Hemodialysis device

Abstract

The invention provides a hemodialysis device and a corresponding detection method capable of detecting poor installation of a fluid infusion pipeline to a fluid infusion clamp. One embodiment of the present invention relates to a hemodialysis device (100) comprising a venous pressure sensor (112f) for detecting the gas pressure within a venous cavity (112b) as a venous pressure, and a fluid infusion clip (140b) being in a closed state after a blood circuit (110) and a fluid infusion line (140) are filled with a pre-filling fluid. When the flow path on the downstream side of the venous cavity (112b) is closed, a determination unit (162) determines whether or not there is a poor attachment of the fluid infusion line (140) to the fluid infusion clip (140b) on the basis of a change in venous pressure caused by rotation of the fluid infusion pump (140a).

Description

Technical Field

[0001] This invention relates to a hemodialysis device including a fluid replenishment tubing, and a method for detecting the installation status of the fluid replenishment tubing. Background Technology

[0002] A hemodialysis device includes a blood purifier, blood circuits, dialysate circuits, and the main body of the hemodialysis device (also called a control console). In recent years, for online hemodialysis filtration therapy and rapid fluid resuscitation, hemodialysis devices sometimes include resuscitation tubing for injecting resuscitation fluid into the blood circuits. One end of the resuscitation tubing is connected to the blood circuit. These circuits are assembled before treatment and connected or installed to the control console. The resuscitation tubing is connected to the control console via a port. Furthermore, before treatment begins, each circuit is pre-charged to remove air and purge the circuit.

[0003] Patent Document 1 discloses a test procedure for verifying the connection of a replenishment line to a control console's connection port (take-up port). Specifically, in this test procedure, a closed loop is formed in the flow path including the connection port, and a replenishment pump is driven to determine, for example, whether or not there is a drop in hydraulic pressure within the closed loop. If the hydraulic pressure within the closed loop decreases, it is determined that the replenishment line is poorly connected to the connection port.

[0004] In the hemodialysis apparatus disclosed in Patent Document 1, a clamping mechanism capable of opening and closing the flow path is provided in the rehydration tubing. When the flow path is blocked because the clamping mechanism is not in the open state, even if the rehydration pump is driven (forward or reverse) during a test step, it is impossible to apply positive or negative pressure to the closed loop. Therefore, the hydraulic pressure remains unchanged compared to its value before the test step. Thus, in the hemodialysis apparatus disclosed in Patent Document 1, by using a determination mechanism to determine whether the change in hydraulic pressure accompanying the driving of the rehydration pump exists, it is possible to simultaneously prevent forgetting to open the clamping mechanism.

[0005] Existing technical documents Patent documents Patent Document 1: Japanese Patent No. 5442483 Summary of the Invention

[0006] The technical problem that the invention aims to solve In the aforementioned clamping mechanism, there is a type that is installed on the main body of the hemodialysis device, where medical personnel install the rehydration tubing during the preparation stage before treatment begins. However, if there is a misinstallation, such as forgetting to install the rehydration tubing into the clamping mechanism or the flow path of the rehydration tubing not being properly closed by the clamping mechanism, blood may leak from the blood circuit into the rehydration tubing during the dialysis step. In the hemodialysis device disclosed in Patent Document 1, although it is possible to confirm the opening of the clamping mechanism, it is impossible to distinguish between the clamping mechanism being in the open state and the aforementioned misinstallation of the rehydration tubing into the clamping mechanism.

[0007] This invention provides a hemodialysis device and a detection method for detecting improper installation of the fluid infusion line into the fluid infusion clamp.

[0008] Means for solving technical problems In one aspect of this disclosure, a blood purification device is disclosed, comprising: a blood purifier with a built-in blood purification membrane; a dialysate circuit; a blood circuit including: an arterial side line; and a venous side line including a venous lumen; a venous pressure sensor for measuring the pressure of gas within the venous lumen as venous pressure; a rehydration line for supplying dialysate as rehydration fluid from the dialysate circuit to the blood circuit; a rehydration pump on which the rehydration line is mounted; and a rehydration clamp on the rehydration line, located downstream of the portion of the rehydration line mounted on the rehydration pump. The device includes: a control unit for opening and closing the infusion clamp and operating the infusion pump; and a determination unit for determining whether there is a faulty installation of the infusion tubing to the infusion clamp, wherein the flow path in the infusion tubing upstream of the portion installed on the infusion pump is open to the dialysate circuit, and the determination unit determines whether there is a faulty installation based on the change in venous pressure caused by rotating the infusion pump when the infusion clamp is closed and any part of the flow path downstream of the venous lumen is blocked.

[0009] One aspect of this disclosure relates to a method for detecting improper installation of the rehydration tubing in a hemodialysis device, characterized in that the hemodialysis device comprises: a blood purifier with a built-in blood purification membrane; a dialysate circuit; a blood circuit including: an arterial side tubing; and a venous side tubing including a venous lumen; a venous pressure sensor for measuring the pressure of gas within the venous lumen as venous pressure; a rehydration tubing for supplying dialysate as rehydration fluid from the dialysate circuit to the blood circuit; a rehydration pump on which the rehydration tubing is installed; and a rehydration clamp installed in the rehydration tubing relative to the rehydration pump. The device includes: a control unit for opening and closing the flow path of the rehydration tubing on the downstream side; and a control device comprising: a control unit for controlling the opening and closing of the rehydration clamp and the operation of the rehydration pump; and a determination unit for determining whether there is a faulty installation of the rehydration tubing to the rehydration clamp, wherein the flow path of the rehydration tubing on the upstream side of the rehydration pump is open to the dialysate circuit, and the determination unit determines whether there is a faulty installation based on the change in venous pressure caused by rotating the rehydration pump when the rehydration clamp is closed and any part of the flow path on the downstream side of the venous lumen is blocked.

[0010] Invention Effects According to the present invention, a hemodialysis device and a detection method thereof are provided that can detect whether there is a malfunction in the installation of the fluid infusion tubing to the fluid infusion clamp. Attached Figure Description

[0011] Figure 1 This is a schematic diagram of the hemodialysis apparatus according to Embodiment 1 of the present invention.

[0012] Figure 2 This is a block diagram showing the structure of the hemodialysis device according to Embodiment 1 of the present invention.

[0013] Figure 3 This is a schematic diagram of the venous cavity of the hemodialysis device constituting Embodiment 1 of the present invention.

[0014] Figure 4 This is a flowchart illustrating an example of the pre-filling step of the hemodialysis apparatus according to Embodiment 1 of the present invention.

[0015] Figure 5 This is a flowchart of the detection method according to Embodiment 1 of the present invention.

[0016] Figure 6 This is an explanatory diagram illustrating a situation in the detection method of Embodiment 1 of the present invention where, when the replenishment pump is rotated in the forward direction, it is determined that there is no faulty installation of the replenishment line to the replenishment clamp.

[0017] Figure 7This is an explanatory diagram illustrating a situation in the detection method of Embodiment 1 of the present invention where, when the replenishment pump is reversed, it is determined that there is no replenishment line to the replenishment clamp due to improper installation.

[0018] Figure 8 This is an explanatory diagram illustrating a situation in the detection method of Embodiment 1 of the present invention where a faulty installation of the replenishment line to the replenishment clamp is determined when the replenishment pump is rotated in the forward direction.

[0019] Figure 9 This is an explanatory diagram illustrating a situation in the detection method of Embodiment 1 of the present invention where, when the replenishment pump is reversed, it is determined that there is a problem with the installation of the replenishment line to the replenishment clamp.

[0020] Figure 10 This is a flowchart illustrating another example of the pre-filling step in the hemodialysis apparatus according to Embodiment 2 of the present invention.

[0021] Figure 11 This is a flowchart of the detection method according to Embodiment 2 of the present invention.

[0022] Figure 12 This is an explanatory diagram showing the situation where the infusion pump is rotated forward in a detection method according to one aspect of the present invention, performed by the hemodialysis apparatus of Embodiment 2 of the present invention.

[0023] Figure 13 This is an explanatory diagram illustrating the case where the infusion pump is reversed during a detection method according to one aspect of the present invention, performed by the hemodialysis apparatus of Embodiment 2 of the present invention. Detailed Implementation

[0024] In the above-described method for detecting whether there is improper installation of the rehydration tubing in the hemodialysis apparatus of the present invention (hereinafter also referred to as "the detection method of the present invention"), in order to determine whether there is improper installation of the rehydration tubing to the rehydration clamp, the rehydration clamp is set to a closed state, blocking any part of the flow path downstream of the venous lumen, and the rehydration pump is rotated. If there is no improper installation of the rehydration tubing to the rehydration clamp, the fluid will not travel back and forth between the rehydration tubing and the venous side tubing, and the venous pressure measured by the venous pressure sensor will not change. On the other hand, when there is improper installation such as forgetting to install the rehydration tubing to the rehydration clamp, or the flow path of the rehydration tubing not being properly closed due to the rehydration clamp, even if the rehydration clamp is closed by the control unit, fluid will flow between the rehydration tubing and the venous side tubing. Therefore, depending on the rotation direction of the rehydration pump, positive or negative pressure is applied to the fluid in the venous side tubing, and thus the venous pressure measured by the venous pressure sensor changes, rises, or falls before and after the rotation of the rehydration pump.

[0025] Furthermore, since the blood circuit and fluid resuscitation tubing are primarily constructed using flexible, soft tubing, and the venous pressure sensor measures air pressure, the venous pressure measured by the venous pressure sensor will fluctuate slightly (e.g., approximately ±2 mmHg) due to vibrations in the hemodialysis device, changes in ambient temperature, etc. These minute fluctuations are not included in the "variation of venous pressure" as defined in this invention.

[0026] In this invention, for example, when the hemodialysis apparatus of this invention does not have a drain line connected to the venous side tubing for discharging dialysate as pre-filling fluid, any portion of the flow path downstream of the venous lumen can be any portion of the venous side tubing downstream of the venous lumen. When the hemodialysis apparatus of this invention includes the drain line and a pre-filling clamp for opening and closing the flow path of the drain line, any portion of the flow path downstream of the venous lumen can also be, for example, any portion of the drain line. Furthermore, in this specification, "upstream side" and "downstream side" are based on the flow direction of the fluid during treatment using the hemodialysis apparatus of this invention.

[0027] In the hemodialysis apparatus and detection method of the present invention, the determination unit can determine whether there is a problem with the installation of the infusion tubing to the infusion clamp based on the change in venous pressure corresponding to the rotation direction of the infusion pump. In the hemodialysis apparatus and detection method of the present invention, since the detection of such installation defects can be performed, leakage of blood from the blood circuit to the infusion tubing during the dialysis step can be prevented.

[0028] In the hemodialysis apparatus and detection method of the present invention, from the viewpoint of accuracy, the determination of the presence or absence of installation defects is preferably performed after the dialysate, which serves as pre-filling fluid, is filled into the blood circuit and the replenishment line, and more preferably after a leak check is performed on the blood circuit filled with the dialysate, which serves as pre-filling fluid, and the pre-filling fluid is filled into the replenishment line.

[0029] In one embodiment of the hemodialysis apparatus and detection method of the present invention, the infusion pump is rotated X times to determine whether there is a malfunction. If the absolute value of the difference between the venous pressure P1 immediately after the infusion pump rotates X times and the venous pressure P0 before the infusion pump rotates X times is greater than or equal to a threshold I preset in the determination unit, the determination unit determines that there is a malfunction. If the absolute value is less than the threshold I, the determination unit determines that there is no malfunction. With this structure, the presence or absence of a malfunction can be determined with high accuracy.

[0030] In one embodiment of the hemodialysis apparatus and detection method of the present invention, the threshold I is set to a value smaller than the absolute value of the difference obtained by subtracting venous pressure P0 from venous pressure P1, where venous pressure P1 is the venous pressure immediately after the infusion pump has been rotated X times under the same conditions as determining whether there is a malfunction, except that the infusion clamp installed in the infusion line is in the open state, and venous pressure P0 is the venous pressure before the X rotations. According to this structure, the presence or absence of a malfunction can be determined with high precision.

[0031] In one embodiment of the hemodialysis apparatus and detection method of the present invention, a venous side tubing clamp is further included. This clamp is disposed downstream of the venous lumen in the venous side tubing to open and close the flow path of the venous side tubing. With the flow path of the venous side tubing blocked by the clamp, rotation is performed to determine whether the infusion pump is improperly installed. By rotating the infusion pump to determine whether it is improperly installed while the flow path of the venous side tubing is blocked by the clamp, the presence of improper installation can be determined with high accuracy.

[0032] In one embodiment of the hemodialysis apparatus and detection method of the present invention, the downstream end of the infusion tubing can be attached to or detached from the blood circuit at a position upstream of the venous lumen. Furthermore, the determination unit can also determine whether the connection status of the infusion tubing to the blood circuit is appropriate. After determining whether there is any installation malfunction, the control unit actuates the infusion clamp from a closed state to an open state. Based on the change in venous pressure caused by rotating the infusion pump in this state, the determination unit determines whether the connection status is appropriate.

[0033] Based on this structure, it is possible to determine whether there is a problem with the installation of the fluid infusion line to the fluid infusion clamp and whether the connection status of the fluid infusion line to the blood circuit is appropriate.

[0034] In one embodiment of the hemodialysis apparatus and the detection method of the present invention, the infusion pump is rotated Y-shaped to determine whether the connection state is appropriate, and the venous pressure P is measured immediately after the infusion pump has just rotated Y-shaped. 11 Subtract the venous pressure P before the Y-rotation of the infusion pump 10 If the absolute value of the difference is above the threshold II preset in the determination unit, the determination unit determines that the connection state is appropriate; if it is below the threshold II, the determination unit determines that the connection state is inappropriate.

[0035] Based on this structure, it is possible to determine with high precision whether the connection status of the infusion tubing to the blood circuit is appropriate. Additionally, to ensure proper connection from venous pressure P... 11 Subtract venous pressure P 10 The absolute value of the difference obtained is above threshold II, which requires not only a proper connection between the infusion tubing and the blood circuit, but also appropriate infusion pump-based delivery. Therefore, from venous pressure P 11 Subtract venous pressure P 10 If the absolute value of the difference obtained is above the threshold II, it can be confirmed that the installation status of the replenishment pipeline to the replenishment pump is also appropriate while determining whether the connection status is appropriate.

[0036] In one embodiment of the hemodialysis apparatus and the detection method of the present invention, the threshold II is set to a value less than the absolute value of the following difference, under the same conditions as determining the suitability of the connection state: the venous pressure P immediately after the infusion pump has been rotated Y revolutions. 11 Subtract the venous pressure P before rotation Y. 10 The difference is obtained. Based on this structure, it is possible to determine with high precision whether there is any installation malfunction.

[0037] In one embodiment of the hemodialysis apparatus and detection method of the present invention, the hemodialysis apparatus includes a notification device. If, in determining whether an installation malfunction exists, or in determining whether the connection is suitable, the connection is unsuitable, the control unit activates the notification device to issue a notification. This structure reduces the attentional burden on the operator preparing for dialysis treatment.

[0038] Hereinafter, preferred embodiments of the hemodialysis apparatus and the detection method of the present invention will be described in detail with reference to the accompanying drawings.

[0039] (Implementation Method 1) Figure 1 This is a diagram illustrating a schematic structure of one embodiment of the hemodialysis apparatus of the present invention. Figure 2 It means Figure 1 The diagram shows a block diagram of the structure of a hemodialysis device. The hemodialysis device 100 of this method is configured to purify the blood of patients with renal insufficiency or drug poisoning, remove excess water from the blood, and replenish the blood with dialysate as a replacement fluid as needed.

[0040] The hemodialysis apparatus 100 is an automated dialysis device that continuously and automatically performs the pre-filling step, blood removal step, fluid replenishment step, and blood return step, which are described in detail later, by controlling the flow of dialysate within the control circuit. The detection method of the present invention, performed using the hemodialysis apparatus of the present invention, can be applied to the pre-filling step in one embodiment.

[0041] like Figure 1 As shown, the hemodialysis apparatus 100 includes a blood purifier 120, a blood circuit 110, an overflow line (drainage line) 113, a dialysate circuit 130, a refill line 140, and a ventilation line 112e connected to the venous lumen 112b constituting the blood circuit 110. Additionally, the hemodialysis apparatus 100 includes a venous pressure sensor 112f installed in the ventilation line 112e, and a hemodialysis apparatus body (hereinafter also referred to as a "control console") C including a control device 160 and a notification device 150.

[0042] The blood purifier 120 is a conventionally known blood purifier that uses a dialyzer and a blood filter. Inside the cylindrical container body 121, there is a hollow fiber (not shown) that functions as a blood purification membrane. This hollow fiber divides the container body 121 into an inner and outer side; the inner side is the blood flow path, and the outer side is the dialysate flow path. The container body 121 has a blood inlet 122a and a blood outlet 122b communicating with the blood circuit 110, and a dialysate inlet 123a and a dialysate outlet 123b communicating with the dialysate circuit 130.

[0043] The blood circuit 110 is a circuit used to circulate blood in a patient, and is mainly composed of a flexible, transparent, soft tube that allows fluid to flow through. The blood circuit 110 includes an arterial side tube 111 and a venous side tube 112.

[0044] One end of the arterial side conduit 111 is connected to the blood inlet 122a of the blood purifier 120, and the other end of the arterial side conduit 111 includes an arterial side connector 111a that can be connected to a blood-drawing needle (not shown) punctured into the patient's blood vessel (artery).

[0045] An arterial side air bubble detector 111c and a blood pump 111b are installed in the arterial side conduit 111. The arterial side air bubble detector 111c is positioned closer to the arterial side connection 111a than the blood pump 111b, and detects the presence or absence of air bubbles in the arterial side conduit 111. The detection result is transmitted to the control unit 161 of the control device 160 (see reference). Figure 2In the arterial side tubing 111, for example, a downstream position (closer to the blood inlet 122a of the blood purifier 120) of the portion installed on the blood pump 111b is provided, for example, a port 111d for connecting the downstream end of the infusion tubing 140.

[0046] The blood pump 111b delivers blood, pre-filled fluid, and other liquids from the arterial side conduit 111 by rotating the flexible tube that forms the arterial side conduit 111 with rollers. The blood pump 111b is controlled by the control device 160, which can change its rotation direction, rotation speed, etc.

[0047] The venous side tubing 112 includes a venous side connector 112a, one end of which is connected to the blood outlet 122b of the blood purifier 120, and the other end can be connected to a return blood needle (not shown) inserted into the patient's blood vessel (vein).

[0048] The venous side conduit 112 includes a venous lumen 112b, and a venous side air bubble detector 112c and an air bubble detector clamp 112d are installed in the venous side conduit 112. The venous lumen 112b stores a predetermined amount of blood, for example, about 20 ml, to remove air bubbles, coagulated blood, etc., that may have entered the venous side conduit 112b. The venous side air bubble detector 112c is positioned downstream of the venous lumen 112b (on the side of the venous side connection 112a) to detect the presence or absence of air bubbles within the conduit. The detection result is transmitted to the control unit 161 of the control device 160.

[0049] The bubble detector clamp 112d is positioned downstream of the vein-side bubble detector 112c (on the vein-side connection 112a side). The bubble detector clamp 112d is controlled to open and close by the control unit 161 of the control device 160 based on the bubble detection result of the vein-side bubble detector 112c. The bubble detector clamp 112d is in a closed state when a bubble is detected by the vein-side bubble detector 112c, and is normally in an open state. The bubble detector clamp 112d can also function as a vein-side tubing clamp; when not detecting a bubble, this clamp, under the control of the control unit 161, can open and close the flow path downstream of the vein lumen 112b in the vein-side tubing. Other than when air bubbles are detected, examples include the rotation of the infusion pump 140a, which is used to determine whether there is a problem with the installation of the infusion line 140 to the infusion clamp 140b, as described later, and the rotation of the infusion pump 140a, which is used to determine whether the connection status of the infusion line 140 to the blood circuit 110 is appropriate.

[0050] like Figure 3As shown, the venous lumen 112b includes: a lumen body 1120b for containing liquid; an inlet 1121b connected to a portion of the venous side conduit 112 upstream of the venous lumen 112b, for introducing liquid into the lumen body 1120b; a vent 1122b for allowing gas to flow in or out; an outlet 1123b for discharging liquid from the venous lumen 1112b to an overflow conduit 113; and an outlet 1124b formed at the bottom of the lumen body 1120b for discharging liquid from the venous lumen 1112b to the venous side conduit 112 downstream of the venous lumen 1112b. A ventilator 112e is connected to one end of the ventilator 1122b. A venous pressure sensor 112f (see reference) is installed at, for example, the other end of the ventilator 112e. Figure 1 The venous pressure sensor 112f measures the pressure of the gas in the venous cavity 112b and the ventilation tube 112e as the venous pressure.

[0051] The venous pressure sensor 112f measures the air pressure within the space 1125b of the cavity body 1120b, which changes with the rise or fall of the liquid level in the cavity body 1120b, and the air pressure in the ventilation tube 112e connected to it, as the venous pressure. If the liquid level in the cavity body 1120b rises, the venous pressure rises; if the liquid level falls, the venous pressure falls. The venous pressure sensor 112f is, for example, configured as the main body C of a hemodialysis device, and the other end of the ventilation tube 112e includes a connection point (not shown) to the venous pressure sensor 112f. The venous pressure sensor 112f is, for example, a known sensor configured to continuously output venous pressure at a short cycle of approximately several times per second. The output result of the venous pressure sensor 112f is, for example, transmitted and recorded to the determination unit 162 of the control device 160.

[0052] The arterial side connection 111a and the venous side connection 112a can be in a so-called short-circuit state (bypass connection state) where they are directly connected to each other without passing through the human body.

[0053] An overflow line (also called a "drainage line") 113 is connected to the venous lumen 112b that constitutes the venous side line 112. A pre-filling clamp 113a is installed on the overflow line 113. The overflow line 113 is a line used to drain pre-filling fluid during the pre-filling step. The pre-filling clamp 113a is controlled by the control unit 161 of the control device 160 and can be switched between a closed state (closing the flow path of the overflow line 113) and an open state (opening the flow path).

[0054] Furthermore, the hemodialysis apparatus of the present invention may also be provided without the overflow line 113, wherein the portion of the venous side line 112 downstream of the venous lumen 112b can also function as a drainage line. Specifically, the connection between the arterial side connection 111a and the venous side connection 112a is released, and the pre-filling fluid is discharged from the venous side line 112. In this case, the bubble detector clip 112d or a separately provided venous side line clip (not shown) is preferably controlled by the control unit 161 to perform the same function as the pre-filling clip 113a.

[0055] Blood drawn from the artery of the dialysis patient is pumped by the forward rotation of blood pump 111b and flows through arterial side tubing 111, then into the blood flow path of blood purifier 120. The blood introduced into blood purifier 120 is purified by dialysate flowing through dialysate circuit 130 (described later) via a blood purification membrane. The purified blood in blood purifier 120 then flows through venous side tubing 112 and is returned to the patient's vein.

[0056] The dialysate circuit 130 is used for supplying and discharging dialysate to the blood purifier 120. In this embodiment, as a method for controlling the amount of water removed, a closed-loop capacity control method based on a so-called dual-chamber design is adopted. The dialysate circuit 130 includes: a dialysate delivery section 133, which is a dialysate chamber 1331 as the dual chamber; a dialysate supply line 131a and a dialysate inlet line 132a connected to each other via a supply receiving section 1331a (one chamber) of the dialysate chamber 1331; and a dialysate discharge line 131b and a dialysate outlet line 132b connected to each other via a discharge receiving section 1331b (the other chamber) of the dialysate chamber 1331. The amount of water removed is controlled by discharging dialysate from this closed circuit using a dehydration / reverse filtration pump 135.

[0057] The dialysate delivery unit 133 also includes a dialysate inlet pump 1332 and a dialysate outlet pump 1333. The dialysate inlet pump 1332 delivers dialysate from the supply reservoir 1331a to the hemodialyzer 120, and the dialysate outlet pump 1333 delivers dialysate discharged from the hemodialyzer 120 to the outlet reservoir 1331b. By controlling the dialysate inlet pump 1332 and the dialysate outlet pump 1333, dialysate can be delivered to the hemodialyzer 120 by applying negative or positive pressure to the blood purification membrane. The dialysate inlet pump 1332 and the dialysate outlet pump 1333 are, for example, gear pumps that rotate gears to deliver liquid. The dialysate inlet pump 1332 and the dialysate outlet pump 1333 are controlled by the control unit 161 of the control device 160, and their rotation direction, rotation speed, etc., can be changed.

[0058] The dialysate chamber 1331 is used for temporary storage of dialysate and is made of a rigid container capable of holding a constant volume (e.g., 300 ml to 500 ml) of dialysate. The interior of the container is divided into a supply section 1331a and a drain section 1331b by a soft diaphragm.

[0059] Furthermore, after the pre-charge start button is pressed, the dialysate delivery unit 133 operates continuously, except in cases where delivery is stopped due to an alarm or other reasons, ensuring that the dialysate circulates within the dialysate circuit 130. Additionally, the dialysate delivery unit 133 is not limited to... Figure 1 The structure shown can also be a dialysate delivery unit that is known in the past to constitute a closed-volume control method. For example, it can also include a constant-volume container divided into two or more small chambers and three or more gear pumps.

[0060] The dialysate circuit 130 includes a bypass line 134 connecting the dialysate outlet line 132b and the dialysate drain line 131b. The bypass line 134 includes a water removal / reverse filtration pump 135.

[0061] The dehydration / reverse filtration pump 135 can deliver liquid in two directions: the direction in which the dialysate in the bypass line 134 flows to the dialysate discharge line 131b (dehydration direction) and the direction in which the dialysate flows to the dialysate outlet line 132b (reverse filtration direction). The dehydration / reverse filtration pump 135 is, for example, a plunger pump that delivers liquid by rotating a plunger. The dehydration / reverse filtration pump 135 is controlled by the control unit 161 of the control device 160, and its rotation direction, rotation speed, etc., can be changed.

[0062] One end of the dialysate supply line 131a is connected to the dialysate supply device (not shown), and the other end is connected to the supply container 1331a. The dialysate supply line 131a supplies fresh dialysate to the supply container 1331a.

[0063] The dialysate circuit 130 includes a dialysate inlet line 132a that supplies fresh dialysate to the blood purifier 120. One end of the dialysate inlet line 132a is connected to a supply container 1331a, and the other end is connected to a dialysate inlet 123a of the blood purifier 120, introducing the dialysate contained in the supply container 1331a into the dialysate flow path of the blood purifier 120. A solenoid valve, serving as a dialysate inlet flow path on / off valve 133a, is installed midway through the dialysate inlet line 132a to open and close this flow path. The dialysate inlet flow path on / off valve 133a is controlled by the control unit 161 of the control device 160. Additionally, the upstream end of the upstream replenishment line 140f (described later) is connected midway through the dialysate inlet line 132a.

[0064] One end of the dialysate outlet tubing 132b is connected to the dialysate outlet 123b of the blood purifier 120, and the other end is connected to the drainage collection section 1331b, through which dialysate discharged from the blood purifier 120 is drained. Midway through the dialysate outlet tubing 132b, a solenoid valve is installed as a dialysate outlet flow path on / off valve 133b to open and close the flow path. The dialysate outlet flow path on / off valve 133b is controlled by the control unit 161 of the control device 160.

[0065] One end of the dialysate discharge line 131b is connected to the discharge collection section 1331b, and the used dialysate collected in the discharge collection section 1331b is discharged from the other end.

[0066] By controlling the dialysate delivery unit 133 through the control unit 161, the amount of fresh dialysate supplied from the dialysate supply device (not shown) to the supply container 1331a can be the same as the amount of used dialysate recovered to the discharge container 1331b. For example, with the dialysate inlet pump 1332 and dialysate outlet pump 1333 having the same delivery volume (ml), and the dewatering / reverse filtration pump 135 and the replenishment pump 140a (described later) stopped, the flow rate of dialysate introduced into the blood purifier 120 is the same as the amount of dialysate (discharge) discharged from the blood purifier 120.

[0067] [Reverse Filtering] When the dehydration / reverse filtration pump 135 is driven in a manner that causes the dialysate to flow in the reverse filtration direction, a portion of the drained fluid discharged from the drain reservoir 1331b to the dialysate discharge line 131b is recovered back to the drain reservoir 1331b via the bypass line 134 and the dialysate outlet line 132b. Therefore, the amount of dialysate discharged from the blood purifier 120 is the amount that should be recovered to the drain reservoir 1331b without driving the dehydration / reverse filtration pump 135 (i.e., the amount equal to the amount of dialysate flowing in the dialysate inlet line 132a) minus the amount of dialysate flowing in 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 in the dialysate inlet line 132a, resulting in a smaller amount of dialysate (drained fluid) recovered back to the drain reservoir 1331b via the bypass line 134. Therefore, when the dewatering / reverse filtration pump 135 is driven in such a way that the dialysate flows in the reverse filtration direction, a predetermined amount of dialysate is injected (reverse filtered) into the blood circuit 110 in the blood purifier 120.

[0068] [Water Removal] On the other hand, when the dehydration / reverse filtration pump 135 is driven in a manner that allows the dialysate to flow in the direction of water removal, the amount of dialysate flowing in the dialysate outlet line 132b is the amount of dialysate recovered to the discharge containment section 1331b without driving the dehydration / reverse filtration pump 135 (i.e., the amount of dialysate flowing in the dialysate inlet line 132a) plus the amount of dialysate flowing in the bypass line 134. In other words, the amount of dialysate flowing in the dialysate outlet line 132b is greater than the amount of dialysate flowing in the dialysate inlet line 132a by the amount of dialysate discharged through the bypass line 134 to the dialysate discharge line 131b. Therefore, when the dehydration / reverse filtration pump 135 is driven in a manner that allows the dialysate to flow in the direction of water removal, a predetermined amount of water is removed from the blood in the blood purifier 120.

[0069] The replenishment tubing 140 is a tubing used to supply dialysate as replenishment or prefill fluid from the dialysate circuit 130 to the blood circuit 110. The dialysate is supplied from the dialysate circuit 130, which serves as the replenishment source. The replenishment tubing 140 includes an upstream replenishment tubing 140f integrated into the control console C and a downstream replenishment tubing 140g disposed outside the control console C. The upstream replenishment tubing 140f is connected to, for example, a dialysate inlet tubing 132a in the dialysate circuit 130. When assembling the hemodialysis apparatus 100 described later, the downstream replenishment tubing 140g is connected to the upstream replenishment tubing 140f via a connection port 140e provided by the control console C.

[0070] On the upstream replenishment line 140f, starting from the upstream side (replenishment supply source side), a solenoid valve (replenishment flow path opening and closing valve) 140d for opening and closing the flow path of the upstream replenishment line 140f and a pressure sensor 140c for measuring the hydraulic pressure in the upstream replenishment line 140f are installed in sequence. On the downstream replenishment line 140g, starting from the upstream side (replenishment supply source side), a replenishment pump 140a and a replenishment clamp 140b are installed in sequence.

[0071] When using a dialyzer with a low ultrafiltration rate or a stacked dialyzer that cannot be reverse filtered as the blood purifier 120, it is difficult to inject dialysate into the blood circuit 110 through reverse filtration. Therefore, the replenishment line 140 is used in the pre-filling step, the replenishment step, and the blood return step described later.

[0072] Pressure sensor 140c is used to measure the hydraulic pressure within the replenishment line 140. Pressure sensor 140c is, for example, disposed in the area between the connection port 140e and the replenishment flow path on / off valve 140d in the upstream replenishment line 140f. Pressure sensor 140c is, for example, a known sensor configured to continuously output the pressure within the replenishment line 140 at short intervals of approximately several times per second. The output of pressure sensor 140c is transmitted and recorded to the determination unit 162 of the control device 160.

[0073] The replenishment pump 140a is a pump used to deliver dialysate in the replenishment tubing 140 as replenishment or prefilling fluid to the blood circuit 110. It is a roller pump that delivers fluid by rotating the circuit. The replenishment pump 140a can change its rotation direction, rotation speed, etc. via the control unit 161 of the control device 160.

[0074] The infusion clamp 140b is used to open and close the flow path of the downstream infusion line 140g on the downstream side of the infusion pump 140a. To prevent blood leakage from the blood circuit 110 into the infusion line 140, the infusion clamp 140b is preferably installed near the connection point of the infusion line 140 with the blood circuit. The opening and closing of the infusion clamp 140b is controlled by the control unit 161 of the control device 160.

[0075] When assembling the hemodialysis device 100, one end of the downstream fluid supply line 140g is connected to the fluid supply line connection port 111d of the arterial side line 111, and the portion of the downstream fluid supply line 140g that connects to the blood circuit 110 is mounted on the fluid clamp 140b. Furthermore, the other end of the downstream fluid supply line 140g is connected to the connection port 140e, and the portion of the downstream fluid supply line 140g upstream of the portion mounted on the fluid clamp 140b is mounted on the fluid pump 140a.

[0076] The notifier 150 is controlled by the control device 160 and notifies the medical practitioner of any abnormality in the hemodialysis device 100. For example, if the determination unit 162, which determines whether there is a problem with the installation of the infusion tubing 140 to the infusion clamp 140b, is faulty, the control unit 161, upon receiving this determination result, activates the notifier 150 and causes it to sound.

[0077] The control device 160 consists of an information processing device (computer) that operates according to a prescribed procedure, such as... Figure 2 As shown, it includes a control unit 161 and a determination unit 162. The control device 160 is connected to operation buttons 163 for operator use. The operation buttons 163 include, for example, various setting buttons such as a pre-charge start button and a dialysis start button.

[0078] The control unit 161 operates the various pumps, clamps, and flow path opening and closing valves provided in the hemodialysis apparatus 100, and controls them in each step such as the pre-filling step and the dialysis step. In addition, the control unit 161 activates the notification device 150 when the hemodialysis apparatus 100 is not operating normally.

[0079] The determination unit 162 determines, for example, whether there is a problem with the installation of the infusion tubing 140 to the infusion clamp 140b, based on the venous pressure measured by the venous pressure sensor 112f. Details regarding this determination of the presence or absence of installation defects will be described later.

[0080] The control device 160 controls the operation of the hemodialysis device 100 by executing the control program described below. The steps are: pre-filling step, blood removal step, dialysis step, fluid replacement step, and blood return step.

[0081] The pre-filling step is a preparatory step involving purging, cleaning, and purifying the air in the blood circuit 110, blood purifier 120, dialysis circuit 130, and rehydration tubing 140. The blood removal step involves filling the blood circuit 110 with the patient's blood after puncture with the blood-drawing needle and the blood-returning needle. The dialysis step is a step that purifies the blood by circulating it extracorporeally while simultaneously performing dialysis, following the blood removal step. The rehydration step involves supplying rehydration fluid to the blood circuit while simultaneously filtering the same amount of water as the supplied rehydration fluid using the blood purifier 120; this step is performed when blood pressure drops during dialysis treatment. The blood return step is the step of returning the blood in the blood circuit 110 to the patient's body.

[0082] The determination of whether there is a problem with the installation of the infusion line 140 to the infusion clamp 140b can be performed after the filling step of the pre-filled fluid to the venous side line 112. For example, it can also be performed after the filling step of the pre-filled fluid to the blood circuit 110, before the leak check of the blood circuit 110, and after the filling steps of the pre-filled fluid to the venous side line 112 and the infusion line 140. Preferably, from the viewpoint of improving the accuracy of the determination, the determination is performed after the leak check of the blood circuit 110 filled with dialysate as pre-filled fluid confirms that there is no poor connection at the connection points between the blood circuit 110 and the blood purifier 121, and after the infusion line 140 is filled with pre-filled fluid.

[0083] Next, use Figures 1-9 One aspect of the detection method of the present invention will be described. Figure 4 This is a flowchart illustrating the pre-charging steps of the hemodialysis device 100. Step S10, which occurs before pre-charging (see...). Figure 4In this process, medical personnel assemble the hemodialysis device 100. Specifically, they connect the blood circuit 110 and the dialysate circuit 130 to the blood purifier 120, and connect the arterial side connection 111a and the venous side connection 112a. Regarding the downstream rehydration tubing 140g, one end is connected to the rehydration tubing connection port 111d of the arterial side tubing 111, and the other end is connected to the connection port 140e, and then installed on the rehydration pump 140a. The connection method between the downstream rehydration tubing 140g and the rehydration tubing connection port 111d is not particularly limited and can be the same as conventionally known connection methods. Sometimes, the downstream rehydration tubing 140g is also pre-integrated with the blood circuit 110. Furthermore, various circuits are installed on various bubble detectors, various flow path opening and closing valves (solenoid valves), and various clamps located on the main body C of the hemodialysis device. All flow path opening and closing valves and clamps are in the open state.

[0084] exist Figure 4 In step S20 shown, the medical practitioner operates the pre-charge start button, for example, by starting the pre-charge step through automatic control. When the pre-charge start button is pressed, pre-charge begins with the flow rate of various pumps, pre-charge amount, opening and closing status of various flow path valves (solenoid valves), and opening and closing status of various clamps preset by the internal setting function of the control unit 161.

[0085] In step S30, air in the blood circuit 110 is removed by injecting dialysate as a pre-filling fluid into the blood circuit 110, and the blood circuit 110 is then filled with pre-filling fluid. As a method for injecting pre-filling fluid into the blood circuit 110, depending on the ease of reverse filtration of the blood purifier 120, either a method of injecting dialysate via the blood purifier 120 or a method of injecting dialysate via the replenishment line 140 is used.

[0086] exist Figure 1 The diagram illustrates a method of injecting dialysate as a pre-filling fluid into the blood circuit 110 via the replenishment line 140. For example... Figure 1 As shown, various flow path opening and closing valves and various clamps are in the open state, enabling the dialysate inlet pump 1332 and dialysate outlet pump 1333 to operate, and also enabling the dewatering / reverse filtration pump 135, replenishment pump 140a, and blood pump 111b to operate. Figure 1 As shown, the blood pump 111b operates in the opposite direction to that during dialysis, that is, it delivers the liquid in the arterial side tubing 111 upstream of the direction of blood flow during dialysis.

[0087] For example, by setting the delivery rate of the dialysate inlet pump 1332 and the dialysate outlet pump 1333 to 500 ml / min, the delivery rate of the dewatering / reverse filtration pump 135 and the replenishment pump 140a to 400 ml / min, and the delivery rate of the blood pump 111b to 360 ml / min, the dialysate, which serves as the pre-filling solution, is directly supplied to the arterial side tubing 111 and discharged from the overflow tubing 113. In this way, while removing air from the blood circuit 110, dialysis circuit 130, replenishment tubing 140, and blood purifier 120, the circuits are cleaned, and the pre-filling solution is filled into the blood circuit 110, dialysis circuit 130, replenishment tubing 140, and blood purifier 120 (step 30).

[0088] After the blood circuit 110 and the blood purifier 120 are filled with pre-filled fluid, a leak check (connection status detection) of the blood circuit 110 is performed in step S40. In the leak check step of the blood circuit 110, for example, the flow path of the drain line 113 is blocked, the bubble detector clamp 112d is closed, and the pre-filled fluid is injected into the blood circuit 110 via the blood purifier 120 or via the replenishment line 140. If there is no leak, the air pressure in the venous lumen 112b and the ventilation line 112e increases. Then, based on the venous pressure measured by the venous pressure sensor 112f, the connection status of the blood circuit 110 can be detected, such as whether there is a poor connection between the blood circuit 110 and the blood purifier 120. The leak check method is not limited to this and can also be a conventionally known method.

[0089] Next, in step S50, based on the changes in venous pressure accompanying the rotation of the infusion pump 140a, a determination is made as to whether there is any improper installation of the infusion tubing 140 to the infusion clamp 140b. Details of the determination will be described later.

[0090] After step S50, the pressure in each circuit is released by opening the clamps and flow path valves, thus ending the pre-charging step.

[0091] In addition, in use Figure 4 In the illustrated example, during the pre-charging step, immediately after the leak check of the blood circuit 110 (step S40), a determination is made regarding the presence or absence of improper installation of the replenishment line 140 to the replenishment clamp 140b (step S50). However, other checks may be performed as needed after step S40 and before step S50. Additionally, after step S50, if necessary, after performing further checks, the pressure in each circuit may be released, and the pre-charging step may be terminated.

[0092] Next, refer to Figure 5 Flowchart and Figures 6-9 A detection method according to one aspect of the present invention will be described in detail.

[0093] exist Figure 4 After the leakage check (connection status detection) (step S40) of the blood circuit 110 in the pre-charging step shown, in Figure 5 In step S51 shown, as Figure 6 As shown, with the pre-fill clamp 113a and the replenishment clamp 140b in the closed state and the replenishment flow path on / off valve 140d in the open state, the control unit 161 performs the opening and closing operations as needed. When the pre-fill clamp 113a is in the closed state, the flow path downstream of the venous lumen 112b is blocked. When the replenishment flow path on / off valve 140d is in the open state, the flow path upstream of the portion of the replenishment line 140 installed on the replenishment pump 140a is open to the dialysate circuit 130.

[0094] Next, in step S52, the replenishment pump 140a is rotated, for example, in the forward direction (see reference). Figure 6 ) or reverse (see Figure 7 0.1 revolutions. Forward rotation refers to the direction of rotation that supplies dialysate to the blood circuit, while reverse rotation refers to the opposite direction of rotation. If there is no improper installation of the downstream rehydration tubing 140g to the rehydration clamp 140b, the flow path of the downstream rehydration tubing 140g will be blocked by the rehydration clamp 140b, and there will be no fluid flow between the blood circuit 110 and the rehydration tubing 140, so the venous pressure measured by the venous pressure sensor 112f will remain unchanged.

[0095] On the other hand, in the event of improper installation, when the infusion pump 140a is rotated in the forward direction, the fluid in the infusion tubing 140 is delivered to the blood circuit 110 side, including the venous side tubing 112, thus increasing the venous pressure (see reference). Figure 8 When the infusion pump 140a is reversed, fluid in the blood circuit 110 is delivered to the infusion tubing 140 side, thus lowering the venous pressure (see reference). Figure 9 ).

[0096] The rotation number (times) of the infusion pump 140a to determine whether there is any installation malfunction is set to 0.1 revolutions in the above manner, but it is not limited to this in the present invention. The rotation number (times) of the infusion pump 140a is set to a level that can suppress the load on the infusion tubing 140 and the infusion clamp 140b due to positive or negative pressure, and can effectively detect the venous pressure fluctuation as a venous pressure change by the venous pressure sensor 112f in the event of the installation malfunction.

[0097] Next, in step S53, a determination is made regarding whether or not there is a malfunction in the installation, based on the change in venous pressure caused by the rotation of the infusion pump 140a in step S52. Specifically, if the absolute value of the difference between the venous pressure P1 immediately after the infusion pump 140a rotates by 0.1 revolutions and the venous pressure P0 before the rotation is less than a preset threshold I in the determination unit 162 (i.e., not exceeding threshold I), the determination unit 162 determines that there is no malfunction (step S54). If the difference is not less than threshold I (i.e., exceeding threshold I), the determination unit 162 determines that there is a malfunction. Upon receiving the determination result of a malfunction, the control unit 161 activates the notification device 150 to notify the medical practitioner (step S55), and the determination ends. In this way, by setting a threshold I in advance and using it as a judgment factor (judgment benchmark), compared with the case where only the rise or fall of venous pressure P0 before relative rotation is used as a judgment factor, false judgments can be reduced, and the above-mentioned installation failure can be detected with good accuracy.

[0098] Examples of venous pressure P0 include the venous pressure before the infusion pump 140a is about to rotate in step S52, or the leakage check step in the blood circuit 110. Figure 4 The venous pressure obtained in step S40). The venous pressure P0 is, for example, -50 to 50 mmHg.

[0099] The threshold I can be determined, for example, by being preset in the determination section 162 of the hemodialysis device as follows.

[0100] Threshold I is set to a value smaller than the absolute value of the following difference, which is the absolute value of the difference obtained by subtracting the venous pressure p0 (e.g., 0 mmHg) before rotating the infusion pump 140a by X revolutions (e.g., 0.1 revolutions) from the venous pressure p1 after rotating the infusion clamp 140a by X revolutions (e.g., 0 mmHg) under the same conditions as determining the presence or absence of installation malfunction, except that the infusion clamp 140b is in the open state. However, the venous pressures p1 and p0 used to determine threshold I are based on values ​​measured with the downstream infusion tubing 140g properly installed to the infusion clamp 140b. The venous pressure p1 in the forward rotation case is, for example, 70 mmHg, and the venous pressure p1 in the reverse rotation case is, for example, -70 mmHg, and the absolute value of the difference p1-p0 is 70 mmHg. Alternatively, the threshold I can be determined by considering the sensitivity of the venous pressure sensor 112f, but it is preferable to set it to a value smaller than the absolute value. If the venous pressure sensor 112f is a typical pressure sensor, it is preferably a value in the range of 20 mmHg or more and less than 60 to 70% of the absolute value mentioned above.

[0101] Alternatively, even if the flow path of the downstream infusion line 140g is properly blocked by the infusion clamp 140b, the venous pressure may still fluctuate slightly. Therefore, it is preferable to set the threshold I to a value larger than this fluctuation. Specifically, if the rotation time is X revolutions for S seconds, the pressure change over S seconds is confirmed without rotating the infusion pump 140a. If this change is, for example, about ±Z mmHg, the threshold I is preset to a value greater than, for example, 1.5 times the absolute value of the change Z. This reduces the risk of false detection and is preferable. More specifically, if the rotation time is 0.1 revolutions for 1 second, the pressure change over 1 second is confirmed without rotating the infusion pump 140a. If this change is, for example, about ±2 mmHg, the threshold I is set to a value greater than, for example, 1.5 times the absolute value of the change, for example, 6 mmHg.

[0102] According to the hemodialysis apparatus 100 described above and the detection method of one aspect of the present invention, it is possible to automatically determine whether there is any improper installation of the downstream replenishment tubing 140g to the replenishment clamp 140b during the pre-filling step. Therefore, leakage of blood from the blood circuit to the replenishment tubing during the dialysis step can be prevented.

[0103] (Implementation Method 2) Figure 12 as well as Figure 13 The hemodialysis apparatus shown in this embodiment, except for its ability to determine the suitability of the connection between the fluid replenishment line 140 and the blood circuit 110, has the same structure as the dialysis apparatus of Embodiment 1. Therefore, the general structure of the hemodialysis apparatus of this embodiment is also similar to that of the apparatus in Embodiment 1. Figure 1 The structures shown are the same, in Figure 12 and Figure 13 In this embodiment, components identical to those in the dialysis apparatus of Embodiment 1 are labeled with the same part numbers, and their descriptions are omitted. Furthermore, the block diagram of the hemodialysis apparatus of this embodiment is also identical to... Figure 2 The diagram is identical to that shown, therefore a block diagram of the hemodialysis device of this method is omitted. Details regarding the determination of whether the connection between the fluid refill line 140 and the blood circuit 110 is appropriate will be described later.

[0104] Figure 10 This is a flowchart illustrating the pre-filling step of the hemodialysis device according to this invention. Figure 11This is a flowchart of the detection method of this embodiment of the present invention. In the determination of whether there is a problem with the installation of the downstream replenishment tubing 140g to the replenishment clamp 140b (step S53), after determining that there is no problem (step S54), the control unit 161 controls the replenishment clamp 140b to open from a closed state. Then, the replenishment pump 140a is rotated, and the determination unit 162 determines whether the connection between the replenishment tubing 140 and the blood circuit 110 is appropriate (steps S61-S65). Otherwise, it is the same as the detection method of Embodiment 1. Therefore, in Figure 10 and Figure 11 In this document, the same reference numerals are used for the steps that are the same as those in the detection method of Embodiment 1, and their descriptions are omitted.

[0105] exist Figure 10 In the flowchart illustrating the pre-filling step, steps S10 to S50 are the same as those in (Embodiment 1). In the detection method of this embodiment, after step S50, which determines the installation status of the replenishment line 140 to the replenishment clamp 140b, and before releasing the pressure in each circuit by setting each clamp and the flow path opening / closing valve to the open state, a determination is made as to whether the connection status between the replenishment line 140 and the blood circuit 110 is appropriate (step S60).

[0106] Figure 11 This is a flowchart of the detection method of this embodiment, but steps S51 to S55 are the same as those in (Embodiment 1). In the detection method of this embodiment, in the determination of whether there is a faulty installation of the fluid replenishment line 140 to the fluid replenishment clamp 140b (step S53), if it is determined that there is no faulty installation, the next step S61 is performed to determine the connection status between the fluid replenishment line 140 and the blood circuit 110.

[0107] like Figure 11 As shown, in step S61, the control unit 161 changes the liquid replenishment clamp 140b from the closed state to the open state. Next, as... Figure 12 As shown, the infusion pump 140a is rotated forward by, for example, 0.1 revolutions. Since the infusion clamp 140b is open, if the downstream infusion line 140g is properly connected to the infusion line connection port 111d of the arterial side line 111, the fluid in the infusion line 140 is delivered to the blood circuit 110 side, thus increasing the venous pressure. When the infusion pump 140a is rotated backwards by, for example, 0.1 revolutions, as... Figure 13 As shown, the fluid in the blood circuit 110 is delivered to the infusion line 140 side, thus reducing the venous pressure.

[0108] On the other hand, if the connection status between the downstream rehydration tubing 140g and the rehydration tubing connection port 111d is inappropriate, for example, if the rehydration tubing 140 is forgotten to be connected to the blood circuit 110, even if the rehydration pump 140a is rotated forward in step S62 (see... Figure 12 ) or reverse (see Figure 13 There is no fluid flow between the infusion line 140 and the blood circuit 110, and the venous pressure measured by the venous pressure sensor 112f remains unchanged. Furthermore, the venous pressure measured by the venous pressure sensor 112f is independent of the presence or absence of rotation of the infusion pump 140a. It may sometimes fluctuate slightly due to vibrations of the hemodialysis apparatus, changes in ambient temperature, etc., but as described above, these slight fluctuations are not included in the "fluctuation of venous pressure" in this invention.

[0109] The number of rotations of the infusion pump 140a used to determine whether the connection state is suitable is set to 0.1 revolutions in the above-described manner, but it is not limited to this in the present invention. The number of rotations of the infusion pump 140a is set to a degree that allows it to be well detected by the venous pressure sensor 112f as a change in venous pressure when the connection state is suitable.

[0110] Next, in step S63, the suitability of the connection state is determined based on the change in venous pressure caused by the rotation of the infusion pump 140a in step S62. Specifically, after rotating the infusion pump 140a by, for example, 0.1 revolutions, the venous pressure P immediately after the infusion pump 140a has just rotated by 0.1 revolutions is determined. 11 Subtract the intravenous pressure P before the infusion pump starts rotating 10 If the absolute value of the difference is above the preset threshold II in the determination unit 162, the determination unit 162 determines that the connection state is suitable (step S64); if it is below the threshold II, the determination unit 162 determines that the connection state is unsuitable. The control unit 161, having obtained the determination result of an unsuitable connection state, activates the notification device 150 to notify the medical practitioner (step S65), ending the determination. Thus, by presetting the threshold II and using it as a reference, and comparing it only with the venous pressure P before rotation... 10 Compared to using rising or falling as the determining factor, this method can reduce misjudgments and accurately determine whether the installation state is suitable or not.

[0111] As venous pressure P 10 Examples include the venous pressure before the infusion pump 140a is rotated in step S52 or S62, and the leak check step in the blood circuit 110. Figure 10 The venous pressure obtained in step S40). Venous pressure P 10 For example, 0 mmHg.

[0112] Threshold II can be determined, for example, by being preset in the determination section 162 of the hemodialysis device as follows.

[0113] Threshold II is set to be the venous pressure P immediately after rotating the infusion pump 140a by Y revolutions (e.g., 0.1 revolutions) under the same conditions as determining whether the connection state is suitable or not. 11 Subtract the venous pressure P before rotation Y. 10 (For example, 0 mmHg) and the absolute value of the difference is smaller. However, the venous pressure P used to determine threshold II is smaller. 11 and venous pressure P 10 The value was measured under the premise that the downstream infusion tubing 140g was properly connected to the infusion tubing connection port 111d. Venous pressure P under forward rotation. 11 For example, 70 mmHg, the venous pressure P in the reverse case. 11 For example, -70 mmHg, the above difference P 11 -P 10 The absolute values ​​are 70 mmHg. Threshold II can also be determined by considering the sensitivity of the venous pressure sensor 112f, but it is preferably set to a value smaller than this absolute value, preferably a value in the range of 20 mmHg or more and below 60 to 70% of the absolute value.

[0114] In the hemodialysis device of this embodiment and the detection method of this invention described above, after determining that there is no improper installation of the fluid replenishment line to the fluid replenishment clamp, it can be confirmed that the connection status between the fluid replenishment line 140 and the blood circuit 110 is appropriate.

[0115] Additionally, during the rotation of the replenishment pump 140a, which is used to determine whether the connection status is appropriate, in order to make the difference P 11 -P 10 For the absolute value to exceed threshold II, the replenishment line 140 must be properly installed in the replenishment pump 140a. Therefore, by confirming that the connection is appropriate, it can also be confirmed that the replenishment line 150 is properly installed in the replenishment pump.

[0116] The 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 appropriately modified as follows.

[0117] In Embodiments 1 and 2 described above, when the bubble detector clamp 112d is in a closed state, and the flow path in the venous side tubing is blocked at a position downstream of the venous lumen, rotation of the replenishment pump 140a for determining the presence or absence of the installation malfunction (step S52) and rotation of the replenishment pump 140a for determining the suitability of the connection state (step S62) are performed. However, when the pre-filling clamp 113a installed in the drainage tubing 113 is in a closed state, blocking the flow path downstream of the venous lumen, the bubble detector clamp 112d can be in either a closed or open state in steps S52 and / or S62. Compared to the open state, when the flow path in the venous side tubing is blocked by the bubble detector clamp 112d downstream of the venous lumen, the state in steps S52 and S62 (see...) Figure 5 , Figure 11 It is preferred because it has good responsiveness to changes in venous pressure when the infusion pump 140a rotates.

[0118] In Embodiments 1 and 2 described above, with the dialysate inlet flow path on / off valve 133a in the closed state and the flow path of the dialysate inlet tubing 132a blocked, rotation is performed to determine whether the replenishment pump 140a is improperly installed (step S52), and rotation is performed to determine whether the connection state of the replenishment pump 140a is appropriate (step S62). However, the dialysate inlet flow path on / off valve 133a can be either in a closed state or an open state. For example, compared to the open state, the state of blocking the flow path of the dialysate inlet tubing 132a using the dialysate inlet flow path on / off valve 133a results in better responsiveness to changes in venous pressure when the replenishment pump 140a is rotated in steps S52 and S62, and is therefore preferred.

[0119] 100 hemodialysis devices 110 Blood Circuit 111b Blood Pump 113 Overflow line (drainage line) 113a Precharge Clip 112b Venous lumen 112d Bubble Detector Clip 112e Vent line 112f venous pressure sensor 120 Blood Purifier 130 Dialysis fluid circuit 133 Dialysis Solution Delivery Section 133a Dialysis fluid inlet flow path on / off valve 133b Dialysis fluid discharge flow path on / off valve 135 Water Removal / Reverse Filter Pump 134 Bypass pipe 140 fluid replenishment line 140a replenishment pump 140b Fluid Replacement Clip 140c pressure sensor 140d replenishment flow path on / off valve 150 Notifier 161 Control Department 162 Judgment Department C. Control console (main unit)

Claims

1. A hemodialysis apparatus characterized by comprising: a blood purification device in which a blood purification membrane is built in; a dialysate circuit; a blood circuit including an arterial side tube and a venous side tube including a venous chamber; a venous pressure sensor that measures a pressure of gas in the venous chamber as a venous pressure; a substitution tube that supplies dialysate as a substitution fluid from the dialysate circuit to the blood circuit; a substitution pump to which the substitution tube is attached; a substitution clamp that opens and closes a flow path of the substitution tube on a downstream side from a portion of the substitution tube to which the substitution pump is attached; and a control device including a control section that controls opening and closing of the substitution clamp and operation of the substitution pump, and a determination section that determines whether or not there is a failure in attachment of the substitution tube to the substitution clamp, wherein a flow path on an upstream side from the portion of the substitution tube to which the substitution pump is attached is open to the dialysate circuit, and in a state in which the substitution clamp is in a closed state and a flow path on a downstream side from the venous chamber is occluded at any position, the determination section determines whether or not there is the failure in attachment based on a change in the venous pressure caused by rotation of the substitution pump.

2. The hemodialysis apparatus according to claim 1, wherein the any position of the flow path on the downstream side from the venous chamber is a portion of the venous side tube on the downstream side from the venous chamber, or any position of a drain tube connected to the venous side tube.

3. The hemodialysis apparatus according to claim 1 or 2, wherein in order to determine whether or not there is the failure in attachment, the substitution pump is rotated by X revolutions, and in a case where an absolute value of a difference obtained by subtracting a venous pressure P0 before the substitution pump is rotated by X revolutions from a venous pressure Pl immediately after the substitution pump is rotated by X revolutions is equal to or greater than a threshold value I that is set in advance in the determination section, the determination section determines that there is the failure in attachment, and in a case where the absolute value of the difference is less than the threshold value I, the determination section determines that there is no failure in attachment.

4. The hemodialysis apparatus according to claim 3, wherein the threshold value I is set to a value smaller than an absolute value of a difference obtained by subtracting a venous pressure p0 before the substitution pump is rotated by X revolutions from a venous pressure pl immediately after the substitution pump is rotated by X revolutions in the same conditions as the determination of whether or not there is the failure in attachment except that the substitution clamp attached to the substitution tube is set to an open state.

5. The hemodialysis apparatus according to any one of claims 1 to 4, wherein a downstream end of the substitution tube is detachable with respect to the blood circuit at a position on an upstream side from the venous chamber in the blood circuit, the determination section is further capable of determining a connection state of the substitution tube to the blood circuit, and after a determination result that there is no failure in attachment is obtained, in a state in which the substitution clamp is caused to operate to an open state by the control section, the determination section determines whether or not the connection state is appropriate based on a change in the venous pressure caused by rotation of the substitution pump.

6. The hemodialysis apparatus according to claim 5, wherein the control section is capable of causing the substitution pump to rotate by X revolutions in order to determine whether or not there is the failure in attachment, and in a case where an absolute value of a difference obtained by subtracting a venous pressure P0 before the substitution pump is rotated by X revolutions from a venous pressure Pl immediately after the substitution pump is rotated by X revolutions is equal to or greater than a threshold value I that is set in advance in the determination section, the determination section determines that there is the failure in attachment, and in a case where the absolute value of the difference is less than the threshold value I, the determination section determines that there is no failure in attachment.

7. The hemodialysis apparatus according to claim 6, wherein the control section is capable of causing the substitution pump to rotate by X revolutions in order to determine whether or not there is the failure in attachment, and in a case where an absolute value of a difference obtained by subtracting a venous pressure p0 before the substitution pump is rotated by X revolutions from a venous pressure pl immediately after the substitution pump is rotated by X revolutions is equal to or greater than a threshold value I that is set in advance in the determination section, the determination section determines that there is the failure in attachment, and in a case where the absolute value of the difference is less than the threshold value I, the determination section determines that there is no failure in attachment. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ The substitution pump is rotated by Y rotations for determining whether the connection state is appropriate, and the venous pressure P immediately after the substitution pump is rotated by Y rotations 11 The venous pressure P before the substitution pump is rotated by Y rotations is subtracted 10 If the absolute value of the difference thus obtained is equal to or greater than a threshold value II set in advance in the determination unit, the determination unit determines that the connection state is appropriate, and if the absolute value of the difference is less than the threshold value II, the determination unit determines that the connection state is inappropriate. ​ The threshold value II is set to a value smaller than the absolute value of the difference between the venous pressure p just after the substitution fluid pump is rotated by Y rotations from the condition that the substitution fluid line is connected to the blood line and the same condition as the determination of whether the connection is appropriate 11 Subtracting the venous pressure p before the rotation by Y rotations 10 The absolute value of the difference thus obtained.

8. The hemodialysis device according to any one of claims 1 to 7, wherein the determination of the presence or absence of the poor installation is performed after the dialysate as the priming liquid is filled in the blood circuit and the replacement fluid line.

9. A method of detecting poor installation of a replacement fluid line of a hemodialysis device, characterized by comprising: the hemodialysis device including: a blood purification device in which a blood purification membrane is built in; a dialysate circuit; a blood circuit including: an arterial side line; and a venous side line including a venous chamber; a venous pressure sensor that measures a pressure of gas in the venous chamber as a venous pressure; a replacement fluid line that supplies dialysate as a replacement fluid from the dialysate circuit to the blood circuit; a replacement fluid pump to which the replacement fluid line is installed; a replacement fluid clamp that opens and closes a flow path of the replacement fluid line on a downstream side of a portion of the replacement fluid line installed to the replacement fluid pump; and a control device including: a control section that controls opening and closing of the replacement fluid clamp and operation of the replacement fluid pump; and a determination section that determines the presence or absence of poor installation of the replacement fluid line to the replacement fluid clamp, a flow path of the replacement fluid line on an upstream side of the portion installed to the replacement fluid pump is open to the dialysate circuit, and in a state in which the replacement fluid clamp is in a closed state and an arbitrary portion of a flow path on a downstream side of the venous chamber is occluded, the determination section determines the presence or absence of the poor installation based on a change in the venous pressure caused by rotation of the replacement fluid pump.

10. The method of detecting poor installation of a replacement fluid line of a hemodialysis device according to claim 9, wherein the arbitrary portion of the flow path on the downstream side of the venous chamber is a portion of the venous side line on the downstream side of the venous chamber or an arbitrary portion of a drain line connected to the venous side line.

11. The method of detecting poor installation of a replacement fluid line of a hemodialysis device according to claim 9 or 10, wherein in order to determine the presence or absence of the poor installation, the replacement fluid pump is rotated by X revolutions, and in a case where an absolute value of a difference obtained by subtracting a venous pressure P0 before the replacement fluid pump is rotated by X revolutions from a venous pressure Pl immediately after the replacement fluid pump is rotated by X revolutions is equal to or greater than a threshold value I set in advance in the determination section, the determination section determines that the poor installation is present, and in a case where the absolute value of the difference is less than the threshold value I, the determination section determines that the poor installation is not present.

12. The method of detecting poor installation of a replacement fluid line of a hemodialysis device according to claim 11, wherein the threshold value I is set to a value smaller than an absolute value of a difference obtained by subtracting a venous pressure p0 before the replacement fluid pump is rotated by X revolutions from a venous pressure pl immediately after the replacement fluid pump is rotated by X revolutions under the same conditions as those in which the determination of the presence or absence of the poor installation is performed except that the replacement fluid clamp installed to the replacement fluid line is set to an open state.

13. The method of detecting poor installation of a replacement fluid line of a hemodialysis device according to any one of claims 9 to 12, wherein a downstream end of the replacement fluid line is detachable with respect to the blood circuit at a position on an upstream side of the venous chamber in the blood circuit, The determination unit can also determine the connection state of the replacement fluid line to the blood circuit, After obtaining the determination result of no installation failure, in a state in which the replacement fluid clamp is operated by the control unit to be in an open state, the determination unit determines whether the connection state is appropriate based on the change in the venous pressure caused by the rotation of the replacement fluid pump.

14. The method according to claim 13, wherein the determination of the installation failure of the replacement fluid line of the hemodialysis apparatus is performed after the dialysate as the priming fluid is filled in the blood circuit and the replacement fluid line. rotating the replacement fluid pump by Y rotations in order to determine whether the connection state is appropriate, the venous pressure P immediately after the replacement fluid pump has been rotated by Y rotations 11 the venous pressure P before the replacement fluid pump was rotated by Y rotations 10 the absolute value of the difference thus obtained is equal to or greater than a threshold value II set in advance in the determination unit, the determination unit determines that the connection state is appropriate, and is less than the threshold value II, the determination unit determines that the connection state is inappropriate.

15. The method according to claim 14, wherein the determination of the installation failure of the replacement fluid line of the hemodialysis apparatus is performed after the dialysate as the priming fluid is filled in the blood circuit and the replacement fluid line. The threshold value II is set to a value smaller than the absolute value of the difference between the venous pressure p just after the substitution fluid pump is rotated by Y rotations under the same conditions as the judgment of whether the connection of the substitution fluid line to the blood circuit is appropriate, and the venous pressure p before the rotation by Y rotations 11 The absolute value of the difference between the venous pressure p just after the substitution fluid pump is rotated by Y rotations under the same conditions as the judgment of whether the connection of the substitution fluid line to the blood circuit is appropriate, and the venous pressure p before the rotation by Y rotations 10 is subtracted.

16. The method according to any one of claims 9 to 15, wherein the determination of the installation failure is performed after the dialysate as the priming fluid is filled in the blood circuit and the replacement fluid line.

17. The method according to any one of claims 9 to 16, wherein the determination of the installation failure is performed after the dialysate as the priming fluid is filled in the blood circuit and the replacement fluid line.

Images