Disposable sets, devices and procedures for blood recirculation in extracorporeal blood treatment devices

Abstract

The disposable set and extracorporeal blood treatment device include a blood circuit including a filtration unit, a blood removal line, a blood return line, and a blood pump path on the blood removal line or on the blood return line, and are configured to be engaged with a blood pump of the extracorporeal blood treatment device to promote blood flow within the blood circuit. The blood circuit further includes an infusion section connected to both the blood removal line at a first site and the blood return line at a second site. The blood circuit can be configured as a loop recirculation circuit including the filtration unit, the blood pump path, a portion of the blood removal line, a portion of the blood return line, and a recirculation section of the infusion line disposed between the first site and the second site.

Description

[Technical Field]

[0001] The present invention relates to a disposable set for an extracorporeal blood treatment device configured to allow recirculation of fluid / blood within the loop in the event that treatment needs to be interrupted (e.g., temporarily) when, for example, an alarm is activated that stops the blood pump.

[0002] The invention also relates to a device for extracorporeal blood treatment and a procedure for performing fluid / blood recirculation in a loop in a disposable set of an extracorporeal blood treatment device.

[0003] The extracorporeal blood treatment device of the present invention can perform dialysis therapies such as hemodialysis (HD), hemofiltration (HF), hemodiafiltration (HDF), or ultrafiltration (UF), as well as continuous renal replacement therapy (CRRT), and the device can also be configured for ECC02R or oxygenation therapy, as well as adsorption, hemoperfusion, liver therapy, or plasma exchange. [Background technology]

[0004] The kidneys perform many functions, including the removal of water, the excretion of catabolites (or waste products from metabolism, e.g., urea and creatinine), the regulation of electrolyte concentrations in the blood (e.g., sodium, potassium, magnesium, calcium, bicarbonate, phosphate, chloride), and the regulation of the body's acid / base balance, particularly through the removal of weak acids and the production of ammonium salts. In individuals who have lost the use of their kidneys (either temporarily or permanently), these excretory and regulatory mechanisms no longer function, so the body accumulates water and waste products from metabolism, exhibits excess electrolytes, and generally exhibits acidosis (a downward shift in plasma pH below 7.35 (blood pH normally fluctuates within narrow limits between 7.35 and 7.45)). As mentioned above, to overcome renal dysfunction, conventional blood therapy involves extracorporeal circulation through an exchanger with a semipermeable membrane (dialyzer), in which the patient's blood is circulated on one side of the membrane and a dialysate containing major blood electrolytes at concentrations similar to those in healthy subjects' blood is circulated on the other side. Furthermore, a pressure difference is created between the two compartments of the dialyzer defined by the semipermeable membrane, resulting in a portion of the plasma fluid passing through the membrane into the compartment containing the dialysate by ultrafiltration. Blood therapy performed in a dialyzer for metabolic waste products and electrolytes results from two mechanisms of molecular transport across the membrane. In one, molecules move from a fluid with a higher concentration to a fluid with a lower concentration. This is diffusion transport. In the other, certain catabolites and certain electrolytes are taken up by the plasma fluid filtering through the membrane under the influence of the pressure difference created between the two compartments of the exchanger. This is convective transport. Thus, three of the above-mentioned functions of the kidneys, namely, water removal, excretion of catabolites, and regulation of blood electrolyte concentrations, are performed in conventional blood treatment machines by a combination of dialysis and hemofiltration (this combination is called hemodiafiltration).To perform one or more of the above-mentioned therapies, the extracorporeal blood treatment machine may include a disposable set containing multiple lines for delivering fluids directly to the patient or into the extracorporeal blood circuit.

[0005] Disposable sets for extracorporeal blood treatment generally include a fluid circuit including fluid lines, blood lines, and a filtration unit. The disposable set is typically mated to the front panel of an extracorporeal blood treatment device for delivering any one of the above-mentioned therapies.

[0006] EP 1 590 017 A1 discloses an extracorporeal blood treatment machine having a blood circuit including an inlet line to a filtration unit and an outlet line from the filtration unit. The fluid circuit includes an inlet line to the filtration unit and an outlet line from the filtration unit, allowing fluid drawn from a primary container to circulate within the filtration unit. An infusion line supplied by an auxiliary fluid container is provided for infusing the outlet line of the blood circuit. The infusion line has an infusion branch that injects fluid into the inlet line of the blood circuit, allowing the intensive care machine to administer treatments with large fluid exchanges both pre-infusion and post-infusion.

[0007] In the case of extracorporeal blood circulation, one relevant concern involves reducing the risk of blood clotting within the blood lines of the disposable set.

[0008] However, during extracorporeal blood therapy, it may be necessary to stop the blood pump (i.e., stop the extracorporeal blood circulation) when extracorporeal blood is still in the blood circuit of the device, for example, when an alarm is issued that requires the treatment to be temporarily interrupted to allow the operator to resolve the problem. In such a situation, the blood remains stationary in the blood line, increasing the risk of blood clotting both in the blood line and in the filtration unit. The risk of blood clotting increases over time, and therefore the operator needs to be able to resume treatment as quickly as possible. In such an alarm situation where the blood pump is stopped, a stressful situation arises for the operator, especially an inexperienced operator.

[0009] If a clot forms in the line and / or in the filtration unit, the disposable set must be discarded and replaced with a new one, which results in substantial blood loss from the patient and increases the cost and time of treatment.

[0010] U.S. Patent Application Publication No. 20150292529 discloses a system for treating blood, including a single cassette capable of performing various CRRT therapies. The circuit includes a pre-dilution line and a post-dilution line for supplying the replacement fluid required for the therapy. The cassette has one chamber on the blood withdrawal line corresponding to the pre-infusion line and another chamber on the blood return line corresponding to the post-infusion line. A channel connects the two chambers. In the event of a problem, a pump in the blood circuit continues to operate to circulate blood in a loop between the first and second chambers and the filter, collecting blood from the second chamber. Summary of the Invention

[0011] SUMMARY OF THE INVENTION It is therefore an object of the present invention to at least partially overcome one or more of the above-mentioned drawbacks and / or limitations.

[0012] The first objective is to reduce the risk of clotting in the extracorporeal blood circuit by preventing blood stagnation.

[0013] A further objective is to more easily address alarms that cause the blood pump to stop, thus inducing a risk of circuit clotting if troubleshooting is delayed, and to prevent or at least reduce the risk of blood clotting in the lines of the disposable set.

[0014] A further objective is to give the practitioner more time (and therefore less stress) during temporary interruptions in treatment to resolve treatment or patient issues and / or troubleshoot, such as resetting device parameters.

[0015] An additional objective is to improve the lifespan of disposable sets, especially those associated with CRRT treatment.

[0016] A further objective is to avoid blood volumes contained within the discarded disposable set resulting in patient blood loss and circuit waste, thus also reducing waste during extracorporeal blood therapy.

[0017] A secondary objective is to allow the greatest possible recirculation in the blood removal line in order to avoid blood stagnation in long sections of the blood line.

[0018] These objects and many more that will become more apparent from the following description are substantially achieved by disposable sets, devices, and recycling procedures according to one or more of the following claims and / or aspects. Not all objects are achieved by each and every embodiment of the invention.

[0019] The disposable set according to the invention is based on the combination of features of claim 1. The device according to the invention is based on the combination of features of claim 13.

[0020] The first aspect is one or more pumps (21, 25, 26, 54, 65, 75) including a blood pump (21); - one or more intercept elements (20, 27, 59, 70), A disposable set (100), a filtration unit (2) having a blood inlet (2a) and a blood outlet (2b); A blood circuit (17), a blood removal line (6) extending between a first end (6a) connected to the blood inlet (2a) of the filtration unit (2) and a second end (6b) for connection to a patient (P); a blood return line (7) extending between a first end (7a) connected to the blood outlet (2b) of the filtration unit (2) and a second end (7b) for connection to a patient; a blood circuit (17) including a blood pump path (6p) located on the blood circuit (17) and engaging with a blood pump (21) of an extracorporeal blood treatment device to promote blood flow within the blood circuit; an infusion line (63) extending from a first end (63a) for connection to an infusion fluid source (64), at a branching site (67); ■ a second end (63b) of the injection line (63) that is in direct or indirect fluid communication with the blood removal line (6) at the first site (31), the first site (31) being disposed between the second end (6b) of the blood removal line (6) and the blood pump path (6p); and a third end (63c) of the infusion line (63) that is in direct or indirect fluid communication with the blood return line (7) at the second site (32), the second site (32) being disposed between the blood pump path (6p) and the second end of the blood return line (7); an injection line (63) branching off towards a disposable set (100) including a control unit (12) configured to control one or more pumps (21, 25, 26, 54, 65, 75) and one or more intercept elements (20, 27, 59, 70) to define different flow circuits within the blood circuit (17) and the infusion line (63), the control unit (12) comprising at least a therapeutic flow circuit, in which one or more pumps (21, 25, 26, 54, 65, 75) and one or more intercepting elements (20, 27, 59, 70) are configured to allow blood to flow from the second end (6b) of the blood removal line (6) to the filtration unit (2) and from the filtration unit (2) to the second end (7b) of the blood return line (7); a control unit (12) configured to define a flow circuit of: a loop recirculation circuit (11) in which one or more pumps (21, 25, 26, 54, 65, 75) and one or more intercepting elements (20, 27, 59, 70) are configured to allow blood or liquid to flow continuously in a loop circulation; An extracorporeal blood treatment device comprising: The loop recirculation circuit (11) - Filtration unit (2), ●Blood pump pathway (6p) and a part of the blood removal line (6) disposed between the first site (31) of the blood removal line (6) and the blood inlet (2a) of the filtration unit (2); a portion of the blood return line (7) disposed between the blood outlet (2b) of the filtration unit (2) and the second site (32) of the blood return line (7); A recirculation portion (66) of the injection line (63) located downstream of the branching site (67) and between the first site (31) and the second site (32).

[0021] In a second independent aspect, a disposable set (100) for an extracorporeal blood treatment device (1) is provided, a filtration unit (2) having a blood inlet (2a) and a blood outlet (2b); a blood circuit (17), a blood removal line (6) extending between a first end (6a) connected to the blood inlet (2a) of the filtration unit (2) and a second end (6b) for connection to a patient (P); a blood return line (7) extending between a first end (7a) connected to the blood outlet (2b) of the filtration unit (2) and a second end (7b) for connection to a patient; a blood circuit (17) including a blood pump path (6p) located on the blood circuit (17) and configured to engage a blood pump (21) of an extracorporeal blood treatment device to promote blood flow within the blood circuit; an infusion line (63) extending from a first end (63a) for connection to an infusion fluid source (64), at a branching site (67); a second end (63b) of the infusion line (63) that is in direct or indirect fluid communication with the blood removal line (6) at the first site (31), the first site (31) being disposed between the second end (6b) of the blood removal line (6) and the blood pump path (6p); and a third end (63c) of the infusion line (63) in direct or indirect fluid communication with the blood return line (7) at the second site (32), the second site (32) being disposed between the blood pump path (6p) and the second end of the blood return line (7); an injection line (63) branching off towards Including, The blood circuit is a filtration unit (2), -blood pump pathway (6p) and a portion of the blood removal line (6) disposed between the first site (31) of the blood removal line (6) and the blood inlet (2a) of the filtration unit (2); a portion of the blood return line (7) arranged between the blood outlet (2b) of the filtration unit (2) and the second site (32) of the blood return line (7); - a recirculation section (66) of the injection line (63) located downstream of the branching site (67) and between the first site (31) and the second site (32), The loop recirculation circuit (11) is configured to allow at least the blood or fluid in the recirculation state to flow continuously within the loop circulation.

[0022] In a third independent aspect, a method for recirculating blood in an extracorporeal blood treatment device (1) is provided, the device (1) comprising: one or more pumps (21, 25, 26, 54, 65, 75) including a blood pump (21); - one or more intercept elements (20, 27, 59, 70), A disposable set (100) in particular according to any one of the preceding claims, a filtration unit (2) having a blood inlet (2a) and a blood outlet (2b); A blood circuit (17), a blood removal line (6) extending between a first end (6a) connected to the blood inlet (2a) of the filtration unit (2) and a second end (6b) for connection to a patient (P); a blood return line (7) extending between a first end (7a) connected to the blood outlet (2b) of the filtration unit (2) and a second end (7b) for connection to a patient; a blood circuit (17) including a blood pump path (6p) located on the blood circuit (17) and engaging with a blood pump (21) of an extracorporeal blood treatment device to promote blood flow within the blood circuit; an infusion line (63) extending from a first end (63a) for connection to an infusion fluid source (64), at a branching site (67); (ii) a second end (63b) of the injection line (63) that is in direct or indirect fluid communication with the blood removal line (6) at the first site (31), the first site (31) being disposed between the second end (6b) of the blood removal line (6) and the blood pump path (6p); and a third end (63c) of the infusion line (63) that is in direct or indirect fluid communication with the blood return line (7) at the second site (32), the second site (32) being disposed between the blood pump path (6p) and the second end of the blood return line (7); an injection line (63) branching off towards a disposable set (100) including a control unit (12) configured to control one or more pumps (21, 25, 26, 54, 65, 75) and one or more interceptor elements (20, 27, 59, 70) to define different flow circuits within the blood circuit (17) and the infusion line (63); Including, The method of recirculating blood is from a therapeutic flow circuit in which one or more pumps (21, 25, 26, 54, 65, 75) and one or more intercepting elements (20, 27, 59, 70) allow blood to flow from the second end (6b) of the blood removal line (6) to the filtration unit (2) and from the filtration unit (2) to the second end (7b) of the blood return line (7); >One or more pumps (21, 25, 26, 54, 65, 75) and one or more intercepting elements (20, 27, 59, 70) in a loop recirculation circuit (11) that allows blood or fluid to flow continuously in a loop circulation; Including switching The loop recirculation circuit (11) - Filtration unit (2), ●Blood pump pathway (6p) and a part of the blood removal line (6) disposed between the first site (31) of the blood removal line (6) and the blood inlet (2a) of the filtration unit (2); a portion of the blood return line (7) disposed between the blood outlet (2b) of the filtration unit (2) and the second site (32) of the blood return line (7); a recirculation portion (66) of the injection line (63) located downstream of the branching site (67) and between the first site (31) and the second site (32).

[0023] In a fourth independent aspect, an extracorporeal blood treatment device comprises: one or more pumps (21, 25, 26, 54, 65, 75) including a blood pump (21); - one or more intercept elements (20, 27, 59, 70), A disposable set (100), a filtration unit (2) having a blood inlet (2a) and a blood outlet (2b); A blood circuit (17), a blood removal line (6) extending between a first end (6a) connected to the blood inlet (2a) of the filtration unit (2) and a second end (6b) for connection to a patient (P); a blood return line (7) extending between a first end (7a) connected to the blood outlet (2b) of the filtration unit (2) and a second end (7b) for connection to a patient; a blood circuit (17) including a blood pump path (6p) located on the blood circuit (17) and engaging with a blood pump (21) of an extracorporeal blood treatment device to promote blood flow within the blood circuit; a first end (51a) for connection to a second fluid source (10), and a pre-blood pump infusion line (51) extending from the second end (51b) fluidly connected to the blood removal line (6) between the second end (6b) of the blood removal line (6) and the blood pump path (6p); an infusion line (63) extending from a first end (63a) for connection to an infusion fluid source (64), at a branching site (67); a second end (63b) of the infusion line (63) that is directly connected to the pre-blood pump infusion line (51) and is in fluid communication with the blood removal line (6) at the first site (31), the first site (31) being located between the second end (6b) of the blood removal line (6) and the blood pump path (6p); and a third end (63c) of the infusion line (63) that is in direct or indirect fluid communication with the blood return line (7) at the second site (32), the second site (32) being disposed between the blood pump path (6p) and the second end of the blood return line (7); an injection line (63) branching off towards a disposable set (100) including a control unit (12) configured to control one or more pumps (21, 25, 26, 54, 65, 75) and one or more intercept elements (20, 27, 59, 70) to define different flow circuits within the blood circuit (17) and the infusion line (63), the control unit (12) comprising at least a therapeutic flow circuit, in which one or more pumps (21, 25, 26, 54, 65, 75) and one or more intercepting elements (20, 27, 59, 70) are configured to allow blood to flow from the second end (6b) of the blood removal line (6) to the filtration unit (2) and from the filtration unit (2) to the second end (7b) of the blood return line (7); a control unit (12) configured to define a flow circuit of: a loop recirculation circuit (11) in which one or more pumps (21, 25, 26, 54, 65, 75) and one or more intercepting elements (20, 27, 59, 70) are configured to allow blood or liquid to flow continuously in a loop circulation; Including, The infusion line (63) and the pre-blood pump infusion line (51) are connected to each other to form a common infusion path extending to the first site (31) of the blood removal line (6), and the loop recirculation circuit (11) is - Filtration unit (2), ●Blood pump pathway (6p) and a part of the blood removal line (6) disposed between the first site (31) of the blood removal line (6) and the blood inlet (2a) of the filtration unit (2); a portion of the blood return line (7) disposed between the blood outlet (2b) of the filtration unit (2) and the second site (32) of the blood return line (7); a recirculation section (66) of the injection line (63) located downstream of the branching site (67) and between the first site (31) and the second site (32); ●Common injection route and Includes.

[0024] In a fifth independent aspect, a disposable set (100) for an extracorporeal blood treatment device (1) is provided, a filtration unit (2) having a blood inlet (2a) and a blood outlet (2b); a blood circuit (17), a blood removal line (6) extending between a first end (6a) connected to the blood inlet (2a) of the filtration unit (2) and a second end (6b) for connection to a patient (P); a blood return line (7) extending between a first end (7a) connected to the blood outlet (2b) of the filtration unit (2) and a second end (7b) for connection to a patient; a blood circuit (17) including a blood pump path (6p) located on the blood circuit (17) and configured to engage a blood pump (21) of an extracorporeal blood treatment device to promote blood flow within the blood circuit; a pre-blood pump infusion line (51) extending from a first end (51a) for connection to a second fluid source (10) and a second end (51b) fluidly connected to the blood removal line (6) between the second end (6b) of the blood removal line (6) and the blood pump path (6p); an infusion line (63) extending from a first end (63a) for connection to an infusion fluid source (64), at a branching site (67); a second end (63b) of the infusion line (63) that is directly connected to the pre-blood pump infusion line (51) and that is in fluid communication with the blood removal line (6) at the first site (31), the first site (31) being located between the second end (6b) of the blood removal line (6) and the blood pump path (6p); and a third end (63c) of the infusion line (63) in direct or indirect fluid communication with the blood return line (7) at the second site (32), the second site (32) being disposed between the blood pump path (6p) and the second end of the blood return line (7); an injection line (63) branching off towards a disposable set (100) including Including, The infusion line (63) and the pre-blood pump infusion line (51) are connected to each other to form a common infusion path extending to the first site (31) of the blood removal line (6), and the blood circuit is a filtration unit (2), -blood pump pathway (6p) and a portion of the blood removal line (6) disposed between the first site (31) of the blood removal line (6) and the blood inlet (2a) of the filtration unit (2); a portion of the blood return line (7) arranged between the blood outlet (2b) of the filtration unit (2) and the second site (32) of the blood return line (7); a recirculation section (66) of the injection line (63) located downstream of the branching site (67) and between the first site (31) and the second site (32); a common injection route; designed to allow liquid flow in a loop recirculation circuit (11) including The loop recirculation circuit (11) is configured to allow at least the blood or fluid in the recirculation state to flow continuously within the loop circulation.

[0025] In the following dependent aspects, features of disposable sets are provided that may be implemented in combination with the devices, disposable sets, and methods of the previous aspects.

[0026] In a sixth aspect according to any one of the previous aspects, the loop recirculation circuit (11) is configured to allow liquid to be recirculated in a first direction from the first site (31) towards the filtration unit (2) and from the filtration unit (2) towards the second site (32), or in a second direction from the second site (32) towards the filtration unit (2) and from the filtration unit (2) towards the first site (31).

[0027] In a seventh aspect according to any one of the preceding aspects, the blood inlet (2a) of the filtration unit (2) is in bidirectional fluid communication with the recirculation portion (66) of the infusion line (63) via the first site (31); The blood outlet (2b) of the filtration unit (2) is in bidirectional fluid communication with the recirculation part (66) of the infusion line (63) via the second site (32).

[0028] In an eighth embodiment according to any one of the previous embodiments, the second end (63b) of the infusion line (63) is directly connected to the blood removal line (6) at the first site (31).

[0029] In a ninth aspect according to any one of the previous aspects, the first site (31) comprises: a blood inlet fluidly connected to the withdrawal line (6) and facing the second end (6b) of the blood withdrawal line (6); a blood outlet fluidly connected to the withdrawal line (6) and facing the first end (6a) of the blood removal line (6) and optionally facing the pump path (6p) of the blood removal line (6); an injection inlet fluidly connected to the recirculation part (66) of the injection line (63), in particular to the second end (63b) of the injection line (63); The present invention relates to a liquid connector, particularly a three-way liquid connector, including:

[0030] In a tenth aspect according to any one of the previous aspects, the disposable set further includes at least one pressure detection site (48a, 49a) arranged on the blood removal line (6) between the first site (31) and the filtration unit (2), and in particular, the at least one pressure detection site (48a, 49a) is a pressure pod.

[0031] In an eleventh aspect according to any one of the previous aspects, the disposable set further includes a pressure detection site (48a) arranged on the blood removal line (6) between the first site (31) and the blood pump path (6p), and in particular, the pressure detection site (48a) is a pressure pod.

[0032] In a twelfth aspect according to any one of the previous aspects, the disposable set further includes a pressure detection site (49a) arranged on the blood removal line (6) between the blood pump path (6p) and the filtration unit (2), and in particular, the pressure detection site (49a) is a pressure pod.

[0033] In a thirteenth aspect according to any one of the previous aspects, the disposable set further includes a pressure detection site (50a) disposed on the infusion line (63) between the branching site (67) and the second end (63b) of the infusion line (63).

[0034] In a fourteenth aspect according to any one of the preceding aspects, the pump path (6p) is arranged on the blood removal line (6), in particular between the first site (31) and the first end (6a) of the blood removal line (6); or The pumping path (6p) is arranged on the blood return line (7), in particular between the first end (7a) of the blood return line (7) and the second site (32).

[0035] In a fifteenth aspect according to any one of the preceding aspects, the first site (31) is arranged on the blood removal line (6) upstream of the blood pump path (6p) with respect to the blood removal direction (200) from the second end (6b) of the blood removal line (6) toward the first end (6a), and in particular, the first site (31) is arranged upstream of a blood pump (21) of an extracorporeal blood treatment device configured to act on the blood removal line (6) blood pump path (6p).

[0036] In a sixteenth aspect according to any one of the previous aspects, the infusion line (63) extends from a first end (63a) of the infusion line (63) to a first path (72), the first path (72) including, at a branching site (67): a second passage (68) extending from the branching site (67) to the second end (63b) of the injection line (63); a third passage (69) extending from the branching site (67) to the third end (63c) of the injection line (63); branch into The recirculation portion (66) of the injection line (63) includes a second path (68) and a third path (69) of the injection line (63).

[0037] In a seventeenth embodiment according to the previous embodiment, the infusion line (63) includes a respective infusion pump pathway (65p) configured to be engaged by an infusion pump (65) of the extracorporeal blood treatment device, the infusion pump pathway (65p) being disposed between a first end (63a) of the infusion line (63) and the branching site (67).

[0038] In an eighteenth embodiment according to the previous embodiment, the infusion pump path (65p) of the infusion line (63) is arranged on the first path (72) of the infusion line (63), and in particular, the infusion pump path (65p) is part of the first path (72) of the infusion line (63).

[0039] In a nineteenth embodiment according to any one of the previous embodiments, the fluid source (64) includes a pre-packaged bag containing substitution fluid.

[0040] In a twentieth embodiment according to any one of the previous embodiments, the third end (63c) of the infusion line (63) is directly connected to the blood return line (7) at the second site (32).

[0041] In a 21st aspect according to any one of the previous aspects, the disposable set includes a bubble trap (19) disposed on the return line (7) of the blood circuit (17), the bubble trap (19) being configured to remove air bubbles from the blood during extracorporeal blood therapy.

[0042] In a 22nd embodiment according to the previous embodiment, the second site (32) is disposed in a bubble trap (19), the third end (63c) of the injection line (63) is fluidly connected to the bubble trap (19), and the loop recirculation circuit (11) further comprises the bubble trap (19).

[0043] In a 23rd aspect according to any one of the previous two aspects, the bubble trap (19) comprises: a blood inlet connected to the receiving part of the blood return line (7), the receiving part of the blood return line (7) being located between the outlet (2b) of the filtration unit (2) and the blood inlet of the bubble trap (19); a blood outlet connected to a secondary path of the blood return line (7), the secondary path of the blood return line (7) being located between the blood outlet of the bubble trap (19) and the second end (7b) of the return line (7); an auxiliary connection connected to the third end (63c) of the injection line (63); Includes.

[0044] In a 24th aspect according to any one of the previous aspects, the first site (31) is closer to the second end (6b) of the blood removal line (6) than to the first end (6a) of the blood removal line (6).

[0045] In a 25th embodiment according to any one of the previous embodiments, the disposable set further includes a pre-blood pump infusion line (51) extending from a first end (51a) for connection to a second fluid source (10) and a second end (51b) fluidly connected to the blood withdrawal line (6).

[0046] In a 26th embodiment according to the previous embodiment, the second end (51b) of the pre-blood pump infusion line (51) is positioned between the second end (6b) of the blood withdrawal line (6) and the blood pump path (6p) and / or between the second end (6b) of the blood withdrawal line (6) and the first site (31).

[0047] In a 27th aspect according to any one of the previous two aspects, the pre-blood pump infusion line (51) includes a respective PBP infusion pump path (51p) configured to be engaged by a PBP infusion pump (54), and in particular, the PBP infusion pump (54) is configured to facilitate infusion of a substance via the pre-blood pump infusion line (51).

[0048] In a 28th embodiment according to any one of the previous two embodiments, the second end (63b) of the infusion line (63) is directly connected to the pre-blood pump infusion line (51), in particular directly connected downstream of the PBP infusion pump path (51p) of the pre-blood pump infusion line (51) configured to be engaged by the PBP infusion pump (54).

[0049] In a 29th embodiment according to any one of the previous three embodiments, the infusion line (63) and the pre-blood pump infusion line (51) are connected to each other to form a common infusion path extending to the first site (31) of the blood removal line (6), and the loop recirculation circuit (11) includes the common infusion path.

[0050] In a 30th aspect according to any one of the previous four aspects, the disposable set further includes a pressure detection site (52a) arranged on the pre-blood pump infusion line (51) between the PBP infusion pump path (51p) of the pre-blood pump infusion line (51) and the second end (51b) of the pre-blood pump infusion line (51), and in particular, the pressure detection site (52a) is a pressure pod.

[0051] In a thirty-first embodiment according to the previous embodiment and the twenty-seventh embodiment, the pressure sensing site (52a) is disposed between the PBP infusion pump path (51p) and the second end (63b) of the infusion line (63).

[0052] In a 32nd embodiment according to any one of the previous six embodiments, the pre-blood pump infusion line (51) is an anticoagulant infusion line, and in particular, the second fluid source (10) comprises a PBP bag containing citrate and / or citric acid.

[0053] In a 33rd embodiment according to any one of the previous embodiments, the filtration unit (2) comprises: a primary chamber (3) fluidly connected to the blood circuit via the blood inlet and blood outlet of the filtration unit (2); a secondary chamber (4) fluidly connected or connectable to the fluid circuit (16), the secondary chamber (4) being configured to receive dialysate and / or remove effluent, The primary chamber (3) is separated from the secondary chamber (4) by a semi-permeable membrane (5).

[0054] In a thirty-fourth aspect according to any one of the previous aspects, the disposable set comprises: an effluent line (13) extending between a first end for connection to an evacuation unit, such as a collection container (62), and a second end fluidly connected to a liquid outlet of the secondary chamber (4) of the filtration unit (2), the effluent line (13) including an evacuation pump path (13p) configured to be engaged with an evacuation pump (26) of the extracorporeal blood treatment device to facilitate the flow of effluent from the liquid outlet of the secondary chamber (4) towards the evacuation unit; Optionally, the system further includes a fluid circuit (16) including a fluid supply line (8) extending between a first end for connection to a dialysate source (14) and a second end fluidly connected to a fluid inlet of the secondary chamber (4) of the filtration unit (2), the fluid supply line (8) including a supply pump path (8p) configured to be engaged with a supply pump (25) of the extracorporeal blood treatment device to promote dialysate toward the fluid inlet of the secondary chamber (4) of the filtration unit (2).

[0055] In a thirty-fifth embodiment according to the previous embodiment, the liquid supply line (8) branches into a post-infusion path (58) that extends to the return line (7) of the blood circuit (17) so that the liquid supply line (8) is selectively fluidly connectable to the return line (7).

[0056] In a thirty-sixth embodiment according to the previous embodiment, the post-infusion path (58) is connected to a bubble trap (19) disposed on the blood return line (7).

[0057] In a thirty-seventh embodiment according to any one of the previous two embodiments, the third path (69) of the injection line (63) and the post-injection path (58) of the liquid supply line (8) share a common terminal line path.

[0058] In a thirty-eighth embodiment according to any one of the previous three embodiments, the post-injection path (58) of the liquid supply line (8) is fluidly connected to the second site (32).

[0059] In a thirty-ninth embodiment according to any one of the previous five embodiments, the liquid supply line (8) includes an intake branch (57) extending to the filtration unit (2).

[0060] In a fortieth aspect according to any one of the previous six aspects, the disposable set comprises: on the discharge line (13) between the filtration unit (2) and the discharge pump path (13p), and / or - further comprising a pressure detection site (60a) arranged on the supply line (8) between the supply pump (25) and the filtration unit (2), optionally on the intake branch (57); In particular, the pressure sensing site (60a) is a pressure pod.

[0061] In a forty-first embodiment according to any one of the previous seven embodiments, the fluid circuit (16) includes a dialysate source (14) connected to the supply line (8), the dialysate source (14) including a bag containing dialysate.

[0062] In a forty-second embodiment according to any one of the previous embodiments, the disposable set further comprises an ion exchange container (73) and an ion exchange liquid line (74) connected to the ion exchange container (73) and the blood return line (7), optionally to an access site (18) located downstream of the second site (32).

[0063] In a forty-third embodiment according to any one of the previous embodiments, the disposable set does not include a one-way valve at the first site (31) and / or the second site (32).

[0064] In a 44th embodiment according to any one of the previous embodiments, the loop recirculation circuit (11) includes a bubble trap (19).

[0065] In a forty-fourth two-part embodiment according to any one of the previous aspects, the disposable set further includes a blood warming disposable unit, such as a flexible bag or rigid container having a blood flow path with an inlet and an outlet for a liquid, the blood warming disposable unit being fluidly connected to the blood circuit (17) upstream of the second site (32), in particular, the inlet of the blood warming disposable unit being fluidly connected to an upstream segment of the blood return line (7) and the outlet of the blood warming disposable unit being fluidly connected to a downstream segment of the blood return line (7), both fluid connections being upstream of the second site (32).

[0066] In the forty-fourth three embodiment according to the forty-fourth two embodiment, the blood warming disposable unit is included in the loop recirculation circuit (11). In this way, the blood in the warmer bag remains in motion during the recirculation procedure.

[0067] In a forty-fourth embodiment according to the forty-fourth second or third embodiment, the blood warming disposable unit is arranged upstream of the bubble trap (19).

[0068] In a forty-fifth aspect according to any one of the previous aspects, the blood pump passage (6p) is configured to be engaged with a peristaltic blood pump (21).

[0069] In a forty-sixth aspect according to any one of the previous aspects when according to the sixteenth aspect, the infusion pump passage (65p) of the infusion line (63) is configured to be engaged by a peristaltic infusion pump (65).

[0070] In a forty-seventh aspect according to any one of the previous aspects, the disposable set is engageable with an extracorporeal blood treatment device such as a CRRT device, a hemodialysis (HD) device, an ultrafiltration (UF) device, a hemofiltration (HF) device, a hemodiafiltration (HDF) device configured to perform hemodiafiltration therapy, an adsorption device, a carbon dioxide removal (ECCO2R) device, a therapeutic plasma exchange (TPE) or a blood oxygenation device.

[0071] In a forty-eighth aspect according to any one of the preceding aspects, the first site (31) is located between the second end (6b) of the blood removal line (6) and the filtration unit (2), in particular, the first site (31) is not in the same location as the second end (6b) of the blood removal line (6); The second site (32) is located between the filtration unit (2) and the second end (7b) of the blood return line (7), and in particular, the second site (32) is not in the same location as the second end (7b) of the blood return line (7).

[0072] In a forty-ninth aspect according to any one of the preceding aspects, The first site (31) is different from the second end (6b) of the blood removal line (6), The second site (32) is different from the second end (7b) of the blood return line (7).

[0073] In a 50th embodiment according to any one of the previous embodiments, the loop recirculation circuit (11) does not include the second end (6b) of the blood removal line (6) and the second end (7b) of the blood return line (7).

[0074] In a 51st embodiment according to any one of the previous embodiments, the device further includes a safety valve (27) arranged on the blood removal line (6) between the second end (6b) of the blood removal line (6) and the first site (31).

[0075] In a 52nd embodiment according to any one of the previous embodiments, the device further includes a safety valve (20) disposed on the blood return line (7) between the second site (32) and the second end (7b) of the blood return line (7).

[0076] In a 53rd embodiment according to any one of the previous embodiments, the disposable set further comprises a loop recirculation circuit (11) which is a closed circuit.

[0077] Two further aspects, 54 to 73, relate to devices for extracorporeal blood treatment according to the previous aspects 1 and 4, although the relevant features disclosed herein may be combined with features of disposable sets according to the previous aspects as well as when combined with the device.

[0078] In a fifty-fourth aspect according to any one of the previous aspects, the control unit (12) - defining a loop recirculation circuit (11), > defining a loop recirculation circuit (11) by commanding one or more intercept elements (20, 27, 59, 70) to fluidly communicate between the first site (31) and the second site (32) via at least the recirculation portion (66) of the inlet line (63); - controlling the blood pump (21) to determine the blood flow in at least the loop recirculation circuit (11) of the blood circuit (17) of the disposable set; and performing a recirculation procedure including:

[0079] The safety valves (20 and / or 27) on the blood circuit 17 may remain open, for example, in the event that the patient's vascular access becomes completely occluded.

[0080] Furthermore, the safety valves 20, 27 on the blood circuit 17 may also be left open in the case of a partial access occlusion scenario, and then the control unit (12) still controls the blood pump (21) to determine the blood flow in the loop recirculation circuit (11) of the blood circuit (17) of the disposable set, but in addition, blood circulation is maintained in the blood circuit sections between the second site (32) and the patient and between the patient and the first site (31). Indeed, in the latter scenario where the occlusion is not "total / total", a small amount of blood flow "q" can be taken from the catheter at the second end (6b) and returned to the second end (7b), while the recirculation flow "Q b -q" are present in the infusion line branches, i.e., the second and third paths (68 and 69).

[0081] In a fifty-fourth aspect according to any one of the preceding aspects, the control unit (12) > defining a loop recirculation circuit (11) by commanding one or more intercepting elements (20, 27, 59, 70) to prevent the passage of liquid through at least one of the blood removal line (6) between the second end (6b) of the blood removal line (6) and the first site (31) and the blood return line (7) between the second site (32) of the blood return line (7) and the second end (7b); and performing a recirculation procedure including:

[0082] In a fifty-fifth aspect according to any one of the previous aspects, the one or more intercept elements (20, 27, 59, 70) are an intercept element (70) acting on an infusion line (63), a recirculation position in which the intercept element (70) is configured to allow fluid communication between the first site (31) and the second site (32) via the recirculation portion (63) of the injection line (63); a locked position in which the intercept element (70) is configured to prevent fluid communication between the first site (31) and the second site (32) via the recirculation portion (63) of the injection line (63); an intercept element (70) movable between In a recirculation procedure, the control unit (12) is configured to switch the intercept element (70) to a recirculation position.

[0083] In particular, before initiating a recirculation procedure, the control unit (12) is configured to switch the intercept element (70) to the recirculation position and to maintain the intercept element (70) in the recirculation position during the recirculation procedure.

[0084] In a fifty-fifth aspect according to the previous aspect, the control unit (12) is not configured to stop the blood pump (21) before starting the recirculation procedure, and finally, the control unit (12) is configured to change the blood pump speed before starting the recirculation procedure.

[0085] In a fifty-sixth aspect according to any one of the previous two aspects, in the locked position, the control unit (12) is configured to instruct the intercept element (70) to prevent the passage of liquid towards either or both of the second end (63b) and the third end (63c) of the injection line (63).

[0086] In a fifty-seventh aspect according to any one of the previous aspects, the one or more intercepting elements (20, 27, 59, 70) comprise: a first safety valve (20) operating on the blood removal line (6) and arranged between the second end (6b) of the blood removal line (6) and the first site (31), the first safety valve (20) being arranged closer to the patient than the first site (31); a second safety valve (27) operating on the blood return line (7) and arranged between the second end (7b) of the blood return line (7) and the second site (32), in particular the second safety valve (27) being arranged closer to the patient than the second site (32); and The first safety valve (20) and / or the second safety valve (27) an open position allowing the passage of blood through the blood removal line (6) and the blood return line (7), respectively; a closed position in which the passage of blood through the blood removal line (6) and the blood return line (7) is prevented, respectively; It is possible to move between

[0087] In a fifty-seventh aspect according to the previous aspect, the control unit (12) is configured to maintain the first safety valve (20) and / or the second safety valve (27) in an open position during a recirculation procedure.

[0088] In a fifty-seventh aspect three according to the previous aspect 57, in the recirculation procedure, the control unit (12) is configured to move the first safety valve (20) and / or the second safety valve (27) to a closed position to prevent the passage of liquid.

[0089] In a fifty-eighth aspect according to any one of the preceding aspects, the one or more pumps (21, 25, 26, 54, 65, 75) include an infusion pump (65) operating on an infusion pump path (63p) of the infusion line, and in the recirculation procedure, the control unit (12) is configured to keep the infusion pump (65) inactive, and in particular, the infusion pump (65) is an occlusion pump such as a peristaltic pump.

[0090] In a fifty-eighth aspect according to any one of the previous aspects, the control unit (12) is configured to stop the blood pump (21) before starting the recirculation procedure.

[0091] In a fifty-ninth embodiment according to the previous embodiment, an infusion pump (65) operates on the infusion line (63) and is disposed between a first end (63a) of the infusion line (63) and the branch site (67) upstream of the branch site (67).

[0092] In a fifty-ninth aspect according to any one of the preceding aspects, after stopping the blood pump (21) and before starting the recirculation procedure, the control unit (12) is configured to increase the blood level in the bubble trap (19), in particular to avoid recirculation of air bubbles.

[0093] In a sixtieth aspect according to any one of the previous aspects, during the recirculation procedure, the control unit (12) is configured to stop ultrafiltration of the liquid from the primary chamber (3) to the secondary chamber (4) of the filtration unit (2).

[0094] In a sixty-first embodiment according to any one of the previous embodiments, during the recirculation procedure the control unit (12) is configured to keep the patient (P) fluidly isolated from the recirculation circuit (11).

[0095] In a 61st aspect according to any one of the previous 1 to 60 aspects, during the recirculation procedure the control unit (12) is not configured to keep the patient (P) fluidly isolated from the loop recirculation circuit (11).

[0096] In a 62nd aspect according to any one of the previous aspects, during the recirculation procedure, the control unit (12) is configured to recirculate blood in the loop recirculation circuit (11) to prevent the blood from clotting.

[0097] In a sixty-third aspect according to any one of the previous aspects, during the recirculation procedure, the control unit (12) is configured to interrupt the extracorporeal blood therapy.

[0098] In a 64th aspect according to any one of the previous aspects, the loop recirculation circuit (11) optionally defines a closed internal volume, and the control unit (12) is configured to recirculate the blood flow during a recirculation procedure.

[0099] In a 65th embodiment according to any one of the previous embodiments, the disposable set further includes a pre-blood pump infusion line (51) extending from a first end (51a) for connection to a second fluid source (10) and a second end (51b) fluidly connected to the blood withdrawal line (6), and the one or more pumps (21, 25, 26, 54, 65, 75) include a PBP infusion pump (54) acting on the pre-blood pump infusion line (51).

[0100] In a 66th embodiment according to the previous embodiment, during the recirculation procedure, the control unit (12) is configured to keep the PBP infusion pump (54) inactive, and in particular, the PBP infusion pump (54) is an occlusion pump such as a peristaltic pump.

[0101] In a sixty-sixth aspect according to any one of the preceding aspects, the disposable set includes a blood warming disposable unit having a blood flow path with an inlet and an outlet, the blood warming disposable unit being fluidly connected to the blood circuit (17) upstream of the second site (32), in particular, the inlet of the blood warming disposable unit being fluidly connected to the blood return line (7) and the outlet of the blood warming disposable unit being fluidly connected to the blood return line (7) upstream of the second site (32); During a recirculation procedure, the control unit (12) is configured to recirculate the blood contained in the blood warming bag.

[0102] In a sixty-sixth embodiment according to the sixty-sixth aspect, during the recirculation procedure, the control unit (12) - Turn off the heat on the blood warming bag, or adjusting the setpoint temperature of the warming unit, in particular as a function of the patient's actual blood temperature or the patient's desired blood temperature, or as a default setting; It is configured as follows.

[0103] In a sixty-seventh aspect according to any one of the previous aspects, the control unit (12) is configured to determine an alarm condition of the apparatus and to initiate a recirculation procedure, preferably automatically, when an alarm condition is detected.

[0104] In a 68th embodiment according to the previous embodiment, when an alarm condition is detected, the control unit (12) is configured to stop the blood pump (21) and, optionally, close the second safety valve (20) on the blood return line (7) and / or the first safety valve (27) on the blood removal line (6).

[0105] In a sixty-ninth aspect according to any one of the previous two aspects, when an alarm condition is detected, the control unit (12) is configured to check whether an infusion fluid source (64) is available to the infusion line (63), and if the infusion fluid source (64) is not available, to provide an alarm and / or to abort the recirculation procedure.

[0106] In a seventieth aspect according to any one of the previous aspects, during the recirculation procedure, the control unit (12) is configured to operate the blood pump (21) at a speed different from the speed of the blood pump (21) during extracorporeal blood therapy.

[0107] In a seventieth aspect according to any one of the previous aspects, during the recirculation procedure the control unit (12) is configured to operate the blood pump (21) in the same direction as during extracorporeal blood therapy.

[0108] In a seventieth aspect according to any one of the previous aspects, the control unit (12) is configured to terminate the recirculation procedure when a user clears an alarm that triggers the recirculation procedure.

[0109] In a seventy-fourth aspect according to any one of the previous aspects, the control unit (12) is configured to terminate the recirculation procedure if the elapsed recirculation time is longer than a preset recirculation time, and optionally, the preset recirculation time is a function of the anticoagulation mode during the extracorporeal blood therapy.

[0110] In a seventy-fifth aspect according to any one of the preceding aspects, the control unit (12) is configured to request confirmation from the user, for example via a user interface, to resume treatment when the recirculation procedure is completed.

[0111] Alternatively, the user may choose to stop treatment (eg, to change disposable sets).

[0112] In a 71st aspect according to any one of the previous aspects, to terminate the recirculation procedure, the control unit (12) is configured to instruct one or more intercept elements (20, 27, 59, 70) to prevent fluid communication between the first site (31) and the second site (32) via the recirculation portion (66) of the injection line (63).

[0113] In a seventy-first two-part embodiment according to any one of the preceding aspects, to resume extracorporeal blood therapy after recirculation, the control unit (12) is configured to check the blood level in the bubble trap (19) and provide adjustments, if necessary, e.g., via the air pump (47), depending on, e.g., the pressure level during recirculation versus the return pressure operating point before the recirculation procedure.

[0114] In a 72nd aspect according to the previous 71st aspect, after preventing fluid communication between the first site (31) and the second site (32) via the recirculation section (66), the control unit (12) is configured to increase or decrease the blood pump (21) to a set flow rate for extracorporeal blood therapy.

[0115] In a seventy-third aspect according to any one of the previous two aspects, the control unit (12) a. moving the intercept element (70) acting on the injection line (63) to a locking position that allows the flow of liquid in a second path (68) extending from the branching site (67) to the second end (63b) of the injection line (63) and blocks the flow of liquid in a third path (69) extending from the branching site (67) to the third end (63c) of the injection line (63), thereby preventing fluid communication between the first site (31) and the second site (32) via the recirculation section (66); b. rinsing the blood in the second pathway (68) with fluid from the infusion line (63); It is configured as follows.

[0116] In a seventy-third aspect according to any one of the preceding three aspects, the control unit (12) - moving the intercept element (70) acting on the injection line (63) to a locking position in which it allows the flow of liquid in a third path (69) extending from the branching site (67) to the third end (63c) of the injection line (63) and blocks the flow of liquid in a second path (68) extending from the branching site (67) to the second end (63b) of the injection line (63), thereby preventing fluid communication between the first site (31) and the second site (32) via the recirculation section (66); - rinsing the blood in the third path (69) with liquid from the infusion line (63); It is configured as follows.

[0117] Further aspects 74 to 89 relate to methods of recirculating blood in an extracorporeal blood treatment device according to the previous aspect 3, although the relevant features disclosed herein may be combined with features of the disposable set and / or device dependent on the previous aspects, as well as when combined with the method aspects.

[0118] In a 74th aspect according to any one of the preceding aspects when combined with the third aspect of the method, the method comprises: Defining a loop recirculation circuit (11), defining a loop recirculation circuit (11) by commanding one or more intercept elements (20, 27, 59, 70) to fluidly connect the first site (31) and the second site (32) via at least the recirculation portion (66) of the inlet line (63); making it possible to determine the blood flow in the loop recirculation circuit (11) of the blood circuit (17) of the disposable set; Further includes:

[0119] In a seventy-fourth aspect according to the previous aspect, when combined with the third aspect of the method, defining the loop recirculation circuit (11) includes instructing one or more intercepting elements (20, 27, 59, 70) to prevent the passage of liquid in either or both of the blood removal line (6) between the second end (6b) of the blood removal line (6) and the first site (31), and the blood return line (7) between the second site (32) of the blood return line (7) and the second end (7b).

[0120] In a 74th embodiment according to the previous 74th embodiment, defining the loop recirculation circuit (11) includes instructing one or more intercepting elements (20, 27, 59, 70) to allow the passage of liquid in either or both of the blood removal line (6) between the second end (6b) of the blood removal line (6) and the first site (31), and the blood return line (7) between the second site (32) of the blood return line (7) and the second end (7b).

[0121] In a seventy-fourth embodiment according to the previous embodiment, the method includes controlling a blood pump (21) to determine blood flow in a loop recirculation circuit (11) of a blood circuit (17) of a disposable set, and additionally maintaining blood circulation in blood circuit sections between a second site (32) and a patient and between the patient and the first site (31), in particular, blood being collected at a second end (6b) of a blood removal line (6) and returned to a second end (7b) of a blood return line (7); A blood flow (q) is generated in the blood circuit (17) upstream of the first site (31) and downstream of the second site (32), and a recirculation flow (Qb -q) are present in the recirculation section (66) of the infusion line (63), i.e., the second and third paths (68 and 69), and in the remainder of the blood circuit (17), including the blood pump path (6p) and the filtration unit (2).

[0122] In a seventy-fifth aspect according to any one of the preceding four aspects seventy-four to seventy-four or the third aspect, the one or more intercept elements (20, 27, 59, 70) are an intercept element (70) acting on an infusion line (63), a recirculation position in which the intercept element (70) is configured to allow fluid communication between the first site (31) and the second site (32) via the recirculation portion (63) of the injection line (63); a locked position in which the intercept element (70) is configured to prevent fluid communication between the first site (31) and the second site (32) via the recirculation portion (63) of the injection line (63); an intercept element (70) movable between The method includes switching the intercept element (70) to a recirculation position before initiating a recirculation procedure, and maintaining the intercept element (70) in the recirculation position during the recirculation procedure.

[0123] In a 76th aspect according to any one of the previous two aspects or the third aspect, the one or more intercepting elements (20, 27, 59, 70) comprise: a first safety valve (20) operating on the blood removal line (6) and arranged between the second end (6b) of the blood removal line (6) and the first site (31); a second safety valve (27) operating on the blood return line (7) and arranged between the second end (7b) of the blood return line (7) and the second site (32); and The first safety valve (20) and / or the second safety valve (27) an open position allowing the passage of blood through the blood removal line (6) and the blood return line (7), respectively; a closed position in which the passage of blood through the blood removal line (6) and the blood return line (7) is prevented, respectively; It is movable between The method, instead, is - before the recirculation procedure, moving the first safety valve (20) and / or the second safety valve (27) to a closed position to prevent the passage of liquid, and during the recirculation procedure, maintaining the first safety valve (20) and / or the second safety valve (27) in a closed position; or - not switching the first safety valve (20) and / or the second safety valve (27) to a closed position, and maintaining the first safety valve (20) and / or the second safety valve (27) in an open position during the recirculation procedure; Includes.

[0124] In a 77th aspect according to any one of the previous 74 to 76 aspects or the 3rd aspect, the extracorporeal blood treatment device further comprises an infusion pump (65) engaged with the first infusion path (72) of the infusion line (63); The method is: - stopping or keeping the infusion pump (65) inactive; - allowing liquid circulation downstream of the branching site (67) in the recirculation section (66) of the injection line (63) and between the second site (32) and the first site (31); - stopping the infusion pump (65) and, after enabling the circulation, starting the blood pump (21) if it was previously stopped; Further includes:

[0125] In a seventy-seventh aspect according to any one of the preceding aspects, before starting the recirculation procedure, the control unit (12) a. Stop the blood pump (21); b. configured to operate the blood circuit (17) to reduce the pressure differential between the portions of the blood circuit (17) on either side of the blood pump (21) before switching the intercept element (70) to the recirculation position; In particular, to reduce the pressure difference, the control unit (12) is configured to perform at least one of the following actions: i. commanding one or more intercepting elements (20, 27, 59, 70) to switch from a closed to an open position to prevent or allow the passage of liquid through the blood removal line (6) between the second end (6b) of the blood removal line (6) and the first site (31) and / or the blood return line (7) between the second site (32) and the second end (7b) of the blood return line (7); ii. Inject the infusion fluid into the blood circuit (17) and adjust the access and / or return pressure so that they are close to each other, for example, a pressure difference of less than 100 mmHg.

[0126] Indeed, before starting the recirculation procedure, the access and return pressures differ from each other by a delta pressure, which must be reduced by bringing the access and return pressures closer together or to the same value.

[0127] In a seventy-seventh aspect according to any of the previous aspects, during extracorporeal blood therapy, the control unit (12) is configured to determine a therapy flow and control the injection of a replacement liquid through the second end (63b) of the injection line (63) into the blood in the blood withdrawal line (6) at the first site (31), and in particular, to control the injection of the replacement liquid through the second end (63b), the control unit (12) is configured to move an intercept element (70) acting on the injection line (63) to an injection position, and the intercept element (70) is configured to enable fluid communication between a first path (72) of the injection line (63) upstream of the intercept element and the first site (31).

[0128] In a 78th embodiment according to any one of the previous 74 to 77 embodiments or the 3rd embodiment, the method further comprises stopping ultrafiltration of liquid from the primary chamber (3) to the secondary chamber (4) of the filtration unit (2) during recirculation.

[0129] In a 79th aspect according to any one of the previous 74 to 78 aspects or the 3rd aspect, the method further comprises keeping the patient (P) fluidly isolated from the loop recirculation circuit (11) during recirculation.

[0130] In an 80th aspect according to any one of the previous 74 to 79 aspects or the 3rd aspect, the method further comprises not keeping the patient (P) fluidly isolated from the loop recirculation circuit (11) during recirculation.

[0131] In an 81st aspect according to any one of the previous 74 to 79 aspects or the 3rd aspect, the method further comprises recirculating the blood in a loop recirculation circuit (11) to prevent the blood from clotting during recirculation.

[0132] In an 82nd aspect according to any one of the previous 74 to 81 aspects or the 3rd aspect, the method further includes terminating the recirculation procedure when a user clears the alarm that triggered the recirculation procedure.

[0133] In an 83rd embodiment according to any one of the previous 74 to 82 embodiments or the 3rd embodiment, the method further comprises terminating the recirculation procedure if the elapsed recirculation time is longer than a preset recirculation time, optionally the preset recirculation time being a function of the anticoagulation mode during the extracorporeal blood therapy.

[0134] In an 84th aspect according to any one of the previous 74 to 83 aspects or the 3rd aspect, the method further comprises, once the recirculation procedure is completed, requesting confirmation from the user, e.g., via a user interface, to resume treatment, and / or requesting confirmation from the user, e.g., via a user interface, to stop treatment.

[0135] In an 85th aspect according to any one of the previous 74 to 84 aspects or the 3rd aspect, the method further comprises checking the blood level in the bubble trap (19) to resume extracorporeal blood therapy after recirculation and, if necessary, providing adjustments, e.g., via an air pump (47), e.g., depending on the pressure level during recirculation versus the return pressure operating point before the recirculation procedure.

[0136] In an 86th aspect according to any one of the previous 74 to 85 aspects or the third aspect, the method includes instructing one or more intercept elements (20, 27, 59, 70) to prevent fluid communication between the first site (31) and the second site (32) via the recirculation portion (66) of the injection line (63) to terminate the recirculation procedure.

[0137] In an 87th embodiment according to the 86th embodiment, the method further includes, after preventing fluid communication between the first site (31) and the second site (32) via the recirculation section (66), increasing or decreasing the blood pump (21) to a set flow rate for extracorporeal blood therapy.

[0138] In an 88th embodiment according to any one of the previous two embodiments, the method comprises: a. moving an intercept element (70) acting on the injection line (63) to a locked position that allows the flow of liquid in a second path (68) extending from the branching site (67) to the second end (63b) of the injection line (63) and blocks the flow of liquid in a third path (69) extending from the branching site (67) to the third end (63c) of the injection line (63) so as to prevent fluid communication between the first site (31) and the second site (32) via the recirculation section (66); b. rinsing the blood in the second pathway (68) with fluid from the infusion line (63); Includes.

[0139] In an 89th embodiment according to any one of the previous three embodiments, the method comprises: a. moving an intercept element (70) acting on the injection line (63) to a locking position that allows the flow of liquid in a third path (69) extending from the branching site (67) to the third end (63c) of the injection line (63) and blocks the flow of liquid in a second path (68) extending from the branching site (67) to the second end (63b) of the injection line (63) so as to prevent fluid communication between the first site (31) and the second site (32) via the recirculation section (66); b. rinsing the blood in the third pathway (69) with fluid from the infusion line (63); Includes. [Brief explanation of the drawings]

[0140] [Figure 1] FIG. 1 is a schematic diagram of the fluid lines of a disposable set coupled to the pumps, sensors and actuators of an associated device according to an embodiment of the present invention. [Figure 1a] FIG. 1a shows the scheme of FIG. 1 with the recirculation loop highlighted by the thicker lines. [Figure 2] FIG. 2 is a schematic diagram of the fluid lines of a disposable set coupled to the pumps, sensors and actuators of an associated device according to a second embodiment of the present invention. [Figure 2a] FIG. 2a shows the scheme of FIG. 2 with the recirculation loop highlighted by the thicker lines. [Figure 3] FIG. 3 shows a disposable set coupled to a pump, sensor and actuator of an associated device according to a third embodiment of the invention. [Figure 3a] FIG. 3a reflects the scheme of FIG. 3, with the recirculation loops highlighted schematically by thicker lines. [Figure 4] FIG. 4 shows a further embodiment of a disposable set attached to an associated treatment device according to a fourth embodiment of the invention. [Figure 4a] FIG. 4a reflects the scheme of FIG. 4, with the recirculation loops highlighted schematically by thicker lines. [Figure 5]FIG. 5 shows an alternative embodiment of a disposable set attached to an associated treatment device according to a fifth embodiment of the present invention. [Figure 5a] FIG. 5a reflects the scheme of FIG. 5, with the recirculation loops highlighted schematically by thicker lines. DETAILED DESCRIPTION OF THE INVENTION

[0141] definition In this detailed description, corresponding parts shown in the various figures are designated by the same reference standard. The figures may illustrate the invention by non-scale representations, and therefore, parts and components shown in the figures relevant to the purpose of the invention may relate only to schematic representations.

[0142] Upstream and downstream The terms upstream and downstream refer to the forward direction or trajectory of fluid or blood configured to flow through the lines of the disposable set during a typical blood therapy procedure, where blood is withdrawn from a patient at a first access site and circulated through the blood withdrawal line, filtration unit, and blood return line before being reinfused into the patient at a second access site. The infusion line directs the respective fluids to the extracorporeal blood circuit, and unused dialysate is supplied to the filtration unit (countercurrent to the blood) and removed via the discharge line to a drain.

[0143] Referring to Figure 1, reference numeral 1 generally refers to an extracorporeal blood treatment device, particularly, but not limited to, an extracorporeal blood treatment device for intensive care therapy. The extracorporeal blood treatment device of the present invention may perform any dialysis therapy, such as hemodialysis (HD), hemofiltration (HF), hemodiafiltration (HDF), or ultrafiltration (UF), as well as (C)RRT treatment; the device may alternatively / in addition be configured for ECC02R or oxygenation therapy, as well as for adsorption, liver therapy, hemoperfusion, or plasma exchange. The extracorporeal blood treatment device 1 is designed to accept a disposable set 100, as claimed herein and described below.

[0144] The device according to FIG. 1 is specifically (though not excessively) designed for renal replacement therapy (RRT), in particular continuous renal replacement therapy (CRRT). CRRT devices are configured to deliver highly specific therapy designed for patients who are acutely ill and have temporarily lost renal function. In this respect, CRRT systems may differ structurally and / or operationally from extracorporeal blood treatment systems designed for chronic patient care. CRRT systems must exhibit specific technical features that enable the system to: - Weight loss rate can be set, -Continuously removes excess fluid according to a set weight loss rate, -Continuous operation at relatively low flow rates compatible with CRRT; and -Balancing of ionic equilibrium by performing appropriate dialysis and / or by using substitution fluids delivered continuously at controlled flow rates.

[0145] Finally, in order to prepare the CRRT equipment as quickly as possible, taking into account the acute situation of the patient needing treatment and the lack of prior notice of the emergency situation requiring treatment, the CRRT machine is loaded using an integrated disposable set 100 in which all lines and filtration units are grouped together and already properly connected in the disposable set. Furthermore, all fluids are usually (but not necessarily) contained in pre-packaged bags (e.g., dialysate or substitution fluid in 2, 5, or 10 liter bags, respectively) or pre-packaged syringes (heparin and / or concentrated calcium substitution solutions).

[0146] Although the specifically described embodiments refer to extracorporeal blood treatment devices and disposable sets for acute treatment, the invention is not limited to such fields and may also be implemented and used in devices for chronic patient treatment.

[0147] Reference number 100 relates to a disposable set for an extracorporeal blood treatment device. The disposable set 100, shown schematically in Figures 1 to 5, comprises blood and liquid lines, respectively, configured to be engaged with the treatment device 1, the latter comprising, for example, peristaltic pumps for facilitating the flow of liquid and blood.

[0148] The disposable set 100 comprises at least one filtration unit 2 configured to treat blood drawn from a patient. The filtration unit 2 can be any kind of filter for treating blood, such as a filter for performing hemodialysis (HD), ultrafiltration (UF), hemofiltration (HF) and hemodiafiltration (HDF), a filter for hemoperfusion, a plasma filter, an adsorber, etc.

[0149] 1 and 2, in certain embodiments, filtration unit 2 has a primary chamber 3 and a secondary chamber 4 separated by a semipermeable membrane 5, where primary chamber 3 receives blood drawn from a patient and secondary chamber 4 receives filtered waste products from the blood and discharges them via a liquid outlet connected to a discharge line 13. Depending on the process, membrane 5 of filtration unit 2 may be selected to have different properties and performance.

[0150] The blood circuit 17 includes a blood removal line 6 extending between a first end 6a connected to the blood inlet 2a of the primary chamber 3 of the filtration unit 2 and a second end 6b connected to the patient P. The blood removal line 6 is configured to receive blood from the patient P and allow blood circulation along a withdrawal direction 200 from the second end 6b of the blood removal line 6 toward the first end 6a and into the filtration unit 2.

[0151] The blood circuit 17 further includes a blood return line 7 extending between a first end 7a connected to the blood outlet 2b of the primary chamber 3 of the filtration unit 2 and a second end 7b for connection to the patient P. The blood return line 7 is configured to receive (treated) blood from the blood outlet 2b of the filtration unit 2 and allow blood circulation along a return direction from the first end 7a to the second end 7b of the blood return line 7. The blood removal line 6 and the blood return line 7 are typically made of a flexible material, such as PVC or a plastic-based material, and may be transparent so that an operator can see the blood flowing through the lines. The blood circuit 17 further includes a pump path 6p configured to engage with a blood pump 21 of the extracorporeal blood device to promote blood flow in the blood removal line 6 and the blood return line 7. The pump path 6p may be disposed on the blood removal line 6 or the blood return line 7. Alternatively, the blood circuit 17 may include two blood pumps, with a first blood pump engaged with the blood removal line 6 and a second blood pump engaged with the blood return line 7 (this embodiment is not shown). Note that the pump symbols in the figures do not necessarily indicate the direction of flow in the respective pump pathways. In general, each and every (e.g., peristaltic) pump may be controlled in one direction and in the other, depending on the needs of the device and treatment.

[0152] 1 to 5, the blood withdrawal line 6 includes a pumping path 6p that is engaged by a blood pump 21 of the extracorporeal blood treatment device. The blood pump 21 is configured to direct blood flow from the second end 6b of the withdrawal line in a direction 200 toward the filtration unit 2 and then back to the blood return line 7.

[0153] As shown in the figure in the first example, the blood pump path 6p may be a portion of the blood removal line 6 itself, disposed between the first end 6a and the second end 6b of the blood removal line 6. The blood pump path 6p may differ from the other line paths of the blood removal line 6 in terms of dimensions (e.g., passage section and / or wall thickness) and / or material. In particular, the blood pump path 6p may have an outer dimension or diameter larger than the outer dimension or diameter of the first and / or second paths of the blood removal line 6. Additionally or alternatively, the blood pump path 6p may have an inner dimension or diameter defining a liquid passage of the blood pump path 6p that is larger than the inner dimension or diameter of the first and / or second paths of the blood removal line. The blood pump pathway 6p may be a separate and distinct tubing segment relative to the other pathways of the blood removal line 6, and the blood pump pathway 6p may be engaged / coupled to the other pathways by a bonding or welding process during the manufacturing process of the disposable set 100 (and / or a suitable connector may be inserted between the end of the pump pathway and the other tubing section of the blood removal line to join the respective ends).

[0154] The blood pump path 6p may also be curved (e.g., Ω-shaped) and / or have elastic properties different from those of the first and other line paths of the blood removal line 6; for example, the blood pump path 6p may be more flexible than the other line paths of the blood removal line 6 to withstand fatigue stresses caused by the peristaltic pump 21 of the blood treatment device.

[0155] Alternatively, the blood pump path 6p may be a disposable pump header connected to the pump body by, for example, magnetic coupling. The blood pump 21 may be a centrifugal pump, as may be the case for centrifugal pumps used in ECMO circuits, for example.

[0156] During treatment, the blood removal line 6 and the blood return line 7 are directly or indirectly connected to the patient's blood cardiovascular system via access devices such as needles, catheters, or artificial blood vessels. Typically, in renal replacement treatment, the blood removal line 6 and the blood return line 7 are directly connected to the patient's blood cardiovascular system; however, in certain situations, such as when the patient is undergoing cardiopulmonary bypass and is therefore already connected to an ECMO machine, the blood removal line 6 and the blood return line 7 may be connected to the ECMO extracorporeal blood line and, as a result, indirectly connected to the patient's blood cardiovascular system (via the ECMO blood line).

[0157] The device 1 includes a blood pump 21 for controlling blood flow within the blood circuit 17. The blood pump 21 is typically a peristaltic pump acting on either the blood removal line 6 (e.g., as shown in FIGS. 1-5) and / or the blood return line 7 (embodiment not shown). An operator may input a blood flow rate setting via the user interface 15, and the control unit 12 is configured to control the blood pump during treatment based on the set blood flow rate.

[0158] Blood is drawn from the patient via the vascular access system and flows through the blood withdrawal line 6. After passing through the primary chamber 3 of the filtration unit 2, where appropriate exchange of substances, molecules, and liquids occurs via the semipermeable membrane 5, the treated blood enters the blood return line 7 and first passes through an air separator, commonly known as a "bubble trap" 19, designed to ensure the removal of any air bubbles present in the blood. Before being returned to the patient P, the treated blood exiting the bubble trap 19 passes through an air bubble sensor 55 to verify the absence of air bubbles in the treated blood, which must be reintroduced into the patient's vascular circuit via the venous access system. A safety valve 20 (or venous clamp) is provided downstream of the air bubble sensor 55. The safety valve 20 blocks blood flow toward the patient in the event of an alarm requiring the blood pump to be stopped and the patient to be isolated. For example, if the air bubble sensor 55 detects the presence of air / gas in the bloodstream, the control unit 12 controls the safety valve 20 to a closed position to prevent air from being infused into the patient.

[0159] A corresponding safety valve 27 (or arterial clamp) may be present on the blood removal line 6 close to the patient's vascular access to completely isolate the patient from the extracorporeal blood circuit if necessary.

[0160] The safety valve 27 of the blood removal line 6 and the safety valve 20 of the blood return line 7 may both be configured in a closed position such that the patient P is fluidly isolated from the blood circuit 17 of the disposable set. The safety valve 27 of the blood removal line 6 and the safety valve 20 of the blood return line 7 may be manually controllable, but are typically automatically controllable by the control unit 12 between a closed position and an open position, or vice versa.

[0161] The disposable set 100 further includes an infusion line 63 extending from a first end 63a for connection to an infusion fluid source 64, and a branch site 67 branching from the infusion line 63 toward a second end 63b and toward a third end 63c. A portion of the infusion line 63 disposed between the second end 63b and the third end 63c of the infusion line 63 defines a recirculation portion 66 of the infusion line, as described in more detail herein below.

[0162] Fluid source 64 is a source of infusion or substitution fluid. In particular, fluid source 64 may be a plastic bag containing a pre-packaged substitution fluid solution.

[0163] The second end 63b of the infusion line 63 is in direct or indirect fluid communication with the blood removal line 6 at the first site 31. Direct fluid communication between the infusion line 63 and the blood removal line 6 means that the infusion line 63 is directly connected to the blood removal line 6, and the liquid exiting the second end 63b of the infusion line 63 enters directly into the blood flow through the blood removal line 6 of the blood circuit 17.

[0164] Indirect fluid communication between the infusion line 63 and the blood removal line 6 means that the infusion line 63 is not directly connected to the blood removal line 6, but is directly connected to another fluid line (e.g., the PBP line 51) which is itself directly connected to the blood removal line 6. As a result, the infusion fluid leaving the second end 63b of the infusion line 63 enters the other fluid line and then reaches the blood removal line 6 at the other line's injection point into the blood removal line 6.

[0165] As explained further below, examples of direct fluid communication are shown in Figures 1 and 1a (and 4, 4a, 5, 5a), and examples of indirect fluid communication are shown in Figures 2 and 2a (and 3, 3a).

[0166] The first site 31 is located on the blood circuit 17, specifically, on the blood removal line 6, and is disposed between the blood pump path 6p and the second end 6b of the blood removal line 6. Although not required, the first site 31 can be disposed as close as possible to the patient so that the remaining portion of the blood removal line 6 between the first site 31 and the patient is as short as possible. The first site 31 is upstream of the blood pump path 6p with respect to the withdrawal direction 200.

[0167] As will be apparent, the first site 31 may or may not coincide with the second end 63b of the infusion line 63. In some embodiments, the first site 31 coincides with the location where the second end 63b of the infusion line 63 (directly) connects to the blood removal line 6 (e.g., FIG. 1), while in other embodiments the first site 31 (on the blood removal line 6) may be separate and spatially separated from the second end 63b of the infusion line 63 (e.g., FIG. 2).

[0168] The first site 31 may include a liquid connector, i.e., a three-way liquid connector, including a blood inlet that is (directly) fluidly connected to the withdrawal line 6 and facing the second end 6b of the blood withdrawal line 6, a blood outlet that is (directly) fluidly connected to the blood withdrawal line 6 and facing the first end 6a of the blood withdrawal line 6, in particular facing the pump path 6p of the blood withdrawal line 6, and an inlet that is (directly or indirectly) fluidly connected to the second end 63b of the infusion line 63.

[0169] The liquid connector may be made of a plastic material that is harder than the material of the infusion line 63 and / or the blood removal line 6. Conversely, the infusion line 63 is flexible, and in particular more flexible than the liquid connector. Similarly, the blood removal line 6 is more flexible than the liquid connector. In particular, the first site 31 is separate and spatially separated from the second end 6b of the blood removal line 6.

[0170] The third end 63c of the infusion line 63 is in direct or indirect fluid communication with the blood return line 7 at the second site 32. The second site 32 is disposed between the blood pump path 6p and the second end 7b of the blood return line 7. In particular, when the blood pump path 6p is on the blood removal line 6, the second site 32 is disposed between the blood outlet 2b of the filtration unit 2 and the second end 7b of the return line 7.

[0171] The second site 32 may include a liquid connector, i.e., a three-way liquid connector, including a blood inlet that is (directly) fluidly connected to the return line 7 and facing the first end 7a of the blood return line 7, a blood outlet that is (directly) fluidly connected to the return line 7 and facing the second end 7b of the blood return line 7, and an injection inlet that is (directly or indirectly) fluidly connected to the third end 63c of the injection line 63.

[0172] According to the embodiment shown in FIGS. 1 and 2 , the bubble trap 19 may be located at a second site 32 disposed on the blood return line 7. The bubble trap 19 includes a blood inlet fluidly connected (directly) to the return line 7 and facing the first end 7a of the blood return line 7, a blood outlet fluidly connected (directly) to the return line 7 and facing the second end 7b of the blood return line 7, and an inlet fluidly connected (directly) to the third end 63c of the inlet line 63. The bubble trap 19 is configured to separate air / gas from the blood flow to prevent bubbles from flowing toward the patient. In particular, the second site 32 is distinct and spatially separated from the second end 7b of the blood return line 7.

[0173] As previously mentioned, the infusion line 63 extends from its first end 63a to a bifurcation site 67 for a first pathway 72, where the first pathway 72 bifurcates into a second pathway 68 extending from the bifurcation site 67 to a second end 63b of the infusion line 63, and a third pathway 69 extending from the bifurcation site 67 to a third end 63c of the infusion line 63. The recirculation portion 66 of the infusion line 63 includes the second pathway 68 and the third pathway 69 of the infusion line 63 (which may be fully defined by - in the case of Figures 1, 1a, 4, 4a, 5, and 5a).

[0174] The infusion line 63 further includes a respective infusion pump pathway 65p disposed between the first end 63a of the infusion line 63 and the bifurcation site 67, the infusion pump pathway 65p of the infusion line 63 being configured to be engaged by a respective infusion pump 65, i.e., an occlusion pump such as a peristaltic pump, of the extracorporeal blood treatment device configured to cause fluid to flow in a direction from the first end 63a of the infusion line towards the bifurcation site 67. The infusion pump pathway 65p includes the same technical features as described above, which distinguish the blood pump pathway 6p from the other pathways of the blood removal line 6.

[0175] Correspondingly, the device 1 includes an infusion pump 65 (in this example a peristaltic pump) engaged with the infusion line 63 and configured to determine the flow rate along the line of the substance contained in the infusion fluid source 64, i.e., substitution fluid, during infusion.

[0176] The extracorporeal blood treatment device 1 may further comprise a selector 70 operating on the infusion line 63 at the branch site 67. The selector 70 comprises (at least) a first operating position (pre-injection) in which the selector 70 allows fluid communication between the first path 72 and the second path 68 of the injection line 63 and prevents fluid communication between the first path 72 and the third path 69 of the injection line 63; a second operating position (post-injection), in which the selector 70 prevents fluid communication between the first path 72 and the second path 68 of the injection line 63 and allows fluid communication between the first path 72 and the third path 69 of the injection line 63; a recirculation position (neutral position) in which the second path 68 and the third path 69 of the injection line 63 are in fluid communication with each other; It may be possible to switch between

[0177] In particular, when selector 70 is in the recirculation position, both second path 68 and third path 69 of infusion line 63 define recirculation portion 66 of loop recirculation circuit 11. Furthermore, when selector 70 is in the recirculation position, first site 31 is in fluid communication with second site 32 via recirculation portion 66. In other words, in the recirculation position, selector 70 (which may be a valve that clamps either second path 68 or third path 69, or acts on neither path 68, 69) does not act on (clamps) any tubing portions and is in a neutral position away from second and third paths 68, 69.

[0178] In the recirculation position, no liquid flows along the first path 72 of the infusion line 63. For example, the infusion pump 65 may be an occlusion pump, thereby preventing any flow, or a clamp, the same selector 70, or another device may prevent flow in the first path 72, for example, by closing it.

[0179] Alternatively, in either the first or second operating position, fluid flows from the first path 72 towards the second and / or third paths 68, 69 to infuse substitution fluid into the blood circuit. In this situation, cooperation between the actuated infusion pump 65 and the selector 70 can simultaneously define the amount of fluid before infusion and the amount of fluid after infusion.

[0180] Of course, if only pre-infusion or post-infusion is manageable at a time (i.e., either 100% pre-infusion or 100% post-infusion), the selector 70 prevents fluid communication between the first site 31 and the second site 32 via the recirculation portion 66 of the loop recirculation circuit 11. In particular, in the first operating position, fluid passage from the fluid source 64 to the second pathway 68 is permitted, while fluid passage from the fluid source 64 to the third pathway 69 is prevented. Conversely, in the second operating position, fluid passage from the fluid source 64 to the third pathway 69 is permitted, while fluid passage from the fluid source 64 to the second pathway 68 is prevented. In particular, the first and second operating positions may be assumed before or after infusing substitution fluid into the extracorporeal blood circuit during standard dialysis therapy, while the recirculation position of the selector 70 is assumed to allow fluid recirculation in the recirculation state.

[0181] The selector 70 may consist of a valve element that operates on the infusion line 63 by alternatively blocking the passage of liquid in either branch and that can further be placed in a neutral position. Alternatively, a suitable selector may be provided that allows a priori to establish the amount of liquid that must pass through both branches simultaneously. It is also possible to vary the proportion of liquid in either branch as a function of time and a pre-established treatment. In particular, the selector 70 is connected to the control unit 12, which is configured to selectively control the selector in a first operating position, a second operating position, and a recirculation position.

[0182] The disposable set may further include a pre-blood pump (PBP) infusion line 51 extending from a first end 51a for connection to a second fluid source 10, and a second end 51b fluidly connected to the blood withdrawal line 6. The pre-blood pump infusion line 51 may be an anticoagulant infusion line 51, in which case the second fluid source 10 may contain a liquid solution including citrate and / or citric acid. The second fluid source 10 may be a plastic bag containing PBP infusion liquid.

[0183] As shown in FIGS. 1 and 2, the second end 51b of the pre-blood pump infusion line 51 is disposed between the second end 6b of the blood removal line 6 and the blood pump path 6p.

[0184] Furthermore, the second end 51b of the pre-blood pump infusion line 51 may be located between the second end 6b of the blood removal line 6 and the first site 31, as shown in Figure 1, if the infusion line 63 is directly connected to the blood removal line 6. Indeed, in such a case, the connection between the second end 63b of the infusion line 63 and the withdrawal line is optionally downstream of the second end 51b of the pre-blood pump infusion line 51.

[0185] The pre-blood pump infusion line 51 also includes a respective PBP (pre-blood pump) infusion pump path 51p configured to be engaged by a respective PBP infusion pump 54 configured to inject a substance from the second fluid source 10 into the blood circuit 17 via the pre-blood pump infusion line 51.

[0186] The PBP infusion pump 54 is operably connected to a controller 12 configured to selectively control the PBP infusion pump 54 to facilitate flow of infusion fluid through the infusion line 51 and deliver the infusion fluid into the drainage line 6, and the controller 12 may be configured to control the PBP infusion pump 54 to set a prescribed flow rate. Also in this regard, the type of therapy, the contents of the infusion bag, and other conditions determine the set infusion rate. The control unit may also be configured to stop the PBP infusion pump 54 to stop the supply of infusion fluid.

[0187] 2 and 3, the second end 51b of the pre-blood pump infusion line 51 is connected to the blood removal line 6 at the first site 31. In this case, the second path 68 of the infusion line 63 is directly connected to the pre-blood pump infusion line 51 at an access point 51c located between the second end 51b of the pre-blood pump infusion line 51 and the PBP infusion pump path 51p of the pre-blood pump infusion line 51. In other words, the infusion line 63 and the pre-blood pump infusion line 51 are connected to each other at the access point 51c, and fluid travels toward the blood removal line 6 along a common infusion path extending to the first site 31 (i.e., the common infusion path extends from the access point 51c to the second end 51b of the pre-blood pump infusion line 51).

[0188] The disposable set further includes an ion exchange fluid line 74 connected at one end to the ion exchange container 73 and at the other end to the blood return line (7) via an access site 18, such as a connector, that allows for infusion and uniform mixing of the infused fluid with blood. As shown in the enclosed figure, the access site 18 is located downstream of the second site 32 and possibly, but not necessarily, upstream of the air bubble sensor 55. An ion exchange pump 75 acting on an ion exchange pump path 75p allows for pumping fluid through the ion exchange infusion line 74.

[0189] In an alternative embodiment (not shown), the ion exchange infusion line 74 is connected directly to an additional patient vascular access that infuses the ion exchange fluid directly into the patient's blood (e.g., into the patient's venous peripheral vessels).

[0190] Typically, the ion exchange infusion line 74 is used to infuse a concentrated calcium (and sometimes magnesium) solution to re-establish the proper electrolyte balance in the patient's blood during treatment with citrate-based regional anticoagulation therapy.

[0191] According to the disclosed embodiment, the disposable set 100 further includes a fluid supply line 8. The fluid supply line 8 supplies dialysate to the filtration unit 2 from a dialysate source 14. The dialysate source 14 consists of one or more bags containing a suitable dialysate designed to supply the dialysate to the supply line 8 of the dialysate circuit 16.

[0192] The dialysate supply line 8 also includes a respective supply pump path 8p configured to be engaged by a dialysate pump 25 of the extracorporeal blood treatment machine to facilitate flow of dialysate towards the fluid inlet of the secondary chamber 4 of the filtration unit.

[0193] The dialysate pump 25 , a peristaltic pump, defines the direction of dialysate circulation 200 and controls the flow rate of fresh dialysate from the bag 64 towards the filtration unit 2 .

[0194] In the illustrated embodiment, downstream of the dialysate pump 25 in the direction of circulation 200, a branch 56 is provided, dividing the dialysate supply line 8 into an intake branch 57 and a post-infusion path 58. In other words, the supply line 8 branches into a post-infusion path 58 that extends to the return line 7 of the blood circuit 17, so that the liquid supply line 8 is fluidly connected to the return line 7.

[0195] Infusion branch 58 makes it possible to obtain post-infusion fluid directly into blood line 17 using the contents of primary fluid container 64 .

[0196] The post-infusion pathway 58 may share an end with a third pathway 69 of the infusion line 63 such that both the infusion line 63 and the post-infusion pathway 58 are connected to one another and supply liquid to the second site 32. In particular, the post-infusion line 63 and the post-infusion pathway 58 may be connected to the bubble trap 19 of the disposable set. The shared end is located between the point where the infusion line 63 joins the post-infusion pathway 58 and the second site 32 / bubble trap 19.

[0197] In a different embodiment (not shown), the post-infusion path 58 may extend directly to the bubble trap 19 or blood return line 7 without sharing any part with the infusion line 63 .

[0198] Conversely, intake branch 57 carries fluid directly to filtration unit 2, and in particular to secondary chamber 4 of the filtration unit. Dialysate circuit 16 further includes a selector 59 for determining the ratio of fluid flow between infusion branch 58 and intake branch 57. Selector 59, typically located near branch 56, can be positioned between at least a first operating position that allows fluid to pass through intake branch 57 and blocks fluid flow through post-infusion line 58, and a second operating position that allows fluid to pass through post-infusion line 58 and blocks fluid flow through intake branch 57. In other words, selector 59 can consist of a valve element that operates on dialysate circuit 16 by alternatively blocking fluid flow through either branch. Alternatively, a suitable selector can be provided that allows a priori determination of the amount of fluid that must simultaneously pass through both branches. It is also possible to vary the proportion of fluid in either branch as a function of time and a pre-established therapy. In particular, the selector 59 may be connected to the control unit 12, the latter being configured to selectively control the selector in a first operating state and a second operating state.

[0199] The dialysate passing through the intake branch 57 enters the secondary chamber 4 of the filtration unit 2. In particular, the primary chamber 3 through which the blood flow passes is separated from the secondary chamber 4 through which the dialysate passes by a semipermeable membrane 5, ensuring the proper passage of substances / molecules and fluids from the blood to the dialysate by convection and diffusion processes, and also the passage of substances / molecules from the dialysate to the blood by diffusion.

[0200] The disposable set 100 further includes a drain line 13 connected to the liquid outlet of the filtration unit 2, and the drain line 13 may also include a respective drain pump path 13p configured to be engaged by the drain pump 26. The removed liquid is then conveyed via a drain pressure sensor 60 and a blood detector 61 into a drain, such as a collection container or bag 62.

[0201] An actuator for conveying the liquid is provided, for example a discharge pump 26 which controls the flow rate in the discharge line 13 in the liquid circuit 16, and this pump is typically a peristaltic pump.

[0202] The disposable set 100 may further include one or more pressure sensing sites 48a, 49a, 50a, 52a, 60a (see FIGS. 3-5 ) disposed on the blood circuit 17 and / or on the infusion line 63 and / or on the pre-blood pump infusion line 51 and / or on the drain line 13, allowing the pressure sensing site to sense the pressure within the respective line / circuit section. Typically, the pressure sensing sites 48a, 49a, 50a, 52a, 60a may be in the form of a POD (pressure-oscillating diaphragm) that, when connected to a respective sensor on the extracorporeal blood treatment device, allows the pressure of the tubing section in which the POD is disposed to be measured. PODs disposed on the blood circuit (or tubing section through which blood may flow) are designed to eliminate blood-air interface, thereby reducing the risk of blood clotting.

[0203] For example, pressure sensing site 48a (e.g., POD) may be disposed on blood removal line 6 between first site 31 and blood pump pathway 6p, as shown in Figures 3, 3a, 4, and 4a. An (additional) pressure sensing site 49a (e.g., POD) may be disposed on blood removal line 6 between blood pump pathway 6p and blood inlet 2a of filtration unit 2. This is shown in all of Figures 3 through 5.

[0204] Instead of (or in addition to, in embodiments not shown) pressure sensing site 48a, pressure sensing site 50a (e.g., a POD) may be located on infusion line 63 near first site 31 or at first site 31 (see FIGS. 5 and 5a). Instead of (or in addition to, in embodiments not shown) pressure sensing site 48a on blood removal line 6 or pressure sensing site 50a on infusion line 63, pressure sensing site 52a (e.g., a POD) may be located on PBP infusion line 51 (see FIGS. 3 and 3a).

[0205] The pressure sensing sites of the disposable set may themselves further include a pressure gauge, or alternatively may be configured to be connected to a pressure gauge configured to measure the pressure of the blood or fluid in the respective line.

[0206] Indeed, when each pressure site of the disposable set is appropriately connected to a pressure gauge of the extracorporeal blood treatment device, the disposable set defines a respective pressure sensor. In this regard, according to Figures 1 and 1a, a first pressure sensor 48 is defined immediately upstream of the blood pump 21, and a second pressure sensor 49 is defined downstream of the blood pump 21 and upstream of the filtration unit 2. An exhaust sensor 60 is located in the exhaust line 13 downstream of the filtration unit 2 and upstream of the exhaust pump 26.

[0207] In the embodiment of FIGS. 2 and 2 a , pressure sensor 48 is removed and an additional pressure sensor 52 is located on PBP infusion line 51 upstream of junction 51 c and downstream of PBP pump 54 .

[0208] Instead of placing the sensor on the PBP infusion line 51, the pressure sensor 50 can be placed directly on the infusion line 63, specifically just upstream of junction 51c. This latter configuration is shown in dashed lines. A control unit 12 is connected to all sensors, actuators and pumps and controls the operation of the device.

[0209] Front and rear recirculation sequence According to the present invention, the blood circuit 17 may be configured in a loop recirculation circuit 11, which may recirculate blood when, for example, an alarm is activated or when, for example, an event occurs. From a structural standpoint, in the first embodiment (e.g., FIG. 1a), the loop recirculation circuit 11 includes a supply portion of the blood removal line 6 disposed between a first site 31 of the blood removal line 6 and a blood inlet 2a of the filtration unit 2 (and including a blood pump path 6p), a blood chamber of the filtration unit 2, a receiving portion of the blood return line 7 disposed between a blood outlet 2b of the filtration unit 2 and a second site 32 of the blood return line 7, and a recirculation portion 66 of the infusion line 63 disposed between the first site 31 and the second site 32. More specifically, the recirculation portion 66 of the infusion line 63 includes a second path 68 and a third path 69 of the infusion line 63, which are connected to each other at a bifurcation site 67. The loop recirculation circuit 11 may further include a bubble trap 19 where the third pathway 69 enters the bubble trap 19 for injecting into the blood return line 7. See Figures 1a, 4a and 5a.

[0210] In a second embodiment (see, for example, FIG. 2a), the loop recirculation circuit 11 includes a supply portion of the blood removal line 6 disposed between the first site 31 of the blood removal line 6 and the blood inlet 2a of the filtration unit 2 (and including the blood pump path 6p), a blood chamber of the filtration unit 2, a receiving portion of the blood removal line 7 disposed between the blood outlet 2b of the filtration unit 2 and the second site 32 of the blood removal line 7, and a recirculation portion 66 of the infusion line 63 disposed between the first site 31 and the PBP infusion line 51. More specifically, the recirculation portion 66 of the infusion line 63 includes a second path 68 and a third path 69 of the infusion line 63, which are connected to each other at a branch site 67. Furthermore, the loop recirculation circuit 11 includes a common path of the PBP infusion line 51 between the access point 51c and the second end 51b of the PBP infusion line 51. The loop recirculation circuit 11 may further include a bubble trap 19 where the third path 69 enters the bubble trap 19 for infusion into the blood return line 7. See Figures 2a and 3a.

[0211] During a recirculation state, the loop recirculation circuit 11 is configured to allow blood to flow continuously within the loop recirculation circuit 11, and a blood pump 21 engaged with the blood pump path 6p is configured to determine the blood flow within the loop recirculation circuit 11. The loop recirculation circuit is shown in bold in Figures 1a, 2a and in accordance with certain embodiments of the disposable set 100 in Figures 3a, 4a and 5a.

[0212] The loop recirculation circuit 11 is configured to allow clockwise and / or counterclockwise fluid recirculation to avoid blood clots, for example, in situations where the blood pump is temporarily stopped and the patient is isolated in response to an alarm or event.

[0213] In general, blood recirculation in the loop recirculation circuit 11 can be initiated without stopping the blood pump 21. Indeed, it is sufficient for the control unit 12 to set the disposables to a configuration that allows blood pushed by the blood pump 21 to recirculate within the loop recirculation circuit 11. It may be sufficient to allow blood to flow along the third path 69 and the second path 68 of the infusion line 63. To achieve this configuration, the selector 70 is moved to the recirculation position (neutral position). No infusion of fluid through the infusion line 63 is commanded (i.e., the infusion pump 65 is stopped).

[0214] In particular, the blood pump speed may be different during the recirculation procedure relative to the blood pump speed during extracorporeal blood therapy.

[0215] As is apparent, it is not necessary to close either the safety valves 20 and 27 to achieve blood recirculation in the loop recirculation circuit 11. In fact, the safety valves 20, 27 on the blood circuit 17 may also be left open in case of a complete or partial access occlusion scenario, with the control unit 12 still controlling the blood pump 21 to determine the blood flow in the loop recirculation circuit 11 of the blood circuit 17 of the disposable set, but in addition (in case of partial occlusion), blood circulation is maintained in the blood circuit section between the second site 32 and the patient and between the patient and the first site 31. In fact, in the latter scenario, where the occlusion is not "complete / total," a small amount of blood flow "q" is taken from the catheter at the second end 6b, and the same small amount of blood flow can be returned to the second end 7b, while the recirculation flow "Q b -q) (the difference between the blood flow Qb determined by the blood pumping action and the small remaining blood flow q to and from the patient access) exists in the infusion line branches, i.e., the second and third paths 68 and 69.

[0216] Obviously, an alarm condition may trigger the need to stop the blood pump and / or close the safety valve. Alternatively, stopping the blood pump may not be necessary in scenarios where recirculation is selected by the operator (alarm response). In this case, one may optionally consider opening intercept element 70 without stopping blood pump 21 before closing safety valves 20 and / or 27.

[0217] Thus, the configuration provided allows blood to continue moving while the patient may or may not be isolated when connected to the disposable set.

[0218] To allow for recirculation of fluid / blood within the loop recirculation circuit, the disposable set should not include or implement any elements that may prevent recirculation, such as one-way valves, clamps, or selectors in the infusion line that prevent or are configured to prevent blood flow within the loop.

[0219] According to the embodiment of Figures 1, 1a, 4, 4a and 5 and 5a, the infusion line 63 is directly connected to the blood removal line 6 at the first site 31. The term "directly" specifies that the infusion line 63 has its second end 63b fixed to the blood removal line 6. Furthermore, there are no further branches in the infusion line 63 between the infusion site 31 and the branching site 67.

[0220] According to the embodiment of Figures 2, 2a, 3, and 3a, the infusion line 63 is not directly connected to the withdrawal line 6; instead, the infusion line 63 actually shares a common end with the pre-blood pump infusion line 51. The common end is therefore configured to selectively transport either a liquid solution coming from the second fluid source 10, a liquid solution coming from the infusion fluid source 64, or blood during a blood recirculation state. During a recirculation state, the safety clamps 20, 27 on the blood withdrawal line 6 and / or on the blood return line 7 are optionally closed. A default sequence can start from an alarm state in which the blood pump is stopped and the safety valve 20 or clamp on the blood return line 7 is closed. Generally, an infusion fluid source 64 (solution bag) should be available for the infusion line 63, e.g., at a replacement scale C. The sequence is very similar for all of the illustrated embodiments.

[0221] The main steps of the sequence are: control unit 12 moves selector 70 to the recirculation position (neutral position); before moving selector 70, control unit 12 checks the liquid level in bubble trap 19 and checks the access and return pressures to verify that they are suitable for moving selector 70 to the neutral position; if necessary, the blood or liquid level in bubble trap 19 is adjusted using air pump 47.

[0222] Before restarting the blood pump at the default low flow rate (which is usually different from the blood pump set during extracorporeal blood therapy, where the blood flow rate is set from the configuration menu), the control unit 12 checks the blood level in the bubble trap 19 and raises it to avoid recirculation of air bubbles.

[0223] Note that if vascular access to the patient (e.g., catheter access pathway) is obstructed, flow will be stopped and a large pressure differential may exist across the blood pump. A similar situation may occur during high flow therapy (such as ECCO2R) if safety valves 20 and / or 27 are closed.

[0224] If there is a large pressure difference across the blood pump, suddenly moving selector 70 to neutral can draw air bubbles into third path 69 of infusion line 63 (even if the liquid level in bubble trap 19 was OK before selector 70 switched). To avoid this problem, the pressure difference (access pressure vs. return pressure) should be at least partially equalized before selector 70 is moved.

[0225] Clearly, opening safety valves 20 and 27 is an easy solution if it is deemed safe given the circumstances. However, in the case of complete vascular access occlusion, it may not work. Alternatively, control unit 12 may infuse some infusate, for example, from infusate 64 via infusion line 63 and / or from dialysate source 14 via supply line 8 and post-infusion line 58, or across filtration unit 2 toward blood circuit 17, to adjust at least one of the access and return pressures to bring them into a closer range of values ​​(e.g., within a pressure difference of less than 50 or 100 mmHg). In this situation, pressure equalization is a prerequisite for moving selector 70, rather than restarting the blood pump.

[0226] During back-to-forth recirculation, the control unit 12 typically, but not necessarily, operates the blood pump in the same direction as during therapy. In particular, the control unit 12 continues to operate the blood pump while an operator intervenes to perform troubleshooting.

[0227] When the operator intends to resume treatment, the control unit 12 requests confirmation to either resume treatment or change / discard the disposable set.

[0228] Once the operator confirms that they wish to resume treatment, the control unit 12 checks the blood level in the bubble trap 19 and provides adjustments (e.g., via the air pump 47) according to the pressure level during recirculation versus the last return pressure operating point before recirculation.

[0229] The control unit 12 then switches the selector 70 to the pre-injection position (first operating position) before restarting all pumps to their respective prescription settings. The control unit 12 controls the blood pumps 21 to reach a predetermined blood flow rate.

[0230] Furthermore, the control unit 12 is configured to perform a step of rinsing the infusion line 63, in particular the second path 68 of the infusion line 63 through which the blood has been recirculated. If the pre-infusion flow rate is too low for timely rinsing (or is not present in the treatment setting, i.e., there is no pre-infusion), the control unit 12 commands a certain (higher) flow rate through the second path 68 of the infusion line 63. Furthermore, the third path 69 of the infusion line 63 is also rinsed. The control unit 12 is configured to move the selector 70 to post-infusion (second operating position) to flush blood from the third path 69.

[0231] Finally, if the circuit according to Figures 2 and 2a is used for recirculation, the PBP line should also be rinsed. If the PBP flow rate is not sufficient for rinsing, the control unit 12 is configured to set a flow rate in the PBP line sufficient for complete rinsing. Finally, the PBP flow rate for rinsing and the pre-infusion flow rate are synchronized so that the common line path is completely rinsed (e.g., without injecting excess citrate solution).

[0232] Of course, if the treatment prescription provides for a post-infusion rather than a pre-infusion, the control unit 12 switches the selector 70 to the second state (post-infusion) after the aforementioned rinsing step is completed.

Claims

1. A disposable set (100) for an extracorporeal blood treatment device (1), comprising: a filtration unit (2) having a blood inlet (2a) and a blood outlet (2b); - a blood circuit (17), a blood removal line (6) extending between a first end (6a) connected to the blood inlet (2a) of the filtration unit (2) and a second end (6b) for direct or indirect connection to a patient (P); a blood return line (7) extending between a first end (7a) connected to the blood outlet (2b) of the filtration unit (2) and a second end (7b) for direct or indirect connection to the patient; a blood circuit (17) including a blood pump path (6p) located on the blood circuit (17) and configured to engage a blood pump (21) of the extracorporeal blood treatment device to promote blood flow within the blood circuit; an infusion line (63) extending from a first end (63a) for connection to an infusion fluid source (64), at a branching site (67); a second end (63b) of the infusion line (63) in direct or indirect fluid communication with the blood removal line (6) at a first site (31), the first site (31) being disposed between the second end (6b) of the blood removal line (6) and the blood pump path (6p); and a third end (63c) of the infusion line (63) in direct or indirect fluid communication with the blood return line (7) at a second site (32), the second site (32) being disposed between the blood pump path (6p) and the second end of the blood return line (7); the injection line (63) branching towards Including, The blood circuit includes: a part of the blood removal line (6) arranged between the first site (31) of the blood removal line (6) and the blood inlet (2a) of the filtration unit (2); - said blood pump path (6p); - said filtration unit (2), a portion of the blood return line (7) located between the blood outlet (2b) of the filtration unit (2) and the second site (32) of the blood return line (7); - a recirculation section (66) of the injection line (63) located downstream of the branching site (67) and between the first site (31) and the second site (32), The loop recirculation circuit (11) is configured to allow at least the blood or liquid in the recirculation state to flow continuously within the loop circulation, disposable set (100).

2. 2. The disposable set according to claim 1, wherein the loop recirculation circuit (11) is configured to allow recirculation of liquid in a first direction from the first site (31) to the filtration unit (2) and from the filtration unit (2) to the second site (32), or in a second direction from the second site (32) to the filtration unit (2) and from the filtration unit (2) to the first site (31), - the blood inlet (2a) of the filtration unit (2) is in bidirectional fluid communication with the recirculation portion (66) of the infusion line (63) via the first site (31); - a disposable set, wherein the blood outlet (2b) of the filtration unit (2) is in bidirectional fluid communication with the recirculation part (66) of the infusion line (63) via the second site (32).

3. 3. A disposable set according to claim 1 or 2, wherein the second end (63b) of the infusion line (63) is directly connected to the blood removal line (6) at the first site (31); The first site (31) is a blood inlet fluidly connected to the withdrawal line (6) and facing the second end (6b) of the blood removal line (6); a blood outlet fluidly connected to the withdrawal line (6) and facing the first end (6a) of the blood removal line (6) and optionally facing the pump path (6p) of the blood removal line (6); an injection inlet fluidly connected to the recirculation part (66) of the injection line (63), in particular to the second end (63b) of the injection line (63); A disposable set comprising a liquid connector, particularly a three-way liquid connector.

4. 4. The disposable set according to claim 1, further comprising a blood warming disposable unit including a blood flow path having an inlet and an outlet, the blood warming disposable unit being fluidly connected to the blood circuit (17) upstream of the second site (32), in particular the inlet of the blood warming disposable unit being fluidly connected to the blood return line (7) and the outlet of the blood warming disposable unit being fluidly connected to the blood return line (7) upstream of the second site (32).

5. 5. The disposable set according to claim 1, wherein the infusion line (63) extends from the first end (63a) of the infusion line (63) for a first path (72), the first path (72) having at the branching site (67): a second passage (68) extending from said branching site (67) to said second end (63b) of said injection line (63); a third passage (69) extending from said branching site (67) to said third end (63c) of said injection line (63); branch into the recirculation portion (66) of the injection line (63) includes the second path (68) and the third path (69) of the injection line (63); the infusion line (63) includes a respective infusion pump pathway (65p) disposed in the first pathway (72) of the infusion line (63) and configured to be engaged by an infusion pump (65) of the extracorporeal blood treatment device, the infusion pump pathway (65p) being disposed between the first end (63a) of the infusion line (63) and the bifurcation site (67).

6. 6. The disposable set according to claim 1, wherein the third end (63c) of the infusion line (63) is directly connected to the blood return line (7) at the second site (32), or The disposable set includes a bubble trap (19) arranged on the return line (7) of the blood circuit (17) and configured to remove air bubbles from the blood during the extracorporeal blood treatment, the second site (32) is arranged in the bubble trap (19), the third end (63c) of the infusion line (63) is fluidly connected to the bubble trap (19), and the loop recirculation circuit (11) further includes the bubble trap (19).

7. 7. The disposable set according to claim 6, wherein the bubble trap (19) a blood inlet of the bubble trap (19), connected to the receiving part of the blood return line (7), the receiving part of the blood return line (7) being located between the outlet (2b) of the filtration unit (2) and the blood inlet of the bubble trap (19); a blood outlet of the bubble trap (19) connected to a secondary path of the blood return line (7), the secondary path of the blood return line (7) being located between the blood outlet of the bubble trap (19) and the second end (7b) of the return line (7); an auxiliary connection connected to said third end (63c) of said injection line (63); Includes a disposable set.

8. 8. The disposable set according to claim 1, further comprising a pre-blood pump infusion line (51) extending from a first end (51a) for connection to a second fluid source (10) and a second end (51b) fluidly connected to the blood removal line (6), the second end (51b) of the pre-blood pump infusion line (51) being arranged between the second end (6b) of the blood removal line (6) and the blood pump path (6p) and / or between the second end (6b) of the blood removal line (6) and the first site (31), the pre-blood pump infusion line (51) comprising a respective PBP infusion pump path (51p) configured to be engaged by a PBP infusion pump (54); The second end (63b) of the infusion line (63) is directly connected to the pre-blood pump infusion line (51), and in particular, directly downstream of a PBP infusion pump path (51p) of the pre-blood pump infusion line (51) configured to be engaged by a PBP infusion pump (54).

9. 9. The disposable set according to claim 8, wherein the infusion line (63) and the pre-blood pump infusion line (51) are connected to each other to form a common infusion path extending to the first site (31) of the blood removal line (6), and the loop recirculation circuit (11) includes the common infusion path.

10. 10. The disposable set according to any one of claims 1 to 9, wherein the filtration unit (2) comprises: a primary chamber (3) fluidly connected to the blood circuit via the blood inlet and the blood outlet of the filtration unit (2); a secondary chamber (4) fluidly connected or connectable to a fluid circuit (16), said secondary chamber (4) being configured to receive dialysate and / or remove effluent, The primary chamber (3) is separated from the secondary chamber (4) by a semipermeable membrane (5), The disposable set comprises: a drain line (13) extending between a first end for connection to a drain unit, such as a collection container (62), and a second end fluidly connected to a liquid outlet of a secondary chamber (4) of the filtration unit (2), the drain line (13) including a drain pump path (13p) configured to be engaged with a drain pump (26) of the extracorporeal blood treatment device to facilitate the flow of drain liquid from the liquid outlet of the secondary chamber (4) towards the drain unit; Optionally, the disposable set further comprises a fluid circuit (16) including a fluid supply line (8) extending between a first end for connection to a dialysate source (14) and a second end fluidly connected to a fluid inlet of a secondary chamber (4) of the filtration unit (2), the fluid supply line (8) including a supply pump path (8p) configured to be engaged with a supply pump (25) of the extracorporeal blood treatment device to promote dialysate towards the fluid inlet of the secondary chamber (4) of the filtration unit (2).

11. 11. The disposable set according to claim 10, wherein the liquid supply line (8) branches into a post-infusion path (58) extending to the return line (7) of the blood circuit (17) such that the liquid supply line (8) is selectively fluidly connectable to the return line (7), and optionally the post-infusion path (58) is connected to a bubble trap (19) disposed in the blood return line (7), and a third path (69) of the infusion line (63) and the post-infusion path (58) of the liquid supply line (8) share a common terminal line path.

12. 12. The disposable set according to any one of claims 1 to 11, further comprising at least one pressure detection site (48a, 49a) arranged on the blood removal line (6) between the first site (31) and the filtration unit (2), in particular, the at least one pressure detection site (48a, 49a) being a pressure pod.

13. 13. The disposable set according to any one of claims 1 to 12, further comprising a pressure detection site (50a) disposed on the infusion line (63) between the branching site (67) and the second end (63b) of the infusion line (63).

14. A disposable set (100) for an extracorporeal blood treatment device (1) is provided, said disposable set (100) comprising: a filtration unit (2) having a blood inlet (2a) and a blood outlet (2b); - a blood circuit (17), a blood removal line (6) extending between a first end (6a) connected to the blood inlet (2a) of the filtration unit (2) and a second end (6b) for connection to a patient (P); a blood return line (7) extending between a first end (7a) connected to the blood outlet (2b) of the filtration unit (2) and a second end (7b) for connection to the patient; a blood circuit (17) including a blood pump path (6p) located on the blood circuit (17) and configured to engage a blood pump (21) of the extracorporeal blood treatment device to promote blood flow within the blood circuit; a first end (51a) for connection to a second fluid source (10) and a pre-blood pump infusion line (51) extending from the second end (51b) fluidly connected to the blood removal line (6) between the second end (6b) of the blood removal line (6) and the blood pump path (6p); an infusion line (63) extending from a first end (63a) for connection to an infusion fluid source (64), at a branching site (67); a second end (63b) of the infusion line (63) that is directly connected to the pre-blood pump infusion line (51) and that is in fluid communication with the blood removal line (6) at a first site (31), the first site (31) being located between the second end (6b) of the blood removal line (6) and the blood pump path (6p); and a third end (63c) of the infusion line (63) in direct or indirect fluid communication with the blood return line (7) at a second site (32), the second site (32) being disposed between the blood pump path (6p) and the second end of the blood return line (7); the injection line (63) branching towards Including, the infusion line (63) and the pre-blood pump infusion line (51) are connected to each other to form a common infusion path extending to the first site (31) of the blood removal line (6); The blood circuit includes: - said filtration unit (2), - said blood pump path (6p); a part of the blood removal line (6) arranged between the first site (31) of the blood removal line (6) and the blood inlet (2a) of the filtration unit (2); a portion of the blood return line (7) located between the blood outlet (2b) of the filtration unit (2) and the second site (32) of the blood return line (7); a recirculation section (66) of the injection line (63) located downstream of the branching site (67) and between the first site (31) and the second site (32); said common injection path; designed to allow the flow of liquid in a loop recirculation circuit (11) including The loop recirculation circuit (11) is configured to allow at least the blood or liquid in the recirculation state to flow continuously within the loop circulation, disposable set (100).

15. 15. The disposable set according to claim 14, further comprising a pressure detection site (52a) arranged on the pre-blood pump infusion line (51) between a PBP pump path (51p) of the pre-blood pump infusion line (51) and the second end (51b) of the pre-blood pump infusion line (51), the pressure detection site (52a) being arranged between the PBP infusion pump path (51p) and the second end (63b) of the infusion line (63), in particular the pressure detection site (52a) being a pressure pod.

16. 1. An extracorporeal blood treatment device, comprising: one or more pumps (21, 25, 26, 54, 65, 75) including a blood pump (21); one or more intercept elements (20, 27, 59, 70); A disposable set (100), in particular according to any one of claims 1 to 15, a filtration unit (2) having a blood inlet (2a) and a blood outlet (2b); A blood circuit (17), a blood removal line (6) extending between a first end (6a) connected to the blood inlet (2a) of the filtration unit (2) and a second end (6b) for connection to a patient (P); a blood return line (7) extending between a first end (7a) connected to the blood outlet (2b) of the filtration unit (2) and a second end (7b) for connection to the patient; a blood circuit (17) including a blood pump path (6p) located on the blood circuit (17) and engaging with the blood pump (21) of the extracorporeal blood treatment device to promote blood flow within the blood circuit; an infusion line (63) extending from a first end (63a) for connection to an infusion fluid source (64), at a branching site (67); a second end (63b) of the infusion line (63) that is in direct or indirect fluid communication with the blood removal line (6) at a first site (31), the first site (31) being disposed between the second end (6b) of the blood removal line (6) and the blood pump path (6p); and a third end (63c) of the infusion line (63) in direct or indirect fluid communication with the blood return line (7) at a second site (32), the second site (32) being disposed between the blood pump path (6p) and the second end of the blood return line (7); the injection line (63) branching towards a disposable set (100) comprising: a control unit (12) configured to control said one or more pumps (21, 25, 26, 54, 65, 75) and said one or more intercept elements (20, 27, 59, 70) to define different flow circuits inside said blood circuit (17) and said infusion line (63), said control unit (12) comprising at least: a therapeutic flow circuit, in which the one or more pumps (21, 25, 26, 54, 65, 75) and the one or more intercepting elements (20, 27, 59, 70) are configured to allow blood to flow from the second end (6b) of the blood removal line (6) to the filtration unit (2) and from the filtration unit (2) to the second end (7b) of the blood return line (7); > a loop recirculation circuit (11) in which the one or more pumps (21, 25, 26, 54, 65, 75) and the one or more intercept elements (20, 27, 59, 70) are configured to allow blood or liquid to flow continuously in a loop circulation; and Including, The loop recirculation circuit (11) comprises: a portion of the blood removal line (6) disposed between the first site (31) of the blood removal line (6) and the blood inlet (2a) of the filtration unit (2); The blood pump path (6p); the filtration unit (2); a portion of the blood return line (7) disposed between the blood outlet (2b) of the filtration unit (2) and the second site (32) of the blood return line (7); a recirculation portion (66) of the infusion line (63) located downstream of a branching site (67) and between the first site (31) and the second site (32).

17. 17. The device according to claim 16, wherein the control unit (12) comprises: - defining said loop recirculation circuit (11), > defining the loop recirculation circuit (11) by commanding the one or more intercept elements (20, 27, 59, 70) to establish fluid communication between the first site (31) and the second site (32) via at least the recirculation portion (66) of the injection line (63); - controlling the blood pump (21) to determine the blood flow in the loop recirculation circuit (11) of the blood circuit (17) of the disposable set; configured to perform a recirculation procedure including In particular, said one or more intercept elements (20, 27, 59, 70) are an intercept element (70) acting on said injection line (63), a recirculation position, in which the intercept element (70) is configured to allow fluid communication between the first site (31) and the second site (32) via the recirculation portion (63) of the injection line (63); a locked position in which the intercept element (70) is configured to prevent fluid communication between the first site (31) and the second site (32) via the recirculation portion (63) of the injection line (63); and the intercept element (70) is movable between In the recirculation procedure, the control unit (12) is configured to switch the intercept element (70) to the recirculation position.

18. 18. The device according to claim 17, wherein before the recirculation procedure is initiated, the control unit (12) a. Stopping the blood pump (21); b. configured to operate the blood circuit (17) to reduce the pressure difference between portions of the blood circuit (17) on either side of the blood pump (21) before switching the intercept element (70) to the recirculation position; In particular, to reduce the pressure difference, the control unit (12) i. commanding the one or more intercepting elements (20, 27, 59, 70) to switch from a closed to an open position to switch from preventing to allowing the passage of liquid through the blood removal line (6) between the second end (6b) of the blood removal line (6) and the first site (31) and / or the blood return line (7) between the second site (32) and the second end (7b) of the blood return line (7); ii. Injecting an infusion liquid into the blood circuit (17) and adjusting the access and / or return pressures so that they are close to each other, e.g., a pressure difference of less than 100 mmHg; 10. An apparatus configured to perform at least one of the operations of

19. 19. The device according to any one of claims 16 to 18, wherein the one or more pumps (21, 25, 26, 54, 65, 75) include an infusion pump (65) operating on the infusion pump path (63p) of the infusion line, and wherein during the recirculation procedure the control unit (12) a. keeping the infusion pump (65) inactive, in particular the infusion pump (65) being an occlusion pump such as a peristaltic pump; b. Stopping the ultrafiltration of the liquid from the primary chamber (3) to the secondary chamber (4) of said filtration unit (2); c. Recirculating blood in said loop recirculation circuit (11) to prevent blood clotting; Optionally, the device is configured to operate the blood pump (21) at a speed different from the speed of the blood pump (21) during the extracorporeal blood treatment, in particular the control unit (12) is configured to operate the blood pump (21) in the same direction during the recirculation procedure as during the extracorporeal blood treatment.

20. 20. The device according to any one of claims 16 to 19, wherein at the end of the recirculation procedure, the control unit (12) a) moving an intercept element (70) acting on the injection line (63) to a locking position that allows the flow of liquid in a second path (68) extending from the branching site (67) to the second end (63b) of the injection line (63) and blocks the flow of liquid in a third path (69) extending from the branching site (67) to the third end (63c) of the injection line (63), thereby preventing fluid communication between the first site (31) and the second site (32) via the recirculation section (66); b. rinsing the blood in the second path (68) with liquid from the infusion line (63); The apparatus is configured to:

21. 21. Apparatus according to any one of claims 16 to 20, wherein the one or more intercepting elements (20, 27, 59, 70) a first safety valve (20) operating on the blood removal line (6) and arranged between the second end (6b) of the blood removal line (6) and the first site (31), the first safety valve (20) being arranged closer to the patient than the first site (31); a second safety valve (27) operating on the blood return line (7) and arranged between the second end (7b) of the blood return line (7) and the second site (32), in particular the second safety valve (27) being arranged closer to the patient than the second site (32); and The first safety valve (20) and / or the second safety valve (27) an open position allowing the passage of blood through the blood removal line (6) and the blood return line (7), respectively; a closed position in which the passage of blood through the blood removal line (6) and the blood return line (7), respectively, is prevented; It is movable between the control unit (12) is configured to maintain the first safety valve (20) and / or the second safety valve (27) in the open position during the recirculation procedure; In particular, in the case of a partial access occlusion scenario, the control unit (12) controls the blood pump (21) to determine the blood flow in the loop recirculation circuit (11) of the blood circuit (17) of the disposable set, so that blood circulation in the blood circuit between the second site (32) and the second end (7b) of the blood return line (7) and between the second end (6b) of the blood withdrawal line (6) and the first site (31) is maintained, and a blood flow "q" is taken at the second end (6b) of the blood withdrawal line (6) and returned at the second end (7b) of the blood return line (7), while a recirculation flow "Q ｂ -q" is present in the second path (68) and the third path (69).

22. 22. The device according to any one of claims 16 to 21, wherein the disposable set further comprises a blood warming disposable unit having a blood flow path with an inlet and an outlet, the blood warming disposable unit being fluidly connected to the blood circuit (17) upstream of the second site (32), in particular the inlet of the blood warming disposable unit being fluidly connected to the blood return line (7) and the outlet of the blood warming disposable unit being fluidly connected to the blood return line (7) upstream of the second site (32), During the recirculation procedure, the control unit (12) - stopping the heating of the blood warming bag or adjusting the set point temperature of the warming unit, in particular as a function of the patient's actual blood temperature or the patient's desired blood temperature, or as a default setting; - recirculating the blood contained in the blood warming bag; The apparatus is configured to:

23. 23. The device according to any one of claims 16 to 22, wherein the control unit (12) comprises: - determining the alarm status of said device; - checking whether an infusion fluid source (64) is available to said infusion line (63); - if the infusate source is available, initiating the recirculation procedure upon detection of the alarm condition, e.g., automatically; The apparatus is configured to:

24. 24. The device according to any one of claims 16 to 23, wherein at the end of the recirculation procedure, the control unit (12) - moving an intercept element (70) acting on the injection line (63) to a locking position in which it allows the flow of liquid in a third path (69) extending from the branching site (67) to the third end (63c) of the injection line (63) and blocks the flow of liquid in a second path (68) extending from the branching site (67) to the second end (63b) of the injection line (63), thereby preventing fluid communication between the first site (31) and the second site (32) via the recirculation part (66); - rinsing the blood in the third path (69) with liquid from the infusion line (63); The apparatus is configured to:

25. 25. The device according to any one of claims 16 to 24, wherein after stopping the blood pump (21) and before starting the recirculation procedure, the control unit (12) is configured to increase the blood level in the bubble trap (19), in particular to avoid recirculation of air bubbles; and / or To resume the extracorporeal blood treatment after recirculation, the control unit (12) is configured to check the blood level in the bubble trap (19) and provide adjustments, if necessary, e.g., via an air pump (47), depending on the pressure level during recirculation versus the return pressure operating point before the recirculation procedure.

26. 26. The device according to claim 16, wherein during extracorporeal blood therapy, the control unit (12) defines the therapy flow circuit and is configured to control the injection of a replacement liquid through the second end (63b) of the infusion line (63) into the blood in the blood withdrawal line (6) at the first site (31), and in particular, to control the injection of the replacement liquid through the second end (63b), the control unit (12) is configured to move an intercept element (70) acting on the infusion line (63) to an injection position, the intercept element (70) being configured to allow fluid communication between a first path (72) of the infusion line (63) upstream of the intercept element and the first site (31).

27. 1. An extracorporeal blood treatment device, comprising: one or more pumps (21, 25, 26, 54, 65, 75) including a blood pump (21); one or more intercept elements (20, 27, 59, 70); - a disposable set (100), a filtration unit (2) having a blood inlet (2a) and a blood outlet (2b); A blood circuit (17), a blood removal line (6) extending between a first end (6a) connected to the blood inlet (2a) of the filtration unit (2) and a second end (6b) for connection to a patient (P); a blood return line (7) extending between a first end (7a) connected to the blood outlet (2b) of the filtration unit (2) and a second end (7b) for connection to the patient; a blood circuit (17) including a blood pump path (6p) located on the blood circuit (17) and engaging with the blood pump (21) of the extracorporeal blood treatment device to promote blood flow within the blood circuit; a first end (51a) for connection to a second fluid source (10), and a pre-blood pump infusion line (51) extending from the second end (51b) fluidly connected to the blood removal line (6) between the second end (6b) of the blood removal line (6) and the blood pump path (6p); an infusion line (63) extending from a first end (63a) for connection to an infusion fluid source (64), at a branching site (67); a second end (63b) of the infusion line (63) that is directly connected to the pre-blood pump infusion line (51) and is in fluid communication with the blood removal line (6) at a first site (31), the first site (31) being located between the second end (6b) of the blood removal line (6) and the blood pump path (6p); and a third end (63c) of the infusion line (63) in direct or indirect fluid communication with the blood return line (7) at a second site (32), the second site (32) being disposed between the blood pump path (6p) and the second end of the blood return line (7); the injection line (63) branching towards The disposable set (100) comprising: a control unit (12) configured to control said one or more pumps (21, 25, 26, 54, 65, 75) and said one or more intercept elements (20, 27, 59, 70) to define different flow circuits inside said blood circuit (17) and said infusion line (63), said control unit (12) comprising at least: a therapeutic flow circuit, in which the one or more pumps (21, 25, 26, 54, 65, 75) and the one or more intercepting elements (20, 27, 59, 70) are configured to allow blood to flow from the second end (6b) of the blood removal line (6) to the filtration unit (2) and from the filtration unit (2) to the second end (7b) of the blood return line (7); > a loop recirculation circuit (11) in which the one or more pumps (21, 25, 26, 54, 65, 75) and the one or more intercept elements (20, 27, 59, 70) are configured to allow blood or liquid to flow continuously in a loop circulation; and Including, The infusion line (63) and the pre-blood pump infusion line (51) are connected to each other to form a common infusion path extending to the first site (31) of the blood removal line (6), and the loop recirculation circuit (11) comprises: the filtration unit (2); The blood pump path (6p); a portion of the blood removal line (6) disposed between the first site (31) of the blood removal line (6) and the blood inlet (2a) of the filtration unit (2); a portion of the blood return line (7) disposed between the blood outlet (2b) of the filtration unit (2) and the second site (32) of the blood return line (7); a recirculation portion (66) of the injection line (63) located downstream of the branching site (67) and between the first site (31) and the second site (32); the common injection path; 1. An extracorporeal blood treatment device comprising:

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