WO2020004602A1

WO2020004602A1 - Dialysis device, and fluid replacement control method

Info

Publication number: WO2020004602A1
Application number: PCT/JP2019/025756
Authority: WO
Inventors: 尋智長尾; 正岡　勝則
Original assignee: 株式会社ジェイ・エム・エス
Priority date: 2018-06-27
Filing date: 2019-06-27
Publication date: 2020-01-02
Also published as: CN112312941B; CN112312941A; JP2020000415A; JP7183584B2

Abstract

The objective of the present invention is to provide a dialysis device and a fluid replacement control method capable of carrying out appropriate fluid replacement. A dialysis device 100 is provided with a blood circuit 110, a blood purifying means 120, a dialysate circuit 130, a circulating blood quantity measuring means 140, a replenishing liquid injecting means for injecting into the blood circuit replenishing liquid for restoring the circulating blood quantity, and a control unit 150 for controlling the replenishing liquid injecting means in such a way that a predetermined quantity of the replenishing liquid is injected intermittently into the blood circuit at predetermined intervals, wherein the control unit adjusts the next replenishing liquid injection quantity and/or injection interval in such a way that a rate of change in the circulating blood quantity resulting from the next replenishing liquid injection lies in a predetermined range, on the basis of the rate of change in the circulating blood quantity resulting from the most recent injection of replenishing liquid, measured using the measuring means, and controls a rate of water removal by the blood purifying means in such a way that water content corresponding to the entire quantity of replenishing liquid injected into the blood circuit is recovered during the period from the start to the end of the dialysis.

Description

Dialysis apparatus and replacement fluid control method

The present invention relates to a dialysis device and a replacement fluid control method using the dialysis device.

In dialysis treatment, blood is removed from the patient's arterial side using a pump and sent to blood purification means such as a dialyzer or hemodiafilter, and blood from which waste and excess water have been removed is transferred to the patient's arterial side. A return is made.
Generally, in dialysis treatment, blood purification is performed over a period of about four hours in one treatment, and blood is purified and excess water in the body is removed as the dialysis time elapses. Because of this blood purification, the amount of circulating blood flowing through the body of the patient decreases, and it is not uncommon for patients to exhibit a symptom of lowering blood pressure in the latter half of dialysis treatment.

(4) When the circulating blood volume decreases, in a normal biological reaction, peripheral blood vessels are contracted by the action of autonomic nerves, thereby maintaining the central circulating blood volume. In addition, when blood is concentrated by removing water, plasma refilling in which plasma components move from the interstitium into the blood vessel occurs due to the difference in osmotic pressure, and the circulating blood volume is maintained. However, such a biological reaction may not be performed normally depending on the patient, and it may be difficult to continue the dialysis treatment due to a decrease in blood pressure.

When such a decrease in blood pressure occurs, measures such as performing replacement fluid using physiological saline or purified dialysate in the blood are taken in order to rapidly increase the amount of circulating blood. .
In recent years, in order to prevent the occurrence of a decrease in blood pressure due to a decrease in circulating blood volume accompanying water removal, in the treatment of hemodialysis (so-called HD) or hemofiltration dialysis (so-called HDF), for example, 150 mL to 200 mL every 30 minutes is used. An “intermittent replenishment type hemodiafiltration method” has been proposed in which rehydration is repeatedly performed, and water equivalent to the replenisher is added to the original water removal amount to remove water (see Non-Patent Documents 1 and 2).

As described above, the occurrence of a decrease in blood pressure can be suppressed by systematically replenishing fluid during dialysis treatment.However, since conditions such as basal weight and water removal amount vary depending on the patient, an appropriate replenisher for stabilizing blood pressure is used. It is considered that the injection amount and the injection interval are different. In addition, even in the same patient, the circulatory dynamics of blood (circulating blood volume, plasma refilling rate, etc.) change during the course of dialysis treatment. Therefore, when rehydration is performed under uniform conditions that do not depend on the condition of the patient, the replenishment may be excessive and cause a rapid increase in blood pressure, or the effect of suppressing the rapid decrease in blood pressure due to insufficient rehydration may be sufficient. May not be obtained.

Accordingly, an object of the present invention is to provide a dialysis apparatus and a replacement fluid control method capable of performing appropriate replacement fluid.

The present invention relates to a blood circuit, a blood purification means arranged in the blood circuit, capable of removing water in blood, and a dialysate connected to the blood purification means for introducing and discharging a dialysate into the blood purification means. A circuit, a measuring means for measuring a change rate of a circulating blood volume, a replenishing solution injecting means for injecting a replenishing solution for restoring a circulating blood volume reduced by water removal into the blood circuit, and a predetermined A control unit that controls the replenisher injecting means so as to inject a predetermined amount of replenisher intermittently at intervals, wherein the control unit is configured to control the latest replenishment measured by the measurement unit. Based on the change rate of the circulating blood volume due to the infusion of the replenisher, the next infusion amount and / or infusion interval of the replenisher solution such that the change rate of the circulating blood volume due to the next infusion of the replenisher is within a predetermined range. From the start to the end of dialysis. During relates dialysis apparatus for controlling the water removal speed of the blood purification unit to recover the water that corresponds to the total amount of the replenisher to be injected into at least the blood circuit.

Preferably, the blood purifying means and the dialysate circuit are used as the replenisher injecting means, and a dialysate which is back-filtered by the blood purifying means is used as the replenisher.

The present invention also provides a blood circuit, a blood purification unit disposed in the blood circuit, capable of removing water in blood, the blood purification unit is connected, and a dialysate circuit for introducing and leading a dialysate, Measuring means for measuring the rate of change of the circulating blood volume, replenishing solution injecting means for injecting a replenishing solution for restoring the circulating blood volume reduced by water removal into the blood circuit, and intermittently at predetermined intervals in the blood circuit A control unit for controlling the replenisher injecting means so as to inject a predetermined amount of replenisher, and a replenisher control method using a dialysis device comprising: The rate of change in circulating blood volume due to the most recent replenisher injection is calculated, and based on the rate of change, the rate of change in circulating blood volume due to the next infusion of replenisher falls within a predetermined range. The amount and / or interval of replenishment And integer, a time period from the start to the end dialysis relates replacement fluid control method for controlling the water removal speed of the blood purification unit to recover the water that corresponds to the total amount of the replenisher to be injected into at least the blood circuit.

Further, if the change rate of the circulating blood volume due to the most recent infusion of the replenisher is within the predetermined range, the next infusion amount of the replenisher is set to the same amount as the most recent infusion amount, and the change rate is in the predetermined range. If the change rate is smaller than the latest range, the next injection amount of the replenisher is set to an amount smaller than the latest injection amount according to the change rate. It is preferable that the injection amount of the replenisher be larger than the latest injection amount.

Further, if the change rate of the circulating blood volume due to the most recent infusion of the replenisher is within the predetermined range, an interval until the next infusion of the replenisher is a predetermined infusion interval, and the change rate is in the predetermined range. If it is larger, the interval until the next replenisher is injected is made longer than the predetermined injection interval according to the change rate, and if the change rate is smaller than the predetermined value, the next time according to the change rate, The interval between injections of the replenisher is shorter than the predetermined injection interval, and is equivalent to the amount of the replenisher injected last between the injection of the latest replenisher and the injection of the next replenisher. It is preferable to control the water removal rate of the blood purification means so as to collect the removed water as a replacement fluid.

Preferably, the predetermined range is 5% to 10%.

According to the present invention, an appropriate replacement fluid can be performed according to the circulatory movement of blood during dialysis treatment, so that a rapid change in blood pressure can be reduced.

It is a figure showing the schematic structure of a dialysis device. It is a figure showing a dialysis process performed with a dialysis device. It is a figure which shows the fluid replacement process performed with a dialysis device. It is a figure which shows the rate of change of the circulating blood volume when replacing fluid during dialysis. It is a flowchart for demonstrating the replacement fluid control method of this invention. It is a flowchart for demonstrating the setting method of the replacement fluid condition in 1st Embodiment. FIG. 4 is a diagram for explaining a method of injecting and collecting a replenisher in the first embodiment. FIG. 6 is a diagram for explaining another method of injecting and collecting a replenisher in the first embodiment. It is a flowchart for demonstrating the setting method of the replacement fluid condition in 2nd Embodiment. It is a figure for explaining an injection and recovery method of a replenisher in a 2nd embodiment.

Hereinafter, preferred embodiments of the dialysis device and the replacement fluid control method of the present invention will be described with reference to the drawings.
The fluid replacement control method of the present invention can be applied to a case where fluid replacement is performed intermittently during dialysis treatment such as hemodialysis (so-called HD) or hemofiltration dialysis (so-called HDF). As an application example of the present invention, a case will be described in which intermittent replenishment-type hemofiltration dialysis is performed in which replenishment is performed intermittently using a back-filtered dialysate.

<First embodiment>
FIG. 1 is a diagram showing a schematic configuration of a dialysis device 100 according to the first embodiment of the present invention.

As shown in FIG. 1, the dialysis apparatus 100 includes a blood circuit 110 for flowing blood, a blood purification unit 120, a dialysate circuit 130, a circulating blood volume measurement unit 140 arranged in the blood circuit 110, A unit 150.

The blood circuit 110 has an arterial line 111, a venous line 112, a drug line 113, and a priming fluid discharge line 114. The arterial line 111, the venous line 112, the drug line 113, and the priming liquid discharge line 114 are each mainly composed of a flexible soft tube through which a liquid can flow.

One end of the arterial line 111 is connected to a blood inlet 122a of a blood purification unit 120 described later. In the arterial line 111, an arterial connection section 111a, an arterial bubble detector 111b, a blood pump 111c, and a circulating blood volume measuring means 140 described later are arranged.
The arterial connection 111a is arranged on the other end of the arterial line 111. A needle inserted into a blood vessel of a patient is connected to the artery-side connection portion 111a.
The arterial-side bubble detector 111b detects the presence or absence of bubbles in the tube.
The blood pump 111c is arranged downstream of the arterial-side air bubble detector 111b in the arterial-side line 111. The blood pump 111c delivers a liquid such as blood or priming liquid inside the arterial line 111 by squeezing a tube constituting the arterial line 111 with a roller.

One end of the venous line 112 is connected to a blood outlet 122b of the blood purification means 120 described later. The venous line 112 includes a venous connection 112a, a venous bubble detector 112b, a drip chamber 112c, and a venous clamp 112d.
The vein-side connection part 112a is arranged on the other end side of the vein-side line. A needle inserted into a blood vessel of a patient is connected to the vein-side connecting portion 112a.
The vein side bubble detector 112b detects the presence or absence of bubbles in the tube.
The drip chamber 112c is disposed upstream of the vein-side bubble detector 112b. The drip chamber 112c stores a certain amount of blood in order to remove bubbles, coagulated thrombus / clot, and the like mixed in the venous line 112, and to measure venous pressure.
The vein-side clamp 112d is disposed downstream of the vein-side bubble detector 112b. The vein-side clamp 112d is controlled in accordance with the detection result of bubbles by the vein-side bubble detector 112b, and opens and closes the flow path of the vein-side line 112.

The drug line 113 supplies a drug required during hemodialysis to the arterial line 111. One end of the drug line 113 is connected to the drug solution pump 113a for sending out a drug, and the other end is connected to the arterial line 111. The medicine line 113 is provided with a clamp means (not shown), and the flow path is closed by the clamp means except when the medicine is injected. In the present embodiment, the other end of the drug line 113 is connected to the arterial line 122 on the upstream side of the circulating blood volume measuring means 140.

The priming liquid discharge line 114 is connected to the drip chamber 112c. The priming liquid discharge line 114 is provided with a priming liquid discharge line clamp 114a. The priming liquid discharge line 114 is a line for discharging the priming liquid in a priming step described later.

The blood purification means 120 includes a cylindrical container body 121 and a dialysis membrane (not shown) housed inside the container body 121. It is divided into a side channel and a dialysate side channel (neither is shown). In the container body 121, a blood inlet 122a and a blood outlet 122b communicating with the blood circuit 110, and a dialysate inlet 123a and a dialysate outlet 123b communicating with the dialysate circuit 130 are formed.

According to the blood circuit 110 and the blood purification means 120 described above, the blood extracted from the artery of the subject (dialysis patient) flows through the arterial line 111 by the blood pump 111c, and the blood-side flow path of the blood purification means 120 Will be introduced. The blood introduced into the blood purification means 120 is purified by a dialysate flowing through a dialysate circuit 130 described later via a dialysis membrane. The blood purified by the blood purification means 120 flows through the venous line 112 and is returned to the subject's vein.

In the present embodiment, the dialysate circuit 130 is constituted by a so-called closed volume control type dialysate circuit 130. The dialysate circuit 130 includes a dialysate supply line 131a, a dialysate drain line 131b, a dialysate introduction line 132a, a dialysate derivation line 132b, and a dialysate delivery unit 133.

The dialysate sending section 133 includes a dialysate chamber 1331, a bypass line 1332, and a water removal / back-filtration pump 1333.
The dialysate chamber 1331 is formed of a hard container capable of storing a fixed volume (for example, 300 ml to 500 ml) of dialysate, and the inside of this container is formed by a soft diaphragm (diaphragm) and a liquid sending container 1331 a and a drain. It is partitioned into a housing 1331b.
The bypass line 1332 connects the dialysate outlet line 132b and the dialysate drain line 131b.

水 Water removal / back-filtration pump 1333 is arranged in bypass line 1332. The water removal / back-filtration pump 1333 is a direction in which the dialysate in the bypass line 1332 flows toward the dialysate drain line 131b (water removal direction) and a direction in which the dialysate flows through the dialysate discharge line 132b (back filtration direction). It is constituted by a pump driven so as to be able to send liquid.

The dialysate supply line 131a has a proximal end connected to a dialysate supply device (not shown) and a distal end connected to the dialysate chamber 1331. The dialysis fluid supply line 131a supplies the dialysis fluid to the fluid supply storage unit 1331a of the dialysis fluid chamber 1331.

The dialysate introduction line 132a connects the dialysate chamber 1331 and the dialysate inlet 123a of the blood purification means 120, and dialyses the dialysate stored in the liquid supply storage part 1331a of the dialysate chamber 1331 by the dialysis of the blood purification means 120. Introduce into the liquid side flow path.

The dialysate outlet line 132b connects the dialysate outlet 123b of the blood purification unit 120 and the dialysate chamber 1331 and leads the dialysate discharged from the blood purification unit 120 to the drainage storage unit 1331b of the dialysate chamber 1331. I do.

The dialysate drain line 131b has a proximal end connected to the dialysate chamber 1331 and discharges the dialysate drain contained in the drain reservoir 1331b.

According to the dialysate circuit 130 described above, the inside of the hard container constituting the dialysate chamber 1331 is partitioned by the soft diaphragm (diaphragm), so that the amount of dialysate drawn out from the dialysate chamber 1331 (liquid sending accommodation) The amount of dialysate supplied to the portion 1331a) and the amount of drainage collected in the dialysate chamber 1331 (drainage storage portion 1331b) can be made equal.
Accordingly, in a state where the water removal / back-filtration pump 1333 is stopped, the flow rate of the dialysate introduced into the blood purification means 120 and the amount of the dialysate (effluent) derived from the blood purification means 120 are equalized. Can be.

When the water removal / back-filtration pump 1333 is driven so as to feed in the back-filtration direction, a part of the drainage discharged from the dialysate chamber 1331 passes through the bypass line 1332 and the dialysate outlet line 132b. And is collected again in the dialysate chamber 1331. Therefore, the amount of dialysate discharged from the blood purification means 120 is changed from the amount recovered in the dialysate chamber 1331 (that is, the amount of dialysate flowing through the dialysate introduction line 132a) to the amount of dialysate flowing through the bypass line 1332. It becomes the amount which reduced the amount of liquid. As a result, the amount of dialysate discharged from the blood purification means 120 flows through the dialysate introduction line 132a by the amount of the dialysate (drained liquid) collected again in the dialysate chamber 1331 through the bypass line 1332. The flow rate of the dialysate to be used is smaller. That is, when the water removal / back-filtration pump 1333 is driven to feed in the back-filtration direction, a predetermined amount of dialysate is injected (back-filtered) into the blood circuit 110 in the blood purification means 120 (FIG. 3).

As described above, in this embodiment, the blood purification means 120 and the dialysate circuit 130 (water removal / back-filtration pump 1333) are used as replenisher injection means, and the back-filtered dialysate is used as the replenisher. In other words, the dialysate as a replenisher is injected from the dialysate circuit 130 into the blood circuit 110 via the blood purification means 120 by driving the dewatering / reverse filtration pump 1333 in the reverse filtration direction. It should be noted that a replenisher line may be connected to the blood circuit 110 to serve as a replenisher injecting means, and a physiological saline solution or the like may be used as the replenisher. Alternatively, a replenisher line provided with a replenisher pump may be connected from the dialysate introduction line 132a to the arterial line 111 or the venous line 112 to serve as a replenisher injecting means, and the dialysate may be used as a replenisher.

On the other hand, when the water removal / back-filtration pump 1333 is driven so as to feed the water in the water removal direction, the amount of the dialysate flowing through the dialysate outlet line 132 b is equal to the amount of the dialysate collected in the dialysate chamber 1331. (Ie, the amount of dialysate flowing through the dialysate introduction line 132a) and the amount of dialysate flowing through the bypass line 1332. As a result, the amount of dialysate flowing through the dialysate outlet line 132b is equal to the amount of dialysate (drained liquid) discharged to the dialysate drain line 131b through the bypass line 1332, and the dialysate inlet line 132a is thus reduced. It is larger than the volume of dialysate flowing. That is, when the water removal / back-filtration pump 1333 is driven to feed in the water removal direction, a predetermined amount of water is removed from the blood in the blood purification means 120 (see FIG. 2).

The circulating blood volume measuring means 140 is a sensor for measuring a hematocrit value of blood flowing in the blood circuit 110. For example, a hematocrit value can be measured based on the light transmittance of blood obtained by irradiating blood with near infrared rays. Based on the hematocrit value measured over time by the circulating blood volume measuring means 140, the rate of change of the circulating blood volume in the patient's body can be calculated. As shown in FIG. 1, the circulating blood volume measurement unit 140 is located downstream of the blood pump 111 c in the arterial line 111 and is located on the blood purification unit 120 so that the blood purification unit 120 is not easily affected by water removal or replacement fluid. It is located upstream.

The control unit 150 is configured by an information processing device (computer), and controls the operation of the dialysis device 100 by executing a control program. Further, the control unit 150 calculates a change rate of the circulating blood volume based on the hematocrit value measured by the circulating blood volume measuring means 140.
Specifically, the control unit 150 controls operations of various pumps and clamps arranged in the blood circuit 110 and the dialysate circuit 130, and controls various processes performed by the dialysis device 100, for example, a priming process, A blood step, a dialysis step, a replacement fluid step, a blood return step, and the like are performed.

Various steps will be briefly described with reference to FIGS.
In the priming step, the blood circuit 110 and the blood purification means 120 are washed and cleaned using a back-filtration dialysate as a priming solution.
In the blood removal step, the blood of the patient is suctioned to fill the arterial line 111 and the venous line 112 with blood. After the blood removal step, a dialysis step for purifying the blood and removing water is performed (see FIG. 2). In the dialysis step, excess water of the patient is removed, and the replacement fluid is also removed.
The fluid replacement step is performed intermittently during the dialysis step (see FIG. 3). After the dialysis step, a blood return step of returning blood to the patient is performed.

透析 Among the various processes performed by the dialysis device 100, the dialysis process and the replacement fluid process related to the change in the circulating blood volume will be described in detail below.

The dialysis step will be described with reference to FIG.
In the dialysis step, the blood of the patient introduced from the arterial connection 111a is purified by the blood purification means 120 through the arterial line 111, and returned to the patient from the venous connection 112a through the venous line 112. .

In the dialysis step, as shown in FIG. 2, the arterial-side connecting portion 111a and the venous-side connecting portion 112a are each connected to a needle punctured in a patient's blood vessel, and the priming fluid discharge line clamp 114a is closed. In the state, the vein side clamp 112d is open.

The dialysate supply device (not shown) supplies and discharges the dialysate to and from the dialysate chamber 1331 at an average flow rate of 500 ml / min, and sends the water removal / reverse filtration pump 1333 in the water removal direction. To operate. By setting the feed rate of the water removal / back-filtration pump 1333 to 10 ml / min as an example, the blood purification means 120 performs water removal at 10 ml / min.
The blood pump 111c gradually increases the flow rate from 40 to 50 ml / min at the start of the dialysis step to, for example, about 200 ml / min, and sends the blood from the arterial side connection part 111a to the blood purification means 120 side.
Blood flows into blood purification means 120 from blood inlet 122a at a flow rate of 200 ml / min, is removed at a flow rate of 10 ml / min, and is drawn out from blood outlet port 122b at a flow rate of 190 ml / min. Further, the dialysate drainage is drawn out from the dialysate outlet 123b.
In this way, water is gradually removed from the blood in the dialysis step, and the amount of circulating blood gradually decreases accordingly.

Next, the fluid replacement step will be described with reference to FIG.
The fluid replacement step is a step of injecting the back-filtration dialysate into the blood circuit 110. In the present embodiment, in order to prevent a decrease in blood pressure due to a decrease in circulating blood volume due to water removal, the fluid replacement step is intermittent at predetermined intervals. Done in

In the rehydration step, as shown in FIG. 3, the artery-side connection part 111a and the vein-side connection part 112a are each connected to a needle punctured in a blood vessel of the patient, as in the dialysis step, and are provided with a priming liquid discharge line. The clamp 114a is closed, and the venous clamp 112d is open.

The dialysate supply device (not shown) supplies and discharges the dialysate to and from the dialysate chamber 1331 at an average flow rate of 500 ml / min, and sends the water removal / back-filtration pump 1333 in the reverse filtration direction. To operate. For example, when a 200 ml replacement fluid is to be supplied, the supply rate of the water removal / back-filtration pump 1333 is set to 150 ml / min as an example, so that the blood purification means 120 performs a 150 ml / min replacement fluid in about 80 seconds. Is
The blood pump 111c gradually reduces the flow rate from 200 ml / min to about 50 ml / min during the dialysis step, and sends out the blood from the artery-side connection portion 111a to the blood purification means 120.
Blood flows into the blood purification means 120 at a flow rate of 50 ml / min from the blood inlet 122 a, the back-filtration dialysate is supplemented at a flow rate of 150 ml / min, and 200 ml of blood diluted from the blood outlet 122 b is supplied. / Min. Thus, the dialysate is rapidly replenished into the blood in about 80 seconds in the rehydration step.

Next, a specific rehydration control method in the present embodiment will be described with reference to FIGS.

First, the effect of intermittent replacement fluid will be briefly described.
During dialysis treatment, water (plasma) in the blood is removed as the water removal proceeds, and the circulating blood volume decreases. When the circulating blood volume decreases and the protein concentration in the blood rises, water (plasma) gradually moves from the stroma to the blood vessel due to the difference in osmotic pressure between the blood vessel and the blood vessel (the stroma) ( Plasma refill), blood volume is restored and blood pressure is maintained. However, when the rate of plasma refill does not catch up with the rate of water removal, the amount of circulating blood decreases and blood pressure decreases, and the autonomic nervous system contracts peripheral blood vessels to maintain blood pressure. Happens. If this does not work properly, the rate of plasma refilling will be much lower than the rate of water removal, the rate of decrease in circulating blood volume will increase, and a rapid drop in blood pressure will occur.

In order to prevent such a rapid decrease in blood pressure, fluid replacement is performed intermittently. By performing dialysis while recovering blood circulation by performing fluid replacement, blood pressure is prevented from lowering, peripheral circulation is improved, and the speed of plasma refilling is maintained. As a result, the rate of decrease in the amount of circulating blood after dialysis can be reduced even at the same water removal rate (excluding the replacement fluid collection) as compared to the case where no replacement fluid is performed. The increase in the amount of circulating blood due to the replacement fluid is removed by the blood purification means 120 from the start to the end of the dialysis. Therefore, the total water removal amount is the sum of the patient's excess water (weight removal water) and the replacement fluid collection.
The present invention makes it possible to carry out rehydration at an appropriate injection amount and injection interval in order to sufficiently obtain the above-mentioned effects by performing rehydration.

Next, a description will be given of a change in the amount of circulating blood when fluid replacement is performed under general conditions.
FIG. 4 is a diagram showing the rate of change in the amount of circulating blood when a replacement fluid is performed under the conditions of a commonly performed injection volume of 200 ml and an injection interval of 30 minutes. As shown in FIG. 4, it can be seen that the amount of circulating blood is increased by performing the replacement fluid every 30 minutes.
It is considered that the rate of increase in the amount of circulating blood due to the replacement fluid depends on the replacement fluid from outside the body and the amount of plasma that moves into the blood vessel due to refilling of the plasma in the body. Since the rate of plasma refilling varies from patient to patient and also during dialysis, the proper replenishment rate will vary from one rehydration to another. In addition, in the case of this embodiment, since the water removal by the blood purification means 120 is not performed during the infusion of the replenisher, it is not necessary to consider the decrease due to the water removal.

結果 As a result of the present inventors' investigation on the appropriate amount of replacement fluid, it is considered that it is desirable that the rate of change (increase rate) of the circulating blood volume after one replacement fluid is within the range of 5 to 10%. If the rate of change exceeds 10%, the circulating blood volume rises rapidly, which may lead to a rapid rise in blood pressure. In addition, in the case of a patient having a heart disease, the burden due to an increase in blood pressure increases, so the upper limit of the rate of change is set to a value lower than 10%, and the amount of infusion per replenisher is reduced. Adjustment may be made to increase the number of injections. In addition, if the infusion amount of the replacement fluid is excessive, the water removal amount for the replacement fluid recovery increases, and the total water removal amount increases together with the excess water of the patient. As a result, the water removal rate increases, and the risk of lowering blood pressure increases. On the other hand, if the rate of change is less than 5%, the above-described effect of the replacement fluid cannot be sufficiently obtained.

Therefore, a method of controlling the amount of the replenisher to be injected so that the rate of change of the circulating blood volume by the replenisher is in the range of 5 to 10% will be described.

(First replenisher control method)
In the present embodiment, as an example, a case will be described with reference to FIG. 5 and FIG. 6 in which the infusion interval of the replenisher is fixed at 30 minutes and the replenisher is performed a total of seven times during the treatment for 4 hours.

The control unit 150 measures the hematocrit value by the circulating blood volume measuring means 140, and calculates the change rate of the circulating blood volume over time based on the measured hematocrit value.
For example, the first replenishment solution can be determined according to the patient's basal weight. For example, the infusion amount of the replenisher can be determined by setting the amount of replenisher to 200 ml for a patient weighing 50 kg or more and 150 ml for a patient less than 50 kg at a time.

The flow of the dialysis treatment will be described with reference to FIG.
After the start of dialysis, the dialysis device 100 performs water removal at a predetermined speed (S100). After a predetermined time has elapsed (S110), replacement fluid is performed at a predetermined injection amount (S120).
It is determined whether or not the latest replacement fluid is the last replacement fluid (S130). If it is not the last replacement fluid, the next replacement fluid condition is set based on the latest change rate (increase rate) of the circulating blood volume (S140). If it is the last replacement fluid, water is removed at a predetermined water removal rate (S150), and after a predetermined dialysis time has elapsed (S160), the dialysis treatment is terminated. Here, the predetermined water removal rate in S150 indicates a water removal rate at the start of dialysis treatment set based on the amount of water (water removal amount) to be removed from the patient by dialysis treatment. Similarly, the predetermined dialysis time in S160 indicates the water removal time at the start of the dialysis treatment.

With reference to FIG. 6, a method for setting the replacement fluid conditions will be described.
The rate of change in circulating blood volume before the start of infusion of the replenisher and after the end of infusion due to the most recent rehydration is calculated (S141), and it is determined whether the rate of change by the rehydration is within a predetermined range (S142). . If the rate of change due to the replacement fluid is within the range of 5 to 10%, it is determined that the injection amount of the replenisher is an appropriate amount, and the replacement fluid 30 minutes after the next time is used as the same injection amount as the first injection. (S143). When the rate of change due to the replacement fluid exceeds 10%, it is determined that the injection amount is excessive, and the injection amount of the replacement fluid 30 minutes after the next time is reduced (S144). Specifically, the larger the rate of change of the circulating blood volume, the smaller the amount of replacement fluid to be infused, and the lower the rate of change of the circulating blood volume, the lower the rate of infusion of the replacement fluid at a fixed rate. For example, the ratio of the change rate of the circulating blood volume to the actual change rate with respect to the upper limit of 10% is calculated, and the replacement fluid amount to be reduced by multiplying the initial replacement fluid amount by 200 ml is calculated. In the above example, when the change rate of the circulating blood volume due to replacement fluid exceeds a predetermined range, control is performed so as to change both the injection amount and the injection interval of replacement fluid, but one is not changed and only the other is changed. Control may be performed.
If the change rate due to the replacement fluid is less than 5%, it is determined that the injection amount is too small, and the injection amount of the replacement fluid 30 minutes after the next time is increased (S145). Specifically, the smaller the rate of change in circulating blood volume, the greater the amount of replacement fluid to be infused, or the greater the rate of infusion of replacement fluid at a constant rate regardless of the rate of change in circulating blood volume. For example, the ratio of the change rate of the circulating blood volume to the actual change rate with respect to the upper limit of 10% is calculated, and the initial replacement fluid amount is multiplied by the calculated ratio to 200 ml to calculate the replacement fluid amount to be increased.
In this way, the control unit 150 sets the change rate of the circulating blood volume by the next replacement fluid on the basis of the change rate of the circulating blood volume by the latest replacement fluid in the range of 5 to 10%. Adjust the injection volume.

The increased amount of the replenisher in the circulating blood volume may be collected by adjusting the water removal rate from the start to the end of the dialysis, and in the present embodiment, the amount injected with the latest replenisher as shown in FIG. By the next rehydration, it was to be collected in addition to the patient's excess water (dehydrated water).
In addition, as shown in FIG. 8, regarding the method of recovering the increased replenishment solution, as shown in FIG. Good. In this case, regardless of the rate of change of the circulating blood volume due to the latest replacement fluid, the last replacement fluid injection amount may be set to a predetermined amount, and water removal may be performed ahead of time. In addition, for the sake of simplicity, the case where the infusion amount of the replacement fluid is constant is shown, but in actuality, the injection amount of the replacement fluid other than the final replacement fluid injection amount depends on the rate of change of the circulating blood volume due to the latest replacement fluid. Fluctuate based on

According to the dialysis device 100 and the first replacement fluid control method of the first embodiment described above, the following effects are obtained.

(1) The dialysis apparatus 100 includes a blood circuit 110, a blood purification means 120, a dialysate circuit 130, a circulating blood volume measuring means 140, a replenisher injecting means for injecting a replenisher into the blood circuit 110, A control unit 150 for controlling the replenisher injecting means so as to intermittently inject a predetermined amount of replenisher into the blood circuit 110 at predetermined intervals. Based on the rate of change of the circulating blood volume due to the most recent replenishment infusion measured by 140, the rate of change of the circulating blood volume due to the next infusion of the replenishment is within a predetermined range. The injection amount and the injection interval are adjusted, and during the period from the start to the end of the dialysis, the water removal rate of the blood purification means 120 is controlled so as to collect at least the water equivalent to the total amount of the replenisher to be injected into the blood circuit 110. Suppose .
This makes it possible to realize an appropriate replacement fluid that matches the circulatory dynamics of the patient's blood, so that a rapid increase in blood pressure due to replacement fluid can be suppressed, and a decrease in blood pressure due to removal of water can be suppressed. Therefore, the change in blood pressure during dialysis can be reduced, and dialysis treatment with a reduced burden on the patient can be performed. In addition, by adjusting the injection amount of the replacement fluid so as not to be excessive, it is possible to reduce the water removal rate for the replacement fluid collection and to suppress the decrease in blood pressure caused by the water removal rate being too high.

(2) In the replacement fluid control method using the dialysis device 100, the change rate of the circulating blood volume due to the injection of the latest replenisher is calculated using the change rate measured by the circulating blood volume measuring means 140, and the latest replenisher solution is calculated. If the change rate of the circulating blood volume due to the injection is within a predetermined range, the next injection amount of the replenisher is the same as the latest injection amount, and if the change rate is larger than the predetermined range, the change rate The next injection amount of the replenisher is set to a smaller amount than the latest injection amount according to the above, and if the change rate is smaller than the predetermined range, the next injection amount of the replenisher is changed according to the change rate. The amount was set to be larger than the injection amount.
In this way, if the latest replenishment volume was appropriate, replenishment was performed in the same manner the next time, and if the last replenishment volume was too large, the next replenishment volume was reduced and the most recent replenishment volume was small. If it is too long, it is possible to increase the amount of fluid replacement at the next time and realize a fluid replacement appropriate for the blood circulation of the patient.

<Second embodiment>
Next, a second replacement fluid control method using the dialysis device 100 described in the first embodiment will be described with reference to FIGS. 9 and 10. The present embodiment differs from the first replacement fluid control method in that the replacement interval of the replacement fluid is not constant.

(Second rehydration control method)
In the present embodiment, as an example, the infusion interval of the reference replenisher is set to 30 minutes, and the second and subsequent infusion intervals are adjusted based on the rate of change in circulating blood volume due to the most recent replenishment.

Since the flow of the dialysis treatment is the same as that described in the first embodiment, a description thereof will be omitted, and a method of setting the replacement fluid condition will be described with reference to FIG.
As shown in FIG. 9, the rate of change of the circulating blood volume before the start of infusion of the replenisher and after the end of infusion by the most recent rehydration is calculated (S141), and whether or not the rate of change by the rehydration is within a predetermined range. Is determined (S142). If the rate of change due to the replacement fluid is in the range of 5 to 10%, it is determined that the injection amount of the replenisher is an appropriate amount, and the next replacement fluid is set to the same injection amount as the first time, and the time until the next replacement fluid is changed. The injection interval is set as a reference injection interval (30 minutes). (S146). If the rate of change due to rehydration exceeds 10%, it is determined that the injection amount is excessive, and the injection amount of the next replacement fluid is reduced and the injection interval based on the injection interval until the next replacement fluid is set as a reference. The interval is longer than the interval (30 minutes) (S147). Specifically, the greater the rate of change in circulating blood volume, the longer the infusion interval may be, or the longer the infusion interval may be a constant rate regardless of the rate of change in circulating blood volume. For example, the ratio of the change rate of the circulating blood volume to the upper limit of 10% and the actual change rate is calculated, and the reference injection interval 30 minutes is multiplied by the calculated ratio to calculate the increase time of the injection interval.
When the rate of change due to rehydration is less than 5%, it is determined that the injection amount is too small, and the injection amount of the next replacement fluid is increased and the injection interval until the next replacement fluid is set as a reference. The injection is performed at a time shorter than the injection interval (30 minutes) (S148). Specifically, the smaller the rate of change in circulating blood volume, the shorter the injection interval may be, or the shorter the rate of infusion interval may be, regardless of the rate of change in circulating blood volume. For example, the ratio of the change rate of the circulating blood volume to the upper limit of 10% of the actual change rate is calculated, and the reference injection interval of 30 minutes is multiplied by the calculated ratio to calculate the decrease time of the injection interval.

In this manner, the control unit 150 injects the next replenisher so that the change rate of the circulating blood volume by the next replacement fluid is in the range of 5 to 10% based on the change rate of the circulating blood volume by the latest replacement fluid. Adjust the volume and adjust the interval between injections until the next fluid replacement.
Further, as shown in FIG. 10, the injection amount of the final replacement fluid may be appropriately increased or decreased according to the remaining time of the dialysis after the last replacement fluid.

The increased amount of the replenisher in the circulating blood volume may be collected by adjusting the water removal rate between the start and the end of the dialysis. In the present embodiment, as in the case described in the first embodiment, the latest replenisher is used. The amount injected in (1) was collected by the next replacement fluid (see FIG. 10).

According to the second replacement fluid control method of the second embodiment described above, the following effects are obtained in addition to the effects (1) and (2).

(3) The replacement fluid control method using the dialysis device 100 may be configured such that, if the rate of change of the circulating blood volume due to the most recent replenisher injection is within the above-mentioned predetermined range, the interval until the next replenisher is injected is set to a predetermined value. If the change rate is larger than a predetermined range, the interval between injections of the next replenisher is set longer according to the change rate than the predetermined injection interval, and the change rate is smaller than the predetermined range. For example, the interval between the injections of the next replenisher is set shorter than the predetermined injection interval in accordance with the change rate, and the interval between the injection of the most recent replenisher and the injection of the next replenisher is made. The water removal rate of the blood purification means 120 is controlled so as to collect water corresponding to the amount of the replenisher added.
In this way, when the injection amount by the latest replacement fluid is excessive, by increasing the injection interval until the next replacement fluid, the removal rate of the replacement fluid can be reduced, and the removal rate is too high. Can reduce the occurrence of blood pressure drop due to, and, if the latest infusion volume is too small, shorten the interval between infusions until the next rehydration to speed up the sufficient recovery of circulating blood volume In addition, the occurrence of a decrease in blood pressure can be suppressed.

As described above, the preferred embodiments of the dialysis device and the replacement fluid control method of the present invention have been described. However, the present invention is not limited to the above-described embodiments, and can be appropriately changed.
For example, in the above-described embodiment, a case has been described in which a back-filtered dialysate is used as a replenisher. However, physiological saline may be used as a replenisher, or directly into a blood circuit without passing through a blood purification unit. It may be configured to replenish the dialysate from the connected dialysate line.

Reference Signs List 100 dialyzer 110 blood circuit 111 arterial line 111c blood pump 112 venous line 120 blood purification means 130 dialysate circuit 140 circulating blood volume measuring means 150 control unit

Claims

Blood circuit,
A blood purification means arranged in the blood circuit and capable of removing water in blood,
A dialysate circuit connected to the blood purification means, for introducing and leading a dialysate to the blood purification means,
Measuring means for measuring the rate of change in circulating blood volume,
Replenisher injection means for injecting a replenisher for recovering the circulating blood volume reduced by water removal into the blood circuit,
A control unit that controls the replenisher injection means so as to inject a predetermined amount of replenisher intermittently at predetermined intervals in the blood circuit, and a dialysis device comprising:
The control unit is configured such that the rate of change in the amount of circulating blood due to the next injection of the replenisher falls within a predetermined range based on the rate of change in the amount of circulating blood due to the most recent infusion of the replenisher measured by the measurement unit. Adjusting the next infusion amount and / or infusion interval of the replenisher so as to collect at least the water equivalent to the entire amount of the replenisher to be injected into the blood circuit from the start to the end of the dialysis. A dialysis device that controls the water removal speed of the purification means.
The dialysis apparatus according to claim 1, wherein the blood purification means and the dialysate circuit are used as the replenisher injection means, and a dialysate back-filtered by the blood purification means is used as the replenisher.
Blood circuit,
A blood purification means arranged in the blood circuit and capable of removing water in blood,
The blood purification means is connected, and a dialysate circuit for introducing and extracting a dialysate,
Measuring means for measuring the rate of change of circulating blood volume,
A replenisher injecting means for injecting a replenisher for restoring a circulating blood volume reduced by water removal into the blood circuit,
A control unit that controls the replenisher injection means so as to inject a predetermined amount of replenisher intermittently at predetermined intervals in the blood circuit, and a replenisher control method using a dialysis device,
Using the rate of change measured by the measuring means to calculate the rate of change in circulating blood volume due to the injection of the latest replenisher,
Based on the change rate, adjust the next injection amount and / or injection interval of the replenisher so that the change rate of the circulating blood volume due to the next injection of the replenisher is within a predetermined range,
A replacement fluid control method for controlling a water removal rate of the blood purification means so as to collect at least water corresponding to a total amount of a replenisher to be injected into the blood circuit from the start to the end of dialysis.
If the rate of change of the circulating blood volume due to the injection of the latest replenisher is within the predetermined range, the next injection amount of the replenisher is the same as the latest injection amount,
If the change rate is larger than the predetermined range, the next injection amount of the replenisher is set to an amount smaller than the latest injection amount according to the change rate,
4. The replacement fluid control method according to claim 3, wherein if the rate of change is smaller than the predetermined range, the next injection amount of the replenisher is set to be larger than the latest injection amount in accordance with the change rate. 5.
If the rate of change of the circulating blood volume due to the injection of the latest replenishment solution is within the predetermined range, the interval until the next replenishment solution is injected is a predetermined infusion interval,
If the change rate is larger than the predetermined range, the interval until the next replenisher is injected according to the change rate is longer than the predetermined injection interval,
If the change rate is smaller than the predetermined value, the interval until the next replenishment solution is injected according to the change rate is shorter than the predetermined injection interval,
Controlling the water removal rate of the blood purification means so as to collect water corresponding to the injection amount of the recently injected replenisher between the injection of the latest replenisher and the next injection of the replenisher. Item 6. A replacement fluid control method according to Item 3.
補 The fluid replacement control method according to any one of claims 3 to 5, wherein the predetermined range is 5 to 10%.