SIGNAL-TRIGMED METHOD FOR EMPTYING AN EFFLUE BAG AND DEVICES

DE502020013129D1Active Publication Date: 2026-05-28FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH
View PDF 0 Cites 0 Cited by

Patent Information

Authority / Receiving Office
DE · DE
Patent Type
Patents
Current Assignee / Owner
FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH
Filing Date
2020-11-10
Publication Date
2026-05-28

AI Technical Summary

Technical Problem

Existing systems for emptying effluent bags during extracorporeal blood therapy are complex, require costly modifications to dialysis machines, and pose risks of electrical contact, while disrupting fluid balance and necessitating manual handling of heavy bags.

Method used

A control device integrated with a blood treatment device and an effluent bag emptying device, utilizing a pump section and a programmable system to automatically interrupt and restart fluid flows, and initiate effluent bag emptying at predetermined times, without requiring a power supply, thus ensuring seamless integration and safety.

Benefits of technology

The system allows for efficient, safe, and cost-effective effluent bag emptying that maintains fluid balance during therapy, reduces manual handling, and eliminates the need for costly machine modifications, optimizing workflow and reducing the risk of electrical accidents.

✦ Generated by Eureka AI based on patent content.
Patent Text Reader
Need to check novelty before this filing date? Find Prior Art

Description

[0001] The present invention relates to a control or regulating device according to claim 1, a treatment device according to claim 6, and an effluent bag emptying device according to claim 8. It further relates to a system according to claim 11. The disclosure also relates to a digital storage medium, a computer program product, a computer program, and furthermore to a method for emptying an effluent bag, according to the preambles or generic terms of these claims.

[0002] Extracorporeal blood therapy is a well-known procedure. In this process, blood is drawn from the patient and circulated extracorporeally, for example, through a blood filter. The blood filter has a blood chamber through which the blood flows and a dialysis fluid chamber through which the dialysis fluid flows. These two chambers are separated by a semipermeable membrane. Blood and dialysis fluid are usually passed through the blood filter in a countercurrent flow. The blood is purified in the blood filter, and the dialysis fluid, upon exiting the blood filter, is considered used and is discarded as dialysate. In addition to the dialysate, the discarded fluid also includes filtrate, which comprises water removed from the blood in the blood filter. The filtrate and dialysate are referred to individually or together, for simplicity, as effluent.

[0003] In practice, the effluent is either discarded immediately via an effluent drain line or, especially during acute treatment, placed in an effluent bag and stored therein. After completion of the blood treatment, or at bag-emptying intervals during the blood treatment (intervals in which the effluent bag is emptied), the effluent is discarded from the effluent bag, e.g., into a sink or other suitable drain. The relevant prior art is known from documents DE102017127394, CA3069257, US2011 / 036768, and EP2338542.

[0004] An object of the present invention may be seen as providing a control or regulating device, a blood treatment device and an effluent bag emptying device, furthermore a system consisting of or comprising the latter two devices.

[0005] Furthermore, a digital storage medium, a computer program product, and a computer program should be specified.

[0006] Furthermore, a method for emptying effluent bags should be specified that can be carried out with the above-mentioned system.

[0007] The problem according to the invention is solved by a control or regulating device with the features of claim 1, a treatment device with the features of claim 6, and an effluent bag emptying device with the features of claim 8. It is further solved by a system with the features of claim 11.

[0008] The invention is defined by the attached claims.

[0009] The present invention relates to a control device programmed to control a blood treatment device for treating a patient's blood. The treatment takes place during a treatment session, optionally using an extracorporeal blood tubing set and filling an effluent bag with effluent. During the treatment session, fluid flows (e.g., the flows of calcium solution, citrate solution, substitution solution (in predilution and / or postdilution), heparin solution, net ultrafiltration rate, dialysate flow rate, as applicable) are preferably monitored. These flows are generated by a calcium pump, a citrate pump, a substitution pump, a heparin pump, a filtrate pump, and / or a dialysis fluid pump of the blood treatment device.

[0010] The control device according to the invention is further programmed to be able to temporarily interrupt and restart the balancing, the flow by means of one or more, arbitrarily combinable, of the pumps used, in particular those mentioned above, e.g. the flow of the calcium solution (or the pumping activity of the calcium pump), the citrate solution (or the pumping activity of the citrate pump), the heparin solution (or the pumping activity of the heparin pump), the net ultrafiltrate flow (or the pumping activity of the filtration pump), the substitute flow (or the pumping activity of the substitute pump) and / or the dialysis fluid flow (or the pumping activity of the dialysis fluid pump) during the blood treatment session and / or within the duration of the blood treatment session.

[0011] The control or regulating device is specifically programmed to initiate such an interruption, preferably automatically, i.e. without human intervention, at one or more predetermined interruption times that occur during the treatment session, i.e. within the duration of the treatment.

[0012] The blood treatment device according to the invention comprises such a control or regulating device according to the invention.

[0013] The effluent bag emptying device according to the invention comprises an effluent drain line, which can be connected to an effluent bag via fluid flow and which could also be referred to herein as a spout, for conveying effluent from an effluent bag. The effluent bag emptying device also comprises a pump section for actively pumping effluent along the effluent drain line and thus out of the effluent bag.

[0014] A control device (which is optionally configured to also regulate) is also included in the effluent bag emptying device according to the invention. The control device is programmed to cause the pump section to pump effluent out of the effluent bag when (or as soon as) a predetermined emptying time occurs.

[0015] The system according to the invention comprises a blood treatment device according to the invention and an effluent bag emptying device according to the invention.

[0016] The digital storage medium is configured to interact with a programmable computer system in such a way that a control or regulating device of a blood treatment device is reprogrammed to a control or regulating device according to the invention, thereby making the blood treatment device a blood treatment device according to the invention, and / or that a control device of an effluent bag emptying device is programmed in such a way that the effluent bag emptying device becomes an effluent bag emptying device according to the invention.

[0017] The digital storage medium can be in the form of a floppy disk, CD or DVD, EPROM, FRAM or SSD, with electronically readable control signals.

[0018] The computer program product can be designed as a signal wave or with program code stored on a machine-readable carrier in order to interact with a programmable computer system in such a way that a control or regulating device is reprogrammed to a control or regulating device according to the invention and / or that a control device is reprogrammed to a control device of an effluent bag emptying device according to the invention.

[0019] The computer program comprises program code that causes or executes a control or regulating device to be reprogrammed to a control or regulating device according to the invention and / or that a control device is reprogrammed to a control device of an effluent bag emptying device according to the invention when the computer program runs on a computer.

[0020] The method for emptying an effluent bag, which was filled with effluent during a patient's blood treatment, takes place on a blood treatment device and an effluent bag emptying device according to the invention, or on a system according to the invention, wherein an effluent bag having an effluent outlet opening is provided on the blood treatment device or on the effluent bag emptying device.

[0021] The effluent outlet of the effluent bag is connected to the effluent drain line of the effluent bag emptying device to discharge effluent from the bag immediately or at a later time. If a shut-off valve is provided for the effluent outlet, opening the valve allows a fluid connection between the inside of the effluent bag and the inside of the effluent drain line. The method comprises stopping or interrupting the flow rate, the ultrafiltrate flow (or pumping activity) of the at least one filtrate pump, the substitute flow (or pumping activity) of the substitute pump, and / or the dialysis fluid flow (or pumping activity) of the dialysis fluid pump or one of the other pumps mentioned herein at (or from) one or more predetermined interruption times during the treatment session, i.e., within the treatment duration.

[0022] The process further includes initiating the pump section to pump effluent from the effluent bag when (or as soon as) a predetermined and / or defined emptying time occurs. The initiation of these two steps (stopping at the time of interruption and initiating pumping at the time of emptying) is optionally automatic, e.g., started by or triggered by the control device of the treatment device and / or by the control device of the effluent bag emptying device.

[0023] Inventory embodiments may include some, several, or all of the following features in any combination, provided that this is not technically impossible to the person skilled in the art. Advantageous further developments of the present invention are also the subject of the dependent claims.

[0024] 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.

[0025] 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.

[0026] When an embodiment is mentioned herein, it represents an exemplary embodiment according to the invention.

[0027] If it is disclosed herein that the object of the invention has one or more features in a particular embodiment, it is also disclosed herein that the object of the invention expressly does not have precisely this or these features in other embodiments, which are also according to the invention, e.g., in the sense of a disclaimer. For each embodiment mentioned herein, the opposite embodiment, formulated, for example, as a negation, is therefore also disclosed.

[0028] In some embodiments, the interruption is carried out by, or initiated by, the control or regulating device according to the invention, for a predetermined interruption duration (or: interruption interval), which begins each time at the onset of the interruption point. Successive interruption durations are preferably of constant length, but can alternatively be of different lengths.

[0029] In some embodiments, when the predetermined interruption time occurs, a notification or alarm may be issued to the user, prompting him to manually empty the effluent bag, for example a notification on the display and / or a visual and / or audible alarm (light source, lamp, speaker, etc.).

[0030] The effluent bag is in fluid communication with the blood treatment device during the blood treatment session and collects the effluent that accumulates during the treatment session. For this purpose, it can optionally be fluidically connected to the blood treatment device and / or the effluent bag emptying device. It can be held, carried, or picked up by the blood treatment device and / or the effluent bag emptying device.

[0031] In some embodiments, the control device according to the invention for the blood treatment device is connected to a signal transmitter or a clock, e.g., an internal clock (i.e., a clock of the control device). Alternatively, the clock can be an external clock, in particular a clock of the blood treatment device, a network clock, a station clock, or an atomic clock. The control device is configured to define or set the time of receiving a predetermined signal from the signal transmitter or the time of reaching the predetermined time as the interruption point (beginning of the interruption interval).

[0032] The control or regulating device, like the control device of the effluent bag emptying device described below, can be programmed to begin an interruption period (or interval) immediately upon a signal from the signal transmitter or at a predetermined time (e.g., measured at one of the clocks mentioned herein), or, in the case of the effluent bag emptying device, to begin an emptying period (or interval) after a predetermined duration or grace or waiting period has elapsed.

[0033] In some embodiments, the control or regulating device according to the invention is programmed to control or regulate the blood treatment device in such a way as to ensure that the effluent bag is not filled beyond a predetermined size or volume, in particular that it does not burst and cause contamination.

[0034] For example, the filling volume can be monitored using a scale, or the fill level of the effluent bag can be monitored using a sensor. If, for example, a predetermined weight or level is reached or exceeded, the control device, particularly automatically, can cause the blood balancing and / or at least one of the aforementioned pumps to be stopped and the effluent bag to be emptied automatically, e.g., by means of the effluent bag emptying device. The control device can also be programmed to initiate the subsequent continuation of the blood treatment session, the blood balancing, the pump operation, etc., e.g., also automatically.

[0035] The control device can optionally monitor and / or intervene to prevent the effluent bag from being filled beyond a predetermined level, for example, if an emptying interval has been skipped, which can also be initiated manually. In these embodiments, the detected level in the effluent bag and / or the detected weight of the bag can be used to initiate emptying. The blood treatment device can provide corresponding monitoring of the level and / or weight. If an operating condition occurs in which emptying via timing (i.e., considering the interruption points) is insufficient, and, for example, the scale or level sensor detects that the effluent bag is full or overfilled, an interruption interval can be automatically triggered.In this case, for example, the user may be prompted to manually start the emptying process.

[0036] Controlling, monitoring, or regulating may, for example, involve using data from pumps, scales, or sensors connected to the blood treatment device or the effluent bag emptying device to determine and / or monitor the fill level or weight of the effluent bag. Monitoring may include comparing the results with target values ​​and / or maximum values.

[0037] In some embodiments, the blood treatment device is designed as a hemodialysis device, hemofiltration device or hemodiafiltration device, in particular as a device for acute, chronic renal replacement therapy or for continuous renal replacement therapy (CRRT).

[0038] In some embodiments, the control device of the effluent bag emptying device according to the invention is programmed to pump effluent out of the effluent bag via the (or by means of the) effluent drain line by means of the pump section for a predetermined emptying time.

[0039] In some embodiments, the control device of the effluent bag emptying device is connected to a signal transmitter or a clock. The clock can be, in particular, a clock of the effluent bag emptying device itself, or it can be located within the effluent bag emptying device. The clock can be an external clock, in particular the optional clock of the blood treatment device, a network clock, a station clock, or an atomic clock. The control device is configured to define the time of receiving a predetermined signal from the signal transmitter or upon reaching a predetermined time on the clock (or, if applicable, after receiving a corresponding signal from the clock) as the emptying time, or to set it depending on this, e.g., in a time-dependent manner.

[0040] In some embodiments of the system according to the invention, the blood treatment device and the effluent bag emptying device are separate from each other, particularly during the treatment of the patient, which is carried out by means of the blood treatment device and / or during the emptying of the effluent bag, without a fluid connection between the effluent bag and the blood treatment device and / or between the effluent bag and the effluent bag emptying device.

[0041] In some embodiments of the system, the control or regulating device of the blood treatment device and the control device of the effluent bag emptying device are each programmed such that at least one interruption time and at least one emptying time occur simultaneously or offset from each other by a predetermined duration or grace period, and in particular are in a predetermined temporal relationship with each other.

[0042] The system can be configured such that the interruption intervals of the blood treatment device are related to the emptying intervals of the effluent bag emptying device, e.g., by a temporal relationship, in order to trigger the emptying of an effluent bag, i.e., an emptying interval, of the effluent bag emptying device precisely when an interruption interval is present at the blood treatment device.

[0043] In some embodiments of the system, the control or regulating device of the blood treatment device and the control device of the effluent bag emptying device are each programmed such that at least one interruption duration (or interruption interval) and one emptying duration (or emptying interval) overlap, in particular by at least 50%, 60%, 70%, 80% or 90% of the duration of one of the two.

[0044] In some embodiments of the system, the clock with which the control or regulating device of the blood treatment device is in signal communication and the clock with which the control device of the effluent bag emptying device is in signal communication are identical or synchronized; that is, they are either one and the same clock or two clocks that display, indicate, or output the same time or at least comparable times. Alternatively, the system may know the generally constant deviation between the two times. In particular, the two clocks are oriented to the same time zone (e.g., Central European Time (CET)).

[0045] In some embodiments, the predetermined interruption time and / or the predetermined emptying time each occur at a predetermined time, e.g., on the hour (for example, 3:00 p.m., 4:00 p.m., etc.), every half hour (for example, 3:00 p.m., 3:30 p.m., 4:00 p.m., 4:30 p.m., etc.), etc.

[0046] In some embodiments, the predetermined interruption or emptying time occurs a predetermined number of time units (e.g., minutes, half hours, quarter hours, or fractions thereof) after a defined event. For example, any given time can be fixed or variable and predetermined by the manufacturer or user, such as 30 minutes after the start of the treatment session, after pressing the start button, after the initial start or stop of the balancing system, the ultrafiltration pump, or another pump, or after a first, second, or third interruption or emptying time preceding this interruption or emptying time. usw. lay.

[0047] In some embodiments, an interruption duration (or an interruption interval) begins at an interruption time and / or an emptying duration (or an emptying interval) begins at an emptying time.

[0048] In some embodiments, the pump section of the effluent bag emptying device according to the invention is disposable, a throwaway or single-use item.

[0049] In some embodiments, the pump section includes an impeller or pump rotor.

[0050] In some designs, the effluent drain line is connected to the pump section.

[0051] In some embodiments, the pump section is connected to, or can be connected to, an optionally detachable pump drive.

[0052] In some embodiments, the pump section or pump drive has a rechargeable power source, e.g. a battery.

[0053] In some embodiments of the method according to the invention, the effluent is pumped out of the effluent bag by means of the pump section.

[0054] In some embodiments of the method, the opening of the shut-off element is done manually, in others automatically.

[0055] In some embodiments, the effluent bag can be a container of any kind, for example a container with a flexible outer skin such as a film, or made of film, have a hard outer skin such as a canister, etc.

[0056] Suitable, optional hose connectors or connector pairs may be provided to facilitate connecting the effluent drain line to the effluent bag and / or to the spout.

[0057] In some embodiments, the pump section is magnetically mounted or driven and includes, in particular, the pump head. This pump head is, for example, designed as an impeller pump head or its rotor. This electrically insulated type of mounting or drive serves to protect the patient from electric shock.

[0058] In some embodiments, the pump drive is manually connected to the pump section, which includes the pump head.

[0059] In some embodiments, the pump drive is optionally equipped with a magnetic section, e.g., designed as coils with an iron core. This serves for the magnetic coupling and / or magnetic driving of components, in particular a magnetically driven pump rotor. The drive is preferably contactless.

[0060] In some embodiments, an induction charging station for charging the pump drive's battery is included. The induction charging station optionally has control electronics configured to detect when the pump drive is placed on the charging station and to charge the battery.

[0061] The induction charging station can be or have a platform or mounting level for the pump drive.

[0062] The present invention relates to an effluent bag emptying device comprising at least one pump section with a pump rotor. The pump section is designed to be functionally connected or brought together with a pump drive. In some embodiments, the pump section, and optionally all other sections of the effluent bag emptying device, lack any means for connecting the pump section to the pump drive, apart from an optional magnetic connection and / or the use of gravity.

[0063] In some embodiments, the pump drive has an induction charging coil for charging the voltage source or battery.

[0064] In some embodiments, the housing of the pump drive has a pump drive mounting section for mounting the pump drive on a pump drive mounting surface.

[0065] In some embodiments, the pump drive housing has a connecting section for, in particular functionally, connecting the pump drive to the pump section, which contains a pump rotor. This connecting section can be a cavity, one or more openings, one or more blind openings, or the like.

[0066] In some embodiments, the pump drive mounting section and the connecting section are located at opposite ends of the pump drive housing or are associated with it.

[0067] In some embodiments, the pump drive has at least one lighting device, in particular a colored one. This can be designed in particular as a ring, especially as an LED or LED color ring.

[0068] The lighting device can be positioned in or on the housing of the pump drive.

[0069] In some embodiments, the control electronics of the pump drive are equipped with or connected to a wireless module.

[0070] In some embodiments, the control electronics are designed with or connected to at least one motion sensor.

[0071] In some embodiments, the control electronics are configured to switch off the lighting device when or after the voltage source or battery has reached a state of full charge.

[0072] In some embodiments, the preferred electrical power rating is between 25 and 40 watts (W), in particular 30 to 35 W, and most particularly 32 W.

[0073] In some embodiments, the operating voltage of the electric drive of the pump is 24 V.

[0074] In some embodiments, the pump section has a device for detachably attaching it to a section of the effluent bag emptying device, in particular for detachably attaching it to a mounting section of the effluent bag emptying device or to the base of the blood treatment device.

[0075] In some embodiments, the device for releasably fastening the pump section is a clamping device or a latching or clipping device, or includes one.

[0076] In some embodiments, the device for releasably fastening the pump section, which is optionally a clamping device or a snap-fit ​​or clip device, has a curved shape.

[0077] The curved path can have the shape of a half-channel curved along its longitudinal extent.

[0078] In some embodiments, the pump drive, the pump section and / or another component of the pump does not have any mechanical connecting device for connecting the pump drive to the pump section, except for the mounting surface of the pump section on which the pump drive is placed to achieve a functioning pump.

[0079] One advantage of this design is that the pump drive can be easily pulled or lifted off at any time (even during pumping). This can be done with one hand, especially since no mechanical connections need to be opened beforehand, as these are not included in these designs.

[0080] In some embodiments, the pump section with its liquid inlet or fluid inlet is connected to a hose section that leads from the effluent bag to the pump.

[0081] In some embodiments, the pump section with its liquid outlet or fluid outlet is connected to the drain line, which may lead to a drain, sink or spout for discarding the effluent.

[0082] In some embodiments, the pump rotor is magnetically mounted and / or magnetically driven.

[0083] The magnetic section of the pump rotor can be a permanent magnet.

[0084] In some embodiments, the storage capacity of the pump drive battery is between 800 mAh and 1800 mAh, preferably between 1000 mAh and 1500 mAh, and most preferably approximately or exactly 1100 mAh.

[0085] In some embodiments, the fluid inlet of the pump section is connected to the effluent bag via a hose or pipe during the treatment session. In other embodiments, the fluid inlet of the pump section is separate from the effluent bag during the treatment session.

[0086] In some embodiments, the effluent drain line has at least one check valve, e.g., upstream of the pump drive. When the effluent bag is disconnected, the check valve can advantageously prevent unintentional leakage of effluent from the drain line, thus improving cleanliness and hygiene.

[0087] In some embodiments, the effluent drain line, which connects downstream of the effluent bag, has no element upstream and / or downstream of the pump section of the effluent bag emptying device that would be connected to an electrical control device, such as an electrically connected connector. The pump or pump section is optionally excluded from this; it may be electrically connected. However, it is also optionally not electrically connected to, for example, a control device.

[0088] In some embodiments, the pump is configured, for example as an impeller pump, such that it can empty an effluent bag filled with ten liters of effluent in about five minutes or less, preferably in about two minutes, at least at maximum high flow rate.

[0089] In some embodiments, the effluent bag emptying device according to the invention comprises a bag holder for holding or receiving an effluent bag with an effluent outlet opening. Optionally, the effluent bag or the effluent bag emptying device includes a shut-off element for temporarily closing the effluent outlet opening.

[0090] In some embodiments, the interruption is carried out by, or caused by, the control or regulating device according to the invention, while the effluent bag is still attached, and preferably while it is not yet being pumped empty.

[0091] Some or all embodiments of the invention may have one, several or all of the advantages mentioned above and / or below.

[0092] An advantage of the present invention is that the emptying of the effluent bag can be integrated into the course of extracorporeal blood therapy in such a way that the fluid balance during the blood treatment is not disrupted or distorted. Furthermore, it is advantageous that no devices are required to ensure continuous and reliable fluid balance monitoring during the emptying of the effluent bag, with the aim of maintaining an accurate fluid balance.

[0093] A further advantage is that, thanks to the effluent bag emptying device according to the invention, clinical staff no longer need to carry the bag to a drain, such as a sink, toilet, or sewer. Since full effluent bags typically weigh around 10 kg, this task is significantly relieved for clinical staff if the mobile, separately usable effluent bag emptying device is placed, for example, directly next to the blood treatment device, allowing the bag to remain attached to the device during the emptying process.

[0094] Conventional systems and devices for emptying the effluent bag are sometimes very complex and, in some cases, require approval as medical devices. Some of these systems, for example, require sophisticated hardware on the dialysis machine, particularly specialized weighing or weighing systems. Retrofitting such systems to facilitate effluent bag emptying requires modifications to the dialysis machine's hardware, which can be time-consuming and expensive due to the need for re-certification of the modified machine. For this reason, retrofitting existing dialysis machines is often not feasible.The present invention provides a cost-effective and simple system for emptying effluent bags that does not require approval as a medical device and can also eliminate the need for re-approval of the blood treatment device whose effluent bag is to be emptied. Rather, existing blood treatment devices can be easily supplemented by positioning the effluent bag emptying device according to the invention near the blood treatment device and using it to empty the effluent bag. The control device of the blood treatment device only needs to be programmed to respond to occasional interruptions, e.g., during blood volume monitoring, or to transmit information about when such interruptions occur, or such interruptions must be communicated to the effluent bag emptying device via a signal.Effluent bags already known from the market can advantageously continue to be used together with the devices according to the invention.

[0095] The present invention advantageously avoids the risk of electrical contact occurring between the liquid in the effluent drain line or another effluent-carrying line and ground during drainage of the effluent bag, which would cause permissible patient leakage currents to be exceeded in the event of a malfunction, since the effluent bag emptying device according to the invention does not itself require a power supply. The use of the battery-operated pump poses no risk of electrical accident or voltage damage to the patient.

[0096] A further advantage of the present invention may be that, through the regular to quasi-continuous emptying of the effluent bag, previously required bag change intervals for the effluent bag, or intervals to empty it, can be at least partially eliminated.

[0097] A further advantage of the present invention may be that its use can optimize workflows on the blood treatment device, since emptying the full effluent bag can, for example, take place during interruptions of the treatment flows that would occur anyway.

[0098] All the advantages achievable with the method according to the invention can also be achieved without diminishing the benefits of the devices according to the invention, and vice versa.

[0099] The present invention is described below by way of example only, with reference to the accompanying drawing. In the drawing, the same reference numerals denote identical or identical components. The following applies to the figures in the drawings: Fig. 1 shows in simplified form a process flow diagram of a blood treatment device according to the invention with an extracorporeal blood circulation and a control or regulating device according to the invention; Fig. 2 shows an effluent bag emptying device according to the invention in a first embodiment; and Fig. 3 Figure 1 shows a highly simplified diagram of a volume flow in an effluent inlet line of a blood treatment device according to the invention over time (top) and a diagram of the volume flow in the effluent outlet line of an effluent bag emptying device according to the invention over time (bottom).

[0100] Fig. 1 Figure 1 shows a highly simplified process flow diagram of a blood treatment device 100 according to the invention, optionally connected to an extracorporeal blood circuit 300 and a drainage tube system leading to an effluent bag 400. The effluent bag 400 can be part of the blood treatment device 100 or part of the [unclear text]. Fig. 2 The effluent bag emptying device shown is 4000.

[0101] The extracorporeal blood circulation 300 has a first conduit 301, here in the form of an arterial conduit section.

[0102] The first line 301 is in fluid connection with a blood treatment device, here by way of example a blood filter or dialyzer 303. The blood filter 303 has a dialyzing fluid chamber 303a and a blood chamber 303b, which are separated from each other by a mostly semi-permeable membrane 303c.

[0103] The extracorporeal blood circulation 300 also includes at least one second line 305, here in the form of a venous line segment. Both the first line 301 and the second line 305 can serve to connect to the vascular system of the patient (not shown).

[0104] The first line 301 is optionally connected to a (first) hose clamp 302 for locking or closing the line 301. The second line 305 is optionally connected to a (second) hose clamp 306 for locking or closing the line 305.

[0105] The in Fig. 1 The blood treatment device 100, represented only by some of its features and schematically, includes a blood pump 101. During the treatment of the patient, the blood pump 101 pumps blood through sections of the extracorporeal blood circulation 300 and towards the blood filter or dialyzer 303, as shown by the small arrowheads which generally indicate the direction of flow in each of the figures.

[0106] Fresh dialysate is pumped from a source 200 along the dialysate inlet line 104 into the dialysate chamber 303a by means of a dialysate pump 121, which can be designed as a roller pump or as an otherwise occluding pump. The dialysate leaves the dialysate chamber 303a as dialysate, optionally enriched with filtrate, towards the effluent bag 400 and is referred to therein as effluent.

[0107] Source 200 can be, for example, a bag or a container. Source 200 can also be a fluid line from which online and / or continuously generated or mixed fluid is supplied, e.g., a hydraulic outlet or port of the blood treatment device 100.

[0108] An additional source 201 with a substitute may be provided optionally. It may correspond to source 200 or be a separate source.

[0109] A merely indicated control or regulating device 150 can be configured to regulate or control the blood treatment session.

[0110] The control or regulating device 150 can be provided to cause a pause in the blood treatment device 100's balancing process by means of a merely indicated clock 160, optionally by means of a signal transmitter 170, e.g. at predetermined times or after predetermined time intervals.

[0111] Alternatively, the clock 160 can be designed to be in signal communication with, synchronized with, or identical to an external clock 5000, for example a network clock, a station clock or an atomic clock.

[0112] The clock 160 and / or the signal transmitter 170 can optionally be further configured to work with a clock of the effluent bag emptying device 4000, as described above. Fig. 2 described as being in signal contact, e.g. in order to be synchronized with it.

[0113] Alternatively or additionally, the signal transmitter 170 can be in signal connection with the control device 450 of the effluent bag emptying device 4000 in order to cause it to initiate or trigger an emptying interval by means of the pump section 2300 (see Fig. 2 ).

[0114] The bottom right corner is in Fig. 1 It is indicated where the effluent bag 400 is optionally connected to the blood treatment device 100 via a fluidic, form-fitting, and / or force-fitting connection. An effluent bag emptying device 4000, optionally connected to the effluent bag 400 only fluidically, and its components are only shown in Fig. 2 shown.

[0115] In addition to the aforementioned blood pump 101, the one in Fig. 1 The arrangement shown also optionally includes a number of further, each optional, pumps, namely pump 111 for substitute, pump 121 for dialysis fluid and pump 131 for the effluent.

[0116] The pump 121 is designed to draw dialysis fluid from a source 200, for example a bag, and supply it to the blood filter 303 via the dialysis fluid inlet line 104 using an optional bag heater H2 and a heating bag.

[0117] The dialysate supplied in this way exits the blood filter 303 via a dialysate drain line 102, supported by the optional pump 131, and can be discarded.

[0118] An optional arterial sensor PS1 is provided for the power supply of the blood pump 101. During patient treatment, it measures the pressure in the arterial line.

[0119] Downstream of blood pump 101, but upstream of blood filter 303 and, if provided, upstream of a heparin injection point 25, an additional, optional pressure sensor PS2 is provided. It measures the pressure upstream of blood filter 303 ("pre-hemofilter").

[0120] A further pressure sensor can be provided as PS4 downstream of the blood filter 303, but preferably upstream of the pump 131, in the dialysate drain line 102 to measure the filtrate pressure of the blood filter 303.

[0121] Blood leaving the blood filter 303 flows through an optional venous blood chamber 29, which may have a venting device 31 and / or an additional pressure sensor PS3.

[0122] The in Fig. 1 The control or regulating device 150 shown can be connected to any of the components mentioned herein - in any case or in particular to the blood pump 101 - by wired or wireless signal connection for the control or regulation of the blood treatment device 100.

[0123] The optional pump 111 is designed to draw substitute from the optional source 201, for example a bag, and supply it to the second line 305 via an optional bag heater H1 and a heated bag.

[0124] Fig. 2 Figure 4000 shows an effluent bag emptying device according to the invention in a first embodiment.

[0125] The Fig. 2 Furthermore, on the left side, it shows a section of the extracorporeal blood circulation 300 of a blood treatment device 100. Fig. 1 , namely arterial line section 301, which, with regard to the Fig. 2 , from below into the blood chamber 303b of the dialyzer 303. On the opposite side of the dialyzer 303 (in the Fig. 2 The venous line section 305 leads out of the blood chamber 303b (above). Separated from the blood chamber 303b by the semi-permeable membrane 303c lies the dialysis fluid chamber 303a, into which fresh dialysis fluid enters the dialyzer 303 via the dialysis fluid inlet line 104. Downstream of the dialyzer 303, the dialysis fluid, henceforth referred to as filtrate or effluent, is pumped by the pump 131 through the dialysis outlet line or effluent inlet line 102 (since it supplies effluent to the effluent bag 400) from the dialysis fluid chamber 303a towards the effluent bag 400 and there through an effluent inlet opening 400a into the interior of the effluent bag 400. The effluent bag 400 is shown here as an example arranged on or in a bag holder 430, which in turn is equipped with a scale W1 orconnected to another weighing device and may be part of the blood treatment device 100 or the effluent bag emptying device 4000.

[0126] An exemplary fill level or liquid level inside the Effluent Bag 400 is marked with a dot-dash line.

[0127] During an interruption interval, in which the blood processing unit 100 and thus, for example, the pump 131 are stopped, the pump section 2300 is activated by means of a control device 450. It then draws the effluent contained in the effluent bag 400, or parts thereof, through the effluent outlet opening 400b, which is located in Fig. 2 optionally located at the bottom right of the effluent bag 400, it pumps effluent along an effluent drain line 403, e.g. into a sink 6000.

[0128] To determine the start of pumping, i.e., to determine when emptying has occurred, a clock 460 can be installed in the effluent bag emptying device 4000. The effluent bag emptying device 4000 can optionally be connected to the clock 160 of the blood treatment device 100, the signal transmitter 170, or an external clock 5000 (see Fig. 1 ) are in signal communication.

[0129] The control device 450 of the effluent bag emptying device 4000 can be programmed to start the emptying process at a predetermined time and for a specific period of predetermined duration, the emptying period, and preferably also to end it when the end of this period is reached. If possible, this emptying period preferably falls within or overlaps with an interruption interval during which the blood treatment device 100 is stationary (interruption duration). Preferably, the effluent bag 4000 is completely emptied during this emptying period (see also Fig. 3 ).

[0130] In this embodiment, the term "the blood treatment device 100 is stationary" means that at this time at least one of the pumps 111, 121 and 101 (see Fig. 1 ) does not promote and / or the accounting is suspended.

[0131] As in Fig. 2 As indicated herein, any two or more of the components of the effluent bag emptying device 4000 mentioned herein may optionally be located wholly or partially in or on a common housing 4001.

[0132] Fig. 1 and Fig. 2 They jointly show a possible embodiment of the system according to the invention.

[0133] Fig. 3 The diagram above shows an exemplary volume flow rate Q generated by pump 131 in the effluent inlet line 102 over time t.

[0134] Using pump 131, a volume V1 is pumped into the effluent bag 400 from time t=0 to time t=t1, and a volume V2 is pumped in from time t=t1 to time t=t2. These volumes V1 and V2 are shown in the upper diagram of the Fig. 3 Each is shown hatched.

[0135] The diagram above further shows that pump 131 is stopped at predetermined times t1 and t2, and each time for the predetermined length or duration of an interval I1 or I2 (interruption intervals are denoted by I). interruption (designated) does not promote.

[0136] I1 and I2 are to be understood here as interruption durations, and t1 and t2 as interruption times at which I1 and I2 each begin.

[0137] Fig. 3 The diagram below shows a volume flow rate Q out with which the pump section 2300 of the effluent drain line 403 of the effluent bag emptying device 4000 pumps effluent out of the effluent bag 400 over time t.

[0138] The diagram below shows that the pump section 2300 is activated at predetermined times t3 and t4 and pumps O3 and O4 respectively for the length of a predetermined interval (emptying intervals are denoted here by O as out).

[0139] O3 and O4 are to be understood here as emptying time durations, and t3 and t4 as emptying times at which O3 and O4 respectively begin.

[0140] The lower diagram further shows that the third time point t3 can be delayed by an optional grace period after the first time point t1, and the fourth time point t4 can be delayed by an optional grace period after the second time point t2 (see the upper diagram for t1 and t2, respectively). These time delays can be of equal length, but they do not have to be. Furthermore, the intervals O3 and O4 preferably lie within or overlap with the intervals I1 and I2.

[0141] Preferably, within intervals O3 and O4, the same volumes V1 and V2 are pumped out of the effluent bag 400 by means of pump section 2300 as were previously pumped into the effluent bag 400 by means of pump 131 before intervals I1 and I2 (in the upper diagram). These volumes V1 and V2 are also shown hatched in the lower diagram. Bezugszeichenliste

[0142] 25 Heparin injection site (optional) 29 Venous blood chamber (optional) 31 Venting device 100 Blood treatment device 101 Blood pump 102 Dialysate drain line, effluent inlet line 104 Dialysis fluid inlet line 111 Substitute pump 121 Dialysis fluid pump 131 Dialysate or effluent pump in effluent inlet line 150 Control device 160 Clock 170 Signal transmitter 200 Dialysis fluid source 201 Substitute source, optional 300 Extracorporeal blood circulation 301 First line (arterial line) 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) 306 (Second) tubing clamp 400 Effluent bag; 400a Effluent inlet; 400b Effluent outlet; 403 Effluent drain pipe, spout pipe 430Bag holder 450Control device 460Clock 2300 Pump section 4000 Effluent bag emptying device 4001 Housing 5000 Clock 6000 Spout; Drain; Outlet H1 Bag heater with bag (substitute) H2 Bag heater with bag (dialysis fluid) I1, I2 Time interval; Interruption interval O3, O4 Time interval; Emptying interval PS1, PS2 Arterial pressure sensor (optional) PS3 Pressure sensor (optional) PS4 Pressure sensor for measuring filtrate pressure t1 first time point; interruption time t2 second time point; interruption time t3 third time point; emptying time t4 fourth time point; emptying time V1 first funding volume V2 second funding volume W1 scale

Claims

1. A control or regulating device (150) programmed to control or regulate a blood treatment apparatus (100) during a treatment session treating a patient's blood carried out by means of an extracorporeal blood tubing set (300) and the blood treatment apparatus (100), whilst balancing liquid flows, conveying using a filtrate pump (131), conveying using a substitute pump (111) and / or conveying using a dialysis liquid pump (121), characterized in that the control or regulating device (150) is further programmed to: - interrupt the balancing, and / or - interrupt the calcium solution flow or the conveying action of the calcium pump, the citrate solution flow or the conveying action of the citrate pump, the heparin solution flow or the conveying action of the heparin pump, the filtrate flow or the conveying action of the filtrate pump (131), the substitute flow or conveying action of the substitute pump (111) and / or the dialysis liquid flow or the conveying action of the dialysis liquid pump (121), at one or more predetermined interruption time points (t1, t2) which fall within the duration of the treatment session.

2. The control or regulating device (150) according to claim 1, wherein the interruption takes place in each case for a predetermined interruption period (I1, I2), beginning with the corresponding interruption time point (t1, t2).

3. The control or regulating device (150) according to claim 1 or claim 2, wherein, upon reaching the predetermined interruption time point (t1, t2), a notification or alarm may be issued to the user, prompting him to manually empty an effluent bag (400) which is in fluid communication with the blood treatment apparatus (100) during the blood treatment session in order to receive effluent generated during the treatment session.

4. The control or regulating device (150) according to any one of the preceding claims, being in signal communication with a signal emitter (170) or with a clock of the control or regulating device (150) or an external clock (5000), in particular a clock (160) of the blood treatment apparatus (100), a network clock, a ward clock or an atomic clock, and wherein the control or regulating device (150) is configured, to define as the interruption time point (t1, t2) the time of receiving the signal or reaching the predetermined time when a predetermined signal is received from the signal emitter (170) or when a predetermined time is reached on the clock (160, 5000).

5. The control or regulating device (150) according to any one of the preceding claims, which is programmed to monitor that the effluent bag (400) is not filled beyond a predetermined level or volume.

6. A blood treatment apparatus (100) comprising a control or regulating device (150) according to any one of claims 1 to 5.

7. The blood treatment apparatus (100) according to claim 6, embodied as a dialysis apparatus, hemodialysis apparatus, hemofiltration apparatus or hemodiafiltration apparatus, in particular as an apparatus for chronic renal replacement therapy or for continuous renal replacement therapy (CRRT).

8. An effluent bag draining apparatus (4000), comprising: - an effluent outlet line (403) for guiding effluent out of an effluent bag (400); - a pump section (2300) for conveying effluent out of the effluent bag (400); characterized by a control device (450), programmed to ensure that the pump section (2300) conveys effluent out of the effluent bag (400) when a predetermined draining time point (t3, t4) is reached.

9. The effluent bag draining apparatus (4000) according to claim 8, wherein the control device (450) is programmed to convey effluent out of the effluent bag (400) via the effluent outlet line (403) using the pump section (2300) during a predetermined draining time period (O3, O4).

10. The effluent bag draining apparatus (4000) according to claim 8 or claim 9, wherein the control device (450) is in signal communication with a signal emitter (170) or a clock, in particular a clock (160) of the blood treatment apparatus (100), a clock (460) of the effluent bag draining apparatus (4000), or an external clock (5000), in particular a network clock, a ward clock or an atomic clock, and wherein the control device (450) is configured to define or set, in relation to this, as the draining time point (t3, t4), the time of receiving the signal or reaching the predetermined time when a predetermined signal from the signal emitter (170) is received or when a predetermined time on the clock is reached.

11. A system comprising a blood treatment apparatus (100) according to any one of claims 6 to 7 and an effluent bag draining apparatus (4000) according to any one of claims 8 to 10.

12. The system according to claim 11, wherein the blood treatment apparatus (100) and the effluent bag draining apparatus (4000) are separate from each other.

13. The system according to claim 11 or 12, wherein the control or regulating device (150) of the blood treatment apparatus (100) and the control device (450) of the effluent bag draining apparatus (4000) are each programmed such that at least one interruption time point (t1, t2) and at least one draining time point (t3, t4) occur simultaneously or offset from each other by a predetermined period of time.

14. The system according to any one of claims 11 to 13, wherein the control or regulating device (150) of the blood treatment apparatus (100) and the control device (450) of the effluent bag draining apparatus(4000) are each programmed such that at least one interruption period (I1, I2) and one draining time period (O3, O4) overlap each other, in particular by at least 50%, 60%, 70%, 80% or 90% of the duration of either of them.

15. The system according to any one of claims 11 to 14, wherein the signal emitter (170) or the clock, with which the control or regulating device (150) of the blood treatment apparatus (100) is in signal communication, and the signal emitter (170) or the clock, with which the control device (450) of the effluent bag draining apparatus (4000) is in signal communication, are identical or synchronized.