Medicinal liquid supply device and medicinal liquid dilution method
The drug solution supply device addresses the limitations of conventional heparin delivery systems by allowing flexible use of various packaging materials and enabling multiple treatments from a single package, enhancing treatment efficiency and reducing costs.
Patent Information
- Application Number
- PCT/JP2024/042639
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2023-12-12
- Filing Date
- 2024-12-03
- Publication Date
- 2025-06-19
AI Technical Summary
Conventional systems for delivering heparin in dialysis treatments are limited by the need for specific vial shapes and sizes, restricting the use of alternative packaging materials and requiring all heparin in a vial to be used in a single treatment, making multiple treatments difficult.
A drug solution supply device that includes a composition holding part for introducing and holding an anticoagulant, such as heparin, and a connecting part that allows the composition to be led out to a blood circuit, enabling the use of various packaging materials and allowing multiple treatments from a single package.
The device allows for flexible use of different packaging materials for heparin and enables multiple treatments from a single package, reducing waste and treatment costs while simplifying the administration process.
Smart Images

Figure JP2024042639_19062025_PF_FP_ABST
Abstract
Description
Chemical solution supply device and chemical solution dilution method
[0001] The present invention relates to a chemical solution supplying device and a chemical solution dilution method.
[0002] Heparin is sometimes used as a blood anticoagulant in dialysis devices and the like. Generally, heparin is delivered in a vial or the like. In a system using heparin contained in a vial, the heparin can be used immediately from the vial by simply setting the vial in the device (see, for example, Patent Document 1).
[0003] Japanese Patent Application Laid-Open No. 2021-118944
[0004] In conventional systems, vials were set into the device. This meant that only vials of a certain shape and size that could be used with the system were required. This meant that the heparin packaging was limited to vials. Furthermore, treatments could only be performed using heparin in packaged units, making it difficult to perform multiple treatments.
[0005] The present invention has been made in view of the above points, and aims to provide a drug solution supplying device that is not easily limited by the packaging material of drug solutions such as heparin, and that can be used for multiple treatments with a single package of drug solution.
[0006] The medicinal solution supplying device according to the present invention is characterized in that it supplies medicinal solution to a blood circuit of a blood purification device that purifies blood, and comprises: a composition holding section into which an anticoagulant contained in a container can be introduced from the container and which holds a composition containing at least the introduced anticoagulant; and a connecting section which connects the composition holding section to the blood circuit and enables the composition to be led out of the composition holding section to the blood circuit.
[0007] It is less restricted by the packaging material of medicinal liquids such as heparin, and one package of medicinal liquid can be used for multiple treatments.
[0008] FIG. 1 is a schematic diagram showing the configuration of a liquid medicine supplying device according to a first embodiment. FIG. 2 is a schematic diagram showing a filling process in the liquid medicine supplying device according to the first embodiment. FIG. 3 is a schematic diagram showing a dilution process in the liquid medicine supplying device according to the first embodiment. FIG. 4 is a schematic diagram showing an administration preparation process in the liquid medicine supplying device according to the first embodiment. FIG. 5 is a schematic diagram showing a dilution process (a) and an administration preparation process (b) in the liquid medicine supplying device according to the second embodiment. FIG. 6 is a schematic diagram showing the configuration of a liquid medicine supplying device according to a third embodiment. FIG. 7 is a schematic diagram showing a filling process in the liquid medicine supplying device according to the third embodiment. FIG. 8 is a schematic diagram showing a dilution process in the liquid medicine supplying device according to the third embodiment. FIG. 9 is a functional block diagram explaining the function of a control device 66. FIG. 10 is a flowchart showing the overall processing of the control device 66.
[0009] <<<<<<Outline of the Present Embodiment>>>>>> Conventionally, heparin has been used as a blood anticoagulant in dialysis treatment. Heparin is often delivered in vials or filled in syringes.
[0010] When using heparin stored in a vial, the vial is directly inserted into the device to administer the heparin. However, it is difficult to use packaging materials other than vials that are compatible with the device. Furthermore, with ordinary vials, the entire heparin contained in the vial must be used in one treatment, making it difficult to use heparin over multiple treatments.
[0011] The size and shape of packaging materials such as vials often depend on the device, and there were few options for packaging materials that could be used.
[0012] Thus, there has been a demand for an apparatus or system that increases the options for packaging materials so that the desired heparin can be used, and that allows packaging materials to be used multiple times.
[0013] <<<<<<Details of the Present Embodiments>>>>>> First to third embodiments will be described below with reference to the drawings.
[0014] <<Direction>> <Upward direction, upper side, upward facing, upward, etc.> The upward direction is the opposite direction to the downward direction described below, and is the opposite direction to the direction of gravity.
[0015] <Downward, lower side, downward, downwards, etc.> Downward is the direction of gravity. In other words, downward is the direction indicated by the string that suspends the object.
[0016] <Up-down direction> The up-down direction is a direction along the upward and downward directions. The orientation does not matter as long as it is along the upward and downward directions.
[0017] <Longitudinal direction> This refers to the direction in which a member having a long shape extends, i.e., the direction in which the longest part or region extends.
[0018] <Longitudinal direction> In a member having a long shape, this refers to the direction in which the member extends in the shortest direction, for example, the direction perpendicular to the longitudinal direction. This refers to the direction in which the shortest part or region extends.
[0019] <<<<<First Embodiment>>>>> <<<Configuration of Blood Purification Apparatus 70>>> Figure 1 is a schematic diagram showing the configuration of a drug solution supplying apparatus 10A according to a first embodiment. The drug solution supplying apparatus 10A of the first embodiment is connected to a blood purification apparatus 70 and is applied to a hemodialysis apparatus.
[0020] The blood purification device 70 mainly comprises a dialyzer 20 having a blood purification function, a blood circuit to which an arterial blood circuit 30 and a venous blood circuit 40 are connected, a blood pump 50, a dialysis device main body 60 to which a dialysate inlet line 62 and a dialysate outlet line 64 are connected, a control device 66, a drug solution clamping means 120, a diaphragm pump 130, a liquid level adjustment pump 140, a liquid level detection device 150, and an empty-dialysis detection device 160.
[0021] <Dialyzer 20> The dialyzer 20 has a blood purification membrane (not shown). The blood purification membrane may be a hollow fiber hemodialysis membrane or hemodiafiltration membrane, or a flat membrane hemodialysis membrane. The dialyzer 20 has a blood inlet 22 and a blood outlet 24. The blood inlet 22 is an opening through which blood is introduced into the dialyzer 20. The blood outlet 24 is an opening through which blood introduced into the dialyzer 20 is discharged. The dialyzer 20 also has a dialysate inlet 26 and a dialysate outlet 28. The dialysate inlet 26 is an opening through which dialysate is introduced into the dialyzer 20. The dialysate outlet 28 is an opening through which the dialysate introduced into the dialyzer 20 is discharged. The dialyzer 20 purifies blood by bringing the dialysate into contact with the blood introduced from the blood inlet 22 via the blood purification membrane.
[0022] <Arterial Blood Circuit 30> The arterial blood circuit 30 mainly comprises a flexible, long tube. The arterial blood circuit 30 has a first end 32 and a second end 34. The first end 32 of the arterial blood circuit 30 is connected to the blood inlet 22 of the dialyzer 20. Blood collected from a patient's blood vessel is introduced from the first end 32 of the arterial blood circuit 30 through the blood inlet 22 of the dialyzer 20 into the blood purification membrane of the dialyzer 20. A connector (not shown) for attaching an arterial puncture needle (not shown) can be provided at the second end 34 of the arterial blood circuit 30.
[0023] <Venous Blood Circuit 40> Similar to the arterial blood circuit 30, the venous blood circuit 40 mainly comprises a flexible, long tube. The venous blood circuit 40 has a first end 42 and a second end 44, and an air trap chamber (not shown) located midway. The first end 42 of the venous blood circuit 40 is connected to the blood outlet 24 of the dialyzer 20. Blood that has passed through the blood purification membrane is discharged from the blood outlet 24 of the dialyzer 20. The second end 44 of the venous blood circuit 40 may be provided with a connector (not shown) for attaching a venous puncture needle (not shown).
[0024] <Blood Pump 50> The blood pump 50 is disposed between the first end 32 and the second end 34 of the arterial blood circuit 30. The blood pump 50 is configured as a tube pump. The tube pump has rotatable rollers (not shown). The rotating rollers compress the tubes, causing the blood and priming solution in the tubes of the arterial blood circuit 30 to flow.
[0025] <Extracorporeal Circulation> The patient's blood is collected through the arterial puncture needle, passes through the arterial blood circuit 30, reaches the dialyzer 20, and after blood purification, flows through the venous blood circuit 40 and returns to the patient's body through the venous puncture needle, thereby completing extracorporeal circulation.
[0026] <Arterial side and venous side> The side of the puncture needle that removes (collects) blood is referred to as the “arterial side,” and the side of the puncture needle that returns blood is referred to as the “venous side.” Therefore, whether it is referred to as the “arterial side” or the “venous side” does not depend on whether the blood vessel to be punctured is an artery or a vein.
[0027] <Arterial clamping means 36 and venous clamping means 46> An arterial clamping means 36 capable of opening and closing the flow path of the arterial blood circuit 30 is disposed at the distal end of the arterial blood circuit 30. A venous clamping means 46 capable of opening and closing the flow path of the venous blood circuit 40 is disposed at the distal end of the venous blood circuit 40. The arterial clamping means 36 and the venous clamping means 46 are controlled to an open or closed state by a control signal output from the control device 66.
[0028] <Dialysate introduction line 62 and dialysate discharge line 64> A dialysate introduction line 62 is connected to the dialysate inlet 26 of the dialyzer 20. A dialysate discharge line 64 is connected to the dialysate discharge port 28 of the dialyzer 20. The dialysate is introduced into the dialyzer 20 via the dialysate introduction line 62, passes through the outside of the hollow fiber membrane, and can be discharged from the dialysate discharge line 64. The inside of the hollow fiber membrane (purification membrane) of the dialyzer 20 forms a blood flow path through which blood can flow, and the outside of the hollow fiber membrane forms a dialysate flow path through which dialysate can flow.
[0029] <Dialysis device main body 60> A dialysate inlet line 62 and a dialysate outlet line 64 are extended from the dialysis device main body 60. The dialysis device main body 60 has a solution feed pump and a water removal pump (neither of which are shown). The solution feed pump introduces dialysate prepared to a predetermined concentration into the dialyzer 20 and discharges the dialysate after dialysis from the dialyzer 20. The water removal pump removes water from the blood flowing through the dialyzer 20.
[0030] <Control device 66> Figure 10 is a functional block diagram illustrating the overall function of the dialysis machine main body 60 including the control device 66. The dialysis machine main body 60 includes an input unit, the control device 66, and an output unit.
[0031] The input unit is a device or part, such as a touch panel or keyboard, that can be operated by an operator of the dialysis machine main body 60. The operator can input data and control instructions from the input unit. When the input unit detects an input operation by the operator, it outputs a detection signal corresponding to the input operation to the control device 66.
[0032] The control device 66 mainly has a processor (such as a CPU (Central Processing Unit)), a ROM (Read Only Memory), a RAM (Random Access Memory), an I / O (Input / Output Interface), an I / F (Interface Device), an auxiliary storage device (such as an HDD (Hard Disk Drive) or an SSD (Solid State Drive)), etc. The ROM stores programs and constants for executing various processes such as control processes. The RAM temporarily stores variable values used when a program is executed, etc.
[0033] The output section mainly includes a blood pump 50, a liquid level adjustment pump 140, a drug solution clamping means 120, an arterial clamping means 36, and a solenoid valve 370 (a third embodiment described later). When an operator operates the input section, the input section outputs a detection signal corresponding to the input operation to the control device 66, and the control device 66 outputs a control signal to the output section, thereby controlling the output section.
[0034] The control device 66 outputs various control signals and inputs various detection signals via the I / O. For example, the control device 66 outputs control signals to the chemical liquid clamping means 120, the diaphragm pump 130, the liquid level adjustment pump 140, etc., which will be described later. The control device 66 also inputs detection signals from the liquid level detection device 150, the empty detection device 160, etc.
[0035] <<Chemical Solution Clamping Means 120>> The chemical solution clamping means 120 is provided on the chemical solution line 100 (described below) of the chemical solution supply device 10A. The chemical solution clamping means 120 is in either an open state or a closed state. When the chemical solution clamping means 120 is in the open state, liquid can flow within the chemical solution line 100. When the chemical solution clamping means 120 is in the closed state, liquid cannot flow within the chemical solution line 100.
[0036] The chemical solution clamping means 120 has a driving device (not shown) such as a solenoid or a motor. The driving device is driven by a control signal output from the control device 66, and the chemical solution clamping means 120 is set to an open state or a closed state.
[0037] <<Diaphragm Pump 130>> The diaphragm pump 130 has a deformable diaphragm 131. The diaphragm pump 130 controls the flow of liquid by deformation of the diaphragm 131. The diaphragm 131 of the diaphragm pump 130 is driven by the liquid level control pump 140. The diaphragm pump 130 presses or sucks the diaphragm 131 by the liquid level control pump 140. The diaphragm 131 is deformed by pressing or sucking the diaphragm 131, generating positive or negative pressure in the arterial blood circuit 30 or the venous blood circuit 40, thereby controlling the flow of liquid in the arterial blood circuit 30 or the venous blood circuit 40. The diaphragm pump 130 can repeatedly press and suck by the liquid level control pump 140.
[0038] In the first embodiment, the diaphragm pump 130 is provided in both the arterial blood circuit 30 and the venous blood circuit 40. In the first embodiment, the diaphragm pump 130 provided in the arterial blood circuit 30 is mainly used. The diaphragm pump 130 can cause the liquid to flow within the arterial blood circuit 30.
[0039] <<Liquid Level Adjustment Pump 140>> The liquid level adjustment pump 140 deforms the diaphragm 131 of the diaphragm pump 130. The liquid level adjustment pump 140 presses or sucks the diaphragm 131 of the diaphragm pump 130.
[0040] The liquid level adjustment pump 140 has a driving device (not shown) such as a solenoid or a motor. The driving device of the liquid level adjustment pump 140 is driven by a control signal output from the control device 66, and the liquid level adjustment pump 140 performs pressure or suction.
[0041] <<Liquid Level Detector 150>> The liquid level detector 150 can detect the amount of undiluted heparin or diluted heparin introduced into the pipette 110. The liquid level detector 150 outputs a signal indicative of the liquid level to the control device 66.
[0042] <<Empty Detector 160>> The empty detector 160 can detect whether undiluted heparin or diluted heparin is present in the pipette 110. The empty detector 160 outputs a signal indicating that heparin or diluted heparin is not present. By providing the empty detector 160, diluted heparin can be dispensed until the pipette 110 is empty in the administration preparation process described below, thereby reducing waste due to residual medicinal solution. Furthermore, because the dispense of diluted heparin can be stopped when the pipette 110 is empty, the risk of air being mixed into the arterial blood circuit 30 can be reduced.
[0043] <<<Medicines, etc.>>> <Heparin (anticoagulant)> Heparin is used as an anticoagulant in dialysis treatment. It is usually delivered sealed in a syringe or similar container.
[0044] <Priming Solution (Diluting Solution)> In dialysis treatment, saline, dialysate, etc. are used as priming solutions. In dialysis treatment, heparin is diluted with the priming solution.
[0045] <<<Configuration of the Drug Solution Supplying Device 10A>>> The drug solution supplying device 10A can be provided outside the blood circuit, and can be used with minimal changes to the existing blood circuit.
[0046] As shown in FIG. 1, the chemical solution supplying device 10A mainly includes a chemical solution line 100 and a pipette 110.
[0047] <<Drug Solution Line 100>> The drug solution line 100 is connected to the blood circuit. A liquid can flow between the drug solution line 100 and the blood circuit. The liquid can be, but is not limited to, a priming solution or diluted heparin. For example, the drug solution line 100 is connected to and communicates with the arterial blood circuit 30. The drug solution line 100 is preferably made of a flexible tube or the like. The pipette 110 can be positioned at a location remote from the arterial blood circuit 30.
[0048] The drug solution line 100 is connected to the arterial blood circuit 30 at a connector 180. The drug solution line 100 is preferably detachably connected at the connector 180. The drug solution line 100 can be used as a disposable device.
[0049] <<Pipette 110>> Heparin and a priming solution are introduced into the pipette 110. Inside the pipette 110, the heparin is diluted with the priming solution. A pipette is an instrument for containing, temporarily storing, and transferring small amounts of liquid. The pipette may have a measuring scale. By using the measuring scale, the volume can be measured simply and easily. The pipette can be used as a disposable instrument. Note that the pipette is not limited to a pipette, and any container can be used as long as it can temporarily contain heparin and a priming solution and can dispense undiluted heparin or diluted heparin.
[0050] The pipette 110 has an elongated shape overall. The pipette 110 is arranged so that its longitudinal direction is aligned with the vertical direction. The pipette 110 is provided so that it can be inverted upside down. The pipette 110 can be in either an upright state or an inverted state. The upright state is a state in which the upper end opening 114 (described below) of the pipette 110 opens upward, and is the state of the pipette 110 in the administration preparation process (see FIG. 4) or the dilution process (see FIG. 3). The inverted state is a state in which the upper end opening 114 of the pipette 110 opens downward, and is the state of the pipette 110 in the filling process (see FIG. 2).
[0051] The operation of inverting the pipette 110 may be performed manually or by using a driving device such as a motor (not shown). The control device 66 of the blood purification device 70 outputs a control signal to the driving device such as a motor to invert the pipette 110 upside down. When the control device 66 of the blood purification device 70 outputs an upright command signal, the pipette 110 is brought into an upright position by the driving device such as a motor. By outputting the upright command signal, the control device 66 can determine that the state of the pipette 110 is upright. When the control device 66 of the blood purification device 70 outputs an inverted command signal, the pipette 110 is brought into an inverted position by the driving device such as a motor. By outputting the inverted command signal, the control device 66 can determine that the state of the pipette 110 is inverted.
[0052] A sensor (not shown) may also be provided to detect whether the pipette 110 is in an upright or inverted state. The sensor may be optical, mechanical, or another detection method, as long as it detects whether the pipette 110 is in an upright or inverted state and outputs a signal indicating the detection result. The control device 66 of the blood purification device 70 can obtain the state of the pipette 110 by receiving the signal indicating the detection result emitted from the sensor. Even if a malfunction occurs in a driving device such as a motor, the state of the pipette 110 can be accurately obtained.
[0053] Furthermore, when the operator manually turns the pipette 110 upside down, the operator operates the touch panel after completing the upside-down operation. For example, when the operator turns the pipette 110 upright, the operator inputs information indicating that the pipette 110 has been turned upright into the touch panel. This operation causes the touch panel to output a signal indicating that the pipette 110 has been turned upright to the control device. This allows the control device 66 to determine that the pipette 110 is in the upright state. On the other hand, when the operator turns the pipette 110 upside down, the operator inputs information indicating that the pipette 110 has been turned upside down into the touch panel. This operation causes the touch panel to output a signal indicating that the pipette 110 has been turned upside down to the control device. This allows the control device 66 to determine that the pipette 110 is in the inverted state.
[0054] The pipette 110 mainly has a housing portion 112, an extension portion 113, an upper end opening 114, and a lower end opening 116.
[0055] <Storage section 112> The storage section 112 has a long, approximately cylindrical shape. Heparin and a priming solution are introduced into the storage section 112. When the priming solution is introduced into the storage section 112, the heparin is diluted with the priming solution in the storage section 112. When the priming solution is not introduced into the storage section 112, the heparin is not diluted with the priming solution in the storage section 112, and the storage section 112 simply contains heparin.
[0056] <Extension Portion 113> The extension portion 113 has a long, substantially cylindrical shape. The extension portion 113 extends from an upper portion of the storage portion 112 in a direction away from the storage portion 112. The extension portion 113 has a diameter narrower than the storage portion 112. By making the extension portion 113 narrower than the storage portion 112, the extension portion 113 can be easily inserted into and removed from the openings of various containers. This allows the pipette 110 to be compatible with containers of various shapes and sizes, and to introduce the heparin contained therein into the pipette 110. In particular, the extension portion 113 is preferably formed so as to become thinner (tapered) as it moves away from the storage portion 112. This makes it even easier to insert and remove the extension portion 113 from and into the openings of various containers.
[0057] The extending portion 113 is disposed concentrically with the housing portion 112. That is, the extending portion 113 is disposed so that the central axis of the extending portion 113 coincides with the central axis of the housing portion 112.
[0058] <Upper end opening 114> The extension portion 113 has an upper end opening 114 at its upper end (the portion farthest from the storage portion 112). The upper end opening 114 communicates with the storage portion 112 and the extension portion 113. The upper end opening 114 can be connected to a vial (see FIG. 2). Heparin stored in a vial is introduced into the storage portion 112 from the upper end opening 114 through the extension portion 113.
[0059] When the pipette 110 is in a normal upright position, the upper opening 114 faces upward. On the other hand, when the pipette 110 is in an inverted position, the upper opening 114 faces downward. Note that the pipette 110 is in an inverted position, and the heparin is introduced into the storage section 112 through the upper opening 114 with the pipette 110 turned upside down and the upper opening 114 facing downward.
[0060] <Bottom Opening 116> The pipette 110 has a bottom opening 116 at its bottom. The bottom opening 116 communicates with the storage section 112. The pipette 110 is connected to the drug solution line 100 at the bottom opening 116. The priming solution is introduced into the storage section 112 from the bottom opening 116 via the drug solution line 100. Furthermore, heparin diluted with the priming solution is discharged from the storage section 112 to the drug solution line 100 via the bottom opening 116. When the pipette 110 is in a normal upright position without being inverted upside down, the bottom opening 116 faces downward. Note that the priming solution and diluted heparin are introduced and discharged when the pipette 110 is in a normal upright position without being inverted upside down, i.e., with the bottom opening 116 facing downward. Furthermore, heparin that is not diluted with the priming solution is also dispensed when the pipette 110 is in the normal upright position without being turned upside down, that is, with the lower end opening 116 facing downward.
[0061] <<Other Configurations of the Drug Solution Supplying Device 10A>> In the example shown, the drug solution supplying device 10A mainly includes a drug solution line 100 and a pipette 110, and the blood purification device 70 mainly includes a dialyzer 20 having a blood purification function, a blood circuit to which an arterial blood circuit 30 and a venous blood circuit 40 are connected, a blood pump 50, a dialysis device main body 60 to which a dialysate inlet line 62 and a dialysate outlet line 64 are connected, a control device 66, drug solution clamping means 120, a diaphragm pump 130, a liquid level adjustment pump 140, a liquid level detection device 150, and an empty-dialysis detection device 160.
[0062] The configuration is not limited to this, and the liquid medicine supplying apparatus 10A may include at least one of the liquid medicine clamping means 120, the diaphragm pump 130, the liquid level adjustment pump 140, the liquid level detection device 150, and the empty detection device 160. For example, the liquid medicine supplying apparatus 10A may be provided with a control device (not shown) having a processor (processing device) or the like, so that control signals can be output from the control device and detection signals can be input to the control device. Furthermore, the control device of the liquid medicine supplying apparatus 10A is connected to the control device 66 of the blood purification apparatus 70 so that they can communicate with each other. Among the liquid medicine clamping means 120, the diaphragm pump 130, the liquid level adjustment pump 140, the liquid level detection device 150, and the empty detection device 160, those controlled by the control device 66 of the blood purification apparatus 70 and those controlled by the control device of the liquid medicine supplying apparatus 10A are appropriately divided and controlled.
[0063] Alternatively, only the control device of the chemical liquid supplying device 10A may control all of the chemical liquid clamping means 120, the diaphragm pump 130, the liquid level adjustment pump 140, the liquid level detection device 150, and the empty detection device 160. The chemical liquid clamping means 120, the diaphragm pump 130, and the liquid level adjustment pump 140 are controlled by control signals output from the control device of the chemical liquid supplying device 10A, and the detection signals output from the liquid level detection device 150 and the empty detection device 160 are input to the control device of the chemical liquid supplying device 10A.
[0064] <<Processing by Medical Solution Supply Apparatus 10A>> Fig. 2 is a schematic diagram showing a filling process by medical solution supply apparatus 10A according to the first embodiment. Fig. 3 is a schematic diagram showing a dilution process by medical solution supply apparatus 10A according to the first embodiment. Fig. 4 is a schematic diagram showing an administration preparation process by medical solution supply apparatus 10A according to the first embodiment. As shown in Figs. 2 to 4, the processing by medical solution supply apparatus 10A includes a filling process, a dilution process, and an administration preparation process.
[0065] 2 to 4, valves shown in white indicate that they are in an open state, and valves shown in black indicate that they are in a closed state. Furthermore, in FIGS. 2 to 4, the presence of heparin is indicated by diagonal lines, and the presence of priming solution is indicated by horizontal lines. A white arrow pointing left on the diaphragm pump 130 indicates that the diaphragm 131 is being pressed, and a white arrow pointing right on the diaphragm pump 130 indicates that the diaphragm 131 is being sucked.
[0066] <<Filling Process>> As shown in Figure 2, the filling process is a process of introducing heparin from a vial into the pipette 110. By using the filling process, heparin stored in a container such as a vial (such as the container in which it was delivered) can be introduced into the pipette 110. Heparin can be used regardless of the shape of the container in which it was delivered or the shape of the container, such as the opening of the container. This allows for compatibility with a wide variety of containers that can hold heparin. Note that the blood pump 50 is stopped during the filling process.
[0067] 2(a) shows the first step of the filling step. At this point, both the drug solution clamping means 120 and the artery clamping means 36 are in the open state (shown in white).
[0068] First, a vial containing heparin is placed below the pipette 110. Next, the pipette 110 is turned upside down so that the top opening 114 is positioned at the bottom (inverted state). The pipette 110 can be turned upside down manually or by a control signal from the control device 66. By providing a driving device such as a motor to the pipette 110, the pipette 110 can be turned upside down by a control signal. The top opening 114 positioned at the bottom is inserted into the vial to communicate with the vial.
[0069] <Filling Step 2> FIG. 2(b) shows the second step of the filling step.
[0070] The processor of the control device 66 outputs a control signal to close the chemical solution clamping means 120 (shown in black). The processor of the control device 66 outputs a control signal to drive the liquid level adjustment pump 140 to press the diaphragm 131 of the diaphragm pump 130.
[0071] <Filling Step 3> FIG. 2(c) shows the final step of the filling step.
[0072] The processor of the control device 66 outputs a control signal to stop the blood pump 50 and close (black) the arterial clamping means 36. The processor of the control device 66 outputs a control signal to open (white) the medical solution clamping means 120.
[0073] The processor of the control device 66 outputs a control signal to drive the liquid level adjustment pump 140 to suck the diaphragm 131 of the diaphragm pump 130. This creates a negative pressure inside the pipette 110. When the inside of the pipette 110 is in a negative pressure state, the heparin contained in the vial is sucked out of the vial and introduced into the pipette 110.
[0074] An amount of heparin corresponding to the difference between the deformation due to pressure of the diaphragm 131 of the diaphragm pump 130 and the deformation due to suction is introduced into the pipette 110. By deforming the diaphragm 131 of the diaphragm pump 130 at least once, a desired amount of heparin can be introduced from the vial into the pipette 110.
[0075] By the filling process shown in FIGS. 2(a) to 2(c), heparin can be introduced into the pipette 110 regardless of the shape of the container in which the heparin is stored or the shape of the container, such as the opening.
[0076] After the filling step is completed, the pipette 110 is turned upside down (returned from an inverted state to an upright state) so that the upper opening 114 is positioned at the top. As with the filling step, the pipette 110 can be turned upside down manually or by a control signal from the control device 66. By turning the pipette 110 upright in advance, a smooth transition can be made to the dilution step and the administration preparation step, which will be described later.
[0077] 3, the dilution process is a process in which a priming solution is introduced into the pipette 110, thereby diluting the heparin introduced into the pipette 110 with the priming solution within the pipette 110. Note that if it is not necessary to dilute the heparin, the dilution process can be omitted and the process can proceed to the administration preparation process described below.
[0078] <Dilution Step 1> FIG. 3(a) shows the first step of the dilution step.
[0079] The processor of the control device 66 outputs a control signal to close the drug solution clamping means 120 (black). The processor of the control device 66 outputs a control signal to drive the blood pump 50, thereby rotating the rotor (not shown) of the blood pump 50 in the forward direction and introducing the priming solution into the arterial blood circuit 30. Note that the forward rotation is the direction in which the liquid flows from the arterial blood circuit 30 to the venous blood circuit 40. The reverse rotation (counter-rotation) is the direction in which the liquid flows from the venous blood circuit 40 to the arterial blood circuit 30. For example, a priming solution bag containing the priming solution is connected to the arterial blood circuit 30 (not shown). The blood pump 50 guides the priming solution from the priming solution bag to the arterial blood circuit 30, thereby delivering the priming solution to the arterial blood circuit 30. After the desired amount of priming solution has been delivered to the arterial blood circuit 30, the blood pump 50 is stopped.
[0080] <Dilution Step 2> FIG. 3(b) shows the second step of the dilution step.
[0081] The processor of the control device 66 outputs a control signal to maintain the closed state (black) of the chemical solution clamping means 120. The processor of the control device 66 outputs a control signal to drive the liquid level adjustment pump 140 to suck the diaphragm 131 of the diaphragm pump 130. Note that during the dilution step 2, the blood pump 50 is stopped.
[0082] <Dilution Step 3> FIG. 3(c) shows the final step of the dilution step.
[0083] When the blood pump 50 is operating, the processor of the control device 66 outputs a control signal to stop the blood pump 50 and close the arterial clamping means 36. The processor of the control device 66 outputs a control signal to open the medical solution clamping means 120 (white).
[0084] The processor of the control device 66 outputs a control signal to drive the liquid level adjustment pump 140 to press the diaphragm 131 of the diaphragm pump 130. This creates a positive pressure state in the arterial blood circuit 30. As the arterial blood circuit 30 becomes a positive pressure state, the priming solution introduced into the arterial blood circuit 30 is pushed toward the pipette 110 and introduced into the pipette 110 via the liquid drug line 100.
[0085] An amount of priming solution corresponding to the difference between the deformation due to pressure of the diaphragm 131 of the diaphragm pump 130 and the deformation due to suction is introduced into the pipette 110. By operating the diaphragm 131 of the diaphragm pump 130 at least once, a desired amount of priming solution can be introduced from the arterial blood circuit 30 into the pipette 110.
[0086] In this way, the heparin contained in the pipette 110 can be diluted with the priming solution within the pipette 110. Hereinafter, the heparin diluted with the priming solution will be referred to as diluted heparin.
[0087] The liquid level detector 150 detects the amount of diluted heparin stored in the pipette 110. A detection signal indicating the amount of diluted heparin is sent to the processor of the control device 66. The processor of the control device 66 can determine whether the desired amount of diluted heparin has been stored in the pipette 110. The processor of the control device 66 can calculate the concentration of the diluted heparin.
[0088] <<Administration Preparation Process>> As shown in Fig. 4, the administration preparation process is a process that makes it possible to administer undiluted heparin or diluted heparin in the pipette 110 to a patient. Note that during the administration preparation process, the blood pump 50 is stopped. If the heparin needs to be diluted, the process shifts from the dilution process to the administration preparation process. If the heparin does not need to be diluted, the process immediately shifts from the filling process to the administration preparation process.
[0089] <Administration Preparation Step 1> FIG. 4(a) shows the first step of the administration preparation step.
[0090] The processor of the control device 66 outputs a control signal to close (black) the chemical solution clamping means 120. The processor of the control device 66 outputs a control signal to drive the liquid level adjustment pump 140 to press the diaphragm 131 of the diaphragm pump 130.
[0091] <Administration Preparation Step 2> FIG. 4(b) shows the final step of the administration preparation step.
[0092] When the blood pump is operating, the processor of the control device 66 outputs a control signal to stop the blood pump and close the arterial clamping means 36 (black). The processor of the control device 66 outputs a control signal to open the drug solution clamping means 120 (white). The processor of the control device 66 outputs a control signal to drive the liquid level adjustment pump 140 and suck the diaphragm 131 of the diaphragm pump 130. This creates a negative pressure in the pipette 110 and the arterial blood circuit 30. The negative pressure in the pipette 110 and the arterial blood circuit 30 causes the diluted heparin contained in the pipette 110 to be sucked out of the pipette 110 and introduced into the arterial blood circuit 30 via the drug solution line 100.
[0093] An amount of diluted heparin corresponding to the difference between the deformation due to pressure of the diaphragm 131 of the diaphragm pump 130 and the deformation due to suction flows through the drug solution line 100 and is delivered to the arterial blood circuit 30. By operating the diaphragm 131 of the diaphragm pump 130 at least once, a desired amount of diluted heparin can be delivered to the arterial blood circuit 30.
[0094] In this way, the filling step, dilution step, and administration preparation step described above allow the heparin to be diluted with the priming solution in the pipette 110, making it possible to administer a desired amount of diluted heparin to a patient. Note that if the heparin is not diluted with the priming solution, the filling step and administration preparation step described above allow the desired amount of undiluted heparin to be administered to a patient.
[0095] <<Medicinal Solution Supplying Device 10A According to First Embodiment, Filling Step, Dilution Step, and Administration Preparation Step>> According to the medical solution supplying device 10A according to the first embodiment, the diaphragm pump 130 and the liquid level adjustment pump 140 provided in the blood circuit can be used to introduce heparin into the pipette 110, introduce a priming solution into the pipette 110, and deliver diluted heparin to the arterial blood circuit 30. The diaphragm pump 130 and the liquid level adjustment pump 140 can be effectively used in the filling step, dilution step, and administration preparation step.
[0096] The diaphragm pump 130, the liquid level adjustment pump 140, and other components can be controlled by the control device 66 of the dialysis machine main body 60, so the heparin dilution and administration preparation processes can be automated, improving the reproducibility of the dilution concentration using the priming solution and enabling stable execution. Automation also simplifies the process and reduces the burden on the user. Furthermore, the filling process, dilution process, and administration preparation process, or the filling process and administration preparation process, can be executed continuously.
[0097] The pipette 110 also has an extension 113 that is thinner than the container 112. This makes it easier to insert and remove the extension 113 from the opening of a container such as a vial that contains heparin. In this way, heparin can be introduced into the pipette 110 without being affected by the shape and size of the container or opening. The user can use the heparin they desire. The heparin contained in the container can be used across multiple treatments. There is no need to administer heparin using a syringe, which reduces treatment costs.
[0098] The pipette 110 can be used not only to introduce and store heparin, but also to introduce and store a priming solution and to dilute heparin, thereby enabling effective use of the pipette 110 and reducing the number of components. Furthermore, by introducing a priming solution into the pipette 110, the heparin in the pipette 110 can be simultaneously diluted, simplifying the dilution process.
[0099] By using the flexible drug solution line 100, the pipette 110 and the like can be placed at a location separated from the blood circuit, which increases the degree of freedom in the placement of the pipette 110 and the like. The pipette 110 and the like can be placed so as not to interfere with other devices, which improves the user's operability.
[0100] The drug solution line 100 is shared by both the dilution process in which the priming solution is introduced from the arterial blood circuit 30 to the pipette 110, and the administration preparation process in which diluted heparin is delivered from the pipette 110 to the arterial blood circuit 30, thereby reducing the number of components and simplifying the configuration.
[0101] <<<<<Second Embodiment>>>>> Figure 5 is a schematic diagram showing the filling process in a drug solution supplying device 10B according to a second embodiment. In the second embodiment, the drug solution supplying device 10B is also connected to a blood purification device 70 and applied to a hemodialysis device. In the second embodiment, the blood purification device 70 has the same configuration as that of the first embodiment, except that it does not have a diaphragm pump 130 or a liquid level adjustment pump 140. In the second embodiment, the same components as those in the first embodiment are denoted by the same reference numerals. In Figure 5, the dialysis device main body 60 and the control device 66 are omitted.
[0102] <<<Configuration of Blood Purification Apparatus 70>>> The blood purification apparatus 70 of the second embodiment mainly comprises: a dialyzer 20 having a blood purification function, a blood circuit to which an arterial blood circuit 30 and a venous blood circuit 40 are connected, a blood pump 50, a dialysis apparatus main body 60 (not shown) to which a dialysate inlet line 62 and a dialysate outlet line 64 are connected, a control device 66 (not shown), a drug solution clamping means 120, a liquid level detection device 150, and a drip sensor 220. The blood purification apparatus 70 of the second embodiment differs from the blood purification apparatus 70 of the first embodiment in that it comprises the drip sensor 220 but does not comprise the diaphragm pump 130 or the liquid level adjustment pump 140.
[0103] <<<Configuration of the drug solution supplying device 10B>>> The drug solution supplying device 10B can be provided outside the blood circuit, and can be used with minimal changes to the existing blood circuit.
[0104] 5, the chemical solution supplying device 10B mainly includes a chemical solution line 200, a pipette 110, and a dripping chamber 210. The pipette 110 has the same configuration and functions as that of the first embodiment.
[0105] <<Medicine Solution Line 200>> The medicine solution line 200 is connected to the blood circuit. A liquid can flow between the medicine solution line 200 and the blood circuit. The liquid can be, but is not limited to, a priming solution or diluted heparin. For example, the medicine solution line 200 is connected to and communicates with the arterial blood circuit 30. The medicine solution line 200 is preferably made of a flexible tube or the like. The pipette 110 can be positioned at a distance from the arterial blood circuit 30.
[0106] The drug solution line 200 is connected to the arterial blood circuit 30 at a connector 280. The drug solution line 200 is preferably detachably connected at the connector 280. Like the drug solution line 100, the drug solution line 200 can be used as a disposable device.
[0107] <Drip chamber 210> The drip chamber 210 separates a continuously flowing liquid into independent droplets and drips them by gravity. The drip chamber 210 is a component used in so-called intravenous drips. Specifically, the drip chamber 210 drips undiluted heparin or diluted heparin in droplet form. Details will be described later.
[0108] <Drip sensor 220> The drip sensor 220 detects the number of drops dispensed in the drip chamber 210 (hereinafter referred to as the drip number) and outputs a detection signal indicating the drip number to the dialysis machine. The control device 66 of the dialysis machine main body 60 can execute processing based on the drip number. The control device 66 of the dialysis machine main body 60 has the same configuration and functions as in the first embodiment. The control device 66 outputs control signals for controlling various control devices, and also receives detection signals indicating the results detected by various detection devices.
[0109] In the second embodiment, drip sensor 220 is detachably provided in drip chamber 210, but this is not limiting. Drip sensor 220 may be configured as an integral part of drip chamber 210. Drip sensor 220 may be any sensor that can detect the number of drops in drip chamber 210 and output a detection signal.
[0110] <<Other Configurations of Drug Solution Supplying Apparatus 10B>> The blood purification apparatus 70 of the second embodiment mainly includes a dialyzer 20 having a blood purification function, a blood circuit to which an arterial blood circuit 30 and a venous blood circuit 40 are connected, a blood pump 50, a dialysis apparatus main body 60 to which a dialysate inlet line 62 and a dialysate outlet line 64 are connected, a control device 66, drug solution clamping means 120, a liquid level detection device 150, and a drip sensor 220. The drug solution supplying apparatus 10B mainly includes a drug solution line 200, a pipette 110, and a drip chamber 210.
[0111] The configuration is not limited to this, and at least one of the liquid medicine clamping means 120, the liquid level detection device 150, and the drip sensor 220 may be included in the liquid medicine supplying device 10B. For example, a control device (not shown) having a processor (processing device) or the like may be provided in the liquid medicine supplying device 10B so that control signals can be output from the control device and detection signals can be input to the control device. Furthermore, the control device of the liquid medicine supplying device 10B is connected to the control device 66 of the blood purification device 70 so that they can communicate with each other. Of the liquid medicine clamping means 120, the liquid level detection device 150, and the drip sensor 220, those controlled by the control device 66 of the blood purification device 70 and those controlled by the control device of the liquid medicine supplying device 10B are appropriately divided and controlled.
[0112] Alternatively, only the control device of the chemical solution supplying device 10B may control all of the chemical solution clamping means 120, the liquid level detection device 150, and the drip sensor 220. The chemical solution clamping means 120 is controlled by a control signal output from the control device of the chemical solution supplying device 10B, and the detection signals output from the liquid level detection device 150 and the drip sensor 220 are input to the control device of the chemical solution supplying device 10B.
[0113] <<Processing by Medical Solution Supplying Device 10B>> When heparin is diluted with a priming solution, the processing by medical solution supplying device 10B also includes a filling step, a dilution step, and an administration preparation step. When heparin is not diluted with a priming solution, the processing by medical solution supplying device 10B includes the filling step and the administration preparation step. Note that Figure 5 shows the dilution step (a) and the administration preparation step (b).
[0114] In Fig. 5, valves shown in white indicate an open state, and valves shown in black indicate a closed state. In Fig. 5, the presence of heparin is indicated by diagonal lines, and the presence of priming solution is indicated by horizontal lines.
[0115] <<Filling Step>> In the second embodiment, unlike the first embodiment, heparin is introduced into the pipette 110 by an operator (manually) (see FIG. 2).
[0116] 5A, the dilution process is a process in which a priming solution is introduced into the pipette 110, thereby diluting the heparin introduced into the pipette 110 with the priming solution within the pipette 110. Note that if it is not necessary to dilute the heparin, the dilution process can be omitted and the process can proceed directly to the administration preparation process described below.
[0117] In the second embodiment, unlike the first embodiment, the blood pump 50 is rotated in reverse to introduce the priming solution from the arterial blood circuit 30 into the pipette 110. The blood pump 50 can be rotated in reverse by a control signal from the control device 66. The liquid level detection device 150 can determine whether the priming solution in the pipette 110 has reached the required amount.
[0118] Drip chamber 210 is placed upside down. Drip chamber 210 may be turned upside down manually or by a control signal from control device 66. By providing drip chamber 210 with a driving device (not shown) such as a motor, pipette 110 can be turned upside down by a control signal output from control device 66.
[0119] The operation of inverting drip chamber 210 may be performed manually or by using a driving device such as a motor (not shown). Control device 66 of blood purification device 70 outputs a control signal to a driving device such as a motor to invert drip chamber 210 upside down. When control device 66 of blood purification device 70 outputs an upright command signal, drip chamber 210 is turned upright by a driving device such as a motor. By outputting the upright command signal, control device 66 can determine that drip chamber 210 is in the upright state. When control device 66 of blood purification device 70 outputs an inverted command signal, drip chamber 210 is turned upside down by a driving device such as a motor. By outputting the inverted command signal, control device 66 can determine that drip chamber 210 is in the inverted state.
[0120] A sensor (not shown) may also be provided to detect whether drip chamber 210 is in an upright or inverted state. The sensor may be optical, mechanical, or another detection method, as long as it detects whether drip chamber 210 is in an upright or inverted state and outputs a signal indicating the detection result. Control device 66 of blood purification device 70 can obtain the state of drip chamber 210 by receiving the signal indicating the detection result from the sensor. Even if a malfunction occurs in a driving device such as a motor, the state of drip chamber 210 can be accurately obtained.
[0121] Furthermore, when the operator manually turns drip chamber 210 upside down, the operator operates the touch panel after completing the upside-down operation. For example, when the operator turns drip chamber 210 upright, the operator inputs information indicating that the touch panel has been turned upright. This operation causes the touch panel to output a signal indicating that the upright state has been reached to the control device. This allows control device 66 to determine that drip chamber 210 is in the upright state. On the other hand, when the operator turns drip chamber 210 upside down, the operator inputs information indicating that the touch panel has been turned upside down. This operation causes the touch panel to output a signal indicating that the inverted state has been reached to the control device. This allows control device 66 to determine that drip chamber 210 is in the inverted state.
[0122] Pipette 110 may be disposed so as to always be positioned above drip chamber 210, whether drip chamber 210 is in an upright position (upside down) or an inverted position.
[0123] When the blood pump 50 is operating, the processor of the control device 66 outputs a control signal to stop the blood pump 50 and to close (black) the arterial clamping means 36. The processor of the control device 66 outputs a control signal to open (white) the medical solution clamping means 120.
[0124] The processor of the control device 66 outputs a control signal to drive the blood pump 50. By driving the blood pump 50, the priming solution introduced into the arterial blood circuit 30 is pushed out, flows through the drug solution line 200, and is introduced into the pipette 110 via the drug solution clamping means 120 and the drip chamber 210. In this way, the priming solution can be introduced into the pipette 110.
[0125] An amount of priming solution corresponding to the amount of driving of the blood pump 50 is introduced into the pipette 110. In this way, the heparin introduced into the pipette 110 can be diluted with the priming solution within the pipette 110. In the second embodiment, as in the first embodiment, the heparin diluted with the priming solution is referred to as diluted heparin.
[0126] The liquid level detector 150 detects the amount of diluted heparin stored in the pipette 110. A detection signal indicating the amount of diluted heparin is transmitted to the processor of the control device 66. The processor of the control device 66 can determine whether the desired amount of undiluted or diluted heparin has been stored in the pipette 110. The processor of the control device 66 can calculate the concentration of the diluted heparin.
[0127] <<Administration Preparation Step>> As shown in FIG. 5B, the administration preparation step is a step of preparing the undiluted heparin or diluted heparin in the pipette 110 to be administered to a patient.
[0128] The drip chamber 210 is turned upside down and returned to its original state. The upside-down turning of the drip chamber 210 may be performed manually or by a control signal from the control device 66.
[0129] The processor of the control device 66 outputs a control signal to drive the blood pump 50. By rotating the rotor (not shown) of the blood pump 50 in the forward direction, diluted heparin corresponding to the amount by which the blood pump 50 is driven flows through the drug solution line 200 and is delivered to the arterial blood circuit 30.
[0130] The drip sensor 220 detects a drop of heparin each time undiluted heparin or diluted heparin is dripped in the drip chamber 210. The drip sensor 220 outputs a detection signal indicating that a drop has been dripped to the control device 66. By receiving the detection signal, the control device 66 counts the number of drops of undiluted heparin or diluted heparin and can calculate the total amount of undiluted heparin or diluted heparin administered. The control device 66 executes processing based on the total amount of undiluted heparin or diluted heparin. The volume of one drop of undiluted heparin or diluted heparin is measured in advance and stored in the RAM of the control device 66, for example.
[0131] <<Medicinal Solution Supplying Device 10B According to Second Embodiment, Filling Step, Dilution Step, and Administration Preparation Step>> According to the medical solution supplying device 10B according to the second embodiment, the blood pump 50 provided in the blood circuit can be used to introduce the priming solution into the pipette 110 and to deliver diluted heparin to the arterial blood circuit 30. The blood pump 50 can be effectively used in the dilution step and administration preparation step.
[0132] According to the liquid medicine supplying device 10B of the second embodiment, heparin can be diluted in the pipette 110 and undiluted heparin or diluted heparin can be administered with a simple configuration without using the diaphragm pump 130 or the liquid level adjustment pump 140 of the first embodiment. The dilution process and the administration preparation process can be performed without being limited by the configuration of the blood circuit.
[0133] According to the medicinal solution supplying device 10B of the second embodiment, undiluted heparin or diluted heparin can be measured in the administration preparation process using the drip chamber 210 and the drip sensor 220. As long as it can be linked to the dialysis device main body 60, it can be configured using components that are used in dialysis treatment. That is, in dialysis treatment, devices, parts, components, etc. are used so that the control device 66 of the blood purification device 70 receives a detection signal output from the drip sensor 220 and controls the blood pump 50 based on the number of drips. These devices, parts, components, etc. can be effectively used to configure the medicinal solution supplying device 10B of the second embodiment.
[0134] The pipette 110 can be used not only to introduce and store heparin, but also to introduce and store a priming solution and to dilute heparin, thereby enabling effective use of the pipette 110 and reducing the number of components. Furthermore, by introducing a priming solution into the pipette 110, the heparin in the pipette 110 can be simultaneously diluted, simplifying the dilution process.
[0135] By using the flexible drug solution line 200, the pipette 110 and other devices can be placed at a location away from the blood circuit, which increases the degree of freedom in the placement of the pipette 110 and other devices. The pipette 110 and other devices can be placed so as not to interfere with other devices, which improves the user's workability.
[0136] The drug solution line 200 is shared by both the dilution process in which the priming solution is introduced from the arterial blood circuit 30 to the pipette 110, and the administration preparation process in which diluted heparin is delivered from the pipette 110 to the arterial blood circuit 30, thereby reducing the number of components and simplifying the configuration.
[0137] <<<<<Third Embodiment>>>>> Figure 6 is a schematic diagram showing the configuration of a drug solution supplying device 10C according to a third embodiment. Like the drug solution supplying device 10A of the first embodiment, the drug solution supplying device 10C of the third embodiment is connected to a blood purification device 70 and applied to a hemodialysis device. In the third embodiment, the same components as those in the first embodiment are denoted by the same reference numerals.
[0138] In the third embodiment, the blood purification device 70 mainly includes a dialyzer 20 having a blood purification function, a blood circuit to which an arterial blood circuit 30 and a venous blood circuit 40 are connected, a blood pump 50, a dialysis device main body 60 (not shown) to which a dialysate inlet line 62 and a dialysate outlet line 64 are connected, a control device 66 (not shown), a diaphragm pump 330, a liquid level adjustment pump 340, a solenoid valve 370, an extension 313, a liquid level detection device 150, and a drug solution clamping means 320. Note that the dialysis device main body 60 and the control device 66 are omitted in FIG. 6 . The control device 66 of the dialysis device main body 60 has the same configuration and functions as those in the first and second embodiments. The control device 66 outputs control signals for controlling various control devices, and also receives detection signals indicating the results detected by various detection devices.
[0139] <Diaphragm Pump 330> The diaphragm pump 330 has a deformable diaphragm 331. The diaphragm pump 330 controls the flow of liquid by deformation of the diaphragm 331. The diaphragm 331 of the diaphragm pump 330 is driven by the liquid level adjustment pump 340. The diaphragm pump 330 presses or sucks the diaphragm 331 by the liquid level adjustment pump 340. The diaphragm 331 is deformed by pressing or sucking the diaphragm 331, generating negative pressure in the arterial blood circuit 30 or the venous blood circuit 40, thereby controlling the flow of liquid in the arterial blood circuit 30 or the venous blood circuit 40. The diaphragm pump 330 can repeatedly press and suck by the liquid level adjustment pump 340.
[0140] The diaphragm pump 330 does not come into contact with blood, and therefore can be reused multiple times as a component of the blood purification device 70.
[0141] <Liquid Level Adjustment Pump 340> The liquid level adjustment pump 340 deforms the diaphragm 331 of the diaphragm pump 330. The liquid level adjustment pump 340 presses or sucks the diaphragm 331 of the diaphragm pump 330.
[0142] The liquid level adjustment pump 340 has a driving device (not shown) such as a solenoid or a motor. The driving device of the liquid level adjustment pump 340 is driven by a control signal output from the control device 66, and the liquid level adjustment pump 340 performs pressure or suction.
[0143] <Solenoid Valve 370> The solenoid valve 370 is operated by a solenoid (not shown). The control device 66 outputs a control signal for controlling the solenoid. The control signal output from the control device 66 controls the solenoid, and the solenoid valve 370 is opened or closed. When the solenoid valve 370 is opened (shown in white), the pipette 310 communicates with the outside, and air inside the pipette 310 can be discharged to the outside in response to the operation of the diaphragm pump 330. When the solenoid valve 370 is closed (shown in black), the pipette 310 is no longer connected to the outside, and air cannot flow between the pipette 310 and the outside, even when the diaphragm pump 330 is operated.
[0144] <Extending portion 313> The extending portion 313 has a long, substantially cylindrical shape. The extending portion 313 extends from an upper portion of the accommodating portion 312 in a direction away from the accommodating portion 312. The extending portion 313 has a smaller diameter than the accommodating portion 312. The extending portion 313 is arranged concentrically with the accommodating portion 312. In other words, the extending portion 313 is arranged so that the central axis of the extending portion 313 coincides with the central axis of the accommodating portion 312. The extending portion 313 communicates with the outside.
[0145] A diaphragm pump 330 and a solenoid valve 370 are connected to the extension portion 313. By controlling the diaphragm pump 330 and the solenoid valve 370, air inside the storage portion 312 can be discharged to the outside, and heparin and a priming solution can be introduced into the pipette 310. Details will be described later.
[0146] <<<Configuration of the drug solution supplying device 10C>>> The drug solution supplying device 10C can be provided outside the blood circuit, and can be used with minimal changes to the existing blood circuit.
[0147] As shown in FIG. 6, the chemical solution supplying device 10C mainly includes a chemical solution line 300 and a pipette 310.
[0148] <<Medicine Solution Line 300>> The medicine solution line 300 is connected to the blood circuit. A liquid can flow between the medicine solution line 300 and the blood circuit. The liquid can be, but is not limited to, a priming solution or diluted heparin. For example, the medicine solution line 300 is connected to and communicates with the arterial blood circuit 30. The medicine solution line 300 is preferably composed of a flexible tube or the like. The pipette 310 can be positioned at a location remote from the arterial blood circuit 30.
[0149] The drug solution line 300 is connected to the arterial blood circuit 30 at a connector 380. The drug solution line 300 is preferably detachably connected at the connector 380. Like the drug solution lines 100 and 200, the drug solution line 300 can be used as a disposable device.
[0150] <<Pipette 310>> As in the first and second embodiments, heparin and a priming solution are introduced into the pipette 310. In the third embodiment, too, the heparin is diluted with the priming solution within the pipette 310.
[0151] The pipette 310 has an elongated shape overall. The pipette 310 is arranged so that the longitudinal direction is along the vertical direction. Unlike the first embodiment, the pipette 310 does not need to be turned upside down.
[0152] The pipette 310 mainly includes a housing 312 , an upper opening 314 , a first lower opening 316 and a second lower opening 318 .
[0153] <Storage section 312> The storage section 312 has a long, approximately cylindrical shape. Heparin and a priming solution are introduced into the storage section 312. In the storage section 312, the heparin is diluted with the priming solution. Furthermore, if the priming solution is not introduced into the storage section 312, the heparin is not diluted with the priming solution in the storage section 312, and the storage section 312 simply contains heparin.
[0154] <Upper end opening 314> The pipette 310 has an upper end opening 314 at its top. The upper end opening 314 is connected to an extension portion 313. The extension portion 313 communicates with the outside, and air can be discharged from the storage portion 312 to the outside via the upper end opening 314 and the extension portion 313.
[0155] <Extension Portion 315> The extension portion 315 has a long, substantially cylindrical shape. The extension portion 315 extends from the lower portion of the storage portion 312 in a direction (downward) away from the storage portion 312. The extension portion 315 has a smaller diameter than the storage portion 312. By making the extension portion 315 thinner than the storage portion 312, the extension portion 315 can be inserted into and removed from the openings of various containers. Heparin stored in containers of various shapes and sizes can be introduced into the storage portion 312. In particular, the extension portion 315 is preferably formed so as to become thinner (tapered) as it moves away from the storage portion 312. This makes it easier to insert and remove the extension portion 315 from and into the openings of various containers.
[0156] <First Lower End Opening 316> The extension portion 315 has a first lower end opening 316 at its lower end (the portion farthest from the storage portion 312). The first lower end opening 316 communicates with the storage portion 312 and the extension portion 315. The first lower end opening 316 can be connected to a vial (see FIG. 7). Heparin stored in a vial is introduced into the storage portion 312 from the first lower end opening 316 through the extension portion 315.
[0157] <Second Lower End Opening 318> The pipette 310 has a second lower end opening 318 at its bottom. The second lower end opening 318 communicates with the storage unit 312. The pipette 310 is connected to the liquid medicine line 300 at the second lower end opening 318. The priming solution is introduced into the storage unit 312 from the second lower end opening 318 via the liquid medicine line 300. Furthermore, heparin diluted with the priming solution is discharged from the storage unit 312 to the liquid medicine line 300 via the second lower end opening 318. Furthermore, when the heparin is not diluted with the priming solution, the priming solution is not introduced into the storage unit 312, and undiluted heparin is discharged from the storage unit 312 to the liquid medicine line 300 via the second lower end opening 318.
[0158] <Chemical liquid clamping means 320> The chemical liquid clamping means 320 is provided on the chemical liquid line 300. The chemical liquid clamping means 320 is in either an open state or a closed state. When the chemical liquid clamping means 320 is in the open state, the liquid can flow within the chemical liquid line 300. When the chemical liquid clamping means 320 is in the closed state, the liquid cannot flow within the chemical liquid line 300.
[0159] The chemical solution clamping means 320 has a driving device (not shown) such as a solenoid or a motor. The driving device is driven by a control signal output from the control device 66, and the chemical solution clamping means 320 is set to an open state or a closed state.
[0160] <<Other Configurations of the Drug Solution Supplying Device 10C>> In the third embodiment, an example was shown in which the blood purification device 70 mainly includes: a dialyzer 20 having a blood purification function; a blood circuit to which an arterial blood circuit 30 and a venous blood circuit 40 are connected; a blood pump 50; a dialysis device main body 60 to which a dialysate inlet line 62 and a dialysate outlet line 64 are connected; a control device 66; a diaphragm pump 330; a liquid level adjustment pump 340; a solenoid valve 370; an extension portion 313; and a liquid level detection device 150; and the drug solution supplying device 10C mainly includes: a drug solution line 300; and a pipette 310.
[0161] The configuration is not limited to this, and the liquid medicine supplying apparatus 10C may include at least one of the diaphragm pump 330, the liquid level adjustment pump 340, the solenoid valve 370, the extension portion 313, the liquid level detection device 150, and the liquid medicine clamping means 320. For example, the liquid medicine supplying apparatus 10C may be provided with a control device (not shown) having a processor (processing device) or the like, so that control signals can be output from the control device and detection signals from the liquid medicine clamping means 320 can be input to the control device. Furthermore, the control device of the liquid medicine supplying apparatus 10C is connected to the control device 66 of the blood purification apparatus 70 so that they can communicate with each other. Among the diaphragm pump 330, the liquid level adjustment pump 340, the solenoid valve 370, and the liquid medicine clamping means 320, those controlled by the control device 66 of the blood purification apparatus 70 and those controlled by the control device of the liquid medicine supplying apparatus 10C are appropriately divided and controlled.
[0162] Alternatively, only the control device of the chemical solution supplying apparatus 10C may control all of the diaphragm pump 330, the liquid level adjustment pump 340, the solenoid valve 370, and the chemical solution clamping means 320. The diaphragm pump 330, the liquid level adjustment pump 340, the solenoid valve 370, and the chemical solution clamping means 320 are controlled by control signals output from the control device of the chemical solution supplying apparatus 10C, and the detection signal output from the liquid level detection device 150 is input to the control device of the chemical solution supplying apparatus 10C.
[0163] <<Processing by Medical Solution Supply Apparatus 10C>> Fig. 7 is a schematic diagram showing a filling process by medical solution supply apparatus 10C according to the third embodiment. Fig. 8 is a schematic diagram showing a dilution process by medical solution supply apparatus 10C according to the third embodiment. Fig. 9 is a schematic diagram showing an administration preparation process by medical solution supply apparatus 10C according to the third embodiment. As shown in Figs. 7 to 9, the processing by medical solution supply apparatus 10C includes a filling process, a dilution process, and an administration preparation process when heparin is diluted with a priming solution. Furthermore, when heparin is not diluted with a priming solution, the processing by medical solution supply apparatus 10C includes a filling process and an administration preparation process.
[0164] 7 to 9, valves shown in white indicate that they are in an open state, and valves shown in black indicate that they are in a closed state. Furthermore, in Figures 7 to 9, the presence of heparin is indicated by diagonal lines, and the presence of priming solution is indicated by horizontal lines. A white arrow pointing left on the diaphragm pump 330 indicates that the diaphragm 331 is being pressed, and a white arrow pointing right on the diaphragm pump 330 indicates that the diaphragm 331 is being sucked.
[0165] <<Filling Process>> As shown in Figure 7, the filling process is a process of introducing heparin from a vial into the pipette 310. By using the filling process, heparin stored in a container such as a vial (such as the container in which it was delivered) can be introduced into the pipette 310. Heparin can be used regardless of the shape of the container in which it was delivered or the shape of the container, such as the opening of the container. This allows for compatibility with a wide variety of containers that can hold heparin. Note that the blood pump 50 is stopped during the filling process.
[0166] <Filling Step 1> Figure 7(a) shows the first step of the filling step. At this point, the liquid medicine clamping means 320, the solenoid valve 370, and the arterial clamping means 36 are all open (white). In the liquid medicine supplying device 10C, the arterial clamping means 36 is open (white) not only during the filling step, but also during the dilution step and the administration preparation step. The liquid medicine supplying device 10C does not need to include the arterial clamping means 36. If the liquid medicine supplying device 10C does not include the arterial clamping means 36, control of the arterial clamping means 36 can be omitted. Furthermore, if the liquid medicine supplying device 10C uses a system that includes the arterial clamping means 36, as shown in Figures 7 to 9, the arterial clamping means 36 can be controlled to always be open.
[0167] First, a vial containing heparin is placed below the pipette 310. Next, the first lower end opening 316 of the pipette 310 is inserted into the vial to communicate with the vial.
[0168] <Filling Step 2> FIG. 7B shows the second step of the filling step.
[0169] The processor of the control device 66 outputs a control signal to close (black) the chemical solution clamping means 320. The processor of the control device 66 outputs a control signal to open (white) the solenoid valve 370. The processor of the control device 66 outputs a control signal to drive the liquid level adjustment pump 140 and press the diaphragm 331 of the diaphragm pump 330.
[0170] <Filling Step 3> FIG. 7C shows the final step of the filling steps.
[0171] The processor of the control device 66 outputs a control signal to close the chemical solution clamping means 320 (black). The processor of the control device 66 outputs a control signal to close the solenoid valve 370 (black). The processor of the control device 66 outputs a control signal to drive the liquid level adjustment pump 140 and suck the diaphragm 331 of the diaphragm pump 330. This creates a negative pressure inside the pipette 310. When the negative pressure is created inside the pipette 310, the heparin contained in the vial is sucked out of the vial and introduced into the pipette 310.
[0172] An amount of heparin corresponding to the difference between the deformation due to pressure of diaphragm 331 of diaphragm pump 330 and the deformation due to suction is introduced into pipette 310. By deforming diaphragm 331 of diaphragm pump 330 at least once, a desired amount of heparin can be introduced from the vial into pipette 310.
[0173] By the filling process shown in FIGS. 7(a) to 7(c), heparin can be introduced into the pipette 110 regardless of the shape of the container in which the heparin is stored or the shape of the container, such as the opening.
[0174] 8, the dilution process is a process in which the priming solution is introduced into the pipette 310, thereby diluting the heparin introduced into the pipette 310 with the priming solution within the pipette 310. Note that the blood pump 50 is stopped during the dilution process. If it is not necessary to dilute the heparin, the dilution process can be omitted and the process can proceed to the administration preparation process described below.
[0175] <Dilution Step 1> FIG. 8(a) shows the first step of the dilution step.
[0176] The processor of the control device 66 outputs a control signal to close the chemical solution clamping means 320 (black). The processor of the control device 66 outputs a control signal to rotate the blood pump 50 forward, thereby introducing the priming solution into the arterial blood circuit 30. For example, a priming solution containing bag is connected to the arterial blood circuit 30 (not shown). The priming solution can be introduced into the arterial blood circuit 30 by using the blood pump 50 to guide the priming solution from the priming solution containing bag into the arterial blood circuit 30.
[0177] The pipette 310 is removed from the vial, and the first lower end opening 316 of the pipette 310 is sealed with a clamp 319. By sealing, the heparin introduced into the pipette 310 can be prevented from leaking out from the first lower end opening 316.
[0178] Alternatively, the pipette 310 may be provided with a driving device such as a motor, and a control signal issued from the control device 66 may be used to control the pipette 310 to be removed from the vial and clamp the first lower end opening 316 of the pipette 310.
[0179] <Dilution Step 2> FIG. 8(b) shows the second step of the dilution step.
[0180] The processor of the control device 66 outputs a control signal to close the chemical solution clamping means 320 (black), to open the solenoid valve 370 (white), and to drive the liquid level adjustment pump 140 to press the diaphragm 331 of the diaphragm pump 330.
[0181] <Dilution Step 3> FIG. 8(c) shows the final step of the dilution steps.
[0182] The processor of the control device 66 outputs a control signal to open the chemical solution clamping means 320 (white). The processor of the control device 66 outputs a control signal to close the solenoid valve 370 (black). The processor of the control device 66 outputs a control signal to drive the liquid level adjustment pump 140 and suck the diaphragm 331 of the diaphragm pump 330. This creates a negative pressure inside the pipette 310. With the negative pressure inside the pipette 310, the priming solution introduced into the arterial blood circuit 30 is sucked out and introduced into the pipette 310 via the chemical solution line 300.
[0183] An amount of priming solution corresponding to the difference between deformation due to pressure and deformation due to suction of the diaphragm 331 of the diaphragm pump 330 is introduced into the pipette 310. By deforming the diaphragm 331 of the diaphragm pump 330 at least once, a desired amount of priming solution can be introduced from the arterial blood circuit 30 into the pipette 310. By introducing the priming solution into the pipette 310, the heparin contained in the pipette 310 can be diluted with the priming solution within the pipette 310.
[0184] In the third embodiment, heparin diluted with the priming solution is also referred to as diluted heparin. As in the first embodiment, by providing the liquid level detection device 150 in the pipette 310, the processor of the control device 66 can determine whether the desired amount of undiluted heparin or diluted heparin has been stored in the pipette 310. The processor of the control device 66 can calculate the concentration of heparin.
[0185] <<Administration Preparation Step>> As shown in Fig. 9, the administration preparation step is a step of preparing undiluted heparin or diluted heparin in the pipette 310 to be administered to a patient. If the heparin needs to be diluted, the process moves from the dilution step to the administration preparation step. If the heparin does not need to be diluted, the process moves directly from the filling step to the administration preparation step.
[0186] 9A shows the first step of the administration preparation step. In administration preparation step 1, the blood pump 50 is stopped.
[0187] The processor of the control device 66 outputs a control signal to close the chemical solution clamping means 320 (black), to open the solenoid valve 370 (white), and to drive the liquid level adjustment pump 340 to suck the diaphragm 331 of the diaphragm pump 330.
[0188] <Administration Preparation Step 2> FIG. 9(b) shows the final step of the administration preparation step.
[0189] When the blood pump is operating, the processor of the control device 66 outputs a control signal to stop the blood pump and open the drug solution clamping means 320 (white). The processor of the control device 66 outputs a control signal to close the solenoid valve 370 (black). The processor of the control device 66 outputs a control signal to drive the liquid level adjustment pump 340 and press the diaphragm 331 of the diaphragm pump 330.
[0190] An amount of undiluted heparin or diluted heparin corresponding to the deformation of the diaphragm 331 of the diaphragm pump 330 is introduced into the arterial blood circuit 30. By operating the diaphragm 331 of the diaphragm pump 330 at least once, a desired amount of undiluted heparin or diluted heparin can be introduced into the arterial blood circuit 30. This allows a positive pressure state to be created inside the pipette 310. With the positive pressure state created inside the pipette 310, the undiluted heparin or diluted heparin introduced into the pipette 310 is introduced into the arterial blood circuit 30 via the drug solution line 300.
[0191] In this way, the heparin can be diluted with the priming solution in the pipette 310 and administered to the patient as undiluted or diluted heparin.
[0192] <<Medicinal Solution Supplying Device 10C According to Third Embodiment, Filling Step, Dilution Step, and Administration Preparation Step>> According to the medical solution supplying device 10C according to the third embodiment, the diaphragm pump 330 and the liquid level adjustment pump 340 can introduce heparin into the pipette 310, introduce a priming solution into the pipette 310, and deliver diluted heparin to the arterial blood circuit 30. The diaphragm pump 330 and the liquid level adjustment pump 340 are provided separately from the configuration of the blood circuit. Therefore, the filling step, dilution step, and administration preparation step can be performed without being limited by the configuration of the blood circuit.
[0193] The diaphragm pump 330, the liquid level adjustment pump 340, and other components can be controlled by the control device 66 of the dialysis device main body 60, so the heparin dilution and administration processes can be automated, improving the reproducibility of the dilution concentration using the priming solution and enabling stable execution. Automation also simplifies the process and reduces the burden on the user. Furthermore, the filling process, dilution process, and administration preparation process can be performed continuously.
[0194] The pipette 310 also has an extension 315 that extends away from the container 312. This allows the pipette 310 to be connected to a vial without having to be turned upside down, and allows heparin to be introduced into the container 312. In this way, the pipette 310 does not have to be turned upside down, which allows for a simple configuration.
[0195] The pipette 310 also has an extension 315 that is thinner than the container 312. This makes it easier to insert and remove the extension 315 from the opening of a container such as a vial that contains heparin. In this way, heparin can be introduced into the pipette 310 without being affected by the shape and size of the container or opening. The user can use the heparin they desire. The heparin contained in the container can be used across multiple treatments. There is no need to administer heparin using a syringe, which reduces treatment costs.
[0196] The pipette 310 can be used not only to introduce and store heparin, but also to introduce and store a priming solution and to dilute heparin, thereby enabling effective use of the pipette 310 and reducing the number of components. Furthermore, by introducing a priming solution into the pipette 310, the heparin in the pipette 310 can be simultaneously diluted, simplifying the dilution process.
[0197] By using the flexible drug solution line 300, the pipette 310 and other devices can be placed at a location away from the blood circuit, which increases the degree of freedom in the placement of the pipette 310 and other devices. The pipette 310 and other devices can be placed so as not to interfere with other devices, which improves the user's workability.
[0198] The drug solution line 300 is shared by both the dilution process in which the priming solution is introduced from the arterial blood circuit 30 to the pipette 310 and the administration preparation process in which diluted heparin is delivered from the pipette 310 to the arterial blood circuit 30, thereby reducing the number of components and simplifying the configuration.
[0199] <<<Modifications>>> In the third embodiment described above, an example was shown in which the blood purification apparatus 70 had the diaphragm pump 330, the liquid level adjustment pump 340, the solenoid valve 370, and the extension part 313. However, the medicinal solution supplying apparatus 10C may have the diaphragm pump 330 and the extension part 313. The diaphragm pump 330 and the liquid level adjustment pump 340 can be controlled by a control device (not shown) of the medicinal solution supplying apparatus 10C, rather than by the control device 66 of the blood purification apparatus 70.
[0200] The control device of the chemical solution supplying device 10C mainly includes a processor (such as a CPU (Central Processing Unit)), a ROM (Read Only Memory), a RAM (Random Access Memory), an I / O (Input / Output Interface), an I / F (Interface Device), an auxiliary storage device (such as a HDD (Hard Disk Drive) or an SSD (Solid State Drive)), and an input operation device (such as a touch panel or keyboard). The ROM stores programs and constants for executing various processes such as control processes. The RAM temporarily stores variable values used when a program is executed.
[0201] The control device of the chemical solution supplying device 10C outputs various control signals and inputs various detection signals via the I / O. For example, the control device outputs control signals to the liquid level adjustment pump 340, the solenoid valve 370, etc.
[0202] <<<Overall Processing of Control Device 66>>> Figure 11 is a flowchart showing the overall processing of control device 66. As described above, in drug solution supply devices 10A to 10C, the filling step, dilution step, and administration preparation step are sequentially executed under the control of control device 66. In particular, when it is not necessary to dilute the heparin, the operator can skip the dilution step and move from the filling step to the administration preparation step by operating the input unit (Figure 10).
[0203] The processor of the control device 66 executes the filling process (step S111).
[0204] If the heparin is to be diluted in step S113 (YES), the processor of the control device 66 executes the dilution step (step S115).
[0205] If the heparin is not diluted in step S113 (NO), or after the dilution step has been performed, the processor of the control device 66 performs an administration preparation step (step S117).
[0206] <<<<<Scope of the Embodiments>>>>> The first to third embodiments have been described above. However, the descriptions and drawings that form part of this disclosure should not be understood as limiting. Various embodiments not described herein are also included.
[0207] In the examples described in the first to third embodiments, heparin (unfractionated heparin) is used as an example of an anticoagulant, but it is not limited to unfractionated heparin, and low molecular weight heparin, argatroban, nafamostat mesilate, etc. can also be used. An appropriate agent can be selected and used depending on characteristics such as the process of action, half-life, and side effects.
[0208] <<<<Embodiments of the Invention>>>> <<First Aspect>> According to the first aspect of the drug solution supplying device, there is provided a drug solution supplying device that supplies a drug solution to a blood circuit (e.g., arterial blood circuit 30, venous blood circuit 40, etc.) of a blood purification device (e.g., dialysis device main body 60, etc.) that purifies blood, the drug solution supplying device comprising: a composition holding portion (e.g., pipette 110, pipette 310, etc.) into which an anticoagulant (e.g., heparin) contained in a container can be introduced from the container, and that holds a composition containing at least the introduced anticoagulant; and a connection portion (e.g., drug solution line 100, 200, 300, etc.) that connects the composition holding portion to the blood circuit, and enables the composition to be introduced from the composition holding portion to the blood circuit.
[0209] The drug solution supplying device is a device that supplies a drug solution to a blood circuit. A blood purification device that purifies blood has a blood circuit. The drug solution supplying device includes a composition holding portion and a connecting portion.
[0210] An anticoagulant can be introduced into the composition holding portion. That is, an anticoagulant can be introduced into the composition holding portion. The anticoagulant is contained in a container. The container is one that is commonly used to contain an anticoagulant. The container is one that is commonly distributed to contain an anticoagulant. The container has a shape, size, etc. suitable for containing an anticoagulant.
[0211] Being capable of being introduced means that the drug solution supply device of the first aspect includes not only a state in which an anticoagulant has been introduced into the composition holding section, but also preliminary and potential situations for introduction even when the anticoagulant has not been introduced into the composition holding section.
[0212] For example, even if the anticoagulant in the container and the composition holding portion are separated, the composition holding portion may inevitably come into contact with the anticoagulant in the container. Also, even if the anticoagulant in the container is in contact with the composition holding portion, the anticoagulant will not be introduced into the composition holding portion unless a driving portion such as a pump is driven. However, if the driving portion is driven, the anticoagulant will immediately be introduced into the composition holding portion. Such situations also fall under this category.
[0213] Thus, the term "introducible" is meant to include preliminary and potential situations in which the anticoagulant is introduced from the container into the composition holding portion.
[0214] The composition holding portion holds a composition. The composition includes at least an anticoagulant introduced into the composition holding portion. The composition may consist of only the anticoagulant, or may include other components.
[0215] The composition holding portion can be introduced with an anticoagulant and can hold a composition containing at least the introduced anticoagulant.
[0216] The connecting portion connects the composition holding portion to the blood circuit. The composition holding portion is connected to the blood circuit by the connecting portion. The connecting portion can lead the composition from the composition holding portion to the blood circuit. That is, the composition held in the composition holding portion can be led from the composition holding portion to the blood circuit via the connecting portion.
[0217] Being capable of being delivered means that the drug solution supply device of the first aspect includes not only a state in which the composition is being delivered to the blood circuit, but also a preliminary or potential state for delivery even when the composition is not being delivered to the blood circuit.
[0218] For example, even if the composition holding portion is disconnected from the blood circuit, the situation where the composition holding portion can necessarily be connected to the blood circuit is included. Also, even if the composition holding portion is connected to the blood circuit, the composition will not be delivered to the blood circuit unless components such as pumps and valves are in the delivery state. However, once the components are in the delivery state, the composition will be immediately delivered to the blood circuit. Such situations are included.
[0219] Thus, deliverable is meant to include preliminary and potential situations in which the composition is delivered to the blood circuit.
[0220] Since an anticoagulant contained in a commonly used or distributed container can be introduced into the composition holding section, it is possible to avoid transferring the anticoagulant to another container or discarding the anticoagulant, thereby preventing the process from becoming complicated and preventing the anticoagulant from being wasted.
[0221] <<Second Aspect>> The second aspect is the first aspect, further comprising: detecting the liquid level of the composition held in the composition holding portion using a liquid level detection device (e.g., liquid level detection device 150, etc.).
[0222] Since the liquid level of the composition is detected by the liquid level detection device, it is possible to obtain the amount of anticoagulant introduced into the composition holding section and the amount of composition remaining in the composition holding section, and it is possible to appropriately control the drug solution supplying device. The blood purification device may have the liquid level detection device, or the drug solution supplying device or another device may have the liquid level detection device. It is sufficient if the blood purification device, drug solution supplying device, etc. can be controlled based on the liquid level of the composition detected by the liquid level detection device.
[0223] <<Third Aspect>> The third aspect is the first or second aspect, further comprising: an empty detector (e.g., empty detector 160) that detects that the composition holding section has run out of the composition.
[0224] The empty detector can detect when the composition is empty, allowing appropriate determination of whether or not an anticoagulant can be introduced into the composition holding section, whether or not the delivery of the composition should be stopped, etc. The empty detector may be included in the blood purification device, or in the drug solution supply device or other device. It is sufficient that the blood purification device, drug solution supply device, etc. can be controlled based on the detection result detected by the empty detector.
[0225] <<Fourth Aspect>> The fourth aspect is any one of the first to third aspects, wherein a diluent (e.g., a priming solution) can be introduced into the composition holding portion, and the composition diluted with the introduced diluent can be held in the composition holding portion.
[0226] Not only an anticoagulant but also a diluent can be introduced into the composition holding section. By introducing a diluent into the anticoagulant introduced into the composition holding section, the anticoagulant can be diluted in the composition holding section, and the diluted anticoagulant can be held in the composition holding section as a composition.
[0227] Being capable of being introduced means that the fourth aspect of the drug solution supply device includes not only a state in which the diluent has been introduced into the composition holding section, but also a preliminary or potential state for introduction even when the diluent has not been introduced into the composition holding section.
[0228] For example, even if the composition holding portion is disconnected from the blood circuit, the situation where the composition holding portion can inevitably be connected to the blood circuit is included. Also, even if the composition holding portion is connected to the blood circuit, the diluent will not be introduced into the composition holding portion unless components such as pumps and valves are introduced. However, once the components are introduced, the diluent will be immediately introduced into the composition holding portion. Such situations are included.
[0229] Thus, the term "introducible" also includes preliminary and potential situations in which a diluent is introduced from the blood circuit into the composition holding portion.
[0230] The diluent can be introduced into the composition holding portion from the blood circuit via the connecting portion, for example. The route for introducing the diluent is not limited to this, and any route that can introduce the diluent into the composition holding portion may be used.
[0231] <<Fifth Aspect>> The fifth aspect is any of the first to fourth aspects, further comprising: a first communication portion (e.g., extension portion 113 or first lower end opening 316) that communicates between the container and the composition holding portion, and enables the anticoagulant contained in the container to be introduced into the composition holding portion; and a second communication portion (e.g., lower end opening 116 or second lower end opening 318) that communicates between the composition holding portion and the connecting portion, and enables the composition held in the composition holding portion to be led out to the connecting portion.
[0232] The chemical solution supplying device according to the fifth aspect includes a first communication part and a second communication part.
[0233] The first communication part communicates the container with the composition holding part. The first communication part allows the anticoagulant contained in the container to be introduced into the composition holding part. The anticoagulant contained in the container can be introduced into the composition holding part via the first communication part.
[0234] The meaning of "introducible" in the fifth aspect is the same as that of "introducible" in the first aspect.
[0235] The second communication portion communicates the composition holding portion with the connecting portion. The second communication portion enables the composition held in the composition holding portion to be delivered to the connecting portion. The composition held in the composition holding portion can be delivered to the connecting portion via the second communication portion.
[0236] The meaning of "derivable" in the fifth aspect is the same as that in the first aspect.
[0237] By providing separate paths for the anticoagulant to flow and the composition and diluent to flow, with the composition holding section sandwiched in between, the concentration, cleanliness, and other conditions of the anticoagulant contained in the container can be maintained constant.
[0238] <<Sixth Aspect>> The sixth aspect is any one of the first to fifth aspects, wherein the second communication portion has a diluent introduction state in which a diluent is introduced into the composition holding portion, and a composition discharge state in which the composition is discharged to the connecting portion.
[0239] The second communication section can be used in both the diluent introduction state and the composition discharge state. The diluent introduction state is a state in which the diluent is introduced into the composition holding section via the connecting section. The composition discharge state is a state in which the composition is discharged to the connecting section via the connecting section. By using the second communication section in common, the configuration can be simplified.
[0240] <<Seventh Aspect>> The seventh aspect is any one of the first to sixth aspects, wherein the blood circuit further includes a diaphragm pump (e.g., diaphragm pump 130, etc.) that controls the flow of liquid in the blood circuit by deformation of a diaphragm.
[0241] The flow of liquid in the blood circuit is controlled using a diaphragm pump in the blood circuit, so that the diluent can be introduced into the composition holding section and the composition can be discharged into the connecting section without the need for a separate drive device for controlling the flow of liquid. By sharing the diaphragm pump, the configuration of the drug solution supply device can be simplified.
[0242] <<Eighth Aspect>> The eighth aspect is any one of the first to seventh aspects, further comprising a drip chamber (e.g., drip chamber 210, etc.) that separates the continuously flowing composition into independent droplets and drips them by the action of gravity, and the composition dripped from the drip chamber is detected using a drip sensor (e.g., drip sensor 220, etc.).
[0243] Since the composition can be delivered from the composition holding section to the blood circuit using components that are regularly provided or commonly used in dialysis facilities, etc., the drug solution supplying device can be constructed easily and simply. The blood purification device may have a drip sensor, or the drug solution supplying device or another device may have a drip sensor. It is sufficient that the blood purification device, drug solution supplying device, etc., can be controlled based on the detection results detected by the drip sensor.
[0244] <<Ninth Aspect>> The ninth aspect is the same as any of the first to eighth aspects, wherein an extension portion (e.g., extension portion 313, etc.) spaced apart from the composition holding portion has a diaphragm pump (e.g., diaphragm pump 330, etc.) that controls the flow of air within the extension portion by deformation of a diaphragm.
[0245] Being capable of flowing means that the drug solution supply device of the ninth aspect includes not only a state in which air is flowing, but also a preliminary or potential state in which air is not flowing, in which the air is flowing.
[0246] For example, if a pump, valve, or other component is not enabled, air will not flow through the extension. However, if the component is enabled, air will immediately flow through the extension. This situation and others apply.
[0247] Thus, the term "allowing air to flow" also includes a preliminary or potential situation in which air can flow within the extension.
[0248] Even if the blood circuit does not have a driving device such as a diaphragm pump, by separately adding a diaphragm pump to the blood circuit, it can be configured to be able to introduce an anticoagulant, introduce a diluent, or extract a composition.
[0249] The extension may or may not be included in the drug solution supply device.
[0250] <<Tenth Aspect>> The tenth aspect is any one of the first to ninth aspects, wherein the first communicating portion has a protruding portion (e.g., extension portion 113, etc.) having a long cylindrical shape, and the protruding portion has an opening (e.g., upper end opening 114, etc.) that can be inserted into a through-hole of the container and is provided at the tip end farthest from the composition holding portion.
[0251] The first communication portion has a protruding portion protruding from the composition holding portion. The protruding portion has an opening. The opening is insertable into a through-hole of the container. The opening is provided at the tip end farthest from the composition holding portion.
[0252] Being insertable means that the drug solution supply device of the tenth aspect includes not only a state in which the opening is inserted into the through hole, but also a preliminary or potential state in which the opening is not inserted into the through hole, and thus is capable of insertion.
[0253] For example, this applies to a situation where the opening can be inserted into the through-hole even if the opening is separated from the through-hole.
[0254] Thus, the term "insertable" means that the opening is also in a preliminary or potential state for being inserted into the through-hole.
[0255] By positioning the protrusion inside the container via the through hole, the anticoagulant contained in the container can be immediately introduced into the composition holding portion via the opening, allowing the anticoagulant to be used without processing the container or transferring the anticoagulant to another container, simplifying the process.
[0256] The protruding portion preferably has an outer diameter that tapers with increasing distance from the composition holding portion, which allows it to accommodate various sizes of through-holes in containers and increases the types of containers that can be used with the first communicating portion.
[0257] <<Eleventh Aspect>> The eleventh aspect is a medicinal solution supplying method for supplying a medicinal solution to a blood circuit (e.g., arterial blood circuit 30 or venous blood circuit 40) of a blood purification apparatus (e.g., dialysis apparatus main body 60) that purifies blood, comprising: an anticoagulant introducing step of introducing an anticoagulant (e.g., heparin) contained in a container from the container to a composition holding section (e.g., pipette 110 or pipette 310); a composition holding step of holding a composition containing at least the anticoagulant introduced into the composition holding section in the composition holding section; and a composition delivering step of delivering the composition from the composition holding section to the blood circuit via a connecting section (e.g., medicinal solution line 100, 200, 300) that connects the composition holding section to the blood circuit.
[0258] Since an anticoagulant contained in a commonly used or distributed container can be introduced into the composition holding section, it is possible to avoid transferring the anticoagulant to another container or discarding the anticoagulant, thereby preventing the process from becoming complicated and preventing the anticoagulant from being wasted.
[0259] <<Twelfth Aspect>> The twelfth aspect is any one of the first to eleventh aspects, further including a composition liquid level detection step of detecting a liquid level of the composition held in the composition holding portion.
[0260] The liquid level of the composition is detected by the liquid level detection device, so that the amount of anticoagulant introduced into the composition holding section and the amount of composition remaining in the composition holding section can be obtained, and the drug solution supply device can be appropriately controlled.
[0261] <<Thirteenth Aspect>> A thirteenth aspect is the device according to any one of the first to twelfth aspects, further comprising an empty detection step of detecting that the composition holding section has run out of the composition.
[0262] The empty detection device can detect when the composition is empty, allowing appropriate decisions to be made as to whether or not it is appropriate to introduce anticoagulant into the composition holding section, or whether or not the discharge of the composition should be stopped.
[0263] <<Fourteenth Aspect>> The fourteenth aspect is any one of the first to thirteenth aspects, further including a diluent introduction step of introducing a diluent (e.g., a priming solution) into the composition holding section, and a dilution holding step of holding the composition diluted with the introduced diluent in the composition holding section.
[0264] Not only an anticoagulant but also a diluent can be introduced into the composition holding section. By introducing a diluent into the anticoagulant introduced into the composition holding section, the anticoagulant can be diluted in the composition holding section, and the diluted anticoagulant can be held in the composition holding section as a composition.
[0265] <<Fifteenth Aspect>> The fifteenth aspect is any of the first to fourteenth aspects, and further includes an introduction step of introducing an anticoagulant contained in a container into the composition holding portion via a first communication portion (e.g., extension portion 113 or first lower end opening 316) that communicates between the container and the composition holding portion, and a discharge step of discharging the composition held in the composition holding portion to the connecting portion via a second communication portion (e.g., lower end opening 116 or second lower end opening 318) that communicates between the composition holding portion and the connecting portion.
[0266] By providing separate paths for the anticoagulant to flow and the composition and diluent to flow, with the composition holding section sandwiched in between, the concentration, cleanliness, and other conditions of the anticoagulant contained in the container can be maintained constant.
[0267] <<16th Aspect>> The 16th aspect is any one of the first to fifteenth aspects, further including: a diluent introducing step of introducing a diluent into the composition holding portion via the second communication portion; and a composition discharging step of discharging the composition to the connecting portion via the second communication portion.
[0268] The second communication part can be used in both the diluent introduction step and the composition discharge step. The diluent introduction step is a step of introducing the diluent into the composition holding part via the connecting part. The composition discharge step is a step of discharging the composition into the connecting part via the connecting part. By using the second communication part in common, the configuration can be simplified.
[0269] <<17th Aspect>> The 17th aspect is any one of the first to sixteenth aspects, further including a liquid flow control step of controlling the flow of liquid in the blood circuit by deformation of a diaphragm of a diaphragm pump (e.g., diaphragm pump 130, etc.).
[0270] The flow of liquid in the blood circuit is controlled using a diaphragm pump in the blood circuit, so that the diluent can be introduced into the composition holding section and the composition can be discharged into the connecting section without the need for a separate drive device for controlling the flow of liquid. By sharing the diaphragm pump, the configuration of the drug solution supply device can be simplified.
[0271] <<Eighteenth Aspect>> The eighteenth aspect is the method according to any one of the first to seventeenth aspects, further including: a dripping step of separating the continuously flowing composition into independent droplets and dripping the droplets by the action of gravity; and a dropped composition detection step of detecting the dropped composition.
[0272] Since the composition can be delivered from the composition holding section to the blood circuit using components that are regularly available or commonly used in dialysis facilities, etc., the drug solution supply device can be constructed easily and simply.
[0273] <<19th Aspect>> The 19th aspect is any one of the first to eighteenth aspects, further including a liquid flow control step of controlling the flow of liquid in the extension portion by deformation of a diaphragm of a diaphragm pump (e.g., diaphragm pump 330, etc.) provided in an extension portion that is spaced apart from the composition holding portion and through which air can flow.
[0274] Even if the blood circuit does not have a driving device such as a diaphragm pump, by separately adding a diaphragm pump to the blood circuit, it can be configured to be able to introduce an anticoagulant, introduce a diluent, or extract a composition.
[0275] To provide a drug solution supplying device that is not limited to packaging materials for drug solutions such as heparin and can be used for multiple treatments with a single package of drug solution. CROSS-REFERENCE TO RELATED APPLICATIONS
[0276] This application claims priority based on Japanese Patent Application No. 2023-209695, filed with the Japan Patent Office on December 12, 2023, the entire disclosure of which is incorporated herein by reference in its entirety.
[0277] 10A, 10B, 10C: Drug solution supply device 20: Dialyzer 60: Dialysis device main body 70: Blood purification device 110: Pipette 130: Diaphragm pump 140: Liquid level adjustment pump
Claims
1. A drug solution supplying device that supplies a drug solution to a blood circuit of a blood purification device that purifies blood, comprising: a composition holding section that holds a composition containing at least the introduced anticoagulant, and into which an anticoagulant contained in a container can be introduced from the container; and a connecting section that connects the composition holding section to the blood circuit and enables the composition to be led out from the composition holding section to the blood circuit.
2. The chemical liquid supplying device according to claim 1, wherein the liquid level of the composition held in the composition holding portion is detected by a liquid level detection device.
3. The drug solution supplying device according to claim 1, further comprising an empty detector that detects when the composition holding section is empty of the composition.
4. The drug solution supplying device according to claim 1, wherein a diluent can be introduced into the composition holding portion, and the composition diluted with the introduced diluent can be held in the composition holding portion.
5. A drug solution supplying device as described in claim 1, further comprising: a first communication portion that communicates the container with the composition holding portion, the first communication portion enabling the anticoagulant contained in the container to be introduced into the composition holding portion; and a second communication portion that communicates the composition holding portion with the connecting portion, the second communication portion enabling the composition held in the composition holding portion to be drawn out to the connecting portion.
6. The drug solution supply device according to claim 5, wherein the second communication section has a diluent introduction state in which a diluent is introduced into the composition holding section, and a composition discharge state in which the composition is discharged into the connecting section.
7. The drug solution supplying device according to claim 1, wherein the blood circuit further comprises a diaphragm pump which controls the flow of liquid within the blood circuit by deformation of a diaphragm.
8. The drug solution supplying device of claim 1, further comprising a drip chamber which separates the continuously flowing composition into independent droplets and drips them by the action of gravity, and the composition dripped from the drip chamber is detected by a drip sensor.
9. The drug solution supplying device according to claim 1, wherein an extension spaced from said composition holding portion has a diaphragm pump which controls the flow of air within said extension portion by deformation of a diaphragm.
10. A drug solution supplying device as described in claim 5, wherein the first communicating portion has a protrusion having a long cylindrical shape, and the protrusion has an opening that can be inserted into a through hole of the container, and has an opening provided at the tip portion furthest from the composition holding portion.
11. A medicinal solution supplying method for supplying a medicinal solution to a blood circuit of a blood purification device that purifies blood, comprising: an anticoagulant introducing step of introducing an anticoagulant contained in a container from the container to a composition holding section; a composition holding step of retaining a composition containing at least the anticoagulant introduced into the composition holding section in the composition holding section; and a composition discharge step of discharging the composition from the composition holding section to the blood circuit via a connecting section that connects the composition holding section to the blood circuit.
12. The method for supplying a chemical solution according to claim 11, further comprising a composition liquid level detection step of detecting the liquid level of the composition held in the composition holding section.
13. The method for supplying a chemical solution according to claim 11, further comprising an empty detection step of detecting when the composition holding section is empty of the composition.
14. The method for supplying a chemical solution according to claim 11, further comprising: a diluent introduction step of introducing a diluent into the composition holding section; and a dilution holding step of holding the composition diluted with the introduced diluent in the composition holding section.
15. A method for supplying a medicinal solution as described in claim 11, further comprising: an introduction step of introducing an anticoagulant contained in a container into the composition holding portion via a first communication portion that communicates the container with the composition holding portion; and an extraction step of extracting the composition held in the composition holding portion to the connecting portion via a second communication portion that communicates the composition holding portion with the connecting portion.
16. The method of supplying a chemical solution as described in claim 15, further comprising: a diluent introduction step of introducing a diluent into the composition holding portion via the second communication portion; and a composition discharge step of discharging the composition to the connecting portion via the second communication portion.
17. The drug solution supply method according to claim 11, further comprising a liquid flow control step of controlling the flow of liquid in the blood circuit by deformation of a diaphragm of a diaphragm pump.
18. The drug solution supplying device according to claim 11, further comprising: a dripping step of separating the continuously flowing composition into independent droplets and dripping the droplets by the action of gravity; and a dripped composition detection step of detecting the dripped composition.
19. The method for supplying a chemical solution according to claim 11, further comprising a liquid flow control step of controlling the flow of air within the extension by deformation of a diaphragm of a diaphragm pump provided in an extension portion separated from the composition holding portion and through which air can flow.
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