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WO2025021867A1 - Dispositif de traitement médical, système et procédé de préparation et de suivi du traitement d'un patient - Google Patents

Dispositif de traitement médical, système et procédé de préparation et de suivi du traitement d'un patient Download PDF

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Publication number
WO2025021867A1
WO2025021867A1 PCT/EP2024/071013 EP2024071013W WO2025021867A1 WO 2025021867 A1 WO2025021867 A1 WO 2025021867A1 EP 2024071013 W EP2024071013 W EP 2024071013W WO 2025021867 A1 WO2025021867 A1 WO 2025021867A1
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WO
WIPO (PCT)
Prior art keywords
patient
unit
mobile unit
dialysis fluid
stationary
Prior art date
Application number
PCT/EP2024/071013
Other languages
German (de)
English (en)
Inventor
Stefan Perplies
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 WO2025021867A1 publication Critical patent/WO2025021867A1/fr

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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
    • A61M1/1654—Dialysates therefor
    • A61M1/1656—Apparatus for preparing dialysates
    • 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
    • A61M1/1613—Profiling or modelling of patient or predicted treatment evolution or outcome
    • 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
    • A61M1/28—Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
    • 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
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/63—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
    • 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
    • A61M1/1611—Weight of the patient
    • 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
    • A61M1/1654—Dialysates therefor
    • A61M1/1656—Apparatus for preparing dialysates
    • A61M1/166—Heating
    • 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
    • A61M1/1654—Dialysates therefor
    • A61M1/1656—Apparatus for preparing dialysates
    • A61M1/1672—Apparatus for preparing dialysates using membrane filters, e.g. for sterilising the dialysate
    • 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
    • A61M2205/3546—Range
    • A61M2205/3553—Range remote, e.g. between patient's home and doctor's office
    • 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
    • A61M2205/3546—Range
    • A61M2205/3561—Range local, e.g. within room or hospital
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A61M2205/52—General characteristics of the apparatus with microprocessors or computers with memories providing a history of measured variating parameters of apparatus or patient
    • 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
    • A61M2205/82—Internal energy supply devices
    • A61M2205/8206—Internal energy supply devices battery-operated
    • 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
    • A61M2205/82—Internal energy supply devices
    • A61M2205/8237—Charging means
    • 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
    • A61M2209/00—Ancillary equipment
    • A61M2209/08—Supports for equipment
    • 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
    • A61M2230/30—Blood pressure
    • 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
    • A61M2230/65—Impedance, e.g. conductivity, capacity

Definitions

  • Medical treatment device system and method for preparing and following up on a patient's treatment
  • the present invention relates to a medical treatment device, in particular according to claim 1, a system, in particular according to claim 13 and a method, in particular according to claim 15 or according to the respective preambles or generic terms of these claims.
  • Medical treatment devices such as those belonging to the present invention can in particular be blood treatment devices.
  • Blood treatment devices also include dialysis machines, which in turn can be subdivided at least into hemodialysis machines and machines for performing automated peritoneal dialysis.
  • Dialysis is a procedure for purifying the blood of patients with acute or chronic renal insufficiency.
  • procedures that require an extracorporeal blood circuit such as hemodialysis, hemofiltration or hemodiafiltration (hereinafter referred to as hemodialysis), and peritoneal dialysis, which does not require an extracorporeal blood circuit.
  • the blood is passed in an extracorporeal circuit through the blood chamber of a blood filter or dialyzer, which is separated from a dialysis fluid chamber by a semipermeable membrane.
  • a blood filter or dialyzer which is separated from a dialysis fluid chamber by a semipermeable membrane.
  • ultrafiltrate is removed from the patient's blood by applying a transmembrane pressure in the dialyzer, without dialysis fluid being passed on the side of the dialyzer membrane opposite or facing away from the patient's blood.
  • a sterile and pyrogen-free substitute preferably in the form of a solution, can be added to the patient's blood. Depending on whether this substitute is added upstream or downstream of the dialyzer, it is referred to as pre- or post-dilution.
  • the exchange of substances in hemofiltration takes place convectively.
  • Hemodiafiltration combines the processes of hemodialysis and hemofiltration. There is both a diffusive exchange of substances between the patient's blood and the dialysis fluid via the semipermeable membrane of a dialyzer, and a filtration of plasma water by a pressure gradient on the membrane of the dialyzer.
  • peritoneal dialysis the abdominal cavity of a patient is filled with a dialysis fluid through a catheter that is passed through the abdominal wall.
  • the fluid has a concentration gradient compared to the body's own fluids.
  • the toxins present in the body pass into the abdominal cavity via the peritoneum, which acts as a membrane.
  • the now used dialysis fluid in the patient's abdominal cavity which is also referred to as dialysate, is exchanged.
  • Osmotic processes can also remove water from the patient's blood via the peritoneum into the dialysis fluid and thus dehydrate the patient.
  • the dialysis procedures are usually carried out with the aid of automatic dialysis machines, such as those sold by the applicant under the designation 5008 or, for peritoneal dialysis, sleep. safe or S ILENCIA.
  • An object of the present invention is to provide a further medical treatment device and a system.
  • a method is to be specified for preparing a medical treatment device for an upcoming treatment of a patient.
  • the object according to the invention can be achieved by a medical treatment device with the features of claim 1 and with a system with the features of claim 13. In addition, it can be achieved by a method with the features of claim 15.
  • a medical treatment device comprising or consisting of a stationary unit and a mobile unit that can be separated from the stationary unit.
  • the fixed unit is connectable or connected to a water source, for example by means of a water supply pipe.
  • the water source may be immobile or stationary, also referred to herein as "domestic". It may be part of the supply system of the place where the treatment of the patient is to be carried out, for example the patient's home or a clinic. It can be a separate and/or external water container.
  • the connection can be made via a connection for a tap or in another way.
  • the stationary unit for disposal of dialysate i.e. used dialysis fluid
  • a water drain e.g. a stationary or domestic one, for example by means of a drain line.
  • Water supply line and/or drain line can be included in the fixed unit, connected to it, etc.
  • the stationary unit further comprises a mixing device which is configured or provided for producing dialysis fluid for treating the patient.
  • the production of the dialysis fluid can comprise heating it, for example to the patient's body temperature, to a predetermined operating temperature, to a temperature above the aforementioned temperatures, etc.
  • the mobile unit is designed to provide the patient with treatment, particularly renal replacement therapy. It can be used separately from the stationary unit for this purpose.
  • the mobile unit has at least one of the lines from the group consisting of dialysis fluid supply line to the patient, dialysate drain line from the patient and patient connection line for connection to the patient, and/or the connector(s) necessary to connect this line to the mobile unit, or is connected thereto.
  • the stationary unit and the mobile unit each have devices such as connections, lines and/or the like in order to be fluidically connected to one another, thus in order to be able to exchange fluids, in particular liquids such as dialysis fluid, dialysate and/or the like, between them.
  • devices such as connections, lines and/or the like in order to be fluidically connected to one another, thus in order to be able to exchange fluids, in particular liquids such as dialysis fluid, dialysate and/or the like, between them.
  • the system according to the invention comprises a medical treatment device according to the invention, a water source, e.g. a water tap, a water drain, e.g. a wash basin, and/or, e.g., a power connection or a voltage source for supplying the medical treatment device with electrical voltage.
  • a water source e.g. a water tap
  • a water drain e.g. a wash basin
  • a power connection or a voltage source for supplying the medical treatment device with electrical voltage.
  • the water source, water drain and/or power connection/voltage source can be, e.g., stationary and/or "domestic" structures.
  • the method according to the invention for preparing the medical treatment device for an upcoming treatment, in particular blood treatment or peritoneal dialysis, of the patient comprises the following steps:
  • a water drain e.g. a stationary or domestic one
  • a drain line can be used, for example, if one is provided.
  • connection steps may be omitted if such a connection already exists.
  • system according to the invention further comprises one or more of the following steps:
  • Moving e.g. pulling, pushing, rolling, etc., the mobile unit to the location where the patient is to be treated.
  • the place of the upcoming treatment can be a place specified by the patient in the house, apartment or home (in short: place of residence of the patient to be treated where he or she wishes to undergo the treatment.
  • Embodiments of the invention may have some, some or all of the following features in any combination, unless this is recognizably technically impossible for a person skilled in the art.
  • top is closer to the center of the earth or the lower edge of the figure than “top”.
  • patient we mean a person who requires treatment. This spelling does not provide any information about the gender or other characteristics of this person.
  • a “domestic” or “inpatient” device When reference is made here to a “domestic” or “inpatient” device, this means that this device is provided where the patient wishes to undergo treatment or where he wishes to have it carried out. This can be in the house, apartment or home of the patient to be treated, i.e. where the patient is at home, or in a clinic, a practice or another medical facility. In some embodiments, the domestic residence can be different from a clinic, a practice or other medical facility; in others, the terms "domestic” or “inpatient” also include such devices.
  • a fixed unit may also be or be referred to as a first unit herein.
  • the terms "fixed unit” and “first unit” are interchangeable herein in some embodiments.
  • a mobile unit When reference is made herein to a “mobile unit”, this means that the unit is typically moved, driven, shifted, moved or otherwise changed in position during or for the purpose of use, e.g. for the upcoming treatment of the patient. Changing the position can be facilitated by means of devices, for example by means of translation means such as rollers and/or handles.
  • a mobile unit can also be or be referred to as a second unit herein.
  • the terms “mobile unit” and “second unit” are interchangeable herein in some embodiments.
  • the medical treatment device is configured in some embodiments to carry out one, several or all of these method steps, in particular if these are automatically executable steps, in any combination or to control corresponding devices which are preferably based on the name of the respective method step (e.g. "determining” as a method step and “device for determining” for the device, etc.) and which can also be part of the device(s) according to the invention or can be connected to it in a signal connection.
  • method steps are mentioned herein, it is provided in some embodiments that these take place before or after a treatment of the patient, for example while the patient is not connected to the device, e.g. by means of a dialysis fluid inlet line, dialysate outlet line, patient connection line or the like, or when a treatment has not yet begun or has already ended.
  • the method steps described herein are carried out in the order stated herein, in an overlapping manner, or simultaneously.
  • the treatment of the patient can be finished or not yet started while, for example, the patient is not connected to the blood treatment device, e.g. because his body is not connected to the dialysis fluid inlet line, dialysate outlet line, or patient connection line, or while no fluid is being supplied to and/or removed from the patient.
  • the stationary unit and the mobile unit each have connections for electrically connecting them to one another.
  • the stationary unit of the medical treatment device according to the invention has a water purification device or is connected to such a device.
  • the fixed unit includes or is connected to a water supply line for connecting it to a stationary water source or water supply.
  • the stationary unit has a drain line for disposal of liquid, e.g. dialysate, via a water drain, e.g. a domestic one, or is connected to such a drain.
  • the stationary unit has at least one container for storing dialysis fluid concentrate or is connected to such a container.
  • the mobile unit has translation means and/or at least one handle.
  • Translation means can be, for example, two, three or more rollers or wheels which are provided on the mobile unit, e.g. pivotable and/or lockable. The mobile unit can rest on them.
  • the handle can be provided and designed for carrying or lifting the mobile unit, in some embodiments for pulling and/or pushing, in some embodiments for both.
  • the handle can be provided, for example, in a side or upper area on the mobile unit. Any number of handles as well as any suitable position of a handle are encompassed by the present invention.
  • the mobile unit has a reservoir or a main reservoir for receiving and temporarily storing the dialysis fluid mixed by the stationary unit, which can optionally be designed as a tank.
  • a reservoir or a main reservoir for receiving and temporarily storing the dialysis fluid mixed by the stationary unit, which can optionally be designed as a tank.
  • Such reservoirs are in particular not flexible foil bags, which are known for hanging or placing on peritoneal dialysis devices.
  • Such reservoirs are preferably in an interior, e.g. within a housing of the mobile unit. They can be hidden from the viewer's eye without opening or dismantling the mobile unit.
  • the reservoir or main reservoir and/or any other reservoir of the mobile unit can be insulated, for example similar to a thermos flask. This advantageously makes it possible to dispense with an additional heating device (with the associated higher power consumption, risk due to electrical voltage, risk of tripping over a power cable, with the advantage of being independent of the nearest power socket, etc.) in the mobile unit.
  • the mobile unit has a battery or other mobile power source, but does not have a power cable for connection to the power source of the room or is not or will not be connected to such a cable.
  • the fixed unit and/or the mobile unit comprise at least one sensor for determining at least one patient parameter (or current value thereof).
  • Determining or determining, in particular of data and/or values can be or include examining an existence or non-existence, capturing, recording, measuring, collecting, evaluating, processing, comparing, estimating, assessing or estimating, deducing, calculating, obtaining, achieving and/or recognizing.
  • a turbidimetric sensor can be provided in the drain line for disposing of liquid from the stationary unit, for example to measure turbidity of the dialysate and/or to determine its composition.
  • such a sensor is optionally a device for determining a patient's bioimpedance (BCM).
  • BCM bioimpedance
  • movable or fixed structures such as handles, with contacts, for example on the left and right of the housing of the stationary unit, can be provided, which enable a signal to be coupled into the patient, e.g. in order to determine the degree of overhydration that is to be treated.
  • such sensors can be incorporated into an optional weighing device, which additionally determines the patient's weight as a further patient parameter.
  • a weighing device without such sensors can also be included in the invention.
  • sensors are optionally provided to measure, for example, a patient's blood pressure, e.g. by means of a cuff, by means of radar or by means of an optical determination using pulse wave analysis.
  • the stationary unit and/or the mobile unit have at least one communication unit configured to exchange data with one or more units external to the medical treatment device, e.g. within a network, with external storage, with a cloud, etc., and/or to initiate the processing of data on the external unit.
  • One or more such external units are part of the system according to the invention in some embodiments.
  • Communication units are known to those skilled in the art. Communication units and the corresponding technology from the state of the art can be used here, e.g. peer-to-peer via Bluetooth, communication with a local network (LAN) or a wide-area network (WAN) or the like.
  • LAN local network
  • WAN wide-area network
  • a signal or communication connection between two components can be understood to mean a connection that is already in use. It can also be understood to mean that preparation for such a signal connection (wired, wireless or implemented in another way) exists, for example by coupling the two components, for example by means of pairing, etc.
  • Pairing is a process that takes place in the context of computer networks to establish an initial link between computer units for the purpose of communication.
  • the best known example of this is the establishment of a Bluetooth connection by means of which different devices (e.g. smartphone, headphones ) are connected to each other .
  • Pairing is sometimes also referred to as bonding .
  • the mixing device is configured to initiate the mixing of the dialysis fluid on the basis of the previously determined or recorded patient parameter(s).
  • the mixing device is configured to initiate mixing of the dialysis fluid based on data received from one or more of the external units.
  • This transmitted data can be stored raw data of the patient parameters and/or further processed data, for example resulting in a determined and/or optimized recipe (for the addition of various concentrates to high-purity water) for the dialysis fluid.
  • the stationary unit is configured to heat the dialysis fluid by means of a heating device, in particular to a predetermined temperature. It can have such a device.
  • the medical treatment device comprises or is connected to at least one conveying device.
  • the conveying device is configured in these embodiments to convey liquids between the stationary unit and the mobile unit, optionally in both directions.
  • the stationary unit and/or the mobile unit of the medical treatment device has at least one user interface which is configured to control or regulate the medical treatment device or at least one of its components.
  • this user interface can be implemented by means of a handheld communication device of the patient or another person, for example a doctor or other medical care personnel.
  • the user interface is configured to input and/or output additional patient parameters and/or to authenticate the patient or a user.
  • Programming required for this purpose e.g. in the form of a graphical user interface (GUI), and/or devices, e.g. a microphone, a loudspeaker, a camera or the like, can be provided and are encompassed by the present invention.
  • GUI graphical user interface
  • the water purification device consists of or has a reverse osmosis and/or a filter device.
  • the fixed unit does not have a unit or device for processing or recycling used dialysate into usable dialysis fluid and/or for supplying such processed dialysis fluid to the mobile unit, and/or it is not prepared, programmed or configured for this purpose.
  • the mobile unit has a mobile power supply, in particular a battery or a rechargeable battery.
  • the medical treatment device has a power connection or generally an electrical voltage supply, by means of which a mobile voltage supply of the mobile unit is charged, optionally via the stationary unit.
  • the medical treatment device is configured to adjust the formulation of dialysis fluid in the mobile unit based on patient parameters determined during treatment of the patient.
  • the patient parameters determined during the treatment of the patient can, in addition to vital parameters and/or the patient parameters already mentioned herein, alternatively or additionally include inputs from the patient or another person, for example text inputs, sound, image recordings and/or the like.
  • Devices required for this purpose keyboard, microphone, camera and/or the like
  • the system according to the invention comprises a dialysis fluid supply line and/or a dialysate drain line, which can have a common section - for example in the form of a patient connection line - and which are designed to be able to be connected to a body cavity or a vessel of the patient for the purpose of medical treatment.
  • this further comprises separating the fluid connection between the stationary unit and the mobile unit by means of the dialysis fluid line. This takes place before the mobile unit is brought to the location of the upcoming treatment of the patient.
  • the method comprises purifying water using the water purification device of the stationary unit before mixing the dialysis fluid. This can be done, for example, using a combination of filters and a reverse osmosis system, in particular to obtain pure or highly pure water.
  • the method includes merging the mobile unit with the stationary unit after completion of treatment of the patient.
  • the method further comprises establishing a renewed fluid connection between both units by means of the dialysis fluid line and/or by means of the dialysate line and exchanging dialysis fluid and/or dialysate between the mobile unit and the stationary unit using the renewed fluid connection.
  • the method comprises connecting the mobile unit to at least one of the lines from the group consisting of dialysis fluid supply line to the patient, dialysate drain line from the patient and Patient connection cable for connecting to the patient in preparation for the upcoming treatment of the patient.
  • the method includes connecting the power cable of the fixed unit to the power supply.
  • the method comprises determining or detecting at least one patient parameter by means of a sensor of the stationary unit, in particular before the start of the upcoming medical treatment and/or before mixing the dialysis fluid.
  • the method comprises further processing of the previously determined or recorded patient parameters, e.g. on a local and/or an external unit.
  • the method comprises determining a formulation for a dialysis fluid that is suitable for the patient to be treated or optimizing the same.
  • the method comprises mixing the dialysis fluid using the mixing device of the stationary unit on the basis of or taking into account the previously determined or recorded patient parameter(s). Mixing is carried out from (highly) pure water by adding one or more concentrates.
  • the method comprises
  • the method comprises heating the mixed dialysis fluid by means of a heating device, in particular to a predetermined temperature, for example the body temperature of the patient, preferably in the stationary unit, more preferably not in the mobile unit.
  • the method comprises pumping dialysate, i.e. used dialysis fluid, into the, e.g., domestic, water drain by means of the renewed fluid connection and through the drain line, optionally via the stationary unit.
  • dialysate i.e. used dialysis fluid
  • the method includes charging a mobile power supply of the mobile unit via a power connection of or to the stationary unit.
  • the method includes flushing the fixed unit and/or the mobile unit.
  • the method includes disinfecting the fixed unit and/or the mobile unit.
  • the method includes treating the patient using the mobile unit while this is fluidically and/or spatially separated from the stationary unit.
  • the method includes monitoring patient parameters using dedicated sensors on or in the mobile unit during treatment of the patient.
  • the method comprises adjusting the formulation of the dialysis fluid in the mobile unit and changing the dialysis fluid there, in particular based on the patient parameters determined during the treatment of the patient.
  • Pumps, actuators and/or valves of the stationary unit and/or the mobile unit of the system according to the invention are connected to a control device which may be comprised by the medical treatment device or may be connected to it in a signal connection, where necessary for control or regulation.
  • the control device can initiate the execution of all or substantially all of the method steps.
  • the method according to the invention can be carried out substantially or completely by the control device. It can be carried out partially by the control device, in particular those steps which do not require or involve human intervention and/or provision can be carried out by the control device.
  • the control device can serve as a pure control device or also as a regulating device.
  • the control device is present in or on the blood treatment device, for example together with other components or devices of the blood treatment device in a common housing of the blood treatment device.
  • control device is present either in the mobile unit or in the stationary unit. In other embodiments, one control device is present in the mobile unit and one in the stationary unit. In the latter
  • control devices may optionally be in contact with each other via a communication unit or signal connection.
  • this may include preparing the medical treatment device in advance, e.g. for treatment the next day.
  • this does not include connecting or preparing or holding bags with dialysis fluid, e.g. in the form of flexible or foil bags.
  • the blood treatment device is designed as a dialysis device, hemodialysis device, hemofiltration device or hemodiafiltration device, in particular as a device for the acute, the chronic
  • the mobile unit has a reservoir with or for dialysis fluid, which is not the main reservoir.
  • This reservoir can be used to hold dialysis fluid which is introduced into the peritoneum as part of a so-called final enema shortly before the end of the treatment session in order to be allowed to remain there.
  • This reservoir can be accessed via the same valve in use as the main reservoir, or via a different, second valve.
  • the mobile unit or its internal/external containers can be cleaned and disinfected or sterilized (for example by means of heat sterilization) after treatment and after reconnection to the stationary unit - and optionally after appropriate emptying.
  • the medical treatment device, the mobile unit and/or the stationary unit can be prepared to carry out such cleaning. In some embodiments, it can therefore be provided to be able to run a cleaning and/or emptying program for the aforementioned purpose.
  • it is provided to provide the user with a button, e.g. on a touchscreen, a hard key such as a switch, such as a rotary knob, a toggle switch or the like for its operation.
  • the cleaning and/or emptying program is started either immediately or with a time delay, e.g. at a time entered by the user or specified by default or after a time period entered by the user or specified by default has elapsed. It may be provided that before the start of the cleaning and/or emptying program.
  • the medical treatment device, the mobile unit and/or the fixed unit can be programmed to first check conditions such as whether the required connection condition exists between the mobile unit and the fixed unit, between one of the units and a cast, and the like. Warnings, notices, prompts with or without confirmation by the user can be displayed and/or to be confirmed with respect to these conditions, etc.
  • the medical treatment device, the mobile unit and/or the stationary unit or corresponding control devices thereof are programmed or are caused externally, e.g. via a network, the cloud, etc., to automatically start or initiate the cleaning and/or emptying program, in full or only selected steps thereof. This can be triggered by the reaching of predetermined times, the expiration of predetermined periods of time, the reaching of a predetermined number of treatment sessions carried out using the treatment device or similar.
  • the stationary unit after the mobile unit, which it initially filled with dialysis fluid, has been separated from it and is now reconnected to it, begins to clean the mobile unit, if necessary after waiting for any residual emptying that may still be necessary beforehand, for example of the main reservoir of the mobile unit.
  • the stationary unit can or must also be emptied and/or cleaned, the above statements regarding the mobile unit also apply to the stationary unit and vice versa.
  • Peritoneal dialysis per se can offer the advantage of eliminating frequent journeys between home and the treatment site.
  • the time saved and the lower effort compared to inpatient treatment of seriously ill patients can also have a positive effect on the patients' perceived mental stress, so that treatment goals are achieved more frequently and in a more sustainable manner.
  • the preparation, control and programming of the medical treatment device can advantageously be made more convenient and flexible.
  • a further advantage of the present invention can be that comprehensive information about the patient, including in his home environment, or about the treatment of the patient, can be obtained. This information can be evaluated and stored over time, for example, in order to make the treatment of the patient even more individual and thus safer and more tolerable.
  • the patient's feedback can be used, for example by means of a direct communication with a doctor or medical staff, contribute to patient safety.
  • the present invention may further have the advantage that no complex logistics network is required for the provision of the infusion bags containing the dialysis fluid or for their delivery to the individual patients.
  • a further advantage may be that the previously required storage effort for the infusion bags and/or solution bags at the patient's premises, which is particularly problematic in cramped living environments, is no longer necessary.
  • Another advantage is that patients, who are usually very seriously ill, no longer have to transport the heavy dialysate bags within their home environment (e.g. to the treatment site and after treatment to a drain).
  • the latter in particular represents both a physical and psychological relief for the patient.
  • a further advantage of the present invention can be that in the stationary unit the recipe of the dialysis fluid can be individually tailored to the patient to be treated, since on the one hand regular monitoring of the patient parameters, e.g. a precise measurement of overhydration using bioimpedance, and on the other hand individual mixing of the dialysis fluid, based on an appropriately designed algorithm, which can generate an individualized treatment for a patient based on the recorded patient parameters, is possible in the patient's home environment. This can be a great relief for the patient, but also for caring relatives, for example, if trips to a clinic and the time spent there are no longer necessary.
  • the provision of dialysis fluid suitable for the treatment can take place in advance, for example the day before. This can represent a further advantage.
  • the present invention can considerably simplify the workflow for medical personnel.
  • a further advantage of the present invention may be that the method according to the invention can be carried out largely automatically, i.e. without human intervention. This can help to save personnel costs, i.e. working time and costs.
  • the present invention advantageously offers a common machine platform for the clinical and private environment. This can help to increase time/cost efficiency and/or to use development, updates, etc. across multiple machine types universally and thus save resources. With regard to extended user guidance, additional data can be transferred from the external server to the control unit of the treatment device, which can represent a further advantage. In this way, user-friendliness and thus indirectly patient safety can be increased.
  • Fig. 1 shows a schematically highly simplified view of a system according to the invention in a first embodiment
  • Fig. 1a shows the mobile unit of the system of Fig. 1 during renal replacement treatment of a patient P;
  • Fig. 2 shows a schematically simplified view of a stationary unit of a system according to the invention in a further embodiment to illustrate its internal structure
  • Fig. 3 shows a simplified schematic view of a mobile unit of a system according to the invention in a further
  • Fig. 3a shows a simplified schematic view of the rear side of the mobile unit of Fig. 3; and Fig. 4 shows an example of a process sequence that can be carried out by means of the system according to the invention.
  • Fig. 1 shows a schematically highly simplified version of a system 100 according to the invention in a first embodiment.
  • the system 100 according to the invention comprises a medical treatment device 1 according to the invention, which in turn comprises a stationary unit 1a and a mobile unit 1b.
  • the stationary unit la is designed to be or be connected to a (domestic) water source 5 by means of a water supply line 7, in the present example of Fig. 1 a water tap.
  • a (domestic) water drain 13 by means of a drain line 11, in the example of Fig. 1 a washbasin.
  • corresponding line or water connections can be provided on the stationary unit la or on lines thereof and/or on the water source 5 or the water drain 13.
  • the stationary unit la is designed to be connected to a (domestic) voltage source 25, in the example of Fig. 1 a socket, by means of a power connection cable 25a.
  • the mobile unit 1b is designed such that it can be or is fluidly connected to the stationary unit 1a by means of one or more lines 27, 29 and/or corresponding connectors or connections.
  • corresponding connectors can be provided on the stationary unit la and/or on the mobile unit 1b or on lines therefrom.
  • the connection thus established should in particular serve to guide or pump liquid(s), for example dialysis liquid, from the stationary unit la to the mobile unit 1b, and vice versa, for example dialysate, from the mobile unit 1b to the stationary unit la.
  • an optional power connection 25c, 25d is also provided for electrically connecting the mobile unit 1b, here by way of example with the stationary unit 1a, in particular in order to charge an optional mobile power supply 25b (see Fig. 3a), e.g. a battery, of the mobile unit 1b.
  • an optional mobile power supply 25b e.g. a battery
  • the mobile unit 1b is further designed to subject a patient P to a treatment, in particular a renal replacement treatment, such as peritoneal dialysis (see the descriptions of the following figures) or to be used for this purpose.
  • a treatment in particular a renal replacement treatment, such as peritoneal dialysis (see the descriptions of the following figures) or to be used for this purpose.
  • the stationary unit la and/or mobile unit 1b can each have a communication unit 41, which is configured such that the units la, 1b can communicate with each other and/or with external units.
  • a communication unit 41 is arranged on the stationary unit la.
  • a communication unit can be arranged on another
  • Fig. 1a shows the mobile unit 1b of the system 1 of Fig. 1 during the treatment, here optionally a renal replacement treatment, of a patient P.
  • the mobile unit 1b as described herein, in the exemplary embodiment and use of Fig. 1a, is filled with dialysis fluid and fluidically separated from the stationary unit 1a and, in addition, optionally also electrically separated from the stationary unit 1a or the other voltage source for the mobile unit 1b and brought to the patient P, in particular moved.
  • translation means 50 in particular (pivotable and/or lockable) rollers, and/or at least one handle 61 can be provided.
  • the handle 61 can in some cases
  • the mobile unit may be provided for carrying or lifting, in others for pulling and/or pushing, and in still other embodiments for both.
  • a handle 61 is provided on the side of the mobile unit 1b, in other embodiments in an upper area. Both the number and the position of the handle 61 are purely exemplary and are not to be understood as limiting. Any number of handles 61 and any positions thereof on the mobile unit 1b are encompassed by the present invention.
  • the patient P can therefore sit down at a location that suits him and undergo renal replacement treatment there, provided that this location offers sufficient space for the mobile unit 1b of the system 100. He is not forced to undergo his treatment by means of the system 100 in the vicinity of the water tap 5 for the stationary unit 1a. Furthermore, the location at which the treatment is to be carried out can be spatially limited, since not the entire system 100 but only the mobile unit 1b has to fit there.
  • the patient P can connect or be connected to the mobile unit 1b for the purpose of his treatment - e.g. by means of a patient connection line 33, which in turn is connected to a dialysis fluid supply line 31 to the patient and a dialysate outlet line 32 from the patient or emerges therefrom.
  • Fig. 2 shows a schematically simplified view of the stationary unit la of the system 100 according to the invention in a further embodiment to illustrate its internal structure.
  • the stationary unit la preferably comprises a housing 3a, in or on which the components described below are provided.
  • the housing 3a in the example of Fig. 2 has the shape of a cylinder in cross section. This is purely exemplary and should not be understood as limiting. Any other shape, such as cuboid, is also encompassed by the present invention.
  • the stationary unit 1a optionally has a sensor 35 by means of which patient parameters can be determined or recorded.
  • a sensor 35 for example, the patient's glucose level or the like could be determined.
  • turbidimetric methods with corresponding sensors can be used.
  • the stationary unit la in the example of Fig. 2 optionally has a device for determining a patient's bioimpedance (BCM).
  • BCM patient's bioimpedance
  • handles 39 with contacts 39a are provided, for example on the left and right of the housing 3a, which enable a signal to be coupled into the patient P in order to determine the degree of his overhydration to be treated.
  • Such sensors can, for example, be embedded in an optional weighing device 37, which additionally determines the weight of the patient P as a further patient parameter.
  • Optional sensors are provided to measure, for example, a patient's blood pressure, e.g. by means of a cuff, by means of radar or by means of an optical determination using pulse wave analysis.
  • the data generated on the basis of the patient parameters recorded in this way can be further processed in or on an external unit 43 (shown as a cloud in Fig. 2), e.g. on a local and/or remote data processing unit.
  • the stationary unit 1a can, for example, have a communication unit 41 which is configured, programmed or prepared in order to Signal connection to the external unit 43, for example a network, an external, remote server or a cloud.
  • the signal connection can be intended/programmed/suitable for unidirectional or bidirectional transfer of data.
  • the communication unit 41 can use all means known in the prior art (e.g. Ethernet, Wi-Fi, Bluetooth, 5G, etc.).
  • the aggregated patient parameters, patient data or data can be used on a local or remote data processing unit to provide optimal treatment for the patient, in particular to determine an optimal formulation for the dialysis fluid.
  • further data e.g. treatment data
  • the formulation can be adjusted by mixing a more concentrated dialysis fluid and/or increasing the frequency or duration of treatment.
  • the stationary unit la optionally comprises a water purification device 9. Since the quality of the tap water supplied via the water supply line 7 is generally inadequate for the preparation of dialysis fluid, the tap water, or any other supplied fluid, can be purified of larger and smaller contaminants by means of the water purification device 9, for example by means of a combination of filters (e.g. activated carbon filters) and a reverse osmosis system (RO system), in order to finally obtain pure or highly pure water that can be used for the renal replacement treatment of the patient P.
  • filters e.g. activated carbon filters
  • RO system reverse osmosis system
  • At least one container for dialysis fluid concentrate (here also referred to as concentrate) and/or salts is also provided.
  • concentrate dialysis fluid concentrate
  • a first container 15 for example for concentrate there is a first container 15, for example for concentrate, and a second container 17, for example for salt.
  • the number and position of the containers 15, 17 is purely exemplary and should not be understood as limiting. Further optional containers, at any position in the system 100, for example in or on the housing 3a or outside thereof, are also encompassed by the present invention.
  • An optional mixing device 19 can be used to prepare the (highly) pure
  • This can then be conveyed to or into the mobile unit 1b via a connection 13, e.g. by means of corresponding lines provided for this purpose, as described herein.
  • a holder 45a is shown for a device on which a user interface 45 can be realized, for example a holder for a liquid crystal display (LCD), in particular that of a tablet, in particular a tablet of the patient or a user, or the like.
  • LCD liquid crystal display
  • the position of this holder 45a is purely exemplary and is not to be understood as limiting. Any other position on the housing 3a of the stationary unit 1a is also encompassed by the present invention.
  • a water tap 30 or another outlet can be provided on the fixed unit 1b, for example to supply bags, in particular for CAPD (continuous ambulatory peritoneal dialysis), or a
  • the secondary reservoir 53a of the mobile unit 1b (see Fig. 3a) is to be filled with pure, preferably highly pure, water.
  • a power connection 25c shown here as an example as a socket, can serve to electrically connect the mobile unit 1b to the stationary unit 1a, for example to charge its mobile power supply.
  • Fig. 2 also shows a drain line 11 which is intended to lead used dialysate from the mobile unit 1b via corresponding lines towards the water drain 13.
  • At least one pump, one line and/or valves can be provided on the side of the mobile unit 1b, by means of which used dialysate can be disposed of directly, i.e. without first having to be passed through the stationary unit 1a.
  • a control device, e.g. of the mobile unit 1b, can optionally be programmed accordingly in order to carry out or start such disposal on the user's instigation or automatically or semi-automatically.
  • the design of the stationary unit la has optional recesses 49 or rails in which translation means 50, for example rollers, of the mobile unit lb, e.g. as described herein, can be accommodated.
  • An optional heating device 70 can be provided at the location shown in Fig. 2 or at any other location of the fixed unit 1a.
  • Fig. 3 shows a simplified schematic view of the mobile unit 1b of the system 100 according to the invention in a further
  • a housing 3b of the mobile unit 1b which can contain the components described in more detail in the description of Fig. 3a.
  • a holder 45b for a device is shown, on which a user interface 45 can be realized, for example a holder for a liquid crystal display (LCD), in particular that of a tablet, in particular a tablet of the patient or a user, or the like.
  • LCD liquid crystal display
  • this holder 45b is purely exemplary and is not to be understood as limiting. Any other position on the housing 3b of the mobile unit 1b is also covered by the present invention.
  • Fig. 3 also has one, two or more optional loudspeakers 51 on the left side of the housing 3b, as seen from the viewer, which can, for example, issue instructions for operating the medical treatment device 1 according to the invention to the patient or the user.
  • two outflow or inflow valves 55 can be arranged, to which the dialysis fluid supply line 31 for conveying dialysis fluid from the mobile unit 1b to the patient P can be connected during the medical treatment of the patient P (see Fig. 1a).
  • the second of these two outflow or inflow valves 55 can be connected to a second reservoir, which is not the main reservoir 53, but e.g. with the secondary reservoir 53a or another reservoir.
  • This reservoir can be used to hold dialysis fluid, which is introduced into the peritoneum as part of a so-called final enema shortly before the end of the treatment session so that it is allowed to remain there.
  • This dialysis fluid can differ in terms of composition, osmolarity, etc. from that in the main reservoir 53.
  • this reservoir can be designed to be thermally insulating, etc.
  • both the main reservoir 53 and the second reservoir can, in some embodiments, be accessible via just one common valve.
  • a switching device for connecting one valve sometimes to the main reservoir 55 and sometimes to the second reservoir can be provided. It can therefore optionally be controllable by means of the control device.
  • a drain valve 57 is arranged here, to which the dialysate drain line 32 for conveying dialysate from the patient P to the mobile unit 1b can be connected during the medical treatment of the patient P (see Fig. 1a).
  • the mobile unit 1b preferably stands on translation means 50, e.g. pivotable (shown by means of a rotating double arrow) and/or lockable rollers, in order to be easily moved from its location at the stationary unit 1a to a location near the patient P or to where the renal replacement treatment is to take place.
  • translation means 50 e.g. pivotable (shown by means of a rotating double arrow) and/or lockable rollers, in order to be easily moved from its location at the stationary unit 1a to a location near the patient P or to where the renal replacement treatment is to take place.
  • This is also indicated in Fig. 3 by means of double arrows.
  • it can have at least one handle 61, the The number and position in Fig. 3 are also purely exemplary and are not to be understood as limiting.
  • the mobile unit 1a can in turn be additionally designed with a communication unit or be prepared for this. This is indicated by a WLAN icon. Everything stated here regarding communication units can also apply to the communication unit of the mobile unit 1b.
  • the block arrow labeled A points to the side facing the user in Fig. 3a, hereinafter also referred to as the back of the mobile unit 1b.
  • Fig. 3a shows a simplified schematic of the rear side of the mobile unit of Fig. 3, viewed from direction A (as described for Fig. 3). This side can be used for the fixed
  • the main reservoir 53 is fluidically connected to the inflow valve(s) 55. Content from the respective secondary reservoirs 53a can be added to this fluidic connection in order to adjust the concentration(s) of the dialysis fluid before it is delivered to the patient, if desired or necessary.
  • Fig. 3a The position of the translation means 50 in Fig. 3a, here the rollers, does not correspond to the position of the rollers in Fig. 3.
  • the rollers 50 are shown in the example of Fig. 3a with a view of their running surface, in a position in which they fit into the recesses 49 of the stationary unit la (see Fig. 2).
  • Fig. 4 shows an example of a sequence of a method according to the invention that can be carried out by means of the system 100 according to the invention.
  • a system 100 according to the invention is provided at the location (house, apartment, home, etc.) of a patient P.
  • the stationary unit la is connected by means of a water inlet line 7 to a (domestic) water source 5 for water supply, which provides, for example, tap water.
  • a drain line 11 of the stationary unit la is connected to a domestic water drain 13, for example a washbasin or the like, in each case permanently or temporarily, simultaneously or not.
  • the tap water can be cleaned or otherwise treated in process step M2, e.g. by means of a combination of filters (e.g. activated carbon filters) and a reverse osmosis system (RO system), in order to obtain pure or ultra-pure water.
  • filters e.g. activated carbon filters
  • RO system reverse osmosis system
  • patient parameters are determined or recorded by means of at least one sensor 35, 37, 39a on the stationary unit 1a of the system 100, for example as explained herein, in particular in the description of Fig. 2.
  • the data generated on the basis of the method step M3 can optionally be processed or further processed in method step M4, e.g. on an external unit 43, for example a local and/or remote data processing unit. Since a relatively large amount of computing power is generally required for statistical evaluations or for calculating large mathematical models, e.g. based on neural networks, the stationary unit 1a can, for example, have a communication unit 41, as described herein.
  • the dialysis fluid is fed into the mobile unit 1b, in particular a main reservoir 39 thereof, via at least one suitable line 27 or the connection 21.
  • conveying means such as pumps or the like can be provided on the part of the stationary unit 1a and/or on the part of the mobile unit 1b and are encompassed by the present invention.
  • the mobile unit 1b can then generally be transported without significant expenditure of force to the location in, for example, the patient's home where the treatment, in particular renal replacement treatment, is to take place.
  • translation means 50 for example, in particular pivoting, rollers, optionally with a braking device, and/or at least one handle 61, in particular as described herein, can be provided.
  • the renal replacement treatment of the patient which in certain embodiments does not form part of the present invention, is represented by method step M8.
  • the dialysis fluid is conveyed from the mobile unit 1b or its main reservoir 53 to the patient.
  • the conveying means or components required for this, such as pumps, valves, Line sections or the like can be provided by the mobile unit 1b and are encompassed by the present invention.
  • the mobile unit can additionally comprise sensors in order to determine and/or monitor patient parameters, for example the patient's blood pressure, before/during/after the treatment, for example as described above. If these patient parameters fall outside a predetermined range, the concentration of the dialysis fluid can be adjusted during the renal replacement treatment, for example as described herein, in particular with reference to Fig. 3a.
  • dialysate used dialysis fluid, also referred to herein as dialysate
  • the conveying means or components required for this can be provided by the mobile unit 1b and are covered by the present invention. This is represented by the method step M9.
  • process step MI O the mobile unit 1b is returned to the stationary unit 1a and reconnected there.
  • the dialysate is conveyed via the stationary unit la and the drain line 11, for example into the water drain 13, e.g. of the patient's home.
  • the conveying means or components required for this, such as pumps, valves, line sections or the like, can be provided by the stationary unit la and/or by the mobile unit 1b.
  • rinsing and/or disinfection of the stationary unit la and/or the mobile unit 1b can be provided.
  • Charging a voltage source of the mobile unit 1b by means of a power connection 25c, 25d to the stationary unit la can also be provided in this step.
  • first container e.g. for concentrate

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Abstract

La présente invention concerne un dispositif de traitement médical (1) comprenant une unité immobile (1a) et une unité mobile (1b) qui peut être séparée de l'unité immobile (1a). L'unité immobile (1a) peut être raccordée à une source d'eau (5), par exemple stationnaire ou domestique et/ou, au moyen d'une ligne de drainage (11), à un drain d'eau (13), par exemple stationnaire ou domestique, pour éliminer le dialysat, et comprend un moyen de mélange (19) qui est configuré pour préparer et/ou chauffer un fluide de dialyse pour traiter un patient (P). L'unité mobile (1b) est configurée pour permettre au patient (P) de subir un traitement, en particulier une thérapie de remplacement rénal, l'unité mobile (1b) comprenant au moins l'une des lignes du groupe consistant en une ligne d'alimentation en fluide de dialyse (31) vers le patient, une ligne de drainage de dialysat (32) provenant du patient, et une ligne de port de patient (33) pour un raccordement au patient, et/ou un raccord pour raccorder cette ligne à l'unité mobile (1b). L'unité immobile (1a) et l'unité mobile (1b) comprennent chacune des ports (27, 29) pour être mutuellement raccordés fluidiquement.
PCT/EP2024/071013 2023-07-24 2024-07-24 Dispositif de traitement médical, système et procédé de préparation et de suivi du traitement d'un patient WO2025021867A1 (fr)

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