METHOD FOR CHECKING THE FUNCTIONALITY OF CONVEYING DEVICES OF A MEDICAL TREATMENT APPARATUS, AND APPARATUSES

Abstract

The present disclosure relates to a method for checking the functionality of conveying devices of a medical treatment apparatus. It further relates to a control device and/or closed-loop control device and to a medical treatment apparatus through which the method according to the present disclosure is effected, to a digital storage medium, a computer program product and to a computer program.

Claims

1.-20. (canceled)

21. A method for checking a functionality of a conveying device of a medical treatment apparatus for an extracorporeal blood treatment, the method comprising: providing a container filled with liquid, wherein the container is in fluid communication or conveying communication with the conveying device; setting a predetermined initial pressure (P_0) inside the container; controlling the conveying device to perform a predetermined number of conveying movements; after completion of the predetermined number of conveying movements of the conveying device, measuring a pressure prevailing in the container using a pressure measuring device and defining the measured pressure as a final pressure (P_1); receiving, from a first storage device, a stored reference value (P_R) comprising a reference pressure or a reference pressure difference; determining a pressure difference (ΔP), wherein the pressure difference (ΔP) equals either: a difference between the final pressure (P_1) and the stored reference value (P_R), or a difference between: (i) a difference between the initial pressure (P_0) and the final pressure (P_1) and (ii) a difference between the initial pressure (P_0) and the stored reference value (P_R); and evaluating the determined pressure difference (ΔP).

22. The method of claim 21, further comprising: setting a predetermined temperature inside the container to reach or achieve a predetermined state while measuring the pressure.

23. The method of claim 21, wherein evaluating the determined pressure difference (ΔP) comprises: determining whether the determined pressure difference (ΔP) lies within predetermined limits, exceeds or falls below a limit value, exceeds a minimum value, or does not exceed a maximum value.

24. The method of claim 21, further comprising: outputting an acoustic alarm or an optical alarm in response to determining at least one of (i) results of evaluating the determined pressure difference (ΔP) correspond to results defined as inadmissible in advance, (ii) predetermined limits are violated by the determined pressure difference (ΔP), (iii) the pressure difference (ΔP) falls below a lower limit value or exceeds an upper limit value, (iv) an admissible value range is exceeded by the determined pressure difference (ΔP), or (v) a predetermined amount is exceeded by the determined pressure difference (ΔP).

25. The method of claim 21, further comprising: storing the final pressure (P_1) or the determined pressure difference (ΔP) in a second storage device.

26. The method of claim 25, further comprising: determining a wear curve from values stored on the second storage device.

27. The method of claim 21, wherein the container comprises sections of a used water branch of a balancing system.

28. The method of claim 21, wherein the container comprises a section in a liquid line of a dialysis liquid system.

29. The method of claim 21, wherein the conveying device is an ultrafiltration pump, a bicarbonate pump, or a sodium pump.

30. The method of claim 21, wherein the conveying device is a displacement pump, a membrane pump, an eccentric membrane pump, a tube pump, a roller pump, or a piston pump.

31. A control device or a closed-loop control device configured to initiate or carry out, in interaction with a medical treatment apparatus, a method comprising: setting a predetermined initial pressure (P_0) inside a container filled with liquid, wherein the container is in fluid communication or conveying communication with a conveying device; controlling the conveying device to perform a predetermined number of conveying movements; after completion of the predetermined number of conveying movements of the conveying device, measuring a pressure prevailing in the container using a pressure measuring device and defining the measured pressure as a final pressure (P_1); receiving, from a first storage device, a stored reference value (P_R) comprising a reference pressure or a reference pressure difference; determining a pressure difference (ΔP), wherein the pressure difference (ΔP) equals either: a difference between the final pressure (P_1) and the stored reference value (P_R), or a difference between: (i) a difference between the initial pressure (P_0) and the final pressure (P_1) and (ii) a difference between the initial pressure (P_0) and the stored reference value (P_R); and evaluating the determined pressure difference (ΔP).

32. A medical treatment apparatus comprising or connected to at least: a liquid system comprises a container for liquid; a pressure measuring device for measuring a pressure prevailing in the container, the measured pressure being defined as a final pressure (P_1); a first storage device storing a reference value (P_R), wherein the reference value (P_R) a reference pressure or a reference pressure difference; a read-out device configured to read out the reference value (P_R) stored on the first storage device; a determining device for determining a pressure difference (ΔP) corresponding to (i) a difference between the final pressure (P_1) and the reference value (P_R), (ii) a difference between a predetermined initial pressure (P_0) inside the container and the final pressure (P_1), or (iii) a difference between the initial pressure (P_0) and the reference value (P_R); an evaluation device configured to evaluate the determined pressure difference (ΔP); at least one conveying device in fluid communication or conveying communication with the container); and a control device or closed-loop control device configured to initiate execution of a method comprising: setting a predetermined initial pressure (P_0) inside the container; controlling the at least one conveying device to perform a predetermined number of conveying movements; after completion of the predetermined number of conveying movements of the conveying device, measuring a pressure prevailing in the container using the pressure measuring device and defining the measured pressure as a final pressure (P_1); receiving, from the first storage device, a stored reference value (P_R) comprising a reference pressure or a reference pressure difference; determining a pressure difference (ΔP), wherein the pressure difference (ΔP) equals either: a difference between the final pressure (P_1) and the stored reference value (P_R), or a difference between: (i) a difference between the initial pressure (P_0) and the final pressure (P_1) and (ii) a difference between the initial pressure (P_0) and the stored reference value (P_R); and evaluating the determined pressure difference (ΔP).

33. The medical treatment apparatus of claim 32, comprising a heating device configured to heat a liquid with which the container is being filled or will be filled to a predetermined temperature to achieve a predetermined state in the container during the pressure measuring.

34. The medical treatment apparatus of claim 32, further comprising a device configured for determining whether the determined pressure difference (ΔP) lies within predetermined limits, exceeds or falls below a limit value, exceeds a minimum value, or does not exceed a maximum value.

35. The medical treatment apparatus of claim 32, further comprising a device for outputting an alarm, the device being configured to output an acoustic alarm or an optical alarm or another alarm in response to determining at least one of (i) results of evaluation of the determined pressure difference (ΔP) correspond to inadmissible results, (ii) predetermined limits are violated by the determined pressure difference (ΔP), (iii) the determined pressure difference (ΔP) falls below a lower limit value or exceeds an upper limit value, (iv) an admissible value range is not met by the determined pressure difference (ΔP), or (v) a predetermined value is exceeded by the determined pressure difference (ΔP).

36. The medical treatment apparatus of claim 32, further comprising a second storage device configured to store the final pressure (P_1) or the determined pressure difference (ΔP) in the second storage device.

37. The medical treatment apparatus of claim 36, further comprising a device configured to determine a wear curve from the values stored on the second storage device.

38. The medical treatment apparatus of claim 32, wherein the container comprises sections of a used water branch of a balancing system.

39. The medical treatment apparatus of claim 32, wherein the container comprises a section in a liquid line of the liquid system.

40. The medical treatment apparatus of claim 32, wherein the conveying device is an ultrafiltration pump, a bicarbonate pump or a sodium pump.

41. The medical treatment apparatus claim 32, wherein the conveying device is a displacement pump, a membrane pump, an eccentric membrane pump, a tube pump, a roller pump, or a piston pump.

42. The medical treatment apparatus of claim 32, wherein the medical treatment apparatus comprises s a hemodialysis apparatus, a hemofiltration apparatus, a hemodiafiltration apparatus, or an apparatus for carrying out a separation method.

43. A computer-readable storage medium comprising instructions for execution of a method according to claim 21.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0114] The present disclosure is described below on the basis of preferred embodiments thereof with reference to the attached drawing. The method according to the present disclosure and the blood treatment apparatus according to the present disclosure are described using the example of a hemodialysis apparatus. The method according to the present disclosure may however also be used in the same way in other blood treatment apparatuses, for example a hemodiafiltration apparatus. In the figures, the following applies:

[0115] FIG. 1 shows parts of a line diagram of a liquid system of a medical treatment apparatus according to the present disclosure in a first embodiment;

[0116] FIG. 1a shows section A of the liquid system of the medical treatment apparatus of FIG. 1, including the container shown in FIG. 1;

[0117] FIG. 1b shows an alternative container, which is suitable for checking alternative conveying device with respect to FIG. 1;

[0118] FIG. 2 shows, schematically simplified, the course of the method according to the present disclosure on the basis of the devices used for this purpose;

[0119] FIG. 3 shows, schematically simplified, an eccentric membrane pump as an exemplary embodiment of a conveying device; and

[0120] FIG. 4 shows an exemplary course of the method according to the present disclosure in a pressure/conveying movement diagram.

DETAILED DESCRIPTION

[0121] FIG. 1 shows parts of a line diagram of a dialysis liquid system 10 (also referred to as hydraulics)—as an example of a liquid system—of a medical treatment apparatus 100 according to the present disclosure in a first embodiment, here purely optionally of a blood treatment apparatus.

[0122] The dialysis liquid system 10 comprises a plurality of pumps, valves, actuators, sensors and other components. All of them may be independently connected in signal communication to a control device or closed-loop control device 29 of the medical treatment apparatus 100 and may optionally be controlled and/or read-out by it.

[0123] The pumps mentioned above include amongst others a first conveying device F1, here a bicarbonate pump, a second conveying device F2, here a sodium pump, as well as the ultrafiltration pump designated here as conveying device F3.

[0124] The pumps are integrated in fluid communication with each other in the dialysis liquid system 10. The conveying device F3 is fluidically connected to a ventilation device and to a temperature sensor TS as well as to a pressure sensor DS via the lines which are extracted in FIG. 1a and shown here and in FIG. 1a in bold. The lines connecting them are fluidically separated from an outside by the (halted) conveying 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 conveying device F3 and the valves V11, V13, V15, V17 and V25 thus results in a closed vessel or a compound of closed but communicating lines, in particular line sections, or vessels, and is referred to herein as a container. Other designations, such as volume, receiving section for liquid, etc., would also be conceivable in the context of the present disclosure instead of “container”.

[0125] The container shown in FIG. 1a while omitting those elements from FIG. 1 that are not involved in creating its closed volume, is referred to herein as container 71, see FIG. 1a.

[0126] The conveying device F3 is arranged with respect to the container 71 such that it may convey the liquid that is present in the container 71 out of the latter, which it also does in the course of the method according to the disclosure in an exemplary embodiment described below.

[0127] The pressure gauge DS arranged in the container by which e.g. the pressure measuring may be carried out, may optionally have the highest measuring accuracy of all pressure gauges measuring in the container, like any other pressure sensor used. The utilized pressure gauge may be an analog-digital converter (ADC).

[0128] The control device or closed-loop control device 29 may, in cooperation with the temperature sensor TS and a heating device H1, regulate the internal temperature of the container 71 to a predetermined temperature. The predetermined temperature may correspond to a temperature at which a reference value P R (see FIG. 4) was determined during production of the conveying device and may have a value in degrees Celsius (C.°).

[0129] The medical treatment apparatus may encompass other valves, for example the V03, V05, V07 or V9. The container 71 may if necessary be expanded and/or relocated by these valves, for example to check a different conveying device F1, F2 than the conveying device F3 of the example described above. An expanding is to be understood such that the container 71 encompasses more line sections of the treatment system 100 than in the example described above. Relocating is to be understood such that the container 71 encompasses other line sections of the treatment system 100 than in the example described above, as shown in FIG 1b.

[0130] FIG. 1a shows the container from FIG. 1. Components of FIG. 1 that are not involved in the creation of the closed container 71 are not shown again in FIG. 1a for a better overview.

[0131] For filling it, the container 71 is filled in some embodiments using a liquid source 73 (see FIG. 1a) via hydraulic lines. The liquid source 73 may be or may comprise a source for water, in particular a water tap or a water line, optionally with subsequent devices for cleaning or degassing. In other embodiments, the refilling may optionally be done from an external sealed or closed source, for example a liquid bag. The method according to the present disclosure may encompass filling or may only begin when a filled container 71 is present.

[0132] The filling defines an initial pressure P_0 within the container 71, which may be controlled or set by using the liquid source 73, alternatively or additionally, for example, via valve V13, especially if the filling has been carried out by a pump in an undefined way. The other valves, which delimit the container 71, are hereby optionally closed.

[0133] Optionally, each valve connected to the container 71 may, for this purpose, be opened and closed again for filling; the other valves of the container 71 are preferably closed.

[0134] FIG. 1 and FIG. 1a are mainly dedicated to the conveying device F3. This is purely exemplary. What is stated here for F3 can also apply analogously to F1 and/or F2 (see FIG. 1b).

[0135] FIG. 1b shows in the line diagram of the dialysis liquid system 10 from FIG. 1 an alternative container 71′, which is suitable for checking the conveying devices F1, F2.

[0136] For this purpose, the valves VB2, VS2 and V09 are closed. If necessary, valves VB1 and VS1 will allow or enable access to the pressure sensor DS1.

[0137] The statements made above about the container 71 also apply analogously undiminished to the container 71′.

[0138] The liquid for filling the container 71′ may originate from the liquid source 73 shown at the top left.

[0139] FIG. 2 shows, in a schematically simplified manner, the course of the method according to the present disclosure on the basis of the devices used for this purpose.

[0140] At the top left in FIG. 2, an exemplary medical treatment apparatus 100 with a dialysis liquid system 10 is shown in a highly simplified schematic manner. The control device or closed-loop control device 29 may be configured to effect in cooperation with the temperature sensor TS and the heating device H1 a predetermined internal temperature of the container 71, 71′. By activating the valves (not shown in FIG. 2) or the conveying devices F1, F2, F3 by the control device or closed-loop control device 29, a predetermined initial pressure P_0 may be set in the interior of the container 71, 71′; this may possibly be controlled by the pressure sensor DS.

[0141] In order to check it, the conveying device F3, here the ultrafiltration pump, is induced by the control device or closed-loop control device 29 to execute 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 five strokes.

[0142] After completion of the predetermined number of conveying movements FB, the pressure inside the container 71, 71′ is measured by the pressure gauge DS. It may be transmitted, in particular by the control device or closed loop control device 29, to the optionally available second storage device 33 to be stored therein.

[0143] The reference value P_R, which corresponds to the conveying device F3 and is stored in the first storage device 31, and which may be a reference pressure or a reference pressure difference, is read out by the read-out device 35.

[0144] The determining device 37 may be configured to determine a pressure difference ΔP between the measured final pressure P_1 and the stored reference pressure P_R. Alternatively, it may be provided that a pressure difference ΔP is determined between a difference between initial pressure P_0 and final pressure P_1 on the one hand and the stored reference value P_R, which in this case is a reference pressure difference, on the other hand.

[0145] An evaluating device 39 may be configured to evaluate the determined pressure difference ΔP. It may be provided to transmit the result of the evaluation to the medical treatment apparatus 100, in particular to its control device or closed-loop control device 29.

[0146] The medical treatment apparatus 100 or the control device or closed-loop control device 29 may in particular be provided to activate an optional alarm device (not shown in FIG. 2) if the amount of the determined pressure difference ΔP is e.g. outside predetermined limits or otherwise does not meet a predetermined criterion.

[0147] FIG. 3 shows, in a schematically simplified manner, an eccentric diaphragm pump as an exemplary embodiment of the conveying device F1, F2 or F3 in a schematic representation.

[0148] An elastic membrane 4 is moved up and down by an eccentric 5 and a connecting rod 6.

[0149] In the downward stroke it sucks in the fluid to be conveyed via an inlet valve 2. In the upward stroke, the membrane 4 pushes the fluid out of the pump head via an outlet valve 1. A downward stroke, an upward stroke, or a combination of exactly one downward stroke with exactly one subsequent upward stroke may each correspond to a conveying movement FB.

[0150] A conveying room 3 is hermetically separated from a pump drive 7 by the membrane 4.

[0151] According to the present disclosure, the pressure generated in the conveying room 3 is a negative pressure (underpressure), by which a tearing of the membrane 4 of the conveying device may advantageously be recognized, since in the case of underpressure, the membrane 4 is prevented from resting on the plunger. If an overpressure were to prevail in conveying room 3, it would always force the membrane 4 against the plunger and a tearing could remain undetected in such a case.

[0152] FIG. 4 shows an exemplary course of the method according to the present disclosure in a pressure [P] over a number of conveying movements [FB] diagram, wherein reference is made to the arrangement of FIG. 1 and FIG. 1a.

[0153] In FIG. 4, the following applies:

[0154] P_0 is the predetermined initial pressure, an absolute pressure; P_0 may be measured by a pressure measuring using an absolute pressure gauge, it may be calculated or known from or based on other circumstances.

[0155] P_1 is the pressure prevailing in container 71 after the completion of the conveying movement of the conveying device in question and is referred to herein as final pressure.

[0156] P_R is a negative reference value for the pressure (underpressure) in the container 71, i.e. a 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 at the factory under at least one defined state of the container or at least one defined general condition. A general condition may be for example an internal temperature of the container 71, wherein it may also be provided here to define a narrow temperature range as permissible.

[0157] The method begins after the initial pressure P_0 in the container 71 is set to the initial pressure P_0 at optionally a defined or predetermined internal temperature or within a predetermined, narrow temperature range (see FIG. 1), which may be done by the liquid source 73 and at least one conveying device of the medical treatment apparatus 100 and may be checked if necessary by the pressure gauge DS or the temperature gauge TS, respectively.

[0158] The conveying device F3 conveys liquid out of the container 71, here exemplarily in ten strokes, which is why the pressure gauge DS or another pressure sensor detects a drop in the pressure prevailing in the container 71 down to P_1, the final pressure, after completion of conveyance by the conveying device F3, i.e. after ten strokes.

[0159] In the example shown, there is a pressure difference ΔP between the final pressure P_1 and an already stored reference value P_R. In this example, the reference value P_R stands for a pressure that was (pre)determined (by the factory) after 10 strokes by way of example.

[0160] The determined final pressure P_1 lies above the clearly more negative reference value P_R, here exemplarily an underpressure, in other embodiments it could also be an overpressure. An alarm may be provided for the case that the amount of the pressure difference ΔP exceeds a certain value, leaves a permissible value range, or violates another criterion. Such an alarm may occur acoustically or optically or, in some embodiments, could already include the indication that the conveying device F3 is at least limited in terms of its functionality.

[0161] 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).

[0162] It may be provided to calculate a wear curve from several final pressures P_1 or pressure differences ΔP over time and to store it if necessary. The wear curve may be stored such that it may be read out or displayed by a service technician at any time.

List of Reference Numerals

[0163] 100 medical treatment apparatus [0164] 1 outlet valve [0165] 2 inlet valve [0166] 3 conveying room [0167] 4 membrane [0168] 5 eccentric [0169] 6 connecting rod [0170] 7 pump drive [0171] 10 dialysis liquid system [0172] 29 control device or closed-loop control device [0173] 31 first storage device [0174] 33 second storage device [0175] 35 read-out device [0176] 37 determining device [0177] 39 evaluation device [0178] 71 container [0179] 71′ container [0180] 73 liquid source [0181] F1 first conveying device, here exemplarily: bicarbonate pump [0182] F2 second conveying device, here exemplarily: sodium pump [0183] F3 third conveying device, here exemplarily: ultrafiltration pump [0184] FB conveying movements [0185] DS pressure gauge, pressure measuring device [0186] DS1 pressure gauge [0187] TS temperature gauge, temperature sensor [0188] C1 first concentrate container [0189] C2 second concentrate container [0190] H1 heating device [0191] P_0 initial pressure [0192] P_1 final pressure [0193] P_R reference value [0194] ΔP (pressure) difference [0195] t time [0196] V03 valve [0197] V05 valve [0198] V07 valve [0199] V09 valve [0200] V11 valve [0201] V13 valve [0202] V15 valve [0203] V17 valve [0204] V25 valve [0205] VB1, VB2 valves [0206] VS1, VS2 valves