Blood purification device

Abstract

The present invention provides a blood purification device, which includes: a blood circuit, which includes an arterial blood circuit and a venous blood circuit, and allows the patient's blood to circulate extracorporeally through the blood circuit; a blood purification unit, which is connected and arranged between the arterial blood circuit and the venous blood circuit and purifies the blood flowing through the blood circuit; a blood pump, which is arranged to the arterial blood circuit and injects the patient's blood from the end of the arterial blood circuit to the end of the venous blood circuit; a replacement pipeline, through which a replacement fluid is allowed to be introduced into the blood circuit; and an injection part, which is connected to the replacement pipeline and allows a predetermined drug liquid to be administered to the patient to be injected into the replacement pipeline from the injection part. The blood purification device includes: a control unit, which executes a drug introduction mode, in which the replacement fluid in the replacement pipeline is introduced into the blood circuit, and the control unit enables the drug liquid injected from the injection part in the drug introduction mode to be introduced into the blood circuit together with the replacement fluid; and a calculation unit, which calculates the volume of the replacement fluid introduced into the blood circuit from the replacement pipeline as the drug introduction mode is executed.

Description

Technical Field

[0001] The invention relates to a blood purification device for allowing a patient's blood to circulate extracorporeally while performing blood purification treatment. Background Art

[0002] In the technology of administering a medical solution to a patient during blood purification treatment performed by extracorporeal circulation of the patient's blood through a blood circuit, the medical solution is injected into the blood circuit and thus injected into the patient's body together with the patient's circulating blood returning to the patient's body. With respect to such a technology, a scheme is proposed to avoid injecting the medical solution directly into the blood circuit, wherein the medical solution is injected into a substitution line that allows a substitution fluid to be introduced into the blood line (see, for example, Patent Document 1).

[0003] List of existing technologies

[0004] Patent Literature

[0005] Patent Document 1: Japanese Patent Application No. JP2013-506471 Summary of the invention

[0006] Technical issues

[0007] However, in the above-mentioned prior art of introducing the drug solution into the blood circuit by injecting the drug solution into the substitution line, since the blood circulates extracorporeally through the blood circuit, some blood in the blood circuit may flow into the substitution line. If the dialysate flowing in the dialysate introduction line is used as the substitution fluid to be introduced, the substitution line is usually closed unless the substitution fluid is being introduced into the blood circuit. Therefore, if the timing of injecting the drug solution is not appropriate, the injection of the drug solution may be inappropriate. Therefore, it is necessary to let medical staff know the appropriate timing of injecting the drug solution.

[0008] The present invention is conceived in view of the above situation and provides a blood purification device that can prevent blood flowing in the blood circuit from flowing into the replacement line when the drug solution is injected into the blood circuit from the replacement line, and enables medical personnel to understand the appropriate time to inject the drug solution.

[0009] According to the invention of claim 1, a blood purification device is provided, which includes: a blood circuit, which includes an arterial blood circuit and a venous blood circuit, and through which the patient's blood is allowed to circulate extracorporeally; a blood purification unit, which is connected and arranged between the arterial blood circuit and the venous blood circuit and purifies the blood flowing through the blood circuit; a blood pump, which is arranged to the arterial blood circuit and transports the patient's blood from the end of the arterial blood circuit to the end of the venous blood circuit; a substitution line, which allows the introduction of substitution fluid into the blood circuit; and an injection part, which is connected to the substitution line and allows the predetermined drug solution to be given to the patient to be injected from the injection part into the substitution line. The blood purification device includes: a control unit, which executes a drug introduction mode, in which the substitution fluid in the substitution line is introduced into the blood circuit, and the control unit causes the drug solution injected from the injection part in the drug introduction mode to be introduced into the blood circuit together with the substitution fluid; and a calculation unit, which calculates the volume of the substitution fluid introduced into the blood circuit from the substitution line as the drug introduction mode is executed.

[0010] According to the invention of claim 2, in the blood purification apparatus according to claim 1, water of a volume corresponding to the volume of the replacement fluid calculated by the calculation unit is removed from the patient's blood by the blood purification unit.

[0011] According to the invention of claim 3, in the blood purification apparatus according to claim 1 or 2, when the drug introduction mode is executed, the control unit controls the pressure at the connection between the blood circuit and the substitution line to be equal to or lower than the hydraulic pressure in the substitution line.

[0012] According to the invention of claim 4, the blood purification device according to any one of claims 1 to 3 further includes: an arterial blood circuit opening and closing unit, which is arranged near the terminal part of the arterial blood circuit and can arbitrarily open or close the liquid flow path; and a replacement line opening and closing unit, which is arranged near the connection between the replacement line and the arterial blood circuit and can arbitrarily open or close the liquid flow path. In addition, the control unit performs the drug introduction mode by performing the following steps: a negative pressure generation step, which generates negative pressure in the part of the arterial blood circuit located between the terminal part and the blood pump by closing the replacement line opening and closing unit and the arterial circuit opening and closing unit; a suction step, which opens the replacement line opening and closing unit after the negative pressure generation step to suck the replacement fluid in the replacement line into the arterial blood circuit; and an introduction step, which introduces the replacement fluid in the replacement line into the arterial blood circuit by starting the blood pump after the suction step. In addition, in the suction step or the introduction step, the drug solution injected from the injection part is sucked or introduced into the blood circuit together with the replacement fluid.

[0013] According to the invention of claim 5, in the blood purification apparatus according to any one of claims 1 to 4, if a predetermined start-up operation is performed, the control unit executes the drug introduction mode.

[0014] According to the invention of claim 6, in the blood purification device according to claim 4 or 5, the control unit introduces the replacement fluid in the replacement line into the arterial blood circuit by starting the blood pump to generate negative pressure in the suction step and by keeping the blood pump in a started state in the introduction step.

[0015] According to the invention of claim 7, the blood purification device according to any one of claims 4 to 6 further includes: an air trap chamber, which is arranged at the connection between the arterial blood circuit and the replacement line; and a liquid level regulating pump, which regulates the surface height of the liquid layer in the air trap chamber by introducing air into the air layer in the air trap chamber or discharging air from the air layer in the air trap chamber. In addition, the control unit generates negative pressure by starting the liquid level regulating pump together with or instead of the blood pump in the suction step.

[0016] According to the invention of claim 8, the blood purification device according to any one of claims 1 to 3 further includes a substitution pump that is provided to the substitution line and delivers the substitution fluid to the blood circuit. In addition, the control unit performs a drug introduction mode by performing an introduction step that introduces the substitution fluid in the substitution line into the blood circuit by starting the substitution pump. In addition, the drug solution injected from the injection portion is introduced into the blood circuit together with the substitution fluid in the introduction step.

[0017] According to the invention of claim 9, in the blood purification device according to any one of claims 1 to 8, a target ultrafiltration volume for removing water from the patient's blood by the blood purification unit can be set. In addition, when the drug introduction mode is executed, the target ultrafiltration volume is corrected by adding the volume of the replacement fluid calculated by the calculation unit.

[0018] According to the invention of claim 10, the blood purification device according to any one of claims 1 to 9 further includes: a dialysate introduction line, through which the dialysate is introduced into the blood purification unit; a drainage discharge line, into which the drainage from the blood purification unit is discharged; and a side branch line, which is connected to the dialysate introduction line and the drainage discharge line, so that the dialysate in the dialysate introduction line bypasses the blood purification unit and flows into the drainage discharge line. In addition, the replacement line is connected to the dialysate introduction line and the blood circuit, thereby allowing the dialysate in the dialysate introduction line to be introduced into the blood circuit as a replacement fluid. In addition, when the drug introduction mode is executed, the control unit performs a side branch step, in which the control unit allows the dialysate to flow through the side branch line by closing the flow path that allows the dialysate to be introduced into the blood purification unit through the dialysate introduction line and discharged from the blood purification unit to the drainage discharge line.

[0019] According to the invention of claim 11, the blood purification device according to any one of claims 1 to 9 further includes a dialysate introduction line, through which the dialysate is introduced into the blood purification unit; and a drainage discharge line, into which the drainage from the blood purification unit is discharged. In addition, the replacement line is connected to the dialysate introduction line and the blood circuit, thereby allowing the dialysate in the dialysate introduction line to be introduced into the blood circuit as a replacement fluid. In addition, when the drug introduction mode is executed, the control unit causes the volume of water corresponding to the volume of the replacement fluid introduced into the blood circuit to be removed through the blood purification unit.

[0020] According to the invention of claim 12, the blood purification device according to claim 11 also includes a double pump, which is arranged across the dialysate inlet pipeline and the drain discharge pipeline, and transports the dialysate in the dialysate inlet pipeline to the drain discharge pipeline, and the double pump makes the volume of the dialysate to be transported through the dialysate inlet pipeline equal to the volume of the drain to be transported through the drain discharge pipeline.

[0021] According to the invention of claim 13, in the blood purification apparatus according to any one of claims 1 to 12, a prompt to prompt execution of the drug introduction mode or a prompt to prompt injection of the drug solution from the injection unit is displayed.

[0022] According to the invention of claim 14, in the blood purification device according to any one of claims 1 to 13, when the drug introduction mode is executed, the volume of the substitution fluid introduced into the blood circuit from the substitution line or the number of times the drug solution is injected from the injection part is displayed.

[0023] Advantageous Effects of the Invention

[0024] According to the invention of claim 1, the blood purification device includes: a control unit that executes a drug introduction mode in which a replacement fluid in a replacement line is introduced into a blood circuit, and the control unit causes the drug solution injected from the injection portion in the drug introduction mode to be introduced into the blood circuit together with the replacement fluid; and a calculation unit that calculates the volume of the replacement fluid introduced into the blood circuit from the replacement line as the drug introduction mode is executed. Therefore, when the drug solution is injected into the blood circuit from the replacement line, blood flowing in the blood circuit can be prevented from flowing into the replacement line. In addition, the medical staff is made aware of the appropriate timing of drug solution injection.

[0025] According to the invention of claim 2, the volume of water corresponding to the volume of the replacement fluid calculated by the calculation unit is removed from the patient's blood by the blood purification unit. Therefore, the volume of water corresponding to the volume of the replacement fluid introduced into the patient's body together with the medical solution is reliably removed.

[0026] According to the invention of claim 3, when the drug introduction mode is executed, the control unit controls the pressure at the connection between the blood circuit and the substitution line to be equal to or lower than the hydraulic pressure in the substitution line. Therefore, blood backflow into the substitution line is prevented from occurring.

[0027] According to the invention of claim 4, the control unit performs the drug introduction mode by the following steps: a negative pressure generation step of generating negative pressure in the portion between the terminal portion of the arterial blood circuit and the blood pump by closing the substitution line opening and closing unit and the arterial circuit opening and closing unit; a suction step of sucking the substitution fluid in the substitution line into the arterial blood circuit by opening the substitution line opening and closing unit after the negative pressure generation step; and an introduction step of introducing the substitution fluid in the substitution line into the arterial blood circuit by starting the blood pump after the suction step. Furthermore, in the suction step or the introduction step, the drug solution injected from the injection section is sucked or introduced into the blood circuit together with the substitution fluid. Therefore, by the negative pressure thus generated, the blood flowing in the blood circuit is more reliably prevented from flowing into the substitution line.

[0028] According to the invention of claim 5, if a predetermined start operation is performed, the control unit executes the medicine introduction mode. Therefore, the medicine liquid can be injected into the injection portion at any time.

[0029] According to the invention of claim 6, the control unit causes the substitution fluid in the substitution line to be introduced into the arterial blood circuit by starting the blood pump to generate negative pressure in the suction step and by keeping the blood pump started in the introduction step. Therefore, with the activation of the blood pump, the generation of negative pressure in the negative pressure generation step and the introduction of the substitution fluid in the introduction step are sequentially achieved.

[0030] According to the invention of claim 7, the blood purification device further includes: an air trap chamber, which is arranged at the connection between the arterial blood circuit and the replacement line; a liquid level regulating pump, which adjusts the surface height of the liquid layer in the air trap chamber by introducing air into the air layer in the air trap chamber or discharging air from the air layer in the air trap chamber. In addition, the control unit generates negative pressure by starting the liquid level regulating pump together with or instead of the blood pump in the suction step. Therefore, the negative pressure generated in the negative pressure generating step is generated by using the liquid level regulating pump.

[0031] According to the invention of claim 8, the blood purification device also includes a replacement pump, which is set to the replacement line and delivers the replacement fluid to the blood circuit. In addition, the control unit performs a drug introduction mode by performing an introduction step, which introduces the replacement fluid in the replacement line into the blood circuit by starting the replacement pump. In addition, the medicinal solution injected from the injection part is introduced into the blood circuit together with the replacement fluid in the introduction step. Therefore, when the medicinal solution is injected into the blood circuit from the replacement line, the activation of the replacement pump prevents the blood in the blood circuit from flowing into the replacement line. In addition, the medical staff is made aware of the appropriate time for the injection of the medicinal solution.

[0032] According to the invention of claim 9, a target ultrafiltration volume for removing water from the patient's blood by the blood purification unit can be set. In addition, when the drug introduction mode is executed, the target ultrafiltration volume is corrected by adding the volume of the replacement fluid calculated by the calculation unit. Therefore, in the blood purification treatment, the volume of water corresponding to the volume of the replacement fluid introduced into the patient's body with the execution of the drug introduction mode is automatically removed.

[0033] According to the invention of claim 10, the substitution line is connected to the dialysate introduction line and the blood circuit, thereby allowing the dialysate in the dialysate introduction line to be introduced into the blood circuit as a substitution fluid. In addition, when the drug introduction mode is executed, the control unit performs a bypass step in which the control unit allows the dialysate to flow through the bypass line by closing a flow path that allows the dialysate to be introduced into the blood purification unit through the bypass line and discharged from the blood purification unit into the drainage line. Therefore, the drug solution is prevented from being discharged from the blood purification unit into the drainage line.

[0034] According to the invention of claim 11, the substitution line is connected to the dialysate introduction line and the blood circuit, thereby allowing the dialysate in the dialysate introduction line to be introduced into the blood circuit as substitution fluid. In addition, when the drug introduction mode is executed, the control unit causes the volume of water corresponding to the volume of the substitution fluid introduced into the blood circuit to be removed through the blood purification unit. Therefore, the volume of water corresponding to the volume of the substitution fluid introduced into the blood circuit with the execution of the drug introduction mode is removed through the blood purification unit.

[0035] According to the invention of claim 12, the blood purification device further comprises a double pump, which is arranged across the dialysate inlet line and the drainage discharge line, and delivers the dialysate in the dialysate inlet line to the drainage discharge line, and the double pump makes the volume of the dialysate delivered through the dialysate inlet line equal to the volume of the drainage delivered through the drainage discharge line. Therefore, when the double pump is started, the volume of water corresponding to the volume of the replacement fluid sucked or introduced into the arterial blood circuit as the drug introduction mode is executed is naturally removed by the blood purification unit.

[0036] According to the invention of claim 13, a prompt to execute the drug introduction mode or a prompt to inject the drug solution from the injection unit is displayed. Therefore, it is possible to prevent the medical staff from forgetting to start the drug introduction mode or forgetting to inject the drug solution from the injection unit.

[0037] According to the invention of claim 14, when the drug introduction mode is executed, the volume of the replacement fluid introduced into the blood circuit from the replacement line or the number of times the drug solution is injected from the injection section is displayed. Therefore, medical staff can correctly understand the volume of the replacement fluid or the number of times the drug solution is injected. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] Figure 1 It is a schematic diagram of a blood purification device according to one embodiment of the present invention.

[0039] Figure 2 It is a schematic diagram showing items displayed on the display of the blood purification device.

[0040] Figure 3 : is a flowchart showing a control sequence of a drug introduction mode executed in the blood purification apparatus according to the first embodiment of the present invention.

[0041] Figure 4 1 is a schematic diagram of the blood purification device according to the first embodiment, showing a state in treatment (treatment mode).

[0042] Figure 5 is a schematic diagram of a blood purification device, showing the state of transition to a bypass step.

[0043] Figure 6 is a schematic diagram of a blood purification device, showing the state in a negative pressure generating step.

[0044] Figure 7 is a schematic diagram of a blood purification device, showing the states in the suction step and the introduction step.

[0045] Figure 8 is a flowchart showing a control sequence of a drug introduction mode executed in the blood purification apparatus according to the second embodiment of the present invention.

[0046] Fig. 9 is a flowchart showing a control sequence of a drug introduction mode executed in a blood purification apparatus according to a third embodiment of the present invention.

[0047] Fig.10 Schematic diagram showing a state of the blood purification device according to the third embodiment during a negative pressure generating step.

[0048] Fig.11 is a schematic diagram of a blood purification device, showing the states in the suction step and the introduction step.

[0049] Fig.12 1 is a flowchart showing a control sequence of a drug introduction mode executed in a blood purification device according to a fourth embodiment of the present invention.

[0050] Fig.13 1 is a schematic diagram showing a state in a treatment (treatment mode) of the blood purification device according to the fourth embodiment.

[0051] Fig.14 is a schematic diagram of a blood purification device, showing the state of transition to a bypass step.

[0052] Fig.15 is a schematic diagram of the blood purification device, showing the state in the introduction step.

[0053] Fig.16 : is a flowchart showing a control sequence of a drug introduction mode executed in a blood purification apparatus according to a fifth embodiment of the present invention.

[0054] Fig.17 is a schematic diagram of the blood purification device, showing the state in the introduction step.

[0055] Fig.18 : is a schematic diagram showing items (prompt for prompting execution of a drug introduction mode) provided on a display of a blood purification apparatus according to another embodiment of the present invention.

[0056] Fig.19 It is a schematic diagram showing items (promptness for prompting infusion from the infusion unit) provided on the display of the blood purification device according to still another embodiment of the present invention.

[0057] Fig. 20 is a schematic diagram of a blood purification device according to still another embodiment of the present invention (wherein the replacement fluid is supplied from a replacement fluid bag).

[0058] Fig.21 is a schematic diagram of a blood purification device according to another embodiment of the present invention (which includes a liquid level regulating pump). DETAILED DESCRIPTION

[0059] Embodiments of the present invention will now be described in detail with reference to the accompanying drawings.

[0060] The blood purification device of the following embodiments is applicable to a hemodialysis device, such as Figure 1 As shown, it basically includes: a blood circuit, in which an arterial blood circuit 2 and a venous blood circuit 3 are connected to a dialyzer 1, and the dialyzer 1 serves as a blood purification device; a dialysis device B, which includes a double pump 7, an ultrafiltration pump 10, a dialysate inlet line L1 and a drainage discharge line L2; a replacement line La, which is provided with an injection part 16; a control unit 17; a display 18; and a calculation unit 19.

[0061] The dialyzer 1 has a blood purification membrane (not shown) inside (the present embodiment uses a hollow fiber hemodialysis membrane or a hemodialysis filtration membrane, but a flat hemodialysis membrane may also be used). The dialyzer 1 also has: a blood inlet 1a, through which blood is introduced into the dialyzer; a blood outlet 1b, through which the blood introduced into the dialyzer is discharged from the dialyzer; a dialysate inlet 1c, through which the dialysate is introduced into the dialyzer; and a dialysate outlet 1d, through which the dialysate introduced into the dialyzer is discharged from the dialyzer. The blood introduced into the dialyzer 1 through the blood inlet 1a contacts the dialysate through the hollow fiber membrane, thereby being purified.

[0062] The arterial blood circuit 2 basically includes a flexible tube. One end of the arterial blood circuit 2 is connected to the blood inlet 1a of the dialyzer 1, thereby introducing blood collected from the patient's blood vessel into the hollow fiber membrane provided in the dialyzer 1. The other end of the arterial blood circuit 2 is provided with a connector a to which an arterial puncture needle c can be attached. The arterial blood circuit 2 is also provided with an arterial air trap chamber 5 for removing bubbles and a blood pump 4 at its midway position.

[0063] The blood pump 4 is a peristaltic pump disposed in the arterial blood circuit 2. When the blood pump 4 is started, the blood pump 4 squeezes the flexible tube, causing the patient's blood to flow from one side of the arterial puncture needle c to the blood inlet 1a of the dialyzer 1. With the start of the blood pump 4, the patient's blood is circulated extracorporeally from the end of the arterial blood circuit 2 to the end of the venous blood circuit 3.

[0064] Like the arterial blood circuit 2, the venous blood circuit 3 basically includes a flexible tube. One end of the venous blood circuit 3 is connected to the blood outlet 1b of the dialyzer 1, whereby the blood flowing through the hollow fiber membrane is discharged from the dialyzer 1. The other end of the venous blood circuit 3 is provided with a connector b, and the venous puncture needle d can be connected to the connector b. The venous blood circuit 3 is also provided with a venous air trap chamber 6 for removing bubbles at its midway position. The patient's blood collected by the arterial puncture needle c flows through the arterial blood circuit 2 and reaches the dialyzer 1, where the blood is purified. Then, the blood flows through the venous blood circuit 3 and returns to the patient's body through the venous puncture needle d. Therefore, extracorporeal circulation of blood is achieved. In this specification, the side provided with the blood collection (blood collection) puncture needle is called the "arterial" side, and the side provided with the blood return puncture needle is called the "venous" side. The "arterial" side and the "venous" side are not defined according to which of the artery and the vein is the puncture object.

[0065] The arterial blood circuit 2 is also provided with a clamping unit Va (arterial blood circuit opening and closing unit) at a position near its end (a position between the connector a and the blood pump 4 and near the connector a). The clamping unit Va can open or close the flow path. The venous blood circuit 3 is further provided with a clamping unit Vb at a position near its end (a position between the connector b and the venous air trap chamber 6 and near the connector b). The clamping unit Vb can open or close the flow path. The clamping unit Va is provided near the end portion of the arterial blood circuit 2 and serves as an "arterial blood circuit opening and closing unit" that can arbitrarily open or close the liquid flow path.

[0066] The dialysate inlet 1c and the dialysate outlet 1d of the dialyzer 1 receive one end of the dialysate inlet line L1 and one end of the drainage discharge line L2 connected thereto, respectively. The dialysate introduced into the dialyzer 1 through the dialysate inlet line L1 flows through the space outside the hollow fiber membrane and is discharged into the drainage discharge line L2 as drainage. The space inside the hollow fiber membrane (purification membrane) provided in the dialyzer 1 is used as a blood flow path, allowing blood to flow through the blood flow path. The space outside the hollow fiber membrane is used as a dialysate flow path, allowing dialysate to flow through the dialysate flow path.

[0067] The dialysis device B includes a dialysate inlet line L1 and a drain outlet line L2, and also includes a double pump 7, branch lines L3 to L6, and solenoid valves V1 to V9. The double pump 7 is arranged across the dialysate inlet line L1 and the drain outlet line L2. The double pump 7 allows the dialysate prepared with a predetermined condensation to be introduced into the dialyzer 1, and also allows the dialysate used for dialysis to be discharged from the dialyzer 1.

[0068] The double pump 7 according to the present embodiment includes a supply-side pump chamber and a discharge-side pump chamber having equal capacities, so that the volume of the dialysate delivered through the dialysate introduction line L1 and the discharge to be delivered through the discharge discharge line L2 become equal. The double pump 7 may be replaced with another type of delivery unit (not limited to a pump, but may be a balancing chamber, etc.) capable of delivering the dialysate in the dialysate introduction line L1 to the dialyzer 1.

[0069] The dialysate introduction line L1 is provided with a solenoid valve V1 at its midway position [a position on the downstream side (close to the dialyzer 1) relative to the joint between the dialysate introduction line L1 and the substitution line La]. The drain discharge line L2 is provided with a solenoid valve V2 at its midway position [a position on the upstream side (close to the dialyzer 1) relative to the joint between the drain discharge line L2 and the bypass line L3]. The dialysate introduction line L1 is also provided with filters 8 and 9 at corresponding positions between the duplex pump 7 and the solenoid valve V1. The filters 8 and 9 filter and thus purify the dialysate flowing through the dialysate introduction line L1, and are connected to the bypass lines L3 and L4, respectively. The bypass lines L3 and L4 each serve as a bypass to the drain discharge line L2 so as to introduce the dialysate into the drain discharge line L2.

[0070] The side branch lines L3 and L4 are provided with electromagnetic valves V3 and V4, respectively. When the electromagnetic valve V3 or the electromagnetic valve V4 is opened to open the corresponding flow path, the dialysate in the dialysate introduction line L1 is allowed to bypass the dialyzer 1 and flow into the drainage line L2. The dialysate introduction line L1 is also provided with an electromagnetic valve V6 at a position between the filter 8 and the filter 9.

[0071] The drainage discharge line L2 is provided with bypass lines L5 and L6. The bypass lines L5 and L6 each bypass the drainage side of the duplex pump 7. The bypass line L5 is provided with an ultrafiltration pump 10, which is provided for removing water from the patient's blood flowing through the dialyzer 1. The bypass line L6 is provided with a solenoid valve V5, which can open or close the flow path.

[0072] The drain discharge line L2 is also provided with a pressure pump 14 at a position on the upstream side relative to the double pump 7 (between the bypass line L5 and the joint of the double pump 7). The pressure pump 14 adjusts the hydraulic pressure on the drain side of the double pump 7. The drain discharge line L2 is also provided with a degassing chamber 15 at a position on the upstream side relative to the double pump 7 (between the pressure pump 14 and the double pump 7). The degassing chamber 15 is provided with an atmospheric release line L7 connected thereto via a check valve or the like. The atmospheric release line L7 is provided with a solenoid valve V7.

[0073] The substitution line La is connected to a position between the terminal portion of the arterial blood circuit 2 and the blood pump 4, thereby allowing the substitution fluid to be introduced into the arterial blood circuit 2. More specifically, one end of the substitution line La according to the present embodiment is connected to a collection port 11 (so-called sampling port) provided on the dialysate introduction line L1. The other end of the substitution line La is connected to the arterial blood circuit 2. The substitution line La serves as a flow path for supplying the dialysate in the dialysate introduction line L1 to the arterial blood circuit 2.

[0074] The substitution line La is provided with a clamping unit Vc capable of opening or closing the flow path. When the clamping unit Vc is opened, dialysate is supplied to the blood circuit through the dialysate introduction line L1, thereby performing priming before treatment, substitution during treatment (emergency infusion), or blood return after starting treatment. The clamping unit Vc is provided near the connection between the substitution line La and the arterial blood circuit 2, and serves as a "substitution line opening and closing unit" capable of arbitrarily opening or closing the liquid flow path.

[0075] The substitution line La according to the present embodiment is further provided with a rubber button 16 (infusion section) at a position between the collection port 11 and the clamping unit Vc. The rubber button 16 allows a predetermined liquid medicine [such as EPO (erythropoietin) (erythropoiesis-stimulating agent) etc.] that should be given to a patient to be injected into the substitution line La. For example, the tip of a syringe etc. is inserted into the rubber button 16, and the predetermined liquid medicine is injected. The rubber button 16 may be replaced by another type of injection section that allows the predetermined liquid medicine to be injected.

[0076] The control unit 17 is, for example, a microcomputer or the like provided in the dialysis apparatus B, and controls at least the following: opening or closing the actions of actuators such as the blood pump 4, the duplex pump 7, the solenoid valves V1 to V9, and the clamping units (Va to Vd) (particularly the clamping unit Va used as an arterial blood circuit opening and closing unit and the clamping unit Vc used as a substitution line opening and closing unit). The control unit 17 is electrically connected to sensors such as a hydraulic pressure measurement sensor, a venous pressure sensor, a bubble detection sensor, a condensation sensor, and a temperature sensor (none of which are shown) so as to be able to execute a predetermined control sequence.

[0077] In this embodiment, by supplying the dialysate in the dialysate introduction line L1 to the blood circuit, replacement (emergency infusion) during treatment and blood return after treatment can be achieved. For example, if the patient's blood pressure drops excessively during treatment, emergency infusion is a step of supplying the dialysate used as an emergency fluid to the blood circuit. Blood return is a step of returning the blood remaining in the blood circuit to the patient by supplying the dialysate used as a replacement fluid to the blood circuit after treatment.

[0078] The control unit 17 according to the present embodiment executes a drug introduction mode, which includes: a negative pressure generation step (pressure control step) of generating negative pressure in a portion between the terminal portion of the arterial blood circuit 2 and the blood pump 4 by closing the clamp unit Vc (substitution line opening and closing unit) and the clamp unit Va (arterial blood circuit opening and closing unit); a suction step of sucking the substitution fluid in the substitution line La into the arterial blood circuit 2 by opening the clamp unit Vc after the negative pressure generation step (pressure control step); and an introduction step of introducing the substitution fluid in the substitution line La into the arterial blood circuit 2 by starting the blood pump 4 after the suction step. In the suction step or the introduction step, the drug solution injected from the rubber button 16 (injection portion) is sucked or introduced into the arterial blood circuit 2 together with the substitution fluid.

[0079] The display 18 is a touch panel attached to the dialysis device B, such as Figure 2 As shown, the following contents can be displayed: a target ultrafiltration volume display section 18a, in which the target ultrafiltration volume is displayed; a start section 18b, which is used to start the operation of starting the drug introduction mode; a replacement volume display section 18c, in which the volume of the replacement fluid introduced from the replacement pipeline La into the arterial blood circuit 2 as the drug introduction mode is executed is displayed; an execution number display section 18d, in which the number of executions of the drug introduction mode [i.e., the number of times the drug solution is injected from the rubber button 16 (injection section)] is displayed; a treatment display section 18e, in which the duration of the blood purification treatment is displayed, etc.; an actual measurement display section 18f, in which the ultrafiltration volume (actual measured ultrafiltration volume) measured during the blood purification treatment (treatment mode) is displayed; and a ratio display section 18g, in which the ratio of the actual ultrafiltration volume to the target ultrafiltration volume is displayed in the form of a meter.

[0080] When the medical staff touches the start part 18b (predetermined operation), the control unit 17 executes the drug introduction mode, in which the volume of the replacement fluid introduced into the arterial blood circuit 2 from the replacement line La with the execution of the drug introduction mode is displayed in the replacement volume display part 18c, and the number of times the drug solution is injected from the rubber button 16 in this blood purification treatment is displayed in the execution number display part 18d. The calculation unit 19 calculates the volume of the replacement fluid introduced into the arterial blood circuit 2 from the replacement line La with the execution of the drug introduction mode. The volume of the replacement fluid thus calculated is displayed in the replacement volume display part 18c.

[0081] The display 18 can also provide prompts Q1, such as Fig.18 As shown, it prompts the execution of the drug introduction mode; or prompts Q2, such as Fig.19As shown, it prompts the injection of the drug solution from the rubber button 16 (injection portion). For example, when it is desired to start the drug introduction mode, the prompt Q1 is preferably provided as an image of a hand pointing to the start portion 18b (see Fig.18 On the other hand, when the injection of the medical solution is expected, the prompt provided in the treatment display section 18e is preferably changed to the prompt Q2, which is an image of the syringe and the rubber button 16 (see Fig.19 ).

[0082] Now, refer to Figure 3 The shown flowchart describes a control sequence executed by the control unit 17 according to the first embodiment.

[0083] In blood purification therapy, Figure 4 As shown, when the blood pump 4 and the double pump 7 are started while the patient is punctured with the arterial puncture needle c and the venous puncture needle d, the patient's blood is circulated in the extracorporeal blood circuit 2 and the venous blood circuit 3, thereby the blood undergoes blood purification treatment in the dialyzer 1. In the blood purification treatment (treatment mode), as shown in FIG. Figure 4 As shown, the clamp unit Va (arterial circuit opening and closing unit) and the clamp unit Vb are opened, while the clamp unit Vc (replacement line opening and closing unit) and the solenoid valves V3 and V4 are closed.

[0084] If it is necessary to administer liquid medicine to the patient, for example, in the middle or end stage of blood purification treatment, the medical staff touches the start portion 18b of the display 18, thereby executing the medicine introduction mode. When the medicine introduction mode is executed, Figure 5 As shown, the blood pump 4 is temporarily stopped. In addition, the electromagnetic valves V1 and V2 are closed. In addition, while the electromagnetic valve V4 remains closed, the electromagnetic valve V3 is opened, whereby the control sequence proceeds to the bypass step S1.

[0085] In the bypass step S1, the flow path that allows the dialysate to be introduced into the dialyzer 1 (blood purification unit) through the dialysate introduction line L1 and discharged from the dialyzer 1 (blood purification unit) to the drainage discharge line L2 is closed (i.e., the solenoid valves V1 and V2 are closed), so that the dialysate flows through the bypass line L3. When the bypass step S1 ends and the dialysate is introduced into the dialyzer 1 and the drainage from the dialyzer 1 stops, the negative pressure generation step (pressure control step) S2 is performed.

[0086] In the negative pressure generating step (pressure controlling step) S2, as Figure 6As shown, the blood pump 4 is started and the clamping unit Vc (replacement line opening and closing unit) and the clamping unit Va (arterial blood circuit opening and closing unit) are closed, thereby generating negative pressure in the portion between the end portion of the arterial blood circuit 2 (the portion closed by the clamping unit Va) and the blood pump 4. Specifically, since the clamping unit Va and the clamping unit Vc are closed, a closed circuit is established in which the blood pump 4 is started. Therefore, the blood in the closed circuit is discharged toward the downstream side of the blood pump 4. Therefore, negative pressure is generated. The negative pressure generating step (pressure control step) S2 continues until the number of revolutions of the rotor of the blood pump 4 reaches a preset value or until a predetermined period of time has passed after the start of the pump 4. When the negative pressure generating step (pressure control step) S2 ends, the suction step S3 is performed.

[0087] In the suction step S3 after the negative pressure generating step (pressure controlling step) S2, as Figure 7 As shown, the blood pump 4 remains active, and the clamping unit Vc (substitution line opening and closing unit) is opened, whereby the substitution fluid in the substitution line La is sucked into the arterial blood circuit 2. Specifically, in the negative pressure generating step (pressure controlling step) S2, a negative pressure is generated at the connection between the arterial blood circuit 2 and the substitution line La. In this state, when the clamping unit Vc is opened, the substitution fluid in the substitution line La is sucked into the arterial blood circuit 2 under negative pressure. The suction step S3 continues until the number of revolutions of the rotor of the blood pump 4 reaches a preset value or until a predetermined period of time has passed after the start of the suction step S3. When the suction step S3 ends, the introduction step S4 is performed.

[0088] In the introduction step S4 after the suction step S3, as Figure 7 As shown, the blood pump 4 remains activated, the clamping unit Vc (substitution line opening and closing unit) remains open, and the clamping unit Va (arterial blood circuit opening and closing unit) remains closed, whereby the activated blood pump 4 causes the substitution fluid in the substitution line La to be introduced into the arterial blood circuit 2. Specifically, when the suction step S3 is finished, the negative pressure at the connection between the arterial blood circuit 2 and the substitution line La is removed. Therefore, with the blood pump 4 remaining activated to perform liquid delivery, the substitution fluid in the substitution line La is introduced into the arterial blood circuit 2.

[0089] Therefore, if the drug solution to be administered to the patient is injected from the rubber button 16 during the period between the suction step S3 and the introduction step S4, the drug solution thus injected is sucked or introduced together into the arterial blood circuit 2. At the same time, on the display 18, the volume of the replacement fluid introduced into the arterial blood circuit 2 as the drug introduction mode is executed is displayed in the replacement volume display section 18c, and the number of executions of the drug introduction mode is displayed in the execution number display section 18d. The timing of injecting the drug solution from the rubber button 16 is arbitrary, but is preferably a time point between the suction step S3 and the introduction step S4.

[0090] Then, in S5, it is determined whether a preset volume of substitution fluid (substitution fluid containing a drug solution) has been introduced from the substitution line La into the arterial blood circuit 2 in the introduction step S4. If it is determined that the preset volume of substitution fluid has been introduced, the sequence proceeds to S6, where the mode is changed to Figure 4 The treatment mode shown. Therefore, the sequence of the drug introduction mode ends, and the mode is switched to the treatment mode, and the blood purification treatment is restarted. In the blood purification treatment, the driving speed of the blood pump 4 before the execution of the drug introduction mode is stored. After the drug introduction mode is completed, the stored driving speed is restored.

[0091] Now, refer to Figure 8 The shown flowchart describes a control sequence executed by the control unit 17 according to the second embodiment.

[0092] This embodiment adopts the same steps S1 to S5 as those adopted in the first embodiment. In S5, it is determined whether a preset volume of substitution fluid (substitution fluid containing a drug solution) has been introduced from the substitution line La into the arterial blood circuit 2 in the introduction step S4. If it is determined that the preset volume of substitution fluid has been introduced, the sequence proceeds to S6, where the target ultrafiltration volume is corrected.

[0093] In summary, in the present embodiment, the target ultrafiltration volume for removing water from the patient's blood by the dialyzer 1 can be set. In addition, the calculation unit 19 calculates the volume of the substitution fluid introduced from the substitution line La into the arterial blood circuit 2 as the drug introduction mode is executed. Therefore, when the drug introduction mode is executed, the target ultrafiltration volume is corrected by adding the volume of the substitution fluid calculated by the calculation unit 19.

[0094] After calibrating the target ultrafiltration volume as described above, enter S7 and switch to Figure 4 In this way, the sequence of the drug introduction mode ends, and the mode is switched to the treatment mode to restart the blood purification treatment. In the blood purification treatment, as in the case of the first embodiment, the driving speed of the blood pump 4 before the execution of the drug introduction mode is stored. After the drug introduction mode is completed, the stored driving speed is restored.

[0095] Now, refer to Fig. 9 The shown flowchart describes a control sequence executed by the control unit 17 according to the third embodiment.

[0096] In the blood purification treatment, as in the case of the first embodiment, Figure 4As shown, when the blood pump 4 and the double pump 7 are started while the patient is punctured with the arterial puncture needle c and the venous puncture needle d, the patient's blood is circulated in the extracorporeal space through the arterial blood circuit 2 and the venous blood circuit 3, thereby the blood undergoes blood purification treatment in the dialyzer 1. In the blood purification treatment (treatment mode), as shown in FIG. Figure 4 As shown, the clamp unit Va (arterial blood circuit opening and closing unit) and the clamp unit Vb are opened, while the clamp unit Vc (substitution line opening and closing unit) and the solenoid valves V3 and V4 are closed.

[0097] If it is necessary to administer liquid medicine to the patient, for example, in the middle or end stage of blood purification treatment, the medical staff touches the start portion 18b of the display 18, thereby executing the medicine introduction mode. When the medicine introduction mode is executed, the blood pump 4 is temporarily stopped (see Figure 5 ). Then, if Fig.10 As shown, the clamping unit Va (arterial blood circuit opening and closing unit) and the clamping unit Vc (substitution line opening and closing unit) are closed.

[0098] In this state, the solenoid valves V3 and V4 are closed, the solenoid valves V1 and V2 are opened, and the duplex pump 7 is started. Therefore, the dialysate is introduced into the dialyzer 1 through the dialysate introduction line L1, and the generated effluent is discharged from the dialyzer 1 into the effluent discharge line L2. In addition, since the duplex pump 7 is started, the volume of the dialysate transported through the dialysate introduction line L1 and the volume of the effluent transported through the effluent discharge line L2 are equal. Subsequently, the blood pump 4 is started, thereby performing the negative pressure generation step (pressure control step) S1.

[0099] In the negative pressure generating step (pressure controlling step) S1, Fig.10 As shown, the blood pump 4 is started and the clamping unit Vc (replacement line opening and closing unit) and the clamping unit Va (arterial blood circuit opening and closing unit) are closed, thereby generating negative pressure in the portion between the end portion of the arterial blood circuit 2 (the portion closed by the clamping unit Va) and the blood pump 4. Specifically, since the clamping unit Va and the clamping unit Vc are closed, a closed circuit is established in which the blood pump 4 is started. Therefore, the blood in the closed circuit is discharged toward the downstream side of the blood pump 4. Therefore, negative pressure is generated. The negative pressure generating step (pressure control step) S1 continues until the number of revolutions of the rotor of the blood pump 4 reaches a preset value or until a predetermined period of time has passed after the blood pump 4 starts to start. When the negative pressure generating step (pressure control step) S1 ends, the suction step S2 is performed.

[0100] In the suction step S2 after the negative pressure generating step (pressure controlling step) S1, as Fig.11As shown, the blood pump 4 remains started, and the clamping unit Vc (substitution line opening and closing unit) is opened, whereby the substitution fluid in the substitution line La is sucked into the arterial blood circuit 2. Specifically, in the negative pressure generating step (pressure controlling step) S1, a negative pressure is generated at the connection between the arterial blood circuit 2 and the substitution line La. In this state, when the clamping unit Vc is opened, the substitution fluid in the substitution line La is sucked into the arterial blood circuit 2 under negative pressure. The suction step S2 continues until the number of revolutions of the rotor of the blood pump 4 reaches a preset value or until a predetermined period of time has passed after the start of the suction step S2. When the suction step S2 ends, the introduction step S3 is performed.

[0101] In the introduction step S3 after the suction step S2, as Fig.11 As shown, the blood pump 4 remains activated, the clamping unit Vc (substitution line opening and closing unit) remains open, and the clamping unit Va (arterial blood circuit opening and closing unit) remains closed, whereby the activated blood pump 4 causes the substitution fluid in the substitution line La to be introduced into the arterial blood circuit 2. Specifically, when the suction step S2 is finished, the negative pressure at the connection between the arterial blood circuit 2 and the substitution line La is removed. Therefore, with the blood pump 4 remaining activated to perform liquid delivery, the substitution fluid in the substitution line La is introduced into the arterial blood circuit 2.

[0102] Therefore, if the medical fluid to be administered to the patient is injected from the rubber button 16 during the period between the suction step S2 and the introduction step S3, the medical fluid thus injected is sucked or introduced together into the arterial blood circuit 2. At the same time, on the display 18, the volume of the replacement fluid introduced into the arterial blood circuit 2 as the drug introduction mode is executed is displayed in the replacement volume display section 18c, and the number of executions of the drug introduction mode is displayed in the execution number display section 18d.

[0103] In the present embodiment, the volume of the dialysate delivered through the dialysate introduction line L1 and the volume of the drain delivered through the drain discharge line L2 are equal due to the activation of the duplex pump 7. Therefore, when the drug introduction mode is executed, the volume of water corresponding to the volume of the replacement fluid introduced into the arterial blood circuit 2 in the aspiration step S2 or the introduction step S3 is removed by the dialyzer 1.

[0104] Specifically, when the clamping unit Vc is opened, part of the dialysate in the dialysate introduction line L1 flows into the substitution line La and reaches the arterial blood circuit 2. Therefore, the volume of the dialysate introduced into the dialyzer 1 becomes smaller than the volume of the drainage by the volume of the dialysate flowing into the substitution line La. Therefore, the volume of water corresponding to the reduced amount is discharged from the dialyzer 1 into the drainage discharge line L2. Therefore, when the drug introduction mode is performed, the volume of water corresponding to the volume of the substitution fluid introduced into the arterial blood circuit 2 in the suction step S2 or the introduction step S3 is naturally removed through the dialyzer 1.

[0105] Then, in S4, it is determined whether a preset volume of replacement fluid (replacement fluid containing drug solution) has been introduced from the replacement line La into the arterial blood circuit 2 in the introduction step S3. If it is determined that the preset volume of replacement fluid has been introduced, the process proceeds to S5, where the mode is switched to Figure 4 In this way, the sequence of the drug introduction mode ends, and the mode is switched to the treatment mode, thereby restarting the blood purification treatment. In the blood purification treatment, the driving speed of the blood pump 4 before the execution of the drug introduction mode is stored. After the drug introduction mode is completed, the stored driving speed is restored.

[0106] Now, refer to Fig.12 The shown flowchart describes a control sequence executed by the control unit 17 according to the fourth embodiment.

[0107] In blood purification therapy, Fig.13 As shown, when the blood pump 4 and the double pump 7 are started while the patient is punctured with the arterial puncture needle c and the venous puncture needle d, the patient's blood is circulated in the extracorporeal blood circuit 2 and the venous blood circuit 3, thereby the blood undergoes blood purification treatment in the dialyzer 1. In the blood purification treatment (treatment mode), as shown in FIG. Fig.13 As shown, the clamp unit Va (arterial circuit opening and closing unit) and the clamp unit Vb are opened, while the clamp unit Vc (replacement line opening and closing unit) and the solenoid valves V3 and V4 are closed.

[0108] The blood purification device of this embodiment has a replacement line Lb, which branches out from the middle of the replacement line La and is connected to a position between the dialyzer 1 and the venous air trap chamber 6 of the venous blood circuit 3. The device also includes a replacement pump 20 provided to the replacement line Lb. When the replacement pump 20 is started, the dialysate as the replacement fluid is introduced into the venous blood circuit 3 from the dialysate introduction line L1. The replacement pump 20 is a peristaltic pump. When the replacement pump 20 is started, the replacement pump 20 squeezes the flexible tube to transport the replacement fluid. When the replacement pump 20 stops, the flow path of the flexible tube is closed.

[0109] The substitution line Lb of the present embodiment is provided with a rubber button 16 as an injection portion at a position on the upstream side relative to the substitution pump 20 (between the substitution pump 20 and the collection port 11). The rubber button 16 allows a predetermined liquid medicine to be administered to the patient to be injected into the substitution line Lb. In the present embodiment, the end of the substitution line Lb is connected to a position between the dialyzer 1 and the venous air trap chamber 6 of the venous blood circuit 3. Alternatively, the end of the substitution line Lb may be connected to any other position, such as another position of the venous blood circuit 3 or a predetermined position of the arterial blood circuit 2, as long as the position is defined in the blood circuit and is on the downstream side relative to the blood pump 4.

[0110] If it is necessary to administer liquid medicine to the patient, for example, in the middle or end stage of blood purification treatment, the medical staff touches the start portion 18b of the display 18, thereby executing the medicine introduction mode. When the medicine introduction mode is executed, the blood pump 4 is temporarily stopped (see Figure 5 ). Then, if Fig.14 As shown, the solenoid valves V1 and V2 are closed. In addition, the solenoid valve V3 is opened while the solenoid valve V4 remains closed, whereby the control sequence proceeds to the branch step S1.

[0111] In the bypass step S1, the flow path that allows the dialysate to be introduced into the dialyzer 1 (blood purification unit) through the dialysate introduction line L1 and discharged from the dialyzer 1 (blood purification unit) to the drainage line L2 is closed (i.e., the solenoid valves V1 and V2 are closed), so that the dialysate flows through the bypass line L3. When the bypass step S1 is completed and the dialysate is introduced into the dialyzer 1 and the drainage is stopped from the dialyzer 1, the introduction step S2 is performed.

[0112] In the introduction step S2 after the branching step S1, if Fig.15 As shown, the blood pump 4 is kept activated, and the substitution pump 20 is activated, and the substitution fluid in the substitution line Lb is introduced into the blood circuit (the venous blood circuit 3 in this embodiment), so the liquid medicine injected from the rubber button 16 (injection part) is introduced into the blood circuit together with the substitution fluid. Specifically, before the substitution pump 20 is activated, the flow path of the substitution line Lb is closed. However, with the activation of the substitution pump 20, the substitution fluid in the substitution line Lb flows into the blood circuit.

[0113] Prior to the execution of the introduction step S2, a positive pressure is preferably generated in the portion of the substitution line Lb located on the upstream side relative to the substitution pump 20 by starting the duplex pump 7. In this case, the drug solution injected into the upstream side relative to the substitution pump 20 is retained near the substitution pump 20. Therefore, when the substitution pump 20 is started, the drug solution is delivered to the blood circuit (in the present embodiment, the venous blood circuit 3) without flowing back to the dialysate introduction line L1. In addition, such a positive pressure generated in the portion of the substitution line Lb on the upstream side relative to the substitution pump 20 also prevents the occurrence of backflow of blood in the blood circuit (in the present embodiment, the venous blood circuit 3) through the gap in the substitution pump 20 (a gap that may be generated if the flexible tube is not completely closed by the roller).

[0114] Therefore, if the drug liquid to be administered to the patient is injected from the rubber button 16, the drug liquid thus injected is introduced into the blood circuit (venous blood circuit 3) together with the substitution fluid in the substitution line Lb. At the same time, on the display 18, the volume of the substitution fluid introduced into the venous blood circuit 3 along with the execution of the drug introduction mode is displayed in the substitution volume display section 18c, and the execution number of the drug introduction mode is displayed in the execution number display section 18d.

[0115] Then, in S3, it is determined whether a preset volume of replacement fluid (replacement fluid containing a drug solution) has been introduced from the replacement line Lb into the venous blood circuit 3 in the introduction step S2. If it is determined that a preset volume of replacement fluid has been introduced, the sequence proceeds to S4, where the target ultrafiltration volume is corrected. In summary, in the present embodiment, the target ultrafiltration volume for removing water from the patient's blood by the dialyzer 1 is settable. In addition, the calculation unit 19 calculates the volume of the replacement fluid introduced from the replacement line Lb into the venous blood circuit 3 (any part of the blood circuit located on the downstream side relative to the blood pump 4) while executing the drug introduction mode. Therefore, when the drug introduction mode is executed, the target ultrafiltration volume is corrected by adding the volume of the replacement fluid calculated by the calculation unit 19.

[0116] After calibrating the target ultrafiltration volume as described above, enter S5 and switch to Fig.13 In this way, the sequence of the drug introduction mode ends, and the mode is switched to the treatment mode, thereby restarting the blood purification treatment. In the blood purification treatment, as in the case of the first embodiment, the driving speed of the blood pump 4 is controlled to be higher than the driving speed in the drug introduction mode.

[0117] Now, refer to Fig.16 The shown flowchart describes a control sequence executed by the control unit 17 according to the fifth embodiment.

[0118] This embodiment uses the same substitution pump 20 and substitution line Lb as those used in the fourth embodiment. In the blood purification treatment, as in the fourth embodiment, Fig.13 As shown, when the patient is punctured with the arterial puncture needle c and the venous puncture needle d, the blood pump 4 and the double pump 7 are started, so that the patient's blood circulates extracorporeally through the arterial blood circuit 2 and the venous blood circuit 3, thereby the blood undergoes blood purification treatment in the dialyzer 1. In the blood purification treatment (treatment mode), as shown in FIG. Fig.13 As shown, the clamp unit Va (arterial blood circuit opening and closing unit) and the clamp unit Vb are opened, while the clamp unit Vc (substitution line opening and closing unit) and the solenoid valves V3 and V4 are closed.

[0119] If it is necessary to administer liquid medicine to the patient, for example, in the middle or end stage of blood purification treatment, the medical staff touches the start portion 18b of the display 18, thereby executing the medicine introduction mode. When the medicine introduction mode is executed, Fig.17 As shown, the replacement pump 20 is started, thereby performing the introduction step S1. In this state, the solenoid valves V3 and V4 are closed, the solenoid valves V1 and V2 are opened, and the duplex pump 7 is started. Therefore, the dialysate is introduced into the dialyzer 1 through the dialysate introduction pipeline L1, and the generated effluent is discharged from the dialyzer 1 into the effluent discharge pipeline L2. In addition, since the duplex pump 7 is started, the volume of the dialysate transported through the dialysate introduction pipeline L1 and the volume of the effluent transported through the effluent discharge pipeline L2 are equal.

[0120] In the introduction step S1, the blood pump 4 is kept in the activated state, and the substitution pump 20 is activated, whereby the substitution fluid in the substitution line Lb is introduced into the blood circuit (the venous blood circuit 3 in this embodiment), and thus the drug solution injected from the rubber button 16 (injection portion) is introduced into the blood circuit together with the substitution fluid. Specifically, before the substitution pump 20 is activated, the flow path of the substitution line Lb is closed. However, with the activation of the substitution pump 20, the substitution fluid in the substitution line Lb flows into the blood circuit.

[0121] Prior to the execution of the introduction step S1, a positive pressure is preferably generated in the portion of the substitution line Lb on the upstream side relative to the substitution pump 20 by starting the duplex pump 7. In this case, the drug solution injected into the portion upstream of the substitution pump 20 is retained near the substitution pump 20. Therefore, when the substitution pump 20 is started, the drug solution is delivered to the blood circuit (in the present embodiment, the venous blood circuit 3) without flowing back to the dialysate introduction line L1. In addition, such a positive pressure generated in the portion of the substitution line Lb on the upstream side relative to the substitution pump 20 also prevents the occurrence of backflow of blood in the blood circuit (in the present embodiment, the venous blood circuit 3) through the gap in the substitution pump 20 (a gap that may be generated if the flexible tube is not completely closed by the roller).

[0122] Therefore, if the drug liquid to be administered to the patient is injected from the rubber button 16, the drug liquid thus injected is introduced into the blood circuit (venous blood circuit 3) together with the substitution fluid in the substitution line Lb. At the same time, on the display 18, the volume of the substitution fluid introduced into the venous blood circuit 3 along with the execution of the drug introduction mode is displayed in the substitution volume display section 18c, and the execution number of the drug introduction mode is displayed in the execution number display section 18d.

[0123] In the present embodiment, the volume of the dialysate delivered through the dialysate introduction line L1 and the volume of the drain delivered through the drain discharge line L2 are equal due to the activation of the double pump 7. Therefore, when the drug introduction mode is executed, the volume of water corresponding to the volume of the replacement fluid introduced into the venous blood circuit 3 in the introduction step S1 is removed through the dialyzer 1.

[0124] Specifically, when the substitution pump 20 is started, part of the dialysate in the dialysate introduction line L1 flows into the substitution line Lb and reaches the venous blood circuit 3. Therefore, the volume of the dialysate introduced into the dialyzer 1 becomes smaller than the volume of the drainage by the volume of the dialysate flowing into the substitution line Lb. Therefore, the volume of water corresponding to the reduced amount is discharged from the dialyzer 1 into the drainage discharge line L2. Therefore, when the drug introduction mode is performed, the volume of water corresponding to the volume of the substitution fluid introduced into the venous blood circuit 3 in the introduction step S1 is naturally removed through the dialyzer 1.

[0125] Then, in S2, it is determined whether a preset volume of replacement fluid (replacement fluid containing drug solution) has been introduced from the replacement line Lb into the venous blood circuit 3 in the introduction step S1. If it is determined that the preset volume of replacement fluid has been introduced, the process proceeds to S3, where the mode is switched to Fig.13 Thus, the sequence of the drug introduction mode ends, and the mode is switched to the treatment mode, thereby restarting the blood purification treatment. In the blood purification treatment, the driving speed of the blood pump 4 is controlled to be higher than the driving speed in the drug introduction mode.

[0126] According to each of the first to fifth embodiments, the blood purification device includes a control unit that executes a drug introduction mode, in which the replacement fluid in the replacement lines La and Lb is introduced into the blood circuit, and the control unit causes the drug solution injected from the rubber button 16 (injection unit) in the drug introduction mode to be introduced into the blood circuit together with the replacement fluid; the calculation unit calculates the volume of the replacement fluid introduced into the blood circuit from the replacement lines La and Lb as the drug introduction mode is executed. Therefore, when the drug solution is injected into the blood circuit from the replacement lines La and Lb, the blood flowing in the blood circuit is prevented from flowing into the replacement lines La and Lb. In addition, the medical staff is informed of the appropriate time for the injection of the drug solution. In addition, since the blood purification device includes a calculation unit 19, which calculates the volume of the replacement fluid introduced into the blood circuit from the replacement lines La and Lb as the drug introduction mode is executed, the volume of the replacement fluid introduced into the patient's body as the drug introduction mode is executed is recognizable for ultrafiltration in blood purification treatment.

[0127] In particular, according to each of the first to third embodiments, a drug introduction mode is performed, which includes: a negative pressure generation step (pressure control step) of generating negative pressure in the portion of the arterial blood circuit 2 between the terminal portion and the blood pump 4 by closing the clamp unit Vc (substitution line opening and closing unit) and the clamp unit Va (arterial blood circuit opening and closing unit); a suction step (pressure control step) of sucking the substitution fluid in the substitution line La into the arterial blood circuit 2 by opening the clamp unit Va after the negative pressure generation step; and an introduction step of introducing the substitution fluid in the substitution line La into the arterial blood circuit 2 by starting the blood pump 4 after the suction step. Furthermore, in the suction step or the introduction step, the drug solution injected from the rubber button 16 (injection portion) is sucked or introduced into the arterial blood circuit 2 together with the substitution fluid. Therefore, by the negative pressure generated when the drug solution is injected from the substitution line La into the blood circuit, the blood flowing in the blood circuit is more reliably prevented from flowing into the substitution line La.

[0128] According to each of the first to fifth embodiments, if a predetermined start operation is performed, the control unit 17 executes the drug introduction mode. Therefore, the drug solution can be injected into the injection section at any time. According to each of the first to third embodiments, the control unit 17 causes the substitution fluid in the substitution line La to be introduced into the arterial blood circuit 2 by starting the blood pump 4 in the suction step for generating negative pressure and by keeping the blood pump 4 in the started state in the introduction step. Therefore, with the activation of the blood pump 4, the generation of negative pressure in the negative pressure generation step (pressure control step) and the introduction of the substitution fluid in the introduction step are continuously achieved.

[0129] According to the second embodiment, a target ultrafiltration volume for removing water from the patient's blood by the dialyzer 1 is settable. In addition, when the drug introduction mode is executed, the target ultrafiltration volume is corrected by adding the volume of the replacement fluid calculated by the calculation unit 19. Therefore, in the blood purification treatment, as the drug introduction mode is executed, the volume of water corresponding to the volume of the replacement fluid introduced into the patient's body is automatically removed.

[0130] According to each of the first, second and fourth embodiments, the substitution lines La, Lb are connected to the dialysate introduction line L1 and the blood circuit, thereby allowing the dialysate in the dialysate introduction line L1 to be introduced into the blood circuit as a substitution fluid. In addition, when the drug introduction mode is executed, the control unit 17 performs a bypass step, in which the control unit 17 allows the dialysate to flow through the bypass line L3 by closing a flow path that allows the dialysate to be introduced into the dialyzer 1 through the dialysate introduction line L1 and discharged from the dialyzer 1 to the drain discharge line L2. Therefore, the drug solution is prevented from being discharged from the dialyzer 1 into the drain discharge line L2.

[0131] According to each of the third and fifth embodiments, the substitution lines La, Lb are connected to the dialysate introduction line L1 and the blood circuit, thereby allowing the dialysate in the dialysate introduction line L1 to be introduced into the blood circuit as substitution fluid. In addition, when the drug introduction mode is executed, the control unit 17 causes the volume of water corresponding to the volume of the substitution fluid introduced into the blood circuit in the aspiration step or the introduction step to be removed through the dialyzer 1. Therefore, the volume of water corresponding to the volume of the substitution fluid sucked or introduced into the blood circuit with the execution of the drug introduction mode is removed through the dialyzer 1.

[0132] In particular, according to each of the third and fifth embodiments, the blood purification apparatus includes a double pump 7, which is arranged across the dialysate introduction line L1 and the drainage discharge line L2, and the dialysate in the dialysate introduction line L1 is transported to the drainage discharge line L2, and the double pump 7 makes the volume of the dialysate transported through the dialysate introduction line L1 equal to the volume of the drainage transported through the drainage discharge line L2. Therefore, when the double pump 7 is started, the volume of water corresponding to the volume of the replacement fluid sucked or introduced into the blood circuit as the drug introduction mode is executed is naturally removed through the dialyzer 1.

[0133] According to each of the first to fifth embodiments, if the blood purification device is configured to display a prompt to prompt the execution of the drug introduction mode or a prompt to prompt the injection of the drug solution from the rubber button 16 (injection unit), it is prevented that the medical staff forgets to start the drug introduction mode or forgets to inject the drug solution from the rubber button 16. In addition, when the drug introduction mode is executed, the volume of the replacement fluid introduced into the blood circuit from the replacement lines La, Lb or the number of times the drug solution is injected from the rubber button 16 (injection unit) is displayed. Therefore, the medical staff can correctly understand the volume of the replacement fluid or the number of times the drug solution is injected.

[0134] According to each of the fourth and fifth embodiments, the blood purification device includes a substitution pump 20 that is set to the substitution line Lb and delivers the substitution fluid to the blood circuit. In addition, the control unit 17 performs a drug introduction mode by executing an introduction step of introducing the substitution fluid in the substitution line Lb into the blood circuit by starting the substitution pump 20. In addition, the drug solution injected from the rubber button 16 (injection portion) is introduced into the blood circuit together with the substitution fluid in the introduction step. Therefore, when the drug solution is injected into the blood circuit from the substitution line Lb, the activation of the substitution pump 20 prevents the blood in the blood circuit from flowing into the substitution line Lb. In addition, the medical staff is made aware of the appropriate timing of drug solution injection.

[0135] Although some embodiments have been described above, the present invention is not limited thereto. For example, the timing of injecting the medical solution from the rubber button 16 is not limited to the point in the suction step or the introduction step as in the above-mentioned embodiments [i.e., after the clamping unit Vc (replacement line opening and closing unit) is opened in the suction step]. The medical solution may be injected from the rubber button 16 before the suction step. In this case, as Fig. 20 As shown, the above-mentioned substitution line La can be replaced by a substitution line La', which is connected to a bag containing saline as a substitution fluid and allows the saline as a substitution fluid to be introduced into the arterial blood circuit 2 by opening the clamping unit Vc (substitution line opening and closing unit).

[0136] Or, if Fig.21 As shown, the blood purification apparatus may include an air trap chamber D provided at a connection between the arterial blood circuit 2 and the substitution line La, and a liquid level regulating pump M for regulating the surface height of the liquid layer in the air trap chamber D by introducing air into the air layer in the air trap chamber D or discharging air from the air layer in the air trap chamber D. In addition, the control unit 17 may start the liquid level regulating pump M together with or instead of the blood pump 4 in the suction step.

[0137] In this case, the negative pressure generated in the negative pressure generating step (pressure controlling step) can be generated by using a liquid level regulating pump M for regulating the liquid level in the air trap chamber D. Fig.21, reference characters Vd and S respectively denote a clamping unit provided in a flow path for introducing air into or exhausting air from the air trap chamber D, and a pressure measuring unit for measuring the pressure in the flow path.

[0138] In addition, it is preferred that the dialyzer 1 (blood purification unit) removes a volume of water corresponding to the volume of the replacement fluid calculated by the calculation unit 19 from the patient's blood. In this case, the ultrafiltration of the dialyzer 1 can be performed in a drug introduction mode or a treatment mode. In either mode, the volume of water corresponding to the volume of the replacement fluid introduced into the patient's body together with the drug solution is reliably removed.

[0139] In addition, the negative pressure generating step (pressure controlling step) is not limited to the step of generating negative pressure, as long as it is a step of controlling the pressure at the connection between the blood circuit (arterial blood circuit 2 or venous blood circuit 3) and the substitution line (La or Lb) to be equal to or lower than the hydraulic pressure in the substitution line (La or Lb) when the drug introduction mode is executed. For example, in each of the first to third embodiments, a closed system can be established by closing the clamping unit Va (arterial blood circuit opening and closing unit) and the clamping unit Vc (substitution line opening and closing unit) and then the blood pump 4 is rotated forward or reversed to control the hydraulic pressure with reference to the atmospheric pressure (0 kPa). Alternatively, in each of the fourth and fifth embodiments, since the portion of the substitution line Lb located on the upstream side relative to the substitution pump 20 forms a closed system filled with dialysate, the pressure can be controlled by controlling the driving speed of the double pump 7. In summary, if the control unit 17 controls the pressure at the connection between the blood circuit and the substitution line Lb when the drug introduction mode is executed, the occurrence of blood backflow into the substitution line Lb is avoided.

[0140] Industrial Applicability

[0141] The present invention is also applicable to a blood purification device having additional functions, etc., as long as the device includes: a control unit that executes a drug introduction mode for introducing a replacement fluid in a replacement line into a blood circuit, the control unit causing the drug fluid injected from an injection portion in the drug introduction mode to be introduced into the blood circuit together with the replacement fluid; and a calculation unit that calculates the volume of the replacement fluid introduced from the replacement line into the blood circuit as the drug introduction mode is executed.

[0142] Reference numerals list

[0143] 1 dialyzer (blood purification unit)

[0144] 2 Arterial blood circuit

[0145] 3 Venous blood circuit

[0146] 4 Blood Pump

[0147] 5 Arterial Air Trap Chamber

[0148] 6 Venous Air Trap Chamber

[0149] 7Double pump

[0150] 8.9 Filter

[0151] 10Ultrafiltration pump

[0152] 11 Collection Port

[0153] 12 Hydraulic measurement sensor

[0154] 13. Venous pressure sensor

[0155] 14 Pressure pump

[0156] 15 Degassing chamber

[0157] 16 Rubber button (injection part)

[0158] 17Control Unit

[0159] 18 Display

[0160] 19 computing units

[0161] 20 Replacement pump

[0162] L1 Dialysate inlet line

[0163] L2 liquid discharge line

[0164] L3 bypass pipeline

[0165] L4 bypass pipeline

[0166] L7 atmospheric release line

[0167] La, Lb replacement pipeline

[0168] B dialyzer

[0169] Va clamping unit (arterial blood circuit opening and closing unit) Vc clamping unit (replacement line opening and closing unit) a, b connectors.

Claims

1. A blood purification device, comprising: a blood circuit, which includes an arterial blood circuit and a venous blood circuit and through which the patient's blood is allowed to circulate extracorporeally; a blood purification unit connected to and disposed between the arterial blood circuit and the venous blood circuit and purifying blood flowing through the blood circuit; a blood pump provided to the arterial blood circuit and conveying the patient's blood from an end of the arterial blood circuit to an end of the venous blood circuit; a substitution line allowing the introduction of substitution fluid into the blood circuit; and an injection section connected to the substitution line and allowing a predetermined drug solution to be administered to a patient to be injected from the injection section into the substitution line, The blood purification device includes: a control unit, the control unit executing a drug introduction mode, in which the replacement fluid in the replacement line is introduced into the blood circuit, the control unit causing the drug solution injected from the injection part in the drug introduction mode to be introduced into the blood circuit together with the replacement fluid; and a calculation unit that calculates the volume of the replacement fluid introduced from the replacement line into the blood circuit as the drug introduction mode is executed, The blood purification device also includes: an arterial blood circuit opening and closing unit which is provided near a terminal portion of the arterial blood circuit and which can arbitrarily open or close a liquid flow path; and a substitution line opening and closing unit, which is arranged near the connection between the substitution line and the arterial blood circuit and can arbitrarily open or close the liquid flow path, The control unit executes the drug introduction mode by executing the following steps: a negative pressure generating step of generating negative pressure in a portion of the arterial blood circuit between the terminal portion and the blood pump by closing the substitution line opening and closing unit and the arterial blood circuit opening and closing unit; A suction step, the suction step opening the substitution line opening and closing unit after the negative pressure generating step to suck the substitution fluid in the substitution line into the arterial blood circuit; and an introducing step of introducing the substitution fluid in the substitution line into the arterial blood circuit by starting the blood pump after the aspiration step, wherein, in the suction step or the introduction step, the drug solution injected from the injection portion is sucked or introduced into the blood circuit together with the replacement fluid, A volume of water corresponding to the volume of the replacement fluid calculated by the calculation unit is removed from the patient's blood by the blood purification unit.

2. The blood purification device according to claim 1, wherein: When the drug introduction mode is executed, the control unit controls the pressure at the connection between the blood circuit and the substitution line to be equal to or lower than the hydraulic pressure in the substitution line.

3. The blood purification device according to claim 1 or 2, wherein: If a predetermined start operation is performed, the control unit executes the medicine introduction mode.

4. The blood purification device according to claim 3, wherein: The control unit causes the substitution fluid in the substitution line to be introduced into the arterial blood circuit by activating the blood pump to generate negative pressure in the aspiration step and by keeping the blood pump in an activated state in the introduction step.

5. The blood purification device according to claim 3, wherein: Also includes: an air trap chamber disposed at a connection between the arterial blood circuit and the substitution line; a liquid level regulating pump for regulating the surface height of the liquid layer in the air trap chamber by introducing air into the air layer in the air trap chamber or discharging air from the air layer in the air trap chamber, The control unit generates negative pressure by activating the liquid level regulating pump together with or instead of the blood pump during the suction step.

6. The blood purification device according to claim 4, wherein: Also includes: an air trap chamber disposed at a connection between the arterial blood circuit and the substitution line; a liquid level regulating pump for regulating the surface height of the liquid layer in the air trap chamber by introducing air into the air layer in the air trap chamber or discharging air from the air layer in the air trap chamber, The control unit generates negative pressure by activating the liquid level regulating pump together with or instead of the blood pump during the suction step.

7. The blood purification device according to claim 1 or 2, further comprising: a substitution pump provided to the substitution line and delivering the substitution fluid to the blood circuit, wherein the control unit executes the drug introduction mode by executing an introduction step of introducing the substitution fluid in the substitution line into the blood circuit by starting the substitution pump, and wherein the drug solution injected from the injection portion is introduced into the blood circuit together with the substitution fluid in the introduction step.

8. The blood purification device according to claim 1 or 2, wherein: A target ultrafiltration volume for removing water from the patient's blood by the blood purification unit is settable, and wherein, when the drug introduction mode is executed, the target ultrafiltration volume is corrected by adding the volume of the replacement fluid calculated by the calculation unit.

9. The blood purification device according to claim 1 or 2, wherein: Also includes: a dialysate introduction line, through which the dialysate is introduced into the blood purification unit; a effluent discharge line into which effluent from the blood purification unit is discharged; as well as A side branch line is connected to the dialysate inlet line and the drainage line, so that the dialysate in the dialysate inlet line bypasses the blood purification unit and flows into the drainage line. wherein the replacement line is connected to the dialysate introduction line and the blood circuit, thereby allowing the dialysate in the dialysate introduction line to be introduced into the blood circuit as the replacement fluid, and wherein, when the drug introduction mode is executed, the control unit performs a bypass step, in which the control unit allows the dialysate to flow through the bypass line by closing the flow path that allows the dialysate to be introduced into the blood purification unit through the dialysate introduction line and discharged from the blood purification unit into the drain discharge line.

10. The blood purification device according to claim 1 or 2, wherein: Also includes: a dialysate introduction line, through which the dialysate is introduced into the blood purification unit; as well as a effluent discharge line into which effluent from the blood purification unit is discharged, wherein the substitution line is connected to the dialysate introduction line and the blood circuit, thereby allowing the dialysate in the dialysate introduction line to be introduced into the blood circuit as the substitution fluid, and wherein, when the drug introduction mode is executed, the control unit causes a volume of water corresponding to the volume of the substitution fluid introduced into the blood circuit to be removed through the blood purification unit.

11. The blood purification device according to claim 10, wherein: It also includes a double pump, which is arranged across the dialysate introduction pipeline and the drain discharge pipeline, and transports the dialysate in the dialysate introduction pipeline to the drain discharge pipeline. The double pump makes the volume of dialysate to be transported through the dialysate introduction pipeline equal to the volume of drain to be transported through the drain discharge pipeline.

12. The blood purification device according to claim 1 or 2, wherein: A prompt to prompt execution of the drug introduction mode or a prompt to prompt injection of the drug solution from the injection section is displayed.

13. The blood purification device according to claim 1 or 2, wherein: When the drug introduction mode is executed, the volume of the substitution fluid introduced from the substitution line into the blood circuit or the number of times the drug solution is injected from the injection portion is displayed.

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