Chemical liquid supply device, chemical liquid dilution method

Abstract

This invention provides a medication supply device that is not easily limited by the packaging materials of medications such as heparin and can use a single package of medication for multiple treatments. The medication supply device supplies medication to a blood circuit of a blood purification device for purifying blood. The medication supply device includes: a composition holding section capable of introducing an anticoagulant contained in a container from a container and holding a composition containing at least the introduced anticoagulant; and a connecting section connecting the composition holding section to the blood circuit, capable of exporting the composition from the composition holding section to the blood circuit.

Description

Technical Field

[0001] This invention relates to a drug supply device and a drug dilution method. Background Technology

[0002] Heparin is sometimes used as a blood anticoagulant in dialysis devices and the like. Typically, heparin is delivered in vials or similar containers. In systems using heparin contained in vials, heparin can be immediately accessed from the vials by attaching them to the device (see Patent Document 1).

[0003] Existing technical documents

[0004] Patent documents

[0005] Patent Document 1: Japanese Patent Application Publication No. 2021-118944 Summary of the Invention

[0006] The technical problem that the invention aims to solve

[0007] In existing systems, the medication vial is mounted onto the device. Therefore, only medication vials with a predetermined shape and size that are usable within the system can be used. Consequently, the packaging material for heparin is limited to medication vials. Furthermore, treatment can only be administered using a single unit of heparin, making it difficult to administer multiple treatments.

[0008] The present invention was made in view of the above-mentioned problems, and its object is to provide a drug supply device that is not easily limited by the packaging materials of drug solutions such as heparin, and can divide a single package of drug solution into multiple treatments.

[0009] Technical means for solving problems

[0010] The medicine supply device of the present invention is characterized in that:

[0011] A drug supply device supplies drug solution to a blood circuit of a blood purification device for purifying blood. The drug supply device comprises:

[0012] A composition holding section, capable of introducing an anticoagulant contained within a container from a container and holding a composition containing at least the introduced anticoagulant; and

[0013] A connecting portion that connects the composition holding portion to the blood circuit, enabling the composition to be exported from the composition holding portion to the blood circuit.

[0014] Invention Effects

[0015] It is not easily limited by the packaging materials of drugs such as heparin, and can divide the drug solution in a single package into multiple treatments. Attached Figure Description

[0016] Figure 1 This is a schematic diagram illustrating the structure of the liquid medicine supply device according to the first embodiment.

[0017] Figure 2 This is a schematic diagram illustrating the filling process in the liquid medicine supply device according to the first embodiment.

[0018] Figure 3 This is a schematic diagram illustrating the dilution process in the liquid supply device according to the first embodiment.

[0019] Figure 4 This is a schematic diagram illustrating the drug preparation process in the drug supply device according to the first embodiment.

[0020] Figure 5 This is a schematic diagram illustrating the dilution process (a) and the drug preparation process (b) in the drug supply device according to the second embodiment.

[0021] Figure 6 This is a schematic diagram illustrating the structure of the liquid medicine supply device according to the third embodiment.

[0022] Figure 7 This is a schematic diagram illustrating the filling process in the liquid medicine supply device according to the third embodiment.

[0023] Figure 8 This is a schematic diagram illustrating the dilution process in the liquid supply device according to the third embodiment.

[0024] Figure 9 This is a schematic diagram illustrating the drug preparation process in the drug supply device according to the third embodiment.

[0025] Figure 10 A functional block diagram illustrating the function of control device 66.

[0026] Figure 11 This is a flowchart illustrating the overall processing of the control device 66. Detailed Implementation

[0027] <<<<<Summary of this implementation method>>>>>

[0028] Previously, heparin was used as an anticoagulant in dialysis treatment. Heparin was mostly delivered in vials or filled into syringes.

[0029] When using heparin stored in vials, the vials are directly attached to the device for heparin administration. However, it is difficult to use packaging materials other than those compatible with the device's vials. Furthermore, with standard vials, the entire amount of heparin must be used in a single treatment, making it difficult to administer heparin in multiple treatments.

[0030] The size and shape of packaging materials such as medicine bottles are mostly limited by the equipment, resulting in a limited range of choices for usable packaging materials.

[0031] Therefore, in order to select the required heparin, it is desirable to develop a device and system that can broaden the range of packaging materials available and allow the packaging materials to be used multiple times.

[0032] <<<<<Detailed Description of This Implementation Method>>>>>

[0033] The first to third embodiments, which are implementation methods, will now be described with reference to the accompanying drawings.

[0034] <<Direction>>

[0035] <Upward, sideways, facing upward, above, etc.>

[0036] The upward direction is the opposite of the downward direction, which will be described later, and is the opposite of the direction of gravity.

[0037] <downward, lower side, facing downward, below, etc.>

[0038] The downward direction is the direction of gravity. That is, the downward direction is the direction pointed to by the perpendicular line of the suspended object.

[0039] <Up and down direction>

[0040] The up and down directions refer to the directions along the top and bottom, regardless of the orientation, as long as it is along the top and bottom directions.

[0041] <Length direction>

[0042] This refers to the direction in which a component or part with a long, narrow shape extends. It also refers to the direction in which the longest part or region extends.

[0043] <Width direction>

[0044] This refers to the direction in which a component or part with a long, narrow shape extends along its short side, such as a direction perpendicular to its length. It also refers to the direction in which the shortest part or region extends.

[0045] <<<<First Implementation Method>>>>

[0046] <<<Structure of Blood Purification Device 70>>>

[0047] Figure 1 This is a schematic diagram illustrating the structure of the drug supply device 10A according to the first embodiment. The drug supply device 10A of the first embodiment is connected to the blood purification device 70 and is suitable for hemodialysis devices.

[0048] The blood purification device 70 mainly comprises: a dialyzer 20 with blood purification function; a blood circuit connected to an arterial blood circuit 30 and a venous blood circuit 40; a blood pump 50; a dialysis device body 60 connected to a dialysate inlet line 62 and a dialysate outlet line 64; a control device 66; a drug-liquid clamping mechanism 120; a dialysis pump 130; a liquid level regulating pump 140; a liquid level detection device 150; and an empty / liquid detection device 160.

[0049] <Dialyzer 20>

[0050] The dialyzer 20 has a blood purification membrane (not shown). The blood purification membrane can be a hollow fiber hemodialysis membrane, a hemodialysis filtration 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 the opening for introducing blood into the dialyzer 20. The blood outlet 24 is the opening for removing the blood introduced into the dialyzer 20. Furthermore, the dialyzer 20 also has a dialysate inlet 26 and a dialysate outlet 28. The dialysate inlet 26 is the opening for introducing dialysate into the dialyzer 20. The dialysate outlet 28 is the opening for discharging the dialysate introduced into the dialyzer 20. The dialyzer 20 purifies the blood by bringing the blood introduced through the blood inlet 22 into contact with the dialysate via the blood purification membrane.

[0051] <Arterial Side Blood Circuit 30>

[0052] The arterial side blood circuit 30 is mainly composed of a flexible, elongated tubing. The arterial side blood circuit 30 has a first end 32 and a second end 34. The first end 32 of the arterial side blood circuit 30 is connected to the blood inlet 22 of the dialyzer 20. Blood collected from the patient's blood vessels is introduced from the first end 32 of the arterial side blood circuit 30, through the blood inlet 22 of the dialyzer 20, into the blood purification membrane of the dialyzer 20. The second end 34 of the arterial side blood circuit 30 may be provided with a connector (not shown) for mounting an arterial side puncture needle (not shown).

[0053] <Venous blood circuit 40>

[0054] The venous blood circuit 40 is identical to the arterial blood circuit 30, primarily consisting of a flexible, elongated tubing. The venous blood circuit 40 has a first end 42 and a second end 44, and an air trapping chamber (not shown) is located midway through the tubing. 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 exited from the blood outlet 24 of the dialyzer 20. The second end 44 of the venous blood circuit 40 may be fitted with a connector (not shown) for mounting a venous puncture needle (not shown).

[0055] <Blood Pump 50>

[0056] A blood pump 50 is disposed between the first end 32 and the second end 34 of the arterial side blood circuit 30. The blood pump 50 is composed of a tubing pump. The tubing pump has a rotatable roller (not shown). The rotating roller flattens the tubing, thereby causing blood and pre-filling fluid to flow within the tubing of the arterial side blood circuit 30.

[0057] <Extracorporeal circulation>

[0058] Blood collected from the patient via the arterial side puncture needle travels through the arterial side blood circuit 30 to the dialyzer 20, where it is purified. After purification, the blood flows through the venous side blood circuit 40 and is returned to the patient via the venous side puncture needle. This achieves extracorporeal circulation.

[0059] <Arterial side and venous side>

[0060] The side of the puncture needle that draws blood is called the arterial side, and the side that draws back blood is called the venous side. Therefore, whether it is called the arterial side or the venous side is not determined by whether the blood vessel being punctured is an artery or a vein.

[0061] <Artery clamping mechanism 36 and vein clamping mechanism 46>

[0062] The arterial side blood circuit 30 is provided with an arterial clamping mechanism 36 at its front end, which can open and close the flow path of the arterial side blood circuit 30. The venous side blood circuit 40 is provided with a venous clamping mechanism 46 at its front end, which can open and close the flow path of the venous side blood circuit 40. The arterial clamping mechanism 36 and the venous clamping mechanism 46 are controlled to be in an open or closed state by a control signal output from the control device 66.

[0063] <Dialysis fluid inlet tubing 62 and dialysis fluid outlet tubing 64>

[0064] The dialysate inlet 26 of the dialyzer 20 is connected to a dialysate inlet line 62. The dialysate outlet 28 of the dialyzer 20 is connected to a dialysate outlet line 64. The dialysate is introduced into the dialyzer 20 via the dialysate inlet line 62, passes through the outside of the hollow fiber membrane, and is then discharged through the dialysate outlet line 64. The inner side of the hollow fiber membrane (purification membrane) of the dialyzer 20 forms a blood flow path for blood flow, while the outer side of the hollow fiber membrane forms a dialysate flow path for dialysate flow.

[0065] <Dialysis device main body 60>

[0066] The main body 60 of the dialysis apparatus extends with a dialysate inlet line 62 and a dialysate outlet line 64. The main body 60 of the dialysis apparatus includes a dialysate delivery pump and a dialysate removal pump (neither shown). The dialysate delivery pump introduces dialysate prepared to a predetermined concentration into the dialyzer 20, and simultaneously discharges the dialysate after dialysis from the dialyzer 20. The dialysate removal pump removes water from the blood flowing in the dialyzer 20.

[0067] <Control Device 66>

[0068] Figure 10 This is a functional block diagram illustrating the overall function of the dialysis apparatus main body 60, which includes the control device 66. The dialysis apparatus main body 60 includes an input section, a control device 66, and an output section.

[0069] The input section includes devices and components such as a touch panel and keyboard that can be operated by the operator of the main body 60 of the dialysis device. The operator can input data and control commands through the input section. After detecting the operator's input operation, the input section outputs a detection signal corresponding to the input operation to the control device 66.

[0070] The control device 66 mainly includes a processor (CPU (Central Processing Unit), etc.), ROM (Read-Only Memory), RAM (Random Access Memory), I / O (Input / Output Interface), I / F (Interface Device), and auxiliary storage devices (HOD (Hard Disk Drive), SSD (Solid State Drive), etc.). The ROM stores programs and constants used to perform various processes such as control processing. The RAM temporarily stores the values ​​of variables used during program execution.

[0071] The output unit mainly includes a blood pump 50, a liquid level regulating pump 140, a drug clamping mechanism 120, an artery clamping mechanism 36, and a solenoid valve 370 (described in detail in the third embodiment below). The operator operates the input unit, which outputs a detection signal corresponding to the input operation to the control device 66. The control device 66 then outputs a control signal to the output unit, thereby controlling the output unit.

[0072] The control device 66 outputs various control signals and inputs various detection signals via I / O. For example, the control device 66 outputs control signals to the liquid clamping mechanism 120, the diaphragm pump 130, the liquid level regulating pump 140, etc. (described later). Furthermore, detection signals are input to the control device 66 from the liquid level detection device 150, the air / liquid detection device 160, etc.

[0073] <<Drug Clamping Mechanism 120>>

[0074] A liquid holding mechanism 120 is installed on the liquid supply line 100 (described later) of the liquid supply device 10A. The liquid holding mechanism 120 can be in either an open or closed state. When the liquid holding mechanism 120 is in the open state, liquid can flow in the liquid supply line 100. When the liquid holding mechanism 120 is in the closed state, liquid cannot flow in the liquid supply line 100.

[0075] The liquid medicine clamping mechanism 120 has a driving device such as an electromagnet and a motor (not shown). The liquid medicine clamping mechanism 120 is driven by a control signal output from the control device 66, thereby changing to an open or closed state.

[0076] <<Diaphragm Pump 130>>

[0077] The diaphragm pump 130 has a deformable diaphragm 131. The diaphragm pump 130 controls the flow of liquid by deforming the diaphragm 131. The diaphragm 131 of the diaphragm pump 130 is driven by a leveling pump 140. The diaphragm pump 130 presses or draws in the diaphragm 131 through the leveling pump 140. By pressing or drawing in the diaphragm 131, the diaphragm 131 deforms, 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 and the venous blood circuit 40. The diaphragm pump 130 can repeatedly press and draw in the diaphragm 130 through the leveling pump 140.

[0078] In the first embodiment, a diaphragm pump 130 is simultaneously installed on both the arterial side blood circuit 30 and the venous side blood circuit 40. In the first embodiment, the diaphragm pump 130 installed on the arterial side blood circuit 30 is mainly used, and the diaphragm pump 130 allows fluid to flow within the arterial side blood circuit 30.

[0079] <<Liquid Level Adjustment Pump 140>>

[0080] The liquid level regulating pump 140 deforms the diaphragm 131 of the diaphragm pump 130. The liquid level regulating pump 140 presses or draws in the diaphragm 131 of the diaphragm pump 130.

[0081] The liquid level regulating pump 140 has a drive device (not shown) such as a solenoid valve and a motor. The liquid level regulating pump 140 drives the drive device by a control signal output from the control device 66, thereby performing pressing or suction.

[0082] <<Liquid Level Detection Device 150>>

[0083] The liquid level detection device 150 can detect the amount of undiluted heparin and diluted heparin introduced into the pipette 110. The liquid level detection device 150 outputs a signal to the control device 66 to display the liquid level.

[0084] <<Air and Liquid Detection Device 160>>

[0085] The empty liquid detection device 160 can detect the presence of undiluted heparin or diluted heparin in the pipette 110. The empty liquid detection device 160 outputs a signal indicating the absence of heparin or diluted heparin. By providing the empty liquid detection device 160, diluted heparin can be dispensed until the pipette 110 becomes empty during the drug preparation process described later, thus reducing waste caused by drug residue. Furthermore, the dispensing of diluted heparin can be stopped at the point when the pipette 110 becomes empty, thereby reducing the risk of air entering the arterial blood circuit 30.

[0086] <<<Pharmaceuticals, etc.>>>

[0087] Heparin (Anticoagulant)

[0088] In dialysis treatment, heparin is used as a blood anticoagulant. It is usually delivered in the form of a syringe or similar container.

[0089] <Prefill solution (diluent)>

[0090] In dialysis treatment, normal saline, dialysate, etc., are used as pre-filling solutions. Heparin is diluted with the pre-filling solutions during dialysis treatment.

[0091] <<<Structure of the Liquid Supply Device 10A>>>

[0092] The drug supply device 10A can be installed outside the blood circuit, allowing it to be put into use with minimal modifications to the existing blood circuit.

[0093] like Figure 1 As shown, the liquid medicine supply device 10A mainly includes a liquid medicine pipeline 100 and a pipette 110.

[0094] <<Medication Piping 100>>

[0095] The drug delivery line 100 is connected to the blood circuit. Liquid can flow between the drug delivery line 100 and the blood circuit. The liquid can be a pre-filled solution, diluted heparin, etc., but is not limited to these. For example, the drug delivery line 100 is connected and communicates with the arterial side blood circuit 30. The drug delivery line 100 is preferably constructed of a flexible tubing or the like. The pipette 110 can be positioned away from the arterial side blood circuit 30.

[0096] The medication tubing 100 is connected to the arterial side blood circuit 30 at the connector 180. Preferably, the medication tubing 100 is detachably connected at the connector 180. The medication tubing 100 can be used as a disposable consumable.

[0097] <<Pipette 110>>

[0098] Heparin and prefilled solution are introduced into pipette 110. The heparin is diluted with the prefilled solution within pipette 110. A pipette is an instrument used to collect, temporarily store, and transfer small amounts of liquid. Pipettes may have measuring graduations. Using measuring graduations allows for easy and convenient volume measurement. Pipettes can be used as disposable consumables. Furthermore, any container capable of temporarily collecting heparin and prefilled solution, and capable of dispensing undiluted heparin or diluted heparin, is acceptable.

[0099] The pipette 110 is generally elongated and arranged vertically along its length. The pipette 110 is designed to be flipped up and down. The pipette 110 can be in either an upright or inverted position. The upright position is when the upper opening 114 (described in detail later) of the pipette 110 faces upwards, which is the preparation position for drug administration (see [reference]). Figure 4 ), dilution process (refer to) Figure 3 The state of pipette 110 in the middle. The inverted state is when the upper opening 114 of pipette 110 faces downwards, which is the state during the filling process (refer to...). Figure 2 The state of pipette 110 in the middle.

[0100] The vertical rotation of pipette 110 can be performed manually or by a drive device such as a motor (not shown). The control device 66 of the blood purification device 70 outputs a control signal to the drive device such as a motor to rotate pipette 110 vertically. When the control device 66 of the blood purification device 70 outputs an upright command signal, the pipette 110 switches to an upright position via the drive device such as a motor. The control device 66 can determine that the pipette 110 is in an upright position by outputting the upright command signal. When the control device 66 of the blood purification device 70 outputs an inverted command signal, the pipette 110 switches to an inverted position via the drive device such as a motor. The control device 66 can determine that the pipette 110 is in an inverted position by outputting an inverted command signal.

[0101] Alternatively, a sensor (not shown) can be installed to detect whether the pipette 110 is upright or inverted. This sensor, whether optical, mechanical, or using other detection methods, only needs to be able to detect the upright or inverted state of the pipette 110 and output a signal displaying 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 from the sensor that displays the detection result. Even in the event of a malfunction in the drive device such as the motor, the state of the pipette 110 can be accurately obtained.

[0102] Furthermore, when the operator manually flips the pipette 110 upside down, the operator operates the touch panel after completing the flipping operation. For example, when the operator places the pipette 110 in an upright position, the operator inputs information indicating that it is in an upright position on the touch panel. Through this operation, the touch panel outputs a signal to the control device indicating that it is in an upright position. Thus, the control device 66 can determine that the pipette 110 is in an upright position. Conversely, when the operator places the pipette 110 in an inverted position, the operator outputs information indicating that it is in an inverted position on the touch panel. Through this operation, the touch panel outputs a signal to the control device indicating that it is in an inverted position. Thus, the control device 66 can determine that the pipette 110 is in an inverted position.

[0103] The pipette 110 mainly includes a receiving part 112, an extension part 113, an upper opening part 114, and a lower opening part 116.

[0104] <Storage Section 112>

[0105] The receiving section 112 has a long, generally cylindrical shape. Heparin and prefilling solution are introduced into the receiving section 112. When prefilling solution is introduced into the receiving section 112, the heparin is diluted by the prefilling solution within the receiving section 112. Conversely, when no prefilling solution is introduced into the receiving section 112, the heparin is not diluted by the prefilling solution within the receiving section 112; it is simply in a state of being contained within the heparin.

[0106] <Extension 113>

[0107] The extension 113 has a long, generally cylindrical shape. The extension 113 extends from the upper part of the receiving portion 112 in a direction away from the receiving portion 112. The extension 113 has a smaller diameter than the receiving portion 112. By making the extension 113 smaller than the receiving portion 112, it is easy to insert or remove the extension 113 from the openings of various containers, adapting it to containers of different shapes and sizes, thereby enabling the heparin to be received into the pipette 110. It is particularly preferable that the extension 113 is configured to gradually narrow (tapered) away from the receiving portion 112, facilitating easy insertion or removal of the extension 113 from the openings of various containers.

[0108] The extension portion 113 and the storage portion 112 are arranged concentrically. That is, the extension portion 113 is arranged such that the central axis of the extension portion 113 is aligned with the central axis of the storage portion 112.

[0109] <Upper opening 114>

[0110] The upper end of the extension 113 (the portion furthest from the receiving section 112) has an upper opening 114. The upper opening 114 communicates with both the receiving section 112 and the extension 113. The upper opening 114 can be connected to a medicine bottle (see reference). Figure 2 The heparin stored in the medicine bottle is introduced into the storage section 112 through the extension section 113 from the upper opening 114.

[0111] In its normal upright position without tilting, the upper opening 114 of the transfer tube 110 faces upward. On the other hand, in its inverted position with the transfer tube 110 tilted, the upper opening 114 faces downward. Furthermore, when the transfer tube 110 is placed in its inverted position with the upper opening 114 facing downward, heparin is introduced into the receiving section 112 through the upper opening 114.

[0112] <Lower end opening 116>

[0113] The pipette 110 has a lower opening 116 at its lower part. The lower opening 116 communicates with the receiving part 112. The pipette 110 is connected to the drug supply line 100 through the lower opening 116. The prefilled solution is introduced into the receiving part 112 through the drug supply line 100 from the lower opening 116. Furthermore, heparin diluted with the prefilled solution is discharged from the receiving part 112 through the lower opening 116 into the drug supply line 100. In the normal upright position without inverting the pipette 110, the lower opening 116 faces downwards. Both the prefilled solution and the diluted heparin are introduced or discharged in the normal upright position without inverting the pipette 110, i.e., with the lower opening 116 facing downwards. Similarly, heparin undiluted with the prefilled solution is discharged in the normal upright position without inverting the pipette 110, i.e., with the lower opening 116 facing downwards.

[0114] <<Other Components of the Liquid Supply Device 10A>>

[0115] In the above examples, the drug supply device 10A mainly includes: a drug supply line 100; and a pipette 110. Furthermore, the blood purification device 70 mainly includes: a dialyzer 20 with hemodialysis function; a blood circuit connecting an arterial blood circuit 30 and a venous blood circuit 40; a blood pump 50; a dialysis device body 60 connecting a dialysate inlet line 62 and a dialysate outlet line 64; a control device 66; a drug clamping mechanism 120; a dialysis pump 130; a liquid level regulating pump 140; a liquid level detection device 150; and an empty / liquid detection device 160.

[0116] The structure is not limited to this. The drug supply device 10A may also include at least one of the following: a drug clamping mechanism 120, a diaphragm pump 130, a liquid level regulating pump 140, a liquid level detection device 150, and an empty / liquid detection device 160. For example, a control device (not shown) with a processor (processing device) may be provided on the drug supply device 10A, allowing control signals to be output from the control device or detection signals to be input to the control device. Furthermore, the control device of the drug supply device 10A may be connected to the control device 66 of the blood purification device 70 so that they can communicate with each other. The portions of the drug clamping mechanism 120, diaphragm pump 130, liquid level regulating pump 140, liquid level detection device 150, and empty / liquid detection device 160 controlled by the control device 66 of the blood purification device 70 and the portions controlled by the control device of the drug supply device 10A may be appropriately controlled separately.

[0117] Alternatively, the entirety of the liquid-holding mechanism 120, diaphragm pump 130, liquid level regulating pump 140, liquid level detection device 150, and empty / liquid detection device 160 can be controlled solely by the control device of the liquid-supply device 10A. The liquid-holding mechanism 120, diaphragm pump 130, and liquid level regulating pump 140 are controlled by control signals output from the control device of the liquid-supply device 10A; the detection signals output from the liquid level detection device 150 and empty / liquid detection device 160 are input to the control device of the liquid-supply device 10A.

[0118] <<Processing of the drug supply device 10A>>

[0119] Figure 2 This is a schematic diagram illustrating the filling process in the liquid medicine supply device 10A according to the first embodiment. Figure 3 This is a schematic diagram illustrating the dilution process in the liquid medicine supply device 10A according to the first embodiment. Figure 4 This is a schematic diagram illustrating the drug administration preparation process in the drug supply device 10A according to the first embodiment. Figures 2 to 4 As shown, the processing performed by the drug supply device 10A includes a filling process, a dilution process, and a drug administration preparation process.

[0120] exist Figures 2 to 4 In the diagram, valves indicated by white are in the open state, and valves indicated by black are in the closed state. Meanwhile, Figures 2 to 4 In the diagram, a diagonal line indicates the location of heparin, and a horizontal line indicates the location of the pre-fill solution. A white arrow pointing to the left on diaphragm pump 130 indicates that diaphragm 131 is being pressed; a white arrow pointing to the right on diaphragm pump 130 indicates that diaphragm 131 is being drawn.

[0121] <<Filling Process>>

[0122] like Figure 2As shown, the filling process involves introducing heparin from the medication bottle into the pipette 110. Through this filling process, heparin contained in a container such as a medication bottle (the container at the time of delivery) can be introduced into the pipette 110. Heparin can be used without being limited by the shape of the container at the time of delivery, the opening of the container, or other container features. It is compatible with various containers used to hold heparin. Furthermore, during the filling process, the blood pump 50 is stopped.

[0123] <Filling Process 1>

[0124] Figure 2 (a) indicates the initial step of the filling process. At this time, both the drug clamping mechanism 120 and the artery clamping mechanism 36 are in the open state (shown in white).

[0125] First, place the heparin vial under the pipette 110. Then, invert the pipette 110 so that the upper opening 114 is on the lower side (inverted state). The inversion of the pipette 110 can be done manually or controlled by a control signal from the control device 66. By equipping the pipette 110 with a drive device such as a motor, the inversion of the pipette 110 can be controlled by a control signal. Insert the upper opening 114, which is on the lower side, into the vial, making it connected to the vial.

[0126] <Filling Process 2>

[0127] Figure 2 (b) indicates the second step of the filling process.

[0128] The processor of control device 66 outputs a control signal to switch the liquid clamping mechanism 120 to the closed state (shown in black). The processor of control device 66 outputs a control signal to drive the liquid level regulating pump 140 to press the diaphragm 131 of the diaphragm pump 130.

[0129] <Filling Process 3>

[0130] Figure 2 (c) indicates the final step in the filling process.

[0131] The processor of control device 66 outputs a control signal to stop blood pump 50 and switch arterial clamping mechanism 36 to the closed state (black). The processor of control device 66 outputs a control signal to switch drug solution clamping mechanism 120 to the open state (white).

[0132] The processor of the control device 66 outputs a control signal to drive the liquid level adjustment pump 140 to draw water from the diaphragm 131 of the diaphragm pump 130, thereby creating a negative pressure inside the pipette 110. Because the inside of the pipette 110 is under negative pressure, the heparin stored in the medicine bottle is drawn out from the medicine bottle and introduced into the pipette 110.

[0133] The amount of heparin corresponding to the difference between the deformation of the diaphragm 131 of the diaphragm pump 130 due to pressing and the deformation due to suction is introduced into the pipette 110. By causing the diaphragm 131 of the diaphragm pump 130 to undergo at least one deformation action, the required amount of heparin can be introduced from the medicine bottle into the pipette 110.

[0134] pass Figure 2 (a) to Figure 2 The filling process shown in (c) is not limited by the shape of the container holding heparin, the opening, or other container form, and heparin is introduced into pipette 110.

[0135] After the filling process is completed, the transfer tube 110 is flipped upside down (from an inverted state to an upright state) so that the upper opening 114 is on the upper side. Similar to the filling process, the reversing action of the pipette 110 can be done manually or controlled by the control signal of the control device 66. Pre-positioning the pipette in the upright state allows for a smooth transition to the subsequent dilution and drug administration preparation processes.

[0136] <<Dilution Process>>

[0137] like Figure 3 As shown, the dilution step involves introducing a pre-filled solution into the pipette 110, thereby diluting the heparin introduced into the pipette 110 within the pipette 110. Alternatively, if heparin dilution is not required, the dilution step can be omitted, and the process can proceed directly to the subsequent drug administration preparation step.

[0138] <Dilution Process 1>

[0139] Figure 3 (a) indicates the initial step of the dilution process.

[0140] The processor of control device 66 outputs a control signal to switch the drug clamping mechanism 120 to the closed state (black). The processor of control device 66 drives blood pump 50 by outputting a control signal, causing the rotor (not shown) of blood pump 50 to rotate forward, introducing pre-filled fluid into the arterial side blood circuit 30. Forward rotation is the direction in which fluid flows from the arterial side blood circuit 30 to the venous side blood circuit 40. Reverse rotation is the direction in which fluid flows from the venous side blood circuit 40 to the arterial side blood circuit 30. For example, a pre-filled fluid storage bag containing pre-filled fluid is connected to the arterial side blood circuit 30 (not shown). Blood pump 50 guides the pre-filled fluid from the pre-filled fluid storage bag to the arterial side blood circuit 30, thereby allowing the pre-filled fluid to be discharged into the arterial side blood circuit 30. After the required amount of pre-filled fluid has been discharged into the arterial side blood circuit 30, blood pump 50 is stopped.

[0141] <Dilution Process 2>

[0142] Figure 3(b) indicates the second step in the dilution process.

[0143] The processor of control device 66 outputs a control signal, and the liquid clamping mechanism 120 remains closed (black). The processor of control device 66 outputs a control signal to drive the liquid level regulating pump 140 to draw suction from the diaphragm 131 of the diaphragm pump 130. Furthermore, in dilution step 2, the blood pump 50 is in a stopped state.

[0144] <Dilution process 3>

[0145] Figure 3 (c) indicates the final step in the dilution process.

[0146] When the blood pump 50 is running, the processor of the control device 66 outputs a control signal to stop the blood pump 50 and switch the arterial clamping mechanism 36 to the closed state. The processor of the control device 66 outputs a control signal to switch the drug clamping mechanism 120 to the open state (white).

[0147] The processor of the control device 66 outputs a control signal to drive the liquid level regulating pump 140, which presses the diaphragm 131 of the diaphragm pump 130. This creates a positive pressure state within the arterial blood circuit 30. Because the arterial blood circuit 30 is now under positive pressure, the pre-filled fluid introduced into the arterial blood circuit 30 is forced out through the pipette 110 and introduced into the pipette 110 via the drug delivery line 100.

[0148] A pre-filled fluid corresponding to the difference between the deformation of the diaphragm 131 of the diaphragm pump 130 due to pressing and the deformation due to suction is introduced into the pipette 110. By causing the diaphragm 131 of the diaphragm pump 130 to complete at least one reciprocating motion, the required amount of pre-filled fluid can be introduced from the arterial side blood circuit 30 into the pipette 110.

[0149] In this way, the heparin contained in pipette 110 can be diluted with prefilled solution within pipette 110. The heparin diluted with prefilled solution will be referred to as diluted heparin below.

[0150] The liquid level detection device 150 is used to detect the amount of diluted heparin stored in the pipette 110 and sends a detection signal indicating the amount of diluted heparin to the processor of the control device 66. The processor of the control device 66 can determine whether the required amount of diluted heparin has been stored in the pipette 110. The processor of the control device 66 can calculate the concentration of diluted heparin.

[0151] <<Preparation Procedures for Drug Administration>>

[0152] like Figure 4As shown, the drug administration preparation step involves placing undiluted heparin or diluted heparin into the pipette 110, which is then ready to be administered to the patient. Furthermore, the blood pump 50 is stopped during the drug administration preparation step. If heparin is to be diluted, the process transitions from the dilution step to the drug administration preparation step; otherwise, it transitions directly from the filling step to the drug administration preparation step.

[0153] <Preparation Procedure for Drug Administration 1>

[0154] Figure 4 (a) indicates the initial step in the drug administration preparation process.

[0155] The processor of control device 66 outputs a control signal to switch the liquid clamping mechanism 120 to the closed state (black). The processor of control device 66 outputs a control signal to drive the liquid level regulating pump 140 to press the diaphragm 131 of the diaphragm pump 130.

[0156] <Preparation Procedure for Drug Administration 2>

[0157] Figure 4 (b) indicates the final step in the drug administration preparation process.

[0158] When the blood pump is running, the processor of the control device 66 outputs a control signal to stop the blood pump and switch the arterial clamping mechanism 36 to the closed state (black). The processor of the control device 66 outputs a control signal to switch the drug clamping mechanism 120 to the open state (white). The processor of the control device 66 outputs a control signal to drive the liquid level adjusting pump 140 to draw suction from the diaphragm 131 of the diaphragm pump 130. This creates a negative pressure state inside the pipette 110 and the arterial blood circuit 30. By creating a negative pressure state inside the pipette 110 and the arterial blood circuit 30, the diluted heparin contained in the pipette 110 is drawn out from the pipette 110 and introduced into the arterial blood circuit 30 through the drug line 100.

[0159] The amount of diluted heparin corresponding to the difference between the deformation of the diaphragm 131 due to pressing and the deformation due to suction of the diaphragm pump 130 flows through the drug solution line 100 and is delivered to the arterial side blood circuit 30. By causing the diaphragm 131 of the diaphragm pump 130 to complete at least one action, the required amount of diluted heparin can be delivered to the arterial side blood circuit 30.

[0160] Thus, through the aforementioned filling, dilution, and administration preparation steps, heparin can be diluted with pre-filled solution in pipette 110 to administer the required amount of diluted heparin to the patient. Furthermore, without using pre-filled solution to dilute heparin, the aforementioned filling and administration preparation steps allow the patient to be administered the required amount of undiluted heparin.

[0161] <<First Embodiment's Drug Supply Device 10A, Filling Process, Dilution Process, and Drug Administration Preparation Process>>

[0162] According to the drug supply device 10A of the first embodiment, the diaphragm pump 130 and the liquid level adjustment pump 140 installed on the blood circuit can be used to introduce heparin into the pipette 110, introduce pre-filled solution into the pipette 110, or export diluted heparin to the arterial side blood circuit 30. The diaphragm pump 130 and the liquid level adjustment pump 140 can be effectively utilized in the filling process, the dilution process, and the drug administration preparation process.

[0163] Since the dialysis pump 130 and the liquid level regulating pump 140 can be controlled by the control device 66 of the dialysis apparatus body 60, the heparin dilution and drug preparation operations can be automated, improving the reproducibility of the prefill solution dilution concentration and ensuring stable operation. Furthermore, automation simplifies operations and reduces the burden on the user. Moreover, the filling, dilution, and drug preparation processes can be performed continuously, or the filling and drug preparation processes can be performed consecutively.

[0164] Furthermore, the pipette 110 has an extension 113 that is thinner than the receiving portion 112. Therefore, the extension can be easily inserted into or removed from the opening of a container such as a vial containing heparin. This makes it less susceptible to the influence of the shape or size of the container or opening on the heparin delivery to the pipette 110. The user can then use the required amount of heparin. The heparin stored in the container can be used in multiple treatments. Since heparin administration does not require a syringe, treatment costs are reduced.

[0165] The pipette 110 can be used not only for the introduction and storage of heparin, but also for the introduction and storage of prefill solution and the dilution of heparin, thereby making efficient use of the pipette 110 and reducing the number of parts. Furthermore, by introducing prefill solution into the pipette 110, the heparin in the pipette 110 can be diluted simultaneously, thereby simplifying the dilution process.

[0166] By employing a flexible drug delivery system 100, pipettes 110 and the like can be positioned away from the blood circuit. This increases the flexibility in the placement of pipettes 110 and the like. Pipettes 110 and the like can be configured to avoid interference with other devices, thereby improving user operability.

[0167] The drug delivery line 100 is suitable for both of the following processes: the dilution process of introducing pre-filled solution from the arterial side blood circuit 30 into the pipette 110; and the drug administration preparation process of exporting diluted heparin from the pipette 110 to the arterial side blood circuit 30. Therefore, the number of parts can be reduced and the structure can be simplified.

[0168] <<<<Second Implementation Method>>>>

[0169] Figure 5This is a schematic diagram illustrating the filling process in the drug supply device 10B according to the second embodiment. In the second embodiment, the drug supply device 10B is also connected to the blood purification device 70 and is suitable for a hemodialysis device. Furthermore, in the second embodiment, the blood purification device 70 has the same structure as the first embodiment, except that it does not include the diaphragm pump 130 and the liquid level regulating pump 140. In the second embodiment, the same reference numerals are used to denote the structures that are the same as those in the first embodiment. Figure 5 The main body 60 of the dialysis device and the control device 66 are omitted from the illustration.

[0170] <<<Structure of Blood Purification Device 70>>>

[0171] The blood purification device 70 of the second embodiment mainly includes: a dialyzer 20 with blood purification function; a blood circuit connected to an arterial blood circuit 30 and a venous blood circuit 40; a blood pump 50; a dialysis device body 60 (not shown) connected to a dialysate inlet line 62 and a dialysate outlet line 64; a control device 66 (not shown); a drug clamping mechanism 120; a liquid level detection device 150; and a drip sensor 220.

[0172] The blood purification device 70 of the second embodiment has a drip sensor 220 but does not have a diaphragm pump 130 and a liquid level regulating pump 140, which is different from the blood purification device 70 of the first embodiment.

[0173] <<<Structure of the Liquid Supply Device 10B>>>

[0174] The drug supply device 10B can be installed outside the blood circuit, allowing it to be put into use with minimal modifications to the existing blood circuit.

[0175] like Figure 5 As shown, the liquid medicine supply device 10B mainly includes: a liquid medicine pipeline 200; a pipette 110; and a dripping chamber 210.

[0176] The pipette 110 has the same structure and performs the same function as in the first embodiment.

[0177] <<Medication Piping 200>>

[0178] The drug delivery line 200 is connected to the blood circuit. Liquid can flow between the drug delivery line 100 and the blood circuit. The liquid can be a pre-filled solution, diluted heparin, etc., but is not limited to these. For example, the drug delivery line 200 is connected and communicates with the arterial side blood circuit 30. The drug delivery line 200 is preferably constructed of a flexible tubing or the like. The pipette 110 can be positioned away from the arterial side blood circuit 30.

[0179] The medication tubing 200 is connected to the arterial side blood circuit 30 at the connector 280. Preferably, the medication tubing 200 is detachably connected at the connector 280. The medication tubing 200 is the same as the medication tubing 100 and can be used as a disposable consumable.

[0180] <Drip chamber 210>

[0181] The drip chamber 210 separates the continuously flowing liquid into individual droplets, which then drip down under gravity. The drip chamber 210 is the component used for so-called infusion. Specifically, the drip chamber 210 can form undiluted heparin and diluted heparin into droplets and drip them down, as detailed below.

[0182] <Drop Sensor 220>

[0183] The drop sensor 220 detects the number of droplets falling in the drip chamber 210 (hereinafter referred to as the drop count) and outputs a detection signal displaying the drop count to the dialysis apparatus. The control device 66 of the dialysis apparatus body 60 can perform drop count-based processing. Furthermore, the control device 66 of the dialysis apparatus body 60 has the same structure and performs the same function as in the first embodiment. The control device 66 outputs control signals for controlling various control devices, and detection signals indicating the results detected by various detection devices are input to the control device 66.

[0184] Furthermore, in the second embodiment, the drop sensor 220 is detachably mounted on the dripping chamber 210, but is not limited to this structure. The drop sensor 220 can also be an integrated structure with the dripping chamber 210. The drop sensor 220 only needs to be able to detect the number of drops in the dripping chamber 210 and output a detection signal.

[0185] <<Other Structures of the Liquid Supply Device 10B>>

[0186] In the above examples, the blood purification device 70 of the second embodiment mainly includes: a dialyzer 20 with blood purification function; a blood line connected to an arterial blood circuit 30 and a venous blood circuit 40; a blood pump 50; a dialysis device body 60 connected to a dialysate inlet line 62 and a dialysate outlet line 64; a control device 66; a drug clamping mechanism 120; a liquid level detection device 150; and a drip sensor 220.

[0187] The liquid medicine supply device 10B mainly includes: a liquid medicine pipeline 200; a pipette 110; and a dripping chamber 210.

[0188] The present invention is not limited to this structure; the drug supply device 10B may also include at least one of the following: a drug clamping mechanism 120, a liquid level detection device 150, and a drip sensor. For example, a control device (not shown) with a processor (processing device) may be provided on the drug supply device 10B, allowing control signals to be output from the control device or detection signals to be input to the control device. Furthermore, the control device of the drug supply device 10B may be connected to the control device 66 of the blood purification device 70 so that they can communicate with each other. The portions of the drug clamping mechanism 120, the liquid level detection device 150, and the drip sensor 220 controlled by the control device 66 of the blood purification device 70 and the portions controlled by the control device of the drug supply device 10B may be appropriately controlled separately.

[0189] Alternatively, the entirety of the liquid holding mechanism 120, the liquid level detection device 150, and the drip sensor 220 can be controlled solely by the control device of the liquid supply device 10B. The liquid holding mechanism 120 is controlled by the control signal output from the control device of the liquid supply 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 liquid supply device 10B.

[0190] <<Processing of the Liquid Supply Device 10B>>

[0191] When using pre-filled solution to dilute heparin, the processing of the drug supply device 10B includes: a filling process, a dilution process, and a drug administration preparation process. When not using pre-filled solution to dilute heparin, the processing of the drug supply device 10B includes: a filling process and a drug administration preparation process. Furthermore, Figure 5 This indicates the dilution process (a) and the drug administration preparation process (b).

[0192] exist Figure 5 In the diagram, valves indicated by white are in the open state, and valves indicated by black are in the closed state. Furthermore, in... Figure 5 In the diagram, the location of heparin is indicated by a diagonal line, and the location of the prefill fluid is indicated by a horizontal line.

[0193] <<Filling Process>>

[0194] In the second embodiment, unlike the first embodiment, heparin is introduced into pipette 110 (see reference) by an operator (manually). Figure 2 ).

[0195] <<Dilution Process>>

[0196] like Figure 5As shown in (a), the dilution step involves introducing a pre-filled solution into the pipette 110, thereby diluting the heparin introduced into the pipette 110 within the pipette 110. Alternatively, if heparin dilution is not required, the dilution step can be omitted, and the process can proceed directly to the subsequent drug administration preparation step.

[0197] In the second embodiment, unlike the first embodiment, the pre-filling fluid is introduced into the pipette 110 from the arterial side blood circuit 30 by reversing the blood pump 50. The blood pump 50 can be reversed by a control signal from the control device 66. The liquid level detection device 150 can determine whether the pre-filling fluid in the pipette 110 has reached the required amount.

[0198] The drip chamber 210 is configured to be tilted up and down. The tilting of the drip chamber 210 can be done manually or controlled by a control signal from the control device 66. By equipping the drip chamber 210 with a drive device such as a motor (not shown), the pipette 110 can be tilted up and down by a control signal output from the control device 66.

[0199] The vertical rotation of the drip chamber 210 can be performed manually or by a drive device such as a motor (not shown). The control device 66 of the blood purification device 70 outputs a control signal to the drive device such as a motor to rotate the drip chamber 210 vertically. When the control device 66 of the blood purification device 70 outputs an upright command signal, the drip chamber 210 switches to an upright state via the drive device such as a motor. The control device 66 can determine that the drip chamber 210 is in an upright state by outputting the upright command signal. When the control device 66 of the blood purification device 70 outputs an inverted command signal, the drip chamber 210 switches to an inverted state via the drive device such as a motor. The control device 66 can determine that the drip chamber 210 is in an inverted state by outputting an inverted command signal.

[0200] In addition, a sensor (not shown) can be installed to detect whether the drip chamber 210 is upright or inverted. This sensor, whether optical, mechanical, or using other detection methods, is acceptable as long as it can detect the upright or inverted state of the drip chamber 210 and output a signal displaying the detection result. The control device 66 of the blood purification device 70 can obtain the state of the drip chamber 210 by receiving the signal from the sensor that displays the detection result. Even in the event of a malfunction in the drive device such as the motor, the state of the drip chamber 210 can be accurately obtained.

[0201] Furthermore, when the operator manually flips the drip chamber 210 upside down, the operator operates the touch panel after completing the flipping operation. For example, when the operator places the drip chamber 210 in an upright position, the operator inputs information indicating that it is in an upright position into the touch panel. Through this operation, the touch panel outputs a signal to the control device indicating that it is in an upright position. Thus, the control device 66 can determine that the state of the drip chamber 210 is upright. Conversely, when the operator places the drip chamber 210 in an inverted position, the operator inputs information indicating that it is in an inverted position into the touch panel. Through this operation, the touch panel outputs a signal to the control device indicating that it is in an inverted position. Thus, the control device 66 can determine that the state of the drip chamber 210 is in an inverted position.

[0202] Furthermore, the pipette 110 can be configured such that, regardless of whether the drip chamber 210 is in an upright or inverted state, the pipette 110 is always located above the drip chamber 210.

[0203] When the blood pump 50 is running, the processor of the control device 66 outputs a control signal to stop the blood pump 50 and switch the arterial clamping mechanism 36 to the closed state (black). The processor of the control device 66 outputs a control signal to switch the drug solution clamping mechanism 120 to the open state (white).

[0204] The processor of the control device 66 outputs a control signal to drive the blood pump 50. Driven by the blood pump 50, the pre-filled fluid introduced into the arterial side blood circuit 30 is forced out, flows through the drug solution line 200, passes through the drug solution clamping mechanism 120 and the drip chamber 210, and is introduced into the pipette 110. In this way, the pre-filled fluid can be introduced into the pipette 110.

[0205] An amount of prefill solution corresponding to the amount used to drive 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 prefill solution within the pipette 110. Similar to the first embodiment, in the second embodiment, the heparin diluted with the prefill solution is referred to as diluted heparin.

[0206] The liquid level detection device 150 is used to detect 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 required amount of undiluted heparin 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.

[0207] <<Preparation Procedures for Drug Administration>>

[0208] like Figure 5As shown in (b), the drug administration preparation process is the process of administering undiluted heparin or diluted heparin into the pipette 110 to the patient.

[0209] The drip chamber 210 is flipped up and down to return to its initial state. The flipping of the drip chamber 210 can be done manually or controlled by the control signal of the control device 66.

[0210] The processor of the control device 66 outputs a control signal to drive the blood pump 50. By causing the rotor (not shown) of the blood pump 50 to rotate forward, the diluted heparin corresponding to the amount driving the blood pump 50 flows through the drug solution line 200 and is delivered to the arterial side blood circuit 30.

[0211] Whenever undiluted heparin or diluted heparin drips into the drip chamber 210, the drip sensor 220 detects the droplet of heparin. The drip sensor 220 outputs a detection signal indicating the drip 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 thus calculates the total amount of undiluted heparin or diluted heparin administered. The control device 66 performs processing based on the total amount of undiluted heparin or diluted heparin. In addition, the volume of each drop of undiluted heparin or diluted heparin is predetermined and stored in the RAM or the like of the control device 66.

[0212] <<Based on the second embodiment of the drug supply device 10B, and the filling process, dilution process, and drug administration preparation process>>

[0213] According to the drug supply device 10B of the second embodiment, the blood pump 50 installed on the blood circuit can be used to introduce the pre-filled solution into the pipette 110 or to export diluted heparin to the arterial side blood circuit 30. The blood pump 50 can be effectively utilized in the dilution process and the drug administration preparation process.

[0214] According to the second embodiment of the drug supply device 10B, heparin can be diluted in the pipette 110 with a simple structure without using the diaphragm pump 130 and liquid level adjustment pump 140 of the first embodiment, and undiluted heparin and diluted heparin can be administered. The dilution process and drug administration preparation process can be performed without being limited by the blood circuit structure.

[0215] According to the drug supply device 10B of the second embodiment, the undiluted heparin and diluted heparin can be measured during the drug administration preparation process using the drip chamber 210 and the drip sensor 220. It can be constructed using components used in dialysis treatment sites, as long as it can be linked to the dialysis apparatus main body 60. That is, in the dialysis treatment site, the control device 66 of the blood purification device 70 receives the detection signal output from the drip sensor 220 and controls the blood pump 50 according to the number of drops. These devices, components, and parts can be effectively utilized to construct the drug supply device 10B of the second embodiment.

[0216] The pipette 110 can be used not only for the introduction and storage of heparin, but also for the introduction and storage of prefill solution and the dilution of heparin, thereby making efficient use of the pipette 100 and reducing the number of parts. In addition, by introducing prefill solution into the pipette 110, the heparin in the pipette 110 can be diluted simultaneously, thereby simplifying the dilution process.

[0217] By employing the flexible drug delivery system 200, the pipette 110 and other components can be positioned away from the blood circuit. This increases the flexibility in the placement of the pipette 110 and other components. The pipette 110 and other components can be configured to avoid interference with other devices, thereby improving user operability.

[0218] The drug delivery line 200 is suitable for both of the following processes: the dilution process of introducing pre-filled solution from the arterial side blood circuit 30 into the pipette 110; and the drug administration preparation process of discharging diluted heparin from the pipette 110 into the arterial side blood circuit 30. Therefore, the number of parts can be reduced and the structure can be simplified.

[0219] <<<<Third Implementation Method>>>>

[0220] Figure 6 This is a schematic diagram showing the structure of the drug supply device 10C according to the third embodiment. The drug supply device 10C of the third embodiment is the same as the drug supply device 10A of the first embodiment, and is connected to the blood purification device 70, suitable for hemodialysis devices. In the third embodiment, the same reference numerals are used to label the same structures as in the first embodiment.

[0221] In the third embodiment, the blood purification device 70 mainly includes: a dialyzer 20 with blood purification function; blood tubing connected to an arterial blood circuit 30 and a venous blood circuit 40; a blood pump 50; a dialysis device body 60 (not shown) connected to a dialysate inlet tubing 62 and a dialysate outlet tubing 64; a control device 66 (not shown); a diaphragm pump 330; a liquid level regulating pump 340; a solenoid valve 370; an extension 313; a liquid level detection device 150; and a drug clamping mechanism 320.

[0222] again, Figure 6 The dialysis apparatus body 60 and control device 66 are not shown in the illustration. Furthermore, the control device 66 of the dialysis apparatus body 60 has the same structure and performs the same function as in the first and second embodiments. The control device 66 outputs control signals for controlling various control devices, and simultaneously inputs detection signals indicating the results detected by various detection devices.

[0223] <Diaphragm Pump 330>

[0224] The diaphragm pump 330 has a deformable diaphragm 331, which controls the flow of liquid by deforming the diaphragm 331. The diaphragm 331 of the diaphragm pump 330 is driven by a liquid level regulating pump 340, which presses or draws the diaphragm 331. By pressing or drawing the diaphragm 331, negative pressure is generated 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 draw by the liquid level regulating pump 340.

[0225] Furthermore, since the diaphragm pump 330 does not come into contact with blood, it can be reused multiple times as a component of the blood purification device 70.

[0226] <Liquid Level Adjustment Pump 340>

[0227] The liquid level regulating pump 340 deforms the diaphragm 331 of the diaphragm pump 330. The liquid level regulating pump 340 presses or pumps the diaphragm 331 of the diaphragm pump 330.

[0228] The liquid level regulating pump 340 has a drive device (not shown) such as an electromagnet and a motor. The liquid level regulating pump 340 drives the drive device by a control signal output from the control device 66, thereby performing pressing or suction.

[0229] <Solenoid Valve 370>

[0230] Solenoid valve 370 is driven by an electromagnet (not shown). Control device 66 outputs a control signal to control the electromagnet. The control signal output from control device 66 controls the electromagnet, thereby putting solenoid valve 370 into an open or closed state. When solenoid valve 370 is in the open state (indicated in white), pipette 310 is connected to the outside, and corresponding to the driving of diaphragm pump 330, air in pipette 310 can be expelled to the outside. When solenoid valve 370 is in the closed state (indicated in black), pipette 310 is not connected to the outside, and even if diaphragm pump 330 is driven, air cannot flow between pipette 310 and the outside.

[0231] <Extension 313>

[0232] The extension 313 has a long, generally cylindrical shape. The extension 313 extends from the upper part of the receiving portion 312 in a direction away from the receiving portion 312. The extension 313 has a smaller diameter than the receiving portion 312. The extension 313 and the receiving portion 312 are arranged concentrically. That is, the extension 313 is configured such that its central axis coincides with the central axis of the receiving portion 312. The extension 313 communicates with the outside.

[0233] The diaphragm pump 330 and the solenoid valve 370 are connected to the extension 313. By controlling the diaphragm pump 330 and the solenoid valve 370, the air in the receiving part 312 can be vented to the outside, and then heparin and prefilling solution can be introduced into the pipette 310, as described later.

[0234] <<<Structure of the Liquid Supply Device 10C>>>

[0235] The drug supply device 10C can be installed outside the blood circuit, allowing it to be put into use with minimal modifications to the existing blood circuit.

[0236] like Figure 6 As shown, the liquid medicine supply device 10C mainly includes: a liquid medicine pipeline 300; and a pipette 310.

[0237] <<Medication Piping 300>>

[0238] The drug delivery line 300 is connected to the blood circuit, allowing liquid to flow between the drug delivery line 300 and the blood circuit. The liquid may be a pre-filled solution, diluted heparin, etc., but is not limited to these. For example, the drug delivery line 300 may be connected and communicate with the arterial side blood circuit 30. The drug delivery line 300 is preferably constructed of a flexible tubing, allowing the pipette 310 to be positioned away from the arterial side blood circuit 30.

[0239] The medication tubing 300 is connected to the arterial side blood circuit 30 at the connection 380. Preferably, the medication tubing 300 is connected in a detachable manner at the connection 380. Similar to the medication tubing 100 and 200, the medication tubing 300 can be used as a disposable consumable.

[0240] <<Pipette 310>>

[0241] Similar to the first and second embodiments, heparin and prefilling solution are introduced into pipette 310. In the third embodiment, heparin is also diluted with prefilling solution within pipette 310.

[0242] The pipette 310 is generally elongated. The pipette 310 is arranged vertically along its length. Unlike the first embodiment, this pipette 310 does not require vertical rotation.

[0243] The pipette 310 mainly has a receiving part 312, an upper opening part 314, a first lower opening part 316, and a second lower opening part 318.

[0244] <Storage Section 312>

[0245] The receiving section 312 has a long, roughly cylindrical shape. Heparin and prefilling solution are introduced into the receiving section 312. In the receiving section 312, the heparin is diluted by the prefilling solution. Furthermore, when no prefilling solution is introduced into the receiving section 312, the heparin is not diluted by the prefilling solution and is simply stored within the receiving section 312.

[0246] <Upper opening 314>

[0247] The pipette 310 has an upper opening 314 at its upper part, which is connected to an extension 313. The extension 313 communicates with the outside, and air is discharged from the receiving part 312 to the outside through the upper opening 314 and the extension 313.

[0248] <Extension 315>

[0249] The extension 315 has a long, generally cylindrical shape and extends from the lower part of the receiving part 312 in a direction away from (downwards) the receiving part 312. The extension 315 has a smaller diameter than the receiving part 312. By making the extension 315 smaller than the receiving part 312, it is easy to insert or remove the extension 315 from the opening of various containers. This allows heparin stored in containers of different shapes and sizes to be introduced into the receiving part 312. It is particularly preferable that the extension 315 is configured to gradually narrow (conical) away from the receiving part 312. This makes it easy to insert or remove the extension 315 from the opening of various containers.

[0250] <First lower end opening 316>

[0251] At the lower end of the extension 315 (the portion furthest from the receiving portion 312), there is a first lower opening 316. The first lower opening 316 communicates with the receiving portion 312 and the extension 315. The first lower opening 316 can be connected to a medicine bottle (see...). Figure 7 Heparin stored in the vial is introduced into the receiving section 312 through the extension 315 from the first lower opening 316.

[0252] <Second lower end opening 318>

[0253] The pipette 310 has a second lower opening 318 at its lower part. The second lower opening 318 communicates with the receiving part 312. The pipette 310 is connected to the drug supply line 300 through the second lower opening 318. The prefill solution is introduced into the receiving part 312 through the drug supply line 300 from the second lower opening 318. Furthermore, heparin diluted with the prefill solution is discharged from the receiving part 312 through the second lower opening 318 into the drug supply line 300. Also, if the heparin is not diluted with the prefill solution, the prefill solution is not introduced into the receiving part 312, and the undiluted heparin is discharged from the receiving part 312 through the second lower opening 318 into the drug supply line 300.

[0254] <Drug Clamping Mechanism 320>

[0255] A liquid clamping mechanism 320 is installed on the liquid pipeline 300. The liquid clamping mechanism 320 can be in either an open or closed state. When the liquid clamping mechanism 320 is in the open state, liquid can flow in the liquid pipeline 300. When the liquid clamping mechanism 320 is in the closed state, liquid cannot flow in the liquid pipeline 300.

[0256] The liquid medicine clamping mechanism 320 has a driving device such as an electromagnet and a motor (not shown). The liquid medicine clamping mechanism 320 is driven by a control signal output from the control device 66, thereby changing to an open or closed state.

[0257] <<Other Structures of the Liquid Supply Device 10C>>

[0258] In this third embodiment, the blood purification device 70 mainly includes: a dialyzer 20 with blood purification function; a blood circuit connected to an arterial blood circuit 30 and a venous blood circuit 40; a blood pump 50; a dialysis device body 60 connected to a dialysate inlet line 62 and a dialysate outlet line 64; a control device 66; a diaphragm pump 330; a liquid level regulating pump 340; a solenoid valve 370; an extension 313; and a liquid level detection device 150.

[0259] The liquid medicine supply device 10C mainly includes: a liquid medicine pipeline 300; and a pipette 310.

[0260] The structure is not limited to this. The medication supply device 10C may also include at least one of a diaphragm pump 330, a liquid level regulating pump 340, a solenoid valve 370, an extension 313, a liquid level detection device 150, and a medication clamping mechanism 320. For example, a control device (not shown) with a processor (processing device) can be provided on the medication supply device 10C, allowing control signals to be output from the control device or detection signals to be input to the control device. Furthermore, the control device of the medication supply device 10C can be connected to the control device 66 of the blood purification device 70 for mutual communication. The portions of the diaphragm pump 330, liquid level regulating pump 340, solenoid valve 370, and medication clamping mechanism 320 controlled by the control device 66 of the blood purification device 70 and those controlled by the control device of the medication supply device 10C can be appropriately controlled separately.

[0261] Alternatively, the entirety of the diaphragm pump 330, liquid level regulating pump 340, solenoid valve 370, and liquid clamping mechanism 320 can be controlled solely by the control device of the liquid supply device 10C. The diaphragm pump 330, liquid level regulating pump 340, solenoid valve 370, and liquid clamping mechanism 320 are controlled by control signals output from the control device of the liquid supply device 10C, and detection signals output from the liquid level detection device 150 are input to the control device of the liquid supply device 10C.

[0262] <<Processing of the drug supply device 10C>>

[0263] Figure 7 This is a schematic diagram illustrating the filling process of the liquid medicine supply device 10C according to the third embodiment. Figure 8 This is a schematic diagram illustrating the dilution process in the liquid supply device 10C according to the third embodiment. Figure 9 This is a schematic diagram illustrating the drug administration preparation process in the drug supply device 10C according to the third embodiment. Figures 7 to 9 As shown, when heparin is diluted with prefilled solution, the processing performed by the drug supply device 10C includes a filling step, a dilution step, and a drug administration preparation step. Furthermore, when heparin is not diluted with prefilled solution, the processing performed by the drug supply device 10C includes a filling step and a drug administration preparation step.

[0264] exist Figures 7 to 9 In the diagram, valves indicated by white are in the open state, and valves indicated by black are in the closed state. Furthermore, in... Figures 7 to 9 In the diagram, a diagonal line indicates the location of heparin, and a horizontal line indicates the location of the pre-fill solution. A white arrow pointing left on diaphragm pump 330 indicates that diaphragm 331 is being pressed; a white arrow pointing right on diaphragm pump 330 indicates that diaphragm 331 is being drawn.

[0265] <<Filling Process>>

[0266] like Figure 7 As shown, the filling process involves introducing heparin from the medication bottle into the pipette 310. Through this filling process, heparin contained in a medication bottle or other container (such as the container at the time of delivery) can be introduced into the pipette 310. Heparin can be used regardless of the shape of the container at the time of delivery, the opening of the container, or other container features. It is compatible with various containers used to hold heparin. Furthermore, during the filling process, the blood pump 50 is stopped.

[0267] <Filling Process 1>

[0268] Figure 7 (a) indicates the initial stage of the filling process. At this time, the drug solution clamping mechanism 320, the solenoid valve 370, and the arterial clamping mechanism 36 are all in the open state (white). Furthermore, in the drug solution supply device 10C, the arterial clamping mechanism 36 is in the open state (white) not only in the filling process but also in the dilution process and the drug administration preparation process. The drug solution supply device 10C may also omit the arterial clamping mechanism 36. When the drug solution supply device 10C does not have the arterial clamping mechanism 36, the control of the arterial clamping mechanism 36 can be omitted. Also, as... Figures 7-9 As shown, when the drug supply device 10C uses a system with an arterial clamping mechanism 36, it is sufficient to control the arterial clamping mechanism 36 to be normally open.

[0269] First, place a vial containing heparin below the pipette 310. Then, insert the first lower opening 316 of the pipette 310 into the vial, connecting it to the vial.

[0270] <Filling Process 2>

[0271] Figure 7 (b) indicates the second step of the filling process.

[0272] The processor of control device 66 outputs a control signal to switch the liquid clamping mechanism 320 to the closed state (black). The processor of control device 66 outputs a control signal to switch the solenoid valve 370 to the open state (white). The processor of control device 66 outputs a control signal to drive the liquid level regulating pump 140 to press the diaphragm 331 of the diaphragm pump 330.

[0273] <Filling Process 3>

[0274] Figure 7 (c) indicates the final step in the filling process.

[0275] The processor of control device 66 outputs a control signal to switch the liquid clamping mechanism 320 to the closed state (black). The processor of control device 66 also outputs a control signal to switch the solenoid valve 370 to the closed state (black). The processor of control device 66 then outputs a control signal to drive the liquid level adjusting pump 140 to draw suction from the diaphragm 331 of the diaphragm pump 330. This creates a negative pressure state inside the pipette 310. Because the inside of the pipette 310 is under negative pressure, the heparin contained in the medicine bottle is drawn out from the medicine bottle and introduced into the pipette 310.

[0276] The amount of heparin corresponding to the difference between the deformation of the diaphragm 331 of the diaphragm pump 330 due to pressing and the deformation due to suction is introduced into the pipette 310. By causing the diaphragm 331 of the diaphragm pump 330 to undergo at least one deformation action, the required amount of heparin can be introduced from the medicine bottle into the pipette 310.

[0277] pass Figure 7 (a) to Figure 7 The filling process shown in (c) is not limited by the shape of the container holding heparin, the opening, or other container shape, and heparin is introduced into the pipette 110.

[0278] <<Dilution Process>>

[0279] like Figure 8 As shown, the dilution step involves introducing pre-filled solution into pipette 310, thereby diluting the heparin introduced into pipette 310 within the pipette 310. Furthermore, during the dilution step, the blood pump 50 is stopped. If heparin dilution is not required, the dilution step can be omitted, and the process can proceed to the subsequent drug administration preparation step.

[0280] <Dilution Process 1>

[0281] Figure 8 (a) indicates the initial step of the dilution process.

[0282] The processor of control device 66 outputs a control signal to switch the drug clamping mechanism 320 to the closed state (black). The processor of control device 66, by outputting a control signal, causes the blood pump 50 to rotate forward, introducing pre-filled fluid into the arterial side blood circuit 30. For example, a pre-filled fluid storage bag containing pre-filled fluid is connected to the arterial side blood circuit 30 (not shown). The blood pump 50 guides the pre-filled fluid from the pre-filled fluid storage bag to the arterial side blood circuit 30, thereby introducing the pre-filled fluid into the arterial side blood circuit 30.

[0283] Remove pipette 310 from the vial and seal the first lower opening 316 of pipette 310 with clamp 319. By sealing, leakage of heparin introduced into pipette 310 from the first lower opening 316 can be prevented.

[0284] Alternatively, a drive device such as a motor can be configured on the pipette 310, and the pipette 310 can be pulled out of the medicine bottle by the control signal output from the control device 66, and the first lower opening 316 of the pipette 310 can be clamped.

[0285] <Dilution Process 2>

[0286] Figure 8 (b) indicates the second step in the dilution process.

[0287] The processor of control device 66 outputs a control signal to switch the liquid clamping mechanism 320 to the closed state (black). The processor of control device 66 outputs a control signal to switch the solenoid valve 370 to the open state (white). The processor of control device 66 outputs a control signal to drive the liquid level regulating pump 340 to press the diaphragm 331 of the diaphragm pump 330.

[0288] <Dilution process 3>

[0289] Figure 8 (c) indicates the final step in the dilution process.

[0290] The processor of control device 66 outputs a control signal to switch the drug clamping mechanism 320 to the open state (white). The processor of control device 66 outputs a control signal to switch the solenoid valve 370 to the closed state (black). The processor of control device 66 outputs a control signal to drive the liquid level regulating pump 340 to draw suction from the diaphragm 331 of the diaphragm pump 330. By creating a negative pressure inside the pipette 310, the pre-filled solution introduced into the arterial blood circuit 30 is drawn out and introduced into the pipette 310 via the drug line 300.

[0291] A prefill solution corresponding to the difference between the deformation of the diaphragm 331 of the diaphragm pump 330 due to pressing and the deformation due to suction is introduced into the pipette 310. By causing the diaphragm 331 of the diaphragm pump 330 to undergo at least one deformation action, the required amount of prefill solution can be introduced from the arterial side blood circuit 30 into the pipette 310. By introducing the prefill solution into the pipette 310, the heparin contained in the pipette 310 can be diluted with the prefill solution within the pipette 310.

[0292] In the third embodiment, the heparin diluted with the pre-filled solution is also referred to as diluted heparin. Similar to the first embodiment, by installing a liquid level detection device 150 on the pipette 310, the processor of the control device 66 can determine whether the required 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.

[0293] <<Preparation Procedures for Drug Administration>>

[0294] like Figure 9As shown, the drug administration preparation step involves dispensing undiluted heparin or diluted heparin into the pipette 310 to the patient. If heparin is diluted, the process transitions from the dilution step to the drug administration preparation step. If heparin does not need to be diluted, the process transitions directly from the filling step to the drug administration preparation step.

[0295] <Preparation Procedure for Drug Administration 1>

[0296] Figure 9 (a) indicates the initial step of the drug administration preparation process. Furthermore, in the drug administration preparation step 1, the blood pump 50 is in a stopped state.

[0297] The processor of control device 66 outputs a control signal to switch the liquid clamping mechanism 320 to the closed state (black). The processor of control device 66 outputs a control signal to switch the solenoid valve 370 to the open state (white). The processor of control device 66 outputs a control signal to drive the liquid level regulating pump 340 to draw suction from the diaphragm 331 of the diaphragm pump 330.

[0298] <Preparation Procedure for Drug Administration 2>

[0299] Figure 9 (b) indicates the final step in the drug administration preparation process.

[0300] When the blood pump is running, the processor of control device 66 outputs a control signal to stop the blood pump and switch the drug clamping mechanism 320 to the open state (white). The processor of control device 66 outputs a control signal to switch the solenoid valve 370 to the closed state (black). The processor of control device 66 outputs a control signal to drive the liquid level regulating pump 340 to press the diaphragm 331 of the diaphragm pump 330.

[0301] A corresponding amount of undiluted heparin or diluted heparin is introduced into the arterial blood circuit 30, corresponding to the deformation of the diaphragm 331 of the diaphragm pump 330. By causing the diaphragm 331 of the diaphragm pump 330 to complete at least one action, the required amount of undiluted heparin or diluted heparin can be introduced into the arterial blood circuit 300. This creates a positive pressure state inside the pipette 310. Due to the positive pressure state inside the pipette 310, the undiluted heparin or diluted heparin introduced into the pipette 310 is introduced into the arterial blood circuit 300 via the drug delivery line 300.

[0302] Thus, heparin can be diluted with prefilled solution in pipette 310 to administer undiluted or diluted heparin to the patient.

[0303] <<Third Embodiment: Drug Supply Device 10C, Filling Process, Dilution Process, and Drug Administration Preparation Process>>

[0304] According to the drug supply device 10C of the third embodiment, the diaphragm pump 330 and the liquid level regulating pump 340 can be used to introduce heparin into the pipette 310, introduce pre-filled solution into the pipette 310, or export diluted heparin to the arterial side blood circuit 30. The diaphragm pump 330 and the liquid level regulating pump 340 are arranged independently of the blood circuit. Therefore, the filling process, dilution process, and drug administration preparation process can be performed without being limited by the blood circuit structure.

[0305] Since the dialysis pump 330 and the liquid level regulating pump 340 can be controlled by the control device 66 of the dialysis apparatus body 60, the heparin dilution and drug administration operations can be automated, improving the reproducibility of the prefill solution dilution concentration and ensuring stable operation. Furthermore, automation simplifies operations and reduces the burden on the user. Moreover, the filling, dilution, and drug administration preparation processes can be performed continuously.

[0306] Furthermore, the pipette 310 is provided with an extension 315 extending away from the storage section 312. Therefore, the pipette 310 can be connected to the medicine bottle and heparin can be introduced into the storage section 312 without having to flip the pipette 310 up and down. In this way, since the pipette 310 does not need to be flipped up and down, the configuration can be simplified.

[0307] Furthermore, the pipette 310 has an extension 315 that is thinner than the receiving portion 312. Therefore, the extension 315 can be easily inserted into or removed from the opening of a container such as a vial containing heparin. This makes it less susceptible to the influence of the shape and size of the container or opening, allowing heparin to be introduced into the pipette 310. The user can then use the required amount of heparin. The heparin stored in the container can be used in multiple treatments. Since heparin administration does not require a syringe, treatment costs are reduced.

[0308] The pipette 310 can be used not only for the introduction and storage of heparin, but also for the introduction and storage of prefill solution and the dilution of heparin, thereby making efficient use of the pipette 310 and reducing the number of parts. Furthermore, by introducing prefill solution into the pipette 310, the heparin inside the pipette 310 can be diluted simultaneously, thereby simplifying the dilution process.

[0309] By employing a flexible drug delivery system 300, pipettes 310 and the like can be positioned away from the blood circuit. This increases the flexibility in the placement of pipettes 310 and the like. It can be configured to prevent interference with other devices, thereby improving user operability.

[0310] The drug delivery line 300 is suitable for both of the following processes: the dilution process of introducing pre-filled solution from the arterial side blood circuit 30 into the pipette 310; and the drug administration preparation process of dispensing diluted heparin from the pipette 310 into the arterial side blood circuit 30. Therefore, the number of parts can be reduced and the structure can be simplified.

[0311] <<<Variations>>>

[0312] The third embodiment illustrates an example where the blood purification device 70 includes a diaphragm pump 330, a liquid level regulating pump 340, a solenoid valve 370, and an extension 313. However, another structure is also possible, where the medication supply device 10C includes the diaphragm pump 330 and the extension 313. The diaphragm pump 330 and the liquid level regulating pump 340 may be controlled by the control device 66 of the blood purification device 70, but rather by the control device (not shown) of the medication supply device 10C.

[0313] The control unit of the liquid supply device 10C mainly includes: a processor (CPU (Central Processing Unit), etc.), ROM (Read-Only Memory), RAM (Random Access Memory), I / O (Input / Output Interface), I / F (Interface Device), auxiliary storage devices (HDD (Hard Disk Drive), SSD (Solid State Drive), etc.), and input operation devices (touch panel, keyboard), etc. The ROM stores programs and constants used for performing various processes such as control processing. The RAM temporarily stores the values ​​of variables used during program execution.

[0314] The control device of the liquid supply device 10C outputs various control signals and inputs various detection signals via I / O. For example, the control device outputs control signals to the liquid level regulating pump 340, solenoid valve 370, etc.

[0315] <<<Overall Processing Flow of Control Device 66>>>

[0316] Figure 11 This is a flowchart illustrating the overall processing flow of the control device 66. As described above, the drug supply devices 10A to 10C, under the control of the control device 66, sequentially execute the filling process, the dilution process, and the drug administration preparation process. Especially when heparin dilution is not required, the operator can control the process via the input section (…). Figure 10 The dilution process is omitted, and the process transitions from the filling process to the drug preparation process.

[0317] The processor of the control device 66 executes the filling process (step S111).

[0318] In step S113, if heparin is diluted (yes), the processor of control device 66 performs the dilution process (step S115).

[0319] In step S113, if heparin is not diluted (no), or after the dilution process is completed, the processor of the control device 66 executes the drug administration preparation process (step S117).

[0320] <<<<Scope of Implementation>>>>

[0321] The first to third embodiments are described herein. However, the descriptions and drawings that form part of this disclosure should not be construed as limiting. Various embodiments not described herein are also included.

[0322] In the examples described in the first to third embodiments, heparin (unfractionated heparin) was shown as an example of an anticoagulant, but the method is not limited to unfractionated heparin; low molecular weight heparin, argatroban, nafamostat mesylate, etc., may also be used. The appropriate method can be selected based on the drug's mechanism of action, half-life, side effects, and other characteristics.

[0323] <<<<Implementation Forms of the Invention>>>>

[0324] <<First Form>>

[0325] The first aspect relates to a drug supply device that supplies drug solution to blood circuits (e.g., arterial side blood circuit 30, venous side blood circuit 40, etc.) of a blood purification device (e.g., dialysis device body 60, etc.), which is used to purify blood.

[0326] The liquid medicine supply device is equipped with:

[0327] A composition holding section (e.g., pipette 110, 310, etc.) is capable of introducing an anticoagulant (e.g., heparin) contained within a container from a container and holding a composition containing at least the introduced anticoagulant; and

[0328] A connecting part (e.g., drug solution line 100, 200, 300, etc.) connects the composition holding part to the blood circuit, enabling the composition to be discharged from the composition holding part to the blood circuit.

[0329] A drug supply device is a device that supplies drug solutions to a blood circuit. A blood purification device for purifying blood has a blood circuit. The drug supply device has a composition holding part and a connecting part.

[0330] An anticoagulant can be introduced into the composition holding section. That is, an anticoagulant can be introduced into the composition holding section. The anticoagulant is stored in a container. The container is a generally used container for storing the anticoagulant. The container is a generally flowable container for storing the anticoagulant. The container has a shape and size suitable for storing the anticoagulant.

[0331] "Can be introduced" refers not only to the state in which the anticoagulant has been introduced into the composition holding section, but also to the state in which the anticoagulant has not yet been introduced into the composition holding section, but is in a preparatory state or potential state for introduction. These are also included in the drug supply device of the first form.

[0332] For example, this situation occurs when the anticoagulant in the container is separated from the composition holding part, but the composition holding part still inevitably comes into contact with the anticoagulant. Furthermore, even if the anticoagulant in the container has come into contact with the composition holding part, the anticoagulant will not be introduced into the composition holding part if the pump or other drive unit is not activated. However, if the drive unit is activated, the anticoagulant will be immediately introduced into the composition holding part. This situation is also included.

[0333] As mentioned above, "importable" also includes a preparatory state or potential state for introducing the anticoagulant from the container to the composition holding part.

[0334] The composition holding section is used to hold the composition, which contains at least an anticoagulant introduced into the composition holding section. The composition may consist of only the anticoagulant or may contain other components.

[0335] The composition holding section can both allow the anticoagulant to be introduced and hold the composition containing at least the introduced anticoagulant.

[0336] The connecting portion is used to connect the composition holding portion to the blood circuit, and the composition holding portion is connected to the blood circuit via the connecting portion. The connecting portion enables the composition to be discharged from the composition holding portion to the blood circuit. That is, the composition held in the composition holding portion can be discharged from the composition holding portion to the blood circuit via the connecting portion.

[0337] "Exportable" means not only that the composition has been exported to the blood circuit, but also that the composition has not yet been exported to the blood circuit but is in a preparatory or potential state for export, all of which are included in the first form of the drug supply device.

[0338] For example, this includes situations where the composition holding part is necessarily connected to the blood circuit even when it is disconnected from the blood circuit. Additionally, even when the composition holding part is connected to the blood circuit, the composition is not discharged into the blood circuit if components such as pumps and valves are not in the discharge state. However, this also includes situations where the composition is directly discharged into the blood circuit once the components are in the discharge state.

[0339] Thus, "exportable" means that it also includes a preparatory state or potential state for exporting the composition to the blood circuit.

[0340] The anticoagulant, typically contained in commercially available containers, can be transferred into the composition holding section, thus preventing the need to replace containers or discard the anticoagulant. This avoids the problems of cumbersome operation and anticoagulant waste.

[0341] <<Second Form>>

[0342] The second form is based on the first form.

[0343] The liquid level of the composition held in the composition holding section is detected using a liquid level detection device (e.g., liquid level detection device 150).

[0344] Since the liquid level of the composition is detected by the liquid level detection device, the amount of anticoagulant introduced into the composition holding section and the amount of remaining composition in the composition holding section can be obtained, thereby enabling appropriate control of the drug supply device. Blood purification devices may have a liquid level detection device, and drug supply devices or other devices may also have a liquid level detection device. It is acceptable as long as the blood purification device or liquid supply device can be controlled based on the liquid level of the composition detected by the liquid level detection device.

[0345] <<Third Form>>

[0346] The third form is based on the first or second form.

[0347] The composition in the composition holding section is found to be empty using an empty-liquid detection device (such as an empty-liquid detection device 160).

[0348] Since the empty / liquid detection device can detect when the composition is empty, it is possible to reasonably determine whether to introduce anticoagulant into the composition holding section, or whether to stop discharging the composition. Blood purification devices can have empty / liquid detection devices, as can drug supply devices or other devices. The key is that the blood purification device or drug supply device can be controlled based on the detection results from the empty / liquid detection device.

[0349] <<Fourth Form>>

[0350] The fourth form is based on any one of the first to third forms.

[0351] It is possible to introduce a diluent (e.g., pre-filled liquid) into the composition holding section.

[0352] The composition, diluted with the introduced diluent, can be held within the composition holding section.

[0353] The composition holding section can be used to introduce not only anticoagulants but also diluents. By introducing the diluent into the anticoagulant introduced into the composition holding section, the anticoagulant can be diluted within the composition holding section, and the diluted anticoagulant can be held as part of the composition within the composition holding section.

[0354] "Can be introduced" refers not only to the state in which the diluent has been introduced into the composition holding section, but also to the state in which the diluent has not yet been introduced into the composition holding section but is in a preparatory state or potential state for introduction. These are also included in the fourth form of the drug supply device.

[0355] For example, this includes situations where the composition holding section is necessarily connected to the blood circuit even when it is disconnected from the blood circuit. Additionally, even when the composition holding section is connected to the blood circuit, if components such as pumps and valves are not in the input state, the diluent will not be introduced into the composition holding section. However, this also includes situations where, once the components are in the input state, the diluent will be directly introduced into the composition holding section.

[0356] Thus, "importable" means that it also includes a preparatory state or potential state for introducing the diluent from the blood circuit to the composition holding part.

[0357] The diluent can be introduced into the composition holding part from the blood circuit via the connection part, but the diluent introduction path is not limited to this, as long as it is a tube that can introduce the diluent into the composition holding part.

[0358] <<Fifth Form>>

[0359] The fifth form, in addition to any of the first to fourth forms, also possesses:

[0360] A first connecting portion (e.g., extension 113, first lower opening 316, etc.) connects the container to the composition holding portion, enabling the introduction of the anticoagulant contained in the container into the composition holding portion; and

[0361] A second connecting portion (e.g., lower end opening 116, second lower end opening 318, etc.) connects the composition holding portion and the connecting portion, enabling the composition held in the composition holding portion to be exported to the connecting portion.

[0362] The fifth type of liquid medicine supply device has a first connecting part and a second connecting part.

[0363] The first connecting portion connects the container and the composition holding portion. The first connecting portion is capable of introducing the anticoagulant contained in the container into the composition holding portion. The anticoagulant contained in the container is introduced into the composition holding portion via the first connecting portion.

[0364] In addition, the meaning of "importable" in the fifth form is the same as that in the first form.

[0365] The second connecting portion connects the composition holding portion and the connecting portion. The second connecting portion allows the composition held in the composition holding portion to be exported to the connecting portion. The composition held in the composition holding portion can be exported to the connecting portion via the second connecting portion.

[0366] In addition, the meaning of "derivative" in the fifth form is the same as that in the first form.

[0367] By clamping the composition in the middle and separately setting up the flow path for the anticoagulant and the flow path for the composition and diluent, the concentration, cleanliness, and other states of the anticoagulant stored in the container can be kept stable.

[0368] <<Sixth Form>>

[0369] The sixth form, based on any one of the first to fifth forms, has the following characteristics in the second connecting portion:

[0370] The diluent introduction state of introducing diluent into the composition holding section, and

[0371] The composition is exported to the composition export state of the connector.

[0372] The second connecting portion can be used simultaneously for both the diluent introduction state and the composition export state. The diluent introduction state is the state in which diluent is introduced into the composition holding portion via the connecting portion. The composition export state is the state in which the composition is exported from the connecting portion to the connecting portion. By sharing the second connecting portion, the structure can be simplified.

[0373] <<Seventh Form>>

[0374] In the seventh form, based on any of the first to sixth forms, the blood circuit further includes a diaphragm pump (e.g., diaphragm pump 130), which controls the flow of liquid within the blood circuit by deforming the diaphragm.

[0375] Because the flow of liquid within the blood circuit is controlled by a diaphragm pump inherent in the blood circuit, there is no need for an additional drive device to control the flow of liquid, allowing the diluent to be introduced into the composition holding section or the composition to be exported to the connecting section. By using a shared diaphragm pump, the structure of the drug supply device can be simplified.

[0376] <<Eighth Form>>

[0377] The eighth form, based on any of the first to seventh forms, also includes a dripping chamber (e.g., dripping chamber 210), which separates the continuously flowing composition into individual droplets and allows them to drip down by gravity.

[0378] The composition dripping from the dripping cavity is detected using a dripping sensor (e.g., dripping sensor 220, etc.).

[0379] Since commonly used components such as dialysis equipment can be used to deliver the composition from the composition holding section to the blood circuit, a drug delivery device can be easily and simply constructed. The blood purification device can have a drip sensor, and the drug delivery device or other devices can also have a drip sensor. This is as long as the blood purification device or drug delivery device can be controlled based on the detection result detected by the drip sensor.

[0380] <<Ninth Form>>

[0381] Based on any of the first to eighth embodiments, the ninth embodiment has a diaphragm pump (e.g., diaphragm pump 330) disposed in an extension (e.g., extension 313) away from the composition holding portion, which controls the flow of air within the extension by means of deformation of the diaphragm.

[0382] "Flowable" means not only that air is flowing, but also that air is not yet flowing, but is in a preparatory or potential state for flow, all of which are included in the ninth form of the liquid supply device.

[0383] For example, if components such as pumps and valves are not in a flowable state, air will not flow within the extension. However, this also includes the case where air will immediately flow within the extension once the components are in a flowable state.

[0384] Thus, "flowable" also includes the preparatory state and potential state in which air flows within the extension.

[0385] Even if the blood circuit does not have a driving device such as a diaphragm pump, it can be configured such that an additional diaphragm pump is installed on the blood circuit to realize the introduction of anticoagulant, the introduction of diluent, and the export of composition.

[0386] The extension may or may not be included in the liquid supply device.

[0387] <<Tenth Form>>

[0388] The tenth form is based on any one of the first to ninth forms.

[0389] The first connecting portion has a protrusion in the shape of a long cylindrical strip (e.g., extension 113, etc.).

[0390] The protrusion has an opening at the front end furthest from the composition holding portion, which allows passage through a through hole in the container.

[0391] The first connecting portion has a protrusion extending from the composition holding portion. The protrusion has an opening. This opening can pass through a through hole in the container. The opening is located at the front end furthest from the composition holding portion.

[0392] "Can pass through" refers not only to the state where the opening has passed through the through hole, but also to the state where the opening has not passed through the through hole but is in a preparatory or potential state for passing through. These are also included in the tenth form of the liquid supply device.

[0393] For example, the situation where the opening can still pass through the through hole even when the opening is separated from the through hole is an example of this.

[0394] Thus, "passable" also includes the preparatory state and potential state for the opening to be passed through by the through hole.

[0395] By positioning the protrusion inside the container through the through hole, the anticoagulant contained in the container can be directly introduced into the composition holding part through the opening. The anticoagulant can be used without processing the container or transferring it to another container, which simplifies the operation.

[0396] Furthermore, the protrusion is preferably a structure whose outer diameter gradually tapers away from the composition holding part, which can accommodate the size of various through holes in the container and broaden the types of containers that can be used with the first connecting part.

[0397] <<Eleventh Form>>

[0398] The eleventh form, based on any of the first to tenth forms, is a method for supplying medication. This method involves supplying medication to blood circuits (e.g., arterial side blood circuit 30, venous side blood circuit 40, etc.) of a blood purification device (such as the main body 60 of a dialysis device), which is used to purify blood.

[0399] The method for supplying the drug solution includes:

[0400] The anticoagulant introduction step involves introducing an anticoagulant (e.g., heparin) contained in a container from the container into a composition holding section (e.g., pipette 110, 310, etc.).

[0401] A composition holding step, wherein a composition containing at least an anticoagulant introduced into the composition holding portion is held in the composition holding portion; and

[0402] The composition export step involves exporting the composition from the composition holding part to the blood circuit via a connection part (e.g., a drug line 100, 200, 300, etc.) that connects the composition holding part to the blood circuit.

[0403] It can direct the anticoagulant contained in a conventionally used, commercially available container into the composition holding section, thus preventing the need for refilling, bottle changing, and discarding of the anticoagulant. This prevents cumbersome operations and the waste of anticoagulant.

[0404] <<Twelfth Form>>

[0405] The twelfth embodiment, based on any one of the first to eleventh embodiments, further includes a composition liquid level detection step, wherein the liquid level of the composition held within the composition holding portion is detected.

[0406] Since the liquid level of the composition is detected by the liquid level detection device, the amount of anticoagulant introduced into the composition holding part and the amount of the remaining composition in the composition holding part can be obtained, thereby enabling the control of the liquid supply device.

[0407] <<Thirteenth Form>>

[0408] The thirteenth form, based on any one of the first to twelfth forms, further includes an empty liquid detection step, wherein the composition holding portion is detected to be empty.

[0409] Since the empty liquid detection device can detect that the composition is empty, it is possible to reasonably determine whether to introduce anticoagulant into the composition holding section, and whether to stop the discharging of the composition.

[0410] <<The Fourteenth Form>>

[0411] The fourteenth form, in addition to any of the first to thirteenth forms, also includes:

[0412] A diluent introduction step for introducing a diluent (e.g., pre-filled liquid) into the composition holding portion; and

[0413] The dilution holding step involves holding the diluted composition within the composition holding section, where the diluted composition is held by the introduced diluent.

[0414] The composition holding section can not only introduce anticoagulants but also diluents. By introducing diluents into the anticoagulants introduced into the composition holding section, the anticoagulants can be diluted within the composition holding section, and the diluted anticoagulants can be held as a composition within the composition holding section.

[0415] <<Fifteenth Form>>

[0416] The fifteenth form, in addition to any of the first through fourteenth forms, also includes:

[0417] An introduction step in which the anticoagulant contained in the container is introduced into the composition holding part via a first communication portion (e.g., extension 113, first lower opening 316, etc.) connecting the container and the composition holding part; and

[0418] The export step involves exporting the composition held in the composition holding part to the connection part via a second communication part (e.g., lower end opening 116, second lower end opening 318, etc.) that connects the composition holding part and the connection part.

[0419] By clamping the composition in the middle and separately setting up the flow path for the anticoagulant and the flow path for the composition and diluent, the concentration, cleanliness, and other states of the anticoagulant stored in the container can be kept stable.

[0420] <<Sixteenth Form>>

[0421] The sixteenth form, in addition to any of the first to fifteenth forms, also includes:

[0422] The diluent introduction step, in which the diluent is introduced into the composition holding portion via the second connecting portion; and

[0423] The composition export step involves exporting the composition to the connecting portion via the second connecting portion.

[0424] The second connecting portion can be used simultaneously for both the diluent introduction step and the composition export step. The diluent introduction step is the step of introducing diluent into the composition holding portion via the connecting portion. The composition export step is the step of exporting the composition to the connecting portion via the connecting portion. By sharing the second connecting portion, the structure can be simplified.

[0425] <<Seventeenth Form>>

[0426] The seventeenth embodiment, based on any one of the first to sixteenth embodiments, further includes a liquid flow control step, wherein the flow of liquid in the blood circuit is controlled by the deformation of the diaphragm of the diaphragm pump (e.g., diaphragm pump 130).

[0427] Because the flow of liquid within the blood circuit is controlled by a diaphragm pump inherent in the blood circuit, no additional drive device for controlling the flow of liquid is required to introduce the diluent into the composition holding section or to export the composition to the connecting section. Using a shared diaphragm pump simplifies the structure of the drug delivery device.

[0428] <<The Eighteenth Form>>

[0429] The eighteenth form, in addition to any of the first to seventeenth forms, also includes:

[0430] The dripping step, wherein the continuously flowing composition is separated into individual droplets and allowed to drip by gravity; and

[0431] A step for detecting a droplet composition, wherein the dropped composition is detected.

[0432] Since the composition can be dispensed from the composition holding section to the blood circuit using readily available and commonly used components such as dialysis equipment, it is easy and simple to construct a drug supply device.

[0433] <<The Nineteenth Form>>

[0434] The nineteenth embodiment, based on any one of the first to eighteenth embodiments, further includes a liquid flow control step, wherein the flow of air within the extension is controlled by deformation of the diaphragm of a diaphragm pump (e.g., diaphragm pump 330) disposed on an extension that is remote from the composition holding portion and allows air flow.

[0435] Even if the blood circuit does not have a driving component such as a diaphragm pump, it can be configured such that an additional diaphragm pump is installed on the blood circuit to achieve the introduction of anticoagulant, the introduction of diluent, and the export of composition.

[0436] Industrial availability

[0437] The present invention provides a drug supply device that is not limited by the packaging material of drugs such as heparin, and can use a single package of drug solution for multiple treatments.

[0438] Cross-references to related applications

[0439] This application claims priority to Japanese Patent Application No. 2023-209695, filed with the Japanese Patent Office on December 12, 2023, the entire disclosure of which is incorporated herein by reference.

[0440] Explanation of symbols

[0441] 10A, 10B, 10C Liquid Supply Devices

[0442] 20 dialyzers

[0443] 60 Main body of dialysis device

[0444] 70 Blood purification devices

[0445] 110 Pipettes

[0446] 130 Diaphragm Pump

[0447] 140 Liquid level regulating pump.

Claims

1. A medication supply device that supplies medication to a blood circuit of a blood purification device for purifying blood, wherein... The liquid medicine supply device includes: A composition holding section, capable of introducing an anticoagulant contained within a container from a container and holding a composition containing at least the introduced anticoagulant; and A connecting portion that connects the composition holding portion to the blood circuit, enabling the composition to be exported from the composition holding portion to the blood circuit.

2. The liquid medicine supply device according to claim 1, wherein, The liquid level of the composition held in the composition holding section is detected using a liquid level detection device.

3. The liquid medicine supply device according to claim 1, wherein, The composition holding section is found to be empty using an empty-liquid detection device.

4. The pharmaceutical solution supply device according to claim 1, which is capable of introducing a diluent into the composition holding section. The composition, diluted with the introduced diluent, can be held within the composition holding section.

5. The liquid medicine supply device according to claim 1, further comprising: A first connecting portion, connecting the container and the composition holding portion, is capable of introducing the anticoagulant contained in the container into the composition holding portion; and A second connecting portion connects the composition holding portion and the connecting portion, enabling the composition held in the composition holding portion to be exported to the connecting portion.

6. The liquid medicine supply device according to claim 5, wherein, The second connecting portion has: The diluent introduction state of introducing diluent into the composition holding section, and The composition is exported to the composition export state of the connector.

7. The liquid medicine supply device according to claim 1, wherein, The blood circuit also includes a diaphragm pump, which controls the flow of liquid within the blood circuit by deforming the diaphragm.

8. The liquid medicine supply device according to claim 1 further comprises a dripping chamber, wherein the dripping chamber separates the continuously flowing composition into independent droplets and causes them to drip down by gravity; The composition dripping from the dripping cavity is detected using a drip sensor.

9. The liquid medicine supply device according to claim 1, wherein, An extension away from the composition holding portion is provided with a diaphragm pump, which controls the flow of air within the extension by deformation of the diaphragm.

10. The liquid medicine supply device according to claim 5, wherein, The first connecting portion has a protrusion in the shape of a long cylindrical strip; The protrusion has an opening at the front end furthest from the composition holding portion, which allows passage through a through hole in the container.

11. A method for supplying a drug solution, the method comprising supplying a drug solution to a blood circuit of a blood purification device for purifying blood, the method comprising: The anticoagulant introduction step involves introducing an anticoagulant contained in a container from the container into a composition holding section; A composition holding step, wherein a composition containing at least an anticoagulant introduced into the composition holding portion is held in the composition holding portion; and The composition export step involves exporting the composition from the composition holding part to the blood circuit via a connecting part that connects the composition holding part to the blood circuit.

12. The method for supplying a pharmaceutical solution according to claim 11 further includes a step of detecting the liquid level of the composition, wherein, The liquid level of the composition held within the composition holding section is detected.

13. The method for supplying liquid medicine according to claim 11 further includes an empty liquid detection step, wherein, The composition holding section was found to be empty.

14. The method for supplying liquid medicine according to claim 11, further comprising: The diluent introduction step involves introducing a diluent into the composition holding portion; as well as The dilution holding step involves holding the diluted composition within the composition holding section, where the diluted composition is held by the introduced diluent.

15. The method for supplying liquid medicine according to claim 11, further comprising: An introduction step in which the anticoagulant contained in the container is introduced into the composition holding part via a first communication part connecting the container and the composition holding part; as well as The export step involves exporting the composition held in the composition holding part to the connection part via a second communication part that connects the composition holding part and the connection part.

16. The method for supplying liquid medicine according to claim 15, further comprising: A diluent introduction step in which a diluent is introduced into the composition holding portion via the second communicating portion; as well as The composition export step involves exporting the composition to the connecting portion via the second connecting portion.

17. The method for supplying a pharmaceutical solution according to claim 11 further includes a liquid flow control step, wherein, The flow of fluid within the blood circuit is controlled by the deformation of the diaphragm in the diaphragm pump.

18. The liquid medicine supply device according to claim 11, further comprising: The dripping step, wherein the continuously flowing composition is separated into individual droplets and allowed to drip by gravity; and A step for detecting a droplet composition, wherein the dropped composition is detected.

19. The method for supplying a pharmaceutical solution according to claim 11, further comprising a liquid flow control step, wherein, The airflow within the extension is controlled by the deformation of the diaphragm of a diaphragm pump located on an extension that is remote from the composition holding portion and allows airflow.

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