement cible.
EP22706269.2A 2021-02-11 2022-02-10 Système médical assisté par analyse vasculaire permettant de définir des valeurs de réglage d'un dispositif de traitement du sang Pending EP4292096A1 (fr)

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DE102021103209.1A DE102021103209A1 (de) 2021-02-11 2021-02-11 Gefäßanalysegestütztes medizinisches System zum Festlegen von Einstellwerten einer Blutbehandlungsvorrichtung
PCT/EP2022/053219 WO2022171728A1 (fr) 2021-02-11 2022-02-10 Système médical assisté par analyse vasculaire permettant de définir des valeurs de réglage d'un dispositif de traitement du sang

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