Hemodialysis device including fluid replacement line, and method for detecting reverse connection of fluid replacement line

Abstract

The present disclosure provides a hemodialysis device and a detection method therefor that enable detection of reverse connection of a fluid replacement line to a replenishing pump. A hemodialysis device (100) according to the present disclosure includes a venous pressure sensor (112f) that measures the pressure of a gas in a vein chamber (112b) as a venous pressure. A control device (160) causes a determination unit to determine whether a fluid replacement line (140) is reversely connected to a replenishing pump (140a) on the basis of a variation in venous pressure caused by rotation of the replenishing pump (140a) in a state where a flow path upstream of a portion of the fluid replacement line (140) which is attached to the replenishing pump (140a) is open to a dialysate circuit (130), a flow path downstream of the portion of the fluid replacement line (140) which is attached to the replenishing pump (140a) is open to a blood circuit (110), and any section of a flow path downstream of the vein chamber (112b) is closed.

Description

Hemodialysis machine including a fluid replacement line, and method for detecting reversed front-to-rear connection of the fluid replacement line

[0001] The present invention relates to a hemodialysis machine including a fluid replacement line, and a method for detecting reversed front-to-rear connection of the fluid replacement line.

[0002] A hemodialysis machine includes a blood purifier, a blood circuit, a dialysate circuit, a hemodialysis machine main body (also called a console), and other components. Recently, in order to perform online hemodiafiltration therapy, rapid fluid replacement, and other procedures, hemodialysis machines are sometimes equipped with fluid replacement lines for injecting replacement fluid into the blood circuit (see Patent Document 1). The fluid replacement line is used, for example, to supply replacement fluid to the blood circuit when blood pressure drops during dialysis treatment. These circuits are assembled before treatment and connected or attached to the console. Then, priming is performed on each circuit to remove air from the circuit and clean the circuit.

[0003] Patent No. 5681536

[0004] To supply the appropriate amount of replacement fluid to the blood circuit, it is also important that the replacement fluid line is properly attached to the replacement fluid pump. Specifically, the replacement fluid pump is a roller pump that squeezes the circuit (tube) to send fluid. If the replacement fluid line is attached to the replacement fluid pump with the replacement fluid inlet and outlet reversed (hereinafter referred to as "reverse attachment"), replacement fluid cannot be supplied, and there is a risk of overhydration.

[0005] The present invention provides a hemodialysis machine capable of detecting whether a replacement fluid line is connected backwards to a replacement fluid pump, and a detection method thereof.

[0006] and a control device including: a blood purifier having a blood purification membrane therein; a dialysate circuit; a blood circuit including an arterial line and a venous line including a venous chamber; a venous pressure sensor that measures the pressure of gas in the venous chamber as venous pressure; a replacement fluid line that supplies the dialysate from the dialysate circuit to the blood circuit as a replacement fluid; a replacement fluid pump to which the replacement fluid line is attached; a control unit that controls operation of the replacement fluid pump; and a determination unit that determines whether the replacement fluid line is reversed front to back to the replacement fluid pump, wherein the determination unit determines whether the replacement fluid line is reversed front to back based on fluctuations in the venous pressure caused by rotating the replacement fluid pump while a flow path of the replacement fluid line upstream of a portion attached to the replacement fluid pump is open to the dialysate circuit, a flow path of the replacement fluid line downstream of a portion attached to the replacement fluid pump is open to the blood circuit, and any portion of the flow path downstream of the venous chamber is blocked.

[0007] In one aspect, the present disclosure provides a method for detecting reverse front-to-reverse connection of a replacement fluid line of a hemodialysis device, the method comprising: a blood purifier having a blood purification membrane therein; a dialysate circuit; a blood circuit including an arterial line and a venous line including a venous chamber; a venous pressure sensor that measures the pressure of gas in the venous chamber as venous pressure; a replacement fluid line that supplies the dialysate from the dialysate circuit to the blood circuit as a replacement fluid; a replacement fluid pump to which the replacement fluid line is attached; and a control device including a control unit that controls the operation of the replacement fluid pump and a determination unit that determines whether the replacement fluid line is reversed front-to-reverse to the replacement fluid pump, The present invention relates to a method for detecting reversed front-to-rear connection of a replacement fluid line of a hemodialysis apparatus, in which a flow path upstream of a portion of the replacement fluid line attached to the replacement fluid pump is opened to the dialysis fluid circuit, a flow path downstream of a portion of the replacement fluid line attached to the replacement fluid pump is opened to the blood circuit, and any part of the flow path downstream of the venous chamber is blocked, and the determination unit determines whether the reversed front-to-rear connection is present or not based on fluctuations in the venous pressure caused by rotating the replacement fluid pump.

[0008] According to the present invention, it is possible to provide a hemodialysis machine and a detection method capable of detecting whether a replacement fluid line is connected backwards to a replacement fluid pump.

[0009] FIG. 1 is a schematic diagram illustrating the priming process in a hemodialysis apparatus according to one embodiment of the present invention. FIG. 2 is a schematic diagram illustrating the priming process in a hemodialysis apparatus according to one embodiment of the present invention. FIG. 3 is a schematic diagram illustrating the priming process in a hemodialysis apparatus according to one embodiment of the present invention. FIG. 4 is a block diagram illustrating the configuration of a hemodialysis apparatus according to one embodiment of the present invention. FIG. 5 is a schematic diagram of a venous chamber constituting a hemodialysis apparatus according to one embodiment of the present invention. FIG. 6 is a flow chart illustrating an example of a priming process in a hemodialysis apparatus according to one embodiment of the present invention. FIG. 7 is a flowchart illustrating the determination of whether a replacement fluid line is attached to a substitution fluid pump (forward rotation) in reverse order according to one embodiment of the present invention. FIG. 8 is a flowchart illustrating the determination of whether a replacement fluid line is attached to a substitution fluid pump (reverse rotation) in reverse order according to one embodiment of the present invention. FIG. 9 is a schematic diagram illustrating the state in which a replacement fluid line is attached to a substitution fluid pump in forward rotation and the substitution fluid pump is rotated forward for the determination in a detection method according to one embodiment of the present invention. Fig. 10 is a schematic diagram illustrating a state in which a replacement fluid line is attached to a replacement fluid pump in the correct order and the replacement fluid pump is rotated in reverse for the determination in a detection method according to one embodiment of the present invention. Fig. 11 is a schematic diagram illustrating a state in which a replacement fluid line is attached to a replacement fluid pump in reverse order and the replacement fluid pump is rotated forward for the determination in a detection method according to one embodiment of the present invention. Fig. 12 is a schematic diagram illustrating a state in which a replacement fluid line is attached to a replacement fluid pump in reverse order and the replacement fluid pump is rotated in reverse for the determination in a detection method according to one embodiment of the present invention.

[0010] In the above-described hemodialysis apparatus of the present invention or the method for detecting reversed front-to-rear connection of a replacement fluid line of a hemodialysis apparatus of the present invention (hereinafter also referred to as the "detection method of the present invention"), "reverse front-to-rear connection" means that the replacement fluid line is attached to the replacement fluid pump so that the replacement fluid inlet and outlet sides are reversed. On the other hand, "ordered front-to-rear connection" means that the replacement fluid line is attached to the replacement fluid pump while the replacement fluid inlet and outlet sides remain in the same order. The "inlet side" refers to the upstream side of the dialysate flow when dialysate is supplied from the dialysate circuit to the blood circuit as replacement fluid, and the "outlet side" refers to the downstream side. In this specification, "upstream side" and "downstream side" refer to the direction of fluid flow during treatment using the hemodialysis apparatus of the present invention.

[0011] In the detection method of the present invention, a location in the flow path downstream of the venous chamber is blocked to form a closed circuit in the flow path including the venous pressure chamber, and a substitution fluid pump attached to the closed circuit is rotated to determine whether the front-to-reverse connection is present. The gas pressure in the venous pressure chamber, measured as venous pressure, fluctuates depending on whether the front-to-reverse connection is present. One end of the closed circuit is a location in the flow path downstream of the venous chamber, and the other end is a dialysate delivery unit. For example, if the hemodialysis device of the present invention does not include a drain line connected to the venous line for discharging dialysate as a priming solution, the location in the flow path downstream of the venous chamber may be a location in the venous line downstream of the venous chamber. If the hemodialysis device of the present invention includes the drain line and a priming clamp for opening and closing the drain line, the location in the flow path downstream of the venous chamber may be, for example, a location in the drain line.

[0012] When the substitution fluid pump is rotated forward for the above-mentioned determination, if the substitution fluid line is connected to the substitution fluid pump in the forward-backward direction, the dialysate in the substitution fluid line as the priming fluid is sent to the blood circuit, and the venous pressure measured by the venous pressure sensor increases. On the other hand, if the substitution fluid line is connected in the reverse direction, the dialysate in the blood circuit as the priming fluid is sent to the substitution fluid line, and the venous pressure measured by the venous pressure sensor decreases. When the substitution fluid pump is rotated backward for the above-mentioned determination, if the substitution fluid line is connected to the substitution fluid pump in the forward-backward direction, the dialysate in the blood circuit as the priming fluid is sent to the substitution fluid line, and the venous pressure measured by the venous pressure sensor decreases. On the other hand, if the substitution fluid line is connected in the reverse direction, the dialysate in the substitution fluid line as the priming fluid is sent to the blood circuit, and the venous pressure measured by the venous pressure sensor increases. Note that forward rotation refers to the rotation direction that allows the supply of dialysate to the blood circuit, and reverse rotation refers to the rotation direction opposite to that.

[0013] In one aspect, the hemodialysis apparatus and the detection method of the present invention are configured to perform the determination by rotating the replacement fluid pump in a forward direction and detecting the venous pressure P ｙ From the above, the venous pressure P before the rotation of the replacement fluid pump ０ The difference (P ｙ -P ０ When the difference (P ｙ -P ０ ) is less than the threshold value A, the determining unit may determine that the replacement fluid line is connected to the replacement fluid pump in the reversed front-to-back direction. Alternatively, it is preferable to determine that the venous pressure P ｘ to the venous pressure P before the replacement fluid pump rotates ０ The difference (P ｘ -P ０ If Y is less than the threshold value A, the determination unit determines that the replacement fluid line is attached to the replacement fluid pump in the reversed order. However, Y and X satisfy the relationship Y<X. With this configuration, it is possible to accurately determine whether the replacement fluid line is attached in the reversed order.

[0014] In one aspect, the hemodialysis apparatus and the detection method of the present invention are configured to reversely rotate the replacement fluid pump for the determination, and measure the venous pressure P during Y rotation of the replacement fluid pump. ｙ From the above, the venous pressure P before the rotation of the replacement fluid pump ０ The difference (P ｙ -P ０ When the difference (P) becomes equal to or smaller than a threshold value B preset in the determination unit, the determination unit determines that the replacement fluid line is connected to the replacement fluid pump in a front-to-back order. ｙ -P ０ ) is greater than the threshold B, the determining unit may determine that the replacement fluid line is connected to the replacement fluid pump in the reversed direction. Alternatively, it is preferable to determine that the venous pressure P ｘ to the venous pressure P before the replacement fluid pump rotates ０ The difference (P ｘ -P ０ ) is greater than the threshold B, the determination unit determines that the replacement fluid line is attached to the replacement fluid pump in a reversed front-to-back direction. However, the relationship between Y and X is Y<X. With this configuration, it is possible to accurately determine whether the replacement fluid line is attached in a reversed front-to-back direction.

[0015] The threshold value A is preferably set to a value obtained by rotating the replacement fluid pump in the forward direction with the replacement fluid line connected to the replacement fluid pump in the forward direction and calculating the venous pressure P ｘ From the above, the venous pressure P before the rotation of the replacement fluid pump for the determination ０ The difference (P ｘ -P ０ ) is set to a value smaller than

[0016] Preferably, the threshold value B is determined by rotating the replacement fluid pump in reverse with the replacement fluid line connected to the replacement fluid pump in a forward and backward order, and calculating the venous pressure P ｘ From the above, the venous pressure P before the rotation of the replacement fluid pump for the determination ０ The difference (P ｘ -P ０ ) is set to a value greater than

[0017] The determination of whether or not the front-to-reverse connection is present is preferably made after the blood circuit and the replacement fluid line are filled with the dialysis fluid as a priming fluid.

[0018] In one aspect of the hemodialysis apparatus and the detection method of the present invention, the dialysis circuit includes a dialysate inlet line that supplies dialysate to the blood purifier and a dialysate inlet flow path on-off valve that can open and close the flow path of the dialysate inlet line. The dialysis circuit also includes a dialysate outlet line through which dialysate discharged from the blood purifier flows and a dialysate outlet flow path on-off valve that can open and close the flow path of the dialysate outlet line. Preferably, the substitution fluid pump is rotated for the determination with the flow path of the dialysate inlet line blocked by the dialysate inlet flow path on-off valve or with the flow path of the dialysate outlet line blocked by the dialysate outlet flow path on-off valve. This is preferable to a state in which both the dialysate inlet flow path on-off valve and the dialysate outlet flow path on-off valve are open, because this provides better responsiveness to changes in venous pressure when the substitution fluid pump is rotated for the determination.

[0019] In one aspect, the hemodialysis apparatus and the detection method of the present invention preferably include a substitution fluid clamp that opens and closes the flow path of the substitution fluid line downstream of the portion of the substitution fluid line that is attached to the substitution fluid pump.

[0020] In one aspect of the hemodialysis apparatus and the detection method of the present invention, the hemodialysis apparatus includes an alarm, and when the determination indicates that the replacement fluid line is connected to the replacement fluid pump in the reversed order, the controller activates the alarm to notify the operator. This configuration reduces the burden of attention on an operator preparing for dialysis treatment.

[0021] Hereinafter, preferred embodiments of the hemodialysis apparatus of the present invention and the detection method of the present invention will be described in detail with reference to the drawings.

[0022] Fig. 1 is a diagram showing a schematic configuration of one embodiment of the hemodialysis apparatus of the present invention, and Fig. 4 is a block diagram showing the configuration of the hemodialysis apparatus shown in Fig. 1. The hemodialysis apparatus 100 of this embodiment is configured to purify the blood of patients with renal failure or drug addiction, remove excess water from the blood, and replenish the blood with dialysate as a replacement fluid as needed.

[0023] The hemodialysis machine 100 is an automatic dialysis machine that automatically and continuously performs each of the steps described below, such as a priming step, a blood removal step, a fluid replacement step, and a blood return step, by controlling the flow of dialysate in the circuit. In one aspect, the detection method of the present invention, which is performed using the hemodialysis machine of the present invention, can be applied to the priming step.

[0024] 1 and other figures, the hemodialysis machine 100 includes a blood purifier 120, a blood circuit 110, an overflow line (drain line) 113, a dialysate circuit 130, a replacement fluid line 140, and a ventilation line 112e connected to a venous chamber 112b constituting the blood circuit 110. The hemodialysis machine 100 also includes a hemodialysis machine main body (hereinafter also referred to as a "console") C including a venous pressure sensor 112f attached to the ventilation line 112e, a control device 160, and an alarm 150.

[0025] The blood purifier 120 is a conventionally known device, such as a dialyzer or a hemodiafilter. A hollow fiber bundle (not shown), which functions as a blood purification membrane, is housed inside a cylindrical container body 121. The hollow fiber bundle divides the interior of the container body 121 into an inside and an outside of the hollow fibers, with the inside of the hollow fibers being a blood flow path and the outside of the hollow fibers being a dialysate flow path. The container body 121 is formed with a blood inlet 122a and a blood outlet 122b that communicate with the blood circuit 110, and a dialysate inlet 123a and a dialysate outlet 123b that communicate with the dialysate circuit 130.

[0026] The blood circuit 110 is a circuit for circulating the patient's blood, and is mainly composed of transparent, soft tubes that are flexible enough to allow fluid to flow through. The blood circuit 110 includes an arterial line 111 and a venous line 112.

[0027] The arterial line 111 has one end connected to the blood inlet 122a of the blood purifier 120, and the other end includes an arterial connection part 111a to which a blood removal needle (not shown) can be connected to be inserted into the patient's blood vessel (artery).

[0028] An arterial air bubble detector 111c and a blood pump 111b are attached to the arterial line 111. The arterial air bubble detector 111c is disposed closer to the arterial connection part 111a than the blood pump 111b and detects the presence or absence of air bubbles in the arterial line 111. The detection result is transmitted to the control part 161 (see FIG. 4 ) of the control device 160. A fluid replacement line connection port 111d, to which the downstream end of the fluid replacement line 140 is connected, is provided in the arterial line 111, for example, downstream of the part attached to the blood pump 111b (a part closer to the blood inlet 122a of the blood purifier 120).

[0029] The blood pump 111b pumps out liquids such as blood and priming solution from inside the arterial line 111 by squeezing the soft tube that constitutes the arterial line 111 with a roller. The blood pump 111b is controlled by the control device 160, and its rotation direction, rotation speed, etc. can be changed.

[0030] The venous line 112 has one end connected to the blood outlet 122b of the blood purifier 120, and the other end including a venous connection portion 112a to which a blood return needle (not shown) can be connected to be inserted into the patient's blood vessel (vein).

[0031] The venous line 112 includes a venous chamber 112b, to which a venous air bubble detector 112c and an air bubble detector clamp 112d are attached. The venous chamber 112b stores a predetermined amount of blood, for example, approximately 20 ml, to remove air bubbles and coagulated blood that may have entered the venous line 112. The venous air bubble detector 112c is located downstream of the venous chamber 112b (toward the venous connection portion 112a) and detects the presence or absence of air bubbles in the tube. The detection result is transmitted to the control unit 161 of the control device 160.

[0032] The air bubble detector clamp 112d is disposed downstream of the venous air bubble detector 112c (toward the venous connection portion 112a). The opening and closing of the air bubble detector clamp 112d is controlled by the control unit 161 of the control device 160 in response to the result of air bubble detection by the venous air bubble detector 112c. The air bubble detector clamp 112d is closed when air bubbles are detected by the venous air bubble detector 112c and is normally open. The air bubble detector clamp 112d may also serve as a venous line clamp that can open and close the flow path of the venous line downstream of the venous chamber 112b under the control of the control unit 161 when air bubbles are not detected. Examples of times when air bubbles are not detected include when the replacement fluid pump 140a is rotating to determine whether the replacement fluid line 140 is reversed forward and backward relative to the replacement fluid pump 140a, and during automatic priming by backfiltration, as described below.

[0033] As shown in Figure 5, venous chamber 112b includes a chamber main body 1120b for containing a liquid, an inlet 1121b connected to a portion of venous line 112 upstream of venous chamber 112b for introducing the liquid into chamber main body 1120b, a vent 1122b for gas inflow and outflow, an outlet 1123b for discharging the liquid in venous chamber 112b to overflow line 113, and an outlet 1124b formed at the bottom of chamber main body 1120b for discharging the liquid in venous chamber 112b to venous line 112 downstream of venous chamber 112b. One end of ventilation line 112e is connected to vent 1122b. A venous pressure sensor 112f (see Figure 1) is attached to the other end of ventilation line 112e, for example, to measure the pressure of the gas in venous chamber 112b and ventilation line 112e as venous pressure.

[0034] The venous pressure sensor 112f measures the air pressure in the space 1125b within the chamber main body 1120b and the vent line 112e connected thereto as venous pressure, which fluctuates with the rise or fall of the liquid level stored in the chamber main body 1120b. As the liquid level in the chamber main body 1120b rises, the venous pressure rises, and as the liquid level falls, the venous pressure falls. The venous pressure sensor 112f, for example, constitutes the hemodialysis apparatus main body C, and the other end of the vent line 112e includes a connection site (not shown) with the venous pressure sensor 112f. The venous pressure sensor 112f is a well-known device configured to continuously output venous pressure at short intervals, for example, several times per second. The output result from the venous pressure sensor 112f is transmitted to and recorded by, for example, the determination unit 162 of the control device 160.

[0035] The arterial connecting portion 111a and the venous connecting portion 112a can be directly connected to each other without going through the human body, ie, can be placed in a so-called short-circuit state (bypass connection state).

[0036] An overflow line (also referred to as a "drainage line") 113 is connected to the venous chamber 112b that constitutes the venous line 112. A priming clamp 113a is attached to the overflow line 113. The overflow line 113 is a line for draining the priming solution during the priming process. The priming clamp 113a is controlled by the control unit 161 of the control device 160 and can be switched between a closed state in which the flow path of the overflow line 113 is blocked and an open state in which it is opened. Note that the hemodialysis apparatus of the present invention may not include the overflow line 113, and the portion of the venous line 112 downstream of the venous chamber 112b can also function as a drainage line. Specifically, the arterial connection part 111a and the venous connection part 112a are disconnected to drain the priming solution from the venous line 112. In this case, it is preferable that the air bubble detector clamp 112d or a separately provided venous line clamp (not shown), preferably the air bubble detector clamp 112d, be controlled by the control unit 161 to perform the same function as the priming clamp 113a.

[0037] Blood extracted from the artery of a subject (dialysis patient) flows through the arterial line 111 by the forward rotation of the blood pump 111b and is introduced into the blood flow path of the blood purifier 120. The blood introduced into the blood purifier 120 is purified by the dialysate flowing through the dialysate circuit 130 (described later) via a blood purification membrane. The blood purified in the blood purifier 120 flows through the venous line 112 and is returned to the subject's veins.

[0038] The dialysate circuit 130 is a circuit for supplying and discharging dialysate to and from the blood purifier 120. In this embodiment, a so-called double-chamber sealed volume control method is adopted as the water removal amount control method, and the dialysate circuit 130 includes a dialysate delivery unit 133 including a dialysate chamber 1331 as the double chamber, a dialysate supply line 131a and a dialysate introduction line 132a connected to each other via a supply liquid storage unit 1331a (one chamber) of the dialysate chamber 1331, and a dialysate discharge line 131b and a dialysate withdrawal line 132b connected to each other via a waste liquid storage unit 1331b (the other chamber) of the dialysate chamber 1331. The dialysate is discharged from this sealed circuit by a water removal / backfiltration pump 135, thereby controlling the water removal amount.

[0039] The dialysate delivery unit 133 further includes a dialysate introduction pump 1332 and a dialysate discharge pump 1333. The dialysate introduction pump 1332 delivers the dialysate in the supply solution storage unit 1331a to the hemodialyzer 120, and the dialysate discharge pump 1333 delivers the dialysate discharged from the hemodialyzer 120 to the discharge solution storage unit 1331b. By controlling the dialysate introduction pump 1332 and the dialysate discharge pump 1333, the dialysate can be delivered to the blood purifier 120 so as to apply negative or positive pressure to the blood purification membrane. The dialysate introduction pump 1332 and the dialysate discharge pump 1333 are, for example, gear pumps that deliver liquid by rotating gears. The dialysate introduction pump 1332 and the dialysate discharge pump 1333 are controlled by the control unit 161 of the control device 160, and their rotation direction, rotation speed, etc. can be changed.

[0040] The dialysis fluid chamber 1331 is used to temporarily store dialysis fluid and is composed of a hard container that can hold a certain volume of dialysis fluid (e.g., 300 ml to 500 ml). The interior of this container is divided into a supply fluid storage section 1331a and a drainage fluid storage section 1331b by a soft diaphragm.

[0041] After the priming start button is pressed, the dialysate delivery unit 133 operates constantly, except when delivery is stopped due to an alarm or the like, and circulates the dialysate within the dialysate circuit 130. The dialysate delivery unit 133 is not limited to the configuration shown in Fig. 1, and may be a conventionally known dialysate delivery unit that uses a sealed volume control system, and may include, for example, two or more fixed-volume containers divided into two small chambers and three or more gear pumps.

[0042] The dialysate circuit 130 includes a bypass line 134 connecting the dialysate outlet line 132b and the dialysate drain line 131b, and the bypass line 134 includes a water removal / backfiltration pump 135.

[0043] The water removal / backfiltration pump 135 can send the dialysate in the bypass line 134 in both a direction (water removal direction) that circulates the dialysate toward the dialysate discharge line 131b and a direction (backfiltration direction) that circulates the dialysate toward the dialysate outlet line 132b. The water removal / backfiltration pump 135 is, for example, a plunger pump that rotates a plunger to send the liquid. The water removal / backfiltration pump 135 is controlled by the control unit 161 of the control device 160, and its rotation direction, rotation speed, etc. can be changed.

[0044] One end of the dialysate supply line 131a is connected to a dialysate supply device (not shown), and the other end is connected to the supply fluid storage unit 1331a. The dialysate supply line 131a supplies fresh dialysate to the supply fluid storage unit 1331a.

[0045] The dialysate circuit 130 includes a dialysate introduction line 132a that supplies fresh dialysate to the blood purifier 120. One end of the dialysate introduction line 132a is connected to a supply fluid storage section 1331a, and the other end is connected to a dialysate inlet 123a of the blood purifier 120, thereby introducing the dialysate stored in the supply fluid storage section 1331a into the dialysate flow path of the blood purifier 120. A solenoid valve that opens and closes the flow path is installed in the dialysate introduction line 132a as a dialysate introduction flow path opening / closing valve 133a. The opening and closing of the dialysate introduction flow path opening / closing valve 133a is controlled by a control section 161 of the control device 160. In addition, the upstream end of an upstream replacement fluid line 140f (described later) is connected to the dialysate introduction line 132a.

[0046] One end of the dialysate outlet line 132b is connected to the dialysate outlet 123b of the blood purifier 120, and the other end is connected to the waste fluid storage section 1331b, so that the dialysate discharged from the blood purifier 120 is led to the waste fluid storage section 1331b. A solenoid valve that opens and closes the flow path of the dialysate outlet line 132b is arranged in the middle of the dialysate outlet line 132b as a dialysate outlet flow path opening / closing valve 133b. The opening and closing of the dialysate outlet flow path opening / closing valve 133b is controlled by the control section 161 of the control device 160.

[0047] The dialysate discharge line 131b has one end connected to the waste fluid storage section 1331b, and the other end from which the used dialysate stored in the waste fluid storage section 1331b is discharged.

[0048] By controlling the dialysate delivery unit 133 by the control unit 161, the amount of fresh dialysate supplied from a dialysate supply device (not shown) to the supply solution storage unit 1331a and the amount of used dialysate collected in the waste solution storage unit 1331b can be made equal. For example, when the dialysate introduction pump 1332 and the dialysate discharge pump 1333 deliver the same amount of solution (ml) and the water removal / backfiltration pump 135 and the replacement solution pump 140a (described later) are stopped, the flow rate of the dialysate introduced into the blood purifier 120 and the amount of dialysate (waste solution) discharged from the blood purifier 120 become equal.

[0049] [Backfiltration] When the water removal / backfiltration pump 135 is driven to flow the dialysate in the backfiltration direction, a portion of the effluent discharged from the effluent storage portion 1331b to the dialysate discharge line 131b passes through the bypass line 134 and the dialysate outlet line 132b and is collected again in the effluent storage portion 1331b. Therefore, the amount of dialysate discharged from the blood purifier 120 is the amount that should be collected in the effluent storage portion 1331b when the water removal / backfiltration pump 135 is not driven (i.e., the amount of dialysate flowing through the dialysate inlet line 132a) minus the amount of dialysate flowing through the bypass line 134. In other words, the amount of dialysate discharged from the blood purifier 120 is less than the flow rate of dialysate flowing through the dialysate inlet line 132a by the amount of dialysate (effluent) that passes through the bypass line 134 and is collected again in the effluent storage portion 1331b. Therefore, when the water removal / back-filtration pump 135 is driven to circulate the dialysis fluid in the back-filtration direction, a predetermined amount of dialysis fluid is injected (back-filtered) into the blood circuit 110 in the blood purifier 120.

[0050] [Water Removal] On the other hand, when the water removal / backfiltration pump 135 is driven to flow the dialysate in the water removal direction, the amount of dialysate flowing through the dialysate outlet line 132b is the sum of the amount of dialysate collected in the effluent storage section 1331b when the water removal / backfiltration pump 135 is not driven (i.e., the amount equal to the amount of dialysate flowing through the dialysate inlet line 132a) and the amount of dialysate flowing through the bypass line 134. In other words, the amount of dialysate flowing through the dialysate outlet line 132b is greater than the amount of dialysate flowing through the dialysate inlet line 132a by the amount of dialysate (effluent) discharged through the bypass line 134 to the dialysate drain line 131b. Therefore, when the water removal / backfiltration pump 135 is driven to flow the dialysate in the water removal direction, a predetermined amount of water is removed from the blood in the blood purifier 120.

[0051] The replacement fluid line 140 is a line for supplying dialysate as a substitution fluid or priming fluid from the dialysate circuit 130 to the blood circuit 110. The dialysate is supplied from the dialysate circuit 130, which serves as a substitution fluid supply source. The replacement fluid line 140 includes an upstream replacement fluid line 140f built into the console C and a downstream replacement fluid line 140g arranged outside the console C. The upstream replacement fluid line 140f is connected to, for example, the dialysate introduction line 132a of the dialysate circuit 130. The downstream replacement fluid line 140g is connected to the upstream replacement fluid line 140f via a connection port 140e provided on the console C during assembly of the hemodialysis apparatus 100, which will be described later.

[0052] A solenoid valve (replenishment fluid flow path on-off valve) 140d for opening and closing the flow path of the upstream replacement fluid line 140f and a pressure sensor 140c for measuring the fluid pressure in the upstream replacement fluid line 140f are attached to the upstream replacement fluid line 140f in this order from the upstream side (replenishment fluid supply source side). A replacement fluid pump 140a and a replacement fluid clamp 140b are attached to the downstream replacement fluid line 140g in this order from the upstream side (replenishment fluid supply source side).

[0053] When a dialyzer with a low ultrafiltration rate or a stacked dialyzer that is not capable of backfiltration is used as the blood purifier 120, it is difficult to inject dialysate into the blood circuit 110 by backfiltration, so a fluid replacement line 140 is used in the priming process, fluid replacement process, and blood return process described below.

[0054] Pressure sensor 140c is used to measure the fluid pressure in fluid replacement line 140. Pressure sensor 140c is disposed, for example, in a region of upstream fluid replacement line 140f between connection port 140e and fluid replacement flow path open / close valve 140d. Pressure sensor 140c is a well-known sensor configured to continuously output the pressure in fluid replacement line 140 at short intervals, for example, several times per second. The output result from pressure sensor 140c is transmitted to and recorded by determination unit 162 of control device 160.

[0055] The replacement fluid pump 140a is a pump for sending the dialysate in the replacement fluid line 140 as a replacement fluid or priming fluid to the blood circuit 110, and is a roller pump that squeezes the circuit to send the fluid. The rotation direction, rotation speed, etc. of the replacement fluid pump 140a can be changed by the control unit 161 of the control device 160.

[0056] The replacement fluid clamp 140b is located downstream of the replacement fluid pump 140a and serves to open and close the flow path of the downstream replacement fluid line 140g. The replacement fluid clamp 140b is preferably attached near the connection of the replacement fluid line 140 with the blood circuit in order to prevent blood in the blood circuit 110 from leaking into the replacement fluid line 140. The opening and closing of the replacement fluid clamp 140b is controlled by the control unit 161 of the control device 160.

[0057] When assembling the hemodialysis device 100, one end of the downstream replacement fluid line 140g is connected to the replacement fluid line connection port 111d of the arterial line 111, and the downstream replacement fluid line 140g is attached to the replacement fluid clamp 140b near the connection point with the blood circuit 110. The other end of the downstream replacement fluid line 140g is connected to the connection port 140e, and the portion of the downstream replacement fluid line 140g upstream of the portion attached to the replacement fluid clamp 140b is attached to the replacement fluid pump 140a.

[0058] The alarm 150, under the control of the control device 160, notifies a medical professional of an abnormality if there is an abnormality in the hemodialysis device 100. For example, if the determination unit 162, which will be described in detail later, determines whether the replacement fluid line 140 is connected to the replacement fluid pump 140a in the reversed order, and determines that the replacement fluid line 140 is connected to the replacement fluid pump 140a in the reversed order, the control unit 161, which has obtained the determination result, activates the alarm 150 to sound.

[0059] The control device 160 is configured by an information processing device (computer) that operates according to a predetermined program, and includes a control unit 161 and a determination unit 162, as shown in Fig. 4. Operation buttons 163 and the like that are operated by an operator are connected to the control device 160. The operation buttons 163 include various setting buttons, such as a priming start button and a dialysis start button.

[0060] The control unit 161 operates various pumps, clamps, flow path opening / closing valves, etc. provided in the hemodialysis device 100, and controls these in each process such as the priming process and the dialysis process. In addition, the control unit 161 activates the alarm 150 when the hemodialysis device 100 is not operating normally.

[0061] The determination unit 162 determines whether the replacement fluid line 140 is connected to the replacement fluid pump 140a in reverse order based on, for example, the venous pressure measured by the venous pressure sensor 112f. The details of the determination of whether the replacement fluid line 140 is connected in reverse order will be described later.

[0062] The control device 160 controls and operates the hemodialysis device 100 by executing a control program for each process described below. The processes are a priming process, a blood removal process, a dialysis process, a fluid replacement process, a blood return process, etc.

[0063] The priming process is a preparation process in which air is removed from the blood circuit 110, blood purifier 120, dialysis circuit 130, and fluid replacement line 140, and the blood is washed and purified. The blood removal process is a process in which the blood circuit 110 is filled with the patient's blood after the blood removal needle and blood return needle are inserted. The dialysis process is a process performed following the blood removal process in which the blood is purified by dialysis while being circulated extracorporeally. The fluid replacement process is a process in which a replacement fluid is supplied to the blood circuit while simultaneously filtering an amount of water equal to the amount of the replacement fluid supplied by the blood purifier 120. This process is performed when blood pressure drops during dialysis treatment. The blood return process is a process in which the blood in the blood circuit 110 is returned to the patient's body.

[0064] The determination of whether the replacement fluid line 140 is reversed in front-to-back connection to the replacement fluid pump 140a can be made after the step of filling the venous line 112 with the priming solution, and may be made, for example, after the step of filling the blood circuit 110 with the priming solution, before a leak check of the blood circuit 110, or after the step of filling the venous line 112 and the replacement fluid line 140 with the priming solution. Preferably, from the viewpoint of improving the accuracy of the determination, the determination is made after the blood circuit 110 and the replacement fluid line 140 are filled with the dialysate as the priming solution, more preferably after a leak check of the blood circuit 110 filled with the dialysate as the priming solution is performed to confirm that there are no poor connections at the connection sites between the blood circuit 110 and the blood purifier 121, and after the step of filling the replacement fluid line 140 with the priming solution has been completed.

[0065] Next, one embodiment of the detection method of the present invention will be described with reference to FIGS. 1 to 12. FIG. 6 is a flow chart showing the priming process of the hemodialysis apparatus 100. In step S10 (see FIG. 6), immediately before priming, a medical professional assembles the hemodialysis apparatus 100. Specifically, the blood circuit 110 and the dialysate circuit 130 are connected to the blood purifier 120, and the arterial connector 111a and the venous connector 112a are connected. One end of the downstream fluid replacement line 140g is connected to the fluid replacement line connection port 111d of the arterial line 111, and the other end is connected to the connection port 140e and attached to the replacement fluid pump 140a. There are no particular limitations on the connection between the downstream fluid replacement line 140g and the fluid replacement line connection port 111d; a conventionally known connection may be used. The downstream fluid replacement line 140g may be previously integrated with the blood circuit 110. In addition, the various circuits are attached to the various air bubble detectors and clamps provided in the hemodialysis apparatus main body C. The various clamps are in an open state. The ventilation line 112e connected to the venous chamber 112b is attached to the venous pressure sensor 112f.

[0066] 6, a medical professional operates a priming start button to start the priming process, for example, automatically. When the priming start button is pressed, priming is started with the flow rates of the various pumps, the priming amount, the open / close states of the various flow path opening / closing valves (solenoid valves), and the open / close states of the various clamps, which are preset by the internal setting function of the control unit 161.

[0067] In step S30, the blood circuit 110 is filled with the priming solution by injecting the dialysis solution as the priming solution into the blood circuit 110, while removing air from the blood circuit 110. Depending on the ease of backfiltration in the blood purifier 120, either a method of injecting the dialysis solution via the blood purifier 120 or a method of injecting the dialysis solution into the blood circuit 110 via the replacement fluid line 140 is adopted as the method of injecting the priming solution into the blood circuit 110.

[0068] 1 to 3 show a method for injecting dialysate into the blood circuit 110 via the blood purifier 120. First, as shown in FIG. 1, the dialysate is sent as a priming solution to the venous line 112 via the blood purifier 120 by the dialysate sending unit 133. Specifically, the replacement fluid clamp 140b, the air bubble detector clamp 112d, and the replacement fluid flow path opening / closing valve 140d are closed to block the respective flow paths, and the other flow path opening / closing valves and other clamps are open. The dialysate introduction pump 1332, the dialysate discharge pump 1333, and the water removal / backfiltration pump 135 are operated. Next, as shown in FIG. 2, the dialysate is sent as a priming solution to the arterial line 111 via the blood purifier 120. Specifically, the replacement fluid clamp 140b and replacement fluid flow path opening / closing valve 140d are closed to block the respective flow paths, and the air bubble detector clamp 112d is changed from closed to open, and the blood pump 111b is rotated in the reverse direction to that during dialysis while the dialysate introduction pump 1332, the dialysate discharge pump 1333, and the water removal / backfiltration pump 135 are operated. Also, as shown in Figure 3, the replacement fluid flow path opening / closing valve 140d is opened, and the replacement fluid pump 140a is rotated to send dialysate as a priming fluid to the replacement fluid line 140.

[0069] In Fig. 1, for example, the dialysate introduction pump 1332 and the dialysate discharge pump 1333 send fluid at rates of 400 ml / min, the ultrafiltration / backfiltration pump 135 sends fluid at rates of 400 ml / min in the backfiltration direction, and the blood pump 111b sends fluid at rates of 0 ml / min. In Fig. 2, for example, the dialysate introduction pump 1332 and the dialysate discharge pump 1333 send fluid at rates of 400 ml / min, the ultrafiltration / backfiltration pump 135 sends fluid at rates of 400 ml / min in the backfiltration direction, and the blood pump 111b sends fluid at rates of 400 ml / min. In this way, the blood circuit 110, the dialysis circuit 130, and the blood purifier 120 are cleaned while removing air from them, and the blood circuit 110, the dialysis circuit 130, and the blood purifier 120 are filled with priming solution.

[0070] In the process of filling the replacement fluid line with priming fluid shown in FIG. 3, for example, the fluid delivery rate of the dialysis fluid discharge pump 1333 is set to 500 ml / min, the fluid delivery rate of the water removal / backfiltration pump 135 is set to 400 ml / min in the backfiltration direction, and the fluid delivery rates of the replacement fluid pump 140a and the blood pump 111b are set to 400 ml / min (step S30).

[0071] After filling the blood circuit 110 and the blood purifier 120 with the priming solution in this manner, a leak check (connection status detection) of the blood circuit 110 is performed in step S40. In the leak check process for the blood circuit 110, for example, the drainage line 113 is blocked, the air bubble detector clamp 112d is closed, and the water removal / backfiltration pump 135 is rotated in the backfiltration direction at, for example, 50 ml / min to inject dialysate as the priming solution into the blood circuit 110 through the blood purification membrane of the blood purifier 120. If no leak is present, the air pressure in the venous chamber 112b and the ventilation line 112e increases. Then, based on the venous pressure measured by the venous pressure sensor 112f and the presence or absence of fluctuations in the venous pressure, the connection status of the blood circuit 110, for example, the presence or absence of a poor connection between the blood circuit 110 and the blood purifier 120, can be detected. The leak check method is not limited to this, and any conventionally known method can be used.

[0072] In step S50, an operation is performed to determine whether the replacement fluid line 140 is connected to the replacement fluid pump 140a in a reversed front-to-back direction, based on the venous pressure measured by the venous pressure sensor 112f.

[0073] After step S50, the clamps and flow path opening / closing valves are opened to release the pressure in each circuit, and the priming process is completed.

[0074] Next, a detection method according to one aspect of the present invention will be described in detail with reference to the flowcharts of FIGS. 7 and 8 and FIGS.

[0075] After the detection of the connection state of the blood circuit during the priming step (step S40) shown in Fig. 6 , in step S51 shown in Fig. 7 and Fig. 8 , the controller 161 performs an opening / closing operation so that the priming clamp 113a is in a closed state, thereby blocking the flow path of the overflow line (drainage line) 113, as shown in Fig. 9. Preferably, from the viewpoint of improving the accuracy of the determination, the controller 161 performs an opening / closing operation so that the air bubble detector clamp 112d, the dialysate introduction flow path opening / closing valve 133a, and the dialysate introduction flow path opening / closing valve 133b are all in a closed state, thereby blocking the flow paths to which they are attached.

[0076] Next, in step S52, the replacement fluid pump 140a is rotated, for example, forward (see FIG. 9 ) or reverse (see FIG. 10 ). When the downstream replacement fluid line 140g is connected to the replacement fluid pump 140a in a chronological order, as shown in FIG. 9 , when the replacement fluid pump 140a is rotated forward, an amount of fluid corresponding to the rotation speed (number of revolutions) of the replacement fluid pump 140a is forced from the replacement fluid line 140 to the blood circuit 110, thereby increasing the venous pressure measured by the venous pressure sensor 112f. As shown in FIG. 10 , when the replacement fluid pump 140a is rotated reversely, an amount of fluid corresponding to the rotation speed (number of revolutions) of the replacement fluid pump 140a is drawn from the blood circuit 110 to the replacement fluid line 140, thereby decreasing the venous pressure measured by the venous pressure sensor 112f.

[0077] 11 and 12, when the downstream replacement fluid line 140g is attached to the replacement fluid pump 140a in reverse, as shown in Fig. 11, when the replacement fluid pump 140a is rotated forward, an amount of fluid corresponding to the number of rotations (number of times) of the replacement fluid pump 140a is drawn from the blood circuit 110 into the replacement fluid line 140, and the venous pressure measured by the venous pressure sensor 112f decreases. As shown in Fig. 12, when the replacement fluid pump 140a is rotated backward, an amount of fluid corresponding to the number of rotations (number of times) of the replacement fluid pump 140a is pushed from the replacement fluid line 140 into the blood circuit 110, and the venous pressure measured by the venous pressure sensor 112f increases.

[0078] The rotational speed (number of revolutions) of the replacement fluid pump 140a used for the determination is, for example, a maximum of 1.5 revolutions in the above embodiment, but is not limited to this in the present invention. The maximum rotational speed (number of revolutions) of the replacement fluid pump 140a used for the determination may be set to a level at which the movement of the liquid within the closed circuit due to the rotation of the replacement fluid pump 140a can be accurately detected as a fluctuation in venous pressure, taking into consideration the load on various connecting parts, the radial expansion and contraction of the tubes constituting each circuit, etc. In one embodiment, the hemodialysis apparatus of the present invention may have a bypass circuit (not shown) that bypasses a portion of the dialysate inlet line 132a upstream of the dialysate inlet flow path on-off valve 133a and a portion of the dialysate outlet line 132b downstream of the dialysate outlet flow path on-off valve 133b. In this case, an electromagnetic valve (not shown) provided in the bypass circuit may be opened to discharge excess dialysate therefrom.

[0079] Next, in step S53 (FIG. 7), it is determined whether the reverse front-rear attachment is present or not based on the fluctuation in the venous pressure caused by the forward rotation of the replacement fluid pump 140a in step S52.

[0080] Specifically, in order to determine whether the replacement fluid pump 140a is reversed, the replacement fluid pump 140a is rotated forward, and the venous pressure P ｙ From the above, the venous pressure P before the rotation of the replacement fluid pump 140a for determining whether or not the pump is reversed forward and backward is ０ The difference (P ｙ -P ０) is equal to or greater than a threshold value A preset in the determining unit 162, the determining unit 162 determines that the replacement fluid line 140 is anteroposteriorly ordered to the replacement fluid pump 140a (step S54). After determining that the replacement fluid line 140 is anteroposteriorly ordered, the determining unit 162 stops the replacement fluid pump 140a. The number of rotations Y (times) of the replacement fluid pump 140a is not particularly limited, but is preferably 0.1 to 0.7 rotations, and more preferably 0.1 to 0.5 rotations.

[0081] On the other hand, for example, the venous pressure P ｘ to the venous pressure P before the replacement fluid pump rotates ０ The difference (P ｘ -P ０ If the difference (X) is less than the threshold value A, the determination unit 162 determines that the replacement fluid line 140 is connected to the replacement fluid pump 140a in reverse. The replacement fluid pump 140a stops after determining that the replacement fluid line 140 is connected in reverse. Upon receiving the determination result that the replacement fluid pump 140a is connected in reverse, the control unit 161 activates the alarm 150 to notify the medical staff of the poor connection (step S55). The number of rotations X (times) of the replacement fluid pump 140a is preferably one rotation or less and is greater than Y.

[0082] 8, step S53 may determine whether the reverse front / rear attachment is present based on the fluctuation in venous pressure caused by the reverse rotation of the replacement fluid pump 140a in step S52. Note that in FIG. 8, steps S51 and S52 are the same as those described with reference to FIG. 7, and therefore, description thereof will be omitted.

[0083] Specifically, in order to determine whether the replacement fluid pump 140a is reversely rotated, the venous pressure P ｙ From the above, the venous pressure P before the rotation of the replacement fluid pump 140a for determining whether or not the pump is reversed forward and backward is ０ The difference (P ｙ -P ０) is equal to or less than a threshold value B preset in the determining unit 162, the determining unit 162 determines that the replacement fluid line 140 is anteroposteriorly ordered to the replacement fluid pump 140a (step S54). After determining that the replacement fluid line 140 is anteroposteriorly ordered, the determining unit 162 stops the replacement fluid pump 140a. The number of rotations Y (times) of the replacement fluid pump 140a is not particularly limited, but is preferably 0.1 to 0.7 rotations, and more preferably 0.1 to 0.5 rotations.

[0084] On the other hand, for example, the venous pressure P ｘ to the venous pressure P before the replacement fluid pump rotates ０ The difference (P ｘ -P ０ ) is greater than threshold B, the determination unit 162 determines that the replacement fluid line 140 is connected to the replacement fluid pump 140a in the reversed order. The replacement fluid pump 140a stops after determining that the replacement fluid line 140 is connected in the reversed order. Upon receiving the determination result that the replacement fluid pump 140a is connected in the reversed order, the control unit 161 activates the alarm 150 to notify the medical staff of the poor connection (step S55). The number of rotations X (times) of the replacement fluid pump 140a is preferably one rotation or less and is greater than Y.

[0085] In this way, by setting the threshold value A or B in advance and using it as a judgment element (criterion), the venous pressure P ０ This reduces erroneous determinations compared to when the determination element is the presence or absence of an increase or decrease in venous pressure from the catheter, and allows for accurate detection of improper attachment.

[0086] In order to determine whether the back and forth is reversed, the venous pressure P before the replacement fluid pump is rotated is ０ Examples of the venous pressure include the venous pressure immediately before the rotation of the replacement fluid pump 140a in step S52, or the venous pressure obtained in the leak check process for the blood circuit 110 (step S40 in FIG. 6). ０ is, for example, 10 mmHg.

[0087] The thresholds A and B can be determined, for example, as follows and set in advance in the hemodialysis device. When the rotation of the replacement fluid pump 140a for determining whether the replacement fluid line 140 is reversed is forward rotation, the threshold A is the venous pressure P when the replacement fluid pump 140a is rotated X times (for example, one rotation) with the replacement fluid line 140 connected to the replacement fluid pump 140a in the forward direction. ｘ From the above, the venous pressure P before the rotation of the replacement fluid pump for the determination ０ (e.g., 10 mmHg) minus the difference (P ｘ -P ０ ) is set to a value smaller than the venous pressure P ｘ is, for example, 510 mmHg, and the difference (P ｘ -P ０ ) is 500 mmHg.

[0088] The threshold value A may be determined taking into consideration the sensitivity of the venous pressure sensor 112f, but is preferably a value within a range of, for example, 25 mmHg or more and a value equivalent to 20% of the difference in the case of forward rotation. ｘ -P ０ ) is, for example, 500 mmHg, the threshold A is preferably a value within the range of 25 to 100 mmHg, and 40 to 60 mmHg (the difference (P ｘ -P ０ It is more preferable that the value is in the range of 8 to 12% of the difference between the above-mentioned values), and for example, 50 mmHg (corresponding to 10% of the difference) is even more preferable.

[0089] On the other hand, when the rotation of the replacement fluid pump 140a for determining whether the replacement fluid line 140 is reversed is reverse rotation, the threshold value B is the venous pressure P when the replacement fluid pump 140a is rotated X times (for example, one rotation) in a state where the replacement fluid line 140 is connected to the replacement fluid pump 140a in the forward and backward directions. ｘ From the above, the venous pressure P before the rotation of the replacement fluid pump for the determination ０ (e.g., 10 mmHg) minus the difference (P ｘ -P ０ ) is set to a value greater than the venous pressure P ｘ is, for example, −240 mmHg, and the difference (P ｘ -P ０ ) is -250 mmHg.

[0090] The threshold value B may be determined taking into consideration the sensitivity of the venous pressure sensor 112f, but is preferably a value within a range of, for example, -13 mmHg or less and a value equivalent to 20% of the difference in the case of reverse rotation. ｘ -P ０ ) is, for example, -250 mmHg, the threshold value B is preferably a value within the range of -50 to -13 mmHg, and -30 to -20 mmHg (the difference (P ｘ -P ０ A value in the range of -25 mmHg (corresponding to 8 to 12% of the difference) is more preferable, and for example, -25 mmHg (corresponding to 10% of the difference) is even more preferable.

[0091] Next, a more detailed description will be given of an example in which the threshold value A for the forward rotation of the replacement fluid pump 140a for determining whether the front and rear are reversely attached is 50 mmHg and the threshold value B for the reverse rotation is -25 mmHg. ０ is 10 mmHg.

[0092] In order to determine whether the replacement fluid line is connected in reverse, as shown in FIG. 9, when the replacement fluid pump 140a is rotated forward, if the replacement fluid line is connected to the replacement fluid pump in the forward direction, the venous pressure (P y ) reaches, for example, 60 mmHg, and the difference (P y -P ０ ) (50 mmHg) becomes equal to or greater than the threshold A (50 mmHg), and it is determined that the replacement fluid pump 140a is in the front-to-back order. After that, the replacement fluid pump 140a is immediately stopped.

[0093] On the other hand, as shown in FIG. 11, when the replacement fluid line is connected to the replacement fluid pump in reverse order, the venous pressure (P Ｘ ) is −260 mmHg, and the difference (P Ｘ -P ０ ) (-270 mmHg) is smaller than threshold A (50 mmHg), it is determined that the pump is installed backwards. Then, the replacement fluid pump 140a is immediately stopped.

[0094] In order to determine whether the replacement fluid line is connected in reverse, as shown in FIG. 10, when the replacement fluid pump 140a is rotated in the reverse direction, if the replacement fluid line is connected to the replacement fluid pump in the forward and backward directions, the venous pressure (P y ) is -15 mmHg, and the difference (P y -P ０ ) (-25 mmHg) becomes equal to or less than the threshold B (-25 mmHg), and it is determined that the replacement fluid is ordered in the front-to-back order. After that, the replacement fluid pump 140a is immediately stopped.

[0095] On the other hand, as shown in FIG. 12, when the replacement fluid line is connected to the replacement fluid pump in reverse order, the venous pressure (P Ｘ ) is 510 mmHg, and the difference (P Ｘ -P ０ ) (500 mmHg) is greater than threshold B (-25 mmHg), it is determined that the front and back are reversed.

[0096] In addition, when the operator is informed by the alarm 150 that the determination that the fluid line is reversed has been made, he or she reattaches the replacement fluid line 140 to the replacement fluid pump 140a and then presses, for example, the priming start button, thereby restarting the process from the beginning of step S50. That is, in one aspect of the hemodialysis apparatus and the detection method of the present invention, after the determination that the fluid line is reversed, preferably, the determination unit is caused to determine again whether the fluid line is reversed.

[0097] According to the hemodialysis apparatus 100 and the detection method of one aspect of the present invention described above, whether the replacement fluid line 140 is connected to the replacement fluid pump 140a in a reversed direction can be automatically determined during the priming process. This prevents excessive water removal due to an inability to supply replacement fluid caused by a reversed connection.

[0098] A preferred embodiment of the hemodialysis apparatus and detection method of the present invention has been described above, but the present invention is not limited to the above embodiment and can be modified as appropriate, for example, as described below.

[0099] In the above embodiment, the replacement fluid pump 140a is rotated (step S52) to determine whether the reversed front-to-rear connection is present, with the air bubble detector clamp 112d in a closed state and the venous line downstream of the venous chamber blocked. However, since the priming clamp 113a attached to the drainage line 113 is closed and the flow path downstream of the venous chamber is blocked, the air bubble detector clamp 112d may be in either a closed or open state in step S52. The state in which the venous line downstream of the venous chamber is blocked by, for example, the air bubble detector clamp 112d is preferable to the open state because it provides better responsiveness to changes in venous pressure when the replacement fluid pump 140a is rotated in step S52.

[0100] In the above embodiment, step S52 is performed with the dialysate introduction flow path on-off valve 133a in a closed state, blocking the flow path of the dialysate introduction line 132a. However, the dialysate introduction flow path on-off valve 133a may be in either a closed state or an open state. Blocking the flow path of the dialysate introduction line 132a, for example, with the dialysate introduction flow path on-off valve 133a is preferable compared to an open state, because it provides better response to changes in venous pressure when the replacement fluid pump 140a is rotated in step S52.

[0101] In the above embodiment, the rotation direction of the replenishment liquid pump 140a is forward rotation to determine whether the front and rear are reversely mounted, and the difference (P ｙ -P ０ ) is less than the threshold value A, the replenisher pump 140a is further rotated forward to increase the difference (P ｘ -P ０ ) is less than the threshold A, it is determined that the front and rear are reversed. ｙ In one aspect of the present disclosure, for the determination, the replacement fluid pump is rotated forward, and the venous pressure P ｙ From the above, the venous pressure P before the rotation of the replacement fluid pump ０ The difference (P ｙ -P ０) becomes equal to or greater than a threshold value A preset in the judgment unit, the judgment unit judges that the replacement fluid line is attached to the replacement fluid pump in the forward and backward order, and if the venous pressure during Y rotation of the replacement fluid pump is a negative value, the judgment unit judges that the replacement fluid line is attached to the replacement fluid pump in the reverse order.

[0102] In addition, in order to determine whether the rotation direction of the replenishment liquid pump 140a is reversed, ｙ -P ０ ) exceeds the threshold B, the replenishment liquid pump 140a is further rotated in the reverse direction to increase the (P ｘ -P ０ ) exceeds the threshold B, it is determined that the front and rear are reversed. ｙ In one aspect of the present disclosure, the replacement fluid pump is rotated in reverse for the determination, and the venous pressure P ｙ From the above, the venous pressure P before the rotation of the replacement fluid pump ０ The difference (P ｙ -P ０ ) becomes equal to or less than a threshold value B preset in the judgment unit, the judgment unit judges that the replacement fluid line is attached to the replacement fluid pump in the forward and backward order, and if the venous pressure during Y rotation of the replacement fluid pump is a positive value, the judgment unit judges that the replacement fluid line is attached to the replacement fluid pump in the reverse order.

[0103] 100 Hemodialysis device 110 Blood circuit 111b Blood pump 113 Overflow line (drainage line) 113a Priming clamp 112b Venous chamber 112d Air bubble detector clamp 112e Vent line 112f Venous pressure sensor 120 Blood purifier 130 Dialysis fluid circuit 133 Dialysis fluid delivery unit 133a Dialysis fluid introduction flow path opening / closing valve 133b Dialysis fluid extraction flow path opening / closing valve 135 Water removal / backfiltration pump 134 Bypass line 140 Replacement fluid line 140a Substitution fluid pump 140b Substitution fluid clamp 140c Pressure sensor 140d Replacement fluid flow path opening / closing valve 150 Alarm 161 Control unit 162 Determination unit C Console (device main body)

Claims

a control device including: a blood purifier having an internal blood purification membrane; a dialysate circuit; a blood circuit including an arterial line and a venous line including a venous chamber; a venous pressure sensor for measuring the pressure of gas in the venous chamber as venous pressure; a replacement fluid line for supplying the dialysate from the dialysate circuit to the blood circuit as a replacement fluid; a replacement fluid pump to which the replacement fluid line is attached; a control unit for controlling the operation of the replacement fluid pump; and a determination unit for determining whether the replacement fluid line is reversed front to back to the replacement fluid pump, wherein the replacement fluid line is opened to the dialysate circuit, the replacement fluid line is opened to the blood circuit, the replacement fluid line is opened to the blood circuit, and a flow path downstream of the replacement fluid pump is opened to the blood circuit, and any part of the flow path downstream of the venous chamber is blocked, and the determination unit determines whether the replacement fluid line is reversed front to back based on the fluctuation in the venous pressure caused by rotating the replacement fluid pump.

2. The hemodialysis device as described in claim 1, wherein the location of the flow path downstream of the venous chamber is either a portion of the venous side line downstream of the venous chamber or a drainage line connected to the venous side line.

3. For the above judgment, the replacement fluid pump is rotated in the forward direction, and the venous pressure P ｙ From the above, the venous pressure P before the rotation of the replacement fluid pump ０ When the difference between the above and the threshold value A preset in the determination unit is equal to or larger than the threshold value A, the determination unit determines that the replacement fluid line is connected to the replacement fluid pump in a front-to-back order, and determines that the venous pressure P ｘ From the above, the venous pressure P before the rotation of the replacement fluid pump ０ 3. The hemodialysis apparatus according to claim 1, wherein the determination unit determines that the replacement fluid line is connected to the replacement fluid pump in a reversed front-rear direction when the difference obtained by subtracting Y from X is less than the threshold value A. However, the relationship between the Y and the X satisfies Y<X.

4. For the above judgment, the replacement fluid pump is rotated in reverse, and the venous pressure P ｙ From the above, the venous pressure P before the rotation of the replacement fluid pump ０ When the difference obtained by subtracting the above becomes equal to or less than a threshold value B preset in the determination unit, the determination unit determines that the replacement fluid line is connected to the replacement fluid pump in a front-to-back order, and determines that the venous pressure P ｘ From the above, the venous pressure P before the rotation of the replacement fluid pump ０ 3. The hemodialysis apparatus according to claim 1, wherein the determination unit determines that the replacement fluid line is connected to the replacement fluid pump in a reversed front-rear direction when the difference obtained by subtracting Y from X is greater than the threshold value B. However, the relationship between Y and X satisfies Y<X.

5. The threshold value A is the venous pressure P at the time of X rotation when the replacement fluid pump is rotated forward in a state where the replacement fluid line is connected to the replacement fluid pump in a front-back order. ｘ From the above, the venous pressure P before the rotation of the replacement fluid pump for the determination ０ The hemodialysis apparatus according to claim 3, wherein the value is set to a value smaller than the difference between the values ​​obtained by subtracting 6. The threshold value B is the venous pressure P at the time of X rotation when the replacement fluid pump is rotated in reverse with the replacement fluid line connected to the replacement fluid pump in the forward and backward order. ｘ From the above, the venous pressure P before the rotation of the replacement fluid pump for the determination ０ The hemodialysis apparatus according to claim 4, wherein the dc voltage is set to a value greater than the difference between the dc voltage and the dc voltage minus the dc voltage.

7. A hemodialysis device as described in any one of claims 1 to 6, wherein the determination of whether or not the front and rear are reversed is performed after the dialysis fluid as a priming fluid has been filled into the blood circuit and the replacement fluid line.

8. A method for detecting reverse front-to-rear connection of a replacement fluid line of a hemodialysis apparatus, comprising: a blood purifier having a blood purification membrane therein; a dialysate circuit; a blood circuit including an arterial line and a venous line including a venous chamber; a venous pressure sensor for measuring the pressure of gas in the venous chamber as venous pressure; a replacement fluid line for supplying the dialysate from the dialysate circuit to the blood circuit as a replacement fluid; a replacement fluid pump to which the replacement fluid line is attached; a control unit for controlling the operation of the replacement fluid pump; and a determination unit for determining whether the replacement fluid line is reversed front-to-rear connection to the replacement fluid pump, the method comprising: rotating the replacement fluid pump to cause the determination unit to determine whether the replacement fluid line is reversed front-to-rear connection based on a change in the venous pressure caused by rotating the replacement fluid pump in a state in which a flow path of the replacement fluid line upstream of a portion attached to the replacement fluid pump is opened to the dialysate circuit, a flow path of the replacement fluid line downstream of a portion attached to the replacement fluid pump is opened to the blood circuit, and any portion of the flow path downstream of the venous chamber is blocked.

9. A method for detecting reverse front-to-reverse connection of a fluid replacement line of a hemodialysis apparatus as described in claim 8, wherein any point in the flow path downstream of the venous chamber is any point in the portion of the venous side line downstream of the venous chamber, or in a drainage line connected to the venous side line.

10. For the above judgment, the replacement fluid pump is rotated in the forward direction, and the venous pressure P ｙ From the above, the venous pressure P before the rotation of the replacement fluid pump ０ When the difference between the above and the threshold value A preset in the determination unit is equal to or larger than the threshold value A, the determination unit determines that the replacement fluid line is connected to the replacement fluid pump in a front-to-back order, and determines that the venous pressure P ｘ From the above, the venous pressure P before the rotation of the replacement fluid pump ０ 10. The method for detecting reversed front-rear connection of a replacement fluid line of a hemodialysis apparatus according to claim 8, wherein the determination unit determines that the replacement fluid line is connected to the replacement fluid pump in a reversed front-rear direction when the difference obtained by subtracting Y from X is less than the threshold value A. However, the relationship between Y and X is satisfied.

11. For the above judgment, the replacement fluid pump is rotated in reverse, and the venous pressure P ｙ From the above, the venous pressure P before the rotation of the replacement fluid pump ０ When the difference obtained by subtracting the above becomes equal to or less than a threshold value B preset in the determination unit, the determination unit determines that the replacement fluid line is connected to the replacement fluid pump in a front-to-back order, and determines that the venous pressure P ｘ From the above, the venous pressure P before the rotation of the replacement fluid pump ０ 10. The method for detecting reversed front-rear connection of a replacement fluid line of a hemodialysis apparatus according to claim 8, wherein the determination unit determines that the replacement fluid line is connected to the replacement fluid pump in a reversed front-rear direction when the difference obtained by subtracting Y from X is greater than the threshold value B. However, the relationship between Y and X is satisfied.

12. The threshold value A is the venous pressure P at the time of X rotation when the replacement fluid pump is rotated forward in a state where the replacement fluid line is connected to the replacement fluid pump in a front-back order. ｘ From the above, the venous pressure P before the rotation of the replacement fluid pump for the determination ０ The method for detecting front-back reversal of a replacement fluid line of a hemodialysis apparatus according to claim 10, wherein the value is set to a value smaller than the difference between the front-back reversal and the back-back reversal.

13. The threshold value B is the venous pressure P at the time of X rotation when the replacement fluid pump is rotated in reverse with the replacement fluid line connected to the replacement fluid pump in a forward and backward order. ｘ From the above, the venous pressure P before the rotation of the replacement fluid pump for the determination ０ The method for detecting front-back reversal of a replacement fluid line of a hemodialysis apparatus according to claim 11, wherein the value is set to a value greater than the difference between the front-back reversal and the back-back reversal.

14. A method for detecting front-to-reverse connection of a fluid replacement line of a hemodialysis device as described in any one of claims 8 to 13, wherein the determination of whether or not the front-to-reverse connection is present is performed after the dialysis fluid as a priming fluid has been filled into the blood circuit and the fluid replacement line.

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