JP6429527B2 - Blood purification equipment - Google Patents

Description

  The present invention relates to a blood purification apparatus for purifying a patient's blood while circulating it extracorporeally, such as dialysis treatment using a dialyzer.

  Generally, at the time of dialysis treatment, a blood circuit for circulating the collected patient's blood extracorporeally and returning it to the body is used. Such a blood circuit is, for example, a dialyzer (blood purification means) having a hollow fiber membrane. It is mainly composed of an arterial blood circuit and a venous blood circuit that can be connected to each other. An arterial puncture needle and a venous puncture needle are attached to the tips of the arterial blood circuit and the venous blood circuit, respectively, and are punctured by the patient to perform extracorporeal circulation of blood in dialysis treatment.

  Among these, the arterial blood circuit is provided with an iron-type blood pump, and the blood pump is driven in a state in which the patient is punctured with the arterial puncture needle and the venous puncture needle. The blood collected from can be sent to the dialyzer while circulating outside the body. Furthermore, an arterial air trap chamber and a venous air trap chamber are connected to the arterial blood circuit and the venous blood circuit, respectively, and after the extracorporeally circulated blood is defoamed (removal of bubbles), the patient's body. It is configured to be returned to.

  By the way, in the conventional blood purification apparatus, as disclosed in Patent Document 1, before priming, a closed circuit is formed in the blood circuit including the connection position of the pressure detection sensor, and applied to the inside of the closed circuit. A device has been proposed that performs a self-diagnosis step of diagnosing the quality of the connection state of the blood circuit based on the detection value of the pressure detection sensor that changes by pressure. That is, the detected value of the pressure detection sensor that changes by pressurizing the inside of the closed circuit is monitored. For example, if a predetermined pressure is reached within a predetermined time, it can be estimated that there is no leakage of pressurized air at least in the closed circuit. Therefore, it is determined that the connection of the blood circuit is appropriate, and if the predetermined pressure is not reached within the predetermined time, it can be estimated that the pressurized air is leaking at least in the closed circuit. To be judged.

International Publication 2012/017959

The conventional blood purification apparatus has the following problems.
Blood purification means used at the time of blood purification treatment are usually a wet type in which a blood flow path through which blood flows and a dialysate flow path in which dialysate flows are pre-filled with a filling type, and a dry type in which the filling liquid is not filled. In addition, there are dialyzers that are generally distributed, and doctors and the like can arbitrarily select one of the dialysers in consideration of various circumstances.

  However, due to the difference in properties between a compressible gas such as air and an incompressible liquid such as a filling liquid, the dry dialyzer is better than the wet dialyzer against pressurization in the self-diagnosis process. Since there is a tendency that it is difficult to pressurize and it is difficult to maintain the pressure, the change tendency of the detection value of the pressure detection sensor with respect to pressurization differs depending on the type of dialyzer used.

  Specifically, the pressure is applied to the blood circuit (closed circuit) to which the wet type dialyzer is connected (see FIG. 18) and the blood circuit (closed circuit) to which the dry type dialyzer is connected. When observing the pressure change when pressure is applied (see FIG. 19), the pressure change from the start of pressurization (i) to the end of pressurization (ii) is more gradual in the dry dialyzer (ie, to a predetermined pressure). It can be seen that this tendency takes time. In the figure, (iii) shows the end of the confirmation of pressure retention after pressurization. Therefore, in the self-diagnosis process, whether the dry type or the wet type is used, if the quality of the connection state is diagnosed under the same conditions, the judgment criterion (alarm point) becomes too sweet or severe. There is a problem that the accuracy is deteriorated.

  The present invention has been made in view of such circumstances, and the self-diagnosis process is accurately performed regardless of whether wet type blood purification means or dry type blood purification means is selected and used. An object of the present invention is to provide a blood purification device that can be used.

The invention according to claim 1 is composed of an arterial blood circuit and a venous blood circuit, a blood circuit capable of extracorporeally circulating a patient's blood from the tip of the arterial blood circuit to the tip of the venous blood circuit, and the blood Dialysis that is inserted between the arterial blood circuit and the venous blood circuit of the circuit to purify the blood flowing through the blood circuit and through which the blood of the patient flows and the dialysate flows through the blood purification membrane A blood purification means in which a liquid flow path is formed, a blood pump disposed in the arterial blood circuit, a pressure detection means connected to a predetermined flow path and capable of detecting the pressure in the flow path, and the blood A closed circuit is formed including the connection position of the pressure detection means in the circuit, and the quality of the connection state of the blood circuit is diagnosed based on the detection value of the pressure detection means that changes by pressurizing the closed circuit. Self Control means capable of performing a diagnostic process, and the blood purification means is either a wet type in which the blood flow path and the dialysate flow path are pre-filled with a filling liquid or a dry type in which the filling liquid is not filled. Is a blood purification apparatus in which blood purification treatment is performed by being connected to the blood circuit, wherein the control means determines whether the blood purification means connected to the blood circuit is a wet type or a dry type. together to perform determination steps that may determine, depending on the type of the blood purification means which is determined in the determination step, when the self-diagnosis step, and wherein the diagnosing the quality of the connection state before Symbol blood circuit .

According to a second aspect of the invention, the blood purification apparatus according to claim 1, wherein, in the said blood circuit, with detectable detection means a gas or liquid in the flow path are connected, the determination step, the The blood pump is driven to cause the gas or liquid in the blood flow path of the blood purification means to flow to the connection position of the detection means, and when the detection means detects the liquid, it is determined to be a wet type, and the detection When the gas is detected by the means, it is discriminated that it is a dry type.

According to a third aspect of the present invention, in the blood purification apparatus according to the second aspect , the detection means is connected between the blood purification means and the arterial air trap chamber, and during the blood purification treatment, the arterial blood circuit It is characterized by comprising a bubble detector capable of detecting gas in blood flowing from the blood to the blood purification means and capable of detecting gas or liquid in the discrimination step.

According to a fourth aspect of the present invention, in the blood purification apparatus according to the second aspect , the detection means is connected to a distal end portion of the arterial blood circuit or a distal end portion of the venous side blood circuit, and the arteries are treated during blood purification treatment. It is characterized by comprising a bubble detector capable of detecting a gas in blood flowing through the side blood circuit or the venous side blood circuit and capable of detecting gas or liquid in the discrimination step.

According to a fifth aspect of the present invention, in the blood purification apparatus according to the second aspect , the detection means is connected to the arterial blood circuit or the venous blood circuit, and during the blood purification treatment, the arterial blood circuit or the venous side It comprises a blood concentration detector capable of detecting the concentration of blood flowing in the blood circuit and capable of detecting gas or liquid in the discrimination step.

The invention according to claim 6 is the blood purification apparatus according to claim 2 , wherein the artery side air trap chamber connected to the artery side blood circuit and the artery side air trap chamber are connected to the artery side air trap chamber. And a liquid level adjusting means capable of adjusting the liquid level by arbitrarily introducing or discharging air, and the determination step is performed by driving the liquid level adjusting means instead of the blood pump. The gas or liquid in the blood flow path of the blood purification means flows to the connection position of the detection means.

A seventh aspect of the present invention is the blood purification apparatus according to the sixth aspect, wherein the liquid level adjusting means includes a liquid level adjusting pump capable of normal rotation driving and reverse rotation driving, and the control means is configured to perform the priming operation. The liquid level adjusting pump can be driven at an arbitrary timing so that air can be introduced into or discharged from the upper part of the arterial air trap chamber.
According to an eighth aspect of the present invention, in the blood purification apparatus according to any one of the first to seventh aspects, the control means determines the blood according to the type of the blood purification means determined in the determination step. It is characterized by changing a threshold value for determining whether the circuit connection state is good or bad.

  According to the invention of claim 1, since the control means diagnoses the quality of the connection state of the blood circuit according to the type of the blood purification means connected to the blood circuit during the self-diagnosis process, the wet blood purification means Alternatively, the self-diagnosis process can be performed with high accuracy regardless of which dry blood purification means is selected and used.

In addition , the control means performs a determination step that can determine whether the blood purification means connected to the blood circuit is a wet type or a dry type, and the type of the blood purification means determined in the determination step. Accordingly, since the quality of the connection state of the blood circuit is diagnosed during the self-diagnosis process, it is possible to automatically determine the type of the blood purification means and perform the self-diagnosis process with high accuracy.

According to the invention of claim 2 , the blood circuit is connected to the detection means capable of detecting the gas or liquid in the flow path, and the determination step drives the liquid level adjustment means or the blood pump, When the gas or liquid in the blood flow path of the blood purification means flows to the connection position of the detection means, it is determined that the detection means is wet when the liquid is detected, and the dry type when the detection means detects gas Therefore, the type of blood purification means can be more easily and reliably determined.

According to the invention of claim 3 , the detection means is connected between the blood purification means and the artery side air trap chamber, and detects a gas in blood flowing from the artery side blood circuit to the blood purification means during the blood purification treatment. In addition, since it is composed of a bubble detector that can detect a gas or a liquid in the determination step, it is possible to use the bubble detector used during blood purification treatment to make the determination in the determination step.

According to the invention of claim 4 , the detection means is connected to the tip of the arterial blood circuit or the tip of the venous blood circuit, and in blood flowing through the arterial blood circuit or venous blood circuit during blood purification treatment It is possible to detect the gas in the determination step, and to detect the gas or liquid in the determination step, so that the determination by the determination step can be performed by diverting the bubble detector used during the blood purification treatment. it can.

According to the invention of claim 5 , the detection means is connected to the arterial blood circuit or the venous blood circuit, and can detect the concentration of blood flowing through the arterial blood circuit or the venous blood circuit during the blood purification treatment. Since the blood concentration detector is capable of detecting gas or liquid in the determination step, the blood concentration detector used during the blood purification treatment can be diverted to perform the determination in the determination step.

According to the sixth aspect of the present invention, the artery side air trap chamber connected to the artery side blood circuit and the artery side air trap chamber are connected, and air is arbitrarily introduced into or discharged from the artery side air trap chamber. And a liquid level adjusting means capable of adjusting the liquid level, and the determining step drives the liquid level adjusting means instead of the blood pump, thereby allowing the gas or liquid in the blood flow path of the blood purification means to be Since the fluid flows to the connection position of the detection means, the type of the blood purification means can be determined using the liquid level adjustment means.

According to the seventh aspect of the present invention, the liquid level adjusting means includes the liquid level adjusting pump capable of forward driving and reverse driving, and the control means drives the liquid level adjusting pump at an arbitrary timing during priming. Thus, air can be introduced into or discharged from the upper part of the artery-side air trap chamber, so that the type of the blood purification means can be more accurately determined by diverting the liquid level adjustment pump.

The schematic diagram which shows the blood purification apparatus which concerns on the 1st Embodiment of this invention. Flow chart showing control contents before treatment by the blood purification apparatus The flowchart which shows the control content of the discrimination | determination process by the blood purification apparatus Flow chart showing control contents of self-diagnosis process by the blood purification apparatus The flowchart which shows the control content of the priming process by the blood purification apparatus Schematic diagram showing a state where the self-diagnosis process by the blood purification apparatus is being performed The schematic diagram which shows the state in which the discrimination | determination process by the blood purification apparatus is performed The schematic diagram which shows the state in which the other discrimination | determination process by the blood purification apparatus is performed The schematic diagram which shows the state in which the priming process by the blood purification apparatus is performed A plan view and a front view showing a blood concentration detector in the blood purification apparatus XI-XI line sectional view in FIG. Plan view showing a bubble detector and a blood discriminator in the blood purification apparatus XIII-XIII line sectional view in FIG. Sectional view showing the bubble detector Sectional view showing the blood discriminator The schematic diagram which shows the state in which the discrimination | determination process by the blood purification apparatus which concerns on the 2nd Embodiment of this invention is performed. The schematic diagram which shows the blood purification apparatus which concerns on other embodiment of this invention. Graph showing pressure change when pressurizing blood circuit (closed circuit) to which wet type dialyzer is connected A graph showing the pressure change when a blood circuit (closed circuit) connected to a dry dialyzer is pressurized

Hereinafter, embodiments of the present invention will be specifically described with reference to the drawings.
The blood purification apparatus according to the first embodiment includes a dialysis apparatus for performing dialysis treatment. As shown in FIG. 1, a blood circuit including an arterial blood circuit 1 and a venous blood circuit 2, and an arterial blood. A dialyzer 3 interposed between the circuit 1 and the venous blood circuit 2 to purify blood flowing through the blood circuit, a squeezed blood pump 4 disposed in the arterial blood circuit 1, and an arterial blood circuit 1. Mainly from an arterial air trap chamber 5 connected to the venous side, a venous air trap chamber 6 connected to the venous blood circuit 2, a priming liquid supply line L3, a liquid level adjusting means A, and a control means C. It is configured.

  A connector a is connected to the tip of the arterial blood circuit 1, and an arterial puncture needle (not shown) can be connected via the connector a. An arterial air trap chamber 5 is disposed. On the other hand, a connector b is connected to the distal end of the venous blood circuit 2, and a venous puncture needle (not shown) can be connected via the connector b, and a venous air trap chamber is provided in the middle. 6 is connected.

  An overflow line La extends from the upper part of the vein side air trap chamber 6. The overflow line La is composed of a flow path whose tip is open to the atmosphere, and a clamping means Va (for example, an electromagnetic valve) is connected to the middle of the overflow line La. Thus, by opening the clamp means Va at an arbitrary timing, the liquid in the venous air trap chamber 6 can overflow.

  Then, the blood pump 4 is driven (forward rotation drive) in a state where the patient is punctured with the arterial puncture needle connected to the distal end of the arterial blood circuit 1 and the venous puncture needle connected to the distal end of the venous blood circuit 2. The blood of the patient reaches the dialyzer 3 through the arterial blood circuit 1 while being defoamed (removal of bubbles) in the arterial air trap chamber 5, and blood purification is performed by the dialyzer 3. The venous air trap chamber 6 removes bubbles (removes bubbles) and returns to the patient's body through the venous blood circuit 2. Thus, the blood of the patient can be purified by the dialyzer 3 while circulating externally from the tip of the arterial blood circuit 1 to the tip of the venous blood circuit 2 of the blood circuit.

  In addition, a blood concentration detector 12 capable of detecting the concentration of blood flowing through the artery side blood circuit 1 during the liquid purification treatment is connected to the artery side blood circuit 1 according to the present embodiment. The blood concentration detector 12 is called a hematocrit sensor, and is configured to measure the blood concentration based on the received light voltage obtained by receiving the light reflected from the blood flowing through the artery-side blood circuit 1. ing. Further, the blood concentration detector 12 may be connected to the venous blood circuit 2.

  More specifically, as shown in FIGS. 10 and 11, the blood concentration detector 12 includes a housing part including a lid part H1 and a main body part H2, a groove H2a formed in the main body part H2, and a main body part H2. And a pair of light emitting elements 12a and 12b and a light receiving element 12c. The groove H2a can be fitted with a part of a flexible tube constituting the arterial blood circuit 1, and is communicated with an accommodation space for accommodating the light emitting elements 12a, 12b and the light receiving element 12c through a slit. ing.

  The light emitting elements 12a and 12b are made of, for example, LEDs that can irradiate near infrared rays (near infrared LEDs), and the light receiving elements 12c are made of photodiodes. When the flexible tube is fitted in the groove H2a and the main body H2 is covered with the lid H1, and light is emitted from the light emitting elements 12a and 12b, the light enters the groove H2a through the slit. It is configured so as to reach the fitted flexible tube and be reflected by the blood flowing in the tube and received by the light receiving element 12c (so-called reflection type sensor configuration).

  Then, a hematocrit value indicating the blood concentration is obtained based on the received light voltage generated by the light receiving element 12c. That is, each component of blood such as red blood cells and plasma has its own light absorption characteristics, and this property is used to quantify the red blood cells necessary for measuring the hematocrit value electro-optically. Thus, the hematocrit value can be obtained. In the present embodiment, the blood concentration detector 12 is constituted by the so-called reflective sensor as described above, but the light emitting element emits light and the light transmitted to the blood is applied to the light receiving element. The hematocrit value (blood concentration) may be measured based on the received light voltage obtained by receiving the light.

  The blood concentration detector 12 is capable of detecting gas or liquid in a determination step described later in addition to the blood concentration. That is, when the flexible tube fitted in the groove H2a is not filled with liquid, the light receiving voltage of the light receiving element 12c is high, and when the flexible tube is filled with liquid, the light receiving element 12c Since the light reception voltage becomes lower, the light reception voltage tends to decrease in the order of air, filling liquid, and blood. Based on this tendency, gas or liquid (filling liquid or air) can be detected in the discrimination process.

  Furthermore, the distal end portion (near the connector a) of the arterial blood circuit 1 according to the present embodiment or the distal end portion (near the connector b) of the venous blood circuit 2 is placed on the arterial blood circuit 1 or venous side during blood purification treatment. Bubble detectors (D1, D2) capable of detecting gas (bubbles) in the blood flowing through the blood circuit 2 are connected. The bubble detectors (D1, D2) are formed in a unit including a blood discriminator 13 and clamp means (V1, V2) (for example, an electromagnetic valve) as shown in FIGS. In addition, the code | symbol R in the figure has shown the push rod for obstruct | occluding or opening a flexible tube by the electricity supply to a clamp means (V1, V2).

  This unit includes a housing portion including a lid portion H1 and a main body portion H2, a groove H2a formed in the main body portion H2, a bubble detector (D1, D2) disposed in the main body portion H2, and a blood discriminator 13. And clamping means (V1, V2). The groove H2a can be fitted with a part of a flexible tube constituting the arterial blood circuit 1 or the venous blood circuit 2, and an ultrasonic wave constituting the bubble detector (D1, D2) through the slit. An accommodation space for accommodating the receiving element α1 and the ultrasonic vibration element α2 and an accommodation space for accommodating the light emitting element β1 and the light receiving element β2 constituting the blood discriminator 13 are respectively communicated.

  The bubble detectors (D2, D3) are composed of sensors capable of detecting bubbles (air) flowing through the flexible tube fitted in the groove H2a. As shown in FIG. 14, for example, ultrasonic vibration composed of a piezoelectric element is used. An element α2 and an ultrasonic receiving element α1 made of a piezoelectric element are provided. Then, ultrasonic waves can be irradiated from the ultrasonic vibration element α2 toward the flexible tube constituting the arterial blood circuit 1 or the venous blood circuit 2 fitted in the fitting groove H2a, and the vibration is superfluous. It can be received by the sound wave receiving element α1. The ultrasonic receiving element α1 is configured such that the voltage changes in accordance with the received vibration, and is configured to detect that the bubble has flowed when the detected voltage exceeds a predetermined threshold. ing.

  That is, since the attenuation rate of ultrasonic waves is higher than that of blood or replacement liquid, the voltage (detected by the ultrasonic receiving element α1) exceeds a predetermined threshold value, so that the bubbles (gas) flowed. It is detected. Such bubble detectors (D1, D2) are capable of detecting gas or liquid (air or filling liquid) in a determination step described later by changing or adding a threshold value.

  The blood discriminator 13 is composed of a discrimination sensor capable of discriminating the presence or absence of blood flowing through the flexible tube fitted in the groove H2a. As shown in FIG. 15, for example, a light emitting element β1 made of LED and a light receiving element β2 It is equipped with. The light emitting element β1 and the light receiving element β2 are disposed on the left and right sides of the fitting groove H2a, respectively, and constitute the arterial blood circuit 1 or the venous blood circuit 2 fitted in the fitting groove H2a. Light can be irradiated from the light emitting element β1 toward the flexible tube, and the light can be received by the light receiving element β2.

  The light receiving element β2 is configured such that the voltage changes according to the amount of light received, and configured to be able to determine the presence or absence of blood flowing through the arterial blood circuit 1 and the venous blood circuit 2 based on the detected voltage. ing. That is, the transmittance of light emitted from the light emitting element β1 is different between blood and the replacement fluid (dialysis fluid in the present embodiment) (the replacement fluid such as dialysate has higher light transmittance than blood). Therefore, when the voltage detected by the light receiving element β2 exceeds a predetermined threshold, it is detected that the flowing liquid is replaced with blood from the replacement liquid. The blood discriminator 13 can detect a gas or a liquid (air or filling liquid) in a discrimination process described later by changing or adding a threshold value.

  Furthermore, the arterial blood circuit 1 according to the present embodiment is connected between the dialyzer 3 and the arterial air trap chamber 5, and in blood flowing from the arterial blood circuit 1 to the dialyzer 3 during blood purification treatment. A bubble detector D3 capable of detecting gas is connected. Like the bubble detectors (D1, D2) described above, the bubble detector D3 can irradiate ultrasonic waves from the ultrasonic vibration element toward the flexible tube constituting the arterial blood circuit 1, and the vibration thereof. Is received by the ultrasonic wave receiving element, and bubbles can be detected based on the received vibration.

  The bubble detector D3 is made of an accessory called a clip type, and can be placed at an arbitrary position (between the dialyzer 3 and the artery side air trap chamber 5 in the artery side blood circuit 1 in this embodiment). It can be attached to the flexible tube, and by changing or adding a threshold value, it is possible to detect gas or liquid (air or filling liquid) in a determination step described later. However, the bubble detectors (D1, D2, D3), the blood concentration detector 12, and the blood discriminator 13 can constitute the “detecting means” of the present invention.

  Liquid level adjusting means A is connected to the arterial air trap chamber 5 and the venous air trap chamber 6, respectively. The liquid level adjusting means A is built in or externally attached to the dialyzer main body B, and the arterial air circulation line L8 and the venous air circulation line L9, and the arterial air circulation line with the tip being open to the atmosphere. It mainly comprises an open line L10 connected to L8 and the venous air circulation line L9, and a liquid level adjustment pump 11.

  One end of the arterial air circulation line L8 is connected to the upper part (air layer side) of the arterial air trap chamber 5, and a clamp means V9 (for example, an electromagnetic valve) and an arterial pressure detection sensor P1 are connected. It consists of a flow path such as a flexible tube. The arterial pressure detection sensor P1 can detect the pressure in the upper part (air layer side) of the arterial air trap chamber 5, thereby detecting the pressure of blood flowing into the dialyzer 3 (inlet pressure of the dialyzer 3). It is possible.

  One end of the venous air flow line L9 is connected to the upper part (air layer side) of the venous air trap chamber 6, and a clamp means V10 (for example, an electromagnetic valve) and a venous pressure detecting sensor P2 are connected. It consists of a flow path such as a flexible tube. The vein-side pressure detection sensor 13 (a so-called “venous pressure sensor”) can detect the pressure in the upper part (air layer side) of the vein-side air trap chamber 6, and thereby The pressure (venous pressure) of the blood flowing through the blood circuit 2 can be detected.

  The open line L10 is composed of a flow path such as a flexible tube whose proximal end is connected to the arterial air circulation line L8 and the venous air circulation line L9 and whose distal end is open to the atmosphere. The liquid level adjusting pump 11 comprising a squeezing pump is disposed. The liquid level adjusting pump 11 has a squeezing portion that can be driven forward and backward, and the squeezing portion squeezes a flexible tube that forms the open line L10 in the longitudinal direction thereof, thereby causing arterial air. Air is introduced into or discharged from the upper part of the trap chamber 5 or the upper part of the venous air trap chamber 6.

  Note that the liquid level adjustment pump 11 indicates normal rotation drive when rotated clockwise in the figure, and reverse rotation drive when rotated counterclockwise (similarly, the blood pump 4 is rotated forward and rotated counterclockwise when rotated clockwise in the figure. Indicates reverse drive). The open line L10 is connected to the pressure detection sensor P3 and to the branch line L11. A clamp means V12 (for example, an electromagnetic valve) and a pressure detection sensor P4 are connected to the branch line L11. However, the pressure detection sensors P1 to P4 according to the present embodiment can constitute the pressure detection means of the present invention.

  Thus, when the liquid level adjustment pump 11 is driven to rotate forward, air is sucked from the tip of the open line L10. Therefore, when the clamp means V9 is in the open state, the arterial air trap via the arterial air circulation line L8. When air is introduced into the chamber 5 to lower the liquid level and the liquid level adjustment pump 11 is driven in reverse, air is discharged from the tip of the open line L10. Therefore, when the clamp means V9 is in the open state, the artery side Air is discharged from the artery side air trap chamber 5 through the air circulation line L8 to raise the liquid level.

  Similarly, when the liquid level adjustment pump 11 is driven to rotate forward, air is sucked from the tip of the open line L10. Therefore, when the clamp means V10 is in the open state, the venous air trap passes through the venous air circulation line L9. When air is introduced into the chamber 6 to lower the liquid level and the liquid level adjusting pump 11 is driven in reverse, the air is discharged from the tip of the open line L10. Therefore, when the clamping means V10 is in the open state, the vein side Air is discharged from the venous air trap chamber 6 through the air circulation line L9 to raise the liquid level.

  The dialyzer 3 includes a blood inlet 3a (blood inlet port), a blood outlet 3b (blood outlet port), a dialysate inlet 3c (dialysate channel inlet: dialysate inlet port) and a dialysate in its casing. A lead-out port 3d (dialysate flow path outlet: dialysate lead-out port) is formed, of which the arterial blood circuit 1 is connected to the blood introduction port 3a and the venous blood circuit 2 is connected to the blood lead-out port 3b. Has been. The dialysate inlet 3c and dialysate outlet 3d are connected to a dialysate inlet line L1 and a dialysate outlet line L2 extending from the dialyzer body B, respectively.

  A plurality of hollow fiber membranes (not shown) are accommodated in the dialyzer 3, and the hollow fibers constitute a blood purification membrane for purifying blood. In the dialyzer 3, a blood flow path (flow path between the blood inlet 3 a and the blood outlet 3 b) through which the patient's blood flows via a blood purification membrane and a dialysate flow path (dialysate) through which the dialysate flows. A flow path between the inlet 3c and the dialysate outlet 3d) is formed. The hollow fiber membrane constituting the blood purification membrane is formed with a number of minute holes (pores) penetrating the outer peripheral surface and the inner peripheral surface to form a hollow fiber membrane. Impurities and the like in the blood can pass through the dialysate.

  The dialyzer 3 according to the present embodiment includes a wet type in which a blood channel and a dialysate channel are preliminarily filled with a filling liquid such as distilled water, and a dry type that is not filled with the filling liquid (that is, filled with air). There are two types. Dialysers other than wet and dry types are also classified as either wet or dry types. For example, in recent years, a dialyzer called a moist type in which a hollow fiber membrane is moistened has appeared. In the present invention, a dialyzer having such a wetted hollow fiber membrane is classified as a dry type.

  The dialyzer body B has a dialysate introduction line L1 and a dialysate discharge line L2, and also has a dual pump 7, bypass lines L4 to L7, and clamp means V3 to V8 (for example, solenoid valves). Among these, the duplex pump 7 is disposed across the dialysate introduction line L1 and the dialysate discharge line L2, and introduces the dialysate prepared to a predetermined concentration into the dialyzer 3 via the dialysate introduction line L1, The dialysate after dialysis is discharged from the dialyzer 3 through the dialysate discharge line L2.

  In the middle of the dialysate introduction line L1 (between the connecting portion of the dialysate introduction line L1 with the priming fluid supply line L3 and the dialyzer 3), the clamp means V4 is connected and in the middle of the dialysate discharge line L2 ( A clamping means V5 is connected between the dialysate discharge line L2 and the dialyzer 3 between the connecting portion of the dialysate discharge line L2 and the bypass line L4. Further, filtration filters 8 and 9 are connected between the dual pump 7 and the clamp means V4 in the dialysate introduction line L1. The filtration filters 8 and 9 are used for filtering and purifying the dialysate flowing through the dialysate introduction line L1, and the primary side of the filtration filters 8 and 9 is bypassed to the dialysate discharge line L2 and dialyzed. Bypass lines L4 and L5 for guiding the liquid are respectively connected. Clamping means V7 and V6 are connected to the bypass lines L4 and L5, respectively.

  Furthermore, the dialysate discharge line L2 is connected to bypass lines L6 and L7 that bypass the duplex pump 7, and the bypass line L6 removes water from the blood of the patient flowing in the blood flow path of the dialyzer 3. In addition, a dewatering pump 10 is disposed, and a clamp means V8 capable of opening and closing the flow path is disposed in the bypass line L7. In addition, a pump for adjusting the fluid pressure on the drain side in the dual pump 7 (between the connection with the bypass line L5 and the dual pump 7) upstream of the dual pump 7 in the dialysate discharge line L2 ( (Not shown) is provided.

  The priming liquid supply line L3 is composed of a flow path such as a flexible tube capable of supplying dialysate as a priming liquid to the arterial blood circuit 1 and the venous blood circuit 2 during priming before blood purification treatment. One end is connected to a predetermined part (between the filtration filter 9 and the clamp means V4) in the dialysate introduction line L1, and the other end is connected to a connection part T (the clamp means V1 and the blood pump 4 between the arterial blood circuit 1). Between) and connected. In the middle of the priming fluid supply line L3, clamping means V11 (for example, an electromagnetic valve) that can open and close the flow path is disposed, and when the clamping means V11 is open, the dialysis fluid introduction line L1 The dialysate can be supplied to the blood circuit (arterial blood circuit 1 and venous blood circuit 2).

  However, the clamping means V1 to V11 in the blood purification apparatus according to the present embodiment can close and open the flow paths at the respective locations by the opening and closing operations as described above. In addition, the driving of the actuators such as the blood pump 4 and the liquid level adjusting pump 11 is controlled by the control means C such as a microcomputer. In particular, the control means C in the present embodiment forms a closed circuit (see the thick line portion in FIG. 6) including the connection positions of the pressure detection means (pressure detection sensors P1 to P4) in the blood circuit, and the blood pump 4 or A self-diagnosis step of diagnosing the quality of the connection state of the blood circuit can be performed based on the detected value of the pressure detecting means that changes by driving the liquid level adjusting pump 11 in the forward direction and pressurizing the closed circuit. It is configured as follows.

  Here, the control means C according to the present embodiment performs a determination process that can determine whether the dialyzer 3 connected to the blood circuit is a wet type or a dry type before the self-diagnosis, and at the time of the self-diagnosis process. The blood circuit connection state is diagnosed according to the type (wet type or dry type) of the dialyzer 3 determined in the determination step. In other words, due to the difference in properties between a compressible gas such as air and an incompressible liquid such as a filling liquid, the dry type dialyzer is better than the wet type dialyzer for pressurization in the self-diagnosis process. Diagnosis by changing the alarm point (threshold value for determining whether connection is good or bad) in the self-diagnosis process according to the type of dialyzer 3 connected to the blood circuit because it is difficult to pressurize and to maintain pressure. To do.

  After the discrimination process and the self-diagnosis process, priming is performed on the condition that the connection is diagnosed as appropriate in the self-diagnosis process. Note that priming refers to a process performed before treatment, in which priming liquid such as dialysate or physiological saline is washed by flowing through the blood flow path or dialysate flow path, and the priming liquid is removed from the blood. This is an operation for prefilling the flow path or the dialysate flow path.

  However, the control means C according to the present embodiment is disposed in the dialysis apparatus main body B, and operates the liquid level adjustment means A when the priming liquid is supplied through the priming liquid supply line L3. 5 is configured so that the height of the liquid surface formed in the inside can be adjusted to an arbitrary position. That is, under the control of the control means C, the clamp means V9 and V10 are opened, and the liquid level adjusting pump 11 is driven to rotate forward so that the air in the arterial air trap chamber 5 or the venous air trap chamber 6 To lower the liquid level or reversely drive the liquid level adjusting pump 11 to discharge air in the arterial air trap chamber 5 or the venous air trap chamber 6 and raise the liquid level. The height of the liquid level of the liquid pool in the artery side air trap chamber 5 or the vein side air trap chamber 6 can be adjusted to an arbitrary position.

Hereinafter, the control content by the control means C according to the present embodiment will be specifically described.
After the blood circuit is connected to the dialyzer main body B, before the blood purification treatment (before dialysis treatment), as shown in FIG. 2, a discrimination step S1, a self-diagnosis step S2, and a priming step S3 are sequentially performed. . The determination step is a step that can determine whether the dialyzer 3 connected to the blood circuit is a wet type or a dry type, and includes a step as shown in FIG. That is, as shown in FIG. 7, after the blood pump 4 is stopped, the clamp means V4, V5, V10, V11 are closed, and then the liquid level adjustment pump 11 is driven in reverse (S1A), thereby the inside of the dialyzer 3 Liquid (filling liquid) or gas (air) is caused to flow to the connection position of the detection means (in this case, bubble detector D3).

  Then, it is determined whether or not the detection means (bubble detector D3) has detected a liquid (S1B). When the liquid is detected, it is determined that the dialyzer 3 connected to the blood circuit is a wet type, and the liquid is detected. When it is not performed (gas is detected), it is determined that the dialyzer 3 connected to the blood circuit is a dry type. Thereby, the bubble detector D3 used during the blood purification treatment can be diverted so that the determination by the determination step can be performed.

  Further, instead of the above embodiment, as shown in FIG. 8, the clamp means V4, V5, V9, V10, V11 are closed while the liquid level adjustment pump 11 is stopped, and then the blood pump 4 is driven in reverse ( By rotating in the reverse direction, the liquid (filling liquid) or gas (air) in the dialyzer 3 may flow to the connection position of the blood concentration detector 12 or the bubble detector D1, which is a detection means. Even in this case, when the blood concentration detector 12 or the bubble detector D1, which is the detection means, detects a liquid, it can be determined as a wet type, and when a gas is detected, it can be determined as a dry type. . As a result, the blood concentration detector 12 or the bubble detector D1 used during the blood purification treatment can be diverted to make a determination in the determination step.

  When the type of dialyzer 3 is determined in the determination step, a self-diagnosis step is performed. Such a self-diagnosis step forms the closed circuit including the connection position of the pressure detection means (pressure detection sensors P1 to P4) in the blood circuit, and changes the pressure detection means ( This is a step of diagnosing the quality of the connection state of the blood circuit based on the detection values of the pressure detection sensors P1 to P4). In particular, in this embodiment, the quality of the connection state of the blood circuit is diagnosed during the self-diagnosis process according to the type of the dialyzer 3 determined in the determination process.

  Specifically, the self-diagnosis process includes a process as shown in FIG. That is, as shown in FIG. 6, the clamp means V2, V4, V5, V11 are closed while the blood pump 4 is stopped to form a closed circuit as shown by the bold line in FIG. Is driven forward (S2A). Thereby, since air is sucked into the closed circuit, the inside of the closed circuit is pressurized. Instead of the liquid level adjustment pump 11, the inside of the closed circuit may be pressurized by driving the blood pump 4 to rotate forward.

  Thereafter, the detected value of the pressure detecting means (pressure detecting sensors P1 to P4) that changes by pressurizing the inside of the closed circuit is monitored, and whether or not the type of the dialyzer 3 connected to the blood circuit is a wet type. (S2B), if it is determined that it is a wet type, the process proceeds to S2C, and the detected value of the monitored pressure detection means (pressure detection sensors P1 to P4) has reached a predetermined pressure within a predetermined time t1 It is determined whether or not.

  If the predetermined pressure is reached within the predetermined time t1, it can be estimated that there is no leakage of the pressurized air at least in the closed circuit, so that the connection of the blood circuit is determined to be appropriate (pass) and the predetermined pressure within the predetermined time t1. If the pressure does not reach, it can be estimated that the pressurized air is leaking at least in the closed circuit, so that the connection of the blood circuit is determined to be inappropriate (failed). In addition, when it is judged as a failure, it is preferable to issue a warning or the like indicating that the connection of the blood circuit is inappropriate.

  On the other hand, if it is determined in S2B that it is not a wet type (that is, a dry type), the process proceeds to S2D, and the detected values of the monitored pressure detection means (pressure detection sensors P1 to P4) are predetermined within a predetermined time t2. It is determined whether the pressure has been reached. At this time, the alarm points t1 and t2 have a relationship of t1 <t2. Thereby, an alarm point can be changed according to the type of dialyzer 3 used, and determination accuracy can be improved.

  If the predetermined pressure is reached within the predetermined time t2, it can be estimated that there is no leakage of the pressurized air at least in the closed circuit, so that the connection of the blood circuit is determined to be appropriate (accepted) and the predetermined pressure within the predetermined time t2. If the pressure does not reach, it can be estimated that the pressurized air is leaking at least in the closed circuit, so that the connection of the blood circuit is determined to be inappropriate (failed). In addition, when it is judged as a failure, it is preferable to issue a warning or the like indicating that the connection of the blood circuit is inappropriate.

  The priming step is for filling the blood circuit with a dialysis solution as a priming solution, and has a step as shown in FIG. That is, as shown in FIG. 9, by connecting the connector a and the connector b, the distal end of the arterial blood circuit 1 and the distal end of the venous blood circuit 2 are connected to form a closed circuit. Then, after the clamping means V1, Va are closed and the clamping means V2, V11 are opened, the blood pump 4 is driven to rotate forward so that the dialysate as the priming liquid is supplied to the closed circuit from the priming liquid supply line L3. Then, a liquid pool is generated in the arterial air trap chamber 5 (S3A).

  Thereafter, it is determined whether or not the blood pump 4 has rotated a predetermined number of times (S3B). When it is determined that the blood pump 4 has rotated a predetermined number of times, the blood pump 4 is driven in reverse while maintaining the open / close state of the clamping means. A liquid pool is generated in the air trap chamber 6 (S3C). Then, the blood pump 4 is stopped and the clamp means V1, V2, V11, Va are opened, and the priming solution (dialysis solution) is overflowed from the overflow line La (S3D: overflow process).

  It is determined whether or not the overflow process (S3D) has passed a predetermined time (S3E). When the predetermined time has passed, the clamp means V11 and Va are closed, the clamp means V1 and V2 are opened, and the blood pump 4 is turned on. The priming liquid is circulated in the closed circuit by rotating in the reverse direction (S3F: circulation step). At this time, the priming liquid flows from the lower blood outlet 3b (blood outlet port) toward the upper blood inlet 3a (blood inlet port) in the blood flow path of the dialyzer 3.

  Then, after the circulation step, it is determined whether or not bubbles are detected by the bubble detectors V1, V2, etc. (S3G). When bubbles are detected, the process returns to S4, and if bubbles are not detected, Proceeding to S3H, a gas purge step (S3H) is performed. The gas purge step (S3H) is a step of filling the dialysate flow path of the dialyzer 3 with the dialysate by driving the dual pump 7 while the clamp means V4 and V5 are opened.

  Thereafter, it is determined whether or not a predetermined time has elapsed (S3I), and when the predetermined time has elapsed, the clamp means V1, V2, V11 and Va are opened to drive the blood pump 4 in the normal direction, thereby driving the blood circuit. Wash with priming solution (S3J). Then, it is determined whether or not the priming liquid supplied from the priming liquid supply line L3 has reached a predetermined amount (S3K). When the predetermined amount has been reached, a series of priming steps is terminated. Thus, the priming process is completed, and blood purification treatment is started.

  According to the above embodiment, the control means C diagnoses the quality of the connection state of the blood circuit according to the type of the dialyzer 3 connected to the blood circuit during the self-diagnosis process, so that the wet type dialyzer 3 or the dry type Whichever dialyzer 3 is selected and used, the self-diagnosis process can be performed with high accuracy. That is, it is possible to change the alarm point, which is the determination criterion, according to the type of dialyzer 3 used, and to improve the determination accuracy.

  Further, the control means C according to the present embodiment causes a determination step to determine whether the dialyzer 3 connected to the blood circuit is a wet type or a dry type, and the dialyzer determined in the determination step. According to the type 3, the quality of the connection state of the blood circuit is diagnosed during the self-diagnosis process, so that the type of the dialyzer 3 can be automatically determined to perform the self-diagnosis process with high accuracy.

  Further, the blood circuit is connected to detection means capable of detecting gas or liquid in the flow path, and the discrimination step drives the liquid level adjustment means 11 or the blood pump 4 to drive the blood flow of the dialyzer 3. Since the gas or liquid in the passage is made to flow to the connection position of the detection means, when the detection means detects the liquid, it is determined to be a wet type, and when the detection means detects gas, it is determined to be a dry type. The type of the dialyzer 3 can be determined more easily and reliably.

  Still further, the artery side air trap chamber 5 connected to the artery side blood circuit 1 and the artery side air trap chamber 5 are connected to the artery side air trap chamber 5 by arbitrarily introducing or discharging air. In addition to the liquid level adjusting means A capable of adjusting the liquid level, the determining step drives the liquid level adjusting means A instead of the blood pump 4 to thereby change the gas or liquid in the blood flow path of the dialyzer 3. Since the flow is made to the connection position of the detection means, the type of the dialyzer 3 can be determined using the liquid level adjustment means A.

  In addition, the liquid level adjusting means A includes a liquid level adjusting pump 11 that can be driven forward and backward, and the control means C drives the liquid level adjusting pump 11 at an arbitrary timing during priming. Since air can be introduced into or discharged from the upper portion of the air trap chamber 5, the type of the dialyzer 3 can be determined more accurately by using the liquid level adjustment pump 11.

  The control means C can adjust the amount of air discharged from the arterial air trap chamber 5 by the liquid level adjustment means A according to the type of the dialyzer 3 connected to the blood circuit during priming, In this case, the liquid level of the artery-side air trap chamber 5 can be appropriately adjusted at low cost regardless of whether the wet type dialyzer 3 or the dry type dialyzer 3 is selected and used.

Next, a blood purification apparatus according to a second embodiment of the present invention will be described.
As in the first embodiment, the blood purification apparatus according to the present embodiment is composed of a dialysis apparatus for performing dialysis treatment. As shown in FIG. 16, the blood is composed of an arterial blood circuit 1 and a venous blood circuit 2. A circuit, a dialyzer 3 interposed between the arterial blood circuit 1 and the venous blood circuit 2 to purify blood flowing through the blood circuit, and a squeezing blood pump 4 disposed in the arterial blood circuit 1 The artery side air trap chamber 5 connected to the artery side blood circuit 1, the vein side air trap chamber 6 connected to the vein side blood circuit 2, the priming liquid supply line L3, the liquid level adjusting means A, the control It is mainly composed of means C. In addition, the same code | symbol is attached | subjected to the component similar to 1st Embodiment, and those detailed description is abbreviate | omitted.

  Here, the blood concentration detector 12 and the bubble detector D3 as detection means in the present embodiment are connected to the venous blood circuit 2. In the determination step, the liquid (4) in the dialyzer 3 is driven forward by driving the blood pump 4 forward while the clamp means V1, V2 are opened and the clamp means V4, V5, V9, V10, V11 are closed. Filling liquid) or gas (air) is caused to flow to the connection position of the detection means (in this case, blood concentration detector 12 or bubble detector D3).

  Then, it is determined whether or not the detection means (blood concentration detector 12 or bubble detector D3) has detected a liquid, and when the liquid is detected, it is determined that the dialyzer 3 connected to the blood circuit is a wet type, When no liquid is detected (gas is detected), it is determined that the dialyzer 3 connected to the blood circuit is a dry type. As a result, the blood concentration detector 12 or the bubble detector D3 used during the blood purification treatment can be diverted to make a determination in the determination step.

  In this way, the control means C performs a determination step that can determine whether the dialyzer 3 connected to the blood circuit is a wet type or a dry type, and in the determination step as in the first embodiment. According to the determined type of the dialyzer 3, the blood circuit connection state is diagnosed during the self-diagnosis process. Therefore, the self-diagnosis process can be performed with high accuracy regardless of whether the wet type dialyzer 3 or the dry type dialyzer 3 is selected and used.

  Although the present embodiment has been described above, the present invention is not limited thereto. For example, as shown in FIG. 17, one end is connected to the arterial blood circuit 1 instead of the priming fluid supply line L3. In addition, the present invention may be applied to a blood purification apparatus including a priming liquid supply line L12 having the other end connected to the storage bag F. In this case, the accommodation bag F contains a predetermined amount of physiological saline as a priming solution, and the saline in the accommodation bag F is transferred to the arterial blood circuit 1 by opening the clamp means V11. It is comprised so that it may be supplied to. In addition, in the same figure, the code | symbol d has shown the chamber connected to the priming liquid supply line L12.

  However, in the discrimination step according to the present embodiment, the gas or liquid in the blood flow path of the dialyzer 3 is detected by means for detecting (bubble detectors (D1, D2, D3), blood concentration detector 12, blood discriminator 13). Although it is supposed to be detected, as long as the dialyzer 3 (blood purification means) connected to the blood circuit can determine whether it is a wet type or a dry type, it may be of other forms Good.

  Further, in the present embodiment, the determination step is performed by the control means C, and the quality of the connection state of the blood circuit is diagnosed during the self-diagnosis step according to the type of the dialyzer 3 determined in the determination step. However, instead of this, for example, the type of the dialyzer 3 used by an operator or the like during blood purification treatment is input, and the connection state of the blood circuit is determined according to the input type of the dialyzer 3 You may make it diagnose.

  Furthermore, the liquid level adjusting means A may be provided in the dialyzer main body B, or may be provided in a position different from the dialyzer main body B, and further the liquid level adjusting means. A that does not include A may be used. In this embodiment, the present invention is applied to a dialysis apparatus used at the time of hemodialysis treatment, but other apparatuses that can purify the patient's blood while circulating it outside the body (for example, blood filtration dialysis, blood filtration, AFBF) You may apply to the blood purification apparatus used, a plasma adsorption apparatus, etc.).

The control means performs a determination step capable of determining whether the blood purification means connected to the blood circuit is a wet type or a dry type, and according to the type of the blood purification means determined in the determination step. , when the self-diagnosis process, if the blood purification apparatus for diagnosing the quality of the connection state of the blood circuit, can be applied to such one having other functions.

1 Arterial blood circuit 2 Venous blood circuit 3 Dialyzer (blood purification means)
DESCRIPTION OF SYMBOLS 4 Blood pump 5 Arterial side air trap chamber 6 Vein side air trap chamber 7 Duplex pump 8, 9 Filtration filter 10 Dewatering pump 11 Liquid level adjustment pump 12 Blood concentration detector (detection means)
13 Blood discriminator D1-D3 Bubble detector P1-P4 Pressure detection sensor (pressure detection means)
L1 Dialysate introduction line L2 Dialysate discharge line L3, L12 Priming fluid supply line A Liquid level adjustment means B Dialyzer main body C Control means

Claims (8)

A blood circuit comprising an arterial blood circuit and a venous blood circuit, and capable of extracorporeally circulating the patient's blood from the distal end of the arterial blood circuit to the distal end of the venous blood circuit;
A blood flow path and dialysate that are interposed between the arterial blood circuit and the venous blood circuit of the blood circuit to purify blood flowing through the blood circuit and through which the patient's blood flows through the blood purification membrane Blood purification means in which a flowing dialysate flow path is formed;
A blood pump disposed in the arterial blood circuit;
A pressure detecting means connected to a predetermined channel and capable of detecting the pressure of the channel;
In the blood circuit, a closed circuit is formed including the connection position of the pressure detection means, and whether the connection state of the blood circuit is good or not based on a detection value of the pressure detection means that changes by pressurizing the inside of the closed circuit Control means capable of performing a self-diagnosis process for diagnosing
The blood purification means is connected to the blood circuit by either a wet type in which the blood flow path and the dialysate flow path are pre-filled with a filling liquid, or a dry type in which the filling liquid is not filled. A blood purification apparatus for performing blood purification treatment,
The control means performs a determination step capable of determining whether the blood purification means connected to the blood circuit is a wet type or a dry type, and determines the type of the blood purification means determined in the determination step. Correspondingly, when the self-diagnosis step, before Symbol blood purification apparatus characterized by diagnosing the quality of the connection state of the blood circuit. The blood circuit is connected to detection means capable of detecting gas or liquid in the flow path, and the discrimination step drives the blood pump so that the gas in the blood flow path of the blood purification means. Alternatively, the liquid is caused to flow to the connection position of the detection means, and when the detection means detects the liquid, it is determined that the liquid is wet, and when the detection means detects gas, it is determined that the liquid is dry. The blood purification apparatus according to claim 1 . The detection means is connected between the blood purification means and the artery side air trap chamber, and can detect a gas in the blood flowing from the artery side blood circuit to the blood purification means during the blood purification treatment, and the discrimination The blood purification apparatus according to claim 2, comprising a bubble detector capable of detecting gas or liquid in the process. The detection means is connected to the distal end portion of the arterial blood circuit or the distal end portion of the venous blood circuit, and can detect gas in blood flowing through the arterial blood circuit or venous blood circuit during blood purification treatment. The blood purification apparatus according to claim 2 , further comprising a bubble detector capable of detecting gas or liquid in the discrimination step. The detection means is connected to the arterial blood circuit or the venous blood circuit, and can detect the concentration of blood flowing through the arterial blood circuit or the venous blood circuit during blood purification treatment, and in the determination step The blood purification apparatus according to claim 2, comprising a blood concentration detector capable of detecting gas or liquid. An arterial air trap chamber connected to the arterial blood circuit;
A liquid level adjusting means connected to the artery side air trap chamber and capable of adjusting the liquid level by arbitrarily introducing or discharging air to the artery side air trap chamber;
And the determination step causes the gas or liquid in the blood flow path of the blood purification means to flow to the connection position of the detection means by driving the liquid level adjustment means instead of the blood pump. The blood purification apparatus according to claim 2 . The liquid level adjusting means includes a liquid level adjusting pump that can be driven forward and backward, and the control means drives the liquid level adjusting pump at an arbitrary timing during the priming to cause the arterial air trap. 7. The blood purification apparatus according to claim 6, wherein air can be introduced into or discharged from the upper part of the chamber. 8. The control unit according to claim 1, wherein the control unit changes a threshold value for determining whether the connection state of the blood circuit is good or not according to the type of the blood purification unit determined in the determination step. The blood purification apparatus according to one.

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