Blood purification device

Abstract

The present application provides a blood purification device, which can reduce the amount of priming fluid applied to a patient together with an anticoagulant before blood purification treatment. The blood purification device comprises a control unit configured to control a blood pump (4) and a priming pump (5). The control unit (9) is configured to: start the priming pump (5) by providing a drive signal to the priming pump (5) in a state in which a blood circuit is filled with the priming fluid; cause the blood pump (4) to perform a first operation by providing a first drive signal to the blood pump (4) in a state in which the anticoagulant is injected into the blood circuit by the start of the priming pump (5); and provide a second drive signal to the blood pump (4) in a state in which the anticoagulant is delivered to a distal end of an arterial blood circuit (1) and / or a distal end of a venous blood circuit (2) by the first operation of the blood pump (4) and a patient is punctured by the distal end of the arterial blood circuit (1) and the distal end of the venous blood circuit (2).

Description

Technical Field

[0001] The present invention relates to a blood purification device configured to purify a patient’s blood by circulating blood outside the body through blood circuits (including arterial blood circuits and venous blood circuits) and a blood purifier. Background Technology

[0002] A dialysis device used as a blood purification apparatus typically includes a tubing section and a fluid delivery section. The tubing section includes a dialysate inlet line for introducing dialysate into the blood purifier and a drain line for draining wastewater from the blood purifier. The fluid delivery section is used to deliver the dialysate and wastewater within the tubing section. This dialysis device is formed by connecting a blood purifier to a blood circuit, which circulates the patient's blood outside the body. The dialysis device is configured to perform dialysis treatment (blood purification therapy) at the blood purifier while simultaneously circulating the patient's blood outside the body through the blood circuit.

[0003] On the other hand, to prevent blood clotting, an anticoagulant needs to be injected into the patient before extracorporeal circulation of the blood during blood purification therapy. To ensure the anticoagulant effectively inhibits blood clotting, blood purification therapy needs to be performed after a predetermined time (e.g., approximately 3 to 5 minutes) following the injection of the anticoagulant. Therefore, as described in Patent Document 1, a proposed blood purification device is configured to perform blood purification therapy after a predetermined time has elapsed following the injection of the pre-injected anticoagulant along with a pre-filled solution into the patient's body.

[0004] Existing technical documents

[0005] Patent documents

[0006] Patent Document 1: JP 2020-14851 Summary of the Invention

[0007] Technical issues

[0008] However, in the aforementioned blood purification devices, if, for example, the flow path used to inject the anticoagulant into the patient is relatively long from the injection point to the patient, excess pre-filling fluid equivalent to the pre-filling capacity of that flow path will be injected into the patient along with the anticoagulant. Patients are typically in a state of fluid excess before receiving blood purification treatment. Therefore, it is not advisable to inject excessive pre-filling fluid into patients in a state of fluid excess.

[0009] The present invention was conceived with the above-mentioned circumstances in mind, and provides a blood purification device that can reduce the amount of pre-filled fluid injected into the patient along with an anticoagulant before blood purification treatment.

[0010] Solution to the problem

[0011] According to an embodiment of the present invention, a blood purification device purifies a patient's blood by circulating blood extracorporeally through a blood circuit and a blood purifier, the blood circuit including an arterial blood circuit and a venous blood circuit. The blood purification device includes: a blood pump configured to circulate blood in the blood circuit for extracorporeal circulation; an injection pump configured to inject an anticoagulant into a predetermined location; and a control unit configured to control the blood pump and the injection pump. The control unit is configured to: activate the injection pump by providing a drive signal when the blood circuit is filled with pre-filled fluid; perform a first operation by providing a first drive signal to the blood pump when the anticoagulant is injected into the blood circuit by activation of the injection pump; and provide a second drive signal to the blood pump when the anticoagulant is delivered to the distal end of the arterial blood circuit and / or the distal end of the venous blood circuit by the first operation of the blood pump and the patient has undergone puncture at the distal end of the arterial blood circuit and the distal end of the venous blood circuit.

[0012] Technical effects of the invention

[0013] According to the present invention, with the blood circuit filled with pre-filled fluid, the injection pump is activated by providing a drive signal to the injection pump; while the anticoagulant is injected into the blood circuit by the activation of the injection pump, the blood pump performs a first operation by providing a first drive signal to the blood pump; and while the anticoagulant is delivered to the distal end of the arterial blood circuit and / or the distal end of the venous blood circuit by the first operation of the blood pump and the patient has undergone punctures through the distal ends of the arterial and venous blood circuits, a second drive signal is provided to the blood pump. This reduces the amount of pre-filled fluid injected into the patient along with the anticoagulant before blood purification treatment. Attached Figure Description

[0014] [ Figure 1 [A schematic diagram of a blood purification device according to an embodiment of the present invention.]

[0015] [ Figure 2 [Flowchart of the entire process performed by the blood purification device.]

[0016] [ Figure 3 [Flowchart of the preparation steps performed by the blood purification device.]

[0017] [ Figure 4 [A schematic diagram of the blood purification device in the pre-charging stage.]

[0018] [ Figure 5 [A schematic diagram of the blood purification device in the injection step.]

[0019] [ Figure 6[A schematic diagram of the blood purification device in the delivery step (delivering only to the distal end of the venous blood circulation).]

[0020] [ Figure 7 [A schematic diagram showing the blood purification device with its puncture needle installed.]

[0021] [ Figure 8 [A schematic diagram of the blood purification device in the application step state.]

[0022] [ Figure 9 [A schematic diagram of the blood purification device in the blood purification treatment process.]

[0023] [ Figure 10 [A block diagram of the peripheral components of the control unit included in the blood purification device.]

[0024] [ Figure 11 [A schematic diagram of the blood purification device in the delivery step (delivering only to the distal end of the arterial blood circulation).]

[0025] [ Figure 12 [A schematic diagram of the blood purification device in the delivery step (delivering blood to the distal end of the arterial and venous circulation).]

[0026] [ Figure 13 The schedule for the operation of the peripheral components of the control unit included in the blood purification device (in the state of only delivering blood to the distal end of the venous circuit).

[0027] [ Figure 14 The schedule for the operation of the peripheral components of the control unit included in the blood purification device (in the state of only delivering blood to the distal end of the arterial circulation).

[0028] [ Figure 15 The schedule for the operation of the peripheral components of the control unit included in the blood purification device (in the state of delivering blood to the distal end of the arterial and venous circulation).

[0029] [ Figure 16 [A schematic diagram of a blood purification device according to another embodiment of the present invention.] Detailed Implementation

[0030] The embodiments of the present invention will now be described in detail with reference to the accompanying drawings.

[0031] According to this embodiment, the blood purification device is configured to purify a patient's blood by circulating blood outside the body through blood circuits (including arterial blood circuits and venous blood circuits) and a blood purifier. For example... Figure 1As shown, the blood purification device includes: a blood circuit comprising an arterial blood circuit 1 and a venous blood circuit 2; a dialyzer 3, which functions as a blood purifier; a blood pump 4; an infusion pump 5; a dialysis unit 8, which is capable of supplying dialysate to the dialyzer 3; and a control unit 9.

[0032] The distal end of the arterial blood circuit 1 is provided with a connector 1a. Arterial puncture needle a (see...) Figure 7 and Figure 8 It can be connected to the arterial blood circuit 1 via connector 1a. The peristaltic blood pump 4 is located at the midpoint of the arterial blood circuit 1. The blood pump 4 is a pump located at a predetermined position in the arterial blood circuit 1, used to flow blood and pre-filled fluid in the blood circuit upon startup.

[0033] On the other hand, a connector 2a is provided at the distal end of the venous blood circuit 2. (See also: venous puncture needle b) Figure 7 and Figure 8 It can be connected to the venous blood circuit 2 via connector 2a. An air trap chamber 6 is provided at the midpoint of the venous blood circuit 2. The air trap chamber 6 is a chamber connected to a predetermined position in the venous blood circuit 2 for trapping and removing air contained in the extracorporeal circulating blood.

[0034] Clamping devices K1 and K2, both of which are solenoid valves, are provided at the distal ends of arterial blood circuit 1 and venous blood circuit 2, respectively. Opening clamping device K1 or K2 opens the flow path at the distal end of arterial blood circuit 1 or venous blood circuit 2. Closing clamping device K1 or K2 closes the flow path at the distal end of arterial blood circuit 1 or venous blood circuit 2.

[0035] The dialyzer 3 (blood purifier) ​​housing has a blood inlet 3a, a blood outlet 3b, a dialysate inlet 3c, and a dialysate outlet 3d. Arterial blood circuit 1 is connected to blood inlet 3a. Venous blood circuit 2 is connected to blood outlet 3b. Dialysate inlet 3c and dialysate outlet 3d are connected to dialysate inlet line L1 and drain line L2, respectively.

[0036] The dialyzer 3 contains multiple hollow fiber membranes (not shown), which constitute a blood purification membrane for purifying the blood. The hollow fiber membranes constituting the blood purification membrane have a number of micropores (pores) extending from the outer surface to the inner surface. Impurities and other substances contained in the blood can pass through the hollow fiber membrane into the dialysate, thereby achieving purification.

[0037] Both the dialysate inlet line L1 (through which dialysate is introduced into dialyzer 3) and the drain line L2 (through which drain is discharged from dialyzer 3) extend from the dialysis apparatus 8. One end of the dialysate inlet line L1 is connected to dialyzer 3 (dialysate inlet 3c), and the other end is connected to a dialysate preparation device (not shown), which is used to prepare dialysate of a predetermined concentration. Thus, dialysate of the predetermined concentration is introduced into dialyzer 3.

[0038] One end of the drain line L2 is connected to the dialyzer 3 (dialysis fluid outlet 3d), and the other end is connected to the drain device (not shown). Therefore, after the dialyzer fluid supplied by the dialyzer fluid supply device flows through the dialyzer fluid inlet line L1 and reaches the dialyzer 3, the drain fluid from the dialyzer 3 flows through the drain line L2 and reaches the drain device. The dialysis apparatus 8 is equipped with a liquid delivery pump for transporting the dialyzer fluid and the drain fluid, and an ultrafiltration pump (not shown) for removing water from the patient's blood flowing in the dialyzer 3.

[0039] When the blood pump 4 is activated while the patient has undergone arterial puncture (connected to the distal end of arterial blood circuit 1) and venous puncture (connected to the distal end of venous blood circuit 2), the patient's blood flows through arterial blood circuit 1 and reaches dialyzer 3 for blood purification treatment. Then, the blood flows through venous blood circuit 2 and returns to the patient. Therefore, while the patient's blood is being purified in dialyzer 3, it is also circulating extracorporeally through the blood circuits.

[0040] According to this embodiment, the arterial blood circuit 1 has a saline line L3 between the connector 1a and the location of the blood pump 4. A container 7 is connected to the distal end of the saline line L3. The container 7 contains a predetermined amount of pre-filling fluid (saline). The saline line L3 is equipped with a clamping device K3, which is a solenoid valve. Opening the clamping device K3 opens the saline line L3, thereby supplying the pre-filling fluid in the container 7 to the blood circuit. Closing the clamping device K3 closes the saline line L3, thereby stopping the supply of pre-filling fluid to the blood circuit.

[0041] The arterial blood circuit 1 according to this embodiment is further provided with an anticoagulant injection line L4, which is located between the location where the blood pump 4 is provided and the location where the arterial blood circuit 1 is connected to the dialyzer 3. A syringe M is connected to the distal end of the anticoagulant injection line L4. The syringe M contains a predetermined amount of anticoagulant (heparin H in this embodiment). The syringe M is installed in the infusion pump 5 within the dialysis apparatus 8. The syringe M is capable of injecting the predetermined amount of anticoagulant contained therein, and a plunger (not shown) within the infusion pump 5 causes the piston of the syringe M to slide.

[0042] Heparin H, used as an anticoagulant, consists of, for example, unfractionated heparin and low molecular weight heparin. Heparin H is typically administered initially before blood purification therapy (dialysis). If necessary, heparin H can also be administered continuously during blood purification therapy (continuous administration). In addition to heparin, any other anticoagulant with anticoagulant properties can be injected.

[0043] In this embodiment, the volume between the connection of the anticoagulant injection line L4 and the distal end of the arterial blood circuit 1 is 45.1 ml, and the flow rate of the blood pump 4 is 8.696 ml / revolution. Under these conditions, in the delivery step described below, the blood pump 4 is rotated counterclockwise approximately 6 revolutions (52.2 ml) to deliver heparin H from the anticoagulant injection line L4 to a position near the distal end of the venous blood circuit 2; in the application step described below, the blood pump 4 is connected to the patient and rotated clockwise approximately 2 revolutions (17.4 ml) to apply heparin H from the venous blood circuit 2 to the patient. It should be noted that the volume of the blood circuit may vary depending on the device type and needs to be confirmed beforehand and set accordingly in the device. The number of rotations required in the delivery and application steps needs to be verified experimentally beforehand to determine how much heparin H diffuses during the delivery step.

[0044] Control unit 9 is a microcomputer or similar device (specifically, it is...) Figure 10 The microcomputer 9a shown is included in the dialysis apparatus 8. The control unit 9 is electrically connected to the blood pump 4, the infusion pump 5, and the clamping devices (K1 to K3). The control unit 9 controls the starting of the blood pump 4 and the infusion pump 5, as well as the operation of the clamping devices (K1 to K3), thereby enabling the execution of: a pre-filling step, which fills the blood circuit with pre-filling fluid; and a blood purification treatment step, which purifies the patient's blood at the dialyzer 3 while simultaneously circulating the blood extracorporeally through the blood circuit.

[0045] According to this embodiment, after the pre-filling step, the control unit 9 can sequentially perform the following steps: an injection step, which injects an anticoagulant (heparin H) into the blood circuit by activating the injection pump 5; a delivery step, which delivers the heparin H injected in the injection step to the distal end of the arterial blood circuit 1 and / or the distal end of the venous blood circuit 2 by activating the blood pump 4; an application step, which, while the patient is punctured at the distal end of the arterial blood circuit 1 and the distal end of the venous blood circuit 2, applies the heparin H delivered in the delivery step to the patient by activating the blood pump 4; and a standby step, which remains in standby mode after the application step until a predetermined time expires.

[0046] Now, refer to Figure 2 and Figure 3 The flowchart shown describes the control process executed by the control unit 9 according to this embodiment.

[0047] First, such as Figure 4As shown, connector 1a at the distal end of arterial blood circuit 1 and connector 2a at the distal end of venous blood circuit 2 are connected to form a closed loop. Then, with clamping device K3 open, blood pump 4 is started (normally rotated). This performs pre-filling step S1, in which pre-filling fluid (physiological saline) in container 7 is injected into and fills the blood circuit. In pre-filling step S1, the pre-filling fluid in container 7 circulates within the closed loop formed by arterial blood circuit 1 and venous blood circuit 2, and is discharged to the outside through overflow line La extending from the top of air trap chamber 6. Thus, the closed loop is filled with pre-filling fluid. It should be noted that the pre-filling method is not limited to the above method. Various other pre-filling methods can be used for the pre-filling step.

[0048] After the pre-charging step S1, the process proceeds to the application preparation step S2. The application preparation step S2 includes the following steps: [e.g., ...] Figure 3 As shown, in step S201, the first and second solenoid valves (clamping devices K1 and K2) open, while the third solenoid valve (clamping device K3) closes. In step S202, a drive signal is sent to the actuator P2 of the injection pump 5, thereby starting the injection pump 5. Figure 5 Subsequently, in step S203, a first drive signal is sent to the actuator P1 of the blood pump 4. Therefore, as... Figure 6 As shown, blood pump 4 is activated to deliver heparin H (delivery step). Furthermore, in step S204, the first and second solenoid valves (clamping devices K1 and K2) are closed, while the third solenoid valve (clamping device K3) remains closed (see...). Figure 7 In addition, in step S205, it is determined whether a signal indicating completion of puncture at the distal end of arterial blood circuit 1 and venous blood circuit 2 has been received.

[0049] If it is determined in step S205 that signals indicating completion of puncture at the distal end of arterial blood circuit 1 and the distal end of venous blood circuit 2 have been received, the process proceeds to step S3. Figure 8 As shown, in step S3, the patient has undergone puncture via arterial needle a and venous needle b. At this time, blood pump 4 rotates normally, clamping device K1 is closed, clamping device K2 is open, and clamping device K3 is open. Therefore, heparin H located at the distal end of venous blood circuit 2 (the part near connector 2a) is applied to the patient's body through venous needle b. It should be noted that the amount of heparin H to be injected in step S3 can be estimated based on the rotational speed of blood pump 4.

[0050] After step S3, a standby step S4 is executed, in which blood pump 4 and infusion pump 5 are stopped and placed in standby mode until a predetermined time (e.g., about 3 to 5 minutes) expires. During standby step S4, the standby period until the predetermined time expires activates the heparin H applied to the patient, thereby significantly enhancing its anticoagulation effect and inhibiting blood clotting. The patient's blood will then circulate extracorporeally in blood purification treatment step S5.

[0051] like Figure 9 As shown, after standby step S4, the arterial puncture needle a and venous puncture needle b remain inserted into the patient, and the blood pump 4 rotates normally. Simultaneously, dialysate is introduced into the dialyzer 3 through dialysate inlet line L1, and drained fluid is discharged through drain line L2. This executes blood purification treatment step S5, in which the patient's blood is purified in the dialyzer 3 while simultaneously circulating extracorporeally through the blood circuit.

[0052] In the conveying step of this embodiment, such as Figure 6 As shown, heparin H is only delivered to the distal end of venous circulation 2. Or, as... Figure 11 As shown, heparin H can be delivered only to the distal end of arterial blood circulation 1, or as... Figure 12 As shown, it is delivered to the distal end of arterial blood circulation 1 and the distal end of venous blood circulation 2.

[0053] Now, refer to Figure 10 The block diagram shown illustrates the peripheral components of the control unit 9 in this embodiment and the control operations of the peripheral components.

[0054] like Figure 10 As shown, according to this embodiment, the control unit 9 includes a microcomputer 9a. The microcomputer 9a is electrically connected to the touch panel 10a of the input unit 10, thereby receiving input signals from the touch panel 10a. The microcomputer 9a is connected to the drive unit 11. The drive unit 11 includes an actuator P1 for the blood pump 4, an actuator P2 for the injection pump 5, a drive coil J1 for the clamping device K1 (first solenoid valve), a drive coil J2 for the clamping device K2 (second solenoid valve), and a drive coil J3 for the clamping device K3 (third solenoid valve).

[0055] In this embodiment, the microcomputer 9a of the control unit 9 is configured to perform the following: when the blood circuit is filled with pre-filled fluid, start the injection pump 5 by providing a drive signal to the actuator P2 of the injection pump 5; after the injection pump 5 is started, start the blood pump 4 by providing a first drive signal to the actuator P1 of the blood pump 4 to perform a first operation, injecting anticoagulant into the blood circuit; and after the first operation of the blood pump 4, start the blood pump 4 by providing a second drive signal to the actuator P1 of the blood pump 4 to perform a second operation, delivering anticoagulant to the distal end of the arterial blood circuit 1 or the distal end of the venous blood circuit 2, and perform puncture on the patient using the distal end of the arterial blood circuit 1 and the distal end of the venous blood circuit 2.

[0056] Furthermore, this embodiment employs a first solenoid valve (clamping device K1) configured to open and close the end of the arterial blood circuit 1; a second solenoid valve (clamping device K2) configured to open and close the end of the venous blood circuit 2; and a third solenoid valve (clamping device K3) configured to open and close the supply line for providing dialysate. The microcomputer 9a of the control unit 9 is configured to execute: before injecting anticoagulant, opening the first and second solenoid valves and closing the third solenoid valve; after the anticoagulant is delivered to the distal end of the arterial blood circuit 1 or the distal end of the venous blood circuit 2, closing the first and second solenoid valves; and closing the third solenoid valve.

[0057] Now, refer to Figure 13 The timing diagram shown illustrates the control unit 9 and peripheral components of this embodiment, as well as the control operations of the peripheral components. This timing diagram assumes that heparin H is only delivered to the distal end of the venous blood circuit 2 (see [link to original document]). Figure 6 ).

[0058] During the pre-charge step (600 seconds), the blood pump actuator P1 is turned on (with a drive signal for normal rotation), causing the blood pump 4 to rotate normally; simultaneously, the injection pump actuator P2 is turned off (without a drive signal), causing the injection pump 5 to turn off. Furthermore, the drive coils J1, J2, and J3 of the clamping solenoid valves are also turned on (with drive signals), thereby opening the flow path. Although this embodiment relates to the case where the clamping solenoid valves (J1 to J3) are closed in the initial state (without a drive signal), the solenoid valves can also be opened in the initial state.

[0059] During the injection step (60 seconds), the blood pump actuator P1 is turned off (no drive signal), thus stopping the blood pump 4, while the injection pump actuator P2 is turned on (drive signal present), thus starting the injection pump 5. Furthermore, the drive coils J1 and J2 of the clamping solenoid valve are turned on (drive signal present), thus opening the flow path, while the drive coil J3 of the clamping solenoid valve is turned off (no drive signal present), thus closing the flow path.

[0060] During the delivery step (60 seconds), the blood pump actuator P1 is turned on (with a reverse rotation drive signal), causing the blood pump 4 to rotate in reverse; simultaneously, the injection pump actuator P2 is turned off (without a drive signal), thus stopping the injection pump 5. Furthermore, the drive coils J1 and J2 of the clamping solenoid valve are turned on (with drive signals), thus opening the flow path; simultaneously, the drive coil J3 of the clamping solenoid valve is turned off (without a drive signal), thus closing the flow path.

[0061] During the subsequent puncture procedure, the blood pump actuator P1 is turned off (no drive signal), thus stopping the blood pump 4, and the injection pump actuator P2 is turned off (no drive signal), thus stopping the injection pump 5. Furthermore, the drive coils J1, J2, and J3 of the clamping solenoid valve are turned off (no drive signal), thus closing the flow path.

[0062] During the intravenous application step (60 seconds), the blood pump actuator P1 is turned on (with a drive signal indicating normal rotation), causing the blood pump 4 to rotate normally; simultaneously, the injection pump actuator P2 is turned off (without a drive signal), thus stopping the injection pump 5. Furthermore, the drive coils J2 and J3 of the clamping solenoid valve are turned on (with drive signals), opening the flow path; simultaneously, the drive coil J1 of the clamping solenoid valve is turned off (without a drive signal), closing the flow path.

[0063] During the standby phase (600 seconds), the blood pump actuator P1 is turned off (no drive signal), thereby stopping the blood pump 4, and the injection pump actuator P2 is turned off (no drive signal), thereby stopping the injection pump 5. Furthermore, the drive coils J1, J2, and J3 of the clamping solenoid valve are turned off (no drive signal), thereby closing the flow path.

[0064] At the start of the blood purification treatment step (4 hours), the blood pump actuator P1 is turned on (with a drive signal indicating normal rotation), causing the blood pump 4 to rotate normally; simultaneously, the injection pump actuator P2 is turned off (without a drive signal), thus stopping the injection pump 5. Furthermore, the drive coils J1 and J2 of the clamping solenoid valve are turned on (with drive signals), opening the flow path; simultaneously, the drive coil J3 of the clamping solenoid valve is turned off (without a drive signal), closing the flow path.

[0065] Now, refer to Figure 14 The timing diagram shown illustrates the control unit 9, peripheral components, and their control operations in this embodiment. This timing diagram assumes that heparin H is only delivered to the distal end of the arterial blood circuit 1 (see...). Figure 11 The pre-filling, injection, delivery, puncture, standby, and treatment steps are the same as when heparin H is only delivered to the distal end of venous blood circuit 2.

[0066] During the arterial application steps (1 second and 2 seconds), the following states are repeatedly established the required number of times: the blood pump actuator is turned on (with a drive signal for normal rotation) to make the blood pump 4 rotate normally, the injection pump actuator P2 is turned off (without a drive signal) to stop the injection pump 5, the clamping solenoid valve drive coil J3 is turned on (with a drive signal) to open the flow path, and the clamping solenoid valve drive coils J1 and J2 are turned off (without a drive signal) to close the flow path; and the blood pump actuator P1 is turned on (with a drive signal for reverse rotation) to make the blood pump 4 rotate in reverse, the injection pump actuator P2 is turned off (without a drive signal) to stop the injection pump 5, the clamping solenoid valve drive coil J1 is turned on (with a drive signal) to open the flow path, and the clamping solenoid valve drive coils J2 and J3 are turned off (without a drive signal) to close the flow path.

[0067] Now, refer to Figure 15 The timing diagram shown illustrates the control unit 9 and peripheral components of this embodiment, as well as the control operations of the peripheral components. This timing diagram assumes that heparin H is delivered to the distal ends of the arterial blood circuit 1 and the venous blood circuit 2 (see...). Figure 12 The pre-filling, injection, delivery, puncture, standby, intravenous application, and treatment steps are the same as when heparin H is only delivered to the distal end of venous blood circuit 2. The arterial application step is the same as when heparin H is only delivered to the distal end of arterial blood circuit 1.

[0068] According to this embodiment, after the pre-filling step S1, the control unit 9 sequentially executes: an injection step, which injects the anticoagulant into the blood circuit by activating the injection pump 5; a delivery step, which delivers the anticoagulant injected in the injection step to the distal end of the arterial blood circuit 1 and the distal end of the venous blood circuit 2 by performing a first operation of the injection pump; and an application step S3, which, while the patient has punctures at the distal ends of the arterial blood circuit 1 and the venous blood circuit 2, applies the anticoagulant delivered in the delivery step to the patient by performing a second operation of the injection pump 4. This process reduces the amount of pre-filling fluid (physiological saline) that needs to be applied to the patient along with the anticoagulant before blood purification treatment.

[0069] Furthermore, reducing the amount of pre-filled fluid can decrease the cardiac load caused by excess fluid (preventing elevated blood pressure). Moreover, enhanced anticoagulation can reduce the amount of heparin needed, thereby lowering the cost of anticoagulants (heparin) and reducing their side effects. Additionally, current technology requires medical personnel to measure the standby cycle and wait for treatment to begin, while the automated operation of the device can eliminate this task for medical personnel.

[0070] According to this embodiment, the control unit 9 is configured to execute a standby step after a predetermined time following the application step. As a result, heparin H applied to the patient is activated, thereby effectively enhancing its anticoagulation effect. Therefore, in the blood purification treatment step S5, blood coagulation in the patient is suppressed.

[0071] In the pre-filling step S1 of this embodiment, the distal ends of the arterial blood circuit 1 and the venous blood circuit 2 are connected to form a closed loop, and pre-filling fluid (physiological saline) is injected into this closed loop. This closed loop is maintained in both the injection step and the delivery step. Therefore, the closed loop formed in the pre-filling step S1 is used to perform the injection step and the delivery step.

[0072] In the delivery step of this embodiment, the blood pump 4 rotates in the reverse direction to deliver heparin H to the distal ends of the arterial blood circuit 1 and the venous blood circuit 2. Therefore, the heparin H injected in the injection step does not flow through the dialyzer 3, and its delivery to the distal ends of the arterial blood circuit 1 and the venous blood circuit 2 can be ensured.

[0073] In the application step S3 of this embodiment, the blood pump 4 rotates forward to apply heparin H from the distal end of the venous blood circuit 2 to the patient; and the blood pump 4 rotates in reverse to apply heparin H from the distal end of the arterial blood circuit 1 to the patient. Therefore, heparin H from both the distal end of the venous blood circuit 2 and the distal end of the arterial blood circuit 1 can be ensured to be applied to the patient.

[0074] While one embodiment has been described above, the invention is not limited thereto. For example, the invention can be applied to... Figure 16 The configuration shown indicates that the supply line Lb is connected to the dialysate inlet line L1 at a predetermined location (in...) between the arterial blood circuit 1 and the dialysate inlet line L1. Figure 16 Between the connector 1a and the location of the blood pump 4, a clamping device K3 is provided at the midpoint of the supply line Lb. This clamping device K3 is composed of a solenoid valve. In this configuration, the pre-filling fluid to be supplied in the pre-filling step is dialysate supplied through the supply line Lb, and when the clamping device K3 is opened, the pre-filling fluid can be delivered to the blood circuit.

[0075] Step S3 can be performed as follows: When heparin H is delivered to the distal end of arterial blood circuit 1, with clamping device K2 closed, blood pump 4 rotates forward, thereby supplying pre-filled fluid (physiological saline or dialysate) to air trap chamber 6 to build up pressure. Subsequently, blood pump 4 rotates in reverse, causing the pressurized pre-filled fluid to flow into arterial blood circuit 1, thereby applying heparin H located at the distal end of arterial blood circuit 1 to the patient.

[0076] In this case, such as Figure 14 or Figure 15As shown, the control unit 9 is capable of performing: a pressure accumulation step (1 second), which accumulates pressure between the positions of the blood pump 4 and the clamping device K2 by rotating the blood pump 4 in the forward direction and closing the flow path of the clamping device K2; and an application step (2 seconds), which applies heparin H from the distal end of the arterial blood circuit 1 by rotating the blood pump 4 in the reverse direction and closing the flow path of the clamping device K2. The pressure accumulation step is controlled by the control unit 9, which increases and accumulates the pressure within the air trap chamber 6 by rotating the blood pump 4 in the forward direction and closing the clamping devices K1 and K2 while opening the clamping device K3. The pressure accumulation step can store and retain a predetermined amount of pre-filled fluid for applying heparin H from the distal end of the arterial blood circuit 1. Preferably, a pressure sensor is provided in the air trap chamber 6 to detect and monitor the pressure during pressure accumulation.

[0077] After heparin H is delivered only to the distal end of arterial blood circuit 1 or venous blood circuit 2 in the delivery step, in the application step S3, the blood pump 4 can be rotated forward or backward to apply the heparin H located at the distal end of arterial blood circuit 1 or venous blood circuit 2 to the patient. This operation can shorten the duration of the application step S3.

[0078] If heparin H is delivered to both arterial circulation 1 and venous circulation 2 simultaneously, then according to this embodiment, application step S3 is performed, such that heparin H is first applied to the patient from the distal end of venous circulation 2, and then from the distal end of arterial circulation 1. Alternatively, heparin H may be applied to the patient first from the distal end of arterial circulation 1, and then from the distal end of venous circulation 2, or alternately from the distal ends of arterial circulation 1 and venous circulation 2.

[0079] According to a first aspect of the present invention, a blood purification device is provided, configured to purify a patient's blood by circulating blood outside the body through a blood circuit and a blood purifier, the blood circuit including an arterial blood circuit 1 and a venous blood circuit 2, the blood purification device comprising: a blood pump 4 configured to circulate blood in the blood circuit for extracorporeal circulation; an injection pump 5 configured to inject an anticoagulant into a predetermined location; and a control unit 9 configured to control the blood pump 4 and the injection pump 5. The control unit 9 is configured to perform the following process: When the blood circuit is filled with pre-filled fluid, the injection pump 5 is activated by providing a drive signal to the injection pump 5; when the anticoagulant is injected into the blood circuit by activating the injection pump 5, the blood pump 4 is operated by providing a first drive signal to the blood pump 4; and when the anticoagulant is delivered to the distal end of the arterial blood circuit 1 and / or the distal end of the venous blood circuit 2 by the first operation of the blood pump, and the patient is punctured at the distal end of the arterial blood circuit 1 and the distal end of the venous blood circuit 2, the blood pump 4 is operated by providing a second drive signal to the blood pump 4 to perform a second operation. The effect of this configuration is to reduce the amount of pre-filled fluid (normal saline) applied to the patient along with the anticoagulant before blood purification treatment.

[0080] According to a second aspect of the invention, the blood purification device according to the first aspect further includes: a first solenoid valve (clamping device K1) configured to open and close the end of the arterial blood circuit 1; a second solenoid valve (clamping device K2) configured to open and close the end of the venous blood circuit 2; and a third solenoid valve (clamping device K3) configured to open and close a supply line through which dialysate is supplied. The control unit 9 is configured to perform the following process: opening the first and second solenoid valves before administering anticoagulant; closing the first and second solenoid valves after the anticoagulant has been delivered to the distal end of the arterial blood circuit 1 and / or the distal end of the venous blood circuit 2; and closing the third solenoid valve. The effect of this aspect is that, by controlling the solenoid valves, anticoagulant can be administered to the patient before blood purification treatment.

[0081] According to a third aspect of the invention, in the blood purification device according to the second aspect, when the anticoagulant is delivered to the distal end of the venous blood circuit 2 by the first operation of the blood pump 4 and the patient is punctured at the distal end of both the arterial blood circuit 1 and the venous blood circuit 2, the second solenoid valve (clamping device K2) and the third solenoid valve (clamping device K3) are opened, while the first solenoid valve (clamping device K1) is closed. The effect of this aspect is that, by controlling the solenoid valves, the anticoagulant can be applied from the distal end of the venous blood circuit 2.

[0082] According to a fourth aspect of the invention, in the blood purification device according to the second aspect, when the anticoagulant is delivered to the distal end of the arterial blood circuit 1 by the first operation of the blood pump 4 and the patient is punctured at the distal end of the arterial blood circuit 1 and the distal end of the venous blood circuit 2, the first solenoid valve (clamping device K1) and the third solenoid valve (clamping device K3) are opened as needed, while the second solenoid valve (clamping device K2) is closed. The effect of this aspect is that, by controlling the solenoid valves, the anticoagulant can be applied from the distal end of the arterial blood circuit 1.

[0083] According to a fifth aspect of the invention, in the blood purification apparatus according to the fourth aspect, a pressure accumulation step and a reverse rotation blood pump 4 step are repeatedly performed. The pressure accumulation step is performed by the normal rotation of the blood pump 4, while the first solenoid valve (clamping device K1) and the second solenoid valve (clamping device K2) are closed and the third solenoid valve (clamping device K3) is open. Simultaneously, the first solenoid valve (clamping device K1) is open and the second solenoid valve (clamping device K2) and the third solenoid valve (clamping device K3) are closed during the reverse rotation blood pump step. The effect of this aspect is that an anticoagulant can be applied through pressure accumulation.

[0084] According to a sixth aspect of the present invention, in the first aspect, the control unit 9 is configured to perform a standby process until a predetermined time expires after the second operation of the blood pump 4. The advantage of this aspect is that a predetermined standby time can be achieved after the application of an anticoagulant.

[0085] According to a seventh aspect of the present invention, in the blood purification apparatus according to the first aspect, with the distal ends of the arterial blood circuit and the distal ends of the venous blood circuit interconnected to form a closed circuit, the closed circuit filled with pre-filling fluid, and an anticoagulant injected into the blood circuit by activating the injection pump, the control unit causes the blood pump to perform a first operation. The advantage of this aspect is that the first operation can be performed while maintaining the closed circuit formed in the pre-filling step.

[0086] According to an eighth aspect of the present invention, a processing method is provided, executed by a control unit 9 included in a blood purification device, wherein the control unit 9 is configured to control a blood pump 4 and an injection pump 5, the blood pump 4 being configured to circulate blood in a blood circuit for extracorporeal circulation, and the injection pump 5 being configured to inject an anticoagulant into a predetermined location. The processing method includes: activating the injection pump 5 by providing a drive signal to the injection pump 5 while the blood circuit is filled with pre-filled fluid; performing a first operation by providing a first drive signal to the blood pump 4 while the anticoagulant is injected into the blood circuit by activating the injection pump 5; and performing a second operation by providing a second drive signal to the blood pump 4 while the anticoagulant is delivered to the distal end of an arterial blood circuit 1 and / or the distal end of a venous blood circuit 2 by the first operation of the blood pump 4 and the patient is punctured at the distal end of the arterial blood circuit 1 and the distal end of the venous blood circuit 2. The effect of this formulation is that it reduces the amount of pre-filled fluid (normal saline) that is applied to the patient along with the anticoagulant before blood purification treatment.

[0087] According to a ninth aspect of the present invention, a program is provided for a control unit 9 included in a blood purification device, wherein the control unit 9 is configured to control a blood pump 4 and an injection pump 5, the blood pump 4 being configured to circulate blood in a blood circuit for extracorporeal circulation, and the injection pump 5 being configured to inject an anticoagulant into a predetermined location. The program is configured to: activate the injection pump 5 by providing a drive signal while the blood circuit is filled with pre-filled fluid; while the anticoagulant is injected into the blood circuit by activating the injection pump 5, cause the blood pump 4 to perform a first operation by providing a first drive signal; and while the anticoagulant is delivered to the distal end of the arterial blood circuit 1 and / or the distal end of the venous blood circuit 2 by the first operation of the blood pump 4 and the patient is punctured at the distal end of the arterial blood circuit 1 and the distal end of the venous blood circuit 2, provide a second drive signal to the blood pump 4. The effect of this aspect is that it reduces the amount of pre-filled fluid (physiological saline) applied to the patient along with the anticoagulant before blood purification treatment.

[0088] The storage medium can store a program included in the control unit 9 of the blood purification device, wherein the control unit 9 is configured to control the blood pump 4 and the injection pump 5, the blood pump 4 is configured to cause blood flow in the blood circuit to perform extracorporeal circulation, and the injection pump 5 is configured to inject anticoagulant into a predetermined location. The program is configured to: cause the control unit 9 to start the injection pump 5 by providing a drive signal when the blood circuit is filled with pre-filled fluid; cause the blood pump 4 to perform a first operation by providing a first drive signal when the anticoagulant is injected into the blood circuit by starting the injection pump 5; and cause the blood pump 4 to perform a second drive signal when the anticoagulant is delivered to the distal end of the arterial blood circuit 1 and / or the distal end of the venous blood circuit 2 by the first operation of the blood pump 4 and the patient is punctured at the distal end of the arterial blood circuit 1 and the distal end of the venous blood circuit 2.

[0089] Industrial applicability

[0090] This invention is also applicable to any blood purification device with different appearance, additional functions, etc., as long as the blood purification device is equivalent to the blood purification device conceived in this invention.

[0091] List of reference numerals

[0092] 1. Arterial blood circuit

[0093] 1a connector

[0094] 2. Venous blood circuit

[0095] 2a connector

[0096] 3. Dialyzer (blood purification device)

[0097] 4. Blood pump

[0098] 5. Injection Pump

[0099] 6. Air trap chamber

[0100] 7 Containers

[0101] 8 Dialysis apparatus

[0102] 9. Control Department

[0103] M syringe

[0104] H-heparin (anticoagulant)

[0105] Clamping devices K1 to K3.

Claims

1. A blood purification device configured to purify a patient's blood by circulating blood outside the body through a blood circuit and a blood purifier, the blood circuit including an arterial blood circuit and a venous blood circuit, the blood purification device comprising: A blood pump configured to circulate blood in the blood circuit for extracorporeal circulation; An injection pump configured to inject the anticoagulant into a predetermined location; and The control unit is configured to control the blood pump and the infusion pump. The control unit is configured to: activate the injection pump by providing a drive signal when the blood circuit is filled with pre-filled fluid; activate the injection pump to inject anticoagulant into the blood circuit, and activate the injection pump to perform a first operation by providing a first drive signal to the blood pump; and activate the blood pump to deliver anticoagulant to the distal end of the arterial blood circuit and / or the distal end of the venous blood circuit, and perform a second drive signal to the blood pump when the first operation of the blood pump delivers anticoagulant to the distal end of the arterial blood circuit and / or the distal end of the venous blood circuit and the patient is punctured at the distal end of the arterial blood circuit and the distal end of the venous blood circuit.

2. The blood purification device according to claim 1, further comprising: A first solenoid valve is configured to open and close the end of the arterial blood circuit; A second solenoid valve is configured to open and close the end of the venous blood circuit; The third solenoid valve is configured to open and close the supply line through which dialysate is supplied. The control unit is configured as follows: Perform the following procedure: before delivering the anticoagulant, open the first solenoid valve and the second solenoid valve; after the anticoagulant has been delivered to the distal end of the arterial blood circuit and / or the distal end of the venous blood circuit, close the first solenoid valve and the second solenoid valve; and close the third solenoid valve.

3. The blood purification device according to claim 2, wherein, While the blood pump delivers anticoagulant to the distal end of the venous blood circuit during its first operation and the patient is punctured at the distal end of both the arterial and venous blood circuits, the second and third solenoid valves open, while the first solenoid valve closes.

4. The blood purification device according to claim 2, wherein, While the blood pump delivers anticoagulant to the distal end of the arterial blood circuit during its first operation and the patient is punctured at the distal end of both the arterial and venous blood circuits, the first and third solenoid valves open as needed, while the second solenoid valve closes.

5. The blood purification device according to claim 4, wherein, The pressure accumulation step and the reverse rotation of the blood pump are repeated. The pressure accumulation step is performed by the normal rotation of the blood pump, while the first solenoid valve and the second solenoid valve are closed and the third solenoid valve is open. The reverse rotation of the blood pump is performed while the first solenoid valve is open and the second solenoid valve and the third solenoid valve are closed.

6. The blood purification device according to claim 1, wherein, The control unit is configured to perform a standby process until a predetermined time expires after the second operation of the blood pump.

7. The blood purification device according to claim 1, wherein, With the distal ends of the arterial blood circuit and the distal ends of the venous blood circuit interconnected to form a closed circuit, the closed circuit filled with pre-filled fluid, and the anticoagulant injected into the blood circuit by starting the injection pump, the control unit causes the blood pump to perform the first operation.

8. A processing method executed by a control unit included in a blood purification device, wherein, The control unit is configured to control a blood pump and an injection pump. The blood pump is configured to circulate blood in the blood circuit for extracorporeal circulation, and the injection pump is configured to inject an anticoagulant into a predetermined location. The processing method includes: The step of activating the injection pump by providing a drive signal to the injection pump while the blood circuit is filled with pre-filled fluid; In the state where the anticoagulant is injected into the blood circuit by activating the injection pump, the step of causing the blood pump to perform a first operation by providing a first drive signal to the blood pump; and The step of delivering an anticoagulant to the distal end of the arterial blood circuit and / or the distal end of the venous blood circuit through the first operation of the blood pump, and with the patient having a puncture at the distal end of the arterial blood circuit and the distal end of the venous blood circuit, causing the blood pump to perform a second operation by providing a second drive signal to the blood pump.

9. A procedure for a control unit included in a blood purification device, wherein, The control unit is configured to control a blood pump and an injection pump. The blood pump is configured to circulate blood in the blood circuit for extracorporeal circulation, and the injection pump is configured to inject anticoagulant into a predetermined location. The program is configured to: activate the injection pump by providing a drive signal when the blood circuit is filled with pre-filled fluid; activate the injection pump to inject anticoagulant into the blood circuit, and activate the injection pump to perform a first operation by providing a first drive signal to the blood pump; and activate the blood pump to deliver anticoagulant to the distal end of the arterial blood circuit and / or the distal end of the venous blood circuit, and the patient is punctured at the distal end of the arterial blood circuit and the distal end of the venous blood circuit, and activate the first operation of the blood pump to deliver anticoagulant to the distal end of the arterial blood circuit and / or the distal end of the venous blood circuit, and activate the blood pump to provide a second drive signal.

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