JP7532749B2 - Blood purification device and blood purification method - Google Patents

Description

The present invention relates to a blood purification device and a blood purification method.

Prior literature describing high sodium dialysis includes "Effects of high sodium dialysis on blood pressure, hematocrit, plasma osmolality and vasoactive substances" by Yagi, Noriko and 4 others, Journal of Dialysis Society 26(2), 1993, pp. 153-159 (Non-Patent Document 1). In the high sodium dialysis described in Non-Patent Document 1, a high concentration NaCl solution is injected into the standard dialysis fluid to increase the sodium concentration of the dialysis fluid, thereby suppressing a drop in blood pressure during dialysis.

Yagi, Noriko, and 4 others, "Effects of high sodium dialysis on blood pressure, hematocrit, plasma osmolality, and vasoactive substances," Journal of Dialysis Society 26(2), 1993, pp. 153-159

During high sodium dialysis, the sodium concentration in the dialysis patient's blood increases, which can cause the patient to become thirsty and consume too much water, resulting in high blood pressure.

The present invention was made in consideration of the above problems, and aims to provide a blood purification device and blood purification method that can stabilize the blood pressure of a dialysis patient during dialysis.

The blood purification device according to the present invention comprises a blood purifier, a supply line, a drain line, a dialysis fluid supply source, a chamber, and a Na concentration adjustment unit. The blood purifier is incorporated in a blood circuit in which blood flows from the upstream side to the downstream side. The supply line is a line for supplying dialysis fluid into the blood purifier. The drain line carries the drainage fluid discharged from the blood purifier. The dialysis fluid supply source supplies the dialysis fluid. The chamber is connected to the supply line and stores the dialysis fluid supplied from the dialysis fluid supply source. The Na concentration adjustment unit adjusts the Na concentration of the dialysis fluid. In the blood purification device, a replacement fluid is alternately performed by supplying the dialysis fluid stored in the chamber to the blood purifier through the fluid supply line at a first flow rate while discharging the waste fluid from the blood purifier through the fluid drain line at a second flow rate lower than the first flow rate, and a water removal is alternately performed by supplying the dialysis fluid stored in the chamber to the blood purifier through the fluid supply line at a third flow rate while discharging the waste fluid from the blood purifier through the fluid drain line at a fourth flow rate higher than the third flow rate. When replacement fluid is being performed, the Na concentration adjustment unit operates so that the dialysis fluid with a Na concentration higher than the minimum value of the Na concentration during the water removal is supplied to the blood purifier.

In one embodiment of the present invention, while water removal is being performed, the Na concentration of the dialysis fluid supplied to the blood purifier gradually decreases and then gradually increases.

In one embodiment of the present invention, the chamber is a viscous chamber. Each of the supply and drain lines is connected to the viscous chamber.

The blood purification method according to the present invention is a blood purification method performed in a blood purification device including a blood purifier incorporated in a blood circuit in which blood flows from the upstream side to the downstream side, a supply line for supplying dialysis fluid into the blood purifier, a drain line for flowing effluent discharged from the blood purifier, a dialysis fluid supply source for supplying the dialysis fluid, a chamber connected to the supply line for storing the dialysis fluid supplied from the dialysis fluid supply source, and a Na concentration adjustment unit for adjusting the Na concentration of the dialysis fluid. The blood purification method includes a fluid replacement step and a water removal step. In the fluid replacement step, the dialysis fluid stored in the chamber is supplied to the blood purifier through the supply line at a first flow rate, while the effluent is discharged from the blood purifier through the drain line at a second flow rate smaller than the first flow rate. In the water removal step, the dialysis fluid stored in the chamber is supplied to the blood purifier through the supply line at a third flow rate, while the effluent is discharged from the blood purifier through the drain line at a fourth flow rate larger than the third flow rate. The fluid replacement step and the water removal step are performed alternately. In the fluid replacement process, the Na concentration adjustment unit operates so that the dialysis fluid, whose Na concentration has been increased above the minimum Na concentration during the water removal process, is supplied to the blood purifier.

In one embodiment of the present invention, during the water removal process, the Na concentration of the dialysis fluid supplied to the blood purifier gradually decreases and then gradually increases.

The present invention makes it possible to stabilize the blood pressure of a dialysis patient during dialysis.

1 is a diagram showing the configuration of a blood purification apparatus according to one embodiment of the present invention. 3 is a time chart showing a blood purification method performed in the blood purification apparatus according to one embodiment of the present invention.

The blood purification device and blood purification method according to one embodiment of the present invention will be described below with reference to the drawings. In the following description of the embodiment, the same or corresponding parts in the drawings will be given the same reference numerals, and the description will not be repeated.

Figure 1 is a diagram showing the configuration of a blood purification device according to one embodiment of the present invention. As shown in Figure 1, the blood purification device 100 according to one embodiment of the present invention includes a blood purifier 110, a fluid supply line 171, a fluid drain line 172, a dialysis fluid supply source 150, a first chamber 131, a second chamber 132, and a Na concentration adjustment unit 160.

The first chamber 131 and the second chamber 132 are included in the water removal mechanism 130. In this embodiment, each of the first chamber 131 and the second chamber 132 is a viscous chamber. The viscous chamber includes a fresh dialysate chamber, a drain chamber, and a viscous chamber. The water removal mechanism 130 further includes a pump 133. The pump 133 is a viscous pump. The volumes of the fresh dialysate chamber and the drain chamber can be adjusted by pumping silicone oil into and out of the viscous chamber using the pump 133. Note that the configuration of the water removal mechanism 130 is not limited to a viscous control system.

The blood purifier 110 is incorporated into a blood circuit in which blood 1 flows from the upstream side to the downstream side. The blood purifier 110 is connected to an upstream blood pipeline 121 and a downstream blood pipeline 122, which are part of the blood circuit. The blood purifier 110 includes a semipermeable membrane therein, for example made of a hollow fiber membrane.

The supply line 171 is a line for supplying the dialysis fluid 5 into the blood purifier 110. The supply line 171 connects the blood purifier 110 and the water removal mechanism 130. Specifically, the supply line 171 connects the dialysis fluid inlet of the blood purifier 110 to the fresh dialysis fluid chambers of the first chamber 131 and the second chamber 132 of the water removal mechanism 130. In other words, the supply line 171 is connected to the viscous chamber.

Each of the first chamber 131 and the second chamber 132 has a first on-off valve, and when the first on-off valve of the first chamber 131 is open, the first on-off valve of the second chamber 132 is closed, and when the first on-off valve of the first chamber 131 is closed, the first on-off valve of the second chamber 132 is open. The supply line 171 is connected to the fresh dialysis fluid chamber in the first chamber 131 via the first on-off valve, and is connected to the fresh dialysis fluid chamber in the second chamber 132 via the first on-off valve. As a result, the supply line 171 alternately communicates with each of the fresh dialysis fluid chambers of the first chamber 131 and the second chamber 132.

The drainage pipe 172 carries the drainage liquid 7 discharged from the blood purifier 110. The drainage pipe 172 connects the blood purifier 110 to the water removal mechanism 130. Specifically, the drainage pipe 172 connects the drainage outlet of the blood purifier 110 to the drainage chambers of the first chamber 131 and the second chamber 132 of the water removal mechanism 130. In other words, the drainage pipe 172 is connected to the viscous chamber.

Each of the first chamber 131 and the second chamber 132 has a second on-off valve, and when the second on-off valve of the first chamber 131 is open, the second on-off valve of the second chamber 132 is closed, and when the second on-off valve of the first chamber 131 is closed, the second on-off valve of the second chamber 132 is open. The drain pipe 172 is connected to the drain chamber in the first chamber 131 via the second on-off valve, and is connected to the drain chamber in the second chamber 132 via the second on-off valve. This allows the drain pipe 172 to alternately communicate with each of the drain chambers of the first chamber 131 and the second chamber 132.

The dialysis fluid supply source 150 supplies the dialysis fluid 5 to the water removal mechanism 130. The dialysis fluid 5 is prepared by mixing the reverse osmosis water 2, the first stock solution 3, and the second stock solution 4 in the dialysis fluid supply source 150.

The first stock solution 3 is a liquid preparation prepared by dissolving a first powder containing at least one of, for example, calcium salt, magnesium salt, potassium salt, sodium salt, and glucose, which are part of the solute components of the dialysis fluid 5, in water. The first stock solution 3 is generated by the first powder dissolving device 141. Note that the first stock solution 3 may be stored in a first stock solution tank in a pre-generated state, instead of being generated by the first powder dissolving device 141.

The second stock solution 4 is a liquid preparation prepared by dissolving a second powder containing at least sodium bicarbonate, which is another part of the solute components of the dialysis fluid 5, in water. The second stock solution 4 is generated by the second powder dissolving device 142. Note that the second stock solution 4 may be stored in a second stock solution tank in a pre-generated state instead of being generated by the second powder dissolving device 142.

The dialysis fluid supply source 150 is connected to each of the first powder dissolving device 141 and the second powder dissolving device 142. The dialysis fluid supply source 150 is supplied with the first stock solution 3 from the first powder dissolving device 141. The dialysis fluid supply source 150 is supplied with the second stock solution 4 from the second powder dissolving device 142. When the first stock solution 3 is stored in the first stock solution tank, the first stock solution 3 is supplied from the first stock solution tank to the dialysis fluid supply source 150. When the second stock solution 4 is stored in the second stock solution tank, the second stock solution 4 is supplied from the second stock solution tank to the dialysis fluid supply source 150. The first chamber 131 and the second chamber 132 store the dialysis fluid 5 supplied from the dialysis fluid supply source 150.

The Na concentration adjustment unit 160 adjusts the Na concentration of the dialysis fluid 5. In this embodiment, the Na concentration adjustment unit 160 adds a NaCl solution 6 to the dialysis fluid 5 stored in the fresh dialysis fluid chambers of each of the first chamber 131 and the second chamber 132.

In addition, when the first stock solution 3 is stored in the first stock solution tank and the second stock solution 4 is stored in the second stock solution tank, the Na concentration adjustment unit 160 may be configured to add the NaCl solution 6 when preparing the dialysis solution 5 in the dialysis solution supply source 150. Alternatively, the Na concentration adjustment unit 160 may be configured with at least one of the first stock solution tank and the second stock solution tank. When the Na concentration adjustment unit 160 is configured with the first stock solution tank, the Na concentration of the dialysis solution 5 prepared in the dialysis solution supply source 150 can be adjusted by adjusting the amount of the first stock solution 3 supplied from the first stock solution tank. When the Na concentration adjustment unit 160 is configured with the second stock solution tank, the Na concentration of the dialysis solution 5 prepared in the dialysis solution supply source 150 can be adjusted by adjusting the amount of the second stock solution 4 supplied from the second stock solution tank.

Figure 2 is a time chart showing the blood purification method performed in a blood purification device according to one embodiment of the present invention. As shown in Figure 2, the blood purification device 100 alternates between a fluid replacement process and a water removal process. In other words, the blood purification device 100 performs intermittent infusion hemodiafiltration (I-HDF).

In the fluid replacement process, the dialysis fluid 5 stored in the chamber is supplied to the blood purifier 110 through the supply line 171 at a first flow rate, while the waste fluid is discharged from the blood purifier 110 through the drain line 172 at a second flow rate that is smaller than the first flow rate. In the water removal process, the dialysis fluid 5 stored in the chamber is supplied to the blood purifier 110 through the supply line 171 at a third flow rate, while the waste fluid is discharged from the blood purifier 110 through the drain line 172 at a fourth flow rate that is larger than the third flow rate.

Specifically, when the pump 133 is driven in the forward direction, the silicone oil moves from the viscous chamber of the first chamber 131 to the viscous chamber of the second chamber 132. This generates a negative pressure in each of the fresh dialysate chamber and the drain chamber of the first chamber 131. On the other hand, a positive pressure is generated in each of the fresh dialysate chamber and the drain chamber of the second chamber 132.

As a result, the dialysis fluid 5 supplied from the dialysis fluid supply source 150 flows into the fresh dialysis fluid chamber of the first chamber 131, and the effluent 7 discharged from the blood purifier 110 flows into the drain chamber of the first chamber 131 through the drain pipe 172 at a second flow rate. The dialysis fluid 5 flows from the fresh dialysis fluid chamber of the second chamber 132 into the blood purifier 110 through the supply pipe 171 at a first flow rate, and the effluent 7 is discharged from the drain chamber of the second chamber 132 to the outside of the water removal mechanism 130. This performs the fluid replacement process. For example, the first flow rate is 500 mL/min, and the second flow rate is 350 mL/min. In this case, the fluid replacement speed is 150 mL/min.

Next, the pump 133 is driven in the reverse direction, causing the silicone oil to move from the viscous chamber of the second chamber 132 to the viscous chamber of the first chamber 131. This creates a negative pressure in the fresh dialysate chamber and the drain chamber of the second chamber 132. Meanwhile, a positive pressure is created in the fresh dialysate chamber and the drain chamber of the first chamber 131.

As a result, the dialysis fluid 5 supplied from the dialysis fluid supply source 150 flows into the fresh dialysis fluid chamber of the second chamber 132, and the waste fluid 7 discharged from the blood purifier 110 flows into the drain chamber of the second chamber 132 through the drain pipe 172 at a fourth flow rate. The dialysis fluid 5 flows from the fresh dialysis fluid chamber of the first chamber 131 into the blood purifier 110 through the supply pipe 171 at a third flow rate, and the waste fluid 7 is discharged from the drain chamber of the first chamber 131 to the outside of the water removal mechanism 130. This performs the water removal process. For example, the third flow rate is 500 mL/min, and the fourth flow rate is 517 mL/min. In this case, the water removal speed is 1.0 L/hr.

The pump 133 alternates between the forward and reverse rotations described above. In other words, the fluid replacement process and the water removal process are alternately repeated. As shown in FIG. 2, the fluid replacement process is performed, for example, once every 30 minutes. The duration of one fluid replacement process is, for example, one minute.

In the blood purification device 100, when the fluid replacement process is being performed, the Na concentration adjustment unit 160 operates so that the dialysis fluid 5, whose Na concentration has been increased above the minimum Na concentration during the water removal process, is supplied to the blood purifier 110.

As shown in FIG. 2, the minimum Na concentration supplied to the blood purifier 110 during the water removal process is, for example, 140 mEq/L. The minimum Na concentration supplied to the blood purifier 110 during the fluid replacement process is, for example, 143 mEq/L.

In this embodiment, in the water removal process, the Na concentration of the dialysis fluid 5 supplied to the blood purifier 110 gradually decreases and then gradually increases. As shown in FIG. 2, in the water removal process, immediately after the fluid replacement process, the Na concentration gradually decreases from 143 mEq/L to 140 mEq/L, and after the Na concentration is maintained at 140 mEq/L for a certain period of time, the Na concentration gradually increases to 143 mEq/L, and the process switches to the fluid replacement process. The transition of the Na concentration is not limited to the above, and any transition may be made such that, during the fluid replacement process, the dialysis fluid 5 with a Na concentration higher than the minimum value of the Na concentration during the water removal process is supplied to the blood purifier 110.

The dialysis fluid with a high Na concentration may be supplied to the blood purifier 110 during the fluid replacement process only for a portion of the time during the dialysis treatment. In this case, during the first half of the dialysis treatment, the blood purifier 110 is supplied with dialysis fluid that does not have a high Na concentration even during the fluid replacement process.

In the blood purification device 100 according to one embodiment of the present invention, the following operations are alternately performed: replacement fluid, in which the dialysis fluid 5 stored in the chamber is supplied to the blood purifier 110 through the supply fluid line 171 at a first flow rate while the effluent is discharged from the blood purifier 110 through the drainage fluid line 172 at a second flow rate less than the first flow rate; and water removal, in which the dialysis fluid 5 stored in the chamber is supplied to the blood purifier 110 through the supply fluid line 171 at a third flow rate while the effluent is discharged from the blood purifier 110 through the drainage fluid line 172 at a fourth flow rate greater than the third flow rate. During replacement fluid, the Na concentration adjustment unit 160 operates so that the blood purifier 110 is supplied with a dialysis fluid 5 having a higher Na concentration than the minimum Na concentration during the water removal.

This allows replacement fluid to be provided using dialysis fluid with a high Na concentration, preventing a drop in the dialysis patient's blood pressure. It also prevents the Na concentration in the dialysis fluid from increasing while water removal is being performed, reducing the thirst of the dialysis patient and preventing the dialysis patient from ingesting too much water and developing high blood pressure. This in turn stabilizes the blood pressure of the dialysis patient during dialysis.

In the blood purification device 100 according to one embodiment of the present invention, while water removal is being performed, the Na concentration of the dialysis fluid 5 supplied to the blood purifier 110 gradually decreases and then gradually increases. This prevents the Na concentration in the blood of the dialysis patient from becoming too low due to the removal of Na from the blood 1 by the blood purifier 110 after water removal begins, stabilizing the effect of suppressing a drop in blood pressure.

In the blood purification device 100 according to one embodiment of the present invention, the chamber is a viscous chamber, and the supply line and the drain line are each connected to the viscous chamber. This prevents the pump 133 from coming into direct contact with the dialysis fluid 5 and the drain 7, ensuring the reliability and durability of the water removal mechanism 130.

The above disclosed embodiments are illustrative in all respects and are not intended to be a basis for restrictive interpretation. Therefore, the technical scope of the present invention is not interpreted solely by the above described embodiments, but is defined based on the claims. Furthermore, all modifications within the scope and meaning equivalent to the claims are included.

1 Blood, 2 Reverse osmosis water, 3 First stock solution, 4 Second stock solution, 5 Dialysis fluid, 6 NaCl solution, 7 Drainage fluid, 26 Dialysis journal, 100 Blood purification device, 110 Blood purifier, 121 Upstream blood line, 122 Downstream blood line, 130 Water removal mechanism, 131 First chamber, 132 Second chamber, 133 Pump, 141 First powder dissolving device, 142 Second powder dissolving device, 150 Dialysis fluid supply source, 160 Na concentration adjustment unit, 171 Supply line, 172 Drainage line.

Claims (5)

A blood purifier incorporated in a blood circuit through which blood flows from the upstream side to the downstream side;
a supply line for supplying a dialysis fluid into the blood purifier;
a drainage pipe through which the drainage liquid discharged from the blood purifier flows;
a dialysate source for supplying the dialysate;
a chamber connected to the supply line and configured to store the dialysis fluid supplied from the dialysis fluid supply source;
A Na concentration adjusting unit that adjusts the Na concentration of the dialysis fluid,
a fluid replacement step in which the dialysis fluid stored in the chamber is supplied to the blood purifier through the fluid supply line at a first flow rate while the drainage fluid is discharged from the blood purifier through the fluid drain line at a second flow rate lower than the first flow rate, and a water removal step in which the dialysis fluid stored in the chamber is supplied to the blood purifier through the fluid supply line at a third flow rate while the drainage fluid is discharged from the blood purifier through the fluid drain line at a fourth flow rate higher than the third flow rate are alternately and repeatedly performed at a constant cycle;
A blood purification device in which, when the fluid replacement is being performed, the Na concentration adjustment unit operates so that the dialysis fluid supplied to the blood purifier has a Na concentration higher than the minimum Na concentration of the dialysis fluid supplied to the blood purifier while the water removal is being performed. The blood purification device according to claim 1, wherein the Na concentration of the dialysis fluid supplied to the blood purifier gradually decreases and then gradually increases while the water removal is being performed. the chamber being a viscous chamber;
3. The blood purification apparatus according to claim 1, wherein each of the liquid supply line and the liquid drain line is connected to the viscous chamber. A blood purifier incorporated in a blood circuit through which blood flows from the upstream side to the downstream side;
a supply line for supplying a dialysis fluid into the blood purifier;
a drainage pipe through which the drainage liquid discharged from the blood purifier flows;
a dialysate source for supplying the dialysate;
a chamber connected to the supply line and configured to store the dialysis fluid supplied from the dialysis fluid supply source;
and a Na concentration adjusting unit for adjusting the Na concentration of the dialysis fluid,
The blood purification device comprises:
a fluid replacement step of supplying the dialysis fluid stored in the chamber to the blood purifier through the fluid supply line at a first flow rate while discharging the drained fluid from the blood purifier through the drain line at a second flow rate lower than the first flow rate;
a water removal step of supplying the dialysis fluid stored in the chamber to the blood purifier through the supply line at a third flow rate while discharging the drained fluid from the blood purifier through the drain line at a fourth flow rate greater than the third flow rate, and
A method for operating a blood purification device, in which, during the fluid replacement process, the Na concentration adjustment unit operates so that the dialysis fluid supplied to the blood purifier has a Na concentration higher than the minimum Na concentration of the dialysis fluid supplied to the blood purifier while the water removal process is being performed. The method for operating a blood purification device according to claim 4, wherein, in the water removal process, the Na concentration of the dialysis fluid supplied to the blood purifier gradually decreases and then gradually increases.

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