Manifold assembly for a peritoneal dialysis apparatus and peritoneal dialysis apparatus comprising the manifold assembly

Abstract

A manifold assembly for a peritoneal dialysis apparatus, comprising: a housing (19) internally delimiting a first compartment (22) and a second compartment (23); an outflow pump tube (55) having a first end (56) connected or connectable to the first compartment (22) and a second end (57) with the second compartment (23). The outflow pump tube (55) extends outside the housing (19) to be coupled with a peristaltic pump (6) of a cycler (2) of the peritoneal dialysis apparatus (1). A first pump port (34) and a second pump port (35) are placed on a first side of the housing (19), and ports (53, 36, 40, 41, 44) are placed on a second side of the housing (19) opposite the first side.

Description

Technical Field

[0001] This disclosure relates to a manifold assembly for a peritoneal dialysis device and a peritoneal dialysis device including said manifold assembly. This disclosure also relates to a method for controlling a peritoneal dialysis device.

[0002] The human kidney system can fail for a variety of reasons. Kidney failure can lead to a number of physiological disorders. The kidneys are no longer able to balance water and minerals or excrete the daily metabolic load. Toxic metabolic end products, such as urea, creatinine, and uric acid, may accumulate in the patient's blood and tissues.

[0003] Dialysis is used to treat declining kidney function (especially kidney failure). Dialysis removes waste products, toxins, and excess water from the body that can normally be removed by functioning kidneys. Dialysis is crucial for many people as it can save lives.

[0004] One type of treatment for kidney failure is peritoneal dialysis (“PD”), which involves injecting a dialysis solution (also called dialysis fluid) into the patient’s peritoneal cavity through a catheter. The dialysis fluid comes into contact with the peritoneum in the patient’s peritoneal cavity. Waste, toxins, and excess water enter the dialysis fluid from the patient’s bloodstream through the capillaries in the peritoneum due to diffusion and osmosis—that is, an osmotic gradient across the membrane. The osmotic agent in the PD dialysis fluid provides this osmotic gradient. Used or waste dialysis fluid is drained from the patient, removing waste, toxins, and excess water from the body. This cycle is repeated, for example, multiple times. Background Technology

[0005] There are several types of peritoneal dialysis therapy, including continuous ambulatory peritoneal dialysis (“CAPD”), automated peritoneal dialysis (“APD”), tidal flow dialysis, and continuous flow peritoneal dialysis (“CFPD”). CAPD is a manual dialysis therapy. Here, the patient manually connects an implanted catheter to the drain to allow used or waste dialysis fluid to drain from the peritoneal cavity. The patient then switches the fluid connection so that the catheter is connected to a bag of fresh dialysis fluid to infuse fresh dialysis fluid into the patient's body through the catheter. The patient disconnects the catheter from the bag of fresh dialysis fluid, allowing the dialysis fluid to remain in the peritoneal cavity, where waste, toxins, and excess water are transferred. After a period of time, the patient repeats the manual dialysis process, for example, four times a day. Manual peritoneal dialysis requires a significant investment of time and effort from the patient and still has considerable room for improvement.

[0006] Automated peritoneal dialysis (“APD”) is similar to CAPD in that dialysis treatment involves drainage, filling, and retention cycles. However, the APD machine performs the cycles automatically, typically while the patient is asleep. The APD machine frees patients from having to manually perform treatment cycles and transport supplies during the day. The APD machine is fluidly connected to an implanted catheter, a source or bag of fresh dialysis fluid, and a fluid drainage unit. The APD machine pumps fresh dialysis fluid from the source through the catheter and into the patient's peritoneal cavity. The APD machine also allows dialysis fluid to remain in the peritoneal cavity and allows waste, toxins, and excess water to be removed. This source can include multiple liters of dialysis fluid, comprising several solution bags.

[0007] The APD machine pumps used or waste dialysis fluid from the patient's peritoneal cavity to the drain via a catheter. Similar to the manual procedure, multiple cycles of draining, filling, and retention occur during dialysis. A "final fill" may occur at the end of an APD treatment. The final fill fluid can be retained in the patient's peritoneal cavity until the next treatment begins, or it can be manually emptied at some time of day.

[0008] Known APD systems include machines or circulators that receive and actuate disposable pumping devices or cartridges having rigid and flexible portions, the flexible portions being deformable to perform pumping and valve operation.

[0009] Most circulating pumps on the market rely on the compression / expansion of fluid volume within an expansion chamber, which is part of a disposable unit, to achieve a pumping system (alternating pumping system). Compression / expansion is performed through the action of a flexible diaphragm within the chamber of the disposable unit, resulting in a continuous flow of fluid masses whose volume is correlated with the volume of the expansion chamber itself. Using this design, the flow rate is controlled by leveraging the "ideal gas law" and incorporating knowledge of chamber volume and pressure monitoring, thereby controlling fluid volume exchange.

[0010] For example, such systems for performing peritoneal dialysis are disclosed in US2011 / 0092893 and US2020 / 0230310.

[0011] The main drawback of this method involves the management and regulation of low fluid flow rates (i.e., flow rates on the order of magnitude smaller than the volume of the device's expansion chamber (typically >15 ml)). Within such ranges, alternating pumping systems result in flow rate discretization and reduced accuracy. The ability to carefully control low flow rates is particularly important during the drainage phase from the patient, which is often reported as a painful part of the treatment.

[0012] Furthermore, compared to smooth and laminar flow conditions, the alternating pumping method results in slight pulsating flow, which does not represent the optimal conditions for the aforementioned stages of fluid drainage from the patient and for the administration phase.

[0013] Furthermore, sealing disposable fluid devices with pneumatic pathways via gaskets to provide actuation has proven to be a potential field problem, delaying treatment start time and impacting user experience.

[0014] Pneumatic cassette systems can also generate noise, which may be one reason for customer dissatisfaction.

[0015] Some types of circulators utilize scales to control the volume of exchanged fluid. The disadvantages of this method include the need for precise and frequent calibration of the scales on the circulator machine, an error-prone process that complicates the management of circulator maintenance.

[0016] Another common drawback of existing solutions is the lack of a method to manage and eliminate air bubbles that may be present in the “PD” solution to be administered to patients.

[0017] Systems for peritoneal dialysis using peristaltic pumps are also known. For example, such systems are disclosed in documents WO 2012129501A2, WO2019169081, US2005 / 0209563, and WO 2018237375.

[0018] These systems also have drawbacks related to requirements such as calibration, pulsating flow, and bubble removal.

[0019] Therefore, the object of the present invention is to provide a manifold assembly for a peritoneal dialysis device and a peritoneal dialysis device that allows for more precise and simple control of fluid flow and enhances the monitoring of the therapeutic effect of peritoneal dialysis.

[0020] The purpose of this invention is to provide a manifold assembly for a peritoneal dialysis device and a peritoneal dialysis device that can ensure continuous flow and can be adjusted and maintain high precision even at low flow rates (e.g., 5 ml / min-10 ml / min).

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

[0022] Another object of the present invention is to provide a manifold assembly and device that reduces the peristaltic effect of a pump, providing a flow that does not exhibit the typical pulsating flow of alternating pumping systems or prior art systems employing peristaltic pumps.

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

[0024] Another object of the present invention is to provide a manifold assembly and a device that allows detection of the potential occurrence of extreme negative pressure values ​​in a compartment connected to the drain and bag piping.

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

[0026] Another object of the present invention is to provide a manifold assembly and a device capable of monitoring the pressure value within the compartment of the manifold assembly connected to a patient line and regulating the fluid level within the compartment.

[0027] Another object of the present invention is to provide a manifold assembly that is reliable and can be easily interfaced / connected to the hardware components of the circulator of the device.

[0028] Another object of the present invention is to provide a manifold assembly that can be easily operated by the user and easily installed on / removed from the circulator of the device. Summary of the Invention

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

[0030] The following discloses a manifold assembly for a peritoneal dialysis device, a peritoneal dialysis device, and a method for controlling a peritoneal dialysis device, which are based on various aspects of the present invention and are capable of achieving one or more of the above-described objectives.

[0031] The first aspect relates to a manifold assembly for a peritoneal dialysis device, comprising: a housing that internally defines a first compartment and a second compartment; a production pump tube having a first end connected to or capable of being connected to the first compartment and a second end connected to or capable of being connected to the second compartment, wherein the production pump tube extends outside the housing to be coupled to a peristaltic pump of a circulator of the peritoneal dialysis device; and a plurality of tubing, each tubing having a first end connected to or capable of being connected to the first compartment or the second compartment and a second end connected to or capable of being connected to a fluid source or discharge section or a patient.

[0032] Optionally, the plurality of catheters include: a patient catheter having a first end connected to or capable of being connected to a second compartment and a second end capable of being connected to a patient's peritoneal cavity; at least one fluid catheter having a first end connected to or capable of being connected to a first compartment and a second end connected to or capable of being connected to a fluid source and / or discharge section; optionally, at least one fluid catheter having a first end connected to or capable of being connected to a second compartment and a second end connected to or capable of being connected to a fluid source.

[0033] The first compartment, the output pump tube, and the second compartment together define a fluid path extending between the at least one fluid line and the patient line, the first end of the fluid line being connected to the first compartment, thereby allowing fluid to flow at least from the at least one fluid line to the patient line, or from the patient line to the at least one fluid line, when the peristaltic pump of the circulator is actuated, the first end of the at least one fluid line being connected to the first compartment.

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

[0035] The third aspect relates to a method for controlling a peritoneal dialysis device as described above.

[0036] In the fourth aspect of the first aspect, the manifold assembly includes a hook element configured to removably hook the disposable assembly to the circulator, optionally to the front panel of the circulator; and / or a housing shaped to removably hook to the circulator, optionally to the front panel of the circulator; optionally, the manifold assembly is at least partially disposable or reusable.

[0037] In aspect 5 (which may be used in conjunction with any other aspect described herein), the second compartment defines at least one expansion chamber configured to reduce pressure pulsations from the peristaltic pump; optionally, the at least one expansion chamber is defined at least partially by a diaphragm; optionally, said at least one diaphragm is made of a plastic sheet, optionally made of polyvinyl chloride sheet.

[0038] In aspect 6 (which may be used in conjunction with any other aspect described herein), the housing has a generally flat shape.

[0039] In aspect 6, second (which may be used in conjunction with any other aspect described herein), the housing is provided with a front, a back, and multiple sides; optionally, the back is configured to be coupled to the front panel of the circulator.

[0040] In the third of the sixth aspect of the foregoing, the first pump port and the second pump port are located on the first side of the housing, while the port is located on the second side of the housing opposite to the first side.

[0041] In the fourth of the sixth aspect of the foregoing, the housing has a generally rectangular profile having two long sides and two short sides; optionally, the first side and the second side are both long sides of the housing.

[0042] In aspect 7 (which may be used in conjunction with any other aspect described herein), the first compartment and / or the second compartment are at least partially flat in shape.

[0043] In aspect 8 (which may be used in conjunction with any other aspect described herein), the at least one fluid line comprises: at least one dialysis fluid line; optionally, the at least one dialysis fluid line has a first end connected to a first compartment, or at least one dialysis fluid line has a first end connected to a second compartment.

[0044] In the ninth aspect of aspect 8, the fluid source connected to the second end of the at least one dialysis fluid line is a supply bag.

[0045] In a 10th aspect according to aspect 8 or 9, the at least one fluid line comprises: a plurality of dialysis fluid lines, optionally a first dialysis fluid line and a second dialysis fluid line.

[0046] In aspect 11 of aspect 10, each dialysis fluid line is connected to a corresponding supply bag.

[0047] In aspect 12 (which may be used in conjunction with any other aspect described herein), the at least one fluid conduit comprises: a heater conduit; optionally, the heater conduit has a first end connected to the first compartment.

[0048] In aspect 12, the fluid source connected to the second end of the heater conduit is a heating bag.

[0049] In aspect 14 of aspect 13, the heating bag is configured to be connected to the heater of the circulator.

[0050] In a second aspect of the 14th aspect of 11, an auxiliary in-line heater is placed on the at least one fluid line to heat the dialysis fluid as it flows through the dialysis fluid line.

[0051] In aspect 15 (which may be used in conjunction with any other aspect described herein), the at least one fluid line includes: a discharge fluid line; optionally, the discharge fluid line has a first end connected to a first compartment; optionally, the at least one fluid line further includes an auxiliary discharge fluid line having a first end connected to a second compartment.

[0052] In the 16th aspect according to aspect 15, the discharge fluid line and the optional auxiliary discharge fluid line have a second end that is connected to or can be connected to the discharge section: optionally, the discharge fluid line merges with the auxiliary discharge fluid line in a common discharge line before reaching the discharge section.

[0053] In aspect 17 (which may be used in conjunction with any other aspect described herein), the output pump tube has a curved shape.

[0054] In aspect 18 (which may be used in conjunction with any other aspect described herein), the output pump tube is shaped as a ring or eyelet, optionally having an "Ω" shape.

[0055] In aspect 19 (which may be used with any other aspect described herein), the housing includes a first pump port that is connected to or can be connected to a first end of a production pump tube and is in fluid communication with a first compartment.

[0056] In the 20th aspect according to aspect 19, the housing includes a second pump port that is connected to or can be connected to a second end of a production pump tube and is in fluid communication with a second compartment.

[0057] In aspect 21 according to aspects 19 and 20, the first pump port and the second pump port are separated from each other away from the housing.

[0058] In aspect 22 (which may be used in conjunction with any other aspect described herein), the housing includes a plurality of ports, each of which is connected to or is capable of being connected to a first end of a conduit.

[0059] In aspect 22 of the aforementioned aspect 22 and aspect 6 of the third, the first pump port, the second pump port, and the plurality of ports protrude from the respective sides of the housing; optionally, each of the first pump port, the second pump port, and the plurality of ports is shaped like a hollow cylinder; optionally, the hollow cylinders of the plurality of ports are parallel to each other.

[0060] In aspect 22, third (which may be used in conjunction with any other aspect described herein), the housing includes a patient port that is connected to or capable of being connected to a first end of a patient conduit and is in fluid communication with a second compartment.

[0061] In aspect 23 of aspect 22 of 3, the patient port includes a corresponding valve or part of a valve, i.e., a patient valve; or, the clamp of the circulator may be connected to the patient tubing to clamp the tubing.

[0062] In the 24th aspect according to aspect 22 or 23, the at least one patient port has a seat for at least partially accommodating a corresponding occlusion element of the circulator.

[0063] In aspect 25 according to aspect 24 (when used in conjunction with aspect 23), the occlusion element of the circulator is part of the patient valve.

[0064] In aspect 26, which is in accordance with aspect 23 or aspect 24 or 25 (when used with aspect 23), when the valve at the patient port is open, the patient line is in fluid communication with the second compartment; when the valve at the patient port is closed, the fluid communication between the patient line and the second compartment is prevented.

[0065] In aspect 27 (which may be used with any other aspect described herein), the housing includes at least one fluid port that is connected to or capable of being connected to a first end of the at least one fluid conduit and is in fluid communication with a first compartment or a second compartment.

[0066] In aspect 28 of aspect 27, the at least one fluid port includes a corresponding valve or part of a valve, i.e., a fluid valve; or alternatively, the clamp of the circulator may be coupled to a fluid line to clamp the line.

[0067] In aspect 29 according to aspect 27 or 28, the at least one fluid port has a seat for at least partially accommodating a corresponding closure element of the circulator.

[0068] In aspect 30 according to aspect 29 (when used in conjunction with aspect 28), the shut-off element of the circulator is part of the fluid valve.

[0069] In aspect 31, according to aspect 28 or aspect 29 or 30 (when used with aspect 28), when the valve of the at least one fluid port is open, the at least one fluid line is in fluid communication with the first compartment or the second compartment; when the valve of the at least one fluid port is closed, the fluid communication between the at least one fluid line and the first compartment or the second compartment is blocked.

[0070] In aspect 32 of any of aspects 27 to 31 (when used in conjunction with any of aspects 8 to 11), the at least one fluid port includes at least one dialysis fluid port connected to a first end of the at least one dialysis fluid line; alternatively, the at least one fluid port includes a first dialysis fluid port connected to a first end of a first dialysis fluid line and a second dialysis fluid port connected to a first end of a second dialysis fluid line.

[0071] In aspect 33 of aspect 32, the second end of the first dialysis fluid line is connected to the first supply bag, and the second end of the second dialysis fluid line is connected to the second supply bag.

[0072] In aspect 34 according to aspect 32 or 33, the at least one dialysis fluid port includes a corresponding valve or part of a valve, i.e., a dialysis valve, optionally a first dialysis valve and a second dialysis valve.

[0073] In aspect 35 according to any one of aspects 32 to 34, the at least one dialysis fluid port has a seat for at least partially accommodating a corresponding occlusion element of the circulator.

[0074] In aspect 36 according to aspect 35 (when used in conjunction with aspect 34), the closure element of the circulator is part of the dialysis valve.

[0075] In aspect 37, according to aspect 34 or aspect 35 or 36 (when used with aspect 34), when the valve of the at least one dialysis fluid port is open, the at least one dialysis fluid line is in fluid communication with the first compartment or the second compartment; when the valve of the at least one dialysis fluid port is closed, the fluid communication between the at least one dialysis fluid line and the first compartment or the second compartment is blocked.

[0076] In aspect 38, according to any one of aspects 27 to 31 (when used in conjunction with any one of aspects 12 to 14), the at least one fluid port includes a heater port connected to a first end of a heater conduit.

[0077] In aspect 39 of aspect 38, the heater port includes a corresponding valve or part of a valve, namely a heater valve.

[0078] In aspect 40 according to aspect 38 or 39, the heater port has a seat for at least partially accommodating a corresponding blocking element of the circulator.

[0079] In aspect 41 according to aspect 40 (when used in conjunction with aspect 39), the shut-off element of the circulator is part of the heater valve.

[0080] In aspect 42, which is in accordance with aspect 39 or aspect 40 or 41 (when used with aspect 39), when the valve at the heater port is open, the heater line is in fluid communication with the first compartment; when the valve at the heater port is closed, the fluid communication between the heater line and the first compartment is blocked.

[0081] In aspect 43 according to any one of aspects 27 to 31 (when used with aspect 15 or 16), the at least one fluid port includes a discharge port connected to a first end of a discharge fluid line; alternatively, the at least one fluid port includes an auxiliary discharge port connected to a first end of an auxiliary discharge fluid line.

[0082] In aspect 44 of aspect 43, the discharge port includes a corresponding valve or part of a valve, namely a discharge valve.

[0083] In aspect 45 according to aspect 43 or 44, the discharge port has a seat for at least partially accommodating a corresponding blocking element of the circulator.

[0084] In aspect 46 according to aspect 45 (when used in conjunction with aspect 44), the shut-off element of the circulator is part of the discharge valve.

[0085] In aspect 47, which is in accordance with aspect 44 or aspect 45 or 46 (when used with aspect 44), when the valve at the discharge port is open, the discharge line is in fluid communication with the first compartment; when the valve at the discharge port is closed, the fluid communication between the discharge line and the first compartment is blocked.

[0086] In aspect 48 of aspect 12, the housing includes a bypass passage in fluid communication with the first compartment, the second compartment and the heater line.

[0087] In aspect 48, second aspect 48, the bypass passage is defined at least partially by a cover that is connected to the outer surface of the housing, and optionally, to the front of the housing.

[0088] In aspect 49 of aspect 48, the second compartment includes a bypass port in fluid communication with a bypass passage.

[0089] In aspect 50 of aspect 49, the bypass port includes a corresponding valve or part of a valve, namely a bypass valve.

[0090] In aspect 51 according to aspect 49 or 50, the bypass port has a seat for at least partially accommodating a corresponding blocking element of the circulator.

[0091] In aspect 52 of aspect 51, the shut-off element of the circulator is part of the bypass valve.

[0092] In aspect 53, according to aspect 50 or aspect 51 or 52 (when used with aspect 50), when the valve of the bypass port is open, the heater line is in fluid communication with the second compartment; when the valve of the bypass port is closed, the fluid communication between the heater line and the second compartment is blocked.

[0093] In aspect 54 (which may be used in conjunction with any other aspect described herein), the first compartment is the first elongated passageway.

[0094] In aspect 55 of aspect 54, the first compartment extends between one of the fluid lines in at least one fluid line and the first end of the output pump line.

[0095] In aspect 56 according to aspect 54 or 55, the first elongated channel is generally U-shaped.

[0096] In aspect 57 according to any of aspects 54 to 56, the first end of the at least one fluid line and the first end of the discharge fluid line are arranged along a first elongated channel, one following the other.

[0097] In aspect 58 (which may be used in conjunction with any other aspect described herein), when the components are properly mounted on the circulator, the first end of the at least one fluid line and the first end of the discharge fluid line are arranged one on top of the other.

[0098] In aspect 59, according to any of aspects 54 to 56 (when used in conjunction with aspects 10 to 16), the first end of the heater line and the first end of the discharge fluid line, and optionally the first ends of a plurality of dialysis fluid lines, are arranged along a first elongated channel, one after the other; optionally along the longest portion of the U-shaped first elongated channel.

[0099] In aspect 60 according to aspects 10 to 16, when the assembly is suitably mounted on the circulator, the drain line is arranged above the patient line and optionally below the heating bag line and the plurality of dialysis fluid lines; or, optionally, when the assembly is suitably mounted on the circulator, the drain line is arranged above the patient line, the heating bag line and the plurality of dialysis fluid lines; optionally, when the manifold assembly is suitably mounted on the circulator, the drain line is arranged near the top of the housing; optionally, when the manifold assembly is suitably mounted on the circulator, the patient line is arranged near the bottom of the housing.

[0100] In aspect 61, according to aspect 56 or aspect 57 (when used with aspect 56), the first end of the output pump tube is connected to the end of the U-shaped elongated channel.

[0101] In aspect 62, which is based on aspect 56 or aspect 57 (when used with aspect 56), the second compartment is surrounded by a U-shaped elongated channel section.

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

[0103] In aspect 64 of aspect 63, at least two expansion chambers, optionally three expansion chambers, are defined in the second compartment.

[0104] In aspect 65 (which may be used in conjunction with any other aspect described herein), the internal volume of the second compartment, which includes at least one expansion chamber, is greater than the internal volume of the first compartment.

[0105] In aspect 66 (which may be used in conjunction with any other aspect described herein), the internal volume of the second compartment is 50 cm². 3 With 60cm 3 Between, optionally within 54cm 3 With 57cm 3 between.

[0106] In aspect 67 (which may be used in conjunction with any other aspect described herein), the internal volume of the first compartment is 8 cm. 3 With 20cm 3 Between, optionally within 14cm 3 With 18cm 3 between.

[0107] In aspect 68, according to aspect 63 or 64 (when used in conjunction with any of aspects 54 to 57), the second compartment includes a diaphragm that defines a second elongated channel in fluid communication with the at least one expansion chamber.

[0108] In aspect 69 of aspect 68, the second elongated channel has a first end connected to a second end of a production pump tube and a second end communicating with the at least one expansion chamber.

[0109] In the 70th aspect according to aspect 68 or 69, the second compartment includes a main central portion separated from a second elongated channel by a diaphragm.

[0110] In aspect 71 of aspect 70, at least one expansion chamber is defined in the main central portion.

[0111] In aspect 72 of aspect 5, the housing includes at least one recess / protrusion defining the at least one expansion chamber such that the depth of the at least one expansion chamber is greater than the depth of the remaining portion of the second compartment; optionally, the recess / protrusion protrudes from the front of the housing.

[0112] In aspect 73 of aspect 72, the external shape of the recess / protrusion is configured to be gripped by one of the user's hands.

[0113] In aspect 74 (which may be used in conjunction with any other aspect described herein), the housing has an external flat surface for docking with at least one level sensor of the circulator, and optionally with two level sensors of the circulator.

[0114] In aspect 75 of aspect 74, the at least one liquid level sensor is a capacitive sensor.

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

[0116] In aspect 77, according to any of aspects 74 to 76, when the components are properly mounted on the circulator, the two level sensors are positioned one on top of the other.

[0117] In aspect 78 (which may be used with any other aspect described herein), the housing has a through-hole passing through it; optionally, the through-hole is configured to engage with a retaining element of the circulator, optionally located on the front panel of the circulator.

[0118] In aspect 79 of aspect 78, a plurality of expansion chambers and / or recesses / protrusions are defined in a second compartment, and an aperture is located between two of the plurality of expansion chambers and / or recesses / protrusions.

[0119] In aspect 80 (which may be used in conjunction with any other aspect described herein), when the components are properly mounted on the circulator, the upper portion of the second compartment defines an air buffer volume; optionally, the air buffer volume is in communication with the pressure transducer and / or the air pump of the circulator.

[0120] In aspect 81 of aspect 80, the housing includes a breathable membrane configured to cause the pressure transducer and / or air pump of the circulator to communicate with the upper part and / or air buffer volume of the second compartment when the manifold assembly is properly mounted on the circulator.

[0121] In aspect 82 of aspect 81, the breathable membrane is welded or bonded to the rigid outer shell of the housing.

[0122] In aspect 83 of aspect 82, the breathable membrane is connected to the edge of the hole in the rigid housing.

[0123] In aspect 84 of aspect 82, a rigid frame supports a breathable membrane; optionally, the breathable membrane is connected to the rigid frame, and the rigid frame is connected to the edge of a hole in a rigid housing; optionally, the hole in the housing is formed on the front side of the housing.

[0124] In aspect 85, which is based on any of aspects 81 to 84, the breathable membrane is hydrophobic.

[0125] In aspect 86 (which may be used in conjunction with any other aspect described herein), the housing comprises a rigid outer shell and at least one soft membrane.

[0126] In aspect 87 of aspect 86, the rigid housing is made of rigid plastic, optionally molded.

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

[0128] In aspect 89 according to any one of aspects 86 to 88, the at least one PVC membrane is welded or bonded to a rigid housing.

[0129] In aspect 90 according to any of aspects 86 to 89, the rigid housing defines the front and sides of the housing, and the at least one flexible membrane is the back of the housing; optionally, a region of the at least one flexible membrane is configured to be coupled to a displacement sensor of the circulator when the component is properly mounted on the circulator; optionally, the region faces the region of the first compartment; optionally, the region is at the bend of the generally U-shaped first elongated channel.

[0130] In aspect 91, according to any one of aspects 86 to 89 (when used in conjunction with aspects 24 and 29), the at least one diaphragm faces the seat of the at least one fluid port and the patient port; wherein the diaphragm is configured to deform by the occlusion element of the circulator to close the patient port and / or the fluid port when the occlusion element is at least partially accommodated in the seat.

[0131] In aspect 92, according to any one of aspects 86 to 89 (when used with aspect 51), the at least one diaphragm faces the seat of the bypass port; wherein the diaphragm is configured to close the bypass port by deforming the blocking element when the blocking element is at least partially received in the seat.

[0132] In aspect 93 (which may be used in conjunction with any other aspect described herein), peritoneal dialysis equipment includes a circulator.

[0133] In aspect 94 of aspect 93, the circulator includes a peristaltic pump, optionally including a roller peristaltic pump; optionally, the peristaltic pump includes one or more clamping elements, optionally one or more pressure rollers; optionally, the peristaltic pump includes two clamping elements spaced 180° apart.

[0134] In the 95th aspect according to aspect 94, the output pump pipe is partially placed or configured to be partially placed around the rotor of the peristaltic pump.

[0135] In aspect 96 according to any one of aspects 93 to 95, the circulator includes at least one level sensor, optionally two level sensors; optionally, the circulator includes at least one displacement sensor.

[0136] In aspect 97, according to any one of aspects 93 to 96 (when used with aspect 13 or 14), the circulator includes a heater, wherein the heating bag is configured to be coupled to the heater.

[0137] In aspect 98, according to any one of aspects 93 to 97 (when used in conjunction with aspects 22 and 27), the circulator includes a plurality of occlusion elements; wherein each occlusion element is configured to be at least partially received in a corresponding seat of the fluid port and the patient port; or, alternatively, wherein the fluid port and the patient port have no seats, and each occlusion element is a clamp configured to clamp one of the fluid line tubes or the patient tube.

[0138] In aspect 99 according to aspect 98 (when used in conjunction with any of aspects 86 to 92), each occlusion element, together with a portion of the diaphragm and a corresponding seat, defines a valve, or each clamp, together with a portion of the fluid line, defines a clamp valve; optionally, a heater valve at the heater port, a bypass valve at the bypass port, a first dialysis valve at the first dialysis port, a second dialysis valve at the second dialysis port, a discharge valve at the discharge port, and a patient valve at the patient port; optionally, an auxiliary discharge valve at the auxiliary discharge port.

[0139] In aspect 100, according to any one of aspects 93 to 97 (when used in conjunction with any one of aspects 81 to 85), the circulator includes a pressure transducer and / or an air pump configured to communicate with a permeable membrane and / or an air buffer volume of the housing.

[0140] In aspect 101 of 100, the circulator includes an air duct in communication with a pressure transducer and / or an air pump, wherein the air duct has a connecting end configured to connect with a breathable membrane of the housing.

[0141] In aspect 102, which is based on aspect 94 or 95 or any of aspects 96 to 101 (when used with aspect 94 or 95), the circulator includes a housing with a front panel in which the rotor of the peristaltic pump is located.

[0142] In the 103rd aspect of aspect 102, the circulator includes a cover movable between a closed position and an open position, wherein in the closed position the cover covers the front panel, and in the open position the cover is spaced apart from the front panel to allow access to the front panel.

[0143] In aspect 104 of aspect 103, the front panel and / or cover are shaped to receive at least a portion of the manifold assembly; optionally, the front panel is shaped to receive and retain the manifold assembly; optionally, the front panel includes a retaining element configured to engage with the manifold assembly, and optionally, retains the manifold assembly in a removable manner.

[0144] In aspect 105 according to aspect 103 or 104, when the manifold assembly is properly mounted on the circulator, the manifold assembly is closed between the front panel and the cover.

[0145] In aspect 106, according to any one of aspects 103 to 105 (when used with aspect 101), at least the connecting end of the air duct is mounted on the cover or front panel, and when the manifold assembly is properly mounted on the circulator, the connecting end is connected to the vent membrane of the housing.

[0146] In aspect 107, according to any one of aspects 103 to 106 (when used with aspect 96), the at least one level sensor is mounted on the front panel or cover.

[0147] In aspect 108, according to any one of aspects 103 to 106 (when used in conjunction with aspects 24 and 29), the blocking element is mounted on the front panel or cover.

[0148] In aspect 109, according to one or more of aspects 93 to 108, the circulator includes a control unit, a motor of a peristaltic pump, and an actuator of a occlusion element; wherein the control unit is operatively connected to the motor, the actuator, a pressure transducer and / or an air pump, and at least one level sensor, optionally connected to a displacement sensor; wherein the control unit is configured / programmed to control the operation of the peritoneal dialysis device.

[0149] In aspect 110, according to aspect 3 or aspect 109 (when used with aspect 99), the method includes the steps of 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 direction of rotation to pump fluid from the first compartment to the second compartment, thereby transferring dialysis fluid from the first supply bag to the patient.

[0150] In aspect 111 of aspect 3 or aspect 109 (when used with aspect 99), the method includes the steps of 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 direction of rotation to pump fluid from a first compartment to a second compartment, thereby moving dialysis fluid from a first supply bag to a heating bag.

[0151] In aspect 112 of aspect 3 or aspect 109 (when used with aspect 99), the method includes the steps of: 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 a second rotational direction to pump fluid from the second compartment to the first compartment, thereby moving dialysis fluid from the first supply bag to the heating bag.

[0152] In aspect 113 of aspect 3 or aspect 109 (when used with aspect 99), the method includes the steps of: 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 direction of rotation to pump fluid from the first compartment to the second compartment, thereby transferring heated dialysis fluid from the heating bag to the patient.

[0153] In aspect 114 of aspect 3 or aspect 109 (when used with aspect 99), the method includes the steps of opening the drain valve and the patient valve; closing the heater valve, 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, thereby moving used dialysis fluid from the patient to the drain.

[0154] In aspect 115 according to aspect 3 or aspect 109 (when used with aspect 99), the method includes the steps of opening a bypass valve and a drain valve; closing a heater valve, a patient valve, a first dialysis valve, and a second dialysis valve; rotating a peristaltic pump in a second rotational direction to pump pre-fill fluid from the second compartment to the first compartment and from the heating bag to the drain section, and performing the pre-filling step.

[0155] In aspect 116 of aspect 3 or aspect 109 (when used with aspect 99), the method includes the steps of: opening the heater valve and the auxiliary drain valve; closing the patient valve, the first dialysis valve, the second dialysis valve, and the drain valve; rotating the peristaltic pump in a first rotational direction to pump pre-filled fluid from the first compartment to the second compartment and from the heating bag to the drain section, and performing the pre-filling step.

[0156] In aspect 117 of aspect 3 or aspect 109 (when used with aspect 99), the method includes the steps of opening a first dialysis valve; closing a bypass valve, a heater valve, a patient valve, a second dialysis valve, and a drain valve; and rotating a peristaltic pump in a first rotational direction to pump pre-fill fluid from the first compartment to the second compartment and from the first supply bag to the expansion chamber to perform the pre-filling step.

[0157] In aspect 118 of aspect 3 or aspect 109 (when used with aspect 99), the method includes the steps of opening a drain valve; closing a bypass valve, a heater valve, a patient valve, a second dialysis valve, and a first dialysis valve; and rotating a peristaltic pump in a second rotational direction to pump pre-fill fluid from the second compartment to the first compartment and from the expansion chamber to the drain section to perform the pre-filling step.

[0158] In aspect 119 of aspect 3 or aspect 109 (when used with aspect 99), the method includes the steps of opening a second dialysis valve; closing a bypass valve, a heater valve, a patient valve, a drain valve, and a first dialysis valve; and rotating a peristaltic pump in a first rotational direction to pump pre-fill fluid from a first compartment to a second compartment and from a second supply bag to an expansion chamber to perform the pre-filling step.

[0159] In aspect 120, according to aspect 3 or aspect 109 (when used with aspect 99), the method includes the steps of opening a first dialysis valve and a drain valve; closing a bypass valve, a heater valve, a patient valve, and a second dialysis valve; rotating a peristaltic pump in a second rotational direction to pump pre-filled fluid from a second compartment to a first compartment and from a first supply bag to a drain section, and performing a pre-filling step.

[0160] In aspect 121 of aspect 3 or aspect 109 (when used with aspect 99), the method includes the steps of opening a second dialysis valve and a drain valve; closing a bypass valve, a heater valve, a patient valve, and a first dialysis valve; rotating a peristaltic pump in a second rotational direction to pump pre-filled fluid from the second compartment to the first compartment and from the second supply bag to the drain section, and performing the pre-filling step.

[0161] In aspect 122 of aspect 3 or aspect 109 (when used with aspect 99), the method includes the steps of opening a heater valve and a patient valve; closing a bypass valve, a first dialysis valve, a drain valve, and a second dialysis valve; rotating a peristaltic pump in a first rotational direction to pump pre-filled fluid from a first compartment to a second compartment and from a heated bag to the patient, and performing the pre-filling step.

[0162] In aspect 123, according to aspect 3 or aspect 109 (when used with aspect 99), the method includes the steps of opening a heater valve, a patient valve, a bypass valve, a first dialysis valve, a drain valve, and a second dialysis valve; opening the output pump tubing and performing a pre-filling step.

[0163] Aspect 124 may also be independent, relating to a manifold assembly for a dialysis device, wherein the manifold assembly includes: a housing comprising a rigid outer shell and at least one diaphragm defining at least a first fluid channel; the rigid outer shell including at least one port in fluid communication with the first fluid channel and a second fluid channel; the at least one port having a seat; the at least one diaphragm facing the seat of the at least one port; the seat being configured to at least partially receive a corresponding occlusion element of the dialysis machine.

[0164] A 125 aspect relates to a dialysis apparatus comprising a dialysis machine and a manifold assembly of aspect 124, wherein the manifold assembly is mounted on or can be mounted on the dialysis machine; the dialysis machine includes at least one occlusion element; when the manifold assembly is properly mounted on the dialysis apparatus, the occlusion element faces a seat with a diaphragm located therebetween; optionally, the dialysis apparatus is an apparatus for extracorporeal blood processing; optionally, the apparatus for extracorporeal blood processing includes: a blood processing device; an extracorporeal blood circuit coupled to the blood processing device; a blood pump, a pump section of the extracorporeal blood circuit configured to be coupled to the blood pump; optionally, a treatment fluid circuit operatively connected to the extracorporeal blood circuit and / or the blood processing device; optionally, the treatment fluid circuit includes a dialysis line coupled to a fluid chamber of a treatment unit, and optionally a fluid discharge line coupled to the fluid chamber; optionally, the treatment fluid circuit includes an injection circuit including one or more injection lines for replacement fluid; wherein the manifold assembly may be part of the extracorporeal blood circuit or the treatment fluid circuit.

[0165] In aspect 126, according to any one of aspects 24, 25, 29, 30, 35, 36, 40, 41, 45, 46, 51, 52, 91, 92, 98, 99, 108, 109, and 125, the blocking element comprises a plunger and an actuator; wherein the actuator is configured to move the plunger between a retracted position and an advanced position, in which the plunger is spaced apart from the diaphragm and the port is open, and in the advanced position, the plunger is at least partially received in the seat, and the diaphragm is confined between the plunger and the seat to close the port; optionally, the actuator is a stepper motor or a linear actuator.

[0166] In aspect 127 of 126, the diaphragm is configured to close the port by deformation of the plunger when the plunger is at least partially received in the seat.

[0167] In aspect 128 of aspect 127, the seat includes an edge, optionally a rounded edge, and the diaphragm is constrained between the plunger and the edge when the plunger is at least partially received in the seat.

[0168] In aspect 129 according to aspect 126 or 127 or 128, the occlusion element includes a membrane tensioner configured to lift the diaphragm away from the seat when the plunger returns to the retracted position and to counteract any possible negative pressure that tends to keep the port closed; optionally, the membrane tensioner is of the mechanical type.

[0169] In aspect 130 of aspect 129, the membrane tensioner includes a tensioning plunger connected to an actuator or auxiliary actuator of a plunger; wherein the actuator or auxiliary actuator is configured to move the tensioning plunger between a retracted position and an advanced position, in the retracted position the tensioning plunger being spaced apart from the diaphragm, and in the advanced position the tensioning plunger engaging the diaphragm at a position other than the seat (optionally other than the edge) to remove the diaphragm from the seat and stretch the diaphragm over the seat; optionally, the tensioning plunger is positioned about the plunger; optionally, the tensioning plunger includes a generally cylindrical wall; optionally, the tensioning plunger is coaxial with the plunger.

[0170] In aspect 131 of aspect 130, the tensioning plunger includes at least one arched wall, optionally including multiple arched walls; wherein at least one window is defined by the arched wall, or multiple windows are defined between the arched walls; optionally, the tensioning plunger includes two arched walls and two windows.

[0171] In aspect 132 according to aspect 130 or 131, when the plunger is in the forward position, the tensioning plunger is in the retracted position, and when the plunger is in the retracted position, the tensioning plunger is in the forward position.

[0172] In aspect 133 according to aspect 130, 131, or 132, the blocking element includes a shaft having a distal end that carries a plunger; a tensioning plunger is mounted on the shaft and is axially movable along the shaft; optionally, the tensioning plunger is coaxial with the shaft; optionally, an actuator is connected to the shaft to move the shaft.

[0173] In aspect 134 according to any of aspects 130 to 133, a location other than the edge includes an auxiliary edge spaced apart from the edge, wherein the auxiliary edge rises relative to the edge and extends partially around the seat to keep the port open when the tensioning plunger is in the forward position; optionally, the auxiliary edge is arched or includes at least one arched portion, optionally including a plurality of arched portions, wherein at least one radial opening is defined by the arched portion, or a plurality of radial openings are defined between the arched portions.

[0174] In aspect 135 according to any of aspects 130 to 134, the port includes a shaped member projecting from the bottom surface of a rigid housing, wherein a seat is formed in said shaped member.

[0175] In aspect 136 of aspect 135, the forming member includes an edge and an auxiliary edge.

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

[0177] In aspect 138, according to any of aspects 135 to 137, the forming member defines a central cavity, wherein an edge defines the upper part of the central cavity.

[0178] In aspect 139 of aspect 134, when the tensioning plunger is in the forward position, the wall or multiple walls of the tensioning plunger are positioned close to the auxiliary edge.

[0179] In aspect 140 of aspect 135, when the tensioning plunger is in the forward position, the forming member is at least partially located inside the tensioning plunger, and the wall or plurality of walls of the tensioning plunger surrounds the auxiliary edge.

[0180] In aspect 141 according to aspects 131 and 134, when the tensioning plunger is in the forward position, at least one arched wall of the tensioning plunger is positioned near at least one arched portion of the auxiliary edge such that at least one window faces at least one radial opening; alternatively, each arched wall of the tensioning plunger is radially positioned outside the corresponding arched portion of the auxiliary edge such that each window faces the corresponding radial opening.

[0181] In aspect 142, based on aspects 131 and 134, the number of arched sections and arched walls are equal.

[0182] In aspect 143 according to any of aspects 130 to 142, the blocking element includes a reversing mechanism connecting the tensioning plunger and the plunger, wherein the reversing mechanism is configured to move the plunger in the opposite direction to the direction of movement of the tensioning plunger when the plunger or the tensioning plunger is moved by the actuator.

[0183] In aspect 144 of aspect 143, the reversing mechanism includes a rocker arm hinged to a plunger, a tensioning plunger, and a fixed part of a dialysis machine or circulator, such that when the shaft moves axially in a second direction opposite to the first direction, the tensioning plunger moves axially in the first direction; optionally, the rocker arm is hinged to the shaft of the plunger.

[0184] In aspect 145 according to aspect 144, the first end of the rocker arm is hinged to a plunger, optionally hinged to a shaft, the second end of the rocker arm is hinged to a tensioning plunger, and the middle portion of the rocker arm is hinged to a fixed part.

[0185] In aspect 146 of aspect 143, the reversing mechanism includes a threaded connection between a shaft and a tensioning plunger, such that when the shaft moves axially in a second direction opposite to the first direction, the tensioning plunger moves axially in the first direction.

[0186] In aspect 147 of aspect 146, the motor includes a rotatable shaft, and the rotatable shaft is connected to the shaft of the plunger via a threaded coupling; the threaded connection between the shaft and the tensioning plunger is a left-hand thread, and the threaded connection between the rotatable shaft and the shaft is a right-hand thread (or vice versa).

[0187] In aspect 148 according to any of aspects 126 to 147, the blocking element includes a damping and / or elastic element coupled to the plunger; optionally, the damping and / or elastic element is positioned between the distal end of the shaft carrying the plunger and the plunger.

[0188] The 149th aspect relates to a method for calibrating a peristaltic pump in a dialysis device, the dialysis device being optionally a peritoneal dialysis device or a device for extracorporeal blood processing; wherein the dialysis device includes a dialysis machine or circulator according to one or more of the foregoing or following aspects, and a manifold assembly according to one or more of the foregoing or following aspects.

[0189] The 150th aspect relates to a dialysis apparatus, optionally a peritoneal dialysis apparatus or an apparatus for extracorporeal blood processing, comprising a dialysis machine or circulator according to one or more of the foregoing or following aspects, and a manifold assembly according to one or more of the foregoing or following aspects; wherein the control unit of the dialysis machine or circulator is at least operatively connected to a peristaltic pump and a pressure transducer, and is configured and / or programmed to calibrate the peristaltic pump.

[0190] In aspect 151 according to aspect 149 or 150, the method includes the following steps or the control unit is configured and / or programmed to perform the following steps:

[0191] i. Rotate the peristaltic pump a predetermined number of times to pump liquid from the fluid source into the second compartment and raise the liquid level in the second compartment to compress the air in the air buffer volume;

[0192] ii. Measure the air pressure in the air buffer volume;

[0193] iii. Calculate the change in liquid volume in the second compartment due to the rotation of the peristaltic pump, based on the measured air pressure in the air buffer volume;

[0194] iv. Calculate the peristaltic pump's stroke liquid volume based on the change in liquid volume and the predetermined rotation.

[0195] In aspect 152 of aspect 151, rotating the peristaltic pump a predetermined number of times includes rotating the peristaltic pump multiple times such that the pressure clamping element of the peristaltic pump or one of the plurality of pressure clamping elements of the peristaltic pump is in the same predetermined position at the beginning and end of rotation.

[0196] In aspect 153 of aspect 152, the peristaltic pump includes an encoder operatively connected to the control unit to detect the position and movement of one or more clamping elements of the peristaltic pump.

[0197] In aspect 154 of aspect 153, the control unit is configured and / or programmed to detect a predetermined position via an encoder.

[0198] In aspect 155, according to any one of aspects 151 to 154, the peristaltic pump includes two clamping elements spaced 180° apart, and the predetermined rotation includes “n” half-turns of the peristaltic pump; optionally, “n” is an integer between 5 and 10; optionally, the rotational speed of the peristaltic pump is between 3 rpm and 8 rpm.

[0199] In aspect 156, according to any one of aspects 150 to 155, the output pump tube is shaped into a ring comprising a circular portion and two straight portions, wherein a clamping element presses the circular portion during rotation.

[0200] In aspect 157 according to aspect 156 (when according to aspect 152), the predetermined position is located or near the portion between the round portion and one of the two straight portions.

[0201] In aspect 158, according to any one of aspects 151 to 157, measuring the air pressure in the air buffer volume includes: measuring the initial pressure before air compression and measuring the final pressure after air compression.

[0202] In aspect 159 of aspect 158, the initial pressure is approximately 0 mmHg.

[0203] In aspect 160, according to aspect 158 ​​or 159, the final pressure is approximately 400 mmHg.

[0204] In aspect 161, according to any one of aspects 151 to 160, the liquid level rises from a first liquid level; wherein, at the end of a predetermined rotation, the liquid is at a second liquid level.

[0205] In aspect 162 of aspect 161 (when according to any of aspects 158 to 159), the change in liquid volume is calculated based on the initial air volume above the first liquid level, as well as the initial pressure and the final pressure.

[0206] In aspect 163, according to aspects 162 and 155, the stroke fluid volume is the ratio between the change in fluid volume and the number of half revolutions of the peristaltic pump contained in a predetermined rotation.

[0207] In aspect 164 according to any one of aspects 161 to 163 and aspect 96, the at least one liquid level sensor includes a low liquid level sensor, and a first liquid level is obtained by rotating a peristaltic pump until a low liquid level is sensed by the low liquid level sensor, and by further rotating the peristaltic pump by a predetermined angle to pump an additional volume of liquid above the low liquid level in a second compartment.

[0208] In a second aspect of aspect 164, rotating the peristaltic pump until a low liquid level is sensed includes: rotating the peristaltic pump in a first rotation direction to pump fluid from a first compartment to a second compartment until a low liquid level is sensed for the first time and the peristaltic pump is stopped; rotating the peristaltic pump in a second rotation direction to bring the liquid level below the low liquid level and stopping the peristaltic pump; rotating the peristaltic pump again in the first rotation direction to reach the low liquid level again, and continuing to rotate the peristaltic pump to pump an additional volume of liquid.

[0209] In aspect 165 according to aspects 164 and 152, the predetermined position of the clamping element is the position at the end of a further predetermined rotation angle; optionally, the control unit is configured and / or programmed to set the predetermined position of the clamping element to the position at the end of a further predetermined rotation angle, and the peristaltic pump starts rotating the predetermined circle from the predetermined position of the clamping element corresponding to the first liquid level; optionally, an air valve connected to the air buffer volume opens before reaching the predetermined position and closes once the predetermined position is reached, and closes the air valve during subsequent compression.

[0210] In aspect 166 according to aspect 164 or 165, the first liquid level is the liquid level reached at the end of a further predetermined rotation angle.

[0211] In aspect 167, which is based on any of aspects 164 to 166, the predetermined angle is between 90° and 120°.

[0212] In aspect 168, according to any of aspects 164 to 167, a first volume is defined in a second compartment below the low liquid level sensor; optionally, the first volume is between 5 ml and 15 ml.

[0213] In aspect 169, which is based on any of aspects 164 to 168 and aspect 162 or 163, the initial air volume is the difference between the air volume above the low liquid level and the additional liquid volume.

[0214] In aspect 170 of any of aspect 165 or 166 to 169 (when according to aspect 165), the at least one level sensor includes a high level sensor, and a high level is sensed by the high level sensor, and after the high level is sensed, the rotation of the peristaltic pump is stopped when the clamping element is first in a predetermined position.

[0215] In aspect 171 of 170, a second volume is defined in a second compartment between the low-level sensor and the high-level sensor.

[0216] In aspect 172 of aspect 171, the second volume is between two and four times the rated stroke liquid volume of the peristaltic pump, optionally between 15 ml and 25 ml.

[0217] In aspect 173 of aspect 172, a third volume is defined in a second compartment above the high liquid level sensor.

[0218] In aspect 174 of aspect 173, the third volume is between 10 ml and 20 ml.

[0219] In aspect 175 according to any of aspects 170 to 174, the method includes the following steps or the control unit is configured and / or programmed to perform the following steps: after stopping the rotation of the peristaltic pump and before obtaining the final pressure, waiting for a settling time and continuing to measure the pressure to check for possible leaks.

[0220] In aspect 176, according to aspect 150 or any of aspects 151 to 175 (when according to aspect 150), the housing includes a breathable membrane configured to cause the pressure transducer to communicate with an air buffer volume.

[0221] In aspect 177 of aspect 176, the dialysis machine or circulator further includes an auxiliary chamber that is in fluid communication with an air buffer volume via a permeable membrane and with a pressure transducer.

[0222] In aspect 178 of aspect 177, the fourth volume of the auxiliary chamber is between 20 ml and 30 ml; alternatively, the sum of the second, third and fourth volumes is between 50 ml and 70 ml.

[0223] In aspect 179 according to any of aspects 151 to 178, the stroke liquid volume is calculated multiple times consecutively through steps i to iv, optionally 2 to 5 times, and the average stroke liquid volume is determined.

[0224] At least one expansion chamber configured to reduce pressure pulsations from the peristaltic pump reduces the peristaltic effect of the pump, which has a positive impact on patient comfort.

[0225] The presence of an air buffer volume ensures that any air bubbles that may be present in the solution are removed before administration to the patient.

[0226] The connection between the air buffer volume and the pressure transducer allows monitoring of the pressure value in the second compartment connected to the patient tubing, and has a context interface with an air pump that can adjust the liquid level in the second compartment based on feedback provided by a liquid level sensor.

[0227] The soft plastic plate, which interfaces with the displacement sensor of the circulator, allows for the detection of extreme negative pressure values ​​that may occur in the first compartment connected to the discharge section and the heating bag.

[0228] The shape of the manifold assembly housing provides improved usability, characterized by a “one-handed first operating step” for mounting the device on the circulator.

[0229] The overall design of the manifold assembly is also compatible with users who want to interface with the circulator hardware components.

[0230] The structure of the housing and the port of the closure element of the circulator or dialysis machine ensures accurate and timely closing and opening of the valve.

[0231] The calibration of the output pump tubing connected to the peristaltic pump, as well as the components including the output pump tubing and the peristaltic pump, allows for precise and simple control of fluid flow and enhanced monitoring of the effectiveness of dialysis treatment. Attached Figure Description

[0232] FIG. 1 This is a perspective view of one embodiment of the automated peritoneal dialysis device (“APD”) disclosed herein;

[0233] FIG. 2 This is a front view of one embodiment of the manifold assembly of the APD device disclosed herein;

[0234] FIG. 3 yes FIG. 2 Rear view of the manifold assembly, with some parts removed to show the interior, and some other parts schematically shown;

[0235] FIG. 4 yes FIG. 2 Side view of the manifold assembly;

[0236] FIG. 5 yes FIG. 4 A schematic cross-sectional view of a portion of the side view;

[0237] FIG. 6A and FIG. 6B It is along FIG. 3 A schematic cross-sectional view of another part of the component, taken by section line VI-VI;

[0238] FIG. 7 It is along FIG. 3 A schematic cross-sectional view of another part of the component, taken by section line VII-VII;

[0239] FIG. 8 to FIG. 11 It shows FIG. 3 The rear view shows the corresponding construction of the manifold assembly and the associated fluid flow path;

[0240] FIG. 12 to FIG. 15 It shows FIG. 8 to FIG. 11 The configuration flowchart;

[0241] FIG. 16 A rear view of another embodiment of the manifold assembly is shown, in which some components have been removed to show the interior, and some other components are schematically shown;

[0242] FIG. 17 yes FIG. 16 The rear view shows the corresponding flow structure;

[0243] FIG. 18 It is shown FIG. 17 The configuration flowchart;

[0244] FIG. 19 This 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 schematically shown;

[0245] FIG. 20A , FIG. 20B and FIG. 20C It shows FIG. 16 , FIG. 17 and FIG. 18 Examples of valves in the embodiments;

[0246] FIG. 21A to FIG. 21D The components that mate with the circulator are shown. FIG. 20A The working steps of the valve;

[0247] FIG. 22 yes FIG. 21A Examples of the components;

[0248] FIG. 22A yes FIG. 22 Variations of the embodiments;

[0249] FIG. 23 It shows FIG. 21A Another embodiment of the element;

[0250] FIG. 24 It shows FIG. 22 or FIG. 23 Components of an element;

[0251] FIG. 25 yes FIG. 20A valve and FIG. 24 A schematic top view of the components;

[0252] FIG. 26 It shows FIG. 16 and FIG. 17 The manifold assembly is configured to perform a calibration method;

[0253] FIG. 27 It shows FIG. 26 Manifold assembly and liquid level in the manifold during calibration;

[0254] FIG. 28 It is a diagram illustrating the calibration method;

[0255] FIG. 29 This is a flowchart illustrating the calibration method. Detailed Implementation

[0256] Example 1

[0257] Now for reference FIG. 1 to FIG. 15 An embodiment of the peritoneal dialysis device 1 (APD) includes a circulator 2 and a manifold assembly 3 ( FIG. 2 and FIG. 3 The manifold assembly 3 organizes the tubing and performs many of the functions discussed herein.

[0258] The circulator 2 includes a housing 4 that contains all the mechanical and electronic components of the circulator 2. The circulator 2 includes an electronic control unit 5. FIG. 4 ), Roller peristaltic pump 6 ( FIG. 1 ), multiple blocking elements 7, a first or high level sensor 8 and a second or low level sensor 9, a pressure transducer 10 and an air pump 11 ( FIG. 4 (Illustrated schematically). Circulator 2 may also include a heater (not shown).

[0259] FIG. 3 and FIG. 25 The peristaltic pump shown includes two pressure rollers 6a spaced 180° apart.

[0260] The motor (not shown) of the peristaltic pump 6 is housed in the housing 4, and the rotor 12 of the peristaltic pump 6 is located on the front panel 13 of the housing 4. FIG. 1 ).

[0261] A portion 14 of the front panel 13 near the rotor 6 is configured to removably hold the manifold assembly 3 on the front panel 13. The portion 14 may include a retaining element configured to engage with the manifold assembly 3, and / or the manifold assembly 3 may include a hook element configured to removably hook the disposable assembly 3 onto the front panel 13 of the circulator 2.

[0262] Blocking element 7 ( FIG. 4 The occlusion element 7 protrudes from the front panel at location 14. Each occlusion element 7 includes a plunger 15 that is moved by a corresponding actuator (not shown) housed in the housing 4. FIG. 6A and FIG. 6B The actuator is configured to be in the retracted position. FIG. 6A ) and forward position ( FIG. 6B The piston 15 is moved between the two sides, which will be discussed in this article.

[0263] The circulator 2 includes a cover 16 that can move between a closed position and an open position. FIG. 1 and FIG. 4 In the closed position, cover 16 covers the front panel 13; in the open position, cover 16 is spaced apart from the front panel 13 to allow user access to the front panel 13. In the embodiment shown in the figures, cover 16 is hinged to the housing 4 and can rotate between the open and closed positions. For simplicity, the elements belonging to cover 16 detailed below are not listed in the figures. FIG. 1 As shown in the image.

[0264] When the manifold assembly 3 is properly installed on the portion 14 of the circulator 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.

[0265] The first liquid level sensor 8 and the second liquid level sensor 9 are mounted on the cover 16 and are configured to face the front panel 13 and / or manifold assembly 3 from the cover 16 when the cover 16 is in the closed position. FIG. 4 The sides of the liquid level sensors 8 and 9 are protruding. The illustrated liquid level sensors 8 and 9 are capacitive sensors. In other embodiments not shown in the figures, the liquid level sensors 8 and 9 may be ultrasonic sensors or other types of sensors, and / or may be mounted on the front panel of the housing 4.

[0266] An air duct 17 is mounted on the cover 16 and includes a coupling end 18. The coupling end 18 is configured to operate when the cover 16 is in the closed position. FIG. 4 and FIG. 5 The manifold assembly 3 is oriented towards the air duct 17, which will be discussed herein. The air duct 17 is in air communication with the pressure transducer 10 and the air pump 11. The pressure transducer 10 and the air pump 11 can be installed in the cover 16 or the housing 4.

[0267] FIG. 4 The control unit 5, schematically shown, is operatively 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 device or sensor of the circulator 2, and is configured / programmed to control the operation of the peritoneal dialysis device 1.

[0268] The control unit can also be connected to a display, keyboard, or touchscreen 100, configured to display the operating parameters of device 1 and / or allow users to set device 1's parameters. FIG. 1 ).

[0269] The cover 16 and / or front panel 13 of the housing 4 may also include other elements, not shown, configured to manage and arrange the piping of the manifold assembly 3.

[0270] The manifold assembly 3 for peritoneal dialysis device 1 includes a disposable housing 19, which comprises a rigidly molded plastic outer shell 20 made, for example, of a PETG (polyethylene terephthalate modified) polymer. FIG. 2 , FIG. 3 and FIG. 4 ) and, for example, plastic sheets 21 of polyvinyl chloride films. FIG. 4 A rigidly molded plastic housing 20 defines the front and sides of the housing 19, and a plastic sheet 21 forms the back of the housing 19. FIG. 4 ).

[0271] The rigid plastic housing 20 has a generally flat shape and includes partitions and recesses on the inner side of the housing 19. The partitions internally define a first compartment 22 and a second compartment 23 for fresh and waste dialysis fluids. FIG. 3 The recess defines three corresponding expansion chambers 24a, 24b, and 24c internally, and three corresponding protrusions 25a, 25b, and 25c externally on the front of the housing 19. FIG. 2 and FIG. 3 ).

[0272] In the front or rear view, the plastic rigid housing 20 and housing 19 have a generally rectangular outline with two long sides and two short sides. When housing 19 is properly mounted on circulator 2, the two long sides are vertical.

[0273] The first compartment 22 is defined by an outer diaphragm 26 and a first inner diaphragm 27 located on the outer perimeter of the rigid plastic housing 20. (See reference) FIG. 3 , FIG. 8 , FIG. 9 , FIG. 10 , FIG. 11 The rear view shows that the first inner diaphragm 27 has a first end connected to the outer diaphragm 26 on the top short side of the plastic rigid housing 20, and a second end connected to the outer diaphragm 26 on the right long side of the plastic rigid housing 20.

[0274] The first inner diaphragm 27 has a generally U-shaped shape and extends substantially parallel to the left long side, bottom short side, and right long side of the rigid plastic housing 20. The first compartment 22 is a U-shaped first elongated channel.

[0275] The second compartment 23 is defined by the portion of the first inner diaphragm 27 and the outer diaphragm 26 that does not define the first compartment 22, such that the second compartment 23 is surrounded by the U-shaped portion of the first compartment 22.

[0276] The second inner diaphragm 28 is located within the second compartment 23 to form a passage within the second compartment 23. The second inner diaphragm 28 has a first end connected to the first inner diaphragm 27 at a position near the first end of the first inner diaphragm 27, and a second free end positioned near the lower right corner of the plastic rigid housing 20.

[0277] refer to FIG. 3 , FIG. 8 , FIG. 9 , FIG. 10 , FIG. 11 In the rear view, the second inner diaphragm 28 has a generally inverted L-shape and extends substantially parallel to the top short side and right long side of the rigid plastic housing 20. Therefore, the second compartment 23 includes an inverted L-shaped second elongated channel.

[0278] The long section of the inverted L-shaped second elongated channel is parallel to the right long section of the U-shaped first elongated channel. The second compartment 23 includes a main central portion separated from the second elongated channel by a second inner diaphragm 28. The second elongated channel has a second end portion communicating with the main central portion.

[0279] Three expansion chambers 24a, 24b, and 24c are formed in the main center of the second compartment 23, and the depth of each expansion chamber 24a, 24b, and 24c is greater than the depth of the remaining part of the second compartment 23.

[0280] Two through holes 29a and 29b FIG. 2 and FIG. 3 The two through-holes pass through the main center of the rigid plastic housing 20 and the second compartment 23. These two through-holes are surrounded and defined by corresponding additional spacers 30 connected to the first inner diaphragm 27. Therefore, these additional spacers 30 also define the second compartment 23.

[0281] The first through hole 29a and the second through hole 29b are located between two of the three expansion chambers 24a, 24b, and 24c. The first expansion chamber 24a is located near the short side of the bottom of the housing 19 and the short section of the first elongated U-shaped channel; the second expansion chamber 24b is located between the first through hole 29a and the second through hole 29b; and the third expansion chamber 24c is positioned above the second through hole 29b.

[0282] The internal volume defined in the second compartment 23 is larger than the internal volume defined in the first compartment 22. For example, the internal volume of the second compartment 23 is approximately 55 m³. 3 The internal volume of the first compartment 22 is approximately 14m³. 3 .

[0283] Hole 31 ( FIG. 3 A rigid plastic shell 20 is formed on the front side of the plastic shell 20 located between the third expansion chamber 24c and the second inner diaphragm 28. A support breathable membrane 33 is also present. FIG. 2 The rigid plastic frame 32 is connected to the edge of the hole 31 by welding or bonding. The breathable membrane 33 may be PTFE (polytetrafluoroethylene).

[0284] When component 3 is properly installed on circulator 2, the upper part of the second compartment 23, which is provided with breathable membrane 33, defines the air buffer volume, which will be discussed herein.

[0285] Plastic sheet 21 ( FIG. 4 It is welded or bonded to the rigid plastic housing 20. The plastic plate 21 is connected to the outer diaphragm 26, the first inner diaphragm 27, the second inner diaphragm 28 and other spacers 30 to seal the first compartment 22 and the second compartment 23.

[0286] The rigid plastic housing 20 includes a first pump port 34, which is located on the right side of the housing 19 (in...). FIG. 3 and FIG. 8 to FIG. 11 A protruding hollow cylinder. The first pump port 34 is in fluid communication with the first compartment 22. The first pump port 34 opens at the end of the long right section of the first elongated U-shaped channel inside the first compartment 22.

[0287] The rigid plastic housing 20 includes a second pump port 35, which is located on the right side of the housing 19 (in...). FIG. 3 and FIG. 7 to FIG. 10 A protruding hollow cylinder. The second pump port 35 is in fluid communication with the second compartment 23. The second pump port 35 opens inside the second compartment 23 at the first end of the second elongated channel.

[0288] The first pump port 34 and the second pump port 35 are close to each other but separated by the first inner diaphragm 27. The hollow cylinders defining the first pump port 34 and the second pump port 35 are separated from each other away from the housing 19.

[0289] The rigid plastic housing 20 includes a discharge port 36, which is located on the left side of the housing 19. FIG. 3 and FIG. 7 to FIG. 10 (Middle) Protruding hollow cylinder 37.

[0290] The hollow cylinder 37 of the discharge port 36 passes through the outer diaphragm 26, so that the discharge port 36 is in fluid communication with the first compartment 22.

[0291] The discharge port 36 includes a short hollow cylinder 38 connected to a hollow cylinder 37. The central axis of the hollow cylinder 37 is perpendicular to the main axis of the hollow cylinder 38, and the cavities defined inside the hollow cylinder 37 and the hollow cylinder 38 are in fluid communication with each other. The hollow cylinder 38 protrudes from the bottom surface of the first compartment 22 and has an opening inside the first compartment 22. FIG. 6A and FIG. 6B ).

[0292] Hollow cylinder 38 compared to adjacent outer diaphragm 26 (e.g.) FIG. 6A and FIG. 6B (As shown), shorter than the first inner diaphragm 27, shorter than the second inner diaphragm 28, and shorter than the other spacer 30, such that when the plastic sheet 21 is not deformed, the plastic sheet 21 is separated from the edge of the hollow cylinder 38, as shown. FIG. 6A As shown.

[0293] As discussed herein, the edge of the hollow cylinder 38 and the portion of the plastic sheet 21 facing the edge form the discharge valve 39 of the discharge port 36.

[0294] The rigid plastic housing 20 also includes a first dialysis port 40 and a second dialysis port 41. Each of these ports 40, 41 is located on the left side of the housing 19. FIG. 3 and FIG. 7 to FIG. 10 The central part is prominent and has the same structure as the exhaust port 36 detailed above (hollow cylinder 37 and hollow tube 38).

[0295] The first dialysis port 40 and the second dialysis port 41 have a first dialysis valve 42 and a corresponding second dialysis valve 43 that can be accommodated.

[0296] The rigid plastic housing 20 also includes a heater port 44, which is also located on the left side of the housing 19 (in FIG. 3 and FIG. 7 to FIG. 10 The heater port 44 protrudes from the center and is structurally similar to the exhaust port 36 (hollow cylinder 37 and hollow tube 38) detailed above. The heater port 44 has a heater valve 45. The heater port 44 is located near the upper left corner of the plastic rigid housing 20.

[0297] Unlike the discharge port 36, the first dialysis port 40, and the second dialysis port 41, the hollow cylinder 38 of the heater port 44 is also in fluid communication with the opening 46 formed through the front of the housing 19. FIG. 7 ).

[0298] The rigid plastic housing 20 includes another hollow cylinder 47, which is placed in the second compartment 23 and near the heater port 44. A first inner diaphragm 27 is located between the other hollow cylinder 47 and the hollow cylinder 38.

[0299] Another hollow cylinder 47 is in fluid communication with another opening 48 formed through the front of the shell 19. FIG. 7 Furthermore, opening 46 and another opening 48 are connected by a bypass channel 49, which is defined by a cover 50 welded or bonded to the front of the rigid plastic housing 20. The bypass channel 49 is in fluid communication with the first compartment 22, the second compartment 23, and the heater conduit 63.

[0300] The edge of another hollow cylinder 47 and the portion of the plastic sheet 21 facing the edge form a bypass valve 51. The other hollow cylinder 47 is part of a bypass port 52 on which the bypass valve 51 is provided.

[0301] The second inner diaphragm 28 separates the area of ​​the second compartment 23 with the holes 31 and the breathable membrane 33 from the bypass valve 51. FIG. 3 and FIG. 8 ).

[0302] The rigid plastic housing 20 also includes a patient port 53. The patient port 53 is located on the left side of the housing 19 (on...). FIG. 3 and FIG. 7 to FIG. 10 The central part is prominent and has the same structure as the exhaust port 36 detailed above (hollow cylinder 37 and hollow tube 38).

[0303] The hollow cylinder 37 of the patient port 53 passes through the outer diaphragm 26 and the first inner diaphragm 27, thereby enabling fluid communication between the patient port 53 and the second compartment 23. FIG. 3 Patient port 53 has patient valve 54.

[0304] All valves (discharge valve 39, first dialysis valve 42, second dialysis valve 43, heater valve 45, bypass valve 51, patient valve 54) are identical in structure and function, and each is positioned in front of a corresponding occlusion element 7 of the circulator 2 when the manifold assembly 3 is properly mounted on the circulator 2. Each occlusion element 7 of the circulator 2 is configured to open or close a corresponding valve ( FIG. 6A and FIG. 6B In other embodiments not shown in the accompanying drawings, the occlusion element 7 may be mounted on the cover 16, and the structure of the manifold assembly 3 may cooperate with the occlusion element 7 on the cover 16.

[0305] The hollow cylinders 37 of the heater port 44, the first dialysis port 40, the second dialysis port 41, the discharge port 36, and the patient port 53 are parallel to each other. In the embodiment shown in the figures, when the manifold assembly 3 is properly mounted on the circulator 2, the heater port 44 is above the first dialysis port 40, which in turn is above the second dialysis port 41, which in turn is above the discharge port 36, which in turn is above the patient port 53.

[0306] A first compartment 22, shaped like a U-shape, extends between a first end of a first elongated channel and a first end of a first pump port 34. A second elongated channel has a first end connected to a second pump port 35.

[0307] Manifold assembly 3 includes a product pump tube 55 having a first end 56 connected to a first pump port 34 and a first compartment 22, and a second end 57 connected to a second pump port 35 and a second compartment 23. FIG. 1 The output pump tube 55 extends to the outside of the housing 19 and is shaped as an "Ω"-shaped ring or eyelet to partially surround the rotor 12 of the peristaltic pump 6 of the circulator 2.

[0308] Manifold assembly 3 also includes ( FIG. 3 The patient tubing 58 has a first end connected to the patient port 53 and a second end connected to the patient's peritoneal cavity; the first dialysis fluid tubing 59 has a first end connected to the first dialysis port 40 and a second end connected to the first supply bag 60; the second dialysis fluid tubing 61 has a first end connected to the second dialysis port 41 and a second end connected to the second supply bag 62; the heater tubing 63 has a first end connected to the heater port 44 and a second end connected to the heating bag 64; and the discharge fluid tubing 65 has a first end connected to the discharge port 36 and a second end connected to the discharge section 66.

[0309] The patient tubing 58 can extend to a patient tubing connector, which can, for example, be connected to a patient's transmission device leading to an indwelling catheter extending into the patient's peritoneal cavity.

[0310] The first compartment 22, the output pump line 55, and the second compartment 23 together define a fluid path extending between one of the first dialysis fluid line 59, the second dialysis fluid line 61, the heater line 63, the discharge fluid line 65, and the patient line 58, to allow fluid to flow from one of the fluid lines to the patient line 58 or from the patient line 58 to one of the fluid lines when the peristaltic pump 6 of the circulator 2 is activated.

[0311] The housing 19 of the manifold assembly 3 is mounted on the front panel 13 of the circulator 2. The output pump line 55 is connected to the rotor 12, and the first dialysis fluid line 59, the second dialysis fluid line 61, the heater line 63, and the discharge fluid line 65 are appropriately arranged and connected to the corresponding first supply bag 60, second supply bag 62, heating bag 64, and discharge section 66. The patient line 58 is appropriately arranged and connected to the patient P. The heating bag 64 is connected to the heater of the circulator 2.

[0312] The housing 19, which has three protrusions 25a, 25b, 25c and two through holes 29a, 29b, is shaped to facilitate the user's grip on the housing 19 and to mount the housing 19 onto the circulator 2.

[0313] The user closes the cover 16, causing the first liquid level sensor 8 and the second liquid level sensor 9 to be positioned in front of the flat outer surface of the housing 19. When the cover 16 is closed, the positions of the first liquid level sensor 8 and the second liquid level sensor 9 are as follows: FIG. 2 and FIG. 4 As shown in [the image]. FIG. 2 In the diagram, the positions of the first liquid level sensor 8 and the second liquid level sensor 9 are schematically represented by dashed circles.

[0314] The first liquid level sensor 8 and the second liquid level sensor 9 are positioned such that one is on top of the other. The first liquid level sensor 8 is located between the third expansion chamber 24c and the second expansion chamber 24b. The second liquid level sensor 9 is located between the second expansion chamber 24b and the first expansion chamber 24a.

[0315] When the cover 16 is closed, the connecting end 18 of the air duct 17 is connected to the rigid plastic frame 32 that supports the breathable membrane 33. FIG. 4 and FIG. 5 This causes the connecting end 18 to face the breathable membrane 33. In this way, the pressure transducer 10 and the air pump 11 of the circulator 2 are connected to the breathable membrane 33 and the upper part (i.e., the air buffer volume) of the second compartment 23.

[0316] According to the method for controlling the peritoneal dialysis device 1, the control unit 5 commands the actuator of the occlusion element 7 to open or close the discharge 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.

[0317] When the valve 54 of the patient port 53 is open, the patient tubing 58 is in fluid communication with the second compartment 23. When the valve 54 of the patient port 53 is closed, the fluid communication between the patient tubing 58 and the second compartment 23 is blocked.

[0318] When the first dialysis valve 42 of the first dialysis fluid port 40 is opened, the first dialysis fluid line 59 is in fluid communication with the first compartment 22. When the first dialysis valve 42 of the first dialysis fluid port 40 is closed, the fluid communication between the first dialysis fluid line 59 and the first compartment 22 is blocked.

[0319] When the second dialysis valve 43 of the second dialysis fluid port 41 is opened, the second dialysis fluid line 61 is in fluid communication with the first compartment 22. When the second dialysis valve 43 of the second dialysis fluid port 41 is closed, the fluid communication between the second dialysis fluid line 61 and the first compartment 22 is blocked.

[0320] When the heater valve 45 at heater port 44 is open, the heater line 63 is in fluid communication with the first compartment 22. When the heater valve 45 at heater port 44 is closed, the fluid communication between the heater line 63 and the first compartment 22 is blocked.

[0321] When the discharge valve 39 of the discharge port 36 is open, the discharge fluid line 65 is in fluid communication with the first compartment 22. When the discharge valve 39 of the discharge port 36 is closed, the fluid communication between the fluid discharge line 65 and the first compartment 22 is blocked.

[0322] When the bypass valve 51 of the bypass port 52 is open, the heater line 63 is in fluid communication with the second compartment 23; when the bypass valve 51 of the bypass port 52 is closed, the fluid communication between the heater line 63 and the second compartment 23 is blocked.

[0323] like FIG. 6A , FIG. 6B and FIG. 7 As shown, when the actuator holds the plunger 15 of the blocking element 7 in place... FIG. 6A When in the retracted position, the plastic sheet 21 is separated from the edge of the hollow cylinder 38, and fluid can flow between the hollow cylinder 38 and the first compartment 22 (valve open).

[0324] When the actuator moves the plunger 15 of the blocking element 7 to FIG. 6B When the plunger 15 is in the forward position and held in the forward position, the plunger 15 is partially housed in the hollow cylinder 38.

[0325] The plunger 15 pushes a portion of the plastic sheet 21, deforming it and holding it against the edge of the hollow cylinder 38. The hollow cylinder 38 serves as a seat for the plunger 15 and the portion of the plastic sheet 21 sandwiched therebetween. Fluid flow between the hollow cylinder 38 and the first compartment 22 is blocked (valve closed). All valves operate in this manner.

[0326] Prefill manifold assembly 3 before patient treatment. The following table (Table 1) lists the possible prefilling sequences.

[0327] Table 1

[0328]

[0329]

[0330] Another pre-charge process can be performed using the connected containers disclosed in Table 2 below.

[0331] Table 2

[0332]

[0333] After pre-filling, patient treatment can begin.

[0334] According to an embodiment of the method for controlling peritoneal dialysis device 1 ( FIG. 8 and FIG. 12 The control unit 5 commands the peritoneal dialysis device 1 to move the dialysis fluid from the first supply bag 60 to the patient P.

[0335] Control unit 5 closes and maintains the closed heater valve 45, bypass valve 51, second dialysis valve 43, and drain valve 39, and opens and maintains the open first dialysis valve 42 and patient valve 54. Control unit 5 commands the motor to rotate in the first direction ( FIG. 8 The peristaltic pump 6 is rotated counterclockwise to pump dialysis fluid from the first compartment 22 to the second compartment 23.

[0336] An auxiliary online heater (not shown) may be placed on the first dialysis fluid line 59 to heat the dialysis fluid as it flows through the dialysis fluid line 59 and toward the patient P.

[0337] According to another embodiment of the method for controlling peritoneal dialysis device 1 ( FIG. 9 , FIG. 10 , FIG. 11 , FIG. 13 , FIG. 14 , FIG. 15 The control unit 5 commands the peritoneal dialysis device 1 to move the dialysis fluid from the first supply bag 60 to the heating bag 64. In this embodiment, an auxiliary online heater is not used.

[0338] Control unit 5 opens and maintains the open bypass valve 51 and the first dialysis valve 42, while simultaneously closing and maintaining the closed heater valve 45, the second dialysis valve 43, the drain valve 39, and the patient valve 54. Control unit 5 commands the motor to rotate in the first direction ( FIG. 9 The peristaltic pump 6 is rotated counterclockwise to pump dialysis fluid from the first compartment 22 to the second compartment 23, and then through the bypass channel 49 to the heating bag 64.

[0339] Once the dialysis fluid is heated in the heating bag 64 connected to the heater of the circulator 2, the control unit 5 commands the peritoneal dialysis device 1 to transfer the heated dialysis fluid from the heating bag 64 to the patient P.

[0340] Control unit 5 opens and maintains the open heater valve 45 and patient valve 54, and closes and maintains the closed bypass valve 51, first dialysis valve 42, second dialysis valve 43, and drain valve 39. Control unit 5 commands the motor to rotate in a first direction ( FIG. 10 The peristaltic pump 6 is rotated counterclockwise to pump dialysis fluid from the first compartment 22 to the second compartment 23.

[0341] At the end of the patient's treatment, the waste dialysis fluid is removed from the patient P's body. The control unit 5 commands the peritoneal dialysis device 1 to move the waste dialysis fluid from the patient P to the discharge unit 66.

[0342] Control unit 5 opens and holds discharge valve 39 and patient valve 54, and closes and holds heater valve 45, bypass valve 51, first dialysis valve 42, and second dialysis valve 43. Control unit 5 commands the motor to rotate in the second direction ( FIG. 11 The peristaltic pump 6 is rotated clockwise to pump dialysis fluid from the second compartment 23 to the first compartment 22.

[0343] The processing order is shown in the table below (Table 3).

[0344] Table 3

[0345]

[0346] Example 2

[0347] FIG. 16 and FIG. 17 Another embodiment of the manifold assembly 3 of the peritoneal dialysis device 1 (APD) is shown. The circulator 2 of this embodiment is not shown, but may have the same structure / architecture as the circulator disclosed in the first embodiment.

[0348] Manifold assembly 3 (organizes the piping and performs many of the functions discussed in this article) FIG. 16 and FIG. 17 It differs from manifold assembly 3 of Example 1 in the following features.

[0349] Compare FIG. 3 and FIG. 16 As can be seen (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 rather than inside the first compartment 22. The first dialysis valve 42 and the second dialysis valve 43 are located in the second compartment 23 and are close to the second expansion chamber 24b.

[0350] The first dialysis fluid tubing 59 has a first end connected to the first supply bag 60 and a second end connected to the second compartment 23. The second dialysis fluid tubing 61 has a first end connected to the second supply bag 62 and a second end connected to the second compartment 23.

[0351] Furthermore, the discharge port 36 and the discharge fluid line 65 are arranged near the top of the housing 19 and above the heater port 44 and the heater line 63 when the manifold assembly 3 is properly installed on the circulator 2.

[0352] The second inner diaphragm 28 has a first end that is connected to the right long side of the plastic rigid housing 20 (near the second pump port 35) and is different from... FIG. 3 In one embodiment, the area of ​​the second compartment 23 having the holes 31 and the breathable membrane 33 is not separated from the bypass valve 51 by the second inner diaphragm 28.

[0353] In addition, the hole 31 and the breathable membrane 33 are located near the top short side of the plastic rigid housing 20.

[0354] When the manifold assembly 3 is properly mounted on the circulator 2, area 67 of the plastic sheet 21 is configured to be connected to the displacement sensor 68 of the circulator 2 (shown schematically only).

[0355] FIG. 16 The area 67 is shown, which is the region located at the bottom right bend of the generally U-shaped first elongated channel of the first compartment 22. Displacement sensor 68 is mounted on the front panel 13 of the circulator 2.

[0356] The flow path from heating bag 64 to patient P and the flow path from patient P to the discharge section are related to... FIG. 10 and FIG. 11 The same as shown, and disclosed in the preceding paragraphs.

[0357] Due to the different positions of the first dialysis valve 42 and the second dialysis valve 43, the flow path from the first supply bag 60 to the heating bag 64 is different. FIG. 9 The path shown.

[0358] In fact, in this second embodiment ( FIG. 17 and FIG. 18 Control unit 5 opens and maintains the open heater valve 45 and the first dialysis valve 42, while closing and maintaining the closed bypass valve 51, the second dialysis valve 43, the drain valve 39, and the patient valve 54. Control unit 5 commands the motor to rotate in the second direction ( FIG. 9 The peristaltic pump 6 is rotated clockwise to pump dialysis fluid from the second compartment 23 to the first compartment 22.

[0359] The processing sequence of the manifold assembly 3 in the second embodiment is shown in the table below (Table 4).

[0360] Table 4

[0361]

[0362]

[0363] Prior to patient treatment, the manifold assembly 3 of the second embodiment is pre-charged. The following table (Table 5) lists the possible pre-charge sequences.

[0364] Table 5

[0365]

[0366] Example 3

[0367] FIG. 19 Another embodiment of the manifold assembly 3 of a peritoneal dialysis device 1 (APD) is shown. The circulator 2 in this embodiment differs from the first embodiment because the valve is not part of the housing 7, and the closure element of the circulator 2 is a pinch valve.

[0368] In this third embodiment, as in the second embodiment, by comparison FIG. 3 , FIG. 16 and FIG. 19 As can be seen (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 rather than inside the first compartment 22.

[0369] All ports do not include valves or parts thereof. Similar to the second embodiment, the discharge port 36 and the discharge fluid line 65 are arranged near the top of the housing 19.

[0370] The second inner diaphragm 28 separates the area of ​​the second compartment 23 with the perforated 31 and the breathable membrane from the area of ​​the second compartment 23 with the auxiliary discharge port 69 connected to the auxiliary discharge fluid line 70.

[0371] The discharge valve 39, the first dialysis valve 42, the second dialysis valve 43, the heater valve 45, and the patient valve 54 are clamping parts of the circulator 2 and operate on sections of the discharge fluid line 65, the first dialysis fluid line 59, the second dialysis fluid line 61, the heater line 63, and the patient line 58. The clamps and the sections together form a clamp valve.

[0372] Furthermore, the auxiliary discharge valve 71 acts on the auxiliary discharge fluid line 70, and the discharge fluid line 65 merges with the auxiliary discharge fluid line 70 in a shared discharge line before reaching the discharge section 66. FIG. 19 ).

[0373] The flow path from heating bag 64 to patient P and the flow path from patient P to the discharge section are related to... FIG. 10 and FIG. 11 The same as shown, and disclosed in the preceding paragraph (first embodiment).

[0374] The flow path from the first supply bag 60 to the heating bag 64 is the same as in the second embodiment (see Table 3).

[0375] The following table (Table 6) lists the possible precharge sequences.

[0376] Table 6

[0377]

[0378] valve

[0379] In some embodiments, the valve is part of the sleeve and is shaped like a... FIG. 20A , FIG. 20B , FIG. 20C As shown. For example, FIG. 16 and FIG. 17 All valves in Example 2 (discharge valve 39, first dialysis valve 42, second dialysis valve 43, heater valve 45, bypass valve 51, patient valve 54) are FIG. 20A The type shown.

[0380] This valve is configured to be compatible with FIG. 21A , FIG. 21B , FIG. 21C , FIG. 21D , FIG. 22 and FIG. 23 The blocking element 7 shown works together.

[0381] The blocking element 7 includes a plunger 15, similar to... FIG. 6A , FIG. 6B and FIG. 7 As shown in one of them, and also includes a mechanically tensioned plunger 76. (See example...) FIG. 22 and FIG. 23 As shown, both plunger 15 and tensioning plunger 76 are mechanically connected to actuator 73.

[0382] exist FIG. 22 In this embodiment, actuator 73 is a linear actuator connected to shaft 74. The distal end of shaft 74 carries plunger 15, and a damping and / or elastic element 75 (such as a spring) is positioned between the distal end and said plunger 15. The plunger 15 is shaped like a cup that houses a spring.

[0383] The damping and / or elastic element 75 allows for a reduction in the force applied to the membrane 21 to avoid damage to the membrane 21.

[0384] Similar to FIG. 16 andFIG. 17 As shown, actuator 73 is configured to move plunger 15 axially between a retracted position and an advanced position. In the retracted position, plunger 15 is spaced apart from diaphragm 21 and the port is open. In the advanced position, plunger 15 is at least partially housed in a seat, and diaphragm 21 is deformed and confined between plunger 15 and the seat to close the port.

[0385] The diaphragm tensioner 72 is configured to lift the diaphragm 21 away from the seat when the plunger 15 returns to the retracted position, and to counteract any possible negative pressure that might keep the valve closed.

[0386] The membrane tensioner 72 includes a tensioning plunger 76, which is also mechanically connected to the actuator 73. The tensioning plunger 76 is generally cylindrical in shape, coaxial with the plunger 15, and at least partially surrounds the plunger 15.

[0387] The tensioning plunger 76 includes 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. FIG. 24 and FIG. 25 ).

[0388] The tensioning plunger 76 is mounted on the shaft 74 and is axially movable along the shaft 74. The boundary of the arched wall 76a of the tensioning plunger 76 faces the soft membrane 21, and the plunger 15 can protrude from the tensioning plunger 76.

[0389] The actuator 73 is also configured to move the tension plunger 76 between a retracted position and an advanced position. In the retracted position, the tension plunger 76 is spaced apart from the diaphragm 21. In the advanced position, the tension plunger 76 engages the diaphragm 21 at a position other than the edge of the seat to remove the diaphragm 21 from the edge and stretch the diaphragm 21 over the seat.

[0390] In other embodiments not shown, the tensioning plunger 76 may be moved by an auxiliary actuator not shown.

[0391] The actuator 73 is housed in the housing 4 of the circulator 2; the plunger 15, the tensioning plunger 76 and the shaft 74 are guided through the opening formed in the housing 4 of the circulator 2.

[0392] When plunger 15 is in the forward position, tension plunger 76 is in the retracted position. FIG. 21A and FIG. 21B In this configuration, plunger 15 protrudes from tension plunger 76.

[0393] When plunger 15 is in the retracted position, tension plunger 76 is in the forward position. FIG. 21C and FIG. 21D In this configuration, the plunger 15 is completely contained within the tensioning plunger 76 and does not protrude beyond the boundary of the tensioning plunger 76.

[0394] The blocking element 7 includes a reversing mechanism that connects the tensioning plunger 76 and the plunger 15. The reversing mechanism is configured to move the plunger 15 in the opposite direction to the direction of movement of the tensioning plunger 76 when the plunger 15 is moved by the actuator 73.

[0395] exist FIG. 22 In one embodiment, the tensioning plunger 76 includes a protrusion 77 extending parallel to the shaft 74 and a rocker arm 78. A first end of the rocker arm 78 is hinged to the shaft 74 of the plunger 15, a second end of the rocker arm 78 is hinged to the protrusion 77 of the tensioning plunger 76, and a middle portion of the rocker arm 78 is hinged to a fixed portion of the circulator 2, for example, to a part of the housing 4.

[0396] When the linear actuator moves the plunger 15 to the forward position, the rocker arm 78 tilts and moves the tensioned plunger 76 to the retracted position. When the linear actuator moves the plunger 15 to the retracted position, the rocker arm 78 tilts and moves the tensioned plunger 76 to the forward position.

[0397] FIG. 22A A variant embodiment includes an additional damping and / or elastic element 75a (spring) coupled to the tensioning plunger 76. In this embodiment, the cylinder defining the tensioning plunger 76 is divided into two parts. The first part is rigidly connected to the protrusion 77. The second part carries the boundary of the arched wall 76a of the tensioning plunger 76 facing the membrane 21. The additional damping and / or elastic element 75a is located between the first and second parts.

[0398] The additional damping and / or elastic element 75a allows for a reduction in the force applied to the diaphragm 21 by the tensioning plunger 76 to avoid damage to the diaphragm 21. Another function of the additional damping and / or elastic element 75a is to compensate for possible plastic deformation of the diaphragm 21, which may result in loss of elasticity and plastic deformation over time. Even if the diaphragm 21 is plastically stretched, the additional damping and / or elastic element 75a is always able to push the edge of the arched wall 76a of the tensioning plunger 76 against the diaphragm 21 (advanced position) to remove the diaphragm 21 from the edge and stretch the diaphragm 21 above the seat.

[0399] exist FIG. 23 In one embodiment, the actuator 73 is a stepper motor, including a rotating shaft 79 connected to a shaft 74 of the plunger 15. The rotating shaft 79 has external threads and is connected to the internal threads of the shaft 74 via a left-hand threaded connector 80.

[0400] Shaft 74 has an external thread and is connected to the internal thread of tensioning plunger 76 via right-hand threaded connector 81.

[0401] The tensioning plunger 76 and shaft 74 are axially guided by the fixing element 82, for example, to a part of the housing 4.

[0402] The rotation of the rotatable shaft 79 caused by the stepper motor causes the shaft 74 to move axially only in a first direction (the shaft 74 does not rotate), for example, toward the forward position of the plunger 15.

[0403] The axial movement of the shaft 74 due to the left-hand threaded connector 80 drives the rotation of the tensioning plunger 76, and due to the different pitches of the left-hand threaded connector 80 and the right-hand threaded connector 81, it also drives the tensioning plunger 76 to move axially in a second direction opposite to the first direction (e.g., toward the retracted position of the tensioning plunger 76).

[0404] When the stepper motor moves the plunger 15 to the forward position, the left-hand threaded connector 80 and the right-hand threaded connector 81 move the tensioned plunger 76 to the retracted position. When the stepper motor moves the plunger 15 to the retracted position, the left-hand threaded connector 80 and the right-hand threaded connector 81 move the tensioned plunger 76 to the forward position.

[0405] In order to work properly with the plunger 15 and the diaphragm tensioner 72, the valve has a circular edge 83 defining the seat and an auxiliary edge 84 extending partially around the circular edge 83 and spaced apart from the edge 83.

[0406] replace FIG. 6A , FIG. 6B and FIG. 7 The hollow cylinder 38 in the valve includes a forming member 85 that protrudes from the bottom surface of the respective compartments 22, 23 and includes an edge 83 and an auxiliary edge 84.

[0407] The forming member 85 is approximately cylindrical and defines a central cylindrical cavity 86. An edge 83 defines the upper part of the cavity 86, and an auxiliary edge 84 includes two arcuate portions coaxial with the cavity and the edge 83.

[0408] like FIG. 20A to FIG. 21D As shown, the auxiliary edge 84 is raised relative to the edge 83, such that when the manifold assembly 3 is properly installed on the portion 14 of the circulator 2, the auxiliary edge 84 is closer to the blocking element than the edge 83.

[0409] FIG. 21A to FIG. 21D The operating steps of the assembly, including the valve and the shut-off element 7, are shown.

[0410] exist FIG. 21A In the middle position, the valve is closed. The plunger 15 is in the forward position and partially accommodated in the seat, with the diaphragm 21 constrained between the plunger 15 and the edge 83.

[0411] exist FIG. 21B Even if the plunger 15 is partially lifted, the valve remains closed because the negative pressure keeps the diaphragm 21 against the edge 83.

[0412] exist FIG. 21C In the middle, the valve is open because the tensioning plunger 76, in the forward position, partially surrounds the forming member 85 and the auxiliary edge 84, and resists the auxiliary edge 84 from pulling the diaphragm 21. Thus, the diaphragm 21 separates from the edge 83.

[0413] In this position, the forming member 85 is at least partially located within the tensioning plunger 76. For example... FIG. 25 As shown, each arched wall 76a of the tensioning plunger 76 is close to one of the two arched portions of the auxiliary edge 84 and is located radially outside the arched portion of the auxiliary edge 84.

[0414] Window 76b faces the radial opening defined between the arched walls 76a and allows fluid communication between the cylindrical cavity 86 and the first or second compartments 22, 23, thus the valve is open. FIG. 21D ).

[0415] The structure of the valve and occlusion element 7 that was just disclosed may also be part of other types of medical devices (such as dialysis devices for extracorporeal blood processing) and not necessarily part of the peritoneal dialysis device disclosed above.

[0416] Medical devices may include dialysis machines and manifold assemblies, and the manifold assembly may be mounted on or can be mounted on the dialysis machine.

[0417] The manifold assembly includes a housing comprising a rigid outer shell and at least one flexible diaphragm, the rigid outer shell and the flexible diaphragm defining at least a first fluid channel. The rigid outer shell includes at least one port in fluid communication with a first fluid channel and a second fluid channel. The at least one port has a seat and a flexible diaphragm facing the seat.

[0418] The dialysis machine includes at least one occlusion element 7, which faces the seat with the dialysis membrane 21 located therebetween when the manifold assembly is properly mounted on the dialysis device. The seat is configured to at least partially accommodate the corresponding occlusion element 7 of the dialysis machine.

[0419] A dialysis device can be a device for extracorporeal blood processing, comprising: a blood processing unit; an extracorporeal blood circuit connected to the blood processing unit; a blood pump, wherein a pump section of the extracorporeal blood circuit is configured to be connected to the blood pump; and a treatment fluid circuit operatively connected to the extracorporeal blood circuit and / or the blood processing unit. The treatment fluid circuit includes a dialysis line connected to a fluid chamber of the treatment unit and a fluid drain line connected to the fluid chamber. The treatment fluid circuit includes an infusion circuit comprising one or more infusion lines for replacement fluid. A manifold assembly may be part of the extracorporeal blood circuit or the treatment fluid circuit.

[0420] calibration

[0421] The aforementioned manifold assembly 3 can be used to calibrate the peristaltic pump 6, that is, to estimate the stroke liquid volume of the output pump pipe 55 connected to the peristaltic pump 6 in order to meet the volume accuracy measurement requirements.

[0422] The following description refers to FIG. 16 and FIG. 17 The manifold assembly 3 of the second embodiment. This embodiment also... FIG. 25 and FIG. 26 As shown in the diagram, the upper part of the second compartment 23 and the air buffer volume are in fluid communication with the auxiliary chamber 87 of the circulator 2 via orifice 31, breathable membrane 33, and air filter 88. Pressure transducer 10 is connected to the auxiliary chamber 87, and air valve 89 allows opening or closing the communication between the auxiliary chamber 87 and ambient air.

[0423] The peristaltic pump 6 includes or is coupled to an encoder, which is not shown in the accompanying drawings. The encoder is operatively connected to the control unit 5 and configured to detect the position and movement of the pressure roller 6a of the peristaltic pump 6.

[0424] The control unit 5 is operatively connected to the motor of the peristaltic pump 6, to the first level sensor 8, to the second level sensor 9, to the air valve 10, to the actuator of the blocking element 7, and to the pressure transducer 10, and is configured and / or programmed to calibrate the peristaltic pump 6 according to the methods detailed herein.

[0425] like FIG. 26 As shown, a first liquid level sensor 8 or a high liquid level sensor and a second liquid level sensor 9 or a low liquid level sensor define a high liquid level "C" and a low liquid level "A" in a second compartment 23.

[0426] A first volume "V1" is defined in the second compartment 23 below the low liquid level "A". The first volume "V1" is approximately 10 ml. A second volume "V2" is defined in the second compartment 23 between the low liquid level "A" and the high liquid level "C". The second volume "V2" is between two and four times the rated stroke liquid volume of the peristaltic pump 6. The rated stroke liquid volume of the peristaltic pump 6 can be 7 ml, and the second volume "V2" is approximately 21 ml. A third volume "V3" is defined in the second compartment 23 above the high liquid level "C". The third volume "V3" is approximately 15 ml. An auxiliary chamber 87 internally defines a fourth volume "V4" of approximately 26 ml. The sum of the second, third, and fourth volumes is approximately 62 ml.

[0427] The output pump tube 55, formed into a ring, includes a circular portion 55a and two straight portions 55b. The circular portion 55a and the two straight portions 55b form a single tube. The straight portions 55b are connected to a first pump port 34 and a second pump port 35, respectively. The circular portion 55a is configured to be pressed and deformed / squeezed by the pressure roller 6a of the peristaltic pump 6.

[0428] SeeFIG. 25 If the peristaltic pump 6 rotates counterclockwise, each of the two pressure rollers 6a begins to squeeze the round portion 55a located at the bottom between the lower portions of the round portion 55a and the two straight portions 55b, and releases the round portion 55a located at the top between the upper portions of the round portion 55a and the two straight portions 55b.

[0429] To calibrate the peristaltic pump 6, i.e., to estimate the stroke volume of the liquid in the pump tube 55, the following procedure is performed (refer to...). FIG. 25 to FIG. 28 ).

[0430] The drain valve 39, first dialysis valve 42, second dialysis valve 43, bypass valve 51, and patient valve 54 are closed. The heater valve 45 is opened, and the heating bag 64 is filled with water. The air valve 89 is opened.

[0431] Control unit 5 controls peristaltic pump 6 to start rotating counterclockwise, pumping water from heating bag 64 into first compartment 22, and then into second compartment 23. When low level sensor 9 detects water ( FIG. 27 A in II Peristaltic pump 6 stops.

[0432] The peristaltic pump 6 then rotates clockwise to lower the water level until the low level sensor 9 no longer detects water, and then stops again. FIG. 27 A in I ).

[0433] Peristaltic pump 6 rotates counterclockwise again. When low level sensor 9 detects water again... FIG. 26 and FIG. 27 When the liquid level is low (A), the control unit 5 controls the peristaltic pump 6 to rotate counterclockwise and pump water from the second compartment 23. Simultaneously, starting from the detection of water by the low liquid level sensor 9, the control unit 5 begins counting encoder pulses.

[0434] When the predetermined number of pulses "Delta_Encoder_Pulses" (e.g., 280 pulses) corresponding to the predetermined rotation angle "Delta" (e.g., 105°) of the peristaltic pump 6 is reached, and the water level is at the first liquid level B ( FIG. 26 and FIG. 27 When the air valve 89 closes, the peristaltic pump 6 continues to rotate counterclockwise to pump more water into the second compartment 23 and compress the air in the volume above the water level.

[0435] One of the two pressure rollers 6a is positioned at the end of a predetermined rotation angle "Delta". This predetermined position can be located on the portion between the circular portion 55a and one of the two straight portions 55b of the output pump pipe 55. When the pressure roller 6a is in the predetermined position, the water level is the first liquid level B. An additional volume of water, "Extra_Volume", is pumped to raise the liquid level from the low liquid level A to the first liquid level B. FIG. 26 and FIG. 27 ).

[0436] Starting from the predetermined position of the peristaltic pump 6 and from the first liquid level B, the control unit 5 causes the peristaltic pump 6 to rotate counterclockwise a predetermined number of revolutions "Rotor_rev", which is defined by "n" half-revolutions of the peristaltic pump 6, where "n" is an integer (e.g., n = 7). The rotational speed of the peristaltic pump 6 can be 5 rpm.

[0437] Thus, at the end of “n” half-turns, the same pressure roller 6a is repositioned in the predetermined position, and the water level rises to the second liquid level D.

[0438] Because the pressure roller 6a passes through the predetermined position several times during "n" half-turns, the water level is sensed by the high liquid level sensor 8, and the peristaltic pump 6 stops rotating when the pressure roller 6a first reaches the predetermined position after detecting the high liquid level C. FIG. 26 and FIG. 27 ).

[0439] The air pressure in the second compartment 23 is measured by the pressure transducer 10. The initial pressure P before air compression is taken. Init (First liquid level B) and the final pressure P after air compression Final (Second liquid level D). Initial pressure P Init The pressure difference is approximately 0 mmHg (relative to atmospheric pressure), and the final pressure is approximately 400 mmHg.

[0440] After stopping the rotation of peristaltic pump 6 and obtaining the final pressure P Final Previously, it was necessary to wait for a period of time to stabilize and continue measuring the pressure. FIG. 27 D in I ), to check for possible leaks.

[0441] As the peristaltic pump 6 rotates at a predetermined number of revolutions "Rotor_rev", the change in the liquid volume "Vol_Moved" in the second compartment 23 subsequently serves as the initial air volume "Compensated_Volume" above the first liquid level B and the initial pressure P. Init and final pressure P Final The function is used to calculate.

[0442] 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 water volume between the first liquid level B and the low liquid level A, i.e. the water volume moved by the rotation “Delta” of the peristaltic pump 6.

[0443] 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-turns of the peristaltic pump 6. The calculation of the disclosed stroke fluid volume "Stroke_Vol_Press" can be performed continuously two to five times to determine the average stroke fluid volume.

[0444] This calibration method can also be implemented in other medical devices, including medical machines equipped with peristaltic pumps and including manifold assemblies, such as in devices of the type disclosed above for extracorporeal blood processing.

[0445] The process detailed above can be summarized by the following formula.

[0446] a.Vol_Extra=2*(Delta_Encoder_Pulses / m)*Stroke_Vol_Press

[0447] b.Compensated_Volume=((V2+V3+V4)-Vol_Extra)

[0448] c.Vol_Moved=Compensated_Volume*((Pressure_Final-Pressure_Init) / Pressure_Final)

[0449] d.Rotor_rev=(Zc-Yc) / m

[0450] e.Stroke_Vol_Press=2*(Vol_Moved / Rotor_rev

[0451] f.Stroke_Vol_Press=2*(m / (Zc-Yc))*((V2+V3+V4)-(Delta_Encoder_Pulses / 2m*Stroke_Vol_Press))*((Pressure_Final-Pressure_Init) / Pressure_Final))

[0452] Stroke_Vol_Press can be calculated by equation f, where:

[0453]

[0454]

Claims

1. A manifold assembly for a peritoneal dialysis device, comprising: The housing (19) internally defines a first compartment (22) and a second compartment (23); The output pump tube (55) has a first end (56) connected to the first compartment (22) and a second end (57) connected to the second compartment (23), wherein the output pump tube (55) extends outside the housing (19) to be coupled to the peristaltic pump (6) of the circulator (2) of the peritoneal dialysis device (1); wherein the housing (19) includes a first pump port (34) connected to the first end of the output pump tube (55) and a second pump port (35) connected to the second end of the output pump tube (55); Multiple tubing (58, 59, 61, 63, 65), each tubing having a first end connected to the first compartment (22) or the second compartment (23) and a second end capable of connecting to a fluid source (60, 62, 64) or a discharge unit (66) or a patient (P); wherein the housing (19) includes multiple ports (53, 36, 40, 41, 44), each port connected to the first end of a tubing (58, 59, 61, 63, 65); The housing (19) has a generally flat shape and is provided with a front, a back and multiple sides; wherein the back is configured to be connected to the front panel (13) of the circulator (2); The first pump port (34) and the second pump port (35) are located on the first side of the housing (19); and the ports (53, 36, 40, 41, 44) are located on the second side of the housing (19) opposite to the first side.

2. The component 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 a corresponding side of the housing (19).

3. The component 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) is shaped like a hollow cylinder.

4. The component according to claim 3, wherein, The hollow cylinders of the multiple ports (53, 36, 40, 41, 44) are parallel to each other.

5. The component according to claim 3, wherein, The hollow cylinders of the first pump port (34) and the second pump port (35) are separated from each other away from the housing (19), such that the output pump tube (55) is formed into an "Ω" shaped ring.

6. The component according to any one of claims 1 to 5, wherein, The housing (19) has a generally rectangular outline with two long sides and two short sides; wherein the first side and the second side are both long sides of the housing (19).

7. The component according to any one of claims 1 to 5, wherein, The housing (19) includes a rigid outer shell (20) defining the front and multiple sides of the housing (19), and a soft membrane (21) defining the back of the housing (19).

8. The component according to any one of claims 1 to 5, wherein, The housing (19) has through holes (29a, 29b) passing through the housing (19); wherein the through holes (29a, 29b) are configured to engage with the retaining element of the circulator (2).

9. The component according to any one of claims 1 to 5, wherein, The housing (19) includes at least one protrusion (25a, 25b, 25c) that defines at least one expansion chamber (24a, 24b, 24c) in the second compartment (23) such that the depth of the at least one expansion chamber (24a, 24b, 24c) is greater than the depth of the remainder of the second compartment (23); wherein the protrusion (25a, 25b, 25c) protrudes from the front of the housing (19).

10. The component of claim 9, wherein, The housing (19) includes through holes (29a, 29b) and a plurality of protrusions (25a, 25b, 25c) passing through the housing (19), wherein the through holes (29a, 29b) are between two of the protrusions (25a, 25b, 25c).

11. The component according to any one of claims 1 to 5, wherein, The housing (19) includes a breathable membrane (33) connected to the edge of a hole (31) in the housing (19) and configured to cause the pressure transducer (10) and / or air pump (11) of the circulator (2) to communicate with the upper part of the second compartment (23) when the manifold assembly (3) is properly mounted on the circulator (2).

12. The component of claim 11, wherein, A hole (31) is formed in the front of the housing (19); wherein a rigid frame (32) supports the breathable membrane (33).

13. The component according to any one of claims 1 to 5, wherein, The first compartment (22) is a U-shaped elongated channel, and the second compartment (23) is partially surrounded by the U-shaped elongated channel.

14. The component according to any one of claims 1 to 5, wherein, The plurality of conduits (58, 59, 61, 63, 65) include: A patient tube (58) having a first end connected to the second compartment (23) and a second end capable of connecting to the peritoneal cavity of the patient (P); wherein, the patient port (53) of the plurality of ports (53, 36, 40, 41, 44) is connected to the first end of the patient tube (58); At least one fluid conduit (59, 61, 63, 65; 63, 65) has a first end connected to the first compartment (22) and a second end capable of being connected to the fluid source (60, 62, 64; 64) or the discharge section (66); wherein at least one fluid conduit (59, 61) has a first end connected to or capable of being connected to the second compartment (23) and a second end capable of being connected to the fluid source (60, 62); wherein a fluid port (36, 40, 41, 44) of a plurality of ports (53, 36, 40, 41, 44) is connected to one of the first ends of the fluid conduit (59, 61, 63, 65).

15. The component according to any one of claims 1 to 5, wherein, The housing (19) includes a bypass passage (49) in fluid communication with the first compartment (22) and the second compartment (23) and the heater line (63); wherein the bypass passage (49) is at least partially defined by a cover (50) attached to the outer surface of the housing (19).

16. A manifold assembly for a peritoneal dialysis device, comprising: The housing (19) internally defines a first compartment (22) and a second compartment (23); The output pump tube (55) has a first end (56) connected to the first compartment (22) and a second end (57) connected to the second compartment (23), wherein the output pump tube (55) extends to the outside of the housing (19) to be connected to the peristaltic pump (6) of the circulator (2) of the peritoneal dialysis device (1); The patient catheter (58) has a first end connected to the second compartment (23) and a second end capable of connecting to the peritoneal cavity of the patient (P); At least one fluid conduit (59, 61, 63, 65; 63, 65) has a first end connected to the first compartment (22) and a second end capable of being connected to a fluid source (60, 62, 64; 64) or a discharge section (66); At least one fluid conduit (59, 61) has a first end that is connected to or can be connected to the second compartment (23) and a second end that can be connected to the fluid source (60, 62); The first compartment (22), the output pump tube (55), and the second compartment (23) together define a fluid path from the at least one fluid line (59, 61, 63, 65; 63, 65) connected to the first compartment (22) at its first end, through the output pump tube, to the patient line (58), so that when the peristaltic pump (6) of the circulator (2) is activated, fluid is allowed to flow from at least the at least one fluid line (59, 61, 63, 65; 63, 65) connected to the first compartment (22) at its first end through the output pump tube to the patient line (58), or from the patient line (58) through the output pump tube to the at least one fluid line (59, 61, 63, 65; 63, 65) connected to the first compartment (22) at its first end; The second compartment (23) defines at least one expansion chamber (24a, 24b, 24c), which is configured to reduce pressure pulsations from the peristaltic pump (6).

17. The component of claim 16, wherein, The at least one expansion chamber (24a, 24b, 24c) is partially defined by a soft membrane (21); wherein the at least one soft membrane (21) is made of a plastic sheet.

18. The component of claim 16, wherein, The internal volume of the second compartment (23), which includes at least one expansion chamber (24a, 24b, 24c), is greater than the internal volume of the first compartment (22).

19. The component of claim 16, wherein, The housing (19) includes a breathable membrane (33) configured to cause the pressure transducer (10) and / or air pump (11) of the circulator (2) to communicate with the upper part of the second compartment (23).

20. The component of claim 16, wherein, The at least one fluid conduit (59, 61, 63, 65; 63, 65) connected at one end to the first compartment (22) includes a heater conduit (63), a heating bag (64) connected to the second end of the heater conduit (63), and a discharge fluid conduit (65) whose second end can be connected to the discharge section (66).

21. The component of claim 20, wherein, The at least one fluid line (59, 61, 63, 65) connected at its first end to the first compartment (22) includes a plurality of dialysis fluid lines (59, 61) and a supply bag (60, 62) connected to the second end of the dialysis fluid line (59, 61).

22. The component of claim 16, wherein, The at least one fluid line (59, 61) connected at its first end to the second compartment (23) includes one or more dialysis fluid lines (59, 61) and at least one supply bag (60, 62) connected to the second end of the one or more dialysis fluid lines (59, 61).

23. The component of claim 16, wherein, The housing (19) includes: a first pump port (34) connected to a first end (56) of the output pump tube (55) and in fluid communication with the first compartment (22); a second pump port (35) connected to a second end (57) of the output pump tube (55) and in fluid communication with the second compartment (23); a patient port (53) connected to a first end of the patient tubing (58) and in fluid communication with the second compartment (23); at least one fluid port (40, 41, 44, 36; 36, 44) connected to a first end of the at least one fluid tubing (59, 61, 63, 65; 63, 65) connected to and in fluid communication with the first compartment (22); and at least one fluid port (40, 41) connected to a first end of the at least one fluid tubing (63, 65) connected to and in fluid communication with the second compartment (23).

24. The component of claim 23, wherein, The at least one fluid port (40, 41, 44, 36) includes a corresponding valve (42, 43, 45, 39) or a portion thereof; wherein the at least one fluid port (40, 41, 44, 36) has a seat for at least partially receiving a corresponding occlusion element (7) of the circulator (2); wherein the patient port (53) includes a corresponding valve (54) or a portion thereof; wherein the at least one patient port (53) has a seat for at least partially receiving a corresponding occlusion element (7) of the circulator (2).

25. The component of claim 20, wherein, The housing (19) includes a bypass channel (49) in fluid communication with the first compartment (22), the second compartment (23) and the heater conduit (63).

26. The component of claim 25, wherein, The first compartment (22) includes a bypass port (52) in fluid communication with the bypass passage (49); wherein the bypass port (52) includes a corresponding valve (51) or part of a valve; wherein the bypass port (52) has a seat for at least partially accommodating a corresponding closure element (7) of the circulator (2).

27. The component according to any one of claims 16 to 26, wherein, The first compartment (22) is a first elongated channel extending between one of the at least one fluid line (59, 61, 63, 65; 63, 65) and a first end (56) of the output pump tube (55), wherein the first elongated channel is generally U-shaped.

28. The component of claim 27, wherein, The first end of the heater line (63), the first end of the discharge fluid line (65), and the first ends of the plurality of dialysis fluid lines (59, 61) are arranged one after the other along the longest section of the U-shaped elongated channel, and the first end (56) of the production pump line (55) is connected to the end of the U-shaped elongated channel.

29. The component of claim 27, wherein, The second compartment (23) includes a diaphragm that defines a second elongated channel in fluid communication with the at least one expansion chamber (24a, 24b, 24c); wherein the second elongated channel has a first end connected to a second end (57) of the output pump tube (55) and a second end in communication with the at least one expansion chamber (24a, 24b, 24c).

30. The component according to any one of claims 16 to 26, wherein, The housing (19) has a flat shape and includes at least one protrusion (25a, 25b, 25c) that defines at least one expansion chamber (24a, 24b, 24c) such that the depth of the at least one expansion chamber (24a, 24b, 24c) is greater than the depth of the remainder of the second compartment (23).

31. The component according to any one of claims 16 to 26, wherein, The housing (19) has an external flat surface for docking with at least one level sensor (8, 9) of the circulator (2) and through-holes (29a, 29b) of a flat shape; wherein a plurality of expansion chambers (24a, 24b, 24c) are defined in the second compartment (23), and in fact the through-holes (29a, 29b) are located between two of the plurality of expansion chambers (24a, 24b, 24c).

32. The component according to any one of claims 16 to 26, wherein, The housing (19) includes a rigid outer shell (20) and at least one soft membrane (21) made of a plastic sheet, the at least one soft membrane (21) being welded or bonded to the rigid outer shell (20); wherein the rigid outer shell (20) defines the front and sides of the housing (19), and the at least one soft membrane (21) is the back of the housing (19).

33. The component of claim 32, wherein, The at least one diaphragm (21) faces a seat for at least partially accommodating a corresponding occlusion element (7) of the circulator (2); wherein the diaphragm (21) is configured to deform by the occlusion element (7) to close the patient port (53) or fluid port (40, 41, 44, 36) when the occlusion element (7) is accommodated in the seat.

34. The component of claim 32, wherein, The region (67) of the at least one diaphragm (21) is configured to be coupled to the displacement sensor (68) of the circulator (2) when the component (3) is properly mounted on the circulator (2), the region (67) facing the region of the first compartment (22).

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