Dialysis system cleaning / sterilizing mechanism and acid injection device used therefor

Abstract

To provide a dialysis system cleaning / sterilizing mechanism for effectively cleaning and removing calcium carbonate and protein with a cleaning / sterilizing solution composed of a pH-adjusted sodium hypochlorite solution and discharging the solution to a drainage canal within the range of the dialysis wastewater standards, and acid injection device used therefor.SOLUTION: A dialysis system cleaning / sterilizing mechanism comprises: a sodium hypochlorite tank 300 for supplying sodium hypochlorite through a sodium hypochlorite suction port of a dialysate supply device 200; and an acid injection device 100 for supplying acetic acid through a sample port for sampling dialysate in the dialysate supply device 200, where the acid injection device 100 includes an acid injection control unit for controlling an injection amount and injection timing of the sodium hypochlorite and acetic acid to switch and use the pH adjustment of the cleaning / sterilizing solution between an alkali side and an acid side in the dialysis wastewater standards.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present invention relates to a cleaning and sterilization mechanism for a dialysis system and an acid injection device used therein, and in particular to a cleaning and sterilization mechanism for a dialysis system that discharges used cleaning and sterilizing solution that complies with dialysis wastewater standards, and an acid injection device used therein. [Background technology]

[0002] Generally, in dialysis facilities such as hospitals and clinics where patients with impaired renal function undergo dialysis therapy, particularly hemodialysis via a dialysis machine, the used dialysis fluid that is returned to the dialysis machine contains waste products, excess water, electrolyte components, etc. from the patient's blood. Therefore, the dialysis machine is periodically disinfected and cleaned. Periodic disinfection and cleaning of such dialysis equipment prevents contaminants such as proteins and bacteria contained in used dialysis fluid from adhering to the piping inside the dialysis equipment through which the dialysis fluid travels, thereby reducing the functionality of the equipment and contaminating the patient's blood with bacteria through the dialysis membrane. It also prevents calcium, a component of the dialysis fluid that adjusts the blood concentration, from depositing inside the dialysis equipment and causing the dialysis equipment to malfunction. For disinfection, cleaning, etc. of such dialysis machines, an alkaline aqueous solution of sodium hypochlorite or the like is used to wash and remove proteins remaining in the dialysis machine as contaminants after dialysis treatment, and an acid aqueous solution of hydrochloric acid, acetic acid, or the like is used to wash and remove calcium carbonate remaining in the dialysis machine as a contaminant. In addition, in recent years, there have been incidents in which concrete sewer pipes have been damaged when dialysis wastewater discharged from dialysis facilities into the sewer system was acidic wastewater that significantly exceeded the sewerage bureau's sewage discharge standards. In response to this, three related organizations (the Japanese Society for Dialysis Therapy, the Japanese Society of Dialysis Physicians, and the Japanese Society of Clinical Engineers) have formulated dialysis wastewater standards for dialysis wastewater. According to this dialysis wastewater standard, the hydrogen ion exponent of used dialysis fluid and cleaning and sterilizing fluid at the time of dialysis wastewater must be pH 5 to 9.

[0003] In order to satisfy the dialysis wastewater standards for dialysis wastewater, a cleaning and sterilization mechanism for a dialysis system (see, for example, Patent Document 1) has been developed, which is used in a dialysis system equipped with a dialysis monitoring device c equipped with an artificial dialyzer as shown in FIG. 6, a dialysis fluid supplying device b that supplies dialysis fluid to the dialysis monitoring device c, an RO water generating device a that supplies RO water to the dialysis fluid supplying device b, and a drainage path that discharges used dialysis fluid from the dialysis monitoring device c, and uses the alkaline aqueous solution d and the acid aqueous solution e supplied as cleaning and sterilizing fluid into the dialysis fluid supplying device b by selectively diluting them with the RO water from the RO water generating device a to clean and sterilize the dialysis monitoring device c, and then neutralizes the wastewater consisting of the used alkaline aqueous solution and acid aqueous solution using a neutralizing agent in a neutralizing tank f provided on the drainage path on the drain outlet g side downstream of the dialysis monitoring device c. On the other hand, there is a cleaning and sterilization mechanism for a dialysis system (see, for example, Patent Document 2) that is used in a dialysis system including a dialysis monitoring device c equipped with an artificial dialyzer as shown in FIG. 7, a dialysis fluid supplying device b that supplies dialysis fluid to the dialysis monitoring device c, an RO water generating device a that supplies RO water to the dialysis fluid supplying device b, and a drainage path that discharges the dialysis fluid used in the dialysis monitoring device c, and that supplies hyponitrous active water prepared as a cleaning and sterilizing solution that does not require neutralization treatment by mixing a large amount of RO water with an alkaline aqueous solution d and an acid aqueous solution e in a hyponitrous active water preparation device h provided on the RO water supply path on the receiving port side upstream of the dialysis fluid supplying device b to the dialysis monitoring device c via a liquid delivery pump h1, an on-off valve j, and the dialysis fluid supplying device b to clean and sterilize the dialysis monitoring device c. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Japanese Patent Application Publication No. 5-38495 [Patent Document 2] JP 2004-130017 A Summary of the Invention [Problem to be solved by the invention]

[0005] However, in the cleaning and sterilization mechanism of the former dialysis system, not only is it necessary to secure sufficient space to install a neutralization tank f of the used cleaning and sterilizing solution on the drainage path on the drain outlet g side downstream of the dialysis monitoring device c, but there is also the problem that sufficient neutralization treatment using a neutralizing agent must be performed in this neutralization tank f to meet the sewage discharge standards. Also, in the latter system, an extra hypochlorous water preparation device h must be installed on the RO water supply path on the receiving inlet side upstream of the dialysis fluid supply device b, and since a large liquid delivery pump is used for this hypochlorous water preparation device h, the cleaning and sterilization mechanism itself tends to be large, and there is a troublesome problem of installation space, even though dialysis facilities in urban areas are often located in one room of a building.

[0006] Therefore, the present invention solves the problems of the prior art as described above. That is, the object of the present invention is to provide a cleaning and sterilization mechanism for a dialysis system that can be easily attached to a dialysis fluid supplying device without significantly changing the installation layout or installation space of an existing dialysis system, and that can be used to clean and remove piping and the like in a dialysis monitoring device and discharge the dialysis wastewater into a drainage channel within the range of the dialysis wastewater standard without using a neutralizing agent, by switching between a slightly acidic hypochlorous acid aqueous solution that effectively cleans and removes calcium carbonate and a sodium hypochlorite aqueous solution that effectively cleans and removes proteins as a cleaning and sterilization solution by adjusting the pH of each solution and switching between them. [Means for solving the problem]

[0007] The invention according to claim 1 is a cleaning and sterilization mechanism for a dialysis system which cleans and sterilizes the dialysis monitoring device, the dialysis monitoring device being provided with an artificial dialyzer, a dialysis fluid supplying device which supplies dialysis fluid to the dialysis monitoring device, a dialysis drug dissolving device which supplies two types of dialysis stock solutions for preparing the dialysis fluid to the dialysis fluid supplying device, respectively, an RO water supply line which supplies RO water to the dialysis drug dissolving device and the dialysis fluid supplying device, respectively, and a drainage line which discharges the dialysis fluid used in the dialysis monitoring device, the cleaning and sterilization mechanism for a dialysis system being provided with a dialysis monitoring device having an artificial dialyzer attached thereto, a dialysis fluid supplying device which supplies dialysis fluid to the dialysis fluid supplying device, the cleaning and sterilization mechanism comprising: a dialysis fluid supplying device which supplies dialysis fluid to the dialysis fluid supplying device through a sodium hypochlorite suction port of the dialysis fluid supplying device; The apparatus is made up of a sodium hypochlorite tank that supplies a sodium hypochlorite solution to the dialysis fluid supplying device, and an acid tank that supplies a dilution solution obtained by diluting one of the two types of dialysis stock solutions supplied into the dialysis fluid supplying device, or an acid to the dialysis fluid supplying device via a sample port of the dialysis fluid supplying device that tests and collects the dialysis fluid. The acid injection device has an acid injection control unit that switches between adjusting the pH of the cleaning and sterilizing solution to the alkaline side or the acid side within the dialysis wastewater standards by controlling the injection amount and injection timing of the sodium hypochlorite and the acid that are mixed and diluted with the RO water, thereby solving the above-mentioned problem.

[0008] The invention of claim 2 further solves the above-mentioned problem by, in addition to the configuration of the cleaning and sterilization mechanism of the dialysis system described in claim 1, connecting the acid injection control unit of the acid injection device to the dialysis fluid supply control unit in the dialysis fluid supply device.

[0009] The invention of claim 3 solves the above-mentioned problem by, in addition to the configuration of the cleaning and sterilization mechanism of the dialysis system described in claim 1 or 2, connecting an acid injection control unit of the acid injection device to a flow meter provided in an RO water supply line that supplies RO water to the dialysis fluid supply device.

[0010] The invention of claim 4 further solves the above-mentioned problem by, in addition to the configuration of the cleaning and sterilization mechanism of the dialysis system described in claim 1 or 2, connecting the acid injection control unit of the acid injection device to a sodium hypochlorite solenoid valve open detection sensor in the dialysis fluid supply device.

[0011] The invention of claim 5 further solves the above-mentioned problem by, in addition to the configuration of the cleaning and sterilization mechanism of the dialysis system described in claim 1 or 2, connecting an acid injection control unit of the acid injection device to an RO water solenoid valve open detection sensor in the dialysis fluid supply device.

[0012] The invention of claim 6 is an acid injection device for use in the cleaning and sterilization mechanism of the dialysis system according to claim 1 or 2, which further solves the above-mentioned problems by comprising an acid pump for delivering acid supplied from the acid tank, a back pressure check valve interposed between the acid pump and the sodium hypochlorite suction port of the dialysis fluid supply device, an acid supply path piped downstream of the back pressure check valve and connectable to the sample port, and a safety valve provided in a reduction path directly connecting the acid supply path to the acid tank. Effect of the Invention

[0013] According to the cleaning and sterilization mechanism of the dialysis system of the invention of claim 1, the mechanism is composed of a sodium hypochlorite tank that supplies sodium hypochlorite to the dialysis fluid supplying device through the sodium hypochlorite suction port of the dialysis fluid supplying device, and an acid tank that supplies a dilution solution obtained by diluting one of the two types of dialysis stock solutions supplied into the dialysis fluid supplying device or an acid to the dialysis fluid supplying device through a sample port of the dialysis fluid supplying device that samples the dialysis fluid for testing, thereby making it possible to provide an existing dialysis system having at least a dialysis monitoring device and a dialysis fluid supplying device that supplies dialysis fluid to the dialysis monitoring device with sodium hypochlorite. By additionally connecting the tank and the acid injection device, a simple cleaning and sterilizing mechanism for the cleaning and sterilizing liquid is constructed, so there is no need to install a neutralization tank on the drainage line to neutralize the used cleaning and sterilizing liquid using a neutralizing agent, as in the conventional case, or to install a hypochlorous water preparation device on the RO water supply line to prepare hypochlorous water as a cleaning and sterilizing liquid that does not require neutralization treatment.As a result, not only can it be easily attached to the dialysis liquid supply device without significantly changing the installation layout or installation space of the existing dialysis system, but the dialysis liquid and the cleaning and sterilizing liquid can be prepared by sharing the same RO water supplied to the dialysis liquid supply device and easily switching between them. The acid injection device connected to the dialysis fluid supply device has an acid injection control unit that controls the injection amount and injection timing of sodium hypochlorite and acid mixed and diluted with RO water to switch between the alkaline and acid sides of the dialysis wastewater standard pH adjustment of the cleaning sterilization solution. This acid injection control unit can control the pH adjustment of the cleaning sterilization solution to the acid and alkaline sides of the dialysis wastewater standard. Therefore, when a cleaning sterilization solution consisting of a slightly acidic hypochlorous acid aqueous solution whose pH is adjusted to the acid side (e.g., pH 5 to 6, particularly preferably pH 5.2 to 5.5) of the dialysis wastewater standard is selected, calcium carbonate attached to the piping, etc. in the dialysis monitoring device can be effectively washed and removed, and when a cleaning sterilization solution consisting of a sodium hypochlorite aqueous solution whose pH is adjusted to the alkaline side (e.g., pH 8.0 to 8.5) of the dialysis wastewater standard is selected, the concentration of chloride ions is high, and not only can the protein attached to the piping, etc. in the dialysis monitoring device be effectively washed and removed, but also these used cleaning sterilization solutions can be discharged into the drainage channel within the range of the dialysis wastewater standard pH 5 to 9 without using a neutralizing agent.

[0014] According to the cleaning and sterilization mechanism for a dialysis system of the invention of claim 2, in addition to the effects achieved by the cleaning and sterilization mechanism for a dialysis system of the invention according to claim 1, the acid injection control unit of the acid injection device is connected to the dialysis fluid supply control unit in the dialysis fluid supply device, so that the control of the acid injection device and the control of the dialysis fluid supply device are linked, and therefore it is possible to reliably control the injection amount and injection timing of the sodium hypochlorite and acid that are mixed and diluted with the RO water supplied to the dialysis fluid supply device.

[0015] According to the cleaning and sterilization mechanism for a dialysis system of the invention of claim 3, in addition to the effects achieved by the cleaning and sterilization mechanism for a dialysis system of the invention according to claim 1 or 2, the acid injection control unit of the acid injection device is connected to a flow meter provided in the RO water supply line that supplies RO water to the dialysis fluid supply device, so that the volume of RO water supplied to the dialysis fluid supply device can be detected. This makes it possible to reliably control the injection amounts of sodium hypochlorite and acid to be mixed and diluted with RO water, and to prepare a uniform cleaning and sterilization solution by mixing and diluting sodium chlorite and acid in RO water.

[0016] According to the cleaning and sterilization mechanism for a dialysis system of the invention of claim 4, in addition to the effects achieved by the cleaning and sterilization mechanism for a dialysis system of the invention according to claim 1 or 2, the acid injection control unit of the acid injection device is connected to the sodium hypochlorite solenoid valve open detection sensor in the dialysis fluid supplying device, and the acid injection control unit of the acid injection device synchronizes the timing of supplying acid from the acid injection device to the dialysis fluid supplying device with the timing of supplying sodium hypochlorite from the sodium hypochlorite tank to the dialysis fluid supplying device based on the sodium hypochlorite solenoid valve open detection signal of the sodium hypochlorite solenoid valve open detection sensor, so that the pH of the cleaning and sterilization solution obtained by injection and mixing can be adjusted by controlling the injection amount and injection speed of the sodium hypochlorite and acid injected into the dialysis fluid supplying device.

[0017] According to the cleaning and sterilization mechanism for a dialysis system of the invention of claim 5, in addition to the effects achieved by the cleaning and sterilization mechanism for a dialysis system of the invention according to claim 1 or 2, the acid injection control unit of the acid injection device is connected to the RO water solenoid valve open detection sensor in the dialysis fluid supplying device, so that the acid injection control unit of the acid injection device adjusts and synchronizes the timing of supplying acid from the acid injection device to the dialysis fluid supplying device and the timing of supplying sodium hypochlorite from the sodium hypochlorite tank to the dialysis fluid supplying device based on the receiving solenoid valve open detection signal of the RO water solenoid valve open detection sensor, so that the RO water supplied to the dialysis fluid supplying device can be reliably mixed and diluted with sodium hypochlorite and acid.

[0018] According to the acid injection device of the invention of claim 6, in addition to the effects achieved by the cleaning and sterilization mechanism of the dialysis system of the invention according to claim 1 or 2, the acid injection device is provided with an acid pump that delivers acid supplied from an acid tank, a back pressure check valve interposed between the acid pump and the sodium hypochlorite suction port of the dialysis fluid supply device, an acid supply path that is piped downstream of the back pressure check valve and can be freely connected to the sample port, and a safety valve provided in a reduction path that directly connects from the acid supply path to the acid tank. Therefore, even if abnormally high pressure or backflow of acid occurs downstream of the back pressure check valve, the back pressure check valve and the safety valve prevent abnormally high pressure accompanying the supply of acid, so that the acid pump can be operated smoothly, thereby achieving excellent safety and durability of the acid injection device. [Brief description of the drawings]

[0019] [Figure 1] FIG. 1 is a conceptual diagram of a dialysis system incorporating a cleaning and sterilization mechanism according to one embodiment of the present invention. [Diagram 2] FIG. 1 is a system configuration diagram of a dialysis system incorporating a cleaning and sterilization mechanism according to one embodiment of the present invention. [Diagram 3] FIG. 2 is a diagram illustrating a connection form of a dialysis fluid during dialysis treatment according to the present invention. [Figure 4] FIG. 2 is a diagram illustrating a cleaning and sterilization mechanism of the dialysis system during cleaning and sterilization of the present invention. [Diagram 5] 4 is a flowchart illustrating the operation of the cleaning and sterilization mechanism during cleaning and sterilization of the present invention. [Figure 6] FIG. 1 is a diagram showing a cleaning and sterilization mechanism provided downstream of a conventional dialysis monitoring device. [Figure 7] FIG. 1 is a diagram showing a cleaning and sterilization mechanism provided upstream of a conventional dialysis monitoring device. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0020] The cleaning and sterilization mechanism of the dialysis system of the present invention is composed of a sodium hypochlorite tank that supplies sodium hypochlorite to the dialysis fluid supplying device through the sodium hypochlorite suction port of the dialysis fluid supplying device, and an acid injection device having an acid tank that supplies a dilution solution obtained by diluting one of the two types of dialysis stock solutions supplied into the dialysis fluid supplying device or an acid to the dialysis fluid supplying device through a sample port of the dialysis fluid supplying device that tests and collects the dialysis fluid, and the acid injection device has an acid injection control unit that switches and uses the pH adjustment of the cleaning and sterilization solution to the alkaline side and the acid side within the sewage removal standard by controlling the injection amount and injection timing of sodium hypochlorite and acid mixed and diluted with RO water, and can be easily attached to the dialysis fluid supplying device without significantly changing the installation layout or installation space of the existing dialysis system, and the cleaning and sterilization solution is adjusted to a slightly acidic hypochlorous acid aqueous solution that effectively washes and removes calcium carbonate, or a sodium hypochlorite aqueous solution that effectively washes and removes proteins, and the pH is adjusted to a slightly acidic hypochlorous acid aqueous solution that effectively washes and removes proteins as a cleaning and sterilization solution, and the piping and the like in the dialysis monitoring device are washed and removed, and then the solution is discharged into a drain within the range of the dialysis wastewater standard. Any specific embodiment may be used.

[0021] For example, the present invention provides a cleaning and sterilization mechanism for cleaning and sterilizing a dialysis monitoring device that includes a dialysis monitoring device equipped with an artificial dialyzer, a dialysis fluid supplying device that supplies dialysis fluid to the dialysis monitoring device, a dialysis drug dissolving device that supplies dialysis stock fluid to the dialysis fluid supplying device, an RO water generating device that supplies RO water to the dialysis drug dissolving device and the dialysis fluid supplying device via an RO water supply path, and a drainage path that discharges the dialysis fluid used in the dialysis monitoring device. Needless to say, a cleaning and sterilization mechanism for a dialysis system can be constructed as long as RO water can be supplied to the dialysis fluid supplying device to discharge the dialysis fluid used in the dialysis monitoring device and acid can be supplied to the dialysis fluid supplying device from an acid injecting device.

[0022] The term "dialysis solution" as used herein refers to a perfusion solution for hemodialysis prepared by diluting and preparing a dialysis concentrate called "liquid A" in which an agent A, the main component of which is electrolytes, glucose, etc., is dissolved in RO water, and a dialysis concentrate called "liquid B" in which an agent B, the main component of which is sodium bicarbonate, is dissolved in RO water, for example, in a ratio of "liquid A:liquid B:RO water" = 1:1.26:32.74. The term "diluted solution" as used herein refers to a solution prepared by diluting one of the two types of dialysis concentrates called "liquid A" and "liquid B" described above, i.e., liquid B. On the other hand, the acid supplied from the acid injection device described above is most preferably acetic acid, which is a weak acid, and can attack and sterilize the inside of bacteria remaining as contaminants in the dialysis monitoring device in a short time at a low concentration, and can be used to effectively wash and remove calcium carbonate in a slightly acidic aqueous solution of hypochlorous acid at about 30 to 600 ppm, and can effectively wash and remove protein in an aqueous solution of sodium hypochlorite. However, it is also acceptable to use peracetic acid, citric acid, or hydrochloric acid if the dilution conditions are taken into consideration.

[0023] In addition, the dialysis fluid supplying device (so-called central) used in the present invention is a multi-person dialysis fluid supplying device connected to multiple dialysis monitoring devices (so-called consoles) in a large-scale dialysis facility, but it may also be connected to a personal dialysis device. As for the specific connection form of the sample port of the dialysis fluid supplying device for supplying acid from the acid injection device, the acid injection device was connected to the sample port for liquid B, which is installed for test-collecting a "diluted liquid" obtained by diluting liquid B, which is one of the two types of dialysis stock solutions supplied into the dialysis fluid supplying device as described above and dissolved with RO water, but the acid injection device may also be connected to a sample port for dialysis fluid, which collects a test sample of the dialysis fluid. Furthermore, if a luer lock type (screw-in type) luer connector is used for the sample ports for solution B and dialysis fluid to prevent the connection site from coming loose, an even more reliable connection can be achieved.

[0024] As described above, the dialysis drug dissolving device is used to dissolve powdered dialysis agents consisting of agents A and B in RO water to obtain two types of dialysis concentrates called solutions A and B. However, when liquid dialysis agents are used, the dialysis drug dissolving device is not necessarily required. The RO water generator removes impurities from raw water such as tap water by reverse osmosis to generate pure and highly clean water (RO water) used for preparing dialysis fluid, and supplies the generated RO water to a dialysis drug dissolving device and a dialysis fluid supplying device via an RO water supply line. However, the dialysis system of the present invention does not necessarily require an RO water generator and a dialysis drug dissolving device as essential components as long as it can supply two types of dialysis raw solutions, referred to as solution A and solution B, to the dialysis fluid supplying device.

[0025] Furthermore, the specific form of the RO water solenoid valve open detection sensor and the sodium hypochlorite solenoid valve open detection sensor provided in the dialysis fluid supplying device is configured as a reed switch or a Hall element that is arranged so as to react to the leakage magnetic field around the electromagnetic coil of the solenoid valve arranged in the dialysis fluid supplying device, but any type may be used as long as it is capable of sending a detection signal to the acid injection control unit of the acid injection device. For example, the sensor may be provided on the drive cable of the solenoid valve arranged in the dialysis fluid supplying device and configured to utilize the principle of a clamp-type ammeter, or the sensor may be configured to directly extract a current from the drive cable of the solenoid valve to detect the open valve state.

[0026] Furthermore, regarding the specific installation position of the flow meter, it is preferable to install it on the RO water supply path connecting the RO water generating apparatus and the dialysis fluid supplying apparatus, since this allows for easy handling of the flow meter, but it can also be installed, for example, in the RO water flow path in the dialysis fluid supplying apparatus.

[0027] Hereinafter, a cleaning and sterilization mechanism of a dialysis system according to one embodiment of the present invention will be described with reference to Figs.

[0028] <1. Overview of dialysis system> An outline of a dialysis system incorporating a cleaning and sterilization mechanism for a dialysis system according to one embodiment of the present invention will now be described with reference to Figs. 1 and 2.

[0029] As shown in FIG. 1, the dialysis system includes an acid injector 100, a dialysis fluid supplying device 200 to which the acid injector 100 supplies acid, a sodium hypochlorite tank 300 to which sodium hypochlorite is supplied to the dialysis fluid supplying device 200, a dialysis monitoring device 400, an RO water supply line W to which RO water is supplied to the dialysis fluid supplying device 200, and a drainage line D to which the dialysis fluid used by the dialysis monitoring device 400 is discharged. The above-mentioned dialysis monitoring device 400 can be fitted with an artificial dialyzer 410 which can be replaced for each dialysis patient P, and the dialysis patient P receives hemodialysis via the artificial dialyzer 410 during dialysis treatment.

[0030] The RO water generating apparatus 600 is connected to the dialysis drug dissolving apparatus 700A, the dialysis drug dissolving apparatus 700B, and the dialysis fluid supplying apparatus 200 via an RO water supply passage W. In addition, the dialysis drug dissolving device 700A is connected to the dialysis fluid supplying device 200 via a supply path A for dialysis concentrate consisting of liquid A, and the dialysis drug dissolving device 700B is connected to the dialysis fluid supplying device 200 via a supply path B for dialysis concentrate consisting of liquid B.

[0031] <2. Dialysis system configuration> Next, the configuration of a dialysis system 1 into which a cleaning and sterilization mechanism of a dialysis system according to one embodiment of the present invention is incorporated will be described with reference to Figs.

[0032] First, as shown in FIG. 3, the dialysis system basically comprises an acid injector 100, a dialysis fluid supplying device 200, a sodium hypochlorite tank 300, a dialysis monitoring device 400, an RO water supply line W, and a drainage line D.

[0033] <2.1.RO water supply path> The RO water supply passage W is a flow path that supplies the RO water generated in the RO water generation device 600. The RO water generating device 600 is a device that removes impurities from raw water such as tap water by reverse osmosis and generates highly pure and clean water (RO water) that can be used to prepare dialysis fluid. The RO water generated in the RO water generating apparatus 600 is supplied to the dialysis drug dissolving apparatuses 700A and 700B via one of two RO water supply lines W, and is supplied to the dialysis fluid supplying apparatus 200 via the other line.

[0034] <2.2. Dialysis drug dissolving device> The dialysis drug dissolving device 700A and the dialysis drug dissolving device 700B are devices that dissolve powdered dialysis agents A and B (not shown), respectively, in RO water to create a dialysis concentrate consisting of solution A and a dialysis concentrate consisting of solution B. The dialysis drug dissolving device 700A supplies dialysis stock solution consisting of liquid A through supply path A of the dialysis fluid supplying device 200, and the dialysis drug dissolving device 700B supplies dialysis stock solution consisting of liquid B through supply path B of the dialysis fluid supplying device 200.

[0035] <2.3. Dialysate supply device> The dialysis fluid supply device 200 is at least composed of a dialysis fluid supply control unit 210, a water receiving solenoid valve 220, a sodium hypochlorite suction port 230, a sodium hypochlorite solenoid valve 240, a sodium hypochlorite pump 250, a sample port 260 for solution B, and a sample port 270 for dialysis fluid.

[0036] The dialysis fluid supplying device 200 has a first flow path 220A, a second flow path 230A, and a third flow path 260A. Here, this first flow path 220A is connected to an RO water supply path W to receive RO water from the RO water supply path W, while being connected to a dialysis monitoring device 400 via a dialysis fluid supply path F, and further connected to a drainage path D via the dialysis monitoring device 400. Further, the second flow path 230A is a flow path connected to a sodium hypochlorite tank 300 described later, and receives a supply of sodium hypochlorite from the sodium hypochlorite tank 300 during the cleaning and sterilization process. Further, the second flow path 230A merges with the first flow path 220A. Furthermore, the third flow path 260A is connected to the acid injection device 100 described later, and receives a supply of acid from the acid injection device 100 via a sample port 260 for solution B or a sample port 270 for dialysis fluid described later during cleaning and sterilization, while merging with the first flow path 220A. The sample port 260 for solution B or the sample port 270 for dialysis fluid is connected to the acid injection device 100 during cleaning and sterilization, but during dialysis treatment, the tip of the acid supply path 140A removed from the sample port 260 for solution B or the sample port 270 for dialysis fluid, and the tip of the sample port removed from the acid injection device 100 are each closed with a stopper.

[0037] Hereinafter, each component of the dialysis fluid supplying device 200 will be described in more detail with reference to FIGS. First, the dialysis fluid supply control unit 210 of this dialysis fluid supplying device 200 is configured to be able to control the operation of the receiving solenoid valve 220, the sodium hypochlorite solenoid valve 240, and the sodium hypochlorite pump 250, and is capable of sending an equivalent signal S4, which is a signal equivalent to the receiving solenoid valve open detection signal S2 and the sodium hypochlorite solenoid valve open detection signal S3, to the acid injection control unit 110 of the acid injection device 100, as described below.

[0038] The receiving solenoid valve 220 is a solenoid valve that can switch between supplying and stopping the RO water, and is provided on the first flow path 220A near the connection point with the RO water supply path W. The dialysis fluid supply control unit 210 controls opening and closing of the solenoid valve 220.

[0039] The receiving solenoid valve open detection sensor 221 is configured as a reed switch or a Hall element arranged to react to the leakage magnetic field around the electromagnetic coil of the receiving solenoid valve 220, is arranged integral with or around the receiving solenoid valve 220, detects that the receiving solenoid valve 220 is in the open state, and sends a receiving solenoid valve open detection signal S2 to the acid injection control unit 110 of the acid injection device 100.

[0040] Furthermore, the sodium hypochlorite suction port 230 is connected to a sodium hypochlorite tank 300, and receives a supply of sodium hypochlorite from the sodium hypochlorite tank 300 during cleaning and sterilization. That is, the sodium hypochlorite suction port 230 is connected to the second flow path 230A, and this second flow path 230A is configured as a flow path from the sodium hypochlorite suction port 230 to the junction with the first flow path 220A.

[0041] In addition, the sodium hypochlorite solenoid valve 240 can switch between supplying and stopping sodium hypochlorite, and is provided near the sodium hypochlorite suction port 230 on the second flow path 230A. The opening and closing of the solenoid valve 240 is controlled by the dialysis fluid supply control unit 210.

[0042] The sodium hypochlorite solenoid valve open detection sensor 241 is provided integrally with or around the sodium hypochlorite solenoid valve 240 and is configured as a reed switch or Hall element that reacts to the leakage magnetic field around the electromagnetic coil of the sodium hypochlorite solenoid valve 240.The sodium hypochlorite solenoid valve open detection sensor 241 detects that the sodium hypochlorite solenoid valve 240 is in the open state and sends a sodium hypochlorite solenoid valve open detection signal S3 to the acid injection control unit 110 of the acid injection device 100.

[0043] Furthermore, the sodium hypochlorite pump 250 is capable of switching between sending and stopping the sending of sodium hypochlorite toward the first flow path 220A, and is provided downstream of the sodium hypochlorite solenoid valve 240 on the second flow path 230A arranged downstream of the above-mentioned sodium hypochlorite suction port 230, and its operation is controlled by the dialysis fluid supply control unit 210.

[0044] The sample port 260 for the B solution is a port for testing and collecting a diluted solution of the B solution obtained by mixing and diluting the dialysis concentrate made of the B solution with the RO water supplied to the first flow path 220A, and for the administrator of the dialysis facility to check the dilution concentration of the B solution before performing dialysis treatment.

[0045] In addition, the sample port 270 for the dialysis fluid is a port for testing and sampling the dialysis fluid obtained by mixing the dialysis stock solution consisting of the above-mentioned B liquid with RO water to obtain a diluted solution of B liquid, which is provided on the first flow path 220A, and for the administrator of the dialysis facility to check the concentration of the dialysis fluid before performing dialysis treatment.

[0046] In addition, a luer lock type (screw type) luer connector is used for the sample port 260 for the B fluid and the sample port 270 for the dialysis fluid in order to prevent the connection parts from coming loose.

[0047] The dialysis fluid supplying device 200 obtained in this manner prepares a cleaning and sterilization solution adjusted to a predetermined pH value by mixing and diluting the acid supplied from the acid injection device 100 described below via the sample ports with sodium hypochlorite inside the dialysis fluid supplying device 200 through the first flow path 220A, the second flow path 230A, and the third flow path 260A configured as described above during cleaning and sterilization. At this time, as a port for injecting acid into the dialysis fluid supplying device 200, a sample port 260 for solution B to check the dilution degree of solution B, etc., can be used, or a sample port 270 for dialysis fluid to check the component concentrations of the dialysis fluid prepared inside the dialysis fluid supplying device 200 can be used.

[0048] <2.4. Sodium hypochlorite tank> The sodium hypochlorite tank 300 is a tank in which sodium hypochlorite is stored to be supplied to the dialysis fluid supplying device 200 via the sodium hypochlorite suction port 230 during cleaning and sterilization.

[0049] <2.5. Dialysis monitoring device> The dialysis monitoring device 400 is a device that monitors the dialysate flow rate, temperature, venous pressure, etc. during hemodialysis, and multiple devices are installed for each dialysis patient in a dialysis facility.

[0050] <2.6. Acid injection device> The acid injection device 100 is composed of an acid injection control unit 110, an acid tank 120, an acid pump 130, a back pressure check valve 140, and a safety valve 150, and receives a water receiving solenoid valve open detection signal S2 from the water receiving solenoid valve open detection sensor 221 of the dialysis fluid supplying device 200 and a sodium hypochlorite solenoid valve open detection signal S3 from the sodium hypochlorite solenoid valve open detection sensor 241 of the dialysis fluid supplying device 200, or receives an equivalent signal S4 from the dialysis fluid supply control unit 210 of the dialysis fluid supplying device 200, and sends an acid pump drive signal S5 to the acid pump 130, thereby becoming able to control the operation of the acid pump 130. Here, it goes without saying that the acid injection control unit 110 can use the receiving water flow rate signal S1 instead of the receiving water electromagnetic valve open detection signal S2.

[0051] The acid tank 120 stores acetic acid as the acid to be supplied to the dialysis fluid supplying device 200 during the cleaning and sterilization process. The acid pump 130 is connected to the acid tank 120 and receives a supply of acetic acid from the acid tank 120. The acid pump 130 is controlled by the acid injection control unit 110 to switch between sending and stopping the sending of acetic acid to the dialysis fluid supplying device 200 and to adjust the flow rate.

[0052] The back pressure check valve 140 is provided downstream of the acid pump 130 and is an on-off valve that limits the movement of acetic acid between the acid injector 100 and the dialysis fluid supplying device 200. The back pressure check valve 140 prevents backflow of acid from the dialysis fluid supplying device 200 to the acid pump 130 of the acid injector 100, thereby allowing the acid pump 130 to operate smoothly and ensuring the excellent durability of the acid injector 100. In addition, downstream of this back pressure check valve 140, an acid supply line 140A is piped so as to be freely connectable to the sample port 260 side. Further, a reduction flow line 150A is provided which directly connects this acid supply line 140A to the acid tank 120, and a safety valve 150 is provided in this reduction flow line 150A. Even if abnormally high pressure or backflow of acid occurs downstream of the back pressure check valve 140, the back pressure check valve 140 and the safety valve 150 prevent abnormally high pressure caused by the supply of acid, so that the acid injection apparatus 100 can exhibit its excellent safety and the acid pump 130 can operate smoothly.

[0053] <2.7. Drainage channel> The drainage channel D is basically a flow path for discharging the dialysis fluid used in the dialysis monitoring device 400 during dialysis treatment, but during cleaning and sterilization, the used cleaning and sterilization fluid (waste fluid) is discharged into the drain 800 (i.e., the sewer system).

[0054] <2.8.Other> The flow meter 500 measures the flow rate (amount of received water) of RO water supplied to the dialysis fluid supplying device 200 via the RO water supply path W in order to send the measured amount of received water to the acid injection control unit 110 of the acid injection device 100 as a received water flow rate signal S1.

[0055] <3. Operation flow during cleaning and sterilization> Next, the most distinctive operation during cleaning and sterilization in the dialysis system 1 incorporating the cleaning and sterilization mechanism of the dialysis system according to one embodiment of the present invention will be described with reference to FIG.

[0056] First, at the start of cleaning and sterilization, the acid pump 130 of the acid injector 100 is turned off (step S101). That is, at this point, the acid pump 130 has not yet started to deliver acetic acid supplied from the acid tank 120 to the dialysis fluid supplying device 200.

[0057] Next, when the sodium hypochlorite solenoid valve 240 of the dialysis fluid supplying device 200 is not ON, that is, when it is in the closed state (NO in step S102), the process returns to step S101.

[0058] When the sodium hypochlorite solenoid valve 240 is ON, that is, when it is in an open state (YES in step S102), the process proceeds to step S103.

[0059] Furthermore, when the water receiving solenoid valve 220 of the dialysis fluid supplying device 200 is not ON, that is, when it is in the closed state (NO in step S103), the process returns to step S101.

[0060] Here, in the above-mentioned step S103, when both the sodium hypochlorite solenoid valve 240 and the water receiving solenoid valve 220 are in an open state in which they are ON (YES in step S103), the process proceeds to the next step, and the acid pump 130 of the acid injection apparatus 100 is turned ON (step S104). That is, the acid pump 130 starts to pump the acid supplied from the acid tank 120 to the dialysis fluid supplying device 200 .

[0061] Next, when the sodium hypochlorite solenoid valve 240 is in an open state in which it is turned ON (YES in step S105), the process proceeds to step S106.

[0062] When the water receiving solenoid valve 220 is in an open state in which it is turned ON (YES in step S106), the process returns to step S104.

[0063] On the other hand, when the sodium hypochlorite solenoid valve 240 is not ON and is in a closed state (NO in step S105) and when the water receiving solenoid valve 220 is not ON and is in a closed state (NO in step S106), the acid pump 130 of the acid injector 100 is turned OFF (step S101). That is, the above steps S101 to S106 are repeated.

[0064] <4. Coordinated control between the acid injection device and the dialysis fluid supply device> The present invention relates to cooperative control between the acid injector 100 and the dialysis fluid supplying device 200. The following describes in detail the control for cooperative operation of the acid pump 130 of the acid injector 100 and the sodium hypochlorite pump 250 of the dialysis fluid supplying device 200.

[0065] First, as shown in the operational flowchart of FIG. 5, during cleaning and sterilization, "both the water receiving solenoid valve 220 and the sodium hypochlorite solenoid valve 240 are ON in the open state," and the acid pump 130 of the acid injection apparatus 100 is turned ON (steps S102, S103, S104). Furthermore, when the "open state in which both the water receiving solenoid valve 220 and the sodium hypochlorite solenoid valve 240 are ON" is no longer present, the acid pump 130 is turned OFF (steps S105, S106, S107).

[0066] The dialysis fluid supply control unit 210 of the dialysis fluid supplying device 200 is configured to be able to control the operations of the water receiving solenoid valve 220, the sodium hypochlorite solenoid valve 240, and the sodium hypochlorite pump 250, as described above. Therefore, the dialysate supply control unit 210 is controlled so that the sodium hypochlorite pump 250 is turned ON in the "open state in which both the water receiving solenoid valve 220 and the sodium hypochlorite solenoid valve 240 are ON".

[0067] Furthermore, when the sodium hypochlorite solenoid valve 240 is in an open state in which it is turned on, the dialysis fluid supply control unit 210 can send a signal indicating the start of a cleaning and sterilization process to the outside of the dialysis fluid supply device 200. On the other hand, the dialysis fluid supplying device 200 does not have a configuration equivalent to a sensor that detects the operation of the sodium hypochlorite pump 250, and the dialysis fluid supply control unit 210 cannot output a signal indicating the start of operation of the sodium hypochlorite pump 250 to the outside of the dialysis fluid supplying device 200 when the sodium hypochlorite pump 250 is turned ON.

[0068] Therefore, when "both the water receiving solenoid valve 220 and the sodium hypochlorite solenoid valve 240 are ON (open state)", the dialysis fluid supply control unit 210 controls the sodium hypochlorite pump 250 to be ON, and sends the fact that "both the water receiving solenoid valve 220 and the sodium hypochlorite solenoid valve 240 are ON (open state)" to the acid injection control unit 110 of the acid injection device 100 as a signal equivalent to the sodium hypochlorite pump 250 being ON, i.e., the above-mentioned equivalent signal S4. Then, upon receiving the equivalent signal S4, the dialysis fluid supply control unit 210 sends an acid pump drive signal S5 to the acid pump 130 to control the operation of the acid pump 130, thereby causing the acid pump 130 and the sodium hypochlorite pump 250 to operate in substantial coordination even though they cannot be directly synchronized.

[0069] As is clear from the above description, the cleaning and sterilization mechanism of the dialysis system according to one embodiment of the present invention comprises, during dialysis treatment of a dialysis patient, a dialysis monitoring device 400 equipped with an artificial dialyzer as shown in FIG. 3, a dialysis fluid supplying device 200 for supplying dialysis fluid to the dialysis monitoring device 400, dialysis drug dissolving devices 700A and 700B for supplying dialysis stock fluid to the dialysis fluid supplying device 200, an RO water generating device 600 for supplying RO water to the dialysis drug dissolving devices 700A and 700B and the dialysis fluid supplying device 200 via an RO water supply path W, a drainage path D for discharging the dialysis fluid used in the dialysis monitoring device 400, and The present invention is incorporated into an existing dialysis system 1 that is equipped with and operates in a conventional manner, and during cleaning and sterilization, the present invention is configured with a sodium hypochlorite tank 300 that supplies sodium hypochlorite to the dialysis fluid supplying device 200 through a sodium hypochlorite suction port 230 of the dialysis fluid supplying device 200 as shown in FIG. 4, and an acid injection device 100 having an acid tank 120 that supplies acetic acid to the dialysis fluid supplying device 200 through a sample port 260 for liquid B of the dialysis fluid supplying device 200 that samples a test solution obtained by diluting a dialysis stock solution made of liquid B in the dialysis fluid supplying device 200. The acid injection device 100 is configured to mix and dilute the dialysis stock solution made of liquid B with RO water. The acid injection control unit 110 controls the injection amount and injection timing of sodium hypochlorite and acetic acid to switch between adjusting the pH of the cleaning and sterilizing solution to the alkaline side and the acid side within the dialysis wastewater standard (pH 5 to 9). This allows the system to be easily attached to the dialysis fluid supplying device 200 without significantly changing the installation layout or installation space of the existing dialysis system 1. In addition, the system can easily switch between preparing the dialysis fluid and preparing the cleaning and sterilizing solution by sharing the RO water supplied to the dialysis fluid supplying device 200, and can adjust the pH to the dialysis wastewater standard of pH 5 to 6.5. When a cleaning and sterilizing liquid made of a slightly acidic hypochlorous acid aqueous solution is selected, calcium carbonate adhering to the piping and the like in the dialysis monitoring device 400 can be effectively washed and removed, and when a cleaning and sterilizing liquid made of a 30 to 600 ppm sodium hypochlorite aqueous solution whose pH has been adjusted to a pH of 6 to 9 within the dialysis wastewater standard is selected, not only can the concentration of chloride ions be high and protein adhering to the piping and the like in the dialysis monitoring device 400 be effectively washed and removed, but also the used cleaning and sterilizing liquid can be discharged into the drain within the range of the dialysis wastewater standard, and the effects are enormous. In the cleaning and sterilization shown in FIG. 4, an example has been shown in which acetic acid is supplied into the dialysis fluid supplying apparatus 200 via the sample port 260 for solution B, which is used to collect a test sample of the dilution solution B in the dialysis fluid supplying apparatus 200. However, acetic acid may be supplied into the dialysis fluid supplying apparatus 200 via the sample port 270 for solution B, which is used to collect a test sample of the dialysis fluid in the dialysis fluid supplying apparatus 200. [Explanation of symbols]

[0070] 1. Dialysis system 100... Acid injection device 110 Acid injection control section 120 Acid tank 130 Acid pump 140 Back pressure check valve 140A... Acid supply path 150 ··· Safety valve 150A··· Reduction flow path 200 ··· Dialysate supply device 210 Dialysis fluid supply control unit 220A··· First flow path 220 ··· Water receiving solenoid valve 221 ··· Water receiving solenoid valve open detection sensor 230A... Second flow path 230 ··· Sodium hypochlorite suction port 240 ··· Sodium hypochlorite solenoid valve 241 ··· Sodium hypochlorite solenoid valve open detection sensor 250 ··· Sodium hypochlorite pump 260A... 3rd flow path 260 Sample port for B solution 270 ··· Sample port for dialysis fluid 300 ··· Sodium hypochlorite tank 400... Dialysis monitoring device 410 ··· Artificial dialysis machine (dialyzer) 500...Flowmeter 600...RO water generator 700A··· Dialysis drug dissolving device (liquid A) 700B ··· Dialysis drug dissolving device (B solution) 800... drain A: Supply path for additive concentrate (liquid A) B: Supply line for dialysis solution (solution B) D...Drainage channel F... Dialysate supply path P...dialysis patient W...RO water supply line S1...Receiving water flow rate signal S2: Intake solenoid valve open detection signal S3: Sodium hypochlorite solenoid valve open detection signal S4: Equivalent signal S5 Acid pump drive signal a...RO water generator b Dialysis fluid supply device (central) c Dialysis monitoring device (console) d Sodium hypochlorite tank e. Acid tank f...neutralization tank g...Drain port h Hypochlorous water production device h1: Liquid delivery pump i... Automatic valve for RO water j Automatic valve for cleaning and sterilizing liquid

Claims

1. A cleaning and sterilization mechanism for a dialysis system, which is provided with a dialysis monitoring device to which an artificial dialyzer is attached, a dialysis fluid supplying device which supplies dialysis fluid to the dialysis monitoring device, a dialysis drug dissolving device which supplies two types of dialysis stock solutions for preparing the dialysis fluid to the dialysis fluid supplying device, respectively, an RO water supply line which supplies RO water to the dialysis drug dissolving device and the dialysis fluid supplying device, respectively, and a drainage line which discharges the dialysis fluid used in the dialysis monitoring device, a sodium hypochlorite tank for supplying sodium hypochlorite to the dialysis fluid supplying device through a sodium hypochlorite suction port of the dialysis fluid supplying device, and an acid tank for supplying an acid to the dialysis fluid supplying device through a sample port of the dialysis fluid supplying device for sampling a test of the dialysis fluid or a dilution solution obtained by diluting one of the two types of dialysis stock solutions supplied into the dialysis fluid supplying device, The cleaning and sterilization mechanism of a dialysis system, characterized in that the acid injection device has an acid injection control unit that switches between adjusting the pH of the cleaning and sterilizing solution to the alkaline side or the acid side within the sewage removal standard by controlling the injection amount and injection timing of the sodium hypochlorite and the acid that are mixed and diluted with the RO water.

2. 2. The cleaning and sterilizing mechanism for a dialysis system according to claim 1, wherein an acid injection control unit of the acid injection device is connected to a dialysate supply control unit in the dialysate supply device.

3. 3. The cleaning and sterilization mechanism for a dialysis system according to claim 1, wherein the acid injection control unit of the acid injection device is connected to a flow meter provided in an RO water supply line that supplies RO water to the dialysis fluid supply device.

4. 3. The cleaning and sterilization mechanism for a dialysis system according to claim 1, wherein the acid injection control unit of the acid injection device is connected to a sodium hypochlorite solenoid valve open detection sensor in the dialysis fluid supply device.

5. 3. The cleaning and sterilization mechanism for a dialysis system according to claim 1, wherein the acid injection control unit of the acid injection device is connected to an RO water solenoid valve open detection sensor in the dialysis fluid supply device.

6. 2. The acid injection device used in the cleaning and sterilization mechanism of the dialysis system according to claim 1, characterized in that it comprises: an acid pump for delivering acid supplied from the acid tank; a back pressure check valve interposed between the acid pump and the sodium hypochlorite suction port of the dialysis fluid supplying device; an acid supply path piped downstream of the back pressure check valve and connectable to the sample port side; and a safety valve provided in a reduction path directly connecting the acid supply path to the acid tank.

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