A disposable circuit for extracorporeal treatment of blood, a device for extracorporeal treatment of blood and associated 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 return line (7) designed to be connected to the cardiovascular system of a patient, wherein the blood withdrawal line (6) and the blood return line (7) are provided with an arterial connector (40) and a venous connector (41) which are detachably connected to a vascular access device of the patient; at least one fluid line (15, 21, 25, 42; 42a) is connected to the blood circuit (6, 7) and the disposable circuit further comprises a first auxiliary connector (51, 53, 55, 57, 59) and a second auxiliary connector (50, 52, 54, 56, 58) which are arranged on the blood circuit (6, 7) or on the fluid line (15, 21, 25, 42; 42a) and are configured to be removably connected with the arterial connector (40) and the venous connector (41) in a recirculation configuration so as to define a closed circuit which allows fluid recirculation.

Description

Technical Field

[0001] This disclosure relates to a disposable circuit for extracorporeal blood processing that can be configured for fluid recirculation, an apparatus for extracorporeal blood processing, a method for recirculating blood flow in a disposable circuit, and an associated computer program product.

[0002] Disposable circuits are particularly suitable for temporarily disconnecting patients from devices used for extracorporeal blood processing and then reconnecting them to the same disposable circuit for processing operations. Background Technology

[0003] Extracorporeal blood processing involves removing blood from a patient, processing the blood outside the patient's body, and returning the processed blood to the patient. For example, extracorporeal blood processing is commonly used to remove unwanted substances or molecules from a patient's blood and / or to add desired substances or molecules to the blood. Extracorporeal blood processing is used for patients from whom substances cannot be effectively removed from their blood, such as when a patient has temporary or permanent kidney failure. These and other patients may undergo extracorporeal blood processing to, for example, add or remove substances from their blood to maintain acid / base balance or remove excess fluid.

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

[0005] Several different types of extracorporeal blood treatments can be performed. In ultrafiltration (UF) treatment, unwanted substances are removed from the blood by convection through a membrane into a secondary chamber. In hemofiltration (HF) treatment, blood flows through a semipermeable membrane, such as in UF, and desired substances are typically added to the blood by dispensing fluid into the blood before and / or after the blood passes through the filtration unit and before it is returned to the patient. In hemodialysis (HD) treatment, a secondary fluid containing desired 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, while desired substances from the secondary fluid can pass through the membrane into the blood. In hemodialysis filtration (HDF) treatment, blood and secondary fluid exchange substances as in HD, and substances are added to the blood, typically by dispensing fluid into the treated blood before it is returned to the patient, as in HF.

[0006] Specific blood processing devices have been developed for treating acute patients, primarily due to: - In acute patients, the total treatment time is unknown in advance and therefore cannot be used as a setting parameter because it is unknown how long the renal insufficiency will persist; in fact, acute patients usually require a relatively long course of treatment, typically lasting several days, before recovering from renal failure. - Critical care devices can be designed to request multiple flow rate information as setting parameters; - Acute patients require very precise control of fluid removal; in addition, the infusion of drugs or fluids should generally also be controlled very precisely. - Acute patients are also very weak; therefore, in the management of acute patients, it has been considered that it is related to ensuring that the patient is given continuous and gentle treatment during the treatment with very precise control of the flow rate in each line connected to the blood line. - In addition, the device is usually required to operate in emergency situations, so the device for emergency treatment is characterized by being very easy to program.

[0007] Treatment for some patients may involve very long procedures, in which blood is treated for several days or even weeks; this is the case with continuous renal replacement therapy (CRRT), where the blood processing device can operate continuously for several days. Regardless of whether the treatment is for continuous renal replacement or for acute or chronic patients, there may be situations where the patient may need to be disconnected from the device while treatment is still ongoing. This is the case, for example, when a patient is scheduled to undergo medical examinations performed outside the renal unit or when an intervention on the vascular access is to be performed abruptly. Disconnecting and reconnecting the blood processing device from the blood circuit tubing requires disconnecting these lines from the patient, particularly from the venous and arterial connectors located at the ends of the blood circuit device (e.g., disconnecting the patient from the corresponding venous and arterial needles inserted into a fistula for chronic treatment or from a catheter fixed to the patient for emergency treatment).

[0008] Such temporary disconnection is critical for at least the following reasons: The disconnection and reconnection of the blood circuits in a blood processing device should be performed under aseptic conditions, requiring a qualified operator who may not interact with the device's control unit, which is typically not sterile. Stagnant blood in the device's blood circuits may clot; therefore, the blood processing device should be kept in an inoperable state for a very short time to avoid compromising patient safety. On the other hand, for at least economic reasons, complete replacement of disposable circuits should be avoided during temporary interruptions in treatment; in this latter case, replacement of disposable circuits would mean a significantly higher cost per single treatment.

[0009] Document US9713670 discloses a method for temporarily interrupting extracorporeal blood treatment of a patient using a blood processing device. The method includes activating a control device configured to allow the blood processing device to be interrupted so that the blood treatment process can be resumed. The end of the blood tubing 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] Document US2009 / 221949 describes a device for circulatory isolation and treatment of a part of a patient's body. A pump draws fluid from a venous reservoir for delivery to a heater and oxygenator unit. The outlet of the oxygenator unit is connected to a first arterial Y-connector. The main outlet of the first arterial Y-connector is connected to the patient's arterial catheter via a main arterial catheter. On the venous side, blood or fluid from the patient is delivered via a venous catheter through a pre-venous catheter and a venous Y-connector. The shunt inlet of the venous Y-connector is connected to the shunt outlet of the first arterial Y-connector via a shunt catheter. The main outlet is connected to the venous reservoir using an integrated filter. A third port of the connector allows fluid to be delivered to a collection bag 159.

[0011] Document US6913588 illustrates an external circuit that is linearly connected to an existing blood filtration system. The blood filtration system is connected from the patient's vein into a catheter equipped with a blood pump. Anticoagulants and replacement fluids are infused into the catheter using the pump to prevent blood clotting and to replace blood volume lost as waste. Blood enters the blood filter, where ultrafiltrate is separated from the blood. After filtration, the blood leaves the blood filter along the blood tubing, through a shunt and catheter, and returns to the patient's arterial system. Ultrafiltrate leaves the blood filter at the ultrafiltrate port through an ultrafiltrate catheter.

[0012] Document US56330946 discloses a method for removing leukocytes from blood in an extracorporeal circuit. The method involves passing blood containing leukocytes from a patient into a container, allowing a portion of the biofluid to pass from the container through a recirculation circuit. The recirculation circuit includes a filter assembly for removing leukocytes and transferring a portion of the blood containing depleted leukocytes into the container; transferring additional blood containing leukocytes from the patient into the container, such that the additional blood mixes with the blood containing depleted leukocytes in the container to provide a mixture; and subsequently sending a portion of the mixture to the patient while allowing another portion of the mixture to pass through the recirculation circuit.

[0013] The purpose of this disclosure is to provide a disposable circuit for extracorporeal blood processing, which is particularly suitable for critical care and also suitable for chronic care applications, and facilitates the rapid and safe temporary disconnection of the patient from the device during the execution of blood processing.

[0014] Furthermore, the purpose of embodiments of this disclosure is to provide a disposable circuit for extracorporeal blood processing that is economically convenient to use.

[0015] Another object of embodiments of this disclosure is a disposable circuit for extracorporeal blood processing that prevents erroneous fluid dispensing of fluid that remains in the device while the patient is temporarily disconnected from the device.

[0016] Another object of embodiments of this disclosure is a disposable circuit for extracorporeal blood processing that allows a patient to be safely reconnected to the device and, when the patient’s circulatory device is reconnected to the processing machine, safely reintroduces fluid and / or blood still present in the device into the patient’s circulatory device.

[0017] Another object of embodiments of this disclosure is to provide a disposable circuit that, when a patient is disconnected from the device, can be configured to prevent retention and / or reduce the risk of blood clotting still present therein. Summary of the Invention

[0018] At least one of the above objectives is achieved essentially through a one-time loop according to the following aspects.

[0019] The one-time circuit is disclosed according to the following aspects, and it can be combined in any combination where possible. Therefore, the dependence of the aspects should not be considered strictly limiting.

[0020] According to the first aspect, this document discloses a disposable circuit for extracorporeal blood processing, comprising: - The filter unit (2) has a primary chamber (3) and a secondary chamber (4) separated by a semipermeable membrane (5); - A blood circuit (6, 7) comprising a blood extraction line (6) having a first end connected to an inlet of the filter unit (2), particularly the inlet of the primary chamber (3), and a blood return line (7) having a first end connected to an outlet of the filter unit (2), particularly the outlet of the primary chamber (3), the blood extraction line (6) and the blood return line (7) being designed to connect to the patient's cardiovascular system. The blood extraction line (6) has a second end with an arterial connector (40), and the blood return line (7) has a second end with a venous connector (41), the arterial connector (40) and the venous connector (41) being designed to be detachably connected to the patient's vascular access device; and the blood circuit is configured to interface with a blood pump (11) for controlling the flow in the blood circuit (6, 7); - Optionally, the discharge fluid line (13) is connected to the outlet of the secondary chamber (4); - At least one fluid line (15, 21, 25, 42; 42a) is connected to the blood circuit (6, 7), and the disposable circuit further includes at least one first auxiliary connector (51, 53, 55, 57, 59) disposed on the blood circuit (6, 7) or disposed on the at least one fluid line (15, 21, 25, 42; 42a), the at least one first auxiliary connector (51, 53, 55, 57, 59) being configured to be removably connected in a recirculation configuration to at least one connector between the arterial connector (40) and the venous connector (41) to define a closed loop that allows fluid recirculation in the blood circuit; The disposable circuit may optionally further include a second auxiliary connector (50, 52, 54, 56, 58) disposed on the blood circuit or the at least one fluid line (15, 21, 25, 42; 42a), wherein the first auxiliary connector (51, 53, 55, 57, 59) and the second auxiliary connector (50, 52, 54, 56, 58) are configured such that one is removably connected to the arterial connector (40) and the other is removably connected to the venous connector (41) to define the closed circuit.

[0021] The first aspect relates, for example, but not limited to, an apparatus for performing dialysis treatments (such as HF and HDF) and treatments including regional anticoagulation or hemoperfusion treatments utilizing fluid infusion. Furthermore, the first aspect may also relate to a configuration for ECCO2R infusion, i.e., using an oxygenator placed in a blood line to remove excess CO2 from the blood.

[0022] According to another independent aspect, a disposable circuit for extracorporeal blood processing includes: - Filtering unit (2); - A blood circuit (6, 7) includes a blood extraction line (6) having a first end connected to an inlet of a filter unit (2) and a blood return line (7) having a first end connected to an outlet of the filter unit (2), the blood extraction line (6) and the blood return line (7) being designed to connect to a patient's cardiovascular system. The blood extraction line (6) has a second end with an arterial connector (40), and the blood return line (7) has a second end with a venous connector (41), the arterial connector (40) and the venous connector (41) being designed to be detachably connected to the patient's vascular access device; and the blood circuit is configured to interface with a blood pump (11) for controlling the flow in the blood circuit (6, 7); - At least one first auxiliary connector (51, 53, 55, 57, 59) is disposed on the blood circuit (6, 7), said at least one first auxiliary connector (51, 53, 55, 57, 59) being configured to be removably connected to at least one connector between the arterial connector (40) and the venous connector (41) in a recirculation configuration in order to define a closed loop that allows fluid recirculation in the blood circuit; The disposable circuit may optionally further include a second auxiliary connector (50, 52, 54, 56, 58) disposed on the blood circuit, wherein the first auxiliary connector (51, 53, 55, 57, 59) and the second auxiliary connector (50, 52, 54, 56, 58) are configured such that one is removably connected to the arterial connector (40) and the other is removably connected to the venous connector (41) to define the closed circuit.

[0023] This additional aspect relates, for example, to (but is not limited to) an apparatus for performing dialysis procedures (such as HD) without infusion into a blood circuit or for performing non-infusion hemoperfusion procedures. Furthermore, this aspect may also relate to a configuration of a non-infusion ECCO2R, i.e., using an oxygenator placed in the blood tubing to remove excess CO2 from the blood.

[0024] According to another aspect belonging to the foregoing, the disposable circuit can be reversibly configured between a processing configuration and a recirculation configuration, in which the arterial connector (40) and the venous connector (41) are removably connected to the patient's vascular access device and blood can be drawn from the patient through the blood extraction line (6), circulated through the filter unit (2) and returned to the patient through the blood return line (7), in which one of the arterial connector (40) and the venous connector (41) is removably connected to one of the first auxiliary connectors (51, 53, 55, 57, 59) and the 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), wherein, in the recirculation configuration, the fluid contained in the blood circuit (6, 7) can be recirculated within the disposable circuit.

[0025] According to the second aspect which is subordinate to any of the foregoing aspects, the first auxiliary connector (51, 53, 55, 57, 59), and optionally both the first auxiliary connector (51, 53, 55, 57, 59) and the second auxiliary connector (50, 52, 54, 56, 58), are provided with at least one disconnectable port (70; 70a), said at least one disconnectable port being configured to connect to a corresponding disconnectable port (72) of the vein connector (41) or the artery connector (40).

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

[0027] According to the third aspect subordinate to aspect 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 a three-port connector, and optionally both the first auxiliary connector (51, 53, 55, 57, 59) and the second auxiliary connector (50, 52, 54, 56, 58) are three-port connectors, the three-port connectors having a disconnectable port (70) configured to connect to a disconnectable port (72) of a vein connector (41) or an artery connector (40).

[0028] According to the fourth aspect, which is subordinate to one or more of aspects 1 to 2, the first auxiliary connector (51, 53, 55, 57, 59) is a four-port connector provided with a first disconnectable port (70) and a second disconnectable port (70a), each of the first disconnectable port and the second disconnectable port being configured to connect to a corresponding disconnectable port (72) of the vein connector (41) or the artery connector (40).

[0029] According to the fifth aspect, which is subordinate to any one of aspect 2, 3, or 4, 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 optionally provided with: - Fixed to a first non-disconnectable maintenance port (71) of the pipe section, optionally, fixed to a first non-disconnectable maintenance port (71) and a second non-disconnectable maintenance port (71) of the corresponding pipe section. - The at least one disconnectable port (70).

[0030] According to the sixth aspect subordinate to aspect 4, the first auxiliary connector (51, 53, 55, 57, 59) is provided with a first non-disconnectable maintenance port (71) and a second non-disconnectable maintenance port (71) fixed to the pipe portion, the first disconnectable port (70) and the second disconnectable port (70a), wherein the first non-disconnectable maintenance port (71) and the second non-disconnectable maintenance port (71) fixed to the corresponding pipe portion are configured to be non-removably connected to the corresponding portion of the fluid line (15, 21, 25, 42; 42a) fixed with the first auxiliary connector.

[0031] According to the seventh aspect, which is subordinate 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 having said disconnectable port (70) configured to be detachably connected to an arterial connector (40) or a venous connector (41).

[0032] According to the eighth aspect, which is subordinate 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” type connector, and / or a Luer type connector, and / or a self-sealing connector, wherein at least its first disconnectable port (70) is configured to automatically seal when disconnected from another connector to prevent fluid leakage, and to automatically open when connected to the venous connector (41) or the arterial connector (40) to allow fluid passage.

[0033] According to the ninth aspect, which belongs to one or more of the foregoing aspects: - The at least one disconnectable port (70; 70a) of the at least one first auxiliary connector (51, 53, 55, 57, 59) and the at least one disconnectable port (72) of the arterial connector (40) or the venous connector (41) may be a first convex shape or a second concave shape, wherein the first convex shape is configured to be at least partially introduced into the second concave shape; - Both the artery connector (40) and the vein connector (41) are connectors provided with a first-type disconnectable port (72), or alternatively, - Both the arterial connector (40) and the venous connector (41) are provided with a second type of disconnectable port (72).

[0034] According to the tenth aspect which is subordinate to aspect 9: - 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) that is either convex or concave.

[0035] According to aspect 11, which is subordinate to one or more of the foregoing aspects, the one or more fluid lines (15, 21, 25; 42; 42a) are directly connected to the blood circuit, optionally via an intervening non-disconnectable connector, preferably a tee connector.

[0036] According to the 12th aspect, which is subordinate to one or more of the foregoing aspects, the one or more fluid lines (15, 21, 25; 42; 42a) include one or more of the following lines: - The post-blood pump pre-dilution infusion line (15) is directly connected to the blood extraction line (6). - Pre-blood pump pre-dilution infusion line (21) is directly connected to blood extraction line (6). - The post-dilution fluid line (25) is directly connected to the blood return line (7).

[0037] According to the 13th aspect, which is subordinate to one or more of the foregoing aspects, the first auxiliary connectors (51, 53, 55, 57, 59) are arranged on the blood circuit (6, 7).

[0038] According to aspect 14, which is subordinate to one or more of the foregoing aspects, a first auxiliary connector (51, 53, 55) is arranged on the blood extraction tubing (6).

[0039] According to aspect 15, which is subordinate to one or more of aspects 1 to 13 above, a first auxiliary connector (57, 59) is arranged on the blood return line (7).

[0040] According to aspect 16, which is subordinate to one or more of aspects 1 to 12 above, a first auxiliary connector (51) is arranged on the post-blood pump pre-dilution infusion line (15).

[0041] According to aspect 17, which is subordinate to one or more of aspects 1 to 12 above, a first auxiliary connector (53) is arranged on the pre-blood pump pre-dilution infusion line (21).

[0042] According to aspect 18, which is subordinate to one or more of aspects 1 to 12 above, a first auxiliary connector (57) is arranged on the post-dilution fluid line (25).

[0043] According to aspect 19, which is subordinate to one or more of the foregoing aspects, a second auxiliary connector (50, 52, 54, 56, 58) is arranged on the blood circuit (6, 7).

[0044] According to aspect 20, which is subordinate to one or more of the foregoing aspects, a second auxiliary connector (50, 52, 54, 58) is arranged on the blood extraction tubing (6).

[0045] According to aspect 21, which is subordinate to one or more of the foregoing aspects, a second auxiliary connector (50, 52, 54, 56, 58) is arranged on the blood return line (7).

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

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

[0048] According to aspect 24, which is subordinate to one or more of aspects 1 to 18 above, a second auxiliary connector (56) is arranged on the post-dilution fluid line (25).

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

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

[0051] According to aspect 27, which is subordinate to one or more of aspects 1 to 12 above, the first auxiliary connector and the second auxiliary connector are arranged in the post-dilution fluid line (25).

[0052] According to one or more of the aforementioned aspects 1 to 12, a first auxiliary connector and a second auxiliary connector are arranged on the blood circuit, for example, the first auxiliary connector is arranged on the blood extraction line and the second auxiliary connector is arranged on the blood return line, or alternatively, both auxiliary connectors are placed on the blood extraction line (6).

[0053] According to aspect 28, which is subordinate to one or more of the foregoing aspects, at least one fluid line (15, 21, 25, 42; 42a) connected to the blood circuit includes at least one auxiliary line (42, 42a).

[0054] According to aspect 29, which is subordinate to one or more of aspects 1 to 12 and 28 above, a first auxiliary connector (55) is arranged on the at least one auxiliary conduit (42, 42a).

[0055] According to aspect 30, which is subordinate to one or more of aspects 1 to 12 and 28 or 29 above, a second auxiliary connector (54) is arranged on the at least one auxiliary conduit (42, 42a).

[0056] According to aspect 31, which is subordinate to one or more of aspects 28 to 30 above, the first auxiliary connector and the second auxiliary connector are mounted on the same, single auxiliary conduit (42); the auxiliary fluid conduit (42) may optionally have its own dedicated fluid pump conduit on which the fluid pump operates; optionally, one of the first auxiliary connector and the second auxiliary connector is mounted upstream of the other auxiliary connector.

[0057] According to aspect 32, which is subordinate to one or more of aspects 1 to 31 above, a blood pump conduit configured to receive the action of a blood pump (11) has an inlet port and an outlet port, and wherein the extraction conduit (6) includes a first portion (6a) located upstream of the inlet port of the blood pump conduit and downstream of the arterial connector (40) and a second portion located downstream of the outlet port of the blood pump conduit and upstream of the inlet of the primary chamber (3).

[0058] According to aspect 33, which is subordinate to aspects 17 and 32, the first auxiliary connector (53) of the pre-blood pump pre-dilution infusion line (21) is provided with a port that is in direct fluid communication with the first part (6a) of the blood extraction line (6).

[0059] According to aspect 34, which is subordinate to aspect 33, the pre-blood pump pre-dilution infusion line (21) is configured to allow fluid to be dispensed to a blood circuit downstream of the arterial connector (40); the pre-blood pump pre-dilution infusion line (21) may optionally include a container containing, for example, an anticoagulant solution (e.g., citrate solution), to which the pre-blood pump pre-dilution infusion line (21) is connected.

[0060] According to aspect 35, which is subordinate to aspect 34, the fluid conduit includes: - The first auxiliary pipeline (42) may optionally be equipped with its own dedicated fluid pump. - The second auxiliary line (42a) may optionally be equipped with its own dedicated fluid pump. The first auxiliary connector is installed in the first auxiliary pipeline (42), and the second auxiliary connector is installed in the second auxiliary pipeline (42a).

[0061] According to aspect 36, which is subordinate to one or more of the foregoing aspects, the disposable circuit further includes at least one first pressure drop valve or flow resistor (60) configured to uniformly distribute fluid flow during recirculation, the at least one first pressure drop valve or flow resistor (60) being arranged on the blood circuit or the at least one fluid line (15, 21, 25, 42; 42a), the at least one first pressure drop valve or flow resistor (60) being configured to uniformly distribute fluid flow resistance between corresponding fluid flow resistances of two connected branch sections during recirculation.

[0062] According to aspect 37, which is subordinate to aspect 36, the at least one first pressure drop valve or flow resistor (60) is arranged in one of the two connected branch pipe sections; optionally, the two connected branch pipe sections include at least a portion of the fluid line (15, 21, 25, 42, 42a) and at least a portion of the blood circuit (6, 7).

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

[0064] Here, downstream is relative to the direction of fluid infusion during the pre-infusion of the replacement fluid during processing. Specifically, the first pressure drop valve or flow resistor (60) is downstream of the first auxiliary connector and the second auxiliary connector (see...). Figure 6 Place it on the post-blood pump pre-dilution infusion line (15).

[0065] According to aspect 39, which is subordinate to one or more of the foregoing aspects, at least one of the fluid lines (15, 21, 25, 42; 42a) is configured to be connected to a flow regulating actuator, in particular a fluid pump (18, 22, 27) configured to regulate the flow rate of the fluid in the respective fluid line.

[0066] According to aspect 40, which is subordinate to aspects 12 and 39: - The post-blood pump pre-dilution infusion line (15) is connected to the blood extraction line (6) and has a fluid pump 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 a blood return line, having a fluid pump 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 a blood extraction line (6), has a fluid pump section configured to be coupled to at least one pre-blood infusion pump (22) for regulating flow through the pre-blood pump infusion line.

[0067] According to the 41st aspect, which is subordinate to the 40th 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 fluid pump section of the respective infusion fluid line (15, 21, 25), and in particular, wherein the first auxiliary connector (51, 53, 55, 57, 59) and the second auxiliary connector (50, 52, 54, 56, 58) are arranged downstream of the fluid pump (18, 22, 27) of the respective fluid line (15, 21, 25).

[0068] According to aspect 42, which is subordinate to one or more of the foregoing aspects: - The first auxiliary connector (51, 53, 55, 57, 59) can be connected to the arterial connector (40), particularly through a direct connection between the ports of the first auxiliary connector (51, 53, 55, 57, 59) and the arterial connector (40), or through a portion of a conduit connecting the ports of the first auxiliary connector (51, 53, 55, 57, 59) to the arterial connector (40); and / or wherein - The second auxiliary connector (50, 52, 54, 56, 58) can be connected to the vein connector (41), in particular through a direct connection between the port of the second auxiliary connector (50, 52, 54, 56, 58) and the artery connector (40), or through a portion of the tubing connecting the port of the second auxiliary connector (50, 52, 54, 56, 58) to the vein connector (41).

[0069] According to aspect 43, which is subordinate to one or more of the foregoing aspects, the disposable circuit includes an air separator, particularly a bubble trap (8), which is placed downstream of the outlet of the primary chamber (3), in the portion of the blood return line (7) between the outlet of the primary chamber (3) and the venous connector (41), wherein at least one of the fluid lines (15, 21, 25, 42; 42a), preferably all of the fluid lines (15, 21, 25, 42; 42a), is upstream of the air separator or at the air separator, i.e., between the arterial connector (40) and the air separator, connected to the blood circuit (6, 7).

[0070] According to aspect 44, which is subordinate to one or more of the foregoing aspects, the circuit also includes a safety clip (9) that is movable on the blood return line (7) and configured to be controlled by the control unit (10); wherein at least one fluid line (15, 21, 25, 42; 42a) is positioned upstream of the safety clip (9), and optionally, wherein all fluid lines (15, 21, 25, 42; 42a) are positioned upstream of the safety clip (9) between the arterial connector (40) and the safety clip (9).

[0071] According to aspect 45, which is subordinate to aspect 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 positioned upstream of the safety clip (9), optionally wherein both the first auxiliary connector (51, 53, 55, 57, 59) and the second auxiliary connector (50, 52, 54, 56, 58) are positioned upstream of the safety clip (9).

[0072] According to aspect 46, which is subordinate to aspects 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 placed downstream of the safety clip (9) in a portion of the blood return line (7) between the outlet of the primary chamber (3) and the venous connector (41), optionally wherein the first auxiliary connector (51, 53, 55, 57, 59) is placed upstream of the safety clip (9) and the second auxiliary connector (50, 52, 54, 56, 58) is placed downstream of the safety clip (9).

[0073] According to aspect 47, which is subordinate to aspect 12, the disposable circuit further includes at least one infusion fluid container (16, 23, 26) connected to the inlet of the post-blood pump pre-dilution line (15), the inlet of the post-dilution fluid line (25), or the inlet of the pre-blood pump infusion line (21), optionally including a first infusion fluid container (16) connected to the inlet of the post-blood pump pre-dilution line (15), a second infusion fluid container (26) connected to the inlet of the post-dilution fluid line (25), and a third infusion fluid container (23) connected to the inlet of the pre-blood pump pre-dilution infusion line (21).

[0074] According to aspect 48, which is subordinate to any of the aforementioned aspects when subordinate to aspect 43, a disposable circuit is docked with a bubble sensor (8a) configured to detect the presence of one or more bubbles in the blood circuit (6, 7); the bubble sensor (8a) is configured to be operatively connected to the control unit (10) and to send a predetermined signal to the control unit (10) in the event that at least one or more bubbles are detected in the blood circuit (6, 7).

[0075] According to aspect 49, which is subordinate to aspects 44 and 48, the bubble sensor (8a) is associated with or connected to the portion of the blood return line (7) between the bubble trap (8) and the clamp (9); Specifically, the bubble sensor (8a) is configured to send a predetermined signal to the control unit (10) upon detection of at least one or more bubbles, so as to cause the clamp (9) to close.

[0076] According to one or more of the foregoing aspects, a disposable circuit is a CRRT disposable circuit in a device for extracorporeal blood processing in an acute setting.

[0077] According to one or more of the foregoing aspects, a disposable circuit is a CRRT disposable circuit, which includes a disposable dialysis fluid line (19) that is non-removably connected to the inlet of the secondary chamber (4) and a disposable discharge line (13) that is non-removably connected to the outlet of the secondary chamber (4).

[0078] According to aspect 50, which is subordinate to one or more of the foregoing aspects, the primary circuit also includes a dialysis fluid line (19) connected to the inlet of the secondary chamber (4).

[0079] According to aspect 51, which is subordinate to aspect 50, the disposable circuit also includes a dialysis fluid container (20) disposed at the end of the dialysis fluid line (19) and configured to deliver the fluid contained therein to the inlet of the secondary chamber (4); Optionally, among which: - The disposable circuit also includes a dialysate pump line placed on the dialysate line (19), and the dialysate pump (17a) operates on the dialysate line to force fluid from the dialysate container (20) to the inlet of the secondary chamber (4).

[0080] According to aspect 52, which is subordinate to aspect 50 or 51, a discharge fluid container (14) is also included, which is disposed at the end of the discharge fluid line (13) and configured to collect fluid extracted from the outlet of the secondary chamber (4). The disposable circuit may optionally also include a discharge liquid pump conduit placed on a discharge fluid line (13) and a discharge liquid pump (17) provided on the discharge fluid line to force fluid from the outlet of the secondary chamber (4) to the discharge fluid container (14).

[0081] According to aspect 53, which is subordinate to one or more of the foregoing aspects, in the recirculation configuration, fluid flows from the arterial connector (40) through the primary chamber (3) to the venous connector (41), or from the second end of the blood extraction line (6) to the first end of the blood extraction 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 aspect 54, which is subordinate to one or more of the foregoing aspects, the at least one infusion fluid line (15, 21, 25, 42; 42a) includes a first end connected to, in particular directly connected to, a blood circuit (6, 7) and a second end opposite to the first end, the disposable circuit including a processing configuration different from the recirculation configuration, wherein extracorporeal blood processing is performed in the processing configuration; in the processing configuration, fluid flows from the second end to the first end in the at least one infusion fluid line (15, 21, 25, 42; 42a).

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

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

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

[0086] According to aspect 58, which is subordinate to aspects 12 and 17, in the recirculation configuration, a first auxiliary connector (53) disposed on the pre-blood pump pre-dilution infusion line (21) is connected to the venous connector (41), and a second auxiliary connector (50) disposed on the pre-blood pump pre-dilution infusion line (21) is connected to the arterial connector (40).

[0087] According to aspect 59, which is subordinate to aspects 12 and 18, in the recirculation configuration, a first auxiliary connector (57) disposed on the post-dilution fluid line (25) is connected to the arterial connector (40), and a second auxiliary connector (56) disposed on the post-dilution fluid line (25) is connected to the venous connector (41).

[0088] According to aspect 60, which is subordinate to aspects 12 and 18, in the recirculation configuration, a first auxiliary connector (57) disposed on the post-dilution fluid line (25) is connected to the venous connector (41), and a second auxiliary connector (56) disposed on the post-dilution fluid line (25) is connected to the arterial connector (40).

[0089] According to aspect 61, which is subordinate to aspects 12, 15 and 20 or 21, in the recirculation configuration, a first auxiliary connector (59) disposed on the blood circuit (6, 7), particularly on the blood return line (7), is connected to the arterial connector (40), and a second auxiliary connector (58) disposed on the blood circuit (6, 7), particularly on the blood extraction line (6), is connected to the venous connector (41).

[0090] According to aspect 62, which is subordinate to aspects 12 and 59 or aspects 12 and 60, the at least one first pressure drop valve or flow resistor (60) is arranged on the post-dilution fluid line (25).

[0091] According to aspect 63, which is subordinate to aspects 12 and 55 or aspects 12 and 56, the 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 the second of the 63rd aspect, which is subordinate to aspect 12 and 57 or aspect 12 and 58, the at least one first pressure drop valve or flow resistor (60) is arranged on the pre-blood pump pre-dilution infusion line (21).

[0093] According to aspect 64, which is subordinate to one or more of the foregoing aspects, the disposable circuit includes at least one sensor for determining the flow rate of fluid (e.g., blood) in at least the blood circuit (6, 7).

[0094] According to one or more of the foregoing 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 piece (e.g., a connector with four channels, two of which are non-removably connected to the respective tube portions, and the remaining two are used to connect to the first auxiliary connector and the second auxiliary connector, respectively).

[0095] In aspect 65, according to the invention, the use of a disposable circuit according to one or more of aspects 1 to 64 in an apparatus for extracorporeal blood processing for chronic patients is disclosed herein.

[0096] In aspect 66, according to the present invention, the use of a disposable circuit according to one or more of the preceding claims in an apparatus for extracorporeal blood processing in acute patients is disclosed.

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

[0098] In aspect 67, a device is provided 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 blood flow in said blood circuit (6, 7). The control unit (10) is configured as follows: - Stop the blood pump before the patient disconnects (11); - Receives a command to initiate fluid recirculation in the blood circuit (6, 7); - When the disposable circuit is in recirculation configuration, at least the blood pump (11) is activated to recirculate the fluid inside the blood circuit (6, 7).

[0099] According to aspect 68, which is subordinate to aspect 67, the apparatus further includes at least one flow regulating actuator, in particular a fluid pump (18, 22, 27) for at least one of the infusion lines (15, 21, 25), optionally wherein one or more of the following lines are present: - A post-blood pump pre-dilution infusion line (15) is connected to a blood extraction line (6), and the device includes at least one infusion pump (18) for regulating the flow of fluid through the post-blood pump pre-dilution infusion line (15); - A post-dilution fluid line (25) is connected to a blood return line, and the device includes 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) is connected to a blood extraction line (6), and the device includes at least one pre-blood infusion pump (22) for regulating the flow through the pre-blood pump pre-dilution infusion line (21).

[0100] According to the second of the 68th aspect, which is subordinate to aspect 67, in the recirculation configuration, the first auxiliary connector (51, 53, 55, 57, 59) is directly connected to the arterial connector (40) or the venous connector (41), and the second auxiliary connector (50, 52, 54, 56, 58) is directly connected to another of the arterial connector (40) and the venous connector (41). The control unit (10) is configured to maintain the disposable loop in the recirculation configuration, wherein, during recirculation, the full flow rate of the fluid 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 the two partial flow rates of the fluid 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 the full flow rate.

[0101] According to aspect 69, which is subordinate 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 fluid line (25), the pre-blood infusion pump (22) of the post-blood pump pre-dilution infusion line (21), the dialysis pump (21), and the draining fluid pump (17) is a peristaltic pump fixedly mounted on the device, and its actuator is configured to force fluid to move to the pump line of the corresponding line by direct action, specifically compression.

[0102] According to one or more of aspects 67 to 69 and aspect 70 of aspect 47, the device also includes at least one scale selected from the group consisting of: - A first scale (34) operable to provide weight information related to the amount of fluid supplied from the first infusion fluid container (16); - A second scale (36) operable to provide weight information related to the amount of fluid supplied from the second infusion fluid container (23); - A third scale (37) operable to provide weight information related to the amount of fluid supplied from the third infusion fluid container (26); - Discharge scale (33), operable to provide weight information related to the amount of fluid collected in discharge fluid container (14); - Dialysis scale (20), operable to provide weight information related to the amount of fluid supplied by the dialysis fluid container (20).

[0103] According to a 71st aspect belonging to one or more of aspects 67 to 70, the device further includes a control unit (10) comprising at least one first operating configuration of the blood, wherein the control unit is configured to: - Receive or calculate an initial value for one or more fluid flow rates selected from the group including: fluid flow rate (Q) through the discharge line (13). eff The fluid flow rate (Q) through at least one of the infusion fluid lines (15, 21, 25, 42; 42a), optionally through any one of the post-blood pump pre-dilution infusion line (15), the pre-blood pump pre-dilution infusion line (21), and the post-dilution fluid line (25) pre Q pbp Q post ), the fluid flow rate (Q) through the dialysis fluid line (19) dial ), fluid removal rate from the patient (Q pfr ), blood flow velocity (Q) b ).

[0104] According to aspect 72, which is subordinate to aspect 71, the control unit (10) is configured to actuate at least one of the following: blood pump (11), infusion pump (18) of post-blood pump pre-dilution infusion line (15), infusion pump (27) of post-dilution fluid line (25), pre-blood infusion pump (22) of pre-blood pump pre-dilution infusion line (21), dialysis pump (17a), and discharge liquid pump (17) to deliver a prescribed or calculated flow rate.

[0105] According to aspect 73, which is subordinate to aspects 71 or 72 and 68, the control unit (10) includes a second operating configuration, which includes: - Receives a command to initiate temporary fluid recirculation in the blood circuit (6, 7); - Set at least one value for the recirculation flow rate through the blood circuit (6, 7); - When in recirculation configuration, at least the blood pump (11) is activated to cause recirculation of fluid in the blood circuit (6, 7); - Wherein, the second operation configuration occurs after the first operation configuration is interrupted, and the flow rate of the fluid in the blood circuit (6, 7) is reduced to at least temporarily zero by disabling at least the blood pump (11), the blood pump (11) and infusion pump (18) of the optional pre-dilution fluid line (15), the infusion pump (27) of the post-dilution fluid line (25), and the pre-blood infusion pump (22) of the pre-blood pump infusion line (21).

[0106] According to aspect 74, which is subordinate to one or more of aspects 71 to 73, the control unit (10) is configured to obtain electronic confirmation that the arterial connector (40) is disconnected from the venous connector (41) before allowing the blood pump (11) to be started for recirculation.

[0107] According to aspect 75, which is subordinate to one or more of aspects 63 to 74, the device further includes a safety clip (9) fixedly arranged on the blood circuit (6, 7), the safety clip including at least one opening structure that allows fluid to flow through the blood circuit (6, 7) and a closing structure that prevents fluid from flowing through the blood circuit (6, 7), optionally wherein the safety clip (9) is an electronically controlled safety clip (9).

[0108] According to aspect 76, subordinate to one or more of aspects 72, 73, 74, when combined with aspect 75, the safety clip (9) is operatively connected to the control unit (10), wherein in a first operating configuration and a second operating configuration, the safety clip (9) receives a control signal that keeps it permanently in its open or open configuration, and wherein when switching between the first operating configuration and the second operating configuration, the safety clip (9) receives a control signal that configures it to a closed configuration.

[0109] According to aspect 77, which is subordinate to any of the foregoing aspects, in the operation / processing configuration, the 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 wherein, in the recirculation configuration, instead of the operation / processing configuration, the at least one first auxiliary connector (51, 53, 55, 57, 59) is connected to the arterial connector (40) or the venous connector (41), optionally wherein the first auxiliary connector (51, 53, 55, 57, 59) is directly connected to one of the connectors between the arterial connector (40) and 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).

[0110] According to aspect 68 and aspect 78, at least the blood pump (11), or the infusion pump (18) of the post-blood pump pre-dilution infusion line (15), or the infusion pump (27) of the post-dilution fluid 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 draining fluid pump (17) is an occluded pump, optionally a peristaltic pump.

[0111] According to aspect 79, a method for blood recirculation in a disposable circuit is disclosed herein, the disposable circuit being provided with: - Filtering unit (2); - A blood circuit (6, 7) includes a blood extraction line (6) having a first end connected to an inlet of a filter unit (2) and a blood return line (7) having a first end connected to an outlet of the filter unit (2), the blood extraction line (6) and the blood return line (7) being designed to connect to a patient's cardiovascular system. The blood extraction line (6) has a second end with an arterial connector (40), and the blood return line (7) has a second end with a venous connector (41), the arterial connector (40) and the venous connector (41) being designed to be detachably connected to the patient's vascular access; and the blood circuit is configured to interface with a blood pump (11) for controlling the flow in the blood circuit (6, 7); The method includes the following steps: - Stop the blood pump that is active in the blood circuit (11). - Disconnect the arterial connector (40) from the pathway leading to the patient's cardiovascular system; - Disconnect the venous connector (41) from the access route to the patient's cardiovascular system; - A disposable circuit is configured for recirculation by connecting 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) to the arterial connector (40) or the venous connector (41), wherein, after the connection, a closed circuit allowing fluid recirculation is defined, optionally wherein the step of configuring the disposable circuit for recirculation further includes connecting a second auxiliary connector (50, 52, 54, 56, 58) disposed on the blood circuit or on the at least one fluid line (15, 21, 25, 42; 42a) to another of the arterial connector (40) or the venous connector (41).

[0112] According to aspect 80, a method for temporarily disconnecting a patient from a device for extracorporeal blood processing is disclosed herein, the device comprising a disposable circuit having: - The filter unit (2) may optionally have a primary chamber (3) and a secondary chamber (4) separated by a semipermeable membrane (5); - A blood circuit (6, 7) includes a blood extraction line (6) having a first end connected to an inlet of a filter unit (2) connected to, for example, a primary chamber (3) and a blood return line (7) having a first end connected to an outlet of, for example, a filter unit (2) connected to, for example, a primary chamber (3), the blood extraction line (6) and the blood return line (7) being designed to connect to a patient's cardiovascular system. The blood extraction line (6) has a second end with an arterial connector (40), and the blood return line (7) has a second end with a venous connector (41), the arterial connector (40) and the venous connector (41) being designed to be detachably connected to the patient's vascular access device; and the blood circuit is configured to interface with a blood pump (11) for controlling the flow in the blood circuit (6, 7); - At least one fluid line (15, 21, 25, 42; 42a) connected to a blood circuit (6, 7), the disposable circuit further comprising at least one first auxiliary connector (51, 53, 55, 57, 59) disposed on the blood circuit (6, 7) or said 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 said at least one fluid line (15, 21, 25, 42; 42a), the method comprising: - A blood pump that has stopped operating in the blood circuit; - Disconnect the arterial connector (40) from the patient's access device; - Disconnect the venous connector (41) from the patient's access device; - Connect one of the arterial connector (40) and the venous connector (41) to the first auxiliary connector (51, 53, 55, 57, 59) to define the recirculation configuration; - Optionally, another of the arterial connector (40) and the venous connector (41) can be connected to a second auxiliary connector (50, 52, 54, 56, 58) to define a closed loop in a single-use circuit, thereby defining a recirculation configuration; - While the patient remains disconnected from the device, the blood pump is run to begin recirculating the fluid inside the closed loop.

[0113] Note that the one-time loop of aspect 80 depends on any of the aspects involving the one-time loop, such as 1 to 64.

[0114] According to aspect 80, method of configuring a disposable circuit on an apparatus for extracorporeal blood processing is disclosed herein, the method comprising: - A disposable circuit according to any of the foregoing aspects 1 to 78 is arranged on a device for blood treatment, the device having at least a blood pump (11) configured to force fluid flow to circulate at least into the primary chamber (3) of a filtration unit. This step of arranging the disposable circuit results in an operational configuration in which at least a portion of the blood circuit (6, 7) interacts with the blood pump (11) such that the first auxiliary connector (51, 53, 55, 57, 59) and the second auxiliary connector (50, 52, 54, 56, 58) are disconnected from the arterial connector (40) and the venous connector (41). - A disposable circuit is configured for recirculation by connecting a first auxiliary connector (51, 53, 55, 57, 59) disposed on the blood circuit (6, 7) or the fluid line (15, 21, 25, 42; 42a) to the arterial connector (40) or the venous connector (41), wherein, after the connection, a closed circuit allowing fluid recirculation is defined, optionally wherein the step of configuring the disposable circuit for recirculation further includes connecting a second auxiliary connector (50, 52, 54, 56, 58) disposed on the blood circuit or the fluid line (15, 21, 25, 42; 42a) to another of the arterial connector (40) or the venous connector (41).

[0115] According to aspect 81, which is subordinate to one or more of aspects 79 or 80, the method further includes: - Stop the blood pump to stop the recirculation of fluid within the closed loop; - Disconnect the arterial connector (40) or the venous connector (41) from the first auxiliary connector (51, 53, 55, 57, 59); - Optionally, the other of the arterial connector (40) and the venous connector (41) can be disconnected from the second auxiliary connector (50, 52, 54, 56, 58); - Before reconnection, both the arterial connector (40) and the venous connector (41) are reconnected to the patient's access device. The method steps are performed without altering the one-time circuit and / or without disconnecting the one-time circuit from the device.

[0116] According to a second of aspect 81, which is subordinate to one or more of aspects 79, 80, or 81, the step of arranging a one-time circuit on the device includes arranging at least a portion of the one-time circuit according to a path provided on the device's graphical user interface, optionally causing the step of arranging the one-time circuit on the device to be guided.

[0117] According to aspect 82, which is subordinate to one or more of aspects 79 to 81, at least a first auxiliary connector (51, 53, 55, 57, 59) disposed on a blood circuit (6, 7) or disposed on at least one fluid conduit (15, 21, 25, 42; 42a) is connected to the arterial connector (40) or the venous connector (41), wherein, after the connection, defining a closed circuit that allows fluid recirculation includes moving the arterial connector (40) or the venous connector (41) toward the first auxiliary connector (51, 53, 55, 57, 59).

[0118] According to aspect 83, which is subordinate to one or more of aspects 79 to 82, connecting a second auxiliary connector (50, 52, 54, 56, 58) disposed on a blood circuit or the at least one fluid line (15, 21, 25, 42; 42a) to one of the arterial connector (40) or the venous connector (41) that is not yet connected to the first auxiliary connector (51, 53, 55, 57, 59) defining the closed circuit comprises moving the arterial connector (40) or the venous connector (41) toward the second auxiliary connector (50, 52, 54, 56, 58).

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

[0120] According to aspect 84, which pertains to one or more of aspects 79 to 83, the method includes restoring at least a portion of extracorporeal blood to the patient before initiating recirculation.

[0121] According to the foregoing aspect, it is also provided to disconnect one of the connectors between the arterial connector (40) and the venous connector (41) from the patient's vascular access device (particularly the arterial connector) and to connect the disconnected connector to a bag containing physiological fluid. The method also includes activating a blood pump to restore extracorporeal blood to the patient once at least a portion of the extracorporeal blood is restored, disconnecting the connector from the bag and connecting it to a first or second auxiliary connector.

[0122] According to the former, the method includes, after blood flow is restored, disconnecting one of the arterial connector (40) and the venous connector (41) from the patient’s vascular access device (particularly the venous connector) and connecting it to the other of the first auxiliary connector and the second auxiliary connector.

[0123] According to aspect 84, the method includes activating an infusion pump on the infusion line to push fluid contained in a bag associated with the infusion line into the blood circuit while the patient remains connected to the extracorporeal blood circuit to restore blood to the patient (without drawing blood from the patient), optionally the blood pump is activated and synchronized with the infusion pump.

[0124] According to the foregoing aspect, the method includes maintaining at least one (and preferably both) of the arterial and venous connectors connected to the patient's vascular access device during blood recirculation. Alternatively, during blood recirculation, both the arterial and venous connectors are connected to the patient's vascular access device, with one connector disconnected from the vascular access device and connected to a first or second auxiliary connector, after which blood recirculation begins. More specifically, this variant uses an infusion pump and an associated solution bag (for treatment); the arterial tubing is set "immediately" in the recirculation step. This is also the benefit of this option / variation, minimizing processing steps (and the risk of contamination) without requiring an auxiliary fluid bag.

[0125] According to the two aspects mentioned above, the method includes disconnecting the venous connector from the patient's vascular access device after blood is restored, and connecting the venous connector to a first or second auxiliary connector.

[0126] According to the aforementioned three aspects, the method includes disconnecting the arterial connector from the patient's vascular access device after blood flow is restored, and connecting the arterial connector to a first or second auxiliary connector.

[0127] According to any of the foregoing aspects of aspect 84-2, a step is provided to drain the physiological fluid used during recirculation after recirculation and before treatment restarts. For example, a drain bag may be connected to a venous connector and an arterial connector may be reconnected to a patient vascular access device, a blood pump draws blood from the patient and pushes physiological fluid into the drain bag.

[0128] According to aspect 85, which is subordinate to any of aspects 79 to 84, the method further includes the step of clamping at least one corresponding tubular portion of the blood extraction and blood return tubing (6, 7), the clamping step being performed prior to the step of disconnecting the arterial connector (40) and the venous connector (41) from the patient's vascular access. The method includes the step of releasing the blood extraction and blood return tubing, the release being performed after a closed loop is defined in the recirculation configuration.

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

[0130] According to aspect 87, which is subordinate to aspect 85 or aspect 86, the clamping step includes clamping at least one portion of the blood extraction line (6) or the blood return line (7), optionally the portion of the blood extraction line (6) is clamped with a first manual clamp and the portion of the blood return line (7) is clamped with a second manual clamp.

[0131] According to aspect 88, which is subordinate to one or more of aspects 79 to 87, the disposable circuit is arranged on a device for extracorporeal circulation, and wherein at least the steps of disconnecting the arterial connector (40) and the venous connector (41) from the vascular access and configuring the disposable circuit for recirculation are performed, without removing the disposable circuit from the device for extracorporeal circulation. The method includes a 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, after the step of configuring the disposable circuit to a recirculation configuration has been performed, restarting at least the blood pump (11) of the extracorporeal circulation device.

[0132] According to aspect 89, which is subordinate to aspect 88, the steps of at least stopping the blood pump (11) and at least restarting the blood pump (11) are performed by the user’s actions, particularly on the user interface connected to the control unit (10), which manages the operation of at least the blood pump (11) and involves transmitting a stop signal to the blood pump (11) and a restart signal to the blood pump (11), respectively.

[0133] According to aspect 90, which is subordinate to aspect 88 or 89, in accordance with 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 infusion line, the dialysis pump (17a) acting on the dialysis (19) connected to the inlet of the secondary chamber (4) of the filter unit (2) and the discharge fluid pump (17) acting on the discharge line (13) connected to the outlet of the secondary chamber (4) are stopped or bypassed the filter unit.

[0134] Of course, all infusion pumps that are infused into the blood circuit (if infusion lines are present) also stop.

[0135] According to aspect 91, which is subordinate to one or more of aspects 79 to 90, both the first auxiliary connector (51, 53, 55, 57, 59) and the second auxiliary connector (50, 52, 54, 56, 58) are provided with at least one disconnectable port (70; 70a), which is configured to connect to the venous connector (41) and / or the arterial connector (40), and wherein the step of configuring the disposable circuit to a recirculation configuration includes connecting the disconnectable port (70; 70a) of the first auxiliary connector (51, 53, 55, 57, 59) to the disconnectable port (72) of the venous connector (41) or the arterial connector (40).

[0136] According to aspect 92, which is subordinate to aspect 91, the step of configuring a disposable circuit as a recirculation configuration includes connecting a disconnectable port (70; 70a) of a first auxiliary connector (51, 53, 55, 57, 59) to a disconnectable port (72) of a vein connector (41) and connecting a disconnectable port of a second auxiliary connector (50, 52, 54, 56, 58) to an artery connector (40), or vice versa, including connecting a disconnectable port (70; 70a) of a first auxiliary connector (51, 53, 55, 57, 59) to a disconnectable port (72) of an artery connector (40) and connecting a disconnectable port of a second auxiliary connector (50, 52, 54, 56, 58) to a vein connector (41).

[0137] According to aspect 93, which belongs 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 corresponding detachable ports (70) of the same type, either convex or concave; or The first auxiliary connector (51, 53, 55, 57, 59) has at least one convex detachable port (70), and the second auxiliary connector (50, 52, 54, 56, 58) has at least one concave detachable port (70); or - The first auxiliary connector (51, 53, 55, 57, 59) has at least one concave detachable port (70), and the second auxiliary connector (50, 52, 54, 56, 58) has at least one convex detachable port (70). The steps of connecting the disconnectable port (70; 70a) of the first auxiliary connector (51, 53, 55, 57, 59) to the disconnectable port (72) of the vein connector (41) and connecting the disconnectable port of the second auxiliary connector (50, 52, 54, 56, 58) to the arterial connector (40), or vice versa, connecting the disconnectable port (70; 70a) of the first auxiliary connector (51, 53, 55, 57, 59) to the disconnectable port (72) of the arterial connector (40) and connecting the disconnectable port of the second auxiliary connector (50, 52, 54, 56, 58) to the vein connector (41) determine the convex-concave connection.

[0138] According to aspect 94, which is subordinate to aspects 79 to 93, the one or more fluid lines (15, 21, 25; 42; 42a) include one or more of the following lines: - The post-blood pump pre-dilution infusion line (15) is directly connected to the blood extraction line (6). - Pre-blood pump pre-dilution infusion line (21) is directly connected to blood extraction line (6). - Post-dilution fluid line (25) is directly connected to blood return line (7); Each of the post-blood pump pre-dilution infusion line (15), the pre-blood pump pre-dilution infusion line (21), and the post-dilution fluid line (25) includes a first end directly connected to the blood circuit (6, 7) and a second end opposite to the first end, the second end being configured to be connected to or capable of being connected to the corresponding infusion fluid container (16, 23, 26), wherein, in the recirculation configuration, no fluid is drawn from the fluid container (16, 23, 26).

[0139] According to aspect 95, which is subordinate to aspects 79 to 94, the method further includes the step of arranging at least one first pressure drop valve or flow resistor (60), which is configured to uniformly distribute fluid flow during recirculation in the at least one fluid line (15, 21, 25, 42; 42a), and optionally the method includes the step of adjusting the at least one first pressure drop valve or flow resistor (60) when the primary circuit is in the recirculation configuration.

[0140] According to aspect 96, which pertains to aspects 79 to 95, the method includes connecting at least a first auxiliary connector (51, 53, 55, 57, 59) disposed on a blood circuit (6, 7) or disposed on at least one fluid line (15, 21, 25, 42; 42a) to the arterial connector (40) or the venous connector (41), and optionally connecting a second auxiliary connector (51, 53, 55, 57, 59) disposed on the blood circuit or said at least one fluid line (15, 21, 25, 42; 42a) to the arterial connector (40) or the venous connector (41). The connection of the first auxiliary connector (51, 52, 54, 56, 58) to another of the arterial connector (40) and the venous connector (41) specifically includes a direct connection between the first auxiliary connector (51, 53, 55, 57, 59) and one of the arterial connector (40) or the venous connector (41), and a direct connection between the second auxiliary connector (50, 52, 54, 56, 58) and another of the arterial connector (40) and the venous connector (41).

[0141] According to aspect 97, which is subordinate to aspect 94, in the recirculation configuration, fluid flows from the arterial connector (40) through the primary chamber (3) to the venous connector (41), or from the second end of the blood extraction line (6) to the first end of the blood extraction 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 aspect 98, which is subordinate to aspect 94, a first auxiliary connector and a second auxiliary connector (50, 51) are arranged on the post-blood pump pre-dilution infusion line (15), and wherein, in the recirculation configuration, the first auxiliary connector (51) arranged on the post-blood pump pre-dilution infusion line (15) is connected to the venous connector (41), and the second auxiliary connector (50) arranged on the post-blood pump pre-dilution infusion line (15) is connected to the arterial connector (40).

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

[0144] According to aspect 100, which is subordinate to aspect 94, a first auxiliary connector and a second auxiliary connector (52, 53) are arranged on the pre-blood pump pre-dilution infusion line (21), and wherein, 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).

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

[0146] According to aspect 102, which is subordinate to aspect 94, a first auxiliary connector and a second auxiliary connector are arranged on the post-dilution fluid line (25), and in the recirculation configuration, the first auxiliary connector (57) arranged on the post-dilution fluid line (25) is connected to the arterial connector (40), and the second auxiliary connector (56) arranged on the post-dilution fluid line (25) is connected to the venous connector (41).

[0147] According to aspect 103, which is subordinate to aspect 94, a first auxiliary connector and a second auxiliary connector are arranged on the post-dilution fluid line (25), and wherein, in the recirculation configuration, the first auxiliary connector (57) arranged on the post-dilution fluid line (25) is connected to the venous connector (41), and the second auxiliary connector (56) arranged on the post-dilution fluid line (25) is connected to the arterial connector (40).

[0148] According to aspect 104, which is subordinate to one or more of aspects 79 to 103, a first auxiliary connector and a second auxiliary connector are arranged on the blood circuit (6, 7), and wherein, in the recirculation configuration, the first auxiliary connector (59) arranged on the blood circuit (6, 7), particularly 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), particularly on the blood extraction line (6), is connected to the venous connector (41).

[0149] According to aspect 105, a computer program product stored in at least one non-transitory memory is disclosed herein, the computer program product comprising a software code portion suitable for execution by at least one data processing unit, the software code portion being configured to cause execution of at least the following: - Provide at least one first selection item on the graphical user interface for configuring the device for blood treatment in a treatment configuration, wherein, in the treatment configuration, unwanted substances are removed from the blood through blood circulation in a blood circuit (6, 7) of a disposable circuit installed on the device according to any of the foregoing aspects 1 to 78, and provide a second selection item for configuring the device for blood treatment in a recirculation configuration. - Determine the start-up and shutdown steps of the blood pump (11) set on the extracorporeal blood recirculation device and acting on the blood circuit (6, 7), wherein, after selecting the recirculation configuration, a shutdown signal is transmitted to shut down the blood pump (11). The software code portion is further configured to trigger the restart of the blood pump (11) upon receiving a confirmation command input by the user, the command corresponding to confirmation that the one-time loop is in the recirculation configuration.

[0150] According to aspect 106, which is subordinate to aspect 105, the deactivation signal is an electrical control signal transmitted from the control unit (10) of the device to the blood pump (11).

[0151] According to aspect 107, which is subordinate to aspect 106 or aspect 105, after selecting the recirculation configuration, the software code portion causes the screen of the device to display visual guidance designed to help configure the one-time loop to the recirculation configuration, and then causes the device to switch to a "waiting for confirmation" state that ends when the user enters a confirmation command.

[0152] According to aspect 108, which is subordinate to one or more of the foregoing aspects, the control unit (10) is configured to provide a selection item via a user interface for selecting at least one of a plurality of processing modes, the processing modes including hemodialysis (HD), blood filtration with pre-diluted blood filtration (HFpre), blood filtration with post-diluted blood filtration (HFpost), blood filtration with both pre-diluted and post-diluted blood filtration (HFpre-post), blood filtration with pre-diluted blood filtration (HDFpre), blood filtration with post-diluted blood filtration (HDFpost), blood filtration with both pre-diluted and post-diluted blood filtration (HDFpre-post), ultrafiltration (UF), and is configured to control the operation of at least said device according to the selected processing mode. Attached Figure Description

[0153] Various aspects of the invention are illustrated in the accompanying drawings, which are provided by way of non-limiting example, wherein: - Figure 1 A general schematic diagram of a one-time circuit according to an embodiment of the present invention is shown. - Figure 2 and Figure 3 Exemplary types of connections for these auxiliary connectors are shown when auxiliary connectors for disposable circuits according to embodiments of the present invention are arranged in a pre-blood pump pre-dilution infusion line; - Figure 4 and Figure 5 Exemplary types of connections for these auxiliary connectors are shown when auxiliary connectors for disposable circuits according to embodiments of the present invention are arranged in a post-blood pump pre-dilution infusion line; - Figure 6 A detailed and partial schematic diagram of the configuration of a one-time loop is shown; - Figure 7 and Figure 8 An exemplary type of connection for such an auxiliary connector is shown when an auxiliary connector for a disposable circuit according to an embodiment of the present invention is arranged on a post-dilution fluid line; - Figure 9 A detailed and partial schematic diagram of the configuration of a one-time loop is shown; - Figure 10 and Figure 11 This illustrates an alternative type of connection for an auxiliary connector when the auxiliary connector of a disposable circuit according to an embodiment of the invention is arranged on a blood circuit; - Figure 12 , 13 Figures 14 and 15 illustrate exemplary types of connections for such auxiliary connectors when an auxiliary connector for a one-time circuit according to an embodiment of the invention is arranged on one or two auxiliary conduits; - Figures 15 to 19 An alternative configuration of the auxiliary connector for a one-time loop is shown; - Figure 20 A flowchart illustrating some of the operational steps required for the apparatus and disposable loop object of this disclosure to switch from a processing configuration to a recirculation configuration is shown. Detailed Implementation

[0154] A non-limiting embodiment of the apparatus 1 for extracorporeal blood processing—which enables the innovative aspects of the invention—is shown in the figures. In the following description and figures, the same components are identified by the same reference numerals.

[0155] Figure 1 An apparatus 1 designed for delivering blood to a patient for extracorporeal treatment, such as for removing unwanted substances from the patient's blood, is shown.

[0156] According to other embodiments, devices for extracorporeal blood treatment via blood perfusion and / or removal of extracorporeal CO2 (ECCO2R) are also included within the scope of the present invention.

[0157] In a non-limiting embodiment, device 1 is designed to operate at least one of the following processes: hemodialysis (HD), blood filtration with pre-dilution (HFpre), blood filtration with post-dilution (HFpost), blood filtration with both pre-dilution and post-dilution (HFpre-post), blood filtration with pre-dilution (HDFpre), blood filtration with post-dilution (HDFpost), blood filtration with both pre-dilution and post-dilution (HDFpre-post), and ultrafiltration (UF). The device may alternatively provide plasma filtration.

[0158] Device 1 includes a disposable circuit for blood processing, which includes several elements identified below. For the purposes of this invention, "disposable" should mean elements intended to be discarded or disposed of in any way after use, particularly after a single use. In particular, it should be noted that "single use" refers to a single patient treatment. It should be understood that temporary disconnection of the patient from device 1 during treatment does not interrupt the single treatment; reconnection of the patient to the disposable circuit after temporary disconnection still falls within the single use as defined herein. Elements of any embodiment according to the non-limiting embodiments described below that are part of the disposable circuit are marked with bold lines in the drawings; those that are part of device 1 are marked with thin lines; this helps the reader to clearly identify which elements belong to the disposable circuit and which elements are contrasting parts of the device. The disposable circuit described below may be detachably connected to the device and may be sold or provided separately from device 1 in any way.

[0159] The disposable circuit includes a filtration unit 2, such as a blood filter, ultrafilter, hemodialysis filter, dialyzer, plasma filter, gas exchanger, adsorbent cartridge, etc.; specifically, according to... Figure 1 In a first example specifically relating to a dialysis apparatus, the filtration unit may have a primary chamber 3 and a secondary chamber 4 separated by a semipermeable membrane 5; depending on the process, the membrane of the filtration unit may be selected to have different properties and performance.

[0160] The disposable circuit includes a blood extraction 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 extraction line 6 and the blood return line 7 are connected to a vascular access device in communication with the patient's vascular system. For example, the blood extraction and return lines may be connected to a fixed catheter (e.g., a central venous catheter for acute patients) or a corresponding needle, particularly, although not limited to, a metal needle (e.g., to be inserted into an arteriovenous fistula for chronic patients) or other access device (not shown in the figures), in a first configuration of the disposable circuit described herein as an "operating configuration" or "processing configuration," which is positioned in fluid communication with the patient's vascular system such that blood can be extracted through the blood extraction line, flow through the primary chamber, and subsequently returned to the patient's vascular system through the blood return line. The blood return line 7 and the blood extraction line 6 are made of a flexible plastic material. In a non-limiting solution, the blood extraction line 6 and the blood return line 7 are made of a transparent plastic material to allow for identification of the presence of blood.

[0161] More specifically, the blood extraction line 6 includes 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 a disposable circuit and is placed downstream of the arterial access 40a that provides access to the vascular system of the patient “P”; the blood return line 7 includes 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 a disposable circuit upstream of the venous inlet 41a of the patient “P”.

[0162] In this disclosure, references to "downstream" and "upstream" will be used to indicate the position of a component relative to other components. For example... Figure 1Marked by arrow F, the normal fluid flow applied by blood pump 11 is from arterial connector 40 to venous connector 41; therefore, this flow will be considered in relation to the terms "downstream" and "upstream." Thus, in the operating configuration, fluid moves upward from arterial connector 40 through portion 6a of the blood extraction line 6 to blood pump 11, forcing flow at the inlet of primary chamber 3, and subsequently upward through filter 2 to the outlet of primary chamber 3. The fluid then moves into blood return line 7 until its second end connects to venous connector 41. For example, blood pump 11 is located upstream of primary chamber 3, and the outlet of primary chamber 3 is located downstream of the inlet of primary chamber 3 and / or blood pump 11.

[0163] Arterial connector 40 and venous connector 41 are non-disconnectable connectors. They have ports that are fixed (e.g., welded or glued) to the corresponding tubing portions (blood extraction tubing and blood return tubing), and free ports that can be detachably connected to the corresponding arterial access 40a or venous access 41a (e.g., arterial and venous needles or catheters). The free ports of the arterial and venous connectors can be convex or concave. Preferably, the free ports of both arterial and venous connectors 40 and 41 are of the same type. Figure 18 and Figure 19 A non-limiting and illustrative embodiment of an artery or vein connector is shown, wherein the free port 72 is concave ( Figure 18 ) or positive type ( Figure 19 A Luer connector is preferred. Because they are the same type of connection, the arterial connector 40 and the venous connector 41 cannot be directly connected together.

[0164] At least one air separator, such as a bubble trap 8, is present in the blood circuits 6 and 7, and preferably in the blood return line (another bubble trap may also be provided in the extraction line); in addition, a safety clip 9 of the device is movable in the blood return line and is typically positioned downstream of the bubble trap 8 and near the vein connector 41. The safety clip 9 can be controlled by the control unit 10 of the device 1. It should be noted that although the air separator and the safety clip are optional components, their presence is preferred.

[0165] Additionally, the device includes a bubble sensor 8a, which corresponds to the movement of the portion of the return tubing 7 located between the bubble trap 8 and the safety clamp 9; the bubble sensor is connected to the control unit 10 and sends a signal to the control unit upon detecting one or more bubbles; in this case, the control unit can stop processing and close the clamp 9. A corresponding safety clamp (not shown) of the device may be provided for the blood extraction tubing 6. The safety clamp is movable on the blood extraction tubing 6 immediately downstream of the artery connector 40.

[0166] like Figure 1As shown, blood flow through the blood tubing is controlled by a blood pump 11, such as a peristaltic blood pump, which acts on the blood extraction or return tubing. Blood pump 11 is a peristaltic blood pump and is part of device 1. The operator can input the blood flow rate Q through the user interface 12. B The blood flow rate is set to a predetermined value (or the device may calculate the blood flow rate based on other set parameters), and the control unit 10 is configured during processing to control the blood pump based on the set / calculated blood flow rate. Throughout this specification, the control unit is instructed to be "configured" or "programmed" to perform certain steps: this can in practice be achieved by any means that allows the control unit to be configured or programmed.

[0167] Device 1 has a (graphical) user interface configured to allow setting parameters for processing and to apply commands and controls to it in various operating configurations. The user interface may include a screen or monitor, optionally touch-sensitive, and one or more switches and / or buttons specifically configured to trigger specific operations of device 1.

[0168] The disposable circuit also includes a discharge fluid line 13, which is connected at one end to the outlet of the secondary chamber 4 and at the other end to a discharge fluid container 14 for collecting used fluid extracted from the second chamber. Alternatively, the discharge line 13 can direct the used fluid directly to a drain. The discharge fluid line is configured to interface with a discharge fluid pump 17 of the device: the discharge fluid pump 17 operates on the discharge fluid line under the control of the control unit 10 to regulate the flow rate Q through the discharge fluid line. eff .

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

[0170] According to some embodiments for emergency treatment, the disposable circuit may include the aforementioned drain fluid line 13 and dialysis fluid line 19 as a single-use component integrally fixed to the filtration unit. At the end of treatment, the entire disposable assembly is discarded. Dialysis fluid line 19 receives fresh fluid from container 20, and used dialysis fluid is delivered to drain bag 14.

[0171] Unlike other disposable items for chronic kidney disease treatment, neither the dialysis fluid tubing nor the drain fluid tubing is a disposable component. The dialysis fluid tubing and drain fluid tubing are non-disposable fluid pathways arranged into device 1. Detachable connections are provided to removably place the dialysis fluid tubing and drain fluid tubing, respectively, in fluid communication to the inlet and outlet of the secondary chamber 4 of the filtration unit; the latter is part of a disposable circuit. The dialysis fluid is a mixture of water and concentrate prepared online or received from a central dialysis fluid preparation plant.

[0172] In the context of this disclosure, the terms "upstream" and "downstream" will be used to indicate the fluid flow applied by the discharge fluid pump 17 and the dialysis pump 17a, which... Figure 1 Marked by arrow F'. When fluid enters the discharge fluid line 13 to flow at the discharge fluid pump 17 and then to the discharge fluid container 14, the discharge fluid pump 17 and the dialysis pump 17a cooperate to force fluid from the dialysis fluid container 20 through the dialysis fluid line 19 to the dialysis pump 17a, and then through the filter 2 to the inlet of the secondary chamber 4 until the outlet of the secondary chamber 4.

[0173] The dialysis fluid pump 17a and the discharge fluid pump 17 are part of a device for regulating the flow of fluid through corresponding tubing and are operatively connected to the control unit 10 that controls the pumps, as described above. The control unit 10 is also connected to a user interface 12, such as a graphical user interface, which receives operator input and displays device output. For example, the graphical user interface 12 may include a touchscreen, a display screen, and hard or soft keys, or a combination thereof, for inputting user input.

[0174] Figure 1 The illustrated disposable circuit may include an infusion line 21, which is connected at one end to a portion 6a of a blood extraction line 6 positioned upstream of the blood pump 11, and at the other end to an infusion fluid container 23, which may contain, for example, a regional anticoagulant, such as a citrate solution, or a replacement solution or other fluid. This infusion line is hereinafter referred to as the pre-blood pump pre-dilution infusion line 21. Devices for regulating fluid flow include a pump 22, such as a peristaltic pump controlled by the control unit 10, which acts on a section of the pre-blood pump pre-dilution infusion line 21 to regulate the pre-blood pump infusion rate Q. pbp Pump 22 is part of device 1.

[0175] For the purposes of this disclosure, a tee connector is a “non-disconnectable connector”, which means that in normal use, the connector is not configured to disconnect from any part of the conduit connected at any of its three ports, or equivalently, to which a part of the conduit connected at any of its three ports is fixedly engaged, for example, by coupling or sealing.

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

[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" will refer to normal fluid flow during the operational configuration. Fluid flows upward from containers 16, 23 through portions of the tubing acted upon by pumps 18, 22 of any infusion line to a non-disconnectable connector that connects the infusion line to the blood extraction line 6.

[0178] Replace or combine with pre-diluted fluid line 15 Figure 1 The device may also provide a post-dilution fluid line 25, which is connected at one end to another infusion container 26 and at the other end to a blood return line 7. Another pump 27, such as a peristaltic pump, may act on the post-dilution fluid line 25 under the control of the control unit 10, and is therefore also part of the device for regulating the flow through the fluid line.

[0179] When referring to the post-dilution fluid line 25, the terms "upstream" and "downstream" will refer to normal fluid flow during the operational configuration. Fluid flows from container 26 through the portion of the tubing acted upon by pump 27, until a non-disconnectable connector that connects the infusion line to the blood return line 7.

[0180] Replace or combine with the above-mentioned fluid piping Figure 1 The device may include one or more auxiliary lines that are connected at one end to a blood circuit, such as to a blood extraction line 6. Figure 1 A single auxiliary conduit 42 is shown. Not in Figure 1 Another pump shown, such as a peristaltic pump, can operate on the auxiliary line under the control of the control loop 10, and is therefore also part of the device for regulating the flow through the fluid line.

[0181] When referring to any auxiliary tubing, the terms “upstream” and “downstream” will refer to the normal fluid flow from the free end of the auxiliary tubing to the end connected to blood circuits 6 and 7.

[0182] The device 1 may further include: a first scale 33 operable to provide weight information about the amount of used fluid collected in the discharge fluid container 14; a second scale 34 operable to provide weight information about the amount of fluid supplied from the infusion fluid container 16 via the post-blood pump pre-dilution infusion line 15; and a third scale 35 operable to provide weight information about the amount of fluid supplied from the dialysis fluid container 20. In the presence of additional infusion lines, such as the pre-blood pump pre-dilution infusion line 21 and the post-dilution infusion line 25, corresponding scales 36 and 37 may be present to provide weight information about the amount of fluid supplied from the infusion containers 23, 26. All scales are connected to the control unit 10 and provide the weight information to the control unit 10 to determine the actual fluid volume in each container and / or the actual fluid flow rate supplied or received by each container. The control unit 10 may then be configured to receive processing selection information and check whether the user has entered the desired dialysis parameters. The control unit can also be configured to receive weight information from a first scale and, depending on the selected process, from a scale associated with a container supplied through piping involved in the delivery of the selected process, and, at least at the start of the process, to control the flow rate of at least one of the discharge fluid, infusion fluid, and dialysis fluid by controlling the regulating device based on the weight information and an initial set value.

[0183] From a structural perspective, one or more, optionally all, containers 14, 16, 20, 23, 26 may be disposable plastic containers, preferably soft plastic bags suspended on supports carried by the respective scales. Devices for regulating flow typically include pumps, although other regulating devices, such as valves or combinations of valves and pumps, may be used. Scales may include piezoelectric sensors, strain gauges, spring sensors, or any other type of transducer capable of sensing forces applied thereto. Although the examples in the figures illustrate the use of scales to determine the amount of fluid in the respective containers and allow for the calculation of the corresponding flow rates through the various tubing, it should be noted that the above aspects of the invention are also compatible with blood processing machines that use volumetric sensors to determine flow rates or combinations of mass and volumetric sensors.

[0184] While the foregoing description primarily relates to dialysis devices, embodiments of this disclosure also include hemoperfusion. Hemoperfusion is a method of filtering blood in vitro to remove one or more toxins. As with other in vitro methods, blood travels from the patient into a blood extraction line 6, is filtered in a filtration unit 2, and then typically travels back into the patient via a blood return line 7 through a venous access. In hemoperfusion, the blood is perfused by a filter composed of artificial cells filled with activated charcoal or another microporous material. In a hemoperfusion device, an infusion line may be absent. In this case, a first auxiliary connector and a second auxiliary connector are placed on the blood line, for example, in the location disclosed below according to the fourth embodiment. As a possible alternative hemoperfusion configuration, a pre-blood pump pre-infusion line may be included for injecting 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 be maintained on the blood circuit (or one connector may be placed on the pre-blood pump pre-infusion line while the other is placed on the blood line).

[0185] Furthermore, the device in the embodiment may be (alternatively or additionally) an extracorporeal CO2 removal (ECCO2R) device; the blood tubing loop may be connected to the CO2 removal filter unit 2, and the device may or may not include any infusion tubing. In the absence of an infusion tubing, the first auxiliary connector and the second auxiliary connector may be placed on the blood loop, or on either the blood loop or the infusion tubing (if present).

[0186] The disposable circuit of this disclosure is designed to allow temporary disconnection, followed by reconnection of the patient to the same disposable circuit to continue the (temporarily) interrupted treatment. To achieve this, the disposable components can be reconfigured to allow fluid (e.g., blood) to recirculate primarily within the blood circuit. Alternative to the above-described treatment (operation) configuration, another configuration of the disposable circuit described herein is referred to herein as a "recirculation configuration." In this configuration, the patient is disconnected from the disposable circuit, and the fluid present therein can be recirculated to allow the patient to be removed from the extracorporeal blood treatment device. Due to this aspect, the patient can be temporarily disconnected from device 1 to perform or undergo other examinations or treatments while pausing treatment performed using device 1 in a very easy manner, without the need for an expensive complete replacement of the disposable circuit and with reduced health risks associated with disconnect-recirculation-reconnection operations. Furthermore, no additional components are required to achieve temporary disconnection, such as additional "Y" connectors, saline bags, etc. The ability to easily switch or reconfigure between the operation configuration and the recirculation configuration further facilitates the activities of a qualified operator assisting the patient throughout the treatment. During recirculation, i.e., after the control unit 10 has been properly configured for recirculation, the target average values ​​of flow rate and / or prescribed dose are interrupted, and the average values ​​that may have been calculated and / or measured by the control unit 10 or any sensors operatively connected to it are preferably stored in memory. When the control unit 10 is properly configured to re-establish the original operating configuration for blood processing, the calculation and / or measurement resumes at the end of the patient's temporary disconnection; alternatively, although preferably, the control unit 10 may be configured to allow the calculation and / or measurement of partial values ​​before and after the re-establishment of the operating configuration.

[0187] For this purpose, several embodiments of the disposable circuit have been envisioned, comprising a first auxiliary connector and a second auxiliary connector, wherein, in a recirculation configuration, one auxiliary connector is connected to the venous connector 40 and the other auxiliary connector is connected to the arterial connector 41, to define a suitable closed circuit allowing fluid recirculation under the action of the blood pump 11. Although two auxiliary connectors are always disclosed in the detailed disclosure of the embodiments, in principle, at least one auxiliary connector may be sufficient to create a closed circuit. In practice, although not preferred, one blood line end (venous or arterial connector) can be connected to the first auxiliary connector, and the other blood line end can be left as a dead end (the second blood line end, i.e., the dead end, is simply clamped). The fluid within the closed circuit can then be recirculated. Preferably, saline or other alternative fluid should be recirculated (i.e., not blood).

[0188] Preferably, but not in a limiting sense, the auxiliary connector is a tee connector having a main inlet and a main outlet receiver for the main pipeline, wherein the auxiliary connector is positioned at the main inlet and main outlet receivers of the main pipeline and has at least one disconnectable port, which can be sealed by a cap, or alternatively, the at least one disconnectable port can be self-sealing. The latter type is such that the port automatically seals when another connector is disconnected from the disconnectable port of the auxiliary connector, and automatically opens when another connector is connected to the disconnectable port of the auxiliary connector. The self-sealing auxiliary connector helps prevent unwanted fluid (especially blood) leakage when patient care is interrupted and the configuration of the disposable circuit switches between an operating configuration and a recirculation configuration, reduces the risk of air bubbles in the blood circuit, and further facilitates operations performed by a qualified operator assisting the patient.

[0189] The auxiliary connector can have various shapes and may be provided with at least one first port or even a second detachable and free port, which can be used to connect the auxiliary connector to another auxiliary connector and / or to another of the vein and artery connectors. Non-limiting configurations of the connectors according to this disclosure include, for example, "T"-shaped connectors (… Figure 15 ( ) T-junction auxiliary connector.

[0190] The connector shown (which is a first or second auxiliary connector) includes a first non-disconnectable service port 71 and a second non-disconnectable service port 71 secured (e.g., sealed) to a corresponding flexible tubing section. For example, the tubing section could be a corresponding section of a pre-blood pump pre-dilution tubing 21; alternatively, the tubing section could be a corresponding section of any other infusion tubing or a blood extraction or return tubing. The disconnectable port 72, shown only schematically, could be a convex (or concave) Luer connector configured to engage with a corresponding concave (or convex) Luer connector 40, 41 of the blood extraction tubing 6 or the blood return tubing 7. Obviously, a Y-shaped connector, a half-snowflake connector, or another connector with a different geometry could be used.

[0191] See Figure 16 The first and second auxiliary connectors can be made as a single piece, wherein the first non-disconnectable service port 71 and the second non-disconnectable service port 71 remain fixed (e.g., sealed) to the corresponding flexible tube portions, but the combined connector includes two disconnectable ports 70, 70a for receiving the extraction tube connector 40 and the return tube connector 41, respectively. Furthermore, in this design, if the extraction tube connector 40 and the return tube connector 41 are Luer convex connectors, then the two disconnectable ports 70 are Luer concave connectors, and vice versa.

[0192] The geometry of an "integrated" connector can also vary, such as... Figure 17 In one embodiment, the two disconnectable ports 70 are presented parallel to each other on the same lateral side of the device.

[0193] Figure 1 The main and non-limiting embodiments conceived by the inventors are presented in a single schematic diagram, which are further described in detail herein.

[0194] First Embodiment

[0195] In the first embodiment, a first auxiliary connector 53 and a second auxiliary connector 52 are arranged on the pre-blood pump pre-dilution infusion line 21, within a portion of the catheter, which is located downstream of the pump 22 arranged on the pre-blood pump pre-dilution infusion line 21 once the disposable circuit is properly installed on the device 1. The first auxiliary connector 53 is arranged downstream of the second auxiliary connector 52.

[0196] In a recycle configuration, alternatively: - 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. Figure 2 );or - The first auxiliary connector 53 is connected to the vein connector 41, and the second auxiliary connector 52 is connected to the artery connector 40. Figure 3 ).

[0197] exist Figure 2 In the recirculation configuration, a full flow rate (double arrow) exists in the blood extraction line 6 downstream of the pre-blood pump pre-dilution infusion line 21 and in the blood return line 7; the full flow rate reaches the second auxiliary connector 52, where it is divided into partial flow rates (single arrow). These partial flow rates exist in multiple sections of the line connecting the second auxiliary connector 52 to the first auxiliary connector 53, and subsequently in a section of the line connecting the arterial connector 40 to the injection point of the pre-blood pump pre-dilution infusion line 21 in the blood extraction line 6. Here, these two partial flow rates merge again to form the full flow rate.

[0198] exist Figure 2 and Figure 3 In the diagram, double arrows indicate the overall flow velocity and its direction along the pipe; single arrows indicate the branch (local) flow velocity and its direction along the pipe section. The same representation is used for all diagrams showing recirculation.

[0199] In the first embodiment, both the first auxiliary connector and the second auxiliary connector are tee connectors, each having a disconnectable port 70. This disconnectable port is configured to connect to the disconnectable port 72 of a connector selected between the vein connector 40 and the artery connector 41, according to one of the two possible alternatives described above. The type of the disconnectable port 72 of the first auxiliary connector and the second auxiliary connectors 53, 52 is opposite to the type of the disconnectable ports of the vein and artery connectors. In other words, when the disconnectable port 72 of the first auxiliary connector and the second auxiliary connectors 53, 52 is convex, the disconnectable ports of the artery and vein connectors are concave, and vice versa.

[0200] Second Embodiment

[0201] In the second embodiment, a first auxiliary connector 51 and a second auxiliary connector 50 are arranged on the post-blood pump pre-dilution infusion line 15, a portion of which, once the disposable circuit is properly installed on the device 1, is located downstream of the pump 18 arranged on the post-blood pump pre-dilution infusion line 15. The first auxiliary connector 51 is arranged downstream of the second auxiliary connector 50.

[0202] In a recycle configuration, alternatively: - The first auxiliary connector 51 is connected to the vein connector 41, and the second auxiliary connector 50 is connected to the artery 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 ).

[0203] exist Figure 4 In the recirculation configuration, there is a full flow rate upstream of the post-blood pump pre-dilution infusion line 15 in the blood extraction line 6, and the full flow rate is shunted at the injection point of line 15. A partial flow rate exists in the blood return line 7 in the venous connector 41 up to the first auxiliary connector 51. Here, the partial flow from the blood extraction line and the partial flow at the first auxiliary connector 50 merge, and there is a full flow rate in the section of the line that connects the first auxiliary connector 51 to the second auxiliary connector 50 up to the blood extraction line 6, as shown in the figure.

[0204] In the second embodiment, both the first auxiliary connector and the second auxiliary connectors 50 and 51 are tee connectors, each having a disconnectable port 70. This disconnectable port is configured, according to one of the two possible alternatives described above, to connect to another disconnectable port 72 of a connector selected between the vein connector 40 and the artery connector 41. The type of the disconnectable port 72 of the first auxiliary connector and the second auxiliary connectors 51 and 50 is opposite to the type of the disconnectable ports of the vein and artery connectors. In other words, when the disconnectable port 72 of the first auxiliary connector and the second auxiliary connectors 50 and 51 is convex, the disconnectable ports of the artery and vein connectors are concave, and vice versa.

[0205] like Figure 6 Optionally, as schematically disclosed, the post-blood pump pre-dilution infusion line 15 may include a pressure-drop valve or flow resistor 60, which is particularly and, to a non-limiting extent, mounted downstream of the first auxiliary connector 51, just upstream of the non-disconnectable tee connector that connects the post-blood pump pre-dilution infusion line 15 to the blood extraction line 6. The pressure-drop valve or flow resistor 60 is configured to uniform flow resistance during recirculation and may be removably or fixedly mounted on the fluid line; optionally, the pressure-drop valve or flow resistor may be of a variable resistance type. The purpose of the pressure-drop valve or flow resistor 60 is to make the resistance of corresponding sections of the line similar, so that the flow generated in each loop branch is as similar as possible.

[0206] Third Embodiment

[0207] In the third embodiment, a first auxiliary connector 57 and a second auxiliary connector 56 are arranged on the post-dilution fluid line 25, in a portion of a conduit downstream of the pump 27 arranged on the post-dilution fluid line 25 once the disposable circuit is properly installed on the device 1. The first auxiliary connector 57 is arranged downstream of the second auxiliary connector 56.

[0208] In a recycle configuration, alternatively: - The first auxiliary connector 57 is connected to the artery connector 40, and the second auxiliary connector 56 is connected to the vein connector 41. Figure 7 );or - The first auxiliary connector 57 is connected to the vein connector 41, and the second auxiliary connector 56 is connected to the artery connector 40. Figure 8 ).

[0209] exist Figure 7In the recirculation configuration, full flow exists in the blood extraction line 6 and in the portion of the blood return line 7 that exits the primary chamber 3 and reaches a non-disconnectable connector that connects the blood return line 7 to the post-dilution fluid line 25; partial flow exists in multiple portions of the line that connects the first auxiliary connector 57 to the second auxiliary connector 56 and subsequently in the portion downstream of the post-dilution fluid line 25 of the blood return line 7.

[0210] In the third embodiment, both the first and second auxiliary connectors are tee connectors, each having a disconnectable port 70 configured to connect to another disconnectable port 72 of a connector selected between the vein connector 40 and the arterial connector 41, one of the two possible alternatives described above. The type of the disconnectable port 72 of the first and second auxiliary connectors 57, 56 is opposite to the type of the disconnectable ports of the vein and arterial connectors. In other words, when the disconnectable port 72 of the first and second auxiliary connectors 57, 56 is convex, the disconnectable port of the arterial and vein connector is concave, and vice versa.

[0211] like Figure 9 Optionally, as schematically disclosed, the post-dilution fluid line 25 may include a pressure-drop valve or flow resistor 60, specifically mounted downstream of the first auxiliary connector 57, just upstream of the non-disconnectable tee connector that connects the post-dilution fluid line 25 to the blood return line 7. The pressure-drop valve or flow resistor 60 is configured to uniform flow resistance during recirculation and may be removably or permanently mounted on the fluid line; optionally, the pressure-drop valve or flow resistor may be of a variable resistance type.

[0212] Fourth embodiment

[0213] In the fourth embodiment, both the first auxiliary connector 59 and the second auxiliary connector 58 are arranged on the blood circuit, configured such that the first auxiliary connector 59 is arranged on the blood return line 7, while the second auxiliary connector 58 is arranged on the blood extraction line 6. Preferably, although not limitingly, the second auxiliary connector 58 is located on a portion 6a of the blood extraction line 6, which is upstream of the blood pump 11 once the disposable circuit is properly installed on the device 1; the first auxiliary connector 59 is preferably installed upstream of the bubble detector 8a and the safety clip 9. Thus, the first auxiliary connector 59 is arranged downstream of the second auxiliary connector 58.

[0214] exist Figure 10 In the recirculation configuration, the first auxiliary connector 59 is connected to the arterial connector 40, and the second auxiliary connector 58 is connected to the venous connector.

[0215] exist Figure 10 In the recirculation configuration, full flow rate exists in the blood extraction line 6 downstream of the second auxiliary connector 58 and upstream of the first auxiliary connector 59, specifically in the corresponding portion of the blood extraction line 6 located between the second auxiliary connector 58 and the inlet of the primary chamber 3, and in the portion of the blood return line 7 located between the outlet of the primary chamber and the first auxiliary connector 59; partial flow rate exists in the portion of the blood extraction line 6 located between the second auxiliary connector 58 and the arterial connector 40, and in the portion of the blood return line 7 located between the first auxiliary connector 59 and the venous connector 41.

[0216] In the fourth embodiment, both the first auxiliary connector and the second auxiliary connector are tee connectors, each having a disconnectable port 70 configured to connect to another disconnectable port 72 of a connector selected between the vein connector 40 and the artery connector 41. The disconnectable ports 72 of the first and second auxiliary connectors 59, 58 are of the opposite type to the disconnectable ports of the vein and artery connectors. In other words, when the disconnectable ports 72 of the first and second auxiliary connectors 59, 58 are convex, the disconnectable ports of the artery and vein connectors are concave, and vice versa.

[0217] Figure 11 An alternative connection is shown, wherein both the first auxiliary connector and the second auxiliary connector are placed on the blood extraction tubing 6, in the tubing portion 6a upstream of the blood pump 11; the venous connector 41 is directly connected to the second auxiliary connector 58; and the arterial connector 40 is directly connected to the first auxiliary connector 59, which is placed downstream of the second auxiliary connector 58. It should be noted that the latter configuration should not be considered preferred, but it can still define a closed loop that allows for the fluid recirculation desired by this disclosure in any way.

[0218] Fifth embodiment

[0219] In the fifth embodiment, both the first auxiliary connector 55 and the second auxiliary connector 54 are arranged on a single auxiliary line, which is installed, for example, in a portion of the blood extraction line 6, preferably but not limited to a portion of the blood extraction line, located upstream of the blood pump 11 once the disposable circuit is properly arranged on the device 1. In the fifth embodiment, the first auxiliary connector 55 is arranged downstream of the second auxiliary connector 54.

[0220] In a recycle configuration, alternatively: - 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. Figure 12 );or - The first auxiliary connector 55 is connected to the vein connector 41, and the second auxiliary connector 56 is connected to the artery connector 40. Figure 13 ).

[0221] exist Figure 12 In the recirculation configuration, there is full flow in the blood extraction line 6 downstream of the auxiliary line 42 and in the blood return line 7; there is partial flow in the auxiliary line 42 and in a portion of the blood extraction line 6, which is included between a non-disconnectable tee connector that connects one end of the auxiliary line 42 to the blood extraction line 6 and a second end of the blood extraction line 6 terminating at the arterial connector 40.

[0222] In the fifth embodiment, one connector between the first auxiliary connector and the second auxiliary connector is a tee connector with a detachable port 70 configured to connect to another detachable port 72 of a connector selected between the vein connector 40 and the arterial connector 41 according to one of the two possible alternatives described above. The other connector is a bidirectional connector with a detachable port and a non-detachable port fixedly mounted on the corresponding tubular portion of the auxiliary conduit 42. The type of the detachable port 72 of the first auxiliary connector and the second auxiliary connectors 55, 54 is opposite to the type of the detachable ports of the vein and arterial connectors. In other words, when the detachable port 72 of the first auxiliary connector and the second auxiliary connectors 55, 54 is convex, the detachable ports of the arterial and vein connectors are concave, and vice versa.

[0223] The fifth embodiment is similar to the first embodiment; however, a maintenance line 42 is used instead of a treatment line 21 for temporary disconnection and recirculation.

[0224] Sixth Embodiment

[0225] Figure 14 A sixth embodiment of the disposable circuit is schematically illustrated; it includes a first auxiliary line 42 and a second auxiliary line 42a disposed on a portion of the blood extraction line 6. When the disposable circuit is properly disposed on the device 1, this portion is preferably, but not limitedly, located upstream of the blood pump 11 and optionally upstream of the pre-blood pump pre-infusion line 21. Each of the first auxiliary line and the second auxiliary line 42, 42a is provided with a first end connected to the blood extraction line 6 and terminating at a second end of a corresponding first auxiliary connector 55 disposed on the first auxiliary line 42 and a second auxiliary connector 54 disposed on the second auxiliary line 42a.

[0226] In a recycle configuration, alternatively: - The first auxiliary connector 55 is connected to the vein connector 41, and the second auxiliary connector 54 is connected to the artery connector 40. Figure 15 );or - The first auxiliary connector 55 is connected to the artery connector 40, and the second auxiliary connector 56 is connected to the vein connector 41 (since it is essentially the same as...). Figure 15 The configuration is symmetrical, therefore it is not depicted in any of the accompanying drawings.

[0227] exist Figure 15 In the recirculation configuration, full flow exists in the blood extraction line 6 downstream of the second auxiliary line 42a and in the blood return line 7; partial flow exists in the first and second auxiliary lines 42, 42a and in the portion of the blood extraction line 6 including a three-way non-disconnectable connector that connects one end of the first auxiliary line 42 to an upstream end of the second auxiliary line 42a, at which the blood extraction line 6 terminates at the arterial connector 40.

[0228] In the sixth embodiment, both the first auxiliary connector and the second auxiliary connector are two-way connectors, each having a disconnectable port and a non-disconnectable port fixedly mounted on corresponding pipe portions of the respective first and second auxiliary conduits 42. The type of the disconnectable port 72 of the first and second auxiliary connectors 55, 54 is opposite to the type of the disconnectable port of the vein and artery connectors. In other words, when the disconnectable port 72 of the first and second auxiliary connectors 55, 54 is convex, the disconnectable port of the artery and vein connector is concave, and vice versa.

[0229] Finally, it is not excluded that the first auxiliary connector and the second auxiliary connector may be placed on any of the aforementioned infusion lines and on the blood circuit, appropriately allowing blood recirculation when connected to the arterial and venous connectors 40, 41.

[0230] Operating method

[0231] The method of operating a disposable circuit according to this disclosure is described in detail below. In this context, during blood treatment, the patient can be temporarily disconnected from device 1, and therefore can also be disconnected from the disposable circuit.

[0232] In use, a disposable circuit is installed on device 1 before processing begins. To facilitate installation and reduce the risk of errors by a qualified operator during installation, device 1 may include visual instructions on its GUI to assist the operator in proper placement. Control unit 10 provides selection options for machine configuration prior to processing on the user interface screen of device 1. Once the prescription and relevant parameters are entered, the disposable circuit is properly activated; thereafter, the blood circuit is connected to the patient's vascular access and processing begins.

[0233] In cases where processing must be temporarily interrupted, the user interface has a corresponding screen where the user can select options for re-encoding, such as icons.

[0234] like Figure 20 The document also briefly discloses that when a patient must disconnect from device 1, the user selects a recirculation configuration selection item on the screen of device 1, and then the control unit 10 configures device 1 in a specific configuration, wherein at least blood pump 11 and preferably all pumps (box 1000) of device 1 are stopped first. At least blood pump 11 needs to be stopped to switch or reconfigure device 1 to the aforementioned recirculation configuration, and thus switch or reconfigure the disposable circuit from the processing configuration to the recirculation configuration, and vice versa, since blood pump 11 is primarily involved in forcing fluid to circulate from the arterial connector to the venous connector in both the operating and recirculation configurations.

[0235] Although, to a non-limiting extent, a stop signal may also be sent to the discharge fluid pump 17 and the dialysis pump 17a. If the dialysis fluid continues to circulate in the fluid loop, at least ultrafiltration is stopped or set to a very low minimum value. Of course, one or more infusion pumps may be operated and the infusion fluid balanced by ultrafiltration.

[0236] Subsequently, (box 1001) the patient is disconnected from device 1: according to one of the above embodiments, the user (and / or device) clamps the end of the blood tubing and then disconnects the arterial connector 40 and the venous connector 41 from the access device (e.g., central catheter or access needle), such that the arterial connector and the venous connector 40, 41 both produce a corresponding disconnectable end that is practically free, ready to be connected to the corresponding free end of the auxiliary connector.

[0237] Typically, the user disconnects the first connector, usually the arterial connector 40, first. Then, depending on the selected recirculation configuration, the disconnected (e.g., arterial) connector is connected to either the first or second auxiliary connector. Afterward, the second connector (e.g., the venous connector 41) is disconnected and subsequently connected to a free connector in either the first or second auxiliary connector that defines the recirculation configuration. In other words, the user disconnects and connects the arterial and venous connectors sequentially.

[0238] like Figure 20 As shown in box 1002, preferably according to the disclosure of any configuration of the foregoing embodiments, the first auxiliary connector and the second auxiliary connector are subsequently connected to the vein connector 41 and the artery connector 40. If the first and second auxiliary connectors are self-sealing, it is generally not necessary for the operator to remove the closure cap from the detachable ports 70, 70a of the auxiliary connectors; otherwise, the operator will appropriately remove any protective and / or closure cap from the detachable ports before properly establishing the connection of the auxiliary connectors with the corresponding artery connector 40 and vein connector 41. Of course, in the case of self-sealing connectors without caps, it may be necessary to clean / sterilize the self-sealing ports before connecting them.

[0239] It should be noted that the flexibility of the disposable circuit catheter disclosed herein allows for easy reconfiguration; it should also be noted that the circuit remains in its original position on device 1 during switching or reconfiguration from the operating configuration to the recirculation configuration. In many cases, the portion of the blood circuit 6, 7 closer to both the arterial connector 40 and the venous connector 41 can be a more accessible and / or free or, in any case, distant portion of the path at least temporarily confined on device 1: therefore, the step of interconnecting the auxiliary connector with the venous connector 40 or the arterial connector 41 can preferably be performed by moving a portion of the blood circuit 6, 7 such that the venous connector (or arterial connector) is physically closer first, and subsequently contacts the free end port of the corresponding auxiliary connector. This facilitates operation for the user and further reduces the time required for reconfiguration of the circuit and device. Due to this aspect, reconfiguration of the recirculation configuration can be performed quickly.

[0240] Once the proper connections are established between the first auxiliary connector, the second auxiliary connector, and the arterial connector 40 and venous connector 41, the blood tubing is released, and the operator will quickly intervene in the user interface of device 1 to set a command to restart at least the blood pump 11. This step is in Figure 20 The diagram is schematically shown in box 1003. Preferably, this is done by interacting with a specific icon on the screen of device 1 or by activating a specific start button on device 1. Figure 20 (Box 1003).

[0241] During the recirculation of fluid in the recirculation configuration, it is undesirable to discharge fluid contained in any fluid lines connected to blood circuits 6 and 7. Therefore, according to the recirculation process, any pumps in the fluid lines connected to blood circuits 6 and 7 are deactivated throughout the recirculation process. This is particularly suitable when both the first and second auxiliary connectors are arranged downstream of the pumps in the fluid lines, as the pump's cessation acts as a means of preventing free fluid circulation in the corresponding fluid lines upstream of the pump. This advantage is further enhanced when the pump used for the fluid lines is a shut-off pump, such as a peristaltic pump, since the latter type of pump not only provides additional resistance to fluid flow when not in operation but also essentially completely shuts off the conductive portion of the fluid line, physically preventing any discharge of fluid from its upstream portion. Thus, contamination of the fluid upstream of the pumps in any lines containing introduced fluid in blood circuits 6 and 7 is prevented or, in any case, significantly reduced.

[0242] In the first alternative, the discharge fluid pump 17 and the dialysis pump 17a stop when the fluid is recirculated in the single-use loop in the recirculation configuration; in another and a second alternative, the discharge fluid pump 17 and the dialysis pump 17a remain active (but without achieving ultrafiltration) when the fluid is recirculated in the single-use loop in the recirculation configuration.

[0243] When the patient's temporary disconnection ends, i.e., when the patient should be reconnected to device 1 via venous connector 40 and auxiliary connector 41 to complete the temporarily suspended blood treatment, the user selects a specific command on a user interface operatively connected to control unit 10. This command stops the activation of blood pump 11 and, if the drain fluid pump 17 and dialysis pump 17a remain active during fluid recirculation, also stops those pumps. The operator then clamps and disconnects venous connector 40 and arterial connector 41 from their respective first and second auxiliary connectors. The closure of the circuit defined when the recirculation configuration of the disposable circuit begins is then terminated, and the disposable circuit is temporarily opened. If the first and second auxiliary connectors are not self-sealing, the operator provides closure of their free, detachable ends; otherwise, if the first and second auxiliary connectors are self-sealing, this subsequent operator action is not required.

[0244] The venous connector 40 and arterial connector 41 are then reconnected to the patient's access device and released; via the menu on the control unit 10 on the screen, the user selects the option corresponding to restarting blood processing, and then restarts the pumps of the device 1, particularly at least the blood pump 11. Preferably, the drain fluid pump 17 and dialysis pump 17a, as well as all infusion pumps (as required to set the processing mode), are also restarted to allow processing delivery.

[0245] Note that the disconnection procedure described above does not require blood to be returned to the patient before the temporary disconnection (although this is possible). Therefore, the recirculation that occurs in the blood tubing and ultimately in the portion of the infusion tubing involved takes place within the patient's blood.

[0246] As an alternative procedure, extracorporeal blood can be restored to the patient before recirculation. According to this embodiment, after the blood pump stops and the blood extraction tubing 6 is clamped, the arterial connector 40 is disconnected from the patient's access device and connected to a bag containing physiological fluid (e.g., saline or alternative fluid). The blood extraction tubing is released and the blood pump is restarted to return blood to the patient via a blood return tubing still connected to the vascular access. Once blood is restored, the blood extraction tubing is clamped and the arterial connector is properly connected to the first or second auxiliary connector. Subsequently, the blood return tubing is clamped, and the venous connector 41 is removed from the access device and connected to the other of the first and second auxiliary connectors. The user releases the blood tubing and begins recirculation of physiological fluid within the recirculation loop.

[0247] It is worth noting that, in the presence of an infusion line in the circuit, the contents of the bag supplied to the infusion line can be used to provide the appropriate fluid for restoring blood. That is, the blood extraction line is clamped and the infusion pump (and blood pump if necessary) is activated to force fluid into the blood line and push the blood into the patient via the blood return line and vascular access. This alternative procedure can even be performed before disconnecting the arterial connector.

[0248] During fluid recirculation, normal alarms such as access, arterial, and venous pressure alarms are deactivated or their alarm windows are changed. In fact, different conditions during recirculation are incompatible with normal alarm thresholds, and failing to change / deactivate them will generate several false alarms.

[0249] The process described herein may be provided by a data processing unit, which is technically interchangeable with one or more data processing units designed to execute a portion of a software program or firmware program loaded into memory. The software or firmware program can be written in any known programming language. If two or more electronic computers are connected to each other via a data link, their computing power can be shared; thus, the electronic computers can be installed in different locations, thereby enabling data connectivity 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 portions of the process defined in this disclosure via software or firmware, or it may be an ASIC, a special-purpose processor, or an FPGA specifically programmed to perform at least a portion of the operation of the process described herein. Memory support may be located internally or externally to the processor or control unit or data processing unit and may be geographically remote from them.

[0250] The present invention is not limited to the embodiments shown in the accompanying drawings. Therefore, it should be understood that when a feature mentioned in the appended claims is followed by a reference numeral, such reference numerals are included merely for the purpose of enhancing the comprehensibility of the claims and in no way limit the scope of the claims.

[0251] Finally, it is apparent that any adaptations or additions may be made to any part of the elements forming part of this disclosure without departing from the scope of protection provided by the appended claims.

Claims

1. A disposable circuit for extracorporeal blood processing, comprising: - Filtering unit (2); - A blood circuit (6, 7) comprising a blood extraction line (6) having a first end connected to an inlet of the filter unit (2) and a blood return line (7) having a first end connected to an outlet of the filter unit (2), the blood extraction line (6) and the blood return line (7) being designed to connect to the patient's cardiovascular system. The blood extraction line (6) has a second end with an arterial connector (40), and the blood return line (7) has a second end with a venous connector (41). The arterial connector (40) and the venous connector (41) are designed to be detachably connected to the patient's vascular access device. The blood circuit is configured to interface with a blood pump (11) for controlling the flow in the blood circuit (6, 7). - At least one fluid conduit (15, 21, 25, 42; 42a) is connected to the blood circuit (6, 7). - A first auxiliary connector (51, 53, 55, 57, 59) disposed on the blood circuit (6, 7) or disposed on the at least one fluid line (15, 21, 25, 42; 42a), the first auxiliary connector (51, 53, 55, 57, 59) being configured to be removably connected to a connector between the arterial connector (40) and the venous connector (41) in a recirculation configuration in order to define a closed loop that allows fluid recirculation in the blood circuit; - A second auxiliary connector (50, 52, 54, 56, 58) is disposed on the blood circuit or on at least one fluid line (15, 21, 25, 42; 42a), wherein the first auxiliary connector (51, 53, 55, 57, 59) and the second auxiliary connector (50, 52, 54, 56, 58) are configured such that one is removably connected to the arterial connector (40) and the other is removably connected to the venous connector (41) to define the closed circuit. The one-time loop can be reversibly configured between a processing configuration and a recirculation configuration; In the processing configuration, the arterial connector (40) and the venous connector (41) are removably connected to the patient’s vascular access device and blood is drawn from the patient through the blood extraction line (6), the blood is circulated through the filter unit (2) and returned to the patient through the blood return line (7); In the recirculation configuration, one of the arterial connector (40) and the venous connector (41) is removably connected to one of the first auxiliary connectors (51, 53, 55, 57, 59) and the second auxiliary connector (50, 52, 54, 56, 58), and 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), wherein, in the recirculation configuration, the fluid contained in the blood circuit (6, 7) is recirculated within the disposable circuit.

2. A disposable circuit for extracorporeal blood processing, comprising: - Filtering unit (2); - A blood circuit (6, 7) comprising a blood extraction line (6) having a first end connected to an inlet of the filter unit (2) and a blood return line (7) having a first end connected to an outlet of the filter unit (2), the blood extraction line (6) and the blood return line (7) being designed to connect to the patient's cardiovascular system. The blood extraction line (6) has a second end with an arterial connector (40), and the blood return line (7) has a second end with a venous connector (41). The arterial connector (40) and the venous connector (41) are designed to be detachably connected to the patient's vascular access device. The blood circuit is configured to interface with a blood pump (11) for controlling the flow in the blood circuit (6, 7). - A first auxiliary connector (51, 53, 55, 57, 59) is disposed on the blood circuit (6, 7) and is configured to be removably connected to a connector between the arterial connector (40) and the venous connector (41) in a recirculation configuration in order to define a closed loop that allows fluid recirculation in the blood circuit; - A second auxiliary connector (50, 52, 54, 56, 58) is disposed on the blood circuit, wherein the first auxiliary connector (51, 53, 55, 57, 59) and the second auxiliary connector (50, 52, 54, 56, 58) are configured such that one is removably connected to the arterial connector (40) and the other is removably connected to the venous connector (41) to define the closed circuit. The one-time loop can be reversibly configured between a processing configuration and a recirculation configuration; In the processing configuration, the arterial connector (40) and the venous connector (41) are removably connected to the patient’s vascular access device and blood is drawn from the patient through the blood extraction line (6), the blood is circulated through the filter unit (2) and returned to the patient through the blood return line (7); In the recirculation configuration, one of the arterial connector (40) and the venous connector (41) is removably connected to one of the first auxiliary connectors (51, 53, 55, 57, 59) and the second auxiliary connector (50, 52, 54, 56, 58), and 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), wherein, in the recirculation configuration, the fluid contained in the blood circuit (6, 7) is recirculated within the disposable circuit.

3. The one-time circuit according to claim 1, wherein, At least one fluid line (15, 21, 25, 42; 42a) connected to the blood circuit includes at least one auxiliary line (42, 42a), the first auxiliary connector and the second auxiliary connector being mounted on the same single auxiliary line (42), the auxiliary line (42) having its own dedicated fluid pump conduit on which the fluid pump operates, and one of the first auxiliary connector and the second auxiliary connector being mounted upstream of the other auxiliary connector.

4. The one-time circuit according to claim 1 or 2, wherein, The first auxiliary connector (51, 53, 55, 57, 59) and the second auxiliary connector (50, 52, 54, 56, 58) are both three-port connectors, each having a detachable port (70) configured to connect to one of the vein connector (41) and the artery connector (40). The first auxiliary connector (51, 53, 55, 57, 59) and the second auxiliary connector (50, 52, 54, 56, 58) are both provided with: - A first non-disconnectable maintenance port (71) and a second non-disconnectable maintenance port (71), which are fixed to the corresponding pipe sections; - The disconnectable port (70).

5. The one-time circuit according to claim 1, wherein, The at least one fluid conduit (15, 21, 25; 42; 42a) includes one or more of the following conduits: - Post-blood pump pre-dilution infusion line (15), which is directly connected to the blood extraction line (6). - A pre-blood pump pre-dilution infusion line (21) is directly connected to the blood extraction line (6). - Post-dilution fluid line (25), which is directly connected to the blood return line (7). The first auxiliary connector (51, 53, 55, 57, 59) is provided with a first non-disconnectable maintenance port (71) and a second non-disconnectable maintenance port (71). The first non-disconnectable maintenance port (71) and the second non-disconnectable maintenance port (71) are fixed to the corresponding pipe portion of the fluid pipeline (15, 21, 25, 42; 42a), and the first auxiliary connector is arranged at the corresponding pipe portion.

6. The one-time circuit according to claim 1, wherein, The second auxiliary connector (50, 52, 54, 56, 58) is provided with a first non-disconnectable maintenance port (71) and a second non-disconnectable maintenance port (71), which are fixed to the corresponding pipe portions of the fluid lines (15, 21, 25, 42; 42a), and the second auxiliary connector is arranged at the corresponding pipe portions.

7. In the disposable circuit according to claim 6, 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. The disposable circuit according to claim 1, comprising a pre-blood pump pre-dilution infusion line (21) directly connected to the blood extraction line (6), wherein, A first auxiliary connector (53) and a second auxiliary connector (52) are fixed to the pre-blood pump pre-dilution infusion line (21), wherein, in the recirculation configuration, the first auxiliary connector (53) disposed on the pre-blood pump pre-dilution infusion line (21) is connected to the arterial connector (40), and the second auxiliary connector (52) disposed on the pre-blood pump pre-dilution infusion line (21) is connected to the venous connector (41).

9. The one-time circuit according to 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. The disposable circuit of claim 1, comprising a pre-blood pump pre-dilution infusion line (21) configured to allow fluid to be dispensed to a blood circuit downstream of the arterial connector (40); the pre-blood pump pre-dilution infusion line (21) comprising a peristaltic pump line configured to connect to a corresponding peristaltic pump and a container, the pre-blood pump pre-dilution infusion line (21) being connected to the container, and a first auxiliary connector (53) and a second auxiliary connector (52) being connected to the pre-blood pump pre-dilution infusion line (21) downstream of the peristaltic pump line.

11. The disposable circuit according to claim 1 or 2, comprising a first pressure-drop valve or flow resistor (60) configured to uniformly distribute fluid flow during recirculation, the first pressure-drop valve or flow resistor (60) being disposed on the blood circuit or on at least one fluid line (15, 21, 25, 42; 42a), the first pressure-drop valve or flow resistor (60) being configured to uniformly distribute fluid flow resistance between corresponding fluid flow resistances of two connected branch sections during recirculation, wherein, The first pressure drop valve or flow resistor (60) is arranged in one of two branch pipe sections, the two branch pipe sections including a portion of the fluid line (15, 21, 25, 42, 42a) and a portion of the blood circuit (6, 7).

12. The one-time circuit according to claim 1 or 2, further comprising: - A discharge fluid line (13) is connected to the outlet of the secondary chamber (4), and - Dialysis fluid tubing (19), which is connected to the inlet of the secondary chamber (4), The one-time circuit is a CRRT one-time circuit.

13. The one-time circuit according to claim 1 or 2, wherein, A first auxiliary connector (51, 53, 55, 57, 59) and a second auxiliary connector (50, 52, 54, 56, 58) are arranged on the blood circuit (6, 7), wherein, 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 extraction line (6) is connected to the venous connector (41).

14. The one-time circuit according to claim 1 or 2, wherein, Both the first auxiliary connector (51, 53, 55, 57, 59) and the second auxiliary connector (50, 52, 54, 56, 58) are provided with a disconnectable port (70; 70a), which is configured to connect to a corresponding disconnectable port (72) of the vein connector (41) or the artery connector (40).

15. The one-time circuit according to claim 14, wherein, The first auxiliary connector (51, 53, 55, 57, 59) and the second auxiliary connector (50, 52, 54, 56, 58) are both three-port connectors, each having a detachable port (70) configured to connect to a detachable port (72) of either the vein connector (41) or the artery connector (40).

16. The one-time circuit according to claim 15, wherein: - The disconnectable port (70; 70a) of the first auxiliary connector (51, 53, 55, 57, 59) and the disconnectable port (72) of the arterial connector (40) or the venous connector (41) are a first convex shape or a second concave shape, wherein the first convex shape is configured to be at least partially introduced into the second concave shape; - Both the arterial connector (40) and the venous connector (41) are connectors provided with a first type of detachable port (72), or, - Both the arterial connector (40) and the venous connector (41) are provided with a second type of disconnectable port (72).

17. The one-time circuit according to claim 16, wherein, The first auxiliary connector (51, 53, 55, 57, 59) and the second auxiliary connector (50, 52, 54, 56, 58) have disconnectable ports (70) that are either convex or concave.

18. The one-time circuit according to claim 1, wherein, A first auxiliary connector (51, 53, 55, 57, 59) and a second auxiliary connector (50, 52, 54, 56, 58) are on at least one fluid line, with one auxiliary connector installed upstream of the other, the at least one fluid line having its own dedicated fluid pump line on which the fluid pump operates, and the first auxiliary connector (51, 53, 55, 57, 59) and the second auxiliary connector (50, 52, 54, 56, 58) being placed downstream of the fluid pump line.

19. The disposable circuit according to claim 1 or 2, wherein the disposable circuit is a CRRT disposable circuit for use in a renal failure device for extracorporeal blood processing in the acute field, the CRRT disposable circuit comprising a disposable dialysis fluid line (19) non-removably connected to the inlet of the secondary chamber (4) and a disposable discharge line (13) non-removably connected to the outlet of the secondary chamber (4).

20. The one-time circuit according to claim 1 or 2, wherein, In the 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 connectors (50, 52, 54, 56, 58), and from the second auxiliary connectors (50, 52, 54, 56, 58) to the first auxiliary connectors (51, 53, 55, 57, 59), and from the first auxiliary connectors (51, 53, 55, 57, 59) to the arterial connector (40).

21. The one-time circuit according to claim 1 or 2, 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 as a single piece.

22. An apparatus for extracorporeal blood processing, comprising a disposable circuit according to claim 1 or 2, the apparatus further comprising a control unit (10) configured to control blood flow in the blood circuit (6, 7) and a blood pump (11). in, The control unit (10) is configured to: - Stop the blood pump (11); - Receive a command to initiate fluid recirculation in the blood circuit (6, 7); - When the disposable circuit is in recirculation configuration, the blood pump (11) is activated to recirculate the fluid inside the blood circuit (6, 7).

23. The apparatus according to claim 22, wherein, In the recirculation configuration, the first auxiliary connector (51, 53, 55, 57, 59) is directly connected to the arterial connector (40) or the venous connector (41), and the second auxiliary connector (50, 52, 54, 56, 58) is directly connected to another of the arterial connector (40) and the venous connector (41). The control unit (10) is configured to maintain the disposable circuit in the recirculation configuration, wherein, during recirculation, the full flow rate of fluid 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 the two partial flow rates of fluid entering the first auxiliary connector (51, 53, 55, 57, 59) or the second auxiliary connector (50, 52, 54, 56, 58) are combined and flow out as the full flow rate.

24. The apparatus according to claim 22, wherein, In the processing configuration, the control unit (10) is configured as follows: - Receive or calculate an initial value for one or more fluid flow rates selected from the group consisting of: the fluid flow rate (Q) through the discharge line (13). eff The fluid flow rate (Q) through at least one fluid delivery line (15, 21, 25, 42; 42a) pre Q pbp Q post ), the fluid flow rate (Q) through the dialysis fluid line (19) dial ), fluid removal rate from the patient (Q pfr ), and blood flow velocity (Q) b );as well as - Actuate one or more of the blood pump (11), infusion pump (18; 22; 27), dialysis pump (17a), and draining fluid pump (17) to deliver a specified or calculated flow rate.

25. The apparatus according to claim 22, wherein, In order to initiate the recirculation configuration, the control unit (10) is configured to: - Receive a command to initiate temporary fluid recirculation in the blood circuits (6, 7); - Set the value of the recirculation flow rate through the blood circuit (6, 7); - When in the recirculation configuration, the blood pump (11) is activated to recirculate fluid in the blood circuit (6, 7); The recirculation configuration occurs after the processing configuration is interrupted, and the flow rate of fluid in the blood circuit (6, 7) is temporarily reduced to zero by disabling the blood pump (11) and one or more infusion pumps (18, 22, 27).

26. The apparatus according to claim 25, wherein, The control unit (10) is configured to obtain electronic confirmation that the arterial connector (40) is disconnected from the venous connector (41) before allowing the blood pump (11) to be started for recirculation.

27. The apparatus according to claim 22, wherein, In the processing configuration, the first auxiliary connector (51, 53, 55, 57, 59) and the second auxiliary connector (50, 52, 54, 56, 58) are not connected to either the arterial connector (40) or the venous connector (41), and in the recirculation configuration, the first auxiliary connector (51, 53, 55, 57, 59) is directly connected to one of the connectors between the arterial connector (40) and the venous connector (41), and the second auxiliary connector (50, 52, 54, 56, 58) is directly connected to the other connector between the arterial connector (40) and the venous connector (41).

28. A method for temporarily disconnecting a patient from a device for extracorporeal blood processing, said device comprising a disposable circuit according to claim 1 or 2, the method comprising: - Stop the blood pump that has started on the blood circuit; - Disconnect the arterial connector (40) from the patient's access device; - Disconnect the vein connector (41) from the patient's access device; - Connect one of the arterial connector (40) and the venous connector (41) to the first auxiliary connector (51, 53, 55, 57, 59) to define the recirculation configuration; - Connect the other of the arterial connector (40) and the venous connector (41) to the second auxiliary connector (50, 52, 54, 56, 58) to define a closed loop in the disposable circuit to define the recirculation configuration; - While the patient remains disconnected from the device, the blood pump is operated to begin recirculating the fluid within the closed loop.

29. The method of claim 28, further comprising: - Stop the blood pump to stop the recirculation of fluid within the closed loop; - Disconnect one of the arterial connector (40) and the venous connector (41) from the first auxiliary connector (51, 53, 55, 57, 59); - Disconnect the other connector of the arterial connector (40) and the venous connector (41) from the second auxiliary connector (50, 52, 54, 56, 58); - Before resuming the treatment, reconnect the arterial connector (40) and the venous connector (41) to the patient's access device; The method steps are performed without altering the one-time circuit or disconnecting the one-time circuit from the device.

Images