Blood purification device

Abstract

To confirm connection of each constitution of the whole passage of a replacement fluid pipe while suppressing a leakage of a dialysis fluid at a connection port on the passage of the replacement fluid pipe.SOLUTION: A control unit 1 performs: a first process of closing an artery side on-off valve 110v, a vein side on-off valve 116v, and a replacement fluid on-off valve 131v; a second process of bringing a replacement fluid pump 161 into operation; and a third process of determining whether an increase amount in an artery side measured value or a vein side measured value ranges from a first threshold v1 to a second threshold v2 within a fixed period from the time of the operation start of the replacement fluid pump 161.SELECTED DRAWING: Figure 3

Description

Technical Field

[0001] The present invention relates to a blood purification device.

Background Art

[0002] As a prior art document that discloses the configuration of a blood purification device, there is Japanese Patent No. 5442483 (Patent Document 1). The blood purification device described in Patent Document 1 includes a blood purifier, an arterial side blood circuit, a venous side blood circuit, a dialysate introduction line, a dialysate discharge line, a replenishing fluid line, and a replenishing fluid pump. One end of the replenishing fluid line is connected to a sampling port formed at a predetermined site of the dialysate introduction line, and the other end is connected to the arterial side blood circuit or the venous side blood circuit. The replenishing fluid pump is disposed in the replenishing fluid line and can supply the dialysate in the dialysate introduction line to the arterial side blood circuit or the venous side blood circuit. A closed circuit is formed in the flow path of the dialysate on the dialysate introduction line side including the predetermined site where the sampling port is formed, and a test process for confirming the connection of the replenishing fluid line to the sampling port is performed by measuring the hydraulic pressure in the closed circuit while driving the replenishing fluid pump with a measuring means.

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0004] In the blood purification device described in Patent Document 1, when the connection of the connection port on the fluid supply line located downstream of the fluid supply pump is checked by applying the fluid pressure of the dialysate to the connection port, if the connection of the fluid supply line to the connection port is insufficient, the dialysate will leak to the outside from the connection point. Furthermore, because the connection port and the fluid pressure measuring means are located on either the upstream or downstream side of the fluid supply pump, it is not possible to check the connections of each component in the fluid supply line on the side opposite to the side to which the connection port and measuring means are connected relative to the fluid supply pump, and therefore it is not possible to check the connections of each component of the entire fluid supply line.

[0005] The present invention has been made to solve the above problems and aims to provide a blood purification device that can suppress leakage of dialysate at the connection ports of the infusion line while allowing confirmation of the connections of each component of the entire infusion line. [Means for solving the problem]

[0006] The blood purification device according to the present invention comprises a blood purifier, an arterial blood circuit, a venous blood circuit, a dialysate line, a drain line, a replacement fluid supply line, a replacement fluid introduction line, a blood pump, an arterial air trap chamber, an arterial on / off valve, a venous air trap chamber, a venous on / off valve, a priming fluid line, a replacement fluid pump, a dialysate pump, a drain pump, a replacement fluid on / off valve, an arterial pressure measuring device, a venous pressure measuring device, and a control unit. The arterial blood circuit is connected to the blood purifier and is provided to allow blood to flow into the blood purifier. The venous blood circuit is connected to the blood purifier and is provided to allow blood to flow out of the blood purifier. The dialysate line supplies dialysate to the blood purifier. The drain line carries the drainage fluid discharged from the blood purifier. The replacement fluid supply line is connected to either the arterial or venous blood circuit and supplies replacement fluid. The fluid inlet line is connected to the dialysate line and has a connection port on the second end opposite to the first end connected to the dialysate line, which can be connected to the fluid supply line. The blood pump is located in the arterial blood circuit and pumps blood. The arterial air trap chamber is located in the arterial blood circuit. The arterial on / off valve is located in the arterial blood circuit and opens and closes the arterial blood circuit. The venous air trap chamber is located in the venous blood circuit. The venous on / off valve is located in the venous blood circuit and opens and closes the venous blood circuit. The priming fluid line is connected to the arterial blood circuit between the arterial on / off valve and the blood pump and supplies priming fluid. The fluid inlet pump is located in the fluid supply line and pumps fluid. The dialysate pump is located in the dialysate line and pumps dialysate. The drain pump is located in the drain line and pumps drainage. The fluid inlet valve is located in the fluid inlet line and opens and closes the fluid inlet line. The arterial pressure measuring device measures the pressure inside the arterial air trap chamber. The venous pressure measuring device measures the pressure inside the venous air trap chamber. The control unit receives the arterial pressure measurement from the arterial pressure measuring device or the venous pressure measurement from the venous pressure measuring device.The control unit performs a first step of closing the arterial valve, the venous valve, and the fluid replacement valve, a second step of operating the fluid replacement pump, and a third step of determining whether the increase in the arterial or venous measurement value is within a range of 1 to 2 thresholds within a certain time from the start of operation of the fluid replacement pump.

[0007] In one embodiment of the present invention, the control unit performs a first step before priming, in which priming fluid is supplied from the priming fluid pipeline to the arterial blood circuit, blood purifier, and venous blood circuit. In the third step, if the increase in the arterial or venous measurement value is within the range of a first threshold or more and a second threshold or less, the control unit performs a fourth step to initiate priming.

[0008] In one embodiment of the present invention, the fluid supply pipeline is connected to the arterial blood circuit. Arterial measurement values ​​are input to the control unit. In the third step, the control unit determines whether the increase in arterial measurement values ​​is within a range of a first threshold and above and a second threshold and below within a certain time from the start of operation of the fluid pump.

[0009] In one embodiment of the present invention, the fluid supply pipeline is connected to the venous blood circuit. The control unit receives the venous measurement values. In the third step, the control unit determines whether the increase in the venous measurement values ​​is within a range of a first threshold and above and below a second threshold within a certain time from the start of operation of the fluid pump.

[0010] In one embodiment of the present invention, the first threshold is 2 kPa or more and 3 kPa or less. The second threshold is 10 kPa or more and 11 kPa or less. [Effects of the Invention]

[0011] According to the present invention, it is possible to confirm the connections of each component of the entire fluid replacement line while suppressing leakage of dialysate at the connection ports of the fluid replacement line. [Brief explanation of the drawing]

[0012] [Figure 1]This is a circuit diagram showing the configuration of a blood purification device according to Embodiment 1 of the present invention. [Figure 2] This is a block diagram showing the electrical connection relationships between the control unit and each component in a blood purification device according to Embodiment 1 of the present invention. [Figure 3] This flowchart shows the operation for checking the connection status of each component in the fluid replacement line of a blood purification device according to Embodiment 1 of the present invention. [Figure 4] This graph shows the relationship between the pressure of the arterial pressure measuring device and the operation of the fluid replacement pump in a blood purification device according to Embodiment 1 of the present invention. [Figure 5] This is a circuit diagram showing the configuration of a blood purification device according to Embodiment 2 of the present invention. [Figure 6] This flowchart shows the operation for checking the connection status of each component in the fluid replacement line of a blood purification device according to Embodiment 2 of the present invention. [Modes for carrying out the invention]

[0013] Hereinafter, blood purification devices according to each embodiment of the present invention will be described with reference to the drawings. In the following description of the embodiments, the same or corresponding parts in the figures will be denoted by the same reference numerals, and their descriptions will not be repeated.

[0014] In the following description of embodiments, the blood purification device described will be a blood purification device used in continuous renal replacement therapy (CRRT). However, the blood purification device may also be a blood purification device used in continuous hemodiafiltration (CHDF), continuous hemofiltration (CHF), or continuous hemodialysis (CHD).

[0015] (Embodiment 1) Figure 1 is a circuit diagram showing the configuration of a blood purification device according to Embodiment 1 of the present invention. As shown in Figure 1, the blood purification device 100 according to Embodiment 1 of the present invention comprises a blood purifier 120, an arterial blood circuit 110, a venous blood circuit 116, a dialysate line 141, a drainage line 151, a fluid replacement line, a blood pump 111, an arterial air trap chamber 112, an arterial on / off valve 110v, a venous air trap chamber 114, a venous on / off valve 116v, a priming fluid line 191, a fluid replacement pump 161, a dialysate pump 160, a drainage pump 162, a fluid replacement valve 131v, an arterial pressure measuring device 113, a venous pressure measuring device 115, and a control unit.

[0016] The blood purification device 100 further comprises a first supply source 130, a priming fluid supply source 190, an arterial supply and exhaust line 117, a venous supply and exhaust line 118, a first valve 141v, a second valve 151v, a third valve 191v, a fourth valve 117v, a fifth valve 118v, an arterial protective filter 117f, a venous protective filter 118f, a first heater 170, and a second heater 171.

[0017] The blood purifier 120 contains a semipermeable membrane, for example, made of a hollow fiber membrane. The blood purifier 120 has a blood inlet 121 and a blood outlet 122. The arterial blood circuit 110 is connected to the blood inlet 121. The venous blood circuit 116 is connected to the blood outlet 122.

[0018] The arterial blood circuit 110 is equipped with a blood pump 111 for pumping blood. In the arterial blood circuit 110, an arterial air trap chamber 112 is provided between the blood pump 111 and the blood purifier 120. The arterial air trap chamber 112 is equipped with an arterial pressure measuring device 113 for measuring the pressure inside the arterial air trap chamber 112. An arterial protective filter 117f is provided between the arterial air trap chamber 112 and the arterial pressure measuring device 113. The arterial blood circuit 110 is equipped with an arterial on / off valve 110v for opening and closing the arterial blood circuit 110.

[0019] The blood collected from the patient's artery flows through the arterial blood circuit 110 and is measured for pressure when passing through the arterial air trap chamber 112, and then flows into the blood purifier 120 from the blood inlet 121. The arterial air trap chamber 112 is provided to prevent air from mixing into the blood in the arterial blood circuit 110.

[0020] The venous blood circuit 116 is provided with a venous air trap chamber 114. The venous air trap chamber 114 is provided with a venous pressure measuring device 115 for measuring the pressure in the venous air trap chamber 114. A venous protection filter 118f is provided between the venous air trap chamber 114 and the venous pressure measuring device 115. The venous blood circuit 116 is provided with a venous opening and closing valve 116v for opening and closing the venous blood circuit 116.

[0021] The blood purified by the blood purifier 120 flows through the venous blood circuit 116 and is measured for pressure when passing through the venous air trap chamber 114, and then is returned to the patient's vein. The venous air trap chamber 114 is provided to prevent air from mixing into the blood in the venous blood circuit 116.

[0022] The blood purifier 120 further has a dialysate inlet 124 and a drainage outlet 123. A dialysate pipeline 141 is connected to the dialysate inlet 124. A drainage pipeline 151 is connected to the drainage outlet 123.

[0023] The upstream end of the dialysate pipeline 141 is connected to a first supply source 130 that supplies the first fluid 10, which is the replacement fluid and dialysate. A dialysate pump 160 is connected to the dialysate pipeline 141 to deliver the dialysate. The dialysate pump 160 is a peristaltic pump, but may also be a roller pump. The dialysate that flows through the dialysate pipeline 141 is supplied into the blood purifier 120. A first valve 141v for opening and closing the dialysate pipeline 141 is provided downstream of the connection point with the replacement fluid introduction pipeline 131, which will be described later. A first heater 170 for heating the dialysate is provided downstream of the dialysate pump 160 in the dialysate pipeline 141. The first heater 170 is not required.

[0024] The fluid replacement line supplies fluid to the blood circuit. In this embodiment, the fluid replacement line includes a fluid introduction line 131 and a fluid supply line 132.

[0025] The fluid infusion line 131 is connected to the dialysate line 141 at its first end 133. The fluid infusion line 131 has a connection port 135 at its second end 134, opposite to the first end 133, which can be connected to the fluid supply line 132. The fluid infusion line 131 is equipped with a fluid infusion on / off valve 131v for opening and closing the fluid infusion line 131.

[0026] The fluid supply line 132 is connected to the fluid inlet line 131 at the connection port 135. A fluid pump 161 is connected to the fluid supply line 132 to deliver the fluid. The fluid pump 161 is a peristaltic pump, but it may also be a roller pump. A second heater 171 for heating the fluid is provided downstream of the fluid pump 161 in the fluid inlet line 131. However, the second heater 171 is not required.

[0027] In this embodiment, the fluid supply line 132 is connected to the arterial blood circuit 110. Specifically, the fluid supply line 132 is connected to the arterial air trap chamber 112. The fluid that flows through the fluid supply line 132 is supplied into the arterial air trap chamber 112. In other words, the fluid supply line 132 supplies fluid to the arterial blood circuit 110. The blood purification device 100 employs a so-called pre-dilution method.

[0028] Drainage fluid discharged from the blood purifier 120 is discharged from the downstream end of the drainage pipe 151. A drainage pump 162 is connected to the drainage pipe 151 to send out the drainage fluid flowing through the drainage pipe 151. The drainage pump 162 is a peristaltic pump, but it may also be a roller pump. A second valve 151v is provided in the drainage pipe 151 to open and close the drainage pipe 151.

[0029] The priming fluid line 191 is connected between the arterial-side on / off valve 110v and the blood pump 111 in the arterial-side blood circuit 110, and supplies the priming fluid 20. The priming fluid line 191 is equipped with a third valve 191v that opens and closes the priming fluid line 191. The priming fluid 20 is physiological saline solution or the like.

[0030] The arterial side supply and exhaust conduit 117 is connected between the arterial side pressure measuring device 113 and the arterial side protective filter 117f. The arterial side supply and exhaust conduit 117 is provided with a fourth valve 117v for opening and closing the arterial side supply and exhaust conduit 117. The arterial side supply and exhaust conduit 117 is configured to exhaust air from the arterial side air trap chamber 112 and to supply air into the arterial side air trap chamber 112.

[0031] The venous supply and exhaust line 118 is connected between the venous pressure measuring device 115 and the venous protective filter 118f. The venous supply and exhaust line 118 is provided with a fifth valve 118v for opening and closing the venous supply and exhaust line 118. The venous supply and exhaust line 118 is configured to exhaust air from the venous air trap chamber 114 and to supply air into the venous air trap chamber 114.

[0032] Each of the arterial-side protective filter 117f and the venous-side protective filter 118f has the function of preventing blood from flowing out of the blood circuit and the function of preventing infection from the pressure measuring device.

[0033] Figure 2 is a block diagram illustrating the electrical connection relationships between the control unit and each component in a blood purification device according to Embodiment 1 of the present invention. As shown in Figure 2, the control unit 1 of the blood purification device 100 is electrically connected to the blood pump 111, arterial valve 110v, venous valve 116v, fluid replacement valve 131v, first valve 141v, second valve 151v, third valve 191v, fourth valve 117v, fifth valve 118v, arterial pressure measuring device 113, venous pressure measuring device 115, dialysate pump 160, fluid replacement pump 161, and drainage pump 162.

[0034] The control unit 1 receives either the arterial pressure measurement value measured by the arterial pressure measuring device 113 or the venous pressure measurement value measured by the venous pressure measuring device 115. In this embodiment, the control unit 1 receives the arterial pressure measurement value, which is the pressure inside the arterial air trap chamber 112 measured by the arterial pressure measuring device 113.

[0035] The control unit 1 controls the operation of each of the following: the blood pump 111, the arterial valve 110v, the venous valve 116v, the fluid replacement valve 131v, the first valve 141v, the second valve 151v, the third valve 191v, the fourth valve 117v, the fifth valve 118v, the dialysate pump 160, the fluid replacement pump 161, and the drainage pump 162.

[0036] Furthermore, the blood purification device 100 according to this embodiment may be provided with a measuring bag (not shown) that can temporarily store the first liquid 10 or drainage fluid and discharge the stored first liquid 10 or drainage fluid. If a measuring bag is provided, a scale such as a load cell may also be provided. With these configurations, the amount of dialysate discharged or sent out in the blood purification device 100 can be measured.

[0037] The following describes the operation for checking the connection status of the fluid introduction line 131 and the fluid supply line 132 before priming in the blood purification device 100 according to this embodiment.

[0038] Figure 3 is a flowchart showing the operation for checking the connection status of each component in the fluid replacement line of the blood purification device according to Embodiment 1 of the present invention. Figure 4 is a graph showing the relationship between the pressure of the arterial pressure measuring device and the operation of the fluid replacement pump in the blood purification device according to Embodiment 1 of the present invention. In Figure 4, the left vertical axis shows pressure (kPa), the right vertical axis shows the operation of the fluid replacement pump, and the horizontal axis shows time (t). In the horizontal axis of Figure 4, time t1 shows the start time of the fluid replacement pump, and time t2 shows the stop time of the fluid replacement pump.

[0039] Generally, when priming a blood purification device, it is necessary to connect each component of the blood circuit. After connecting each component of the blood circuit, it is checked whether each component is correctly connected. In the blood purification device 100 of this embodiment, in order to perform fluid replacement, in addition to connecting each component of the blood circuit, it is also necessary to connect each component of the fluid replacement line. In this case, there is a possibility that the connections of each component of the fluid replacement line may be insufficient due to human error.

[0040] As shown in Figures 1, 3, and 4, the control unit 1 performs a first step (S1) in which it closes the arterial on / off valve 110v, the venous on / off valve 116v, and the fluid replacement on / off valve 131v before priming, in which the priming fluid 20 is supplied from the priming fluid pipeline 191 to the arterial blood circuit 110, the blood purifier 120, and the venous blood circuit 116.

[0041] Specifically, by closing the arterial valve 110v, the venous valve 116v, the fluid replacement valve 131v, the first valve 141v, the second valve 151v, the third valve 191v, the fourth valve 117v, and the fifth valve 118v, a closed circuit is formed in the arterial blood circuit 110, the blood purifier 120, the venous blood circuit 116, the fluid replacement inlet 131, and the fluid replacement supply 132. Since this is before priming, the priming fluid 20 is not present inside the closed circuit.

[0042] Next, the second step (S2) is performed, in which the fluid replenishment pump 161 is activated. By activating the fluid replenishment pump 161, the air in the fluid replenishment supply line 132 is compressed, and the pressure in the fluid replenishment supply line 132 increases.

[0043] Next, a third step (S3) is performed to determine whether the increase in the arterial or venous measurement value is within the range of a first threshold v1 or greater and a second threshold v2 or less within a certain time period from the start of operation of the infusion pump 161 (t1). In this embodiment, it is determined whether the increase in the arterial measurement value is within the range of a first threshold v1 or greater and a second threshold v2 or less within a certain time period from the start of operation of the infusion pump 161 (t1).

[0044] Specifically, as shown by the solid line in Figure 4, when the infusion pump 161 starts operating (t1), the pressure in the infusion supply pipeline 132 increases, causing the arterial pressure measurement to rise in the arterial pressure measuring device 113 to which the infusion supply pipeline 132 is connected. During the time from time t1 to time t2, it is confirmed that the increase in the arterial pressure measurement is greater than or equal to the first threshold v1. This confirms the connection between the infusion pump 161 and the infusion supply pipeline 132. The first threshold v1 is, for example, 2 kPa or more and 3 kPa or less.

[0045] If the fluid supply pipeline 132 is blocked midway, or if air is leaking to the outside due to a poor connection between the fluid pump 161 and the fluid supply pipeline 132, then the pressure increase in the fluid supply pipeline 132 downstream of the blockage or poor connection will not occur, and the increase in the arterial measurement will be less than or equal to the first threshold v1.

[0046] Furthermore, it is confirmed that the increase in arterial pressure measurements from time t1 to time t2 is less than or equal to the second threshold v2. This confirms the connection between the connection port 135 and the fluid supply pipeline 132. If the connection between the connection port 135 and the fluid supply pipeline 132 is good, the fluid inlet pipeline 131 and the fluid supply pipeline 132 upstream of the fluid pump 161 are closed circuits, preventing outside air from being drawn into the pipelines. Therefore, after the air in the pipelines is compressed by the fluid pump 161, no pressure increase occurs in the pipelines. As a result, the increase in arterial pressure measurements is maintained within the range of the first threshold v1 to the second threshold v2. The second threshold is, for example, 10 kPa to 11 kPa.

[0047] If the connection between the connection port 135 and the fluid supply pipeline 132 is faulty, the fluid supply pump 161 will continuously draw outside air into the pipeline from the connection point between the connection port 135 and the fluid supply pipeline 132, causing the arterial measurement to rise above the second threshold v2, as shown by the dotted line in Figure 4. The time required to confirm that the reading is within the range of the first threshold v1 and the second threshold v2 is, for example, 20 seconds. However, this time is not limited to 20 seconds. Furthermore, the first threshold v1 and the second threshold v2 are not limited to the pressure range described above and can be set as appropriate.

[0048] Next, in the third step (S3), if the increase in the arterial or venous measurement value is within the range of a first threshold v1 or more and a second threshold v2 or less, the fourth step (S4) is performed to initiate priming. In this embodiment, the control unit 1 initiates priming in the third step (S3) if the increase in the arterial measurement value is within the range of a first threshold v1 or more and a second threshold v2 or less.

[0049] In the third step (S3), if the value is outside the range of the first threshold v1 or greater and the second threshold v2 or less, the control unit 1 performs the fifth step (S5) to notify that there is a connection problem in the fluid replacement line. After the control unit 1 makes this notification, the fluid replacement line is reconnected, and the above steps are performed again to confirm that the fluid replacement line is properly connected.

[0050] In the blood purification device 100 according to Embodiment 1 of the present invention, the connection port 135, the fluid replacement pump 161, and the arterial pressure measuring device 113 are arranged in this order from upstream to downstream of the flow path through which pressure is applied to confirm the connection of the connection port 135. This allows the connection between the fluid replacement pump 161 and the fluid replacement supply line 132 to be confirmed by a first threshold v1, and the connection between the connection port 135 and the fluid replacement supply line 132 to be confirmed by a second threshold v2, thereby allowing the connection of each component of the entire fluid replacement line to be confirmed.

[0051] In the blood purification device 100 according to Embodiment 1 of the present invention, before priming, the connection status of the fluid replacement lines can be checked by the arterial pressure measuring device 113 in the arterial blood circuit 110 while there is no dialysate in the closed circuit formed by the fluid replacement line introduction line 131, fluid replacement line supply line 132, arterial blood circuit 110, and venous blood circuit 116. Therefore, if the connection status of each component of the fluid replacement lines is insufficient, leakage of dialysate from the connection point to the outside can be suppressed.

[0052] In the blood purification device 100 according to Embodiment 1 of the present invention, by confirming that the increase in the arterial pressure measurement value in the arterial pressure measuring device 113 is equal to or greater than the first threshold v1, it is possible to confirm the pressure rise in the fluid supply pipeline 132 due to the operation of the fluid supply pump 161, thereby confirming blockage on the fluid supply pipeline 132 or the connection status between the fluid supply pump 161 and the fluid supply pipeline 132.

[0053] In the blood purification device 100 according to Embodiment 1 of the present invention, by confirming that the increase in the arterial pressure measurement value in the arterial pressure measuring device 113 is less than or equal to the second threshold v2, it is possible to confirm that no air is being drawn into the fluid replacement line upstream of the fluid replacement pump 161 from the outside, and thus the connection status between the fluid replacement introduction line 131 and the fluid replacement supply line 132 at the connection port 135 can be confirmed.

[0054] The following describes a modified blood purification device according to Embodiment 1 of the present invention. Since the blood purification device according to this modified example differs from the blood purification device 100 according to Embodiment 1 of the present invention in that the medium used for pressure measurement to confirm the connection of the connection ports is different; therefore, the same configuration as the blood purification device 100 according to Embodiment 1 of the present invention will not be repeated in this description.

[0055] In this modified example, when checking the connection status of the fluid inlet pipeline 131 and the fluid supply pipeline 132, the fluid inlet pipeline 131 and the fluid supply pipeline 132 are filled with dialysate.

[0056] When the infusion pump 161 is operated, if the connection of the connection port 135 is insufficient, external air is drawn from the connection port 135 into the infusion supply line 132, so the dialysate does not leak from the connection port 135. In this modified example, the blood purification device returns to normal operation when the connection of each component of the infusion line is confirmed in step S3 shown in Embodiment 1.

[0057] In a blood purification device according to a modified embodiment of the present invention, even if the connection of the connection port 135 is insufficient when the closed circuit formed by the replacement fluid introduction line 131, the replacement fluid supply line 132, the arterial blood circuit 110, and the venous blood circuit 116 is filled with dialysate, the operation of the replacement fluid pump 161 draws outside air from the connection port 135 into the replacement fluid supply line 132, thereby suppressing leakage of dialysate from the connection port 135 of the replacement fluid line.

[0058] In the blood purification device according to a modified embodiment of Embodiment 1 of the present invention, similar to Embodiment 1, the connection port 135, the fluid replacement pump 161, and the arterial pressure measuring device 113 are arranged in this order from upstream to downstream of the flow path through which pressure is applied to confirm the connection of the connection port 135. This allows the connection between the fluid replacement pump 161 and the fluid replacement supply line 132 to be confirmed by a first threshold v1, and the connection between the connection port 135 and the fluid replacement supply line 132 to be confirmed by a second threshold v2, thereby allowing the connection of each component of the entire fluid replacement line to be confirmed.

[0059] (Embodiment 2) The blood purification device according to Embodiment 2 of the present invention will now be described. The blood purification device according to Embodiment 2 of the present invention differs from the blood purification device 100 according to Embodiment 1 of the present invention mainly in that the fluid replacement line is connected to the venous blood circuit. Therefore, the same configuration as the blood purification device 100 according to Embodiment 1 of the present invention will not be repeated in the description.

[0060] Figure 5 is a circuit diagram showing the configuration of a blood purification device according to Embodiment 2 of the present invention. As shown in Figure 5, the fluid replacement pipeline of the blood purification device 200 according to Embodiment 2 of the present invention includes a fluid replacement introduction pipeline 231 and a fluid replacement supply pipeline 232.

[0061] The fluid inlet line 231 is connected to the dialysate line 141 at its first end 233. The fluid inlet line 231 has a connection port 235 at its second end 234, opposite to the first end 233, which can be connected to the fluid supply line 232. The fluid inlet line 231 is equipped with a fluid on / off valve 231v for opening and closing the fluid inlet line 231. The fluid supply line 232 is connected to the fluid inlet line 231 at its connection port 235.

[0062] In this embodiment, the fluid supply line 232 is connected to the venous blood circuit 116. Specifically, the fluid supply line 232 is connected to the venous air trap chamber 114. The fluid that flows through the fluid supply line 232 is supplied into the venous air trap chamber 114. In other words, the fluid supply line 232 supplies fluid to the venous blood circuit 116. The blood purification device 200 employs a so-called post-dilution method. The control unit 1 receives the venous pressure measurement value, which is the pressure inside the venous air trap chamber 114 measured by the venous pressure measuring device 115.

[0063] The following describes the operation for checking the connection status of the fluid infusion line 231 and the fluid supply line 232 before priming in the blood purification device 200 according to this embodiment. Figure 6 is a flowchart showing the operation for checking the connection status of each component in the fluid infusion line of the blood purification device according to Embodiment 2 of the present invention.

[0064] As shown in Figure 6, the control unit 1 performs a first step (S1) in which it closes the arterial on / off valve 110v, the venous on / off valve 116v, and the fluid replacement on / off valve 231v before priming, in which the priming fluid 20 is supplied from the priming fluid pipeline 191 to the arterial blood circuit 110, the blood purifier 120, and the venous blood circuit 116.

[0065] Specifically, by closing the arterial valve 110v, the venous valve 116v, the fluid replacement valve 231v, the first valve 141v, the second valve 151v, the third valve 191v, the fourth valve 117v, and the fifth valve 118v, a closed circuit is formed in the arterial blood circuit 110, the blood purifier 120, the venous blood circuit 116, the fluid replacement inlet 231, and the fluid replacement supply 232. Since this is before priming, the priming fluid 20 is not present inside the closed circuit.

[0066] Next, the second step (S2) is performed, in which the fluid replenishment pump 161 is activated. Specifically, by activating the fluid replenishment pump 161, the air in the fluid replenishment supply line 232 is compressed, causing the pressure in the fluid replenishment supply line 232 to increase.

[0067] Next, a third step (S3) is performed to determine whether the increase in the venous measurement value is within the range of a first threshold or more and a second threshold or less within a certain time period from the start of operation of the infusion pump 161.

[0068] Specifically, the operation of the fluid replacement pump 161 increases the pressure in the fluid replacement line 232, causing the venous pressure measurement to rise in the venous pressure measuring device 115 to which the fluid replacement line 232 is connected. It is confirmed that the increase in the venous pressure measurement within a certain period of time is equal to or greater than a first threshold. This confirms the connection between the fluid replacement pump 161 and the fluid replacement line 232. The first threshold is, for example, 2 kPa or more and 3 kPa or less.

[0069] Furthermore, it is confirmed that the increase in the venous measurement value is below the second threshold within a certain time period from time t1. This confirms the connection between the connection port 235 and the fluid supply line 232. If the connection between the connection port 235 and the fluid supply line 232 is good, the fluid inlet line 231 and the fluid supply line 232 upstream of the fluid pump 161 are closed circuits, so no outside air is drawn into the lines. Therefore, after the air in the lines is compressed by the fluid pump 161, no pressure increase occurs in the lines. For this reason, the increase in the venous measurement value is maintained within the range of the first threshold to the second threshold. The second threshold is, for example, 10 kPa to 11 kPa.

[0070] Next, in step 3 (S3), if the increase in the venous measurement is within the range of the first threshold or higher and the second threshold or lower, step 4 (S4) is performed to initiate priming.

[0071] In the third step (S3), if the value is outside the range of the first threshold and above and below the second threshold, the control unit performs the fifth step (S5) to notify that there is a connection problem in the fluid replacement line. After the control unit makes this notification, the fluid replacement line is reconnected, and the above steps are performed again to confirm that the fluid replacement line is properly connected.

[0072] In the blood purification device 200 according to Embodiment 2 of the present invention, the connection port 235, the fluid replacement pump 161, and the venous pressure measuring device 115 are arranged in this order from upstream to downstream of the flow path through which pressure is applied to confirm the connection of the connection port 235. This allows the connection between the fluid replacement pump 161 and the fluid replacement supply line 232 to be confirmed by a first threshold, and the connection between the connection port 235 and the fluid replacement supply line 232 to be confirmed by a second threshold, thereby allowing the connection of each component of the entire fluid replacement line to be confirmed.

[0073] In the blood purification device 200 according to Embodiment 2 of the present invention, before priming, the connection status of the fluid replacement lines can be checked by the venous pressure measuring device 115 in the venous blood circuit 116 while there is no dialysate in the closed circuit formed by the fluid replacement introduction line 231, the fluid replacement supply line 232, the arterial blood circuit 110, and the venous blood circuit 116. Therefore, if the connection status of each component of the fluid replacement lines is insufficient, leakage of dialysate from the connection point to the outside can be suppressed.

[0074] The following describes a modified blood purification device according to Embodiment 2 of the present invention. Since the medium used for pressure measurement to confirm the connection of the connection ports differs between this modified blood purification device and the blood purification device 200 according to Embodiment 2 of the present invention, the same configurations as those in the blood purification device 200 according to Embodiment 2 of the present invention will not be repeated.

[0075] In this modified example, when checking the connection status of the fluid inlet pipeline 231 and the fluid supply pipeline 232, the fluid inlet pipeline 231 and the fluid supply pipeline 232 are filled with dialysate.

[0076] Even when the infusion introduction line 231 and the infusion supply line 232 are filled with dialysate, when the infusion pump 161 is operated, if the connection of the connection port 235 is insufficient, outside air is drawn from the connection port 235 into the infusion supply line 232, so dialysate does not leak from the connection port 235. In this modified example, the blood purification device returns to normal operation when the connection of each component of the infusion line is confirmed in step S3 shown in Embodiment 1.

[0077] In the blood purification device according to a modified embodiment of the present invention, even if the connection of the connection port 235 is insufficient when the closed circuit formed by the replacement fluid introduction line 231, the replacement fluid supply line 232, the arterial blood circuit 110, and the venous blood circuit 116 is filled with dialysate, the operation of the replacement fluid pump 161 draws outside air from the connection port 235 into the replacement fluid supply line 232, thereby suppressing leakage of dialysate from the connection port 235 of the replacement fluid line.

[0078] In the blood purification device according to a modified embodiment of the present invention, similar to embodiment 2, the connection port 235, the fluid replacement pump 161, and the arterial pressure measuring device 113 are arranged in this order from upstream to downstream of the flow path through which pressure is applied to confirm the connection of the connection port 235. This allows the connection between the fluid replacement pump 161 and the fluid replacement supply line 232 to be confirmed by a first threshold v1, and the connection between the connection port 235 and the fluid replacement supply line 232 to be confirmed by a second threshold v2, thereby allowing the connection of each component of the entire fluid replacement line to be confirmed.

[0079] The embodiments disclosed herein are illustrative in all respects and are not intended to be restrictive. Therefore, the technical scope of this disclosure is not limited to the embodiments described above. Furthermore, all modifications within the meaning and scope of equivalence to the claims are included. In the description of the embodiments above, combinatable configurations may be combined with each other. [Explanation of symbols]

[0080] 1 Control unit, 10 First fluid, 20 Priming fluid, 100, 200 Blood purification device, 110 Arterial blood circuit, 110v Arterial on / off valve, 111 Blood pump, 112 Arterial air trap chamber, 113 Arterial pressure measuring device, 114 Venous air trap chamber, 115 Venous pressure measuring device, 116 Venous blood circuit, 116v Venous on / off valve, 117 Arterial supply / exhaust line, 117f Arterial protective filter, 117v Fourth valve, 118 Venous supply / exhaust line, 118f Venous protective filter, 118v Fifth valve, 120 Blood purifier, 121 Blood inlet, 122 Blood outlet, 123 Drain outlet, 124 Dialysis fluid inlet, 130 First supply source, 131, 231 Infusion introduction line, 131v, 231v Infusion valve, 132,232 Infusion supply line, 133,233 First end, 134,234 Second end, 135,235 Connection port, 141 Dialysis fluid line, 141v First valve, 151 Drain line, 151v Second valve, 160 Dialysis fluid pump, 161 Infusion pump, 162 Drain pump, 170 First heater, 171 Second heater, 190 Priming fluid supply source, 191 Priming fluid line, 191v Third valve, v1 First threshold, v2 Second threshold.

Claims

1. A blood purifier, An arterial blood circuit connected to the blood purifier for supplying blood to the blood purifier, A venous blood circuit connected to the blood purifier for draining blood from the blood purifier, A dialysate pipeline for supplying dialysate to the aforementioned blood purifier, A drainage pipe for carrying the drained fluid discharged from the blood purifier, A fluid supply conduit connected to the arterial blood circuit or the venous blood circuit for supplying fluid replacement, A replacement fluid introduction line is connected to the dialysate line and has a connection port at a second end opposite to the first end connected to the dialysate line that can be connected to the replacement fluid supply line, A blood pump is provided in the arterial blood circuit to pump blood, The arterial side air trap chamber provided in the arterial side blood circuit, An arterial side on / off valve is provided in the arterial side blood circuit and opens and closes the arterial side blood circuit, A venous air trap chamber provided in the venous blood circuit, A venous on / off valve is provided in the venous blood circuit and opens and closes the venous blood circuit, A priming fluid conduit is connected to the arterial blood circuit between the arterial side on / off valve and the blood pump, and supplies priming fluid. A fluid supply pump is provided in the aforementioned fluid supply pipeline to deliver the fluid, A dialysate pump is provided in the dialysate pipeline for delivering dialysate, A drainage pump is provided in the aforementioned drainage pipeline to send out the drainage liquid, A fluid supply valve is provided in the fluid supply introduction pipeline and opens and closes the fluid supply introduction pipeline, An arterial pressure measuring device for measuring the pressure inside the arterial air trap chamber, A venous pressure measuring device for measuring the pressure inside the venous air trap chamber, The system comprises a control unit that receives the arterial pressure measurement value measured by the arterial pressure measuring device or the venous pressure measurement value measured by the venous pressure measuring device, The control unit, The first step is to close the arterial valve, the venous valve, and the fluid replacement valve. The second step involves operating the aforementioned fluid replenishment pump. A blood purification device that performs a third step of determining whether the increase in the arterial measurement value or the venous measurement value is within a range of a first threshold or more and a second threshold or less within a certain time period from the start of operation of the fluid replacement pump.

2. The control unit, Before priming, the first step is performed, in which the priming fluid is supplied from the priming fluid conduit to the arterial blood circuit, the blood purifier, and the venous blood circuit. The blood purification apparatus according to claim 1, wherein in the third step, if the increase in the arterial measurement value or the venous measurement value is within the range of a first threshold or more and a second threshold or less, a fourth step of initiating priming is performed.

3. The fluid supply pipeline is connected to the arterial blood circuit, The control unit receives the arterial measurement value, The blood purification apparatus according to claim 1 or 2, wherein the control unit determines in the third step whether the increase in the arterial measurement value is within the range of a first threshold or more and a second threshold or less within a certain time period from the start of operation of the fluid replacement pump.

4. The fluid supply pipeline is connected to the venous blood circuit, The control unit receives the venous measurement value as input. The blood purification apparatus according to claim 1 or 2, wherein the control unit determines in the third step whether the increase in the venous measurement value is within the range of a first threshold or more and a second threshold or less within a certain time period from the start of operation of the fluid replacement pump.

5. The first threshold is 2 kPa or more and 3 kPa or less. The blood purification device according to claim 2, wherein the second threshold is 10 kPa or more and 11 kPa or less.

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