Devices for extracorporeal blood treatment

Abstract

An apparatus for extracorporeal blood treatment comprises a filtration unit, a blood circuit comprising a blood extraction line and a blood return line, and a fluid circuit. The fluid circuit comprises at least one or more water inlet pipes for receiving water, and a dialysis preparation assembly comprising one or more concentrate sources containing corresponding concentrate solutions and configured to prepare a mixed solution of dialysis fluid, wherein the water inlet pipe is configured to supply water to the dialysis preparation assembly for preparing the mixed solution of dialysis fluid. The fluid circuit further comprises an infusion preparation assembly comprising one or more concentrate sources containing corresponding concentrate solutions and configured to prepare a mixed solution of infusion fluid, wherein the water inlet pipe is configured to supply water to the infusion preparation assembly for preparing the mixed solution of infusion fluid.

Description

Technical Field

[0001] The present invention relates to an apparatus and a method for extracorporeal blood treatment, the apparatus being configured to prepare a mixed solution of a dialysis fluid to be provided to a dialyzer and a mixed solution of an infusion fluid to be infused into a patient's blood circuit. Both the dialysis fluid mixed solution and the infusion fluid mixed solution are prepared by mixing concentrated solutions of one or more substances with water, the one or more substances being provided from an inline source. In one embodiment, the present invention can be used to provide an acetate-free biofiltration process with constant or variable potassium management. Background Art

[0002] The kidneys perform many functions, including the removal of water, the excretion of catabolites (or metabolic waste products, such as urea and creatinine), the regulation of electrolyte concentrations in the blood (such as sodium, potassium, magnesium, calcium, bicarbonate, phosphate, and chloride), and the regulation of the body's acid / base balance, particularly through the removal of weak acids and the production of ammonium salts. In individuals who have lost kidney function, because these excretory and regulatory mechanisms no longer function, the body accumulates water and waste products of metabolism and exhibits an excess of electrolytes. To overcome renal dysfunction, blood treatment involving extracorporeal circulation within a blood circuit is conventionally performed through an exchanger with a semipermeable membrane (dialyzer), in which the patient's blood circulates on one side of the membrane and the dialysis fluid (containing the main electrolytes of the blood at concentrations close to those found in healthy human blood) circulates on the other side. The patient is connected to the extracorporeal blood circuit via an extraction (or arterial) line and a return (or venous) line, each having corresponding needles at its end. A pressure difference is generated between the two compartments of the dialyzer so that a portion of the plasma fluid enters the compartment containing the dialysis fluid by ultrafiltration of the membrane, and the two compartments are defined by a semipermeable membrane. The blood treatment involving waste products and electrolytes from metabolism is produced in the dialyzer by two mechanisms of molecular transport through the membrane between the blood and the dialysis fluid. By mixing pure water with a plurality of predetermined substances (e.g., electrolytes), a dialysis fluid is prepared upstream of the dialyzer to exchange with the patient's blood in the dialyzer. Water comes from an inlet port that receives purified and deionized water (e.g., by reverse osmosis) and is subsequently further filtered in the device, thereby providing a substantially endless source of water for the blood treatment device. The treatment device configured to provide hemofiltration or hemodiafiltration treatment also includes an infusion line that is connected to the blood circuit of a disposable dialyzer kit (dialysis disposable set) that can be used to infuse a replacement fluid into the patient's extracorporeal blood and / or infuse one or more specific substances to control blood parameters. For example, during dialysis treatment, a bicarbonate solution can be infused into the blood circuit to control the patient's blood acid-base balance: a bag containing a bicarbonate liquid solution is typically arranged to be connected to the blood circuit to allow controlled infusion. For example, US5578223 discloses a dialysis device in which fresh dialysis fluid, which does not include any bicarbonate solution, is transported toward the dialyzer (or alternatively, a post-infusion into the patient's extracorporeal blood). Another post-infusion line is arranged to be connected to an infusion solution contained in a corresponding bag. The infusion solution is a sodium bicarbonate solution. The device control unit is configured to automatically adjust the post-infusion flow rate based on the bicarbonate concentration in the infusion bag, the desired concentration of bicarbonate entering the patient, and the flow rate of the effluent. During extracorporeal blood treatment, the operator must manage the bag, i.e., provide a proper installation on the device scale, replace the empty bag with a new bag during treatment, and handle discharge and new bags.It is worth noting that the new bicarbonate bag is somewhat heavy (5 / 10 liter), which means that there are difficulties in installing it on the machine scale. In addition, due to the need for manual handling, the liquid volume is limited in order to reduce weight, which in turn means regular replacement operations. In order to at least partially solve some of the problems of the prior art, document US20010037968 discloses a dialysis device with online dialysis fluid preparation and also includes a post-infusion line from a container. The online preparation section receives water and provides a metered mixing of a first concentrate and a second concentrate with water. With the help of two conductivity meters, the control unit controls the appropriate conductivity of the dialysis fluid before directing the dialysis fluid to the dialyzer. The control unit is also programmed to control the mixing and infusion rate of the concentrate from the bag to achieve the target concentration of two different ionic species (i.e., sodium and potassium) entering the patient's blood. In accordance with the above, other prior art describes an online preparation section of a dialysis machine. For example, document US5344231 is directed to a device for preparing dialysis fluid starting from a pure water source. Water is drawn from the inlet of the main preparation line and piped to a powder cartridge. Once the cartridge is filled and the appropriate solution containing the solute is ready to be mixed for dialysis fluid preparation, the solution is injected into the main line leading to the inlet of the dialyzer. A recirculation loop is also provided, comprising a mixing vessel, a recirculation pump, a conductivity meter, and multiple cartridges for one or more powdered or liquid-based concentrates. These concentrates are electrolytes, including NaCl, KCl, CaCl, and MgCl. The recirculation pump determines the amount of water to be passed through one of the cartridges: when the desired conductivity is reached, the next cartridge can be connected sequentially. Water from the source also passes through another powder cartridge to prepare another mixed solution, which is then injected into the main line, where the concentration is checked using a conductivity meter and then leads to the dialyzer. US Pat. No. 6,793,827 describes a similar system configured to analyze potassium concentration during treatment; EP Pat. No. 278,100, US Pat. No. 5,460,446, and EP Pat. No. 401,130 illustrate other online preparation circuits. Document WO0074833A1 is directed to a centralized bicarbonate mixing system connected to multiple dialysis machines. The system includes a purified water source, a mixing tank, an ejector with a hopper for accommodating dry (powdered) bicarbonate material, a mixing pump, and a mixing pipe loop connecting the mixing pump, the ejector, and the mixing tank, so that water circulates in the mixing circuit and the dry bicarbonate material is drawn into the ejector and mixed with the water. A transfer pipe is provided so that the mixed bicarbonate solution can be transferred from the mixing pipe loop to a circulation tank. A circulation supply pipe is connected to the circulation tank so that the mixed bicarbonate solution can be pumped from the circulation tank to the dialysis machine. It is worth noting that the described circuit is arranged upstream relative to the dialysis machine, which is not described. Summary of the Invention

[0003] It is therefore an object of the present invention to at least partially address one or more disadvantages and / or limitations affecting previous solutions.

[0004] An object of embodiments of the present description is to provide an extracorporeal blood treatment apparatus that is capable of reducing the service operations provided by an operator during a blood treatment session, ie, reducing or avoiding the need for regular bag changes.

[0005] An object of embodiments of the present disclosure is to provide a dialysis device configured to improve treatment opportunities, thereby allowing control and / or analysis of several blood parameters (e.g., pH, ion concentration, etc.) independently of one another, while limiting operator intervention in the dialysis machine. In this regard, another object of embodiments of the present disclosure is to provide an extracorporeal blood treatment device capable of automatically preparing mixed solutions of different dialysis fluids and infusion fluids within the device itself.

[0006] Another object of the embodiments of the present specification is to provide an extracorporeal blood treatment apparatus capable of internally preparing a mixed solution online for infusion into a patient to control blood acid-base balance.

[0007] Another object of embodiments of the present specification is to provide an extracorporeal blood treatment apparatus that can reduce or avoid the need for regular replacement of bicarbonate liquid solution bags provided for blood acid-base balance control.

[0008] Another object of embodiments of the present specification is to provide an extracorporeal blood treatment apparatus that can increase safety during a blood treatment period, i.e., reduce the risk of blood contamination due to replacement of liquid solution bags during treatment or the risk of treatment being stopped due to an empty bag.

[0009] A first aspect is directed to a device (1) for extracorporeal blood treatment, comprising:

[0010] - a filter unit (2), the filter unit (2) having a main chamber (3) and a secondary chamber (4), the main chamber (3) and the secondary chamber (4) being separated by a semipermeable membrane (5);

[0011] - a blood circuit (17), the blood circuit (17) comprising at least:

[0012] a blood extraction line (6) extending between a first end connected to an inlet of the main chamber and a second end for connection to a patient (P); and

[0013] a blood return line (7) extending between a first end connected to the outlet of the main chamber (3) and a second end for connection to the patient (P);

[0014] - a fluid circuit (32), the fluid circuit (32) comprising at least:

[0015] One or more water inlet pipes (14a) for receiving water;

[0016] a dialysis preparation assembly (9), comprising one or more concentrate sources (27, 28) and configured to prepare a mixed solution of dialysis fluid, wherein the one or more concentrate sources (27, 28) contain corresponding concentrate solutions, and at least one of the one or more water inlet pipes (14a) is configured to provide water to the dialysis preparation assembly (9) for preparing the mixed solution of dialysis fluid,

[0017] an infusion preparation assembly (108) that is separate from and distinct from the dialysis preparation assembly (9), the infusion preparation assembly (108) comprising one or more concentrate sources (102) configured to prepare a mixed solution of infusion fluid, the one or more concentrate sources (102) containing corresponding concentrate solutions (103), at least one of the one or more water inlet tubes (14a) being configured to supply water to the infusion preparation assembly (108) for preparing the mixed solution of infusion fluid,

[0018] a shut-off element arranged at least on the fluid circuit (32) and operable on the fluid circuit (32) and configured to move at least between a closed position, in which the fluid passage is blocked, and an open position, in which the fluid passage is allowed;

[0019] a control unit (12) configured to control one or more of the shut-off elements between a closed position and an open position to determine a fluid flow configuration defined according to the fluid path, the fluid flow configuration comprising at least a main operating mode, wherein:

[0020] At least one of the one or more water inlet pipes (14a) is configured to provide water to the dialysis preparation component (9) for preparing the mixed solution of dialysis fluid, and the mixed solution of dialysis fluid can be supplied to the inlet of the secondary chamber (4) of the filtration unit (2), and

[0021] At least one of the one or more water inlet pipes (14a) is configured to provide water to the infusion preparation assembly (108) for preparing the mixed solution of infusion fluid, and the mixed solution of infusion fluid can be infused into the blood circuit (17) through the infusion access point (19), in particular into the blood return line (7) of the blood circuit (17). A second aspect relates to a method for extracorporeal blood treatment, comprising the following steps:

[0022] A device is provided, comprising:

[0023] - a filter unit (2), the filter unit (2) having a main chamber (3) and a secondary chamber (4), the main chamber (3) and the secondary chamber (4) being separated by a semipermeable membrane (5);

[0024] - a blood circuit (17), the blood circuit (17) comprising at least:

[0025] a blood extraction line (6) extending between a first end connected to an inlet of the main chamber and a second end for connection to a patient (P); and

[0026] a blood return line (7) extending between a first end connected to the outlet of the main chamber (3) and a second end for connection to said patient (P);

[0027] - a fluid circuit (32), the fluid circuit (32) comprising at least:

[0028] One or more water inlet pipes (14a) for receiving water;

[0029] a dialysis preparation assembly (9), comprising one or more concentrate sources (27, 28) and configured to prepare a mixed solution of dialysis fluid, wherein the one or more concentrate sources (27, 28) contain corresponding concentrate solutions, and at least one of the one or more water inlet pipes (14a) is configured to provide water to the dialysis preparation assembly (9) for preparing the mixed solution of dialysis fluid,

[0030] an infusion preparation assembly (108) that is separate from and distinct from the dialysis preparation assembly (9), the infusion preparation assembly (108) comprising one or more concentrate sources (102) containing respective concentrate solutions (103) and configured to prepare a mixed solution of infusion fluids, the one or more concentrate sources (102) being configured to provide water to the infusion preparation assembly (108) for preparing the mixed solution of infusion fluids,

[0031] a shut-off element arranged at least on the fluid circuit (32) and operable on the fluid circuit (32) and configured to move at least between a closed position, in which the fluid passage is blocked, and an open position, in which the fluid passage is allowed;

[0032] By controlling the shut-off element between a closed position and an open position, a fluid flow configuration defined according to a fluid path is determined, the fluid flow configuration including at least a main operating mode, wherein:

[0033] At least one of the one or more water inlet pipes (14a) is configured to provide water to the dialysis preparation component (9) to prepare the mixed solution of dialysis fluid, and the mixed solution of dialysis fluid can be supplied to the inlet of the filtration unit (2), and

[0034] At least one of the one or more water inlet tubes (14a) is configured to provide water to the infusion preparation component (108) to prepare the mixed solution of infusion fluid, and the mixed solution of infusion fluid can be infused into the blood circuit (17) through the infusion access, in particular into the blood return line (7) of the blood circuit (17).

[0035] The method comprises the following steps in the main operation mode:

[0036] Feeding water to the dialysis preparation assembly (9);

[0037] preparing the mixed solution of dialysis fluid;

[0038] supplying a mixed solution of dialysis fluid to an inlet of the filtration unit (2);

[0039] Feeding water to the infusion preparation assembly (108);

[0040] preparing the mixed solution of infusion fluid;

[0041] The mixed solution of the infusion fluid is infused into the blood circuit (17), in particular into the blood return line (7) of the blood circuit (17), via the infusion access.

[0042] It is particularly noted that according to any one of the first and second aspects, the step of supplying a mixed solution of dialysis fluid and the step of supplying a mixed solution of infusion fluid are simultaneous. In the main operating mode, the dialysis fluid and the infusion fluid are not mixed and are delivered independently.

[0043] In a third aspect according to any one of the preceding aspects, in the main operating mode:

[0044] - the outlet of the dialysis preparation assembly (9) is fluidly connected to the inlet of the secondary chamber (4) of the filtration unit (2), and / or

[0045] The outlet of the infusion preparation set (108) is fluidly connected to the blood circuit (17), in particular to the blood return line (7) of the blood circuit (17).

[0046] In a fourth aspect according to any of the preceding aspects, the device comprises a supply line (8) extending between an outlet of the dialysis preparation assembly (9) and an inlet of the secondary chamber (4) of the filtration unit (2).

[0047] In a fifth aspect according to any of the preceding aspects, the device comprises an infusion line (109) extending between an outlet of the infusion preparation set (108) and an infusion access point (19) of the blood circuit (17), in particular between the outlet of the infusion preparation set (108) and an access point (19) arranged on a blood return line (7) of the blood circuit (17).

[0048] In a sixth aspect according to any of the preceding aspects, said infusion access point (19) of the blood circuit (17) is at an air separator configured to remove gas from the fluid and / or blood before the fluid and / or blood is infused into the patient.

[0049] In a seventh aspect according to any one of the preceding aspects, the one or more water inlet tubes (14a) are configured to supply water to both the dialysis preparation assembly (9) and the infusion preparation assembly (108).

[0050] In an eighth aspect according to any of the preceding aspects, in the main operating mode, one or more water inlet pipes (14a) are configured to supply water independently and directly to both the dialysis preparation component (9) and the infusion preparation component (108) through different pipe sections.

[0051] In a ninth aspect according to any one of the preceding aspects, the control unit (12) is configured to control the dialysis preparation component (9) and the infusion preparation component (108) to prepare a mixed solution of dialysis fluid and a mixed solution of infusion fluid, respectively, such that the mixed solution of dialysis fluid and the mixed solution of infusion fluid have different compositions, in particular, the difference between the dialysis fluid and the infusion fluid is based on:

[0052] o the nature of the solute or solutes; and / or

[0053] oThe concentration of one or more solutes.

[0054] In a tenth aspect according to any one of the preceding aspects, in the main operating mode:

[0055] - supplying a mixed solution of dialysis fluid to the inlet of the secondary chamber (4) of the filtration unit (2) while the mixed solution of infusion fluid is infused into the blood circuit (17), in particular wherein the infusion fluid is not conveyed to the secondary chamber (4) of the filtration unit (2) and in particular the dialysis fluid is not infused into the blood circuit (17).

[0056] In an eleventh aspect according to any of the preceding aspects, in the primary operating mode, the dialysis fluid and the infusion fluid are conveyed to the secondary chamber (4) of the filtration unit (2) and the blood circuit (17), respectively, without being mixed together.

[0057] In a twelfth aspect according to any one of the preceding aspects, the fluid circuit (32) comprises a first preparation line (9a) and a second preparation line (108a), the first preparation line (9a) being different from the second preparation line (108a).

[0058] In a thirteenth aspect according to the preceding aspect:

[0059] - the dialysis preparation assembly (9) comprises a first preparation line (9a), and

[0060] - the infusion preparation assembly (108) comprises a second preparation line (108a);

[0061] Both the first preparation line (9a) and the second preparation line (108a) are individually connected to a water inlet pipe (14a), and in particular, the water inlet pipe is arranged upstream relative to both the first preparation line (9a) and the second preparation line (108a).

[0062] In a fourteenth aspect according to either of the two previous aspects, at least in the main operating mode, the first preparation line (9a) and the second preparation line (108a) together define fluidically independent branches of the fluid circuit (32).

[0063] In a fifteenth aspect according to any of the preceding aspects, in the main operating mode, the mixed solution of the infusion fluid does not mix with the mixed solution of the dialysis fluid at least within the fluid circuit (32).

[0064] In a sixteenth aspect according to any of the preceding aspects, the fluid flow configuration further comprises a second mode of operation, wherein:

[0065] - the mixed solution of the infusion fluid and the mixed solution of the dialysis fluid are mixed so as to define an auxiliary mixed solution of the dialysis fluid, in particular an auxiliary mixed solution of the dialysis fluid flowing in the supply line (8);

[0066] and optionally wherein:

[0067] - an auxiliary mixed solution of the dialysis fluid may be supplied to the inlet of the secondary chamber (4) of the filtration unit (2); and / or

[0068] - an auxiliary mixed solution of the dialysis fluid can be infused into the blood circuit (17),

[0069] In particular, the control unit is configured to define a second operating mode of the fluid flow configuration by controlling the shut-off element to fluidically connect the infusion preparation component (108) to the dialysis preparation component (9) to obtain an auxiliary mixed solution of the dialysis fluid, in particular, the control unit controls the shut-off element to fluidically connect the infusion preparation component (108) to the dialysis preparation component (9) in series.

[0070] In a seventeenth aspect according to the preceding aspects, in the second operating mode, the dialysis preparation assembly (9) is fluidically connected in series with respect to the infusion preparation assembly (108), in particular fluidically connected in series upstream or downstream with respect to the infusion preparation assembly (108).

[0071] In an eighteenth aspect according to any one of the two previous aspects, in the second operating mode, the first preparation line (9a) is fluidically connected in series with the second preparation line (108a), in particular fluidically connected in series upstream or downstream with respect to the second preparation line (108a).

[0072] In a nineteenth aspect according to any one of the three previous aspects, in the second operating mode, the dialysis preparation assembly (9) is fluidly connected downstream to the infusion preparation assembly (108).

[0073] In a twentieth aspect according to any of the preceding aspects, the fluid flow configuration further comprises a third mode of operation, wherein:

[0074] - the mixed solution of infusion fluid and the mixed solution of dialysis fluid are mixed, thereby defining an auxiliary mixed solution of dialysis fluid flowing in the supply line (8);

[0075] - an auxiliary mixed solution of the dialysis fluid can be supplied to the inlet of the secondary chamber (4) of the filtration unit (2);

[0076] - Optionally, an auxiliary mixed solution of the dialysis fluid can be infused into the blood circuit (17).

[0077] In a twenty-first aspect according to the preceding aspects, in said third operating mode, the dialysis preparation assembly (9) is fluidically connected in parallel with respect to the infusion preparation assembly (108).

[0078] In a twenty-second aspect according to any one of the two preceding aspects, in the third operating mode, the first preparation line (9a) is fluidically connected in parallel with respect to the second preparation line (108a).

[0079] In a twenty-third aspect according to any one of the three previous aspects, in a third mode of operation, the outlet of the first preparation line (9a) is fluidly connected to the outlet of the second preparation line (108a), which feeds into the supply line (8).

[0080] In a twenty-fourth aspect according to any of the preceding aspects, the one or more concentrate sources (27, 28) of the dialysis preparation assembly (9) comprise at least one concentrate from the group consisting of sodium chloride, calcium chloride, magnesium chloride, potassium chloride.

[0081] In a twenty-fifth aspect according to any of the preceding aspects, at least one concentrated solution (103) contained in one or more concentrated sources (102) of the infusion preparation component (108) comprises a buffer substance, in particular at least one from the group between bicarbonate, citrate, lactate and acetate, in particular bicarbonate powder.

[0082] In a twenty-sixth aspect according to any of the preceding aspects, in the main operating mode, at least one concentrated solution (103) contained in the one or more concentrate sources (102) of the infusion preparation assembly (108) comprises a bicarbonate, in particular sodium bicarbonate, such as dry sodium bicarbonate.

[0083] In a twenty-seventh aspect according to any of the preceding aspects, in the main operating mode, at least one concentrated solution (103) contained in the one or more concentrate sources (102) of the infusion preparation assembly (108) comprises sodium, in particular dry sodium in the form of dry sodium bicarbonate or dry sodium chloride.

[0084] In a twenty-eighth aspect according to any of the preceding aspects, in the primary operating mode, one of the one or more concentrate sources (27, 28) of the dialysis preparation assembly (9) comprises concentrated electrolytes including sodium, calcium and potassium and optionally magnesium.

[0085] In a twenty-ninth aspect according to any of the preceding aspects, in the primary operating mode, one of the one or more concentrate sources (27, 28) of the dialysis preparation assembly (9) comprises glucose and optionally citrate.

[0086] In a thirtieth aspect according to any of the preceding aspects, in the primary operating mode, another of the one or more concentrate sources (27, 28) of the dialysis preparation assembly (9) comprises concentrated electrolytes including sodium and calcium and optionally magnesium.

[0087] In a thirty-first aspect according to any of the preceding aspects, the potassium concentration in one of the one or more concentrated sources (27, 28) is different from the potassium concentration (27, 28) in another of the one or more concentrated sources (27, 28), in particular the other of the one or more concentrated sources (27, 28) that does not contain potassium.

[0088] In a 32nd aspect according to any of the preceding aspects, the concentration of electrolytes other than potassium is equal in one of the one or more concentrated sources (27, 28) and in the other of the one or more concentrated sources (27, 28).

[0089] In a thirty-third aspect according to any of the preceding aspects, in the primary operating mode, another of the one or more concentrate sources (27, 28) of the dialysis preparation assembly (9) comprises glucose and optionally citrate.

[0090] In a thirty-fourth aspect according to any one of the preceding aspects sixteen to thirty-three, in the second operating mode, at least one concentrated solution (103) contained in the one or more concentrate sources (102) of the infusion preparation assembly (108) comprises sodium, in particular dry sodium in the form of dry sodium bicarbonate or dry sodium chloride.

[0091] In a thirty-fifth aspect according to any one of the preceding aspects sixteen to thirty-four, in the second operating mode, at least one concentrated solution (103) contained in the one or more concentrate sources (102) of the infusion preparation component (108) comprises a bicarbonate, in particular sodium bicarbonate, such as dry sodium bicarbonate.

[0092] In a thirty-sixth aspect according to any of the preceding aspects sixteen to thirty-five, in the second operating mode, one of the one or more concentrate sources (27, 28) of the dialysis preparation assembly (9) comprises concentrated electrolytes including calcium and potassium and optionally magnesium.

[0093] In a thirty-seventh aspect according to any of the preceding aspects sixteen to thirty-six, in the second operating mode, one of the one or more concentrate sources (27, 28) of the dialysis preparation assembly (9) comprises glucose and optionally citrate.

[0094] In a 38th aspect according to any of the preceding aspects, one of the one or more concentrate sources (27, 28) of the dialysis preparation assembly (9) comprises the following components:

[0095] o sodium,

[0096] oPotassium,

[0097] oCalcium,

[0098] o Magnesium,

[0099] o Citrate,

[0100] oGlucose

[0101] In a thirty-ninth aspect according to the preceding aspects, when the component is diluted in the fluid flowing in the first preparation line, the component is within the following concentration range in millimoles / liter (mmol / l):

[0102] sodium 0 or 120-170 mmol / l Potassium, 0-9mmol / l calcium, 1-3mmol / l magnesium, 0.2-0.6mmol / l Citrate, 0-2mmol / l glucose 0-10mmol / l

[0103] Particularly where sodium is optional, but when present, the sodium is in the range between 120-170 mmol / l.

[0104] In a 40th aspect according to any one of the preceding aspects, when the component is diluted in the fluid flowing in the first preparation line (9a), the component is within the following concentration range in mmol / l:

[0105]

[0106]

[0107] Particularly where sodium is optional, but when present, the sodium is in the range between 130-160 mmol / l.

[0108] In a 41st aspect according to any of the preceding aspects, the at least one concentrated solution (103) contained in the one or more concentrated sources (102) of the infusion preparation assembly (108) comprises the following components:

[0109] o sodium,

[0110] oBicarbonate

[0111] Wherein, when the component is diluted in the fluid flowing in the second preparation pipeline (108a), the component is within the following concentration range in mmol / l:

[0112] sodium, 120-170mmol / l bicarbonate 20-40mmol / l

[0113] In a 42nd aspect according to any one of the preceding aspects, when the component is diluted in the fluid flowing in the second preparation line (108a), the component is within the following concentration range in mmol / l:

[0114] sodium, 130-160mmol / l bicarbonate 24-38mmol / l

[0115] In a 43rd aspect according to any of the preceding aspects, the one or more water inlet pipes (14a) are configured to receive water from a purification system arranged upstream, the purification system being configured to provide purified water, in particular distilled water, to the water inlet pipes.

[0116] In a 44th aspect according to any of the preceding aspects, the device comprises a conductivity sensor (35) arranged in the dialysis preparation assembly (9), in particular on the first preparation line (9a) downstream with respect to the one or more concentrate sources (27, 28), and configured to provide a signal representative of the conductivity of the mixed solution of the dialysis fluid and, optionally, of the conductivity of an auxiliary mixed solution of the dialysis fluid,

[0117] The control unit (12) is configured to receive the conductivity signal.

[0118] In a 45th aspect according to the preceding aspect, the control unit (12) is configured to receive a signal representing conductivity, to determine an actual conductivity and to compare the actual conductivity with a target conductivity.

[0119] In a 46th aspect according to the preceding aspects, the control unit is configured to drive the dialysis preparation component (9) to reduce a difference between the actual conductivity and the target conductivity.

[0120] In a 47th aspect according to any of the previous aspects, the device comprises a flow meter (41) arranged on the supply line (8) and configured to provide a signal representative of the flow rate of the mixed solution of the dialysis fluid, optionally of the flow rate of an auxiliary mixed solution of the dialysis fluid,

[0121] The control unit (12) is configured to receive the flow signal.

[0122] In a 48th aspect according to any of the preceding aspects, the device comprises a dialysis fluid pump (25) arranged on the supply line (8) and configured to determine the flow rate of the mixed solution of dialysis fluid and, optionally, the flow rate of an auxiliary mixed solution of dialysis fluid.

[0123] In a 49th aspect according to the preceding aspects, the control unit (12) is configured to control the dialysis fluid pump (25), in particular, the control unit is configured to control the start, stop and speed of the fluid pump (25).

[0124] In a fiftieth aspect according to any of the preceding aspects, the apparatus comprises a conductivity sensor (104) arranged in the infusion preparation assembly (108), in particular on a second preparation line (108a) downstream relative to the one or more concentrate sources (102) of the infusion preparation assembly (108), and configured to provide a signal representing the conductivity of the mixed solution of the infusion fluid,

[0125] The control unit (12) is configured to receive the conductivity signal.

[0126] In a fifty-first aspect according to the preceding aspect, the control unit (12) is configured to receive a signal representing conductivity to determine an actual conductivity and to compare the actual conductivity with a target conductivity.

[0127] In a fifty-second aspect according to any one of the preceding aspects, the control unit is configured to drive the infusion preparation assembly (108) to reduce a difference between the actual conductivity and the target conductivity.

[0128] In a fifty-third aspect according to any one of the preceding aspects, the device comprises a flow meter (105) arranged in the infusion preparation assembly (108), in particular on the second preparation line (108a), and configured to provide a signal representing the flow rate of the mixed solution of the infusion fluid,

[0129] The control unit (12) is configured to receive the flow signal.

[0130] In a fifty-fourth aspect according to any one of the preceding aspects, the apparatus comprises an infusion pump (106, 111) arranged on the second preparation line (108a) and configured to determine a flow rate of the mixed solution of the infusion fluid,

[0131] The control unit (12) is configured to control the infusion pump (106, 111), and in particular, the control unit is configured to control the start, stop and speed of the infusion pump (106, 111).

[0132] In a fifty-fifth aspect according to any of the preceding aspects, the fluid circuit (32) comprises at least one infusion ultrafilter (107), in particular a first infusion ultrafilter (107a) and a second infusion ultrafilter (107b) arranged in series, the at least one infusion ultrafilter (107) being located on the infusion line (109) and configured to provide filtration of a mixed solution of the infusion fluid.

[0133] In a fifty-sixth aspect according to any of the preceding aspects, the concentrated source (102) of the infusion preparation assembly (108) comprises a reservoir containing a concentrated substance (103) comprising bicarbonate, in particular bicarbonate powder.

[0134] In a fifty-seventh aspect according to any one of the preceding aspects, the shut-off element comprises at least an inlet valve (34) arranged on the first preparation line (9a), said inlet valve being interposed between the water inlet pipe (14a) and one or more concentrate sources (27, 28) of the dialysis preparation assembly (9).

[0135] In a fifty-eighth aspect according to any one of the preceding aspects, the shut-off element comprises at least an inlet valve (100a) arranged on a second preparation line (108a), the inlet valve being interposed between the water inlet pipe (14a) and one or more concentrate sources (102) of the infusion preparation assembly (108).

[0136] In a fifty-ninth aspect according to any one of the preceding aspects, the fluid circuit (32) comprises a bridge line (110) interposed in the fluid connection between the infusion line (109) and the supply line (108).

[0137] In a sixtieth aspect according to the preceding aspect, the shut-off element comprises a bridge valve (110a) arranged on the bridge line (110) to allow or block fluid flow between the infusion line (109) and the supply line (108).

[0138] In a sixty-first aspect according to any one of the preceding aspects, the shut-off element comprises an infusion valve (109a) arranged on the infusion line (109) to allow or prevent the flow of the infusion fluid towards the access point (19).

[0139] In a sixty-second aspect according to any one of the preceding aspects, in the main operating mode, the inlet valves (34, 100a) of the first preparation line and the second preparation line (9a, 108a) are in an open position.

[0140] In a sixty-third aspect according to any one of the preceding aspects, in the main operating mode, the bridge valve (110a) is in a closed position.

[0141] In a sixty-fourth aspect according to any of the preceding aspects, in the primary operating mode, the dialysis fluid pump (25) determines the flow of dialysis fluid towards the secondary chamber (4) of the filtration unit (2).

[0142] In a sixty-fifth aspect according to any of the preceding aspects, in a primary operating mode, the infusion pump (106) of the infusion line (109) determines the flow of infusion fluid towards the access point (19) of the blood circuit (17) or directly in the patient's vascular access.

[0143] In a sixty-sixth aspect according to any one of the previous aspects sixteen to sixty-five, in the second operating mode, the inlet valve (34) of the first preparation line (9a) is in a closed position.

[0144] In a sixty-seventh aspect according to any one of the previous aspects sixteen to sixty-six, in the second operating mode, the inlet valve (100a) of the second preparation line (108a) is in an open position.

[0145] In a sixty-eighth aspect according to any one of the previous aspects sixteen to sixty-seven, in the second operating mode, the bridge valve (110a) is in an open position.

[0146] In a sixty-ninth aspect according to any one of the previous aspects sixteen to sixty-eight, in the second operating mode, the dialysis fluid pump (25) determines the flow of dialysis fluid towards the secondary chamber (4) of the filtration unit (2).

[0147] In a seventieth aspect according to any one of the preceding aspects sixteen to sixty-nine, in the second operating mode, the infusion pump (106) of the infusion line (109) is not activated.

[0148] In a seventy-first aspect according to any of the preceding aspects, the apparatus comprises a graphical user interface (22) operably connected to the control unit (12) and configured to receive one or more inputs from a user to select at least one between the primary operating mode and the second operating mode (and optionally the third operating mode).

[0149] In a seventy-second aspect according to any of the preceding aspects, at least one of the concentrate sources (27, 28) of the dialysis preparation assembly (9) comprises a concentrated solution of potassium,

[0150] In a seventy-third aspect according to the preceding aspects, the dialysis fluid preparation assembly (9) comprises a delivery line (37) and a concentrate pump (30) arranged on the delivery line (37), the delivery line (37) fluidically connecting the concentrate source (28) comprising potassium to a first preparation line (9a), wherein the concentrate pump (30) of the dialysis fluid preparation assembly (9) is configured to deliver a predetermined flow rate of a concentrated solution of potassium to the first preparation line (9a).

[0151] In a seventy-fourth aspect according to any one of the preceding aspects, the other of the concentrate sources (27, 28) of the dialysis preparation assembly (9) comprises a concentrate solution without potassium or a concentrate solution having a potassium concentration that is different from the potassium concentration in the concentrate source (28), and the dialysis fluid preparation assembly (9) comprises a delivery line (36) and a concentrate pump (29) arranged on the delivery line (36), the delivery line (36) fluidically connecting the concentrate source (27) to the first preparation line (9a).

[0152] In a seventy-fifth aspect according to the preceding aspects, the concentrate pump (29) of the dialysis fluid preparation assembly (9) is configured to deliver a predetermined flow of concentrate solution into the first preparation line (9a), and the control unit (12) is configured to drive the concentrate pump (29, 30) to deliver a constant amount or a profiled amount of potassium to obtain a set concentration value of potassium in the dialysis fluid or a set concentration profile of potassium in the dialysis fluid over time.

[0153] In a seventy-sixth aspect according to any one of the preceding aspects, the control unit (12) is configured to command the dialysis preparation component (9) to obtain a predetermined potassium concentration value in the mixed solution of the dialysis fluid.

[0154] In a 77th aspect according to any one of the preceding aspects, the potassium concentration value is constant during the blood treatment or is variable according to a predetermined potassium profiling curve.

[0155] In a seventy-eighth aspect according to any of the preceding aspects, the control unit (12) is configured to change the potassium concentration in the mixed solution of the dialysis fluid during blood treatment according to a potassium profile curve, in particular, the profile curve presents a decreasing potassium concentration over time.

[0156] In a seventy-ninth aspect according to the preceding aspects, the potassium profile is according to the following formula:

[0157] Among them, T delay <t<T dialysis

[0158] in:

[0159] K(t) is the actual value of potassium concentration in the mixed solution of the dialysis fluid;

[0160] K ini is the initial value of potassium concentration in the mixed solution of the dialysis fluid;

[0161] K F is the final value of potassium concentration in the mixed solution of dialysis fluid;

[0162] T delay is the initial time delay in the initiation of potassium delivery;

[0163] T dialysis is the length of blood processing;

[0164] t is the current processing time.

[0165] In an eightieth aspect according to anyone of the preceding aspects, in the main operating mode the conductivity value of the mixed solution of the dialysis fluid does not directly affect the conductivity value of the mixed solution of the infusion fluid.

[0166] In an eighty-first aspect according to any of the preceding aspects, the device comprises a blood pump (21) operable on the blood circuit (17), in particular on a blood extraction line (6) of the blood circuit (17).

[0167] In an 82nd aspect according to any of the preceding aspects, the fluid circuit (32) comprises one water inlet pipe (14a) for receiving water, said water inlet pipe (14a) branching into a water line (100) for feeding water directly to the infusion fluid preparation assembly (108), and a water branch (113) for feeding water directly to the dialysis fluid preparation assembly (9).

[0168] In an eighty-third aspect according to the preceding aspects, the shut-off element comprises one or more valves (100a, 34) to allow or prevent water from flowing in the water line (100) and / or the water branch (113), in particular, the shut-off element comprises an inlet valve (100a) and an inlet valve (34), wherein the inlet valve (100a) is upstream of the infusion fluid preparation component (108) to allow or prevent fluid from flowing in the water line (100), and the inlet valve (34) is upstream of the dialysis fluid preparation component (9) to allow or prevent fluid from flowing in the water branch (113).

[0169] In an 84 aspect according to anyone of the preceding aspects, in the main operating mode, the control unit (12) drives the one or more valves (100a, 34) to allow water to flow through the water branch (113) towards the dialysis fluid preparation assembly (9) and through the water line (100) towards the infusion preparation assembly (108).

[0170] In an 85th aspect according to any of the preceding aspects, the fluid circuit (32) comprises a bridge line (110) fluidically connecting an outlet of the infusion fluid preparation assembly (108) with an inlet of the dialysis fluid preparation assembly (9), wherein the shut-off element comprises one or more valves (110a) to allow or prevent water from flowing in the bridge line (110).

[0171] In an 86th aspect according to any of the preceding aspects, in the main operating mode, the control unit (12) drives one or more valves (110a) to prevent fluid flow through the bridge line (110) between the outlet of the infusion preparation assembly (108) and the inlet of the dialysis fluid preparation assembly (9).

[0172] In an 87th aspect according to any of the preceding aspects, the fluid circuit (32) comprises an infusion line (109) connected to an outlet of the infusion preparation assembly (108) for conveying the infusion fluid to the blood circuit (17).

[0173] In an 88th aspect according to any of the preceding aspects, the fluid circuit (32) comprises a supply line (8) connected to an outlet of the dialysis preparation assembly (9) carrying the infusion fluid to the filtration unit (2).

[0174] In an 89th aspect according to any one of the preceding aspects, the fluid circuit (32) comprises a connecting line (114) fluidly connecting the infusion line (109) and the supply line (8),

[0175] The shut-off element includes one or more valves (114a, 114b) to allow or prevent fluid flow in the connecting line (114).

[0176] In aspect 89a according to the preceding aspect, the connecting line (114) is connected to the infusion line (109) at a branch point interposed between the infusion pump (106) and the infusion ultrafilter (107).

[0177] In the eighty-ninth aspect b according to the two preceding aspects, the connecting line ( 114 ) is connected to the supply line ( 8 ) at a branch point placed downstream of the dialysis fluid preparation assembly ( 9 ).

[0178] In the ninetieth aspect according to the three previous aspects, in the main operating mode, the control unit (12) drives one or more valves (114a, 114b) to prevent fluid flow through the connecting line (114) between the infusion line (109) and the supply line (8).

[0179] In a ninety-first aspect according to any one of the preceding aspects, the fluid circuit (32) comprises an infusion line (109) connected to an outlet of an infusion preparation assembly (108) for conveying an infusion fluid to the blood circuit (17), the infusion line comprising an online port (115) and a tube portion connecting the outlet of the infusion preparation assembly (108) to the online port (115).

[0180] In a ninety-second aspect according to any one of the preceding aspects, the tube portion connecting the outlet of the infusion preparation component (108) to the online port (115) includes an infusion pump (106), in particular, the infusion pump (106) is placed between the outlet of the infusion preparation component (108) and a connecting line (114) which fluidly connects the tube portion with the outlet of the dialysis preparation component (9).

[0181] In a ninety-third aspect according to any of the preceding aspects, the tubing section connecting the outlet of the infusion preparation assembly (108) to the online port (115) comprises at least one infusion ultrafilter (107), in particular the infusion ultrafilter (107) is placed between the connecting line (114) fluidly connecting the tubing section with the outlet of the dialysis preparation assembly (9) and the online port (115).

[0182] In a ninety-fourth aspect according to any one of the preceding aspects, the online port (115) is an inlet placed on an external part of the cabinet of the device, the online port (115) being configured for connecting a disposable tube that guides fluid to the blood circuit (17).

[0183] In a ninety-fifth aspect according to any of the preceding aspects, the fluid circuit (32) comprises a junction tube (116) fluidically connecting the supply line (8) to the infusion line (109), in particular connecting the supply line (8) downstream of an infusion pump (106) placed on the infusion line (109), and optionally connecting the supply line (8) downstream of an infusion ultrafilter (107).

[0184] In a ninety-sixth aspect according to the preceding aspect, the shut-off element comprises one or more valves (116a) to allow or prevent fluid from flowing in the junction tube (116).

[0185] In a ninety-seventh aspect according to any one of the two preceding aspects, in the main operating mode, the control unit (12) drives one or more valves (116a) to prevent fluid flow between the infusion line (109) and the supply line (8) through the coupling tube (116).

[0186] In a ninety-eighth aspect according to any one of the three previous aspects, a junction tube (116) connects the supply line (8) to the inline port (115) of the infusion line (109).

[0187] In a ninety-ninth aspect according to any of the preceding aspects, the fluid circuit (32) comprises a water inlet pipe (14a) for receiving water, said water inlet pipe (14a) branching into a water line (100) to feed water directly to the infusion fluid preparation component (108), and branching into a water branch (113) to feed water directly to the dialysis fluid preparation component (9), wherein the fluid circuit (32) comprises an inlet flow meter (49) placed on the inlet pipe (14a) upstream of the branch and an effluent line flow meter (42) on the effluent line (13), wherein, at least in the main operating mode (and optionally also in the second operating mode and the third operating mode), the control unit (12) receives signals from the inlet flow meter (49) and the effluent line flow meter (42) to control the ultrafiltration rate through the dialyzer.

[0188] In a hundredth aspect according to any one of the preceding aspects, the control unit (12) receives or calculates a set ultrafiltration rate to be achieved during extracorporeal blood treatment and drives the device to achieve the set ultrafiltration rate based on signals received from the inlet flow meter (49) and the effluent line flow meter (42), in particular based on the difference between the effluent flow (measured by the effluent line flow meter) and the sum of the infusion flow and the dialysis flow (measured by the inlet flow meter).

[0189] In a one hundred and first aspect according to any one of the preceding aspects, the inlet flow meter (49) and the effluent line flow meter (42) are implemented as differential flow meters.

[0190] In a 102nd aspect according to any of the preceding aspects, the fluid circuit (32) comprises a supply line flow meter (41) on the supply line (8), an infusion line flow meter (105) on the infusion line (109) and an effluent line flow meter (42) on the effluent line (13), wherein, in a main operating mode, the control unit (12) receives signals from the supply line flow meter (41), the infusion line flow meter (105) and the effluent line flow meter (42) to control the ultrafiltration rate through the dialyzer.

[0191] In a 103rd aspect according to any of the preceding aspects, the control unit (12) receives or calculates a set ultrafiltration rate to be achieved during extracorporeal blood treatment and drives the device to achieve the set ultrafiltration rate based on signals received from the supply line flow meter (41), the infusion line flow meter (105) and the effluent line flow meter (42), in particular based on the difference between the effluent flow and the sum of the infusion flow (measured by the infusion line flow meter (105)) and the dialysis flow.

[0192] In a 104th aspect according to any one of the preceding aspects, the supply line flow meter (41) and the effluent line flow meter (42) are implemented as differential flow meters.

[0193] In a 105th aspect according to any of the preceding aspects, the control unit (12) is configured to control one or more of the shut-off elements between an open position and a closed position to allow or prevent fluid communication between the infusion line (109) and the supply line (8).

[0194] In a 106th aspect according to any of the preceding aspects, the fluid circuit (32) defines a fluid line network comprising a dialysis preparation assembly (9), an infusion preparation assembly (108), an infusion line (109), a supply line (8) and a shut-off element,

[0195] The dialysis preparation component (9), the infusion preparation component (108), the infusion line (109) and the supply line (8) are interconnected through the fluid pipeline network and can be fluidically connected to each other based on the open position or closed position of the shut-off element. In particular, the control unit is configured to control the shut-off element to define different flow paths within the fluid circuit (32).

[0196] In a 107th aspect according to any of the preceding aspects, the control unit (12) is configured to control one or more of the shut-off elements between an open position and a closed position to allow or prevent fluid communication between the dialysis preparation assembly (9) and the infusion preparation assembly (108).

[0197] In a 108th aspect according to any one of the preceding aspects, the dialysis preparation component (9) and the infusion preparation component (108) are interconnected by fluid lines, the fluid lines defining a fluid line network including shut-off elements, the control unit (12) being configured to control one or more of the shut-off elements between an open position and a closed position to define two or more fluid paths for a mixed solution for dialysis fluid and a mixed solution for infusion fluid.

[0198] In a 109th aspect according to the preceding aspects, the two or more fluid paths include at least one fluid path in which the fluid prepared by the dialysis preparation component (9), in particular the mixed solution of dialysis fluid, is not mixed with the fluid prepared by the infusion preparation component (108), in particular the mixed solution of infusion fluid, and another fluid path, wherein the fluid path is any one of the following:

[0199] The fluid prepared by the dialysis preparation component (9) enters the infusion preparation component (108);

[0200] The fluid prepared by the infusion preparation component (108) enters the dialysis preparation component (9);

[0201] • The fluid prepared by the dialysis preparation assembly (9) is mixed with the fluid prepared by the infusion preparation assembly (108).

[0202] In an aspect 110 according to any of the preceding aspects, the fluid flow configuration comprises at least a second operating mode, wherein the dialysis preparation component (9) and the infusion preparation component (108) cooperate to prepare an auxiliary mixed solution of dialysis fluid, in particular an auxiliary mixed solution of dialysis fluid that is different from the mixed solution of dialysis fluid and the mixed solution of infusion fluid.

[0203] In a 111 aspect according to anyone of the preceding aspects, the fluid flow configuration comprises at least a second operating mode, wherein the control unit is configured to control the shut-off element to mix the mixed solution of the dialysis fluid with the mixed solution of the infusion fluid, thereby defining a secondary mixed solution of the dialysis fluid.

[0204] In a 112th aspect according to any one of the preceding aspects, the control unit (12) is configured to control one or more of the shut-off elements between an open position and a closed position to allow or prevent fluid communication between the dialysis preparation component (9) and the infusion preparation component (108), in particular to allow or prevent fluid communication between the mixed solution of dialysis fluid prepared in the dialysis preparation component (9) and the infusion preparation component (108), or to allow or prevent fluid communication between the mixed solution of infusion fluid prepared in the infusion preparation component (108) and the dialysis preparation component (9). BRIEF DESCRIPTION OF THE DRAWINGS

[0205] Some embodiments and aspects of the present invention will be described below with reference to the accompanying drawings, which are provided for illustration purposes only, in which:

[0206] - Figure 1 is a schematic diagram of a blood processing apparatus according to an embodiment of the present specification;

[0207] - Figure 2 and Figure 3 is a schematic diagram of a fluid path configuration of a blood processing apparatus according to an embodiment of the present specification;

[0208] - Figure 4 is a more detailed schematic diagram of a blood processing apparatus according to an embodiment of the present specification;

[0209] - Figure 5 is a block diagram illustrating the method described herein for blood processing.

[0210] definition

[0211] In this detailed description, corresponding parts shown in the various figures are denoted by the same reference numerals. The figures may illustrate the present invention by non-scale representations; therefore, parts and components shown in the figures relevant to the purpose of the present invention may only be related to schematic representations.

[0212] Upstream and / or Downstream

[0213] The terms "upstream" and "downstream" refer to the direction or trajectory of fluid progress during normal use of the device, in particular the direction or trajectory of blood in a blood circuit and dialysis fluid / infusion fluid in a dialysis line / infusion line, wherein the fluid is configured to flow along the fluid line during extracorporeal blood treatment. DETAILED DESCRIPTION

[0214] Blood processing device 1

[0215] Figure 4 An extracorporeal blood treatment apparatus 1 according to a general embodiment is shown. An example of a hydraulic circuit 200 is also shown in FIG. Figure 4 It is schematically shown in FIG. 2 , but it should be noted that the specific structure of the hydraulic circuit 200 is irrelevant to the purpose of the present invention, so it can be used according to the function and design requirements of each single medical device. Figure 4 Other circuits different from the circuits specifically shown in FIG. Figure 1 、 Figure 2 and Figure 3 A slightly different embodiment of the hydraulic circuit 200 is also shown according to a simplified scheme to highlight the main components of the hydraulic circuit of the present disclosure in one or more operating configurations.

[0216] The hydraulic circuit 200 shows a dialysis fluid circuit 32, which includes at least one dialysis fluid supply line 8. Typically, the dialysis fluid supply line 8 is a tube through which the dialysis fluid being prepared flows, i.e., a main line that receives water and concentrate (or concentrates) and transports the prepared dialysis fluid toward the filtration unit and / or directly into the extracorporeal blood circuit. Depending on the device processing mode, the dialysis fluid supply line 8 may or may not adopt a different hydraulic circuit line configuration. In hemodialysis (HD) processing mode, the supply line 8 is intended to transport dialysis fluid from the dialysis preparation component 9 toward the processing station 15, where one or more filtration units 2 or dialyzers are operated. The dialysis fluid and blood are exchanged primarily by diffusion through the semipermeable membrane 5 in the filtration unit 2. In the hemofiltration (HF) treatment mode, the supply line 8 includes an auxiliary infusion line 39, which is intended to transport fluid from the supply line 8 to the blood circuit: in particular, the auxiliary infusion line 39 is connected to the supply line at a branch point 46 and to the blood circuit at an access point 19, which access point 19 is placed, for example, in correspondence with an air separator configured to remove gases from the blood before infusion. The auxiliary infusion line 39 may include an ultrafilter 44 to additionally filter the fluid received upstream of the access point 19 into the blood circuit. The removal of waste from the blood is achieved by using large amounts of ultrafiltration while simultaneously reinfusing the sterile replacement fluid in the blood circuit. In the hemodiafiltration (HDF) treatment mode, the supply line 8 is intended to transport the dialysis fluid from the dialysis preparation component 9 towards the treatment station 15, and further includes an auxiliary infusion line 39 to transport the fluid to the blood circuit 17. HDF is a combination of hemodialysis and hemofiltration. In general, the fluid circuit 32 is a fluid circuit that is designed to deliver HF treatment, HD treatment, and HDF treatment, despite the fact that different fluid circuits 32 may be used (e.g., with associated lines dedicated to the intended treatment (e.g., no auxiliary infusion line 39 for HD, no inlet line 45 for HF)). Figure 4 and comprises an auxiliary infusion line 39 connected to the blood circuit and an inlet line 45 connected to the inlet of the filtration unit 2, wherein the device control unit 12 can then control the passage of the fluid through the lines, for example by appropriate shut-off elements (such as valves or clamps), depending on the selected treatment.

[0217] The dialysis fluid circuit 32 also comprises at least one dialysis effluent line 13 intended to carry the dialysate liquid (spent dialysate and liquid ultrafiltered from the blood through the semipermeable membrane 5) from the treatment station 15 towards a drain area (at Figure 4 The fluid circuit 32 cooperates with the blood circuit 17, which also has its basic components in part. Figure 4 The specific structure of the blood circuit is not essential for the present invention. Figure 4 , a possible embodiment of a blood circuit is briefly described, which however is provided merely by way of non-limiting example. Figure 1 The blood circuit 17 comprises a blood extraction line 6 designed to remove blood from the vascular access 18 and a blood return line 7 designed to return processed blood to the vascular access 18 . Figure 4 The blood circuit 17 also includes the primary chamber 3 (or blood chamber) of the blood filtration unit 2, while the secondary chamber 4 of the blood filtration unit 2 is connected to the supply line 8. In more detail, the blood withdrawal line 6 is connected to the inlet of the primary chamber 3, and the blood return line 7 is connected to the outlet of the primary chamber 3. In an embodiment, the blood return line 7 and / or the blood withdrawal line 6 are part of a disposable kit: these lines can be made of a transparent material (i.e., plastic or PVC or silicone) so that the fluid flowing inside the line is visible from the outside.

[0218] In turn, a dialysis fluid supply line 8 is connected at the inlet of the secondary chamber 4 , whereas a dialysis effluent line 13 is connected at the outlet of the secondary chamber 4 .

[0219] The filtration unit 2 (eg dialyzer or plasma filter or blood filter or hemodiafiltration filter) comprises two chambers 3 and 4 as described above, which are separated by a semipermeable membrane 5, eg of hollow fiber or plate type.

[0220] The blood circuit 17 may also comprise one or more air separators 19: in particular, Figure 4 As shown, the device may include an air separator 19 on the blood return line 7. An auxiliary air separator may also be provided on the blood withdrawal line 7.

[0221] The device further comprises safety clamps 20a, 20b arranged close to the patient's vascular access 18: in particular, the device may include a blood return safety clamp 20a and a blood withdrawal safety clamp 20b, which are respectively arranged on the blood return line 7 and the blood withdrawal line 6. In accordance with the assumed direction of blood flow during the dialysis treatment from the blood withdrawal line 6 through the filter unit 2 and towards the blood return line 7, the blood return safety clamp 20a is arranged downstream relative to the air separator 19 of the blood return line 7. The safety clamps 20a, 20b can be activated by the control unit 12 (and / or manually) to close the blood return line 7 and the blood withdrawal line 6 when it is necessary to isolate the vascular access 18, for example for safety reasons.

[0222] The extracorporeal blood treatment apparatus 1 may further comprise one or more blood pumps 21 (eg positive displacement pumps such as peristaltic pumps) arranged on the blood circuit 17: Figure 4 In the example of the embodiment of the present invention, the blood pump 21 is arranged on the blood withdrawal line 6, in particular interposed between the filter unit 2 and the vascular access 18. In another embodiment, more than one blood pump 21 may be arranged on the blood circuit 17, for example, a first blood pump may be arranged on the withdrawal line 6 and a second blood pump may be arranged on the return line 7. The blood return line 7 extends between a first end connected to the outlet of the main chamber 3 of the filtration unit 2 and a second end for connection to the patient: similarly, the blood withdrawal line 6 extends between a first end connected to the inlet of the main chamber 3 of the filtration unit 2 and a second end for connection to the patient.

[0223] The apparatus of the above-described embodiment further comprises a control unit 12 (i.e., a programmable control unit), and a user interface 22 (e.g., a graphical user interface or GUI) connected to the control unit 12 to allow a user to command one or more treatment operations or to visualize on a screen one or more parameters related to blood treatment. For example, the control unit 12 may comprise one or more digital microprocessor units or one or more analog units or other combinations of analog and digital units. By way of example, with respect to a microprocessor unit, once the unit has executed a specific program (e.g., a program from an external source or a program directly integrated on a microprocessor card), the unit is programmed, thereby defining a plurality of functional blocks, each of which constitutes a means for performing a respective operation as better described in the following description.

[0224] In combination with one or more of the above features, the medical device may further comprise a shut-off / bypass device operating in the dialysis fluid circuit 32 and commandable between a first operating condition in which the shut-off device allows liquid to flow towards the filtration unit 2 and a second operating position in which the shut-off device blocks the passage of liquid towards the filtration unit 2. In this case, the control unit 12 may be connected to the shut-off device and programmed to drive the shut-off device to transition from the first operating condition to the second operating condition if an alarm condition has been detected. The shut-off device may comprise a bypass line 23 connecting the dialysis fluid supply line 8 and the dialysate effluent line 13, thereby bypassing the dialyzer, and one or more fluid check members 24 connected to the control unit 12 to selectively open and close the bypass line 23. The components (bypass line 23 and fluid check members 24) are in Figure 4The non-return member 24 closes the fluid passage towards the treatment area according to the command of the control unit and connects the supply line 8 directly to the dialysis effluent line 13 via the bypass line 23 .

[0225] Again, in order to control the fluid passage towards the filtration unit 2, a dialysis fluid pump 25 and a dialysate pump 26 may be provided, which are located on the dialysis fluid supply line 8 and the dialysate effluent line 13, respectively, and are also operatively connected to the control unit 12.

[0226] The device further comprises one or more water inlet pipes 14a for receiving water from a water source 14: the water source 14 may comprise a purification system (e.g., an RO system) arranged upstream relative to the water inlet pipe 14a and configured to provide purified water, in particular distilled water / sterile water, to the water inlet pipe. In other words, the inlet pipe 14a is configured to be connected to a tap water network (i.e., a supply of tap water that is filtered by the purification system) that is capable of providing a continuous and essentially endless supply of water. It is worth noting that the water source 14 does not actually belong to the device 1, which is configured to be connected to the water source 14 via the water inlet pipe 14a. The quality of the incoming water should generally comply with the ISO 13959 standard.

[0227] Although the device may comprise more than one inlet pipe 14a intended to receive water, Figure 4 As shown, the device may include one and only one single inlet pipe 14a, which is configured to be fluidically connected to a water source 14 so that water is supplied to the device through the single inlet pipe 14a. For safety reasons, a shut-off element such as a hydraulic valve may be arranged at the beginning of the inlet pipe 14a: the shut-off element is movable between a closed position preventing the flow of water and an open position allowing the flow of water.

[0228] The device 1 includes at least one shut-off element arranged and operable on a fluid circuit 32, the shut-off element being connected to a control unit 12, which in turn is configured to independently move one or more shut-off elements between an open position and a closed position. The shut-off element may comprise a clamp (i.e., acting externally to the fluid line) or a hydraulic valve acting via a flap within the fluid flow. The shut-off element described below is based on the above-described features.

[0229] The apparatus further comprises a dialysis fluid preparation assembly 9, which is fluidically interposed between the inlet pipe 14a and the supply line 8. The dialysis fluid preparation assembly 9 comprises one or more concentrate sources 27, 28 containing respective concentrate solutions and is configured to prepare a mixed solution of the dialysis fluid. The water inlet pipe 14a is configured to supply water to the dialysis preparation assembly 9 for preparing the mixed solution constituting the dialysis fluid. In particular, the dialysis preparation assembly 9 is configured to mix water from the water pipe 14 with the concentrate solutions of the sources 27, 28, in order to provide the resulting mixed solution of the dialysis fluid to the supply line 8. The dialysis fluid preparation assembly 9 includes a first preparation line 9a, which is fluidically interposed between the inlet tube 14a and the supply line 8 and is configured to receive concentrate solution from sources 27, 28 via delivery lines 36, 37, respectively. The delivery lines 36, 37 in turn include respective concentrate pumps 29, 30 configured to determine the flow of concentrate from the concentrate source to the first preparation line 9a. Flow sensors (not shown) connected to the control unit 12 may also be provided on the delivery lines 36, 37 of the concentrate sources 27, 28 to monitor the amount of concentrate delivered to the first preparation line 9a.

[0230] Typically, the first preparation line 9a includes one or more sensors configured to monitor a property of the fluid flowing along the line itself; this property may be the fluid's conductivity or the concentration of ionic species. More specifically, a sensor 49 is typically present on the first preparation line 9a downstream of the mixing point where it receives the first delivery line 36; another sensor 35 is present on the first preparation line 9a downstream of the mixing point where it receives the second delivery line 37. Sensor 49 can measure the conductivity of the fluid flowing in the first preparation line 9a after it mixes with the first concentrated solution 27 and before it receives the second concentrated solution. The control unit 12 receives the signal from the conductivity sensor 49 and can adjust the concentrate pump 29 to appropriately adjust the concentrate delivery rate to achieve a specified conductivity target. Similarly, sensor 35 can measure the conductivity of the fluid flowing in the first preparation line 9a after it mixes with the second concentrated solution 28. The control unit 12 receives the signal from the conductivity sensor 35 and can regulate the concentrate pump 30 to appropriately adjust the infusion rate of the concentrate to achieve the specified conductivity target from the combined infusion of concentrates 27 and 28. The same control routine can be performed using an appropriate concentration sensor instead of a conductivity sensor. Alternatively, only one sensor (in the present case, sensor 35) downstream of all infusion points can be used to control the overall conductivity of the dialysis fluid.

[0231] Figure 4Two concentrate sources 27, 28 are shown connected to the first preparation line 9a. In any case, in one embodiment, a single concentrate source may be used, or in another embodiment, additional concentrate sources containing corresponding concentrate solutions may be provided. Of course, if only one concentrate solution is used, only one conductivity / concentration sensor may be used. If more than two concentrates are used, a sensor may be used downstream of each mixing point.

[0232] It should also be noted that the preparation assembly may include multiple connections, lines, and pumps, respectively, for the concentrates, and that only one line or a lesser number of lines may be used.

[0233] According to a first general embodiment, the concentrate sources 27, 28 of the dialysis preparation assembly 9 comprise one or more concentrates from the group between sodium chloride, calcium chloride, magnesium chloride, potassium chloride, buffers (e.g. bicarbonate) and other components such as citrate, dextrose and acetate.

[0234] Typically, concentrate container A (eg, container 27) includes primary electrolyte, while concentrate container B (eg, container 28) includes sodium chloride and a buffer.

[0235] In one embodiment, a concentrate container 27; 28 contains a (e.g., liquid) concentrate comprising calcium chloride, magnesium chloride, potassium chloride, dextrose, and optionally citrate. Upon dilution into water, a solution comprising the following components is prepared:

[0236] <![CDATA[K + ]]> 0-5(1-4)* mmol / l <![CDATA[Ca ++ ]]> 1.2-2(1.4-1.8)* mmol / l <![CDATA[Mg ++ ]]> 0.3-0.7(0.5)* mmol / l <![CDATA[Cl - ]]> 100-120(107-112)* mmol / l Cit(opt) 0-2(1)* mmol / l <![CDATA[Glucose / C6H 12 O6]]> 0-2(0-1)* mmol / l

[0237] *Narrower concentration ranges are shown in brackets.

[0238] Another concentrate container 28, 27 contains (e.g., dry) concentrate, which includes sodium bicarbonate. If a powder concentrate is used in concentrate container B, some water is overflowed from preparation line 9a (or from inlet 14a) to pre-dilute the concentrate, allowing the concentrate pump to produce a concentrate flow. After dilution into the main preparation line 9a, the solution also includes sodium ions and bicarbonate ions. The sodium ions are in the range between 120 and 170 mmol / l, particularly between 120 and 160 mmol / l (e.g., approximately 140 mmol / l). The bicarbonate ions are in the range between 20 and 40 mmol / l, particularly between 24 and 38 mmol / l (e.g., approximately 34 mmol / l). Of course, the sodium concentration in the dialysis fluid can be set according to the patient's prescription.

[0239] By mixing both concentrates A and B, a dialysis fluid suitable for use in HD, HF and HDF treatments is obtained.

[0240] Generally speaking, the dialysis preparation assembly 9 prepares the dialysis fluid "on-line" by infusing sodium chloride plus other ionic substances and buffers in appropriate ratios to each other into the first preparation line 9a.

[0241] In other words, the dialysis fluid preparation assembly 9 is configured to perform online dialysis fluid preparation by mixing water with a predetermined amount of one or more concentrated substances. The expression "online" refers to a fluid preparation in which the water is supplied by a mains water network capable of providing a substantially unlimited supply of water (i.e. purified water): the expression "online" is therefore used to distinguish it from an embodiment in which a ready-to-use dialysis bag or tank with a limited capacity is used as a source of treatment fluid.

[0242] The fluid circuit 32 also includes an infusion preparation assembly 108, which is separate and distinct from the dialysis preparation assembly 9 and includes one or more concentrate sources 102 containing one or more corresponding concentrate solutions 103, such as Figure 4 As shown. The concentrate source 102 may include only one reservoir for containing the concentrated solution 103. The infusion preparation component 108 is fluidly inserted between the inlet tube 14a and the infusion line 109 and is connected to the inlet tube 14a and the infusion line 109, and the infusion preparation component 108 is configured to prepare a mixed solution of infusion fluid by mixing water supplied by the inlet tube 14a with one or more concentrated solutions 103. The fluid prepared by the infusion preparation component 108 is called "infusion fluid" to distinguish it from the treatment fluid prepared by the dialysis preparation component 9, which is called "dialysis fluid". However, the different names are for the purpose of specifically and clearly distinguishing between the two different fluids, and do not imply that the "dialysis fluid" may not be infused into the blood circuit, and the "infusion fluid" may not be transported to the second chamber 4 of the filtration unit.

[0243] Despite the fact that a different embodiment of the infusion preparation assembly 108 is shown in the figures than the embodiment of the dialysis preparation assembly 9 , it should be noted that the arrangement of containers, fluid lines and concentrate pumps may be the same for both preparation assemblies 9 , 108 .

[0244] However, since the two preparation components 9, 108 are independent of each other and are both controlled by the control unit 12 according to the treatment needs, different medical fluids can be prepared at the same time, for example, one for infusion into the blood circuit and the other for delivery to the dialyzer. Both medical fluids are suitable for treating patients (i.e., both can be infused into extracorporeal blood and / or guided to the secondary chamber of the filtration unit to exchange with the blood through the semipermeable membrane), but they have different compositions in terms of solute properties and / or solute concentrations. Figure 4As shown in the figure, the fluid circuit 32 can also be provided with a shut-off element 100a, i.e., an inlet valve 100a, i.e., a hydraulic valve or a clamp, which is connected to the control unit 12 and inserted between the infusion fluid preparation component 108 and the inlet tube 14a, thereby allowing or blocking the flow of water toward the infusion fluid preparation component 108.

[0245] According to the structure of the fluid circuit 32 described above, the water inlet pipe 14a is configured to independently supply water to both the dialysis preparation assembly 9 and the infusion preparation assembly 108. In other words, the water inlet pipe 14a is configured to independently supply water to one or both of the first preparation line 9a and / or the second preparation line 108a: thus, the first preparation line 9a and the second preparation line 108a together define independent branches of the fluid circuit 32 supplied by the same water source 14. Pure water enters the infusion fluid preparation assembly 108.

[0246] The infusion preparation assembly 108 includes a second preparation line 108a where mixing of the concentrated solution 103 with water occurs.

[0247] As mentioned according to an embodiment not shown in the drawings, the concentrated source 102 can be connected to the second preparation line 108a via a delivery line provided with a pump or a delivery means connected to the control unit 12, and is configured to provide a desired amount of concentrated substance into the second preparation line 108a. In other words, the pump or the delivery means is configured to deliver a predetermined amount of concentrated solution 103 into the second preparation line 108a so as to prepare a mixed solution of the infusion fluid having a desired substance concentration. Alternatively, as Figure 4 As shown, water is supplied from inlet pipe 14a to the concentration source 102 to obtain a mixed solution.

[0248] In particular, in one embodiment, the concentrated solution 103 can be a concentrated solution of sodium bicarbonate (e.g., sodium bicarbonate powder or a dry concentrate of sodium bicarbonate). In this configuration, water is fed to the powder solution to prepare a saturated bicarbonate solution (see Figure 4 For example, a water branch may exit water line 100 and enter concentrate source 102 ( Figure 1 ). The injection line and corresponding pump (on tube 108a) can then deliver the appropriate amount of saturated solution to the water line 100 or mixing chamber 102a (where the water line 100 also has an inlet) so that any diluted bicarbonate solution flowing toward the infusion line 109 can be obtained. Figure 1 As shown schematically, the concentrate source 102 can be arranged parallel to the second preparation line 108a, such that both the inlet and outlet of the concentrate source 102 are fluidly connected to the second preparation line 108a. According to this embodiment, water is allowed to partially bypass the concentrate source 102, thereby obtaining any variable substance concentration in the infusion fluid.

[0249] according to Figure 1 In the illustrated embodiment, a mixing chamber 102a can be disposed on a second preparation line 108a downstream of the concentrate source 102 of the infusion fluid preparation assembly 108: the mixing chamber is configured to allow the concentrated solution 103 (i.e., a solution saturated with bicarbonate) to mix with water supplied by the inlet tube 14. A conductivity sensor can also be disposed within or downstream of the mixing chamber 102a to provide a conductivity signal representing the conductivity of the mixed solution indicative of the concentration of the substance.

[0250] Alternatively, a concentrated liquid solution of (e.g., sodium) bicarbonate may be used. In this case, a water branch may not be required to produce a saturated liquid solution. The concentrated solution 102 can be appropriately metered along the infusion line to the water line 100 (not shown in this embodiment) by a corresponding pump. Furthermore, the infusion preparation assembly 108 can have a hydraulic circuit configuration identical / similar to that of the dialysis fluid preparation assembly 9. In other words, more than one concentrated substance can be infused into the water line 100 to prepare a suitable infusion fluid. The difference is that the prepared treatment fluid will have a different composition than the treatment fluid prepared by the dialysis fluid preparation assembly 9. Note that the same concentrate container can ultimately be installed in both the dialysis fluid preparation assembly 9 and the infusion preparation assembly 108; however, the control unit will drive one or more corresponding infusion pumps differently, so that fluids with different conductivities and / or different concentrations of predetermined substances (e.g., sodium ions and / or calcium ions and / or potassium ions and / or magnesium ions) will be produced for subsequent use in treating the patient. Alternatively, concentrate containers with different substance concentrations can be used to prepare fluids containing different proportions of the various substances. More specifically, the composition of the mixed solution of the dialysis fluid differs from that of the mixed solution of the infusion fluid. Thus, the device is suitable for online preparation of two different treatment fluids, which are ready to be delivered to the second chamber of the filtration unit and / or directly infused into the extracorporeal blood circuit.

[0251] Operating as described above allows for additional freedom in controlling substance infusion; thus, for example, different targets can be set for substance concentrations within the patient's blood (such as sodium concentration and potassium concentration), and these independent targets can be achieved at the end of treatment by appropriately analyzing the concentrations of these substances in the dialysis fluid and the infusion fluid.

[0252] Back to Figure 4The fluid circuit 32 may further include a sensor 104, in particular a conductivity sensor 104, which is arranged on a second preparation line 108a downstream of the outlet of the concentrate source 102. In particular, the conductivity sensor 104 is configured to provide a signal representing the conductivity of the mixed solution of the infusion fluid. The control unit 12 is connected to the conductivity sensor 104 and is configured to receive and process (elaborate) the conductivity signal: in particular, the control unit drives the infusion fluid preparation component 108 to prepare the mixed solution of the infusion fluid based on a comparison between the target conductivity value of the infusion fluid and the actual conductivity value of the infusion fluid measured by the conductivity sensor 104. Alternatively, the sensor 104 on the second preparation line 108a may variously include a concentration sensor (e.g., an ion-selective sensor) configured to measure the concentration of at least one substance in the infusion fluid (e.g., sodium concentration). In this case, the control unit 12 may be configured to prepare a mixed solution of the infusion fluid based on a comparison between the target concentration value of the infusion fluid and the actual concentration value of the infusion fluid measured by the concentration sensor 104. Of course, if there is more than one concentrate container, a (conductivity or concentration) sensor may be present at or downstream of each mixing point.

[0253] The fluid circuit 32 may further include a flow meter 105 disposed on a second preparation line 108a downstream of the one or more concentrate sources 102 of the infusion fluid preparation assembly 108 and configured to provide a signal representing the flow rate of the mixed solution of the infusion fluid. The control unit 12 is connected to the flow meter 105 and configured to receive and process the flow rate signal.

[0254] The fluid circuit 32 also includes an infusion fluid pump 106, which is connected to the control unit 12, arranged on the infusion line 109 and configured to determine the flow rate of the infusion fluid. The control unit 12 is configured to control the start, stop and speed of the infusion fluid pump 106 so that the desired flow rate of the infusion fluid is generated in the pipeline. The control unit 12 can also be configured to control the infusion pump 106 to change the flow rate based on at least one of the measured conductivity and flow signal related to the mixed solution of the infusion fluid and / or at least one of the measured conductivity and flow signal related to the mixed solution of the dialysis fluid. The fluid circuit 32 can also include an infusion ultrafilter 107, which is arranged on the infusion line 109 between the infusion fluid preparation component 108 and the access port 19, in particular, downstream of the infusion pump 106 and the concentrate source 102. In particular, as Figure 2 and Figure 3 As shown, the infusion ultrafilter 107 may include a first infusion ultrafilter 107a and a second infusion ultrafilter 107b connected in series to each other.

[0255] The aforementioned infusion line 109 is fluidically connected to the outlet of the infusion fluid preparation assembly 108 and the access point 19 of the blood circuit 17, and is interposed between the outlet of the infusion fluid preparation assembly 108 and the access point 19 of the blood circuit 17. The infusion line 109 is configured to carry the mixed solution of the infusion fluid from the infusion fluid preparation assembly 108 to the blood circuit 17 for infusion into the patient. Alternatively, the infusion line 109 can also be directly connected to the patient's vascular access. A shut-off element 109a (i.e., an infusion valve 109a) is provided on the infusion line 109 and is configured to allow or prevent the passage of the mixed solution of the infusion fluid toward the blood circuit 17. An additional infusion fluid pump 111 may also be provided on the infusion line 109 downstream of the filter 107 (if necessary): in particular, the infusion fluid pump 111 may be a volumetric pump (if inside the body) or an occlusive pump (e.g. a peristaltic pump), and is connected to the control unit 12, which is configured to control the fluid pump 111 to determine the desired flow rate of the infusion fluid toward the patient. Note that Figure 4 Two independent pumps are provided for infusing fluid into the extracorporeal blood circuit, namely pump 111 and pump 43. Obviously, the infusion line 109 can alternatively be connected directly to the infusion line 39 of the pump 43 (e.g., the infusion line 39 upstream of the pump 43). If the infusion line is connected upstream of the ultrafilter 44, for example at the branch 46, then Figure 2 and Figure 3 The two ultrafilters 107a and 107b can be consistent with ultrafilters 107 and 44.

[0256] Furthermore, the infusion line 109 is shown to infuse the infusion fluid directly in a post-infusion, in particular directly into the air separator 19. Of course, the post-infusion can take place in any other location in the blood return line or, in this case, in any other location in the blood withdrawal line 6, for example in a location between the blood pump 21 and the filtration unit 2. The fluid circuit 32 can also comprise a bridge line 110, which is inserted in the fluid connection between the infusion line 109 and the supply line 108. In particular, the bridge line 110 is connected to the supply line 8 at a branch point 112, which is located downstream of the concentrate sources 27, 28 of the dialysis fluid preparation assembly 9 and optionally upstream of the conductivity sensor 35 and the flow meter 41 ( Figure 4 Alternatively, the bridge line 110 can be connected to the first preparation line 9a at a branch point located upstream of the concentrate sources 27, 28 of the dialysis fluid preparation assembly 9. Figure 2. This configuration is shown in . A shut-off element 110a (i.e., a bridge valve 110a) may also be arranged on the bridge line 110 to allow or prevent the passage of fluid between the infusion line 109 and the supply line 108. When the mixed solution of the infusion fluid is delivered into the supply line 8, the infusion fluid and the dialysis fluid are mixed, thereby defining an auxiliary mixed solution of the dialysis fluid, which is directed to the inlet of the secondary chamber 4 of the filtration unit 2. The fluid circuit 32 also includes a sensor 35, which is arranged on the supply line 8 or the first preparation line 9a downstream of the concentrate source 27, 28 of the dialysis fluid preparation component 9. The control unit 12 is connected to the conductivity sensor 35 and is configured to receive and process the conductivity signal: in particular, when the infusion preparation component is delivered to the upstream ( Figure 2 ) or downstream ( Figure 4 ) When the infusion fluid is injected, the sensor 35 monitors the conductivity or concentration of the auxiliary mixed solution of the dialysis fluid before it reaches the filtration unit 2.

[0257] The fluid line 32 may further include a flow meter 41, which is arranged on the supply line 8 downstream of the dialysis fluid preparation assembly 9 (an additional flow meter 105 is provided in the first preparation line 9a). Specifically, the flow meter 41 is arranged downstream of the concentrate sources 27, 28 of the dialysis fluid preparation assembly 9 and is configured to provide a signal representing the flow rate of the mixed solution of the dialysis fluid. Alternatively, the flow meter 41 is configured to provide a signal representing the flow rate of both the mixed solution of the dialysis fluid and the auxiliary mixed solution of the dialysis fluid when the infusion fluid prepared online is delivered to the supply line 8 via the bridge line 110. The control unit 12 is connected to the flow meter 41 and is configured to receive and process the flow rate signal.

[0258] The fluid circuit 32 further comprises a dialysis fluid pump 25 connected to the control unit 12, arranged on the supply line 8 and configured to determine the flow rate of the dialysis fluid. The control unit 12 is configured to control the start, stop and speed of the fluid pump 25, thereby determining the desired dialysis flow rate.

[0259] The fluid circuit 32 may also comprise a further semipermeable membrane filter (not shown in the figures) which is arranged on the supply line 8 between the dialysis fluid preparation assembly 9 and the filtration unit 2 , in particular downstream of the dialysis pump 25 .

[0260] The supply line 8 can branch off at a branch point 46 into an auxiliary infusion line 39. Figure 4In the example of , the auxiliary infusion line 39 is shown as being directly connected to the blood return line 7, in particular being connected to the air separator 19 (solid line) via the rear infusion conduit 47b. Alternatively, the infusion line 39 can infuse the infusion fluid in the blood extraction line 6 via the front infusion conduit 47a (in particular, at the front infusion branch point 48 downstream of the blood pump 21 (dashed line)). An embodiment includes an infusion line 39 that branches into a front infusion branch 47a and a rear infusion branch 47b, which respectively guide the infusion fluid in the blood extraction line 6 and the blood return line 7. One or more infusion pumps 43 can be used to pump the desired infusion liquid flow into the blood circuit. The infusion pump 43 can be a positive displacement pump (e.g., a peristaltic pump as shown) or any other pump configured to transfer infusion fluid (e.g., a volumetric pump).

[0261] The dialysis effluent line 13 can be provided with a dialysate pump 26 and a flow meter 42. The respective flow meters 41, 42 of the dialysis supply line 8 and the dialysis effluent line 13 (and, if necessary, a flow meter 105 on the auxiliary preparation line) can be used to control the fluid balance of the patient connected to the blood circuit 17 during a dialysis session. A sensor 11 is also provided on the dialysis effluent line 13 immediately downstream of the filtration unit 2 to measure a parameter value of the dialysate in the dialysate effluent line 13. More specifically, the dialysate parameter measured by the sensor 11 is the conductivity of the dialysate or the concentration of at least one substance in the dialysate. Specifically, the sensor 11 is a conductivity sensor connected to the dialysis effluent line 13 and configured to detect the conductivity value of the dialysate downstream of the filtration unit 2. Alternatively (or in combination), the sensor 11 may include a concentration sensor configured to measure the concentration of at least one substance in the dialysate, such as sodium concentration. Furthermore, the apparatus may further include a disinfectant source 33 (i.e., a disinfectant solution) connected, for example, to the first preparation line 9a or the inlet pipe 14a via a delivery line 38. A shut-off element 31 (i.e., a clamp or hydraulic valve) connected to and commanded by the control unit 12 may also be arranged on the delivery line 38 of the disinfectant source 33.

[0262] A shut-off element 34 (i.e., an inlet valve 34) may be provided on the first preparation line 9a and interposed between the water inlet pipe 14a and the concentrate sources 27, 28 of the dialysis preparation assembly 9. In particular, the inlet valve 34 is arranged upstream of any one of the concentrate sources 27, 28 of the dialysis fluid preparation assembly 9. In other words, the inlet valve 34, commanded by the control unit 12, allows or blocks the passage of water from the inlet pipe 14a to the dialysis fluid preparation assembly 9.

[0263] Figure 4The control unit 12 of the dialysis device represented in FIG is connected to a (graphic) user interface 22, via which the control unit 12 can receive instructions, for example, a patient prescription including target values ​​(e.g., blood flow, dialysis fluid flow, infusion fluid flow (pre-infusion and / or post-infusion), patient weight loss WL). The control unit 12 also receives the desired treatment among those that can be delivered by the device, for example, ultrafiltration, hemodialysis, hemofiltration, hemodiafiltration, or a specific treatment (e.g., AFB or AFBK treatment discussed briefly below). The control unit 12 can also receive values ​​detected by the device's sensors (e.g., the aforementioned flow meters 41, 42, the (e.g., conductivity) sensor 35 of the dialysis fluid preparation assembly 9, and the (e.g., conductivity) sensor 11 in the dialysis effluent line 13).

[0264] The control unit 12 is further configured to control one or more of the shut-off elements of the device 1 between a closed position and an open position in order to determine a fluid flow configuration defined according to the fluid path: in practice, the open position or the closed position of the shut-off element determines one or more fluid flow configurations, e.g. Figure 2 and Figure 3 shown. Figure 2 and Figure 3 A simplified scheme of the hydraulic circuit 200 is shown in order to highlight in a clearer and more direct manner the fluid paths within the hydraulic circuit according to the different operating modes.

[0265] From an operational perspective, the fluid flow configuration includes a primary operating mode, schematically shown in Figure 3 , in which a mixed solution of dialysis fluid can be supplied to the inlet of the secondary chamber 4 of the filtration unit 2 and a mixed solution of infusion fluid can be infused into the blood circuit 17 via an access point 19 . Figure 5A flow chart showing the steps performed by the control unit for conveying fluids in a main operating mode once the device has been provided (box 201) and the control unit has configured the hydraulic circuit in the arrangement to deliver two different fluids (i.e. a dialysis fluid and an infusion fluid) (box 202). In detail, in the main operating mode, water is allowed to reach the dialysis preparation assembly 9 (i.e. the control unit 12 opens the corresponding valve so that the water reaches the mixing point where the concentrate line injects the concentrate into the water (box 203). In the dialysis preparation assembly 9, the dialysis fluid is prepared by appropriately mixing the water and the concentrate and by controlling (at least) the conductivity of the prepared dialysis fluid (box 204); the outlet of the dialysis preparation assembly 9 is fluidically connected to the inlet of the secondary chamber 4 of the filtration unit 2 to supply the filtration unit with dialysis fluid for exchange with the blood (box 205). Essentially simultaneously, at the same time, In the same main operating mode, water is allowed to reach the infusion preparation assembly 108 (block 206). Here, the water is mixed with one or more concentrates of the infusion preparation assembly 108 to prepare an infusion fluid (block 207), and the outlet of the infusion preparation assembly 108 is fluidically connected to the access point 19 of the blood circuit 17 for infusion into the blood (block 208). According to the same main operating mode, while the mixed solution of the infusion fluid is being infused into the blood circuit 17, the mixed solution of the dialysis fluid can be supplied to the inlet of the secondary chamber 4 of the filtration unit 2. In an alternative embodiment not shown, it is necessary to Figure 3 With some minor flow path changes to the schematic diagram of FIG, but still according to the same main operating mode, a mixed solution of dialysis fluid can be continuously supplied to the blood circuit 17, while a mixed solution of infusion fluid can be supplied to the secondary chamber 4 of the filtration unit 2.

[0266] According to the above, the device is configured to perform online preparation of both a mixed solution of dialysis fluid to be supplied to the filtration unit 2 and a mixed solution of infusion fluid (in particular a mixed bicarbonate solution) to be infused into the blood circuit. It is worth noting that, in the main operating mode, the mixed solution of infusion fluid is not mixed with the mixed solution of dialysis fluid within the fluid circuit 32: therefore, in the main operating mode, the conductivity value of the mixed solution of dialysis fluid does not directly affect the conductivity value of the mixed solution of infusion fluid; the two treatment fluids remain separated and are delivered to the filtration unit and the blood circuit separately.

[0267] According to an embodiment, the main operating mode means that the inlet valves 34, 100a of the first preparation line 9a and the second preparation line 108a are in the open position, the bridge valve 110a is in the closed position, the dialysis fluid pump 25 determines the dialysis fluid flow towards the secondary chamber 4 of the filtration unit 2, and the infusion fluid pumps 106, 111 of the infusion line 109 determine the infusion fluid flow towards the access point of the blood circuit 17 or directly in the patient's vascular access.

[0268] The fluid flow configuration also includes a second mode of operation, such as Figure 2 , wherein a mixed solution of infusion fluid and a mixed solution of dialysis fluid are mixed, thereby defining an auxiliary mixed solution of dialysis fluid flowing in supply line 8. In a second operating mode, the auxiliary mixed solution of dialysis fluid can be supplied to the inlet of the secondary chamber 4 of the filtration unit 2 to allow blood treatment and / or can be supplied to the blood circuit at the infusion point 19 via line 109. It is worth noting that in the second operating mode, the dialysis preparation assembly 9 is fluidically connected in series upstream or downstream relative to the infusion preparation assembly 108: in other words, in the second operating mode, the first preparation line 9a is fluidically connected in series upstream or downstream relative to the second preparation line 108a. According to an embodiment, in the second operating mode, the dialysis preparation assembly 9 is fluidically connected downstream to the infusion preparation assembly 108. The expression "fluidically connected in series" refers to the fluid flow path within the circuit determined by the open or closed state of the shut-off element: therefore, the expression does not refer to the physical arrangement of the first and second preparation lines, which are still arranged as two branches connected to the same inlet pipe 14a.

[0269] It is worth noting that in the second operating mode, the auxiliary mixed solution of the dialysis fluid is prepared based on substances infused in the water flow by the dialysis preparation assembly 9 and the infusion preparation assembly 108, which are fluidically connected in series. Thus, in fact, the auxiliary mixed solution of the dialysis fluid is obtained by the subsequent infusion of different substances provided by both the dialysis preparation assembly 9 and the infusion preparation assembly 108.

[0270] The fact is that in the claims and the description, for the sake of consistency of wording, the auxiliary mixed solution of dialysis fluid is referred to as being obtained by mixing a "mixed solution of dialysis fluid" and a "mixed solution of infusion fluid": in fact, since the dialysis preparation assembly 9 and the infusion preparation assembly 108 are fluidically connected in series, there is no longer a sharp distinction between the "mixed solution of dialysis fluid" and the "mixed solution of infusion fluid", and in contrast, the auxiliary mixed solution of dialysis fluid results from the continuous addition of substances.

[0271] Furthermore, in the second operating mode, the shut-off element can be commanded so that an auxiliary mixed solution of the dialysis fluid is also (or exclusively) infused into the blood circuit 17. The fluid flow configuration can further include a third operating mode (using Figure 4108 ). The third operating mode comprises a hydraulic circuit (of a type 106) in which a mixed solution of infusion fluid and a mixed solution of dialysis fluid are mixed, thereby defining an auxiliary mixed solution of dialysis fluid flowing in the supply line 8 (similar to what occurs in the second operating mode): the auxiliary mixed solution of dialysis fluid can be supplied to the inlet of the secondary chamber 4 of the filtration unit 2. However, unlike the second operating mode, in the third operating mode, the dialysis preparation assembly 9 is fluidically connected in parallel with the infusion preparation assembly 108: in particular, in the third operating mode, the first preparation line 9a is fluidically connected in parallel with the second preparation line 108a, wherein the outlet of the first preparation line 9a and the outlet of the second preparation line 108a converge into the supply line 108. Furthermore, in the third operating mode, the shut-off element can be commanded so that the auxiliary mixed solution of dialysis fluid is also infused into the blood circuit 17. A graphical user interface 22 operatively connected to the control unit 12 is configured to receive one or more inputs from a user to select at least one fluid flow configuration, i.e., the primary operating mode, the second operating mode, or the third operating mode. In more detail, the main operating mode and the second operating mode can be used to provide different treatments with different dialysis solutions within the same dialysis device. In particular, the main operating mode ( Figure 3 ) can be used to deliver online acetate-free biofiltration (AFB) or acetate-free biofiltration with a potassium curve (AFBK). In this regard, the concentrate solution 103 is a buffer concentrate, particularly a sodium bicarbonate concentrate (e.g., such as from Baxter The buffer (eg bicarbonate) solution is used in combination with a dialysis fluid that is (essentially) free of buffer, in particular free of bicarbonate.

[0272] The patient's acid-base balance is regulated by appropriately regulating the infusion of the sodium bicarbonate solution prepared by the infusion fluid preparation component 108 .

[0273] At the same time, the dialysis fluid preparation assembly 9 prepares the dialysis fluid including the primary electrolytes. One or two concentrate containers or bags 27, 28 may be used. In a first example, an AFB treatment is provided in which the electrolyte content in the dialysis fluid is determined by a prescription and its relative electrolyte content is kept substantially constant throughout the treatment.

[0274] In the second example, AFBK treatment, two concentrate containers 27 and 28 are used. The two concentrates have different potassium concentrations and the same concentrations of other electrolytes. Therefore, by varying the infusion ratio between the two concentrate containers, potassium can be properly profiled during treatment. For example, the contents of the two concentrate bags 27 and 28 can include the following substances, after appropriate dilution, within the concentration ranges shown below:

[0275] Concentrate 1 Concentrate 2 Diluted concentrate <![CDATA[Na ++ ]]> <![CDATA[Na ++ ]]> 130-160(140)*mmol / l <![CDATA[K + ]]> 6,5-9(7,5)mmol / l <![CDATA[K + ]]> 0-3(0)*mmol / l <![CDATA[Ca ++ ]]> <![CDATA[Ca ++ ]]> 1-3(2)*mmol / l <![CDATA[Mg ++ ]]> <![CDATA[Mg ++ ]]> 0.2-0.6(0.4)*mmol / l <![CDATA[Cl - ]]> <![CDATA[Cl - ]]> 130-170 (140-160)*mmol / l <![CDATA[Glucose / C6H 12 O6]]> <![CDATA[Glucose / C6H 12 O6]]> 0-10(5.5)*mmol / l

[0276] * The concentration in brackets is narrower

[0277] According to this embodiment, the concentrate source 28 of the dialysis fluid preparation assembly 9 does not contain potassium, wherein a concentrate pump 30 is operable on a delivery line 37 to deliver a predetermined flow rate of a concentrated solution of other electrolytes to the first preparation line 9a, which is interposed between the concentrate source 28 and the first preparation line 9a. Concentrate source 27, in contrast, contains a slightly higher concentration of potassium, and concentrations of other ions similar to / identical to the concentrations of the same other ions in the concentrate source 28. The control unit 12 is further configured to command the dialysis preparation assembly 9 to achieve a predetermined potassium concentration value in the mixed solution of the dialysis fluid, wherein the potassium concentration value can be assumed based on the control of the concentrate pumps 29 and 30 to deliver solutions of different potassium concentrations. The desired potassium concentration value can be set constant during the blood treatment period; alternatively, the desired potassium concentration value can be variable during the blood treatment period according to a predetermined potassium profile.

[0278] In more detail, a potassium profile may mean that the potassium concentration decreases over time, for example according to the following formula:

[0279] Among them, T delay <t<T dialysis

[0280] in:

[0281] K(t) is the actual value of potassium concentration in the mixed solution of the dialysis fluid;

[0282] K ini is the initial value of potassium concentration in the mixed solution of the dialysis fluid;

[0283] K F is the final value of potassium concentration in the mixed solution of dialysis fluid;

[0284] T delay is the initial time delay in the initiation of potassium delivery;

[0285] T dialysis is the length of blood processing;

[0286] t is the current processing time.

[0287] At the beginning of the blood treatment period until t = T delay , the potassium concentration value is set to a constant, equal to K ini .

[0288] The concentrate sources 27, 28 may be disposable plastic containers or bags containing the respective concentrates in liquid form: according to an embodiment in which a potassium profile is provided, the dialysis fluid preparation assembly 9 may comprise a Baxter KV93G and KV95G.

[0289] The second operating condition is advantageously used in cases where only one formulation for the dialysis fluid and any possible infusion fluid is required. This is the case for typical chronic treatments of HD, HF and HDF. In this configuration, Figure 2 As shown, the concentrate container 103 still contains a buffer such as sodium bicarbonate (optionally in powdered / dry form). In this case, the concentrate container 103 from Baxter can be used again. A second concentrate A containing electrolytes is then used, for example from Baxter or SelectBag In this embodiment, purified water is first mixed with sodium bicarbonate and then the buffer containing fluid is mixed with the electrolytes contained in the first bag 27 and / or the second bag 28 to produce a suitable dialysis fluid. Figure 2 and Figure 3 The hydraulic circuit schematically shown in FIG, therefore the same configuration will be correctly configured and suitable for providing standard dialysis online treatment and providing AFB and AFBK online treatment. As already mentioned, the described embodiments are intended to be non-limiting examples. In particular, Figure 1 The circuit should not be interpreted as limiting or restrictive, as devices such as those in the present invention may include other components in addition to or in place of those described. For example, an ultrafiltration line with at least one corresponding pump connected to the dialysis effluent line 13 may be included. Figure 4 The blood circuit is intended for double needle treatment: however, this is a non-limiting example of a blood set. In practice, the device can be configured to perform single needle treatment, i.e. the patient is connected to the extracorporeal blood circuit via a single needle and the extracorporeal line from the patient is then divided into an extraction line and a return line using, for example, a "Y" connector. During single needle treatment, a blood extraction phase in which blood is removed from the patient alternates with a blood return phase in which the blood is returned to the patient. In addition, one or more devices for measuring the concentration of substances can be implemented in either (or both) the dialysis fluid side or (and) the blood side of the hydraulic circuit. It may be necessary to know the concentration of calcium, potassium, magnesium, bicarbonate and / or sodium. Finally, the one or more pumps mentioned above and all other temperature sensors, pressure sensors and concentration sensors can be operated on the dialysis fluid supply line 8 and / or the dialysis effluent line 13 in order to adequately monitor the preparation and movement of liquid in the hydraulic circuit.

Claims

1. A device for extracorporeal blood treatment (1), comprising: - a filter unit (2), said filter unit (2) having a main chamber (3) and a secondary chamber (4), said main chamber (3) and said secondary chamber (4) being separated by a semipermeable membrane (5); - a blood circuit (17), said blood circuit (17) comprising at least: a blood extraction line (6) extending between a first end connected to an inlet of the main chamber and a second end for connection to a patient (P); and a blood return line (7) extending between a first end connected to the outlet of the main chamber (3) and a second end for connection to the patient (P); - a fluid circuit (32), said fluid circuit (32) comprising at least: ● one or more water inlet pipes (14a) for receiving water; a dialysis preparation assembly (9), the dialysis preparation assembly (9) comprising one or more concentrate sources (27, 28) and configured to prepare a mixed solution of dialysis fluid, the one or more concentrate sources (27, 28) containing corresponding concentrate solutions, at least one of the one or more water inlet pipes (14a) being configured to supply water to the dialysis preparation assembly (9) for preparing the mixed solution of dialysis fluid, an infusion preparation assembly (108), which is separate from and distinct from the dialysis preparation assembly (9), comprises one or more concentrate sources (102) and is configured to prepare a mixed solution of infusion fluids, wherein the one or more concentrate sources (102) contain corresponding concentrate solutions (103), and at least one of the one or more water inlet tubes (14a) is configurable to provide water to the infusion preparation assembly (108) for preparing the mixed solution of infusion fluids, - a supply line (8) extending between the outlet of the dialysis preparation assembly (9) and the inlet of the secondary chamber (4) of the filtration unit (2); an infusion line (109) extending between an outlet of the infusion preparation set (108) and an infusion access point (19) of the blood circuit (17), a shut-off element arranged at least on the fluid circuit (32) and operable at least on the fluid circuit (32), and configured to move between a closed position, in which the fluid passage is blocked, and an open position, in which the fluid passage is allowed; a control unit (12) configured to control one or more of the shut-off elements between the closed position and the open position to determine a fluid flow configuration defined according to a fluid path, the fluid flow configuration comprising at least a main operating mode, wherein: At least one of the one or more water inlet pipes (14a) is configured to provide water to the dialysis preparation assembly (9) for preparing the mixed solution of the dialysis fluid, and The mixed solution of the dialysis fluid can be supplied to the inlet of the secondary chamber (4) of the filtration unit (2), and At least one of the one or more water inlet tubes (14a) is configured to provide water to the infusion preparation assembly (108) for preparing a mixed solution of the infusion fluid, and the mixed solution of the infusion fluid can be infused into the blood circuit (17) through the infusion access point (19), The outlet of the dialysis preparation assembly (9) is fluidly connected to the inlet of the secondary chamber (4) of the filtration unit (2), and The outlet of the infusion preparation set (108) is fluidly connected to the blood circuit (17), The one or more water inlet pipes (14a) are configured to independently supply water and directly supply the water to both the dialysis preparation component (9) and the infusion preparation component (108) through different pipe sections; The control unit (12) is configured to control the dialysis preparation component (9) and the infusion preparation component (108) to prepare the mixed solution of the dialysis fluid and the mixed solution of the infusion fluid, respectively, so that the mixed solution of the dialysis fluid and the mixed solution of the infusion fluid have different components, and the dialysis fluid and the infusion fluid are different due to the following items: o the nature of the solute or solutes; and / or o the concentration of the one or more solutes; And, while the mixed solution of the infusion fluid is infused into the blood circuit (17), the mixed solution of the dialysis fluid is supplied to the inlet of the secondary chamber (4) of the filtration unit (2).

2. The device according to claim 1, wherein The fluid flow configuration also includes a second mode of operation, wherein: - the mixed solution of infusion fluid and the mixed solution of dialysis fluid are mixed so as to define an auxiliary mixed solution of dialysis fluid flowing in the supply line (8); - the auxiliary mixed solution of the dialysis fluid can be supplied to the inlet of the secondary chamber (4) of the filtration unit (2) and / or can be infused into the blood circuit (17), The dialysis preparation assembly (9) is fluidly connected in series upstream or downstream relative to the infusion preparation assembly (108), The dialysis preparation assembly (9) is fluidly connected downstream to the infusion preparation assembly (108).

3. The device according to claim 1, wherein The one or more concentrate sources (27, 28) of the dialysis preparation assembly (9) include at least one concentrate selected from the group consisting of sodium chloride, calcium chloride, magnesium chloride, and potassium chloride.

4. The device according to claim 1, wherein In the primary operating mode, one of the one or more concentrate sources (27, 28) of the dialysis preparation assembly (9) comprises concentrated electrolytes including sodium, calcium and potassium, Another of the one or more concentrate sources (27, 28) of the dialysis preparation assembly (9) comprises concentrated electrolytes including sodium and calcium.

5. The device according to claim 4, wherein The potassium concentration in one of the one or more concentrated sources (27, 28) is different from the potassium concentration in the other of the one or more concentrated sources (27, 28); and wherein the concentration of electrolytes other than potassium is equal in one of the one or more concentrated sources (27, 28) and in the other of the one or more concentrated sources (27, 28).

6. The device according to claim 1, wherein At least one concentrated solution (103) contained in the one or more concentrated sources (102) of the infusion preparation component (108) includes a buffer substance from the group consisting of bicarbonate, citrate, lactate and acetate; wherein, in the main operating mode, the at least one concentrated solution (103) includes sodium bicarbonate; the at least one concentrated solution (103) is contained in the one or more concentrated sources (102) of the infusion preparation component (108).

7. The device according to any one of claims 1 to 6, comprising: a first conductivity sensor (35) arranged in the dialysis preparation assembly (9) on a first preparation line (9a) downstream relative to the one or more concentrate sources (27, 28) and configured to provide a signal representing the conductivity of the mixed solution of the dialysis fluid, wherein the control unit (12) is configured to receive the signal representing the conductivity, determine an actual conductivity and compare the actual conductivity with a target conductivity, and to drive the dialysis preparation assembly (9) to reduce the difference between the actual conductivity and the target conductivity; and - a second conductivity sensor (104) arranged in the infusion preparation assembly (108) on a second preparation line (108a) downstream of one or more concentrate sources (102) of the infusion preparation assembly (108) and configured to provide a signal representing the conductivity of the mixed solution of the infusion fluid, wherein the control unit (12) is configured to receive the signal representing the conductivity to determine an actual conductivity and to compare the actual conductivity with a target conductivity, the control unit driving the infusion preparation assembly (108) to reduce a difference between the actual conductivity and the target conductivity.

8. The apparatus according to claim 7, wherein the first conductivity sensor (35) is configured to provide a signal representing the conductivity of the auxiliary mixed solution of the dialysis fluid.

9. The device according to any one of claims 1 to 6, wherein: The fluid circuit (32) comprises a bridge line (110) which is inserted in the fluid connection between the infusion line (109) and the supply line (8), Wherein, the shut-off element comprises: a bridge valve (110a) arranged on the bridge line (110) to allow or block the flow of fluid between the infusion line (109) and the supply line (8); and / or - an infusion valve (109a) arranged on the infusion line (109) to allow or prevent the flow of infusion fluid towards the access point (19); and / or a first inlet valve (34) arranged on a first preparation line (9a), said inlet valve being interposed between said water inlet pipe (14a) and said one or more concentrate sources (27, 28) of said dialysis preparation assembly (9); and / or a second inlet valve (100a) arranged on a second preparation line (108a), said inlet valve being interposed between the water inlet pipe (14a) and the one or more concentrate sources (102) of the infusion preparation assembly (108).

10. The device according to claim 9, wherein In the main operating mode: The first inlet valve (34) of the first preparation line (9a) and the second inlet valve (100a) of the second preparation line (108a) are in open positions; ● The bridge valve (110a) is in the closed position; A dialysis fluid pump (25) determines the flow of dialysis fluid towards the secondary chamber (4) of the filtration unit (2); the infusion pump (106) of the infusion line (109) determines the flow of infusion fluid towards the access point (19) of the blood circuit (17) or directly in the patient's vascular access, and / or wherein, in the second operating mode: The first inlet valve (34) of the first preparation line (9a) is in the closed position; The second inlet valve (100a) of the second preparation line (108a) is in an open position; ● The bridge valve (110a) is in the open position; The dialysis fluid pump (25) determines the flow of dialysis fluid towards the secondary chamber (4) of the filtration unit (2); • The infusion pump (106) of the infusion line (109) is not activated.

11. The device according to any one of claims 1 to 6, wherein The fluid circuit (32) comprises: a water inlet pipe (14a) for receiving water, said water inlet pipe (14a) branching into a water line (100) for feeding water directly to the infusion preparation assembly (108), and into a water branch (113) for feeding water directly to the dialysis preparation assembly (9), wherein the shut-off element comprises one or more valves (100a, 34) for allowing or preventing the water from flowing in the water line (100) and / or the water branch (113), a bridge line (110) fluidically connecting the outlet of the infusion preparation set (108) with the inlet of the dialysis preparation set (9), wherein the shut-off element comprises one or more valves (110a) to allow or prevent water from flowing in the bridge line (110), an infusion line (109) connected to the outlet of the infusion preparation set (108) for conveying the infusion fluid to the blood circuit (17), the infusion line comprising an online port (115) and a tubing portion connecting the outlet of the infusion preparation set (108) to the online port (115), wherein the tubing portion connecting the outlet of the infusion preparation set (108) to the online port (115) comprises an infusion pump (106), - a supply line (8) connected to the outlet of the dialysis preparation assembly (9) and conveying the infusion fluid to the filtration unit (2), a connecting line (114) fluidly connecting the infusion line (109) and the supply line (8), wherein the shut-off element comprises one or more valves (114a, 114b) to allow or prevent fluid flow in the connecting line (114).

12. The device according to claim 11, wherein In the main operating mode, the control unit (12) drives: the one or more valves (100a, 34) to allow water to flow through the water branch (113) towards the dialysis preparation assembly (9) and through the water line (100) towards the infusion preparation assembly (108), The one or more valves (110a) are configured to prevent fluid flow between the outlet of the infusion preparation assembly (108) and the inlet of the dialysis preparation assembly (9) through the bridge line (110), The one or more valves (114a, 114b) in the connecting line (114) are configured to prevent fluid flow between the infusion line (109) and the supply line (8) through the connecting line (114).

13. The device according to claim 11, wherein The tubing portion connecting the outlet of the infusion preparation set (108) to the inline port (115) comprises at least one infusion ultrafilter (107).

14. The device according to claim 13, wherein the infusion ultrafilter (107) is placed between a connecting line (114) and the online port (115), the connecting line (114) fluidly connecting the tube portion to the outlet of the dialysis preparation assembly (9).

15. The device according to claim 13, wherein The inline port (115) is an inlet placed on an external portion of the cabinet of the device, and is configured for connecting a disposable tube that guides fluid to the blood circuit (17).

16. The device according to any one of claims 1 to 6, wherein The fluid circuit (32) includes a junction tube (116) which fluidically connects the supply line (8) to the infusion line (109) downstream of an infusion pump (106) placed on the infusion line (109), and the shut-off element includes one or more valves (116a) to allow or prevent fluid from flowing in the junction tube (116), wherein, in the main operating mode, the control unit (12) drives the one or more valves (116a) to prevent fluid flow between the infusion line (109) and the supply line (8) through the junction tube (116).

17. The device of claim 16, the junction tube (116) connecting the supply line (8) to an inline port (115) of the infusion line (109).

18. The device according to any one of claims 1 to 6, wherein The fluid circuit (32) comprises a water inlet pipe (14a) for receiving water, the water inlet pipe (14a) branches into a water line (100) for feeding water directly to the infusion preparation component (108), and branches into a water branch (113) for feeding water directly to the dialysis preparation component (9), wherein the fluid circuit (32) comprises an inlet flow meter (49) placed on the water inlet pipe (14a) upstream of the branch and an effluent line flow meter (42) on the effluent line (13), wherein, at least in the main operating mode, the control unit (12) is configured to: - receiving or calculating a set ultrafiltration rate to be achieved during said extracorporeal blood treatment; and - Based on the signals received from the inlet flow meter (49) and the effluent line flow meter (42), the device is driven to achieve the set ultrafiltration rate based on the difference between the effluent flow measured by the effluent line flow meter (42) and the sum of the infusion flow and the dialysis flow measured by the inlet flow meter (49).

19. The device according to any one of claims 1 to 6, wherein The fluid circuit (32) comprises a supply line flow meter (41) on the supply line (8), an infusion line flow meter (105) on the infusion line (109) and an effluent line flow meter (42) on the effluent line (13), wherein, in the main operating mode, the control unit (12) receives signals from the supply line flow meter (41), the infusion line flow meter (105) and the effluent line flow meter (42) to control the ultrafiltration rate through the dialyzer, wherein the control unit (12) receives or calculates a set ultrafiltration rate to be achieved during extracorporeal blood treatment and, based on the signals received from the supply line flow meter (41), the infusion line flow meter (105) and the effluent line flow meter (42), drives the device to achieve the set ultrafiltration rate based on the difference between the effluent flow and the sum of the dialysis flow and the infusion flow measured by the infusion line flow meter (105).

20. The device according to any one of claims 1 to 6, wherein The control unit (12) is configured to control one or more of the shut-off elements between an open position and a closed position to allow or prevent fluid communication between the infusion line (109) and the supply line (8).

21. The device according to any one of claims 1 to 6, wherein The fluid circuit (32) defines a fluid line network including the dialysis preparation assembly (9), the infusion preparation assembly (108), the infusion line (109), the supply line (8) and the shut-off element, The dialysis preparation component (9), the infusion preparation component (108), the infusion line (109) and the supply line (8) are interconnected via the fluid line network and can be fluidically connected to one another based on the open position or closed position of the shut-off element.

22. The device according to any one of claims 1 to 6, wherein The control unit (12) is configured to control one or more of the shut-off elements between an open position and a closed position to allow or prevent the dialysis preparation component (9) from being fluidically connected to the infusion preparation component (108), to allow or prevent the mixed solution of the dialysis fluid prepared in the dialysis preparation component (9) from being fluidically connected to the infusion preparation component (108), or to allow the mixed solution of the infusion fluid prepared in the infusion preparation component (108) to be fluidically connected to the dialysis preparation component (9).

23. The device according to any one of claims 1 to 6, wherein The dialysis preparation assembly (9) and the infusion preparation assembly (108) are interconnected by fluid lines, which define a fluid line network including the shut-off elements, and the control unit (12) is configured to control one or more of the shut-off elements between an open position and a closed position to define two or more fluid paths for the mixed solution of the dialysis fluid and the mixed solution of the infusion fluid.

24. The device according to claim 23, wherein The two or more fluid paths include at least one fluid path in which the mixed solution of the dialysis fluid prepared by the dialysis preparation component (9) is not mixed with the mixed solution of the infusion fluid prepared by the infusion preparation component (108), and another fluid path in which any one of the following is selected: The fluid prepared by the dialysis preparation component (9) enters the infusion preparation component (108); The fluid prepared by the infusion preparation component (108) enters the dialysis preparation component (9); • The fluid prepared by the dialysis preparation assembly (9) is mixed with the fluid prepared by the infusion preparation assembly (108).

25. The device according to any one of claims 1 to 6, wherein The fluid flow configuration includes at least a second operating mode, wherein the dialysis preparation component (9) and the infusion preparation component (108) cooperate to prepare an auxiliary mixed solution of dialysis fluid that is different from the mixed solution of the dialysis fluid and the mixed solution of the infusion fluid.

26. The device according to any one of claims 1 to 6, wherein The fluid flow configuration comprises at least a second operating mode, wherein the control unit is configured to control the shut-off element to mix the mixed solution of dialysis fluid with the mixed solution of infusion fluid to define a secondary mixed solution of dialysis fluid.

27. The device according to any one of claims 1 to 6, wherein the infusion line extends between an outlet of an infusion preparation set (108) and an access point (19) placed at a blood return line (7) of a blood circuit (17), the outlet of the infusion preparation set (108) being fluidly connected to the blood return line (7) of the blood circuit (17).

28. An apparatus (1) for extracorporeal blood treatment, comprising: - a filter unit (2), said filter unit (2) having a main chamber (3) and a secondary chamber (4), said main chamber (3) and said secondary chamber (4) being separated by a semipermeable membrane (5); - a blood circuit (17), said blood circuit (17) comprising at least: a blood extraction line (6) extending between a first end connected to an inlet of the main chamber and a second end for connection to a patient (P); and a blood return line (7) extending between a first end connected to the outlet of the main chamber (3) and a second end for connection to the patient (P); - a fluid circuit (32), said fluid circuit (32) comprising at least: ● one or more water inlet pipes (14a) for receiving water; a dialysis preparation assembly (9), the dialysis preparation assembly (9) comprising one or more concentrate sources (27, 28) and configured to prepare a mixed solution of dialysis fluid, the one or more concentrate sources (27, 28) containing corresponding concentrate solutions, at least one of the one or more water inlet pipes (14a) being configured to supply water to the dialysis preparation assembly (9) for preparing the mixed solution of dialysis fluid, an infusion preparation assembly (108), separate and distinct from the dialysis preparation assembly (9), comprising one or more concentrate sources (102) and configured to prepare a mixed solution of infusion fluid, The one or more concentrate sources (102) contain corresponding concentrate solutions (103), and at least one of the one or more water inlet pipes (14a) can be configured to provide water to the infusion preparation component (108) for preparing the mixed solution of the infusion fluid. a shut-off element arranged at least on the fluid circuit (32) and operable at least on the fluid circuit (32), and configured to move between a closed position, in which the fluid passage is blocked, and an open position, in which the fluid passage is allowed; a control unit (12) configured to control one or more of the shut-off elements between the closed position and the open position to determine a fluid flow configuration defined according to a fluid path, the fluid flow configuration comprising at least a main operating mode, wherein: At least one of the one or more water inlet pipes (14a) is configured to provide water to the dialysis preparation assembly (9) for preparing the mixed solution of the dialysis fluid, and The mixed solution of the dialysis fluid can be supplied to the inlet of the secondary chamber (4) of the filtration unit (2), and At least one of the one or more water inlet tubes (14a) is configured to provide water to the infusion preparation assembly (108) for preparing a mixed solution of the infusion fluid, and the mixed solution of the infusion fluid can be infused into the blood circuit (17) through an infusion access point (19), and, wherein the fluid flow configuration further comprises a second mode of operation, wherein, - the mixed solution of the infusion fluid and the mixed solution of the dialysis fluid are mixed to define an auxiliary mixed solution of the dialysis fluid flowing in a supply line (8) extending between the outlet of the dialysis preparation assembly (9) and the inlet of the secondary chamber (4) of the filtration unit (2); - The auxiliary mixed solution of the dialysis fluid can be supplied to the inlet of the secondary chamber (4) of the filtration unit (2) and / or can be infused into the blood circuit (17).

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