Blood purification device

The blood purification device addresses the issue of excessive priming fluid administration by using a control unit to manage the flow of anticoagulant and priming fluid, reducing fluid overload and enhancing coagulation inhibition in patients.

WO2025075080A1PCT designated stage expired Publication Date: 2025-04-10NIKKISO CO LTD
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Patent Information

Application Number
PCT/JP2024/035417
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-10-06
Filing Date
2024-10-03
Publication Date
2025-04-10

AI Technical Summary

Technical Problem

Conventional blood purification devices administer an excessive amount of priming fluid along with the anticoagulant, which is undesirable for patients with fluid overload before blood purification treatment.

Method used

The blood purification device includes a blood pump, an injection pump, and a control unit that manages the flow of anticoagulant and priming fluid. When the blood circuit is filled with priming fluid, the control unit drives the injection pump to inject anticoagulant and then uses the blood pump to transfer the anticoagulant to the tips of the arterial and venous blood circuits, reducing the amount of priming fluid administered.

Benefits of technology

This approach reduces the amount of priming fluid administered with the anticoagulant, minimizing fluid overload in patients and enhancing the effectiveness of blood coagulation inhibition during blood purification treatment.

✦ Generated by Eureka AI based on patent content.

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Abstract

Provided is a blood purification device able to reduce the amount of priming solution administered along with anticoagulant when the anticoagulant is administered to a patient before a blood purification therapy. This blood purification device comprises a control unit for controlling a blood pump 4 and an infusion pump 5, and is configured so that the control unit 9: provides a drive signal to the infusion pump 5 and causes the infusion pump 5 to be driven in a state where a blood circuit has been filled with a priming solution; provides a first drive signal to the blood pump 4 and causes the blood pump 4 to perform first driving in a state where due to the driving of the infusion pump 5 the blood circuit has been infused with anticoagulant; and provides a second drive signal to the blood pump 4 in a state where due to first driving of the blood pump 4 the anticoagulant has been transferred to a distal end of an arterial-side blood circuit 1 and / or a distal end of a venous-side blood circuit 2 and the distal end of the arterial-side blood circuit 1 and the distal end of the venous-side blood circuit 2 have been used to puncture a patient.
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Description

Blood purification device

[0001] The present invention relates to a blood purification apparatus that purifies a patient's blood by extracorporeally circulating the blood through a blood circuit having an arterial blood circuit and a venous blood circuit and a blood purifier.

[0002] A dialysis machine as a blood purification device used in dialysis treatment or the like typically comprises a piping section having a dialysate inlet line for introducing dialysate into the blood purifier and a drainage discharge line for discharging drainage from the blood purifier, and a fluid delivery section for delivering the dialysate and drainage in the piping section. The dialysis machine is configured by connecting a blood circuit for circulating the patient's blood extracorporeally to the blood purifier, and performs dialysis treatment (blood purification treatment) using the blood purifier while circulating the patient's blood extracorporeally through the blood circuit.

[0003] On the other hand, when a patient's blood is circulated extracorporeally in blood purification therapy, an anticoagulant must be administered to the patient in advance to prevent blood coagulation. Therefore, in order for the anticoagulant to fully exert its anticoagulant effect, blood purification therapy must be performed a predetermined time (e.g., about 3 to 5 minutes) after the anticoagulant is administered to the patient. For this reason, as disclosed in Patent Document 1, a blood purification device has been proposed in which an anticoagulant is injected into a blood circuit, and then the anticoagulant is administered into the patient's body together with a priming solution, and blood purification therapy is performed after a predetermined time has elapsed.

[0004] Japanese Patent Application Laid-Open No. 2020-14851

[0005] However, in the above-mentioned conventional blood purification devices, when an anticoagulant is administered into a patient's body, for example, if there is a relatively long flow path from the anticoagulant injection point to the patient, an excessive amount of priming solution corresponding to the priming volume of the flow path is administered into the patient's body along with the anticoagulant. Because patients before blood purification treatment are usually in a state of fluid overload, administering an excessive amount of priming solution to such a patient in a fluid overload state is undesirable.

[0006] The present invention has been made in consideration of the above circumstances, and aims to provide a blood purification device that can reduce the amount of priming solution administered together with an anticoagulant when administering the anticoagulant to a patient before blood purification treatment.

[0007] A blood purification device according to one embodiment of the present invention is a blood purification device that purifies a patient's blood by extracorporeally circulating it through a blood circuit having an arterial blood circuit and a venous blood circuit, and the blood is equipped with a blood pump that circulates the blood in the blood circuit by moving it through the extracorporeal circulation, an infusion pump that injects an anticoagulant into a predetermined site, and a control unit that controls the blood pump and the infusion pump, wherein the control unit is configured to supply a drive signal to the infusion pump to drive the infusion pump when the blood circuit is filled with a priming solution, supply a first drive signal to the blood pump to drive the blood pump in a first state when the anticoagulant is injected into the blood circuit by the driving of the infusion pump, and supply a second drive signal to the blood pump when the anticoagulant is transported to a tip of the arterial blood circuit and / or a tip of the venous blood circuit by the first driving of the blood pump, and when the tip of the arterial blood circuit and the tip of the venous blood circuit are punctured into the patient.

[0008] According to the present invention, when the blood circuit is filled with priming solution, a drive signal is supplied to the infusion pump to drive the infusion pump, and when an anticoagulant is injected into the blood circuit by driving the infusion pump, a first drive signal is supplied to the blood pump to drive the blood pump in a first manner, and when the anticoagulant is transported to the tip of the arterial blood circuit and / or the tip of the venous blood circuit by the first drive of the blood pump, and when the tip of the arterial blood circuit and the tip of the venous blood circuit are punctured into the patient, a second drive signal is supplied to the blood pump, thereby making it possible to reduce the amount of priming solution administered together with the anticoagulant when administering the anticoagulant to a patient before blood purification treatment.

[0009] Schematic diagram showing a blood purification device according to an embodiment of the present invention. Flowchart showing the overall process of the blood purification device. Flowchart showing the administration preparation process of the blood purification device. Schematic diagram showing the priming process of the blood purification device. Schematic diagram showing the injection process of the blood purification device. Schematic diagram showing the transfer process of the blood purification device (transfer only to the tip of the venous blood circuit). Schematic diagram showing the attachment of a puncture needle to the blood purification device. Schematic diagram showing the administration process of the blood purification device. Schematic diagram showing the blood purification treatment process of the blood purification device. Block diagram showing the configuration around the control unit of the blood purification device. Schematic diagram showing the state in which the transfer process of the blood purification device (transfer only to the tip of the arterial blood circuit) is being performed (transfer to the tips of the arterial blood circuit and the venous blood circuit) is being performed. Time chart showing the operation of the components around the control unit of the blood purification device (when transferring only to the tip of the venous blood circuit). Time chart showing the operation of the components around the control unit of the blood purification device (when transferring only to the tip of the arterial blood circuit). Time chart showing the operation of the components around the control unit of the blood purification device (when transferring to the tips of the arterial blood circuit and the venous blood circuit). Schematic diagram showing a blood purification device according to another embodiment of the present invention.

[0010] Hereinafter, an embodiment of the present invention will be described in detail with reference to the drawings. The blood purification device according to this embodiment circulates a patient's blood extracorporeally through a blood circuit having an arterial blood circuit and a venous blood circuit and a blood purifier, and purifies the blood. As shown in Figure 1, the blood purification device comprises a blood circuit having an arterial blood circuit 1 and a venous blood circuit 2, a dialyzer 3 as a blood purifier, a blood pump 4, an infusion pump 5, a dialysis device main body 8 capable of supplying dialysate to the dialyzer 3, and a control unit 9.

[0011] The arterial blood circuit 1 has a connector 1a connected to its tip, through which an arterial puncture needle a (see Figures 7 and 8) can be connected, and a peristaltic blood pump 4 is disposed midway. The blood pump 4 is a pump disposed at a predetermined position in the arterial blood circuit 1, and is used to circulate blood and priming solution within the blood circuit when driven.

[0012] On the other hand, the venous blood circuit 2 has a connector 2a connected to its tip, through which a venous puncture needle b (see Figures 7 and 8) can be connected, and an air trap chamber 6 is connected midway. The air trap chamber 6 is a chamber connected to a predetermined position on the venous blood circuit 2, and serves to trap and remove air contained in the blood circulating extracorporeally.

[0013] Clamping means K1 and K2 consisting of electromagnetic valves are provided at the tip of the arterial blood circuit 1 and the tip of the venous blood circuit 2, respectively. By opening the clamping means K1 and K2, the flow path at the tip of the arterial blood circuit 1 or the venous blood circuit 2 is opened, and by closing the clamping means K1 and K2, the flow path at the tip of the arterial blood circuit 1 or the venous blood circuit 2 is closed.

[0014] The dialyzer 3 (blood purifier) ​​has a housing formed with a blood inlet 3a (blood inlet port), a blood outlet 3b (blood outlet port), a dialysate inlet 3c (dialysate inlet port), and a dialysate outlet 3d (dialysate outlet port), of which the blood inlet 3a is connected to the arterial blood circuit 1 and the blood outlet 3b is connected to the venous blood circuit 2. The dialysate inlet 3c and the dialysate outlet 3d are connected to a dialysate introduction line L1 and a effluent discharge line L2, respectively.

[0015] The dialyzer 3 contains a plurality of hollow fiber membranes (not shown), which constitute a blood purification membrane for purifying blood. The hollow fiber membranes that constitute the blood purification membrane have many minute pores formed through their outer and inner surfaces, allowing impurities in the blood to pass through the hollow fiber membranes into the dialysis fluid and be purified.

[0016] The dialysis device main body 8 is provided with a dialysate inlet line L1 for introducing dialysate into the dialyzer 3 and a waste fluid discharge line L2 for discharging waste fluid from the dialyzer 3. One end of the dialysate inlet line L1 is connected to the dialyzer 3 (dialysate inlet 3c), and the other end is connected to a dialysate preparation means (not shown) for preparing dialysate of a predetermined concentration, so that dialysate of a predetermined concentration can be introduced into the dialyzer 3.

[0017] One end of the effluent discharge line L2 is connected to the dialyzer 3 (dialysis fluid outlet 3d), and the other end is connected to a drainage means (not shown), so that the dialysate supplied from the dialysate supply device passes through the dialysate inlet line L1 to the dialyzer 3, and then the drainage from the dialyzer 3 is sent to the drainage means through the effluent discharge line L2. The dialysis device main body 8 is provided with a fluid supply pump for flowing the dialysate and drainage fluid, and a water removal pump (not shown) for removing water from the patient's blood flowing through the dialyzer 3.

[0018] However, when the blood pump 4 is driven with the arterial puncture needle a connected to the tip of the arterial blood circuit 1 and the venous puncture needle b connected to the tip of the venous blood circuit 2 inserted into the patient, the patient's blood passes through the arterial blood circuit 1 to the dialyzer 3, where it is subjected to blood purification treatment, and then returns to the patient's body through the venous blood circuit 2. In this way, the patient's blood can be purified by the dialyzer 3 while being circulated extracorporeally through the blood circuit.

[0019] In this embodiment, a saline line L3 is connected to the arterial blood circuit 1 at a position between the connector 1a and the location of the blood pump 4, and a storage container 7 containing a predetermined amount of priming solution (physiological saline) is connected to the tip of the saline line L3. A clamping means K3 consisting of an electromagnetic valve is disposed on the saline line L3, and by opening the clamping means K3 to open the saline line L3, the priming solution in the storage container 7 can be supplied to the blood circuit, and by closing the clamping means K3 to block the saline line L3, the supply of priming solution to the blood circuit can be stopped.

[0020] Furthermore, in the arterial blood circuit 1 according to this embodiment, an anticoagulant injection line L4 is connected between the location of the blood pump 4 and the connection location of the dialyzer 3, and a syringe M containing a predetermined amount of anticoagulant (heparin H in this embodiment) is connected to the tip of the line L4. The syringe M is attached to an injection pump 5 arranged in the dialysis device main body 8, and a pusher (not shown) provided in the injection pump 5 slides the plunger of the syringe M, thereby enabling the predetermined amount of anticoagulant contained therein to be injected.

[0021] Heparin H as an anticoagulant consists of, for example, unfractionated heparin and low molecular weight heparin, and is initially administered before blood purification treatment (before dialysis treatment) and is continuously administered (continuously administered) as needed during the blood purification treatment process. Note that other types of anticoagulants that can exert a coagulation inhibitory effect may be injected and administered instead of heparin.

[0022] In this embodiment, the volume between the connection point of the anticoagulant injection line L4 and the tip of the arterial blood circuit 1 is 45.1 ml, and the flow rate of the blood pump 4 is 8.696 ml / revolution. Based on this assumption, in the transfer step described below, heparin H can be transferred from the anticoagulant injection line L4 to the tip of the venous blood circuit 2 by rotating the blood pump 4 reversely approximately six times (52.2 ml). In the administration step described below, heparin H can be administered to the patient from the venous blood circuit 2 by rotating the blood pump 4 forward approximately two times (17.4 ml) after connecting to the patient. The volume of the blood circuit differs depending on the model of the device, so it must be confirmed and set in the device in advance. Adjusting the required rotation speed in the transfer and administration steps requires experimental confirmation of the extent to which heparin H diffuses during the transfer step.

[0023] The control unit 9 is composed of a microcomputer or the like (specifically, the microcomputer 9a shown in FIG. 10) disposed in the dialysis device main body 8, and is electrically connected to the blood pump 4, the infusion pump 5, and the clamping means (K1 to K3), and controls the driving of the blood pump 4 and the infusion pump 5 and the operation of the clamping means (K1 to K3), thereby enabling the execution of a priming step in which the blood circuit is filled with a priming solution, and a blood purification treatment step in which the patient's blood is circulated extracorporeally through the blood circuit and purified by the dialyzer 3.

[0024] Here, the control unit 9 according to this embodiment is capable of sequentially executing the following steps after the priming step: an injection step in which the injection pump 5 is driven to inject an anticoagulant (heparin H) into the blood circuit; a transfer step in which the blood pump 4 is driven to transfer the heparin H injected in the injection step to the tip of the arterial blood circuit 1 and the tip of the venous blood circuit 2; an administration step in which the blood pump 4 is driven while the tip of the arterial blood circuit 1 and / or the tip of the venous blood circuit 2 is punctured into the patient, and the heparin H transferred in the transfer step is administered to the patient; and a waiting step in which the control unit waits until a predetermined time has elapsed after the administration step.

[0025] Next, the control by the control unit 9 according to this embodiment will be described with reference to the flowcharts of Figures 2 and 3. First, as shown in Figure 4, the connector 1a at the tip of the arterial blood circuit 1 and the connector 2a at the tip of the venous blood circuit 2 are connected to form a closed circuit. Then, the clamping device K3 is opened and the blood pump 4 is driven (normally driven) to introduce a priming solution (physiological saline) from the storage container 7 into the blood circuit to fill it. This priming step S1 is performed. In this priming step S1, the priming solution from the storage container 7 circulates within the closed circuit formed by the arterial blood circuit 1 and the venous blood circuit 2, and is discharged to the outside via an overflow line La extending from the top of the air trap chamber 6, thereby filling the closed circuit. However, the priming method is not limited to this, and various priming methods may be used in the priming step.

[0026] After the priming step S1, the process proceeds to the administration preparation step S2. In the administration preparation step S2, as shown in Fig. 3, in S201, the first and second solenoid valves (clamping means K1, K2) are opened and the third solenoid valve (clamping means K3) is closed. In S202, a drive signal is sent to the actuator P2 of the infusion pump 5 to drive the infusion pump 5 (Fig. 5). Thereafter, in S203, a first drive signal is sent to the actuator P1 of the blood pump 4, which drives the blood pump 4 to transfer heparin H (transfer step), as shown in Fig. 6. Then, in S204, the first and second solenoid valves (clamping means K1, K2) are closed while the third solenoid valve (clamping means K3) is maintained closed (see Fig. 7). In S205, it is determined whether a signal indicating completion of puncture of the distal end of the arterial blood circuit 1 and the distal end of the venous blood circuit 2 has been received.

[0027] 8 , with the arterial puncture needle a and the venous puncture needle b inserted into the patient, the blood pump 4 is driven in the forward direction while the clamp K1 is closed, the clamp K2 is open, and the clamp K3 is open. Thus, heparin H at the tip of the venous blood circuit 2 (near the connector 2 a) is administered into the patient's body via the venous puncture needle b. The amount of heparin H administered in the administration step S3 can be estimated based on the rotation speed of the blood pump 4.

[0028] After the administration step S3, a waiting step S4 is executed, in which the operation of the blood pump 4 and the infusion pump 5 is stopped and the system waits for a predetermined time (for example, about 3 to 5 minutes) to elapse. By waiting for the predetermined time to elapse in the waiting step S4, the heparin H administered into the patient's body can be activated to sufficiently enhance the blood coagulation inhibitory effect, and blood coagulation can be inhibited when the patient's blood is circulated extracorporeally in the subsequent blood purification treatment step S5.

[0029] After the standby step S4, as shown in Fig. 9, the blood pump 4 is driven in the normal direction while the arterial needle a and the venous needle b are kept inserted into the patient, and the dialysate is introduced into the dialyzer 3 via the dialysate inlet line L1 while the effluent is discharged via the effluent outlet line L2. This executes the blood purification treatment step S5, in which the patient's blood is purified in the dialyzer 3 while being circulated extracorporeally through the blood circuit.

[0030] Although the transfer step according to this embodiment transfers heparin H only to the tip of the venous blood circuit 2 as shown in FIG. 6, it may alternatively be one in which heparin H is transferred only to the tip of the arterial blood circuit 1 as shown in FIG. 11, or one in which heparin H is transferred to both the tip of the arterial blood circuit 1 and the tip of the venous blood circuit 2 as shown in FIG. 12.

[0031] Next, the peripheral configuration of the control unit 9 according to this embodiment and the control performed by this peripheral configuration will be described with reference to the block diagram of Fig. 10. As shown in Fig. 10, the control unit 9 according to this embodiment has a microcomputer 9a, which is electrically connected to a touch panel 10a of the input unit 10 so as to receive input signals from the touch panel 10a. The microcomputer 9a is also connected to a drive unit 11 which has an actuator P1 of the blood pump 4, an actuator P2 of the infusion pump 5, a drive coil J1 of the clamping means K1 (first solenoid valve), a drive coil J2 of the clamping means K2 (second solenoid valve), and a drive coil J3 of the clamping means K3 (third solenoid valve).

[0032] In this embodiment, when the blood circuit is filled with priming solution, a drive signal is supplied to the actuator P2 of the infusion pump 5 to drive the infusion pump 5, and when an anticoagulant is injected into the blood circuit by driving the infusion pump 5, a first drive signal is supplied to the actuator P1 of the blood pump 4 to drive the blood pump 4 in the first mode, and when the anticoagulant is transported to the tip of the arterial blood circuit 1 or the tip of the venous blood circuit 2 by the first drive of the blood pump 4, and when the tip of the arterial blood circuit 1 and the tip of the venous blood circuit 2 are punctured into the patient, a second drive signal is supplied to the actuator P1 of the blood pump 4 to perform a process for secondly driving the blood pump 4.

[0033] Furthermore, in this embodiment, a first solenoid valve (clamping means K1) that opens and closes an end of the arterial blood circuit 1, a second solenoid valve (clamping means K2) that opens and closes an end of the venous blood circuit 2, and a third solenoid valve (clamping means K3) that opens and closes a supply line for supplying the dialysis fluid are provided. The microcomputer 9a of the control unit 9 is configured to execute processing to open the first solenoid valve and the second solenoid valve and close the third solenoid valve before the anticoagulant is injected, and to close the first solenoid valve and the second solenoid valve and close the third solenoid valve after the anticoagulant has been transported to the tip of the arterial blood circuit 1 or the tip of the venous blood circuit 2.

[0034] Next, the peripheral configuration of the control unit 9 according to this embodiment and the control performed by the peripheral configuration will be described with reference to the timing chart in FIG. 13 . This timing chart assumes the case where heparin H is delivered only to the distal end of the venous blood circuit 2 (see FIG. 6 ). During the priming step (600(s)), the blood pump actuator P1 is turned on (a drive signal for forward rotation is present) to drive the blood pump 4 in the forward direction, the infusion pump actuator P2 is turned off (no drive signal is present) to stop the infusion pump 5, and the clamp solenoid valve drive coils J1, J2, and J3 are turned on (drive signals are present) to open the flow paths. Note that, in this embodiment, the clamp solenoid valves (J1-J3) are closed in their initial state (no drive signal is present), but they may be open in their initial state.

[0035] In the injection step (60(s)), the blood pump actuator P1 is turned off (no drive signal) to stop the blood pump 4, the injection pump actuator P2 is turned on (drive signal present) to drive the injection pump 5, the clamp solenoid valve drive coil J1 and the clamp solenoid valve drive coil J2 are turned on (drive signal present) to open the flow path, and the clamp solenoid valve drive coil J3 is turned off (no drive signal) to close the flow path.

[0036] In the transfer step (60(s)), the blood pump actuator P1 is turned on (reverse rotation drive signal present) to drive the blood pump 4 in reverse rotation, the injection pump actuator P2 is turned off (no drive signal present) to stop the injection pump 5, the clamp solenoid valve drive coil J1 and the clamp solenoid valve drive coil J2 are turned on (drive signal present) to open the flow path, and the clamp solenoid valve drive coil J3 is turned off (no drive signal present) to close the flow path.

[0037] During the subsequent puncture operation, the blood pump actuator P1 is turned off (no drive signal) to stop the blood pump 4, the injection pump actuator P2 is turned off (no drive signal) to stop the injection pump 5, and the clamp solenoid valve drive coil J1, the clamp solenoid valve drive coil J2, and the clamp solenoid valve drive coil J3 are turned off (no drive signal) to block the flow path.

[0038] In the venous administration step (60(s)), the blood pump actuator P1 is turned on (a drive signal for forward rotation is present) to drive the blood pump 4 in the forward direction, the infusion pump actuator P2 is turned off (no drive signal is present) to stop the infusion pump 5, the clamp solenoid valve drive coil J2 and the clamp solenoid valve drive coil J3 are turned on (drive signal is present) to open the flow path, and the clamp solenoid valve drive coil J1 is turned off (no drive signal) to close the flow path.

[0039] In the standby process (600 (s)), the blood pump actuator P1 is turned off (no drive signal) to stop the blood pump 4, the infusion pump actuator P2 is turned off (no drive signal) to stop the infusion pump 5, and the clamp solenoid valve drive coil J1, the clamp solenoid valve drive coil J2, and the clamp solenoid valve drive coil J3 are turned off (no drive signal) to block the flow path.

[0040] At the start of the blood purification treatment process (4(h)), the blood pump actuator P1 is turned on (a drive signal for forward rotation is present) to drive the blood pump 4 in the forward direction, the infusion pump actuator P2 is turned off (no drive signal) to stop the infusion pump 5, the clamp solenoid valve drive coil J1 and the clamp solenoid valve drive coil J2 are turned on (drive signal is present) to open the flow path, and the clamp solenoid valve drive coil J3 is turned off (no drive signal) to close the flow path.

[0041] Next, the peripheral configuration of the control unit 9 according to this embodiment and the control performed by the peripheral configuration will be described with reference to the timing chart in Fig. 14. This timing chart assumes the case where heparin H is delivered only to the tip of the arterial blood circuit 1 (see Fig. 11). The priming step, injection step, delivery step, puncturing step, waiting step, and treatment step are the same as those when heparin H is delivered only to the tip of the venous blood circuit 2.

[0042] In the arterial administration step (1(s), 2(s)), the following states are repeated a required number of times: the blood pump actuator P1 is turned on (a drive signal for forward rotation is present) to drive the blood pump 4 in forward rotation; the infusion pump actuator P2 is turned off (no drive signal) to stop the infusion pump 5; the clamping solenoid valve drive coil J3 is turned on (a drive signal is present) to open the flow path; the clamping solenoid valve drive coil J1 and the clamping solenoid valve drive coil J2 are turned off (no drive signal) to close the flow path; and the blood pump actuator P1 is turned on (a drive signal for reverse rotation) to drive the blood pump 4 in reverse rotation; the infusion pump actuator P2 is turned off (no drive signal) to stop the infusion pump 5; the clamping solenoid valve drive coil J1 is turned on (a drive signal is present) to open the flow path; and the clamping solenoid valve drive coil J2 and the clamping solenoid valve drive coil J3 are turned off (no drive signal) to close the flow path.

[0043] Next, the peripheral configuration of the control unit 9 according to this embodiment and the control performed by that peripheral configuration will be described with reference to the timing chart in Fig. 15. This timing chart assumes the case where heparin H is transferred to the tips of the arterial blood circuit 1 and the venous blood circuit 2 (see Fig. 12). The priming step, injection step, transfer step, puncturing step, waiting step, venous administration step, and treatment step are the same as when heparin H is transferred only to the tip of the venous blood circuit 2, and the arterial administration step is the same as when heparin H is transferred only to the tip of the arterial blood circuit 1.

[0044] According to this embodiment, after the priming step S1, the control unit 9 sequentially executes the following steps: an injection step in which the injection pump 5 is driven to inject an anticoagulant into the blood circuit; a transfer step in which the blood pump 4 is driven in a first drive to transfer the anticoagulant injected in the injection step to the tip of the arterial blood circuit 1 and the tip of the venous blood circuit 2; and an administration step S3 in which the blood pump 4 is driven in a second drive with the tip of the arterial blood circuit 1 and the tip of the venous blood circuit 2 kept inserted into the patient, thereby administering the anticoagulant transferred in the transfer step to the patient. Therefore, when an anticoagulant is administered to a patient before blood purification treatment, the amount of priming solution (physiological saline) administered together with the anticoagulant can be reduced.

[0045] In addition, by reducing the amount of priming solution administered, it is possible to suppress cardiac stress (preventing an increase in blood pressure) due to fluid overload.Furthermore, by increasing the blood coagulation inhibitory effect, it is possible to reduce the amount of heparin administered, which reduces the cost of anticoagulants (heparin) and reduces the side effects of anticoagulants (heparin).In the past, medical professionals measured the waiting time and waited until treatment began, but by having the device do this automatically, it is possible to reduce the effort required by medical professionals.

[0046] Furthermore, the control unit 9 according to this embodiment executes a waiting step in which it waits until a predetermined time has elapsed after the administration step, thereby activating the heparin H administered into the patient's body and sufficiently enhancing the blood coagulation inhibitory effect, and blood coagulation can be inhibited when the patient's blood is circulated extracorporeally in the subsequent blood purification treatment step S5.

[0047] Furthermore, in the priming step S1 according to the present embodiment, a closed circuit is formed by connecting the tip of the arterial blood circuit 1 and the tip of the venous blood circuit 2 to each other, and the closed circuit is filled with a priming solution (physiological saline solution). The closed circuit is maintained in the injecting step and the transferring step. Therefore, the injecting step and the transferring step can be performed by utilizing the closed circuit formed in the priming step S1.

[0048] Furthermore, in the transfer step according to this embodiment, the blood pump 4 is driven in the reverse direction to transfer the heparin H to the tip of the arterial blood circuit 1 and the tip of the venous blood circuit 2, so that the heparin H injected in the injection step can be prevented from passing through the dialyzer 3, and the heparin H can be reliably transferred to the tip of the arterial blood circuit 1 and the tip of the venous blood circuit 2.

[0049] In addition, in the administration step S3 according to this embodiment, the heparin H at the tip of the venous blood circuit 2 is administered to the patient by driving the blood pump 4 in the forward direction, and the heparin H at the tip of the arterial blood circuit 1 is administered to the patient by driving the blood pump 4 in the reverse direction. This makes it possible to reliably administer the heparin H at the tip of the venous blood circuit 2 and the heparin H at the tip of the arterial blood circuit 1 to the patient.

[0050] While the present embodiment has been described above, the present invention is not limited to this, and may be applied to a configuration in which, for example, as shown in Fig. 16, a supply line Lb is connected between the dialysate introduction line L1 and a predetermined portion of the arterial blood circuit 1 (in the figure, a position between the connector 1a and the portion where the blood pump 4 is disposed), and a clamping means K3 consisting of an electromagnetic valve is connected midway along the supply line Lb. In this case, the priming solution filled in the priming step becomes the dialysate supplied from the supply line Lb, and can be supplied to the blood circuit by opening the clamping means K3.

[0051] In addition, in the administration step S3, when heparin H has been transferred to the tip of the arterial blood circuit 1, the clamping means K2 is kept in a closed state and the blood pump 4 is driven in the forward direction to fill and pressurize the priming solution (physiological saline or dialysis solution) in the air trap chamber 6, and then the blood pump 4 is driven in the reverse direction to flow the pressurized priming solution toward the arterial blood circuit 1, and the heparin H at the tip of the arterial blood circuit 1 may be administered into the patient's body.

[0052] 14 and 15 , the control unit 9 can include a pressure accumulation step (1(s)) in which the blood pump 4 is driven in the normal direction while closing the flow path with the clamping device K2, thereby accumulating pressure between the positions of the blood pump 4 and the clamping device K2, and a step (2(s)) in which the blood pump 4 is driven in the reverse direction while maintaining closure of the flow path with the clamping device K2, thereby administering heparin H from the distal end of the arterial blood circuit 1. The pressure accumulation step is a step in which, under the control of the control unit 9, the clamping device K1 and the clamping device K2 are closed, the clamping device K3 is opened, and the blood pump 4 is driven in the normal direction, thereby increasing and accumulating pressure in the air trap chamber 6. This pressure accumulation step allows a predetermined amount of priming solution to be stored and secured when administering heparin H from the distal end of the arterial blood circuit 1. It is preferable to provide the air trap chamber 6 with a pressure sensor to detect and monitor the pressure during accumulation.

[0053] Furthermore, in the transfer step, heparin H may be transferred only to the tip of the arterial blood circuit 1 or only to the tip of the venous blood circuit 2, and then in the administration step S3, the blood pump 4 may be driven in either forward or reverse rotation to administer the heparin H at the tip of the arterial blood circuit 1 or the heparin H at the tip of the venous blood circuit 2 to the patient. In this case, the execution time of the administration step S3 can be shortened.

[0054] Furthermore, when heparin H is transferred to both the arterial blood circuit 1 and the venous blood circuit 2, the administration step S3 according to this embodiment is configured to administer heparin H to the patient from the tip of the venous blood circuit 2, and then administer heparin H to the patient from the tip of the arterial blood circuit 1. However, it may also be configured to administer heparin H to the patient from the tip of the arterial blood circuit 1, and then administer heparin H to the patient from the tip of the venous blood circuit 2, or to administer heparin H to the patient alternately from both the tip of the arterial blood circuit 1 and the tip of the venous blood circuit 2.

[0055] In a first embodiment of the present invention, a blood purification device circulates a patient's blood extracorporeally through a blood circuit having an arterial blood circuit 1 and a venous blood circuit 2 and a blood purifier to purify the blood. The blood purification device includes a blood pump 4 that circulates the blood extracorporeally by moving the blood in the blood circuit, an infusion pump 5 that injects an anticoagulant into a predetermined site, and a control unit 9 that controls the blood pump 4 and the infusion pump 5. The control unit 9 is configured to execute the following processes: when the blood circuit is filled with a priming solution, the control unit 9 supplies a drive signal to the infusion pump 5 to drive the infusion pump 5; when the infusion pump 5 has injected the anticoagulant into the blood circuit by driving it, the control unit 9 supplies a first drive signal to the blood pump 4 to drive it in a first state; when the first drive of the blood pump 4 transports the anticoagulant to the tip of the arterial blood circuit 1 or the tip of the venous blood circuit 2, and when the tip of the arterial blood circuit 1 or the tip of the venous blood circuit 2 is punctured in the patient, the control unit 9 executes the following processes: This has the effect of reducing the amount of priming solution (physiological saline solution) administered together with the anticoagulant when administering the anticoagulant to a patient before blood purification treatment.

[0056] A second embodiment of the present invention is a blood purification device according to the first embodiment, further comprising a first solenoid valve (clamping means K1) for opening and closing an end of the arterial blood circuit 1, a second solenoid valve (clamping means K2) for opening and closing an end of the venous blood circuit 2, and a third solenoid valve (clamping means K3) for opening and closing a supply line for supplying dialysate, and the control unit 9 is configured to execute a process of opening the first and second solenoid valves before the anticoagulant is transferred, and closing the first and second solenoid valves and closing the third solenoid valve after the anticoagulant has been transferred to the end of the arterial blood circuit 1 or the end of the venous blood circuit 2. This provides the advantage that when an anticoagulant is administered to a patient before blood purification therapy, the anticoagulant can be administered by controlling the solenoid valves.

[0057] A third embodiment of the present invention is a blood purification device in which, in the second embodiment, the anticoagulant is transported to the tip of the venous blood circuit 2 by the first drive of the blood pump 4, and the tips of the arterial blood circuit 1 and the venous blood circuit 2 are punctured into a patient, and the second solenoid valve (clamping means K2) and the third solenoid valve (clamping means K3) are opened and the first solenoid valve (clamping means K1) is closed. This provides the effect of enabling the anticoagulant to be administered from the tip of the venous blood circuit 2 by controlling the solenoid valves.

[0058] A fourth embodiment of the present invention is a blood purification device in which, in the second embodiment, the anticoagulant is transported to the tip of the arterial blood circuit 1 by the first drive of the blood pump 4, and the tips of the arterial blood circuit 1 and the venous blood circuit 2 are punctured into a patient, while the second solenoid valve (clamping means K2) is closed and the first solenoid valve (clamping means K1) and the third solenoid valve (clamping means K3) are appropriately opened. This provides the effect of enabling the anticoagulant to be administered from the tip of the arterial blood circuit 1 by controlling the solenoid valves.

[0059] A fifth embodiment of the present invention is a blood purification device that, in the fourth embodiment, repeatedly performs a pressure accumulation step of driving the blood pump 4 in the forward direction while keeping the first solenoid valve (clamping means K1) and the second solenoid valve (clamping means K2) in the closed state and the third solenoid valve (clamping means K3) in the open state to accumulate pressure, and a step of rotating the blood pump 4 in the reverse direction while keeping the first solenoid valve (clamping means K1) in the open state and the second solenoid valve (clamping means K2) and the third solenoid valve (clamping means K3) in the closed state. This allows pressure accumulation and administration of an anticoagulant.

[0060] In a sixth embodiment of the present invention, in the first embodiment, the control unit 9 is configured to execute processing to wait until a predetermined time has elapsed after the blood pump 4 has been driven in the first or second direction, so that the blood pump 4 can wait for a predetermined time after administering an anticoagulant.

[0061] A seventh embodiment of the present invention is a blood purification device according to the first embodiment, in which the end of the arterial blood circuit and the end of the venous blood circuit are connected to form a closed circuit, the priming solution is filled, and an anticoagulant is injected into the blood circuit by driving the infusion pump, and the control unit drives the blood pump in the first drive mode, thereby maintaining the closed circuit state formed in the priming step.

[0062] An eighth embodiment of the present invention is a processing method executed by the control unit 9 in a blood purification apparatus equipped with a blood pump 4 that circulates blood in a blood circuit extracorporeally and a control unit 9 that controls an infusion pump 5 that injects an anticoagulant into a predetermined site, the processing method including the steps of: supplying a drive signal to the infusion pump 5 to drive the infusion pump 5 when the blood circuit is filled with a priming solution; supplying a first drive signal to the blood pump 4 to drive the blood pump 4 in a first state when the anticoagulant is injected into the blood circuit by driving the infusion pump 5; and supplying a second drive signal to the blood pump 4 to drive the blood pump 4 in a second state when the anticoagulant is transported to the tip of the arterial blood circuit 1 or the tip of the venous blood circuit 2 by the first drive of the blood pump 4 and the tip of the arterial blood circuit 1 or the venous blood circuit 2 is punctured into the patient. This has the effect of reducing the amount of priming solution (physiological saline) administered together with the anticoagulant when the anticoagulant is administered to a patient before blood purification treatment.

[0063] A ninth embodiment of the present invention is a blood purification apparatus including a blood pump 4 for extracorporeally circulating blood in a blood circuit and a control unit 9 for controlling an infusion pump 5 for injecting an anticoagulant into a predetermined site. The control unit 9 is configured to: supply a drive signal to the infusion pump 5 to drive it when the blood circuit is filled with a priming solution; supply a first drive signal to the blood pump 4 to drive it in a first state when the infusion pump 5 has injected an anticoagulant into the blood circuit; and supply a second drive signal to the blood pump 4 when the first drive of the blood pump 4 transports the anticoagulant to the tip of the arterial blood circuit 1 or the tip of the venous blood circuit 2, and the tip of the arterial blood circuit 1 or the venous blood circuit 2 is inserted into the patient. This provides the advantage of reducing the amount of priming solution (physiological saline) administered together with the anticoagulant when the anticoagulant is administered to a patient before blood purification treatment.

[0064] In addition, in a blood purification device equipped with a blood pump 4 for extracorporeal circulation by causing blood in a blood circuit to flow, and a control unit 9 for controlling an infusion pump 5 for injecting an anticoagulant into a predetermined site, the control unit 9 may be a storage medium storing a program for causing the control unit 9 to function as follows: when the blood circuit is filled with a priming solution, supply a drive signal to the infusion pump 5 to drive the infusion pump 5; when the anticoagulant has been injected into the blood circuit by driving the infusion pump 5, supply a first drive signal to the blood pump 4 to drive it as a first drive; when the anticoagulant has been transported to the tip of the arterial blood circuit 1 or the tip of the venous blood circuit 2 by the first drive of the blood pump 4, and when the tip of the arterial blood circuit 1 and the tip of the venous blood circuit 2 are punctured into a patient, supply a second drive signal to the blood pump 4.

[0065] The present invention can be applied to blood purification devices having different external shapes or having additional functions, as long as they are equivalent to the spirit of the present invention.

[0066] REFERENCE SIGNS LIST 1 Arterial blood circuit 1a Connector 2 Venous blood circuit 2a Connector 3 Dialyzer (blood purifier) ​​4 Blood pump 5 Infusion pump 6 Air trap chamber 7 Storage container 8 Dialysis device body 9 Control unit M Syringe H Heparin (anticoagulant) K1 to K3 Clamping means

Claims

1. A blood purification device which purifies a patient's blood by circulating it extracorporeally through a blood circuit having an arterial blood circuit and a venous blood circuit, comprising: a blood pump which circulates the blood in the blood circuit to circulate it extracorporeally; an injection pump which injects an anticoagulant into a predetermined site; and a control unit which controls the blood pump and the injection pump, wherein the control unit is configured to: supply a drive signal to the injection pump to drive the injection pump when the blood circuit is filled with priming solution, supply a first drive signal to the blood pump to drive the blood pump in a first state when the anticoagulant is injected into the blood circuit by the driving of the injection pump, and supply a second drive signal to the blood pump when the anticoagulant is transported to the tip of the arterial blood circuit and / or the tip of the venous blood circuit by the first driving of the blood pump, and when the tip of the arterial blood circuit and the tip of the venous blood circuit are punctured into the patient.

2. A blood purification device as described in claim 1, comprising: a first solenoid valve for opening and closing an end of the arterial blood circuit; a second solenoid valve for opening and closing an end of the venous blood circuit; and a third solenoid valve for opening and closing a supply line for supplying dialysis fluid, wherein the control unit is configured to execute processing to open the first solenoid valve and the second solenoid valve before the anticoagulant is transferred, and to close the first solenoid valve and the second solenoid valve and to close the third solenoid valve after the anticoagulant has been transferred to the end of the arterial blood circuit or the end of the venous blood circuit.

3. A blood purification device as described in claim 2, wherein when the anticoagulant is transported to the tip of the venous blood circuit by the first driving of the blood pump and the tip of the arterial blood circuit and the tip of the venous blood circuit are inserted into the patient, the second solenoid valve and the third solenoid valve are opened and the first solenoid valve is closed.

4. A blood purification device as described in claim 2, wherein, when the anticoagulant is transported to the tip of the arterial blood circuit by the first drive of the blood pump and the tip of the arterial blood circuit and the tip of the venous blood circuit are inserted into the patient, the second solenoid valve is closed while the first solenoid valve and the third solenoid valve are appropriately opened.

5. A blood purification device as described in claim 4, which repeatedly performs a pressure accumulation process in which the blood pump is driven in a forward direction while the first solenoid valve and the second solenoid valve are closed and the third solenoid valve is open to accumulate pressure, and a process in which the blood pump is rotated in a reverse direction while the first solenoid valve is opened 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 execute a process for waiting until a predetermined time has elapsed after the blood pump has been driven in the second driving mode.

7. A blood purification device as described in claim 1, in which the end of the arterial blood circuit and the end of the venous blood circuit are connected to form a closed circuit and filled with priming solution, and the control unit drives the blood pump in the first manner when the anticoagulant is injected into the blood circuit by driving the injection pump.

8. A processing method executed by a control unit in a blood purification device equipped with a blood pump that circulates blood in a blood circuit extracorporeally and an injection pump that injects an anticoagulant into a predetermined site, comprising: a step of supplying a drive signal to the injection pump to drive the injection pump when the blood circuit is filled with priming solution; a step of supplying a first drive signal to the blood pump to drive the blood pump for a first time when the anticoagulant has been injected into the blood circuit by the drive of the injection pump; and a step of supplying a second drive signal to the blood pump to drive the blood pump for a second time when the anticoagulant has been transported to the tip of the arterial blood circuit and / or the tip of the venous blood circuit by the first drive of the blood pump, and the tip of the arterial blood circuit and the tip of the venous blood circuit are punctured into the patient.

9. In a blood purification device having a control unit that controls a blood pump that circulates blood in a blood circuit extracorporeally and an injection pump that injects an anticoagulant into a specified location, a program that causes the control unit to function as follows: when the blood circuit is filled with priming solution, a drive signal is supplied to the injection pump to drive the injection pump; when the anticoagulant has been injected into the blood circuit by the driving of the injection pump, a first drive signal is supplied to the blood pump to drive the blood pump for a first time; and when the anticoagulant has been transported to the tip of the arterial blood circuit and / or the tip of the venous blood circuit by the first drive of the blood pump, and when the tip of the arterial blood circuit and the tip of the venous blood circuit are punctured into the patient, a program that causes the control unit to function as follows:

Citation Information

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