Blood purification device

Abstract

When performing drainage in an AV connection type blood circuit, it is determined that the blood circuit is in an AV connection state. A blood purification device includes a blood circuit having a blood withdrawal side circuit and a blood return side circuit, one end of the blood withdrawal side circuit and one end of the blood return side circuit being connected to each other by a blood purifier, and the other end of the blood withdrawal side circuit and the other end of the blood return side circuit being connected to each other, whereby a closed circuit can be formed; a blood pump provided in the blood circuit; a flow path switching section capable of being switched between an open state in which a fluid can flow through one end of the blood withdrawal side circuit and one end of the blood return side circuit, and a closed state in which the fluid cannot flow; a pressure detection section for detecting an internal pressure of the blood circuit; and a control section that, when the blood circuit is in a state in which the closed circuit is formed, performs a drainage process of draining residual liquid in the blood circuit to a predetermined discharge location. The control section performs the following control: in the closed state, after a pressure difference is generated between the blood withdrawal side circuit and the blood return side circuit by rotation of the blood pump, the open state is switched to, and the pressure difference is monitored based on a detection result of the pressure detection section to determine whether the blood circuit is the closed circuit.

Description

Technical Field

[0001] This invention relates to a blood purification device that performs self-diagnosis of the connection status of the blood circuit during the drainage process. Background Technology

[0002] Blood purification devices are used to treat patients. A blood purification device has a blood circuit for removing blood from the patient's body and returning it back into the body. The blood circuit mainly consists of a blood removal circuit (also called an arterial side circuit) that connects to the dialyzer and a blood return circuit (also called a venous side circuit). The dialyzer is known as a blood purification device.

[0003] After treating a patient, the puncture needle is sometimes removed from the patient's body, and the fluid in the blood circuit is drained and discarded. This is done to prevent medical staff from being splashed with fluid during subsequent procedures if any fluid remains in the blood circuit, and also to reduce disposal costs when discarding the blood circuit or dialyzer (Patent Document 1).

[0004] Existing technical documents

[0005] Patent Document 1: JP No. 4160754 Invention Patent Publication

[0006] Patent Document 2: JP No. 6437349 Invention Patent Publication Summary of the Invention

[0007] Patent Document 1 discloses a method for hygienically and safely draining fluid from a blood circuit by making the blood circuit a closed loop. However, Patent Document 1 does not mention a method for confirming the connection status of the blood circuit before initiating drainage. If drainage is performed without forming a proper closed loop, fluid leakage from the blood circuit may occur, and if the connection to the patient is maintained, unnecessary debledration may result. Thus, the problem of inadequate drainage arises.

[0008] The procedure for draining fluid in an AV-connected (closed-loop) blood circuit is performed when there is no puncture needle on the patient, and the blood loss circuit and return circuit are connected, i.e., in the AV-connected state. Patent Document 2 discloses a method in which, in a procedure prior to draining fluid from the blood circuit, if a needle may be connected to the patient, the blood pump is stopped and the operation is restricted to a low speed. However, Patent Document 2 does not mention the determination of the AV-connected state.

[0009] The purpose of this invention is to determine that the blood circuit is in an AV connection state when draining fluid from the blood circuit.

[0010] One embodiment of the blood purification device of the present invention includes: a blood circuit having: a blood removal side circuit into which blood from a patient is desorbed flows; a blood return side circuit into which blood is returned to the patient, wherein one end of the blood removal side circuit and one end of the blood return side circuit are interconnected by a blood purifier, and the other end of the blood removal side circuit and the other end of the blood return side circuit are directly or indirectly interconnected, thereby forming a closed loop; a blood pump disposed in the blood circuit; a flow path switching unit capable of switching between an open state in which fluid can flow through one end of the blood removal side circuit and one end of the blood return side circuit, and a closed state in which fluid cannot flow through one end of the blood removal side circuit and one end of the blood return side circuit; a pressure detection unit for detecting the internal pressure of the blood circuit; and a control unit that, when the blood circuit is in the state of forming the closed loop, performs a drainage process, wherein the drainage process is to drain residual fluid in the blood circuit to a predetermined discharge point. The control unit performs the following control: It further executes a judgment process, in which, when the flow path switching unit is switched to the closed state, after a pressure difference is generated between the blood loss side circuit and the blood return side circuit due to the rotation of the blood pump, the flow path switching unit is switched to the open state, and the pressure difference is monitored based on the detection result of the pressure detection unit to determine whether the blood circuit is a closed circuit. If the judgment process determines that it is a closed circuit, the drainage process is executed after the judgment.

[0011] The blood purification device can self-diagnose that the blood circuit is in AV connection state when draining fluid from the AV-connected blood circuit. Attached Figure Description

[0012] A detailed understanding of the embodiments disclosed in this specification can be obtained from the following description, illustrated in conjunction with the accompanying drawings.

[0013] [ Figure 1 This is a piping diagram showing the configuration of the blood purification apparatus related to the first embodiment.

[0014] [ Figure 2 This diagram illustrates the self-diagnosis process, implemented in the case of drainage within the blood circuit connected to the first embodiment and initiating AV connection.

[0015] [ Figure 3 [This is a diagram showing the first state of the blood purification device related to the first embodiment.]

[0016] [ Figure 4 [This is a diagram showing the second state of the blood purification device related to the first embodiment.]

[0017] [ Figure 5 [This is a diagram showing the third state of the blood purification device related to the first embodiment.]

[0018] [ Figure 6 [This is a diagram showing the fourth state of the blood purification device related to the first embodiment.]

[0019] [ Figure 7 This diagram illustrates the drainage operation from the blood circuit in the AV connection state.

[0020] [ Figure 8 This is a diagram showing an overview of the A-pressure and V-pressure from the first state to the fourth state.

[0021] [ Figure 9 This diagram illustrates the self-diagnosis process, implemented in the context of draining fluid from the blood circuit connected to the AV connection, which is related to the second embodiment.

[0022] [ Figure 10 [This is a diagram showing the fifth state of the blood purification device related to the second embodiment.]

[0023] [ Figure 11 [This is a diagram showing the sixth state of the blood purification device related to the second embodiment.]

[0024] [ Figure 12 [This is a diagram showing the seventh state of the blood purification device related to the second embodiment.]

[0025] [ Figure 13 [This is a diagram showing the eighth state of the blood purification device related to the second embodiment.] Detailed Implementation

[0026] Hereinafter, with reference to the accompanying drawings, several embodiments of a blood purification apparatus will be described. The blood purification apparatus can be a device for dialysis treatment, but the spirit of the present invention can also be applied to devices other than dialysis treatment devices. The blood purification apparatus includes: a piping section for allowing dialysate to flow into the dialyzer; and an extracorporeal circulation section for allowing the patient's blood to flow into the dialyzer. In this specification, the spirit of the present invention will be described with reference to the configuration of the extracorporeal circulation section of the blood purification apparatus.

[0027] In this specification, the first letter of the English word for the corresponding artery is sometimes referred to as "A," and the first letter of the English word for the corresponding vein is sometimes referred to as "V." For example, what is sometimes written as "arterial side ~" is sometimes written as "A side ~," and what is sometimes written as "venous side ~" is sometimes written as "V side ~." Furthermore, the term "drainage procedure" as used in this specification refers to the procedure of draining fluid within the blood circuit.

[0028] (Overall Configuration)

[0029] Figure 1 This is a piping diagram showing the configuration of the blood purification apparatus 100 related to the first embodiment. Figure 1 As shown, at the patient connection 11 of the debledation circuit, the debledation circuit can be connected to the patient's blood vessel, and at the patient connection 12 of the return circuit, the return circuit can be connected to the patient's blood vessel. After treatment, the patient connection 11 of the debledation circuit and the patient connection 12 of the return circuit are removed from the patient's body, so that the blood circuit 16 is interconnected in a closed loop. The patient connection 11 and the patient connection 12 can be interconnected by any connector. This will be referred to as AV connection state 13.

[0030] The blood purifier 100 includes an ACLP, an A chamber 14, a PCLP, an A pressure sensor 15, a blood circuit 16, a blood pump (BP1), a DI chamber 17, a DI pressure sensor 18, a blood purifier 19, a V chamber 20, a V pressure sensor 21, a VCLP, a solenoid valve 22, a discharge section 23, and a control device 24. The control device 24 controls the operation of the blood purifier 100 as described in this specification. Furthermore, the control device 24 is suitable for incorporating a CPU, ROM, RAM, and various interfaces.

[0031] ACLP is a clamp connected to the blood removal circuit, VCLP is a clamp connected to the blood return circuit, and PCLP is a clamp installed on the following line (pre-filling line) which introduces dialysate or saline into the blood circuit 16 during pre-filling, etc. The clamp can be a solenoid valve that closes or opens the blood circuit 16.

[0032] Chamber A 14 can capture air in the blood removal circuit. Chamber DI 17 can capture air in the blood flowing to the blood purifier 19. Chamber V 20 can capture air in the return blood circuit.

[0033] A-pressure sensor 15 is a pressure sensor used to measure the pressure within the blood circuit 16 in chamber A 14. DI-pressure sensor 18 is a pressure sensor used to measure the pressure within the blood circuit 16 in chamber DI 17. V-pressure sensor 21 is a pressure sensor used to measure the pressure within the blood circuit 16 in chamber V 20.

[0034] BP1 can deliver blood, saline solution, and air from the blood circuit 16 in a predetermined direction. When BP1 rotates clockwise, blood, saline solution, and air flow in the blood circuit 16 along a first direction 30; when BP1 rotates counterclockwise, blood, saline solution, and air flow in the blood circuit 16 along a second direction 40 opposite to the first direction 30. In this specification, clockwise rotation refers to rotation in a clockwise direction, and counterclockwise rotation refers to rotation in a counterclockwise direction.

[0035] The blood purifier 19 can be referred to as a dialyzer. The blood purifier 19 internally has a blood purification membrane, a blood inlet for introducing blood and a blood outlet for removing the introduced blood, a dialysate inlet for introducing dialysate and a dialysate outlet for discharging the introduced dialysate. The blood purifier 19 purifies the blood introduced through the blood inlet by bringing it into contact with the dialysate through the blood purification membrane.

[0036] The discharge section 23 is a degassing pump or dewatering pump that removes waste and water from the blood delivered from the blood purifier 19 through the drainage circuit. The drainage circuit is a circuit connecting the blood purifier 19 and the discharge section 23. Figure 1 The middle part is indicated by a dashed line. The solenoid valve 22 is installed between the blood purifier 19 and the discharge section 23. The discharge circuit is closed or opened by opening and closing the solenoid valve 22.

[0037] When draining fluid from an AV-connected blood circuit, the patient connection 11 of the de-bleeding circuit and the patient connection 12 of the return circuit must be indirectly connected via any connector or directly connected without a connector to make the blood circuit 16 a closed circuit. If the blood circuit 16 is connected to the patient and the draining process is not in the AV-connected state 13, there is a risk that air or residual fluid from the blood circuit will be introduced into the patient's body, and that de-bleeding will continue. Furthermore, even if the blood circuit 16 is disconnected from the patient and is not in the AV-connected state 13, residual fluid from the blood circuit may leak from the patient connection 11 of the de-bleeding circuit and / or the patient connection 12 of the return circuit if air is introduced into the blood circuit 16 from the pre-filling line or other locations, or if BP1 is rotated.

[0038] (Self-diagnosis operation procedure)

[0039] The following will refer to Figure 2 The self-diagnostic operation flow related to the first embodiment is described, which is performed when drainage begins in the AV-connected blood circuit. The purpose of the self-diagnosis is to confirm that the blood circuit 16 is in the AV-connected state 13, that is, in a closed-loop state.

[0040] In S201, the blood purification device 100 determines that the V pressure sensor 21 and the blood circuit 16 are connected. Specifically, the blood purification device 100 closes ACLP, VCLP and solenoid valve 22, opens PCLP, introduces air, saline or dialysate from the pre-fill line, and rotates BP1 clockwise. This operation pressurizes the V side.

[0041] Figure 3This diagram illustrates this state (first state). ACLP, VCLP, and solenoid valve 22 are in the closed state and can therefore be distinguished from PCLP. Because BP1 rotates forward, the introduced air, saline, or dialysate proceeds in the blood circuit 16 along the arrow in the first direction 30. Figure 3 In the diagram, the direction of air, saline, or dialysate flow is indicated by multiple arrows. This operation results in positive pressure on the V side.

[0042] Disabling ACLP and VCLP is to eliminate the risk of air bubbles entering the patient's body, even when the blood return circuit is connected to the patient. Conversely, if the blood depletion circuit is connected to the patient, it is to prevent blood depletion.

[0043] In S202, if the blood purifier 100 determines that the V side has been pressurized, it determines that the V pressure sensor 21 and the blood circuit 16 are connected, and the process proceeds to S203. The criterion for determining whether the V side has been pressurized can be a predetermined standard. On the other hand, if it determines that the V side has not been pressurized, it determines that the V pressure sensor 21 and the blood circuit 16 are not connected, and the process proceeds to S209.

[0044] In S203, the blood purification device 100 determines that side A is not connected to the patient. This determination is made because if the blood removal circuit were connected to the patient, blood would be removed from the patient's side. Specifically, the blood purification device 100 closes the PCLP, simultaneously opens the ACLP and solenoid valve 22, and rotates BP1 forward. Unlike the process in S201, the PCLP remains closed, therefore air, saline, or dialysate is not introduced into the blood circuit 16, and side A becomes negative pressure.

[0045] Figure 4 The diagram representing this state (second state) shows BP1 rotating positively with side A under negative pressure.

[0046] Because the forward rotation of BP1 causes the V pressure to rise, the blood purification device 100 can depressurize the downstream side (V side) by opening the solenoid valve 22.

[0047] In step S204, the blood purification device 100 determines that side A is not connected to the patient. Specifically, the blood purification device 100 closes the solenoid valve 22, stops the rotation of BP1, and uses the A-pressure sensor 15 to measure the subsequent change in A-pressure. BP1 is a peristaltic pump; when BP1 stops, BP1 partially closes, and VCLP~ACLP~BP1 forms a closed loop, maintaining negative pressure on side A. The condition for negative pressure on side A can be set to any condition, such as the change in A-pressure within a predetermined range within a predetermined time after BP1 stops.

[0048] Figure 5This diagram illustrates this state (third state). Although ACLP is open, PCLP and VCLP remain closed, and since BP1 has stopped, the pressure on side A remains negative.

[0049] In S205, if the pressure on side A remains negative, it is determined that side A is not connected to the patient, and the process proceeds to S206. On the other hand, if the negative pressure on side A is eliminated, it is determined that side A is connected to the patient or is open to the atmosphere, and the process proceeds to S209. Furthermore, if side A is connected to the patient, there is a risk of blood loss from the patient's body, but the control device 24 can limit the rotation of BP1 at S203 to allow for a small amount of blood loss.

[0050] In S206, the blood purification device 100 determines that the A side and V side of the blood circuit 16 are connected and in the AV connection state 13. Specifically, the blood purification device 100 opens the VCLP, thus opening the ACLP and VCLP, and measures the A pressure and V pressure respectively using the A pressure sensor 15 and the V pressure sensor 21, comparing the pressure difference between the two. The PCLP and the solenoid valve 22 are in the closed state. The condition for constituting the AV connection state 13 can be, for example, a reduction in the difference between the A pressure and V pressure, falling within a predetermined range. Opening the ACLP and VCLP is to balance (equalize) the pressures on the A side and V side.

[0051] Figure 6 This diagram illustrates this state (fourth state). BP1 stops, thus causing the residual liquid to move, thereby bringing the pressures on side A and side V into equilibrium. In this state, the blood purifier 100 measures the A pressure and V pressure using the A pressure sensor 15 and V pressure sensor 21 respectively, and compares the pressure difference between the two to determine whether the conditions for constituting the AV connection state 13 are met.

[0052] If it is determined in S207 that the condition of AV connection state 13 is met, the process proceeds to S208. On the other hand, if it is determined that the condition of AV connection state 13 is not met, the process proceeds to S209.

[0053] If the process proceeds to S208, according to the above process, the blood purification device 100 is able to self-diagnose that the blood circuit 16 is in the AV connection state 13 (closed loop state) before draining the blood in the AV connection type blood circuit.

[0054] In S208, with PCLP closed and solenoid valves 22, ACLP, and VCLP open, the blood purification device 100 begins the drainage operation within the AV-connected blood circuit. Figure 7This diagram illustrates the operation of draining fluid from the blood circuit 16 in the AV connection state 13. The blood purifier 100 introduces air from the upper part of the V chamber 20, the upper part of the A chamber 14, or any open portion of the blood circuit 16 (such as the PCLP, the upper part of the DI chamber 17, etc.), and rotates BP1 clockwise. If BP1 rotates clockwise, the residual fluid in the blood circuit 16... Figure 7 As shown, it flows in the first direction 30 and is discharged from the discharge section 23 through the blood purifier 19.

[0055] Furthermore, in one embodiment of the present invention, the rotation amount of BP1 can be arbitrarily controlled when the blood purifier 100 performs the drainage operation in S208. For example, the blood purifier 100 can start rotating with BP1 limited to a first rotation amount, and after a predetermined time, increase to a second rotation amount. The reason for controlling the rotation amount of BP1 in this way is to suppress the amount of blood loss from the patient's body even if the blood removal circuit is connected to the patient.

[0056] Although Figure 2 The operating procedure describes performing a drainage operation after determining that the blood circuit 16 is in a closed loop; however, the present invention is not limited to this embodiment. The blood purification device 100 can be configured such that, after starting the drainage operation, if it is determined that the blood circuit 16 is in a closed loop, the drainage operation continues as before; if it is not in a closed loop, the drainage operation is stopped at this time.

[0057] If the process proceeds to S209, some malfunctions occur due to the reasons mentioned above. Therefore, at S209, the blood purification device 100 will interrupt the drainage operation in the blood circuit 16.

[0058] Figure 8 A graph showing the A and V pressures from the first to the fourth state is displayed. In the normal AV connection state 13, the V pressure increases in S201 and then decreases in S206, while the A pressure decreases in S203 and increases in S206.

[0059] On the other hand, several abnormal connection states can be considered. First, if both side A and side V are connected to the patient, the pressure A will rise at S204, leading to an error. Second, if side A is open and side V is connected to the patient, air will be introduced from the blood removal circuit, so the pressure A will not change, leading to an error. Finally, if side A is occluded and side V is connected to the patient, the pressure V will continue to rise, while the pressure A will continue to decrease.

[0060] (Second Implementation)

[0061] The first embodiment describes an implementation where the puncture needle of the patient connection 11 in the blood removal circuit and the puncture needle of the patient connection 12 in the blood return circuit are respectively connected to the patient. The second embodiment describes the configuration of SNDP (Single Needle Dual Pump). Furthermore, single-needle dialysis is a method of performing dialysis by alternately and repeatedly removing and returning blood through a single path relative to the patient, using a dedicated puncture needle or tubing divided into two streams. Even in the case of a single needle, there are cases where the blood circuit is discarded after treatment due to drainage of fluid within the blood circuit; therefore, the self-diagnostic method for drainage of fluid within the blood circuit connected by the AV connection, as described in this invention, can be applied.

[0062] In the second embodiment, based on the configuration of the first embodiment, a second blood pump (BP2), an SN chamber 25, and an SN pressure sensor 26 are added. BP2 is a pump used to pressurize or depressurize the V side. The SN chamber 25 has the same components as the A chamber 14, DI chamber 17, and V chamber 20, and provides a buffering effect for accumulated pressure during single-needle treatment. The SN pressure sensor 26 is a pressure sensor used to measure the pressure in the blood circuit 16 within the SN chamber 25. (Refer to...) Figure 10 In the process of blood loss, when BP1 rotates and BP2 stops, pressure is stored in the SN chamber 25. On the other hand, during blood return, if BP1 stops and BP2 rotates, the blood stored in the SN chamber 25 is returned to the patient.

[0063] (Self-diagnosis operation procedure)

[0064] Figure 9 The diagram illustrates the self-diagnostic operation flow related to the second embodiment, which is implemented when draining fluid from the AV-connected blood circuit. Figure 9 Operation process and Figure 2 The operating procedure described is similar. The purpose of self-diagnosis is to confirm that the blood circuit 16 is in the AV connection state 13, that is, in a closed loop state.

[0065] In S901, the blood purification device 100 determines that the V-pressure sensor 21 and the blood circuit 16 are connected. Specifically, the blood purification device 100 closes ACLP, VCLP, and solenoid valve 22, opens PCLP, introduces air, saline, or dialysate from the pre-fill line, and rotates BP1 and BP2 clockwise. Through this operation, the V side is pressurized.

[0066] Figure 10 This diagram illustrates this state (fifth state). ACLP, VCLP, and solenoid valve 22 are in the closed state and can therefore be distinguished from PCLP. Because BP1 and BP2 rotate clockwise, the introduced air, saline solution, or dialysate advances in the blood circuit 16 along the arrow in the first direction 30. Figure 10In the diagram, the direction of air, saline, or dialysate flow is indicated by multiple arrows. This operation results in positive pressure on the V side.

[0067] Disabling ACLP and VCLP is to eliminate the risk of air bubbles entering the patient's body, even when the blood return circuit is connected to the patient. Conversely, if the blood depletion circuit is connected to the patient, it is to prevent blood depletion.

[0068] In S902, if the blood purifier 100 determines that the V side has been pressurized, it determines that the V pressure sensor 21 and the blood circuit 16 are connected, and the process proceeds to S903. The criterion for determining whether the V side has been pressurized can be a predetermined standard. On the other hand, if it determines that the V side has not been pressurized, it determines that the V pressure sensor 21 and the blood circuit 16 are not connected, and the process proceeds to S909.

[0069] In S903, the blood purification device 100 determines that side A is not connected to the patient. This determination is made because if the blood removal circuit were connected to the patient, blood would be removed from the patient's side. Specifically, the blood purification device 100 closes the PCLP, simultaneously opens the ACLP and solenoid valve 22, then rotates BP1 clockwise and BP2 counterclockwise. Unlike the process in S901, the PCLP remains closed, therefore air, saline, or dialysate is not introduced into the blood circuit 16, and side A becomes negative pressure.

[0070] Figure 11 This diagram illustrates this state (sixth state). BP1 rotates clockwise, therefore side A is under negative pressure. Furthermore, due to the counter-clockwise rotation of BP2, side V is depressurized.

[0071] Due to the forward rotation of BP1 and the reverse rotation of BP2, residual liquids such as blood in the blood circuit 16 are discharged from the discharge section 23 through the blood purifier 19 and the solenoid valve 22, and the V side is depressurized.

[0072] In S904, the blood purification device 100 determines that side A is not connected to the patient. Specifically, the blood purification device 100 closes the solenoid valve 22, stops the rotation of BP1 and BP2, and uses the A-pressure sensor 15 to measure the subsequent change in A-pressure. BP1 is a peristaltic pump; since BP1 stops, BP1 is partially blocked, and VCLP~ACLP~BP1 forms a closed loop, maintaining negative pressure on side A. The condition for negative pressure on side A can be set to any condition, such as the change in A-pressure within a predetermined range within a predetermined time after BP1 and BP2 stop.

[0073] Figure 12 To represent this state (seventh state) in a diagram, ACLP is open, but PCLP and VCLP remain closed, and the pressure on side A remains negative because BP1 has stopped.

[0074] In S905, if the pressure on side A remains negative, it is determined that side A is not connected to the patient, and the process proceeds to S906. On the other hand, if the negative pressure on side A is eliminated, it is determined that side A is connected to the patient or is open to the atmosphere, and the process proceeds to S909. Furthermore, if side A is connected to the patient, there is a risk of blood loss from the patient's body, but the control device 24 can limit the rotation of BP1 and BP2 at S903 to allow for minimal blood loss.

[0075] In S906, the blood purification device 100 determines that the A and V sides of the blood circuit 16 are connected and in the AV connection state 13. Specifically, the blood purification device 100 opens the ACLP and VCLP to the open state, measures the A pressure and V pressure respectively by the A pressure sensor 15 and V pressure sensor 21, and compares the pressure difference between the two. The PCLP and solenoid valve 22 are in the closed state. The condition for being in the AV connection state 13 can be, for example, a reduction in the difference between the A pressure and V pressure, which is within a predetermined range. Opening the ACLP and VCLP is to balance (equalize) the pressures on the A and V sides.

[0076] Figure 13 This diagram illustrates this state (eighth state). BP1 and BP2 stop, thus causing the residual liquid to move and bringing the pressures on sides A and V into equilibrium. In this state, the blood purification device 100 measures the pressure A and pressure V using the pressure sensor 15 and pressure sensor 21 respectively, and compares the pressure difference between the two to determine whether the conditions for constituting the AV connection state 13 are met.

[0077] If it is determined in S907 that the condition of AV connection state 13 is met, the process proceeds to S908. On the other hand, if it is determined that the condition of AV connection state 13 is not met, the process proceeds to S909.

[0078] If the process proceeds to S908, then according to the above process, the blood purification device 100 is able to self-diagnose that the blood circuit 16 is in the AV connection state 13 (closed loop state) before draining the blood circuit in the AV connection type.

[0079] In S908, with PCLP closed and solenoid valves 22, ACLP, and VCLP open, the blood purification device 100 begins the drainage operation in the AV-connected blood circuit. Air is introduced into the blood purification device 100 from the upper part of the V chamber 20, the upper part of the A chamber 14, or any open portion of the blood circuit 16 (e.g., the upper part of PCLP and DI chamber 17), causing BP1 to rotate clockwise and BP2 to rotate counterclockwise. When BP1 rotates clockwise, residual fluid in the blood removal circuit flows in the first direction 30, and residual fluid in the return blood circuit flows in the second direction 40, and is discharged from the discharge section 23 through the blood purifier 19.

[0080] Furthermore, in one embodiment of the present invention, the blood purification device 100 can arbitrarily control the rotation amount of BP1 during the drainage operation in S908. For example, the blood purification device 100 can start rotating BP1 at a first rotation amount and increase it to a second rotation amount after a predetermined time. The reason for controlling the rotation amount of BP1 in this way is to suppress the amount of blood loss from the patient's body even if the blood removal circuit is connected to the patient.

[0081] Although Figure 9 The operating procedure describes performing a drainage operation after determining that the blood circuit 16 is in a closed loop, but the present invention is not limited to this embodiment. The blood purifier 100 can be configured such that, if the blood circuit 16 is determined to be in a closed loop after the drainage operation begins, the drainage operation continues as before; if it is not in a closed loop, the drainage operation is stopped at this time.

[0082] If the process proceeds to S909, some malfunctions occur due to the reasons mentioned above. Therefore, at S909, the blood purification device 100 will interrupt the drainage operation in the blood circuit 16.

[0083] (Third Implementation)

[0084] The third embodiment is a configuration similar to the first embodiment, in which a third blood pump (BP3) is provided between the blood purifier 19 and the V chamber 20. The BP3 can be positioned in the same location as in the second embodiment. In other words, when the BP3 rotates clockwise, the V pressure increases, and when the BP3 rotates counterclockwise, the V pressure decreases. The following will refer to... Figure 2 The process description in the third embodiment shows the changes.

[0085] In S201, the blood purification device 100 closes ACLP, VCLP, and solenoid valve 22, opens PCLP, and introduces air from the pre-fill line, causing BP1 and BP3 to rotate forward. This operation pressurizes the V side. Compared to the first embodiment, due to the forward rotation of BP1 and BP3, positive pressure is achieved on the V side in a relatively short time.

[0086] In S203, the blood purification device 100 closes the PCLP while opening the ACLP and solenoid valve 22, then rotates BP1 clockwise and BP3 counterclockwise. Unlike the process in S201, the PCLP remains closed, so air is not introduced into the blood circuit 16, and side A becomes negative pressure. The blood purifier 100 can depressurize side V by counterclockwise rotation of BP3 and opening solenoid valve 22.

[0087] Thus, by using two blood pumps (BP1 and BP3) in the third embodiment, self-diagnosis can be performed more efficiently and in a shorter time than in the first embodiment.

[0088] (Embodiments of the present invention)

[0089] The first embodiment of the present invention is a blood purification device, comprising: a blood circuit having: a blood removal side circuit into which blood from a patient is desorbed flows; a blood return side circuit into which blood is returned to the patient, wherein one end of the blood removal side circuit and one end of the blood return side circuit are interconnected by a blood purifier, and the other end of the blood removal side circuit and the other end of the blood return side circuit are directly or indirectly interconnected, thereby forming a closed loop; a blood pump disposed in the blood circuit; a flow path switching unit capable of switching between an open state in which fluid can flow through one end of the blood removal side circuit and one end of the blood return side circuit, and a closed state in which fluid cannot flow through one end of the blood removal side circuit and one end of the blood return side circuit; a pressure detection unit for detecting the internal pressure of the blood circuit; and a control unit that, when the blood circuit is in the state of forming the closed loop, performs a drainage process, wherein the drainage process is to drain residual fluid in the blood circuit to a predetermined discharge location. The control unit performs the following control: further executes a judgment process, in which, when the flow path switching unit is switched to the closed state, after a pressure difference is generated between the blood loss side circuit and the blood return side circuit due to the rotation of the blood pump, the flow path switching unit is switched to the open state, and the pressure difference is monitored based on the detection result of the pressure detection unit to determine whether the blood circuit is a closed circuit. If it is determined to be a closed circuit in the judgment process, the drainage process is executed after the judgment.

[0090] Accordingly, the blood purification device can self-diagnose that the blood circuit is in the AV connection state when draining fluid from the AV-connected blood circuit.

[0091] The second embodiment of the present invention is that, in the first embodiment, the blood pump is a first blood pump provided in the blood removal side circuit, and the blood purification device further includes a second blood pump provided in the blood return side circuit. The control unit performs the following operation in the judgment process: when the flow path switching unit is switched to the closed state, after the first blood pump and the second blood pump are rotated in the first direction and a pressure difference is generated between the blood removal side circuit and the blood return side circuit, the flow path switching unit is switched to the open state, and the pressure difference is monitored based on the detection result of the pressure detection unit to determine whether the blood circuit is a closed circuit.

[0092] Accordingly, the blood purification device has the following effect: in the case of a dual-pump configuration, when draining fluid from an AV-connected blood circuit, it can self-diagnose that the blood circuit is in an AV-connected state.

[0093] In a third embodiment of the present invention, in the first or second embodiment, the pressure difference is the pressure difference when the blood loss side circuit is under negative pressure and the blood return circuit is under positive pressure.

[0094] Accordingly, the blood purification device has the following effect: the blood purification device can monitor the pressure difference when the blood removal side circuit is under negative pressure and the blood return side circuit is under positive pressure.

[0095] In the fourth embodiment of the present invention, in the first or second embodiment, the control unit determines whether the blood circuit is a closed circuit based on the monitoring result of the pressure difference in the above-mentioned judgment process. The monitoring result of the pressure difference indicates that the pressure difference generated between the blood loss side circuit and the blood return circuit has been reduced.

[0096] Accordingly, the monitoring results from the blood purification device indicate that the pressure difference between the de-blood side circuit and the return blood side circuit has been reduced.

[0097] The fifth embodiment of the present invention is that, in the first embodiment, the blood purification device further includes an inlet section for introducing a first fluid into the blood circuit, the first fluid for discharging residual liquid in the blood circuit, and when the flow path switching section is switched to the open state, the control device introduces the first fluid from the inlet section into the blood circuit, and at the same time, the residual liquid in the blood circuit is discharged to a predetermined discharge location by rotating the blood pump.

[0098] Accordingly, the blood purification device has the following effect: it can introduce the first fluid into the blood circuit and drain the residual liquid in the blood circuit to a predetermined discharge point by rotating the blood pump.

[0099] The sixth embodiment of the present invention is that, in the fifth embodiment, the introduced material is air, physiological saline or dialysate.

[0100] Accordingly, the blood purification device has the following effect: during the drainage process, air, saline or dialysate is introduced into the blood circuit.

[0101] The seventh embodiment of the present invention is a method based on a blood purification device, the blood purification device comprising: a blood circuit having: a de-bleeding side circuit in which de-bleeded blood from a patient flows; a return side circuit in which blood returns to the patient, wherein one end of the de-bleeding side circuit and one end of the return side circuit are interconnected by a blood purifier, and the other end of the de-bleeding side circuit and the other end of the return side circuit are directly or indirectly interconnected, thereby forming a closed loop; a blood pump disposed in the blood circuit; a flow path switching unit capable of switching between an open state in which fluid can flow through one end of the de-bleeding side circuit and one end of the return side circuit, and a closed state in which fluid cannot flow through one end of the de-bleeding side circuit and one end of the return side circuit; a pressure detection unit for detecting the internal pressure of the blood circuit; and a control unit that, when the blood circuit is in the state of forming the closed loop, performs a drainage process, the drainage process being to drain residual fluid in the blood circuit to a predetermined discharge location. The method includes the following steps: when the flow path switching unit is switched to the closed state, the control unit generates a pressure difference between the blood loss side circuit and the blood return side circuit by rotating the blood pump; and a judgment step in which the control unit switches the flow path switching unit to the open state and monitors the pressure difference based on the detection result of the pressure detection unit to determine whether the blood circuit is a closed circuit; if it is determined to be a closed circuit in the judgment step, the control unit performs the drainage process after the judgment.

[0102] Accordingly, the blood purification device can self-diagnose that the blood circuit is in the AV connection state when draining fluid from the AV-connected blood circuit.

[0103] While the principles of the present invention have been described above with reference to exemplary embodiments, those skilled in the art will understand that various embodiments with changes in configuration and details can be implemented without departing from the spirit of the invention. That is, the present invention can be implemented, for example, as a system, apparatus, method, program, or storage medium.

[0104] Symbol Explanation

[0105] 100 Blood Purification Devices

[0106] 11. Patient connection point of the de-hemorrhagic circuit

[0107] 12. Patient connection point of the return blood circuit

[0108] 13 AV connection status

[0109] 14 A chamber

[0110] 15 A pressure sensor

[0111] 16 Blood Circuit

[0112] 17 DI chamber

[0113] 18 DI pressure sensor

[0114] 19 Blood Purifier

[0115] 20 V chamber

[0116] 21 V voltage sensor

[0117] 22 Solenoid valve

[0118] 23 Discharge section

[0119] 24 Control Device

[0120] 25 SN chambers

[0121] 26 SN pressure sensor

[0122] 30 First Direction

[0123] 40. Second direction.

Claims

1. A blood purification device, the blood purification device comprising: A blood circuit having: a blood loss side circuit through which blood from the patient is depleted flows; and a blood return side circuit through which blood returns to the patient, wherein one end of the blood loss side circuit and one end of the blood return side circuit are interconnected by a blood purifier, and the other end of the blood loss side circuit and the other end of the blood return side circuit are directly or indirectly interconnected, thereby forming a closed circuit; A blood pump, which is installed in the aforementioned blood circuit; The flow path switching unit is capable of switching between an open state in which fluid can flow through one end of the blood loss side circuit and the blood return side circuit, and a closed state in which fluid cannot flow through one end of the blood loss side circuit and the blood return side circuit. The flow path switching unit is provided on the blood circuit that is directly or indirectly connected to the blood loss side circuit and the blood return side circuit. A pressure detection unit, used to detect the internal pressure of the aforementioned blood circuit; and When the blood circuit is in the state of forming the closed circuit, the control unit performs a drainage process, which is to drain the residual liquid in the blood circuit to a predetermined discharge location. The characteristic is that the control unit performs the following control: The judgment process is further performed. In this judgment process, when the flow path switching unit is switched to the closed state, after a pressure difference is generated between the blood loss side circuit and the blood return side circuit due to the rotation of the blood pump, the flow path switching unit is switched to the open state, and the pressure difference is monitored based on the detection result of the pressure detection unit to determine whether the blood circuit is a closed circuit. If the above-mentioned closed loop is determined in the above-mentioned judgment process, then the above-mentioned drainage process is executed after the judgment.

2. The blood purification device according to claim 1, characterized in that, The aforementioned blood pump is the first blood pump installed in the aforementioned blood loss side circuit. The aforementioned blood purification device also includes a second blood pump installed in the aforementioned blood return side circuit. The control unit described above performs the following operations during the judgment process: When the flow path switching unit is switched to the closed state, after the first blood pump and the second blood pump are rotated in the first direction to generate a pressure difference between the blood loss side circuit and the blood return side circuit, the flow path switching unit is switched to the open state, and the pressure difference is monitored based on the detection result of the pressure detection unit to determine whether the blood circuit is a closed circuit.

3. The blood purification device according to claim 1 or 2, characterized in that, The pressure difference mentioned above is the pressure difference when the blood loss side circuit is under negative pressure and the blood return side circuit is under positive pressure.

4. The blood purification device according to claim 1 or 2, characterized in that, In the aforementioned judgment process, the control unit determines whether the blood circuit is a closed circuit based on the monitoring results of the aforementioned pressure difference. The monitoring results of the pressure difference indicate that the pressure difference between the de-bleeding side circuit and the return side circuit has been reduced.

5. The blood purification device according to claim 1, characterized in that, The aforementioned blood purification device also includes an inlet section for introducing a first fluid into the blood circuit, the first fluid being used to drain residual fluid from the blood circuit. When the flow path switching unit is switched to the open state, the control unit introduces the first fluid from the inlet to the blood circuit, and at the same time, the residual liquid in the blood circuit is drained to a predetermined discharge point by rotating the blood pump.

6. The blood purification device according to claim 5, characterized in that, The first fluid mentioned above is air, saline, or dialysate.

7. A method based on a blood purification device, the blood purification device comprising: A blood circuit having: a blood loss side circuit in which blood from the patient is depleted flows in; and a blood return side circuit in which blood returns to the patient, wherein one end of the blood loss side circuit and one end of the blood return side circuit are interconnected by a blood purifier, and the other end of the blood loss side circuit and the other end of the blood return side circuit are directly or indirectly interconnected, thereby forming a closed circuit; A blood pump, which is installed in the aforementioned blood circuit; The flow path switching unit is capable of switching between an open state in which fluid can flow through one end of the blood loss side circuit and the blood return side circuit, and a closed state in which fluid cannot flow through one end of the blood loss side circuit and the blood return side circuit. The flow path switching unit is provided on the blood circuit that is directly or indirectly connected to the blood loss side circuit and the blood return side circuit. A pressure detection unit, used to detect the internal pressure of the aforementioned blood circuit; and When the blood circuit is in the state of forming the closed circuit, the control unit performs a drainage process, which is to drain the residual liquid in the blood circuit to a predetermined discharge location. Its features include the following steps: When the flow path switching unit switches to the closed state, the control unit generates a pressure difference between the blood loss side circuit and the blood return side circuit by rotating the blood pump; and In the determination step, the control unit switches the flow path switching unit to the open state and monitors the pressure difference based on the detection result of the pressure detection unit to determine whether the blood circuit is a closed circuit. If the above-mentioned closed loop is determined in the above-mentioned judgment step, then the above-mentioned control unit executes the above-mentioned drainage process after the judgment.

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