JP2021073030A - Blood purification device - Google Patents

Abstract

To provide a blood purification device capable of immediately supplying dialysis fluid in a dialysis introduction line to a blood circuit in the middle of an ultrafiltration treatment without performing a preparatory operation for fluid replenishment, or immediately supplying dialysis fluid in the dialysis introduction line to the blood circuit after the ultrafiltration treatment for returning blood.SOLUTION: A blood purification device includes a dialyzer 1 for purifying blood flowing in a blood circuit, a dialysis fluid introduction line L1 capable of introducing dialysis fluid to the dialyzer 1, a dialysis fluid discharge line L2 capable of discharging waste fluid from the dialyzer 1, and a water removal pump 10 capable of removing water from the blood flowing in the blood circuit, and can supply dialysis fluid in the dialysis fluid introduction line L1 to the blood circuit for performing fluid replenishment or blood returning. When an ultrafiltration treatment in which, while introduction of dialysis fluid to the dialyzer 1 is stopped, the water removal pump 10 is driven for removing water, is carried out, supply of dialysis fluid is performed while inflow of dialysis fluid to the dialyzer 1 is regulated.SELECTED DRAWING: Figure 4

Description

The present invention relates to a blood purification device capable of replenishing or returning blood by supplying dialysate from a dialysate introduction line to a blood circuit.

As a blood purification treatment that purifies a patient's blood while circulating it extracorporeally, for example, as disclosed in Patent Document 1, "ECUM" (extracorporeal ultrafiltration method) that only removes water without flowing dialysate through a dialyzer. There is a treatment method called. According to this "ECUM" (hereinafter, referred to as "extreme filtration treatment"), diffusion by a dialyzer is not performed and removal of solutes in blood is avoided, so that a decrease in blood pressure can be suppressed.

When performing such ultrafiltration treatment with a blood purification device, the water removal pump is usually used without introducing the dialysate into the dialyzer by closing the dialysate introduction line that introduces the dialysate into the dialyzer with an electromagnetic valve or the like. By driving, only water is removed from the blood circulating outside the body in the blood circuit by utilizing the action of ultrafiltration in the dialyzer.

JP-A-2007-236924

However, when the above-mentioned ultrafiltration treatment is performed in a blood purification device capable of replenishing fluid (emergency replenishing fluid) or returning blood by supplying the dialysate from the dialysate introduction line to the blood circuit, there are the following problems.
That is, during the ultrafiltration treatment, the liquid feeding means (double pump, etc.) for sending the liquid to the dialyzer is stopped, the dialysate in the dialysate introduction line stays, and the dialysate sent to the dialyzer is discharged. The heating means such as a heater for heating is also stopped.

Therefore, if ultrafiltration treatment is performed for a long time, the composition and concentration of the dialysate retained in the dialysate introduction line may change, or the temperature of the dialysate may drop to about room temperature. Supplying the dialysate in the state to the blood circuit may cause problems. Therefore, when emergency fluid replacement is performed during the ultrafiltration treatment or when blood is returned after the ultrafiltration treatment, the dialysate is flowed by the liquid feeding means to eliminate the retention and the heating means is activated. A preparatory operation is required to heat the dialysate supplied to the blood circuit, and there is a problem that emergency fluid replacement and blood return cannot be performed during the preparatory operation.

The present invention has been made in view of such circumstances, and the dialysate of the dialysate introduction line is immediately supplied to the blood circuit to supplement the fluid during the ultrafiltration treatment without going through the preparatory operation. It is an object of the present invention to provide a blood purification device capable of immediately supplying dialysate from a dialysate introduction line to a blood circuit to return blood after ultrafiltration treatment.

The invention according to claim 1 is connected between a blood circuit having an arterial blood circuit and a venous blood circuit capable of extracorporeally circulating a patient's blood, and the arterial blood circuit and the venous blood circuit, and the blood. A blood purification means for purifying blood flowing through a circuit, a dialysate introduction line capable of introducing dialysate into the blood purification means, a dialysate discharge line capable of discharging drainage from the blood purification means, and the blood purification It is provided with a water removal pump capable of removing water from the blood flowing through the blood circuit via means, and the dialysate of the dialysate introduction line is supplied to the blood circuit to purify the blood so that it can be replenished or returned. It is an apparatus that regulates the inflow of dialysate into the blood purification means when the extrafiltration treatment is performed in which the water removal pump is driven to remove water while stopping the introduction of the dialysate into the blood purification means. It is characterized in that the dialysate is fed while the dialysate is sent.

The invention according to claim 2 is the blood purification apparatus according to claim 1, wherein the dialysate of the dialysate introduction line can be fed to the blood purification means, and the blood purification means is bypassed. A bypass line capable of allowing the dialysate of the dialysate introduction line to flow to the dialysate discharge line, and a closing means capable of closing the flow path between the connection portion of the bypass line and the blood purification means in the dialysate introduction line. At the time of the ultrafiltration treatment, the flow path is closed by the closing means and the dialysate sent by the liquid feeding means is allowed to flow in the bypass line.

The invention according to claim 3 is characterized in that, in the blood purification apparatus according to claim 1 or 2, the dialysate is sent at a preset timing during the ultrafiltration treatment. ..

According to the fourth aspect of the present invention, in the blood purification apparatus according to the third aspect, the preset timing is determined at a time based on the start time or the end time of the ultrafiltration treatment or a change time of the treatment conditions. It is characterized by that.

The invention according to claim 5 is the blood purification apparatus according to claim 3, wherein the preset timing is determined based on a parameter relating to a patient's condition or a treatment condition detected during the ultrafiltration treatment. It is characterized by that.

The invention according to claim 6 includes the detection means capable of detecting the temperature or concentration of the dialysate in the dialysate introduction line in the blood purification apparatus according to claim 3, and the preset timing is the same. It is characterized in that it is determined based on the temperature or concentration detected by the detection means during the ultrafiltration treatment.

The invention according to claim 7 is provided with a heating means capable of heating the dialysate in the blood purification apparatus according to any one of claims 1 to 6, and at the time of the ultrafiltration treatment, the dialysate. The dialysate is heated by the heating means while the liquid is being sent.

According to the invention of claim 1, when the extrafiltration treatment in which the water removal pump is driven to remove water while stopping the introduction of the dialysate into the blood purification means is performed, the inflow of the dialysate into the blood purification means is regulated. Since the dialysate is sent while the dialysate is sent, the dialysate from the dialysate introduction line is immediately supplied to the blood circuit during the ultrafiltration treatment without going through the preparatory operation to supplement the fluid, or the ultrafiltration treatment. After that, the dialysate from the dialysate introduction line can be immediately supplied to the blood circuit to return blood.

According to the invention of claim 2, at the time of the ultrafiltration treatment, the flow path is closed by the closing means and the dialysate sent by the liquid feeding means is flowed by the bypass line, so that the dialysate is sent by the liquid feeding means. The inflow of the dialysate into the blood purification means can be regulated while the liquid dialysate is allowed to flow through the bypass line.

According to the invention of claim 3, since the dialysate is sent at a preset timing during the ultrafiltration treatment, the dialysate is sent at all times of the ultrafiltration treatment. In comparison, the consumption of dialysate can be reduced and the cost can be reduced.

According to the invention of claim 4, the preset timing is determined at the time based on the start time or the end time of the ultrafiltration treatment or the time when the treatment conditions are changed, and therefore an appropriate timing at the time of the ultrafiltration treatment. The dialysate can be sent at.

According to the invention of claim 5, the preset timing is determined based on the parameters related to the patient's condition or the treatment condition detected during the ultrafiltration treatment, and thus depends on the patient's condition or the treatment condition. The dialysate can be sent at an appropriate timing.

According to the invention of claim 6, since the preset timing is determined based on the temperature or concentration detected by the detection means during the ultrafiltration treatment, it is appropriate according to the temperature or concentration of the dialysate. The dialysate can be sent at the timing.

According to the invention of claim 7, during the ultrafiltration treatment, the dialysate is heated by the heating means while the dialysate is being sent, so that the replacement solution or the ultrafiltration treatment during the ultrafiltration treatment is performed. The dialysate supplied to the blood circuit in the subsequent blood return can be brought to an appropriate temperature.

Schematic diagram showing a blood purification apparatus according to the first embodiment of the present invention. Flow chart showing the control contents during treatment in the hemodialysis machine Schematic diagram showing the state of the hemodialysis machine during ultrafiltration treatment (without liquid delivery) Schematic diagram showing the state of the hemodialysis machine during ultrafiltration treatment (with liquid delivery) Schematic diagram showing the state of the hemodialysis machine at the time of emergency fluid replacement or blood return Schematic diagram showing the state of the hemodialysis machine at the time of other ultrafiltration treatment (with liquid delivery) A flowchart showing the control contents at the time of treatment in the hemodialysis apparatus according to the second embodiment of the present invention.

Hereinafter, embodiments of the present invention will be specifically described with reference to the drawings.
The blood purification device according to the first embodiment is applied to a hemodialysis device, and as shown in FIG. 1, a dialyzer 1 as a blood purification means has an arterial blood circuit 2 and a venous blood circuit 3. Mainly from a dialyzer main body B having a connected blood circuit, a double pump 7, a water removal pump 10, a dialysate introduction line L1 and a dialysate discharge line L2, a dialysate supply line La, and a control means 21. It is configured.

The dialyzer 1 contains a blood purification membrane (not shown in the present embodiment, which is a hollow thread type hemodialysis membrane or a hemodialysis filtration membrane, but includes a flat membrane type hemodialysis membrane) to introduce blood. A blood introduction port 1a and a blood outlet 1b for drawing out the introduced blood are formed, and a dialysate introduction port 1c for introducing the dialysate and a dialysate discharge port 1d for discharging the introduced dialysate are formed. , The dialysate is brought into contact with the blood introduced from the blood introduction port 1a via a hollow thread film to purify the blood.

The arterial blood circuit 2 is mainly composed of a flexible tube, one end of which is connected to the blood inlet 1a of the dialyzer 1 to guide blood collected from a patient's blood vessel into the hollow fiber membrane of the dialyzer 1. A connector a to which the arterial puncture needle c can be attached is formed at the other end of the arterial blood circuit 2, an arterial air trap chamber 5 for defoaming is connected in the middle, and a blood pump. 4 is arranged. The blood pump 4 is an ironing type pump (a structure that squeezes a flexible tube when rotated in the normal direction to allow blood to flow from the arterial side puncture needle c side toward the blood introduction port 1a of the dialyzer 1). is there.

Like the arterial blood circuit 2, the venous blood circuit 3 is mainly composed of a flexible tube, one end of which is connected to the blood outlet 1b of the dialyzer 1 to draw out blood that has passed through the hollow fiber membrane. is there. A connector b to which the venous puncture needle d can be attached is formed at the other end of the venous blood circuit 3, and a venous air trap chamber 6 for defoaming is connected in the middle. That is, the blood of the patient collected by the arterial puncture needle c reaches the dialyzer 1 via the arterial blood circuit 2, and after the blood is purified, flows through the venous blood circuit 3 and the venous puncture needle d. It is designed to return to the patient's body via the blood vessel, which is configured to provide extracorporeal circulation. In the present specification, the side of the puncture needle for removing blood (collecting blood) is referred to as "arterial side", and the side of the puncture needle for returning blood is referred to as "venous side", and the "arterial side" and "Venous side" does not mean that the blood vessel to be punctured is defined by either an artery or a vein.

A bubble detection sensor 16 is attached between the clamping means Vb in the venous blood circuit 3 and the venous air trap chamber 6. The bubble detection sensor 16 is composed of a sensor capable of detecting bubbles (air) in a liquid flowing through a blood circuit, and includes, for example, a pair of ultrasonic vibration elements (oscillation means and receiving means) made of a piezoelectric element. Has been done.

A clamping means Va that can open and close the flow path is connected to the tip side of the arterial blood circuit 2 (between the connector a and the blood pump 4 and in the vicinity of the connector a), and the venous blood circuit 3 A clamping means Vb capable of opening and closing the flow path is connected to the tip side (between the connector b and the vein side air trap chamber 6 and in the vicinity of the connector b). Further, an overflow line Lb extends from the upper part of the venous side air trap chamber 6 formed in the middle of the venous side blood circuit 3, and a clamping means capable of opening and closing the flow path in the middle of the overflow line Lb. Vd is connected.

Therefore, before the dialysis treatment, by connecting the connector a and the connector b, the tip of the arterial blood circuit 2 and the tip of the venous blood circuit 3 are connected, and the arterial blood circuit 2 and the venous side are connected. A closed circuit on the blood circuit side can be formed in the blood circuit 3 (including the blood flow path through which blood flows in the dialyzer 1). Then, by supplying the dialysate as the priming solution into the closed circuit via the dialysate supply line La, the blood circuits (arterial side blood circuit 2 and vein side blood circuit 3) are filled with the dialysate. It is possible to perform priming work. In the process of priming work, the dialysate can be overflowed from the overflow line Lb to clean the inside of the closed circuit on the blood circuit side.

Further, in the venous air trap chamber 6, the pressure of the air layer formed on the upper side is detected during extracorporeal circulation of blood by the blood circuit, and the hydraulic pressure (venous pressure) in the venous blood circuit 3 is detected. The venous pressure sensor 13 to obtain is attached. Then, when the blood purification treatment is started and the patient's blood is circulated extracorporeally in the blood circuit, the venous pressure detected by the venous pressure sensor 13 can be monitored.

The ends of the dialysate introduction line L1 and the dialysate discharge line L2 are connected to the dialysate introduction port 1c and the dialysate discharge port 1d of the dialyzer 1, respectively, and are connected to the dialyzer 1 via the dialysate introduction line L1. The introduced dialysate is configured to pass outside the hollow fiber membrane and be discharged from the dialysate discharge line L2. As described above, the inside of the hollow fiber membrane (purifying membrane) in the dialyzer 1 forms a blood flow path through which blood can flow, and the outside of the hollow fiber membrane forms a dialysate flow path through which dialysate can flow. It is supposed to be.

The dialysing apparatus main body B has a dialysate introduction line L1 and a dialysate discharge line L2, and also has a double pump 7, bypass lines L3 to L6, and solenoid valves V1 to V9. Of these, the dual pump 7 is arranged across the dialysate introduction line L1 and the dialysate discharge line L2, and introduces the dialysate prepared to a predetermined concentration into the dialyzer 1 and the dialysate after dialysation from the dialyzer 1. Is to be discharged. That is, the dual pump 7 according to the present embodiment constitutes a "liquid feeding means" capable of feeding the dialysate of the dialysate introduction line L1 to the dialyzer 1 by driving. Instead of the compound pump 7, another form of liquid feeding means (including not only the pump but also a balance chamber and the like) capable of feeding the dialysate of the dialysate introduction line L1 to the dialyzer 1 may be used.

A solenoid valve V1 is connected in the middle of the dialysate introduction line L1 (downstream side (dialyzer 1 side) from the connection portion with the dialysate supply line La in the dialysate introduction line L1), and the dialysate discharge line L2. A solenoid valve V2 is connected on the way (on the upstream side (dialyzer 1 side) of the connection portion with the bypass line L3 in the dialysate discharge line L2). Of these, the solenoid valve V1 constitutes a "closing means" capable of closing the flow path between the connection portion of the bypass line (bypass line L3 or L4) described later and the dialyzer 1 in the dialysate introduction line L1. ..

Further, the dialysate introduction line L1 includes a heater 17 (heating means) capable of heating the dialysate sent by the double pump 7 (liquid delivery means) and the concentration of the dialysate in the dialysate introduction line L1. The concentration sensor 18 (detecting means) capable of detecting the above is connected to the temperature sensors 19 and 20 (detecting means) capable of detecting the temperature of the dialysate in the dialysate introduction line L1. Of these, the heater 17, the concentration sensor 18, and the temperature sensor 19 are arranged on the upstream side of the arrangement position of the double pump 7, and the temperature sensor 20 is arranged on the downstream side of the arrangement position of the double pump 7. ing. The solenoid valve V8 is connected to the upstream side of the heater 17 in the dialysate introduction line L1, and the solenoid valve V9 is connected to the dialysate discharge line L2 (downstream from the connection portion with the bypass line L6). Has been done.

Further, filtration filters 8 and 9 are connected between the double pump 7 and the solenoid valve V1 in the dialysate introduction line L1. The filtration filters 8 and 9 are for filtering and purifying the dialysate flowing through the dialysate introduction line L1, and the filtration filters 8 and 9 bypass the dialysate discharge line L2 to guide the dialysate. Bypass lines L3 and L4 for dialysis are connected respectively.

Solenoid valves V3 and V4 are connected to these bypass lines L3 and L4, respectively. By opening the flow path with the solenoid valve V3 or solenoid valve V4 open, the dialyzer 1 is bypassed and the dialysate introduction line L1 The dialysate is configured to be able to flow to the dialysate discharge line L2. A solenoid valve V6 is connected between the filtration filter 8 and the filtration filter 9 in the dialysate introduction line L1.

On the other hand, a hydraulic pressure measuring sensor 12 capable of measuring the hydraulic pressure of the dialysate is attached between the connecting portion with the bypass line L3 and the connecting portion with the bypass line L4 in the dialysate discharge line L2. Further, bypass lines L5 and L6 that bypass the drainage side of the dual pump 7 are connected to the dialysate drainage line L2, respectively, and the bypass line L5 removes water from the patient's blood flowing through the dialyzer 1. A water removal pump 10 is provided for this purpose, and a solenoid valve V5 capable of opening and closing the flow path is connected to the bypass line L6.

Further, on the upstream side of the double pump 7 in the dialysate discharge line L2 (between the connecting portion with the bypass line L5 and the double pump 7), pressurization for adjusting the hydraulic pressure on the drainage side of the double pump 7 is performed. A pump 14 is arranged. Further, a degassing chamber 15 is connected to the upstream side (between the pressurizing pump 14 and the double pump 7) of the dialysate discharge line L2 from the double pump 7, and a check valve or the like is connected to the degassing chamber 15. An open-air line L7 is connected to the open-air line L7, and a solenoid valve V7 is connected to the open-air line L7.

One end of the dialysate supply line La is connected to a collection port 11 (so-called sampling port) formed in the dialysate introduction line L1, and the other end is an arterial blood circuit 2 (or a venous blood circuit 3). It is connected to (may be) and consists of a flow path capable of supplying the dialysate of the dialysate introduction line L1 to the arterial blood circuit 2 (or the intravenous blood circuit 3). The dialysate supply line La is provided with a clamping means Vc capable of opening and closing the flow path, and by opening the clamping means Vc, the blood circuit is dialyzed via the dialysate supply line La. A fluid can be supplied to allow pre-treatment priming, intra-treatment replacement fluid (emergency replacement fluid), or post-treatment blood return.

The control means 21 is composed of, for example, a microcomputer or the like arranged in the dialysis apparatus main body B, and opens and closes arbitrary electromagnetic valves V1 to V9, opens and closes arbitrary clamps (Va to Vd), a double pump 7 and a blood pump. It is possible to control the drive or stop of an arbitrary actuator such as 4, the operation of the heater 17 (heating means), the hydraulic pressure measurement sensor 12, the venous pressure sensor 13, the bubble detection sensor 16, and the concentration sensor 18 (detection means). , Temperature sensors 19, 20 (detecting means) and other sensors are electrically connected. The dialysate discharge line L2 may be provided with a drainage concentration sensor capable of detecting the concentration of drainage, a blood pressure sensor capable of detecting the blood pressure of the patient undergoing treatment, and the like, and the detection value by these sensors may be monitored.

Further, in the present embodiment, the dialysate of the dialysate introduction line L1 is supplied to the blood circuit so that the replacement fluid during treatment (emergency replacement fluid) and the blood can be returned after the treatment. Emergency replacement fluid is a step of supplying dialysate as a replacement fluid to the blood circuit when the patient's blood pressure drops excessively during treatment, and blood return is a dialysate as a replacement fluid after treatment. Is a process of supplying blood to the blood circuit and returning the blood remaining in the blood circuit to the patient.

Further, the control means 21 is configured to perform ultrafiltration treatment (“ECUM” operation) in which the water removal pump 10 is driven to remove water while stopping the introduction of the dialysate into the dialyzer 1. Specifically, as shown in FIGS. 3 and 4, the blood pump 4 is driven to drive the water removal pump 10 while circulating blood extracorporeally in the blood circuit, and the hollow fiber of the dialyzer 1 is driven by the action of ultrafiltration. Ultrafiltration treatment is performed by removing water from the blood flowing through the membrane and discharging it through the dialysate discharge line L2. As a result, only water removal can be performed without diffusion in the dialyzer 1, so that a decrease in plasma osmotic pressure due to removal of substances in blood (urea or creatinine) due to diffusion can be suppressed.

Here, as shown in FIG. 4, the control means 21 according to the present embodiment performs dialysis by the dual pump 7 (liquid feeding means) while restricting the inflow of the dialysate into the dialyzer 1 when the ultrafiltration treatment is performed. It is possible to control the liquid to be sent. Specifically, as described above, only water removal is performed without diffusion by the dialyzer 1, and as shown in the figure, the solenoid valve V1 (closing means) is closed and the solenoid valve V3 is open. As a result, the flow path to the dialyzer 1 is closed, and the dialysate fed by the double pump 7 (liquid feeding means) is configured to flow along the bypass line L3.

Therefore, even during the ultrafiltration treatment, the dialysate of the dialysate introduction line L1 can be allowed to flow to the dialysate discharge line L2 via the bypass line L3 and flow out from there, so that the dialysate can be dialyzed. It is possible to prevent the dialysate from staying on the liquid introduction line L1 and to prevent the dialysate from dropping due to heating by the heater 17. Therefore, the dialysate of the dialysate introduction line L1 is immediately supplied to the blood circuit during the ultrafiltration treatment to supplement the blood circuit, or the dialysate of the dialysate introduction line L1 is immediately supplied to the blood circuit after the ultrafiltration treatment. And blood can be returned.

In particular, in the present embodiment, the dialysate is fed by the dual pump 7 (liquid feeding means) at the time of the ultrafiltration treatment is controlled so as to be performed at a preset timing. That is, when the ultrafiltration treatment is performed, as shown in FIG. 3, the double pump 7 is stopped to stop the flow of the dialysate in the dialysate introduction line L1 and the blood pump 4 is driven to enter the blood circuit. The blood removal pump 10 is driven while circulating blood outside the body, and only water removal is performed without diffusion by the dialyzer 1. At a preset timing, the blood pump 4 and removal are performed as shown in FIG. The compound pump 7 is driven while maintaining the drive of the water pump 10, and the dialysate of the dialysate introduction line L1 is configured to flow to the dialysate discharge line L2 via the bypass line L3.

The preset timing (the drive timing of the dual pump 7 during the ultrafiltration treatment) can be determined by the time based on the start or end time of the ultrafiltration treatment or the time when the treatment conditions are changed, for example, the start of treatment. It may be a fixed time period from the start of the treatment to the end of the treatment, a predetermined time after the start of the treatment, a predetermined time before the end of the treatment, or a time zone in which a decrease in blood pressure is estimated for each patient from the past treatment results. In addition, during ultrafiltration treatment, if it is detected that the water removal rate setting value or blood flow rate setting value has been lowered (change in treatment conditions) based on the judgment of medical staff, etc., the change is made. As a trigger, the dialysate may be fed by the dual pump 7 (liquid feeding means).

In addition, preset timing can be determined based on parameters relating to the patient's condition or treatment condition detected during ultrafiltration therapy, such as the patient's blood pressure value detected or calculated during treatment. It may be a hematocrit value, ΔBV (rate of change in circulating blood volume), PRR (plasma refill rate), various parameters detected by DDM (dialysis amount monitor), and the like. For the blood pressure value, it is preferable to use a sphygmomanometer provided with a blood purification device, it is preferable to wear a cuff of the sphygmomanometer to continuously detect the blood pressure of the patient at predetermined time intervals, and the hematocrit value is set in the blood circuit. It is preferable to detect with the arranged hematocrit sensor.

ΔBV (rate of change in circulating blood volume) is calculated based on the hematocrit value (which may be hemoglobinometry, serum total protein concentration, etc.) detected during treatment, and is the amount of blood in the blood vessel of the patient. It is an indicator of change. In addition, PRR (plasma refilling rate) is an index indicating the margin of replenishment (plasma refilling) of extravascular interstitial fluid with blood due to water removal. Since the decrease in ΔBV and PRR is a guideline for the decrease in blood pressure, it can be estimated that fluid replacement is performed when the value becomes less than a predetermined value. Since there are individual differences in the decrease in ΔBV and PRR, it is preferable to set them arbitrarily according to the patient.

The DDM (dialysis amount monitor) is arranged, for example, on the dialysate discharge line L2, and by measuring the change in ultraviolet absorbance of the dialysate drainage, the change in blood urea nitrogen that correlates with the change in absorbance is calculated, and Kt. It is a monitor that can calculate parameters such as / V (standardized dialysis dose) and URR (urea removal rate). Since these increases in Kt / V (standardized dialysis dose) and URR (urea removal rate) are indicators of the progress of treatment (treatment status), ultrafiltration treatment is performed on condition that the predetermined threshold is exceeded. The timing may be set to drive the compound pump 7 at times.

Furthermore, the preset timing can be determined based on the temperature or concentration detected by the concentration sensor 18 or the temperature sensor (19, 20) (detection means) during the ultrafiltration treatment. For example, during ultrafiltration treatment, when the concentration or temperature of the dialysate detected by the concentration sensor 18 or the temperature sensor (19, 20) is equal to or less than a predetermined value, the heater 17 is operated and the compound pump 7 is driven. If the dialysate of the dialysate introduction line L1 is allowed to flow to the dialysate discharge line L2 via the bypass line L3, the dialysate can be immediately supplied to the blood circuit at the time of replenishment or blood return.

The preset timings are dialyzer differential pressure (difference between the hydraulic pressure of the arterial blood circuit 2 near the inlet side of the dialyzer 1 and the hydraulic pressure of the venous blood circuit 3 near the outlet side) and TMP (blood). It may be the time when the hydraulic pressure on the blood flow path side through which the dialysate flows and the hydraulic pressure on the dialysate flow path side through which the dialysate flows) reaches a predetermined value. When the differential pressure of the dialyzer and the TMP exceed the threshold value, it can be determined that the hollow fiber membrane of the dialyzer 1 is clogged, so that it can be estimated that the treatment is interrupted and blood is returned.

Hereinafter, the control contents of the control means 21 according to the present embodiment will be described with reference to the flowchart of FIG. 2 and FIGS. 3 to 5.
First, the blood pump 4 is driven with the arterial puncture needle c and the venous side puncture needle d punctured in the patient to remove blood from the patient to the blood circuit (S1). After that, as shown in FIG. 3, the clamping means (Vc, Vd) on the blood circuit side is closed and the clamping means (Va, Vb) is opened, and the solenoid valve (V1, V3) on the dialysis apparatus main body B side is opened. ~ V8) is closed and the solenoid valves (V2, V9) are open, and the water pump 10 is driven while maintaining the drive of the blood pump 4 with the dual pump 7 stopped. Fibration therapy is started (S2).

In this ultrafiltration treatment of S2, blood is circulated extracorporeally in the blood circuit by driving the blood pump 4, and ultrafiltration is performed from the blood flowing through the hollow fiber membrane of the dialyzer 1 by driving the water removal pump 10. Water can be removed by action and discharged via the dialysate discharge line L2. Since the dialysate of the dialysate introduction line L1 is retained during the ultrafiltration treatment, the operation of the heater 17 is stopped.

After that, in the process of performing the ultrafiltration treatment, it is determined whether or not the preset timing has been reached (S3). Such a set timing is a timing that enables immediate response even if fluid replacement is performed as described above, for example, a time based on the start or end time of ultrafiltration treatment, a change in treatment conditions, or ultrafiltration. Based on the patient's condition or parameters related to the treatment condition detected during treatment, or based on the temperature or concentration detected by a detection means such as a concentration sensor 18 or a temperature sensor (19, 20) during ultrafiltration treatment. It is preferred to be determined.

When it is determined in S3 that the timing is set, the process proceeds to S4, and the double pump 7 is driven to send the dialysate while restricting the inflow of the dialysate into the dialyzer 1. In the ultrafiltration treatment in which this liquid transfer is performed, as shown in FIG. 4, the clamping means (Vc, Vd) on the blood circuit side is closed and the clamping means (Va, Vb) is opened, and dialysis is performed. The solenoid valves (V1, V4, V5, V7) on the device body B side are closed and the solenoid valves (V2, V3, V6, V8, V9) are opened. Then, by driving the water removal pump 10 while maintaining the driving of the blood pump 4 while driving the compound pump 7, the ultrafiltration treatment accompanied by the liquid feeding is performed.

In the ultrafiltration treatment of S4, blood is circulated extracorporeally in the blood circuit by driving the blood pump 4, and ultrafiltration is performed from the blood flowing through the hollow thread membrane of the dialyzer 1 by driving the water removal pump 10. It is possible to remove water by action and discharge the dialysate through the dialysate discharge line L2, and to flow the dialysate on the dialysate introduction line L1, bypass line L3 and dialysate discharge line L2 by driving the double pump 7. it can. While this ultrafiltration treatment is being performed, the retention of the dialysate in the dialysate introduction line L1 is eliminated, and the heater 17 is operated to heat the dialysate.

After that, when emergency fluid replacement is required, emergency fluid replacement will be performed in S5. In such an emergency fluid replacement, as shown in FIG. 5, the clamping means (Va, Vd) on the blood circuit side is closed and the clamping means (Vb, Vc) is opened, and the solenoid valve on the dialysis machine body B side. (V1, V2, V4, V7) is closed and the solenoid valves (V3, V5, V6, V8, V9) are opened. Then, while the dual pump 7 is being driven, the water removal pump 10 is stopped while maintaining the driving of the blood pump 4, so that the dialysate of the dialysate introduction line L1 is passed through the dialysate supply line La to the blood circuit. It can be used as a treatment for lowering blood pressure by supplying the dialysate to the patient and introducing the dialysate into the patient's body as a supplement.

Since the emergency replacement fluid of S5 is performed after the ultrafiltration treatment accompanied by the fluid delivery of S4, the dialysate having a set temperature or concentration (composition) heated by the heater 17 can be supplied to the blood circuit. Therefore, the preparatory operation can be eliminated, and the dialysate of the dialysate introduction line L1 can be immediately supplied to the blood circuit during the ultrafiltration treatment to perform replacement fluid. In this way, after the fluid replacement is performed, as shown in FIG. 3, the ultrafiltration treatment without fluid delivery (details as described above) is restarted (S6), and in the process, at a preset timing. Whether or not it has been reached is determined (S7).

The timing set at this time is a timing that enables immediate response even if blood is returned as described above, for example, a time based on the start or end time of ultrafiltration treatment or a time when the treatment condition is changed. Temperature or concentration detected based on the patient's condition or parameters related to the treatment condition detected during ultrafiltration treatment, or by a detection means such as concentration sensor 18 or temperature sensor (19, 20) during ultrafiltration treatment. It is preferable to determine based on. When it is determined in S7 that the timing is set, the process proceeds to S8, and as shown in FIG. 4, the dual pump 7 is driven while restricting the inflow of dialysate into the dialyzer 1, and ultrafiltration treatment accompanied by liquid feeding. Is performed (details are as described above).

After that, when the blood is returned after the treatment, the blood is returned in S9. In such blood return, as shown in FIG. 5, the clamping means (Va, Vd) on the blood circuit side is closed and the clamping means (Vb, Vc) is opened, and the solenoid valve on the dialysis apparatus main body B side. (V1, V2, V4, V7) is closed and the solenoid valves (V3, V5, V6, V8, V9) are open. Then, while the double pump 7 is being driven, the water removal pump 10 is stopped while maintaining the driving of the blood pump 4, so that the dialysate of the dialysate introduction line L1 is passed through the dialysate supply line La to the blood circuit. By substituting the dialysate with the blood in the blood circuit, the blood in the blood circuit can be returned to the patient.

Since the blood return in S9 is performed after the ultrafiltration treatment accompanied by the liquid feeding in S8, the dialysate having a set temperature or concentration (composition) heated by the heater 17 can be supplied to the blood circuit. Therefore, the preparatory operation can be eliminated, and the dialysate of the dialysate introduction line L1 can be immediately supplied to the blood circuit to return blood after the ultrafiltration treatment. This completes the blood purification treatment.

According to the above embodiment, when ultrafiltration treatment is performed in which the water removal pump 10 is driven to remove water while stopping the introduction of the dialysate into the dialyzer 1, dialysis is performed while restricting the inflow of the dialysate into the dialyzer 1. Since the liquid is sent, the dialysate of the dialysate introduction line L1 is immediately supplied to the blood circuit during the ultrafiltration treatment to supplement the fluid without going through the preparatory operation, or after the ultrafiltration treatment. The dialysate from the dialysate introduction line can be immediately supplied to the blood circuit to return blood. In the present embodiment, the ultrafiltration treatment accompanied by the liquid feeding is performed by driving the double pump 7, but the liquid may be fed by another liquid feeding means.

Further, during the ultrafiltration treatment, the flow path is closed by the solenoid valve V1 (closing means) and the dialysate sent by the dual pump 7 (liquid sending means) is flowed by the bypass line L3. It is possible to regulate the inflow of the dialysate into the dialyzer 1 while allowing the dialysate sent by the pump 7 to flow through the bypass line L3. In the present embodiment, during the ultrafiltration treatment accompanied by liquid feeding, the solenoid valve V3 is opened and the dialysate is flowed through the bypass line L3. As shown in FIG. 6, the solenoid valve V4 is used. The dialysate may be allowed to flow through the bypass line L4 in the open state.

Furthermore, since the dialysate is delivered at a preset timing during the ultrafiltration treatment, the amount of dialysate consumed is compared with that of the dialysate being delivered at all times of the ultrafiltration treatment. Can be reduced, and the cost can be reduced. In addition, if the preset timing is determined at the time based on the start time or end time of the ultrafiltration treatment or at the time when the treatment conditions are changed, the dialysate is set at an appropriate timing during the ultrafiltration treatment. Can be sent.

Furthermore, since the preset timing is determined based on the parameters related to the patient's condition or the treatment condition detected during the ultrafiltration treatment, the timing is appropriate according to the patient's condition or the treatment condition. The dialysate can be sent. Further, since the preset timing is determined based on the temperature or concentration detected by the detection means (concentration sensor 18, temperature sensor 19, 20) during the ultrafiltration treatment, the temperature or concentration of the dialysate can be used. The dialysate can be sent at an appropriate timing according to the situation.

Further, during the ultrafiltration treatment, the dialysate is heated by the heater 17 (heating means) while the dialysate is being sent, so that the replacement solution during the ultrafiltration treatment and the return after the ultrafiltration treatment are performed. The dialysate supplied to the blood circuit in the blood can be at an appropriate temperature. In the present embodiment, the dialysate is heated by the heater 17 arranged in the dialysate introduction line L1 during the ultrafiltration treatment accompanied by the liquid feeding, but other heating means (for example, dialysis). The dialysate may be heated by a heater or the like installed outside the apparatus main body B).

Next, the blood purification apparatus according to the second embodiment of the present invention will be described.
The blood purification device according to the present embodiment is applied to the hemodialysis device as in the first embodiment, and as shown in FIG. 1, the dialyzer 1 as a blood purification means has an arterial blood circuit 2 and an arterial blood purification device. A blood circuit to which the venous blood circuit 3 is connected, a dialyzer main body B having a double pump 7, a water removal pump 10, a dialysate introduction line L1 and a dialysate discharge line L2, and a dialysate supply line La are controlled. It is mainly composed of means 21 and the like.

In this embodiment, the configuration is the same as that in the first embodiment, but the content of control by the control means 21 is different. Hereinafter, the control contents of the control means 21 according to the present embodiment will be described with reference to the flowchart of FIG. 7 and FIGS. 3 to 5.
First, the blood pump 4 is driven with the arterial puncture needle c and the venous side puncture needle d punctured in the patient to remove blood from the patient to the blood circuit (S1). After that, as shown in FIG. 4, the clamping means (Vc, Vd) on the blood circuit side is closed and the clamping means (Va, Vb) is opened, and the solenoid valve (V1, V4) on the dialysis apparatus main body B side is opened. , V5, V7) in the closed state and the solenoid valves (V2, V3, V6, V8, V9) in the open state, and in the state where the compound pump 7 is driven, the water removal pump 10 is maintained while the blood pump 4 is driven. By driving the above, ultrafiltration treatment accompanied by pumping is performed (S2).

In the ultrafiltration treatment of S2, blood is circulated extracorporeally in the blood circuit by driving the blood pump 4, and ultrafiltration is performed from the blood flowing through the hollow thread membrane of the dialyzer 1 by driving the water removal pump 10. It is possible to remove water by action and discharge the dialysate through the dialysate discharge line L2, and to flow the dialysate on the dialysate introduction line L1, bypass line L3 and dialysate discharge line L2 by driving the double pump 7. it can. During this ultrafiltration treatment, the dialysate in the dialysate introduction line L1 is sent, and the heater 17 is operated to heat the dialysate.

After that, when emergency fluid replacement is required, emergency fluid replacement will be performed in S3. In such an emergency fluid replacement, as shown in FIG. 5, the clamping means (Va, Vd) on the blood circuit side is closed and the clamping means (Vb, Vc) is opened, and the solenoid valve on the dialysis machine body B side. (V1, V2, V4, V7) is closed and the solenoid valves (V3, V5, V6, V8, V9) are opened. Then, while the dual pump 7 is being driven, the water removal pump 10 is stopped while maintaining the driving of the blood pump 4, so that the dialysate of the dialysate introduction line L1 is passed through the dialysate supply line La to the blood circuit. It can be used as a treatment for lowering blood pressure by supplying the dialysate to the patient and introducing the dialysate into the patient's body as a supplement.

Since the emergency replacement fluid of S3 is performed after the ultrafiltration treatment accompanied by the fluid delivery of S2, the dialysate having a set temperature or concentration (composition) heated by the heater 17 can be supplied to the blood circuit. Therefore, the preparatory operation can be eliminated, and the dialysate of the dialysate introduction line L1 can be immediately supplied to the blood circuit during the ultrafiltration treatment to perform replacement fluid. Thus, after fluid replacement is performed, as shown in FIG. 4, ultrafiltration therapy with fluid delivery (details as described above) is resumed (S4).

After that, when the blood is returned after the treatment, the blood is returned in S5. In such blood return, as shown in FIG. 5, the clamping means (Va, Vd) on the blood circuit side is closed and the clamping means (Vb, Vc) is opened, and the solenoid valve on the dialysis apparatus main body B side. (V1, V2, V4, V7) is closed and the solenoid valves (V3, V5, V6, V8, V9) are open. Then, while the double pump 7 is being driven, the water removal pump 10 is stopped while maintaining the driving of the blood pump 4, so that the dialysate of the dialysate introduction line L1 is passed through the dialysate supply line La to the blood circuit. By substituting the dialysate with the blood in the blood circuit, the blood in the blood circuit can be returned to the patient.

Since the blood return in S5 is performed after the ultrafiltration treatment accompanied by the liquid feeding in S4, the dialysate having a set temperature or concentration (composition) heated by the heater 17 can be supplied to the blood circuit. Therefore, the preparatory operation can be eliminated, and the dialysate of the dialysate introduction line L1 can be immediately supplied to the blood circuit to return blood after the ultrafiltration treatment. This completes the blood purification treatment.

According to the above embodiment, when ultrafiltration treatment is performed in which the water removal pump 10 is driven to remove water while stopping the introduction of the dialysate into the dialyzer 1, dialysis is performed while restricting the inflow of the dialysate into the dialyzer 1. Since the liquid is sent, the dialysate of the dialysate introduction line L1 is immediately supplied to the blood circuit during the ultrafiltration treatment to supplement the fluid without going through the preparatory operation, or after the ultrafiltration treatment. The dialysate from the dialysate introduction line can be immediately supplied to the blood circuit to return blood.

Further, since the blood purification device according to the present embodiment performs only the ultrafiltration treatment accompanied by the liquid feeding in the ultrafiltration treatment, the liquid feeding is accompanied by the liquid feeding at the set timing as in the first embodiment. It is possible to more reliably eliminate the need for preparatory operation as compared with the case where ultrafiltration treatment is performed. In the present embodiment, the ultrafiltration treatment accompanied by the liquid feeding is performed by driving the double pump 7, but the liquid may be fed by another liquid feeding means.

Further, during the ultrafiltration treatment, the dialysate is heated by the heater 17 (heating means) while the dialysate is being sent, so that the replacement solution during the ultrafiltration treatment and the return after the ultrafiltration treatment are performed. The dialysate supplied to the blood circuit in the blood can be at an appropriate temperature. In the present embodiment, the dialysate is heated by the heater 17 arranged in the dialysate introduction line L1 during the ultrafiltration treatment accompanied by the liquid feeding, but other heating means (for example, dialysis). The dialysate may be heated by a heater or the like installed outside the apparatus main body B).

Although the present embodiment has been described above, the present invention is not limited to these. For example, a blood purification device capable of supplying a dialysate from the dialysate introduction line L1 to a blood circuit to supplement or return blood. If so, the replacement solution is performed by supplying the dialysate of the dialysate introduction line L1 and the blood is returned by introducing another replacement solution such as physiological saline, or the dialysate of the dialysate introduction line L1 is supplied. The blood may be returned by the blood, and the supplementary solution may be prepared by introducing another supplementary solution such as a physiological saline solution. Further, in the present embodiment, both emergency fluid replacement and blood return are controlled to be performed, but it may be controlled so that only one of emergency fluid replacement or blood return is performed. The control means 21 may be arranged outside the dialysis machine main body B.

When ultrafiltration treatment is performed in which the water removal pump is driven to remove water while stopping the introduction of dialysate to the blood purification means, the dialysate is sent while restricting the inflow of dialysate to the blood purification means. As long as it is a blood purification device that can be used, it can be applied to devices with other functions added.

1 ... Dializer (blood purification means)
2 ... Arterial blood circuit 3 ... Intravenous blood circuit 4 ... Blood pump 5 ... Arterial air trap chamber 6 ... Intravenous air trap chamber 7 ... Duplex pump 8, 9 ... Filter filter 10 ... Water removal pump 11 ... Collection port 12 ... Hydraulic pressure measurement sensor 13 ... Venous pressure sensor 14 ... Pressurized pump 15 ... Degassing chamber 16 ... Bubble detection sensor 17 ... Heater (heating means)
18 ... Concentration sensor (detection means)
19, 20 ... Temperature sensor (detection means)
21 ... Control means L1 ... Dialysate introduction line L2 ... Dialysate discharge line L7 ... Atmospheric release line La ... Dialysate supply line Lb Overflow line B ... Dialysate body a, b ... Connector

The invention according to claim 1 is connected between a blood circuit having an arterial blood circuit and a venous blood circuit capable of extracorporeally circulating a patient's blood, and the arterial blood circuit and the venous blood circuit, and the blood. A blood purification means for purifying blood flowing through a circuit, a dialysate introduction line capable of introducing dialysate into the blood purification means, a dialysate discharge line capable of discharging drainage from the blood purification means, and the blood purification It is provided with a bypass line capable of bypassing the means and allowing the dialysate of the dialysate introduction line to flow to the dialysate discharge line, and a water removal pump capable of removing water from blood flowing through the blood circuit via the blood purification means. A blood purification device capable of supplementing or returning blood by supplying the dialysate from the dialysate introduction line to the blood circuit, and removing the water while stopping the introduction of the dialysate into the blood purification means. When the ultrafiltration treatment in which the water is removed by driving the pump is performed, the dialysate is sent to the bypass line while restricting the inflow of the dialysate to the blood purification means, and further, the ultrafiltration treatment is performed. In the process of, it is determined whether or not the preset timing has been reached, and if it is not determined that the preset timing has been reached, the limitation is limited without sending dialysate to the bypass line. When the filtration treatment is performed and it is determined that the preset timing has been reached, the extraneous filtration treatment is performed with the dialysate being sent to the bypass line, and further, the extraneous filtration treatment is being performed. It is characterized in that the supplementary solution is performed in the blood, or the blood is returned after the ultrafiltration treatment .

According to a second aspect of the invention, the blood purification apparatus according to claim 1, wherein the dialysate and feeding means capable of feeding said blood purification means dialysate introduction line, the bypass before Symbol dialysate inlet line When it is determined that the preset timing has been reached at the time of the ultrafiltration treatment, which is configured to include a closing means capable of closing the flow path between the connection portion of the line and the blood purification means. It is characterized in that the flow path is closed by the closing means and the dialysate sent by the liquid feeding means is flowed by the bypass line.

The invention according to claim 3 comprises the liquid feeding means which can feed the dialysate of the dialysate introduction line to the blood purifying means in the blood purifying apparatus according to claim 1 or 2, and the extraneous filtration. If it is not determined that the preset timing has been reached during the treatment, the ultrafiltration treatment is performed without sending the dialysate by stopping the driving of the liquid feeding means while driving the water removal pump. Then, when it is determined that the preset timing has been reached, the dialysate is fed by driving the water removal pump and the liquid feeding means to perform the ultrafiltration treatment.

The invention according to claim 4 is the blood purification apparatus according to any one of claims 1 to 3 , wherein the preset timing is a time or treatment condition based on the start time or end time of the ultrafiltration treatment. It is characterized in that it is decided at the time of change of.

The invention according to claim 5 is the blood purification apparatus according to any one of claims 1 to 3 , wherein the preset timing is the state of the patient or the state of treatment detected during the ultrafiltration treatment. It is characterized in that it is determined based on the parameters related to.

The invention according to claim 6 is provided with a heating means capable of heating the dialysate in the blood purification apparatus according to any one of claims 1 to 5 , and at the time of the ultrafiltration treatment, the above-mentioned advance. When it is determined that the set timing has been reached, the dialysate is heated by the heating means while the dialysate is being sent.

According to the invention of claim 1, when the extrafiltration treatment in which the water removal pump is driven to remove water while stopping the introduction of the dialysate into the blood purification means is performed, the inflow of the dialysate into the blood purification means is regulated. Since the dialysate is sent while the dialysate is sent, the dialysate from the dialysate introduction line is immediately supplied to the blood circuit during the ultrafiltration treatment without going through the preparatory operation to supplement the fluid, or the ultrafiltration treatment. After that, the dialysate from the dialysate introduction line can be immediately supplied to the blood circuit to return blood.
In addition, since the dialysate is sent at a preset timing during the ultrafiltration treatment, the amount of dialysate consumed is compared with that of the dialysate being sent at all times of the ultrafiltration treatment. Can be reduced, and the cost can be reduced.

According to the invention of claim 6 , during the ultrafiltration treatment, the dialysate is heated by the heating means while the dialysate is being sent, so that the replacement solution or the ultrafiltration treatment during the ultrafiltration treatment is performed. The dialysate supplied to the blood circuit in the subsequent blood return can be brought to an appropriate temperature.

Claims (7)

A blood circuit having an arterial blood circuit and a venous blood circuit that can circulate the patient's blood extracorporeally,
A blood purification means connected between the arterial blood circuit and the venous blood circuit to purify the blood flowing through the blood circuit,
A dialysate introduction line capable of introducing dialysate into the blood purification means,
A dialysate discharge line capable of draining the drainage from the blood purification means,
A water removal pump capable of removing water from blood flowing through the blood circuit via the blood purification means,
A blood purification device that is capable of replenishing or returning blood by supplying the dialysate from the dialysate introduction line to the blood circuit.
When ultrafiltration treatment is performed in which the water removal pump is driven to remove water while stopping the introduction of the dialysate into the blood purification means, the dialysate is sent while restricting the inflow of the dialysate into the blood purification means. A blood purification device characterized by allowing liquid to be performed. A liquid feeding means capable of feeding the dialysate of the dialysate introduction line to the blood purification means, and a bypass line capable of bypassing the blood purification means and allowing the dialysate of the dialysate introduction line to flow to the dialysate discharge line. And a closing means capable of closing the flow path between the connection portion of the bypass line in the dialysate introduction line and the blood purification means. The blood purification apparatus according to claim 1, wherein the flow path is closed and the dialysate fed by the liquid feeding means is allowed to flow in the bypass line. The blood purification apparatus according to claim 1 or 2, wherein the dialysate is sent at a preset timing during the ultrafiltration treatment. The blood purification apparatus according to claim 3, wherein the preset timing is determined at a time based on the start time or end time of the ultrafiltration treatment or at a time when the treatment conditions are changed. The blood purification apparatus according to claim 3, wherein the preset timing is determined based on a parameter relating to a patient's condition or a treatment condition detected during the ultrafiltration treatment. A detection means capable of detecting the temperature or concentration of the dialysate in the dialysate introduction line is provided, and the preset timing is based on the temperature or concentration detected by the detection means during the ultrafiltration treatment. 3. The blood purification apparatus according to claim 3, wherein the blood purification device is determined. A claim characterized in that the dialysate is provided with a heating means capable of heating the dialysate, and the dialysate is heated by the heating means while the dialysate is being sent during the ultrafiltration treatment. Item 4. The blood purification apparatus according to any one of Items 1 to 6.

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