MEDICAL TREATMENT DEVICE AND PROCEDURE

Description

[0001] The present invention relates to a method according to claim 1, a control device according to claim 11 and a medical or medical-technical treatment device according to claim 12.

[0002] Medical devices that supply fluid to an external, replaceable component, such as a blood filter or dialyzer, via a first line and discharge it via a second line, regularly feature a bypass line in practice. This bypass line serves to connect the first line to the second line without the aforementioned component being involved in the resulting short-circuit fluid paths, for example, for flushing the system, the two lines, etc.

[0003] Methods for checking the condition of a short-circuit line connected to a dialysis fluid inlet line and a dialysis outlet line are known, for example, from US5589070 A.

[0004] One object of the present invention is to provide a further method for checking the condition of a short-circuit line, a further control device and a further medical treatment device.

[0005] The problem according to the invention is solved by a method with the features of claim 1, a control device with the features of claim 11 and by a medical treatment device with the features of claim 12.

[0006] According to the invention, a short-circuit line is used to establish a fluid connection between at least one first line, e.g. a dialysis fluid inlet line, and a second line, z. B. proposed for a dialysate drainage line of a treatment device, e.g. a blood treatment device, in particular a dialysis device.

[0007] In normal use, the dialysis fluid inlet line is used to direct dialysis fluid from inside the treatment device to an outside of the treatment device.

[0008] In normal use, dialysate is returned from the outside to the inside of the treatment device via the dialysate drain line.

[0009] The short-circuit line according to the invention has a first connector. It serves to connect the short-circuit line to a first connector of the dialysis fluid supply line, thereby establishing a fluid connection between the short-circuit line and the dialysis fluid supply line.

[0010] The short-circuit line also has a second connector. This serves to connect the short-circuit line to a second connector of the dialysate drain line, again establishing a fluid connection.

[0011] Furthermore, the short-circuit line has at least one backflow preventer, in particular a check valve, which allows fluid to flow through the short-circuit line only or essentially only in the direction from the first connector to the second connector.

[0012] The aforementioned first and second connectors are, in preferred embodiments, the only connectors of the short-circuit line.

[0013] According to the invention, a method for checking the condition of a short-circuit line according to the invention is proposed, which is connected to a dialysis fluid inlet line and a dialysate outlet line of a provided medical treatment device. The medical treatment device has a dialysis fluid inlet line with a connector for connecting the dialysis fluid inlet line to a blood filter of the medical treatment device. Furthermore, the medical treatment device has a dialysate outlet line with a connector for connecting the dialysate outlet line to the blood filter. Additionally, the medical treatment device has a pumping device for pumping fluid within the dialysis fluid inlet line and / or within the dialysate outlet line.

[0014] The procedure should be carried out when or after the short-circuit line has been connected to the connector of the dialysate inlet line by means of its first connector and to the connector of the dialysate outlet line by means of its second connector.

[0015] The method according to the invention comprises actuating the conveying device, in particular in an attempt or with the aim of conveying fluid within or along the dialysis fluid inlet line and / or within or along the dialysate outlet line in order to build up pressure or vacuum within the dialysis fluid inlet line and / or within the dialysate outlet line.

[0016] The procedure further comprises, at one and / or for a first point in time, measuring or otherwise determining the pressure prevailing within the dialysis fluid inlet line and / or within the dialysate outlet line. This pressure is also referred to herein as the outlet pressure.

[0017] Furthermore, the procedure includes determining at least one pressure value based on the measured pressure, for example as a numerical value with the dimension mbar, hPa, mmHg or the like, in the form of an absolute value, a relative value, a difference, etc.

[0018] The procedure further includes evaluating at least one pressure value, for example according to predetermined criteria.

[0019] Furthermore, the procedure includes the transmission or output of a signal which indicates the state of the short-circuit line and is a result of the evaluation.

[0020] According to the invention, a control device is further proposed which is programmed to perform a test or method for checking the condition of a short-circuit line, preferably according to the invention, provided that the short-circuit line is connected by means of the aforementioned connectors to both the dialysis fluid inlet line and the dialysate outlet line of a medical blood treatment device. The test comprises the steps of the method according to the invention in any embodiment.

[0021] According to the invention, a medical treatment device is further proposed, which has a housing which preferably separates an interior and an exterior of the treatment device, and preferably a short-circuit line according to the invention.

[0022] The invention is defined by the features of independent claims 1 and 11. Advantageous embodiments of the present invention are also the subject of the dependent claims.

[0023] In all the preceding or following statements, the use of the expression "may be" or "may have" etc. is to be understood as synonymous with "is preferably" or "has preferably" etc. and is intended to explain embodiments according to the invention.

[0024] Whenever numerical terms are used herein, a person skilled in the art understands them to indicate a lower numerical limit. Unless this leads to a contradiction apparent to a person skilled in the art, they will always interpret the terms "a" or "a" as meaning "at least one" or "at least one." This understanding is encompassed by the present invention, as is the interpretation that a numerical term such as "a" can alternatively be meant as "exactly one," wherever this is technically feasible to a person skilled in the art. Both are encompassed by the present invention and apply to all numerical terms used herein.

[0025] Whenever spatial references such as "top", "bottom", "upper" or "lower" are mentioned herein, the person skilled in the art shall, in case of doubt, understand these as a spatial indication with reference to the orientation in the figures attached herein and / or the arrangement of the short-circuit line according to the invention in its intended use.

[0026] Whenever an embodiment is mentioned herein, this always represents an exemplary embodiment according to the invention, which is not to be understood as limiting.

[0027] The invention is defined by the features of independent claims 1 and 11.

[0028] Whenever a suitability or a process step is mentioned herein, the present invention also includes a corresponding programming or configuration of a device suitable and / or programmed for this purpose or for carrying out the process step, or of a section thereof.

[0029] When a point in time is mentioned here, this can alternatively refer to a period of time.

[0030] According to the claimed invention, the result of the evaluation includes a faulty connection of the short-circuit line to the dialysis fluid inlet line and / or the dialysate outlet line. In further embodiments, the result is or includes an indication thereof.

[0031] Alternatively or additionally, evaluating the at least one pressure value includes comparing it with a reference value or range, for example, a first reference value. In each of the embodiments described herein, a faulty connection can be inferred as a result, or is inferred if the evaluation of the pressure value, the evaluation of a difference between several pressure values, and / or the comparison of pressure values ​​determined for different lines shows that a defined or predetermined reference value is exceeded or that the pressure value lies outside a defined or predetermined reference range.

[0032] Reference values ​​and / or reference ranges can be designed in certain embodiments in such a way that a faulty connection can be concluded as a result if the evaluation as described above shows that a defined or predetermined reference value is undershot or the pressure value is within a defined or predetermined reference range.

[0033] In some embodiments, a fault-free connection can be inferred, or is inferred, if the evaluation of the pressure value shows that it does not exceed a reference value, e.g., the first reference value, or lies within, for example, the first, reference range, or vice versa. Reference values ​​or ranges can be, include, or be limited by limit values.

[0034] According to the claimed invention, the result is a malfunction of the reverse current protection of the short-circuit line. In further embodiments, the result is or includes an indication thereof.

[0035] Alternatively or additionally, the result is that a faulty connection exists. This can be caused by, be a consequence of, or require a connection between the connector of the dialysis fluid inlet line and the second connector of the bypass line, which should be connected to the dialysate outlet line, or between the connector of the dialysate outlet line and the first connector of the bypass line, which should be connected to the dialysis fluid inlet line.

[0036] In some embodiments of the method according to the invention, when determining the pressure value, both the pressure prevailing in the dialysis fluid inlet line at the first time point and the pressure prevailing in the dialysate outlet line at the first time point are or were measured. In these, or other, embodiments, a pressure difference is preferably determined between the pressure or pressure value measured in the dialysis fluid inlet line and the pressure or pressure value measured in the dialysate outlet line, or vice versa.

[0037] In these embodiments, evaluating the at least one pressure value includes comparing this pressure difference, for example, with a second reference value or range for this purpose.

[0038] In certain embodiments, a faulty connection can be inferred if the evaluation of the pressure value shows that the pressure value exceeds the second reference value or is outside the second reference range.

[0039] In some embodiments, the method according to the invention comprises, as a further step, measuring the pressure prevailing in the dialysis fluid inlet line and / or in the dialysate outlet line at a second time point, which is temporally elapsed after the first time point. It additionally comprises determining at least a second pressure value based on this measurement.

[0040] In these embodiments, the evaluation of the pressure value is or comprises a comparison of the pressure difference between the pressures measured in the dialysis fluid inlet line at the first and second time points or pressure values ​​determined thereon, and / or a comparison of the pressure difference between the pressures measured in the dialysis outlet line at the first and second time points or pressure values ​​determined thereon, preferably taking into account the outlet pressures, with one, for example, a third or fourth, reference value or range for this purpose.

[0041] In certain embodiments, a faulty connection can be inferred if the evaluation of the pressure values ​​is or includes the finding that at least one of them exceeds the third or fourth reference value or lies outside the third or fourth reference range.

[0042] In some embodiments, the pumping device is actuated with the aim of generating a vacuum in both the dialysis fluid inlet line and the dialysate outlet line. The inventive method additionally includes the further step of releasing the generated vacuum in the dialysate outlet line.

[0043] In these embodiments, measuring a pressure prevailing in the dialysis fluid inlet line and / or in the dialysate outlet line includes measuring at one or more time points after decompression.

[0044] In some embodiments, the actuation of the at least one pumping device and / or the build-up of overpressure or underpressure occurs when a first valve is open, which is located upstream of the connector of the dialysis fluid inlet line, but downstream of the first pressure sensor. Alternatively or additionally, the actuation or build-up occurs when a second valve is open, which is located downstream of the second connector of the dialysis fluid outlet line, but upstream of the second pressure sensor.

[0045] In some embodiments, the reduction of the negative pressure prevailing in the dialysate drain line is preferably achieved by connecting the dialysate drain line to a fresh water source or a drain, or includes this connection.

[0046] Even more preferably, the negative pressure is relieved by opening a valve to a fresh water line or a valve to a drain or discharge line, or includes this opening.

[0047] In some embodiments, the signal emitted or output is associated with or encoded for a faulty state of the short-circuit line.

[0048] This can be the case, in particular, if the evaluation of the pressure value reveals or includes an exceedance of a reference value or a deviation from a reference range. Alternatively or additionally, it can occur if determining the pressure value based on measured pressures taken after decompression within the dialysis fluid inlet line reveals a pressure increase.

[0049] In some embodiments, the method according to the invention further comprises a fluidic shut-off of the dialysate drain line, or a section thereof, after the negative pressure in the dialysate drain line has been released, such that there is no longer any connection between the dialysate drain line or the section to the fresh water source or the drain.

[0050] In these embodiments, at least two pressures in the dialysate drain line are measured at two different times after it has been blocked in order to determine the at least one pressure value.

[0051] In addition, in these embodiments a signal is emitted or output which is associated with a faulty state of the short-circuit line, in particular if the evaluation of the at least one pressure value reveals a pressure change within the dialysate drain line.

[0052] In some embodiments of the medical treatment device according to the invention, the short-circuit lead can be accommodated, at least partially, inside or in the housing of the treatment device. In this case, the first connector and the second connector of the short-circuit lead are preferably accessible to the user from an external part of the treatment device for connection as described herein.

[0053] In some embodiments of the medical treatment device, it has a control device according to the invention.

[0054] Alternatively or additionally, the medical device has a dialysis fluid inlet line with a connector for connecting it to a blood filter, a dialysate outlet line with a connector for connecting it to a blood filter, and a pumping device for pumping fluid within the dialysis fluid inlet line and / or within the dialysate outlet line.

[0055] The condition of the short-circuit line according to the invention can be understood, for example, as its presence, its integrity, its correct arrangement on the medical treatment device, its correct connection with the dialysis fluid inlet line and / or with the dialysate outlet line and / or a functionality of the short-circuit line, in particular a functionality of the backflow preventer arranged in it.

[0056] In some embodiments, evaluating the at least one pressure value includes determining a change in pressure, for example by comparison with limit values, threshold values, value ranges and / or includes determining the time until a change occurs, etc.

[0057] Furthermore, in certain embodiments, the method includes evaluating the determined change based on predetermined criteria or quantities such as limit values, thresholds, value ranges and / or the duration until the, or a, predetermined pressure change has occurred, etc.

[0058] The specified criteria and sizes can, for example, be stored in a storage device, such as a medical treatment device, and read from there.

[0059] In some embodiments, the method according to the invention can, as a further step, include an optional output of the signal or a corresponding signal to the user of the medical treatment device. The signal to the user, for example visual, acoustic, or the like, can inform the user whether the evaluation, e.g., the detected change, meets or does not meet predetermined conditions.

[0060] In some embodiments, the measurement of pressures, which takes place at the first time point and / or at the second time point, and / or with which the outlet pressure or pressure prevailing within the dialysis fluid inlet line and / or within the dialysis outlet line is measured, is carried out by means of - or using - a first pressure sensor arranged upstream of the first connector in or on the dialysis fluid inlet line and / or by means of a second pressure sensor arranged downstream of the second connector in or on the dialysis outlet line.

[0061] In some embodiments, at least one conveying device is an ultrafiltration pump and / or a second flow pump, which is arranged downstream of the dialysate drain line. ist.

[0062] In some embodiments, actuating the conveying device includes building up a vacuum or pressure both upstream of the connector of the dialysis fluid inlet line and downstream of the connector of the dialysis outlet line.

[0063] In some embodiments, the actuation of the at least one conveying device at the first time can be carried out in such a way that essentially the same pressure values ​​are preferably present at the first pressure sensor and at the second pressure sensor.

[0064] In some embodiments of the medical treatment device according to the invention, a connection to the atmosphere can be established between the first time point and the second time point downstream of the second connector and / or to the dialysate drain line.

[0065] In certain embodiments of the present invention, the pumped fluid is a dialysis fluid; in some embodiments of the invention, it is a dialysis fluid produced and / or provided online by a treatment device.

[0066] The treatment device according to the invention is designed in certain embodiments as an extracorporeal treatment device, in particular as an extracorporeal blood treatment device, for example as a dialysis device, in particular as a hemodialysis device, hemofiltration device, hemodiafiltration device, etc.

[0067] The present invention further relates to a digital, in particular non-volatile, storage medium, particularly in the form of a machine-readable carrier, especially in the form of a floppy disk, memory card, CD, DVD, EPROM, FRAM (ferroelectric RAM) or SSD (solid-state drive), particularly with electronically or optically readable control signals. This can interact with a programmable computer system in such a way that a control device is configured to become a control device according to the invention, by means of which the steps of the method according to the invention, in particular the machine steps, can be initiated. Alternatively, the storage medium can be configured to interact with a conventional medical treatment device in such a way that the latter can be reprogrammed to become a medical treatment device according to the invention.

[0068] The present invention further relates to a computer program product comprising volatile, transient, or machine-readable program code or a signal waveform, which are suitable for configuring a control device into a control device according to the invention, by means of which the steps of the method according to the invention, in particular the machine steps, can be initiated when the computer program product is running on a computer. Alternatively, the computer program product can be configured to interact with a conventional medical treatment device in such a way that the latter becomes a medical device according to the invention.

[0069] The treatment device can be reprogrammed.

[0070] According to the invention, a computer program product can be understood to be, for example, a computer program stored on a carrier, an embedded system as a comprehensive system with a computer program (e.g., an electronic device with 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, runs, is stored, is executed, or is being developed.

[0071] The term "machine-readable medium," as used herein, refers in certain embodiments of the present invention to a medium containing data or information that can be interpreted by software and / or hardware. The medium may be a data carrier such as a floppy disk, CD, DVD, USB stick, flash card, SD card, and the like, as well as any other storage device or storage medium mentioned herein.

[0072] The present invention also relates to a computer program comprising program code by means of which a conventional control device can be configured into a control device according to the invention, by means of which the steps of the method according to the invention, in particular the machine steps, can be initiated. Alternatively, the computer program is suitable for interacting with a conventional medical treatment device in such a way that the latter can be reprogrammed into a medical treatment device according to the invention.

[0073] Some or all embodiments of the invention may have one, several or all of the advantages mentioned above and / or below.

[0074] An advantage of the present invention can be to reduce or completely eliminate the risk of cross-contamination from one side, e.g., the dialysate side, to the other side, e.g., the hydraulic side, of the treatment device. Since the backflow preventer allows for the detection of reversed connectors in the bypass line by monitoring the pressure curve, the need for disinfection before the next treatment can be indicated if connectors are reversed.

[0075] The present invention makes it advantageous to test the functionality of the short-circuit line and to communicate a corresponding message to the user.

[0076] All the advantages achievable with the method according to the invention can also be achieved without diminishing quality in certain embodiments of the invention using the devices according to the invention, and vice versa.

[0077] The present invention is described below with reference to the accompanying figures. In the drawing, identical reference numerals denote identical or similar elements. The following applies: Fig. 1 schematically simplified shows a fluid line structure of a medical treatment device according to the invention; Fig. 2 schematically simplified, it shows a section of the fluid piping structure of the Fig. 1 with a short-circuit line according to the invention; and Fig. 3 The schematically simplified representation shows the process of the inventive method in one embodiment.

[0078] Fig. 1 Figure 1 shows a process diagram of a medical or medical-technical treatment device 2000 according to the invention, here a blood treatment device, connected to an extracorporeal blood circuit 300, which leads to treatment via double-needle access, or using, for example, an additional Y-connector (reference numeral Y) as shown in Figure 2. Fig. 1 The system can be connected to the vascular system of the patient (not shown) via a single-needle access. The 300-unit blood circuit can optionally be contained in or on a blood cassette in sections thereof.

[0079] Pumps, actuators and / or valves in the area of ​​the blood circulation 300 are connected to the treatment device 2000 according to the invention or to a control device 150 included therein, for example.

[0080] The blood circuit 300 includes (or is connected to) an arterial patient tubing clamp 302 and an arterial connecting needle of an arterial segment or arterial patient line, blood collection line, or first line 301. The blood circuit 300 also includes (or is connected to) a venous patient tubing clamp 306 and a venous connecting needle of a venous segment, a venous patient line, blood return line, or second line 305.

[0081] A blood pump 101 is provided in or on the first line 301; a substitution pump 111 is connected to a dialysis fluid inlet line 104 for pumping fresh dialysis fluid, which has been filtered in a further filter stage (F2) (substitution fluid). A substitution line 105 can be fluidically connected to the inlet line 104. By means of the substitution pump 111, substitution can be introduced by predilution, via a predilution valve 107, or by postdilution, via a postdilution valve 109, via associated lines 107a or 109a into line sections, for example into the arterial line section 301 or into the venous line section 305 (here between a blood chamber 303b of a blood filter 303 and a venous air separation chamber or venous blood chamber 329) of the blood circulation 300.

[0082] The blood filter 303 has a blood chamber 303b connected to the arterial line section 301 and the venous line section 305. A dialysis fluid chamber 303a of the blood filter 303 is connected to the dialysis fluid inlet line 104 leading to the dialysis fluid chamber 303a and to a dialysate outlet line 102 leading away from the dialysis fluid chamber 303a, which carries dialysate, i.e., used dialysis fluid. Suitable connectors 145 and 147 are provided for this purpose on the dialysis fluid inlet line 104 and on the dialysate outlet line 102.

[0083] The dialysis fluid chamber 303a and the blood chamber 303b are separated from each other by a mostly semi-permeable membrane 303c. This membrane forms the dividing line between the blood side with the extracorporeal blood circuit 300 and the machine side with the dialysis fluid or dialysate circuit, which is located in Fig. 1 The membrane 303c is shown on the left.

[0084] The arrangement of the Fig. 1 It further comprises a valve V24, which is arranged in the dialysate inlet line 104 upstream of the first connector 145, but downstream of a first pressure sensor S03. It further comprises a valve V25, which is arranged in the dialysate outlet line 102, downstream of the second connector 147, but upstream of a second pressure sensor PS4.

[0085] The arrangement of the Fig. 1 includes an optional detector 315 for detecting air and / or blood. The arrangement of the Fig. 1 further comprises one or two pressure sensors PS1 (upstream of blood pump 101) and PS2 (downstream of blood pump 101, it measures the pressure upstream of blood filter 303 ("pre-hemofilter")) at the in Fig. 1 The locations shown are shown. Additional pressure sensors may be provided, e.g., pressure sensor PS3 downstream of venous blood chamber 329.

[0086] An optional single-needle chamber 317 comes in Fig. 1 used as a buffer and / or compensation container in a single-needle procedure in which the patient is connected to the extracorporeal blood circulation 300 via only one of the two blood lines 301, 305.

[0087] The arrangement of the Fig. 1 It also includes an optional detector 319 for detecting air bubbles and / or blood.

[0088] An optional injection site 325 for heparin may be provided.

[0089] Links in Fig. 1 A mixing device 163 is shown, which provides a predetermined mixture for the respective solution from containers A (for A concentrate via concentrate supply 166) and B (for B concentrate via concentrate supply 168) for use by the treatment device 2000. The solution contains water (e.g., heated in the heating device 162) from the water source 155 (online, e.g., as reverse osmosis water or from bags).

[0090] A pump 171, which can be described as a concentrate pump or sodium pump, is fluidically connected to and / or pumps from the mixing device 163 and a source of sodium, such as container A. An optional pump 173, which is associated with container B, for example for bicarbonate, is visible.

[0091] The optional compressor mentioned herein is in Fig. 1 not shown.

[0092] Furthermore, in Fig. 1 A drain 153 for the effluent is visible. An optional heat exchanger 157 and a first flow pump 159, suitable for degassing, complete the arrangement shown.

[0093] The pressure sensor PS4 downstream of the blood filter 303 on the water side, but preferably upstream of the ultrafiltration pump 131 in the dialysate drain line 102, can be provided for measuring the pressure in the dialysate drain line 102, for example for measuring the filtrate pressure or membrane pressure of the blood filter 303.

[0094] Blood leaving the blood filter 303 flows through an optional venous blood chamber 329, which may have a venting device 318 and may be in fluid communication with the pressure sensor PS3.

[0095] The in Fig. 1 The exemplary arrangement shown includes the control or regulating device 150. It can be connected to any of the components mentioned herein – in any case or in particular to the blood pump 101 – via a wired or wireless signal connection for the control or regulation of the treatment device 2000.

[0096] The online mixing device for the dialysis fluid allows for variation of its sodium content within certain limits, controlled by the control device 150. For this purpose, the measured values ​​obtained by conductivity sensors 163a and 163b can be taken into account. Should an adjustment of the sodium content of the dialysis fluid (sodium concentration) or of the substitute be necessary or desired, this can be achieved by adjusting the flow rate of the sodium pump 171.

[0097] Furthermore, the treatment device includes 2000 means for conveying fresh dialysis fluid and dialysate. A first valve V24 can be provided between the first flow pump 159 and the blood filter 303, which opens or closes the inlet to the blood filter 303. A second, optional flow pump 169 is provided, for example, downstream of the blood filter 303, which conveys dialysate to the outlet 153. A second valve can be provided between the blood filter 303 and the second flow pump 169, which opens or closes the outlet.

[0098] Furthermore, the treatment device 2000 optionally includes a device 161 for monitoring the flow in and out of the blood filter 303 on the machine side. The monitoring device 161 is preferably arranged in a line section between the first flow pump 159 and the second flow pump 169.

[0099] The treatment device 2000 also includes means for the exact removal of a fluid volume specified by the user and / or by the control device 150 from the balanced circuit, such as the ultrafiltration pump 131.

[0100] Sensors such as the optional conductivity sensors 163a, 163b are used to determine the conductivity, which in some embodiments is temperature compensated, as well as the fluid flow upstream and downstream of the blood filter 303.

[0101] Temperature sensors 165a, 165b can be provided individually or in groups. According to the invention, the temperature values ​​supplied by them can be used to determine a temperature-compensated conductivity.

[0102] Additional river pumps, either as a supplement or alternative to, for example, the one with reference number 169, may also be provided.

[0103] A range of optional valves is available in Fig. 1 Each is marked with a V. Bypass valves are marked with VB.

[0104] Based on the measured values ​​of the aforementioned optional sensors, in some embodiments the control device 150 determines the electrolyte and / or fluid balance.

[0105] Filters F1 and F2 can be connected in series.

[0106] The filter F1 serves here as an example to generate sufficient pure dialysis fluid using the mixing device 163, even with the use of impure water, which then flows through the blood filter 303, e.g. in a countercurrent flow.

[0107] Filter F2 serves as an example here to generate sterile or sufficiently filtered substitute from the sufficiently pure dialysis fluid leaving the first filter F1 by filtering out, for example, pyrogenic substances, which can then be safely supplied to the patient's extracorporeal blood flow and thus ultimately to the patient's body.

[0108] The treatment device 2000 is in Fig. 1 Although optionally shown as a device for hemo(dia)filtration, hemodialysis devices also fall within the scope of the present invention, even though they are not specifically illustrated in the figure.

[0109] A possible position of the short-circuit line 100 according to the invention within the treatment device 2000 can be seen. It becomes Fig. 2 described in more detail.

[0110] The present invention is not limited to the embodiment described above; this serves only for illustration.

[0111] The in Fig. 1 The arrowheads shown indicate Fig. 1 generally, the direction of flow is indicated.

[0112] Fig. 2 schematically simplified, it shows a section of the fluid piping structure of the Fig. 1 with a short-circuit line 100 according to the invention. Therefore, reference is made to the description of Fig. 1 Reference made to.

[0113] The short-circuit line 100 is designed or intended to be connected, after the end of a treatment session, with its first end by means of its connector 145' to the first connector 145 of the dialysis fluid inlet line 104 of the treatment device 2000 and with its second end by means of its connector 147' to the second connector of the dialysate outlet line 102 with the aim of establishing a fluid connection or short-circuiting the respective lines 102, 104.

[0114] By means of the dialysis fluid inlet line 104 of the treatment device 2000, dialysis fluid is directed out of the interior I of the treatment device 2000 and into an outer Ä of the treatment device 2000, or dialysis fluid is supplied from the treatment device 2000 to the blood filter 303.

[0115] By means of the dialysate drain line 102 of the treatment device 2000, dialysate is returned from the outer Ä to the inner I of the treatment device 2000 as intended, or dialysate from the blood filter 303 is fed back to the treatment device 2000.

[0116] Inner I and Outer Ä are in the Fig. 2 Separated by means of a dash-dotted line.

[0117] The short-circuit line 100 further comprises at least one backflow preventer 149, here by way of example a check valve, which permits flow through the short-circuit line 100 only, or essentially only, in the direction from its first connector 145' to its second connector 147', or hinders or prevents flow in the opposite direction. This prevents, after treatment and after the intended connection of both the dialysis fluid inlet line 104 to the short-circuit line 100 and the dialysate outlet line 102 to the short-circuit line 100, any flow of fluid from the dialysate outlet line 102 to the dialysis fluid inlet line 104 along and within the short-circuit line 100.In its intended use, this prevents a flow from the dialysate drain line 102 towards the dialysis fluid inlet line 104, or a fluidic connection from the connector of the dialysate drain line 147 towards the connector of the dialysis fluid inlet line 145, but not in the reverse direction.

[0118] If the connectors 145' and 147' are swapped during connection, i.e., if the first connector 145' of the short-circuit line 100 is accidentally connected to the connector of the dialysate drain line 147, and consequently the second connector 147' of the short-circuit line 100 is connected to the connector of the dialysis fluid inlet line 145, which corresponds to a state of the short-circuit line 100, fluid flow within the short-circuit line 100 from the second connector 147' to the first connector 145' would be prevented by the backflow preventer.

[0119] Since a faulty connection, such as incorrectly inserting the connectors (i.e., swapping the connectors when connecting the two lines 102 and 104 to the short-circuit line 100), prevents fluid flow through or along the short-circuit line 100, a pressure increase occurs in the dialysis fluid inlet line 104 when fluid is pumped along the dialysis fluid inlet line 104 towards the short-circuit line 100, for example, by the first flow pump 159. This pressure increase can be detected, for example, by the pressure sensor S03. The change in pressure between successive time points, such as the first and second time, can be determined and used as a pressure value. If the pressure value indicating the pressure change exceeds a first reference value, a faulty connection can be inferred.A corresponding signal can be sent.

[0120] In an alternative embodiment, fluid is pumped using the second flow pump 169 and / or the ultrafiltration pump 131, and the pressure in the dialysate drain line 102 is checked or monitored. If a sufficiently large pressure drop occurs in the dialysate drain line 102—for example, measured against a reference value—a faulty connection can be inferred, since the backflow preventer should open if the short-circuit line 100 is correctly connected to the connectors 145 and 147, which it clearly does not do given the pressure drop. A corresponding signal indicating a "faulty connection" can be output.

[0121] Similarly, a faulty connection can be detected by comparing the pressure in the dialysis fluid inlet line 104 with the pressure in the dialysate outlet line 102. If the pressure difference (as an example of a pressure value) between the pressure measured in the dialysis fluid inlet line 104 and the pressure measured in the dialysate outlet line 102 exceeds a predefined reference value, such as a second reference value, then a faulty connection can also be concluded.

[0122] By evaluating pressure values ​​based on pressures measured, for example, by the S03 pressure sensor or the S03 and PS4 pressure sensors, and by comparing them with one or more reference values, e.g., the first or second reference value, a faulty connection can be detected as a condition, stored, and / or displayed to a user.

[0123] For example, a disinfection program can be performed in the blood treatment device 2000 after a faulty connection is detected. This can be initiated by the control device 150, which can be programmed to automatically initiate such disinfection.

[0124] Additionally or alternatively, the condition of the short-circuit line 100, or the backflow preventer 149, can be detected to determine whether it is not functioning correctly or as intended – possibly despite a correct connection (see above) – but rather requires higher pressures to open than intended by the manufacturer. This also constitutes a condition. A procedure described below can be used to check for such a condition.

[0125] Fig. 3 The figure schematically illustrates the process of the method according to the invention in an exemplary embodiment. The reference numerals given refer to the descriptions of the Fig. 1 and 2 .

[0126] In this embodiment, the method according to the invention comprises, at a first point in time as M1, the step of measuring or otherwise determining a pressure prevailing within the dialysis fluid inlet line 104 and / or within the dialysate outlet line 102, hereinafter also referred to as the outlet pressure.

[0127] For example, it can be determined that before step M2, the pressures at the first pressure sensor S03 and at the second pressure sensor PS4 are the same or essentially the same.

[0128] Step M1 is optional.

[0129] M2 represents the step of actuating at least one pumping device, which is arranged here by way of example, for pumping fluid within the dialysate drain line 102, with the aim of building up pressure or vacuum against the backflow preventer of the bypass line 100. The actuating of the at least one pumping device preferably takes place when a first valve V24 is open, which is arranged here by way of example upstream of the first connector 145, but preferably downstream of the first pressure sensor S03, and preferably when a second valve V25 is open or closed, which is arranged, for example, downstream of the second connector 147, but preferably upstream of the second pressure sensor PS4.

[0130] At least one pumping device can be the ultrafiltration pump 131 and / or a second flow pump or charging pump 169.

[0131] Activating at least one conveying device can include building up a vacuum or pressure both upstream of the first connector 145 and downstream of the second connector 147. A negative pressure between 150 hPa and 400 hPa (-150 hPa to -400 hPa), preferably between 250 hPa and 350 hPa (-250 hPa to -350 hPa), and even more preferably between 300 hPa (-300 hPa), can be set. At the time when this negative pressure is established, the dialysis fluid inlet line 104 and the dialysate outlet line 102 are connected to the bypass line 100. By operating the pumping device downstream of the pressure sensor PS4, a negative pressure can thus be set in at least a portion of the dialysis fluid inlet line 104, the bypass line 100, and / or the dialysate outlet line 102.

[0132] The procedure comprises, as M3, the step of measuring or determining the pressure prevailing within the dialysis fluid inlet line 104 and / or within the dialysate outlet line 102, at a second time point in time which is later than the first time point in time.

[0133] After the second time point, a connection to the atmosphere can be established downstream of the second connector 147 and / or to the dialysate drain line 102.

[0134] After the negative pressure in the dialysate drain line 102 has been released, the pressure in the dialysis fluid inlet line 104 and in the dialysate drain line 102 is measured again at a third time point.

[0135] The negative pressure in the dialysate drain line 102 can be relieved by opening the dialysate drain line 102 to the environment. This can be achieved by opening the dialysate drain line 102 to the outlet 153 via a connection to a drain or discharge line. Alternatively, the negative pressure can be relieved by opening the dialysate drain line 102 to a fresh water branch. This connection can be made downstream or downstream of the water source 155 and upstream or downstream of the concentrate feed via a connection point not shown here.

[0136] During the adjustment and release of the negative pressure in the dialysate drain line 102, preferably no refilling of the dialysate inlet line 104 with dialysate takes place. This can be achieved, for example, by stopping the balancing device 161.

[0137] The measurement, at the first time point and / or at the second and / or at the third time point, of the pressure prevailing within the dialysis fluid inlet line 104 and / or within the dialysate outlet line 102 can be carried out by means of a first pressure sensor S03 arranged upstream of the first connector 145 and / or by means of a second pressure sensor PS4 arranged downstream of the second connector 147.

[0138] M4 represents the determination of a change in pressure within the dialysis fluid inlet line 104 and / or within the dialysate outlet line 102 based on the measured values ​​obtained at the first, second, and / or third time point by measuring the prevailing pressure. The determined change in pressure is used as a pressure value in the subsequent analysis.

[0139] M5 corresponds to the step of evaluating the determined change under predefined conditions. Such conditions can be, for example, limit values, thresholds, reference values ​​or ranges, or value ranges for the determined change, but also, for example, the duration until a predetermined change occurs, is recorded, etc.

[0140] If, at the third time point, that is, after the negative pressure in the dialysate drain line 102 has been released, it is determined that not only the negative pressure in the dialysate drain line 102 but also the negative pressure in the dialysis fluid inlet line 104 has been released, then a faulty condition or malfunction of the bypass line 100 can be inferred. A faulty condition of the bypass line 100 can be caused by a defect in the backflow preventer 149 of the bypass line 100, which is otherwise correctly connected to the dialysis fluid inlet line 104 and the dialysate drain line 102, or by the absence of the backflow preventer 149 (e.g., when using a bypass line without a backflow preventer).

[0141] The evaluation can be performed by measuring the pressure in the dialysis fluid inlet line 104 and / or in the dialysate outlet line 102 after the negative pressure has been released. If the non-return valve 149 is defective or missing, backflow from the dialysate outlet line 102 towards the dialysis fluid inlet line 104 can occur. Consequently, the pressure increases not only in the dialysate outlet line 102 but also, and possibly to the same extent, in the dialysis fluid inlet line 104.

[0142] As described above, pressure can be measured at three time points. Alternatively, the evaluation can also be based on a comparison of the pressure value in the dialysis fluid inlet line 104 at the second time point, i.e., after the build-up of negative pressure in the dialysate outlet line 102, and at the third time point, i.e., after the negative pressure in the dialysate outlet line 102 has been released. If a comparison of the pressures present in the dialysis fluid inlet line 104 at these time points shows, for example, with each other or with a preceding pressure, an exceedance of a limit value, i.e., an increase in the pressure in the dialysis fluid inlet line 104, then it can be concluded that fluid is flowing back from the dialysate outlet line 102 into the dialysis fluid inlet line 104. A faulty condition of the bypass line 100 therefore exists.

[0143] According to the invention, and particularly in this alternative embodiment, it is therefore sufficient to detect the pressure only in the dialysis fluid inlet line 104 and / or preferably only at a time after a negative pressure has been set in the dialysate outlet line 102 and at a time after the negative pressure in the dialysate outlet line 102 has been released.

[0144] In another alternative embodiment, the evaluation can be based on a comparison of the pressure in the dialysis fluid inlet line 104 after the negative pressure is released (after the third time point) with a pressure in the dialysate outlet line 102. If the pressure difference between these pressures, as a pressure value, is below a limit value, a faulty condition of the bypass line 100 can be inferred. Since no backflow occurs when the non-return valve 149 is functioning correctly, the negative pressure in the dialysis fluid inlet line 104 is maintained, while the negative pressure in the dialysate outlet line 102 is released, thereby establishing or maintaining a pressure difference between the dialysis fluid inlet line 104 and the dialysate outlet line 102.

[0145] In another alternative embodiment, after the third point in time, i.e., the release of the negative pressure in the dialysate drain line 102, this line is shut off downstream, so that there is no fluidic connection to the drain 153 or to the fresh water source 155. The pressure change is then determined as a pressure value in the dialysate drain line 102 by at least two pressure measurements. If a drop in pressure is observed in the dialysate drain line 102, a faulty condition of the bypass line 100 can also be inferred, since backflow occurs via the non-return valve 149 into the dialysis fluid inlet line 104, which is still under negative pressure. A corresponding signal can be output in each case.

[0146] Finally, M6 represents the optional step of outputting a corresponding signal, such as a message or an alarm, to the user of the treatment device 2000, indicating whether the change meets the predetermined conditions or not, that is, whether a faulty condition of the short-circuit line 100 has been detected or not. In some embodiments, this signal may also include instructions for the user, for example, that the hydraulics require disinfection before the next use.

[0147] In some embodiments, this signal can be supplied to the control device and, triggered by it, lead to disinfection, to blocking the use of the treatment device or certain operating modes before the next treatment, before the next cleaning or disinfection, or the like, etc. Bezugszeichenliste

[0148] 100 short-circuit line 2000 medical treatment device 2001 housing 101 Blood pump 102 Dialysate drain line 104 Dialysis fluid inlet line 105 Substitution line 107 Predilution valve 107a Line belonging to the predilution valve 109 Postdilution valve 109a Line belonging to the postdilution valve 111 Substitution pump 131 Ultrafiltration pump 145 Dialysis fluid inlet line connector 145' First connector of the bypass line 147 Dialysate drain line connector 147' Second connector of the bypass line 149 Non-return valve; check valve 150 Control device 153 Drain 155 Water source 157 Heat exchanger 159 First flow pump 161 Balancing device 162 Heating device 163 Mixing device 163a Conductivity sensor 163b Conductivity sensor 165a Temperature sensor 165b Temperature sensor 166 Concentrate supply 168 Concentrate supply 169 Second flow pump 171 Sodium pump 173 Bicarbonate pump 300 Extracorporeal blood circuit 301 First line (arterial line section) 302 (First) tubing clamp 303 Blood filter or dialyzer 303a Dialysis fluid chamber 303b Blood chamber 303c Semi-permeable membrane 305 Second line (venous line section) 306 (Second) tubing clamp 315 Detector 317 Single-needle chamber 318 Venting device 319 Detector 325 Heparin delivery point 329 Venous blood chamber (optional) F1Filter F2Filter AContainer BContainer Outer Interior M1 to M6 Procedure steps Pressure measuring points: PS1 Arterial pressure sensor (optional) PS2 Arterial pressure sensor (optional) PS3 Pressure sensor (optional) PS4 Second pressure sensor for measuring filtrate pressure (optional) S03 first pressure sensor Valves V24 Valve in dialysis fluid inlet line V25 Valve in dialysis outlet line VBBypass valves YY connectors

Claims

1. A method for checking a condition of a bypass line (100) connected to a dialysis liquid inlet line (104) and a dialysate outlet line (102) of a provided medical-technical treatment apparatus (2000), wherein the medical-technical treatment apparatus (2000) comprises: - the dialysis liquid inlet line (104) with a connector (145) provided for its connection to a blood filter (303); - the dialysate outlet line (102) with a connector (147) provided for its connection to a blood filter (303); and - a conveying device (159, 169, 131) for conveying fluid within the dialysis liquid inlet line (104) and / or within the dialysate outlet line (102); wherein the connected bypass line (100) comprises at least: - a first connector (145') for connecting the bypass line (100) to achieve fluid connection with the connector (145) of the dialysis liquid inlet line (104); - a second connector (147') for connecting the bypass line (100) to achieve fluid connection with the connector (147) of the dialysate outlet line (102); - a non-return valve (149) which allows the flow through the bypass line (100) only from the first connector (145') towards the second connector (147'), wherein the method comprises: - actuating the conveying device (159, 169, 131) with the aim of conveying fluid within the dialysis liquid inlet line (104) and / or within the dialysate outlet line (102) to establish positive pressure or negative pressure therein; - measuring a pressure prevailing in the dialysis liquid inlet line (104) and / or in the dialysate outlet line (102) at a first time point; - determining at least one pressure value based on the measured pressure; and - evaluating the at least one pressure value; and - emitting or outputting a signal indicating the condition of the bypass line (100) as a result of the evaluation, wherein: - the result is a faulty connection of the bypass line (100) with the dialysis liquid inlet line (104) and / or the dialysate outlet line (102), and / or - the result is a faulty function of the non-return valve (149) of the bypass line (100).

2. The method according to claim 1, - wherein evaluating of the at least one pressure value is or comprises a comparison of the at least one pressure value with a first reference value or reference range.

3. The method according to claim 1 or 2, wherein - the result that a faulty connection exists, is or presupposes a connection of the connector (145) of the dialysis liquid inlet line (104) to the second connector (147') of the bypass line (100) and a connection of the connector (147) of the dialysate outlet line (102) to the first connector (145') of the bypass line (100).

4. The method according to any one of claims 1 to 3, wherein, in order to determine the pressure value, both the pressure prevailing in the dialysis liquid inlet line (104) at the first time point, and the pressure prevailing in the dialysate outlet line (102) are or have been measured, wherein a pressure difference is determined between the pressure measured in the dialysis liquid inlet line (104) and the pressure measured in the dialysate outlet line (102), or vice versa; wherein evaluating the at least one pressure value is or comprises a comparison of this pressure difference with a second reference value or reference range therefor.

5. The method according to any one of claims 1 to 4, wherein the method further comprises: - measuring a pressure prevailing in the dialysis liquid inlet line (104) and / or in the dialysate outlet line (102) at a second time point and determining at least a second pressure value based thereon; wherein evaluating the pressure value is or comprises a comparison of the pressure difference between the pressure values determined in the dialysis liquid inlet line (104) at the first and second time points and / or a comparison of the pressure difference between the pressure values determined in the dialysate outlet line (102) at the first and second time points, with respectively a third or fourth reference value or range therefor.

6. The method according to any one of claims 1 to 5, wherein actuating the conveying device is carried out with the aim of establishing a negative pressure in the dialysis liquid inlet line (104) and in the dialysate outlet line (102); and wherein the method further comprises: - releasing the established negative pressure in the dialysate outlet line (102); wherein measuring a pressure prevailing in the dialysis liquid inlet line (104) and / or in the dialysate outlet line (102) comprises or consists of measuring at one or more time points after the pressure release.

7. The method according to any one of claims 1 to 6, wherein actuating the at least one conveying device takes place when a first valve (V24) is open, which is arranged upstream of the connector (145) of the dialysis liquid inlet line (104) but downstream of a first pressure sensor (S03), and / or when a second valve (V25) is open, which is arranged downstream of the second connector (147) of the dialysate outlet line (102) but upstream of a second pressure sensor (PS4).

8. The method according to any one of claims 6 to 7, wherein releasing the negative pressure in the dialysate outlet line (102) is preferably achieved by connecting the dialysate outlet line (102) to a fresh water source (155) or to a drain (153), more preferably by opening a valve to a fresh water line or a valve to a drain or discharge line, or comprises this.

9. The method according to any one of claims 6 to 8, wherein a signal, associated with a faulty condition of the bypass line (100), is emitted or output - if the evaluation of the pressure value indicates that it exceeds a reference value or leaves a reference range, and / or - if the determination of the pressure value, based on pressures measured after release within the dialysis liquid inlet line (104), indicates a pressure increase.

10. The method according to any one of claims 6 to 9, further comprising - fluidically shutting off the dialysate outlet line (102) after the negative pressure in the dialysate outlet line (102) has been released in such a way that there is no longer any connection between the dialysate outlet line (102) and the fresh water source (155) or the drain (153), wherein in order to determine the at least one pressure value, at least two pressures in the dialysate outlet line (102) are measured at two different time points after it has been shut off, and wherein a signal, associated with a faulty condition of the bypass line (100), is emitted or output, when, as a result of evaluating the at least one pressure value, a pressure change is detected within the dialysate outlet line (102).

11. A control device (150), programmed to carry out a test to check a condition of a bypass line (100) connected to the dialysis liquid inlet line (104) and the dialysate outlet line (102) of a medical-technical blood treatment apparatus (2000), the test comprising the steps of any one of the methods according to any one of claims 1 to 10.

12. A medical technical treatment apparatus (2000), - comprising a control device (150) according to claim 11.