Methods, apparatuses, and system for disinfecting a medical device

Abstract

A disinfection system of a dialysis machine is disclosed herein. In an example, the disinfection system includes a connector compartment having a lid configured to cooperatively enclose at least a concentrate disposable connector coupled to a concentrate durable connector. An aperture in the connector compartment is configured to receive a portion of a disposable fluid line to create a fluid tight seal when the concentrate disposable connector is coupled to the concentrate durable connector and the lid is closed. The connector compartment also includes a first port fluidly coupled to a first portion of a disinfectant recirculation path and a second port fluidly coupled to a second portion of the disinfectant recirculation path to circulate heated disinfection fluid through the connector compartment. The heated disinfection fluid heats a concentrate located in the disposable fluid line for disinfecting an inside of a durable fluid line.

Description

METHODS, APPARATUSES, AND SYSTEM FOR DISINFECTING A MEDICAL DEVICETECHNICAL FIELD

[0001] The invention relates to a disinfection system configured to perform a thermal disinfection procedure in a medical device, such as a dialysis machine or a medical solution generation machine. In addition, the invention also relates to a disinfection system configured to perform a thermal disinfection procedure in a medical device.BACKGROUND

[0002] In treatment of patients suffering acute or chronic renal insufficiency, dialysis therapy is employed. Three general categories of dialysis therapy include hemodialysis (“HD”), peritoneal dialysis (“PD”), and continuous renal replacement therapy (“CRRT”). In some instances, a water purification apparatus provides purified water to a dialysis machine for treating the renal insufficiency.

[0003] In hemodialysis, a patient's blood is cleansed by blood passing through an artificial kidney in an extracorporeal membrane system, which is incorporated in a dialysis machine. The blood treatment involves extracorporeal circulation through an exchanger having a semipermeable membrane (e.g., a dialyzer) in which the patient's blood is circulated on one side of the membrane and a dialysis fluid, comprising the main electrolytes of the blood in concentrations close to those in the blood of a healthy subject, is circulated on the other side. Furthermore, a pressure difference is created between the two compartments of the dialyzer, which are delimited by the semipermeable membrane, so that a fraction of the plasma fluid passes by ultrafiltration through the membrane into the compartment containing the dialysis fluid.

[0004] CRRT is used as an alternative therapy for patients who are too ill or unstable for standard hemodialysis. It is similar to hemodialysis and makes use of a semipermeable membrane for diffusion and to some extent convection. It is, however, a slower form of blood treatment than hemodialysis, and may be continuously ongoing from a couple of hours up to several days.

[0005] In peritoneal dialysis, dialysis fluid is infused into a patient's peritoneal cavity. This cavity is lined by a peritoneal membrane, which is highly vascularized. Metabolites are removed from the patient's blood by diffusion across the peritoneal membrane into the dialysis fluid. Excess fluid (i.e., water) is also removed by osmosis induced by a hypertonic dialysis fluid. Through thesetwo processes, diffusion and osmotic ultrafiltration, appropriate quantities of solute metabolites and fluid need to be removed to maintain the patient's body fluid volumes and composition within appropriate limits.

[0006] There are various types of peritoneal dialysis therapies, including continuous ambulatory peritoneal dialysis (“CAPD”), automated peritoneal dialysis (“APD”), tidal flow APD, and continuous flow peritoneal dialysis (“CFPD”). CAPD is a manual dialysis treatment. The patient connects manually an implanted catheter to a drain, allowing spent dialysate fluid to drain from the peritoneal cavity. The patient then connects the catheter to a bag of fresh dialysis fluid, infusing fresh dialysis fluid through the catheter and into the patient. The patient disconnects the catheter from the fresh dialysis fluid bag and allows the dialysis fluid to dwell within the peritoneal cavity, where a transfer of waste, toxins, and excess water takes place.

[0007] APD is similar to CAPD in that the dialysis treatment includes drain, fill, and dwell cycles. APD machines, however, perform the cycles automatically, typically while a patient sleeps. APD machines free patients from having to manually perform the treatment cycles and from having to transport supplies during the day. APD machines connect fluidly to an implanted catheter, a source or bag of fresh dialysis fluid, and a fluid drain. APD machines pump fresh dialysis fluid from the dialysis fluid source, through the catheter, into the patient's peritoneal cavity. The APD machines then allow the dialysis fluid to dwell within the cavity to facilitate the transfer of waste, toxins, and excess water. APD machines pump spent dialysate from the peritoneal cavity, through the catheter, to the drain. As with the manual process of CAPD, several drain, fill and dwell cycles occur during APD. A "last fill" occurs often at the end of CAPD and APD, which remains in the peritoneal cavity of the patient until a next treatment.

[0008] Both CAPD and APD are batch type systems that send spent dialysis fluid to a drain. Tidal flow systems are modified batch systems. With tidal flow, instead of removing all the fluid from the patient over a longer period of time, a portion of the fluid is removed and replaced after smaller increments of time. Continuous flow or CFPD systems clean or regenerate spent dialysate instead of discarding the dialysate. CFPD systems are typically more complicated than batch systems.

[0009] CAPD, APD (including tidal flow), and CFPD systems can employ a pumping cassette. The pumping cassette typically includes a flexible membrane that is moved mechanically to push and pull dialysis fluid out of and into, respectively, the cassette. In one form of peritonealdialysis, an automated cycler is used to infuse and drain dialysis fluid. This form of treatment may be done automatically at night while a patient sleeps. The cycler measures the amount of fluid infused and the amount removed to compute a net fluid removal. The treatment sequence usually begins with an initial drain cycle to empty the peritoneal cavity of spent dialysate. The cycler then performs a series of fill, dwell, and drain cycles, typically finishing with a fill cycle.

[0010] Peritoneal dialysis generally requires large volumes of dialysis fluid. Generally, at each application or exchange, a given patient will infuse 2 to 3 liters of dialysis fluid into the peritoneal cavity. The dialysis fluid is allowed to dwell for approximately 1 to 3 hours, at which time it is drained out and exchanged for fresh dialysis fluid. Generally, four such exchanges are performed daily. Therefore, approximately 8 to 20 liters of dialysis fluid is required per day, 7 days a week, 365 days a year for each patient.

[0011] PD fluid is delivered directly to a patient’s peritoneal cavity. PD fluid therefore needs to have a level of sterilization suitable for being introduced into the patient’s peritoneum. PD dialysis fluid is accordingly premixed and sterilized typically prior to delivery to the location of use, usually the patient’s home.

[0012] Dialysis fluids, such as PD fluid, for use in the above-mentioned treatments, have traditionally been provided in sealed container bags, which are sterilized and ready for use. For example, peritoneal dialysis is typically performed using bags with three different concentrations of dextrose. The bags are delivered to a patient's home as 1 liter to 6 liter bags with different dextrose concentrations. A normal daily consumption is around 8 to 20 liters of PD dialysis fluid. The fluid is provided in sterilized bags of sizes up to six liters, which are packed into boxes and delivered, e.g., monthly, to a patient’s home. The boxes of fluid may be cumbersome and heavy for PD patients to handle and consume a substantial space in a room of their homes. The bags and boxes also produce a relatively large amount of waste that needs to be disposed on a weekly or monthly basis.

[0013] In light of above, several problems become apparent. Shipping and storage of the sheer volume of fluids required is space consuming. Additionally, the use of multiple prefilled bags produces waste materials in the form of empty containers and packaging. Sub-systems for an overall PD system that create dialysis solution at the point of use, e.g., at the PD machine are therefore needed.

[0014] An overall system for hemodialysis, PD, or CRRT, in some embodiments, include three primary components, namely a dialysis machine, a water purifier, and a disposable set operating with both the dialysis machine and the water purifier. The dialysis machine is e.g. a PD cycler, a hemodialysis machine, or a CRRT machine. The dialysis machine includes a solution generation device that prepares dialysis fluid from concentrates and purified water, which is received from the water purifier. The water purifier produces purified water from e.g. tap water, at the point of use. In some instances, the solution generation device is integrated with the water purifier instead of the dialysis machine or is a standalone device.

[0015] It is important that the dialysis machine, including the solution generation device, is kept sterilized or otherwise free of microbes and other containments. To achieve this, the dialysis machine must be frequently cleaned and disinfected. This is especially true for connectors and fluid lines that enter the dialysis machine, which oftentimes come in contact with a patient.

[0016] A need accordingly exists for a disinfection system for a medical device.SUMMARY

[0017] Example systems, methods, and apparatuses are disclosed herein for disinfecting external connectors and / or fluid lines of a medical device. The systems, methods, and apparatuses are configured to disinfect fluid lines and connectors that come into contact with a patient or other medical professional. The fluid lines and connectors may be for connecting concentrate containers to a solution generation device, which may be part of a dialysis machine, a water purifier, or configured as a separate device. The fluid lines and connectors may also include a patient line, a drain line, and / or a water line.

[0018] The systems, methods, and apparatuses comprise exchanging heat from a device disinfection fluid (e.g., a disinfection fluid), such as water, a disinfection solution, or citric acid, to concentrate contained inside of durable concentrate lines, concentrate connectors, and / or parts of disposable concentrate lines. The heated disinfection fluid is configured to disinfect outside surfaces of the durable concentrate lines, concentrate connectors, and / or parts of disposable concentrate lines that come into contact with a patient or other user. The heated concentrate is configured to disinfect inside surfaces of the durable concentrate lines, concentrate connectors, and / or parts of disposable concentrate lines. Disinfecting the outside and inside surfaces of the durable concentrate lines, concentrate connectors, and / or parts of disposable concentrate lineseffectively kills or neutralizes microbials that may originate from the concentrate itself, biofilm, or touch contamination.

[0019] The disinfection sequence disclosed herein may be performed before a dialysis treatment is performed to maintain microbial control. The disinfection sequence may also be performed after concentrate connectors are attached to the solution generation device. Further, when a patient line, drain line, and / or water line is configured as disclosed herein, the disinfection sequence may be performed after a patient or other user has contacted the patient line, drain line, or water line as part of a treatment setup.

[0020] The disinfection sequence is configured to consume relatively little concentrate so as to minimize the number of times a patient has to connect new concentrate containers. Additionally, the disinfection sequence disclosed herein uses concentrate for disinfection to reduce the number of times a patient or other user has to disconnect and re-connect connections to the concentrate containers, thereby reducing the risk of touch contamination. As such, it is an object of the disclosure to provide a solution generation device that is capable of cleaning itself to a microbial acceptable level at the point of care. It is a further object of the disclosure to provide methods for cleaning the solution generation device at the point of care. In detail, it is an object of the disclosure to provide a solution generation device and methods for cleaning the same that makes use of heat disinfection and an efficient use of a heating resource in the solution generation device for providing the heat disinfection.

[0021] In light of the disclosure herein and without limiting the disclosure in any way, in a first aspect of the present disclosure, which may be combined with any other aspect listed herein, a disinfection system of a solution generation device includes a disposable fluid line having a first end fluidly coupled to a concentrate container and a second end including a concentrate disposable connector and a durable fluid line having a first end including a concentrate durable connector. The concentrate durable connector is configured to be fluidly coupled to the concentrate disposable connector. The disinfection system also includes a connector compartment having a lid configured to cooperatively enclose at least the concentrate disposable connector coupled to the concentrate durable connector. An aperture in a wall of the connector compartment is configured to receive a portion of the disposable fluid line to create a fluid tight seal when the concentrate disposable connector is coupled to the concentrate durable connector and the lid is closed. The connector compartment includes a first port that is fluidly coupled to a first portion of a disinfectantrecirculation path and a second port fluidly coupled to a second portion of the disinfectant recirculation path.

[0022] In a second aspect of the present disclosure, which may be combined with any other aspect listed herein, the disinfectant recirculation path includes at least a heater to heat a disinfection fluid and a recirculation pump to push the disinfection fluid through the disinfectant recirculation path and through the connector compartment.

[0023] In a third aspect of the present disclosure, which may be combined with any other aspect listed herein, the disinfection system further includes a control unit communicatively coupled to the recirculation pump and the heater. The control unit is configured to cause the heater to heat the disinfection fluid and cause the recirculation pump to recirculate the disinfection fluid through the disinfectant recirculation path and through the connector compartment.

[0024] In a fourth aspect of the present disclosure, which may be combined with any other aspect listed herein, the disinfection system further includes a concentrate pump, where a second end of the durable fluid line is fluidly coupled to the concentrate pump. The control unit is communicatively coupled to the concentrate pump and configured to cause the concentrate pump to pump a fluid concentrate from the concentrate container through the disposable fluid line to the durable fluid line while causing the recirculation pump to recirculate the disinfection fluid through the disinfectant recirculation path.

[0025] In a fifth aspect of the present disclosure, which may be combined with any other aspect listed herein, the disinfection system further includes a sealing adaptor connected to a portion of the disposable fluid line between the first end and the second end. The aperture in the wall of the connector compartment is configured to receive the sealing adaptor to create the fluid tight seal when the concentrate disposable connector is coupled to the concentrate durable connector.

[0026] In a sixth aspect of the present disclosure, which may be combined with any other aspect listed herein, a disinfection system for a dialysis machine includes a disposable fluid line having a first end fluidly coupled to a concentrate container and a second end including a concentrate disposable connector and a durable fluid line having a first end including a concentrate durable connector. The concentrate durable connector is configured to be fluidly coupled to the concentrate disposable connector. The disinfection system further includes a housing comprising a connector compartment having a lid configured to cooperatively enclose at least the concentratedisposable connector coupled to the concentrate durable connector. An aperture in a wall of the connector compartment is configured to receive the disposable fluid line to create a fluid tight seal when the concentrate disposable connector is coupled to the concentrate durable connector and the lid is closed. The housing also includes a first disinfection line having a first end fluidly coupled to a first portion of a disinfectant recirculation path and a second end fluidly coupled to the connector compartment and a second disinfection line having a first end fluidly coupled to the connector compartment and a second end fluidly coupled to a second portion of the disinfectant recirculation path. At least a portion of the durable fluid line is enclosed within the second disinfection line.

[0027] In a seventh aspect of the present disclosure, which may be combined with any other aspect listed herein, the disinfection system further includes a sealing adaptor connected to a portion of the disposable fluid line between the first end and the second end. The aperture in the wall of the connector compartment is configured to receive the sealing adaptor to create the fluid tight seal when the concentrate disposable connector is coupled to the concentrate durable connector.

[0028] In an eighth aspect of the present disclosure, which may be combined with any other aspect listed herein, the disinfectant recirculation path includes at least a heater to heat a disinfection fluid and a recirculation pump to push the disinfection fluid through the disinfectant recirculation path and through the connector compartment.

[0029] In a ninth aspect of the present disclosure, which may be combined with any other aspect listed herein, the disinfection system further includes a control unit communicatively coupled to the recirculation pump and the heater. The control unit is configured to cause the heater to heat the disinfection fluid and cause the recirculation pump to recirculate the disinfection fluid through the disinfectant recirculation path and through the connector compartment.

[0030] In a tenth aspect of the present disclosure, which may be combined with any other aspect listed herein, the disinfection system further includes a concentrate pump, where a second end of the durable fluid line is fluidly coupled to the concentrate pump. The control unit is communicatively coupled to the concentrate pump and configured to cause the concentrate pump to pump a fluid concentrate from the concentrate container through the disposable fluid line to the durable fluid line while causing the recirculation pump to recirculate the disinfection fluid through the disinfectant recirculation path.

[0031] In an eleventh aspect of the present disclosure, which may be combined with any other aspect listed herein, the recirculation pump is configured to push the disinfection fluid through the first disinfection line to reach the connector compartment.

[0032] In a twelfth aspect of the present disclosure, which may be combined with any other aspect listed herein, the recirculation pump is configured to push the disinfection fluid through the second disinfection line to reach the connector compartment.

[0033] In a thirteenth aspect of the present disclosure, which may be combined with any other aspect listed herein, the disinfection fluid includes at least one of heated water, citric acid, or a disinfectant solution.

[0034] In a fourteenth aspect of the present disclosure, which may be combined with any other aspect listed herein, the dialysis machine is configured to receive water in the disinfectant recirculation path from a water purification apparatus.

[0035] In a fifteenth aspect of the present disclosure, which may be combined with any other aspect listed herein, the disinfection system further includes a temperature sensor located upstream from the heater along the disinfectant recirculation path. The temperature sensor is communicatively coupled to the control unit and configured to output a signal indicative of a temperature of the disinfection fluid upstream from the heater.

[0036] In a sixteenth aspect of the present disclosure, which may be combined with any other aspect listed herein, the control unit is configured to heat the disinfection fluid to a programmed temperature between 60°C and 105°C and recirculate the disinfection fluid through the disinfectant recirculation path for a time between 5 minutes and 30 minutes after detecting the temperature of the disinfection fluid has reached the programmed temperature.

[0037] In a seventeenth aspect of the present disclosure, which may be combined with any other aspect listed herein, the disinfection system further includes a sensor configured to sense when the lid is closed. The control unit is configured to cause the heater to heat the disinfection fluid and the recirculation pump to recirculate the disinfection fluid through the disinfectant recirculation path after receiving a signal from the sensor indicative that the lid is closed.

[0038] In an eighteenth aspect of the present disclosure, which may be combined with any other aspect listed herein, the first disinfection line includes an aperture. A portion of the durable fluid line forms a fluid tight seal at the aperture of the first disinfection line.

[0039] In a nineteenth aspect of the present disclosure, which may be combined with any other aspect listed herein, at least the second end of the durable fluid line is external from the first disinfection line.

[0040] In a twentieth aspect of the present disclosure, which may be combined with any other aspect listed herein, the first disinfection line and the durable fluid line comprise a dual lumen pipe.

[0041] In a twenty-first aspect of the present disclosure, which may be combined with any other aspect listed herein, the durable fluid line is an inner lumen of the dual lumen pipe and the first disinfection line is an outer lumen of the dual lumen pipe that surrounds the inner lumen.

[0042] In a twenty-second aspect of the present disclosure, which may be combined with any other aspect listed herein, the concentrate container includes an osmotic agent such as glucose, a buffer concentrate fluid, or an electrolyte concentrate.

[0043] In a twenty-third aspect of the present disclosure, which may be combined with any other aspect listed herein, the lid includes a tube seal configured to engage the sealing adaptor to form the fluid tight seal when the lid is closed.

[0044] In a twenty-fourth aspect of the present disclosure, which may be combined with any other aspect listed herein, the disinfection system further includes a second concentrate pump, a second disposable fluid line having a first end fluidly coupled to a second concentrate container and a second end including a second concentrate disposable connector, a second sealing adaptor connected to a portion of the second disposable fluid line between the first end and the second end, and a second durable fluid line having a first end including a second concentrate durable connector and a second end fluidly coupled to the second concentrate pump. The second concentrate durable connector is configured to be fluidly coupled to the second concentrate disposable connector. The connector compartment and the lid are further configured to cooperatively enclose at least the second concentrate disposable connector coupled to the second concentrate durable connector. A second aperture in the wall of the connector compartment is configured to receive the second sealing adaptor to create a fluid tight seal when the second concentrate disposable connector is coupled to the second concentrate durable connector and the lid is closed. Further, at least a portion of the second durable fluid line is enclosed within the second disinfection line.

[0045] In a twenty-fifth aspect of the present disclosure, which may be combined with any other aspect listed herein, the disinfection system further includes a temperature sensor locatedupstream from the heater along the disinfectant recirculation path. The temperature sensor is configured to output a signal indicative of a temperature of the disinfection fluid upstream from the heater. The disinfection system also includes a control unit communicatively coupled to the recirculation pump and the heater. The control unit is configured to (i) cause the heater to heat the disinfection fluid, (ii) cause the recirculation pump to recirculate the disinfection fluid through the disinfectant recirculation path including the first disinfection line and the second disinfection line, (iii) cause the concentrate pump to pump a fluid concentrate from the concentrate container through the durable fluid line, and (iv) cause the second concentrate pump to pump a second fluid concentrate from the second concentrate container through the second durable fluid line.

[0046] In a twenty-sixth aspect of the present disclosure, which may be combined with any other aspect listed herein, the control unit is configured to perform (i) and (ii) to cause the disinfection fluid to reach a predetermined temperature, and perform (iii) and (iv) while performing (i) and (ii) after the disinfection fluid has reached the predetermined temperature.

[0047] In a twenty-seventh aspect of the present disclosure, which may be combined with any other aspect listed herein, a disinfection method for a fluid generation machine is disclosed. The disinfection method is performed after a concentrate disposable connector of a disposable fluid line is fluidly coupled to a concentrate durable connector of a durable fluid line within a connector compartment having a lid configured to cooperatively enclose at least the concentrate disposable connector coupled to the concentrate durable connector. The disinfection method comprise (i) causing, via a control unit, a heater to warm a disinfection fluid within a disinfectant recirculation path, the connector compartment being a part of the disinfectant recirculation path, (ii) causing, via the control unit, a recirculation pump of the disinfectant recirculation path to recirculate the disinfection fluid through the disinfectant recirculation path including the connector compartment, and (iii) causing, via the control unit, a concentrate pump to pump a fluid concentrate from a concentrate container through the durable fluid line while performing (i) and (ii) to heat disinfect insides and outsides of at least a portion of the durable fluid line, the concentrate durable connector, and the concentrate disposable connector.

[0048] In a twenty-eighth aspect of the present disclosure, which may be combined with any other aspect listed herein, the disinfection method further includes receiving, in the control unit from a temperature sensor located along the disinfectant recirculation path, a signal indicative of a temperature of the disinfection fluid, performing, via the control unit, (i) and (ii) to cause thedisinfection fluid to reach a predetermined temperature, and performing, via the control unit, (iii) while performing (i) and (ii) after the disinfection fluid has reached the predetermined temperature.

[0049] In a twenty-ninth aspect of the present disclosure, which may be combined with any other aspect listed herein, the predetermined temperature is between 60°C and 105°C.

[0050] In a thirtieth aspect of the present disclosure, which may be combined with any other aspect listed herein, (iii) is performed while performing (i) and (ii) for at least 5 minutes.

[0051] In a thirty-first aspect of the present disclosure, which may be combined with any other aspect listed herein, the disinfection method further includes causing, via the control unit, the disinfection fluid to be sent to a drain after (iii).

[0052] In a thirty-second aspect of the present disclosure, which may be combined with any other aspect listed herein, the disinfection method further includes causing, via the control unit, at least some of the heated fluid concentrate to be sent to a drain after (iii).

[0053] In a thirty-third aspect of the present disclosure, which may be combined with any other aspect listed herein, the disinfection method further includes enabling, via the control unit, a dialysis treatment to be performed by the dialysis machine after (iii).

[0054] In a thirty-fourth aspect of the present disclosure, any of the structure and functionality disclosed in connection with Figs. 1 to 6 may be combined with any of the other structure and functionality disclosed in connection with Figs. 1 to 6.

[0055] In light of the present disclosure and the above aspects, it is therefore an advantage of the present disclosure to provide a disinfection system for disinfecting external fluid lines of a medical device, such as a dialysis machine and / or a fluid generation device. The dialysis machine is for example a peritoneal dialysis machine.

[0056] It is another advantage of the present disclosure to use heated disinfection fluid to heat a concentrate to simultaneously disinfect external and internal surfaces of fluid lines and connectors within a disinfection system of a medical device.

[0057] Additional features and advantages are described in, and will be apparent from, the following Detailed Description and the Figures. The features and advantages described herein are not all-inclusive and, in particular, many additional features and advantages will be apparent to one of ordinary skill in the art in view of the figures and description. Also, any particular embodiment does not have to have all of the advantages listed herein and it is expressly contemplated to claim individual advantageous embodiments separately. Moreover, it should benoted that the language used in the specification has been selected principally for readability and instructional purposes, and not to limit the scope of the inventive subject matter.BRIEF DESCRIPTION OF THE FIGURES

[0058] Fig. 1 is a diagram of a medical device with a disinfection system, such as a peritoneal dialysis machine, according to an example embodiment of the present disclosure.

[0059] Figs. 2 and 3 show enlarged views of a connector compartment of the disinfection system of Fig. 1, according to an example embodiment of the present disclosure.

[0060] Fig. 4 is a diagram that shows the disinfection apparatus of Fig. 1 without components from the medical device, according to an example embodiment of the present disclosure.

[0061] Fig. 5 is a diagram of a portion of the disinfection system in which the connector compartment and the second disinfection line is configured to disinfect fluid lines for two concentrate containers, according to an example embodiment of the present disclosure.

[0062] Fig. 6 is a flow diagram of an example procedure to perform a disinfection procedure using the disinfection system of Figs. 1 to 5, according to an example embodiment of the present disclosure.DETAILED DESCRIPTION

[0063] Methods, systems, and apparatuses are disclosed for disinfecting a medical device, such as a dialysis machine, a water purifier, and / or a solution generation device. In some embodiments, the dialysis machine is a peritoneal dialysis (“PD”) machine that includes a PD solution generation device. In other embodiments, solution generation device is a standalone device or integrated with a water purifier. As disclosed herein, the methods, systems, and apparatuses are configured to disinfect at least one concentrate line of a PD solution generation device while a respective concentrate container is affected and the at least one concentrate line is primed with concentrate. The methods, systems, and apparatuses may additionally be configured to disinfect a patient line, a drain line, and / or a water line. The methods, systems, and apparatuses are configured to flow a heated device disinfection fluid, such as water, citric acid, or a disinfection solution across an outside surface of the at least one concentrate line and corresponding connector(s). The heated device disinfection fluid transfers at least some heat to concentrate thatis primed within the at least one concentrate line. The heated concentrate is configured to disinfection inside surfaces of the at least one concentrate line and the corresponding connector(s). Together, the heated disinfection fluid and the concentrate disinfect outside and inside surfaces of the at least one concentrate line and the corresponding connector(s).

[0064] Using multi therapy concentrates and durable concentrate lines provides cost savings by reducing waste from disposable components and less container material per liter of concentrate. It also lowers a patient burden since unpacking, placing, and connecting the concentrate container can be performed with larger intervals than daily. The interval could be, for example, 7-14 days. As such, the example methods, systems, and apparatuses disclosed herein enables a multi therapy concentrate to remain attached to a PD solution generation device during heat disinfection. This provides an advantage of not having to disconnect and reconnect concentrates to perform disinfection (e.g., decreases patient burden, lowers the risk for touch contamination, and minimizes concentrate waste). This also provides efficient and effective disinfection of at least the concentrate lines and corresponding connectors from microbials that may originate from the concentrate(s), biofilm, touch contamination, or any other source.Medical Device with Disinfection Apparatus Embodiment

[0065] Fig. 1 is a diagram of a medical device 100, such as a peritoneal dialysis machine, according to an example embodiment of the present disclosure. The medical device 100 includes a solution generation device 101 for mixing concentrates with purified water to form dialysis fluid. The medical device 100 also includes a disinfection system 102 for reducing or eliminating microbials that may enter the medical device 100 through lines that bring concentrate into the medical device 100 for mixing. A housing 118 of the medical device 100 is configured to enclose the solution generation device 101, the disinfection system 102, and other components disclosed herein. The housing 118 may be formed of any composite or casing to prevent contaminants from entering the medical device.

[0066] In the illustrated example, the medical device 100 is connected to a first concentrate container 108a and a second concentrate container 108b. The first concentrate container 108a contains glucose and the second concentrate container 108b contains an electrolyte, such as sodium, potassium, calcium, magnesium, chloride, or bicarbonate. In some embodiments, the second concentrate container 108b is omitted. In yet other embodiments, additional concentratecontainers are connected to the medical device. For example, a citric acid container may be connected.

[0067] A disposable fluid line 106a and a durable fluid line 114a are used to fluidly couple the first concentrate container 108a to the medical device. The disposable fluid line 106a has a first end that is fluidly coupled to the first concentrate container 108a and a second end including a concentrate disposable connector 110a. The durable fluid line 114a has a first end comprising a concentrate durable connector 116a that mechanically and fluidly connects to the concentrate disposable connector 110a of the disposable fluid line 106a.

[0068] The concentrate durable connector 116a mechanically and fluidly connects to the concentrate disposable connector 110a within a connector compartment 120 of the housing 118. Fig. 2 shows an enlarged view of the connector compartment 120, according to an example embodiment of the present disclosure. In this example, the connector compartment 120 defines an internal area within which the concentrate durable connector 116a mechanically connects to the concentrate disposable connector 110a. As shown, the concentrate disposable connector 110a may screw into the concentrate durable connector 116a. However, it should be appreciated that any fluid-tight mechanical coupling may be made between the concentrate durable connector 116a and the concentrate disposable connector 110a.

[0069] As shown in Figs. 1 and 2, the durable fluid line 114a extends to a concentrate pump 104a within the medical device 100. A second end of the durable fluid line 114a fluidly couples to the concentrate pump 104a. In some embodiments, the concentrate pump 104a is a volumetric pump. Alternatively, the concentrate pump 104a may include a peristaltic pump, a piston pump, an elastomeric pump, etc. An output end of the concentrate pump 104a is fluidly coupled to a main line 103.

[0070] When the disposable fluid line 106a is connected to the durable fluid line 114a, the concentrate pump 104a is able to pull concentrate from the concentrate container 108a. The concentrate flows from the concentrate container 108a through the disposable fluid line 106a to the durable fluid line 114a and to the concentrate pump 104.

[0071] As shown in Fig. 3, the durable fluid line 114a is located within the housing 118 of the medical device 100. As such, it is not possible to remove the durable fluid line 114a without disassembling the medical device 100. To maintain microbial control, outside and inside surfaces of the disposable fluid line 106a, the concentrate disposable connector 110a, the durable fluid line114a, and the concentrate durable connector 116a must be disinfected. Further, while the disposable fluid line 106a may be discarded after a number of uses, the concentrate disposable connector 110a of the disposable fluid line 106a still needs to be disinfected when it is connected to the durable fluid line 114a. Otherwise, microbes and other containments from the concentrate disposable connector 110a may propagate along the concentrate disposable connector 110a and the concentrate durable connector 116a to the durable fluid line 114a and into the medical device 100.

[0072] Further, a patient or other user must manually connect the concentrate disposable connector 110a to the concentrate durable connector 116a. This exposes the outsides and possibly the insides of the connectors 110a and 116a to touch contamination. Further, ends of the durable fluid line 114a and the disposable fluid line 106a that are adjacent to the connectors 110a and 116a may experience touch contamination.

[0073] The connector compartment 120 is configured to enclose at least the concentrate disposable connector 110a and the concentrate durable connector 116a for disinfecting. As shown in Figs. 1 and 2, the connector compartment 120 may also enclose a portion of the disposable fluid line 106a that is adjacent to the concentrate disposable connector 110a. In addition, the connector compartment 120 encloses the durable fluid line 114a. As described in more detail below, the connector compartment 120 is configured to provide a fluid-tight seal to allow a heated disinfection fluid to disinfect exterior surfaces of the connectors 110a and 116a in addition to the durable fluid line 114a and portions of the disposable fluid line 106a contained within.

[0074] The connector compartment 120 may have a length between 4 centimeters (“cm”) and 12 cm, a width between 4 cm and 12 cm, and a depth 3 cm and 12 cm. The connector compartment 120 is configured to have an internal area sufficient for a patient to couple the connectors 110a and 116a together. While the connector compartment 120 is shown as having a rectangular shape, in other embodiments, the connector compartment 120 may have a rounded shape, like a bowl.

[0075] The connector compartment 120 includes a lid 122 that provides access to the concentrate durable connector (116a) when opened. The lid 122 may be connected to the housing 118 via a hinge. The hinge may include a spring that forces the lid 122 into a closed position.

[0076] To enable the disposable fluid line 106a to pass through for reaching the concentrate container 108a, the connector compartment 120 includes an aperture 202 or through hole locatedin one of its walls 204 that form a portion of the housing 118. The disposable fluid line 106a may create a fluid-tight seal with walls of the aperture 202 when inserted for use.

[0077] Alternatively, as shown in Figs. 2 and 3, a sealing adaptor 112a is connected to a portion of the disposable fluid line 106a between the first end and the second end. When inserted into the aperture 202, the sealing adaptor 112a creates a fluid tight seal to prevent heated disinfection fluid from leaking from the connector compartment 120. The sealing adaptor 112a may include a plastic, a composite, and / or an elastomeric sleeve.

[0078] To further prevent heated disinfection fluid from leaking, the connector compartment 120 may also include a seal 203. In some embodiments, the seal 203 is placed around an underside perimeter of the lid 122. When the lid 122 is closed, the seal 203 forms a fluid-tight closure with walls defining an opening in the connector compartment 120. In some embodiments, the seal 203 is configured to engage the sealing adapter 112a to form the fluid tight seal when the lid 122 is closed.

[0079] As shown in Figs. 1 and 2, the connector compartment 120 includes space between interior walls and exterior surfaces of the portion of the disposable fluid line 106a contained therein, the connectors 110a and 116a, and the durable fluid line 114a. The space is configured to receive heated disinfection fluid. A first disinfection line 124 has a first end that is fluidly coupled to a first portion of a disinfectant recirculation path 126 through which the heated disinfection fluid flows. A second end of the first disinfection line 124 is fluidly coupled to the connector compartment 120. As such, the first disinfection line 124 is an inlet for the heated disinfection fluid to the connector compartment 120.

[0080] A second disinfection line 128 is configured as an outlet for the heated disinfection fluid from the connector compartment 120. The second disinfection line 128 has a first end fluidly coupled to the connector compartment 120 and a second end fluidly coupled to a second portion of the disinfectant recirculation path 126. In some embodiments, at least a portion of the durable fluid line 114a is enclosed within the second disinfection line 128.

[0081] In some embodiments, the second disinfection line 128 may comprise a dual-lumen pipe. For example, the lumens may be concentric. When the lumens are concentric, the second disinfection line 128 is an exterior lumen and the durable fluid line 114a is an interior lumen. Such a configuration enables the heated disinfection fluid to flow around an exterior surface of the durable fluid line 114a.

[0082] In another embodiment, as shown in Fig. 2, the second disinfection line 128 includes an aperture 208 through which a portion of the durable fluid line 114a is routed. A portion of the durable fluid line 114a forms a fluid tight seal at the aperture 208 of the second disinfection line 128. In some instances, a sealing adapter may be connected to the second disinfection line 128 to provide a fluid tight seal with walls that define the aperture 208.

[0083] In the illustrated embodiment of Figs. 1 and 2, the second disinfection line 128 encloses the durable fluid line 114a. However, in other embodiments, the flow of the heated disinfection fluid may be reversed such that the first disinfection line 124 encloses the durable fluid line 114a. The flow direction of the heated disinfection fluid is less important than disinfecting the durable fluid line 114a, the portion of the disposable fluid line 106a contained within the connector compartment 120 and the connectors 110a and 116a.

[0084] In some embodiments, the lid 122 and / or the connector compartment 120 includes a sensor 206 that is configured to detect a position of the lid 122. The sensor 206 may include a contact sensor that detects when the lid 122 is opened or closed. Signals by the sensor 206 are used to ensure the lid is closed before disinfection fluid is pushed into the connector compartment 120.

[0085] Further, in some embodiments, the connector compartment 120 includes an ultraviolet (“UV”) light emitter configured to emit UV light. The UV light emitter is configured to be placed on the disposable fluid line 106a, the durable fluid line 114a, and / or one of the connectors 110a and 116a. UV light from the UV light emitter is configured to reduce or eliminate microbials. The UV light accordingly provides a UV barrier to prevent microbials from entering the medical device 100 and / or the disinfection system 102. In some embodiments, the UV light emitter is integrated with the sealing adapter 112a and / or provided in one of the interior walls of the connector compartment 120.

[0086] Returning to Fig. 1, the disinfectant recirculation path 126 is bolded for clarity. Disinfection fluid, such as water, citric acid, and / or a disinfection solution is added to the disinfectant recirculation path 126, the connector compartment 120, and a mixing chamber 138 during a priming operation. The mixing chamber 138 is for mixing dialysis fluid from water and concentrates, such as glucose and / or electrolytes. The mixing chamber 138 is located downstream from the heater 130 and the connector compartment 120.

[0087] The disinfection fluid is received from a source 139, such as a container or a water purification machine. In some embodiments, valves VEC1, VHD, and VMD (shown in Fig. 1) are closed to prevent the disinfection fluid from leaving the disinfectant recirculation path 126. Additionally, valves VRC, VWI, VCRD, and VEC2 are opened along the disinfectant recirculation path 126 to permit disinfection fluid to flow from the source 139 to the mixing chamber 138 through the first disinfection line 124, the connector compartment 120, and the second disinfection line 128 to the disinfectant recirculation path 126. As shown, the mixing chamber 138 is downstream from the second disinfection line 128. After a sufficient volume of disinfection fluid is aggregated in the mixing chamber, flow from the source 139 may be stopped. Further, three- way valves VST and VMC are actuated to cause the disinfection fluid to flow along the highlighted disinfectant recirculation path 126. Further, valve VMD is closed to prevent the disinfection fluid from flowing to a drain. Moreover, valves VRCD, VRC, and VWI are opened.

[0088] A pump 132 (e.g., a recirculation pump) is used to cause the disinfection fluid to flow through the disinfectant recirculation path 126. While the pump 132 is shown as being downstream from the mixing chamber 138, in other embodiments, the pump 132 is located upstream from the mixing chamber 138. The pump 132 is a volumetric pump. Alternatively, the pump 132 may include a peristaltic pump, a piston pump, an elastomeric pump, etc.

[0089] An inline heater is 130 is provided in the disinfectant recirculation path 126 to heat the disinfection fluid. The heater 130 is positioned downstream from the second disinfection line 128 and upstream from the mixing chamber 138. In other embodiments, the heater 130 is located downstream from the mixing chamber 138. The heater 130 may be a resistive heater. Alternatively, the heater 130 may be an inductive heater.

[0090] To heat the disinfection fluid, the pump 132 is configured to cause the disinfection fluid to loop through the disinfectant recirculation path 126 while the heater 130 is active. During disinfection, the disinfection fluid flows from the mixing chamber 138 through the pump 132 to the first disinfection line 124 and into the connector compartment 120. The disinfection fluid then flows through the second disinfection line 128 to the heater 130 and back into the mixing chamber 138. The disinfection fluid may be recirculated at a rate between 100 ml / minute to 500 ml / minute, preferably between 250 ml / minute to 350 ml, minute.

[0091] The heater 130 is configured to heat the disinfection fluid to a temperature between 65°C and 105°C, preferably between 85°C and 95°C. The disinfection system 102 includes at leastone temperature sensor 134, which is provided upstream from the heater 130. The temperature sensor 134 is configured to measure a temperature of the disinfection fluid. By being located upstream from the heater 130, the temperature sensor 134 measures a coldest point of the disinfectant recirculation path 126, which is approximately a temperature of the disinfection fluid within the connector compartment 120 and the second disinfection line 128. An output from the temperature sensor 134 is used for an Ao disinfection criteria calculation, which is described in more detail below. In some embodiments, a second temperature sensor T2 is located downstream from the heater 130. A difference in temperatures measured by the temperature sensor 134 and the temperature sensor T2 is indicative of a temperature drop of the disinfection fluid within the disinfectant recirculation path 126.

[0092] The heated disinfection fluid is configured to disinfect the inside of the connector compartment 120. This includes disinfection of exterior surfaces of the portion of the disposable fluid line 106a contained within the connector compartment 120, the connectors 110a and 116a, and the durable fluid line 114a. During disinfection, heat from the disinfection fluid transfers to concentrate located within the portion of the disposable fluid line 106a contained within the connector compartment 120, the connectors 110a and 116a, and the durable fluid line 114a.

[0093] The concentrate pump 104a is activated to slowly pump the concentrate from the concentrate container 108a through the disposable fluid line 106 to the durable fluid line 114a. The concentrate pump 104a may continue pumping until the concentrate reaches the pump 104a or the main line 103. The concentrate pump 104a may operate to cause the glucose concentrate from the container 108a to flow at a rate between 1 and 20 mL / minute, preferably between 1 and 5 mL / minute. The slow flow of the concentrate permits the concentrate to absorb sufficient heat (e.g., maximize conductive heat transfer from the disinfection fluid to the concentrate through fluid lines 106a and 114a and / or connectors 110a and 116a having certain materials, material thicknesses, and / or high surface-to-volume ratios that are conducive for transferring heat) to disinfect inside surfaces of the portion of the disposable fluid line 106a contained within the connector compartment 120, the connectors 110a and 116a, and the durable fluid line 114a. Accordingly, the exterior and interior surfaces of the portion of the disposable fluid line 106a contained within the connector compartment 120, the connectors 110a and 116a, and the durable fluid line 114a are disinfected using the disinfection system 102 disclosed herein.

[0094] To control the procedures disclosed herein, the medical device 100 includes a control unit 140. The example control unit 140 may include a microprocessor, a microcontroller, a logic controller, a processor, etc. The control unit 140 is communicatively coupled to a memory device 142, which may include flash memory, random-access memory, read-only memory, etc. The memory device 142 is configured to store computer-readable instructions 144. The control unit 140 is configured to execute the computer-readable instructions 144 to perform the operations described herein. For instance, the control unit 140 executes the computer-readable instructions 144 to perform the procedures disclosed herein.

[0095] The control unit 140 is configured to perform at least a disinfection procedure, a dialysis fluid preparation procedure, a priming procedure, and a treatment procedure. The disinfection procedure is discussed in further detail below in conjunction with Fig. 6. The dialysis fluid preparation procedure prepares dialysis fluid by mixing purified water with concentrate from the concentrate containers 108a and 108b. The priming procedure pushes air from fluid lines using the prepared dialysis fluid. The treatment procedure uses the dialysis fluid to perform one or more cycles of a peritoneal dialysis treatment.

[0096] To perform the procedures disclosed herein, the control unit 140 is configured to control actuation of the valves VEC1, VEC2, VWI, VHD, VRC, VMC, VST, VAI, VRCD, VMD, VUF1, VUF2, VBU, VUP, and VFO. The control unit 140 also controls operation of the concentrate pumps 104a and 104b and the recirculation pump 132. The control unit 140 is further configured to control the heater 130. In some embodiments, the control unit 140 may also control the flow of the disinfection fluid from the source 139.

[0097] For mixing water with concentrate, the control unit 140 is configured to receive signals from the temperature sensors 134 and T2 indicative of measured temperatures. The control unit 140 also receives a first measured conductivity value from conductivity sensor CondCl, a second measured conductivity value from conductivity probe CondP, and a third measured conductivity value from a conductivity sensor CondC2. The conductivity sensor CondCl and the conductivity probe CondP are provided downstream from the pump 132 and configured to measure a conductivity of a fluid passing through.

[0098] The conductivity values are used by the control unit 140 for preparing dialysis fluid by mixing water and the concentrates from the concentrate containers 108a and 108b. A conductivity value is indicative of a concentration of glucose and / or an electrolyte. To mix dialysisfluid, the control unit 140 operates the concentrate pumps 104a and 104b to mix concentrates with water from the source 139 while measuring the downstream conductivity until desired concentrations in the dialysis fluid are achieved. For instance, the control unit 140 may proportion each of the pumps 104a and 104b to incrementally control how much concentrate is mixed with water. The concentrate flows from the pumps 104a and 104b respectively to the main line 103 and into a preliminary mixing chamber PMC. The mixture of concentrates then contacts water at an outlet of the PMC and is pushed through the heater 130 and into the mixing chamber 138 for mixing to form dialysis fluid. After the dialysis fluid is prepared, the dialysis fluid is used for priming and treatment.

[0099] For the disinfection procedure disclosed herein, the values from the conductivity sensors CondCl and CondC2 in addition to the probe CondP may be discarded or otherwise ignored. Alternatively, the values from the conductivity sensor CondCl and the probe CondP may be used to detect if concentrate has begun mixing with the disinfection fluid, which may cause the control unit 140 to stop the disinfection procedure if too much concentrate mixes with the disinfection fluid. Alternatively, the control unit 140 may cause the concentrate pump 104a to stop pumping when concentrate is detected within the disinfection fluid. In these instances, the main line 103 becomes part of the disinfectant recirculation path 126.

[0100] The medical device 100 of Fig. 1 also includes other components that are used for priming and treatment but not for disinfection of the portion of the disposable fluid line 106a contained therein, the connectors 110a and 116a, and the durable fluid line 114a. These components include an air filter FA and ultrafilters UF. The air filter FA is configured to intake air to perform an ultrafilter integrity test. During a priming operation, the control unit may open valve VRCD while opening and closing valves VUF1, VUF2, and VBU to prime the ultrafilters UF. Either valve VFO or valve VMD is opened so that the fluid used for priming the ultrafilters pushes any air to the drain. The ultrafilters UF are configured to remove particles from dialysis fluid, such as bacteria and endotoxins. Conductivity sensor CondC2 measures a conductivity of the dialysis fluid after passing through the ultrafilters UF.

[0101] An output from the ultrafilters UF leads to a port PF, which may be fluidly coupled to PD cycler. Fresh dialysis fluid is routed from the pump 132 through ultrafilters UF and the PD cycler for providing to a patient’s peritoneal cavity. The medical device 100 also includes a port PD, which may be fluidly coupled to the drain.

[0102] The medical device 100 also includes pressure sensors Pl, P2, and P3. Pressure sensor Pl is located upstream from the port PF and outputs a pressure signal to the control unit 140 that is indicative of a pressure of dialysis fluid being provided to the PD cycler. The control unit 140 is configured to stop pumping dialysis fluid to the PD cycler when the signal from the pressure sensor Pl exceeds a threshold. The output from the pressure sensor Pl may also provide control for the cycler.

[0103] The pressure sensor P2 is located along the main line 103 downstream from the concentrate pumps 104a and 104b. An output signal from the pressure sensor P2 is used for dosing point pressure control during mixing and for heater pressure control during disinfection. The pressure sensor P3 is located downstream from the pump 132. Signals from the pressure sensor P3 are used by the control unit 140 to ensure the pump 132 is operating as intended. Recorded pressure spikes by the pressure sensor P3 may be indicative of a downstream occlusion.Disinfection System Embodiment

[0104] In some embodiments, the disinfection system 102 may include fewer components. Fig. 4 is a diagram that shows the disinfection system 102 of Fig. 1 without some components from the medical device 100 of Fig. 1, according to an example embodiment of the present disclosure.

[0105] The disinfection system 102 includes the connector compartment 120 disclosed in conjunction with Figs. 1 to 3. As shown in Fig. 4, the connector compartment 120 receives the disposable fluid line 106a, which terminates at the concentrate disposable connector 110a. The connector compartment 120 also receives the durable fluid line 114a, which terminates at the concentrate durable connector 116a. The connectors 110a and 116a are fluidly connected within the connector compartment 120.

[0106] Similar to Fig. 1, the disinfection system 102 of Fig. 4 includes the disinfectant recirculation path 126, which fluidly couples to the connector compartment 120 via a first port 402 and a second port 404. As shown, the connector compartment 120 encloses at least a portion of the durable fluid line 114a. The disinfection fluid source 139 is fluidly coupled to the disinfectant recirculation path 126 to provide the disinfection fluid. The heater 130, the mixing chamber 138, and the pump 132 are located along the disinfectant recirculation path 126.

[0107] The control unit 140 executes the instructions 144 stored in the memory device 142 to cause the disinfection fluid to fill the mixing chamber 138 and prime the connector compartment 120 and the disinfectant recirculation path 126. The control unit 140 then causes the heater 130 to warm the disinfection fluid to a programmed temperature while operating the pump 132. The temperature sensor 134 is located upstream from the heater 130 and transmits signals to the control unit 140 that are indicative of the temperature of the disinfection fluid within the connector compartment 120.

[0108] After the temperature reaches the programmed temperature, the control unit 140 continues to cause the pump 132 to move the disinfection fluid through the connector compartment 120 and the disinfectant recirculation path 126 while using feedback control from at least the temperature sensor 134 to maintain the programmed temperature. The control unit 140 also causes the concentrate pump 104a to pump the glucose concentrate from the container 108a through the disposable fluid line 106a and through the connectors 110a to 116a to the durable fluid line 114a. The speed of the concentrate pump 104a is slower than the pump 132 to reduce the amount of concentrate that is consumed for disinfection. In some instance, the pump 132 may pump the disinfection fluid at a rate of 300 mL / minute while the concentrate pump 104a operates at 1 to 5 mL per minute.

[0109] Heat from the disinfection fluid within the connector compartment 120 and the second disinfection line 128 transfers to the concentrate within the portion of the disposable fluid line 106a that is within the connector compartment 120, the connectors 110a and 116b, and the durable fluid line 114a. After some time, sufficient heat has transferred from the disinfection fluid to the concentrate such that the concentrate acts as a disinfectant. The control unit 140 is configured to cause the heated concentrate to disinfect, for a programmed time period or until a certain heat dose has been delivered, as discussed in more detail below, inside surfaces of the portion of the disposable fluid line 106a that is within the connector compartment 120, the connectors 110a and 116a, and the durable fluid line 114a. At the same time, the heated disinfection fluid disinfects, for the programmed time period, outside surfaces of the portion of the disposable fluid line 106a that is within the connector compartment 120, the connectors 110a and 116a, and the durable fluid line 114a. Accordingly, the control unit 140 causes outside and internal surfaces of fluid lines and corresponding connectors to be disinfected before dialysis fluid isprepared for treatment, thereby reducing or eliminating microbials that could enter the disinfection system 102 through fluid lines that have been contaminated by handling from a user.Multiple Fluid Line Embodiment

[0110] Figs. 1 to 4 are described in conjunction with the disinfection system 102 being configured to disinfect fluid lines for a single concentrate. It should be appreciated that the disinfection system 102 disclosed herein may be configured to disinfect more than one fluid line. Fig. 5 is a diagram of a portion of the disinfection system 102 in which the connector compartment 120 and the second disinfection line 128 is configured to disinfect fluid lines for two concentrate containers 108a and 108b, according to an example embodiment of the present disclosure.

[0111] In the illustrated example, the disposable fluid line 106a is fluidly coupled to the concentrate container 108a while a disposable fluid line 106b is fluid coupled to the concentrate container 108b. Portions of the disposable fluid lines 106a and 106b are routed into the connector compartment 120 via one or more apertures 202. Each of the disposable fluid lines 106a and 106b may include sealing adapters 112a and 112b to engage the respective apertures 202 of the connector compartment 120 to create fluid-tight seals.

[0112] Each of the disposable fluid lines 106a and 106b have ends connected to respective concentrate disposable connectors 110a and 110b, which are connected to concentrate durable connectors 116a and 116b. In some embodiments, the connectors 110a and 116a include a first key or tab-locks while the connectors 110b and 116b include second key or tab-locks. The use of the different keys or tab-locks prevents the disposable fluid lines 106a and 106b from being improperly connected to the wrong durable fluid lines 114a and 114b. In other embodiments, the key or tab-locks are omitted.

[0113] As shown in Fig. 5, the durable fluid lines 114a and 114b are connected to respective concentrate pumps 104a and 104b. The second disinfection line 128 includes apertures 208 and 502 to respectively permit portions of the durable fluid lines 114a and 114b to connect to the concentrate pumps 104a and 104b. In some embodiments, ends of the durable fluid lines 114a and 114b include connectors 504a and 504b for fluidly coupling to the concentrate pumps 104a and 104b through the apertures 202 and 502. Alternatively, the connectors 504a and 504b may be ports that provide a fluid coupling between the durable fluid lines 114a and 114b and the respectiveconcentrate pumps 104a and 104b. Each of the concentrate pumps 104a and 104b output to the main line 103.

[0114] The disinfection system 102 of Fig. 5 operates in a similar manner as the disinfection system 102 of Figs. 1 to 4. Heated disinfection fluid enters the connector compartment 120 via the first disinfection line 124 after the lid 122 is closed to create a fluid-tight seal. The heated disinfection fluid exits the connector compartment 120 via the second disinfection line 128. The heated disinfection fluid disinfects outside surfaces of the portions of the disposable fluid lines 106a and 106b that are within the connector compartment 120, the connectors 110a, 110b, 116a, and 116b, and the durable fluid lines 114a and 114b. Since both of the durable fluid lines 114a and 114b are contained within the second disinfection line 128, the heated disinfection fluid is able to disinfect both lines 114a and 114b at the same time. In addition, heat transfer between the disinfection fluid and concentrates within the respective lines 106a, 106b, 114a, and 114b and connectors 110a, 110b, 116a, and 116b causes the concentrate to heat, thereby disinfecting inside surfaces of the portions of the disposable fluid lines 106a and 106b that are within the connector compartment 120, the connectors 110a, 110b, 116a, and 116b, and the durable fluid lines 114a and 114b.Disinfection Procedure Embodiment

[0115] Fig. 6 is a flow diagram of an example procedure 600 to perform a disinfection procedure using the disinfection system 102 of Figs. 1 to 5, according to an example embodiment of the present disclosure. Although the procedure 600 is described with reference to the flow diagram illustrated in Fig. 6, it should be appreciated that many other methods of performing the steps associated with the procedure 600 may be used. For example, the order of many of the blocks may be changed, certain blocks may be combined with other blocks, and many of the blocks described may be optional. For example, steps for adding a disinfection fluid to the disinfection system 102 may be added. The operations described in the procedure 600 are specified by one or more of the instructions 144 and may be performed among the control unit 140, and the disinfection system 102 more generally.

[0116] The example procedure 600 is described for embodiments where a single concentrate connection is disinfected. The procedure 600 is similar when there are two or more connections for disinfection. The example procedure 600 begins when the control unit 140receives an indication message 601 that the concentrate durable connector 116a is fluidly coupled to the concentrate disposable connector 110a (block 602). The indication message 601 may be received via a user interface that is operable with the control unit 140. For instance, the user interface may include a display screen of the medical device 100 and / or the disinfection system 102. The user interface may also include a smartphone or tablet computer that is communicatively coupled to the control unit 140 via a direct or network connection.

[0117] In an embodiment, the user interface may display step-by-step instructions for performing the disinfection procedure disclosed herein. For a first step, the user interface may instruct a user to obtain the concentrate container 108a. For a second step, the user interface may instruct the user to connect the concentrate container 108a to the disposable fluid line 106a. Alternatively, the concentrate container 108a is pre-connected to the disposable fluid line 106a or the concentrate container 108a and the disposable fluid line 106a are formed as a single component and this step is omitted. For a third step, the user interface may instruct the user to connect the concentrate disposable connector 110a of the disposable fluid line 106a to the concentrate durable connector 116a located within the connector compartment 120. To confirm that the user has performed each step, the user interface may include a ‘confirm’ icon or button to provide, for example, the indication message 601 to the control unit 140. The step-by-step instructions may include text in addition to graphics, an animation, and / or video showing the user how to perform the step.

[0118] Returning to Fig. 6, the control unit 140 next receives an indication message 603 that the user has closed the lid 122 to create a fluid-tight seal in the connector compartment 120 (block 604). In some embodiments, the control unit 140 may also receive an indication that the sealing adapter 112a of the disposable fluid line 106a has been placed in the aperture 202 to create a fluid-tight seal. The control unit 140 next receives an indication message 605 that specifies disinfection can begin. In some embodiments, the control unit 140 may cause the mixing chamber 138 to fill to a certain volume with a disinfection fluid from the fluid source 139, which may be part of priming the medical device 100. The control unit 140 may further actuate one more valves and / or cause the pump 132 to fill the disinfection recirculation path 126 and / or the connector compartment 120 with disinfection fluid.

[0119] The control unit 140 then receives one or more signals 607 from the temperature sensor 134 that are indicative of a temperature of the disinfection fluid within theconnector compartment 120 (block 608). The control unit 140 causes the pump 132 to operate by sending one or more signals and / or messages 609, which indicates a programmed flow rate or pump speed. In addition, the control unit 140 transmits one or more messages or signals 611 to the heater 130 to warm the disinfection fluid to a programmed (e.g., predetermined) temperature (block 612). The control unit 140 then performs a feedback loop using the one or more signals 607 from the temperature sensor 134 to ensure the disinfection fluid is warmed to the programmed temperature while the pump 132 is operating. The programmed temperature is a temperature between 65°C and 105°C.

[0120] After the temperature has reached the programmed temperature, the control unit 140 causes the concentrate pump 104a to begin pumping concentrate through the disposable fluid line 106a to the durable fluid line 114a by sending one or more control signals 615 (block 616). The control unit 140 maintains this state for a specified time period based on the programmed temperature of the disinfection fluid. The specified time period is at least 5 minutes. During this time, the heated disinfection fluid disinfects outside surfaces of the portion of the disposable fluid line 106a contained in the connector compartment 120, the connectors 110a and 116a, and the durable fluid line 114a. Further, heat from the disinfection fluid transfers to the concentrate for disinfecting inside surfaces of the portion of the disposable fluid line 106a contained in the connector compartment 120, the connectors 110a and 116a, and the durable fluid line 114a. In some embodiments, the control unit 140 is configured to send one or more control signals to stop the concentrate pump 104a from pumping after the concentrate has reached the pump 104a. The control unit 140 causes the concentrate pump 104a to stop pumping for a defined time period, such as 5 minutes or 10 minutes, to allow the temperature to equalize between the inside and outsides of the disposable fluid line 106a contained in the connector compartment 120, the connectors 110a and 116a, and the durable fluid line 114a.

[0121] After the specified time period has elapsed, the control unit 140 may cause the disinfection fluid and / or the concentrate to be pumped to drain by sending one or more control signals 617 (block 618). Some control signals 617 may cause valve VMD to open while causing the pump 132 to push the disinfection fluid to drain. In some instances, the control unit 140 may cause cold disinfection fluid from the source 139 to push the heated disinfection fluid to the drain and / or cool the connector compartment 120 including the portion of the disposable fluid line 106a contained in the connector compartment 120, the connectors 110a and 116a, and the durable fluidline 114a. Further, after the connector compartment 120 has cooled, some of the control signals 617 may cause the concentrate pump 104a to pump a certain amount of concentrate to push the heated concentrate to drain.

[0122] The example control unit 140 next enables a peritoneal dialysis treatment to be performed (block 620). This may include preparing dialysis fluid in the medical device 100 by mixing water from the source 139 with one or more concentrates. This may also include warming the mixed dialysis fluid to a patient temperature. This may further include performing one or more fill, dwell, and drain cycles with the prepared dialysis fluid using the medical device 100.Heat Disinfection Embodiment

[0123] As discussed above, the disinfection system 102 is configured to provide a heat dose Ao for disinfection. The heat dose Ao is based on a temperature of the disinfection fluid and a time duration upon which the heated disinfection fluid is in contact with surfaces to be disinfected. The control unit 140 may be programmed to use an Ao value of 600, for example. In this instance, a disinfection time duration of 5 minutes is sufficient to reach an Ao vale of 600 when the temperature of the disinfection fluid is 83°C.

[0124] The disinfection procedure disclosed herein comprises determining a set temperature Tfiuid set of the disinfection fluid, where this set temperature Tfiuid set is between 65°C and 105°C, preferably between 70°C and 100°C. Thus, the disinfection procedure comprises controlling the heater 130 based on the measured temperature value Tfiuid mes to heat the disinfection fluid up to, and preferably not beyond, the set temperature T fluid set.

[0125] The disinfection procedure may be achieved through an “Ao” method, which uses knowledge of the lethality of the particular process at different temperatures to assess the overall lethality of the cycle and express this as the equivalent exposure time at a specified temperature. The term “H”, also referred as the disinfection dose, is defined as the equivalent time in seconds at 80°C that generates a certain disinfection action against microorganisms with a defined “z” value, where the “z” value is a measurement, expressed in °C, of the temperature relationship to the killing process. Based on the definition, the “z” value corresponds to the increase in temperature required to reduce a “D” value of a particular microorganism by 90%: the “D” value is the time required at a given temperature to kill 90% of a population of the respective microorganisms (i.e., the decimal reduction time). The “z” value of a microorganism thusincreases in tandem with growing resistance of this organism. Bacterial spores, which are the most resistant of all microorganism, have an average value of z = 10°C. This z value is also employed in the “Ao” concept. Selection of the “z” value is a safety reserve when defining disinfection parameters. In the case of z = 10°C, the term “Ao” is used instead of “A”. A given “Ao” value can be achieved with the most diverse temperature / time combinations.

[0126] The mathematic formula for calculation of Ao is as follows:

[0127]

[0128]

[0129] where “Ao” is the “A” value when z = 10°C; At is the chosen time interval in seconds; T is the disinfection fluid temperature in °C measured at the time “t”. A lower temperature limit for the integration is set at 65°C. Consequently, Ao is a time related unit, which is dependent on temperature. As an example, Ao= 600 may be achieved by 10 min at 80°C, or by 1 min at 90°C or by 100 min at 70°C. For sterilization of medical devices, values of Ao comprised between 600 and 3000 may be used. However, lower or higher values of Ao may be set.

[0130] In the case wherein the disinfection fluid temperature is constant (“Tconstant”) along the whole disinfection procedure, the disinfection dose Ao may be calculated by the following formula:

[0131] where “Ao” is the “A” value when z = 10°C; tprOc is the time duration of the disinfection procedure; and Tconstant is the disinfection fluid temperature in °C maintained during the whole disinfection process.

[0132] Based on the above description, the thermal disinfection procedure further comprises the steps of receiving a set disinfection dose Ao set representative of a disinfection grade required in the control unit 140, and calculating, during the disinfection procedure, an achieved disinfection dose Ao achieved. In particular, the disinfection procedure comprises comparing the achieved disinfection dose Ao achieved with a set disinfection dose Ao set and, based on this comparison, discontinue the disinfection procedure when the achieved disinfection dose Ao achieved equals or exceeds the set disinfection dose Ao set. The set disinfection dose Ao set may be between 40 and 2000, in particular between 200 and 1000, more in particular between 500 and 700. Notably,the calculating step of the achieved disinfection dose Ao achieved is based on a reference disinfection fluid temperature Tref (namely the fluid temperature T in °C measured at the time “f ’ referred to in equations 1 and 2 reported above) measured by the at least one temperature sensor 134, where the reference fluid temperature Tref is assumed to be substantially the lowest fluid temperature within the disinfection recirculation path 126 and the connector compartment 120 during the thermal disinfection procedure for safety reasons. Therefore, during the disinfection procedure, the temperature sensor 134 is configured to detect the fluid temperature value TflUid_mes of the disinfection fluid and the control unit 140 is configured to control the heater 130 so that Tfluid mes Tfluid set- In particular the control unit 140 is configured, during the disinfection procedure, to control heating power or energy provided by the heating 130 to the disinfection fluid to reach the desired fluid temperature Tnlud set. The heating power is controlled by varying the electric energy provided.

[0133] The disinfection procedure is completed when AO achieved> AO setcorresponding to a disinfection procedure time period DPt. The disinfection procedure comprises the step of storing in the memory device 142 this time period DPt relative to the completed disinfection procedure. Subsequently, the control unit 140 is configured to determine the starting time of a subsequent disinfection procedure based on this time period DPt of the preceding disinfection procedure. The thermal disinfection procedure may also comprise a step of receiving or storing a threshold temperature value TT, such that the step of the disinfection procedure of calculating the achieved disinfection dose Ao achieved starts when a measured temperature of the heated disinfection fluid equals or exceeds said threshold temperature value TT: in particular, this measured temperature of the heated fluid is the fluid reference temperature Tref. The achieved disinfection dose Ao achieved is computed only based on time periods when the measured temperature of the fluid exceeds this threshold temperature value TT. On the contrary, during time periods when the measured temperature of the fluid is lower than this threshold temperature value TT, the achieved disinfection dose Ao achieved is not computed. In other words, the achieved disinfection dose Ao achieved does not increment during time periods wherein the measured temperature of the fluid is lower than this threshold temperature value TT.Conclusion

[0134] It should be understood that various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the present subject matter and without diminishing its intended advantages. It is therefore intended that such changes and modifications be covered by the appended claims.

Claims

CLAIMSClaim 1 : A disinfection system (102) of a solution generation device (100), the disinfection system comprising: a disposable fluid line (106a) having a first end fluidly coupled to a concentrate container (108a) and a second end including a concentrate disposable connector (110a); a durable fluid line (114a) having a first end including a concentrate durable connector (116a), the concentrate durable connector (116a) configured to be fluidly coupled to the concentrate disposable connector (110a); and a connector compartment (120) having a lid (122) configured to cooperatively enclose at least the concentrate disposable connector (110a) coupled to the concentrate durable connector (116a), an aperture (202) in a wall of the connector compartment (120) configured to receive a portion of the disposable fluid line (106a) to create a fluid tight seal when the concentrate disposable connector (110a) is coupled to the concentrate durable connector (116a) and the lid (122) is closed, the connector compartment (120) including a first port (402) fluidly coupled to a first portion of a disinfectant recirculation path (126) and a second port (404) fluidly coupled to a second portion of the disinfectant recirculation path.Claim 2: The disinfection system of Claim 1, wherein the disinfectant recirculation path (126) includes at least a heater (130) to heat a disinfection fluid and a recirculation pump (132) to push the disinfection fluid through the disinfectant recirculation path and through the connector compartment (120).Claim 3: The disinfection system of Claim 2, further comprising a control unit (140) communicatively coupled to the recirculation pump (132) and the heater (130), the control unit configured to: cause the heater (130) to heat the disinfection fluid; and cause the recirculation pump (132) to recirculate the disinfection fluid through the disinfectant recirculation path (126) and through the connector compartment (120).Claim 4: The disinfection system of Claim 3, further comprising a concentrate pump(104a), wherein a second end of the durable fluid line (114a) is fluidly coupled to the concentrate pump, and wherein the control unit (140) is communicatively coupled to the concentrate pump (104a) and configured to cause the concentrate pump (104a) to pump a fluid concentrate from the concentrate container (108a) through the disposable fluid line (106a) to the durable fluid line (114a) while causing the recirculation pump (132) to recirculate the disinfection fluid through the disinfectant recirculation path (126).Claim 5: The disinfection system of Claims 1 or 4, further comprising a sealing adaptor (112a) connected to a portion of the disposable fluid line (106a) between the first end and the second end, wherein the aperture (202) in the wall of the connector compartment (120) is configured to receive the sealing adaptor (112a) to create the fluid tight seal when the concentrate disposable connector (110a) is coupled to the concentrate durable connector (116a).Claim 6: A disinfection system (102) for a dialysis machine (100), the disinfection system comprising: a disposable fluid line (106a) having a first end fluidly coupled to a concentrate container (108a) and a second end including a concentrate disposable connector (110a); a durable fluid line (114a) having a first end including a concentrate durable connector (116a), the concentrate durable connector (116a) configured to be fluidly coupled to the concentrate disposable connector (110a); and a housing (118) including: a connector compartment (120) having a lid (122) configured to cooperatively enclose at least the concentrate disposable connector (110a) coupled to the concentrate durable connector (116a), an aperture (202) in a wall (304) of the connector compartment (120) configured to receive the disposable fluid line (106) to create a fluid tight seal when the concentrate disposable connector (110a) is coupled to the concentrate durable connector (116a) and the lid (122) is closed,a first disinfection line (124) having a first end fluidly coupled to a first portion of a disinfectant recirculation path (126) and a second end fluidly coupled to the connector compartment (120), and a second disinfection line (128) having a first end fluidly coupled to the connector compartment (120) and a second end fluidly coupled to a second portion of the disinfectant recirculation path (126), at least a portion of the durable fluid line (114a) being enclosed within the second disinfection line (128).Claim 7: The disinfection system of Claim 6, further comprising a sealing adaptor (112a) connected to a portion of the disposable fluid line (106a) between the first end and the second end, wherein the aperture (202) in the wall of the connector compartment (120) is configured to receive the sealing adaptor (112a) to create the fluid tight seal when the concentrate disposable connector (110a) is coupled to the concentrate durable connector (116a).Claim 8: The disinfection system of Claims 6 or 7, wherein the disinfectant recirculation path (126) includes at least a heater (130) to heat a disinfection fluid and a recirculation pump (132) to push the disinfection fluid through the disinfectant recirculation path and through the connector compartment (120).Claim 9: The disinfection system of Claim 8, further comprising a control unit (140) communicatively coupled to the recirculation pump (132) and the heater (130), the control unit configured to: cause the heater (130) to heat the disinfection fluid; and cause the recirculation pump (132) to recirculate the disinfection fluid through the disinfectant recirculation path (126) and through the connector compartment (120).Claim 10: The disinfection system of Claim 9, further comprising a concentrate pump (104a), wherein a second end of the durable fluid line (114a) is fluidly coupled to the concentrate pump, andwherein the control unit (140) is communicatively coupled to the concentrate pump (104a) and configured to cause the concentrate pump (104a) to pump a fluid concentrate from the concentrate container (108a) through the disposable fluid line (106a) to the durable fluid line (114a) while causing the recirculation pump (132) to recirculate the disinfection fluid through the disinfectant recirculation path (126).Claim 11 : The disinfection system of Claims 8, 9, or 10, wherein the recirculation pump (132) is configured to push the disinfection fluid through the first disinfection line (124) to reach the connector compartment (120).Claim 12: The disinfection system of Claim 8 or 9, wherein the recirculation pump (132) is configured to push the disinfection fluid through the second disinfection line (128) to reach the connector compartment (120).Claim 13: The disinfection system of Claims 8, 9, or 10, wherein the disinfection fluid includes at least one of heated water, citric acid, or a disinfectant solution.Claim 14: The disinfection system of Claim 13, wherein the dialysis machine (100) is configured to receive water in the disinfectant recirculation path (126) from a water purification apparatus.Claim 15: The disinfection system of Claims 8, 9, or 10, further comprising a temperature sensor (134) located upstream from the heater (130) along the disinfectant recirculation path (126), the temperature sensor (134) communicatively coupled to the control unit (140) and configured to output a signal indicative of a temperature of the disinfection fluid upstream from the heater (130).Claim 16: The disinfection system of Claims 8, 9, or 10, wherein the control unit (140) is configured to heat the disinfection fluid to a programmed temperature between 60°C and 105°C and recirculate the disinfection fluid through the disinfectant recirculation path (126) for a time between 5 minutes and 30 minutes after detecting the temperature of the disinfection fluid has reached the programmed temperature.Claim 17: The disinfection system of Claims 9 or 16, further comprising a sensor (206) configured to sense when the lid is closed, wherein the control unit (140) is configured to cause the heater (130) to heat the disinfection fluid and the recirculation pump (132) to recirculate the disinfection fluid through the disinfectant recirculation path (126) after receiving a signal from the sensor (206) indicative that the lid (122) is closed.Claim 18: The disinfection system of Claims 8, 9, or 10, wherein the first disinfection line (124) includes an aperture (208), a portion of the durable fluid line (114a) forming a fluid tight seal at the aperture of the first disinfection line (124).Claim 19: The disinfection system of Claim 18, wherein at least the second end of the durable fluid line (114a) is external from the first disinfection line (124).Claim 20: The disinfection system of Claim 18, wherein the first disinfection line and the durable fluid line comprise a dual lumen pipe.Claim 21 : The disinfection system of Claim 20, wherein the durable fluid line is an inner lumen of the dual lumen pipe and the first disinfection line is an outer lumen of the dual lumen pipe that surrounds the inner lumen.Claim 22: The disinfection system of Claims 7, 8, or 9, wherein the concentrate container includes an osmotic agent such as glucose, a buffer concentrate fluid, or an electrolyte concentrate.Claim 23 : The disinfection system of Claims 7, 8, or 9, wherein the lid includes a tube seal configured to engage the sealing adaptor to form the fluid tight seal when the lid is closed.Claim 24: The disinfection system of Claim 8, further comprising: a second concentrate pump;36a second disposable fluid line having a first end fluidly coupled to a second concentrate container and a second end including a second concentrate disposable connector; a second sealing adaptor connected to a portion of the second disposable fluid line between the first end and the second end; and a second durable fluid line having a first end including a second concentrate durable connector and a second end fluidly coupled to the second concentrate pump, the second concentrate durable connector configured to be fluidly coupled to the second concentrate disposable connector, wherein the connector compartment and the lid are further configured to cooperatively enclose at least the second concentrate disposable connector coupled to the second concentrate durable connector, a second aperture in the wall of the connector compartment configured to receive the second sealing adaptor to create a fluid tight seal when the second concentrate disposable connector is coupled to the second concentrate durable connector and the lid is closed, and wherein at least a portion of the second durable fluid line is enclosed within the second disinfection line.Claim 25: The disinfection system of Claim 24, further comprising: a temperature sensor located upstream from the heater along the disinfectant recirculation path, the temperature sensor configured to output a signal indicative of a temperature of the disinfection fluid upstream from the heater; and a control unit (140) communicatively coupled to the recirculation pump (132) and the heater (130), the control unit configured to:(i) cause the heater to heat the disinfection fluid,(ii) cause the recirculation pump to recirculate the disinfection fluid through the disinfectant recirculation path including the first disinfection line and the second disinfection line,(iii) cause the concentrate pump to pump a fluid concentrate from the concentrate container through the durable fluid line, and(iv) cause the second concentrate pump to pump a second fluid concentrate from the second concentrate container through the second durable fluid line.37Claim 26: The disinfection system of Claim 25, wherein the control unit is configured to: perform (i) and (ii) to cause the disinfection fluid to reach a predetermined temperature; and perform (iii) and (iv) while performing (i) and (ii) after the disinfection fluid has reached the predetermined temperature.Claim 27: A disinfection method for a fluid generation machine, after a concentrate disposable connector of a disposable fluid line is fluidly coupled to a concentrate durable connector of a durable fluid line within a connector compartment having a lid configured to cooperatively enclose at least the concentrate disposable connector coupled to the concentrate durable connector, the disinfection method comprising:(i) causing, via a control unit, a heater to warm a disinfection fluid within a disinfectant recirculation path, the connector compartment being a part of the disinfectant recirculation path;(ii) causing, via the control unit, a recirculation pump of the disinfectant recirculation path to recirculate the disinfection fluid through the disinfectant recirculation path including the connector compartment; and(iii) causing, via the control unit, a concentrate pump to pump a fluid concentrate from a concentrate container through the durable fluid line while performing (i) and (ii) to heat disinfect insides and outsides of at least a portion of the durable fluid line, the concentrate durable connector, and the concentrate disposable connector.Claim 28: The disinfection method of Claim 27, further comprising: receiving, in the control unit from a temperature sensor located along the disinfectant recirculation path, a signal indicative of a temperature of the disinfection fluid; performing, via the control unit, (i) and (ii) to cause the disinfection fluid to reach a predetermined temperature; and performing, via the control unit, (iii) while performing (i) and (ii) after the disinfection fluid has reached the predetermined temperature.38Claim 29: The disinfection method of Claim 28, wherein the predetermined temperature is between 60°C and 105°C.Claim 30: The disinfection method of Claims 27 or 29, wherein (iii) is performed while performing (i) and (ii) for at least 5 minutes.Claim 31 : The disinfection method of Claim 27, further comprising causing, via the control unit, the disinfection fluid to be sent to a drain after (iii).Claim 32: The disinfection method of Claims 27 or 31, further comprising causing, via the control unit, at least some of the heated fluid concentrate to be sent to a drain after (iii).Claim 33: The disinfection method of Claims 27, 31, or 32, further comprising enabling, via the control unit, a dialysis treatment to be performed by the dialysis machine after (iii).39

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