Thermal sterilization system for medical device

Abstract

A thermal disinfection system and method for performing a thermal disinfection process of a fluid line of a medical device wherein the thermal disinfection process comprises at least the steps of receiving a temperature signal from a temperature sensor, determining a measured temperature value Tfluidmes of a fluid within a hydraulic circuit, receiving a pressure signal from a pressure sensor, determining a measured local atmospheric pressure value Patm, and determining a measured local atmospheric pressure value Patm. And driving a heating unit to heat the fluid based on the measured temperature value Tfluidmes and the measured local atmospheric pressure value Patm.

Description

[0001] This application is a divisional application of a patent application with an application date of July 6, 2021, application number 2021800620680, and invention name “Thermal disinfection system for medical equipment”. Technical Field

[0002] The invention relates to a disinfection system capable of performing a thermal disinfection process in a medical device such as a blood treatment device or in a water purification device connectable to the medical device. In addition, the invention also relates to a disinfection system capable of performing a thermal disinfection process in a peritoneal dialysis device.

[0003] The invention further relates to a method for performing a thermal disinfection process in a medical device. Background Art

[0004] There are several types of treatments that extract blood in an extracorporeal blood circuit. For example, these treatments involve hemodialysis, hemofiltration, hemodiafiltration, plasma exchange, blood component separation, blood oxygenation, etc. Typically, blood is removed from a blood vessel at the access site and returned to the same blood vessel or to another location in the body.

[0005] Treatment fluid (also referred to as dialysis fluid) and patient's blood are made to flow on each side of the semipermeable membrane of membrane device (commonly referred to as dialyzer).When the substance concentration on each side of membrane is different, diffusion transfer from one side of membrane to the other side is realized.These substances can be impurities (urea, creatinine, etc.) in blood, thereby migrating from blood to treatment fluid.In the treatment by hemodiafiltration, the convection transfer of ultrafiltration caused by the pressure difference generated between the blood side of membrane and the treatment fluid side is added to the diffusion transfer.

[0006] An apparatus for extracorporeal blood treatment may include a dialysis machine connected to a disposable extracorporeal blood circuit. The disposable extracorporeal blood circuit includes blood transport lines (usually an arterial line for removing blood from a patient and a venous line for returning blood to the patient) and a membrane device for blood treatment.

[0007] The semipermeable membrane of the membrane device separates the blood compartment connected to the blood delivery line from the fluid compartment connected to the treatment fluid supply and discharge circuit. The blood delivery line can be further connected to a sensor and actuator system equipped on the dialysis machine, which generally includes a device for blood circulation, a pressure sensor, a bubble sensor, one or more circuit blocking clamps, a blood detector, etc.

[0008] The treatment fluid supply loop receives purified water from a water supply system. The water supply system can be a small unit that provides water to only a single treatment control machine, but can also be a large unit that provides water to a large number of treatment units, for example in a hospital or clinic, by means of a water system loop arrangement.

[0009] The dialysis fluid that may come into contact with the patient's blood is usually prepared from purified water via a treatment fluid supply circuit. It is very important that the dialysis fluid used for treatment is substantially free of viruses, fungi, bacteria and their residues and degradation products, such as endotoxins.

[0010] Therefore, the treatment fluid path of the dialysis machine can be disinfected between dialysis treatments in order to reduce the presence of viruses, fungi, bacteria, etc. in the treatment fluid path. Chemical disinfection (e.g. using NaOCl or other chemical disinfectants) is an effective way to reduce the presence of bacteria, etc., but it places great demands on the subsequent flushing process and, for safety reasons, requires very close measurements to ensure that the treatment fluid path is free of chemical residual products before being used for subsequent treatments. Chemical processes are also not environmentally friendly and may have a negative impact on the life of the disinfected parts and components.

[0011] In an alternative sterilization method, thermal sterilization is achieved by introducing hot water into the treatment fluid path. Therefore, there is no problem of chemical residual products, the method has a smaller burden on the environment, and generally has a relatively small negative impact on the life of sterilized parts and components compared to the use of bio-aggressive solutions (such as chlorine).

[0012] In another alternative disinfection method, thermal disinfection is combined with a chemical agent such as citric acid to achieve effective disinfection of the treatment fluid path. WO96 / 09080 discloses a disinfection device for a dialysis machine, which includes a clean side and a dirty side. The clean side includes an inlet for water, a heat exchanger, and a water container containing a heater. The supply conduit leads from the water container to a tube, which is usually connected to the clean side of the dialyzer, but during disinfection, is connected to a recirculation conduit via a valve to perform a first recirculation loop. The second recirculation loop consists of a recirculation conduit, a valve, a tube usually connected to the dirty side of the dialyzer, a return conduit, and a pump. The heat exchanger heats the fluid in the second loop by means of the fluid in the first loop, and the fluid in the first loop is heated by the heater in the water container. A small amount of fluid is transferred from the first loop to the second loop via a shunt conduit.

[0013] Thermal disinfection of the treatment fluid path of the machine is preferably performed after each patient's treatment. With the increase in the number of dialysis patients, there is a need to increase the available time for clinical treatment. Therefore, it is desirable to reduce the time spent on disinfection between treatments.

[0014] An increase in the temperature of the fluid will result in a decrease in the time required to perform the sterilization process: in any case, a temperature that is too high may cause the fluid to boil, which leads to the growth of bubbles within the circuit, thereby reducing the effectiveness of the sterilization process and certainly causing damage to the fluid lines. On the other hand, if the temperature of the fluid is reduced to prevent boiling, the time required for the sterilization of the circuit will increase accordingly.

[0015] CN106110350A discloses a hemodialysis machine with a sterilization unit. The boiling point T1 of the disinfectant solution depends on the ambient pressure, and boiling fluid may prevent effective sterilization from occurring. The sterilization solution proposed according to CN106110350A includes two similar embodiments. In the first case, the disinfection device calculates the boiling point T1 of the disinfectant solution based on the measured atmospheric pressure value; the disinfection device sets the temperature of the disinfectant solution at T2, slightly lower than the boiling point T1; the pipeline end temperature T3 is measured, and the device determines the concentration N1 of the disinfectant based on N1=k*(T3-80°C)*N, where N is the initial concentration of the disinfectant solution and k is a concentration adjustment coefficient between 0.50 and 2.00. The device determines the disinfection time M based on the concentration N1 of the liquid: M=pT3+qN1, where "p" is the temperature coefficient and "q" is the concentration factor.

[0016] WO 2014 / 082855 A1 relates to hot water disinfection of water systems and dialysis machines using the A0 disinfection concept. The application describes the use of disinfection algorithm A0 (according to standard ISO 15883-1:2009) for a washer disinfector in a water system / dialysis machine during the disinfection process.

[0017] WO2018 / 228765 relates to a water purification device capable of cleaning at the point of care. The water purification device provides for the efficient use of a heater for thermal disinfection, for example by recirculating heated fluid to further heat the fluid. Several different cleaning programs are provided, which can be used to clean different parts of the water purification device. To achieve this, the water purification device runs a thermal disinfection program to prevent the growth of bacteria in the fluid path. Thermal disinfection is based on the A0 concept that defines a thermal disinfection dose.

[0018] Purpose of the invention

[0019] Accordingly, the scope of the present invention is to at least partially address one or more disadvantages and / or limitations of previous solutions.

[0020] A first scope is to provide a thermal disinfection system capable of minimizing the time required for disinfection of medical devices.

[0021] Another scope is to provide a thermal disinfection system that is able to maximize the disinfection effect while reducing the time required for the disinfection process.

[0022] Another scope is to provide a thermal disinfection system capable of minimizing the time required for disinfection while avoiding damage to the hydraulic circuit of the medical device.

[0023] Another scope is to provide a thermal disinfection system which is a water purification device connectable to a medical device.

[0024] Summary of the invention

[0025] An aspect of the invention relates to a thermal disinfection system (1), comprising a control unit (500) configured to perform a thermal disinfection process of a hydraulic circuit (100) of a medical device, in particular a blood treatment device or a peritoneal dialysis device or a water purification device, the hydraulic circuit (100) of the medical device comprising at least one temperature sensor (127, 127', 128; 303, 313, 323), at least one pressure sensor (162; 362) and at least one heating unit (104, 302),

[0026] The thermal disinfection process comprises at least the following steps performed by the control unit (500):

[0027] - receiving a temperature signal from at least one temperature sensor (127, 127', 128; 303, 313, 323) and determining a measured temperature value T of the fluid within the hydraulic circuit (100) fluid_mes ;

[0028] - receiving a pressure signal from at least one pressure sensor (162; 362) and determining a measured

[0029] Local atmospheric pressure value P atm ;

[0030] - driving at least one heating unit (104; 302) to heat the room temperature based on the measured temperature value T fluid_mes and the measured local atmospheric pressure value P atm to heat the fluid.

[0031] Another independent aspect of the invention relates to a thermal disinfection system (1), comprising a control unit (500) configured to perform a thermal disinfection process of a hydraulic circuit (100) of a medical device, in particular a blood treatment device or a peritoneal dialysis device or a water purification device, the hydraulic circuit (100) of the medical device comprising at least one temperature sensor (127, 127', 128; 303, 313, 323), at least one pressure sensor (162; 362) and at least one heating unit (104, 302),

[0032] The thermal disinfection process comprises at least the following steps performed by the control unit (500):

[0033] - receiving a temperature signal from at least one temperature sensor (127, 127', 128; 303, 313, 323) and determining a measured temperature value T of the fluid within the hydraulic circuit (100) fluid_mes ;

[0034] - receiving a pressure signal from at least one pressure sensor (162; 362) and determining a measured

[0035] Local atmospheric pressure value P atm ;

[0036] - Based on a measured local atmospheric pressure value P of the fluid within the hydraulic circuit (100) atm and the measured temperature value T fluid_mes Either or both of the above, determining the disinfection process to be applied from multiple (at least two) available disinfection processes.

[0037] In another aspect according to the preceding aspect, determining a disinfection process to be applied comprises:

[0038] - Based on a measured local atmospheric pressure value P of the fluid within the hydraulic circuit (100) atm and the measured temperature value T fluid_mes Either or both of these determine the estimated time to complete the thermal disinfection process.

[0039] Time (T est );

[0040] - Estimated time to complete the thermal disinfection process (T est ) and reference time (T ref ) for comparison;

[0042] - Based on the comparison results, continue the thermal disinfection process or recommend / start a different disinfection process, e.g.

[0043] Chemical disinfection process.

[0044] In another aspect according to the preceding aspect, the different sterilization process requires less sterilization time than a thermal sterilization process.

[0045] A first aspect relates to a thermal disinfection system (1), comprising a blood treatment apparatus (10), the blood treatment apparatus comprising a hydraulic circuit (100) for fluid transport, the hydraulic circuit (100) having:

[0046] - at least one dialysis supply line (107) extending from the fluid inlet (101) to the dialysis

[0047] a dialysis fluid supply outlet (130) connected to the inlet of the device (150);

[0048] - a dialysis waste line (108) extending from a dialysate fluid return inlet (133) to a drain outlet (129), the dialysate fluid return inlet (133) being configured to be connected to an outlet of the dialyzer (150);

[0049] - a heating unit (104) configured to heat the fluid in the hydraulic circuit (100), in particular

[0050] water or disinfectant solution or dialysis fluid or mixtures thereof;

[0051] - at least one temperature sensor (127, 127', 128) configured to provide a temperature representative of the hydraulic return

[0052] A signal of the temperature of the fluid in the circuit (100);

[0053] - at least one pressure sensor (162) configured to provide a signal representative of the local atmospheric pressure;

[0054] The blood treatment device (10) comprises a control unit (500) configured to perform a thermal disinfection process of the hydraulic circuit (100), the thermal disinfection process comprising at least the following steps performed by the control unit (500):

[0055] - receiving a temperature signal from at least one temperature sensor (127, 127', 128) and determining

[0056] The measured temperature value T of the fluid in the hydraulic circuit (100) fluid_mes ;

[0057] - receiving a pressure signal from at least one pressure sensor (162) and determining a local pressure of the measurement

[0058] Atmospheric pressure value P atm ;

[0059] - Based on the measured temperature value T fluid_mes and the measured local atmospheric pressure value P atm To drive the heating unit (104) to heat the fluid.

[0060] A second aspect relates to a thermal disinfection system (1), comprising a water purification device (300), the water purification device comprising a hydraulic circuit connectable to a disposable device (40) of a peritoneal dialysis device, the hydraulic circuit comprising:

[0061] - an inlet port (399) for receiving water from a water source (398);

[0062] - a filtration unit comprising one or more water filters (160, 170, 180) configured to remove impurities from the water at least during a treatment procedure performed by the peritoneal dialysis device;

[0063] - a heating unit (302) configured to heat the fluid in the hydraulic circuit (100);

[0064] - at least one temperature sensor (303, 313, 323) configured to provide a temperature representative of the fluid

[0065] The signal of degree;

[0066] - at least one pressure sensor (362) configured to provide a signal representative of local atmospheric pressure;

[0067] The water purification device (300) comprises a control unit (500) configured to execute a thermal disinfection process of a hydraulic circuit of the water purification device (300), the thermal disinfection process comprising at least

[0068] The control unit (500) performs the following steps:

[0069] - receiving a temperature signal from at least one temperature sensor (303, 313, 323) and determining the liquid

[0070] The measured temperature of the water in the pressure circuit is T fluid_mes ;

[0071] - receiving a pressure signal from at least one pressure sensor (362) and determining a measured local

[0072] Atmospheric pressure value P atm ;

[0073] - Based on the measured temperature value T fluid_mes and the measured local atmospheric pressure value P atm To drive the heating unit (302) to heat the fluid.

[0074] A third aspect relates to a thermal disinfection system (1), comprising a peritoneal dialysis device, the peritoneal dialysis device comprising a hydraulic circuit (100) for fluid transmission, the hydraulic circuit (100) having:

[0075] - at least one dialysis fluid supply line, extending from a dialysis fluid inlet to a dialysis fluid supply outlet, configured to directly or indirectly transfer fresh peritoneal dialysis fluid to a catheter of the patient;

[0076] - Optionally, a dialysis waste line extending from a spent peritoneal dialysis fluid inlet to a drain outlet, the spent peritoneal dialysis fluid inlet (133) being configured to receive spent peritoneal dialysis fluid directly or indirectly from a catheter of a patient;

[0077] - a heating unit configured to heat the fluid in the hydraulic circuit (100);

[0078] - at least one temperature sensor configured to provide a temperature representative of the fluid in the hydraulic circuit (100)

[0079] Temperature signal;

[0080] - at least one pressure sensor (162) configured to provide a signal representative of the local atmospheric pressure;

[0081] The peritoneal dialysis treatment device comprises a control unit (500) configured to perform a thermal disinfection process of the hydraulic circuit (100), the thermal disinfection process comprising at least the following steps performed by the control unit (500):

[0082] - receiving a temperature signal from at least one temperature sensor and determining a temperature within the hydraulic circuit (100)

[0083] The measured temperature value T of the fluid fluid_mes ;

[0084] - receiving a pressure signal from at least one pressure sensor (162) and determining a local pressure of the measurement

[0085] Atmospheric pressure value P atm ;

[0086] - Based on the measured temperature value T fluid_mes and the measured local atmospheric pressure value P atm To drive the heating unit (104) to heat the fluid.

[0087] A fourth aspect relates to a method for thermal disinfection of a medical device, in particular for a blood treatment device (10) or a peritoneal dialysis device or a water purification device (300) connectable to a peritoneal dialysis device, optionally according to any of the preceding aspects, the medical device comprising a hydraulic circuit (100),

[0088] The method comprises a thermal disinfection process of the hydraulic circuit (100), the thermal disinfection process at least comprising:

[0089] The following steps are included:

[0090] - receiving a temperature signal from at least one temperature sensor (127, 127', 128; 303, 313, 323) and determining a measured temperature value T of the fluid within the hydraulic circuit (100) fluid_mes ;

[0091] - receiving a pressure signal from at least one pressure sensor (162) and determining a local pressure of the measurement

[0092] Atmospheric pressure value P atm ;

[0093] - Based on the measured temperature value T fluid_mes and the measured local atmospheric pressure value P atm To drive the heating unit (104; 302) to heat the fluid.

[0094] A fifth aspect relates to a method for thermal disinfection of a blood treatment device (10), the blood treatment device comprising a hydraulic circuit (100) for fluid transport, the hydraulic circuit (100) having:

[0095] - at least one dialysis supply line (107) extending from the fluid inlet (101) to a dialysis fluid supply outlet (130) connectable to an inlet of a dialyzer (150);

[0096] - a dialysis waste line (108) extending from a dialysate fluid return inlet (133) to a drain outlet (129), the dialysate fluid return inlet (133) being configured to be connected to an outlet of the dialyzer (150);

[0097] a heating unit (104) configured to heat a fluid within the hydraulic circuit (100), in particular water or a disinfectant solution or a dialysis fluid or a mixture thereof;

[0098] - at least one temperature sensor (127, 127', 128) configured to provide a signal representative of the temperature of the fluid in the hydraulic circuit (100);

[0099] - at least one pressure sensor (162) configured to provide a signal representative of the local atmospheric pressure;

[0100] The method comprises a thermal disinfection process of the hydraulic circuit (100), the thermal disinfection process comprising at least the following steps:

[0101] - receiving a temperature signal from at least one temperature sensor (127, 127', 128) and determining a measured temperature value T of the fluid within the hydraulic circuit (100) fluid_mes ;

[0102] - receiving a pressure signal from at least one pressure sensor (162) and determining a measured local atmospheric pressure value P atm ;

[0103] - Based on the measured temperature value T fluid_mes and the measured local atmospheric pressure value P atm To drive the heating unit (104) to heat the fluid.

[0104] In another independent aspect, a thermal disinfection system (1) is provided, the thermal disinfection system comprising a blood treatment apparatus (10), the blood treatment apparatus comprising a hydraulic circuit (100) for fluid transport, the hydraulic circuit (100) having:

[0105] - at least one dialysis supply line (107) extending from the fluid inlet (101) to a dialysis fluid supply outlet (130) connectable to an inlet of a dialyzer (150);

[0106] - a dialysis waste line (108) extending from a dialysate fluid return inlet (133) to a drain outlet (129), the dialysate fluid return inlet (133) being configured to be connected to an outlet of the dialyzer (150);

[0107] a heating unit (104) configured to heat a fluid within the hydraulic circuit (100), in particular water or a disinfectant solution or a dialysis fluid or a mixture thereof;

[0108] - at least one temperature sensor (127, 127', 128) configured to provide a signal representative of the temperature of the fluid in the hydraulic circuit (100);

[0109] - at least one pressure sensor (162) configured to provide a signal representative of the local atmospheric pressure;

[0110] The blood treatment device (10) comprises a control unit (500) configured to perform a thermal disinfection process of the hydraulic circuit (100), the thermal disinfection process comprising at least the following steps performed by the control unit (500):

[0111] - receiving a temperature signal from at least one temperature sensor (127, 127', 128) and determining a measured temperature value (T fluid_mes );

[0112] - receiving a pressure signal from at least one pressure sensor (162) and determining a measured local atmospheric pressure value (P atm );

[0113] -Based on the local atmospheric pressure value (P atm ) determines the set temperature of the fluid (T fluid_set ) to avoid boiling of the fluid in the hydraulic circuit (100), the set temperature (T fluid_set ) is comprised between 70°C and 105°C;

[0114] - Based on the determined set temperature (T fluid_set ) to calculate the estimated time to complete the thermal disinfection process (T est );

[0115] - Estimated time to complete the thermal disinfection process (T est ) and reference time (T ref ) for comparison;

[0116] - Based on the comparison results, continue the thermal disinfection process or recommend / start a different disinfection process, for example a chemical disinfection process.

[0117] In another aspect according to the preceding aspect, the different disinfection process requires less disinfection time than a thermal disinfection process, in particular, the different disinfection process is a chemical disinfection using a chemical disinfectant such as NaOCl. Alternatively, another disinfectant such as citric acid may be used.

[0118] Furthermore, a different sterilization process may also be based on heating a fluid including a chemical agent (ie it is a chemical and thermal sterilization).

[0119] In another aspect according to the first two aspects, the control unit (500) is configured to provide an indication on a user interface of the blood treatment device (10) recommending a different disinfection process and allowing the user to accept or reject the different disinfection process.

[0120] Alternatively, different disinfection processes can be started automatically.

[0121] In another independent aspect, a thermal disinfection system (1) comprises a blood treatment apparatus (10), the blood treatment apparatus comprising a hydraulic circuit (100) for fluid transport, the hydraulic circuit (100) having:

[0122] - at least one dialysis supply line (107) extending from the fluid inlet (101) to a dialysis fluid supply outlet (130) connectable to an inlet of a dialyzer (150);

[0123] - a dialysis waste line (108) extending from a dialysate fluid return inlet (133) to a drain outlet (129), the dialysate fluid return inlet (133) being configured to be connected to an outlet of the dialyzer (150);

[0124] a heating unit (104) configured to heat a fluid within the hydraulic circuit (100), in particular water or a disinfectant solution or a dialysis fluid or a mixture thereof;

[0125] - at least one temperature sensor (127, 127', 128) configured to provide a signal representative of the temperature of the fluid in the hydraulic circuit (100);

[0126] - at least one pressure sensor (162) configured to provide a signal representative of the local atmospheric pressure;

[0127] The blood treatment device (10) comprises a control unit (500) configured to perform a thermal disinfection process of the hydraulic circuit (100), the thermal disinfection process comprising at least the following steps performed by the control unit (500):

[0128] - receiving a temperature signal from at least one temperature sensor (127, 127', 128) and determining a measured temperature value (Tfluid_mes );

[0129] - receiving a pressure signal from at least one pressure sensor (162) and determining a measured local atmospheric pressure value (P atm );

[0130] -Based on the local atmospheric pressure value P atm Determine the set temperature (T fluid_set ) to avoid boiling of the fluid in the hydraulic circuit (100), the set temperature (T fluid_set ) is comprised between 70°C and 105°C;

[0131] - Driving the heating unit (104) to heat the fluid to a set temperature (T fluid_set ),

[0132] - Receive a set disinfectant dose (A) indicating the desired disinfection level 0_set );

[0133] - receiving a threshold temperature value (TT),

[0134] - Calculate the disinfection dose achieved during the disinfection process (A 0_achieved ), wherein the disinfection dose (A 0_achieved ) is based on the elapsed time (Δt) and a reference fluid temperature (T) measured by at least one temperature sensor (127, 127', 128; 303, 313, 323) ref ), the reference fluid temperature (T ref ) is essentially the lowest fluid temperature within the hydraulic circuit (100) during the thermal disinfection process, wherein when the reference temperature (T ref ) is equal to or exceeds the threshold temperature value (TT), calculate the achieved disinfection dose (A 0_achieved ) steps,

[0135] - The disinfection dose to be achieved (A 0_achieved ) and set disinfection dosage (A 0_set ) is compared, and based on the comparison, if the disinfection dose (A 0_achieved ) is equal to or exceeds the set disinfection dose (A 0_set ), the disinfection process stops.

[0136] In another aspect according to the preceding aspect, the local atmospheric pressure value (P atm ) through a predetermined relationship with the set temperature of the fluid (T fluid_set ), the predetermined relationship defines the boiling point temperature BPT as the local atmospheric pressure value (P atm ), where 0.9·BPT <T fluid_set<BPT, particularly where 0.9·BPT < T fluid_set <0.99·BPT, more particularly where 0.9·BPT < T fluid_set <0.96·BPT.

[0137] In a further aspect according to the first two aspects, the achieved disinfection dose (A) is calculated based only on the period of time during which the fluid measurement temperature of the fluid exceeds the threshold temperature value (TT). 0_achieved )

[0138] In a further aspect according to the first three aspects, the control unit (500) is configured to continuously update the measurement of the local atmospheric pressure (P) during the heat disinfection process, particularly during the entire period of the disinfection process, according to a predetermined sampling rate, the sampling rate being comprised between 0.01 Hz and 1000 Hz, particularly being comprised between 0.1 Hz and 500 Hz. atm ) at a sampling rate included between 0.01 Hz and 1000 Hz, particularly included between 0.1 Hz and 500 Hz.

[0139] In a further aspect according to the foregoing aspects, the control unit is further configured to update the set temperature (T atm ) during the disinfection process based on the measurement of the updated local atmospheric pressure (P fluid_set ).

[0140] In aspect 6 according to any one of the foregoing aspects, when driving the heating unit (104; 302) to heat the fluid based on the measured temperature value T fluid_mes and the measured local atmospheric pressure value P atm , the control unit (500) is configured to or the method comprises:

[0141] - determining the set temperature T atm of the fluid based on the local atmospheric pressure value P fluid_set , the set temperature T fluid_set optionally being included between 50 °C and 105 °C, particularly being included between 70 °C and 100 °C;

[0142] - controlling the heating unit (104; 302) based on the measured temperature value T fluid_mes to heat the fluid to the set temperature T fluid_set and particularly not exceeding that set temperature.

[0143] In aspect 7 according to any one of the foregoing aspects, the control unit (500) is further configured to or the method comprises:

[0144] - receiving a set disinfection dose A 0_set representing the required disinfection level;

[0145] - calculating the achieved disinfection dose A0_achieved .

[0146] In the 8th aspect according to any one of the foregoing aspects, the disinfection process further includes the achieved disinfection dose A 0_achieved compared with the set disinfection dose A 0_set and, based on the comparison, if the achieved disinfection dose A 0_achieved is equal to or exceeds the set disinfection dose A 0_set , the disinfection process is stopped.

[0147] In the 9th aspect according to any one of the foregoing aspects, the set disinfection dose value A 0_set is included between 40 and 2000, particularly between 200 and 1000, and more particularly between 500 and 950.

[0148] In the 9th aspect according to any one of the foregoing aspects, the set disinfection dose value A 0_set is set to a main acceptance level equal to 900, particularly corresponding to a temperature above 80 °C for 15 minutes, or is set to an auxiliary acceptance level equal to 600, particularly downstream of the dialyzer, or is set to a third acceptance level of 400.

[0149] In the 10th aspect according to any one of the foregoing aspects, the control unit (500) is configured or the method includes maximizing the set temperature T of the fluid atm based on the local atmospheric pressure value P fluid_set to avoid the fluid in the hydraulic circuit (100) boiling.

[0150] In the 11th aspect according to any one of the foregoing aspects, the local atmospheric pressure value P atm is related to the set temperature T of the fluid by a predetermined relationship fluid_set that defines the boiling point temperature BPT as a function of the local atmospheric pressure value P atm , particularly where 0.9·BPT < T fluid_set < BPT, and more particularly where 0.9·BPT < T fluid_set < 0.99·BPT, and even more particularly where 0.9·BPT < T fluid_set < 0.96·BPT.

[0151] In the 12th aspect according to any one of the foregoing aspects, the control unit (500) is configured or the method includes: continuously, periodically or randomly updating the local atmospheric pressure P during the thermal disinfection process, particularly during the entire time period of the disinfection process, according to a predetermined sampling rate atmFor measurements of the sampling rate, the sampling rate is comprised between 0.01 Hz and 1000 Hz, in particular between 0.1 Hz and 500 Hz.

[0152] In a 13th aspect according to any one of the preceding aspects, the control unit is configured to, based on the updated local atmospheric pressure P atm The measurement of T is used to update the set temperature during the sterilization process. fluid_set .

[0153] In a 14th aspect according to any one of the preceding aspects 1 to 11, the control unit (500) is configured to or the method comprises: measuring the local atmospheric pressure P by means of a pressure sensor (162; 362) at an initial stage of the disinfection process or just before the start of the thermal disinfection process atm In particular, the control unit (500) is configured to measure the local atmospheric pressure P only during the initial stage of the disinfection process. atm .

[0154] In a 15th aspect according to the preceding aspect, at the initial stage of the thermal disinfection process, the measured local atmospheric pressure P atm Set the fluid temperature T fluid_set , the set temperature of the fluid is T fluid_set Remains constant during the thermal disinfection process.

[0155] In a 16th aspect according to any one of the preceding aspects, the disinfection dose A achieved 0_achieved The calculation step is based on a reference fluid temperature T measured by at least one temperature sensor (127, 127', 128; 303, 313, 323). ref , in particular, assuming that the reference fluid temperature T ref Essentially the lowest fluid temperature within the hydraulic circuit (100) during the thermal disinfection process.

[0156] In a 17th aspect according to any one of the preceding aspects, the disinfection dose A achieved 0_achieved The number of computation steps is a function of the elapsed time.

[0157] In an 18th aspect according to any one of the preceding aspects, the disinfection dose A achieved 0_achieved The calculation step is based on a predetermined z value, which defines the relationship between the fluid temperature and the effectiveness of the disinfection process, the z value being optionally included between 5°C and 30°C, preferably z value = 10°C, in particular wherein the z value corresponds to the increase in fluid temperature required to reduce the D value of a specific microorganism by about 90%, the D value being the time required to kill about 90% of the corresponding microbial population at a given temperature.

[0158] In a 19th aspect according to any one of the preceding aspects, the disinfection dose A achieved 0_achieved Calculated by the following disinfection dosage formula:

[0159] A 0_achieved =∑10 (T(t)-80) / z ·Δt

[0160] wherein z=10° C., Δt is the time interval (in seconds) between measurements of at least one temperature sensor (127, 127′, 128; 303, 313, 323) controlled in particular by a control unit (500), and T=T ref is the reference fluid temperature measured by at least one temperature sensor (127, 127', 128; 303, 313, 323) during a time interval Δt.

[0161] In a 20th aspect according to the preceding aspect, the time interval is 0.001 s<Δt<100 s, particularly including 0.05 s<Δt<10 s.

[0162] In a 21st aspect according to any one of the preceding aspects, the hydraulic circuit (100) comprises at least one pump (120, 122; 450), and the control unit (500) is configured to activate the at least one pump (120, 122; 450) during the thermal disinfection process to determine the flow of the heating fluid within the hydraulic circuit (100).

[0163] In a 22nd aspect according to any one of the preceding aspects, the hydraulic circuit comprises a shunt tube (132a) connecting the dialysis fluid supply outlet (130) with the dialysate fluid return inlet (133) to bypass the dialyzer (150).

[0164] In a 23rd aspect according to any one of the preceding aspects, the hydraulic circuit (100) is configurable in a loop for recirculating the heating fluid at least during the sterilization process.

[0165] In a 24th aspect according to the previous aspects, the loop comprises at least a heating unit (104), at least one pump (120, 122; 450), at least one temperature sensor (127, 127', 128; 303, 313, 323), at least a portion of a dialysis supply line (107), at least a portion of a dialysis waste line (108), optionally one or more bypass lines (109, 109a), optionally a shunt tube (132a), wherein the one or more bypass lines fluidically connect the dialysis supply line (107) with the dialysis waste line (108).

[0166] In aspect 25 according to any one of the preceding aspects, the hydraulic circuit (100) comprises one or more valves (102, 121, 123, 124, 125, 126), the one or more valves being commandable by a control unit (500) between an open position and a closed position to respectively allow or block a fluid passage, the control unit (500) being further configured to command the one or more valves (102, 121, 123, 124, 125, 126) to define the loop for recirculating the heating fluid.

[0167] In a 26th aspect according to any one of the preceding aspects, the hydraulic circuit (100) comprises: a low temperature sensor (127'; 323) of the at least one temperature sensor (127, 127', 128; 303, 313, 323), arranged upstream of the heating unit (104), in particular the low temperature sensor (127'; 323) is arranged close to an inlet of the heating unit (104; 302), in particular on the dialysis supply line (107), optionally assuming that the fluid temperature measured by the low temperature sensor (127'; 323) is substantially the lowest fluid temperature in the hydraulic circuit (100), in particular wherein if the fluid flows in the loop, the fluid temperature measured by the low temperature sensor (127'; 323) is a reference temperature (T ref ).

[0168] In a 27th aspect according to any one of the preceding aspects, the hydraulic circuit (100) comprises a return fluid temperature sensor (128) of at least one temperature sensor (127, 127', 128), arranged on the dialysis waste line (108), optionally, the return fluid temperature sensor (128) is arranged as close as possible to the discharge outlet (129), preferably downstream of a return fluid pump (122) arranged on the dialysis waste line (108), wherein when the hydraulic circuit (100) is in an open configuration, the fluid temperature measured by the return fluid temperature sensor (128) is a reference temperature T for the disinfection dosage formula ref , wherein a heating fluid flows from an inlet (101) through a dialysis supply line (107) and a dialysis waste line (108) and flows to a discharge outlet (129).

[0169] In a 28th aspect according to any one of the preceding aspects, the hydraulic circuit (100) comprises a high temperature sensor (127; 303) of the at least one temperature sensor (127, 127', 128; 303, 313, 323), arranged downstream of the heating unit (104; 302), in particular the high temperature sensor (127; 303) is arranged close to an outlet of the heating unit (104; 302), in particular on the dialysis supply line (107), wherein the high temperature sensor (127; 303) is configured to detect a fluid temperature value T of the fluid. fluid_mes , the control unit (500) is configured to control the heating unit (104; 302) so that T fluid_mes =T fluid_set .

[0170] In a 29th aspect according to any one of the preceding aspects, the control unit (500) is configured to or the method comprises: controlling the heating power or energy provided to the fluid by the heating unit (104; 302) to achieve a desired fluid temperature T fluid_set , in particular wherein the heating unit (104; 302) comprises an electric heater whose power can be commanded by a control unit (500).

[0171] In a 30th aspect according to any one of the preceding aspects, when A corresponding to the disinfection process time period DPt 0_achieved ≥A 0_set The disinfection process is completed.

[0172] In a 31st aspect according to the preceding aspect, the control unit (500) is configured to or the method comprises: storing the time period DPt relative to the disinfection process in a memory, in particular a digital memory.

[0173] In a 32nd aspect according to any one of the preceding aspects, the control unit (500) is configured to or the method comprises: determining a start time of a subsequent disinfection process based on the time period DPt of a previous disinfection process.

[0174] In a 33rd aspect according to any one of the preceding aspects, the control unit (500) is configured to or the method comprises: receiving or storing a threshold temperature value TT, wherein when the measured temperature of the heating fluid is equal to or exceeds the threshold temperature value TT, calculating the achieved disinfection dose A 0_achieved The step of the sterilization process starts, in particular the measured temperature of the heated fluid is the fluid reference temperature T ref .

[0175] In a 34th aspect according to any one of the preceding aspects, the achieved disinfection dose A is calculated based only on the time period when the measured fluid temperature of the fluid exceeds the threshold temperature value TT. 0_achieved.

[0176] In a 35th aspect according to any one of the preceding aspects, the hydraulic circuit (100) comprises a treatment fluid preparation unit (110) connected to the dialysis supply line (107) and configured to mix water from the water inlet (101) with one or more concentrate solutions to prepare a dialysis fluid, the treatment fluid preparation unit (110) comprising one or more concentrate containers containing one or more concentrate solutions connected to the dialysis supply line (107).

[0177] In a 36th aspect according to the preceding aspects, the treatment fluid preparation unit (110) comprises a corresponding concentrate pump for concentrated solution delivery, and the treatment fluid preparation unit (110) further comprises at least one conductive unit (114, 118) configured to provide a signal representing a concentration of a solution in the dialysis fluid.

[0178] In a 37th aspect according to any one of the preceding aspects, the thermal disinfection system (1) comprises at least one user interface (501), in particular a graphical user interface (501), which is operably connected to the control unit (500) and is configured to receive a set disinfection dose value A from a user. 0_set , at least one information in the group consisting of a threshold temperature value TT, a z value and a sampling rate.

[0179] In a 38th aspect according to any one of the preceding aspects, the hydraulic circuit (100) comprises a disinfectant source configured to infuse a disinfectant solution within the circuit during, before or after a thermal disinfection process.

[0180] In a 39th aspect according to any of the preceding aspects, the dialysis supply line (107) is arranged to receive water from the water inlet (101) and to provide dialysis fluid to an input of the dialyzer (150) during a blood treatment procedure.

[0181] In a 40th aspect according to any one of the preceding aspects, the dialysis waste line (108) is configured to receive dialysate fluid from an outlet of the dialyzer (150).

[0182] In a 41st aspect according to any of the preceding aspects, the hydraulic circuit of the water purification device (300) comprises a hydraulic circuit of at least one pump (450), wherein the thermal disinfection process comprises the step of activating at least one pump (450) to determine the flow rate of hot water within the hydraulic circuit at least during the thermal disinfection process.

[0183] In a 42nd aspect according to any one of the preceding aspects, the hydraulic circuit (100) of the water purification apparatus (300) comprises a pre-treatment module (160) having a particle filter and an activated carbon bed, in particular wherein the particle filter is configured to remove particles such as clay, silt and silicon from incoming water and the activated carbon bed is configured to remove at least one of hypochlorite, chloramines and chlorine.

[0184] In a 43rd aspect according to any one of the preceding aspects, the hydraulic circuit (100) of the water purification device (300) comprises a reverse osmosis (RO) module (170) configured to remove at least one of microorganisms, pyrogens and ionic substances from water by the action of reverse osmosis, in particular wherein the reverse osmosis (RO) module (170) is arranged downstream of the pretreatment module (160).

[0185] In a 44th aspect according to any one of the preceding aspects, the hydraulic circuit of the water purification device (300) comprises a post-treatment module (180) configured to remove ions such as aluminum, lead, cadmium, chromium, sodium and / or potassium from incoming water, wherein the post-treatment module (180) comprises an electrodeionization device (EDI).

[0186] In a 45th aspect according to any one of the preceding aspects, when based on the measured temperature value T fluid_mes and the measured local atmospheric pressure value P atm When driving the heating unit (104) to heat the fluid, the control unit (500) is configured to:

[0187] -Based on the local atmospheric pressure value P atm Determine the set temperature T of the fluid fluid_set , the set temperature T fluid_set optionally comprised between 50°C and 105°C, in particular comprised between 70°C and 100°C;

[0188] - Based on the measured temperature value T fluid_mes Control the heating unit (104) to heat the fluid to a set temperature T fluid_set and in particular does not exceed the set temperature T fluid_set . BRIEF DESCRIPTION OF THE DRAWINGS

[0189] Some embodiments and aspects of the present invention will be described below with reference to the accompanying drawings, which are for illustration purposes only, in which:

[0190] - Figure 1 is a schematic diagram of a hydraulic circuit of a blood treatment device;

[0191] - Figure 2is a schematic diagram of an alternative embodiment of a hydraulic circuit of a blood treatment apparatus;

[0192] - Figure 3 It is a schematic diagram of the hydraulic circuit of the water purification equipment;

[0193] - Figure 4 is a schematic diagram of a disposable device for a peritoneal dialysis apparatus;

[0194] - Figure 5 It is a detailed view of the hydraulic circuit of the water purification equipment;

[0195] - Figure 6 shows the evolution of the time required to complete the thermal disinfection process as a function of the fluid temperature;

[0196] - Figure 7 is an exemplary graph of the temperature of the fluid within the hydraulic circuit as a function of elapsed time during a thermal disinfection process.

[0197] definition

[0198] In this detailed description, corresponding parts shown in the various figures are denoted by the same reference numerals. The figures may illustrate the invention by means of non-scale representations; therefore, parts and components shown in the figures that are relevant for the purpose of the invention may relate only to schematic representations.

[0199] Upstream and / or Downstream

[0200] The terms upstream and downstream refer to the direction of travel or trajectory of a fluid configured to flow within a fluid line during normal use of the device or during a sterilization process. DETAILED DESCRIPTION

[0201] Blood treatment equipment10

[0202] according to Figure 1 , the thermal disinfection system 1 comprises a dialysis device 10 having a hydraulic circuit 100: the hydraulic circuit 100 comprises a supply device 107a having at least one dialysis supply line 107, which is typically used to transport a fluid (particularly water or purified water) from an inlet 101 towards an inlet 152 of a dialyzer 150 during a dialysis treatment.

[0203] The hydraulic circuit 100 further comprises a return device 171 having at least one dialysis waste line 108 for conveying dialysate liquid (spent dialysate and / or liquid ultrafiltered from the blood through the semi-permeable membrane 151 of the dialyzer 150) from the outlet 153 of the dialyzer 150 toward the Figure 1 The outlet transport is schematically represented by 129.

[0204] The hydraulic circuit 100 cooperates with a blood circuit (not shown). With reference to the present invention, the specific structure of the blood circuit is not essential. Thus, possible embodiments of the blood circuit are briefly described, however, only by way of non-limiting example. The blood circuit includes a blood extraction line 155 which is designed to remove blood from a vascular access and is connected to the inlet of the main chamber or blood chamber of the dialyzer 150. The blood circuit also includes a blood return line 154 which is designed to return the treated blood to the vascular access and is connected to the outlet 154 of the main chamber of the dialyzer 150.

[0205] The main chamber of the dialyzer 150 communicates with the secondary chamber through a semi-permeable membrane 151 made, for example, of a hollow fiber type or a plate type.

[0206] During dialysis treatment, the dialysis supply line 107 is connected to the dialysis treatment fluid inlet 152 of the secondary chamber, while the dialysis waste line 108 is connected to the dialysis treatment fluid outlet 153 of the secondary chamber. The blood circuit may also include one or more air separators, for example, in the blood return line, upstream of the safety valve. Other air separators may be present in the blood circuit, such as being located along the blood extraction line. The dialysis machine 1 may also include one or more blood pumps, such as positive displacement pumps (such as peristaltic pumps), for example, on the blood extraction line of the blood circuit and optionally on the blood return line.

[0207] To control the fluid passage towards / from the dialyzer 150, a flow pump 120 and a suction pump 122 may be included, which are respectively located on the dialysis fluid supply line 107 and the dialysis waste line 108 and are also operatively connected to the control unit 500 of the dialysis machine 1. When preparing the fluid for treating a patient, purified water enters the feed device at the inlet 101. A heater 104 is also provided on the fluid supply line 107 and is operatively connected to the control unit 500: when the inlet valve 102 is opened, the heater 104 is configured to heat the water during the blood treatment procedure (i.e., at a temperature of about 37 °C): alternatively, the heater 104 is configured to heat the water at a higher temperature T (i.e., 65 °C < T < 100 °C) during the disinfection process. The heater may include a resistor configured to become hot due to the flow of current: the amount of heating energy or instantaneous power provided to the water by the heater 104 can be set by controlling the amount of current flowing through the resistor. Alternatively, the control unit 500 may be configured to periodically activate and deactivate the heater to provide a preset average heating energy to the water.

[0208] The purified and heated water can be collected in a tank 105 provided with an expansion tube 106 to allow the gas finally dissolved in the liquid to be released into the atmosphere.

[0209] The device may also include a therapeutic fluid preparation unit 110, which may be of any known type, for example including one or more concentrate containers (A-concentrate 111 and B-concentrate 115) and corresponding concentrate pumps (A-pump 112 and B-pump 116) for concentrate delivery, as well as at least a first conductive unit 114 and / or a second conductive unit 118.

[0210] Concentrate pumps 112, 116 are arranged in the delivery lines 112a, 116a in order to allow metered mixing of water and concentrate solution in the dialysis supply line 107. The concentrate pumps 112, 116 are driven based on a comparison between 1) a target conductivity value of the liquid mixture formed at the respective infusion point where the dialysis supply line 107 connects the delivery line 112a, 116a and 2) a conductivity value of the mixture measured by means of a respective conductivity sensor 114, 118 arranged in the dialysis supply line 107 downstream of the infusion point between the dialysis supply line 107 and the respective delivery line 112a, 116a. Instead of the conductivity sensors 114, 118, a concentration sensor may be provided on the dialysis supply line 107. In particular, a first concentrate may be mixed with purified water in the dialysis supply line and the fluid conductivity measured immediately by the sensor 114 downstream of the first infusion point. A second infusion point may be placed downstream of the first conductivity sensor 114, and the second concentrate is mixed with the fluid in the dialysis supply line. Thereafter, during the blood treatment procedure, the conductivity or concentration of the prepared treatment fluid may be measured with the second conductivity sensor 118 before being directed to the dialyzer 150. For example, the dialysis fluid may contain sodium ions, calcium ions, magnesium ions, and potassium ions, and the treatment fluid preparation unit 110 may be configured to prepare the dialysis fluid based on a comparison between a target conductivity value and an actual conductivity value of the dialysis fluid measured by the conductivity sensors 114, 118. The concentrate pumps 112, 116 are typically configured to control the concentration of specific ionic species in the dialysate. Typically, it is advantageous to control the sodium and bicarbonate concentrations of the dialysis fluid.

[0211] According to an embodiment, only one conductivity sensor 118 may be used to control the dialysis fluid preparation. The conductivity sensor 118 is placed on the supply device downstream of the infusion point of the first concentrate and the second concentrate. Of course, other kinds of treatment fluid preparation units 110 with a single or additional concentrate source and / or a single or more pumps may be used equivalently. In fact, the treatment fluid preparation unit 110 may be any known system configured for online preparation of dialysis fluid from water and concentrate.

[0212] The hydraulic circuit 100 also includes a supply fluid temperature sensor 127 that is operably connected to the control unit 500 and is configured to provide a signal representing the water temperature within the circuit. Temperature checks of the fluid are useful during standard blood treatment procedures and during the disinfection process of the fluid line, as described in more detail in the following description. The supply fluid temperature sensor 127 is arranged on the supply line 107. According to an embodiment, the temperature sensor 127 can be arranged downstream of the heater 104 to monitor the fluid outlet temperature. A second fluid supply temperature sensor 127' can also be provided on the supply line 107 and arranged upstream of the heater 104.

[0213] When treating a patient via the treatment fluid removable connector 138 , the treatment fluid outlet 130 of the dialysis supply line 107 may be connected to the fluid inlet 152 of the dialyzer 150 .

[0214] When the supply device 107a is disinfected, a disinfectant and / or a heating fluid is circulated in the dialysis supply line 107. In particular, the treatment fluid removable connector 138 of the dialysis supply line 107 is disconnected from the dialyzer 150 and connected to the supply tube parking connector 136 provided in the chassis of the dialysis machine. The supply recirculation loop 174 is designed to receive fluid from the supply tube parking connector 136 and to guide the fluid again to the supply device 107a, in particular to the dialysis supply line 107 at the first connection point 140 immediately downstream of the inlet valve 102 and upstream of the heater 104. With such a pipe configuration, an auxiliary fluid circuit path is defined, which allows the fluid to be recirculated in the closed loop path, the closed loop path including the supply recirculation loop 174 and at least a portion of the supply device 107a. In the case where the supply line 107 is provided with a second fluid supply temperature sensor 127', the second fluid supply temperature sensor 127' is interposed between the first connection point 140 and the inlet of the heater 104.

[0215] During the thermal disinfection process, water is supplied through the inlet 101 and heated to the desired disinfection temperature by the heater 104. For example, the heater can be commanded by the control unit 500 to heat the water to a temperature comprised between 70°C and 100°C. The flow pump 120 operates continuously to pump fluid in the auxiliary fluid circuit path. The heated water returns to the supply device 107a along the supply device 107a, the treatment fluid outlet 130, the treatment fluid supply tube 131, the supply tube parking connector 136 and the supply recirculation loop 174. In other words, the heated water is recirculated in the closed auxiliary fluid circuit path for a predetermined period of time sufficient to perform thermal disinfection on the portion of the hydraulic circuit upstream of the dialyzer 150.

[0216] A first return valve 123 is placed in the supply recirculation loop 174 for enabling and preventing, respectively, the circulation of fluid in the auxiliary fluid circuit path. The first return valve 123 is opened during thermal disinfection. Optionally, the disinfection efficiency during the thermal disinfection process can be improved by using a disinfectant mixed with water: hot water mixed with the disinfectant solution determines an improvement in disinfection and can allow a reduction in the time required to reach a set disinfection threshold.

[0217] In an alternative embodiment, the heater 104 may be disposed in the supply recirculation loop 174 to heat the water in the loop path. In addition, as previously described, a first heater may be disposed on the supply line 107 and a second heater may be disposed on the supply recirculation loop 174.

[0218] The hydraulic circuit 100 also includes a return device 171, which is arranged to remove the dialysis fluid from the dialyzer 150 during the dialysis treatment and send it to the outlet 129. The dialysis waste line 108 can be provided with a corresponding return fluid removable connector 139, which is configured to be removably connected to the fluid outlet 153 of the dialyzer 150 when treating the patient to receive the dialysate fluid and guide it to the outlet 129. The outlet is suitable for connection to a waste bag or a drain. A suction pump 122 and a second flow meter (not shown) are arranged on the dialysis waste line 108. The first flow meter and the second flow meter can be used to control the fluid balance of the patient connected to the blood circuit during the dialysis treatment procedure (in a known manner). A conductivity sensor (not shown) can be arranged on the dialysis waste line 108, immediately downstream of the dialyzer 150, to measure the conductivity of the dialysate.

[0219] In addition, a return fluid temperature sensor 128 is also arranged on the dialysis waste line 108 to measure the temperature of the fluid circulating in the return device 171: the return fluid temperature sensor 128 is preferably arranged downstream of the suction pump 122. A first outlet valve 125 is placed in the return device 171 immediately upstream of the outlet 129 for allowing or preventing the fluid of the return device from being directed to the outlet.

[0220] During the disinfection process, a heating fluid (optionally mixed with a disinfectant solution) circulates in the dialysis waste line 108. In particular, the return fluid removable connector 139 of the dialysis waste line 108 is disconnected from the dialyzer 150 and connected to a return tube parking connector 137 provided in the chassis of the dialysis machine. The return recirculation circuit 173 is designed to receive fluid from the return tube parking connector 137 and to direct the fluid again to the return device 171, in particular to the dialysis waste line 108 at the fourth connection point 143 immediately upstream of the outlet 129, and preferably to the first outlet valve 125. With such a piping configuration, a fluid circuit path is defined that allows the fluid to be recirculated in a closed loop path, which includes the return recirculation circuit 173 and at least a portion of the return device 171. In an embodiment (not shown), only a fluid circuit path is given to recirculate the fluid, in particular during the disinfection process; the auxiliary fluid circuit path is not present in the "clean side" of the hydraulic circuit. In this embodiment, no supply recirculation circuit is provided. In the case of heat sterilization only, hot water heated to a desired sterilization temperature by the heater 104 is supplied to the fluid circuit path through the supply device 107a. For example, water with a temperature of 70-100 degrees can be used.

[0221] It should be noted that hot water can be Figure 1 The bypass line 109 shown or any other fluid connection between the dialysis supply line 107 (including the heater 104) and the fluid circuit path is provided. Alternatively or in combination, an additional heater (not shown) may be provided in the return device 171 or in the return recirculation loop 173 to heat the water.

[0222] In another embodiment, a heat exchanger may be used to transfer heat from the fluid in the supply 107a to the fluid in the return 171 to achieve a desired temperature of the fluid in the fluid loop path. An additional heater in the return may or may not be present.

[0223] During the thermal disinfection process, the control unit 500 commands the suction pump 122 to continuously pump the fluid in the fluid circuit path. In particular, the heated water passes through the return device 171, the return recirculation circuit 173, the return tube parking connector 137, the treatment fluid return tube 132, the dialysate fluid return inlet 133, and returns to the return device 171. In other words, the heated water is recirculated in the closed fluid circuit path for a predetermined period of time sufficient to perform thermal disinfection on the hydraulic circuit portion downstream of the dialyzer 150. The second return valve 124 is placed in the return recirculation circuit 173 for enabling or preventing the fluid from circulating in the fluid circuit path. The second return valve 124 is opened during thermal disinfection. It is worth noting that disinfection of the fluid circuit path can alternatively be obtained using a disinfectant mixed with water; disinfection can be achieved in combination with or without heating of the disinfectant solution.

[0224] according to Figure 1 The hydraulic circuit 100 also includes a forward supply device 172 arranged so that the fluid of the supply device 107a can bypass the fluid circuit path (i.e. bypass the portion of the return device 171 upstream of the first outlet valve 125 and bypass the return recirculation loop 173) and be fed forward to a waste bag or drain. Figure 1 In an embodiment of the present invention, the forward supply device 172 is connected to the dialysis supply line 107 or the bypass line 109 on one side and directly connected to the outlet 129 of the return device 171 on the other side. However, it should be noted that the forward supply device 172 can be directly connected to the discharge port (or waste bag) without being connected to the return device 171. In other words, in some embodiments, the forward supply device 172 can have an independent discharge end and is not directly connected to other lines of the hydraulic circuit and can be freely placed.

[0225] Figure 1 The forward supply device 172 is connected to the auxiliary fluid circuit path (in particular to the supply device 107a) at the second connection point 141. Fluid from the auxiliary fluid circuit path can be extracted at the second connection point 141 and directed to the outlet 129 without circulating in the fluid circuit path before being discharged. In particular, in the example, the forward supply device 172 is connected to the return device 171 at the sixth connection point 145 located downstream of the fourth connection point 143, wherein the return recirculation loop 174 is connected to the return device 171.

[0226] The forward feed device 172 comprises a second outlet valve 126 for enabling or preventing the fluid of the feed device from being directed to the outlet through said forward feed device.

[0227] The hydraulic circuit 100 may further include: a bypass line 109 connecting the dialysis fluid supply line 107 and the dialysis waste line 108, bypassing the dialyzer 150; and one or more bypass valves 121 connected to the control unit 500 for selectively opening and closing the bypass line 109. The bypass valve 121 is opened according to the command of the control unit; in addition, the control unit 500 closes the fluid passage toward the treatment area and directly connects the inlet 101 to the dialysis waste line 108 through the bypass line 109.

[0228] exist Figure 1 In the example of FIG. 1 , the first channel of the bypass line 109 between the second connection point 141 and the fifth connection point 144 is common to the forward supply device 172. In other words, by appropriately controlling the opening / closing of the bypass valve 121 and the second outlet valve 126, the fluid can be directed from the supply device 107a toward the return device 171 or toward the outlet 129. In addition, both the bypass valve 121 and the second outlet valve 126 can be opened at the same time, whereby the fluid from the supply device 107a can be directed both toward the return device 171 and toward the outlet 129. The bypass line 109 is connected to the return device 171 at the third connection point 142 upstream of the suction pump 122.

[0229] according to Figure 2 In another embodiment shown, the hydraulic circuit 200 may include a shunt tube 132a that directly connects the treatment fluid outlet 130 of the supply line 107 with the dialysate fluid return inlet 133 of the dialysis waste line 108 during the thermal disinfection process. During the thermal disinfection process, hot water passes through the supply line 107, the shunt tube 132a, the waste line 108 and toward the outlet 129. In addition, the hydraulic circuit 100 may be provided with an auxiliary bypass line 109a that connects the waste line 108 at the connection point 147 upstream of the outlet 129 with the supply line 107 at the connection point 140. In this configuration, during the thermal disinfection process, hot water passes through the supply line 107, the shunt tube 132a, the waste line 108 and through the auxiliary bypass line 109a, thereby defining a circuit path for recirculating the hot water.

[0230] The dialysis device further comprises a pressure sensor 162 configured to provide a signal representative of the atmospheric pressure surrounding the dialysis device. The pressure sensor 162 is operably connected to a control unit 500 configured to receive a representative pressure signal from the pressure sensor 162 and provide an atmospheric pressure value in an output.

[0231] The device may also include a user interface 501 (e.g., a graphical user interface or GUI) operably connected to the control unit 500. For example, the control unit 500 may include one or more digital microprocessor units or one or more analog units or other combinations of analog units and digital units. As an example, with respect to a microprocessor unit, once the unit has executed a special program (e.g., a program from the outside or directly integrated on a microprocessor card), the unit is programmed, defining a plurality of functional blocks that constitute means each designed to perform a corresponding operation.

[0232] The control unit 500 of the dialysis device 1 is connected to a (graphical) user interface 501, via which the control unit can receive instructions, for example target values, such as a set temperature T of the fluid. fuid_set , threshold temperature TT and set disinfection dose A 0_set , as described in more detail in the thermal disinfection process section. The (graphic) user interface 501 may also receive instructions for executing a treatment procedure (ie, a blood treatment procedure): that is, the user interface 501 may receive a blood flow rate Q b , dialysis fluid flow rate Q di , Infusion fluid flow rate Q inf (where appropriate), patient weight loss WL. The control unit 500 may also receive values ​​detected by sensors of the device, such as the above-mentioned flow meter, the conductivity sensor of the treatment fluid preparation unit 110 and the conductivity sensor in the dialysis waste line 108, and the first and second supply fluid temperature sensors 127, 127' and the return fluid temperature sensor 128. Based on the received instructions and the programmed operating modes and algorithms, the control unit 500 drives the actuators of the device, such as the blood pump, the above-mentioned flow pump 120 and the suction pump 122, and the treatment fluid preparation unit 110, to perform a blood treatment procedure or to perform a disinfection process. The control unit 500 may also provide information about the thermal disinfection process of the hydraulic circuit 100 (e.g., treatment parameters and machine parameters) to the user via the (graphical) user interface 501.

[0233] Water purification equipment 300

[0234] according to Figure 3 , Figure 4 and Figure 5 In another embodiment shown, the thermal disinfection system 1 includes a water purification device 300 that can be fluidically connected to one or more medical devices (i.e., a peritoneal dialysis device or a blood treatment device) to provide purified water. In particular, this embodiment covers both a water purification device 300 that can be connected to a medical device (wherein no medical device is included) and a medical device that includes the water purification device 300 (in particular, a peritoneal dialysis device or the previously described blood treatment device 10).

[0235] In particular, the water purification device 300 can be fluidly connected to the inlet 101 of the previously described blood treatment device 10 to provide purified water. Alternatively, the water purification device 300 can be fluidly connected to the disposable device 40 of the peritoneal dialysis device (see Figure 4 ).

[0236] A detailed description of the internal circuit of the water purification device 300 is not essential for the purpose of the present invention: in any case, Figure 3 and Figure 5 As shown, an exemplary embodiment of a water purification device 300 that can be connected to a peritoneal dialysis device is described below.

[0237] The water purification device 300 includes at least one of a pre-treatment module 160, a reverse osmosis (RO) module 170, and a post-treatment module 180: Figure 3 An exemplary embodiment of the main functional parts of the water purification apparatus 300 is shown, including a pre-treatment module 160 , a reverse osmosis (RO) module 170 , and a post-treatment module 180 .

[0238] The water purification apparatus 300 includes an inlet port 399 for supplying water from a water source 398 (eg, a tap) into the water purification apparatus 300 to purify the water. Influent water from the water source is supplied to the pre-treatment module 160 through the inlet port 399.

[0239] The pretreatment module 160 treats the incoming water with a particle filter and an activated carbon bed. The particle filter is arranged to remove particles such as clay, silt and silicon from the incoming water. The particle filter is arranged to block micron-sized particles (optionally larger endotoxin molecules) in the incoming water. The activated carbon bed is arranged to remove chlorine and chlorine-containing compositions from the incoming water and absorb toxic substances and pesticides. In an exemplary embodiment, the activated carbon bed is arranged to remove one or more of hypochlorite, chloramine and chlorine. In another exemplary embodiment, the activated carbon bed is also arranged to reduce organic compounds (TOC total organic carbon) including pesticides of the incoming water. In some embodiments, the particle filter and the activated carbon bed are integrated into a single consumable part. Consumable parts are replaced at predetermined intervals, for example, according to the quality of the incoming water. For example, before the water purification device 300 is used for the first time at the care point, the quality of the incoming water is checked and determined by a qualified person.

[0240] Optionally, the pretreatment module 160 includes an ion exchange device for protecting devices located downstream, such as reverse osmosis RO membranes and polishers. Therefore, the pretreatment module 160 filters the incoming water and delivers the pretreated water to the RO module 170 located downstream. The RO module 170 removes impurities, such as microorganisms, pyrogens and ionic substances from the pretreated water, from the filtered water by the action of reverse osmosis. The pretreated water is pressurized by a pump and forced to pass through the RO membrane to overcome the osmotic pressure. The RO membrane is, for example, a semipermeable membrane. Thus, the water flow of the pretreated water, which is referred to as the supply water, is divided into a waste water flow and a permeate water flow. In an exemplary embodiment, the waste water can pass through one or both of the first waste path and the second waste path. The first waste path recycles the waste water back to the supply fluid path of the RO pump so that it is supplied back to the RO device again. The recycled waste water increases the supply flow to the RO device to obtain sufficient flow through the waste side of the RO membrane, thereby minimizing the scaling and contamination of the RO membrane. The second waste path guides the waste water discharge. This keeps the concentration level on the reject side low enough to obtain the appropriate, desired permeate fluid concentration.If the feed water has a low content of solutes, a portion of the discharge flow can also be directed back to the inlet side of the RO membrane, thereby improving the water efficiency of the water purification device 300.

[0241] Therefore, the RO module 170 processes the pretreated water and transports the permeate water to the post-processing module 180 located downstream. The post-processing module 180 polishes the permeate water so as to further remove ions from the permeate water. The permeate water is polished using a polisher device (such as an electrodeionization EDI device or a mixed bed filtration device). The EDI device utilizes electrodeionization to remove ions that have penetrated the RO membrane, such as aluminum, lead, cadmium, chromium, sodium and / or potassium, from the permeate water. The EDI device utilizes electricity, ion exchange membranes and resins to deionize the permeate water and separate dissolved ions, i.e., impurities, from the permeate water. The EDI device produces polished water, which is polished by the EDI device to a purity level higher than the purity level of the permeate water. EDI has an antibacterial effect on the product water, and due to the electric field in the EDI device, etc., the amount of bacteria and endotoxins in the water can be reduced. The mixed bed filtration device includes a column or container with a mixed bed ion exchange material.

[0242] Thereafter, the purified water (also referred to as product water) is ready to be delivered to the point of use of the product water from the product port 328 of the water purification device 300. The product water is suitable for dialysis, i.e., for hemodialysis or peritoneal dialysis. In another embodiment, the product water can be used for injection into the patient's bloodstream.

[0243] Optionally, the water purification device 300 includes a discharge port 318. In an example embodiment, the discharge port 318 is used to receive used fluid, such as from a PD patient, via the discharge line 64 for further delivery to a discharge port 339 of the water purification device 300 via a first discharge path 384 within the water purification device 300. As another option, the discharge port 318 receives a sample of the mixed solution for further delivery to a conductivity sensor disposed in the water purification device 300 (e.g., disposed in the first discharge path 384).

[0244] In an example embodiment, Figure 4 The illustrated disposable tubing set 40 for peritoneal dialysis may be fluidly connected to the product port 328 of the water purification apparatus 300 to receive purified water.

[0245] The disposable device 40 includes a water inlet 66a ( Figure 2 ) of the upstream water line section 64a. The downstream water line section 64b is connected to the water outlet 66b ( Figure 2 ) extends to the cassette 42. In the illustrated embodiment, the upstream water line segment 64a begins at a water line connector 68, which is located upstream of the water reservoir 66 and is configured to connect to a product port 328 of the water purification device 300. The water purification device 300 outputs purified water and water suitable for, for example, peritoneal dialysis ("WFPD"). WFPD is water suitable for making dialysis fluid for delivery to the peritoneal cavity of the patient P.

[0246] In one embodiment, the sterilizing grade filter 70a is placed upstream of the downstream sterilizing grade filter 70b. The filters 70a and 70b can be placed in the water line section 64a upstream of the water reservoir 66. The sterilizing grade filters 70a and 70b can be straight-through filters without a waste line. The pore size of the sterilizing grade filter can be, for example, less than one micron, such as 0.1 micron or 0.2 micron. Suitable sterilizing grade filters 70a and 70b can be, for example, Pall IV-5 or GVS Speedflow filters, or filters provided by the assignee of the present disclosure. In an alternative embodiment, only one or more than two sterilizing grade filters are placed in the water line section 64a upstream of the water reservoir 66. One or more sterilizing grade filters can be arranged close to the water reservoir 66 so that the fluid line device 40 becomes easier to fold. In another alternative embodiment, there is no sterilizing grade filter in the water line section 64a. The sterilizing grade filter may be replaced, for example, by one or more ultrafilters located in the product fluid path of the water purification apparatus 300 .

[0247] The disposable tubing set 40 includes a patient line 50 extending from a patient line port of the cassette 42 and terminating in a patient line connector 52 to be connected to a patient. The patient line connector 52 is connected to a patient transfer set 54, which in turn is connected to an indwelling catheter located in the peritoneal cavity of the patient. The disposable tubing set 40 also includes a drain line 56 extending from a drain line port of the cassette 42 and terminating in a drain line connector 58. The drain line connector 58 can be removably connected to the drain port 318 of the water purification apparatus 300.

[0248] The disposable set 40 also includes a final bag or sample line 72 extending from the final bag or sample port of the cassette 42. The final bag or sample line 72 terminates in a connector 74 that can be connected to a mating connector of a premixed final fill bag of dialysis fluid or to a sample bag or other sample collection container. If desired, the final bag or sample line 72 and connector 74 can alternatively be used for a third type of concentrate.

[0249] The disposable device 40 includes a first concentrate line 76 extending from a first concentrate port of the cartridge 42 and terminating at a first cartridge concentrate connector 80a. The first cartridge concentrate connector 80a is configured to be fluidly connected to a first concentrate container 84a holding a first concentrate (e.g., a glucose concentrate). The second concentrate line 78 extends from a second concentrate port of the cartridge 42 and terminates at a second cartridge concentrate connector 82a. The second container concentrate connector 82b is configured to be fluidly connected to a second concentrate container 84b holding a second concentrate (e.g., a buffer concentrate).

[0250] In an embodiment, to begin treatment, patient P loads cartridge 42 into the circulator and, in a random or specified order: (i) places heater / mixing bag 62 onto the circulator, (ii) connects upstream water line segment 64a to product port 328 of water purification apparatus 300, (iii) connects drain line 56 to drain port 318 of water purification apparatus 300, (iv) connects first cartridge concentrate connector 80a to first container concentrate connector 80b, and (v) connects second cartridge concentrate connector 82a to second container concentrate connector 82b. Figure 5 A detailed embodiment of a water purification apparatus 300 is shown.

[0251] Figure 5 The line type difference of the fluid paths of FIG. 1 shows the main flow in the first fluid path (thicker line) and the second fluid path (double dotted line) during general disinfection. Figure 5, the RO device 301 is arranged to produce a purified fluid flow and a waste fluid flow. In more detail, the RO device 301 includes a supply inlet 301a, a permeate outlet 301b and a waste outlet 301c. The RO membrane 324 separates the supply inlet 301a and the waste outlet 301c from the permeate outlet 301b. The supply fluid path 391 is connected to the supply inlet 301a so that the supply fluid is delivered to the supply inlet 301a. The supply fluid path 391 is arranged with a tank 350 for collecting fluid and an RO pump 450 arranged to pump the supply fluid to the supply inlet 301a. The RO pump 450 is arranged downstream of the tank 350. The RO pump 450 is configured to be controlled by a control unit to a specific pump speed corresponding to a specific flow rate of the permeate fluid.

[0252] The water purification device 300 also includes a purification fluid path 371, which is connected to the permeate outlet 301b and the product port 328 so that the purified fluid is transported from the permeate outlet 301b to the product port 328. The purification fluid path 371 includes a permeate fluid path 371a, a polisher fluid path 371b and a product fluid path 371c. The polisher fluid path 371b includes a polisher device 306, such as an EDI device or a mixed bed filtration device. The bypass path 371d is arranged to bypass the polisher device. The three-way valve 305c is arranged to be controlled by the control unit 500 to selectively guide the permeate fluid flow into the polisher device 306, or to guide it into the bypass path 371d so as to bypass the polisher device 306. The first discharge path 384 is connected to the discharge port 318 and the discharge port 339 so that the fluid is passed from the discharge port 318 to the discharge port 339. The first discharge path 384 is implemented as a part of the circulator discharge path present in the water purification device 300. The first discharge path is arranged to convey discharged PD solution from a patient to a discharge port 339 of the water purification apparatus 300 , for example.

[0253] The water purification device 300 is also provided with a heating unit 302 (also referred to as a heater 302), which is arranged to heat the purified fluid produced by the RO device 301 downstream of the RO device 301. The heater 302 may, for example, include a heating element. The first recirculation path 381 is arranged to circulate the heated purified fluid from the point downstream of the RO device 301 and the heater 302 downstream to the supply fluid path 391 upstream of the pump 450 and the heater 302 inside the water purification device 300. The heated purified fluid is recycled to the tank 350 here and is supplied to the supply inlet 301a of the RO device 301 again. However, the heated purified fluid is instead directly recycled to the fluid line upstream of the RO pump 450. The waste stream is supplied back to the supply fluid path 391 via the first waste path 385b. The first waste path 385b is connected and fluidly communicated with the waste outlet 301c and the supply fluid path 391. The second waste path 389 is connected and fluidly communicated with the waste outlet 301c of the tank 350. However, the second waste path 389 is instead connected to and in fluid communication with the supply fluid path 391. The second discharge path 388 may be arranged to supply the waste fluid from the waste outlet 301c to the discharge port 339. The valve 305b (i.e., a three-way valve) is arranged to selectively direct the waste flow into the second waste path 389 or the second discharge path 388. The constant flow device 318 is arranged to control the flow rate in the second waste path upstream of the three-way valve 305b.

[0254] The water purification device 300 may include a second recirculation path 375 arranged with a flow control device 305a. In an exemplary embodiment, the second recirculation path 375 is referred to as a second fluid path. The second recirculation path 375 is arranged to transport the heated purified fluid within the water purification device 300. In an exemplary embodiment, the second discharge path 388 is also referred to as a second fluid path.

[0255] The control unit 500 is configured to perform the thermal disinfection process of the water purification equipment 300. This means that the cleaning of all or part of the fluid path of the RO module 170 and the post-processing module 180 of the water purification equipment 300 in contact with the fluid is controlled. The fluid path is intended to include the pipe, pipeline, channel, port, tank, such as valve, control device, etc. of the water purification equipment 300. The control unit 500 is configured to make the water purification equipment 300 control the heating of the purified fluid from the RO device 301 by the heater 302. The heater 302 includes, for example, a heating rod. In an example embodiment, a part of the permeate fluid path 371a is wound around the heating rod so as to effectively heat the purified fluid in the permeate fluid path 371a. Alternatively, the heater 302 includes a heat exchanger, which is arranged to exchange heat between the heating medium and the fluid in the permeate fluid path 371a. In one embodiment, the heater 302 is configured to heat the purified fluid at a certain heating rate. By controlling the power to the heater 302, and thereby the power to the heater, the heating rate of the heater 302 can be adjusted. However, the heating rate also depends on the flow rate of the purge fluid.

[0256] The valve device 305 is arranged to direct the heated purified fluid into the first fluid path or the second fluid path. The valve device 305 includes, for example but not limited to, one or more of the following: a flow control device 305a, a three-way valve 305b, a three-way valve 305c, and a product water valve 305d.

[0257] The water purification device 300 comprises one or more temperature sensors 303 , 313 , 323 .

[0258] The temperature sensor 303 is arranged to measure the temperature of the water downstream of the heater 302: in particular, the temperature sensor 303 is arranged close to the outlet of the heater 302, so that the water temperature can be assumed to be the maximum temperature of the water within the circuit. When the heated permeate fluid is directed to the first recirculation path 381, the temperature of the heated permeate fluid indicates the temperature of the fluid in the first recirculation path 381. The temperature sensor 303 may also be referred to as a high temperature sensor 303. In addition, a product fluid temperature sensor 313 may be arranged downstream of the EDI device 306 to measure the temperature of the water, thereby measuring the temperature of the fluid in the product fluid path 371c. In addition, a product fluid temperature sensor 323 may be arranged upstream of the heating unit 302: in particular, the temperature sensor 323 is arranged close to the inlet of the heating unit 302, so that the water temperature can be assumed to be the minimum temperature of the water within the circuit. The temperature sensor 323 may also be referred to as a low temperature sensor 323.

[0259] The flow sensor 410 is arranged to measure the flow rate of the purified fluid. The flow sensor 410 is here arranged to the fluid path 371a and is arranged to measure the flow rate of the permeate fluid from the RO device 301. The flow sensor 410 is arranged downstream of the permeate outlet 301b and upstream of the heater 302, for example directly downstream of the RO device 301.

[0260] For cleaning the water purification device 300, the control unit 500 is configured to control the valve arrangement 305 to recirculate the heated purification fluid in the first fluid path, eg the first recirculation path 381, until a first temperature-related criterion is met.

[0261] Water purification equipment 300 or peritoneal dialysis equipment also includes pressure sensor 362, which is configured to provide a signal representing the atmospheric pressure around the dialysis equipment. Pressure sensor 362 is operably connected to control unit 500, and the control unit is configured to receive representative pressure signals from pressure sensor 362 and provide atmospheric pressure values ​​in output. The peritoneal dialysis equipment of the above-described embodiment may also include a user interface 501 (such as a graphical user interface or GUI) operably connected to control unit 500, which is similar to or equal to the user interface 501 of the previously described blood treatment equipment 10. For example, control unit 500 may include one or more digital microprocessor units or one or more analog units or other combinations of analog units and digital units. As an example, about microprocessor unit, once the unit has performed a special program (such as, from outside or directly integrated on a microprocessor card), the unit is programmed, thereby defining a plurality of functional blocks constituting each device designed to perform corresponding operations.

[0262] Thermal disinfection process

[0263] The present invention relates to a thermal disinfection system 1, which is configured to perform a disinfection process of a hydraulic circuit of a medical device 10 (such as the previously described blood treatment device 10). Alternatively, the thermal disinfection system 1 is configured to perform a disinfection process of a purified water system 300, which, according to the above description, can be fluidically connected to one or more medical devices to provide water: the medical device can be one or more blood treatment devices 10 or a home peritoneal dialysis device. Still in an alternative embodiment, the thermal disinfection system 1 is configured to perform a disinfection process of a peritoneal dialysis device, in particular a disinfection process of a fluid line of a peritoneal dialysis device, wherein the fluid line can include an operating fluid line or a disposable fluid line inside the peritoneal dialysis device.

[0264] The disinfection process comprises at least the following steps: receiving temperature signals from the temperature sensors 127, 127', 128; 303, 313 and determining a measured temperature value T of the fluid in the hydraulic circuit 100;fluid_mes In addition, the heat disinfection process includes the following steps: receiving a pressure signal from the pressure sensors 162; 362, and determining the measured local atmospheric pressure value P atm , and driving the heating unit 104; 302 based on the measured temperature value T fluid_mes and the measured local atmospheric pressure value P atm to heat the fluid.

[0265] The heat disinfection process further includes determining a set temperature T of the fluid based on the local atmospheric pressure value P atm , where the set temperature is included between 50 °C and 105 °C, particularly between 70 °C and 100 °C. Thus, the heat disinfection process includes controlling the heating unit 104; 302 based on the measured temperature value T fluid_set to heat the fluid to the set temperature T fluid_mes and particularly not exceeding the set temperature T fluid_set . In particular, the control unit 500 is configured to compare the measured temperature value T fluid_set with the set temperature T fluid_mes , calculate the difference between the measured temperature value T fluid_set and the set temperature T fluid_mes , and control the heating unit 104; 302 based on the difference to heat the fluid to the set temperature T fluid_set and particularly not exceeding the set temperature T fluid_set . fluid_set

[0266] The local atmospheric pressure value P atm is related to the set temperature T of the fluid by a predetermined relationship: this relationship defines the boiling point temperature BPT as a function of the local atmospheric pressure value P fluid_set . For example, water at a local pressure of 1 ATM has a boiling point temperature BPT equal to 100 °C: according to the well-known relationship, a decrease in the local temperature determines a decrease in the boiling point temperature BPT. According to the present invention, the set temperature T of the fluid atm can be included between the limits of 0.9·BPT < T fluid_set < BPT, more particularly 0.9·BPT < T fluid_set < 0.99·BPT, more particularly 0.93·BPT < T fluid_set < 0.97·BPT. fluid_set

[0267] It is noted that the heat disinfection process aims to maximize the set temperature T of the fluid based on the local atmospheric pressure value P atm , thereby avoiding boiling of the fluid within the hydraulic circuit 100. For example, if the local pressure is 1 ATM, the set temperature T of the fluid fluid_set , then fluid_set ​The temperature will be heated as close to 100° C. as possible: higher temperatures will be avoided in order to prevent boiling of the fluid within the hydraulic circuit 100 which could cause damage to the circuit itself or determine a poor disinfection efficiency.

[0268] The thermal disinfection process may comprise continuously updating the local atmospheric pressure P during the thermal disinfection process according to a predetermined sampling rate comprised between 0.01 Hz and 1000 Hz, in particular comprised between 0.1 Hz and 500 Hz. atm The continuous updating may be periodic or random in time, or based on a preset algorithm. Similarly, a thermal disinfection process may include a measurement step based on the local atmospheric pressure P during the disinfection process. atm The set temperature T is continuously updated by updating the measurement fluid_set Steps: In other words, if the local atmospheric pressure P atm During the sterilization process, the set temperature T fluid_set will change accordingly. In this way, if the local atmospheric pressure P atm increases during the sterilization process, then the set temperature T fluid_set It will also increase, resulting in a reduction in the time required to perform the disinfection process, as described in more detail below.

[0269] Alternatively, the thermal disinfection process may include measuring the local atmospheric pressure P by means of the pressure sensor 162, 362 only during the initial phase of the disinfection process or just before the thermal disinfection process begins. atm Steps: Therefore, the set temperature T of the fluid fluid_set Also at the beginning of the thermal disinfection process, the measured local atmospheric pressure P atm and remain constant during the entire thermal disinfection process. In this case, pressure fluctuations during the disinfection process are not taken into account and the temperature T is set fluid_set Nor will it change.

[0270] According to the ISO 15883-1:2009 standard “Cleaner-disinfectors – Part 1: General requirements, terms and definitions”, cleaning is defined as “the removal of contaminants from items to the extent necessary for their further processing and their intended subsequent use”. Disinfection is specified by reference to the time and temperature of thermal disinfection. According to the standard, thermal disinfection is preferred whenever practical because it is easier to control and avoids hazards to staff, patients and the environment that may occur through the use of chemical disinfectants.

[0271] The definition of a thermal disinfection process can be achieved by the "A0" method, which uses the knowledge of the lethality of a specific process at different temperatures to evaluate the overall lethality of the cycle and express it as an equivalent exposure time at a specified temperature. The term "A" (also known as the disinfectant dose) is defined as the equivalent time in seconds at 80°C that produces a certain disinfection effect on a microorganism with a defined "z" value, where the "z" value is a measurement of the temperature relationship of the killing process expressed in °C. Based on this definition, the "z" value corresponds to the temperature increase required to reduce the "D" value of a specific microorganism by 90%: the "D" value is the time required to kill 90% of the corresponding microbial population at a given temperature (a ten-fold reduction in time). Therefore, the "z" value of a microorganism increases as the resistance of the organism grows. Bacterial spores are the most resistant of all microorganisms, with an average value of z = 10°C. This z value is also used in the "A0" concept, despite the fact that spores are not an explicit target for thermal disinfection. However, when defining disinfection parameters, the choice of the "z" value can be considered as a safety reserve. In the case where z = 10°C, the term "A0" is used instead of "A". A given "A0" value can be achieved with the most different temperature / time combinations.

[0272] The mathematical formula used to calculate A0 is as follows:

[0273] A0=∑10 (T(t)-80) / z ·Δt [1]

[0274] Wherein, "A0" is the value of "A" when z = 10°C; Δt is the selected time interval in seconds; T is the fluid temperature in °C measured at time "t". The lower temperature limit of the integration is set to 65°C. Therefore, A0 is a time-dependent unit that depends on temperature. As an example, A0 = 600 can be achieved by 10 minutes at 80°C, or by 1 minute at 90°C, or by 100 minutes at 70°C. Figure 6 A graph showing the relationship between time and temperature for A0 = 600 is shown. For sterilization of medical devices, A0 values ​​comprised between 600 and 3000 may be used: however, lower or higher A0 values ​​may be set as desired.

[0275] In which the water temperature is constant throughout the disinfection process (“T constant ”), the disinfection dosage A0 can be calculated by the following formula:

[0276]

[0277] Wherein, "A0" is the value of "A" when z = 10°C; t proc is the duration of the disinfection process;

[0278] T constantis the fluid temperature in °C maintained throughout the sterilization process.

[0279] Figure 6 The results of equations 1 and 2 show that the temperature T of the fluid fluid_set The evolution of the time in minutes required to complete the disinfection process, where the disinfection dose A is set 0_set The higher the fluid temperature, the shorter the time required for the sterilization process.

[0280] Based on the above, the thermal disinfection process further includes the following steps: receiving a set disinfection dose A indicating the required disinfection level; 0_set , and the disinfection dose A achieved during the disinfection process 0_achieved In particular, the disinfection process includes the disinfection dose A to be achieved. 0_achieved With the set disinfection dose A 0_set The comparison is made and based on this comparison, if the disinfection dose A achieved 0_achieved Equal to or exceeding the set disinfection dose A 0_set , then stop the disinfection process. Set the disinfection dose A 0_set It can be included between 40 and 2000, in particular between 200 and 1000, more particularly between 500 and 700. It is worth noting that the disinfection dose A achieved 0_achieved The calculation step is based on the reference fluid temperature T measured by at least one temperature sensor 127, 127', 128. ref (i.e., the fluid temperature T in °C measured at time "t" referenced in equations 1 and 2 reported above), where, for safety reasons, the reference fluid temperature T is assumed to be ref Essentially the lowest fluid temperature within the hydraulic circuit 100 during the thermal disinfection process. Figure 1 and Figure 2 The temperature sensor 127' may also be referred to as a low temperature sensor 127', wherein the latter is arranged upstream of the heating unit 104 and close to the inlet of the heating unit 104: therefore, the low temperature sensor 127' is configured to detect the reference fluid temperature T ref Alternatively, when the hydraulic circuit 100 is in the open configuration, the reference fluid temperature T ref It can be measured by a return fluid temperature sensor 128 which is preferably arranged as close as possible to the drain outlet 129 to which the heated fluid flows from the inlet 101 through the dialysis supply line 107 and the dialysis waste line 108 and to.

[0281] Alternatively, according to Figure 5In the circuit, the temperature sensor 323 (also referred to as the low temperature sensor 323) can be arranged upstream of the heating unit 302. On the other hand, the fluid temperature value T fluid_mes The temperature value T of the fluid can be measured by a temperature sensor 127, 303 (also referred to as a high temperature sensor 127, 303) arranged downstream of the heating unit 104, 302; in particular, the high temperature sensor 127, 303 is arranged close to the outlet of the heating unit 104, 302 on the dialysis supply line 107. Therefore, during the disinfection process, the high temperature sensor 127, 303 is configured to detect the fluid temperature value T of the fluid. fluid_mes , and the control unit 500 is configured to control the heating units 104, 302 so that T fluid_mes =T fluid_set In particular, the control unit 500 is configured to control the heating power or energy provided to the fluid by the heating unit 104, 302 during the sterilization process to achieve a desired fluid temperature T fluid_set The heating power is controlled by varying the electrical energy supplied.

[0282] When A corresponding to the disinfection process time period DPt 0_achieved ≥A 0_set The disinfection process is completed when: the disinfection process includes a step of storing the time period DPt relative to the completed disinfection process in a memory (particularly a digital memory). Subsequently, the control unit 500 is configured to determine the start time of the subsequent disinfection process based on the time period DPt of the previous disinfection process. The thermal disinfection process may also include a step of receiving or storing a threshold temperature value TT, so that when the measured temperature of the heated fluid is equal to or exceeds the threshold temperature value TT, the achieved disinfection dose A is calculated. 0_achieved The steps of the sterilization process start: In particular, the measured temperature of the heated fluid is the fluid reference temperature T ref The achieved disinfection dose A is calculated based only on the time period when the measured temperature of the fluid exceeds the threshold temperature TT. 0_achieved On the contrary, during the period of time when the measured temperature of the fluid is below the threshold temperature TT, the achieved disinfection dose A is not calculated. 0_achieved In other words, during the time period in which the measured temperature of the fluid is below the threshold temperature value TT, the disinfection dose A achieved 0_achieved No increase.

[0283] Figure 7An exemplary heating curve of the fluid temperature within the hydraulic circuit 100 as a function of the elapsed time is shown. The C1 curve represents the initial fluid temperature (i.e., 60° C.) before the start of the disinfection process. The heating of the fluid starts at time t0 (corresponding to the time when the control unit 500 activates the heating unit): The C2 curve represents the increase in the fluid temperature over time, which occurs between t0 and t3: In particular, the fluid temperature curve C2 is preferably measured by a low temperature sensor of the hydraulic circuit and is used to calculate the disinfection dose A achieved. 0_achieved It is worth noting that Figure 7 The fact that the fluid temperature of curve C2 in FIG. 1 does not reach a flat constant maximum temperature is not a limitation of the present disclosure: in fact, during the thermal disinfection process, the fluid measured temperature can clearly reach a plateau temperature (level C5) and remain there until the thermal disinfection process is completed. The plateau temperature is the maximum temperature of the fluid at the outlet of the heating unit being controlled and maintained at a maximum fixed temperature T fluid_set caused by the fact.

[0284] Curve C6 represents the threshold temperature value TT: When the fluid temperature curve C2 reaches the threshold temperature value TT at time t1, the disinfection process starts to calculate the achieved disinfection dose A 0_achieved The disinfection dose A is implemented between t1 and t3 0_achieved On the contrary, between t0 and t1, the disinfection dose A achieved is not calculated. 0_achieved Level C5 is the maximum temperature reached by the fluid at the low temperature sensor: in practice, the temperature detected at the high temperature sensor (i.e. at the outlet of the heating unit) may be higher than the temperature represented by curve C2. Curve C3 shows the decrease in the temperature of the fluid that occurs when the thermal disinfection process is terminated (in particular when the control unit 500 deactivates the heating unit).

[0285] The thermal disinfection process of the hydraulic circuit 100 further comprises activating the pumps 120, 122; 450 during the thermal disinfection process to determine the flow of the heating fluid within the hydraulic circuit 100. In order to exclude the dialyzer from the hydraulic circuit to be disinfected, the thermal disinfection process may comprise the step of connecting a shunt tube 132a between the dialysis fluid supply outlet 130 and the dialysate fluid return inlet 133. In addition, at least during the disinfection process, the hydraulic circuit 100 may be configured in a loop for recirculating the heating fluid: according to the aforementioned loop, the loop may comprise the heating unit 104, the pumps 120, 122, at least one temperature sensor 127, 127', 128, at least a portion of the dialysis supply line 107, at least a portion of the dialysis waste line 108, optionally one or more bypass lines 109, 109a fluidly connecting the dialysis supply line 107 with the dialysis waste line 108, and optionally the shunt tube 132a. The disinfection process may mean commanding one or more valves 102, 121, 123, 124, 125, 126 of the dialysis device in an open or closed position to define a loop for recirculating the heating fluid. The term loop refers to the path in which the same heating fluid circulates to perform the disinfection process. In a further embodiment, the control unit 500 may receive a local atmospheric pressure value P atm , and determines which of the different sterilization processes is the most effective sterilization process based on the highest temperature that can be achieved without the fluid boiling into the pipeline. In fact, based on the local atmospheric pressure value P atm and / or the (maximum) set temperature T achievable thereby during the sterilization process fluid_set , the control unit 500 can provide the user with information about the disinfection process that takes the least time to perform (e.g., through a user interface). The user can select the proposed process or reject and continue with a different process.

[0286] Typically, thermal sterilization processes (using the A0 concept in more detail) are preferred. However, based on atmospheric pressure conditions (and based on the desired sterilization level required, e.g., the A0 to be achieved), set target value), the time to obtain thermal disinfection may be too long, and chemical disinfection may be preferred. In other words, using the selected temperature for thermal disinfection, the system can estimate the time required to complete thermal disinfection (based on fluid path design and empirical testing). The estimated time can be used as an indication to the user when thermal disinfection is about to begin. Based on this indication, the user can decide to continue with thermal disinfection or choose another type of disinfection to save time between treatments. In the case of low temperatures, thermal disinfection may take too long to be considered effective, and chemical disinfection (with or without the application of heat) may be a better choice.

[0287] The control unit 500 determines the set temperature T fluid_setCalculate the estimated time T to complete the thermal disinfection process est ; Estimated time to complete the thermal disinfection process T est With reference time T ref A comparison is made; based on the comparison result, the control unit 500 continues the thermal disinfection process or recommends (on the user interface) or starts a different disinfection process, such as a chemical disinfection process. In particular, the reference time can be the time required for a different (e.g., chemical) disinfection with respect to the thermal disinfection. Therefore, the different disinfection process requires less disinfection time than the thermal disinfection process. In one example, the different disinfection process is a chemical disinfection using a chemical disinfectant (such as NaOCl). Alternatively, another disinfectant, such as citric acid, can be used.

[0288] Furthermore, a different sterilization process may also be based on heating a fluid comprising a chemical agent (ie it is a chemical and thermal sterilization); this is advantageous if the sterilization time is reduced.

[0289] The control unit can also be configured so that different disinfection processes can be started automatically.

[0290] It is worth noting that the steps of the previously described thermal disinfection process can be performed by the control unit 500 of the blood treatment device 10 or the water purification device 300 or the peritoneal dialysis machine. Alternatively, the control unit can be remotely arranged (such as a remote server) and configured to receive input data from the sensor through a wired or wireless transmitter and provide command signals to perform the process steps.

Claims

1. A thermal disinfection system (1), comprising a blood treatment device (10), the blood treatment device (10) comprising a hydraulic circuit (100) for fluid transport, the hydraulic circuit (100) having: - at least one dialysis supply line (107) extending from the fluid inlet (101) to a dialysis fluid supply outlet (130) connectable to an inlet of a dialyzer (150); - a dialysis waste line (108) extending from a dialysate fluid return inlet (133) to a drain outlet (129), the dialysate fluid return inlet (133) being configured to be connected to an outlet of the dialyzer (150); - a heating unit (104) configured to heat the fluid in the hydraulic circuit (100); - at least one temperature sensor (127, 127', 128) configured to provide a signal representing the temperature of the fluid in the hydraulic circuit (100) and comprising a high temperature sensor (127) arranged downstream of the heating unit (104) on the dialysis supply line (107) and close to the outlet of the heating unit (104), wherein The high temperature sensor (127) is configured to detect a fluid temperature value T fluid_mes ; - at least one pressure sensor (162) configured to provide a signal representative of the local atmospheric pressure; The blood treatment device (10) comprises a control unit (500) configured to perform a thermal disinfection process of the hydraulic circuit (100), the thermal disinfection process comprising at least the following steps performed by the control unit (500): - receiving a temperature signal from the at least one temperature sensor (127, 127', 128) and determining a measured temperature value T of the fluid within the hydraulic circuit (100) fluid_mes ; - receiving a pressure signal from the at least one pressure sensor (162) and determining a measured local atmospheric pressure value P atm ; -Based on the local atmospheric pressure value P atm Determine the set temperature T of the fluid fluid_set , the set temperature T fluid_set is included between 50°C and 105°C; - Based on the measured temperature value T fluid_mes Control the heating unit (104) to heat the fluid to a set temperature T fluid_set And does not exceed the set temperature T fluid_set , thereby preventing the fluid in the hydraulic circuit (100) from boiling, the control unit (500) is configured to control the heating unit (104) so ​​that the fluid temperature value T fluid_mes Equal to the set temperature T fluid_set .

2. Thermal disinfection system (1) according to the preceding claim 1, wherein: The control unit (500) is configured to determine the local atmospheric pressure value P atm Maximize the set temperature T of the fluid fluid_set , thereby preventing the fluid in the hydraulic circuit (100) from boiling.

3. The thermal disinfection system (1) according to any one of the preceding claims 1 and 2, wherein: The control unit (500) is further configured to: - Receive a set disinfection dose A indicating the desired disinfection level 0_set ; - Calculate the disinfection dose A achieved during the disinfection process 0_achieved , The disinfection process also includes the disinfection dose A to be achieved. 0_achieved With the set disinfection dose A 0_set The comparison is made, and based on the comparison, if the disinfection dose A achieved 0_achieved Equal to or exceeding the set disinfection dose A 0_set , the disinfection process is stopped. Set disinfection dose A 0_set Between 200 and 1000 included, in particular between 500 and 1000 included.

4. The thermal disinfection system (1) according to any one of the preceding claims 1 to 3, wherein: Local atmospheric pressure value P atm Through a predetermined relationship with the set temperature T of the fluid fluid_set The predetermined relationship defines the boiling point temperature BPT as the local atmospheric pressure value P atm The function of Among them, 0.9·BPT <T fluid_set <0.99·BPT, especially 0.9·BPT <T fluid_set <0.97·BPT.

5. The thermal disinfection system (1) according to any one of the preceding claims 1 to 3, wherein: The control unit (500) is configured to: - continuously, periodically or randomly updating the local atmospheric pressure P during the thermal disinfection process according to a predetermined sampling rate atm The sampling rate is comprised between 0.1 Hz and 500 Hz, and the control unit is further configured to update the local atmospheric pressure P based on the updated atm The measurement of T is used to update the set temperature during the sterilization process. fluid_set ;or - At the beginning of the sterilization process or just before the start of the thermal sterilization process, the local atmospheric pressure P is measured by means of a pressure sensor (162) atm , the set temperature of the fluid T fluid_set At the beginning of the thermal disinfection process, the measured local atmospheric pressure P atm Setting, set temperature T of fluid fluid_set Remains constant during the thermal disinfection process.

6. The thermal disinfection system (1) according to any one of the preceding claims 1 to 3, wherein: Achieved disinfection dose A 0_achieved The calculation step is based on the reference fluid temperature T measured by the at least one temperature sensor (127, 127', 128). ref , where the reference fluid temperature is assumed to be T ref is the minimum fluid temperature within the hydraulic circuit (100) during the thermal disinfection process, Among them, the disinfection dose A achieved 0_achieved The number of computation steps is a function of the elapsed time.

7. The thermal disinfection system (1) according to any one of the preceding claims 1 to 3, wherein: Achieved disinfection dose A 0_achieved The calculation step is based on a predetermined z value, which defines the relationship between the temperature of the fluid and the effectiveness of the disinfection process, the z value being comprised between 5° C. and 30° C., Wherein the z value corresponds to the increase in fluid temperature required to reduce the D value of the microorganism by about 90%, where the D value is the time required to kill about 90% of the corresponding microbial population at a given temperature.

8. The thermal disinfection system (1) according to any one of the preceding claims 1 to 3, wherein: Achieved disinfection dose A 0_achieved Calculated by the following disinfection dosage formula: A 0_achieved =∑10 (T(t)-80) / z ·Δt wherein z=10° C., Δt is the time interval in seconds between measurements of the at least one temperature sensor (127, 127′, 128) controlled by the control unit (500), and T=T ref is the reference fluid temperature measured by the at least one temperature sensor (127, 127', 128) during a time interval Δt.

9. The thermal disinfection system (1) according to any one of the preceding claims 1 to 3, wherein: The hydraulic circuit (100) comprises at least one pump (120, 122) and a shunt (132a) connecting a dialysate fluid supply outlet (130) with a dialysate fluid return inlet (133) to bypass the dialyzer (150), and the control unit (500) is configured to activate the at least one pump (120, 122) during a thermal disinfection process to determine the flow of heated fluid within the hydraulic circuit (100).

10. Thermal disinfection system (1) according to the preceding claim 9, wherein: The hydraulic circuit (100) can be configured in a loop for recirculating a heating fluid at least during a disinfection process, the loop comprising at least a heating unit (104), the at least one pump (120, 122), the at least one temperature sensor (127, 127', 128), at least a portion of a dialysis supply line (107), at least a portion of a dialysis waste line (108), one or more valves (102, 121, 123, 124, 125, 126), one or more bypass lines (109, 109a), the one or more One or more valves (102, 121, 123, 124, 125, 126) can be commanded between an open position and a closed position by a control unit (500) to allow or prevent fluid passage, respectively. The one or more bypass lines (109, 109a) fluidly connect the dialysis supply line (107) with the dialysis waste line (108), and the control unit (500) is also configured to command the one or more valves (102, 121, 123, 124, 125, 126) to define the loop for recirculating the heating fluid.

11. The thermal disinfection system (1) according to any one of the preceding claims 1 to 3, wherein: The hydraulic circuit (100) comprises: - a low temperature sensor (127') of the at least one temperature sensor (127, 127', 128) is arranged upstream of the heating unit (104), the low temperature sensor (127') being arranged close to the inlet of the heating unit (104) on the dialysis supply line (107), the fluid temperature measured by the low temperature sensor (127') being assumed to be substantially the lowest fluid temperature within the hydraulic circuit (100), wherein if the fluid flows within the loop, the fluid temperature measured by the low temperature sensor (127') is the reference temperature T of the disinfection dosage formula ref ; and / or - a return fluid temperature sensor (128) of the at least one temperature sensor (127, 127', 128) is arranged on the dialysis waste line (108), the return fluid temperature sensor (128) being arranged as close as possible to the discharge outlet (129), downstream of a return fluid pump (122) arranged on the dialysis waste line (108), wherein when the hydraulic circuit (100) is in an open configuration, the fluid temperature measured by the return fluid temperature sensor (128) is a reference temperature T for the disinfection dosage formula ref , wherein a heating fluid flows from an inlet (101) through a dialysis supply line (107) and a dialysis waste line (108) and flows to a discharge outlet (129).

12. The thermal disinfection system (1) according to any one of the preceding claims 1 to 3, wherein: When A corresponding to the disinfection process time period DPt 0_achieved ≥A 0_set When the disinfection process is completed, the control unit (500) is also configured to store the time period DPt relative to the disinfection process in a memory, wherein the control unit (500) determines the start time of a subsequent disinfection process based on the time period DPt of the previous disinfection process.

13. The thermal disinfection system (1) according to any one of the preceding claims 1 to 3, wherein: The control unit (500) is configured to receive or store a threshold temperature value TT, wherein when the measured temperature of the heating fluid is equal to or exceeds the threshold temperature value TT, the achieved disinfection dose A is calculated. 0_achieved At the beginning of the sterilization process step, the measured temperature of the heated fluid is the fluid reference temperature T ref , Achieved disinfection dose A 0_achieved Calculated only based on the time period when said fluid measured temperature of the fluid exceeds said threshold temperature value TT.

14. A thermal disinfection system (1) comprising a water purification device (300), the water purification device (300) comprising a hydraulic circuit connectable to a disposable device (40) of a peritoneal dialysis device, the hydraulic circuit comprising: - an inlet port (399) for receiving water from a water source (398); - a reverse osmosis (RO) module (170) configured to remove at least one of microorganisms, pyrogens and ionic substances from water by reverse osmosis; - a filtration unit comprising one or more water filters (160, 170, 180) configured to remove impurities from the water at least during a treatment procedure performed by the peritoneal dialysis device; - a heating unit (302) configured to heat the fluid in the hydraulic circuit (100); - a pump (450); - at least one temperature sensor (303, 313, 323) configured to provide a signal representative of the temperature of the fluid; - at least one pressure sensor (362) configured to provide a signal representative of local atmospheric pressure; The water purification device (300) comprises a control unit (500), the control unit (500) being configured to perform a thermal disinfection process of a hydraulic circuit of the water purification device (300), the thermal disinfection process comprising at least the following steps performed by the control unit (500): - activating the pump (450) at least during the thermal disinfection process to ensure the flow of heated water in the hydraulic circuit; - receiving a temperature signal from the at least one temperature sensor (303, 313, 323) and determining a measured temperature value T of the water in the hydraulic circuit fluid_mes ; - receiving a pressure signal from the at least one pressure sensor (362) and determining a measured local atmospheric pressure value P atm ; - Based on the measured temperature value T fluid_mes and the measured local atmospheric pressure value P atm To drive the heating unit (302) to heat the fluid.

15. The thermal disinfection system (1) according to claim 14, wherein: The hydraulic circuit (100) comprises: The low temperature sensor (127'; 323) of the at least one temperature sensor (127, 127', 128; 303, 313, 323) is arranged upstream of the heating unit (104) and close to the inlet of the heating unit (104; 302). Assuming that the fluid temperature measured by the low temperature sensor (127'; 323) is the lowest fluid temperature in the hydraulic circuit (100), the fluid temperature measured by the low temperature sensor (127'; 323) is the reference temperature T of the disinfection dosage formula. ref ;as well as The high temperature sensor (127; 303) of the at least one temperature sensor (127, 127', 128; 303, 313, 323) is arranged downstream of the heating unit (104; 302) and close to the outlet of the heating unit (104; 302), wherein the high temperature sensor (127; 303) is configured to detect the fluid temperature value T of the fluid fluid_mes , the control unit (500) is configured to control the heating unit (104; 302) so that T fluid_mes =T fluid_set .

16. Thermal disinfection system (1) according to any one of the preceding claims 14 to 15, wherein: The hydraulic circuit (100) of the water purification device (300) comprises: a pretreatment module (160) having a particle filter configured to remove particles and an activated carbon bed configured to remove at least one of hypochlorite, chloramines and chlorine, wherein a reverse osmosis (RO) module (170) is arranged downstream of the pretreatment module (160); and A post-treatment module (180) configured to remove ions from incoming water, wherein the post-treatment module (180) comprises an electrodeionization device (EDI).

17. Thermal disinfection system (1) according to any one of the preceding claims 14 to 15, wherein: The thermal disinfection process comprises the following steps executed by the control unit (500): based on the measured temperature value T of the fluid in the hydraulic circuit (100); fluid_mes and the measured local atmospheric pressure value P atm Either or both of the above, determine the disinfection process to be applied from multiple available disinfection processes.

18. A thermal disinfection system (1), comprising a peritoneal dialysis device, the peritoneal dialysis device comprising a hydraulic circuit (100) for fluid transport, the hydraulic circuit (100) having: - at least one dialysis fluid supply line, extending from a dialysis fluid inlet to a dialysis fluid supply outlet, configured to directly or indirectly transfer fresh peritoneal dialysis fluid to a catheter of the patient; - a dialysis waste line extending from a spent peritoneal dialysis fluid inlet to a drain outlet, the spent peritoneal dialysis fluid inlet (133) being configured to receive spent peritoneal dialysis fluid directly or indirectly from a catheter of a patient; - a heating unit (104) configured to heat the fluid in the hydraulic circuit (100); - at least one temperature sensor (127, 127', 128) configured to provide a signal representative of the temperature of the fluid in the hydraulic circuit (100); - at least one pressure sensor (162) configured to provide a signal representative of the local atmospheric pressure; The peritoneal dialysis treatment device (10) comprises a control unit (500), the control unit (500) being configured to perform a thermal disinfection process of the hydraulic circuit (100), the thermal disinfection process comprising at least the following steps performed by the control unit (500): - receiving a temperature signal from the at least one temperature sensor (127, 127', 128) and determining a measured temperature value T of the fluid within the hydraulic circuit (100) fluid_mes ; - receiving a pressure signal from the at least one pressure sensor (162) and determining a measured local atmospheric pressure value P atm ; -Based on the local atmospheric pressure value P atm Determine the set temperature T of the fluid fluid_set To avoid boiling of the fluid in the hydraulic circuit (100), the set temperature T fluid_set is included between 70°C and 105°C; - Driving the heating unit (104) to heat the fluid to a set temperature T fluid_set .

19. The thermal disinfection system (1) according to claim 18, wherein: The thermal disinfection process comprises at least the following steps performed by the control unit (500): - Receive a set disinfection dose A indicating the desired disinfection level 0_set ; - receiving a threshold temperature value TT; - Calculate the disinfection dose A achieved during the disinfection process 0_achieved , wherein the disinfection dose A achieved is calculated 0_achieved is based on the elapsed time Δt and a reference fluid temperature T measured by the at least one temperature sensor (127, 127', 128; 303, 313, 323) ref , reference fluid temperature T ref is the lowest fluid temperature in the hydraulic circuit (100) during the thermal disinfection process, wherein when the reference temperature T of the heated fluid is ref When the temperature is equal to or exceeds the threshold value TT, the disinfection dose A is calculated. 0_achieved The steps start; - The disinfection dose A to be achieved 0_achieved With the set disinfection dose A 0_set The comparison is made, and based on the comparison, if the disinfection dose A achieved 0_achieved Equal to or exceeding the set disinfection dose A 0_set , the disinfection process is stopped.

20. The thermal disinfection system (1) according to claim 19, wherein: Local atmospheric pressure value P atm Through a predetermined relationship with the set temperature T of the fluid fluid_set The predetermined relationship defines the boiling point temperature BPT as the local atmospheric pressure value P atm The function of Among them, 0.9·BPT <T fluid_set <0.99·BPT, especially 0.9·BPT <T fluid_set <0.96·BPT.

21. The thermal disinfection system (1) according to claim 19 or 20, wherein: Achieved disinfection dose A 0_achieved Calculated only based on the time period when said fluid measured temperature of the fluid exceeds said threshold temperature value TT.

22. The thermal disinfection system (1) according to claim 18 or 19, wherein: The control unit (500) is configured to continuously update the local atmospheric pressure P during the thermal disinfection process according to a predetermined sampling rate during the entire time period of the disinfection process. atm For measurements, the sampling rate is included between 0.01 Hz and 1000 Hz.

23. The thermal disinfection system (1) according to claim 22, wherein: The control unit is configured to update the local atmospheric pressure P based on the atm The measurement of T is used to update the set temperature during the sterilization process. fluid_set .

24. The thermal disinfection system (1) according to claim 18 or 19, wherein: The hydraulic circuit (100) comprises: The low temperature sensor (127'; 323) of the at least one temperature sensor (127, 127', 128; 303, 313, 323) is arranged upstream of the heating unit (104) and close to the inlet of the heating unit (104; 302), assuming that the low temperature sensor (127'; 323) The measured fluid temperature is the lowest fluid temperature in the hydraulic circuit (100), and the fluid temperature measured by the low temperature sensor (127'; 323) is the reference temperature T of the disinfection dosage formula. ref ;as well as The high temperature sensor (127; 303) of the at least one temperature sensor (127, 127', 128; 303, 313, 323) is arranged downstream of the heating unit (104; 302) and close to the outlet of the heating unit (104; 302), wherein the high temperature sensor (127; 303) is configured to detect the fluid temperature value T of the fluid fluid_mes , the control unit (500) is configured to control the heating unit (104; 302) so that T fluid_mes =T fluid_set .

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