Medical fluid generating device

Abstract

A medical fluid generating device is provided with: a fluid circuit comprising a primary fluid line having an inlet for receiving water; a pump activated on the main fluid line to circulate the fluid; a plurality of valves on the fluid circuit, configurable to define different fluid paths for fluid inside the fluid circuit; a support structure having a first primary container inlet for communication with the primary concentrate container and a first secondary container inlet for fluid communication with the secondary concentrate container; the mixing container is provided with an inlet and an outlet. The fluid circuit includes: a medical fluid outlet disposed downstream of the pump; a mixing vessel outlet line connecting an outlet of the mixing vessel to a first junction on the main fluid line placed upstream of the pump; a mixing vessel inlet line connecting a sixth junction on the main fluid line downstream of the pump to an inlet of the mixing vessel; a primary concentrate container outlet line connecting the first primary container inlet to a fifth junction on the primary fluid line upstream of the pump; an auxiliary concentrate container outlet line connecting the first auxiliary container inlet to a third junction on the primary fluid line upstream of the pump.

Description

Technical Field

[0001] The present disclosure generally relates to a medical fluid generation device, particularly a medical fluid generation device for dialysis fluid treatment. More particularly, embodiments of the present disclosure relate to the batch preparation of medical fluids, such as dialysis fluids for peritoneal dialysis or hemodialysis. In another aspect, the present disclosure relates to a dry concentrate bag for medical fluid preparation. Background Art

[0002] A person's renal system may fail for various reasons. Renal failure gives rise to several physiological disorders. It is no longer possible to balance water and minerals or excrete the daily metabolic load. Toxic metabolic end products such as urea, creatinine, uric acid, etc. may accumulate in the patient's blood and tissues.

[0003] Dialysis is used to treat declining renal function, particularly renal failure. Dialysis removes waste products, toxins, and excess water from the body, which would otherwise be removed by a normally functioning kidney. Dialysis treatment for replacing renal function is critical for many people since the treatment is life-saving.

[0004] One type of renal failure treatment is hemodialysis ("HD"), which typically uses diffusion to remove waste products from the patient's blood. A diffusion gradient occurs across a semi-permeable dialyzer between the blood and an electrolyte solution called dialysate or dialysis fluid to effect diffusion. HD fluid is typically generated by a dialysis machine by mixing a concentrate and clean water.

[0005] Hemofiltration ("HF") is an alternative renal replacement therapy that relies on the convective transport of toxins from the patient's blood. HF is achieved by adding a replacement or substitution fluid to the extracorporeal circuit during treatment. During the HF treatment, the replacement fluid and the fluid accumulated by the patient between multiple treatments are ultrafiltered, thus providing a convective transport mechanism that is particularly beneficial in removing middle and large molecules.

[0006] Hemodiafiltration ("HDF") is a treatment modality that combines convective and diffusive clearance. HDF uses a dialysis fluid flowing through a dialyzer, similar to standard hemodialysis, to provide diffusive clearance. In addition, a replacement solution is directly delivered to the extracorporeal circuit to provide convective clearance. Here, more fluid is removed from the patient's body than the patient's excess fluid, thus causing an increased convective transport of waste products from the patient. The extra fluid removed is replaced by a replacement or substitution fluid.

[0007] Another type of treatment for kidney failure is peritoneal dialysis (“PD”), which infuses a dialysis solution (also known as dialysis fluid) into the patient's peritoneal cavity via a catheter. The dialysis fluid contacts the peritoneum located in the patient's peritoneal cavity. Waste products, toxins, and excess water pass from the patient's bloodstream through the capillaries in the peritoneum and enter the dialysis fluid due to diffusion and osmosis, i.e., there is an osmotic gradient across the membrane. Osmotic agents in the PD dialysis fluid provide the osmotic gradient. The used or waste dialysis fluid is drained from the patient's body, removing waste products, toxins, and excess water. This cycle is repeated, for example, multiple times. The PD fluid is typically prepared in a factory and delivered to the patient's home in ready-to-use bags.

[0008] There are various types of peritoneal dialysis treatments, including continuous ambulatory peritoneal dialysis (“CAPD”), automated peritoneal dialysis (“APD”), tidal dialysis, and continuous flow peritoneal dialysis (“CFPD”). CAPD is a manual dialysis procedure where fluid transport is driven by gravity. If the peritoneal cavity is initially filled with used dialysis fluid, the patient manually connects the implanted catheter to the drain to allow the used or waste dialysis fluid to drain from the patient's peritoneal cavity. Subsequently, the patient switches the fluid connection so that the patient catheter is connected to a bag of fresh dialysis fluid to allow the fresh dialysis fluid to pass through the catheter and infuse into the patient's body. The patient disconnects the catheter from the fresh dialysis fluid bag and allows the dialysis fluid to remain in the peritoneal cavity where the transfer of waste products, toxins, and excess water occurs. After the dwell period, the patient repeats the manual dialysis procedure, e.g., four times a day. If the peritoneal cavity is not initially filled with used dialysis fluid, the sequence is changed to fill, dwell, and drain. Manual peritoneal dialysis requires a significant amount of time and effort from the patient, leaving room for improvement.

[0009] Automated peritoneal dialysis (“APD”) is similar to CAPD in that the dialysis procedure includes drain, fill, and dwell cycles. However, the APD machine typically performs the cycles automatically while the patient is sleeping. The APD machine spares the patient from having to manually perform the treatment cycles and from having to make deliveries during the day. The APD machine is fluidly connected to the implanted catheter, a source or bag of fresh dialysis fluid, and a fluid drain. The APD machine pumps fresh dialysis fluid from the dialysis fluid source, through the catheter, and into the patient's peritoneal cavity. The APD machine also allows the dialysis fluid to remain in the cavity and allows the transfer of waste products, toxins, and excess water to occur. The source can include multiple liters of dialysis fluid, which includes several solution bags. The APD machine pumps the used or waste dialysis fluid from the peritoneal cavity, through the catheter, and pumps it to the drain. As with the manual process, several drain, fill, and dwell cycles occur in the dialysis device. A “last fill” can occur at the end of the APD treatment. The last fill fluid can remain in the patient's peritoneal cavity until the next treatment begins, or it can be manually emptied at some point during the day.

[0010] As described above, dialysis machines for hemodialysis or peritoneal dialysis typically require a large amount of fresh dialysis fluid to be used during the respective treatment. Handling relatively heavy bags of a large amount of stored standby dialysis fluid (e.g., 5 / 8 liter bags) can sometimes be problematic and requires effort and storage space. This is particularly (but not exclusively) relevant in the case of home dialysis, where the patient or his / her family member has to handle the fluid reservoir. Accordingly, there is a need to provide an improved system that is capable of producing and possibly temporarily storing a specific amount of medical fluid starting from fresh (pre-treated) water and appropriate concentrates.

[0011] Some prior art documents disclose the preparation of dialysis fluid from dry concentrates, mainly for HD. Also, the general concept of mixing PD fluid from concentrates is known.

[0012] Patent document EP1312386A2 discloses a bag with a dry concentrate (e.g., an acid concentrate); the system is for preparing dialysis fluid for hemodialysis. The bag contains a diluted concentrate solution and has two separate ports. Water is pumped into the bag via one port, whereby the dry concentrate is dissolved. After the bag is filled with a specific amount of water, the diluted solution is circulated to ensure its dissolution. Thereafter, the fluid can be pumped to a dialysis device for use.

[0013] It is also known from patent document US10195329B2 that a dry concentrate (bicarbonate) is mixed with water, and conductivity measurement is used to determine whether the concentrate is properly dissolved. The system prepares a dialysis solution online for dialysis.

[0014] It is known from patent document US2019 / 0060850A1 that there is a container filled with a concentrate, and it is mixed with water by recirculation. A medical system for producing a dialysis solution for hemodialysis directly produces a batch of solution.

[0015] It is known from patent document EP2305331A1 that powders are dissolved in two different containers and circulated in a circulation line. When the powders are dissolved, a flow chamber is used to meter and check the conductivity.

[0016] Patent document US2020 / 0390956A1 describes a PD machine for preparing a PD solution from RO water.

[0017] Patent document EP3222303B1 shows that powders are mixed with water, and the dialysis solutions from drug A and drug B are mixed into a first container, recirculated, and sent to a second container, from which it is sent to a dialysis device for use.

[0018] Patent Document US2019262522A1 discloses mixing a penetrant, an electrolyte, and water in a mixing container for mixing a liquid concentrate into a PD fluid. Summary of the Invention

[0019] The present disclosure describes systems and methods for producing medical fluids, in particular, the medical fluid is a dialysis fluid, which includes peritoneal dialysis ("PD") fluid and hemodialysis ("HD") fluid. Although the present disclosure focuses more on PD fluid, the teachings discussed herein are also applicable to other processed and injectable fluids, such as continuous renal replacement therapy ("CRRT") fluids including HD fluid, replacement or substitution fluids for hemofiltration ("HF") and hemodiafiltration ("HDF"), lactated Ringer's solution, etc. A medical fluid generating device receives water purified by a water purification device (e.g., a reverse osmosis device), or alternatively, receives water that is first purified inside the device and then used to prepare a suitable dialysis fluid. In the example of PD fluid, pure water is mixed with a PD concentrate and stored in a mixing container or bag when preparing PD fluid; generally, two PD concentrates are used, including an electrolyte, a penetrant (such as glucose), and a buffer concentrate. In the example of HD fluid, pure water is mixed with one or two concentrates, such as A concentrate and B concentrate, including a buffer concentrate (e.g., bicarbonate, acetate, or lactate) and an electrolyte concentrate including sodium, calcium, magnesium, and potassium ions, and stored in a mixing container or bag.

[0020] According to the disclosure set forth herein and without limiting the disclosure in any way, in a first independent aspect that can be combined with any other aspect or part thereof described herein, a medical fluid generating device (1) includes: - A fluid circuit (14) including a main fluid line (4), the main fluid line (4) having an inlet point (5) for receiving water; - A pump (8) configured to operate on the main fluid line (4) to circulate fluid at least in the main fluid line (4); - At least one of the following: · A main concentrate container (2) having at least one port (6, 7) in fluid communication with the main fluid line (4); · An auxiliary concentrate container (3) having at least one port (9, 10) in fluid communication with the main fluid line (4); - A mixing container (11) having an inlet (12) in fluid communication with the main fluid line (4) and an outlet (13) in fluid communication with the main fluid line (4); - A plurality of valves configured to operate on the fluid circuit (14), the plurality of valves being configurable to define different fluid paths for the fluid inside the fluid circuit (14), - A control unit (24), configured to operate the pump (8) and the plurality of valves.

[0021] In a second independent aspect, there is provided a medical fluid generating device (1), comprising: - A fluid circuit (14), including a main fluid line (4), the main fluid line (4) having an inlet point (5) for receiving water; - A pump (8), configured to operate on the main fluid line (4) to circulate fluid at least in the main fluid line (4); - A plurality of valves, configured to operate on the fluid circuit (14), the plurality of valves being configurable to define different fluid paths for the fluid inside the fluid circuit (14), - A support structure (42), accommodating the fluid circuit (14), the pump (8) and the plurality of valves, and including: · Optionally, an inlet (5a) for water, in particular, the inlet (5a) defining the inlet point (5) for receiving water; · A first main container inlet (43, 44), which is part of the fluid circuit (14) for fluid communication with the main concentrate container (2), the first main container inlet (43, 44) being in fluid communication with the main fluid line (4); and · A first auxiliary container inlet (45, 46), which is part of the fluid circuit (14) for fluid communication with the auxiliary concentrate container (3), the first auxiliary container inlet (45, 46) being in fluid communication with the main fluid line (4); - A control unit (24), configured to operate the pump (8) and the plurality of valves, wherein the medical fluid generating device further includes at least one of the following: - A mixing container inlet (47) and a mixing container outlet (48), the mixing container inlet (47) being part of the fluid circuit (14), the mixing container outlet (48) being part of the fluid circuit (14), the mixing container inlet (47) and the mixing container outlet (48) being for fluid communication with the inlet (12) of the mixing container (11) and the outlet (13) of the mixing container (11) respectively, the mixing container inlet (47) and the mixing container outlet (48) being in fluid communication with the main fluid line (4) respectively; - A mixing container (11), having an inlet (12) in fluid communication with the main fluid line (4) and an outlet (13) in fluid communication with the main fluid line (4), wherein the fluid circuit (14) includes: · A medical fluid outlet (27) for providing a medical fluid and a medical fluid outlet line (28) for carrying the medical fluid to the medical fluid outlet (27), the medical fluid outlet line (28) being configured to receive fluid from the main fluid line (4), and the medical fluid outlet line (28) being placed downstream of the pump (8); · A mixing container outlet line (16) connecting the outlet (13) of the mixing container (11) to a mixing container outlet junction or a first junction (j1) on the main fluid line (4), the first junction (j1) being placed upstream of the pump (8); · A mixing container inlet line (15) connecting a sixth junction (j6) on the main fluid line (4) to the inlet (12) of the mixing container (11), the sixth junction (j6) being placed downstream of the pump (8); · A main concentrate container outlet line (32, 36) connecting a first main container inlet (43, 44) to a main concentrate container junction (j4, j5) on the main fluid line (4), the main concentrate container junction (j4, j5) being placed upstream of the pump (8); · An auxiliary concentrate container outlet line (40, 41) connecting a first auxiliary container inlet (45, 46) to an auxiliary concentrate container junction (j2, j3) on the main fluid line (4), wherein the auxiliary concentrate container junction (j2, j3) is placed upstream of the pump (8).

[0022] A main fluid line (4) is provided, wherein the pump (8) is configured to operate, and the main fluid line (4) has junctions specially placed for the mixing container inlet and outlet lines across the pump and junctions for the main concentrate container outlet line and the main concentrate container outlet line upstream of the pump, allowing the creation of a fluid path that can use a single pump for all fluid generation steps. The various fluids always move along the main fluid line (4) controlled by the pump (8) that only operates in the forward direction (i.e., it is not necessary to make them move in the reverse direction of pumping along the main line). This fluid circuit profile also allows the creation of appropriate recirculation paths that can be used, for example, to dissolve dry concentrates, dilute liquid concentrates, and / or homogenize the prepared mixtures.

[0023] In a third aspect, depending on the foregoing aspects, the medical fluid generation device further includes a conductivity meter (25) associated with the control unit (24), the conductivity meter (25) being configured to determine the conductivity of the fluid circulating in the medical fluid generation device, wherein the conductivity meter (25) is connected to the main fluid line (4) downstream of the mixing container outlet junction (j1), the auxiliary concentrate container junctions (j2, j3), and the main concentrate container junctions (j4, j5) and upstream of the mixing container inlet junction (j6), and optionally, upstream of the pump (8) and connected to the main fluid line (4).

[0024] In a fourth independent aspect, there is provided a medical fluid generation device (1) comprising: - a fluid circuit (14) including a main fluid line (4) having an inlet point (5) for receiving water; - a pump (8) configured to operate on the main fluid line (4) to circulate the fluid at least in the main fluid line (4); - a plurality of valves configured to operate on the fluid circuit (14), the plurality of valves being configurable to define different fluid paths for the fluid inside the fluid circuit (14); - a support structure (42) housing the fluid circuit (14), the pump (8), and the plurality of valves, the support structure (42) including an inlet defining the inlet point (5) for receiving water and at least one of the following: · a first main container inlet (43) and a second main container inlet (44), which are part of the fluid circuit (14) for fluid communication with the main concentrate container (2), the first main container inlet (43) and the second main container inlet (44) being in fluid communication with the main fluid line (4); · a first auxiliary container inlet (45) and a second auxiliary container inlet (46), which are part of the fluid circuit (14) for fluid communication with the auxiliary concentrate container (3), the first auxiliary container inlet (45) and the second auxiliary container inlet (46) being in fluid communication with the main fluid line (4); - a control unit (24) configured to operate the pump (8) and the plurality of valves; wherein the medical fluid generation device further includes at least one of the following: - A mixing container inlet (47) and a mixing container outlet (48), the mixing container inlet (47) being part of the fluid circuit (14), the mixing container outlet (48) being part of the fluid circuit (14), the mixing container inlet (47) and the mixing container outlet (48) being adapted to be in fluid communication with the inlet (12) of the mixing container (11) and the outlet (13) of the mixing container (11) respectively, and the mixing container inlet (47) and the mixing container outlet (48) being in fluid communication with the main fluid line (4) respectively; - A mixing container (11), having an inlet (12) in fluid communication with the main fluid line (4) and an outlet (13) in fluid communication with the main fluid line (4), wherein the fluid path at least includes: · A mixing recirculation path (R1), wherein the plurality of valves are configured to allow the fluid contained in the mixing container (11) to recirculate through the outlet (13), at least a part of the main fluid line (4), and the inlet (12), and the pump (8) is configured to operate on at least a part of the main fluid line (4); · A concentrate recirculation path (Z6, X5), wherein the plurality of valves are configured to allow the fluid contained in one of the main concentrate container (2) and the auxiliary concentrate container (3) to recirculate through one of the first main container inlet (43) and the first auxiliary container inlet (45), at least a part of the main fluid line (4), and the corresponding one of the second main container inlet (44) and the second auxiliary container inlet (46), and the pump (8) is configured to operate on at least a part of the main fluid line (4).

[0025] In a fifth independent aspect, there is provided a medical fluid generating device (1), comprising: - A fluid circuit (14), including a main fluid line (4), the main fluid line (4) having an inlet (5) for receiving water; - A pump (8), configured to operate on the main fluid line (4) to circulate the fluid at least in the main fluid line (4); - A plurality of valves, configured to operate on the fluid circuit (14), the plurality of valves being configurable to define different fluid paths for the fluid inside the fluid circuit (14), - A support structure (42), accommodating the fluid circuit (14), the pump (8), and the plurality of valves, the support structure (42) including at least one of the following: · Main container inlets (43, 44), which are part of the fluid circuit (14) for fluid communication with the main concentrate container (2), and the main container inlets (43, 44) are in fluid communication with the main fluid line (4); · Auxiliary container inlets (45, 46), which are part of a fluid circuit (14) for fluid communication with an auxiliary concentrate container (3), and the auxiliary container inlets (45, 46) are in fluid communication with the main fluid line (4); wherein the medical fluid generating device further comprises at least one of the following: - A mixing container inlet (47) and a mixing container outlet (48), the mixing container inlet (47) being part of the fluid circuit (14), the mixing container outlet (48) being part of the fluid circuit (14), the mixing container inlet (47) and the mixing container outlet (48) being for fluid communication with the inlet (12) and the outlet (13) of the mixing container (11) respectively, and the mixing container inlet (47) and the mixing container outlet (48) being in fluid communication with the main fluid line (4) respectively; - A mixing container (11) having an inlet (12) in fluid communication with the main fluid line (4) and an outlet (13) in fluid communication with the main fluid line (4), - A sensor (52) connected to the main fluid line (4) to measure a property of the fluid flowing in the main fluid line (4); - A control unit (24) configured to operate the pump (8) and the plurality of valves, and configured to receive a signal related to a property of the fluid flowing in the main fluid line (4) from the sensor (52); wherein the fluid path includes a mixing recirculation path (R1) that includes the outlet (13), at least a portion of the main fluid line (4), and the inlet (12), the pump (8) being configured to operate on at least a portion of the main fluid line (4), and wherein the control unit (24) is configured to control the plurality of valves to set the mixing recirculation path (R1) and allow the fluid contained in the mixing container (11) to recirculate through the mixing recirculation path (R1); wherein the control unit (24) is further configured to: ○ Recirculate the fluid in the mixing recirculation path (R1); ○ Detect a time-resolved change in the property of the fluid recirculating in the mixing recirculation path (R1), the time-resolved change in the property of the fluid being related to the uniformity of the fluid recirculating in the mixing recirculation path (R1) and the fluid recirculating in the mixing recirculation path (R1); ○ Interrupt the recirculation step when the time-resolved change meets a change criterion.

[0026] In a sixth independent aspect, there is provided a medical fluid generating device (1) comprising: - A fluid circuit (14), including a main fluid pipeline (4), the main fluid pipeline (4) having an inlet point (5) for receiving water; - A pump (8), configured to operate on the main fluid pipeline (4) to circulate the fluid at least in the main fluid pipeline (4); - A plurality of valves, configured to operate on the fluid circuit (14), the plurality of valves being configurable to define different fluid paths for the fluid inside the fluid circuit (14), - A support structure (42), accommodating the fluid circuit (14), the pump (8) and the plurality of valves, the support structure (42) including an inlet defining the inlet point (5) for receiving water and at least one of the following: · A first main container inlet (43, 44), which is part of the fluid circuit (14) for fluid communication with the main concentrate container (2), the first main container inlet (43, 44) being in fluid communication with the main fluid pipeline (4); · A first auxiliary container inlet (45, 46), which is part of the fluid circuit (14) for fluid communication with the auxiliary concentrate container (3), the first auxiliary container inlet (45, 46) being in fluid communication with the main fluid pipeline (4); - A control unit (24), configured to operate the pump (8) and the plurality of valves, wherein the medical fluid generating device (1) further includes at least one of the following: - A mixing container inlet (47) and a mixing container outlet (48), the mixing container inlet (47) being part of the fluid circuit (14), the mixing container outlet (48) being part of the fluid circuit (14), the mixing container inlet (47) and the mixing container outlet (48) being for fluid communication with the inlet (12) of the mixing container (11) and the outlet (13) of the mixing container (11) respectively, the mixing container inlet (47) and the mixing container outlet (48) being in fluid communication with the main fluid pipeline (4) respectively; - A mixing container (11), having an inlet (12) in fluid communication with the main fluid pipeline (4) and an outlet (13) in fluid communication with the main fluid pipeline (4).

[0027] In a seventh aspect according to aspect 6, the medical fluid generating device further includes at least one (and preferably includes two) of the following: · A main concentrate container (2), having at least one port (6, 7) in fluid communication with the main fluid pipeline (4), the port (6, 7) being in fluid communication with the first main container inlet (43, 44); · An auxiliary concentrate container (3) having at least one port (9, 10) in fluid communication with the main fluid line (4), the ports (9, 10) being in fluid communication with a first auxiliary container inlet (45, 46).

[0028] In an eighth aspect, according to any one of aspects 6 and 7, wherein an inlet (12) of the mixing container (11) is in fluid communication with a mixing container inlet (47), and an outlet (13) of the mixing container (11) is in fluid communication with a mixing container outlet (48).

[0029] In a ninth independent aspect, there is provided a medical fluid generating device (1) comprising: A fluid circuit (14) including a main fluid line (4), the main fluid line (4) having an inlet point (5) for receiving water; A pump (8) configured to operate on the main fluid line (4) to circulate fluid at least in the main fluid line (4); A main concentrate container (2) having at least one of: a first port (6) in fluid communication with the main fluid line (4) and a second port (7) in fluid communication with the main fluid line (4); an auxiliary concentrate container (3) having a first port (9) in fluid communication with the main fluid line (4) and a second port (10) in fluid communication with the main fluid line (4); A mixing container (11) having an inlet (12) in fluid communication with the main fluid line (4) and an outlet (13) in fluid communication with the main fluid line (4); A plurality of valves configured to operate on the fluid circuit (14), the plurality of valves being configurable to define different fluid paths for the fluid inside the fluid circuit (14), a control unit (24) configured to operate the pump (8) and the plurality of valves, wherein the fluid paths at least include: · A mixing recirculation path (R1), wherein the plurality of valves are configured to allow the fluid contained in the mixing container (11) to recirculate through the outlet (13), at least a portion of the main fluid line (4), and the inlet (12), and the pump (8) is configured to operate on at least a portion of the main fluid line (4); · A concentrate recirculation path (Z6, X5), wherein the plurality of valves are configured to allow the fluid contained in one of the main concentrate container (2) and the auxiliary concentrate container (3) to recirculate through the first port (6, 9), at least a portion of the main fluid line (4), and the second port (7, 10), and the pump (8) is configured to operate on at least a portion of the main fluid line (4).

[0030] In a tenth independent aspect, there is provided a method of generating a medical fluid using a medical fluid generation device (1), the device comprising: - a fluid circuit (14) including a main fluid line (4) having an inlet (5) for receiving water; - a pump (8) configured to operate on the main fluid line (4) to circulate fluid at least in the main fluid line (4); - a plurality of valves configured to operate on the fluid circuit (14), the plurality of valves being configurable to define different fluid paths for the fluid inside the fluid circuit (14); - a support structure (42) accommodating the fluid circuit (14), the pump (8) and the plurality of valves, the support structure (42) including at least one of the following: · a first main container inlet (43) and a second main container inlet (44), which are part of the fluid circuit (14) for fluid communication with a main concentrate container (2), the first main container inlet (43) and the second main container inlet (44) being in fluid communication with the main fluid line (4); · a first auxiliary container inlet (45) and a second auxiliary container inlet (46), which are part of the fluid circuit (14) for fluid communication with an auxiliary concentrate container (3), the first auxiliary container inlet (45) and the second auxiliary container inlet (46) being in fluid communication with the main fluid line (4); - a control unit (24) configured to operate the pump (8) and the plurality of valves, wherein the medical fluid generation device (1) further includes at least one of the following: - a mixing container inlet (47) and a mixing container outlet (48), the mixing container inlet (47) being part of the fluid circuit (14) and the mixing container outlet (48) being part of the fluid circuit (14), the mixing container inlet (47) and the mixing container outlet (48) being for fluid communication with an inlet (12) of a mixing container (11) and an outlet (13) of the mixing container (11) respectively, the mixing container inlet (47) and the mixing container outlet (48) being in fluid communication with the main fluid line (4) respectively; - a mixing container (11) having an inlet (12) in fluid communication with the main fluid line (4) and an outlet (13) in fluid communication with the main fluid line (4), The method includes: · controlling the plurality of valves to set a mixing recirculation path (R1) in the fluid circuit, the mixing recirculation path (R1) including an outlet (13), at least a part of the main fluid line (4) and an inlet (12), the pump (8) being configured to operate on at least a part of the main fluid line (4), · Recirculate the fluid contained in the mixing container (11) through the mixing recirculation path (R1); Recirculate; · Control the plurality of valves to set a concentrate recirculation path (Z6, X5) in the fluid circuit, the concentrate recirculation path (Z6, X5) including one of a first main container inlet (43) and a first auxiliary container inlet (45), at least a portion of the main fluid line (4), and a corresponding one of a second main container inlet (44) and a second auxiliary container inlet (46), and a pump (8) configured to operate on at least a portion of the main fluid line (4), · Recirculate the fluid contained in one of the main concentrate container (2) and the auxiliary concentrate container (3) through the concentrate recirculation path (Z6, X5).

[0031] In an eleventh independent aspect, a method of generating a medical fluid using a medical fluid generation device (1) is provided, the device including: - A fluid circuit (14) including a main fluid line (4) having an inlet (5) for receiving water; - A pump (8) configured to operate on the main fluid line (4) to circulate fluid at least in the main fluid line (4); - A plurality of valves configured to operate on the fluid circuit (14), the plurality of valves configurable to define different fluid paths for the fluid inside the fluid circuit (14), - A support structure (42) accommodating the fluid circuit (14), the pump (8), and the plurality of valves, the support structure (42) including at least one of the following: - Main container inlets (43, 44) that are part of the fluid circuit (14) for fluid communication with the main concentrate container (2), the main container inlets (43, 44) being in fluid communication with the main fluid line (4); - Auxiliary container inlets (45, 46) that are part of the fluid circuit (14) for fluid communication with the auxiliary concentrate container (3), the auxiliary container inlets (45, 46) being in fluid communication with the main fluid line (4); wherein the medical fluid generation device (1) further includes at least one of the following: - A mixing vessel inlet (47) and a mixing vessel outlet (48), the mixing vessel inlet (47) being part of the fluid circuit (14), the mixing vessel outlet (48) being part of the fluid circuit (14), the mixing vessel inlet (47) and the mixing vessel outlet (48) being adapted to be in fluid communication with the inlet (12) and the outlet (13) of the mixing vessel (11) respectively, and the mixing vessel inlet (47) and the mixing vessel outlet (48) being in fluid communication with the main fluid line (4) respectively; - A mixing vessel (11) having an inlet (12) in fluid communication with the main fluid line (4) and an outlet (13) in fluid communication with the main fluid line (4), - A sensor (52) connected to the main fluid line (4) to measure a property of the fluid flowing in the main fluid line (4); - A control unit (24) configured to operate the pump (8) and the plurality of valves and configured to receive a signal related to the property of the fluid flowing in the main fluid line (4) from the sensor (52); The method comprises: ○ Configuring a mixing recirculation path (R1) in the fluid circuit, the mixing recirculation path (R1) including the outlet (13), at least a portion of the main fluid line (4), and the inlet (12), the pump (8) being configured to operate on at least a portion of the main fluid line (4); ○ Recirculating the fluid in the mixing recirculation path (R1); ○ Detecting a time-resolved change in the property of the fluid recirculating in the mixing recirculation path (R1), the time-resolved change in the property of the fluid being related to the uniformity of the fluid recirculating in the mixing recirculation path (R1); ○ Interrupting the recirculation step when the time-resolved change meets a change criterion.

[0032] In the following aspects, the method steps for the independent method aspects 10 and 11 are performed by the control unit of the device.

[0033] In aspect 12 according to any one of the foregoing aspects, the fluid circuit (14) includes a mixing vessel inlet line (15) that connects a sixth junction point (j6) on the main fluid line (4) to the inlet (12) of the mixing vessel (11), and the plurality of valves includes a mixing vessel inlet valve (VMI) configured to operate on the mixing vessel inlet line (15).

[0034] In aspect 13 according to the foregoing aspects, the sixth junction point (j6) is placed downstream of the pump (8).

[0035] In aspect 14 according to any of the foregoing aspects, the device further comprises a pressure sensor (P2) configured to sense the pressure of the fluid in the main fluid line (4) downstream of the pump (8).

[0036] In aspect 15 according to aspect 13, the pressure sensor (P2) is placed on the mixing vessel inlet line (15), optionally between the sixth junction point (j6) and the mixing vessel inlet valve (VMI).

[0037] In aspect 16 according to any of the foregoing aspects, the fluid circuit (14) comprises a mixing vessel outlet line (16) that connects the outlet (13) of the mixing vessel (11) to a first junction point (j1) on the main fluid line (4), and the plurality of valves comprises a mixing vessel outlet valve (VMO) configured to operate on the mixing vessel outlet line (16).

[0038] In aspect 17 according to the foregoing aspect, the first junction point (j1) is placed upstream of the pump (8).

[0039] In aspect 18 according to any of the foregoing aspects, the device further comprises an auxiliary pressure sensor (P1) configured to sense the pressure occurring on the main fluid line (4) upstream of the pump (8).

[0040] In aspect 19 according to aspect 16, the auxiliary pressure sensor (P1) is placed on the mixing vessel outlet line (16), optionally between the first junction point (j1) and the mixing vessel outlet valve (VMO).

[0041] In aspect 20 according to any of the foregoing aspects, the device further comprises a sensor (17) for providing information related to the volume of fluid contained in the mixing vessel (11), in particular, wherein the sensor (17) is selected from the group consisting of a weighing scale and a level sensor.

[0042] In aspect 21 according to any of the foregoing aspects, the device further comprises at least one sterilization device (18) configured to operate on the volume of fluid contained in the mixing vessel (11), for example, the sterilization device (18) is a UV sterilization device, wherein, in particular, the sterilization device (18) is placed inside the mixing vessel (11), for example, on the bottom wall (11a) of the mixing vessel (11).

[0043] In a 22nd aspect according to any of the foregoing aspects, the device further comprises one or more sterilization means configured to operate on the fluid contained in the fluid circuit (14), for example the one or more sterilization means are UV sterilization means, wherein in particular the one or more sterilization means are configured to operate on the main pipeline (4) and / or the mixing vessel inlet pipeline (15) and / or the mixing vessel outlet pipeline (16).

[0044] In a 23rd aspect according to any of the foregoing aspects, the mixing vessel (11) further comprises a vent (19), the vent (19) comprising a vent pipeline (20) for selectively discharging excess air, optionally comprising a filter (21) for filtering any air passing through the vent pipeline (20) and / or an air valve (22) for selectively blocking the air passage of the air passing through the vent pipeline (20), the air valve being placed along the vent pipeline (20), in particular the air valve (22) being inserted on the vent pipeline (20) between the mixing chamber (11) and the filter (21).

[0045] In a 24th aspect according to the foregoing aspect, the vent pipeline (20) is connected to an air discharge portion.

[0046] In a 25th aspect according to any of the foregoing aspects, the mixing vessel (11) is a closed vessel having: · only an inlet (12) and an outlet (13) for communicating the internal volume with the external fluid; or, · only an inlet (12), an outlet (13) and a vent (19) for communicating the internal volume with the external fluid, wherein the vent (19) is placed on the top (11b) of the mixing vessel (11).

[0047] In a 26th aspect according to any of the foregoing aspects, the mixing vessel (11) is a non-removable and / or durable (non-disposable) vessel.

[0048] In a 26 bis aspect according to any of the foregoing aspects, the fluid circuit (14) is durable. The durable fluid circuit (14) can be disinfected or sterilized when appropriate and then reused for subsequent medical fluid preparation. This simplifies the operation of the user in preparing the device and reduces waste as there is no disposable circuit to be arranged on the device and then discarded.

[0049] In aspect 27 according to any of the foregoing aspects, the mixing container (11) is a removable and / or disposable container. In particular, both the inlet (12) and the outlet (13) of the mixing container (11) are removably connected to the main fluid line (4). Optionally, both the inlet (12) and the outlet (13) of the mixing container (11) include self-sealing valves to prevent fluid from leaving the mixing container once it is separated from the medical fluid generating device.

[0050] In aspect 28 according to the foregoing aspect, the mixing container (11) is a flexible bag.

[0051] In aspect 29 according to any of the foregoing aspects, the device further includes a heater (23). The heater (23) is controlled by a control unit (24) and is configured to heat the fluid circulating in the medical fluid generating device. The heater is placed on the main fluid line (4).

[0052] In aspect 30 according to any of the foregoing aspects, the device further includes at least one sensor (52). The at least one sensor (52) is placed on the main fluid line (4) and is configured to measure the properties of the fluid flowing in the main fluid line (4). The control unit (24) is configured to receive signals related to the properties of the fluid flowing in the main fluid line (4) from the sensor (52). In particular, the properties of the fluid flowing in the main fluid line (4) are selected from the group consisting of the conductivity of the fluid flowing in the main fluid line (4), the concentration of substances in the fluid flowing in the main fluid line (4), concentration-related physical properties (such as the speed of sound, viscosity, density, the temperature of the fluid flowing in the main fluid line (4)), and the optical properties of the fluid flowing in the main fluid line (4) and combinations thereof.

[0053] In aspect 31 according to the foregoing aspect, the device includes two sensors (52, 53) placed in series with each other on the main fluid line (4), and both are configured to measure the properties of the fluid flowing in the main fluid line (4). The control unit (24) is configured to receive signals from the sensors (52, 53).

[0054] In aspect 32 according to any of the foregoing aspects, the device further includes a conductivity meter (25) associated with the control unit (24). The control unit (24) is configured to determine the conductivity of the fluid circulating in the medical fluid generating device. In particular, the conductivity meter (25) is placed on the main fluid line (4), downstream of the first junction (j1), the third junction (j3), and the fifth junction (j5) and upstream of the sixth junction (j6), and optionally, upstream of the pump (8).

[0055] In a 33rd aspect according to the foregoing aspects, the device further includes a second conductivity meter (26) associated with the control unit (24), the second conductivity meter (26) being configured to independently determine the conductivity of the fluid circulating in the medical fluid generation device, both the conductivity meter (25) and the second conductivity meter (26) being configured to send independent signals to the control unit (24), the control unit (24) being configured to use the conductivity measurement results from the second conductivity meter (26) to determine the conductivity of the same fluid, the second conductivity meter (26) being placed on the main fluid line (4), downstream of the first junction point (j1), the third junction point (j3) and the fifth junction point (j5) and upstream of the sixth junction point (j6), and optionally, upstream of the pump (8).

[0056] In a 34th aspect depending on the foregoing aspects 29 and 32, the heater (23) is placed upstream of the pump (8) and / or the conductivity meter (25). For example, the conductivity meter (25) is inserted between the heater (23) and the pump (8).

[0057] In a 34 bis aspect according to aspects 30 and 32, the at least one sensor (52) is the conductivity meter (25). In particular, according to aspects 31 and 32, the second sensor (53) is the second conductivity meter (26).

[0059] In a 35th aspect according to any of the foregoing aspects, the device further includes a temperature sensor (T1) for sensing the temperature of the fluid in the main fluid line (4), in particular, the temperature sensor (T1) is placed downstream of the first junction point (j1), the third junction point (j3) and the fifth junction point (j5) and upstream of the sixth junction point (j6), and optionally, upstream of the pump (8).

[0060] In a 36th aspect according to the foregoing aspects, the temperature sensor (T1) is an external sensor or a sensor integrated in the conductivity meters (25, 26).

[0061] In a 37th aspect according to the foregoing aspects and aspect 22, the control unit (24) is configured to receive a temperature signal from the temperature sensor (T1) and is configured to control the heater (23) at least based on the received temperature sensor (T1).

[0062] It is desired to heat the fluid to obtain a stable conductivity reading from the conductivity meter (25). The conductivity meter (25) is typically configured for a certain temperature or a small temperature interval, at which time the conductivity meter (25) accurately measures the conductivity. This temperature can be 37 degrees Celsius so as to always avoid the need to cool the fluid (for example, if the room temperature is 30 °C and the set temperature for measuring conductivity is 21 °C, then the fluid temperature will need to be cooled). Additionally, the fluid should be heated to 37 degrees anyway before the patient enters (however, in some embodiments, this heating can be performed by a heater (not shown) located downstream).

[0063] In aspect 38 according to any of the foregoing aspects, the device further includes an auxiliary temperature sensor (T2) for sensing the temperature of the fluid in the main fluid line (4). In particular, the temperature sensor (T2) is placed downstream of the first junction point (j1), the third junction point (j3), and the fifth junction point (j5) and upstream of the sixth junction point (j6), and optionally, upstream of the pump (8). The auxiliary temperature sensor (T2) is an external sensor or a sensor integrated in the conductivity meters (25, 26).

[0064] In aspect 39 according to any of the foregoing aspects, the pump (8) is a positive displacement pump.

[0065] In aspect 40 according to any of the foregoing aspects, the support structure (42) further includes a medical fluid outlet (27) for supplying medical fluid to the connected medical device, and the fluid circuit (14) includes a medical fluid outlet line (28) for carrying the medical fluid to the medical fluid outlet (27). The plurality of valves includes a medical fluid outlet valve (VFO) configured to operate on the medical fluid outlet line (28).

[0066] In aspect 41 according to the foregoing aspect, when depending on aspect 6, wherein the first end of the medical fluid outlet line (28) is connected to the mixing container inlet line (15) and the second end of the medical fluid outlet line (28) is connected to the medical fluid outlet (27). Optionally, the first end is connected upstream of the mixing container inlet valve (VMI) to receive the medical fluid flowing in a part of the mixing container inlet line (15) upstream of the mixing container inlet valve (VMI).

[0067] In aspect 42 according to any of the foregoing two aspects, the medical fluid outlet line (28) is configured to receive fluid from or for the main fluid line (4) and is placed downstream of the pump (8).

[0068] In a 43rd aspect according to any of the foregoing aspects, the fluid circuit (14) further comprises a discharge port (29) for discharging fluid to a discharge section and a discharge outlet line (30) for carrying fluid from the main line (4) to the discharge port (29), and the plurality of valves further comprises a discharge valve (VDR) configured to operate on the discharge outlet line (30).

[0069] In a 44th aspect according to any of the foregoing aspects, the fluid circuit (14) comprises a main concentrate container inlet line (31) connecting a junction point, in particular a sixth junction point (j6), on the main fluid line (4) to a first main container inlet (43, 44), and the plurality of valves comprises a main concentrate container inlet valve (VGI) configured to operate on the main concentrate container inlet line (31).

[0070] In a 45th aspect according to the foregoing aspect, the sixth junction point (j6) is placed downstream of the pump (8).

[0071] In a 46th aspect according to any of the foregoing aspects, when depending on the 4th, 9th or 10th aspect, the medical device further comprises a concentration sensor (SG) configured to sense the concentration of at least one substance in the fluid flowing in the concentrate recirculation path.

[0072] In a 47th aspect according to the foregoing aspect, when depending on the 31st aspect, the concentration sensor (SG) is placed on the main concentrate container inlet line (31), optionally between the main concentrate container inlet valve (VGI) and the first main container inlet (43).

[0073] In a 48th aspect according to any of the foregoing aspects, the fluid circuit (14) comprises a main concentrate container outlet line (32) connecting a second main container inlet (44) to a fifth junction point (j5) on the main fluid line (4), and the plurality of valves comprises a main concentrate container outlet valve (VGO) configured to operate on the main concentrate container outlet line (32).

[0074] In a 49th aspect according to the foregoing aspect, the fifth junction point (j5) is placed upstream of the pump (8).

[0075] In a 50th aspect according to any of the foregoing aspects, the medical device further comprises a degassing chamber (33) configured to allow air removal and placed on a main concentrate container outlet line (32) between a first main container inlet (43, 44) and a main concentrate container outlet valve (VGO). The degassing chamber (33) includes a vent (34) which includes a vent line (35) for selectively discharging excess air and optionally includes a gas valve (VGA) configured to operate on the vent line (35) to selectively block the air passage through said vent line (35). In particular, the gas valve (VGA) is inserted in the vent line (35) between the main concentrate container (2) and the discharge section.

[0076] In a 51st aspect according to the foregoing aspect, the medical device further comprises a level sensor associated with the degassing chamber (33) to check the level in the degassing chamber (33).

[0077] In a 52nd aspect according to any of the foregoing two aspects, when depending on aspect 48, the degassing chamber (33) is placed on the main concentrate container outlet line (32), optionally between a second port (7) and the main concentrate container outlet valve (VGO).

[0078] In a 53rd aspect according to any of the foregoing aspects, the medical device further comprises an auxiliary degassing chamber (51) configured to allow air removal and placed on an auxiliary concentrate container outlet line (40) between a first auxiliary container inlet (45, 46) and an auxiliary concentrate container outlet valve (VAO). The auxiliary degassing chamber (51) includes a vent (34) which includes a vent line (35a) for selectively discharging excess air and optionally includes an auxiliary gas valve (VGA2) configured to operate on the vent line (35a) to selectively block the air passage through said vent line (35a). In particular, the auxiliary gas valve (VGA2) is inserted in the vent line (35a) between the auxiliary concentrate container (3) and the discharge section.

[0079] In a 54th aspect according to the foregoing aspect, the medical device further comprises a level sensor associated with the auxiliary degassing chamber (51) to check the level in the auxiliary degassing chamber (51).

[0080] In aspect 55 according to any of the foregoing aspects, the fluid circuit (14) includes a first concentrate mixing line (36) that connects a fourth junction point (j4) on the main fluid line (4) to a first main container inlet (43, 44), particularly to an intermediate point (31a) of the main concentrate container inlet line (31), and the plurality of valves includes a first concentrate mixing valve (VGM) configured to operate on the first concentrate mixing line (36). Wherein, the fourth junction point (j4) is placed upstream of the pump (8).

[0081] In aspect 56 according to the foregoing aspect, the connection to the intermediate point (31a) of the main concentrate container inlet line (31) is close to the first main container inlet (43).

[0082] In aspect 57 according to any of the foregoing aspects, the medical device further includes a dry concentrate accommodated in the main concentrate container (2) in the form of powder or granules.

[0083] In aspect 58 according to the foregoing aspect, the dry concentrate includes an osmotic agent, particularly hydrated glucose.

[0084] In aspect 59 according to any of the foregoing two aspects, the dry concentrate contains at least 80% of hydrated glucose, and particularly 100% of hydrated glucose.

[0085] In aspect 60 according to any of the foregoing aspects, the main concentrate container (2) is a flexible bag that includes two plastic films welded together to define an accommodation space for the concentrate.

[0086] In aspect 61 according to any of the foregoing aspects, the main concentrate container (2) is a dry concentrate bag for preparing dialysis fluid, and the dry concentrate bag includes: · Two plastic films welded together along a welding line to define an accommodation space for the dry concentrate; · The dry concentrate accommodated in the accommodation space; · An inlet portion including an inlet port for receiving fluid, and the inlet port is placed corresponding to the bottom region under the use conditions of the dry concentrate bag. · An outlet portion including an outlet port for allowing the fluid mixed with the dry concentrate to leave the accommodation space, and the outlet port is placed corresponding to the top region under the use conditions of the dry concentrate bag. · An outlet portion including an outlet port for allowing the fluid mixed with the dry concentrate to leave the accommodation space, and the outlet port is placed corresponding to the top region under the use conditions of the dry concentrate bag.

[0087] In aspect 62 according to the foregoing aspects, the inlet portion includes a first inclined weld line and a second inclined weld line, both the first inclined weld line and the second inclined weld line being exposed from the inlet port and defining a lower conical portion of the accommodation space, and the inlet port being placed at the lowest point of the lower conical portion.

[0088] In aspect 63 according to any one of the foregoing two aspects, the outlet portion includes a third inclined weld line and a fourth inclined weld line, both the third inclined weld line and the fourth inclined weld line converging to the outlet port and defining an upper conical portion of the accommodation space, and the outlet port being placed at the highest point of the upper conical portion.

[0089] In aspect 64 according to any one of the foregoing aspects, the fluid circuit (14) includes an auxiliary concentrate container inlet line (37) that connects a junction point, in particular the sixth junction point (j6), on the main fluid line (4) to a first auxiliary container inlet (45, 46), and the plurality of valves includes an auxiliary concentrate container inlet valve (VAI) that is configured to operate on the auxiliary concentrate container inlet line (37).

[0090] In aspect 65 according to the foregoing aspect, the sixth junction point (j6) is placed downstream of the pump (8).

[0091] In aspect 66 according to any one of the foregoing two aspects, the auxiliary concentrate container inlet line (37) includes a common pipe (38) having a main concentrate container inlet line (31), the common pipe (38) starting at a junction point, in particular the sixth junction point (j6), and reaching a branch (39) where the main concentrate container inlet line (31) and the auxiliary concentrate container inlet line (37) separate.

[0092] In aspect 67 according to the foregoing aspect, the common pipe (38) does not include any valves.

[0093] In aspect 68 according to any one of the foregoing two aspects, the auxiliary concentrate container inlet valve (VAI) is configured to operate downstream of the branch (39).

[0094] In aspect 69 according to any one of the foregoing two aspects, the concentrate container inlet valve (VGI) is configured to operate on the main concentrate container inlet line (31) downstream of the branch (39).

[0095] In aspect 70 according to any of the foregoing aspects, the fluid circuit (14) includes an auxiliary concentrate container outlet line (40) that connects a second port (10) of the auxiliary concentrate container (3) to a third junction point (j3) on the main fluid line (4), and the plurality of valves includes an auxiliary concentrate container outlet valve (VAO) that is configured to operate on the auxiliary concentrate container outlet line (40).

[0096] In aspect 71 according to the foregoing aspect, the third junction point (j3) is placed upstream of the pump (8).

[0097] In aspect 72 according to any of the foregoing aspects, the fluid circuit (14) includes a second concentrate mixing line (41) that connects a second junction point (j2) on the main fluid line (4) to a first auxiliary container inlet (45, 46), in particular to an intermediate point (37a) of the auxiliary concentrate container inlet line (37), and the plurality of valves includes a second concentrate mixing valve (VAM) that is configured to operate on the second concentrate mixing line (41). wherein the second junction point (j2) is placed upstream of the pump (8).

[0098] In aspect 73 according to the foregoing aspect, the connection to the intermediate point (37a) at the auxiliary concentrate container inlet line (37) is close to the first auxiliary container inlet (45).

[0099] In aspect 74 according to any of the foregoing aspects, the auxiliary concentrate container (3) includes a liquid concentrate (LC’), in particular an electrolyte and / or a buffer.

[0100] In aspect 75 according to any of the foregoing aspects, the main fluid line (4) includes a plurality of first junction points (j1), second junction points (j2), third junction points (j3), fourth junction points (j4), and fifth junction points (j5), and each fluid line of the fluid circuit (14) departs from each junction point (j1, j2, j3, j4, j5), and the pump (8) is downstream of the plurality of junction points, wherein the second junction point (j2) is placed upstream of the third junction point (j3) on the main fluid line (4); and / or the fourth junction point (j4) is placed upstream of the fifth junction point (j5) on the main fluid line (4); and / or the first junction point (j1) is placed upstream of each of the other junction points (j2, j3, j4, j5).

[0101] In aspect 76 according to the foregoing aspects, the plurality of valves includes a water inlet valve (VWI) placed on the main fluid line (4) upstream of the plurality of junctions (j1, j2, j3, j5).

[0102] In aspect 77 according to any of the foregoing aspects, the control unit (24) is configured to control the pump (8) to pump the fluid inside the main line (4) in the forward direction from upstream of the pump, at the upstream of the pump there are an inlet point (5) for receiving water, a first junction (j1), a third junction (j3) and a fifth junction (j5), and the control unit (24) is configured to control the pump (8) to pump the fluid in the main line (4) in the forward direction towards the downstream of the pump where the sixth junction (j6) is placed. The control unit (24) is not configured to control the pump (8) to pump the fluid in the main line (4) in the reverse direction from the sixth junction (j6) towards any one of the inlet point (5) for receiving water, the first junction (j1), the third junction (j3) and the fifth junction (j5) during the step for generating the medical fluid.

[0103] In aspect 78 according to any of the foregoing aspects, the device is configured for preparing dialysis fluid, in particular PD fluid or HD fluid.

[0104] In aspect 79 according to any of the foregoing aspects, the medical device further includes a water purification device configured to supply pure water to the inlet point (5).

[0105] The water purification device can be an external device that supplies pure water to the water inlet 5a, or alternatively, an internal device that receives the water to be purified from the inlet 5a and supplies pure water to the inlet point 5a. In the latter configuration, the water purification device is built inside the support structure (42).

[0106] In aspect 80 according to the foregoing aspects, the water purification device includes a central water purification station configured to supply the inlet point (5) or an independent water purifier configured to supply the inlet point (5).

[0107] In aspect 81 according to any of the foregoing aspects, the fluid path includes a mixing recirculation path (R1), and the mixing recirculation path (R1) includes a mixing container (11), an outlet (13), a mixing container outlet line (16) connecting the outlet (13) of the mixing container (11) to the first junction (j1) on the main fluid line (4), at least a part of the main fluid line (4) on which the pump (8) is configured to operate from the first junction (j1) to the sixth junction (j6), a mixing container inlet line (15) connecting the main fluid line (4) to the inlet (12) of the mixing container (11), and the inlet (12).

[0108] In an 82nd aspect according to the foregoing aspects, the mixing recirculation path (R1) includes a mixing vessel outlet valve (VMO) configured to operate on the mixing vessel outlet line (16) and a mixing vessel inlet valve (VMI) configured to operate on the mixing vessel inlet line (15). When the control unit (24) controls the plurality of valves to set the mixing recirculation path, the mixing vessel outlet valve (VMO) and the mixing vessel inlet valve (VMI) are configured to allow fluid to recirculate in the mixing recirculation path. In particular, other valves among the plurality of valves configured to operate on the fluid circuit (14) and configurable to allow fluid to enter or leave the mixing recirculation path are closed. Optionally, all other valves different from the mixing vessel outlet valve (VMO) and the mixing vessel inlet valve (VMI) among the plurality of valves configured to operate on the fluid circuit (14) are closed.

[0109] In an 83rd aspect according to any of the foregoing aspects, the fluid path includes a first concentrate recirculation path (Z6), which includes a main concentrate container (2), a second port (7), a main concentrate container outlet line (32) connecting the second port (7) of the main concentrate container (2) to a fifth junction point (j5) on the main fluid line (4), at least a part of the main fluid line (4) extending from the fifth junction point (j5) to a sixth junction point (j6) on which a pump (8) is configured to operate, a main concentrate container inlet line (31) connecting the sixth junction point (j6) on the main fluid line (4) to the first port (6) of the main concentrate container (2), and the first port (6).

[0110] In an 84th aspect according to any of the foregoing aspects, the concentrate recirculation path (Z6, X5) includes a first concentrate recirculation path (Z6), and the main concentrate container (2) has a first port (6) and a second port (7), the first port (6) and the second port (7) are each in fluid communication with the main fluid line (4), the first port (6) is in fluid communication with a first main container inlet (43), the second port (7) is in fluid communication with a second main container inlet (44), wherein the first concentrate recirculation path (Z6) includes the main concentrate container (2), the second port (7), the second main container inlet (44), a main concentrate container outlet line (32) connecting the second main container inlet (44) to a fifth junction point (j5) on the main fluid line (4), at least a part of the main fluid line (4) on which a pump (8) extending from the fifth junction point (j5) to a sixth junction point (j6) is configured to operate, a main concentrate container inlet line (31) connecting the sixth junction point (j6) on the main fluid line (4) to the first main container inlet (43), and the first port (6) of the main concentrate container (2).

[0111] In an 85th aspect according to any of the foregoing aspects, the first concentrate recirculation path (Z6) includes a main concentrate container outlet valve (VGO) configured to operate on the main concentrate container outlet line (32) and a main concentrate container inlet valve (VGI) configured to operate on the main concentrate container inlet line (31), when the control unit (24) controls the plurality of valves to set the first concentrate recirculation path, the main concentrate container outlet valve (VGO) and the main concentrate container inlet valve (VGI) are configured to allow fluid to recirculate in the first concentrate recirculation path, in particular, other valves among the plurality of valves configured to operate on the fluid circuit (14) and configurable to allow fluid to enter or leave the first concentrate recirculation path are closed, optionally, all other valves different from the main concentrate container outlet valve (VGO) and the main concentrate container inlet valve (VGI) among the plurality of valves configured to operate on the fluid circuit (14) are closed.

[0112] In an 86th aspect according to any of the foregoing aspects, the fluid path includes an auxiliary concentrate recirculation path (X5), wherein the plurality of valves are configured to allow fluid contained in the other of the main concentrate container (2) and the auxiliary concentrate container (3) to recirculate through the first ports (6, 9), at least a part of the main fluid line (4) on which the pump (8) is configured to operate, and the second ports (7, 10).

[0113] In an 87th aspect according to the foregoing aspects, the auxiliary concentrate recirculation path (X5) includes an auxiliary concentrate container (3), a second port (10), an auxiliary concentrate container outlet line (40) connecting the second port (10) of the auxiliary concentrate container (3) to a third junction point (j3) on the main fluid line (4), at least a portion of the main fluid line (4) extending from the third junction point (j3) to a sixth junction point (j6) where a pump (8) is configured to operate thereon, an auxiliary concentrate container inlet line (37) connecting the sixth junction point (j6) on the main fluid line (4) to a first port (9) of the auxiliary concentrate container (3), and the first port (9).

[0114] In an 88th aspect according to any of the foregoing aspects, the fluid path includes an auxiliary concentrate recirculation path (X5), wherein the plurality of valves are configured to allow fluid in the other of the main concentrate container (2) and the auxiliary concentrate container (3) to recirculate through the other of the first main container inlet (43) and the first auxiliary container inlet (45), at least a portion of the main fluid line (4) where the pump (8) is configured to operate thereon, and the corresponding other of the second main container inlet (44) and the second auxiliary container inlet (46).

[0115] In an 89th aspect according to the foregoing aspects, the auxiliary concentrate container (3) has a first port (9) and a second port (10), the first port (9) and the second port (10) are each in fluid communication with the main fluid line (4), the first port (9) is in fluid communication with the first auxiliary container inlet (45), and the second port (10) is in fluid communication with the second auxiliary container inlet (46), wherein the auxiliary concentrate recirculation path (X5) includes the auxiliary concentrate container (3), the second port (10), the second auxiliary container inlet (46), an auxiliary concentrate container outlet line (40) connecting the second auxiliary container inlet (46) to a third junction point (j3) on the main fluid line (4), at least a portion of the main fluid line (4) extending from the third junction point (j3) to a sixth junction point (j6) where a pump (8) is configured to operate thereon, an auxiliary concentrate container inlet line (37) connecting the sixth junction point (j6) on the main fluid line (4) to the first auxiliary container inlet (45), and the first port (9) of the auxiliary concentrate container (3).

[0116] In a 90th aspect according to any one of the foregoing aspects 87 to 89, the auxiliary concentrate recirculation path (X5) includes an auxiliary concentrate container outlet valve (VAO) configured to operate on the auxiliary concentrate container outlet line (40) and an auxiliary concentrate container inlet valve (VAI) configured to operate on the auxiliary concentrate container inlet line (37). When the control unit (24) controls the plurality of valves to set the second concentrate recirculation path, the auxiliary concentrate container outlet valve (VAO) and the auxiliary concentrate container inlet valve (VAI) are configured to allow fluid to recirculate in the second concentrate recirculation path. In particular, other valves among the plurality of valves configured to operate on the fluid circuit (14) that can be configured to allow fluid to enter or leave the second concentrate recirculation path are closed. Optionally, all other valves different from the auxiliary concentrate container outlet valve (VAO) and the auxiliary concentrate container inlet valve (VAI) among the plurality of valves configured to operate on the fluid circuit (14) are closed.

[0117] In a 91st aspect according to any one of the foregoing aspects, the control unit (24) is configured to operate the plurality of valves to set different fluid paths for the fluid inside the fluid circuit (14), and at least: · The mixed recirculation path (R1); and · The concentrate recirculation paths (Z6, X5), in particular the first concentrate recirculation path path (Z6) and / or the auxiliary concentrate recirculation path (X5); In particular, wherein the control unit (24) is configured to first set the concentrate recirculation paths (Z6, X5), and then set the mixed recirculation path (R1).

[0118] In a 92nd aspect according to any one of the foregoing aspects, the control unit (24) is configured to run a dry concentrate dissolution program, which includes sending a dissolution liquid (e.g., water) to at least one of the main concentrate container (2) and the auxiliary concentrate container (3) to dissolve the dry concentrate and form a liquid concentrate mixture.

[0119] In a 94th aspect according to the foregoing aspect, the dry concentrate dissolution program includes heating the dissolution liquid and / or the concentrate mixture using a heater (23). Optionally, the heater (23) is connected to the main fluid line (4). In particular, the dissolution liquid is heated to a temperature sufficient to achieve complete dissolution within a specific time period. For example, for glucose, the dissolution liquid is heated to at least 60 °C, and more specifically to at least 70 °C, and the concentrate mixture is maintained at at least 40 °C and more specifically maintained at at least 50 °C.

[0120] In aspect 95 according to either of the two foregoing aspects, the dry concentrate dissolution procedure includes a concentrate mixture recirculation step, in which the control unit (24) is configured to set a concentrate recirculation path (Z6, X5) and recirculate the concentrated mixture to homogenize it.

[0121] In aspect 96 according to either of the three foregoing aspects, the dry concentrate dissolution procedure includes one or more of the following: · An exhaust step; · A perfusion step of the main fluid line (4); · A perfusion step of the recirculation path; · A dissolution liquid filling step, optionally including a first dissolution liquid filling step and a second dissolution liquid filling step; · A concentrate mixture recirculation step; and · A concentration test step; Wherein, the control unit is configured to execute the dry concentrate dissolution procedure, which optionally includes at least an exhaust step, a dissolution liquid filling step and a concentrate mixture recirculation step, and the control unit (24) executes the three steps in a chronological order starting from the exhaust step and ending with the concentrate mixture recirculation step.

[0122] In aspect 97 according to the foregoing aspect, the control unit (24) is configured to execute the exhaust step by controlling the plurality of valves to set an exhaust flow path (Z1) to discharge air from the main concentrate container (2) and driving the pump (8) to remove air from the main concentrate container (2).

[0123] In aspect 98 according to the foregoing aspect, in the exhaust flow path (Z1), the plurality of valves are configured to allow the air contained in the main concentrate container (2) to flow into the main concentrate container outlet line (32) and into the degassing chamber (33) under the action of the pump (8). Optionally, the main concentrate container outlet valve (VGO) acting on the main concentrate container outlet line (32) and the discharge valve (VDR) acting on the discharge outlet line (30) are opened. In particular, the other valves among the plurality of valves configured to operate on the fluid circuit (14) and configurable to allow fluid to enter or leave the exhaust flow path (Z1) are closed. Optionally, all other valves different from the main concentrate container outlet valve (VGO) and the discharge valve (VDR) among the plurality of valves configured to operate on the fluid circuit (14) are closed.

[0124] In a 99th aspect according to any one of the foregoing two aspects, during the exhaust step, the control unit (24) is configured to operate the pump (8) at a preset pumping rate for a predetermined period of time and stop the pump (8) after the predetermined period of time has elapsed. It should be noted that pumping is performed until a predetermined low level in the degassing chamber is ensured.

[0125] In a 100th aspect according to any one of the foregoing four aspects, the control unit (24) is configured to perform a perfusion step of the main fluid line (4) by controlling the plurality of valves to set the main fluid line perfusion path (Z2) and by controlling the pump (8) to perfuse the main fluid line (4), particularly after the exhaust step.

[0126] In a 101st aspect according to the foregoing aspect, in the main fluid line perfusion path (Z2), the plurality of valves are configured to allow a dissolving liquid (e.g., water) to enter the main fluid line (4) and flow towards the discharge outlet line (30) under the action of the pump (8). Optionally, the water inlet valve (VWI) connected to the main fluid line (4) and the discharge valve (VDR) connected to the discharge outlet line (30) are opened. In particular, among the plurality of valves configured to operate on the fluid circuit (14), other valves that can be configured to allow fluid to enter or leave the main fluid line perfusion path (Z2) are closed. Optionally, all other valves different from the water inlet valve (VWI) and the discharge valve (VDR) among the plurality of valves configured to operate on the fluid circuit (14) are closed.

[0127] In a 102nd aspect according to any one of the foregoing two aspects, during the perfusion step of the main fluid line (4), the control unit (24) is configured to operate the pump (8) at a preset pumping rate until a predetermined pumping volume is reached and is configured to stop the pump (8) after the predetermined pumping volume has been reached. The pump (8) is operated until a predetermined volume greater than the volume of the main fluid line from the water inlet 5a to the sixth junction point j6 is achieved (in fact, for example, in the case of an empty and dry system, at the beginning, air may be present between the water inlet and the fourth junction point j4). Optionally, a safety factor z (e.g., 1.5 to 2) of the main fluid line volume is considered to ensure that no air remains between the fourth junction point j4 and the sixth junction point j6.

[0128] In a 103rd aspect according to any one of the foregoing seven aspects, the control unit (24) is configured to perform a recirculation path perfusion step by controlling the plurality of valves to set the recirculation perfusion path (Z3) and by controlling the pump (8) to perfuse the recirculation perfusion path (Z3), particularly after the exhaust step and / or the perfusion step of the main fluid line (4).

[0129] In a 104th aspect according to the foregoing aspect, in the recirculation perfusion path (Z3), the plurality of valves are configured to allow fluid to circulate from a sixth junction point (j6) on the main fluid line (4) towards the main concentrate container inlet line (31), enter the first concentrate mixing line (36), reach a fourth junction point (j4) on the main fluid line (4), enter at least a portion of the main fluid line (4) on which the pump (8) is configured to operate, extend to the sixth junction point (j6), optionally, the main concentrate container inlet valve (VGI) connected to the main concentrate container inlet line (31) and the first concentrate mixing valve (VGM) connected to the first concentrate mixing line (36) are opened, in particular, other valves among the plurality of valves configured to operate on the fluid circuit (14) and configured to allow fluid to enter or leave the recirculation perfusion path (Z3) are closed, optionally, all other valves different from the main concentrate container inlet valve (VGI) and the first concentrate mixing valve (VGM) among the plurality of valves configured to operate on the fluid circuit (14) are closed.

[0130] In a 105th aspect according to any one of the foregoing two aspects, during the recirculation path perfusion step, the control unit (24) is configured to operate the pump (8) at a preset pumping rate until a predetermined pumping volume is reached and is configured to stop the pump (8) after the predetermined pumping volume has been reached. The predetermined pumping volume for pumping is less than the volume of the main fluid line between the fourth junction point (j4) and the sixth junction point (j6), but is also greater than the volume in the remaining part of the recirculation perfusion path (Z3) (i.e., the total volume of the recirculation perfusion path minus the volume of the main fluid line between the fourth junction point (j4) and the sixth junction point (j6)). In other aspects, for example, if the volume between the fourth junction point (j4) and the sixth junction point (j6) is 80 ml and the total volume of the recirculation perfusion path (Z3) is 140 ml, the control unit will be configured to pump 60 - 80 ml (total volume Z3 – volume j4 to j6: 140 - 80 = 60 ml). If the control unit (24) is configured to pump less than 60 ml, some air will remain in the remaining part of the recirculation perfusion path (Z3). If the control unit (24) is configured to pump more than 80 ml, the control unit (24) will start to refill the remaining part of the recirculation perfusion path (Z3) with air.

[0131] In aspect 106 according to any of the foregoing ten aspects, the control unit (24) is configured to perform a first dissolved liquid filling step by controlling the plurality of valves to set a first dissolved liquid filling path (Z4) and by controlling the pump (8) to fill a part of the expected total volume of dissolved liquid in the main concentrate container (2), particularly after an exhaust step and / or after a priming step of the main fluid line (4) and / or after a recirculation path priming step.

[0132] In aspect 107 according to any of the foregoing eleven aspects, the control unit (24) is configured to: · Control a valve among the plurality of valves to set a first dissolved liquid filling path (Z4) to allow dissolved liquid to enter the main concentrate container (2), the first dissolved liquid filling path (Z4) including at least a part of the main fluid line (4) on which the pump (8) is configured to operate, a main concentrate container inlet line (31), a first port (6) of the main concentrate container (2), the main concentrate container (2), a second port (7) of the main concentrate container (2), a part of the main concentrate container outlet line (32), an optional degassing chamber (33), and a vent port (34), and optionally, an inlet water valve (VWI) placed on the main fluid line (4), a main concentrate container inlet valve (VGI) on the main concentrate container inlet line (31) and a gas valve (VGA) on the vent port (34) are opened, and in particular, other valves among the plurality of valves configured to operate on the fluid circuit (14) that can be configured to allow fluid to enter or leave the first dissolved liquid filling path (Z4) are closed; · Run a first dissolved liquid filling step to drive the pump (8) to fill a part of the expected total volume of dissolved liquid in the main concentrate container (2) through the first dissolved liquid filling path (Z4), · Optionally, determine and store a base pressure (P2_base) in the first dissolved liquid filling path (Z4), and compare a pressure-controlled filling pressure with this base pressure in a subsequent step.

[0133] In a 108th aspect according to the foregoing aspects, in a first dissolving liquid filling path (Z4), the plurality of valves are configured to allow the dissolving liquid to enter the main concentrate container (2). The first dissolving liquid filling path includes a main fluid pipeline (4), a main concentrate container inlet pipeline (31), a first port (6) of the main concentrate container (2), the main concentrate container (2), a second port (7) of the main concentrate container (2), a part of the main concentrate container outlet pipeline (32), a degassing chamber (33), and a vent (34) of the degassing chamber. Optionally, a water inlet valve (VWI) connected to the main fluid pipeline (4), a main concentrate container inlet valve (VGI) on the main concentrate container inlet pipeline (31), and a gas valve (VGA) on the vent (34) are opened. In particular, other valves among the plurality of valves configured to operate on the fluid circuit (14) and configured to allow fluid to enter or leave the first dissolving liquid filling path (Z4) are closed. Optionally, all other valves different from the water inlet valve (VWI), the main concentrate container inlet valve (VGI), and the gas valve (VGA) among the plurality of valves configured to operate on the fluid circuit (14) are closed.

[0134] In a 109th aspect according to any one of the foregoing two aspects, during the first dissolving liquid filling step, the control unit (24) is configured to: - operate the pump (8) at a preset pumping rate, and - end the first dissolving liquid filling step after the liquid level in the degassing chamber (33) reaches a preset high level.

[0135] In a 110th aspect according to any one of the foregoing three aspects, during the first dissolving liquid filling step, the control unit (24) is configured to receive pressure data in the first dissolving liquid filling path (Z4) and is configured to determine a reference pressure value (P2_base) indicating an average pressure during at least a part of the first dissolving liquid filling step. For example, the pressure can be read by a pressure sensor (P2) on the mixing container inlet pipeline, which is subject to the same pressure present in the first dissolving liquid filling path (Z4). The reference pressure value (P2_base) can be used as a reference pressure for further filling the concentrate container.

[0136] In a 111th aspect according to any one of the foregoing four aspects, during the first dissolving liquid filling step, the control unit (24) operates a heater (23) on the main fluid pipeline (4) to heat the dissolving liquid to a temperature sufficient to achieve complete dissolution within a specific time period, such as at least 70 °C and optionally up to at least 80 °C for a glucose concentrate.

[0137] In the 112th aspect according to any one of the foregoing five aspects, during the first dissolving liquid filling step, the control unit (24) is configured to receive pressure data in the first dissolving liquid filling path (Z4), and the pressure data is stored in a memory associated with the control unit (24). In particular, a reference pressure value (P2_base) is stored in the memory.

[0138] In the 113th aspect according to any one of the foregoing sixteen aspects, the control unit (24) is configured to perform a second dissolving liquid filling step by controlling the plurality of valves to set a second dissolving liquid filling path (Z5) and by controlling the pump (8) to fill the main concentrate container (2) with a total volume of dissolving liquid reaching an expected value, in particular, after the exhaust step and / or after the perfusion step of the main fluid line (4) and / or after the perfusion step of the recirculation path and / or after this first dissolving liquid filling step.

[0139] In the 114th aspect according to any one of the foregoing seventeen aspects, the control unit (24) is further configured to: · Run the second dissolving liquid filling step, driving the pump (8) to fill additional dissolving liquid into the main concentrate container (2) through the second dissolving liquid filling path (Z5), · Check the liquid level in the degassing chamber (33); · When a predetermined upper liquid level in the degassing chamber (33) is reached, interrupt the second dissolving liquid filling step.

[0140] In the 115th aspect according to the foregoing aspect, in the second dissolving liquid filling path (Z5), the plurality of valves are configured to allow the dissolving liquid to enter the main concentrate container (2). The second dissolving liquid filling path (Z5) includes the main fluid line (4), the main concentrate container inlet line (31), the first port (6) of the main concentrate container (2), the main concentrate container (2), the second port (7) of the main concentrate container (2), a part of the main concentrate container outlet line (32), the degassing chamber (33), and the vent (34) of the degassing chamber (33). Optionally, the water inlet valve (VWI) placed on the main fluid line (4) and the main concentrate container inlet valve (VGI) on the main concentrate container inlet line (31) are opened. In particular, other valves among the plurality of valves configured to operate on the fluid circuit (14) and configurable to allow fluid to enter or leave the second dissolving liquid filling path (Z5) are closed. Other valves include the gas valve (VGA) on the vent line (34) of the degassing chamber (33). Optionally, all other valves different from the water inlet valve (VWI) and the main concentrate container inlet valve (VGI) among the plurality of valves configured to operate on the fluid circuit (14) are closed.

[0141] In aspect 116 according to any one of the foregoing two aspects, during the second dissolving liquid filling step, the control unit (24) is configured to operate the pump (8) at a preset pumping rate until a predetermined pressure in the second dissolving liquid filling path (Z5) is reached and is configured to stop the pump (8) after the predetermined pressure has been reached, and the predetermined pressure is the pressure in the second dissolving liquid filling path (Z5) (in particular the reference pressure value (P2_base)) plus an overpressure value or an absolute / specific pressure.

[0142] In aspect 116 bis according to the foregoing aspects and aspect 110, the predetermined pressure is the reference pressure value (P2_base) determined during the first dissolving liquid filling step.

[0143] In aspect 117 according to any one of the foregoing three aspects, during the second dissolving liquid filling step, the control unit (24) is configured to operate the heater (23) on the main fluid line (4) to heat the dissolving liquid to a temperature sufficient to achieve complete dissolution within a specific time period, such as, for a glucose concentrate, at least 70 °C and optionally up to at least 80 °C.

[0144] In aspect 118 according to any one of the foregoing five aspects, wherein the control unit (24) is further configured to: · Run a final dissolving liquid filling step to control the pump (8) to fill additional dissolving liquid into the main concentrate container (2) through the second dissolving liquid filling path (Z5), · Measure the pressure in the second dissolving liquid filling path (Z5), · When the filling pressure for pressure control is reached, interrupt the second dissolving liquid filling step, in particular, wherein the filling pressure for pressure control corresponds to the base pressure (P2_base) plus delta, such as delta being 40 mmHg.

[0145] In aspect 119 according to any one of the foregoing twenty-three aspects, wherein the control unit (24) is configured to perform a concentrate mixture recirculation step by controlling the plurality of valves to set the concentrate recirculation path (Z6) and by controlling the pump (8) to recirculate the concentrate mixture to dissolve the dry concentrate and to uniformly mix the concentrate mixture, in particular, the concentrate mixture recirculation step is performed after the exhaust step and / or after the perfusion step of the main fluid line (4) and / or after the perfusion step of the recirculation path and / or after the first dissolving liquid filling step and / or after the second dissolving liquid filling step.

[0146] In aspect 120 according to any of the foregoing twenty-four aspects, wherein the control unit (24) is further configured to: · Control valves among the plurality of valves to set a concentrate recirculation path (Z6); · Run a concentrate mixture recirculation step (CMRS) to control the pump (8) to recirculate a liquid concentrate mixture so as to dissolve dry concentrate and uniformly mix the liquid concentrate mixture, wherein optionally, during the concentrate mixture recirculation step, the control unit (24) is configured to operate a heater (23) on the main fluid line (4) to maintain the liquid concentrate mixture flowing through the concentrate recirculation path (Z6) at a temperature within a range between 40 °C and 75 °C.

[0147] In aspect 121 according to the foregoing aspect, during the concentrate mixture recirculation step, the control unit (24) is configured to operate the pump (8) at a preset pumping rate for a predetermined period of time and is configured to stop the pump (8) after the predetermined period of time has elapsed. The combination of time and flow rate (and possibly temperature) should be selected to effectively dissolve the powder and homogenize the solution.

[0148] In aspect 122 according to any of the foregoing two aspects, during the concentrate mixture recirculation step, the control unit (24) operates the heater (23) on the main fluid line (4) to heat the concentrate mixture to a temperature sufficient to achieve complete dissolution within a specific period of time, such as, for a glucose concentrate, to at least 50 °C and optionally up to at least 60 °C. Similarly, the combination of time, flow rate, and temperature should be selected to effectively dissolve the powder and homogenize the solution.

[0149] In aspect 123 according to any of the foregoing twenty-two aspects, the control unit (24) is configured to perform a concentration test step to measure the concentration of the concentrate mixture and is configured to compare the measured concentration with the expected concentration of the concentrate mixture. Optionally, the control unit (24) is configured to measure the concentration during the concentrate mixture recirculation step.

[0150] In aspect 124 according to any of the foregoing aspects, the fluid path further includes an exhaust flow path (Z1), and in particular, the pump (8) moves fluid in the exhaust flow path (Z1).

[0151] In aspect 125 according to any of the foregoing aspects, the fluid path further includes a main fluid line priming path (Z2), and in particular, the pump (8) moves fluid in the main fluid line priming path (Z2).

[0152] In aspect 126 according to any of the foregoing aspects, the fluid path further includes a recirculation perfusion path (Z3), and in particular, a pump (8) moves the fluid in the recirculation perfusion path (Z3).

[0153] In aspect 127 according to any of the foregoing aspects, the fluid path further includes a first dissolved liquid filling path (Z4), and in particular, a pump (8) moves the fluid in the first dissolved liquid filling path (Z4).

[0154] In aspect 128 according to any of the foregoing aspects, the fluid path further includes a second dissolved liquid filling path (Z5), and in particular, a pump (8) moves the fluid in the second dissolved liquid filling path (Z5).

[0155] In aspect 129 according to any of the foregoing aspects, the control unit (24) is configured to run a liquid concentrate mixing program (LCMP), wherein the liquid concentrate mixing program (LCMP) includes sending a dilution liquid (DL) (e.g., water) to a mixing container (11) and sending a liquid concentrate (LC’, LC”) from at least one of a main concentrate container (2) and an auxiliary concentrate container (3) to the mixing container (11) to dilute the liquid concentrate (LC’, LC”) and form a dilution liquid mixture.

[0156] In aspect 130 according to the foregoing aspect, during the liquid concentrate mixing program, the control unit (24) is configured to use a heater (23) to heat the dilution liquid (DL) and / or the dilution liquid mixture (DM). Optionally, the heater (23) is placed on the main fluid line (4), wherein, in particular, the dilution liquid (DL) is heated to at least 30 °C, and more specifically to at least 37 °C, and the dilution liquid mixture (DM) is heated to at least 30 °C, and more specifically to at least 37 °C.

[0157] In aspect 131 according to any of the foregoing two aspects, during the liquid concentrate mixing program (LCMP), the control unit (24) is configured to run a dilution mixture recirculation step (RS), in which the control unit (24) is configured to set a mixing recirculation path (R1) and is configured to recirculate the dilution liquid mixture (DM) for homogenization.

[0158] In aspect 132 according to any of the foregoing aspects, the device further includes a sensor (52) connected to the main fluid line (4) to measure the properties of the fluid flowing in the main fluid line (4); the control unit (24) is configured to: · Receive from the sensor (52) the properties of the fluid flowing in the main fluid line (4) associated signals; · Recirculate the fluid in the mixing recirculation path (R1); · Detect the time-resolved change in the property of the fluid recirculated in the mixing recirculation path (R1), the time-resolved change in the property of the fluid being related to the uniformity of the fluid recirculated in the mixing recirculation path (R1); · Interrupt the recirculation step when the time-resolved change meets the change criterion.

[0159] In aspect 133 according to the foregoing aspect, the property of the fluid flowing in the main fluid line (4) is selected from the group consisting of the conductivity of the fluid flowing in the main fluid line (4), the concentration of substances in the fluid flowing in the main fluid line (4), concentration-related physical properties (such as the speed of sound, viscosity, density, the temperature of the fluid flowing in the main fluid line (4), and combinations thereof), and the optical characteristics of the fluid flowing in the main fluid line (4) (in particular, the property is conductivity or concentration).

[0160] For example, techniques based on the speed of sound / ultrasound allow the measurement of concentration. Viscosity can be indirectly measured / correlated based on the pressure drop. For example, if a positive displacement pump is used and the mass flow rate is measured, the density can be measured.

[0161] In aspect 134 according to the foregoing aspect, the sensor (52) includes at least one of a conductivity sensor, a concentration sensor, a temperature sensor, an optical sensor, and a sound sensor, and in particular, the sensor is a conductivity sensor or a concentration sensor.

[0162] In aspect 135 according to the foregoing two aspects, in order to detect the time-resolved change in the property of the fluid, the control unit (24) is configured to calculate a measure of the dispersion of the signals from the sensor, such as the change in the signals from the sensor, the standard deviation of the signals from the sensor, the range of the signals from the sensor, the interquartile range of the signals from the sensor, the mean absolute difference of the signals from the sensor, the median absolute deviation of the signals from the sensor, the mean deviation of the signals from the sensor, the trend of the signals from the sensor over time, the derivative of the signals from the sensor over time, where, in particular, the time-resolved change in the property of the fluid includes the change in the signals from the sensor.

[0163] In aspect 136 according to the foregoing three aspects, the time-resolved change meeting the change criterion includes comparing the time-resolved change in the property of the fluid with a threshold value, and in particular, the change criterion is met when the time-resolved change is below the threshold value.

[0164] In a 137th aspect according to the four foregoing aspects, the control unit (24) is configured to check whether a time-resolved change satisfies a change criterion after a predetermined time period has elapsed since the start of fluid recirculation in the hybrid recirculation path (R1), in particular the predetermined time period is not less than 20 seconds.

[0165] In a 138th aspect according to the five foregoing aspects, the sensor (52) is a conductivity meter (25) and the property of the fluid is conductivity, and the control unit (24) is configured to: - Detect a change in the conductivity of the fluid recirculated in the hybrid recirculation path (R1), - Interrupt the recirculation step after a predetermined time period has elapsed and when the change in the conductivity of the fluid is below a certain threshold (such as 0.2 mS / cm), in particular, (i) after a predetermined time period has elapsed and (ii) when the change in the conductivity of the fluid has been below the threshold for a preset time period, interrupt the recirculation step.

[0166] In a 138 bis aspect according to the six foregoing aspects, the control unit (24) is configured to check a time-resolved change in a time window, for example, the time window is a fixed time window, such as the last 10 seconds.

[0167] In a 138 ter aspect according to the foregoing aspects, the time window is a function of the volume of the hybrid recirculation path (R1) and / or the flow rate during fluid recirculation in the hybrid recirculation path (R1).

[0168] In a 138 quad aspect according to the foregoing aspects, the time window is proportional to the ratio between the volume and the flow rate, for example, the time window is: tw = const*(V / Q) where tw is the time window; const is a constant; V is the volume of the hybrid recirculation path (R1); and Q is the flow rate during fluid recirculation in the hybrid recirculation path (R1).

[0169] In a 139th aspect according to any one of the three foregoing aspects, wherein the liquid concentrate mixing program (LCMP) includes one or more of the following: · Mixing container discharge step (MCDS); · Mixing container filling step for flushing (MCFS); · Perfusion step of the main fluid pipeline (PSMF); · A first filling step (FS’) of filling an auxiliary liquid concentrate (LC’) from an auxiliary concentrate container (3) into a mixing container (11); · A water filling step (FSW); · A first recirculation step (RS’) of a first diluted liquid mixture (DM’); · Another water filling step (FSW); · A second recirculation step (RS’) of the first diluted liquid mixture (DM’) with added water; · A second filling step (FS”) of filling a main liquid concentrate (LC”) reached from a main concentrate container (2) into the mixing container (11) to form a dialysis mixture (DiaM); · A second recirculation step (RS”) of the dialysis mixture (DiaM) to form a dialysis fluid (DF).

[0170] In aspect 140 according to the foregoing aspect, the control unit (24) is configured to perform a mixing container discharge step (MCDS) by controlling the plurality of valves to set a mixing container discharge path (Y1) to allow discharge of the mixing container (11) and by controlling a pump (8) to move fluid from the mixing container (11) through an outlet (13), at least a portion of a main fluid line (4) on which the pump (8) is configured to operate, a discharge outlet line (30), and to a discharge port (29).

[0171] In aspect 141 according to the foregoing aspect, the mixing container discharge path (Y1) includes the mixing container (11), an outlet (13), a mixing container outlet line (16) connecting the outlet (13) of the mixing container (11) to a first junction point (j1) on the main fluid line (4), at least a portion of the main fluid line (4) on which the pump (8) is configured to operate extending between the first junction point (j1) and a sixth junction point (j6), a discharge outlet line (30) from the sixth junction point (j6) to the discharge port (29), and the discharge port (29).

[0172] In aspect 142 according to the foregoing aspects, the mixing vessel discharge path (Y1) includes a mixing vessel outlet valve (VMO) configured to operate on the mixing vessel outlet line (16) and a discharge valve (VDR) configured to operate on the discharge outlet line (30). When the control unit (24) controls the plurality of valves to set the mixing vessel discharge path (Y1), the mixing vessel outlet valve (VMO) and the discharge valve (VDR) are configured to allow fluid to flow from the mixing vessel (11) to the discharge port (29). In particular, other valves among the plurality of valves configured to operate on the fluid circuit (14) and configurable to allow fluid to enter or leave the mixing vessel discharge path (Y1) are closed. Optionally, all other valves among the plurality of valves configured to operate on the fluid circuit (14) and different from the mixing vessel outlet valve (VMO) and the discharge valve (VDR) are closed.

[0173] In aspect 143 according to any one of the foregoing three aspects, the control unit (24) is configured to operate the plurality of valves to set the mixing vessel discharge path (Y1). In particular, the control unit (24) is configured to first set the mixing vessel discharge path (Y1) before defining the first concentrate recirculation path (Z6) and / or the second concentrate recirculation path (X5).

[0174] In aspect 144 according to any one of the foregoing four aspects, during the mixing vessel discharge step (MCDS), especially when the mixing vessel (11) is a flexible mixing vessel, the control unit (24) is configured to operate the pump (8) at a preset pumping rate and is configured to stop the pump (8) when a predetermined pressure in the mixing vessel discharge path (Y1) has been reached. Optionally, the preset pressure is equal to or lower than a value indicating an empty mixing vessel, such as -100 mmHg.

[0175] In aspect 144 bis according to any one of the foregoing four aspects, during the mixing vessel discharge step (MCDS), the control unit (24) is configured to operate the pump (8) at a preset pumping rate and is configured to stop the pump (8) when a sensor (52) on the main fluid line (4), such as a conductivity meter (25), senses the presence of air in the main fluid line (4).

[0176] In aspect 145 according to any one of the foregoing six aspects, the control unit (24) is configured to perform a mixing container filling step for flushing (MCFS) by controlling a valve among the plurality of valves to set a mixing container filling path (Y2) to flush at least a mixing container inlet line (15) and a mixing container (11). During the mixing container filling step for flushing (MCFS), the control unit (24) is configured to control a pump (8) to move fluid from at least a part of a main fluid line (4) on which the pump (8) is configured to operate to the mixing container inlet line (15) and the mixing container (11). In particular, it moves from an inlet point (5) of the main fluid line (4) of the fluid circuit (14) to the mixing container inlet line (15) and the mixing container (11).

[0177] In aspect 146 according to any one of the foregoing aspects, the mixing container filling path (Y2) includes at least a part of the main fluid line (4) of the fluid circuit (14) (in particular, the entire main fluid line (4) of the fluid circuit (14) on which the pump (8) is configured to operate), a sixth junction point (j6), a mixing container inlet line (15), and a mixing container (11).

[0178] In aspect 147 according to any one of the foregoing two aspects, the mixing container filling path (Y2) includes a water inlet valve (VWI) configured to operate on the main fluid line (4) and a mixing container inlet valve (VMI) configured to operate on the mixing inlet line (15). When the control unit (24) controls the plurality of valves to set the mixing container filling path (Y2), at least the water inlet valve (VWI) and the mixing container inlet valve (VMI) are opened to allow fluid to flow from the main fluid line (4) to the mixing container (11). Optionally, other valves (except the air valve (22), if present) among the plurality of valves configured to operate on the fluid circuit (14) and capable of allowing fluid to enter or leave the mixing container filling path (Y2) are closed. Preferably, all other valves different from the water inlet valve (VWI) and the mixing container inlet valve (VMI) among the plurality of valves configured to operate on the fluid circuit (14) are closed. In the case where the mixing container (11) is a rigid container having a vent hole and a corresponding air valve (22), the air valve (22) should also be opened to allow air to be discharged during filling.

[0179] In aspect 148 according to any one of the foregoing three aspects, during the mixing container filling step (MCFS) for flushing, the control unit (24) is configured to operate the pump (8) at a preset pumping rate until a predetermined pumping volume is reached and is configured to stop the pump (8) after the predetermined pumping volume has been reached. Optionally, the predetermined pumping volume is sufficient to effect proper flushing of the main fluid line (4) and the mixing container (11).

[0180] In aspect 149 according to any one of the foregoing four aspects, the mixing container filling step (MCFS) for flushing includes a mixing container emptying step (MCES), wherein the control unit (24) is configured to control a valve among the plurality of valves to set a mixing container emptying path to flush at least the mixing container outlet line (16), and the control unit (24) is further configured to control the pump (8) to move fluid from the mixing container (11) to the discharge outlet line (30) and the discharge port (29).

[0181] In aspect 150 according to the foregoing aspect, the mixing container emptying path includes the mixing container outlet line (16), a first junction point (j1) on the main fluid line (4), at least a portion of the main fluid line (4), a sixth junction point (j6), the discharge outlet line (30), and the discharge port (29).

[0182] In aspect 151 according to any one of the foregoing two aspects, the mixing container emptying path includes a mixing container outlet valve (VMO) configured to operate on the mixing container outlet line (16) and a discharge valve (VDR) configured to operate on the discharge outlet line. When the control unit (24) controls the plurality of valves to set the mixing container emptying path, at least the mixing container outlet valve (VMO) and the discharge valve (VDR) are opened so that fluid flows from the mixing container (11) to the discharge port (29). Optionally, other valves among the plurality of valves configured to operate on the fluid circuit (14) and configured to allow fluid to enter or leave the mixing container emptying path are closed. Preferably, all other valves among the plurality of valves configured to operate on the fluid circuit (14) and different from the water inlet valve (VWI) and the mixing container inlet valve (VMI) are closed.

[0183] In aspect 152 according to any one of the foregoing three aspects, the control unit (24) is configured to perform the mixing container emptying step (MCES) after the mixing container filling step (MCFS) for flushing.

[0184] In aspect 153 according to any one of the four foregoing aspects, during the mixing container emptying step (MCES), in particular when the mixing container (11) is a flexible mixing container, the control unit (24) is configured to operate the pump (8) at a preset pumping rate and is configured to stop the pump (8) when a predetermined pressure has been reached in the mixing container emptying path.

[0185] In aspect 153 according to any one of the five foregoing aspects, during the mixing container emptying step (MCES), the control unit (24) is configured to operate the pump (8) at a preset pumping rate and is configured to stop the pump (8) when a sensor (52) (such as a conductivity meter (25)) on the main fluid line (4) senses the presence of air in the main fluid line (4).

[0186] In aspect 154 according to any one of the fifteen foregoing aspects, the control unit (24) is configured to flush the main fluid line (4) by controlling the valves in the plurality of valves to set the main fluid perfusion path and to perform the perfusion step of the main fluid line (PSMF) by controlling the pump (8) to move the fluid from the inlet point (5) at least to the discharge outlet line (30).

[0187] In aspect 155 according to the foregoing aspect, the main fluid perfusion path includes at least a part of the main fluid line (4), in particular the entire main fluid line (4) of the fluid circuit (14) on which the pump (8) is configured to operate. The main fluid perfusion path is formed between the inlet point (5) and the outlet discharge line (30), specifically, between the inlet point (5) and the discharge port (29).

[0188] In aspect 156 according to any one of the two foregoing aspects, the main fluid perfusion path includes a water inlet valve (VWI) configured to operate on the main fluid line (4) and a discharge valve (VDR) configured to operate on the outlet discharge line (30). When the control unit (24) controls the plurality of valves to set the main fluid perfusion path, at least the water inlet valve (VWI) and the discharge valve (VDR) are opened to allow the fluid to flow from the fluid main line (4) to the discharge outlet line (30). Optionally, other valves among the plurality of valves configured to operate on the fluid circuit (14) and configured to allow the fluid to enter or leave the main fluid perfusion path are closed. Preferably, all other valves different from the water inlet valve (VWI) and the discharge valve (VDR) among the plurality of valves configured to operate on the fluid circuit (14) are closed.

[0189] In aspect 157 according to any one of the foregoing three aspects, during the perfusion step of the primary stream line (PSMF), the control unit (24) is configured to operate the pump (8) at a preset pumping rate and until a predetermined period of time has elapsed. The pump (8) operates at least until the volume contained between the first joint (j1) and the sixth joint (j6) has been pumped, in particular with the aim of making any remaining conductivity low enough so as not to significantly affect the ingredient accuracy in the following steps.

[0190] In aspect 158 according to the foregoing aspect, during the perfusion step of the primary stream line (PSMF), the control unit (24) operates the heater (23) on the primary stream line (4) to heat the fluid flowing through the primary stream perfusion path to 37 °C.

[0191] In aspect 159 according to any one of the foregoing two aspects, the control unit (24) is configured to perform a primary stream line concentration test step (MF-CTS) to measure the concentration value of the fluid flowing through the primary stream perfusion path, and is configured to compare the concentration value measured in the fluid flowing through the primary stream perfusion path with a concentration reference value, which concentration reference value does not exceed 0.2 mS / cm in particular, preferably does not exceed 0.15 mS / cm, and optionally, the control unit is configured to end the perfusion step of the primary stream line when the conductivity is lower than a predetermined threshold value (such as 0.2 mS / cm).

[0192] In aspect 160 according to any one of the foregoing six aspects, the control unit (24) is configured to perform the perfusion step (PSMF) of the primary stream line after the mixing container filling step (MCFS) and / or the mixing container emptying step (MCES) for flushing.

[0193] In aspect 161 according to any one of the foregoing aspects, the control unit (24) is configured to perform a first filling step (FS') of the auxiliary liquid concentrate (LC') by controlling the valve in the plurality of valves to set the auxiliary concentrate filling path (F1), so as to supply the auxiliary liquid concentrate (LC') to the mixing container (11) during the first filling step (FS') of the auxiliary liquid concentrate (LC'), in particular according to a predetermined nominal volume, and the control unit (24) is configured to operate the pump (8) to move the auxiliary liquid concentrate (LC') from the corresponding concentrate containers 2, 3, in particular from the auxiliary concentrate container (3) to the mixing container (11).

[0194] In a 162nd aspect according to the foregoing aspects, the auxiliary concentrate filling path (F1) includes a second concentrate mixing pipeline (41), a second junction point (j2), at least a part of the main fluid pipeline (4) in which the pump (8) is configured to operate, a sixth junction point (j6), a mixing container mixing pipeline (15), an inlet (12) of the mixing container (11), and the mixing container (11).

[0195] In a 163rd aspect according to any one of the foregoing two aspects, the auxiliary concentrate filling path (F1) includes a second concentrate mixing valve (VAM) configured to operate on the second concentrate mixing pipeline (41) and a mixing container inlet valve (VMI) configured to operate on the mixing inlet pipeline (15). When the control unit (24) controls the plurality of valves to set the auxiliary concentrate filling path (F1), the second concentrate mixing valve (VAM) and the mixing container inlet valve (VMI) are opened to move the auxiliary liquid concentrate (LC’) of the auxiliary concentrate container (3) to the mixing container (11). Optionally, other valves among the plurality of valves configured to operate on the fluid circuit (14) and configured to allow fluid to enter or leave the auxiliary concentrate filling path (F1) are closed. Preferably, all other valves among the plurality of valves configured to operate on the fluid circuit (14) and different from the mixing container inlet valve (VMI) and the mixing container inlet valve (VMI) are closed.

[0196] In a 164th aspect according to the foregoing 161st aspect, the auxiliary concentrate filling path (F1) includes an auxiliary concentrate container outlet pipeline (40), a third junction point (j3), at least a part of the main fluid pipeline (4) in which the pump (8) is configured to operate, a sixth junction point (j6), a mixing container mixing pipeline (15), an inlet (12) of the mixing container (11), and the mixing container (11).

[0197] In aspect 165 according to any of the foregoing aspects, the auxiliary concentrate filling path (F1) includes an auxiliary concentrate container outlet valve (VAO) configured to operate at the auxiliary concentrate container outlet (40) and a mixing container inlet valve (VMI) configured to operate on the mixing inlet line (15). When the control unit (24) controls the plurality of valves to set the auxiliary concentrate filling path (F1), the auxiliary concentrate container outlet valve (VAO) and the mixing container inlet valve (VMI) are opened to move the auxiliary concentrate of the auxiliary concentrate container (3) to the mixing container (11). Optionally, other valves among the plurality of valves configured to operate on the fluid circuit (14) and configurable to allow fluid to enter or leave the auxiliary concentrate filling path (F1) are closed. Preferably, all other valves among the plurality of valves configured to operate on the fluid circuit (14) and different from the auxiliary concentrate container outlet valve (VAO) and the mixing container inlet valve (VMI) are closed.

[0198] In aspect 166 according to any of the foregoing five aspects, during the first filling step (FS') of the auxiliary liquid concentrate (LC'), the control unit (24) is configured to operate the pump (8) at a preset pumping rate until a predetermined pumping volume is reached, and is configured to stop the pump (8) after the predetermined pumping volume has been reached. The predetermined pumping volume is selected to fill the mixing container (11) with a nominal volume of the auxiliary liquid concentrate (LC') according to the medical fluid components to be prepared.

[0199] In aspect 167 according to any of the foregoing six aspects, during the first filling step (FS') of the auxiliary liquid concentrate (LC'), the control unit (24) is configured to operate the heater (23) on the main fluid line (4) to heat the auxiliary liquid concentrate (LC') flowing through the auxiliary concentrate filling path (F1) to, for example, 37 °C.

[0200] In aspect 168 according to any of the foregoing seven aspects, the control unit (24) is configured to perform the first filling step (FS') of the auxiliary liquid concentrate (LC') after the mixing container discharge step MCDS and / or after the mixing container filling step (MCFS) for rinsing and / or after the mixing container emptying step (MCES) and / or after the perfusion step (PSMF) of the main fluid line.

[0201] In aspect 169 according to any one of the six foregoing aspects, a water filling step (FSW) follows the filling step (FS’) of the auxiliary liquid concentrate (LC’), wherein the control unit (24) is configured to control a valve among the plurality of valves to set a water filling path (W1) such that the mixing container (11) is filled with at least a predetermined volume of water, and the control unit (24) is configured to control the pump (8) to cause water to flow from the inlet point (5) of the fluid circuit (14) to the mixing container (11).

[0202] In aspect 170 according to the foregoing aspect, the water filling path (FSW) includes at least a part of the main fluid line (4) (especially the part formed between the inlet point (5) of the fluid circuit (14) and the sixth junction point (j6)), the sixth junction point (j6), the mixing container inlet line (15), the inlet (12) of the mixing container (11), and the mixing container (11).

[0203] In aspect 171 according to any one of the two foregoing aspects, the water filling path (W1) includes a water inlet valve (VWI) configured to operate on the fluid main line (4) and a mixing container inlet valve (VMI) configured to operate on the mixing inlet line (15). When the control unit (24) controls the plurality of valves to set the water filling path (W1), the water inlet valve (VWI) and the mixing container inlet valve (VMI) are opened to allow water from the inlet point (5) of the fluid circuit (14) to flow to the mixing container (11). Optionally, other valves among the plurality of valves configured to operate on the fluid circuit (14) and configurable to allow fluid to enter or leave the water filling path (W1) are closed. Preferably, all other valves different from the water inlet valve (VWI) and the mixing container inlet valve (VMI) among the plurality of valves configured to operate on the fluid circuit (14) are closed.

[0204] In aspect 172 according to any one of the three foregoing aspects, during the water filling step (FSW), the control unit (24) is configured to operate the pump (8) at a preset pumping rate until a predetermined pumping volume is reached, and is configured to stop the pump (8) after the predetermined pumping volume has been reached.

[0205] In aspect 173 according to the foregoing aspect, the control unit (24) is configured to determine the dead volume of water and is configured to correct the predetermined pumping volume to at least 80% of the calculated reference volume of water minus the dead volume of water.

[0206] In a 174th aspect according to the foregoing 172nd or 173rd aspect, a calculated reference volume of water is obtained by subtracting the dead volume of water from a predetermined nominal volume of water. In particular, the dead volume is defined by the volume of water remaining in the fluid circuit (14), optionally defined by the volume of water remaining in the mixing container discharge path Y1 and / or the mixing container filling path Y2 and / or the mixing container emptying path and / or the main fluid perfusion path.

[0207] In a 175th aspect according to any one of the foregoing three aspects, during the water filling step, the control unit (24) is configured to operate the heater (23) on the main fluid line (4) to heat the water flowing through the water filling path to a temperature suitable for conductivity sensing, for example, 37 °C. Since temperature affects the conductivity sensor reading, the heater raises the water temperature to a value that allows for accurate conductivity measurement.

[0208] In a 176th aspect according to any one of the foregoing seven aspects, in a first recirculation step (RS') of adding a first diluted liquid mixture (DM') of water, the control unit (24) is configured to operate a valve among the plurality of valves to set a mixing recirculation path (R1) so as to mix and fill the first diluted liquid mixture (DM') of added water into the mixing container (11). During the first recirculation filling step (RS') of adding the first diluted liquid mixture (DM') of water, the control unit (24) is configured to operate the pump (8) to cause the first diluted liquid mixture of added water to flow through the mixing recirculation path (R1).

[0209] In a 177th aspect according to the foregoing aspect, the mixing recirculation path (R1) includes the mixing container (11), the outlet (13) of the mixing container (11), the mixing container outlet line (16) and the first junction point (j1), at least a part of the main fluid line (4) in which the pump (8) is configured to operate (in particular, the part formed between the first junction point (j1) and the sixth junction point (j6)), the sixth junction point (j6) and the mixing container inlet line (15).

[0210] In aspect 178 according to any one of the foregoing two aspects, the mixing recirculation path (R1) includes a mixing vessel outlet valve (VMO) and a mixing vessel inlet valve (VMI), wherein the control unit (24) is configured to control the plurality of valves to set the mixing recirculation path (R1), the mixing vessel outlet valve (VMO) and the mixing vessel inlet valve (VMI) are opened to allow a first dilution liquid mixture (DM’) to flow through the mixing recirculation path (R1), optionally, other valves among the plurality of valves configured to operate on the fluid circuit (14) and configured to allow fluid to enter or leave the mixing recirculation path are closed, preferably, all other valves different from the mixing vessel outlet valve (VMO) and the mixing vessel inlet valve (VMI) among the plurality of valves configured to operate on the fluid circuit (14) are closed.

[0211] In aspect 179 according to any one of the foregoing three aspects, during a first recirculation step (RS’) of the first dilution liquid mixture (DM’), the control unit (24) is configured to operate the pump (8) at a preset pumping rate and at least a predetermined period of time has elapsed. In particular, the pump (8) runs until at least the volume contained between the mixing vessel outlet (13) and the sixth junction point (j6) is pumped. Another requirement before stopping the pump 8 may be one of the subsequent aspects 181.

[0212] In aspect 180 according to the foregoing aspect, during a first recirculation step (RS’) of the first dilution liquid mixture (DM’), the control unit (24) is configured to operate the heater (23) on the main fluid line (4) to heat the first dilution liquid mixture (DM’) to a temperature suitable for conductivity sensing, for example, 37 °C.

[0213] In aspect 181 according to any one of the foregoing two aspects, the control unit (24) is configured to perform another main fluid line concentration test step (MF-CTS’) to preferably continuously detect the change in conductivity of the first dilution liquid mixture (DM’) flowing through the mixing recirculation path (R1) by using at least one conductivity meter (25, 26). Optionally, the control unit (24) is configured to compare the change in conductivity detected in the first dilution liquid mixture (DM’) flowing through the mixing recirculation path (R1) with a predetermined threshold, and when it is below the predetermined threshold, send a signal to interrupt the first recirculation step (RS’) of the first dilution liquid mixture (DM’).

[0214] In aspect 182 according to any one of the foregoing six aspects, the water filling step (FSW) and the first recirculation step (RS’) of the first dilution liquid mixture (DM’) are repeated at least once.

[0215] In an 183rd aspect according to the foregoing aspects, during the repeated water filling step (FSW), the control unit (24) is configured to operate the pump (8) at a preset pumping rate until a predetermined pumping volume is reached and is configured to stop the pump (8) after the predetermined pumping volume has been reached. Optionally, the predetermined pumping volume is equal to or higher than the recalculated reference volume of water.

[0216] In an 184th aspect according to any one of the foregoing two aspects, during the repeated water filling step (FSW), the control unit (24) is configured to operate the heater (23) on the main fluid line (4) to heat the water and / or the first dilution liquid mixture (DM') of added water flowing through the water filling path and / or the mixing recirculation path (R1) to a value that allows for accurate conductivity measurement, for example, 37 °C.

[0217] In an 185th aspect according to any one of the foregoing three aspects, during the first recirculation step (R1) of the repeated addition of the first dilution liquid mixture (DM') of added water, the control unit (24) is configured to operate the pump (8) at a preset pumping rate and for at least a predetermined period of time. In particular, the pump (8) runs until at least the volume contained between the first joint (j1) and the sixth joint (j6) has been pumped. Another requirement before stopping the pump 8 can be one of the subsequent aspects 187.

[0218] In an 186th aspect according to the foregoing aspects, during the first recirculation step (RS') of the repeated addition of the first dilution liquid mixture (DM') of added water, the control unit (24) is configured to operate the heater (23) on the main fluid line (4) to heat the first dilution liquid mixture (DM') of added water to a value that allows for accurate conductivity measurement, for example, 37 °C.

[0219] In an 187th aspect according to any one of the foregoing two aspects, the control unit (24) is configured to perform another main fluid line concentration test step (MF-CTS') to preferably continuously detect the change in conductivity of the first dilution liquid mixture (DM') of added water flowing through the mixing recirculation path (R1) using at least one conductivity meter (25, 26). Optionally, the control unit (24) is configured to compare the change in conductivity detected in the first dilution liquid mixture (DM') of added water flowing through the mixing recirculation path (R1) with a predetermined threshold, and when below the predetermined threshold, issue a signal to interrupt the first recirculation step (RS') of the repeated addition of the first dilution liquid mixture (DM') of added water.

[0220] In an 188th aspect according to any one of the foregoing twelve aspects, in a second filling step (FS”) of a main liquid concentrate (LC”) for forming a dialysis mixture (DiaM), a control unit (24) is configured to control valves among the plurality of valves to set a main concentrate filling path (F2) to fill a mixing container (11) with the main liquid concentrate (LC”), in particular according to a predetermined nominal volume. In the filling step of the main liquid concentrate, the control unit (24) is further configured to control a pump (8) to move the main liquid concentrate (LC”) to the mixing container (11).

[0221] In a 189th aspect according to the foregoing aspect, the main concentrate filling path (F2) includes a first concentrate mixing pipeline (36), a fourth junction point (j4), at least a part of a main fluid pipeline (4) in which the pump (8) is configured to operate, a sixth junction point (j6), a mixing container mixing pipeline (15), an inlet (12) of the mixing container (11), and the mixing container (11).

[0222] In a 190th aspect according to any one of the foregoing two aspects, the main concentrate filling path (F2) includes a first concentrate mixing valve (VGM) configured to operate on the first concentrate mixing pipeline (36) and a mixing container inlet valve (VMI) configured to operate on the mixing inlet pipeline (15). When the control unit (24) controls the plurality of valves to set the main concentrate filling path (F2), the first concentrate mixing valve (VGM) and the mixing container inlet valve (VMI) are opened to move the main liquid concentrate (LC”) from the main concentrate container (2) to the mixing container (11). Optionally, other valves among the plurality of valves configured to operate on the fluid circuit (14) and capable of being configured to allow fluid to enter or leave the main concentrate filling path (F2) are closed. Preferably, all other valves among the plurality of valves configured to operate on the fluid circuit (14) and different from the first concentrate mixing valve (VGM) and the mixing container inlet valve (VMI) are closed.

[0223] In a 191st aspect according to any one of the foregoing 188th aspects, the main concentrate filling path (F2) includes a main concentrate container outlet pipeline (32), a fifth junction point (j5), at least a part of a main fluid pipeline (4) in which the pump (8) is configured to operate, a sixth junction point (j6), a mixing container mixing pipeline (15), an inlet (12) of the mixing container (11), and the mixing container (11).

[0224] In aspect 192 according to the foregoing aspects, the main concentrate filling path (F2) includes a main concentrate container outlet valve (VGO) configured to operate on the main concentrate container outlet (32) and a mixing container inlet valve (VMI) configured to operate on the mixing inlet line (15). When the control unit (24) controls the plurality of valves to set the main concentrate filling path (F2), the main concentrate container outlet valve (VGO) and the mixing container inlet valve (VMI) are opened to move the main liquid concentrate (LC”) from the main concentrate container (2) to the mixing container (11). Optionally, other valves among the plurality of valves configured to operate on the fluid circuit (14) and configured to allow fluid to enter or leave the main concentrate filling path (F2) are closed. Preferably, all other valves among the plurality of valves configured to operate on the fluid circuit (14) and different from the main concentrate container outlet valve (VGO) and the mixing container inlet valve (VMI) are closed.

[0225] In aspect 193 according to any one of the foregoing five aspects, during the second filling step (FS”) of the main liquid concentrate (LC”), the control unit (24) is configured to operate the pump (8) at a preset pumping rate until a predetermined pumping volume is reached and is configured to stop the pump (8) when the predetermined pumping volume has been reached. Optionally, the predetermined pumping volume is equal to or higher than the recalculated reference volume of the main liquid concentrate (LC”).

[0226] In aspect 194 according to any one of the foregoing six aspects, during the second filling step (FS”) of the main liquid concentrate (LC”), the control unit (24) is configured to operate the heater (23) on the main fluid line (4) to heat the main liquid concentrate (LC”) flowing through the main concentrate filling path to a temperature suitable for conductivity sensing, for example, 37 °C.

[0227] In aspect 195 according to any one of the foregoing seven aspects, the control unit (24) is configured to perform the second filling step (FS”) of the main liquid concentrate (LC”) after the first recirculation step (RS’) of the first diluted liquid mixture (DM’) with added water and / or after the repeated filling step FSW of water and / or after the repeated first recirculation step RS of the first diluted liquid mixture (DM’).

[0228] In aspect 196 according to any one of the foregoing eight aspects, after the second filling step of the main liquid concentrate (LC”), there is at least one second recirculation step (RS”) of a dialysis mixture (DiaM) formed by adding the main liquid concentrate (LC”) to a first dilution liquid mixture (DM”) in a mixing container (11). During the second recirculation step (RS”) of the dialysis mixture (DiaM), the control unit (24) is configured to control valves among the plurality of valves to set a mixing recirculation path, and the mixing recirculation path allows the dialysis mixture (DiaM) to mix and form a dialysis fluid (FD). During the second recirculation step (RS”) of the dialysis mixture (DiaM), the control unit (24) is further configured to operate the pump (8) to cause the dialysis mixture (DiaM) to flow through the mixing recirculation path.

[0229] In aspect 197 according to the foregoing aspect, the mixing recirculation path includes a mixing container (11), an outlet (13) of the mixing container (11), a mixing container outlet line (16), and a first junction point (j1), at least a part of the main fluid line (4) (in particular, a part formed between the first junction point (j1) and the sixth junction point (j6)) in which the pump (8) is configured to operate, the sixth junction point (j6), a mixing container inlet line (15), and an inlet (12).

[0230] In aspect 198 according to any one of the foregoing two aspects, the mixing recirculation path includes a mixing container outlet valve (VMO) configured to operate on the mixing outlet line (16) and a mixing container inlet valve (VMI) configured to operate on the mixing inlet line (15). When the control unit (24) controls the plurality of valves to set the mixing recirculation path, the mixing container outlet valve (VMO) and the mixing container inlet valve (VMI) are opened to allow the dialysis fluid to flow through the mixing recirculation path. Optionally, other valves among the plurality of valves configured to operate on the fluid circuit (14) and configured to allow fluid to enter or leave the mixing recirculation path are closed. Preferably, all other valves among the plurality of valves configured to operate on the fluid circuit (14) and different from the mixing container outlet valve (VMO) and the mixing container inlet valve (VMI) are closed.

[0231] In aspect 199 according to any one of the foregoing three aspects, during the second recirculation step (RS”) of the dialysis mixture (DiaM), the control unit (24) is configured to operate the pump (8) at a preset pumping rate and for at least a predetermined period of time. In particular, the pump (8) runs until at least the volume contained between the first junction point (j1) and the sixth junction point (j6) has been pumped. Another requirement before stopping the pump 8 may be one of the subsequent aspects 201.

[0232] In the 200th aspect according to the foregoing aspect, during the recirculation step (RS”) of the dialysis mixture (DiaM), the control unit (24) is configured to operate the heater (23) on the main fluid line (4) to heat the dialysis mixture (DiaM) to a temperature suitable for conductivity sensing, for example, 37 °C.

[0233] In the 201st aspect according to any one of the foregoing two aspects, the control unit (24) is configured to perform an additional main fluid line concentration test step (MF-CTS”) to preferably continuously detect, by means of at least one conductivity meter (25, 26), the change in the conductivity of the dialysis mixture (DiaM) flowing through the mixing recirculation path. Optionally, the control unit (24) is configured to compare the detected change in the conductivity of the dialysis mixture (DiaM) with a predetermined threshold value, and when it is below the predetermined threshold value, issue a signal to interrupt the second recirculation step (RS”) of the dialysis mixture (DiaM).

[0234] In the 202nd aspect according to any one of the foregoing aspects, the auxiliary concentrate container (3) in fluid communication with the first auxiliary container inlets (45, 46) contains an auxiliary liquid concentrate (LC’), wherein the control unit (24) is configured to: · Control the valves among the plurality of valves to set the auxiliary concentrate filling path (F1), thereby allowing the mixing container (11) to be filled with the auxiliary liquid concentrate (LC’); · Run the first filling step (FS’) of the auxiliary liquid concentrate (LC’) to fill the mixing container (11) with the auxiliary liquid concentrate (LC’), particularly according to a predetermined nominal volume; · Control the valves among the plurality of valves to set the water filling path (W1), thereby allowing water to fill the mixing container (11); · Run the filling step (FSW) of water to fill the mixing container (11) with water, particularly according to a predetermined nominal water volume. Optionally, during the filling step of water, the control unit (24) is configured to operate the heater (23) on the main fluid line (4) to maintain the water flowing through the water filling path (W1) within a temperature range between 30 °C and 45 °C.

[0235] In the 203rd aspect according to the foregoing aspect, before running the first filling step (FS’), the control unit (24) is configured to: · Control the valves among the plurality of valves to set the mixing container discharge path (Y1), thereby allowing discharge Empty mixing container (11); · Run a mixing container evacuation step (MCES) to evacuate the fluid contained therein from the mixing container (11); · Contain the fluid; · Control the valves in the plurality of valves to set a main fluid line perfusion path (Z2), thereby allowing Flush the main fluid line (4); · Run a perfusion step (MFPS) of the main fluid line to perfuse the main fluid line (4); · After a predetermined period of time has elapsed and / or after the properties of the fluid flowing in the main fluid line (4) measured by the sensor (52) match the perfusion standard, interrupt the perfusion step (MFPS) of the main fluid line.

[0236] In the 204th aspect according to the foregoing aspects, during the perfusion step (MFPS) of the main fluid line, water remains in the main fluid line (4), wherein when the filling step (FSW) of the water is run, the control unit (24) is configured to control the pump (8) to fill the mixing container (11) with the predetermined nominal water volume and is configured to determine the predetermined nominal water volume in consideration of the amount of water already contained in the main fluid line (4).

[0237] In the 205th aspect according to any one of the foregoing three aspects, the control unit (24) is configured to run a first recirculation step (RS'), including: - Being able to operate the plurality of valves to configure a mixing recirculation path (R1); - Being able to operate the pump (8) to recirculate the recirculation fluid in the mixing recirculation path (R1), the recirculation fluid including an auxiliary liquid concentrate (LC') and the water filled into the mixing container (11); Wherein the control unit (24) is further configured to perform a fluid uniform mixing test step (MF-CTS'), which includes the detection of the time-resolved change of the properties of the fluid recirculated in the mixing recirculation path (R1) and the interruption of the first recirculation step.

[0238] In the 206th aspect according to any one of the foregoing four aspects, the control unit (24) is configured to: - Measure the properties of the fluid flowing in the main fluid line (4) during the recirculation of the fluid in the mixing recirculation path (R1); - Control the valves in the plurality of valves to set a water filling path (W1), thereby allowing the mixing container (11) to be filled with water; - Run an additional water filling step to fill the mixing container (11) with additional water, in particular with a volume of water calculated according to said metric based on the properties of the fluid during fluid recirculation; - Optionally, control the valves among the plurality of valves to set a mixing recirculation path (R1) and recirculate the previously mixed auxiliary liquid concentrate (LC') and water with additional water in a second recirculation step, wherein the control unit (24) is further configured to perform an additional fluid homogeneous mixing test step (MF-CTS'), which includes said detection of the time-resolved change of the properties of the fluid recirculated in the mixing recirculation path (R1) and the interruption of the second recirculation step.

[0239] In aspect 207 according to any one of the foregoing five aspects, the main concentrate container (2) in fluid communication with the first main container inlet (43) contains a main liquid concentrate (LC''), wherein the control unit (24) is configured to: - Control the valves among the plurality of valves to set a main concentrate filling path (F2) to allow the mixing container (11) to be filled with the main liquid concentrate (LC''); - Run a second filling step (FS'') of the main liquid concentrate (LC'') to fill the mixing container (11) with the main liquid concentrate (LC''), in particular with a calculated volume, wherein optionally, during the second filling step of the main liquid concentrate (LC''), the control unit (24) is configured to operate the heater (23) on the main fluid line (4) to maintain the water flowing through the main concentrate filling path (F2) at a temperature within the range between 30 °C and 45 °C.

[0240] In aspect 208 according to the foregoing aspect, the control unit (24) is configured to run a final recirculation step (RS'), including: - Being able to operate the plurality of valves to configure a mixing recirculation path (R1); - Being able to operate the pump (8) to recirculate the recirculating fluid in the mixing recirculation path (R1) to form a dialysis mixture (DiaM), the recirculating fluid including the auxiliary liquid concentrate (LC'), the main liquid concentrate (LC'') and the water filled into the mixing container (11); wherein the control unit (24) is further configured to perform a final fluid homogeneous mixing test step (MF-CTS''), which includes said detection of the time-resolved change of the properties of the fluid recirculated in the mixing recirculation path (R1) and the interruption of the final recirculation step.

[0241] In a 209th aspect according to any of the foregoing aspects, the control unit (24) is configured to run a dry concentrate dissolution program, where the dry concentrate dissolution program includes: - Sending a dissolution liquid (e.g., water) to at least one of the main concentrate container (2) and the auxiliary concentrate container (3) to dissolve the dry concentrate and form a concentrated liquid mixture; - Heating the dissolution liquid and / or the concentrated liquid mixture using a heater (23) placed on the main fluid line (4), where, in particular, the dissolution liquid is heated to at least 60 °C and more specifically to at least 70 °C, and the concentrated mixture is heated to at least 40 °C and more specifically to at least 50 °C; - A concentrate liquid mixture recirculation step, in which the control unit (24) sets a concentrate recirculation path (Z6, X5) and recirculates the concentrated liquid mixture for homogenization.

[0242] In a 210th aspect according to the foregoing aspects, the dry concentrate dissolution program includes a dissolution liquid filling step, which includes a first dissolution liquid filling step, where the first dissolution liquid filling step includes the control unit (24) driving the plurality of valves to set a first dissolution liquid filling path (Z4) and driving a pump (8) to fill a part of the expected total dissolution liquid volume in the main concentrate container (2), the plurality of valves being configured to allow the dissolution liquid to enter the main concentrate container (2), the first dissolution liquid filling path (Z4) including at least a part of the main fluid line (4) on which the pump (8) is configured to operate, the main concentrate container inlet line (31), a first port (6) of the main concentrate container (2), the main concentrate container (2), a second port (7) of the main concentrate container (2), a part of the main concentrate container outlet line (32), an optional degassing chamber (33), and a vent (34). Optionally, a water inlet valve (VWI) placed on the main fluid line (4), a main concentrate container inlet valve (VGI) on the main concentrate container inlet line (31), and a gas valve (VGA) on the vent (34) are opened. In particular, other valves among the plurality of valves configured to operate on the fluid circuit (14) and configurable to allow fluid to enter or leave the first dissolution liquid filling path (Z4) are closed. Optionally, all other valves among the plurality of valves configured to operate on the fluid circuit (14) and different from the water inlet valve (VWI), the main concentrate container inlet valve (VGI), and the gas valve (VGA) are closed.

[0243] In aspect 211 according to any one of the foregoing two aspects, during the concentrate liquid mixture recirculation step, the control unit (24) is configured to control the plurality of valves to set a concentrate recirculation path (Z6) and is configured to control the pump (8) to recirculate the concentrate liquid mixture so as to dissolve the dry concentrate and uniformly mix the concentrate liquid mixture, wherein the control unit (24) is configured to perform a concentration test step to measure the concentration of the concentrate mixture and compare the measured concentration with the expected concentration of the concentrate mixture, and the control unit (24) is configured to measure the concentration during the concentrate mixture recirculation step.

[0244] In aspect 212 according to any one of the foregoing aspects, at least one of the following: - a main concentrate container (2) in fluid communication with the first main container inlets (43, 44); and - an auxiliary concentrate container (3) in fluid communication with the first auxiliary container inlets (45, 46); accommodates a diluted liquid mixture (DM'), wherein the diluted liquid mixture (DM') is a liquid concentrate (LC', LC") previously diluted with a diluting liquid (DLL) (e.g., water), and wherein the control unit (24) is configured to run a liquid concentrate mixing program that includes a first filling step (FS') of a first dilution mixture (DM'), and the control unit (24) is configured to control a valve among the plurality of valves to set an auxiliary concentrate filling path (F1) so as to fill the mixing container (11) with the diluted liquid mixture (DM'), in particular according to a predetermined nominal volume. During the first filling step (FS') of the first dilution liquid mixture (DM'), the control unit (24) is further configured to control the pump (8) to move the diluted liquid mixture (DM') from the corresponding main concentrate container (2) or auxiliary concentrate container (3) to the mixing container (11).

[0245] In aspect 213 according to the foregoing aspect, the filling step (FS') of the first dilution mixture (DM') is followed by at least one water filling step (FSW), wherein the control unit (24) is configured to control a valve among the plurality of valves to set a water filling path (W1) to fill the mixing container (11) at least partially with a predetermined volume of water. During the water filling step, the control unit (24) is further configured to control the pump (8) to cause water from the inlet point (5) of the fluid circuit (14) to flow into the mixing container (11). Among them, the water filling path (FSW) includes at least a part of the main fluid pipeline (4) in which the pump (8) is configured to operate (between the inlet point (5) of the fluid circuit (14) and the sixth junction point (j6)), the mixing container inlet pipeline (15), the inlet (12) of the mixing container (11), and the mixing container (11) is generated. In particular, during the water filling step, the control unit (24) is configured to operate the heater (23) on the main fluid pipeline (4) to heat the water flowing through the water filling path to a temperature suitable for (subsequent) conductivity sensing, for example, 37 °C.

[0246] In the 214th aspect according to the foregoing aspect, the control unit (24) is configured to run the first recirculation step (RS') of the first dilution liquid mixture (DM'). During the first recirculation step (RS'), the control unit (24) is configured to control the valves in the plurality of valves to set the mixing recirculation path (R1) so as to mix the first dilution liquid mixture (DM') and the water filled into the mixing container (11). During the first recirculation filling step (RS') of the first dilution liquid mixture (DM') with added water, the control unit (24) is further configured to control the pump (8) to make the first dilution liquid mixture (DM') and the water flow through the mixing recirculation path (R1). Among them, the control unit (24) is configured to perform the main fluid pipeline concentration test step (MF-CTS') to detect the conductivity change of the first dilution liquid mixture (DM') with added water flowing through the mixing recirculation path (R1) by using at least one conductivity meter (25, 26). The control unit (24) is configured to compare the detected conductivity change in the first dilution liquid mixture (DM') with added water flowing through the mixing recirculation path (R1) with a predetermined threshold, and is configured to interrupt the first recirculation step (RS') of the first dilution liquid mixture (DM') when the conductivity change is lower than the predetermined threshold.

[0247] In aspect 215 according to either of the foregoing two aspects, the other of the main concentrate container (2) and the auxiliary concentrate container (3) houses the main liquid concentrate (LC”), wherein the liquid concentrate mixing procedure includes a second filling step (FS”) of the main liquid concentrate (LC”) to form a dialysis mixture (DiaM), wherein the control unit (24) is configured to perform the second filling step (FS”) of the main liquid concentrate (LC”) after the first filling step (FS’), and the control unit (24) is configured to control the valves among the plurality of valves to set the main concentrate filling path (F2), so as to fill the mixing container (11) with the main liquid concentrate (LC”), in particular according to a predetermined nominal volume. During the filling step of the main liquid concentrate, the control unit (24) is configured to control the pump (8) to move the main liquid concentrate (LC”) to the mixing container (11), in particular, during the second filling step (FS”) of the main liquid concentrate (LC”), the control unit (24) is configured to operate the heater (23) on the main fluid line (4) to heat the main liquid concentrate (LC”) flowing through the main concentrate filling path to a temperature suitable for conductivity sensing, for example, 37 °C.

[0248] In aspect 216 according to the foregoing aspect, after the second filling step of the main liquid concentrate (LC”), there is at least one second recirculation filling step (RS”) of the dialysis mixture (DiaM) formed by adding the main liquid concentrate (LC”) to the first diluted liquid mixture (DM”) of added water. During the recirculation step (RS”) of the second dialysis mixture (DiaM), the control unit (24) is configured to control the valves among the plurality of valves to set the mixing recirculation path (R1) and mix the dialysis mixture (DiaM) into the mixing container (11) to form a dialysis fluid (FD). During the second recirculation step (RS”) of the dialysis mixture (DiaM), the control unit (24) is further configured to control the pump (8) to make the dialysis mixture (DiaM) flow through the mixing recirculation path. In particular, the control unit (24) is configured to perform an additional main fluid line concentration test step (MF-CTS”) to detect the change in conductivity of the dialysis mixture (DiaM) flowing through the mixing recirculation path (R1) by using at least one conductivity meter (25, 26). The control unit (24) is configured to compare the change in conductivity detected in the dialysis mixture (DiaM) with a preselected threshold, and is configured to interrupt the second recirculation step (RS”) of the dialysis mixture (DiaM) when the change in conductivity is lower than the preselected threshold.

[0249] In the summary of the invention and the description: · The mixing container outlet joint (j1) is also referred to as the first joint; · The auxiliary concentrate container inlet joint (j2) is also referred to as the second joint; · The auxiliary concentrate container outlet joint (j3) is also referred to as the third joint; · The main container inlet joint (j4) is also referred to as the fourth joint; · The main container outlet joint (j5) is also referred to as the fifth joint; · The mixing container inlet joint (j6) is also referred to as the sixth joint; Wherein, the main container joints include both the main container inlet joint (j4) and the main container outlet joint (j5); the auxiliary concentrate container joints include the auxiliary concentrate container inlet joint (j2) and the auxiliary concentrate container outlet joint (j3). Regarding the dry concentrate bag

[0250] The dry concentrate bag of any one of the following aspects can be used in any combination in a medical fluid generating device according to any one of the foregoing aspects. The dry concentrate bag of any one of the following aspects can alternatively be used in different medical fluid generating devices, such as in-line / online medical fluid preparation devices or any other device for preparing dialysis fluid starting from at least one dry concentrate bag.

[0251] The 1st independent aspect relates to a dry concentrate bag (100) for preparing dialysis fluid, comprising: · Two plastic films (101, 102), welded together along a welding line (130) to define a receiving space (103) for the dry concentrate; · The dry concentrate (104), received within the receiving space (103); · An inlet portion (110), including an inlet port (111) for receiving fluid, and the inlet port (111) is placed corresponding to the bottom region under the usage conditions of the dry concentrate bag (100); · An outlet portion (120), including an outlet port (121) for allowing the fluid mixed with the dry concentrate (104) to leave the receiving space (103), and the outlet port (121) is placed corresponding to the top region under the usage conditions of the dry concentrate bag (100); Wherein, the inlet portion (110) includes a first inclined welding line (131) and a second inclined welding line (132), both the first inclined welding line (131) and the second inclined welding line (132) expose from the inlet port (111) and define a lower conical portion (112) of the receiving space (103), and the inlet port (111) is placed at the lowest point of the lower conical portion (112), Among them, the outlet portion (120) includes a third inclined welding line (133) and a fourth inclined welding line (134). Both the third inclined welding line (133) and the fourth inclined welding line (134) converge to the outlet port (121) and define an upper conical portion (113) of the accommodation space (103). The outlet port (121) is placed at the highest point of the upper conical portion (113).

[0252] Aspect 2 relates to a dry concentrate bag (100) for preparing a dialysis fluid, comprising: · Two plastic films (101, 102), welded together along a welding line (130) to define an accommodation space (103) for the dry concentrate; · A dry concentrate (104), accommodated in the accommodation space (103); · An inlet portion (110), including an inlet port (111) for receiving a fluid, and the inlet port (111) is placed corresponding to the bottom region under the usage conditions of the dry concentrate bag (100); · An outlet portion (120), including an outlet port (121) for allowing the fluid mixed with the dry concentrate (104) to leave the accommodation space (103), and the outlet port (121) is placed corresponding to the top region under the usage conditions of the dry concentrate bag (100); Among them, the inlet portion (110) includes a first inclined welding line (131) and a second inclined welding line (132). Both the first inclined welding line (131) and the second inclined welding line (132) expose from the inlet port (111) and define a lower conical portion (112) of the accommodation space (103). The inlet port (111) is placed at the lowest point of the lower conical portion (112).

[0253] In Aspect 3 according to the foregoing aspects, the outlet portion (120) includes a third inclined welding line (133) and a fourth inclined welding line (134). Both the third inclined welding line (133) and the fourth inclined welding line (134) converge to the outlet port (121) and define an upper conical portion (113) of the accommodation space (103). The outlet port (121) is placed at the highest point of the upper conical portion (113).

[0254] Aspect 4 relates to a dry concentrate bag (100) for preparing a dialysis fluid, comprising: · A body, including an accommodation space (103) for the dry concentrate; · A dry concentrate (104), accommodated in the accommodation space (103); · An inlet portion (110), including an inlet port (111) for receiving a fluid, and the inlet port (111) is placed corresponding to the bottom region under the usage conditions of the dry concentrate bag (100); · An outlet portion (120) including an outlet port (121) for allowing the fluid mixed with the dry concentrate (104) to leave the accommodation space (103), and the outlet port (121) is placed corresponding to the top region (122) under the usage conditions of the dry concentrate bag (100); Wherein, the accommodation space (103) defines a lower conical portion (112) at the inlet portion (110), and the inlet port (111) is placed at the lowest point of the lower conical portion (112).

[0255] In the fifth aspect according to the foregoing aspect, the accommodation space (103) at the outlet portion (120) defines an upper conical portion (113), and the outlet port (121) is placed at the highest point of the upper conical portion (113).

[0256] The sixth aspect relates to a dry concentrate bag (100) for preparing a dialysis fluid, comprising: · A plastic film defining two layers (101, 102) welded together along a welding line (130), to define an accommodation space (103) for the dry concentrate; · A dry concentrate (104) accommodated in the accommodation space (103); · An inlet portion (110) including an inlet port (111) for receiving fluid, and the inlet port (111) is placed corresponding to the bottom region under the usage conditions of the dry concentrate bag (100); · An outlet portion (120) including an outlet port (121) for allowing the fluid mixed with the dry concentrate (104) to leave the accommodation space (103), and the outlet port (121) is placed corresponding to the top region (122) under the usage conditions of the dry concentrate bag (100); Wherein, the inlet portion (110) includes a first inclined welding line (131) and a second inclined welding line (132), both the first inclined welding line (131) and the second inclined welding line (132) expose from the inlet port (111) and define the lower conical portion (112) of the accommodation space (103), and the inlet port (111) is placed at the lowest point of the lower conical portion (112).

[0257] In the seventh aspect according to the foregoing aspect, the outlet portion (120) includes a third inclined welding line (133) and a fourth inclined welding line (134), both the third inclined welding line (133) and the fourth inclined welding line (134) converge to the outlet port (121) and define the upper conical portion (113) of the accommodation space (103), and the outlet port (121) is placed at the highest point of the upper conical portion (113).

[0258] The eighth aspect relates to a manufacturing method for manufacturing a dry concentrate bag (100), including at least the following steps: · Providing one or two plastic films, the one or two plastic films defining plastic layers facing each other; · Defining a first inclined welding line (131) and a second inclined welding line (132), both the first inclined welding line (131) and the second inclined welding line (132) exposing from an inlet port (111) of the dry concentrate bag (100), the first inclined welding line (131) and the second inclined welding line (132) defining a lower conical portion (112) of a receiving space (103) of the dry concentrate bag (100), · Defining a third inclined welding line (133) and a fourth inclined welding line (134), both the third inclined welding line (133) and the fourth inclined welding line (134) exposing from an outlet port (121) of the dry concentrate bag (100), the third inclined welding line (133) and the fourth inclined welding line (134) defining an upper conical portion (113) of the receiving space (103) of the dry concentrate bag (100), wherein the first inclined welding line, the second inclined welding line, the third inclined welding line, and the fourth inclined welding line (131, 132, 133, 134) are formed by a thermal welding process, wherein the two plastic layers are heated to cause mutual welding, In particular, the dry concentrate bag is according to any one of the foregoing aspects.

[0259] In a ninth aspect according to the foregoing aspects, the step of defining the first inclined welding line, the second inclined welding line, the third inclined welding line, and the fourth inclined welding line (131, 132, 133, 134) includes the step of pressing one of the two plastic films (101, 102) or layers onto the other by a heat seal.

[0260] In a tenth aspect according to any one of the foregoing aspects, the two plastic film layers include: - A first film (101) and a second film (102) that are different from and separated from each other, which define the two plastic film layers (101, 102); or - A single plastic film that is folded back on itself to define the two plastic film layers (101, 102).

[0261] In an eleventh aspect according to any one of the foregoing aspects, the dry concentrate bag (100) further includes a central portion (140) connecting an inlet portion (110) and an outlet portion (120).

[0262] In a twelfth aspect according to the foregoing aspect, the central portion (140) includes a fifth welding line (135) and a sixth welding line (136) that are opposite to each other with respect to the receiving space (103).

[0263] In aspect 13 according to the foregoing aspects, a fifth welding line (135) is connected to a first inclined welding line (131) of the lower tapered portion (112) and is connected to a third inclined welding line (133) of the upper tapered portion (113).

[0264] In aspect 14 according to any one of the foregoing two aspects, a sixth welding line (136) is connected to a second inclined welding line (132) of the lower tapered portion (112) and is connected to a fourth inclined welding line (134) of the upper tapered portion (113).

[0265] In aspect 15 according to any one of the foregoing aspects, the first welding line, the second welding line, the third welding line, the fourth welding line, the fifth welding line, and the sixth welding line define and delimit a receiving space (103).

[0266] In aspect 16 according to any one of the foregoing aspects 12, the fifth welding line (135) and the sixth welding line (136) are substantially parallel to each other to define a rectangular portion of the receiving space (103).

[0267] In aspect 17 according to any one of the foregoing aspects 11, the central portion is substantially rectangular or square in shape.

[0268] In aspect 18 according to any one of the foregoing aspects, the dry concentrate bag (100) is substantially symmetric with respect to a longitudinal axis (A) passing through the inlet port (111) and the outlet port (121).

[0269] In aspect 19 according to any one of the foregoing aspects, the dry concentrate bag extends in length along the longitudinal axis (A) and extends in width along a transverse axis (B) orthogonal to the longitudinal axis (A).

[0270] In aspect 20 according to any one of the foregoing aspects, the first inclined welding line (131) defines an angle (α) with respect to the longitudinal axis (A) passing through the inlet port (111) and the outlet port (121), and the angle (α) is less than a corresponding angle (β) defined by the third inclined welding line (133) of the upper tapered portion (113) with respect to the longitudinal axis (A).

[0271] In aspect 21 according to any one of the foregoing aspects, the second inclined welding line (132) defines an angle (α') with respect to the longitudinal axis (A) passing through the inlet port (111) and the outlet port (121), and the angle (α') is less than a corresponding angle (β') defined by the fourth inclined welding line (134) of the upper tapered portion (113) with respect to the longitudinal axis (A).

[0272] In aspect 22 according to any of the foregoing aspects, the first inclined weld line (131) defines an angle (α) relative to the longitudinal axis (A) passing through the inlet port (111) and the outlet port (121), and the angle (α) is less than the corresponding angle (β’) defined by the fourth inclined weld line of the upper conical portion (113) relative to the longitudinal axis (A).

[0273] In aspect 23 according to any of the foregoing aspects, the second inclined weld line (132) defines an angle (α’) relative to the longitudinal axis (A) passing through the inlet port (111) and the outlet port (121), and the angle (α’) is less than the corresponding angle (β) defined by the third inclined weld line (133) of the upper conical portion (113).

[0274] In aspect 24 according to any of the foregoing aspects, the first inclined weld line (131) and / or the second inclined weld line (132) define an angle (α, α’) relative to the longitudinal axis (A) passing through the inlet port (111) and the outlet port (121), and the angle is less than 60°, particularly less than 45°, and even more specifically less than 30°.

[0275] In aspect 25 according to any of the foregoing aspects, the third inclined weld line (133) and / or the fourth inclined weld line (134) define an angle relative to the longitudinal axis (A) passing through the inlet port (111) and the outlet port (121), and the angle is greater than 30°, particularly greater than 45°, and even more specifically greater than 60°.

[0276] In aspect 26 according to any of the foregoing aspects, the lower conical portion (112) does not include a dead volume near the inlet port (111).

[0277] In aspect 27 according to any of the foregoing aspects, the upper conical portion (113) does not include a dead volume near the outlet port (121).

[0278] In aspect 28 according to any of the foregoing aspects, the accommodation space (103) does not include a dead volume.

[0279] In aspect 28 according to any of the foregoing aspects, the dry concentrate bag (100) is configured to be hung on (for example) a hook.

[0280] In aspect 29 according to any of the foregoing aspects, the dry concentrate bag (100) includes one or more hanging elements (125) placed on the upper conical portion (113), such as holes for a hook or a hanger, and in particular, the one or more hanging elements (125) are configured to hang the dry concentrate bag (100).

[0281] In aspect 30 according to any of the foregoing aspects, the plastic film is configured to withstand a temperature of at least 70 °C, in particular a temperature of 80 to 90 °C.

[0282] In aspect 31 according to any of the foregoing aspects, the receiving space (103) is defined only by these two plastic films, which are flat films.

[0283] In aspect 32 according to any of the foregoing aspects, the receiving space (103) is configured to receive at least 1000 ml of fluid received from the inlet port, optionally at least 1250 ml of fluid.

[0284] In aspect 33 according to any of the foregoing aspects, the dry concentrate bag (100) further includes a first filter (150) placed to filter (all) the fluid leaving the outlet port (121), and the first filter (150) is particularly configured to block the dry concentrate (104) in solid form. Optionally, the filter is placed on an outlet pipe connected to the outlet port.

[0285] In aspect 34 according to any of the foregoing aspects, the dry concentrate bag (100) further includes a second filter (alternatively, a bottom powder or particle stopper) (151) placed corresponding to the inlet port (111) to prevent powder from passing through the inlet port (111).

[0286] In aspect 35 according to any of the foregoing aspects, the dry concentrate (104) received in the receiving space (103) is in the form of powder or particles.

[0287] In aspect 36 according to any of the foregoing aspects, the dry concentrate (104) includes a penetrant, in particular hydrated glucose.

[0288] In aspect 37 according to any of the foregoing aspects, the dry concentrate includes at least 80% hydrated glucose, and in particular 100% hydrated glucose.

[0289] In aspect 38 according to any of the foregoing aspects, the amount of the receiving space (103) and the dry concentrate (104) received in the receiving space in dry form allows dilution with water during use to achieve a concentration in the liquid concentrate between 15% and 70% w / v.

[0290] In aspect 39 according to any of the foregoing aspects, the first inclined welding line (131) and the second inclined welding line (132) are fluid-tight.

[0291] In aspect 40 according to any of the foregoing aspects, the second inclined welding line (132) and the third inclined welding line (133) are fluid-tight.

[0292] In aspect 41 according to any of the foregoing aspects, the fifth welding line (135) and the sixth welding line (136) are fluid-tight.

[0293] In aspect 42 according to any of the foregoing aspects, the welding line (130) is fluid-tight.

[0294] In aspect 43 according to any of the foregoing aspects, the accommodation space (103) communicates with the external environment only through the inlet port (111) and the outlet port (121).

[0295] In aspect 44 according to any of the foregoing aspects, the accommodation space (103) at the lower conical part (112) is "V"-shaped, especially under the condition that the accommodation space (103) is substantially empty.

[0296] In aspect 45 according to any of the foregoing aspects, the accommodation space (103) at the upper conical part (113) is "V"-shaped, especially under the condition that the accommodation space (103) is substantially empty.

[0297] In aspect 46 according to any of the foregoing aspects, the accommodation space (103) at the lower conical part (112) is "cone"-shaped, especially under the condition that the accommodation space (103) is filled with dry concentrate.

[0298] In aspect 47 according to any of the foregoing aspects, the accommodation space (103) at the upper conical part (113) is "cone"-shaped, especially under the condition that the accommodation space (103) is filled with dry concentrate (104) and optionally filled with a medical fluid.

[0299] In aspect 48 according to any of the foregoing aspects, the upper conical part (113) is three-dimensional.

[0300] In aspect 49 according to any of the foregoing aspects, the lower conical part (112) is three-dimensional.

[0301] In aspect 50 according to any of the foregoing aspects, the dry concentrate bag is made of a flexible plastic film.

[0302] In aspect 51 according to any of the foregoing aspects, the accommodation space (103) is configured to increase its volume between the condition where the accommodation space (103) is empty and the condition where the accommodation space (103) contains dry concentrate (104) and / or fluid.

[0303] In aspect 52 according to any of the foregoing aspects, the first inclined welding line (131) is straight.

[0304] In aspect 53 according to any of the foregoing aspects, the second inclined welding line (132) is straight.

[0305] In aspect 54 according to any of the foregoing aspects, the third inclined welding line (133) is straight.

[0306] In aspect 55 according to any of the foregoing aspects, the fourth inclined welding line (134) is straight.

[0307] In aspect 56 according to any of the foregoing aspects, the fifth welding line (135) is straight.

[0308] In aspect 57 according to any of the foregoing aspects, the sixth welding line (136) is straight.

[0309] In aspect 58 according to any of the foregoing aspects, the minimum dimension of the accommodation space (103) is located at the lower conical portion (112) and the upper conical portion (113).

[0310] In aspect 59 according to any of the foregoing aspects, the dry concentrate bag (100) further includes a central portion (140) connecting the inlet portion (110) and the outlet portion (120). The central portion (140) includes a fifth welding line (135) and a folding line (137) that are opposite to each other with respect to the accommodation space (103). The fifth welding line (135) is connected to the first inclined welding line (131) of the lower conical portion (112) and is connected to the third inclined welding line (133) of the upper conical portion (113). The folding line (137) is connected to the second inclined welding line (132) of the lower conical portion (112) and is connected to the fourth inclined welding line (134) of the upper conical portion (113). In particular, the first welding line, the second welding line, the third welding line, the fourth welding line, the fifth welding line and the folding line (137) define and delimit the accommodation space (103).

[0311] In aspect 60 according to any of the foregoing aspects, the fifth welding line (135) and the folding line (137) are substantially parallel to each other to define a rectangular portion of the accommodation space (103).

[0312] In aspect 61 according to any of the foregoing aspects, the dry concentrate (104) includes a buffer and an electrolyte. In particular, the dry concentrate is directed to peritoneal dialysis or is directed to hemodialysis.

[0313] In aspect 62 according to any of the foregoing aspects, the dry concentrate (104) comprises at least one substance from the group among NaCl, NaLa, CaCl2, MgCl2, in particular wherein at least 90%, in particular at least 95% of the dry concentrate consists of NaCl and a buffer such as sodium lactate (NaLa).

[0314] In aspect 62 according to any of the foregoing two aspects, the amount of the accommodation space (103) and the dry concentrate (104) accommodated in the accommodation space in dry form is such that upon use it allows dilution with water to achieve a concentration in the liquid concentrate between 10% and 30% w / v.

[0315] In aspect 63 according to any of the foregoing aspects, the dry concentrate (104) comprises NaCl and NaLa.

[0316] In aspect 64 according to any of the foregoing aspects, the dry concentrate (104) comprises NaCl at a concentration higher than 45%, in particular higher than 50%, in particular between 50% and 55%.

[0317] In aspect 65 according to any of the foregoing aspects, the dry concentrate (104) comprises NaLa at a concentration higher than 35%, in particular higher than 40%, in particular between 40% and 50%.

[0318] In aspect 66 according to any of the foregoing aspects, in the case where all powders are anhydrous, the dry concentrate (104) comprises the following substance concentrations: Components Weight Percent NaCl 53.65％ CaCl2 1.38％ MgCl2 0.24％ NaLa 44.73％

[0319] Furthermore, any one or more of the features, functionalities, and alternatives described in any one of the foregoing aspects or parts and / or combinations thereof Figures 1A to 1Q can be combined with any one of the features, functionalities, and alternatives described in any one of the other figures in combination Figures 2 to 4 therewith.

[0320] Thus, an advantage of the present disclosure is to provide a system for manufacturing fresh dialysis fluid that can be accommodated or stored in a mixing container and used later.

[0321] Another advantage of the present disclosure is to provide a system that manufactures fresh dialysis fluid for a patient, for example for home dialysis, which only requires the use of liquids and / or dry concentrates, thereby reducing the handling of medical fluid bags.

[0322] Another advantage of the present disclosure is to provide a system for manufacturing fresh dialysis fluid using a simple hydraulic circuit that requires only a single pump, which operates on the main fluid pipeline and is capable of managing various medical fluid production steps.

[0323] Yet another advantage of the present disclosure is to provide a system for manufacturing fresh dialysis fluid that can be placed in a container for later use.

[0324] In addition, it is advantageous to bring fluids such as PD fluid, CRRT fluid, lactated Ringer's solution, etc. closer in time and distance to the point of use by the patient, which reduces the amount of supply that must be stored, for example, in the patient's home.

[0325] Another advantage is the use of one or more concentrates to prepare PD fluid.

[0326] Another advantage of the present disclosure is to provide a durable fluid circuit, which is thus reusable and reduces the patient's effort in preparing medical fluids. For example, there is no need to establish disposable pipelines and / or load fluid flow paths into medical devices. Additionally, less material waste is generated.

[0327] Additional features and advantages are described in the following detailed description section and the drawings, and will be apparent from the following detailed description section and the drawings. The features and advantages described herein are not all-inclusive. In particular, given the drawings and description, many additional features and advantages will be apparent to those of ordinary skill in the art. Moreover, any particular embodiment need not have all the advantages listed herein, and separately advantageous embodiments are explicitly contemplated. Additionally, it should be noted that the language used in the specification is mainly selected for readability and guidance purposes, and thus does not limit the scope of the subject matter of the invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0328] Figure 1 is a schematic diagram of a fluid circuit of a medical fluid generation device according to a first embodiment of the present invention;

[0329] Figure 1A is Figure 1 a schematic diagram of the fluid circuit shown, in which the exhaust flow path is appropriately highlighted;

[0330] Figure 1B is Figure 1 a schematic diagram of the fluid circuit shown, in which the main fluid pipeline perfusion path is appropriately highlighted;

[0331] Figure 1C is Figure 1 a schematic diagram of the fluid circuit shown, in which the recirculation perfusion path is appropriately highlighted;

[0332] Figure 1D is Figure 1 a schematic diagram of the fluid circuit shown, in which the first dissolved liquid filling path is appropriately highlighted;

[0333] Figure 1E is Figure 1 a schematic diagram of the fluid circuit shown, in which the second dissolved liquid filling path is appropriately highlighted;

[0334] Figure 1F is Figure 1 a schematic diagram of the fluid circuit shown, in which the first concentrate recirculation path is appropriately highlighted;

[0335] Figure 1G is Figure 1 a schematic diagram of the fluid circuit shown, in which the auxiliary exhaust is appropriately highlighted;

[0336] Figure 1H is Figure 1 a schematic diagram of the fluid circuit shown, in which the first auxiliary recirculation perfusion path is appropriately highlighted;

[0337] Fig. 1I is Figure 1 a schematic diagram of the fluid circuit shown, in which the first auxiliary dissolved liquid filling path is appropriately highlighted;

[0338] Figure 1J is Figure 1 a schematic diagram of the fluid circuit shown, in which the second auxiliary dissolved liquid filling path is appropriately highlighted;

[0339] Figure 1K is Figure 1 a schematic diagram of the liquid circuit shown, in which the second concentrate recirculation path is appropriately highlighted;

[0340] Figure 1L is Figure 1 a schematic diagram of the liquid circuit shown, in which the mixing vessel discharge path is appropriately highlighted;

[0341] Figure 1M is Figure 1 a schematic diagram of the liquid circuit shown in, in which the mixing vessel filling path is appropriately highlighted;

[0342] Figure 1N is Figure 1 a schematic diagram of the liquid circuit shown, in which the auxiliary concentrate filling path is appropriately highlighted;

[0343] Fig.1O is Figure 1 a schematic diagram of the liquid circuit shown, in which the water filling path is appropriately highlighted;

[0344] Figure 1P is Figure 1 a schematic diagram of the liquid circuit shown, in which the mixing recirculation path is appropriately highlighted;

[0345] Figure 1Q is Figure 1 a schematic diagram of the liquid circuit shown, in which the main concentrate filling path is appropriately highlighted.

[0346] Figure 2 a schematic diagram of the fluid circuit of a medical fluid generation device according to a second embodiment of the present invention;

[0347] Figure 3 a schematic diagram of the fluid circuit of a medical fluid generation device according to a third embodiment of the present invention;

[0348] Figure 4 a schematic diagram of the fluid circuit of a medical fluid generation device according to a fourth embodiment of the present invention;

[0349] Figure 4A a schematic diagram of the fluid circuit of a medical fluid generation device according to a fifth embodiment of the present invention;

[0350] Figure 4B a schematic diagram of the fluid circuit of a medical fluid generation device according to a sixth embodiment of the present invention;

[0351] Figure 4C a schematic diagram of the fluid circuit of a medical fluid generation device according to a seventh embodiment of the present invention

[0352] Figure 5 is a general block diagram of a dry concentrate dissolution procedure, which can be executed by using a medical fluid generation device as shown in Figure 1 、 2 、3 and 4;

[0353] Figure 6 is about Figure 5 a detailed block diagram of the dry concentrate dissolution procedure, which can be executed by using a medical fluid generation device as shown in Figure 1 、 2 、3 and 4;

[0354] Figure 7 is a general block diagram of a liquid concentrate mixing procedure, which can be executed by using a medical fluid generation device as shown in Figure 1 、 2 、3 and 4;

[0355] Figure 8 is about Figure 7Second general block diagram of the liquid concentrate mixing procedure, which can be implemented using a medical fluid generation device as shown in Figure 1 , 2 , 3, and 4;

[0356] Fig. 9 Regarding Figure 6 and Figure 7 detailed block diagram of the liquid concentrate mixing procedure, which can be implemented using a medical fluid generation device as shown in Figure 1 , 2 , 3, and 4;

[0357] Fig.10 , 11 and 14 illustrate dry bag concentrates according to embodiments of the present specification;

[0358] Fig. 10A illustrates an alternative embodiment of the dry bag concentrate bag;

[0359] Fig.12 and Fig.13 respectively illustrate Fig.10 and Fig.11 transversely and longitudinally sectioned dry bags;

[0360] Fig.15 illustrates a dry bag concentrate according to another embodiment of the present specification;

[0361] Fig.16 and Fig.17 respectively illustrate Fig.15 transversely and longitudinally sectioned dry bags;

[0362] Figures 18A to 18C illustrates the dissolution sequence of the dry concentrate;

[0363] Fig.19 illustrates a dry bag concentrate according to another embodiment of the present specification;

[0364] Fig. 20 and Fig.21 respectively illustrate Fig.19 transversely and longitudinally sectioned dry bags. Detailed Description Medical Fluid Generation Device

[0365] Considering Figures 1 to 4C the embodiment shown, a medical fluid generation device 1 for preparing a medical fluid (such as a dialysis fluid, particularly a PD fluid or an HD fluid) is schematically illustrated.

[0366] As Figures 1 to 4As shown, the medical fluid device 1 includes a support structure 42 that defines a housing for receiving different internal parts and / or internal elements and / or internal components of the medical fluid device 1. In addition, the support structure 42 provides different external connection areas that allow one or more external elements and / or external components of the medical fluid device 1 to be operatively connected to and interact with the aforementioned internal parts and / or internal elements and / or internal components of the medical fluid device 1 in order to perform the different processes and functions described throughout this specification.

[0367] Always refer to Figures 1 to 4 In the illustrated embodiment, the support structure 42 houses a fluid circuit 14 that includes a main fluid line 4 provided with an inlet point 5 for receiving water. The support structure surrounds the fluid circuit 14, valves, pumps, and other internal components connected to the fluid circuit (as described in further detail below), thereby protecting them from direct access by the user. Additionally, the fluid circuit 14 is durable (i.e., non-disposable) and is used each time medical fluid needs to be generated, provided it has been appropriately sterilized. Of course, in different and alternative embodiments, the fluid circuit can be a disposable circuit.

[0368] The support structure 42 has an inlet 5a for connection to a water source. Depending on the specific embodiment of the medical fluid generating device 1, either pure water is supplied to the device through the inlet 5a or water that needs to be purified is provided. In fact, the medical fluid generating device 1 may or may not be provided with a purification device 50.

[0369] Regardless of the configuration, the inlet point 5 of the main fluid line 4 receives pure water, for example, water that has been treated to remove impurities, contaminants, chemicals, and harmful microorganisms as well as solutes. The pure water can be obtained by distillation, deionization, reverse osmosis, or other suitable processes and meets the definition of pure water in the relevant pharmacopoeia. For example, pure water can be generated using a known reverse osmosis device. In one example (see Figure 4A ), the purification device 50 (e.g., the reverse osmosis device) can be included inside the support structure 42, upstream of the inlet point 5. Water (such as tap water) enters the support structure through the water inlet 5a and reaches the purification device 50. The water is purified and sent towards the inlet point 5.

[0370] In an alternative embodiment (e.g., see Figure 1), pure water directly reaches the inlet 5a, in particular from an external supply source (not shown in the figures), which can be selected among different known supply sources. Preferably, the external supply source can include a water purification device 50, which is configured to supply pure water to the inlet 5a and thus to the inlet point 5 for receiving pure water. The water purification device includes a central water purification station configured to supply water to the inlet 5a and the inlet point 5 or an independent water purifier configured to supply water to the inlet 5a and the inlet point 5. To allow the external supply source to supply pure water to the inlet point 5, the support structure 42 is externally provided with a suitable inlet connection. In Figure 1 embodiments, the inlet 5a and the inlet point 5 can coincide. It is worth noting that, as an alternative design, Figure 1 , 2 , 3, 4B and 4C embodiments can also include a purification device 50 located downstream of the inlet 5a.

[0371] In all embodiments, the support structure 42 also houses a pump 8, which is preferably a positive displacement pump 8, which is configured to operate on the main fluid line 4 to circulate at least one fluid at least in the main fluid line 4 of the fluid circuit 14. As will be apparent from the following description, a single pump 8 may be sufficient for operating the device. More specifically, such a pump 8 always moves the fluid in the same direction (i.e., never operates in reverse pumping).

[0372] The support structure 42 houses a plurality of valves, which are configured to operate on the fluid circuit 14 in order to set different fluid paths for the fluid inside the fluid circuit 14, in particular according to the different processes and operations to be performed by the medical fluid generation device 1. Generally, a valve has an open state allowing fluid to pass through and a closed state preventing any fluid from passing through. Any type of valve suitable for this task can be used, such as on / off valves, pinch valves, cartridge valves, proportional valves, etc...

[0373] The medical fluid generation device 1 also includes a control unit 24, which is configured to at least operate the pump 8 and / or the plurality of valves in order to control and manage the configuration of the plurality of valves and establish the fluid paths followed by one or more fluids inside the fluid circuit 14. Advantageously, the control unit 24 is electrically and / or electronically connected to the plurality of valves and other parts and / or elements and / or components of the medical generation device 1 through a plurality of known electrical and / or electronic connections not shown in the figures. Alternatively, the control unit 24 can be connected to the plurality of valves and other parts and / or elements and / or components of the medical generation device 1 through a wireless connection system, which requires at least one operatively inserted unit capable of transmitting and receiving one or more signals by using different communication protocols known in the art.

[0374] As Figures 1 to 4 As shown in FIGS. 4B and 4C, the support structure 42 is provided with four container connectors / inlets 43, 44, 45, 46 that are in fluid communication with the internal fluid circuit 14, so as to allow one or more fluids flowing along the fluid circuit 14 to be conveyed to at least one external portion of the fluid circuit 14; the container connectors / inlets 43, 44, 45, 46 can also be used to convey fluids from connected components to the internal fluid circuit.

[0375] In particular, the support structure 42 has a first main container inlet 43 and a second main container inlet 44 that are designed to be connected to the main concentrate container 2. Both the first main container inlet 43 and the second main container inlet 44 are in fluid communication with the main fluid line 4 of the fluid circuit 14. If the main concentrate container 2 (for example) has only one inlet / outlet due to its containing a liquid concentrate, then only one of these two inlets 43, 44 is used (see Figure 4 and Figure 4A ). Conversely, if the main concentrate container 2 has one inlet and one outlet, both the first main container inlet 43 and the second main container inlet 44 are used (for example, see Figure 1-3 and FIGS. 4B / 4C).

[0376] The support structure 42 also has a first auxiliary container inlet 45 and a second auxiliary container inlet 46 that are designed to be connected to the auxiliary concentrate container 3. Both the first auxiliary container inlet 45 and the second auxiliary container inlet 46 are in fluid communication with the main fluid line 4 of the fluid circuit 14. If the auxiliary concentrate container 3 (for example) has only one inlet / outlet due to its containing a liquid concentrate, then only one of these two inlets 45, 46 is used (see Figure 3-4 and Figure 4A ). Conversely, if the auxiliary concentrate container 3 has one inlet and one outlet, both the first auxiliary container inlet 45 and the second auxiliary container inlet 46 are used (for example, see Figure 1-2 and Figure 4B / 4C).

[0377] As described above, the medical fluid generating device 1 is provided with at least one concentrate container, preferably two concentrate containers 2, 3, which respectively have at least one port 6, 7, 9, 10 that can be in fluid communication with or placed in fluid communication with the main fluid line 4 of the fluid circuit 14 via the corresponding container inlets 43, 44, 45, 46.

[0378] Preferably, the medical fluid generating device 1 includes a main concentrate container 2 having at least one port 6, 7 and an auxiliary concentrate container 3 having at least one port 9, 10, the ports 6, 7 being able to be in fluid communication with or placed in fluid communication with the main fluid line 4 of the fluid circuit 14, and the ports 9, 10 being able to be in fluid communication with or placed in fluid communication with the main fluid line 4 of the fluid circuit 14. Each of the main concentrate container 2 and the auxiliary concentrate container 3 at least partially defines a corresponding external additional part or extension of the fluid circuit 14, which can be connected to the corresponding first main container inlet 43 and the corresponding first auxiliary container inlet 45.

[0379] Considering Figure 1 , 2 and the embodiment shown in FIG. 3, the main concentrate container 2 has a first port 6 in fluid communication with the main fluid line 4 of the fluid circuit 14 through the corresponding first main container inlet 43 and a second port 7 in fluid communication with the main fluid line 4 of the fluid circuit 14 through the corresponding second main container inlet 44. Additionally, a filter 49 is present in the line connecting the second port 7 to the second main container inlet 44 to prevent foreign elements (e.g., particles) from reaching the internal components of the device.

[0380] Referring to Figure 4 and Figure 4A the embodiment shown, the main concentrate container 2 has only one port 6, the first port 6 preferably being in fluid communication with the main fluid line 4 of the fluid circuit 14 through the first main container inlet 43. Generally, when the main concentrate container 2 has only the first port 6 to be connected to the first main container inlet 43, it contains the main liquid concentrate LC” or another liquid concentrate that is also ready to be mixed or obtained through a corresponding dissolution procedure and is to be mixed with at least another liquid (such as water). Considering Figure 1 and Figure 2 the embodiment shown, the auxiliary concentrate container 3 has a first port 9 in fluid communication with the main fluid line 4 through the first auxiliary container inlet 45 of the fluid circuit 14 and a second port 10 in fluid communication with the main fluid line 4 of the fluid circuit 14 through the second auxiliary container inlet 46. Additionally, a filter 49 is present in the line connecting the second port 10 to the second auxiliary container inlet 46 to prevent foreign elements (e.g., particles) from reaching the internal components of the device.

[0381] Referring to Figure 3 and Figure 4In the illustrated embodiment, the auxiliary concentrate container 3 has only one port 9, and the first port 9 is preferably in fluid communication with the main fluid line 4 of the fluid circuit 14 through the first auxiliary container inlet 45. Generally, when the auxiliary concentrate container 3 has only the first port 9 connected to the first auxiliary container inlet 45, it contains an auxiliary liquid concentrate LC' ready to be mixed with at least another liquid or a liquid concentrate also ready to be mixed or obtained through a corresponding dissolution process.

[0382] Of course, in cases where at most one, two or three inlets are required, the support structure 42 may have only three inlets 43, 44 and 45; for example, a main concentrate 2 may include two ports 6, 7 which must be connected to the support structure 42, whereby two corresponding inlets (e.g., 43, 44) are required, while an auxiliary container 3 may have only one port 9 to connect to, for example, the inlet 45. In this case, there may be no Figure 3 inlet 46. Thus, in the case where both the main concentrate container and the auxiliary concentrate container 2, 3 have a respective port 6, 9 to connect to their respective inlets 43, 45 (see Figure 4A , and in this embodiment inlets 44 and 46 are not provided / are not required), the support structure 42 may have only two inlets 45, 46.

[0383] Regardless of the specific embodiment involved, the ports 6, 7, 9, 10 of the respective concentrate containers 2, 3 may be in fluid communication with or placed in fluid communication with the main fluid line 4 of the fluid circuit 14 through the corresponding container inlets 43, 44, 45, 46 provided on the support structure 42. Thus, the container inlets 43, 44, 45, 46 of the support structure 42 allow the medical generation device 1 to provide different configurations of the concentrate containers 2, 3 to be used, which may contain dry concentrates DC to be dissolved and / or diluted and / or liquid concentrates LC', LC" to be diluted. In particular, it must be noted that in Figure 1 , 2 , 4B and 4C of the illustrated embodiment, the auxiliary concentrate container 3 contains dry concentrates DC to be dissolved and / or diluted, while in Figure 3 , 4 and 4A of the illustrated embodiment, the auxiliary concentrate container 3 contains an auxiliary liquid concentrate LC' to be diluted and mixed with another liquid concentrate.

[0384] Referring to Figure 1 , 2 , 3, 4A, 4B and 4C, the medical fluid generation device 1 has a mixing container 11, which has an inlet 12 and an outlet 13 in fluid communication with the main fluid line 4 of the fluid circuit 14. According to Figure 1In the illustrated embodiment, the mixing container 11 is operably received inside the support structure 42 and is not easily accessible from the outside unless the support structure 42 is appropriately opened. When the mixing container 11 is operably placed inside the support structure 42, as Figure 1 illustrated, the medical fluid generating device 1 is provided with a sensor 17 for generating and giving information related to the volume of one or more fluids contained in the mixing container 11 itself.

[0385] The sensor 17 includes at least one weighing scale 17a and / or at least one level sensor 17b to generate an output signal related to the data of the significant volume value inside the mixing container 11. Sensors different from the sensors just mentioned can alternatively be used to detect the fluid volume / level inside the mixing container 11. For example, the mixing container 11 can be filled with the vent 22 closed, and the headspace is determined by the increase in pressure inside the container (at least the initial pressure, the final pressure, and the pumping volume should be known). Preferably, the mixing container 11 includes a substantially closed container (except for the liquid inlet and outlet and the vent).

[0386] When the mixing container 11 is operably placed inside the support structure 42 as Figure 1 illustrated, preferably, the medical fluid generating device 1 is provided with at least one sterilization device 18 configured to operate on the fluid volume contained inside the mixing container 11. In particular, the sterilization device 18 includes a UV sterilization device that is placed inside the mixing container 11, for example, on the bottom wall 11a of the mixing container. Generally, the mixing container 11 operably placed inside the support structure 42 is a non-removable and / or non-disposable container.

[0387] Additional (or alternative) sterilization devices can also be used. For example, one or more sterilization devices (e.g., UV devices) can be placed on other parts of the fluid circuit 14, such as on the main fluid line 4.

[0388] According to Figure 1In the illustrated embodiment, the mixing container includes a vent 19 which includes a vent line 20 for selectively discharging excess air contained inside the mixing container. Preferably, the vent 19 is placed on the top 11b of the mixing container 11, and more preferably, the vent 19 is placed on the uppermost wall of the mixing container 11. Optionally, the vent 19 is provided with a filter 21 and / or an air valve 22 capable of filtering any air passing through the vent line 20 to selectively block the air passage through the vent line 20. The valve 22 of the vent 19 is placed along the vent line 20, particularly between the mixing container 11 and the filter 21. In addition, at the end of the vent line 20, downstream of the filter 21 and the air valve 22, depending on the position relative to the mixing container 11, the vent line 20 and the vent 19 are thus connected to the air discharge section 1a of the medical generating device 1. Note that the air discharge section 1a can lead to the external environment or can be connected to the discharge outlet line 30 of the device, where the fluid to be discharged is transported and discharged (as described in more detail below).

[0389] Referring to Figure 2 、 3 and the embodiment shown in FIG. 4, the mixing container 11 is positioned outside the support structure 42 and is both visible and directly accessible from the outside. Advantageously, when the mixing container 11 is placed outside the support structure 42, the mixing container 11 can include a bag, which is preferably flexible, particularly transparent. Since the mixing container 11 is a transparent flexible bag, the volume of the fluid contained therein can be immediately inspected through the transparent structure of the flexible bag.

[0390] When the mixing container 11 is operably and / or physically placed outside the support structure 42, a sensor 17 can also be used, which is capable of inspecting the volume of the fluid inside the mixing container 11 when the mixing container 11 is placed inside the support structure 42.

[0391] Preferably, when the mixing container 11 is operably and / or physically placed outside the support structure 42, it is a removable and / or disposable container. To be able to be removed from the support structure 42, according to Figure 2 、 3 and the embodiment shown in FIGS. 3 and 4, the support structure 42 has a mixing container inlet port 47 of the fluid circuit 14 and a mixing container outlet port 48 of the fluid circuit 14 to be in fluid communication with the inlet 12 of the mixing container 11 and the outlet 13 of the mixing container 11 respectively.

[0392] In particular, both the mixing vessel inlet port 47 and the mixing vessel outlet port 48 are in fluid communication with the main fluid line 4 of the fluid circuit 14 to place the latter in fluid communication with the inlet 12 and the outlet 13 of the mixing vessel 11. Advantageously, both the inlet 12 and the outlet 13 of the mixing vessel 11 include self-sealing valves to prevent fluid from flowing out of the mixing vessel 11 once it is separated from the medical fluid generating device 1 when the used mixing vessel 11 needs to be replaced with another unused mixing vessel 11.

[0393] A medical fluid generating device 1 according to Figure 1 will be described in more detail. The main fluid line 4 extends (develops) from the inlet point 5 towards the pump 8 and in sequence reaches the first junction point j1, the second junction point j2, the third junction point j3, the fourth junction point j4, the fifth junction point j5, a heater 23 configured to heat the fluid circulating in the medical fluid generating device 1, and at least one sensor 52, particularly two sensors 52, 53 placed in series with each other. One or both of the sensors 52, 53 are configured to measure the properties of the fluid flowing in the main fluid line 4. Generally, the sensors 52, 53 can measure any one of the electrical conductivity of the fluid, the concentration of substances in the fluid, concentration-related physical properties (such as the speed of sound, viscosity, density, the temperature of the fluid), and the optical properties of the fluid flowing in the main fluid line 4 (and combinations thereof). For example, the sensor 52 and / or the sensor 53 can be an electrical conductivity sensor, a concentration sensor, a temperature sensor, an optical sensor, or a sound sensor.

[0394] In a specific embodiment, the sensor 52 is a conductivity meter 25, and the sensor 53 is also a conductivity meter 26; preferably, the two conductivity meters 25, 26 are positioned in series with each other.

[0395] The conductivity meter 25 is configured to determine the electrical conductivity of one or more fluids circulating in the medical fluid generating device 1. The second conductivity meter 26 is configured to independently determine the electrical conductivity of one or more fluids circulating in the medical fluid generating device 1. Both the conductivity meter 25 and the second conductivity meter 26 determine and detect the electrical conductivity of the same fluid flowing along the main fluid line 4 to provide a backup measurement.

[0396] A temperature sensor T1 is also present in the main fluid line 4; generally, but not necessarily, the temperature sensor T1 is incorporated in the conductivity meter 25 and provides a temperature signal to the control unit 24. The temperature signal is used to control the heater 23 and the heating power. Additionally, the temperature signal is also used to check that the conductivity meter 25 operates within its optimal temperature range. Since two conductivity meters 25, 26 are provided, two temperature sensors T1 and T2 are also provided. The sensor T is only at Figure 1 and Figure 4AAs shown. Of course, temperature sensor T1 and / or T2 can be a sensor separate from other components, i.e., an independent component that measures the temperature of the fluid flowing in the main fluid line 4 at different positions typically downstream of the fifth joint j5 and upstream of the sixth joint j6.

[0397] The heater 23 and the conductivity meters 25, 26 (as well as the temperature sensor T1 and / or T2) are controlled by a control unit 24, which is appropriately set to manage the signals and data sent to and received from the heater 23 and the conductivity meters 25, 26.

[0398] Throughout this specification, each of the just-mentioned elements in the first five joints j1, j2, j3, j4, j5, the heater 23, and the conductivity meters 25, 26 will be described in detail.

[0399] As Figure 1 shown, the first joint j1, the second joint j2, the third joint j3, the fourth joint j4, and the fifth joint j5 are positioned one after another in sequence from the inlet point 5 to the pump 8, i.e., the first joint j1 is downstream of the inlet point 5, the second joint j2 is downstream of the first joint, the third joint j3 is downstream of the second joint j2, the fourth joint element j4 is downstream of the third joint j3, and the fifth joint element j5 is downstream of the fourth joint j4.

[0400] The heater 23 is located downstream of the fifth joint j5, and the conductivity meters 25, 26 are located downstream of the heater 23 and upstream of the pump 8.

[0401] Therefore, the first joint j1, the second joint j2, the third joint j3, the fourth joint j4, the fifth joint j5, the heater 23, and the conductivity meters 25, 26 are upstream of the pump 8.

[0402] The conductivity meter 25 is inserted between the heater 23 and the pump 8, and the second conductivity meter 26 is inserted between the heater 23 and the first conductivity meter 25. Of course, the placement of the conductivity meters 25 and 26 on the main fluid line 4 can be reversed. Additionally, the heater 23 is typically placed upstream of the conductivity meters 25, 26 for improved temperature control (e.g., to 37 °C) at the positions of the conductivity meters 25, 26. Different configurations where the heater 23 is placed downstream of one or both of the conductivity meters 25, 26 can function because, as described below, a closed recirculation loop is used to mix and homogenize the fluid.

[0403] Unlike the elements placed upstream of the pump 8 mentioned above, the sixth joining element j6 provided on the main fluid line 4 is positioned downstream of the pump 8. Each of the joining points j1, j2, j3, j4, j5, j6 provides a connection between the main fluid line 4 of the fluid circuit 14 and at least one line, pipe or branch of the fluid circuit 14 that is different from the main fluid line 4.

[0404] According to Figure 3 and Figure 4 the embodiment shown, the positions of the second joining point j2, the third joining point j3, the fourth joining point j4 and the fifth joining point j5, and the positions of the heater 23, the conductivity meters 25, 26 and the sixth joining point j6 are the same as Figure 1 the embodiment shown. However, the position of the first joining point j1 is changed. In particular, according to Figure 3 and Figure 4 the embodiment shown, the first joining point j1 is placed on the main fluid line 4, between the fifth joining point j5 and the heater 23.

[0405] Therefore, according to Figure 3 and Figure 4 the embodiment shown, the second joining point j2 is placed upstream of the third joining point, the third joining point j3 is placed upstream of the fourth joining point, the fourth joining point j4 is placed upstream of the fifth joining point, the fifth joining point j5 is placed upstream of the first joining point, the first joining point j1 is placed upstream of the heater 23, which is placed upstream of the conductivity meters 25, 26, which are placed upstream of the pump 8, and the pump is placed upstream of the sixth joining point j6. This is a less preferred but feasible option.

[0406] The position of the first joining point j1 can be changed on the main fluid line 4 of the fluid circuit 14 relative to the first four joining points j2, j3, j4, j5, but it cannot be changed relative to the heater 23, the conductivity meters 25, 26 and the sixth joining point j6 in the sense that the first joining point j1 must be placed upstream of the sixth joining point j6. The relative positions of the said joining points, heater and meters are related to the normal operation of the equipment during recirculation and mixing. In fact, the temperature of the recirculating fluid needs to be controlled by the heater 23, and its conductivity needs to be measured during recirculation. Therefore, it can be clearly seen from the following description of the process for dissolving the concentrate and / or mixing the fluids that the heater 23 and the conductivity meters 25, 26 must be included in the recirculation path R1. In addition, the position of the first joining point j1 is generally upstream of all the other joining points j2, j3, j4, j5, so that any fluid from the mixing chamber 11 can flush all the pipes of the main fluid line 4 that provide fluid injection. However, this positioning is only recommended and not strictly necessary.

[0407] Returning to Figure 1In the illustrated embodiment, the plurality of valves includes a water inlet valve VWI placed on the main fluid line 4 between the inlet point 5 and the first junction point j1. When the valve VWI is open, fluid arriving from the inlet 5a of the support structure 42 and the inlet point 5 of the main fluid line 4 of the fluid circuit 14 can flow along the main fluid line 4 towards the first five junction points j1, j2, j3, j4, j5, the heater 23, the conductivity meters 25, 26, the pump 8, and the sixth junction point j6. When the valve VWI is closed, the fluid passage is blocked upstream of the first junction point j1.

[0408] According to Figure 2 , 3 and the embodiment shown in FIG. 4, the inlet point 5 can also be directly connected to the main fluid line 4. In this case, the main fluid line 4 is always supplied by the inlet 5a and the inlet point 5.

[0409] Continuing with the detailed description of the fluid circuit 14 common to all embodiments, the fluid circuit 14 includes a mixing vessel inlet line 15 that connects the sixth junction point j6 placed on the main fluid line 4 to the inlet 12 of the mixing vessel 11.

[0410] The plurality of valves includes a mixing vessel inlet valve VMI configured to operate on the mixing vessel inlet line 15. The sixth junction point j6 is operatively inserted between the pump 8 and the vessel inlet valve VMI. The mixing vessel inlet line 15 is directly connected to the inlet 12 of the mixing vessel 11, while referring to Figure 2 , 3 and the embodiment shown in FIG. 4, the mixing vessel inlet line 15 is connected to the inlet 12 of the mixing vessel 11 through a mixing vessel inlet port 47.

[0411] Advantageously, the medical fluid generation device 1 includes a pressure sensor P2 configured to sense the pressure occurring on the main fluid line 4 downstream of the pump 8. The pressure sensor P2 can be placed at any position in the fluid circuit where the pressure borne is the same as the pressure present in the main fluid line 4 downstream of the pump. In the illustrated embodiment, the pressure sensor P2 is placed on the mixing vessel inlet line 15, optionally between the sixth junction point j6 and the mixing vessel inlet valve VMI.

[0412] Referring to Figure 1 , 2, 3, 4A, 4B, and 4C, the fluid circuit 14 further includes a medical fluid outlet 27 for supplying the fluid reaching from the sixth junction j6 to an external medical device (not shown in any figure), such as a dialysis device, such as a peritoneal circulator or a hemodialysis device. In particular, the fluid outlet 27 is connected to the main fluid line 4 via a medical fluid outlet line 28, and the medical fluid outlet line 28 is directly connected to the mixing container inlet line 15 downstream of the sixth junction j6 and the pump 8 and upstream of the mixing container inlet valve VMI. The fluid flowing along the main fluid line 4 flows from the mixing container inlet line 15 towards the mixing container inlet valve VMI and the medical fluid outlet line 28.

[0413] Along the medical fluid outlet line 28, the plurality of valves includes a medical fluid outlet valve VFO, which is configured to operate on such a medical fluid outlet line 28 to block the fluid upstream of the fluid outlet 27 or allow such fluid to leave the medical generating device 1 via the fluid outlet 27 towards an external medical device.

[0414] The fluid circuit 14 further includes a drain port 29 for draining the amount of fluid reaching from the sixth junction j6. In particular, the drain port 29 is connected to the main fluid line 4 through a drain outlet line 30 and the sixth junction j6. In this case, the plurality of valves further includes a drain valve VDR, which is configured to operate on the drain outlet line 30 to block the fluid from the sixth junction j6 upstream of the main fluid line 4 and the drain port 29, or allow such fluid to leave the medical generating device 1 via the drain port 29.

[0415] In all embodiments, the fluid circuit 14 includes a mixing container outlet line 16 that connects the outlet 13 of the mixing container 11 to the first junction j1 on the main fluid line 4. The plurality of valves includes a mixing container outlet valve VMO, which is configured to operate on the mixing container outlet line 16 to block the fluid from the mixing container 11 upstream of the first junction j1 or allow such fluid to flow to the first junction j1 and the main fluid line 4.

[0416] The medical fluid generating device 1 further includes an auxiliary pressure sensor P1, which is placed on the mixing container outlet line 16, preferably between the first junction element j1 and the mixing container outlet valve VMO.

[0417] According to Figure 1 the illustrated embodiment, the mixing container outlet line 16 is directly connected to the outlet 13 of the mixing container 11, while referring to Figure 2 , 3 and the embodiment shown in 4, the mixing container outlet line 16 is connected to the outlet 13 of the mixing container 11 through a mixing container outlet port 48.

[0418] According to Figure 2 、 3 and the embodiment shown in FIG. 4, the fluid enters and exits the mixing container 11 through the mixing container inlet port 47 and the mixing container outlet port 48, respectively.

[0419] As described above, in addition to or as an alternative to the above-described embodiment, one or more sterilization devices (e.g., UV devices) can be placed at the mixing container inlet line 15 and / or the mixing container outlet line 16.

[0420] In all embodiments, at least one mixing recirculation path R1 (labeled in Figure 1P ) is provided. In this case, the plurality of valves and the control unit 24 are configured to allow at least one fluid contained in the mixing container 11 to be recirculated through the outlet 13, at least a portion of the main fluid line 4 on which the pump 8 is configured to operate, and the inlet 12. In particular, the mixing recirculation path R1 includes the mixing container 11, the outlet 13, the mixing container outlet line 16 that connects the outlet 13 of the mixing container 11 to the first junction point j1 on the main fluid line 4, at least a portion of the main fluid line 4 on which the pump 8 is configured to operate from the first junction point j1 to the sixth junction point j6, the mixing container inlet line 15 that connects the sixth junction point j6 on the main fluid line 4 to the inlet 12 of the mixing container 11, and the inlet 12. More specifically, the mixing recirculation path R1 includes a mixing container outlet valve VMO configured to operate on the mixing container outlet line 16 and a mixing container inlet valve VMI configured to operate on the mixing container inlet line 15. To set the mixing recirculation path R1, the mixing container outlet valve VMO and the mixing container inlet valve VMI are maintained open to recirculate any fluid in the mixing recirculation path R1, while all other valves in the plurality of valves of the medical generation device 1 configured to operate on the fluid circuit 14 that are different from the mixing container outlet valve VMO and the mixing container inlet valve VMI are maintained closed.

[0421] In all embodiments, the fluid circuit 14 includes a main concentrate container inlet line 31 that connects the sixth junction point j6 on the main fluid line 4 to the first main container inlet 43 of the support structure 42. The first main container inlet 43 can be connected to the first port 6 of the main concentrate container 2, as shown in the attached embodiment. As will be described below, the first port 6 can be used as an inlet for supplying fluid to the main concentrate container 2 or as an outlet for removing fluid from the main concentrate container.

[0422] The plurality of valves includes a main concentrate container inlet valve VGI which is configured to operate on the main concentrate container inlet line 31 and is particularly placed between the first main container inlet 43 of the support structure 42 and the sixth junction point j6. The fluid circuit 14 includes a main concentrate container outlet line 32 connecting the second main container inlet 44 of the support structure 42 to the fifth junction point j5 on the main fluid line 4. The second main container inlet 44 of the support structure 42 can be connected to the second port 7 of the main concentrate container 2, as Figure 1 , 2 , 3, 4B and 4C of the embodiments shown.

[0423] In all embodiments, but in Figure 4A the simplified embodiment of, the valves among the plurality of valves include a main concentrate container outlet valve VGO which is configured to operate on the main concentrate container outlet line 32, preferably between the second main container inlet 44 and the fifth junction point j5.

[0424] Particularly considering Figure 1 the embodiment shown, the medical fluid generating device 1 further includes a concentration sensor SG which is configured to sense the concentration of at least one substance to be detected in the fluid flowing towards the first main container inlet 43, particularly when the first main container inlet 43 is connected to the first port 6 of the main concentrate container 2. More particularly, the concentration sensor SG is preferably placed on the main concentrate container inlet line 31, optionally between the main concentrate container inlet valve VGI and the first main container inlet 43. Although the concentration sensor SG is only shown with reference to Figure 1 the embodiment of, such a concentrate sensor can be applied to other parts or lines of the fluid circuit 14 in order to check the concentration of at least one substance to be detected in the fluid flowing along the fluid circuit 14, particularly the concentration towards the concentrate containers 2, 3. In addition, any concentration sensor SG provided on the fluid circuit 14 according to Figure 1 the embodiment shown can also be provided on the fluid circuit 14 according to Figure 2 , 3 , 4A, 4B and 4C of the embodiments shown. The concentration sensor SG can be a glucose concentration sensor.

[0425] The medical fluid device 1 can also include at least one degassing chamber 33. One or more degassing chambers can be used for procedures that require air to be discharged from the fluid circuit 14 or the containers 2, 3, for example, in the case where the container includes a dry concentrate to be dissolved. Of course, in the case of only using a liquid concentrate, any degassing chamber can be optional. This will become apparent from the description of the implementation procedures described below. According to Figure 1In an embodiment, the degassing chamber 33 is placed on the main concentrate container outlet line 32, optionally between the second main container inlet 44 of the support structure 42 and the main concentrate container outlet valve VGO. The degassing chamber 33 divides the main concentrate container outlet line 32 into a first portion 32a extending between the second main container inlet 44 and the inlet of the degassing chamber 33 and a second portion 32b extending between the outlet of the degassing chamber 33 and the fifth junction j5. In particular, the degassing chamber 33 includes a vent 34, which includes a vent line 35, to selectively discharge excess air inside such degassing chamber 33. Optionally, a gas valve VGA is placed on the vent line 35 to selectively block the air passage through such line. In particular, the gas valve VGA is placed on the vent line 35 according to the position inserted between the main concentrate container 2 and the discharge section 1a, more particularly, in the position between the degassing chamber 33 and the discharge section 1a.

[0426] Furthermore, according to Figure 1 the medical fluid generating device 1 of the embodiment shown includes a level sensor associated with the degassing chamber 33 to check the level inside such degassing chamber. Advantageously, the discharge section 1a for discharging the excess air reaching from the degassing chamber 33 can be the same discharge section 1a for discharging the excess air from the mixing container 11. Also in this case, only referring to Figure 1 the degassing chamber 33, the vent 34, the vent line 35 and the gas valve VGA shown in the embodiment of Figure 2 can be applied to the main concentrate container outlet line 32 of the fluid circuit 14 of the medical generating device 1 of the embodiments shown in 3 4B and 4C.

[0427] The fluid circuit 14 includes a first concentrate mixing line 36, which connects the fourth junction j4 placed on the main fluid line 4 to the first main inlet port 43, particularly through the midpoint 31a of the main concentrate container inlet line 31, and the midpoint 31a is preferably placed close to the first main container inlet 43, optionally upstream of the concentrate sensor SG. In this case, the plurality of valves includes a first concentrate mixing valve VGM configured to operate on the first concentrate mixing line 36. The fluid circuit 14 includes an auxiliary concentrate container inlet line 37 connecting the sixth junction j6 on the main fluid line 4 to the first auxiliary container inlet 45. The first auxiliary container inlet 45 can be connected to the first port 9 of the auxiliary concentrate container 3, as shown in the embodiment.

[0428] In all embodiments, the plurality of valves includes a second concentrate container inlet valve VAI, which is configured to operate on the auxiliary concentrate container inlet line 37 and is particularly placed between the first auxiliary container inlet 45 of the support structure 42 and the sixth junction j6.

[0429] The fluid circuit 14 includes a second concentrate container outlet line 40 that connects a second auxiliary container inlet 46 of the support structure 42 to a third junction point j3 on the main fluid line 4. The second auxiliary container inlet 46 of the support structure 42 can be connected to the second port 10 of the auxiliary concentrate container 3, as shown in the embodiments of Figure 1 , 2 , 4B, and 4C.

[0430] Figure 1 The embodiment of is different from the embodiments of Figure 4B and Figure 4C in the profile of the second concentrate outlet line 40. In fact, Figure 4B and Figure 4C 's configuration also provides a degassing chamber placed along the second concentrate outlet line 40. A more detailed description of these two variants is provided in the following description.

[0431] When the first auxiliary container inlet 45 is connected to the first port 9 of the auxiliary concentrate container 3 as shown in Figure 3 , 4 , and 4A, the second auxiliary container inlet 46 is not connected to any of the ports 9, 10 of the auxiliary concentrate container 3, for which the auxiliary concentrate container outlet line 40 becomes a dead-end line and is useless for supplying any fluid to the auxiliary concentrate container 3. This connection is typically achieved when the auxiliary concentrate container 3 contains a liquid concentrate or a liquid concentrate mixture ready for use without any dry concentrate material dissolution procedure, whereby the first port 9 is directly connected to the first auxiliary inlet 45 of the support structure 42.

[0432] According to the embodiments of Figure 1 , 2 , 3, 4B, and 4C, the plurality of valves further includes a second concentrate container outlet valve VAO that is configured to operate on the second concentrate container outlet line 40, preferably between the second auxiliary container inlet 46 and the third junction point j3. The fluid circuit 14 includes a second concentrate mixing line 41 that connects a second junction point j2 placed on the main fluid line 4 to the first auxiliary container inlet 45, particularly through an intermediate point 37a of the auxiliary concentrate container inlet line 37, and the intermediate point 37a is preferably placed close to the first auxiliary container inlet 45. In this case, the valves among the plurality of valves include a second concentrate mixing valve VAM that is configured to operate on the second concentrate mixing line 41.

[0433] Still considering all embodiments, but considering Figure 4AIn the embodiment, the auxiliary concentrate container inlet line 37 includes a common pipe 38 with the main concentrate container inlet line 31. The common pipe 38 is formed between the sixth junction j6 and the branch 39, at which the main concentrate container inlet line 31 and the auxiliary concentrate container inlet line 37 separate from each other. In particular, the common pipe 38 does not include any valves. The main concentrate container inlet valve VGI is configured to operate on the main concentrate container inlet line 31 downstream of the branch 39, and the auxiliary concentrate container inlet valve VAI is configured to operate on the auxiliary concentrate container inlet line 37 downstream of the branch 39.

[0434] In summary, Figure 2 The embodiment shown and Figure 1 The main difference between the embodiment shown is that: in Figure 2 there are no degassing chambers, any vent lines and any gas valves; and a disposable mixing container or bag 11 is provided outside the support structure 42.

[0435] Regarding the first difference mentioned just now, Figure 2 is Figure 1 A simplified schematic diagram of the fluid medical generation device 1 shown. Figure 2 The device 1 shown can be provided with a degassing chamber, corresponding vent lines and corresponding gas valves for one or both of the concentrate outlet lines 32, 40. In this regard, Figure 4B A fluid circuit 14 is shown, which includes both a degassing chamber 33 and an auxiliary degassing chamber 51 placed on the respective outlet lines 32 and 40. The two degassing chambers 33, 51 share a common pipe of the vent line 35. The gas valve VGA selectively allows gas to flow from the degassing chamber 33 to the air discharge section 1a (discharging gas into the external environment or delivering gas to the discharge outlet line 30). The auxiliary gas valve VGA2 selectively allows gas to flow from the auxiliary degassing chamber 51 to the air discharge section 1a.

[0436] Alternatively, in order to allow the air inside the concentrate containers 2, 3 to be discharged, a common degassing chamber and / or a common vent line can be provided, which has a common gas valve connected to the concentrate outlet lines 32, 40 of the two concentrate containers 2, 3. Figure 4C The embodiment is shown, in which the auxiliary concentrate container outlet line 40 leads to a first portion of the main concentrate outlet line 32a and then to the degassing chamber 33. The auxiliary concentrate outlet valve VAO selectively opens and closes the auxiliary concentrate container outlet line 40 according to the operation. In Figure 4CIn the embodiment, the second part 32b of the main concentrate container outlet line 32 is common between the outlet lines 32 and 40 from the main concentrate container 2 and the auxiliary concentrate container 3. The injection point into the main fluid line 4 is also common (the fifth injection point j5). The third injection point j3 is absent in Figure 4C the embodiment.

[0437] Considering Figure 3 the embodiment shown, only the main concentrate container 2 can accommodate the dry concentrate DC.

[0438] Also in this case, Figure 3 the embodiment shown does not provide the degassing chamber, vent line and gas valve necessary to allow the air inside the main container 2 to be discharged, with reference to the main concentrate outlet line 32 in Figure 1 shown. However, as already illustrated for the embodiment shown in Figure 2 shown, Figure 3 also refers to Figure 1 a simplified version of the device 1 shown. According to Figure 3 the embodiment shown, the main concentrate outlet line 32 can be provided with a degassing chamber, an auxiliary degassing chamber, a vent line and a gas valve for discharging the air contained in the main container 2. In other respects, regarding the degassing chamber, valve and line Figure 1 , 4B and any of the embodiments of 4C can also be implemented in Figure 3 the embodiment.

[0439] In addition, in Figure 3 shown, the position of the first junction point j1 is between the fifth junction point j5 and the heater 23. This is to show that the first junction point j1 can be placed in different positions (in any of the disclosed embodiments), i.e., downstream of the second junction point j2 and upstream of the third junction point j3, downstream of the third junction point j3 and upstream of the fourth junction point j4, downstream of the fourth junction point j4 and upstream of the fifth junction point j5, or as Figure 3 shown. In addition, Figure 3 the different positions of the first junction point j1 in the embodiment shown with respect to Figure 1 the position in the embodiment shown do not change the operation of the device 1, since the first junction point j1 is involved in the continuous mixing operation without disturbing the dissolution and recirculation of the obtained liquid mixture ML. Therefore, all the steps of the dry concentrate dissolution procedure illustrated by using Figures 1A to 1K shown are also the same for Figure 3 the embodiment shown.

[0440] According to Figure 1 the embodiment shown with reference to Figure 1F , 1K, the control unit 24 is configured to interact with the pump 8 and the plurality of valves to set at least one concentrate recirculation path Z6, X5, wherein the valves of the plurality of valves are configured to allow fluid contained in one of the main concentrate container 2 and / or the auxiliary concentrate container 3 and / or fluid generated therein to recirculate through the following parts: the first ports 6, 9, at least a part of the main fluid line 4 on which the pump 8 is configured to operate, and the second ports 7, 10.

[0441] In particular, considering Figure 1F , the concentrate recirculation path includes a first concentrate recirculation path Z6, which includes the main concentrate container 2, the second port 7, the second main container inlet 44, the first part 32a of the main concentrate container outlet line 32, the degassing chamber 33, the second part 32b of the main concentrate outlet line 32, the fifth junction j5 on the main fluid line 4, the corresponding part of the main fluid line 4 from the fifth junction j5 to the sixth junction j6 on which the pump 8 is configured to operate, the main concentrate container inlet line 31 connecting the sixth junction j6 on the main fluid line 4 to the first port 6 of the main concentrate container 2 via the first main container inlet 43, and the first port 6.

[0442] In this case, the main concentrate container outlet valve VGO is configured to operate on the second part 32b of the main concentrate container outlet line 32, and the main concentrate container inlet valve VGI is configured to operate on the main concentrate container inlet line 31. When the control unit 24 controls the plurality of valves to set the first concentrate recirculation path Z6, the main concentrate container outlet valve VGO and the main concentrate container inlet valve VGI remain open to allow fluid to recirculate in the first concentrate recirculation path Z6, while the other valves of the plurality of valves configured to operate on the fluid circuit 14 remain closed to keep the fluid flowing along the first concentrate recirculation path Z6.

[0443] When the main concentrate container 2 (as in Figure 4 the illustrated embodiment) contains fluid ready for mixing and / or use, such a main container 2 does not have an outlet port 7 and is appropriately directly connected to the first main container inlet 43 through the inlet port 6. In this case, the first concentrate recirculation path Z6 is never set, since the fluid inside the main concentrate container 2 can only flow out towards the main fluid line 4. When the first concentrate mixing valve VGM is opened and the pump 8 is activated, the fluid placed inside the main concentrate container 2 is suctioned by the pump 8 to flow into the fluid circuit 14 and flows along the part of the main fluid 4 extending between the fourth junction j4 and the sixth junction j6 to reach the mixing container inlet line 15.

[0444] Considering Figure 1K , the concentrate recirculation path includes a second concentrate recirculation path X5, which includes an auxiliary concentrate container 3, a second port 10, a second auxiliary container inlet 46, an auxiliary concentrate container outlet pipeline 40, a third junction j3 on the main fluid pipeline 4, the corresponding part of the main fluid pipeline 4 where a pump 8 configured to operate thereon extends from the third junction j3 to the sixth junction j6, and an auxiliary concentrate container inlet pipeline 37 connecting the sixth junction j6 to the auxiliary concentrate container 3 via a first auxiliary container inlet 45 and the first port 9 of the auxiliary concentrate container.

[0445] As Figure 4B and Figure 4C shown, the auxiliary concentrate container outlet pipeline 40 may be provided with an auxiliary degassing chamber 51 ( Figure 4B ) or connected to a degassing chamber 33 ( Figure 4C ); an auxiliary gas valve VGA2, a vent pipeline 35a, and a vent 34 ( Figure 4B ) configured to operate on the main concentrate container outlet pipeline 32 may be provided, or the pipeline may be connected to the degassing chamber 33 of the main concentrate container outlet pipeline 32 by means of the connection shown in Figure 4C .

[0446] An auxiliary concentrate container outlet valve VAO is configured to operate on the auxiliary concentrate container outlet pipeline 40, and an auxiliary concentrate container inlet valve VAI is configured to operate on the auxiliary concentrate container inlet pipeline 37. When the control unit (24) controls the plurality of valves to set the second concentrate recirculation path X5, the auxiliary concentrate container outlet valve VAO and the auxiliary concentrate container inlet valve VAI remain open to allow the fluid to recirculate in the second concentrate recirculation path X5, while the other valves of the plurality of valves configured to operate on the fluid circuit 14 remain closed to keep the fluid flowing along the second concentrate recirculation path X5.

[0447] When the auxiliary concentrate container 3 (as in the embodiments shown in Figure 3 , 4 and 4A) contains a fluid ready for mixing and / or use, such an auxiliary concentrate container 3 is not provided with an outlet port 10 and is directly connected to the first auxiliary container inlet 45 through the inlet port 9 appropriately. In this specific case, the second concentrate recirculation path X5 cannot be set because the fluid inside the auxiliary concentrate container 3 can only flow out towards the main fluid pipeline 4. When the second concentrate mixing valve VAM is opened and the pump 8 is activated, the fluid placed inside the auxiliary concentrate container 3 is sucked by the pump 8 to flow into the fluid circuit 14, flows along the part of the main fluid pipeline 4 extending between the second junction j2 and the sixth junction j6, and reaches the mixing container inlet pipeline 15.

[0448] When the concentrate containers 2, 3 contain concentrate substances to be dissolved and / or diluted in powder / granule form and liquid form, the control unit 24 is configured and / or programmed to first set at least one recirculation path Z6, X5, preferably both Z6, X5 first, and subsequently set the mixing recirculation path R1. Dry concentrate dissolution program

[0449] Considering at least one of the concentrate containers 2, 3 that contains a dry concentrate DC (such as powder or granules), in particular the main concentrate container 2, the control unit 24 is configured to run a dry concentrate dissolution program DCDP( Figure 5 ), which includes sending a dissolution liquid DL (such as water) to such a concentrate container 2, 3 in order to dissolve the DC and form a concentrate mixture CM, which is a liquid or a liquid concentrate.

[0450] Advantageously, the DCDP includes heating the DL and / or the CM by means of the heater 23. Preferably, the DL is heated to a temperature sufficient to completely dissolve a specific dry concentrate within a specific time period. Below, temperature values for glucose are provided solely for illustrative purposes. For different dry concentrates, such as for buffer / electrolyte powders, some heating is also expected, but not at as high a temperature as for glucose. In other words, glucose tests are performed on the disclosed temperatures. For buffer concentrates, a lower temperature is expected to be required.

[0451] For glucose, the DL is heated to at least 60 °C, more specifically to at least 70 °C, and the CM is heated to at least 40 °C, more specifically to at least 50 °C.

[0452] The DCDP includes at least one concentrate mixture recirculation step CMRS, CMRS-Aux, in which the control unit 24 sets the corresponding concentrate recirculation paths Z6, X5 and recirculates the CM for homogenization.

[0453] As Figure 6 Schematically shown, the DCDP includes an exhaust step AES, a main fluid line perfusion step MFPS, a recirculation path perfusion step RPPS, a dissolution liquid filling step DLFS, a concentrate mixture recirculation step CMRS, and an optional concentration test step CTS. The DLFS can include two (or more) different steps, namely, a first dissolution liquid filling step DLFS’ and a second dissolution liquid filling step DLFS”. Optionally, in the DCDP, at least the exhaust step AES, the dissolution liquid filling step DLFS (including DLFS’ and DLFS”) and the concentrate mixture recirculation step CMRS are preferably executed by the control unit 24 in chronological order.

[0454] The dry concentrate dissolution procedure will be described in more detail with reference to the sequence of FIGS. 1A to 1F.

[0455] The purpose of AES is to expel air from the dry powder containers (main concentrate container 2 and / or auxiliary concentrate container 3) to fill the corresponding degassing chambers 33, 51 with air. This is to ensure that the air volume does not contribute to the dead volume of water. The exhaust fluid path Z1 is shown in Figure 1A ; the control unit 24 controls the plurality of valves to set the exhaust flow path Z1 so as to expel air from the main concentrate container 2, and controls the pump 8 to remove air from such main concentrate container 2. In the exhaust flow path Z1, the plurality of valves are configured to allow the air contained in the main concentrate container 2 to flow into the main concentrate container outlet line 32 and into the degassing chamber 33 when the pump 8 is activated. The main concentrate container outlet valve VGO acting on the main concentrate container outlet line 32 and the discharge valve VDR acting on the discharge outlet line 30 are opened, while all other valves among the plurality of valves configured to operate on the fluid circuit 14 are closed. Advantageously, during AES, the control unit 24 operates the pump 8 at a preset pumping rate for a predetermined period of time and stops the pump 8 after the predetermined period of time has elapsed. During AES, pumping is performed until a low liquid level in the degassing chamber is ensured. In an exemplary embodiment for testing purposes, the preset pumping rate is set to approximately 300 ml / min and the predetermined period of time is set to 20 s.

[0456] Moving on to Figure 1B , the purpose of the main fluid line priming step MFPS is to prime the main fluid path (j5–j6) after exhaust; the control unit 24 controls the plurality of valves to set the main fluid line priming path Z2 and activates the pump 8 to prime the main fluid line 4, particularly after AES. Specifically, in the main fluid line priming path Z2, the valves among the plurality of valves are configured to allow the dissolution liquid DL (e.g., water) to enter the main fluid line 4 and flow towards the discharge outlet line 30 under the action of the pump 8. In this case, the water inlet valve VWI placed on the main fluid line 4 and the discharge valve VDR acting on the discharge outlet line 30 are opened, while the other valves among the plurality of valves different from the water inlet valve VWI and the discharge valve VDR remain closed.

[0457] During MFPS, the control unit 24 operates the pump 8 at a preset pumping rate until a predetermined pumping volume is reached, and stops the pump 8 after the predetermined pumping volume has been reached. The pump 8 operates until the predetermined pumping volume is greater than the volume of the main fluid line from the water inlet valve VWI to the sixth junction j6. Optionally, a safety factor z (e.g., 1.5 - 2) of the main fluid line volume is considered to ensure that no air remains between the fourth junction j4 and the sixth junction j6. In an illustrative embodiment for testing purposes, the preset pumping rate is about 300 ml / min, and the predetermined pumping volume is at least 100 ml.

[0458] Go to Figure 1C , the purpose of RPPS is to perfuse the recirculation fluid path upstream of the bag (i.e., the fluid path between the sixth junction j6 and the fourth junction j4), and direct any existing air to the main fluid path (including between the fourth junction j4 and the sixth junction j6). The control unit 24 controls the valves among the plurality of valves to set the recirculation perfusion path Z3, and activates the pump 8 to perfuse the recirculation perfusion path Z3, especially after AES and MFPS. Considering the recirculation perfusion path Z3, the valves among the plurality of valves are configured to allow fluid to circulate from the sixth junction j6 on the main fluid line 4 towards the main concentrate container inlet line 31, enter the first concentrate mixing line 36, reach the fourth junction j4 on the main fluid line 4, enter at least a portion of the main fluid line 4 where the pump 8 is activated, and reach the sixth junction j6.

[0459] In particular, the valves among the plurality of valves are configured to allow fluid to circulate through the main concentrate container inlet valve VGI acting on the main concentrate container inlet line 31 and the first concentrate mixing valve VGM acting on the first concentrate mixing line 36 when such valves VGI, VGM are maintained open, while the other valves among the plurality of valves configured to operate on the fluid circuit 14 and different from the main concentrate container inlet valve VGI and the first concentrate mixing valve VGM are maintained closed.

[0460] During RPPS, the control unit 24 operates the pump 8 at a preset pumping rate until a predetermined pumping volume is reached, and stops the pump 8 after the predetermined pumping volume has been reached. The predetermined pumping volume for pumping is less than the volume of the main fluid line between the fourth junction j4 and the sixth junction j6, but also greater than the volume in the remaining part of the recirculation perfusion path Z3 (i.e., the total volume of the recirculation perfusion path minus the volume of the main fluid line between the fourth junction j4 and the sixth junction j6). In an illustrative embodiment for testing purposes, the preset pumping rate is about 300 ml / min, and the predetermined pumping volume is at least 100 ml.

[0461] The recirculation path perfusion step allows air that may be contained in the pipeline to be repositioned to the main fluid line 4. After the air is repositioned, the main fluid line is perfused again by repeating the MFPS (see Figure 1B ). The purpose of this additional perfusion step is to reperfuse the main fluid line from j5 to j6 after the air repositioning. This step ensures that the water delivery fluid path (j5 – pump 8 – VGI – j4) to the concentrate container is perfused so that its dead volume can be subtracted from the nominal water volume to be added.

[0462] The purpose of the DLFS is to fill a portion of the expected total water volume while establishing and saving a reference pressure value (hereinafter referred to as P2_base) indicating the median filtration pressure P2 value (average pressure) present in the pipeline during the first dissolved liquid filling step. When further filling is performed using the pressure feedback from the sensor P2, the reference pressure value (P2_base) will be used as the base pressure value. Since the gas valve VGA is open, air can freely flow out via the degassing chamber 33 when the liquid level in the first concentrate container 2 rises. The control unit 24 controls the valves among the plurality of valves to set the first dissolved liquid filling path Z4 ( Figure 1D ), and controls the pump 8 to fill a portion of the expected total dissolved liquid volume in the first concentrate container 2, particularly after AES, after MFPS, and after RPPS. More specifically, in the first dissolved liquid filling path Z4, the valves among the plurality of valves are configured to allow the dissolved liquid DL (e.g., water) to enter the main concentrate container 2.

[0463] Preferably, the first dissolved liquid filling path Z4 includes the main fluid line 4, the main concentrate container inlet line 31, the first main container inlet 43, the first port 6 of the main concentrate container 2, the main concentrate container 2, the second port 7 of the main concentrate container 2, the first part 32a of the main concentrate container outlet line 32, the degassing chamber 33, and the vent 34 of the degassing chamber. To set the first dissolved liquid filling path Z4, the water inlet valve VWI placed on the main fluid line 4, the main concentrate container inlet valve VGI on the main concentrate container inlet line 31, and the gas valve VGA on the vent 34 remain open, while the other valves among the plurality of valves configured to operate on the fluid circuit 14 and different from the water inlet valve VWI, the main concentrate container inlet valve VGI, and the gas valve VGA remain closed.

[0464] During DLFS’, the control unit 24 operates the pump 8 at a preset pumping rate and ends the first dissolved liquid filling step after the liquid level in the degassing chamber 33 reaches a preset high liquid level. The aim is to maintain the water filling until all the air in the main concentrate container 2 has been pushed out of the bag and the degassing chamber 33. It is noted that the control unit 24 is configured to receive pressure data in the first dissolved liquid filling path Z4 during at least a part of the first dissolved liquid filling step and determine a reference pressure value P2_base indicative of the average pressure. The pressure is read by a pressure sensor P2 on the mixing container inlet pipeline, and the pressure borne by this pressure sensor is the same as the pressure present in the first dissolved liquid filling path Z4. Advantageously, the pressure data and / or the reference pressure value P2_base are stored in a memory associated with the control unit 24; as described above, the reference pressure value P2_base is the reference pressure subsequently used for further filling the concentrate container.

[0465] During the DLFS’ step, the control unit 24 operates the heater 23 on the main fluid pipeline 4 to heat the dissolved liquid to a temperature sufficient to support effective dissolution in a later step. In an illustrative embodiment for testing purposes, the temperature is at least 70 °C and optionally at least 80 °C.

[0466] Go to Figure 1E , the aim of DLFS” is to maintain the water filling until a certain overpressure has been established in the main concentrate container 2. This ensures that the top outlet position does not collapse during recirculation and passive degassing can be achieved during recirculation. The control unit 24 controls the plurality of valves to set the second dissolved liquid filling path Z5 and controls the pump 8 to fill up to the expected total volume of dissolved liquid in the main concentrate container 2, particularly after DLFS’. In the second dissolved liquid filling path Z5, the valves among the plurality of valves are configured to allow the dissolved liquid DL (i.e., water arriving from the inlet point 5) to enter the main concentrate container 2.

[0467] In particular, the second dissolved liquid filling path Z5 includes a part of the main fluid pipeline 4, the sixth junction j6, the main concentrate container inlet pipeline 31, the first main container inlet 43, the first port 6 of the main concentrate container 2, the main concentrate container 2, the second port 7 of the main concentrate container 2, the second main container inlet 44, a first part 32a of the concentrate container outlet pipeline 32, the degassing chamber 33, and a part of a second part 32b of the concentrate container outlet pipeline 32 upstream of the main concentrate container outlet valve VGO. To set the second dissolved liquid filling path Z5, the water inlet valve VWI placed on the main fluid pipeline 4 and the main concentrate container inlet valve VGI placed on the main concentrate container inlet pipeline 31 are opened, while the other valves among the plurality of valves different from the water inlet valve VWI and the main concentrate container inlet valve VGI are closed.

[0468] Specifically, during "DLFS", the control unit 24 operates the pump 8 at a preset pumping rate until a predetermined pressure in the second dissolved liquid filling path Z5 is reached, and stops the pump 8 after the predetermined pressure has been reached (the predetermined pressure is particularly the reference pressure value (P2_base) in the second dissolved liquid filling path Z5 plus the overpressure value); in an illustrative embodiment for testing purposes, the preset pumping rate is about 300 ml / min, and the overpressure value is 40 mmHg.

[0469] Furthermore, during "DLFS", the control unit 24 operates the heater 23 on the main fluid line 4 to heat the dissolved liquid to at least 70 °C, and optionally to at least 80 °C.

[0470] During Figure 1F In the steps shown, the purpose of CMRS is to completely dissolve the dry powder (e.g., glucose) and mix the concentrate into a homogeneous composition. During the recirculation process, there is a function to degas the degassing chamber 33 from the accumulated air. If a low liquid level is detected in the degassing chamber 33, the recirculation is stopped and the gas valve VGA is opened so that air is pushed out by the overpressure in the main concentrate container 2 until a high liquid level is detected in the degassing chamber 33. The control unit 24 controls the plurality of valves to set the concentrate recirculation path Z6 and controls the pump 8 to recirculate CM to dissolve DC and uniformly mix the concentrated mixture CM.

[0471] CMRS is particularly performed after "DLFS'" and after "DLFS". During CMRS, the control unit 24 operates the pump 8 at a preset pumping rate for a predetermined period of time and stops the pump 8 after the predetermined period of time has passed. Furthermore, during CMRS, the control unit 24 operates the heater 23 on the main fluid line 4 to heat the concentrated mixture CM. The combination of time, flow rate, and temperature is selected to effectively dissolve the powder and homogenize the solution. For example, in an illustrative embodiment for testing purposes, the preset pumping rate is about 300 ml / min, the predetermined period of time is 600 s, and the temperature is set to at least 50 °C and optionally at least 60 °C.

[0472] Advantageously, the control unit 24 is configured to perform an optional concentration test step CTS to measure the concentration of CM and compare the measured concentration with the expected concentration of the concentrated mixture CM. The control unit 24 is configured to measure the concentration during CMRS. The purpose is to test the concentration of the (glucose) concentrate by comparing its conductivity reduction effect with the expected conductivity when a clearly defined volume of glucose concentrate is added to a clearly defined electrolyte plus aqueous solution. Dry concentrate dissolution procedure starting from the auxiliary container

[0473] Instead of starting from the main concentrate container 2, the DCDP can start from an auxiliary concentrate container 3 that houses a dry concentrate (such as powder or granules).

[0474] In this case, the control unit 24 is configured to run the dry concentrate dissolution program DCDP by determining a dissolution liquid DL (e.g., water), which is sent to the auxiliary concentrate container 3 to dissolve the corresponding dry concentrate DC and form a corresponding CM, which is a liquid.

[0475] In this particular case, the DCDP also includes heating the DL and / or the CM by a heater 23. Preferably, the DL is heated to at least 60 °C and more specifically to at least 70 °C, and the concentrate mixture is heated to at least 40 °C and more specifically to at least 50 °C.

[0476] The DCDP includes at least one auxiliary concentrate mixture recirculation step CMRS-Aux, in which the control unit 24 sets a corresponding concentrate recirculation path X5 and recirculates the CM for homogenization.

[0477] Considering Figure 6 the detailed schematic block diagram shown in, the DCDP includes one or more of an auxiliary exhaust step AES-Aux, an auxiliary perfusion step MFPS-Aux of the main fluid line, an auxiliary recirculation path perfusion step RPPS-Aux, an auxiliary dissolution liquid filling step DLFS-Aux, an auxiliary concentrate mixture recirculation step CMRS-Aux, and an auxiliary concentration test step CTS-Aux.

[0478] The DLFS-Aux can include two different steps, namely, an auxiliary first dissolution liquid filling step DLFS'-Aux and an auxiliary second dissolution liquid filling step DLFS''-Aux.

[0479] Optionally, in the DCDP, at least the AES-Aux, the DLFS-Aux (including the DLFS'-Aux and the DLFS''-Aux), and the CMRS-Aux are executed by the control unit 24 in chronological order.

[0480] The dry concentrate dissolution program for the dry concentrate in the auxiliary concentrate container 3 will be described in more detail with reference to FIGS. 1G to 1K of the figure sequence.

[0481] Referring to Figure 1G the AES-Aux shown in, the control unit 24 controls the plurality of valves to set an auxiliary exhaust flow path X1 to discharge air from the auxiliary concentrate container 3, and controls the pump 8 to remove air from such an auxiliary concentrate container 3.

[0482] In the auxiliary exhaust flow path X1, when the pump 8 is configured to operate, the plurality of valves are configured to allow air contained in the auxiliary concentrate container 3 to flow into the auxiliary concentrate container outlet line 40 and into the degassing chamber (see Figure 4B ) or into the degassing chamber 33 (see Figure 4C ). The auxiliary concentrate container outlet valve VAO acting on the auxiliary concentrate container outlet line 40 and the discharge valve VDR acting on the discharge outlet line 30 are opened, while the other valves among the plurality of valves configured to operate on the fluid circuit 14 are closed.

[0483] Advantageously, during AES-Aux, the control unit 24 operates the pump 8 at a preset pumping rate for a predetermined period of time and stops the pump 8 after the predetermined period of time has elapsed. During AES-Aux, pumping is performed until a low level in the degassing chamber is ensured. In an illustrative embodiment for testing purposes, the preset pumping rate is about 300 ml / min and the predetermined period of time is 20 s.

[0484] MFPS-Aux is controlled by the control unit 24, which controls the plurality of valves to set the auxiliary main fluid line perfusion path and controls the pump 8 to perfuse the main fluid line 4, particularly after the auxiliary exhaust step AES-Aux.

[0485] Since the auxiliary main fluid line perfusion path is the same as the main fluid line perfusion path Z2 shown in Figure 1B , the reference numeral Z2 and Figure 1B are used to identify the auxiliary main fluid line perfusion path EAS-Aux. In particular, in the auxiliary main fluid line perfusion path, the valves among the plurality of valves are configured to allow the dissolved liquid DL (e.g., water) to enter the main fluid line 4 and flow towards the discharge outlet line 30 under the action of the pump 8.

[0486] In this case, the water inlet valve VWI placed on the main fluid line 4 and the discharge valve VDR acting on the discharge outlet line 30 are opened, while the other valves different from the water inlet valve VWI and the discharge valve VDR among the plurality of valves remain closed.

[0487] During MFPS-Aux, the control unit 24 operates the pump 8 at a preset pumping rate to a predetermined pumping volume and stops the pump 8 after the predetermined pumping volume has been reached. The pump 8 operates until the predetermined pumping volume is greater than the volume of the main fluid line from the water inlet valve VWI to the sixth junction point j6.

[0488] Go to Figure 1H, RPPS-Aux is controlled by the control unit 24, which controls the valves among the plurality of valves to set the auxiliary recirculation perfusion path X2, and controls the pump 8 to perfuse the auxiliary recirculation perfusion path X2, particularly after AES-Aux and after MFPS-Aux.

[0489] In the auxiliary recirculation perfusion path X2, the valves among the plurality of valves are configured to allow fluid to circulate from the sixth junction point j6 on the main fluid line 4 towards the auxiliary concentrate container inlet line 37, enter the auxiliary first concentrate mixing line 41, reach the second junction point j2 on the main fluid line 4, enter at least a portion of the main fluid line 4 where the pump 8 is activated, and reach the sixth junction point j6. In particular, the valves among the plurality of valves are configured to allow fluid to circulate through the auxiliary concentrate container inlet valve VAI acting on the auxiliary concentrate container inlet line 37 and the second concentrate mixing valve VAM acting on the second concentrate mixing line 41 when such valves VAI, VAM are maintained open, while the other valves among the plurality of valves configured to operate on the fluid circuit 14 and different from the auxiliary concentrate container inlet valve VAI and the second concentrate mixing valve VAM are maintained closed.

[0490] During RPPS-Aux, the control unit 24 operates the pump 8 at a preset pumping rate to reach a predetermined pumping volume, and stops the pump 8 after the predetermined pumping volume has been reached. The predetermined pumping volume for pumping is less than the volume of the main fluid line between the fourth junction point j4 and the sixth junction point j6, but is also greater than the volume in the remaining part of the recirculation perfusion path Z3 (i.e., the total volume of the recirculation perfusion path minus the volume of the main fluid line between the fourth junction point j4 and the sixth junction point j6).

[0491] As Fig. 1I shown, DLFS’-Aux is controlled by the control unit 24, which controls the valves among the plurality of valves to set the auxiliary first dissolved liquid filling path X3 and controls the pump 8 to fill a part of the expected total dissolved liquid volume in the auxiliary concentrate container 3, particularly after AES-Aux, after MFPS-Aux, and after RPPS-Aux. More specifically, in the auxiliary first dissolved liquid filling path X3, the valves among the plurality of valves are configured to allow DL to enter the auxiliary concentrate container 3.

[0492] Preferably, the auxiliary first dissolved liquid filling path X3 includes the main fluid line 4, the auxiliary concentrate container inlet line 37, the first auxiliary container inlet 45, the first port 9 of the auxiliary concentrate container 3, the auxiliary concentrate container 3, the second port 10 of the auxiliary concentrate container 3, the auxiliary concentrate container outlet line 40, at Fig. 1I not shown (but at Figure 4Bshown) the auxiliary degassing chamber 51 and the corresponding vent line, or the degassing chamber 33 and the vent 34 of such a degassing chamber (as shown in Figure 4C ). In order to set the auxiliary first dissolved liquid filling path X3, the water inlet valve VWI placed on the main fluid line 4, the auxiliary concentrate container inlet valve VAI on the auxiliary concentrate container inlet line 37, corresponding to the degassing chamber 51 (see Figure 4B ) or the degassing chamber 33 (see Figure 4C , and in this configuration the valve VAO is also open), the auxiliary gas valve VGA2 remains open, while the other valves among the plurality of valves configured to operate on the fluid circuit 14 and different from the valves just mentioned remain closed.

[0493] During DLFS’-Aux, the control unit 24 operates the pump 8 at a preset pumping rate to a predetermined pressure and / or a predetermined pumped volume. It should be noted that DLFS’-Aux includes two steps: in the first water filling step, the control unit 24 is configured to stop the pump when the predetermined pumped volume has been reached; in the second water filling step, the control unit 24 is configured to receive the pressure data in the first dissolved liquid filling path and stop the pump when the pressure reaches a predetermined reference pressure value P2_base. The control unit 24 is configured to end DLFS’-Aux after the liquid level in the auxiliary degassing chamber 51 or the degassing chamber 33 reaches a preset high level. For example, in a test embodiment, the preset pumping rate is about 300 ml / min, and the predetermined pumped volume is at least 600 ml, and then water is pumped until the predetermined reference pressure P2_base is reached.

[0494] During DLFS’-Aux, the control unit 24 operates the heater 23 on the main fluid line 4 to heat the DL to a temperature sufficient to support effective dissolution in a later step.

[0495] In addition, during DLFS’-Aux, the control unit 24 receives the pressure data in the auxiliary first dissolved liquid filling path X3 from the pressure sensor P2. Advantageously, the pressure data is stored in a memory associated with the control unit 24. In particular, the reference pressure value (P2_base) is stored in such a memory.

[0496] Moving on to Figure 1J , DLFS”-Aux is controlled by the control unit 24, which controls the plurality of valves to set the auxiliary second dissolved liquid filling path X4 and controls the pump 8 to fill the expected total dissolved liquid volume into the auxiliary concentrate container 3 after DLFS’-Aux.

[0497] In the auxiliary second dissolution liquid filling path X4, the valve among the plurality of valves is configured to allow the dissolution liquid DL (i.e., water arriving from the inlet point 5) to enter the auxiliary concentrate container 3. In particular, the auxiliary second dissolution liquid filling path X4 includes a main fluid pipeline 4, a sixth junction j6, an auxiliary concentrate container inlet pipeline 37, a first auxiliary container inlet 45, a first port 9 of the auxiliary concentrate container 3, the auxiliary concentrate container 3, a second port 10 of the auxiliary concentrate container 3, a second auxiliary container inlet 46, an auxiliary concentrate container outlet pipeline 40, an auxiliary degassing chamber 51 (see Figure 1J not shown in Figure 4B ) or a degassing chamber 33 (see Figure 4C ), and a portion of the auxiliary concentrate container outlet pipeline 40 upstream of the auxiliary concentrate container outlet valve VAO. To set the auxiliary second dissolution liquid filling path X4, the water inlet valve VWI placed on the main fluid pipeline 4 and the auxiliary concentrate container inlet valve VAI placed on the auxiliary concentrate container inlet pipeline 37 are opened, while the other valves among the plurality of valves different from the water inlet valve VWI and the auxiliary concentrate container inlet valve VAI are closed.

[0498] In particular, during DLFS”-Aux, the control unit 24 operates the pump 8 at a preset pumping rate to reach a predetermined pressure in the auxiliary second dissolution liquid filling path X4, and stops the pump 8 after the predetermined pressure has been reached; optionally, the predetermined pressure is a reference pressure value (P2_base) in the auxiliary second dissolution liquid filling channel X4 plus an overpressure value such as 40 mmHg.

[0499] In addition, during DLFS”-Aux, the control unit 24 operates the heater 23 on the main fluid pipeline 4 to heat the dissolution liquid to, for example, at least 70 °C and optionally at least 80 °C.

[0500] As Figure 1K shown, CMRS-Aux is controlled by the control unit 24, which controls the plurality of valves to set the auxiliary concentrate recirculation path X5 and controls the pump 8 to recirculate CM to dissolve DC and uniformly mix the concentrate mixture CM. CMRS-Aux is performed after DLFS’-Aux and after DLFS”-Aux. During CMRS-Aux, the control unit 24 operates the pump 8 at a preset pumping rate for a predetermined period of time, and stops the pump 8 after the predetermined period of time has passed.

[0501] In addition, during CMRS-Aux, the control unit 24 operates the heater 23 on the main fluid line 4 to heat the CM to a temperature sufficient to support effective dissolution in a later step. Advantageously, the control unit 24 is configured to perform an auxiliary concentration test step CTS-Aux to measure the concentration of the CM and compare the measured concentration with the expected concentration of the CM. Optionally, the control unit 24 is configured to measure the concentration during CMRS-Aux. Dry concentrate dissolution procedure performed on two serially-connected concentrate containers

[0502] If according to Figure 1 the illustrated embodiment, the DCDP for dissolving and / or diluting the dry concentrate should be performed in each of the concentrate containers 2, 3 of the fluid medical generation device 1. The DCDP will first be run by the control unit 24 on a single concentrate container 2, 3 and then on the other concentrate container 2, 3, with one or more evacuation and / or flushing and / or perfusion steps inserted on at least the main fluid line 4 of the fluid circuit 14.

[0503] In particular, considering the starting situation where the dry concentrate is contained in both the main concentrate container 2 and the auxiliary concentrate container 3, the DCDP runs according to the DCDP associated with the main concentrate container 2 as described above, or according to the DCDP associated with the auxiliary concentrate container 3 as described above, to form an auxiliary liquid concentrate. Subsequently, at least one inserted step occurs, such as evacuating and / or flushing and / or perfusing at least the main fluid line 4 of the fluid circuit 14.

[0504] Generally, to achieve this, the water inlet valve VWI and the discharge valve VDR are moved to the open state by the control unit 24, while all other valves in the plurality of valves of the fluid circuit 14 are maintained closed, and the pump 8 is activated to provide a water flow from the inlet point 5 to the discharge port 29. Once the inserted step is completed, the DCDP can be run again on the concentrate containers 2, 3 that have not yet been involved in the DCDP to form the main liquid concentrate. Further inserted steps can be performed, as in the previous step, to prepare for the subsequent liquid concentrate mixing procedure LCMP.

[0505] The DCDP is required each time the DC is contained inside the concentrate containers 2, 3, even in the starting situation where one of the concentrate containers 2, 3 contains the DC, as Figure 3 shown in the illustrated embodiment, while the other contains the auxiliary liquid concentrate LC', which does not require any dissolution operation. According to this starting situation, the DCDP runs only with respect to the concentrate containers 2, 3 containing the DC, since the liquid concentrate contained in the other concentrate containers 2, 3 is ready to be diluted and / or mixed during the successive liquid concentrate mixing procedure LCMP. Liquid concentrate mixing procedure

[0506] Mixing to obtain the final PD fluid is always carried out by the liquid concentrate LC, which is prefabricated or prepared from the above-mentioned dry concentrate DC.

[0507] In summary, the mixing sequence is a three-step method, in which first a correct mixture of the liquid concentrate (main electrolytes and buffer) from the auxiliary concentrate container 3 with added water is established during two steps with conductivity feedback, and subsequently another liquid concentrate (glucose) from the main concentrate container 2 is added by volume in the final step.

[0508] It is necessary to know the actual concentration of the concentrate in order to be able to perform volume quantification in the mixing sequence. To test the concentration of the glucose concentrate and the electrolyte concentrate, the following sequence can be used: 1. Fill a certain volume of water into the mixing container; 2. Fill a part of the known volume of water (W) in the electrolyte concentrate (E) into the mixing container; 3. Recirculate the mixed solution and sense the conductivity when uniformity is detected (e.g., the conductivity change is below a threshold); 4. Calculate the actual concentration of the electrolyte concentrate based on the sensed conductivity and the volume ratio of E to W; 5. Add a part of the known volume of W + E in the glucose concentrate to the mixing container; 6. Recirculate the mixed solution and sense the conductivity when uniformity is detected (e.g., the conductivity change is below a threshold); 7. Calculate the actual concentration of the glucose concentrate based on the sensed conductivity and the conductivity and volume before glucose addition.

[0509] Based on the desired batch volume and glucose concentration set by the user, calculate the initial formulation of water and concentrate with nominal volumes. Moreover, calculate the nominal conductivity for different mixing steps at this point. Subsequently, add the concentrate with the nominal volume together with 80% of the nominal water volume to the mixing container. After recirculating and mixing to uniformity, recalculate the volume of the remaining water and glucose concentrate to be added based on the deviation of the conductivity from the nominal value. This method makes the mixing system robust to deviations in the concentration of A concentrate.

[0510] The flexible mixing container / bag 11 (see Figures 2 to 4 ) and the rigid mixing container 11 (see Figure 1) The main difference between them is that the flexible hybrid container / bag can be emptied of fluid without air entering. However, the rigid mixing container requires air to replace the emptied fluid. This means that after the flexible mixing bag 11 is completely discharged, the recirculation fluid path will contain a specific volume of water. This dead volume must be accounted for by subtracting it from the first volume of water added during mixing. It should be noted that when attaching a new mixing bag containing air, it needs to be emptied of air, and the air present downstream of the mixing bag must be replaced with water. In a rigid tank system, air replaces the discharged fluid, so the recirculation fluid path can be completely discharged. In this case, the dead volume will be close to zero and may not need to be considered.

[0511] Returning to the drawings and the procedure, as Figure 7 Schematically shown, the control unit 24 is further configured to run a liquid concentrate mixing program LCMP, which includes sending an auxiliary liquid concentrate LC’ from the main concentrate container 2 or the auxiliary concentrate container 3 to the mixing container 11. The liquid concentrate mixing program LCMP also includes sending a dissolving liquid DL (e.g., water) to the mixing container 11 to dilute the liquid concentrate to a desired dilution value, and subsequently sending the main liquid concentrate LC” from the other of the main concentrate container 2 and the auxiliary concentrate container 3. The dialysis fluid is obtained after appropriately mixing the liquids.

[0512] Generally, the liquid concentrate mixing step LCMP includes heating the diluting liquid DL (i.e., water) and / or the liquid mixture DM by the heater 23. Advantageously, the DL is heated to at least 30 °C, and more specifically to at least 37 °C, the diluting liquid mixture DM is heated to at least 30 °C, and more specifically to at least 37 °C.

[0513] More specifically, as Fig. 9 Schematically shown, the liquid concentrate mixing program LCMP includes at least one dilution mixture recirculation step RS, in which the control unit 24 sets the mixing recirculation path R1 and recirculates the corresponding diluting liquid mixture DM to homogenize it.

[0514] In particular, the liquid concentrate mixing program LCMP includes one or more of the following steps: - mixing container discharge step MCDS; - mixing container filling step MCFS for rinsing; - perfusion step PSMF of the main fluid line; - first filling step FL’ of filling the auxiliary liquid concentrate LC’ (or the first dilution mixture DM’) arriving from the auxiliary concentrate container 3 into the mixing container 11, the first filling step also including sending water to the mixing container to dilute the auxiliary liquid concentrate LC’; - The first recirculation step RS' of the first dilution liquid mixture DM' (the auxiliary liquid concentrate LC' with added water); - The second filling step FS" of filling the main liquid concentrate LC" arriving from the main concentrate container 2 into the mixing container 11 to form the dialysis mixture DiaM; - The second recirculation step RS" of the dialysis mixture DiaM to form the (homogeneous) dialysis fluid DF.

[0515] Now refer to Figures 1L to 1Q the sequence of

[0516] As Figure 1L shown, the MCDS is controlled by the control unit 24, which controls the valves among the plurality of valves to set the mixing container discharge path Y1 so as to allow the discharge of the mixing container 11, and controls the pump 8 to move any fluid inside the mixing container 11 through the outlet 13, at least a part of the main fluid line 4 on which the pump 8 is configured to operate, the discharge outlet line 30, and the discharge port 29. The mixing container discharge path Y1 ( Figure 1L ) includes the mixing container 11, the outlet 13, the mixing container outlet line 16 connecting the outlet 13 of the mixing container 11 to the first junction point j1 on the main fluid line 4, the first junction point j1, at least a part of the main fluid line 4 on which the pump 8 is activated from the first junction point j1 to the sixth junction point j6, the discharge outlet line 30 from the sixth junction point j6 to the discharge port 29, and the discharge port 29. In addition, the mixing container discharge path Y1 includes a mixing container outlet valve VMO configured to operate on the mixing container outlet line 16 and a discharge valve VDR configured to operate on the discharge outlet line 30. When the control unit (24) controls the plurality of valves to set the mixing container discharge path Y1, the mixing container outlet valve VMO and the discharge valve VDR are opened to allow fluid to flow from the mixing container 11 to the discharge port 29, while the other valves among the plurality of valves configured to operate on the fluid circuit 14 and different from the mixing container outlet valve VMO and the discharge valve VDR are closed. Preferably, the control unit 24 is configured to first set the mixing container discharge path Y1 before setting the concentrate recirculation paths Z6, X5.

[0517] In particular, when the medical fluid generation device 1 needs to start a new cycle for producing the dialysis fluid DF, the mixing container discharge path Y1 including the MCDS is set before all other paths. This is because at the start of each production cycle, the mixing container 11 must be completely discharged to perform at least one continuous cleaning procedure, the purpose of which is to configure the mixing container 11 to receive the auxiliary concentrate LC', water, and / or the dilution liquid mixture DM' so as to be mixed to produce the desired dialysis fluid DF.

[0518] During MCDS, the control unit 24 operates to effect the emptying of the mixing vessel 11. In the case of the flexible mixing vessel 11, the control unit 24 operates the pump 8 at a preset pumping rate and stops the pump 8 when a predetermined pressure has been reached in the mixing vessel discharge path Y1. In an illustrative embodiment for testing purposes, the preset pumping rate is set to approximately 300 ml / min and the predetermined pressure is equal to or less than -100 mmHg. Alternatively, in the case of using a rigid mixing vessel 11 with an open vent, the conductivity meter 25 can be used to detect when air enters the rigid mixing vessel. In this case, the conductivity drops sharply to near zero. Alternatively, MCDS starts with the vent closed and the headspace can be calculated using the gas laws. Knowing the total volume of the mixing vessel 11 allows the calculation of how much volume has been removed for emptying.

[0519] Go to Figure 1M That is, MCFS is part of the cleaning procedure of the mixing vessel 11. In particular, MCFS includes the control unit 24 driving a valve among the plurality of valves to set the mixing vessel filling path Y2 so as to at least flush the mixing vessel inlet line 15 and the mixing vessel 11. MCFS also includes the control unit 24 driving the pump 8 to move the fluid arriving from at least a part of the main fluid line 4 where the pump is activated to the mixing vessel inlet line 15 and the mixing vessel 11, in particular, from the inlet point 5 of the main fluid line 4 of the fluid circuit 14 to the mixing vessel inlet line 15 and the mixing vessel 11.

[0520] As Figure 1MAs highlighted, the mixing vessel filling path Y2 includes at least a portion (in particular, the entire main fluid line 4) of the main fluid line 4 of the fluid circuit 14 on which the pump 8 is activated, the sixth junction j6, the mixing vessel inlet line 15, and the mixing vessel 11. In addition, the mixing vessel filling path Y2 includes a water inlet valve VWI configured to operate on the main fluid line 4 and a mixing vessel inlet valve VMI configured to operate on the mixing inlet line 15. When the control unit 24 controls the plurality of valves to set the mixing vessel filling path Y2, at least the water inlet valve VWI and the mixing vessel inlet valve VMI remain open to allow fluid to flow from the fluid main line 4 to the mixing vessel 11. Other valves among the plurality of valves configured to operate on the fluid circuit 14 that can allow fluid to enter or leave the mixing vessel filling path Y2 are closed. In the case of using a rigid mixing vessel 11, the air valve 22 should also remain open. Preferably, all other valves among the plurality of valves configured to operate on the fluid circuit 14 that are different from the water inlet valve VWI, the mixing vessel inlet valve VMI, and the air valve 22 are closed. In the case of a flexible mixing vessel 11, a vent is not required, and thus, all other valves among the plurality of valves configured to operate on the fluid circuit 14 that are different from the water inlet valve VWI and the mixing vessel inlet valve VMI are closed.

[0521] During the mixing vessel filling step for flushing the MCFS, the control unit 24 operates the pump 8 at a preset pumping rate until a predetermined pumping volume is reached, and stops the pump 8 after the predetermined pumping volume has been reached. The predetermined pumping volume is sufficient to achieve proper flushing of the main fluid line (4) and the mixing vessel (11). In an illustrative embodiment for testing purposes, the preset pumping rate is about 330 ml / min, and the predetermined pumping volume is at least 100 ml.

[0522] As Figure 1L shown, the MCFS includes a mixing vessel emptying step MCES, in which the control unit 24 controls a valve among the plurality of valves to set a mixing vessel emptying path (which corresponds to Figure 1L the highlighted mixing vessel discharge path Y1) to at least flush the mixing vessel 11 and the mixing vessel outlet line 16. In particular, the mixing vessel emptying step MCES further includes the control unit 24 configuring the pump 8 activated on the main fluid line 4 to move the fluid arriving from the mixing vessel 11 to the discharge outlet line 30 and the discharge port 29. The mixing vessel emptying path is located downstream of the mixing vessel filling path Y2 and includes the mixing vessel outlet line 16, the first junction j1 on the main fluid line 4, at least a portion of the main fluid line 4, the sixth junction j6, the discharge outlet line 30, and the discharge port 29.

[0523] The mixed container evacuation path further includes a mixed container outlet valve VMO configured to operate on the mixed container outlet line 16 and a discharge valve VDR configured to operate on the discharge outlet line 30. When the control unit 24 controls the plurality of valves to set the mixed container evacuation path, at least the mixed container outlet valve VMO and the discharge valve VDR remain open to allow fluid to flow from the mixed container 11 to the discharge port 29. Other valves among the plurality of valves configured to operate on the fluid circuit 14 that can allow fluid to enter or leave the mixed container evacuation path remain closed.

[0524] After the MCFS, the mixed container evacuation step MCES is preferably controlled by the control unit 24. The mixed container evacuation step MCES allows the cleaning program to close its own cycle. Both the MCFS and the mixed container evacuation step MCES are preferably performed at the start of the dialysis fluid preparation cycle to clean the mixed inlet line 15, the mixed container 11, the mixed outlet line 16, and the main fluid line 4.

[0525] During the mixed container discharge step, the control unit 24 operates to evacuate the mixed container 11. In the case of the flexible mixed container 11, the control unit 24 operates the pump 8 at a preset pumping rate and stops the pump 8 when a predetermined pressure has been reached in the mixed container evacuation path. In an illustrative embodiment for testing purposes, the preset pumping rate is approximately 330 ml / min, and in particular the predetermined pressure detected on the mixed outlet line 16 is equal to or lower than -100 mmHg. Differently, in the case of using a rigid mixed container 11 with an open vent, a conductivity meter 25 can be used to detect when air enters the rigid mixed container. In this case, the conductivity drops sharply to near zero. Alternatively, the MCDS starts with the vent closed, and the headspace can be calculated using the gas laws. Knowing the total volume of the mixed container 11 allows calculation of how much volume has been removed for evacuation.

[0526] The perfusion step of the main fluid line PSMF includes the control unit 24 driving a valve among the plurality of valves to set a main fluid perfusion path (which corresponds to Figure 1B the highlighted main fluid path Z2 in) to flush the main fluid line 4. The PSMF further includes the control unit 24 driving the pump 8 to move the fluid arriving from the inlet point 5 at least to the discharge outlet line 30. In particular, the main fluid perfusion path includes at least a portion of the main fluid line 4 on which the pump 8 is configured to operate, in particular the entire main fluid line 4 of the fluid circuit 14. Preferably, the main fluid perfusion path is formed between the inlet point 5 and the outlet discharge line 30, specifically between the inlet point 5 and the discharge port 29.

[0527] More specifically, the main stream perfusion path includes a water inlet valve VWI configured to operate on the main stream pipeline 4 and a discharge valve VDR configured to operate on the outlet discharge pipeline 30. When the control unit 24 controls the plurality of valves to set the main stream perfusion path, at least the water inlet valve VWI and the discharge valve VDR remain open to allow fluid to flow from the fluid main pipeline 4 to the discharge outlet pipeline 30. The other valves among the plurality of valves configured to operate on the fluid circuit 14 remain closed.

[0528] During PSMF, the control unit 24 operates the pump 8 at a preset pumping rate until a predetermined period of time has elapsed. The pump 8 operates at least until the volume contained between the first joint j1 and the sixth joint j6 has been pumped, with the aim that any residual conductivity is low enough so as not to significantly affect the ingredient accuracy in subsequent steps. In an experimental embodiment for testing, the preset pumping rate is about 330 ml / min, and the predetermined period of time is 30 s. Additionally, during PSMF, the control unit 24 optionally operates the heater 23 on the main stream pipeline 4 to heat the fluid flowing through the main stream perfusion path to a value that allows for accurate conductivity measurement, for example, 37 °C.

[0529] During PSMF, the control unit 24 is configured to perform a main stream pipeline concentration test step MF-CTS to measure the concentration value of the fluid flowing through the main stream perfusion path. Optionally, the control unit 24 is configured to compare the concentration value measured in the fluid flowing through the main stream perfusion path with a concentration reference value to ensure that only water is present in the fluid path; in particular, the measured concentration value should not exceed 0.20 mS / cm, preferably not exceed 0.15 mS / cm.

[0530] PSMF can be performed right after the mixing container emptying step MCES and / or MCFS, or can correspond to the MFPS performed in relation to any dilution procedure associated with the DCDP and / or the liquid concentrate CM.

[0531] Moving on to Figure 1N , the FL' of the first diluted liquid mixture DM' includes the control unit 24 controlling the valves among the plurality of valves to set an auxiliary concentrate filling path F1 to fill the mixing container 11 with the auxiliary liquid concentrate LC', particularly according to a predetermined nominal volume. The FS' of the first diluted mixture DM' further includes the control unit 24 driving the pump 8 to move this liquid concentrate from the corresponding concentrate containers 2 and 3, particularly from the auxiliary concentrate container 3, to the mixing container 11.

[0532] More specifically, the auxiliary concentrate filling path F1 ( Figure 1N)It includes the second concentrate container inlet pipeline 37, the second concentrate mixing pipeline 41, the second junction point j2, at least a part of the main fluid pipeline 4 where the pump 8 is activated, the sixth junction point j6, the mixing container mixing pipeline 15, the inlet 12 of the mixing container 11, and the mixing container 11. In addition, the auxiliary concentrate filling path F1 includes a second concentrate mixing valve VAM configured to operate on the second concentrate mixing pipeline 41 and a mixing container inlet valve VMI configured to operate on the mixing inlet pipeline 15. When the control unit 24 controls the plurality of valves to set the auxiliary concentrate filling path F1, the second concentrate mixing valve VAM and the mixing container inlet valve VMI remain open to move the first dilution liquid mixture DM' arriving from the auxiliary concentrate container 3 to the mixing container 11. All other valves among the plurality of valves configured to operate on the fluid circuit 14 that can allow fluid to enter or leave the auxiliary concentrate filling path F1 remain closed.

[0533] Alternatively, the second auxiliary container inlet 46 and the auxiliary concentrate container outlet pipeline 40 until the third junction point j3 can be used as part of the auxiliary concentrate filling path F1 instead of the second concentrate container inlet pipeline 37, the second concentrate mixing pipeline 41, and the second junction point j2. In this case, the first port 9 of the auxiliary concentrate container 3 is directly connected to the second auxiliary container inlet 46 to prevent air from entering the pipeline.

[0534] During the FS' of the first dilution mixture DM', the control unit 24 operates the pump 8 at a preset pumping rate until a predetermined pumping volume is reached, and stops the pump 8 after the predetermined pumping volume has been reached. Optionally, the preset pumping rate is about 220 ml / min, and the predetermined pumping volume is equal to or higher than the predetermined nominal volume (from the formula) of the auxiliary liquid concentrate LC'. Additionally, during the FS' of the first dilution mixture DM', the control unit 24 operates the heater 23 on the main fluid pipeline 4 to heat the auxiliary liquid concentrate LC' flowing through the auxiliary concentrate filling path F1 to up to 37 °C. The first filling step FS' of the first dilution mixture DM' is preferably controlled by the control unit 24 after MCDS, after MCFS, after the mixing container emptying step MCES, and after PSMF.

[0535] As Fig.1OAs shown, after the first filling step FS' of the first dilution mixture DM', there is at least one water filling step FSW, which includes the control unit 24 driving the valves in the plurality of valves to set the water filling path W1, so as to at least partially fill the mixing container 11 with a predetermined volume of water. The water filling step FSW further includes the control unit 24 driving the pump 8 to make the water reaching from the inlet point 5 of the fluid circuit 14 flow into the mixing container 11. In particular, the water filling path W1 includes at least a part of the main fluid pipeline 4 (especially the part formed between the inlet point 5 of the fluid circuit 14 and the sixth junction point j6), the sixth junction point j6, the mixing container inlet pipeline 15, the inlet 12 of the mixing container 11 and the mixing container 11. More particularly, the water filling path W1 includes a water inlet valve VWI configured to operate on the main fluid pipeline 4 and a mixing container inlet valve VMI configured to operate on the mixing inlet pipeline 15. When the control unit 24 controls the plurality of valves to set the water filling path W1, the water inlet valve VWI and the mixing container inlet valve VMI remain open to allow the water reaching from the inlet point 5 of the fluid circuit 14 to flow into the mixing container 11. Other valves in the plurality of valves configured to operate on the fluid circuit 14 that can allow fluid to enter or leave the water filling path W1 can remain closed. Preferably, all other valves in the plurality of valves configured to operate on the fluid circuit 14 that are different from the water inlet valve VWI and the mixing container inlet valve VMI remain closed.

[0536] During the water filling step FSW, the control unit 24 operates the pump 8 at a preset pumping rate until a predetermined pumping volume (according to the formula) is reached, and stops the pump 8 after the predetermined pumping volume has been reached. Optionally, the predetermined pumping volume is maintained at a predetermined proportion of the tota...

Claims

1. A medical fluid generating device (1), comprising: - A fluid circuit (14), including a main fluid pipeline (4), the main fluid pipeline (4) having an inlet point (5) for receiving water; - A pump (8), configured to operate on the main fluid pipeline (4) to circulate fluid at least in the main fluid pipeline (4); - A plurality of valves, connected to the fluid circuit (14), configurable to define different fluid paths for the fluid inside the fluid circuit (14); - A support structure (42), accommodating the fluid circuit (14), the pump (8) and the plurality of valves, and including: · A first main container inlet (43, 44), which is a part of the fluid circuit (14) for fluid communication with the main concentrate container (2), the first main container inlet (43, 44) being in fluid communication with the main fluid pipeline (4); and · A first auxiliary container inlet (45, 46), which is a part of the fluid circuit (14) for fluid communication with the auxiliary concentrate container (3), the first auxiliary container inlet (45, 46) being in fluid communication with the main fluid pipeline (4); - A control unit (24), configured to operate the pump (8) and the plurality of valves; - A conductivity meter (25), associated with the control unit (24), configured to determine the conductivity of the fluid circulating in the medical fluid generating device; wherein the medical fluid generating device (1) further includes at least one of the following: · A mixing container inlet (47) and a mixing container outlet (48), the mixing container inlet (47) being a part of the fluid circuit (14), the mixing container outlet (48) being a part of the fluid circuit (14), the mixing container inlet (47) and the mixing container outlet (48) being for fluid communication with the inlet (12) of the mixing container (11) and the outlet (13) of the mixing container (11) respectively, the mixing container inlet (47) and the mixing container outlet (48) being in fluid communication with the main fluid pipeline (4) respectively; · A mixing container (11), having an inlet (12) in fluid communication with the main fluid pipeline (4) and an outlet (13) in fluid communication with the main fluid pipeline (4); wherein the fluid circuit (14) includes: · A medical fluid outlet (27) for providing medical fluid and a medical fluid outlet pipeline (28) for carrying the medical fluid to the medical fluid outlet (27), the medical fluid outlet pipeline (28) being configured to receive fluid from the main fluid pipeline (4), and the medical fluid outlet pipeline (28) being placed downstream of the pump (8); · A mixing container outlet pipeline (16), connecting the outlet (13) of the mixing container (11) to a mixing container outlet junction point (j1) on the main fluid pipeline (4), the mixing container outlet junction point (j1) being placed upstream of the pump (8); · A mixing vessel inlet pipeline (15) connecting a mixing vessel inlet junction (j6) on the main fluid pipeline (4) to the inlet (12) of the mixing vessel (11), the mixing vessel inlet junction (j6) being placed downstream of the pump (8); · A main concentrate container outlet pipeline (32, 36) connecting the first main container inlets (43, 44) to main concentrate container junctions (j4, j5) on the main fluid pipeline (4), the main concentrate container junctions (j4, j5) being placed upstream of the pump (8); · An auxiliary concentrate container outlet pipeline (40, 41) connecting the first auxiliary container inlets (45, 46) to auxiliary concentrate container junctions (j2, j3) on the main fluid pipeline (4), wherein the auxiliary concentrate container junctions (j2, j3) are placed upstream of the pump (8); wherein the conductivity meter (25) is downstream of the mixing vessel outlet junction (j1), the auxiliary concentrate container junctions (j2, j3) and the main concentrate container junctions (j4, j5) and upstream of the mixing vessel inlet junction (j6), and optionally, upstream of the pump (8), and is connected to the main fluid pipeline (4).

2. The medical fluid generating device according to claim 1, further comprising at least one of the following: - A main concentrate container (2) having at least one port (6, 7) in fluid communication with the main fluid pipeline (4), the port (6, 7) being in fluid communication with the first main container inlets (43, 44); and - An auxiliary concentrate container (3) having at least one port (9, 10) in fluid communication with the main fluid pipeline (4), the port (9, 10) being in fluid communication with the first auxiliary container inlets (45, 46).

3. The medical fluid generating device according to claim 2, wherein, The main concentrate container (2) includes a dry concentrate accommodated in the main concentrate container (2) in the form of powder or granules. In particular, the dry concentrate includes an osmotic agent such as hydrated glucose, and more particularly, the dry concentrate includes 100% hydrated glucose, and / or wherein the auxiliary concentrate container (3) includes a liquid concentrate, particularly an electrolyte and / or a buffer, wherein the device is used for preparing a dialysis fluid, particularly a PD fluid or an HD fluid.

4. The medical fluid generating device according to any one of the preceding claims, wherein, The plurality of valves includes one or more of the following: - A mixing vessel inlet valve (VMI) connected to the mixing vessel inlet pipeline (15); - A mixing vessel outlet valve (VMO) connected to the mixing vessel outlet pipeline (16); - A medical fluid outlet valve (VFO), connected to the medical fluid outlet line (28), in particular, the medical fluid outlet (27) is directly connected to the mixing container inlet line (15), optionally, the medical fluid outlet (27) is directly connected to the mixing container inlet line (15) upstream of the mixing container inlet valve (VMI) to receive the medical fluid flowing in a part of the mixing container inlet line (15); - A main concentrate container outlet valve (VGO), connected to the main concentrate container outlet line (32); - An auxiliary concentrate container outlet valve (VAO), connected to the auxiliary concentrate container outlet line (40); - A water inlet valve (VWI), placed on the main fluid line (4) upstream of the mixing container outlet junction (j1), the auxiliary concentrate container junctions (j2, j3), the main concentrate container junctions (j4, j5), and the mixing container inlet junction (j6).

5. The medical fluid generating device according to any one of the preceding claims, wherein, The fluid path at least includes a mixing recirculation path (R1), the mixing recirculation path (R1) includes the mixing container (11), the outlet (13) of the mixing container (11), the mixing container outlet line (16) and the mixing container outlet junction (j1), at least a part of the main fluid line (4) extending between the mixing container outlet junction (j1) and the mixing container inlet junction (j6), the mixing container inlet junction (j6) and the mixing container inlet line (15), the pump (8) is configured to operate in at least a part of the main fluid line (4), wherein the plurality of valves are configured to allow the fluid contained in the mixing container (11) to be recirculated through the mixing recirculation path (R1), wherein the control unit (24) is configured to: · Send liquid concentrate from the main concentrate container (2) or the auxiliary concentrate container (3) to the mixing container (11); · Send a certain amount of water to the mixing container (11); · Circulate a first liquid mixture (ML’) in the mixing recirculation path (R1), the first liquid mixture (ML’) being formed by the liquid concentrate with added water; and · Perform a main fluid line concentration test step (MF-CTS’), the main fluid line concentration test step (MF-CTS’) including detecting the conductivity of the first liquid mixture (ML’) flowing through the first mixing recirculation path (R1) by the conductivity meter (25); · Detect the time-resolved change of the conductivity, the time-resolved change of the conductivity of the fluid being related to the uniformity of the fluid recirculated in the mixing recirculation path (R1); · When the time-resolved change satisfies a change criterion, interrupt the circulation step of the first liquid mixture (ML’). Optionally, the change criterion includes comparing the time-resolved change in the conductivity, such as the conductivity change, with a predetermined threshold to determine proper mixing and homogenization of the first liquid mixture (ML’) in the mixing recycle path (R1).

6. The medical fluid generating device according to any one of the preceding claims, further comprising a second conductivity meter (26) associated with the control unit (24), the second conductivity meter (26) being configured to independently determine the conductivity of the fluid circulating in the medical fluid generating device, both the conductivity meter (25) and the second conductivity meter (26) sending independent signals to the control unit (24), the control unit being configured to determine the conductivity of the same fluid to obtain a backup metric, the second conductivity meter (26) being placed on the main fluid line (4), downstream of the mixing container outlet junction (j1), the auxiliary concentrate container junctions (j2, j3) and the main concentrate container junctions (j4, j5) and upstream of the mixing container inlet junction (j6), and optionally, upstream of the pump (8).

7. The medical fluid generating device according to any one of the preceding claims, further comprising a heater (23), the heater being controlled by the control unit (24) and being configured to heat the fluid circulating in the medical fluid generating device, the heater being placed on the main fluid line (4), optionally, upstream of the pump (8) and / or the conductivity meter (25).

8. The medical fluid generating device according to claim 7 of the preceding claims, further comprising a temperature sensor (T1) for sensing the temperature of the fluid in the main fluid line (4), in particular, the temperature sensor (T1) being placed downstream of the first junction (j1), the third junction (j3), the fifth junction (j5) and the heater (23), and upstream of the mixing container inlet junction (j6) and, optionally, the pump (8). Among them, The control unit (24) is configured to receive a temperature signal from the temperature sensor (T1) and is configured to control the heater (23) at least based on the received temperature sensor (T1).

9. The medical fluid generating device according to any one of the preceding claims, wherein, The control unit (24) is configured to control the pump (8) to pump the fluid inside the main pipeline (4) in the forward direction from the upstream of the pump towards the downstream of the pump. The inlet point (5) for receiving water, the mixing container outlet junction point (j1), the auxiliary concentrate container junction points (j2, j3), and the main concentrate container junction points (j4, j5) are placed upstream of the pump, and the mixing container inlet junction point (j6) is placed downstream of the pump. The control unit (24) is configured not to control the pump (8) to pump the fluid in the main pipeline (4) in the reverse direction from the mixing container inlet junction point (j6) towards any one of the inlet point (5) for receiving water, the mixing container outlet junction point (j1), the auxiliary concentrate container junction points (j2, j3), and the main concentrate container junction points (j4, j5) during the step for generating a medical fluid.

10. The medical fluid generating device according to any one of the preceding claims, wherein, The fluid circuit (14) further includes a discharge port (29) for discarding the fluid to a discharge section and a discharge outlet pipeline (30) for carrying the fluid from the main pipeline (4) to the discharge port (29). The plurality of valves further includes a discharge valve (VDR) connected to the discharge outlet pipeline (30).

11. The medical fluid generating device according to any one of the preceding claims, wherein, The fluid circuit (14) includes a main concentrate container inlet pipeline (31). The main concentrate container inlet pipeline (31) connects a junction point on the main fluid pipeline (4), particularly the mixing container inlet junction point (j6), to the first main container inlet (43, 44). The plurality of valves includes a main concentrate container inlet valve (VGI) connected to the main concentrate container inlet pipeline (31).

12. The medical fluid generating device according to any one of the preceding claims, wherein, The fluid circuit (14) includes an auxiliary concentrate container inlet pipeline (37). The auxiliary concentrate container inlet pipeline (37) connects a junction point on the main fluid pipeline (4), particularly the mixing container inlet junction point (j6), to the first auxiliary container inlet (45, 46). The plurality of valves includes an auxiliary concentrate container inlet valve (VAI) connected to the auxiliary concentrate container inlet pipeline (37).

13. The medical fluid generating device according to claim 12 preceding, when claim 12 depends on claim 9, wherein, The auxiliary concentrate container inlet pipeline (37) includes a common pipeline (38) having the main concentrate container inlet pipeline (31). The common pipeline (38) starts from the junction point, particularly the mixing container inlet junction point (j6), and reaches a branch (39) where the main concentrate container inlet pipeline (31) and the auxiliary concentrate container inlet pipeline (37) separate. In particular, the auxiliary concentrate container inlet valve (VAI) and the concentrate container inlet valve (VGI) are placed downstream of the branch (39).

14. The medical fluid generating device according to any one of the preceding claims further comprises a degassing chamber (33) configured to allow air removal, and the degassing chamber (33) is placed on the main concentrate container outlet line (32) between the first main container inlets (43, 44) and the main concentrate container outlet valve (VGO). The degassing chamber (33) includes a vent (34), and the vent (34) includes a vent line (35) to selectively discharge excess air. Optionally, it includes a gas valve (VGA) connected to the vent line (35) to selectively block the air passage through the vent line (35). In particular, the gas valve (VGA) is inserted on the vent line (35) between the main concentrate container (2) and the discharge section / air.

15. The medical fluid generation device according to any one of the preceding claims, wherein, The fluid circuit (14) includes a first concentrate mixing line (36) that joins the main concentrate container inlet junction (j4) on the main fluid line (4) to the first main container inlets (43, 44), in particular to the midpoint (31a) of the main concentrate container inlet line (31). The plurality of valves includes a first concentrate mixing valve (VGM) connected to the first concentrate mixing line (36). Wherein, the main concentrate container inlet junction (j4) is placed upstream of the pump (8).

16. The medical fluid generating device according to any one of the preceding claims, wherein, The fluid circuit (14) includes a second concentrate mixing line (41) that joins the secondary concentrate container inlet junction (j2) on the main fluid line (4) to the first secondary container inlets (45, 46), in particular to the midpoint (37a) of the secondary concentrate container inlet line (37). The plurality of valves includes a second concentrate mixing valve (VAM) connected to the second concentrate mixing line (41). Wherein, the secondary concentrate container inlet junction (j2) is placed upstream of the pump (8).

17. The medical fluid generation device according to any one of the preceding claims, wherein, The support structure (42) includes an inlet (5a) for water, and the inlet (5a) defines the inlet point (5) for receiving water.

18. The medical fluid generating device according to any one of the preceding claims further comprises a pressure sensor (P2) configured to sense the pressure of the fluid in the main fluid line (4) downstream of the pump (8), wherein, The pressure sensor (P2) is placed on the mixing container inlet line (15), optionally between the mixing container inlet junction (j6) and the mixing container inlet valve (VMI).

19. The medical fluid generating device according to any one of the preceding claims further comprises an auxiliary pressure sensor (P1) configured to sense the pressure occurring on the main fluid line (4) upstream of the pump (8), wherein, The auxiliary pressure sensor (P1) is placed on the mixing container outlet line (16), optionally between the mixing container outlet junction (j1) and the mixing container outlet valve (VMO).

20. The medical fluid generating device according to any one of the preceding claims further comprises one or more sterilization devices configured to operate on the fluid contained in the fluid circuit (14), wherein, The one or more sterilization devices are configured to operate on the main line (4) and / or the mixing container inlet line (15) and / or the mixing container outlet line (16), and / or on the fluid volume contained in the mixing container (11). For example, the one or more sterilization devices are UV sterilization devices.

21. The medical fluid generating device according to any one of the preceding claims, wherein, The mixing container (11) further includes a vent (19), the vent (19) including a vent line (20) and an air valve (22) placed along the vent line (20), the vent line (20) being for selectively discharging excess air, the air valve (22) being for selectively blocking the air passage through the vent line (20), optionally, the vent (19) including a filter (21) for filtering any air passing through the vent line (20), and the air valve (22) being inserted on the vent line (20) between the mixing chamber (11) and the filter (21).

22. The medical fluid generating device according to any one of the preceding claims, wherein, A first end of the medical fluid outlet line (28) is connected to the mixing container inlet line (15) and a second end of the medical fluid outlet line (28) is connected to the medical fluid outlet (27), wherein, optionally, the first end is connected upstream of the mixing container inlet valve (VMI) to receive medical fluid flowing in a portion of the mixing container inlet line (15) upstream of the mixing container inlet valve (VMI).

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