Disposable circuits for extracorporeal blood processing, apparatus for extracorporeal blood processing, and related methods

Abstract

A manifold assembly for a peritoneal dialysis machine includes a casing (19) defining a first compartment (22) and a second compartment (23) therein, and a yielding pump tube (55) having a first end (56) connected to or connectable to the first compartment (22) and a second end (57) connected to or connectable to the second compartment (23). The yielding pump tube (55) extends outside the casing (19) to be coupled to a peristaltic pump (6) of a cycler (2) of the peritoneal dialysis machine (1). A first pump port (34) and a second pump port (35) are disposed on a first side of the casing (19), and ports (53, 36, 40, 41, 44) are disposed on a second side of the casing (19) opposite the first side.

Description

[Technical Field]

[0001] This disclosure relates to a manifold assembly for a peritoneal dialysis machine and a peritoneal dialysis machine equipped with said manifold assembly. This disclosure also relates to a method for controlling a peritoneal dialysis machine.

[0002] A person's kidney system can become dysfunctional due to various causes. Renal failure leads to several physiological disorders. The kidneys can no longer balance water and minerals, nor can they eliminate the daily metabolic burden. End products of metabolic toxicity, such as urea, creatinine, and uric acid, can accumulate in the patient's blood and tissues.

[0003] Kidney failure, particularly kidney failure, is treated with dialysis. Dialysis removes waste products, toxins, and excess fluid from the body that would normally be removed by a healthy kidney. Dialysis, a replacement for kidney function, is important for many people because it can save lives.

[0004] One type of treatment for renal failure is peritoneal dialysis ("PD"), in which a dialysis solution, also called dialysate, is injected into the patient's peritoneal cavity via a catheter. The dialysate comes into contact with the peritoneum within the patient's peritoneal cavity. Waste products, toxins, and excess fluid enter the dialysate from the patient's bloodstream through the capillaries of the peritoneum by diffusion and osmosis; that is, an osmotic gradient is created across the membrane. Osmotic agents in the PD dialysate provide this osmotic gradient. Used or depleted dialysate is drained from the patient, removing waste products, toxins, and excess fluid. This cycle is repeated, for example, multiple times. [Background technology]

[0005] There are various types of peritoneal dialysis treatments, including continuous ambulatory peritoneal dialysis ("CPAD"), automated peritoneal dialysis ("APD"), tidal flow dialysis, and continuous flow peritoneal dialysis ("CFPD"). CAPD is a manual dialysis treatment. Here, the patient manually connects an implanted catheter to a drain to allow used or depleted dialysate to drain from the peritoneal cavity. The patient then switches the fluid connection so that the patient's catheter communicates with a bag of unused dialysate and the unused dialysate is injected into the patient through the catheter. The patient disconnects the catheter from the bag of unused dialysate, allowing the dialysate to remain in the peritoneal cavity, where waste products, toxins, and excess fluid can move. After the retention period, the patient repeats the manual dialysis procedure, for example, four times a day. Manual peritoneal dialysis requires a significant amount of time and effort from the patient and leaves ample room for improvement.

[0006] Automated peritoneal dialysis ("APD") is similar to CAPD in that the dialysis treatment involves a cycle of draining, filling, and retaining. However, the APD machine automatically performs the cycle, typically while the patient is sleeping. The APD machine eliminates the need to manually perform the treatment cycle and the need to transport supplies during the day. The APD machine has fluid connections to an implanted catheter, a source or bag of unused dialysate, and a fluid drain. The APD machine delivers unused dialysate from the dialysate source through the catheter into the patient's peritoneal cavity. The APD machine also allows the dialysate to remain in the chamber, moving waste products, toxins, and excess fluid. The source may contain several liters of dialysate, including several solution bags.

[0007] The APD machine delivers used or depleted dialysis fluid from the patient's peritoneal cavity through a catheter to a drain. Similar to the manual process, several draining, refilling, and retention cycles occur during dialysis. The "final refill" may occur at the end of APD treatment. The final refill fluid may remain in the patient's peritoneal cavity until the next treatment begins, or it may be manually emptied at some point during the day.

[0008] Known APD systems include machines or cycloras that accept and operate disposable pump devices or cassettes having rigid and deformable soft parts to perform pumping and valve operations.

[0009] Most cyclonic machines on the market implement a pumping system based on the compression / expansion of liquid volume within an expansion chamber, which is part of a disposable device (alternating pumping system). Compression / expansion is performed by the action of a flexible diaphragm incorporated into the chamber of the disposable device, resulting in a continuous flow of a liquid mass in a volume linked to the volume of the expansion chamber itself. In such designs, the flow rate and the resulting liquid exchange rate are controlled by utilizing the "law of ideal gases," combined with knowledge of the chamber volume and pressure monitoring.

[0010] Systems of this type for performing peritoneal dialysis are disclosed, for example, in U.S. Patent Application Publication No. 2011 / 0092893 and U.S. Patent Application Publication No. 2020 / 0230310.

[0011] The main identified drawback of this approach is related to managing and adjusting low fluid flow rates, i.e., flow rates that are orders of magnitude smaller than the volume of the device's expansion chamber (typically >15 ml). In such ranges, alternating pump systems lead to discretization of the flow with a reduced level of precision. The ability to carefully manage low flow rates is particularly important in the stage of fluid drainage from the patient, which is often reported as a painful stage of treatment for the patient.

[0012] Furthermore, the alternating pump approach results in a slight pulsatile flow, which does not show optimal results even in the aforementioned stages of draining and administering fluid from the patient, compared to the smooth laminar flow method.

[0013] Furthermore, sealing liquid disposable devices with a pneumatic path via a gasket to provide operation has proven to be a potential field issue, potentially delaying treatment initiation time and impacting the user experience.

[0014] The pneumatic cassette system also generates acoustic noise, which can be a source of customer dissatisfaction.

[0015] Some types of cyclizing machines utilize the use of scale to control the amount of fluid being replaced. A drawback of this approach is that the scale present in the cyclizing machine needs to be calibrated accurately and frequently, and this procedure is susceptible to errors, complicating operations for cyclizing machine maintenance management.

[0016] An additional drawback common to existing solutions is the lack of a way to manage and remove the potential presence of air bubbles in the "PD" solution administered to patients.

[0017] Systems that perform peritoneal dialysis via a peristaltic pump are also known. For example, such systems are disclosed in International Publication No. 2012 / 129501 A2, International Publication No. 2019 / 169081, U.S. Patent Application Publication No. 2005 / 0209563, and International Publication No. 2018 / 237375.

[0018] These systems also have drawbacks related to the need for calibration, pulsating flow, and bubble removal.

[0019] Therefore, an object of the present invention is to provide a manifold assembly and a peritoneal dialysis apparatus for which more precise and simpler control of fluid flow and enhanced monitoring of the effectiveness of peritoneal dialysis treatment are possible.

[0020] An object of the present invention is to provide a manifold assembly and a peritoneal dialysis device for a peritoneal dialysis device that can ensure a continuous flow that is adjustable and highly accurate even in a low flow rate range (for example, 5 to 10 ml / min).

[0021] A further object of the present invention is to provide a manifold assembly and a device that can manage the liquid level and ensure that the liquid level is maintained within a defined range.

[0022] A further object of the present invention is to provide a manifold assembly and a device that can attenuate the influence of the peristalsis of the pump and provide a flow that does not exhibit pulsations typical of prior art systems using an alternating pump system or a peristaltic pump.

[0023] A further object of the present invention is to provide a manifold assembly and a device that can shorten the treatment time.

[0024] A further object of the present invention is to provide a manifold assembly and a device that can detect the possibility of extremely negative pressure values occurring within the compartments of a chamber connected to a drain line and a bag line.

[0025] A further object of the present invention is to provide a manifold assembly and a device that can remove air bubbles that are present residentially in a "PD" solution before administration to a patient.

[0026] A further object of the present invention is to propose a manifold assembly and a device that can monitor the pressure value within the compartment of a chamber of a manifold assembly connected to a patient line and provide the possibility of adjusting the liquid level of the compartment of the chamber.

[0027] A further object of the present invention is to provide a manifold assembly that is reliable and can be easily spliced / connected to the hardware components of the cycler of the device.

[0028] A further object of the present invention is to provide a manifold assembly that can be easily handled by the user, easily attached to and removed from the cyclorama of the device. [Overview of the project]

[0029] At least one of the above-mentioned objectives is substantially achieved by the manifold assembly for a peritoneal dialysis apparatus and the peritoneal dialysis apparatus according to one or more of the attached claims.

[0030] Manifold assemblies for peritoneal dialysis machines, peritoneal dialysis machines, and methods for controlling peritoneal dialysis machines, according to aspects of the present invention, which can achieve one or more of the above-described objectives, are disclosed below.

[0031] The first aspect relates to a manifold assembly for a peritoneal dialysis machine, comprising a casing that internally defines a first compartment and a second compartment, and a yielding pump tube having a first end connected to or connectable to the first compartment and a second end connected to or connectable to the second compartment, wherein the yielding pump tube extends outward from the casing so as to be coupled to the peristaltic pump of the peritoneal dialysis machine, and a plurality of line tubes each having a first end connected to or connectable to the first compartment or the second compartment and a second end connected to or connectable to a fluid supply source or drain or patient.

[0032] Optionally, the line tubes include a patient line tube having a first end connected to or connectable to a second compartment and a second end connectable to the patient's peritoneal cavity; at least one liquid line tube having a first end connected to or connectable to a first compartment and a second end connected to or connectable to a fluid source and / or drain; and optionally, at least one liquid line tube having a first end connected to or connectable to a second compartment and a second end connected to or connectable to a fluid source.

[0033] The first compartment, the yielding pump tube, and the second compartment together define a fluid path extending between at least one fluid line tube having a first end connected to the first compartment and the patient line tube, allowing for the flow of fluid at least from at least one fluid line tube having a first end connected to the first compartment to the patient line tube, or from the patient line tube to at least one fluid line tube having a first end connected to the first compartment, when the cyclorama's peristaltic pump is activated.

[0034] The second aspect relates to a peritoneal dialysis apparatus comprising a manifold assembly according to the first aspect or one or more of the following aspects.

[0035] A third aspect relates to a method for controlling the peritoneal dialysis apparatus of the preceding aspect.

[0036] In a fourth embodiment according to the first aspect, the manifold assembly comprises a hook element configured to removably hook a disposable assembly onto the cyclor, optionally onto the front panel of the cyclor, and / or the casing is molded to removably hook onto the cyclor, optionally onto the front panel of the cyclor, and optionally the manifold assembly is at least partially disposable or reusable.

[0037] In a fifth embodiment, which may be used in conjunction with any other embodiments described herein, the second compartment defines at least one expansion chamber configured to attenuate pressure pulsations from a peristaltic pump, and optionally, at least one expansion chamber is at least partially defined by a soft membrane, which optionally is made of a plastic sheet, optionally a polyvinyl chloride sheet.

[0038] In a sixth embodiment, which may be used in conjunction with any other embodiments described herein, the casing has a substantially flat shape.

[0039] In a sixth embodiment, which may be used in conjunction with any other embodiments described herein, the casing comprises a front, a rear and a number of sides, the rear optionally configured to be coupled to the front panel of the cycra.

[0040] In the sixth-third embodiment according to the previous aspect, the first pump port and the second pump port are located on the first side of the casing, and the ports are located on the second side of the casing opposite to the first side.

[0041] In the sixth four embodiment according to the previous aspect, the casing has a substantially rectangular shape having two long sides and two short sides, optionally the first and second sides being both long sides of the casing.

[0042] In a seventh embodiment, which may be used in conjunction with any other embodiments described herein, the first compartment and / or the second compartment have a flat shape, at least partially.

[0043] In an eighth embodiment, which may be used in conjunction with any other embodiments described herein, at least one liquid line tube comprises at least one dialysate line tube, optionally, at least one dialysate line tube having a first end connected to a first compartment, or at least one dialysate line tube having a first end connected to a second compartment.

[0044] In the ninth embodiment according to aspect 8, the liquid supply source connected to the second end of at least one dialysate line tube is a supply bag.

[0045] In the tenth embodiment according to aspect 8 or 9, at least one liquid line tube comprises a plurality of dialysate line tubes, optionally a first dialysate line tube and a second dialysate line tube.

[0046] In the 11th embodiment according to embodiment 10, each dialysate line tube is connected to a supply bag.

[0047] In a twelfth embodiment, which may be used in conjunction with any other embodiments described herein, at least one liquid line tube comprises a heater line tube, and optionally the heater line tube has a first end connected to a first compartment.

[0048] In the 13th embodiment according to embodiment 12, the liquid supply source connected to the second end of the heater line tube is a heater bag.

[0049] In the fourteenth embodiment according to embodiment 13, the heater bag is configured to be coupled to the heater of the cyclorama.

[0050] In the 14th embodiment according to embodiment 11, an auxiliary inline heater is provided on at least one liquid line tube to heat the dialysate as it flows through the dialysate line tube.

[0051] In a 15th embodiment, which may be used in conjunction with any other embodiments described herein, at least one liquid line tube comprises a drain liquid line tube, optionally the drain liquid line tube having a first end connected to a first compartment, and optionally at least one liquid line tube also comprises an auxiliary drain liquid line tube having a first end connected to a second compartment.

[0052] In the 16th embodiment according to embodiment 15, the drain fluid line tube and optionally the auxiliary drain fluid line tube have a second end connected to or connectable to the drain, and optionally the drain fluid line tube merges with the auxiliary drain fluid line tube in the common drain line before reaching the drain.

[0053] In a 17th embodiment, which may be used in conjunction with any other embodiments described herein, the yielding pump tube has a curved shape.

[0054] In an eighteenth embodiment, which may be used in conjunction with any other embodiments described herein, the yielding pump tube is formed as a loop or as an eyelet having an "Ω" shape.

[0055] In a 19th embodiment, which may be used in conjunction with any other embodiments described herein, the casing comprises a first pump port connected to or connectable to the first end of the yielding pump tube and in liquid communication with the first compartment.

[0056] In the 20th embodiment according to embodiment 19, the casing includes a second pump port connected to or connectable to the second end of the yielding pump tube and in liquid communication with the second compartment.

[0057] In the 21st embodiment according to embodiments 19 and 20, the first pump port and the second pump port are spread apart from each other and away from the casing.

[0058] In a 22nd embodiment, which may be used in conjunction with any other embodiments described herein, the casing comprises a plurality of ports connected to or connectable to the first end of each line tube.

[0059] In the previous embodiment 22 and embodiment 6-3 of the 22nd embodiment, the first pump port, the second pump port and the plurality of ports protrude from the respective sides of the casing, and optionally, each of the first pump port, the second pump port and the plurality of ports is shaped like a hollow cylinder, and optionally, the hollow cylinders of the plurality of ports are parallel to each other.

[0060] In a 22nd third embodiment, which may be used in conjunction with any other embodiments described herein, the casing comprises a patient port connected to or connectable to the first end of the patient line tube and in fluid communication with the second compartment.

[0061] In the 23rd embodiment according to aspect 22-3, the patient port may comprise a valve or part of a valve, i.e., a patient valve, or alternatively, a clamp of the cyclorama may be coupled to the patient tube so as to clamp the tube.

[0062] In the 24th embodiment according to aspect 22, part 3 or 23, at least one patient port has a seat for at least partially accommodating each occluding element of the cyclorama.

[0063] In the 25th embodiment according to embodiment 24, when used in conjunction with embodiment 23, the occlusion element of the cyclorama is part of the patient valve.

[0064] In embodiment 23, or in embodiment 24 or 25 when used in conjunction with embodiment 23, the patient line tube is in fluid communication with the second compartment when the valve of the patient port is open, and when the valve of the patient port is closed, fluid communication between the patient line tube and the second compartment is prevented.

[0065] In a 27th embodiment, which may be used in conjunction with any other embodiments described herein, the casing comprises at least one liquid port connected to or connectable to the first end of at least one liquid line tube and having liquid communication with a first compartment or a second compartment.

[0066] In the 28th embodiment according to embodiment 27, at least one liquid port may comprise a valve or part of a valve, i.e., a liquid valve, or alternatively, a clamp of the cyclorama may be coupled to the liquid line tube so as to clamp the tube.

[0067] In the 29th embodiment according to embodiment 27 or 28, at least one liquid port has a seat for at least partially accommodating each of the occluding elements of the cyclorama.

[0068] In the 30th embodiment according to embodiment 29, when used in conjunction with embodiment 28, the occluding element of the cyclorama is part of the liquid valve.

[0069] In embodiment 28, or in embodiment 29 or 30 when used in conjunction with embodiment 28, at least one liquid line tube is in liquid communication with the first or second compartment when the valve of at least one liquid port is open, and liquid communication between the at least one liquid line tube and the first or second compartment is prevented when the valve of at least one liquid port is closed.

[0070] In a 32nd embodiment according to any of embodiments 27 to 31, used in conjunction with any of embodiments 8 to 11, at least one liquid port comprises at least one dialysate port connected to the first end of at least one dialysate line tube, and optionally, at least one liquid port comprises a first dialysate port connected to the first end of a first dialysate line tube and a second dialysate port connected to the first end of a second dialysate line tube.

[0071] In the 33rd embodiment according to embodiment 32, the second end of the first dialysate line tube is connected to the first supply bag, and the second end of the second dialysate line tube is connected to the second supply bag.

[0072] In the 34th embodiment according to embodiment 32 or 33, at least one dialysate port comprises a valve or part of a valve, i.e., a dialysate valve, and optionally a first dialysate valve and a second dialysate valve.

[0073] In the 35th embodiment according to any of embodiments 32 to 34, at least one dialysate port has a seat for at least partially accommodating each occluding element of the cyclorama.

[0074] In the 36th embodiment according to embodiment 35, when used in conjunction with embodiment 34, the occlusion element of the cyclorama is part of the dialysis valve.

[0075] In embodiment 34, or embodiment 37 according to embodiment 35 or 36 when used in conjunction with embodiment 34, at least one dialysate line tube is in liquid communication with the first compartment or the second compartment when the valve of at least one dialysate port is open, and liquid communication between at least one dialysate line tube and the first compartment or the second compartment is prevented when the valve of at least one dialysate port is closed.

[0076] In a 38th embodiment according to any of embodiments 27 to 31, when used in conjunction with any of embodiments 12 to 14, at least one liquid port comprises a heater port connected to the first end of the heater line tube.

[0077] In the 39th embodiment according to embodiment 38, the heater port comprises a valve or a part of a valve, i.e., a heater valve.

[0078] In the 40th embodiment according to aspect 38 or 39, the heater port has a seat for at least partially accommodating each of the occluding elements of the cyclorama.

[0079] In the 41st embodiment according to embodiment 40, when used in conjunction with embodiment 39, the occluding element of the cyclorama is part of the heater valve.

[0080] In embodiment 39, or in embodiment 40 or 41 as used in conjunction with embodiment 39, the heater line tube is in liquid communication with the first compartment when the heater port valve is open, and liquid communication between the heater line tube and the first compartment is prevented when the heater port valve is closed.

[0081] In a 43rd embodiment according to any one of embodiments 27 to 31 when used in conjunction with embodiment 15 or 16, at least one liquid port comprises a drain port connected to the first end of a drain liquid line tube, and optionally, at least one liquid port comprises an auxiliary drain port connected to the first end of an auxiliary drain liquid line tube.

[0082] In the 44th embodiment according to embodiment 43, the drain port comprises a valve or part of a valve, i.e., a drain valve.

[0083] In the 45th embodiment according to aspect 43 or 44, the drain port has a seat for at least partially accommodating each of the occluding elements of the cyclorama.

[0084] In the 46th embodiment according to embodiment 45, when used in conjunction with embodiment 44, the occluding element of the cyclorama is part of the drain valve.

[0085] In embodiment 44, or embodiment 47 according to embodiment 45 or 46 when used in conjunction with embodiment 44, the drain line tube is in liquid communication with the first compartment when the valve of the drain port is open, and liquid communication between the drain line tube and the first compartment is prevented when the valve of the drain port is closed.

[0086] In the 48th embodiment according to embodiment 12, the casing comprises a first compartment, a second compartment, and a bypass channel that communicates with a heater line tube and liquid.

[0087] In the 48th-2 embodiment according to aspect 48, the bypass channel is at least partially defined by a cover bonded to the outer surface of the casing, optionally to the front surface of the casing.

[0088] In the 49th embodiment according to embodiment 48, the second compartment includes a bypass channel and a bypass port that communicates with a liquid.

[0089] In the 50th embodiment according to embodiment 49, the bypass port comprises each valve or part of a valve, i.e., a bypass valve.

[0090] In the 51st embodiment according to aspect 49 or 50, the bypass port has a seat for at least partially accommodating each of the occluding elements of the cyclorama.

[0091] In the 52nd embodiment according to embodiment 51, the occluding element of the cyclorama is part of the bypass valve.

[0092] In embodiment 50, or in embodiment 53 according to embodiment 51 or 52 when used in conjunction with embodiment 50, the heater line tube is in liquid communication with the second compartment when the bypass port valve is open, and liquid communication between the heater line tube and the second compartment is prevented when the bypass port valve is closed.

[0093] In a 54th embodiment, which may be used in conjunction with any other embodiments described herein, the first compartment is a first elongated passageway.

[0094] In the 55th embodiment according to embodiment 54, the first compartment extends between at least one of the liquid line tubes and the first end of the yielding pump tube.

[0095] In the 56th embodiment according to aspect 54 or 55, the first elongated passage is substantially U-shaped.

[0096] In the 57th embodiment according to any one of embodiments 54 to 56, the first end of at least one liquid line tube and the first end of a drain liquid line tube are arranged sequentially along a first elongated passage.

[0097] In a 58th embodiment, which may be used in conjunction with any other embodiments described herein, when the assembly is properly mounted to the cyclorama, the first end of at least one fluid line tube and the first end of the drain fluid line tube are positioned vertically.

[0098] In the 59th embodiment, according to any of embodiments 54 to 56 when used in conjunction with embodiments 10 to 16, the first end of the heater line tube, the first end of the drain fluid line tube, and optionally the first ends of a plurality of dialysate line tubes are also arranged sequentially along the first elongated passage, optionally along the longest extension of the U-shaped first elongated passage.

[0099] In the 60th embodiment according to embodiments 1 to 16, when the assembly is properly mounted to the cyclorama, the drain line tube is positioned above the patient line tube and optionally below the heater bag tube and the multiple dialysate line tubes, or alternatively, when the assembly is properly mounted to the cyclorama, the drain line tube is positioned above the patient line tube, the heater bag tube and the multiple dialysate line tubes, optionally, when the manifold assembly is properly mounted to the cyclorama, the drain line tube is positioned close to the top of the casing, and optionally, when the manifold assembly is properly mounted to the cyclorama, the patient line tube is positioned close to the bottom of the casing.

[0100] In embodiment 56, or embodiment 57 when used in conjunction with embodiment 56, the first end of the yielding pump tube is connected to the end of a U-shaped elongated passage.

[0101] In embodiment 56, or embodiment 57 when used in conjunction with embodiment 56, the 62nd embodiment, the second compartment is partially enclosed by a U-shaped, elongated passageway.

[0102] In the 63rd embodiment according to aspect 5, a plurality of expansion chambers are defined in the second compartment.

[0103] In the 64th embodiment according to aspect 63, at least two, and optionally three, expansion chambers are defined in the second compartment.

[0104] In a 65th embodiment, which may be used in conjunction with any other embodiments described herein, the internal volume of a second compartment having at least one expansion chamber is greater than the internal volume of the first compartment.

[0105] In a 66th embodiment, which may be used in conjunction with any other embodiments described herein, the internal volume of the second compartment is 50 cm³. 3 and 60cm 3Between them, optionally, 54cm 3 and 57cm 3 It is between these two points.

[0106] In a 67th embodiment, which may be used in conjunction with any other embodiments described herein, the internal volume of the first compartment is 8 cm². 3 and 20cm 3 Between them, optionally, 14cm 3 and 18cm 3 It is between these two points.

[0107] In the 68th embodiment according to embodiment 63 or 64, when used in conjunction with any of embodiments 54 to 57, the second compartment comprises a partition wall defining at least one expansion chamber and a second elongated passage in liquid communication.

[0108] In the 69th embodiment according to embodiment 68, the second elongated passage has a first end connected to the second end of the yielding pump tube and a second end that is in liquid communication with at least one expansion chamber.

[0109] In the 70th embodiment according to aspect 68 or 69, the second compartment comprises a main central section separated from a second elongated passageway by a partition wall.

[0110] In the 71st embodiment according to embodiment 70, at least one expansion chamber is defined in the main central part.

[0111] In the 72nd embodiment according to aspect 5, the casing comprises at least one recess / projection defining at least one expansion chamber, the at least one expansion chamber having a depth greater than the depth of the rest of the second compartment, and optionally, the recess / projection protrudes from the front of the casing.

[0112] In the 73rd embodiment according to embodiment 72, the outer shape of the recess / protrusion is configured so that it can be grasped by one of the user's hands.

[0113] In a 74th embodiment, which may be used in conjunction with any other embodiments described herein, the casing has an external flat surface for interface with at least one level sensor of the Cycla and optionally two level sensors of the Cycla.

[0114] In the 75th embodiment according to aspect 74, at least one level sensor is a capacitive sensor.

[0115] In the 76th embodiment according to aspect 74 or 75, at least one level sensor is configured to be located outside the casing.

[0116] In the 77th embodiment according to any one of embodiments 74 to 76, when the assembly is properly mounted on the cyclorama, the two level sensors are positioned above and below each other.

[0117] In a 78th embodiment, which may be used in conjunction with any other embodiments described herein, the casing has through-holes, which are optionally configured to engage with retaining elements of the cyclora, and which are optionally located on the front panel of the cyclora.

[0118] In the 79th embodiment according to embodiment 78, a plurality of expansion chambers and / or recesses / projections are defined in a second compartment, and an opening is located between two of the plurality of expansion chambers and / or recesses / projections.

[0119] In an 80th embodiment, which may be used in conjunction with any other embodiments described herein, when the assembly is properly mounted to the cyclorama, the upper part of the second compartment defines an air buffer capacity, which optionally communicates with the cyclorama's pressure transducer and / or air pump.

[0120] In the 81st embodiment according to embodiment 80, the casing includes a permeable membrane configured to communicate the pressure transducer and / or air pump of the cyclor with the upper part of the second compartment and / or the air buffer capacity when the manifold assembly is properly mounted to the cyclor.

[0121] In the 82nd embodiment according to embodiment 81, the breathable membrane is welded or bonded to the rigid shell of the casing.

[0122] In the 83rd embodiment according to embodiment 82, the breathable membrane is joined to the end of the hole in the rigid shell.

[0123] In the 84th embodiment according to embodiment 82, a rigid frame supports a breathable membrane, optionally the breathable membrane is joined to the rigid frame, the rigid frame is joined to the end of a hole in the rigid shell, and optionally the hole in the casing is formed on the front surface of the casing.

[0124] In the 85th embodiment according to any of embodiments 81 to 84, the permeable film formation is hydrophobic.

[0125] In an 86th embodiment, which may be used in conjunction with any other embodiments described herein, the casing comprises a rigid shell and at least one flexible membrane.

[0126] In the 87th embodiment according to embodiment 86, the rigid shell is made of rigid plastic, optionally molded rigid plastic.

[0127] In the 88th embodiment according to aspect 86 or 87, at least one flexible film is made of a plastic sheet, optionally a polyvinyl chloride sheet.

[0128] In the 89th embodiment according to any of embodiments 86 to 88, at least one soft film is welded or bonded to the rigid shell.

[0129] In the 90th embodiment according to any of embodiments 86 to 89, the rigid shell defines the front and side of the casing, and at least one soft membrane is the rear of the casing, and optionally, an area of ​​at least one soft membrane is configured to be coupled to a displacement sensor of the cyclor when the assembly is properly mounted to the cyclor, optionally, the area faces a zone of the first compartment, and optionally, the area is at the elbow of a substantially U-shaped first elongated passage.

[0130] In the 91st embodiment according to any of embodiments 86 to 89, when used in conjunction with embodiments 24 and 29, at least one soft membrane faces the seat of at least one fluid port and patient port, and the soft membrane is configured to deform by the occlusion element of the cyclorama when the occlusion element is at least partially housed in the seat, thereby closing the patient port and / or fluid port.

[0131] In the 92nd embodiment, according to any of embodiments 86 to 89 when used in conjunction with embodiment 51, at least one soft membrane faces the seat of the bypass port and is configured to be deformed by the closure element of the cyclorama when the closure element is at least partially housed in the seat, thereby closing the bypass port.

[0132] In a 93rd embodiment, which may be used in conjunction with any other embodiments described herein, the peritoneal dialysis apparatus comprises a cyclometer.

[0133] In the 94th embodiment according to embodiment 93, the cyclorama comprises a peristaltic pump, optionally a roller peristaltic pump, the peristaltic pump optionally comprising one or more pressing elements, optionally one or more pressing rollers, and optionally the peristaltic pump comprising two pressing elements arranged at an angle of 180°.

[0134] In the 95th embodiment according to embodiment 94, the yielding pump tube is configured to be partially arranged or partially arranged around the rotor of the peristaltic pump.

[0135] In the 96th embodiment according to any of embodiments 93 to 95, the cyclorama comprises at least one level sensor, optionally two level sensors, and optionally the cyclorama comprises at least one displacement sensor.

[0136] In a 97th embodiment according to any of embodiments 93 to 96, when used in conjunction with embodiment 13 or 14, the cyclorama comprises a heater, and the heater bag is configured to be coupled to the heater.

[0137] In a 98th embodiment according to any of embodiments 93 to 97, when used in conjunction with embodiments 22 and 27, the cyclorama comprises a plurality of occlusion elements, each occlusion element configured to be at least partially housed in the respective seats of a fluid port and a patient port, or, instead, the fluid port and patient port have neither seat, and each occlusion element is a clamp configured to hold one of the fluid line tube or patient tube.

[0138] In the 98th embodiment according to embodiment 99, when used in conjunction with any of embodiments 86 to 92, each occlusion element defines a valve together with a soft membrane portion and its respective seat, or each clamp defines a pinch valve together with a portion of the liquid line tube, optionally a heater valve for a heater port, a bypass valve for a bypass port, a first dialysis valve for a first dialysis port, a second dialysis valve for a second dialysis port, a drain valve for a drain port, a patient valve for a patient port, and optionally an auxiliary drain valve for an auxiliary drain port.

[0139] In a 100th embodiment according to any of embodiments 93 to 97, when used in conjunction with any of embodiments 81 to 85, the cyclorama comprises a pressure transducer and / or air pump configured to communicate with a permeable membrane and / or air buffer capacity of the casing.

[0140] In the 101st embodiment according to embodiment 100, the cyclorama comprises an air conduit that communicates with a pressure transducer and / or an air pump, the air conduit having a coupling end configured to be coupled to a permeable membrane of the casing.

[0141] In embodiment 95 or 95, or in embodiment 96 to 101 as used in embodiment 94 or 95, the cyclorama comprises a box having a front panel, the rotor of a peristaltic pump located on the front panel.

[0142] In a 103rd embodiment according to embodiment 102, the cyclorama includes a lid that is movable between a closed position in which the lid covers the front panel and an open position in which the lid is separated from the front panel, allowing access to the front panel.

[0143] In a 104th embodiment according to embodiment 103, the front panel and / or lid is molded to receive at least a portion of the manifold assembly, and optionally the front panel is molded to receive and hold the manifold assembly, and optionally the front panel comprises a retaining element configured to be coupled to the manifold assembly and optionally hold the manifold assembly in a removable manner.

[0144] In the 105th embodiment according to aspect 103 or 104, once the manifold assembly is properly mounted to the cyclorama, the manifold assembly is closed between the front panel and the cover.

[0145] In a 106th embodiment according to any of embodiments 103 to 105 when used in conjunction with embodiment 101, at least the coupling end of the air conduit is attached to the lid or front panel, and when the manifold assembly is properly mounted to the cyclorama, the coupling end is coupled to the permeable membrane of the casing.

[0146] In a 107th embodiment according to any of embodiments 103 to 106, when used in conjunction with embodiment 96, at least one level sensor is mounted on the front panel or on the lid.

[0147] In a 108th embodiment according to any of embodiments 103 to 106, when used in conjunction with embodiment 24 or 29, the occlusion element is mounted on the front panel or on the lid.

[0148] In a 109th embodiment according to one or more embodiments of 93 to 108, the cyclorama comprises a control unit, a motor for a peristaltic pump, and an actuator for an occlusion element, the control unit being operably connected to the motor, actuator, pressure transducer and / or air pump, and at least one level sensor and optionally a displacement sensor, and the control unit being configured / programmed to control the operation of the peritoneal dialysis machine.

[0149] In the 110th embodiment according to Embodiment 3 or Embodiment 109, when used in conjunction with Embodiment 99, the method includes the following steps, or the control unit is configured to perform the following steps: opening a first dialysis valve and a patient valve; closing a heater valve, a bypass valve, a second dialysis valve and a drain valve; and rotating a peristaltic pump in a first rotational direction to pump the liquid from the first compartment to the second compartment in order to move the dialysate from the first supply bag to the patient.

[0150] In an embodiment 111 by embodiment 3 or embodiment 109, used in conjunction with embodiment 99, the method includes the following steps, or the control unit is configured to perform the following steps: opening a first dialysis valve and a bypass valve; closing a heater valve, a second dialysis valve, a drain valve and a patient valve; and rotating a peristaltic pump in a first rotational direction to pump the liquid from the first compartment to the second compartment in order to move the dialysate from the first supply bag to the heater bag.

[0151] In the 112th embodiment according to Embodiment 3 or Embodiment 109, when used in conjunction with Embodiment 99, the method comprises the following steps, or the control unit is configured to perform the following steps: opening the heater valve and the first dialysis valve; closing the bypass valve, the second dialysis valve, the drain valve and the patient valve; and rotating the peristaltic pump in the second rotational direction to pump the fluid from the second compartment to the first compartment in order to move the dialysate from the first supply bag to the heater bag.

[0152] In the 113th embodiment according to Embodiment 3 or Embodiment 109, when used in conjunction with Embodiment 99, the method comprises the following steps, or the control unit is configured to perform the following steps: opening the heater valve and the patient valve; closing the bypass valve, the first dialysis valve, the second dialysis valve and the drain valve; and rotating the peristaltic pump in a first rotational direction to pump the fluid from the first compartment to the second compartment in order to move the heated dialysate from the heater bag to the patient.

[0153] In the 114th embodiment according to Embodiment 3 or Embodiment 109, when used in conjunction with Embodiment 99, the method comprises the following steps, or the control unit is configured to perform the following steps: opening the drain valve and the patient valve; closing the bypass valve, the first dialysis valve, and the second dialysis valve; and rotating the peristaltic pump in a second rotational direction to pump fluid from the second compartment to the first compartment in order to move the used dialysate from the patient to the drain.

[0154] In a 115th embodiment according to Embodiment 3 or Embodiment 109, when used in conjunction with Embodiment 99, the method includes the following steps, or the control unit is configured to perform the following steps: opening the bypass valve and the drain valve; closing the heater valve, patient valve, first dialysis valve, and second dialysis valve; rotating the peristaltic pump in a second rotational direction to deliver priming fluid from the second compartment to the first compartment and from the heater bag to the drain; and performing a preparation step.

[0155] In the 116th embodiment according to Embodiment 3 or Embodiment 109, when used in conjunction with Embodiment 99, the method comprises the following steps, or the control unit is configured to perform the following steps: opening the heater valve and auxiliary drain valve; closing the patient valve, first dialysis valve, second dialysis valve, and drain valve; rotating the peristaltic pump in a first rotational direction to deliver priming fluid from the first compartment to the second compartment and from the heater bag to the drain; and performing a preparation step.

[0156] In the 117th embodiment according to Embodiment 3 or Embodiment 109, when used in conjunction with Embodiment 99, the method comprises the following steps, or the control unit is configured to perform the following steps: opening a first dialysis valve; closing the bypass valve, heater valve, patient valve, second dialysis valve and drain valve; and rotating the peristaltic pump in a first rotational direction to deliver priming fluid from the first compartment to the second compartment and from the first supply bag to the expansion chamber in order to perform a preparation step.

[0157] In the 118th embodiment according to Embodiment 3 or Embodiment 109, when used in conjunction with Embodiment 99, the method comprises the following steps, or the control unit is configured to perform the following steps: opening the drain valve; closing the bypass valve, heater valve, patient valve, second dialysis valve and first dialysis valve; and rotating the peristaltic pump in a second rotational direction to deliver priming fluid from the second compartment to the first compartment and from the expansion chamber to the drain in order to perform a preparation step.

[0158] In the 119th embodiment according to Embodiment 3 or Embodiment 109, when used in conjunction with Embodiment 99, the method comprises the following steps, or the control unit is configured to perform the following steps: opening the second dialysis valve; closing the bypass valve, heater valve, patient valve, drain valve and first dialysis valve; and rotating the peristaltic pump in a first rotational direction to deliver priming fluid from the first compartment to the second compartment and from the second supply bag to the expansion chamber in order to perform the preparation steps.

[0159] In the 120th embodiment according to Embodiment 3 or Embodiment 109, when used in conjunction with Embodiment 99, the method includes the following steps, or the control unit is configured to perform the following steps: opening the first dialysis valve and drain valve; closing the bypass valve, heater valve, patient valve, and second dialysis valve; rotating the peristaltic pump in a second rotational direction to deliver priming fluid from the second compartment to the first compartment and from the first supply bag to the drain; and performing a preparation step.

[0160] In the 121st embodiment according to Embodiment 3 or Embodiment 109, when used in conjunction with Embodiment 99, the method includes the following steps, or the control unit is configured to perform the following steps: opening the second dialysis valve and drain valve; closing the bypass valve, heater valve, patient valve, and first dialysis valve; rotating the peristaltic pump in the second rotational direction to deliver priming fluid from the second compartment to the first compartment and from the second supply bag to the drain; and performing a preparation step.

[0161] In the 122nd embodiment according to Embodiment 3 or Embodiment 109, when used in conjunction with Embodiment 99, the method includes the following steps, or the control unit is configured to perform the following steps: opening the heater valve and the patient valve; closing the bypass valve, the first dialysis valve, and the second dialysis valve; rotating the peristaltic pump in a first rotational direction to deliver priming fluid from the first compartment to the second compartment and from the heater bag to the patient; and performing a preparation step.

[0162] In the 123rd embodiment according to Embodiment 3 or Embodiment 109, when used in conjunction with Embodiment 99, the method includes the following steps, or the control unit is configured to perform the following steps: opening the heater valve, patient valve, bypass valve, first dialysis valve, drain valve, and second dialysis valve; opening the yielding pump tubing; and performing a preparation step.

[0163] A 124th embodiment, which may be independent, relates to a manifold assembly for a dialysis machine, the manifold assembly comprising a casing comprising a rigid shell and at least one flexible membrane, wherein the rigid shell and flexible membrane define at least a first fluid passage, the rigid shell comprises at least one port having fluid communication with the first and second fluid passages, the at least one port having a seat, the at least one flexible membrane facing the seat of the at least one port, the seat being configured to at least partially accommodate each occlusion element of the dialysis machine.

[0164] A 125th aspect relates to a dialysis apparatus comprising a dialysis machine and a manifold assembly of aspect 124, wherein the manifold assembly is attached to or can be attached to the dialysis machine, the dialysis machine comprising at least one occlusion element, the occlusion elements facing a seat, between which a soft membrane is disposed when the manifold assembly is properly attached to the dialysis machine, optionally the dialysis apparatus is an apparatus for extracorporeal treatment of blood, optionally the apparatus for extracorporeal processing of blood comprising a blood treatment device, an extracorporeal blood circuit coupled to the blood treatment device, a blood pump, a pump section of the extracorporeal blood circuit configured to be coupled to the blood pump, optionally a therapeutic fluid circuit operably connected to the extracorporeal blood circuit and / or the blood processing device, optionally the therapeutic fluid circuit comprising a dialysis line connected to a fluid chamber of a treatment unit, optionally a fluid discharge line connected to a fluid chamber, optionally the therapeutic fluid circuit comprising an infusion circuit comprising one or more infusion lines for replacement fluid, the manifold assembly may be part of the extracorporeal blood circuit or the therapeutic fluid circuit.

[0165] In the 126th embodiment according to any of embodiments 24, 25, 29, 30, 35, 36, 40, 41, 45, 46, 51, 52, 91, 92, 98, 99, 108, 109 and 125, the closure element comprises a plunger and an actuator, the actuator configured to move between a retracted position in which the plunger is separated from the soft membrane and the port is open, and an advanced position in which the plunger is at least partially housed in the seat and the soft membrane is trapped between the plunger and the seat in order to close the port, optionally the actuator is a stepping motor or a linear actuator.

[0166] In the 127th embodiment according to aspect 126, the soft membrane is configured to deform by the plunger when the plunger is at least partially housed within the seat in order to close the port.

[0167] In the 128th embodiment according to embodiment 127, the seat comprises an end, optionally a circular end, and when the plunger is at least partially housed within the seat, the soft membrane is trapped between the plunger and the end.

[0168] In the 129th embodiment according to aspects 126, 127, or 128, the occlusion element comprises a membrane tensioner configured to counteract an expected negative pressure, which tends to raise the soft membrane away from its seat when the plunger returns to the retracted position, thereby keeping the port closed, and optionally the membrane tensioner is mechanical.

[0169] In the 130th embodiment according to embodiment 129, the membrane tensioner comprises a tension-applying plunger connected to an actuator or auxiliary actuator of a plunger, the actuator or auxiliary actuator configured to move between a retracted position in which the tension-applying plunger is separated from the soft membrane and an advanced position in which the tension-applying plunger engages with the soft membrane at a location other than the seat, optionally at a location other than the end, moves the soft membrane away from the seat, and extends the soft membrane above the seat, optionally the tension-applying plunger is arranged around the plunger, optionally the tension-applying plunger has a substantially cylindrical wall, and optionally the tension-applying plunger is coaxial with the plunger.

[0170] In the 131st embodiment according to embodiment 130, the tension-applying plunger comprises at least one arched wall, optionally a plurality of arched walls, wherein at least one window is defined by the arched walls, or a plurality of windows are defined between the arched walls, and optionally the tension-applying plunger comprises two arched walls and two windows.

[0171] In the 132nd embodiment according to embodiment 130 or 131, when the plunger is in the forward position, the tension-applying plunger is in the retracted position, and when the plunger is in the retracted position, the tension-applying plunger is in the forward position.

[0172] In the 133rd embodiment according to embodiment 130, 131, or 132, the occlusion element comprises a shaft having a distal end for supporting a plunger, the tension-applying plunger being mounted on the shaft and movable axially along the shaft, optionally the tension-applying plunger being coaxial with the shaft, and optionally an actuator being connected to the shaft for moving the shaft.

[0173] In a 134th embodiment according to any of embodiments 130 to 133, a location other than the end comprises an auxiliary end spaced apart from the end, which is raised relative to the end and partially extends around the seat in order to keep the port open when the tension-applying plunger is in the forward position, and optionally the auxiliary end is arched or comprises at least one arched portion, optionally a plurality of arched portions, wherein the arched portions define at least one radial opening, or a plurality of radial openings define between the arched portions.

[0174] In the 135th embodiment according to any of embodiments 130 to 134, the port comprises a molded member protruding from the bottom surface of the rigid shell, and the seat is formed within the molded member.

[0175] In the 136th embodiment according to embodiment 135, the molded member comprises an end and an auxiliary end.

[0176] In the 137th embodiment according to aspect 135 or 136, the molded member is cylindrical or substantially cylindrical.

[0177] In the 138th embodiment according to any of embodiments 135 to 137, the molded member defines a central cavity, and the end defines the upper part of the central cavity.

[0178] In the 139th embodiment according to embodiment 134, when the tension-applying plunger is in the forward position, the wall of the tension-applying plunger is positioned close to the auxiliary end.

[0179] In the 140th embodiment according to embodiment 135, when the tension-applying plunger is in the forward position, the molding member is positioned at least partially inside the tension-applying plunger, and the wall of the tension-applying plunger surrounds the auxiliary end.

[0180] In the 141st embodiment according to embodiments 131 and 134, when the tension-applying plunger is in the forward position, at least one arched wall of the tension-applying plunger is positioned close to at least one arched portion of the auxiliary end such that at least one window radially faces at least one radial opening, and optionally, each arched wall of the tension-applying plunger is positioned radially outward of each arched portion of the auxiliary end such that each window radially faces its respective radial opening.

[0181] In the 142nd embodiment according to embodiments 131 and 134, the number of arch-shaped sections and arch-shaped walls is equal.

[0182] In a 143rd embodiment according to any of embodiments 130 to 142, the occlusion element includes a reverse mechanism connecting a tension-applying plunger and a plunger, the reverse mechanism being configured to move the plunger in the opposite direction to the direction of movement of the tension-applying plunger when the plunger or tension-applying plunger is moved by an actuator.

[0183] In the 144th embodiment according to embodiment 143, the reverse mechanism comprises a plunger, a tension-applying plunger, and a rocker lever hinged to a stationary part of a dialysis machine or cyclorama, such that when the shaft is moved axially in a second direction opposite to the first direction, the tension-applying plunger moves axially in the first direction, and optionally the rocker lever is hinged to the shaft of the plunger.

[0184] In the 145th embodiment according to embodiment 144, the first end of the rocker lever is hinged to a plunger, optionally to a shaft, the second end of the rocker lever is hinged to a tension-applying plunger, and the central part of the rocker lever is hinged to a stationary part.

[0185] In the 146th embodiment according to embodiment 143, the reverse mechanism includes a threaded joint between the shaft and the tension-applying plunger such that when the shaft is moved axially in a second direction opposite to the first direction, the tension plunger moves axially in the first direction.

[0186] In the 147th embodiment according to embodiment 146, the motor comprises a rotatable shaft, the rotatable shaft being coupled to the shaft of a plunger via a threaded coupling, the threaded coupling between the shaft and the tension-applying plunger being left-hand threaded, and the threaded coupling between the rotatable shaft and the shaft being right-hand threaded (or vice versa).

[0187] In the 148th embodiment according to any of embodiments 126 to 147, the occlusion element comprises a damping and / or elastic element coupled to the plunger, optionally the damping and / or elastic element being positioned between the distal end of a shaft supporting the plunger and the plunger.

[0188] The 149th aspect relates to a method for calibrating a peristaltic pump in a dialysis machine, optionally in a peritoneal dialysis machine or a device for extracorporeal processing of blood, wherein the dialysis machine comprises a dialysis machine or cyclorama according to one or more of the preceding or succeeding aspects, and a manifold assembly according to one or more of the preceding or succeeding aspects.

[0189] The 150th aspect relates to a dialysis machine, optionally a peritoneal dialysis machine, or a device for extracorporeal processing of blood, comprising a dialysis machine or cyclorama according to one or more of the preceding or subsequent aspects, and a manifold assembly according to one or more of the preceding or subsequent aspects, wherein the control unit of the dialysis machine or cyclorama is operably connected to at least a peristaltic pump and a pressure transducer, and is configured and / or programmed to calibrate the peristaltic pump.

[0190] In the 151st embodiment according to aspect 149 or 150, the control unit performs the following steps: i. Rotating the peristaltic pump by a predetermined number of rotations to send liquid from the liquid supply source into the second compartment, raising the liquid level in the second compartment, and compressing the air in the air buffer capacity, ii. Measuring the pressure within the air buffer volume, iii. Calculate the change in liquid volume in the second compartment due to the rotation of the peristaltic pump from the measured pressure of air in the air buffer volume, iv. Calculating the stroke fluid volume of the peristaltic pump from the change in fluid volume and a predetermined rotation, It is configured and / or programmed to perform [something].

[0191] In the 152nd embodiment according to embodiment 151, rotating the peristaltic pump by a predetermined number of rotations includes rotating the peristaltic pump by a plurality of rotations or a fraction thereof such that the pressing element of the peristaltic pump or one of the plurality of pressing elements of the peristaltic pump is in the same predetermined position at the start and end of the rotation.

[0192] In the 153rd embodiment according to embodiment 152, the peristaltic pump includes an encoder operably connected to a control unit to detect the position and movement of one or more pressing elements of the peristaltic pump.

[0193] In the 154th embodiment according to embodiment 153, the control unit is configured and / or programmed to detect a predetermined position via an encoder.

[0194] In the 155th embodiment according to any of embodiments 151 to 154, the peristaltic pump comprises two pressing elements arranged at an angle of 180°, wherein a predetermined rotation includes "n" half rotations of the peristaltic pump, where "n" is optionally an integer between 5 and 10, and optionally the rotational speed of the peristaltic pump is between 3 rpm and 8 rpm.

[0195] In the 156th embodiment according to any of embodiments 150 to 155, the yielding pump tube is formed as a loop having a curved section and two straight sections, and the pressing element presses the curved section during rotation.

[0196] In the 157th embodiment according to embodiment 156 as described in embodiment 152, the predetermined position is the portion between the curved portion and one of the two straight portions, or is close to the portion between the curved portion and one of the two straight portions.

[0197] In the 158th embodiment according to any of embodiments 151 to 157, measuring the pressure of air in an air buffer volume includes measuring the initial pressure before air compression and measuring the final pressure after air compression.

[0198] In the 159th embodiment according to embodiment 158, the initial pressure is approximately 0 mmHg.

[0199] In the 160th embodiment according to aspect 158 ​​or 159, the final pressure is approximately 400 mmHg.

[0200] In the 161st embodiment according to any of embodiments 151 to 160, the liquid level starts rising from a first level, and at the end of a predetermined rotation, the liquid is at a second level.

[0201] In the 162nd embodiment according to embodiment 161, which is based on any of embodiments 158 to 159, the change in liquid volume is calculated according to the initial amount of air above the first level, the initial pressure and the final pressure.

[0202] In the 163rd embodiment according to embodiments 162 and 155, the stroke fluid volume is the ratio between the change in fluid volume and the number of half-rotations of the peristaltic pump included in a given rotation.

[0203] In any of embodiments 161 to 163 and in the 164th embodiment according to embodiment 96, at least one level sensor comprises a low-level sensor, and a first level of liquid is obtained by rotating the peristaltic pump until a low liquid level is detected via the low-level sensor, and further rotating the peristaltic pump by a predetermined angle to deliver an additional amount of liquid above the low liquid level in the second compartment.

[0204] In two embodiments of the 164 according to embodiment 164, rotating the peristaltic pump until a low liquid level is detected includes: rotating the peristaltic pump in a first rotational direction to pump liquid from the first compartment to the second compartment until a low liquid level is first detected and the peristaltic pump is stopped; rotating the peristaltic pump in a second rotational direction to bring the liquid level below the low liquid level and stop the peristaltic pump; and rotating the peristaltic pump again in the first rotational direction to reach the low liquid level again and continuing to rotate the peristaltic pump to pump an additional amount of liquid.

[0205] In embodiments 164 and 165 according to embodiments 152, a predetermined position of the pressing element is the end position of a further rotation of a predetermined angle, and optionally, a control unit is configured and / or programmed to set the predetermined position of the pressing element as the end position of a further rotation of a predetermined angle, and the peristaltic pump starts from the predetermined position of the pressing element corresponding to the first level and rotates by a predetermined number of rotations, and optionally, an air valve connected to an air buffer capacity opens before reaching the predetermined position, and the air valve closes for subsequent compression once the predetermined position is reached.

[0206] In the 166th embodiment according to aspect 164 or 165, the first level is the level reached at the end of a further rotation of a predetermined angle.

[0207] In the 167th embodiment according to any of embodiments 164 to 166, the predetermined angle is between 90° and 120°.

[0208] In the 168th embodiment according to any of embodiments 164 to 167, the first volume is defined in a second compartment below the low-level sensor, and optionally, the first volume is between 5 ml and 15 ml.

[0209] In embodiments 164 to 168 and the 169th embodiment according to either embodiment 162 or 163, the initial air volume is the difference between the air volume above the low liquid level and the amount of liquid added.

[0210] In embodiment 165, or in embodiment 170 according to any one of embodiments 166 to 169 as of embodiment 165, at least one level sensor comprises a high-level sensor, and a high liquid level is detected via the high-level sensor, and the rotation of the peristaltic pump is stopped when the pressing element is in a predetermined position after first detecting a high liquid level.

[0211] In the 171st embodiment according to aspect 170, the second quantity is defined in a second compartment between the low-level sensor and the high-level sensor.

[0212] In the 172nd embodiment according to embodiment 171, the second volume is between 2 and 4 times the nominal stroke fluid volume of the peristaltic pump, and optionally between 15 ml and 25 ml.

[0213] In the 173rd embodiment according to embodiment 172, the third quantity is defined in the second compartment above the high-level sensor.

[0214] In the 174th embodiment according to embodiment 173, the third volume is between 10 ml and 20 ml.

[0215] In the 175th embodiment according to any of embodiments 170 to 174, the control unit is configured and / or programmed to perform the following steps: after stopping the rotation of the peristaltic pump, before obtaining the final pressure, wait for a stabilization period, continue measuring the pressure, and check for potential leaks.

[0216] In embodiment 150, or in embodiment 176 according to any one of embodiments 151 to 175 as of embodiment 150, the casing comprises a permeable membrane configured to communicate a pressure transducer with an air buffer volume.

[0217] In the 177th embodiment according to embodiment 176, the dialysis machine or cyclorama further comprises an auxiliary chamber that communicates with an air buffer volume and a pressure transducer via a permeable membrane.

[0218] In the 178th embodiment according to embodiment 177, the fourth volume of the auxiliary chamber is between 20 ml and 30 ml, and optionally the sum of the second, third, and fourth volumes is between 50 ml and 70 ml.

[0219] In the 179th embodiment according to any of embodiments 151 to 178, the stroke fluid volume calculation in steps i to iv is performed multiple times, optionally 2 to 5 times, in succession to determine the average stroke fluid volume.

[0220] At least one expansion chamber configured to attenuate pressure pulsations from the peristaltic pump reduces the peristaltic effect of the peristaltic pump with a positive effect on patient comfort.

[0221] The presence of an air buffer ensures the removal of potentially present air bubbles in the solution before administration to the patient.

[0222] The connection between the air buffer capacity and the pressure transducer has a contextual interface with an air pump that allows monitoring of the pressure value in a second compartment coupled to the patient line tube and can adjust the fluid level in the second compartment in response to feedback provided by a fluid level sensor.

[0223] The aforementioned flexible plastic sheet, which interfaces with the Cycla displacement sensor, allows for the detection of the possibility of extreme negative pressure values ​​occurring within the first compartment connected to the drain and heater bags.

[0224] The casing shape of the manifold assembly provides improved usability, featuring a "one-handed first handling step" for mounting the device to the cyclorama.

[0225] The overall design of the manifold assembly also features a user-friendly interface and compatibility with Cycra's hardware components.

[0226] The structure of the casing and occlusion element ports of a cyclometer or dialysis machine ensures the precise and regular closing and opening movements of the valve.

[0227] The yielding pump tubing, coupled to the peristaltic pump, along with the calibration of the assembly comprising the yielding pump tubing and the peristaltic pump, enables precise and simple control of fluid flow and enhanced monitoring of the effectiveness of dialysis treatment. [Brief explanation of the drawing]

[0228] [Figure 1] Figure 1 is a perspective view of one embodiment of the automated peritoneal dialysis device ("APD") of the present disclosure.

[0229] [Figure 2] Figure 2 is a front view of one embodiment for a manifold assembly of the APD device of the present disclosure.

[0230] [Figure 3] Figure 3 is a rear view of the manifold assembly shown in Figure 2, with some components removed to show the internal structure and others shown schematically.

[0231] [Figure 4] Figure 4 is a side view of the manifold assembly shown in Figure 2.

[0232] [Figure 5]Figure 5 is a schematic cross-sectional view of a portion of the side view shown in Figure 4.

[0233] [Figure 6] Figures 6A and 6B are schematic cross-sectional views of another part of the assembly along the section line VI-VI in Figure 3.

[0234] [Figure 7] Figure 7 is a schematic cross-sectional view of another part of the assembly along the cross-sectional line VII-VII in Figure 3.

[0235] [Figure 8] , [Figure 9] , [Figure 10] , [Figure 11] Figures 8 to 11 show rear views of Figure 3, illustrating the configuration of the manifold assembly and associated fluid flow paths.

[0236] [Figure 12] , [Figure 13] , [Figure 14] , [Figure 15] Figures 12 to 15 are flowcharts showing the configurations shown in Figures 8 to 11.

[0237] [Figure 16] Figure 16 is a rear view of another embodiment of the manifold assembly, in which some components have been removed to show the interior and some other components are shown schematicly.

[0238] [Figure 17] Figure 17 is a rear view of Figure 16, showing the configuration of each flow.

[0239] [Figure 18] Figure 18 is a flowchart showing the configuration of Figure 17.

[0240] [Figure 19]Figure 19 is a rear view of a further embodiment of the manifold assembly, in which some components have been removed to show the interior and some other components are shown schematicly.

[0241] [Figure 20] Figures 20A, 20B, and 20C show embodiments of the valve according to the embodiments of Figures 16, 17, and 18.

[0242] [Figure 21] Figures 21A to 21D show the operating steps of the valve in Figure 20A in cooperation with the Cycla element.

[0243] [Figure 22] Figure 22 shows an embodiment of the element shown in Figure 21A.

[0244] [Figure 22A] Figure 22A is a variation of the embodiment shown in Figure 22.

[0245] [Figure 23] Figure 23 shows another embodiment of the element in Figure 21A.

[0246] [Figure 24] Figure 24 shows the components of the element shown in Figure 22 or 23.

[0247] [Figure 25] Figure 25 is a schematic top view of the valve in Figure 20A and the component in Figure 24.

[0248] [Figure 26] Figure 26 shows the manifold assemblies of Figures 16 and 17 configured to perform the calibration method.

[0249] [Figure 27] Figure 27 shows the manifold assembly from Figure 26 and the liquid level in the manifold during calibration.

[0250] [Figure 28] Figure 28 is a chart illustrating the calibration method.

[0251] [Figure 29] Figure 29 is a flowchart showing the calibration method. [Modes for carrying out the invention]

[0252] Embodiment 1

[0253] Referring here to Figures 1 to 15, an embodiment of the peritoneal dialysis apparatus 1 (APD) comprises a cycla 2 and a manifold assembly 3 (Figures 2 and 3) for organizing tubing and performing many of the functions described herein.

[0254] The Cycla 2 comprises a box 4 housing all of the mechanical and electronic parts of the Cycla 2. The Cycla 2 includes an electronic control unit 5 (Figure 4), a roller peristaltic pump 6 (Figure 1), a plurality of occlusion elements 7, a first level or high level sensor 8, a second level or low level sensor 9, a pressure transducer 10, and an air pump 11 (circumstantially shown in Figure 4). The Cycla 2 may also include a heater, which is not shown.

[0255] The peristaltic pump shown in Figures 3 and 25 comprises two pressure rollers 6a arranged at an angle of 180° apart.

[0256] A motor for the peristaltic pump 6 (not shown) is housed in the box 4, and the rotor 12 of the peristaltic pump 6 is positioned on the front panel 13 of the box 4 (Figure 1).

[0257] Site 14 of the front panel 13 adjacent to the rotor 6 is configured to removably hold the manifold assembly 3 on the front panel 13. Site 14 may have a retaining element configured to couple with the manifold assembly 3, and / or the manifold assembly 3 may have a hook element configured to removably hook the disposable assembly 3 onto the front panel 13 of the cyclorama 2.

[0258] The occlusion elements 7 (Figure 4) protrude from the front panel at site 14. Each occlusion element 7 comprises a plunger 15 (Figures 6A and 6B) housed in a box 4 and moved by a respective actuator (not shown). The actuators are configured to move the plunger 15 between a retracted position (Figure 6A) and an advanced position (Figure 6B), as described herein.

[0259] The Cycra 2 includes a lid 16 (Figures 1 and 4) that is movable between a closed position in which the lid 16 covers the front panel 13 and an open position in which the lid 16 is separated from the front panel 13, allowing the user access to the front panel 13. In the embodiments of the accompanying drawings, the lid 16 is hinged to the box 4 and can rotate between the open and closed positions. For simplicity, elements belonging to the lid 16 that are detailed below are not shown in Figure 1.

[0260] When the manifold assembly 3 is properly mounted on site 14 of the Cycra 2 and the cover 16 is in the closed position, the manifold assembly 3 is closed between the front panel 13 and the cover 16.

[0261] The first level sensor 8 and the second level sensor 9 are mounted on the lid 16 and protrude from the side of the lid 16, which is configured to face the front panel 13 and / or manifold assembly 3 when the lid 16 is in the closed position (Figure 4). The level sensors 8 and 9 shown are capacitive sensors. In other embodiments, although not shown in the accompanying figures, the level sensors 8 and 9 may be ultrasonic sensors or other types of sensors and / or mounted on the front panel of the box 4.

[0262] An air conduit 17 is mounted on the lid 16 and includes a coupling end 18. The coupling end 18 is configured to face the manifold assembly 3 when the lid 16 is in the closed position (Figures 4 and 5), as described herein. The air conduit 17 is in air communication with a pressure transducer 10 and an air pump 11. The pressure transducer 10 and the air pump 11 may be installed on the lid 16 or in the box 4.

[0263] The control unit 5, schematically shown in Figure 4, is operably connected to the motor of the peristaltic pump 6, the actuator of the occlusion element 7, the pressure transducer 10 and the air pump 11, the first level sensor 8 and the second level sensor 9, the heater, and any other devices or sensors of the cyclorama 2, and is configured / programmed to control the operation of the peritoneal dialysis machine 1.

[0264] The control unit may also be connected to a display, keyboard, or touchscreen 100 configured to show the operating parameters of device 1 and / or to allow the user to set up device 1 (Figure 1).

[0265] The lid 16 and / or front panel 13 of box 4 may also include further elements, not shown, configured to manage and route the tubing of manifold assembly 3.

[0266] The manifold assembly 3 for the peritoneal dialysis device 1 includes a disposable casing 19 that comprises a rigid molded plastic rigid shell 20 made of, for example, a PETG (glycol-modified polyethylene terephthalate) polymer (Figs. 2, 3, and 4), and a plastic sheet 21 that is, for example, a polyvinyl chloride flexible sheet (Fig. 4). The rigid molded plastic rigid shell 20 defines the front and side surfaces of the casing 19, and the plastic sheet 21 forms the back surface of the casing 19 (Fig. 4).

[0267] The plastic rigid shell 20 has a substantially flat shape and includes internal partitions and recesses inside the casing 19. The partitions internally define a first compartment 22 and a second compartment 23 for unused dialysis fluid and used dialysis fluid (Fig. 3). The recesses internally define three expansion chambers 24a, 24b, 24c respectively, and externally define three protrusions 25a, 25b, 25c respectively on the front surface of the casing 19 (Figs. 2 and 3).

[0268] In a front view or a rear view, the plastic rigid shell 20 and the casing 19 have a substantially rectangular outer shape with two long sides and two short sides. When the casing 19 is properly attached to the cycler 2, the two long sides are vertical.

[0269] The first compartment 22 is defined by an outer partition 26 arranged on the peripheral boundary of the plastic rigid shell 20 and a first inner partition 27. Referring to the rear views of Figs. 3, 8, 9, 10, and 11, the first inner partition 27 has a first end connected to the outer partition 26 on the upper short side of the plastic rigid shell 20 and a second end connected to the outer partition 26 on the right long side of the plastic rigid shell 20.

[0270] The first inner partition 27 has a substantially U shape and extends substantially parallel to the left long side, the bottom short side, and the right long side of the plastic rigid shell 20. The first compartment 22 is a U-shaped first elongated passage.

[0271] The second compartment 23 is defined by the first inner partition 27 and by a part of the outer partition 26 that does not define the first compartment 22 such that the second compartment 23 is partially surrounded by the U-shaped first compartment 22.

[0272] A second inner partition 28 is disposed inside the second compartment 23 and forms a route within the second compartment 23. The second inner partition 28 has a first end connected to the first inner partition 27 at a position close to the first end of the first inner partition 27 and a second free end disposed at a position close to the lower right corner of the plastic rigid shell 20.

[0273] Referring to the rear views of FIGS. 3, 8, 9, 10, and 11, the second inner partition 28 has a substantially inverted L shape and extends substantially parallel to the upper short side surface and the right long side surface of the plastic rigid shell 20. Accordingly, the second compartment 23 includes an inverted L-shaped second elongated passage.

[0274] The long extension of the inverted L-shaped second elongated passage is parallel to the long extension on the right side of the U-shaped first elongated passage. The second compartment 23 includes a main central part that is partially divided from the second elongated passage by the second inner partition 28. The second elongated passage has a second end that communicates with the main central part.

[0275] Three expansion chambers 24a, 24b, 24c are formed in the main central part of the second compartment 23, and each of the expansion chambers 24a, 24b, 24c has a depth greater than the depth of other parts of the second compartment 23.

[0276] Two through-holes 29a, 29b (Figs. 2 and 3) pass through the main central part of the plastic rigid shell 20 and the second compartment 23. These two through-holes are surrounded and defined by respective additional partitions 30 connected to the first inner partition 27, and thus these additional partitions 30 also define the second compartment 23.

[0277] The first opening 29a and the second opening 29b are arranged between two of the three expansion chambers 24a, 24b, 24c. Among the three expansion chambers 24a, 24b, 24c, the first expansion chamber 24a is close to the bottom short side surface of the casing 19 and close to the short extension of the U-shaped first elongated passage. Among the three expansion chambers 24a, 24b, 24c, the second expansion chamber 24b is arranged between the first opening 29a and the second opening 29b. Among the three expansion chambers 24a, 24b, 24c, the third expansion chamber 24c is arranged above the second opening 29b.

[0278] The internal volume defined within the second compartment 23 is larger than the internal volume defined within the first compartment 22. For example, the internal volume of the second compartment 23 is about 55m 3 and the internal volume of the first compartment 22 is about 14m 3 is.

[0279] A hole 31 (Fig. 3) is formed in the front surface of the plastic rigid shell 20 arranged between the third expansion chamber 24c and the second inner partition 28. A rigid plastic frame 32 supporting the breathable membrane 33 is joined to the end of the hole 31 by welding or adhesion. The breathable membrane 33 may be PTFE (polytetrafluoroethylene).

[0280] When the assembly 3 is properly attached to the cycler 2, the upper part of the second compartment 23 provided with the breathable membrane 33 defines an air buffer capacity as described herein.

[0281] The plastic sheet 21 (Figure 4) is welded or bonded to the plastic rigid shell 20, and the plastic sheet 21 is joined to the outer bulkhead 26, the first inner bulkhead 27, the second inner bulkhead 28, and a further bulkhead 30 to seal the first compartment 22 and the second compartment 23.

[0282] The plastic rigid shell 20 includes a first pump port 34 with a hollow cylinder protruding from the right side of the casing 19 (Figures 3 and 8-11). The first pump port 34 is in liquid communication with the first compartment 22. The first pump port 34 opens into the first compartment at the end of the long extension on the right side of the U-shaped first elongated passage.

[0283] The plastic rigid shell 20 includes a second pump port 35 with a hollow cylinder protruding from the right side of the casing 19 (Figures 3 and 7-10). The second pump port 35 is in liquid communication with the second compartment 23. The second pump port 35 opens into the second compartment 23 at the first end of the second elongated passage.

[0284] The first pump port 34 and the second pump port 35 are close to each other but separated by the first inner partition wall 27. The hollow cylinders defining the first pump port 34 and the second pump port 35 spread out from each other away from the casing 19.

[0285] The plastic rigid shell 20 includes a drain port 36 with a hollow cylinder 37 that protrudes from the left side of the casing 19 (Figures 3 and 7-10).

[0286] The hollow cylinder 37 of the drain port 36 passes through the outer partition wall 26 so that the drain port 36 is in liquid communication with the first compartment 22.

[0287] The drain port 36 includes a short hollow barrel 38 connected to a hollow cylinder 37. The central axis of the hollow cylinder 37 is perpendicular to the main axis of the hollow barrel 38, and the cavity defined inside the hollow cylinder 37 and the hollow barrel 38 are in liquid communication with each other. The hollow barrel 38 protrudes from the bottom surface of the first compartment 22 and opens inside the first compartment 22 (FIGS. 6A and 6B).

[0288] When the plastic sheet 21 is not deformed as shown in FIG. 6A, the hollow barrel 38 is shorter than the adjacent outer partition wall 26 (shown in FIGS. 6A and 6B), shorter than the first inner partition wall 27, shorter than the second inner partition wall 28, and shorter than the further partition wall 30 so that the plastic sheet 21 is spaced apart from the end of the hollow barrel 38.

[0289] As described herein, the end of the hollow barrel 38 and a part of the plastic sheet 21 facing the end form the drain valve 39 of the drain port 36.

[0290] The plastic rigid shell 20 further includes a first dialysis port 40 and a second dialysis port 41. Each of these ports 40, 41 protrudes from the left side of the casing 19 (FIGS. 3 and 7 - 10) and has the same structure as the drain port 36 (hollow cylinder 37 and hollow barrel 38) detailed above.

[0291] The first dialysis port 40 and the second dialysis port 41 have respective receivable first dialysis valves 42 and second dialysis valves 43.

[0292] The plastic rigid shell 20 also protrudes from the left side of the casing 19 (FIGS. 3 and 7 - 10) and further includes a heater port 44 that is structurally similar to the drain port 36 (hollow cylinder 37 and hollow barrel 38) detailed above. The heater port 44 has a heater valve 45. The heater port 44 is arranged close to the upper left corner of the plastic rigid shell 20.

[0293] Unlike the drain port 36, the hollow barrel 38 of the heater port 44 is also in fluid communication with an opening 46 formed through the front surface of the casing 19, as well as the first dialysis port 40 and the second dialysis port 41 (Figure 7).

[0294] The plastic rigid shell 20 is located within the second compartment 23 and includes a further hollow barrel 47 adjacent to the hollow barrel 38 of the heater port 44. The first inner bulkhead 27 is located between the further hollow barrel 47 and the hollow barrel 38.

[0295] A further hollow barrel 47 is in liquid communication with a further opening 48 formed through the front of the casing 19 (Figure 7), and the opening 46 and the further opening 48 are connected by a bypass channel 49 defined by a cover 50 welded or bonded to the front of the plastic rigid shell 20. The bypass channel 49 is in liquid communication with the first compartment 22, the second compartment 23, and the heater line tube 63.

[0296] The end of the further hollow barrel 47 and a portion of the plastic sheet 21 facing that end form a bypass valve 51. The further hollow barrel 47 is part of a bypass port 52 in which the bypass valve 51 is provided.

[0297] The second inner bulkhead 28 separates the area of ​​the second compartment 23, which has a hole 31 and a permeable membrane 33, from the bypass valve 51 (Figures 3 and 8).

[0298] The plastic rigid shell 20 further includes a patient port 53. The patient port 53 protrudes from the left side of the casing 19 (Figures 3 and 7-10) and has the same structure as the drain port 36 (hollow cylinder 37 and hollow barrel 38) described in detail above.

[0299] The hollow cylinder 37 of the patient port 53 passes through the outer partition 26 and the first inner partition 27, thereby establishing fluid communication between the patient port 53 and the second compartment 23 (Figure 3). The patient port 53 has a patient valve 54.

[0300] All valves (drain valve 39, first dialysis valve 42, second dialysis valve 43, heater valve 45, bypass valve 51, patient valve 54) are structurally and functionally identical, and when the manifold assembly 3 is properly mounted to the cyclorama 2, they are each positioned in front of the respective occlusion element 7 of the cyclorama 2. Each occlusion element 7 of the cyclorama 2 is configured to open or close its respective valve. In other embodiments, although not shown in the accompanying figures, the occlusion elements 7 may be mounted on a cover 16, and the structure of the manifold assembly 3 is such that it cooperates with the occlusion elements 7 on the cover 16.

[0301] The hollow cylinders 37 of the heater port 44, first dialysis port 40, second dialysis port 41, drain port 36, and patient port 53 are parallel to each other. In the embodiment of the attached drawings, when the manifold assembly 3 is properly mounted on the cyclorama 2, the heater port 44 is above the first dialysis port 40, which is then above the second dialysis port 41, which is then above the drain port 36, which is then above the patient port 53.

[0302] The first compartment 22, which is shaped like a U-shaped, elongated passage, extends between the heater port 44 and the first end of the first pump port 34. The second elongated passage has a first end connected to the second pump port 35.

[0303] The manifold assembly 3 includes a yielding pump tube 55 having a first end 56 connected to a first pump port 34 and a first compartment, and a second end 57 connected to a second pump port 35 and a second compartment 23 (Figure 1). The yielding pump tube 55 extends outside the casing 19 and is formed as a loop or as an eyelet having an omega "Ω" shape so as to be partially arranged around the rotor 12 of the peristaltic pump 6 of the cyclorama 2.

[0304] The manifold assembly 3 further comprises a patient line tube 58 having a first end connected to a patient port 53 and a second end connectable to the patient's peritoneal cavity; a first dialysate line tube 59 having a first end connected to a first dialysis port 40 and a second end connected to a first supply bag 60; a second dialysate line tube 61 having a first end connected to a second dialysis port 41 and a second end connected to a second supply bag 62; a heater line tube 63 having a first end connected to a heater port 44 and a second end connected to a heater bag 64; and a drain fluid line tube 65 having a first end connected to a drain port 36 and a second end connected to a drain 66 (Figure 3).

[0305] The patient line tube 58 may extend to a patient line connector, which may be connected to a patient transfer set that leads to an indwelling catheter extending into the patient's peritoneal cavity, for example.

[0306] The first compartment 22, the yielding pump tube 55, and the second compartment 23 define fluid pathways extending between one of the first dialysate line tube 59, the second dialysate line tube 61, the heater line tube 63, the drain fluid line tube 65, and the patient line tube 58, allowing fluid to flow from one of the fluid line tubes to the patient line tube 58, or from the patient line tube 58 to one of the fluid line tubes, when the peristaltic pump 6 of the cyclorama 2 is activated.

[0307] The casing 19 of the manifold assembly 3 is attached to the front panel 13 of the cyclorama 2, the yielding pump tube 55 is coupled to the rotor 12, and the first dialysate line tube 59, the second dialysate line tube 61, the heater line tube 63, and the drain fluid line tube 65 are appropriately positioned and connected to the first supply bag 60, the second supply bag 62, the heater bag 64, and the drain 66, respectively. The patient line tube 58 is appropriately positioned and connected to patient P. The heater bag 64 is coupled to the heater of the cyclorama 2.

[0308] The shape of the casing 19, which has three protrusions 25a, 25b, and 25c and two through-holes 29a and 29b, facilitates the user to grasp the casing 19 and attach it to the cycra 2.

[0309] The user closes the lid 16 so that the first level sensor 8 and the second level sensor 9 are positioned in front of the outer flat surface of the casing 19. Figures 2 and 4 show the positions of the first level sensor 8 and the second level sensor 9 when the lid 16 is closed. In Figure 2, the positions of the first level sensor 8 and the second level sensor 9 are schematically shown through dashed circles.

[0310] The first level sensor 8 and the second level sensor 9 are arranged vertically. The first level sensor 8 is positioned between the third expansion chamber 24c and the second expansion chamber 24b. The second level sensor 9 is positioned between the second expansion chamber 24b and the first expansion chamber 24a.

[0311] When the lid 16 is closed, the coupling end 18 of the air conduit 17 is coupled to the rigid plastic frame 32 that supports the permeable membrane 33 (Figures 4 and 5) such that the coupling end 18 faces the permeable membrane 33. In this way, the pressure transducer 10 and air pump 11 of the Cycla 2 communicate with the permeable membrane 33 and the upper part of the second compartment 23, i.e., the air buffer capacity.

[0312] According to the method for controlling the peritoneal dialysis machine 1, the control unit 5 commands the actuators of the occlusion element 7 to open or close the drain valve 39, the first dialysis valve 42, the second dialysis valve 43, the heater valve 45, the bypass valve 51, and the patient valve 54, according to the steps to be performed.

[0313] When the valve 54 of the patient port 53 is open, the patient line tube 58 is in fluid communication with the second compartment 23, and when the valve 54 of the patient port 53 is closed, fluid communication between the patient line tube 58 and the second compartment 23 is prevented.

[0314] When the first dialysis valve 42 of the first dialysis port 40 is open, the first dialysis line tube 59 is in fluid communication with the first compartment 22, and when the first dialysis valve 42 of the first dialysis port 40 is closed, fluid communication between the first dialysis line tube 59 and the first compartment 22 is prevented.

[0315] When the second dialysis valve 43 of the second dialysis port 41 is open, the second dialysis line tube 61 is in fluid communication with the first compartment 22, and when the second dialysis valve 43 of the second dialysis port 41 is closed, fluid communication between the second dialysis line tube 61 and the first compartment 22 is prevented.

[0316] When the heater valve 45 of the heater port 44 is open, the heater line tube 63 is in liquid communication with the first compartment 22, and when the heater valve 45 of the heater port 44 is closed, liquid communication between the heater line tube 63 and the first compartment 22 is prevented.

[0317] When the drain valve 39 of the drain port 36 is open, the drain liquid line tube 65 is in liquid communication with the first compartment 22, and when the drain valve 39 of the drain port 36 is closed, liquid communication between the liquid drain line tube 65 and the first compartment 22 is prevented.

[0318] When the bypass valve 51 of the bypass port 52 is open, the heater line tube 63 is in liquid communication with the second compartment 23, and when the bypass valve 51 of the bypass port 52 is closed, liquid communication between the heater line tube 63 and the second compartment 23 is prevented.

[0319] As shown in Figures 6A, 6B, and 7, when the actuator holds the plunger 15 of the blocking element 7 in the retracted position in Figure 6A, the plastic sheet 21 separates from the end of the hollow barrel 38, and the liquid can flow between the hollow barrel 38 and the first compartment 22 (the valve opens).

[0320] When the actuator moves the plunger 15 of the blocking element 7 to the forward position shown in Figure 6B, and the plunger 15 is held in the forward position, the plunger 15 is partially housed within the hollow barrel 38.

[0321] The plunger 15 presses, deforms, and holds a portion of the plastic sheet 21 against the end of the hollow barrel 38. The hollow barrel 38 is a seat for the plunger 15 and for the portion of the plastic sheet 21 trapped between them. The flow of liquid between the hollow barrel 38 and the first compartment 22 is prevented (the valve closes). All valves operate in this manner.

[0322] Before treating the patient, manifold assembly 3 is prepared. Possible preparation sequences are shown in the following table (Table 1).

[0323] [Table 1]

[0324] Another preparation procedure may be carried out using a connecting pipe, as disclosed in Table 2 below.

[0325] [Table 2]

[0326] After preparation, treatment for the patient can be initiated.

[0327] According to one embodiment of a method for controlling a peritoneal dialysis machine 1 (Figures 8 and 12), the control unit 5 instructs the peritoneal dialysis machine 1 to transfer dialysate from the first supply bag 60 to the patient P.

[0328] The control unit 5 closes and keeps closed the heater valve 45, bypass valve 51, second dialysis valve 43, and drain valve 39, and opens and keeps open the first dialysis valve 42 and patient valve 54. The control unit 5 commands the motor to rotate the peristaltic pump 6 in the first rotational direction (counterclockwise in Figure 8) to send dialysate from the first compartment 22 to the second compartment 23.

[0329] An auxiliary inline heater (not shown) may be placed on the first dialysate line tube 59 to heat the dialysate as it flows through the dialysate line tube 59 toward the patient P.

[0330] According to another embodiment of the method for controlling the peritoneal dialysis machine 1 (Figures 9, 10, 11, 13, 14, 15), the control unit 5 instructs the peritoneal dialysis machine 1 to move the dialysate from the first supply bag 60 toward the heater bag 64. In this embodiment, an auxiliary inline heater is not used.

[0331] The control unit 5 closes the heater valve 45, the second dialysis valve 43, the drain valve 39, and the patient valve 54, and keeps them closed, while opening the bypass valve 51 and the first dialysis valve 42, and keeping them open. The control unit 5 commands the motor to rotate the peristaltic pump 6 in the first rotational direction (counterclockwise in Figure 9) so that dialysate is sent from the first compartment 22 to the second compartment 23, and then through the bypass channel 49 to the heater bag 64.

[0332] When the dialysate is heated in the heater bag 64 connected to the heater of the cyclo2, the control unit 5 instructs the peritoneal dialysis machine 1 to move the heated dialysate from the heater bag 64 toward the patient P.

[0333] The control unit 5 opens and keeps open the heater valve 45 and the patient valve 54, and closes and keeps closed the bypass valve 51, the first dialysis valve 42, the second dialysis valve 43, and the drain valve 39. The control unit 5 commands the motor to rotate the peristaltic pump 6 in the first rotational direction (counterclockwise in Figure 10) to send dialysate from the first compartment 22 to the second compartment 23.

[0334] At the end of the patient's treatment, the used dialysate is removed from patient P. The control unit 5 instructs the peritoneal dialysis machine 1 to move the used dialysate from patient P towards drain 66.

[0335] The control unit 5 opens and keeps open the drain valve 39 and the patient valve 54, and closes and keeps closed the heater valve 45, the bypass valve 51, the first dialysis valve 42, and the second dialysis valve 43. The control unit 5 commands the motor to rotate the peristaltic pump 6 in the second rotation direction (clockwise in Figure 11) to send dialysate from the second compartment 23 to the first compartment 22.

[0336] This treatment sequence is shown in the following table (Table 3).

[0337] [Table 3]

[0338] Embodiment 2

[0339] Figures 16 and 17 show another embodiment of the manifold assembly 3 of the peritoneal dialysis machine 1 (APD). The cyclorama 2 in this embodiment is not shown and may have the same structure / architecture as disclosed for the first embodiment.

[0340] Manifold assembly 3 (Figures 16 and 17), which organizes the tubing and performs many of the functions described herein, differs from manifold assembly 3 of Embodiment 1 in the following features.

[0341] As can be seen by comparing Figure 3 and Figure 16 (the same reference numerals are used for the same elements), the first dialysis port 40 and the second dialysis port 41 open inside the second compartment 23 instead of the first compartment 22. The first dialysis valve 42 and the second dialysis valve 43 are located within the second compartment 23 and are close to the second expansion chamber 24b.

[0342] The first dialysate line tube 59 has a first end connected to the first supply bag 60 and a second end connected to the second compartment 23. The second dialysate line tube 61 has a first end connected to the second supply bag 62 and a second end connected to the second compartment 23.

[0343] Furthermore, the drain port 36 and drain fluid line tube 65 are located close to the top of the casing 19 and, when the manifold assembly 3 is properly attached to the cyclorama 2, are positioned above the heater port 44 and heater line tube 63.

[0344] The second inner partition 28 is adjacent to the second pump port 35 and has a first end connected to the right long side of the plastic rigid shell 20. Unlike the embodiment in Figure 3, the area of ​​the second compartment 23 having the hole 31 and the permeable membrane 33 is not separated from the bypass valve 51 by the second inner partition 28.

[0345] Furthermore, the holes 31 and the breathable membrane 33 are located next to the upper short side of the plastic rigid shell 20.

[0346] Area 67 of the plastic sheet 21 is configured to connect to the displacement sensor 68 (shown schematically only) of the cyclorama 2 when the manifold assembly 3 is properly attached to the cyclorama 2.

[0347] Figure 16 shows that area 67 faces the zone of the first compartment 22, which is located at the elbow at the bottom right of the first elongated passage, which is essentially U-shaped. A displacement sensor 68 is mounted on the front panel 13 of the cyclorama 2.

[0348] The flow routes from the heater bag 64 to patient P, and from patient P to the drain, are the same as those disclosed in the preceding section, as shown in Figures 10 and 11.

[0349] Because the positions of the first dialysis valve 42 and the second dialysis valve 43 are different, the flow route from the first supply bag 60 to the heater bag 64 is different from that shown in Figure 9.

[0350] In fact, in this second embodiment (Figures 17 and 18), the control unit 5 closes and keeps the bypass valve 51, the second dialysis valve 43, the drain valve 39, and the patient valve 54 closed, and opens and keeps the heater valve 45 and the first dialysis valve 42 open. The control unit 5 commands the motor to rotate the peristaltic pump 6 in the second rotational direction (clockwise in Figure 9) to send dialysate from the second compartment 23 to the first compartment 22.

[0351] The treatment sequence for the manifold assembly 3 of the second embodiment is shown in the following table (Table 4).

[0352] [Table 4]

[0353] Before treating the patient, the manifold assembly 3 of the second embodiment is prepared. Possible preparation sequences are shown in the following table (Table 5).

[0354] [Table 5]

[0355] Embodiment 3

[0356] Figure 19 shows another embodiment of the manifold assembly 3 of the peritoneal dialysis machine 1 (APD). The cyclorama 2 in this embodiment differs from the first embodiment in that the valve is not part of the casing 7, and the occlusion element of the cyclorama 2 is a pinch valve.

[0357] In this third embodiment, as in the second embodiment, as can be seen by comparing Figures 3, 16, and 19 (the same reference numerals are used for the same elements), the first dialysis port 40 and the second dialysis port 41 open inside the second compartment 23 instead of the first compartment 22.

[0358] None of the ports are equipped with valves or valve parts. The drain port 36 and the drain fluid line tube 65 are located close to the top of the casing 19, similar to the second embodiment.

[0359] The second inner partition wall 28 separates the area of ​​the second compartment 23 having the hole 31 and a permeable membrane from the area of ​​the second compartment 23 having an auxiliary drain fluid port 69 connected to an auxiliary drain line tube 70.

[0360] The drain valve 39, first dialysis valve 42, second dialysis valve 43, heater valve 45, and patient valve 54 are clamp sections of the cyclorama 2 and operate on the tube sections of the drain fluid line tube 65, first dialysis fluid line tube 59, second dialysis fluid line tube 61, heater line tube 63, and patient line tube 58. The clamps and tube sections form a pinch valve with respect to each other.

[0361] In addition, an auxiliary drain valve 71 is activated on the auxiliary drain fluid line tube 70, and the drain fluid line tube 65 merges with the auxiliary drain fluid line tube 70 in the common drain line before reaching the drain 66 (Figure 19).

[0362] The flow routes from the heater bag 64 to patient P, and from patient P to the drain, are the same as those disclosed in the preceding section (first embodiment) as shown in Figures 10 and 11.

[0363] The flow route from the first supply bag 60 to the heater bag 64 is the same as in the second embodiment (see Table 3).

[0364] Possible preparation sequences are shown in the following table (Table 6).

[0365] [Table 6]

[0366] valve

[0367] In some embodiments, the valves are part of the casing and have the shape shown in Figures 20A, 20B, and 20C. For example, all the valves in Embodiment 2 of Figures 16 and 17 (drain valve 39, first dialysis valve 42, second dialysis valve 43, heater valve 45, bypass valve 51, patient valve 54) are of the type shown in Figure 20A.

[0368] This type of valve is configured to work with the blocking element 7 shown in Figures 21A, 21B, 21C, 21D, 22, and 23.

[0369] The occlusion element 7, as in one of Figures 6A, 6B, and 7, comprises a plunger 15 and further comprises a mechanical tension-applying plunger 76. Both the plunger 15 and the tension-applying plunger 76 are mechanically coupled to the actuator 73 shown in Figures 22 and 23.

[0370] In the embodiment shown in Figure 22, the actuator 73 is a linear actuator connected to a shaft 74. The distal end of the shaft 74 supports a plunger 15, and a damping and / or elastic element 75 (like a spring) is positioned between the distal end and the plunger 15. The plunger 15 has a cup-like shape that houses a spring.

[0371] The damping and / or elastic element 75 reduces the force acting on the membrane 21, thereby preventing damage to the membrane 21.

[0372] Similar to Figures 16 and 17, the actuator 73 is configured to move the plunger 15 along the axial direction between a retracted position in which the plunger 15 is separated from the soft membrane 21 and the port is open, and an advanced position in which the plunger 15 is at least partially housed in the seat and the soft membrane 21 is deformed and trapped between the plunger 15 and the seat in order to close the port.

[0373] The membrane tensioner 72 is configured to counteract the expected negative pressure, which tends to keep the valve closed by raising the soft membrane 21 away from its seat when the plunger 15 returns to its retracted position.

[0374] The membrane tensioner 72 also includes a tension-applying plunger 76 that is mechanically connected to the actuator 73. The tension-applying plunger 76 is substantially cylindrical in shape, coaxial with the plunger 15, and surrounds at least a portion of the plunger 15.

[0375] The tension-applying plunger 76 comprises two arched walls 76a coaxial with the central axis. The walls 76a are spaced apart from each other to define two windows 76b between them (Figures 24 and 25).

[0376] The tension-applying plunger 76 is fitted onto the shaft 74 and is axially movable along the shaft 74. The boundary of the arched wall 76a of the tension-applying plunger 76 faces the soft membrane 21, and the plunger 15 can protrude from the tension-applying plunger 76.

[0377] The actuator 73 is also configured to move the tension-applying plunger 76 between a retracted position in which the tension-applying plunger 76 is separated from the soft membrane 21 and an advanced position in which the tension-applying plunger 76 engages with the soft membrane 21 at a location other than the end of the seat, moving the soft membrane 21 away from the end of the seat and extending the soft membrane 21 above the seat.

[0378] In other embodiments not shown, the tension-applying plunger 76 may be moved by an auxiliary actuator not shown.

[0379] The actuator 73 is housed within the box 4 of the cyclorama 2, and the plunger 15, tension-applying plunger 76, and shaft 74 are guided through an opening formed within the box 4 of the cyclorama 2.

[0380] The tension-applying plunger 76 is in the retracted position when the plunger 15 is in the forward position (Figures 21A and 21B). In this configuration, the plunger 15 protrudes from the tension-applying plunger 76.

[0381] The tension-applying plunger 76 is in the forward position when the plunger 15 is in the retracted position (Figures 21C and 21D). In this configuration, the plunger 15 is completely housed within the tension-applying plunger 76 and does not protrude beyond the boundary of the tension-applying plunger 76.

[0382] The blocking element 7 includes a reverse mechanism that connects the tension-applying plunger 76 and the plunger 15. The reverse mechanism is configured to move the plunger 15 in the opposite direction to the direction of movement of the tension-applying plunger 76 when the plunger 15 is moved by the actuator 73.

[0383] In the embodiment shown in Figure 22, the tension-applying plunger 76 includes a projection 77 extending parallel to the shaft 74 and a rocker lever 78. The first end of the rocker lever 78 is hinged to the shaft 74 of the plunger 15, the second end of the rocker lever 78 is hinged to the projection 77 of the tension-applying plunger 76, and the central part of the rocker lever 78 is hinged to a stationary part of the cyclorama 2, for example, a part of the box 4.

[0384] When the linear actuator moves the plunger 15 toward the forward position, the rocker lever 78 tilts, moving the tension-applying plunger 76 toward the retracted position.

[0385] The modified embodiment shown in Figure 22A includes an additional damping and / or elastic element 75a (spring) coupled to the tension-applying plunger 76. In this embodiment, the cylinder defining the tension-applying plunger 76 is in two parts. The first part is firmly connected to the projection 77. The second part supports the boundary of the arched wall 76a of the tension-applying plunger 76 facing the membrane 21. The additional damping and / or elastic element 75a is interposed between the first and second parts.

[0386] The additional damping and / or elastic element 75a reduces the force applied to the membrane 21 by the tension-applying plunger 76, thereby preventing damage to the membrane 21. A further function of the additional damping and / or elastic element 75a is to compensate for any possible plastic deformation of the membrane 21, which may lose its elasticity and become plastically deformed over time. Even if the membrane 21 is plastically stretched, the additional damping and / or elastic element 75a can always push the boundary of the arched wall 76a of the tension-applying plunger 76 against the membrane 21 (advancing position), moving the soft membrane 21 away from the end and stretching the soft membrane 21 above the seat.

[0387] In the embodiment shown in Figure 23, the actuator 73 is a stepping motor comprising a rotatable shaft 79 connected to the shaft 74 of the plunger 15. The rotatable shaft 79 has external threads and is coupled to the internal threads of the shaft 74 via a left-hand threaded coupling 80.

[0388] The shaft 74 has external threads and is connected to the internal threads of the tension-applying plunger 76 via a right-hand threaded fitting 81.

[0389] The tension-applying plunger 76 and shaft 74 are axially guided by a fixing element 82, for example, to a part of the box 4.

[0390] The rotation of the rotatable shaft 79, caused by the stepping motor, moves the shaft 74 only axially in a first direction (the shaft 74 does not rotate), for example, toward the forward position of the plunger 15.

[0391] For the left-hand threaded joint 80, the axial movement of the shaft 74 drives the rotation of the tension-applying plunger 76, and due to the different pitches of the left-hand threaded joint 80 and the right-hand threaded joint 81, it also drives the axial movement of the tension-applying plunger 76 in a second direction opposite to a first direction toward the retracted position of the tension plunger 76.

[0392] As the stepping motor moves the plunger 15 toward the forward position, the left-hand threaded coupling 80 and the right-hand threaded coupling 81 operate to move the tension-applying plunger 76 toward the retracted position.

[0393] To properly operate the plunger 15 and the membrane tensioner 72, the valve has a circular end 83 that defines a seat, and an auxiliary end 84 that partially extends around the circular end 83 and is spaced apart from the end 83.

[0394] Instead of the hollow barrel 38 in Figures 6A, 6B and 7, the valve comprises a molded member 85 that protrudes from the bottom of compartments 22 and 23, respectively, and has an end 83 and an auxiliary end 84.

[0395] The molded member 85 is substantially cylindrical and defines a central cylindrical cavity 86. The end 83 defines the upper part of the cavity 86, and the auxiliary end 84 has two arch-shaped sections coaxial with the cavity and the end 83.

[0396] As shown in Figures 20A to 21D, when the manifold assembly 3 is properly mounted to site 14 of the cyclorama 2, the auxiliary end 84 is raised relative to the end 83 so that it is closer to the occluding element than the end 83.

[0397] Figures 21A to 21D show the operation steps of the assembly comprising the valve and the blocking element 7.

[0398] In Figure 21A, the valve is closed. The plunger 15 is in the forward position and partially housed in the seat, and the soft membrane 21 is trapped between the plunger 15 and the end 83.

[0399] In Figure 21B, the valve remains closed even when the plunger 15 is partially lifted due to the negative pressure that holds the soft membrane 21 against the end 83.

[0400] In Figure 21C, the tension-applying plunger 76, in its forward position, partially surrounds the molding member 85 and the auxiliary end 84, pulling the soft film 21 relative to the auxiliary end 84, causing the valve to open. In this way, the soft film 21 separates from the end 83.

[0401] In this position, the molding member 85 is positioned at least partially inside the tension-applying plunger 76. As shown in Figure 25, each arched wall 76a of the tension-applying plunger 76 is positioned close to one of the two arched portions of the auxiliary end 84 and radially outward from the arched portion of the auxiliary end 84.

[0402] Window 76b faces a radial opening defined between the arched walls 76a, allowing liquid communication between the cylindrical cavity 86 and either the first compartment 22 or the second compartment 23, and thus the valve is open (Figure 21D).

[0403] The valve and occlusion element 7 structures disclosed herein may also be part of other types of medical devices (e.g., dialysis machines for extracorporeal blood treatment) that are not necessarily peritoneal dialysis machines disclosed above.

[0404] The medical device may include a dialysis machine and a manifold assembly, the manifold assembly being attached to or attachable to the dialysis machine.

[0405] The manifold assembly comprises a casing having a rigid shell and at least one flexible membrane, the rigid shell and flexible membrane defining at least a first liquid passage. The rigid shell has at least one port that communicates with the first and second liquid passages. The at least one port has a seat and a flexible membrane facing the seat.

[0406] The dialysis machine comprises at least one occlusion element 7, which faces a seat between which a soft membrane 21 is placed when the manifold assembly is properly mounted to the dialysis machine. The seat is configured to at least partially accommodate each of the occlusion elements 7 of the dialysis machine.

[0407] A dialysis machine may be an apparatus for extracorporeal blood treatment, comprising: a blood treatment device; an extracorporeal blood circuit coupled to the blood treatment device; a blood pump, wherein the pump section of the extracorporeal blood circuit is configured to be coupled to the blood pump; and a therapeutic fluid circuit operably connected to the extracorporeal blood circuit and / or the blood treatment device. The therapeutic fluid circuit comprises a dialysis line connected to the liquid chamber of the treatment unit and a liquid discharge line connected to the liquid chamber. The therapeutic fluid circuit comprises an infusion circuit having one or more infusion lines for replacement fluid. A manifold assembly may be part of the extracorporeal blood circuit or the therapeutic fluid circuit.

[0408] calibration

[0409] The manifold assembly 3 described above may be used to estimate the stroke volume of the yielding pump tube 55 connected to the peristaltic pump 6 in order to calibrate the peristaltic pump 6, that is, to meet volumetric accuracy measurement requirements.

[0410] The following description refers to the manifold assembly 3 of the second embodiment shown in Figures 16 and 17. This embodiment is also shown in Figures 25 and 26. The upper part of the second compartment 23 and the air buffer capacity are in liquid communication with the auxiliary chamber 87 portion of the cyclorama 2 via a hole 31, a permeable membrane 33, and an air filter 88. A pressure transducer 10 is connected to the auxiliary chamber 87, and an air valve 89 allows the auxiliary chamber 87 to open or close communication with the outside air.

[0411] The peristaltic pump 6 is equipped with an encoder or coupled to an encoder not shown in the accompanying diagram. The encoder is operably connected to the control unit 5 and configured to detect the position and movement of the pressing roller 6a of the peristaltic pump 6.

[0412] The control unit 5 is operably connected to the motor of the peristaltic pump 6, the first level sensor 8, the second level sensor 9, the air valve 10, the actuator of the occlusion element 7, and the pressure transducer 10, and is configured and / or programmed to calibrate the peristaltic pump 6 in accordance with the method detailed herein.

[0413] As shown in Figure 26, the first level sensor 8 or high-level sensor and the second level sensor 9 or low-level sensor define high level "C" and low level "A" in the second compartment 23.

[0414] The first volume "V1" is defined below the low level "A" within the second compartment 23. The first volume "V1" is approximately 10 ml. The second volume "V2" is defined between the low level "A" and the high level "C" within the second compartment 23. The second volume "V2" is 2 to 4 times the nominal stroke fluid volume of the peristaltic pump 6. The nominal stroke fluid volume of the peristaltic pump 6 may be 7 ml, and the second volume "V2" is approximately 21 ml. The third volume "V3" is defined above the high level "C" within the second compartment 23. The third volume "V3" is approximately 15 ml. The auxiliary chamber 87 defines the interior of the fourth volume "V4" of approximately 26 ml. The sum of the second, third, and fourth volumes is approximately 62 ml.

[0415] The yielding pump tube 55, which is formed as a loop, comprises a curved section 55a and two straight sections 55b. The curved section 55a and the two straight sections 55b form a single tube. The straight sections 55b are connected to the first pump port 34 and the second pump port 35, respectively. The curved section 55a is configured to be pressed and deformed / compressed by the pressure roller 6a of the peristaltic pump 6.

[0416] As shown in Figure 25, when the peristaltic pump 6 rotates counterclockwise, each of the two pressing rollers 6a begins to press the curved section 55a at the bottom between the curved section 55a and the lower of the two straight sections 55b, and releases the curved section 55a at the top between the curved section 55a and the upper of the two straight sections 55b.

[0417] To calibrate the peristaltic pump 6, that is, to estimate the stroke fluid volume of the yielding pump tube 55, the following procedure is performed (see Figures 25-28).

[0418] The drain valve 39, the first dialysis valve 42, the second dialysis valve 43, the bypass valve 51, and the patient valve 54 are closed. The heater valve 45 is open, and the heater bag 64 is filled with water. The air valve 89 is open.

[0419] The control unit 5 controls the peristaltic pump 6 to start rotating counterclockwise, sending water from the heater bag 64 into the first compartment 22, and then into the second compartment 23. When the low-level sensor 9 detects water (Figure 27A) II ), the peristaltic pump 6 stops.

[0420] Subsequently, the peristaltic pump 6 is rotated clockwise to lower the water level until the low-level water level sensor 9 no longer detects water, and then it is stopped again (Figure 27A). I ).

[0421] The peristaltic pump 6 is rotated counterclockwise again. When the low-level sensor 9 detects water again (low liquid level A in Figures 26 and 27), the control unit 5 controls the peristaltic pump 6 to continue rotating counterclockwise and pump water into the second compartment 23. Meanwhile, the control unit 5 starts counting encoder pulses, which begin with the detection of water by the low-level sensor 9.

[0422] When a predetermined number of pulses "Delta_Encoder_Pulses" (e.g., 280 pulses) corresponding to a predetermined rotation angle "Delta" (e.g., 105°) of the peristaltic pump 6 are reached and the water level is at the first level B (Figures 26 and 27), the air valve 89 is closed and the peristaltic pump 6 continues to rotate counterclockwise, pumping more water into the second compartment 23 and compressing the air in the volume above the water level.

[0423] Of the two pressure rollers 6a, the position of one at the end of a predetermined rotation angle "Delta" is the predetermined position. Such a predetermined position may be the portion between the curved section 55a and one of the two straight sections 55b of the yielding pump tube 55. The water level when the pressure roller 6a is in the predetermined position is the first level B. An additional amount of water "Extra_Volume" is pumped up to raise the level from the low liquid level A to the first level B (Figures 26 and 27).

[0424] Starting from a predetermined position and first level B of the peristaltic pump 6, the control unit 5 rotates the peristaltic pump 6 by a predetermined counterclockwise rotation "Rotor_rev" defined by "n" half rotations of the peristaltic pump 6, where "n" is an integer (for example, n=7). The rotational speed of the peristaltic pump 6 may be 5 rpm.

[0425] In this way, at the end of the n half-rotations, the same pressure roller 6a is repositioned in place, and the water level is raised to the second level D.

[0426] Since the pressing roller 6a passes through a predetermined position several times during "n" half-rotations, when the pressing element 6a is in the predetermined position for the first time after sensing the high level C, the water level is sensed via the high level sensor 8, and the rotation of the peristaltic pump 6 is stopped (Figures 26 and 27).

[0427] The air pressure in the second compartment 23 is measured by the pressure transducer 10. Initial pressure P before air compression (first level B) Init and the final pressure P after air compression (Level 2 D) Final The following results are obtained. The initial pressure PInit is approximately 0 mmHg (difference pressure relative to atmospheric pressure), and the final pressure is approximately 400 mmHg.

[0428] After stopping the rotation of the peristaltic pump 6, the final pressure P Final Before obtaining the result, a waiting period for stabilization and continuous pressure measurement are provided to check for the possibility of leakage (Figure 27, D I ).

[0429] Subsequently, the change in liquid volume "Vol_Moved" in the second compartment 23, caused by the rotation of the peristaltic pump 6 at a predetermined rotation "Rotor_rev", is compared with the initial air volume "Compensated_Volume" above the first level B and the initial pressure P Init and final pressure P Final It is calculated accordingly.

[0430] The initial air volume "Compensated_Volume" is the difference between the air volume above the low liquid level "A" (i.e., V2 + V3 + V4) and the additional water volume "Extra_Volume", where the additional water volume "Extra_Volume" is the amount of water between the first level B and the low liquid level A, i.e., the amount of water transferred by the rotation "Delta" of the peristaltic pump 6.

[0431] The stroke fluid volume "stroke_Vol_Press" of the peristaltic pump 6 is calculated as the ratio between the change in fluid volume "Vol_Moved" and "n" half-rotations of the peristaltic pump 6. The calculation of the disclosed stroke fluid volume "Stroke_Vol_Press" may be performed 2 to 5 times consecutively to determine the average stroke fluid volume.

[0432] The calibration method may also be provided including a peristaltic pump and may be performed in other medical devices comprising a medical machine with a manifold assembly, for example, in a device for in vitro treatment of blood of the type disclosed above.

[0433] The procedure detailed above can be summarized by the following formula. a. Vol_Extra=2×(Delta_Encoder_Pulses / m)×Stroke_Vol_Press b. Compensated_Volume=((V2+V3+V4)-Vol_Extra) c. Vol_Moved=Compensated_Volume×((Pressure_Final-Pressure_Init) / Pressure_Final) d. Rotor_rev=(Zc-Yc) / m e. Stroke_Vol_Press=2×(Vol_Moved / Rotor_rev f. Stroke_Vol_Press=2×(m / (Zc-Yc))×((V2+V3+V4)-(Delta_Encoder_Pulses / 2m×Stroke_Vol_Press))×((Pressure_Final-Pressure_Init) / Pressure_Final)) Stroke_Vol_Press can also be calculated from equation f, where, [Table 7]

Claims

1. A manifold assembly for a peritoneal dialysis machine, A casing (19) that internally defines the first compartment (22) and the second compartment (23), A yielding pump tube (55) having a first end connected to the first compartment (22) and a second end connected to the second compartment (23), wherein the yielding pump tube (55) extends outside the casing (19) so as to be connected to the peristaltic pump (6) of the cycla (2) of the peritoneal dialysis machine (1), and the casing (19) comprises a first pump port (34) connected to the first end of the yielding pump tube (55) and a second pump port (35) connected to the second end of the yielding pump tube (55), A plurality of line tubes (58, 59, 61, 63, 65) each having a first end connected to the first compartment (22) or the second compartment (23) and a second end connectable to a fluid supply source (60, 62, 64), a drain (66), or a patient (P), wherein the casing (19) comprises a plurality of line tubes (58, 59, 61, 63, 65) each having a plurality of ports (53, 36, 40, 41, 44) connected to the first end of one of the line tubes (58, 59, 61, 63, 65), Equipped with, The casing (19) has a front, a back and several sides, and has a substantially flat shape, the back is configured to be coupled to the front panel (13) of the cyclorama (2), The first pump port (34) and the second pump port (35) are located on the first side of the casing (19), and the ports (53, 36, 40, 41, 44) are located on the second side of the casing (19) opposite to the first side. A manifold assembly comprising a casing (19) having at least one projection (25a, 25b, 25c) defining at least one expansion chamber (24a, 24b, 24c) in the second compartment (23), wherein the at least one expansion chamber (24a, 24b, 24c) has a depth greater than the depth of the rest of the second compartment (23), and the projection (25a, 25b, 25c) protrudes from the front surface of the casing (19).

2. The assembly according to claim 1, wherein each of the first pump port (34), the second pump port (35), and the plurality of ports (53, 36, 40, 41, 44) protrudes from each of the sides of the casing (19).

3. An assembly according to claim 1 or 2, wherein each of the first pump port (34), the second pump port (35), and the plurality of ports (53, 36, 40, 41, 44) is shaped like a hollow cylinder, and the hollow cylinders of the plurality of ports (53, 36, 40, 41, 44) are parallel to each other.

4. An assembly according to claim 3, wherein the hollow cylinder of the first pump port (34) and the hollow cylinder of the second pump port (35) spread out from each other away from the casing (19) so that the yielding pump tube (55) is formed as an omega-shaped loop.

5. An assembly according to any one of claims 1 to 4, wherein the casing (19) has a substantially rectangular shape having two long sides and two short sides, the first side and the second side being both long sides of the casing (19), and the casing (19) comprises a rigid shell (20) defining the front and the plurality of sides of the casing (19), and a soft membrane (21) defining the back of the casing (19).

6. An assembly according to any one of claims 1 to 5, wherein the casing (19) has through-holes (29a, 29b) penetrating the casing (19), and the through-holes (29a, 29b) are configured to engage with retaining elements of the cyclorama (2).

7. The assembly according to claim 6, wherein the casing (19) comprises a plurality of protrusions (25a, 25b, 25c), and the through-holes (29a, 29b) are located between two of the protrusions (25a, 25b, 25c).

8. A manifold assembly for a peritoneal dialysis machine, A casing (19) that internally defines the first compartment (22) and the second compartment (23), A yielding pump tube (55) having a first end connected to the first compartment (22) and a second end connected to the second compartment (23), wherein the yielding pump tube (55) extends outside the casing (19) so as to be connected to the peristaltic pump (6) of the cycla (2) of the peritoneal dialysis machine (1), and the casing (19) comprises a first pump port (34) connected to the first end of the yielding pump tube (55) and a second pump port (35) connected to the second end of the yielding pump tube (55), A plurality of line tubes (58, 59, 61, 63, 65) each having a first end connected to the first compartment (22) or the second compartment (23) and a second end connectable to a fluid supply source (60, 62, 64), a drain (66), or a patient (P), wherein the casing (19) comprises a plurality of line tubes (58, 59, 61, 63, 65) each having a plurality of ports (53, 36, 40, 41, 44) connected to the first end of one of the line tubes (58, 59, 61, 63, 65), Equipped with, The casing (19) has a front, a back and several sides, and has a substantially flat shape, the back is configured to be coupled to the front panel (13) of the cyclorama (2), The first pump port (34) and the second pump port (35) are located on the first side of the casing (19), and the ports (53, 36, 40, 41, 44) are located on the second side of the casing (19) opposite to the first side. The casing (19) comprises a permeable membrane (33) joined to the end of a hole (31) of the casing (19), the permeable membrane (33) configured to communicate the pressure transducer (10) and / or air pump (11) of the cyclorama (2) with the upper part of the second compartment (23) when the manifold assembly (3) is properly attached to the cyclorama (2).

9. The assembly according to claim 8, wherein the hole (31) of the casing (19) is formed on the front surface of the casing (19), and the rigid frame (32) supports the breathable membrane (33).

10. The assembly according to claim 8 or 9, wherein the first compartment (22) is a U-shaped elongated passage, and the second compartment (23) is partially enclosed by the U-shaped elongated passage.

11. The assembly according to any one of claims 8 to 10, wherein the plurality of line tubes (58, 59, 61, 63, 65) are A patient line tube (58) having a first end connected to the second compartment (23) and a second end connectable to the peritoneal cavity of a patient (P), wherein the patient port (53) among the plurality of ports (53, 36, 40, 41, 44) is connected to the first end of the patient line tube (58), At least one liquid line tube (59, 61, 63, 65) having a first end connected to the first compartment (22) and a second end connectable to a liquid supply source (60, 62, 64) or a drain (66), wherein at least one liquid line tube (59, 61) has a first end connected to or connectable to the second compartment (23) and a second end connectable to a liquid supply source (60, 62), and the liquid port (36, 40, 41, 44) among the plurality of ports (53, 36, 40, 41, 44) is connected to one of the first ends of the liquid line tube (59, 61, 63, 65), An assembly comprising:

12. An assembly according to any one of claims 8 to 11, wherein the casing (19) comprises a bypass channel (49) that is in liquid communication with the first compartment (22) and the second compartment (23) and the heater line tube (63), and the bypass channel (49) is at least partially defined by a cover (50) bonded to the outer surface of the casing (19).

13. A manifold assembly for a peritoneal dialysis machine, A casing (19) that internally defines the first compartment (22) and the second compartment (23), A yielding pump tube (55) having a first end (56) connected to the first compartment (22) and a second end (57) connected to the second compartment (23), wherein the yielding pump tube (55) extends outside the casing (19) so as to be connected to the peristaltic pump (6) of the cycla (2) of the peritoneal dialysis machine (1), A patient line tube (58) having a first end connected to the second compartment (23) and a second end connectable to the peritoneal cavity of the patient (P), At least one liquid line tube (59, 61, 63, 65) having a first end connected to the first compartment (22) and a second end connectable to a liquid supply source (60, 62, 64) or drain (66), At least one liquid line tube (59, 61) having a first end connected to or connectable to the second compartment (23) and a second end connectable to a liquid supply source (60, 62), Equipped with, The first compartment (22), the yielding pump tube (55), and the second compartment (23) together define a liquid path extending from the at least one liquid line tube (59, 61, 63, 65) having the first end connected to the first compartment (22), through the yielding pump tube, to the patient line tube (58), and when the peristaltic pump (6) of the cyclorama (2) is activated, at least the flow of liquid from the at least one liquid line tube (59, 61, 63, 65) having the first end connected to the first compartment (22), through the yielding pump tube, to the patient line tube (58), or from the patient line tube (58), through the yielding pump tube, to the at least one liquid line tube (59, 61, 63, 65) having the first end connected to the first compartment (22), The second compartment (23) defines a manifold assembly comprising at least one expansion chamber (24a, 24b, 24c) configured to attenuate pressure pulsations from the peristaltic pump (6).

14. The assembly according to claim 13, wherein the at least one expansion chamber (24a, 24b, 24c) is partially defined by a soft film, and the at least one soft film (21) is made of a plastic sheet.

15. The assembly according to claim 13 or 14, wherein the internal volume of the second compartment (23), which comprises at least one expansion chamber (24a, 24b, 24c), is greater than the internal volume of the first compartment (22).

16. An assembly according to any one of claims 13 to 15, wherein the casing (19) comprises a permeable membrane (33) configured to communicate the pressure transducer (10) and / or air pump (11) of the cyclorama (2) with the upper part of the second compartment (23).

17. An assembly according to any one of claims 13 to 16, wherein the at least one liquid line tube (59, 61, 63, 65) having a first end connected to the first compartment (22) comprises a heater line tube (63), a heater bag (64) connected to a second end of the heater line tube (63), and a drain liquid line tube (65) having a second end connectable to the drain (66), and the at least one liquid line tube (59, 61, 63, 65) having a first end connected to the first compartment (22) comprises a plurality of dialysate line tubes (59, 61) and supply bags (60, 62) connected to the second ends of the dialysate line tubes (59, 61).

18. An assembly according to any one of claims 13 to 16, wherein the at least one liquid line tube (59, 61) having a first end connected to the second compartment (23) comprises one or more dialysate line tubes (59, 61), and at least one supply bag (60, 62) is connected to the second end of the one or more dialysate line tubes (59, 61).

19. The assembly according to claim 13, wherein the casing (19) comprises a first pump port (34) connected to the first end (56) of the yielding pump tube (55) and in liquid communication with the first compartment (22), a second pump port (35) connected to the second end (57) of the yielding pump tube (55) and in liquid communication with the second compartment (23), and a patient port (53) connected to the first end of the patient line tube (58) and in liquid communication with the second compartment (23), An assembly comprising: at least one liquid port (44, 36) connected to the first end of the at least one liquid line tube (63, 65) having the first end connected to the first compartment (22), and communicating with the first compartment (22); and at least one liquid port (40, 41) connected to the first end of the at least one liquid line tube (59, 61) having the first end connected to the second compartment (23), and communicating with the second compartment (23).

20. The assembly according to claim 19, wherein the at least one liquid port (40, 41, 44, 36) comprises a valve (42, 43, 45, 39) or a portion of a valve, the at least one liquid port (40, 41, 44, 36) has a seat for at least partially accommodating each of the occlusion elements (7) of the cyclor (2), and the patient port (53) comprises a valve (54) or a portion of a valve, the at least one patient port (53) has a seat for at least partially accommodating each of the occlusion elements (7) of the cyclor (2).

21. The assembly according to claim 17, wherein the casing (19) comprises the first compartment (22), the second compartment (23), and a bypass channel (49) that communicates with a heater line tube (63) and liquid.

22. The assembly according to claim 21, wherein the first compartment (22) comprises a bypass port (52) which is in liquid communication with the bypass channel (49), the bypass port (52) comprises a valve (51) or a portion of a valve, and the bypass port (52) has a seat for accommodating at least a portion of the closure element (7) of the cyclor (2).

23. An assembly according to any one of claims 13 to 22, wherein the first compartment (22) is a first elongated passage extending between one of the at least one liquid line tubes (59, 61, 63, 65) and the first end (56) of the yielding pump tube (55), the first elongated passage being substantially U-shaped.

24. The assembly according to claim 23, wherein the first end of a heater line tube (63), the first end of a drain fluid line tube (65), and the first ends of a plurality of dialysate line tubes (59, 61) are sequentially arranged along the longest extension of the U-shaped elongated passage, and the first end (56) of the yielding pump tube (55) is connected to the end of the U-shaped elongated passage.

25. The assembly according to claim 23 or 24, wherein the second compartment (23) comprises a partition wall defining a second elongated passage that is in liquid communication with the at least one expansion chamber (24a, 24b, 24c), the second elongated passage having a first end connected to the second end (57) of the yielding pump tube (55) and a second end in communication with the at least one expansion chamber (24a, 24b, 24c).

26. An assembly according to any one of claims 13 to 25, wherein the casing (19) has a flat shape and comprises at least one projection (25a, 25b, 25c) defining the at least one expansion chamber (24a, 24b, 24c), the at least one expansion chamber (24a, 24b, 24c) having a depth greater than the depth of the rest of the second compartment (23).

27. An assembly according to any one of claims 13 to 26, wherein the casing (19) has an external flat surface for interface with at least one level sensor (8, 9) of the cyclorama (2) and openings (29a, 29b) through the external flat surface, a plurality of expansion chambers (24a, 24b, 24c) are defined in the second compartment (23), and the openings (29a, 29b) are positioned between two of the plurality of expansion chambers (24a, 24b, 24c).

28. An assembly according to any one of claims 13 to 27, wherein the casing (19) comprises a rigid shell (20) and at least one flexible membrane (21) made of a plastic sheet, the at least one flexible membrane (21) being welded or bonded to the rigid shell (20), the rigid shell (20) defining the front and side of the casing (19), the at least one flexible membrane (21) being the back of the casing (19), the at least one flexible membrane (21) facing a seat for at least partially accommodating each of the occlusion elements (7) of the cyclorama (2), and the flexible membrane (21) being configured to deform by the occlusion elements (7) when the occlusion elements (7) are accommodated in the seat, to close a patient port (53) or a fluid port (40, 41, 44, 36).

29. The assembly according to claim 28, wherein an area (67) of the at least one soft membrane (21) is configured to be coupled to a displacement sensor (68) of the cyclorama (2) when the assembly (3) is properly attached to the cyclorama (2), and the area (67) faces a zone of the first compartment (22).

Images