Medicine liquid supply device and medicine liquid dilution method
The chemical solution supply device addresses the limitations of conventional heparin use by enabling flexible packaging and multiple treatments, facilitating efficient and versatile anticoagulant administration in dialysis systems.
Patent Information
- Application Number
- JP2023209695
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2023-12-12
- Publication Date
- 2025-06-24
AI Technical Summary
Conventional systems for using heparin as an anticoagulant in dialysis are limited by the need for specific vial shapes and sizes, restricting the use of alternative packaging materials and allowing only single-use treatments.
A chemical solution supply device that connects to a blood purification device, allowing for the introduction of heparin from any container, dilution with a priming solution, and administration to the blood circuit, thereby overcoming packaging material limitations and enabling multiple treatments.
The device allows for flexible use of heparin with various packaging materials and supports multiple treatment cycles, reducing waste and operational complexity.
Smart Images

Figure 2025093809000001_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to a chemical solution supply device and a chemical solution dilution method.
Background Art
[0002] Heparin may be used as an anticoagulant for blood in a dialysis device or the like. Generally, heparin is stored in a vial and delivered. In a system using heparin stored in a vial, heparin can be used immediately from the vial by setting the vial in the device (see, for example, Patent Document 1).
Prior Art Documents
Patent Documents
[0003]
Patent Document 1
Summary of the Invention
Problems to be Solved by the Invention
[0004] In the conventional system, the vial was set in the device. For this reason, only vials having a certain shape and size that can be used in the system had to be used. For this reason, the packaging material for heparin was limited to vials. Furthermore, it was only possible to perform treatment using the heparin in the packaging unit, and it was difficult to perform treatment multiple times.
[0005] The present invention has been made in view of the above points. An object of the present invention is to provide a chemical solution supply device that is less restricted in the packaging material for chemical solutions such as heparin and can be used for multiple treatments with the chemical solution in the packaging unit.
Means for Solving the Problems
[0006] The chemical solution supply device according to the present invention is characterized in that it is a chemical solution supply device that supplies a chemical solution to a blood circuit of a blood purification device that purifies blood, An anticoagulant contained in a container is introducible from the container, and a composition holding part that holds a composition containing at least the introduced anticoagulant. A connecting part that connects the composition holding part to the blood circuit and enables the composition to be led out from the composition holding part to the blood circuit.
Advantages of the Invention
[0007] It is less likely to be restricted by the packaging material of chemical solutions such as heparin, and can be used for multiple treatments with the chemical solution in the packaging unit.
Brief Description of the Drawings
[0008]
Figure 1
Figure 2
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Figure 10
Figure 11
Mode for Carrying Out the Invention
[0009] <<<<<Outline of the Present Embodiment>>>>> Conventionally, in dialysis treatment, heparin has been used as an anticoagulant for blood. Heparin is often delivered in vials or filled into syringes.
[0010] When using heparin contained in a vial, the vial is directly set on the device to administer heparin. However, it has been difficult to use packaging materials other than vials corresponding to the device. Also, with a general vial, all of the heparin contained therein had to be used up in one treatment, and it was difficult to use heparin over multiple treatments.
[0011] Packaging materials such as vials often depend on the device in terms of the size and shape of the packaging material, and there have been few options for the packaging materials that can be used.
[0012] As described above, there has been a demand for a device or system that can increase the options for packaging materials so that the desired heparin can be used, and that can use the packaging material in multiple portions.
[0013] <<<<<Details of the Present Embodiment>>>>> Hereinafter, as embodiments, the first to third embodiments will be described with reference to the drawings.
[0014] <<Direction>> <Upward direction, upper side, upward, above, etc.> The upward direction is the direction opposite to the downward direction described later, and is the direction opposite to the direction of gravity.
[0015] <Downward direction, lower side, downward, below, etc.> The downward direction is the direction of gravity. That is, the downward direction is the direction indicated by a string suspending an object.
[0016] <Vertical direction> The vertical direction is the direction along the upward and downward directions. Regardless of the orientation, it suffices if it is along the upward and downward directions.
[0017] <Longitudinal direction> In a member having an elongated shape or the like, it refers to the direction in which it extends long. It refers to the direction in which the longest part or region extends.
[0018] <Transverse direction> In a member having an elongated shape or the like, it refers to the direction in which it extends short, for example, a direction perpendicular to the longitudinal direction. It refers to the direction in which the shortest part or region extends.
[0019] <<<<First Embodiment>>>> <<<Configuration of Blood Purification Device 70>>> FIG. 1 is a schematic diagram showing the configuration of the chemical solution supply device 10A according to the first embodiment. The chemical solution supply device 10A of the first embodiment is connected to the blood purification device 70 and applied to a hemodialysis device.
[0020] The blood purification device 70 mainly includes a dialyzer 20 having a blood purification function, a blood circuit to which an arterial side blood circuit 30 and a venous side blood circuit 40 are connected, a blood pump 50, a dialysis device main body 60 to which a dialysate introduction line 62 and a dialysate discharge line 64 are connected, a control device 66, chemical solution clamp means 120, a diaphragm pump 130, a liquid level adjustment pump 140, a liquid level detection device 150, an air detection device 160, and has.
[0021] <Dialyzer 20> The dialyzer 20 has a blood purification membrane (not shown). The blood purification membrane may be a hollow fiber type hemodialysis membrane or hemodiafiltration membrane, or a flat membrane type hemodialysis membrane. The dialyzer 20 has a blood inlet 22 and a blood outlet 24. The blood inlet 22 is an opening for introducing blood into the dialyzer 20. The blood outlet 24 is an opening for discharging the blood introduced into the dialyzer 20. Further, the dialyzer 20 has a dialysate inlet 26 and a dialysate outlet 28. The dialysate inlet 26 is an opening for introducing dialysate into the dialyzer 20. The dialysate outlet 28 is an opening for discharging the dialysate introduced into the dialyzer 20. The dialyzer 20 purifies the blood by bringing the dialysate into contact with the blood introduced from the blood inlet 22 through the blood purification membrane.
[0022] <Arterial side blood circuit 30> The arterial side blood circuit 30 mainly has a flexible and long tube. 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. The blood collected from the patient's blood vessel is guided into the blood purification membrane of the dialyzer 20 through the blood inlet 22 of the dialyzer 20 from the first end 32 of the arterial side blood circuit 30. A connector (not shown) for attaching an arterial side puncture needle (not shown) can be provided at the second end 34 of the arterial side blood circuit 30.
[0023] <Venous side blood circuit 40> Similar to the arterial side blood circuit 30, the venous side blood circuit 40 mainly has a flexible and long tube. The venous side blood circuit 40 has a first end 42 and a second end 44 and has an air trap chamber (not shown) in the middle. The first end 42 of the venous side blood circuit 40 is connected to the blood outlet 24 of the dialyzer 20. The blood that has passed through the blood purification membrane is discharged from the blood outlet 24 of the dialyzer 20. A connector (not shown) for attaching a venous side puncture needle (not shown) can be provided at the second end 44 of the venous side blood circuit 40.
[0024] <Blood pump 50> The blood pump 50 is disposed between the first end 32 and the second end 34 of the arterial blood circuit 30. The blood pump 50 is constituted by a tube pump. The tube pump has a rotatable roller (not shown). By crushing the tube with the rotating roller, the blood and the priming liquid in the tube of the arterial blood circuit 30 are caused to flow.
[0025] <Extracorporeal circulation> The blood of the patient collected by the arterial puncture needle reaches the dialyzer 20 through the arterial blood circuit 30, and after blood purification, it flows through the venous blood circuit 40 and returns to the patient's body through the venous puncture needle. Thereby, extracorporeal circulation is performed.
[0026] <Arterial side and venous side> The side of the puncture needle for blood withdrawal (blood collection) is referred to as the "arterial side", and the side of the puncture needle for blood return is referred to as the "venous side". Therefore, whether it is referred to as the "arterial side" or the "venous side" is not determined by whether the blood vessel to be punctured is an artery or a vein.
[0027] <Arterial clamp means 36 and venous clamp means 46> At the tip of the arterial blood circuit 30, arterial clamp means 36 capable of opening and closing the flow path of the arterial blood circuit 30 is disposed. At the tip of the venous blood circuit 40, venous clamp means 46 capable of opening and closing the flow path of the venous blood circuit 40 is disposed. The arterial clamp means 36 and the venous clamp means 46 are controlled to be in an open state or a closed state by a control signal output from the control device 66.
[0028] <Dialysate introduction line 62 and dialysate discharge line 64> A dialysis fluid inlet line 62 is connected to the dialysis fluid inlet 26 of the dialyzer 20. A dialysis fluid discharge line 64 is connected to the dialysis fluid outlet 28 of the dialyzer 20. The dialysis fluid can be introduced into the dialyzer 20 via the dialysis fluid inlet line 62, pass through the outside of the hollow fiber membrane, and be discharged from the dialysis fluid discharge line 64. The inside of the hollow fiber membrane (purification membrane) of the dialyzer 20 forms a blood flow path through which blood can flow, and the outside of the hollow fiber membrane forms a dialysis fluid flow path through which dialysis fluid can flow.
[0029] <Dialysis device main body 60> The dialysis device main body 60 has a dialysis fluid inlet line 62 and a dialysis fluid discharge line 64 extending therefrom. The dialysis device main body 60 has a liquid delivery pump and a water removal pump (both not shown). The liquid delivery pump introduces the dialysis fluid prepared to a predetermined concentration into the dialyzer 20 and discharges the dialysis fluid after dialysis from the dialyzer 20. The water removal pump removes water from the blood flowing in the dialyzer 20.
[0030] <Control device 66> FIG. 10 is a functional block diagram for explaining the overall function of the dialysis device main body 60 including the control device 66. The dialysis device main body 60 includes an input unit, a control device 66, and an output unit.
[0031] The input unit is a device or component that can be operated by an operator of the dialysis device main body 60, such as a touch panel or a keyboard. The operator can input data or input instructions for control from the input unit. When the input unit detects an input operation by the operator, it outputs a detection signal corresponding to the input operation to the control device 66.
[0032] The control device 66 mainly includes a processor (such as a CPU (Central Processing Unit)), a ROM (Read Only Memory), a RAM (Random Access Memory), an I / O (Input / Output Interface), an I / F (Interface Device), an auxiliary storage device (such as an HDD (Hard Disk Drive) or an SSD (Solid State Drive)), etc. Programs and constants for executing various processes such as control processing are stored in the ROM. When a program is executed, values of variables used are temporarily stored in the RAM.
[0033] The output unit mainly includes a blood pump 50, a liquid level adjustment pump 140, a chemical solution clamp means 120, an arterial clamp means 36, and a solenoid valve 370 (in the third embodiment described later). When the operator operates the input unit, the input unit outputs a detection signal corresponding to the input operation to the control device 66, and the control device 66 can output a control signal to the output unit to control the output unit.
[0034] The control device 66 outputs various control signals and inputs various detection signals via the I / O. For example, the control device 66 outputs control signals to the chemical solution clamp means 120, the diaphragm pump 130, the liquid level adjustment pump 140, etc., which will be described later. Also, the control device 66 inputs detection signals from a liquid level detection device 150, an air detection device 160, etc.
[0035] <<Chemical Solution Clamp Means 120>> The chemical solution clamp means 120 is provided on the chemical solution line 100 (described later) of the chemical solution supply device 10A. The chemical solution clamp means 120 can be in either an open state or a closed state. When the chemical solution clamp means 120 is in the open state, liquid can flow in the chemical solution line 100. When the chemical solution clamp means 120 is in the closed state, liquid cannot flow in the chemical solution line 100.
[0036] The chemical solution clamping means 120 has a driving device (not shown) such as a solenoid or a motor. The chemical solution clamping means 120 is driven by a control signal output from the control device 66 to be in an open state or a closed state.
[0037] <<Diaphragm pump 130>> The diaphragm pump 130 has a deformable diaphragm 131. The diaphragm pump 130 controls the flow of liquid by deforming the diaphragm 131. The diaphragm 131 of the diaphragm pump 130 is driven by the liquid level adjusting pump 140. The diaphragm pump 130 presses or sucks the diaphragm 131 by the liquid level adjusting pump 140. By deforming the diaphragm 131 by pressing or sucking the diaphragm 131, a positive pressure or a negative pressure is generated in the arterial side blood circuit 30 or the venous side blood circuit 40, thereby controlling the flow of liquid in the arterial side blood circuit 30 and the venous side blood circuit 40. The diaphragm pump 130 can repeat pressing and sucking by the liquid level adjusting pump 140.
[0038] In the first embodiment, the diaphragm pump 130 is provided in both the arterial side blood circuit 30 and the venous side blood circuit 40. In the first embodiment, mainly, the diaphragm pump 130 provided in the arterial side blood circuit 30 is used. The diaphragm pump 130 can cause the liquid to flow in the arterial side blood circuit 30.
[0039] <<Liquid level adjusting pump 140>> The liquid level adjusting pump 140 deforms the diaphragm 131 of the diaphragm pump 130. The liquid level adjusting pump 140 presses or sucks the diaphragm 131 of the diaphragm pump 130.
[0040] The liquid level adjusting pump 140 has a driving device (not shown) such as a solenoid or a motor. The liquid level adjusting pump 140 is driven by a control signal output from the control device 66 to press or suck.
[0041] <<Liquid level detection device 150>> The liquid level detection device 150 can detect the amount of undiluted heparin or diluted heparin introduced into the pipette 110. The liquid level detection device 150 outputs a signal indicating the liquid level to the control device 66.
[0042] <<Empty detection device 160>> The empty detection device 160 can detect whether undiluted heparin or diluted heparin is present in the pipette 110. The empty detection device 160 outputs a signal indicating the absence of heparin or diluted heparin. By providing the empty detection device 160, in the administration preparation process described later, diluted heparin can be derived until the pipette 110 becomes empty, so that waste due to the remaining chemical solution can be reduced. Furthermore, since the derivation of diluted heparin can be stopped when the pipette 110 becomes empty, the risk of air entering the arterial blood circuit 30 can be reduced.
[0043] <<<Drugs, etc.>>> <Heparin (anticoagulant)> In dialysis treatment, heparin is used as an anticoagulant. Usually, it is delivered in a form enclosed in a syringe or the like.
[0044] <Priming solution (diluent)> In dialysis treatment, physiological saline, dialysis fluid, etc. are used as the priming solution. In dialysis treatment, heparin is diluted by the priming solution.
[0045] <<<Configuration of the chemical solution supply device 10A>>> The chemical solution supply device 10A can be provided outside the blood circuit and can be used with fewer modifications to the previous blood circuit.
[0046] The chemical solution supply device 10A mainly includes, as shown in FIG. 1, a chemical solution line 100, a pipette 110, and has.
[0047] <<Liquid medicine line 100>> The liquid medicine line 100 is connected to the blood circuit. Liquid can flow between the liquid medicine line 100 and the blood circuit. The liquid can be, but is not limited to, a priming liquid, diluted heparin, etc. For example, the liquid medicine line 100 is connected to and communicates with the arterial blood circuit 30. The liquid medicine line 100 is preferably composed of a flexible tube or the like. The pipette 110 can be arranged at a position separated from the arterial blood circuit 30.
[0048] The liquid medicine line 100 is connected to the arterial blood circuit 30 at the connection part 180. The liquid medicine line 100 is preferably detachably connected at the connection part 180. The liquid medicine line 100 can be used as a disposable instrument.
[0049] <<Pipette 110>> Heparin and a priming liquid are introduced into the pipette 110. Inside the pipette 110, the heparin is diluted by the priming liquid. The pipette is an instrument for containing or temporarily storing a small amount of liquid and moving it. The pipette may have a scale for measurement. By using the scale for measurement, the volume can be measured simply and conveniently. The pipette can be used as a disposable instrument. Note that it is not limited to the pipette, and any container that can temporarily contain heparin and a priming liquid and can discharge undiluted heparin or diluted heparin may be used.
[0050] The pipette 110 has an overall long shape. The pipette 110 is arranged such that its longitudinal direction is along the vertical direction. The pipette 110 is provided so that it can be turned upside down. The pipette 110 can be in either an upright state or an inverted state. The upright state is a state in which the upper end opening 114 (described later) of the pipette 110 opens upward, and it is the state of the pipette 110 in the administration preparation step (see FIG. 4) and the dilution step (see FIG. 3). The inverted state is a state in which the upper end opening 114 of the pipette 110 opens downward, and it is the state of the pipette 110 in the filling step (see FIG. 2).
[0051] The operation of inverting the pipette 110 up and down may be manual or may use a driving device (not shown) such as a motor. The control device 66 of the blood purification device 70 outputs a control signal for inverting the pipette 110 up and down to a driving device such as a motor. When the control device 66 of the blood purification device 70 outputs an upright command signal, the pipette 110 is brought into an upright state by a driving device such as a motor. By outputting the upright command signal, the control device 66 can determine that the state of the pipette 110 is the upright state. When the control device 66 of the blood purification device 70 outputs an inverted command signal, the pipette 110 is brought into an inverted state by a driving device such as a motor. By outputting the inverted command signal, the control device 66 can determine that the state of the pipette 110 is the inverted state.
[0052] Further, a sensor (not shown) for detecting whether the pipette 110 is in either the upright state or the inverted state may be provided. The sensor may be an optical type, a mechanical type, or any other detection method as long as it can detect the upright state or the inverted state of the pipette 110 and output a signal indicating the detection result. The control device 66 of the blood purification device 70 can acquire the state of the pipette 110 by receiving the signal indicating the detection result emitted from the sensor. Even when a malfunction occurs in a driving device such as a motor, the state of the pipette 110 can be accurately acquired.
[0053] Furthermore, when the operator manually turns the pipette 110 upside down, after the operation of turning it upside down is completed, the operator operates the touch panel. For example, when the operator sets the pipette 110 in the upright state, the operator inputs information indicating that it is in the upright state to the touch panel. By this operation, the touch panel outputs a signal indicating that it is in the upright state to the control device. Thereby, the control device 66 can determine that the state of the pipette 110 is the upright state. On the other hand, when the operator sets the pipette 110 in the inverted state, the operator inputs information indicating that it is in the inverted state to the touch panel. By this operation, the touch panel outputs a signal indicating that it is in the inverted state to the control device. Thereby, the control device 66 can determine that the state of the pipette 110 is the inverted state.
[0054] The pipette 110 mainly has a housing portion 112, an extension portion 113, an upper end opening 114, and a lower end opening 116.
[0055] <Housing portion 112> The housing portion 112 has a long, substantially cylindrical shape. Heparin and priming liquid are introduced into the housing portion 112. When the priming liquid is introduced into the housing portion 112, in the housing portion 112, the heparin is diluted by the priming liquid. Also, when the priming liquid is not introduced into the housing portion 112, in the housing portion 112, the heparin is not diluted by the priming liquid and is simply in a state where the heparin is contained.
[0056] <Extension portion 113> The extending portion 113 has a long, substantially cylindrical shape. The extending portion 113 extends in a direction away from the accommodating portion 112 at the upper part of the accommodating portion 112. The extending portion 113 has a diameter smaller than that of the accommodating portion 112. By making the extending portion 113 thinner than the accommodating portion 112, it becomes easier to insert and extract the extending portion 113 into and from the openings of various containers. This enables correspondence with containers having various shapes and sizes, and the heparin contained therein can be introduced into the pipette 110. In particular, it is preferable that the extending portion 113 is formed to be tapered (become thinner) as it separates from the accommodating portion 112. This makes it even easier to insert and extract the extending portion 113 into and from the openings of various containers.
[0057] The extending portion 113 is arranged concentrically with the accommodating portion 112. That is, the extending portion 113 is arranged such that the central axis of the extending portion 113 coincides with the central axis of the accommodating portion 112.
[0058] <Upper end opening 114> The extending portion 113 has an upper end opening 114 at its upper end (the portion most distant from the accommodating portion 112). The upper end opening 114 communicates with the accommodating portion 112 and the extending portion 113. The upper end opening 114 can be connected to a vial (see Figure 2). The heparin stored in the vial is introduced into the accommodating portion 112 through the upper end opening 114 via the extending portion 113.
[0059] In the normal upright state where the pipette 110 is not inverted up and down, the upper end opening 114 faces upward. On the other hand, in the inverted state where the pipette 110 is inverted up and down, the upper end opening 114 faces downward. Note that the heparin is introduced into the accommodating portion 112 through the upper end opening 114 with the pipette 110 in the inverted state (inverted up and down) and the upper end opening 114 facing downward.
[0060] <Lower end opening 116> The pipette 110 has a lower end opening 116 at its lower part. The lower end opening 116 communicates with the accommodating part 112. The pipette 110 is connected to the chemical solution line 100 at the lower end opening 116. Through the chemical solution line 100, the priming solution is introduced from the lower end opening 116 into the accommodating part 112. Also, the heparin diluted by the priming solution is led out from the accommodating part 112 to the chemical solution line 100 through the lower end opening 116. In the normal upright state where the pipette 110 is not turned upside down, the lower end opening 116 faces downward. Note that the priming solution and the diluted heparin are introduced and led out in the normal upright state where the pipette 110 is not turned upside down, that is, in the state where the lower end opening 116 faces downward. Also, the heparin not diluted by the priming solution is led out in the normal upright state where the pipette 110 is not turned upside down, that is, in the state where the lower end opening 116 faces downward.
[0061] <<Other configurations of the chemical solution supply device 10A>> The chemical solution supply device 10A mainly includes the chemical solution line 100, the pipette 110, and also, the blood purification device 70 mainly includes the dialyzer 20 having a blood purification function, the blood circuit to which the arterial side blood circuit 30 and the venous side blood circuit 40 are connected, the blood pump 50, the dialysis device main body 60 to which the dialysate introduction line 62 and the dialysate discharge line 64 are connected, the control device 66, the chemical solution clamp means 120, the diaphragm pump 130, the liquid level adjustment pump 140, the liquid level detection device 150, the air detection device 160, and an example having these components is shown.
[0062] Not limited to this configuration, at least one of the chemical solution clamp means 120, the diaphragm pump 130, the liquid level adjustment pump 140, the liquid level detection device 150, and the air detection device 160 may be included in the chemical solution supply device 10A. For example, a control device (not shown) having a processor (processing device) or the like is provided in the chemical solution supply device 10A so that a control signal can be output from the control device or a detection signal can be input to the control device. Further, the control device of the chemical solution supply device 10A is connected to the control device 66 of the blood purification device 70 so as to be mutually communicable. Among the chemical solution clamp means 120, the diaphragm pump 130, the liquid level adjustment pump 140, the liquid level detection device 150, and the air detection device 160, they are appropriately divided and controlled between those controlled by the control device 66 of the blood purification device 70 and those controlled by the control device of the chemical solution supply device 10A.
[0063] Note that only the control device of the chemical solution supply device 10A may control all of the chemical solution clamp means 120, the diaphragm pump 130, the liquid level adjustment pump 140, the liquid level detection device 150, and the air detection device 160. The chemical solution clamp means 120, the diaphragm pump 130, and the liquid level adjustment pump 140 are controlled by a control signal output from the control device of the chemical solution supply device 10A, and a detection signal output from the liquid level detection device 150 and the air detection device 160 is input to the control device of the chemical solution supply device 10A.
[0064] <<Processing by Chemical Solution Supply Device 10A>> FIG. 2 is a schematic diagram showing a filling process in the chemical solution supply device 10A according to the first embodiment. FIG. 3 is a schematic diagram showing a dilution process in the chemical solution supply device 10A according to the first embodiment. FIG. 4 is a schematic diagram showing an administration preparation process in the chemical solution supply device 10A according to the first embodiment. As shown in FIGS. 2 to 4, the processing by the chemical solution supply device 10A includes a filling process, a dilution process, and an administration preparation process.
[0065] In FIGS. 2 to 4, the valves shown in white indicate the open state, and the valves shown in black indicate the closed state. Also, in FIGS. 2 to 4, the presence of heparin is indicated by diagonal lines, and the presence of the priming solution is indicated by horizontal lines. The leftward white arrow on the diaphragm pump 130 indicates that the diaphragm 131 has been pressed, and the rightward white arrow on the diaphragm pump 130 indicates that the diaphragm 131 has been suctioned.
[0066] <<Filling Step>> As shown in FIG. 2, the filling step is a step of introducing heparin from the vial into the pipette 110. By the filling step, heparin contained in a container such as a vial (such as the container at the time of delivery) can be introduced into the pipette 110. Heparin can be used regardless of the shape of the container at the time of delivery or the form of the container such as the opening of the container. It is possible to accommodate a wide variety of containers in which heparin is contained. Note that in the filling step, the blood pump 50 is stopped.
[0067] <Filling Step 1> FIG. 2(a) shows the first step of the filling step. At this point, both the chemical solution clamp means 120 and the arterial clamp means 36 are in the open state (shown in white).
[0068] First, place a vial containing heparin below the pipette 110. Next, invert the pipette 110 so that the upper end opening 114 is positioned downward (in an inverted state). The inversion of the pipette 110 may be manual or by a control signal from the control device 66. By providing a driving device such as a motor on the pipette 110, the pipette 110 can be inverted up and down by a control signal. Insert the upper end opening 114 positioned downward into the vial to communicate with the vial.
[0069] <Filling Step 2> FIG. 2(b) shows the second step of the filling step.
[0070] The processor of the control device 66 outputs a control signal to close the chemical liquid clamping means 120 (shown in black). The processor of the control device 66 outputs a control signal to drive the liquid level adjustment pump 140 to press the diaphragm 131 of the diaphragm pump 130.
[0071] <Filling step 3> Figure 2(c) shows the last step of the filling process.
[0072] The processor of the control device 66 outputs a control signal to stop the blood pump 50 and close the arterial clamping means 36 (black). The processor of the control device 66 outputs a control signal to open the chemical liquid clamping means 120 (white).
[0073] The processor of the control device 66 outputs a control signal to drive the liquid level adjustment pump 140 to suck the diaphragm 131 of the diaphragm pump 130. Thereby, the inside of the pipette 110 can be put into a negative pressure state. When the inside of the pipette 110 is in a negative pressure state, the heparin contained in the vial is sucked out from the vial and introduced into the pipette 110.
[0074] An amount of heparin corresponding to the difference between the deformation by pressing and the deformation by suction of the diaphragm 131 of the diaphragm pump 130 is introduced into the pipette 110. By operating the diaphragm 131 of the diaphragm pump 130 to deform at least once, a desired amount of heparin can be introduced from the vial into the pipette 110.
[0075] By the filling process shown in FIGS. 2(a) to 2(c), heparin can be introduced into the pipette 110 regardless of the form of the container such as the shape and the opening of the container storing the heparin.
[0076] After the filling process is completed, the pipette 110 is turned upside down (returned from the inverted state to the upright state), and the upper end opening 114 is positioned upward. Similar to the filling process, the inversion operation of the pipette 110 may be manual or by a control signal from the control device 66. By setting the pipette 110 in the upright state in advance, it is possible to smoothly transition to the dilution process and the administration preparation process described later.
[0077] <<Dilution Process>> As shown in FIG. 3, the dilution process is a process of diluting the heparin introduced into the pipette 110 with a priming solution by introducing the priming solution into the pipette 110. If there is no need to dilute the heparin, the dilution process can be omitted and the process can proceed to the administration preparation process described later.
[0078] <Dilution Process 1> FIG. 3(a) shows the first step of the dilution process.
[0079] The processor of the control device 66 outputs a control signal to make the chemical solution clamp means 120 in the closed state (black). The processor of the control device 66 outputs a control signal to drive the blood pump 50, thereby rotating the rotor (not shown) of the blood pump 50 in the forward direction to introduce the priming solution into the arterial side blood circuit 30. The forward rotation is the direction in which the liquid flows from the arterial side blood circuit 30 to the venous side blood circuit 40. The reverse rotation (counter rotation) is the direction in which the liquid flows from the venous side blood circuit 40 to the arterial side blood circuit 30. For example, a priming solution storage bag containing the priming solution is connected to the arterial side blood circuit 30 (not shown). By guiding the priming solution from the priming solution storage bag to the arterial side blood circuit 30 by the blood pump 50, the priming solution can be led out to the arterial side blood circuit 30. After leading out the desired amount of the priming solution to the arterial side blood circuit 30, the blood pump 50 is stopped.
[0080] <Dilution Process 2> FIG. 3(b) shows the second step of the dilution process.
[0081] The processor of the control device 66 outputs a control signal to maintain the chemical solution clamp means 120 in the closed state (black). The processor of the control device 66 outputs a control signal to drive the liquid level adjustment pump 140 to suck the diaphragm 131 of the diaphragm pump 130. Note that in the dilution step 2, the blood pump 50 is stopped.
[0082] <Dilution Step 3> Figure 3(c) shows the last step of the dilution process.
[0083] When the blood pump 50 is operating, the processor of the control device 66 outputs a control signal to stop the blood pump 50 and close the arterial clamp means 36. The processor of the control device 66 outputs a control signal to open the chemical solution clamp means 120 to the open state (white).
[0084] The processor of the control device 66 outputs a control signal to drive the liquid level adjustment pump 140 to press the diaphragm 131 of the diaphragm pump 130. Thereby, the inside of the arterial blood circuit 30 can be brought into a positive pressure state. When the inside of the arterial blood circuit 30 becomes a positive pressure state, the priming liquid introduced into the arterial blood circuit 30 is pushed out toward the pipette 110 and introduced into the pipette 110 through the chemical solution line 100.
[0085] An amount of priming liquid corresponding to the difference between the deformation due to the pressing and the deformation due to the suction of the diaphragm 131 of the diaphragm pump 130 is introduced into the pipette 110. By operating the diaphragm 131 of the diaphragm pump 130 at least once, a desired amount of priming liquid can be introduced from the arterial blood circuit 30 into the pipette 110.
[0086] By doing so, the heparin contained in the pipette 110 can be diluted with the priming liquid in the pipette 110. Hereinafter, the heparin diluted with the priming liquid is referred to as diluted heparin.
[0087] The liquid level detection device 150 detects the amount of diluted heparin stored in the pipette 110. The detection signal indicating the amount of diluted heparin is transmitted to the processor of the control device 66. The processor of the control device 66 can determine whether the desired amount of diluted heparin is stored in the pipette 110. The processor of the control device 66 can calculate the concentration of the diluted heparin.
[0088] <<Administration Preparation Step>> As shown in FIG. 4, the administration preparation step is a step of making undiluted heparin or diluted heparin in the pipette 110 administrable to the patient. In the administration preparation step, the blood pump 50 is stopped. When diluting heparin, the process proceeds from the dilution step to the administration preparation step. When there is no need to dilute heparin, the process immediately proceeds from the filling step to the administration preparation step.
[0089] <Administration Preparation Step 1> FIG. 4(a) shows the first step of the administration preparation step.
[0090] The processor of the control device 66 outputs a control signal to make the chemical solution clamp means 120 in the closed state (black). The processor of the control device 66 outputs a control signal to drive the liquid level adjustment pump 140 to press the diaphragm 131 of the diaphragm pump 130.
[0091] <Administration Preparation Step 2> FIG. 4(b) shows the last step of the administration preparation step.
[0092] When the blood pump is operating, the processor of the control device 66 outputs a control signal to stop the blood pump and close the arterial clamp means 36 (black). The processor of the control device 66 outputs a control signal to open the chemical solution clamp means 120 (white). The processor of the control device 66 outputs a control signal to drive the liquid level adjustment pump 140 to suck the diaphragm 131 of the diaphragm pump 130. Thereby, the inside of the pipette 110 and the arterial side blood circuit 30 can be put into a negative pressure state. Since the inside of the pipette 110 and the arterial side blood circuit 30 are in a negative pressure state, the diluted heparin contained in the pipette 110 is sucked out from the pipette 110 and introduced into the arterial side blood circuit 30 through the chemical solution line 100.
[0093] An amount of diluted heparin corresponding to the difference between the deformation due to the pressing of the diaphragm 131 of the diaphragm pump 130 and the deformation due to the suction flows through the chemical solution line 100 and is led out to the arterial side blood circuit 30. By operating the diaphragm 131 of the diaphragm pump 130 at least once, a desired amount of diluted heparin can be led out to the arterial side blood circuit 30.
[0094] In this way, through the above-described filling process, dilution process, and administration preparation process, heparin can be diluted with the priming liquid in the pipette 110, and a desired amount of diluted heparin can be administered to the patient. If heparin is not diluted with the priming liquid, a desired amount of undiluted heparin can be administered to the patient through the above-described filling process and administration preparation process.
[0095] <<Chemical Solution Supply Device 10A, Filling Process, Dilution Process, Administration Preparation Process According to the First Embodiment>> According to the chemical solution supply device 10A according to the first embodiment, heparin can be introduced into the pipette 110, a priming solution can be introduced into the pipette 110, and diluted heparin can be led out to the arterial blood circuit 30 by using the diaphragm pump 130 and the liquid level adjustment pump 140 provided in the blood circuit. In the filling process, the dilution process, and the administration preparation process, the diaphragm pump 130 and the liquid level adjustment pump 140 can be effectively utilized.
[0096] Since the diaphragm pump 130, the liquid level adjustment pump 140, etc. can be controlled by the control device 66 of the dialysis device main body 60, the dilution operation and administration preparation operation of heparin can be automated, the reproducibility of the dilution concentration with the priming solution, etc. can be increased, and it can be stably executed. In addition, by automation, the operation can be simplified and the burden on the user can be reduced. Furthermore, the filling process, the dilution process, the administration preparation process, and the filling process and the administration preparation process can be continuously executed.
[0097] Also, the pipette 110 has an extension part 113 that is thinner than the accommodation part 112. For this reason, it is easy to insert and extract the extension part 113 into and from the opening of a container such as a vial in which heparin is accommodated. In this way, it is less affected by the shape and size of the container and the opening, and heparin can be introduced into the pipette 110. The user can use the desired heparin. The heparin accommodated in the container can be used for multiple treatments. Since it is not necessary to administer heparin using a syringe, the treatment cost can be reduced.
[0098] The pipette 110 can be used not only for the introduction and storage of heparin, but also for the introduction and storage of the priming solution and the dilution of heparin. By effectively using the pipette 110, the number of members can be reduced. Also, by introducing the priming solution into the pipette 110, at the same time, the heparin in the pipette 110 can be diluted, and the dilution process can be simplified.
[0099] By using the flexible drug solution line 100, the pipette 110 and the like can be placed at a position separated from the blood circuit. This increases the degree of freedom in placing the pipette 110 and the like. The pipette 110 and the like can be placed so as not to interfere with other devices, and this increases the ease of use for the user.
[0100] The drug solution line 100 is shared for both the dilution process in which the priming solution is introduced from the arterial blood circuit 30 to the pipette 110, and the administration preparation process in which the diluted heparin is led from the pipette 110 to the arterial blood circuit 30, thereby reducing the number of components and simplifying the configuration.
[0101] <<<<Second embodiment>>>> FIG. 5 is a schematic diagram showing the filling process in the drug solution supplying device 10B according to the second embodiment. In the second embodiment, the drug solution supplying device 10B is also connected to the blood purification device 70 and applied to a hemodialysis device. In the second embodiment, the blood purification device 70 has a similar configuration to that of the first embodiment, except that it does not have the diaphragm pump 130 and the liquid level adjustment pump 140. In the second embodiment, the same reference numerals are used for the same configuration as in the first embodiment. In FIG. 5, the dialysis device main body 60 and the control device 66 are omitted.
[0102] <<<Configuration of blood purification device 70>>> The blood purification apparatus 70 of the second embodiment mainly includes: A dialyzer 20 having a blood purification function; A blood circuit in which an arterial blood circuit 30 and a venous blood circuit 40 are connected, A blood pump 50; A dialysis device main body 60 (not shown) to which a dialysis fluid inlet line 62 and a dialysis fluid outlet line 64 are connected, A control device 66 (not shown); A chemical solution clamping means 120; A liquid level detection device 150; A drip sensor 220; It has. The blood purification device 70 of the second embodiment has a drip sensor 220 and is different from the blood purification device 70 of the first embodiment in that it does not have a diaphragm pump 130 and a liquid level adjustment pump 140.
[0103] <<<Configuration of the chemical solution supply device 10B>>> The chemical solution supply device 10B can be provided outside the blood circuit and can be used with fewer modifications to the conventional blood circuit.
[0104] The chemical solution supply device 10B mainly, as shown in FIG. 5, a chemical solution line 200, a pipette 110, a dropping chamber 210, and has. The pipette 110 has the same configuration as that of the first embodiment and functions in the same manner.
[0105] <<Chemical solution line 200>> The chemical solution line 200 is connected to the blood circuit. Liquid can flow between the chemical solution line 200 and the blood circuit. The liquid is, for example, a priming liquid, diluted heparin, etc., but is not limited thereto. For example, the chemical solution line 200 is connected to and communicates with the arterial side blood circuit 30. The chemical solution line 200 is preferably composed of a flexible tube or the like. The pipette 110 can be arranged at a position separated from the arterial side blood circuit 30.
[0106] The chemical solution line 200 is connected to the arterial side blood circuit 30 at the connection part 280. The chemical solution line 200 is preferably detachably connected at the connection part 280. The chemical solution line 200 can be used as a disposable instrument in the same manner as the chemical solution line 100.
[0107] <Dropping chamber 210> The dropping chamber 210 separates the continuously flowing liquid into independent droplets and drops them by the action of gravity. The dropping chamber 210 is a member used in so-called drip infusion. Specifically, the dropping chamber 210 drops undiluted heparin or diluted heparin in the form of droplets. Details will be described later.
[0108] <Drip sensor 220> The drip sensor 220 detects the number of droplets dropped in the dropping chamber 210 (hereinafter referred to as the dropping number) and outputs a detection signal indicating the dropping number to the dialysis device. The control device 66 of the dialysis device main body 60 can execute processing based on the dropping number. Note that the control device 66 of the dialysis device main body 60 has the same configuration as that in the first embodiment and functions in the same manner. The control device 66 outputs a control signal for controlling various control devices, and a detection signal indicating the result detected by various detection devices is input to the control device 66.
[0109] In the second embodiment, the drip sensor 220 is detachably provided on the dropping chamber 210, but is not limited thereto. The drip sensor 220 may be configured to be integrated with the dropping chamber 210. The drip sensor 220 only needs to be able to detect the dropping number in the dropping chamber 210 and output a detection signal.
[0110] <<Other configurations of the chemical solution supply device 10B>> The blood purification device 70 of the second embodiment mainly includes a dialyzer 20 having a blood purification function, a blood circuit to which an arterial side blood circuit 30 and a venous side blood circuit 40 are connected, a blood pump 50, a dialysis device main body 60 to which a dialysis fluid introduction line 62 and a dialysis fluid discharge line 64 are connected, a control device 66, chemical solution clamp means 120, a liquid level detection device 150, a drip sensor 220, and has. The chemical solution supply device 10B mainly includes a chemical solution line 200, Pipette 110 and, Drop chamber 210, and An example having was shown.
[0111] Not limited to this configuration, at least one of the chemical solution clamp means 120, the liquid level detection device 150, and the drip sensor 220 may be provided in the chemical solution supply device 10B. For example, a control device (not shown) having a processor (processing device) or the like is provided in the chemical solution supply device 10B so that a control signal can be output from the control device or a detection signal can be input to the control device. Further, the control device of the chemical solution supply device 10B is connected to the control device 66 of the blood purification device 70 so as to be mutually communicable. Among the chemical solution clamp means 120, the liquid level detection device 150, and the drip sensor 220, they are appropriately divided and controlled between those controlled by the control device 66 of the blood purification device 70 and those controlled by the control device of the chemical solution supply device 10B.
[0112] Note that only the control device of the chemical solution supply device 10B may control all of the chemical solution clamp means 120, the liquid level detection device 150, and the drip sensor 220. The chemical solution clamp means 120 is controlled by a control signal output from the control device of the chemical solution supply device 10B, and detection signals output from the liquid level detection device 150 and the drip sensor 220 are input to the control device of the chemical solution supply device 10B.
[0113] <<Processing by Chemical Solution Supply Device 10B>> The processing by the chemical solution supply device 10B also includes a filling step, a dilution step, and an administration preparation step when diluting heparin with a priming solution. When not diluting heparin with a priming solution, the processing by the chemical solution supply device 10B includes a filling step and an administration preparation step. Note that FIG. 5 shows the dilution step (a) and the administration preparation step (b).
[0114] In FIG. 5, the valves shown in white indicate an open state, and the valves shown in black indicate a closed state. Also, in FIG. 5, the presence of heparin is indicated by diagonal lines, and the presence of the priming solution is indicated by horizontal lines.
[0115] <<Filling Process>> In the second embodiment, different from the first embodiment, heparin is introduced into the pipette 110 by the operation (manual) of the operator (see Fig. 2).
[0116] <<Dilution Process>> As shown in Fig. 5(a), the dilution process is a process of diluting the heparin introduced into the pipette 110 with the priming solution in the pipette 110 by introducing the priming solution into the pipette 110. If it is not necessary to dilute the heparin, the dilution process may be omitted and the administration preparation process described later may be immediately entered.
[0117] In the second embodiment, different from the first embodiment, the priming solution is introduced from the arterial side blood circuit 30 into the pipette 110 by rotating the blood pump 50 in the reverse direction. The blood pump 50 can be rotated in the reverse direction by a control signal from the control device 66. The liquid level detection device 150 can determine whether the amount of the priming solution in the pipette 110 has reached the required amount.
[0118] The dropping chamber 210 is arranged by being turned upside down. The upside-down of the dropping chamber 210 may be manual or by a control signal of the control device 66. By providing a driving device (not shown) such as a motor in the dropping chamber 210, the pipette 110 can be turned upside down by a control signal output from the control device 66.
[0119] The up-and-down inversion operation of the dropping chamber 210 may be manual or may use a driving device (not shown) such as a motor. The control device 66 of the blood purification device 70 outputs a control signal for causing the dropping chamber 210 to be inverted up and down to a driving device such as a motor. When the control device 66 of the blood purification device 70 outputs an upright command signal, the dropping chamber 210 is brought into an upright state by a driving device such as a motor. By outputting the upright command signal, the control device 66 can determine that the state of the dropping chamber 210 is the upright state. When the control device 66 of the blood purification device 70 outputs an inverted command signal, the dropping chamber 210 is brought into an inverted state by a driving device such as a motor. By outputting the inverted command signal, the control device 66 can determine that the state of the dropping chamber 210 is the inverted state.
[0120] Further, a sensor (not shown) for detecting whether the dropping chamber 210 is in either an upright state or an inverted state may be provided. The sensor may be an optical type, a mechanical type, or another detection method, as long as it can detect the upright state or the inverted state of the dropping chamber 210 and output a signal indicating the detection result. The control device 66 of the blood purification device 70 can acquire the state of the dropping chamber 210 by receiving the signal indicating the detection result emitted from the sensor. Even when a malfunction occurs in a driving device such as a motor, the state of the dropping chamber 210 can be accurately acquired.
[0121] Furthermore, when the operator manually turns the dropping chamber 210 upside down, after the operation of turning it upside down is completed, the operator operates the touch panel. For example, when the operator sets the dropping chamber 210 to the upright state, the operator inputs information indicating that it has been set to the upright state from the touch panel. By this operation, the touch panel outputs a signal indicating the upright state to the control device. Thereby, the control device 66 can determine that the state of the dropping chamber 210 is the upright state. On the other hand, when the operator sets the dropping chamber 210 to the inverted state, the operator inputs information indicating that it has been set to the inverted state from the touch panel. By this operation, the touch panel outputs a signal indicating the inverted state to the control device. Thereby, the control device 66 can determine that the state of the dropping chamber 210 is the inverted state.
[0122] Note that the pipette 110 may be arranged so as to always be positioned above the dropping chamber 210 in any case, whether the dropping chamber 210 is in the upright state or the inverted state after being turned upside down.
[0123] When the blood pump 50 is operating, the processor of the control device 66 outputs a control signal to stop the blood pump 50 and to set the arterial clamp means 36 to the closed state (black). The processor of the control device 66 outputs a control signal to set the chemical solution clamp means 120 to the open state (white).
[0124] The processor of the control device 66 outputs a control signal to drive the blood pump 50. By driving the blood pump 50, the priming liquid introduced into the arterial side blood circuit 30 is pushed out, flows through the chemical solution line 200, and is introduced into the pipette 110 via the chemical solution clamp means 120 and the dropping chamber 210. In this way, the priming liquid can be introduced into the pipette 110.
[0125] An amount of priming solution corresponding to the amount for driving the blood pump 50 is introduced into the pipette 110. By doing so, the heparin introduced into the pipette 110 can be diluted with the priming solution within the pipette 110. Also in the second embodiment, similar to the first embodiment, the heparin diluted with the priming solution is referred to as diluted heparin.
[0126] The liquid level detection device 150 detects the amount of diluted heparin stored in the pipette 110. The detection signal indicating the amount of diluted heparin is transmitted to the processor of the control device 66. The processor of the control device 66 can determine whether the desired amount of undiluted 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.
[0127] <<Administration Preparation Step>> The administration preparation step is a step of making the undiluted heparin or diluted heparin in the pipette 110 administrable to the patient, as shown in FIG. 5(b).
[0128] The dropping chamber 210 is turned upside down and returned to its original state. The upside-down rotation of the dropping chamber 210 may be manual or by a control signal from the control device 66.
[0129] The processor of the control device 66 outputs a control signal to drive the blood pump 50. By rotating the rotor (not shown) of the blood pump 50 in the forward direction, the diluted heparin corresponding to the amount by which the blood pump 50 is driven flows through the chemical solution line 200 and is led out to the arterial side blood circuit 30.
[0130] The drip sensor 220 detects droplet - shaped heparin every time undiluted heparin or diluted heparin is dripped in the drip chamber 210. The drip sensor 220 outputs a detection signal indicating that dripping has occurred to the control device 66. By receiving the detection signal, the control device 66 can count the number of drips of undiluted heparin or diluted heparin and calculate the total amount of undiluted heparin or diluted heparin administered. The control device 66 executes processing based on the total amount of undiluted heparin or diluted heparin. Note that the volume of one droplet of undiluted heparin or diluted heparin has been measured in advance and stored in the RAM of the control device 66 or the like.
[0131] <<Drug solution supply device 10B, filling process, dilution process, administration preparation process according to the second embodiment>> According to the drug solution supply device 10B according to the second embodiment, using the blood pump 50 provided in the blood circuit, the priming solution can be introduced into the pipette 110, or the diluted heparin can be led out to the arterial - side blood circuit 30. In the dilution process and the administration preparation process, the blood pump 50 can be effectively utilized.
[0132] According to the drug solution supply device 10B according to the second embodiment, without using the diaphragm pump 130 or the liquid - level adjustment pump 140 of the first embodiment, heparin can be diluted in the pipette 110 with a simple configuration, and undiluted heparin or diluted heparin can be administered. The dilution process and the administration preparation process can be executed without being restricted by the configuration of the blood circuit.
[0133] According to the medicinal liquid supplying device 10B of the second embodiment, the undiluted heparin or the diluted heparin can be measured in the administration preparation step using the drip chamber 210 and the drip sensor 220. If it can be linked to the dialysis device main body 60, it can be configured by utilizing components used at the site of dialysis treatment. That is, at the site of dialysis treatment, devices, parts, components, etc. are used in which 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 based on the number of drips. By effectively utilizing these devices, parts, components, etc., the medicinal liquid supplying device 10B of the second embodiment can be configured.
[0134] The pipette 110 can be used not only for introducing and storing heparin, but also for introducing and storing a priming liquid and diluting heparin, making it possible to effectively use the pipette 110 and reducing the number of components. Also, by introducing a priming liquid into the pipette 110, the heparin in the pipette 110 can be simultaneously diluted, simplifying the dilution process.
[0135] By using the flexible drug solution line 200, the pipette 110 and the like can be placed at a position separated from the blood circuit. This increases the degree of freedom in placing the pipette 110 and the like. The pipette 110 and the like can be placed so as not to interfere with other devices, and this increases the ease of use for the user.
[0136] The drug solution line 200 is shared by both the dilution process in which the priming solution is introduced from the arterial blood circuit 30 to the pipette 110, and the administration preparation process in which the diluted heparin is led from the pipette 110 to the arterial blood circuit 30, thereby reducing the number of components and simplifying the configuration.
[0137] <<<<Third embodiment>>>> FIG. 6 is a schematic diagram showing the configuration of the chemical solution supply device 10C according to the third embodiment. The chemical solution supply device 10C according to the third embodiment is connected to the blood purification device 70 and applied to a hemodialysis device, similar to the chemical solution supply device 10A according to the first embodiment. In the third embodiment as well, the same components as those in the first embodiment are denoted by the same reference numerals.
[0138] In the third embodiment, the blood purification device 70 mainly includes a dialyzer 20 having a blood purification function, a blood circuit to which an arterial side blood circuit 30 and a venous side blood circuit 40 are connected, a blood pump 50, a dialysis device main body 60 (not shown) to which a dialysis fluid introduction line 62 and a dialysis fluid discharge line 64 are connected, a control device 66 (not shown), a diaphragm pump 330, a liquid level adjustment pump 340, a solenoid valve 370, an extension part 313, a liquid level detection device 150, chemical solution clamp means 320, and has. In FIG. 6, the dialysis device main body 60 and the control device 66 are shown omitted. The control device 66 of the dialysis device main body 60 has the same configuration as that in the first embodiment and the second embodiment, and functions in the same manner. The control device 66 outputs a control signal for controlling various control devices, and a detection signal indicating the result detected by various detection devices is input to the control device 66.
[0139] <Diaphragm pump 330> The diaphragm pump 330 has a deformable diaphragm 331. The diaphragm pump 330 controls the flow of liquid by deforming the diaphragm 331. The diaphragm 331 of the diaphragm pump 330 is driven by a liquid level adjustment pump 340. The diaphragm pump 330 presses or sucks the diaphragm 331 by the liquid level adjustment pump 340. By deforming the diaphragm 331 by pressing or sucking the diaphragm 331 and generating a negative pressure in the arterial side blood circuit 30 or the venous side blood circuit 40, the flow of liquid in the arterial side blood circuit 30 and the venous side blood circuit 40 is controlled. The diaphragm pump 330 can repeat pressing and sucking by the liquid level adjustment pump 340.
[0140] Note that 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.
[0141] <Liquid level adjustment pump 340> The liquid level adjustment pump 340 deforms the diaphragm 331 of the diaphragm pump 330. The liquid level adjustment pump 340 presses or sucks the diaphragm 331 of the diaphragm pump 330.
[0142] The liquid level adjustment pump 340 has a driving device (not shown) such as a solenoid or a motor. The liquid level adjustment pump 340 is driven by a control signal output from the control device 66 to drive the driving device to press or suck.
[0143] <Solenoid valve 370> The solenoid valve 370 is actuated by a solenoid (not shown). The control device 66 outputs a control signal for controlling the solenoid. The solenoid is controlled by the control signal output from the control device 66, and the solenoid valve 370 is brought into an open state or a closed state. When the solenoid valve 370 is in the open state (shown in white), the pipette 310 communicates with the outside, and in response to the drive of the diaphragm pump 330, the air in the pipette 310 can be discharged to the outside. When the solenoid valve 370 is in the closed state (shown in black), the pipette 310 does not communicate with the outside, and even if the diaphragm pump 330 is driven, air cannot flow between the pipette 310 and the outside.
[0144] <Extension portion 313> The extension portion 313 has a long and substantially cylindrical shape. The extension portion 313 extends in a direction away from the housing portion 312 at the upper part of the housing portion 312. The extension portion 313 has a smaller diameter than the housing portion 312. The extension portion 313 is arranged concentrically with the housing portion 312. That is, the extension portion 313 is arranged so that the central axis of the extension portion 313 coincides with the central axis of the housing portion 312. The extension portion 313 communicates with the outside.
[0145] The diaphragm pump 330 and the solenoid valve 370 are connected to the extension portion 313. By controlling the diaphragm pump 330 and the solenoid valve 370, the air in the housing portion 312 can be discharged to the outside, and heparin or a priming solution can be introduced into the pipette 310. Details will be described later.
[0146] <<<Configuration of the chemical solution supply device 10C>>> The chemical solution supply device 10C can be provided outside the blood circuit and can be used with fewer changes to the conventional blood circuit.
[0147] The chemical solution supply device 10C mainly includes, as shown in FIG. 6, a chemical solution line 300, a pipette 310, and has.
[0148] <<Drug solution line 300>> The drug solution line 300 is connected to the blood circuit. Liquid can flow between the drug solution line 300 and the blood circuit. The liquid can be, but is not limited to, a priming solution or diluted heparin. For example, the drug solution line 300 is connected to and communicates with the arterial side blood circuit 30. The drug solution line 300 is preferably composed of a flexible tube or the like. The pipette 310 can be disposed at a position separated from the arterial side blood circuit 30.
[0149] The drug solution line 300 is connected to the arterial side blood circuit 30 at the connection part 380. The drug solution line 300 is preferably detachably connected at the connection part 380. Similar to the drug solution lines 100 and 200, the drug solution line 300 can be used as a disposable instrument.
[0150] <<Pipette 310>> Similar to the first embodiment and the second embodiment, heparin and a priming solution are introduced into the pipette 310. Also in the third embodiment, in the pipette 310, heparin is diluted by the priming solution.
[0151] The pipette 310 has an overall elongated shape. The pipette 310 is arranged such that its longitudinal direction is along the vertical direction. Different from the first embodiment, the pipette 310 does not need to be inverted up and down.
[0152] The pipette 310 mainly has a housing part 312, an upper end opening part 314, a first lower end opening part 316, and a second lower end opening part 318.
[0153] <Housing part 312> The housing part 312 has an elongated substantially cylindrical shape. Heparin and a priming solution are introduced into the housing part 312. In the housing part 312, heparin is diluted by the priming solution. Also, when the priming solution is not introduced into the housing part 312, in the housing part 312, heparin is not diluted by the priming solution and is simply in a state of being contained.
[0154] <Upper end opening 314> The pipette 310 has an upper end opening 314 at the upper part. The upper end opening 314 is connected to the extending part 313. The extending part 313 communicates with the outside, and air can be discharged from the accommodating part 312 to the outside through the upper end opening 314 and the extending part 313.
[0155] <Extending part 315> The extending part 315 has a long and substantially cylindrical shape. The extending part 315 extends in a direction (downward direction) away from the accommodating part 312 at the lower part of the accommodating part 312. The extending part 315 has a diameter smaller than that of the accommodating part 312. By making the extending part 315 thinner than the accommodating part 312, the extending part 315 can be inserted into and removed from the openings of various containers. Heparin contained in containers having various shapes and sizes can be introduced into the accommodating part 312. In particular, the extending part 315 is preferably formed to become thinner (in a tapered shape) as it separates from the accommodating part 312. It can be made easier to further insert and remove the extending part 315 into and from the openings of various containers.
[0156] <First lower end opening 316> The extending part 315 has a first lower end opening 316 at the lower end part (the part most separated from the accommodating part 312). The first lower end opening 316 communicates with the accommodating part 312 and the extending part 315. The first lower end opening 316 can be connected to a vial (see FIG. 7). Heparin stored in the vial is introduced into the accommodating part 312 through the first lower end opening 316 and the extending part 315.
[0157] <Second lower end opening 318> The pipette 310 has a second lower end opening 318 at the lower part. The second lower end opening 318 communicates with the accommodating part 312. The pipette 310 is connected to the chemical solution line 300 at the second lower end opening 318. Through the chemical solution line 300, the priming liquid is introduced into the accommodating part 312 from the second lower end opening 318. Also, the heparin diluted by the priming liquid is led out from the accommodating part 312 to the chemical solution line 300 through the second lower end opening 318. Further, when the heparin is not diluted with the priming liquid, the priming liquid is not introduced into the accommodating part 312, and the undiluted heparin is led out from the accommodating part 312 to the chemical solution line 300 through the second lower end opening 318.
[0158] <Chemical solution clamp means 320> The chemical solution clamp means 320 is provided on the chemical solution line 300. The chemical solution clamp means 320 can be in either an open state or a closed state. When the chemical solution clamp means 320 is in the open state, the liquid can flow in the chemical solution line 300. When the chemical solution clamp means 320 is in the closed state, the liquid cannot flow in the chemical solution line 300.
[0159] The chemical solution clamp means 320 has a driving device (not shown) such as a solenoid or a motor. The chemical solution clamp means 320 is driven by a control signal output from the control device 66, and becomes either an open state or a closed state.
[0160] <<Other configurations of the chemical solution supply device 10C>> In the third embodiment, the blood purification device 70 mainly includes a dialyzer 20 having a blood purification function, a blood circuit to which an arterial side blood circuit 30 and a venous side blood circuit 40 are connected, a blood pump 50, a dialysis device main body 60 to which a dialysate introduction line 62 and a dialysate discharge line 64 are connected, a control device 66, a diaphragm pump 330, a liquid level adjustment pump 340, a solenoid valve 370, the extending portion 313, the liquid level detection device 150, and The chemical solution supply device 10C mainly has the chemical solution line 300, the pipette 310, is shown as an example.
[0161] The present invention is not limited to this configuration, and at least one of the diaphragm pump 330, the liquid level adjustment pump 340, the solenoid valve 370, the extending portion 313, the liquid level detection device 150, and the chemical solution clamping means 320 may be included in the chemical solution supply device 10C. For example, a control device (not shown) having a processor (processing device) or the like is provided in the chemical solution supply device 10C so that a control signal can be output from the control device or a detection signal can be input to the control device. Further, the control device of the chemical solution supply device 10C is connected to the control device 66 of the blood purification device 70 so as to be communicable with each other. Among the diaphragm pump 330, the liquid level adjustment pump 340, the solenoid valve 370, and the chemical solution clamping means 320, those controlled by the control device 66 of the blood purification device 70 and those controlled by the control device of the chemical solution supply device 10C are appropriately divided and controlled.
[0162] Note that only the control device of the chemical solution supply device 10C may control all of the diaphragm pump 330, the liquid level adjustment pump 340, the solenoid valve 370, and the chemical solution clamping means 320. The diaphragm pump 330, the liquid level adjustment pump 340, the solenoid valve 370, and the chemical solution clamping means 320 are controlled by a control signal output from the control device of the chemical solution supply device 10C, and a detection signal output from the liquid level detection device 150 is input to the control device of the chemical solution supply device 10C.
[0163] <<Processing by the Chemical Solution Supply Device 10C>> FIG. 7 is a schematic diagram showing a filling step in the chemical solution supply device 10C according to the third embodiment. FIG. 8 is a schematic diagram showing a dilution step in the chemical solution supply device 10C according to the third embodiment. FIG. 9 is a schematic diagram showing an administration preparation step in the chemical solution supply device 10C according to the third embodiment. As shown in FIGS. 7 to 9, the processing by the chemical solution supply device 10C includes a filling step, a dilution step, and an administration preparation step when heparin is diluted with a priming solution. Further, when heparin is not diluted with a priming solution, the processing by the chemical solution supply device 10C includes a filling step and an administration preparation step.
[0164] Also in FIGS. 7 to 9, the valves shown in white indicate an open state, and the valves shown in black indicate a closed state. Further, in FIGS. 7 to 9, the presence of heparin is indicated by diagonal lines, and the presence of the priming solution is indicated by horizontal lines. The leftward white arrow on the diaphragm pump 330 indicates that the diaphragm 331 has been pressed, and the rightward white arrow on the diaphragm pump 330 indicates that the diaphragm 331 has been suctioned.
[0165] <<Filling Step>> As shown in FIG. 7, the filling step is a step of introducing heparin from the vial into the pipette 310. By the filling step, heparin contained in a container such as a vial (container at the time of delivery, etc.) can be introduced into the pipette 310. Heparin can be used regardless of the shape of the container at the time of delivery or the form of the container such as the opening of the container. It is possible to correspond to a variety of containers in which heparin is stored. Note that in the filling step, the blood pump 50 is stopped.
[0166] <Filling Step 1> Figure 7(a) shows the first step of the filling process. At this point, both the chemical solution clamp means 320 and the solenoid valve 370 and the arterial clamp means 36 are in the open state (white). Note that in the chemical solution supply device 10C, the arterial clamp means 36 is in the open state (white) not only in the filling process but also in the dilution process and the administration preparation process. The chemical solution supply device 10C may not have the arterial clamp means 36. When the chemical solution supply device 10C does not have the arterial clamp means 36, the control for the arterial clamp means 36 can be omitted. Also, as shown in FIGS. 7 to 9, when the chemical solution supply device 10C uses a system having the arterial clamp means 36, control may be performed to keep the arterial clamp means 36 in the open state at all times.
[0167] First, place a vial containing heparin below the pipette 310. Next, insert the first lower end opening 316 of the pipette 310 into the vial to communicate with the vial.
[0168] <Filling process 2> Figure 7(b) shows the second step of the filling process.
[0169] The processor of the control device 66 outputs a control signal to close the chemical solution clamp means 320 (black). The processor of the control device 66 outputs a control signal to open the solenoid valve 370 (white). The processor of the control device 66 outputs a control signal to drive the liquid level adjustment pump 140 to press the diaphragm 331 of the diaphragm pump 330.
[0170] <Filling process 3> Figure 7(c) shows the last step of the filling process.
[0171] The processor of the control device 66 outputs a control signal to close the chemical liquid clamp means 320 (black). The processor of the control device 66 outputs a control signal to close the solenoid valve 370 (black). The processor of the control device 66 outputs a control signal to drive the liquid level adjustment pump 140 to suck the diaphragm 331 of the diaphragm pump 330. Thereby, the inside of the pipette 310 can be brought into a negative pressure state. When the inside of the pipette 310 is in a negative pressure state, the heparin contained in the vial is sucked out from the vial and introduced into the pipette 310.
[0172] An amount of heparin corresponding to the difference between the deformation due to the pressing of the diaphragm 331 of the diaphragm pump 330 and the deformation due to the suction is introduced into the pipette 310. By operating the diaphragm 331 of the diaphragm pump 330 to deform at least once, a desired amount of heparin can be introduced from the vial into the pipette 310.
[0173] By the filling process shown in FIGS. 7(a) to 7(c), heparin can be introduced into the pipette 110 regardless of the form of the container such as the shape and the opening of the container containing heparin.
[0174] <<Dilution process>> As shown in FIG. 8, the dilution process is a process of diluting the heparin introduced into the pipette 310 with the priming liquid in the pipette 310 by introducing the priming liquid into the pipette 310. In the dilution process, the blood pump 50 is stopped. If there is no need to dilute the heparin, the dilution process can be omitted and the administration preparation process described later can be entered.
[0175] <Dilution process 1> FIG. 8(a) shows the first step of the dilution process.
[0176] The processor of the control device 66 outputs a control signal to make the chemical liquid clamping means 320 in a closed state (black). The processor of the control device 66 outputs a control signal to rotate the blood pump 50 forward to introduce the priming liquid into the arterial side blood circuit 30. For example, a priming liquid storage bag containing the priming liquid is connected to the arterial side blood circuit 30 (not shown). By guiding the priming liquid from the priming liquid storage bag to the arterial side blood circuit 30 by the blood pump 50, the priming liquid can be introduced into the arterial side blood circuit 30.
[0177] Remove the pipette 310 from the vial and seal the first lower end opening 316 of the pipette 310 with the clamp 319. By sealing, it is possible to prevent the heparin introduced into the pipette 310 from leaking out from the first lower end opening 316.
[0178] Note that a driving device such as a motor may be provided on the pipette 310, and the pipette 310 may be removed from the vial and the first lower end opening 316 of the pipette 310 may be clamped under the control of a control signal issued from the control device 66.
[0179] <Dilution step 2> Figure 8(b) shows the second step of the dilution step.
[0180] The processor of the control device 66 outputs a control signal to make the chemical liquid clamping means 320 in a closed state (black). The processor of the control device 66 outputs a control signal to make the solenoid valve 370 in an open state (white). The processor of the control device 66 outputs a control signal to drive the liquid level adjustment pump 140 to press the diaphragm 331 of the diaphragm pump 330.
[0181] <Dilution step 3> Figure 8(c) shows the last step of the dilution step.
[0182] The processor of the control device 66 outputs a control signal to open the chemical solution clamp means 320 (white). The processor of the control device 66 outputs a control signal to close the solenoid valve 370 (black). The processor of the control device 66 outputs a control signal to drive the liquid level adjustment pump 140 to suck the diaphragm 331 of the diaphragm pump 330. Thereby, the inside of the pipette 310 can be brought into a negative pressure state. Since the inside of the pipette 310 is in a negative pressure state, the priming liquid introduced into the arterial side blood circuit 30 is sucked out and introduced into the pipette 310 through the chemical solution line 300.
[0183] An amount of priming liquid corresponding to the difference between the deformation due to the pressing of the diaphragm 331 of the diaphragm pump 330 and the deformation due to the suction is introduced into the pipette 310. By operating the diaphragm 331 of the diaphragm pump 330 to deform at least once, a desired amount of priming liquid can be introduced from the arterial side blood circuit 30 into the pipette 310. By introducing the priming liquid into the pipette 310, the heparin contained in the pipette 310 can be diluted with the priming liquid inside the pipette 310.
[0184] Also in the third embodiment, the heparin diluted with the priming liquid is referred to as diluted heparin. Similar to the first embodiment, by providing the liquid level detection device 150 in the pipette 310, the processor of the control device 66 can determine whether a desired amount of undiluted heparin or diluted heparin is stored in the pipette 310. The processor of the control device 66 can calculate the concentration of heparin.
[0185] <<Administration preparation step>> As shown in FIG. 9, the administration preparation step is a step of making the undiluted heparin or diluted heparin in the pipette 310 administrable to the patient. When diluting heparin, the process proceeds from the dilution step to the administration preparation step. When there is no need to dilute heparin, the process immediately proceeds from the filling step to the administration preparation step.
[0186] <Administration preparation step 1> Figure 9(a) shows the first step of the administration preparation process. In the administration preparation process 1, the blood pump 50 is stopped.
[0187] The processor of the control device 66 outputs a control signal to close the chemical solution clamp means 320 (black). The processor of the control device 66 outputs a control signal to open the solenoid valve 370 (white). The processor of the control device 66 outputs a control signal to drive the liquid level adjustment pump 340 to suck the diaphragm 331 of the diaphragm pump 330.
[0188] <Administration Preparation Process 2> Figure 9(b) shows the last step of the administration preparation process.
[0189] When the blood pump is operating, the processor of the control device 66 outputs a control signal to stop the blood pump and open the chemical solution clamp means 320 (white). The processor of the control device 66 outputs a control signal to close the solenoid valve 370 (black). The processor of the control device 66 outputs a control signal to drive the liquid level adjustment pump 340 to press the diaphragm 331 of the diaphragm pump 330.
[0190] An amount of undiluted heparin or diluted heparin corresponding to the deformation of the diaphragm 331 of the diaphragm pump 330 is introduced into the arterial blood circuit 30. By operating the diaphragm 331 of the diaphragm pump 330 at least once, a desired amount of undiluted heparin or diluted heparin can be introduced into the arterial blood circuit 30. Thereby, the inside of the pipette 310 can be brought into a positive pressure state. When the inside of the pipette 310 is in a positive pressure state, the undiluted heparin or diluted heparin introduced into the pipette 310 is introduced into the arterial blood circuit 30 through the chemical solution line 300.
[0191] In this way, heparin can be diluted with a priming solution inside the pipette 310, and undiluted heparin or diluted heparin can be administered to the patient.
[0192] <<Drug solution supply device 10C, filling process, dilution process, administration preparation process according to the third embodiment>> According to the drug solution supply device 10C according to the third embodiment, the diaphragm pump 330 and the liquid level adjustment pump 340 can introduce heparin into the pipette 310, introduce the priming solution into the pipette 310, or lead out the diluted heparin to the arterial blood circuit 30. The diaphragm pump 330 and the liquid level adjustment pump 340 are provided separately from the configuration of the blood circuit. Therefore, the filling process, the dilution process, and the administration preparation process can be executed without being limited by the configuration of the blood circuit.
[0193] The diaphragm pump 330, the liquid level adjustment pump 340, etc. can be controlled by the control device 66 of the dialysis device main body 60, so the dilution operation and administration operation of heparin can be automated, the reproducibility of the dilution concentration with the priming solution, etc. can be increased, and it can be executed stably. Also, by automation, the operation can be simplified and the burden on the user can be reduced. Furthermore, the filling process, the dilution process, and the administration preparation process can be executed continuously.
[0194] Also, the pipette 310 has an extension portion 315 that extends in a direction away from the housing portion 312. For this reason, the pipette 310 can be connected to the vial without being inverted up and down, and heparin can be introduced into the housing portion 312. In this way, since the pipette 310 is not inverted up and down, the configuration can be simplified.
[0195] In addition, the pipette 310 has an extension part 315 that is thinner than the accommodating part 312. Therefore, it is easy to insert and extract the extension part 315 into and from the opening of a container such as a vial containing heparin. In this way, it is less affected by the shape and size of the container or the opening, and heparin can be introduced into the pipette 310. The user can utilize the desired heparin. The heparin contained in the container can be used for multiple treatments. Since there is no need to administer heparin using a syringe, the treatment cost can be reduced.
[0196] The pipette 310 can be used not only for the introduction and storage of heparin, but also for the introduction and storage of a priming solution and the dilution of heparin. By effectively using the pipette 310, the number of components can be reduced. In addition, by introducing a priming solution into the pipette 310, the heparin in the pipette 310 can be diluted simultaneously, and the dilution process can be simplified.
[0197] By using the flexible chemical solution line 300, the pipette 310 and the like can be arranged at a position separated from the blood circuit. The degree of freedom in arranging the pipette 310 and the like can be increased. The pipette 310 and the like can be arranged so as not to interfere with other devices, etc., and the workability of the user can be improved.
[0198] The chemical solution line 300 is shared in both the dilution process of introducing the priming solution from the arterial side blood circuit 30 into the pipette 310 and the administration preparation process of leading the diluted heparin from the pipette 310 to the arterial side blood circuit 30. Therefore, the number of components can be reduced and the configuration can be simplified.
[0199] <<<Modification Example>>> In the third embodiment described above, an example in which the blood purification device 70 includes a diaphragm pump 330, a liquid level adjustment pump 340, a solenoid valve 370, and an extension portion 313 was shown. However, the chemical solution supply device 10C may be configured to include a diaphragm pump 330 and an extension portion 313. The diaphragm pump 330 and the liquid level adjustment pump 340 can be controlled by a control device (not shown) of the chemical solution supply device 10C instead of the control device 66 of the blood purification device 70.
[0200] The control device of the chemical solution supply device 10C mainly includes a processor (such as a CPU (Central Processing Unit)), a ROM (Read Only Memory), a RAM (Random Access Memory), an I / O (Input / Output Interface), an I / F (Interface Device), an auxiliary storage device (such as an HDD (Hard Disk Drive) or an SSD (Solid State Drive)), an input operation device (such as a touch panel or a keyboard), etc. The ROM stores programs and constants for executing various processes such as control processes. The RAM temporarily stores values of variables used when the program is executed.
[0201] The control device of the chemical solution supply device 10C outputs various control signals and inputs various detection signals via the I / O. For example, the control device outputs control signals to the liquid level adjustment pump 340, the solenoid valve 370, etc.
[0202] <<<Overall Processing of Control Device 66>>> FIG. 11 is a flowchart showing the overall processing of the control device 66. As described above, in the chemical solution supply devices 10A to 10C, the filling process, the dilution process, and the administration preparation process are sequentially executed under the control of the control device 66. In particular, when there is no need to dilute heparin, the operator can skip the dilution process and shift from the filling process to the administration preparation process by operating the input unit (FIG. 10).
[0203] The processor of the control device 66 executes the filling process (step S111).
[0204] If heparin is diluted in step S113 (YES), the processor of the control device 66 executes the dilution process (step S115).
[0205] If heparin is not diluted in step S113 (NO), or after the dilution process is executed, the processor of the control device 66 executes the administration preparation process (step S117).
[0206] <<<<Scope of the Embodiment>>>> So far, the first to third embodiments have been described. However, the descriptions and drawings that form part of this disclosure should not be understood as limiting. Various embodiments and the like not described here are included.
[0207] In the examples described in the first to third embodiments, as an example of the anticoagulant, the case of using heparin (unfractionated heparin) was shown. However, it is not limited to unfractionated heparin, and low molecular weight heparin, argatroban, nafamostat mesilate, etc. can be used. It can be appropriately selected and used according to characteristics such as the process of action, half-life, and side effects.
[0208] <<<<Embodiments of the Invention>>>> <<First Aspect>> According to the first aspect of the chemical solution supply device, A chemical solution supply device that supplies a chemical solution to a blood circuit (for example, an arterial side blood circuit 30, a venous side blood circuit 40, etc.) of a blood purification device (for example, a dialysis device main body 60, etc.) that purifies blood, An anticoagulant (for example, heparin, etc.) contained in a container is introducible from the container, and a composition holding part (for example, a pipette 110, a pipette 310, etc.) that holds a composition containing at least the introduced anticoagulant, A connecting part (for example, chemical solution lines 100, 200, 300, etc.) that connects the composition holding part to the blood circuit and enables the composition to be led out from the composition holding part to the blood circuit, A chemical solution supply device comprising.
[0209] The chemical solution supply device is a device that supplies a chemical solution to a blood circuit. A blood purification device that purifies blood has a blood circuit. The chemical solution supply device includes a composition holding part and a connecting part.
[0210] An anticoagulant can be introduced into the composition holding part. That is, an anticoagulant can be introduced into the composition holding part. The anticoagulant is contained in a container. The container is one that is generally used for containing the anticoagulant. The container is one that is generally in circulation for containing the anticoagulant. The container has a shape, size, etc. for containing the anticoagulant.
[0211] "Can be introduced" means that not only the state where the anticoagulant is introduced into the composition holding part but also the preliminary and potential situations for introduction even when the anticoagulant is not introduced into the composition holding part are included in the chemical solution supply device according to the first aspect.
[0212] For example, even when the anticoagulant in the container and the composition holding part are separated, a situation where the composition holding part can necessarily come into contact with the anticoagulant in the container, etc. is applicable. Also, even when the anticoagulant in the container is in contact with the composition holding part, if the driving part such as a pump is not driven, the anticoagulant will not be introduced into the composition holding part. However, if the driving part is driven, the anticoagulant will be immediately introduced into the composition holding part. Such situations, etc. are also applicable.
[0213] Thus, "can be introduced" means including the preliminary and potential situations for the anticoagulant to be introduced from the container into the composition holding part.
[0214] The composition holding part holds a composition. The composition includes at least the anticoagulant introduced into the composition holding part. The composition may be only the anticoagulant or may include other components.
[0215] The composition holding part can have an anticoagulant introduced therein and can hold a composition containing at least the introduced anticoagulant.
[0216] The connecting part connects the composition holding part to the blood circuit. The composition holding part is connected to the blood circuit by the connecting part. The connecting part can lead the composition from the composition holding part to the blood circuit. That is, the composition held in the composition holding part can be led from the composition holding part to the blood circuit via the connecting part.
[0217] "Derivable" means that not only the state where the composition has been led into the blood circuit, but also the preliminary and potential situations for derivation, even when the composition has not been led into the blood circuit, are included in the chemical solution supply device according to the first aspect.
[0218] For example, even when the composition holding part is separated from the blood circuit, situations where the composition holding part can necessarily be connected to the blood circuit are applicable. Also, even when the composition holding part is connected to the blood circuit, if members such as pumps and valves are not in a derivable state, the composition will not be led into the blood circuit. However, if the members are in a derivable state, the composition will be immediately led into the blood circuit. Such situations are applicable.
[0219] Thus, "derivable" means including the preliminary and potential situations for leading the composition into the blood circuit.
[0220] Since an anticoagulant contained in a generally used or circulated container can be introduced into the composition holding part, it is possible to prevent replacement into another container or discarding of the anticoagulant. It is possible to prevent the work from becoming complicated or the anticoagulant from being wasted.
[0221] <<Second Aspect>> The second aspect is, in the first aspect, detecting the liquid level of the composition held in the composition holding part using a liquid level detection device (for example, liquid level detection device 150, etc.), and further includes.
[0222] Since the liquid level detection device detects the liquid level of the composition, the amount of the anticoagulant introduced into the composition holding part and the amount of the composition remaining in the composition holding part can be obtained, and the chemical liquid supply device can be appropriately controlled. Whether the blood purification device has the liquid level detection device or the chemical liquid supply device or other devices may have the liquid level detection device. It is sufficient that the blood purification device or the chemical liquid supply device or the like can be controlled based on the liquid level of the composition detected by the liquid level detection device.
[0223] <<Third Aspect>> The third aspect is in the first aspect or the second aspect, It is detected by an empty detection device (for example, the empty detection device 160, etc.) that the composition has become empty in the composition holding part. Further provided.
[0224] Since the empty detection device can detect that the composition is empty, it is possible to appropriately determine whether the anticoagulant may be introduced into the composition holding part, whether the derivation of the composition should be stopped, etc. Whether the blood purification device has the empty detection device or the chemical liquid supply device or other devices may have the empty detection device. It is sufficient that the blood purification device or the chemical liquid supply device or the like can be controlled based on the detection result detected by the empty detection device.
[0225] <<Fourth Aspect>> The fourth aspect is in any one of the first aspect to the third aspect, A diluent (for example, a priming solution, etc.) can be introduced into the composition holding part, The composition diluted with the introduced diluent can be held in the composition holding part.
[0226] Not only the anticoagulant but also the diluent can be introduced into the composition holding part. By introducing the diluent into the anticoagulant introduced into the composition holding part, the anticoagulant can be diluted in the composition holding part, and the diluted anticoagulant can be held in the composition holding part as the composition.
[0227] "Capable of being introduced" means that not only when the diluent is introduced into the composition holding part, but also when the diluent is not introduced into the composition holding part, the preparatory and potential situations for introduction are included in the chemical solution supply device according to the fourth aspect.
[0228] For example, even when the composition holding part is in a state separated from the blood circuit, a situation where the composition holding part can be inevitably connected to the blood circuit is applicable. Also, even when the composition holding part is connected to the blood circuit, if members such as a pump and a valve are not in an introduced state, the diluent will not be introduced into the composition holding part. However, if the members are in an introduced state, the diluent will be immediately introduced into the composition holding part. Such situations are applicable.
[0229] Thus, "capable of being introduced" means including the preparatory and potential situations for the diluent to be introduced from the blood circuit into the composition holding part.
[0230] The diluent can be introduced into the composition holding part from the blood circuit via, for example, a connecting part. The route for introducing the diluent is not limited to this, and any route that can introduce the diluent into the composition holding part may be used.
[0231] <<Fifth Aspect>> The fifth aspect is, in any one of the first to fourth aspects, a first communication part that communicates the container and the composition holding part, and enables the anticoagulant contained in the container to be introduced into the composition holding part (for example, the extending part 113, the first lower end opening 316, etc.), and a second communication part that communicates the composition holding part and the connecting part, and enables the composition held in the composition holding part to be led out to the connecting part (for example, the lower end opening 116, the second lower end opening 318, etc.), and further includes.
[0232] The chemical solution supply device according to the fifth aspect includes a first communication part and a second communication part.
[0233] The first communication part communicates the container with the composition holding part. The first communication part enables the introduction of the anticoagulant contained in the container into the composition holding part. The anticoagulant contained in the container can be introduced into the composition holding part via the first communication part.
[0234] Note that the meaning of "introducible" in the fifth aspect is the same as that of "introducible" in the first aspect.
[0235] The second communication part communicates the composition holding part with the connecting part. The second communication part enables the derivation of the composition held in the composition holding part to the connecting part. The composition held in the composition holding part can be derived to the connecting part via the second communication part.
[0236] Note that the meaning of "derivable" in the fifth aspect is the same as that of "derivable" in the first aspect.
[0237] By providing separately the path through which the anticoagulant flows and the path through which the composition or diluent flows with the composition holding part sandwiched therebetween, it is possible to keep the state such as the concentration and cleanliness of the anticoagulant contained in the container constant.
[0238] <<Sixth Aspect>> The sixth aspect is any one of the first aspect to the fifth aspect, wherein the second communication part has a diluent introduction state for introducing a diluent into the composition holding part and a composition derivation state for deriving the composition to the connecting part.
[0239] The second communication part can be shared for both the diluent introduction state and the composition derivation state. The diluent introduction state is a state in which a diluent is introduced into the composition holding part via the connecting part. The composition derivation state is a state in which the composition is derived to the connecting part via the connecting part. By sharing the second communication part, the configuration can be simplified.
[0240] <<Seventh Aspect>> The seventh aspect is the method according to any one of the first to sixth aspects, The blood circuit further includes a diaphragm pump (such as diaphragm pump 130) that controls the flow of liquid in the blood circuit by deformation of a diaphragm.
[0241] The flow of liquid in the blood circuit is controlled by using the diaphragm pump of the blood circuit, so that the diluent can be introduced into the composition holding part and the composition can be discharged into the connecting part without providing a separate drive device for controlling the flow of liquid. By sharing the diaphragm pump, the configuration of the drug solution supply device can be simplified.
[0242] <<Eighth aspect>> The eighth aspect is the method according to any one of the first to seventh aspects, The apparatus further includes a drip chamber (e.g., drip chamber 210) that separates the continuously flowing composition into separate droplets and drips them by the action of gravity; The composition dispensed from the dispense chamber is detected using a dispense sensor (such as, for example, dispense sensor 220).
[0243] Since the composition can be delivered from the composition holding section to the blood circuit using components that are regularly provided or regularly used in dialysis facilities, the drug solution supplying device can be easily and simply configured. The blood purification device may have a drip sensor, or the drug solution supplying device or another device may have a drip sensor. It is sufficient that the blood purification device or the drug solution supplying device can be controlled based on the detection result detected by the drip sensor.
[0244] <<Ninth Aspect>> A ninth aspect is the method according to any one of the first to eighth aspects, An extension (such as extension 313) spaced apart from the composition holding portion has a diaphragm pump (such as diaphragm pump 330) that controls the flow of air within the extension by deformation of a diaphragm.
[0245] "Fluidizable" means that not only the state in which air is flowing but also the preliminary and potential situations for flowing, even in the state where air is not flowing, are included in the chemical solution supply device according to the ninth aspect.
[0246] For example, if members such as a pump and a valve are not fluidizable, air does not flow in the extension part. However, if the members become fluidizable, air immediately flows in the extension part. Such situations are applicable.
[0247] Thus, "fluidizable" means including the preliminary and potential situations for air to flow in the extension part.
[0248] Even when the blood circuit does not have a driving device such as a diaphragm pump, by separately adding a diaphragm pump to the blood circuit, it can be configured to enable the introduction of an anticoagulant, the introduction of a diluent, and the derivation of a composition.
[0249] The extension part may or may not be included in the chemical solution supply device.
[0250] <<Tenth Aspect>> The tenth aspect is in any one of the first aspect to the ninth aspect, the first communication part has a protruding part having a long cylindrical shape (for example, the extension part 113, etc.), the protruding part is an opening that can be inserted into the through-hole of the container, and has an opening (for example, the upper end opening 114, etc.) provided at the tip most distant from the composition holding part.
[0251] The first communication part has a protruding part protruding from the composition holding part. The protruding part has an opening. The opening can be inserted into the through-hole of the container. The opening is provided at the tip most distant from the composition holding part.
[0252] The term "insertable" means that not only the state where the opening is inserted into the through-hole, but also the preliminary and potential situations for insertion are included in the chemical solution supply device according to the tenth aspect, even when the opening is not inserted into the through-hole.
[0253] For example, even when the opening is separated from the through-hole, a situation where the opening can necessarily be inserted into the through-hole is applicable.
[0254] Thus, "insertable" means including the preliminary and potential situations for the opening to be inserted into the through-hole.
[0255] By positioning the protruding portion inside the container through the through-hole, the anticoagulant contained in the container can be directly introduced into the composition holding portion through the opening, and the anticoagulant can be utilized without processing the container or transferring the anticoagulant to another container, simplifying the operation.
[0256] Note that it is preferable that the outer diameter of the protruding portion becomes thinner as it moves away from the composition holding portion. It can correspond to the sizes of various through-holes of the container, and the types of containers in which the first communication portion can be used can be increased.
[0257] <<Eleventh Aspect>> The eleventh aspect is, in any one of the first aspect to the tenth aspect, A chemical solution supply method for supplying a chemical solution to a blood circuit (for example, an arterial side blood circuit 30, a venous side blood circuit 40, etc.) of a blood purification device (for example, a dialysis device main body 60, etc.) that purifies blood, An anticoagulant introduction step of introducing an anticoagulant (for example, heparin, etc.) contained in a container into a composition holding portion (for example, a pipette 110, a pipette 310, etc.) from the container, A composition holding step of holding a composition containing at least the anticoagulant introduced into the composition holding portion in the composition holding portion, A composition derivation step of deriving the composition from the composition holding part to the blood circuit through a connection part (for example, chemical solution lines 100, 200, 300, etc.) that connects the composition holding part to the blood circuit; A chemical solution supply method including the above.
[0258] Since the anticoagulant contained in a generally used or distributed container can be introduced into the composition holding part, it is possible to prevent replacement into another container or disposal of the anticoagulant. It is possible to prevent the work from becoming complicated or the anticoagulant from being wasted.
[0259] <<The 12th aspect>> The 12th aspect is any one of the 1st aspect to the 11th aspect, Further including a composition liquid level detection step of detecting the liquid level of the composition held in the composition holding part.
[0260] Since the liquid level of the composition is detected by the liquid level detection device, it is possible to obtain the amount of the anticoagulant introduced into the composition holding part and the amount of the composition remaining in the composition holding part, and the chemical solution supply device can be appropriately controlled.
[0261] <<The 13th aspect>> The 13th aspect is any one of the 1st aspect to the 12th aspect, Further including an empty detection step of detecting that the composition has become empty in the composition holding part.
[0262] Since it is possible to detect that the composition is empty by the empty detection device, it is possible to appropriately determine whether the anticoagulant should be introduced into the composition holding part, whether the derivation of the composition should be stopped, etc.
[0263] <<The 14th aspect>> The 14th aspect is any one of the 1st aspect to the 13th aspect, A diluent introduction step of introducing a diluent (for example, a priming solution, etc.) into the composition holding part; Further includes a dilution holding step of holding the composition diluted with the introduced diluent in the composition holding part.
[0264] Not only an anticoagulant but also a diluent can be introduced into the composition holding part. By introducing a diluent into the anticoagulant introduced into the composition holding part, the anticoagulant can be diluted in the composition holding part, and the diluted anticoagulant can be held in the composition holding part as a composition.
[0265] <<15th Aspect>> The 15th aspect is any one of the 1st aspect to the 14th aspect, An introduction step of introducing the anticoagulant accommodated in the container into the composition holding part through a first communication part (for example, an extension part 113, a first lower end opening 316, etc.) that communicates the container and the composition holding part; A derivation step of deriving the composition held in the composition holding part to the connection part through a second communication part (for example, a lower end opening 116, a second lower end opening 318, etc.) that communicates the composition holding part and the connection part.
[0266] By separately providing a path through which the anticoagulant flows and a path through which the composition and the diluent flow with the composition holding part in between, the state of the concentration, cleanliness, etc. of the anticoagulant accommodated in the container can be kept constant.
[0267] <<16th Aspect>> The 16th aspect is any one of the 1st aspect to the 15th aspect, A diluent introduction step of introducing a diluent into the composition holding part through the second communication part; A composition derivation step of deriving the composition to the connection part through the second communication part.
[0268] The second communication part can be shared in both the diluent introduction step and the composition derivation step. The diluent introduction step is a step of introducing a diluent into the composition holding part through a connecting part. The composition derivation step is a step of deriving a composition into the connecting part through the connecting part. By sharing the second communication part, the configuration can be simplified.
[0269] <<The 17th aspect>> The 17th aspect is in any one of the 1st aspect to the 16th aspect, further includes a liquid flow control step of controlling the flow of the liquid in the blood circuit by deformation of a diaphragm of a diaphragm pump (for example, the diaphragm pump 130, etc.).
[0270] Since a diaphragm pump of the blood circuit is used to control the flow of the liquid in the blood circuit, a diluent can be introduced into the composition holding part or a composition can be derived into the connecting part without separately providing a driving device for controlling the flow of the liquid. By sharing the diaphragm pump, the configuration of the chemical solution supply device can be simplified.
[0271] <<The 18th aspect>> The 18th aspect is in any one of the 1st aspect to the 17th aspect, a dropping step of separating the continuously flowing composition into independent droplets and dropping them by the action of gravity, and a dropped composition detection step of detecting the dropped composition, are further included.
[0272] Since a member that is usually provided or commonly used in a dialysis facility or the like can be used to derive the composition from the composition holding part into the blood circuit, the chemical solution supply device can be configured easily and simply.
[0273] <<The 19th aspect>> The 19th aspect is in any one of the 1st aspect to the 18th aspect, A liquid flow control step of controlling the flow of the liquid in the extension part is further included, which is caused by the deformation of a diaphragm of a diaphragm pump (for example, the diaphragm pump 330, etc.) provided in an extension part that is separated from the composition holding part and through which air can flow.
[0274] Even when the blood circuit does not have a driving device such as a diaphragm pump, by separately adding a diaphragm pump to the blood circuit, it can be configured to enable the introduction of an anticoagulant, the introduction of a diluent, and the derivation of a composition.
Industrial Applicability
[0275] To provide a chemical solution supply device that is not limited to the packaging material of chemical solutions such as heparin and can be used for multiple treatments with the chemical solution in the packaging unit.
Explanation of Signs
[0276] 10A, 10B, 10C Chemical solution supply device 20 Dialyzer 60 Dialysis device main body 70 Blood purification device 110 Pipette 130 Diaphragm pump 140 Liquid level adjustment pump
Claims
1. A chemical solution supply device for supplying a chemical solution to a blood circuit of a blood purification device for purifying blood, a composition holding part capable of introducing an anticoagulant contained in a container from the container and holding a composition containing at least the introduced anticoagulant; a connecting part that connects the composition holding part to the blood circuit and enables the composition to be led out from the composition holding part to the blood circuit; A chemical solution supply device comprising:
2. The chemical solution supply device according to claim 1, wherein the liquid level of the composition held in the composition holding part is detected using a liquid level detection device.
3. The chemical solution supply device according to claim 1, wherein it is detected using an empty detection device that the composition in the composition holding part has become empty.
4. a diluent can be introduced into the composition holding part, The chemical solution supply device according to claim 1, wherein the composition diluted with the introduced diluent can be held in the composition holding part.
5. A first communication part that communicates the container and the composition holding part, the first communication part enabling the anticoagulant contained in the container to be introduced into the composition holding part; The chemical solution supply device according to claim 1, further comprising a second communication part that communicates the composition holding part and the connecting part, the second communication part enabling the composition held in the composition holding part to be led out to the connecting part.
6. The second communication part has a diluent introduction state in which a diluent is introduced into the composition holding part, and a composition derivation state in which the composition is led out to the connecting part. The chemical solution supply device according to claim 5.
7. The chemical solution supply device according to claim 1, wherein the blood circuit further comprises a diaphragm pump that controls the flow of liquid in the blood circuit by deforming a diaphragm.
8. further comprising a dropping chamber that separates the continuously flowing composition into independent droplets and drops the droplets by the action of gravity, The chemical solution supply device according to claim 1, wherein the composition dropped from the dropping chamber is detected using a dropping sensor.
9. The chemical solution supply device according to claim 1, wherein an extension part separated from the composition holding part has a diaphragm pump that controls the flow of air in the extension part by deforming a diaphragm.
10. The first communication part has a protruding part having a long cylindrical shape. The drug solution supplying device according to claim 5 , wherein the protrusion has an opening that can be inserted into a through hole of the container and is provided at a tip end that is furthest from the composition holding portion.
11. A method for supplying a medicinal liquid to a blood circuit of a blood purification device that purifies blood, comprising: an anticoagulant introduction step of introducing an anticoagulant contained in a container from the container into a composition holding part; a composition holding step of holding a composition containing at least an anticoagulant introduced into the composition holding portion in the composition holding portion; a composition discharge step of discharging the composition from the composition holding portion to the blood circuit via a connection portion that connects the composition holding portion to the blood circuit; A chemical solution supply method comprising:
12. The method for supplying a chemical solution according to claim 11, further comprising a composition liquid level detection step of detecting a liquid level of the composition held in the composition holding section.
13. The method for supplying a chemical solution according to claim 11, further comprising an empty detection step of detecting that the composition holding section is empty of the composition.
14. A diluent introduction step of introducing a diluent into the composition holding portion; The chemical solution supply method according to claim 11, further comprising a dilution and retention step of retaining the composition diluted with the introduced diluent in the composition retention section.
15. an introduction step of introducing an anticoagulant contained in a container into the composition holding portion through a first communication portion that communicates between the container and the composition holding portion; The drug solution supply method according to claim 11, further comprising a discharge step of discharging the composition held in the composition holding portion to the connecting portion via a second connecting portion that connects the composition holding portion to the connecting portion.
16. A diluent introduction step of introducing a diluent into the composition holding portion through the second communication portion; The drug solution supply method according to claim 15, further comprising a composition leading step of leading the composition to the connecting portion through the second communication portion.
17. 12. The drug solution supplying method according to claim 11, further comprising a liquid flow control step of controlling the flow of liquid in the blood circuit by deformation of a diaphragm of a diaphragm pump.
18. A dropping step of separating the continuously flowing composition into independent droplets and dropping them by the action of gravity; The drug solution supplying device according to claim 11, further comprising a dropped composition detecting step of detecting the dropped composition.
19. The chemical liquid supply method according to claim 11, further comprising a liquid flow control step of controlling the flow of air in the extending portion by deformation of a diaphragm of a diaphragm pump provided in an extending portion that is separated from the composition holding portion and through which air can flow.
Citation Information
Patent Citations
Blood treatment systems and methods
JP2021118944A