JP2001353214A - Dialysis system - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a dialysis system with superior operability and economic efficiency and enabling a good quality dialysis treatment causing no pollution with bacteria and an endotoxin. SOLUTION: In this dialysis system composed of a purified water manufacturing device for obtaining purified water by purifying raw water with a reverse osmotic membrane, a dialysis fluid supply device for manufacturing a prescribed dialysis fluid by adding a dialysis undiluted agent to the purified water manufactured by the purified water manufacturing device and a dialysis monitor for dialyzing blood by the dialysis fluid compounded by the dialysis fluid supply device, the dialysis system on and after a dialysis undiluted agent-added part is provided with a dialysis fluid line chlorine type sterilizing agent injector for sterilizing bacteria in an effective chlorine concentration not less than 300 ppm and a purified water line sterilizing agent adding device in a purified water line on the upstream side of the dialysis undiluted agent-added part.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

TECHNICAL FIELD The present invention relates to dialysis treatment,
The present invention relates to a dialysis system for preparing a highly clean dialysate, and particularly to a sterilization technique after dialysis treatment. For more details, it is possible to supply clean dialysis fluid at low cost, without causing corrosion or other adverse effects on dialysis system components, and without causing medical safety problems due to residual sterilant, free of bacteria and endotoxin contamination. The present invention relates to a dialysis system.

[0002]

2. Description of the Related Art FIG. 3 is a flowchart showing a general dialysis system. Raw water A (generally tap water) is subjected to a purified water production apparatus B (generally a reverse osmosis purified water production apparatus) to remove impurities and foreign substances in the raw water A to obtain purified water C. Most of the purified water C is sent to the dialysate supply device D,
A part is also supplied to the A powder melting device E or the B powder melting device F. The dialysate G thus produced passes through the dialysis monitoring device H and contacts the blood J from the patient through the dialysis membrane (not shown) in the dialyzer I to purify the blood. The waste dialysate containing waste matter transferred from the blood in the dialyzer I is discharged again through the dialysis monitoring device H. In the monitoring device H for dialysis, the amount of water removed from the blood side, the pressure of blood, and the like are monitored by the dialyzer I. The purified water C may also be sent to the personal supply device K, but the personal supply device K includes the dialysate supply device D and the dialysis monitoring device H.
, And will not be described in detail.

FIG. 4 is a flowchart showing an example of a purified water producing apparatus A. To explain the basic operation, the raw water A is subjected to ion exchange of the hardness component in the water softener 1 and then to the activated carbon filter 2.
Then, the residual chlorine is removed, and the pressure is raised to a predetermined pressure by the RO pump 3 and supplied to the RO module 4. The RO module 4 is composed of an element part made of a reverse osmosis (RO) membrane and a casing that houses the element part. Purified water that has been purified through the reverse osmosis membrane to remove various ions, fine particles, bacteria, and endotoxin is purified water tank 5
Stored in On the other hand, the concentrated water in which impurities such as salts are concentrated is partially drained, but most is returned to the RO pump 3 again in order to maintain the liquid flow rate in the RO module 4. The purified water stored in the purified water tank 5 is supplied as purified water C to a downstream device via a supply pump 6. An endotoxin removal filter 7 may be installed in the middle of the supply pump. On the other hand, a soft water line 8 that bypasses the RO module 4 from the activated carbon filter 2 so that the dialysis treatment can be continued even if an abnormality occurs in the RO pump 3 or the like.
If the soft water line valve 9 is opened, aseptic soft water can be supplied to the purified water line via the sterilization filter 10.

FIG. 5 is a flowchart showing an example of a conventional dialysate supply device D. The purified water C sent from the purified water production device A is supplied to the supply water pump 21, the heater 22, and the degassing cylinder 23.
Is supplied to the dialysate preparation tank 24a or 24b. The heater 22 is for raising the temperature of the purified water to near the body temperature of the patient. The degassing cylinder 23 is for removing excess dissolved oxygen in advance so that the gas dissolved in the purified water C in the dialyzer I does not become apparent and lower the dialysis efficiency. It is connected to a vacuum pump (not shown) through a degassing membrane. The dialysate preparation tanks 24a and 24b are alternately operated and operated. However, from the A powder dissolution apparatus E via the A liquid pump 25, and from the B powder dissolution apparatus F via the B liquid pump 26, the preparation tanks 24a and 24b Two kinds of dialysis stock solution are supplied to 24b (sometimes supplied as a powder). On the way, there is a switching valve (not shown) for alternately switching the two series of mixing tanks 24a and 24b. The three kinds of liquids including the purified water C are mixed at a predetermined ratio in the mixing tanks 24a and 24b so as to have a predetermined concentration, and are transferred to the dialysate reservoir 27 when it is confirmed that they have a normal composition. You. Next, the prepared liquid is sent as the dialysate G to the subsequent dialysis monitoring device H by the dialysate pump 28, and is used for treatment of the dialysis patient. The alternate switching of the mixing tanks 24a and 24b, the determination of the quality of the mixing result, the temperature control by the heater 22, and the like are monitored and controlled by the dialysate mixing control device 29.

The dialysis fluid preparation tanks 24a and 24b are provided with a dialysis fluid line sterilizer pump 31 from a sterilization fluid reservoir 30.
And the sterilizing agent is supplied through this.
Generally, a 5% aqueous sodium hypochlorite solution is used as the sterilizing agent, but is not limited thereto. When the dialysis treatment for all patients is completed, the supply of the undiluted dialysis solution is stopped while the purified water is still flowing, and the dialysate is replaced with the purified water in about 30 minutes. Thereafter, the sterilizing solution is supplied from the sterilizing solution reservoir 30 so that the effective chlorine concentration after the dialysate preparation tanks 24a and 24b becomes 300 to 300.
The sterilized liquid is supplied by a sterilized liquid pump 31 so as to obtain a sterilized liquid of 1,500 ppm. The prepared sterilized liquid is supplied to the dialysate line, and sterilizes piping and devices subsequent to the dialysate preparation tanks 24a and 24b including the subsequent dialysis monitoring device H. After passing the sterilizing liquid for about 30 minutes, the pump 31 is stopped, and the remaining sterilizing liquid is discharged. Then, the pump 31 is washed again with only purified water. However, sufficient time such as about 30 minutes is applied so that residual chlorine does not remain. . Because even a trace amount of chlorine below 1 ppm level is mixed in the dialysate at the time of dialysis treatment,
This is for destroying red blood cells of a dialysis patient. Chlorine persistence, even in trace amounts, is critical for patients with reduced hematopoietic capacity to receive dialysis treatment every other day.

[0006] With the development of dialysis treatment techniques, higher levels of cleanliness have been required. That is, a component having a higher molecular weight than the uretoxin component is found by removing the conventional dialysis therapy, and it is necessary to remove a substance having a larger size from the blood. For example, the pore size of a dialysis membrane called HPM (high performance membrane) is required. (Pore size)
Large dialysers have begun to be used. However, this means that there is a high risk that impurities in the dialysate, which were conventionally blocked by the dialysis membrane, are mixed into the blood side. In addition, online HDF, a therapy that actively removes blood plasma components from blood and replenishes the blood with an equivalent amount of replacement fluid to the blood, purifies the dialysate cleanly to produce a replacement fluid near the patient. It is beginning to spread.

For this reason, the dialysate is required to have a higher degree of cleanliness than before. However, not only bacteria in the dialysate but also endotoxins derived from gram-negative bacteria, which is a kind of bacteria, have become a problem. Endotoxin is a general term for a toxin component that causes fever, which is symptomatically called pyrogen. Although gram-negative bacteria are not particularly dangerous bacteria, endotoxins produced by exfoliating from cell walls when they are metabolized or killed are very difficult substances to handle. When a large amount of endotoxin is contaminated in the body, it causes a decrease in blood pressure and fever in the patient, and in severe cases, puts the patient's life at risk.
In addition, chronic damage due to finely divided fragments of this endotoxin has been pointed out. This is a significant problem for dialysis patients who must receive 10-15 hours of treatment each week for their lifetime, given the chronic disease of long-term treatment for decades.

The minimum molecular weight of this fragment is 5,000
0 daltons, which corresponds to the size (molecular weight) of the uretoxin component to be removed from the patient, which is well permeable to dialysis membranes (eg, dialysis membranes that allow 50,000 daltons of material to permeate) Is also used). Therefore, in order to safely perform such a high-performance dialysis treatment, the number of endotoxins in the dialysate must be minimized.

For this reason, various studies have been made to prevent endotoxin from being produced in the dialysate line. However, since the dialysate contains abundant nutrients, bacteria easily propagate, and as a result, endotoxin is easily produced. Therefore, conventionally, a method of sterilizing a dialysate line has been studied based on a very common concept that "endotoxin is generated in a dialysate line". Currently, generally 30 days after dialysis treatment,
Sterilization is performed with chlorine having a high concentration of 0 to 1,500 ppm. However, since the generation of endotoxin still cannot be suppressed, some drugs such as peracetic acid are used (for example, see the 42nd Japan Dialysis Medical Association Magazine “P-13”).
1)), in addition to being a very expensive drug, there is also a suggestion that there is still a limit to the reduction of endotoxin by itself (for example, the 42nd Annual Meeting of the Japanese Society for Dialysis Medicine “O-108”).
4 "). In addition, a new electrolytic water production technique has been proposed, such as a strong acid water generator, in which a solution containing sodium chloride is electrolyzed to generate hypochlorous acid having a sterilizing effect (for example, The 41st Japan Dialysis Medical Association Magazine "W-10-1"), in medical treatment where the equipment is expensive and hypochlorous acid flows under acidic conditions, causing leakage of current due to corrosion of piping such as heaters. It has fatal issues that must be avoided, and there are indications that its effects may be questioned (for example, the 41st Japan Dialysis Medical Association Magazine O-2
45 "). In addition, the hypochlorous acid concentration in the strongly acidic water is low, so the hypochlorite which is indispensable for the decomposition of glucose which is inevitably present in the dialysate and the protein component from the patient which is excluded into the dialysate through the dialysis membrane is used. There is also a problem that acid is consumed and available chlorine remaining for sterilization is not enough.

[0010] On the other hand, it has been reported that even if the dialysis fluid line is adequately managed, 90% or more of endotoxin is derived from RO purified water (for example, the 43rd Dialysis Medical Association Magazine “P.
-360 "). It is pointed out that the biggest factor is endotoxin contaminated from raw water containing a large amount of endotoxin due to micro leak caused by physical fatigue of RO module (for example, “Dialysate Water Quality Management & Online”). HDF "(Medical Review). In response to this, the present inventors have filed Japanese Patent Application No. 9-28.
No. 7703 proposes a technique for greatly reducing the physical fatigue of an RO module. As a result, good purified water can be obtained, but there is still a problem in stably obtaining higher purified water.

[0011] Gram-negative bacteria such as Pseudomonas aeruginosa, which release endotoxin, are not special bacteria but are resident bacteria that live in general living environments. Therefore, it grows easily in a dialysate line rich in nutrients. However, the inventor
It was confirmed that the growth in the dialysate line, which had been the subject of the conventional research, was suppressed as long as it was surely sterilized after each dialysis. That is, as long as the dialysate line is correctly sterilized, most of the endotoxins detected in the dialysate line are derived from the upstream side, and are derived from the RO purified water that is the mother liquor of the dialysate preparation. Is big ". In addition, endotoxin derived from RO purified water is generated in large quantities even if RO membrane leaks are checked conventionally and the generation of retained water in the RO device is prevented by constantly circulating purified water. I found something. As a result of further research, they found that "this is because low-concentration oligotrophic bacteria live in the RO purified water line."

[0012] That is, since the RO membrane removes not only organic nutrients but also various ionic components in raw water, it has been considered that bacteria are difficult to propagate in RO purified water. Therefore, the RO purified water line was hardly sterilized because the RO membrane itself could not withstand chlorine sterilization. However, there are bacteria that live in an oligotrophic environment such as pure water including RO purified water, and we are one of them, "Pseudomonas stutzeri."
2 ". In addition, this bacterium is a "gram-negative glucose non-fermenting bacillus", and in the RO purified water line represented by the oligotrophic environment, there are many gram-negative bacilli that generate endotoxin (for example, "membrane treatment technology"). Taikei Vol.2 (Fuji Techno System)). Further, as a result of raising the temperature of the RO purified water by the heater 22 in FIG. 5, a suitable temperature environment of 20 to 30 ° C. where bacteria grow is given, and it is found that the water is growing (for example, “industrial water”).
No. 345).

[0013]

In order to solve the above-mentioned problems, high-concentration chlorine sterilization, which is currently performed in the dialysate line into which the dialysis base material is injected, is performed from the upstream RO purified water line to increase the proliferation. Although it can be suppressed, conventionally, this fact was not regarded as important, and it could not be implemented because of the following problems. (1) Many heaters, degassing membranes, and the like installed in the RO purified water line cannot withstand a high concentration of a chlorine sterilant. If the heater erodes, it can lead to serious accidents that must be avoided for medical devices, the generation of leakage current. (2) As shown in FIG. 3, RO purified water is supplied not only to the dialysis fluid supply device D but also to various devices. Was not synchronized (rather than noticing the importance of RO purified water line sterilization, so that it was not necessarily designed to sterilize except the dialysate line). Therefore, the sterilant injected into the RO purified water line may be mixed into a device other than the dialysate supply device D, leading to a serious medical accident of hemolysis of the patient's blood.

[0014] Accordingly, an object of the present invention is to provide a method in which a site inhabiting many endotoxin-producing Gram-negative bacteria is:
By discovering that it is located at a site other than the site that has been conventionally considered, the present invention provides a completely novel sterilization technique for effectively suppressing this. Furthermore, by providing a high-performance sterilization technology that is inexpensive, does not cause adverse effects such as corrosion on constituent members, and does not cause medical safety problems due to the remaining sterilant, operability and economy are higher than before. An object of the present invention is to provide a dialysis system which is capable of performing high-quality dialysis treatment free of bacteria and endotoxin contamination.

[0015]

In order to achieve the above object, the present invention employs the following constitution. That is, (1) a purified water producing apparatus for purifying raw water by a reverse osmosis membrane to obtain purified water, and a dialysate is added to purified water produced by the purified water producing apparatus to produce a predetermined dialysate. In a dialysis system comprising a dialysis fluid supply device and a dialysis monitoring device for performing hemodialysis with the dialysis fluid prepared by the dialysis fluid supply device, the dialysis system after the site where the dialysis base material is added is treated with available chlorine. A dialysis fluid line that sterilizes at a concentration of 300 ppm or more is provided with a chlorine-based sterilant injecting device, and a purified water line upstream of the site where the dialysis base material is added is provided with a purified water line sterilant adding device. And dialysis system.

(2) The dialysis fluid line chlorine-based sterilant injection device and the purified water line sterilant addition device operate upon receiving a sterilization permission signal from the dialysis system using the purified water and dialysate. When the dialysis fluid line chlorinated sterilant injection device and the purified water line sterilant addition device are operating, a predetermined operation is performed on the dialysis system using the purified water and the dialysate. The dialysis system according to the above (1), wherein the dialysis system is adapted to emit a signal for causing the dialysis.

(3) The sterilant to be injected into the dialysate line is an aqueous sodium hypochlorite solution, and the apparatus for adding a sterilant to a purified water line has an effective chlorine concentration of 20 per week.
The dialysis system according to the above (1), wherein the sodium hypochlorite aqueous solution is injected so as to be not more than ppm × time.

[0018]

BEST MODE FOR CARRYING OUT THE INVENTION As a result of diligent investigation, the present inventors have focused on the following characteristics of this RO purified water line and the bacteria living therein, and have reached the present invention. (1) It was found that the growth rate of oligotrophic bacteria inhabiting the RO purified water line was slow and, unlike the bacteria in the dialysate line, required several days for growth. Therefore, unlike the dialysis solution line, daily sterilization is not always required, and even a weekly sterilization can exert a sufficient effect. Accordingly, washing with RO purified water for purging chlorine after sterilization can be carried out when there is sufficient time before the next dialysis, for example, on Saturday, etc., rather than between strict daily schedules. . (2) The dialysate line contains a large amount of chlorine-consuming organic substances such as glucose. After dialyzer I, it contains waste protein produced by the patient and, in some cases, hepatitis B virus. Therefore, high-concentration chlorine injection is required. However, the RO purified water line has few contaminants that consume chlorine other than bacteria (thus causing oligotrophs to propagate). Furthermore, the oligotrophic bacteria are easily killed by low-concentration chlorine sterilization.

[0019]

[First Embodiment] FIG. 1 is a flow chart showing a first embodiment of a dialysate supply apparatus according to the present invention. Feed water pump 21, heater 22, deaeration cylinder 23,
Dialysate preparation tanks 24a and 24b, solution A pump 25, B
The functions of the liquid pump 26, the dialysate storage tank 27, the dialysate pump 28, the dialysate preparation control device 29, the sterilant storage layer 30, and the dialysate line sterilant pump 31 and their interrelation are the same as those in FIG. A 5% sodium hypochlorite solution is stored in the sterilant storage layer 30, but is not limited thereto as long as it is a chlorine-based sterilant. In the present invention, a purified water line sterilant pump 51 is further provided, and the concentrated sodium hypochlorite solution in the sterilant reservoir 30 is injected into the injection point 52 of the purified water C line.
Although the two sterilant pumps 31 and 51 are both metering pumps, their operation timing is controlled by electric signals 54 and 55 from a sterilization / washing control device 53. The purified water C is also branched upstream of the injection point 52 into the A powder dissolving device E, the B powder dissolving device F, and the personal dialysis device K, as shown in FIG.

Next, the operations of the sterilizing agent pumps 31 and 51 and the sterilizing and washing control device 53 will be described. When the dialysis system enters the sterilization / washing process, a signal from the sterilization / wash control device 53 is transmitted as an electrical signal 56 to the dialysate preparation control device 29, and the dialysate preparation control device 29 transmits the A solution pump 25 and the B solution Pump 26
Is stopped to stop supplying the undiluted dialysis solution to the preparation tanks 24a and 24b, the heater 22 is turned off, and a predetermined sterilization and washing operation is started. Specifically, as a pre-water washing step, the dialysate in the dialysate line is expelled in 30 minutes and replaced with RO purified water. At this time, the sterilant pump 51 is also operated, and sodium hypochlorite solution is injected from the reservoir 30 so that the available chlorine concentration after the injection point 52 becomes 2 ppm, and oligotrophic bacteria including the heater inhabit. Sterilize potential purified water lines. This low concentration chlorine solution is also supplied to the dialysate line. Although some dialysate still remains in the dialysate line, there is no particular problem because the chlorine concentration is low.

When the replacement of the RO purified water is completed, the sterilant pump 51 is stopped, and the sterilant pump 31 is operated instead.
As a result, the concentration of chlorine becomes as high as 300 ppm after the mixing tank 24, and the eutrophic bacteria line which was in the dialysate environment is sterilized. At the same time, proteins mixed in the dialysate line from the dialyzer through the membrane (the source of bacterial growth) are also decomposed by chlorine. After the high-concentration chlorine sterilization is performed for about 30 minutes, the sterilant pump 31 is stopped again, and the water washing step is performed for about 30 minutes using only RO purified water. Further, before the start of the dialysis treatment on the next day, it is washed with water for about 30 minutes, and after confirming that there is no residual chlorine, the dialysis treatment is performed again.

In the above embodiment, the sterilant pump 51
The concentration of chlorine added to the RO purified water line is 2/300 of the sterile chlorine concentration after the dialysate line, that is, 1
It is 1/50, and does not adversely affect the heater 22, the degassing cylinder 23, and the like. In addition, various peripheral devices E
There is a possibility that chlorine may be partially mixed into the F · K due to diffusion. However, since the chlorine concentration is low, the amount is very small, and may be replaced with RO purified water again at the time of post-water washing. No problem. Even if these peripheral devices E, F, and K use purified water without synchronizing with the dialysate supply device, slight post-water washing is performed because the chlorine concentration is very small and the addition time is short. Then there is no concern about chlorine residue.

Further, the present invention exhibits a new effect. In the above example, the RO purified water line was sterilized every day. However, the lines other than the dialysate line were not in a eutrophic environment, and were not always in favorable conditions for bacterial growth. Therefore, even if oligotrophs inhabit, their growth rate is very slow. Thus, the sterilization of the dialysate line is performed every day or every time the dialysis treatment is completed. However, the sterilization of the RO purified water line may be performed once a week, for example, on Saturday when a sufficient time for washing can be obtained.

In this case, the “chlorine concentration × time” exposed during one week should be the same level as that when sterilized every day or slightly higher than about 40 ppm × 30 minutes or less (about 20 ppm × hour or less). And more preferably 2
0 ppm × 30 minutes or less. The specific concentration is determined according to the environment in which the dialysis system is installed, but the chlorine concentration when sterilized every day (for example, 2 ppm × 30 minutes ×
6 days) is slightly higher, because non-sterilized
During the day, even a small amount of bacteria grows, because the total amount of bacteria to be sterilized is increasing. This eliminates the need to check the residual chlorine concentration after sterilization of the RO purified water line every day, and at the same time does not use expensive RO water for sterilization and post-washing.

Next, a clinical use example in which the above-described apparatus is used in a dialysis system in a certain hospital will be described with reference to data. In the dialysis system, various agents such as peracetic acid have been studied as a chlorine-based sterilant for the dialysate line. However, despite the fact that the endotoxin from the purified water production apparatus B is at a level of "very good" of 8 to 22 EU / L, the endotoxin from the dialysate supply apparatus and the monitoring apparatus for dialysis is 7 to 7
The level was "bad", ie, 00 to 1,100 EU / L. Therefore, sodium hypochlorite solution was injected for 30 minutes every Saturday using the method and apparatus of FIG. 1 so that the chlorine concentration in the purified water line became 20 ppm. On the other hand, after each treatment, sodium hypochlorite solution is injected for 30 minutes so that the effective chlorine concentration of the dialysate line becomes 300 ppm by a conventionally performed method, and after completion of sterilization, predetermined post-water washing is performed for 30 minutes. Carried out.

As a result, two weeks after the start of the infusion, the dialysate supply device and the dialysis monitoring device were both set to 10-2.
Dramatically improved to a level of "very good" of 0 EU / L. This is almost the same level as the above-mentioned level of RO purified water of 8 to 22 EU / L. After confirming that this good condition was obtained over a period of two months, all of the RO modules in the purified water producing apparatus B were exchanged, and low concentration chlorine injection was carried out every Saturday. As a result, over several months, the endotoxin level in the entire range from the purified water producing apparatus to the dialysis monitoring apparatus was able to reach a level that is below the detection sensitivity to 4 EU / L, which is the "ideal target value". . From this, it was found that if the dialysate supply device was accurately sterilized and endotoxin was not brought in from the purified water production device, a very good cleanness could be obtained by implementing the present invention. Conversely, it means that no matter how good the dialysate supply device or purified water production device alone is, a “good dialysis system” cannot be obtained by itself. [Second Embodiment] Another embodiment will be described with reference to FIG. In FIG. 2, there is no special one shown in FIG. 1 as the purified water line sterilant pump 51. Instead of this, a sterilizing agent pump 131 instead of 31 includes a metering pump capable of switching the flow rate to two or more stages by an electric signal, and a three-way switching solenoid valve 141 installed in its discharge line. One of the switching valves is connected to the pair of dialysate preparation tanks 24 by a line 142 as in FIG. 1, while the other is newly provided via a line 143 to the supply water pump 21.
Is connected to the purified water line C at an injection point 52 upstream of The sterilization / cleaning control device 144 corresponds to 53 in FIG. 1, but the electric signal 145 further includes a flow rate setting signal for the sterilant pump 131. The control device 144 also sends an electric signal 1 to the switching solenoid valve 141.
46 is transmitted.

Next, the sterilant pump 131 and the switching solenoid valve 14
1. The operation of the sterilization / cleaning control device 144 will be described. When the washing is started before the sterilization, the sterilizing agent pump 131 is set to the low flow rate by the electric signal 145. At the same time, the switching solenoid valve 141 is switched to the line 143 side by the electric signal 146, so that the sodium hypochlorite solution is injected from the reservoir 30 so that the chlorine concentration of the purified water line after the pump 21 becomes 2 ppm. . Thirty minutes later, when the pre-washing step is completed and the sterilization step is started, the valve 141 is switched to the line 142.
Side, the sterilant pump 131 is switched to the high flow side,
300 ppm of dialysate line after dialysate is added
Sterilize with sodium hypochlorite. This enables a dialysis system according to claim 1 of the present invention with one sterilant pump.

It is not necessary that the chlorine concentration in the purified water line at the time of pre-washing be 2 ppm in a stable manner.
It is sufficient that an integrated value of 30 minutes is obtained.
The operation amount (discharge interval) may be changed without changing the discharge amount during the dialysate line injection. Because the sterilization effect is not simply a function of the concentration, but of the integrated value of concentration × time, the sterilant pump does not necessarily have to be an expensive pump having a continuous and constant flow rate.

This makes the present invention more effective. In the purified water producing apparatus B of FIG. 4, if the endotoxin removal filter 7 is provided, endotoxin mixed into the purified water line by the RO membrane leak can be prevented irrespective of a slight deterioration with time of the RO membrane. In this case, the present invention is very effective. The low-concentration chlorine supply line 143 is connected to a purified water line on the upstream side of the filter 7. This is because the filter 7 is often composed of a hollow fiber bundle having a large surface area and a pore size of about 0.01 μm. However, on the surface of this hollow fiber, to simultaneously capture oligotrophic bacteria coming from the RO module,
This proliferates and produces endotoxin. Also, on the secondary side of the hollow fiber, bacteria grown on the downstream side may flow back and grow when the device is stopped. Therefore, the filter 7 for removing endotoxin brought in from the upstream side,
There is a danger of becoming a source of endotoxin.
Therefore, even if it has good endotoxin inhibition performance at normal times, for example, when unexpected pressure shock or vibration was applied or when the hollow fiber was cut even partially, it had accumulated and produced by then. It can release large amounts of endotoxin at once, creating a potentially dangerous condition.

In such a case, the chlorine injection point 52 to the purified water line should be upstream of the endotoxin removal filter 7 and sterilized with low-concentration chlorine after dialysis so that oligotrophs do not inhabit on the surface of the hollow fiber. Is desirable. At this time, since the filter 7 is installed in the upstream part of the apparatus using all the RO purified water, the chlorine injected into this line is supplied to all the related apparatuses, and there is a potential residual chlorine problem. I have. However, in the present invention, the chlorine concentration is only 2
ppm, and there is no problem if slight post-water washing is performed as described above.

Next, an embodiment according to claim 2 in which medical safety is further improved will be described with reference to FIG. After the dialysis is completed, the patient withdraws, and all of the dialysis monitoring devices H indicate "Start sterilization O".
When the electric signal 201 of “K” arrives and further receives the electric signal 202 of “Start sterilization OK” from the powder dissolving devices EF using the purified water C, the personal supply device K, etc., the control device 144 reverses. The electric signal 203 is transmitted to all the dialysis monitoring devices H, and the electric signal 204 is transmitted to E, F, K, etc., and the devices that share the purified water and the dialysate are synchronized and sterilized and washed. Perform the operation. Specifically, the connection to the patient is prohibited in the dialysis monitoring device H and the personal supply device K, and the dissolution operation of the dialysis drug is prohibited in the powder dissolution devices EF. Thereafter, an electric signal 156 is issued to the control device 29, and then a pre-washing step for 30 minutes and a sterilizing step for a dialysate line for 30 minutes are started. During this time, the dialysate preparation control device 29, the sterilant pump 131 and the switching valve 141 sterilize the purified water line and the dialysate line based on the respective electric signals 156, 145, and 146 coming from the control device 144. After the dialysis fluid line is sterilized for 30 minutes, the sterilant pump 131 is stopped, and a post-water washing process is started. After washing with water for a certain time (for example, 30
Minutes) After execution or when it is detected that the residual chlorine in each part has been exhausted, the operation prohibition related to the dialysis treatment for EFK is released by the electric signal 204. Next, if it is necessary to enter the dialysis step, the preparation of the dialysate is started, and when the dialysate concentration / temperature reaches a predetermined value, the dialysis monitoring device H issues a "dialysis start OK" permission signal 203.

Since a large amount of chlorine-based sterilizing agent is used in the dialysate line, sodium hypochlorite solution is desirable from the viewpoint of economy, but a small amount of sterilizing agent is injected into the purified water line. Other methods may be used. For example, instead of the sterilizing agent pump 51 of FIG. 1, an apparatus for generating electrolyzed water called so-called electrolyzed functional water may be installed. The electrolyzed water generator may be, for example, a strongly acidic water generator known in Japanese Patent No. 2,626,778. It electrolyzes raw water containing salt and produces hypochlorous acid and chlorine molecules. Alternatively, a weakly acidic water generating apparatus that generates hydrochloric acid by adding hydrochloric acid to the salt solution and electrolyzing it may be used. Further, a weak alkaline water generator which generates hypochlorous acid and ozone by electrolyzing common tap water may be used. This weak alkaline water generator is, for example, disclosed in Japanese Patent Application Laid-Open No. 9-234238. Since tap water contains chlorine ions, hypochlorite is similarly generated by electrolysis. Of course, the amount of generated acid water is smaller than that of the former two, but the gist of the present invention is to inject a small amount of chlorine into the purified water line, and there is no problem.

Further, this weak alkaline water generator can be installed upstream of the sterilization filter 10 in the soft water line of FIG. In this case, the sterilized liquid filtered by the filter 10 can be injected into the purified water line. In addition, since the dialysate also contains chloride ions, part of the dialysate that is being replaced is used as raw water for the electrolyzed water device during washing with water before the dialysate in the dialysate storage tank is replaced with purified water, and the generated electrolyzed water is used. Injection point 5
2 may be supplied. The advantage of sterilizing RO purified water with these electrolyzed waters is that these electrolyzed waters are easily decomposed over time. Therefore, the problem of chlorine residue can be further reduced.

The available chlorine in a commercially available sodium hypochlorite solution is generally hypochlorite ion (OCl
On the other hand, the forms of available chlorine generated in the above electrolyzed water generator are hypochlorous acid (HOCl) and chlorine molecules (Cl2), and the sterilization rate is said to be several tens times faster. . However, since chlorine is consumed by a trace amount of organic matter that cannot be coexisted, it is desirable that any available chlorine be chlorine having the concentration level described in the examples of the present invention. Rather, since the metal corrosivity is originally low, hypochlorite ions can be in a high concentration state (thus, it is hardly affected by the presence of a small amount of organic substances), and this is more preferable.
Considering that the sterilization time is about 30 minutes, this slow sterilization rate is sometimes not a problem.

Furthermore, as a purified water line sterilant, for example, a device for generating ozone water from RO purified water by electrolysis as disclosed in Japanese Patent No. 3001551 may be used. In this case, install the generator directly on the purified water line and turn on the power.
Since generation of ozone water can be controlled by / OFF, there is no need to install complicated piping, and convenience is improved.

Further, the sterilizing agent pump 51 can be operated again at the time of post-water washing to "retain low-concentration chlorine in the dialysis system until the next dialysis treatment". In this case, the growth of bacteria generated during the suspension period can be suppressed, and the sterilizing agent can penetrate into every corner of the system due to the diffusion effect, thereby providing safer and cleaner dialysis treatment.

Further, in FIG. 1, at the outlet of the dialysate pump 28, an entotoxin removing filter (not shown) may be installed in or attached to the dialysate supply device. Conventionally, it has been considered that "a large amount of endotoxin is generated in the dialysate line", so that an endotoxin removal filter is often installed immediately before the dialysis monitoring device at the end. That is, it is not economical because it is installed corresponding to each dialysis monitoring device, and it is difficult to hold and manage it because it is installed in the middle of the dialysate pipe (mostly a silicon tube). However, according to the present invention, "many endotoxins are generated in the purified water line"
Therefore, the upstream side is desirable as much as possible.

Further, it has been considered that "captured endotoxin accumulates because a conventional endotoxin filter is not inactivated by chlorine." For this reason, endotoxin accumulation countermeasures such as replacing the filter element periodically and purging the stagnant water on the primary side have been taken. However, according to the study of the present inventor, "endotoxin has several hundred pp
A significant portion of the chlorine is deactivated when very high levels of chlorine are encountered at m levels. " Therefore, it has been found that installing an endotoxin removal filter in the dialysate line that is sterilized every day and as upstream as possible enables the integrated management as a medical device and leads to a cleaner dialysate.

[0039]

According to the present invention, a novel sterilization method, which has the above-mentioned structure, can effectively suppress the inhabitation of many endotoxin-producing Gram-negative bacteria at sites other than those conventionally considered. It is possible to provide a high-performance sterilization technique which can provide a technique, is inexpensive, has no adverse effects such as corrosion on constituent members, and does not cause a medical safety problem due to a residual sterilant. In addition, it is possible to perform high-quality dialysis treatment free of bacteria and endotoxin contamination, which is more excellent in operability and economy than ever before.

[Brief description of the drawings]

FIG. 1 is a flowchart showing an embodiment of a dialysate supply device according to the present invention.

FIG. 2 is a flowchart showing another embodiment of the dialysate supply device according to the present invention.

FIG. 3 is a flowchart showing a general dialysis system.

FIG. 4 is a flowchart showing an example of a purified water producing apparatus A.

FIG. 5 is a flowchart showing an example of a conventional dialysate supply device D.

[Explanation of symbols]

 A: Raw water B: Purified water production device C: Purified water D: Dialysate supply device E: A powder dissolution device F: B powder dissolution device G: Dialysate H: Dialysis monitor I: Dialyzer J: Blood from patient K: Personal feeding device 1: Soft water filter 2: Activated carbon filter 3: RO pump 4: RO module 5: Purified water tank 7: Endotoxin removal filter 8: Soft water line 9: Soft water line valve 10: Disinfection filter 21: Supply Water pump 22: heater 23: degassing cylinder 24a, 24b: dialysate preparation tank 25: A liquid pump 26: B liquid pump 27: dialysate reservoir 28: dialysate pump 29: dialysate preparation control device 30: sterile liquid storage Layer 31, 51: dialysate line sterilant pump 52: chlorine injection point into purified water line 53: sterilization washing control device 56: dialysate preparation control device Electrical signal 131 to: sterilant Pump 141: switching electromagnetic valve 142, 143: Line 144: sterile cleaning control device 145,146,201～204: electrical signal

──────────────────────────────────────────────────続 き Continued on the front page (51) Int.Cl. ⁷ Identification symbol FI Theme coat ゛ (Reference) C02F 1/44 C02F 1/44 H 1/50 510 1/50 510A 520 520B 531 531P 540 540B 550 550C 560 560E 560D 560B F-term (reference) 4C058 AA12 AA17 BB07 JJ08 JJ21 JJ22 4C077 AA05 BB01 DD30 EE01 EE03 GG03 GG04 KK09 4D006 GA03 KB11 KB12 KB17 KD24 PA02 PB06 PB24 PB42 PB43 PB54 PC44

Claims (3)

[Claims] 1. A purified water producing apparatus for purifying raw water by a reverse osmosis membrane to obtain purified water, and a dialysis base material is added to purified water produced by the purified water producing apparatus to produce a predetermined dialysate. In a dialysis system comprising a dialysis fluid supply device and a dialysis monitoring device for performing hemodialysis with the dialysis fluid prepared by the dialysis fluid supply device, the dialysis system after the site where the dialysis base material is added is treated with available chlorine. A dialysis fluid line that sterilizes at a concentration of 300 ppm or more is provided with a chlorine-based sterilant injecting device, and a purified water line upstream of the site where the dialysis base material is added is provided with a purified water line sterilant adding device. And dialysis system. 2. The apparatus for injecting a chlorinated sterilant in a dialysate line and the apparatus for adding a purified water line in a sterilizing agent receive a sterilization permission signal from a dialysis system using the purified water and dialysate. As such, and while the dialysate line chlorine sterilant injection device and the purified water line sterilant addition device are operating, the dialysis system using the purified water and dialysate performs a predetermined operation. The dialysis system according to claim 1, wherein the dialysis system emits a signal. 3. The sterilizing agent to be injected into the dialysate line is an aqueous sodium hypochlorite solution, and the purified water line sterilizing agent adding device has an effective chlorine concentration of 20 ppm per week.
2. The dialysis system according to claim 1, wherein an aqueous solution of sodium hypochlorite is injected so that the time is equal to or less than x hours.