Apparatus and procedure for preparing dialysate

Abstract

The present invention relates to a device for producing a medical solution, preferably a concentrated dialysis solution, comprising a fluid system with a main circuit and a branched section connected thereto. The main circuit contains a pump and a product container, and the liquid circulates within it via the pump. A raw material container can be attached to the branched section. This branched section includes a suction line extending from the attachable raw material container to a suction unit in the main circuit. The suction unit is designed to draw the liquid, along with the undissolved raw material, from the suction line and introduce it into the liquid flowing through the main circuit.In addition, the main circuit includes a fine mixing chamber located between the suction unit and the product container. This fine mixing chamber has two connectors and a retention element, positioned between the connectors, for the undissolved raw material.

Description

[0001] The invention relates to a device and a method for producing a medical solution and preferably a dialysis concentrate solution.

[0002] Several methods for producing dialysis concentrate solutions from undissolved or partially dissolved raw materials are known in the prior art. For example, it is known to dissolve raw materials in a mixing vessel using a stirrer in a solvent, typically RO water, which is also referred to as permeate or dialysis water. Another known method is the cyclical flushing and extraction of solvent directly into and out of a raw material container via a single connection. However, this process is relatively time-consuming and the degree of dissolution is difficult to control. For example, publication GB2097285A discloses a device and a method for producing dialysate. DE10 2012 004886 discloses an at least partially automated method for producing dialysate. It is also known to circulate a solvent through a raw material container.The raw material container can, for example, have two connections and allow flow from top to bottom or vice versa. Typically, liquid is continuously flushed into the raw material container from the top or bottom and drawn off from the top or bottom. In such a process, however, some of the raw material will enter the product container unless this is prevented by separate measures. If undissolved raw material enters the product container, there is a risk that it will remain undissolved and the composition of the finished solution will be incorrect, i.e., it will not meet the specifications. Furthermore, in these known processes, the raw material container must be designed as a pressure vessel, as the build-up of overpressure within the raw material container cannot be prevented.

[0003] The object of the invention is to provide a device and a method for producing a medical solution and preferably a dialysis concentrate solution, which makes it possible to mix raw materials of different consistencies housed in any raw material containers with a solvent with high mixing reliability.

[0004] This problem is solved according to the invention by a device for producing a medical solution and preferably a dialysis concentrate solution, which has a fluid system with a main circuit and a branch section connected thereto, wherein the main circuit is a circuit in which a pump and a product container are arranged and in which liquid can be circulated by operating the pump, wherein a raw material container can be connected in the branch section, wherein the branch section comprises a suction line that leads from the raw material container to be connected to a suction unit of the main circuit, and wherein the suction unit is designed to draw liquid together with undissolved raw material from the suction line and introduce it into a liquid flowing through the main circuit, wherein a fine mixing chamber is further arranged in the main circuit between the suction unit and the product container.which has two connections and a retention element arranged between the connections for undissolved raw material.

[0005] The device is particularly suitable for the production of dialysis concentrate solutions, but is also fundamentally suitable for the production of other medical solutions where specific quantities of raw materials are to be dissolved or mixed with a specific quantity of a solvent. The resulting solution can be a ready-to-use solution or a concentrate such as a dialysis concentrate, which must be diluted again in a further step to obtain a ready-to-use solution.

[0006] When solvent or the resulting solution is circulated in the main circuit of the fluid system by the operation of the pump, the liquid passes through the product container and the suction unit. The suction unit is preferably located in the main circuit between the pressure side of the pump and the product container. Because the suction unit is designed such that liquid, along with undissolved raw material, is drawn from the connected raw material container into the main circuit via the suction line, the pressure in the suction line is lower during operation than in the section of the main circuit containing the suction unit. Therefore, the raw material container connected via the suction line does not need to be a pressure vessel; bags or similar containers can also be used.Furthermore, even if the raw material container has a rigid wall, it does not have to be pressure-tight from the environment, but may have openings for ventilation, which may be closable.

[0007] In one embodiment, the retention element comprises a filter element that retains the undissolved raw material. The filter element can be arranged such that the liquid containing the undissolved raw material must flow against gravity to pass through it. Additionally, the fine mixing chamber can include a turbulence chamber that the liquid reaches before the filter element and that extends around the filter element, so that the resulting overflow of liquid can aid in the dissolution of the undissolved raw material.

[0008] Preferably, the fine mixing chamber is arranged in the main circuit so that the flow passes through it from bottom to top. By positioning the fine mixing chamber in the direction of flow between the intake unit and the product container, raw materials from the raw material container do not enter the product container via the suction line without first passing through the fine mixing chamber. This ensures thorough mixing and prevents undissolved raw material from entering the product container.

[0009] In one embodiment, at least two such fine mixing chambers are provided, connected in series or parallel, with their retention elements having different characteristics and preferably particle permeabilities. For example, the retention capacity of the fine mixing chamber downstream in the flow direction can be finer than that of the fine mixing chamber upstream in the flow direction. This arrangement ensures optimal resolution and prevents potential blockages in the circuit. Generally, a combination of several fine mixing chambers connected in parallel and / or series with identical or different retention capacities is possible to optimize the mixing process.

[0010] In one embodiment, the main circuit and the branch section are designed such that a connected raw material container can first be filled with liquid via the suction line and the intake unit, against the direction of suction, before the mixing process begins. This process can also be repeated as needed, e.g., controlled by time, fill quantity, or pressure. This makes it possible to use solid or gelatinous raw materials that cannot be drawn in as such. The liquid introduced into the raw material container serves as a carrier fluid in which, for example, solid raw materials can be dispersed. The raw material-containing liquid is then transported away through the suction line.

[0011] In one embodiment, the suction unit is a Venturi nozzle, with the suction line opening into a constriction in the main circuit line. In this embodiment, liquid, along with undissolved raw material, can be drawn from the suction line and thus from the connected raw material container into the liquid circulating in the main circuit via Venturi injection and carried along by it. Before mixing, the raw material container can be filled through the Venturi nozzle by means of a pressure build-up in the main circuit, using a closed control valve, via the suction line against the suction direction.

[0012] In one embodiment, the branch section further comprises a flushing line that branches off from the main circuit between the pressure side of the pump and the suction unit and can be connected to the feedstock container. In this embodiment, the branch section forms a closed bypass to the main circuit, which runs through the connected feedstock container. This allows solvent or the resulting dialysis concentrate solution to be mixed from the main circuit into the connected feedstock container to flush it. The flushing line can also be used, in particular, to clean the feedstock container after use.

[0013] For example, the raw material container can be a reusable container, which may or may not be designed as a pressure vessel. This container can be filled via a filling port with any raw material as the starting material for the solution or dialysis solution concentrate to be produced. The raw material can be in solid form, e.g., as a powder or granules, as a solid / liquid mixture, or as a slurry, and must contain at least some undissolved components. Alternatively, the raw material container can be a foil bag.

[0014] The device according to the invention is also suitable for use with raw material containers that contain only liquid components. No special adaptation of the device is required in such a case.

[0015] In one embodiment, it is possible to short-circuit the flushing line and the suction line at a coupling point, so that the lines can be flushed after disconnecting the raw material container, for example to introduce any remaining concentrate into the main circuit or for cleaning purposes after completion of the solution production.

[0016] In one embodiment, at least one further branch section is provided, to which another raw material container can be connected and which includes a further suction line leading from the connected raw material container to a suction unit of the main circuit. The further suction line is preferably arranged parallel to the first suction line and opens into the same suction unit of the main circuit. However, several suction units can also be provided in the main circuit. In this embodiment, it is possible to connect several different raw material containers to the system, containing different raw materials in, for example, different states of matter. If several branch sections are provided, they can be identical or different. The above descriptions of preferred configurations of the first branch section apply accordingly to each further branch section.

[0017] In one embodiment, the fluid system has a supply line that connects to the main circuit. For example, the fluid system can be connected to a reverse osmosis (RO) water source via the supply line. Preferably, the supply line connects to the main circuit between the product container and the suction side of the pump.

[0018] In one embodiment, the fluid system includes a product line branching off from the main circuit. For example, dialysis machines or solution containers, e.g., for storage, can be connected to the device via this product line. Preferably, the product line branches off from the main circuit between the pressure side of the pump and the suction unit. The product line can also branch off from the flushing line of the branch section.

[0019] In a further embodiment, the fluid system includes a heater to warm the liquid or solution contained therein. The heater is preferably arranged in the main circuit and can, for example, be located between the pressure side of the pump and the suction unit.

[0020] The fluid system preferably comprises several valves with which the flow through the different lines of the system can be controlled. For example, control valves can be arranged in the main circuit between the suction unit and the product container and / or in the rinsing line. A control valve can preferably be provided in the suction line near the suction unit. Control valves can be arranged in the supply line and / or the product line.

[0021] The problem initially posed is also solved by systems consisting of an inventive device for producing a medical solution, preferably a dialysis concentrate solution, and of one or - if provided - several connected raw material containers.

[0022] Against the background mentioned above, the invention further relates to a method for producing a medical solution, and preferably a dialysis concentrate solution, using a device according to the invention, wherein the solvent or resulting solution is circulated in the main circuit by operating the pump, and simultaneously raw materials are drawn from the suction line by the suction unit and introduced into the liquid circulating in the main circuit. The drawn-in raw materials are liquid raw materials or raw materials dissolved or dispersed in a carrier liquid.

[0023] In one embodiment, the solvent or resulting solution from the main circuit is introduced into the raw material container via the dilution line, mixed with the raw materials, and then drawn through the suction line together with the raw materials. The solvent or resulting solution from the main circuit is thus used as a carrier fluid for the raw material. This can occur once at the beginning of the manufacturing process, or repeatedly or continuously during the manufacturing process.

[0024] The process can be carried out automatically or semi-automatically by a control unit present in mixing devices, which is configured accordingly to control the necessary actuators such as pumps and valves and to read the necessary measured values ​​from sensors.

[0025] Against the background mentioned above, the invention further relates to the use of a device according to the invention for the production of a medical solution and preferably a dialysis concentrate solution.

[0026] Advantages of the invention include the possibility of an at least semi-automatic mixing process for the complete dissolution of any raw material. Due to the fine mixing chamber with a retention element for undissolved raw materials, complete dissolution of the raw material can be ensured. Raw material contamination of the product container is prevented. In some embodiments, the mixing process is self-regulating, as will be explained below. It is possible to connect any raw material container, such as flexible disposable bags and rigid reusable containers, as the raw material source. The consistency of the raw material can be selected as desired. Processing of solid raw materials is just as possible as processing of gelatinous or liquid raw materials.

[0027] Further details and advantages of the invention will become apparent from the exemplary embodiments described below with reference to the figures. The figures show: Figure 1: a flow diagram of an embodiment of a system of a device according to the invention for producing a dialysis concentrate solution with an attached raw material container; Figure 2: a section through an embodiment of a fine mixing chamber with a retention element designed as a filter element; Figure 3: a flow diagram of an embodiment of a further system of a device according to the invention for producing a dialysis concentrate solution with an attached raw material container designed as a disposable bag; and Figure 4: a flow diagram of an embodiment of yet another system of a device according to the invention for producing a dialysis concentrate solution with two attached raw material containers.

[0028] The in Figure 1The illustrated embodiment of a device according to the invention comprises a supply connection 1 for solvents with a supply line 3 in which a supply valve 2 is arranged. The supply line 3 opens into a main circuit 5 in which, among other things, a pump 7, a first control valve 22 and a product container 27 are arranged.

[0029] In a first preparatory step for the production of a dialysis concentrate solution, RO water is filled into the product container 27 through the supply line 3 with valve 2 open, using the boost pressure applied to the supply port 1. The quantity of liquid flowing into the product container 27, or its fill level, can be determined using the flow meter 4 or the level sensors 30 and 35. A gravimetric sensor (not shown in the figure) can also be provided to determine the fill level in the product container 27. After completion of this preparatory step, the supply valve 3 can be closed.

[0030] The device further comprises a branch section 10, which is connected to the main circuit 5. The branch section 10 branches off from the main circuit 5 at a junction point 8 on the pressure side of the pump 7 and comprises a flushing line 11, a second control valve 23, and a suction line 16, which includes a further control valve 38. The suction line 16 and the flushing line 11 can be connected to a raw material container 18.

[0031] The suction line 16 opens into the main circuit 5 at an intake unit 15 designed as a Venturi nozzle. The raw material container 18 is, in the embodiment according to Figure 1a rigid and reusable container with a connection 19 for the flushing line 11, a connection 14 for the suction line 16 and a filling connection 17 for filling and, if necessary, emptying the raw material container 18. Furthermore, a level sensor 56 is provided for determining the fill level in the raw material container 18, in particular to prevent the raw material container 18 from overflowing.

[0032] In a second preparatory step for the production of a dialysis concentrate solution, the raw material container 18 is connected to the device. If the raw material container is not already filled with raw material, it can be filled with a specific quantity of raw material via the filling port 17. This raw material can be a solid, for example, a powder or granules, or a viscous, for example, sludge, or a low-viscosity concentrate. (Re)filling can take place with the raw material container connected or disconnected.

[0033] When using solid raw materials or viscous concentrates, a third preparation step may involve pumping a portion of the solvent from the product container 27 through the suction line 16 into the raw material container 18, using pump 7, with valve 38_1 open and control valve 22 closed. This portion is vented to the environment by an aeration device (not shown). This portion of the solvent serves as a transport medium for, for example, the solid raw material, which, although barely dissolved at this stage, is at least dispersed and thus made permeable to the flow.

[0034] The order of the preparation steps is essentially arbitrary, with the sole restriction that the product container 27 must be filled with solvent before a portion of the solvent it contains is pumped into the raw material container 18. For example, it may be possible to fill the raw material container 18 with raw material only after it has been partially filled with solvent. Alternatively, the raw material container 18 can be filled with raw material before the product container 27 is filled with solvent.

[0035] At the start of the mixing process, solvent from the product container 27 is circulated in the main circuit 5 by means of the pump 7 with the first control valve 22 open. At the intake unit 15, liquid or liquid-dispersed, undissolved raw material from the connected raw material container 18 is drawn through the suction line 16 into the solvent circulating in the main circuit 5 and carried along by Venturi injection. Downstream of the intake unit 15, fine mixing chambers 48_1 and 48_2 are arranged in series in the main circuit 5. In the fine mixing chambers 48_1 and 48_2, the undissolved raw material is dissolved in the solvent. Each fine mixing chamber 48_1 and 48_2 includes a retention element for the undissolved components of the raw material. The presence of two fine mixing chambers 48_1 and 48_2 serves to optimize the device according to the invention.The principle of the invention requires only the presence of at least one fine mixing chamber 48_1.

[0036] Figure 2 Figure 1 shows an embodiment of such a fine mixing chamber 48_1 or 48_2, in which the retention element is designed as a filter element. The liquid, containing the at least partially undissolved concentrate raw material, flows into the fine mixing chamber housing 104 laterally and preferably with a lateral offset through the inlet 101 of the fine mixing chamber and enters a swirl chamber 107, which extends around the filter element 106. Alternatively, the fine mixing chamber inlet can also be located at the bottom (102) instead of laterally on the fine mixing chamber housing 104.

[0037] The inflow of the suspension from the side or from below creates a vortex in the swirl chamber 107 within the fine mixing chamber housing 104. To reach the filter element 106, the liquid containing the undissolved raw material must flow upwards through the swirl chamber 107 against gravity. Undissolved components are preferentially retained in the swirl chamber 107 by both the vortex and gravity, where their dissolution is accelerated by the vortex. Undissolved components that nevertheless reach the filter element 106 are retained by the filter element 106 and dissolved by the overflowing liquid. The liquid or solution flowing through the filter element 106 is collected in the collecting pipe 105 and flows via the outlet 103 of the fine mixing chamber 48_1 into the mixing line of the mixing plant, either to a further fine mixing chamber 48_2 (as in Figure 1shown) or directed directly back into product container 27.

[0038] The filter element of the second fine mixing chamber 48_2 can have a finer particle permeability than the filter element of the first fine mixing chamber 48_1, i.e. the retention capacity of the first fine mixing chamber can be smaller than that of the second fine mixing chamber 48_2, in order to promote a stepwise dissolution of the raw material.

[0039] The liquid exiting the fine mixing chambers 48_1 and 48_2 flows back into the product container 27. The filters of the fine mixing chambers 48_1 and 48_2 allow liquid to pass through according to their retention capacity and retain any undissolved raw material particles to the required extent. This prevents raw material particles from entering the product container 27.

[0040] To accelerate and optimize the dissolving process, the solvent can be heated before and during the dissolving process. For this purpose, a flow heater 9 and a temperature sensor 29 are arranged in the main circuit 5 upstream of the intake unit 15 and the fine mixing chambers 48_1 and 48_2.

[0041] In the suction line 16, shortly before it enters the suction unit 15, a control valve 38_1 and a sensor 39, which can be configured as a pressure sensor, are arranged. The sensor 39 serves to monitor the mixing process and to detect the fill level of a connected raw material container 18. The control valve 38_1 can interrupt the suction line 16 if necessary, e.g., if the raw material container 18 is empty and the intake of air is to be prevented.

[0042] The solvent, or the resulting dialysis concentrate solution, is circulated in the main circuit 5 until all the raw material in the connected raw material container 18 has dissolved. During the dissolution process, it may be necessary to perform an intermediate step several times, corresponding to the third preparation step described above. This step involves using pump 7, with the control valves 22 and 38_1 appropriately positioned, to pump a portion of the solvent from the product container 27 through the suction line 16 of the branch section 10 into the connected raw material container 18 to make further portions of the raw material, for example, solid, passable. The complete consumption of the raw material can be monitored using a timer and / or sensor 39. Furthermore, a gravimetric or other suitable sensor can be installed on the raw material container 18.

[0043] Once all the raw material in the raw material container 18 has been consumed and the raw material container 18 has been emptied by the suction unit 15, the dissolution process and the circulation of the now finished dialysis concentrate solution in the main circuit 5 can be stopped, or the solution can be circulated for a certain period of time beforehand to dissolve any remaining undissolved raw material in the fine mixing chambers. Optionally, the device can include sensors for automatic quality control of the dialysis concentrate solution, such as density sensors, conductivity sensors, or refractometers.

[0044] The retention of undissolved raw material particles in a fine mixing chamber 48_1 or 48_2 is a significant advantage of the solution according to the invention. In static mixers, such as those often used in the prior art, the raw material is dissolved by turbulence with the solvent, and the mixture is then pumped into a product container. Undissolved raw material also enters the product container. Within the framework of the manufacturing process or the device according to the invention, no dissolution of raw material occurs in the product container 27, since the undissolved raw material does not even enter the product container 27 due to the fine mixing chamber.

[0045] If the retention element in the fine mixing chamber 48_1 or 48_2 is designed as a filter element, the system, including the intake unit 15, can operate self-regulatingly without any additional aids. If undissolved raw material reduces the flow through the filter element, the flow through the intake unit, designed as a Venturi nozzle in this embodiment, decreases. This results in less undissolved raw material being drawn in and introduced into the fine mixing chamber until the clogging raw material components are dissolved by the overflowing liquid, reducing or even eliminating the blockage, thereby increasing the flow rate again. This self-regulation promotes the dissolution of the raw material and simultaneously prevents significant clogging of the retention element and thus of the liquid flow containing the raw material.

[0046] The finished dialysis concentrate solution can be pumped by means of pump 7 through a product line with a filter 12 and a transfer valve 13 to different receiving stations T1a-T3b such as dialysis machines or solution containers, e.g. for storage.

[0047] After completion of the process, the system and all flow paths can be flushed and, if necessary, disinfected. For this purpose, cleaning fluid, for example, RO water or RO water containing peroxides (which, for example, was metered from supply port 1 into container 27 or treated with peroxides), can be pumped through the system's pipes using pump 7. The cleaning process can include an attached raw material container 18 before it is refilled with raw material at the same or a separate location, or disposed of after cleaning. Alternatively, the device can be configured to produce the cleaning fluid itself, as in the case of the medical solution, using a raw material container 18 filled with a disinfectant or disinfectant solution.

[0048] For cleaning purposes, a spray head 51 connected to the rinsing line 11 is provided in the raw material container 18. A spray head 26 is also provided in the product container 27, which is connected to a cleaning line 25 with a cleaning valve 24. The cleaning line 25 branches off from the rinsing line 11 of the branch section 10. Thus, the raw material container 18 and the product container 27 can be rinsed by pumping cleaning fluid from the pump 7 into the rinsing line 11 with the supply valve 2 open and the first control valve 22 closed. From there, depending on the position of the second control valve 23 and the cleaning valve 24, the fluid flows into the spray head 51 of the raw material container 18 and / or the spray head 26 of the product container 27 and is sprayed into the respective container. It is also possible for the cleaning fluid to be metered into the container 27 via the supply connection 1 before being circulated by the pump 7.The main mixing paths can be cleaned by opening the first control valve 22 and closing control valves 23 and 24. If flow conditions permit, control valves 22, 23, and 24 can also be open simultaneously during the cleaning process. Used cleaning solution can be discarded through drain 6.

[0049] Figure 3 shows a flowchart of a further embodiment of a device according to the invention for producing a dialysis concentrate solution. The flowchart is basically the same as that of the Figure 1 similar, and only the differences will be discussed below.

[0050] In contrast to the device of Figure 1 is in the device of the Figure 3 No rigid and reusable container was used as the raw material container, but rather a flexible disposable bag 18.

[0051] The disposable bag 18 has an optional connection 19 for the line 11, which may serve for venting, and a connection 14 for the suction line 16 of the branch section 10. The connections between the optional connection 19 and the line 11 on the one hand, and the connection 14 and the suction line 16 on the other, are detachable. For example, the corresponding connections can be equipped with quick-release couplings. On the machine side, near the connection point of the disposable bag 18, there is a coupling point 21 to which both the end of the line 11, which can be connected to the optional connection 19, and the end of the suction line 16, which can be connected to the connection 14, can be connected. The coupling point 21 has a section of pipe with two connectors, for example, quick-release couplings.

[0052] The end of line 11 is connected to coupling point 21 or, in the case of an optional connection 19, alternatively to connection 19. The end of suction line 16 can optionally be connected to connection 14 or to coupling point 21. If both ends are connected to the coupling point, a closed circuit is formed, excluding the bag 18. This configuration should be in place during system cleaning and generally whenever no bag is connected. Connecting the end of suction line 16 to connection 14 replaces the second connection in connection with Figure 1 described preparation step. This configuration is in Figure 3 shown.

[0053] A connection of the end of line 11 to connection 19 can be made in connection with the third in relation to Figure 1The described preparation step can be carried out if ventilation of the bag is desired during potential filling via the suction line 16. However, especially with disposable bags, it may also be the case that the bag 18 is already sufficiently filled with liquid by the manufacturer to flush out the undissolved raw materials, so that a filling process with liquid is unnecessary or partially unnecessary.

[0054] Subsequently, the medical solution and preferably the dialysis concentrate solution are mixed and prepared as already explained.

[0055] In this embodiment, the dissolution process can be terminated after all the raw material-containing liquid in bag 18 has been sucked out and any remaining raw material quantities in the fine mixing chambers have been dissolved.

[0056] For subsequent cleaning, bag 18 is disconnected and suction line 16 and line 11 – if not already connected – are short-circuited via coupling point 21. To clean suction line 16 and lines 11 and 25, control valves 38_1 and 24 must be opened.

[0057] Naturally, a device according to the invention can be designed such that it uses both a rigid and reusable raw material container as in Figure 1 as well as a flexible disposable bag like in Figure 3 They can be connected. Alternative connections and / or slots may be provided for this purpose.

[0058] Figure 4 shows a flowchart of yet another embodiment of a device according to the invention. The flowchart essentially corresponds to a combination of the features described in the Figure 1 and 3 Examples of implementation shown.

[0059] In the device of the Figure 4A second suction line 20 with a second control valve 38_2 is provided, which runs parallel to the first suction line 16 and connects to the first suction line 16 at the measuring point of the sensor 39, between the control valve 38_1 and the suction unit 15, i.e., shortly before the suction unit 15. This second suction line 20 serves to connect a second raw material container 52 in the form of a disposable bag filled with a liquid. This bag 52 can contain a liquid concentrate or an active ingredient solution, which is to be introduced into the dialysis concentrate solution in addition to the raw material in the raw material container 18. For this purpose, the end of the second suction line 20 can be connected to the port 22 of the second raw material container 52. During circulation of the solvent or...The resulting dialysis concentrate solution in the main circuit 5 and flowing through the suction unit 15 then, by means of Venturi injection, not only raw material-containing liquid is drawn through the suction line 16, but also an additional raw material is drawn through the second suction line 20 (for example alternately or simultaneously) into the solvent circulating in the main circuit 5 and carried along.

[0060] In this embodiment, the dissolution process can be terminated after all the raw material-containing liquid in container 18 and all the additional ingredient in bag 52 have been sucked out and any remaining quantities of raw material remaining in the fine mixing chambers have been dissolved.

[0061] If no additional raw material container 52 is connected, for example, when not in use or when the circuit is being flushed, the end of the second suction line 20 can be connected to a coupling point 21 branching off from the flushing line 11, which includes a suitable connector, for example, a quick-release coupling. In the case of the exemplary embodiment of Figure 4 A venting option for the container 52 can also be provided via a connection as in the case of the embodiment described above. Figure 3 is planned, which is in Figure 4 not shown in more detail.

Claims

1. Apparatus for preparing a medical solution and preferably a dialysis concentrate solution, comprising a fluid system having a main circuit (5) and a branch section (10) in communication therewith, wherein the main circuit (5) is a circuit in which a pump (7) and a product container (27) are arranged and in which liquid can be circulated by operation of the pump (7), and wherein a raw material container having a raw material (18) that is at least partly not dissolved is connectable in the branch section (10), and wherein the branch section (10) comprises a suction line (16) that leads from the raw material container (18) to be connected to a suction unit (15) of the main circuit (5), wherein the suction unit (15) is configured to suck liquid together with raw material not yet dissolved out of the suction line (16) and to introduce it into a liquid flowing through the main circuit (5), characterized in that a fine mixing chamber (48_1, 48_2) having two connectors and a retention element for undissolved raw material arranged between the connectors is arranged in the main circuit (5) between the suction unit (15) and the product container (27), and the apparatus furthermore comprises a control unit that is configured to automatically or semi-automatically carry out a method for preparing a medical solution, wherein solvent or produced solution is circulated in the main circuit (5) by operation of the pump (7) and raw materials are simultaneously sucked out of the suction line (16) by the suction unit (15) and are introduced into the liquid circulating in the main circuit (5), and wherein the control unit is further configured to actuate the necessary actuators, in particular pumps and valves, and to read in the measurement values required therefor from sensors.

2. Apparatus according to claim 1, characterized in that the retention element comprises a filter element that retains the undissolved raw material.

3. Apparatus according to claim 2, characterized in that the filter element is arranged such that the liquid containing the undissolved raw material has to flow against gravity in order to pass through the filter element.

4. Apparatus according to claim 3, characterized in that the fine mixing chamber (48_1, 48_2) comprises a swirl chamber that the liquid reaches first before reaching the filter element and that extends around the filter element.

5. Apparatus according to one of the preceding claims, characterized in that at least two such fine mixing chambers (48_1, 48_2) are provided which are connected in series or in parallel and whose retention elements have different characteristics and preferably different particle permeabilities.

6. Apparatus according to one of the preceding claims, characterized in that the suction unit (15) is an active suction unit, in particular a pump, or a passive suction unit.

7. Apparatus according to one of the preceding claims, characterized in that the suction unit (15) is a Venturi nozzle, wherein the suction line (16) opens into a narrowing portion of the line of the main circuit (5).

8. Apparatus according to one of the preceding claims, characterized in that the branch section (10) furthermore comprises a flushing line (11) that branches off from the main circuit (5) between the pressure side of the pump (7) and the suction unit (15) and is connectable to the raw material container (18).

9. Apparatus according to one of the preceding claims, characterized in that at least one further branch section is present to which a further raw material container (52) is connectable and that comprises a further suction line (20) that leads from the further raw material container (52) to a suction unit (15) of the main circuit (5).

10. System comprising an apparatus according to one of the preceding claims and a connected raw material container (18).

11. System comprising an apparatus according to claim 9 or claim 10 with at least one further connected raw material container (52).

12. Method for preparing a medical solution and preferably a dialysis concentrate solution using an apparatus according to one of the preceding claims, characterized in that solvent or produced solution is circulated in the main circuit (5) by operation of the pump (7) and raw materials are simultaneously sucked out of the suction line (16) by the suction unit (15) and introduced into the liquid circulating in the main circuit (5), and the method is carried out automatically or semi-automatically by a control unit provided in a mixing apparatus, which control unit is configured to actuate the necessary actuators, in particular pumps and valves, and to read in the measurement values required therefor from sensors.

13. Method according to claim 12, characterized in that solvent or produced solution is introduced from the main circuit (5) via the dilution line (11) into the raw material container (18), mixed with the raw materials, and drawn through the suction line (16) together with the raw materials.

14. Method according to claim 12 or 13, characterized in that the preparation of the solution takes place in a self-regulating manner with the aid of the fine mixing chamber (48_1, 48_2) arranged in the main circuit and the retention element contained therein.

15. Use of a system according to claim 10 or 11 for preparing a medical solution and preferably a dialysis concentrate solution.

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