CN112312941A - Dialysis device and fluid infusion control method - Google Patents
Dialysis device and fluid infusion control method Download PDFInfo
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- CN112312941A CN112312941A CN201980042057.9A CN201980042057A CN112312941A CN 112312941 A CN112312941 A CN 112312941A CN 201980042057 A CN201980042057 A CN 201980042057A CN 112312941 A CN112312941 A CN 112312941A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/34—Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other 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 apparatus and a fluid replacement control method capable of implementing appropriate fluid replacement. The dialysis apparatus 100 comprises a blood circuit 110, a blood purification unit 120, a dialysate circuit 130, a circulating blood amount measurement unit 140, a replenishment solution infusion unit for infusing a replenishment solution for restoring the amount of circulating blood into the blood circuit, and a control unit 150 for controlling the replenishment solution infusion unit so as to intermittently infuse a predetermined amount of the replenishment solution into the blood circuit at predetermined intervals, wherein the control unit adjusts the infusion amount and/or infusion interval of the replenishment solution for the next time so that the change rate of the amount of circulating blood due to the infusion of the replenishment solution for the next time falls within a predetermined range on the basis of the change rate of the amount of circulating blood due to the latest replenishment solution infusion measured by the measurement unit, and recovers water corresponding to the total amount of the replenishment solution infused into the blood circuit during a period from the start to the end of dialysis, the speed of water removal by the blood purification unit is controlled.
Description
Technical Field
The present invention relates to a dialysis apparatus and a fluid replacement control method using the same.
Background
In dialysis treatment, the following operations are performed: blood is taken out from the artery side of the patient by a pump and sent to a blood purification unit such as a dialyzer or hemodiafiltration unit, and the blood from which waste products and excess water have been removed is returned to the artery side of the patient.
In general, in dialysis treatment, about 4 hours are consumed for 1 treatment to purify blood, and the blood is purified with the lapse of dialysis time, and excess water in the body is removed. Since this blood purification gradually reduces the amount of circulating blood flowing in the body of the patient, it is not uncommon for patients to develop a blood pressure drop during the latter half of the dialysis treatment.
When the amount of circulating blood decreases, peripheral blood vessels are contracted by the action of autonomic nerves in a normal biological reaction, and the amount of circulating blood on the central side can be maintained. Further, when the blood is concentrated by water removal, plasma refilling occurs in which the plasma component moves from the interstitium to the blood vessel due to the osmotic pressure difference, and the amount of circulating blood can be maintained. However, such a biological reaction may not be normally performed by the patient, and it may be difficult to continue the dialysis treatment due to a decrease in blood pressure.
When such a blood pressure drop occurs, in order to rapidly increase the amount of circulating blood, a treatment such as fluid replacement using physiological saline or a clean dialysate is performed on the blood.
In recent years, in order to prevent a decrease in blood pressure due to a decrease in the amount of circulating blood caused by water removal, in hemodialysis (so-called HD) and hemodiafiltration (so-called HDF) treatments, there has been proposed an "intermittent replenishment hemodiafiltration method" in which a replenishment solution of 150 ml to 200 ml is repeated every 30 minutes, and water is removed by adding the amount of water corresponding to the replenishment solution to the original amount of water removal (see non-patent document 1 and non-patent document 2).
Documents of the prior art
Non-patent document
Non-patent document 1 examination of New HDF therapy and clinical Effect thereof, pp.9-769 of Japanese society for dialysis and medicine, 40 "
Disclosure of Invention
Problems to be solved by the invention
As described above, it is considered that the conditions such as the basic body weight and the amount of removed water vary depending on the patient, and therefore, the injection amount and the injection interval of the replenishment solution suitable for stabilizing the blood pressure are different. In addition, even in the same patient, the circulation dynamics of blood (the amount of circulating blood, the speed of refilling plasma, etc.) change during the course of dialysis treatment. Therefore, if fluid replacement is performed under a condition that is not consistent regardless of the state of the patient, there is a possibility that fluid is excessively replaced to cause a rapid increase in blood pressure, and there is a possibility that fluid is insufficiently replaced to obtain an effect of suppressing a rapid decrease in blood pressure.
Accordingly, an object of the present invention is to provide a dialysis apparatus and a fluid replacement control method capable of performing appropriate fluid replacement.
Means for solving the problems
The present invention relates to a dialysis apparatus, 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 solution injection means for injecting a replenishment solution for restoring the amount of circulating blood reduced by the water removal into the blood circuit; and a control unit that controls the replenishment solution injection means so as to intermittently inject a predetermined amount of replenishment solution into the blood circuit at predetermined intervals, wherein the control unit adjusts the injection amount and/or the injection interval of the next replenishment solution so that the change rate of the amount of circulating blood due to the next replenishment solution injection falls within a predetermined range, based on the change rate of the amount of circulating blood due to the latest replenishment solution injection measured by the measurement unit, and wherein the control unit controls the water removal rate of the blood purification means so as to recover at least water corresponding to the entire amount of replenishment solution injected into the blood circuit from the start to the end of dialysis.
Preferably, the blood purification unit and the dialysate circuit are used as the replenishment liquid injection unit, and dialysate subjected to reverse filtration by the blood purification unit is used as the replenishment liquid.
Further, the present invention relates to a fluid replacement control method using a dialysis apparatus, the 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 for introducing and discharging dialysate; a measurement unit that measures a rate of change in the amount of circulating blood; a replenishment solution injection unit for injecting a replenishment solution for restoring the amount of circulating blood reduced by water removal into the blood circuit; and a control unit that controls the replenishment solution injection means so as to intermittently inject a predetermined amount of replenishment solution into the blood circuit at predetermined intervals, wherein the replenishment solution control method includes calculating a change rate of a circulating blood amount due to a latest replenishment solution injection based on the change rate measured by the measurement means, adjusting an injection amount and/or an injection interval of a next replenishment solution so that the change rate of the circulating blood amount due to a next replenishment solution injection falls within a predetermined range based on the change rate, and controlling a water removal rate of the blood purification means so as to recover at least water corresponding to a total amount of the replenishment solution injected into the blood circuit from a start to an end of dialysis.
Preferably, the amount of the next replenishment solution to be injected is equal to the latest amount to be injected if the rate of change of the amount of circulating blood due to the latest replenishment solution injection falls within the predetermined range, the amount of the next replenishment solution to be injected is smaller than the latest amount to be injected if the rate of change is larger than the predetermined range, and the amount of the next replenishment solution to be injected is larger than the latest amount to be injected if the rate of change is smaller than the predetermined range.
Preferably, if the rate of change of the amount of circulating blood resulting from the most recent refill injection is within the predetermined range, the interval until the next refill injection is set to a predetermined injection interval, if the rate of change is greater than the predetermined range, the interval until the next refill injection is made longer than the predetermined injection interval based on the rate of change, and if the rate of change is smaller than the predetermined value, the interval until the next refill injection is made shorter than the predetermined injection interval based on the rate of change, and the rate of water removal by the blood purification unit is controlled so that water corresponding to the amount of refill injected most recently is recovered as an amount corresponding to refill recovery during the period from the most recent refill injection to the next refill injection.
In addition, the predetermined range is preferably 5% to 10%.
ADVANTAGEOUS EFFECTS OF INVENTION
According to the present invention, since appropriate fluid replacement can be performed according to the circulation behavior of blood during dialysis treatment, rapid 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 the 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 in the amount of circulating blood when fluid replacement is performed during dialysis.
Fig. 5 is a flowchart for explaining the fluid replacement control method of the present invention.
Fig. 6 is a flowchart for explaining a method of setting fluid replacement conditions according to embodiment 1.
Fig. 7 is a diagram for explaining a method of injecting and recovering a replenishment liquid according to embodiment 1.
Fig. 8 is a diagram for explaining another method of injecting and recovering the replenishment liquid according to embodiment 1.
Fig. 9 is a flowchart for explaining a method of setting fluid replacement conditions according to embodiment 2.
Fig. 10 is a diagram for explaining a method of injecting and recovering a 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 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) or hemodiafiltration (so-called HDF). As an application example of the present invention, a case of performing intermittent replenishment hemodiafiltration in which replenishment is intermittently performed with a dialysate subjected to reverse filtration will be described.
< 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 amount measurement unit 140 disposed in the blood circuit 110, and a control unit 150.
The blood circuit 110 has 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 preflush discharge line 114 are each mainly composed of a flexible soft tube through which a liquid can flow.
One end side of the artery side tube 111 is connected to a blood introduction port 122a of a blood purification unit 120 described later. The artery side connection 111a, the artery side bubble detector 111b, the blood pump 111c, and a circulating blood amount measurement unit 140 described later are disposed in the artery side tube path 111.
The artery-side connecting portion 111a is disposed on the other end side of the artery-side channel 111. A needle for puncturing a blood vessel of a patient is connected to the artery-side connecting portion 111 a.
The artery-side bubble detector 111b detects the presence or absence of bubbles in the tube.
The blood pump 111c is disposed downstream of the artery-side bubble detector 111b in the artery-side tube 111. The blood pump 111c sends out a liquid such as blood and a pre-wash solution inside the artery side tube 111 by stroking the tube constituting the artery side tube 111 with rollers.
One end of the vein-side tube 112 is connected to a blood outlet 122b of the blood purification unit 120 described later. The vein-side tube 112 is provided with a vein-side connection portion 112a, a vein-side bubble detector 112b, a drip chamber (drip chamber)112c, and a vein-side clamp 112 d.
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 certain amount of blood in order to remove air bubbles, coagulated thrombi, coagulated blood clots, and the like mixed in the vein-side tube 112 and to measure the venous pressure.
The vein-side holder 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 drug line 113 supplies the arterial line 111 with a drug necessary for hemodialysis. The drug line 113 is connected at one end to a drug pump 113a for delivering a drug, and at the other end to the artery line 111. Further, a clamping unit, not shown, is provided in the drug tube 113, and the flow path is closed by the clamping unit except when the drug is injected. In the present embodiment, the other end of the drug 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 112 c. A preliminary flushing liquid discharge pipe clamp 114a is disposed in the preliminary flushing liquid discharge pipe 114. The preliminary flushing liquid discharge line 114 is a line for discharging the preliminary flushing liquid in the preliminary flushing step described later.
The blood purification unit 120 includes a container body 121 formed in a cylindrical shape, and a dialysis membrane (not shown) housed inside the container body 121, and the inside of the container body 121 is divided by the dialysis membrane into a blood-side channel and a dialysate-side channel (both not shown). The container body 121 is formed with 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.
With the blood circuit 110 and the blood purification unit 120 described above, blood taken out from the artery of the subject (dialysis patient) is introduced into the blood-side channel of the blood purification unit 120 while flowing through the artery-side line 111 by the blood pump 111 c. The blood introduced into the blood purification unit 120 is purified by dialysate flowing through a dialysate circuit 130 described later via a dialysate membrane. The blood purified by the blood purifying unit 120 flows through the vein-side line 112 and returns to the vein of the subject.
The dialysate circuit 130 is constituted 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 discharge line 131b, a dialysate introduction line 132a, a dialysate discharge line 132b, and a dialysate delivery unit 133.
The dialysate feed unit 133 includes a dialysate chamber 1331, a bypass line 1332, and a water removal/reverse filtration pump 1333.
The dialysate chamber 1331 is formed of a hard container capable of containing a predetermined volume (for example, 300 ml to 500 ml) of dialysate, and the interior of the container is divided into a liquid supply container 1331a and a liquid discharge container 1331b by a soft diaphragm (partition film).
The bypass line 1332 connects the dialysate extraction line 132b to the dialysate drain 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 can be driven so as to feed the dialysate in the bypass line 1332 in the direction (water removal direction) in which it flows toward the dialysate discharge line 131b and in the direction (reverse filtration direction) in which it flows toward the dialysate discharge line 132 b.
The dialysate supply line 131a is connected to a dialysate supply device (not shown) at its proximal end side and to the dialysate chamber 1331 at its distal end side. The dialysate supply line 131a supplies dialysate to the liquid supply container 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 supply container 1331a of the dialysate chamber 1331 into the dialysate-side flow path of the blood purification unit 120.
The dialysate extraction line 132b connects the dialysate extraction port 123b of the blood purification unit 120 and the dialysate chamber 1331, and extracts the dialysate extracted from the blood purification unit 120 into the drainage storage section 1331b of the dialysate chamber 1331.
The dialysate drain line 131b is connected to the dialysate chamber 1331 at its proximal end side, and drains the dialysate stored in the drain container 1331 b.
In the dialysate circuit 130 described above, the amount of dialysate drawn from the dialysate chamber 1331 (the amount of dialysate supplied to the liquid feed container portion 1331 a) and the amount of the drainage collected in the dialysate chamber 1331 (the drainage container portion 1331b) can be made equal by dividing the interior of the hard container constituting the dialysate chamber 1331 by the soft diaphragm (partition film).
Thus, in a state where the water removal/reverse osmosis pump 1333 is stopped, the flow rate of the dialysate introduced into the blood purification unit 120 can be equalized to the amount of the dialysate (drain) led out from the blood purification unit 120.
When the water removal/reverse osmosis pump 1333 is driven to send the liquid in the reverse osmosis direction, a part of the drain discharged from the dialysate chamber 1331 is collected again 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 collected in the dialysate chamber 1331 (i.e., the amount of the dialysate flowing through the dialysate introduction line 132 a). Thus, the amount of the dialysate led out from the blood purification unit 120 is 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) collected again in the dialysate chamber 1331 through the bypass line 1332. That is, when the water removal/reverse osmosis pump 1333 is driven so as to send the fluid in the reverse osmosis direction, a predetermined amount of the dialysate is injected (reverse-filtered) into the blood circuit 110 (see fig. 3) in the blood purification unit 120.
In this way, in the present embodiment, the blood purification unit 120 and the dialysate circuit 130 (the water removal/reverse filtration pump 1333) are used as a replenishment liquid injection unit, and the dialysate subjected to reverse filtration is used as a replenishment liquid. In other words, the dialysate as the replenishment liquid is injected from the dialysate circuit 130 into the blood circuit 110 via 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 and used as a replenishment liquid injection means, and a saline solution or the like may be used as the replenishment liquid. Further, a replenishment liquid line provided with a replenishment liquid pump may be connected from the dialysate introduction line 132a to the artery-side line 111 or the vein-side line 112 as a replenishment liquid injection means, and the dialysate may be used as the replenishment liquid.
On the other hand, when the water removal/reverse osmosis pump 1333 is driven so as to send the dialysate in the water removal direction, the amount of the dialysate flowing through the dialysate extraction line 132b is obtained by adding the amount of the dialysate collected in the dialysate chamber 1331 (i.e., the amount of the dialysate flowing through the dialysate introduction line 132 a) to the amount of the dialysate flowing through the bypass line 1332. Thus, the amount of the dialysate flowing through the dialysate extraction 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 filter pump 1333 is driven so as to send liquid in the water removal direction, a predetermined amount of water removal is performed from the blood in the blood purification unit 120 (see fig. 2).
The circulating blood amount measuring unit 140 is a sensor for measuring a hematocrit value of blood flowing through the blood circuit 110. For example, the hematocrit value can be measured based on the transmittance of blood obtained by irradiating 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 amount measuring unit 140 is disposed on the downstream side of the blood pump 11c and on the upstream side of the blood purification unit 120 in the artery side pipeline 111 so as to be less susceptible to the effects of the removal of water and the replenishment by the blood purification unit 120.
The control unit 150 is constituted by an information processing device (computer), and controls the operation of the dialysis apparatus 100 by executing a control program. Further, control unit 150 calculates the rate of change of the amount of circulating blood based on the hematocrit value measured by circulating blood amount measurement unit 140.
Specifically, the control unit 150 controls the operations of various pumps, clamps, and the like disposed in the blood circuit 110 and the dialysate circuit 130, and executes various processes performed by the dialysis apparatus 100, such as a priming process, a bleeding process, a dialysis process, a fluid replacement process, and a blood return process.
The 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 using the reverse osmosis dialysate as a priming solution.
In the apheresis step, blood of the patient is sucked and filled in the arterial line 111 and the venous line 112. After the blood removal step, a dialysis step (see fig. 2) is performed to purify blood and remove water. In the dialysis step, the excess water of the patient is removed, and water removal corresponding to the replacement fluid recovery is also performed.
The fluid replacement step is intermittently performed in the middle of the dialysis step (see fig. 3). After the dialysis step is completed, a blood returning step of returning blood to the patient is performed.
Hereinafter, among the various steps performed by the dialysis apparatus 100, the dialysis step and the fluid replacement step relating to a change in the amount of circulating blood will be described in detail.
The dialysis process will be described with reference to fig. 2.
In the dialysis step, the blood of the patient introduced from the artery-side connection portion 111a is purified in the blood purification unit 120 through the artery-side line 111, and returned to the patient from the vein-side connection portion 112a through the vein-side line 112.
In the dialysis step, as shown in fig. 2, the artery-side connection portion 111a and the vein-side connection portion 112a are connected to needles that puncture the blood vessels of the patient, the pre-flush discharge line holder 114a is in a clamped state, and the vein-side holder 112d is in an open state.
A dialysate supply device, not shown, supplies and discharges dialysate to and from the dialysate chamber 1331 at a liquid feed rate of 500 ml/min on average, and causes the water removal/reverse filtration pump 1333 to operate so as to feed the liquid in the water removal direction. As an example, the feed rate of the water removal/reverse filtration pump 1333 is set to 10 ml/min, so that water removal is performed at 10 ml/min in the blood purification unit 120.
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 artery-side connecting 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 200 ml/min, is removed at a flow rate of 10 ml/min, and is discharged from the blood outlet 122b at a flow rate of 190 ml/min. In addition, the dialysate is led out from the dialysate lead-out port 123 b.
In this way, water is gradually removed from the blood in the dialysis step, and the amount of circulating blood gradually decreases.
Next, the liquid replenishing step will be described with reference to fig. 3.
The fluid replacement step is a step of injecting the reverse-filtration dialysate into the blood circuit 110, and in the present 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 artery-side connection portion 111a and the vein-side connection portion 112a are connected to needles that puncture the blood vessel of the patient, respectively, as in the dialysis step, the pre-flush discharge line holder 114a is in a clamped state, and the vein-side holder 112d is in an open state.
A dialysate supply device, not shown, supplies and discharges dialysate to and from the dialysate chamber 1331 at a liquid feed rate of 500 ml/min on average, and causes the water removal/reverse filtration pump 1333 to operate so as to feed the dialysate in the reverse filtration direction. For example, in the case of performing 200 ml fluid replacement, the feed amount of the water removal/reverse filtration pump 1333 is set to 150 ml/min as an example, and the blood purification unit 120 performs 150 ml/min fluid replacement for about 80 seconds.
The blood pump 111c gradually decreases the flow rate from 200 ml/min to about 50 ml/min in the dialysis step, and sends blood from the artery-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-filtration dialysate is replenished at a flow rate of 150 ml/min, and the 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 replenishment step.
Next, a specific fluid replacement control method according to the present embodiment will be described with reference to fig. 4 to 8.
First, effects obtained by intermittently performing liquid replenishment will be briefly described.
During dialysis treatment, as water removal progresses, water (plasma) in blood is gradually removed, and the amount of circulating blood gradually decreases. When the circulating blood volume decreases and the protein concentration in the blood increases, the water (plasma) gradually moves from the interstitium to the blood vessel (plasma refilling) due to the osmotic pressure difference between the inside and outside of the blood vessel (interstitium), and the circulating blood volume is restored and the blood pressure is maintained. However, when the blood pressure continues to decrease without the rate of plasma refilling following the rate of water removal or the decrease in circulating blood volume, a biological response occurs in which peripheral blood vessels are contracted by the action of autonomic nerves to maintain the blood pressure. If it does not work properly, the rate of plasma refilling is significantly lower than the rate of water removal, and the rate of decrease in circulating blood volume becomes greater, resulting in a sharp drop in blood pressure.
To prevent such a rapid blood pressure drop, fluid replacement is intermittently performed. By performing dialysis while restoring the blood circulation volume by performing fluid replacement, the peripheral circulation is improved while preventing a decrease in blood pressure, and the rate of plasma refilling is maintained. As a result, the rate of decrease in the amount of circulating blood after the end of dialysis can be reduced even at the same water removal rate (except for the amount of replacement fluid collection) as compared with the case where replacement fluid is not performed. The blood purification unit 120 removes water from the blood by the amount of increase in the amount of circulating blood due to the implementation of fluid replacement from the start to the end of dialysis. Therefore, the total amount of water removed is the sum of the remaining water (the amount of water removed corresponding to the body weight) of the patient and the amount corresponding to the fluid replacement recovery.
In order to sufficiently obtain the above-described effects obtained by performing fluid replacement, the present invention can perform fluid replacement with an appropriate injection amount and injection interval.
Next, a change in the amount of circulating blood when fluid replacement is performed under normal conditions will be described.
Fig. 4 is a graph showing the rate of change in the circulating blood volume when fluid replacement is performed under the conditions of a normal infusion volume of 200 ml and an infusion interval of 30 minutes. As shown in fig. 4, it was found that the amount of circulating blood increased by the fluid replacement performed every 30 minutes.
The rate of increase in the amount of circulating blood obtained by this fluid replacement is considered to depend on the amount of fluid replacement from the outside of the body and the amount of plasma migration into the blood vessel due to the refilling of plasma in the body. The rate of refilling with plasma varies depending on the patient and also varies during dialysis, and therefore the appropriate amount of the replenishment solution to be injected varies for each replenishment solution application. In the case of the present embodiment, since the blood purification unit 120 does not perform the water removal during the injection of the replenishment solution, the amount of decrease due to the water removal may be eliminated.
The inventors of the present invention have studied the injection amount of the adequate replacement fluid, and as a result, it is considered that the change rate (increase rate) of the circulating blood volume by 1 replacement fluid execution is preferably in the range of 5 to 10%. If the rate of change exceeds 10%, the increase in the amount of circulating blood becomes rapid, which may cause a rapid increase in blood pressure. In addition, since the burden of the increase in blood pressure is increased in the case of a patient suffering from a heart disease, the upper limit of the rate of change may be set to a value lower than 10%, and the number of injections may be adjusted to be increased by decreasing the amount of the refill liquid injected per time. If the infusion amount of the replacement fluid is excessive, the water removal amount corresponding to the recovery of the replacement fluid increases, and the total water removal amount increases in addition to the remaining water of the patient. As a result, the water removal rate increases, and the risk of blood pressure drop increases. If the rate of change is less than 5%, the above-described effect obtained by fluid replacement cannot be sufficiently obtained.
Therefore, a method of controlling the injection amount of the replenishment solution so that the rate of change in the circulating blood amount by the replenishment solution is in the range of 5 to 10% will be described.
(1 st replenishment liquid control method)
In the present embodiment, a case where a total of 7 times of fluid replacement is performed in a treatment period of 4 hours with a constant injection interval of the replacement fluid set to 30 minutes will be described as an example with reference to fig. 5 and 6.
The control unit 150 measures the hematocrit value by the circulating blood amount measurement unit 140, and calculates the rate of change of the circulating blood amount over time based on the measured hematocrit value.
For example, the 1 st refill may be determined based on the patient's basal body weight. For example, the amount of the supplement solution to be injected may be determined such that the amount of the supplement solution to be injected is 200 ml for a patient with a basic weight of 50 kg or more, and 150 ml for a patient with less than 50 kg.
The flow of the dialysis treatment will be described with reference to fig. 5.
The dialysis apparatus 100 removes water at a predetermined speed after dialysis starts (S100). After a predetermined time has elapsed (S110), fluid replacement is performed by a predetermined injection amount (S120).
It is determined whether or not the latest fluid replacement is the last fluid replacement (S130), and if not, the next fluid replacement condition is set based on the rate of change (rate of increase) in the latest circulating blood volume (S140). In the case of the final fluid replacement, water removal is performed 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 that is set based on the amount of water to be removed from the patient by the dialysis treatment (water removal amount). The predetermined dialysis time in S160 is also referred to as the water removal time at the start of the dialysis treatment.
A method for setting the fluid replacement condition will be described with reference to fig. 6.
The rate of change in the amount of circulating blood before the start of infusion of the replacement fluid and after the end of infusion by the most recent execution of replacement fluid is calculated (S141), and it is determined whether or not the rate of change due to replacement fluid is within a predetermined range (S142). When the rate of change due to fluid replacement is within the range of 5 to 10%, it is determined that the injection amount of the replenishment fluid is an appropriate amount, and fluid replacement 30 minutes after the next time is performed at the same injection amount as the 1 st time (S143). When the rate of change due to fluid replacement exceeds 10%, it is determined that the injection amount is excessive, and the injection amount of fluid replacement 30 minutes after the next injection is decreased (S144). Specifically, the larger the rate of change of the circulating blood volume, the smaller the amount of fluid replacement to be injected may be, and the smaller the amount of 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 fluid replacement to be subtracted is calculated by calculating a ratio of the actual rate of change to the upper limit 10% of the rate of change of the amount of circulating blood, and multiplying the calculated ratio by 200 ml of the initial fluid replacement amount. In the above example, when the rate of change in the amount of circulating blood due to fluid replacement exceeds the predetermined range, both the infusion amount and the infusion interval of fluid replacement are controlled to be changed, but one may be not changed and only the other may be changed.
When the rate of change due to fluid replacement is less than 5%, it is determined that the injection amount is too small, and the injection amount of fluid replacement 30 minutes after the next injection is increased (S145). Specifically, the smaller the rate of change in the amount of circulating blood, the more the amount of fluid replacement to be injected may be increased, and the amount of fluid replacement to be injected may be increased at a certain rate regardless of the rate of change in the amount of circulating blood. For example, the amount of fluid infusion to be increased is calculated by calculating a ratio of the actual rate of change to the upper limit 10% of the rate of change of the amount of circulating blood, and multiplying the calculated ratio by 200 ml of the initial amount of fluid infusion.
In this way, the control unit 150 adjusts the injection amount of the refill next time based on the change rate of the circulating blood amount due to the latest refill so that the change rate of the circulating blood amount due to the next refill is in the range of 5 to 10%.
The amount of circulating blood volume increased by the substitution fluid may be recovered by adjusting the water removal rate from the start to the end of dialysis, and in the present embodiment, the amount injected in the latest substitution fluid is recovered by adding the remaining water (the amount of water removed according to the body weight) of the patient until the next substitution fluid as shown in fig. 7.
In addition, as for the recovery method of the amount increased by the replenishment liquid, as shown in fig. 8, the replenishment liquid may not be recovered after the last replenishment liquid is performed, but the recovery corresponding to the final replenishment liquid may be performed earlier before the last replenishment liquid is performed. In this case, regardless of the rate of change in the amount of circulating blood due to the latest fluid replacement, the amount of infusion of the last fluid replacement may be set to a predetermined amount, and the water removal may be performed earlier. Note that, for the sake of simplicity of explanation, the infusion amount of the replacement fluid is shown to be constant, but in reality, the infusion amount of the replacement fluid other than the infusion amount of the final replacement fluid fluctuates based on the rate of change in the amount of circulating blood due to the latest replacement fluid.
The dialysis apparatus 100 and the 1 st fluid replacement control method according to embodiment 1 described above provide the following effects.
(1) The dialysis apparatus 100 includes: a blood circuit 110; a blood purification unit 120; a dialysate circuit 130; a circulating blood amount measuring unit 140; a supplementary liquid injection unit for injecting a supplementary liquid into the blood circuit 110; and a control part 150 whichAccording toThe replenishment solution injection means is controlled so as to intermittently inject a predetermined amount of replenishment solution into the blood circuit 110 at predetermined intervals, and the control unit 150 controls the rate of water removal by the blood purification means 120 so as to recover at least water corresponding to the total amount of the replenishment solution injected into the blood circuit 110 during the period from the start to the end of dialysis by adjusting the injection amount of the next replenishment solution and the injection interval so that the change rate of the circulating blood amount due to the next replenishment solution injection falls within a predetermined range, based on the change rate of the circulating blood amount due to the latest replenishment solution injection measured by the circulating blood amount measurement means 140.
This enables the realization of adequate fluid replacement in accordance with the circulatory dynamics of the patient's blood, and therefore, the rapid increase in blood pressure due to fluid replacement can be suppressed, and the decrease in blood pressure due to water removal can be suppressed. Therefore, the blood pressure fluctuation during dialysis can be reduced, and dialysis treatment that reduces the burden on the patient can be performed. Further, by adjusting the injection amount of the replacement fluid so as not to be excessive, the water removal rate according to the replacement fluid recovery can be reduced, and the occurrence of a decrease in blood pressure due to an excessive water removal rate can be suppressed.
(2) The fluid replacement control method using the dialysis apparatus 100 is such that the rate of change of the amount of circulating blood produced by the latest refill injection is calculated using the rate of change measured by the circulating blood amount measuring means 140, the amount of next refill injection is set to be equal to the latest amount of refill injection if the rate of change of the amount of circulating blood produced by the latest refill injection is within a predetermined range, the amount of next refill injection is set to be smaller than the latest amount of refill injection based on the rate of change if the rate of change is larger than the predetermined range, and the amount of next refill injection is set to be larger than the latest amount of refill injection based on the rate of change if the rate of change is smaller than the predetermined range.
Accordingly, when the amount of infusion of the latest fluid replacement is appropriate, fluid replacement is performed similarly for the next time, when the amount of infusion of the latest fluid replacement is too large, the amount of infusion of the latest fluid replacement is reduced, and when the amount of infusion of the latest fluid replacement is too small, the amount of fluid replacement of the latest fluid replacement is increased, thereby realizing appropriate fluid replacement according to the blood circulation dynamics of the patient.
< embodiment 2 >
Next, a 2 nd fluid replacement control method using the dialysis apparatus 100 described in embodiment 1 will be described with reference to fig. 9 and 10. This embodiment is different from the 1 st fluid replacement control method in that the injection interval of the fluid replacement is not constant.
(No. 2 fluid infusion control method)
In the present embodiment, the infusion interval of the replacement fluid to be used as a reference is set to 30 minutes as an example, and the interval between the 2 nd and subsequent infusions is adjusted based on the rate of change in the amount of circulating blood generated by the latest replacement fluid.
The flow of the dialysis treatment is the same as that described in embodiment 1, and therefore, the description thereof is omitted, and a method of setting the fluid replacement condition is described with reference to fig. 9.
As shown in fig. 9, the rate of change in the amount of circulating blood before the start of infusion of the replacement fluid and after the end of infusion performed by the latest replacement fluid infusion is calculated (S141), and it is determined whether or not the rate of change due to replacement fluid is within a predetermined range (S142). When the rate of change due to fluid replacement is within the range of 5% to 10%, it is determined that the amount of refill fluid injected is an appropriate amount, the next fluid replacement is performed at the same injection amount as in the 1 st time, and the injection interval until the next fluid replacement is performed is set to a reference injection interval (30 minutes) (S146). When the rate of change due to fluid replacement exceeds 10%, it is determined that the injection amount is excessive, and the next fluid replacement injection amount is reduced and the injection interval until the next fluid replacement is longer than the reference injection interval (30 minutes) (S147). Specifically, the infusion interval may be set longer as the rate of change in the amount of circulating blood increases, or the infusion interval may be set longer by a certain ratio regardless of the rate of change in the amount of circulating blood. For example, the increasing time of the infusion interval is calculated by calculating a ratio of the actual rate of change to the upper limit 10% of the rate of change of the circulating blood volume and multiplying the calculated ratio by the reference infusion interval of 30 minutes.
When the rate of change due to fluid replacement is less than 5%, it is determined that the injection amount is too small, the injection amount of the next fluid replacement is increased, and the injection interval until the next fluid replacement is shorter than the reference injection interval (30 minutes) (S148). Specifically, the infusion interval may be made shorter as the rate of change in the circulating blood volume is smaller, or the infusion interval may be made shorter by a certain ratio regardless of the rate of change in the circulating blood volume. For example, the reduction time of the infusion interval is calculated by calculating a ratio of the actual rate of change to the upper limit 10% of the rate of change of the circulating blood volume, and multiplying the calculated ratio by the reference infusion interval of 30 minutes.
In this way, the control unit 150 adjusts the infusion amount of the next replacement fluid and adjusts the infusion interval until the next replacement fluid, based on the change rate of the amount of circulating blood due to the latest replacement fluid, so that the change rate of the amount of circulating blood due to the next replacement fluid is in the range of 5% to 10%.
As shown in fig. 10, the amount of infusion of the final replacement fluid may be adjusted by increasing or decreasing the dialysis remaining time after the final replacement fluid.
The amount of circulating blood increased by the substitution fluid may be recovered by adjusting the water removal rate from the start to the end of dialysis, and in the present embodiment, the amount of infusion in the nearest substitution fluid is recovered before the next substitution fluid (see fig. 10), as in the case described in embodiment 1.
According to the 2 nd fluid replacement control method of embodiment 2 described above, the following effects are obtained in addition to the above effects (1) and (2).
(3) The fluid replacement control method using the dialysis apparatus 100 is such that if the rate of change of the amount of circulating blood resulting from the latest fluid replacement infusion falls within the predetermined range, the interval until the next fluid replacement infusion is set to a predetermined infusion interval, if the rate of change is greater than the predetermined range, the interval until the next fluid replacement infusion is set to be longer than the predetermined infusion interval based on the rate of change, and if the rate of change is smaller than the predetermined range, the interval until the next fluid replacement infusion is set to be shorter than the predetermined infusion interval based on the rate of change, and the water removal rate of the blood purification unit 120 is controlled so that water corresponding to the infusion amount of the latest fluid is recovered during the period from the latest fluid replacement infusion to the next fluid replacement infusion.
Thus, when the amount of infusion of the latest replacement fluid is excessive, the infusion interval until the next replacement fluid is lengthened, whereby the water removal rate corresponding to the recovery of the replacement fluid can be reduced, and the occurrence of a drop in blood pressure due to an excessive water removal rate can be suppressed.
While the 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 embodiments and can be modified as appropriate.
For example, although the above-described embodiment has been described with respect to the case where the dialysate subjected to the reverse filtration is used as the replenishment liquid, the replenishment liquid may be physiological saline or a dialysate line directly connected to the blood circuit without passing through the blood purification unit may be used.
Description of the reference numerals
100 dialysis device
110 blood circuit
111 arterial side pipeline
111c blood pump
112 vein side line
120 blood purification unit
130 dialysate circuit
140 circulating blood volume measuring unit
150 control part
Claims (6)
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 solution injection means for injecting a replenishment solution for restoring the amount of circulating blood reduced by the 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 solution so that the change rate of the amount of the circulating blood due to the next replenishment solution injection falls within a predetermined range, based on the change rate of the amount of the circulating blood due to the latest replenishment solution injection measured by the measurement unit, and controls the water removal rate of the blood purification unit so that at least the water corresponding to the entire amount of the replenishment solution injected into the blood circuit is recovered during a period from the start to the end of dialysis.
2. The dialysis device of claim 1,
the blood purification unit and the dialysate circuit are used as the replenishment liquid injection unit, and dialysate reverse-filtered by the blood purification unit is used as the replenishment liquid.
3. A fluid replacement control method using a dialysis apparatus, the dialysis apparatus 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 for introducing and discharging dialysate;
a measurement unit that measures a rate of change in the amount of circulating blood;
a replenishment solution injection unit for injecting a replenishment solution for restoring the amount of circulating blood 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,
as for the fluid replacement control method, as described above,
calculating a change rate of the amount of circulating blood caused by the latest refill solution injection based on the change rate measured by the measuring means,
adjusting the injection amount and/or injection interval of the next replenishment solution so that the rate of change in the amount of circulating blood due to the injection of the next replenishment solution falls within a predetermined range based on the rate of change,
the speed of water removal by the blood purification unit is controlled so as to recover at least water corresponding to the entire amount of the replenishment liquid injected into the blood circuit from the start to the end of dialysis.
4. The fluid replacement control method according to claim 3,
if the rate of change of the amount of circulating blood resulting from the latest refill injection is within the predetermined range, the amount of refill injected next is equal to the latest amount,
if the change rate is larger than the predetermined range, the injection amount of the replenishment liquid is set to be smaller than the latest injection amount in accordance with the change rate,
if the change rate is smaller than the predetermined range, the injection amount of the replenishment liquid is set to be larger than the latest injection amount in accordance with the change rate.
5. The fluid replacement control method according to claim 3,
if the rate of change of the amount of circulating blood resulting from the most recent refill injection is within the predetermined range, the interval until the next refill injection is set to a predetermined injection interval,
if the change rate is larger than the predetermined range, the interval until the next refill liquid injection is longer than the predetermined injection interval according to the change rate,
if the change rate is smaller than the predetermined value, the interval until the next refill liquid injection is shorter than the predetermined injection interval according to the change rate,
the water removal rate of the blood purification unit is controlled so as to recover water corresponding to the amount of the replenishment liquid injected recently from the time of the most recent replenishment liquid injection to the time of the next replenishment liquid injection.
6. The fluid replacement control method according to any one of claims 3 to 5,
the predetermined range is 5% to 10%.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
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| JP2018121783A JP7183584B2 (en) | 2018-06-27 | 2018-06-27 | dialysis machine |
| JP2018-121783 | 2018-06-27 | ||
| PCT/JP2019/025756 WO2020004602A1 (en) | 2018-06-27 | 2019-06-27 | Dialysis device, and fluid replacement control method |
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| CN112312941A true CN112312941A (en) | 2021-02-02 |
| CN112312941B CN112312941B (en) | 2023-09-08 |
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| WO2022036739A1 (en) * | 2020-08-19 | 2022-02-24 | 上海心光生物医药有限责任公司 | Fluid treatment method, and cycle treatment device and system |
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| CN1711114A (en) * | 2002-11-14 | 2005-12-21 | 日机装株式会社 | Blood purification device |
| JP2007268257A (en) * | 2006-03-10 | 2007-10-18 | Asahi Kasei Medical Co Ltd | Hemodialysis unit |
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- 2018-06-27 JP JP2018121783A patent/JP7183584B2/en active Active
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2019
- 2019-06-27 CN CN201980042057.9A patent/CN112312941B/en active Active
- 2019-06-27 WO PCT/JP2019/025756 patent/WO2020004602A1/en active Application Filing
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| CN1711114A (en) * | 2002-11-14 | 2005-12-21 | 日机装株式会社 | Blood purification device |
| JP2005253768A (en) * | 2004-03-12 | 2005-09-22 | Nipro Corp | Dialyzing device |
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| CN112312941B (en) | 2023-09-08 |
| JP2020000415A (en) | 2020-01-09 |
| WO2020004602A1 (en) | 2020-01-02 |
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