Method and apparatus for checking functionality of a delivery device for a medical treatment device - Patent Application 20070122997

Abstract

The present invention relates to a method for testing the functionality of a delivery means (F1, F2, F3) of a medical treatment device (100), in which the pressure in a container filled with a liquid is increased by the delivery means. The pressure increase is performed by a predetermined number of delivery movements of the delivery means. A determination about the functionality of the delivery means is made by measuring the pressure in the container and comparing it with a reference pressure value.

Description

[Technical Field]

[0001] The present invention relates to a method according to the preamble of claim 1, to a control device or closed-loop control device according to the preamble of claim 11, and to a medical treatment apparatus according to the preamble of claim 12. Furthermore, the present invention relates to a digital storage medium according to claim 23, to a computer program product according to claim 24, and to a computer program according to claim 25 or the preambles or general terms of each of these claims. [Background technology]

[0002] Various types of medical treatment devices are known. Among the known medical treatment devices are blood treatment devices, particularly devices for hemodialysis, hemofiltration, and hemodiafiltration. During extracorporeal blood treatment, blood flows through an extracorporeal blood circuit and passes through a blood treatment unit. In devices for hemodialysis, hemofiltration, and hemodiafiltration, the blood treatment unit is simply a dialyzer or filter separated into a blood chamber and a dialysate chamber by a semipermeable membrane. During hemodialysis or hemodiafiltration blood treatment, blood flows through the blood chamber and dialysate flows through the dialysate chamber.

[0003] In some blood treatment devices, the dialysate can be prepared by volumetric mixing, which means that at least one liquid is administered by volume or on a volumetric basis. For example, pure water and at least one concentrated liquid may be administered volumetrically and mixed into new dialysate according to a given formulation.

[0004] With volumetric dosing, the precision with which the delivery device being used operates is crucial. An incorrect dose will result in an incorrect dialysate composition. The delivery precision of the delivery device may change over time. This may be caused by leaks, expansion of the material, deposits in the delivery device and / or in the tubing, and wear. While leaks can be easily and reliably detected using automated integrity tests such as pressure hold tests, other causes that may lead to higher or lower flow rates are not easily detectable automatically.

[0005] To avoid endangering patient safety, incorrect doses must be eliminated. For this reason, delivery devices are designed to be robust so that changes in delivery capacity due to operating conditions over their useful life are as small as possible. Nevertheless, the delivery capacity of a delivery device may change over time.

[0006] The conveying capacity can be checked, for example by measurement, if a deviation is suspected. If the conveying capacity is insufficient, the conveying device is to be replaced. Such work is usually carried out by a qualified service technician.

[0007] The more frequently the delivery device of a medical treatment device is checked, the more reliably the treatment device can function. Periodic automatic checks of delivery capacity are necessary. For example, changes in delivery device capacity should be automatically detected as part of periodic automatic functional testing. Summary of the Invention

[0008] The object of the present invention is to propose a method for checking the delivery accuracy of a delivery device of a medical treatment device. Furthermore, a control or closed-loop control device (i.e. a control device that can optionally also be adjusted) is proposed that can perform or start the method. Furthermore, a further device, in particular a medical treatment device (treatment device for short), that is suitable for carrying out the method is also described.

[0009] The object according to the invention is achieved by a method having the features of claim 1. It is also achieved by a control device or closed-loop control device having the features of claim 11, a medical treatment apparatus having the features of claim 12, a digital storage medium having the features of claim 23, a computer program product having the features of claim 24 and a computer program having the features of claim 25.

[0010] According to the invention, a method is proposed for checking the functionality of a delivery device of a medical treatment apparatus for extracorporeal blood treatment.

[0011] The method preferably includes providing a container, preferably completely filled with liquid, wherein air or another gas is preferably not provided within the container, the container being in fluid or conveying communication with a conveying device.

[0012] The method further includes setting a predetermined initial pressure in the container, preferably read from and / or permanently stored in a storage device. Setting may be performed, purely by way of example, using a pump and / or valve in a line fluidly connecting the container to the exterior of the container. For example, the container may first be filled air-free using a filling pump, and an ultrafiltration pump may be used to ensure a predetermined liquid pressure in the container. The initial pressure is preferably provided by a conveying device whose functionality is checked, and preferably not by another, further conveying device whose functionality is also checked. This is sometimes referred to herein as a defined fill, i.e., the pressure after filling is known and / or predetermined. Preferably, there is a difference from atmospheric pressure.

[0013] The method comprises controlling the conveying device to perform a predetermined or specified number of conveying movements. Such conveying movements may be strokes, rotations, impacts, angular steps, steps, etc. of the conveying device or its components depending on the type of conveying device. Control may be understood as triggering or requesting the predetermined conveying movements. These conveying movements preferably start only after a predetermined initial pressure has been set. The predetermined or fixed number of conveying movements preferably starts, starting with the first of these conveying movements, only after the initial pressure has been ensured or reached.

[0014] The method further comprises measuring the pressure generated in the container by pressure measurement after a predetermined number of conveying movements of the conveying device are completed, followed by defining or designating the measured or determined pressure as a final pressure that may be assigned to the conveying device under consideration.

[0015] The method further includes reading the stored reference value from the first storage device. The reference value may be a reference pressure or a reference pressure difference. The reference value may be, in particular, + / - 5 hPa to + / - 500 hPa compared to atmospheric pressure. The first storage device may be provided as part of the medical treatment device, for example as an internal memory thereof, or may be provided separately therefrom.

[0016] The method further includes determining a pressure difference between the measured final pressure and the stored reference value. Alternatively, a pressure difference between the difference between the initial pressure and the final pressure on the one hand and the stored reference value on the other hand is determined.

[0017] The method also includes evaluating the determined pressure differential, for example, based on predetermined criteria.

[0018] The result or purpose of the evaluation may be to determine an unacceptable pressure difference between a reference value assigned to the delivery device and the measured final pressure or determined pressure difference.

[0019] If it can be assumed with sufficient accuracy that the level of pressure that will be created in the container after filling as described above is already known, e.g., due to the filling process itself, then the pressure measurement at the start of the method may be omitted. In some embodiments, it may also be possible to measure the created pressure at least once before the conveying movement is carried out, e.g., for control purposes.

[0020] Optionally, the steps described above may be performed in the order given above.

[0021] According to the invention, a control device or closed-loop control device (also called control device for short in this document) is proposed, which is arranged to cooperate with a medical treatment device to initiate or carry out the method according to the invention.

[0022] The present invention also proposes a medical treatment device (abbreviated as treatment device). The treatment device according to the invention comprises or is connected to a liquid system, in particular a dialysis fluid system, having a container for a liquid, a pressure measuring device (preferably an absolute pressure measuring device) for measuring the pressure occurring in the container, and a first storage device in which a reference value is stored. The reference value in this context is in particular a reference pressure or a reference pressure difference.

[0023] The treatment apparatus according to the present invention further comprises or is connected to a read-out device, which is configured to read out the stored reference value assigned to the carrying device from the first storage device.

[0024] Furthermore, the treatment device according to the invention comprises or is connected to a determination device configured to determine the pressure difference between the measured final pressure and a stored reference value or to determine the pressure difference between the difference between the initial pressure and the final pressure on the one hand and the stored pressure difference as the stored reference value on the other hand.

[0025] An evaluation device configured to evaluate the determined pressure difference is also included in the treatment apparatus according to the invention or is connected to it in signal communication, whereby the evaluation of the determined pressure difference may be performed, for example, on the basis of predetermined criteria.

[0026] The treatment apparatus comprises or is connected to at least one delivery device in fluid or delivery communication with the container, and in particular with its contents or lumen.

[0027] A control device or closed-loop control device, in particular a control device or closed-loop control device according to the invention, is also included in or connected to the medical treatment apparatus according to the invention, and is configured to direct, implement, control and / or regulate, in particular automatically, the methods according to the invention disclosed herein by interacting with further devices or apparatuses of the medical treatment apparatus.

[0028] Interaction may be or involve actuation, control, or regulation. Interaction may be or require signaling.

[0029] The medical treatment apparatus according to the present invention may comprise or be connected to correspondingly suitable and / or configured devices or apparatuses for each of the steps of the method according to the present invention described herein, such as, for example, an evaluation unit for evaluation, a pressure measuring device for pressure measurement, a filling device (e.g., a pump or a valve) for filling the container, etc.

[0030] A digital, in particular non-volatile, storage medium (herein also referred to as carrier) according to the invention, in particular in the form of a floppy disk RAM, ROM, CD, hard disk, DVD, USB stick, flash card, SD card or EPROM, carrying in particular electronically or optically readable control signals, may be adapted to configure a control device into a control device capable of performing the inventive methods described herein. Alternatively or additionally, the digital storage medium may be adapted to configure a medical treatment apparatus into a medical treatment apparatus according to the invention, capable of performing or implementing the inventive methods described herein.

[0031] Here, all, some, or a portion of the machine-guided steps of the method may be prompted.

[0032] A computer program product according to the present invention comprises program code stored on a volatile or machine-readable carrier, whereby a control device is configured to perform the inventive methods described herein. Alternatively or additionally, the computer program product may be used to configure a medical treatment device such that the inventive methods described herein can be performed or implemented.

[0033] Again, all, some, or a portion of the machine-guided steps of the method may be prompted.

[0034] The term "machine-readable carrier" as used herein refers, in certain embodiments of the invention, to a carrier containing data or information that can be interpreted by software and / or hardware. The carrier may be a data carrier such as a diskette, CD, DVD, USB stick, flash card, SD card, EPROM, or the like.

[0035] The computer program according to the present invention comprises program code by which a control device or a closed-loop control device or a medical treatment apparatus can be configured to perform or implement the method according to the present invention as described herein.

[0036] Here, all, some, or a portion of the machine-guided steps of the method may be prompted.

[0037] A computer program product may according to the invention be understood as, for example, a computer program stored on a carrier, an embedded system as a comprehensive system comprising a computer program (e.g. an electronic device comprising a computer program), a network of computer-implemented computer programs (e.g. a client-server system, a cloud computing system, etc.), or a computer on which a computer program is loaded, run, stored, executed or developed.

[0038] According to the present invention, a computer program can be understood as a physical marketable software product comprising the program.

[0039] In all of the above and below, the use of expressions such as "may be" or "may have" should be understood as synonymous with "preferably is" or "preferably has", respectively, and is intended to exemplify embodiments according to the present invention.

[0040] Whenever numerical terms are described herein, those skilled in the art shall recognize or understand them as indicating a lower numerical limit. Unless this leads the skilled artisan to an obvious contradiction, those skilled in the art shall understand, for example, that a designation of "one" encompasses "at least one." This understanding is also equally encompassed by the present invention, as is the interpretation that a numerical term, for example, "one," may alternatively mean "exactly one," whenever this is clearly technically possible for those skilled in the art. Both understandings are encompassed by the present invention and apply to all numerical terms used herein.

[0041] Whenever "programmed" or "configured" are mentioned herein, it is disclosed that these terms are interchangeable.

[0042] Each advantageous development of the invention is also the subject of an embodiment and dependent claims.

[0043] Whenever an embodiment is described herein, it is an exemplary embodiment according to the present invention.

[0044] When the subject matter of the present invention is disclosed herein as comprising one or several features in a particular embodiment, it is also hereby disclosed, e.g., by way of a disclaimer, that the subject matter of the present invention does not explicitly comprise one or several of those features in other embodiments of the present invention. Therefore, for every embodiment described herein, it also applies that the opposite embodiment, e.g., formulated as a negation, is also disclosed.

[0045] Embodiments according to the invention may comprise one or more of the above and / or below features in any technically possible combination.

[0046] The initial pressure is preferably the pressure at which the delivery device whose functionality is being checked begins delivery.

[0047] The reference values ​​may be stored or have been stored in a first storage device, which may be part of the transport device or part of the medical procedure apparatus in which the transport device is configured, for example by a manufacturer during manufacture, or by a technician during commissioning and / or prior to operation of the transport device to be checked, for checking the transport device or for carrying out the method of the present invention. The invariant reference values ​​may be read therefrom when the method of the present invention is carried out.

[0048] The reference value is preferably not an initial pressure and / or not a pressure generated by another conveying device to check the functionality of this device.

[0049] If the transport device is later replaced, for example for maintenance or repair, the reference value may be determined anew, as was already done at the time of manufacture or commissioning, and stored in a suitable location, such as a first storage device, preferably power failure tolerant, which may also be part of the method according to the invention.

[0050] To avoid data loss (eg, when replacing individual computer boards), copies of the stored reference values ​​may be distributed among several computer boards.

[0051] The reference value may be stored, for example, in a non-volatile random access memory (NOVRAM), which is a memory module that can be primarily written to periodically but whose last valid data content is still saved in an internal ROM area in the event of an external power failure. A capacitor integrated in the NOVRAM provides the energy necessary to copy the contents of the RAM area, also integrated in the NOVRAM, into the ROM area in the event of a failure of the externally applied voltage.

[0052] In some embodiments, the method according to the invention further comprises the step of setting a predetermined temperature (predetermined temperature value) in the container in order to achieve predetermined or fixed, and therefore comparable, states or the same general conditions for carrying out the check, in particular the pressure measurement.

[0053] In other embodiments, the temperature occurring in the container while the method is being performed is measured without necessarily being set to a predetermined temperature. In these embodiments, the measured temperature may optionally be taken into account, for example, by applying a correction factor to the measured pressure or by converting the measured pressure value depending on the measured temperature. The reference values ​​may be stored in table form and may be retrieved, for example, depending on the temperature occurring during the check of the transport device.

[0054] In some embodiments of the method, the evaluating step comprises or consists of determining whether the determined pressure differential or amount is within predetermined limits, above or below a limit, above a minimum value, and / or below a maximum value, thereby providing a criteria-based evaluation (such as a limit, range, maximum value, etc.).

[0055] In some embodiments, the method includes the further step of outputting an acoustic and / or optical alarm. In particular, this alarm is output if the evaluation produces results that have been previously defined as unacceptable. These results that have been previously defined as unacceptable may be stored, for example, in a storage device. The storage device may correspond to the first storage device or may be a separate storage device.

[0056] Alternatively or additionally, the alarm is generated when a predetermined limit is violated, in particular when a lower limit value is dropped or an upper limit value is exceeded, when a range of acceptable values ​​is exceeded, or when a predetermined amount of pressure difference is exceeded.

[0057] In some embodiments, the method includes the further step of storing the final pressure or the determined pressure differential in a second storage device, which may be, for example, an internal storage device of the medical treatment apparatus, which may be the same as or different from the first storage device.

[0058] In some embodiments, the method comprises the further step of determining a wear curve from the stored values, for example by calculation.

[0059] Such a curve may be evaluated, for example, based on its slope or other characteristics to enable early developments or trends to be identified.

[0060] In some embodiments, the container comprises or consists of a section of the spent water branch of the balancing system.

[0061] In some embodiments, the container is or comprises a section within a fluid line of a dialysate system of a medical treatment device.

[0062] In some embodiments, the delivery device is an ultrafiltration pump, a bicarbonate pump, or a sodium pump.

[0063] In some embodiments, the at least one conveying device is a positive displacement pump, in particular a diaphragm pump, an eccentric diaphragm pump, a tube pump, a roller pump, or a piston pump.

[0064] In some embodiments, at least one delivery means is a flow pump. When using a flow pump, conveyance is achieved solely by a fluid dynamic process. This means that there is a permanent connection between the suction side and the pressure side of the pump, i.e., the medium flows freely through the machine, i.e., without flaps or valves. In a stopped state, the medium can flow backward through the pump, i.e., against the pumping direction. This type includes gear pumps, impeller compressors, centrifugal pumps, etc. In these embodiments, precise volumetric conveyance is not possible without additional force, for example, from the flow pump and a balancing chamber. Since a defined volume is not drawn using this type of pump, in some embodiments in which this type of pump is used, a defined conveyance rate (e.g., speed or rate per unit time) is preferably set, by which the liquid is pushed into or sucked out of the system or container. Wear can be recognized based on the overpressure or underpressure achieved individually by the conveying device.

[0065] In some embodiments, the medical treatment apparatus includes a heating device configured to heat the liquid present in the container to a predetermined temperature in order to achieve a predetermined or specified condition or general requirement while the pressure measurement is being taken. An appropriate sensor for the feedback loop may be provided.

[0066] In some embodiments, the treatment apparatus further comprises a device configured to determine whether the determined pressure differential is within predetermined limits, above or below a limit value, above a minimum value, and / or below a maximum value.

[0067] In some embodiments, the treatment apparatus comprises a device for outputting an alarm, which may be configured to output an acoustic and / or optical alarm if the evaluation produces unacceptable results, in particular when a predetermined limit is exceeded, when a lower limit or an upper limit is exceeded, when a range of acceptable values ​​is exceeded, or when a predetermined amount is exceeded.

[0068] In some embodiments, the treatment apparatus includes a second storage device configured to store the final pressure or the determined pressure differential in a second storage device, which may be, for example, an internal storage device of the medical treatment apparatus and may be the same as or different from the first storage device.

[0069] The second storage device may be part of the medical treatment device, for example in a section that is read periodically during maintenance activities, but may also be located remotely from the medical treatment device, for example in a location assigned to maintaining or monitoring the treatment device.

[0070] In some embodiments of the medical treatment apparatus, it comprises a device configured to determine, eg calculate, the wear curve from stored values.

[0071] The medical treatment device according to the present invention may be suitable for and / or configured to perform blood treatments, in particular hemodialysis, hemofiltration, hemodiafiltration or separation methods, without being limited thereto.

[0072] In some embodiments, an alarm or message may be issued if a progressive or increasing deterioration in the conveying accuracy of the conveying device is detected at different times over multiple (at least two) sequences of the method of the present invention.

[0073] For example, the medical treatment device may issue a warning or indication of impending maintenance, repair, or replacement of the delivery device due to insufficient delivery accuracy. In this way, replacement can be performed in a timely manner, i.e., before a complete failure actually occurs, which can also help reduce downtime of the treatment device. Maintenance or repair of a delivery device that is identified as inadequate can be scheduled early and therefore not performed at the wrong time, i.e., at a potentially inappropriate time, as opposed to maintenance performed reactively.

[0074] If the method according to the invention is carried out, as contemplated in some embodiments, for example, before each treatment session in which the treatment device is used, or at any short interval, it is possible to identify relatively early the point in time when maintenance or repair of an inadequate delivery device would be best addressed. The point in time at which a treatment device's operation would be impaired due to an inadequate delivery device may advantageously be largely predictable by the method according to the invention using appropriate evaluation of the measured values ​​or obtained results.

[0075] In some embodiments, the results of the methods of the present invention (e.g., as assessment results, deviations from actual transport activity, etc.) are shown or printed out, for example, on the processing device (display) or on an external monitor or display, etc.

[0076] In some embodiments, the results of the method according to the invention, or at least the results recognized as relevant, are stored in a data storage device in a retrievable manner after the method is executed on the treatment device and / or further processed. This data storage may be part of the medical treatment device or may be provided separately therefrom. The results may be further processed to generate a wear curve over time for the delivery device. This curve may be retrieved, if necessary, by, for example, a service technician. Alternatively, the data storage may be available on an external device. Thus, the results may be provided to a network and stored there. If necessary, the results may be retrieved from several devices.

[0077] In some embodiments, the probability of occurrence of a fault or failure due to malfunction of the or each carrying device is determined according to known methods and communicated, for example, by storing in a readable data memory, by display, alarm, etc. Additionally or alternatively, points in time or time periods when such a fault is likely to occur may be determined and communicated.

[0078] In some embodiments, known methods of trend analysis are used to determine, among other things, the probability of occurrence, or the time or duration of, a failure due to a malfunction of the transport device.

[0079] The hardware or software necessary to carry out the above-mentioned determination of probabilities, time points / durations, and / or display and / or transmission of results based thereon is optionally provided, set up, configured, and / or programmed accordingly.

[0080] By using trend analysis, trends, ie medium-term or long-term developments, may be determined and optionally quantified.

[0081] Well-known methods of trend analysis include simple averaging, moving average determination, least squares deviation determination, first order exponential smoothing, and the like.

[0082] In some embodiments, the container comprises at least one conduit section. Alternatively, the container comprises multiple conduit sections in fluid communication with one another and preferably part of the treatment device, particularly its dialysate system. Such conduit sections may be in fluid communication with one another such that fluid pressures induced therein can be set or adjusted unimpeded within the conduit combination.

[0083] In some embodiments, the container is a vessel, and what is described herein for a container applies equally to the design as a vessel in these embodiments.

[0084] In some embodiments, the liquid is a dialysis solution. In some preferred embodiments, the liquid is degassed, pure water without additives (RO water, reverse osmosis water).

[0085] Based solely on an evaluation of the measured values ​​of the pressure measurements, in some embodiments it can be determined whether the delivery device will deliver imprecisely and by how much deviation. Additionally, in other embodiments it may be determined whether the delivery device will deliver imprecisely (or in the worst case, not deliver at all) in the foreseeable future, in which case timely replacement of the delivery device can be advantageously initiated.

[0086] The method according to the invention described herein can be implemented using a medical treatment apparatus according to the invention, the treatment device being configured to implement it using its control device, so that in order to avoid repetition, reference is made to the above description of the method and its implementation.

[0087] In some embodiments, none of the three conveying devices are conveyed into the container during or as a step of the method of the present invention.

[0088] In some embodiments, none of the three delivery devices delivers liquid into the container unless they serve to completely fill the container with liquid.

[0089] In some embodiments, none of the three conveying devices will convey into the container unless they serve to set a predetermined initial pressure before the conveying device is activated to perform the desired conveying activity required to convey a predetermined amount of liquid.

[0090] In some embodiments, the conveying device always starts conveying from the same initial pressure within the method of the present invention, and in these embodiments, no increase in pressure within the container is caused by the conveying device.

[0091] In some embodiments, the container is always the same when the transport device is checked, and the initial pressure developed therein may always be the same, but this is not necessarily the case.

[0092] In some embodiments, the absolute value of a single pressure or the difference between pressures is considered.

[0093] When measuring pressure is referred to herein, this term may in some embodiments also include determining the pressure, for example by calculating the pressure from available values.

[0094] In some embodiments, the volume is not measured, compared, and / or assessed.

[0095] In some embodiments, the functionality of exactly one delivery device is tested up to and including the step of evaluating the determined pressure differential.

[0096] In some embodiments, up to and including the step of evaluating the determined pressure difference, exactly one transport device is used, or exactly one transport device, in particular one transport device that is checked, transports.

[0097] When signal communication or a communication connection between two components is referred to herein, this may be understood to mean the connection that exists during use. It may also be understood that provisions for such signal communication (whether wired, wireless, or otherwise implemented) exist, for example, by coupling both components, for example, by pairing, etc.

[0098] Pairing is a process performed in connection with a computer network to establish an initial link between computer units for the purpose of communication. The best-known example of this is the establishment of a Bluetooth® connection, by which various devices (e.g., smartphones, headphones) connect to each other. Pairing is sometimes also called bonding.

[0099] In some embodiments, the method does not involve calculating the initial amount of liquid and / or air present in the container.

[0100] In some embodiments, the container is not or does not include a mixing chamber.

[0101] In some embodiments, the treatment device comprises rollers for movement, hi some embodiments, the treatment device comprises a touch screen for use by medical staff.

[0102] Some embodiments of the present invention may achieve one or more of the advantages described herein, including the following:

[0103] By using the method according to the invention, it is possible to make reliable statements about the functional efficiency of the delivery device, in particular about the delivery accuracy, preferably by comparing the measured pressure values ​​or pressure differences with stored reference values.

[0104] A further advantage of the present invention is that it enables a medical treatment device to automatically perform checks for sufficient accuracy of its delivery device's delivery activity, eliminating the need to assign a qualified service technician or user for this purpose or limiting it to occasional checks, which can also contribute to cost savings.

[0105] Furthermore, deviations in the transport activity of the transport device that only occur between visits by a qualified service technician or checks by the user can be detected at an early stage, for example as part of daily routine checks.

[0106] Another advantage is the increased ease of use of the general-purpose blood treatment apparatus. With the present invention, the burden of checking and correcting the carrying capacity of the carrying device is not placed on the user. Downtime of the blood treatment apparatus while a qualified service technician works for checking purposes, for example by measuring or using a measuring cylinder, is not required or is less necessary.

[0107] Since the procedure according to the invention is based on a defined filling (pressure and possibly also temperature) of the container which in fact has to be filled anyway for purposes other than testing the conveying device, some of the operations necessary for carrying out the method can be advantageously omitted, i.e. at least the initial filling would already have taken place in any case in many practical applications.

[0108] The method according to the invention makes it possible to check the pump's delivery volume without significant additional effort. By storing the determined pressure values ​​and pressure differences and creating a wear curve, a prediction can be made about possible failures in the near future. In this way, a service technician can check the expected remaining service life of the pump during the next safety inspection and, if necessary, replace the pump early. This advantageously contributes to reducing service calls and thus saving costs.

[0109] The present invention can also be used to determine any damage that may have occurred, such as membrane delamination, tearing, or damage due to wear, which may affect the pumping operation, which is particularly relevant when using eccentric membrane pumps. Thus, the number of elaborate / complex wear tests of the pump by service technicians can be advantageously reduced or completely eliminated.

[0110] Therefore, the more accurately the delivery device of the treatment device is delivered, the safer it can act on the patient, and the earlier the need to replace the delivery device is recognized, the more reliable the medical treatment device can be.

[0111] Furthermore, the statistical evaluation of the failure figures associated with the transport devices can be advantageously improved by the method according to the invention, which advantageously helps to determine actual errors and reduce or completely eliminate the number of undetected non-functional transport devices.

[0112] Finally, it may be advantageous to be able to check a transport device with the present invention even if the medical treatment device does not have a mixing chamber that can be used to check the transport device, particularly a mixing chamber with its own monitoring sensor technology, as may be the case in some embodiments.

[0113] The present invention will be described below on the basis of preferred embodiments thereof with reference to the accompanying drawings. The method according to the present invention and the blood treatment device according to the present invention will be described using the example of a hemodialysis device. However, the method according to the present invention can be used in other blood treatment devices as well, for example in hemodiafiltration devices. [Brief explanation of the drawings]

[0114] [Figure 1] 1 shows a partial piping diagram of a liquid system of a medical treatment apparatus according to a first embodiment of the present invention. [Figure 1a]Section A of FIG. 1 is shown limited to the container shown in FIG. [Figure 1b] 2 shows an alternative container suitable for checking an alternative transport device to that of FIG. 1; [Figure 2] 1 shows a simplified schematic representation of the steps of the method according to the invention, based on the device used for this purpose. [Figure 3] 1 shows a schematic simplified representation of an eccentric membrane pump as an exemplary embodiment of a delivery device. [Figure 4] An exemplary process of the method according to the invention is illustrated by a pressure / transport dynamics diagram. DETAILED DESCRIPTION OF THE INVENTION

[0115] FIG. 1 shows a partial piping diagram of a dialysis fluid system 10 (also called a hydraulic system) as an example of a fluid system of a medical treatment device 100 according to the present invention in a first embodiment, here simply an optional blood treatment device.

[0116] The dialysate system 10 includes a number of pumps, valves, actuators, sensors, and other components, all of which may be independently connected in signal communication with, and optionally controlled and / or read by, a control device or closed-loop control device 29 of the medical treatment apparatus 100.

[0117] The aforementioned pumps include, inter alia, a first transport device F1, here a bicarbonate pump, a second transport device F2, here a sodium pump, and an ultrafiltration pump, here designated as transport device F3.

[0118] These pumps are integrated into the dialysate system 10 in fluid communication with one another. The transport device F3 is fluidly connected to the ventilation device, the temperature sensor TS, and the pressure sensor DS via the conduits shown in FIG. 1a and indicated by bold lines. The conduits connecting them are fluidly isolated from the outside by the (disabled) transport device F3 on the one hand and by the (closed) valves V03, V05, V11, V13, V15, V17, and V25 on the other hand. The volume limited by the above-mentioned transport device F3 and the valves V11, V13, V15, V17, and V25 thus results in a closed vessel or a composite of closed but communicating conduits, in particular a conduit section, or vessel, which is referred to herein as a container. In the context of the present invention, other terms are also conceivable instead of "container," such as a volume, a liquid receiving section, etc.

[0119] The container shown in FIG. 1a, with elements not participating in forming the enclosed volume omitted from FIG. 1, is referred to herein as container 71 (see FIG. 1a).

[0120] The conveying device F3 is positioned relative to the container 71 so as to be able to convey the liquid present in the container 71 from the container 71, which is also done in the course of the method according to the invention in the exemplary embodiment described below.

[0121] For example, the pressure measurement may be performed by a pressure gauge DS located within the container, which may optionally have the highest measurement accuracy of all pressure gauges measuring in the container, such as any other pressure sensors used. The pressure gauge utilized may be an analog-to-digital converter (ADC).

[0122] The control device or closed-loop control device 29 may cooperate with the temperature sensor TS and the heating device H1 to regulate the internal temperature of the container 71 to a predetermined temperature, which may correspond to the temperature at which the reference value P_R (see FIG. 4) was determined during manufacture of the conveying device and may have a value in degrees Celsius (°C).

[0123] The medical treatment device may include other valves, such as V03, V05, V07, or V9. Container 71 may be expanded and / or repositioned by these valves, if necessary, for example, to check conveying devices F1, F2 different from conveying device F3 in the above example. By expanding, it is understood that container 71 may contain more conduit sections of treatment system 100 than in the above example. By repositioning, it is understood that container 71 may contain conduit sections of treatment system 100 other than those in the above example, as shown in FIG. 1b.

[0124] Figure 1a shows the container from Figure 1. Components of Figure 1 that are not involved in forming the closed container 71 are not shown in Figure 1a for a better overview.

[0125] To fill it, the container 71 is in some embodiments filled via a hydraulic line using a liquid source 73 (see FIG. 1 a). The liquid source 73 may be or comprise a source of water, in particular a water tap or a water line, optionally with subsequent devices for cleaning or degassing. In other embodiments, refilling may optionally take place from an external sealed or closed source, for example a liquid bag. The method according to the invention may include filling or may only start when a filled container 71 is present.

[0126] The filling defines an initial pressure P_0 in the container 71, which may alternatively or additionally be controlled or set, for example via valve V13, by using a liquid source 73, especially if the filling is performed by a pump in an undefined manner, whereby the other valves defining the container 71 are optionally closed.

[0127] Optionally, for this purpose, each valve connected to the container 71 may be opened and closed again for filling, the other valves of the container 71 being preferably closed.

[0128] Figures 1 and 1a focus primarily on carrying device F3. This is merely an example; what is said here about F3 can equally apply to F1 and / or F2 (see Figure 1b).

[0129] FIG. 1b shows in the ductwork diagram of the dialysate system 10 from FIG. 1 an alternative container 71' suitable for checking the transport devices F1, F2.

[0130] For this purpose, valves VB2, VS2 and V09 are closed. If necessary, valves VB1 and VS1 give or allow access to pressure sensor DS1.

[0131] What has been said above with respect to container 71 still applies equally to container 71'.

[0132] The liquid for filling the container 71' may originate from a liquid source 73 shown at the top left.

[0133] FIG. 2 shows in a simplified schematic diagram the steps of the method according to the invention based on the device used for this purpose.

[0134] 2, a highly simplified schematic diagram of an exemplary medical treatment apparatus 100 having a dialysate system 10 is shown. A control device or closed-loop control device 29 may be configured to cooperate with a temperature sensor TS and a heating device H1 to provide a predetermined internal temperature of the containers 71, 71′. By activating valves (not shown in FIG. 2) or conveying devices F1, F2, F3 by the control device or closed-loop control device 29, a predetermined initial pressure P_0 inside the containers 71, 71′ may be set, which may possibly be controlled by a pressure sensor DS.

[0135] To check this, the conveying device F3, here an ultrafiltration pump, is guided by the control device or closed-loop control device 29 to perform a predetermined number of conveying movements FB (see FIG. 4). Depending on the embodiment of the conveying device, these may be strokes, rotations, or impacts or beats, for example 5 strokes.

[0136] After a predetermined number of conveying movements FB have been completed, the pressure in the container 71, 71′ is measured by the pressure gauge DS, which may be transmitted to and stored in a second storage device 33, optionally available in particular by the control device or closed-loop control device 29.

[0137] The reference value P_R corresponds to the transport device F3, is stored in the first storage device 31, may be a reference pressure or a reference pressure difference, and is read by the readout device 35.

[0138] The determination device 37 may be configured to determine a pressure difference ΔP between the measured final pressure P_1 and a stored reference pressure P_R. Alternatively, the pressure difference ΔP may be determined between the difference between the initial pressure P_0 and the final pressure P_1 on the one hand and the stored reference value P_R on the other hand, which in this case is the reference pressure difference.

[0139] The evaluation device 39 may be configured to evaluate the determined pressure difference ΔP. The evaluation result may be able to be transmitted to the medical treatment apparatus 100, in particular to its control device or closed-loop control device 29.

[0140] The medical treatment apparatus 100 or the control device or closed-loop control device 29 may be arranged to activate an optional alarm device (not shown in FIG. 2), in particular if the determined amount of pressure difference ΔP is, for example, outside predetermined limits or otherwise fails to meet predetermined criteria.

[0141] FIG. 3 shows, in a schematic and simplified manner, an eccentric diaphragm pump as an exemplary embodiment of a conveying device F1, F2 or F3.

[0142] An elastic membrane 4 is moved up and down by an eccentric 5 and a connecting rod 6 .

[0143] On the downstroke, the membrane 4 sucks in the fluid to be delivered through the inlet valve 2. On the upstroke, the membrane 4 pushes the fluid out of the pump head through the outlet valve 1. Each downstroke, upstroke, or combination of exactly one downstroke and exactly one subsequent upstroke may correspond to a delivery movement FB.

[0144] The transfer chamber 3 is separated gas-tight from the pump drive 7 by a membrane 4 .

[0145] According to the invention, the pressure occurring in the delivery chamber 3 is a negative pressure (underpressure), which advantageously allows a rupture of the membrane 4 of the delivery device to be recognized, since an underpressure prevents the membrane 4 from resting on the plunger. If an overpressure occurs in the delivery chamber 3, it will always press the membrane 4 against the plunger, and in such a case the rupture may remain undetected.

[0146] FIG. 4 shows an exemplary course of the method according to the invention in the form of a diagram of pressure [P] against the number of conveying movements [FB], with reference to the arrangements of FIGS. 1 and 1a.

[0147] In Figure 4, the following applies: P_0 is a predetermined initial pressure, an absolute pressure. P_0 may be measured by pressure measurement using an absolute pressure gauge, or may be calculated or known from or based on other conditions. P_1 is the pressure that develops in the container 71 after the conveying movement of the conveying device is completed, and is referred to herein as the final pressure. P_R is a negative reference value for the pressure (underpressure) in the container 71, i.e., the negative pressure value at which the final pressure is measured after a predetermined number of conveying movements FB of the conveying device, or the pressure difference between the pressure before the conveying movement on the one hand and the pressure after the conveying movement on the other hand. The reference value is advantageously determined in the factory under at least one defined state of the container or under at least one defined general condition. The general condition may be, for example, the internal temperature of the container 71, whereby a narrow temperature range that is acceptable may be defined.

[0148] The method begins after an initial pressure P_0 in the container 71 has been set, optionally at a defined or predetermined internal temperature or within a predetermined narrow temperature range (see FIG. 1), which may be set by the liquid source 73 and at least one conveying device of the medical treatment apparatus 100 and, if necessary, checked by a pressure gauge DS or a temperature gauge TS, respectively.

[0149] The conveying device F3 conveys the liquid from the container 71 in, here illustratively, 10 strokes, and therefore, after the conveying by the conveying device F3 is completed, i.e., after 10 strokes, the pressure gauge DS or another pressure sensor detects that the pressure generated in the container 71 drops to the final pressure P_1.

[0150] In the illustrated example, there is a pressure difference ΔP between the final pressure P_1 and a previously stored reference value P_R, which in this example represents a (pre)determined (by the factory) pressure after, for example, 10 strokes.

[0151] The determined final pressure P_1 is clearly above a more negative reference value P_R, which here is illustratively an underpressure, but which may be an overpressure in other embodiments. If the amount of pressure difference ΔP exceeds a certain value, falls outside a range of acceptable values, or violates another criterion, an alarm may be provided. Such an alarm may be generated acoustically or optically, or in some embodiments may already include an indication that the conveying device F3 is at least limited in terms of its functionality.

[0152] If no alarm is issued, the achieved final pressure P_1 or the determined pressure difference ΔP is stored in the second storage device 33 (see FIG. 2).

[0153] A wear curve may be calculated from several final pressures P_1 or pressure differences ΔP over time and stored if desired. The wear curve may be stored so that it can be read or displayed by a service technician at any time. The inventions described in the claims of the original application are set forth below. [1] A method for checking the functionality of a delivery device of a medical treatment apparatus for extracorporeal blood treatment, comprising: - providing a container filled with a liquid, said container being in fluid or conveying communication with said conveying device; - setting a predetermined initial pressure in the container; - controlling said conveying device to perform a predetermined number of conveying movements; - measuring the pressure generated in the container after completion of the predetermined number of conveying movements of the conveying device using pressure measurement and defining the measured pressure as a final pressure; - reading a stored reference value, which is a reference pressure or a reference pressure difference, from a first storage device; - determining the pressure difference between the measured final pressure and the stored reference value, or determining the pressure difference between the difference between the initial pressure and the final pressure on the one hand and the stored reference value on the other hand; - evaluating said determined pressure differential; A method comprising: [2] - further comprising the step of setting a predetermined temperature within the container with the purpose of reaching or achieving a predetermined condition while measuring the pressure; [1] The method described in [1]. [3] the evaluating step: - determining whether said determined pressure differential is within predetermined limits, above or below a limit value, above a minimum value and / or below a maximum value, The method according to [1] or [2]. [4] - comprising the further step of outputting an acoustic and / or optical alarm if the evaluating step results in a result previously defined as unacceptable, in particular if a predetermined limit is violated, in particular if the pressure difference falls below the lower limit or exceeds the upper limit, if it exceeds a range of acceptable values, if it exceeds a predetermined amount. The method according to any one of [1] to [3]. [5] - including the further step of storing the final pressure or the determined pressure differential in a second storage device, The method according to any one of [1] to [4]. [6] - comprising the further step of determining, e.g. calculating, a wear curve from said stored values; [5] The method described in [5]. [7] The method of any one of [1] to [6], wherein the container comprises or consists of a section of a spent water branch of a balancing system. [8] The method according to any one of [1] to [7], wherein the container is or comprises a section within a liquid line of a dialysis fluid system. [9] The method according to any one of [1] to [8], wherein the transport device is an ultrafiltration pump, a bicarbonate pump, or a sodium pump.

[10] The method according to any one of [1] to [9], wherein at least one conveying device is a positive displacement pump, in particular a membrane pump, an eccentric membrane pump, a tube pump, a roller pump or a piston pump.

[11] A control device or closed-loop control device configured to interact with a medical treatment device to initiate or implement the method of any one of [1] to

[10] .

[12] A medical treatment device, comprising at least: a fluid system, in particular a dialysis fluid system, having a container for the fluid; - a pressure measuring device for measuring the pressure generated in the container; - a first storage device in which a reference value, which is a reference pressure or a reference pressure difference, is stored; - a read-out device configured to read out said stored reference values; a determination device for determining the pressure difference between the measured final pressure and the stored reference value, or for determining the pressure difference between the difference between the initial pressure and the final pressure on the one hand and the stored reference value on the other hand; - an evaluation device configured to evaluate said determined pressure difference; - at least one conveying device in fluid or conveying communication with said container; - a control device or a closed-loop control device, in particular as described in

[11] , configured to initiate the execution of the method according to any one of [1] to

[10] ; 1. A medical treatment device comprising or connected to:

[13] A medical treatment device as described in

[12] , comprising a heating device configured to heat the liquid that is filled or will be filled in the container to a predetermined temperature in order to achieve a predetermined condition within the container during the pressure measurement being performed.

[14] The medical treatment apparatus of

[12] or

[13] , comprising a device configured to determine whether the determined pressure differential is within predetermined limits, exceeds or falls below a limit value, exceeds a minimum value, and / or does not exceed a maximum value.

[15] A medical treatment device according to any one of

[12] to

[14] , comprising a device for outputting an alarm, the device being configured to output an acoustic alarm and / or an optical alarm and / or another alarm if the evaluation results in an unacceptable result, in particular if a predetermined limit is violated, if the value is below the lower limit or above the upper limit, if the range of acceptable values ​​is not met, or if a predetermined value is exceeded.

[16] The medical treatment device according to any one of

[12] to

[15] , having a second storage device configured to store the final pressure or the determined pressure difference in the second storage device.

[17] The medical treatment apparatus according to any one of

[12] to

[16] , comprising a device configured to determine, for example calculate, a wear curve from the stored values.

[18] The medical treatment device according to any one of

[12] to

[17] , wherein the container comprises or consists of a section of the used water branch of a balancing system.

[19] A medical treatment device according to any one of

[12] to

[18] , wherein the container is or includes a section within a liquid line of a liquid system, particularly a dialysis fluid system.

[20] The medical treatment apparatus according to any one of

[12] to

[19] , wherein the transport device is an ultrafiltration pump, a bicarbonate pump, or a sodium pump.

[21] The medical treatment apparatus according to any one of

[12] to

[20] , wherein the conveying device is a positive displacement pump, in particular a membrane pump, an eccentric membrane pump, a tube pump, a roller pump, or a piston pump.

[22] A medical treatment device according to any one of

[12] to

[21] , which is designed as a blood treatment device, in particular as a hemodialysis device, a hemofiltration device, a hemodiafiltration device, or as a device for carrying out a separation method.

[23] A digital storage medium, in particular in the form of a floppy disk, CD or DVD, or EPROM, having electronically readable control signals configured to configure a control device or closed-loop control device into a control device or closed-loop control device according to the invention and / or to configure a medical treatment apparatus into a medical treatment apparatus according to the invention, whereby the methods according to any one of [1] to

[10] can be initiated or performed, respectively.

[24] A computer program product having program code stored on a machine-readable storage medium configured to configure a control device or a closed-loop control device into a control device or a closed-loop control device according to the present invention, and / or to configure a medical treatment apparatus into a medical treatment apparatus according to the present invention, thereby initiating or executing the method according to any one of [1] to

[10] , respectively.

[25] A computer program having program code for configuring a control device or a closed-loop control device into a control device or a closed-loop control device according to the present invention, and / or for configuring a medical treatment apparatus into a medical treatment apparatus according to the present invention, thereby enabling the method according to any one of [1] to

[10] to be started or executed, respectively. [Explanation of symbols]

[0154] 100...Medical treatment device 1...Outlet valve 2...Inlet valve 3...Transportation room 4...Membrane 5...Eccentric 6...Connecting rod 7...Pump drive 10...Dialysis fluid system 29...Control device or closed-loop control device 31...First storage device 33...Second storage device 35...Readout device 37...Decision device 39...Evaluation device 71...Container 71'...Container 73…Liquid source F1...first delivery device, here illustratively a bicarbonate pump F2: a second transport device, here illustratively a sodium pump F3: a third transport device, here illustratively an ultrafiltration pump FB...Transportation exercise DS... Pressure gauge, pressure measuring device DS1...Pressure gauge TS...thermometer, temperature sensor C1: First concentrate container C2: Second concentrate container H1...heating device P_0: Initial pressure P_1...Final pressure P_R...reference value ΔP…(pressure) difference t...hour V03...Valve V05...Valve V07...Valve V09...Valve V11...Valve V13...Valve V15...Valve V17...Valve V25...Valve VB1, VB2...Valves VS1, VS2... valves

Claims

1. 1. A method for checking the functionality of a delivery device of a medical treatment apparatus for extracorporeal blood treatment, comprising: - providing a container filled with a liquid, said container being in fluid or conveying communication with said conveying device; - setting a predetermined initial pressure in the container filled with liquid; - controlling said conveying device to convey said liquid from said container for a predetermined number of conveying movements; - after completion of the predetermined number of conveying movements of the conveying device, measuring the pressure that arises in the container using pressure measurement and defining the measured pressure as a final pressure; - reading from the first storage device a stored reference value, which is a reference pressure or a reference pressure difference; determining the pressure difference between the measured final pressure and the stored reference value, or determining the pressure difference between the difference between the initial pressure and the final pressure on the one hand and the stored reference value on the other hand; - evaluating said determined pressure difference; A method comprising:

2. - further comprising the step of setting a predetermined temperature in said container with the aim of reaching or achieving a predetermined condition while measuring said pressure; The method of claim 1.

3. The evaluating step includes: - comprising or consisting in determining whether said determined pressure difference is within predetermined limits, above or below a limit value, above a minimum value and / or below a maximum value, 3. The method according to claim 1 or 2.

4. - comprising the further step of outputting an acoustic and / or optical alarm if said evaluating step produces a result that is predefined as unacceptable, The method according to any one of claims 1 to 3.

5. - comprising the further step of storing said final pressure or said determined pressure difference in a second storage device, The method according to any one of claims 1 to 4.

6. - comprising the further step of determining a wear curve from said stored values, The method of claim 5.

7. A method according to any preceding claim, wherein the container comprises or consists of a section of a spent water branch of a balancing system.

8. The method of any one of claims 1 to 7, wherein the container is or comprises a section in a liquid line of a dialysate system.

9. The method of any one of claims 1 to 8, wherein the delivery device is an ultrafiltration pump, a bicarbonate pump, or a sodium pump.

10. The method according to any one of claims 1 to 9, wherein the at least one conveying device is a positive displacement pump, an eccentric membrane pump, a tube pump, a roller pump, or a piston pump.

11. A control device or closed-loop control device configured to interact with a medical treatment apparatus to initiate or carry out the method of any one of claims 1 to 10.

12. A medical treatment device comprising at least: a liquid system; a pressure measuring device for measuring the pressure occurring in said container; a first storage device in which a reference value is stored, the reference pressure or the reference pressure difference; a read-out device configured to read out said stored reference values; a determination device for determining the pressure difference between the measured final pressure and the stored reference value, or for determining the pressure difference between the difference between the initial pressure and the final pressure on the one hand and the stored reference value on the other hand; an evaluation device configured to evaluate said determined pressure difference; at least one conveying device in fluid or conveying communication with said container; a control device or closed-loop control device according to claim 11, configured to initiate the execution of a method according to any one of claims 1 to 10; 1. A medical treatment device comprising or connected to:

13. 13. The medical treatment apparatus of claim 12, comprising a heating device configured to heat the liquid that is or will be filled in the container to a predetermined temperature in order to achieve predetermined conditions within the container during the pressure measurement being performed.

14. 14. The medical treatment apparatus of claim 12 or 13, comprising a device configured to determine whether the determined pressure differential is within predetermined limits, above or below a limit value, above a minimum value, and / or below a maximum value.

15. 15. The medical treatment apparatus according to claim 12, further comprising a device for outputting an alarm, said device being configured to output an acoustic alarm and / or an optical alarm and / or another alarm if said evaluation leads to an unacceptable result.

16. 16. The medical treatment apparatus of claim 12, further comprising a second storage device configured to store the final pressure or the determined pressure difference in a second storage device.

17. A medical treatment apparatus according to any one of claims 12 to 16, comprising a device configured to determine a wear curve from the stored values.

18. A medical procedure device according to any one of claims 12 to 17, wherein the container comprises or consists of a section of the spent water branch of a balancing system.

19. A medical treatment device according to any one of claims 12 to 18, wherein the container is or comprises a section within a liquid line of a liquid system.

20. The medical treatment apparatus of any one of claims 12 to 19, wherein the delivery device is an ultrafiltration pump, a bicarbonate pump, or a sodium pump.

21. The medical treatment apparatus of any one of claims 12 to 20, wherein the delivery device is a positive displacement pump, an eccentric membrane pump, a tube pump, a roller pump, or a piston pump.

22. The medical treatment device according to any one of claims 12 to 21, which is designed as a blood treatment device.

23. A digital storage medium storing an electronically readable program adapted to configure a control device or closed-loop control device into a control device or closed-loop control device according to the invention and / or to configure a medical treatment apparatus into a medical treatment apparatus according to the invention, thereby causing a computer to start or carry out a method according to any one of claims 1 to 10.

24. A computer program for configuring a control device or a closed-loop control device into a control device or a closed-loop control device according to the invention and / or for configuring a medical treatment apparatus into a medical treatment apparatus according to the invention, the computer program causing a computer to start or to carry out a method according to any one of claims 1 to 10.

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