Hemodialysis device

Abstract

The present disclosure provides: a hemodialysis device capable of detecting the presence or absence of a failure to mount a replacement liquid line to a replenishment liquid clamp; and a detection method thereof. In one aspect, this hemodialysis device includes a venous pressure sensor (112f) for measuring the pressure of a gas in a vein chamber (112b) as a venous pressure. After a blood circuit (110) and a replenishment fluid line (140) are filled with a priming solution, a replenishment fluid clamp (140b) is in a closed state, and a flow path on the downstream side of the vein chamber (112b) is closed. In this state, a replenishment fluid pump (140a) is rotated. On the basis of the variation in venous pressure due to this rotation, a determination unit (162) determines the presence or absence of a failure to mount the replenishment fluid line (140) to the replenishment fluid clamp (140b).

Description

hemodialysis machine

[0001] The present invention relates to a hemodialysis machine including a fluid replacement line, and a method for detecting the installation state of the fluid replacement line.

[0002] A hemodialysis machine includes a blood purifier, a blood circuit, a dialysate circuit, and a hemodialysis machine main body (also called a console). Recently, hemodialysis machines are sometimes equipped with fluid replacement lines for injecting replacement fluid into the blood circuit in order to perform online hemodiafiltration therapy, rapid fluid replacement, and other procedures. One end of the fluid replacement line is connected to the blood circuit. These circuits are assembled before treatment and connected or attached to the console. The fluid replacement line is connected to a connection port on the console. Prior to the start of treatment, each circuit is primed to remove air from the circuit and clean the interior of the circuit.

[0003] Patent Literature 1 discloses a test process for checking the connection of a replacement fluid line to a connection port (sampling port) of a console. Specifically, in this test process, a closed circuit is formed in a flow path including the connection port, a replacement fluid pump is driven, and a determination is made, for example, based on whether or not there is a drop in fluid pressure in the closed circuit. If there is a drop in fluid pressure in the closed circuit, it is determined that the connection of the replacement fluid line to the connection port is poor.

[0004] In the hemodialysis machine disclosed in Patent Document 1, a clamping device is provided in the replacement fluid line, which can open and close the flow path. If the clamping device is not in the open state and the flow path is blocked, driving the replacement fluid pump (forward or reverse rotation) during the test process cannot apply positive or negative pressure to the closed circuit. As a result, the fluid pressure remains the same as before the test process. Therefore, in the hemodialysis machine disclosed in Patent Document 1, a determining device determines whether or not the fluid pressure has changed due to the operation of the replacement fluid pump, thereby preventing the clamping device from forgetting to open.

[0005] Patent No. 5442483

[0006] The clamping means may be attached to the hemodialysis machine body, and medical personnel may attach a fluid replacement line to it during preparation before starting treatment. However, if the fluid replacement line is not attached to the clamping means or if the clamping means does not properly close the fluid replacement line, blood may leak from the blood circuit into the fluid replacement line during the dialysis process. The hemodialysis machine disclosed in Patent Document 1 can confirm the opening operation of the clamping means, but cannot distinguish between the clamping means being in an open state and the above-mentioned improper attachment of the fluid replacement line to the clamping means.

[0007] The present invention provides a hemodialysis machine capable of detecting improper attachment of a replacement fluid line to a replacement fluid clamp, and a method for detecting the same.

[0008] a replacement fluid clamp that opens and closes a flow path of the replacement fluid line downstream of a portion of the replacement fluid line that is attached to the replacement fluid pump; a control unit that controls opening and closing of the replacement fluid clamp and operation of the replacement fluid pump; and a determination unit that determines whether or not the replacement fluid line is improperly attached to the replacement fluid clamp, wherein the determination unit determines whether or not the replacement fluid line is improperly attached based on fluctuations in the venous pressure caused by rotating the replacement fluid pump while the flow path of the replacement fluid line upstream of a portion of the replacement fluid line that is attached to the replacement fluid pump is open to the dialysate circuit, the replacement fluid clamp is closed, and any portion of the flow path downstream of the venous chamber is blocked.

[0009] In one aspect, the present disclosure provides a method for detecting improper attachment of a replacement fluid line of a hemodialysis machine, the hemodialysis machine 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 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 replacement fluid clamp that opens and closes a flow path of the replacement fluid line downstream of a portion of the replacement fluid line that is attached to the replacement fluid pump; a control device that controls opening and closing of the replacement fluid clamp and operation of the replacement fluid pump; and a determination unit that determines whether the replacement fluid line is improperly attached to the replacement fluid clamp; The present invention relates to a method for detecting improper attachment of a replacement fluid line of a hemodialysis apparatus, in which the determination unit determines whether or not the replacement fluid line is improperly attached based on fluctuations in the venous pressure caused by rotating the replacement fluid pump while the flow path upstream of the portion of the replacement fluid line attached to the replacement fluid pump is open to the dialysate circuit, the replacement fluid clamp is closed, and any part of the flow path downstream of the venous chamber is blocked.

[0010] According to the present invention, it is possible to provide a hemodialysis machine capable of detecting whether or not a replacement fluid line is improperly attached to a replacement fluid clamp, and a detection method therefor.

[0011] FIG. 1 is a schematic diagram of a hemodialysis apparatus according to a first embodiment of the present invention. FIG. 2 is a block diagram showing the configuration of the hemodialysis apparatus according to the first embodiment of the present invention. FIG. 3 is a schematic diagram of a venous chamber constituting the hemodialysis apparatus according to the first embodiment of the present invention. FIG. 4 is a flow chart showing an example of a priming process in the hemodialysis apparatus according to the first embodiment of the present invention. FIG. 5 is a flow chart of a detection method according to the first embodiment of the present invention. FIG. 6 is an explanatory diagram showing a case where, in the detection method according to the first embodiment of the present invention, it is determined that there is no improper attachment of a replacement line to a replacement clamp when the replacement pump is rotated in the forward direction. FIG. 7 is an explanatory diagram showing a case where, in the detection method according to the first embodiment of the present invention, it is determined that there is no improper attachment of a replacement line to a replacement clamp when the replacement pump is rotated in the reverse direction. FIG. 8 is an explanatory diagram showing a case where, in the detection method according to the first embodiment of the present invention, it is determined that there is improper attachment of a replacement line to a replacement clamp when the replacement pump is rotated in the forward direction. FIG. 9 is an explanatory diagram showing a case where, in the detection method according to the first embodiment of the present invention, it is determined that there is improper attachment of a replacement line to a replacement clamp when the replacement pump is rotated in the reverse direction. Fig. 10 is a flow chart showing another example of the priming step in the hemodialysis apparatus according to embodiment 2 of the present invention. Fig. 11 is a flow chart showing the detection method according to embodiment 2 of the present invention. Fig. 12 is an explanatory diagram showing the case where the substitution solution pump is rotated forward in the detection method according to an embodiment of the present invention performed in the hemodialysis apparatus according to embodiment 2 of the present invention. Fig. 13 is an explanatory diagram showing the case where the substitution solution pump is rotated backward in the detection method according to an embodiment of the present invention performed in the hemodialysis apparatus according to embodiment 2 of the present invention.

[0012] In the hemodialysis device of the present invention or the method for detecting whether or not a replacement fluid line of a hemodialysis device of the present invention is improperly attached (hereinafter also referred to as the "detection method of the present invention"), to determine whether or not the replacement fluid line is improperly attached to the replacement fluid clamp, the replacement fluid clamp is closed, a location in the flow path downstream of the venous chamber is blocked, and the replacement fluid pump is rotated. If the replacement fluid line is properly attached to the replacement fluid clamp, there is no fluid flow between the replacement fluid line and the venous line, and the venous pressure measured by the venous pressure sensor does not fluctuate. On the other hand, if there is a malfunction, such as forgetting to attach the replacement fluid line to the replacement fluid clamp or the replacement fluid line flow path not being properly closed by the replacement fluid clamp, fluid will flow between the replacement fluid line and the venous line even when the replacement fluid clamp is closed by control from the control unit. Therefore, depending on the direction of rotation of the replacement fluid pump, positive or negative pressure is applied to the fluid in the venous line, and the venous pressure measured by the venous pressure sensor fluctuates, rising or falling, before and after rotation of the replacement fluid pump.

[0013] Because the blood circuit, fluid replacement line, etc. are mainly composed of flexible soft tubes and the venous pressure sensor measures air pressure, the venous pressure measured by the venous pressure sensor may fluctuate slightly (for example, about ±2 mmHg) due to vibrations of the hemodialysis machine, changes in ambient temperature, etc. In the present invention, "variation in venous pressure" does not include these slight fluctuations.

[0014] In the present invention, the location of the flow path downstream of the venous chamber refers to, for example, a location of the venous line downstream of the venous chamber when the hemodialysis apparatus of the present invention does not include a drain line connected to the venous line for discharging dialysate as a priming solution. When the hemodialysis apparatus of the present invention includes the drain line and a priming clamp for opening and closing the flow path of the drain line, the location of the flow path downstream of the venous chamber may be, for example, a location of the drain line. Note that, in this specification, the terms "upstream" and "downstream" refer to the direction of fluid flow during treatment using the hemodialysis apparatus of the present invention.

[0015] In the hemodialysis apparatus and the detection method of the present invention, the judgment unit can judge whether or not the replacement fluid line is improperly attached to the replacement fluid clamp based on such fluctuations in venous pressure depending on the rotation direction of the replacement fluid pump. Since the hemodialysis apparatus and the detection method of the present invention can detect improper attachment, blood leakage from the blood circuit to the replacement fluid line during the dialysis process can be prevented.

[0016] In the hemodialysis apparatus and the detection method of the present invention, from the viewpoint of determination accuracy, the determination of the presence or absence of improper attachment is preferably performed after the blood circuit and the fluid replacement line have been filled with dialysate as a priming fluid, and more preferably after a leak check has been performed on the blood circuit filled with the dialysate as a priming fluid and the fluid replacement line has been filled with the priming fluid.

[0017] In one aspect of the hemodialysis apparatus and the detection method of the present invention, the substitution fluid pump is rotated X times to determine whether or not there is a mounting error, and if the absolute value of the difference between the venous pressure P1 immediately after the substitution fluid pump has rotated X times and the venous pressure P0 before the substitution fluid pump has rotated X times is equal to or greater than a threshold value I preset in the determination unit, the determination unit determines that there is a mounting error. If the absolute value is less than the threshold value I, the determination unit determines that there is no mounting error. With this configuration, the presence or absence of a mounting error can be determined with high accuracy.

[0018] In one aspect of the hemodialysis apparatus and the detection method of the present invention, the threshold value I is set to a value smaller than the absolute value of the difference between the venous pressure p immediately after the substitution fluid pump has been rotated X rotations and the venous pressure p before the substitution fluid pump has been rotated X rotations under the same conditions as those for determining whether or not the substitution fluid pump is being attached, except that the substitution fluid clamp attached to the substitution fluid line is set in an open state. With this configuration, whether or not the substitution fluid pump is being attached can be determined with high accuracy.

[0019] In one aspect, the hemodialysis apparatus and the detection method of the present invention further include a venous line clamp disposed in the venous line downstream of the venous chamber for opening and closing a flow path of the venous line, and the substitution solution pump is rotated to determine whether or not there is a misplacement while the flow path of the venous line is blocked by the venous line clamp. By rotating the substitution solution pump to determine whether or not there is a misplacement while the flow path of the venous line is blocked by the venous line clamp, the presence or absence of a misplacement can be determined accurately.

[0020] In one aspect of the hemodialysis apparatus and detection method of the present invention, the downstream end of the fluid replacement line is detachably attached to the blood circuit at a position upstream of the venous chamber. The determination unit further determines whether the fluid replacement line is properly connected to the blood circuit. After the determination of whether there is no improper attachment is obtained, the control unit operates the replacement fluid clamp to change it from a closed state to an open state, and rotates the replacement fluid pump in this state to cause the determination unit to determine whether the connection is proper based on fluctuations in the venous pressure. With this configuration, it is possible to determine both whether the replacement fluid line is properly attached to the replacement fluid clamp and whether the replacement fluid line is properly connected to the blood circuit.

[0021] In one aspect, the hemodialysis apparatus and the detection method of the present invention comprise the steps of: rotating the replacement fluid pump by Y revolutions to determine whether the connection state is appropriate; and measuring the venous pressure P immediately after the replacement fluid pump has rotated by Y revolutions. 11 to the venous pressure P before Y rotations of the replacement fluid pump 10 If the absolute value of the difference obtained by subtracting the venous pressure P is equal to or greater than a threshold value II preset in the judgment unit, the judgment unit judges that the connection state is appropriate, and if the absolute value is less than the threshold value II, the judgment unit judges that the connection state is inappropriate. With this configuration, it is possible to accurately judge whether the connection state of the replacement fluid line to the blood circuit is appropriate. 11 Venous pressure P 10For the absolute value of the difference between the venous pressure P and the blood pressure P to be equal to or greater than threshold II, it is necessary that the replacement fluid line is properly connected to the blood circuit and that the replacement fluid pump is properly delivering the replacement fluid. 11 Venous pressure P 10 If the absolute value of the difference obtained by subtracting 1 from 2 is equal to or greater than threshold value II, it is possible to determine whether the connection state is appropriate and, at the same time, to confirm that the replacement fluid line is properly attached to the replacement fluid pump.

[0022] In one embodiment of the hemodialysis apparatus and the detection method of the present invention, the threshold value II is a value obtained by measuring the venous pressure p immediately after rotating the replacement fluid pump Y times under the same conditions as those used to determine whether the connection state is appropriate. 11 Venous pressure p before rotation 10 With this configuration, it is possible to accurately determine whether or not there is a mounting error.

[0023] In one aspect of the hemodialysis apparatus and the detection method of the present invention, the hemodialysis apparatus includes an alarm, and the controller activates the alarm when the determination of improper attachment indicates that there is improper attachment or when the determination of the appropriateness of the connection indicates that the connection is inappropriate. This configuration reduces the burden of attention on an operator preparing for dialysis treatment.

[0024] 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.

[0025] (Embodiment 1) Fig. 1 is a diagram showing a schematic configuration of one embodiment of the hemodialysis apparatus of the present invention, and Fig. 2 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.

[0026] 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.

[0027] 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.

[0028] 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.

[0029] 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.

[0030] The arterial line 111 has one end connected to the blood inlet 122a of the blood purifier 120, and the other end including 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).

[0031] 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. 2 ) 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).

[0032] 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.

[0033] 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).

[0034] 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.

[0035] 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 accordance with 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 no air bubbles are detected. Examples of times other than when air bubbles are detected include when the replacement fluid pump 140a is rotating to determine whether the replacement fluid line 140 is improperly attached to the replacement fluid clamp 140b, as described below, and when the replacement fluid pump 140a is rotating to determine whether the replacement fluid line 140 is properly connected to the blood circuit 110.

[0036] As shown in Fig. 3 , venous chamber 112b includes chamber main body 1120b for containing liquid, inlet 1121b connected to a portion of venous line 112 upstream of venous chamber 112b for introducing liquid into chamber main body 1120b, vent 1122b for gas inflow and outflow, outlet 1123b for discharging liquid from venous chamber 112b to overflow line 113, and outlet 1124b formed at the bottom of chamber main body 1120b for discharging liquid from 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 Fig. 1 ) is attached to the other end of ventilation line 112e, for example, to measure the pressure of gas in venous chamber 112b and ventilation line 112e as venous pressure.

[0037] 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.

[0038] 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).

[0039] 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.

[0040] 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.

[0041] 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.

[0042] 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.

[0043] 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.

[0044] 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.

[0045] 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.

[0046] 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.

[0047] 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.

[0048] 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.

[0049] 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 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.

[0050] 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.

[0051] 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.

[0052] [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.

[0053] [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.

[0054] 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.

[0055] 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).

[0056] 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.

[0057] 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.

[0058] 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.

[0059] 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.

[0060] 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.

[0061] The alarm 150 is controlled by the control device 160 to notify a medical professional of an abnormality in the hemodialysis device 100. For example, if the determination unit 162, which will be described in detail later, determines whether or not there is an improper attachment of the replacement fluid line 140 to the replacement fluid clamp 140b and determines that there is such an improper attachment, the control unit 161, which has obtained the determination result, activates the alarm 150 to make the alarm 150 sound.

[0062] 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. 2. 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.

[0063] 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.

[0064] The determination unit 162 determines whether or not the replacement fluid line 140 is improperly attached to the replacement fluid clamp 140b based on, for example, the venous pressure measured by the venous pressure sensor 112f. The details of determining whether or not the replacement fluid line 140 is improperly attached will be described later.

[0065] 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.

[0066] 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.

[0067] The determination of whether or not there is a malfunction in the attachment of the replacement fluid line 140 to the replacement fluid clamp 140b 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 a leak check of the blood circuit 110 filled with the dialysis solution as the priming solution is performed to confirm that there is no malfunction in the connection between the blood circuit 110 and the blood purifier 121, and after the replacement fluid line 140 is filled with the priming solution.

[0068] Next, one embodiment of the detection method of the present invention will be described with reference to FIGS. 1 to 9. FIG. 4 is a flow chart showing the priming process of the hemodialysis apparatus 100. In step S10 (see FIG. 4), 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 various air bubble detectors, various flow path opening / closing valves (solenoid valves), and various clamps provided in the hemodialysis apparatus main body C. The various flow path opening / closing valves and various clamps are in an open state.

[0069] 4, 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.

[0070] 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.

[0071] 1 shows a method of injecting dialysate as a priming solution into the blood circuit 110 via the substitution solution line 140. As shown in Fig. 1, various flow path on-off valves and various clamps are opened, and the dialysate introduction pump 1332 and the dialysate discharge pump 1333 are operated, as well as the water removal / backfiltration pump 135, the substitution solution pump 140a, and the blood pump 111b. As shown in Fig. 1, the blood pump 111b is operated in the opposite direction to that during dialysis, i.e., so as to send the liquid in the arterial line 111 upstream in the direction of blood flow during dialysis.

[0072] For example, by setting the dialysate introduction pump 1332 and the dialysate discharge pump 1333 to a flow rate of 500 ml / min, the water removal / backfiltration pump 135 and the replacement fluid pump 140a to a flow rate of 400 ml / min, and the blood pump 111b to a flow rate of 360 ml / min, the dialysate as a priming fluid is directly supplied to the arterial line 111 and discharged from the overflow line 113. In this way, the blood circuit 110, the dialysis circuit 130, the replacement fluid line 140, and the blood purifier 120 are cleaned while removing air from them, and the blood circuit 110, the dialysis circuit 130, the replacement fluid line 140, and the blood purifier 120 are filled with the priming fluid (step 30).

[0073] 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 flow path of the drainage line 113 is blocked, the air bubble detector clamp 112d is closed, and the priming solution is injected into the blood circuit 110 via the blood purifier 120 or via the fluid replacement line 140. If no leak is present, the air pressure in the venous chamber 112b and the ventilation line 112e increases. Based on the venous pressure measured by the venous pressure sensor 112f, the connection status of the blood circuit 110, for example, whether or not there is 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 also be used.

[0074] Next, in step S50, it is determined whether or not the replacement fluid line 140 is improperly attached to the replacement fluid clamp 140b based on fluctuations in venous pressure caused by the rotation of the replacement fluid pump 140a. The details of this determination will be described later.

[0075] 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.

[0076] 4, in the priming step, immediately after the leak check of the blood circuit 110 (step S40), a determination is made as to whether or not the replacement fluid line 140 is improperly attached to the replacement fluid clamp 140b (step S50). However, after step S40 and before step S50, if necessary, further checks may be made on other items. Furthermore, after step S50, if necessary, further checks may be made on other items before releasing the pressure in each circuit and completing the priming step.

[0077] Next, a detection method according to one aspect of the present invention will be described in detail with reference to the flowchart of FIG. 5 and FIGS.

[0078] After the leak check (connection state detection) (step S40) of blood circuit 110 during the priming step shown in Fig. 4, in step S51 shown in Fig. 5, controller 161 opens and closes priming clamp 113a and replacement fluid clamp 140b as needed, so that they are closed, and replacement fluid flow path opening / closing valve 140d is open, as shown in Fig. 6. With priming clamp 113a closed, the flow path downstream of venous chamber 112b is blocked, and with replacement fluid flow path opening / closing valve 140d open, the flow path upstream of the part of replacement fluid line 140 attached to replacement fluid pump 140a is open to dialysate circuit 130.

[0079] Next, in step S52, the substitution fluid pump 140a is rotated forward (see FIG. 6) or backward (see FIG. 7), for example, by about 0.1 revolution. Forward rotation refers to a rotation direction that allows the supply of dialysate to the blood circuit, and backward rotation refers to a rotation direction opposite to that. If the downstream replacement fluid line 140g is not improperly attached to the substitution fluid clamp 140b, the flow path of the downstream replacement fluid line 140g is blocked by the substitution fluid clamp 140b, no fluid flows between the blood circuit 110 and the replacement fluid line 140, and the venous pressure measured by the venous pressure sensor 112f does not fluctuate.

[0080] On the other hand, if there is a mounting error, rotating the replacement fluid pump 140a forward sends the liquid in the replacement fluid line 140 to the blood circuit 110 side including the venous line 112, causing an increase in venous pressure (see FIG. 8).If rotating the replacement fluid pump 140a backward, the liquid in the blood circuit 110 is sent to the replacement fluid line 140 side, causing a decrease in venous pressure (see FIG. 9).

[0081] In the above embodiment, the rotational speed (number of revolutions) of the replacement fluid pump 140a used to determine whether or not there is a mis-attachment is 0.1 revolutions, but this is not limited to this in the present invention. The rotational speed (number of revolutions) of the replacement fluid pump 140a may be set to a value that minimizes the load on the replacement fluid line 140 and the replacement fluid clamp 140b due to positive or negative pressure, and that allows the venous pressure sensor 112f to easily detect any mis-attachment as a fluctuation in venous pressure.

[0082] Next, in step S53, the presence or absence of the above-mentioned misplacement is determined based on the fluctuation in venous pressure caused by the rotation of the replacement fluid pump 140a in step S52. Specifically, the replacement fluid pump 140a is rotated 0.1 revolutions, and if the absolute value of the difference between the venous pressure P immediately after 0.1 revolution of the replacement fluid pump 140a and the venous pressure P before that rotation is less than a threshold value I preset in the determination unit 162 (i.e., not equal to or greater than the threshold value I), the determination unit 162 determines that there is no misplacement (step S54). If the absolute value is not less than the threshold value I (i.e., not less than the threshold value I), the determination unit 162 determines that there is a misplacement. Upon receiving the determination result that there is a misplacement, the control unit 161 activates the alarm 150 to notify the medical professional (step S55), and then ends the determination. In this way, by setting a threshold value I in advance and using this as the judgment element (criterion), it is possible to reduce erroneous judgments compared to when the judgment element is simply the rise or fall from the venous pressure P0 before rotation, and to accurately detect improper attachment.

[0083] The venous pressure P may be the venous pressure immediately before the replacement fluid pump 140a starts rotating in step S52, or the venous pressure obtained in the leak check process (step S40 in FIG. 4) for the blood circuit 110. The venous pressure P is, for example, −50 to 50 mmHg.

[0084] The threshold value I can be determined, for example, as follows and is set in advance in the determination unit 162 of the hemodialysis apparatus. The threshold value I is set to a value smaller than the absolute value of the difference between the venous pressure p1 immediately after rotating the substitution fluid pump 140a X rotations (e.g., 0.1 rotations) and the venous pressure p0 before rotating the substitution fluid pump 140a X rotations (e.g., 0 mmHg) under the same conditions as those for determining whether or not the substitution fluid clamp 140b is in an open state. However, it is assumed that the venous pressures p1 and p0 used to determine the threshold value I are values ​​measured under conditions in which the downstream substitution fluid line 140g is properly attached to the substitution fluid clamp 140b. The venous pressure p1 in the case of forward rotation is, for example, 70 mmHg, and the venous pressure p1 in the case of reverse rotation is, for example, −70 mmHg. The absolute values ​​of the difference p1 − p0 are both 70 mmHg. The threshold value I can be determined taking into consideration the sensitivity of the venous pressure sensor 112f. However, it is preferable to set the threshold value I to a value smaller than the absolute value. If the venous pressure sensor 112f is a conventional pressure sensor, a value in the range of 20 mmHg or greater and 60 to 70% of the absolute value is preferable. Alternatively, because venous pressure may change slightly even when the flow path of the downstream replacement fluid line 140g is properly blocked by the replacement fluid clamp 140b, it is preferable to set the threshold value I to a value greater than the amount of change. Specifically, if the time required for X rotations is S seconds, the amount of change in pressure over S seconds is confirmed while the replacement fluid pump 140a is not rotating. If the amount of change is, for example, approximately ±Z mmHg, the threshold value I is preset to a value greater than or equal to 1.5 times the absolute value Z of the amount of change. This is preferable because it reduces the risk of false detection. More specifically, if the time required for 0.1 rotation is 1 second, the amount of change in pressure during 1 second is checked while the replacement fluid pump 140a is not rotating, and if the amount of change is, for example, approximately ±2 mmHg, the threshold value I is set to a value greater than, for example, 1.5 times the absolute value of the amount of change, for example, 6 mmHg.

[0085] According to the hemodialysis apparatus 100 and the detection method of one aspect of the present invention described above, the presence or absence of improper attachment of the downstream fluid replacement line 140g to the replacement fluid clamp 140b can be automatically determined during the priming process, thereby preventing blood leakage from the blood circuit into the fluid replacement line during the dialysis process.

[0086] (Embodiment 2) The hemodialysis apparatus of this embodiment shown in Figures 12 and 13 has the same configuration as the dialysis apparatus of Embodiment 1, except that it can determine whether the connection between the replacement fluid line 140 and the blood circuit 110 is appropriate. Therefore, the schematic configuration of the hemodialysis apparatus of this embodiment is also the same as that shown in Figure 1, and in Figures 12 and 13, the same components as those of the dialysis apparatus of Embodiment 1 are assigned the same component numbers and their description will be omitted. In addition, the block diagram of the configuration of the hemodialysis apparatus of this embodiment is also the same as that shown in Figure 2, so the block diagram of the configuration of the hemodialysis apparatus of this embodiment will be omitted. Details of the determination of whether the connection between the replacement fluid line 140 and the blood circuit 110 is appropriate will be described later.

[0087] FIG. 10 is a flow chart showing the priming process in the hemodialysis apparatus of this embodiment of the present invention, and FIG. 11 is a flowchart of the detection method of this embodiment of the present invention. The detection method of this embodiment of the present invention is identical to the detection method of embodiment 1, except that, after determining whether or not there is a malfunction in the downstream replacement fluid line 140g attached to the replacement fluid clamp 140b (step S53) and determining that there is no malfunction (step S54), the controller 161 controls the replacement fluid clamp 140b to change from a closed state to an open state, then rotates the replacement fluid pump 140a, and the determination unit 162 determines whether or not the replacement fluid line 140 and the blood circuit 110 are properly connected (steps S61 to S65). Therefore, in FIGS. 10 and 11 , steps that are identical to those in the detection method of embodiment 1 are denoted by the same reference numerals, and their description will be omitted.

[0088] 10, steps S10 to S50 are the same as those in (Embodiment 1). In the detection method of this embodiment, after step S50, in which the attachment state of the fluid replacement line 140 to the replacement fluid clamp 140b is determined, the appropriateness of the connection state between the fluid replacement line 140 and the blood circuit 110 is determined (step S60) before the clamps and flow path opening / closing valves are opened to release the pressure in each circuit.

[0089] 11 is a flowchart of the detection method of this embodiment, and steps S51 to S55 are the same as those of (Embodiment 1). In the detection method of this embodiment, if it is determined in step S53 whether or not there is a malfunction in the attachment of the fluid replacement line 140 to the replacement fluid clamp 140b that there is no malfunction, the process proceeds to step S61, in which the connection state of the fluid replacement line 140 and the blood circuit 110 is determined.

[0090] As shown in FIG. 11 , in step S61, the controller 161 changes the replacement fluid clamp 140a from a closed state to an open state. Next, as shown in FIG. 12 , the replacement fluid pump 140a is rotated forward, for example, by about 0.1 rotation. Because the replacement fluid clamp 140b is open, if the downstream replacement fluid line 140g is properly connected to the replacement fluid line connection port 111d of the arterial line 111, the fluid in the replacement fluid line 140 is sent to the blood circuit 110, thereby increasing the venous pressure. When the replacement fluid pump 140a is rotated backward, for example, by about 0.1 rotation, the fluid in the blood circuit 110 is sent to the replacement fluid line 140, as shown in FIG. 13 , thereby decreasing the venous pressure.

[0091] On the other hand, if the connection between the downstream replacement fluid line 140g and the replacement fluid line connection port 111d is improper, for example, if the replacement fluid line 140 has been forgotten to be connected to the blood circuit 110, even if the replacement fluid pump 140a is rotated forward (see FIG. 12) or backward (see FIG. 13) in step S62, no fluid flows between the replacement fluid line 140 and the blood circuit 110, and the venous pressure measured by the venous pressure sensor 112f does not fluctuate. Note that the venous pressure measured by the venous pressure sensor 112f may fluctuate slightly due to vibrations of the hemodialysis apparatus, changes in ambient temperature, and the like, regardless of whether the replacement fluid pump 140a is rotating. However, as described above, these slight fluctuations are not included in the "variation in venous pressure" in the present invention.

[0092] In the above embodiment, the number of rotations (number of times) of the replacement fluid pump 140a used to determine whether the connection is appropriate is 0.1 rotation, but this is not limited to this in the present invention. The number of rotations (number of times) of the replacement fluid pump 140a may be set to a value that allows the venous pressure sensor 112f to clearly detect a change in venous pressure when the connection is appropriate.

[0093] Next, in step S63, the appropriateness of the connection state is determined based on the fluctuation in venous pressure due to the rotation of the replacement fluid pump 140a in step S62. Specifically, the replacement fluid pump 140a is rotated, for example, by 0.1 revolution, and the venous pressure P 11 From the above, the venous pressure P before the replacement fluid pump rotation 10 If the absolute value of the difference obtained by subtracting β is equal to or greater than a threshold value II preset in the determination unit 162, the determination unit 162 determines that the connection state is appropriate (step S64), and if it is less than the threshold value II, the determination unit 162 determines that the connection state is inappropriate. The control unit 161, having obtained a determination result that the connection state is inappropriate, activates the alarm 150 to notify the medical staff (step S65), and ends the determination. In this way, by setting the threshold value II in advance and using it as a reference, it is possible to simply determine the venous pressure P before rotation. 10 This reduces erroneous determinations compared to when the determination factor is ascent or descent from the seat, and the appropriateness of the wearing state can be determined with high accuracy.

[0094] Venous pressure P 10 Examples of the venous pressure include the venous pressure immediately before the rotation of the replacement fluid pump 140a in step S52 or step S62, and the venous pressure obtained in the leak check process for the blood circuit 110 (step S40 in FIG. 10). 10 is, for example, 0 mmHg.

[0095] The threshold value II can be determined, for example, as follows and set in advance in the judgment unit 162 of the hemodialysis device. The threshold value II is determined by the venous pressure P immediately after rotating the replacement fluid pump 140a by Y rotations (for example, 0.1 rotations) under the same conditions as those for judging whether the connection state is appropriate. 11 From the above, the venous pressure P before rotating Y 10 (e.g., 0 mmHg) is set to a value smaller than the absolute value of the difference between the venous pressure P 11 and venous pressure P 10 It is assumed that the value is measured under the condition that the downstream replacement fluid line 140g and the replacement fluid line connection port 111d are properly connected. 11 is, for example, 70 mmHg, and the venous pressure P 11 is, for example, -70 mmHg, and the difference P 11 -P 10 The absolute values ​​of these values ​​are 70 mmHg. Threshold value II may be determined taking into consideration the sensitivity of venous pressure sensor 112f, but it is preferable to set it to a value smaller than these absolute values, and it is preferable to set it to a value within the range of 20 mmHg or more and equal to or less than a value equivalent to 60 to 70% of the absolute values.

[0096] In the hemodialysis apparatus of this embodiment and the detection method of one embodiment of the present invention described above, after it is determined that there is no improper attachment of the replacement fluid line to the replacement fluid clamp, it is possible to confirm that the connection between the replacement fluid line 140 and the blood circuit 110 is appropriate. 11 -P 10In order for the absolute value of 1 to be equal to or greater than threshold value II, it is necessary that replacement fluid line 140 is properly connected to replacement fluid pump 140a. Therefore, in addition to confirming that the connection state is appropriate, it is also possible to confirm that replacement fluid line 150 is properly connected to the replacement fluid pump.

[0097] 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.

[0098] In the above-described first and second embodiments, the replacement fluid pump 140a is rotated to determine whether the replacement fluid pump 140a is properly attached (step S52) and whether the replacement fluid pump 140a is properly connected (step S62) while the air bubble detector clamp 112d is closed to block the flow path of the venous line downstream of the venous chamber. However, since the priming clamp 113a attached to the flow path of the drainage line 113 is closed to block the flow path downstream of the venous chamber, the air bubble detector clamp 112d may be either closed or open in step S52 and / or step S62. The state in which the flow path of 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 steps S52 and S62 (see FIGS. 5 and 11 ).

[0099] In the above-described first and second embodiments, the dialysate introduction flow path on-off valve 133a is closed, and the dialysate introduction line 132a is blocked. The replacement fluid pump 140a is rotated to determine whether the installation is improper (step S52), and the replacement fluid pump 140a is rotated to determine whether the connection is proper (step S62). However, the dialysate introduction flow path on-off valve 133a may be either closed or open. The state in which the dialysate introduction line 132a is blocked by, for example, the dialysate introduction flow path on-off valve 133a is preferable to the state in which the dialysate introduction line 132a is open, because this state provides better responsiveness to changes in venous pressure when the replacement fluid pump 140a is rotated in steps S52 and S62.

[0100] 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 dialysate from the dialysate circuit to the blood circuit as replacement fluid, a replacement fluid pump to which the replacement fluid line is attached, a replacement fluid clamp for opening and closing a flow path of the replacement fluid line downstream of a portion of the replacement fluid line attached to the replacement fluid pump, a control unit for controlling the opening and closing of the replacement fluid clamp and the operation of the replacement fluid pump, and a determination unit for determining whether or not the replacement fluid line is improperly attached to the replacement fluid clamp, wherein the replacement fluid clamp is in a closed state, and any portion of the flow path downstream of the venous chamber is blocked, and the determination unit determines whether or not the replacement fluid line is improperly attached based on fluctuations in the venous pressure caused by rotating the replacement fluid pump when the flow path of the replacement fluid line upstream of the portion of the replacement fluid line attached to the replacement fluid pump is opened to the dialysate circuit, the replacement fluid clamp is in a closed state, and 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. The hemodialysis device according to claim 1 or 2, wherein the replacement fluid pump is rotated by X revolutions to determine the presence or absence of the attachment failure, and if an absolute value of a difference obtained by subtracting the venous pressure P0 before the replacement fluid pump has rotated by X revolutions from the venous pressure P1 immediately after the replacement fluid pump has rotated by X revolutions is equal to or greater than a threshold value I preset in the determination unit, the determination unit determines that the attachment failure exists, and if the absolute value is less than the threshold value I, the determination unit determines that the attachment failure does not exist.

4. The hemodialysis apparatus according to claim 3, wherein the threshold value I is set to a value smaller than the absolute value of the difference between the venous pressure p1 immediately after the replacement fluid pump has been rotated X revolutions and the venous pressure p0 before the replacement fluid pump has been rotated X revolutions under the same conditions as those for determining whether or not the replacement fluid clamp attached to the replacement fluid line is open.

5. A hemodialysis device as described in any one of claims 1 to 4, wherein the downstream end of the replacement fluid line is attachable to and detachable from the blood circuit upstream of the venous chamber of the blood circuit, and the judgment unit is further capable of judging the connection status of the replacement fluid line to the blood circuit, and after a judgment result indicating that there is no improper attachment is obtained, the control unit operates the replacement fluid clamp to an open state, and causes the judgment unit to judge the suitability of the connection status based on fluctuations in the venous pressure caused by rotating the replacement fluid pump.

6. To determine whether the connection is appropriate, the replacement fluid pump is rotated Y times, and the venous pressure P immediately after the replacement fluid pump is rotated Y times is measured. 11 to the venous pressure P before Y rotations of the replacement fluid pump 10 6. The hemodialysis apparatus according to claim 5, wherein, when an absolute value of the difference obtained by subtracting 7. The threshold value II is the venous pressure p immediately after the replacement fluid pump is rotated Y revolutions under the same conditions as those for judging whether the replacement fluid line and the blood circuit are connected and the connection state is judged to be appropriate. 11 From the above, the venous pressure p before rotating by Y 10 The hemodialysis apparatus according to claim 6, wherein the value is set to a value smaller than the absolute value of the difference obtained by subtracting 8. A hemodialysis device as described in any one of claims 1 to 7, wherein the determination of the presence or absence of improper installation is performed after the dialysis fluid as a priming fluid has been filled into the blood circuit and the replacement fluid line.

9. A method for detecting improper attachment of a replacement fluid line of a hemodialysis device, comprising: the hemodialysis device; 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 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 replacement fluid clamp for opening and closing a flow path of the replacement fluid line downstream of a portion of the replacement fluid line that is attached to the replacement fluid pump; a control unit for controlling the opening and closing of the replacement fluid clamp and the operation of the replacement fluid pump; and a control device for determining whether or not the replacement fluid line is improperly attached to the replacement fluid clamp; A method for detecting improper installation of a replacement fluid line of a hemodialysis apparatus, comprising the steps of: opening a flow path upstream of a portion of the replacement fluid line attached to the replacement fluid pump to the dialysis fluid circuit; closing the replacement fluid clamp; and blocking any portion of the flow path downstream of the venous chamber; and causing the determination unit to determine whether or not the replacement fluid line is improperly installed based on fluctuations in the venous pressure caused by rotating the replacement fluid pump.

10. A method for detecting improper installation of a fluid replacement line of a hemodialysis apparatus as described in claim 9, 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.

11. A method for detecting improper attachment of a replacement fluid line of a hemodialysis apparatus as described in claim 9 or 10, wherein the replacement fluid pump is rotated by X revolutions to determine the presence or absence of improper attachment, and if an absolute value of a difference obtained by subtracting the venous pressure P0 before X revolutions of the replacement fluid pump from the venous pressure P1 immediately after X revolutions of the replacement fluid pump is equal to or greater than a threshold value I preset in the determination unit, the determination unit determines that there is improper attachment, and if the absolute value is less than the threshold value I, the determination unit determines that there is no improper attachment.

12. A method for detecting improper installation of a replacement fluid line of a hemodialysis apparatus as described in claim 11, wherein the threshold value I is set to a value smaller than the absolute value of the difference between the venous pressure p1 immediately after the replacement fluid pump has been rotated X rotations and the venous pressure p0 before the replacement fluid pump is rotated X rotations under the same conditions as those for determining whether or not the replacement fluid line is installed improperly, except that the replacement fluid clamp attached to the replacement fluid line is set in an open state.

13. A method for detecting improper installation of a fluid replacement line of a hemodialysis apparatus as described in any one of claims 9 to 12, wherein the downstream end of the fluid replacement line is attachable to and detachable from the blood circuit upstream of the venous chamber of the blood circuit, the judgment unit is further capable of judging the connection status of the fluid replacement line to the blood circuit, and after a judgment result indicating that there is no improper installation is obtained, the control unit operates the replacement fluid clamp to an open state, and causes the judgment unit to judge whether the connection status is appropriate based on fluctuations in the venous pressure caused by rotating the replacement fluid pump.

14. To determine whether the connection is appropriate, the replacement fluid pump is rotated Y times, and the venous pressure P immediately after the replacement fluid pump is rotated Y times is measured. 11 to the venous pressure P before Y rotations of the replacement fluid pump 10 14. The method for detecting improper installation of a replacement fluid line of a hemodialysis apparatus according to claim 13, wherein, when an absolute value of the difference obtained by subtracting 15. The threshold value II is the venous pressure p immediately after the replacement fluid pump is rotated Y revolutions under the same conditions as those for judging whether the replacement fluid line and the blood circuit are connected and the connection state is judged. 11 From the above, the venous pressure p before rotating by Y 10 The method for detecting improper installation of a fluid replacement line of a hemodialysis apparatus according to claim 14, wherein the value is set to a value smaller than the absolute value of the difference obtained by subtracting 16. A method for detecting improper installation of a fluid replacement line of a hemodialysis device as described in any one of claims 9 to 15, wherein the determination of the presence or absence of improper installation 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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