Medical treatment device, system and method for preparing and following-up on the treatment of a patient
Patent Information
- Authority / Receiving Office
- EP · EP
- Patent Type
- Applications
- Current Assignee / Owner
- FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH
- Filing Date
- 2024-07-24
- Publication Date
- 2026-06-03
AI Technical Summary
Current medical treatment systems for dialysis, particularly for patients with renal issues, are limited by the need for frequent hospital visits and complex logistics for dialysis fluid delivery, which can be burdensome and inefficient, and do not allow for individualized treatment based on patient parameters.
A medical treatment device and system comprising a stationary unit connected to a water source and a mobile unit, enabling the preparation and administration of dialysis fluid at the patient's location, with features like fluid management, heating, and patient parameter monitoring, allowing for individualized dialysis fluid recipes and reduced logistical burdens.
This solution simplifies the treatment process, reduces logistical efforts for patients and caregivers, allows for more frequent and personalized dialysis treatments, and enhances patient safety through automated and efficient preparation and delivery of dialysis fluid.
Smart Images

Figure EP2024071013_30012025_PF_FP_ABST
Abstract
Description
[0001] Description
[0002] Medical treatment device, system and method for preparing and following up on a patient's treatment
[0003] 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.
[0004] Medical treatment devices such as those belonging to the present invention can in particular be blood treatment devices.
[0005] Blood treatment devices also include dialysis machines, which in turn can be divided into at least hemodialysis machines and machines for performing automated peritoneal dialysis.
[0006] Dialysis is a procedure for purifying the blood of patients with acute or chronic renal insufficiency. A basic distinction is made between 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.
[0007] During hemodialysis, 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. During hemofiltration, ultrafiltrate is removed from the patient's blood by applying transmembrane pressure in the dialyzer, without dialysis fluid being passed past the side of the dialyzer membrane opposite or facing away from the patient's blood. In addition, a sterile and pyrogen-free substitute, preferably in the form of a solution, can be added to the patient's blood. The process is referred to as pre-dilution or post-dilution depending on whether this substitute is added upstream or downstream of the dialyzer. The exchange of substances in hemofiltration is convective.
[0008] Hemodialysis filtration combines the processes of hemodialysis and hemofiltration. It involves both a diffusive exchange of substances between the patient's blood and the dialysis fluid across the semipermeable membrane of a dialyzer, and the filtration of plasma water through a pressure gradient across the dialyzer membrane.
[0009] In peritoneal dialysis, a patient's abdominal cavity is filled with dialysis fluid via a catheter passed through the abdominal wall. This fluid has a concentration gradient compared to the body's own fluids. Toxins present in the body pass into the abdominal cavity via the peritoneum, which acts as a membrane. After a few hours, the now used dialysis fluid in the patient's abdominal cavity, which is also referred to herein as dialysate, is replaced. Through osmotic processes, water from the patient's blood can also pass through the peritoneum into the dialysis fluid, thus dehydrating the patient.
[0010] Dialysis procedures are generally carried out using automatic dialysis machines, such as those marketed by the applicant under the designation 5008 or, for peritoneal dialysis, sleep. safe or S ILENCIA.
[0011] An object of the present invention is to provide a further medical treatment device and a system.
[0012] Furthermore, a method is to be specified for preparing a medical treatment device for an upcoming treatment of a patient.
[0013] The object of the invention can be achieved by a medical treatment device having the features of claim 1 and by a system having the features of claim 13. Furthermore, it can be achieved by a method having the features of claim 15.
[0014] According to the invention, a medical treatment device is proposed, comprising or consisting of a stationary unit and a mobile unit which can be separated from the stationary unit.
[0015] The stationary unit is connectable or connected to a water source, for example, via a water supply line. The water source may be immobile or stationary, also referred to herein as "domestic." It may be part of the supply system of the location where the patient's treatment is to be conducted, for example, the patient's home or a clinic. It may be a separate and / or external water tank. The connection may be via a faucet connection or by other means.
[0016] Alternatively or additionally, the stationary unit for the disposal of dialysate, i.e. used dialysis fluid, can be connected or is connected to a water drain, e.g. a stationary or domestic one, for example by means of a drain line.
[0017] Water supply line and / or drain line can be included in the fixed unit, connected to it, etc.
[0018] The stationary unit further comprises a mixing device configured or provided for producing dialysis fluid for treating the patient. Producing the dialysis fluid may involve heating it, for example, to the patient's body temperature, to a predetermined operating temperature, to a temperature above the aforementioned temperatures, etc.
[0019] The mobile unit is designed to provide treatment to the patient, particularly renal replacement therapy. It can be used separately from the stationary unit for this purpose.
[0020] 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 necessary connector(s) for connecting this line to the mobile unit, or is connected thereto.
[0021] 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, i.e. in order to be able to exchange fluids, in particular liquids such as dialysis fluid, dialysate and / or the like, between them.
[0022] The system according to the invention comprises a medical treatment device according to the invention, a water source, e.g., a faucet, a water drain, e.g., a sink, and / or a power connection or voltage source, e.g., for supplying the medical treatment device with electrical voltage. The water source, water drain, and / or power connection / voltage source can be, for example, stationary and / or "domestic" structures.
[0023] 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:
[0024] Providing a medical treatment device according to the invention;
[0025] Connecting the stationary unit to a water source, e.g. stationary or domestic, which is done e.g. by means of a water supply line, whereby a fluid connection between the water source and the stationary unit is effected or prepared, and / or
[0026] Connecting the stationary unit to a, e.g., stationary or domestic, water drain, whereby a fluid connection between the water drain and the stationary unit is created or prepared, for which purpose, e.g., a drain line can be used, if one is provided.
[0027] The above connection steps can be omitted if such a connection already exists.
[0028] Optionally, the system according to the invention further comprises one or more of the following steps:
[0029] Mixing dialysis fluid for use in treating 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;
[0030] Transferring 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
[0031] Moving, e.g. pulling, pushing, rolling, etc., the mobile unit to the location where the patient is to be treated.
[0032] The place of the upcoming treatment can be a place specified by the patient in the house, apartment or home (in short: residence) of the patient to be treated, where the patient wishes to undergo the treatment.
[0033] 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.
[0034] In all statements made above and in all 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 of the invention.
[0035] Whenever numerical words are mentioned herein, the person skilled in the art will understand this as indicating a numerical lower limit. Unless this leads to a contradiction recognizable to the person skilled in the art, the person skilled in the art will therefore always read the reference to "a" or "an" as "at least one" or "at least one". This understanding is also encompassed by the present invention, as is the interpretation that a numerical word such as "a" can alternatively be meant as "exactly one", wherever this is recognizably technically possible for the person skilled in the art. Both are encompassed by the present invention and apply to all numerical words used herein.
[0036] Whenever spatial information is mentioned herein, such as "above", "below", "left" or "right", the person skilled in the art will understand this to refer to the arrangement in the figures attached here and / or in the state of use. "Below" is closer to the center of the earth or the lower edge of the figure than "above". When a "patient" is mentioned herein, this refers to a person who requires treatment. This notation does not provide any information as to the gender or other characteristics of this person.
[0037] When reference is made here to a "user," this refers to a patient or a person who is not in need of treatment, such as medical personnel, caregivers, or the like. The term "user" does not provide any information about the gender or other characteristics of this person.
[0038] When reference is made herein to a "home" or "inpatient" device, this means that this device is provided where the patient wishes to undergo or have his treatment 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 doctor's office or another medical facility. In some embodiments, the home may be different from a clinic, a doctor's office or other medical facility; in others, the terms "home" or "inpatient" also include such devices.
[0039] When reference is made herein to a "stationary unit", this means that the unit is not and does not need to be moved, driven, shifted, relocated or in any way changed in its position during its use, during the treatment or treatment session. This can be due, for example, to the fact that it is and / or becomes and / or remains connected to stationary sources (water supply, electricity or the like). A stationary unit can also be or be referred to herein as a first unit. The terms "stationary unit" and "first unit" are interchangeable in some embodiments herein.
[0040] When reference is made herein to a "mobile unit", this means that the unit is typically moved, driven, shifted, repositioned or changed in some way during or for use in the patient's care, e.g., for the upcoming treatment of the patient. Changing the position may be facilitated by devices, for example, translation means such as rollers and / or handles. A mobile unit may also be or be referred to herein as a second unit. The terms "mobile unit" and "second unit" are interchangeable in some embodiments.
[0041] Advantageous further developments of the present invention are the subject of subclaims and embodiments.
[0042] When an embodiment is mentioned herein, it represents an exemplary embodiment of the invention and is not to be understood as limiting.
[0043] If it is disclosed herein that the subject matter according to the invention has one or more features in a particular embodiment, it is also disclosed herein that the subject matter according to the invention expressly does not have precisely this or these features in other, likewise inventive embodiments, e.g., by way of a disclaimer. Thus, for each embodiment mentioned herein, the opposite embodiment, formulated, for example, as a negation, is also disclosed.
[0044] 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 carryable 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 thereto in a signal connection.
[0045] When reference is made to programmed, set up or configured, these terms may be interchangeable in some embodiments.
[0046] If 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 while a treatment has not yet begun or has already ended. Optionally, the method steps described herein are carried out in the order stated herein, in a temporally overlapping manner, or simultaneously.
[0047] The treatment of the patient can be completed or not yet started while, for example, the patient is not connected to the blood treatment device, for example 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.
[0048] In some embodiments of the medical treatment device according to the invention, the stationary unit and the mobile unit each have terminals for electrically connecting them to one another.
[0049] In some embodiments, the stationary unit of the medical treatment device according to the invention comprises or is connected to a water purification device.
[0050] In some embodiments, the stationary unit includes or is connected to a water supply line for connecting it to a stationary water source or water supply.
[0051] In some embodiments, the stationary unit has or is connected to a drain line for disposing of fluid, e.g., dialysate, via a water drain, e.g., a domestic one. In some embodiments, the stationary unit has or is connected to at least one container for storing dialysis fluid concentrate.
[0052] In some embodiments of the medical treatment device according to the invention, the mobile unit has translation means and / or at least one handle.
[0053] 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.
[0054] In some embodiments, the handle may be provided and configured for carrying or lifting the mobile unit; in some embodiments, for pulling and / or pushing, and in some embodiments, for both. The handle may, for example, be provided in a side or top area of the mobile unit. Any number of handles and any suitable position of a handle are encompassed by the present invention.
[0055] In some embodiments, 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. Such reservoirs are in particular not flexible film bags, which are known for hanging or placing on peritoneal dialysis devices. Such reservoirs are preferably provided in an interior, e.g., within a housing of the mobile unit. They can be hidden from the viewer's eye without opening or disassembling the mobile unit.
[0056] In certain embodiments, the reservoir or main reservoir and / or any other reservoir of the mobile unit may be insulated, for example, similar to a thermos flask. This advantageously eliminates the need for an additional heating device (with the associated higher power consumption, risk of electrical voltage, risk of tripping over a power cable, with the advantage of being independent of the nearest power outlet, etc.) in the mobile unit.
[0057] In some embodiments, 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 premises or is or will not be connected to this.
[0058] In some embodiments, the stationary unit and / or the mobile unit comprise at least one sensor for determining at least one patient parameter (or current value thereof).
[0059] Determining or determining, in particular of data and / or values, can be or include investigating an existence or non-existence, capturing, recording, measuring, collecting, evaluating, processing, comparing, estimating, assessing or estimating, deducing, calculating, obtaining, achieving and / or recognizing.
[0060] Using such a sensor, in some
[0061] In some embodiments, the patient's glucose level or the like is being determined. Turbidimeter methods can be used for these or other measurements.
[0062] In certain embodiments, a turbidimetric sensor may 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 detect its composition.
[0063] In some embodiments, such a sensor is optionally a device for determining the patient's bioimpedance (BCM). For this purpose, movable or fixed structures, such as handles, with contacts, for example, on the left and right sides of the housing of the stationary unit, can be provided, which enable a signal to be coupled into the patient, e.g., to determine the degree of overhydration to be treated.
[0064] In some embodiments, such sensors can be integrated 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 encompassed by the invention.
[0065] Optionally, in some embodiments, sensors are provided, for example to measure 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. In some embodiments of the medical treatment device according to the invention, 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 devices, 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.
[0066] Communication units are known to those skilled in the art. Communication units and the corresponding technology from the prior art can be used here, e.g., peer-to-peer via Bluetooth, communication with a local area network (LAN) or a wide-area network (WAN), or the like.
[0067] When reference is made herein to a signal or communication connection between two components, this may be understood as a connection that is already in use. It may also be understood as preparation for such a signal connection (wired, wireless, or implemented in another way), for example, by coupling the two components, such as by pairing, etc.
[0068] Pairing is a process that occurs in computer networks to establish an initial connection between computer units for the purpose of communication. The best-known example is establishing a Bluetooth connection, which connects different devices (e.g., smartphones, headphones). Pairing is sometimes also referred to as bonding.
[0069] In some embodiments of the medical treatment device, 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).
[0070] In some embodiments, the mixing device is configured to initiate the mixing of the dialysis fluid based on data received from one or more of the external units. This transmitted data may be stored raw data of the patient parameters and / or further processed data, for example, resulting in a determined and / or optimized formulation (for adding various concentrates to ultrapure water) for the dialysis fluid.
[0071] In certain embodiments, the stationary unit is configured to heat the dialysis fluid by means of a heating device, in particular to a predetermined temperature. It may comprise such a device.
[0072] In some embodiments, the medical treatment device has or is connected to at least one conveying device. In these embodiments, the conveying device is configured to convey liquids between the stationary unit and the mobile unit, optionally in both directions. In some embodiments, 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. In particular, 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.
[0073] 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. 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, may be provided and are encompassed by the present invention.
[0074] In some embodiments, the water purification device consists of or comprises a reverse osmosis and / or a filter device.
[0075] In certain embodiments, the stationary 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. In some embodiments, the mobile unit has a mobile power supply, in particular a battery or accumulator.
[0076] In some embodiments, 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.
[0077] In some embodiments, the medical treatment device is configured to adjust the formulation of the dialysis fluid in the mobile unit based on patient parameters determined during treatment of the patient.
[0078] The patient parameters determined during patient treatment may, 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. The necessary devices (keyboard, microphone, camera, and / or the like) may be provided and are encompassed by the present invention.
[0079] In some embodiments, the system according to the invention comprises a dialysis fluid inlet line and / or a dialysate outlet 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 body cavity or a vessel of the patient for the purpose of medical treatment. In some embodiments of the method according to the invention, this further comprises severing the fluid connection existing between the stationary unit and the mobile unit by means of the dialysis fluid line. This occurs before the mobile unit is moved to the location of the upcoming patient treatment.
[0080] 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, using a combination of filters and a reverse osmosis system, particularly to obtain pure or ultrapure water.
[0081] In some embodiments, the method includes merging the mobile unit with the stationary unit after completion of treatment of the patient.
[0082] In some embodiments, 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.
[0083] 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 line for connection to the patient in preparation for the upcoming treatment of the patient.
[0084] In some embodiments, the method includes connecting the power cable of the fixed unit to the power supply.
[0085] In some embodiments, 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.
[0086] 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.
[0087] In some embodiments, the method comprises determining a formulation for a dialysis fluid suitable for the patient to be treated or optimizing the same.
[0088] In some embodiments, the method comprises mixing the dialysis fluid using the mixing device of the stationary unit based on or taking into account the previously determined or recorded patient parameter(s). Mixing is performed from (highly) pure water by adding one or more concentrates.
[0089] In some embodiments, the method comprises
[0090] The dialysis fluid is mixed 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 formulation. Mixing is also carried out using (highly) pure water by adding one or more concentrates.
[0091] In certain embodiments, 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.
[0092] In some embodiments, the method comprises conveying 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.
[0093] In some embodiments, the method comprises charging a mobile power supply of the mobile unit by means of a power connection of or to the stationary unit.
[0094] In some embodiments, the method includes flushing the stationary unit and / or the mobile unit.
[0095] In some embodiments, the method includes disinfecting the fixed unit and / or the mobile unit.
[0096] In some embodiments, the method comprises treating the patient by means of the mobile unit while the mobile unit is fluidically and / or spatially separated from the stationary unit.
[0097] In some embodiments, the method comprises monitoring patient parameters by means of sensors provided for this purpose on or in the mobile unit during treatment of the patient.
[0098] In some embodiments, the method comprises adapting 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.
[0099] 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 required for control or regulation.
[0100] The control device can initiate the execution of all or substantially all 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. 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.
[0101] In some embodiments, the control device is located either in the mobile unit or in the stationary unit. In other embodiments, one control device is located in the mobile unit and one in the stationary unit. In the latter
[0102] In some embodiments, these control devices may optionally be in contact with each other via a communication unit or signal connection.
[0103] In some embodiments of the method, this may include preparing the medical treatment device in advance, e.g., for treatment the next day.
[0104] In some embodiments of the method, this does not include connecting or preparing or holding bags of dialysis fluid, e.g. in the form of flexible or foil bags.
[0105] In some embodiments, 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
[0106] Designed for renal replacement therapy or continuous kidney replacement therapy (CKRT). In some embodiments, 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 that is introduced into the peritoneum as part of a so-called final enema shortly before the end of the treatment session, where it is allowed to remain. This reservoir can be accessed via the same valve as the main reservoir, or via a different, second valve.
[0107] The mobile unit or its internal / external containers, such as the main reservoir or other reservoirs, can be cleaned, 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. In some embodiments, it is provided to provide the user with a button, e.g. on a touchscreen, a hard key such as a switch, for example a rotary knob, a toggle switch or the like for its operation.If the user activates this switch, button or the like, the cleaning and / or emptying program starts, either immediately or with a time delay, e.g. at a time entered by the user or specified by default, or after the expiry of a time period entered by the user or specified by default. It can be provided that one or more monitoring steps run before the start of the cleaning and / or emptying program. For example, the medical treatment device, the mobile unit and / or the stationary unit can be programmed to first check conditions such as whether the required connection status exists between the mobile unit and the stationary unit, between one of the units and a cast, and the like. Warnings, instructions and requests, with or without confirmation from the user, can be displayed and / or require confirmation with reference to these conditions, etc.
[0108] In certain embodiments, the medical treatment device, the mobile unit and / or the stationary unit or corresponding control devices thereof are programmed or are triggered externally, e.g. via a network, the cloud, etc., to automatically start or initiate the cleaning and / or emptying program, in whole or in part, or only selected steps thereof. This can be triggered by reaching predetermined times, the expiration of predetermined periods of time, reaching a predetermined number of treatment sessions carried out using the treatment device, or similar. For example, it can be provided that 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 remaining emptying, which may be necessary beforehand, for example of the main reservoir of the mobile unit.
[0109] For cleaning, heating of cleaning fluid, a
[0110] This includes the inflow and outflow of cleaning fluid into the internal / external containers such as the main reservoir or other reservoirs of the mobile unit, etc.
[0111] Since 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.
[0112] Some or all embodiments of the invention may have one, several or all of the advantages mentioned above and / or below.
[0113] Peritoneal dialysis can offer the advantage of eliminating frequent travel between home and treatment. The time saved and the reduced effort compared to inpatient treatment of critically ill patients can also positively influence the patient's perceived mental stress, allowing treatment goals to be achieved more frequently and sustainably.
[0114] By means of the present invention, the preparation, control and programming of the medical treatment device can advantageously be made more convenient and flexible.
[0115] A further advantage of the present invention may be that comprehensive information about the patient, including information about their home environment and their treatment, can be obtained. This information can, for example, be evaluated and stored over time to make the patient's treatment even more individualized and thus safer and more tolerable. In addition, the patient's feedback, for example, through direct communication with a doctor or medical staff, can contribute to patient safety.
[0116] 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.
[0117] 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.
[0118] 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.
[0119] 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. precise measurement of overhydration using bioimpedance, and on the other hand individual mixing of the dialysis fluid is possible in the patient's home environment, based on an appropriately designed algorithm which can generate an individualized treatment for a patient on the basis of the recorded patient parameters. 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.
[0120] By means of the present invention, the provision of dialysis fluid suitable for treatment can be carried out in advance, for example, the day before. This can represent a further advantage.
[0121] Advantageously, the present invention can considerably simplify the workflow for medical personnel.
[0122] A further advantage of the present invention may be that the method according to the invention can be largely automated, i.e., without human intervention. This can help save personnel expenditure, i.e., labor time and costs.
[0123] By using a dialysis fluid formulation that is individually optimized and / or perfectly tailored to the patient being treated, patient tolerance of the treatment and the medical outcome can be indirectly improved.
[0124] The present invention advantageously provides a common machine platform for the clinical and private environments. This can contribute to increasing time and cost efficiency and / or enabling development, updates, etc., to be used universally across multiple machine types, thus saving resources. With regard to enhanced user guidance, data can also 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 also patient safety can be increased.
[0125] All advantages achievable with the method according to the invention can also be achieved without reduction with the devices according to the invention in certain embodiments of the invention, and vice versa.
[0126] 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:
[0127] Fig. 1 shows a schematically simplified representation of a system according to the invention in a first embodiment;
[0128] Fig. 1a shows the mobile unit of the system of Fig. 1 during renal replacement treatment of a patient P;
[0129] 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;
[0130] Fig. 3 shows a simplified schematic view of a mobile unit of a system according to the invention in a further
[0131] Design form from the outside in perspective view;
[0132] 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.
[0133] Fig. 1 shows a highly simplified schematic representation of a system 100 according to the invention in a first embodiment.
[0134] 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.
[0135] The stationary unit 1a is designed to be connected to a (domestic) water source 5 by means of a water inlet line 7, a faucet in the present example of Fig. 1. Additionally, it is designed to be connected to a (domestic) water outlet 13, a sink in the example of Fig. 1, by means of a drain line 11. For this purpose, corresponding line or water connections can be provided on the stationary unit 1a or on lines thereof and / or on the water source 5 or the water outlet 13.
[0136] Furthermore, 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.
[0137] 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. For this purpose, corresponding connectors can be provided on the stationary unit 1a and / or on the mobile unit 1b or on lines thereof. The connection thus established is intended in particular to conduct or pump fluid(s), for example dialysis fluid, from the stationary unit 1a to the mobile unit 1b, and vice versa, for example dialysate, from the mobile unit 1b to the stationary unit 1a.
[0138] In some embodiments, 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 for charging an optional mobile power supply 25b (see Fig. 3a), e.g. a battery, of the mobile unit 1b.
[0139] 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.
[0140] The stationary unit 1a and / or mobile unit 1b can each have a communication unit 41 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
[0141] Place, as shown in Fig. 1, or be integrated into the respective unit 1a, 1b. 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.
[0142] For this purpose, 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, 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.
[0143] In order to enable a change of location of the mobile unit 1b as easily and as frictionlessly as possible, translation means 50, in particular (pivoting and / or lockable) rollers, and / or at least one handle 61 can be provided. The handle 61 can in some
[0144] In some embodiments, the mobile unit may be provided for carrying or lifting, in others for pulling and / or pushing, and in yet other embodiments for both. In the example in Fig. 1, a handle 61 is provided on the side of the mobile unit 1b, while in other embodiments it is provided in an upper region. Both the number and the position of the handle 61 are purely exemplary and are not to be understood as restrictive. Any number of handles 61 and any positions thereof on the mobile unit 1b are encompassed by the present invention.
[0145] Patient P can thus sit at a location convenient for him and undergo renal replacement treatment there, provided this location offers sufficient space for the mobile unit 1b of the system 100. He is not forced to undergo 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 performed may well be spatially limited, since only the mobile unit 1b, not the entire system 100, needs to fit there.
[0146] 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.
[0147] For a more detailed description of the treatment, please refer to the description in Fig. 4 to avoid repetition.
[0148] Fig. 2 shows a schematically simplified view of the stationary unit 1a of the system 100 according to the invention in a further embodiment to illustrate its internal structure.
[0149] The stationary unit 1a 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.
[0150] In the example of Fig. 2, the stationary unit 1a 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 patient's glucose level or the like could be determined. For these or other measurements, turbidimetric methods with appropriate sensors can be used.
[0151] For patient parameter recording, the stationary unit 1a in the example of Fig. 2 optionally has a device for determining the patient's bioimpedance (BCM). For this purpose, 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 overhydration to be treated.
[0152] 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.
[0153] Optional sensors are provided to measure a patient's blood pressure, for example, using a cuff, radar, or an optical measurement using pulse wave analysis.
[0154] 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. Since a relatively high level 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 which is configured, programmed or prepared to have a signal connection to the external unit 43, for example a network, an external, remote server or a cloud. The signal connection can be provided / programmed / suitable for unidirectional or bidirectional transfer of data. For this purpose, the communication unit 41 can be used in any way known in the prior art (e.g.Ethernet, Wi-Fi, Bluetooth, 5G, etc.).
[0155] The aggregated patient parameters, patient data, or data, e.g., the degree of overhydration, blood pressure, and / or the patient's weight, 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. In this case, further data, e.g., treatment data, can also be used to determine a suitable or optimized formulation for the dialysis fluid for the treatment of a patient P (not shown in Fig. 2) and to provide it for an upcoming treatment or treatment session.
[0156] The following example is given: If, for example, it can be determined that both the patient's weight and overhydration have increased over a period of several weeks, the recipe can be adjusted so that a more concentrated dialysis fluid is mixed and / or the frequency or duration of treatment is increased.
[0157] 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.
[0158] The stationary unit 1a 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 impurities by means of the water purification device 9, for example by a combination of filters (e.g. activated carbon filters) and a reverse osmosis system (RO system), in order to ultimately obtain pure or ultra-pure water that can be used for the renal replacement treatment of the patient P.
[0159] In the system 100, here e.g. in or on the housing 3a of the stationary unit 1a, at least one container for dialysis fluid concentrate (herein also referred to as concentrate) and / or salts is also provided. 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 positions in the system 100, for example in or on the housing 3a or outside thereof, are also encompassed by the present invention.
[0160] An optional mixing device 19 can be made from the (highly) pure
[0161] Water from the water purification device 9, the concentrate from the first container 15, and / or salt from the second container 17 produce dialysis fluid for treating the patient P, for example, his or her renal replacement treatment. This can then be conveyed to or into the mobile unit 1b via a connection 13, e.g., by means of appropriate lines provided for this purpose, as described herein.
[0162] 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 should not be understood as restrictive. Any other position on the housing 3a of the stationary unit 1a is also encompassed by the present invention.
[0163] A water tap 30 or another withdrawal possibility can be provided on the stationary unit 1b as an outlet, for example to supply bags, in particular for CAPD (continuous ambulatory peritoneal dialysis), or a
[0164] Fill the secondary reservoir 53a of the mobile unit 1b (see Fig. 3a) with pure, preferably high-purity, water.
[0165] 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 conduct used dialysate from the mobile unit 1b via corresponding lines toward the water drain 13.
[0166] In any embodiment, 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 pass through the stationary unit 1a. A control device, e.g., of the mobile unit 1b, can optionally be programmed accordingly to carry out or start such disposal at the request of the user, or automatically or semi-automatically.
[0167] The design of the stationary unit 1a has optional recesses 49 or rails in which translation means 50, for example rollers, of the mobile unit 1b, e.g. as described herein, can be accommodated.
[0168] An optional heating device 70 may be provided at the location shown in Fig. 2 or at any other location of the stationary unit 1a.
[0169] Fig. 3 shows a simplified schematic view of the mobile unit 1b of the system 100 according to the invention in a further
[0170] Design form from the outside in perspective view.
[0171] It shows a housing 3b of the mobile unit 1b, which can contain the components described in more detail in the description of Fig. 3a. In the perspective of Fig. 3, in the right-hand side of the housing 3b, as seen from 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 (LCD), in particular that of a tablet, in particular a tablet of the patient or a user, or the like.
[0172] 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.
[0173] Furthermore, the embodiment of Fig. 3 also has, in the left side of the housing 3b as seen from the viewer, one, two or more optional loudspeakers 51 which can, for example, output instructions for operating the medical treatment device 1 according to the invention to the patient or the user.
[0174] On the side of the housing 3b of the mobile unit 1b facing the viewer, 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).
[0175] 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.
[0176] 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 can remain there. This dialysis fluid can differ in terms of composition, osmolarity, etc. from that in the main reservoir 53. Like the main reservoir 53, this reservoir can be designed to be thermally insulating, etc. Instead of two outflow or inflow valves 55, 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. This switching device can therefore optionally be controllable by means of the control device.
[0177] Furthermore, 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).
[0178] The mobile unit 1b preferably stands on translation means 50, e.g. pivotable (represented by a double-headed arrow) and / or lockable rollers, in order to be able 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. Alternatively or additionally, it can have at least one handle 61, the number and position of which in Fig. 3 are also purely exemplary and are not to be understood as limiting.
[0179] The mobile unit 1a can, in turn, be additionally equipped with a communications unit or be prepared for this purpose. This is indicated by a WLAN icon. Everything stated herein regarding communications units can also apply to the communications unit of the mobile unit 1b.
[0180] 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.
[0181] Fig. 3a shows a simplified schematic view 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
[0182] Unit 1a when the mobile unit 1b is fluidically and / or electrically connected to the stationary unit 1b.
[0183] Reference is made to the descriptions of the preceding figures .
[0184] Fig. 3a also shows further components that can be individually and independently comprised by the housing 3b of the mobile unit 1b or arranged thereon. These optional components will be discussed below.
[0185] The mobile unit 1b has a main reservoir 53 and at least one secondary reservoir 53a. The main reservoir 53 can be filled with dialysis fluid 27 by means of the connection 21 shown in Fig. 2 via a dialysis fluid line 27 (indicated as a short line in Fig. 3a), which was previously mixed individually for the patient to be treated in the stationary unit 1a, preferably based on current patient parameters. The secondary reservoir(s) 53a can be or have been filled with, in particular, high-purity water, concentrate and / or salts.
[0186] The main reservoir 53 is fluidically connected to the inflow valve(s) 55. Contents 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.
[0187] To detect the need to adjust the dialysis fluid formulation, the mobile unit can additionally comprise sensors to determine and / or monitor patient parameters, such as the patient's blood pressure, before / during / after treatment, for example, as described herein. If these patient parameters fall outside a predetermined range, the concentration of the dialysis fluid can be adjusted during renal replacement treatment ("on the fly"), for example by adding water, concentrate, or salts from one of the secondary reservoirs 53a.
[0188] As an electrical connection option for the mobile power supply 25b, for example a battery, of the mobile unit 1b, a power connection 25d is shown 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 stationary unit 1a (socket, see Fig. 2). The 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 encompassed by the present invention.
[0189] The mobile unit 1b further comprises a dialysate reservoir 63 which can hold used dialysis fluid, also referred to herein as dialysate, which was conveyed from the patient P to the mobile unit 1b via the drain valve 57 by means of a fluidic connection of the dialysate reservoir 63 to the dialysate drain line 32 (see Fig. 1a). The conveying means required for this purpose can be provided by the mobile unit 1b and are encompassed by the present invention.
[0190] If the mobile unit 1b has been returned to the stationary unit 1a and connected to it, the dialysate can be conveyed from the dialysate reservoir 63 of the mobile unit 1b via the dialysate line 29 (indicated as a short line in Fig. 3a) into the stationary unit 1a and from there, for example, into the water drain 13 (see Fig. 1) and disposed of there.
[0191] 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. In the example of Fig. 3a, the rollers 50 are shown with a view of their running surface, in a position in which they fit into the recesses 49 of the stationary unit 1a (see Fig. 2). Fig. 4 shows, by way of example, a sequence of a method according to the invention that can be carried out by means of the system 100 according to the invention.
[0192] Reference is made to the description and reference symbols of the preceding figures.
[0193] In method step M1, a system 100 according to the invention is provided at the location (house, apartment, home, etc.) of a patient P. The stationary unit 1a is connected by means of a water inlet line 7 to a (domestic) water source 5 for the water supply, which provides, for example, tap water. Furthermore, a drain line 11 of the stationary unit 1a is connected to a domestic water drain 13, for example, a sink or the like, in each case permanently or temporarily, simultaneously or not.
[0194] Since the quality of tap water is generally insufficient for the preparation of dialysis fluid, the tap water can be cleaned or otherwise treated in process step M2, e.g. using a combination of filters (e.g. activated carbon filters) and a reverse osmosis system (RO system), in order to obtain pure or ultrapure water.
[0195] In the optional method step M3, 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.
[0196] Known algorithms or state-of-the-art mathematical models (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 included in the optional process step M4.
[0197] In method step M5, a ready-to-use dialysis fluid can be produced in the mixing device 19 - optionally on the basis of the patient parameter(s) obtained in method step M3 or generated and / or stored from the patient parameter(s) in method step M4 or the determined and / or optimized recipe - from the (highly) pure water by adding various concentrates, for example from the first container 15, or salts, for example from the second container 17. The recipe, i.e. the composition of the various components of the dialysis fluid, can be created individually for the respective patient to be treated based on current daily patient parameters. Furthermore, this step can provide for the dialysis fluid to be heated by means of a heating device, in particular to a predetermined temperature, for example to the patient's body temperature.A control device may be provided and programmed accordingly.
[0198] 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. For conveying the dialysis fluid, conveying means, such as pumps or the like, can be provided by the stationary unit 1a and / or by the mobile unit 1b and are encompassed by the present invention.
[0199] In method step M7, the mobile unit 1b can then generally be transported without significant expenditure of force to the location, e.g., in the patient's home, where the patient's treatment, in particular renal replacement therapy, is to take place. For easy handling or movement, translation means 50, for example, in particular pivoting casters, optionally with a braking device, and / or at least one handle 61, in particular as described herein, can be provided.
[0200] The renal replacement treatment of the patient, which in certain embodiments does not fall within the scope of the present invention, is represented by method step M8. For this purpose, 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 purpose, 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 explained 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 regard to Fig. 3a.
[0201] After the patient's treatment, 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 encompassed by the present invention. This is represented by method step M9.
[0202] In process step MI O, the mobile unit 1b is returned / driven back to the stationary unit 1a and reconnected to it there.
[0203] In method step M11, the dialysate is conveyed via the stationary unit 1a 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 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 method step M12, rinsing and / or disinfection of the stationary unit 1a 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 1a can also be provided in this step.
[0204] It may be provided to leave the stationary unit 1a in place and to start the procedure in process step M2 for the next treatment session of the patient P.
[0205] The above method steps can be carried out consecutively, e.g., in the order stated here, and they can follow one another and / or overlap. Since not all method steps disclosed herein need to be carried out according to the invention, further processes encompassed by the present disclosure also arise in modification of the disclosure of Fig. 4, which also fall within the scope of the present invention.
[0206] List of reference symbols
[0207] I medical treatment device;
[0208] Blood treatment device la fixed unit
[0209] 1b mobile unit
[0210] 3a Housing of the fixed unit
[0211] 3b Housing of the mobile unit
[0212] 5 (domestic) water source; tap
[0213] 7 Water inlet line
[0214] 9 Water purification system
[0215] II Drain line
[0216] 13 (domestic) water drain; sink
[0217] 15 first container, e.g. for concentrate
[0218] 17 second container, e.g. for salts
[0219] 19 Mixing device
[0220] 21 Connection for dialysis fluid line
[0221] 23 Connection for dialysate line
[0222] 25 (domestic) electricity supply
[0223] 25a power cable
[0224] 25b mobile power supply; battery
[0225] 25c power connection
[0226] 25d power connection
[0227] 27 Dialysis fluid line; first connection between stationary unit and mobile unit
[0228] 29 Dialysate line; second connection between fixed unit and mobile unit
[0229] 30 faucet
[0230] 31 Dialysis fluid supply line to the patient
[0231] 32 Dialysate drain line from the patient
[0232] 33 Patient connection line
[0233] 35 Sensor
[0234] 37 Weighing device; scale 39 Handle
[0235] 39a Electrode, contact
[0236] 41 Communication unit
[0237] 43 external unit(s); network; cloud
[0238] 45 User interface
[0239] 45a Holder / connector for LCD, tablet
[0240] 45b Holder / connector for LCD, tablet
[0241] 49 recesses / rails
[0242] 50 translation tools; roles
[0243] 51 speakers
[0244] 53 Main reservoir
[0245] 53a Secondary reservoir
[0246] 55 inlet valves; connection for the
[0247] Dialysis fluid supply line to the patient
[0248] 57 Drain valve; connection for the dialysate drain line from the patient
[0249] 61 handle
[0250] 63 Dialysate reservoir
[0251] 70 Heating device
[0252] 100 systems
[0253] A Viewing direction in Fig. 3a
[0254] P Patient
Claims
Claims 1. Medical treatment device (1) comprising a stationary unit (1a), connectable, for example by means of a water supply line (7) to a, for example stationary or domestic, water source (5) and / or by means of a drain line (11) to a, for examplestationary 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) and is 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) for being fluidically connected to one another; wherein the stationary unit (1a) and / or the mobile unit (1b) has at least one sensor (35, 37, 39a) for. Determining or recording at least one patient parameter, and / or wherein the stationary unit (1a) 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) and / or to initiate the processing of data on the external unit (43); 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 units (43) external to the medical treatment device (1).
2. Medical treatment device (1) according to claim 1, wherein the stationary unit (1a) further comprises or is connected to a water purification device (9); a water inlet line (7) for connection to a stationary water supply (5); a drain line (11) for disposing 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) 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) is configured to heat the dialysis fluid, in particular to a predetermined temperature, by means of a heating device (70).
5. 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.
6. 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.
7. Medical treatment device (1) according to claim 6, 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.
8. Medical treatment device (1) according to one of claims 2 to 7, wherein the Water purification device (9) consists of a reverse osmosis and / or a filter device.
9. 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.
10. Medical treatment device (1) according to claim 9, 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).
11. Medical treatment device (1) according to one of claims 1 to 10, 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).
12. Medical treatment device (1) according to one of the preceding claims, wherein the stationary unit (1a) 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.
13. System (100) comprising a medical treatment device (1) according to one of claims 1 to 12, a water source (5), a water drain (13) and / or a power connection (25) and / or an external unit (43).
14. System (100) according to claim 13, 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 connected to a patient P for the purpose of medical treatment.
15. A 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 12; 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 inlet line (7); and / or to a, e.g., stationary or domestic, water outlet (13), e.g., by means of a drain line (11); or ensuring that such a fluid connection exists; Mixing, by means of the mixing device (19) of the stationary unit (1a), 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, for example, heated to a predetermined temperature, dialysis fluid from the stationary unit (1a) 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); optionally: determining or recording at least one patient parameter by means of a sensor (35, 37, 39a) of the stationary unit (1a); wherein the mixing of the dialysis fluid by means of the mixing device (19) of the stationary unit (1a) takes place on the basis of the previously determined or recorded patient parameter(s) or on the basis of data received from one or more external units (43).
16. The method of claim 15, further comprising: Disconnecting the fluid connection between the stationary unit (1a) and the mobile unit (1b) by means of the dialysis fluid line (27) before moving the mobile unit (1b) to the location of the upcoming treatment of the patient (P).
17. The method of claim 15 or 16, further comprising: Purifying water by means of the water purification device (9) of the stationary unit (1a) before mixing the dialysis fluid.
18. The method according to any one of claims 15 to 17, further comprising: After treatment of the patient (P) has been completed, merging the stationary unit (1a) with the mobile unit (1b), establishing a renewed fluid connection between the two units (1a, 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 (1a) and the mobile unit (1b) using the renewed fluid connection.
19. The method according to any one of claims 15 to 18, 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.
20. The method according to any one of claims 15 to 19, further comprising: Conveying the dialysate by means of the renewed fluid connection via the stationary unit (1a) and the drain line (11) into the, e.g., domestic, water drain (13).
21. The method according to any one of claims 15 to 20, 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 ( la) .
22. The method according to any one of claims 15 to 21, 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 (1a).
23. The method according to any one of claims 15 to 22, further comprising: Monitoring patient parameters during treatment of the patient (P) by means of sensors provided for this purpose on or in the mobile unit (1b).
24. The method according to any one of claims 15 to 23, further comprising: - Adjusting the recipe of the dialysis fluid in the mobile unit (1b) and changing the Dialysis fluid based on the patient parameters determined during patient treatment (P).