CN112312941B - Dialysis device and fluid replacement control method - Google Patents

Dialysis device and fluid replacement control method Download PDF

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Publication number
CN112312941B
CN112312941B CN201980042057.9A CN201980042057A CN112312941B CN 112312941 B CN112312941 B CN 112312941B CN 201980042057 A CN201980042057 A CN 201980042057A CN 112312941 B CN112312941 B CN 112312941B
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replenishment liquid
blood
injection
rate
amount
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CN112312941A (en
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长尾寻智
正冈胜则
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JMS Co Ltd
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JMS Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/34Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits

Abstract

The invention provides a dialysis device and a fluid replacement control method capable of implementing proper fluid replacement. The dialysis apparatus 100 includes a blood circuit 110, a blood purification unit 120, a dialysate circuit 130, a circulating blood volume measurement unit 140, a replenishment liquid injection unit for injecting replenishment liquid for recovering the circulating blood volume into the blood circuit, and a control unit 150 for controlling the replenishment liquid injection unit so that the replenishment liquid is intermittently injected into the blood circuit at predetermined intervals, wherein the control unit adjusts the injection amount and/or the injection interval of the next replenishment liquid so that the rate of change of the circulating blood volume due to the injection of the next replenishment liquid falls within a predetermined range based on the rate of change of the circulating blood volume due to the latest replenishment liquid injection measured by the measurement unit, and controls the water removal rate of the blood purification unit so that water corresponding to the total amount of the replenishment liquid injected into the blood circuit is recovered during a period from the start to the end of dialysis.

Description

Dialysis device and fluid replacement control method
Technical Field
The present invention relates to a dialysis apparatus and a fluid replacement control method using the same.
Background
In the dialysis treatment, the following operations were performed: the blood is taken out from the arterial side of the patient by a pump, and sent to a blood purifying unit such as a dialyzer or hemodiafiltration device, and the blood from which the waste and excessive moisture have been removed is returned to the arterial side of the patient.
In general, in dialysis treatment, blood is purified in about 4 hours for 1 treatment, and the blood is purified and the excessive water in the body is removed as the dialysis time elapses. Since the amount of circulating blood flowing through the body of the patient is gradually reduced by this blood purification, it is not uncommon for patients to develop symptoms of blood pressure drop in the latter half of the dialysis treatment.
When the circulating blood volume is reduced, peripheral blood vessels are contracted by the action of autonomic nerves in a normal biological reaction, and the circulating blood volume on the central side can be maintained. In addition, when blood is concentrated by removing water, plasma refill occurs in which plasma components migrate from the interstitium into the blood vessel due to an osmotic pressure difference, and the circulating blood volume can be maintained. However, such a biological reaction may not be performed normally by the patient, and it may be difficult to continue the dialysis treatment due to a decrease in blood pressure.
In order to rapidly increase the circulating blood volume when such a symptom of blood pressure drop is involved, treatment such as replacement of blood with physiological saline or a cleansed dialysate is performed.
In recent years, in order to prevent the occurrence of a drop in blood pressure due to a decrease in the amount of circulating blood caused by water removal, for example, in hemodialysis (so-called HD) and hemodiafiltration (so-called HDF) treatments, it has been proposed to repeatedly perform 150 ml to 200 ml of fluid replacement every 30 minutes, and to perform a "intermittent replenishment type hemodiafiltration method" in which water in an amount corresponding to the fluid replacement is added to the original water removal amount (see non-patent documents 1 and 2).
Prior art literature
Non-patent literature
Non-patent document 1 examination paper for New HDF therapy and its clinical Effect in Japanese journal of dialysis medical society, volume 40, pages No. 9-774 "
Non-patent document 2J dialysis medical society, journal 42, pages No. 9, 695-703 "examination paper for intermittent rehydration hemodialysis in automatic mode with reverse filtration of dialysate" clinical evaluation "
Disclosure of Invention
Problems to be solved by the invention
As described above, since the occurrence of blood pressure drop can be suppressed by performing the planned replacement of the fluid during the dialysis treatment, the conditions such as the base weight and the water removal amount are different depending on the patient, and therefore, it is considered that the proper replacement fluid injection amount and the injection interval for stabilizing the blood pressure are different. In addition, even in the same patient, the circulatory dynamics of blood (the circulating blood volume, the speed of plasma refill, etc.) change during the course of the dialysis treatment. Therefore, if the fluid replacement is performed under the uniform condition regardless of the patient's condition, a sudden increase in blood pressure may occur due to excessive fluid replacement, and an effect of suppressing a sudden decrease in blood pressure may not be sufficiently obtained due to insufficient fluid replacement.
Accordingly, an object of the present invention is to provide a dialysis apparatus and a fluid replacement control method capable of properly replenishing fluid.
Means for solving the problems
The present invention relates to a dialysis device, comprising: a blood circuit; a blood purification unit which is disposed in the blood circuit and which can remove moisture in blood; a dialysate circuit connected to the blood purification unit and configured to introduce and discharge dialysate into and from the blood purification unit; a measurement unit that measures a rate of change in the amount of circulating blood; a replenishment liquid injection unit that injects a replenishment liquid for recovering the circulating blood volume reduced by water removal into the blood circuit; and a control unit that controls the replenishment liquid injection means so that a predetermined amount of replenishment liquid is intermittently injected into the blood circuit at predetermined intervals, wherein the control unit adjusts the injection amount and/or the injection interval of the next replenishment liquid so that the rate of change of the amount of circulating blood caused by the next replenishment liquid injection falls within a predetermined range based on the rate of change of the amount of circulating blood caused by the latest replenishment liquid injection measured by the measurement means, and wherein the control unit controls the water removal rate of the blood purification means so that at least water corresponding to the total amount of replenishment liquid injected into the blood circuit is recovered during a period from the start to the end of dialysis.
In addition, it is preferable that the blood purification unit and the dialysate circuit are used as the replenishment liquid injection unit, and that the dialysate reversely filtered by the blood purification unit is used as the replenishment liquid.
The present invention also relates to a fluid replacement control method using a dialysis apparatus including: a blood circuit; a blood purification unit which is disposed in the blood circuit and which can remove moisture in blood; a dialysate circuit connected to the blood purification unit and configured to introduce and remove dialysate; a measurement unit that measures a rate of change in the amount of circulating blood; a replenishment liquid injection unit for injecting a replenishment liquid for recovering the circulating blood volume reduced by water removal into the blood circuit; and a control unit that controls the replenishment liquid injection means so that a predetermined amount of replenishment liquid is intermittently injected into the blood circuit at predetermined intervals, wherein in the replenishment liquid control method, a change rate of the circulating blood volume due to the latest replenishment liquid injection is calculated based on the change rate measured by the measurement means, and the injection amount and/or the injection interval of the next replenishment liquid are adjusted so that the change rate of the circulating blood volume due to the next replenishment liquid falls within a predetermined range based on the change rate, so that the water removal rate of the blood purification means is controlled so that at least water corresponding to the total amount of the replenishment liquid injected into the blood circuit is recovered during a period from the start to the end of dialysis.
Further, it is preferable that if the rate of change of the circulating blood volume due to the latest replenishment liquid injection is within the predetermined range, the injection amount of the next replenishment liquid is equal to the latest injection amount, if the rate of change is greater than the predetermined range, the injection amount of the next replenishment liquid is smaller than the latest injection amount, and if the rate of change is smaller than the predetermined range, the injection amount of the next replenishment liquid is larger than the latest injection amount, based on the rate of change.
Further, it is preferable that if the rate of change of the circulating blood volume due to the latest replenishment liquid injection is within the predetermined range, the interval until the next replenishment liquid injection is set to a predetermined injection interval, if the rate of change is larger than the predetermined range, the interval until the next replenishment liquid injection is made longer than the predetermined injection interval according to the rate of change, and if the rate of change is smaller than the predetermined value, the interval until the next replenishment liquid injection is made shorter than the predetermined injection interval according to the rate of change, and the water removal rate of the blood purification unit is controlled so that the water corresponding to the injection volume of the latest replenishment liquid injected is recovered as an amount corresponding to the recovery of the replenishment liquid during the period from the latest replenishment liquid injection to the next replenishment liquid injection.
Preferably, the predetermined range is 5% to 10%.
ADVANTAGEOUS EFFECTS OF INVENTION
According to the present invention, since an appropriate fluid replacement according to the circulation dynamics of blood during dialysis treatment can be performed, abrupt blood pressure fluctuations can be reduced.
Drawings
Fig. 1 is a diagram showing a schematic configuration of a dialysis apparatus.
Fig. 2 is a diagram showing a dialysis process performed by a dialysis apparatus.
Fig. 3 is a diagram showing a fluid replacement process performed by the dialysis apparatus.
Fig. 4 is a graph showing the rate of change of the circulating blood volume in the case where the fluid replacement is performed during dialysis.
Fig. 5 is a flowchart for explaining the fluid replacement control method according to the present invention.
Fig. 6 is a flowchart for explaining a method of setting the fluid replacement condition according to embodiment 1.
Fig. 7 is a diagram for explaining a method of injecting and recovering the replenishment liquid according to embodiment 1.
Fig. 8 is a diagram for explaining another method for injecting and recovering the replenishment liquid according to embodiment 1.
Fig. 9 is a flowchart for explaining a method of setting the fluid replacement condition according to embodiment 2.
Fig. 10 is a diagram for explaining a method of injecting and recovering the replenishment liquid according to embodiment 2.
Detailed Description
Hereinafter, preferred embodiments of the dialysis apparatus and the fluid replacement control method according to the present invention will be described with reference to the accompanying drawings.
The fluid replacement control method of the present invention can be applied to a case where fluid replacement is intermittently performed during dialysis treatment such as hemodialysis (so-called HD) and hemodiafiltration (so-called HDF). As an application example of the present invention, a case will be described in which intermittent replenishment hemodiafiltration is performed in which replenishment is intermittently performed by using a dialysate subjected to reverse filtration.
Embodiment 1
Fig. 1 is a diagram showing a schematic configuration of a dialysis apparatus 100 according to embodiment 1 of the present invention.
As shown in fig. 1, the dialysis apparatus 100 includes a blood circuit 110 through which blood flows, a blood purification unit 120, a dialysate circuit 130, a circulating blood volume measurement unit 140 disposed in the blood circuit 110, and a control unit 150.
The blood circuit 110 includes an arterial line 111, a venous line 112, a drug line 113, and a priming discharge line 114. The arterial line 111, the venous line 112, the drug line 113, and the pre-flush fluid discharge line 114 are each composed mainly of a flexible soft tube through which a liquid can flow.
One end of the arterial-side line 111 is connected to a blood inlet 122a of a blood purification unit 120 described later. An arterial-side connection portion 111a, an arterial-side bubble detector 111b, a blood pump 111c, and a circulating blood volume measuring unit 140 described below are disposed in the arterial-side line 111.
The arterial-side connection portion 111a is disposed on the other end side of the arterial-side line 111. A needle for puncturing a blood vessel of a patient is connected to the arterial-side connection portion 111 a.
The arterial side bubble detector 111b detects the presence or absence of bubbles in the tube.
The blood pump 111c is disposed downstream of the arterial-side bubble detector 111b in the arterial-side line 111. The blood pump 111c feeds out the liquid such as blood and pre-flush liquid in the arterial line 111 by rolling the tube constituting the arterial line 111.
One end of the vein-side tube 112 is connected to a blood outlet 122b of the blood purifying unit 120 described later. The vein-side line 112 is provided with a vein-side connection portion 112a, a vein-side bubble detector 112b, a drip chamber 112c, and a vein-side clip 112d.
The vein-side connection portion 112a is disposed on the other end side of the vein-side tube. A needle for puncturing a blood vessel of a patient is connected to the vein-side connection portion 112 a.
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 112 b. The drip chamber 112c stores a predetermined amount of blood for removing bubbles, coagulated thrombus, clot, and the like mixed in the vein-side tube 112 and for measuring the vein pressure.
The vein-side clip 112d is disposed downstream of the vein-side bubble detector 112 b. The vein side clamp 112d is controlled based on the bubble detection result by the vein side bubble detector 112b, and opens and closes the flow path of the vein side tube 112.
The medicine line 113 supplies the arterial line 111 with a medicine necessary for hemodialysis. The drug line 113 has one end connected to a drug pump 113a for delivering a drug, and the other end connected to the arterial line 111. The medicine line 113 is provided with a gripping means, not shown, and the flow path is closed by the gripping means except for the injection of the medicine. In the present embodiment, the other end of the chemical line 113 is connected to the arterial line 122 at a position upstream of the circulating blood volume measuring unit 140.
The pre-flush discharge line 114 is connected to the drip chamber 112c. A clip 114a for the pre-flushing liquid discharge line is disposed in the pre-flushing liquid discharge line 114. The pre-flushing liquid discharge line 114 is a line for discharging the pre-flushing liquid in a pre-flushing process described later.
The blood purification unit 120 includes a container body 121 formed in a tubular shape, and a dialysis membrane (not shown) housed in the container body 121, and the interior of the container body 121 is partitioned into a blood-side channel and a dialysate-side channel (both not shown) by the dialysis membrane. The container body 121 is formed with a blood inlet 122a and a blood outlet 122b that communicate with the blood circuit 110, and a dialysate inlet 123a and a dialysate outlet 123b that communicate with the dialysate circuit 130.
With the blood circuit 110 and the blood purification unit 120 described above, blood taken out from an artery of a subject (dialysis patient) is circulated through the arterial-side line 111 by the blood pump 111c, and introduced into the blood-side flow path of the blood purification unit 120. The blood introduced into the blood purification unit 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 unit 120 flows through the vein-side tube 112 and returns to the vein of the subject.
The dialysate circuit 130 is configured by a dialysate circuit 130 of a so-called closed-volume control system in the present embodiment. The dialysate circuit 130 includes a dialysate supply line 131a, a dialysate drain line 131b, a dialysate introduction line 132a, a dialysate discharge line 132b, and a dialysate delivery unit 133.
The dialysate feeding portion 133 includes a dialysate chamber 1331, a bypass line 1332, and a water removal/reverse filtration pump 1333.
The dialysate chamber 1331 is constituted by a hard container capable of containing a constant volume (for example, 300 ml to 500 ml) of dialysate, and the inside of the container is partitioned into a liquid-feeding container 1331a and a liquid-discharging container 1331b by a soft diaphragm (partition film).
The bypass line 1332 connects the dialysate extraction line 132b with the dialysate drainage line 131 b.
A water removal/reverse filtration pump 1333 is disposed in the bypass line 1332. The water removal/reverse filtration pump 1333 is configured by a pump that is driven so as to be capable of feeding the dialysate in the bypass line 1332 in a direction (water removal direction) to flow the dialysate toward the dialysate discharge line 131b and in a direction (reverse filtration direction) to flow the dialysate toward the dialysate discharge line 132 b.
The dialysate supply line 131a is connected to a dialysate supply device (not shown) at its base end side and to a dialysate chamber 1331 at its tip end side. The dialysate supply line 131a supplies dialysate to the liquid supply housing 1331a of the dialysate chamber 1331.
The dialysate introduction line 132a connects the dialysate chamber 1331 and the dialysate introduction port 123a of the blood purification unit 120, and introduces the dialysate stored in the liquid-sending storage part 1331a of the dialysate chamber 1331 into the dialysate-side flow path of the blood purification unit 120.
The dialysate discharge line 132b connects the dialysate discharge port 123b of the blood purification unit 120 and the dialysate chamber 1331, and discharges the dialysate discharged from the blood purification unit 120 to the drain housing portion 1331b of the dialysate chamber 1331.
The dialysate drain line 131b is connected to the dialysate chamber 1331 at its base end side, and drains the dialysate stored in the drain storage portion 1331b.
By dividing the inside of the hard container constituting the dialysate chamber 1331 by the soft diaphragm (partition film) in the dialysate circuit 130 described above, the amount of the dialysate discharged from the dialysate chamber 1331 (the amount of the dialysate supplied to the liquid-feeding-portion 1331 a) and the amount of the drain collected into the dialysate chamber 1331 (the drain-receiving portion 1331 b) can be made equal.
Thus, the flow rate of the dialysate introduced into the blood purification unit 120 can be equal to the amount of the dialysate (drain) discharged from the blood purification unit 120 in a state where the water removal/reverse filtration pump 1333 is stopped.
When the water removal/reverse filtration pump 1333 is driven to feed the liquid in the reverse filtration direction, a part of the drain liquid discharged from the dialysate chamber 1331 is again collected into the dialysate chamber 1331 through the bypass line 1332 and the dialysate discharge line 132 b. Therefore, the amount of the dialysate led out from the blood purification unit 120 is obtained by subtracting the amount of the dialysate flowing through the bypass line 1332 from the amount recovered in the dialysate chamber 1331 (i.e., the amount of the dialysate flowing through the dialysate introduction line 132 a). As a result, the amount of the dialysate led out from the blood purification unit 120 becomes smaller than the flow rate of the dialysate flowing through the dialysate introduction line 132a by an amount corresponding to the amount of the dialysate (drain) recovered again in the dialysate chamber 1331 through the bypass line 1332. That is, when the water removal/reverse filtration pump 1333 is driven to feed the liquid in the reverse filtration direction, a predetermined amount of dialysate is injected (reverse-filtered) into the blood circuit 110 in the blood purification unit 120 (see fig. 3).
Thus, in the present embodiment, the blood purification unit 120 and the dialysate circuit 130 (the water removal/reverse filtration pump 1333) are used as the replenishment liquid injection unit, and the dialysate after reverse filtration is used as the replenishment liquid. In other words, the dialysate as the replenishment liquid is injected from the dialysate circuit 130 into the blood circuit 110 through the blood purification unit 120 by driving the water removal/reverse filtration pump 1333 in the reverse filtration direction. The blood circuit 110 may be connected to a replenishment liquid line to serve as a replenishment liquid injection means, and physiological saline or the like may be used as a replenishment liquid. The replenishment liquid line provided with the replenishment liquid pump may be connected to the arterial line 111 or the venous line 112 from the dialysate introduction line 132a as a replenishment liquid injection means, and the dialysate may be used as a replenishment liquid.
On the other hand, when the water removal/reverse filtration pump 1333 is driven so as to feed the liquid in the water removal direction, the amount of the dialysate flowing through the dialysate outlet line 132b is obtained by adding the amount of the dialysate flowing through the bypass line 1332 to the amount of the dialysate recovered in the dialysate chamber 1331 (that is, the amount of the dialysate flowing through the dialysate inlet line 132 a). Accordingly, the amount of the dialysate flowing through the dialysate introduction line 132b is larger than the amount of the dialysate flowing through the dialysate introduction line 132a by an amount corresponding to the amount of the dialysate (drain) discharged to the dialysate drain line 131b through the bypass line 1332. That is, when the water removal/reverse filtration pump 1333 is driven to feed the liquid in the water removal direction, a predetermined amount of water is removed from the blood in the blood purification unit 120 (see fig. 2).
The circulating blood volume measuring unit 140 is a sensor that measures the hematocrit value of blood flowing in the blood circuit 110. For example, the hematocrit value can be measured based on the transmittance of blood obtained by irradiating the blood with near-infrared rays. The rate of change of the circulating blood volume in the patient can be calculated based on the hematocrit value measured by the circulating blood volume measuring unit 140 over time. As shown in fig. 1, the circulating blood volume measuring unit 140 is disposed in the arterial line 111 downstream of the blood pump 11c and upstream of the blood purifying unit 120 so as not to be easily affected by water removal and fluid replacement by the blood purifying unit 120.
The control unit 150 is configured by an information processing device (computer), and controls the operation of the dialysis apparatus 100 by executing a control program. The control unit 150 calculates the rate of change 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, clamps, and the like disposed in the blood circuit 110 and the dialysate circuit 130, and performs various processes performed by the dialysis apparatus 100, for example, a priming process, a exsanguination process, a dialysis process, a fluid replacement process, and a blood return process.
Various steps will be briefly described with reference to fig. 2 and 3.
In the priming step, the blood circuit 110 and the blood purification unit 120 are cleaned by using the reverse-filtered dialysate as a priming solution.
In the blood removing step, the blood of the patient is sucked to fill the arterial line 111 and the venous line 112 with the blood. After the blood removing step, a dialysis step (see fig. 2) is performed to purify the blood and remove moisture. In the dialysis step, the residual water of the patient is removed, and water removal corresponding to the recovery of the fluid replacement is also performed.
The fluid replacement step is intermittently performed during the dialysis step (see fig. 3). After the dialysis process is completed, a blood return process for returning blood to the patient is performed.
The dialysis process and the fluid replacement process, which are related to the change in the circulating blood volume, among the various processes performed by the dialysis apparatus 100 will be described in detail below.
The dialysis process will be described with reference to fig. 2.
In the dialysis process, the blood of the patient introduced from the arterial side connection portion 111a is purified by the blood purification unit 120 through the arterial side line 111, and returned to the patient from the venous side connection portion 112a through the venous side line 112.
In the dialysis step, as shown in fig. 2, the arterial-side connection portion 111a and the venous-side connection portion 112a are connected to needles that pierce the blood vessel of the patient, respectively, and the pre-flush line clamp 114a is in a clamped state and the venous-side clamp 112d is in an open state.
A dialysate supply device, not shown, supplies and discharges dialysate to and from the dialysate chamber 1331 in an average amount of 500 ml/min, and causes the water removal/reverse filtration pump 1333 to operate so as to supply liquid in the water removal direction. As an example, the amount of water to be fed to the water removal/reverse filtration pump 1333 is set to 10 ml/min, and water removal is performed in the blood purification unit 120 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 process to, for example, about 200 ml/min, and sends blood from the arterial side connection portion 111a to the blood purification unit 120.
In the blood purification unit 120, blood flows in at a flow rate of 200 ml/min from the blood inlet 122a, water is removed at a flow rate of 10 ml/min, and the blood is discharged at a flow rate of 190 ml/min from the blood outlet 122b. The dialysate drain is led out from the dialysate outlet 123b.
In this way, the water is gradually removed from the blood in the dialysis step, and the amount of circulating blood gradually decreases in association with this.
Next, the fluid replacement process will be described with reference to fig. 3.
The fluid replacement step is a step of injecting a reverse-filtered dialysate into the blood circuit 110, and in this embodiment, the fluid replacement step is intermittently performed at predetermined intervals in order to prevent a decrease in blood pressure or the like due to a decrease in the amount of circulating blood caused by water removal.
In the fluid replacement step, as shown in fig. 3, the arterial-side connecting portion 111a and the venous-side connecting portion 112a are connected to needles that pierce blood vessels of a patient, respectively, and the pre-flush line clamp 114a is in a clamped state and the venous-side clamp 112d is in an open state, as in the dialysis step.
A dialysate supply device, not shown, supplies and discharges dialysate to and from the dialysate chamber 1331 in an average amount of 500 ml/min, and causes the water removal/reverse filtration pump 1333 to operate so as to supply liquid in the reverse filtration direction. For example, in the case of replenishing 200 ml, the feeding amount of the water removal/reverse filtration pump 1333 is set to 150 ml/min, for example, so that the blood purification unit 120 is replenished with 150 ml/min for about 80 seconds.
The blood pump 111c gradually reduces the flow rate from 200 ml/min to about 50 ml/min in the dialysis process, and sends out blood from the arterial side connection portion 111a side to the blood purification unit 120 side.
In the blood purification unit 120, blood flows in from the blood inlet 122a at a flow rate of 50 ml/min, the reverse-filtered dialysate is replenished at a flow rate of 150 ml/min, and diluted blood is discharged from the blood outlet 122b at a flow rate of 200 ml/min. In this way, the dialysate is rapidly replenished into the blood in about 80 seconds in the replenishing step.
Next, a specific fluid replacement control method according to the present embodiment will be described with reference to fig. 4 to 8.
First, the effect obtained by intermittently performing the fluid replacement will be briefly described.
During dialysis treatment, as water removal proceeds, water (plasma) in the blood is gradually removed, and the circulating blood volume gradually decreases. When the circulating blood volume decreases and the protein concentration in the blood increases, the water (plasma) gradually moves from the interstitium into the blood vessel (plasma refill) due to the osmotic pressure difference between the intravascular and extravascular (interstitium), and the circulating blood volume is restored and the blood pressure is maintained. However, when the blood pressure continues to decrease as the rate of plasma refill does not follow the rate of water removal and the amount of circulating blood decreases, a biological response occurs in which peripheral blood vessels contract due to the action of autonomic nerves to maintain blood pressure. If it does not work properly, the rate of plasma refill will be significantly lower than the rate of water removal and the rate of reduction of the circulating blood volume will be greater, resulting in a dramatic drop in blood pressure.
In order to prevent such a rapid blood pressure drop, fluid replacement is intermittently performed. By performing dialysis while restoring the blood circulation volume by replenishing the blood, the blood pressure is prevented from decreasing, peripheral circulation is improved, and the rate of plasma refill is maintained. As a result, the rate of decrease in the circulating blood volume after the end of dialysis can be reduced even at the same water removal rate (except for the amount of the recovered fluid) as compared with the case where no fluid replacement is performed. The blood purification unit 120 removes water from the dialysis start to the end due to the increased amount of the circulating blood volume caused by the administration of the replacement fluid. Thus, the total water removal amount is the sum of the residual water content (water removal amount according to the body weight) of the patient and the amount according to the fluid replacement recovery.
In order to sufficiently obtain the above-described effects obtained by performing the fluid replacement, the present invention can perform the fluid replacement at an appropriate injection amount and injection interval.
Next, a change in the amount of circulating blood when the fluid replacement is performed under normal conditions will be described.
Fig. 4 is a graph showing the rate of change of the circulating blood volume in the case where the fluid replacement is performed at an injection amount of 200 ml and an injection interval of 30 minutes, which is normally performed. As shown in fig. 4, the circulating blood volume was increased by the fluid replacement at intervals of 30 minutes.
It is considered that the rate of increase in the circulating blood volume obtained by this replacement fluid depends on the volume of replacement fluid from the outside of the body and the amount of movement of plasma into the blood vessel due to the in vivo plasma refill. The rate of the plasma refill varies from patient to patient and also varies during dialysis, so that the amount of the appropriate replenishment liquid to be injected varies for each replenishment liquid application. In the case of the present embodiment, since the blood purification unit 120 is not used to remove water during the injection of the replenishment liquid, the amount of reduction due to water removal may be eliminated.
The present inventors have studied the injection amount of an appropriate replacement fluid, and as a result, it is considered that the rate of change (rate of rise) of the circulating blood volume achieved by 1 replacement fluid administration is preferably in the range of 5 to 10%. If the rate of change exceeds 10%, the circulation blood volume increases rapidly, and a rapid increase in blood pressure may occur. In the case of a patient suffering from a heart disease, the load due to the rise in blood pressure increases, so that the upper limit of the rate of change may be set to a value lower than 10% to reduce the amount of the replenishment liquid injected each time and increase the number of injections. If the injection amount of the fluid replacement is excessive, the amount of water removed in accordance with the recovery of the fluid replacement increases, and the total amount of water removed increases as a result of the addition of the residual water of the patient. As a result, the water removal rate increases, and the risk of lowering blood pressure increases. If the rate of change is less than 5%, the aforementioned effect obtained by the fluid replacement cannot be sufficiently obtained.
Therefore, a method of controlling the injection amount of the replenishment liquid so that the rate of change in the circulating blood volume achieved by the replenishment liquid is in the range of 5 to 10% will be described.
(method for controlling the 1 st make-up liquid)
In this embodiment, a case where the total of 7 fluid supplements is performed during a treatment period of 4 hours with a constant infusion interval of 30 minutes will be described with reference to fig. 5 and 6 as an example.
The control unit 150 measures the hematocrit value by the circulating blood volume measuring means 140, and calculates the rate of change of the circulating blood volume with time based on the measured hematocrit value.
For example, the 1 st replenishment liquid can be determined based on the patient's basic body weight. For example, a patient having a basic weight of 50 kg or more may be given a 1-time replenishment liquid amount of 200 ml, and a patient having a weight of less than 50 kg may be given a replenishment liquid injection amount of 150 ml or the like.
The flow of the dialysis treatment will be described with reference to fig. 5.
The dialysis apparatus 100 performs water removal at a predetermined rate after the start of dialysis (S100). After a predetermined time has elapsed (S110), the fluid is replenished in a predetermined injection amount (S120).
Whether or not the last replacement fluid is determined (S130), and if not, the next replacement fluid condition is set based on the rate of change (rate of rise) of the last circulating blood volume (S140). If the last fluid replacement is performed, the 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 is a water removal rate at the start of the dialysis treatment set based on the amount of water (water removal amount) to be removed from the patient by the dialysis treatment. The predetermined dialysis time in S160 is also referred to as a water removal time at the start of the dialysis treatment.
A method of setting the fluid replacement condition will be described with reference to fig. 6.
The change rate of the circulating blood volume before and after the start of the injection of the replenishment liquid by the latest replenishment liquid administration is calculated (S141), and it is determined whether or not the change rate due to the replenishment liquid falls within a predetermined range (S142). When the rate of change due to the replenishment liquid is within the range of 5 to 10%, it is determined that the injection amount of the replenishment liquid is an appropriate amount, and the replenishment liquid is performed at the same injection amount as the 1 st time after the next 30 minutes (S143). If the rate of change due to the fluid replacement exceeds 10%, it is determined that the injection amount is excessive, and the injection amount of the fluid replacement after the next 30 minutes is set to a reduced amount (S144). Specifically, the larger the rate of change of the circulating blood volume, the smaller the amount of the fluid replacement to be injected, and the injection amount of the fluid replacement may be subtracted by a predetermined ratio regardless of the rate of change of the circulating blood volume. For example, the amount of replacement fluid to be subtracted is calculated by calculating the ratio of the actual rate of change to the upper limit of the rate of change of the circulating blood volume by 10% and multiplying the calculated ratio by the initial 200 ml of replacement fluid volume. In the above example, when the rate of change in the circulating blood volume due to the replacement fluid exceeds the predetermined range, the control is performed so as to change both the injection volume and the injection interval of the replacement fluid, but the control may be performed so as to change only one of the two without changing the other.
If the rate of change due to the fluid replacement is smaller than 5%, it is determined that the injection amount is too small, and the injection amount of the fluid replacement after the next 30 minutes is set to be increased (S145). Specifically, the smaller the rate of change of the circulating blood volume, the larger the amount of fluid replacement to be injected, and the larger the amount of fluid replacement to be injected by a certain ratio may be, regardless of the rate of change of the circulating blood volume. For example, the amount of replacement fluid to be added is calculated by calculating the ratio of the actual rate of change to the upper limit of the rate of change of the circulating blood volume by 10%, and multiplying the calculated ratio by the initial 200 ml of replacement fluid volume.
In this way, the control unit 150 adjusts the injection amount of the next replenishment liquid so that the rate of change of the circulating blood volume due to the next replenishment liquid becomes in the range of 5 to 10% based on the rate of change of the circulating blood volume due to the latest replenishment liquid.
The amount of the circulating blood that increases due to the replenishment liquid may be recovered by adjusting the water removal rate from the beginning to the end of the dialysis, and in this embodiment, as shown in fig. 7, the amount of the injected fluid in the latest fluid replacement is recovered by adding the remaining water (the water removal amount according to the body weight) of the patient until the next fluid replacement.
In addition, as for the recovery method of the amount increased by the replenishment liquid, as shown in fig. 8, recovery of the replenishment liquid may be performed not after the final replenishment liquid is performed but in advance before the final replenishment liquid is performed. In this case, the injection amount of the last fluid replacement is set to a predetermined amount and water removal is performed early regardless of the rate of change of the circulating blood volume due to the latest fluid replacement. Although the injection amount of the fluid replacement is shown to be constant for simplicity of explanation, in practice, the injection amount of the fluid replacement varies based on the rate of change in the circulating blood volume due to the latest fluid replacement, in addition to the final injection amount of the fluid replacement.
According to the dialysis apparatus 100 and the 1 st fluid replacement control method according to embodiment 1 described above, the following effects are achieved.
(1) The dialysis apparatus 100 is configured to include the following: a blood circuit 110; a blood purification unit 120; a dialysate circuit 130; a circulating blood volume measuring unit 140; a replenishment liquid injection unit for injecting a replenishment liquid into the blood circuit 110; control unit150, which is provided withAccording toThe replenishment liquid injection means is controlled so that a predetermined amount of replenishment liquid is intermittently injected into the blood circuit 110 at predetermined intervals, and the control unit 150 controls the water removal rate of the blood purification means 120 so that the rate of change of the circulating blood volume due to the next replenishment liquid injection falls within a predetermined range based on the rate of change of the circulating blood volume due to the latest replenishment liquid injection measured by the circulating blood volume measurement means 140, and so that the injection amount and the injection interval of the next replenishment liquid are adjusted so that at least water corresponding to the total amount of the replenishment liquid injected into the blood circuit 110 is recovered during a period from the start to the end of dialysis.
This makes it possible to achieve proper fluid replacement that dynamically matches the circulation of the patient's blood, so that it is possible to suppress a rapid increase in blood pressure due to fluid replacement and to suppress a decrease in blood pressure due to water removal. Thus, the blood pressure fluctuation during dialysis can be reduced, and dialysis treatment with reduced burden on the patient can be performed. In addition, by adjusting the injection amount of the fluid replacement so as not to be excessive, the water removal rate corresponding to the recovery of the fluid replacement can be reduced, and the occurrence of a drop in blood pressure due to an excessive water removal rate can be suppressed.
(2) The method for controlling the replenishment liquid using the dialysis apparatus 100 is configured such that the rate of change of the circulating blood volume caused by the latest replenishment liquid injection is calculated from the rate of change measured by the circulating blood volume measuring unit 140, and if the rate of change of the circulating blood volume caused by the latest replenishment liquid injection is within a predetermined range, the next replenishment liquid injection amount is equal to the latest injection amount, and if the rate of change is greater than the predetermined range, the next replenishment liquid injection amount is smaller than the latest injection amount based on the rate of change, and if the rate of change is smaller than the predetermined range, the next replenishment liquid injection amount is larger than the latest injection amount based on the rate of change.
Thus, when the amount of the latest infusion is appropriate, the infusion is performed in the same manner as the next time, and when the amount of the latest infusion is excessive, the amount of the next infusion is reduced, and when the amount of the latest infusion is too small, the amount of the next infusion is increased, so that the appropriate infusion can be achieved that dynamically matches the blood circulation of the patient.
< embodiment 2 >
Next, a method of controlling the 2 nd fluid replacement using the dialysis apparatus 100 described in embodiment 1 will be described with reference to fig. 9 and 10. In this embodiment, the difference is that the liquid replenishment control method 1 is different in that the injection interval of the liquid replenishment is not constant.
(2 nd fluid replacement control method)
In the present embodiment, the injection interval of the replenishment liquid serving as an example is set to 30 minutes, and the injection interval after the 2 nd time is adjusted based on the rate of change of the circulating blood volume caused by the latest replenishment liquid.
Since the flow of the dialysis treatment is the same as that described in embodiment 1, the description thereof is omitted, and the method of setting the fluid replacement condition is described with reference to fig. 9.
As shown in fig. 9, the change rate of the circulating blood volume before and after the start of the injection of the replenishment liquid by the latest replenishment liquid administration is calculated (S141), and it is determined whether or not the change rate due to the replenishment liquid falls within a predetermined range (S142). When the rate of change due to the replenishment liquid is within the range of 5% to 10%, it is determined that the injection amount of the replenishment liquid is an appropriate amount, the next replenishment liquid is made to be the same injection amount as the 1 st time, and the injection interval (30 minutes) from the next replenishment liquid is set as the reference injection interval (S146). If the rate of change due to the liquid replenishment exceeds 10%, it is determined that the injection amount is excessive, and the next liquid replenishment injection amount is set to a reduced amount, and the injection interval until the next liquid replenishment is made longer than the reference injection interval (30 minutes) (S147). Specifically, the injection interval may be made longer as the rate of change of the circulating blood volume increases, or the injection interval may be extended by a certain proportion regardless of the rate of change of the circulating blood volume. For example, the increase time of the injection interval is calculated by calculating the ratio of the actual change rate to the upper limit of the change rate of the circulating blood volume by 10% and multiplying the calculated ratio by the reference injection interval for 30 minutes.
If the rate of change due to the fluid replacement is smaller than 5%, it is determined that the injection amount is too small, and the injection amount of the next fluid replacement is increased, and the injection interval until the next fluid replacement is made shorter than the reference injection interval (30 minutes) (S148). Specifically, the injection interval may be made shorter as the rate of change of the circulating blood volume is smaller, or the injection interval may be shortened by a certain proportion regardless of the rate of change of the circulating blood volume. For example, the ratio of the actual change rate to the upper limit of the change rate of the circulating blood volume is calculated and the reference injection interval is multiplied by the calculated ratio for 30 minutes, thereby calculating the time for decreasing the injection interval.
In this way, the control unit 150 adjusts the injection amount of the next replenishment liquid and adjusts the injection interval until the next replenishment liquid so that the rate of change of the circulating blood volume due to the next replenishment liquid is in the range of 5% to 10% based on the rate of change of the circulating blood volume due to the latest replenishment liquid.
As shown in fig. 10, the injection amount of the final fluid replacement may be increased or decreased according to the dialysis remaining time after the final fluid replacement.
The amount of the circulating blood that increases due to the replenishment liquid may be collected by adjusting the water removal rate from the start to the end of the dialysis, and in this embodiment, the amount of the injection into the latest replenishment liquid is collected before the next replenishment liquid as in the case described in embodiment 1 (see fig. 10).
According to the 2 nd liquid supply control method of the 2 nd embodiment described above, the following effects are obtained in addition to the effects (1) and (2).
(3) The method of controlling the replenishment liquid using the dialysis apparatus 100 is configured such that if the rate of change of the circulating blood volume due to the latest replenishment liquid injection is within the predetermined range, the interval until the next replenishment liquid injection is set to a predetermined injection interval, if the rate of change is greater than the predetermined range, the interval until the next replenishment liquid injection is made longer than the predetermined injection interval based on the rate of change, if the rate of change is smaller than the predetermined range, the interval until the next replenishment liquid injection is made shorter than the predetermined injection interval based on the rate of change, and the water removal rate of the blood purification unit 120 is controlled such that the water corresponding to the injection volume of the latest replenishment liquid is recovered from the latest replenishment liquid injection until the next replenishment liquid injection.
In this way, when the amount of the latest infusion is excessive, the infusion interval to the next infusion is prolonged, so that the water removal rate corresponding to the infusion recovery can be reduced, and the occurrence of the blood pressure drop due to the excessive water removal rate can be suppressed.
While preferred embodiments of the dialysis apparatus and the fluid replacement control method according to the present invention have been described above, the present invention is not limited to the above-described embodiments, and may be appropriately modified.
For example, in the above-described embodiment, the case where the dialysate after the reverse filtration is used as the replenishment liquid has been described, but the normal saline may be used as the replenishment liquid, or the dialysate may be replenished from a dialysate line directly connected to the blood circuit without passing through the blood purification unit.
Description of the reference numerals
100. Dialysis device
110. Blood circuit
111. Arterial side pipeline
111c blood pump
112. Vein side pipeline
120. Blood purification unit
130. Dialysate circuit
140. Circulating blood volume measuring unit
150. Control unit

Claims (5)

1. A dialysis device is provided with:
a blood circuit;
a blood purification unit which is disposed in the blood circuit and which can remove moisture in blood;
a dialysate circuit connected to the blood purification unit and configured to introduce and discharge dialysate into and from the blood purification unit;
a measurement unit that measures a rate of change in the amount of circulating blood;
a replenishment liquid injection unit that injects a replenishment liquid for recovering the circulating blood volume reduced by water removal into the blood circuit; and
a control unit that controls the replenishment liquid injection means so that a predetermined amount of replenishment liquid is intermittently injected into the blood circuit at predetermined intervals,
the control unit adjusts the injection amount and/or the injection interval of the next replenishment liquid so that the rate of change of the circulating blood volume due to the next replenishment liquid injection falls within a predetermined range based on the rate of change of the circulating blood volume due to the latest replenishment liquid injection measured by the measurement unit, and the control unit controls the water removal rate of the blood purification unit so as to collect at least water corresponding to the total amount of the replenishment liquid injected into the blood circuit from the start to the end of dialysis.
2. The dialysis device of claim 1, wherein,
the blood purification unit and the dialysate circuit are used as the replenishment liquid injection unit, and the dialysate reversely filtered by the blood purification unit is used as the replenishment liquid.
3. The dialysis device of claim 1, wherein,
in the control unit, if the rate of change of the circulating blood volume due to the latest replenishment liquid injection falls within the predetermined range, the injection amount of the next replenishment liquid is set to be equal to the latest injection amount,
if the change rate is larger than the predetermined range, the injection amount of the next replenishment liquid is set to be smaller than the latest injection amount based on the change rate,
if the change rate is smaller than the predetermined range, the injection amount of the next replenishment liquid is set to an amount larger than the latest injection amount in accordance with the change rate.
4. The dialysis device of claim 1, wherein,
in the control unit, if the rate of change of the circulating blood volume due to the latest replenishment liquid injection falls within the predetermined range, the interval until the next replenishment liquid injection is set to a predetermined injection interval,
if the rate of change is greater than the predetermined range, the interval until the next injection of the replenishment liquid is made longer than the predetermined injection interval based on the rate of change,
if the change rate is smaller than the predetermined value, the interval until the next injection of the replenishment liquid is made shorter than the predetermined injection interval based on the change rate,
the water removal rate of the blood purification unit is controlled so that water corresponding to the amount of the replenishment liquid injected immediately before the next replenishment liquid injection is recovered from the latest replenishment liquid injection.
5. The dialysis device according to claim 3 or 4, wherein,
the prescribed range is 5% -10%.
CN201980042057.9A 2018-06-27 2019-06-27 Dialysis device and fluid replacement control method Active CN112312941B (en)

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