Disposable set and extracorporeal blood treatment device for preventing degassing in infusion lines - Patents.com

Abstract

A disposable set for an extracorporeal blood treatment device including a blood circuit including a filtration unit, a blood draw line including a blood pump line configured to be engaged by a blood pump, a blood return line, and an infusion line extending between a first end connected to the blood draw line upstream of the blood pump line and a second end for connecting to an infusion substance source, the blood pump line being interposed between the filtration unit and the first end of the infusion line, the disposable set further comprising a pressure damper disposed toward or at the first end of the infusion line, the pressure damper configured to prevent or reduce the amount of the access negative pressure from extending into the infusion line upstream of the pressure damper.

Description

[Technical field]

[0001] The present invention relates to a disposable set and an extracorporeal blood treatment device for preventing degassing of infusion fluids injected into an extracorporeal blood circuit. 2 This relates to extracorporeal blood treatments (treatments), such as blood removal treatments, therapeutic plasma exchange and / or hemoperfusion, in which a fluid is injected into the extracorporeal blood circuit at a junction where negative pressure (external pressure, e.g. atmospheric pressure, lower pressure) is created. [Background technology]

[0002] 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 the concentration of electrolytes in the blood (e.g., sodium, potassium, magnesium, calcium, bicarbonate, phosphate, chloride), and the regulation of the body's acid / base balance, especially through the removal of weak acids and the production of ammonium salts.

[0003] In people who have lost kidney function, these excretory and regulatory mechanisms fail, leading to the accumulation of water and metabolic waste products in the body and an excess of metabolic products. To overcome renal dysfunction, traditionally blood treatment involves extracorporeal circulation in a blood circuit through an exchanger with a semipermeable membrane (dialyzer) through which the patient's blood is circulated on one side of the membrane and a dialysate containing the blood's main electrolytes in concentrations close to those in the blood of healthy subjects. The patient is connected to the extracorporeal blood circuit via a draw (or arterial) line and a return (or venous) line, the latter having respective needles at the ends.

[0004] A pressure difference is created between two compartments of the dialyzer separated by a semipermeable membrane, as a result of which part of the plasma fluid passes through the membrane by ultrafiltration into the compartment containing the dialysate. The blood processing carried out in the dialyzer with regard to waste products from metabolism and electrolytes results from two mechanisms of molecular transport through the membrane between the blood and the dialysate.

[0005] The dialysate is prepared upstream of the dialyzer by mixing pure water with a number of predefined substances, such as electrolytes and buffers, which are exchanged with the patient's blood in the dialyzer. The water is obtained from an online port that receives tap water that has been purified and deionized (e.g., by reverse osmosis) and then further filtered within the machine, thereby providing a nearly limitless source of water to the blood treatment device for subsequent mixing with the concentrate. Alternatively, the dialysate is pre-prepared and stored in respective bags for delivery to the dialysis machine, as in acute dialysis treatments.

[0006] Hemofiltration or Hemodiafiltration Treatment or Blood Oxygenation / CO 2 The treatment device configured to perform the removal treatment generally comprises an infusion line connected to the blood circuit of the disposable set, which may be used to inject a substitution fluid into the patient's extracorporeal blood and / or to inject one or more specific substances to control other blood parameters. For example, a bicarbonate solution may be infused into the blood circuit to control the patient's blood acid-base balance during dialysis treatment, and a bag containing the bicarbonate solution is usually provided to be connected to the blood circuit to allow controlled infusion. Furthermore, to avoid blood clotting, an anticoagulant solution such as citrate may be infused into the blood circuit, and a bag containing citrate or other local anticoagulant is usually provided to be connected to the blood circuit to allow controlled infusion.

[0007] Currently, infusion of certain substances is provided on the collection blood line upstream of the blood pump. For example, a citrate solution is usually infused upstream of the blood pump in order to achieve a local anticoagulant effect in the blood circuit as soon as possible. During dialysis treatment, the blood pump generates a blood flow in the blood circuit, for example a peristaltic pump conveys a fluid by alternately squeezing and releasing the flexible tube of the pump, thereby moving the blood along a forward direction. A pressure regime is defined inside the blood circuit, with (usually) a negative pressure occurring upstream of the blood pump and a positive pressure occurring downstream of the blood pump. Of course, the circuit pressure in the blood line is the result of several factors, including (but not limited to) the blood pump pumping the fluid, the circuit pressure drop, and the pressure conditions at the end of the line. Blood is taken from the patient's access through the collection line, and the blood pump generates a blood flow that contributes to determine (usually) a positive pressure regime downstream of the pump, i.e., prevalence, and a negative pressure regime upstream of the pump. Negative pressure, i.e., pressure lower than atmospheric pressure, may occur in the infusion line of a pre-blood pump (PBP) that has an injection point into the blood sampling line upstream of the blood pump. Such negative pressure may cause or promote the generation of gas pre-dissolved in the fluid, i.e., bubbles. Solutions for PBP (pre-blood pump) infusion, more specifically (but not exclusively), for example, solutions containing bicarbonate administered during CRRT treatment, are degassed when injected under negative pressure. Degassing may also be visually observed in the blood set along the PBP infusion line from the outlet of the PBP pump to the PBP access interface connector.

[0008] Degassing of the solution along the PBP circuit from the outlet of the PBP pump to the site of PBP solution infusion is the source of much frustration, requiring regular monitoring and adjustment, addressing both the simple presence of air bubbles in the circuit (e.g., suspected leaks) and / or the accumulation of air and / or bubbles in the degassing chamber.

[0009] It is noteworthy that when the infusion fluid is exposed to the low pressure generated upstream of the blood pump, it is highly susceptible to gas generation, called degassing. A degassing chamber located downstream of the blood pump may be provided to capture the air bubbles, thereby reducing the health risk to the patient. In any case, the degassing chamber is not effective in preventing the cause of the fluid degassing process. Furthermore, the greater the amount of air bubbles in the blood circuit, the greater the time frequency required to periodically check the degassing chamber. When the accumulation of bubbles in the degassing chamber is in an excessive amount, it can lead to various failures (including loss of circuit and inability to return blood). Furthermore, assuming any activation of blood at the blood-air interface, the clotting risk increases.

[0010] It is therefore an object of the present invention to at least partially address one or more of the above mentioned disadvantages.

[0011] A first objective is to provide a disposable set and device for reducing or preventing degassing of an infusion fluid as it is infused into a blood line upstream of a blood pump in an extracorporeal blood treatment device.

[0012] A further objective is to increase the level of safety for the patient's health and reduce the risk of embolism and / or blood clotting.

[0013] A further object is to reduce the workload of medical personnel when servicing the degassing chamber in order to reduce the required intervention.

[0014] The objective is to increase the reliability of the automatic level control in the chamber and also reduce field problems and complaints related to degassing of solutions.

[0015] A further object is to provide a device for preventing outgassing of the infusion fluid while at the same time keeping the manufacturing costs of the device low.

[0016] According to the present invention, at least one of the above objects is achieved.

[0017] These objects and more, which will become more apparent from the following description, are substantially achieved by a disposable set and device according to one or more of the following claims and / or aspects. Summary of the Invention

[0018] The first aspect is a disposable set for an extracorporeal blood treatment device (1), said disposable set (100) comprising: a filtration unit (2), a blood circuit (17), a blood sampling line (6) extending between a first end (6a) connected to the filtration unit (2) and a second end (6b); a blood return line (7) extending between a first end (7a) connected to the filtration unit (2) and a second end (7b); A blood circuit (17) comprising: the blood circuit (17), in particular the blood draw line (6), comprises a blood pump passage (6p) configured to be engaged by a blood pump (21) of the extracorporeal blood treatment device (1) configured to determine a blood flow, at least during an operating state, a negative access pressure is experienced upstream of the blood pump passage (6p), the blood flow in the blood circuit (17) being in a direction from the blood draw line (6) towards the filtration unit (2) and from the filtration unit (2) through the blood return line (7), an infusion line (51) connected to the blood circuit (17) at a fluid access, in particular upstream of the blood pump line (6p) and extending between a first end (51a) connected to the blood draw line (6) and a second end (51b) for connection to an infusion substance source (10), the blood pump line (6p) being interposed between the second end (7b) of the blood return line (7), in particular the filtration unit (2), and the first end of the infusion line (51); The disposable set further comprises a pressure damper (40) disposed adjacent to or at the first end of the infusion line (51), the pressure damper (40) configured to prevent or reduce the amount of the negative access pressure extending within the infusion line (51) upstream of the pressure damper (40).

[0019] According to the previous aspect, the disposable set further comprises a post-infusion line (69) extending in fluid access between a first end connected to the blood circuit (17), in particular to the blood return line (7) downstream of the blood pump line (6p), and a second end (63) for connection to an infusion substance source (64), the blood pump line (6p) being interposed between the second end (7b) of the blood return line (7), in particular to the filtration unit (2), and the first end of the post-infusion line (69). In this case, the disposable set may comprise an additional pressure damper arranged close to or at the first end of the post-infusion line (69), the additional pressure damper being configured to prevent or reduce the amount of negative return pressure extending in the post-infusion line (69) upstream of the additional pressure damper.

[0020] The additional pressure damper downstream of the blood pump may be in accordance with any of the subsequent aspects detailing the pressure damper (40).

[0021] Another independent aspect is a disposable set for an extracorporeal blood treatment device (1), said disposable set (100) comprising: a filtration unit (2), a blood circuit (17), a blood sampling line (6) extending between a first end (6a) connected to the filtration unit (2) and a second end (6b); a blood return line (7) extending between a first end (7a) connected to the filtration unit (2) and a second end (7b); A blood circuit (17) comprising: the blood circuit (17), in particular the blood draw line (6), comprises a blood pump passage (6p) configured to be engaged by a blood pump (21) of the extracorporeal blood treatment device (1) configured to determine a blood flow, at least during an operating state, a negative return pressure is experienced downstream of the filtration unit (2), the blood flow in the blood circuit (17) being in a direction from the blood draw line (6) towards the filtration unit (2) and from the filtration unit (2) through the blood return line (7); a post-infusion line (69) extending between a first end connected to the blood circuit (17) at a fluid access, in particular connected to a blood return line (7) downstream of the blood pump line (6p), and a second end (63) for connection to an infusion substance source (64), the blood pump line (6p) being interposed between the second end (7b) of the blood return line (7), in particular the filtration unit (2), and the first end of the post-infusion line (69), The disposable set further comprises a pressure damper (40) disposed adjacent to or at the first end of the post-infusion line (69), the pressure damper (40) being configured to prevent or reduce the amount of negative back pressure extending within the post-infusion line (69) upstream of the pressure damper (40).

[0022] In an embodiment according to any of the preceding embodiments, the second end (6b) of the blood sampling line (6) and the second end (7b) of the blood return line (7) are - is intended for connection to a patient, or ● For / to be connected to blood ducts (306, 307) of a further extracorporeal blood circuit (such as an extracorporeal membrane oxygenation (ECMO) circuit (300)).

[0023] In a second aspect according to any of the preceding aspects, the pressure damper (40) comprises a flow path restrictor (41); the flow path restrictor (41) has a damper passage cross-section configured to allow the injection fluid to pass therethrough; - said injection lines (51) have a respective fluid passage cross-section, in particular a mean fluid passage cross-section, configured to allow said injection fluid to pass therethrough; The damper passage cross section is smaller than the fluid passage cross section, optionally the damper passage cross section is at least 50% smaller, in particular at least 80% smaller, more in particular at least 90% smaller than the fluid passage cross section.

[0024] The pressure damper (40) comprises a one-way valve (46) configured to allow fluid passage from the infusion line (51) to the blood circuit (17), in particular only in an injection direction directed towards the collection line (17), and configured to move between an open position, in which the fluid passage is permitted in the injection direction, and a closed position, in which the fluid passage is prevented in both directions, in particular fluid passage in the direction from the collection line (6) to the infusion line (51) being prevented in both states.

[0025] In a fourth aspect according to the third aspect, the one-way valve (46) is preset to an opening pressure threshold to switch between the closed position and the open position, or vice versa.

[0026] In a fifth aspect according to the third aspect, the one-way valve (46) is preset to an opening pressure threshold for switching between the closed position and the open position, and vice versa, such that - the one-way valve (46) is configured to switch to or maintain the open position when a pressure difference between the upstream and downstream sections of the one-way valve (46) is equal to or greater than the opening pressure threshold; In particular, said pressure difference is defined between a high pressure zone upstream of said one-way valve (46) and a low pressure zone downstream of said one-way valve (46) according to said injection direction, in particular said high pressure being higher than said low pressure; and, When the pressure difference is less than the opening pressure threshold, the one-way valve (46) is configured to switch to or remain in the closed position.

[0027] In a sixth aspect according to any one of the preceding aspects 3 to 5, the pressure damper (40) comprises the one-way valve (46), the preset opening pressure threshold of the one-way valve (46) corresponding to a differential pressure value higher than zero mmHg, in particular higher than 160 mmHg, in particular between 160 and 500 mmHg, in particular between 190 and 450 mmHg, more in particular between 200 and 400 mmHg, more particularly between 240 and 350 mmHg.

[0028] In a sixth embodiment according to the two preceding embodiments, the opening pressure threshold of the one-way valve (46) is set to about the maximum negative pressure allowed in the fluid access during standard operating conditions of the extracorporeal blood treatment device (1), with "about" intended to be within + / - 100 mmHg, in particular within + / - 50 mmHg.

[0029] In a sixth third aspect according to the preceding aspect, the maximum allowable negative pressure is defined as the difference between atmospheric pressure and the minimum pressure reached in the blood line at the fluid access of the infusion line (51) during standard operating conditions of the extracorporeal blood treatment device (1).

[0030] In a seventh aspect according to any one of the preceding aspects from 3, the pressure damper (40) comprises the one-way valve (46), the one-way valve (46) comprising an internal diaphragm (46a) movable between the open position and the closed position, the internal diaphragm (46a) being preloaded in the closed position, the preload defining the preset opening pressure threshold, and in particular the internal diaphragm being a flexible membrane constructed of a material between PVC, silicone, rubber, etc.

[0031] In an eighth aspect according to any one of the preceding aspects from 3, the one-way valve (46) is arranged on the infusion line (51) at a distance not greater than 6 cm, optionally not greater than 3 cm, in particular comprised between 0.1 cm and 6 cm, more in particular between 0.2 and 3 cm, from the first end of the infusion line (51).

[0032] In a ninth aspect according to any one of the preceding aspects from 3, the disposable set comprises a luer lock connector (47) housing the one-way valve (46), and in particular, the internal diaphragm (46a) is within an internal fluid passage of the luer lock connector.

[0033] In a ninth aspect of the second aspect according to any one of the preceding aspects from 3, the one-way valve is in the closed position when the differential pressure is below the preset opening pressure threshold.

[0034] In a tenth aspect according to aspect 2, the pressure damper is configured to determine a local pressure drop along a fluid passage extension of the pressure damper in a state where a fluid flows through the pressure damper, In particular, the local pressure drop is (preferably much) higher than the pressure drop defined by the injection line (51) along the same length of the fluid passage extension of the pressure damper (40).

[0035] In a tenth aspect according to aspect 2, the pressure damper (40) is the flow path restrictor (41), the damper passage extends for a length of 30 mm to 200 mm, in particular 40 mm to 160 mm, more in particular 55 mm to 150 mm, The cross section of the damper passage extends over a diameter of 0.3 mm to 0.6 mm, in particular 0.35 mm to 0.55 mm. In an eleventh aspect according to any one of the preceding aspects 2 and 10, - when the damper passage cross-section has a diameter approximately equal to 0.5 mm, the damper passage extends for a length approximately equal to 145 mm, optionally ±15 mm; and / or - when said damper passage cross-section has a diameter approximately equal to 0.4 mm, said damper passage extends for a length approximately equal to 60 mm, optionally ±10 mm; In particular, the diameter is substantially constant over the length.

[0036] In a twelfth aspect according to any one of the preceding aspects 2 and 10-11, the flow path restrictor (41) comprises a flexible conduit, in particular the conduit is constructed from PVC, silicone, or a biocompatible flexible material.

[0037] In a thirteenth aspect according to any one of the preceding aspects 2 and 10 to 12, the flow path restrictor (41) includes a partition wall that defines the damper passage cross section, Optionally, the damper passage cross section comprises: - along the flow direction of the fluid in the injection line (51) by a damper passage length of 1 mm to 30 mm, in particular 2 mm to 20 mm, in particular 4 mm to 10 mm, - Radially, with a diameter of 0.2mm to 3mm, Extending in an axial direction, Optionally, said damper passage cross-section is substantially constant along said damper passage length.

[0038] In a fourteenth aspect according to any one of the preceding aspects, the disposable set comprises: a connector body defining an interior volume; a blood inlet and a blood outlet in fluid communication with each other and with the internal volume, the blood inlet being connected to the blood sampling line (6) facing the second end of the blood sampling line and the blood outlet being connected to the blood sampling line (6) facing the blood pump channel (6p) of the blood sampling line (6); an inlet in fluid communication with said internal volume and connected to said first end of said inlet line (51); The injection connector (48) includes

[0039] In a fifteenth embodiment according to the preceding embodiments, said injection connector is a three-way connector, in particular having two inlets and one outlet.

[0040] In a sixteenth aspect according to any one of the preceding two aspects, the pressure damper (40) is disposed within the internal volume of the connector body, optionally within the injection inlet of the injection connector, and in particular the pressure damper (40) comprises the flow path restrictor (41) or the one-way valve (46).

[0041] In a sixteenth aspect according to any one of the preceding three aspects, the infusion connector is welded or glued to the infusion line (51) and the blood line.

[0042] In a sixteenth aspect three of the preceding aspects, the infusion connector is non-movably connected to the infusion line (51) and the blood line.

[0043] In a seventeenth aspect according to any one of the preceding aspects, the infusion line (51) comprises a respective infusion pump path (51p) interposed between the first end and the second end of the infusion line (51), the infusion pump path of the infusion line (51) being configured to be engaged, at least during an operating state, by an infusion peristaltic pump configured to deliver blood flow, and a positive pressure regimen is present downstream of the infusion pump path to enable the infusion fluid to flow in a direction towards the first end of the infusion line (51) and towards the blood sampling line (6).

[0044] In an 18th aspect according to any one of the preceding aspects, the pressure damper (40) is arranged on the infusion line (51) between the infusion pump line (51p) and the blood circuit (17), in particular between the infusion pump line (51p) and the blood sampling line (6).

[0045] In a nineteenth aspect according to any one of the preceding aspects, the injection inlet of the injection connector is part of the injection line (51).

[0046] In a twentieth aspect according to any one of the preceding aspects, the infusion connector is stiffer than the infusion line (51) and / or the blood draw line (6).

[0047] In a twenty-first aspect according to any one of the preceding aspects, the infusion line (51) is welded or glued to the infusion connector, particularly at the junction.

[0048] In a 22nd aspect according to any one of the preceding aspects, the injection line (51) is connected to the injection fluid connector at a connecting portion, and the internal fluid passage is substantially constant from the injection line (51) to the injection fluid connector including the connecting portion, in particular, the connecting portion does not define a discontinuity in the internal fluid passage.

[0049] In a 23rd aspect according to any one of the preceding aspects, the injection line (51) defines an internal fluid passage having a substantially constant fluid passage cross-section up to the pressure damper (40), the pressure damper (40) defining a discontinuity in the fluid passage cross-section.

[0050] In a twenty-fourth aspect according to any one of the preceding aspects, the infusion line (51) is flexible, in particular more flexible than the infusion connector.

[0051] In a twenty-fifth aspect according to any one of the preceding aspects, the blood draw line (6) is flexible, in particular more flexible than the infusion connector.

[0052] In a twenty-sixth aspect according to any one of the preceding aspects, the blood return line (7) is flexible, in particular more flexible than the infusion connector.

[0053] In a twenty-seventh aspect according to any one of the preceding aspects, the blood sampling line (6) of the blood circuit is 3 mm 2 ~20mm 2 or has a diameter comprised between 2 mm and 5 mm.

[0054] In a 28th aspect according to any one of the preceding aspects, the injection line (51) has a fluid passage cross-section comprised between a diameter comprised between 1 mm and 4 (or 3) mm.

[0055] In a twenty-ninth aspect according to any one of the preceding aspects, the flow path restrictor (41) of the pressure damper (40) is 0.07 mm 2 ~0.28mm 2 or a diameter comprised between 0.3 mm and 0.6 mm, more particularly between 0.4 mm and 0.5 mm.

[0056] In a thirtieth aspect according to any one of the preceding aspects, the flow path restrictor (41) of the pressure damper (40) extends for a length comprised between 20 mm and 200 mm, or for a length comprised between 55 mm and 150 mm.

[0057] In a thirty-first aspect according to any one of the preceding aspects, the flow path restrictor (41) of the pressure damper (40) defines an abrupt (sharp, sharp) discontinuity in the flow of the fluid in the injection line (51).

[0058] In a thirty-second aspect according to any one of the preceding aspects, the flow path restrictor (41) or the one-way valve (46) is configured to define a pressure drop of the injection fluid during an operating state of the processing device, particularly when the injection fluid flows in the injection line (51) towards the blood collection line (6).

[0059] In a thirty-third aspect according to any one of the preceding aspects, the disposable set comprises: an outlet fluid line (13) extending between a first end connected to the outlet of the secondary chamber (4) of said filtration unit (2) and a second end for connection to a drain or collection container (62); - optionally a dialysate supply line (8) extending between a first end connected to the inlet of the secondary chamber of said filtration unit (2) and a second end for connection to a dialysis fluid source, e.g. a bag or a dialysis preparation unit; The fluid circuit further comprises:

[0060] In a thirty-fourth aspect according to any one of the preceding aspects, the dialysate supply line (8) includes a respective supply pump path configured to be engaged with a dialysis fluid pump (25), and the outlet fluid line (13) includes a respective pump path configured to be engaged with a dialysate pump (26).

[0061] In a thirty-fifth aspect according to any one of the preceding aspects, the disposable set comprises an infusion substance source (10) connected to the second end of the infusion line (51), the infusion substance source (10) including an infusion bag containing a fluid infusion solution, in particular the infusion solution including one of a substitution fluid, a saline solution, and a local anticoagulant solution, and optionally the infusion solution including one or more components of bicarbonate, acetate, lactate, citrate, and electrolytes.

[0062] In a thirty-sixth aspect according to any one of the preceding aspects, the one-way valve (46) is arranged on the injection line (51) upstream of the injection connector, in particular the one-way valve (46) is arranged close to the injection connector, in particular at a distance from the injection connector comprised between 0.1 cm and 6 cm, more in particular between 0.2 and 3 cm.

[0063] In a thirty-seventh embodiment according to any one of the preceding embodiments, the filtration unit (2) has a primary chamber (3) and a secondary chamber (4) separated by a semi-permeable membrane (5).

[0064] In a thirty-eighth aspect according to any one of the preceding aspects, the negative access pressure is a pressure below the atmospheric pressure and the positive pressure is a pressure above the atmospheric pressure.

[0065] In a thirty-ninth aspect according to any one of the preceding aspects, the flow path restrictor (41) defines an opening that fluidly connects the infusion line (51) with the blood sampling line (6), the opening having a fixed size, in particular the opening is not variable and does not change size during the operating state of the extracorporeal blood treatment device.

[0066] In a fortieth aspect according to any one of the preceding aspects, the flow path restrictor (41) is defined by a restricted portion of the injection line (51), and the restricted portion of the injection fluid is configured to be clamped by a clamp.

[0067] In a fortieth aspect according to any one of the preceding aspects, the access negative pressure is an actual blood pressure at a junction between the blood lines (6, 7) and the infusion line (51).

[0068] A forty-first aspect is an assembly, comprising: A disposable set for an extracorporeal blood treatment device, said disposable set comprising: A filtration unit (2); a blood circuit (17) comprising a blood sampling line (6) extending between a first end connected to the filtration unit (2) and a second end for connection, for example, to a patient (P) or to a further blood circuit, and a blood sampling line (7) extending between a first end connected to the filtration unit (2) and a second end for connection, for example, to the patient (P) or to the further blood circuit; the blood circuit (17), in particular the blood draw line (6), comprises a pump line configured to be engaged with a blood pump (21) of the extracorporeal blood treatment device configured to determine a blood flow, at least during an operating state, a positive pressure exists downstream of the blood pump line (6p) and a negative access pressure exists upstream of the pump line, the blood flow in the blood circuit being in a direction from the blood draw line (6) towards the filtration unit (2) and from the filtration unit (2) through the blood return line (7); an infusion line (51) extending in a fluid access to the blood circuit (17), in particular between a first end connected to the blood draw line (6) upstream of the blood pump line (6p), and a second end for connection to an infusion substance source (10), the blood pump line (6p) being interposed between the second end (7b) of the blood return line (7), in particular the filtration unit (2), and the first end of the infusion line (51); A disposable set comprising: a clamp (80) adapted to engage a portion of the infusion line (51) and reduce, without closing, its internal lumen, said clamp comprising: a handheld clamp (81) configured to receive a portion of the infusion line (51) and comprising a clamp seat having a fixed size to determine a predetermined luminal reduction of the infusion line (51); a variable clamp including a clamp seat configured to receive a portion of the infusion line (51) and having an adjuster for varying the luminal reduction of the infusion line (51); and a clamp (80) comprising at least one of: the infusion line (51) having a respective fluid passage cross-section, in particular an average fluid passage cross-section, configured to allow the infusion fluid to pass therethrough when the clamp is not active on the infusion line, the infusion line (51) having a damper passage cross-section configured to allow the infusion fluid to pass therethrough when the clamp is engaged on the infusion line and active to reduce its internal lumen; The damper passage cross-section is smaller than the fluid passage cross-section, optionally the damper passage cross-section is at least 50% smaller than the fluid passage cross-section, in particular at least 80% smaller, more in particular at least 90% smaller.

[0069] A forty-first two aspect relates to an assembly, comprising: a disposable set for an extracorporeal blood treatment device (1), the disposable set (100) comprising: A filtration unit (2); A blood circuit (17), a blood sampling line (6) extending between a first end (6a) connected to the filtration unit (2) and a second end (6b); a blood return line (7) extending between a first end (7a) connected to the filtration unit (2) and a second end (7b); A blood circuit (17) comprising: the blood circuit (17), in particular the blood draw line (6), comprises a blood pump passage (6p) configured to be engaged by a blood pump (21) of the extracorporeal blood treatment device (1) configured to determine a blood flow, at least during an operating state, a negative return pressure is experienced downstream of the filtration unit (2), the blood flow in the blood circuit (17) being in the direction from the blood draw line (6) towards the filtration unit (2) and from the filtration unit (2) through the blood return line (7); a post-infusion line (69) extending in a fluid access to the blood circuit (17), in particular between a first end connected to the blood return line (7) downstream of the blood pump line (6p), and a second end (63) for connection to an infusion substance source (64), the blood pump line (6p) being interposed between the second end (7b) of the blood return line (7), in particular the filtration unit (2), and the first end of the post-infusion line (69); A disposable set comprising: a clamp (80) configured to engage a portion of the post infusion line (69) and reduce, without closing, its internal lumen, a handheld clamp (81) configured to receive a portion of the post injection line (69) and comprising a clamp seat having a fixed size to determine a predetermined luminal reduction of the post injection line (69); a variable clamp configured to receive a portion of the post injection line (69) and comprising a clamp seat having an adjuster for varying the luminal reduction of the post injection line (69); and a clamp (80) comprising at least one of: the post-infusion lines (69) have respective fluid passage cross-sections, in particular average fluid passage cross-sections, configured to allow the post-infusion fluid to pass therethrough when the clamp is not active on the post-infusion lines; The present invention is directed to an assembly in which, when the clamp is engaged on the post injection line and active to reduce the internal lumen thereof, the post injection line (69) has a damper passage cross-section configured to allow the post injection fluid to pass therethrough, the damper passage cross-section being smaller than the fluid passage cross-section, optionally the damper passage cross-section being 50% or more smaller than the fluid passage cross-section, particularly 80% or more smaller, and more particularly 90% or more smaller than the fluid passage cross-section.

[0070] The forty-second aspect is a disposable set for an extracorporeal blood treatment device according to any one of the preceding aspects; a clamp (80) configured to engage a portion of the infusion line (51) and / or the post infusion line (69) and reduce, without closing, the internal lumen thereof; The present invention relates to an assembly comprising:

[0071] In a forty-third aspect according to the preceding aspect, the clamp comprises: a handheld clamp (81) configured to receive a portion of the infusion line (51) and equipped with a clamping seat having a fixed size for determining a predetermined luminal reduction of the infusion line (51); a variable clamp configured to receive a portion of the infusion line (51) and comprising a clamp seat having an adjuster for varying the luminal reduction of the infusion line (51); At least one of the infusion line (51) having a respective fluid passage cross-section, in particular an average fluid passage cross-section, configured to allow the infusion fluid to pass therethrough when the clamp is not active on the infusion line, the infusion line (51) having a damper passage cross-section configured to allow the infusion fluid to pass therethrough when the clamp is engaged on the infusion line and active to reduce the internal lumen thereof; In particular, the damper passage cross section is smaller than the fluid passage cross section, optionally the damper passage cross section is at least 50% smaller than the fluid passage cross section, in particular at least 80% smaller, more in particular at least 90% smaller.

[0072] The forty-fourth aspect is - the disposable set according to any one of the preceding aspects, and said blood pump (21), a control unit operatively connected to said blood pump (21) and configured to control the blood flow rate of said blood pump (21); The present invention relates to an extracorporeal blood treatment device comprising:

[0073] A forty-fifth aspect relates to the disposable set according to any one of the preceding aspects 1 to 40, or the assembly according to the preceding aspects 41 to 43; a blood pump cooperating with said blood pump channel (6p) of said blood sampling line (6), an injection pump (54) cooperating with an injection pump passage (51p) of the injection line (51), the injection pump (54) being arranged between the second end of the injection line (51) and the pressure damper (40), in particular between upstream of the pressure damper (40) and downstream of the injection substance source (10); a control unit (12) operatively connected to the blood pump (21) and the infusion pump (54), the control unit (12) being configured to control the blood pump (21) and the infusion pump (54) with corresponding blood flow and infusion flow rates; The present invention relates to an extracorporeal blood treatment device comprising:

[0074] In a forty-sixth aspect according to the preceding aspect, the control unit is configured to define a processing state; the blood flow rate is between 50 ml / min and 600 ml / min, in particular between 50 ml / min and 350 ml / min, more in particular between 100 ml / min and 300 ml / min, and / or The injection flow rate is between 200 ml / h and 4000 ml / h, in particular higher than 500 ml / h and lower than 2000 ml / h.

[0075] In a forty-seventh aspect according to any one of the preceding aspects, the pressure damper (40) comprises the one-way valve (46), and the control unit: a first state in which the infusion pump (54) is active to determine fluid flow, a positive infusion pressure exists downstream of the infusion pump, the blood pump is active to determine blood flow, a negative access pressure exists upstream of the blood pump, and a positive pressure exists downstream of the blood pump; wherein the pressure differential between the infusion positive pressure and the access negative pressure is greater than the preset opening pressure threshold of the one-way valve (46) to allow the infusion fluid to enter the blood collection line (6); a second state in which the infusion pump (54) is stopped to prevent the infusion of an infusion fluid into the blood sampling line (6) and the blood pump (21) is active to determine the blood flow in the blood circuit, in which the difference between the pressure in the infusion line (51) and the access negative pressure is lower than the preset opening pressure threshold of the one-way valve (46), so that the one-way valve (46) is closed, in particular preventing the access negative pressure from penetrating into the infusion line (51); The device is configured to define:

[0076] With respect to the one-way valve, the system is independent of the flow rate of the infusion line (specifically the pre-blood pump infusion line): the valve opening pressure is built into the design and the pressure drop across the valve is ignored.

[0077] The opening pressure is selected to be higher than the minimum access pressure (absolute value) of the specified / designed access pressure operating range.

[0078] For example, the minimum access pressure may be set at -250mmHg, so that the one-way valve (46) ideally has an opening pressure just above +250mmHg, to obtain:

[0079] P acc_min + P opening > 0 That is, the minimum access pressure plus the opening pressure of the one-way valve (46) is greater than zero.

[0080] When the injection is stopped, the one-way valve (46) closes the injection circuit pressure until the injection circuit pressure becomes equal to the sum of the access pressure and the opening pressure (P access + P opening ) is lower than the sum of the infusion circuit pressure P. Considering the circuit compliance, this occurs with a (very) short delay after the infusion pump is stopped. Then, as the access pressure falls, it closes the infusion circuit pressure P access + P openingA very small amount of fluid will flow through the valve to keep the blood pressure equal to the current access pressure + P. However, at the same time, no fluid / blood will flow "upwards" from the blood line to the infusion line. In essence, when the infusion pump is stopped and the pump is in an occluded state, the pressure upstream of the valve "records" the lowest access pressure that occurred while the infusion pump was stopped. When the infusion pump is resumed, the infusion will be at the current access pressure + P. opening returns to and increases.

[0081] Of course, since few processes operate below -200mmHg and fluid degassing is very poor at (low) negative pressures above -50mmHg, a valve having a (slightly) lower opening pressure, e.g. +200mmHg, may also be acceptable.

[0082] In more general terms, the opening pressure threshold of the one-way valve 46 may be set near the maximum negative pressure permitted for fluid access during standard operating conditions of the extracorporeal blood treatment device (1) (e.g., within + / - 100 mmHg, particularly within + / - 50 mmHg).

[0083] In a 48th aspect according to any one of the preceding aspects 44 to 47, the control unit is configured to define a process state in which the blood pump (21) is set to a flow rate comprised between 50 ml / min and 600 ml / min, in particular between 100 ml / min and 350 ml / min, more in particular between 200 ml / min and 300 ml / min.

[0084] In a forty-ninth aspect according to one of the preceding aspects from 44, during the treatment state, the access negative pressure is present in the blood sampling line (6) upstream of the blood pump path (6p), in particular upstream of the blood pump.

[0085] In a 50th aspect according to any one of the preceding aspects from 44, the infusion pump optionally comprises: - controlling the infusion pump to deliver infusion fluid to the blood sampling line (6) at a flow rate comprised between 200 ml / h and 4000 ml / h, in particular between 500 ml / h and 2000 ml / h, or - stopping the infusion fluid pump to stop delivery of the infusion fluid; The control unit is operatively connected to the control unit configured to:

[0086] In a fifty-first embodiment according to any one of the preceding embodiments from 44, the infusion pump is a positive displacement pump, such as a peristaltic pump or a finger pump, or a syringe pump (plunger acting on a syringe).

[0087] In a 52nd aspect according to one of the preceding aspects from 44, the infusion substance source (10) is an infusion bag containing the infusion fluid, and the extracorporeal blood treatment device further comprises a scale operably connected to the control unit and configured to weigh the infusion substance source (10), and the control unit is configured to emit a signal representative of the weight of the infusion bag and control the infusion flow rate by commanding the infusion pump (54) as a function of the weight signal.

[0088] In a fifty-second aspect according to any one of the preceding aspects, the infusion pump (54) is a peristaltic pump.

[0089] In a fifty-third aspect according to any one of the preceding aspects, the blood pump (21) is a peristaltic pump.

[0090] In a 54th aspect according to any one of the preceding aspects, the blood pump path (6p) is interposed between the filtration unit (2) and the first end of the infusion line (51), in particular between the blood inlet of the filtration unit (2) and the first end of the infusion line (51).

[0091] In a 55th aspect according to any one of the preceding aspects, the control unit is configured to control the device to perform one of an ultrafiltration process (UF), particularly with local anticoagulation, a hemodialysis process (HD), particularly with local anticoagulation, a hemofiltration process (HF), or a hemodiafiltration process (HDF).

[0092] In a fifty-sixth aspect according to any one of the preceding aspects 1 to 54, the control unit is 2

[0023] Controlling the device configured for removal of CO 2 The device is configured to perform a removal process.

[0093] In a fifty-seventh embodiment according to the preceding embodiment, the device comprises a CO 2 Equipped with a removal device.

[0094] In a fifty-eighth embodiment according to the preceding embodiment, the CO 2 The removal device is disposed between the blood outlet and the bubble trap in the filtration unit (2).

[0095] In a fifty-ninth aspect according to any one of the preceding aspects, the ECMO circuit comprises: a blood sampling duct (306) for connection to the vascular access of the patient, configured to receive blood from the patient; a blood return duct (307) for connection with the vascular access of the patient, configured to return blood to the patient; a blood pump (321) configured to facilitate blood flow within the ECMO circuit (300); an oxygenator (310) arranged on said blood return duct (307) and configured to supply oxygen to said blood; At least the following is provided.

[0096] In a sixtieth aspect according to the preceding aspects from fifty-nine, - when the infusion line (51) is placed on the blood collection line (6) and when the blood collection line (6) is connected to the ECMO circuit (300) upstream of the blood pump (321) of the ECMO circuit, the pressure damper (40) is located in the fluid access between the blood collection line (6) and the infusion line (51); - When the infusion line (51) is arranged on the blood return line (7) and when the blood return line (6) is connected to the ECMO circuit (300) upstream of the blood pump (321) of the ECMO circuit, the pressure damper (40) is located at the fluid access between the blood return line (7) and the infusion line (51).

[0097] In a 61st aspect according to any one of the preceding aspects from 59, the pressure damper is positioned on the return line (7) of the disposable set (400) connected to the ECMO circuit (300) where negative pressure is experienced.

[0098] In a 62nd aspect according to any one of the preceding aspects from 59, the blood sampling line (6) of the disposable set (100) is connected to the ECMO circuit (300) upstream (or optionally downstream) of the blood pump (321) of the ECMO circuit (300).

[0099] In a 63rd aspect according to any one of the preceding aspects from 59, the blood return line (7) of the disposable set (100) is connected to the ECMO circuit (300) downstream (or optionally upstream) of the blood pump (321) of the ECMO circuit (300).

[0100] In a 64th aspect according to any one of the preceding aspects from 59, the blood pump (321) of the ECMO circuit is configured to promote blood flow in the ECMO circuit in a direction from the blood sampling duct (306) toward the blood return duct (307), particularly through the oxygenator (310).

[0101] In a sixty-fifth aspect according to any one of the preceding aspects from fifty-nine, the disposable set (100) is connected to the ECMO circuit (300) by a detachable connection system.

[0102] In a 66th aspect according to any one of the preceding aspects 1 to 54, the control unit is configured to control the device to perform a therapeutic plasma exchange process.

[0103] In a 67th aspect according to any one of the preceding aspects, the pressure damper (40) comprises a one-way valve configured to allow fluid passage from the infusion line (51) to the blood circuit (17), in particular only in an infusion direction directed towards the collection line (17), the one-way valve being configured to move between an open position in which fluid passage is permitted in the infusion direction and a closed position in which fluid passage is prevented in the infusion direction and in the opposite direction, in particular fluid passage in the direction from the blood circuit (17) to the infusion line (51) is prevented, and the one-way valve (46) is a duckbill valve (75).

[0104] In a sixty-eighth aspect according to the preceding aspects, the duckbill valve (75) comprises a housing (76) defining an interior volume (76a).

[0105] In a sixty-ninth aspect according to the preceding aspect, the housing (76) comprises: an inlet connector (75a) connected or adapted to be connected to the upstream flow path of the injection line (51); an outlet connector (75b) connected or adapted to be connected to the downstream path of the infusion line (51) or to the blood circuit; a duckbill component (77) disposed within the interior volume (76a) of the housing (76) and configured to allow the injection fluid to flow from the inlet connector (75a) to the outlet connector (75b) and to prevent fluid from flowing back from the outlet connector (75b) to the inlet connector (75a).

[0106] In a seventieth aspect according to the preceding aspects, the duckbill component (77) is constructed from a flexible and / or elastic material, optionally the material being one of silicone, a silicone-based material, rubber, PVC, and latex (or an equivalent material).

[0107] In a seventieth aspect according to any one of the preceding aspects from sixty-nine, the duckbill valve (75) is positioned on the injection line (51) at a distance of not more than 6 cm, optionally not more than 3 cm, in particular comprised between 0.1 cm and 6 cm, more in particular between 0.2 and 3 cm, from the first end of the injection line (51).

[0108] In the 71st aspect according to any one of the preceding aspects from 69, the inlet connector (75a) of the duckbill valve (75) faces the injection material source (10).

[0109] In a 72nd aspect according to any one of the preceding aspects from 69, the outlet connector (75b) of the duckbill valve (75) faces the blood circuit (17), in particular faces or defines the first end (51a) of the infusion line (51).

[0110] In a 73rd aspect according to any one of the preceding aspects from 69, the outlet connector (75b) of the duckbill valve (75) is interposed between the blood circuit (17) and the inlet connector (75a) of the duckbill valve (75), particularly along the flow path of the injectate.

[0111] In a 74th aspect according to any one of the preceding aspects from 69, the duckbill component (77) is interposed between the inlet connector (75a) and the outlet connector (75b) along the flow path of the infusion fluid.

[0112] In a 75th aspect according to any one of the preceding aspects 69 to 74, the inlet connector (75a) of the duckbill valve (75) is on the opposite side of the duckbill component (77) from the outlet connector (75b) of the duckbill valve (75).

[0113] In a 76th aspect according to any one of the preceding aspects 69 to 75, the inlet connector (75a) and the outlet connector (75b) are substantially aligned (registered) along a straight line that specifically coincides with the injection fluid passage direction.

[0114] In a 77th aspect according to any one of the preceding aspects 69 to 76, the duckbill component (77) of the duckbill valve (75) has a tapered shape extending between a passage wide section (77a) for the fluid and a passage closing section (77b).

[0115] In aspect 77-2 according to any one of the preceding aspects 69-77, the duckbill element (77) has a sidewall extending within the internal volume (76a) of the chamber (76), an outer surface of the sidewall being subjected to the pressure present in the chamber (76) and an inner surface of the sidewall being subjected to the pressure present at the inlet connector (75a).

[0116] In a 78th aspect according to the preceding aspect 77, the duckbill valve (75) is configured to allow the injection fluid to flow sequentially from the inlet connector (75a), into the passage wide section (77a), then through the passage closing section (77b) of the duckbill component (77), and thereafter through the outlet connector (75b) of the duckbill valve (75).

[0117] In a 79th aspect according to any one of the preceding aspects 77 to 78, the passage wide section (77a) is connected, in particular in a fluid-tight manner, to an outlet of the inlet connector (75a) inside the internal volume (76a).

[0118] In an 80th aspect according to any one of the preceding aspects 77 to 79, the wide passage section (77a) is interposed between the passage closing section (77b) and the inlet connector (75a) of the duckbill valve (75).

[0119] In an 81st aspect according to any one of the preceding aspects from 77, the passage closing section (77b) is arranged downstream of the passage wide section relative to the (said) injection fluid direction (ID).

[0120] In an 82nd aspect according to any one of the preceding aspects from 77, the passage closing section (77b) opens into the internal volume (76a) of the housing (76), and in particular, the passage closing section (77b) is not directly connected to the outlet connector (75b).

[0121] In an 83rd aspect according to any one of the preceding aspects from 77, the passage closure section (77b) is cantilevered within the internal volume (76a) of the housing (76) of the duckbill valve (75).

[0122] In an eighty-fourth aspect according to any one of the preceding aspects from seventy-seven, the passage-closing section (77b) comprises a deformable slit, the deformable slit being an open state in which the passage-closing section (77b) of the duckbill element (77) allows the injection fluid to flow from the inlet connector (75a) towards the outlet connector (75b), in particular the open state of the slit defining the open position of the one-way valve; a closed state in which the passage closure section (77b) of the duckbill element (77) is closed, in particular preventing fluid from flowing through the duckbill element (77), in particular the closed state of the slit defining the closed position of the one-way valve; It can be transformed between.

[0123] In an 85th aspect according to any one of the preceding aspects from 77, the passage closure section (77b) is configured to move from the closed state to the open state when the pressure upstream of the duckbill component (77) is greater than the pressure downstream of the duckbill component (77), in particular, when the pressure upstream of the duckbill component (77) is at least 3% or at least 5% greater than the pressure downstream of the duckbill component (77).

[0124] In an 86th aspect according to any one of the preceding aspects from 77, the passage closing section (77b) is constructed from a flexible and / or elastic material, optionally wherein the material is one of silicone, a silicone-based material, rubber, PVC, and latex.

[0125] In an 87th aspect according to any one of the preceding aspects from 68, the housing (76) is constructed from a rigid material, optionally a flexible (plastic) material.

[0126] In an 88th embodiment according to any one of the preceding embodiments from 68, the housing (76) is at least partially transparent.

[0127] In an eighty-ninth aspect according to any one of the preceding aspects, the pressure damper (40) comprises a deformable flow path restrictor (42) including and in particular consisting of an elastically deformable material, optionally one of silicone, a silicone-based material, rubber, PVC, and latex, the deformable flow path restrictor (42) comprising: In a rest state, the deformable flow restrictor (42) is substantially closed to prevent fluid flow or is less than 1 mm 2 Less than 0.5 mm 2 Less than 0.1mm 2 Less than 0.01mm 2 a damper lumen (44) defining a damper passage cross-section for said injection fluid having a size less than In particular, in a quiescent state, the damper lumen (44) of the deformable flow restrictor (42) is substantially closed in a fluid-tight manner; in an injection state, when the lumen pressure inside the deformable flow restrictor (42) exceeds a predetermined threshold, the damper lumen (44) of the deformable flow restrictor (42) opens to allow the passage of the injection fluid; It is possible to configure it as follows.

[0128] In particular, the deformable flow restrictor 42 must prevent subatmospheric pressure that may be generated along the blood circuit 17 from reaching the infusion line section upstream of the damper. In the above-described configuration, subatmospheric pressure would tend to close the damper lumen 44, thereby preventing the transmission of such pressure.

[0129] In a 90th aspect according to the preceding aspect, the predetermined threshold for opening the damper lumen (44) is greater than 1.02 times atmospheric pressure, in particular greater than 1.05 times atmospheric pressure, in particular greater than 1.1 or 1.2 times atmospheric pressure.

[0130] In a 91st aspect according to any one of the preceding aspects 89 to 90, the predetermined threshold for opening the damper lumen (44) is greater than 0.05 bar or 0.1 bar, optionally greater than 0.2 bar or 0.3 bar, and the predetermined threshold is a relative pressure with respect to atmospheric pressure.

[0131] In a 92nd aspect according to any one of the preceding aspects from 89, the damper lumen (44) of the deformable flow path restrictor (42) extends in the flow direction for a length comprised between 5 mm and 100 mm, in particular between 10 mm and 50 mm, optionally between 10 mm and 30 mm.

[0132] In a 93rd aspect according to any one of the preceding aspects from 89, the deformable flow path restrictor (42) has a folded (collapsed) damper lumen (44) having a cross-sectional shape between a line, optionally a straight line or curve, and a dot, in the rest state.

[0133] In a 93rd aspect according to any one of the preceding aspects 89 to 92, the damper lumen (44) of the deformable flow path restrictor (42) is normally closed, in particular, the damper lumen (44) of the deformable flow path restrictor (42) is normally in the rest state.

[0134] In a 94th aspect according to any one of the preceding aspects 89 to 93, when the deformable flow path restrictor (42) has a line-shaped folded damper lumen in the rest state, in the injection state the deformable flow path restrictor (42) has a lumen cross-section having an approximately elliptical shape.

[0135] In a 95th aspect according to any one of the preceding aspects 89 to 94, when the deformable flow path restrictor (42) has a point-shaped folded damper lumen (44) in the rest state, in the injection state the deformable flow path restrictor (42) has an approximately circular lumen cross-section.

[0136] This can be obtained by using a highly deformable and elastic material.

[0137] In a 96th aspect according to any one of the preceding aspects 89 to 95, the deformable flow path restrictor (42) is a conduit, optionally a conduit of the injection line (51).

[0138] In a 96th aspect according to the preceding aspect, the conduit of the deformable flow path restrictor (42) has a flat shape, and in particular, the conduit has a cross-section perpendicular to the fluid direction having an outline of an approximately elliptical shape and / or a rectangular shape.

[0139] In a 96th aspect according to any one of the preceding aspects 96 and 96.2, the conduit extends along the injection direction (ID) for a length comprised between 5 mm and 100 mm, in particular between 10 mm and 50 mm, optionally between 10 mm and 30 mm.

[0140] In aspect 96-4 according to any one of the preceding aspects 96, 96-2, and 96-3, the conduit defines therein the damper lumen (44) of the deformable flow path restrictor (42), and the damper lumen (44) has an approximately constant cross-section.

[0141] In a 97th aspect according to any one of the preceding aspects 89 to 96, the deformable flow restrictor (42) is a conduit of the injection line (51); the wall of the deformable flow path restrictor (42) has a thickness substantially equal to the thickness of the wall of the remaining part of the injection line, in particular a thickness substantially equal to the thickness of the upstream wall of the injection line (51) located upstream of the deformable flow path restrictor (42), in particular the deformable flow path restrictor (42) defines a flat channel, at least in the rest state, and optionally the deformable flow path restrictor (42) is made of the same material as the remaining part of the injection line, or the wall of the deformable flow restrictor (42) has a thickness greater than the wall thickness of the remaining part of the injection line, in particular the thickness of the upstream wall of the injection line immediately upstream of the deformable flow restrictor (42); Optionally, the deformable flow restrictor (42) is constructed from the same material as the remainder of the infusion line, particularly one of silicone, a silicone-based material, latex, or rubber.

[0142] In a 98th aspect according to any one of the preceding aspects 89-97, the deformable flow restrictor (42) is fabricated as a single piece.

[0143] In a 99th aspect according to any one of the preceding aspects 89 to 98, the deformable flow path restrictor (42) and the injection line (51) are made as a single piece without seams.

[0144] In a 99th aspect according to any one of the preceding aspects 89 to 98, the deformable flow path restrictor (42) and the injection line (51) are combined to define a single seamless part.

[0145] In a 100th aspect according to any one of the preceding aspects 89 to 99, at least in the rest state, the lumen of the infusion line (51) upstream of the deformable flow path restrictor (42) gradually reduces in size toward the damper lumen (44) of the deformable flow path restrictor (42), defining a narrowed lumen section (43).

[0146] In a 101st aspect according to the preceding aspect, the narrowed lumen section (43) defines an angle between the section of the upstream conduit and the damper section of the deformable flow path restrictor (42) that is comprised between 10° and 45°.

[0147] In a 102nd aspect according to any one of the preceding aspects 100-101, the narrowed lumen section (43) extends along the flow direction for a length of at least 2 mm, in particular at least 5 mm, optionally between 2 mm and 20 mm.

[0148] In a 103rd aspect according to any one of the preceding aspects 100-102, the narrowed lumen section (43) extends a length along a curved or straight path.

[0149] In a 104th aspect according to any one of the preceding aspects 89 to 103, when the pressure in the injection line (51) upstream and downstream of the deformable flow path restrictor (42) is less than atmospheric pressure, the deformable flow path restrictor (42) remains in the resting state.

[0150] In a 105th aspect according to any one of the preceding aspects 89 to 104, the deformable flow path restrictor (42) is configured to switch from the rest state to the injection state when pressure in the injection line (51) is higher than atmospheric pressure.

[0151] In a 106th aspect according to any one of the preceding aspects 89 to 105, the pressure damper (40) comprises a throttle device (90) operating by thrust on the deformable flow path restrictor (42), in particular on the pipeline of the deformable flow path restrictor (42).

[0152] In a 107th aspect according to the preceding aspect, the throttle device (90) comprises: - providing a closing force contribution to keep the damper lumen (44) substantially closed in the rest state; enabling the deformable flow restrictor (42) to switch to the injection state when the pressure in the injection line upstream of the pressure damper exceeds a predetermined threshold, the predetermined threshold being in particular at least 1.1 atmospheres.

[0153] In a 108th aspect according to any one of the preceding aspects 106 to 107, the throttling device (90) is disposed around the deformable flow path restrictor (42) and exerts a compressive effect on an outer surface of the deformable flow path restrictor (42).

[0154] In a 109th aspect according to any one of the preceding aspects from 106, the throttling device (90) comprises an elastic element (91), optionally a spring such as a spiral spring or a leaf spring or a spring-like element acting with a thrust on the outer surface of the deformable flow path restrictor (42).

[0155] In a 110th embodiment according to the preceding embodiments, the elastic element (91) of the wringing device (90) is preloaded in the rest state.

[0156] In a 111th embodiment according to the preceding embodiment, the preload of the elastic element (91) is manually adjustable, for example by an operator.

[0157] In a 112th aspect according to any one of the preceding aspects 110-111, the elastic element (91) of the throttle device (90) has an adjustable thrust.

[0158] In a 113th aspect according to any one of the preceding aspects 106 to 112, the throttling device (90) comprises one or more plates (92) each acting with a thrust on the outer surface of the deformable flow path restrictor (42), in particular along a length of more than 1 cm, in particular more than 2 cm, in particular between 1 cm and 5 cm, or between 1 cm and 3 cm.

[0159] In a 114th aspect according to any one of the preceding aspects, the injection pump (54) is configured to generate a head pressure greater than a predetermined threshold to open either the one-way valve (46; 75) or the deformable flow path restrictor (42).

[0160] In a 115th aspect according to any one of the preceding aspects, the injection pump (54) is configured to generate an overpressure between upstream and downstream of the deformable flow path restrictor (42) that is greater than 0.05 bar or 0.1 bar, and optionally greater than 0.2 bar or 0.3 bar.

[0161] In a 116th aspect according to any one of the preceding aspects, the infusion pump (54) comprises an occlusion pump, in particular a peristaltic pump. [Brief description of the drawings]

[0162] Certain embodiments and aspects of the present invention are described below with reference to the accompanying drawings, which are provided by way of example only. [Figure 1] , [Diagram 2] 1 and 2 are schematic diagrams of various possible embodiments of an extracorporeal blood treatment device comprising a disposable set according to the invention. [Diagram 3] FIG. 3 is a cross-sectional view of a fluid connector housing a one-way valve according to an embodiment of a disposable set of the present invention. [Figure 4] , [Diagram 5] , [Figure 6] 4-6 are schematic diagrams of flow path restrictors according to various embodiments of the disposable set of the present invention. [Figure 7] FIG. 7 is a schematic diagram of a disposable set according to the present invention fluidly connected to an ECMO circuit (schematic). [Figure 8A] FIG. 8A is a side view of a duckbill valve according to the present invention. [Figure 8B] FIG. 8B shows the duckbill valve of FIG. 8A rotated 90 degrees about fluid axis F. [Figure 8C] FIG. 8C is a cross-sectional view of the duckbill valve of FIG. 8B. [Figure 9] FIG. 9 is a cross-sectional view along the fluid axis of a deformable flow restrictor according to the present invention in a quiescent state. [Figure 9A] FIG. 9A is a cross-sectional view of the deformable flow path restrictor of FIG. 9 taken perpendicular to the fluid passage axis, with the damper lumen defining the line folded. [Figure 9A--] FIG. 9A″ is a cross-sectional view perpendicular to the fluid passage axis of an alternative embodiment of the deformable flow path restrictor of FIG. 9, in which the damper lumen defining a dot is folded. [Figure 9B] 9B is a cross-sectional view, perpendicular to the fluid passage axis, of the infusion line upstream and / or downstream of the deformable flow restrictor of FIG. [Figure 10] FIG. 10 is a cross-sectional view along the fluid axis of a deformable flow restrictor according to the present invention in an injected state. [Figure 10A] FIG. 10A is a cross-sectional view of the deformable flow path restrictor of FIG. 10 taken perpendicular to the fluid passage axis with the damper lumen defining an elliptical shape open. [Figure 10A--] FIG. 10A″ is a cross-sectional view perpendicular to the fluid passage axis according to an alternative embodiment of the deformable flow path restrictor of FIG. 10, in which the damper lumen defining a circular shape is opened. [Figure 10B] 10B is a cross-sectional view, perpendicular to the fluid passage axis, of the infusion line upstream and / or downstream of the deformable flow restrictor of FIG. [Figure 11]FIG. 11 is a cross-sectional view along a fluid axis of a deformable flow path restrictor according to a further embodiment of the invention, in a rest state. [Figure 11A] FIG. 11A is a cross-sectional view of the deformable flow path restrictor of FIG. 11 taken perpendicular to the fluid passage axis, with the damper lumen defining the line folded. [Figure 11A--] FIG. 11A″ is a cross-sectional view perpendicular to the fluid passage axis of an alternative embodiment of the deformable flow path restrictor of FIG. 11, in which the damper lumen defining a dot is folded. [Figure 11B] 11B is a cross-sectional view, perpendicular to the fluid passage axis, of the infusion line upstream and / or downstream of the deformable flow restrictor of FIG. [Figure 12] FIG. 12 is a cross-sectional view along the fluid axis of a deformable flow restrictor according to the present invention in an injected state. [Figure 12A] FIG. 12A is a cross-sectional view of the deformable flow path restrictor of FIG. 12 taken perpendicular to the fluid passage axis with the damper lumen defining an elliptical shape open. [Figure 12A--] FIG. 12A″ is a cross-sectional view perpendicular to the fluid passage axis of an alternative embodiment of the deformable flow path restrictor of FIG. 12, in which the damper lumen defining a circular shape is open. [Figure 12B] 12B is a cross-sectional view, perpendicular to the fluid passage axis, of the infusion line upstream and / or downstream of the deformable flow restrictor of FIG. [Figure 13] FIG. 13 is a cross-sectional view along the fluid axis of a deformable flow path restrictor according to another embodiment of the invention in a rest state, where the pressure damper comprises a throttling device. [Figure 13A] FIG. 13A is a cross-sectional view of the deformable flow path restrictor of FIG. 13 taken perpendicular to the fluid passage axis, with the damper lumen defining the line folded. [Figure 13B] 13B is a cross-sectional view, perpendicular to the fluid passage axis, of the infusion line upstream and / or downstream of the deformable flow restrictor of FIG. [Figure 14]FIG. 14 shows a cross-sectional view along the fluid axis of a deformable flow restrictor according to the invention in an injected state, in which the pressure damper comprises a throttle device. [Figure 14A] FIG. 14A is a cross-sectional view perpendicular to the fluid passage axis of the deformable flow restrictor of FIG. 14 with the damper lumen, which defines an elliptical shape, open. [Figure 14B] 14B is a cross-sectional view, perpendicular to the fluid passage axis, of the infusion line upstream and / or downstream of the deformable flow restrictor of FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0163] definition In this detailed description, corresponding parts shown in the various figures are designated by the same reference numerals. The drawings may illustrate the invention by non-scale representations, and therefore the parts and components illustrated in the drawings that are relevant for the purposes of the invention may relate only to schematic representations.

[0164] The terms "upstream" and "downstream" refer to the direction of travel or trajectory of fluids configured to flow within a connector or along a fluid line or duct during normal use of the device, e.g., during extracorporeal blood processing. During normal use of the device, a blood pump pumps blood from a patient's vascular access along a blood draw line, through a filtration unit, and back to the patient along a blood return line. Infusion fluids are infused into the blood from their respective fluid sources toward the blood circuit. Dialysis fluids (if any) flow from the dialysis lines to the filtration unit and toward the effluent line. Blood flow and dialysis flow are countercurrent in the filtration unit.

[0165] In an ECMO circuit, blood direction is defined by each blood pump from the blood draw line to the blood return line.

[0166] We define "dialysis fluid" as the treatment fluid introduced into the second chamber of the filtration unit 2. The dialysis fluid may be prepared online or may be prepackaged in a sterile bag. Typically, in a CRRT device / application, not only the dialysis fluid but also the substitution fluid (possibly a local anticoagulation fluid and / or an ion reconstitution fluid) is contained in a (disposable) bag.

[0167] We define "dialysate" or "effluent" as the fluid from the outlet from the second chamber of the filtration unit 2. The dialysate or effluent is the spent dialysis fluid that contains uremic toxins removed from the blood, and may include ultrafiltrate.

[0168] We define a "local anticoagulant" as a substance that, when mixed with extracorporeal blood, substantially prevents blood clotting in the extracorporeal blood circuit and is rapidly metabolized by the patient, thus avoiding systemic anticoagulation.

[0169] We define the term "degassing" as the process by which gas dissolved in a fluid, such as an infusion fluid or blood, becomes free due to localized low pressure or warming of the fluid, which results in separation of the gas from the liquid phase of the fluid, thereby generating gas bubbles in the fluid.

[0170] We define "negative pressure" as pressure below local atmospheric pressure.

[0171] We define "positive pressure" as pressure above local atmospheric pressure.

[0172] Detailed Description Disposable set 100 Reference number 100 is directed to a disposable set for use in an extracorporeal blood treatment device, such as a hemodialysis device for performing a hemodialysis treatment (HD), an ultrafiltration device for performing an ultrafiltration treatment (UF), a hemofiltration device for performing a hemofiltration treatment (HF), or a hemodiafiltration device for performing a hemodiafiltration treatment (HDF).

[0173] Alternatively, the disposable set 100 may be instructed to perform extracorporeal blood treatments, such as therapeutic plasma exchange (TPE), which is a procedure in which the patient's blood is passed through an analyzer to filter and remove the plasma. The plasma is then replaced with a replacement fluid, such as plasma from a donor, albumin, or saline.

[0174] Alternatively, the disposable set 100 may be intended for performing extracorporeal blood treatments, such as hemoperfusion treatments for blood purification, which in particular consist of passing the patient's blood through a device, usually a column, containing sorbent particles configured to remove toxins from the blood, usually in the case of the treatment of poisoning.

[0175] Alternatively, the disposable set 100 may be used to remove CO from blood. 2 It may also be directed to performing extracorporeal blood treatment for CO removal. 2 The removal process may be carried out during the dialysis process or may be carried out separately specifically via the blood circuit.

[0176] Furthermore, the disposable set 100 may be connected to a further extracorporeal blood treatment device, such as a device for blood oxygenation, i.e. an extracorporeal membrane oxygenation ECMO treatment device.

[0177] According to the above listed medical fields, the disposable set 100, as shown diagrammatically in Fig. 1 and Fig. 2, comprises blood and fluid lines configured to be associated with respective processing devices 1, e.g., peristaltic pumps for facilitating fluid flow, as well as respective sensors and actuators for operating the circuits. A detailed description of the disposable set is now provided. In this regard, for simplicity, even though the dotted lines in Fig. 2 also encompass pumps (e.g., infusion pump 54, blood pump 21, and post-infusion pump), the pumps are not part of the disposable set 100. The syringe pump 9 and the bags 10 and 64 may or may not be part of the disposable set, depending on their configuration.

[0178] The disposable set 100 comprises at least one filtration unit 2 configured to process blood drawn from a patient. The filtration unit 2 may be a filter for performing one of the following processes: hemodialysis (HD), ultrafiltration (UF), hemofiltration (HF), hemodiafiltration (HDF). The filtration unit 2 may alternatively be an absorption unit or, in the case of hemoperfusion, a sorbent cartridge for a sorbent system.

[0179] In one embodiment, the filtration unit 2 has a primary chamber 3 and a secondary chamber 4 separated by a semipermeable membrane 5, the primary chamber 3 receiving the blood taken from the patient and the secondary chamber 4 receiving the waste products and fluids removed from the blood and discharging it through an outlet connected to an output fluid line 13. Depending on the treatment, the membranes of the filtration unit may be selected to have different properties and performances. According to a further embodiment, the secondary chamber of the filtration unit 2 further comprises, in addition to the outlet, an inlet configured to receive a fluid, i.e., dialysate, from a dialysate supply line 8.

[0180] The disposable set may include an outlet fluid line 13 connected to the outlet of the dialyzer 2, and the outlet fluid line 13 may include a respective outlet pump line configured to be engaged with a dialysate pump 26.

[0181] Similarly, if the dialyzer includes an inlet, the disposable set can include a supply line 8 configured to connect to the dialyzer inlet and deliver dialysis fluid to the dialyzer 2. The dialysate supply line 8 also includes a respective supply pump line configured to be engaged with a dialysis fluid pump 25 of the extracorporeal blood treatment device.

[0182] The blood circuit further comprises a blood sampling line 6 extending between a first end 6a connected to the filtration unit 2 and a second end for connection to a patient P. If the filtration unit 2 comprises a primary chamber and a secondary chamber, the blood sampling line 6 extends between a first end 6a connected to an inlet of the primary chamber 3 of the filtration unit 2 and a second end 6b for connection to the patient P. The blood sampling line 6 is configured to receive blood from the patient P and convey the blood from the second end 6b to the first end 6a of the blood sampling line 6 along a sampling direction 200.

[0183] The blood circuit 17 further comprises a blood return line 7 extending between a first end 7a connected to said filtration unit 2 and a second end 7b for connection to said patient P. If the filtration unit 2 comprises a primary chamber and a secondary chamber, the blood return line 7 extends between a first end 7a connected to an outlet 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 blood from the outlet of the filtration unit 2 and to carry the blood along a defined return direction from the first end to the second end of the blood return line 7.

[0184] The harvest line 6 and return line 7 may be connected to the patient's bloodstream through a vascular access, such as through a needle, catheter, or access device.

[0185] The collection line 6 and return line 7 may be made (constructed) from a flexible material, such as PVC or other plastic-based biocompatible material, and the blood lines 6, 7 may also be transparent to allow the operator to see the blood flowing through the lines.

[0186] The blood sampling line 6 of the blood circuit is 3 mm in diameter, which corresponds to an inner diameter of 2 mm to 5 mm (more common inner diameters are included in the range of 2.5 mm to 4.5 mm). 2 ~20mm 2 The fluid passage cross section may be comprised between:

[0187] The blood draw line 6 includes a pump passage 6p configured to be engaged with a blood pump 21 of an extracorporeal blood treatment device configured to generate a blood flow, the blood circulating in the blood circuit in a direction 200 from the blood draw line 6 towards the filtration unit 2. At least during the operating state of the device, a positive pressure regime is typically experienced downstream of the blood pump passage 6p and a negative access pressure regime is typically experienced upstream of the blood pump passage 6p. In particular, the negative access pressure is lower than atmospheric pressure.

[0188] In one example, the blood pump 21 may be implemented by a pump rotor element that is integrated with the dialyzer and operably connected to a magnetic field for its operation.

[0189] The blood pump line 6p may be a part of the blood sampling line 6 itself, interposed between the first end 6a and the second end 6b of the blood sampling line 6.

[0190] Therefore, the blood collection line 6 is a blood pump channel 6p extending between a first end 6a and a second end 6b; a first channel extending between the first end 6a and the blood pump channel 6p; a second passage extending between the second end 6b of the blood sampling line 6 and the blood pump passage 6p; Equipped with.

[0191] The blood pump passage 6p may be different with respect to the first and second passages of the blood draw line 6 in terms of dimensions and / or materials. In particular, the blood pump passage 6p may have an outer dimension, i.e., outer diameter, that is larger than the outer dimension, i.e., outer diameter, of the first and / or second passages of the blood draw line. Additionally or alternatively, the blood pump passage 6p may have an inner dimension, i.e., inner diameter, that defines the fluid passage of the blood pump passage 6p, that is larger than the inner dimension, i.e., inner diameter, of the first and / or second passages of the blood draw line. The blood pump passage 6p may be a different tube segment with respect to the first and second passages, and the blood pump passage 6p is engaged / coupled to the first and second passages by a bonding or welding step that is performed during the manufacturing process of the disposable set 100. Typically, the blood draw line 6 has a uniform cross-section except for the pump passage 6p, which may have a slightly larger inner cross-section, e.g., 6-8 mm.

[0192] The blood pump passage 6p may also have a stiffness / elasticity different from that of the first and second passages of the blood draw line 6. For example, the blood pump passage 6p may be more flexible or elastic than the first and second passages of the blood draw line 6. The blood pump passage 6p is made of a more flexible / elastic material relative to the material of the first and / or second passages of the blood draw line 6 in order to withstand fatigue stresses caused by the peristaltic pump 21 of the external blood processing device.

[0193] The blood circuit further comprises an infusion line 51 extending between a first end 51a connected to the blood draw line 6 upstream of the blood pump line 6p at the fluid access and a second end 51b for connection to a source of infusion substance, the blood pump line 6p being interposed between the filtration unit 2 and the first end 51a of the infusion line 51.

[0194] The blood draw line 6 and the infusion line 51 may be made of the same material, i.e. PVC, silicone, or other plastic-based material. The blood draw line 6 and the infusion line 51 may have the same geometric shape, e.g., a circular cross section with a constant inner diameter and a constant outer diameter. In particular, both the blood draw line 6 and the infusion line 51 are flexible.

[0195] Injection line 51 is 0.7 mm 2 ~20mm 2 or the fluid passage cross section may have a diameter comprised between 1 mm and 5 mm.

[0196] The infusion material source 10 connected or configured to be connected to the infusion line 51 may be an infusion bag. The bag may contain a fluid infusion solution including one among bicarbonate, acetate, lactate, citrate, substitution fluid, saline, and a local anticoagulant solution. In particular, the disposable set may comprise a bag connected to the second end 51b of the infusion line 51.

[0197] The infusion line 51 may further comprise a respective infusion pump path 51p interposed between the first end 51a and the second end 51b of the infusion line 51. The infusion pump path 51p of the infusion line 51 is configured to be engaged by the infusion pump 54, i.e. a peristaltic pump, configured to determine, at least during an operating state of the infusion pump 54, a positive pressure downstream of the infusion pump path 51p to allow the infusion fluid to flow in a direction from the second end of the infusion line 51 to the first end towards the blood draw line 6. The infusion pump path 51p may comprise the same characteristics as described above according to the blood pump path 6p of the blood draw line 6.

[0198] Thus, the injection line 51 is an injection pump passage 51p extending between a first end 51a and a second end 51b; a first passage extending between a first end of the infusion line 51 and a first end of the infusion pump 54; a second passageway extending between a second end of the infusion line 51 and a second end of the infusion pump 54; Equipped with The infusion pump passages are different from the first and second passages of the infusion line 51 in terms of dimensions and / or materials. In particular, the infusion pump passages may have outer dimensions, i.e., outer diameters, that are larger than the outer dimensions, i.e., outer diameters, of the first and / or second passages of the infusion line 51. Additionally or alternatively, the infusion pump passages may have inner dimensions, i.e., inner diameters, that define a fluid passageway, that are larger than the inner dimensions, i.e., inner diameters, of the first and / or second passages of the infusion line 51. The infusion pump passages 51p may be different tubing segments with respect to the first and second passages, and the infusion pump passages are engaged / coupled to the first and second passages by a bonding or welding step performed during the manufacturing process of the disposable set 100.

[0199] The infusion pump passage 51p may also have a different stiffness / elasticity with respect to the stiffness of the first and second passages of the infusion line 51. For example, the infusion pump passage 51p may be more flexible / elastic than the first and second passages of the infusion line 51. The infusion fluid pump passage is made of a material that is more flexible / elastic with respect to the material of the first and / or second passages of the infusion line 51 to withstand fatigue stresses caused by the peristaltic infusion pump 54 of the external blood treatment device.

[0200] The blood circuit 17 comprises an intersection where an infusion line 51 is joined to the blood draw line 6 to enable infusion fluid flowing within the infusion line 51 to be infused into the blood draw line, and in particular the intersection includes an infusion connector 48 having a connector body defining an interior volume.

[0201] The infusion connector comprises a blood inlet 48a and a blood outlet 48b in fluid communication with each other and with the internal volume of the connector, the blood inlet 48a being connected to the blood draw line 6 and facing the second end 6b of the blood draw line 6, while the blood outlet 48b being connected to the blood draw line 6 and facing the blood pump passage 6p of the blood draw line 6. In particular, blood flows through the infusion connector in a draw direction 200 from the blood inlet 48a to the blood outlet 48b of the infusion connector 48. The infusion connector 48 further comprises an infusion inlet 48c in fluid communication with the internal volume of the connector body and connected to the first end 51a of the infusion line 51. The infusion inlet 48c, the blood inlet 48a, and the blood outlet 48b are thus in fluid communication with each other and define a three-way connector having two inlets and one outlet.

[0202] The infusion connector 48 may be made of a plastic material. In particular, the infusion connector is generally stiffer than the infusion line 51 and / or the blood draw line 6. Conversely, the infusion line 51 is flexible, in particular more flexible than the infusion connector 48. Similarly, the blood draw line 6 is more flexible than the infusion connector. For example, the blood draw line 6 may be as flexible as the infusion line 51.

[0203] The infusion fluid connector 48 may be integral with the blood draw line 6 and the infusion line 51, in which case the first end of the infusion line 51 is welded or glued to the infusion inlet of the infusion connector. Also, the blood draw line 6 is welded or glued to the blood inlet and blood outlet of the infusion connector 48. The term "welded" may refer to thermal or chemical welding between the blood or infusion line 51 and the infusion connector. Thus, the infusion connector 48, the blood draw line 6, and the infusion line 51 may define an inseparable fluid line set. In particular, the disposable set including the blood draw line 6, the infusion line 51, the blood return line 7, and the dialyzer 2 may be integral, thereby defining the integral disposable set 100. In particular, detachable connectors for connecting the blood circuit to the infusion line 51 and the filtration unit 2 may not be provided in the disposable set.

[0204] In particular, the infusion fluid may be, for example, a substitution fluid or saline or a local anticoagulant fluid, depending on the particular step of the particular treatment and / or device operation sequence (e.g., priming the patient for blood treatment). The infusion fluid may include a buffer (e.g., bicarbonate, acetate, or lactate), one or more electrolytes (e.g., sodium, magnesium, calcium, potassium, etc.), or a local anticoagulant such as a citrate (e.g., trisodium citrate or citric acid).

[0205] According to one embodiment, the infusion line 51 is connected to the infusion connector 48 at a junction that defines a junction without discontinuities in the fluid pathway. In other words, a substantially constant internal fluid pathway from the infusion line 51 to the infusion connector includes the junction, and in effect, the junction does not define a discontinuity in the internal fluid pathway to avoid fluid flow disturbances.

[0206] In particular, the negative pressure regime in the blood lines of the disposable set extends at least between the blood pump path 6p of the blood collection line 6 and the intersection with the infusion line 51, and in particular, the negative pressure regime may extend at least between the blood pump path 6p of the blood collection line 6 and the second end 6b of the blood collection line 6 at the connection with the patient.

[0207] The disposable set 100 further comprises a pressure damper 40 arranged towards or at the first end of the infusion line 51. In particular, the pressure damper 40 may be arranged at the infusion connector, i.e. at the intersection between the blood draw line 6 and the infusion line 51 or on the infusion line 51 close to the intersection, i.e. at a distance from the intersection comprised between 0.1 cm and 6 cm, more in particular between 0.2 cm and 3 cm. The pressure damper 40 is arranged on the infusion line 51 between the infusion pump passage 51p and the blood draw line 6.

[0208] The pressure damper 40 is configured to prevent or reduce the amount of negative access pressure from penetrating into the infusion line 51 upstream of the pressure damper 40 relative to the direction of the infusion fluid, which is directed from the second end 51b to the first end 51a of the infusion line 51. As already mentioned, the negative access pressure may cause degassing, particularly in the infusion fluid, thereby generating air bubbles, which is problematic when present in the blood circuit for all the reasons explained above. Thus, the pressure damper 40 allows the infusion fluid in the infusion line 51 to be at a pressure higher than the negative access pressure during the operating conditions of the blood processing device, thereby reducing or preventing degassing of the infusion fluid.

[0209] To accomplish the task of reducing or preventing negative pressure in the infusion line, two different approaches are provided: in the first approach, the fluid passage in the infusion line is appropriately restricted but not prevented from flowing (i.e., the fluid flow path, although restricted, is always open regardless of the operating state of the device); in the second approach, a suitable one-way valve is used with an opening threshold to prevent the passage of fluid unless a certain pressure differential across the one-way valve exists in the infusion line.

[0210] According to a first embodiment, the pressure damper 40 may be a flow path restrictor 41 with a damper passage cross-section configured to allow the injection fluid to pass therethrough, the damper passage cross-section being smaller than the fluid passage cross-section of the injection fluid, for example the damper passage cross-section may be at least 50% smaller than the fluid passage cross-section, in particular at least 80% smaller, in particular more than 90% smaller. The flow path restrictor may define a fluid passage cross-section having a circular shape.

[0211] The flow path restrictor 41 of the pressure damper 40 may, for example, have a fluid passage with a diaphragm having a circular shape, reducing the fluid passage cross section relative to the passage cross section of the infusion line 51. In order to achieve a sufficient pressure drop in view of a typical infusion rate of about 1000 ml / h, the diaphragm should define a fluid passage with a cylindrical cross section with a diameter of less than 0.4 mm if a fluid passage length of less than 60 mm is desired. It may be difficult to mold a plastic element with an internal diameter of 0.5 mm or less, but ultimately a metal part may be used. Needles such as 33G (0.24 mm), 32G (0.26 mm), 30G (0.3 mm), 27G (0.41 mm), 26G (0.45 mm), etc. may be used. The required length of the part can be practically obtained.

[0212] The fluid passage extends axially along the flow direction of the injection line 51 with a fluid passage length comprised between 1 mm and 30 mm, in particular between 2 mm and 15 mm, in particular between 4 mm and 10 mm. According to embodiments comprising a partition, the flow path restrictor 41 of the pressure damper 40 may define an abrupt discontinuity for the fluid flow in the injection line 51.

[0213] According to an embodiment, the damper passage cross-section of the flow path restrictor 41 is substantially constant along the length of the fluid path. In particular, the flow path restrictor 41 defines an opening that places the infusion line 51 in fluid communication with the blood draw line 6. The opening is fixed in size, and effectively the size cannot be altered by the operator during processing.

[0214] According to one embodiment, the flow path restrictor of the pressure damper 40 may be located within the infusion connector, specifically within the infusion inlet 48c of the infusion connector 48.

[0215] Alternatively, the flow path restrictor of the pressure damper 40 may be arranged on the infusion line 51 upstream of the infusion connector 48, as close as possible to the blood collection line 6, with respect to the flow direction of the infusion fluid. For example, the pressure damper 40 may be a damper connector interposed between the upstream and downstream flow paths of the infusion line 51, and the flow path restrictor is arranged in the damper connector. This damper connector may extend along the infusion fluid direction by a length comprised between 5 mm and 30 mm, in particular between 10 and 20 mm. According to this embodiment, the damper connector may be made of a material that is harder than and different from the material of the infusion line 51, for example, the damper connector may be made of metal and the infusion line 51 may be made of flexible PVC or silicone.

[0216] In particular, when a passage restrictor is provided, the inlet line 51 defines an internal fluid passage having a substantially constant fluid passage cross-section up to the passage restrictor of the pressure damper 40, and the passage restrictor therefore defines a discontinuity in the fluid passage cross-section to prevent negative pressure from extending into the inlet line 51.

[0217] Indeed, the flow path restrictor 41 is configured to define a pressure drop of the infusion fluid during operating conditions of the processor, in particular when the infusion fluid flows in the infusion line 51 towards the blood draw line 6. The pressure drop is considered as the pressure difference between the infusion line and the blood draw line upstream of the blood pump path, in particular the pressure drop is considered as the pressure difference between the section immediately upstream of the pressure damper 40 and the section immediately downstream of the pressure damper 40.

[0218] 4 shows a further embodiment in which the flow path restrictor 41 comprises a conduit defining a first end of the injection line. The conduit has an inner diameter smaller than the inner diameter of the injection line and extends a greater length than the flow path restrictor described in the previous embodiment. In particular, the damper passage of the conduit extends a length comprised between 30 mm and 200 mm, in particular between 40 mm and 160 mm, more in particular between 55 mm and 150 mm, and the damper passage cross section extends with a diameter comprised between 0.3 mm and 0.6 mm, in particular between 0.35 mm and 0.55 mm.

[0219] More specifically, according to a particular embodiment, if the damper passage cross-section has a diameter approximately equal to 0.5 mm, the damper passage extends a length approximately equal to 145 mm, optionally by ±15 mm, while if the damper passage cross-section has a diameter approximately equal to 0.4 mm, the damper passage extends a length approximately equal to 60 mm, optionally by ±10 mm. The diameter of the damper passage is approximately constant over the length.

[0220] In particular, the conduit defining flow path restrictor 41 may be made from the same material as the rest of the infusion line, ie, a flexible material such as medical grade PVC, silicone, or another biocompatible material.

[0221] To avoid degassing of the injection fluid, the inner diameter of the flow path restrictor 41 depends on the length of the flow path restrictor 41 and vice versa. Indeed, taking into account the properties of the injection fluid and the flow rate set for it, the pressure drop across the pressure damper is defined by the damper passage cross section and by the length of the flow path restrictor 41. In particular, the damper passage cross section is proportional to the length of the flow path restrictor 41. In other words, the smaller the damper passage cross section, the shorter the length of the flow path restrictor 41 is required to obtain a sufficient pressure drop to avoid degassing of the injection fluid in the injection line 51.

[0222] According to yet another embodiment, the flow path restrictor 41 may be defined by a clamp 80 configured to clamp the infusion line 51 and deform the infusion line, so that the internal lumen is reduced (but not completely closed as in a normal clamp). The clamp thus acts on the outer surface of the infusion line 51, radially compressing the line and reducing the internal damper passage cross section. The clamp 80 may comprise a handheld clamp 81, as shown diagrammatically in FIG. 5, configured to receive a portion of the infusion line 51 and comprising a clamp seat having a fixed size to determine a predetermined lumen reduction of the infusion line 51 along a certain tube length. This type of clamp is designed according to the specific geometry, i.e. size, of the infusion line in order to cause a predetermined lumen restriction. In this embodiment too, there is a relationship between the lumen restriction and the length of the tube section that is restricted. The longer the tube section that is restricted, the smaller the lumen restriction and vice versa.

[0223] Alternatively, clamp 80 may comprise a variable clamp 82 comprising a clamp seat configured to receive a portion of infusion line 51 and an adjuster for varying the luminal reduction of infusion line 51, as shown in FIG. 6 .

[0224] In particular, the flow path restrictor 41 defined by the clamp 80 is defined by the same geometric characteristics as already described according to the previous embodiment, in particular with regard to the damper passage cross-section of the flow path restrictor 41 and its length. In other words, the clamp has a predetermined length and is designed to determine the damper passage cross-section of the flow path restrictor 41 in order to reduce or avoid degassing of the injected fluid.

[0225] According to another embodiment, as shown in Fig. 3, the pressure damper 40 may comprise a one-way valve 46 configured to allow fluid passage only along the injection direction from the injection line 51 towards the blood draw line. The one-way valve 46 is configured to move between an open position, in which fluid passage is permitted in the injection direction, and a closed position, in which fluid passage is prevented in the injection direction, in particular in both directions. In particular, the one-way valve allows fluid to flow only in one direction, i.e. the injection direction, while fluid flow in the opposite direction is always prevented.

[0226] The one-way valve 46 may be preset to an opening pressure threshold for switching between an open position and a closed position, or vice versa, such that if the differential pressure between the upstream and downstream sections of the one-way valve 46 is equal to or greater than this opening pressure threshold, the one-way valve 46 is configured to switch to or maintain the open position. Alternatively, if the differential pressure is lower than this opening pressure threshold, the one-way valve 46 is configured to switch to or maintain the closed position. In particular, the opening pressure is defined as the differential pressure between the sections immediately upstream and immediately downstream of the one-way valve, or in other words, the upstream and downstream pressures are the local pressures around the inner membrane of the one-way valve.

[0227] In particular, a differential pressure is defined between a high pressure in the upstream section of the one-way valve 46 and a low pressure in the downstream section of the one-way valve 46, the high pressure being higher than the low pressure. In particular, the high pressure is the pressure in the infusion line 51 upstream relative to the one-way valve, relative to the infusion direction, while the low pressure is the access negative pressure proximal to the catheter / vascular access. The pre-set opening pressure threshold of the one-way valve 46 corresponds to a differential pressure value comprised between 160 and 500 mmHg, in particular between 190 and 450 mmHg, more particularly between 200 and 400 mmHg, more particularly between 240 and 350 mmHg. These pressure ranges correspond to pressure regimes that are usually elevated when normal blood and infusion flows are generated in the disposable set. It is clear that the opening threshold of the one-way valve may be configured for the most common operating state of the device or may be optimal for any operating state of the device, as discussed above.

[0228] The one-way valve 46 may include an internal diaphragm 46a movable between an open position and a closed position. The internal diaphragm may be a flexible membrane made of a material such as silicone, rubber, PVC, or the like. The internal diaphragm is preloaded in the closed position to define a preset opening pressure threshold. In particular, the internal diaphragm may have a hemispherical shape such that a central portion of the internal diaphragm is axially shifted relative to an external contour. The geometric characteristics of the internal diaphragm and its material define the preload and therefore the preset opening pressure threshold.

[0229] According to an embodiment, the disposable set comprises a luer lock connector 47 housing a one-way valve 46, the internal diaphragm being within the internal fluid passage of the luer lock connector. The luer lock connector may be arranged on the infusion line 51, i.e. towards the first end 51a of the infusion line 51, for example at a distance comprised between 0.1 cm and 6 cm, more particularly between 0.2 and 3 cm from the first end of the infusion line 51.

[0230] Alternatively, the one-way valve 46 may be disposed within the injection connector 48, specifically within the injection inlet 48c of the injection connector 48.

[0231] In the following, a pressure damper 40 with a one-way valve according to the embodiment shown in Figures 8A and 8B and in cross-section in Figure 8C is described. The one-way valve in Figure 8B is rotated 90° relative to Figure 8A about a fluid axis F. The one-way valve is configured to allow fluid passage only in an injection direction ID from the injection line 51 towards the blood circuit 17, e.g. towards the withdrawal line 17. The one-way valve may be configured to move between an open position, in which fluid passage is permitted in the injection direction, and a closed position, in which fluid passage is prevented in the injection direction as well as in the opposite direction. The opposite direction is defined as the direction from the blood circuit 17 towards the injectate source 10. In other words, when the one-way valve is in the closed position, the pressure damper 40 defines a fluid-tight seal in both directions.

[0232] The particular embodiment of Figures 8A, 8B, and 8C is directed to a duckbill valve 75 that acts as a one-way valve as described above.

[0233] The duckbill valve 75 may include a housing 76 that defines an interior volume 76a, and the housing 76 may be made from a rigid material such as metal or plastic or glass. The material may be selected from materials that are compatible with the infusion fluid and the extracorporeal blood treatment device. The housing 76 may be made from a transparent material to allow visualization of the interior volume 76a.

[0234] The housing 76 may have a cylindrical shape extending with a length comprised between 2 cm and 10 cm and a diameter comprised between 1 cm and 5 cm, in particular between 1 cm and 3 cm. The housing 76 may alternatively have other shapes, such as a polygonal cross section.

[0235] The housing 76 may include an inlet connector 75a connected or configured to be connected to the upstream flow path of the injection line 51. The inlet connector 75a is configured to receive injection fluid from the substance source 10. Thus, the upstream flow path of the injection line 51 is interposed between the duckbill valve 75 and the injection substance source 10. In other words, the inlet connector 75a of the duckbill valve 75 faces the injection substance source 10.

[0236] Inlet connector 75a preferably has a cylindrical shape to facilitate engagement with the upstream flow path or conduit of infusion line 51. Inlet connector 75a may optionally comprise a luer lock connector.

[0237] The housing 76 may also comprise an outlet connector 75b connected or configured to be connected to a downstream flow path of the infusion line 51. The outlet connector 75b is configured to allow the infusion fluid to flow out of the interior volume 76a of the duckbill valve 75 in a direction towards the blood circuit. Thus, the downstream flow path of the infusion line 51 is interposed between the duckbill valve 75 and the blood circuit 17. The outlet connector 75b preferably has a cylindrical shape to facilitate engagement with the upstream flow path, i.e., the tubing, of the infusion line 51. The outlet connector 75b may optionally comprise a luer lock connector.

[0238] The outlet connector 75 b of the duckbill valve 75 faces the blood circuit 17 , in particular the first end 51 a of the infusion line 51 .

[0239] Housing 76 may further comprise a duckbill component 77 disposed within interior volume 76a of housing 76 and configured to selectively define open and closed positions of the aforementioned one-way valve. More specifically, duckbill component 77 allows injection fluid to flow from inlet connector 75a to outlet connector 75b and prevents fluid from flowing back from outlet connector 75b to inlet connector 75a.

[0240] In particular, duckbill component 77 is inside interior volume 76a of housing 76 and is preferably interposed between inlet connector 75a and outlet connector 75b along the fluid path of the infusion fluid. In particular, inlet connector 75a and outlet connector 75b may be generally aligned along a line that coincides with the infusion fluid passage direction, i.e., a straight line, and duckbill component 77 may be aligned along said line such that inlet connector 75a, outlet connector 75b and duckbill component 77 are aligned along a straight line. Preferably, inlet connector 75a of duckbill valve 75 is on the opposite side to duckbill component 77 from outlet connector 75b of duckbill valve 75.

[0241] The duckbill component 77 may be made from a flexible and / or resilient material, which may be one of silicone, a silicone-based material, rubber, and latex.

[0242] The duckbill component 77 of the duckbill valve 75 may have a tapered shape, with the tapered portion facing the outlet connector 75b. The tapered duckbill component 77 may extend between a fluid passage wide section 77a and a passage closing section 77b, such that the injection fluid flows sequentially from the inlet connector 75a, into the passage wide section 77a, then through the passage closing section 77b of the duckbill component 77, and then through the outlet connector 75b of the duckbill valve 75.

[0243] The wide passage section 77a is fluid-tightly connected to the outlet of the inlet connector 75a in the internal volume 76a. The wide passage section 77a is thus interposed between the passage closing section 77b and the inlet connector 75a of the duckbill valve 75.

[0244] The passage closure section 77b is disposed downstream of the passage wide section 77a with respect to the injection direction ID. In particular, the passage closure section 77b opens into the internal volume 76a of the housing 76. In particular, the passage closure section 77b may not be connected to the outlet connector 75b, but may in fact be cantilevered within the internal volume 76a of the housing 76 of the duckbill valve 75.

[0245] The passageway closure section 77b may comprise a deformable slit that is deformable between an open and a closed state. In the open state, the passageway closure section 77b of the duckbill component 77 allows injection fluid to flow from the inlet connector 75a towards the outlet connector 75b, and in particular, the open state of the slit defines the open position of the one-way valve as previously described.

[0246] In the closed state, the passageway closure section 77b of the duckbill component 77 is closed, thereby preventing fluid from flowing through the duckbill component 77. In particular, the closed state of the slit defines the closed position of the one-way valve, as previously described.

[0247] Passage closure section 77b is configured to move from a closed state to an open state when the pressure upstream of duckbill component 77 is greater than the pressure downstream of duckbill component 77. In particular, duckbill component 77 can open when the pressure upstream of duckbill component 77 is at least 3% or at least 5% greater than the pressure downstream of duckbill component 77. In other words, duckbill component 77 can open when the upstream pressure in the injection line is greater than the downstream pressure by a differential pressure comprised between 0.1 bar and 1 bar.

[0248] The passageway closing section 77b, particularly the slit, may be made from a flexible and / or resilient material, such as one of silicone, a silicone-based material, rubber, and latex. The duckbill component 77 may be formed as a single piece.

[0249] An alternative embodiment of pressure damper 40 is shown in Figures 9A-14B, in which, instead of a one-way valve, pressure damper 40 includes a deformable flow path restrictor 42 made from an elastic material, such as one of silicone, a silicone-based material, rubber, PVC, and latex.

[0250] The deformable flow path restrictor 42 is configurable to a rest state, in which the deformable flow path restrictor 42 has a damper lumen 44 that is substantially closed to prevent fluid flow. The deformable flow path restrictor 42 in the rest state is shown in Figures 9, 11 and 13, and in respective cross-sectional views 9A, 9A", 11A, 11A", and 13A. Thus, in the rest state, the deformable flow path restrictor 42 defines a closure to the fluid passageway, such that fluid downstream of the pressure damper is fluidly isolated from fluid upstream of the pressure damper. In particular, in the rest state, the damper lumen 44 of the deformable flow path restrictor 42 is substantially closed in a fluid-tight manner.

[0251] Alternatively, the damper lumen 44 of the deformable flow restrictor 42 may be 1 mm 2 Less than 0.5 mm 2 Less than, more specifically, 0.1 mm 2 The damper lumen 44 of the deformable flow path restrictor 42 may define a damper passage cross-section for the infusion fluid having a size of less than 0.01 mm, more particularly less than 0.01 mm. In this alternative embodiment, the damper lumen 44 of the deformable flow path restrictor 42 defines a restriction for the fluid passage, instead of the fluid-tight closure previously described, thereby allowing the fluid to pass.

[0252] In particular, the rest state is defined when the pressure upstream of the deformable flow path restrictor 42 is approximately equal to the pressure downstream of the deformable flow path restrictor 42. Furthermore, the rest state is defined when the pressure in the deformable flow path restrictor 42 is approximately equal to atmospheric pressure. It is configured to maintain the rest state when the deformable flow path restrictor 42 is, for example, disconnected from the infusion line, i.e., the damper lumen 44 is closed or significantly reduced. In other words, the shape of the deformable flow path restrictor 42 when not subjected to external pressure / load (load), i.e., when in the rest state, is such that the damper lumen 44 is closed or significantly reduced, and the rest state is maintained by the elastic shape of the deformable flow path restrictor 42.

[0253] In particular, the deformable flow path restrictor 42 is configured to return from an injected state to a quiescent state due to its elastic properties.

[0254] 9A and 9A" show, in cross-section, two different shapes of the damper lumen 44 of the deformable flow path restrictor 42 in a resting state for illustrative purposes only. The damper lumen 44 of the flow path restrictor 42 in FIG. 9A has a straight shape, which may have originally come from a circular lumen that was folded to close the fluid passageway during manufacturing. This results in a deformable flow path restrictor 42 having an elliptical shaped profile, as shown in FIG. 9A.

[0255] According to another embodiment shown in FIG. 9A'', the damper lumen 44 in the quiescent state may have a dot shape. In this case, the deformable flow path restrictor 42 may have a circular shaped profile, as shown in FIG. 9A''.

[0256] Alternatively, in an embodiment not shown in the accompanying drawings, the damper lumen 44 of the deformable flow path restrictor 42 may be a combination of Figures 9A and 9A". For example, the deformable flow path restrictor 42 may have an outer elliptical shape and the damper lumen 44 may have a dot shape when in the rest state. Similarly, the deformable flow path restrictor 42 may have an outer circular shape and the damper lumen 44 may have a line shape, i.e., straight or curved.

[0257] In one embodiment, the infusion line 51 may have an outer circular shape upstream and / or downstream of the pressure damper, as shown in Figures 9B, 10B, 11B, 12B, 13B and 14B. The outer circular shape of the infusion line 51 may be combined with an outer elliptical shape of the deformable flow restrictor 42, such as the outer elliptical shape shown in Figures 9A, 10A. Alternatively, the outer circular shape of the infusion line 51 may be combined with an outer circular shape of the deformable flow restrictor 42, such as the outer circular shape shown in Figures 9A", 10A", 11A, 11A", 12A, 12A". The outer circular shape of the infusion line 51 may also be combined with the embodiment described later, depicted in Figures 13 and 14, which includes a throttling device 90.

[0258] The deformable flow path restrictor 42 is also configurable to an infusion state, shown in Figures 10, 12, and 14 and in respective cross-sectional views 10A, 10A", 12A, 12A", and 14A. When the lumen pressure inside the deformable flow path restrictor 42 exceeds a predetermined threshold, the damper lumen 44 of the deformable flow path restrictor 42 switches to the infusion state, opening the damper lumen 44 to allow the passage of infusion fluid.

[0259] The predetermined threshold for opening the damper lumen 44 may be set to be greater than 1.02 times atmospheric pressure, in particular greater than 1.05 times atmospheric pressure, in particular greater than 1.1 or 1.2 times atmospheric pressure, or alternatively greater than 0.05 bar or 0.1 bar, optionally greater than 0.2 bar or 0.3 bar.

[0260] Thus, the elastic function of the deformable flow path restrictor 42 allows the damper lumen 44 to extend when subjected to internal pressure, thereby allowing an injection state, and then elastically contract to a rest state when the internal pressure falls below a predetermined threshold.

[0261] In other words, the deformable flow path restrictor 42 switches to the injection state when the opening force generated by the pressure inside the deformable flow path restrictor 42 exceeds the closing force provided by both the structural elasticity of the deformable flow path restrictor 42 and the external atmospheric pressure, thereby opening the internal damper lumen 44.

[0262] When a negative pressure, i.e. a pressure lower than atmospheric pressure, is generated in the blood circuit by the blood pump and thus in the infusion line downstream of the pressure damper, said negative pressure also contributes to keeping the deformable flow path restrictor 42 in a quiescent state. In this case, the pressure differential acting on the pressure damper generates a closing force on the deformable flow path restrictor 42, thereby providing an additional force contribution to keep the damper lumen 44 closed.

[0263] The damper lumen 44 of the deformable flow restrictor 42 may extend in the flow direction by a length comprised between 5 mm and 100 mm, in particular between 10 mm and 50 mm, optionally between 10 mm and 30 mm.

[0264] Whereas in the rest state the deformable flow path restrictor 42 has a linear folded damper lumen as shown in Figures 9A, 11A and 13A, in the injected state the deformable flow path restrictor 42 may have a lumen cross-section having a generally elliptical shape as shown in Figures 10A, 12A and 14A.

[0265] Alternatively, if in the rest state the deformable flow path restrictor 42 has a dot-shaped folded damper lumen, as shown in Figures 9A" and 11A", in the injected state the deformable flow path restrictor 42 may have a lumen cross-section having an approximately circular shape, as shown in Figures 10A" and 12A".

[0266] 9A-14, the deformable flow path restrictor 42 may be a conduit of the injection line 51. In particular, the deformable flow path restrictor 42 may be made as a single piece. In other words, the deformable flow path restrictor 42 may not include multiple pieces assembled together, but may be fabricated as a single piece, i.e., a conduit, having the characteristics described above.

[0267] Additionally, the deformable flow restrictor 42 may be integral with the infusion line, in which case the deformable flow restrictor 42 and the infusion line are effectively a single seamless piece.

[0268] Alternatively, the deformable flow path restrictor 42, i.e., a single-piece deformable flow path restrictor 42, may be originally separate from the infusion line. In this case, the deformable flow path restrictor 42 may comprise a first connector configured to be connected to an upstream flow path of the infusion line and a second connector configured to be connected to a downstream flow path of the infusion line.

[0269] The wall of the deformable flow path restrictor 42 may have a thickness that is approximately equal to the thickness of the wall of the remainder of the infusion line, and in particular, may have a thickness that is approximately equal to the thickness of the upstream wall of the infusion line located upstream of the deformable flow path restrictor 42, as shown in Figures 9, 10, 13, and 14.

[0270] Alternatively, the wall of the deformable flow path restrictor 42 may have a thickness greater than the wall thickness of the remainder of the infusion line, and in particular may be thicker than the upstream wall thickness of the infusion line located immediately upstream of the deformable flow path restrictor 42, as shown in Figures 11 and 12.

[0271] Beyond the thickness of the tube wall of the deformable flow path restrictor 42, the deformable flow path restrictor 42 may be made from the same material as the rest of the infusion line, such as silicone, a silicone-based material, latex, PVC, or rubber.

[0272] Additionally, the deformable flow restrictor 42 and the infusion line 51 may be fabricated as a single piece without any seams.

[0273] The deformable flow path restrictor 42 may comprise a constricted lumen section 43, preferably disposed at least upstream of the damper lumen 44, and optionally also downstream of the damper lumen 44. The constricted lumen section 43 defines a narrowing of the inner lumen of the infusion line before the damper lumen 44. In particular, at least in the resting state, the lumen of the conduit of the infusion line 51 upstream of the deformable flow path restrictor 42 may gradually reduce in size towards the damper lumen 44 of the deformable flow path restrictor 42, which defines the constricted lumen section 43. The lumen gradually reduces its size in the constricted lumen section 43, not instantaneously, to allow the internal pressure to open the damper lumen 44 when fluid infusion is required. The infusion fluid may be pressurized by the infusion pump 54. The pressurized infusion fluid determines the opening force on the inner surface of the constricted lumen section 43, thereby contributing to opening the damper lumen 44, thereby facilitating the switch from the resting state to the infusion state.

[0274] The narrowed lumen section 43 may have a conical or frusto-conical shape with straight sidewalls. The narrowed lumen section 43 may define an angle between the section of the upstream conduit and the damper section of the deformable flow path restrictor 42 comprised between 10° and 45°.

[0275] Alternatively, the narrowed lumen section 43 may extend its length along a curved path.

[0276] The constricted lumen section 43 may extend along the flow direction for a length of at least 2 mm, in particular at least 5 mm, optionally between 2 mm and 20 mm.

[0277] The pressure damper 40 may comprise a throttle device 90 acting on the deformable flow path restrictor 42, in particular the conduit of the deformable flow path restrictor 42, as shown in Figures 13 and 14. In particular, the throttle device 90 is configured to allow the deformable flow path restrictor 42 to move between a rest state, i.e. when the damper lumen 44 is substantially closed or significantly reduced, and an injection state, in which the damper lumen 44 is open to allow the injection fluid to pass through. The deformable flow path restrictor 42 connectable to the throttle device 90 is according to the embodiment previously described and shown in Figures 9 to 14, in particular the deformable flow path restrictor 42 is elastically deformable to switch between the rest state and the injection state.

[0278] The throttling device 90 is configured to provide a closing force contribution to keep the damper lumen 44 substantially closed in the rest state, as shown in Fig. 13. Furthermore, the throttling device 90 is also configured to enable the deformable flow path restrictor 42 to switch to the infusion state when the pressure in the infusion line exceeds a predetermined threshold. The predetermined threshold has already been detailed in the description, in particular the predetermined threshold for opening the damper lumen 44 may be greater than 1.02 times atmospheric pressure, in particular greater than 1.05 times atmospheric pressure, in particular greater than 1.1 or 1.2 times atmospheric pressure. Alternatively, the predetermined threshold may be greater than 0.05 bar or 0.1 bar, optionally greater than 0.2 bar or 0.3 bar.

[0279] The throttle device 90 is arranged around the deformable flow path restrictor 42 and exerts a compressive action on the outer surface of the deformable flow path restrictor 42. For example, the throttle device 90 may comprise a respective plate / plates 92 which exert a thrust on the outer surface of the deformable flow path restrictor 42. The plate 92 may have a flat shape. The plate 92 may extend along the flow direction for a length of more than 1 cm, in particular more than 2 cm. In particular, the plate 92 may extend for a length between 1 cm and 5 cm, or between 1 cm and 3 cm.

[0280] The throttle device 90 may comprise an elastic element 91, optionally a helical spring, or a leaf spring, or a spring-like element, configured to maintain a rest state. The elastic element 91 exerts a thrust on the outer surface of the deformable flow restrictor 42, pressing against the deformable flow restrictor 42, in particular against the conduit of the deformable flow restrictor 42. A plate 92 may be interposed between the elastic element 91 and the deformable flow restrictor 42 in contact therewith.

[0281] The elastic element 91 of the throttle device 90 may be preloaded in the rest state, so that in the rest state the throttle device 90 exerts a closing force on the deformable flow path restrictor 42 to maintain the rest state. Optionally, the magnitude of the preload of the elastic element 91 may be adjustable, i.e. manually adjustable by an operator.

[0282] Extracorporeal blood treatment device1 With reference to Fig. 1, the numeral 1 generally designates an extracorporeal blood treatment device, in particular for intensive care, configured to receive the disposable set previously described. The extracorporeal blood treatment device 1 is designed to perform any of the following treatments, for example: hemodialysis, hemofiltration, hemodiafiltration, ultrafiltration, etc.

[0283] The device according to FIG. 1 is especially designed for continuous renal replacement therapy (CRRT). The CRRT system is configured to perform a very specific treatment designed for patients who have fallen into an acute disease state and have temporarily lost total renal function. In this respect, the CRRT system may be structurally and / or operationally different from extracorporeal blood treatment systems designed for chronic patient care. In contrast to chronic patients, acute patients experience a temporary total loss of renal function, typically due to a concurrent state of severe injury or during recovery from surgery. As a result, acute patients are often extremely debilitated and are usually not in a condition to receive regular dialysis treatment, which may further worsen the condition and result in severe and possibly life-threatening complications. Under the circumstances as described, the CRRT system is designed to treat patients individually who present a very poor health condition, in particular without deviations of the vital parameters related to the patient's blood from ideal or near-ideal values ​​and without further stress on the patient's body. Thus, within the scope of this document, the CRRT system is essentially characterized by one or more of the following features: CRRT includes renal replacement therapy, which refers to an adjunctive therapy aimed initially at promoting sustained fluid removal in patients with diuretic resistance or acute renal failure. Thus, CRRT systems essentially require continuous net fluid removal from the patient. In other words, CRRT systems require a fluid balance control system, such as a weight loss control system, configured to generate a continuous net weight loss rate (as opposed to simply controlling parameters to allow for a desired target weight loss to be achieved as typically seen in chronic patient care). Additionally, acute patients experience extravascular fluid excess that cannot be safely removed within a short period of time (e.g., within a few hours of chronic treatment) without causing potentially serious consequences (e.g., hypovolemic shock, arrhythmias, hypoxemia, hypoventilation, etc.).Therefore, CRRT systems must inherently include much more precise control over system parameters, especially flow rates, to ensure that the required low flow rates of both the extracorporeally circulating blood and the treatment fluid (injected into the extracorporeal circuit or diffused through the dialyzer) are used. Furthermore, CRRT treatment is performed continuously (e.g., for days or weeks with no / minimal interruptions, e.g., downtime for changing bags). Thus, treatment settings in CRRT are based on flow rate settings, rather than settings related to a specific treatment time (which would be unknown, since an acute patient may require treatment for an unknown amount of time). Thus, the operation of a CRRT system cannot be based on some predefined absolute weight loss to be achieved, but rather on a carefully controlled fluid balance in the patient, requiring continuous adjustments to a number of operating parameters that must be controlled and maintained throughout the (previously unknown) treatment time, based on a set weight loss rate. Additionally, CRRT renal replacement therapy involves treatment to replace kidney function for a relatively long period of time, and therefore, CRRT systems further require at least one of a fresh exchange of dialysate in the dialyzer (to remove undesirable substances from the blood and add desired substances to the blood by diffusion) and / or a fresh infusion fluid in combination with ultrafiltration (to remove undesirable substances from the blood and add desired substances to the blood by convection).

[0284] For at least the reasons stated above, a CRRT system must exhibit certain technical features that enable the system to:

[0285] -Allows you to set the weight loss rate, -Continuously remove excess water according to a set weight loss rate; - Operate continuously at relatively low flow rates compatible with CRRT; and -Balance the ionic equilibrium by performing appropriate dialysis and / or by substitution fluid delivered continuously at a controlled flow rate.

[0286] Finally, in order to set up the CRRT device as quickly as possible, the CRRT machine is equipped with an integrated disposable set 100, with all lines and filtration units grouped together and already properly connected within the disposable set. Furthermore, all fluids are contained in pre-packaged bags (e.g., dialysis or substitution fluids in 2, 5 or 10 liter bags, respectively) or in pre-packaged syringes (heparin and / or concentrated calcium substitution solutions).

[0287] The apparatus 1 of FIG. 1 has an extracorporeal blood circuit 17 that draws blood from a patient P, e.g., introduced into a vein or artery of the patient via a needle or catheter, or an implanted port or other access device (not shown), and draws the blood, e.g., continuously, into the filtration unit 2 via a blood draw line 6.

[0288] The blood passes through the primary chamber 3 of the filtration unit 2 and through the blood return line 7, the treated blood is returned to the patient. In the example of FIG. 1, the connection with the infusion line 51 is provided immediately downstream of the blood collection zone on the blood collection line 6. In particular, the machine comprises an infusion substance source 10, which contains an infusion fluid, for example one of the following: bicarbonate, citrate or citric acid, substitution fluid, saline, and local anticoagulant solution. By using an infusion pump 54, for example a peristaltic pump, it is possible to control the flow of fluid in the infusion line 51 by directly connecting it to the blood collection line 6 and introducing the infusion fluid directly into the blood. After defining the direction of the fluid (blood) circulation 200 (during normal use of the device) from the blood collection line 6 towards the filtration unit 2 and from the filtration unit 2 through the blood return line 7 towards the patient P, a known blood pressure sensor 48, which will not be described in more detail, can be placed immediately downstream of the infusion line 51, i.e. between the infusion line 51 and the blood pump 21. The device is capable of detecting an appropriate blood flow Q in the circuit. bThe blood pump 21 is generally a peristaltic pump acting on either the blood draw line (e.g., as shown in FIG. 1) and / or the blood return line. The operator can control the blood flow rate Q via the user interface 15. b A set value of the blood flow rate may be inputted, and the control unit 12 is configured to control the blood pump based on the set blood flow rate during the treatment. Alternatively, the blood pump 21 may be automatically controlled without requiring user input / instruction, in which case it should be noted that the control unit 12 may control the blood pump 21 at a predefined flow rate or at a calculated flow rate based on other parameters, such as other flow rates and constraints set by a medical operator (as will be clear from the following description). Additionally or alternatively, the blood pump may be controlled based on pressure. If the blood pump 21 is controlled based on a pressure signal detected upstream of the blood pump, the pressure sensor 48 is present in the blood flow path upstream of the blood pump 21. For example, the control unit 12 may be designed to drive the blood pump to maintain the pressure detected by the pressure sensor 48 within a predetermined range or below a predetermined threshold.

[0289] Following the direction of blood circulation 200, the device 2 If configured to also remove CO from the circulating blood 2 A gas exchanger 46 may be connected to the blood circuit for removing CO. The gas exchanger 46 is in fluid communication with the blood circuit 17 for receiving extracorporeal blood and for removing CO from the blood. 2 1 shows the gas exchanger 46 located upstream of the filtration unit 2, the gas exchanger may alternatively be located downstream of the filtration unit on the blood return line 7. In particular, the gas exchanger 46 may be located downstream of the filtration unit 2, ... 2 If the gas exchanger 46 is placed downstream of the filtration unit 2 on the blood return line 7, the importance of degassing in the blood collection line increases, since air bubbles in the filtration unit can cause blood clotting. As mentioned above, the blood circulation direction during normal use of the device is b1 with a directional arrow 200. The gas exchanger 46 is connected in series with the filtration unit 2 and is located downstream of the injection point 50 where the infusion solution is delivered to the extracorporeal blood. The gas exchanger 46 is connected in series with the filtration unit 2 and is located downstream of the injection point 50 where the infusion solution is delivered to the extracorporeal blood. 2 The gas exchanger has a blood chamber and a gas chamber separated by a membrane that is permeable to CO, and the gas exchanger has a gas inlet that can be connected to a gas source, such as a medical gas supply system in a hospital, for example to receive pressurized air or oxygen, and a gas inlet that can be connected to a gas source, such as a medical gas supply system in a hospital, for receiving CO from the extracorporeal blood. 2 and a gas outlet in fluid communication with the gas chamber for discharging exhaust gases that have been stripped of CO. The blood inlet and blood outlet fluidly connect the extracorporeal blood circuit 17 to the blood chamber of the gas exchanger. 2 Obviously, if removal of gas is not required, the gas exchanger 46 need not be part of the dialyzer.

[0290] To control the correct flow in the blood circuit, another pressure sensor 49 may then be provided on the blood sampling line 6 , the pressure sensor 49 being interposed between the blood pump 21 and the filtration unit 2 .

[0291] After passing through the primary chamber 3 of the filtration unit 2, where a suitable exchange of substances, molecules and fluids takes place by the semipermeable membrane, the treated blood enters the blood return line 7 and passes first through an air separator 19, commonly known as a "bubble trap", designed to ensure the detection and removal of air bubbles present in the blood. The treated blood leaving the air separator 19, before being returned to the patient P, passes through an air bubble sensor 55 to ensure that said dangerous formations are not present in the treated blood that must be reintroduced into the patient's blood circulation. Immediately downstream of the air bubble sensor 55, a safety valve 20 (or venous clamp) is placed, which may block the blood flow towards the patient in case of an alarm. In particular, if the air bubble sensor 55 detects the presence of air in the blood flow, the machine may immediately block the passage of blood through the safety valve 20 to avoid any effects on the patient. A corresponding safety valve 27 (or arterial clamp) is present on the blood withdrawal line and closes the patient's vascular access, if necessary, to completely isolate the patient from the extracorporeal blood circuit. Downstream of the safety valve 20, the treated blood is returned to the patient P undergoing treatment. The extracorporeal blood treatment device of FIG. 1 comprises a dialysis fluid circuit 32, which is also provided with at least a dialysis supply line 8 leading to the filtration unit 2, and an effluent (or dialysate) line 13 from the filtration unit. At least one primary fluid container defining a dialysate source 14 is designed to supply the supply line 8 of the dialysate circuit 32 (typically the primary fluid container is composed of one or more bags containing a suitable dialysate). The supply line 8 is connected to the dialysate flow rate Q from the bags. dialand for defining the direction 200 of the dialysis fluid circulation. Downstream from the dialysis fluid pump 25 in the circulation direction 200 there is a branch 56 which divides the dialysis supply line 8 into an intake branch 57 and an infusion branch 58. In particular, the infusion branch 58 is connected to the blood return line 7 of the blood circuit 17. In other words, via said infusion branch 58 it is possible to obtain a post-infusion directly in the blood line 17 using the contents of the primary fluid container. Conversely, the infusion branch 57 conveys the fluid directly to the filtration unit 2, in particular to the secondary chamber of said unit. The dialysis fluid circuit 32 further comprises a selector 59 for determining the percentage of the fluid flow in the infusion branch 58 and in the intake branch 57. Generally, said selector 59 is usually placed near the branch 56 and may be arranged at least between a first operating state allowing the passage of fluid in the intake branch 57 and blocking the passage in the infusion branch 58, and a second operating state allowing the passage of fluid in the infusion branch 58 and blocking the passage in the emergency branch 57. In other words, said selector 59 may consist of a valve element operating on the dialysis fluid circuit 32 by alternately blocking the passage of fluid in either branch. Alternatively, a suitable selector may be provided that allows pre-establishing (setting) the amount of fluid that must pass through both branches simultaneously. It is also possible to vary the proportion (percentage) of fluid in either branch depending on the time and the pre-established treatment. The dialysate enters the secondary chamber 4 of the filtration unit 2 through the intake branch 57. In particular, the primary chamber 3 through which the blood flow passes is separated from the secondary chamber 4 through which the dialysate passes through the semipermeable membrane 5, ensuring the proper passage of dangerous substances / molecules and fluids going from the blood to the dialysate mainly via convection and diffusion processes, and also the passage of substances / molecules going from the dialysate to the blood via the same principles. The dialysis fluid then enters the effluent line 13 and passes through a suitable effluent pressure sensor 60. An actuator for conveying the fluid, e.g., the flow rate Q in the effluent line 13 in the fluid circuit 32, is effA dialysate pump 26 is provided that controls the flow of the dialysate through the dialysate pump 26, which is typically a peristaltic pump. The removed fluid then passes through a blood detector 61 and into a collection container or bag 62.

[0292] A further infusion line 51 may be provided for supplying fluid to the blood return line 7 of the blood circuit 17. In particular, the infusion fluid is taken from at least an auxiliary container 64 and is connected to the actuator(s) for conveying the fluid, generally at its flow rate Q rep-directly to the blood return line 7 of the blood circuit 17 via an infusion pump 65 (for example a peristaltic pump) that controls the total replacement flow rate. In particular, the infusion fluid may be introduced directly into the air separator 19. As can also be assumed, the infusion branch 58 of the dialysis fluid circuit 32 and the infusion line 63 comprise a common end length 66 that allows the fluid to flow into the blood circuit 17. Said suction end length 66 is arranged downstream of the infusion fluid pump 65 in relation to the direction of the infusion fluid and conveys the fluid directly into the air separator 19. Furthermore, with reference to the diagram of FIG. 1, the infusion line 63 comprises at least one pre-infusion branch 67 connected to the blood draw line 6 of the blood circuit 17. More particularly, downstream of the infusion pump 65 in relation to the direction of infusion there is an infusion branch 68 that divides the infusion line 63 into a pre-infusion branch 67 and a post-infusion branch 69. In particular, the pre-infusion branch 67 conveys the fluid taken from the bag 64 to the blood draw line 6 of the blood circuit 17 downstream of the blood pump 21 and downstream of the gas exchanger 46 with respect to the direction of blood circulation. Conversely, the post-infusion branch 69 is directly connected to the common end length 66. The infusion line 63 further comprises a selector 70 for determining the percentage of liquid flow sent to the post-infusion branch 69 and to the pre-infusion branch 67. The selector 70, located near the branch 68, may be switched between at least a first operating state allowing the passage of the fluid in the pre-infusion branch 67 and blocking the passage in the post-infusion branch 69 and at least a second operating state allowing the passage of the fluid in the post-infusion branch 69 and blocking the passage in the pre-infusion branch 67. Obviously, as in the case of the selector 59 present on the dialysis fluid circuit 32, the other selector 70 may also determine the percentage of the fluid that must pass in each of the two branches to vary in time according to the planned treatment. Furthermore, the selector 59 and the other selector 70 are generally, but not necessarily, of the same nature. In particular, the flow rate through the pre-injection branch / line 67 may be determined by appropriate control of the injector pump 65 and the other selector 70. The control unit 12 receives a pre-injection ratio PRE (a value between 0 and 1) of the replacement fluid flow and determines the pre-injection ratio PRE and the total replacement flow rate Q rep Based on the pre-injection flow rate Qrep.pre In particular, Q rep.pre =PRE·Q rep Alternatively, the post-injection ratio may be used symmetrically, as well as the ratio between pre-injection and post-injection (R=Q re.pre / Q rep.post ).

[0293] The device may comprise a scale 71 for determining at least the weight of the primary (main) fluid container 14 and / or the auxiliary fluid container 64 and / or the injectate source 10 and / or the collection container 62. In particular, said scale 71 comprises weight sensors, for example respective scales A, B, C, D and E (for example at least an independent sensor for each fluid bag associated with the machine). In particular, said scales are at least four, each independent of the other, each measuring a respective weight of a bag. It should then be noted that there is a control unit or CPU 12 active (at least) on the blood circuit 17, in particular on the pressure sensor 48 for reading pressure values, on the blood pump 21, on the gas exchanger 46, on the other pressure sensor 49 and on the device 55 for detecting the presence of air bubbles and on the respective safety valves 20, 27. The control unit 12 must also control the dialysis fluid circuit 32, in particular receiving the data detected by the scales A, B, C, D and (possibly) E, as well as the data relating to the weight of the bag 14, acting on the pump 25, the selector 59, the pressure sensor 60, then the dialysate pump 26, and finally receiving the data detected by the scale A, which has the function of determining the weight of the collection container 62. The control unit 12 can also act on the infusion line 63 to check the weight of the auxiliary container 64 (checked by the scale C) and control both the infusion pump 54 65 and the other selector 70. The control unit 12 also acts on the infusion line 51 to detect the weight of the infusion substance source 10 via the scale B and appropriately controls the infusion pump 54 according to the process carried out as detailed and explained below.

[0294] However, the apparatus of FIG. 1 may alternatively (or additionally) comprise a systemic anticoagulation system, such as a syringe pump 9 for injecting heparin downstream of the blood pump 21.

[0295] The control unit 12 is also connected to a memory and a user interface, for example a graphical user interface, for receiving operator input and displaying device output. For example, the graphical user interface may include a touch screen, a display screen and / or hard keys, or a combination thereof, for entering user input.

[0296] The control unit 12 is also connected to the blood pump 21 and is configured to control the blood pump 21 to determine the blood flow rate in the blood collection line 6. During the operating state of the extracorporeal blood treatment, the control unit is configured to define treatment conditions in which the blood pump 21 is set to a flow rate comprised between 50 ml / min and 600 ml / min, in particular between 100 ml / min and 350 ml / min, more in particular between 200 ml / min and 300 ml / min. Of course, the blood flow rate is set by the physician and may vary depending on various factors including the vascular access, the patient's condition and the type of treatment.

[0297] In either case, negative access pressure is experienced within the blood draw line 6 upstream of the blood pump passage 6p engaged by the blood pump 21 during patient treatment.

[0298] In turn, the infusion pump 54 is operatively connected to a control unit 12 configured to selectively control the infusion pump 54 to encourage the infusion fluid to flow through the infusion line 51 and deliver the infusion fluid into the infusion line 6. The control unit 12 may be configured to control the infusion fluid pump 54 to set the flow rate of the infusion fluid to a rate typically between 200 ml / h and 4000 ml / h, particularly between 500 ml / h and 2000 ml / h, more particularly generally close to 1000 ml / h and less than 1600 ml / h. Also in this regard, the type of treatment, the contents of the infusion fluid bag, and other conditions will determine the set infusion rate, which will typically be set within the ranges mentioned above.

[0299] The control unit may also be configured to stop the infusion fluid pump 54 to stop the delivery of infusion fluid.

[0300] According to embodiments in which the disposable set includes a one-way valve 46, the control unit may be configured to define a first state and a second state.

[0301] In the first state, the infusion fluid pump 54 operates to generate a flow of infusion fluid toward the blood collection line 6, and the blood pump 21 operates to determine the blood flow in the blood circuit of the disposable set. In the first state, the pressure difference across the one-way valve is higher than the preset opening pressure threshold of the one-way valve 46. This pressure difference causes the one-way valve 46 to switch to or remain in an open position, thereby allowing the infusion fluid to be delivered into the blood collection line 6. In other words, the infusion pump 54 generates an overpressure, which, in combination with the underpressure caused by the blood pressure, determines the opening of the one-way valve 46.

[0302] In the second state, the infusion fluid pump 54 is stopped to prevent infusion of infusion fluid into the blood draw line 6 while the blood pump is running. In the second state, the one-way valve 46 closes, preventing the infusion line 51 from being in fluid communication with the blood line. Negative access pressure is prevented from extending into the infusion line 51, thereby avoiding degassing of the infusion fluid.

[0303] The infusion pump 54 may be configured to generate a head pressure greater than a predetermined threshold in order to open either the one-way valve 46, 75 or the deformable flow path restrictor 42. In particular, the infusion pump 54 may be configured to generate a head pressure greater than 0.05 bar or 0.1 bar, and optionally greater than 0.2 bar or 0.3 bar, when an infusion of infusion fluid is required in the blood circuit 17. In particular, this head pressure is expressed as a relative pressure with respect to atmospheric pressure. Thus, a head pressure of 0.05 bar expressed as a relative pressure corresponds approximately to an absolute pressure of 1.05 bar.

[0304] Infusion pump 54 may comprise an occlusion pump or a positive displacement pump, such as a peristaltic pump.

[0305] 7 shows an embodiment in which a disposable set 100 for extracorporeal blood treatment, e.g. dialysis treatment, is connected to an extracorporeal membrane oxygenation ECMO circuit 300, which is configured to connect to a patient. In other words, the ECMO circuit 300 is fluidly interposed between the disposable set 100 and the patient's vascular access.

[0306] The ECMO circuit is only very diagrammatically represented to show the additional extracorporeal blood flow circulation. Obviously, the ECMO circuit includes all lines and components necessary for proper operation. No further details on the detailed embodiment of the ECMO circuit are provided. In any case, the skilled person knows the main features of the ECMO circuit and the main elements / devices involved without further explanation. In particular, the ECMO circuit is not part of the present invention as such, but is an additional circuit to which the disposable set 100 of the present invention may be coupled, instead of directly connecting the disposable set 100 to the patient. Indeed, when blood oxygenation and dialysis treatment are appropriate, the layout proposed in FIG. 7 may be implemented to avoid multiple blood accesses to the patient.

[0307] Obviously, any suitable connection of the extracorporeal blood circuit 100 to the ECMO device may be used. The blood draw line 6 and / or the blood return line 7 may be connected to the respective blood lines of the ECMO device where positive or negative pressure occurs. Below, two examples of possible connections are briefly described. However, what is relevant here is that (i) the extracorporeal blood circuit 100 may not be directly connected to the patient access, and (ii) any one of the blood draw line 6 and the blood return line 7 may experience a negative pressure regime, and therefore a corresponding pressure damper may be usefully applied at the junction of any infusion line infusing into the blood circuit where negative pressure exists in the blood at the junction.

[0308] According to the embodiment of FIG. 7, the blood draw line 6 of the disposable set 100 is connected to the ECMO circuit 300 downstream of the blood pump 321 of the ECMO circuit, and the blood return line 7 of the disposable set 100 is connected to the ECMO circuit 300 upstream of the blood pump 321 of the ECMO circuit. In this case, the blood draw line 6 of the disposable line experiences a positive pressure. Thus, the pressure at the intersection between the blood draw line 6 and the infusion line 51 in the disposable set 100 prevents degassing of the infusion fluid. However, the blood return line 7 may experience a negative pressure regime. In this case, the use of a pressure damper located close to or at the first end of the post infusion line 69 may be used to prevent degassing of the post infusion line itself. The pressure damper is configured to prevent or reduce the amount of negative pressure extending into the post infusion line 69 upstream of the pressure damper. The same embodiments of the pressure damper already discussed in the previous section can be used here.

[0309] In a second ECMO embodiment, not shown in the attached figures, the blood draw line 6 of the disposable set 100 may be connected to the ECMO circuit 300 upstream of the blood pump 321 of the ECMO circuit, while the blood return line 7 of the disposable set 100 may be connected to the ECMO circuit 300 downstream of the blood pump 321 of the ECMO circuit. In this case, the pressure in the fluid access 48 between the blood draw line 6 and the infusion line 51 in the disposable set 100 may be negative. The infusion fluid in the infusion line 51 may thus be exposed to a low pressure that may cause degassing of the fluid. Thus, the disposable set according to the invention may make it possible to avoid degassing of the fluid in the fluid line 51 when connected to the ECMO circuit, when the blood line with the infusion line 51 is connected to the ECMO circuit upstream of the blood pump 321 of the ECMO circuit.

Claims

1. A disposable set for an extracorporeal blood treatment device (1), said disposable set (100) comprising: - a filtration unit (2), - a blood circuit (17), a blood collection line (6) extending between a first end (6a) connected to the filtration unit (2) and a second end (6b); a blood return line (7) extending between a first end (7a) connected to the filtration unit (2) and a second end (7b); a blood circuit (17) comprising: the blood collection line (6) includes a blood pumping path (6p) configured to be engaged by a blood pump (21) of the extracorporeal blood treatment device (1) configured to determine blood flow, wherein, at least during an operating state, a negative access pressure is experienced upstream of the blood pumping path (6p), and the blood flow in the blood circuit (17) is in a direction from the blood collection line (6) towards the filtration unit (2) and from the filtration unit (2) through the blood return line (7); an infusion line (51) extending upstream of the blood pump line (6p) between a first end (51a) connected to the blood collection line (6) at a fluid access and a second end (51b) for connection to an infusion substance source (10), the blood pump line (6p) comprising an infusion line (51) interposed between the filtration unit (2) and the first end of the infusion line (51), the infusion line (51) comprising a respective infusion pump line (51p) interposed between the first and second ends of the infusion line (51), the infusion pump line (51) being configured to be engaged by an infusion peristaltic pump configured to determine a positive pressure downstream of the infusion pump line so as to allow infusion fluid to flow in a direction towards the first end of the infusion line (51) and towards the blood collection line (6), at least during an operating state; The disposable set further comprises a pressure damper (40) disposed adjacent to or at the first end of the infusion line (51), the pressure damper (40) being configured to prevent or reduce the amount of negative access pressure from extending into the infusion line (51) upstream of the pressure damper (40), the pressure damper (40) being disposed on the infusion line (51) between the infusion pump path (51p) and the blood circuit (17).

2. the pressure damper (40) comprises a one-way valve (46) configured to allow fluid passage only in an injection direction from the injection line (51) to the withdrawal line (17), and configured to move between an open position in which fluid passage is permitted in the injection direction and a closed position in which fluid passage is prevented in both directions; The one-way valve (46) is preset to an opening pressure threshold to switch between the closed position and the open position, and vice versa, so that: the one-way valve (46) is configured to switch to or maintain the open position when the pressure difference between the upstream and downstream sections of the one-way valve (46) is equal to or greater than the opening pressure threshold; 2. The disposable set according to claim 1, wherein the one-way valve (46) is configured to switch to or remain in the closed position if the differential pressure is less than the opening pressure threshold.

3. 3. The disposable set according to claim 2, wherein the pressure difference is defined between a high pressure zone upstream of the one-way valve (46) and a low pressure zone downstream of the one-way valve (46) according to the injection direction, the high pressure being higher than the low pressure, and the one-way valve (46) prevents fluid passage in the direction from the collection line (6) to the injection line (51).

4. 3. The disposable set of claim 2, wherein the one-way valve (46) comprises an internal diaphragm (46a) movable between the open position and the closed position, the internal diaphragm (46a) being preloaded in the closed position, the preload defining the preset opening pressure threshold.

5. The one-way valve (46) is a duckbill valve (75) having a housing (76) defining an interior volume (76a), the housing (76) comprising: an inlet connector (75a) connected to the upstream flow path of said injection line (51); an outlet connector (75b) connected to the downstream path of said injection line (51); a duckbill element (77) disposed within the internal volume (76a) of the housing (76) and configured to allow the injection fluid to flow from the inlet connector (75a) to the outlet connector (75b) and to prevent fluid from flowing back from the outlet connector (75b) to the inlet connector (75a), wherein the duckbill element (77) is made of a flexible and / or elastic material.

6. The duckbill component (77) of the duckbill valve (75) has a tapered shape extending between a wide passage section (77a) and a passage closure section (77b) for the fluid; the duckbill valve (75) is configured to allow the injection fluid to flow sequentially from the inlet connector (75a) into the wide passage section (77a), then through the passage closing section (77b) of the duckbill component (77), and then through the outlet connector (75b) of the duckbill valve (75); 6. The disposable set according to claim 5, wherein the widened passage section (77a) is fluid-tightly connected to the outlet of the inlet connector (75a) inside the internal volume (76a).

7. the passage closure section (77b) opens into the internal volume (76a) of the housing (76), the passage closure section (77b) is not connected to the outlet connector (75b); 7. The disposable set according to claim 6, wherein the passage closure section (77b) is cantilevered within the interior volume (76a) of the housing (76) of the duckbill valve (75).

8. The passage-closing section (77b) comprises a deformable slit, the deformable slit comprising: an open state in which the passage-closing section (77b) of the duckbill element (77) allows the injection fluid to flow from the inlet connector (75a) towards the outlet connector (75b), the open state of the slit defining the open position of the one-way valve; a closed state in which the passage closure section (77b) of the duckbill element (77) is closed to prevent fluid from flowing through the duckbill element (77), the closed state of the slit defining the closed position of the one-way valve; The disposable set according to claim 6, which is deformable between

9. 3. The disposable set of claim 2, wherein the preset opening pressure threshold of the one-way valve (46) is greater than 160 mmHg.

10. 10. The disposable set according to any one of claims 2 to 9, wherein the preset opening pressure threshold of the one-way valve (46) corresponds to a differential pressure value comprised between 160 and 500 mmHg, or between 190 and 450 mmHg, or between 200 and 400 mmHg, or between 240 and 350 mmHg.

11. 10. The disposable set according to claim 2, wherein the preset opening pressure threshold of the one-way valve (46) is set within + / - 100 mmHg of the maximum negative pressure allowed in the fluid access during standard operating conditions of the extracorporeal blood treatment device (1).

12. 10. The disposable set according to any one of claims 2 to 9, wherein the one-way valve (46) is located on the infusion line (51) at a distance of 6 cm or less from the first end of the infusion line (51).

13. A disposable set for an extracorporeal blood treatment device (1), comprising: - a filtration unit (2), - a blood circuit (17), a blood collection line (6) extending between a first end (6a) connected to the filtration unit (2) and a second end (6b); a blood return line (7) extending between a first end (7a) connected to the filtration unit (2) and a second end (7b); a blood circuit (17) comprising: the blood collection line (6) includes a blood pumping path (6p) configured to be engaged by a blood pump (21) of the extracorporeal blood treatment device (1) configured to determine blood flow, wherein, at least during an operating state, a negative access pressure is experienced upstream of the blood pumping path (6p), and the blood flow in the blood circuit (17) is in a direction from the blood collection line (6) towards the filtration unit (2) and from the filtration unit (2) through the blood return line (7); an infusion line (51) extending upstream of the blood pump line (6p) between a first end (51a) connected to the blood withdrawal line (6) in a fluid access and a second end (51b) for connection to an infusion substance source (10), the blood pump line (6p) comprising an infusion line (51) interposed between the filtration unit (2) and the first end of the infusion line (51); The disposable set further comprises a pressure damper (40) disposed adjacent to or at the first end of the infusion line (51), the pressure damper (40) configured to prevent or reduce the amount of negative access pressure from extending into the infusion line (51) upstream of the pressure damper (40), the pressure damper (40) comprising a deformable flow path restrictor (42) constructed of an elastic material, the deformable flow path restrictor (42) comprising: In the rest state, the deformable flow restrictor (42) is substantially closed to prevent fluid flow or is less than 1 mm ２ a damper lumen (44) defining a damper passage cross-section for infusion fluid having a size less than - in an infusion state, when a lumen pressure inside the deformable flow path restrictor (42) exceeds a predetermined threshold, the damper lumen (44) of the deformable flow path restrictor (42) is configured to open to allow the passage of the infusion fluid; Disposable set that can be configured as follows.

14. 14. The disposable set of claim 13, wherein the predetermined threshold for opening the damper lumen is greater than 1.02 times atmospheric pressure, or 1.05 times atmospheric pressure, or 1.1 times atmospheric pressure, or 1.2 times atmospheric pressure, or greater than 0.05 Bar, or 0.1 Bar, or 0.2 Bar, or 0.3 Bar.

15. 15. The disposable set according to claim 13 or 14, wherein the damper lumen (44) of the deformable flow path restrictor (42) extends in the flow direction by a length comprised between 5 mm and 100 mm, the deformable flow path restrictor (42) has a folded damper lumen (44) in the rest state with a cross-sectional shape between a line and a point, the deformable flow path restrictor (42) is a conduit of the infusion line (51), the conduit of the deformable flow path restrictor (42) has a flat shape, and the conduit has a cross section perpendicular to the flow direction with an outer shape of an ellipse.

16. the deformable flow restrictor (42) is a conduit of the injection line (51); the wall of the deformable flow restrictor (42) has a thickness approximately equal to the thickness of the upstream wall of the injection line (51) located upstream of the deformable flow restrictor (42), or A disposable set according to claim 13 or 14, wherein the wall of the deformable flow path restrictor (42) has a thickness greater than the thickness of the upstream wall of the infusion line located immediately upstream of the deformable flow path restrictor (42).

17. 15. The disposable set according to claim 13 or 14, wherein, at least in the rest state, the lumen of the infusion line (51) conduit upstream of the deformable flow path restrictor (42) gradually reduces in size towards the damper lumen (44) of the deformable flow path restrictor (42) and defines a narrowed lumen section (43).

18. The pressure damper (40) includes a throttle device (90) that operates on a thrust force on a conduit of the deformable flow restrictor (42), the throttle device (90) comprising: - providing a closing force contribution to keep said damper lumen (44) closed in said rest state; - enabling the deformable flow restrictor (42) to switch to the injection state when the pressure in the injection line upstream of the pressure damper exceeds a predetermined threshold; 15. The disposable set according to claim 13 or 14, configured to:

19. 19. The disposable set of claim 18, wherein the restrictor (90) is disposed around the periphery of the deformable flow restrictor (42) and exerts a compressive action against the outer surface of the deformable flow restrictor (42).

20. the throttle device (90) comprises an elastic element (91) acting with a thrust on the outer surface of the deformable flow restrictor (42); 19. A disposable set according to claim 18, wherein the elastic element (91) of the wringing device (90) is preloaded in the rest state.

21. 19. The disposable set of claim 18, wherein the restrictor (90) comprises one or more plates (92) that act with a thrust on the outer surface of the deformable flow path restrictor (42) along a length between 1 cm and 5 cm.

22. A disposable set for an extracorporeal blood treatment device (1), comprising: - a filtration unit (2), - a blood circuit (17), a blood collection line (6) extending between a first end (6a) connected to the filtration unit (2) and a second end (6b); a blood return line (7) extending between a first end (7a) connected to the filtration unit (2) and a second end (7b); a blood circuit (17) comprising: the blood collection line (6) includes a blood pumping path (6p) configured to be engaged by a blood pump (21) of the extracorporeal blood treatment device (1) configured to determine blood flow, wherein, at least during an operating state, a negative access pressure is experienced upstream of the blood pumping path (6p), and the blood flow in the blood circuit (17) is in a direction from the blood collection line (6) towards the filtration unit (2) and from the filtration unit (2) through the blood return line (7); an infusion line (51) extending upstream of the blood pump line (6p) between a first end (51a) connected to the blood withdrawal line (6) in a fluid access and a second end (51b) for connection to an infusion substance source (10), the blood pump line (6p) comprising an infusion line (51) interposed between the filtration unit (2) and the first end of the infusion line (51); the disposable set further comprising a pressure damper (40) arranged adjacent to or at the first end of the infusion line (51), the pressure damper (40) being configured to prevent or reduce the amount of the access negative pressure from penetrating into the infusion line (51) upstream of the pressure damper (40), the pressure damper (40) comprising a flow path restrictor (41); the flow path restrictor (41) has a damper passage cross-section configured to allow the injection fluid to pass through; the injection lines (51) have respective fluid passage cross-sections configured to allow the injection fluid to pass through; The disposable set, wherein the damper passage cross section extends for a length comprised between 30 mm and 200 mm, has a diameter comprised between 0.3 mm and 0.6 mm, and is at least 50% smaller than the fluid passage cross section.

23. - said damper passage cross section has a diameter equal to 0.5 mm and said damper passage extends for a length equal to 145 mm ±15 mm, or - said damper passage cross section has a diameter equal to 0.4 mm and said damper passage extends for a length equal to 60 mm ±10 mm; 23. The disposable set of claim 22, wherein the diameter is constant along the length.

24. The flow path restrictor (41) comprises a partition wall that defines the damper passage cross section, The cross section of the damper passage of the partition wall is along the fluid flow direction of the injection line (51) for a flow path length comprised between -1 mm and 30 mm; and - Radially with a diameter of 0.2 mm to 3 mm, extending in the axial direction, 24. A disposable set according to claim 22 or 23, wherein the damper passage cross section is constant along the flow path length.

25. the infusion lines (51) comprise respective infusion pump paths (51p) interposed between the first and second ends of the infusion lines (51), the infusion pump paths of the infusion lines (51) being configured to be engaged by an infusion peristaltic pump configured to determine a positive pressure downstream of the infusion pump paths so as to allow the infusion fluid to flow in a direction towards the first end of the infusion line (51) and towards the blood collection line (6), at least during an operating state; 24. Disposable set according to claim 22 or 23, wherein the pressure damper (40) is arranged on the infusion line (51) between the infusion pump path (51p) and the blood circuit (17).

26. A disposable set for an extracorporeal blood treatment device (1), said disposable set (100) comprising: - a filtration unit (2), - a blood circuit (17), a blood collection line (6) extending between a first end (6a) connected to the filtration unit (2) and a second end (6b); a blood circuit (17) comprising a first end (7a) connected to the filtration unit (2) and a blood return line (7) extending between a second end (7b); the blood collection line (6) includes a blood pump passage (6p) configured to be engaged with a blood pump (21) of the extracorporeal blood treatment device (1) configured to determine blood flow, such that at least during an operating state, a negative return pressure is experienced downstream of the filtration unit (2), and the blood flow in the blood circuit (17) is in a direction from the blood collection line (6) towards the filtration unit (2) and from the filtration unit (2) through the blood return line (7); a post-infusion line (69) extending between a first end connected to the blood return line (7) at a fluid access downstream of the blood pump path (6p) and a second end (63) for connection to an infusion substance source (64); the disposable set further comprises a pressure damper (40) disposed adjacent to or at the first end of the post-infusion line (69), the pressure damper (40) configured to prevent or reduce the amount of negative return pressure extending into the post-infusion line (69) upstream of the pressure damper (40); the pressure damper (40) comprises a one-way valve (46) configured to allow fluid passage only in an infusion direction from the infusion line (51) to the return line (17), and configured to move between an open position, in which fluid passage is permitted in the infusion direction, and a closed position, in which fluid passage is prevented in both directions; The one-way valve (46) is preset to an opening pressure threshold to switch between the closed position and the open position, and vice versa, so that: the one-way valve (46) is configured to switch to or maintain the open position when the pressure difference between the upstream and downstream sections of the one-way valve (46) is equal to or greater than the opening pressure threshold; a disposable set, wherein the one-way valve (46) is configured to switch to or maintain the closed position when the differential pressure is less than the opening pressure threshold.

27. 27. The disposable set of claim 26, wherein the preset opening pressure threshold of the one-way valve (46) corresponds to a differential pressure value greater than 160 mmHg, and the one-way valve (46) is positioned on the post-infusion line (69) at a distance of 6 cm or less from the first end of the post-infusion line (69).

28. 28. The disposable set according to claim 26 or 27, wherein the second end (6b) of the blood withdrawal line (6) and the second end (7b) of the blood return line are connected to blood ducts (306, 307) of a further extracorporeal blood circuit of an extracorporeal membrane oxygenation (ECMO) circuit (300).

29. 1. An assembly comprising: A disposable set for an extracorporeal blood treatment device, said disposable set comprising: a filtration unit (2), a blood circuit (17) comprising a blood sampling line (6) extending between a first end connected to the filtration unit (2) and a second end, and a blood sampling line (7) extending between a first end connected to the filtration unit (2) and a second end; the blood circuit (17) includes a pumping line configured to be engaged with a blood pump (21) of the extracorporeal blood treatment device configured to generate blood flow, and at least during an operating state, a negative access pressure exists upstream of the pumping line, and the blood flow in the blood circuit (17) is in a direction from the blood draw line (6) to the filtration unit (2) and from the filtration unit (2) through the blood return line (7); an infusion line (51) extending between a first end connected to the blood circuit (17) at a fluid access upstream of the blood pump line (6p) and a second end for connection to an infusion substance source (10), the blood pump line (6p) being interposed between the second end (7b) of the blood return line (7) and the first end of the infusion line (51); a disposable set comprising: a clamp (80) that engages a portion of the infusion line (51) and reduces its internal lumen without closing it, said clamp comprising: a handheld clamp (81) configured to receive a portion of the infusion line (51) and comprising a clamp seat having a fixed size to determine a predetermined lumen reduction of the infusion line (51); a variable clamp configured to receive a portion of the infusion line (51) and including a clamp seat having an adjuster for varying the luminal reduction of the infusion line (51); a clamp (80) comprising at least one of: the infusion lines (51) having respective fluid passage cross-sections configured to allow infusion fluid to pass therethrough when the clamps are not active on the infusion lines; the infusion line (51) having a damper passage cross-section configured to allow the infusion fluid to pass therethrough when the clamp is engaged on the infusion line and active to reduce its internal lumen; The assembly, wherein the damper passage cross section is 50% smaller than the fluid passage cross section.

30. 1. An extracorporeal blood treatment device comprising: a disposable set according to any one of claims 1 to 9, 13, 22, 26 or an assembly according to claim 29; a blood pump cooperating with said blood pump channel (6p) of said blood collection line (6); an injection pump (54) cooperating with an injection pump path (51p) of the injection line (51), the injection pump (54) being arranged between the second end of the injection line (51) downstream of the injection substance source (10) and upstream of the pressure damper (40); a control unit (12) operatively connected to the blood pump (21) and the infusion pump (54), the control unit (12) being configured to control the blood pump (21) and the infusion pump (54) with corresponding blood flow and infusion flow rates; the control unit is configured to define a process state; - said blood flow rate is comprised between 50 ml / min and 600 ml / min, an extracorporeal blood treatment device, wherein said infusion flow rate is comprised between 200 ml / h and 4000 ml / h;

31. The pressure damper (40) comprises a one-way valve (46); The control unit a first state in which the infusion pump (54) is active to determine fluid flow and a positive infusion pressure exists downstream of the infusion pump, and the blood pump is active to determine blood flow and a negative access pressure exists upstream of the blood pump; wherein the pressure difference between the positive infusion pressure and the negative access pressure is greater than the preset opening pressure threshold of the one-way valve (46) to allow the infusion fluid to enter the blood collection line (6); a second state in which the infusion pump (54) is stopped to prevent the infusion of infusion fluid into the blood collection line (6) and the blood pump (21) is active to determine the blood flow in the blood circuit, in which in the second state the difference between the pressure in the infusion line (51) and the negative access pressure is lower than the preset opening pressure threshold of the one-way valve (46), so that the one-way valve (46) is closed and prevents the negative access pressure from reaching the infusion line (51); configured to define the infusion pump (54) is configured to generate a head pressure greater than a predetermined threshold to open either the one-way valve (46; 75) or the deformable flow path restrictor (42); 31. The extracorporeal blood treatment device of claim 30, wherein the infusion pump (54) is configured to generate a head pressure greater than 0.2 bar or 0.3 bar.

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