JP7396362B2 - blood purification device - Google Patents

Description

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

BACKGROUND ART As one type of blood purification therapy, blood purification such as hemodialysis using the so-called single needle method, in which blood is alternately removed and returned with a single puncture needle, is known. The single-needle method requires only one puncture, which causes less pain for the patient and less burden on medical personnel than when two punctures are used, and reduces blood loss even if a needle is accidentally pulled out. There are advantages.
However, in the commonly used single-needle method, blood removal and blood return are performed alternately, so the amount of blood circulating through the blood circuit is small, especially when removing relatively large molecular weight substances such as low molecular weight proteins. However, it was difficult to obtain sufficient dialysis efficiency (removal efficiency). Therefore, it is currently difficult to be the first choice of treatment; for example, it is difficult to puncture two regular indwelling needles in elderly patients or patients in the early stages of dialysis because their vascular access is underdeveloped. The single-needle method is indicated for patients who are inactive or who do not require high dialysis efficiency (removal efficiency). In addition, the single needle method is useful for home dialysis patients who can undergo dialysis at any time depending on their physical condition, as the frequency of dialysis increases; be.

Therefore, in order to increase dialysis efficiency (removal efficiency), Patent Document 1 proposes performing hemodiafiltration with a single puncture.
Specifically, there is a circulation process between the blood removal process, in which blood is introduced into a part of the blood circuit through filtration, and the blood return process, in which dialysate is injected into a part of the blood circuit through reverse filtration. This ensures blood flow. In addition, after the blood removal step in which blood is introduced into the entire blood circuit through filtration, the blood is circulated at a blood flow rate greater than the filtration (water removal) rate to ensure the total amount of blood that passes through the blood purifier. It is.

Patent No. 4352775

In the single needle method, blood removal and blood return cannot be performed at the same time, and therefore, a large flow of blood cannot be continuously removed. Therefore, in the method described in Patent Document 1, although it is possible to secure the blood flow rate through circulation, there is a limit to the filtration flow rate, which depends on the drained blood flow rate. Therefore, it has been difficult to further increase the solute removal efficiency, which increases in proportion to the filtration flow rate.

Therefore, an object of the present invention is to provide a blood purification device that can increase the filtration flow rate even when the 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 a single puncture needle, and includes a blood purifier, a blood circuit, a replacement fluid supply source, the blood circuit and the replacement fluid supply source. and a control unit, the control unit including a blood removal step of introducing blood into the blood circuit at a first flow rate, and a substituent line connecting the blood circuit with a blood removal and circulation step in which blood is introduced at a small second 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; and a replacement liquid is introduced into the blood circuit. a blood return step in which the blood is drawn out from the blood circuit by injecting the blood, and the blood removal circulation step is replaced with a blood removal step in which water is removed at the same flow rate as the second flow rate in the blood purifier. A substituent liquid is injected into the blood circuit at a third flow rate through a water process or the substituent line, and water is removed in the blood purifier at a flow rate equal to the third flow rate added to the second flow rate. The present invention relates to a blood purification device that performs any of the filtration steps.

Further, the blood purification device includes a dialysate circuit as the replacement fluid supply source, uses dialysate as the replacement fluid, and the control unit is configured to perform the blood purification as the water removal step in the blood removal and circulation step. A dialysis step is performed in which water is removed and dialyzed at the same flow rate as the second flow rate in the device, and as the filtration step, a replacement fluid is injected into the blood circuit via the replacement fluid line at a third flow rate, In the blood purifier, it is preferable to perform a diafiltration process in which water is removed and dialyzed at a flow rate obtained by adding the third flow rate to the second flow rate.

Further, the blood purification device includes a dialysate circuit as the replacement fluid supply source, uses dialysate as the replacement fluid, and the dialysate circuit is configured to prevent dialysate from flowing into the blood purifier. It is preferable that

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

Further, a substitution liquid bottle or a substitution liquid bag filled with a substitution liquid is used as the substitution liquid supply source, the blood purification apparatus is equipped with a dialysate circuit, and the control unit is configured to: As the water removal step, a dialysis step is performed in which water is removed and dialyzed at the same flow rate as the second flow rate in the blood purifier, and as the filtration step, a replacement fluid is introduced into the blood circuit via the replacement fluid line. It is preferable to perform a diafiltration process in which water is injected at a third flow rate, and water is removed and dialyzed at a flow rate that is the sum of the second flow rate and the third flow rate in the blood purifier.

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

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

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

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

Further, it is preferable that, in the blood return step, the control unit performs blood return by injecting dialysate into the blood circuit via the substituent fluid line.

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

According to the blood purification device of the present invention, in the blood removal and circulation process, a small amount of blood is removed while a filtration process is performed in which water is removed by the amount of blood removed and the amount of replacement fluid injected, thereby increasing the filtration flow rate and removing solutes. Efficiency can be increased.

1 is a diagram showing a schematic configuration of a blood purification device of the present invention. FIG. 1 is a block diagram of a blood purification device of the present invention. It is a figure which shows the unilateral blood removal process in 1st Embodiment. 4 is a diagram showing another example of the unilateral blood removal process shown in FIG. 3. FIG. It is a figure showing the dialysis process of the blood removal circulation process in a 1st embodiment. It is a figure showing the diafiltration process of the blood removal circulation process in a 1st embodiment. It is a figure which shows the unilateral blood return process in 1st Embodiment. It is a figure showing a homogenization process in a 1st embodiment. 9 is a diagram showing another example of the homogenization process shown in FIG. 8. FIG. It is a figure which shows the both-side blood removal process in 2nd Embodiment. It is a figure which shows the bilateral blood return process in 2nd Embodiment. It is a figure showing the schematic structure of the blood purification device concerning a 3rd embodiment of the present 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 showing the schematic structure of the blood purification device concerning a 4th embodiment of the present 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 showing the schematic structure of the blood purification device concerning a 5th embodiment of the present 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 diafiltration process of the blood removal circulation process in 5th Embodiment.

Hereinafter, preferred embodiments of the blood purification device 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 is capable of performing blood purification by the so-called single needle method in which blood is removed and returned with a single puncture needle, and a replacement fluid can be injected into the blood circuit. It is configured to be able to carry out dialysis therapy that does not involve dialysis, and online diafiltration therapy that purifies the blood while injecting a replacement fluid into the blood circuit and filtering an equivalent amount of the replacement fluid. In addition, the blood purification apparatus according to the first and second embodiments of the present invention performs each process such as a blood removal process, a blood removal circulation process, a blood return process, and a homogenization process in the flow of injecting dialysate in the blood circuit. This is an automatic blood purification device that performs continuous and automatic blood purification by controlling.
In the first embodiment, a blood purification device that repeatedly performs a treatment process including a blood removal process, a blood removal circulation process, a blood return process, and a homogenization process will be described. A blood purification device that repeatedly performs 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 apparatus 100 shown in FIG. A sensor PS is provided.

The blood circuit 110 includes an arterial line 111, a venous line 112, and a drainage line 113. The arterial line 111, the venous line 112, and the drainage line 113 are all mainly composed of flexible tubes through which liquid can flow.

One end of the arterial line 111 is connected to a blood inlet 122a of a blood purifier 120, which will be described later. The artery side line 111 is provided with an artery side connection part 111a, an artery side air bubble detector 111b, and a blood pump 111c.
The artery side connection part 111a is arranged at the other end side of the artery side line 111, and connects one puncture needle SN to be punctured into a patient's blood vessel via a branch pipe BP configured in a Y-shape or a T-shape. connected to.
The arterial air bubble detector 111b detects the presence or absence of air bubbles within the tube.
The blood pump 111c is arranged downstream of the arterial air bubble detector 111b in the arterial line 111. The blood pump 111c pumps out liquid such as blood and priming liquid 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 a blood outlet 122b of a blood purifier 120, which will be described later. The venous line 112 is provided with a venous connection part 112a, a venous bubble detector 112b, a drip chamber 112c, and a venous clamp 112d.
The venous side connection part 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 pipe BP to which the above-mentioned arterial side connection part 111a is connected.
The venous air bubble detector 112b detects the presence or absence of air bubbles within the tube.
The drip chamber 112c is arranged upstream of the venous bubble detector 112b. The drip chamber 112c stores a certain amount of blood or air in order to remove air bubbles, coagulated blood, etc. mixed into the venous line 112, and to measure venous pressure.
The venous clamp 112d is arranged downstream of the venous bubble detector 112b. The venous clamp 112d is controlled according to the result of bubble detection by the venous bubble detector 112b, and opens and closes the flow path of the venous line 112.

Drain line 113 is connected to drip chamber 112c. A drain line clamp 113a is arranged on the drain line 113. The drain line 113 is a line for draining a priming liquid in a priming process for washing and cleaning the blood circuit 110 and the blood purifier 120.

The blood purifier 120 includes a cylindrical container body 121 and a dialysis membrane (not shown) housed inside the container body 121. It is divided into a side channel and a dialysate side channel (both not shown). The container body 121 is formed with a blood inlet 122a and a blood outlet 122b that communicate with the blood circuit 110, and a dialysate inlet 123a and a dialysate outlet 123b that communicate with the dialysate circuit 130.

The dialysate circuit 130 is configured by a so-called sealed volume control type dialysate circuit 130. The dialysate circuit 130 includes a dialysate supply line 131a, a dialysate drain line 131b, a dialysate introduction line 132a, a dialysate outlet line 132b, and a dialysate feed section 133. Further, the dialysate circuit 130 is connected to a substituent line 150, which will be described later, and is used as a substituent liquid supply source 152.

The dialysate feeding 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 that can contain a fixed volume (for example, 300 mL to 500 mL) of dialysate, and the interior of this container is separated by a soft diaphragm from the fluid supply storage section 1331a and the drain fluid. It is divided into a housing section 1331b.
Bypass line 1332 connects dialysate lead-out line 132b and dialysate drain line 131b.

A water removal/reverse filtration pump 1333 is located in the bypass line 1332. The water removal/reverse filtration pump 1333 is configured to flow the dialysate inside the bypass line 1332 toward the dialysate drainage line 131b side (water removal direction) and to flow the dialysate fluid through the dialysate outlet line 132b side (reverse filtration direction). It is composed of a pump that can be driven to send liquid to.

The dialysate supply line 131a is connected to a dialysate supply device (not shown) at its proximal end and to the dialysate chamber 1331 at its distal end. The dialysate supply line 131a supplies dialysate to the liquid supply storage section 1331a of the dialysate chamber 1331.

The dialysate introduction line 132 a connects the dialysate chamber 1331 and the dialysate inlet 123 a of the blood purifier 120 , and transfers the dialysate contained in the liquid supply storage section 1331 a of the dialysate chamber 1331 to the blood purifier 120 for dialysis. Introduced into the liquid side channel.

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 drain fluid storage section 1331b of the dialysate chamber 1331. do.

The dialysate drain line 131b is connected at its proximal end to the dialysate chamber 1331, and discharges the dialysate contained in the drain fluid storage section 1331b.

According to the dialysate circuit 130 described above, by dividing the inside of the hard container constituting the dialysate chamber 1331 with a soft diaphragm, the amount of dialysate drawn out from the dialysate chamber 1331 (liquid supply capacity The amount of dialysate supplied to the dialysate chamber 1331a (the amount of dialysate supplied to the dialysate chamber 1331a) and the amount of drainage fluid collected in the dialysate chamber 1331 (drainage fluid storage 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 (effluent) drawn out from the blood purifier 120 are made equal to each other. Can be done. Further, when the water removal/reverse filtration pump 1333 is driven to send liquid in the water removal direction, a predetermined amount of water is removed (filtered) from the blood at a predetermined speed in the blood purifier 120. Further, when the water removal/back filtration pump 1333 is driven to send liquid in the back filtration direction, a predetermined amount of dialysate is injected into the blood circuit 110 in the blood purifier 120 (back filtration).

The control device 140 is constituted by 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, etc. arranged in the blood circuit 110 and the dialysate circuit 130, and controls various operations performed by the blood purification device 100. Steps such as a blood removal step, a blood removal circulation step, a blood return step, and a homogenization step are performed.

The replacement fluid line 150 is a line for directly injecting the dialysate in the dialysate circuit 130 used as a replacement fluid supply source 152 into the blood circuit 110 as a replacement fluid, and is a flexible line that allows fluid to flow through it. It is mainly composed of tubes. As shown in FIG. 1, the upstream side of the replacement fluid line 150 is connected to the dialysate introduction line 132a of the dialysate circuit 130. The downstream side of the substitution fluid line 150 is connected to the arterial line 111 which is upstream of the blood purifier 120 in the case of the pre-dilution method, and connected to the venous line 111 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 substituent fluid pump 151 is disposed in the substituent fluid line 150, takes out dialysate as a substituent fluid from the dialysate circuit 130 (substitute fluid supply source 152), and supplies the dialysate to the blood circuit 110 (arterial line 111 or venous line 112). Send liquid to.

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

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

Figure 3 shows the unilateral 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 line 111 and the blood purifier 120 through one puncture needle SN. For example, when the internal volume (priming volume) of the arterial line 111 and the blood purifier 120 is about 100 ml, the one-sided blood removal process requires about 2.5 minutes.
In the blood removal process of this embodiment, water is not removed from the blood that has been removed, and when the blood reaches the blood purifier 120, the blood removal process is ended and the next blood removal circulation process is started. The blood removal step in the first treatment step is performed after the priming step, and is performed with the blood circuit 110 filled with dialysate as a priming fluid. When the first blood removal step is completed, the venous line 112 is filled with dialysate as a priming fluid.
In this embodiment, an example in which the arterial line 111 is used as an example of the unilateral blood removal process is shown, but the blood pump 111c may be stopped and blood may be removed using the venous line 112.

Further, as shown in FIG. 4, as another example of the one-sided blood removal process, with the venous side clamp 112d closed, the water removal/reverse filtration pump 1333 is not driven, and the blood pump 111c is rotated in the forward rotation direction. Blood may be introduced into the arterial line 111 and the blood purifier 120 through one puncture needle SN by driving at a predetermined flow rate (for example, 40 ml/min) as the first flow rate. 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, the blood removal step is completed, and the next blood removal circulation step is started.

FIG. 5 shows a dialysis process as a water removal process performed in the blood removal and circulation process. In the dialysis process, the blood pump 111c is driven in the forward rotation direction at a gradually increasing speed until a predetermined flow rate (for example, 200 ml/min) is reached, and the water removal/reverse filtration pump 1333 is driven as a second flow rate at a predetermined 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 from the dialysate chamber 1331 (liquid feeding storage section 1331a) to the blood purifier 120 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 is introduced into the dialysate outlet line 132b at a predetermined flow rate plus a second flow rate. A dialysate containing water from which water has been removed is discharged at a flow rate (for example, 410 ml/mim).
That is, in the blood purifier 120, a small amount of blood is removed at the same flow rate as the water removal rate (second flow rate) while removing excess water and waste from the patient, and the blood introduced in the blood removal process and The newly introduced blood is circulated in the blood circuit 110.
In the dialysis process, the blood circulating in the blood circuit 110 is gradually concentrated while being dialyzed without injecting a substituent into the blood circuit 110. This mainly removes small molecular weight substances such as urea. The dialysis process is performed while monitoring the hematocrit value by placing a blood concentration sensor near the blood outlet 122b of the blood purifier 120, and ends when the blood is concentrated until the hematocrit value reaches a predetermined value. . Then, the process moves to the next blood return process.
It is known that as the concentration of blood increases, the viscosity of blood also increases, and particularly when the hematocrit value exceeds 50%, the viscosity increases rapidly. Due to the increase in viscosity, the dialysis membrane of the blood purifier 120 becomes easily clogged, leading to deterioration of the dialysis membrane. Therefore, it is preferable to concentrate blood so that the hematocrit value does not exceed 50%.
Further, the dialysis step may be terminated after a predetermined time has elapsed or when a predetermined water removal amount (blood removal amount) is reached.

FIG. 6 shows a diafiltration process as a filtration process performed in the blood removal and circulation process. In the diafiltration process, the blood pump 111c is driven in the forward rotation direction at a gradually increasing speed until a predetermined flow rate (for example, 200 ml/min) is reached, and the water removal/reverse filtration pump 1333 is driven at a predetermined water removal rate (for example, 200 ml/min). For example, the substituent liquid pump 151 is driven at a predetermined substituent liquid rate _QR as a third flow rate. Further, in the dialysate circuit 130, the dialysate is led out from the dialysate chamber 1331 (liquid feeding storage section 1331a) to the blood purifier 120 at a predetermined flow rate (for example, 400+Q _R 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 is introduced into the dialysate outlet line 132b at a predetermined flow rate, a second flow rate, and a third flow rate. A dialysate containing water from which water has been removed is delivered at a flow rate (for example, 400 + 10 + Q _R ml/mim).

That is, in the diafiltration process, while injecting dialysate as a replacement fluid into the blood circuit 110 at a predetermined flow rate Q _R (third flow rate), the blood purifier 120 removes waste products and dehydrates the patient's excess water. Water removal is performed at a flow rate that is the sum of the second flow rate (10 ml/min) and the replacement liquid injection amount Q _R (third flow rate). 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 process 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 hemoconcentration. The filtration flow rate can be increased. Therefore, the solute removal efficiency can be further improved.
In the diafiltration process, 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. In addition, similarly to the dialysis process, the blood circulating in the blood circuit 110 is gradually concentrated, and the diafiltration process is completed based on the blood concentration, elapsed time, amount of water removed (blood removal amount), etc., and then the next return is performed. Move on to the blood process.

FIG. 7 shows the unilateral blood return process. In the unilateral blood return step of this embodiment, the blood pump 111c is stopped, 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. Furthermore, the substituent liquid pump 151 is driven at the same flow rate as the water removal/reverse filtration pump 1333. By controlling the various pumps and clamps in this way, dialysate (substitute fluid) is injected into the blood circuit 110 via the substituent line 150, and blood is drawn from the venous line 112 via the single puncture needle SN. and return blood to the patient. For example, if the internal volume (priming volume) of the venous line 112 and 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 next homogenization step is started. The arterial line 111, which is not used for blood return, is filled with concentrated blood.
In this embodiment, an example is shown in which the venous line 112 is used as an example of the unilateral blood return process, 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, and the arterial Blood may be returned using the side line 111. Furthermore, in this embodiment, a case has been described in which dialysate (substitute fluid) is injected into the blood circuit 110 via the substituent fluid line 150 to return blood. Depending on the situation, blood may be returned.

FIG. 8 shows the homogenization process. The homogenization process is performed when concentrated blood remains in the blood circuit 110 after the blood return process, and blood is removed in the blood removal process via the line in which the blood remains. This is a step of circulating the dialysate (substitute fluid) and blood in the 110 to homogenize their concentrations. By performing this homogenization step, the remaining blood is prevented from being excessively concentrated in the blood removal step, and the amount of blood removed is ensured. Further, by circulating the dialysate at a predetermined flow rate in the dialysate circuit 130, the dialysate flows into the blood purifier 120, and small molecular weight substances are removed (dialysis) by diffusion.
In this embodiment, the dialysate is passed through the dialysate circuit 130 at a rate of 400 ml/min while the water removal/reverse filtration pump 1333 and the substituent pump 151 are stopped, and the blood pump 111c, for example, is rotated forward at a rate of 200 ml/min. The remaining blood and dialysate are circulated and homogenized, and dialysis is performed.

In addition, 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, for example, to remove water from the patient's body fluid while homogenizing it, and to remove a small amount of blood. It's okay. In this way, by continuing water removal while removing a small amount of blood in the homogenization step following the blood removal circulation step, the time required to remove a predetermined amount of water from the patient's body fluid can be reduced. It is possible to shorten the time and improve dialysis efficiency (removal efficiency).

In this way, after the homogenization process is performed for several minutes, it is completed and the next treatment process, the blood removal process, is started.

In the blood removal step in the second and subsequent treatment steps, blood diluted with the dialysate remains.
For example, in the second and subsequent blood removal steps, if water is removed at a rate of 40 ml/min as explained in FIG. 3, the diluted blood remaining in the arterial line 111 will be concentrated. If an attempt is made to filter all of the diluted blood remaining in the arterial line 111, the blood will become excessively concentrated, and the blood will coagulate in the blood purifier 120, causing a blockage. Therefore, a blood concentration sensor is installed in the line used for blood removal, and while water is removed until a predetermined concentration (for example, 50% in terms of hematocrit value) is reached, an amount of blood corresponding to the amount of water removed is removed and the blood circuit is removed. is newly introduced to complete the blood removal process and move on to the next blood removal circulation process.

By repeating the treatment steps described above, water removal and solute removal are performed.

As described above, in this embodiment, either one of the dialysis process as a water removal process and the diafiltration process as a filtration process is selected and implemented in the blood removal and circulation process. The control method in the blood removal circulation process will be explained below.
In diafiltration, in which the filtration flow rate in the blood purifier 120 increases in order to filter the replacement fluid injected into the blood circuit 110, the amount of albumin leaked becomes excessive at the beginning of treatment, and after a certain period of time, the leaked amount decreases. It has been reported that this will happen. Therefore, in the blood purification device 100 of the present embodiment, the dialysis process is performed as a water removal process in the blood removal circulation process until the albumin leakage decreases, that is, until the treatment process is repeated a predetermined number of times, and then the blood removal circulation process is performed. It is preferable to perform a diafiltration step as a filtration step in the process. As a result, in the first half of blood purification therapy, the filtration flow rate is set to a low flow rate that is similar to the water removal rate used to remove excess water from the patient, suppressing the leakage of albumin, and dialysis mainly removes small molecular weight substances. In the second half, the filtration flow rate is increased to mainly remove large molecular weight substances. By controlling the blood removal circulation process in this manner, the amount of albumin leakage can be reduced while improving the removal efficiency of both small and large molecular weight substances.

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

(1) In the blood purification device 100 that alternately performs blood removal and blood return with one puncture needle SN, the control device 140 is configured to perform a blood removal process in which blood is introduced into the blood circuit 110 at a first flow rate, and a blood circuit a blood removal circulation step in which 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 blood introduced at the second flow rate are circulated in the blood circuit 110; A treatment process including a blood return process in which a replacement fluid is injected into the blood circuit 110 and blood is drawn out from the blood circuit is repeatedly performed, and a blood removal circulation process is performed in the blood purifier 120 at the same flow rate as the second flow rate. In the water removal process, or injecting the substituting liquid into the blood circuit 110 via the substituting liquid line 150 at a third flow rate, the blood purifier 120 uses a flow rate that is the sum of the second flow rate and the third flow rate. One of the filtration steps to remove water was performed. As a result, in the filtration process performed in the blood removal circulation process, even if the blood removal flow rate (second flow rate) is as small as the water removal rate for removing excess water from the patient, a large filtration rate can be achieved. Filtration can be performed at a flow rate, and the removal efficiency of mainly large molecular weight substances (low molecular weight proteins) can be increased. In addition, in the blood removal circulation process, the blood removal flow rate (second flow rate) is a small flow rate that is about the same as the water removal rate for removing excess water from the patient, so the time of the blood removal circulation process can be lengthened. This allows the treatment process to take longer. Therefore, the number of repetitions of the treatment process can be reduced, and the time required for the blood removal process and blood return process has little effect on the time required for dialysis treatment. ) and the blood flow rate (return blood flow rate) in the blood return step need not be increased. Therefore, the present invention can also be applied to patients with low blood flow through vascular access. 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 hemoconcentration. The filtration flow rate can be increased. Therefore, the solute removal efficiency can be further improved. Furthermore, because of its high dialysis efficiency, it can be applied to patients who were not previously eligible for single-needle therapy.

(2) The blood purification device 100 is configured to include the dialysate circuit 130 as the substituent fluid supply source 152, the dialysate is used as the substituent fluid, and the control device 140 is configured to include the dialysate circuit 130 as the substituent fluid supply source 152. A dialysis process is performed in which water is removed and dialysis is performed at the same flow rate as that of the blood purifier 120 , and as a filtration process, the substitution liquid is injected into the blood circuit 110 via the substitution liquid line 150 at a third flow rate. A diafiltration process was performed in which water was removed and dialyzed at a flow rate that was the sum of the second flow rate and the third flow rate. Thereby, the removal efficiency of both small molecular weight substances and large molecular weight substances can be improved.

(3) In the treatment process, in the blood return process, replacement fluid (dialysate) is flowed into a part of the blood circuit 110 to return the blood, and blood that is not returned to the line used for blood removal in the blood circuit 110 is If there remains, a homogenization step is further included in which the replacement fluid (dialysate) and blood in the blood circuit 110 are circulated and homogenized after the blood return step. This prevents over-concentration of residual blood in the blood removal process, and also ensures the amount of blood newly introduced into the blood circuit 110. Therefore, solute removal efficiency (dialysis efficiency) can be improved.

(4) In the homogenization process, the control device 140 introduced blood into the blood circuit 110 at the second flow rate and caused the blood purifier 120 to remove water at the same flow rate as the second flow rate. As a result, by removing blood and removing water even in the homogenization process, solute removal efficiency (dialysis efficiency) is improved and blood is prevented from stagnation between the puncture needle SN and the blood circuit 110. This can reduce the risk of blood coagulation.

(5) In the blood return process, the control device 140 was caused to inject a substituent fluid (dialysate) into the blood circuit 110 via the substituent fluid line 150 to return blood. As a result, the dialysate can be injected into the blood circuit 110 via the substitution fluid line 150, so that it is possible to inject the dialysate into the blood circuit 110, even when using a blood purifier with low water permeability that makes backfiltration difficult or a laminated blood purifier. The blood purification device of the present invention can also be applied.

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

<Second embodiment>
Next, a treatment process repeatedly performed using the blood purification apparatus 100 according to the second embodiment will be described with reference to FIGS. 10 and 11. Components having the same configuration as those described in the first embodiment are given the same reference numerals, and the description thereof will be omitted.
The treatment process of the second embodiment includes a blood removal process, a blood removal circulation process, and a blood return process, and the blood removal and circulation process is the same as that described in the first embodiment, so the explanation will be omitted. The process and blood return process will be explained.

Figure 10 shows the bilateral blood removal process. In the double-sided blood removal step, the water removal/reverse filtration pump 1333 is driven in the water removal direction at a predetermined flow rate (for example, 40 ml/min) as the first flow rate, and the blood pump 111c is driven in the forward rotation direction at the first flow rate. drive at half the flow rate (for example, 20 ml/min). By controlling the various pumps in this way, blood can be introduced toward the blood purifier 120 from both sides of the arterial line 111 and the venous line 112 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 process takes about 5 minutes. In the blood removal process of this embodiment, water is not removed from the blood, and the blood removal process is ended when the blood reaches the blood purifier 120, and the next blood removal circulation process is started. When blood is removed in the bilateral blood removal process, 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 diluted excessively with the dialysate, so that the dialysis efficiency can be improved.

FIG. 11 shows the bilateral blood return process. In the bilateral blood return process of this 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 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 direction at a flow rate (30 ml/min) that is half the amount of substituent injected. By controlling the various pumps and clamps in this way, dialysate as a replacement fluid is injected into the arterial line 111 and venous line 112 of the blood circuit 110 via the replacement fluid line 150, and one puncture needle SN and return the blood to the patient. For example, if the internal volume (priming volume) of the blood circuit 110 and blood purifier 120 is about 200 ml, it takes about 3.3 minutes for the injected replacement fluid (dialysate) to reach the vicinity of the puncture needle SN. It takes time. After the blood return is completed, there is no residual blood in the blood circuit 110 and it is almost filled with the replacement fluid (dialysate), so the homogenization step described in the first embodiment is unnecessary, and the desorption process in the next treatment step is unnecessary. Move on 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 accordingly, and the removal efficiency (dialysis efficiency) can be improved. Furthermore, in this embodiment, a case has been described in which dialysate (substitute fluid) is injected into the blood circuit 110 via the substitution fluid line 150 to return blood, but if back filtration is possible in the blood purifier 120, , blood may be returned by injecting back-filtered dialysate.

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

(7) In the blood removal process, the control device 140 performs water removal in the blood purifier 120 at the first flow rate, and causes the blood to be introduced into the blood circuit 110 from both the upstream and downstream sides of the blood purifier 120. Ta. As a result, the blood circuit 110 is almost filled with blood, and the blood is not diluted in the blood removal circulation process compared to unilateral blood removal, so water can be efficiently removed. The removal efficiency of molecular weight substances can be improved.

(8) In the blood return step, the control device 140 caused the replacement fluid (dialysate) to flow into all of the blood circuits 110 to return blood. As a result, the amount of blood removed can be secured in the next blood removal process without the need for a homogenization process after the blood return process, and the time required for the treatment process (dialysis time) is shortened, so the removal efficiency (dialysis time) is reduced. efficiency).

Next, blood purification devices according to the third and fourth embodiments of the present invention will be described. The blood purification apparatuses according to the third and fourth embodiments differ from the blood purification apparatuses according to the first and second embodiments in that dialysis is not performed in the blood purifier. In the third embodiment, a blood purification device that can perform online filtration therapy using a dialysate circuit as a substituent fluid supply source will be described, and in the fourth embodiment, a substituent bottle or a substituent bag is used as a substituent fluid supply source. A blood purification device capable of performing offline filtration therapy will be described. Further, as in the first and second embodiments of the present invention, the blood purification apparatuses according to the third and fourth embodiments include a blood removal process, a blood removal circulation process, a blood return process, and a homogenization process. This is an automatic blood purification device that automatically performs each process continuously by controlling the flow of injecting a replacement fluid into the blood circuit.

<Third embodiment>
The third embodiment will be described in detail with reference to FIGS. 12 to 14. Components similar to those described in the first embodiment and the second embodiment are given the same reference numerals and the description thereof will be omitted.

The blood purification apparatus 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 section, a substituent line 150, a substituent pump 151, and a venous pressure A sensor PS is provided.

The dialysate circuit 130A is configured by a so-called sealed volume control type dialysate circuit 130A. The dialysate circuit 130A includes a dialysate supply line 131a, a dialysate drain line 131b, a dialysate introduction line 132a, a dialysate outlet line 132b, and a dialysate feed section 133. Further, the dialysate circuit 130 is connected to a substituent line 150, which will be described later, and is used as a substituent liquid supply source 152A. Each configuration of the dialysate circuit 130A is the same as that of the first embodiment and the second embodiment, so the explanation will be omitted, and the dialysate introduction line 132a and dialysate output line 132b, which are connected differently, will be explained. .

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 feeding storage section 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 the water discharged from the blood purifier 120 to the drain fluid storage section 1331b of the dialysate chamber 1331. .

According to the above dialysate circuit 130A, by dividing the inside of the hard container constituting the dialysate chamber 1331 with a soft diaphragm, the amount of dialysate drawn out from the dialysate chamber 1331 (liquid supply capacity The amount of dialysate supplied to the dialysate chamber 1331a (the amount of dialysate supplied to the dialysate chamber 1331a) and the amount of drainage fluid collected in the dialysate chamber 1331 (drainage fluid storage section 1331b) can be made equal.
As a result, when the water removal/reverse filtration pump 1333 is stopped, the dialysate drawn out from the liquid supply storage section 1331a of the dialysate chamber 1331 is discharged via the dialysate introduction line 132a and the dialysate outlet line 132b. The liquid is introduced into the liquid storage section 1331b. Further, when the water removal/reverse filtration pump 1333 is driven to send liquid in the water removal direction, a predetermined amount of water is removed (filtered) from the blood at a predetermined speed in the blood purifier 120. Further, when the water removal/back filtration pump 1333 is driven to send liquid in the back filtration direction, a predetermined amount of dialysate is injected into the blood circuit 110 in the blood purifier 120 (back filtration).

Next, among the treatment steps repeatedly performed using the blood purification device 100A, a blood removal circulation step in which a water removal step or a filtration step is performed will be described with reference to FIGS. 13 and 14. The blood return process (on one side, both sides) and the homogenization process are the same as those described in the first embodiment and the second embodiment, so their explanation will be omitted.

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

In the water removal step, the blood circulating in the blood circuit 110 is gradually concentrated without injecting a replacement liquid into the blood circuit 110. Since dialysis is not performed in this embodiment, the effect of removing small amounts of substances cannot be expected in the water removal process, but until the treatment process is repeated a predetermined number of times, the water removal process can be performed in the blood removal and circulation process, so that it can be carried out later. It is possible to reduce the amount of albumin leaked in the filtration process.

The water removal step ends when the blood is concentrated until the hematocrit value reaches a predetermined value, similarly to the first and second embodiments. Then, the process moves to the next blood return process.
Further, the water removal step may be terminated after a predetermined time has elapsed or when a predetermined water removal amount (blood removal amount) is reached.

FIG. 14 shows the filtration step performed in the blood removal circulation step. In the filtration process, the blood pump 111c is driven in the forward rotation direction at a gradually increasing speed until a predetermined flow rate (for example, 200 ml/min) is reached, and the water removal/reverse filtration pump 1333 is driven at a predetermined water removal rate (for example, 200 ml/min). , 10 ml/min), and while driving the substituent liquid pump 151 at a predetermined substituate rate Q _R as the third flow rate, a predetermined flow rate (for example, 400+Q _R ml/min).
That is, in the filtration step, while injecting dialysate as a replacement fluid into the blood circuit 110 at a predetermined flow rate Q _R (third flow rate), the blood purifier 120 removes waste products and dehydrates the patient's excess water. Water removal is performed at a flow rate that is the sum of the second flow rate (10 ml/min) and the replacement liquid injection amount Q _R (third flow rate). 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 process 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 hemoconcentration. The filtration flow rate can be increased. Therefore, the solute removal efficiency can be further improved.
In the filtration process, 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. In addition, similarly to the water removal process, the blood circulating in the blood circuit 110 is gradually concentrated, and the filtration process is completed based on the blood concentration, elapsed time, water removal amount (blood removal amount), etc., and then the next return Move on to the blood process.

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

(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 fluid supply source, and the dialysate circuit 130A is connected to a blood purifier 120. The control device 140 performs 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 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 blood introduced at a second flow rate are circulated in the blood circuit 110, and a dialysate is injected as a replacement fluid into the blood circuit 110 to remove the blood. A treatment process including a blood return process in which blood is drawn out from the circuit is repeated, and the blood removal circulation process is replaced by a water removal process in which water is removed at the same flow rate as the second flow rate in the blood purifier 120, or a replacement liquid line. A filtration process in which dialysate is injected as a replacement fluid into the blood circuit 110 at a third flow rate via the blood purifier 120 and water is removed at a flow rate that is the sum of the second flow rate and the third flow rate. I had him do it on the other hand. Thereby, even in online hemofiltration therapy, filtration can be performed with a large filtration flow rate.

<Fourth embodiment>
The fourth embodiment will be described in detail with reference to FIGS. 15 to 17. Components having the same configuration as those described in the first to third embodiments are given 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 section, a substitution fluid line 150, a substitution fluid pump 151, a substitution fluid supply source 152B, and a vein. It includes a pressure sensor PS, a filtrate line 160, and a filtrate pump 161.

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

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

The filtrate pump 161 is a pump that is provided in the filtrate line 160 and applies 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, a blood removal circulation step in which a water removal step or a filtration step is performed will be described with reference to FIGS. 16 and 17. The blood return process (on one side, both sides) and the homogenization process are the same as those described in the first embodiment and the second embodiment, so their explanation will be omitted.

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

In the water removal step, the blood circulating in the blood circuit 110 is gradually concentrated without injecting a replacement liquid into the blood circuit 110. Since dialysis is not performed in this embodiment, the effect of removing small amounts of substances cannot be expected in the water removal process, but until the treatment process is repeated a predetermined number of times, the water removal process can be performed in the blood removal and circulation process, so that it can be carried out later. It is possible to reduce the amount of albumin leaked in the filtration process.

Similar to the first to third embodiments, the water removal step ends when the blood is concentrated until the hematocrit value reaches a predetermined value. Then, the process moves to the next blood return process.
Further, the water removal step may be terminated after a predetermined time has elapsed or when a predetermined water removal amount (blood removal amount) is reached.

FIG. 17 shows the filtration step performed in the blood removal circulation step. In the filtration step, the blood pump 111c is driven in the forward rotation direction at a gradually increasing speed until a predetermined flow rate (for example, 200 ml/min) is reached, and the substituent liquid pump 151 is driven at a third flow rate to maintain a predetermined substituent liquid rate. Q _R , and the filtrate pump 161 is further driven at a predetermined water removal rate (for example, 10 ml/min) plus a predetermined replacement liquid rate Q _R (third flow rate). In other words, while injecting the replacement fluid into the blood circuit 110 at a predetermined flow rate Q _R (third flow rate), the blood purifier 120 removes waste products and the second flow rate ( Water removal is performed at a flow rate equal to 10 ml/min) plus the replacement liquid injection amount Q _R (third flow rate). 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 process 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 hemoconcentration. The filtration flow rate can be increased. Therefore, the solute removal efficiency can be further improved.
In the filtration process, 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. In addition, similarly to the water removal process, the blood circulating in the blood circuit 110 is gradually concentrated, and the filtration process is completed based on the blood concentration, elapsed time, water removal amount (blood removal amount), etc., and then the next return Move on to the blood process.

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

(10) In the blood purification device 100B that performs blood removal and blood return alternately with one puncture needle SN, a replacement fluid bottle or a replacement fluid bag is used as the replacement fluid supply source 152B, and the blood circuit 110 is connected to the control device 140. A blood removal process in which blood is introduced at a first flow rate, and 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 process and the second flow rate are The blood removal and circulation process includes a blood removal and circulation process in which introduced blood is circulated through the blood circuit 110, and a blood return process in which a replacement fluid is injected into the blood circuit 110 and blood is drawn out from the blood circuit, and the blood removal and circulation process is performed repeatedly. A water removal step is performed in which water is removed at the same flow rate as the second flow rate in the blood purifier 120, or a replacement liquid is injected into the blood circuit 110 at a third flow rate via the replacement liquid line 150, and the blood purifier At step 120, one of the filtration steps was performed in which water was removed at a flow rate that was the sum of the second flow rate and the third flow rate. Thereby, even in offline hemofiltration therapy, filtration can be performed with a large filtration flow rate.

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

<Fifth embodiment>
The fifth embodiment will be described in detail with reference to FIGS. 18 to 20. Components similar to those described in the first to fourth embodiments are given the same reference numerals and descriptions 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 section, a replacement fluid line 150, a replacement fluid pump 151, and a replacement fluid. It includes a supply source 152C and a venous pressure sensor PS.

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

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

FIG. 19 shows a dialysis process as a water removal process performed in the blood removal and circulation process. In the dialysis process, the blood pump 111c is driven in the forward rotation direction at a gradually increasing speed until a predetermined flow rate (for example, 200 ml/min) is reached, and the water removal/reverse filtration pump 1333 is driven as a second flow rate at a predetermined 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 from the dialysate chamber 1331 (liquid feeding storage section 1331a) to the blood purifier 120 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 is introduced into the dialysate outlet line 132b at a predetermined flow rate plus a second flow rate. A dialysate containing water from which water has been removed is discharged at a flow rate (for example, 410 ml/mim).
That is, in the blood purifier 120, a small amount of blood is removed at the same flow rate as the water removal rate (second flow rate) while removing excess water and waste from the patient, and the blood introduced in the blood removal process and The newly introduced blood is circulated in the blood circuit 110.

In the dialysis process, the blood circulating in the blood circuit 110 is gradually concentrated while being dialyzed without injecting a substituent into the blood circuit 110. This mainly removes small molecular weight substances such as urea. The dialysis process is performed while monitoring the hematocrit value by placing a blood concentration sensor near the blood outlet 122b of the blood purifier 120, and ends when the blood is concentrated until the hematocrit value reaches a predetermined value. . Then, the process moves to the next blood return process.

FIG. 20 shows the diafiltration step performed in the blood removal and circulation step. In the diafiltration process, the blood pump 111c is driven in the forward rotation direction at a gradually increasing speed until a predetermined flow rate (for example, 200 ml/min) is reached, and the substituent liquid pump 151 is driven at a third flow rate to supply a predetermined substituent liquid. The water removal/reverse filtration pump 1333 is driven at a speed Q _R (for example, 10 ml/min) plus the replacement liquid speed Q _R (third flow rate) (Q _R +10 ml/min). min). Further, in the dialysing fluid circuit 130, the dialysing fluid is led out from the dialysing fluid chamber 1331 (liquid feeding storage section 1331a) to the blood purifier 120 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 is introduced into the dialysate outlet line 132b at a predetermined flow rate, a second flow rate, and a third flow rate. A dialysate containing water from which water has been removed is delivered at a flow rate (for example, 400 + 10 + Q _R ml/mim).

In other words, while injecting the replacement fluid into the blood circuit 110 at a predetermined flow rate Q _R (third flow rate), the blood purifier 120 removes waste products and the second flow rate ( Water removal is performed at a flow rate equal to 10 ml/min) plus the replacement liquid injection amount Q _R (third flow rate). 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 process 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 hemoconcentration. The filtration flow rate can be increased. Therefore, the solute removal efficiency can be further improved.

In the diafiltration process, 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. In addition, similarly to the dialysis process, the blood circulating in the blood circuit 110 is gradually concentrated, and the diafiltration process is completed based on the blood concentration, elapsed time, amount of water removed (blood removal amount), etc., and then the next return is performed. Move on to the blood process.

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

(11) In the blood purification device 100C that performs blood removal and blood return alternately with one puncture needle SN, a replacement fluid bottle or a replacement fluid bag is used as the replacement fluid supply source 152C, and the blood circuit 110 is connected to the control device 140. A blood removal process in which blood is introduced at a first flow rate, and 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 process and the second flow rate are The blood removal and circulation process includes a blood removal and circulation process in which introduced blood is circulated through the blood circuit 110, and a blood return process in which a replacement fluid is injected into the blood circuit 110 and blood is drawn out from the blood circuit, and the blood removal and circulation process is performed repeatedly. A dialysis process is performed in which water is removed and dialyzed at the same flow rate as the second flow rate in the blood purifier 120, or a substituent liquid is injected into the blood circuit 110 via the substituent line 150 at a third flow rate, and the blood In the purifier 120, water was removed at a flow rate that was the sum of the second flow rate and the third flow rate, and at the same time, either one of the diafiltration steps was performed. Thereby, even in offline hemodiafiltration therapy, filtration can be performed with a large filtration flow rate.

100, 100A, 100B, 100C Blood purification device 110 Blood circuit 111 Arterial line 111c Blood pump 112 Venous line 120 Blood purifier 130 Dialysate circuit 133 Dialysate fluid feeding section 140 Control section 150 Substitute fluid line 151 Substitute fluid pump 152A , 152B, 152C Substitute fluid supply source 160 Filtrate line 161 Filtrate pump PS Venous pressure monitor SN Puncture needle

Claims (11)

A blood purification device that alternately removes blood and returns blood with a single puncture needle,
A blood purifier, a blood circuit, a replacement fluid supply source, a replacement fluid line connecting the blood circuit and the replacement fluid supply source, and a control unit,
The control unit includes:
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,
Repeating a treatment process including a blood return process of injecting a replacement fluid into the blood circuit and drawing blood from the blood circuit,
The blood removal circulation step may include a water removal step in which water is removed in the blood purifier at the same flow rate as the second flow rate, and/or a replacement fluid is introduced into the blood circuit via the replacement fluid line at a third flow rate. A blood purification device that performs any of the filtration steps in which water is injected and water is removed in the blood purifier at a flow rate that is the sum of the second flow rate and the third flow rate. A dialysate circuit is provided as the replacement fluid supply source, and a dialysate is used as the replacement fluid,
In the blood removal circulation step, the control unit includes:
As the water removal step, a dialysis step is performed in which water is removed at the same flow rate as the second flow rate in the blood purifier and dialyzed;
In the filtration step, a replacement fluid is injected into the blood circuit via the replacement fluid line at a third flow rate, and water is removed in the blood purifier at a flow rate equal to the third flow rate added to the second flow rate. The blood purification apparatus according to claim 1, which performs a diafiltration step in which dialysis is performed at the same time as dialysis. A dialysate circuit is provided as the replacement fluid supply source, and a dialysate is used as the replacement fluid,
The blood purification device according to claim 1, wherein the dialysate circuit is configured to prevent dialysate from flowing into the blood purifier. The blood purification device according to claim 1, wherein a substitution liquid bottle or a substitution liquid bag filled with a substitution liquid is used as the substitution liquid supply source. Using a replacement liquid bottle or a replacement liquid bag filled with the replacement liquid as the replacement liquid supply source,
Equipped with a dialysate circuit,
In the blood removal circulation step, the control unit includes:
As the water removal step, a dialysis step is performed in which water is removed at the same flow rate as the second flow rate in the blood purifier and dialyzed;
In the filtration step, a replacement fluid is injected into the blood circuit via the replacement fluid line at a third flow rate, and water is removed in the blood purifier at a flow rate equal to the third flow rate added to the second flow rate. The blood purification apparatus according to claim 1, which performs a diafiltration step in which dialysis is performed at the same time as dialysis. The control unit is configured to remove water in the blood purifier at the first flow rate in the blood removal step, and introduce blood into the blood circuit from both upstream and downstream sides of the blood purifier. Item 5. The blood purification device according to any one of Items 1 to 5. The blood purification device according to any one of claims 1 to 6, wherein the treatment step further includes a homogenization step of circulating and homogenizing the replacement fluid and blood in the blood circuit after the blood return step. 8. The control unit, in the homogenizing step, introduces blood into the blood circuit at the second flow rate and removes water in the blood purifier at the same flow rate as the second flow rate. blood purification device. The blood purification device according to any one of claims 1 to 6, wherein, in the blood return step, the control unit returns blood by causing a replacement fluid to flow into all of the blood circuits. The blood purification device according to any one of claims 1 to 9, wherein the control unit returns blood by injecting a substitution fluid into the blood circuit via the substitution fluid line in the blood return step. The control unit includes:
The blood purification device according to any one of claims 1 to 10, wherein the water removal step is performed in the blood removal and circulation step until the treatment step is repeated a predetermined number of times, and thereafter the filtration step is performed.

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