Blood treatment device, in particular dialysis device, and method for operating a blood treatment device, in particular dialysis device

Abstract

The invention relates to a blood treatment device, in particular a dialysis device, for extracorporeal blood treatment for use with a blood treatment unit, and to a method for operating such a blood treatment device. The fluid system of the blood treatment device has a connection unit for connecting a container for producing the dialysis fluid, which container is intended for single use and is filled with a powdery concentrate. The blood treatment device provides a treatment mode and a reinfusion mode and is characterised by a controller which is intended to prevent replacement of the container intended for single use shortly before the planned end of treatment, wherein the residual amount of concentrate still present in the container can be used for reinfusion.

Description

[0001] Blood treatment device, in particular dialysis device, and method for operating a blood treatment device, in particular dialysis device

[0002] The invention relates to a blood treatment device, in particular a dialysis device, for extracorporeal blood treatment for use with a blood treatment unit, in particular a dialyzer, which is divided by a semipermeable membrane into a first compartment, which is part of an extracorporeal blood circuit of the blood treatment device, comprising an arterial blood line leading to an inlet of the first compartment and a venous blood line leading from an outlet of the first compartment, and a second compartment, which is part of a fluid system of the blood treatment device. Furthermore, the invention relates to a method for operating such a blood treatment device, in particular a dialysis device.

[0003] Dialysis fluid is generally produced using pre-prepared dialysate concentrates that are diluted with a specified amount of permeate (pure water). Basic concentrates, particularly bicarbonate concentrates, and acidic concentrates, particularly acetate concentrates, are used as concentrates. The permeate and the concentrates are mixed in a so-called mixing circuit of the dialysis machine. In the mixing circuit, the concentrates are added to the permeate in a precisely specified volumetric ratio to establish a specified molar concentration, particularly a specified concentration of bicarbonate or acetate, in the dialysis fluid.

[0004] DE 34 43 911 A1 describes a process in which a liquid concentrate is produced from permeate and a powdered dry concentrate in a container. A line for supplying permeate is connected to an inlet of the container, and a line leading to a mixing point, to which permeate flows via another line, is connected to an outlet of the container. To balance fresh and used dialysis fluid, known dialysis machines have a balancing device. These balancing devices have balancing chambers, each divided into two balancing chamber halves by a flexible membrane, which are operated alternately in successive balancing chamber cycles of consecutive operating cycles. Mixing circuits are known that supply the respective concentrate to the balancing chambers of the balancing device during the balancing of fresh and used dialysis fluid.

[0005] Prefabricated bags filled with a sufficient amount of powdered concentrate for one dialysis treatment can be used to produce dialysis fluid. Conventional dialysis machines have suitable connection units for connecting the concentrate bags to the fluid system.

[0006] During dialysis, the patient's blood flows through the first compartment of the dialyzer, while the dialysis fluid flows through the second compartment. The molar concentration, particularly the bicarbonate concentration, is monitored during dialysis treatment. The volumes of permeate and concentrate are adjusted to achieve the desired bicarbonate concentration in the dialysis fluid. This empties the concentrate bag connected to the dialysis fluid system. At the end of the blood treatment, the amount of concentrate remaining in the concentrate bag should be as small as possible to avoid discarding unused concentrate.

[0007] After blood treatment is complete, the patient is disconnected from the dialysis machine by removing the arterial and venous cannulas of the bloodline system from the patient's artery and vein, respectively. At the end of treatment, the blood still in the bloodline system can be reinfused. For blood reinfusion, only the arterial cannula is removed, leaving the venous cannula connected. The arterial blood line is connected to a reinfusion line through which a reinfusion solution then flows. Reinfusion is terminated when the reinfusion solution flowing via the arterial blood line, through the blood chamber of the dialyzer, and via the venous blood line into the patient is at least largely free of blood. This condition can be detected by an optical sensor. Reinfusion can also be terminated when a predetermined volume of infusion solution has been reinfused.However, the reinfusion volume should be as small as possible to avoid having to remove the fluid administered to the patient using ultrafiltration during subsequent blood treatment. A typical reinfusion volume is 500 ml.

[0008] Blood treatment devices are known in which the treatment fluid produced during blood treatment is used for reinfusion. These blood treatment devices comprise a first treatment fluid flow path, via which the treatment fluid, in particular dialysis fluid, flows in a treatment mode from a mixing point into the second compartment of the blood treatment unit, in particular the dialyzer, and a second treatment fluid flow path, via which the treatment fluid, in particular dialysis fluid, flows in a reinfusion mode from the mixing point through the arterial blood line into the first compartment of the blood treatment unit, in particular the dialyzer.

[0009] Blood treatment devices are also known in which, in the reinfusion mode, the treatment fluid, in particular dialysis fluid, flows from the mixing point through the semipermeable membrane into the first compartment of the blood treatment unit, in particular the dialyzer.

[0010] If a sufficient amount of concentrate is still available in the concentrate bag after the blood treatment has been completed, the reinfusion can be carried out using the same bag with the remaining amount of concentrate. The amount of concentrate in the bag can then be used optimally. As long as there is still a sufficient amount of undissolved concentrate in the concentrate bag, a saturated solution can be produced. However, if only a small amount of undissolved concentrate remains in the bag, a saturated solution is no longer obtained, resulting in a drop in concentration. Since known blood treatment machines provide control of the molar concentration, the drop in concentration can initially be compensated for by increasing the volume flow of the pump metering the liquid concentrate at the mixing point.In practice, however, there are limits to increasing the volume flow of the dosing pump or the volume of added concentrate. These limits are determined by the design of the dosing device in the blood treatment device. Particularly in blood treatment devices that have a mixing circuit, in which the dosing device feeds the concentrate to the balancing chambers of the balancing device, the volume of liquid concentrate fed to a balancing chamber by a pump during a relatively short balancing chamber cycle cannot be increased arbitrarily in order to compensate for a drop in concentration. If an upper limit is reached for the supplied volume, the molar concentration of the finished blood treatment fluid will drop, which is detected by a monitoring device. The monitoring device then triggers an alarm. The operating personnel then replace the empty bag with a full one.This requires interrupting the blood treatment, which is a time-consuming procedure. Replacing the bag with a new one shortly before the end of the scheduled treatment time also wastes resources, as a nearly full bag then has to be discarded.

[0011] The invention is based on the object of creating a blood treatment device that avoids the time-consuming replacement of the container used to produce treatment fluid and allows optimal utilization of the concentrate provided in the container for producing treatment fluid. Another object of the invention is to operate a blood treatment device in such a way that replacement of the concentrate filled with the concentrate used to produce treatment fluid is avoided and the concentrate can be used optimally.

[0012] These objects are achieved according to the invention with the features of the independent patent claims. The dependent claims relate to advantageous embodiments of the invention.

[0013] The embodiments of the invention described below may comprise one or more of the features or combinations of features listed below. A feature designated with an indefinite article may also be present multiple times if the indefinite article is not to be understood as an explicit reference to only one-time use. Designating features with a number, for example "first and second", does not exclude the possibility that these features may be present multiple times beyond the number indicated by the number. When describing all embodiments, the expression "may" should also be understood as "preferably" or "expediently".

[0014] The blood treatment device according to the invention, in particular a dialysis device, is intended for use with a blood treatment unit, in particular a dialyzer. The blood treatment unit is divided by a semipermeable membrane into a first compartment, which is part of an extracorporeal blood circuit of the blood treatment device, comprising an arterial blood line leading to an inlet of the first compartment and a venous blood line leading from an outlet of the first compartment, and a second compartment, which is part of a fluid system of the blood treatment device.

[0015] The fluid system of the blood treatment device according to the invention has a connection unit for connecting a single-use first container filled with a predetermined amount of a powdered first concentrate, in particular bicarbonate, for producing a liquid first concentrate, in particular liquid bicarbonate concentrate, by mixing permeate and powdered first concentrate in the container. The connection unit, which can be part of the housing of the blood treatment device, allows for easy connection of the container to the fluid system of the blood treatment device. The container can be a flexible plastic bag.

[0016] In addition, the blood treatment device has a first mixing point for mixing permeate and the liquid first concentrate, in particular liquid bicarbonate concentrate, to produce the treatment fluid, in particular dialysis fluid. In this context, a mixing point is understood to be a point in the fluid system where multiple fluids can be combined. A mixing point can be a point where lines converge. However, a mixing point can also be a chamber with inlets and outlets.

[0017] Furthermore, the blood treatment device comprises a liquid concentrate flow path configured such that the liquid first concentrate, in particular liquid bicarbonate concentrate, flows from the connection unit to the first mixing point, wherein a first concentrate pump is provided in the liquid concentrate flow path. The liquid concentrate flow path can comprise a plurality of lines or line sections.

[0018] In one embodiment, the blood treatment device further comprises a first treatment fluid flow path configured such that the treatment fluid, in particular dialysis fluid, flows from the first mixing point into the second compartment of the blood treatment unit, in particular the dialyzer, and a second treatment fluid flow path configured such that the treatment fluid, in particular dialysis fluid, flows from the first mixing point through the arterial blood line into the first compartment of the blood treatment unit, in particular the dialyzer. Both flow paths can comprise a plurality of lines or line sections, wherein both flow paths can also comprise at least parts of the same lines or line sections.

[0019] The second treatment fluid flow path can be configured such that the treatment fluid, in particular dialysis fluid, flows through the entire length of the arterial blood line in reinfusion mode or flows through only a section of the arterial blood line. In other words, in reinfusion mode, a connection can be provided between the first mixing point and the first compartment via an arterial end of the arterial blood line, in particular via an arterial end of the arterial blood line via which a patient is connected to the arterial blood line in treatment mode, or in reinfusion mode, a connection can be provided between the first mixing point and the first compartment via a branch on the arterial blood line, in particular via a branch of the arterial blood line via which a patient is not connected to the arterial blood line in treatment mode.

[0020] In a further embodiment, the blood treatment device further comprises a first treatment fluid flow path configured such that the treatment fluid, in particular dialysis fluid, flows from the first mixing point into the second compartment of the blood treatment unit, in particular the dialyzer, and optionally one or no second treatment fluid flow path configured such that the treatment fluid, in particular dialysis fluid, flows from the first mixing point through the arterial blood line into the first compartment of the blood treatment unit, in particular the dialyzer. Both flow paths can comprise a plurality of lines or line sections, wherein both flow paths can also comprise at least parts of the same lines or line sections.In this embodiment, in a reinfusion mode, the treatment fluid, in particular dialysis fluid, can flow across the semipermeable membrane into the first compartment. A blood treatment device with the second treatment fluid flow path can be suitable or be such for performing a hemodiafiltration and a hemodialysis treatment. Such a blood treatment device can additionally be suitable or be such for performing an ultrafiltration treatment and / or a hemofiltration treatment. A blood treatment device with the second treatment fluid flow path can be suitable or be such only for performing a hemofiltration treatment. The blood treatment device without the second treatment fluid flow path can be suitable for performing hemodialysis but not for performing a hemodiafiltration treatment.

[0021] A treatment fluid conveying device is provided to convey the treatment fluid at a predetermined volume flow rate in the first and optionally second treatment fluid flow path. The treatment fluid conveying device can comprise one or more pumps. In this context, pumps are also understood to mean balancing chambers with which fluid can be conveyed.

[0022] The blood treatment device is characterized in that it provides a treatment mode and a reinfusion mode. In the treatment mode, the treatment fluid, in particular dialysis fluid, is conveyed by the treatment fluid conveying device via the first treatment fluid flow path from the first mixing point into the second compartment of the blood treatment unit, in particular the dialyzer. In the reinfusion mode, the fluid flow through the first treatment fluid flow path can be interrupted, and treatment fluid, in particular dialysis fluid, can be conveyed by the treatment fluid conveying device via the second treatment fluid flow path from the first mixing point through the arterial blood line into the first compartment of the blood treatment unit.In one embodiment, in the reinfusion mode, treatment fluid, in particular dialysis fluid, can be conveyed via the first treatment fluid flow path from the first mixing point into the second compartment of the blood treatment unit, in particular dialyzer, through the semipermeable membrane into the first compartment of the blood treatment unit.

[0023] In the treatment mode, the treatment fluid, in particular dialysis fluid, can be conveyed from the blood treatment unit into another part of the fluid system of the blood treatment device.

[0024] Even if the fluid that is transferred into the first compartment in the reinfusion mode is referred to as treatment fluid or dialysis fluid, it is not absolutely necessary or may not be the case that this fluid contributes to the purification of the blood, i.e. in the narrower sense to the treatment or dialysis treatment.

[0025] The blood treatment device is designed in such a way that it can be configured accordingly for the treatment mode and the reinfusion mode. For example, setting up the blood treatment device may require manually connecting or removing cannulas or connecting or disconnecting tubes.

[0026] The blood treatment device further comprises a control and computing unit for controlling the blood treatment device and a user interface that interacts with the control and computing unit. The user interface can be any interface with which the operating personnel can interact with the treatment device. The user interface can, for example, have switches, buttons, optical, acoustic, tactile display elements, etc. For example, the user interface can comprise a touchscreen and provide menu navigation. The control and computing unit receives the measured values ​​from a substance concentration measuring unit to record a measured value correlating with the concentration of a substance, in particular bicarbonate concentration, in the treatment fluid. A measured value correlating with the substance concentration can, for example, be the conductivity of the dialysis fluid.

[0027] The control and computing unit is configured such that the volume flow of the first concentrate pump is adjusted in the treatment mode such that the treatment liquid has a predetermined molar concentration, in particular bicarbonate concentration.

[0028] Furthermore, the control and computing unit is configured to determine at least one parameter characteristic of the efficiency of the dialysis treatment. In this context, a parameter characteristic of the efficiency of the dialysis treatment refers to all variables that influence the success of the treatment, such as the treatment duration, the consumption of treatment fluid, the dialysis dose, etc. To determine this parameter, the control and computing unit can interact with the relevant measuring units and read the relevant data from a storage unit. Devices for determining the dialysis dose, for example, are state of the art.

[0029] The invention assumes that the volume flow of the first concentrate pump is adjusted in the treatment mode so that the treatment liquid has the desired molar concentration, in particular the bicarbonate concentration. A reduction in the molar concentration in the liquid concentrate is compensated, for example, by an increase in the volume flow. However, if the concentrate is largely consumed, the desired molar concentration can no longer be achieved. For this case, the control and processing unit is configured to generate an alarm control signal (error message).

[0030] The control of the blood treatment device according to the invention makes it possible to avoid replacing the container shortly before the planned end of treatment and to use the remaining amount of concentrate still in the container for reinfusion.

[0031] The control and computing unit is configured such that, after the alarm control signal is generated, a check routine is started to compare the at least one parameter characteristic of the efficiency of the dialysis treatment with a predetermined target value. It is assumed that the actual blood treatment should only be terminated and reinfusion performed once the target value has been reached. The control and computing unit is configured such that a reinfusion control signal is generated for the user interface if the parameter is greater than or equal to the target value. The user interface is configured such that, after receiving the reinfusion control signal, an optical and / or acoustic and / or tactile signal is generated as a prompt to the user to initiate reinfusion mode using the first container.Consequently, the user is only prompted to initiate a reinfusion if certain criteria previously defined by the parameter are met. The invention is based on the idea that when the alarm signal is generated, the container should not be replaced, but rather the actual treatment should be terminated. The invention is based on the finding that when the alarm signal is generated, there is still sufficient concentrate in the container to allow for a reinfusion.

[0032] An embodiment of the blood treatment device according to the invention or of the method according to the invention provides that the control and computing unit determines the volume of the treatment fluid actually consumed in the treatment mode as a parameter characteristic of the efficiency of the dialysis treatment.

[0033] The control and computing unit reads the expected volume of treatment fluid, in particular dialysis fluid, to be produced using the first container from a memory. Different values ​​for different containers, for example, 180 l for a 600 g bag, can be stored in the memory. These values ​​can have been previously entered using the user interface.

[0034] The control and computing unit then compares the volume of treatment fluid actually used at the time the alarm control signal is generated with the expected volume of treatment fluid and generates the reinfusion control signal for the user interface if the volume of treatment fluid actually used at the time the alarm control signal is generated, i.e. at the time at which the actual blood treatment is to be ended and reinfusion is to take place, is equal to or greater than the expected volume of treatment fluid. In practice, it may happen that the desired molar concentration cannot be achieved simply because channels form in the powdered concentrate when permeate flows through the concentrate in the container. At this point, however, there is still sufficient concentrate in the bag.In practice, the bag should then be shaken to remove the channels. The configuration of the control and processing unit prevents premature termination of blood treatment by allowing reinfusion to be initiated only when treatment is actually intended to be completed.

[0035] A further embodiment of the blood treatment device according to the invention or of the method according to the invention provides that the control and computing unit determines the dialysis dose achieved in the treatment mode as a parameter characteristic of the efficiency of the dialysis treatment. The invention assumes that the actual treatment can be discontinued and reinfusion can be performed once the dialysis dose, i.e., the treatment goal, has been reached.

[0036] The control and computing unit reads a predefined minimum dialysis dose from a memory, which may have been previously entered using the user interface, and compares the dialysis dose achieved in the treatment mode at the time the alarm control signal is generated with the minimum dialysis dose. The reinfusion control signal is generated for the user interface if the dialysis dose achieved in the treatment mode at the time the alarm control signal is generated is greater than or equal to the minimum dialysis dose. At this point, the actual treatment can be terminated.

[0037] A further embodiment of the blood treatment device according to the invention or of the method according to the invention provides that the control and computing unit determines the elapsed treatment time as a parameter characteristic of the efficiency of the dialysis treatment. The control and computing unit reads a predetermined minimum treatment time from a memory and compares the treatment time elapsed at the time the alarm control signal is generated with the minimum treatment time. The reinfusion control signal is generated for the user interface if the treatment time elapsed at the time the alarm control signal is generated is greater than or equal to the minimum treatment time.

[0038] The control and computing unit can be configured such that only one of the above criteria is met. Preferably, the control and computing unit checks all criteria before generating the reinfusion control signal.

[0039] To carry out the reinfusion using the same container, a further embodiment of the blood treatment device according to the invention or of the method according to the invention provides various measures to ensure that a sufficient volume of treatment fluid for the reinfusion can be provided using the same container. In this respect, the blood treatment device automatically specifies crucial blood treatment parameters for the reinfusion. The control and computing unit is configured such that a first molar concentration, in particular bicarbonate concentration, is set in the treatment fluid, which is lower than the molar concentration, in particular bicarbonate concentration, set in the treatment fluid in the treatment mode.

[0040] The control and computing unit can be configured for the reinfusion mode such that the volume flow of the treatment fluid delivery device in the reinfusion mode is set to a predetermined value that is lower than the volume flow of the treatment fluid set by the control and computing unit in the treatment mode. A lower flow rate is particularly advantageous in an embodiment of the blood treatment device according to the invention in which the treatment fluid delivery device comprises a balancing device that has at least one balancing chamber divided into two balancing chamber halves for balancing fresh and used dialysis fluid. In this embodiment, the reduction in the volume flow is associated with a lengthening of the balancing chamber cycles in which the balancing chambers are filled and emptied.Extending a balancing chamber cycle allows for the addition of liquid concentrate over a longer period of time. This has the advantage that a larger volume of liquid concentrate can be added with the concentrate pump during a balancing chamber cycle, which is necessary because the remaining amount of concentrate in the container can only produce a liquid concentrate with a low molar concentration.

[0041] A second concentrate may be required to produce the treatment fluid. Dialysis fluid, for example, is produced from a bicarbonate concentrate and an acetate concentrate. A further embodiment therefore provides that the fluid system of the blood treatment device comprises a second connection unit for connecting a second container filled with a predetermined amount of a preferably liquid second concentrate, in particular acetate. Furthermore, the blood treatment device comprises a second concentrate flow path configured such that the liquid second concentrate, in particular liquid acetate concentrate, flows from the second connection unit to a second mixing point, wherein a second concentrate pump is provided in the second concentrate flow path.The control and computing unit is configured such that the volume flow of the second concentrate pump is adjusted in the treatment mode such that the treatment liquid has a predetermined second molar concentration, in particular acetate concentration.

[0042] For the reinfusion mode using the first container, the control and computing unit is configured such that, in the reinfusion mode, a second molar concentration, in particular acetate concentration, is set in the treatment fluid, which is equal to the second molar concentration, in particular bicarbonate concentration, set in the treatment fluid in the treatment mode. Consequently, the dialysis device is operated in the reinfusion mode with an unchanged acetate concentration.

[0043] An embodiment of the invention is explained in more detail below with reference to the drawings.

[0044] They show:

[0045] Fig. 1 is a simplified schematic representation of the components of a blood treatment device according to the invention in treatment mode,

[0046] Fig. 2 is a simplified schematic representation of the components of the blood treatment device in reinfusion mode and Fig. 3 shows the bicarbonate concentration of the liquid bicarbonate concentrate and the volume of liquid bicarbonate concentrate added by the concentrate pump during a balance chamber cycle as a function of the volume of dialysis fluid produced by the concentrate bag.

[0047] Fig. 1 shows a simplified schematic representation of an embodiment of the blood treatment device according to the invention, which is a dialysis device. Therefore, the blood treatment device is referred to below as a dialysis device. Even if a dialysis fluid is specifically mentioned, the explanations also apply to a treatment fluid in general.

[0048] The dialysis device comprises a blood treatment unit 1, hereinafter referred to as the dialyzer, which is divided by a semipermeable membrane 2 into a first compartment 3, hereinafter referred to as the blood chamber 3, and a second compartment 4, hereinafter referred to as the dialysis fluid chamber. An arterial blood line 5 is connected to the inlet 3A of the blood chamber 3, and a venous blood line 6 is connected to the outlet 3B of the blood chamber 3. The patient's blood is pumped in the extracorporeal blood circuit I by a blood pump 7 provided in the arterial blood line 5. The arterial blood line 5 has an arterial patient access 5A (cannula), and the venous blood line 6 has a venous patient access 6A (cannula).An arterial shut-off device 5B is arranged in the arterial blood line 5 and a venous shut-off device 6b is arranged in the venous blood line 6 in order to be able to separate the patient connected to the dialysis device via the cannulas.

[0049] The fluid system II of the dialysis machine has a balancing device 8, which is described in detail in DE 28 38 414 C2.

[0050] The balancing device 8 comprises a first balancing chamber 9 and a second balancing chamber 10. The balancing chambers 9, 10 each have a rigid housing which is divided by a flexible membrane 11, 12 into a first and a second balancing chamber half 9A, 9B and 10A, 10B respectively.

[0051] A first section 13A of a supply line 13 for fresh dialysis fluid, in which a first shut-off device 14 is arranged, leads to an inlet of the first balancing chamber half 9A of the first balancing chamber 9, and a second section 13B of the supply line 13 for fresh dialysis fluid, in which a second shut-off device 15 is arranged, leads to an inlet of the second balancing chamber half 10B of the second balancing chamber 10. A first section 16A of a discharge line 16 for used dialysis fluid, in which a third shut-off device 17 is arranged, leads from an outlet of the second balancing chamber half 9B of the first balancing chamber 9 to an outflow 18. A second section 16B of the discharge line 16 for used dialysis fluid, in which a fourth shut-off device 19 is arranged, leads from an outlet of the first balancing chamber half 10A of the second balancing chamber 10 to the outflow 18.

[0052] An outlet of the first balancing chamber half 9A of the first balancing chamber 9 and an outlet of the second balancing chamber half 10B of the second balancing chamber 10 are connected via a first and second section 20A, 20B of a supply line 20 for fresh dialysis fluid to an inlet 4A of the dialysis fluid chamber 4 of the dialyzer 1, respectively, with a fifth and sixth shut-off device 21, 19 being arranged in the first and second sections of the supply line 20. An outlet of the dialysis fluid chamber 4 of the dialyzer 1 is connected via a discharge line 23 for used dialysis fluid to an inlet of the second balancing chamber half 9B of the first balancing chamber 9 and to an inlet of the first balancing chamber half 10A of the second balancing chamber 10. A seventh and eighth shut-off device 24, 25 are arranged in the corresponding line sections 23A, 23B of the discharge line 23. The shut-off devices can be electromagnetically or pneumatically actuated valves.The shut-off devices form two groups of shut-off devices, with the first, third, sixth, and eighth shut-off devices 14, 17, 19, 25 forming a first group and the second, fourth, fifth, and seventh shut-off devices 15, 22, 21, 24 forming a second group. A dialysis fluid pump 27 is arranged in the discharge line 23 to pump the dialysis fluid from the balancing device 8 into the dialysis fluid chamber 4 of the dialyzer 1.

[0053] The dialysis machine has a central control and computing unit 26, which controls the individual components of the dialysis machine. These components are connected to the control and computing unit 26 via control or data lines not shown in Fig. 1. The control unit can have a general processor, a digital signal processor (DSP) for continuously processing digital signals, a microprocessor, an application-specific integrated circuit (ASIC), an integrated circuit consisting of logic elements (FPGA), or other integrated circuits (IC) or hardware components to carry out the individual method steps. A data processing program (software) can run on the hardware components to carry out the method steps. A plurality or combination of the various components is also possible.

[0054] The control and computing unit 26 is configured such that the electromagnetically actuated shut-off devices 14, 17, 19, 25 of the first group are open when the shut-off devices 15, 22, 21, 24 of the second group are closed, or vice versa. As a result, the two balancing chambers 9, 10 operate alternately, with the balancing chamber halves 9A, 9B and 10A, 10B being alternately filled and emptied in successive balancing chamber cycles. The filling and emptying of the chambers occurs in individual balancing chamber cycles of a working cycle of consecutive working cycles.

[0055] For example, if the shut-off devices 14, 17, 19, 25 of the first group are open, fresh dialysis fluid is pumped into the first balancing chamber half 9A of the first balancing chamber 9, while used dialysis fluid flows from the second balancing chamber half 9B of the first balancing chamber 9 into the drain 18. Fresh dialysis fluid flows from the second balancing chamber half 10B of the second balancing chamber 10 into the dialysis fluid chamber 4 of the dialyzer 1, and used dialysis fluid flows into the first balancing chamber half 10A of the second balancing chamber 10.

[0056] The blood treatment device comprises a dosing device 28 for filling the balancing chambers 9, 10 of the balancing device 8 with permeate (pure water) and concentrates in a predetermined mixing ratio, which is described below.

[0057] The dosing device 28 has a permeate source 29, in which permeate is provided for producing the dialysis fluid. A permeate delivery line 30 leads from the permeate source 29 to a first mixing point 31, where a first concentrate can be added. From the first mixing point 31, the supply line 13 branches off, leading to the balancing chambers 9, 10, so that fluid can flow into the balancing chambers of the balancing device. A shut-off device 32 is arranged in the supply line 13 so that the fluid supply can be interrupted.

[0058] The dosing device 28 comprises a first connection unit 32 and a second connection unit 33. A first container 34 containing a powdered first concentrate (e.g., bicarbonate or sodium hydrogen carbonate powder (NaHCO3) to be processed into ready-to-use bicarbonate in the dialysis machine) can be connected to the first connection unit 32. A second container 35 containing a liquid second concentrate (e.g., acetate or citrate) can be connected to the second connection unit 33. The first container is referred to below as the bicarbonate bag 34 and the second container as the acetate bag 35.

[0059] When the bicarbonate bag 34 and the acetate bag 35 are connected to the fluid system II of the dialysis machine, permeate flows from a permeate source 36 via a first feed line 37 into the bicarbonate bag 34. In the bicarbonate bag 34, permeate and bicarbonate are mixed. The liquid bicarbonate concentrate flows via a bicarbonate feed line 39 to the first mixing point 31, and the liquid acetate concentrate flows via an acetate feed line 40 to a second mixing point 41 on the feed line 13 downstream of the first mixing point 31. To feed the concentrates, a first concentrate pump 42 is arranged in the bicarbonate feed line 39 and a second concentrate pump 43 is arranged in the acetate feed line 40. The two concentrate pumps 42, 43 are volumetric pumps that feed a predetermined volume of liquid concentrate with one stroke.

[0060] In the present embodiment, the supply line 13 for fresh dialysis fluid is part of a treatment fluid flow path through which dialysis fluid flows from the first mixing point 31 into the dialysis fluid chamber 4 of the dialyzer 1. The bicarbonate delivery line 30 represents a first liquid concentrate flow path through which liquid bicarbonate concentrate flows from the first connection unit 32 to the first mixing point, and the acetate delivery line 40 represents a second liquid concentrate flow path through which liquid acetate concentrate flows from the second connection unit 33 to the second mixing point 41.

[0061] In the present embodiment, the dialysis fluid pump 27 together with the balancing device 28 represents a treatment fluid conveying device for conveying the dialysis fluid at a predetermined volume flow in the treatment fluid flow path, or the treatment fluid conveying device comprises the dialysis fluid pump 27 and the balancing device 28.

[0062] The control and computing unit 26 is configured such that, in a balancing chamber cycle during the filling phase, the two concentrates are metered at the respective mixing points 31, 41. If, for example, in a balancing chamber cycle during the filling phase, the shut-off devices 14, 17, 19, 25 of the first group are opened to pump dialysis fluid into the first balancing chamber half 9A of the first balancing chamber 9, the first volumetric concentrate pump 42 is activated to suck a predetermined amount of liquid bicarbonate concentrate, for example 1050 pL in a double stroke, from the bicarbonate bag 34 and to meter it into the permeate in the feed line 13 at the mixing point 31. The second concentrate pump 43 is controlled accordingly by the control and computing unit 26. The time interval for the metering must not be longer than the duration of a balancing chamber cycle.Complete filling of the respective balance chamber can be ensured, for example, by monitoring the filling pressure. The number of strokes or the duration of the time intervals at which the concentrates are metered with the concentrate pumps 42, 43 determines the volumetric ratio of permeate to concentrate, i.e., the bicarbonate or acetate concentration.

[0063] The blood treatment device has a measuring unit 44 that interacts with the control and computing unit and includes a first sensor 44A, in particular a conductivity sensor, for measuring the bicarbonate concentration in the bicarbonate delivery line 39 and a second sensor 44B, in particular a conductivity sensor, for measuring the acetate concentration in the acetate delivery line 40 and a third sensor 44C for measuring the bicarbonate or acetate concentration in the dialysis fluid supply line 20. The control and computing unit 26 is configured such that the volume flow of the first or second concentrate pump 42, 43 is adjusted such that the finished dialysis fluid flowing through the dialysis fluid supply line 20 into the dialysis fluid chamber 4 of the dialyzer 1 has the desired bicarbonate concentration or acetate concentration.

[0064] The dialysis machine further comprises a user interface 46 connected to the control and processing unit 26 via a data line 45. The user interface 46 comprises a touch-sensitive screen 46A on which the user is assisted in operating the dialysis machine with menu guidance. The user interface 46 also comprises an acoustic and / or tactile signal generator 46C. In addition to the treatment mode for the actual dialysis treatment (Fig. 1), the dialysis machine also provides a reinfusion mode. Fig. 2 shows the dialysis machine in reinfusion mode.

[0065] When the dialysis device is operated in reinfusion mode, in one embodiment, dialysis fluid flows via a second treatment fluid flow path from the first mixing point 31 through the arterial blood line 5 into the blood chamber 3 of the dialyzer 1. In reinfusion mode, the fluid flow into the dialysis fluid chamber 4 of the dialyzer 1 can be interrupted. The fluid flow can be interrupted by closing shut-off devices 49, 50 arranged in the supply and discharge lines 2023, in particular hose clamps actuatable by the computing and control unit 26.

[0066] The second treatment fluid flow path comprises a reinfusion line 47 connected to the supply line 23 for fresh dialysis fluid, in which a shut-off device 48, in particular a hose clamp actuatable by the computing and control unit 26, is arranged. This shut-off device 48 is closed by the computing and control unit in the treatment mode and opened in the reinfusion mode. For reinfusion, the arterial cannula 5A can be withdrawn from the patient's artery, and the reinfusion line 47 is connected to the arterial cannula 5A, while the venous cannula 6A remains in the patient's vein. For the conversion of the dialysis device, the shut-off devices 5A, 6A arranged in the venous and arterial blood lines 5, 6 can be closed.For the purposes of this description, the cannula may be a line section having a needle, or may be a connector, in particular a Luer connector, which is connected to a line section having a needle for treatment.

[0067] For reinfusion, the needle can therefore be withdrawn from the artery and connected to the reinfusion line 47, or the arterial line can be separated from the needle section at the connector and then connected to the reinfusion line 47 via the connector. The connection can be a direct connection or a connection via an intermediate piece. In the present embodiment, the dialysis fluid is pumped in the first treatment fluid flow path by the dialysis fluid pump 27 or the balancing device 28, and in the second treatment fluid flow path by the blood pump 7.

[0068] Consequently, during reinfusion, fresh dialysis fluid can flow as a reinfusion solution through the arterial blood line 5 into the dialysis fluid chamber 3 and out of the dialysis fluid chamber 3 through the venous blood line 6 until the fluid present at the venous cannula 6A is at least largely free of blood. During reinfusion, the blood present in only a portion of the venous blood line 6 can be replaced by the dialysis fluid.

[0069] The control of the respective shut-off devices can be carried out by the control and computing unit 26 after the user has called up the reinfusion mode. In the reinfusion mode, certain treatment parameters can be specified by the control and computing unit 26 and / or set by the user.

[0070] The dialysis device provides for monitoring the efficiency of the dialysis treatment. The control and computing unit 26 is configured such that during the blood treatment, the dialysis dose kt / V, where k is the clearance, t is the effective treatment time, and V is the urea volume, is determined as a parameter characteristic of the efficiency of the dialysis treatment.

[0071] The operation of the dialysis device is explained in detail below with reference to Fig. 3. Fig. 3 shows the bicarbonate concentration Cbic [mmol / L] of the liquid bicarbonate concentrate and the volume Vbic [pL] of liquid bicarbonate concentrate metered in during a balance chamber cycle with the first concentrate pump 42 as a function of the volume Vd [L] of dialysis fluid produced with the bicarbonate bag 34 during a dialysis treatment simulated with a model.

[0072] During blood treatment, the control and computing unit 26 sets a volume flow Vbic of 1050 pL for the first concentrate pump 42, resulting in the desired bicarbonate concentration Cbic of 1200 mmol / L in the liquid bicarbonate concentrate. If, at the end of the dialysis treatment, the residual amount of bicarbonate in the bicarbonate bag is no longer sufficient to produce a saturated bicarbonate solution, the bicarbonate concentration Cbic drops sharply. The control and computing unit 26 compensates for the drop in bicarbonate concentration by increasing the volume flow Vbic of the first concentrate pump 42. When the volume flow Vbic has reached the maximum value of 2200 pL, the control and computing unit 26 generates an alarm control signal, which the user interface 46 receives, so that the signal generator 46D of the user interface 46 emits an acoustic and / or tactile alarm.The control and computing unit 26 then starts a checking routine to check whether the following criteria are met.

[0073] The control and computing unit 26 compares the dialysis dose kt / V achieved with the dialysis treatment at the time the alarm control signal is generated with a minimum dialysis dose read by the control and computing unit from a memory. The control and computing unit 26 determines that a first criterion is met if the dialysis dose kt / V is greater than or equal to the minimum dialysis dose. In the present embodiment, the control and computing unit 26 determines that this criterion is met.

[0074] In addition, the control and computing unit 26 compares the volume Vd of dialysis fluid produced with the bicarbonate bag 34 at the time the alarm control signal is generated, i.e., the volume of dialysis fluid consumed in the treatment mode, with the expected volume of dialysis fluid to be produced using the bicarbonate bag 34, which the control and computing unit 26 reads from a memory 26A. The second criterion is met when the volume Vd of the dialysis fluid actually consumed is equal to or greater than the expected volume. In the present embodiment, the expected volume Vd = 180 L. Fig. 3 shows that the volume flow of the first concentrate pump 34 has reached the maximum value of 2200 pL at a time when 187.5 L of dialysis fluid have flowed through the dialysis fluid chamber 4 of the dialyzer 1.The control and computing unit 26 thus determines that the second criterion is also met.

[0075] Furthermore, the control and computing unit 26 compares the treatment time t elapsed at the time the alarm control signal was generated with a minimum treatment time read from the memory 26A. The third criterion is met if the treatment time t elapsed at the time the alarm control signal was generated is greater than or equal to the minimum treatment time. In the present embodiment, it is assumed that the third criterion is also met.

[0076] Since all criteria are met, the control and computing unit 26 generates a reinfusion control signal, which the user interface receives. However, it is also possible for a reinfusion control signal to be generated even if only individual criteria are met. The user interface 46 then emits an optical signal prompting the user to initiate reinfusion mode using the same bicarbonate bag 34. The optical signal can be a text 46B (Initiate Reinfusion!) displayed on the touch screen 46A. The user can now prepare the dialysis machine for reinfusion or ignore the dialysis machine's prompt to initiate reinfusion mode and remove the old bicarbonate bag and connect a new bicarbonate bag to the dialysis machine.

[0077] If the user decides to reinfuse using the same bicarbonate bag, they confirm this during the menu navigation by pressing a button 46C on the touchscreen 46A. The control and computing unit 26 then switches to reinfusion mode. In reinfusion mode, the control and computing unit 26 sets the bicarbonate concentration of the dialysis fluid to a value that is lower than the bicarbonate concentration c Cbic set in the treatment mode. In the present exemplary embodiment, the control and computing unit 26 sets a bicarbonate concentration C.bic.Reinf of 24 mmol / L, which is sufficient for reinfusion. The acetate concentration of the dialysis fluid set by the control and computing unit in the treatment mode, for example, 3 mmol / L, is not changed by the control and computing unit 26 in reinfusion mode.

[0078] In the reinfusion mode, the control and computing unit 26 sets the volume flow of the treatment fluid conveying device to a predetermined value which is lower than the volume flow of the dialysis fluid set by the control and computing unit in the treatment mode. For example, in the reinfusion mode, the control and computing unit 26 sets a dialysis fluid flow Qd.Reinf.min of 300 mL / min. In the present exemplary embodiment, the lower dialysis fluid flow during reinfusion has the advantage that the duration of a balancing chamber cycle is extended, for example to T.BC = 5.8 s. Longer balancing chamber cycles T have the advantage that a larger volume of concentrate can be metered in in one balancing chamber cycle. In the present exemplary embodiment, a volume of a balancing chamber V.bic can then be used in one balancing chamber cycle.max of 31.0 ml a maximum volume of bicarbonate concentrate of 3 x 2000 pL = 6000 pL can be added.

[0079] To achieve a bicarbonate concentration in the dialysis fluid of 24+3 mmol / L, the bicarbonate bag 34 must deliver a concentration C.bic.bibag of at least 140 mmol / L, so that sufficient bicarbonate is present in the maximum dosing volume V.bic.max of 6000 pL. This lower limit is indicated by a dashed line in Fig. 3.

[0080] The amount of bicarbonate available for reinfusion in the bicarbonate bag 34 can be determined from the area between the point at which the dosing volume of the first concentrate pump 42 has reached the maximum dosing volume V.bic.dial.max of 2,200 pL and the point at which the bicarbonate concentration C.bic.bibag falls below 140 mmol / L. The corresponding area is marked with a hatch in Fig. 3.

[0081] During the blood treatment simulation, it was shown that the residual volume of bicarbonate in the bicarbonate bag 34 is sufficient for reinfusion if the reinfusion control and processing unit 26 makes the settings described above. With the residual volume of bicarbonate, a reinfusion volume Vd.Reinf. of 2.1 L can be achieved.

[0082] Further embodiments are explained with reference to Figure 2.

[0083] In a further embodiment, in reinfusion mode, the reinfusion line 47 can be connected to the arterial blood line 5 via a port (not shown). This port can be provided upstream or downstream of the blood pump 7. In other words, the reinfusion line 47 opens into a branch from the blood line 5. Otherwise, the features described with reference to Fig. 1 can also be implemented in this embodiment. In this embodiment, the reinfusion line 47 can also be connected to the port in treatment mode and used for pre-dilution, i.e., supplying dialysis fluid into the blood upstream of the dialyzer 1.In this embodiment, a patient-side end of the arterial blood line 5 can be connectable or connected to a port on the venous blood line 6 for reinfusion, or both the arterial blood line 5 and the venous blood line 6 can be connected to the patient's vascular system via a cannula 5A, 6A for reinfusion.

[0084] In a further embodiment, reinfusion can occur via the semipermeable membrane between the first compartment 3 and the second compartment 4. In other words, in reinfusion mode, the dialysis fluid can be supplied to the second compartment 4 of the dialyzer 1 via the first treatment fluid flow path and then be or can be supplied to the first compartment 3 via the semipermeable membrane 2. Otherwise, the features described with reference to Fig. 1 can also be implemented in this embodiment. In these embodiments, too, a patient-side end of the arterial blood line 5 can be or can be connected to the venous blood line 6 by means of a port for reinfusion, or both the arterial blood line 5 and the venous blood line 6 can each be connected to the patient's vascular system via a cannula 5A, 6A for reinfusion.

Claims

CLAIMS 1. A blood treatment device, in particular a dialysis device, for extracorporeal blood treatment for use with a blood treatment unit (1), in particular a dialyzer, which is divided by a semipermeable membrane (2) into a first compartment (3), which is part of an extracorporeal blood circuit (I) of the blood treatment device, which comprises an arterial blood line (5) leading to an inlet (3A) of the first compartment (3) and a venous blood line (6) leading from an outlet (3B) of the first compartment (3), and a second compartment (4), which is part of a fluid system (II) of the blood treatment device, wherein the fluid system (II) of the blood treatment device comprises: a first connection unit (32) for connecting a single-use first container (34) which is filled with a predetermined amount of a powdered first concentrate, in particular bicarbonate,for producing a liquid first concentrate, in particular liquid bicarbonate concentrate, by mixing permeate and powdered first concentrate in the container, a first mixing point (31) for mixing permeate and liquid first concentrate, in particular liquid bicarbonate concentrate, for producing the treatment fluid, in particular dialysis fluid, a liquid concentrate flow path which is designed such that the liquid first concentrate, in particular liquid bicarbonate concentrate, flows from the first connection unit (32) to the first mixing point (31), wherein a first concentrate pump (42) is provided in the liquid concentrate flow path, a first treatment fluid flow path designed such that the treatment fluid, in particular dialysis fluid, flows from the first mixing point (31) into the second compartment (4A) of the blood treatment unit (4), in particular the dialyzer, wherein a treatment fluid conveying device is provided for conveying the treatment fluid at a predetermined volume flow in the first treatment fluid flow path, the blood treatment device provides a treatment mode in which the treatment fluid, in particular dialysis fluid, is conveyed by the treatment fluid conveying device via the first treatment fluid flow path from the first mixing point (31) into the second compartment (4) of the blood treatment unit (1), in particular the dialyzer, and optionally from the blood treatment unit (1) into a further part of the fluid system (II) of the blood treatment device (1), and the The blood treatment device provides a reinfusion mode in which the fluid flow is conveyed via the first treatment fluid flow path from the first mixing point (31) into the second compartment (4) of the blood treatment unit (1), in particular the dialyzer, through the semipermeable membrane into the first compartment (3) of the blood treatment unit (1), a control and computing unit (26) for controlling the blood treatment device and a user interface (46) cooperating with the control and computing unit (26) are provided, a substance concentration measuring unit (44) cooperating with the control and computing unit (46) is provided for detecting a measured value correlating with the concentration of a substance amount, in particular bicarbonate concentration, in the treatment liquid, and the control and computing unit (26) is configured such that the volume flow of the first concentrate pump (42) is set in the treatment mode such that the treatment liquid has a predetermined substance concentration, in particular bicarbonate concentration, and at least one parameter characteristic of the efficiency of the dialysis treatment is determined, an alarm control signal is generated if the predetermined substance concentration, in particular bicarbonate concentration, is not reached in the treatment mode, characterized in that the control and computing unit (26) is configured such thatthat after generating the alarm control signal, a check routine is started with which at least one parameter characteristic of the efficiency of the dialysis treatment is compared with a predetermined target value, wherein a reinfusion control signal is generated for the user interface (46) if the parameter is greater than or equal to the target value, and the user interface (46) is configured such that after receiving the reinfusion control signal, an optical and / or, acoustic and / or tactile signal is generated as a request to the user to initiate the reinfusion mode using the first container (34).

2. Blood treatment device, in particular a dialysis device, for extracorporeal blood treatment for use with a blood treatment unit (1), in particular a dialyzer, which is divided by a semipermeable membrane (2) into a first compartment (3), which is part of an extracorporeal blood circuit (I) of the blood treatment device, which comprises an arterial blood line (5) leading to an inlet (3A) of the first compartment (3) and a venous blood line (6) leading from an outlet (3B) of the first compartment (3), and a second compartment (4), which is part of a fluid system (II) of the blood treatment device, wherein the fluid system (II) of the blood treatment device comprises: a first connection unit (32) for connecting a first container (34) intended for single use, which is filled with a predetermined amount of a powdered first concentrate, in particular bicarbonate,for producing a liquid first concentrate, in particular liquid bicarbonate concentrate, by mixing permeate and powdered first concentrate in the container, a first mixing point (31) for mixing permeate and liquid first concentrate, in particular liquid bicarbonate concentrate, for producing the treatment liquid, in particular dialysis liquid, a liquid concentrate flow path which is designed such that the liquid first concentrate, in particular liquid bicarbonate concentrate, from the first connection unit (32) to the first, Mixing point (31), wherein a first concentrate pump (42) is provided in the liquid concentrate flow path, a first treatment liquid flow path which is designed such that the treatment liquid, in particular dialysis liquid, flows from the first mixing point (31) into the second compartment (4A) of the blood treatment unit (4), in particular the dialyzer, a second treatment liquid flow path which is designed such that the treatment liquid, in particular dialysis liquid, flows from the first mixing point (31) through the arterial blood line (5) into the first compartment (3) of the blood treatment unit (1), in particular the dialyzer, wherein a treatment liquid conveying device is provided for conveying the treatment liquid at a predetermined volume flow in the first and second treatment liquid flow paths, the blood treatment device provides a treatment mode,in which the treatment fluid, in particular dialysis fluid, is conveyed by the treatment fluid conveying device via the first treatment fluid flow path from the first mixing point (31) into the second compartment (4) of the blood treatment unit (1), in particular the dialyzer, and which, Blood treatment device provides a reinfusion mode in which the fluid flow through the first treatment fluid flow path is interrupted and treatment fluid, in particular dialysis fluid, is conveyed by the treatment fluid conveying device via the second treatment fluid flow path from the first Mixing point (31) through the arterial blood line (5) into the first compartment (3) of the blood treatment unit (1), a control and computing unit (26) for controlling the blood treatment device and a user interface (46) cooperating with the control and computing unit (26) are provided, a substance quantity concentration measuring unit (44) cooperating with the control and computing unit (46) is provided for detecting a measured value correlating with the concentration of a substance quantity, in particular bicarbonate concentration, in the treatment liquid, and the control and computing unit (26) is configured such that the volume flow of the first concentrate pump (42) is set in the treatment mode such that the Treatment fluid has a predetermined molar concentration, in particular bicarbonate concentration, and at least one parameter characteristic of the efficiency of the dialysis treatment is determined, an alarm control signal is generated if the predetermined molar concentration, in particular bicarbonate concentration, is not reached in the treatment mode, characterized in that the control and computing unit (26) is configured such that after the alarm control signal has been generated, a checking routine is started with which at least one parameter characteristic of the efficiency of the dialysis treatment is compared with a predetermined target value wherein a reinfusion control signal is generated for the user interface (46) when the characteristic is greater than or equal to the target value, and the user interface (46) is configured such that, upon receipt of the reinfusion control signal, an optical and / or acoustic and / or tactile signal is generated as a prompt to the user to initiate the reinfusion mode using the first container (34).

3. Blood treatment device according to claim 1 or 2, characterized in that the control and computing unit (26) is configured such that the control and computing unit determines the volume of treatment fluid actually consumed in the treatment mode as a characteristic parameter for the efficiency of the dialysis treatment, the control and computing unit reads the expected volume of treatment fluid, in particular dialysis fluid, to be produced using the first container (34) from a memory (26A), and compares the volume of treatment fluid actually consumed at the time of generation of the alarm control signal with the expected volume of treatment fluid, whereby the reinfusion control signal for the user interface (46) is generated,if the volume of treatment fluid actually consumed at the time the alarm control signal is generated is equal to or greater than the expected volume of, treatment fluid.

4. Blood treatment device according to one of claims 1 to 3, characterized in that the control and computing unit (26) is configured such that the control and computing unit determines the dialysis dose achieved in the treatment mode as a parameter characteristic of the efficiency of the dialysis treatment, the control and computing unit reads a predetermined minimum dialysis dose from a memory (26A), and compares the dialysis dose achieved in the treatment mode at the time of generation of the alarm control signal with the minimum dialysis dose, wherein the reinfusion control signal for the user interface (46) is generated if the dialysis dose achieved in the treatment mode at the time of generation of the alarm control signal is greater than or equal to the minimum dialysis dose.

5. Blood treatment device according to one of claims 1 to 4, characterized in that the control and computing unit (26) is configured such that the control and computing unit determines the elapsed treatment time as a characteristic parameter for the efficiency of the dialysis treatment, the control and computing unit reads a predetermined minimum treatment time from a memory, and compares the treatment time elapsed at the time of generation of the alarm control signal with the minimum treatment time, wherein the reinfusion control signal for the user interface (46) is generated if the treatment time elapsed at the time of generation of the alarm control signal is greater than or equal to the minimum treatment time.

6. Blood treatment device according to one of claims 1 to 5, characterized in that the control and computing unit (26) for the reinfusion mode using the first container (34) is configured such that in the reinfusion mode a first molar concentration, in particular bicarbonate concentration, is set in the treatment fluid, in particular dialysis fluid, which is smaller than the molar concentration, in particular bicarbonate concentration, set in the treatment fluid in the treatment mode.

7. Blood treatment device according to one of claims 1 to 6, characterized in that the control and computing unit (26) for the reinfusion mode using the first container (34) is configured such that in the reinfusion mode the volume flow of the treatment liquid conveying device is set to a predetermined value which is smaller than the volume flow of the treatment liquid set by the control and computing unit in the treatment mode.

8. Blood treatment device according to one of claims 1 to 7, characterized in that the blood treatment device comprises a balancing device (28) which divides at least one balancing chamber (9, 10) into two balancing chamber halves (9A, 9B; 10A, 10B). for balancing fresh and used dialysis fluid.

9. Blood treatment device according to one of claims 1 to 8, characterized in that the liquid system (II) of the blood treatment device comprises a second connection unit (33) for connecting a second container (43) filled with a predetermined amount of a second concentrate, in particular acetate or citrate, and comprises a second concentrate flow path designed such that the liquid second concentrate, in particular liquid acetate concentrate, flows from the second connection unit (33) to a second mixing point (41), wherein a second concentrate pump (43) is provided in the second concentrate flow path, wherein the control and computing unit (26) is configured such that the volume flow of the second concentrate pump is set in the treatment mode such that the treatment liquid has a predetermined second molar concentration, in particular acetate concentration or citrate concentration.

10. Blood treatment device according to claim 9, characterized in that the control and computing unit (26) for the reinfusion mode using the first container (34) is configured such that in the reinfusion mode a second molar concentration, in particular acetate concentration or citrate concentration, is set in the treatment liquid, which is equal to the second molar concentration, in particular acetate concentration or citrate concentration, set in the treatment liquid in the treatment mode.

11. Method for operating a blood treatment device, in particular a dialysis device, using a blood treatment unit, in particular a dialyzer, which is connected through a semipermeable membrane into a a first compartment which is part of an extracorporeal blood circuit of the blood treatment device, which comprises an arterial blood line leading to an inlet of the first compartment and a venous blood line leading from an outlet of the first compartment, and a second compartment which is part of a fluid system of the blood treatment device, wherein the fluid system of the blood treatment device comprises: a first connection unit for connecting a single-use first container which is filled with a predetermined amount of a powdered first concentrate, in particular bicarbonate, for producing a liquid first concentrate, in particular liquid bicarbonate concentrate, by mixing permeate and powdered first concentrate in the container, a first mixing point for mixing permeate and liquid first concentrate, in particular liquid bicarbonate concentrate,for producing the treatment fluid, in particular dialysis fluid, a liquid concentrate flow path which is designed such that the liquid first concentrate, in particular liquid bicarbonate concentrate, flows from the connection unit to the first mixing point, wherein a first concentrate pump is provided in the liquid concentrate flow path, the blood treatment device provides a treatment mode in which treatment fluid flows through the second compartment of the blood treatment unit and optionally from the blood treatment unit (1) into a further part of the fluid system (II) of the blood treatment device (1), and provides a reinfusion mode in which treatment fluid flows through the arterial blood line or, flows through the semipermeable membrane into the first compartment of the blood treatment unit, the volume flow of the first concentrate pump is adjusted in the treatment mode such that the treatment fluid has a predetermined molar concentration, in particular bicarbonate concentration, in the treatment mode at least one parameter characteristic of the efficiency of the dialysis treatment is determined, characterized in that a check routine is started in which the at least one parameter characteristic of the efficiency of the dialysis treatment is compared with a predetermined target value if the predetermined molar concentration, in particular bicarbonate concentration, is not reached in the treatment mode, and an optical and / or acoustic and / or tactile reinfusion signal is generated as a request to the user to initiate the reinfusion mode,if the parameter characteristic of the efficiency of the dialysis treatment is greater than or equal to the target value, and after the generation of an optical and / or acoustic and / or tactile reinfusion signal, the blood treatment device is operated in the reinfusion mode using the first container.

12. A method for operating a blood treatment device according to claim 11, characterized in that the volume of the blood actually consumed in the treatment mode Treatment fluid is determined as a parameter characteristic of the efficiency of the dialysis treatment, the expected volume of the treatment fluid, in particular dialysis fluid, to be produced using the first container is read out from a memory, and the actually used volume of the treatment fluid is compared with the expected volume of the treatment fluid, wherein the optical and / or acoustic and / or tactile reinfusion signal is generated as a request to the user to initiate the reinfusion mode when the volume of the actually used treatment fluid is equal to or greater than the expected volume of the treatment fluid.

13. Method for operating a blood treatment device according to claim 11 or 12, characterized in that the dialysis dose achieved in the treatment mode is determined as a parameter characteristic of the efficiency of the dialysis treatment, a predetermined minimum dialysis dose is read from a memory, and the dialysis dose achieved in the treatment mode is compared with the minimum dialysis dose, wherein the optical and / or acoustic and / or tactile reinfusion Signal is generated as a request to the user to initiate the reinfusion mode when the treatment mode achieved dialysis dose is greater than or equal to the minimum dialysis dose.

14. A method for operating a blood treatment device according to one of claims 11 to 13, characterized in that the elapsed treatment time is determined as a parameter characteristic of the efficiency of the dialysis treatment, a predetermined minimum treatment time is read from a memory, and the treatment time elapsed in the treatment mode is compared with the minimum treatment time, wherein the optical and / or acoustic and / or tactile reinfusion signal is generated as a request to the user to initiate the reinfusion mode if the treatment time elapsed in the treatment mode is greater than or equal to the minimum treatment time.

15. Method according to one of claims 11 to 14, characterized in that a first molar concentration, in particular bicarbonate concentration, is set in the treatment liquid which is smaller than the molar concentration, in particular bicarbonate concentration, set in the treatment liquid in the treatment mode.

16. Method according to one of claims 11 to 15, characterized in that the volume flow of the treatment fluid, in particular dialysis fluid, in the reinfusion mode is set to a predetermined value which is smaller than the volume flow of the Treatment fluid is in treatment mode.

17. The method according to any one of claims 11 to 16, characterized in that the liquid system of the blood treatment device comprises a second connection unit for connecting a second container which is filled with a predetermined amount of a second concentrate, in particular acetate or citrate, and a second mixing point for mixing the liquid first concentrate and the liquid second concentrate, in particular liquid acetate concentrate, wherein in the reinfusion mode a second molar concentration, in particular acetate concentration, is set in the treatment liquid which is equal to the second molar concentration, in particular acetate concentration or citrate concentration, set in the treatment mode in the treatment liquid.

Images