LU504789B1 - Medical treatment device, system and method for preparing and following up on a patient's treatment - Google Patents

Abstract

The present invention relates to a medical treatment device (1) comprising a stationary unit (1a) and a mobile unit (1b) which can be separated from the stationary unit (1a). The stationary unit (1a) can be connected to a water source (5), e.g. a stationary or domestic water source, and/or by means of a drain line (11) to a water drain (13), e.g. a stationary or domestic water source, for disposing of dialysate and comprises a mixing device (19) which in turn is configured to produce and/or heat dialysis fluid for treating a patient (P). The mobile unit (1b) is configured to subject the patient (P) to a treatment, in particular a renal replacement treatment, wherein the mobile unit (1b) has at least one of the lines from the group consisting of dialysis fluid supply line (31) to the patient, dialysate drain line (32) from the patient and patient connection line (33) for connection to the patient, and/or a connector for connecting this line to the mobile unit (1b). The stationary unit (1a) and the mobile unit (1b) each have connections (27, 29) in order to be fluidically connected to one another.

Description

230013 LU 1 21.07.2023

Fresenius Medical Care Deutschland GmbH

LU504789

Description

Medical treatment device, system and method for

preparation and follow-up of a patient's treatment

The present invention relates to a medical

Treatment device according to claim 1, a system according to

Claim 15 and a method according to claim 17 or according to

Each of the generic terms or generic terms of these

claims.

Medical treatment devices such as those belonging to the present invention can in particular

blood treatment devices.

Blood treatment devices also include dialysis machines, which in turn can be divided 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. Basically, a distinction is made between procedures with an extracorporeal

Blood circulation, such as hemodialysis, hemofiltration or hemodiafiltration (hereinafter referred to as

Hemodialysis) and peritoneal dialysis, which does not require extracorporeal blood circulation.

During hemodialysis, the blood is pumped into an extracorporeal

Circulation through the blood chamber of a blood filter or

dialyzer, which is separated from a dialysis fluid chamber by a semipermeable membrane.

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In hemofiltration, ultrafiltrate is removed from the patient's blood by applying a transmembrane pressure in the dialyzer, without dialysis fluid being deposited on the side of the membrane of the dialyzer opposite or facing away from the patient's blood.

In addition, the

A sterile and pyrogen-free substitute, preferably in the form of a solution, is 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

Postdilution. The exchange of substances takes place during

Convective hemofiltration.

Hemodiafiltration combines the procedures of

Hemodialysis and hemofiltration. There is a diffusive exchange of substances between the patient’s blood and

Dialysis fluid flows through the semipermeable membrane of a

dialyzer, as well as filtration of

Plasma water through a pressure gradient at the membrane of the

dialyzer.

In peritoneal dialysis, the abdominal cavity of a patient is filled with a dialysis fluid via a catheter passed through the abdominal wall, which

concentration gradient compared to the body's own

fluids. The membrane acts as a

The peritoneum is where the body’s

Toxic substances pass into the abdominal cavity. After a few hours, the 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

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Peritoneum into the dialysis fluid and the

Patients are thus dehydrated.

Dialysis procedures are usually carried out using automatic dialysis machines, such as those used by

Applicant under the designation 5008 or, for the

Peritoneal dialysis, sleep.safe or SILENCIA.

An object of the present invention is to provide a further medical treatment device and a system.

Furthermore, a method is to be specified for adapting a medical treatment device to an upcoming

to prepare for treatment of a patient.

The object of the invention is achieved by a medical

Treatment device with the features of claim 1 and with a system with the features of claim 15.

In addition, it is solved by a method having the features of claim 17.

According to the invention, a medical treatment device is proposed, comprising or consisting of a stationary

unit and a mobile unit that can be separated from the fixed unit.

The stationary unit is connectable or connected to a water source, for example by means of a

Water supply line. The water source can be immobile or stationary, also referred to herein as “domestic”. It can be part of the supply system of the place where the

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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.

Alternatively or in addition, the fixed unit is

Disposal of dialysate, i.e. used

Dialysis fluid, connectable or connected to a water drain, e.g. in a stationary or domestic environment, for example by means of a drain line.

Water supply line and/or drain line may be included in the fixed unit, connected to it, etc.

The stationary unit further comprises a mixing device which is configured or intended to produce dialysis fluid for the treatment of the patient. The

Preparing the dialysis fluid may include 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 set up to provide the patient with

treatment, in particular 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 cable for connection to the patient,

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LU504789 and/or the connector(s) required to connect this cable to the mobile unit, or is connected thereto.

The fixed unit and the mobile unit each have

Devices such as connections, lines and/or the like in order to be fluidically connected to each other, i.e.

Fluids, especially liquids such as dialysis fluid,

Dialysate and/or the like, between each other.

The system according to the invention comprises a medical treatment device according to the invention, a water source, e.g. a faucet, a water outlet, e.g. a wash basin, and/or a, e.g., power connection or a

Voltage source to supply the medical

Treatment device with electrical voltage.

Water source, water drain and/or

Power supply/voltage source can be, for example, stationary and/or “domestic” structures.

The method according to the invention for preparing the medical treatment device for an upcoming

Treatment, especially blood treatment or

Peritoneal dialysis, the patient includes the following

Steps: - Providing a medical device according to the invention

Treatment device; - connecting the fixed unit to a water source, e.g. stationary or domestic, which is done e.g. by means of a water supply pipe, thereby providing a

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Fluid connection between water source and stationary

Unit is effected or prepared, and/or - connecting the fixed unit to a, e.g. PB. stationary or domestic, water drain, whereby a

Fluid connection between water drain and stationary

Unity is brought about or prepared, for example, by a

drain line can be used if one is provided.

The above connection steps can be omitted if such a connection already exists.

Optionally, the system according to the invention further comprises one or more of the following steps: - Mixing dialysis fluid for use in

Treatment of the patient by means of the mixing device of the stationary unit and optionally heating it, for example to the patient's body temperature or another predetermined temperature; - Transfer of the mixed dialysis fluid from the stationary unit into a reservoir or main reservoir of the mobile unit by means of a

dialysis fluid line; and - moving, e.g. pulling, pushing, rolling, etc., the mobile unit to the location of the upcoming treatment of the

patients.

The place of the upcoming treatment can be a place specified by the patient in the house, apartment or home (in short:

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place of residence of the patient to be treated where he or she wishes to undergo the treatment.

Embodiments according to the invention may have some, some or all of the following features in any combination, unless this is recognizably technically impossible for the person skilled in the art.

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

Whenever numerical words are mentioned herein, the

Experts interpret this as an indication of a numerical lower limit.

If this does not lead to any noticeable

Therefore, if this leads to a contradiction, the person skilled in the art always reads "at least one" or "at least one" when stating "a" or "an". This understanding is also covered by the present invention, as is the interpretation that a numerical word such as "a" can alternatively be meant as "exactly one" wherever this is technically possible for the person skilled in the art. Both are covered by the present invention and apply to all numerical words used herein.

Whenever reference is made to spatial information, such as “above”, “below”, “left” or “right”, the

The expert hereby refers to the arrangement in the attached

Figures and/or in use. “Below” is the

closer to the center of the earth or the bottom edge of the figure than “top”.

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When we refer to a "patient" here, we mean a person who needs treatment. This spelling does not provide any information about the gender or other characteristics of this person.

When reference is made to a “user” here, this means the patient or a person who does not require treatment, for example medical

Staff, caring relatives or the like. From the

The spelling “user” does not provide any information about the gender or other characteristics of this person.

When referring to a “home” or “stationary”

When we talk about a device, we mean that this

The device is intended for the location where the patient wants to undergo treatment or where he wants to carry it out. This can be in the house, in the apartment or in the

Home of the patient to be treated, i.e. where the

Patient is at home, or in a clinic, a practice or other medical facility. The home

Residence may in some embodiments differ from a

clinic, practice or other medical facility, in others the terms “home” or “inpatient” also include such devices.

When reference is made to a ‘stationary unit’, this means that the unit is normally stationary during use, treatment or

The device must not be moved, driven, shifted, moved or altered in any way during the treatment session. This may be due, for example, to the fact that it is connected to stationary sources (water,

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power supply or the like). A stationary unit may also be or be referred to as a first unit herein. The

The terms “stationary unit” and “first unit” are used interchangeably herein in some embodiments.

When we refer to a “mobile unit” here, we mean that the unit is usually mobile during its

use or for their use, e.g. for the upcoming

Treatment of the patient, moved, driven, shifted, displaced or in any way altered in its position.

Changing the position can be facilitated by means of devices, for example

Translation means, such as rollers, and/or handles. A mobile unit can also be a second unit or be referred to as such. The terms “mobile

Unit” and “second unit” are used herein in some

Versions are interchangeable.

Advantageous further developments of the present invention are the subject of subclaims and

embodiments.

When an embodiment is mentioned herein, it represents an exemplary embodiment of the invention and is not to be understood as limiting.

If it is disclosed herein that the inventive

Object one or more characteristics in a particular

embodiment, it is also disclosed herein that the subject matter according to the invention has exactly this or these features in other, also inventive

Embodiments expressly does not have, e.g. in the sense

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LU504789 of a disclaimer. For each embodiment mentioned herein, it is therefore understood that the opposite embodiment, for example formulated as a negation, is also disclosed.

If method steps are mentioned herein, the medical treatment device according to the invention 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 corresponding devices, which preferably have a name based on the name of the respective process step (e.g. “determine” as

Process step and “device for determining” for the

Device, etc.) and which may also be part of the device(s) according to the invention or may be incorporated

signal connection can be controlled accordingly.

Whenever reference is made to programmed, set up or configured, these terms may in some cases

embodiments may be interchangeable.

If method steps are mentioned herein, it is intended in some embodiments that these take place before or after treatment of the patient, for example during

Patient is not connected to the device, e.g. via dialysis fluid supply line,

dialysate drain line, patient connection line or the like, or that treatment has not yet started or has already ended.

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Optionally, the method steps described herein are carried out in the order specified herein, in an overlapping manner, or simultaneously.

The treatment of the patient may at least be completed or not yet have started while, for example, the patient is not connected to the blood treatment device, e.g. because his body is not

Dialysis fluid supply line, dialysate drain line, or patient connection line, or while no fluid is being supplied to and/or removed from the patient.

In some embodiments of the medical treatment device according to the invention, the stationary

unit and the mobile unit each have connectors to be electrically connected to each other.

In some embodiments, the stationary unit of the medical treatment device according to the invention has a

water purification device or is connected to such a device.

In some embodiments, the stationary unit comprises a

Water supply line for its connection to a stationary

or is connected to a water source or water supply.

In some embodiments, the stationary unit comprises a

Drain line for disposal of liquid, e.g. dialysate, via a water drain, e.g. in the home, or is connected to such a drain.

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In some embodiments, the stationary unit comprises at least one container for storing

dialysis fluid concentrate or is connected to such.

In some embodiments of the inventive medical

The mobile unit has a treatment device

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 used in some embodiments for carrying or

Lifting of the mobile unit may be provided and designed accordingly, in some embodiments for pulling and/or pushing, in some embodiments for both.

The handle can, for example, be provided 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.

In some embodiments, the mobile unit comprises 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 used for

Attaching or placing on peritoneal dialysis machines are known. Such reservoirs are preferably in a

Inside, e.g. inside a housing of the mobile unit,

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LU504789. They can be hidden from the viewer's eye without opening or disassembling the mobile unit.

In certain embodiments, the reservoir or

Main reservoir and/or any other reservoir of the mobile

Unit can have insulation, for example similar to a thermos flask. This 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 which

Advantage of being independent of the nearest power socket, etc.) in the mobile unit can be dispensed with.

In some embodiments, the mobile unit comprises a

Battery or other mobile power source, but not a power cable to connect to the power source of the

Premises or is not or will not be connected with this.

In some embodiments, the stationary unit and/or the mobile unit comprise at least one sensor for

Determination of at least one patient parameter (or current value thereof).

An investigation or determination, in particular of data and/or

Values, an investigation of the existence or non-existence

Existence, a grasping, a recording, a measuring, a

Collecting, evaluating, processing, comparing,

Estimating, assessing or estimating, a deduction, a

Calculating, obtaining, achieving and/or recognizing may be or include.

Using such a sensor, in some

Embodiments of the patient's glucose levels or

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LU504789 or the like. For these or other measurements, turbidimetric methods for

be used.

In certain embodiments, a turbidimetric

Sensor may be provided in the drain line for disposal of liquid from the stationary unit, for example to measure turbidity of the dialysate and/or

to capture its composition.

In some embodiments, such a sensor is optionally a device for determining a bioimpedance of the

Patients (BCM). This can be mobile or fixed

Structures, such as handles, with contacts, for example on the left and right of the housing of the stationary

Unit, which allows coupling of a

signal in the patient, e.g. to determine the degree of overhydration that needs to be treated.

Such sensors may, in some embodiments, be embedded in an optional weighing device, which additionally measures the patient’s weight as a further

Patient parameters are determined. A weighing device without such sensors can also be included in the invention.

Optionally, in some embodiments, sensors are provided to detect, for example, the blood pressure of a patient, e.g. by means of a cuff, by means of radar or by means of an optical determination by means of

pulse wave analysis.

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In some embodiments of the medical treatment device according to the invention, the stationary

Unit and/or the mobile unit 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 inventive

system.

Communication units are known to the expert. Here, communication units and the corresponding

State-of-the-art technology can be used, e.g. peer-to-peer via Bluetooth, communication with a local area network (LAN) or a wide area network (WAN) or the like.

Whenever a signal or communication connection between two components is mentioned here, this can mean a

This can also be understood as the preparation for such a signal connection (wired, wireless or implemented in another way), for example by coupling both components, for example by means of pairing, etc.

Pairing is a process that occurs in the context of computer networks to establish an initial

Linking between computer units for the purpose of

Communication is established. The best known example of this is the establishment of a Bluetooth connection, by means of which various devices (e.g. smartphone,

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headphones) are connected to each other. Pairing is sometimes also referred to as bonding.

In some embodiments of the medical

Treatment device, the mixing device is configured to initiate the mixing of the dialysis fluid based on the previously determined or recorded patient parameter(s)

In some embodiments, the mixing device is configured to control the mixing of the dialysis fluid based on data received from one or more of the external

units. This transmitted data may contain stored raw data from the

Patient parameters and/or further processed data, for example resulting in a determined and/or optimized formulation (for the addition of various

concentrates to ultrapure water) for the

dialysis fluid.

In certain embodiments, the stationary unit is configured to supply the dialysis fluid by means of a

Heating device, in particular to a predetermined temperature. It can have such a.

In some embodiments, the medical

Treatment device has at least one conveyor device or is connected to such a device. The conveyor device is configured in these embodiments to

Liquids between the stationary unit and the mobile

To promote unity, optionally in both directions.

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In some embodiments, the stationary unit and/or the mobile unit of the medical

Treatment device has at least one user interface which is used to control or regulate the medical

Treatment device or at least one of its

Components are configured. In particular, this

User interface using a handheld

communication device of the patient or another

person, for example a doctor or other medical caregiver.

In some embodiments, the user interface is configured to input and/or output additional patient parameters and/or to authenticate the patient or a

User. The necessary programming, e.g. in the form of a Graphical User Interface (GUI), and/or

Devices such as a microphone, a loudspeaker, a camera or the like may be provided and are encompassed by the present invention.

In some embodiments, the

Water purification device consisting of a reverse osmosis and/or a filter device or has such.

In some embodiments, the mobile unit has a mobile power supply, in particular a battery or a rechargeable battery.

In some embodiments, the medical

Treatment device has a power connection or generally an electrical power supply by means of which a mobile power supply of the mobile

unit, optionally via the stationary unit.

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In some embodiments, the medical

Treatment device configured to prepare the

Dialysis fluid in the mobile unit based on data obtained during patient treatment

patient parameters.

The data obtained during the treatment of the patient

In addition to vital parameters and/or the patient parameters already mentioned herein, patient parameters can 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) can be provided and are covered by the present invention.

In some embodiments, the inventive

System a dialysis fluid supply line and/or a

Dialysate drain line, which may have a common section - for example in the form of a patient connection line - and which are designed to be connected to a

to be able to be connected to a patient's body cavity or vessel for the purpose of medical treatment.

In some embodiments of the method according to the invention, this further comprises separating the

Dialysis fluid line between the stationary unit and the mobile unit. This takes place before the mobile unit is brought to the location where the patient is to be treated.

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In some embodiments, 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, by means of a

Combination of filters and a reverse osmosis system, especially to obtain pure or ultra-pure water.

In some embodiments, the method comprises

Merging the mobile unit with the stationary unit after completion of the patient's treatment.

In some embodiments, the method further comprises

Reestablishing a fluid connection between both

Units by means of the dialysis fluid line and/or by means of the dialysate line and the exchange of

Dialysis fluid and/or dialysate between the mobile

unit and the stationary unit using the renewed

fluid connection.

In some embodiments, 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 patient's upcoming treatment.

In some embodiments, the method comprises

Connecting the power cable of the fixed unit to the power supply.

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In some embodiments, the method comprises

Determining or recording 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.

In some embodiments, the method comprises

Further processing of the previously determined or recorded

Patient parameters, e.g. on a local and/or external unit.

In some embodiments, the method comprises

Determining a suitable treatment for the patient to be treated

Recipe for a dialysis fluid or an optimization of the same.

In some embodiments, the method comprises

Mixing the dialysis fluid using the

Mixing device of the stationary unit based on or under

Taking into account the previously determined or recorded patient parameter(s). Mixing is done from (highly) pure water by adding one or more

concentrates.

In some embodiments, the method comprises

Mixing the dialysis fluid using the

Mixing device of the stationary unit based on the further processed patient parameters or on the basis of the previously determined and/or optimized recipe. The

Mixing is also done here from (highly) pure water by adding one or more concentrates.

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In certain embodiments, the method comprises a

Heating the mixed dialysis fluid using a

Heating device, in particular to a predetermined

Temperature, for example the body temperature of the

Patients, preferably in the fixed unit, more preferably not in the mobile unit.

In some embodiments, the method comprises

Pumping of 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.

In some embodiments, the method includes charging a mobile power supply of the mobile unit via a power connection of the stationary unit.

In some embodiments, the method includes flushing the stationary unit and/or the mobile unit.

In some embodiments, the method comprises

Disinfecting the fixed unit and/or the mobile

Unit.

In some embodiments, the method comprises

Treating the patient using the mobile unit while it is fluidically and/or spatially separated from the stationary unit.

In some embodiments, the method comprises

Monitoring patient parameters using sensors provided on or in the mobile unit during patient treatment.

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In some embodiments, the method comprises

Adjusting the recipe of the dialysis fluid in the mobile

Unit and changing the dialysis fluid there, especially based on the during the treatment of the

patient parameters determined by 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 is comprised by the medical treatment device or can be connected to it in signal connection, where

Control or regulation required.

The control device can control the execution of all or part of

Essentially all of the method steps can be carried out. The method according to the invention can be carried out essentially or completely by the control device. It can be carried out partially by the control device, in particular those steps can be carried out by the control device which require human intervention and/or

Provision does not require or concern. The

Control device can serve as a pure control device or also as a regulating device.

In some embodiments, 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.

In some embodiments, the control device is located either in the mobile unit or in the stationary

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Unit. In other embodiments, there is a

Control device in the mobile unit and one in the fixed unit. In the latter

Embodiments, these control devices can optionally be connected to each other via a communication unit or

signal connection are in contact with each other.

In some embodiments of the method, this may be a

Preparing the medical treatment device in advance, e.g. for treatment on the next

day, include.

In some embodiments of the method, this does not include connecting or preparing or holding bags with dialysis fluid, e.g. in the form of flexible or

foil bags.

In some embodiments, the

blood treatment device as a dialysis device,

Hemodialysis device, hemofiltration device or

Hemodiafiltration device, in particular as a

Device for acute, chronic

Renal replacement therapy or for continuous

Renal replacement therapy (CKRT = continuous kidney replacement therapy).

In some embodiments, the mobile unit comprises 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 remain there. This reservoir can be filled with the same

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Valve should be accessible in use like the main reservoir, or via another, second valve.

The mobile unit or its internal/external containers, such as the main reservoir or other reservoirs, can be removed after treatment and after reconnection to the stationary unit - and optionally after appropriate

Emptying - cleaned and disinfected or sterilized (for example by means of heat sterilization). 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 use a

In some embodiments, it is provided that the

Users click a button, e.g. on a

Touchscreen, a hard key like a switch, such as a

Rotary knob, a toggle switch or the like for its

operation. If the user presses this switch,

button or similar, the user starts the cleaning and/or emptying program, 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

One or more monitoring steps can be carried out during the emptying program. This allows the medical

Treatment device, the mobile unit and/or the fixed unit must be programmed to first check conditions such as whether the required connection state exists between the mobile unit and the fixed unit, between one of the units and a cast and the like. Warnings, notices, requests with or without

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Confirmation by the user can be made with reference to this

States must be displayed and/or confirmed, etc.

In certain embodiments, the medical

Treatment device, the mobile unit and/or the stationary unit or corresponding control devices thereof are programmed or are controlled externally, e.g. via a

Network, the cloud, etc., to start or initiate the cleaning and/or emptying program automatically, in whole or in part.

Triggers for this can be the achievement of predetermined

Points in time, the expiration of predetermined periods of time, the achievement of a predetermined number of

For example, it may be provided that the fixed unit, after the treatment sessions initially carried out with the treatment device,

The mobile unit filled with dialysis fluid has been separated from it and is now reconnected to it, and begins to clean it, if necessary after waiting for any residual emptying that may be required beforehand, for example of the main reservoir of the mobile unit.

Cleaning can be done by heating cleaning fluid,

This may include the introduction and discharge of cleaning fluid into the internal/external containers such as the main reservoir or other reservoirs of the mobile unit, etc.

Since the stationary unit can or must also be emptied and/or cleaned, the above applies to the mobile unit

The same applies to the stationary unit and vice versa.

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

Peritoneal dialysis can offer the advantage of eliminating frequent trips between home and treatment. The time saved and the reduced effort in

Comparison to inpatient treatment of severely ill patients

Patients can also positively influence the perceived mental

Influence the burden on patients, so that

Treatment goals are achieved more frequently and sustainably.

By means of the present invention, 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 his home environment, or about his treatment, can be obtained. This information can, for example, be evaluated and stored over time in order to

To make the treatment of the patient even more individual and therefore safer and more tolerable. In addition, the patient’s feedback, for example through 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 bag with the dialysis fluid or for its

delivery to individual patients is required.

230013 LU 27 21.07.2023

Fresenius Medical Care Deutschland GmbH

LU504789

A further advantage may be that the previously required storage effort for the infusion bags and/or

Solution bag in the patient, which is particularly important in confined

Living environment is a problem, is omitted.

In addition, the fact 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 to a drain after treatment) can be a further advantage.

The latter in particular represents both physical and psychological relief for the patient.

A further advantage of the present invention may be that in the stationary unit the recipe of the

Dialysis fluid tailored to the patient to be treated

Patients can be tailored to their needs, as regular monitoring of patient parameters, e.g. precise measurement of overhydration using bioimpedance, and individual mixing of the

Dialysis fluid, based on an appropriately designed algorithm, which is based on the recorded

Patient parameters can generate an individualized treatment for a patient, in the home environment of the

This can be a great relief for the patient, but also for nursing staff, for example.

Relatives, for example, if trips to a clinic and the stay there are no longer necessary.

By means of the present invention, the provision of dialysis fluid suitable for the treatment can be carried out in advance, for example the day before. This can represent a further advantage.

230013 LU 28 21.07.2023

Fresenius Medical Care Deutschland GmbH

LU504789

Advantageously, 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 expenses, i.e. working time and costs.

By using a dialysis fluid formulation that is individually optimized and/or perfectly tailored to the patient to be treated, patient tolerance of the treatment and the medical outcome can be indirectly improved.

The present invention advantageously provides a common machine platform for the clinical and private environment. This can help to reduce the time/

To increase cost efficiency and/or development,

Updates, etc. can be used universally across multiple machine types and thus save resources.

For enhanced user guidance, additional data can be transferred from the external server to the

control device of the treatment device, which can be a further advantage. In this

In this way, user-friendliness and thus indirectly patient safety can be increased.

All advantages achievable with the method according to the invention can be achieved in certain embodiments according to the invention

230013 LU 29 21.07.2023

Fresenius Medical Care Deutschland GmbH

LU504789 can also be achieved without any reduction using the devices according to the invention, and vice versa.

In the following, the present invention is described purely by way of example with reference to the accompanying figures. In them, identical reference numerals designate identical or similar

components. The following applies:

Fig. 1 shows a schematically highly simplified version of a system according to the invention in a first embodiment;

Fig.la shows the mobile unit of the system of Fig. 1 during renal replacement treatment of a patient P;

Fig. 2 shows a simplified schematic of a stationary

Unit of a system according to the invention in another

embodiment to clarify its internal structure;

Fig. 3 shows a simplified schematic view of a mobile unit of a system according to the invention in a further

Embodiment from the outside in perspective view;

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.

230013 LU 30 21.07.2023

Fresenius Medical Care Deutschland GmbH

LU504789

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 fixed unit la is designed to be able to

Water supply line 7 is designed to be connected to a (domestic) water source 5, in the present example of Fig. 1 a water tap. In addition, it is designed to be connected to a (domestic)

Water drain 13, in the example of Fig. 1 a washbasin, to be connected or to be connected. Appropriate pipe or water connections can be provided for this purpose on the fixed

Unit la or on lines thereof and/or on the

Water source 5 or water drain 13 must be provided.

Furthermore, the stationary unit la is designed to be connected to a (domestic) power supply by means of a power connection cable 25a.

Voltage source 25, in the example of Fig. 1 a socket.

The mobile unit 1b is designed in such a way that it can be connected to the stationary

Unit la can be or is connected in fluid communication.

Appropriate connectors can be attached to the fixed

Unit la and/or at the mobile unit 1b or at

Lines from this should be provided. The thus produced

The connection is intended in particular to transport liquid(s), for example dialysis fluid, 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.

230013 LU 31 21.07.2023

Fresenius Medical Care Deutschland GmbH

LU504789

In some embodiments, an optional

Power connection 25c, 25d for the electrical connection of the mobile unit 1b, here exemplarily with the stationary

Unit la, in particular, an optional, mobile power supply 25b (see Fig. 3a), e.g. a

battery of the mobile unit 1b.

The mobile unit 1b is further designed to have a

Patient P of treatment, especially

Renal replacement therapy, such as

to undergo peritoneal dialysis (see the descriptions of the following figures) or to be used for this purpose.

The fixed unit la and/or mobile unit 1b can

Each have a communication unit 41 which is configured such that the units 1a, 1b can communicate with each other and/or with external units. In the example of Fig. 1, a

Communication unit 41 is arranged on the stationary unit 1a. A communication unit can be arranged at another

Place, as shown in Fig. 1, or be integrated into the respective unit 1a, 1b.

Fig. la shows the mobile unit 1b of the system 1 of Fig. 1 during treatment, here optionally a

renal replacement therapy, of a patient P.

For this purpose, the mobile unit 1b, as described herein, in the exemplary embodiment and

Using Fig. la filled with dialysis fluid and fluidically separated from the stationary unit la and optionally also electrically from the stationary unit la or another voltage source for the mobile unit 1b

230013 LU 32 21.07.2023

Fresenius Medical Care Deutschland GmbH

LU504789 separated and transferred to patient P, in particular moved.

In order to enable a change of location of the mobile unit 1b as easily and smoothly as possible,

Translation means 50, in particular (pivotable and/or lockable) rollers, and/or at least one handle 61 may be provided. The handle 61 may in some

In some embodiments it can be intended for carrying or lifting the mobile unit, in others for pulling and/or pushing, in still other embodiments for both. In the example of the

Fig. 1, 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.

Patient P can therefore sit at a location convenient for him and undergo renal replacement therapy there, provided that this location has sufficient space for the mobile unit 1b of the

System 100 offers. He is not forced to carry out his treatment using the system 100 near, for example, the water tap 5 for the stationary unit 1a. Furthermore, the location at which the treatment is to be carried out can certainly be spatially limited, since not the entire system 100 but only the mobile unit 1b has to fit there.

Patient P can - 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

230013 LU 33 21.07.2023

Fresenius Medical Care Deutschland GmbH

LU504789 a dialysate drain line 32 is connected by the patient or emerges therefrom - connect or be connected to the mobile unit 1b for the purpose of his treatment.

For a more detailed description of the treatment, please refer to the description in Fig. 4 to avoid repetition.

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 clarify 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 a 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.

In the example of Fig. 2, the stationary unit la optionally has a sensor 35, by means of which

Patient parameters can be determined or recorded.

By means of such a sensor 35, for example, the

For these or other measurements, turbidimetric methods with appropriate sensors can be used to

be used.

For patient parameter recording, the stationary

Unit la in the example of Fig. 2 optionally comprises a device for determining a patient’s bioimpedance (BCM).

For this purpose, handles 39 with contacts 39a, for example

230013 LU 34 21.07.2023

Fresenius Medical Care Deutschland GmbH

LU504789 on the left and right of the housing 3a, which provides a

Enable a signal to be coupled into patient P in order to determine the degree of overhydration that requires treatment.

Such sensors can be embedded in an optional

Weighing device 37, which additionally measures the weight of the

Patient P as another patient parameter.

Optional sensors are provided, for example to

To record a patient’s blood pressure, e.g. using a

cuff, by radar or by optical

Determination by pulse wave analysis.

The data generated on the basis of the patient parameters recorded in this way

Data 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. Since a relatively large amount of data is usually required for statistical evaluations or for the calculation of large mathematical models, e.g. based on neural networks,

Computing power is required, the stationary unit la may, for example, have a communication unit 41 which is configured, programmed or prepared 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. For this purpose, the

Communication unit 41 can use all means known in the state of the art (e.g. Ethernet, Wi-Fi, Bluetooth, 5G, etc.).

230013 LU 35 21.07.2023

Fresenius Medical Care Deutschland GmbH

LU504789

The aggregated patient parameters, patient data or

Data, such as the patient’s level of overhydration, blood pressure and/or weight, can be used on a local or remote data processing unit to provide optimal treatment for the patient, in particular an optimal prescription for the

Dialysis fluid can also be used to determine the best dialysis fluid for the patient. Additional data, such as treatment data, can also be used to determine a suitable or optimized formulation for the

Dialysis fluid for the treatment of a patient P (in

Fig. 2 not shown) and for an upcoming

treatment or treatment session.

The following example is given: If, for example, it can be determined that over a period of several weeks both the patient’s weight and

Overhydration has increased, the recipe can be adjusted to include a more concentrated

dialysis fluid is mixed and/or the frequency or duration of treatment is increased.

Known algorithms or mathematical models from the state of the art (statistical evaluation or regression analysis of historical data and/or neural networks) can be used to calculate such optimized prescriptions. Such optimization and/or the provision of the data thus determined can form the basis for an (optimized)

formulation of a dialysis fluid, which can also be determined by or on the external unit 43.

The fixed unit la optionally includes a

Water purification device 9. Since the quality of the water supplied via the water supply line 7

230013 LU 36 21.07.2023

Fresenius Medical Care Deutschland GmbH

LU504789

If the amount of tap water is insufficient for the preparation of dialysis fluid, the tap water, or any other supplied fluid, can be

Water purification device 9, for example by a

Combination of filters (e.g. activated carbon filters) and a

Reverse osmosis system (RO system), from larger and smaller

impurities to obtain pure or ultrapure water, which is suitable for

renal replacement treatment of patient P.

In the system 100, here for example in or on the housing 3a of the stationary unit 1a, there is also at least one container for

Dialysis fluid concentrate (here also referred to as concentrate) and/or salts. In the example in Fig. 2, 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 not to 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

Water from the water purification device 9, the concentrate from the first container 15 and/or salt from the second

Container 17 Dialysis fluid for the treatment of

Patient P, for example his renal replacement treatment. 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.

230013 LU 37 21.07.2023

Fresenius Medical Care Deutschland GmbH

LU504789

On top of the housing 3a of the stationary unit 1a, or elsewhere, 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. The

Position of this holder 45a is purely exemplary and 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 stationary unit 1b, for example to supply bags, in particular for CAPD (continuous ambulatory peritoneal dialysis), or a

To fill the secondary reservoir 53a of the mobile unit 1b (see Fig. 3a) with pure, preferably highly pure, water.

A power connection 25c, shown here as an example as a socket, can be used 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 drain used dialysate from the mobile

Unit 1b via appropriate lines in the direction

water drain 13.

In any embodiment, at least

A pump, a line and/or valves are provided on the side of the mobile unit 1b, by means of which used dialysate can be directly, i.e. without first passing through the

230013 LU 38 21.07.2023

Fresenius Medical Care Deutschland GmbH

LU504789 fixed unit la can be disposed of. A control device, e.g. the mobile

Unit 1b may optionally be programmed to perform or start such disposal upon user request 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 1b, e.g. as described herein.

An optional heating device 70 can be provided at the location shown in Fig. 2 or at any other location of the stationary unit 1a.

Fig. 3 shows a schematically simplified view of the mobile unit 1b of the system 100 according to the invention in a further

Embodiment from the outside in perspective view.

It shows a housing 3b of the mobile unit 1b, which has the features described in more detail in the description of Fig. 3a.

may contain components.

In the perspective of Fig. 3, in the right side of the housing 3b, as seen by the viewer, 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 (Liquid Crystal

Display (LCD)), in particular that of a tablet, in particular a tablet of the patient or a user, or the like.

230013 LU 39 21.07.2023

Fresenius Medical Care Deutschland GmbH

LU504789

The position of this holder 45b is purely exemplary and not to be understood as limiting. Any other position on the

Housing 3b of the mobile unit 1b is also encompassed by the present invention.

Furthermore, the embodiment of Fig. 3 also has one, two or more optional loudspeakers 51 in the left side of the housing 3b, as seen from the viewer, which can, for example, output instructions for operating the medical treatment device 1 according to the invention to the patient or the user.

On the side of the housing 3b of the mobile unit 1b facing the viewer, two outflow or

Inflow valves 55 are arranged to which during the medical treatment of the patient P the

Dialysis fluid supply line 31 for the delivery of

Dialysis fluid from the mobile unit 1b to the

Patient P can be connected (see Fig. la).

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 for example to 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, in order to remain there.

Dialysis fluid can vary in composition,

Osmolarity etc. from that which is in the

Main reservoir 53 is present. Like the main reservoir 53, this reservoir can be designed to be thermally insulating, etc.

230013 LU 40 21.07.2023

Fresenius Medical Care Deutschland GmbH

LU504789. Instead of two outflow or inflow valves 55, both the main reservoir 53 and the second

Reservoir in some embodiments can be accessed via only one common valve. A switching device for connecting one valve with the

Main reservoir 55, times with the second reservoir, can be provided. It can, optionally, be provided by means of the

control device.

Furthermore, a drain valve 57 is arranged here, to which the

Dialysate drain line 32 for conveying dialysate from

Patient P can be connected to the mobile unit 1b (see Fig. la).

The mobile unit 1b is preferably placed on

Translation means 50, e.g. pivotable (shown by a rotating double arrow) and/or lockable

Rolls to easily move from their location at the fixed

Unit la can be moved 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. Alternatively or additionally, it can have at least one handle 61, the

The number and position in Fig. 3 are also purely exemplary and not to be understood as limiting.

The mobile unit la can in turn be supplemented with a

Communication unit can be designed or prepared for this purpose. 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.

230013 LU 41 21.07.2023

Fresenius Medical Care Deutschland GmbH

LU504789

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 view of the rear side of the mobile unit of Fig. 3, viewed from direction A (as

Fig. 3). This side can be assigned to the fixed

Unit 1a when the mobile unit 1b is fluidically and/or electrically connected to the stationary unit 1b.

Please refer to the descriptions of the preceding figures

reference is made.

In Fig. 3a, further components are indicated which

Each and independently from the housing 3b of the mobile

Unit 1b includes or can be arranged on it. These optional components will be discussed below.

The mobile unit 1b has a main reservoir 53 and at least one secondary reservoir 53a. The main reservoir 53 can be connected to the main reservoir 53 by means of the connection 21 shown in Fig. 2 via a

Dialysis fluid line 27 (indicated as a short line in Fig. 3a) can be filled with dialysis fluid 27, which has previously, preferably based on current

Patient parameters, in the stationary unit la was individually mixed for the patient to be treated. The secondary reservoir(s) 53a can be or are filled with, in particular, highly pure water, concentrate and/or salts.

230013 LU 42 21.07.2023

Fresenius Medical Care Deutschland GmbH

LU504789

The main reservoir 53 is fluidically connected to the

Inlet valves 55. In this fluidic

Compound content from the respective secondary reservoirs 53a can be added to adjust concentration(s) of

Dialysis fluid can be adjusted again before it is delivered to the patient if desired or necessary.

To avoid the need to adapt the recipe of the

To detect dialysis fluid, the mobile unit can include additional sensors to detect before/during/after

Treatment to determine and/or monitor patient parameters, such as the patient’s blood pressure, for example as set out herein. If these

Patient parameters from a predetermined range, the

Concentration of the dialysis fluid during

Renal replacement treatment (“on the £1y”), for example through

Adding water, concentrate or salts from one of the

secondary reservoir 53a.

As an electrical connection option for the mobile

Power supply 25b, for example a battery, of the mobile unit 1b is a power connection 25d in Fig. 3a, in the present example of Fig. 3a in the form of a plug, for

Connection to the power connection 25c of the fixed

Unit la (socket, see Fig. 2). Socket and plug are mentioned here purely as examples and are not to be understood as limiting. Other methods for charging a mobile power supply 25b, e.g. induction, replaceable batteries or the like, can also be provided and are covered by the present invention.

The mobile unit 1b further comprises a dialysate reservoir 63 which stores used dialysis fluid, also referred to herein as

230013 LU 43 21.07.2023

Fresenius Medical Care Deutschland GmbH

LU504789

Dialysate, which can be fluidically connected to the dialysate reservoir 63 with the

Dialysate drain line 32 (see Fig. la) via the

Drain valve 57 from the patient P to the mobile unit 1b. The conveying means required for this can be provided by the mobile unit 1b and are covered by the present invention.

If the mobile unit 1b has been returned to the stationary unit 1a and connected to it, the dialysate from the dialysate reservoir 63 of the mobile unit 1b can be discharged via the

Dialysate line 29 (indicated as a short line in Fig. 3a) into the stationary unit la and from there, for example, into the

Water drain 13 (see Fig. 1) and disposed of there.

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 in Fig. 3a with regard to their

Tread shown in a position in which it is in 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.

Reference is made to the description and reference numerals of the preceding figures.

In method step M1, a system 100 according to the invention is installed at the location (house, apartment, home, etc.) of a

Patient P is provided. The stationary unit la is

230013 LU 44 21.07.2023

Fresenius Medical Care Deutschland GmbH

LU504789 by means of a water supply line 7 to a (domestic)

Water source 5 is connected to the water supply, which provides, for example, tap water. Furthermore, a

Drain line 11 of the fixed 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.

Since the quality of tap water is usually

If the preparation of dialysis fluid is insufficient, 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) to produce pure or ultra-pure

to obtain water.

In the optional method step M3, at least one sensor 35, 37, 39a on the stationary unit la of the

System 100 determines or records patient parameters, for example as set out 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 statistical

evaluations or for the calculation of large mathematical

Models, e.g. based on neural networks, require a relatively large amount of computing power, the stationary unit la can, for example, be controlled via a

communication unit 41 as described herein.

230013 LU 45 21.07.2023

Fresenius Medical Care Deutschland GmbH

LU504789

Known algorithms or mathematical models from the state of the art (statistical evaluation or regression analysis of historical data and/or neural networks) can be used to calculate such optimized prescriptions. Such optimization and the provision of the data thus determined are also covered by the optional

Process step M4 includes.

In process step M5, the (highly) pure water can be mixed in the mixing device 19 - optionally on the basis of the patient parameter(s) obtained in process step M3 or generated and/or stored in process step M4 or the determined and/or optimized recipe - by

Adding various concentrates, for example from the first container 15, or salts, for example from the second container 17, a ready-to-use

Dialysis fluid can be produced. The recipe, i.e. the

Composition of the different components of the

Dialysis fluid can be individually tailored to the

The respective patients to be treated are created based on current patient parameters. Furthermore, in this step, the

To heat dialysis fluid by means of a heating device, in particular to a predetermined temperature, for example to the body temperature of the patient. A

Control device can be provided and programmed accordingly.

In process step M6, 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. To convey the dialysis fluid, conveying means such as pumps or

230013 LU 46 21.07.2023

Fresenius Medical Care Deutschland GmbH

LU504789 or the like, may be provided by the stationary unit 1a and/or by the mobile unit 1b and are encompassed by the present invention.

In process step M7, the mobile unit 1b can then be transported, as a rule, without significant expenditure of force, to the location in, for example, the patient’s home where his treatment, in particular

Renal replacement therapy should take place. For easy

Handling and movement can be optional

Translation means 50, for example, in particular pivotable, rollers, optionally with braking device, and/or at least one handle 61, in particular as described herein, may be provided.

The renal replacement treatment of the patient, which in certain embodiments does not fall within the scope of the present invention, is illustrated by method step M8.

For this purpose, the dialysis fluid from the mobile

Unit 1b or its main reservoir 53, to the patient. The necessary funding or

Components such as pumps, valves,

Line sections or the like can be provided by the mobile unit 1b and are covered by the present invention. The mobile unit can additionally comprise sensors in order to

Treatment to determine and/or monitor patient parameters, such as the patient’s blood pressure, for example as described above. If these

Patient parameters from a predetermined range, the

Concentration of the dialysis fluid during

Renal replacement treatment, for example as described herein, in particular with reference to Fig. 3a.

230013 LU 47 21.07.2023

Fresenius Medical Care Deutschland GmbH

LU504789

After treatment of the patient, used

Dialysis fluid, also referred to herein as dialysate, is returned to an optional dialysate reservoir 63. The necessary conveying means or components, such as

Pumps, valves, line sections or the like can be provided by the mobile unit 1b and are covered by the present invention. This is due to the

Process step M9 is represented.

In method step M10, the mobile unit 1b is returned/driven back to the stationary unit 1a and reconnected there.

In process step M11, the dialysate is pumped via the stationary

Unit la and the drain line 11, for example, in the

Water drain 13 e.g. from the patient's apartment.

The conveying means or components required for this purpose, such as pumps, valves, line sections or the like, can be provided by the stationary unit 1a and/or by the mobile unit 1b.

In process step M12, rinsing and/or

Disinfection of the fixed unit la and/or the mobile

Unit 1b should be provided. Loading a

Voltage source of the mobile unit 1b by means of a

Power connection 25c, 25d to the stationary unit la can be provided in this step.

It may be necessary to install the fixed unit la on site and

To be left in place and to be used for the next treatment session of the

Patient P to begin the procedure in step M2.

230013 LU 48 21.07.2023

Fresenius Medical Care Deutschland GmbH

LU504789

The above method steps can be carried out one after the other, e.g. in the order mentioned here, and they can follow one another and/or overlap. Since not all method steps disclosed here have to be carried out according to the invention, further processes covered by the present disclosure also result in a modification of the disclosure of Fig. 4, which also fall under the present invention.

230013 LU 49 21.07.2023

Fresenius Medical Care Deutschland GmbH

LU504789

List of reference symbols 1 medical treatment device;

Blood treatment device la stationary unit 1b mobile unit 3a housing of the stationary unit 3b housing of the mobile unit 5 (domestic) water source; water tap 7 water inlet pipe 9 water purification device 11 drain pipe 13 (domestic) water outlet; wash basin first container, e.g. for concentrate 15 17 second container, e.g. for salts 19 mixing device 21 connection for dialysis fluid line 23 connection for dialysate line 25 (domestic) power supply 25a power connection cable 25b mobile power supply; battery 25c power connection 25d power connection 27 dialysis fluid line; first connection between stationary unit and mobile unit 29 dialysate line; second connection between stationary

unit and mobile unit

Water tap 31 Dialysis fluid supply line to the patient 30 32 Dialysate drain line from the patient 33 Patient connection line

Sensor 37 Weighing device; scale

230013 LU 50 21.07.2023

Fresenius Medical Care Deutschland GmbH

LU504789 39 Handle 39a Electrode, contact 41 Communication unit 43 External unit(s); network; cloud 45 User interface 45a Holder/connector for LCD, tablet 45b Holder/connector for LCD, tablet 49 Recesses/rails 50 Translation means; rollers 51 Loudspeaker 53 Main reservoir 53a Secondary reservoir 55 Inflow valves; connection for the

Dialysis fluid supply line to the patient 57 Drain valve; connection for the dialysate drain line from the patient 61 Handle 63 Dialysate reservoir 70 Heating device 100 System

A Viewing direction in Fig. 3a

P Patient

Claims (28)

230013 LU 51 21.07.2023 Fresenius Medical Care Deutschland GmbH LU504789 Claims 1. Medical treatment device (1) comprising - a stationary unit (la) connectable, e.g. by means of a water supply line (7) with a, e.g. stationary or domestic, water source (5) and/or by means of a drain line (11) with a, e.g. stationary or domestic, water drain (13) for the disposal of dialysate, and comprising a mixing device (19), configured to produce dialysis fluid for treating a patient (P); and - a mobile unit (1b) which can be separated from the stationary unit (1a), configured to subject the patient (P) to a treatment, in particular renal replacement treatment, wherein the mobile unit (1b) has at least one of the lines from the group consisting of dialysis fluid supply line (31) to the patient, dialysate drain line (32) from the patient and patient connection line (33) for connection to the patient, and/or a connector for connecting this line to the mobile unit (1b); wherein the stationary unit (1a) and the mobile unit (1b) have connections (27, 29) in order to be fluidically connected to one another. 230013 LU 52 July 21, 2023 Fresenius Medical Care Deutschland GmbH LU504789 2. Medical treatment device (1) according to claim 1, wherein the stationary unit (la) further comprises or is connected to - a water purification device (9); - a water supply line (7) for connection to a stationary water supply (5); - a drain line (11) for disposal of liquid via a, e.g., domestic water drain; and/or - at least one container (15, 17) for dialysis fluid concentrate. 3. Medical treatment device (1) according to one of the preceding claims, wherein the mobile unit (1b) has translation means (50) and/or at least one handle (61). 4. Medical treatment device (1) according to one of the preceding claims, wherein the stationary unit (1a) and/or the mobile unit (1b) have at least one sensor (35, 37, 39a) for determining at least one patient parameter. 5. Medical treatment device (1) according to one of the preceding claims, wherein the stationary unit (la) and/or the mobile unit (1b) have at least one communication unit in order to exchange data with one or more units (43) external to the medical treatment device (1). 230013 LU 53 21.07.2023 Fresenius Medical Care Deutschland GmbH LU504789 to exchange and/or initiate the processing of data on the external unit. 6. Medical treatment device (1) according to one of claims 4 to 5, wherein the mixing device (19) is configured to initiate the mixing of the dialysis fluid on the basis of the previously determined or recorded patient parameter(s) or based on data received from one or more of the external units (43). 7. Medical treatment device (1) according to one of the preceding claims, wherein the stationary unit (1a) is configured to heat the dialysis fluid by means of a heating device (70), in particular to a predetermined temperature. 8. Medical treatment device (1) according to one of the preceding claims, further comprising at least one conveying device configured to convey liquids between the stationary unit (1a) and the mobile unit (1b), optionally in both directions. 9. Medical treatment device (1) according to one of the preceding claims, wherein the stationary unit (1a) and/or the mobile unit (1b) further comprises at least one user interface (45) configured to control or regulate the medical treatment device (1) or at least one of its components, in particular by means of a handheld communication device of the patient (P) or another person. 230013 LU 54 July 21, 2023 Fresenius Medical Care Deutschland GmbH LU504789 10. Medical treatment device (1) according to claim 9, wherein the user interface is further configured to input and/or output further patient parameters and/or to authenticate the patient P or a user. 11. Medical treatment device (1) according to one of claims 2 to 10, wherein the water purification device (9) consists of a reverse osmosis and/or a filter device. 12. Medical treatment device (1) according to one of the preceding claims, wherein the mobile unit (1b) has a mobile power supply (25b), in particular a battery or a rechargeable battery. 13. Medical treatment device (1) according to claim 12, further comprising a power connection (25a, 25c, 25d), by means of which the mobile power supply (25b) of the mobile unit (1b) is charged via the stationary unit (1a). 14. Medical treatment device (1) according to one of claims 4 to 13, configured to adapt the formulation of the dialysis fluid in the mobile unit (1b) based on the patient parameters determined during the treatment of the patient (P). 15. System (100) comprising a medical treatment device (1) according to one of claims 1 to 14, a water source (5), a water drain (13) 230013 LU 55 21.07.2023 Fresenius Medical Care Deutschland GmbH LU504789 and/or a power connection (25) and/or an external unit (43). 16. System (100) according to claim 15, further comprising a dialysis fluid supply line (31) and/or a dialysate drain line (32), which may have a patient connection line (33) as a common section, and which are designed to be able to be connected to a patient P for the purpose of medical treatment. 17. Method for preparing a medical treatment device (1) for an upcoming treatment, in particular blood treatment of a patient (P), comprising the steps: - providing a medical treatment device (1) according to one of claims 1 to 14; - connecting, while achieving a fluid connection, the stationary unit (1a) - to a, e.g. stationary or domestic, water source (5), e.g. by means of a water supply line (7); and/or - to a, e.g. stationary or domestic, water drain (13), e.g. by means of a drain line (11); or ensuring that such a fluid connection exists; 230013 LU 56 July 21, 2023 Fresenius Medical Care Deutschland GmbH LU504789 - Mixing, by means of the mixing device (19) of the stationary unit (la), dialysis fluid for use in the treatment of the patient (P); - optionally: heating the dialysis fluid, preferably to a predetermined temperature; - transferring, by means of a dialysis fluid line (27), the mixed and/or dialysis fluid heated, e.g. to a predetermined temperature, from the stationary unit (la) into a preferably thermally insulated reservoir or main reservoir (53) of the mobile unit (1b); and - moving, e.g. rolling, the mobile unit (1b) to the location of the upcoming treatment of the patient (P). 18. The method according to claim 17, further comprising: - separating the fluid connection between the stationary unit (1a) and the mobile unit (1b) by means of the dialysis fluid line (27) before bringing the mobile unit (1b) to the location of the upcoming treatment of the patient (P). 19. Method according to claim 17 or 18, further comprising: - cleaning water by means of the water purification device (9) of the stationary 230013 LU 57 21.07.2023 Fresenius Medical Care Deutschland GmbH LU504789 Unit (la) before mixing the dialysis fluid. 20. Method according to one of claims 17 to 19, further comprising: - merging, after completion of the treatment of the patient (P), the stationary unit (la) with the mobile unit (1b), establishing a renewed fluid connection between the two units (la, 1b) by means of the dialysis fluid line (27) and/or by means of the dialysate line (29) and exchanging dialysis fluid and/or dialysate between the stationary unit (la) and the mobile unit (1b) using the renewed fluid connection. 21. Method according to one of claims 17 to 20, further comprising: - connecting the mobile unit (1b) to at least one of the lines from the group consisting of dialysis fluid supply line (31) to the patient, dialysate drain line (32) from the patient and patient connection line (33) for connection to the patient in preparation for the upcoming treatment of the patient. 22. Method according to one of claims 17 to 21, further comprising: - determining or detecting at least one patient parameter by means of a sensor (35, 37, 39a) of the stationary unit (la) 230013 LU 58 July 21, 2023 Fresenius Medical Care Deutschland GmbH LU504789 23. Method according to claim 22, wherein the mixing of the dialysis fluid by means of the mixing device (19) of the stationary unit (1a) is carried out on the basis of the previously determined or recorded patient parameter(s). 24. Method according to one of claims 20 to 23, further comprising: - conveying the dialysate by means of the renewed fluid connection via the stationary unit (la) and the drain line (11) into the, e.g. domestic, water drain (13). 25. Method according to one of claims 17 to 24, further comprising: - charging a mobile power supply (25b) of the mobile unit (1b) by means of a power connection (25a, 25c, 25d) of or to the stationary unit (1a). 26. Method according to one of claims 17 to 25, further comprising: - treating the patient (P) by means of the mobile unit (1b) while the latter is fluidically and/or spatially separated from the stationary unit (la). 27. The method according to any one of claims 17 to 26, further comprising: 230013 LU 59 21.07.2023 Fresenius Medical Care Deutschland GmbH LU504789 - Monitoring patient parameters during treatment of the patient (P), using sensors provided for this purpose on or in the mobile unit (1b). 28. Method according to one of claims 17 to 27, further comprising: - adjusting the formulation of the dialysis fluid in the mobile unit (1b) and changing the dialysis fluid based on the patient parameters determined during the treatment of the patient (P).