JP2021049060A - Blood purification device - Google Patents

Abstract

To provide a blood purification device capable of measuring blood recirculation easily at low cost.SOLUTION: A blood purification device 100 includes: a blood purifier 120; an artery side line 111; a vein side line 112; replacement fluid injection means for injecting replacement fluid to the artery side line 111 or the vein side line 112; artery side measuring means 111M provided to the artery side line 111 for measuring a blood state; and a control unit 140 for controlling the replacement fluid injection means and the artery side measuring means 111M. The control unit 140 measures blood recirculation on the basis of a change in the blood state measured by the artery side measuring means 111M in a state in which the replacement fluid is injected by the replacement fluid injection means.SELECTED DRAWING: Figure 3

Description

The present invention relates to a blood purification device capable of measuring blood recirculation.

Hemodialysis therapy requires the patient's arteries and arteries to be punctured with indwelling needles to provide extracorporeal circulation of blood. In patients with chronic renal failure, puncturing every hemodialysis treatment three times a week is a heavy burden for both the patient and the medical staff, and the risk of medical accidents is high.
Therefore, conventionally, an inner shunt, an outer shunt, an arterial superficialization, an inner shunt using an artificial blood vessel, a double lumen catheter, or the like has been used as an entrance / exit for blood of a patient. Among them, the inner shunt is excellent from the viewpoint of long-term patency, hygiene, ease of management, etc., and is now the mainstream. The internal shunt obtains the blood flow required for dialysis treatment by allowing blood with good arterial flow to flow directly into the vein by bypass anastomosis between the artery of the upper arm and a part of the vein.

However, since the blood flow by this vascular anastomosis is different from the normal blood vessel flow, a puncture in long-term dialysis treatment becomes a burden and a lump is formed in the inner shunt, and a sufficient blood flow cannot be secured. The blood returned to the venous side may be bleeded from the arterial side as it is and flow to the blood purifier. Such a state is called blood recirculation, and when the blood recirculation rate, which is the ratio of this blood recirculation, increases, some blood is purified and removed by a blood purifier many times to concentrate, while Blood that is left in the body and is not sent to the blood purifier will not be sufficiently purified and removed, and it will not be possible to obtain a sufficient therapeutic effect.
Therefore, it is recommended to measure venous and arterial blood flow and, if possible, blood recirculation. For example, in Patent Document 1, a physiological saline injection line is connected to a venous side line, physiological saline is injected at a predetermined rate, and blood recirculation is performed based on a change in the concentration of blood flowing through the arterial side line. How to measure is described.

Japanese Patent No. 3627042

In the method described in Patent Document 1 described above, it is necessary to connect a saline infusion line in order to measure blood recirculation. In addition, the operation related to the measurement is complicated, such as the need for a medical worker to inject a predetermined amount of physiological saline, and it is actually necessary to measure the blood recirculation of each patient for each dialysis. Have difficulty.

Therefore, an object of the present invention is to provide a blood purification device capable of easily measuring blood recirculation.

The present invention includes a blood purifier, an arterial line that sends blood to the blood purifier, a venous line that returns the blood purified by the blood purifier to the patient, and the blood purifier, the arterial line, or the arterial line. A supplementary fluid injection means for injecting supplementary fluid into the venous side line, an arterial side measuring means provided in the arterial side line for measuring the state of blood flowing through the arterial side line, the supplementary fluid injection means, and the arterial side measurement. A control unit for controlling the means is provided, and the control unit replenishes blood based on a change in the blood state measured by the arterial side measuring means in a state where the replacement fluid is injected by the replacement fluid injection means. Regarding a blood purification device that measures circulation.

Further, it is preferable that the control unit intermittently injects the replacement fluid by the replacement fluid injection means a plurality of times.

Further, the blood purification device is provided on the venous side line and further includes a venous side measuring means for measuring the state of blood flowing through the venous side line, and the control unit is measured by the arterial side measuring means. It is preferable to measure the blood recirculation by comparing the change in the blood condition with the change in the blood condition measured by the venous side measuring means.

Further, the blood purifier has a blood side flow path and a dialysate side flow path, and the blood purification device is a dialysate introduction line for introducing dialysate into the dialysate side flow path, and the dialysate side flow. The supplementary solution injection means further provided with a dialysate circuit having a dialysate lead-out line for drawing out the dialysate from the path and a dialysate feeding section for sending the dialysate to the dialysate side flow path via the dialysate introduction line. Is preferably injected as a replacement solution into the venous line via the dialysate circuit and the blood purifier.

Further, the blood purifier has a blood side flow path and a dialysate side flow path, and the blood purification device is a dialysate introduction line for introducing dialysate into the dialysate side flow path, and the dialysate side flow. A dialysate circuit having a dialysate lead-out line for drawing out dialysate from a path, a dialysate feed section for sending dialysate to the dialysate side flow path via the dialysate introduction line, and the dialysate introduction line or A replacement solution line connecting the dialysate lead-out line and the arterial side line or the venous side line, and a replacement solution pump for sending dialysate to the arterial side line or the venous side line via the replacement solution line. It is preferable that the replacement solution injection means injects dialysate as a replacement solution into the arterial side line or the venous side line via the replacement solution line.

According to the present invention, it is possible to provide a blood purification device capable of easily measuring blood recirculation.

It is a figure which shows the schematic structure of the blood purification apparatus which concerns on 1st Embodiment of this invention. It is a block diagram of the blood purification apparatus which concerns on 1st Embodiment. It is a figure which shows the dialysis process in 1st Embodiment. It is a figure which shows the fluid replacement process in 1st Embodiment. The change in blood condition in the arterial line after fluid replacement is shown. It shows the change in blood condition in the venous line after fluid replacement injection. It is a block diagram of the hemodialysis apparatus which concerns on 2nd Embodiment of this invention. It is a figure which shows the dialysis process in 2nd Embodiment. It is a figure which shows the fluid replacement process in 2nd Embodiment. It is a figure which shows the dialysis process in 2nd Embodiment. It is a figure which shows the fluid replacement process in 2nd Embodiment.

Hereinafter, preferred embodiments of the blood purification apparatus of the present invention will be described with reference to the drawings.
The blood purification device of the present invention purifies the blood of a renal failure patient or a drug addict patient, and has a dialysis step of removing excess water in the blood, and replenishing (replenishing) water in the blood to circulate the patient. It is configured to be able to perform fluid replacement steps that increase blood volume. In addition, the blood purification device of the present invention continuously and automatically performs each step such as a priming step, a blood removal step, a replenishment step, and a blood return step by controlling the flow of dialysate to be injected into the blood circuit. It is an automatic blood purification device to be performed.

<First Embodiment>
The first embodiment will be described in detail with reference to FIGS. 1 to 6.
FIG. 1 is a diagram showing a schematic configuration of a blood purification device 100 according to the first embodiment of the present invention, and FIG. 2 is a block diagram of the blood purification device 100.

As shown in FIG. 1, the blood purification device 100 includes a blood circuit 110, a blood purifier 120, an arterial side measuring means 111M, a venous side measuring means 112M, a dialysate circuit 130, and a control unit 140. Be prepared.

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

One end of the arterial line 111 is connected to the blood inlet 122a of the blood purifier 120, which will be described later. An arterial side connection portion 111a, an arterial side bubble detector 111b, and a blood pump 111c are arranged on the arterial side line 111.
The arterial side connecting portion 111a is arranged on the other end side of the arterial side line 111. A needle punctured into a patient's blood vessel is connected to the arterial connection portion 111a.
The arterial bubble detector 111b detects the presence or absence of bubbles in the tube.
The blood pump 111c is arranged downstream of the arterial bubble detector 111b in the arterial line 111. The blood pump 111c delivers a liquid such as blood or priming fluid inside the arterial line 111 by squeezing the tube constituting the arterial line 111 with a roller.

One end of the venous line 112 is connected to the blood outlet 122b of the blood purifier 120, which will be described later. The venous side connection 112a, the venous air bubble detector 112b, the drip chamber 112c, and the venous side clamp 112d are arranged on the venous side line 112.
The venous side connecting portion 112a is arranged on the other end side of the venous side line 112. A needle that punctures the patient's blood vessel is connected to the venous side connection portion 112a.
The vein side bubble detector 112b detects the presence or absence of bubbles in the tube.
The drip chamber 112c is arranged on the upstream side of the vein side bubble detector 112b. The drip chamber 112c stores a certain amount of blood or air in order to remove air bubbles and coagulated blood mixed in the vein side line 112 and to measure the venous pressure.
The venous side clamp 112d is arranged on the downstream side of the venous side bubble detector 112b. The venous side clamp 112d is controlled according to the detection result of air bubbles by the venous side air bubble detector 112b, and opens and closes the flow path of the venous side line 112.

The drug line 113 supplies the arterial line 111 with the drug required during hemodialysis. One end of the drug line 113 is connected to the drug solution pump 113a for delivering the drug, and the other end is connected to the arterial line 111. Further, the drug line 113 is provided with a clamping means (not shown), and the flow path is closed by the clamping means except when the drug is injected. In the first embodiment, the other end side of the drug line 113 is connected to the downstream side of the blood pump 111c in the arterial side line 111.

The drainage line 114 is connected to the drip chamber 112c. A drainage line clamp 114a is arranged on the drainage line 114. The drainage line 114 is a line for draining the priming liquid in the priming step of cleaning and cleaning the blood circuit 110 and the blood purifier 120.

The blood purifier 120 includes a container body 121 formed in a tubular shape and a dialysis membrane (not shown) housed inside the container body 121, and the inside of the container body 121 is made of blood by the dialysis membrane. It is divided into a side flow path and a dialysate side flow path (neither is 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.

The arterial side measuring means 111M is a sensor for measuring the state of blood taken out from the patient, and is provided on the arterial side line 111. In the first embodiment, the arterial side measuring means 111M is arranged in the vicinity of the blood introduction port 122a of the blood purifier 120 in the arterial side line 111.

The venous side measuring means 112M is a sensor for measuring the state of blood returned to the patient, and is provided on the venous side line 112. In the first embodiment, the venous measuring means 112M is arranged between the blood purifier 120 and the drip chamber 112c in the venous line 112. The venous measuring means 112M is not essential for measuring blood recirculation, but the arterial line 111 and the arterial line 111 and the arterial line 111 and the arterial line 111 are compared with the case where the blood recirculation is measured based only on the change in the blood condition of the arterial line 111. By measuring and comparing changes in the blood state of both of the venous side lines 112, the measurement accuracy of blood recirculation can be improved.

Specific examples of the blood state measured by the arterial side measuring means 111M and the venous side measuring means 112M include a hematocrit value, a hemoglobin value, and an electrical resistivity that change according to the blood concentration. In the first embodiment, the hematocrit value is measured as an index indicating the state of blood.

According to the above blood circuit 110 and blood purifier 120, the blood taken out from the artery of the subject (dialysis patient) flows through the arterial side line 111 by the blood pump 111c and flows through the blood side flow path of the blood purifier 120. Introduced in. The blood introduced into the blood purifier 120 is purified by the dialysate flowing through the dialysate circuit 130 described later via the dialysate membrane. The blood purified in the blood purifier 120 passes through the venous side line 112 and is returned to the subject's vein.

In the first embodiment, the dialysate circuit 130 is composed of a so-called closed capacity control type dialysate circuit 130. The dialysate circuit 130 includes a dialysate supply line 131a, a dialysate drainage line 131b, a dialysate introduction line 132a, a dialysate lead-out line 132b, and a dialysate delivery unit 133.

The dialysate delivery unit 133 includes a dialysate chamber 1331, a bypass line 1332, and a water removal / reverse filtration pump 1333.
The dialysate chamber 1331 is composed of a hard container capable of accommodating a constant volume (for example, 300 mL to 500 mL) of dialysate, and the inside of the container is formed by a soft diaphragm (diaphragm) to provide a liquid feed accommodating portion 1331a and drainage. It is partitioned into a housing portion 1331b.
The bypass line 1332 connects the dialysate lead-out line 132b and the dialysate drainage line 131b.

The water removal / backfiltration pump 1333 is located at bypass line 1332. The water removal / reverse filtration pump 1333 has a direction in which the dialysate inside the bypass line 1332 is circulated to the dialysate drainage line 131b side (water removal direction) and a direction in which the dialysate is circulated to the dialysate discharge line 132b side (back filtration direction). It consists of a pump that is driven so that the liquid can be sent to the dialysis.

The dialysate supply line 131a is connected to the dialysate supply device (not shown) at the proximal end side and to the dialysate chamber 1331 at the distal end side. The dialysate supply line 131a supplies the dialysate to the liquid supply accommodating portion 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 purifier 120, and dialysates the dialysate contained in the liquid supply accommodating portion 1331a of the dialysate chamber 1331 to the blood purifier 120. Introduce into the liquid side flow path.

The dialysate outlet line 132b connects the dialysate outlet 123b of the blood purifier 120 and the dialysate chamber 1331, and discharges the dialysate discharged from the dialysate side flow path of the blood purifier 120 to the dialysate chamber 1331. It is led out to the liquid accommodating portion 1331b.

The base end side of the dialysate drainage line 131b is connected to the dialysate chamber 1331, and drainage of the dialysate contained in the drainage storage unit 1331b is discharged.

According to the above dialysate circuit 130, by partitioning the inside of the hard container constituting the dialysate chamber 1331 with a soft diaphragm (diaphragm), the amount of dialysate derived from the dialysate chamber 1331 (condensation of the dialysate). The amount of dialysate supplied to section 1331a) and the amount of drainage collected in the dialysate chamber 1331 (drainage accommodating section 1331b) can be made equal.
As a result, when the water removal / reverse filtration pump 1333 is stopped, the flow rate of the dialysate introduced into the blood purifier 120 and the amount of dialysate (drainage) drawn out from the blood purifier 120 are the same. Can be done. Further, when the water removal / reverse filtration pump 1333 is driven so as to send the liquid in the water removal direction, the blood purifier 120 removes a predetermined amount of water from the blood at a predetermined speed. Further, when the water removal / back filtration pump 1333 is driven so as to send the liquid in the back filtration direction, a predetermined amount of dialysate is injected (back filtration) into the blood circuit 110 in the blood purifier 120.

The control unit 140 is composed of an information processing device (computer), and controls the operation of the blood purification device 100 by executing a control program.
Specifically, as shown in FIG. 2, the control unit 140 controls the operations of various pumps, clamps, and the like arranged in the blood circuit 110 and the dialysate circuit 130, and is performed by the blood purification device 100. Steps such as priming step, blood removal step, dialysis step, replenishment step, blood return step and the like are executed.

Among the various steps described above, the dialysis step and the fluid replacement step related to the present invention will be briefly described with reference to FIGS. 3 and 4.

In the dialysis process, the patient's excess water is removed and waste products are removed.
In the dialysis step, the patient's blood introduced from the arterial connection 111a is purified by the blood purifier 120 through the arterial line 111 and returned to the patient from the venous connection 112a through the venous line 112. ..

In the dialysis step, as shown in FIG. 3, the arterial side connection portion 111a and the venous side connection portion 112a are in a state of being connected to a needle punctured in the blood vessel of the patient, respectively, and the drainage line clamp 114a is in a closed state. The venous side clamp 112d is in the open state.

The dialysate supply device (not shown) supplies and discharges dialysate to the dialysate chamber 1331 at an average flow rate of 500 mL / min, and uses the water removal / back filtration pump 1333 as an example in the water removal direction. Operate to deliver liquid at 10 mL. As a result, 10 mL / min of water is removed in the blood purifier 120.
The blood pump 111c delivers blood from the arterial side connection portion 111a side to the blood purifier 120 side at a flow rate of, for example, 200 mL / min.
Blood flows into the blood purifier 120 at a flow rate of 200 mL / min from the blood inlet 122a, is drained at a flow rate of 10 mL / min, and is drawn out from the blood outlet 122b at a flow rate of 190 mL / min. Further, the dialysate drainage is led out from the dialysate outlet 123b.
In this way, water is removed at a flow rate of 10 mL / min in the dialysis step.

Next, the fluid replacement step will be described with reference to FIG.
The replenishment process is performed to increase the circulating blood volume of the patient, and is performed as necessary when symptoms such as blood pressure decrease or physical tension occur during the dialysis process, as well as prevention of blood pressure decrease. For the purpose of improving peripheral circulation, it can be systematically performed multiple times at regular intervals during the dialysis process. In the first embodiment, the blood purifier 120, the dialysate introduction line 132a, the dialysate lead-out line 132b, and the dialysate delivery unit 133 are used as the replacement fluid injection means, and the fluid is injected into the venous side line 112 via the blood purifier 120. The reverse filtration dialysate can be used as a replacement fluid.
In the first embodiment, the case where the replacement fluid is injected into the venous side line 112 via the blood purifier 120 has been described, but depending on the configuration of the blood circuit 110, the replacement fluid is directly injected into the arterial side line 111. It may be (see the second embodiment).

In the fluid replenishment step, as shown in FIG. 4, the arterial side connection portion 111a and the venous side connection portion 112a are each connected to the needle punctured in the patient's blood vessel, and the drainage line clamp 114a is in the same state as in the dialysis step. Is in the closed state, and the vein side clamp 112d is in the open state.

The dialysate supply device (not shown) supplies and discharges dialysate to the dialysate chamber 1331 at an average feed rate of, for example, 500 mL / min, and causes the water removal / backfiltration pump 1333 to reverse filtration (FIG. 4). The liquid is sent to the bypass line 1332 in the direction indicated by the arrow). For example, when 200 mL of fluid replacement is performed, 200 mL of water is injected in the blood purifier 120 in about 120 seconds by setting the back filtration rate of the water removal / back filtration pump 1333 to 100 mL / min as an example.
The blood pump 111c reduces the flow rate from 200 mL / min to about 50 mL / min during the dialysis process, and discharges blood from the arterial side connection portion 111a side to the blood purifier 120 side.
Blood flows into the blood purifier 120 at a flow rate of 50 mL / min from the blood inlet 122a, reverse filtration dialysate is injected at a flow rate of 100 mL / min, and 150 mL of diluted blood is injected from the blood outlet 122b. Derived at a flow rate of / min. In this way, the fluid is rapidly replenished with water in about 120 seconds in the fluid replacement step, increasing the circulating blood volume of the patient.

As described above, the circulating blood volume of the patient increases by the amount of the replacement fluid injected by the replacement fluid step. Therefore, in order to remove water to the patient's target body weight in the dialysis process, it is necessary to extend the time of the dialysis process when the water removal rate is constant. Further, by adding the water removal rate so as to remove the water increased by the replacement fluid, it is possible to remove water to the target body weight without extending the time of the dialysis process.

Next, a specific method for measuring blood recirculation in the first embodiment will be described with reference to FIGS. 5 and 6.

(Measuring method)
In the blood purification device 100 of the present invention, a predetermined amount of replacement fluid (reverse filtration dialysate) is injected into the venous side line 112 by using the replacement fluid injection means to dilute the blood returned to the patient, and the arterial side measuring means 111M is used. Blood recirculation is measured based on changes in the measured blood condition (hematcrit value). Here, the replacement fluid may be injected only for measuring the blood recirculation, but in this case, as described above, the increase in the circulating blood volume of the patient increases the time of the dialysis step and the water removal rate. Need to increase. It is necessary to be careful because the extension of the dialysis process time is a burden on the patient, and the rapid increase in the water removal rate causes a decrease in blood pressure and an overconcentration of blood.

Therefore, in the first embodiment, the blood recirculation is measured at the same time when the above-mentioned planned fluid replacement step is performed. As a result, the amount of replenished liquid is removed within the time of the dialysis process, which causes an extension of the time of the dialysis process, which is a burden on the patient, overconcentration of blood, and a rapid increase in the water removal rate, which causes a decrease in blood pressure. Blood recirculation can be measured without any need. In particular, when a predetermined amount (200 mL) of replacement fluid is systematically injected every predetermined time (30 minutes) in the replacement fluid step, the blood recirculation is measured at the same time to change the blood recirculation over time. Can be observed. Therefore, for example, if the recirculation rate increases during the dialysis treatment (that is, if the recirculation rate increases in the second and subsequent fluid replacement steps of the multiple fluid replacement steps), the position of puncture, shunt failure, etc. It can be inferred that this is not the cause, but the change in body position between the fluid replacement steps.
Further, in the conventional measurement of blood recirculation, for example, physiological saline is rapidly injected into the 10 mL venous line, and the amount of dilution is small. However, in the present invention, together with the fluid replacement step. When measuring blood recirculation, the measurement accuracy can be improved because the amount of dilution is larger than in the past, for example, by injecting 200 mL of replacement fluid at 100 mL / min.

A specific method for measuring blood recirculation will be described. If the recirculation rate of blood is low, that is, most of the diluted blood returned to the patient from the venous connection 112a flows forward through the vein and there is little regurgitation, then the blood flowing through the arterial line 111 is hardly diluted. The change in blood condition (hematocrit value) measured by the arterial side measuring means 111M is as shown in FIG. 5 (a). In FIG. 5A, the vertical axis represents the hematocrit value and the horizontal axis represents time. The same applies to FIGS. 5 (b) and 6.
On the other hand, when the blood recirculation rate is high, that is, when most of the diluted blood returned to the patient from the venous connection 112a flows back, the blood flowing through the arterial line 111 is diluted and the arterial measuring means 111M The change in the blood condition (hematocrit value) measured by the above is shown in FIG. 5 (b).

Further, by further providing the venous side measuring means 112M in the venous side line 112 and measuring the change in the state of the diluted blood returned to the patient, the change in the state of the diluted blood measured in the venous side line 112 By comparing this with the change in blood condition measured on the arterial side line 111, the measurement accuracy of blood recirculation can be improved.
Specifically, the change in the blood state (hematocrit value) measured by the venous side measuring means 112M when the replacement fluid is injected is as shown in FIG. The blood recirculation rate can be accurately measured by comparing the reduced area of the hematocrit value shown in FIGS. 5 (a) and 5 (b) with the reduced area of the hematocrit value shown in FIG. 6 as a reference.

According to the blood purification device 100 of the first embodiment described above, the following effects are obtained.

(1) The blood purifying device 100 includes a blood purifying device 120, an arterial side line 111, a venous side line 112, a replacement fluid injection means, an arterial side measuring means 111M for measuring the state of blood, a control unit 140, and the like. The blood recirculation was measured by the control unit 140 based on the change in the blood condition measured by the arterial side measuring means 111M in the state where the replacement fluid was injected by the replacement fluid injection means. As a result, it is possible to perform replacement fluid for blood recirculation measurement using the configuration for performing the replacement fluid step, so that a separate replacement fluid injection line may be provided or a liquid such as physiological saline may be injected. Blood recirculation can be measured without. Therefore, blood recirculation can be easily measured. Further, it is not necessary to increase the amount of water to be removed as compared with the case where the replacement fluid is injected only for the blood recirculation measurement separately from the replacement fluid step. Therefore, it is not necessary to extend the dialysis time or increase the water removal rate. Moreover, since the blood can be sufficiently diluted by the fluid replacement step, the recirculation can be measured accurately.

(2) The control unit 140 was allowed to intermittently inject the replacement fluid (replenishment step) by the replacement fluid injection means a plurality of times. This makes it possible to measure changes in blood recirculation over time. For example, if recirculation increases during dialysis treatment, it is not due to the position of puncture or shunt failure, but due to changes in body position. I can guess.

(3) The blood purification device 100 is provided on the venous side line 112 and further includes the venous side measuring means 112M for measuring the state of blood returned to the patient, and the control unit 140 is provided with the arterial side measuring means 111M. Blood recirculation was measured by comparing the measured change in blood condition with the change in blood condition measured by the venous side measuring means 112M. As a result, the measurement accuracy of blood recirculation can be improved as compared with the case where only the arterial side is measured.

(4) The blood purifier 120 is configured to include the blood side flow path and the dialysate side flow path, and the blood purification device 100 is a dialysate introduction line 132a for introducing the dialysate into the dialysate flow path, and the dialysate. A dialysate circuit having a dialysate delivery unit 133 that sends dialysate to the dialysate side flow path via a dialysate lead-out line 132b, a dialysate introduction line 132a, and a dialysate lead-out line 132b that lead out dialysate from the side flow path. It was configured to include 130. Then, the replacement fluid injection means was made to inject the dialysate as a replacement fluid into the venous side line 112 via the dialysate circuit 130 and the blood purifier 120. As a result, since the reverse filtration dialysate can be used as a replacement fluid, it is possible to suppress an increase in cost for measuring blood recirculation as compared with the case of using a conventional physiological saline solution.

<Second Embodiment>
Next, the blood purification device according to the second embodiment will be described with reference to FIGS. 7 to 11. The blood purification device of the second embodiment has a different circuit configuration from that of the first embodiment, and the blood purification device is a replacement for directly injecting a dialysate as a replacement fluid (replacement fluid) into the blood circuit 110. It is configured to include a liquid line.
FIG. 7 is a block diagram showing the configurations of blood purification devices 100A and 100B according to the second embodiment of the present invention. Online hemodiafiltration by pre-dilution (hereinafter referred to as pre-dilution online HDF) will be described with reference to FIGS. 8 and 9, and online HDF by post-dilution will be described with reference to FIGS. 10 and 11. Those having the same configuration as that described in the first embodiment are designated by the same reference numerals and the description thereof will be omitted.

Here, HDF is a low- and medium-molecular-weight protein that is difficult to pass through the dialysis membrane in hemodialysis by injecting a replacement solution in order to increase the amount of replacement solution to be filtered in the blood purifier 120 and performing filtration in a larger amount than in hemodialysis. It is one of the dialysis treatments that can remove more of the blood. The pre-dilution type is for injecting the replacement solution on the upstream side of the blood purifier 120, and the post-dilution type is for injecting on the downstream side. Online HDF is a method of injecting a replacement solution from a dialysate circuit using a dialysate as a replacement solution, and offline HDF is a method of injecting a replacement solution using a replacement solution bag or the like. In the second embodiment, the blood purification devices 100A and 100B capable of performing online HDF will be described as an example, but blood purification devices capable of performing offline HDF are also included in the scope of the present invention.

First, online HDF by pre-dilution will be described.
The blood purification device 100A shown in FIG. 8 can carry out a dialysis step by online HDF by pre-dilution, and includes a blood circuit 110, a blood purifier 120, an arterial side measuring means 111M, a venous side measuring means 112M, and dialysis. It includes a liquid circuit 130, a control unit 140, a replacement liquid line 150A, and a replacement liquid pump 151.

The replacement liquid line 150A is a line for directly injecting the dialysate in the dialysate circuit 130 into the blood circuit 110, and is mainly composed of a flexible and soft tube through which the liquid can flow. As shown in FIG. 8, the upstream side of the replacement solution line 150A is connected to the dialysate introduction line 132a of the dialysate circuit 130. A replacement liquid line clamp 152 is arranged on the downstream side of the replacement liquid line 150A, and is connected to the downstream side of the blood pump 111c of the arterial side line 111.
The replacement liquid line clamp 152 is controlled by the control unit 140 to open and close the flow path of the replacement liquid line 150A.

The replacement liquid pump 151 is arranged in the replacement liquid line 150A, takes out the dialysate from the dialysate circuit 130, and sends the dialysate to the blood circuit 110 (arterial side line 111).

The arterial side measuring means 111M is a sensor for measuring the state of blood taken out from the patient, and is provided on the arterial side line 111. In the case of the pre-dilution method of the second embodiment, the arterial side measuring means 111M may be arranged at a position in the arterial side line 111 that is not affected by the inflow of the replacement liquid from the replacement liquid line 150A. In the present embodiment, the arterial side measuring means 111M is arranged on the upstream side of the connection portion with the replacement liquid line 150A.

The venous side measuring means 112M is a sensor for measuring the state of blood returned to the patient, and is provided on the venous side line 112. In the pre-dilution method of the second embodiment, the venous measuring means 112M is arranged between the blood purifier 120 and the drip chamber 112c in the venous line 112. The venous measuring means 112M is not essential for measuring blood recirculation, but the arterial line 111 and the arterial line 111 and the arterial line 111 and the arterial line 111 are compared with the case where the blood recirculation is measured based only on the change in the blood condition of the arterial line 111. By measuring and comparing changes in the blood state of both of the venous side lines 112, the measurement accuracy of blood recirculation can be improved.

Next, the dialysis step and the fluid replacement step in the pre-dilution online HDF using the blood purification device 100A will be briefly described with reference to FIGS. 8 and 9.

In the dialysis step, the blood purifier 120 removes excess water and the replacement solution of the patient and removes waste products.
In the dialysis step, the patient's blood introduced from the arterial connection 111a is purified by the blood purifier 120 together with the replacement solution through the arterial line 111, and from the venous connection 112a through the venous line 112. Returned to.

In the dialysis step, as shown in FIG. 8, the arterial side connection portion 111a and the venous side connection portion 112a are in a state of being connected to a needle punctured in the blood vessel of the patient, respectively, and the drainage line clamp 114a is in a closed state. The venous side clamp 112d is in the open state, and the replacement liquid line clamp 152 is in the open state.

The dialysate supply device (not shown) supplies and discharges dialysate to the dialysate chamber 1331 at an average flow rate of 500 mL / min, and uses the water removal / back filtration pump 1333 as an example in the water removal direction. Operate to deliver liquid at 10 mL. The dialysate is injected into the arterial line 111 at 300 mL / min by the replacement pump 151, and 310 mL / min of water is removed in the blood purifier 120.
The blood pump 111c delivers blood from the arterial side connection portion 111a side to the blood purifier 120 side at a flow rate of, for example, 200 mL / min.
Blood and a replacement solution (dialysate) flow into the blood purifier 120 at a flow rate of 500 mL / min from the blood inlet 122a, are drained at a flow rate of 310 mL / min, and 190 mL / min from the blood outlet 122b. Derived at the flow rate of. Further, the dialysate drainage is led out from the dialysate outlet 123b.
In this way, water is removed at a flow rate of 10 mL / min in the dialysis step.

Next, the fluid replacement step will be described with reference to FIG.
In the pre-dilution method in the second embodiment, a blood purifier 120, a dialysate introduction line 132a, a dialysate lead-out line 132b, a dialysate delivery unit 133, a replacement fluid line 150A, and a replacement fluid pump 151 are used as replacement fluid injection means. An online dialysate injected into the arterial line 111 via the replacement fluid line 150A can be used as the replacement fluid.

In the fluid replenishment step, as shown in FIG. 9, the arterial side connection portion 111a and the venous side connection portion 112a are respectively connected to the needle punctured in the patient's blood vessel, and the drainage line clamp 114a is in the same state as in the dialysis step. Is in the closed state, and the venous side clamp 112d and the replacement liquid line clamp 152 are in the open state.

The dialysate supply device (not shown) supplies and discharges dialysate to the dialysate chamber 1331 at an average feed rate of, for example, 500 mL / min, and causes the water removal / backfiltration pump 1333 to reverse filtration (FIG. 9). The liquid is sent to the bypass line 1332 in the direction indicated by the arrow). For example, when 200 mL of fluid replacement was performed, the back filtration rate of the water removal / back filtration pump 1333 was set to 100 mL / min as an example. When the flow rate of the replacement liquid pump 151 is set to 300 mL / min as in the dialysis step, the amount of water removed by the blood purifier 120 is reduced from 310 mL / min in the dialysis step to 200 mL / min. Substantially 200 ml of water is injected from the replacement liquid line 150A in about 120 seconds. The reverse filtration dialysate may be injected at a flow rate of 100 mL / min in the blood purifier 120 with the flow rate of the replacement liquid pump 151 being 0 mL / min. That is, either the online dialysate via the replacement fluid line 150A and the back-filtered dialysate via the blood purifier 120 may be used so that a substantially predetermined amount of replacement fluid can be injected.

The blood pump 111c reduces the flow rate from 200 mL / min to about 50 mL / min during the dialysis process, and discharges blood from the arterial side connection portion 111a side to the blood purifier 120 side.
Blood, replacement fluid and replacement fluid flow into the blood purifier 120 at a flow rate of 350 mL / min from the blood inlet 122a, and water is removed at a flow rate of 200 mL / min, and diluted blood is discharged from the blood outlet 122b. Derived at a flow rate of 150 mL / min. In this way, the fluid is rapidly replenished with water in about 120 seconds in the fluid replacement step, increasing the circulating blood volume of the patient.

Next, online HDF by post-dilution will be described.
The blood purification device 100B shown in FIG. 10 can carry out a dialysis step by online HDF by post-dilution, and includes a blood circuit 110, a blood purifier 120, an arterial side measuring means 111M, a venous side measuring means 112M, and dialysis. It includes a liquid circuit 130, a control unit 140, a replacement liquid line 150B, and a replacement liquid pump 151.

The replacement liquid line 150B is a line for directly injecting the dialysate in the dialysate circuit 130 into the blood circuit 110, and is mainly composed of a flexible and soft tube through which the liquid can flow. As shown in FIG. 10, the upstream side of the replacement solution line 150B is connected to the dialysate introduction line 132a of the dialysate circuit 130. A replacement liquid line clamp 152 is arranged on the downstream side of the replacement liquid line 150B, and is connected to a drip chamber 112c arranged on the venous side line 112.
The replacement liquid line clamp 152 is controlled by the control unit 140 to open and close the flow path of the replacement liquid line 150B.

The replacement liquid pump 151 is arranged in the replacement liquid line 150B, takes out the dialysate from the dialysate circuit 130, and sends the dialysate to the blood circuit 110 (venous side line 112).

The arterial side measuring means 111M is a sensor for measuring the state of blood taken out from the patient, and is provided on the arterial side line 111. In the post-dilution method of the second embodiment, the arterial side measuring means 111M is arranged in the vicinity of the blood inlet 122a of the blood purifier 120 in the arterial side line 111.

The venous side measuring means 112M is a sensor for measuring the state of blood returned to the patient, and is provided on the venous side line 112. In the post-dilution method of the second embodiment, the venous side measuring means 112M is connected to the replacement liquid line 150B of the venous side lines 112 in order to measure the state of blood after the replacement fluid and the replacement fluid are injected. It is arranged on the downstream side of the drip chamber 112c. The venous measuring means 112M is not essential for measuring blood recirculation, but the arterial line 111 and the arterial line 111 and the arterial line 111 and the arterial line 111 are compared with the case where the blood recirculation is measured based only on the change in the blood condition of the arterial line 111. By measuring and comparing changes in the blood state of both of the venous side lines 112, the measurement accuracy of blood recirculation can be improved.

Next, the dialysis step and the fluid replacement step in the post-dilution online HDF using the blood purification device 100B will be briefly described with reference to FIGS. 10 and 11.

In the dialysis step, the blood purifier 120 removes excess water and waste products from the patient. In the post-dilution method, the amount of filtration is increased in the blood purifier 120, and the excess filtered portion is replenished with a replacement solution.
In the dialysis step, the patient's blood introduced from the arterial connection 111a is purified by the blood purifier 120 through the arterial line 111 and returned to the patient from the venous connection 112a through the venous line 112. ..

In the dialysis step, as shown in FIG. 10, the arterial side connection portion 111a and the venous side connection portion 112a are in a state of being connected to a needle punctured in the blood vessel of the patient, respectively, and the drainage line clamp 114a is in a closed state. The venous side clamp 112d is in the open state, and the replacement liquid line clamp 152 is in the open state.

The dialysate supply device (not shown) supplies and discharges dialysate to the dialysate chamber 1331 at an average flow rate of 500 mL / min, and uses the water removal / back filtration pump 1333 as an example in the water removal direction. Operate to deliver liquid at 10 mL / min. The dialysate is injected into the venous line 112 (drip chamber 112c) at 50 mL / min by the replacement pump 151, and 60 mL / min of water is removed in the blood purifier 120.
The blood pump 111c delivers blood from the arterial side connection portion 111a side to the blood purifier 120 side at a flow rate of, for example, 200 mL / min.
Blood flows into the blood purifier 120 at a flow rate of 200 mL / min from the blood inlet 122a, is drained at a flow rate of 60 mL / min, and is drawn out from the blood outlet 122b at a flow rate of 140 mL / min. At the venous line 112, the replacement solution (dialysate) flows in at a flow rate of 50 mL / min and blood is returned to the patient at a flow rate of 190 mL / min. Further, the dialysate drainage is led out from the dialysate outlet 123b.
In this way, water is removed at a flow rate of 10 mL / min in the dialysis step.

Next, the fluid replacement step will be described with reference to FIG.
The replacement fluid step is performed for the same purpose as that described in the first embodiment, and in the second embodiment, the blood purifier 120, the dialysate introduction line 132a, the dialysate lead-out line 132b, and the dialysate feed as the replacement fluid injection means. The liquid portion 133, the replacement fluid line 150B, and the replacement fluid pump 151 can be used.

In the fluid replenishment step, as shown in FIG. 11, the arterial side connection portion 111a and the venous side connection portion 112a are each connected to the needle punctured in the patient's blood vessel, and the drainage line clamp 114a is in the same state as in the dialysis step. Is in the closed state, and the venous side clamp 112d and the replacement liquid line clamp 152 are in the open state.

The dialysate supply device (not shown) supplies and discharges dialysate to the dialysate chamber 1331 at an average feed rate of, for example, 500 mL / min, and causes the water removal / backfiltration pump 1333 to reverse filtration (FIG. 11). The liquid is sent to the bypass line 1332 in the direction indicated by the arrow). For example, when 200 mL of fluid replacement was performed, the back filtration rate of the water removal / back filtration pump 1333 was set to 100 mL / min as an example. When the flow rate of the replacement liquid pump 151 is 50 mL / min as in the dialysis step, the back filtration dialysate is injected at a flow rate of 50 mL / min in the blood purifier 120. In this way, substantially 200 ml of water is injected via the blood purifier 120 and the replacement liquid line 150B in about 120 seconds. The reverse filtration dialysate may be injected at a flow rate of 100 mL / min in the blood purifier 120 with the flow rate of the replacement liquid pump 151 being 0 mL / min. That is, either the online dialysate via the replacement fluid line 150B and the back-filtered dialysate via the blood purifier 120 may be used so that a substantially predetermined amount of replacement fluid can be injected.
The blood pump 111c reduces the flow rate from 200 mL / min to about 50 mL / min during the dialysis process, and discharges blood from the arterial side connection portion 111a side to the blood purifier 120 side.
Blood flows into the blood purifier 120 at a flow rate of 50 mL / min from the blood inlet 122a, a reverse filtration dialysate is injected at a flow rate of 100 mL / min, and 150 mL of diluted blood is injected from the blood outlet 122b. Derived at a flow rate of / min. In this way, the fluid is rapidly replenished with water in about 120 seconds in the fluid replacement step, increasing the circulating blood volume of the patient.

The method for measuring blood recirculation in the second embodiment is the same as that in the first embodiment, and thus the description thereof will be omitted.

According to the blood purification devices 100A and 100B of the second embodiment described above, in addition to the above-mentioned effects (1) to (5), the following effects are obtained.

(6) The blood purification apparatus 100A (100B) is connected to the replacement solution line 150A (150B) and the replacement solution line 150A that connect the dialysate introduction line 132a or the dialysate lead-out line 132b to the arterial side line 111 or the venous side line 112. A replacement solution pump 151 for sending dialysate as a replacement solution to the arterial side line 111 or the venous side line 112 via (150B) is included, and the replacement solution injection means is provided with the arterial side line 111 via the replacement solution line. Alternatively, dialysate was injected into the venous line 112 as a replacement solution. As a result, since the online dialysate can be used as the replacement fluid, it is possible to suppress an increase in the cost for measuring blood recirculation as compared with the case where a conventional physiological saline solution is used.

Although the preferred embodiments of the blood purification apparatus of the present invention have been described above, the present invention is not limited to the above-described embodiments and can be appropriately modified.

For example, in each of the above-described embodiments, the replacement fluid step is performed and the blood recirculation is measured. However, separately from the replacement fluid step, the replacement fluid is injected by the replacement fluid injection means to dilute the blood and the blood recirculation is measured. You may.

Further, in the second embodiment, the flow rate of the replacement liquid pump was set to the same flow rate as in the case of the dialysis step when injecting the replacement liquid, but the flow rate of the replacement liquid pump was appropriately adjusted, and the back filtration dialysate and the online dialysate were appropriately adjusted. A predetermined amount of supplementary solution may be injected using both or one of the above.

Further, in the second embodiment, the case where the online dialysate is used as the replacement fluid used in the replacement fluid step is shown, but the present invention is not limited to this. For example, in the case of post-diluted HDF, a saline solution line may be connected and a saline solution may be used as a replacement fluid, and when measuring blood recirculation, both the physiological saline solution and the reverse filtration dialysate may be used as the replacement fluid. Either one may be used.

Further, in the first embodiment, the replacement fluid is injected by back filtration in the replacement fluid step, but the present invention is not limited to this. That is, the blood purification device may be configured to include a replacement liquid line and a replacement liquid pump as shown in the second embodiment. Then, in this case, in the dialysis step, the replacement liquid pump is stopped and the water removal / back filtration pump is operated in the water removal direction to remove water at a predetermined flow rate (that is, HDF is not performed), and in the liquid replenishment step. Replenishment may be performed via the replacement liquid line by operating the replacement liquid pump and operating the water removal / reverse filtration pump in the reverse filtration direction (for example, the same operation as shown in FIG. 9). ..

100, 100A, 100B Dialysis machine 110 Blood circuit 111 Arterial side line 111c Blood pump 112 Vein side line 120 Blood purifier 130 Dialysate circuit 133 Dialysate delivery unit 140 Control unit 150A, 150B Replacement fluid line 151 Replacement fluid pump

Claims (5)

With a blood purifier,
The arterial line that sends blood to the blood purifier,
The venous line that returns the blood purified by the blood purifier to the patient,
A fluid replacement injecting means for injecting fluid into the blood purifier, the arterial line or the venous line, and the like.
An arterial side measuring means provided on the arterial side line and measuring the state of blood flowing through the arterial side line,
A control unit for controlling the replacement fluid injection means and the arterial side measuring means is provided.
The control unit is a blood purification device that measures blood recirculation based on a change in the blood state measured by the arterial side measuring means in a state where the replacement fluid is injected by the replacement fluid injection means. The blood purification device according to claim 1, wherein the control unit intermittently injects the replacement fluid by the replacement fluid injection means a plurality of times. Further provided with a venous side measuring means provided in the venous side line and measuring the state of blood flowing through the venous side line.
The control unit measures blood recirculation by comparing a change in blood condition measured by the arterial side measuring means with a change in blood condition measured by the venous side measuring means. The blood purification device described in. The blood purifier has a blood-side flow path and a dialysate-side flow path.
The blood purification device is
A dialysate introduction line for introducing dialysate into the dialysate side flow path, a dialysate lead-out line for leading out dialysate from the dialysate side flow path, and a dialysate side flow path via the dialysate introduction line. Further provided with a dialysate circuit having a dialysate feed section for delivering dialysate,
The blood purification apparatus according to any one of claims 1 to 3, wherein the replacement fluid injection means injects a dialysate as a replacement fluid into the vein side line via the dialysate circuit and the blood purifier. The blood purifier has a blood-side flow path and a dialysate-side flow path.
The blood purification device is
A dialysate introduction line for introducing dialysate into the dialysate side flow path, a dialysate lead-out line for leading out dialysate from the dialysate side flow path, and a dialysate side flow path via the dialysate introduction line. A dialysate circuit having a dialysate feed section that feeds dialysate,
A replacement solution line connecting the dialysate introduction line or the dialysate lead-out line with the arterial side line or the venous side line.
A replacement fluid pump that sends dialysate to the arterial side line or the venous side line via the replacement fluid line is further provided.
The blood purification apparatus according to any one of claims 1 to 4, wherein the replacement fluid injection means injects a dialysate as a replacement fluid into the arterial side line or the venous side line via the replacement fluid line.

Images