Thermal Disinfection System for Medical Devices

Abstract

A thermal disinfection system and method for performing a thermal disinfection procedure on fluid lines of a medical device, the thermal disinfection procedure comprising at least the steps of receiving a temperature signal from a temperature sensor and measuring a measured temperature value T of a fluid in the fluid circuit. fluid_mes receiving a pressure signal from the pressure sensor; and determining a measured local air pressure value P atm and determining the measured temperature value T fluid_mes and the measured local pressure value P atm and driving the heating unit to heat the liquid based on the

Description

[Technical field]

[0001] The present invention relates to a disinfection system capable of performing a thermal disinfection procedure in a medical device, such as a blood treatment device, or for a water purification device connectable to a medical device.Furthermore, the present invention relates to a disinfection system capable of performing a thermal disinfection procedure in a peritoneal dialysis device.

[0002] The present invention also relates to a method for performing a thermal disinfection procedure on a medical device. [Background technology]

[0003] There are several types of procedures in which blood is extracted in an extracorporeal blood circuit, including, for example, hemodialysis, hemofiltration, hemodiafiltration, plasma exchange, blood component separation, blood oxygenation, etc. Typically, blood is removed from a blood vessel at an access site and returned to the same vessel or to another location within the body.

[0004] The process fluid (also called dialysate) and the patient's blood are made to flow on either side of a semipermeable membrane of a membrane device (typically called a dialyzer). Diffusional transport from one side of the membrane to the other is achieved when the concentrations of substances on either side of the membrane are different. Such substances may be impurities in the blood (urea, creatinine, etc.), which thereby move from the blood to the process fluid. In a process by hemodiafiltration, the diffusional transport is supplemented by convective transport due to ultrafiltration, which is caused by a pressure difference created between the blood side and the process fluid side of the membrane.

[0005] An apparatus for extracorporeal blood treatment may include a dialysis machine connected to a disposable extracorporeal blood circuit that includes blood transport lines (typically an arterial line for removing blood from the patient and a venous line for returning blood to the patient) and a membrane device for blood treatment.

[0006] The semi-permeable membrane of the membrane device separates the blood compartment, which is connected to a blood transport line, from a liquid compartment, which is connected to a process liquid supply and drain circuit. The blood transport line may further be coupled to a sensor and actuator system equipped in the dialysis machine, which typically includes a means for blood circulation, a pressure sensor, an air bubble sensor, one or more circuit blocking clamps, a blood detector, etc.

[0007] The process fluid supply circuit receives purified water from a water supply system, which may be a small unit providing water to only a single process control machine, or a larger unit providing water to multiple process units, for example in a hospital or clinic, in a water system loop configuration.

[0008] Dialysis fluid that may come into contact with the patient's blood is often prepared from purified water through 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 decomposition products, such as endotoxins. Therefore, the treatment fluid path of the dialysis machine may be disinfected between dialysis treatments to reduce the presence of viruses, fungi, bacteria, etc. in the treatment fluid path. Although chemical disinfection (e.g., using NaOCl or other chemical disinfectants) is an efficient method to reduce the presence of bacteria, etc., it brings about a large demand for subsequent rinsing procedures and requires very close measurements to ensure that the treatment fluid path is free of chemical residual products for safety reasons before it is used for subsequent treatments. Chemical processes are also not environmentally friendly and may have a negative impact on the lifespan of disinfected parts and components.

[0009] In an alternative disinfection process, thermal disinfection is achieved by introducing hot water into the processing fluid path. As a result, there is no problem with residual chemical products, the process is environmentally friendly, and in many cases has relatively little adverse effect on the life of disinfected parts and components compared to the use of biologically aggressive solutions (e.g., chlorine).

[0010] In a further alternative disinfection process, thermal disinfection is combined with chemical agents such as citric acid to achieve efficient disinfection of the treatment fluid pathway. WO 96 / 09080 discloses a disinfection arrangement for a dialysis machine consisting of a clean side and a dirty side. The clean side comprises an inlet for water, a heat exchanger and a water container containing a heater. A supply conduit leads from the water container to a tube that is normally 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 circuit. A second recirculation circuit is constituted by a recirculation conduit, a valve, a tube that is normally connected to the dirty side of the dialyzer, a return conduit and a pump. The heat exchanger heats the liquid in the second circuit with the help of the liquid in the first circuit, which is heated by the heater in the water container. A small amount of liquid is transported from the first circuit to the second circuit via a shunt conduit.

[0011] Thermal disinfection of the processing fluid pathways of the machine is preferably performed after each patient treatment. As the number of dialysis patients increases, there is a need to increase the time available for treatment in clinics. It is therefore desirable to reduce the time spent on disinfection between treatments.

[0012] An increase in the liquid temperature leads to a decrease in the time required for the disinfection process to be carried out; in any case, excessive temperatures may lead to liquid boiling which leads to the growth of gas bubbles in the circuit, thus reducing the effectiveness of the disinfection process and determining damage to the liquid lines. On the other hand, a reduction in the liquid temperature to prevent boiling will correspondingly increase the time required for the circuit disinfection.

[0013] CN 106110350 discloses a hemodialysis machine with a sterilization unit. The disinfectant boiling point T1 depends on the ambient pressure, and boiling liquid may prevent effective sterilization from occurring. The proposed sterilization solution according to CN 106110350 includes two similar embodiments. In one first case, the disinfection device calculates the disinfectant solution boiling point T1 based on the measured air pressure value, the disinfection device sets the temperature of the disinfectant solution to T2 slightly lower than the boiling point T1, the line end temperature T3 is measured, and the device determines the disinfection concentration N1 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 liquid concentration N1, where M=pT3+qN1, where "p" is the temperature coefficient and "q" is the concentration coefficient.

[0014] WO 2014 / 082855 deals with hot water disinfection of water systems and dialysis machines using the A0 disinfection concept. The application describes the use of the washer-disinfector disinfection algorithm A0 (in accordance with standard ISO 15883-1:2009) in the water systems / dialysis machines during the disinfection process.

[0015] WO 2018 / 228765 deals with a water purifier that can be cleaned at the point-of-care. The water purifier provides for efficient use of a heater for thermal disinfection, for example by recirculating the heated liquid to further heat the liquid. Several different cleaning programs are provided that may be used to clean different parts of the water purifier. To achieve this, the water purifier performs a thermal disinfection program to prevent bacterial growth in the liquid path. The thermal disinfection is based on the A0 concept, which specifies the amount of thermal disinfection. Summary of the Invention

[0016] <Objective of the Invention> The scope of the present invention is therefore to at least partially address one or more of the disadvantages and / or limitations of the aforementioned solutions.

[0017] The first scope is to provide a thermal disinfection system that can minimize the time required to disinfect a medical device.

[0018] A further scope is to provide a thermal disinfection system that can maximize the effectiveness of the disinfection and at the same time reduce the time required for the disinfection procedure.

[0019] A further scope is to provide a thermal disinfection system which is able to minimize the time required for disinfection and at the same time avoid damage to the fluid circuits of the medical device.

[0020] A further scope is to provide a thermal disinfection system that is a water purification device connectable to a medical device.

[0021] <Summary section> One aspect of the invention relates to a thermal disinfection system (1) comprising a control unit (500) configured to perform a thermal disinfection procedure of a fluid circuit (100) of a medical device, in particular a blood treatment device or a peritoneal dialysis device or a water purification device, said fluid 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), The thermal disinfection procedure comprises at least the following steps, executed by the control unit (500): receiving a temperature signal from said at least one temperature sensor (127, 127', 128, 303, 313, 323) and measuring the measured temperature T of the liquid in said fluid circuit (100); fluid_mes and determining receiving a pressure signal from said at least one pressure sensor (162, 362) and measuring the local air pressure value P atm and determining - the measured temperature value T fluid_mes and the measured local pressure value P atm and driving the at least one heating unit (104, 302) to heat the liquid based on

[0022] Another independent aspect of the invention relates to a thermal disinfection system (1) comprising a control unit (500) configured to perform a thermal disinfection procedure of a fluid circuit (100) of a medical device, in particular a blood treatment device or a peritoneal dialysis device or a water purification device, said fluid 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), The thermal disinfection procedure comprises at least the following steps, executed by the control unit (500): receiving a temperature signal from said at least one temperature sensor (127, 127', 128, 303, 313, 323) and determining a measured temperature value T of the liquid in said fluid circuit (100); fluid_mes and determining receiving a pressure signal from said at least one pressure sensor (162, 362) and measuring the local air pressure value P atm and determining - the measured local pressure value P atm and the measured temperature value T of the liquid in the fluid circuit (100). fluid_mes and determining an applicable sterilization treatment from among a plurality (at least two) available sterilization treatments based on either or both of the above.

[0023] In a further aspect according to the preceding aspect, determining the disinfection treatment to be applied comprises: - the measured local pressure value P atm and the measured temperature value T of the liquid in the fluid circuit (100). fluid_mes Based on either or both of the above, an estimated time to completion of the thermal disinfection procedure (T est ) and - the estimated time to completion of the thermal disinfection procedure (T est ) to the reference time (T ref ) and - Based on the comparison result, continuing the thermal disinfection treatment or recommending / initiating a different disinfection treatment, e.g. a chemical disinfection treatment.

[0024] In a further aspect according to the preceding aspect, the different disinfection treatment requires less time to disinfect than the thermal disinfection treatment.

[0025] The first aspect relates to a thermal disinfection system (1) including a blood treatment device (10) with a fluid circuit (100) for liquid transport, said fluid circuit (100) comprising: 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 dialysate discharge line (108) extending from a dialysate return inlet (133) to a drain outlet (129), said dialysate return inlet (133) being adapted to connect to an outlet of said dialyzer (150); a heating unit (104) configured to heat a liquid in said fluid circuit (100), in particular water or a disinfecting solution or a dialysis solution or a mixture thereof; at least one temperature sensor (127, 127', 128) configured to provide a signal representative of the temperature of the liquid in said fluid circuit (100); at least one pressure sensor (162) configured to provide a signal representative of the local air pressure, The blood treatment device (10) comprises a control unit (500) configured to perform a thermal disinfection treatment of the fluid circuit (100), the thermal disinfection treatment comprising at least the following steps executed by the control unit (500): receiving the temperature signal from the at least one temperature sensor (127, 127', 128) and determining a measured temperature value T of the liquid in the fluid circuit (100); fluid_mes and determining receiving said pressure signal from said at least one pressure sensor (162) and determining a measured local air pressure value P atm and determining - the measured temperature value T fluid_mes and the measured local pressure value P atmand driving the heating unit (104) to heat the liquid based on the

[0026] A second aspect relates to a thermal disinfection system (1) including a water purification device (300) with a fluid circuit connectable to a disposable set (40) of a peritoneal dialysis machine, said fluid circuit comprising: - an inlet port (399) for receiving water from a water source (398); a filtration unit comprising one or more water filters (160, 170, 180) configured to remove impurities from said water at least during a treatment session carried out by said peritoneal dialysis machine; a heating unit (302) configured to heat the liquid in said fluid circuit (100); at least one temperature sensor (303, 313, 323) configured to provide a signal representative of the liquid temperature; at least one pressure sensor (362) configured to provide a signal representative of the local air pressure, The water purification device (300) comprises a control unit (500) configured to perform a thermal disinfection treatment of the fluid circuit of the water purification device (300), the thermal disinfection treatment comprising at least the following steps executed by the control unit (500): receiving the temperature signal from the at least one temperature sensor (303, 313, 323) and determining a measured temperature value T of the water in the fluid circuit; fluid_mes and determining - receiving said pressure signal from at least one pressure sensor (362) and measuring the local pressure value P atm and determining - the measured temperature value T fluid_mes and the measured local pressure value P atm and driving the heating unit (302) to heat the liquid based on the

[0027] A third aspect relates to a thermal disinfection system (1) including a peritoneal dialysis device with a fluid circuit (100) for transporting a liquid, the fluid circuit (100) comprising: at least one dialysate supply line extending from a dialysate inlet to a dialysate supply outlet configured to transport fresh peritoneal dialysate directly or indirectly to a patient's catheter; - optionally a dialysis drain line extending from a spent peritoneal dialysis fluid inlet to a drain outlet, said spent peritoneal dialysis fluid inlet (133) configured to receive spent peritoneal dialysis fluid directly or indirectly from the patient's catheter; a heating unit configured to heat the liquid in said fluid circuit (100); at least one temperature sensor configured to provide a signal representative of the temperature of the liquid in said fluid circuit (100); at least one pressure sensor (162) configured to provide a signal representative of the local air pressure, The peritoneal dialysis treatment device comprises a control unit (500) configured to perform a thermal disinfection treatment of the fluid circuit (100), the thermal disinfection treatment comprising at least the following steps executed by the control unit (500): receiving the temperature signal from the at least one temperature sensor and determining a measured temperature value T of the liquid in the fluid circuit (100); fluid_mes and determining receiving said pressure signal from said at least one pressure sensor (162) and determining a measured local air pressure value P atm and determining - the measured temperature value T fluid_mes and the measured local pressure value P atm and driving the heating unit (104) to heat the liquid based on the

[0028] A fourth aspect relates to a method for thermal disinfection of a medical device, in particular a blood treatment device (10) or a peritoneal dialysis device or a water purification device (300) optionally connectable to a peritoneal dialysis device according to any one of the preceding aspects, said medical device comprising a fluid circuit (100), The method comprises at least the following steps: receiving a temperature signal from at least one temperature sensor (127, 127', 128, 303, 313, 323) and determining a measured temperature value T of a liquid in said fluid circuit (100); fluid_mes and determining - receiving a pressure signal from at least one pressure sensor (162) and measuring the local air pressure value P atm and determining - the measured temperature value T fluid_mes and the measured local pressure value P atm and driving a heating unit (104, 302) to heat the liquid based on the

[0029] A fifth aspect relates to a method of thermal disinfection for a blood processing device (10) comprising a fluid circuit (100) for transporting liquids, said fluid circuit (100) comprising: 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 dialysate discharge line (108) extending from a dialysate return inlet (133) to a drain outlet (129), said dialysate return inlet (133) being adapted to connect to an outlet of said dialyzer (150); a heating unit (104) configured to heat a liquid in said fluid circuit (100), in particular water or a disinfecting solution or a dialysis solution or a mixture thereof; at least one temperature sensor (127, 127', 128) configured to provide a signal representative of the temperature of the liquid in said fluid circuit (100); at least one pressure sensor (162) configured to provide a signal representative of the local air pressure, The method includes a thermal disinfection treatment of the fluid circuit (100), the thermal disinfection treatment comprising at least the following steps: - receiving the temperature signal from the at least one temperature sensor (127, 127', 128) and determining a measured temperature value (T fluid_mes ) and - receiving said pressure signal from said at least one pressure sensor (162) and determining a measured local air pressure value (P atm ) and - the measured temperature value (T fluid_mes ) and the measured local pressure value (P atm and driving the heating unit (104) to heat the liquid based on the temperature of the liquid.

[0030] Another independent aspect relates to a thermal disinfection system (1) including a blood treatment device (10) having a fluid circuit (100) for liquid transport, said fluid circuit (100) comprising: 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 dialysate discharge line (108) extending from a dialysate return inlet (133) to a drain outlet (129), said dialysate return inlet (133) being adapted to connect to an outlet of said dialyzer (150); a heating unit (104) configured to heat a liquid in said fluid circuit (100), in particular water or a disinfecting solution or a dialysis solution or a mixture thereof; at least one temperature sensor (127, 127', 128) configured to provide a signal representative of the temperature of the liquid in said fluid circuit (100); at least one pressure sensor (162) configured to provide a signal representative of the local air pressure, The blood treatment device (10) comprises a control unit (500) configured to perform a thermal disinfection treatment of the fluid circuit (100), the thermal disinfection treatment comprising at least the following steps executed by the control unit (500): - receiving the temperature signal from the at least one temperature sensor (127, 127', 128) and determining a measured temperature value (T fluid_mes ) and - receiving said pressure signal from said at least one pressure sensor (162) and determining a measured local air pressure value (Patm ) and the local air pressure value (P atm ) based on the set temperature (T fluid_set ) and determining the set temperature (T fluid_set ) is between 70°C and 105°C; - the determined set temperature (T fluid_set ) based on the estimated time to completion of the thermal disinfection procedure (T est ) and - the estimated time to completion of the thermal disinfection procedure (T est ) to the reference time (T ref ) and - Based on the comparison result, continuing the thermal disinfection treatment or recommending / initiating a different disinfection treatment, e.g. a chemical disinfection treatment.

[0031] In a further aspect according to the preceding aspect, the different disinfection treatment requires less time to disinfect than a thermal disinfection treatment, and in particular, the different disinfection treatment is a chemical disinfection using a chemical disinfectant such as NaOCl, although alternatively, another disinfectant such as citric acid may be used.

[0032] Furthermore, the different disinfection procedures may also be based on heating a liquid containing a chemical agent (i.e. this is chemical and thermal disinfection).

[0033] In a further aspect according to the preceding two aspects, the control unit (500) is configured to provide an indication on a user interface of the blood processing device (10) that the different sterilization procedure is recommended and to allow a user to accept or reject the different sterilization procedure.

[0034] Alternatively, the different disinfection procedures may commence automatically.

[0035] In another independent aspect, a thermal disinfection system (1) including a blood treatment device (10) having a fluid circuit (100) for liquid transport, said fluid circuit (100) comprising: 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 dialysate discharge line (108) extending from a dialysate return inlet (133) to a drain outlet (129), said dialysate return inlet (133) being adapted to connect to an outlet of said dialyzer (150); a heating unit (104) configured to heat a liquid in said fluid circuit (100), in particular water or a disinfecting solution or a dialysis solution or a mixture thereof; at least one temperature sensor (127, 127', 128) configured to provide a signal representative of the temperature of the liquid in said fluid circuit (100); at least one pressure sensor (162) configured to provide a signal representative of the local air pressure, The blood treatment device (10) comprises a control unit (500) configured to perform a thermal disinfection treatment of the fluid circuit (100), the thermal disinfection treatment comprising at least the following steps executed by the control unit (500): - receiving the temperature signal from the at least one temperature sensor (127, 127', 128) and determining a measured temperature value (T fluid_mes ) and - receiving said pressure signal from said at least one pressure sensor (162) and determining a measured local air pressure value (P atm ) and the local air pressure value P in order to avoid boiling of the liquid in the fluid circuit (100); atm Based on the set temperature of the liquid (T fluid_set ) and determining the set temperature (T fluid_set ) is between 70°C and 105°C; - The liquid is heated to the set temperature (T fluid_setdriving the heating unit (104) to heat to - receiving a set disinfection amount (A 0_set ) representing the required disinfection level - receiving a threshold temperature value (TT) - calculating an achieved disinfection amount (A 0_achieved ) during the disinfection treatment, where calculating the achieved disinfection amount (A 0_achieved ) is based on the elapsed time (ΔT) and the reference liquid temperature (T ref ) measured by the at least one temperature sensor (127, 127´, 128, 303, 313, 323), and the reference liquid temperature (T ref ) is the substantially lowest liquid temperature in the fluid circuit (100) during the heat disinfection treatment, and the step of calculating the achieved disinfection amount (A 0_achieved ) starts when the reference temperature (T ref ) of the heated liquid is equal to or higher than the threshold temperature (TT), - comparing the achieved disinfection amount (A 0_achieved ) with the set disinfection amount (A 0_set ) and interrupting the disinfection treatment if the achieved disinfection amount (A 0_achieved ) is equal to or higher than the set disinfection amount (A 0_set ), a heat disinfection system (1).

[0036] In a further aspect according to the preceding aspect, the local atmospheric pressure value (P atm ) is related to the liquid set temperature (T fluid_set ) by a predetermined relationship, and the predetermined relationship defines a boiling point temperature BPT as a function of the local atmospheric pressure value (P atm ), 0.9·BPT < T fluid_set < BPT, in particular 0.9·BPT < T fluid_set < 0.99·BPT, and more particularly 0.9·BPT < T fluid_set < 0.96·BPT.

[0037] In a further aspect according to the preceding two aspects, the achieved disinfection amount (A 0_achieved) is calculated based solely on the duration that the measured liquid temperature of the liquid exceeds the threshold temperature (TT).

[0038] In a further aspect according to the preceding three aspects, the control unit (500) controls the local air pressure (P atm ) continuously, in particular during the entire duration of the disinfection procedure, according to a predefined sample rate, said sample rate being comprised between 0.01 Hz and 1000 Hz, in particular between 0.1 Hz and 500 Hz.

[0039] In a further aspect according to the preceding aspect, the control unit is adapted to control the local air pressure (P atm ) during the disinfection procedure based on the updated measurements of the set temperature (T fluid_set ) is configured to update the

[0040] In a sixth aspect according to any one of the preceding aspects, the control unit (500) fluid_mes and the measured local pressure value P atm When the heating unit (104) is driven to heat the liquid based on - the local pressure value P atm Based on the set temperature T of the liquid fluid_set determining the set temperature T fluid_set is optionally comprised between 50°C and 105°C, in particular between 70°C and 100°C; - Said set temperature T fluid_set The measured temperature value T fluid_mes and controlling the heating unit (104, 302) based on the temperature.

[0041] In a seventh aspect according to any one of the preceding aspects, the control unit (500) - Set disinfection amount A, which represents the required disinfection level 0_setand - During the disinfection procedure, the disinfection amount achieved A 0_achieved and, the method further comprises:

[0042] In an eighth aspect according to any one of the preceding aspects, the disinfection treatment comprises: 0_achieved The set disinfection amount A 0_set and based on said comparison, determining the achieved disinfection amount A 0_achieved is the set disinfection amount A 0_set If so, interrupting the disinfection procedure.

[0043] In a ninth aspect according to any one of the preceding aspects, the set disinfection amount value A 0_set is comprised between 40 and 2000, in particular between 200 and 1000, and more particularly between 500 and 950.

[0044] In a ninth aspect according to any one of the preceding aspects, the set disinfection amount value A 0_set is set to a main level of reception equal to 900, in particular corresponding to temperatures above 80 ° C for 15 minutes, or an auxiliary level of reception downstream of the dialyzer equal to 600, in particular, or a third level of reception equal to 400.

[0045] In a tenth aspect according to any one of the preceding aspects, the control unit (500) is configured to control the local air pressure value P atm Based on the liquid set temperature T fluid_set The method may be configured to maximize or the method may include this step.

[0046] In an eleventh aspect according to any one of the preceding aspects, the local pressure value P atm is set to the liquid set temperature T fluid_set and the predetermined relationship is related to the local pressure value P atm The boiling point temperature BPT is specified as a function of , and in particular, 0.9 BPT <Tfluid_set <It is BPT, and more particularly 0.9·BPT < T fluid_set <It is 0.99·BPT, and more particularly 0.9·BPT < T fluid_set <It is 0.96·BPT.

[0047] <On the 12th side surface by any one of the preceding side surfaces, the control unit (500) continuously, periodically or randomly measures the local air pressure (P atm ) during the heat disinfection treatment, particularly according to a predetermined sample rate throughout the entire period of the disinfection treatment, and the sample rate is included between 0.01 Hz and 1000 Hz, particularly between 0.1 Hz and 500 Hz, or is configured to perform this or the method includes this.

[0048] <On the 13th side surface by any one of the preceding side surfaces, the control unit updates the set temperature T atm during the disinfection treatment based on the updated measured value of the local air pressure P fluid_set and is configured to do so.

[0049] <On the 14th side surface by any one of the 1st to 13th preceding side surfaces, the control unit (500) measures the local air pressure P atm by the pressure sensor (162, 362) at the initial stage of the disinfection treatment or immediately before the start of the heat disinfection treatment, and particularly, the control unit (500) is configured to measure the local air pressure P atm only at the initial stage of the disinfection treatment or the method includes this.

[0050] <On the 15th side surface by the preceding side surface, the liquid set temperature T fluid_set is set at the initial stage of the heat disinfection treatment according to the measured local air pressure value P atm , and the liquid set temperature T fluid_set is kept constant during the heat disinfection treatment.

[0051] In a sixteenth aspect according to any one of the preceding aspects, the achieved disinfection amount A 0_achieved The calculation step of is based on a reference liquid temperature (T ref ), in particular, based on the reference liquid temperature (T ref ) is assumed to be the minimum substantial liquid temperature within the fluid circuit (100) during the thermal disinfection procedure.

[0052] In a seventeenth aspect according to any one of the preceding aspects, the achieved disinfection amount A 0_achieved is a function of elapsed time.

[0053] In an eighteenth aspect according to any one of the preceding aspects, the achieved disinfection amount A 0_achieved is based on a pre-defined z-value defining the relationship between the liquid temperature and disinfection treatment effectiveness, optionally said z-value being between 5°C and 30°C, preferably z-value=10°C, in particular said z-value corresponding to the increase in liquid temperature required to reduce the D-value of a particular microorganism by approximately 90%, said D-value being the time required to kill approximately 90% of a population of individual microorganisms at a given temperature.

[0054] In a nineteenth aspect according to any one of the preceding aspects, the achieved disinfection amount A 0_achieved is the following disinfection amount formula: Calculated by TIFF0007667244000001.tif1486, z=10° C., Δt is the time interval (in seconds) between measurements by the at least one temperature sensor (127, 127′, 128, 303, 313, 323) controlled in particular by the control unit (500), and T=T ref is the reference liquid temperature measured by said at least one temperature sensor (127, 127', 128, 303, 313, 323) within said time interval Δt, of the thermal disinfection system (1).

[0055] In a twentieth aspect according to the preceding aspect, the interval is 0.001 s<Δt<100 s, in particular included in the range 0.05 s<Δt<10 s.

[0056] In a twenty-first aspect according to any one of the preceding aspects, the fluid circuit (100) comprises at least one pump (120, 122, 450), and the control unit (500) is configured to operate the at least one pump (120, 122) to determine the flow of the heated liquid in the fluid circuit (100) during the thermal disinfection procedure.

[0057] In a twenty-second aspect according to any one of the preceding aspects, the fluid circuit includes a shunt (132a) connecting the dialysate supply outlet (130) to the dialysate return inlet (133) to bypass the dialyzer (150).

[0058] In a twenty-third aspect according to any one of the preceding aspects, the fluid circuit (100) is configurable into a loop circuit for recirculation of the heated liquid at least during the sterilization procedure.

[0059] In a twenty-fourth aspect according to the preceding aspect, the loop circuit comprises at least the heating unit (104), the at least one pump (120, 122, 450), the at least one temperature sensor (127, 127', 128, 303, 313, 323), at least a portion of the dialysis supply line (107), at least a portion of the dialysis discharge line (108), optionally a bypass line (109, 109a) fluidly connecting the dialysis supply line (107) to the dialysis discharge line (108), and optionally the shunt tube (132a).

[0060] In a twenty-fifth aspect according to any one of the preceding aspects, the fluid circuit (100) comprises at least one or more valves (102, 121, 123, 124, 125, 126) commandable by the control unit (500) between open and closed positions to respectively enable or prevent the passage of the liquid, and the control unit (500) is further configured to command the one or more valves (102, 121, 123, 124, 125, 126) to define the loop circuit for recirculation of the heated liquid.

[0061] In a twenty-sixth aspect according to any one of the preceding aspects, the fluid circuit (100) further 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) being arranged in particular on the dialysis supply line (107) near the inlet of the heating unit (104), and optionally the liquid temperature measured by the low temperature sensor (127', 323) being assumed to be a substantially minimum liquid temperature in the fluid circuit (100), in particular if the liquid flows in a loop circuit, the liquid temperature measured by the low temperature sensor (127', 323) being less than the reference temperature T ref The low temperature sensor (127', 323) is provided.

[0062] In a twenty-seventh aspect according to any one of the preceding aspects, the fluid circuit (100) further comprises a return fluid temperature sensor (128) disposed on the dialysis discharge line (108) among the at least one temperature sensor (127, 127', 128, optionally disposed as close as possible to the drain outlet (129) downstream of a return fluid pump (122) preferably disposed on the dialysis discharge line (108), the liquid temperature measured by the return fluid temperature sensor (128) being equal to or greater than the reference temperature T ref The return liquid temperature sensor (128) is provided.

[0063] In a twenty-eighth aspect according to any one of the preceding aspects, the fluid circuit (100) further 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) being arranged in particular on the dialysis supply line (107) near the outlet of the heating unit (104, 302), the high temperature sensor (127, 303) detecting the liquid temperature value T fluid_mes The control unit (500) is configured to detect T fluid_mes =T fluid_set and a high temperature sensor (127) configured to control the heating unit (104, 302) so that

[0064] In a twenty-ninth aspect according to any one of the preceding aspects, the control unit (500) is configured to control a desired liquid temperature T fluid_setIn one embodiment, the control unit (500) is configured to control the heating power or energy provided to the liquid by the heating unit (104, 302) to reach a desired heating power or energy level, in particular the heating unit (104, 302) comprises an electric heater, the power of which can be commanded by the control unit (500).

[0065] In a thirtieth aspect according to any one of the preceding aspects, the disinfection treatment comprises a disinfection treatment period (DPt) corresponding to A 0_achieved ≧A 0_set Complete if

[0066] In a thirty-first aspect according to the preceding aspect, the control unit (500) is further configured to store the time period DPt for the disinfection procedure in a memory, in particular a digital memory, or the method comprises this.

[0067] In a thirty-second aspect according to any one of the preceding aspects, the control unit (500) determines a start time of a subsequent disinfection treatment based on the duration DPt of a preceding disinfection treatment.

[0068] In a thirty-third aspect according to any one of the preceding aspects, the control unit (500) is configured to receive or store a threshold temperature value T T , and the achieved disinfection amount A 0_achieved The step of the disinfection procedure of calculating the temperature of the heated liquid is started when the measured temperature of the heated liquid is equal to or greater than the threshold temperature value T, in particular when the measured temperature of the heated liquid is equal to or greater than the liquid reference temperature T ref or the method includes this.

[0069] In a thirty-fourth aspect according to any one of the preceding aspects, the achieved disinfection amount A 0_achieved is calculated based only on the time period during which the measured liquid temperature of the liquid exceeds the threshold temperature value TT.

[0070] In a thirty-fifth aspect according to any one of the preceding aspects, the fluid circuit (100) comprises a treatment solution preparation unit (110) connected to the dialysis supply line (107) and configured to mix water coming from the water inlet (101) with one or more concentrated solutions to prepare the dialysis solution, the treatment solution preparation unit (110) including one or more concentrate containers containing one or more concentrated solutions connected to the dialysis supply line (107).

[0071] In a thirty-sixth aspect according to the preceding aspect, the treatment solution preparation unit (110) includes a separate concentrate pump for delivering a concentrated solution, and the treatment solution preparation unit (110) further includes at least one conductivity cell (114, 118) configured to provide a signal representative of a solution concentration in the dialysis solution.

[0072] In a thirty-seventh aspect according to any one of the preceding aspects, the thermal disinfection system (1) is operatively connected to the control unit (500), and the set disinfection amount value A 0_set and at least one user interface (501), in particular a graphic user interface (501), configured to receive from a user at least one piece of information in the group between the threshold temperature value TT, the z value and the sample rate.

[0073] In a thirty-eighth aspect according to any one of the preceding aspects, the fluid circuit (100) includes a disinfectant source configured to inject a disinfectant solution into the circuit before, during, or after the thermal disinfection procedure.

[0074] In a thirty-ninth aspect according to any one of the preceding aspects, the dialysis supply line (107) is configured to receive water from the water inlet (101) and provide dialysis solution to an input of the dialyzer (150) during a blood treatment session.

[0075] In a fortieth aspect according to any one of the preceding aspects, the dialysis outlet line (108) is configured to receive dialysate from an outlet of the dialyzer (150).

[0076] In a forty-first aspect according to any one of the preceding aspects, the fluid circuit of the water purification device (300) comprises a fluid circuit, at least one pump (450), and the thermal disinfection treatment includes a step of operating the at least one pump (450) to determine a flow of the heated water in the fluid circuit, at least during the thermal disinfection treatment.

[0077] In a forty-second aspect according to any one of the preceding aspects, the fluid circuit (100) of the water purification device (300) includes a pretreatment module (160) having a particulate filter and a bed of activated carbon, in particular, the particulate filter configured to remove particles such as clay, silt and silica from the influent water, and the bed of activated carbon configured to remove at least one of hypochlorite, chloramines and chlorine.

[0078] In the forty-third aspect according to any one of the preceding aspects, the fluid circuit (100) of the water purification device (300) includes a reverse osmosis RO module (170) configured to remove at least one of microorganisms, pyrogens, and ionic substances from the water by the effect of reverse osmosis, and in particular, the reverse osmosis RO module (170) is arranged downstream of the pre-treatment module (160).

[0079] In a forty-fourth aspect according to any one of the preceding aspects, the fluid circuit of the water purification apparatus (300) includes a post-treatment module (180) configured to remove ions such as aluminum, lead, cadmium, chromium, sodium and / or potassium from the influent water, the post-treatment module (180) including an electrodeionization device EDI.

[0080] In a forty-fifth aspect according to any one of the preceding aspects, the control unit (500) fluid_mes and the measured local pressure value P atm When the heating unit (104) is driven to heat the liquid based on - the local pressure value P atm Based on the set temperature T of the liquid fluid_set determining the set temperature T fluid_set is optionally comprised between 50°C and 105°C, in particular between 70°C and 100°C; - the measured temperature value T fluid_mes Based on the above, the set temperature T fluid_set and controlling said heating unit (104) to heat up to, and in particular not beyond, a temperature of 100.degree. [Brief description of the drawings]

[0081] Certain embodiments and aspects of the present invention are described below with reference to the accompanying drawings, which are provided by way of example only. [Figure 1] FIG. 1 is a schematic diagram of the fluid circuit of the blood processing device. [Diagram 2] FIG. 2 is a schematic diagram of an alternative embodiment of a fluid circuit of a blood processing device. [Diagram 3] FIG. 2 is a schematic diagram of a fluid circuit of the water purifier. [Figure 4] FIG. 1 is a schematic diagram of a disposable set of a peritoneal dialysis machine. [Diagram 5] FIG. 2 is a detailed diagram of the fluid circuit of the water purification device. [Figure 6] 1 shows the evolution of the time required to complete the thermal disinfection procedure as a function of the liquid temperature. [Figure 7] 1 is an exemplary curve of the liquid temperature in a fluid circuit as a function of elapsed time during a thermal disinfection procedure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0082] definition In this detailed description, corresponding parts illustrated in the various figures are designated by the same reference numerals. The drawings may be represented in a non-scale manner, and therefore the parts and components illustrated in the drawings that are relevant for the purposes of the present invention may be represented in a schematic manner only.

[0083] Upstream and / or downstream The terms upstream and downstream refer to the direction of forward movement or trajectory of fluid configured to flow within the fluid line during normal use of the device or during a disinfection procedure.

[0084] Detailed Description Blood processing device 10 According to the example of FIG. 1, the thermal disinfection system 1 comprises a dialysis machine 10 having a fluid circuit 100 comprising a supply arrangement 107a providing at least one dialysis supply line 107, which is generally adapted to transport a liquid, in particular water or purified water, from an inlet 101 towards an inlet 152 of the dialyzer 150 during a dialysis treatment.

[0085] The fluid circuit 100 further comprises a return arrangement 171 having at least one dialysis discharge line 108 intended to transport dialysate (spent dialysate and / or liquid ultrafiltered from the blood through the semipermeable membrane 151 of the dialyzer 150) from the outlet 153 of the dialyzer 150 towards an outlet indicated diagrammatically at 129 in FIG. 1 .

[0086] The fluid circuit 100 cooperates with a blood circuit (not shown). The specific structure of the blood circuit is not essential with reference to the present invention. Thus, a brief description of possible embodiments of the blood circuit is given, which is provided merely as a non-limiting example. The blood circuit comprises a blood removal line 155 designed to remove blood from the vascular access and connected to the inlet of the primary chamber or blood chamber of the dialyzer 150. The blood circuit further comprises a blood return line 154 designed to return the treated blood to the vascular access and connected to the outlet 154 of the primary chamber of the dialyzer 150.

[0087] The primary chamber of the dialyzer 150 communicates with the secondary chamber through a semipermeable membrane 151 made, for example, of a hollow fiber type or a plate type.

[0088] During dialysis treatment, the dialysis supply line 107 is connected to the dialyzer treatment fluid inlet 152 of the secondary chamber, and the dialysis discharge line 108 is connected to the dialyzer treatment fluid outlet 153 of the secondary chamber. The blood circuit may also include one or more air separators, for example, in the return blood line, upstream of the safety valve. Other air separators may be present in the blood circuit, arranged along the blood removal line. The dialysis machine 1 may also include one or more blood pumps, for example, positive displacement pumps such as peristaltic pumps, for example, on the blood removal line and optionally on the return blood line of the blood circuit.

[0089] For the purpose of controlling the liquid passage to / from the dialyzer 150, a flow pump 120 and a suction pump 122 may be included, arranged respectively on the dialysis fluid supply line 107 and the dialysis fluid discharge line 108, and may also be operably connected to the control unit 500 of the dialysis machine 1. When preparing the liquid for treating the patient, purified water enters the supply configuration at the inlet 101. A heater 104 is also provided on the liquid supply line 107 and is operably connected to the control unit 500. When the inlet valve 102 is open, the heater 104 is configured to heat the water during the blood treatment session, i.e., at a temperature of about 37°C. Instead, the heater 104 is configured to heat the water during the disinfection treatment at a higher temperature T, i.e., 65°C < T < 100°C. The heater may include an electrical resistance configured to be heated due to the flow of an electric current. The amount of heating energy or instantaneous power provided to the water by the heater 104 may be set by controlling the amount of electric current flowing through the electrical resistance. Instead, the control unit 500 may be configured to periodically activate and deactivate the heater to provide a preset average heating energy to the water.

[0090] The purified heated water is collected in a tank 105 fitted with an expansion tube 106, which eventually allows the gases dissolved in the liquid to be released to the atmosphere.

[0091] The apparatus may also include a treatment solution preparation unit 110, which may be of any known type, including, for example, one or more concentrate containers (A concentrate 111 and B concentrate 115) and separate concentrate pumps for concentrate delivery (A pump 112 and B pump 116), and at least first and / or second conductivity cells 114, 118.

[0092] The concentrate pumps 112, 116 are arranged in the delivery lines 112a, 116a to allow metered mixing of water and concentrated 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 a mixture of liquids formed at a separate injection point where the dialysis supply line 107 joins the delivery lines 112a, 116a and 2) a conductivity value of this mixture measured by separate conductivity sensors 114, 118 arranged in the dialysis supply line 107 downstream of the injection point between the dialysis supply line 107 and the separate delivery lines 112a, 116a. Instead of the conductivity sensors 114, 118, concentration sensors 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 liquid conductivity is immediately measured by the sensor 114 downstream of the first injection point. A second injection point may be placed downstream of the first conductivity sensor 114, and the second concentrate is mixed with the liquid in the dialysis supply line. The conductivity or concentration of the prepared treatment solution may then be measured with a second conductivity sensor 118 before being directed to the dialyzer 150 during the blood treatment session. The dialysate may for example contain sodium, calcium, magnesium and potassium ions, and the treatment solution preparation unit 110 may be configured to prepare the dialysate based on a comparison between a target conductivity value and an actual conductivity value of the dialysate measured by the conductivity sensors 114, 118. The concentrate pumps 112, 116 are generally configured to control the concentration of certain ionic substances in the dialysate. In general, it is advantageous to control the sodium and bicarbonate concentrations of the dialysate. According to an embodiment, only one conductivity sensor 118 may be used to control the dialysate preparation. The conductivity sensor 118 is placed on the supply arrangement downstream of the injection points of the first and second concentrates. Of course, other types of treatment fluid preparation units 110 having single or additional concentrate sources and / or single or multiple pumps may be equivalently used, and in fact, the treatment fluid preparation unit 110 may be any known system configured for the online preparation of dialysis fluid from water and concentrate.

[0093] The fluid circuit 100 also includes a supply liquid temperature sensor 127 operably connected to the control unit 500 and configured to provide a signal representative of the temperature of the water in the circuit. A temperature check of the liquid is useful both during a standard blood processing session and during a disinfection procedure of the liquid lines, as described in more detail in the following description. The supply liquid temperature sensor 127 is disposed on the supply line 107. According to an embodiment, the temperature sensor 127 may be disposed downstream of the heater 104 to monitor the liquid outlet temperature. A second liquid supply temperature sensor 127' may also be provided on the supply line 107 and disposed upstream of the heater 104. The treatment liquid outlet 130 of the dialysis supply line 107 may be connected through a treatment liquid removable connector 138 to a liquid inlet 152 of the dialyzer 150 when treating a patient.

[0094] When disinfecting the supply arrangement 107a, a disinfectant and / or a heating liquid is circulated in the dialysis supply line 107. In particular, the treatment liquid removable connector 138 of the dialysis supply line 107 is disconnected from the dialyzer 150 and connected to a supply line parking connector 136 provided on the chassis of the dialysis machine. The supply recirculation circuit 174 is designed to receive liquid from the supply line parking connector 136 and redirect said liquid to the supply arrangement 107a, in particular to the dialysis supply line 107 at a first connection point 140 immediately downstream of the inlet valve 102 and upstream of the heater 104. In such a piping arrangement, an auxiliary liquid loop path is defined that allows liquid recirculation in said closed loop path including at least a part of the supply arrangement 107a and the supply recirculation circuit 174. If the supply line 107 is provided with a second liquid supply temperature sensor 127', the latter is interposed between the first connection point 140 and the inlet of the heater 104.

[0095] During the thermal disinfection procedure, water is supplied through the inlet 101 and heated by the heater 104 to a desired disinfection temperature. For example, the heater may be commanded by the control unit 500 to heat the water at a temperature comprised between 70° C. and 100° C. The flow pump 120 operates to continuously pump the liquid in the auxiliary liquid loop path. The heated water passes along the supply arrangement 107a, the treatment liquid outlet 130, the treatment liquid supply tube 131, the supply tube parking connector 136, and the supply recirculation circuit 174 and returns to the supply device 107a. In other words, the heated water is recirculated in the closed auxiliary liquid loop path for a predetermined time sufficient to perform thermal disinfection of a part of the fluid circuit upstream of the dialyzer 150.

[0096] A first return valve 123 is placed in the supply recirculation circuit 174 to respectively allow and prevent the circulation of liquid in the auxiliary liquid loop path. The first return valve 123 is open during thermal disinfection. Optionally, the disinfection efficiency during the thermal disinfection procedure may be increased by using a disinfectant mixed with water. Hot water mixed with a disinfectant solution may determine an improvement in terms of disinfection and may allow to reduce the time required to reach a set disinfection threshold.

[0097] In an alternative embodiment, the heater 104 may be disposed in the supply recirculation circuit 174 to heat the water in the loop path. Additionally, as described above, a first heater may be provided on the supply line 107 and a second heater may be provided on the supply recirculation circuit 174.

[0098] The fluid circuit 100 also comprises a return arrangement 171 configured to remove dialysate from the dialyzer 150 during a dialysis treatment and direct it to the outlet 129. The dialysis discharge line 108 may comprise a separate return fluid removable connector 139 configured to be removably connected to a fluid outlet 153 of the dialyzer 150 when treating a patient in order to receive the dialysate and direct it to the outlet 129. The outlet is adapted for connection to a waste bag or drain. A suction pump 122 and a second flow meter (not shown) are disposed on the dialysis discharge line 108. The first and second flow meters may be used to control (in a known manner) the fluid balance of a patient connected to the blood circuit during a dialysis treatment session. A conductivity sensor (not shown) may be provided on the dialysis discharge line 108 immediately downstream of the dialyzer 150 to measure the conductivity of the dialysate.

[0099] Furthermore, a return fluid temperature sensor 128 is also disposed on the dialysis exhaust line 108 to measure the temperature of the liquid circulating in the return arrangement 171. The return fluid temperature sensor 128 is preferably disposed downstream of the suction pump 122. A first outlet valve 125 is disposed in the return arrangement 171 immediately upstream of the outlet 129 to allow or prevent liquid in the return arrangement from being directed to the outlet.

[0100] During the disinfection procedure, the heated liquid, optionally mixed with a disinfectant solution, is circulated in the dialysis discharge line 108. In particular, the return liquid removable connector 139 of the dialysis discharge line 108 is disconnected from the dialyzer 150 and connected to a return line parking connector 137 provided on the chassis of the dialysis machine. The return recirculation circuit 173 is designed to receive the liquid from the return line parking connector 137 and redirect it to the return arrangement 171, in particular to the dialysis discharge line 108 at the outlet 129, preferably at the fourth connection point 143 immediately upstream of the first outlet valve 125. In such a piping arrangement, a liquid loop path is defined that allows liquid recirculation in a closed loop path including at least a part of the return arrangement 171 and the return recirculation circuit 173. In one embodiment (not shown), only a liquid loop path is present to recirculate the liquid, in particular during the disinfection procedure. No auxiliary liquid loop path is present on the "clean side" of the fluid circuit. In this embodiment, no supply recirculation circuit is provided. In the case of thermal disinfection only, hot water, heated to a desired disinfection temperature, for example by heater 104, is supplied to the liquid loop path via supply arrangement 107a. For example, water at a temperature between 70° C. and 100° C. may be used.

[0101] It should be noted that hot water may be provided via the bypass line 109 shown in Figure 1, or via any other fluid connection between the dialysis supply line 107 (including heater 104) and the fluid loop path. Alternatively, or in combination, an additional heater (not shown) may be provided in the return arrangement 171 or in the return recirculation circuit 173 to heat the water.

[0102] In another embodiment, a heat exchanger may be used to transfer heat from the liquid in the supply arrangement 107a to the liquid in the return arrangement 171 to reach the desired temperature of the liquid in the liquid loop path. An additional heater in the return arrangement may or may not be present.

[0103] During the thermal disinfection procedure, the control unit 500 commands the suction pump 122 to continuously pump the liquid in the liquid loop path. In particular, the heated water passes through the return arrangement 171, the return recirculation circuit 173, the return tube parking connector 137, the treatment liquid return tube 132, the dialysate return inlet 133 and returns to the return arrangement 171. In other words, the heated water is recirculated in the closed liquid loop path for a predetermined time sufficient to perform thermal disinfection of a part of the fluid circuit downstream of the dialyzer 150. A second return valve 124 is placed in the return recirculation circuit 173 to allow or prevent the circulation of liquid in the liquid loop path. The second return valve 124 is open during thermal disinfection. In particular, disinfection of the liquid loop path may alternatively be obtained using a disinfectant mixed with water. Disinfection may be achieved in combination or not with heating of the disinfectant solution.

[0104] The fluid circuit 100 according to Fig. 1 also includes a feedforward arrangement 172 configured to allow the liquid of the supply arrangement 107a to be sent to a waste bag or a drain, bypassing the liquid loop path, i.e. bypassing a part of the return arrangement 171 upstream of the first outlet valve 125 and bypassing the return recirculation circuit 173. In the embodiment of Fig. 1, the feedforward arrangement 172 is connected on one side to the dialysis supply line 107 or the bypass line 109 and on the other side directly to the outlet 129 of the return arrangement 171. However, it should be noted that the feedforward arrangement 172 may also be connected directly to a drain (or a waste bag) without being connected to the return arrangement 171. In other words, in some embodiments, the feedforward arrangement 172 has an independent discharge end, is not directly connected to other lines of the fluid circuit and can be freely positioned.

[0105] The feedforward arrangement 172 of Figure 1 is connected to the auxiliary liquid loop pathway (particularly the supply arrangement 107a) at a second connection point 141. Liquid from the auxiliary liquid loop pathway may be withdrawn at the second connection point 141 and directed to the outlet 129 without circulating within the liquid loop pathway before being discharged. In particular, in the example, the feedforward arrangement 172 is connected to the return arrangement 171 at a sixth connection point 145 located downstream of the fourth connection point 143 at which the return recirculation circuit 174 connects to the return arrangement 171.

[0106] The feedforward arrangement 172 comprises a second outlet valve 126 for allowing or preventing liquid in the supply arrangement from being directed through the feedforward arrangement to the outlet.

[0107] The fluid circuit 100 may also include a bypass line 109 connecting the dialysate supply line 107 and the dialysate drain line 108 and 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 valves 121 open upon command of the control unit. Furthermore, the control unit 500 closes the liquid passage towards the treatment zone and directly connects the inlet 101 to the dialysate drain line 108 through the bypass line 109.

[0108] In the example of Fig. 1, the first path of the bypass line 109 between the second connection point 141 and the fifth connection point 144 is common to the feedforward arrangement 172. In other words, by appropriately controlling the opening and closing of the bypass valve 121 and the second outlet valve 126, it is possible to direct the liquid from the supply arrangement 107a towards the return arrangement 171 or towards the outlet 129. Moreover, both the bypass valve 121 and the second outlet valve 126 may be open at the same time, which allows the liquid to be directed from the supply arrangement 107a towards both the return arrangement 171 and towards the outlet 129. The bypass line 109 is connected to the return arrangement 171 at a third connection point 142 upstream of the suction pump 122.

[0109] According to the embodiment shown in Fig. 2, the fluid circuit 200 may include a shunt tube 132a that directly connects the treatment fluid outlet 130 of the supply line 107 to the dialysate return inlet 133 of the dialysis drain line 108 during a thermal disinfection procedure. During a thermal disinfection procedure, hot water passes through the supply line 107, the shunt tube 132a, the drain line 108, and toward the outlet 129. Additionally, the fluid circuit 100 may include an auxiliary bypass line 109a that connects the drain line 108 to the supply line 107 at the connection point 140 at a connection point 147 upstream of the outlet 129. In this configuration, during a thermal disinfection procedure, hot water passes through the supply line 107, the shunt tube 132a, the drain line 108, and through the auxiliary bypass line 109a that defines a loop path for recirculating the hot water.

[0110] The dialysis machine also includes a pressure sensor 162 configured to provide a signal representative of the air pressure surrounding the dialysis machine. The pressure sensor 162 is operably connected to a control unit 500, which is configured to receive the representative pressure signal from the pressure sensor 162 and provide an air pressure value at an output.

[0111] The device may also comprise a user interface 501 (e.g. a graphic user interface or GUI) operatively connected to the control unit 500. The control unit 500 may comprise, for example, one or more digital microprocessor units, or one or more analog units, or any other combination of analog and digital units. In connection with, for example, a microprocessor unit, the unit is programmed when it executes a special program (for example a program coming from outside or directly integrated on the microprocessor card), defining a number of functional blocks constituting means each designed to perform a separate operation. The control unit 500 of the dialysis machine 1 is connected to the (graphic) user interface 501, via which it is possible to control, for example, the liquid set temperature T, as will be described in more detail in the thermal disinfection procedure section. fuid_set , threshold temperature TT, and set disinfection amount A 0_setThe (graphical) user interface 501 may also receive instructions to perform a treatment session, i.e. a blood treatment session. That is, the user interface 501 may receive target values ​​such as blood flow Q b , dialysate flow rate Q di , injectate flow rate Q inf The control unit 500 may receive the patient weight loss WL (if applicable). Furthermore, the control unit 500 may receive the detection values ​​of the sensors of the device, such as the flow meter mentioned above, the conductivity sensor of the treatment fluid preparation unit 110, the conductivity sensor in the dialysis discharge line 108, and the first and second supply liquid temperature sensors 127, 127' and the return liquid temperature sensor 128. Based on the received instructions and on the programmed operating modes and algorithms, the control unit 500 drives the actuators of the device, such as the blood pump, the aforementioned flow and suction pumps 120, 122 and the treatment fluid preparation unit 110, to carry out a blood treatment session or to carry out a disinfection procedure. The control unit 500 may also provide the user with information (e.g., process and machine parameters) regarding the thermal disinfection procedure of the fluid circuit 100 through a (graphic) user interface 501.

[0112] Water Purifier 300 According to the embodiment shown in Figures 3, 4 and 5, the thermal disinfection system 1 comprises a water purification device 300 that is fluidly connectable to one or more medical devices, i.e. peritoneal dialysis devices or blood treatment devices, to provide water purification. In particular, this embodiment is directed to both the water purification device 300 that is connectable to a medical device (medical device not included) and to a medical device that comprises the water purification device 300, in particular a peritoneal dialysis device or the aforementioned blood treatment device 10.

[0113] In particular, the water purification device 300 may be fluidly connected to the inlet 101 of the blood processing device 10 described above to provide water purification. Alternatively, the water purification device 300 may be fluidly connected to a peritoneal dialysis machine disposable set 40 (see FIG. 4).

[0114] A detailed description of the internal circuitry of the water purification device 300 is not essential for purposes of the present invention. In any event, an exemplary embodiment of the water purification device 300 shown in Figures 3 and 5 that is connectable to a peritoneal dialysis machine is described herein below.

[0115] 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. FIG. 3 illustrates an exemplary embodiment of the main functional parts of the water purification device 300 including the pre-treatment module 160, the reverse osmosis (RO) module 170, and the post-treatment module 180.

[0116] The water purification device 300 includes an inlet port 399 for supplying water from a water source 398, such as a water mains, to the water purification device 300 for purification. The inlet water from the water source is supplied to the pretreatment module 160 through the inlet port 399.

[0117] The pretreatment module 160 processes the influent water with a particle filter and a bed of activated carbon. The particle filter is configured to remove particles such as clay, silt, and silicon from the influent water. The particle filter is configured to block micrometer-sized particles, and optionally larger endotoxin molecules, from the influent water. The bed of activated carbon is configured to remove chlorine and chlorine-containing compounds from the influent water and to absorb toxic substances and pesticides. In an exemplary embodiment, the bed of activated carbon is configured to remove one or more of hypochlorite, chloramine, and chlorine. In a further exemplary embodiment, the bed of activated carbon is also configured to reduce organic compounds (TOC total organic carbon), including pesticides, in the influent water. In some embodiments, the particle filter and the bed of activated carbon are integrated into a single consumable part. The consumable part is replaced at a predetermined interval, for example, depending on the influent water quality. The quality of the influent water is, for example, inspected and determined by a qualified person before the first use of the water purification device 300 at the point-of-care.

[0118] Optionally, the pretreatment module 160 includes a reverse osmosis (RO) membrane and an ion exchange device to protect downstream devices such as a polisher. Thus, the pretreatment module 160 filters the influent water and delivers the pretreated water to the downstream RO module 170. The RO module 170 removes impurities such as microorganisms, pyrogens, and ionic substances from the pretreated water by the effect of reverse osmosis. The pretreated water is pressurized by a pump and forced through the RO membrane to overcome the osmotic pressure. The RO membrane is, for example, a semipermeable membrane. Thereby, the pretreated water stream, called the feed water, is divided into a wastewater stream and a permeate stream. In an exemplary embodiment, the reject water may pass through one or both of the first rejection path and the second rejection path. The first rejection path recirculates the reject water to the feed liquid path of the RO pump so as to be fed back to the RO device again. The recycled reject water increases the feed flow to the RO device to obtain sufficient flow through the reject side of the RO membrane to minimize scaling and fouling of the RO membrane. The second reject path directs the reject water to a drain so that the reject concentration level is low enough to obtain the proper required permeate concentration. If the feed water has a low solute content, a portion of the reject flow may also be directed back to the inlet side of the RO membrane, thereby increasing the water efficiency of the water purification apparatus 300.

[0119] Thus, the RO module 170 processes the pretreated water and delivers the permeate to the downstream post-treatment module 180. The post-treatment module 180 polishes the permeate to further remove ions from the permeate. The permeate is polished using a polishing device such as an electrodeionization (EDI) device, or a mixed bed filter device. The EDI device utilizes electrodeionization to remove ions from the permeate such as aluminum, lead, cadmium, chromium, sodium and / or potassium that have permeated the RO membrane. The EDI device utilizes electricity, ion exchange membranes and resins to deionize the permeate and separate the dissolved ions, i.e., impurities, from the permeate. The EDI device produces polished water that is polished by the EDI device to a purity level higher than that of the permeate. EDI has an antibacterial effect on the product water, and can reduce the amount of bacteria and endotoxins in the water due to, among other things, the electric field in the EDI device. The mixed bed filter device includes a column or vessel with a mixed bed ion exchange material. The purified water, also referred to as product water, is then ready to be delivered to a point of use from the product port 328 of the water purification device 300. The product water is suitable for dialysis, i.e., hemodialysis or peritoneal dialysis. In a further embodiment, the product water may be used for infusion into a patient's bloodstream.

[0120] Optionally, the water purification device 300 includes a drain port 318, which in one exemplary embodiment is used to receive spent liquid, e.g., from the PD patient via drain line 64, for further transport to a drain 339 of the water purification device 300 via a first drain path 384 within the water purification device 300. As a further option, the drain port 318 receives a sample of the prepared mixed solution for further transport within the water purification device 300, e.g., to a conductivity sensor located within the first drain path 384.

[0121] In an exemplary embodiment, a disposable line set 40 for peritoneal dialysis, shown in FIG. 4, may be fluidly connected to the product port 328 of the water purification device 300 to receive purified water.

[0122] The disposable set 40 includes an upstream water line segment 64a that extends to a water inlet 66a (FIG. 2) of the water reservoir 66. A downstream water line segment 64b extends from a water outlet 66b (FIG. 2) of the water reservoir 66 to the cassette 42. In the illustrated embodiment, the upstream water line segment 64a begins at a water line connector 68 that is located upstream of the water reservoir 66 and is configured to connect to a product port 328 of the water purifier 300. The water purifier 300 outputs purified water and, for example, water suitable for peritoneal dialysis ("WFPD"). WFPD is water suitable for making dialysate for delivery to the peritoneal cavity of a patient P.

[0123] In one embodiment, a sterile germicidal grade filter 70a is disposed upstream of a downstream sterile germicidal grade filter 70b. The filters 70a and 70b may be disposed in the water line segment 64a upstream of the water reservoir 66. The sterile germicidal grade filters 70a and 70b may be pass-through filters without a rejection line. The pore size for the germicidal filter may be less than 1 micron, such as, for example, 0.1 or 0.2 microns. Suitable sterile germicidal grade filters 70a and 70b may 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 sterile germicidal grade filters are disposed in the water line segment 64a upstream of the water reservoir 66. The one or more sterile germicidal grade filters may be disposed near the water reservoir 66 to facilitate collapsing of the liquid line set 40. In a further alternative embodiment, there is no sterile-grade filter in the water line segment 64a, and the sterile-grade filter may be replaced with, for example, one or more ultrafilters disposed in the product path of the water purification device 300.

[0124] The disposable line set 40 includes a patient line 50 that extends from a patient line port of the cassette 42 and terminates in a patient line connector 52 that is connected to a patient. The patient line connector 52 connects to a patient transfer set 54, which in turn connects to an indwelling catheter located in the patient's abdominal cavity. The disposable line set 40 also includes a drain line 56 that extends from a drain line port of the cassette 42 and terminates in a drain line connector 58. The drain line connector 58 may be removably connected to a drain port 318 of the water purification device 300.

[0125] The disposable set 40 further comprises a final bag or sample line 72 extending from a final bag or sample port of the cassette 42. The final bag or sample line 72 terminates in a connector 74, which may be connected to a mating connector on a premixed final fill bag of dialysate, or to a sample bag or other sample collection container. The final bag or sample line 72 and connector 74 may alternatively be used for a third type of concentrate, if desired.

[0126] The disposable set 40 includes a first concentrate line 76 extending from a first concentrate port of the cassette 42 and terminating in a first cassette concentrate connector 80a. The first cassette concentrate connector 80a is configured to be fluidly connected to a first concentrate container 84a holding a first, e.g., glucose concentrate. The second concentrate line 78 extends from a second concentrate port of the cassette 42 and terminates in a second cassette concentrate connector 82a. The second container concentrate connector 82b is configured to be fluidly connected to a second concentrate container 84b holding a second, e.g., buffer concentrate.

[0127] In one embodiment, to begin treatment, patient P loads cassette 42 into the cycler and, in a random or designated order, (i) places heater / mixing bag 62 on the cycler, (ii) connects upstream water line segment 64a to product port 328 of water purification device 300, (iii) connects drain line 56 to drain port 318 of water purification device 300, (iv) connects first cassette concentrate connector 80a to first vessel concentrate connector 80b, and (v) connects second cassette concentrate connector 82a to second vessel concentrate connector 82b. Figure 5 illustrates a detailed embodiment of water purification device 300.

[0128] The line style differences of the flow paths in FIG. 5 illustrate the main flows in the first liquid path (bold lines) and the second liquid path (dashed lines) during typical disinfection. Referring now to FIG. 5, an RO device 301 is configured to generate a purified liquid flow and a rejected liquid flow. In more detail, the RO device 301 comprises a feed inlet 301a, a permeate outlet 301b, and a reject outlet 301c. An RO membrane 324 separates the feed inlet 301a and the reject outlet 301c from the permeate outlet 301b. A feed path 391 is connected to the feed inlet 301a for transporting the feed to the feed inlet 301a. The feed path 391 is comprised of a tank 350 for collecting liquid and an RO pump 450 configured to pump the feed to the feed inlet 301a. The RO pump 450 is disposed downstream of the tank 350. The RO pump 450 is configured to be controlled by the control unit to a particular pump speed that corresponds to a particular flow rate of permeate.

[0129] The water purification apparatus 300 further comprises a purified liquid path 371 connected to the permeate outlet 301b and the product port 328 for transporting purified liquid from the permeate outlet 301b to the product port 328. The purified liquid path 371 comprises a permeate path 371a, a polisher liquid path 371b, and a product liquid path 371c. The polisher liquid path 371b includes a polisher device 306, for example, an EDI device or a mixed bed filter device. The bypass path 371d is configured to bypass the polisher device. The three-way valve 305c is configured to be controlled by the control unit 500 to selectively direct the permeate flow into the polisher device 306 or into the bypass path 371d to bypass the polisher device 306. The first drain path 384 is connected to the drain port 318 and the drain 339 for passing liquid from the drain port 318 to the drain 339. The first drain path 384 here implements a portion of a cycler drain path present inside the water purification device 300. The first drain path is configured, for example, to transport drained PD solution from the patient to a drain 339 of the water purification device 300.

[0130] The water purification apparatus 300 is further configured to include a heating unit 302 (also referred to as heater 302) configured to heat the purified liquid produced by the RO device 301 downstream of the RO device 301. The heater 302 may include, for example, a heating element. The first recirculation path 381 is configured to circulate the heated purified liquid inside the water purification apparatus 300 from a point downstream of the RO device 301 and downstream of the heater 302 to the pump 450 and the feed liquid path 391 upstream of the heater 302. The heated purified liquid is then recirculated to the tank 350 and fed back to the feed inlet 301a of the RO device 301. However, alternatively, the heated purified liquid is directly recirculated to the liquid line upstream of the RO pump 450. The reject flow is fed back to the feed liquid path 391 via the first rejection path 385b. The first rejection path 385b is connected to and in fluid communication with the rejection outlet 301c and the supply path 391. The second rejection path 389 is connected to and in fluid communication with the rejection outlet 301c of the tank 350. However, alternatively, the second rejection path 389 is connected to and in fluid communication with the supply path 391. The second drain path 388 may be configured to supply rejection fluid from the rejection outlet 301c to the drain 339. The valve 305b, a three-way valve, is configured to selectively direct rejection flow to either the second rejection path 389 or the second drain path 388. The constant flow device 318 is configured to control the flow rate in the second rejection path upstream of the three-way valve 305b.

[0131] The water purification apparatus 300 may include a second recirculation path 375 disposed with the flow control device 305a. In one exemplary embodiment, the second recirculation path 375 is referred to as a second liquid path. The second recirculation path 375 is configured to transport the heated purified liquid to the interior of the water purification apparatus 300. In an exemplary embodiment, the second drain path 388 is also referred to as a second liquid path.

[0132] The control unit 500 is configured to perform a thermal disinfection process of the water purification apparatus 300. This means controlling the cleaning of all or part of the liquid path of the RO module 170 and the post-treatment module 180 of the water purification apparatus 300 that comes into contact with the liquid. The liquid path is meant here to include the tubes, lines, channels inside the water purification apparatus 300, ports, tanks, components such as valves, control devices, etc. The control unit 500 is configured to cause the water purification apparatus 300 to control the heating of the purified liquid from the RO device 301 using the heater 302. The heater 302 includes, for example, a heating rod. In one exemplary embodiment, in order to efficiently heat the purified liquid in the permeate path 371a, a part of the permeate path 371a is wrapped around the heating rod. Alternatively, the heater 302 includes a heat exchanger configured to exchange heat between a heating medium and the liquid in the permeate path 371a. In one embodiment, the heater 302 is configured to heat the purified liquid at a specific heating rate. By controlling the power to, and thus the power of, the heater 302, the heating rate of the heater 302 can be adjusted. However, the heating rate also depends on the flow rate of the purified liquid.

[0133] The valve arrangement 305 is configured to direct the heated purified liquid to the first liquid path or the second liquid path, and may include, but is not limited to, one or more of a flow control device 305a, a three-way valve 305b, a three-way valve 305c, and a product water valve 305d.

[0134] The water purification device 300 comprises one or more temperature sensors 303, 313, 323. The temperature sensor 303 is configured to measure the temperature of the water downstream of the heater 302. In particular, the temperature sensor 303 is arranged near the outlet of the heater 302 so that the water temperature can be assumed as the maximum temperature of the water in the circuit. When the heated permeate is led to the first recirculation path 381, the temperature of the heated permeate indicates the temperature of the liquid in the first recirculation path 381. The temperature sensor 303 may be referred to as a high temperature sensor 303. Furthermore, a product liquid temperature sensor 313 may be arranged downstream of the EDI device 306 to measure the temperature of the water and thus the temperature of the liquid in the product liquid path 371c. Furthermore, a product liquid temperature sensor 323 may be arranged upstream of the heating unit 302. In particular, the temperature sensor 323 is arranged near the inlet of the heating unit 302 so that the water temperature can be assumed as the minimum temperature of the water in the circuit. The temperature sensor 323 may be referred to as a low temperature sensor 323.

[0135] The flow sensor 410 is configured to measure the flow rate of the purified liquid. The flow sensor 410 is here disposed in the liquid path 371a and is configured to measure the flow rate of the permeate liquid from the RO device 301. The flow sensor 410 is disposed downstream of the permeate outlet 301b and upstream of the heater 302, e.g., immediately downstream of the RO device 301.

[0136] To clean the water purification device 300, the control unit 500 is configured to control the valve arrangement 305 to recirculate the heated purified liquid in a first liquid path, for example the first recirculation path 381, until a first temperature-dependent criterion is met.

[0137] The water purification device 300 or the peritoneal dialysis device also comprises a pressure sensor 362 configured to provide a signal representative of the air pressure surrounding the dialysis device. The pressure sensor 362 is operably connected to a control unit 500, which is configured to receive the representative pressure signal from the pressure sensor 362 and provide an output with the air pressure value. The peritoneal dialysis device of the above-mentioned embodiment may also comprise a user interface 501 (e.g., a graphic user interface or GUI) operably connected to the control unit 500 similar to or equivalent to the user interface 501 of the blood processing device 10 described above. The control unit 500 may comprise, for example, one or more digital microprocessor units, or one or more analog units, or other combinations of analog and digital units. In connection with, for example, a microprocessor unit, the unit is programmed when it executes a special program (e.g., a program coming from outside or directly integrated on the microprocessor card), defining a number of functional blocks each constituting a means designed to perform a distinct operation.

[0138] Thermal disinfection procedure The present invention is directed to a thermal disinfection system 1 configured to perform a disinfection procedure of a fluid circuit of a medical device 10, such as the blood treatment device 10 described above. Alternatively, the thermal disinfection system 1 is configured to perform a disinfection procedure of a water purification system 300 that is fluidly connectable to one or more medical devices to provide water, according to the above description. The medical devices may be one or more blood treatment devices 10 or home peritoneal dialysis devices. In yet another embodiment, the thermal disinfection system 1 is configured to perform a disinfection procedure of a peritoneal dialysis device, in particular of the liquid lines of the peritoneal dialysis device, which may comprise disposable or usable liquid lines inside the peritoneal dialysis device.

[0139] The disinfection procedure includes at least the steps of receiving a temperature signal from the temperature sensor 127, 127', 128, 303, 313 and measuring a measured temperature value T of the liquid in the fluid circuit 100. fluid_mesincluding the step of determining. Further, the heat disinfection treatment includes the step of receiving a pressure signal from the pressure sensors 162, 362, and measuring the local atmospheric pressure value P atm including the step of determining, and measuring the temperature value T fluid_mes and the measured local atmospheric pressure value P atm including the step of driving the heating units 104, 302 to heat the liquid based on the measured local atmospheric pressure value P

[0140] The heat disinfection treatment also includes determining the set temperature T atm of the liquid based on the local atmospheric pressure value P fluid_set wherein the set temperature T fluid_set is included between 50°C and 105°C, particularly between 70°C and 100°C. Thus, the heat disinfection treatment includes controlling the heating units 104, 302 to heat the liquid up to, and in particular not exceeding, the set temperature T fluid_set based on the measured temperature value T fluid_mes In particular, the control unit 500 is configured to compare the measured temperature value T fluid_mes with the set temperature T fluid_set , calculate the difference between the measured temperature value T fluid_mes and the set temperature T fluid_set , and based on this difference, control the heating units 104, 302 to heat the liquid up to, and in particular not exceeding, the set temperature T fluid_set

[0141] The local atmospheric pressure value P atm is related to the liquid set temperature T fluid_set by a predetermined relationship, and this relationship defines the boiling point temperature BPT as a function of the local atmospheric pressure value P atm For example, water at a local pressure of 1 ATM has a boiling point temperature BPT equal to 100°C. A decrease in the local temperature determines a decrease in the boiling point temperature BPT according to a well-known relationship. According to the present invention, the liquid set temperature T fluid_set is such that 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 may be included between such boundaries.

[0142] ​ In particular, the thermal disinfection procedure is performed at a local air pressure value P that avoids boiling of the liquid in the fluid circuit 100. atm Based on the liquid set temperature T fluid_set For example, if the local pressure is 1 ATM, the liquid set temperature T fluid_set is heated as close as possible to 100° C. Higher temperatures are avoided to prevent boiling of the liquid in the fluid circuit 100, which may damage the circuit itself or determine insufficient disinfection efficiency.

[0143] The thermal disinfection procedure is performed according to a predetermined sample rate comprised between 0.01 Hz and 1000 Hz, in particular between 0.1 Hz and 500 Hz, by measuring the local air pressure P during the thermal disinfection procedure. atm The thermal disinfection procedure may include a step of continuously updating the measurement of the set temperature T during the disinfection procedure. The continuous updating may be periodic, random in time, or based on a pre-set algorithm. Similarly, the thermal disinfection procedure may include a step of continuously updating the measurement of the set temperature T during the disinfection procedure. fluid_set The local pressure P atm In other words, the local air pressure P may be continuously updated based on updated measurements of the local air pressure P during the disinfection procedure. atm If changes, the set temperature T fluid_set is changed accordingly. Thus, during the disinfection procedure, the local pressure P atm If increases, set temperature T fluid_set This increases the time required for the disinfection procedure, as described in more detail below.

[0144] Alternatively, the thermal disinfection process may be started by measuring the local pressure P by the pressure sensor 162, 362 only during the initial stage of the disinfection process or immediately prior to the start of the thermal disinfection process. atm Therefore, the liquid set temperature T fluid_set Also, the measured local pressure P atm and is kept constant during the entire thermal disinfection procedure. In this case, pressure fluctuations during the disinfection procedure are not taken into account and the set temperature T fluid_set does not change either.

[0145] According to ISO standard 15883-1:2009 "Washers and disinfectors part 1: general requirements, terms and definitions", cleaning is defined as "the removal of contamination from an article to the degree necessary for its further processing and its intended subsequent use". Disinfection is specified with reference to the time and temperature of thermal disinfection. According to this standard, whenever practical, thermal disinfection is preferred as it is more easily controlled and avoids the hazards to staff, patients and the environment that can occur with the use of chemical disinfectants.

[0146] The definition of a thermal disinfection process may be achieved by the "A0" method, which uses knowledge of the lethality of a particular process at various temperatures to evaluate the total lethality of a cycle and expresses this as an equivalent exposure time at a particular temperature. The term "A", also called disinfection dose, is defined as the equivalent time in seconds at 80°C that produces a particular disinfecting action against a microorganism with a defined "z" value, the "z" value being a measurement of the temperature relationship to the killing process and expressed in °C. Based on the definition, the "z" value corresponds to the increase in temperature required to reduce by 90% the "D" value of a particular microorganism. The "D" value is the time (decimal reduction time) required at a given temperature to kill 90% of the population of an individual microorganism. Thus, the "z" value of a microorganism increases in parallel with the increase in the resistance of this life form. The most resistant of all microorganisms, bacterial spores, have an average value of z=10°C. This z value is also adopted in the "A0" concept, even though spores are not an explicit goal targeted by thermal disinfection. However, the choice of the "z" value can be seen as a safety measure when specifying the disinfection parameters: "A0" is used instead of "A" when z=10°C. A given "A0" can be achieved with the most diverse temperature / time combinations.

[0147] The formula for calculating A0 is as follows:

number

[0148] The water temperature remains constant throughout the disinfection procedure (T constant "), the disinfection amount A0 may be calculated by the following formula:

number

[0149] FIG. 6 shows the liquid temperature T fluid_set 1 shows the evolution of the time required to complete the disinfection procedure as a function of the set disinfection amount A0_set in minutes, where the set disinfection amount A0_set is 600. The higher the liquid temperature, the shorter the time required to perform the disinfection procedure.

[0150] Based on the above, the thermal disinfection treatment is performed with a set disinfection dose A, which represents the required disinfection grade. 0_set and during the disinfection procedure, achieving a disinfection amount A 0_achieved In particular, the disinfection treatment further includes a step of calculating the achieved disinfection amount A 0_achieved Set the disinfection amount A 0_set Based on this comparison, the achieved disinfection amount A 0_achieved Set the disinfection amount A 0_set If the amount is more than the set amount, the disinfection process is stopped. 0_setmay be comprised between 40 and 2000, in particular between 200 and 1000, more particularly between 500 and 700. In particular, the achieved disinfection amount A 0_achieved The calculation step of is based on a reference liquid temperature T measured by at least one temperature sensor 127, 127', 128. ref (i.e., the liquid temperature T in °C measured at time “t” referenced in Equation 1 and Equation 2 reported above), based on a reference liquid temperature T ref is assumed for safety reasons to be the lowest liquid temperature substantially in the fluid circuit 100 during the thermal disinfection procedure. For example, according to the circuits of Figs. 1 and 2, the temperature sensor 127' may be called a low temperature sensor 127', the latter being located upstream of the heating unit 104 and close to the inlet of the heating unit 104. The low temperature sensor 127' thus detects the reference liquid temperature T ref Alternatively, the reference liquid temperature T ref may be measured by a return fluid temperature sensor 128, which is preferably located as close as possible to the drain outlet 129 when the fluid circuit 100 is in an open configuration, in which heated liquid flows from the inlet 101 through the dialysis supply line 107 and the dialysis discharge line 108 toward the drain outlet 129.

[0151] Alternatively, according to the circuit of Fig. 5, a temperature sensor 323, also called low temperature sensor 323, may be arranged upstream of the heating unit 302. Meanwhile, the liquid temperature value T fluid_mes may be measured by a temperature sensor 127, 303, also referred to as high temperature sensor 127, 303, located downstream of the heating unit 104, 302. In particular, the high temperature sensor 127, 303 is located near the outlet of the heating unit 104, 302 on the dialysis supply line 107. Thus, during the disinfection procedure, the high temperature sensor 127, 303 measures the liquid temperature value T fluid_mes The control unit 500 is configured to detect T fluid_mes =T fluid_set In particular, the control unit 500 is configured to control the heating units 104, 302 to maintain a desired liquid temperature T during the disinfection procedure. fluid_setThe heating power is controlled by varying the electrical energy provided.

[0152] The disinfection treatment is performed for the period A corresponding to the disinfection treatment period DPt. 0_achieved ≧A 0_set The disinfection procedure is completed when the disinfection amount achieved A is reached when the measured temperature of the heated liquid is equal to or greater than the threshold temperature TT. The disinfection procedure includes a step of storing this duration DPt for the completed disinfection procedure in a memory, in particular a digital memory. The control unit 500 is then configured to determine the start time of the subsequent disinfection procedure based on this duration DPt of the preceding disinfection procedure. The thermal disinfection procedure is also completed when the measured temperature of the heated liquid is equal to or greater than the threshold temperature TT. 0_achieved In particular, this measured temperature of the heated liquid may include receiving or storing a threshold temperature value T T such that the step of calculating the liquid reference temperature T ref Achieved disinfection amount A 0_achieved is calculated based only on the period during which the measured temperature of the liquid exceeds this threshold temperature TT. Conversely, during the period during which the measured temperature of the liquid is below this threshold temperature TT, the achieved disinfection amount A 0_achieved In other words, the achieved disinfection amount A 0_achieved does not increase during the period when the measured temperature of the liquid is below this threshold temperature TT.

[0153] 7 shows exemplary heating curves of the liquid temperature in the fluid circuit 100 as a function of elapsed time. Curve C1 represents the initial liquid temperature before the disinfection procedure begins (i.e., 60° C.). The heating of the liquid begins at time t0, which corresponds to the time when the control unit 500 activates the heating unit. Curve C2 represents the liquid temperature increase versus time that occurs between t0 and t3. In particular, the liquid temperature curve C2 represents the achieved disinfection amount A, preferably measured by a low temperature sensor in the fluid circuit. 0_achievedIn particular, the fact that the liquid temperature of curve C2 of FIG. 7 does not reach a flat, constant maximum temperature is not a limitation of the present disclosure. In fact, during the thermal disinfection procedure, the liquid measured temperature clearly reaches a plateau temperature (level C5) and may be maintained until the thermal disinfection procedure is completed. The plateau temperature is determined by controlling the maximum temperature of the liquid at the outlet of the heating unit and is equal to or greater than the maximum fixed temperature T fluid_set This is due to the fact that the

[0154] Curve C6 represents the threshold temperature value TT. When the liquid temperature curve C2 reaches the threshold temperature value TT at time t1, the disinfection treatment achieves a disinfection amount A 0_achieved Start calculating the achieved disinfection amount A 0_achieved The calculation of the achieved disinfection amount A is performed between t1 and t3. Conversely, between t0 and t1, 0_achieved is not calculated. Level C5 is the maximum temperature reached by the liquid 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 that represented by curve C2. Curve C3 shows the drop in liquid temperature that occurs when the thermal disinfection procedure is finished, in particular when the control unit 500 turns off the heating unit.

[0155] The thermal disinfection procedure of the fluid circuit 100 further includes operating the pumps 120, 122, 450 during the thermal disinfection procedure to determine the flow of the heated liquid in the fluid circuit 100. The thermal disinfection procedure may include connecting a shunt tube 132a between the dialysate supply outlet 130 and the dialysate return inlet 133 to exclude the dialyzer from the fluid circuit to be disinfected. In addition to this, the fluid circuit 100 may be configurable in a loop circuit for recirculation of the heated liquid, at least during the disinfection procedure. In accordance with the circuit described above, the loop circuit may include 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 drain line 108, optionally one or more bypass lines 109, 109a fluidly connecting the dialysis supply line 107 to the dialysis drain line 108, and optionally a shunt tube 132a. The disinfection procedure may mean instructing one or more valves 102, 121, 123, 124, 125, 126 of the dialysis machine in an open or closed position to define this loop circuit for recirculation of the heated liquid. The term loop circuit means a path along which the same heated liquid circulates to perform the disinfection procedure. In a further implementation, the control unit 500 may control the local air pressure value P atm , and may determine which of the various sterilization procedures is the most efficient sterilization procedure based on the maximum temperature achievable without boiling liquid into the lines. Indeed, the control unit 500 may receive the local air pressure values ​​P achievable thereby during a sterilization procedure. atm and / or (maximum) set temperature T fluid_set Based on this, the user may be provided (e.g., via a user interface) with information regarding the disinfection procedure that would take the least amount of time to perform. The user may select the proposed procedure or reject it and continue with a different procedure.

[0156] Generally, thermal disinfection procedures (more specifically, using the A0 concept) are preferred. However, it is also possible to use a thermal disinfection process under atmospheric conditions (and the required and desired disinfection level, e.g., A0, to be achieved). 0 setBased on the temperature selected for thermal disinfection (target value), the period to obtain thermal disinfection may be too long and chemical disinfection may be preferred. In other words, at the temperature selected for thermal disinfection, the system may estimate the time required to complete thermal disinfection (based on the liquid path design and empirical tests). The estimated time may be used as an indication for the user when to start thermal disinfection. From this indication, the user may decide to continue with thermal disinfection or select another type of disinfection to save time between treatments. At low temperatures, thermal disinfection may take too long to be considered efficient and chemical disinfection (with or without heat) may be a better choice.

[0157] The control unit 500 determines the set temperature T fluid_set Based on the estimated time to completion of the thermal disinfection procedure, T est Calculate the estimated time to complete the thermal disinfection procedure T est The reference time T ref and based on the comparison, the control unit 500 continues or recommends (on the user interface) the thermal disinfection treatment or starts another disinfection treatment, such as a chemical disinfection treatment. In particular, the reference time may be the time required for a different (e.g. chemical) disinfection with respect to the thermal disinfection. Thus, the different disinfection treatment requires less time to disinfect than the thermal disinfection treatment. In one example, the different disinfection treatment is a chemical disinfection using a chemical disinfectant such as NaOCl. Alternatively, a different disinfectant such as citric acid may be used.

[0158] Furthermore, the different disinfection procedures may also be based on heating liquids containing chemical agents (i.e. chemical disinfection and thermal disinfection). This would be advantageous if it shortens the disinfection time. It is also possible to configure the control unit so that the different disinfection procedures start automatically. In particular, the aforementioned steps of the thermal disinfection procedure may be performed by the control unit 500 of the blood treatment device 10 or the water purification device 300 or the peritoneal dialysis device. Alternatively, the control unit may be located remotely, such as a remote server, and configured to receive input data from the sensors and provide command signals to perform the treatment steps through a wired or wireless transmitter.

Claims

1. A thermal disinfection system (1) comprising a blood treatment device (10) with a fluid circuit (100) for liquid transport, said fluid circuit (100) comprising: 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 dialysate discharge line (108) extending from a dialysate return inlet (133) to a drain outlet (129), said dialysate return inlet (133) being adapted to connect to an outlet of said dialyzer (150); a heating unit (104) configured to heat a liquid in said fluid circuit (100); at least one temperature sensor (127, 127', 128) configured to provide a temperature signal representative of the temperature of a liquid in said fluid circuit (100); at least one pressure sensor (162) configured to provide a pressure signal representative of the local air pressure, The blood treatment device (10) comprises a control unit (500) configured to perform a thermal disinfection treatment of the fluid circuit (100), the thermal disinfection treatment comprising at least the following steps executed by the control unit (500): receiving the temperature signal from the at least one temperature sensor (127, 127', 128) and determining a measured temperature value (T fluid_mes ) determining - receiving said pressure signal from said at least one pressure sensor (162) and determining a measured local air pressure value (P atm ) determining - the measured temperature value (T fluid_mes ) and the measured local pressure value (P atm and driving the heating unit (104) to heat the liquid based on the temperature of the liquid; The control unit (500) when driving the heating unit (104) to heat the liquid based on the measured temperature value (T fluid_mes ) and the measured local air pressure value (P atm ) is determining a set temperature (T fluid_set ) of the liquid based on the measured local air pressure value (P atm ), said set temperature (T fluid_set ) being comprised between 50° C. and 105° C.; - controlling said heating unit (104) based on said measured temperature values ​​(Tfluid_mes) so as to heat said liquid up to but not exceeding said set temperature (Tfluid_set), The control unit (500) is configured to avoid boiling of the liquid in the fluid circuit (100) and maximize the set temperature (T fluid_set ) based on the measured local air pressure value (P atm ).

2. 2. A thermal disinfection system (1) according to claim 1, wherein the control unit (500) - A set disinfection amount (A) representing the required disinfection grade 0_set ) and - during said thermal disinfection treatment, the achieved disinfection amount (A 0_achieved ) and The thermal disinfection treatment is performed by 0_achieved ) to the set disinfection amount (A 0_set ) and based on the comparison, determining the achieved disinfection amount (A 0_achieved ) is the set disinfection amount (A 0_set ) or more, interrupting the thermal disinfection treatment; The set disinfection amount (A 0_set ) is between 200 and 1000, a thermal disinfection system (1).

3. A thermal disinfection system (1) according to claim 1, characterized in that the measured local air pressure value (P atm ) is determined by a predetermined relationship. fluid_set ), and the predetermined relationship relates to the measured local pressure value (P atm ) defines the boiling point temperature (BPT) as a function of 0.9 BPT < T fluid_set <BPT, Thermal Disinfection System (1).

4. A thermal disinfection system (1) according to claim 1 or 3, characterized in that the control unit (500) - the local air pressure (P atm ) continuously, periodically or randomly according to a predefined sample rate, said sample rate being comprised between 0.1 Hz and 500 Hz, and said control unit updates said local air pressure (P atm ) during the thermal disinfection procedure based on the updated measurements of the set temperature (T fluid_set ) and - during the initial stage of the thermal disinfection procedure or immediately before the start of the thermal disinfection procedure, the local air pressure (P atm ) and measuring the set temperature (T fluid_set ) is the measured local pressure value (P atm ) at the initial stage of the thermal disinfection procedure, and the set temperature (T fluid_set ) is kept constant during said thermal disinfection procedure.

5. A thermal disinfection system (1) according to claim 2, wherein the achieved disinfection amount (A 0_achieved The step of calculating the reference liquid temperature (T ref ) based on the reference liquid temperature (T ref ) is assumed to be the substantially lowest liquid temperature in the fluid circuit (100) during the thermal disinfection procedure; The achieved disinfection amount (A 0_achieved ) is a function of elapsed time.

6. A thermal disinfection system (1) according to claim 2 or 5, wherein the achieved disinfection amount (A 0_achieved ) is based on a predetermined z value defining a relationship between the liquid temperature and disinfection treatment effectiveness, the z value being comprised between 5° C. and 30° C.; The z-value corresponds to the increase in liquid temperature required to reduce the D-value of a microorganism by 90%, the D-value being the time required to kill 90% of a population of individual microorganisms at a given temperature.

7. A thermal disinfection system (1) according to any one of claims 2, 5 and 6, wherein the achieved disinfection amount (A 0_achieved ) is the following disinfection amount formula, It is calculated by z=10° C., Δt is the time interval in seconds between measurements by the at least one temperature sensor (127, 127′, 128) as controlled by the control unit (500), and T=T ref is the reference liquid temperature measured by said at least one temperature sensor (127, 127', 128) within said time interval Δt.

8. 8. A thermal disinfection system (1) according to any one of claims 1 to 7, wherein the fluid circuit (100) comprises at least one pump (120, 122) and a shunt tube (132a) connecting the dialysate supply outlet (130) to the dialysate return inlet (133) so as to bypass the dialyzer (150), and wherein the control unit (500) is configured to operate the at least one pump (120, 122) to determine the flow of the heated liquid in the fluid circuit (100) during the thermal disinfection procedure.

9. 9. The thermal disinfection system (1) according to claim 8, wherein the fluid circuit (100) is configurable into a loop circuit for recirculation of the heated liquid at least during the thermal disinfection procedure, the loop circuit being configured to control the heating unit (104), the at least one pump (120, 122), the at least one temperature sensor (127, 127', 128), at least a portion of the dialysis supply line (107), and at least a portion of the dialysis discharge line (108) and the control unit (106) to allow or prevent liquid passage therethrough, respectively. and one or more bypass lines (109, 109a) fluidly connecting the dialysis supply line (107) to the dialysis drain line (108), wherein the control unit (500) is further configured to command the one or more valves (102, 121, 123, 124, 125, 126) to define the loop circuit for recirculation of the heated liquid.

10. A thermal disinfection system (1) according to any one of the preceding claims, characterized in that the fluid circuit (100) comprises: a low temperature sensor (127') of the at least one temperature sensor (127, 127', 128) arranged upstream of the heating unit (104), the low temperature sensor (127') being arranged on the dialysis supply line (107) close to the inlet of the heating unit (104), the liquid temperature measured by the low temperature sensor (127') being assumed to be the lowest liquid temperature in the fluid circuit (100), and if the liquid flows in a loop circuit, the liquid temperature measured by the low temperature sensor (127') is equal to or lower than the reference temperature (T ref ), a low temperature sensor (127'); a return fluid temperature sensor (128) arranged on the dialysis discharge line (108) among the at least one temperature sensor (127, 127', 128), the return fluid temperature sensor (128) being arranged downstream of a return fluid pump (122) arranged on the dialysis discharge line (108) and as close as possible to the drain outlet (129), the liquid temperature measured by the return fluid temperature sensor (128) being equal to or greater than the reference temperature (T ref ), a returned liquid temperature sensor (128); a high temperature sensor (127) of the at least one temperature sensor (127, 127', 128) arranged downstream of the heating unit (104), the high temperature sensor (127) being arranged on the dialysis supply line (107) close to the outlet of the heating unit (104), the high temperature sensor (127) measuring the measured temperature value (T fluid_mes ), and the control unit (500) is configured to detect T fluid_mes = T fluid_set and a high temperature sensor (127) configured to control the heating unit (104) so ​​that

11. A thermal disinfection system (1) according to any one of claims 1 to 10, characterized in that the thermal disinfection treatment is carried out in a period of time A corresponding to a disinfection treatment period (DPt). 0_achieved ≧A 0_set and the control unit (500) is further configured to store the disinfection treatment duration (DPt) for the thermal disinfection treatment in a memory, and the control unit (500) determines a start time of a subsequent disinfection treatment based on the disinfection treatment duration (DPt) of a preceding disinfection treatment.

12. A thermal disinfection system (1) according to claim 5, wherein the control unit (500) is adapted to receive or store a threshold temperature value (TT) and to determine the achieved disinfection amount (A). 0_achieved The step of calculating the reference liquid temperature (T) begins when the measured temperature of the heated liquid is equal to or greater than the threshold temperature value (TT), and the measured temperature of the heated liquid is calculated based on the reference liquid temperature (T ref ) and The achieved disinfection amount (A 0_achieved ) is calculated based only on the period during which the measured temperature of the liquid exceeds the threshold temperature value (TT).

13. A thermal disinfection system (1) comprising a water purification device (300) with a fluid circuit connectable to a disposable set (40) of a peritoneal dialysis machine, said fluid circuit comprising: - an inlet port (399) for receiving water from a water source (398); a filtration unit comprising one or more water filters (160, 170, 180) configured to remove impurities from said water at least during a treatment session carried out by said peritoneal dialysis machine; a heating unit (302) configured to heat a liquid in said fluid circuit (100); at least one temperature sensor (303, 313, 323) configured to provide a temperature signal representative of the liquid temperature; at least one pressure sensor (362) configured to provide a pressure signal representative of the local air pressure, The water purification device (300) comprises a control unit (500) configured to perform a thermal disinfection treatment of the fluid circuit of the water purification device (300), the thermal disinfection treatment comprising at least the following steps executed by the control unit (500): receiving the temperature signal from the at least one temperature sensor (303, 313, 323) and determining a measured temperature value (T fluid_mes ) determining - receiving said pressure signal from said at least one pressure sensor (362) and determining a measured local air pressure value (P atm ) determining - the measured temperature value (T fluid_mes ) and the measured local pressure value (P atm and driving the heating unit (302) to heat the liquid based on the temperature of the liquid; The control unit (500) when driving the heating unit (104) to heat the liquid based on the measured temperature value (T fluid_mes ) and the measured local air pressure value (P atm ) is determining a set temperature (T fluid_set ) of the liquid based on the measured local air pressure value (P atm ), said set temperature (T fluid_set ) being comprised between 50° C. and 105° C.; - controlling said heating unit (104) based on said measured temperature values ​​(Tfluid_mes) so as to heat said liquid up to but not exceeding said set temperature (Tfluid_set), The control unit (500) is configured to avoid boiling of the liquid in the fluid circuit (100) and maximize the set temperature (T fluid_set ) based on the measured local air pressure value (P atm ).

14. A thermal disinfection system (1) including a peritoneal dialysis device with a fluid circuit (100) for liquid transport, said fluid circuit (100) comprising: at least one dialysate supply line extending from a dialysate inlet to a dialysate supply outlet adapted to transport fresh peritoneal dialysate directly or indirectly to a patient's catheter; a dialysis drain line extending from a spent peritoneal dialysis fluid inlet to a drain outlet, said spent peritoneal dialysis fluid inlet (133) being adapted to receive spent peritoneal dialysis fluid directly or indirectly from the patient's catheter; a heating unit (104) configured to heat a liquid in said fluid circuit (100); at least one temperature sensor (127, 127', 128) configured to provide a temperature signal representative of the temperature of a liquid in said fluid circuit (100); at least one pressure sensor (162) configured to provide a pressure signal representative of the local air pressure, The peritoneal dialysis device (10) comprises a control unit (500) configured to perform a thermal disinfection treatment of the fluid circuit (100), the thermal disinfection treatment comprising at least the following steps executed by the control unit (500): receiving the temperature signal from the at least one temperature sensor (127, 127', 128) and determining a measured temperature value (T fluid_mes ) determining - receiving said pressure signal from said at least one pressure sensor (162) and determining a measured local air pressure value (P atm ) determining - the measured temperature value (T fluid_mes ) and the measured local pressure value (P atm and driving the heating unit (104) to heat the liquid based on the temperature of the liquid; The control unit (500) when driving the heating unit (104) to heat the liquid based on the measured temperature value (T fluid_mes ) and the measured local air pressure value (P atm ) is determining a set temperature (T fluid_set ) of the liquid based on the measured local air pressure value (P atm ), said set temperature (T fluid_set ) being comprised between 50° C. and 105° C.; - controlling said heating unit (104) based on said measured temperature values ​​(Tfluid_mes) so as to heat said liquid up to but not exceeding said set temperature (Tfluid_set), The control unit (500) is configured to avoid boiling of the liquid in the fluid circuit (100) and maximize the set temperature (T fluid_set ) based on the measured local air pressure value (P atm ).

15. A thermal disinfection system (1) comprising a blood treatment device (10) with a fluid circuit (100) for liquid transport, said fluid circuit (100) comprising: 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 dialysate discharge line (108) extending from a dialysate return inlet (133) to a drain outlet (129), said dialysate return inlet (133) being adapted to connect to an outlet of said dialyzer (150); a heating unit (104) configured to heat a liquid in said fluid circuit (100); at least one temperature sensor (127, 127', 128) configured to provide a temperature signal representative of the temperature of a liquid in said fluid circuit (100); at least one pressure sensor (162) configured to provide a pressure signal representative of the local air pressure, The blood treatment device (10) comprises a control unit (500) configured to perform a thermal disinfection treatment of the fluid circuit (100), the thermal disinfection treatment comprising at least the following steps executed by the control unit (500): receiving the temperature signal from the at least one temperature sensor (127, 127', 128) and determining a measured temperature value (T fluid_mes ) determining - receiving said pressure signal from said at least one pressure sensor (162) and determining a measured local air pressure value (P atm ) determining the measured local air pressure value (P atm ) based on the set temperature (T fluid_set ) and determining the set temperature (T fluid_set ) is comprised between 70°C and 105°C; - the determined set temperature (T fluid_set ) based on the estimated time to completion of the thermal disinfection procedure (T est ) and - the estimated time to completion of the thermal disinfection procedure (T est ) to the reference time (T ref ) and - continuing the thermal disinfection treatment or recommending / initiating a different disinfection treatment based on the comparison result.

16. 16. The thermal disinfection system (1) according to claim 15, wherein the different disinfection treatment requires a shorter time for disinfection than the thermal disinfection treatment, and the different disinfection treatment is a chemical disinfection using a chemical disinfectant.

17. 17. The thermal disinfection system (1) according to claim 15 or 16, wherein the control unit (500) is configured to provide an indication on a user interface of the blood processing device (10) that the different disinfection procedure is recommended and to allow a user to accept or reject the different disinfection procedure.

18. A thermal disinfection system (1) comprising a blood treatment device (10) with a fluid circuit (100) for liquid transport, said fluid circuit (100) comprising: 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 dialysate discharge line (108) extending from a dialysate return inlet (133) to a drain outlet (129), said dialysate return inlet (133) being adapted to connect to an outlet of said dialyzer (150); a heating unit (104) configured to heat a liquid in said fluid circuit (100); at least one temperature sensor (127, 127', 128) configured to provide a temperature signal representative of the temperature of a liquid in said fluid circuit (100); at least one pressure sensor (162) configured to provide a pressure signal representative of the local air pressure, The blood treatment device (10) comprises a control unit (500) configured to perform a thermal disinfection treatment of the fluid circuit (100), the thermal disinfection treatment comprising at least the following steps executed by the control unit (500): receiving the temperature signal from the at least one temperature sensor (127, 127', 128) and determining a measured temperature value (T fluid_mes ) determining - receiving said pressure signal from said at least one pressure sensor (162) and determining a measured local air pressure value (P atm ) determining the measured local air pressure value (P atm ) based on the set temperature (T fluid_set ) and determining the set temperature (T fluid_set ) is comprised between 70°C and 105°C; - The liquid is heated to the set temperature (T fluid_set activating the heating unit (104) to heat the - A set disinfection amount (A) representing the required disinfection grade 0_set ) and receiving a threshold temperature value (TT); - the amount of disinfection achieved during the thermal disinfection treatment (A 0_achieved ) and calculating the achieved disinfection amount (A 0_achieved Calculating the temperature of the liquid based on the elapsed time (ΔT) and the reference liquid temperature (T ref ) and the reference liquid temperature (T ref ) is the substantially lowest liquid temperature in the fluid circuit (100) during the thermal disinfection treatment, and the achieved disinfection amount (A 0_achieved The step of calculating the reference liquid temperature (T ref ) is equal to or greater than said threshold temperature value (TT); -The above achieved disinfection amount (A 0_achieved ) to the set disinfection amount (A 0_set ) and based on said comparison, said achieved disinfection amount (A 0_achieved ) is the set disinfection amount (A 0_set ) or more, interrupting the thermal disinfection treatment.

19. A thermal disinfection system (1) according to claim 18, characterized in that the measured local air pressure value (P atm ) is determined by a predetermined relationship. fluid_set ), and the predetermined relationship relates to the measured local pressure value (P atm ) defines the boiling point temperature BPT as a function of 0.9 BPT < T fluid_set <BPT, Thermal Disinfection System (1).

20. A thermal disinfection system (1) according to claim 18 or 19, wherein the achieved disinfection amount (A 0_achieved ) is calculated based only on the period during which the measured temperature value of the liquid exceeds the threshold temperature value (TT).

21. A thermal disinfection system (1) according to any one of claims 18 to 20, characterized in that the control unit (500) is adapted to control the local air pressure (P atm ) continuously during the entire duration of the thermal disinfection procedure according to a predetermined sample rate, wherein the sample rate is comprised between 0.01 Hz and 1000 Hz.

22. A thermal disinfection system (1) according to claim 21, wherein the control unit is adapted to control the local air pressure (P atm ) during the thermal disinfection procedure based on the updated measurements of the set temperature (T fluid_set ).

23. A thermal disinfection system (1) according to any one of claims 1 to 22, wherein the thermal disinfection procedure comprises the following steps executed by the control unit (500): atm ) and the measured temperature value (T fluid_mes ) determining which disinfection treatment to apply from among a plurality of available disinfection treatments based on either or both of the following:

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