Device for ensuring the availability of a batch of dialysis concentrate

Abstract

Device for ensuring the availability of a batch of dialysis concentrate, comprising • a data interface (12) configured to receive information about the remaining quantity of a previously produced dialysis concentrate in a storage tank (20); • a data processing unit (10) which is connected to and configured with the data interface (12) to determine whether the remaining quantity of the already produced dialysis concentrate and any existing reserve of a similar dialysis concentrate is sufficient, • a communication unit (14) which is connected to and configured with the data processing unit (10) to transmit a notification signal indicating that, if available, the reserve of the same dialysis concentrate should be connected and / or that the production of a new batch of the dialysis concentrate should be initiated.

Description

AREA OF INVENTION

[0001] The present invention relates to a device for ensuring the availability of a batch of dialysis concentrate. The invention further relates to a use of this device. The invention lies particularly in the field of planning and controlling supply processes in medical environments to ensure an uninterrupted supply to dialysis treatment machines. BACKGROUND OF THE INVENTION

[0002] In dialysis clinics, dialysis concentrate is often produced centrally in mixing plants, temporarily stored in storage tanks, and then distributed from there to the individual dialysis treatment machines.

[0003] Dialysate concentrate is one of several precursor substances from which a dialysis machine prepares the finished dialysate. "Dialysis solution" is often used synonymously with dialysate in this context.

[0004] Dialysate concentrate differs from ready-to-use dialysate in several respects. For example, dialysate concentrate has a different ion concentration or density. Generally, dialysate concentrate produced using a central concentrate mixing system is understood to be an acidic concentrate, also called acid concentrate (A). This acid concentrate often consists of water, sodium chloride, magnesium chloride, calcium chloride, potassium chloride, an acid such as acetic acid or citric acid, and a sugar such as glucose.

[0005] Acidic concentrates such as the A concentrate are inherently self-disinfecting, so they do not usually require any special disinfection procedures.

[0006] The basic precursor of the dialysate, also called B-concentrate or bicarbonate, can be added separately to a dialysis machine. This means that the dialysate can be prepared quickly and efficiently within the dialysis machine.

[0007] In contrast, the preparation of dialysate concentrate is a time-consuming process that can take anywhere from several minutes, for example 90 minutes, to several hours. This is because the dissolution processes take considerably longer with small amounts of water, as the quantities of components to be dissolved can approach saturation, meaning that undissolved raw materials may remain for extended periods. From a process perspective, this presents the problem that the usual conductivity measurements used as quality indicators or control measurements in dialysis machines have a high degree of uncertainty due to the large number of charge carriers (dissolved ions), rendering them unsuitable.

[0008] The continuous and uninterrupted availability of the dialysis concentrate is of utmost importance for patient safety, as an interruption in supply can have critical, in the worst case fatal, consequences for a patient during dialysis treatment.

[0009] To ensure this uninterrupted supply, it is standard practice to use redundant storage tanks. If a level sensor detects that the primary storage tank is empty, the system automatically switches to the redundant tank. At the same time, a user, such as a technician, is informed that a new batch of concentrate needs to be produced.

[0010] The (acidic) dialysate concentrate (A concentrate) is typically produced in fixed batches, with the batch size often determined by the mixing system itself—or rather, by the size of its mixing tank. Typical batch sizes are, for example, in the range of 300, 500, and 750 liters. Production generally proceeds by initially adding the corresponding, predetermined amount of water. This ensures that the water quantity is correct, independent of the other raw materials. Subsequently, the other raw materials to be dissolved can be added. Since acidic dialysate concentrates have such high ion concentrations that they are below, but roughly close to, the solubility product, the mixing process itself is essentially a dissolution process.

[0011] The user must then connect a new raw material container to the mixing plant to initiate the production of a new batch, which will be used to refill the emptied tank.

[0012] This reactive approach has several disadvantages. The need to maintain redundant hardware increases infrastructure costs and space requirements in the clinic. Furthermore, the need to produce a new batch often arises unexpectedly, making efficient planning of workflows and staff deployment difficult. In particular, such unforeseen demands can lead to work interruptions or deployments outside of regular working hours. TASK

[0013] The present invention is therefore based on the objective of providing a device that improves the logistical planning of concentrate production and enables higher efficiency and security of supply. BRIEF SUMMARY OF THE INVENTION

[0014] The problem underlying the present invention is solved by a device having the features of claim 1 and a use having the features of claim 8.

[0015] Advantageous embodiments and further developments of the invention are specified in the respective subclaims or are the subject of the description as well as the figures.

[0016] The method or device according to the invention, as well as the use according to the invention or the computer program product according to the invention, enable the availability of dialysis concentrate to be ensured, which guarantees an uninterrupted supply and at the same time optimizes the use of personnel.

[0017] According to a further embodiment of the invention, determining the remaining quantity involves measuring a fill level, a mass, or quantities withdrawn.

[0018] This enables precise and reliable measurement of the concentrate level using common and proven sensor technologies.

[0019] According to a further embodiment of the invention, the method also includes the step of checking the availability of dialysis water.

[0020] This prevents failed mixing attempts due to resource scarcity and increases the reliability of the overall system.

[0021] According to a further embodiment of the invention, the notification signal provides instructions for the production of the new batch of dialysis concentrate.

[0022] This creates a clear and unambiguous instruction for action, which increases process reliability.

[0023] According to a further embodiment of the invention, the method further comprises the step of receiving a start command from a user interface.

[0024] This allows for convenient, semi-automated control of the manufacturing process by the user remotely.

[0025] The device according to the invention for ensuring the availability of a batch of dialysis concentrate comprises a data interface, a data processing unit and a communication unit configured to perform the steps of the method.

[0026] Such a device allows the advantages of the method to be realized in a dedicated and integrable technical unit.

[0027] The use of the device according to the invention to ensure the availability of a batch of dialysis concentrate ensures an uninterrupted supply and highlights the central technical benefit of the invention in the critical clinical application case.

[0028] The computer program product according to the invention enables the flexible implementation of the inventive logic on different, suitable hardware platforms, such as those that may already be available in a clinic. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Further features and advantages of the invention will become apparent from the following description of exemplary embodiments with reference to the accompanying drawings. The components are not necessarily shown to scale in the drawings; the focus is instead on illustrating various embodiments of the invention. The drawings show: Fig. 1 a schematic representation of an embodiment of the system according to the invention, illustrating the interaction between the core components of the device and the clinical environment; Fig. 2 a detailed representation of an embodiment of a device according to the invention with regard to its functional components; and Fig. 3 a schematic flowchart illustrating the logical steps of an exemplary embodiment of the method. DETAILED DESCRIPTION OF THE INVENTION

[0030] The invention will now be described in more detail with reference to the figures. It should be noted that different aspects are described, each of which can be used individually or in combination. That is, each aspect can be used with different embodiments of the invention unless explicitly presented as a pure alternative.

[0031] Furthermore, for the sake of simplicity, reference will generally be made to only one entity at a time. Unless explicitly stated otherwise, the invention may also include several of the entities concerned. Therefore, the use of the words "a," "an," and "a" should only be understood as an indication that at least one entity is used in a simple embodiment.

[0032] Unless explicitly stated otherwise, the individual steps of a procedure described below can be arranged and / or combined in any order. Furthermore, unless expressly indicated otherwise, the procedures can be combined with one another.

[0033] Information with numerical values ​​should generally not be understood as exact values, but also include a tolerance of + / - 1% to + / - 10%.

[0034] References to standards or specifications are to be understood as references to standards or specifications that are valid or were valid at the time of filing and / or – insofar as priority is claimed – at the time of the priority filing. However, this does not imply a general exclusion of applicability to subsequent or superseding standards or specifications.

[0035] The following refers to Fig. 1 An embodiment of the system S according to the invention is described. The Fig. The system S shown in Figure 1 is typically arranged in a clinical setting, such as a dialysis clinic or dialysis center. It can include various components for the production and distribution of dialysis concentrate, as well as a device according to the invention for predictive planning.

[0036] A mixing plant 60 is used to produce batches of the dialysis concentrate. The produced concentrate is stored in at least one storage tank 20. From this storage tank 20, one or more dialysis treatment machines 70 are supplied with the concentrate. The mixing plant 60 can itself be supplied with dialysis water required for the mixing process by a water treatment plant 50 or supplied with dialysis water from another source.

[0037] A device according to the invention comprises a data processing unit 10. This data processing unit 10 generally has at least one data interface 12 and a communication unit 14.

[0038] It goes without saying that the distinction between data interface and communication unit serves only to better illustrate the invention and does not necessarily imply a separation into two physical units.

[0039] Data interface 12 is configured to receive various data.

[0040] This data includes, for example, information about the remaining amount of concentrate in a storage tank 20.

[0041] This information can come, for example, from a level sensor 22, a scale 24 weighing the storage tank 20, or a flow meter 26.

[0042] The designation of a level sensor 22 is exemplary. Different versions exist, providing either continuous information about the fill level or binary information indicating that a specific fill level has been reached or fallen below. Therefore, multiple level sensors 22 can be provided, which, depending on their arrangement on / in the storage tank 20, provide corresponding information about the fill level in discrete steps.

[0043] A scale 24 can have any shape adapted to the storage tank 20 and other conditions. A scale 24 can also provide continuous information about the fill level. It should be noted here that a corresponding scale can also be provided for a mixing plant 60 to weigh raw materials for preparation.

[0044] With the help of a flow meter 26, continuous information about the fill level can also be provided when the full state is known and the flow rate is continuously measured.

[0045] There are no limits to the design, so that, for example, several measuring elements can be used to provide redundancy and / or plausibility checks.

[0046] Optionally, the data interface can access or receive 12 planned process data, for example, from the 70 dialysis treatment machines or a (central) hospital planning system (not shown). This data defines the future consumption of the dialysis concentrate. The data can be any information that allows for the determination of expected demand. This can include the treatment data itself, as well as pure quantity data, i.e., pure process data. For example, an average expected consumption can be inferred from the planned number of treatments and / or the treatment durations.

[0047] Optionally, the data interface 12 can also access a database 40 to retrieve historical consumption data. This database can also be part of a dialysis treatment machine 70 or a (central) hospital planning system (not shown). It is also possible for such a database to be distributed, e.g., across several dialysis treatment machines 70.

[0048] For example, the data processing unit 10 can be configured to not only access planned operation data but also apply statistical methods to historical consumption data. This allows recurring patterns, such as typically higher consumption on certain days of the week, to be identified and included in the calculation of the exhaustion point. This results in a more robust and accurate consumption forecast that can also compensate for unexpected deviations from the planned data. In an alternative embodiment where no planned operation data is available, the consumption forecast can also be based solely on historical data and the statistical methods applied to it.

[0049] Furthermore, the data interface 12 can also receive information about the availability of dialysis water from an exemplary water treatment plant 50.

[0050] The information received in this way can then be further processed by data processing system 10. Data processing system 10 is configured to process the data in order to determine an action instruction.

[0051] The result of this determination, a notification signal, can be transmitted by the communication unit 14, for example, to a user interface 30. The user interface 30 can be, for example, a mobile device such as a smartphone or a stationary clinic PC. There are no technological limitations here. One-way communication—e.g., via a pager—can be used, as well as two-way communication—e.g., for a secure transmission protocol—which also allows for acknowledgment. Two-way communication with acknowledgment is preferred because it allows further alerts to be triggered if no acknowledgment of the order is received within certain timeframes, and / or if no reprocessing is signaled within a certain timeframe.

[0052] Optionally, the user can send a start command to the mixing plant 60 via the user interface 30 to initiate the mixing process.

[0053] In Fig. Figure 2 shows a detailed representation of the functional components of a device according to the invention.

[0054] The device features a data processing unit 10 as its central logical unit. Within the data processing unit 10, a (specialized) computing unit 16 may be provided, configured to perform the computationally intensive steps of the process, in particular determining whether the remaining quantity of the already produced dialysis concentrate and any existing reserve of a similar dialysis concentrate are sufficient.

[0055] Without limiting the generality, the computing unit 16 can be provided in a variety of ways. For example, the computing unit 16 can be provided by a suitable microcontroller / microprocessor / FPGA / ASIC.

[0056] Data interface 12 serves as a logical input and output module for data. Data interface 12 can receive data from external components such as sensors – level sensor 22, scale 24, or flow meter 26 – a database 40, or the water treatment plant 50.

[0057] The communication unit 14 serves to convert the information generated by the data processing unit 10 into a notification signal and to transmit this (in a time-controlled manner) to the user interface 30.

[0058] Fig. Figure 3 illustrates the logical steps of an exemplary implementation of the method in a schematic flowchart.

[0059] The process begins with the receipt of data. The exact order is irrelevant. The data can arrive and / or be queried in different sequences or simultaneously. The only essential requirement is that the data necessary for a calculation is available before the calculation begins.

[0060] For example, one step involves receiving information about the remaining quantity in storage tank 20 (100). Optionally, further data, such as process data, can also be received and taken into account in a subsequent calculation (120).

[0061] It should be taken into account that the information about the remaining quantity can also be calculated (locally), since the volume of the originally prepared material in the storage tank 20 is known and thus a remaining residual volume, i.e. information about the remaining quantity, can also be determined from the consumption, as can be provided (continuously) by a flow meter 26.

[0062] As an optional step, additional historical consumption data can be retrieved from one (or more) database(s) 40.

[0063] Furthermore, it is possible to apply the statistical method to the different data received, both jointly and / or individually, in order to refine or complete the data basis for the subsequent calculation. Statistical methods include not only classical regression analyses but also AI-supported methods.

[0064] Based on this data - i.e. received data and / or processed received data - it can be determined in a determination step 120 whether the remaining quantity of the already produced dialysis concentrate and any existing reserve of a similar dialysis concentrate is sufficient.

[0065] If a storage tank 20 is detected as empty by a level sensor 21, a scale 24, or by the cumulative consumption measured by a flow meter 26, or if a defined lower fill level limit is reached, the device can trigger appropriate actions. The condition for this can be preset or specified specifically for a dialysis concentrate.

[0066] It should be noted that the receiving step 100 and the determining step 120 can also be provided by a level sensor 21 or by scale 24 or by accumulating the consumption using a flow meter 26, whereby the receiving corresponds to the measurement and the determination can be found in comparison with reference values ​​or, for example, in the case of the level sensor 24, also in the triggering / interruption of an electrical circuit / triggering of a switching signal.

[0067] If the determination 120 shows that the quantity is insufficient, a notification signal can be transmitted via a user interface 30 in step 140, indicating that, if available, the reserve of the same type of dialysis concentrate should be connected and / or the production of a new batch of the dialysis concentrate should be initiated.

[0068] The notification signal can be configured accordingly. For example, if a reserve is still available, the system S – if capable – can be instructed to use the reserve batch and mark the previously used storage tank 20 as available for the preparation of a new dialysis concentrate. This can obviously also include further steps, such as emptying any remaining contents and / or cleaning and / or reconstitution, for which the previously used storage tank 20 is now available.

[0069] If, however, no reserve is available, the system S - if capable - can be instructed to initiate a new preparation or any necessary preliminary steps in a mixing plant 60.

[0070] If the system S is not enabled, or in addition to enabling the system S, the notification signal can also be directed to a user to instruct them to take the necessary steps.

[0071] It should be noted that the "empty" detection in step 120 can be designed to take into account processing times and / or remaining planned treatments. Thus, for example, if the empty detection still allows for one more treatment, but no further processing is expected for a certain period, this treatment can be completed, and then the preparation of a new batch can be initiated.

[0072] It should be noted that a notification signal for the user can take any suitable form. In addition to the options already mentioned, a visual or audible notification can also be provided as an alternative or supplement.

[0073] This means the user can be informed that a new mixture is needed to ensure sufficient fluids are available for treatment. The system detects the condition and informs the user that, depending on the type of dialysis concentrate, which has fallen below the defined minimum quantity, a new batch of raw material must be prepared or mixed to ensure that a (redundant) quantity or storage container is available to guarantee uninterrupted treatment.

[0074] To produce the corresponding new batch, the user can be informed which raw material container to connect. This allows the production of the new batch of dialysis concentrate to begin and a (redundant) storage container to be filled again.

[0075] The user can be automatically informed and supported and guided in the selection and necessary steps for connecting the appropriate raw material container (e.g., choosing the correct type required, etc.).

[0076] The invention makes it possible to dispense with the previously required manual regular checks.

[0077] After successful mixing as a (redundant) quantity of dialysis concentrate and transfer to a new storage tank 20, the user can be informed that the previously used raw material container / storage tank 20 can be removed. The mixing system can then perform the self-cleaning process with respect to the previous storage tank 20, or it will be ready again for a new mixture.

[0078] Regular manual checks and monitoring of the system condition or fill level of the dialysis concentrate of the various types and necessary interventions at the mixing system and the storage containers can therefore be eliminated.

[0079] Since no manual control or monitoring is required, work processes are significantly simplified and the workload for staff is reduced. The potential for human error is also minimized, freeing up resources that can be used for other tasks.

[0080] Further boundary conditions can be examined in subsequent, but typically optional, steps.

[0081] For example, in a verification step 130, the availability of sufficient quantities or flow rates of dialysis water from a water treatment plant 50 can be ensured.

[0082] If a sufficient quantity or flow rate of dialysis water from a water treatment plant 50 is not ensured, a warning signal – analogous to the notification signal in step 160 – can be transmitted, as the security of supply is now seriously compromised. The notification signal in step 160 can have a higher priority in order to alert a user accordingly.

[0083] This verification step can also involve a broader view of the process chain, accessing, for example, planning and / or process data from a water treatment plant and / or upstream process units, such as a water pretreatment system. For instance, the amount of water required for filter (back)washing or softener regeneration, as well as planned maintenance or downtime, can be taken into account early on. Similarly, the availability of other raw materials can also be considered. If insufficient quantities of certain raw materials are available, this can trigger reprocessing or reordering, ensuring a timely supply.

[0084] Finally, in transmission step 140, a notification signal is transmitted via user interface 30, indicating that any available reserve of the same dialysis concentrate should be connected and / or that the production of a new batch of the dialysis concentrate should be initiated. The notification signal can have different priorities. For example, if the available time frame for action is short, the priority can be increased.

[0085] The user receives instructions for the production of the new batch of dialysis concentrate by means of a separate notification signal or the notification signal.

[0086] Optionally, in step 150, the procedure can receive a start command from user interface 30 or another user interface to trigger the mixing process in the mixing plant 60.

[0087] Even though the process is depicted as complete in the figures, it is clear that this process can also be designed to be continuous. The process can also be event-driven, for example, after the completion of a dialysis treatment, e.g., by a dialysis machine 70 and / or a hospital server, or time-driven, for example, periodically or at predetermined intervals after the availability of a finished batch of dialysis concentrate. If a re-evaluation results in a change, this change can be communicated to the user in the manner already described, possibly with an explanation of the reason for the re-evaluation. If multiple re-evaluations occur with regard to determining an action window, these can also be communicated to the user, thus making systemic disruptions transparent. Reference symbol list 10 Data processing unit 12 Data interface 14 Communication unit 16 units of calculation 20 storage tank 22 Level sensor 24 scale 26 flow meters 30 User interface 40 database 50 Water treatment plant 60 Mixing plant 70 dialysis treatment machines 100 Received (Information about remaining quantity) 120 Calculate (Determine if quantity is sufficient) 130 Check (availability of dialysis water) 140 Transmit (notification signal) 150 Receive (Start command) 160 Transmit (warning signal)

Claims

[1] Device for ensuring the availability of a batch of dialysis concentrate, comprising • a data interface (12) configured to receive information about the remaining quantity of a previously produced dialysis concentrate in a storage tank (20); • a data processing unit (10) which is connected to and configured with the data interface (12) to determine whether the remaining quantity of the already produced dialysis concentrate and any existing reserve of a similar dialysis concentrate is sufficient, • a communication unit (14) which is connected to and configured with the data processing unit (10) to transmit a notification signal indicating that, if available, the reserve of the same dialysis concentrate should be connected and / or that the production of a new batch of the dialysis concentrate should be initiated. [2] Device according to claim 1, characterized by , that the data interface (12) is connected to a level sensor (22), and / or a scale (24) and / or a flow meter (26) to receive information about the remaining quantity. [3] Device according to claim 1 or 2, characterized by that the data processing unit (10) is integrated into an on-premise computing device, a clinic server or a control system of a mixing plant (60). [4] Device according to any one of claims 1 to 3, characterized by , that the communication unit (14) is configured to transmit the notification signal as a push message to a mobile device or as a display on a stationary display device, which form the user interface (30). [5] Device according to any one of claims 1 to 4, characterized by, that the data processing unit (10) is still configured to check the availability of dialysis water from a water treatment plant (50) before the action time window is determined. [6] Device according to any one of claims 1 to 4, characterized by , that the data processing unit (10) is still configured to provide instructions for the production of the new batch of dialysis concentrate in a separate notification signal or the notification signal. [7] Device according to any one of claims 1 to 6, characterized by , that the data interface (12) is still configured to receive a start command from the user interface (30) to initiate a mixing operation in a mixing plant (60). [8] Use of a device according to any one of claims 1 to 7 to ensure the availability of dialysis concentrate in order to ensure an uninterrupted supply to one or more dialysis treatment machines (70).

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