WO2021059573A1 - Blood purification device - Google Patents

Abstract

Provided is a blood purification device with which a filtration flow rate can be increased even if a blood removal flow rate is low in a single needle method. A blood purification device 100 which operates by a single needle method comprises: a blood purifier 120; a blood circuit 110; a substitution liquid supply source 152; a substitution liquid line 150; and a control unit 140. The control unit 140 repeatedly executes a treatment process comprising: a blood removal step in which blood is introduced to the blood circuit 100; a removed blood circulation step in which the blood introduced in the blood removal step and blood introduced at a second flow rate are circulated in the blood circuit 110; and a blood return step in which a substitution liquid is injected into the blood circuit 110 and blood is led out from the blood circuit 110. The removed blood circulation step is performed in: a water removal step in which water removal is carried out at the same flow rate as the second flow rate; or in a filtration step in which a dialysis liquid is injected into the blood circuit 110 at a third flow rate and water removal is carried out in the blood purifier 120 at a flow rate obtained by adding the third flow rate to the second flow rate.

Description

Blood purification device

The present invention relates to a blood purification device that alternately performs blood removal and blood return with a single puncture needle.

As one of the blood purification therapies, blood purification such as hemodialysis by the so-called single needle method in which blood removal and blood return are alternately performed with one puncture needle is known. Since the single needle method requires only one puncture, the patient's pain and the burden on the medical staff are less than the case of two punctures, and even if a needle removal accident occurs, the amount of blood loss can be reduced. There are advantages.
However, in the generally performed single needle method, blood removal and blood return are alternately performed, so that the blood flow circulating in the blood circuit is small, and particularly for the removal of substances having a relatively large molecular weight such as low molecular weight proteins. , It was difficult to obtain sufficient dialysis efficiency (removal efficiency). Therefore, it is difficult to be the first choice for treatment at present, and it is difficult to puncture two normal indwelling needles because, for example, vascular access is underdeveloped in elderly patients and patients in the early stage of dialysis introduction. The single-needle method is indicated for patients who do not require dialysis efficiency (removal efficiency) due to low activity. In addition, since the frequency of dialysis is high in home dialysis patients who can perform dialysis at any time according to their physical condition, the single needle method is useful, but it is necessary to perform dialysis for a long time in order to improve dialysis efficiency (removal efficiency). is there.

Therefore, in order to increase the dialysis efficiency (removal efficiency), Patent Document 1 proposes that hemodialysis filtration is performed with a single puncture.
Specifically, a circulation step is performed between a blood removal step in which blood is introduced into a part of the blood circuit by filtration and a blood return step in which dialysate is injected into a part of the blood circuit by back filtration to return blood. By doing so, the blood flow is secured. In addition, after the blood removal process that introduces blood into the entire blood circuit by filtration, the total blood volume that passes through the blood purifier is secured by circulating the blood at a blood flow volume higher than the filtration (water removal) speed. Is.

Japanese Patent No. 4352775

In the single needle method, blood removal and blood return cannot be performed at the same time, so a large flow rate of blood removal cannot be performed continuously. Therefore, in the method described in Patent Document 1, it is possible to secure the blood flow rate by circulation, but there is a limit to the filtration flow rate depending on the de-blood flow rate. Therefore, it has been difficult to further increase the efficiency of removing solutes, which increases in proportion to the filtration flow rate.

Therefore, an object of the present invention is to provide a blood purification device capable of increasing the filtration flow rate even if the de-blood flow rate is small in the single needle method.

The present invention is a blood purification device that alternately performs blood removal and blood return with one puncture needle, and is a blood purifier, a blood circuit, a replacement liquid supply source, the blood circuit, and the replacement liquid supply source. The control unit includes a replacement liquid line and a control unit for connecting the blood to the blood circuit, and the control unit has a blood removal step of introducing blood into the blood circuit at a first flow rate, and a blood removal process that is more than the first flow rate. A blood removal circulation step of introducing blood at a small second flow rate and circulating the blood introduced in the blood removal step and the blood introduced at the second flow rate in the blood circuit, and a replacement liquid in the blood circuit. The blood removal step of injecting blood to draw blood from the blood circuit and the treatment step including the blood return step are repeated, and the blood removal and circulation step is performed by removing water at the same flow rate as the second flow rate in the blood purifier. The replacement solution is injected into the blood circuit at a third flow rate via the water step or the replacement solution line, and water is removed at the flow rate obtained by adding the third flow rate to the second flow rate in the blood purifier. The present invention relates to a blood purification device performed in any of the filtration steps.

Further, the blood purification device includes a dialysate circuit as the replacement liquid supply source, uses the dialysate as the replacement liquid, and the control unit performs the blood purification as the water removal step in the blood removal circulation step. In the vessel, water is removed at the same flow rate as the second flow rate and a dialysis step is performed, and as the filtration step, the replacement solution is injected into the blood circuit through the replacement solution line at a third flow rate. In the blood purifier, it is preferable to perform a dialysis filtration step of removing water at a flow rate obtained by adding the third flow rate to the second flow rate and dialysis at the same time.

Further, the blood purification device includes a dialysate circuit as the replacement liquid supply source, uses the dialysate as the replacement liquid, and the dialysate circuit is configured so as not to allow the dialysate to flow into the blood purifier. Is preferable.

Further, it is preferable to use a replacement liquid bottle or a replacement liquid bag filled with the replacement liquid as the replacement liquid supply source.

Further, as the replacement liquid supply source, a replacement liquid bottle or a replacement liquid bag filled with the replacement liquid is used, the blood purification device is provided with a dialysate circuit, and the control unit is used in the blood removal circulation step. As the water removal step, a dialysis step of removing water at the same flow rate as the second flow rate and dialysis is performed in the blood purifier, and as the filtration step, a replacement solution is applied to the blood circuit via the replacement solution line. It is preferable to perform a dialysis filtration step of injecting the blood at a third flow rate, removing water at the flow rate obtained by adding the third flow rate to the second flow rate in the blood purifier, and dialysis at the same time.

Further, in the blood removal step, the control unit removes water at the first flow rate in the blood purifier and introduces blood into the blood circuit from both the upstream side and the downstream side of the blood purifier. It is preferable to do so.

Further, it is preferable that the treatment step further includes a homogenization step of circulating and homogenizing the dialysate and blood of the blood circuit after the blood return step.

Further, in the homogenization step, it is preferable that the control unit introduces blood into the blood circuit at the second flow rate and removes water at the same flow rate as the second flow rate in the blood purifier. ..

Further, it is preferable that the control unit returns blood by inflowing dialysate into all of the blood circuits in the blood return step.

Further, it is preferable that the control unit injects a dialysate into the blood circuit via the replacement solution line to return blood in the blood return step.

Further, it is preferable that the control unit performs the dialysis step in the blood removal circulation step until the treatment step is repeated a predetermined number of times, and then performs the dialysis filtration step.

According to the blood purification apparatus of the present invention, in the blood removal circulation step, a filtration step of removing blood for the amount of blood removed and the amount of replacement liquid injected while removing blood with a small amount is performed to increase the filtration flow rate and remove solutes. Efficiency can be increased.

It is a figure which shows the schematic structure of the blood purification apparatus of this invention. It is a block diagram of the blood purification apparatus of this invention. It is a figure which shows the unilateral blood removal process in 1st Embodiment. It is a figure which shows another example of the one-sided blood removal step shown in FIG. It is a figure which shows the dialysis process of the blood removal circulation process in 1st Embodiment. It is a figure which shows the dialysis filtration process of the blood removal circulation process in 1st Embodiment. It is a figure which shows the unilateral blood return process in 1st Embodiment. It is a figure which shows the homogenization step in 1st Embodiment. It is a figure which shows another example of the homogenization step shown in FIG. It is a figure which shows the bilateral blood removal process in 2nd Embodiment. It is a figure which shows the bilateral blood return process in 2nd Embodiment. It is a figure which shows the schematic structure of the blood purification apparatus which concerns on 3rd Embodiment of this invention. It is a figure which shows the water removal process of the blood removal circulation process in 3rd Embodiment. It is a figure which shows the filtration process of the blood removal circulation process in 3rd Embodiment. It is a figure which shows the schematic structure of the blood purification apparatus which concerns on 4th Embodiment of this invention. It is a figure which shows the water removal process of the blood removal circulation process in 4th Embodiment. It is a figure which shows the filtration process of the blood removal circulation process in 4th Embodiment. It is a figure which shows the schematic structure of the blood purification apparatus which concerns on 5th Embodiment of this invention. It is a figure which shows the dialysis process of the blood removal circulation process in 5th Embodiment. It is a figure which shows the dialysis filtration process of the blood removal circulation process in 5th Embodiment.

Hereinafter, preferred embodiments of the blood purification apparatus of the present invention will be described with reference to the drawings.
The blood purification apparatus according to the first and second embodiments of the present invention can perform blood purification by the so-called single needle method in which blood is removed and returned with a single puncture needle, and a replacement solution is injected into the blood circuit. It is possible to carry out dialysis therapy without dialysis and online dialysis filtration therapy in which a replacement solution is injected into a blood circuit and blood is purified while filtering an amount equivalent to the replacement solution. Further, in the blood purification apparatus according to the first and second embodiments of the present invention, a flow of injecting a dialysate in a blood circuit in each step such as a blood removal step, a blood removal circulation step, a blood return step and a homogenization step. It is an automatic blood purification device that automatically performs continuously by controlling.
The first embodiment describes a blood purification device that repeatedly performs a treatment step including a blood removal step, a blood removal circulation step, a blood return step, and a homogenization step, and a second embodiment describes a blood removal step, a blood removal circulation step, and a return. A blood purification device that repeats a treatment process including a blood process will be described.

<First Embodiment>
The first embodiment will be described in detail with reference to FIGS. 1 to 9.

The blood purification device 100 shown in FIG. 1 includes a blood circuit 110, a blood purifier 120, a dialysate circuit 130, a control device 140 as a control unit, a replacement liquid line 150, a replacement liquid pump 151, and venous pressure. It includes a sensor PS.

The blood circuit 110 has an arterial side line 111, a venous side line 112, and a drainage line 113. The arterial side line 111, the venous side line 112, and the drainage line 113 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 connection portion 111a is arranged on the other end side of the arterial side line 111, and is a single puncture needle SN that is punctured into a patient's blood vessel via a Y-shaped or T-shaped bifurcation tube BP. Connected to.
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, and is connected to the above-mentioned puncture needle SN via the branch tube BP to which the above-mentioned arterial side connecting portion 111a is connected.
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 drainage line 113 is connected to the drip chamber 112c. A drainage line clamp 113a is arranged on the drainage line 113. The drainage line 113 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 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. Further, the dialysate circuit 130 is connected to the replacement liquid line 150, which will be described later, and is used as the replacement liquid supply source 152.

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 the accommodating portion 1331b.
The bypass line 1332 connects the dialysate lead-out line 132b and the dialysate drainage line 131b.

The water removal / reverse filtration pump 1333 is arranged on the 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 lead-out line 132b connects the dialysate outlet 123b of the blood purifier 120 and the dialysate chamber 1331, and leads the dialysate discharged from the blood purifier 120 to the drainage accommodating portion 1331b of the dialysate chamber 1331. To do.

The base end side of the dialysate drainage line 131b is connected to the dialysate chamber 1331, and the dialysate drainage contained in the drainage accommodating portion 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. 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 (filters) 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 device 140 is composed of an information processing device (computer), and controls the operation of the blood purification device 100 by executing a control program.
As shown in FIG. 2, specifically, the control device 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 a blood removal step, a blood removal circulation step, a blood return step, a homogenization step, and the like are performed.

The replacement liquid line 150 is a line for directly injecting the dialysate in the dialysate circuit 130 used as the replacement liquid supply source 152 into the blood circuit 110 as the replacement liquid, and is a flexible soft material through which the liquid can flow. It is mainly composed of the tube of. As shown in FIG. 1, the upstream side of the replacement solution line 150 is connected to the dialysate introduction line 132a of the dialysate circuit 130. The downstream side of the replacement solution line 150 is connected to the arterial side line 111 which is the upstream side of the blood purifier 120 in the case of the pre-dilution method, and the vein which is the downstream side of the blood purifier 120 in the case of the post-dilution method. It is connected to the side line 112.

The replacement liquid pump 151 is arranged in the replacement liquid line 150, takes out the dialysate as the replacement liquid from the dialysate circuit 130 (replacement liquid supply source 152), and takes out the dialysate as the replacement liquid to the blood circuit 110 (arterial side line 111 or venous side line 112). Send liquid to.

The venous pressure sensor PS is connected to the drip chamber 112c. The venous pressure sensor PS detects the venous pressure, which is the pressure inside the drip chamber 112c.

Next, the treatment process repeatedly performed using the blood purification device 100 will be described with reference to FIGS. 3 to 9. The treatment steps of the first embodiment include the blood removal step shown in FIGS. 3 and 4, the blood removal circulation step shown in FIGS. 5 and 6, the blood return step shown in FIG. 7, and the homogeneity shown in FIGS. 8 and 9. Including the chemical conversion process.

FIG. 3 shows a one-sided blood removal process. In the one-sided blood removal step, the water removal / reverse filtration pump 1333 is driven in the water removal direction and the blood pump 111c is driven in the forward rotation direction at a predetermined flow rate (for example, 40 ml / min) as the same first flow rate. Blood is introduced into the arterial side line 111 and the blood purifier 120 via one puncture needle SN. For example, when the internal volume (priming volume) of the arterial side line 111 and the blood purifier 120 is about 100 ml, the one-sided blood removal step takes about 2.5 minutes.
In the blood removal step of the present embodiment, the blood removal step is terminated when the blood reaches the blood purifier 120 without removing water from the removed blood, and the process proceeds to the next blood removal circulation step. The blood removal step in the first treatment step is performed after the priming step, and is performed in a state where the blood circuit 110 is filled with a dialysate as a priming solution. When the first blood removal step is completed, the vein side line 112 is filled with a dialysate as a priming solution.
In the present embodiment, an example in which the arterial side line 111 is used as an example of the unilateral blood removal step is shown, but the blood pump 111c may be stopped and blood removal may be performed using the venous side line 112.

Further, as shown in FIG. 4, as another example of the one-sided blood removal step, the blood pump 111c is rotated in the forward direction without driving the water removal / reverse filtration pump 1333 with the venous side clamp 112d closed. As the first flow rate, blood may be introduced into the arterial side line 111 and the blood purifier 120 via one puncture needle SN by driving at a predetermined flow rate (for example, 40 ml / min). When the venous pressure detected by the venous pressure sensor PS reaches a predetermined upper limit due to the blood introduced into the blood circuit 110, the blood pump 111c is stopped to end the blood removal step, and the process proceeds to the next blood removal circulation step.

FIG. 5 shows a dialysis step as a water removal step performed in the blood removal circulation step. In the dialysis step, the blood pump 111c is gradually increased in speed until it reaches a predetermined flow rate (for example, 200 ml / min) in the forward rotation direction, and the water removal / back filtration pump 1333 is used as a second flow rate. It is driven at a water removal rate (for example, 10 ml / min). Further, in the dialysate circuit 130, the dialysate is led out to the blood purifier 120 from the dialysate chamber 1331 (delivery solution accommodating portion 1331a) at a predetermined flow rate (for example, 400 ml / min). As a result, the dialysate was introduced into the blood purifier 120 through the dialysate introduction line 132a at a predetermined flow rate (for example, 400 ml / min), and a second flow rate was added to the dialysate lead-out line 132b at a predetermined flow rate. A dialysate containing water removed at a flow rate (eg 410 ml / mim) is derived.
That is, in the blood purifier 120, a small amount of blood is removed at the same flow rate (second flow rate) as the water removal rate while removing excess water and waste products of the patient, and the blood introduced in the blood removal step and The newly introduced blood is circulated in the blood circuit 110.
In the dialysis step, the replacement solution is not injected into the blood circuit 110, and the blood circulating in the blood circuit 110 is gradually concentrated while being dialyzed. As a result, small molecular weight substances such as urea are mainly removed. The dialysis step is performed, for example, by arranging a blood concentration sensor near the blood outlet 122b of the blood purifier 120 and monitoring the hematocrit value, and ends when the blood is concentrated until the hematocrit value reaches a predetermined value. .. Then, the process proceeds to the next blood return step.
Here, it is known that the viscosity of blood increases as the concentration increases, and the viscosity increases sharply especially when the hematocrit value exceeds 50%. Due to the increase in viscosity, the dialysis membrane of the blood purifier 120 is easily clogged, resulting in deterioration of the dialysis membrane. Therefore, it is preferable to concentrate the blood so that the hematocrit value does not exceed 50%.
Further, the dialysis step may be completed with the passage of a predetermined time or the arrival of a predetermined water removal amount (blood removal amount) as a guide.

FIG. 6 shows a dialysis filtration step as a filtration step performed in the blood removal circulation step. In the dialysis filtration step, the blood pump 111c is gradually increased in speed until it reaches a predetermined flow rate (for example, 200 ml / min) in the forward rotation direction, and the water removal / reverse filtration pump 1333 is driven at a predetermined water removal rate (for example, 200 ml / min). for example, it is driven at 10 ml / min), further driven at a predetermined replacement fluid rate _{Q R} of the substitution fluid pump 151 as a third flow rate. Further, in the dialysate circuit 130, a predetermined flow rate _{(e.g., 400 + Q R ml / min} ) the dialysate is derived from the dialysate chamber 1331 (liquid feed containing portion 1331a) to the blood purifier 120 in. As a result, the dialysate is introduced into the blood purifier 120 through the dialysate introduction line 132a at a predetermined flow rate (for example, 400 ml / min), and the dialysate lead-out line 132b has a second flow rate and a third flow rate at a predetermined flow rate. the dialysate including dewatering and moisture at a flow rate of the added flow (e.g. _{400 + 10 + Q R ml /} mim) is derived.

That is, in the diafiltration process, while injecting dialysate as substitution fluid to the blood circuit 110 at a predetermined flow rate Q _{R (third} flow rate), the water removal of the excess water removal and the patient's waste products in the blood purifier 120 at a flow rate plus substitution fluid injection amount _{Q R} (third flow rate) to the second flow rate is a rate (10 ml / min) performing water removal. Further, a small amount of blood is removed at the same flow rate as the water removal rate (second flow rate), and the blood introduced in the blood removal step and the newly introduced blood are circulated in the blood circuit 110.

Further, the circulation flow rate of the blood circuit 110 determined by the flow rate of the blood pump 111c can be arbitrarily set without depending on the blood removal flow rate (second flow rate). Therefore, even if the blood removal flow rate (second flow rate) is small, the circulation flow rate can be increased, and especially in the case of the post-dilution method, it is limited to about 1/4 of the blood flow rate (circulation flow rate) from the viewpoint of blood concentration. The filtration flow rate to be performed can be increased. Therefore, the efficiency of removing solutes can be further improved.
In the dialysis filtration step, a large amount of filtration is performed in the blood purifier 120 to mainly remove large molecular weight substances such as low molecular weight proteins. Further, as in the dialysis step, the blood circulating in the blood circuit 110 is gradually concentrated, the dialysis filtration step is completed based on the blood concentration, elapsed time, water removal amount (blood removal amount), etc., and the next return is performed. Move to the blood process.

FIG. 7 shows a one-sided blood return process. In the one-sided blood return step of the present embodiment, the blood pump 111c is stopped and the venous side clamp 112d is opened, and the water removal / reverse filtration pump 1333 is operated at a predetermined flow rate (for example, 60 ml / min) in the reverse filtration direction. The replacement liquid pump 151 is further driven at the same flow rate as the water removal / back filtration pump 1333. In this way, various pumps and clamps are controlled to inject dialysate (replacement solution) into the blood circuit 110 via the replacement solution line 150, and blood is discharged from the venous side line 112 via one puncture needle SN. Derived and returned blood to the patient. For example, when the internal volume (priming volume) of the vein side line 112 and the blood purifier 120 is about 100 ml, it takes about 1.7 minutes for the injected dialysate to reach the vicinity of the puncture needle SN. It takes. After the blood is returned, the process proceeds to the next homogenization step. The arterial line 111, which was not used for blood return, is filled with concentrated blood.
In the present embodiment, an example in which the venous side line 112 is used as an example of the unilateral blood return step is shown, but the blood pump 111c is driven in the reverse rotation direction at the same flow rate as the water removal / reverse filtration pump 1333 to drive the artery. Blood may be returned using the side line 111. Further, in the present embodiment, the case where the dialysate (replacement solution) is injected into the blood circuit 110 via the replacement solution line 150 to return blood is shown, but the reverse filtration dialysate is injected in the blood purifier 120. By doing so, blood may be returned.

FIG. 8 shows the homogenization step. The homogenization step is a blood circuit when concentrated blood remains in the blood circuit 110 after the blood return step and blood is removed in the blood removal step through the line where the blood remains. This is a step of circulating the dialysate (replacement solution) and blood in 110 to homogenize the concentration. By performing this homogenization step, the residual blood is prevented from being excessively concentrated in the blood removal step, and the amount of blood removal is secured. Further, by circulating the dialysate at a predetermined flow rate in the dialysate circuit 130, the dialysate flows into the blood purifier 120, and the small molecular weight substance is removed (dialysis) by diffusion.
In the present embodiment, the dialysate is circulated through the dialysate circuit 130 at 400 ml / min with the water removal / reverse filtration pump 1333 and the replacement liquid pump 151 stopped, and the blood pump 111c is used as an example to rotate forward at 200 ml / min. Driven in the direction, the remaining blood and dialysate are circulated and homogenized, and dialysis is performed.

Further, as shown in FIG. 9, the water removal / reverse filtration pump 1333 is driven in the water removal direction at a flow rate of 10 ml / min as an example to remove water from the patient's body fluid and remove a small amount of blood while homogenizing. You may. In this way, by continuing to remove water while performing a small amount of blood removal in the homogenization step following the blood removal circulation step, the time required to remove the predetermined amount of water to be removed from the patient's body fluid is increased. It can be shortened and the dialysis efficiency (removal efficiency) can be improved.

In this way, after performing the homogenization step for about several minutes, the process is completed and the process proceeds to the blood removal step of the next treatment step.

In the blood removal step in the second and subsequent treatment steps, the blood diluted with the dialysate remains.
For example, in the second and subsequent blood removal steps, when water is removed at 40 ml / min as described in FIG. 3, the diluted blood remaining in the arterial side line 111 is concentrated. If an attempt is made to filter all the diluted blood remaining on the arterial side line 111, the blood will be excessively concentrated, and the blood will coagulate and become clogged in the blood purifier 120. Therefore, a blood concentration sensor is provided on the line used for blood removal, and water is removed until a predetermined concentration (for example, 50% of the hematocrit value) is reached, and the amount corresponding to the amount of water removed is removed to form a blood circuit. The blood removal process is completed and the next blood removal circulation process is started.

By repeating the treatment process described above, water is removed and solutes are removed.

As described above, in the present embodiment, either the dialysis step as the water removal step or the dialysis filtration step as the filtration step is selected and carried out in the blood removal circulation step. The control method in the blood removal circulation step will be described below.
In dialysis filtration in which the filtration flow rate in the blood purifier 120 is large to filter the replacement solution injected into the blood circuit 110, the amount of albumin leaked becomes excessive at the initial stage of treatment, and the amount leaked is small after a certain period of time. It has been reported that Therefore, in the blood purification apparatus 100 of the present embodiment, the dialysis step as the water removal step is performed in the blood removal circulation step until the albumin leakage is reduced, that is, until the treatment step is repeated a predetermined number of times, and then the blood removal circulation is performed. It is preferable to perform a dialysis filtration step as a filtration step in the step. As a result, in the first half of blood purification therapy, the filtration flow rate is set to a small flow rate similar to the water removal rate for removing excess water from the patient, and the leakage of albumin is suppressed. In the latter half, the filtration flow rate is large and mainly large molecular weight substances can be removed. By controlling the blood removal and circulation process in this way, it is possible to reduce the amount of albumin leaked while improving the removal efficiency of both the small molecular weight substance and the large molecular weight substance.

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

(1) In a blood purification device 100 that alternately performs blood removal and blood return with one puncture needle SN, a blood removal step of introducing blood into a blood circuit 110 at a first flow rate in a control device 140 and a blood circuit. A blood removal circulation step in which blood is introduced into 110 at a second flow rate smaller than the first flow rate, and blood introduced in the blood removal step and blood introduced at the second flow rate are circulated in the blood circuit 110. A treatment step including a blood return step of injecting a replacement solution into the blood circuit 110 and deriving blood from the blood circuit is repeated, and the blood removal circulation step is removed by the blood purifier 120 at the same flow rate as the second flow rate. In the water removal step of watering, or the replacement liquid is injected into the blood circuit 110 through the replacement liquid line 150 at a third flow rate, and the blood purifier 120 adds the third flow rate to the second flow rate. One of the filtration steps for removing water was performed. As a result, in the filtration step performed in the blood removal circulation step, even if the flow rate of blood removal (second flow rate) is as small as the water removal rate for removing excess water of the patient, large filtration is performed. Filtering can be performed at a flow rate, and the removal efficiency of mainly large molecular weight substances (low molecular weight proteins) can be improved. Further, in the blood removal circulation step, the flow rate of blood removal (second flow rate) is as small as the water removal rate for removing excess water of the patient, so that the time of the blood removal circulation step should be lengthened. And the time required for the treatment process can be lengthened. Therefore, since the number of repetitions of the treatment step can be reduced, the time required for the blood removal step and the blood return step has a small influence on the time required for the dialysis treatment, so that the blood introduction flow rate (first flow rate) in the blood removal step is small. ) And the blood derivation flow rate (return blood flow rate) in the blood return step need not be increased. Therefore, the present invention can be applied to patients with low vascular access blood flow. Further, the circulation flow rate of the blood circuit 110 determined by the flow rate of the blood pump 111c can be arbitrarily set without depending on the blood removal flow rate (second flow rate). Therefore, even if the blood removal flow rate (second flow rate) is small, the circulation flow rate can be increased, and especially in the case of the post-dilution method, it is limited to about 1/4 of the blood flow rate (circulation flow rate) from the viewpoint of blood concentration. The filtration flow rate to be performed can be increased. Therefore, the efficiency of removing solutes can be further improved. In addition, since the dialysis efficiency is high, it can be applied to patients who have not been indicated for the treatment of the single needle method until now.

(2) The blood purification device 100 is configured to include a dialysate circuit 130 as a replacement liquid supply source 152, a dialysate is used as a replacement liquid, and a second blood purifier 120 is used as a water removal step in the control device 140. A dialysis step of removing water and performing dialysis is performed at the same flow rate as that of the blood purifier 120, and as a filtration step, the replacement solution is injected into the blood circuit 110 via the replacement solution line 150 at a third flow rate. In, water was removed at a flow rate obtained by adding a third flow rate to the second flow rate, and a dialysis filtration step of dialysis was performed. Thereby, the removal efficiency of both the small molecular weight substance and the large molecular weight substance can be improved.

(3) In the treatment step, in the blood return step, the replacement solution (dialysis solution) is made to flow into a part of the blood circuit 110 to return the blood, and the blood not returned to the line used for blood removal in the blood circuit 110. If the blood remains, the homogenization step of circulating and homogenizing the replacement solution (dialysis solution) of the blood circuit 110 and the blood after the blood return step is further included. As a result, it is possible to prevent overconcentration of residual blood in the blood removal step and secure the amount of blood removal newly introduced into the blood circuit 110. Therefore, the solute removal efficiency (dialysis efficiency) can be improved.

(4) In the homogenization step, the control device 140 was made to introduce blood into the blood circuit 110 at a second flow rate and to remove water from the blood purifier 120 at the same flow rate as the second flow rate. As a result, blood removal and water removal are performed even in the homogenization step to improve the solute removal efficiency (dialysis efficiency) and prevent blood from staying between the puncture needle SN and the blood circuit 110. Therefore, the risk of blood coagulation can be reduced.

(5) In the blood return step, the control device 140 was made to return blood by injecting a replacement solution (dialysis solution) into the blood circuit 110 via the replacement solution line 150. As a result, the dialysate can be injected into the blood circuit 110 via the replacement liquid line 150, so that a blood purifier having low water permeability and difficult to back-filter or a laminated blood purifier is used. Also, the blood purification device of the present invention can be applied.

(6) The control device 140 was allowed to perform a water removal step in the blood removal circulation step until the treatment step was repeated a predetermined number of times, and then to perform a filtration step. By controlling the blood removal and circulation step in this way, it is possible to reduce the amount of albumin leaked while improving the efficiency of removing large molecular weight substances in the filtration step.

<Second Embodiment>
Next, a treatment step repeatedly performed using the blood purification device 100 according to the second embodiment 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.
The treatment step of the second embodiment includes a blood removal step, a blood removal circulation step, and a blood return step, and the blood removal circulation step is the same as that described in the first embodiment. The process and the blood return process will be described.

FIG. 10 shows the bilateral blood removal process. In the bilateral blood removal step, the water removal / reverse filtration pump 1333 is driven at a predetermined flow rate (for example, 40 ml / min) as the first flow rate in the water removal direction, and the blood pump 111c is driven by the first flow rate in the forward rotation direction. It is driven at half the flow rate (for example, 20 ml / min). By controlling various pumps in this way, blood can be introduced from both sides of the arterial side line 111 and the venous side line 112 toward the blood purifier 120 via one puncture needle SN. For example, when the internal volume (priming volume) of the blood circuit 110 and the blood purifier 120 is about 200 ml, the bilateral blood removal step takes about 5 minutes. In the blood removal step of the present embodiment, the blood removal step is terminated when the blood reaches the blood purifier 120 without removing water from the blood, and the process proceeds to the next blood removal circulation step. When blood is removed in the bilateral blood removal step, the inside of the blood circuit 110 is almost filled with blood. Therefore, in the next blood removal and circulation step, the blood is not excessively diluted with the dialysate, so that the dialysis efficiency can be improved.

FIG. 11 shows the bilateral blood return process. In the bilateral blood return step of the present embodiment, with the venous side clamp 112d open, the water removal / reverse filtration pump 1333 is driven in the reverse filtration direction at a predetermined flow rate (for example, 60 ml / min), and the replacement liquid is further driven. The pump 151 is driven at the same flow rate as the water removal / reverse filtration pump 1333, and the blood pump 111c is driven in the reverse rotation direction at a flow rate (30 ml / min) that is half of the replacement liquid injection amount. In this way, various pumps and clamps are controlled to inject dialysate as a replacement solution into the arterial side line 111 and the venous side line 112 of the blood circuit 110 via the replacement solution line 150, and one puncture needle SN. Blood is drawn through and returned to the patient. For example, when the internal volume (priming volume) of the blood circuit 110 and the blood purifier 120 is about 200 ml, it takes about 3.3 minutes for the injected replacement solution (dialysis solution) to reach the vicinity of the puncture needle SN. It takes time. After the blood return is completed, the blood circuit 110 has no residual blood and is almost filled with the replacement solution (dialysate solution). Therefore, the homogenization step described in the first embodiment is unnecessary, and the blood circuit 110 is removed in the next treatment step. Move to the blood process. Since it is not necessary to perform the homogenization step in this way, the time of the treatment step (dialysis time) can be shortened by that amount, and the removal efficiency (dialysis efficiency) can be improved. Further, in the present embodiment, the case where the dialysate (replacement solution) is injected into the blood circuit 110 via the replacement solution line 150 to return blood is shown, but when the blood purifier 120 can perform back filtration, , Blood may be returned by injecting a reverse filtration dialysate.

According to the blood purification device 100 of the second embodiment described above, in addition to the above-mentioned effects (1) to (6), the following effects are exhibited.

(7) In the blood removal step, the control device 140 is allowed to remove water at the first flow rate in the blood purifier 120 and to introduce blood into the blood circuit 110 from both the upstream side and the downstream side of the blood purifier 120. It was. As a result, the blood circuit 110 is almost filled with blood, and the blood is not diluted as compared with unilateral blood removal in the blood removal circulation step, so that water can be efficiently removed, and when dialysis is performed, the concentration difference depends on the small amount. The efficiency of removing molecular weight substances can be improved.

(8) In the blood return step, the control device 140 was made to return blood by inflowing a replacement solution (dialysate solution) into all of the blood circuits 110. As a result, the amount of blood removed can be secured in the next blood removal step without performing the homogenization step after the blood return step, and the time required for the treatment step (dialysis time) is shortened, so that the removal efficiency (dialysis) Efficiency) can be improved.

Next, the blood purification apparatus according to the third embodiment and the fourth embodiment of the present invention will be described. The blood purification device according to the third and fourth embodiments is different from the blood purification device according to the first embodiment and the second embodiment in that dialysis is not performed in the blood purifier. In the third embodiment, a blood purification device capable of performing online filtration therapy using a dialysate circuit as a replacement liquid supply source will be described, and in the fourth embodiment, a replacement liquid bottle or a replacement liquid bag will be used as the replacement liquid supply source. A blood purification device capable of performing offline filtration therapy will be described. Further, as in the case of the first embodiment and the second embodiment of the present invention, the blood purification apparatus according to the third embodiment and the fourth embodiment includes a blood removal step, a blood removal circulation step, a blood return step and homogenization. It is an automatic blood purification device that automatically performs each process such as a process continuously and automatically by controlling the flow of injecting a replacement solution into a blood circuit.

<Third Embodiment>
The third embodiment will be described in detail with reference to FIGS. 12 to 14. The same components as those described in the first embodiment and the second embodiment are designated by the same reference numerals, and the description thereof will be omitted.

The blood purification device 100A shown in FIG. 12 includes a blood circuit 110, a blood purifier 120, a dialysate circuit 130A, a control device 140 as a control unit, a replacement liquid line 150, a replacement liquid pump 151, and venous pressure. It includes a sensor PS.

The dialysate circuit 130A is composed of a so-called closed capacity control type dialysate circuit 130A. The dialysate circuit 130A 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. Further, the dialysate circuit 130 is connected to the replacement liquid line 150, which will be described later, and is used as the replacement liquid supply source 152A. Since each configuration of the dialysate circuit 130A is the same as that of the first embodiment and the second embodiment, the description thereof will be omitted, and the dialysate introduction line 132a and the dialysate lead-out line 132b which are connected differently will be described. ..

The dialysate introduction line 132a connects the dialysate chamber 1331 and the dialysate lead-out line 132b, and introduces the dialysate contained in the liquid delivery accommodating portion 1331a of the dialysate chamber 1331 into the dialysate lead-out line 132b.

The dialysate lead-out line 132b connects the dialysate outlet 123b of the blood purifier 120 and the dialysate chamber 1331, and leads out the water discharged from the blood purifier 120 to the drainage accommodating portion 1331b of the dialysate chamber 1331. ..

According to the dialysate circuit 130A described above, 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, in the state where the water removal / reverse filtration pump 1333 is stopped, the dialysate led out from the liquid feed accommodating portion 1331a of the dialysate chamber 1331 is discharged via the dialysate introduction line 132a and the dialysate lead-out line 132b. It is introduced into the liquid accommodating portion 1331b. 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 (filters) 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.

Next, among the treatment steps repeatedly performed using the blood purification device 100A, the blood removal circulation step of performing the water removal step or the filtration step will be described with reference to FIGS. 13 and 14. The blood return step (one side, both sides) and the homogenization step are the same as those described in the first embodiment and the second embodiment, and thus the description thereof will be omitted.

FIG. 13 shows a water removal step performed in the blood removal circulation step. In the water removal step, the blood pump 111c is gradually increased in speed until it reaches a predetermined flow rate (for example, 200 ml / min) in the forward rotation direction, and the water removal / reverse filtration pump 1333 is specified as a second flow rate. It is driven at the water removal rate of (for example, 10 ml / min). Further, with the replacement liquid pump 151 stopped, the dialysate is led out from the liquid supply accommodating portion 1331a of the dialysate chamber 1331 at a predetermined flow rate (for example, 400 ml / min). That is, in the blood purifier 120, a small amount of blood is removed at the same flow rate (second flow rate) as the water removal rate while removing excess water from the patient, and the blood introduced in the blood removal step and newly introduced blood are introduced. The blood to be produced is circulated in the blood circuit 110.

In the water removal step, the replacement solution is not injected into the blood circuit 110, and the blood circulating in the blood circuit 110 is gradually concentrated. Since dialysis is not performed in this embodiment, the effect of removing a small amount of substance cannot be expected in the water removal step, but until the treatment step is repeated a predetermined number of times, the water removal step is performed in the blood removal circulation step to perform the subsequent procedure. The amount of albumin leaked can be reduced in the filtration step.

The water removal step is completed when the blood is concentrated until the hematocrit value reaches a predetermined value, as in the first embodiment and the second embodiment. Then, the process proceeds to the next blood return step.
Further, the water removal step may be completed with the passage of a predetermined time or the arrival of a predetermined water removal amount (blood removal amount) as a guide.

FIG. 14 shows a filtration step performed in the blood removal circulation step. In the filtration step, the blood pump 111c is gradually increased in speed until it reaches a predetermined flow rate (for example, 200 ml / min) in the forward rotation direction, and the water removal / reverse filtration pump 1333 is driven at a predetermined water removal rate (for example, 200 ml / min). , 10 ml / min) in driving further the substitution fluid pump 151 third flow rate as a predetermined replacement fluid rate _{Q R} from the liquid supply housing portion 1331a of the dialysis fluid chamber 1331 while driving at a predetermined flow rate (e.g., 400 + _{Q R} The dialysate is derived at ml / min).
That is, in the filtration step, while injecting dialysate as substitution fluid to the blood circuit 110 at a predetermined flow rate Q _{R (third} flow rate), the water removal of the excess water removal and the patient's waste products in the blood purifier 120 at a flow rate plus substitution fluid injection amount _{Q R} (third flow rate) to the second flow rate is a rate (10 ml / min) performing water removal. Further, a small amount of blood is removed at the same flow rate as the water removal rate (second flow rate), and the blood introduced in the blood removal step and the newly introduced blood are circulated in the blood circuit 110. Further, the circulation flow rate of the blood circuit 110 determined by the flow rate of the blood pump 111c can be arbitrarily set without depending on the blood removal flow rate (second flow rate). Therefore, even if the blood removal flow rate (second flow rate) is small, the circulation flow rate can be increased, and especially in the case of the post-dilution method, it is limited to about 1/4 of the blood flow rate (circulation flow rate) from the viewpoint of blood concentration. The filtration flow rate to be performed can be increased. Therefore, the efficiency of removing solutes can be further improved.
In the filtration step, a large amount of filtration is performed in the blood purifier 120 to mainly remove large molecular weight substances such as low molecular weight proteins. Further, as in the water removal step, the blood circulating in the blood circuit 110 is gradually concentrated, the filtration step is completed based on the blood concentration, elapsed time, water removal amount (blood removal amount), etc., and the next return is performed. Move to the blood process.

According to the blood purification device 100A of the third embodiment described above, in addition to the above-mentioned effects (1) and (3) to (8), the following effects are exhibited.

(9) A blood purification device 100A that alternately performs blood removal and blood return with one puncture needle SN is configured to include a dialysate circuit 130A as a replacement solution supply source, and the dialysate circuit 130A is a blood purifier 120. A blood removal step of introducing blood into the blood circuit 110 at a first flow rate and a second flow rate smaller than the first flow rate to the blood circuit 110 by configuring the control device 140 so as not to allow dialysate to flow into the blood circuit 110. A blood removal circulation step in which blood is introduced and the blood introduced in the blood removal step and the blood introduced in the second flow rate are circulated in the blood circuit 110, and a dialysate is injected into the blood circuit 110 as a replacement solution to form blood. A water removal step or a replacement liquid line in which the blood return step of deriving blood from the circuit and the treatment step including the treatment step are repeated, and the blood removal circulation step is performed by removing water at the same flow rate as the second flow rate in the blood purifier 120. Any of the filtration steps in which the dialysate is injected into the blood circuit 110 via the 150 at a third flow rate and the blood purifier 120 removes water at a flow rate obtained by adding the third flow rate to the second flow rate. On the other hand, I let him do it. As a result, even in online hemofiltration therapy, filtration can be performed at a large filtration flow rate.

<Fourth Embodiment>
The fourth embodiment will be described in detail with reference to FIGS. 15 to 17. Those having the same configuration as those described in the first to third embodiments are designated by the same reference numerals and the description thereof will be omitted.

The blood purification device 100B shown in FIG. 15 includes a blood circuit 110, a blood purifier 120, a control device 140 as a control unit, a replacement liquid line 150, a replacement liquid pump 151, a replacement liquid supply source 152B, and a vein. A pressure sensor PS, a filtrate line 160, and a filtrate pump 161 are provided.

As the replacement liquid supply source 152B, a replacement liquid bottle or a replacement liquid bag filled with the replacement liquid is used. As shown in FIG. 15, the upstream side of the replacement liquid line 150 is connected to the replacement liquid supply source 152B.

The filtrate line 160 is connected to the dialysate outlet 123b of the blood purifier 120, and the filtrate filtered by the blood purifier 120 is discharged.

The filtrate pump 161 is provided on the filtrate line 160 and is a pump for applying negative pressure to the blood purifier 120 to filter the liquid at a predetermined flow rate.

Next, among the treatment steps repeatedly performed using the blood purification device 100B, the blood removal circulation step of performing the water removal step or the filtration step will be described with reference to FIGS. 16 and 17. The blood return step (one side, both sides) and the homogenization step are the same as those described in the first embodiment and the second embodiment, and thus the description thereof will be omitted.

FIG. 16 shows a water removal step performed in the blood removal circulation step. In the water removal step, the blood pump 111c is gradually increased in speed until it reaches a predetermined flow rate (for example, 200 ml / min) in the forward rotation direction, and the filtrate pump 161 is used as a second flow rate to drive the blood pump 111c at a predetermined water removal rate. It is driven at (for example, 10 ml / min). That is, in the blood purifier 120, a small amount of blood is removed at the same flow rate (second flow rate) as the water removal rate while removing excess water from the patient, and the blood introduced in the blood removal step and newly introduced blood are introduced. The blood to be produced is circulated in the blood circuit 110.

In the water removal step, the replacement solution is not injected into the blood circuit 110, and the blood circulating in the blood circuit 110 is gradually concentrated. Since dialysis is not performed in this embodiment, the effect of removing a small amount of substance cannot be expected in the water removal step, but until the treatment step is repeated a predetermined number of times, the water removal step is performed in the blood removal circulation step to perform the subsequent procedure. The amount of albumin leaked can be reduced in the filtration step.

The water removal step is completed when the blood is concentrated until the hematocrit value reaches a predetermined value, as in the first to third embodiments. Then, the process proceeds to the next blood return step.
Further, the water removal step may be completed with the passage of a predetermined time or the arrival of a predetermined water removal amount (blood removal amount) as a guide.

FIG. 17 shows a filtration step performed in the blood removal circulation step. In the filtration step, the blood pump 111c is gradually increased in speed until it reaches a predetermined flow rate (for example, 200 ml / min) in the forward rotation direction, and the replacement liquid pump 151 is used as a third flow rate to drive the replacement liquid at a predetermined flow rate. Q driven by _R, further, the filtrate pump 161 a predetermined water removal speed (e.g., 10 ml / min) to be driven at a speed obtained by adding a predetermined substitution fluid rate _{Q R} (third flow rate). In other words, while injecting the replacement fluid to the blood circuit 110 at a predetermined flow rate Q _{R (third} flow rate), the second flow rate is a water removal rate of excess moisture removal and the patient's waste products in the blood purifier 120 ( performing 10 ml / min) in substitution fluid injection amount _{Q R} (water removal in the third flow rate) was added flow. Further, a small amount of blood is removed at the same flow rate as the water removal rate (second flow rate), and the blood introduced in the blood removal step and the newly introduced blood are circulated in the blood circuit 110. Further, the circulation flow rate of the blood circuit 110 determined by the flow rate of the blood pump 111c can be arbitrarily set without depending on the blood removal flow rate (second flow rate). Therefore, even if the blood removal flow rate (second flow rate) is small, the circulation flow rate can be increased, and especially in the case of the post-dilution method, it is limited to about 1/4 of the blood flow rate (circulation flow rate) from the viewpoint of blood concentration. The filtration flow rate to be performed can be increased. Therefore, the efficiency of removing solutes can be further improved.
In the filtration step, a large amount of filtration is performed in the blood purifier 120 to mainly remove large molecular weight substances such as low molecular weight proteins. Further, as in the water removal step, the blood circulating in the blood circuit 110 is gradually concentrated, the filtration step is completed based on the blood concentration, elapsed time, water removal amount (blood removal amount), etc., and the next return is performed. Move to the blood process.

According to the blood purification device 100B of the fourth embodiment described above, in addition to the above-mentioned effects (1) and (3) to (8), the following effects are exhibited.

(10) In the blood purification device 100B that alternately performs blood removal and blood return with one puncture needle SN, a replacement liquid bottle or a replacement liquid bag is used as the replacement liquid supply source 152B, and the control device 140 and the blood circuit 110 are used. In the blood removal step of introducing blood at the first flow rate, blood is introduced into the blood circuit 110 at a second flow rate smaller than the first flow rate, and the blood introduced in the blood removal step and the second flow rate are used. A treatment step including a blood removal circulation step of circulating the introduced blood in the blood circuit 110 and a blood return step of injecting a replacement solution into the blood circuit 110 to draw blood from the blood circuit is repeated to perform a blood removal circulation step. In the blood purifier 120, the replacement liquid is injected into the blood circuit 110 at the third flow rate through the water removal step of removing water at the same flow rate as the second flow rate, or the replacement liquid line 150, and the blood purifier In 120, one of the filtration steps of removing water at a flow rate obtained by adding a third flow rate to the second flow rate was performed. As a result, even in offline hemofiltration therapy, filtration can be performed at a large filtration flow rate.

Next, the blood purification device according to the fifth embodiment of the present invention will be described. The blood purification device according to the fifth embodiment is different from the blood purification device according to the first embodiment and the second embodiment in that the replacement liquid supply source is not a dialysate circuit, and is different from the blood purification device according to the first embodiment and the second embodiment in that the third embodiment performs filtration and dialysis. It is different from the blood purification device according to the embodiment and the fourth embodiment. In the fifth embodiment, a blood purification device capable of performing offline dialysis filtration therapy using a replacement liquid bottle or a replacement liquid bag as a replacement liquid supply source will be described. Further, as in the case of the first to fourth embodiments of the present invention, the blood purification apparatus according to the fifth embodiment has each step such as a blood removal step, a blood removal circulation step, a blood return step, and a homogenization step. This is an automatic blood purification device that continuously and automatically performs the above by controlling the flow of injecting a replacement solution or dialysate in the blood circuit.

<Fifth Embodiment>
The fifth embodiment will be described in detail with reference to FIGS. 18 to 20. The same components as those described in the first to fourth embodiments are designated by the same reference numerals, and the description thereof will be omitted.

The blood purification device 100C shown in FIG. 18 includes a blood circuit 110, a blood purifier 120, a dialysate circuit 130, a control device 140 as a control unit, a replacement liquid line 150, a replacement liquid pump 151, and a replacement liquid. A supply source 152C and a venous pressure sensor PS are provided.

As the replacement liquid supply source 152C, a replacement liquid bottle or a replacement liquid bag filled with the replacement liquid is used. As shown in FIG. 18, the upstream side of the replacement liquid line 150 is connected to the replacement liquid supply source 152C.

Next, among the treatment steps repeatedly performed using the blood purification device 100C, a blood removal circulation step of performing a dialysis step as a water removal step or a dialysis filtration step as a filtration step will be described with reference to FIGS. 19 and 20. The blood return step (one side, both sides) and the homogenization step are the same as those described in the first and second embodiments, and thus the description thereof will be omitted.

FIG. 19 shows a dialysis step as a water removal step performed in the blood removal circulation step. In the dialysis step, the blood pump 111c is gradually increased in speed until it reaches a predetermined flow rate (for example, 200 ml / min) in the forward rotation direction, and the water removal / back filtration pump 1333 is used as a second flow rate. It is driven at a water removal rate (for example, 10 ml / min). Further, in the dialysate circuit 130, the dialysate is led out to the blood purifier 120 from the dialysate chamber 1331 (delivery solution accommodating portion 1331a) at a predetermined flow rate (for example, 400 ml / min). As a result, the dialysate was introduced into the blood purifier 120 through the dialysate introduction line 132a at a predetermined flow rate (for example, 400 ml / min), and a second flow rate was added to the dialysate lead-out line 132b at a predetermined flow rate. A dialysate containing water removed at a flow rate (eg 410 ml / mim) is derived.
That is, in the blood purifier 120, a small amount of blood is removed at the same flow rate (second flow rate) as the water removal rate while removing excess water and waste products of the patient, and the blood introduced in the blood removal step and The newly introduced blood is circulated in the blood circuit 110.

In the dialysis step, the replacement solution is not injected into the blood circuit 110, and the blood circulating in the blood circuit 110 is gradually concentrated while being dialyzed. As a result, small molecular weight substances such as urea are mainly removed. The dialysis step is performed, for example, by arranging a blood concentration sensor near the blood outlet 122b of the blood purifier 120 and monitoring the hematocrit value, and ends when the blood is concentrated until the hematocrit value reaches a predetermined value. .. Then, the process proceeds to the next blood return step.

FIG. 20 shows a dialysis filtration step performed in the blood removal circulation step. In the dialysis filtration step, the blood pump 111c is gradually increased in speed until it reaches a predetermined flow rate (for example, 200 ml / min) in the forward rotation direction, and the replacement liquid pump 151 is used as a third flow rate to drive the predetermined replacement liquid. speed _Q driven by _R, further water removal / inverse filtering pump 1333 a predetermined water removal speed (e.g., 10 ml / min) the replacement fluid rate _{Q R} (third flow rate) added speed _(Q R + 10 ml / It is driven by min). Further, in the dialysate circuit 130, the dialysate is led out to the blood purifier 120 from the dialysate chamber 1331 (the liquid feed accommodating portion 1331a) at a predetermined flow rate (for example, 400 ml / min). As a result, the dialysate is introduced into the blood purifier 120 through the dialysate introduction line 132a at a predetermined flow rate (for example, 400 ml / min), and the dialysate lead-out line 132b has a second flow rate and a third flow rate at a predetermined flow rate. the dialysate including dewatering and moisture at a flow rate of the added flow (e.g. _{400 + 10 + Q R ml /} mim) is derived.

In other words, while injecting the replacement fluid to the blood circuit 110 at a predetermined flow rate Q _{R (third} flow rate), the second flow rate is a water removal rate of excess moisture removal and the patient's waste products in the blood purifier 120 ( performing 10 ml / min) in substitution fluid injection amount _{Q R} (water removal in the third flow rate) was added flow. Further, a small amount of blood is removed at the same flow rate as the water removal rate (second flow rate), and the blood introduced in the blood removal step and the newly introduced blood are circulated in the blood circuit 110.

Further, the circulation flow rate of the blood circuit 110 determined by the flow rate of the blood pump 111c can be arbitrarily set without depending on the blood removal flow rate (second flow rate). Therefore, even if the blood removal flow rate (second flow rate) is small, the circulation flow rate can be increased, and especially in the case of the post-dilution method, it is limited to about 1/4 of the blood flow rate (circulation flow rate) from the viewpoint of blood concentration. The filtration flow rate to be performed can be increased. Therefore, the efficiency of removing solutes can be further improved.

In the dialysis filtration step, a large amount of filtration is performed in the blood purifier 120 to mainly remove large molecular weight substances such as low molecular weight proteins. Further, as in the dialysis step, the blood circulating in the blood circuit 110 is gradually concentrated, the dialysis filtration step is completed based on the blood concentration, elapsed time, water removal amount (blood removal amount), etc., and the next return is performed. Move to the blood process.

According to the blood purification device 100C of the fifth embodiment described above, in addition to the above-mentioned effects (1) and (3) to (8), the following effects are exhibited.

(11) In the blood purification device 100C in which blood removal and blood return are alternately performed by one piercing needle SN, a replacement liquid bottle or a replacement liquid bag is used as the replacement liquid supply source 152C, and the control device 140 and the blood circuit 110 are used. In the blood removal step of introducing blood at the first flow rate, blood is introduced into the blood circuit 110 at a second flow rate smaller than the first flow rate, and the blood introduced in the blood removal step and the second flow rate are used. A treatment step including a blood removal circulation step of circulating the introduced blood in the blood circuit 110 and a blood return step of injecting a replacement solution into the blood circuit 110 to draw blood from the blood circuit is repeated to perform a blood removal circulation step. In the blood purifier 120, water is removed at the same flow rate as the second flow rate and dialysis is performed, or the replacement solution is injected into the blood circuit 110 via the replacement solution line 150 at the third flow rate to obtain blood. In the purifier 120, water was removed at a flow rate obtained by adding a third flow rate to the second flow rate, and one of the dialysis filtration steps of dialysis was performed. As a result, even in offline hemodialysis filtration therapy, filtration can be performed at a large filtration flow rate.

100, 100A, 100B, 100C Blood purification device 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 150 Replacement liquid line 151 Replacement liquid pump 152A , 152B, 152C Replacement solution source 160 Sulfate line 161 Sulfate pump PS Venous pressure monitor SN Puncture needle

Claims (11)

A blood purification device that alternately removes and returns blood with a single puncture needle.
A blood purifier, a blood circuit, a replacement liquid supply source, a replacement liquid line connecting the blood circuit and the replacement liquid supply source, and a control unit are provided.
The control unit
A blood removal step of introducing blood into the blood circuit at a first flow rate,
Blood is introduced into the blood circuit at a second flow rate smaller than the first flow rate, and the blood introduced in the blood removal step and the blood introduced at the second flow rate are circulated in the blood circuit. Blood removal circulation process and
A treatment step including a blood return step of injecting a replacement solution into the blood circuit and deriving blood from the blood circuit is repeated.
The blood removal circulation step is performed in the blood purifier at the same flow rate as the second flow rate, and / or the replacement liquid is added to the blood circuit via the replacement liquid line at a third flow rate. A blood purification device performed in any of the filtration steps of injecting and removing water at a flow rate obtained by adding the third flow rate to the second flow rate in the blood purifier. A dialysate circuit is provided as the replacement solution supply source, and a dialysate is used as the replacement solution.
The control unit is used in the blood removal circulation step.
As the water removal step, a dialysis step of removing water and dialysis at the same flow rate as the second flow rate is performed in the blood purifier.
As the filtration step, the replacement liquid is injected into the blood circuit through the replacement liquid line at a third flow rate, and the blood purifier removes water at a flow rate obtained by adding the third flow rate to the second flow rate. The blood purification apparatus according to claim 1, wherein the dialysis filtration step of performing dialysis together is performed. A dialysate circuit is provided as the replacement solution supply source, and a dialysate is used as the replacement solution.
The blood purification device according to claim 1, wherein the dialysate circuit is configured so that dialysate does not flow into the blood purifier. The blood purification apparatus according to claim 1, wherein a replacement liquid bottle or a replacement liquid bag filled with the replacement liquid is used as the replacement liquid supply source. As the replacement liquid supply source, a replacement liquid bottle or a replacement liquid bag filled with the replacement liquid is used.
Equipped with dialysate circuit,
The control unit is used in the blood removal circulation step.
As the water removal step, a dialysis step of removing water and dialysis at the same flow rate as the second flow rate is performed in the blood purifier.
As the filtration step, the replacement liquid is injected into the blood circuit through the replacement liquid line at a third flow rate, and the blood purifier removes water at a flow rate obtained by adding the third flow rate to the second flow rate. The blood purification apparatus according to claim 1, wherein the dialysis filtration step of performing dialysis together is performed. In the blood removal step, the control unit removes water at the first flow rate in the blood purifier and introduces blood into the blood circuit from both the upstream side and the downstream side of the blood purifier. Item 4. The blood purification apparatus according to any one of Items 1 to 5. The blood purification apparatus according to any one of claims 1 to 6, wherein the treatment step further includes a homogenization step of circulating and homogenizing the replacement solution of the blood circuit and blood after the blood return step. The seventh aspect of claim 7, wherein the control unit introduces blood into the blood circuit at the second flow rate and removes water at the same flow rate as the second flow rate in the blood purifier in the homogenization step. Blood purification device. The blood purification device according to any one of claims 1 to 6, wherein the control unit causes the replacement liquid to flow into all of the blood circuits to return blood in the blood return step. The blood purification device according to any one of claims 1 to 9, wherein the control unit injects a replacement solution into the blood circuit via the replacement solution line to return blood in the blood return step. The control unit
The blood purification apparatus according to any one of claims 1 to 10, wherein the water removal step is performed in the blood removal circulation step until the treatment step is repeated a predetermined number of times, and then the filtration step is performed.

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