Signal Activated Method for Draining an Effluent Bag and Devices

20220395618 · 2022-12-15

    Inventors

    Cpc classification

    International classification

    Abstract

    The present disclosure relates to a control device or closed-loop control device, programmed to control or regulate a blood treatment apparatus during a treatment of a patient's blood carried out in a treatment session using an extracorporeal blood tubing set and the blood treatment apparatus while balancing liquid flows and conveying via different liquid pumps. The control device or closed-loop control device is further programmed to interrupt the balancing and/or the liquid flows at one or more predetermined interruption time points which lie within the duration of the treatment session.

    Claims

    1-19. (canceled)

    20. A control device or closed-loop control device programmed for controlling or regulating a blood treatment apparatus during a treatment session that treats a patient's blood and that is carried out by an extracorporeal blood tubing set, wherein the blood treatment apparatus, while balancing liquid flows, conveying using a filtrate pump, conveying using a substituate pump, and/or conveying, using a dialysis liquid pump, wherein the control device or closed-loop control device is further programmed to, at one or more predetermined interruption time points that fall within the duration of the treatment session: interrupt a balancing of the liquid flows, and/or interrupt a calcium solution flow or a conveying action of a calcium pump, a citrate solution flow or a conveying action of a citrate pump, a Heparin solution flow or a conveying action of a Heparin pump, a filtrate flow or a conveying action of the filtrate pump, a substituate flow or a conveying action of a substituate pump, and/or a dialysis fluid flow or a conveying action of a dialysis liquid pump.

    21. The control device or closed-loop control device according to claim 20, wherein an interruption takes place for a predetermined interruption period beginning with a corresponding interruption time point.

    22. The control device or closed-loop control device according to claim 20, wherein upon reaching the predetermined interruption time point, a signal or alarm may be given to the user prompting the user to manually empty an effluent bag that is in fluid communication with the blood treatment apparatus during the blood treatment session in order to receive effluent that is produced during the treatment session.

    23. The control device or closed-loop control device according to claim 20, wherein the control device or closed-loop control device is in signal communication with a signal emitter or with a clock of the control device or closed-loop control device or an external clock of the blood treatment apparatus, a network clock, a ward clock or an atomic clock, and wherein the control device or closed-loop control device is configured, upon receiving a predetermined signal from the signal emitter or upon reaching a predetermined time on the clock, to specify a time that the predetermined signal is received or the predetermined time is reached as an interruption time point.

    24. The control device or closed-loop control device according to claim 20, wherein the control device or closed-loop control device is programmed to monitor the effluent bag to ensure that the effluent bag is not filled above a predetermined level or volume.

    25. A blood treatment apparatus having a control device or closed-loop control device programmed for controlling or regulating the blood treatment apparatus during a treatment session that treats a patient's blood and that is carried out by an extracorporeal blood tubing set, wherein the blood treatment apparatus, while balancing liquid flows, conveying using a filtrate pump, conveying using a substituate pump, and/or conveying, using a dialysis liquid pump, wherein the control device or closed-loop control device is further programmed to, at one or more predetermined interruption time points that fall within the duration of the treatment session: interrupt a balancing of the liquid flows, and/or interrupt a calcium solution flow or a conveying action of a calcium pump, a citrate solution flow or a conveying action of a citrate pump, a Heparin solution flow or a conveying action of a Heparin pump, a filtrate flow or a conveying action of the filtrate pump, a substituate flow or a conveying action of a substituate pump, and/or a dialysis fluid flow or a conveying action of a dialysis liquid pump.

    26. The blood treatment apparatus according to claim 25, wherein the blood treatment apparatus comprises a dialysis apparatus, a hemodialysis apparatus, a hemofiltration apparatus or hemodiafiltration apparatus, or an apparatus for chronic renal replacement therapy or for continuous renal replacement therapy.

    27. An effluent bag draining apparatus comprising: an effluent outlet line for guiding effluent out of an effluent bag; a pump section for conveying effluent out of the effluent bag; and a control device programmed to prompt the pump section to convey effluent out of the effluent bag when a predetermined draining time point is reached.

    28. The effluent bag draining apparatus according to claim 27, wherein the control device is programmed to convey effluent out of the effluent bag via the effluent outlet line using the pump section during a predetermined draining time period.

    29. The effluent bag draining apparatus according to claim 27, wherein the control device is in signal communication with a signal emitter or a clock of a blood treatment apparatus, a clock of the effluent bag draining apparatus or an external clock, a network clock, a ward clock, or an atomic clock, and wherein the control device or closed-loop control device is configured, upon receiving a predetermined signal from the signal emitter or upon reaching a predetermined time on the clock, to specify the time at which the predetermined signal is received or the predetermined time reached as the draining time point or to set the predetermined time in relation to this, wherein the blood treatment apparatus comprises a control device or closed-loop control device programmed for controlling or regulating the blood treatment apparatus during a treatment session that treats a patient's blood and that is carried out by an extracorporeal blood tubing set, wherein the blood treatment apparatus, while balancing liquid flows, conveying using a filtrate pump, conveying using a substituate pump, and/or conveying, using a dialysis liquid pump, wherein the control device or closed-loop control device is further programmed to, at one or more predetermined interruption time points that fall within the duration of the treatment session: interrupt a balancing of the liquid flows, and/or interrupt a calcium solution flow or a conveying action of a calcium pump, a citrate solution flow or a conveying action of a citrate pump, a Heparin solution flow or a conveying action of a Heparin pump, a filtrate flow or a conveying action of the filtrate pump, a substituate flow or a conveying action of a substituate pump, and/or a dialysis fluid flow or a conveying action of a dialysis liquid pump.

    30. A system comprising a blood treatment apparatus and an effluent bag draining apparatus, wherein the blood treatment apparatus comprises a control device or closed-loop control device programmed for controlling or regulating the blood treatment apparatus during a treatment session that treats a patient's blood and that is carried out by an extracorporeal blood tubing set, wherein the blood treatment apparatus, while balancing liquid flows, conveying using a filtrate pump, conveying using a substituate pump, and/or conveying, using a dialysis liquid pump, wherein the control device or closed-loop control device is further programmed to, at one or more predetermined interruption time points that fall within the duration of the treatment session: interrupt a balancing of the liquid flows, and/or interrupt a calcium solution flow or a conveying action of a calcium pump, a citrate solution flow or a conveying action of a citrate pump, a Heparin solution flow or a conveying action of a Heparin pump, a filtrate flow or a conveying action of the filtrate pump, a substituate flow or a conveying action of a substituate pump, and/or a dialysis fluid flow or a conveying action of a dialysis liquid pump, and wherein the effluent bag draining apparatus comprises: an effluent outlet line for guiding effluent out of an effluent bag; a pump section for conveying effluent out of the effluent bag; and a control device programmed to prompt the pump section to convey effluent out of the effluent bag when a predetermined draining time point is reached.

    31. The system according to claim 30, wherein the blood treatment apparatus and the effluent bag draining apparatus are separate from each other.

    32. The system according to claim 30, wherein the control device or closed-loop control device of the blood treatment apparatus and the control device of the effluent bag draining apparatus are each programmed such that at least one interruption time point and at least one draining time point occur simultaneously or are offset by a predetermined period of time.

    33. The system according to claim 30, wherein the control device or closed-loop control device of the blood treatment apparatus and the control device of the effluent bag draining apparatus are each programmed such that at least one interruption time period and at least one draining time period overlap each other by at least 50% of the duration of either interruption time period.

    34. The system according to claim 30, wherein the signal emitter or the clock, which is in signal communication with the control device or closed-loop control device of the blood treatment apparatus, and the signal emitter or the clock, which is in signal communication with the control device of the effluent bag draining apparatus, are identical or are synchronised.

    35. A method for draining an effluent bag filled with effluent during a patient's blood treatment using a blood treatment apparatus and an effluent bag draining apparatus comprising an effluent outlet line for guiding effluent out of an effluent bag, a pump section for conveying effluent out of the effluent bag, and a control device programmed to prompt the pump section to convey effluent out of the effluent bag when a predetermined draining time point is reached, wherein an effluent bag, which comprises an effluent outlet opening, is in fluid communication with the blood treatment apparatus and/or is connected to the effluent bag draining apparatus, wherein the effluent outlet opening of the effluent bag is connected to the effluent outlet line of the effluent bag draining apparatus to conduct effluent out of the effluent bag, such that a fluid communication is established between an interior space of the effluent bag and an interior space of the effluent outlet line, wherein the method comprises: at one or more predetermined interruption time points that fall within a duration of a treatment session: stopping a balancing; and/or stopping a calcium solution flow or a conveying action of a calcium pump, a citrate solution flow or a conveying action of a citrate pump, a substituate solution flow or a conveying action of a substituate pump, a Heparin solution flow or a conveying action of a Heparin pump, a filtrate flow or a conveying action of a filtrate pump and/or a dialysis liquid flow or a conveying action of the dialysis liquid pump; and prompting the pump section to convey effluent out from the effluent bag when a predetermined draining time point is reached.

    36. The method according to claim 35, wherein an interruption takes place for a predetermined interruption period.

    Description

    BRIEF DESCRIPTION OF THE FIGURES

    [0100] The present disclosure is exemplarily explained with regard to the accompanying drawing in which same reference numerals refer to the same or similar components. In the figures of the drawing the following applies:

    [0101] FIG. 1 shows in simplified representation, a process flow chart of a blood treatment apparatus according to the present disclosure having an extracorporeal blood circuit and a control device or closed-loop control device according to the present disclosure;

    [0102] FIG. 2 shows an effluent bag draining apparatus according to the present disclosure in a first embodiment; and

    [0103] FIG. 3 shows a highly simplified diagram of a volume flow in an effluent inlet line of a blood treatment apparatus according to the present disclosure over time (top) and a diagram of the volume flow in the effluent outlet line of an effluent bag draining apparatus according to the present disclosure over time (bottom).

    DETAILED DESCRIPTION

    [0104] FIG. 1 shows in a highly simplified representation a process flow chart of a blood treatment apparatus 100 according to the present disclosure, optionally connected to an extracorporeal blood circuit 300 and to a drainage tubing system directed to an effluent bag 400. The effluent bag 400 can be part of the blood treatment device 100 or part of the effluent bag draining apparatus 4000 shown in FIG. 2.

    [0105] The extracorporeal blood circuit 300 includes a first line 301, here in the form of an arterial line section.

    [0106] The first line 301 is in fluid communication with a blood treatment apparatus, here exemplarily a blood filter or dialyzer 303. The blood filter 303 includes a dialysis liquid chamber 303a and a blood chamber 303b, which are separated from each other by a mostly semi-permeable membrane 303c.

    [0107] The extracorporeal blood circuit 300 further includes at least a second line 305, here in the form of a venous line section. Both the first line 301 as well as the second line 305 can serve for being connected to the patient's vascular system (not shown).

    [0108] The first line 301 is optionally connected with a (first) tubing clamp 302 for blocking or closing of line 301. The second line 305 is optionally connected with a (second) tubing clamp 306 for the blocking or closing of line 305.

    [0109] The blood treatment apparatus 100 represented schematically and only by some of its devices in FIG. 1, includes a blood pump 101. During the patient's treatment the blood pump 101 conveys blood through sections of the extracorporeal blood circuit 300 towards the blood filter or dialyzer 303. This is indicated by the small arrows which are used in each of the figures to generally illustrate the direction of flow.

    [0110] Using a pump for dialysis liquid 121 that may be embodied as a roller pump or as any otherwise occluding pump, fresh dialysis liquid is pumped from a source 200 along the dialysis liquid inlet line 104 into the dialysis liquid chamber 303a. The dialysis liquid leaves the dialysis liquid chamber 303a as dialysate, possibly enriched with filtrate, towards the effluent bag 400 and will be referred to herein as effluent.

    [0111] The source 200 may be, for example a bag or a container. The source 200 may also be a fluid line, out of which on-line and/or continuously generated or mixed liquid is provided, for example, a hydraulic outlet or hydraulic port of the blood treatment apparatus 100.

    [0112] A further source 201 with substituate may be optionally provided. It may correspond to the source 200 or be a separate source.

    [0113] An only roughly indicated control device or closed-loop control device 150 can be configured to control or regulate the blood treatment session.

    [0114] The control device or closed-loop control device 150 may be designed to stop a balancing done by the blood treatment apparatus 100 using a clock 160, only roughly indicated, optionally via a signal emitter 170, e.g., at specified times or after specified time intervals.

    [0115] Alternatively, the clock 160 can be intended to be in signal communication with an external clock 5000, e.g., a network clock, a ward clock or an atomic clock, to be synchronized with such a clock or to be identical to it.

    [0116] Further, the clock 160 and/or the signal emitter 170 can optionally be provided, as described in FIG. 2, to be in signal communication with a clock of the effluent bag draining apparatus 4000, e.g., to be synchronized with it.

    [0117] Alternatively or additionally, the signal emitter 170 may be in signal communication with the control device 450 of the effluent bag draining apparatus 4000, in order to prompt, or trigger a draining interval via the pump section 2300, (see FIG. 2).

    [0118] Where the effluent bag 400 is fluidically, form-fitting and/or force-fitting, optionally connected to the blood treatment apparatus 100 is indicated in the bottom right of FIG. 1. An effluent bag draining apparatus 4000 optionally only fluidically connected to the effluent bag 400 as well as its components are first shown in FIG. 2.

    [0119] In addition to the aforementioned blood pump 101, the arrangement in FIG. 1 further includes, purely optionally, a series of other pumps, in each case optional, namely the pump 111 for substituate, the pump 121 for dialysis liquid and the pump 131 for the effluent.

    [0120] The pump 121 is provided to feed dialysis liquid, out of a source 200, for example a bag, via an optional existing bag heater H2 having a heat bag to the blood filter 303, via a dialysis liquid inlet line 104.

    [0121] The thus supplied dialysis liquid exits the blood filter 303 via a dialysate outlet line 102, supported by the optional pump 131, and may be discarded.

    [0122] Upstream of blood pump 101 an optional arterial sensor PS1 is provided. It measures the pressure in the arterial line during the patient's treatment.

    [0123] Downstream of the blood pump 101, but upstream of the blood filter 303 and if provided, upstream of an addition site 25 for Heparin, a further optional pressure sensor PS2 is provided. It measures the pressure upstream of the blood filter 303 (“pre-hemofilter”).

    [0124] Again, a further pressure sensor may be provided as PS4 downstream of the blood filter 303, however preferably upstream of the pump 131 in the dialysate outlet line 102 to measure the filtrate pressure of the blood filter 303.

    [0125] Blood, which leaves the blood filter 303, passes through an optional venous blood chamber 29, which can include a ventilation device 31 and/or a further pressure sensor PS3.

    [0126] The control device or closed-loop control device 150 shown in FIG. 1 can be in cable or wireless signal communication with any of the components referred to herein—at least with the blood pump 101—in order to control or regulate the blood treatment apparatus 100.

    [0127] The optional pump 111 is provided to feed substituate from the optional source 201, for example a bag, via an optional available bag heater H1 having a heat bag, to the second line 305.

    [0128] FIG. 2 shows a effluent bag draining apparatus 4000 according to the present disclosure in a first embodiment.

    [0129] FIG. 2 also shows on the left, a section of the extracorporeal blood circuit 300 of a blood treatment apparatus 100 from FIG. 1, namely the arterial line section 301, which, with reference to FIG. 2, leads from below into the blood chamber 303b of the dialyzer 303. On the opposite side of dialyzer 303 (to the top of FIG. 2), the venous line section 305 leads back out of the blood chamber 303b. Separated from the blood chamber 303b by the semi-permeable membrane 303c is the dialysis liquid chamber 303a, into which fresh dialysis liquid passes via the dialysis liquid inlet line 104 into the dialyzer 303. The dialysis liquid is led downstream of the dialyzer 303, henceforth referred to as filtrate or effluent, using the pump 131 via the dialysate outlet line or effluent inlet line 102 (as it feeds effluent to the effluent bag 400) out from the dialysis liquid chamber 303a towards the effluent bag 400, where it is fed through an effluent inlet opening 400a into an interior of the effluent bag 400. The effluent bag 400 is here exemplarily arranged on or in a bag holder 430, which again is connected to a weighing scale W1 or to another weighing device and may be part of the blood treatment apparatus 100 or effluent bag draining apparatus 4000. Marked with a dot-dash line is an example of a fill level or an example of a liquid level inside the effluent bag 400.

    [0130] The pump section 2300 is activated by a control device 450 during an interruption interval, during which the balancing by the blood treatment apparatus 100 is stopped and with it also, for example the pump 131. It then sucks the effluent located in the effluent bag 400 or parts thereof through the effluent outlet opening 400b, which is optionally arranged to the bottom right of the effluent bag 400 in FIG. 2, and pumps effluent along an effluent outlet line 403, for example into a basin 6000.

    [0131] A clock 460 can be provided in the effluent bag draining apparatus 4000 to determine the start of the pumping activity, for instance in order to determine when there is a draining time point. The effluent bag draining apparatus 4000 can optionally be in signal communication with the clock 160 of the blood treatment apparatus 100, the signal emitter 170, or an external clock 5000 (see FIG. 1).

    [0132] The control device 450 of the effluent bag draining apparatus 4000 may be programmed to start the draining process, at a predetermined time point and exactly for a period of predetermined duration the draining time period, and upon reaching the end of this time period preferably also to end it. If possible, this draining time period preferably will be during, or overlap with an interruption interval in which the blood treatment apparatus 100 is inactive (interruption time period). Preferably, during this draining time period the effluent bag 400 is, in each case, preferably emptied completely (see also FIG. 3).

    [0133] The term “the blood treatment apparatus 100 is inactive” means in this embodiment, that at this point in time at least one of the pumps 111, 121 and 101 (see FIG. 1) is not conveying and/or the balancing is stopped.

    [0134] As indicated in FIG. 2, any two or more of the components of the effluent bag draining apparatus 4000, referred to herein, may be in their entirety or partially, optionally arranged in or on a common housing 4001.

    [0135] Together FIG. 1 and FIG. 2 show a possible embodiment of the system according to the present disclosure.

    [0136] FIG. 3 shows in its upper diagram, an exemplary volume flow Q.sub.in over time t generated by the pump 131 in the effluent inlet line 102.

    [0137] The pump 131 delivers a volume V1 into the effluent bag 400 from the time point t=0 to the time point t=t1, and a volume V2 from the time point t=t1 to the time point t=t2. Hatching is used to display these volumes V1, V2 in the upper diagram of FIG. 2.

    [0138] It can also be seen from the upper diagram that the pump 131 is stopped at predetermined time points t1 and t2, and in each case is not conveying for the predetermined length or duration of an interval I1 or I2 (interruption intervals are denoted by I as interruption).

    [0139] I1, I2 are in each case to be understood here as interruption time durations, and t1 and t2 as interruption times points at which I1, I2 each begin.

    [0140] FIG. 3 shows in its lower diagram a volume flow Q.sub.out with which the pump section 2300 of the effluent outlet line 403 of the effluent bag draining apparatus 4000 delivers effluent out of the effluent bag 400 over the time t.

    [0141] It can be seen from the lower diagram that the pump section 2300 is activated at predetermined time points t3 and t4 and is conveying for the length of a predetermined interval O3 or O4 (draining intervals are denoted here by O as out).

    [0142] O3, O4 are here to be understood in each case as draining time periods, and t3 and t4 as draining time points at which O3, O4 each begin.

    [0143] It can further be seen in the lower diagram that the third time point t3 can be delayed by an optional waiting time after the first time point t1 and the fourth time point t4 can be delayed by an optional waiting period after the second time point t2 (for t1 and t2 see the upper diagram in each case). These time delays can each be of the same length, but they do not have to be. In addition, the intervals O3, O4 are preferably within the intervals I1, I2 or overlap with them.

    [0144] Preferably, within the intervals O3, O4, the same volumes V1 or V2 are conveyed out of the effluent bag 400 by the pump section 2300, as were previously pumped into the effluent bag 400 by the pump 131 before the intervals I1, I2 (in the upper diagram). These volumes V1, V2 are also shown as hatched areas in the lower diagram.

    LIST OF REFERENCE NUMERALS

    [0145] 25 addition point for Heparin (optional) [0146] 29 venous blood chamber (optional) [0147] 31 ventilation device (or venting or de-aeration or de-airing device) [0148] 100 blood treatment apparatus [0149] 101 blood pump [0150] 102 dialysate outlet line, effluent inlet line [0151] 104 dialysis liquid inlet line [0152] 111 pump for substituate [0153] 121 pump for dialysis liquid [0154] 131 pump for dialysate or effluent in effluent inlet line [0155] 150 control device or closed-loop control device [0156] 160 clock [0157] 170 signal emitter [0158] 200 dialysis liquid source [0159] 201 substituate source, optional [0160] 300 extracorporeal blood circuit [0161] 301 first line (arterial line section) [0162] 302 (first) tubing clamp [0163] 303 blood filter or dialyzer [0164] 303a dialysis liquid chamber [0165] 303b blood chamber [0166] 303c semi-permeable membrane [0167] 305 second line (venous line section) [0168] 306 (second) tubing clamp [0169] 400 effluent bag [0170] 400a effluent inlet opening [0171] 400b effluent outlet opening [0172] 403 effluent outlet line, drain line [0173] 430 bag holder [0174] 450 control device [0175] 460 clock [0176] 2300 pump section [0177] 4000 effluent bag draining apparatus [0178] 4001 housing [0179] 5000 clock [0180] 6000 sink or basin; drain; outlet; [0181] H1 bag heater having a bag (substituate) [0182] H2 bag heater having a bag (dialysis liquid) [0183] I1, I2 time interval; interruption interval [0184] O3, O4 time interval; draining interval [0185] PS1, PS2 arterial pressure sensor (optional) [0186] PS3 pressure sensor (optional) [0187] PS4 pressure sensor for measuring the filtrate pressure [0188] t1 first time point; interruption time point [0189] t2 second time point; interruption time point [0190] t3 third time point; draining time point [0191] t4 fourth time point; draining time point [0192] V1 first conveying volume [0193] V2 second conveying volume [0194] W1 weighing scales