Disposable circuits for extracorporeal blood treatment, devices for extracorporeal blood treatment, and related methods

Abstract

A disposable circuit for extracorporeal blood treatment comprising a filtration unit (2) and a blood circuit (6, 7) having a blood withdrawal line (6) and a blood withdrawal line (7), the blood withdrawal line (6) and the blood return line (7) designed to be connected to a patient's cardiovascular system, the blood withdrawal line (6) and the blood return line (7) comprising an arterial connector (40) and a venous connector (41) detachably connected to a vascular access device of the patient, at least one liquid line (15, 21, 25, 42, 42a) being connected to the blood circuit, the disposable circuit comprising a first auxiliary connector (51, 53, 55, 57, 59) and a second auxiliary connector (50, 52, 54, 56, 58) arranged either on the blood circuit (6, 7) or on the liquid line (15, 21, 25, 42, 42a) and configured to be detachably connected to the arterial connector (40) and the venous connector (41) to define a closed circuit allowing recirculation of liquids.

Description

[Technical Field]

[0001] The present disclosure relates to a disposable circuit for extracorporeal treatment of blood configurable for fluid recirculation, an apparatus for extracorporeal treatment of blood, a method for blood flow recirculation in a disposable circuit, and related computer program products.

[0002] The disposable circuit is particularly suitable for temporarily disconnecting a patient from an apparatus for extracorporeal treatment of blood and then reconnecting the patient to the same disposable circuit for continued treatment. [Background technology]

[0003] Extracorporeal blood processing involves removing blood from a patient, treating the blood outside the patient's body, and returning the treated blood to the patient. Extracorporeal blood processing is typically used to remove undesirable substances or molecules from a patient's blood and / or add desirable substances or molecules to the blood. Extracorporeal blood processing is used for patients who cannot effectively remove substances from their blood, such as when the patient suffers from temporary or permanent renal failure. These and other patients may undergo extracorporeal blood processing to, for example, add or remove substances from the blood, maintain acid / base balance, or remove excess fluid.

[0004] Extracorporeal blood processing is typically accomplished by transferring blood from a patient in a continuous flow, for example, by introducing blood into a primary chamber, also called a blood chamber, of a filtration unit (such as a dialyzer or hemofilter) that allows the blood to flow across a semipermeable membrane that selectively allows substances in the blood to pass through the membrane from the primary chamber to a secondary chamber and, depending on the type of processing, selectively allows substances in the secondary chamber to pass through the membrane to the blood in the primary chamber.

[0005] Many different types of extracorporeal blood treatments can be performed. In ultrafiltration (UF) treatments, undesirable substances are removed from the blood by convection across a membrane into a secondary chamber. In hemofiltration (HF) treatments, blood flows through a semipermeable membrane as in UF, and desirable substances are typically added to the blood by administering a fluid into the blood before and / or after the blood passes through the filtration unit and before the blood is returned to the patient. In hemodialysis (HD) treatments, a secondary fluid containing desirable substances is introduced into the secondary chamber of the filtration unit. Undesirable substances from the blood pass through the semipermeable membrane into the secondary fluid, and desirable substances from the secondary fluid can pass through the membrane into the blood. In hemodiafiltration (HDF) treatments, the blood and the secondary fluid exchange substances as in HD, and, further, substances are typically added to the blood by administering a fluid into the treated blood before the blood is returned to the patient as in HF.

[0006] Specific blood processing devices have been developed, primarily for the treatment of acute patients, because: In acute patients, the total treatment time is unknown in advance and therefore cannot be used as a setup parameter since it is unknown how long the renal failure will last; indeed, acute patients often require relatively long treatment sessions, typically lasting several days, before recovering from renal failure. Rather, the intensive care device may be designed to require multiple flow rate information as a setup parameter. - Acute patients require very precisely controlled fluid withdrawal, and furthermore, the infusion of drugs or fluids generally must also be very precisely controlled. Acute patients are also very weak and therefore it has been considered important in the course of treating acute patients to have very precise control over the flow rate in each line connected to the blood line to ensure continuous and gentle treatment to the patient during treatment. Furthermore, since the device often needs to be operated in an emergency, therefore, devices for acute treatment should be characterized by a very simple setup procedure.

[0007] Some patient treatments can involve lengthy procedures in which blood is treated over several days or even weeks, as is the case with continuous renal replacement therapy (CRRT), in which the blood treatment device can operate continuously for several days. Whether the treatment is for continuous renal replacement or for an acute or chronic patient, there may be cases in which the patient needs to be disconnected from the device before treatment is complete. This is the case, for example, when the patient must undergo a medical examination outside the renal unit room or when an intervention on the vascular access must be performed suddenly. Disconnecting and reconnecting the blood treatment device to the blood circuit lines requires disconnecting the patient from these lines, particularly the venous and arterial connectors located at the ends of the blood circuit device (e.g., the patient is disconnected from the respective venous and arterial needles inserted into the fistula—chronic treatment—or from the catheters fixed to the patient—acute treatment).

[0008] Such temporary disconnection is important for at least the following reasons: disconnection and reconnection of the blood circuit of a blood processing device must be performed under sterile conditions, which requires a qualified operator who cannot interact with the device's control unit, which is typically not sterile; stagnant blood in the device's blood circuit can clot, so the blood processing device must be left inoperative for a very short time so as not to compromise patient safety; on the other hand, complete replacement of the disposable circuit during a temporary interruption of treatment should be avoided at least for economic reasons; in this latter case, replacing the disposable circuit would imply significantly higher costs for each single treatment.

[0009] U.S. Patent No. 9,713,670 discloses a method for temporarily suspending extracorporeal treatment of a patient's blood using a blood treatment device. The method includes activating a control device configured to place the blood treatment device in a state in which the patient's blood treatment session can be suspended, with the intention of continuing the blood treatment session. The end of the blood line is disconnected from the patient and connected to the same saline bag via a "Y" connector. The fluid is then recirculated within the blood circuit.

[0010] U.S. Patent Application Publication No. 2009 / 221949 describes a device for isolating and treating a patient's partial circulation. A pump draws fluid from a venous reservoir to deliver it to a heater and oxygenator unit. The outlet of the oxygenator unit is connected to a first arterial Y-connector. The main stream outlet of the first arterial Y-connector is connected to the patient's arterial catheter via an arterial trunk conduit. On the venous side, blood or fluid coming from the patient via the venous catheter passes through a venous front conduit and the venous Y-connector. The shunt inlet of the venous Y-connector is connected to the shunt outlet of the first arterial Y-connector by means of a shunt conduit. The main stream outlet is connected to the venous reservoir by an integrated filter. A third port of the connector can deliver fluid to a collection bag 159.

[0011] U.S. Patent No. 6,913,588 shows an extracorporeal circuit connected in-line to an existing hemofiltration system. The hemofiltration system emerges from the patient's venous connection in a conduit equipped with a blood pump. Anticoagulants and substitution fluids are pumped into the conduit to prevent blood clotting and replace blood lost as waste. The blood enters the hemofilter, where ultrafiltrate is separated from the blood. After filtration, the blood exits the hemofilter through a shunt and conduit, along the blood line, and back into the patient's arterial system. The ultrafiltrate exits the hemofilter at the ultrafiltrate port through the ultrafiltrate conduit.

[0012] U.S. Patent No. 5,630,946 discloses a method for removing leukocytes from blood in an extracorporeal circuit by passing leukocyte containing blood from a patient into a container, passing a portion of the body fluid from the container through a recirculation loop including a filter assembly for removing leukocytes, and transferring a portion of the leukocyte-reduced blood into the container, wherein additional blood is mixed with the leukocyte-reduced blood in the container to provide a mixture, and then additional blood is transferred from the patient into the container so as to send a portion of the mixture to the patient while passing another portion of the mixture through the recirculation loop.

[0013] It is an object of embodiments of the present disclosure to provide a disposable circuit for extracorporeal treatment of blood that is particularly suitable for intensive care, but also for chronic treatment applications that facilitates quick and safe temporary disconnection of the patient from the device while blood treatment is being performed.

[0014] Furthermore, an object of embodiments of the present disclosure is a disposable circuit for extracorporeal treatment of blood that is economically convenient to use.

[0015] A further object of an embodiment of the present disclosure is a disposable circuit for extracorporeal treatment of blood that prevents errors in fluid management of fluids that remain stationary within the device while the patient is temporarily disconnected from the device.

[0016] A further object of an embodiment of the present disclosure is a disposable circuit for extracorporeal blood treatment that allows for safe reconnection of the patient to the device and safe reintroduction of fluid and / or blood still present in the device into the patient's circulatory system when the patient is reconnected to the treatment machine.

[0017] It is a further object of embodiments of the present disclosure to provide a disposable circuit that is configurable in a configuration that prevents stagnation and / or reduces the risk of clotting of blood still present therein when the patient is disconnected from the device. Summary of the Invention

[0018] At least one of the above objects is substantially achieved by a disposable circuit in the following manner.

[0019] A disposable circuit is disclosed according to the following aspects, which may be combined with each other in any combination where possible, and therefore the dependency of aspects is not intended to be strictly limiting.

[0020] According to a first aspect, a disposable circuit for extracorporeal treatment of blood is disclosed, comprising: a filtration unit (2), in particular having a primary chamber (3) and a secondary chamber (4) separated by a semipermeable membrane (5); a blood circuit (6, 7) comprising a blood removal line (6) having a first end connected to an inlet of the filtration unit (2), in particular to the primary chamber (3), and a blood return line (7) having a first end connected to an outlet of the filtration unit (2), in particular to the primary chamber (3), the blood removal line (6) and the blood return line (7) being designed to be connected to the cardiovascular system of a patient, a blood circuit (6, 7), wherein the blood removal line (6) has a second end provided with an arterial connector (40), and the blood return line (7) has a second end provided with a venous connector (41), the arterial connector (40) and the venous connector (41) being designed to be detachably connected to a vascular access device of a patient, the blood circuit being configured to interface with a blood pump (11) for controlling flow within the blood circuit (6, 7); optionally, a drain line (13) connected to the outlet of the secondary chamber (4); at least one fluid line (15, 21, 25, 42, 42a) connected to the blood circuit (6, 7), the disposable circuit further comprising at least one first auxiliary connector (51, 53, 55, 57, 59) disposed either on the blood circuit (6, 7) or on the at least one fluid line (15, 21, 25, 42, 42a), the at least one first auxiliary connector (51, 53, 55, 57, 59) configured to be removably connected to at least one connector between the arterial connector (40) and the venous connector (41) in a recirculation configuration to define a closed circuit allowing recirculation of fluid within the blood circuit; The disposable circuit optionally further comprises a second auxiliary connector (50, 52, 54, 56, 58) disposed on either the blood circuit or on the at least one fluid line (15, 21, 25, 42, 42a), the first auxiliary connector (51, 53, 55, 57, 59) and the second auxiliary connector (50, 52, 54, 56, 58) being configured to be removably connected to the arterial connector (40) on the one hand and the venous connector (41) on the other hand to define a closed circuit between the at least one fluid line (15, 21, 25, 42, 42a); Equipped with.

[0021] This first aspect is directed to, but is not limited to, devices for performing dialysis treatments, such as HF and HDF, and treatments involving regional anticoagulation therapy, or hemoperfusion treatments with fluid infusion. Additionally, this first aspect may also relate to configurations for ECC02R with infusion, i.e., the use of an oxygenator placed on the blood line to remove excess CO2 from the blood.

[0022] In accordance with another independent aspect, a disposable circuit for extracorporeal treatment of blood comprises: a filtration unit (2), a blood circuit (6, 7) comprising a blood removal line (6) having a first end connected to an inlet of the filtration unit (2) and a blood return line (7) having a first end connected to an outlet of the filtration unit (2), the blood removal line (6) and the blood return line (7) being designed to be connected to the cardiovascular system of a patient, a blood circuit (6, 7), wherein the blood removal line (6) has a second end provided with an arterial connector (40), and the blood return line (7) has a second end provided with a venous connector (41), the arterial connector (40) and the venous connector (41) being designed to be detachably connected to a vascular access device of a patient, the blood circuit being configured to interface with a blood pump (11) for controlling flow within the blood circuit (6, 7); at least one first auxiliary connector (51, 53, 55, 57, 59) arranged on the blood circuit (6, 7), the at least one first auxiliary connector (51, 53, 55, 57, 59) configured to be removably connected to at least one connector between the arterial connector (40) and the venous connector (41) in a recirculation configuration to define a closed circuit allowing recirculation of a liquid in the blood circuit; The disposable circuit optionally further comprises second auxiliary connectors (50, 52, 54, 56, 58) disposed on the blood circuit, wherein the first auxiliary connectors (51, 53, 55, 57, 59) and the second auxiliary connectors (50, 52, 54, 56, 58) are configured to be removably connected to the arterial connector (40) on the one hand and the venous connector (41) on the other hand so as to define a closed circuit; Equipped with.

[0023] This additional aspect is directed to, but is not limited to, devices for performing dialysis treatments without infusion into the blood circuit, such as HD, or hemoperfusion treatments without infusion. Furthermore, this further aspect may also relate to configurations for ECC02R without infusion, i.e., the use of an oxygenator placed on the blood line to remove excess CO2 from the blood.

[0024] According to a further aspect in accordance with the previous aspect, the disposable circuit includes a processing arrangement in which the arterial connector (40) and the venous connector (41) are detachably connected to a vascular access device of a patient, and blood can be drawn from the patient through the blood withdrawal line (6), circulated through the filtration unit (2), and returned to the patient through the blood return line (7); and one of the arterial connector (40) and the venous connector (41) is connected to a first auxiliary connector (51, 53, 55, 57, 59) and a second auxiliary connector (50). , 52, 54, 56, 58), and optionally the other of the arterial connector (40) and the venous connector (41) is removably connected to the other of the first auxiliary connector (51, 53, 55, 57, 59) and the second auxiliary connector (50, 52, 54, 56, 58), in which the liquid contained within the blood circuit (6, 7) can be recirculated within the disposable circuit.

[0025] According to a second aspect, which is in accordance with any one of the previous aspects, the first auxiliary connector (51, 53, 55, 57, 59), optionally both the first auxiliary connector (51, 53, 55, 57, 59) and the second auxiliary connector (50, 52, 54, 56, 58), comprises at least one detachable port (70, 70a) configured to correspond and connect to a detachable port (72) of either the venous connector (41) or the arterial connector (40).

[0026] A severable port refers to an inlet or outlet of a connector that allows for a removable connection with a corresponding severable port of another connector. A Luer lock design is one example of a severable connection, where one severable port of a first connector may be a tapered cone configured to slide over its mating tapered cavity of a second connector, and the other severable port of the second connector is a mating tapered cavity with an integrated locking thread.

[0027] According to a third aspect corresponding to the second aspect, at least one connector between the first auxiliary connector (51, 53, 55, 57, 59) and the second auxiliary connector (50, 52, 54, 56, 58), and optionally both the first auxiliary connector (51, 53, 55, 57, 59) and the second auxiliary connector (50, 52, 54, 56, 58) is a three-port connector having a detachable port (72), a venous connector (41) or a detachable port (70) configured to be connected to the arterial connector (40).

[0028] According to a fourth aspect corresponding to one or more of aspects 1-2, the first auxiliary connector (51, 53, 55, 57, 59) is a four-port connector comprising a first detachable port (70) and a second detachable port (70a) configured to be connected to respective detachable ports (72) of the venous connector (41) or the arterial connector (40), respectively.

[0029] According to a fifth aspect corresponding to any of the second, third or fourth aspects, at least one connector between the first auxiliary connector (51, 53, 55, 57, 59) and the second auxiliary connector (50, 52, 54, 56, 58), and optionally both the first auxiliary connector (51, 53, 55, 57, 59) and the second auxiliary connector (50, 52, 54, 56, 58), comprises: a first non-detachable service port (71) fixed to the tube section, optionally a first non-detachable service port (71) and a second non-detachable service port (71) fixed to each tube section; at least one detachable port (70); Equipped with.

[0030] According to a sixth aspect corresponding to the fourth aspect, the first auxiliary connector (51, 53, 55, 57, 59) comprises a first non-detachable service port (71) and a second non-detachable service port (71) fixed to the tubing portion, a first detachable port (70) and a second detachable port (70a), and the first non-detachable service port (71) and the second non-detachable service port (71) fixed to the respective tubing portion are configured to be non-detachably connected to the respective portion of the liquid line (15, 21, 25, 42, 42a) to which the first auxiliary connector is fixed.

[0031] According to a seventh aspect corresponding to one or more of aspects 1 to 2, at least one connector between the first auxiliary connector (51, 53, 55, 57, 59) and the second auxiliary connector (50, 52, 54, 56, 58) is an end connector provided with a detachable port (70) configured to detachably connect to the arterial connector (40) or the venous connector (41).

[0032] According to an eighth aspect, corresponding to aspects 2 to 7, at least the first auxiliary connector (51, 53, 55, 57, 59) or the second auxiliary connector (50, 52, 54, 56, 58) is a "Y" or "T" connector, and / or a Luer-type connector, and / or a self-sealing connector, in which at least its first detachable port (70) is configured to prevent fluid leakage upon detachment from another connector and to automatically open to allow fluid passage when connected to the venous connector (41) or the arterial connector (40).

[0033] According to a ninth aspect according to one or more of the preceding aspects, at least one detachable port (70, 70a) of at least one first auxiliary connector (51, 53, 55, 57, 59) and at least one detachable port (72) of the arterial connector (40) or the venous connector (41) may be either of a first male type or of a second female type, the first male type being configured to be at least partially introduced into the second female type; - both the arterial connector (40) and the venous connector (41) are connectors with a first type of detachable port (72), or alternatively Both the arterial connector (40) and the venous connector (41) are equipped with a second type of detachable port (72).

[0034] According to a tenth aspect corresponding to the ninth aspect, The first auxiliary connector (51, 53, 55, 57, 59) and the second auxiliary connector (50, 52, 54, 56, 58) have at least one detachable port (70) of either both male type or both female type.

[0035] According to an eleventh aspect, in accordance with one or more of the preceding aspects, one or more liquid lines (15, 21, 25, 42, 42a) are directly connected to the blood circuit, optionally via the interposition of a non-detachable connector, preferably a three-way integrated connector.

[0036] According to a twelfth aspect, in accordance with one or more of the preceding aspects, the one or more liquid lines (15, 21, 25, 42, 42a) are: a post-blood pump pre-dilution infusion line (15) connected directly to the blood removal line (6); - a pre-dilution pre-infusion line (21) connected directly to the blood removal line (6), - a post-dilution fluid line (25) connected directly to the blood return line (7), It comprises one or more of the following:

[0037] According to a thirteenth aspect, in accordance with one or more of the previous aspects, a first auxiliary connector (51, 53, 55, 57, 59) is arranged on the blood circuit (6, 7).

[0038] According to a fourteenth aspect in accordance with one or more of the previous aspects, the first auxiliary connector (51, 53, 55) is disposed on the blood removal line (6).

[0039] According to a fifteenth aspect corresponding to one or more of the previous aspects 1 to 13, the first auxiliary connector (57, 59) is disposed on the blood return line (7).

[0040] According to a sixteenth aspect corresponding to one or more of the previous aspects 1 to 12, the first auxiliary connector (51) is arranged on the post-blood pump pre-dilution infusion line (15).

[0041] According to a seventeenth aspect corresponding to one or more of the previous aspects 1 to 12, the first auxiliary connector (53) is arranged on the pre-blood pump pre-dilution infusion line (21).

[0042] According to an eighteenth aspect corresponding to one or more of the previous aspects 1 to 12, the first auxiliary connector (57) is arranged on the post-dilution liquid line (25).

[0043] According to a nineteenth aspect, in accordance with one or more of the previous aspects, a second auxiliary connector (50, 52, 54, 56, 58) is arranged on the blood circuit (6, 7).

[0044] According to a twentieth aspect, in accordance with one or more of the previous aspects, a second auxiliary connector (50, 52, 54, 58) is disposed on the blood removal line (6).

[0045] According to a twenty-first aspect, in accordance with one or more of the previous aspects, a second auxiliary connector (50, 52, 54, 56, 58) is arranged on the blood return line (7).

[0046] According to a 22nd aspect corresponding to one or more of the previous 1st to 18th aspects, the second auxiliary connector (50) is arranged on the post-blood pump pre-dilution infusion line (15).

[0047] According to a 23rd aspect corresponding to one or more of the previous 1st to 18th aspects, the second auxiliary connector (52) is arranged on the pre-blood pump pre-dilution infusion line (21).

[0048] According to a 24th aspect corresponding to one or more of the previous 1st to 18th aspects, the second auxiliary connector (56) is disposed on the post-dilution liquid line (25).

[0049] According to a 25th aspect corresponding to one or more of the previous aspects 1 to 12, the first auxiliary connector and the second auxiliary connector are disposed in a post-blood pump pre-dilution infusion line (15).

[0050] According to a 26th aspect corresponding to one or more of the previous aspects 1 to 12, the first auxiliary connector and the second auxiliary connector are arranged in the pre-blood pump pre-dilution infusion line (21).

[0051] According to a 27th aspect corresponding to one or more of the previous aspects 1 to 12, the first auxiliary connector and the second auxiliary connector are arranged in the post-dilution liquid line (25).

[0052] According to a further aspect according to one or more of the previous aspects 1 to 12, the first auxiliary connector and the second auxiliary connector are arranged on the blood circuit, for example, the first auxiliary connector on the blood withdrawal line and the second auxiliary connector on the blood recovery line, or alternatively, both auxiliary connectors are arranged on the blood withdrawal line (6).

[0053] According to a 28th aspect, in accordance with one or more of the previous aspects, at least one fluid line (15, 21, 25, 42, 42a) connected to the blood circuit comprises at least one auxiliary line (42, 42a).

[0054] According to a 29th aspect corresponding to one or more of the previous aspects 1 to 12, 28, the first auxiliary connector (55) is disposed on at least one auxiliary line (42, 42a).

[0055] According to a thirtieth aspect corresponding to one or more of the previous aspects 1 to 12, 28, 29, a second auxiliary connector (54) is disposed on at least one auxiliary line (42, 42a).

[0056] According to a 31st aspect corresponding to one or more of the previous aspects 28 to 30, the first auxiliary connector and the second auxiliary connector are mounted on the same single auxiliary line (42), which optionally has its own liquid pumping path in which the liquid pump operates, and optionally the first auxiliary connector and the second auxiliary connector are mounted one upstream with respect to the other.

[0057] According to a 32nd aspect corresponding to one or more of the previous aspects 1 to 31, a blood pumping path configured to be acted upon by a blood pump (11) comprises an inlet port and an outlet port, and a withdrawal line (6) comprises a first portion (6a) located upstream of the inlet port of the blood pumping path and downstream of the arterial connector (40), and a second portion located downstream of the outlet port of the blood pumping path and upstream of the inlet of the primary chamber (3).

[0058] According to a 33rd aspect corresponding to aspects 17 and 32, the first auxiliary connector (53) of the pre-blood pump pre-dilution injection line (21) has a port that is in direct fluid communication with the first part (6a) of the blood removal line (6).

[0059] According to a 34th aspect corresponding to aspect 33, the pre-dilution infusion line (21) before the blood pump is configured to enable administration of a liquid to the blood circuit downstream of the arterial connector (40), and the pre-dilution infusion line (21) optionally includes a container containing, for example, an anticoagulant solution (e.g., a citrate solution), and the pre-dilution infusion line (21) before the blood pump is connected to the container.

[0060] In a thirty-fifth aspect according to the thirty-fourth aspect, the liquid line is a first auxiliary line (42), optionally equipped with its own liquid pump; a second auxiliary line (42a), optionally equipped with its own liquid pump; Equipped with A first auxiliary connector is attached to the first auxiliary line (42), and a second auxiliary connector is attached to the second auxiliary line (42a).

[0061] According to a thirty-sixth aspect, in accordance with one or more of the previous aspects, the disposable circuit further comprises at least one first pressure drop valve or flow resistor (60) configured to equalize the liquid flow distribution during recirculation, the at least one first pressure drop valve or flow resistor (60) being arranged on the blood circuit or on the at least one liquid line (15, 21, 25, 42, 42a), the at least one first pressure drop valve or flow resistor (60) being configured to equalize the liquid flow resistance of each of the two connected branched tubing sections during recirculation.

[0062] According to a 37th aspect corresponding to aspect 36, at least one first pressure drop valve or flow resistor (60) is arranged in one of two connected branched tubing sections, and optionally the two connected branched tubing sections comprise at least one portion of a liquid line (15, 21, 25, 42, 42a) and at least one portion of a blood circuit (6, 7).

[0063] According to a 38th embodiment, which corresponds to embodiments 36 and 37, at least one first pressure drop valve or flow resistor (60) is mounted downstream of at least one of the first auxiliary connectors (51, 53, 55, 57, 59) and the second auxiliary connectors (50, 52, 54, 56, 58), and optionally, the at least one first pressure drop valve or flow resistor (60) is mounted downstream of the first auxiliary connectors (51, 53, 55, 57, 59) and downstream of the second auxiliary connectors (50, 52, 54, 56, 58) and in a portion of the liquid line that is directly connected to the inlet of the primary chamber (3), and preferably also directly connected to the outlet of the blood pump (11).

[0064] Downstream is intended here to refer to the direction of infusion fluid prior to the infusion of substitution fluid during therapy. Specifically, a first pressure drop valve or flow resistor (60) is disposed on the post-blood pump pre-dilution infusion line (15) downstream of the first and second auxiliary connectors (see FIG. 6).

[0065] According to a thirty-ninth aspect, in accordance with one or more of the previous aspects, at least one of the liquid lines (15, 21, 25, 42, 42a) is configured to be coupled to a flow regulation actuator, in particular a liquid pump (18, 22, 27) configured to regulate the flow of liquid in the respective liquid line.

[0066] According to a fortieth aspect in accordance with aspects 12 and 39, a post-blood pump pre-dilution infusion line (15) connected to the blood removal line (6) having a fluid pump tubing section configured to be coupled to at least one infusion pump (18) for regulating the flow of fluid through the pre-dilution fluid line (15); a post-dilution fluid line (25) connected to the blood return line, the post-dilution fluid line having a fluid pump tubing section configured to be coupled to at least one infusion pump (27) for regulating flow through the post-dilution fluid line; - a pre-blood pump, pre-dilution infusion line (21) connected to the blood removal line (6) having a fluid pump tubing section configured to be coupled to at least one pre-blood infusion pump (22) for regulating the flow through the pre-blood pump infusion line;

[0067] According to a forty-first aspect corresponding to the fortieth aspect, at least one connector between the first auxiliary connector (51, 53, 55, 57, 59) and the second auxiliary connector (50, 52, 54, 56, 58) is arranged downstream of the liquid pump tube section of each injection liquid line (15, 21, 25), specifically, the first auxiliary connector (51, 53, 55, 57, 59) and the second auxiliary connector (50, 52, 54, 56, 58) are arranged downstream of the liquid pump (18, 22, 27) of each liquid line (15, 21, 25).

[0068] According to a forty-second aspect according to one or more of the preceding aspects, the first auxiliary connector (51, 53, 55, 57, 59) is connectable to the arterial connector (40) in particular through a direct connection between a port of the first auxiliary connector (51, 53, 55, 57, 59) and the arterial connector (40) or through a portion of a line connecting a port of the first auxiliary connector (51, 53, 55, 57, 59) and the arterial connector (40); The second auxiliary connectors (50, 52, 54, 56, 58) are connectable to the venous connector (41) specifically through a direct connection between the port of the second auxiliary connector (50, 52, 54, 56, 58) and the arterial connector (40) or through a portion of the line connecting the port of the second auxiliary connector (50, 52, 54, 56, 58) and the venous connector (41).

[0069] According to a forty-third aspect, which corresponds to one or more of the previous aspects, the disposable circuit comprises an air separator, in particular an air bubble trap (8), which is arranged downstream of the outlet of the primary chamber (3) in the part of the blood return line (7) between the outlet of the primary chamber (3) and the venous connector (41), and at least one of the liquid lines (15, 21, 25, 42, 42a), preferably all of the liquid lines (15, 21, 25, 42, 42a), connects to the blood circuit (6, 7) upstream of or at the air separator, i.e. between the arterial connector (40) and the air separator.

[0070] According to a forty-fourth aspect, in accordance with one or more of the previous aspects, the circuit further comprises a safety clamp (9) configured to operate on the blood return line (7) and to be controlled by the control unit (10), and at least one liquid line (15, 21, 25, 42, 42a) is arranged upstream of the safety clamp (9), and optionally all liquid lines (15, 21, 25, 42, 42a) are arranged upstream of the safety clamp (9) between the arterial connector (40) and the safety clamp (9).

[0071] According to a 45th aspect corresponding to the 44th aspect, at least one connector between the first auxiliary connector (51, 53, 55, 57, 59) and the second auxiliary connector (50, 52, 54, 56, 58) is arranged upstream of the safety clamp (9), and optionally, both the first auxiliary connector (51, 53, 55, 57, 59) and the second auxiliary connector (50, 52, 54, 56, 58) are arranged upstream of the safety clamp (9).

[0072] According to a 46th embodiment corresponding to embodiments 42 and 44, at least one connector between the first auxiliary connector (51, 53, 55, 57, 59) and the second auxiliary connector (50, 52, 54, 56, 58) is arranged below the safety clamp (9) in a portion of the blood return line (7) comprised between the outlet of the primary chamber (3) and the venous connector (41), and optionally, the first auxiliary connector (51, 53, 55, 57, 59) is arranged upstream of the safety clamp (9) and the second auxiliary connector (50, 52, 54, 56, 58) is arranged downstream of the safety clamp (9).

[0073] According to a forty-seventh aspect corresponding to aspect twelfth, the disposable circuit further comprises at least one infusate container (16, 23, 26) connected to the inlet of the post-blood pump pre-dilution line (15), or the inlet of the post-dilution liquid line (25), or the inlet of the pre-blood pump dilution line (21), and optionally comprises a first infusate container (16) connected to the inlet of the post-blood pump pre-dilution line (15), a second infusate container (26) connected to the inlet of the post-dilution liquid line (25), and a third infusate container (23) connected to the inlet of the pre-blood pump pre-dilution infusion line (21).

[0074] According to a 48th aspect according to any of the previous aspects when according to aspect 43, the disposable circuit is interfaced with an air bubble sensor (8a) configured to detect the presence of one or more air bubbles in the blood circuit (6, 7), the air bubble sensor (8a) being configured to be operably connected to the control unit (10) and configured to send a predetermined signal to the control unit (10) when at least one or more air bubbles are detected in the blood circuit (6, 7).

[0075] According to a forty-ninth aspect, corresponding to the forty-fourth and forty-eighth aspects, the bubble sensor (8a) is associated with the bubble trap (8) or is coupled to a portion of the blood return line (7) between the bubble trap (8) and the clamp (9); Specifically, the air bubble sensor (8a) is configured to send a predetermined signal to the control unit (10) when at least one air bubble is detected, so as to cause the clamp (9) to close.

[0076] According to a further aspect according to one or more of the previous aspects, the disposable circuit is a CRRT disposable circuit for use in an apparatus for extracorporeal treatment of blood in the acute field.

[0077] According to a further aspect according to one or more of the previous aspects, the disposable circuit is a CRRT disposable circuit including a disposable dialysate line (19) permanently connected to the inlet of the secondary chamber (4) and a disposable effluent line (13) permanently connected to the outlet of the secondary chamber (4).

[0078] According to a 50th aspect, in accordance with one or more of the previous aspects, the disposable circuit further comprises a dialysate line (19) connected to the inlet of the secondary chamber (4).

[0079] According to a fifty-first aspect corresponding to the fifty-first aspect, the disposable circuit further comprises a dialysate container (20) provided at the end of the dialysate line (19) and configured to deliver a liquid contained therein to the inlet of the secondary chamber (4), Optionally, The disposable circuit further comprises a dialysate pumping path arranged on the dialysate line (19) and which, when the dialysate pump (17a) is operated, forces the supply of liquid from the dialysate container (20) to the inlet of the secondary chamber (4).

[0080] According to a 52nd aspect, corresponding to aspect 50 or 51, the apparatus further comprises an effluent container (14) provided at the end of the effluent line (13) and configured to collect liquid extracted from the outlet of the secondary chamber (4), The disposable circuit optionally further comprises a drain pump path disposed on the drain line (13) and having a drain pump (17) thereon to force the withdrawal of liquid from the outlet of the secondary chamber (4) into a drain container (14).

[0081] According to a 53rd embodiment corresponding to one or more of the preceding embodiments, in the recirculation configuration, liquid flows from the arterial connector (40) through the primary chamber (3) to the venous connector (41), or from the second end of the blood removal line (6) to the first end of the blood removal line (6) and from the first end of the blood return line (7) to the second end of the blood return line (7).

[0082] According to a 54th aspect corresponding to one or more of the preceding aspects, at least one infusion liquid line (15, 21, 25, 42, 42a) has a first end connected, in particular directly connected, to the blood circuit (6, 7) and a second end opposite the first end, the disposable circuit including a treatment configuration different from the recirculation configuration, in which extracorporeal blood treatment is performed, and in which treatment configuration liquid flows from the second end to the first end in the at least one infusion liquid line (15, 21, 25, 42, 42a).

[0083] According to a 55th embodiment corresponding to embodiments 12 and 16, in the recirculation configuration, a first auxiliary connector (51) arranged on the post-blood pump pre-dilution infusion line (15) is connected to the venous connector (41), and a second auxiliary connector (50) arranged on the post-blood pump pre-dilution infusion line (15) is connected to the arterial connector (40).

[0084] According to a 56th aspect corresponding to aspects 12 and 16, in a recirculation configuration, a first auxiliary connector (51) arranged on the post-blood pump pre-dilution infusion line (15) is connected to the arterial connector (40), and a second auxiliary connector (50) arranged on the post-blood pump pre-dilution infusion line (15) is connected to the venous connector (41).

[0085] According to a 57th aspect corresponding to aspects 12 and 17, in a recirculation configuration, a first auxiliary connector (53) arranged on the pre-blood pump pre-dilution injection line (21) is connected to the arterial connector (40), and a second auxiliary connector (50) arranged on the pre-blood pump pre-dilution injection line (21) is connected to the venous connector (41).

[0086] According to a 58th embodiment corresponding to embodiments 12 and 17, in the recirculation configuration, a first auxiliary connector (53) arranged on the pre-blood pump pre-dilution injection line (21) is connected to the venous connector (41), and a second auxiliary connector (50) arranged on the pre-blood pump pre-dilution injection line (21) is connected to the arterial connector (40).

[0087] According to a 59th embodiment corresponding to embodiments 12 and 18, in the recirculation configuration, a first auxiliary connector (57) arranged on the dilution liquid line (25) is connected to the arterial connector (40), and a second auxiliary connector (56) arranged on the dilution liquid line (25) is connected to the venous connector (41).

[0088] According to a 60th embodiment corresponding to embodiments 12 and 18, in the recirculation configuration, a first auxiliary connector (57) arranged on the dilution liquid line (25) is connected to the venous connector (41), and a second auxiliary connector (56) arranged on the dilution liquid line (25) is connected to the arterial connector (40).

[0089] According to a 61st embodiment corresponding to embodiments 12, 15 and 20 or 21, in the recirculation configuration, a first auxiliary connector (59) arranged on the blood circuit (6, 7), specifically on the blood return line (7), is connected to the arterial connector (40), and a second auxiliary connector (58) arranged on the blood circuit (6, 7), specifically on the blood removal line (6), is connected to the venous connector (41).

[0090] According to a sixty-second embodiment, which is in accordance with embodiments 12 and 59 or embodiments 12 and 60, at least one first pressure drop valve or flow resistor (60) is disposed on the diluted liquid line (25).

[0091] According to a sixty-third embodiment corresponding to embodiments 12 and 55 or embodiments 12 and 56, at least one first pressure drop valve or flow resistor (60) is arranged on the post-blood pump pre-dilution infusion line (15).

[0092] According to two aspects of the sixty-third embodiment corresponding to aspects 12 and 57 or aspects 12 and 58, at least one first pressure drop valve or flow resistor (60) is arranged on the pre-blood pump pre-dilution injection line (21).

[0093] According to a sixty-fourth aspect, in accordance with one or more of the previous aspects, the disposable circuit comprises at least one sensor for determining a flow rate of a liquid (eg, blood) in at least the blood circuit (6, 7).

[0094] According to a further aspect according to one or more of the previous aspects, the first auxiliary connector and the second auxiliary connector are separate connectors. Alternatively, the first auxiliary connector and the second auxiliary connector may be made as a single part (e.g., a connector having four ways, two for permanently connecting to respective tube sections and two for connecting to the first auxiliary connector and the second auxiliary connector, respectively).

[0095] In a sixty-fifth aspect, the present invention discloses the use of a disposable circuit according to one or more of the aspects 1 to 64 in a device for extracorporeal treatment of blood for chronic patients.

[0096] In a sixty-sixth aspect, the present invention discloses the use of a disposable circuit according to one or more of the preceding claims in a device for extracorporeal treatment of blood for acute patients.

[0097] In a 67th aspect, the present invention discloses an apparatus for extracorporeal treatment of blood comprising a disposable circuit according to one or more of aspects 1 to 64, wherein the apparatus further comprises a blood pump (11) configured to at least control the flow of blood in the blood circuit (6, 7).

[0098] In a sixty-seventh aspect, there is provided a device comprising a disposable circuit according to one or more of aspects 1 to 64, the device further comprising a control unit (10) and a blood pump (11) configured to control the flow of blood in the blood circuit (6, 7); The control unit - stopping the blood pump (11) before disconnecting the patient, - receiving a command to activate the recirculation of the liquid in the blood circuit (6, 7); - when the disposable circuit is in a recirculation configuration, operating at least the blood pump (11) to recirculate the liquid in the blood circuit (6, 7); It is configured as follows.

[0099] According to a 68th aspect, corresponding to the 67th aspect, the device further comprises at least one flow regulation actuator, in particular a liquid pump (18, 22, 27) for at least one of the infusion lines (15, 21, 25), and optionally one or more of the following lines: a post-blood pump pre-dilution infusion line (15) connected to the blood removal line (6), wherein the device comprises at least one infusion pump (18) for regulating the flow of liquid through the post-blood pump pre-dilution infusion line (15); a post-dilution fluid line (25) connected to the blood return line, wherein the device comprises at least one infusion pump (27) for regulating the flow through the post-dilution fluid line (25); a pre-blood pump pre-dilution infusion line (21) connected to the blood withdrawal line (6), wherein the device comprises at least one pre-blood pump pre-dilution infusion pump (22) for regulating the flow through the pre-blood pump pre-dilution infusion line (21); exists.

[0100] According to a sixty-eighth aspect corresponding to the sixty-seventh aspect, in the recirculation configuration, the first auxiliary connector (51, 53, 55, 57, 59) is directly connected to either the arterial connector (40) or the venous connector (41), and the second auxiliary connector (50, 52, 54, 56, 58) is directly connected to the other of the arterial connector (40) and the venous connector (41), and the control unit (10) is configured to maintain the disposable circuit in the recirculation configuration. and during recirculation, either the total flow rate of liquid entering the first auxiliary connector (51, 53, 55, 57, 59) or the second auxiliary connector (50, 52, 54, 56, 58) is divided into separate partial flow rates, or two partial flow rates of liquid entering the first auxiliary connector (51, 53, 55, 57, 59) or the second auxiliary connector (50, 52, 54, 56, 58) are combined and exit as a total flow rate.

[0101] According to a 69th aspect corresponding to aspect 67 or 68, at least one of the blood pump (11), the infusion pump (18) of the post-blood pump pre-dilution infusion line (15), the infusion pump (27) of the post-dilution liquid line (25), the pre-blood infusion pump (22) of the post-blood pump pre-dilution infusion line (21), the dialysis pump (21), and the effluent pump (17) is a peristaltic pump fixedly mounted to the device, the actuator of which is configured to directly act, in particular to force the movement of the liquid through compression on the pump path of the respective line.

[0102] According to one or more of aspects 67 to 69 and a 70th aspect according to aspect 47, the device comprises at least one scale selected from the group consisting of: a first scale (34) operative to provide weight information for the amount of liquid dispensed from the first liquid container (16); a second scale (36) operative to provide weight information for the amount of liquid dispensed from the second liquid container (23); a third scale (37) operative to provide weight information relative to the amount of liquid dispensed from the third liquid container (26); a discharge scale (33) operative to provide weight information for the amount of liquid collected in the discharge container (14); a dialysis scale (20) operative to provide weight information for the amount of fluid delivered by the dialysate container (20); Further provided are:

[0103] According to a 71st aspect corresponding to one or more of the 67th to 70th aspects, the device further comprises a control unit (10) having at least one first operating configuration of the blood, the first operating configuration of the blood being: - the flow rate of the liquid through the discharge line (13) (Q eff ), the flow rate of the liquid through at least one inlet liquid line (15, 21, 25, 42, 42a) (Q pre , Q pbp , Q post ), optionally the flow rate (Q) of fluid through the post-blood pump pre-dilution infusion line (15), the pre-blood pump pre-dilution infusion line (21), the post-dilution fluid line (25), and the dialysate fluid line (19). dial ), the rate of fluid withdrawal from the patient (Q pfr ), blood flow (Q b receiving or calculating a flow rate of one or more liquids selected from the group comprising: It is configured as follows.

[0104] According to a 72nd aspect corresponding to aspect 71, the control unit (10) is configured to operate at least one of the blood pump (11), the infusion pump (18) of the post-blood pump pre-dilution infusion line (15), the infusion pump (27) of the post-dilution fluid line (25), the pre-blood infusion pump (22) of the pre-blood pump pre-dilution infusion line (21), the dialysis pump (17a), and the effluent pump (17) to deliver a predetermined or calculated flow rate.

[0105] According to a 73rd aspect in accordance with aspects 71 or 72 and 68, the control unit (10) - receiving a command to activate the temporary recirculation of the liquid in the blood circuit (6, 7); - setting at least one value of the flow rate of recirculation through the blood circuit (6, 7), - when in the recirculation configuration, actuating at least the blood pump (11) to recirculate the liquid in the blood circuit (6, 7); a second operating configuration including: The second operating configuration is performed after the first operating configuration has been interrupted and the flow rate of the liquid in the blood circuit (6, 7) has been reduced to zero, at least momentarily, by stopping at least the blood pump (11), optionally the blood pump (11), the infusion pump (18) of the pre-dilution liquid line (15), the infusion pump (27) of the post-dilution liquid line (25) and the pre-blood infusion pump (22) of the pre-blood pump infusion line (21).

[0106] According to a 74th aspect corresponding to one or more of the 71st to 73rd aspects, the control unit (10) is configured to obtain electronic confirmation of disconnection of the arterial connector (40) and the venous connector (41) before enabling operation of the blood pump (11) for recirculation.

[0107] According to a 75th aspect corresponding to one or more of aspects 63 to 74, the device further comprises a safety clamp (9) fixedly arranged on the blood circuit (6, 7), the safety clamp (9) having at least one open configuration that allows the flow of liquid through the blood circuit (6, 7) and a closed configuration that stops the flow of liquid through the blood circuit (6, 7), and optionally the safety clamp (9) is an electronically controlled safety clamp (9).

[0108] According to a 76th aspect, which corresponds to one or more of aspects 72, 73, 74 when combined with aspect 75, the safety clamp (9) is operably connected to the control unit (10), and in the first operating configuration and the second operating configuration, the safety clamp (9) receives a control signal that causes persistence of its open configuration, or when in the open configuration and switching between the first operating configuration and the second operating configuration, the safety clamp (9) receives a control signal that configures it to a closed configuration.

[0109] According to a seventy-seventh aspect in accordance with any of the previous aspects, in the operating / treatment configuration, at least one first auxiliary connector (51, 53, 55, 57, 59), optionally the first auxiliary connector (51, 53, 55, 57, 59) and the second auxiliary connector (50, 52, 54, 56, 58) are not connected to the arterial connector (40) and the venous connector (41), and in a recirculation configuration instead of the operating / treatment configuration, at least one second auxiliary connector (51, 53, 55, 57, 59) is connected to the arterial connector (40) and the venous connector (41). One auxiliary connector (51, 53, 55, 57, 59) is connected to the arterial connector (40) or the venous connector (41), and optionally, the first auxiliary connector (51, 53, 55, 57, 59) is connected directly to one connector between the arterial connector (40) and the venous connector (41), and the second auxiliary connector (50, 52, 54, 56, 58) is connected directly to the other connector between the arterial connector (40) and the venous connector (41).

[0110] According to a 78th embodiment according to embodiment 68 and any embodiment corresponding thereto, at least the blood pump (11), or the infusion pump (18) of the pre-blood pump dilution infusion line (15), or the infusion pump (27) of the post-dilution liquid line (25), or the pre-blood infusion pump (22) of the pre-blood pump pre-dilution infusion line (21), or the dialysis pump (17a), or the effluent pump (17) is an occlusion pump, optionally a peristaltic pump.

[0111] According to a seventy-ninth aspect, there is disclosed herein a method of blood flow recirculation in a disposable circuit, the disposable circuit comprising: a filtration unit (2), a blood circuit (6, 7) comprising a blood removal line (6) having a first end connected to an inlet of the filtration unit (2) and a blood return line (7) having a first end connected to an outlet of the filtration unit (2), the blood removal line (6) and the blood return line (7) being designed to be connected to the cardiovascular system of a patient, a blood circuit (6, 7), wherein the blood removal line (6) has a second end provided with an arterial connector (40), and the blood return line (7) has a second end provided with a venous connector (41), the arterial connector (40) and the venous connector (41) being designed to be detachably connected to a patient's vascular access, the blood circuit being configured to be coupled with a blood pump (11) for controlling flow within the blood circuit (6, 7); Equipped with The method involves the following steps: - stopping the blood pump (11) operating on the blood circuit; - disconnecting the arterial connector (40) from access to the patient's cardiovascular system; - disconnecting the venous connector (41) from access to the patient's cardiovascular system; - configuring the disposable circuit in a recirculation configuration by connecting at least one first auxiliary connector (51, 53, 55, 57, 59) arranged on the blood circuit (6, 7) or on at least one fluid line (15, 21, 25, 42, 42a) to the arterial connector (40) or the venous connector (41), after connection a closed circuit allowing fluid recirculation is defined, and optionally the step of configuring the disposable circuit in a recirculation configuration comprises connecting a second auxiliary connector (50, 52, 54, 56, 58) arranged on the blood circuit or on at least one fluid line (15, 21, 25, 42, 42a) to the other of the arterial connector (40) or the venous connector (41); Includes.

[0112] According to an eightieth aspect, there is disclosed herein a method of temporarily disconnecting a patient from an apparatus for extracorporeal treatment of blood, the apparatus comprising: a filtration unit (2) optionally having a primary chamber (3) and a secondary chamber (4) separated by a semipermeable membrane (5); a blood removal line (6) having a first end connected to the inlet of a filtration unit (2), e.g., a primary chamber (3), and a blood return line (7) having a first end connected to the outlet of the filtration unit (2), e.g., the primary chamber (3), wherein the blood removal line (6) and the blood return line (7) are a blood circuit (6, 7) designed to be connected to the cardiovascular system of a patient, a blood circuit (6, 7), wherein the blood removal line (6) has a second end provided with an arterial connector (40), and the blood return line (7) has a second end provided with a venous connector (41), the arterial connector (40) and the venous connector (41) being designed to be detachably connected to a vascular access device of a patient, the blood circuit being configured to interface with a blood pump (11) for controlling flow within the blood circuit (6, 7); at least one fluid line (15, 21, 25, 42, 42a) connected to the blood circuit (6, 7); the disposable circuit further comprises at least one first auxiliary connector (51, 53, 55, 57, 59) disposed on the blood circuit (6, 7) or on at least one fluid line (15, 21, 25, 42, 42a), and optionally a second auxiliary connector (50, 52, 54, 56, 58) disposed on the blood circuit or on at least one fluid line (15, 21, 25, 42, 42a), the method comprising: - stopping the blood pump operating on the blood circuit; - disconnecting the arterial connector (40) from the patient's access device; - disconnecting the venous connector (41) from the patient access device; - connecting one of the arterial connector (40) and the venous connector (41) to a first auxiliary connector (51, 53, 55, 57, 59) to define a recirculation configuration; - optionally connecting the other of the arterial connector (40) and the venous connector (41) to a second auxiliary connector (50, 52, 54, 56, 58) to define a closed circuit in the disposable circuit to define a recirculation configuration; -activating the blood pump and initiating recirculation of the liquid in the closed circuit while the patient remains disconnected from the device; Includes.

[0113] In particular, the disposable circuit of embodiment 80 is according to any one of the embodiments corresponding to the disposable circuits of 1-64, for example.

[0114] According to an eighty-second aspect, there is disclosed herein a method of constructing a disposable circuit of an apparatus for extracorporeal treatment of blood, the method comprising: - placing the disposable circuit according to any of the preceding aspects 1 to 78 in an apparatus for blood treatment comprising at least a blood pump (11) configured to force circulation of a liquid flow in at least the primary chamber (3) of a filtration unit, the disposable circuit leading to an operating configuration in which at least a part of the blood circuit (6, 7) interacts with said blood pump (11), the first auxiliary connector (51, 53, 55, 57, 59) and the second auxiliary connector (50, 52, 54, 56, 58) being disconnected from the arterial connector (40) and the venous connector (41); - configuring the disposable circuit in a recirculation configuration by connecting at least one first auxiliary connector (51, 53, 55, 57, 59) arranged on the blood circuit (6, 7) or on the fluid line (15, 21, 25, 42, 42a) to the arterial connector (40) or the venous connector (41), after connection a closed circuit allowing fluid recirculation is defined, and optionally the step of configuring the disposable circuit in a recirculation configuration includes connecting a second auxiliary connector (50, 52, 54, 56, 58) arranged on the blood circuit or on the fluid line (15, 21, 25, 42, 42a) to the other of the arterial connector (40) or the venous connector (41); Includes.

[0115] According to an 81st aspect, according to one or more of aspects 79 or 80, a method comprises: - stopping the blood pump to stop the recirculation of the liquid in the closed circuit; - disconnecting the arterial connector (40) or the venous connector (41) from the first auxiliary connector (51, 53, 55, 57, 59); - optionally disconnecting the other of the arterial connector (40) and the venous connector (41) from the second auxiliary connector (50, 52, 54, 56, 58); - reconnecting both the arterial connector (40) and the venous connector (41) to the patient's access device before resuming the procedure; further comprising The method steps are performed without modifying the disposable circuitry and / or without disconnecting the disposable circuitry from the device.

[0116] According to an eighty-first aspect according to one or more of aspects 79 or 80 or 81, the step of placing the disposable circuit on the device includes placing at least a portion of the disposable circuit according to a path provided on a graphical user interface of the device, such that the step of placing the disposable circuit on the device is optionally guided.

[0117] According to an 82nd aspect corresponding to one or more of aspects 79 to 81, connecting at least a first auxiliary connector (51, 53, 55, 57, 59) arranged on the blood circuit (6, 7) or on at least one liquid line (15, 21, 25, 42, 42a) with an arterial connector (40) or a venous connector (41), and defining a closed circuit that enables liquid recirculation after connection, includes moving the arterial connector (40) or the venous connector (41) toward the first auxiliary connector (51, 53, 55, 57, 59).

[0118] According to an 83rd embodiment corresponding to one or more of embodiments 79 to 82, connecting a second auxiliary connector (50, 52, 54, 56, 58) arranged on the blood circuit or on at least one liquid line (15, 21, 25, 42, 42a) with one of the arterial connector (40) or venous connector (41) that is not already connected to the first auxiliary connector (51, 53, 55, 57, 59) to define a closed circuit includes moving the arterial connector (40) or venous connector (41) toward the second auxiliary connector (50, 52, 54, 56, 58).

[0119] According to an 84th aspect corresponding to one or more of aspects 79 to 83, between the steps of disconnecting the arterial connector (40) and the venous connector (41) from the infusion line and configuring the disposable circuit in a recirculation configuration, the blood circuit is temporarily in an open circuit configuration.

[0120] According to an eighty-fourth aspect, in accordance with one or more of aspects seventy-nine to eighty-three, the method includes returning at least a portion of the extracorporeal blood to the patient before initiating recirculation.

[0121] According to the previous aspect, there is further provided a method for disconnecting one of the connectors between the arterial connector (40) and the venous connector (41) from the patient's vascular access device (specifically, the arterial connector) and connecting the disconnected connector to a bag containing saline, the method further including operating the blood pump to return the extracorporeal blood to the patient, and once at least a portion of the extracorporeal blood has been returned, disconnecting the connector from the bag and connecting it to either the first auxiliary connector or the second auxiliary connector.

[0122] According to the previous aspect, the method includes, following the return of blood, disconnecting the other of the arterial connector (40) and the venous connector (41) from the patient's vascular access device (specifically, the venous connector) and connecting it to the other of the first auxiliary connector and the second auxiliary connector.

[0123] According to an eighty-fourth aspect, the method includes, while the patient remains connected to the extracorporeal blood circuit, activating an infusion pump on the infusion line to push liquid contained in a bag associated with the infusion line into the blood circuit and return blood to the patient (without withdrawing blood from the patient), and optionally, the blood pump is activated and synchronized with the infusion pump.

[0124] According to the previous aspect, the method includes leaving at least one of the arterial and venous connectors connected to the patient's vascular access device (and preferably both connectors) during blood return. Instead of leaving both the arterial and venous connectors connected to the patient's vascular access device during blood return, one of the arterial and venous connectors is disconnected from the vascular access device and connected to either the first auxiliary connector or the second auxiliary connector, after which blood return begins. More specifically, this variation uses an infusion pump and associated solution bags (used for treatment), and the arterial line is set up "instantly" during the recirculation step. This is also an advantage of this option / variation because it does not require auxiliary fluid bags, while minimizing handling steps (and the risk of contamination).

[0125] According to the previous two aspects, the method includes, after returning the blood, disconnecting the venous connector from the patient's vascular access device and connecting the venous connector to either the first auxiliary connector or the second auxiliary connector.

[0126] According to the previous three aspects, the method includes, after returning the blood, disconnecting the arterial connector from the patient's vascular access device and connecting the arterial connector to either the first auxiliary connector or the second auxiliary connector.

[0127] According to any one of the previous aspects through aspect 84-2, after recirculation and before resuming treatment, a step of draining the saline used during recirculation is provided. For example, a drain bag may be connected to the venous connector, the arterial connector is reconnected to the patient's vascular access device, and a blood pump draws blood from the patient and pushes the saline into the drain bag.

[0128] According to an 85th aspect corresponding to any of aspects 79 to 84, the method further includes a step of clamping respective tube portions of at least one of the blood removal line and the blood return line (6, 7), the clamping step being performed before a step of disconnecting the arterial connector (40) and the venous connector (41) from the patient's vascular access; The method includes the step of unclamping the blood removal line and the blood return line after defining a closed circuit in a recirculation configuration.

[0129] According to an 86th aspect corresponding to the 85th aspect, the clamping is performed corresponding to the second end of the blood removal line (6) and the second end of the blood return line (7).

[0130] According to an 87th aspect corresponding to aspect 85 or aspect 86, the clamping step includes clamping at least one tubing portion of the blood removal line (6) or the blood return line (7), optionally clamping the tubing portion of the blood removal line (6) with a first manual clamp and clamping the tubing portion of the blood return line (7) with a second manual clamp.

[0131] According to an 88th aspect corresponding to one or more of aspects 79 to 87, the disposable circuit is disposed on an apparatus for extracorporeal circulation, and the steps of at least disconnecting the arterial connector (40) and the venous connector (41) from the vascular access and configuring the disposable circuit in a recirculation configuration are performed without removing the disposable circuit from the apparatus for extracorporeal circulation; The method includes the step of stopping at least one blood pump (11) of the device for extracorporeal circulation before performing the step of disconnecting the arterial connector (40) and the venous connector (41) from the vascular access; The method includes the step of reactivating at least the blood pump (11) of the device for extracorporeal circulation after the step of configuring the disposable circuit in a recirculation configuration has been performed.

[0132] According to an 89th aspect corresponding to aspect 88, the steps of stopping at least the blood pump (11) and re-activating at least the blood pump (11) are performed through user action, specifically on a user interface connected to the control unit (10), which manages the operation of at least the blood pump (11) and includes sending a stop signal to the blood pump (11) and sending a re-activation signal to the blood pump (11), respectively.

[0133] According to a 90th aspect corresponding to aspect 88 or 89, in conjunction with the step of stopping at least one blood pump (11) of the device for extracorporeal circulation, the dialysis pump (17a) operating on the dialysis (19) connected to the inlet of the secondary chamber (4) of the filtration unit (2) and the effluent pump (17) operating on the drain line (13) connected to the outlet of the secondary chamber (4) are stopped or bypassed from the filtration unit before performing the step of disconnecting the arterial connector (40) and the venous connector (41) from the infusion line.

[0134] Of course, all infusion pumps for infusing the blood circuit (if infusion lines exist) are also stopped.

[0135] According to a 91st aspect corresponding to one or more of aspects 79 to 90, the first auxiliary connector (51, 53, 55, 57, 59), optionally both the first auxiliary connector (51, 53, 55, 57, 59) and the second auxiliary connector (50, 52, 54, 56, 58), comprises at least one detachable port (70, 70a) configured to be connected to the venous connector (41) and / or the arterial connector (40), and the step of configuring the disposable circuit in the recirculation configuration includes connecting the detachable port (70, 70a) of the first auxiliary connector (51, 53, 55, 57, 59) to the detachable port (72) of the venous connector (41) or the arterial connector (40).

[0136] According to a 92nd aspect corresponding to aspect 91, the step of configuring the disposable circuit in a recirculation configuration includes connecting the detachable port (70, 70a) of the first auxiliary connector (51, 53, 55, 57, 59) to the detachable port (72) of the venous connector (41) and connecting the detachable port of the second auxiliary connector (50, 52, 54, 56, 58) to the arterial connector (40), or vice versa, connecting the detachable port (70, 70a) of the first auxiliary connector (51, 53, 55, 57, 59) to the detachable port (72) of the arterial connector (40) and connecting the detachable port of the second auxiliary connector (50, 52, 54, 56, 58) to the venous connector (41).

[0137] According to a 93rd aspect corresponding to aspects 79 to 92, the first auxiliary connector (51, 53, 55, 57, 59) and the second auxiliary connector (50, 52, 54, 56, 58) have respective detachable ports (70) of the same type, male or female, or the first auxiliary connector (51, 53, 55, 57, 59) has at least one removable port (70) of the male type and the second auxiliary connector (50, 52, 54, 56, 58) has at least one removable port (70) of the female type; or the first auxiliary connector (51, 53, 55, 57, 59) has at least one detachable port (70) of female type and the second auxiliary connector (50, 52, 54, 56, 58) has at least one detachable port (70) of male type; Steps of connecting the detachable ports (70, 70a) of the first auxiliary connector (51, 53, 55, 57, 59) to the detachable ports (72) of the venous connector (41) and connecting the detachable ports of the second auxiliary connector (50, 52, 54, 56, 58) to the arterial connector (40), or vice versa, connecting the detachable ports (70, 70a) of the first auxiliary connector (51, 53, 55, 57, 59) to the detachable ports (72) of the arterial connector (40) and connecting the detachable ports of the second auxiliary connector (50, 52, 54, 56, 58) to the venous connector (41).

[0138] According to a 94th aspect in accordance with one or more of the 79 to 93 aspects, the one or more liquid lines (15, 21, 25, 42, 42a) are: a post-blood pump pre-dilution infusion line (15) connected directly to the blood removal line (6); - a pre-dilution pre-infusion line (21) connected directly to the blood removal line (6), - a post-dilution fluid line (25) connected directly to the blood return line (7), One or more of the following are included: Each of the post-blood pump pre-dilution infusion line (15), the pre-blood pump pre-dilution infusion line (21), and the post-dilution liquid line (25) has a first end directly connected to the blood circuit (6, 7) and a second end opposite the first end configured to be or connected to a respective infusion liquid container (16, 23, 26), such that in a recirculation configuration, no liquid is drawn from the liquid container (16, 23, 26).

[0139] According to a 95th aspect, corresponding to one or more of aspects 79 to 94, the method further includes disposing at least one first pressure drop valve or flow resistor (60) configured to uniformly distribute the liquid flow during recirculation in at least one liquid line (15, 21, 25, 42, 42a), and optionally, the method includes adjusting the at least one first pressure drop valve or flow resistor (60) when the disposable circuit is in the recirculation configuration.

[0140] According to a 96th aspect, corresponding to aspects 79 to 95, the method comprises connecting at least a first auxiliary connector (51, 53, 55, 57, 59) arranged on the blood circuit (6, 7) or arranged on at least one fluid line (15, 21, 25, 42, 42a) with an arterial connector (40) or a venous connector (41), and optionally connecting a second auxiliary connector (51, 53, 55, 57, 59) arranged on the blood circuit or on at least one fluid line (15, 21, 25, 42, 42a) with an arterial connector (40) or a venous connector (41). The method includes connecting the auxiliary connectors (50, 52, 54, 56, 58) to the other of the arterial connector (40) and the venous connector (41), specifically, directly connecting a first auxiliary connector (51, 53, 55, 57, 59) to one of the arterial connector (40) or the venous connector (41), and directly connecting a second auxiliary connector (50, 52, 54, 56, 58) to the other of the arterial connector (40) and the venous connector (41).

[0141] According to a 97th embodiment corresponding to embodiment 94, in the recirculation configuration, liquid flows from the arterial connector (40) through the primary chamber (3) to the venous connector (41), or from the second end of the blood removal line (6) to the first end of the blood removal line (6) and from the first end of the blood return line (7) to the second end of the blood return line (7).

[0142] According to a 98th embodiment corresponding to embodiment 94, the first auxiliary connector (51) and the second auxiliary connector (50) are arranged on the post-blood pump pre-dilution injection line (15), and in a recirculation configuration, the first auxiliary connector (51) arranged on the post-blood pump pre-dilution injection line (15) is connected to the venous connector (41), and the second auxiliary connector (50) arranged on the post-blood pump pre-dilution injection line (15) is connected to the arterial connector (40).

[0143] According to a 99th aspect corresponding to aspect 94, the first auxiliary connector and the second auxiliary connector are arranged on the post-blood pump pre-dilution injection line (15), and in a recirculation configuration, the first auxiliary connector (51) arranged on the post-blood pump pre-dilution injection line (15) is connected to the arterial connector (40), and the second auxiliary connector (50) arranged on the post-blood pump pre-dilution injection line (15) is connected to the venous connector (41).

[0144] According to a 100th embodiment corresponding to embodiment 94, a first auxiliary connector (53) and a second auxiliary connector (52) are arranged on the pre-blood pump pre-dilution injection line (21), and in a recirculation configuration, the first auxiliary connector (53) arranged on the pre-blood pump pre-dilution injection line (21) is connected to the arterial connector (40), and the second auxiliary connector (52) arranged on the pre-blood pump pre-dilution injection line (21) is connected to the venous connector (41).

[0145] According to a 101st embodiment corresponding to embodiment 94, a first auxiliary connector (53) and a second auxiliary connector (52) are arranged on the pre-blood pump pre-dilution injection line (21), and in a recirculation configuration, the first auxiliary connector (53) arranged on the pre-blood pump pre-dilution injection line (21) is connected to the venous connector (41), and the second auxiliary connector (52) arranged on the pre-blood pump pre-dilution injection line (21) is connected to the arterial connector (40).

[0146] According to a 102nd embodiment corresponding to embodiment 94, the first auxiliary connector and the second auxiliary connector are arranged on the dilution liquid line (25), and in a recirculation configuration, the first auxiliary connector (57) arranged on the dilution liquid line (25) is connected to the arterial connector (40), and the second auxiliary connector (56) arranged on the dilution liquid line (25) is connected to the venous connector (41).

[0147] According to a 103rd embodiment corresponding to embodiment 94, the first auxiliary connector and the second auxiliary connector are arranged on the dilution liquid line (25), and in a recirculation configuration, the first auxiliary connector (57) arranged on the dilution liquid line (25) is connected to the venous connector (41), and the second auxiliary connector (56) arranged on the dilution liquid line (25) is connected to the arterial connector (40).

[0148] According to a 104th aspect corresponding to one or more of aspects 79 to 103, the first auxiliary connector and the second auxiliary connector are arranged on the blood circuit (6, 7), and in a recirculation configuration, the first auxiliary connector (59) arranged on the blood circuit (6, 7), specifically on the blood return line (7), is connected to the arterial connector (40), and the second auxiliary connector (58) arranged on the blood circuit (6, 7), specifically on the blood removal line (6), is connected to the venous connector (41).

[0149] According to a 105th aspect, there is disclosed herein a computer program product stored in at least one non-transitory memory support, comprising software code portions adapted to be executed by at least one data processing unit, the software code portions comprising at least - providing at least one first selection item on the graphical user interface for configuring the device for blood treatment in a treatment configuration, in which in a therapeutic configuration undesirable substances are removed from the blood via the circulation of blood in a blood circuit (6, 7) of a disposable circuit according to any of the preceding aspects 1 to 78 installed in the device, and providing a second selection item for configuring the device for blood treatment in a recirculation configuration; - determining the activation and deactivation steps of a blood pump (11) included in a device for extracorporeal blood recirculation and operating the blood circuit (6, 7), wherein, following the selection of the recirculation configuration, a deactivation signal is sent to deactivate the blood pump (11); is configured to run, The software code portion is further configured to cause execution of a reactivation of the blood pump (11) following receipt of a confirmation command entered by a user, the command corresponding to confirmation that the disposable circuit is in a recirculation configuration.

[0150] According to a 106th aspect, in accordance with aspect 105, the stop signal is an electrical control signal sent from a control unit (10) of the device to the blood pump (11).

[0151] According to a 107th embodiment corresponding to embodiment 106 or embodiment 105, following selection of the recirculation configuration, the software code portion causes the display of a visual guide on the screen of the device intended to assist in configuring the disposable circuit in the recirculation configuration, and then, upon input of a confirmation command by the user, causes the device to switch to a "standby confirmation" state.

[0152] According to a 108th aspect according to one or more of the preceding aspects, the control unit (10) is configured to provide, through a user interface, at least one selection item for selecting at least one of a plurality of treatment modes, the treatment modes being hemodialysis (HD), hemofiltration with predilution (HF), pre ), hemofiltration with postdilution (HF post ), hemofiltration with both pre- and post-dilution (HF pre-post ), hemodiafiltration with predilution (HDF pre ), hemodiafiltration with postdilution (HDF post ), hemodiafiltration with both pre- and post-dilution (HDF pre-post ), ultrafiltration (UF), and controls at least the operation of the device according to the selected treatment mode. [Brief explanation of the drawings]

[0153] Aspects of the present invention are illustrated in the accompanying drawings, which are provided as non-limiting examples. [Figure 1] FIG. 1 shows a general schematic diagram of a disposable circuit according to an embodiment of the present invention. [Figure 2] , [Figure 3] 2 and 3 show an exemplary type of connection for the auxiliary connector of a disposable circuit according to an embodiment of the present invention when the auxiliary connector is placed on the pre-blood pump pre-dilution infusion line. [Figure 4] , [Figure 5] 4 and 5 show exemplary types of connections for auxiliary connectors of disposable circuits according to embodiments of the present invention when the auxiliary connector is placed on the post-blood pump pre-dilution infusion line. [Figure 6] FIG. 6 shows a specific partial schematic diagram of the disposable circuit configuration. [Figure 7] , [Figure 8] 7 and 8 show exemplary types of connections for auxiliary connectors of disposable circuits according to embodiments of the present invention when the auxiliary connector is placed on a post-dilution fluid line. [Figure 9] FIG. 9 shows a specific partial schematic diagram of the disposable circuit configuration. [Figure 10] , [Figure 11] 10 and 11 show alternative types of connections for auxiliary connectors of disposable circuits according to embodiments of the present invention when the auxiliary connector is disposed on a blood circuit. [Figure 12] , [Figure 13] , [Figure 14] 12, 13 and 14 show exemplary types of connections for auxiliary connectors of disposable circuits according to embodiments of the present invention when the auxiliary connector is located on one or two auxiliary lines. [Figure 15] , [Figure 16] , [Figure 17] , [Figure 18] , [Figure 19] 15-19 show alternative configurations for the auxiliary connector of the disposable circuit. [Figure 20]FIG. 20 shows a flow chart of some of the operational steps required to switch from a processing configuration to a recirculation configuration for purposes of the device and disposable circuit of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0154] A non-limiting embodiment of a device 1 for extracorporeal treatment of blood that can implement the innovative aspects of the present invention is shown in the figure. In the following description and in the figures, like components are identified by like reference numerals.

[0155] FIG. 1 shows an apparatus 1 designed to provide extracorporeal blood treatment to a patient, such as treatment to remove undesirable substances from the patient's blood.

[0156] According to a further embodiment, a device for extracorporeal blood treatment by hemoperfusion and / or Extracorporeal CO2 Removal (ECCO2R) is also included within the scope of the present invention.

[0157] In non-limiting embodiments, the device 1 is capable of performing the following treatments: hemodialysis (HD), hemofiltration with predilution (HF), pre ), hemofiltration with postdilution (HF post ), hemofiltration with both pre- and post-dilution (HF pre-post ), hemodiafiltration with predilution (HDF pre ), hemodiafiltration with postdilution (HDF post ), hemodiafiltration with both pre- and post-dilution (HDF pre-post ), ultrafiltration (UF). The device may alternatively provide plasma filtration.

[0158] The device 1 comprises a disposable circuit for blood processing, which comprises several elements identified below. For purposes of the present invention, "disposable" shall mean a specifically designed element intended to be discarded or disposed of after use, specifically after a single use. It should be noted, in particular, that "single use" refers to the processing of a single patient. It is understood that temporary disconnection of a patient from the device 1 during an incomplete process does not interrupt a single process, and that reconnection of the patient to the disposable circuit after temporary disconnection still falls within the scope of a single use as defined herein. According to any of the non-limiting embodiments described below, elements that are part of the disposable circuit are marked with bold lines in the accompanying drawings, and elements that are part of the device 1 are marked with thin lines, which helps the reader clearly identify which elements belong to the disposable circuit and which elements are part of the device. The disposable circuits described below may be detachably connected to the device, sold separately from the device 1, or, in any case, provided separately from the device 1.

[0159] The disposable circuit comprises a filtration unit 2 such as a hemofilter, ultrafilter, hemodialyzer, dialyzer, plasma filter, gas exchanger, sorbent cartridge, etc. In particular, in the first example according to FIG. 1 which deals specifically with a dialysis machine, the filtration unit may have a primary chamber 3 and a secondary chamber 4 separated by a semipermeable membrane 5, and depending on the treatment, the membrane of the filtration unit may be selected to have different properties and performances.

[0160] The disposable circuit includes a blood removal line 6 connected to the inlet of the primary chamber 3 and a blood return line 7 connected to the outlet of the primary chamber 3. In use, the blood removal line 6 and the blood return line 7 are connected to a vascular access device in communication with the patient's vasculature. For example, the blood removal line and the blood return line may be connected to a fixed catheter (e.g., a central venous catheter for acute patients) or to respective needles, specifically, but not limited to, metal needles (e.g., inserted into an arteriovenous fistula for chronic patients), or other access devices (not shown in the accompanying figures) that are arranged in fluid communication with the patient's vasculature, such that blood can be withdrawn through the blood removal line, flow through the primary chamber, and then returned to the patient's vasculature through the blood return line in a first configuration of the disposable circuit, described herein as the "operating configuration" or "processing configuration." The blood return line 7 and the blood removal line 6 are made of a flexible plastic material. In a non-limiting solution, the blood removal line 6 and the blood return line 7 are made of a transparent plastic material, allowing the presence of blood to be identified.

[0161] More specifically, the blood removal line 6 has a first end connected to the inlet of the primary chamber 3 and a second end opposite the first end connected to an arterial connector 40, which is the final part of the disposable circuit located downstream of an arterial access 40a that provides access to the vascular system of the patient "P", and the blood return line 7 has a first end connected to the outlet of the primary chamber 3 and a second end opposite the first end connected to a venous connector 41, which is the final part of the disposable circuit upstream of a venous access 41a of the patient "P".

[0162] Throughout the course of this disclosure, references will be made to "downstream" and "upstream" to indicate the location of elements relative to one another. As shown by arrow F in FIG. 1 , the normal flow of fluid imposed by blood pump 11 is from arterial connector 40 to venous connector 41, and therefore the terms "downstream" and "upstream" refer to such flow. Thus, in an operational configuration, fluid travels from arterial connector 40 through portion 6a of blood removal line 6 to blood pump 11, which forces flow at the inlet of primary chamber 3, then through filter 2 to the outlet of primary chamber 3. The fluid then travels within blood return line 7 to its second end, which is connected to venous connector 41. For example, blood pump 11 is located upstream of primary chamber 3, and the outlet of primary chamber 3 is downstream of the inlet of primary chamber 3 and / or blood pump 11.

[0163] The arterial connector 40 and the venous connector 41 are non-detachable connectors each including a port fixed (e.g., welded or glued) to the tubing section (the blood removal line and the blood return line) and a free port detachably connectable to the arterial access 40a or the venous access 41a (e.g., an arterial needle and a venous needle or catheter), respectively. The free ports of the arterial connector and the venous connector can be male or female. Preferably, the free ports of both the arterial connector 40 and the venous connector 41 are the same type. Figures 18 and 19 show non-limiting, schematic embodiments of the arterial or venous connector in which the free port 72 is female (Figure 18) or male (Figure 19). Luer connectors are preferably used. Because they are the same connection type, the arterial connector 40 and the venous connector 41 cannot be directly connected to each other.

[0164] At least one air separator such as a bubble trap 8 is present in the blood circuits 6, 7, preferably on the blood return line (another bubble trap may also be provided in the withdrawal line), and furthermore a safety clamp 9 of the device operates on the blood return line, which is usually located downstream of the bubble trap 8 and near the venous connector 41. The safety clamp 9 can be controlled by a control unit 10 of the device 1. It should be noted that the air separator and the safety clamp are optional elements, but their presence is preferred.

[0165] Additionally, the device further comprises an air bubble sensor 8a operating in correspondence with a portion of the return line 7 between the bubble trap 8 and the safety clamp 9, the air bubble sensor being connected to the control unit 10 and sending a signal to the control unit if one or more air bubbles are detected, in which case the control unit may stop the process and close the clamp 9. A corresponding safety clamp of the device (not shown) may be provided in correspondence with the blood removal line 6. The safety clamp operates on the blood removal line 6 just downstream of the arterial connector 40.

[0166] As shown in Figure 1, blood flow through the blood lines is controlled by a blood pump 11, e.g., a peristaltic blood pump, acting on either the blood removal line or the blood return line. The blood pump 11 is a peristaltic blood pump that is part of the device 1. The operator can control the blood flow rate Q via a user interface 12. B A set value for the blood flow rate may be input (or the device may calculate the blood flow rate based on other set parameters), and the control unit 10 is configured to control the blood pump based on the set / calculated blood flow rate during processing. In the course of this description, the control unit is referred to as being "configured" or "programmed" to perform certain steps, which may in fact be achieved by any means that makes it possible to configure or program the control unit.

[0167] The device 1 comprises a (graphical) user interface configured to allow setting parameters for processing and to give command and control to the device 1 in its various operational configurations. The user interface may comprise a screen or monitor, optionally touch-sensitive, one or more switches and / or push buttons specifically configured to trigger specific operations of the device 1.

[0168] The disposable circuit further comprises a drain line 13 connected at one end to the outlet of the secondary chamber 4 and at the other end to a drain container 14 for collecting used liquid extracted from the secondary chamber. Alternatively, the drain line 13 may conduct the used liquid directly to a drain. The drain line is arranged to be connected to a drain pump 17 of the device which operates on the drain line under the control of the control unit 10 to regulate a flow rate Q across the drain line. eff Adjust.

[0169] The dialysate line 19 is connected at one end to a dialysate container 20 (or a dialysate preparation device) and at the other end to the inlet of the secondary chamber 4 of the filtration unit. The dialysate line 19 of the fluid circuit is arranged to cooperate with a dialysate pump 17a of the device 1. The dialysate pump 17a operates on the dialysate fluid line under the control of the control unit 10 to pump a flow rate Q from the dialysate container to the secondary chamber. dial The unused dialysis fluid is supplied.

[0170] According to a specific embodiment for acute treatment, the disposable circuit may comprise the above-mentioned drain line 13 and dialysate line 19 as disposable components integrally fixed to the filtration unit. At the end of treatment, the entire disposable set is disposed of. The dialysate line 19 receives unused fluid from a container 20, and the used dialysate is sent to a drain bag 14.

[0171] In contrast, chronic renal treatment disposables do not include dialysate or drain lines as disposable components. The dialysate and drain lines are non-disposable fluid pathways disposed within the device 1. Detachable connections are provided for removably placing the dialysate and drain lines in fluid communication with the inlet and outlet, respectively, of the secondary chamber 4 of the filtration unit, the latter being part of the disposable circuit. The dialysate is either prepared online by mixing concentrate with water or received from a central dialysate preparation plant.

[0172] In the context of this disclosure, the terms "upstream" and "downstream" refer to the fluid flow imposed by effluent pump 17 and dialysis pump 17a, indicated in Figure 1 by arrow F'. Effluent pump 17 and dialysis pump 17a cooperate to force fluid to flow from dialysate container 20 through dialysate line 19 to dialysis pump 17a, then into the inlet of secondary chamber 4, through filter 2, to the outlet of secondary chamber 4, into effluent line 13, and then into effluent container 14.

[0173] The dialysate pump 17a and the effluent pump 17 are part of the means for regulating the flow of fluid through their respective lines and are operatively connected to a control unit 10 which controls the pumps, as described above. The control unit 10 is also connected to a user interface 12, e.g., a graphic user interface, which receives operator input and displays device output. For example, the graphic user interface 12 may include a touch screen, a display screen, hard or soft keys for entering user input, or a combination thereof.

[0174] The disposable circuit shown in Fig. 1 may comprise an infusion line 21 connected at one end to the portion 6a of the blood removal line 6 located upstream of the blood pump 11, and at the other end an infusion fluid container 23 which may contain a local anticoagulant, for example a citrate solution, or a substitution fluid or other liquid. This infusion line will hereinafter be referred to as the pre-blood pump pre-dilution infusion line 21. The means for regulating the flow of liquid comprise a pump 22, for example a peristaltic pump controlled by the control unit 10, acting on a segment of the pre-blood pump pre-dilution infusion line 21 to regulate the pre-blood pump infusion volume Q pbp A pump 22 for regulating the flow rate is part of the device 1 .

[0175] For purposes of this disclosure, the three-way connector described above is a "non-detachable connector," meaning that in normal use, the connector is not configured to be disconnected from any portion of the conduit connected at any of its three ports, or equivalently, the portion of the conduit connected at any of its three ports is fixedly joined to it, for example, by gluing or sealing.

[0176] The embodiment of Figure 1 also includes a post-blood pump pre-dilution fluid line 15, one end of which is connected directly to a portion 6a of the blood removal line 6 located downstream of the blood pump 11, and the other end of which is connected to a further infusate container, which supplies substitution fluid from an infusate container 16 connected at one end of the post-blood pump pre-dilution fluid line 15. The device operates on the pre-blood pump pre-dilution fluid line 15 to regulate the flow rate Q through the line 15. pre The device further includes an infusion pump 18, such as a peristaltic pump, for regulating the flow rate of the blood.

[0177] When referring to the post-blood pump pre-dilution infusion line 15 or the pre-blood pump pre-dilution infusion line 21, the terms "upstream" and "downstream" refer to the normal flow of fluid during operation. Fluid flows from the reservoir 16, 23 through the portion of the conduit line served by either pump 18, 22 of the infusion line to the non-detachable connector connecting the infusion line to the blood removal line 6.

[0178] 1 may also have, instead of or in combination with the pre-dilution liquid line 15, a post-dilution liquid line 25 connected at one end to a further container 26 of infusion liquid and at the other end to the blood return line 7. A further pump 27, for example a peristaltic pump, may act on the post-dilution liquid line 25 under the control of the control unit 10 and may therefore also be part of the means for regulating the flow through the liquid line.

[0179] When referring to post-dilution fluid line 25, the terms "upstream" and "downstream" refer to the normal flow of fluid in an operational configuration. Fluid flows from reservoir 26, through a portion of the conduit line acted upon by pump 27, to a non-detachable connector connecting the infusion line to blood return line 7.

[0180] Alternatively, or in combination with the aforementioned fluid lines, the device of Figure 1 may include one or more auxiliary lines, one end of which is connected to the blood circuit, e.g., to the blood removal line 6. Figure 1 shows a single auxiliary line 42. Additional pumps not shown in Figure 1, e.g., peristaltic pumps, may act on the auxiliary lines under the control of the control circuit 10 and thus may also be part of the means for regulating flow through the fluid lines.

[0181] When referring to any of the auxiliary lines, the terms "upstream" and "downstream" refer to the normal flow of fluid from the free end of the auxiliary line to the end connected to the blood circuit 6,7.

[0182] The device 1 may also include a first scale 33 operable to provide weight information for the amount of spent fluid collected in the effluent container 14, a second scale 34 operable to provide weight information for the amount of fluid delivered from the infusate container 16 via the post-blood pump pre-dilution infusion line 15, and a third scale 35 operable to provide weight information for the amount of fluid delivered from the dialysate container 20. If more infusion lines are present, there may be respective scales 36, 37 to provide weight information for the amount of fluid delivered from the infusion containers 23, 26 as the pre-blood pump pre-dilution infusion line 21, the post-dilution fluid line 25, and the dialysate container 20. All of the scales are connected to the control unit 10 and provide the weight information to the control unit 10 to determine the actual amount of fluid in each container and / or the actual flow rate of fluid delivered by or received in each container. The control unit 10 may then be configured to receive the treatment selection information and check whether the user has entered the required dialysis parameters. The control unit may also be configured to receive weight information from a first scale associated with a container supplying a line involved in delivering the selected treatment in response to the selected treatment, and to control, at least at the start of the treatment, a flow rate of at least one of the effluent, infusate, and dialysate by controlling the means for adjusting based on the weight information.

[0183] From a structural standpoint, one or more, and optionally all, of the containers 14, 16, 20, 23, and 26 may be disposable plastic containers, preferably soft plastic bags suspended on supports supported by respective scales. The means for regulating flow typically includes a pump, although other regulating means can also be used, such as a valve or a combination of a valve and a pump. The scale may include a piezoelectric sensor, a strain gauge, a spring sensor, or any other type of transducer capable of sensing a force applied thereto. While the illustrated example shows the use of a scale to determine the amount of liquid in each container and to enable calculation of the respective flow rates through the various lines, it should be noted that the above-described aspects of the present invention are also applicable to blood processing machines that use a volume sensor to determine flow rate or a combination of mass and volume sensors.

[0184] While the preceding description primarily referenced dialysis devices, embodiments of the present disclosure also encompass hemoperfusion. Hemoperfusion is a method of extracorporeal filtering of blood to remove one or more toxins. Similar to other extracorporeal methods, blood travels from the patient through a blood removal line 6, is filtered in a filtration unit 2, and then returns to the patient through a blood return line 7, typically using venous access. In hemoperfusion, the blood perfuses a filter composed of artificial cells filled with activated carbon or other microporous material. In a hemoperfusion device, an infusion line may not be present. In such cases, a first auxiliary connector and a second auxiliary connector may be disposed on the blood line, for example, in a location as disclosed below in accordance with the fourth embodiment. A further possible hemoperfusion configuration may include a pre-blood pump pre-infusion line to infuse a solution into the blood upstream of the blood pump. In this latter embodiment, the first and second auxiliary connectors may be placed on the pre-blood pump pre-infusion line or may remain on the blood circuit (or one connector may be placed on the pre-blood pump pre-infusion line and the other on the blood line).

[0185] Furthermore, the device of embodiments may (alternatively or additionally) be an extracorporeal CO2 removal (ECCO2R) device, and the blood line circuit may be connected to the CO2 removal filtration unit 2, and the device may or may not include any infusion line. The first and second auxiliary connectors may be located on the blood circuit if an infusion line is not available, or on either the blood circuit or the infusion line if present.

[0186] The disposable circuit of the present disclosure is designed to allow temporary disconnection and subsequent reconnection of the patient to the same disposable circuit to continue (temporarily) interrupted treatment. To accomplish this task, the disposable set is primarily reconfigurable to allow recirculation of fluid (e.g., blood) within the blood circuit. Instead of the aforementioned treatment (operational) configuration, another configuration of the disposable circuit described herein is referred to as the "recirculation configuration." In this configuration, the patient is disconnected from the disposable circuit, and fluid present therein can be recirculated to allow the patient to separate from the extracorporeal blood treatment device. This embodiment allows the patient to temporarily disconnect from the device 1 and perform other tests or treatments while treatment by the device 1 is suspended, eliminating the need for a complete replacement of the expensive disposable circuit and reducing the health risks associated with the disconnect-recirculate-reconnect operation. Furthermore, no additional components are required to achieve the temporary disconnection, such as an additional "Y" connector, saline bag, etc. The ability to easily switch or reconfigure between the operational and recirculation configurations further facilitates the activities of a qualified operator who assists the patient throughout the performance of treatment. During the recirculation configuration, i.e., after the control unit 10 has been properly configured for the recirculation configuration, the flow rate and / or target means values ​​for a given operation are suspended, and the average values ​​calculated and / or measured by either the control unit 10 or a sensor operatively connected thereto are preferably stored in memory. The calculations and / or measurements are resumed at the end of the patient's temporary disconnection when the control unit 10 has been properly configured to re-establish the original operating configuration of the blood treatment; optionally, and preferably, the control unit 10 may be configured to allow calculation and / or measurement of partial values ​​before the introduction of the recirculation configuration and after the re-introduction of the operating configuration.

[0187] To this end, some embodiments of the disposable circuit have been contemplated as including first and second auxiliary connectors, one connected to the venous connector 40 and the other to the arterial connector 41 in a recirculation configuration, for the purpose of defining a properly closed circuit that allows for recirculation of liquid under operation of the blood pump 11. While the detailed disclosure of the present embodiments always discloses two auxiliary connectors, in principle, at least one auxiliary connector may be sufficient to form a closed circuit. In fact, although not preferred, it is possible to connect one blood line end (venous or arterial) to the first auxiliary connector and leave the other blood line end dead-end (the second blood end, i.e., the dead-end end, is simply clamped). Liquid within the closed loop can then be recirculated. Preferably, saline or other substitution fluid should be recirculated (i.e., not blood).

[0188] Preferably, but not by way of limitation, the auxiliary connectors are three-way connectors having a main inlet and a main outlet for receiving the piece of main line to which they are routed, and include at least one detachable port that may be sealed via a cap, or alternatively, may be of a self-sealing type, such that the port automatically seals when another connector is disconnected from the detachable port of the auxiliary connector and automatically opens when another connector is connected to the detachable port of the auxiliary connector. A self-sealing auxiliary connector helps prevent unwanted leakage of liquid (e.g., blood) when patient treatment is interrupted and the configuration of the disposable circuit is switched between the operating and recirculation configurations, reduces the risk of air bubbles being included in the blood circuit, and further facilitates the actions performed by a qualified operator assisting the patient.

[0189] The auxiliary connector may have a wide variety of shapes and may include at least one first, or even second, detachable and free port that may be used to connect the auxiliary connector to another auxiliary connector and / or one of the venous and arterial connectors. Non-limiting configurations of connectors according to the present disclosure include three-way auxiliary connectors, such as a "T" connector (FIG. 15).

[0190] The illustrated connector (which may be the first or second auxiliary connector) includes a first non-detachable service port 71 and a second non-detachable service port 71 secured (e.g., sealed) to the respective flexible tubing sections. For example, the tubing sections may be the respective tubing sections of the pre-blood pump pre-dilution line 21; alternatively, the tubing sections may be the tubing sections of any other infusion line, or the tubing sections of the blood removal or blood return lines, respectively. The detachable port 72, which is shown only diagrammatically, may be a male (or female) Luer connector configured to mate with the corresponding female (or male) Luer connector 40, 41 of the blood removal line 6 or blood return line 7. Obviously, a "Y" connector, a half-snowflake connector, or another connector of a different geometry may also be used.

[0191] 16, the first and second auxiliary connectors may be made in a single piece, with the first and second non-detachable service ports 71 still being secured (e.g., sealed) to their respective flexible tubing sections, but the merged connector including two detachable ports 70, 70a for respectively receiving the extract line connector 40 and the return line connector 41. Also, in this design, if the extract line connector 40 and the return line connector 41 are Luer male connectors, the two detachable ports 70 are Luer female connectors, and vice versa.

[0192] The geometry of the "integral" connector may also be different, such as in the embodiment of Figure 17, where two detachable ports 70 appear alongside each other on the same side of the device.

[0193] FIG. 1 presents in a single schematic diagram the primary, non-limiting embodiment devised by the inventors, which is described in further detail herein.

[0194] First embodiment In the first embodiment, the first auxiliary connector 53 and the second auxiliary connector 52 are disposed on the pre-blood pump, pre-dilution infusion line 21 and, when the disposable circuit is properly installed in the device 1, are located in a portion of the conduit downstream of the pump 22 disposed on the pre-blood pump, pre-dilution infusion line 21. The first auxiliary connector 53 is disposed downstream of the second auxiliary connector 52.

[0195] In a recirculation configuration, instead, the first auxiliary connector 53 is connected to the arterial connector 40 and the second auxiliary connector 52 is connected to the venous connector 41 (FIG. 2), or The first auxiliary connector 53 is connected to the venous connector 41 and the second auxiliary connector 52 is connected to the arterial connector 40 (Figure 3).

[0196] 2, a total flow (double arrow) is present in the blood removal line 6 and blood return line 7 downstream of the pre-blood pump, pre-dilution infusion line 21, and the total flow reaches the second auxiliary connector 52, where it is split into a partial flow (single arrow) present in the portion of the line connecting the second auxiliary connector 52 and the first auxiliary connector 53, and a partial flow (single arrow) present in the portion of the line connecting the arterial connector 40 and the infusion point of the pre-blood pump, pre-dilution infusion line 21 on the blood removal line 6. Here, the two partial flows recombine to produce the total flow.

[0197] In Figures 2 and 3, double arrows indicate the total flow rate and direction along the line, and single arrows indicate the split (partial) flow rate and direction along the line section. The same representation is used for all figures showing recirculation.

[0198] In the first embodiment, the first and second auxiliary connectors are both three-way connectors, each including a detachable port 70 configured to connect to a detachable port 72 of a connector selected between the venous connector 40 and the arterial connector 41 according to one of the two possible alternatives identified above. The detachable ports 72 of the first and second auxiliary connectors 53, 52 are of a type opposite to the type of the detachable ports of the venous and arterial connectors. In other words, when the detachable ports 72 of the first and second auxiliary connectors 53, 52 are of a male type, the detachable ports of the arterial and venous connectors are of a female type, and vice versa.

[0199] Second embodiment In the second embodiment, the first auxiliary connector 51 and the second auxiliary connector 50 are disposed on the post-blood pump pre-dilution infusion line 15 and, when the disposable circuit is properly installed in the device 1, are located in a portion of the conduit downstream of the pump 18 disposed on the post-blood pump pre-dilution infusion line 15. The first auxiliary connector 51 is disposed downstream of the second auxiliary connector 50.

[0200] In a recirculation configuration, instead, the first auxiliary connector 51 is connected to the venous connector 41 and the second auxiliary connector 50 is connected to the arterial connector 40 (Figure 4), or The first auxiliary connector 51 is connected to the arterial connector 40 and the second auxiliary connector 50 is connected to the venous connector 41 (Figure 5).

[0201] In the recirculation configuration of Figure 4, the total flow is present in the blood removal line 6 upstream of the post-blood pump pre-dilution infusion line 15, the total flow is divided at the infusion point of line 15, and partial flows are present in the blood return line 7, the venous connector 41 up to the first auxiliary connector 51, where the partial flow coming from the blood removal line and the partial flow up to the first auxiliary connector 50 join together, and the total flow is present as depicted in the portion of the line connecting the first auxiliary connector 51 and the second auxiliary connector 50 and up to the blood removal line 6.

[0202] In the second embodiment, the first auxiliary connector 51 and the second auxiliary connector 50 are both three-way connectors, each including a detachable port 70 configured to connect to another detachable port 72 of a connector selected between the venous connector 40 and the arterial connector 41 according to one of the two possible alternatives identified above. The detachable ports 72 of the first auxiliary connector 51 and the second auxiliary connector 50 are of a type opposite to the types of the detachable ports of the venous and arterial connectors. In other words, when the detachable ports 72 of the first auxiliary connector 51 and the second auxiliary connector 50 are of a male type, the detachable ports of the arterial and venous connectors are of a female type, and vice versa.

[0203] 6, the post-blood pump pre-dilution infusion line 15 may optionally include a pressure drop valve or flow resistor 60, specifically and non-limitingly located downstream of the first auxiliary connector 51 and immediately upstream of the non-detachable three-way connector connecting the post-blood pump pre-dilution infusion line 15 to the blood removal line 6. The pressure drop valve or flow resistor 60 is configured to equalize the flow resistance during recirculation and may be detachably or fixedly located in the liquid line; optionally, the drop valve or flow resistor may be of a variable resistance type. The purpose of the drop valve or flow resistor 60 is to equalize the resistance of each section of pipe so that the flows occurring in each circuit branch are as similar as possible.

[0204] Third embodiment In the third embodiment, the first auxiliary connector 57 and the second auxiliary connector 56 are disposed on the dilution fluid line 25 and, when the disposable circuit is properly installed in the device 1, are located in a portion of the conduit downstream of the pump 27 disposed on the dilution fluid line 25. The first auxiliary connector 57 is disposed downstream of the second auxiliary connector 56.

[0205] In a recirculation configuration, instead, the first auxiliary connector 57 is connected to the arterial connector 40 and the second auxiliary connector 56 is connected to the venous connector 41 (Figure 7), or The first auxiliary connector 57 is connected to the venous connector 41 and the second auxiliary connector 56 is connected to the arterial connector 40 (Figure 8).

[0206] In the recirculation configuration of Figure 7, the total flow rate is present in the portion of the blood removal line 6 and the blood return line 7 that originates from the outlet of the primary chamber 3 and reaches the non-detachable connector that connects the blood return line 7 to the post-dilution liquid line 25, and partial flow rates are present in the portion of the line connecting the first auxiliary connector 57 and the second auxiliary connector 56 and in the portion of the blood return line 7 downstream of the post-dilution liquid line 25.

[0207] In the third embodiment, the first and second auxiliary connectors are both three-way connectors, each including a detachable port 70 configured to connect to another detachable port 72 of a connector selected between venous connector 40 and arterial connector 41 according to one of the two possible alternatives identified above. The detachable ports 72 of first auxiliary connector 57 and second auxiliary connector 56 are of a type opposite to the types of the detachable ports of the venous and arterial connectors. In other words, when the detachable ports 72 of first auxiliary connector 57 and second auxiliary connector 56 are of a male type, the detachable ports of the arterial and venous connectors are of a female type, and vice versa.

[0208] 9, the post-dilution fluid line 25 may optionally include a pressure drop valve or flow resistor 60, specifically located downstream of the first auxiliary connector 57 and immediately upstream of the non-detachable three-way connector connecting the post-dilution fluid line 25 to the blood return line 7. The pressure drop valve or flow resistor 60 is configured to equalize the flow resistance during recirculation and may be detachably or fixedly installed on the fluid line; optionally, the drop valve or flow resistor may be of a variable resistance type.

[0209] Fourth embodiment In the fourth embodiment, the first auxiliary connector 59 and the second auxiliary connector 58 are both disposed on the blood circuit, with the first auxiliary connector 59 disposed on the blood return line 7 and the second auxiliary connector 58 disposed on the blood removal line 6. Preferably, but not limited to, the second auxiliary connector 58 is disposed on the portion 6a of the blood withdrawal line 6 that is located upstream of the blood pump 11 when the disposable circuit is properly installed in the device 1, and the first auxiliary connector 59 is preferably located upstream of the air bubble detector 8a and the safety clamp 9. Thus, the first auxiliary connector 59 is disposed downstream of the second auxiliary connector 58.

[0210] In the recirculation configuration of FIG. 10, the first auxiliary connector 59 is connected to the arterial connector 40 and the second auxiliary connector 58 is connected to the venous connector.

[0211] In the recirculation configuration of Figure 10, the total flow is present in the blood withdrawal line 6 downstream of the second auxiliary connector 58 and upstream of the first auxiliary connector 59, i.e., in the respective portions of the blood withdrawal line 6 between the second auxiliary connector 58 and the inlet of the primary chamber 3, and in the portion of the blood return line 7 between the outlet of the primary chamber and the first auxiliary connector 59, and partial flow is present in the portion of the blood recovery line 6 located between the second auxiliary connector 58 and the arterial connector 40, and in the blood return line 7 located between the first auxiliary connector 59 and the venous connector 41.

[0212] In the fourth embodiment, the first auxiliary connector and the second auxiliary connector are both three-way connectors and include a detachable port 70 configured to connect to another detachable port 72 of a selected one of the connectors, venous connector 40 and arterial connector 41. The detachable ports 72 of the first auxiliary connector 59 and the second auxiliary connector 58 are of a type opposite to the type of the detachable ports of the venous connector and the arterial connector. In other words, when the detachable ports 72 of the first auxiliary connector 59 and the second auxiliary connector 58 are of a male type, the detachable ports of the arterial connector and the venous connector are of a female type, and vice versa.

[0213] 11 shows an alternative connection in which the first and second auxiliary connectors are both disposed on the blood removal line 6, with the venous connector 41 connected directly to the second auxiliary connector 58 and the arterial connector 40 connected directly to the first auxiliary connector 59 disposed downstream of the second auxiliary connector 58, at the line section 6a upstream of the blood pump 11. Note that this latter configuration should not be considered preferred, but is nevertheless still acceptable for defining a closed circuit that allows for the recirculation of liquid as contemplated in the present disclosure.

[0214] Fifth embodiment In the fifth embodiment, the first auxiliary connector 55 and the second auxiliary connector 54 are both disposed on a single auxiliary line that is preferably, but non-limitingly, located in a portion of the blood removal line upstream of the blood pump 11, for example, in a portion of the blood removal line 6, when the disposable circuit is properly disposed on the device 1. In the fifth embodiment, the first auxiliary connector 55 is disposed downstream of the second auxiliary connector 54.

[0215] In a recirculation configuration, instead, the first auxiliary connector 55 is connected to the arterial connector 40 and the second auxiliary connector 54 is connected to the venous connector 41 (FIG. 12), or The first auxiliary connector 55 is connected to the venous connector 41 and the second auxiliary connector 56 is connected to the arterial connector 40 (Figure 13).

[0216] In the recirculation configuration of Figure 12, the total flow is present in the blood removal line 6 and blood return line 7 downstream of the auxiliary line 42, and a partial flow is present in the auxiliary line 42 and the portion of the blood removal line 6 included between the three-way non-detachable connector connecting one end of the auxiliary line 42 to the blood removal line 6 and the second end of the blood removal line 6 terminating in the arterial connector 40.

[0217] In a fifth embodiment, one connector between the first and second auxiliary connectors is a three-way connector including a severable port 70 configured to connect to another severable port 72 of a connector selected between the venous connector 40 and the arterial connector 41 according to one of the two possible alternatives identified above. The other connector is a two-way connector including a severable port and a non-severable port fixedly attached to a respective tubing portion of the auxiliary line 42. The severable ports 72 of the first and second auxiliary connectors 55, 54 are of a type opposite to that of the venous and arterial connectors. In other words, when the severable ports 72 of the first and second auxiliary connectors 55, 54 are of a male type, the severable ports of the arterial and venous connectors are of a female type, and vice versa.

[0218] The fifth embodiment is similar to the first embodiment, but uses a service line 42 instead of the process line 21 for temporary disconnection and recirculation.

[0219] Sixth embodiment A sixth embodiment of the disposable circuit is shown schematically in Figure 14 and preferably, but non-limitingly, includes a first auxiliary line 42 and a second auxiliary line 42a disposed on a portion of the blood removal line 6, both of which are located upstream of the blood pump 11 and, optionally, upstream of the pre-blood pump, pre-infusion line 21, when the disposable circuit is properly disposed on the device 1. The first auxiliary line 42 and the second auxiliary line 42a each have a first end connected to the blood removal line 6 and a second end terminating in a first auxiliary connector 55 disposed on the first auxiliary line 42 and a second auxiliary connector 54 disposed on the second auxiliary line 42a, respectively.

[0220] In a recirculation configuration, instead, the first auxiliary connector 55 is connected to the venous connector 41 and the second auxiliary connector 54 is connected to the arterial connector 40 (Figure 15), or - A first auxiliary connector 55 is connected to the arterial connector 40 and a second auxiliary connector 56 is connected to the venous connector 41 (not shown in either figure as it is substantially symmetrical to the configuration of Figure 15).

[0221] In the recirculation configuration of Figure 15, the total flow rate is present in the blood removal line 6 and blood return line 7 downstream of the second auxiliary line 42a, and the partial flow rate is present in the first auxiliary line 42, the second auxiliary line 42a, and the portion of the blood removal line 6 including the portion upstream of the three-way non-detachable connector connecting one end of the first auxiliary line 42 and the three-way non-detachable connector connecting one end of the second auxiliary line 42a to the second end where the blood removal line 6 ends at the arterial connector 40.

[0222] In the sixth embodiment, both the first and second auxiliary connectors are two-way connectors with severable and non-severable ports fixedly attached to the tubing portions of the first and second auxiliary lines, 42, respectively. The severable ports 72 of the first and second auxiliary connectors, 55 and 54, are of the opposite type to the severable ports of the venous and arterial connectors. In other words, when the severable ports 72 of the first and second auxiliary connectors, 55 and 54, are of the male type, the severable ports of the arterial and venous connectors are of the female type, and vice versa.

[0223] Finally, it is not excluded that the first and second auxiliary connectors may be arranged on any one of the described infusion lines and on another one of the blood circuits so as to appropriately enable blood recirculation when connected to the arterial connector 41 and the venous connector 40.

[0224] How it works The method of operation of the disposable circuit according to the present disclosure will now be described in detail in the context that the patient may be temporarily disconnected from the device 1, and therefore from the disposable circuit, during blood processing.

[0225] In use, before starting the treatment configuration, the disposable circuit is installed in the device 1. To facilitate installation of the disposable circuit and reduce the risk of errors made by a qualified operator during installation, the device 1 may provide visual instructions on the GUI to help the operator perform the correct placement. The control unit 10 provides machine configuration options prior to treatment on the screen of the user interface of the device 1. Once the prescription and related parameters are entered, the disposable circuit is properly prepared, after which the blood circuit is connected to the patient's vascular access and treatment begins.

[0226] If the process must be temporarily suspended, the user interface has a corresponding screen where an option, for example an icon, for the recirculation configuration can be selected by the user.

[0227] 24, when the patient has to be disconnected from the device 1, the user selects the recirculation configuration option on the screen of the device 1, and the control unit 10 then configures the device 1 to a specific configuration in which first at least the blood pump 11, and preferably all pumps of the device 1, are stopped (block 1000). Since the blood pump 11 is the pump primarily responsible for forcing the circulation of fluid from the arterial connector to the venous connector, both in the operating configuration and in the recirculation configuration, stopping at least the blood pump 11 is necessary to switch or reconfigure the device 1 to the above-mentioned recirculation configuration, and thus to switch the disposable circuit from the processing configuration to the recirculation configuration and vice versa.

[0228] Without limitation, a stop signal may also be sent to the effluent pump 17 and the dialysis pump 17a. If the dialysate continues to circulate in the fluid circuit, at least the ultrafiltration is stopped or set to a minimum very low value. Of course, one or more infusion pumps may be running and the infusion fluid may be balanced by the ultrafiltration.

[0229] Then (block 1001), the patient is disconnected from the apparatus 1, and the user (and / or the apparatus) clamps the ends of the blood line and then disconnects the arterial connector 40 and the venous connector 41 from the access device (e.g., a central catheter or access needle), so that the arterial connector 40 and the venous connector 41 are in fact free at their respective detachable ends and ready to be connected to the respective free ends of the auxiliary connectors, according to one of the embodiments described above.

[0230] Generally, the user disconnects the first connector, and typically the arterial connector 40 is disconnected first. The disconnected (e.g., arterial) connector is then connected to either the first or second auxiliary connector, depending on the selected recirculation configuration. Thereafter, the second connector (e.g., venous connector 41) is disconnected and subsequently connected to the free one of the first and second auxiliary connectors that define the recirculation configuration. In other words, the user sequentially disconnects and connects the arterial and venous connectors.

[0231] 24, the first and second auxiliary connectors are then connected to the venous connector 41 and the arterial connector 40, preferably in accordance with the disclosure of any of the configurations of the previous embodiments. If the first and second auxiliary connectors are self-sealing, the operator typically does not need to remove closure caps from the auxiliary connector's detachable ports 70, 70a; otherwise, the operator must properly remove any protective and / or closure caps from the detachable ports before properly setting up the auxiliary connector's connection to the arterial and venous connectors 40, 41, respectively. Of course, if the self-sealing connectors do not have caps, the self-sealing ports may need to be cleaned / disinfected before connection to the self-sealing ports.

[0232] It is further noted that the flexibility of the conduits of the disposable circuits disclosed herein allows for easy reconfiguration, leaving the circuits in place on the device 1 during switching or reconfiguration from the operating configuration to the recirculation configuration. In many cases, portions of the blood circuits 6, 7 near both the arterial connector 40 and the venous connector 41 may be more easily accessible and / or free or otherwise remote from their at least temporarily defined positions on the pathways on the device 1. Therefore, the step of interconnecting the auxiliary connector with either the venous connector 40 or the arterial connector 41 may preferably be performed by moving a portion of the blood circuits 6, 7 so that the venous connector (or arterial connector) is first physically approached and then brought into contact with the free end port of the respective auxiliary connector. This facilitates user operation and further reduces the time required for reconfiguration of the circuits and devices. This aspect allows for rapid reconfiguration to the recirculation configuration.

[0233] Once the proper connections between the first auxiliary connector, the second auxiliary connector and the arterial and venous connectors 40, 41 have been established, the blood line is unclamped and the operator must quickly intervene on the user interface of the device 1 to set a command for reactivation of at least the blood pump 11. This step is shown diagrammatically in block 1003 of Fig. 24. Preferably, this is done through interaction with a specific icon provided on the screen of the device 1 or through an action on a specific activation button on the device 1 (block 1003, Fig. 24).

[0234] During recirculation of liquid in the recirculation configuration, it is undesirable for liquid contained in any of the liquid lines connected to the blood circuits 6, 7 to be drained therefrom. Therefore, according to the recirculation process, any pumps in the liquid lines connected to the blood circuits 6, 7 are deactivated and idled throughout the recirculation process. This is particularly suitable when the first and second auxiliary connectors are arranged downstream of both pumps in the liquid lines, since stopping the pumps acts as a means for preventing free circulation of liquid in the respective liquid lines upstream of the pumps. This advantage is further enhanced when the pumps acting on the liquid lines are occlusion pumps, such as peristaltic pumps, because this latter type of pump not only provides additional resistance to liquid flow when not in operation, but also substantially completely closes the conducting portion of the liquid line, physically preventing liquid from draining from the upstream portion of the liquid line. Thus, contamination of liquid contained upstream of any pump in the lines introducing liquid into the blood circuits 6, 7 is prevented, or at any rate significantly reduced.

[0235] In a first alternative, the effluent pump 17 and the dialysis pump 17a are stopped when the liquid is recirculated in the disposable circuit in the recirculation configuration, and in a second alternative, the effluent pump 17 and the dialysis pump 17a remain operating when the liquid is recirculated in the disposable circuit in the recirculation configuration (but ultrafiltration is not achieved).

[0236] When the patient's temporary disconnection is terminated, i.e., when the patient is reconnected to the device 1 via the venous connector 40 and the auxiliary connector 41 to terminate the temporary interruption of blood processing, the user selects a specific command on a user interface operatively connected to the control unit 10 to stop the operation of the blood pump 11. If the effluent pump 17 and the dialysis pump 17a remained running during the recirculation of the fluid, they may also be stopped. The operator then clamps and disconnects the venous connector 40 and the arterial connector 41 from the first and second auxiliary connectors to which they are connected, respectively. The closed circuit configuration established when the recirculation configuration of the disposable circuit was initiated is then terminated, and the disposable circuit is temporarily opened. If the first and second auxiliary connectors are not self-sealing, the operator provides for closing their free detachable ends; otherwise, if the first and second auxiliary connectors are self-sealing, this latter operator action is not required.

[0237] The venous connector 40 and the arterial connector 41 are then reconnected to the patient's access device and unclamped, and via the menu of the control unit 10 on the screen, the user selects the option corresponding to resuming blood treatment, and the pumps of the apparatus 1, in particular at least the blood pump 11, are then reactivated. Reactivation preferably also occurs for the effluent pump 17 and the dialysis pump 17a, as well as any infusion pumps (required by the set treatment mode) to enable treatment delivery.

[0238] It should be noted that the above disconnection procedure does not require returning blood to the patient prior to temporary disconnection (although this is also possible), thus allowing for recirculation of the patient's blood within the blood line and ultimately within the portion of the infusion line involved.

[0239] As an alternative procedure, the extracorporeal blood may be returned to the patient before recirculation. According to this embodiment, after the blood pump is stopped and the blood removal line 6 is clamped, the arterial connector 40 is disconnected from the patient's access device and connected to a bag containing saline (e.g., saline or substitution fluid). The blood removal line is unclamped, and the blood pump is reactivated to return blood to the patient via the blood return line, which is still connected to the vascular access. Once the blood has returned, the blood removal line is clamped, and the arterial connector is connected to the first or second auxiliary connector, as appropriate. The blood return line is then clamped, and the venous connector 41 is disconnected from the access device and connected to the other of the first and second auxiliary lines. The user then unclamps the blood line and begins recirculating the saline in the recirculation circuit.

[0240] In particular, if an infusion line is present on the circuit, the contents of the bag supplying the infusion line can be used to provide a suitable fluid for blood restoration. That is, the drainage line is clamped and the infusion pump (and blood pump, if necessary) is activated so that the fluid enters the blood line and pushes the blood through the blood return line and vascular access to the patient. This alternative procedure can be performed even before the arterial connector is removed.

[0241] During fluid recirculation, the usual alarms, such as the access, arterial and venous pressure alarms, are deactivated or their alarm windows are modified. Indeed, the different conditions during recirculation are incompatible with the usual alarm thresholds, and without modification / deactivation, some false alarms will be generated.

[0242] The process parts described therein may be provided via a data processing unit technically interchangeable with one or more data processing units designed to execute parts of a software or firmware program loaded into a memory support. The software or firmware program may be written in any known programming language. Two or more electronic computers may be connected to each other via a data connection so that their computing power can be shared; thus, the electronic computers may be installed in different locations, thereby realizing a data connection in a distributed computing environment. The data processing unit or control unit may be a general-purpose processor specifically configured to execute one or more parts of the processes defined in this disclosure via a software or firmware program, or may be an ASIC, dedicated processor, or FPGA specifically programmed to execute at least some of the operations of the processes described herein. The memory support may be located inside or outside the processor, control unit, or data processing unit, or may be located geographically remote therefrom.

[0243] The present invention is not limited to the embodiments shown in the drawings. Accordingly, where reference signs follow recited features in the appended claims, it will be understood that such signs are included solely for the purpose of enhancing the clarity of the claims and do not limit the scope of the claims.

[0244] Finally, it is clear that any adaptation or addition may be made to any of the elements forming part of this disclosure without departing from the scope of protection afforded by the appended claims.

Claims

1. 1. A disposable circuit for extracorporeal treatment of blood, comprising: a filtration unit (2), a blood circuit (6, 7) comprising a blood removal line (6) having a first end connected to the inlet of the filtration unit (2) and a blood return line (7) having a first end connected to the outlet of the filtration unit (2), the blood removal line (6) and the blood return line (7) being designed to be connected to the cardiovascular system of a patient, a blood circuit (6, 7), wherein the blood removal line (6) has a second end provided with an arterial connector (40), and the blood return line (7) has a second end provided with a venous connector (41), the arterial connector (40) and the venous connector (41) being designed to be detachably connected to a vascular access device of a patient, the blood circuit being configured to be coupled with a blood pump (11) for controlling flow within the blood circuit (6, 7); at least one liquid line (15, 21, 25, 42, 42a) connected to said blood circuit (6, 7); a first auxiliary connector (51, 53, 55, 57, 59) arranged either on the blood circuit (6, 7) or on the at least one liquid line (15, 21, 25, 42, 42a), the first auxiliary connector (51, 53, 55, 57, 59) configured to be removably connected to one of the arterial connector (40) and the venous connector (41) in a recirculation configuration so as to define a closed circuit allowing recirculation of liquid within the blood circuit; a second auxiliary connector (50, 52, 54, 56, 58) arranged on the blood circuit or on the at least one liquid line (15, 21, 25, 42, 42a), the first auxiliary connector (51, 53, 55, 57, 59) and the second auxiliary connector (50, 52, 54, 56, 58) being configured to be removably connected to the arterial connector (40) on the one hand and the venous connector (41) on the other hand so as to define the closed circuit; 1. A disposable circuit comprising:

2. 1. A disposable circuit for extracorporeal treatment of blood, comprising: a filtration unit (2), a blood circuit (6, 7) comprising a blood removal line (6) having a first end connected to the inlet of the filtration unit (2) and a blood return line (7) having a first end connected to the outlet of the filtration unit (2), the blood removal line (6) and the blood return line (7) being designed to be connected to the cardiovascular system of a patient, a blood circuit (6, 7), wherein the blood removal line (6) has a second end provided with an arterial connector (40), and the blood return line (7) has a second end provided with a venous connector (41), the arterial connector (40) and the venous connector (41) being designed to be detachably connected to a vascular access device of a patient, the blood circuit being configured to be coupled with a blood pump (11) for controlling flow within the blood circuit (6, 7); - first auxiliary connectors (51, 53, 55, 57, 59) arranged on the blood circuit (6, 7), the first auxiliary connectors (51, 53, 55, 57, 59) being configured to be removably connected to one connector between the arterial connector (40) and the venous connector (41) in a recirculation configuration so as to define a closed circuit allowing recirculation of liquid in the blood circuit; - a second auxiliary connector (50, 52, 54, 56, 58) arranged on the blood circuit, the first auxiliary connector (51, 53, 55, 57, 59) and the second auxiliary connector (50, 52, 54, 56, 58) being configured to be removably connected to the arterial connector (40) on the one hand and the venous connector (41) on the other hand so as to define the closed circuit; 1. A disposable circuit comprising:

3. 3. The disposable circuit of claim 1, wherein the disposable circuit is reversibly configurable between a processing configuration in which the arterial connector (40) and the venous connector (41) are detachably connected to the vascular access device of a patient and blood is withdrawn from the patient through the blood removal line (6), circulated through the filtration unit (2), and returned to the patient through the blood return line (7), and a recirculation configuration in which the arterial connector (40) and the venous connector (41) are detachably connected to the first auxiliary connector (51, 53, 55, 57, 59) and the second auxiliary connector (50, 52, 54, 56, 58), wherein in the recirculation configuration, liquid contained within the blood circuit (6, 7) is recirculated within the disposable circuit.

4. 4. The disposable circuit according to claim 1, wherein both the first auxiliary connector (51, 53, 55, 57, 59) and the second auxiliary connector (50, 52, 54, 56, 58) are three-port connectors having a detachable port (70) configured to be connected to one of the venous connector (41) and the arterial connector (40); Both the first auxiliary connector (51, 53, 55, 57, 59) and the second auxiliary connector (50, 52, 54, 56, 58) a first non-detachable service port (71) and a second non-detachable service port (71) fixed to each tube section; - said detachable port (70); 1. A disposable circuit comprising:

5. 2. The disposable circuit according to claim 1, wherein the at least one liquid line (15, 21, 25, 42, 42a) is one of the following lines: - a post-blood pump pre-dilution infusion line (15) connected directly to said blood withdrawal line (6), - a pre-blood pump pre-dilution infusion line (21) connected directly to said blood removal line (6), - a post-dilution liquid line (25) connected directly to the blood return line (7), One or more of the following are provided: the first auxiliary connector (51, 53, 55, 57, 59) comprises a first non-detachable service port (71) and a second non-detachable service port (71) secured to each tubing section of the liquid line (15, 21, 25, 42, 42a) in which the first auxiliary connector is disposed.

6. 10. A disposable circuit according to claim 1, 5, or claim 3 or 4 dependent on claim 1, characterized in that the second auxiliary connector (51, 53, 55, 57, 59) comprises a first non-detachable service port (71) and a second non-detachable service port (71) fixed to each tubing section of the liquid line (15, 21, 25, 42, 42a) in which the second auxiliary connector is arranged.

7. 7. The disposable circuit of claim 6, wherein the first auxiliary connector (51, 53, 55, 57, 59) and the second auxiliary connector (50, 52, 54, 56, 58) are fixed to the same fluid line.

8. 2. The disposable circuit according to claim 1, wherein the at least one fluid line (15, 21, 25, 42, 42a) comprises a pre-blood pump pre-dilution infusion line (21) directly connected to the blood removal line (6), the first auxiliary connector (53) and the second auxiliary connector (52) are fixed to the pre-blood pump pre-dilution infusion line (21), and in the recirculation configuration, the first auxiliary connector (53) arranged on the pre-blood pump pre-dilution infusion line (21) is connected to the arterial connector (40), and the second auxiliary connector (52) arranged on the pre-blood pump pre-dilution infusion line (21) is connected to the venous connector (41).

9. 9. The disposable circuit of claim 8, wherein the first auxiliary connector (53) is disposed on the pre-blood pump pre-dilution infusion line (21) downstream of the second auxiliary connector (52).

10. 2. The disposable circuit according to claim 1, wherein the at least one fluid line (15, 21, 25, 42, 42a) comprises a pre-blood pump pre-dilution infusion line (21) configured to allow fluid administration to the blood circuit downstream of the arterial connector (40), the pre-blood pump pre-dilution infusion line (21) comprising a peristaltic pump path configured to couple with a corresponding peristaltic pump and a container, the pre-blood pump pre-dilution infusion line (21) being connected to the container, and the first auxiliary connector (53) and the second auxiliary connector (52) being connected to the pre-blood pump pre-dilution infusion line (21) downstream of the peristaltic pump path.

11. 10. A disposable circuit according to claim 1, claims 5 to 9, and claims 3 or 4 dependent on claim 1, comprising a first pressure drop valve or flow resistor (60) configured to equalize the distribution of liquid flow during recirculation, the first pressure drop valve or flow resistor (60) being arranged on the blood circuit or on the at least one liquid line (15, 21, 25, 42, 42a), the first pressure drop valve or flow resistor (60) being configured to equalize the flow resistance of liquid in each of two connected branch tubing sections during recirculation, the first pressure drop valve or flow resistor (60) being arranged on one of the two connected branch tubing sections comprising the part of the liquid line (15, 21, 25, 42, 42a) and the part of the blood circuit (6, 7).

12. 12. The disposable circuit of any one of claims 1 to 11, a drain line (13) connected to the outlet of the secondary chamber (4); a dialysate line (19) connected to the inlet of the secondary chamber (4); Furthermore, The disposable circuit is a CRRT disposable circuit.

13. 3. The disposable circuit according to claim 1, wherein the first auxiliary connector (51, 53, 55, 57, 59) and the second auxiliary connector (50, 52, 54, 56, 58) are arranged on the blood circuit (6, 7), and in the recirculation configuration, the first auxiliary connector (59) arranged on the blood return line (7) is connected to the arterial connector (40), and the second auxiliary connector (58) arranged on the blood removal line (6) is connected to the venous connector (41).

14. 13. The disposable circuit according to any one of claims 1 to 12, wherein both the first auxiliary connector (51, 53, 55, 57, 59) and the second auxiliary connector (50, 52, 54, 56, 58) comprise detachable ports (70, 70a) configured to correspondingly connect to detachable ports (72) of either the venous connector (41) or the arterial connector (40).

15. 15. The disposable circuit of claim 14, wherein both the first auxiliary connector (51, 53, 55, 57, 59) and the second auxiliary connector (50, 52, 54, 56, 58) are three-port connectors with a detachable port (72), the detachable port (70) configured to be connected to the venous connector (41) or the arterial connector (40).

16. 16. The disposable circuit of claim 15, the detachable ports (70, 70a) of the first auxiliary connector (51, 53, 55, 57, 59) and the detachable ports (72) of the arterial connector (40) or the venous connector (41) are either of a first male type or of a second female type, the first male type being adapted to be at least partially introduced into the second female type; - both the arterial connector (40) and the venous connector (41) are connectors with detachable ports (72) of the first male type, or alternatively - a disposable circuit, characterized in that both said arterial connector (40) and said venous connector (41) are provided with a detachable port (72) of said second female type.

17. 17. The disposable circuit of claim 16, wherein the first auxiliary connector (51, 53, 55, 57, 59) and the second auxiliary connector (50, 52, 54, 56, 58) have the detachable ports (70) both of a male type or both of a female type.

18. 13. A disposable circuit according to claim 1 and any one of claims 3 to 12 dependent on claim 1, characterized in that the first auxiliary connector (51, 53, 55, 57, 59) and the second auxiliary connector (50, 52, 54, 56, 58) are mounted upstream of each other on the liquid line, the liquid line having its own liquid pump path in which a liquid pump operates, and the first auxiliary connector (51, 53, 55, 57, 59) and the second auxiliary connector (50, 52, 54, 56, 58) are arranged downstream of the liquid pump path.

19. 12. The disposable circuit according to any one of claims 1 to 11, which is a CRRT disposable circuit for use in a renal failure device for extracorporeal treatment of blood in the acute field, characterized in that the CRRT disposable circuit comprises a disposable dialysate line (19) permanently connected to the inlet of the secondary chamber (4) and a disposable drain line (13) permanently connected to the outlet of the secondary chamber (4).

20. 20. The disposable circuit according to any one of claims 1 to 19, characterized in that in a recirculation configuration, fluid flows from the arterial connector (40) through the primary chamber (3) to the venous connector (41), from the venous connector (41) to the second auxiliary connector (50, 52, 54, 56, 58), from the second auxiliary connector (50, 52, 54, 56, 58) to the first auxiliary connector (51, 53, 55, 57, 59), and from the first auxiliary connector (51, 53, 55, 57, 59) to the arterial connector (40).

21. 21. The disposable circuit of any one of claims 1 to 20, wherein the first auxiliary connector (51, 53, 55, 57, 59) and the second auxiliary connector (50, 52, 54, 56, 58) are separate connectors or the first auxiliary connector and the second auxiliary connector are made of a single piece.

22. 22. An apparatus for extracorporeal treatment of blood, comprising a disposable circuit according to any one of claims 1 to 21, said apparatus further comprising a control unit (10) and a blood pump (11) configured to control the flow of blood in the blood circuit (6, 7), The control unit (10) - stopping the blood pump (11), - receiving a command to activate the recirculation of the liquid in said blood circuit (6, 7); - when the disposable circuit is in a recirculation configuration, actuating the blood pump (11) to recirculate the liquid in the blood circuit (6, 7); The device is configured to:

23. 23. The device of claim 22, wherein in the recirculation configuration, the first auxiliary connector (51, 53, 55, 57, 59) is connected directly to either the arterial connector (40) or the venous connector (41), and the second auxiliary connector (50, 52, 54, 56, 58) is connected directly to the other of the arterial connector (40) and the venous connector (41), and the control unit (10) is configured to maintain the disposable circuit in the recirculation configuration. wherein during recirculation, either the total flow rate of liquid entering the first auxiliary connector (51, 53, 55, 57, 59) or the second auxiliary connector (50, 52, 54, 56, 58) is divided into separate partial flow rates, or two partial flow rates of liquid entering the first auxiliary connector (51, 53, 55, 57, 59) or the second auxiliary connector (50, 52, 54, 56, 58) are combined and exit as a total flow rate.

24. 24. The apparatus according to claim 22 or 23, wherein the arterial connector (40) and the venous connector (41) are detachably connected to the vascular access device of a patient, and blood is drawn from the patient through the blood removal line (6), circulated through the filtration unit (2), and returned to the patient through the blood return line (7), wherein the control unit (10) is configured to: - the flow rate of the liquid through the discharge line (13) (Q ｅｆｆ ), the flow rate (Q) of the liquid through at least one inlet liquid line (15, 21, 25, 42, 42a) ｐｒｅ , Q ｐｂｐ , Q ｐｏｓｔ ), the flow rate of the fluid through the dialysate fluid line (19) (Q ｄｉａｌ ), the rate of fluid withdrawal from the patient (Q ｐｆｒ ), blood flow (Q ｂ receiving or calculating a flow rate of one or more liquids selected from the group comprising: - actuating one or more of said blood pump (11), infusion pump (18, 22, 27), dialysis pump (17a), effluent pump (17) to deliver said received or calculated flow rate; The apparatus is configured to:

25. 24. The device according to claim 22 or 23, wherein for activating the recirculation arrangement, the control unit (10) comprises: - receiving a command to activate the temporary recirculation of the liquid in said blood circuit (6, 7); - setting a value for the recirculation flow rate through said blood circuit (6, 7), - activating the blood pump (11) when in the recirculation configuration to recirculate the liquid in the blood circuit (6, 7); It is configured as follows: The recirculation configuration is performed after the arterial connector (40) and the venous connector (41) are detachably connected to the patient's vascular access device, a processing configuration in which blood is withdrawn from the patient through the blood withdrawal line (6), circulated through the filtration unit (2), and returned to the patient through the blood return line (7) is interrupted, and the flow rate of liquid in the blood circuit (6, 7) is momentarily reduced to zero by stopping the blood pump (11) and one or more infusion pumps (18, 22, 27).

26. 26. The device according to claim 25, characterized in that the control unit (10) is configured to obtain electronic confirmation of the disconnection of the arterial connector (40) and the venous connector (41) before enabling the operation of the blood pump (11) for recirculation.

27. 26. The apparatus according to any one of claims 22 to 25, wherein the arterial connector (40) and the venous connector (41) are detachably connected to the vascular access device of a patient, and blood is drawn from the patient through the blood removal line (6), circulated through the filtration unit (2), and returned to the patient through the blood return line (7), wherein the first auxiliary connector (51, 53, 55, 57, 59) and the second auxiliary connector (50, 52, and wherein in the recirculation configuration, the first auxiliary connectors (51, 53, 55, 57, 59) are connected directly to one connector between the arterial connector (40) and the venous connector (41), and the second auxiliary connectors (50, 52, 54, 56, 58) are connected directly to the other connector between the arterial connector (40) and the venous connector (41).

28. 22. A method of operating a device for temporary disconnection of a patient from a device for extracorporeal treatment of blood, said device comprising a disposable circuit according to any one of claims 1 to 21, said method comprising: - when one of the arterial connector (40) and the venous connector (41) disconnected from the patient's access device is connected to the first auxiliary connector (51, 53, 55, 57, 59), and the other of the arterial connector (40) and the venous connector (41) disconnected from the patient's access device is connected to the second auxiliary connector (50, 52, 54, 56, 58), a closed circuit is defined in the disposable circuit to define the recirculation configuration, and the patient remains temporarily disconnected from the apparatus, the blood pump is operated and begins recirculation of liquid in the closed circuit. A method comprising:

29. 29. The method of claim 28, - stopping the blood pump and stopping the recirculation of liquid in the closed circuit before one of the arterial and venous connectors (40, 41) is disconnected from the first auxiliary connector (51, 53, 55, 57, 59) and the other of the arterial and venous connectors (40, 41) is disconnected from the second auxiliary connector (50, 52, 54, 56, 58), and before reconnecting the arterial and venous connectors (40, 41) to the patient's access device before resuming the procedure; further comprising 10. A method, wherein the steps of the method are performed without modifying the disposable circuit and without disconnecting the disposable circuit from the device.

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