JP4400790B2 - Hemodialysis system - Google Patents

Description

  The present invention relates to a hemodialysis system capable of preparing a dialysate having a predetermined concentration and performing dialysis treatment by supplying or collecting the dialysate to a blood purification means.

  In dialysis treatment, usually, blood for collecting dialysate containing waste products etc. in blood removed by blood purification means while supplying a predetermined concentration of dialysate to blood purification means such as dialyzer. A dialysis system is used. Such a hemodialysis system includes two dialysate solutions (A drug stock solution and B drug stock solution) dissolved in clean water to prepare a dialysate solution having a predetermined concentration, and the prepared dialysate solution on the blood purification means side. And the dialysate flow path for guiding the dialysate collected from the blood purification means to the waste fluid means side, and the conductivity of the dialysate to detect whether the prepared dialysate has reached a predetermined concentration. It is mainly composed of a conductivity measuring means (such as a conductivity meter) for measuring.

  By the way, for example, a disinfection process for supplying and circulating a chlorine-based disinfectant cleaning agent such as sodium hypochlorite to the dialysate flow path, and an acid cleaning process for supplying and circulating an acid cleaning agent such as an acetic acid aqueous solution to the dialysate flow path By regularly implementing the above, hygiene of the hemodialysis system is maintained for a long time. Thus, in the disinfection process, disinfection and protein removal are achieved with a chlorine-based disinfectant cleaning agent, and in the acid cleaning process, calcium carbonate and the like precipitated due to the components of the dialysate are removed. .

However, if the chlorine-based disinfectant used in the disinfection process or the acid detergent used in the acid cleaning process is directly introduced into the waste liquid means and discharged as wastewater, it will have an adverse effect on the environment. Various proposals have been made to prevent this. For example, as disclosed in Patent Document 1, conventionally, it has been proposed to add a reducing agent after the disinfection process and to make the waste liquid by detoxifying the chlorine-based disinfectant cleaning agent with the reducing agent. It had been.
Japanese Patent Laid-Open No. 64-11552

  However, the conventional hemodialysis system has a problem that it is impossible to monitor whether the chlorine-based disinfectant detergent is detoxified (inactivated) or not. That is, even if a predetermined amount of reducing agent is added after the disinfection step, the chlorine-based disinfectant cleaning agent may not be deactivated satisfactorily due to, for example, malfunction of the apparatus or changes in conditions. For example, there is a problem that simple discrimination cannot be performed.

  In addition, in order to solve the above problems, for example, a pH meter is equipped to monitor the pH value after the disinfection process or the acid cleaning process, and the inactivation of the chlorine-based disinfectant cleaning agent, acetic acid, etc. is performed well. However, in this case, it is necessary to install a new pH meter, which increases the manufacturing cost of the hemodialysis system and deteriorates workability as the number of maintenance elements increases. There are problems such as.

  Therefore, the present applicant has found that the electrical conductivity increases or decreases with changes in the pH value of the solution used in the disinfection process, the acid washing process, etc., and the electrical conductivity measurement that is essential for the hemodialysis system. It was studied to use the means (conductivity meter) for pH monitoring of waste liquid after disinfection or acid cleaning.

  The present invention has been made in view of such circumstances, and inactivates disinfectants, acid detergents, etc. contained in waste liquid while suppressing an increase in manufacturing cost of the apparatus and deterioration in maintenance workability. It is an object of the present invention to provide a hemodialysis system capable of monitoring whether or not it is planned.

According to the first aspect of the present invention, the dialysate preparation means capable of preparing a dialysate having a predetermined concentration, and the dialysate prepared by the dialysate preparation means are guided to the blood purification means side and recovered from the blood purification means. A dialysate flow path for guiding the dialysate to the waste liquid means side, a conductivity measuring means for measuring the conductivity of the dialysate flowing through the dialysate flow path to detect the concentration of the prepared dialysate, and a closed state. Supplying an alkaline alkaline detergent, an inactivating agent that deactivates the alkaline detergent to be acidic or neutral, and performs an alkaline washing step, an acid washing step, or a neutralization step A hemodialysis system comprising a supply means, wherein the pH state in the dialysate flow path is monitored based on the conductivity measured by the conductivity measurement means during the washing or neutralization step by the supply means Said dialysis fluid flow Characterized by monitoring the pH condition of the dialysate flow path during cleaning or neutralization step by the supply means to divert the conductivity measuring means for measuring the conductivity of the dialysate flowing in the.

  According to a second aspect of the present invention, in the hemodialysis system according to the first aspect, the supply means supplies a chlorine-based disinfectant cleaning agent to perform an alkali cleaning step, and then supplies an inactivating agent to make it acidic. An acid cleaning agent is used, and an acid cleaning process is performed.

  The invention according to claim 3 is the hemodialysis system according to claim 2, wherein the supplying means supplies an inactivating agent after the acid washing step to perform a neutralization step.

  According to a fourth aspect of the present invention, in the hemodialysis system according to any one of the first to third aspects, the supply unit includes a first supply unit that supplies an alkaline detergent, and an acidic detergent. And a second supply means for supplying an inactivator capable of neutralizing the acid detergent to serve as a neutralizing agent.

  According to the first aspect of the present invention, the conductivity measuring means that is essential for the hemodialysis system is also used for pH monitoring of the waste liquid after disinfection or acid cleaning. It is possible to monitor whether or not the inactivation of the disinfectant, the acid cleaning agent, and the like contained in the waste liquid is successfully achieved while suppressing the deterioration.

  According to the invention of claim 2, the supply means supplies the chlorine-based disinfectant cleaning agent to perform the alkali cleaning step, then supplies the inactivating agent to form an acidic acid cleaning agent, and performs the acid cleaning step. In addition, since the pH state is monitored by the conductivity measuring means during the acid cleaning step, the pH in the alkali cleaning step and the pH in the acid cleaning can be continuously changed, and the pH by the conductivity measuring means can be changed. Monitoring can be performed reliably and easily, and it can be determined whether or not the acid cleaning in the acid cleaning step is reliably performed.

  According to the invention of claim 3, the supplying means supplies an inactivating agent after the acid cleaning step to perform the neutralization step, and at the time of the neutralization step, the pH state is monitored by the conductivity measuring means. Since it is performed, the pH can be continuously changed from the alkali washing step to the neutralization step, pH monitoring by the conductivity measuring means can be surely and easily performed, and neutralization in the neutralization step is ensured. It can be determined whether or not it is being performed.

  According to the invention of claim 4, the supply means uses the first supply means for supplying the alkaline cleaning agent and the alkaline cleaning agent as an acidic acid cleaning agent, and neutralizes the acid cleaning agent to neutralize the acid cleaning agent. And the second supply means for supplying an inactivating agent that can be used, the present invention can be applied as it is to an existing hemodialysis system configured to be able to supply the disinfecting solution and the acid washing solution.

Hereinafter, embodiments of the present invention will be specifically described with reference to the drawings.
As shown in FIG. 1, the hemodialysis system according to the present embodiment has a dialysate preparation means 1 capable of preparing a dialysate having a predetermined concentration and the dialysate prepared by the dialysate preparation means 1 on the dialyzer 7 side. A supply-side dialysate flow path L1, a discharge-side dialysate flow path L2 that guides the dialysate collected from the dialyzer 7 to the waste fluid means 5, a supply-side dialysate flow path L1, and a discharge-side dialysate flow path L2. Are mainly composed of a dual pump 3, a conductivity meter 4 (conductivity measuring means), and a water removal pump 6.

  The dialyzer 7 as a blood purification means is formed with a blood introduction port 7c, a blood outlet port 7d, a dialysate inlet port 7a, and a dialysate outlet port 7b in the casing, of which the blood inlet port 7c Is connected to the proximal end of an arterial blood circuit (not shown), and the blood outlet port 7d is connected to the proximal end of a venous blood circuit (not shown). The patient's blood is circulated extracorporeally in the arterial blood circuit, the dialyzer 7 and the venous blood circuit, and is purified by the dialyzer 7 in the process. A supply side dialysate flow path L1 and a discharge side dialysate flow path L2, which will be described later, are connected to the dialysate introduction port 7a and the dialysate discharge port 7b.

  A plurality of hollow fibers (hollow fiber bundles) are accommodated in the dialyzer 7, the inside of the hollow fibers is used as a blood flow path, and between the outer peripheral surface of the hollow fibers and the inner peripheral surface of the housing portion. Is a flow path for dialysate. Each hollow fiber has a number of minute pores (pores) penetrating the outer peripheral surface and the inner peripheral surface thereof to form a hollow fiber membrane, through which the waste products in the blood are dialyzed. It is configured so that it can be transmitted through and removed.

  The supply-side dialysate flow path L1 is configured such that one end side thereof is connected to the water supply means 2 to which clean water is supplied and the other end side can be connected to the dialysate introduction port 7a of the dialyzer 7, The production means 1 and the conductivity meter 4 are provided. The dialysate preparation means 1 includes stirring chambers 1a and 1b for stirring while containing a predetermined amount of dialysate in the preparation process, and an introduction line L7 that can introduce the agent A stock solution and the agent B stock solution that are stock solutions of the dialysate. L8 and introduction pumps P1 and P2 are mainly configured.

  The agent A stock solution is composed of a mixed aqueous solution containing sodium chloride, potassium chloride, calcium chloride, magnesium chloride, sodium acetate, and the like, and is contained in a container Ta that can communicate with the introduction line L7. Moreover, B agent stock solution consists of the aqueous solution of sodium hydrogencarbonate, and is accommodated in the container Tb which can be connected with the introduction line L8. Then, after the clean water guided from the water supply means 2 and the B agent stock solution introduced from the container Tb by the drive of the introduction pump P2 are stirred and dissolved in the stirring chamber 1b, the solution and the drive of the introduction pump P1 are driven. By stirring and dissolving the agent A stock solution introduced from the container Ta in the stirring chamber 1a, a dialysate having a predetermined concentration is produced.

  The conductivity meter 4 is for measuring the conductivity of the dialysate flowing through the supply-side dialysate flow path L1 so as to detect the concentration of the prepared dialysate, and the dialysate in the supply-side dialysate flow path L1. It is arranged at a position downstream of the production means 1 and upstream of the duplex pump 3. The conductivity measured by the conductivity meter 4 may be numerically displayed or displayed in a graph on a predetermined display or the like in real time.

  The discharge-side dialysate flow path L2 is configured such that one end side thereof is connected to the waste liquid means 5 for treating waste water and the other end side thereof can be connected to the dialysate outlet port 7b of the dialyzer 7, and the supply means 8 is provided in the middle. A bypass line L3 that bypasses the duplex pump 3 is connected. The bypass line L3 is provided with a water removal pump 6 for performing water removal in dialysis treatment. When the water removal pump 6 is driven, the duplex pump 3 is of a fixed type, so that the supply side dialysate The volume of the liquid discharged from the discharge-side dialysate flow path L2 is larger than the amount of dialysate supplied from the flow path L1, and water can be removed (dehydrated) from the blood by the larger volume. ing.

  The supply means 8 supplies the chlorine-based disinfectant cleaning agent accommodated in the container F1 and the inactivating agent accommodated in the container F2 to the discharge-side dialysate flow path L2 via the introduction lines L5 and L6, respectively. Alkali washing, acid washing or neutralization can be performed. The introduction lines L5 and L6 are provided with solenoid valves V3 and V4, respectively. During the dialysis treatment, the solenoid valves V3 and V4 are closed, and the alkali washing process and the acid washing process are performed. Alternatively, in the neutralization step, one of the solenoid valves V3 or V4 is selectively opened.

  The chlorine-based disinfectant cleaner in the container F1 is composed of an alkaline cleaner having a pH of 7 or more (preferably 9 or more), and is particularly preferably a disinfectant containing sodium hypochlorite. For example, hypochlorous acid Other alkali metal hypochlorites such as potassium, chlorinated isocyanuric acid alkali metal salts such as sodium chlorinated isocyanurate or potassium chlorinated isocyanurate may be used. By supplying such an alkaline detergent, it is possible to powerfully remove and disinfect protein stains on the entire dialysate flow path including the supply-side dialysate flow path L1 and the discharge-side dialysate flow path L2. .

  On the other hand, the inactivating agent in the container F2 inactivates the alkaline cleaner (chlorine-based disinfectant cleaner) in the dialysate flow path to make it acidic or neutral. For example, sodium thiosulfate as a reducing agent And an aqueous solution obtained by mixing sodium hydroxide as an alkali agent. That is, by supplying the inactivating agent according to the present embodiment after alkali cleaning, the pH can be lowered to 4 or less, for example, by the reduction action (inactivation) of sodium thiosulfate to obtain an acid cleaning agent. It can be cleaned.

  Thereafter, when the inactivating agent is further supplied, the chlorine in the cleaning agent has already been inactivated. Therefore, even with a small amount of an alkaline component (that is, sodium hydroxide contained in the inactivating agent), the pH can be easily increased. The pH can be neutral from 5 to 9. Here, in the present embodiment, an aqueous solution obtained by mixing sodium thiosulfate (reducing agent) and sodium hydroxide (alkali agent) is accommodated in the container F2, and is acidified during the acid washing step and neutralized in the neutralizing step. However, the reducing agent and the alkali agent may be accommodated in separate containers and selectively supplied.

  In addition, as a reducing agent contained in the inactivating agent, in addition to thiosulfate such as sodium thiosulfate, one or more selected from bisulfite, hyposulfite, and ascorbate can be mentioned. Alkali metal salts are preferred. Examples of the alkali agent contained in the inactivating agent include sodium hydroxide, alkali metal hydroxides such as potassium hydroxide, and one or more selected from alkali metal carbonates such as sodium carbonate and potassium carbonate. .

  However, portions for supplying an alkaline detergent (a detergent containing sodium hypochlorite in this embodiment) to the discharge-side dialysate flow path L2 (introduction line L5 and solenoid valve V3 connected to the container F1). The first supply means of the present invention, an inactivating agent (in this embodiment, an aqueous solution in which sodium thiosulfate as a reducing agent and sodium hydroxide as an alkaline agent are mixed) is supplied to the discharge-side dialysate flow path L2. The part for this (introduction line L6 connected to container F2 and electromagnetic valve V4) corresponds to the 2nd supply means of the present invention.

  According to this embodiment, as described above, an inactivator that uses an alkaline detergent as an acidic acid detergent and an inactivator that can neutralize the acid detergent to serve as a neutralizer are used as one agent. Since the supply means 8 is common, the supply means 8 can be constituted by two of the first supply means and the second supply means, and the existing blood configured to supply two of the disinfecting liquid and the acid cleaning liquid. It can be directly applied to a dialysis system.

  On the other hand, electromagnetic valves V1 and V2 are disposed upstream of the dialysate preparation means 1 in the supply-side dialysate flow path L1 and downstream of the dewatering pump 6 in the discharge-side dialysate flow path L2. The downstream side from the solenoid valve V1 and the upstream side from the solenoid valve V2 are connected by a bypass line L4, and the solenoid valve V5 is disposed in the bypass line L4. At the time of dialysis treatment, the electromagnetic valve V5 is closed (as described above, the electromagnetic valves V3 and V4 are also closed), and the electromagnetic valves V1 and V2 are opened. After the dialysate having a predetermined concentration prepared by the dialysate preparation means 1 is supplied to the dialyzer 7 through the supply-side dialysate flow path L1, it reaches the waste liquid means 5 through the discharge-side dialysate flow path L2. It becomes.

Next, the alkali washing process and the acid washing process after dialysis treatment will be described.
After the compound pump 3 and the water removal pump 6 are stopped and the dialysis treatment is completed, and the blood in the blood circuit (not shown) is collected in the patient's body, the supply-side dialysate flow path L1 and the discharge-side dialysate flow path L2 is removed from the dialysate introduction port 7a and dialysate lead-out port 7b of the dialyzer 7, and as shown in FIG. 2, each tip is connected to the bypass connector C5 and short-circuited.

  At the same time, after the tips of the introduction lines L7 and L8 in the dialysate preparation means 1 are connected from the connection portions C3 and C4 to the connection portions C1 and C2, the dual pump 3 is supplied while supplying clean water from the water supply means 2. Drive. At this time, since the open state of the solenoid valves V1 and V2 and the closed state of the solenoid valves V3, V4 and V5 are maintained, the supplied clean water is supplied to the supply-side dialysate flow path L1 including the dialysate preparation means 1. Then, it is led to the waste liquid means 5 through the discharge side dialysate flow path L2 (including 3 parts of the duplex pump) and the bypass line L3. Thereby, the cleaning process with clean water is completed, and the dual pump 3 is stopped.

  Subsequently, when the solenoid valve V3 is opened while the solenoid valve V3 is opened (the solenoid valve V2 is open and the solenoid valve V4 is closed), and the water removal pump 6 is driven, the next in the container F1. A cleaning agent (alkali cleaning agent) containing sodium chlorite is supplied to the discharge-side dialysate flow path L2 through the introduction line L5. After supplying a predetermined amount of the cleaning agent, the dial valve is closed (the channel is closed) by closing the solenoid valve V3 and closing the solenoid valve V2 and opening the solenoid valve V5. State).

  When the duplex pump 3 is driven again in this closed state, the supplied cleaning agent circulates in the closed channel, and in the circulation process, the alkaline cleaning agent has a pH of about 10, and protein removal, disinfection, etc. An alkali cleaning process for the purpose is performed. Then, after a predetermined time has elapsed, the duplex pump 3 is stopped, the electromagnetic valve V5 is closed again, the V2 is opened again, and the electromagnetic valve V4 is opened while the dewatering pump 6 is driven. The inactivating agent in F2 is supplied to the discharge-side dialysate flow path L2 through the introduction line L6. After supplying a predetermined amount of the inactivating agent, the solenoid valve V4 is closed, the solenoid valve V2 is closed, and the solenoid valve V5 is opened, thereby closing the dialysate channel (the channel is closed). State).

  By driving the dual pump 3 again in this closed state, the supplied inactivating agent circulates in the closed flow path, inactivating the alkaline cleaning agent, and adjusting the pH from about 10 to about 2.8. Lower and attempt to acidify the cleaning agent. By circulating such an acidified cleaning agent (acid cleaning agent) in a closed flow path, an acid cleaning step for the purpose of removing calcium carbonate or the like is performed.

  Further, after a predetermined time has elapsed, the inactivator in the container F2 is again supplied and circulated by the same operation as the inactivator supply, whereby the acid detergent is inactivated and the pH is set to 2 Raise from about 8 to a neutral region of about 5-9 to neutralize the detergent. After the neutralization step, the electromagnetic valve V5 is closed, and clean water is supplied from the water supply means 2 while the electromagnetic valves V1 and V2 are opened, whereby the cleaning step with clean water similar to that described above is performed.

  Here, in the present embodiment, the conductivity measured by the conductivity meter 4 in the above-described series of cleaning steps (cleaning step with clean water-alkali cleaning step-acid cleaning step-neutralization step-cleaning step with clean water). Is measured in real time, and for example, it is configured to monitor whether or not the acid cleaning or neutralization has been performed by reaching a prescribed pH in the acid cleaning or neutralization step.

  That is, in the course of a series of cleaning steps, the conductivity measured by the conductivity meter 4 changes as shown in FIG. The electrical conductivity is in a state where the pH is about 10 (alkali cleaning step), a state where the pH is about 2.8 (acid cleaning step), and a state where the pH is about 8.2 (neutralization step). It can be seen that the measured values rise or fall. Therefore, if the conductivity is measured in real time, it can be determined whether or not the specified pH has been reached.

  More specifically, when shifting from the alkali cleaning process to the acid cleaning process, the difference between the conductivity measured by the conductivity meter 4 and the initial stage of the acid cleaning process (at about pH 10) is 0.5 (mS / cm). ), It can be recognized that the acid region required in the acid cleaning step has been reached, and therefore it can be determined whether or not the acid cleaning in the acid cleaning step is being performed reliably. Similarly, when the acid washing process is shifted to the neutralization process, the difference is approximately 0.9 (mS / cm) when the conductivity measured by the conductivity meter 4 is about 0.9 (mS / cm). Thus, it can be recognized that detoxification has been achieved, so that it is possible to determine whether or not neutralization in the neutralization step is reliably performed.

  According to this embodiment, the conductivity meter (conductivity measuring means) that is essential for the hemodialysis system is also used for disinfection (alkali cleaning) or pH monitoring of waste liquid after acid cleaning. It is possible to monitor whether or not the inactivation of the disinfectant, the acid cleaning agent and the like contained in the waste liquid is satisfactorily performed while suppressing the increase in the temperature and the deterioration of the maintenance workability. In addition, as shown in FIG. 3, the measured value by the conductivity meter 4 may be configured to be displayed in a graph in the course of a series of cleaning steps, or an alarm or the like when the conductivity does not reach a predetermined value. May be configured to sound.

  As mentioned above, although this embodiment was described, this invention is not limited to this, For example, what does not perform a neutralization process in a series of washing processes, or moves to a neutralization process after an alkali washing process The present invention can also be applied. Further, in monitoring the conductivity in a series of washing steps, the correspondence between pH and conductivity may be grasped in advance, and the pH state in the dialysate flow path may be monitored based on the correspondence. . Note that the present invention may be applied to either a hemodialysis system including a personal dialysis apparatus or a hemodialysis system including a dialysis monitoring apparatus.

During the washing or neutralization step by the supply means, the pH state in the dialysate flow path is monitored based on the conductivity measured by the conductivity measuring means, and the conductivity of the dialysate flowing through the dialysate flow path If it is a hemodialysis system that monitors the pH state in the dialysate flow path during the washing or neutralization step by the supply means by using the conductivity measuring means for measuring the dialysis fluid flow path piping configuration It can also be applied to those with different or other functions added.

The schematic diagram which shows the state at the time of the dialysis treatment of the hemodialysis system which concerns on embodiment of this invention. Schematic diagram showing the state of the hemodialysis system during the washing and neutralization steps Graph showing the transition of conductivity in a series of washing steps using the hemodialysis system

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Dialysate preparation means 2 Water supply means 3 Duplex pump 4 Conductivity meter (conductivity measurement means)
5 Waste liquid means 6 Dewatering pump 7 Dialyzer (blood purification means)
8 Supply means L1 Supply side dialysate channel (dialysate channel)
L2 Discharge side dialysate channel (dialysate channel)

Claims (4)

Dialysate preparation means capable of preparing a predetermined concentration of dialysate;
A dialysate flow path that guides the dialysate prepared by the dialysate preparation means to the blood purification means, and guides the dialysate collected from the blood purification means to the waste liquid means;
Conductivity measuring means for measuring the conductivity of the dialysate flowing through the dialysate flow path to detect the concentration of the prepared dialysate;
An alkaline alkaline detergent and an inactivating agent that deactivates the alkaline detergent to become acidic or neutral are supplied to the dialysate flow path that is in a closed state, and an alkaline washing step, an acid washing step, or a neutralization step is performed. Supply means for performing;
A hemodialysis system comprising:
During the washing or neutralization step by the supply means, the pH state in the dialysate flow path is monitored based on the conductivity measured by the conductivity measuring means , and the dialysate flowing in the dialysate flow path A hemodialysis system characterized by monitoring the pH state in the dialysate flow path during the washing or neutralization step by the supply means by diverting the conductivity measuring means for measuring the electrical conductivity .   The supply means supplies a chlorine-based disinfectant cleaning agent to perform an alkali cleaning step, then supplies an inactivator to form an acidic acid cleaning agent, performs an acid cleaning step, and at the time of the acid cleaning step The hemodialysis system according to claim 1, wherein the pH state is monitored by the conductivity measuring means.   The supply means is characterized in that after the acid washing step, an inactivating agent is supplied to perform a neutralization step, and at the time of the neutralization step, the pH state is monitored by the conductivity measuring means. The hemodialysis system according to claim 2. The supply means includes
First supply means for supplying an alkaline cleaner;
A second supply means for supplying an inactivator capable of neutralizing the acid detergent and neutralizing the acid detergent, while the alkaline detergent is an acidic acid detergent;
The hemodialysis system according to any one of claims 1 to 3, characterized by comprising:

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